volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
11368227|NCT00737594|BG000|Baseline|Placebo|Placebo: 0 mcg capsules three times daily (TID)
11368228|NCT00737594|BG001|Baseline|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
11368229|NCT00737594|BG002|Baseline|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
11368230|NCT00737594|BG003|Baseline|Total|Total of all reporting groups
11368231|NCT00737594|FG000|Participant Flow|Placebo|Placebo: 0 mcg capsules three times daily (TID)
11368232|NCT00737594|FG001|Participant Flow|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
11368233|NCT00737594|FG002|Participant Flow|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
11368234|NCT00737594|OG000|Outcome|Placebo|Placebo: 0 mcg capsules three times daily (TID)
11368235|NCT00737594|OG001|Outcome|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
11368236|NCT00737594|OG002|Outcome|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
11368237|NCT00737594|EG000|Reported Event|Placebo|Placebo: 0 mcg capsules three times daily (TID)
11368238|NCT00737594|EG001|Reported Event|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
11368239|NCT00737594|EG002|Reported Event|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
11368240|NCT00737282|BG000|Baseline|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368241|NCT00737282|BG001|Baseline|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368242|NCT00737282|BG002|Baseline|Total|Total of all reporting groups
11368243|NCT00737282|FG000|Participant Flow|Proellex|"Proellex 25 or 50 mg once daily~One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368244|NCT00737282|OG000|Outcome|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368245|NCT00737282|OG001|Outcome|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368246|NCT00737282|EG000|Reported Event|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368247|NCT00737282|EG001|Reported Event|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
11368248|NCT00739882|BG000|Baseline|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
11368249|NCT00739882|BG001|Baseline|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
11368250|NCT00739882|BG002|Baseline|Total|Total of all reporting groups
11368251|NCT00739882|FG000|Participant Flow|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
11368252|NCT00739882|FG001|Participant Flow|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
11368253|NCT00739882|OG000|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
11368254|NCT00739882|OG001|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
11368255|NCT00739882|EG000|Reported Event|Efalizumab - Double-blind Period|
11368256|NCT00739882|EG001|Reported Event|Placebo - Double-blind Period|
11368257|NCT00739882|EG002|Reported Event|Efalizumab - Open-label Period|
11368258|NCT00739882|EG003|Reported Event|Placebo - Open-label Period|
11368259|NCT00739024|BG000|Baseline|Active Treatment|Random assignment to active treatment
11368260|NCT00739024|BG001|Baseline|Placebo|Random assignment to placebo
11240205|NCT02477215|OG000|Outcome|MLN9708, Bendamustine and Dexamethasone|"Ixazomib 4 mg, days 1, 8, 15.~Dexamethasone 40 mg oral weekly.~Bendamustine dose levels: 80mg/m2 days 1,2~MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 80mg/m2 days 1,2"
11240206|NCT02477215|OG000|Outcome|MLN9708, Bendamustine and Dexamethasone|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 80 mg/m^2 days 1,2"
11368261|NCT00739024|BG002|Baseline|Total|Total of all reporting groups
11368262|NCT00739024|FG000|Participant Flow|Active Treatment|Random assignment to active treatment
11368263|NCT00739024|FG001|Participant Flow|Placebo|Random assignment to placebo
11368264|NCT00739024|OG000|Outcome|Active Treatment|Random assignment to active treatment
11368265|NCT00739024|OG001|Outcome|Placebo|Random assignment to placebo
11368266|NCT00739024|EG000|Reported Event|Active Treatment|Random assignment to active treatment
11368267|NCT00739024|EG001|Reported Event|Placebo|Random assignment to placebo
11368268|NCT00731770|BG000|Baseline|Placebo, Then Advair 250- Matched|1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks
11240207|NCT02477215|OG000|Outcome|Bendamustine (70 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 70 mg/m^2 days 1 and 2"
11368269|NCT00731770|BG001|Baseline|Advair 250, Then Placebo- Matched|1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks
11368270|NCT00731770|BG002|Baseline|Total|Total of all reporting groups
11368271|NCT00731770|FG000|Participant Flow|Placebo, Then Advair 250- Matched|1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.
11368272|NCT00731770|FG001|Participant Flow|Advair 250, Then Palcebo- Matched|1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.
11368273|NCT00731770|OG000|Outcome|Placebo, Then Advair 250- Matched|1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.
11368274|NCT00731770|OG001|Outcome|Advair 250, Then Palcebo- Matched|1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.
11368275|NCT00731770|OG000|Outcome|Placebo, Then Advair 250- Matched|"1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.~Advair 250: 1 puff bid inhaled~Placebo- matched: 1 puff bid inhaled"
11368276|NCT00731770|OG001|Outcome|Advair 250, Then Placebo- Matched|"1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.~Placebo: Placebo 1 puff bid inhaled~Advair 250 - matched: i puff bid inhaled"
11368277|NCT00731770|EG000|Reported Event|Placebo|1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.
11368278|NCT00731770|EG001|Reported Event|Advair 250|1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two wee
11368279|NCT00735254|BG000|Baseline|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
11368280|NCT00735254|BG001|Baseline|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
11368281|NCT00735254|BG002|Baseline|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
11368282|NCT00735254|BG003|Baseline|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
11368283|NCT00735254|BG004|Baseline|Total|Total of all reporting groups
11368284|NCT00735254|FG000|Participant Flow|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
11368285|NCT00735254|FG001|Participant Flow|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
11368286|NCT00735254|FG002|Participant Flow|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
11368287|NCT00735254|FG003|Participant Flow|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
11368288|NCT00735254|OG000|Outcome|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
11368289|NCT00735254|OG001|Outcome|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
11368290|NCT00735254|OG002|Outcome|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
11368291|NCT00735254|OG003|Outcome|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
11368292|NCT00735254|EG000|Reported Event|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
11368293|NCT00735254|EG001|Reported Event|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
11368294|NCT00735254|EG002|Reported Event|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
11368295|NCT00735254|EG003|Reported Event|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
11368296|NCT00729365|BG000|Baseline|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
11368297|NCT00729365|BG001|Baseline|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
11368298|NCT00729365|BG002|Baseline|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
11368299|NCT00729365|BG003|Baseline|Total|Total of all reporting groups
11368300|NCT00729365|FG000|Participant Flow|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
11368301|NCT00729365|FG001|Participant Flow|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
11368302|NCT00729365|FG002|Participant Flow|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
11368303|NCT00729365|OG000|Outcome|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
11368304|NCT00729365|OG001|Outcome|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
11368305|NCT00729365|OG002|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
11368306|NCT00729365|OG000|Outcome|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
11368307|NCT00729365|OG001|Outcome|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
11368308|NCT00729365|EG000|Reported Event|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
11368309|NCT00729365|EG001|Reported Event|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
11240208|NCT02477215|OG001|Outcome|Bendamustine (80 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 80 mg/m^2 days 1 and 2"
11240209|NCT02477215|OG002|Outcome|Bendamustine (90 mg/m^2), MLN9708, Dexamethasone|"MLN9708 : 4 mg, days 1, 8, 15.~Dexamethasone: 40 mg oral weekly.~Bendamustine: 90 mg/m^2 days 1 and 2"
11368310|NCT00729365|EG002|Reported Event|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
11368311|NCT00732680|BG000|Baseline|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
11368312|NCT00732680|FG000|Participant Flow|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
11368313|NCT00732680|OG000|Outcome|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
11368314|NCT00732680|EG000|Reported Event|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
11368315|NCT00726180|BG000|Baseline|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
11368316|NCT00726180|FG000|Participant Flow|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
11368317|NCT00726180|OG000|Outcome|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
10962748|NCT00868296|OG001|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
10962749|NCT00868296|EG000|Reported Event|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
10962750|NCT00868296|EG001|Reported Event|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
10962751|NCT00868309|BG000|Baseline|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
10962752|NCT00868309|BG001|Baseline|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
10962753|NCT00868309|BG002|Baseline|Total|Total of all reporting groups
10962754|NCT00868309|FG000|Participant Flow|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
10962755|NCT00868309|FG001|Participant Flow|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
11189497|NCT02120287|FG000|Participant Flow|BZ-SRS With Bevacizumab|All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
11189498|NCT02120287|OG000|Outcome|BZ-SRS With Bevacizumab|All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
11189499|NCT02120287|EG000|Reported Event|BZ-SRS With Bevacizumab|All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
10962756|NCT00868309|OG000|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
10962757|NCT00868309|OG001|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
11189500|NCT02120300|BG000|Baseline|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
11189501|NCT02120300|BG001|Baseline|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
11189502|NCT02120300|BG002|Baseline|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
10962758|NCT00868309|EG000|Reported Event|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
10962759|NCT00868309|EG001|Reported Event|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
10962760|NCT00868348|BG000|Baseline|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
10962761|NCT00868348|BG001|Baseline|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
10962762|NCT00868348|BG002|Baseline|Total|Total of all reporting groups
10962763|NCT00868348|FG000|Participant Flow|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
10962764|NCT00868348|FG001|Participant Flow|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
10962765|NCT00868348|OG000|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
10962766|NCT00868348|OG001|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
10962767|NCT00868348|EG000|Reported Event|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
10962768|NCT00868348|EG001|Reported Event|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
10962769|NCT00868374|BG000|Baseline|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962770|NCT00868374|BG001|Baseline|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962771|NCT00868374|BG002|Baseline|Total|Total of all reporting groups
10962772|NCT00868374|FG000|Participant Flow|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962773|NCT00868374|FG001|Participant Flow|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962774|NCT00868374|OG000|Outcome|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962775|NCT00868374|OG001|Outcome|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962776|NCT00868374|EG000|Reported Event|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962777|NCT00868374|EG001|Reported Event|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
10962778|NCT00868439|BG000|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962779|NCT00868439|BG001|Baseline|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962780|NCT00868439|BG002|Baseline|Total|Total of all reporting groups
10962781|NCT00868439|FG000|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962782|NCT00868439|FG001|Participant Flow|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962783|NCT00868439|OG000|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
11189503|NCT02120300|BG003|Baseline|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
10962784|NCT00868439|OG001|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962785|NCT00868439|EG000|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962786|NCT00868439|EG001|Reported Event|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
10962787|NCT00868452|BG000|Baseline|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
10962788|NCT00868452|BG001|Baseline|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
10962789|NCT00868452|BG002|Baseline|Total|Total of all reporting groups
10962790|NCT00868452|FG000|Participant Flow|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
10962791|NCT00868452|FG001|Participant Flow|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
10962792|NCT00868452|OG000|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
10962793|NCT00868452|OG001|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
11368318|NCT00726180|EG000|Reported Event|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
11368319|NCT00724282|BG000|Baseline|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
11368320|NCT00724282|FG000|Participant Flow|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
11368321|NCT00724282|OG000|Outcome|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
11368322|NCT00724282|EG000|Reported Event|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
11368323|NCT00730886|BG000|Baseline|ExAblate Treatment:|All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.
11368324|NCT00730886|BG001|Baseline|Myomectomy Treatment:|All patients who had more than 15 grams of fibroid tissue excised.
11368325|NCT00730886|BG002|Baseline|Total|Total of all reporting groups
11368326|NCT00730886|FG000|Participant Flow|ExAblate Treatment:|All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.
11368327|NCT00730886|FG001|Participant Flow|Myomectomy Treatment:|All patients who had more than 15 grams of fibroid tissue excised.
11368328|NCT00730886|OG000|Outcome|ExAblate Treatment:|All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.
11368329|NCT00730886|OG001|Outcome|Myomectomy Treatment:|All patients who had more than 15 grams of fibroid tissue excised.
11368330|NCT00730886|EG000|Reported Event|ExAblate Treatment:|All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.
10962794|NCT00868452|OG000|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
11189504|NCT02120300|BG004|Baseline|Total|Total of all reporting groups
11368331|NCT00730886|EG001|Reported Event|Myomectomy Treatment:|All patients who had more than 15 grams of fibroid tissue excised.
11368332|NCT00728845|BG000|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368333|NCT00728845|BG001|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368334|NCT00728845|BG002|Baseline|Total|Total of all reporting groups
11368335|NCT00728845|FG000|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368336|NCT00728845|FG001|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368337|NCT00728845|OG000|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368338|NCT00728845|OG001|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368339|NCT00728845|EG000|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368340|NCT00728845|EG001|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
11368341|NCT00726830|BG000|Baseline|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
11368342|NCT00726830|BG001|Baseline|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
11368343|NCT00726830|BG002|Baseline|Total|Total of all reporting groups
11368344|NCT00726830|FG000|Participant Flow|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
11368345|NCT00726830|FG001|Participant Flow|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
11368346|NCT00726830|OG000|Outcome|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
11368347|NCT00726830|OG001|Outcome|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
11368348|NCT00726830|EG000|Reported Event|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
11368349|NCT00726830|EG001|Reported Event|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
11368350|NCT00726037|BG000|Baseline|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
11368351|NCT00726037|FG000|Participant Flow|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
11368352|NCT00726037|OG000|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
11368353|NCT00726037|EG000|Reported Event|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
11368354|NCT00729560|BG000|Baseline|Flutamide Treated and Placebo Control|Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
11368355|NCT00729560|FG000|Participant Flow|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
11368356|NCT00729560|OG000|Outcome|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
11368357|NCT00729560|EG000|Reported Event|Flutamide Treated and Placebo Control Subjects|Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
11368358|NCT00716807|BG000|Baseline|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
10962795|NCT00868452|EG000|Reported Event|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
10962796|NCT00868452|EG001|Reported Event|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
11368359|NCT00716807|BG001|Baseline|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368360|NCT00716807|BG002|Baseline|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368361|NCT00716807|BG003|Baseline|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368362|NCT00716807|BG004|Baseline|Total|Total of all reporting groups
11368363|NCT00716807|FG000|Participant Flow|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368364|NCT00716807|FG001|Participant Flow|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368365|NCT00716807|FG002|Participant Flow|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368366|NCT00716807|FG003|Participant Flow|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368367|NCT00716807|OG000|Outcome|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368368|NCT00716807|OG001|Outcome|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368369|NCT00716807|OG002|Outcome|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368370|NCT00716807|OG003|Outcome|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368371|NCT00716807|EG000|Reported Event|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368372|NCT00716807|EG001|Reported Event|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368373|NCT00716807|EG002|Reported Event|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
11368374|NCT00716807|EG003|Reported Event|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
11368375|NCT00714948|BG000|Baseline|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
11368376|NCT00714948|FG000|Participant Flow|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
11368377|NCT00714948|OG000|Outcome|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
11368378|NCT00714948|EG000|Reported Event|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
11368379|NCT00720343|BG000|Baseline|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
11368380|NCT00720343|FG000|Participant Flow|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
11368381|NCT00720343|OG000|Outcome|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
11368382|NCT00720343|OG001|Outcome|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
11368383|NCT00720343|EG000|Reported Event|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
11368384|NCT00720343|EG001|Reported Event|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
11368385|NCT00719914|BG000|Baseline|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
11368386|NCT00719914|BG001|Baseline|Bolus of Normal Saline|Intra-coronary injection of normal saline.
11368387|NCT00719914|BG002|Baseline|Total|Total of all reporting groups
11368388|NCT00719914|FG000|Participant Flow|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
11368389|NCT00719914|FG001|Participant Flow|Bolus of Normal Saline|Intracoronary injection of normal saline.
11368390|NCT00719914|OG000|Outcome|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
11368391|NCT00719914|OG001|Outcome|Bolus of Normal Saline|Intra-coronary injection of normal saline.
11368392|NCT00719914|EG000|Reported Event|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
11368393|NCT00719914|EG001|Reported Event|Bolus of Normal Saline|Intra-coronary injection of normal saline.
11368394|NCT00718640|BG000|Baseline|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
11368395|NCT00718640|FG000|Participant Flow|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
11368396|NCT00718640|OG000|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
11368397|NCT00718640|EG000|Reported Event|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
11368398|NCT00720083|BG000|Baseline|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368399|NCT00720083|BG001|Baseline|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368400|NCT00720083|BG002|Baseline|Total|Total of all reporting groups
11368401|NCT00720083|FG000|Participant Flow|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368402|NCT00720083|FG001|Participant Flow|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368403|NCT00720083|OG000|Outcome|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368404|NCT00720083|OG001|Outcome|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368405|NCT00720083|EG000|Reported Event|RT+ Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368406|NCT00720083|EG001|Reported Event|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
11368407|NCT00717275|BG000|Baseline|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
11368408|NCT00717275|FG000|Participant Flow|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
11368409|NCT00717275|OG000|Outcome|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
11368410|NCT00717275|EG000|Reported Event|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
11368411|NCT00708734|BG000|Baseline|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 5 weeks"
11368412|NCT00708734|FG000|Participant Flow|Arm 1|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
11368413|NCT00708734|OG000|Outcome|Composite Measures of Gait and Balance|Measurement of gait and balance using standardized tools
11368414|NCT00708734|EG000|Reported Event|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
11368415|NCT00711087|BG000|Baseline|ARM 1|Subjects randomized to this group will receive placebo.
11368416|NCT00711087|BG001|Baseline|ARM 2|Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
11368417|NCT00711087|BG002|Baseline|Total|Total of all reporting groups
11368418|NCT00711087|FG000|Participant Flow|ARM 2|Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
11368419|NCT00711087|FG001|Participant Flow|ARM 1|Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
11368420|NCT00711087|OG000|Outcome|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
11368421|NCT00711087|OG001|Outcome|ARM 1|Subjects randomized to receive 100 units of BOTOX-A on Days 0 and 90
11368422|NCT00711087|EG000|Reported Event|ARM 2|"Receiving placebo (saline injections)~Saline injection: Group 2-sham saline injections on both Day 0 and Day 90."
11368423|NCT00711087|EG001|Reported Event|ARM 1|"Receiving BOTOX-A~BOTOX-A: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90"
11189505|NCT02120300|FG000|Participant Flow|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
10962797|NCT00868517|BG000|Baseline|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
11368424|NCT00706797|BG000|Baseline|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
11368425|NCT00706797|BG001|Baseline|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
11368426|NCT00706797|BG002|Baseline|Total|Total of all reporting groups
11368427|NCT00706797|FG000|Participant Flow|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
11368428|NCT00706797|FG001|Participant Flow|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
11368429|NCT00706797|OG000|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
11368430|NCT00706797|OG001|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
10962798|NCT00868517|BG001|Baseline|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
11189506|NCT02120300|FG001|Participant Flow|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
11189507|NCT02120300|FG002|Participant Flow|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
11368431|NCT00706797|EG000|Reported Event|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
11368432|NCT00706797|EG001|Reported Event|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
11368433|NCT00713596|BG000|Baseline|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
11368434|NCT00713596|BG001|Baseline|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
11368435|NCT00713596|BG002|Baseline|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
11368436|NCT00713596|BG003|Baseline|Total|Total of all reporting groups
11189508|NCT02120300|FG003|Participant Flow|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
11189509|NCT02120300|OG000|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
11368437|NCT00713596|FG000|Participant Flow|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
11368438|NCT00713596|FG001|Participant Flow|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
11368439|NCT00713596|FG002|Participant Flow|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
11368440|NCT00713596|OG000|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
11368441|NCT00713596|OG001|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
11368442|NCT00713596|OG002|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
11368443|NCT00713596|EG000|Reported Event|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
11368444|NCT00713596|EG001|Reported Event|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
11368445|NCT00713596|EG002|Reported Event|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
11368446|NCT00703885|BG000|Baseline|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Please note that this is a cross-over design with all subjects receiving all three treatments"
11368447|NCT00703885|FG000|Participant Flow|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Sequence of administration not available for subjects"
11368448|NCT00703885|OG000|Outcome|BOLD fMRI|Cross-over design. Each subject receives, on alternate days and in randomized fashion, either low dose, high dose, or placebo
11368449|NCT00703885|OG000|Outcome|Imaging Data for Repeated Measures|"Crossover design. Each subject receives, in randomized order and on different days:~Low dose alprazolam High dose alprazolam Placebo"
11368450|NCT00703885|EG000|Reported Event|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|Alprazolam Low Dose Alprazolam High Dose Placebo
11368451|NCT00703092|BG000|Baseline|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
11368452|NCT00703092|FG000|Participant Flow|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
11368453|NCT00703092|OG000|Outcome|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
11368454|NCT00703092|EG000|Reported Event|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
11368455|NCT00713258|BG000|Baseline|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
11189510|NCT02120300|OG001|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
11189511|NCT02120300|OG002|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
11189512|NCT02120300|OG003|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
11189513|NCT02120300|OG001|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
11189514|NCT02120300|OG002|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
11368456|NCT00713258|BG001|Baseline|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
11368457|NCT00713258|BG002|Baseline|Total|Total of all reporting groups
11368458|NCT00713258|FG000|Participant Flow|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
11368459|NCT00713258|FG001|Participant Flow|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
11368460|NCT00713258|OG000|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
11368461|NCT00713258|OG001|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
11368462|NCT00713258|EG000|Reported Event|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
11240210|NCT02477215|EG000|Reported Event|Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 70 mg/m^2 on days 1 and 2"
11240211|NCT02477215|EG001|Reported Event|Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 80 mg/m^2 on days 1 and 2.~This reporting group includes subjects from both the Dose Escalation and Fixed Dose Phases who received Bendamustine at 80 mg/m^2."
11240212|NCT02477215|EG002|Reported Event|Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone|"MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.~Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.~Bendamustine: 90 mg/m^2 on days 1 and 2"
11240213|NCT02477319|BG000|Baseline|Part A (Cohort 1)|"• Cohort 1: Healthy Controls~Observational"
11240214|NCT02477319|BG001|Baseline|Part A (Cohort 2)|"• Cohort 2: Partial CFTR function (CF class IV/V)~Observational"
11240215|NCT02477319|BG002|Baseline|Part A (Cohort 3)|• Cohort 3: Absent CFTR function (CF Class I/II)
11240216|NCT02477319|BG003|Baseline|Part B|"F508del homozygous CF patients who initiated Lumacaftor/Ivacaftor~Observational (pre/post study)"
11240217|NCT02477319|BG004|Baseline|Total|Total of all reporting groups
11240218|NCT02477319|FG000|Participant Flow|Part A (Cohort 1)|"• Cohort 1: Healthy Controls~Observational"
11240219|NCT02477319|FG001|Participant Flow|Part A (Cohort 2)|"Cohort 2: Partial CFTR function CF (class IV/V)~Observational"
11240220|NCT02477319|FG002|Participant Flow|Part A (Cohort 3)|"Cohort 3: Absent CFTR function CF (Class I/II)~Observational"
11240221|NCT02477319|FG003|Participant Flow|Part B|"F508del homozygous CF patients who initiated Lumacaftor/Ivacaftor~Observational (pre/post study)"
11368463|NCT00713258|EG001|Reported Event|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
11368464|NCT00706329|BG000|Baseline|Deflux|Treatment with Deflux.
11368465|NCT00706329|FG000|Participant Flow|Deflux|Treatment with Deflux.
11368466|NCT00706329|OG000|Outcome|Close Belly Button or Umbilical Hernia|
11240222|NCT02477319|OG000|Outcome|Part A (Cohort 1)|Cohort 1: Healthy Controls Observational
11240223|NCT02477319|OG001|Outcome|Part A (Cohort 2)|Cohort 2: Partial CFTR function (CF class IV/V)
11240224|NCT02477319|OG002|Outcome|Part A (Cohort 3)|Cohort 3: Absent CFTR function (CF class I/II)
11240225|NCT02477319|OG000|Outcome|Part B|Participants who initiated Ivacaftor/Lumacaftor
11240226|NCT02477319|EG000|Reported Event|All Arms/Groups|Adverse Events were not analyzed by Arm/Group.
11240227|NCT02477332|BG000|Baseline|QGE031 24 mg s.c. q4w|ligelizumab 24 mg injection subcutaneous every 4 weeks
11240228|NCT02477332|BG001|Baseline|QGE031 72 mg s.c. q4w|ligelizumab 72 mg injection subcutaneous every 4 weeks
11240229|NCT02477332|BG002|Baseline|QGE031 240 mg s.c. q4w|ligelizumab 240 mg injection subcutaneous every 4 weeks
11240230|NCT02477332|BG003|Baseline|Omalizumab 300 mg s.c. q4w|omalizumab 300 mg injection subcutaneous every 4 weeks
11240231|NCT02477332|BG004|Baseline|Placebo s.c. q4w|placebo injection subcutaneous every 4 weeks
11240232|NCT02477332|BG005|Baseline|QGE031 120 mg s.c. s.d.|ligelizumab 120 mg injection subcutaneous single dose
11240233|NCT02477332|BG006|Baseline|Total|Total of all reporting groups
11240234|NCT02477332|FG000|Participant Flow|QGE031 24 mg s.c. q4w|ligelizumab 24 mg injection subcutaneous every 4 weeks
11240235|NCT02477332|FG001|Participant Flow|QGE031 72 mg s.c. q4w|ligelizumab 72 mg injection subcutaneous every 4 weeks
11240236|NCT02477332|FG002|Participant Flow|QGE031 240 mg s.c. q4w|ligelizumab 240 mg injection subcutaneous every 4 weeks
11240237|NCT02477332|FG003|Participant Flow|Omalizumab 300 mg s.c. q4w|omalizumab 300 mg injection subcutaneous every 4 weeks
11240238|NCT02477332|FG004|Participant Flow|Placebo s.c. q4w|placebo injection subcutaneous every 4 weeks
11240239|NCT02477332|FG005|Participant Flow|QGE031 120 mg s.c. s.d.|ligelizumab 120 mg injection subcutaneous single dose
11240240|NCT02477332|OG000|Outcome|QGE031 24 mg s.c. q4w|ligelizumab 24 mg injection subcutaneous every 4 weeks
11240241|NCT02477332|OG001|Outcome|QGE031 72 mg s.c. q4w|ligelizumab 72 mg injection subcutaneous every 4 weeks
11240242|NCT02477332|OG002|Outcome|QGE031 240 mg s.c. q4w|ligelizumab 240 mg injection subcutaneous every 4 weeks
11240243|NCT02477332|OG003|Outcome|Omalizumab 300 mg s.c. q4w|omalizumab 300 mg injection subcutaneous every 4 weeks
11240244|NCT02477332|OG004|Outcome|Placebo s.c. q4w|placebo injection subcutaneous every 4 weeks
11240245|NCT02477332|OG005|Outcome|QGE031 120 mg s.c. s.d.|ligelizumab 120 mg injection subcutaneous single dose
11240246|NCT02477332|OG004|Outcome|Placebo|placebo injection subcutaneous every 4 week
11240247|NCT02477332|OG004|Outcome|Placebo|
11240248|NCT02477332|EG000|Reported Event|QGE031 24 mg s.c. q4w|ligelizumab 24 mg injection subcutaneous every 4 weeks
11240249|NCT02477332|EG001|Reported Event|QGE031 72 mg s.c. q4w|ligelizumab 72 mg injection subcutaneous every 4 weeks
11240250|NCT02477332|EG002|Reported Event|QGE031 240 mg s.c. q4w|ligelizumab 240 mg injection subcutaneous every 4 weeks
11240251|NCT02477332|EG003|Reported Event|Omalizumab 300 mg s.c. q4w|omalizumab 300 mg injection subcutaneous every 4 weeks
11240252|NCT02477332|EG004|Reported Event|Placebo s.c. q4w|placebo injection subcutaneous every 4 weeks
11240253|NCT02477332|EG005|Reported Event|QGE031 120 mg s.c. s.d.|ligelizumab 120 mg injection subcutaneous single dose
11368467|NCT00706329|EG000|Reported Event|Deflux|Treatment with Deflux.
11368468|NCT00707434|BG000|Baseline|Continuous Glucose Monitoring in ICU|Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
11368469|NCT00707434|FG000|Participant Flow|Continuous Glucose Monitoring Device in ICU|Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
11368470|NCT00707434|OG000|Outcome|Continuous Glucose Monitoring in ICU|Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
11368471|NCT00707434|EG000|Reported Event|Continuous Glucose Monitoring in ICU|Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
11368472|NCT00707161|BG000|Baseline|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
11368473|NCT00707161|FG000|Participant Flow|Treatment Arm (Radiation Therapy & Cisplatin)|All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
11368474|NCT00707161|OG000|Outcome|Treatment Arm (Radiation & Cisplatin)|Group of participants receiving Radiation and Cisplatin.
11368475|NCT00707161|EG000|Reported Event|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
11368476|NCT00704496|BG000|Baseline|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368477|NCT00704496|BG001|Baseline|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368478|NCT00704496|BG002|Baseline|Total|Total of all reporting groups
11368479|NCT00704496|FG000|Participant Flow|Pseudoephedrine|Pseudoephedrine is a 240 mg PO per day
11368480|NCT00704496|FG001|Participant Flow|Placebo|Placebo arm
11368481|NCT00704496|OG000|Outcome|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368482|NCT00704496|OG001|Outcome|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368483|NCT00704496|EG000|Reported Event|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368484|NCT00704496|EG001|Reported Event|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
11368485|NCT00708916|BG000|Baseline|Apremilast|"CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment~CC-10004: 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment"
11368486|NCT00708916|FG000|Participant Flow|Apremilast|CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
11368487|NCT00708916|OG000|Outcome|Apremilast|CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
11368488|NCT00708916|OG000|Outcome|Apremilast|"CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment~CC-10004: 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment"
11368489|NCT00708916|EG000|Reported Event|Apremilast|CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
11368490|NCT00700778|BG000|Baseline|Recombinant Human Chorionic Gonadotropin|"Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.~recombinant human chorionic gonadotropin~microarray analysis~immunohistochemistry staining method~laboratory biomarker analysis~needle biopsy"
11368491|NCT00700778|FG000|Participant Flow|Recombinant Human Chorionic Gonadotropin|"Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.~recombinant human chorionic gonadotropin~microarray analysis~immunohistochemistry staining method~laboratory biomarker analysis~needle biopsy"
11368492|NCT00700778|OG000|Outcome|Recombinant Human Chorionic Gonadotropin|"Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.~recombinant human chorionic gonadotropin~microarray analysis~immunohistochemistry staining method~laboratory biomarker analysis~needle biopsy"
11368493|NCT00700778|EG000|Reported Event|Recombinant Human Chorionic Gonadotropin|"Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.~recombinant human chorionic gonadotropin~microarray analysis~immunohistochemistry staining method~laboratory biomarker analysis~needle biopsy"
11368494|NCT00699842|BG000|Baseline|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368495|NCT00699842|BG001|Baseline|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368496|NCT00699842|BG002|Baseline|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368497|NCT00699842|BG003|Baseline|Total|Total of all reporting groups
11368498|NCT00699842|FG000|Participant Flow|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368499|NCT00699842|FG001|Participant Flow|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368500|NCT00699842|FG002|Participant Flow|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368501|NCT00699842|OG000|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368502|NCT00699842|OG001|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368503|NCT00699842|OG002|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368504|NCT00699842|EG000|Reported Event|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368505|NCT00699842|EG001|Reported Event|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368506|NCT00699842|EG002|Reported Event|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
11368507|NCT00702962|BG000|Baseline|PHASE I: Vorinostat 200mg Carbo 6 (AUC)|"Phase I portion: To determine MTD of Vorinostat when used in combination with other chemotherapy. Start at Vorinostat 200 mg PO QD D1-14; Carbo 6 (AUC) D3; Etoposide 100 mg/m2 D1,2,3; Vorinostat, Carboplatin, Etoposide, SAHA~Vorinostat, Carboplatin, Etoposide: Sequential cohorts of 3-6 patients will be entered to the following dose levels: Level 1 - Days 1-14: Vorinostat 200 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Level 2 - Days 1-14: Vorinostat 300 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2; Level 3: Days 1-14: Vorinostat 400 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each patient."
11368508|NCT00702962|BG001|Baseline|PHASE II: Vorinostat 300mg Carbo 6 (AUC)|"Phase II portion: To determine progression free survival among patients with extensive disease SCLC receiving carboplatin plus etoposide with fixed dose Vorinostat. (Vorinostat, Carboplatin, Etoposide, SAHA)~SAHA: Once the recommended phase II dose has been established and additional 15 patients will be enrolled. Days 1-4 Vorinostat recommended phase II dose po QD;Day 3 Carboplatin 6 AUC; Days 1,2,3 Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each patient. An additional 35 patients on the phase II portion of the trial will be required to achieve the outlined objectives."
11368509|NCT00702962|BG002|Baseline|Total|Total of all reporting groups
11368510|NCT00702962|FG000|Participant Flow|Phase II Portion - Vorinostat 300mg|"Phase 2 is to determine progression free survival among patients with extensive disease SCLC receiving carboplatin plus etoposide with vorinostat.Vorinostat, Carboplatin, Etoposide, SAHA~SAHA: Once the recommended phase II dose has been established and additional 15 patients will be enrolled. Days 1-4 Vorinostat recommended phase II dose po QD;Day 3 Carboplatin 6 AUC; Days 1,2,3 Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each patient. An additional 35 patients on the phase II portion of the trial will be required to achieve the outlined objectives."
11368511|NCT00702962|FG001|Participant Flow|Phase I Portion - Vorinostat 200mg|"Vorinostat 200 mg PO QD D1-14; Carbo 6 (AUC) D3; Etoposide 100 mg/m2 D1,2,3 Vorinostat, Carboplatin, Etoposide, SAHA.~Vorinostat, Carboplatin, Etoposide: Sequential cohorts of 3-6 patients will be entered to the following dose levels: Level 1 - Days 1-14: Vorinostat 200 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Level 2 - Days 1-14: Vorinostat 300 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2; Level 3: Days 1-14: Vorinostat 400 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each patient. Phase I was prematurely closed as an NCI study established the MTD. This study proceeded to Phase II soon after the first participant was enrolled at Dose Level 2 (300mg)."
11368512|NCT00702962|OG000|Outcome|Phase I Dose Escalation of Vorinostat (200-400mg)|"Vorinostat 200 mg PO QD D1-14; Carbo 6 (AUC) D3; Etoposide 100 mg/m2 D1,2,3 Vorinostat, Carboplatin, Etoposide, SAHA~Vorinostat, Carboplatin, Etoposide: Sequential cohorts of 3-6 patients will be entered to the following dose levels: Level 1 - Days 1-14: Vorinostat 200 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Level 2 - Days 1-14: Vorinostat 300 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2; Level 3: Days 1-14: Vorinostat 400 mg po QD; Day 3: Carboplatin 6 AUC; Days 1,2,3: Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each patient."
11368513|NCT00702962|OG000|Outcome|Phase II Vorinostat 300mg With Carboplatin and Etoposide|"Participants with extensive disease SCLC receiving carboplatin, Etoposide, and a fixed dose (300mg) of vorinostat.~Days 1-4 Vorinostat 300mg po QD; Day 3 Carboplatin 6 AUC; Days 1,2,3 Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each participant."
11189515|NCT02120300|EG000|Reported Event|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
11189516|NCT02120300|EG001|Reported Event|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
11189517|NCT02120300|EG002|Reported Event|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
11189518|NCT02120300|EG003|Reported Event|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
11189519|NCT02120417|BG000|Baseline|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189520|NCT02120417|BG001|Baseline|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189521|NCT02120417|BG002|Baseline|Total|Total of all reporting groups
11189522|NCT02120417|FG000|Participant Flow|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189523|NCT02120417|FG001|Participant Flow|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189524|NCT02120417|OG000|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189525|NCT02120417|OG001|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189526|NCT02120417|EG000|Reported Event|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189527|NCT02120417|EG001|Reported Event|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
11189528|NCT02120443|BG000|Baseline|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
11189529|NCT02120443|FG000|Participant Flow|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
11368514|NCT00702962|OG000|Outcome|Phase II Vorinostat 300mg With Carboplatin and Etoposide|Participants with extensive disease small cell lung cancer who receive carboplatin plus etoposide with a fixed dose of vorinostat. Participants will receive: Days 1-4 Vorinostat recommended phase II dose po QD; Day 3 Carboplatin 6 AUC; Days 1,2,3 Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each participant.
11368515|NCT00702962|OG000|Outcome|Phase II Vorinostat 300mg With Carboplatin and Etoposide|Participants with extensive disease SCLC receiving carboplatin, Etoposide, and a fixed dose (300mg) of vorinostat. Participants will receive on Days 1-4 Vorinostat 300mg po QD; Day 3 Carboplatin 6 AUC; Days 1,2,3 Etoposide 100 mg/m2. Treatment cycles will be repeated every 3 weeks. A maximum of 4 cycles will be administered to each participant.
11189530|NCT02120443|OG000|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
11189531|NCT02120443|EG000|Reported Event|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
11189532|NCT02120456|BG000|Baseline|Part 1: LEO 43204 Gel 0.018%|Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
11189533|NCT02120456|BG001|Baseline|Part 1: LEO 43204 Gel 0.025%|Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
11189534|NCT02120456|BG002|Baseline|Part 1: LEO 43204 Gel 0.037%|Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
11189535|NCT02120456|BG003|Baseline|Part 1: LEO 43204 Gel 0.05%|Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
11189536|NCT02120456|BG004|Baseline|Part 1: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
11189537|NCT02120456|BG005|Baseline|Part 1: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
11189538|NCT02120456|BG006|Baseline|Part 2: LEO 43204 Vehicle Gel|Once daily treatment for two consecutive days LEO 43204 vehicle gel
11189539|NCT02120456|BG007|Baseline|Part 2: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days LEO 43204 gel 0.075%
11189540|NCT02120456|BG008|Baseline|Part 2: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days LEO 43204 gel 0.1%
11189541|NCT02120456|BG009|Baseline|Total|Total of all reporting groups
11189542|NCT02120456|FG000|Participant Flow|Part 1: LEO 43204 Gel 0.018%|Once daily treatment for two consecutive days with LEO 43204 gel 0.018% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11189543|NCT02120456|FG001|Participant Flow|Part 1: LEO 43204 Gel 0.025%|Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11189544|NCT02120456|FG002|Participant Flow|Part 1: LEO 43204 Gel 0.037%|Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11189545|NCT02120456|FG003|Participant Flow|Part 1: LEO 43204 Gel 0.05%|Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11189546|NCT02120456|FG004|Participant Flow|Part 1: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11189547|NCT02120456|FG005|Participant Flow|Part 1: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.
11368516|NCT00702962|EG000|Reported Event|Phase II: Vorinostat 300mg With Carboplatin and Etoposide|"Phase 2 objective is to determine progression free survival among patients with extensive disease SCLC receiving carboplatin plus etoposide using an established dose of Vorinostat.~Participants in Phase II received a cycle consisting of the NCI recommended Vorinostat dose with Carboplatin 6 AUC and Etoposide 100 mg/m2. Treatment cycles were repeated every 3 weeks. A maximum of 4 cycles were administered. A total of 35 participants were required for Phase II analysis. The Phase II study closed prematurely due to low accrual. Analysis of the primary and secondary objectives was not possible due to inadequate sample size."
11368517|NCT00702962|EG001|Reported Event|Phase I: Determine MTD Vorinostat (200mg-400mg)|The original purpose of the Phase I portion was to establish the MTD of Vorinostat when provided with other chemotherapy (Carboplatin and Etoposide). Initial dose at 200mg, then 300, to a max of 400 mg. The first cohort at 200 mg did well with no dose limiting toxicities. After the enrollment of the 1st participant into cohort 2, the Phase I study was prematurely closed as concurrent NCI publications had established appropriate dose levels. The phase I portion was closed after the first 3 participants. Analysis of the objectives is not applicable due to premature closing.
11368518|NCT00703534|BG000|Baseline|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
11368519|NCT00703534|BG001|Baseline|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
11368520|NCT00703534|BG002|Baseline|Total|Total of all reporting groups
11368521|NCT00703534|FG000|Participant Flow|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
11368522|NCT00703534|FG001|Participant Flow|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
11368523|NCT00703534|OG000|Outcome|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
11368524|NCT00703534|OG001|Outcome|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
11368525|NCT00703534|EG000|Reported Event|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
11368526|NCT00703534|EG001|Reported Event|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
11368527|NCT00698009|BG000|Baseline|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
11368528|NCT00698009|FG000|Participant Flow|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
11368529|NCT00698009|OG000|Outcome|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
11368530|NCT00698009|EG000|Reported Event|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
11368531|NCT00703339|BG000|Baseline|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
11189548|NCT02120456|FG006|Participant Flow|Part 2: LEO 43204 Vehicle Gel|Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
11368532|NCT00703339|FG000|Participant Flow|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
11368533|NCT00703339|OG000|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
11368534|NCT00703339|EG000|Reported Event|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
11377138|NCT03978091|FG004|Participant Flow|AVYCAZ + ATM 1.5|"2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.~AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum~Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam"
11189549|NCT02120456|FG007|Participant Flow|Part 2: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
11368535|NCT00691444|BG000|Baseline|0.5mg Melatonin|"Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 0.5 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368536|NCT00691444|BG001|Baseline|10mg Melatonin|"Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 10 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368537|NCT00691444|BG002|Baseline|20mg Melatonin|"Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 20 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368538|NCT00691444|BG003|Baseline|Total|Total of all reporting groups
11368539|NCT00691444|FG000|Participant Flow|0.5mg Melatonin|"Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 0.5 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368540|NCT00691444|FG001|Participant Flow|10mg Melatonin|"Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 10 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368541|NCT00691444|FG002|Participant Flow|20mg Melatonin|"Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 20 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368542|NCT00691444|OG000|Outcome|0.5mg Melatonin|"Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 0.5 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368543|NCT00691444|OG001|Outcome|10mg Melatonin|"Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 10 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368544|NCT00691444|OG002|Outcome|20mg Melatonin|"Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 20 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368545|NCT00691444|EG000|Reported Event|0.5mg Melatonin|"Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 0.5 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368546|NCT00691444|EG001|Reported Event|10mg Melatonin|"Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 10 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368547|NCT00691444|EG002|Reported Event|20mg Melatonin|"Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.~Melatonin: Subjects will be given up to 20 mg daily.~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
11368548|NCT00702702|BG000|Baseline|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11368549|NCT00702702|BG001|Baseline|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
11368550|NCT00702702|BG002|Baseline|Placebo|Placebo, 2 placebo capsules daily for 3 months
11368551|NCT00702702|BG003|Baseline|Total|Total of all reporting groups
11368552|NCT00702702|FG000|Participant Flow|All Groups|Proellex 25 mg, 50 mg or placebo
11368553|NCT00702702|OG000|Outcome|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11368554|NCT00702702|OG001|Outcome|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
11368555|NCT00702702|OG002|Outcome|Placebo|Placebo, 2 placebo capsules daily for 3 months
11368556|NCT00702702|EG000|Reported Event|A 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
11368557|NCT00702702|EG001|Reported Event|B 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
11368558|NCT00702702|EG002|Reported Event|C Placebo|Placebo, 2 capsules daily for 3 months
11368559|NCT00693628|BG000|Baseline|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
11368560|NCT00693628|BG001|Baseline|No Shrinker|Patients will receive no shrinker
11368561|NCT00693628|BG002|Baseline|Total|Total of all reporting groups
11368562|NCT00693628|FG000|Participant Flow|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
11368563|NCT00693628|FG001|Participant Flow|No Shrinker|Patients will receive no shrinker
11368564|NCT00693628|OG000|Outcome|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
11368565|NCT00693628|OG001|Outcome|No Shrinker|Patients will receive no shrinker
11368566|NCT00693628|EG000|Reported Event|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
11368567|NCT00693628|EG001|Reported Event|No Shrinker|Patients will receive no shrinker
11368568|NCT00699413|BG000|Baseline|Intervention Arm|nutrition education plus active supplement
11368569|NCT00699413|BG001|Baseline|Control Arm|nutrition education plus inactive supplement
11368570|NCT00699413|BG002|Baseline|Total|Total of all reporting groups
11368571|NCT00699413|FG000|Participant Flow|Intervention Arm|nutrition education plus active supplement
11368572|NCT00699413|FG001|Participant Flow|Control Arm|nutrition education plus inactive supplement
11368573|NCT00699413|OG000|Outcome|Intervention Arm|nutrition education plus active supplement
11368574|NCT00699413|OG001|Outcome|Control Arm|nutrition education plus inactive supplement
11368575|NCT00699413|EG000|Reported Event|Intervention Arm|nutrition education plus active supplement
11368576|NCT00699413|EG001|Reported Event|Control Arm|nutrition education plus inactive supplement
11368577|NCT00691652|BG000|Baseline|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
11368578|NCT00691652|FG000|Participant Flow|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
11368579|NCT00691652|OG000|Outcome|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
11368580|NCT00691652|EG000|Reported Event|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
11368581|NCT00686972|BG000|Baseline|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
11368582|NCT00686972|FG000|Participant Flow|Glucagon Like Peptide 1 -GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
11368583|NCT00686972|OG000|Outcome|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
11368584|NCT00686972|EG000|Reported Event|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
11368585|NCT00693017|BG000|Baseline|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368586|NCT00693017|BG001|Baseline|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368587|NCT00693017|BG002|Baseline|Total|Total of all reporting groups
11377139|NCT03978091|FG005|Participant Flow|AVYCAZ + ATM 2.0|"2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.~AZACTAM: A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum~Ceftazidime-Avibactam: An antibacterial combination product containing ceftazidime and avibactam"
11368588|NCT00693017|FG000|Participant Flow|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368589|NCT00693017|FG001|Participant Flow|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368590|NCT00693017|OG000|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368591|NCT00693017|OG001|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368592|NCT00693017|EG000|Reported Event|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368593|NCT00693017|EG001|Reported Event|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
11368594|NCT00691574|BG000|Baseline|Light Box|"Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.~Enviro-light artificial light box: Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA."
11368595|NCT00691574|BG001|Baseline|Melatonin|"Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.~Melatonin: up to 3 mg, daily, for up to 1 year"
11368596|NCT00691574|BG002|Baseline|Total|Total of all reporting groups
11368597|NCT00691574|FG000|Participant Flow|Light Box|"Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.~Enviro-light artificial light box: Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA."
11368598|NCT00691574|FG001|Participant Flow|Melatonin|"Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.~Melatonin: up to 3 mg, daily, for up to 1 year"
11368599|NCT00691574|OG000|Outcome|Light Box|"Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.~Enviro-light artificial light box: Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA."
11368600|NCT00691574|OG001|Outcome|Melatonin|"Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.~Melatonin: up to 3 mg, daily, for up to 1 year"
11368601|NCT00691574|EG000|Reported Event|Light Box|"Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.~Enviro-light artificial light box: Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA."
11368602|NCT00691574|EG001|Reported Event|Melatonin|"Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.~Melatonin: up to 3 mg, daily, for up to 1 year"
11368603|NCT00692094|BG000|Baseline|Melatonin: 0.025 Mg-0.5 mg (Delay Timing)|"Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."
11368604|NCT00692094|BG001|Baseline|Melatonin: 0.025 mg - 0.5 mg (Advance Timing)|"Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."
11377140|NCT03978091|OG000|Outcome|AVYCAZ IV|2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
11368605|NCT00692094|BG002|Baseline|Melatonin: 0.025 mg - 10 mg (Advance Timing)|"Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368606|NCT00692094|BG003|Baseline|Melatonin: 0.025 mg - 20 mg (Advance Timing)|"Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock."
11368607|NCT00692094|BG004|Baseline|Total|Total of all reporting groups
11368608|NCT00692094|FG000|Participant Flow|Melatonin: 0.025 Mg-0.5 mg (Delay Timing)|"Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."
11368609|NCT00692094|FG001|Participant Flow|Melatonin: 0.025 mg - 0.5 mg (Advance Timing)|"Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368610|NCT00692094|FG002|Participant Flow|Melatonin: 0.025 mg - 10 mg (Advance Timing)|"Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368611|NCT00692094|FG003|Participant Flow|Melatonin: 0.025 mg - 20 mg (Advance Timing)|"Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock."
11368612|NCT00692094|OG000|Outcome|Melatonin: 0.025 Mg-0.5 mg (Delay Timing)|"Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."
11368613|NCT00692094|OG001|Outcome|Melatonin: 0.025 mg - 0.5 mg (Advance Timing)|"Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368614|NCT00692094|OG002|Outcome|Melatonin: 0.025 mg - 10 mg (Advance Timing)|"Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368615|NCT00692094|OG003|Outcome|Melatonin: 0.025 mg - 20 mg (Advance Timing)|"Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock."
11368616|NCT00692094|EG000|Reported Event|Melatonin: 0.025 Mg-0.5 mg (Delay Timing)|"Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock."
11368617|NCT00692094|EG001|Reported Event|Melatonin: 0.025 mg - 0.5 mg (Advance Timing)|"Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock."
11368618|NCT00692094|EG002|Reported Event|Melatonin: 0.025 mg - 10 mg (Advance Timing)|"Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock."
11189550|NCT02120456|FG008|Participant Flow|Part 2: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
11189551|NCT02120456|OG000|Outcome|Part 1: LEO 43204 Gel 0.018%|Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
11189552|NCT02120456|OG001|Outcome|Part 1: LEO 43204 Gel 0.025%|Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
11189553|NCT02120456|OG002|Outcome|Part 1: LEO 43204 Gel 0.037%|Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
11189554|NCT02120456|OG003|Outcome|Part 1: LEO 43204 Gel 0.05%|Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
11189555|NCT02120456|OG004|Outcome|Part 1: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
11189556|NCT02120456|OG005|Outcome|Part 1: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
11189557|NCT02120456|OG000|Outcome|Part 2: LEO 43204 Vehicle Gel|Once daily treatment for two consecutive days LEO 43204 vehicle gel
11189558|NCT02120456|OG001|Outcome|Part 2: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days LEO 43204 gel 0.075%
11189559|NCT02120456|OG002|Outcome|Part 2: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days LEO 43204 gel 0.1%
11189560|NCT02120456|EG000|Reported Event|Part 1: LEO 43204 Gel 0.018%|Once daily treatment for two consecutive days with LEO 43204 gel 0.018%
11189561|NCT02120456|EG001|Reported Event|Part 1: LEO 43204 Gel 0.025%|Once daily treatment for two consecutive days with LEO 43204 gel 0.025%
11189562|NCT02120456|EG002|Reported Event|Part 1: LEO 43204 Gel 0.037%|Once daily treatment for two consecutive days with LEO 43204 gel 0.037%
11189563|NCT02120456|EG003|Reported Event|Part 1: LEO 43204 Gel 0.05%|Once daily treatment for two consecutive days with LEO 43204 gel 0.05%
11189564|NCT02120456|EG004|Reported Event|Part 1: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days with LEO 43204 gel 0.075%
10962799|NCT00868517|BG002|Baseline|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
11189565|NCT02120456|EG005|Reported Event|Part 1: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
11189566|NCT02120456|EG006|Reported Event|Part 2: LEO 43204 Vehicle Gel|Once daily treatment for two consecutive days LEO 43204 vehicle gel
11189567|NCT02120456|EG007|Reported Event|Part 2: LEO 43204 Gel 0.075%|Once daily treatment for two consecutive days LEO 43204 gel 0.075%
11189568|NCT02120456|EG008|Reported Event|Part 2: LEO 43204 Gel 0.1%|Once daily treatment for two consecutive days LEO 43204 gel 0.1%
11189569|NCT02120625|BG000|Baseline|Baseline Demographics|
10962800|NCT00868517|BG003|Baseline|Total|Total of all reporting groups
11189570|NCT02120625|FG000|Participant Flow|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
11189571|NCT02120625|OG000|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
11189572|NCT02120625|EG000|Reported Event|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
11189573|NCT02120664|BG000|Baseline|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
11189574|NCT02120664|BG001|Baseline|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
11189575|NCT02120664|BG002|Baseline|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
11189576|NCT02120664|BG003|Baseline|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
11189577|NCT02120664|BG004|Baseline|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
11189578|NCT02120664|BG005|Baseline|Total|Total of all reporting groups
11189579|NCT02120664|FG000|Participant Flow|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
11189580|NCT02120664|FG001|Participant Flow|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
11189581|NCT02120664|FG002|Participant Flow|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
11189582|NCT02120664|FG003|Participant Flow|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
11189583|NCT02120664|FG004|Participant Flow|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
11189584|NCT02120664|OG000|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
11189585|NCT02120664|OG001|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
11189586|NCT02120664|OG002|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
11189587|NCT02120664|OG003|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
11189588|NCT02120664|OG004|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
11189589|NCT02120664|OG000|Outcome|PiB SUVR Variability|Variability of standardized uptake value ratio (SUVR) for PiB scans in young healthy controls
11189590|NCT02120664|OG001|Outcome|Florbetapir SUVR Variability|Variability of standardized uptake value ratio (SUVR) for florbetapir scans in young healthy controls
11189591|NCT02120664|EG000|Reported Event|Florbetapir Only|Events occurring within 48 hours following florbetapir scans only
11189592|NCT02120664|EG001|Reported Event|PiB Only|Events occurring within 48 hours of PiB scans only
11189593|NCT02120664|EG002|Reported Event|Both|Events occurring within 48 hours of both florbetapir and PiB scans
11368619|NCT00692094|EG003|Reported Event|Melatonin: 0.025 mg - 20 mg (Advance Timing)|"Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.~Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock."
11240254|NCT02477423|BG000|Baseline|Randomized & Blinded - Receiving Antibiotics|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Ampicillin: Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.~Gentamicin: Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization."
11240255|NCT02477423|BG001|Baseline|Randomized & Blinded - Receiving Placebo|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Placebo: Normal saline will be given as placebo for those in the placebo comparator group."
11240256|NCT02477423|BG002|Baseline|Total|Total of all reporting groups
11240257|NCT02477423|FG000|Participant Flow|Randomized & Blinded - Receiving Antibiotics|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Ampicillin: Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.~Gentamicins: Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization."
11240258|NCT02477423|FG001|Participant Flow|Randomized & Blinded - Receiving Placebo|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Placebo: Normal saline will be given as placebo for those in the placebo comparator group."
11240259|NCT02477423|OG000|Outcome|Randomized & Blinded - Receiving Antibiotics|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Ampicillin: Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.~Gentamicins: Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization."
11240260|NCT02477423|OG001|Outcome|Randomized & Blinded - Receiving Placebo|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Placebo: Normal saline will be given as placebo for those in the placebo comparator group."
11240261|NCT02477423|EG000|Reported Event|Randomized & Blinded - Receiving Antibiotics|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Ampicillin: Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.~Gentamicin: Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization."
11240262|NCT02477423|EG001|Reported Event|Randomized & Blinded - Receiving Placebo|"The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.~Placebo: Normal saline will be given as placebo for those in the placebo comparator group."
11240263|NCT02477527|BG000|Baseline|Stribild|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
11240264|NCT02477527|FG000|Participant Flow|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
11368620|NCT00689884|BG000|Baseline|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
11368621|NCT00689884|FG000|Participant Flow|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
11368622|NCT00689884|OG000|Outcome|Chemotherapy Plus Pegfilgrastim|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
11368623|NCT00689884|OG000|Outcome|Group 1|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
11368624|NCT00689884|EG000|Reported Event|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
11368625|NCT00692003|BG000|Baseline|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368626|NCT00692003|BG001|Baseline|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368627|NCT00692003|BG002|Baseline|Total|Total of all reporting groups
11368628|NCT00692003|FG000|Participant Flow|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368629|NCT00692003|FG001|Participant Flow|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;~>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368630|NCT00692003|OG000|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368631|NCT00692003|OG001|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368632|NCT00692003|EG000|Reported Event|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368633|NCT00692003|EG001|Reported Event|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
11368634|NCT00678288|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
11368635|NCT00678288|BG001|Baseline|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
11368636|NCT00678288|BG002|Baseline|Total|Total of all reporting groups
11368637|NCT00678288|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
11368638|NCT00678288|FG001|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
11368639|NCT00678288|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
11368640|NCT00678288|OG001|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
11368641|NCT00678288|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
11368642|NCT00678288|EG001|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
11189594|NCT02120664|EG003|Reported Event|Total|Events following Florbetapir (florbetapir only and both)
11368643|NCT00676026|BG000|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
11368644|NCT00676026|FG000|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
11368645|NCT00676026|OG000|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
11368646|NCT00676026|EG000|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
11368647|NCT00689052|BG000|Baseline|Placebo|Patients receiving matching placebo
11368648|NCT00689052|BG001|Baseline|Pramipexole|Patients receiving pramipexole
11368649|NCT00689052|BG002|Baseline|Total|Total of all reporting groups
11368650|NCT00689052|FG000|Participant Flow|Placebo|Patients receive placebo in dose up-titration steps
11240265|NCT02477527|OG000|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
11368651|NCT00689052|FG001|Participant Flow|Pramipexole|Patients receive pramipexole in dose up-titration steps
11368652|NCT00689052|OG000|Outcome|Placebo|Placebo tablets, once daily in the evening
11368653|NCT00689052|OG001|Outcome|Pramipexole|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
11368654|NCT00689052|OG000|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
11368655|NCT00689052|OG001|Outcome|Placebo|Placebo tablets, once daily in the evening
11368656|NCT00689052|EG000|Reported Event|Placebo|
11368657|NCT00689052|EG001|Reported Event|Pramipexole|
11368658|NCT00678574|BG000|Baseline|PMDD Group|Fluoxetine 20 mg daily by mouth for 2-3 months to the PMDD group
11368659|NCT00678574|BG001|Baseline|Healthy Controls|No intervention was provided to the healthy control group.
11368660|NCT00678574|BG002|Baseline|Total|Total of all reporting groups
11368661|NCT00678574|FG000|Participant Flow|PMDD|Participants who qualified as having PMDD received fluoxetine 20 mg daily by mouth for 2-3 months
11368662|NCT00678574|FG001|Participant Flow|Healthy Controls|Participants who did not qualify for a diagnosis of PMDD and did not receive drug treatment.
11368663|NCT00678574|OG000|Outcome|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
11368664|NCT00678574|OG001|Outcome|No Intervention|No intervention was provided in the healthy control group.
11368665|NCT00678574|EG000|Reported Event|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
11368666|NCT00678574|EG001|Reported Event|No Treatment|Healthy controls received no treatment.
11368667|NCT00683917|BG000|Baseline|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
11368668|NCT00683917|BG001|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
11368669|NCT00683917|BG002|Baseline|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
11368670|NCT00683917|BG003|Baseline|Total|Total of all reporting groups
11368671|NCT00683917|FG000|Participant Flow|Proellex All Groups|Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available
11368672|NCT00683917|OG000|Outcome|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
11368673|NCT00683917|OG001|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
11368674|NCT00683917|OG002|Outcome|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
11368675|NCT00683917|EG000|Reported Event|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
11368676|NCT00683917|EG001|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
11368677|NCT00683917|EG002|Reported Event|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
11368678|NCT00688935|BG000|Baseline|Melatonin|"Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.~Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)"
11368679|NCT00688935|FG000|Participant Flow|Melatonin|"Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.~Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)"
11368680|NCT00688935|OG000|Outcome|Melatonin|"Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.~Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)"
11368681|NCT00688935|EG000|Reported Event|Melatonin|"Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.~Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)"
11368682|NCT00685880|BG000|Baseline|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
11368683|NCT00685880|BG001|Baseline|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
11368684|NCT00685880|BG002|Baseline|Total|Total of all reporting groups
11368685|NCT00685880|FG000|Participant Flow|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
11368686|NCT00685880|FG001|Participant Flow|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
11368687|NCT00685880|OG000|Outcome|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
11368688|NCT00685880|OG001|Outcome|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
11240266|NCT02477527|EG000|Reported Event|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.~elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
11368689|NCT00685880|EG000|Reported Event|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
11368690|NCT00685880|EG001|Reported Event|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
11368691|NCT00686036|BG000|Baseline|Vandetanib|Vandetanib 300 mg tablet
11368692|NCT00686036|BG001|Baseline|Placebo|Placebo to match vandetanib 300 mg tablet
11368693|NCT00686036|BG002|Baseline|Total|Total of all reporting groups
11368694|NCT00686036|FG000|Participant Flow|Vandetanib|Vandetanib 300 mg tablet
11368695|NCT00686036|FG001|Participant Flow|Placebo|Placebo to match vandetanib 300 mg tablet
11368696|NCT00686036|OG000|Outcome|Vandetanib|Vandetanib 300 mg tablet
11368697|NCT00686036|OG001|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
11368698|NCT00686036|EG000|Reported Event|Vandetanib|Vandetanib 300 mg tablet
11368699|NCT00686036|EG001|Reported Event|Placebo|Placebo to match vandetanib 300 mg tablet
11368700|NCT00681044|BG000|Baseline|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
11368701|NCT00681044|FG000|Participant Flow|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection (SCC) Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
11368702|NCT00681044|OG000|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
11368703|NCT00681044|EG000|Reported Event|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
11368704|NCT00676455|BG000|Baseline|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
11368705|NCT00676455|FG000|Participant Flow|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
11368706|NCT00676455|OG000|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
11368707|NCT00676455|EG000|Reported Event|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
11368708|NCT00684255|BG000|Baseline|Systemic Sclerosis (SSc)|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
11368709|NCT00684255|FG000|Participant Flow|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
11368710|NCT00684255|OG000|Outcome|Medically Refractory Systemic Lupus Erythematosus (SLE)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
11368711|NCT00684255|OG001|Outcome|Systemic Sclerosis (SSc)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
11336893|NCT03572972|EG003|Reported Event|Warfarin|OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016.
11336894|NCT03572972|EG004|Reported Event|Aspirin|OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016.
11336895|NCT03573206|BG000|Baseline|Treatment Arm|"Cardiva Medical Mid-Bore VVCS for venous femoral access site closure~Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case."
11336896|NCT03573206|FG000|Participant Flow|Treatment Arm|"Cardiva Medical Mid-Bore VVCS for venous femoral access site closure~Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case."
11336897|NCT03573206|OG000|Outcome|Treatment Arm|"Cardiva Medical Mid-Bore VVCS for venous femoral access site closure~Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case."
11336898|NCT03573206|EG000|Reported Event|Treatment Arm|"Cardiva Medical Mid-Bore VVCS for venous femoral access site closure~Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case."
11336899|NCT03573323|BG000|Baseline|Ixekizumab|A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336900|NCT03573323|BG001|Baseline|Guselkumab|During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336901|NCT03573323|BG002|Baseline|Total|Total of all reporting groups
11336902|NCT03573323|FG000|Participant Flow|Ixekizumab|A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336903|NCT03573323|FG001|Participant Flow|Guselkumab|During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336904|NCT03573323|OG000|Outcome|Ixekizumab|A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
11336905|NCT03573323|OG001|Outcome|Guselkumab|During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
11336906|NCT03573323|OG000|Outcome|Ixekizumab|A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336907|NCT03573323|OG001|Outcome|Guselkumab|During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336908|NCT03573323|EG000|Reported Event|Ixekizumab|A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336909|NCT03573323|EG001|Reported Event|Guselkumab|During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
11336910|NCT03573323|EG002|Reported Event|Ixekizumab Post-Treatment Follow Up|Participants who received ixekizumab in the blinded treatment periods entered the post treatment follow up period.
11336911|NCT03573323|EG003|Reported Event|Guselkumab Post-Treatment Follow Up|Participants who received guselkumab in the blinded treatment periods entered the post treatment follow up period.
11336912|NCT03573505|BG000|Baseline|Placebo|Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.
11336913|NCT03573505|BG001|Baseline|BG00011|Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.
11336914|NCT03573505|BG002|Baseline|Total|Total of all reporting groups
11336915|NCT03573505|FG000|Participant Flow|Placebo|Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.
11336916|NCT03573505|FG001|Participant Flow|BG00011|Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.
11336917|NCT03573505|OG000|Outcome|Placebo|Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.
11336918|NCT03573505|OG001|Outcome|BG00011|Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.
11336919|NCT03573505|OG000|Outcome|BG00011|Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.
11336920|NCT03573505|EG000|Reported Event|Placebo|Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.
11336921|NCT03573505|EG001|Reported Event|BG00011|Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.
11336922|NCT03573804|BG000|Baseline|Prone to Supine MRI|"The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.~Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material."
11336923|NCT03573804|FG000|Participant Flow|Prone to Supine MRI|"The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.~Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material."
11336924|NCT03573804|OG000|Outcome|Prone to Supine MRI Evaluated by Radiologist A|Radiologist A, number of participants successfully segmented
11336925|NCT03573804|OG001|Outcome|Prone to Supine MRI Evaluated by Radiologist B|Radiologist B, number of participants successfully segmented
11336926|NCT03573804|OG000|Outcome|Prone Images|Prone MRI images
11336927|NCT03573804|OG001|Outcome|Supine Images|Supine MRI images
11336928|NCT03573804|OG000|Outcome|Prone to Supine MRI|"The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.~Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material."
11336929|NCT03573804|OG000|Outcome|Overall Comfort - Prone Participants.|Quantify the perceived comfort level of the prone MRI as reported by participants.
11336930|NCT03573804|OG001|Outcome|Overall Comfort Participants - Supine|Quantify the perceived comfort level of the supine MRI as reported by participants.
11341598|NCT03685344|BG001|Baseline|Dose Escalation: Loncastuximab Tesirine 120 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11189595|NCT02120716|BG000|Baseline|Health Check-Up of Expectant Moms|"Participants receive computer delivered intervention (Health Check-up for Expectant Moms)~Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan."
11189596|NCT02120716|BG001|Baseline|Time and Attention Matched Control Group|Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
11189597|NCT02120716|BG002|Baseline|Total|Total of all reporting groups
11189598|NCT02120716|FG000|Participant Flow|Health Check-Up of Expectant Moms|"Participants receive computer delivered intervention (Health Check-up for Expectant Moms)~Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan."
11368712|NCT00684255|EG000|Reported Event|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
11368713|NCT00683787|BG000|Baseline|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
11368714|NCT00683787|BG001|Baseline|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368715|NCT00683787|BG002|Baseline|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368716|NCT00683787|BG003|Baseline|Total|Total of all reporting groups
11189599|NCT02120716|FG001|Participant Flow|Time and Attention Matched Control Group|Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
11189600|NCT02120716|OG000|Outcome|Health Check-Up of Expectant Moms|"Participants receive computer delivered intervention (Health Check-up for Expectant Moms)~Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan."
11189601|NCT02120716|OG001|Outcome|Time and Attention Matched Control Group|Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
11189602|NCT02120716|EG000|Reported Event|Health Check-Up of Expectant Moms|"Participants receive computer delivered intervention (Health Check-up for Expectant Moms)~Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan."
11368717|NCT00683787|FG000|Participant Flow|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
11368718|NCT00683787|FG001|Participant Flow|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368719|NCT00683787|FG002|Participant Flow|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368720|NCT00683787|OG000|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
11368721|NCT00683787|OG001|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368722|NCT00683787|OG002|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368723|NCT00683787|EG000|Reported Event|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
11368724|NCT00683787|EG001|Reported Event|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368725|NCT00683787|EG002|Reported Event|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
11368726|NCT00679926|BG000|Baseline|Single Treatment Arm|"Patients taking lopinavir/ritonavir and tenofovir once daily.~Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily"
11368727|NCT00679926|FG000|Participant Flow|Single Treatment Arm|"Patients taking lopinavir/ritonavir and tenofovir once daily.~Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily"
11368728|NCT00679926|OG000|Outcome|Single Treatment Arm|"Patients taking lopinavir/ritonavir and tenofovir once daily.~Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily"
11368729|NCT00679926|OG000|Outcome|Once Daily|"Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.~Once daily: Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily"
11368730|NCT00679926|EG000|Reported Event|Single Treatment Arm|"Patients taking lopinavir/ritonavir and tenofovir once daily.~Lopinavir/ritonavir and tenofovir : Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily"
11368731|NCT00678041|BG000|Baseline|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
11368732|NCT00678041|BG001|Baseline|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
11368733|NCT00678041|BG002|Baseline|Total|Total of all reporting groups
11368734|NCT00678041|FG000|Participant Flow|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
11368735|NCT00678041|FG001|Participant Flow|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
11368736|NCT00678041|OG000|Outcome|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
11368737|NCT00678041|OG001|Outcome|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
11368738|NCT00678041|OG000|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
11368739|NCT00678041|EG000|Reported Event|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
11368740|NCT00678041|EG001|Reported Event|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
11368741|NCT00680316|BG000|Baseline|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
11368742|NCT00680316|BG001|Baseline|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
11368743|NCT00680316|BG002|Baseline|Total|Total of all reporting groups
11368744|NCT00680316|FG000|Participant Flow|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
11368745|NCT00680316|FG001|Participant Flow|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
11368746|NCT00680316|OG000|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
11368747|NCT00680316|OG001|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
11368748|NCT00680316|EG000|Reported Event|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
11368749|NCT00680316|EG001|Reported Event|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
11368750|NCT00681629|BG000|Baseline|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
11368751|NCT00681629|BG001|Baseline|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
11368752|NCT00681629|BG002|Baseline|Total|Total of all reporting groups
11368753|NCT00681629|FG000|Participant Flow|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
11368754|NCT00681629|FG001|Participant Flow|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
11376290|NCT00972478|FG000|Participant Flow|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376291|NCT00972478|FG001|Participant Flow|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11368755|NCT00681629|OG000|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
11368756|NCT00681629|OG001|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
11368757|NCT00681629|EG000|Reported Event|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
11368758|NCT00681629|EG001|Reported Event|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
11368759|NCT00669461|BG000|Baseline|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
11368760|NCT00669461|FG000|Participant Flow|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
11368761|NCT00669461|OG000|Outcome|Lubiprostone|Lubiprostone 24 micrograms po BID given for total of 4 weeks
11368762|NCT00669461|OG000|Outcome|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
11368763|NCT00669461|EG000|Reported Event|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
11368764|NCT00671606|BG000|Baseline|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
11368765|NCT00671606|FG000|Participant Flow|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
11368766|NCT00671606|OG000|Outcome|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
11368767|NCT00671606|EG000|Reported Event|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
11368768|NCT00673309|BG000|Baseline|Growth Hormone Administration|"Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing."
11368769|NCT00673309|BG001|Baseline|Insulin High Dose Administration|"Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Insulin: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed."
11368770|NCT00673309|BG002|Baseline|Oxandrolone Administration|"Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing."
11368771|NCT00673309|BG003|Baseline|Propranolol Administration|"Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing."
11368772|NCT00673309|BG004|Baseline|Itraconazole Administration|"Itraconazole administered throughout hospitalization until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Itraconazole administered throughout hospitalization until 95% wound healing."
11368773|NCT00673309|BG005|Baseline|IGF-1/IGFBP-3 Comparator|"IGF-1/IGFBP-3 administered daily to 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~IGF-1/IGFBP-3 administered until 95% wound healing"
11368774|NCT00673309|BG006|Baseline|Insulin Low Dose Administration|Insulin IV administered continuously through hospitalization to 95% wound healing.
11368775|NCT00673309|BG007|Baseline|Growth Hormone and Propranolol Administration|"Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing.~Includes stable isotope infusion studies."
11368776|NCT00673309|BG008|Baseline|Oxandrolone and Propranolol|"Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing.~Includes stable isotope infusion studies"
11368777|NCT00673309|BG009|Baseline|Control or Placebo|Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies.
11368778|NCT00673309|BG010|Baseline|Total|Total of all reporting groups
11368779|NCT00673309|FG000|Participant Flow|Growth Hormone Administration|"Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing."
11368780|NCT00673309|FG001|Participant Flow|Insulin High Dose Administration|"Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Insulin: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed."
11368781|NCT00673309|FG002|Participant Flow|Oxandrolone Administration|"Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing."
11368782|NCT00673309|FG003|Participant Flow|Propranolol Administration|"Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing."
11368783|NCT00673309|FG004|Participant Flow|Itraconazole Administration|"Itraconazole administered throughout hospitalization until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Itraconazole administered throughout hospitalization until 95% wound healing."
11368784|NCT00673309|FG005|Participant Flow|IGF-1/IGFBP-3 Comparator|"IGF-1/IGFBP-3 administered daily to 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~IGF-1/IGFBP-3 administered until 95% wound healing"
11368785|NCT00673309|FG006|Participant Flow|Insulin Low Dose Administration|Insulin IV administered continuously through hospitalization to 95% wound healing.
11368786|NCT00673309|FG007|Participant Flow|Growth Hormone and Propranolol Administration|"Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing.~Includes stable isotope infusion studies."
11368787|NCT00673309|FG008|Participant Flow|Oxandrolone and Propranolol|"Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing.~Includes stable isotope infusion studies"
11368788|NCT00673309|FG009|Participant Flow|Control or Placebo|Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies.
11368789|NCT00673309|OG000|Outcome|Growth Hormone|"Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing."
11368790|NCT00673309|OG001|Outcome|Insulin High Dose|"Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Insulin High Dose: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed."
11368791|NCT00673309|OG002|Outcome|Oxandrolone|"Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing."
11368792|NCT00673309|OG003|Outcome|Propranolol|"Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing."
11368793|NCT00673309|OG004|Outcome|IGF-1/IGFBP-3|"IGF-1/IGFBP-3 will be administered until 95% wound healing~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~IGF-1/IGFBP-3: Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing"
11368794|NCT00673309|OG005|Outcome|Insulin Low Dose|"Insulin Low Dose will be administered until 95% wound healing.~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Insulin Low Dose: Insulin administered IV until 95% wound healing"
11368795|NCT00673309|OG006|Outcome|Itraconazole|"Itraconazole will be administered until 95% wound healing.~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Itraconazole: Itraconazole administered until 95% wound healing"
11377141|NCT03978091|OG001|Outcome|AVYCAZ CI|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
11368796|NCT00673309|OG007|Outcome|Growth Hormone and Propranolol|"Growth Hormone and Propranolol will be administered until 95% wound healing.~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Growth Hormone and Propranolol: Growth Hormone and Propranolol given until 95% wound healing"
11368797|NCT00673309|OG008|Outcome|Oxandrolone and Propranolol|"Oxandrolone and Propranolol will be administered until 95% wound healing~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Oxandrolone and Propranolol: Oxandrolone and Propranolol"
11368798|NCT00673309|OG009|Outcome|Control/Placebo|"Placebo or Control will be administered until 95% wound healing~Stable Isotope Infusion study: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)~Placebo or Control: Administration of Placebo or Control until 95% wound healing"
11368799|NCT00673309|EG000|Reported Event||unknown - Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.
11368800|NCT00672178|BG000|Baseline|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
11368801|NCT00672178|FG000|Participant Flow|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
11368802|NCT00672178|OG000|Outcome|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
11368803|NCT00672178|EG000|Reported Event|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
11368804|NCT00673595|BG000|Baseline|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
11368805|NCT00673595|BG001|Baseline|Placebo|Participants on this arm will receive placebo tablets for 15 days.
11368806|NCT00673595|BG002|Baseline|Total|Total of all reporting groups
11368807|NCT00673595|FG000|Participant Flow|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
11368808|NCT00673595|FG001|Participant Flow|Placebo|Participants on this arm will receive placebo tablets for 15 days.
11368809|NCT00673595|OG000|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
11368810|NCT00673595|OG001|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
11368811|NCT00673595|EG000|Reported Event|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
11368812|NCT00673595|EG001|Reported Event|Placebo|Participants on this arm will receive placebo tablets for 15 days.
11368813|NCT00673361|BG000|Baseline|"Chemo-Switch Regimen"|
11368814|NCT00673361|FG000|Participant Flow|"Chemo-Switch Regimen"|
11368815|NCT00673361|OG000|Outcome|Terminated Studybefore Accrual Goal|
11368816|NCT00673361|EG000|Reported Event|"Chemo-Switch Regimen"|
11368817|NCT00670631|BG000|Baseline|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
11368818|NCT00670631|FG000|Participant Flow|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
11368819|NCT00670631|OG000|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily & dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.~tandem autologous transplantation: DPACE: dexamethasone 20 mg days 1-4 and 8-11, cisplatin 10 mg/m2 days 1-4, Adriamycin 10 mg/m2 days"
11368820|NCT00670631|OG000|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles."
11368821|NCT00670631|EG000|Reported Event|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
11368822|NCT00668785|BG000|Baseline|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
11368823|NCT00668785|FG000|Participant Flow|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
11368824|NCT00668785|OG000|Outcome|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
11376292|NCT00972478|OG000|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11377142|NCT03978091|OG002|Outcome|ATM IV|2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11336946|NCT03573908|FG003|Participant Flow|Linaclotide 290 µg -> Placebo|Participants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to receive placebo for 4 weeks in the Randomized Withdrawal Period.
11377143|NCT03978091|OG003|Outcome|ATM CI|2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
10962801|NCT00868517|FG000|Participant Flow|True Group Auricular Acupuncture|Received true group auricular acupuncture.
11336947|NCT03573908|FG004|Participant Flow|Linaclotide 290 µg -> Linaclotide 290 µg|Participants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to continue linaclotide 290 µg for 4 weeks in the Randomized Withdrawal Period.
10962802|NCT00868517|FG001|Participant Flow|Sham Group Auricular Acupuncture|Received sham group auricular acupuncture.
10962803|NCT00868517|FG002|Participant Flow|Wait-List Control Group|Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.
11336948|NCT03573908|OG000|Outcome|Placebo|Participants randomized to receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period.
11336949|NCT03573908|OG001|Outcome|Linaclotide 290 µg|Participants randomized to receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period.
11336950|NCT03573908|EG000|Reported Event|Placebo|Participants randomized to receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period.
11336951|NCT03573908|EG001|Reported Event|Linaclotide 290 µg|Participants randomized to receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period.
11336952|NCT03573908|EG002|Reported Event|Linaclotide 290 µg -> Linaclotide 290 µg|Participants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to continue linaclotide 290 µg for 4 weeks in the Randomized Withdrawal Period.
11336953|NCT03573908|EG003|Reported Event|Linaclotide 290 µg -> Placebo|Participants who received linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period were rerandomized to receive placebo for 4 weeks in the Randomized Withdrawal Period.
11336954|NCT03573908|EG004|Reported Event|Placebo -> Linaclotide 290 µg|Participants who received placebo orally once daily for 12 weeks during the Treatment Period were switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.
11336955|NCT03574181|BG000|Baseline|Transdermal Alcohol Sensor|All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of five hours following consumption of alcohol.
11336956|NCT03574181|FG000|Participant Flow|Transdermal Alcohol Sensor|Single-arm study. All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of five hours following consumption of alcohol.
11336957|NCT03574181|OG000|Outcome|Transdermal Alcohol Sensor|Single-arm study. All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of three hours following consumption of alcohol.
11336958|NCT03574181|EG000|Reported Event|Transdermal Alcohol Sensor|Single-arm study. All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of five hours following consumption of alcohol.
11336959|NCT03574441|BG000|Baseline|TegadermTM Only|Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
11336960|NCT03574441|BG001|Baseline|Dressing With TegadermTM Plus Steri-StripTM Bands|Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
11336961|NCT03574441|BG002|Baseline|Dressing With TegadermTM Plus Catheter Support Pad.|Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
11336962|NCT03574441|BG003|Baseline|Total|Total of all reporting groups
11336963|NCT03574441|FG000|Participant Flow|TegadermTM Only|Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
11336964|NCT03574441|FG001|Participant Flow|Dressing With TegadermTM Plus Steri-StripTM Bands|Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
11336965|NCT03574441|FG002|Participant Flow|Dressing With TegadermTM Plus Catheter Support Pad.|Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
11336966|NCT03574441|OG000|Outcome|TegadermTM Only|Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
11336967|NCT03574441|OG001|Outcome|Dressing With TegadermTM Plus Steri-StripTM Bands|Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
11336968|NCT03574441|OG002|Outcome|Dressing With TegadermTM Plus Catheter Support Pad.|Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
11336969|NCT03574441|EG000|Reported Event|TegadermTM Only|Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
11336970|NCT03574441|EG001|Reported Event|Dressing With TegadermTM Plus Steri-StripTM Bands|Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
11336971|NCT03574441|EG002|Reported Event|Dressing With TegadermTM Plus Catheter Support Pad.|Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
11368825|NCT00668785|OG000|Outcome|Ranibizumab|"No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis. Population size was 0.~Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.~ranibizumab: Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator."
11368826|NCT00668785|OG000|Outcome|Ranibizumab|"No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis. Population size was 0~Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.~ranibizumab: Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator."
11368827|NCT00668785|EG000|Reported Event|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
11368828|NCT00673179|BG000|Baseline|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368829|NCT00673179|BG001|Baseline|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368830|NCT00673179|BG002|Baseline|Total|Total of all reporting groups
11368831|NCT00673179|FG000|Participant Flow|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368832|NCT00673179|FG001|Participant Flow|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368833|NCT00673179|OG000|Outcome|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368834|NCT00673179|OG001|Outcome|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368835|NCT00673179|EG000|Reported Event|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
11368836|NCT00673179|EG001|Reported Event|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
11368837|NCT00668265|BG000|Baseline|Quetiapine|Subjects on MMTP receiving quetiapine
11368838|NCT00668265|BG001|Baseline|Placebo|Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
10962804|NCT00868517|OG000|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
11368839|NCT00668265|BG002|Baseline|Total|Total of all reporting groups
11368840|NCT00668265|FG000|Participant Flow|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
11368841|NCT00668265|FG001|Participant Flow|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
11368842|NCT00668265|OG000|Outcome|Quetiapine|
11368843|NCT00668265|OG001|Outcome|Placebo|
11368844|NCT00668265|OG000|Outcome|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
11368845|NCT00668265|OG001|Outcome|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
11368846|NCT00668265|EG000|Reported Event|Quetiapine|Active treatment arm for subjects on MMTP in Su Casa residence
11368847|NCT00668265|EG001|Reported Event|Placebo|Placebo arm for subjects on MMTP in Su Casa Residence
11368848|NCT00660348|BG000|Baseline|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
11368849|NCT00660348|BG001|Baseline|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
11368850|NCT00660348|BG002|Baseline|Total|Total of all reporting groups
11368851|NCT00660348|FG000|Participant Flow|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
11368852|NCT00660348|FG001|Participant Flow|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
11368853|NCT00660348|OG000|Outcome|Morphine|"morphine given traditionally (IV, pill, patch). This is standard of care dosing.~morphine sulfate: This is morphine given in the traditional methods."
11368854|NCT00660348|OG001|Outcome|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
11368855|NCT00660348|EG000|Reported Event|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
11368856|NCT00660348|EG001|Reported Event|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
11368857|NCT00664066|BG000|Baseline|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
11368858|NCT00664066|FG000|Participant Flow|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
11368859|NCT00664066|OG000|Outcome|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
11368860|NCT00664066|EG000|Reported Event|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
11368861|NCT00667017|BG000|Baseline|IMTOX25 at 2mg/m²/Dose|"Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.~RFT5-dgA immunotoxin~fluorescence activated cell sorting~immunohistochemistry staining method"
11368862|NCT00667017|FG000|Participant Flow|IMTOX25 at 2mg/m²/Dose|"Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.~RFT5-dgA immunotoxin~fluorescence activated cell sorting~immunohistochemistry staining method"
11368863|NCT00667017|OG000|Outcome|IMTOX25 at 2mg/m²/Dose|"Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.~RFT5-dgA immunotoxin~fluorescence activated cell sorting~immunohistochemistry staining method"
11368864|NCT00667017|EG000|Reported Event|IMTOX25 at 2mg/m²/Dose|"Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.~RFT5-dgA immunotoxin~fluorescence activated cell sorting~immunohistochemistry staining method"
11368865|NCT00665444|BG000|Baseline|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
11368866|NCT00665444|FG000|Participant Flow|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
11368867|NCT00665444|OG000|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
11368868|NCT00665444|EG000|Reported Event|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
11368869|NCT00656916|BG000|Baseline|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
11368870|NCT00656916|BG001|Baseline|Observation|Comparator group, no intervention.
11368871|NCT00656916|BG002|Baseline|Total|Total of all reporting groups
11368872|NCT00656916|FG000|Participant Flow|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
11368873|NCT00656916|FG001|Participant Flow|Observation|Comparator group, no intervention.
11368874|NCT00656916|OG000|Outcome|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
11368875|NCT00656916|OG001|Outcome|Observation|Comparator group, no intervention.
11368876|NCT00656916|EG000|Reported Event|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
11368877|NCT00656916|EG001|Reported Event|Observation|Comparator group, no intervention.
11368878|NCT00660595|BG000|Baseline|Seroquel|Quetiapine Prolong, oral administration
11368879|NCT00660595|BG001|Baseline|Risperdal|Risperidone, oral administration
10850268|NCT00301067|OG000|Outcome|Cohort 1 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11368880|NCT00660595|BG002|Baseline|Total|Total of all reporting groups
11368881|NCT00660595|FG000|Participant Flow|Seroquel|Quetiapine Prolong, oral administration
11368882|NCT00660595|FG001|Participant Flow|Risperdal|Risperidone, oral administration
11368883|NCT00660595|OG000|Outcome|Seroquel|Quetiapine Prolong, oral administration
11368884|NCT00660595|OG001|Outcome|Risperdal|Risperidone, oral administration
11368885|NCT00660595|EG000|Reported Event|Seroquel|Quetiapine Prolong, oral administration
11368886|NCT00660595|EG001|Reported Event|Risperdal|Risperidone, oral administration
11368887|NCT00661466|BG000|Baseline|5x5-cm Bupivacaine Sponges|"Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Bupivacaine Collagen Sponge"
11368888|NCT00661466|BG001|Baseline|5x5-cm Placebo Sponges|"Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Placebo: placebo"
11368889|NCT00661466|BG002|Baseline|Total|Total of all reporting groups
11368890|NCT00661466|FG000|Participant Flow|5x5-cm Bupivacaine Sponges|"Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Bupivacaine Collagen Sponge"
11368891|NCT00661466|FG001|Participant Flow|5x5-cm Placebo Sponges|"Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Placebo: placebo"
11368892|NCT00661466|OG000|Outcome|5x5-cm Bupivacaine Sponges|"Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Bupivacaine Collagen Sponge"
11368893|NCT00661466|OG001|Outcome|5x5-cm Placebo Sponges|"Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Placebo: placebo"
11368894|NCT00661466|EG000|Reported Event|5x5-cm Bupivacaine Sponges|"Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Bupivacaine Collagen Sponge"
11368895|NCT00661466|EG001|Reported Event|5x5-cm Placebo Sponges|"Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.~Placebo: placebo"
11368896|NCT00646282|BG000|Baseline|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
11368897|NCT00646282|BG001|Baseline|Control|Stable kidney transplant recipients do not receive any drug
11368898|NCT00646282|BG002|Baseline|Total|Total of all reporting groups
11368899|NCT00646282|FG000|Participant Flow|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
11368900|NCT00646282|FG001|Participant Flow|Control|Stable kidney transplant recipients do not receive any drug.
11368901|NCT00646282|OG000|Outcome|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
11368902|NCT00646282|OG001|Outcome|Control|Stable kidney transplant recipients will not receive any drug
11368903|NCT00646282|EG000|Reported Event|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
11368904|NCT00646282|EG001|Reported Event|Control|Stable kidney transplant recipients will not receive any drug
11368905|NCT00657553|BG000|Baseline|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
11368906|NCT00657553|BG001|Baseline|Observation Arm|Patients will be observed for progress over the course of three years.
11368907|NCT00657553|BG002|Baseline|Total|Total of all reporting groups
11368908|NCT00657553|FG000|Participant Flow|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
11368909|NCT00657553|FG001|Participant Flow|Observation Arm|Patients will be observed for progress over the course of three years.
11368910|NCT00657553|OG000|Outcome|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
11368911|NCT00657553|OG001|Outcome|Observation Arm|Patients will be observed for progress over the course of three years.
11368912|NCT00657553|EG000|Reported Event|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
11368913|NCT00657553|EG001|Reported Event|Observation Arm|Patients will be observed for progress over the course of three years.
11189603|NCT02120716|EG001|Reported Event|Time and Attention Matched Control Group|Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
11368914|NCT00655057|BG000|Baseline|Healthy Participants|"Healthy participants will undergo TRODAT-1 SPECT imaging.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368915|NCT00655057|BG001|Baseline|Patients With Depression Without CBT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.~S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368916|NCT00655057|BG002|Baseline|Patients With Depression: CBT and SPECT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.~Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368917|NCT00655057|BG003|Baseline|Total|Total of all reporting groups
11368918|NCT00655057|FG000|Participant Flow|Healthy Participants|"Healthy participants will undergo TRODAT-1 SPECT imaging.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368919|NCT00655057|FG001|Participant Flow|Patients With Depression Without CBT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.~S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11376293|NCT00972478|OG000|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11368920|NCT00655057|FG002|Participant Flow|Patients With Depression: CBT and SPECT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.~Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368921|NCT00655057|OG000|Outcome|Healthy Participants|"Healthy participants will undergo TRODAT-1 SPECT imaging.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368922|NCT00655057|OG001|Outcome|Patients With Depression Without CBT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.~S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368923|NCT00655057|OG002|Outcome|Patients With Depression: CBT and SPECT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.~Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368924|NCT00655057|EG000|Reported Event|Healthy Participants|"Healthy participants will undergo TRODAT-1 SPECT imaging.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368925|NCT00655057|EG001|Reported Event|Patients With Depression Without CBT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.~S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368926|NCT00655057|EG002|Reported Event|Patients With Depression: CBT and SPECT|"Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.~Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.~TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later."
11368927|NCT00648895|BG000|Baseline|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
11368928|NCT00648895|BG001|Baseline|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
11368929|NCT00648895|BG002|Baseline|Total|Total of all reporting groups
11368930|NCT00648895|FG000|Participant Flow|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
11368931|NCT00648895|FG001|Participant Flow|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
11368932|NCT00648895|OG000|Outcome|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
11368933|NCT00648895|OG001|Outcome|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
11368934|NCT00648895|EG000|Reported Event|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
10962805|NCT00868517|OG001|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
11368935|NCT00648895|EG001|Reported Event|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
11368936|NCT00647426|BG000|Baseline|Sorafinb + Docetoxel+Carboplatin|"400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle~Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle"
11368937|NCT00647426|FG000|Participant Flow|Sorafinb + Docetoxel+Carboplatin|"400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle~Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle"
11368938|NCT00647426|OG000|Outcome|Sorefenib +Docetaxel|"400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle~Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle"
11368939|NCT00647426|OG000|Outcome|Sorafenib+Docetaxel|"400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle~Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle"
10962806|NCT00868517|OG002|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
10962807|NCT00868517|EG000|Reported Event|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
10962808|NCT00868517|EG001|Reported Event|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
10962809|NCT00868517|EG002|Reported Event|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
11368940|NCT00647426|EG000|Reported Event|Sorafenib + Docetaxel|"400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle~Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle"
11368941|NCT00645567|BG000|Baseline|Wheelchair Transfer Interventions|Persons with SCI who evaluated wheelchair transfer interventions
11368942|NCT00645567|FG000|Participant Flow|Wheelchair Transfer Interventions|5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
11368943|NCT00645567|OG000|Outcome|Glide n' Go|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
11368944|NCT00645567|OG001|Outcome|Standard Transfer Board|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
11368945|NCT00645567|OG002|Outcome|Easy Reach Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
11368946|NCT00645567|OG003|Outcome|Ryno Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
11368947|NCT00645567|OG004|Outcome|Unassisted Manual Transfer|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
11368948|NCT00645567|EG000|Reported Event|Group 1|persons with SCI
11368949|NCT00637806|BG000|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368950|NCT00637806|BG001|Baseline|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
10962810|NCT00868530|BG000|Baseline|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator's prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
10962811|NCT00868530|FG000|Participant Flow|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator's prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
10962812|NCT00868530|OG000|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator's prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
10962813|NCT00868530|EG000|Reported Event|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator's prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
10962814|NCT00868608|BG000|Baseline|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11368951|NCT00637806|BG002|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368952|NCT00637806|BG003|Baseline|Total|Total of all reporting groups
11368953|NCT00637806|FG000|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
11368954|NCT00637806|FG001|Participant Flow|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
11368955|NCT00637806|FG002|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368956|NCT00637806|FG003|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
11368957|NCT00637806|OG000|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368958|NCT00637806|OG001|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
11368959|NCT00637806|OG002|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368960|NCT00637806|EG000|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368961|NCT00637806|EG001|Reported Event|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
11368962|NCT00637806|EG002|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368963|NCT00637806|EG003|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
11376294|NCT00972478|OG001|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376295|NCT00972478|EG000|Reported Event|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376296|NCT00972478|EG001|Reported Event|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
11376297|NCT00792259|BG000|Baseline|Normal Subjects|Normal Subjects with no known ocular pathology
11376298|NCT00792259|BG001|Baseline|Retinal Disease Subjects|Retinal Disease subjects with ocular pathology
11376299|NCT00792259|BG002|Baseline|Glaucoma Subjects|Glaucoma subjects presented with pathology
11376300|NCT00792259|BG003|Baseline|Total|Total of all reporting groups
11376301|NCT00792259|FG000|Participant Flow|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
11376302|NCT00792259|FG001|Participant Flow|Normal Subjects|Normal subjects with no known ocular pathology
11376303|NCT00792259|FG002|Participant Flow|Glaucoma Subjects|Subjects presented with Glaucoma
11376304|NCT00792259|OG000|Outcome|Normal Subjects|Normal subjects with no known ocular pathology
11376305|NCT00792259|OG001|Outcome|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
11376306|NCT00792259|OG002|Outcome|Glaucoma Subjects|Subjects presented with glaucoma
11376307|NCT00792259|EG000|Reported Event|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
11376308|NCT00792259|EG001|Reported Event|Normal Subjects|Normal subjects with no known ocular pathology
11376309|NCT00792259|EG002|Reported Event|Glaucoma Subjects|Subjects presented with glaucoma
11376310|NCT00662792|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomized, double-blind 4-way cross over study. Patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments (7.5 µg/25 µg Tio/Salmeterol, 18 µg Tiotropium, 50 µg Salmeterol MDPI and 18 µg Tiotropium Free combination). The duration of each treatment period was 6 weeks on average with no washout period between treatments.
11376311|NCT00662792|FG000|Participant Flow|T+S_PE/ Tio18GEL / Salm50DPI / T18GEL+S_DPI|"Period 1: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening.~Period 2: 18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening.~Period 3: One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID), in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning.~Period 4: 18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning.~Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods."
11377144|NCT03978091|OG004|Outcome|AVYCAZ + ATM 1.5|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11189604|NCT02120781|BG000|Baseline|Azficel-T (Autologous Fibroblasts)|"Azficel-T will be injected into the vocal fold(s) three times at two week intervals.~Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.~Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril."
11189605|NCT02120781|BG001|Baseline|Control|"Sterile saline will be injected into the vocal fold(s) three times at two week intervals.~Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s)."
11189606|NCT02120781|BG002|Baseline|Total|Total of all reporting groups
11189607|NCT02120781|FG000|Participant Flow|Azficel-T (Autologous Fibroblasts)|"Azficel-T will be injected into the vocal fold(s) three times at two week intervals.~Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.~Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril."
11189608|NCT02120781|FG001|Participant Flow|Control|"Sterile saline will be injected into the vocal fold(s) three times at two week intervals.~Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s)."
11189609|NCT02120781|OG000|Outcome|Azficel-T (Autologous Fibroblasts)|"Azficel-T will be injected into the vocal fold(s) three times at two week intervals.~Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.~Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril."
11368964|NCT00652457|BG000|Baseline|All Participants|Total of all reporting groups due to age of study. Data was not analyzed per arm.
11368965|NCT00652457|FG000|Participant Flow|Memantine, Then Memantine|Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months.
11368966|NCT00652457|FG001|Participant Flow|Placebo, Then Memantine|Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.
11368967|NCT00652457|OG000|Outcome|Memantine, Then Memantine|Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months.
11368968|NCT00652457|OG001|Outcome|Placebo, Then Memantine|Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.
11368969|NCT00652457|EG000|Reported Event|Memantine, Then Memantine|Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months.
11368970|NCT00652457|EG001|Reported Event|Placebo, Then Memantine|Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.
11368971|NCT00642603|BG000|Baseline|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368972|NCT00642603|BG001|Baseline|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368973|NCT00642603|BG002|Baseline|Total|Total of all reporting groups
11368974|NCT00642603|FG000|Participant Flow|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11189610|NCT02120781|OG001|Outcome|Control|"Sterile saline will be injected into the vocal fold(s) three times at two week intervals.~Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s)."
11368975|NCT00642603|FG001|Participant Flow|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368976|NCT00642603|OG000|Outcome|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11377145|NCT03978091|OG005|Outcome|AVYCAZ + ATM 2.0|2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
11368977|NCT00642603|OG001|Outcome|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368978|NCT00642603|EG000|Reported Event|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368979|NCT00642603|EG001|Reported Event|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
11368980|NCT00629798|BG000|Baseline|Palifermin|"This is a single arm phase II trial to assess the efficacy (decrease the transplant related mortality) and safety of peri-transplant Palifermin in combination with a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with advanced MDS and AML evolved from MDS. The addition of Palifermin is to decrease the toxicity and the infection rate associated with this regimen and transplant type and to foster earlier immune reconstitution.~Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant: Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days"
11368981|NCT00629798|FG000|Participant Flow|Palifermin|"This is a single arm phase II trial to assess the efficacy (decrease the transplant related mortality) and safety of peri-transplant Palifermin in combination with a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with advanced MDS and AML evolved from MDS. The addition of Palifermin is to decrease the toxicity and the infection rate associated with this regimen and transplant type and to foster earlier immune reconstitution.~Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant: Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days"
11368982|NCT00629798|OG000|Outcome|Palifermin|"This is a single arm phase II trial to assess the efficacy (decrease the transplant related mortality) and safety of peri-transplant Palifermin in combination with a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with advanced MDS and AML evolved from MDS. The addition of Palifermin is to decrease the toxicity and the infection rate associated with this regimen and transplant type and to foster earlier immune reconstitution.~Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant: Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days"
11368983|NCT00629798|EG000|Reported Event|Palifermin|"This is a single arm phase II trial to assess the efficacy (decrease the transplant related mortality) and safety of peri-transplant Palifermin in combination with a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with advanced MDS and AML evolved from MDS. The addition of Palifermin is to decrease the toxicity and the infection rate associated with this regimen and transplant type and to foster earlier immune reconstitution.~Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant: Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days"
11368984|NCT00645359|BG000|Baseline|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
11368985|NCT00645359|FG000|Participant Flow|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
11368986|NCT00645359|OG000|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
11368987|NCT00645359|EG000|Reported Event|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
11368988|NCT00637728|BG000|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368989|NCT00637728|BG001|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368990|NCT00637728|BG002|Baseline|Total|Total of all reporting groups
11368991|NCT00637728|FG000|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
11368992|NCT00637728|FG001|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11377146|NCT03978091|EG000|Reported Event|AVYCAZ IV|2.5g dose of ceftazidime-avibactam (AVYCAZ) administered intravenously as a 2-hour infusion, every 8 hours for 7 days.
11368993|NCT00637728|FG002|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
11368994|NCT00637728|OG000|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368995|NCT00637728|OG001|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368996|NCT00637728|EG000|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
11368997|NCT00637728|EG001|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
11368998|NCT00637728|EG002|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
11368999|NCT00639626|BG000|Baseline|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
11369000|NCT00639626|FG000|Participant Flow|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
11369001|NCT00639626|OG000|Outcome|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
11369002|NCT00639626|EG000|Reported Event|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
11369003|NCT00634582|BG000|Baseline|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
11240267|NCT02477553|BG000|Baseline|Verbal|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Verbal"
11369004|NCT00634582|FG000|Participant Flow|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
11369005|NCT00634582|OG000|Outcome|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
11369006|NCT00634582|EG000|Reported Event|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
11369007|NCT00641108|BG000|Baseline|ADAM SPECT|"Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.~ADAM SPECT plus Cognitive Therapy"
11369008|NCT00641108|BG001|Baseline|Control|"Healthy subjects without depression will undergo ADAM SPECT scans.~ADAM SPECT plus No Therapy"
11369009|NCT00641108|BG002|Baseline|Total|Total of all reporting groups
11369010|NCT00641108|FG000|Participant Flow|ADAM SPECT|"Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.~ADAM SPECT plus Cognitive Therapy"
11369011|NCT00641108|FG001|Participant Flow|Control|"Healthy subjects without depression will undergo ADAM SPECT scans.~ADAM SPECT plus No Therapy"
11369012|NCT00641108|OG000|Outcome|ADAM SPECT|"Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.~ADAM SPECT plus Cognitive Therapy"
11369013|NCT00641108|OG001|Outcome|Control|"Healthy subjects without depression will undergo ADAM SPECT scans.~ADAM SPECT plus No Therapy"
11369014|NCT00641108|EG000|Reported Event|ADAM SPECT|"Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.~ADAM SPECT plus Cognitive Therapy"
11369015|NCT00641108|EG001|Reported Event|Control|"Healthy subjects without depression will undergo ADAM SPECT scans.~ADAM SPECT plus No Therapy"
11369016|NCT00642382|BG000|Baseline|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369017|NCT00642382|BG001|Baseline|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369018|NCT00642382|BG002|Baseline|Total|Total of all reporting groups
11369019|NCT00642382|FG000|Participant Flow|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369020|NCT00642382|FG001|Participant Flow|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369021|NCT00642382|OG000|Outcome|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369022|NCT00642382|OG001|Outcome|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11369023|NCT00642382|EG000|Reported Event|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11336972|NCT03574753|BG000|Baseline|ABBV-399|"C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.~ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.~ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days"
11336973|NCT03574753|FG000|Participant Flow|ABBV-399|"C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.~ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.~ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days"
11336974|NCT03574753|OG000|Outcome|ABBV-399|"C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.~ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.~ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days"
11336975|NCT03574753|OG000|Outcome|ABBV-399|"C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.~ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.~ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 daysXXX"
11336976|NCT03574753|EG000|Reported Event|ABBV-399|"C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.~ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.~ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days"
11336977|NCT03574818|BG000|Baseline|Arm 1|"Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).~Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).~The regimen will be given for a total of 3 cycles.~The regimen will be given for a total of 3 cycles.~Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8~Cisplatin 75mg / m2 IV on D1~Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles."
11336978|NCT03574818|FG000|Participant Flow|Arm 1|"Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).~Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).~The regimen will be given for a total of 3 cycles.~The regimen will be given for a total of 3 cycles.~Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8~Cisplatin 75mg / m2 IV on D1~Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles."
11336979|NCT03574818|OG000|Outcome|Arm 1|"Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).~Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).~The regimen will be given for a total of 3 cycles.~The regimen will be given for a total of 3 cycles.~Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8~Cisplatin 75mg / m2 IV on D1~Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles."
11336980|NCT03574818|EG000|Reported Event|Arm 1|"Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).~Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).~The regimen will be given for a total of 3 cycles.~The regimen will be given for a total of 3 cycles.~Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8~Cisplatin 75mg / m2 IV on D1~Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles."
11336981|NCT03575702|BG000|Baseline|Uritos®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Uritos®: film-coated tablets 0.1 mg"
11336982|NCT03575702|BG001|Baseline|Urotol®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Urotol®: film coated tablets, 2 mg"
11336983|NCT03575702|BG002|Baseline|Total|Total of all reporting groups
11336984|NCT03575702|FG000|Participant Flow|Uritos®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Uritos®: film-coated tablets 0.1 mg"
11336985|NCT03575702|FG001|Participant Flow|Urotol®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Urotol®: film coated tablets, 2 mg"
11336986|NCT03575702|OG000|Outcome|Uritos®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Uritos®: film-coated tablets 0.1 mg"
11336987|NCT03575702|OG001|Outcome|Urotol®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Urotol®: film coated tablets, 2 mg"
11336988|NCT03575702|EG000|Reported Event|Uritos®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Uritos®: film-coated tablets 0.1 mg"
11336989|NCT03575702|EG001|Reported Event|Urotol®|"one tablet orally twice a day (after breakfast and dinner) for 12 weeks~Urotol®: film coated tablets, 2 mg"
11336990|NCT03575754|BG000|Baseline|Interventional|"This arm utilizes the investigational device, as specified in protocol.~Percutaneous Ultrasound Gastrostomy: A balloon catheter is inserted into the stomach and used to appose tissue between anterior stomach and skin. Fluid fills the balloon, enabling ultrasound visualization. Then a guidewire is inserted, and pulled out through the mouth to create wire-to-wire (through and through) access. At that point, a gastrostomy tube is placed over it using over-the-wire (push) technique."
11336991|NCT03575754|BG001|Baseline|Matched Retrospective RIG Cohort|Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
11336992|NCT03575754|BG002|Baseline|Total|Total of all reporting groups
11336993|NCT03575754|FG000|Participant Flow|Prospective PUG Cohort|Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure
11336994|NCT03575754|FG001|Participant Flow|Matched Retrospective RIG Cohort|Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
11336995|NCT03575754|OG000|Outcome|Prospective PUG Cohort|Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure
11336996|NCT03575754|OG001|Outcome|Matched Retrospective RIG Cohort|Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
11336997|NCT03575754|EG000|Reported Event|Prospective PUG Cohort|Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure
11336998|NCT03575754|EG001|Reported Event|Matched Retrospective RIG Cohort|Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
11336999|NCT03575806|BG000|Baseline|TACE Group|"Control arm: only TACE~(TACE: transcatheter arterial chemoembolization)"
11337000|NCT03575806|BG001|Baseline|TACE+Tcm Group|"Experimental arm: TACE plus autologous Tcm immunotherapy~(TACE:transcatheter arterial chemoembolization)~Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro."
11337001|NCT03575806|BG002|Baseline|Total|Total of all reporting groups
11337002|NCT03575806|FG000|Participant Flow|TACE Group|"Control arm: only TACE~(TACE: transcatheter arterial chemoembolization)"
11337003|NCT03575806|FG001|Participant Flow|TACE+Tcm Group|"Experimental arm: TACE plus autologous Tcm immunotherapy~(TACE:transcatheter arterial chemoembolization)~Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro."
11337004|NCT03575806|OG000|Outcome|TACE Group|"Control arm: only TACE~(TACE: transcatheter arterial chemoembolization)"
11337005|NCT03575806|OG001|Outcome|TACE+Tcm Group|"Experimental arm: TACE plus autologous Tcm immunotherapy~(TACE:transcatheter arterial chemoembolization)~Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro."
11337006|NCT03575806|EG000|Reported Event|TACE Group|"Control arm: only TACE~(TACE: TACE:transcatheter arterial chemoembolization)"
11337007|NCT03575806|EG001|Reported Event|TACE+Tcm Group|"Experimental arm: TACE plus autologous Tcm immunotherapy~(TACE:transcatheter arterial chemoembolization)~Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro."
11337008|NCT03575871|BG000|Baseline|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337009|NCT03575871|BG001|Baseline|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337010|NCT03575871|BG002|Baseline|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337011|NCT03575871|BG003|Baseline|Total|Total of all reporting groups
11337012|NCT03575871|FG000|Participant Flow|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337013|NCT03575871|FG001|Participant Flow|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337014|NCT03575871|FG002|Participant Flow|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337015|NCT03575871|OG000|Outcome|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11369024|NCT00642382|EG001|Reported Event|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
11337016|NCT03575871|OG001|Outcome|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337017|NCT03575871|OG002|Outcome|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337018|NCT03575871|EG000|Reported Event|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337019|NCT03575871|EG001|Reported Event|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337020|NCT03575871|EG002|Reported Event|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11337021|NCT03575962|BG000|Baseline|All Participants|Eligible participants received a single dose of GSK3640254 200 mg bis-hydrochloride salt (100 mg x 2 capsules) followed by GSK3640254 200 mg mesylate salt (100 mg x 2 capsules) or vice versa, administered orally on Day 1 in each treatment period 1 and 2 following a moderate fat meal. The washout period was of minimum 7 days between the treatment periods.
11337022|NCT03575962|FG000|Participant Flow|GSK3640254 200 Mg-hydrochloride Salt Followed by Mesylate Salt|Eligible participants received a single dose of GSK3640254 200 milligram (mg) bis-hydrochloride salt (100 mg x 2 capsules) administered orally on Day 1 in treatment period 1 after a moderate fat meal. It was followed by a washout period of minimum 7 days. Participants received GSK3640254 200 mg mesylate salt (100 mg x 2 capsules) administered orally on Day 1 in treatment period 2 after a moderate fat meal.
11337023|NCT03575962|FG001|Participant Flow|GSK3640254 200 Mg-mesylate Salt Followed by Hydrochloride Salt|Eligible participants received a single dose of GSK3640254 200 mg mesylate salt (100 mg x 2 capsules) administered orally on Day 1 in treatment period 1 after a moderate fat meal. It was followed by a washout period of minimum 7 days. Participants received GSK3640254 200 mg bis-hydrochloride salt (100 mg x 2 capsules) administered orally on Day 1 in treatment period 2 after a moderate fat meal.
11337024|NCT03575962|OG000|Outcome|GSK3640254 200 mg Hydrochloride Salt|Eligible participants received a single dose of GSK3640254 200 mg bis-hydrochloride salt (100 mg x 2) administered orally on Day 1 in either treatment period 1or 2 as per randomization.
11337025|NCT03575962|OG001|Outcome|GSK3640254 Capsule 200 mg Mesylate Salt|Eligible participants received a single dose of GSK3640254 200 mg mesylate salt (100 mg x 2) administered orally on Day 1 in either treatment period 1or 2 as per randomization.
11337026|NCT03575962|EG000|Reported Event|GSK3640254 200 mg Hydrochloride Salt|Eligible participants received a single dose of GSK3640254 200 mg bis-hydrochloride salt (100 mg x 2) administered orally on Day 1 in either treatment period 1or 2 as per randomization.
11337027|NCT03575962|EG001|Reported Event|GSK3640254 Capsule 200 mg Mesylate Salt|Eligible participants received a single dose of GSK3640254 200 mg mesylate salt (100 mg x 2) administered orally on Day 1 in either treatment period 1or 2 as per randomization.
11337028|NCT03575975|BG000|Baseline|Mobile-bearing Ankle Prosthesis User|"Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337029|NCT03575975|BG001|Baseline|Fixed-bearing Ankle Prosthesis User|"Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337030|NCT03575975|BG002|Baseline|Control|"Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.~No participants were enrolled due to premature study termination."
11337031|NCT03575975|BG003|Baseline|Total|Total of all reporting groups
11337032|NCT03575975|FG000|Participant Flow|Mobile-bearing Ankle Prosthesis User|"Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337033|NCT03575975|FG001|Participant Flow|Fixed-bearing Ankle Prosthesis User|"Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337034|NCT03575975|FG002|Participant Flow|Control|Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
11337035|NCT03575975|OG000|Outcome|Mobile-bearing Ankle Prosthesis User|"Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337036|NCT03575975|OG001|Outcome|Fixed-bearing Ankle Prosthesis User|"Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11369025|NCT00637416|BG000|Baseline|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
11369026|NCT00637416|BG001|Baseline|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
11369027|NCT00637416|BG002|Baseline|Total|Total of all reporting groups
11369028|NCT00637416|FG000|Participant Flow|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
11369029|NCT00637416|FG001|Participant Flow|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
11369030|NCT00637416|OG000|Outcome|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
11369031|NCT00637416|OG001|Outcome|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
11369032|NCT00637416|EG000|Reported Event|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
11369033|NCT00637416|EG001|Reported Event|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
11369034|NCT00635167|BG000|Baseline|Contrast Enhanced Transrectal Ultrasound (TRUS)|Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
11369035|NCT00635167|FG000|Participant Flow|Contrast Enhanced Transrectal Ultrasound (TRUS)|Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
11369036|NCT00635167|OG000|Outcome|Contrast Enhanced Transrectal Ultrasound (TRUS)|Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
11369037|NCT00635167|EG000|Reported Event|Contrast Enhanced Transrectal Ultrasound (TRUS)|Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
11369038|NCT00637312|BG000|Baseline|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
11369039|NCT00637312|BG001|Baseline|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
11369040|NCT00637312|BG002|Baseline|Total|Total of all reporting groups
11369041|NCT00637312|FG000|Participant Flow|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
11369042|NCT00637312|FG001|Participant Flow|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
11369043|NCT00637312|OG000|Outcome|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
11369044|NCT00637312|OG001|Outcome|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
11369045|NCT00637312|EG000|Reported Event|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
11369046|NCT00637312|EG001|Reported Event|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
11369047|NCT00638222|BG000|Baseline|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
11369048|NCT00638222|BG001|Baseline|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
11369049|NCT00638222|BG002|Baseline|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
11369050|NCT00638222|BG003|Baseline|Total|Total of all reporting groups
11369051|NCT00638222|FG000|Participant Flow|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
11369052|NCT00638222|FG001|Participant Flow|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
11369053|NCT00638222|FG002|Participant Flow|All Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
11369054|NCT00638222|OG000|Outcome|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
11369055|NCT00638222|OG001|Outcome|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
11369056|NCT00638222|EG000|Reported Event|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
11369057|NCT00638222|EG001|Reported Event|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
11369058|NCT00638222|EG002|Reported Event|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
11369059|NCT00634322|BG000|Baseline|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
11369060|NCT00634322|BG001|Baseline|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
11369061|NCT00634322|BG002|Baseline|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
11369062|NCT00634322|BG003|Baseline|Total|Total of all reporting groups
11369063|NCT00634322|FG000|Participant Flow|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
11369064|NCT00634322|FG001|Participant Flow|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
11369065|NCT00634322|FG002|Participant Flow|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
11369066|NCT00634322|OG000|Outcome|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
11369067|NCT00634322|OG001|Outcome|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
11369068|NCT00634322|OG002|Outcome|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
11369069|NCT00634322|EG000|Reported Event|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
11369070|NCT00634322|EG001|Reported Event|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
11369071|NCT00634322|EG002|Reported Event|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
11369072|NCT00633087|BG000|Baseline|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
11369073|NCT00633087|FG000|Participant Flow|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
11369074|NCT00633087|OG000|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
11369075|NCT00633087|EG000|Reported Event|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
11369076|NCT00631137|BG000|Baseline|ARM 2 : Treatment Group|"Androgel (10g pouch/day)~testosterone gel :~questionnaire administration :"
11369077|NCT00631137|BG001|Baseline|Arm 1: Control Group|"whey protein powder~questionnaire administration :"
11369078|NCT00631137|BG002|Baseline|Total|Total of all reporting groups
11369079|NCT00631137|FG000|Participant Flow|ARM 2 : Treatment Group|"Androgel (10g pouch/day)~testosterone gel :~questionnaire administration :"
11369080|NCT00631137|FG001|Participant Flow|Arm 1: Control Group|"whey protein powder~questionnaire administration :"
11369081|NCT00631137|OG000|Outcome|ARM 2 : Treatment Group|"Androgel (10g pouch/day)~testosterone gel :~questionnaire administration :"
11369082|NCT00631137|OG001|Outcome|Arm 1: Control Group|"whey protein powder~questionnaire administration :"
11369083|NCT00631137|EG000|Reported Event|ARM 2 : Treatment Group|"Androgel (10g pouch/day)~testosterone gel :~questionnaire administration :"
11369084|NCT00631137|EG001|Reported Event|Arm 1: Control Group|"whey protein powder~questionnaire administration :"
11369085|NCT00634972|BG000|Baseline|1 Drop of the ROP Study Drug|"ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.~REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours."
11369086|NCT00634972|BG001|Baseline|Placebo|placebo
11369087|NCT00634972|BG002|Baseline|Total|Total of all reporting groups
11369088|NCT00634972|FG000|Participant Flow|1 Drop of the ROP Study Drug|"ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.~REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours."
11369089|NCT00634972|FG001|Participant Flow|Placebo|placebo
11369090|NCT00634972|OG000|Outcome|1 Drop of the ROP Study Drug|"ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.~REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours."
11369091|NCT00634972|OG001|Outcome|Placebo|placebo
11369092|NCT00634972|EG000|Reported Event|1 Drop of the ROP Study Drug|"ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.~REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours."
11369093|NCT00634972|EG001|Reported Event|Placebo|placebo
11369094|NCT00633061|BG000|Baseline|A-Prosepctive Screeing for Asymptomatic DVT|"Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks~Enoxaparin: Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks."
11369095|NCT00633061|BG001|Baseline|B-Randomized Clinical Trail for Treatment|Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks
11369096|NCT00633061|BG002|Baseline|Total|Total of all reporting groups
11369097|NCT00633061|FG000|Participant Flow|A-Prosepctive Screening for Asymptomatic DVT|Patients </=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring tpa or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B
11369098|NCT00633061|FG001|Participant Flow|B-Randomized Clinical Trail for Treatment|Patients diagnosed with asymptomatic catheter-related DVT who are randomized to between enoxaparin or close observation for 6 weeks
11369099|NCT00633061|OG000|Outcome|A- Prospective Screening for Asymptomatic Catheter-related DVT|
11369100|NCT00633061|OG001|Outcome|B-Randomized Clinical Trail for Treatment|Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation or treatment with enoxaparin
11369101|NCT00633061|OG000|Outcome|A: Prospectvie Screening for Asymptomatic Catheter-related DVT|Patients </=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring thrombolysis or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B
11369102|NCT00633061|OG001|Outcome|B-randomized Treatment Trail|Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation or enoxaparin to treat asymptomatic DVT
11369103|NCT00633061|EG000|Reported Event|A-Prospective Screening for Asymptomatic Catheter-related DVT|Patients </=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring thrombolysis or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B
11369104|NCT00633061|EG001|Reported Event|B-Randomized Clinical Trial|Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation vs enoxaparin for 6 weeks
11369105|NCT00626444|BG000|Baseline|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
11369106|NCT00626444|FG000|Participant Flow|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
11369107|NCT00626444|OG000|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
11369108|NCT00626444|EG000|Reported Event|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
11369109|NCT00630292|BG000|Baseline|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
11369110|NCT00630292|FG000|Participant Flow|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
11369111|NCT00630292|OG000|Outcome|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
11369112|NCT00630292|EG000|Reported Event|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
11369113|NCT00634010|BG000|Baseline|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
11369114|NCT00634010|BG001|Baseline|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
11369115|NCT00634010|BG002|Baseline|Total|Total of all reporting groups
11369116|NCT00634010|FG000|Participant Flow|Morphine Capsule|Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.
11369117|NCT00634010|FG001|Participant Flow|Methadone Capsule|Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
11369118|NCT00634010|OG000|Outcome|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
11369119|NCT00634010|OG001|Outcome|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
11369120|NCT00634010|EG000|Reported Event|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
11369121|NCT00634010|EG001|Reported Event|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
11369122|NCT00630487|BG000|Baseline|Placebo|
11369123|NCT00630487|BG001|Baseline|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
11369124|NCT00630487|BG002|Baseline|Total|Total of all reporting groups
11369125|NCT00630487|FG000|Participant Flow|Placebo|
11377147|NCT03978091|EG001|Reported Event|AVYCAZ CI|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion once, then 0.32g dose per hour daily as a continuous infusion (CI) (7.5 g/day) for 7 days.
11337037|NCT03575975|EG000|Reported Event|Mobile-bearing Ankle Prosthesis User|"Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337038|NCT03575975|EG001|Reported Event|Fixed-bearing Ankle Prosthesis User|"Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.~Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints."
11337039|NCT03576066|BG000|Baseline|ABI-H0731 + SOC NUC|"Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11337040|NCT03576066|BG001|Baseline|Placebo + SOC NUC|"Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337041|NCT03576066|BG002|Baseline|Total|Total of all reporting groups
11337042|NCT03576066|FG000|Participant Flow|ABI-H0731 + SOC NUC|"Virologically suppressed participants will receive ABI-H0731 along with standard of care (SOC) nucleos(t)ide reverse transcriptase inhibitor (NUC) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11337043|NCT03576066|FG001|Participant Flow|Placebo + SOC NUC|"Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337044|NCT03576066|OG000|Outcome|HBeAg-positive Participants: ABI-H0731 + SOC NUC|"Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11337045|NCT03576066|OG001|Outcome|HBeAg-positive Participants: Placebo + SOC NUC|"Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337046|NCT03576066|OG002|Outcome|HBeAg-negative Participants: ABI-H0731 + SOC NUC|"Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11337047|NCT03576066|OG003|Outcome|HBeAg-negative Participants: Placebo + SOC NUC|"Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337048|NCT03576066|OG000|Outcome|ABI-H0731 + SOC NUC|"Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11337049|NCT03576066|OG001|Outcome|Placebo + SOC NUC|"Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337050|NCT03576066|EG000|Reported Event|ABI-H0731 + SOC NUC|"Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.~SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert."
11369126|NCT00630487|FG001|Participant Flow|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
11369127|NCT00630487|OG000|Outcome|Placebo|
11369128|NCT00630487|OG001|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
11369129|NCT00630487|EG000|Reported Event|Placebo|
11369130|NCT00630487|EG001|Reported Event|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
11369131|NCT00629850|BG000|Baseline|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
11369132|NCT00629850|BG001|Baseline|Control|This arm of the study will not receive the device.
11369133|NCT00629850|BG002|Baseline|Total|Total of all reporting groups
11369134|NCT00629850|FG000|Participant Flow|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
11369135|NCT00629850|FG001|Participant Flow|Control|This arm of the study will not receive the device.
11369136|NCT00629850|OG000|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
11369137|NCT00629850|OG001|Outcome|Control|This arm of the study will not receive the device.
11369138|NCT00629850|EG000|Reported Event|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
11369139|NCT00629850|EG001|Reported Event|Control|This arm of the study will not receive the device.
11369140|NCT00623974|BG000|Baseline|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369141|NCT00623974|BG001|Baseline|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369142|NCT00623974|BG002|Baseline|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369143|NCT00623974|BG003|Baseline|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369144|NCT00623974|BG004|Baseline|Total|Total of all reporting groups
11369145|NCT00623974|FG000|Participant Flow|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369146|NCT00623974|FG001|Participant Flow|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369147|NCT00623974|FG002|Participant Flow|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369148|NCT00623974|FG003|Participant Flow|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369149|NCT00623974|OG000|Outcome|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369150|NCT00623974|OG001|Outcome|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369151|NCT00623974|OG002|Outcome|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369152|NCT00623974|OG003|Outcome|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369153|NCT00623974|EG000|Reported Event|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369154|NCT00623974|EG001|Reported Event|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369155|NCT00623974|EG002|Reported Event|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369156|NCT00623974|EG003|Reported Event|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
11369157|NCT00624650|BG000|Baseline|Modified FACTT (Control)|
11369158|NCT00624650|BG001|Baseline|EVLW|
11369159|NCT00624650|BG002|Baseline|Total|Total of all reporting groups
11369160|NCT00624650|FG000|Participant Flow|Modified FACTT (Control)|
11369161|NCT00624650|FG001|Participant Flow|EVLW|
11369162|NCT00624650|OG000|Outcome|Modified FACTT (Control)|
11369163|NCT00624650|OG001|Outcome|EVLW|
11369164|NCT00624650|EG000|Reported Event|Modified FACTT (Control)|
11369165|NCT00624650|EG001|Reported Event|EVLW|
11369166|NCT00626561|BG000|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
11369167|NCT00626561|FG000|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
11369168|NCT00626561|OG000|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
11369169|NCT00626561|EG000|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
11369170|NCT00613730|BG000|Baseline|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
11377148|NCT03978091|EG002|Reported Event|ATM IV|2g dose of aztreonam (ATM) administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11377149|NCT03978091|EG003|Reported Event|ATM CI|2g of ATM administered intravenously as a 2-hour infusion once, then 0.33g dose administered intravenously per hour, daily as a continuous infusion (CI) (8 g/day) for 7 days.
11337051|NCT03576066|EG001|Reported Event|Placebo + SOC NUC|"Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.~SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert."
11337052|NCT03576118|BG000|Baseline|Deep Neuromuscular Block|"Deep neuromuscular relaxation and low pressure pneumoperitoneum~Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum"
11337053|NCT03576118|BG001|Baseline|Moderate Neuromuscular Block|"Moderate neuromuscular relaxation and standard pressure pneumoperitoneum~Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum"
11337054|NCT03576118|BG002|Baseline|Total|Total of all reporting groups
11337055|NCT03576118|FG000|Participant Flow|Deep Neuromuscular Block|"Deep neuromuscular relaxation and low pressure pneumoperitoneum~Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum"
11337056|NCT03576118|FG001|Participant Flow|Moderate Neuromuscular Block|"Moderate neuromuscular relaxation and standard pressure pneumoperitoneum~Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum"
11337057|NCT03576118|OG000|Outcome|Deep Neuromuscular Block|"Deep neuromuscular relaxation and low pressure pneumoperitoneum~Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum"
11337058|NCT03576118|OG001|Outcome|Moderate Neuromuscular Block|"Moderate neuromuscular relaxation and standard pressure pneumoperitoneum~Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum"
11337059|NCT03576118|EG000|Reported Event|Deep Neuromuscular Block|"Deep neuromuscular relaxation and low pressure pneumoperitoneum~Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum"
11337060|NCT03576118|EG001|Reported Event|Moderate Neuromuscular Block|"Moderate neuromuscular relaxation and standard pressure pneumoperitoneum~Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum"
11337061|NCT03576183|BG000|Baseline|VLA1701|"VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~The vaccine is administered orally in 2 doses about 1 week apart.~VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~Challenge Strain: LSN03-016011/A"
11337062|NCT03576183|BG001|Baseline|Placebo|"The buffer component of VLA1701 will be used as Placebo.~The vaccine is administered orally in 2 doses about 1 week apart.~Placebo: buffer component of VLA1701~Challenge Strain: LSN03-016011/A"
11337063|NCT03576183|BG002|Baseline|Total|Total of all reporting groups
11337064|NCT03576183|FG000|Participant Flow|VLA1701|"VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~The vaccine is administered orally in 2 doses about 1 week apart.~VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~Challenge Strain: LSN03-016011/A"
11337065|NCT03576183|FG001|Participant Flow|Placebo|"The buffer component of VLA1701 will be used as Placebo.~The vaccine is administered orally in 2 doses about 1 week apart.~Placebo: buffer component of VLA1701~Challenge Strain: LSN03-016011/A"
11337066|NCT03576183|OG000|Outcome|VLA1701|"VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~The vaccine is administered orally in 2 doses about 1 week apart.~VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~Challenge Strain: LSN03-016011/A"
11337067|NCT03576183|OG001|Outcome|Placebo|"The buffer component of VLA1701 will be used as Placebo.~The vaccine is administered orally in 2 doses about 1 week apart.~Placebo: buffer component of VLA1701~Challenge Strain: LSN03-016011/A"
11337068|NCT03576183|EG000|Reported Event|VLA1701|"VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~The vaccine is administered orally in 2 doses about 1 week apart.~VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)~Challenge Strain: LSN03-016011/A"
11337069|NCT03576183|EG001|Reported Event|Placebo|"The buffer component of VLA1701 will be used as Placebo.~The vaccine is administered orally in 2 doses about 1 week apart.~Placebo: buffer component of VLA1701~Challenge Strain: LSN03-016011/A"
11337070|NCT03576768|BG000|Baseline|Real cTBS to the vmPFC|"Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)"
11337071|NCT03576768|BG001|Baseline|Sham cTBS to the vmPFC|"Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337072|NCT03576768|BG002|Baseline|Real iTBS to the dlPFC|"Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)."
11341599|NCT03685344|BG002|Baseline|Dose Escalation: Loncastuximab Tesirine 150 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11369171|NCT00613730|FG000|Participant Flow|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
11369172|NCT00613730|OG000|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
11369173|NCT00613730|EG000|Reported Event|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
11369174|NCT00625586|BG000|Baseline|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
11369175|NCT00625586|FG000|Participant Flow|RAV12 Plus Gemcitabine|RAV12 monoclonal antibody plus gemcitabine
11369176|NCT00625586|OG000|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
11191696|NCT02133001|OG001|Outcome|Esketamine 84 mg|Participants self-administered 1 spray into each nostril (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) of Esketamine 84 milligram (mg) twice Weekly for 4 Weeks on Days 1, 4, 8, 11, 15, 18, 22, and Day 25 along with standard of care antidepressant treatment (determined by the treating physician based on clinical judgment) on Day 1 and continued for the duration of the double-blind treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to esketamine 56 mg was permitted if a participant was unable to tolerate the intranasal esketamine 84 mg. Participants continued to receive the reduced dose for the duration of the double-blind treatment phase.
11369177|NCT00625586|EG000|Reported Event|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
11369178|NCT00625703|BG000|Baseline|Linezolid: Pharmacokinetics|daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.
11369179|NCT00625703|FG000|Participant Flow|Linezolid: Pharmacokinetics|daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.
11369180|NCT00625703|OG000|Outcome|Linezolid: Pharmacokinetics|daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.
11369181|NCT00625703|EG000|Reported Event|Linezolid: Pharmacokinetics|daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.
11369182|NCT00625742|BG000|Baseline|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
11369183|NCT00625742|FG000|Participant Flow|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
11369184|NCT00625742|OG000|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
11369185|NCT00625742|EG000|Reported Event|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
11369186|NCT00619242|BG000|Baseline|Sorafenib|
11369187|NCT00619242|FG000|Participant Flow|Sorafenib|Sorafenib 400mg BID
11369188|NCT00619242|OG000|Outcome|Sorafenib|
11369189|NCT00619242|EG000|Reported Event|Sorafenib|
11369190|NCT00619151|BG000|Baseline|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
11369191|NCT00619151|BG001|Baseline|St.Jude Valve|St. Jude Medical Regent Valve
11369192|NCT00619151|BG002|Baseline|Total|Total of all reporting groups
11369193|NCT00619151|FG000|Participant Flow|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
11369194|NCT00619151|FG001|Participant Flow|St.Jude Valve|St. Jude Medical Regent Valve
11369195|NCT00619151|OG000|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
11369196|NCT00619151|OG001|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
11369197|NCT00619151|EG000|Reported Event|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
11369198|NCT00619151|EG001|Reported Event|St.Jude Valve|St. Jude Medical Regent Valve
11369199|NCT00622167|BG000|Baseline|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
11369200|NCT00622167|FG000|Participant Flow|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
11369201|NCT00622167|OG000|Outcome|Plaque Characteristics|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
11369202|NCT00622167|EG000|Reported Event|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
11369203|NCT00616577|BG000|Baseline|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369204|NCT00616577|BG001|Baseline|Group CA|"Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369205|NCT00616577|BG002|Baseline|Group LIA|"Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
11369206|NCT00616577|BG003|Baseline|Total|Total of all reporting groups
11369207|NCT00616577|FG000|Participant Flow|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369208|NCT00616577|FG001|Participant Flow|Group CA|"Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369209|NCT00616577|FG002|Participant Flow|Group LIA|"Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
11369210|NCT00616577|OG000|Outcome|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369211|NCT00616577|OG001|Outcome|Group CA|"Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369212|NCT00616577|OG002|Outcome|Group LIA|"Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
11369213|NCT00616577|EG000|Reported Event|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369214|NCT00616577|EG001|Reported Event|Group CA|"Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
11369215|NCT00616577|EG002|Reported Event|Group LIA|"Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
11369216|NCT00616759|BG000|Baseline|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
11369217|NCT00616759|BG001|Baseline|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
11369218|NCT00616759|BG002|Baseline|Total|Total of all reporting groups
11369219|NCT00616759|FG000|Participant Flow|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
11369220|NCT00616759|FG001|Participant Flow|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
11369221|NCT00616759|OG000|Outcome|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
11369222|NCT00616759|OG001|Outcome|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
11369223|NCT00616759|EG000|Reported Event|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
11369224|NCT00616759|EG001|Reported Event|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
11369225|NCT00616642|BG000|Baseline|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369226|NCT00616642|BG001|Baseline|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369227|NCT00616642|BG002|Baseline|Total|Total of all reporting groups
11369228|NCT00616642|FG000|Participant Flow|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369229|NCT00616642|FG001|Participant Flow|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369230|NCT00616642|OG000|Outcome|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369231|NCT00616642|OG001|Outcome|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369232|NCT00616642|EG000|Reported Event|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11191697|NCT02133001|EG000|Reported Event|Double Blind (Day 1-25): Placebo|Participants received intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) administered twice weekly for 4 Weeks on Days 1, 4, 8, 11, 15, 18, 22, and 25 along with standard of care antidepressant treatment determined by the treating physician based on clinical judgment on Day 1 and continued for the duration of the double-blind treatment phase.
11369233|NCT00616642|EG001|Reported Event|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
11369234|NCT00619515|BG000|Baseline|CyberKnife® Stereotactic Radiosurgery|"questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).~implanted fiducial-based imaging: Undergo fiducial placement imaging~stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days."
11369235|NCT00619515|FG000|Participant Flow|CyberKnife® Stereotactic Radiosurgery|"questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).~implanted fiducial-based imaging: Undergo fiducial placement imaging~stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days."
11369236|NCT00619515|OG000|Outcome|CyberKnife® Stereotactic Radiosurgery|"questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).~implanted fiducial-based imaging: Undergo fiducial placement imaging~stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days."
11369237|NCT00619515|EG000|Reported Event|CyberKnife® Stereotactic Radiosurgery|"questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).~implanted fiducial-based imaging: Undergo fiducial placement imaging~stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days."
11369238|NCT00616343|BG000|Baseline|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
11369239|NCT00616343|FG000|Participant Flow|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
11369240|NCT00616343|OG000|Outcome|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
11369241|NCT00616343|EG000|Reported Event|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
11369242|NCT00612677|BG000|Baseline|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
11369243|NCT00612677|FG000|Participant Flow|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
11369244|NCT00612677|OG000|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
11369245|NCT00612677|EG000|Reported Event|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
11369246|NCT00616603|BG000|Baseline|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
11369247|NCT00616603|BG001|Baseline|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
11369248|NCT00616603|BG002|Baseline|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
11369249|NCT00616603|BG003|Baseline|Total|Total of all reporting groups
11369250|NCT00616603|FG000|Participant Flow|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
11369251|NCT00616603|FG001|Participant Flow|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
11369252|NCT00616603|FG002|Participant Flow|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
11369253|NCT00616603|OG000|Outcome|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal sali
11369254|NCT00616603|OG001|Outcome|Group B|Subjects in Group B will have 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml of normal saline
11369255|NCT00616603|OG002|Outcome|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
11369256|NCT00616603|EG000|Reported Event|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
11369257|NCT00616603|EG001|Reported Event|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
11369258|NCT00616603|EG002|Reported Event|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
11369259|NCT00613886|BG000|Baseline|Subjective Comparisons Made for Patients - Before and After ex|"Programmable Shunt Insertion (Codman, Medtronic): Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied.~Assessments in physical therapy, occupational therapy, and speech therapy:"
11369260|NCT00613886|FG000|Participant Flow|Patients With External Lumbar Drain and Shunt Surg|All NPH patients shunted under this protocol have had a programmable valve inserted, either the Medtronic Strata valve, or the Codman-Hamim programmable valve. The valve pressure is set at the highest opening pressure at the time of implantation
11369261|NCT00613886|OG000|Outcome|Comparison for Patients of Lumbar Drain and Shunt Surgery|"Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery.~Device: Programmable Shunt Insertion Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Follow-up testing to be administered by trained physician assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, mini-mental status exam, 9-hole grooved pegboard, motor visual perception test (MVPT), modified rankin score (MRS) Programmable Shunt Insertion (Codman, Medtronic): Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter."
11369262|NCT00613886|OG000|Outcome|Comparison for Patients of Lumbar Drain and Shunt Surgery|Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery.
11369263|NCT00613886|EG000|Reported Event|Comparison for Patients of Lumbar Drain and Shunt Surgery|"Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery.~Device: Programmable Shunt Insertion (Codman Medtronic) Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Follow-up testing to be administered by trained physician assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, mini-mental status exam, 9-hole grooved pegboard, motor visual perception test (MVPT), modified rankin score (MRS) Programmable Shunt Insertion(Codman, Medtronic): Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter."
11369264|NCT00610467|BG000|Baseline|Disease Group|Patients with suspicious breast diseases
11369265|NCT00610467|BG001|Baseline|Control Group|Healthy volunteers for system testing
11369266|NCT00610467|BG002|Baseline|Total|Total of all reporting groups
11369267|NCT00610467|FG000|Participant Flow|Disease Group|Patients with suspicious breast diseases
11369268|NCT00610467|FG001|Participant Flow|Control Group|Healthy volunteers for system testing
11369269|NCT00610467|OG000|Outcome|Disease Group|Patients with suspicious breast diseases
11369270|NCT00610467|OG001|Outcome|Control Group|Healthy volunteers for system testing
11369271|NCT00610467|EG000|Reported Event|Disease Group|Patients with suspicious breast diseases.
11369272|NCT00610467|EG001|Reported Event|Control Group|Healthy volunteers for system testing
11369273|NCT00610558|BG000|Baseline|Arm1: Juvenile Myoclonic Epilepsy|Subject will are eligible for this group will participate the MRI imaging
11369274|NCT00610558|BG001|Baseline|Arm 2: Frontal Lobe Epilepsy|Subject will are eligible for this group will participate the MRI imaging
11369275|NCT00610558|BG002|Baseline|Arm 3: Normal Controls|Subject will are eligible for this group will participate the MRI imaging
11369276|NCT00610558|BG003|Baseline|Total|Total of all reporting groups
11369277|NCT00610558|FG000|Participant Flow|Arm 1: Juvenile Myoclonic Epilepsy|Subjects who are eligible for this group will participate MRI imaging
11369278|NCT00610558|FG001|Participant Flow|Arm 2: Frontal Lobe Epilepsy|Subjects who are eligible for this group will participate MRI imaging
11369279|NCT00610558|FG002|Participant Flow|Arm 3: Normal Cont|Subjects who are eligible for this group will participate MRI imaging
11369280|NCT00610558|OG000|Outcome|Arm 1: Juvenile Myoclonic Epilepsy|Subjects who are eligible to Juvenile Myoclonic Epilepsy will participate the imaging study
11369281|NCT00610558|OG001|Outcome|Arm 2: Frontal Lobe Epilepsy|Subjects who are eligible to Frontal Lobe Epilepsy will participate the imaging study
11369282|NCT00610558|OG002|Outcome|Arm 3: Normal Controls|Subjects who are eligible to the control group will participate the imaging study
11369283|NCT00610558|EG000|Reported Event|Arm 1: Juvenile Myoclonic Epilepsy|15 Subjects were monitored/assessed, but none observed
11369284|NCT00610558|EG001|Reported Event|Arm 2: Frontal Lobe Epilepsy|14 Subjects were monitored/assessed, but none observed
11341334|NCT03681405|OG000|Outcome|Group I eHealth Mindful Movement and Breathing (eMMB)|"Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.~Informational Intervention: Given information about mindful movement and breathing~Questionnaire Administration: Ancillary studies"
11341335|NCT03681405|OG001|Outcome|Group II Attention Control (AC)|"Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.~Questionnaire Administration: Ancillary studies~Telephone-Based Intervention: Receive caring attention phone call"
11341336|NCT03681405|EG000|Reported Event|Group I (eMMB)|"Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.~Informational Intervention: Given information about mindful movement and breathing~Questionnaire Administration: Ancillary studies"
11341337|NCT03681405|EG001|Reported Event|Group II (AC)|"Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.~Questionnaire Administration: Ancillary studies~Telephone-Based Intervention: Receive caring attention phone call"
11341600|NCT03685344|BG003|Baseline|Dose Expansion: Loncastuximab Tesirine|"The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma.~Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.~The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated."
11341601|NCT03685344|BG004|Baseline|Total|Total of all reporting groups
11341602|NCT03685344|FG000|Participant Flow|Dose Escalation: Loncastuximab Tesirine 90 μg/kg|Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341603|NCT03685344|FG001|Participant Flow|Dose Escalation: Loncastuximab Tesirine 120 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341604|NCT03685344|FG002|Participant Flow|Dose Escalation: Loncastuximab Tesirine 150 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341605|NCT03685344|FG003|Participant Flow|Dose Expansion: Loncastuximab Tesirine|"The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma.~Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.~The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated."
11341606|NCT03685344|OG000|Outcome|Dose Escalation: Loncastuximab Tesirine 90 μg/kg|Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341607|NCT03685344|OG001|Outcome|Dose Escalation: Loncastuximab Tesirine 120 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341608|NCT03685344|OG002|Outcome|Dose Escalation: Loncastuximab Tesirine 150 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341338|NCT03681808|BG000|Baseline|Biotrue|Biotrue ONEday for Astigmatism Soft Contact Lens®
11341339|NCT03681808|BG001|Baseline|Acuvue|1-Day Acuvue Moist for Astigmatism Contact Lens
11341340|NCT03681808|BG002|Baseline|Total|Total of all reporting groups
11341341|NCT03681808|FG000|Participant Flow|Biotrue|Biotrue ONEday for Astigmatism Soft Contact Lens®
11341342|NCT03681808|FG001|Participant Flow|Acuvue|1-Day Acuvue Moist for Astigmatism Contact Lens
11341343|NCT03681808|OG000|Outcome|Biotrue|Biotrue ONEday for Astigmatism Soft Contact Lens®
11341344|NCT03681808|OG001|Outcome|Acuvue|1-Day Acuvue Moist for Astigmatism Contact Lens
11341345|NCT03681808|EG000|Reported Event|Biotrue|Biotrue ONEday for Astigmatism Soft Contact Lens®
11341346|NCT03681808|EG001|Reported Event|Acuvue|1-Day Acuvue Moist for Astigmatism Contact Lens
11341347|NCT03681886|BG000|Baseline|All HMIOL Cohort|All subjects with attempted implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
11341348|NCT03681886|FG000|Participant Flow|All HMIOL Cohort|Implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
11341349|NCT03681886|OG000|Outcome|Cohort 1 - Day 1 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341350|NCT03681886|OG001|Outcome|Cohort 1 - Week 1 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341351|NCT03681886|OG002|Outcome|Cohort 1 - Month 1 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341352|NCT03681886|OG003|Outcome|Cohort 1 - Month 3 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341353|NCT03681886|OG004|Outcome|Cohort 1 - Month 6 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341354|NCT03681886|OG005|Outcome|Cohort 1 - Month 12 Post Primary Implantation|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341355|NCT03681886|OG000|Outcome|Cohort 2 - Day 0 Pre Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341356|NCT03681886|OG001|Outcome|Cohort 2 - Day 1 Post Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341357|NCT03681886|OG002|Outcome|Cohort 2 - Week 1 Post Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341358|NCT03681886|OG003|Outcome|Cohort 2 - Month 1 Post Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341359|NCT03681886|OG000|Outcome|Cohort 1 - Baseline (Day -90 to Day 0 Preoperative)|Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
11341360|NCT03681886|OG000|Outcome|Cohort 2 - Baseline (Day 0 Pre Optic Exchange),|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341361|NCT03681886|OG001|Outcome|Cohort 2 - Week 1 Post Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341362|NCT03681886|OG002|Outcome|Cohort 2 - Month 1 Post Optic Exchange|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341363|NCT03681886|OG000|Outcome|Cohort 2 - Baseline (Day 0 Pre Optic Exchange)|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341364|NCT03681886|OG000|Outcome|All HMIOL Cohort|Primary implantation with HMIOL
11341365|NCT03681886|OG000|Outcome|Cohort 2|Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
11341366|NCT03681886|EG000|Reported Event|Non-Ocular|All subjects with attempted HMIOL implantation (successful or aborted after contact with the eye)
11341367|NCT03681886|EG001|Reported Event|Ocular|All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye)
11341368|NCT03681951|BG000|Baseline|Part 1-GSK3145095 50 mg BID|Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID).
11341369|NCT03681951|BG001|Baseline|Part 1-GSK3145095 100 mg BID|Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID.
11341370|NCT03681951|BG002|Baseline|Part 1-GSK3145095 200 mg BID|Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID.
11341371|NCT03681951|BG003|Baseline|Part 1-GSK3145095 400 mg BID|Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID
11341372|NCT03681951|BG004|Baseline|Part 1-GSK3145095 800 mg BID|Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID.
11341373|NCT03681951|BG005|Baseline|Part 2- GSK3145095+ Pembrolizumab 200 mg|Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks.
11341374|NCT03681951|BG006|Baseline|Part 3- GSK3145095+ Pembrolizumab 200mg|Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks.
11341375|NCT03681951|BG007|Baseline|Part 4- GSK3145095+ Anticancer Agent|In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent
11341376|NCT03681951|BG008|Baseline|Total|Total of all reporting groups
11369285|NCT00610558|EG002|Reported Event|Arm 3: Normal Controls|14 Subjects were monitored/assessed, but none observed
11341377|NCT03681951|FG000|Participant Flow|Part 1-GSK3145095 50 mg BID|Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID).
11341378|NCT03681951|FG001|Participant Flow|Part 1-GSK3145095 100 mg BID|Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID.
11341379|NCT03681951|FG002|Participant Flow|Part 1-GSK3145095 200 mg BID|Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID.
11341380|NCT03681951|FG003|Participant Flow|Part 1-GSK3145095 400 mg BID|Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID
11341381|NCT03681951|FG004|Participant Flow|Part 1-GSK3145095 800 mg BID|Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID.
11341382|NCT03681951|FG005|Participant Flow|Part 2- GSK3145095+ Pembrolizumab 200 mg|Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks.
11341383|NCT03681951|FG006|Participant Flow|Part 3- GSK3145095+ Pembrolizumab 200 mg|Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks
11341384|NCT03681951|FG007|Participant Flow|Part 4- GSK3145095+ Anticancer Agent|In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent.
11341385|NCT03681951|OG000|Outcome|Part 1-GSK3145095 50 mg BID|Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID).
11341386|NCT03681951|OG001|Outcome|Part 1-GSK3145095 100 mg BID|Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID.
11341387|NCT03681951|OG002|Outcome|Part 1-GSK3145095 200 mg BID|Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID.
11341388|NCT03681951|OG003|Outcome|Part 1-GSK3145095 400 mg BID|Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID
11341389|NCT03681951|OG004|Outcome|Part 1-GSK3145095 800 mg BID|Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID.
11341390|NCT03681951|OG000|Outcome|Part 2-GSK3145095+ Pembrolizumab 200 mg|Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as IV infusion over 30 minutes for every 3 weeks.
11341391|NCT03681951|OG000|Outcome|Part 3 GSK3145095+ Pembrolizumab 200 mg|Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks.
11341392|NCT03681951|OG000|Outcome|Part 4 GSK3145095+ Anticancer Agent|In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent.
11341393|NCT03681951|OG000|Outcome|Part 4 GSK3145095 200 mg + Anticancer Agent|In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent.
11341394|NCT03681951|OG000|Outcome|Part 4 GSK3145095 + Anticancer Agent|In Part 4, participants were planned to receive GSK3145095 at recommended dose level determined during Part 2, in combination with anticancer agent.
11341395|NCT03681951|OG003|Outcome|1-GSK3145095 200 mg BID|Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID.
11341396|NCT03681951|OG002|Outcome|Part 1-GSK3145095 200 mg BID|Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID
11341397|NCT03681951|OG004|Outcome|Part 1-GSK3145095 800 mg BID|Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID
11341398|NCT03681951|OG000|Outcome|Part 1-GSK3145095 50 mg BID to 800 mg BID|Participants in this arm received 100 mg as 50 mg BID dose of GSK3142095. From study Day 2 participants were to receive 200 mg as dose of 100 mg BID, 400 mg as dose of 200 mg BID, 800 mg as dose of 400 mg BID, 1600 mg as dose of 800 mg BID orally.
11341399|NCT03681951|OG000|Outcome|Part 2- GSK3145095+ Pembrolizumab 200 mg|Part 2 was to be initiated after evaluation of safety and toxicity data of Part 1. Participants in this combination therapy arm were planned to receive GSK3145095 at one dose level below the highest dose shown to have an acceptable toxicity profile in at least 3 participants in Part 1 in combination with 200 mg pembrolizumab as Intravenous (IV) infusion over 30 minutes (min) for every 3 weeks.
11341400|NCT03681951|OG000|Outcome|Part 3 GSK3145095+ Pembrolizumab 200 mg|Part 3 was to be initiated after evaluation of safety and toxicity data of part 2. Participants in this combination therapy arm were planned to receive GSK3145095 at recommended dose level determined during Part 2, with 200 mg pembrolizumab as IV infusion for every 3 weeks
11341401|NCT03681951|EG000|Reported Event|Part 1-GSK3145095 50 mg BID|Participants received a single 50 milligram (mg) dose of GSK3145095 orally on Day 1. From study day 2, participants then received total daily dose of 100 mg GSK3145095 orally given as 50 mg twice a day (BID).
11369286|NCT00610532|BG000|Baseline|All Study Participants|All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
11369287|NCT00610532|FG000|Participant Flow|All Study Participants|All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
11369288|NCT00610532|OG000|Outcome|Intravenous Phenytoin Alone|intravenous phenytoin alone
11369289|NCT00610532|OG001|Outcome|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
11369290|NCT00610532|EG000|Reported Event|Intravenous Phenytoin Alone|intravenous phenytoin alone
11369291|NCT00610532|EG001|Reported Event|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
11369292|NCT00609765|BG000|Baseline|Chemotherapy|Prospective, single arm, Phase II
11369293|NCT00609765|FG000|Participant Flow|Chemotherapy|Prospective, single arm, Phase II
11369294|NCT00609765|OG000|Outcome|Chemotherapy|Prospective, single arm, Phase II
11369295|NCT00609765|EG000|Reported Event|Chemotherapy|Prospective, single arm, Phase II
11369296|NCT00608465|BG000|Baseline|All Patients|The study was never unblinded as enrollment was never completed.
11369297|NCT00608465|FG000|Participant Flow|All Patients|The study was never unblinded as enrollment was never completed.
11369298|NCT00608465|OG000|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
11369299|NCT00608465|EG000|Reported Event|All Patients|The study was never unblinded as enrollment was never completed.
11369300|NCT00608777|BG000|Baseline|Open Label Taclonex|
11369301|NCT00608777|FG000|Participant Flow|Open Label Taclonex|
11369302|NCT00608777|OG000|Outcome|Open Label Taclonex|
11369303|NCT00608777|EG000|Reported Event|Open Label|
11369304|NCT00601848|BG000|Baseline|Single Arm|"PDT~chemotherapy~porfimer sodium~immunohistochemistry staining method~laboratory biomarker analysis~spectroscopy~therapeutic conventional surgery"
11369305|NCT00601848|FG000|Participant Flow|Photodynamic Therapy|"PDT~chemotherapy~porfimer sodium~immunohistochemistry staining method~laboratory biomarker analysis~spectroscopy~therapeutic conventional surgery"
11369306|NCT00601848|OG000|Outcome|Single Arm|"PDT~chemotherapy~porfimer sodium~immunohistochemistry staining method~laboratory biomarker analysis~spectroscopy~therapeutic conventional surgery"
11369307|NCT00601848|EG000|Reported Event|Single Arm|"PDT~chemotherapy~porfimer sodium~immunohistochemistry staining method~laboratory biomarker analysis~spectroscopy~therapeutic conventional surgery"
11369308|NCT00607477|BG000|Baseline|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
11369309|NCT00607477|BG001|Baseline|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
11369310|NCT00607477|BG002|Baseline|Total|Total of all reporting groups
11369311|NCT00607477|FG000|Participant Flow|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
11369312|NCT00607477|FG001|Participant Flow|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
11369313|NCT00607477|OG000|Outcome|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
11369314|NCT00607477|OG001|Outcome|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
11369315|NCT00607477|EG000|Reported Event|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
11369316|NCT00607477|EG001|Reported Event|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
11369317|NCT00595920|BG000|Baseline|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
11369318|NCT00595920|FG000|Participant Flow|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
11369319|NCT00595920|OG000|Outcome|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
11369320|NCT00595920|EG000|Reported Event|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
11369321|NCT00596947|BG000|Baseline|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
11369322|NCT00596947|BG001|Baseline|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
11369323|NCT00596947|BG002|Baseline|Total|Total of all reporting groups
11369324|NCT00596947|FG000|Participant Flow|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
11337073|NCT03576768|BG003|Baseline|Sham iTBS to the dlPFC|"Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337074|NCT03576768|BG004|Baseline|Total|Total of all reporting groups
11337075|NCT03576768|FG000|Participant Flow|Real cTBS to the vmPFC|"Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)"
11337076|NCT03576768|FG001|Participant Flow|Sham cTBS to the vmPFC|"Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337077|NCT03576768|FG002|Participant Flow|Real iTBS to the dlPFC|"Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)."
11337078|NCT03576768|FG003|Participant Flow|Sham iTBS to the dlPFC|"Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337079|NCT03576768|OG000|Outcome|Real cTBS to the vmPFC|"Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)"
11337080|NCT03576768|OG001|Outcome|Sham cTBS to the vmPFC|"Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337081|NCT03576768|OG002|Outcome|Real iTBS to the dlPFC|"Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)."
11337082|NCT03576768|OG003|Outcome|Sham iTBS to the dlPFC|"Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337083|NCT03576768|EG000|Reported Event|Real cTBS to the vmPFC|"Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)"
11337084|NCT03576768|EG001|Reported Event|Sham cTBS to the vmPFC|"Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)~Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337085|NCT03576768|EG002|Reported Event|Real iTBS to the dlPFC|"Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)."
11341402|NCT03681951|EG001|Reported Event|Part 1-GSK3145095 100 mg BID|Participants were to receive a single 100 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 200 mg GSK3145095 given as 100 mg BID.
11341403|NCT03681951|EG002|Reported Event|Part 1-GSK3145095 200 mg BID|Participants were to receive a single 200 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 400 mg GSK3145095 given as 200 mg BID.
11341404|NCT03681951|EG003|Reported Event|Part 1-GSK3145095 400 mg BID|Participants were to receive a single 400 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 800 mg dose of GSK3145095 given as 400 mg BID
11341405|NCT03681951|EG004|Reported Event|Part 1-GSK3145095 800 mg BID|Participants were to receive a single 800 mg dose of GSK3145095 orally on Day 1. From study Day 2, participants were to receive 1600 mg dose of GSK3145095 given as 800 mg BID.
11341406|NCT03682107|BG000|Baseline|2 mg ANDV, 3 Dose Regimen|"2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341407|NCT03682107|BG001|Baseline|2 mg ANDV, 4 Dose Regimen|"2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341408|NCT03682107|BG002|Baseline|4 mg ANDV, 3 Dose Regimen|"4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341409|NCT03682107|BG003|Baseline|4 mg ANDV, 4 Dose Regimen|"4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341410|NCT03682107|BG004|Baseline|Placebo|"2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.~Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System"
11341411|NCT03682107|BG005|Baseline|Total|Total of all reporting groups
11341412|NCT03682107|FG000|Participant Flow|2 mg ANDV, 3 Dose Regimen|"2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341413|NCT03682107|FG001|Participant Flow|2 mg ANDV, 4 Dose Regimen|"2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341414|NCT03682107|FG002|Participant Flow|4 mg ANDV, 3 Dose Regimen|"4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11341415|NCT03682107|FG003|Participant Flow|4 mg ANDV, 4 Dose Regimen|"4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.~Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System."
11337086|NCT03576768|EG003|Reported Event|Sham iTBS to the dlPFC|"Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)~Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil."
11337087|NCT03577171|BG000|Baseline|ABI-H0731 + SOC ETV|"Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert."
11337088|NCT03577171|BG001|Baseline|Placebo + SOC ETV|"Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally."
11337089|NCT03577171|BG002|Baseline|Total|Total of all reporting groups
11337090|NCT03577171|FG000|Participant Flow|ABI-H0731 + SOC ETV|"Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert."
11337091|NCT03577171|FG001|Participant Flow|Placebo + SOC ETV|"Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally."
11337092|NCT03577171|OG000|Outcome|ABI-H0731 + SOC ETV|"Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert."
11337093|NCT03577171|OG001|Outcome|Placebo + SOC ETV|"Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally."
11337094|NCT03577171|EG000|Reported Event|ABI-H0731 + SOC ETV|"Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.~ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert."
11337095|NCT03577171|EG001|Reported Event|Placebo + SOC ETV|"Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.~SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.~Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally."
11337096|NCT03577275|BG000|Baseline|All Study Participants|All participants were randomized to receive all 4 interventions
11337097|NCT03577275|FG000|Participant Flow|All Study Participants|This was a 4 way crossover study in which all study participants received the following treatments in random order; NST-4016 2000mg: Supratherapeutic dose of NST-4016, NST-4016 600mg: Likely maximum therapeutic dose of NST-4016, Moxifloxacin 400mg: Active comparator with known effect on QT interval, Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects. There were 12 possible treatment sequences
11337098|NCT03577275|OG000|Outcome|Placebo Oral Capsule|"Single dose of placebo to match NST-4016~Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects"
11337099|NCT03577275|OG001|Outcome|Moxifloxacin 400mg|"Single 400mg dose of active comparator moxifloxacin (open label)~Moxifloxacin 400mg: Active comparator with known effect on QT interval"
11337100|NCT03577275|OG002|Outcome|NST-4016 600mg|"Likely therapeutic dose of NST-4016~NST-4016 600mg: Likely maximum therapeutic dose of NST-4016"
11337101|NCT03577275|OG003|Outcome|NST-4016 2000mg|"Supratherapeutic dose of NST-4016~NST-4016 2000mg: Supratherapeutic dose of NST-4016"
11337102|NCT03577275|OG000|Outcome|Placebo|Single dose of placebo to match NST-4016 Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects
11337103|NCT03577275|OG001|Outcome|Moxifloxacin 400mg|Single 400mg dose of active comparator moxifloxacin (open label) Moxifloxacin 400mg: Active comparator with known effect on QT interval
11337104|NCT03577275|OG002|Outcome|NST-4016 600mg|Likely therapeutic dose of NST-4016 NST-4016 600mg: Likely maximum therapeutic dose of NST-4016
11337105|NCT03577275|OG003|Outcome|NST-4016 2000mg|Supratherapeutic dose of NST-4016 NST-4016 2000mg: Supratherapeutic dose of NST-4016
11337106|NCT03577275|EG000|Reported Event|Placebo Oral Capsule|"Single dose of placebo to match NST-4016~Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects"
11337107|NCT03577275|EG001|Reported Event|Moxifloxacin 400mg|"Single 400mg dose of active comparator moxifloxacin (open label)~Moxifloxacin 400mg: Active comparator with known effect on QT interval"
11369325|NCT00596947|FG001|Participant Flow|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
11337108|NCT03577275|EG002|Reported Event|NST-4016 600mg|"Likely therapeutic dose of NST-4016~NST-4016 600mg: Likely maximum therapeutic dose of NST-4016"
11337109|NCT03577275|EG003|Reported Event|NST-4016 2000mg|"Supratherapeutic dose of NST-4016~NST-4016 2000mg: Supratherapeutic dose of NST-4016"
11337110|NCT03577730|BG000|Baseline|Experimental|"Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337111|NCT03577730|BG001|Baseline|Control|"Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337112|NCT03577730|BG002|Baseline|Total|Total of all reporting groups
11337113|NCT03577730|FG000|Participant Flow|Experimental|"Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337114|NCT03577730|FG001|Participant Flow|Control|"Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337115|NCT03577730|OG000|Outcome|Experimental|"Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337116|NCT03577730|OG001|Outcome|Control|"Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337117|NCT03577730|EG000|Reported Event|Experimental|"Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337118|NCT03577730|EG001|Reported Event|Control|"Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.~Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants."
11337119|NCT03578146|BG000|Baseline|Module 2 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
11337120|NCT03578146|BG001|Baseline|Module 2 (210 mg)|210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min)
11337121|NCT03578146|BG002|Baseline|Module 2 (420 mg)|420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min)
11337122|NCT03578146|BG003|Baseline|Module 2 (600 mg)|600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min)
11337123|NCT03578146|BG004|Baseline|Module 2 (720 mg Bolus + 240 mg Infusion)|720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)
11337124|NCT03578146|BG005|Baseline|Module 2 (800 mg Bolus + 960 mg Infusion)|800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min]
11337125|NCT03578146|BG006|Baseline|Total|Total of all reporting groups
11337126|NCT03578146|FG000|Participant Flow|Module 2 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
11337127|NCT03578146|FG001|Participant Flow|Module 2 (210 mg)|210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min)
11337128|NCT03578146|FG002|Participant Flow|Module 2 (420 mg)|420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min)
11337129|NCT03578146|FG003|Participant Flow|Module 2 (600 mg)|600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min)
11337130|NCT03578146|FG004|Participant Flow|Module 2 (720 mg Bolus + 240 mg Infusion)|720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)
11337131|NCT03578146|FG005|Participant Flow|Module 2 (800 mg Bolus + 960 mg Infusion)|800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min]
11337132|NCT03578146|OG000|Outcome|Module 2 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
11337133|NCT03578146|OG001|Outcome|Module 2 (210 mg)|210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min)
11337134|NCT03578146|OG002|Outcome|Module 2 (420 mg)|420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min)
11337135|NCT03578146|OG003|Outcome|Module 2 (600 mg)|600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min)
11337136|NCT03578146|OG004|Outcome|Module 2 (720 mg Bolus + 240 mg Infusion)|720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)
11369326|NCT00596947|OG000|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
11369327|NCT00596947|OG001|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
11369328|NCT00596947|EG000|Reported Event|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
11369329|NCT00596947|EG001|Reported Event|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
11369330|NCT00584012|BG000|Baseline|Dose Esclation|"Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.~Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2."
11369331|NCT00584012|FG000|Participant Flow|Dose Esclation|"Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.~Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2."
11369332|NCT00584012|OG000|Outcome|Dose Esclation|"Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.~Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2."
11369333|NCT00584012|EG000|Reported Event|Dose Esclation|"Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.~Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2."
11369334|NCT00599131|BG000|Baseline|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
11369335|NCT00599131|FG000|Participant Flow|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
11369336|NCT00599131|OG000|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
11369337|NCT00599131|EG000|Reported Event|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
11369338|NCT00597909|BG000|Baseline|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369339|NCT00597909|BG001|Baseline|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11191698|NCT02133001|EG001|Reported Event|Double Blind (Day 1-25): Esketamine 84 mg|Participants self-administered 1 spray into each nostril (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) of Esketamine 84 milligram (mg) twice Weekly for 4 Weeks on Days 1, 4, 8, 11, 15, 18, 22, and Day 25 along with standard of care antidepressant treatment determined by the treating physician based on clinical judgment on Day 1 and continued for the duration of the double-blind treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to esketamine 56 mg was permitted if a participant was unable to tolerate the intranasal esketamine 84 mg. Participants continued to receive the reduced dose for the duration of the double-blind treatment phase.
11369340|NCT00597909|BG002|Baseline|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369341|NCT00597909|BG003|Baseline|Total|Total of all reporting groups
11369342|NCT00597909|FG000|Participant Flow|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369343|NCT00597909|FG001|Participant Flow|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369344|NCT00597909|FG002|Participant Flow|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369345|NCT00597909|OG000|Outcome|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369346|NCT00597909|OG001|Outcome|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369347|NCT00597909|OG002|Outcome|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369348|NCT00597909|EG000|Reported Event|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369349|NCT00597909|EG001|Reported Event|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369350|NCT00597909|EG002|Reported Event|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
11369351|NCT00593320|BG000|Baseline|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
11369352|NCT00593320|BG001|Baseline|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
11369353|NCT00593320|BG002|Baseline|Total|Total of all reporting groups
11369354|NCT00593320|FG000|Participant Flow|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
11369355|NCT00593320|FG001|Participant Flow|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
11369356|NCT00593320|OG000|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
11369357|NCT00593320|OG001|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
11369358|NCT00593320|EG000|Reported Event|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
11369359|NCT00593320|EG001|Reported Event|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
11369360|NCT00589550|BG000|Baseline|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
11369361|NCT00589550|FG000|Participant Flow|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
11369362|NCT00589550|OG000|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
11377150|NCT03978091|EG004|Reported Event|AVYCAZ + ATM 1.5|2.5g dose of AVYCAZ administered intravenously as a 2-hour infusion, every 8 hours for 7 days, and a 1.5g dose of ATM administered intravenously as a 2-hour infusion, every 6 hours for 7 days.
11369363|NCT00589550|EG000|Reported Event|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
11369364|NCT00577772|BG000|Baseline|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
11369365|NCT00577772|BG001|Baseline|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
11369366|NCT00577772|BG002|Baseline|Total|Total of all reporting groups
11369367|NCT00577772|FG000|Participant Flow|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
11369368|NCT00577772|FG001|Participant Flow|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
11369369|NCT00577772|OG000|Outcome|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
11369370|NCT00577772|OG001|Outcome|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
11369371|NCT00577772|EG000|Reported Event|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
11369372|NCT00577772|EG001|Reported Event|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
11369373|NCT00592007|BG000|Baseline|Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
11369374|NCT00592007|FG000|Participant Flow|Fulvestrand and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
11191699|NCT02133001|EG002|Reported Event|Follow Up Phase (Day 26-81): Placebo|Participants who completed the double blind treatment phase were continued to follow-up phase for 81 days.
11191700|NCT02133001|EG003|Reported Event|Follow Up Phase (Day 26-81): Esketamine 84 mg|Participants who completed the double blind treatment phase were continued to follow-up phase for 81 days.
11191701|NCT02133066|BG000|Baseline|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
11337137|NCT03578146|OG005|Outcome|Module 2 (800 mg Bolus + 960 mg Infusion)|800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min]
11191702|NCT02133066|BG001|Baseline|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
11191703|NCT02133066|BG002|Baseline|Total|Total of all reporting groups
11337138|NCT03578146|EG000|Reported Event|Module 2 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
11337139|NCT03578146|EG001|Reported Event|Module 2 (210 mg)|210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min)
11337140|NCT03578146|EG002|Reported Event|Module 2 (420 mg)|420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min)
11337141|NCT03578146|EG003|Reported Event|Module 2 (600 mg)|600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min)
11337142|NCT03578146|EG004|Reported Event|Module 2 (720 mg Bolus + 240 mg Infusion)|720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)
11337143|NCT03578146|EG005|Reported Event|Module 2 (800 mg Bolus + 960 mg Infusion)|800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min]
11337144|NCT03578549|BG000|Baseline|Oximetry Testing of Healthy Teeth and Those Requiring Removal|"To assess the ability of pulse oximeter to assess the presence of pulse in teeth and to correlate pulse oximeter readings with conventional pulp testing measures including cold test, electrical pulp test, percussion and palpation testings, pulse oximeter will be used with a special holding frame, for 15-30 seconds.~Note: the reading will not affect clinical practice; it is simply to gather data to see if pulse oximetry can facilitate diagnostic practices in the future~Pulse Oximetry: Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional."
11337145|NCT03578549|FG000|Participant Flow|Oximetry Testing of Healthy Teeth and Those Requiring Removal|"To assess the ability of pulse oximeter to assess the presence of pulse in teeth and to correlate pulse oximeter readings with conventional pulp testing measures including cold test, electrical pulp test, percussion and palpation testings, pulse oximeter will be used with a special holding frame, for 15-30 seconds.~Note: the reading will not affect clinical practice; it is simply to gather data to see if pulse oximetry can facilitate diagnostic practices in the future~Pulse Oximetry: Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional."
11337146|NCT03578549|OG000|Outcome|Oximetry Testing of Healthy Teeth and Those Requiring Removal|"To assess the ability of pulse oximeter to assess the presence of pulse in teeth and to correlate pulse oximeter readings with conventional pulp testing measures including cold test, electrical pulp test, percussion and palpation testings, pulse oximeter will be used with a special holding frame, for 15-30 seconds.~Note: the reading will not affect clinical practice; it is simply to gather data to see if pulse oximetry can facilitate diagnostic practices in the future. Pulse Oximetry: Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured."
11337147|NCT03578549|EG000|Reported Event|Oximetry Testing of Healthy Teeth and Those Requiring Removal|"To assess the ability of pulse oximeter to assess the presence of pulse in teeth and to correlate pulse oximeter readings with conventional pulp testing measures including cold test, electrical pulp test, percussion and palpation testings, pulse oximeter will be used with a special holding frame, for 15-30 seconds.~Note: the reading will not affect clinical practice; it is simply to gather data to see if pulse oximetry can facilitate diagnostic practices in the future~Pulse Oximetry: Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional."
11337148|NCT03578926|BG000|Baseline|Overall Study|All subjects are randomized to 2-week cross-over study to compare fanfilcon A and senofilcon A.
11337149|NCT03578926|FG000|Participant Flow|Fanfilcon A Toric|"Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.~Contact Lens: fanfilcon A toric"
11337150|NCT03578926|FG001|Participant Flow|Senofilcon A Toric|"Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.~Contact Lens: senofilcon A toric"
11337151|NCT03578926|OG000|Outcome|Fanfilcon A|"Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.~contact lens: fanfilcon A"
11337152|NCT03578926|OG001|Outcome|Senofilcon A|"Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.~contact lens: senofilcon A"
11337153|NCT03578926|OG000|Outcome|Fanfilcon A - 2 Weeks|"Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.~fanfilcon A: contact lens"
11337154|NCT03578926|OG001|Outcome|Senofilcon A - 2 Weeks|"Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.~senofilcon A: contact lens"
11337155|NCT03578926|EG000|Reported Event|Fanfilcon A|"Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.~fanfilcon A toric lens: contact lens"
11189611|NCT02120781|EG000|Reported Event|Azficel-T (Autologous Fibroblasts)|"Azficel-T will be injected into the vocal fold(s) three times at two week intervals.~Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.~Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril."
11189612|NCT02120781|EG001|Reported Event|Control|"Sterile saline will be injected into the vocal fold(s) three times at two week intervals.~Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s)."
11189613|NCT02120794|BG000|Baseline|530G Insulin Pump|"Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.~530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year."
11369375|NCT00592007|OG000|Outcome|Arm A|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
11369376|NCT00592007|EG000|Reported Event|A: Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
11369377|NCT00595582|BG000|Baseline|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
11369378|NCT00595582|FG000|Participant Flow|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
11369379|NCT00595582|OG000|Outcome|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
11369380|NCT00595582|EG000|Reported Event|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
11369381|NCT00588146|BG000|Baseline|Entire Study Population|Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
11369382|NCT00588146|FG000|Participant Flow|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
11369383|NCT00588146|FG001|Participant Flow|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
11369384|NCT00588146|OG000|Outcome|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
11369385|NCT00588146|OG001|Outcome|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
11369386|NCT00588146|EG000|Reported Event|Pegylated Interferon Alpha-2b|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week
11369387|NCT00588146|EG001|Reported Event|Standard Care|Subjects received standard care for hereditary hemorrhagic telangiectasia.
11369388|NCT00586209|BG000|Baseline|L-glutamine|"L-glutamine group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~L-Glutamine: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)"
11369389|NCT00586209|BG001|Baseline|Placebo|"Maltodextrin group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~Placebo: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine"
11369390|NCT00586209|BG002|Baseline|Total|Total of all reporting groups
11369391|NCT00586209|FG000|Participant Flow|L-glutamine|"L-glutamine group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~L-Glutamine: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)"
11369392|NCT00586209|FG001|Participant Flow|Placebo|"Maltodextrin group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~Placebo: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine"
11369393|NCT00586209|OG000|Outcome|L-glutamine|"L-glutamine group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~L-Glutamine: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)"
11189614|NCT02120794|FG000|Participant Flow|530G Insulin Pump|"Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.~530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year."
11189615|NCT02120794|OG000|Outcome|530G Insulin Pump|"Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.~530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year."
11189616|NCT02120794|EG000|Reported Event|530G Insulin Pump|"Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.~530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year."
11189617|NCT02120833|BG000|Baseline|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
11189618|NCT02120833|BG001|Baseline|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
11189619|NCT02120833|BG002|Baseline|Total|Total of all reporting groups
11189620|NCT02120833|FG000|Participant Flow|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
10850000|NCT00299494|EG005|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Refractory|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
11189621|NCT02120833|FG001|Participant Flow|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
11189622|NCT02120833|OG000|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
11189623|NCT02120833|OG001|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
11189624|NCT02120833|EG000|Reported Event|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
11189625|NCT02120833|EG001|Reported Event|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
11189626|NCT02120898|BG000|Baseline|Generic Imiquimod Cream 2.5%|Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189627|NCT02120898|BG001|Baseline|Zyclara® (Imiquimod) Cream 2.5%|Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189628|NCT02120898|BG002|Baseline|Vehicle Cream|Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189629|NCT02120898|BG003|Baseline|Total|Total of all reporting groups
11337156|NCT03578926|EG001|Reported Event|Senofilcon A|"Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.~senofilcon A toric lens: contact lens"
11337157|NCT03579290|BG000|Baseline|CBT4CBT Program|"The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe~CBT4CBT program: The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use,~Coping with craving,~Substance refusal skills,~Seemingly irrelevant decisions,~Planning for emergencies, and~Problem-solving skills.~Staying Safe"
11337158|NCT03579290|FG000|Participant Flow|CBT4CBT Program|"The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe~CBT4CBT program: The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use,~Coping with craving,~Substance refusal skills,~Seemingly irrelevant decisions,~Planning for emergencies, and~Problem-solving skills.~Staying Safe"
11337159|NCT03579290|OG000|Outcome|CBT4CBT Program|"The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe~CBT4CBT program: The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use,~Coping with craving,~Substance refusal skills,~Seemingly irrelevant decisions,~Planning for emergencies, and~Problem-solving skills.~Staying Safe"
11337160|NCT03579290|EG000|Reported Event|CBT4CBT Program|"The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe~CBT4CBT program: The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:~Understanding and changing patterns of drug use,~Coping with craving,~Substance refusal skills,~Seemingly irrelevant decisions,~Planning for emergencies, and~Problem-solving skills.~Staying Safe"
11337161|NCT03579433|BG000|Baseline|Overall|First surgical eye randomly assigned to Acrysof® IQ Toric (IOL) and Optiwave Refractive Analysis (ORA) with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
11369394|NCT00586209|OG001|Outcome|Placebo|"Maltodextrin group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~Placebo: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine"
11369395|NCT00586209|EG000|Reported Event|L-glutamine|"L-glutamine group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~L-Glutamine: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)"
11369396|NCT00586209|EG001|Reported Event|Placebo|"Maltodextrin group will be given at the following dosage:~17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily~Placebo: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine"
11369397|NCT00590538|BG000|Baseline|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
11369398|NCT00590538|FG000|Participant Flow|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
11369399|NCT00590538|OG000|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
11369400|NCT00590538|EG000|Reported Event|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
11189630|NCT02120898|FG000|Participant Flow|Generic Imiquimod Cream 2.5%|Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11369401|NCT00583115|BG000|Baseline|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
11369402|NCT00583115|FG000|Participant Flow|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
11369403|NCT00583115|OG000|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
11369404|NCT00583115|EG000|Reported Event|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
11369405|NCT00582712|BG000|Baseline|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
11369406|NCT00582712|FG000|Participant Flow|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
11369407|NCT00582712|OG000|Outcome|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
11369408|NCT00582712|EG000|Reported Event|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
11369409|NCT00586716|BG000|Baseline|IVIG no Living Donor|Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
11369410|NCT00586716|BG001|Baseline|IVIG With Living Donor|Intravenous immune globulin for patients who have living donors with positive crossmatch results.
11369411|NCT00586716|BG002|Baseline|Total|Total of all reporting groups
11189631|NCT02120898|FG001|Participant Flow|Zyclara® (Imiquimod) Cream 2.5%|Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11369412|NCT00586716|FG000|Participant Flow|Group 1 Intravenous Immune Globulin no Living Donor|"Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
11369413|NCT00586716|FG001|Participant Flow|Group 2 Intravenous Immune Globulin With Living Donor|"Patients who have living donors with positive crossmatch results.~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
11369414|NCT00586716|OG000|Outcome|Intravenous Immune Globulin|Intravenous immune globulin for patients who have living donors with positive crossmatch results
11369415|NCT00586716|OG000|Outcome|Group 1 Intravenous Immune Globulin|"Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
11369416|NCT00586716|OG001|Outcome|Group 2 Intravenous Immune Globulin|"Intravenous immune globulin for patients who have living donors with positive crossmatch results.~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
11369417|NCT00586716|EG000|Reported Event|Group 1 Intravenous Immune Globulin|Group 1 with Intravenous immune globulin with no living donor
11369418|NCT00586716|EG001|Reported Event|Group 2 Intravenous Immune Globulin|Group 2 intravenous immune globulin WITH living donor
11377151|NCT03978091|EG005|Reported Event|AVYCAZ + ATM 2.0|2.5 g dose of AVYCAZ administered intravenously as a 2-hour infusion every 8 hours for 7 days, and a 2g dose of ATM as a 2-hour infusion every 6 hours for 7 days.
11369419|NCT00583466|BG000|Baseline|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
11369420|NCT00583466|FG000|Participant Flow|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
11369421|NCT00583466|OG000|Outcome|1 Normal Saline Arm|"Polypectomy with normal saline injected for submucosal cushion creation~Normal saline: Normal saline will be injected under the lesion to create submucosal cushion"
11369422|NCT00583466|OG001|Outcome|2 HPMC Arm|"Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion~HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion"
11369423|NCT00583466|OG002|Outcome|3 Blood Arm|"Polypectomy after injection of autologous blood~Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
11369424|NCT00583466|EG000|Reported Event|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
11369425|NCT00588471|BG000|Baseline|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
11369426|NCT00588471|BG001|Baseline|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
11369427|NCT00588471|BG002|Baseline|Total|Total of all reporting groups
11369428|NCT00588471|FG000|Participant Flow|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
11369429|NCT00588471|FG001|Participant Flow|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
11369430|NCT00588471|OG000|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
10850001|NCT00299546|BG000|Baseline|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
11369431|NCT00588471|OG001|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
11369432|NCT00588471|EG000|Reported Event|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
11369433|NCT00588471|EG001|Reported Event|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
11369434|NCT00587795|BG000|Baseline|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
11369435|NCT00587795|BG001|Baseline|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
11369436|NCT00587795|BG002|Baseline|Total|Total of all reporting groups
11369437|NCT00587795|FG000|Participant Flow|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
11369438|NCT00587795|FG001|Participant Flow|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
11369439|NCT00587795|OG000|Outcome|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
11369440|NCT00587795|OG001|Outcome|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
11369441|NCT00587795|EG000|Reported Event|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
11369442|NCT00587795|EG001|Reported Event|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
11369443|NCT00590135|BG000|Baseline|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
11369444|NCT00590135|FG000|Participant Flow|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
11369445|NCT00590135|OG000|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
11369446|NCT00590135|OG000|Outcome|AORTIC STENOSIS PATIENTS|"Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
11369447|NCT00590135|EG000|Reported Event|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
11369448|NCT00582036|BG000|Baseline|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
11369449|NCT00582036|BG001|Baseline|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
11369450|NCT00582036|BG002|Baseline|Total|Total of all reporting groups
11369451|NCT00582036|FG000|Participant Flow|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
11189632|NCT02120898|FG002|Participant Flow|Vehicle Cream|Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189633|NCT02120898|OG000|Outcome|Generic Imiquimod Cream 2.5%|Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11369452|NCT00582036|FG001|Participant Flow|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
11369453|NCT00582036|OG000|Outcome|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
11369454|NCT00582036|OG001|Outcome|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
11369455|NCT00582036|EG000|Reported Event|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
11369456|NCT00582036|EG001|Reported Event|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
11369457|NCT00585585|BG000|Baseline|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
11369458|NCT00585585|FG000|Participant Flow|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
11369459|NCT00585585|OG000|Outcome|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
11369460|NCT00585585|EG000|Reported Event|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
11369461|NCT00585221|BG000|Baseline|Group 1|
11369462|NCT00585221|FG000|Participant Flow|All Patients|All participants enrolled.
11369463|NCT00585221|OG000|Outcome|All Patients|All participants enrolled
11369464|NCT00585221|EG000|Reported Event|All Enrolled|All participants enrolled
11369465|NCT00581113|BG000|Baseline|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
11369466|NCT00581113|BG001|Baseline|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
11369467|NCT00581113|BG002|Baseline|Total|Total of all reporting groups
11369468|NCT00581113|FG000|Participant Flow|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
11369469|NCT00581113|FG001|Participant Flow|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
11369470|NCT00581113|OG000|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
11369471|NCT00581113|OG001|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
11189634|NCT02120898|OG001|Outcome|Zyclara® (Imiquimod) Cream 2.5%|Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189635|NCT02120898|OG002|Outcome|Vehicle Cream|Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189636|NCT02120898|EG000|Reported Event|Generic Imiquimod Cream 2.5%|Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11369472|NCT00581113|EG000|Reported Event|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
11369473|NCT00581113|EG001|Reported Event|Standard Whole Brain RT|Standard Whole Brain RT
11369474|NCT00579254|BG000|Baseline|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
11369475|NCT00579254|FG000|Participant Flow|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
11369476|NCT00579254|OG000|Outcome|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
11369477|NCT00579254|EG000|Reported Event|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
11369478|NCT00587223|BG000|Baseline|Apligraf/Control|Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
11369479|NCT00587223|FG000|Participant Flow|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
11369480|NCT00587223|OG000|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
11369481|NCT00587223|OG001|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
11369482|NCT00587223|OG001|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
11189637|NCT02120898|EG001|Reported Event|Zyclara® (Imiquimod) Cream 2.5%|Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11189638|NCT02120898|EG002|Reported Event|Vehicle Cream|Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
11369483|NCT00587223|OG001|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
11369484|NCT00587223|EG000|Reported Event|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
11369485|NCT00585611|BG000|Baseline|Atorvastatin|"Heart failure patients assigned to atorvastatin~Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months"
11369486|NCT00585611|BG001|Baseline|Arm 2|"Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months~placebo: placebo"
11369487|NCT00585611|BG002|Baseline|Total|Total of all reporting groups
11369488|NCT00585611|FG000|Participant Flow|Atorvastatin|"Heart failure patients assigned to atorvastatin~Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months"
11369489|NCT00585611|FG001|Participant Flow|Arm 2|"Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months~placebo: placebo"
11369490|NCT00585611|OG000|Outcome|Atorvastatin|"Heart failure patients assigned to atorvastatin~Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months"
11369491|NCT00585611|OG001|Outcome|Arm 2|"Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months~placebo: placebo"
11369492|NCT00585611|EG000|Reported Event|Atorvastatin|"Heart failure patients assigned to atorvastatin~Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months"
11369493|NCT00585611|EG001|Reported Event|Arm 2|"Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months~placebo: placebo"
11369494|NCT00572260|BG000|Baseline|Antimicrobial Prophylaxis Administration With Daptomycin|
11369495|NCT00572260|FG000|Participant Flow|Antimicrobial Prophylaxis Administration With Daptomycin|
11369496|NCT00572260|OG000|Outcome|Patients Undergoing Cardiac Surgery|Patients undergoing cardiac valve replacement and coronary artery bypass grafting
11369497|NCT00572260|EG000|Reported Event|Antimicrobial Prophylaxis Administration With Daptomycin|
11369498|NCT00571194|BG000|Baseline|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
11369499|NCT00571194|FG000|Participant Flow|Pravastatin|Study drug given and have levels done to measure pharmacokinetics.
11369500|NCT00571194|OG000|Outcome|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
11369501|NCT00571194|EG000|Reported Event|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
11369502|NCT00584935|BG000|Baseline|Rituximab|
11369503|NCT00584935|FG000|Participant Flow|Rituximab|
11369504|NCT00584935|OG000|Outcome|Rituximab|
11369505|NCT00584935|OG000|Outcome|Rituximab|"The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).~Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)."
11369506|NCT00584935|EG000|Reported Event|Rituximab|
11369507|NCT00577395|BG000|Baseline|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
11369508|NCT00577395|BG001|Baseline|Placebo Tablet Once a Month|Placebo tablet once a month, orally
11369509|NCT00577395|BG002|Baseline|Total|Total of all reporting groups
11369510|NCT00577395|FG000|Participant Flow|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
11369511|NCT00577395|FG001|Participant Flow|Placebo Tablet Once a Month|Placebo tablet once a month, orally
11369512|NCT00577395|OG000|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
11369513|NCT00577395|OG001|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
11369514|NCT00577395|EG000|Reported Event|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
11369515|NCT00577395|EG001|Reported Event|Placebo Tablet Once a Month|Placebo tablet once a month, orally
11369516|NCT00573391|BG000|Baseline|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
11369517|NCT00573391|BG001|Baseline|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
11369518|NCT00573391|BG002|Baseline|Total|Total of all reporting groups
11369519|NCT00573391|FG000|Participant Flow|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
11369520|NCT00573391|FG001|Participant Flow|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
11369521|NCT00573391|OG000|Outcome|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
11369522|NCT00573391|OG001|Outcome|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
11369523|NCT00573391|EG000|Reported Event|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
11369524|NCT00573391|EG001|Reported Event|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
11369525|NCT00570258|BG000|Baseline|Fulvestrant Plus Placebo|"Fulvestrant: 250 mg IM Q 4 weeks~Placebo: 150 mg PO QD~Fulvestrant: 250 mg IM Q 4 weeks~Placebo: Placebo 150 mg PO QD"
11369526|NCT00570258|BG001|Baseline|Fulvestrant Plus Erlotnib|"Fulvestrant: 250 mg IM Q 4 weeks~Erlotinib: 150 mg PO QD~Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks~erlotinib: 150 mg PO QD"
11369527|NCT00570258|BG002|Baseline|Total|Total of all reporting groups
11369528|NCT00570258|FG000|Participant Flow|Fulvestrant Plus Placebo|"Fulvestrant: 250 mg IM Q 4 weeks~Placebo: 150 mg PO QD~Fulvestrant: 250 mg IM Q 4 weeks~Placebo: Placebo 150 mg PO QD"
11369529|NCT00570258|FG001|Participant Flow|Fulvestrant Plus Erlotinib|"Fulvestrant: 250 mg IM Q 4 weeks~Erlotinib: 150 mg PO QD~Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks~erlotinib: 150 mg PO QD"
11369530|NCT00570258|OG000|Outcome|Fulvestrant Plus Placebo|Fulvestrant plus placebo: Fulvestrant will be given on day 1 by intramuscular (IM) injection into your buttock muscle(s) then every 28 days. In addition, placebo will be given as a pill, which will be taken by mouth once a day, about the same time of day every day, one hour before or two hours after a meal.
11369531|NCT00570258|OG001|Outcome|Fulvestrant Plus Erlotinib|Fulvestrant plus erlotinib: Fulvestrant will be given on day 1 by intramuscular (IM) injection into your buttock muscle(s) then every 28 days. In addition, erlotinib will be given as a pill, which will be taken by mouth once a day, about the same time of day every day, one hour before or two hours after a meal.
11369532|NCT00570258|OG000|Outcome|Fulvestrant Plus Placebo|"Fulvestrant: 250 mg IM Q 4 weeks~Placebo: 150 mg PO QD~Fulvestrant: 250 mg IM Q 4 weeks~Placebo: Placebo 150 mg PO QD"
11369533|NCT00570258|OG001|Outcome|Fulvestrant Plus Erlotinib|"Fulvestrant: 250 mg IM Q 4 weeks~Erlotinib: 150 mg PO QD~Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks~erlotinib: 150 mg PO QD"
11369534|NCT00570258|EG000|Reported Event|Fulvestrant Plus Placebo|"Fulvestrant: 250 mg IM Q 4 weeks~Placebo: 150 mg PO QD~Fulvestrant: 250 mg IM Q 4 weeks~Placebo: Placebo 150 mg PO QD"
11369535|NCT00570258|EG001|Reported Event|Fulvestrant Plus Erlotinib|"Fulvestrant: 250 mg IM Q 4 weeks~Erlotinib: 150 mg PO QD~Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks~erlotinib: 150 mg PO QD"
11369536|NCT00568802|BG000|Baseline|All Participants|Participants received hydroxyurea, or placebo to match hydroxyurea.
11369537|NCT00568802|FG000|Participant Flow|All Participants|Participants received hydroxyurea, or placebo to match hydroxyurea.
11369538|NCT00568802|OG000|Outcome|Hydroxyurea|Hydroxyurea
11369539|NCT00568802|OG001|Outcome|Placebo|Placebo to match hydroxyurea
11369540|NCT00568802|EG000|Reported Event|Hydroxyurea|Hydroxyurea
11369541|NCT00568802|EG001|Reported Event|Placebo|Placebo to match hydroxyurea
11369542|NCT00576524|BG000|Baseline|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
11369543|NCT00576524|BG001|Baseline|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
11369544|NCT00576524|BG002|Baseline|Total|Total of all reporting groups
11369545|NCT00576524|FG000|Participant Flow|ITD First, Sham Device Next|A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
11369546|NCT00576524|FG001|Participant Flow|Sham Device First, ITD Next|A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
11369547|NCT00576524|OG000|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, followed by ITD next after 7 days.
11369548|NCT00576524|OG001|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device after 7 days.
11369549|NCT00576524|OG000|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, follwed by ITD 7 days later.
11369550|NCT00576524|OG001|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device 7 days later.
11369551|NCT00576524|OG000|Outcome|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
11369552|NCT00576524|OG001|Outcome|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
11369553|NCT00576524|EG000|Reported Event|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
11369554|NCT00576524|EG001|Reported Event|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
11369555|NCT00568698|BG000|Baseline|All Participants|Participants received hydroxyurea, or placebo to match hydroxyurea.
11369556|NCT00568698|FG000|Participant Flow|All Participants|Participants received hydroxyurea, or placebo to match hydroxyurea.
11369557|NCT00568698|OG000|Outcome|Hydroxyurea|Hydroxyurea
11369558|NCT00568698|OG001|Outcome|Placebo|Placebo to match hydroxyurea
11369559|NCT00568698|EG000|Reported Event|Hydroxyurea|Hydroxyurea
11369560|NCT00568698|EG001|Reported Event|Placebo|Placebo to match hydroxyurea
11369561|NCT00574080|BG000|Baseline|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369562|NCT00574080|BG001|Baseline|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369563|NCT00574080|BG002|Baseline|Total|Total of all reporting groups
11369564|NCT00574080|FG000|Participant Flow|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369565|NCT00574080|FG001|Participant Flow|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369566|NCT00574080|OG000|Outcome|Arm A|
11369567|NCT00574080|OG001|Outcome|Arm B|
11369568|NCT00574080|EG000|Reported Event|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369569|NCT00574080|EG001|Reported Event|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
11369570|NCT00558558|BG000|Baseline|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
11369571|NCT00558558|FG000|Participant Flow|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
11369572|NCT00558558|OG000|Outcome|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
11369573|NCT00558558|EG000|Reported Event|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
11369574|NCT00577356|BG000|Baseline|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
11369575|NCT00577356|FG000|Participant Flow|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
11369576|NCT00577356|OG000|Outcome|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
11369577|NCT00577356|EG000|Reported Event|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
11369578|NCT00573937|BG000|Baseline|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
11369579|NCT00573937|BG001|Baseline|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
11369580|NCT00573937|BG002|Baseline|Total|Total of all reporting groups
11369581|NCT00573937|FG000|Participant Flow|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
11369582|NCT00573937|FG001|Participant Flow|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
11369583|NCT00573937|OG000|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
11369584|NCT00573937|OG001|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
11369585|NCT00573937|EG000|Reported Event|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
11369586|NCT00573937|EG001|Reported Event|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
11369587|NCT00577317|BG000|Baseline|Arm 1|"Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.~Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage~Quality-of-Life Assessment: Ancillary studies"
11369588|NCT00577317|BG001|Baseline|Arm II|"Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks~Management of Therapy Complications: Receive Flexitouch home maintenance therapy~Quality-of-Life Assessment: Ancillary studies"
11369589|NCT00577317|BG002|Baseline|Total|Total of all reporting groups
11369590|NCT00577317|FG000|Participant Flow|Arm 1|"Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.~Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage~Quality-of-Life Assessment: Ancillary studies"
11369591|NCT00577317|FG001|Participant Flow|Arm II|"Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks~Management of Therapy Complications: Receive Flexitouch home maintenance therapy~Quality-of-Life Assessment: Ancillary studies"
11369592|NCT00577317|OG000|Outcome|Arm 1|"Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.~Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage~Quality-of-Life Assessment: Ancillary studies"
11369593|NCT00577317|OG001|Outcome|Arm II|"Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks~Management of Therapy Complications: Receive Flexitouch home maintenance therapy~Quality-of-Life Assessment: Ancillary studies"
11369594|NCT00577317|EG000|Reported Event|Arm 1|"Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.~Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage~Quality-of-Life Assessment: Ancillary studies"
11369595|NCT00577317|EG001|Reported Event|Arm II|"Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks~Management of Therapy Complications: Receive Flexitouch home maintenance therapy~Quality-of-Life Assessment: Ancillary studies"
11369596|NCT00571922|BG000|Baseline|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
11369597|NCT00571922|BG001|Baseline|Placebo|placebo: matching placebo
11369598|NCT00571922|BG002|Baseline|Total|Total of all reporting groups
11369599|NCT00571922|FG000|Participant Flow|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
11369600|NCT00571922|FG001|Participant Flow|Placebo|placebo: matching placebo
11369601|NCT00571922|OG000|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
11369602|NCT00571922|OG001|Outcome|Placebo|placebo: matching placebo
11369603|NCT00571922|EG000|Reported Event|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
11369604|NCT00571922|EG001|Reported Event|Placebo|placebo: matching placebo
11369605|NCT00569868|BG000|Baseline|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
11369606|NCT00569868|FG000|Participant Flow|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
11369607|NCT00569868|OG000|Outcome|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
11369608|NCT00569868|EG000|Reported Event|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
11369609|NCT00573157|BG000|Baseline|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
10850002|NCT00299546|BG001|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
11369610|NCT00573157|BG001|Baseline|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11369611|NCT00573157|BG002|Baseline|Total|Total of all reporting groups
11369612|NCT00573157|FG000|Participant Flow|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11189639|NCT02120924|BG000|Baseline|Azelaic Acid, 15% Topical Gel|"Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189640|NCT02120924|BG001|Baseline|Finacea® (Azelaic Acid) Gel, 15%|"Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189641|NCT02120924|BG002|Baseline|Gel Vehicle|"Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189642|NCT02120924|BG003|Baseline|Total|Total of all reporting groups
11189643|NCT02120924|FG000|Participant Flow|Azelaic Acid, 15% Topical Gel|"Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189644|NCT02120924|FG001|Participant Flow|Finacea® (Azelaic Acid) Gel, 15% (Intendis)|"Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189645|NCT02120924|FG002|Participant Flow|Gel Vehicle|"Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11337162|NCT03579433|FG000|Participant Flow|All Participants|First surgical eye randomly assigned to Acrysof® IQ Toric IOL and Optiwave Refractive Analysis with VerifEye+ (ORA With VerifEye+) or Acrysof® IQ Toric IOL and Barrett Toric Calculator (Barrett Toric Calculator), with the second surgical eye (fellow eye) assigned to the alternative group.
11337163|NCT03579433|OG000|Outcome|ORA With VerifEye+|Acrysof® IQ Toric IOL and ORA with VerifEye+
11337164|NCT03579433|OG001|Outcome|Barrett Toric Calculator|Acrysof® IQ Toric IOL and Barrett Toric Calculator
11337165|NCT03579433|EG000|Reported Event|Pretreatment|All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye)
11337166|NCT03579433|EG001|Reported Event|ORA With VerifEye+ Study Eye|All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+
11337167|NCT03579433|EG002|Reported Event|Barrett Toric Calculator Study Eye|All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator
11337168|NCT03579433|EG003|Reported Event|Overall Systemic|All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)
11337169|NCT03579719|BG000|Baseline|Balovaptan + Itraconzole|Dosing in Period 1 was separated by at least a 7 day washout period before dosing started in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
11337170|NCT03579719|FG000|Participant Flow|Balovaptan + Itraconzole|Dosing in Period 1 was separated by at least a 7 day washout period before dosing started in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
11337171|NCT03579719|OG000|Outcome|Balovaptan + Itraconzole|Dosing in Period 1 was separated by at least a 7 day washout period before dosing started in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
11337172|NCT03579719|EG000|Reported Event|Balovaptan + Itraconzole|Dosing in Period 1 was separated by at least a 7 day washout period before dosing started in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
11337173|NCT03579940|BG000|Baseline|Cohort 1: Sequence 1: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan."
11337174|NCT03579940|BG001|Baseline|Cohort 1: Sequence 2: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan."
11337175|NCT03579940|BG002|Baseline|Cohort 1: Sequence 3: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo."
11337176|NCT03579940|BG003|Baseline|Cohort 2: Sequence 1: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11337177|NCT03579940|BG004|Baseline|Cohort 2: Sequence 2: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11189646|NCT02120924|OG000|Outcome|Azelaic Acid, 15% Topical Gel|"Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189647|NCT02120924|OG001|Outcome|Finacea® (Azelaic Acid) Gel, 15%|"Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189648|NCT02120924|OG002|Outcome|Gel Vehicle|"Placebo product (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11369613|NCT00573157|FG001|Participant Flow|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11189649|NCT02120924|OG002|Outcome|Gel Vehicle|"Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189650|NCT02120924|EG000|Reported Event|Azelaic Acid, 15% Topical Gel|"Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189651|NCT02120924|EG001|Reported Event|Finacea® (Azelaic Acid) Gel, 15%|"Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11189652|NCT02120924|EG002|Reported Event|Gel Vehicle|"Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)~Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site."
11369614|NCT00573157|OG000|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11369615|NCT00573157|OG001|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11369616|NCT00573157|EG000|Reported Event|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11189653|NCT02120950|BG000|Baseline|Aflibercept + Sham Photodynamic Therapy (PDT)|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
11191704|NCT02133066|FG000|Participant Flow|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
11369617|NCT00573157|EG001|Reported Event|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
11189654|NCT02120950|BG001|Baseline|Aflibercept + Active PDT|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
11189655|NCT02120950|BG002|Baseline|Total|Total of all reporting groups
11189656|NCT02120950|FG000|Participant Flow|Aflibercept + Sham Photodynamic Therapy (PDT)|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
11189657|NCT02120950|FG001|Participant Flow|Aflibercept + Active PDT|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
11189658|NCT02120950|FG002|Participant Flow|Aflibercept (Non-randomized)|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization
11189659|NCT02120950|OG000|Outcome|Aflibercept + Sham Photodynamic Therapy (PDT)|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
11189660|NCT02120950|OG001|Outcome|Aflibercept + Active PDT|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
11369618|NCT00570531|BG000|Baseline|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
11369619|NCT00570531|FG000|Participant Flow|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
11369620|NCT00570531|OG000|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
11189661|NCT02120950|EG000|Reported Event|Aflibercept + Sham PDT|Subjects received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period).At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
11189662|NCT02120950|EG001|Reported Event|Aflibercept + Active PDT|Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
11189663|NCT02120950|EG002|Reported Event|Aflibercept (Non-randomized)|Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization.
11369621|NCT00570531|EG000|Reported Event|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
11369622|NCT00566462|BG000|Baseline|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369623|NCT00566462|BG001|Baseline|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369624|NCT00566462|BG002|Baseline|Total|Total of all reporting groups
11369625|NCT00566462|FG000|Participant Flow|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369626|NCT00566462|FG001|Participant Flow|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369627|NCT00566462|OG000|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369628|NCT00566462|OG001|Outcome|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369629|NCT00566462|EG000|Reported Event|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369630|NCT00566462|EG001|Reported Event|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
11369631|NCT00561912|BG000|Baseline|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
11369632|NCT00561912|FG000|Participant Flow|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
11369633|NCT00561912|OG000|Outcome|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
11369634|NCT00561912|EG000|Reported Event|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
11369635|NCT00561795|BG000|Baseline|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369636|NCT00561795|BG001|Baseline|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369637|NCT00561795|BG002|Baseline|Total|Total of all reporting groups
11369638|NCT00561795|FG000|Participant Flow|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369639|NCT00561795|FG001|Participant Flow|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369640|NCT00561795|FG002|Participant Flow|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369641|NCT00561795|FG003|Participant Flow|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369642|NCT00561795|OG000|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369643|NCT00561795|OG001|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369644|NCT00561795|OG002|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369645|NCT00561795|OG003|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369646|NCT00561795|EG000|Reported Event|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
11369647|NCT00561795|EG001|Reported Event|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
11369648|NCT00564876|BG000|Baseline|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
11369649|NCT00564876|FG000|Participant Flow|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
11369650|NCT00564876|OG000|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
11369651|NCT00564876|EG000|Reported Event|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
11369652|NCT00558870|BG000|Baseline|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
11369653|NCT00558870|BG001|Baseline|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
11369654|NCT00558870|BG002|Baseline|Total|Total of all reporting groups
11369655|NCT00558870|FG000|Participant Flow|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
11369656|NCT00558870|FG001|Participant Flow|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
11369657|NCT00558870|OG000|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
11189664|NCT02121002|BG000|Baseline|Diclofenac Sodium Topical Gel, 1%|"Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Diclofenac Sodium Topical Gel, 1%: Opaque, white gel"
11189665|NCT02121002|BG001|Baseline|Voltaren Topical Gel, 1%|"Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Voltaren Topical Gel, 1%: Opaque, white gel"
11189666|NCT02121002|BG002|Baseline|Vehicle Diclofenac Sodium Topical Gel|"Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks~Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel"
11189667|NCT02121002|BG003|Baseline|Total|Total of all reporting groups
11369658|NCT00558870|OG001|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
11369659|NCT00558870|EG000|Reported Event|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
11369660|NCT00558870|EG001|Reported Event|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
11369661|NCT00559897|BG000|Baseline|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
11369662|NCT00559897|FG000|Participant Flow|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
11369663|NCT00559897|OG000|Outcome|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
11369664|NCT00559897|EG000|Reported Event|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
11377152|NCT03903640|BG000|Baseline|Optune + Ipilimumab + Nivolumab|"Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.~Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses~Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.~Treatment may continue for up to 1 year"
11189668|NCT02121002|FG000|Participant Flow|Diclofenac Sodium Topical Gel, 1%|"Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Diclofenac Sodium Topical Gel, 1%: Opaque, white gel"
11189669|NCT02121002|FG001|Participant Flow|Voltaren Topical Gel, 1%|"Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Voltaren Topical Gel, 1%: Opaque, white gel"
11189670|NCT02121002|FG002|Participant Flow|Vehicle Diclofenac Sodium Topical Gel|"Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks~Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel"
11377153|NCT03903640|FG000|Participant Flow|Optune + Ipilimumab + Nivolumab|"Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.~Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses~Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.~Treatment may continue for up to 1 year"
11189671|NCT02121002|OG000|Outcome|Diclofenac Sodium Topical Gel, 1%|"Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Diclofenac Sodium Topical Gel, 1%: Opaque, white gel"
11189672|NCT02121002|OG001|Outcome|Voltaren Topical Gel, 1%|"Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Voltaren Topical Gel, 1%: Opaque, white gel"
11189673|NCT02121002|OG002|Outcome|Vehicle Diclofenac Sodium Topical Gel|"Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks~Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel"
11189674|NCT02121002|EG000|Reported Event|Diclofenac Sodium Topical Gel, 1%|"Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Diclofenac Sodium Topical Gel, 1%: Opaque, white gel"
11189675|NCT02121002|EG001|Reported Event|Voltaren Topical Gel, 1%|"Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks~Voltaren Topical Gel, 1%: Opaque, white gel"
11189676|NCT02121002|EG002|Reported Event|Vehicle Diclofenac Sodium Topical Gel|"Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks~Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel"
11189677|NCT02121041|BG000|Baseline|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
11189678|NCT02121041|BG001|Baseline|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
11189679|NCT02121041|BG002|Baseline|Total|Total of all reporting groups
11189680|NCT02121041|FG000|Participant Flow|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
11189681|NCT02121041|FG001|Participant Flow|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
11189682|NCT02121041|OG000|Outcome|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
10850003|NCT00299546|BG002|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
10850004|NCT00299546|BG003|Baseline|Total|Total of all reporting groups
11189683|NCT02121041|OG001|Outcome|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
11369665|NCT00556400|BG000|Baseline|Lo-ovral|1 tablet of lo-ovral is administered twice a day
11369666|NCT00556400|BG001|Baseline|Sugar Pill|
11369667|NCT00556400|BG002|Baseline|Total|Total of all reporting groups
11369668|NCT00556400|FG000|Participant Flow|Lo-ovral|1 tablet of lo-ovral is administered twice a day
11369669|NCT00556400|FG001|Participant Flow|Sugar Pill|
11369670|NCT00556400|OG000|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
11369671|NCT00556400|OG001|Outcome|Sugar Pill|
11369672|NCT00556400|EG000|Reported Event|Sugar Pill|
11369673|NCT00556075|BG000|Baseline|Placebo|Placebo: 1 capsule daily for 4 months
11369674|NCT00556075|BG001|Baseline|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
11369675|NCT00556075|BG002|Baseline|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
11369676|NCT00556075|BG003|Baseline|Total|Total of all reporting groups
11369677|NCT00556075|FG000|Participant Flow|C Placebo|Placebo: 1 capsule daily for 4 months
11369678|NCT00556075|FG001|Participant Flow|A 25 mg|Proellex 25 mg: 1 capsule daily for 4 months
11369679|NCT00556075|FG002|Participant Flow|B 50 mg|Proellex 50 mg: 2 capsules daily for 4 months
11369680|NCT00556075|OG000|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
11369681|NCT00556075|OG001|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
11369682|NCT00556075|OG002|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
11369683|NCT00556075|OG000|Outcome|Placebo|Placebo: 1capsule daily for 4 months
11369684|NCT00556075|OG001|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
11369685|NCT00556075|OG002|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
11369686|NCT00556075|OG000|Outcome|Placebo|"Placebo~Placebo: 1 capsule daily for 4 months"
11369687|NCT00556075|EG000|Reported Event|Placebo|Placebo: 1 capsule daily for 4 months
11369688|NCT00556075|EG001|Reported Event|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
11369689|NCT00556075|EG002|Reported Event|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
11369690|NCT00556166|BG000|Baseline|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
11369691|NCT00556166|FG000|Participant Flow|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
11369692|NCT00556166|OG000|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
11369693|NCT00556166|EG000|Reported Event|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
11369694|NCT00521924|BG000|Baseline|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
11369695|NCT00521924|BG001|Baseline|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
11369696|NCT00521924|BG002|Baseline|Total|Total of all reporting groups
11369697|NCT00521924|FG000|Participant Flow|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
11369698|NCT00521924|FG001|Participant Flow|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
11369699|NCT00521924|OG000|Outcome|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
11369700|NCT00521924|OG001|Outcome|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
11369701|NCT00521924|EG000|Reported Event|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
11369702|NCT00521924|EG001|Reported Event|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
11369703|NCT00548886|BG000|Baseline|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
11369704|NCT00548886|FG000|Participant Flow|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
11369705|NCT00548886|OG000|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
11369706|NCT00548886|EG000|Reported Event|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
11369707|NCT00547456|BG000|Baseline|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
11369708|NCT00547456|FG000|Participant Flow|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
11369709|NCT00547456|OG000|Outcome|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
11369710|NCT00547456|EG000|Reported Event|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
11369711|NCT00539838|BG000|Baseline|Placebo|Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
11369712|NCT00539838|BG001|Baseline|Ocrelizumab 400 mg|Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
11369713|NCT00539838|BG002|Baseline|Ocrelizumab 1000 mg|Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
11369714|NCT00539838|BG003|Baseline|Total|Total of all reporting groups
11369715|NCT00539838|FG000|Participant Flow|Ocrelizumab 1000 mg|Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
11369716|NCT00539838|FG001|Participant Flow|Ocrelizumab 400 mg|Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
11369717|NCT00539838|FG002|Participant Flow|Placebo|Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
11369718|NCT00539838|OG000|Outcome|Placebo|Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
11369719|NCT00539838|OG001|Outcome|Ocrelizumab 400 mg|Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
11369720|NCT00539838|OG002|Outcome|Ocrelizumab 1000 mg|Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
11369721|NCT00539838|OG000|Outcome|Ocrelizumab 1000 mg|Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
11369722|NCT00539838|OG002|Outcome|Placebo|Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
11369723|NCT00539838|EG000|Reported Event|Placebo|Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
11369724|NCT00539838|EG001|Reported Event|Ocrelizumab 400 mg|Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
11369725|NCT00539838|EG002|Reported Event|Ocrelizumab 1000 mg|Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
11369726|NCT00549328|BG000|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
11369727|NCT00549328|FG000|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
11369728|NCT00549328|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
11369729|NCT00549328|EG000|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
11369730|NCT00548327|BG000|Baseline|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369731|NCT00548327|BG001|Baseline|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369732|NCT00548327|BG002|Baseline|Total|Total of all reporting groups
11369733|NCT00548327|FG000|Participant Flow|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369734|NCT00548327|FG001|Participant Flow|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369735|NCT00548327|OG000|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369736|NCT00548327|OG001|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
11369737|NCT00548327|OG000|Outcome|Healthy Participants|
11369738|NCT00548327|OG001|Outcome|Patients With Schizophrenia|
11369739|NCT00548327|OG000|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
11337178|NCT03579940|BG005|Baseline|Cohort 2: Sequence 3: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart)."
11337179|NCT03579940|BG006|Baseline|Cohort 2: Sequence 4: Japanese|"Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.~Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11337180|NCT03579940|BG007|Baseline|Cohort 3: Sequence 1: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan."
11337181|NCT03579940|BG008|Baseline|Cohort 3: Sequence 2: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan."
11337182|NCT03579940|BG009|Baseline|Cohort 3: Sequence 3: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo."
11337183|NCT03579940|BG010|Baseline|Cohort 3: Sequence 4: Caucasian|"Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan ."
11337184|NCT03579940|BG011|Baseline|Total|Total of all reporting groups
11337185|NCT03579940|FG000|Participant Flow|Cohort 1: Sequence 1: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan."
11337186|NCT03579940|FG001|Participant Flow|Cohort 1: Sequence 2: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan."
11337187|NCT03579940|FG002|Participant Flow|Cohort 1: Sequence 3: Japanese|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo."
11337188|NCT03579940|FG003|Participant Flow|Cohort 2: Sequence 1: Japanese|"Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11337189|NCT03579940|FG004|Participant Flow|Cohort 2: Sequence 2: Japanese|"Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11337190|NCT03579940|FG005|Participant Flow|Cohort 2: Sequence 3: Japanese|"Participants received single oral doses of Lasmiditan and repeated oral doses of placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart)."
11337191|NCT03579940|FG006|Participant Flow|Cohort 2: Sequence 4: Japanese|"Participants received single, repeated oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.~Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart)."
11337192|NCT03579940|FG007|Participant Flow|Cohort 3: Sequence 1: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan."
11337193|NCT03579940|FG008|Participant Flow|Cohort 3: Sequence 2: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan."
11337194|NCT03579940|FG009|Participant Flow|Cohort 3: Sequence 3: Caucasian|"Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo."
11337195|NCT03579940|FG010|Participant Flow|Cohort 3: Sequence 4: Caucasian|"Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.~Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan ."
11337196|NCT03579940|OG000|Outcome|Placebo: Japanese|Participants received single oral dose of placebo on day 1.
11337197|NCT03579940|OG001|Outcome|Placebo: Caucasian|Participants received single oral dose of placebo on day 1.
11337198|NCT03579940|OG002|Outcome|2 x Placebo: Japanese|Participants received 2 x Placebo (2 single oral doses administered 2 hours apart) on day 1.
11337199|NCT03579940|OG003|Outcome|50 mg Lasmiditan: Japanese|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337200|NCT03579940|OG004|Outcome|50 mg Lasmiditan: Caucasian|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337201|NCT03579940|OG005|Outcome|100 mg Lasmiditan: Japanese|Participants received single oral dose of 100 mg lasmiditan on day 1.
11337202|NCT03579940|OG006|Outcome|100 mg Lasmiditan: Caucasian|Participants received single oral dose of 100 mg lasmiditan on day 1.
11337203|NCT03579940|OG007|Outcome|200 mg Lasmiditan: Japanese|Participants received single oral dose of 200 mg lasmiditan on day 1
11337204|NCT03579940|OG008|Outcome|200 mg Lasmiditan: Caucasian|Participants received single oral dose of 200 mg lasmiditan on day 1.
11337205|NCT03579940|OG009|Outcome|400 mg Lasmiditan: Japanese|Participants received single oral dose of 400 mg lasmiditan on day 1.
11337206|NCT03579940|OG010|Outcome|2 X 200 mg Lasmiditan: Japanese|Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
11337207|NCT03579940|OG000|Outcome|50 mg Lasmiditan: Japanese|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337208|NCT03579940|OG001|Outcome|50 mg Lasmiditan: Caucasian|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337209|NCT03579940|OG002|Outcome|100 mg Lasmiditan: Japanese|Participants received single oral dose of 100 mg lasmiditan on day 1.
11369740|NCT00548327|EG000|Reported Event|Atomoxetine-Patient|
11369741|NCT00548327|EG001|Reported Event|Placebo-Patient|
11369742|NCT00548327|EG002|Reported Event|Atomoxetine-Healthy Volunteer|
11369743|NCT00548327|EG003|Reported Event|Placebo-Healthy Volunteer|
11369744|NCT00542542|BG000|Baseline|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
11369745|NCT00542542|BG001|Baseline|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
11369746|NCT00542542|BG002|Baseline|Total|Total of all reporting groups
11369747|NCT00542542|FG000|Participant Flow|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
11369748|NCT00542542|FG001|Participant Flow|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
11369749|NCT00542542|OG000|Outcome|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
11369750|NCT00542542|OG001|Outcome|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
11369751|NCT00542542|EG000|Reported Event|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
11369752|NCT00542542|EG001|Reported Event|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
11369753|NCT00545506|BG000|Baseline|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
11369754|NCT00545506|BG001|Baseline|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
11189684|NCT02121041|EG000|Reported Event|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
11369755|NCT00545506|BG002|Baseline|Total|Total of all reporting groups
11369756|NCT00545506|FG000|Participant Flow|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
11369757|NCT00545506|FG001|Participant Flow|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
11369758|NCT00545506|OG000|Outcome|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
11369759|NCT00545506|OG001|Outcome|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
11369760|NCT00545506|EG000|Reported Event|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
11369761|NCT00545506|EG001|Reported Event|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
11369762|NCT00547300|BG000|Baseline|Nebivolol|Nebivolol 5 mg, 10 mg or 20 mg
11369763|NCT00547300|BG001|Baseline|Metoprolol Extended-Release (ER)|Metoprolol ER 50 mg, 100 mg or 200 mg
11369764|NCT00547300|BG002|Baseline|Total|Total of all reporting groups
11369765|NCT00547300|FG000|Participant Flow|Nebivolol|Nebivolol 5 mg, 10 mg or 20 mg
11369766|NCT00547300|FG001|Participant Flow|Metoprolol Extended-Release (ER)|Metoprolol ER 50 mg, 100 mg or 200 mg
11369767|NCT00547300|OG000|Outcome|Nebivolol|Nebivolol 5 mg, 10 mg or 20 mg
11369768|NCT00547300|OG001|Outcome|Metoprolol Extended-Release (ER)|Metoprolol ER 50 mg, 100 mg or 200 mg
11369769|NCT00547300|EG000|Reported Event|Nebivolol|Nebivolol 5 mg, 10 mg or 20 mg
11369770|NCT00547300|EG001|Reported Event|Metoprolol Extended-Release (ER)|Metoprolol ER 50 mg, 100 mg or 200 mg
11369771|NCT00539617|BG000|Baseline|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
11369772|NCT00539617|FG000|Participant Flow|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
11337210|NCT03579940|OG003|Outcome|100 mg Lasmiditan: Caucasian|Participants received single oral dose of 100 mg lasmiditan on day 1.
11337211|NCT03579940|OG004|Outcome|200 mg Lasmiditan: Japanese|Participants received single oral dose of 200 mg lasmiditan on day 1.
11337212|NCT03579940|OG005|Outcome|200 mg Lasmiditan: Caucasian|Participants received single oral dose of 200 mg lasmiditan on day 1.
11337213|NCT03579940|OG006|Outcome|400 mg Lasmiditan: Japanese|Participants received single oral dose of 400 mg lasmiditan on day 1.
11337214|NCT03579940|OG007|Outcome|2 X 200 mg Lasmiditan: Japanese|Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
11337215|NCT03579940|EG000|Reported Event|Placebo: Japanese|Participants received single oral dose of placebo on day 1.
11337216|NCT03579940|EG001|Reported Event|Placebo: Caucasian|Participants received single oral dose of placebo on day 1.
11337217|NCT03579940|EG002|Reported Event|2 x Placebo: Japanese|Participants received 2 X Placebo (2 single oral doses administered 2 hours apart) on day 1.
11337218|NCT03579940|EG003|Reported Event|50 mg Lasmiditan: Japanese|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337219|NCT03579940|EG004|Reported Event|50 mg Lasmiditan: Caucasian|Participants received single oral dose of 50 mg lasmiditan on day 1.
11337220|NCT03579940|EG005|Reported Event|100 mg Lasmiditan: Japanese|Participants received single oral dose of 100 mg lasmiditan on day 1.
11337221|NCT03579940|EG006|Reported Event|100 mg Lasmiditan: Caucasian|Participants received single oral dose of 100 mg lasmiditan on day 1.
11337222|NCT03579940|EG007|Reported Event|200 mg Lasmiditan: Japanese|Participants received single oral dose of 200 mg lasmiditan on day 1.
11337223|NCT03579940|EG008|Reported Event|200 mg Lasmiditan: Caucasian|Participants received single oral dose of 200 mg lasmiditan on day 1.
11337224|NCT03579940|EG009|Reported Event|400 mg Lasmiditan: Japanese|Participants received single oral dose of 400 mg lasmiditan on day 1.
11337225|NCT03579940|EG010|Reported Event|2 x 200 mg Lasmiditan: Japanese|Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
11337226|NCT03580343|BG000|Baseline|Tofacitinib|single arm- tofacitinib 11mg daily
11337227|NCT03580343|FG000|Participant Flow|Tofacitinib Treatment|tofacitinib: tofacitinib extended release, 11mg, daily, oral
11337228|NCT03580343|OG000|Outcome|Tofacitinib Treatment|tofacitinib: tofacitinib extended release, 11mg, daily, oral
11337229|NCT03580343|EG000|Reported Event|Tofacitinib Treatment|tofacitinib: tofacitinib extended release, 11mg, daily, oral
11337230|NCT03581084|BG000|Baseline|N-acetylcysteine|"This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or mucus plugging. Initial study procedures will include lung function measurements, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs.~N-acetylcysteine: Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart."
11337231|NCT03581084|FG000|Participant Flow|N-acetylcysteine|"This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or mucus plugging. Initial study procedures will include lung function measurements, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs.~N-acetylcysteine: Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart."
11337232|NCT03581084|OG000|Outcome|N-acetylcysteine|"This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or mucus plugging. Initial study procedures will include lung function measurements, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs.~N-acetylcysteine: Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart."
11337233|NCT03581084|EG000|Reported Event|N-acetylcysteine|"This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or mucus plugging. Initial study procedures will include lung function measurements, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs.~N-acetylcysteine: Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart."
11337234|NCT03581097|BG000|Baseline|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of IVRA"
11369773|NCT00539617|OG000|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
11369774|NCT00539617|EG000|Reported Event|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
11369775|NCT00546455|BG000|Baseline|A- Fenretinide|"Subjects in this cohort will be given Fenretinide~Fenretinide: 200 mg/day"
11369776|NCT00546455|BG001|Baseline|B-Placebo|"Subjects in this cohort will be given placebo.~Placebo: 2 capsules/day"
11369777|NCT00546455|BG002|Baseline|Total|Total of all reporting groups
11369778|NCT00546455|FG000|Participant Flow|A- Fenretinide|"Subjects in this cohort will be given Fenretinide~Fenretinide: 200 mg/day"
11369779|NCT00546455|FG001|Participant Flow|B-Placebo|"Subjects in this cohort will be given placebo.~Placebo: 2 capsules/day"
11369780|NCT00546455|OG000|Outcome|A- Fenretinide|"Subjects in this cohort will be given Fenretinide~Fenretinide: 200 mg/day"
11369781|NCT00546455|OG001|Outcome|B-Placebo|"Subjects in this cohort will be given placebo.~Placebo: 2 capsules/day"
11369782|NCT00546455|EG000|Reported Event|A- Fenretinide|"Subjects in this cohort will be given Fenretinide~Fenretinide: 200 mg/day"
11369783|NCT00546455|EG001|Reported Event|B-Placebo|"Subjects in this cohort will be given placebo.~Placebo: 2 capsules/day"
11369784|NCT00538980|BG000|Baseline|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
11369785|NCT00538980|FG000|Participant Flow|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
11369786|NCT00538980|OG000|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
11369787|NCT00538980|EG000|Reported Event|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
11369788|NCT00540969|BG000|Baseline|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
11369789|NCT00540969|BG001|Baseline|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
11369790|NCT00540969|BG002|Baseline|Total|Total of all reporting groups
11189685|NCT02121041|EG001|Reported Event|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
11369791|NCT00540969|FG000|Participant Flow|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
11369792|NCT00540969|FG001|Participant Flow|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
11369793|NCT00540969|OG000|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
11369794|NCT00540969|OG001|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
11369795|NCT00540969|EG000|Reported Event|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
11369796|NCT00540969|EG001|Reported Event|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
11369797|NCT00535262|BG000|Baseline|Open EmSam|8-week open-label treatment with EmSam
11369798|NCT00535262|FG000|Participant Flow|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
11369799|NCT00535262|OG000|Outcome|EmSam|"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
11369800|NCT00535262|EG000|Reported Event|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
11369801|NCT00529464|BG000|Baseline|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
11337235|NCT03581097|BG001|Baseline|Control Group|Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
11337236|NCT03581097|BG002|Baseline|Total|Total of all reporting groups
11337237|NCT03581097|FG000|Participant Flow|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of IVRA"
11337238|NCT03581097|FG001|Participant Flow|Control Group|Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
11337239|NCT03581097|OG000|Outcome|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of Intra-Venous regional Anesthesia (IVRA)"
11337240|NCT03581097|OG001|Outcome|Control Group|Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
11337241|NCT03581097|OG000|Outcome|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of IVRA"
11337242|NCT03581097|OG000|Outcome|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of Intra-Venous Regional Anesthesia (IVRA)"
11337243|NCT03581097|EG000|Reported Event|Video Group|"Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia~Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the OR and the performance of IVRA"
11337244|NCT03581097|EG001|Reported Event|Control Group|Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
11369802|NCT00529464|BG001|Baseline|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
11369803|NCT00529464|BG002|Baseline|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
11369804|NCT00529464|BG003|Baseline|Total|Total of all reporting groups
11369805|NCT00529464|FG000|Participant Flow|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
11369806|NCT00529464|FG001|Participant Flow|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
11369807|NCT00529464|FG002|Participant Flow|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
11369808|NCT00529464|OG000|Outcome|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
11369809|NCT00529464|OG001|Outcome|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
11369810|NCT00529464|OG002|Outcome|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
11369811|NCT00529464|EG000|Reported Event|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
11369812|NCT00529464|EG001|Reported Event|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
11369813|NCT00529464|EG002|Reported Event|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
11369814|NCT00537199|BG000|Baseline|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
11369815|NCT00537199|FG000|Participant Flow|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
11369816|NCT00537199|OG000|Outcome|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
11369817|NCT00537199|EG000|Reported Event|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
11369818|NCT00537446|BG000|Baseline|High Level and Low Level Ventilation|All participants
11369819|NCT00537446|FG000|Participant Flow|High Level and Low Level Ventilation|All participants are listed as one group, as the breakdown per Arm/Group is not available (PI no longer has raw data on file).
11369820|NCT00537446|OG000|Outcome|High-level Ventilation|"Each subject will spend 2 hours receiving high-level noninvasive ventilation.~noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O."
11369821|NCT00537446|OG001|Outcome|Low-level Ventilation|"Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.~noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O."
11369822|NCT00537446|EG000|Reported Event|High-level Ventilation|"Each subject will spend 2 hours receiving high-level noninvasive ventilation.~noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O."
11369823|NCT00537446|EG001|Reported Event|Low-level Ventilation|"Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.~noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O."
11369824|NCT00536978|BG000|Baseline|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
11369825|NCT00536978|FG000|Participant Flow|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
11377154|NCT03903640|OG000|Outcome|Optune + Ipilimumab + Nivolumab|"Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.~Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses~Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.~Treatment may continue for up to 1 year"
11369826|NCT00536978|OG000|Outcome|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
11369827|NCT00536978|EG000|Reported Event|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
11369828|NCT00524485|BG000|Baseline|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
11369829|NCT00524485|FG000|Participant Flow|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
11369830|NCT00524485|OG000|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
11369831|NCT00524485|EG000|Reported Event|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
11369832|NCT00533351|BG000|Baseline|AGN201781 Followed by Placebo|
11369833|NCT00533351|BG001|Baseline|Placebo Followed by AGN201781|
11369834|NCT00533351|BG002|Baseline|Total|Total of all reporting groups
11369835|NCT00533351|FG000|Participant Flow|AGN201781 Followed by Placebo|
11369836|NCT00533351|FG001|Participant Flow|Placebo Followed by AGN201781|
11369837|NCT00533351|OG000|Outcome|AGN201781|
11369838|NCT00533351|OG001|Outcome|Placebo|
11369839|NCT00533351|EG000|Reported Event|AGN201781 Followed by Placebo|
11369840|NCT00533351|EG001|Reported Event|Placebo Followed by AGN201781|
11369841|NCT00529282|BG000|Baseline|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
11369842|NCT00529282|BG001|Baseline|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
11369843|NCT00529282|BG002|Baseline|Total|Total of all reporting groups
11369844|NCT00529282|FG000|Participant Flow|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
11369845|NCT00529282|FG001|Participant Flow|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
11369846|NCT00529282|OG000|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
11369847|NCT00529282|OG001|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
11369848|NCT00529282|EG000|Reported Event|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
11369849|NCT00529282|EG001|Reported Event|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
11369850|NCT00524134|BG000|Baseline|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
11189686|NCT02121067|BG000|Baseline|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
11189687|NCT02121067|FG000|Participant Flow|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
11189688|NCT02121067|OG000|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
11337245|NCT03581474|BG000|Baseline|aScope 3 Large|"Bronchoscopic procedure~Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large"
11337246|NCT03581474|FG000|Participant Flow|aScope 3 Large|"Bronchoscopic procedure~Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large"
11337247|NCT03581474|OG000|Outcome|aScope 3 Large|"Bronchoscopic procedure~Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large"
11337248|NCT03581474|EG000|Reported Event|aScope 3 Large|"Bronchoscopic procedure~Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large"
11337249|NCT03581825|BG000|Baseline|Total|All subjects dispensed a study lens
11337250|NCT03581825|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
11337251|NCT03581825|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
11337252|NCT03581825|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
11337253|NCT03581825|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
11337254|NCT03581825|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
11337255|NCT03581825|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
11337256|NCT03582215|BG000|Baseline|Part 1: Cream|"Part 1: Cream~Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337257|NCT03582215|BG001|Baseline|Part 1: Lotion|"Part 1: Lotion~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337258|NCT03582215|BG002|Baseline|Part 1: Spray 1|"Part 1: Spray 1~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337259|NCT03582215|BG003|Baseline|Part 1: Spray 2|"Part 1: Spray 2~Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337260|NCT03582215|BG004|Baseline|Part 2: Lotion|"Part 2: Lotion~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.~Part 2: Sunscreen Product #1, 2, 3 or 4: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337261|NCT03582215|BG005|Baseline|Part 2: Aerosol Spray|"Part 2: Aerosol Spray~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337262|NCT03582215|BG006|Baseline|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337263|NCT03582215|BG007|Baseline|Part 2: Pump Spray|"Part 2: Pump Spray~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337264|NCT03582215|BG008|Baseline|Total|Total of all reporting groups
11337265|NCT03582215|FG000|Participant Flow|Part 1: Cream|"Part 1: Cream:~Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337266|NCT03582215|FG001|Participant Flow|Part 1: Lotion|"Part 1: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337267|NCT03582215|FG002|Participant Flow|Part 1: Spray 1|"Part 1: Spray 1:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337268|NCT03582215|FG003|Participant Flow|Part 1: Spray 2|"Part 1: Spray 2:~Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337269|NCT03582215|FG004|Participant Flow|Part 2: Lotion|"Part 2: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11189689|NCT02121067|OG000|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
11189690|NCT02121067|EG000|Reported Event|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
11189691|NCT02121210|BG000|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
11189692|NCT02121210|BG001|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
11189693|NCT02121210|BG002|Baseline|Total|Total of all reporting groups
11189694|NCT02121210|FG000|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection q2w for 24 weeks
11189695|NCT02121210|FG001|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
11189696|NCT02121210|OG000|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
11189697|NCT02121210|OG001|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
11189698|NCT02121210|EG000|Reported Event|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
11369851|NCT00524134|FG000|Participant Flow|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
11189699|NCT02121210|EG001|Reported Event|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
11189700|NCT02121262|BG000|Baseline|Laser Photocoagulation|Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
11189701|NCT02121262|BG001|Baseline|Dexamethasone|Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
11189702|NCT02121262|BG002|Baseline|Total|Total of all reporting groups
11189703|NCT02121262|FG000|Participant Flow|Laser Photocoagulation|Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
11189704|NCT02121262|FG001|Participant Flow|Dexamethasone|Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
11189705|NCT02121262|OG000|Outcome|Laser Photocoagulation|Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
11189706|NCT02121262|OG001|Outcome|Dexamethasone|Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
11189707|NCT02121262|EG000|Reported Event|Laser Photocoagulation|Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
11189708|NCT02121262|EG001|Reported Event|Dexamethasone|Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
11189709|NCT02121301|BG000|Baseline|Low Dose - SkQ1|Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
11189710|NCT02121301|BG001|Baseline|High Dose - SkQ1|High Dose 1.55 μg/mL SkQ1 ophthalmic solution
11189711|NCT02121301|BG002|Baseline|Placebo (Vehicle)|Placebo (vehicle) ophthalmic solution
11189712|NCT02121301|BG003|Baseline|Total|Total of all reporting groups
11189713|NCT02121301|FG000|Participant Flow|Low Dose SkQ1|Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
11189714|NCT02121301|FG001|Participant Flow|High Dose SkQ1|High Dose 1.55 μg/mL SkQ1 ophthalmic solution
11189715|NCT02121301|FG002|Participant Flow|Placebo (Vehicle)|Placebo (vehicle) ophthalmic solution
11189716|NCT02121301|OG000|Outcome|Low Dose SkQ1|Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
11189717|NCT02121301|OG001|Outcome|High Dose SkQ1|High Dose 1.55 μg/mL SkQ1 ophthalmic solution
11189718|NCT02121301|OG002|Outcome|Placebo (Vehicle)|Placebo (vehicle) ophthalmic solution
11189719|NCT02121301|EG000|Reported Event|Low Dose SkQ1|Low Dose 0.155 µg/mL SkQ1 opthalmic solution
11189720|NCT02121301|EG001|Reported Event|High Dose SkQ1|High Dose 1.55 µg/mL SkQ1 opthalmic solution
11189721|NCT02121301|EG002|Reported Event|Placebo (Vehicle)|Placebo (vehicle) ophthalmic solution
11189722|NCT02121392|BG000|Baseline|Epidural Catheter Without Adductor Canal Nerve Block Catheter|"Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.~Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.~Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr."
11191705|NCT02133066|FG001|Participant Flow|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
11369852|NCT00524134|OG000|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
11369853|NCT00524134|EG000|Reported Event|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
11369854|NCT00527748|BG000|Baseline|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks."
11369855|NCT00527748|FG000|Participant Flow|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
11369856|NCT00527748|OG000|Outcome|Standard of Care|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
11369857|NCT00527748|EG000|Reported Event|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
11369858|NCT00517699|BG000|Baseline|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
11369859|NCT00517699|FG000|Participant Flow|Rituximab, Cytarabine, and Methotrexate (MTX)|Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
11369860|NCT00517699|OG000|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
11369861|NCT00517699|EG000|Reported Event|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
11369862|NCT00528775|BG000|Baseline|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
11369863|NCT00528775|FG000|Participant Flow|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
11369864|NCT00528775|OG000|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
11369865|NCT00528775|EG000|Reported Event|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
11369866|NCT00528437|BG000|Baseline|Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin.|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
11191706|NCT02133066|OG000|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
11369867|NCT00528437|FG000|Participant Flow|Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin.|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
11369868|NCT00528437|OG000|Outcome|Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin.|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
11369869|NCT00528437|EG000|Reported Event|Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin.|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
11369870|NCT00524511|BG000|Baseline|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
11369871|NCT00524511|BG001|Baseline|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
11369872|NCT00524511|BG002|Baseline|Total|Total of all reporting groups
11369873|NCT00524511|FG000|Participant Flow|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
11369874|NCT00524511|FG001|Participant Flow|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
11369875|NCT00524511|OG000|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
11369876|NCT00524511|OG001|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
11369877|NCT00524511|EG000|Reported Event|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
11369878|NCT00524511|EG001|Reported Event|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
11369879|NCT00517075|BG000|Baseline|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369880|NCT00517075|BG001|Baseline|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369881|NCT00517075|BG002|Baseline|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369882|NCT00517075|BG003|Baseline|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369883|NCT00517075|BG004|Baseline|Total|Total of all reporting groups
11369884|NCT00517075|FG000|Participant Flow|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369885|NCT00517075|FG001|Participant Flow|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369886|NCT00517075|FG002|Participant Flow|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369887|NCT00517075|FG003|Participant Flow|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369888|NCT00517075|OG000|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369889|NCT00517075|OG001|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369890|NCT00517075|OG002|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369891|NCT00517075|OG003|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369892|NCT00517075|EG000|Reported Event|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369893|NCT00517075|EG001|Reported Event|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11189723|NCT02121392|BG001|Baseline|Epidural Catheter With Adductor Canal Nerve Block Catheter|"Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.~Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the"
11189724|NCT02121392|BG002|Baseline|Total|Total of all reporting groups
11189725|NCT02121392|FG000|Participant Flow|Epidural Catheter Without Adductor Canal Nerve Block Catheter|"Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.~Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.~Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr."
11189726|NCT02121392|FG001|Participant Flow|Epidural Catheter With Adductor Canal Nerve Block Catheter|"Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.~Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the"
11189727|NCT02121392|OG000|Outcome|Epidural Catheter Without Adductor Canal Nerve Block Catheter|"Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.~Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.~Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr."
11189728|NCT02121392|OG001|Outcome|Epidural Catheter With Adductor Canal Nerve Block Catheter|"Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.~Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the"
11189729|NCT02121392|EG000|Reported Event|Epidural Catheter Without Adductor Canal Nerve Block Catheter|"Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.~Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.~Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr."
11191707|NCT02133066|OG001|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
11191708|NCT02133066|EG000|Reported Event|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking~Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.~Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
10850005|NCT00299546|FG000|Participant Flow|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
11189730|NCT02121392|EG001|Reported Event|Epidural Catheter With Adductor Canal Nerve Block Catheter|"Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.~Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the"
11189731|NCT02121418|BG000|Baseline|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
11189732|NCT02121418|FG000|Participant Flow|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
11189733|NCT02121418|OG000|Outcome|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
11189734|NCT02121418|EG000|Reported Event|Treatment (Decitabine, Cytarabine)|Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
11189735|NCT02121483|BG000|Baseline|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
11189736|NCT02121483|BG001|Baseline|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
11189737|NCT02121483|BG002|Baseline|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
11189738|NCT02121483|BG003|Baseline|Total|Total of all reporting groups
11189739|NCT02121483|FG000|Participant Flow|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
11189740|NCT02121483|FG001|Participant Flow|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
11189741|NCT02121483|FG002|Participant Flow|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
11189742|NCT02121483|OG000|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
11189743|NCT02121483|OG001|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
11189744|NCT02121483|OG002|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
11189745|NCT02121483|EG000|Reported Event|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
11189746|NCT02121483|EG001|Reported Event|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
11189747|NCT02121483|EG002|Reported Event|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
11191709|NCT02133066|EG001|Reported Event|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician~Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
11191710|NCT02133131|BG000|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
11191711|NCT02133131|BG001|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11191712|NCT02133131|BG002|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11191713|NCT02133131|BG003|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11191714|NCT02133131|BG004|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11191715|NCT02133131|BG005|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11191716|NCT02133131|BG006|Baseline|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11191717|NCT02133131|BG007|Baseline|Total|Total of all reporting groups
11191718|NCT02133131|FG000|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
11189748|NCT02121509|BG000|Baseline|FDC 1500 Fasted or L+M 1500 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189749|NCT02121509|BG001|Baseline|FDC 1500 Fed or L+M 1500 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189750|NCT02121509|BG002|Baseline|Total|Total of all reporting groups
11189751|NCT02121509|FG000|Participant Flow|FDC 1500 Fasted / L+M 1500 Fasted|"Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189752|NCT02121509|FG001|Participant Flow|L+M 1500 Fasted / FDC 1500 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189753|NCT02121509|FG002|Participant Flow|FDC 1500 Fed / L+M 1500 Fed|"Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189754|NCT02121509|FG003|Participant Flow|L+M 1500 Fed / FDC 1500 Fed|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
11189755|NCT02121509|OG000|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
11189756|NCT02121509|OG001|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
11189757|NCT02121509|OG002|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
11189758|NCT02121509|OG003|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
11189759|NCT02121509|EG000|Reported Event|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
11189760|NCT02121509|EG001|Reported Event|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
11189761|NCT02121509|EG002|Reported Event|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
11189762|NCT02121509|EG003|Reported Event|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
11189763|NCT02121522|BG000|Baseline|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
11189764|NCT02121522|FG000|Participant Flow|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
11189765|NCT02121522|OG000|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
11189766|NCT02121522|EG000|Reported Event|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
11189767|NCT02121535|BG000|Baseline|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
11189768|NCT02121535|BG001|Baseline|Sequence RTTR|Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4). T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
11189769|NCT02121535|BG002|Baseline|Total|Total of all reporting groups
11189770|NCT02121535|FG000|Participant Flow|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
11189771|NCT02121535|FG001|Participant Flow|Sequence RTTR|"Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).~T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
11189772|NCT02121535|OG000|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
11189773|NCT02121535|OG001|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
11189774|NCT02121535|EG000|Reported Event|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
11189775|NCT02121535|EG001|Reported Event|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
11189776|NCT02121535|EG002|Reported Event|Total (All Patients)|Total of all the participants analyzed
11189777|NCT02121756|BG000|Baseline|ARM A: Dipyridamole for 24 Weeks|Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
11189778|NCT02121756|BG001|Baseline|ARM B: Placebo for 12 Weeks, Then Dipyridamole for 12 Weeks|Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
11189779|NCT02121756|BG002|Baseline|Total|Total of all reporting groups
11189780|NCT02121756|FG000|Participant Flow|ARM A: Dipyridamole for 24 Weeks|Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
11189781|NCT02121756|FG001|Participant Flow|ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks|Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
11189782|NCT02121756|OG000|Outcome|ARM A: Dipyridamole for 24 Weeks|ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
11189783|NCT02121756|OG001|Outcome|ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks|Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
11189784|NCT02121756|OG000|Outcome|ARM A: Dipyridamole for 24 Weeks|Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
11189785|NCT02121756|OG001|Outcome|ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks|Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24.
11189786|NCT02121756|EG000|Reported Event|ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24|ARM A: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
11189787|NCT02121756|EG001|Reported Event|ARM B: Placebo for 12 Weeks From Baseline to Week 12|ARM B: Summary of Adverse Events for all participants randomized to receive Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12
11189788|NCT02121756|EG002|Reported Event|ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24|ARM B: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
11189789|NCT02121795|BG000|Baseline|F/TAF + 3rd Agent|Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189790|NCT02121795|BG001|Baseline|FTC/TDF + 3rd Agent|Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189791|NCT02121795|BG002|Baseline|Total|Total of all reporting groups
11189792|NCT02121795|FG000|Participant Flow|F/TAF + 3rd Agent|"Double-Blind Phase: emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.~Open-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program."
11189793|NCT02121795|FG001|Participant Flow|FTC/TDF + 3rd Agent|"Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.~Open-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program."
11189794|NCT02121795|OG000|Outcome|F/TAF + 3rd Agent|Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189795|NCT02121795|OG001|Outcome|FTC/TDF + 3rd Agent|Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189796|NCT02121795|EG000|Reported Event|F/TAF + 3rd Agent (Double-Blind)|Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg tablet) + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189797|NCT02121795|EG001|Reported Event|FTC/TDF + 3rd Agent (Double-Blind)|Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
11189798|NCT02121795|EG002|Reported Event|Open-Label F/TAF From F/TAF|Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group.
11189799|NCT02121795|EG003|Reported Event|Open-Label F/TAF From FTC/TDF|Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.
11189800|NCT02121808|BG000|Baseline|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
11189801|NCT02121808|FG000|Participant Flow|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
11189802|NCT02121808|OG000|Outcome|1. Supine + NIPPV|Intervention 1 : Supine + NIPPV
11189803|NCT02121808|OG001|Outcome|2. Supine + Tidal Volume Spontaneous Ventilation|Intervention 2 : Supine + Tidal volume spontaneous ventilation
11189804|NCT02121808|OG002|Outcome|3. Beach Chair (Back 25 Deg) + NIPPV|Intervention 3 : Beach chair (Back 25 deg) + NIPPV
11189805|NCT02121808|OG003|Outcome|4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous Ventil|Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation
11189806|NCT02121808|OG004|Outcome|5. Proclive (Global 25 Deg) + NIPPV|Intervention 5 : Proclive (Global 25 deg) + NIPPV
11189807|NCT02121808|OG005|Outcome|6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous Ventila|Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
11189808|NCT02121808|EG000|Reported Event|Position and Spontaneous vs Pressure Support|"The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.~Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation"
11189809|NCT02121834|BG000|Baseline|Cohort A-D Placebo|Placebo daily for 28 days
11189810|NCT02121834|BG001|Baseline|Cohort A: LY3050258|10 mg LY3050258, daily for 28 days
11189811|NCT02121834|BG002|Baseline|Cohort B: LY3050258|30 mg LY3050258, daily for 28 days
11189812|NCT02121834|BG003|Baseline|Cohort C: LY3050258|90 mg LY3050258, daily for 28 days
11189813|NCT02121834|BG004|Baseline|Cohort D: LY3050258|180 mg LY3050258, daily for 28 days
11189814|NCT02121834|BG005|Baseline|Cohort E: LY3050258|360 mg LY3050258, daily for 28 days
11189815|NCT02121834|BG006|Baseline|Cohort E Placebo|Placebo daily for 28 days
11189816|NCT02121834|BG007|Baseline|Total|Total of all reporting groups
11189817|NCT02121834|FG000|Participant Flow|Cohort A-D Placebo|Placebo daily for 28 days
11189818|NCT02121834|FG001|Participant Flow|Cohort A: 10 Milligram (mg) LY3050258|10 mg LY3050258, daily for 28 days
11189819|NCT02121834|FG002|Participant Flow|Cohort B: 30 mg LY3050258|30mg LY3050258, daily for 28 days
11189820|NCT02121834|FG003|Participant Flow|Cohort C: 90 mg LY3050258|90 mg LY3050258, daily for 28 days
11189821|NCT02121834|FG004|Participant Flow|Cohort D: 180 mg LY3050258|180 mg LY3050258, daily for 28 days
11189822|NCT02121834|FG005|Participant Flow|Cohort E: 360 mg LY3050258|360 mg LY3050258, daily for 28 days
11189823|NCT02121834|FG006|Participant Flow|Cohort E Placebo|Placebo daily for 28 days
11189824|NCT02121834|OG000|Outcome|Placebo Cohort A-D|Placebo daily for 28 days
11189825|NCT02121834|OG001|Outcome|10 mg LY3050258|10 mg LY3050258, daily for 28 days
11189826|NCT02121834|OG002|Outcome|30 mg LY3050258|30 mg LY3050258, daily for 28 days
11189827|NCT02121834|OG003|Outcome|90 mg LY3050258|90 mg LY3050258, daily for 28 days
11189828|NCT02121834|OG004|Outcome|180 mg LY3050258|180 mg LY3050258, daily for 28 days
11189829|NCT02121834|OG005|Outcome|360 mg LY3050258|360 mg LY3050258, daily for 28 days
11189830|NCT02121834|OG006|Outcome|Placebo Cohort E|Placebo daily for 28 days
11189831|NCT02121834|OG000|Outcome|10mg LY3050258|10 mg LY3050258, daily for 28 days
11189832|NCT02121834|OG001|Outcome|30mg LY3050258|30 mg LY3050258, daily for 28 days
11189833|NCT02121834|OG002|Outcome|90mg LY3050258|90 mg LY3050258, daily for 28 days
11189834|NCT02121834|OG003|Outcome|180mg LY3050258|180 mg LY3050258, daily for 28 days
11189835|NCT02121834|OG004|Outcome|360mg LY3050258|360mg LY3050258, daily for 28 days
11189836|NCT02121834|OG000|Outcome|10 mg LY3050258|10 mg LY3050258, daily for 28 days
11189837|NCT02121834|OG001|Outcome|30 mg LY3050258|30 mg LY3050258, daily for 28 days
11189838|NCT02121834|OG002|Outcome|90 mg LY3050258|90 mg LY3050258, daily for 28 days
11189839|NCT02121834|OG003|Outcome|180 mg LY3050258|180 mg LY3050258, daily for 28 days
11189840|NCT02121834|OG004|Outcome|360 mg LY3050258|360 mg LY3050258, daily for 28 days
11189841|NCT02121834|EG000|Reported Event|Cohort A-D Placebo|Placebo daily for 28 days
11189842|NCT02121834|EG001|Reported Event|Cohort A: 10 mg LY3050258|10 mg LY3050258, daily for 28 days
11189843|NCT02121834|EG002|Reported Event|Cohort B: 30 mg LY3050258|30 mg LY3050258, daily for 28 days
11189844|NCT02121834|EG003|Reported Event|Cohort C: 90 mg LY3050258|90 mg LY3050258, daily for 28 days
11189845|NCT02121834|EG004|Reported Event|Cohort D: 180 mg LY3050258|180 mg LY3050258, daily for 28 days
11189846|NCT02121834|EG005|Reported Event|Cohort E: 360 mg LY3050258|360 mg LY3050258, daily for 28 days
11189847|NCT02121834|EG006|Reported Event|Cohort E: Placebo|Placebo daily for 28 days
11189848|NCT02121847|BG000|Baseline|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
11191719|NCT02133131|FG001|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11369894|NCT00517075|EG002|Reported Event|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369895|NCT00517075|EG003|Reported Event|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
11369896|NCT00527982|BG000|Baseline|Celecoxib Treatment|Celecoxib 600 mg orally daily
11369897|NCT00527982|BG001|Baseline|No Treatment|
11369898|NCT00527982|BG002|Baseline|Total|Total of all reporting groups
11369899|NCT00527982|FG000|Participant Flow|Celecoxib Treatment|Celecoxib 600 mg orally daily
11369900|NCT00527982|FG001|Participant Flow|No Treatment|
11189849|NCT02121847|FG000|Participant Flow|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
11189850|NCT02121847|OG000|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
11369901|NCT00527982|OG000|Outcome|Celecoxib Treatment|Celecoxib 600 mg orally daily
11369902|NCT00527982|OG001|Outcome|No Treatment|
11369903|NCT00527982|EG000|Reported Event|Celecoxib Treatment|Celecoxib 600 mg orally daily
11369904|NCT00527982|EG001|Reported Event|No Treatment|
11369905|NCT00524459|BG000|Baseline|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
11369906|NCT00524459|FG000|Participant Flow|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
11369907|NCT00524459|OG000|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
11369908|NCT00524459|EG000|Reported Event|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
11369909|NCT00517361|BG000|Baseline|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
11369910|NCT00517361|FG000|Participant Flow|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
11369911|NCT00517361|OG000|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
11369912|NCT00517361|EG000|Reported Event|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
11369913|NCT00523939|BG000|Baseline|Lymphomatous|Subjects with Lymphomatous Meningitis
11369914|NCT00523939|BG001|Baseline|Leukemic|Subjects with Leukemic Meningitis
11369915|NCT00523939|BG002|Baseline|Total|Total of all reporting groups
11369916|NCT00523939|FG000|Participant Flow|Lymphomatous|Subjects with Lymphomatous Meningitis
11369917|NCT00523939|FG001|Participant Flow|Leukemic|Subjects with Leukemic Meningitis
11369918|NCT00523939|OG000|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
11369919|NCT00523939|OG001|Outcome|Leukemic|Subjects with Leukemic Meningitis
11369920|NCT00523939|EG000|Reported Event|All Subjects|Subjects with Lymphomatous or Leukemic Meningitis.
11369921|NCT00522457|BG000|Baseline|Ertumaxomab|
11369922|NCT00522457|FG000|Participant Flow|Ertumaxomab|
11369923|NCT00522457|OG000|Outcome|Ertumaxomab|
11369924|NCT00522457|EG000|Reported Event|Ertumaxomab|
11369925|NCT00526331|BG000|Baseline|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
11369926|NCT00526331|FG000|Participant Flow|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
11369927|NCT00526331|OG000|Outcome|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
11369928|NCT00526331|EG000|Reported Event|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
11369929|NCT00519090|BG000|Baseline|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
11369930|NCT00519090|BG001|Baseline|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
11369931|NCT00519090|BG002|Baseline|Total|Total of all reporting groups
11189851|NCT02121847|EG000|Reported Event|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
11369932|NCT00519090|FG000|Participant Flow|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
11369933|NCT00519090|FG001|Participant Flow|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
11369934|NCT00519090|OG000|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
11369935|NCT00519090|OG001|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
11369936|NCT00519090|EG000|Reported Event|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
11369937|NCT00519090|EG001|Reported Event|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
11369938|NCT00524394|BG000|Baseline|INFANTS|INFANTS 0 to 3 days of life >1500 G OR >32 WEEKS GA
11369939|NCT00524394|FG000|Participant Flow|Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA|Infants born at >32 weeks of gestagional age or > 1500gm between 0 to 3 Days of Life
11369940|NCT00524394|OG000|Outcome|INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA|INFANTS 0 to 3 days of life born with >1500 gm OR >32 WEEKS gestational age
11369941|NCT00524394|EG000|Reported Event|Infants0-3 Days of Life >1500g or >32 Weeks GA|Infants born at 32 weeks of gestacional age or >1500 mg at 0-3 days of life .
11369942|NCT00523809|BG000|Baseline|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
11369943|NCT00523809|FG000|Participant Flow|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
11369944|NCT00523809|OG000|Outcome|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
11369945|NCT00523809|EG000|Reported Event|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
11189852|NCT02121860|BG000|Baseline|Child-Pugh Class A|Mild Hepatic Impairment
11369946|NCT00522301|BG000|Baseline|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
11369947|NCT00522301|FG000|Participant Flow|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
11369948|NCT00522301|OG000|Outcome|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
11369949|NCT00522301|EG000|Reported Event|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
11189853|NCT02121860|BG001|Baseline|Child-Pugh Class B|Moderate Hepatic Impairment
11189854|NCT02121860|BG002|Baseline|Child-Pugh Class C|Severe Hepatic Impairment
11189855|NCT02121860|BG003|Baseline|Normal Hepatic Function|Medically healthy as determined by the investigator
11369950|NCT00517192|BG000|Baseline|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
11369951|NCT00517192|BG001|Baseline|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
11369952|NCT00517192|BG002|Baseline|Total|Total of all reporting groups
11369953|NCT00517192|FG000|Participant Flow|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
11369954|NCT00517192|FG001|Participant Flow|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
11369955|NCT00517192|OG000|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
11369956|NCT00517192|OG001|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
11369957|NCT00517192|EG000|Reported Event|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
11369958|NCT00517192|EG001|Reported Event|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
11369959|NCT00504985|BG000|Baseline|Fatigue in Emergency Center Patients|
11369960|NCT00504985|FG000|Participant Flow|Fatigue in Emergency Center Patients|
11369961|NCT00504985|OG000|Outcome|Fatigue in Emergency Center Patients|
11369962|NCT00504985|EG000|Reported Event|Fatigue in Emergency Center Patients|
11377155|NCT03903640|EG000|Reported Event|Optune + Ipilimumab + Nivolumab|"Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.~Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses~Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.~Treatment may continue for up to 1 year"
11369963|NCT00503581|BG000|Baseline|Regimen 1 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369964|NCT00503581|BG001|Baseline|Regimen 2 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369965|NCT00503581|BG002|Baseline|Regimen 3 (Surgery/Biopsy)|"(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369966|NCT00503581|BG003|Baseline|Total|Total of all reporting groups
11369967|NCT00503581|FG000|Participant Flow|Regimen 1 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369968|NCT00503581|FG001|Participant Flow|Regimen 2 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369969|NCT00503581|FG002|Participant Flow|Regimen 3 (Surgery/Biopsy)|"(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369970|NCT00503581|OG000|Outcome|Regimen 1 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11377156|NCT03853291|BG000|Baseline|PICT Workbook|PICT Workbook: The PICT workbook is a 31 page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
11377157|NCT03853291|BG001|Baseline|Information Pamphlet|"Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.~Information Pamphlet: Pamphlet with information about pain and dementia and links to Alzheimer's Association"
11369971|NCT00503581|OG001|Outcome|Regimen 2 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369972|NCT00503581|OG002|Outcome|Regimen 3 (Surgery/Biopsy)|"(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369973|NCT00503581|EG000|Reported Event|Regimen 1 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369974|NCT00503581|EG001|Reported Event|Regimen 2 (Megestrol Acetate, Surgery)|"Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Megestrol Acetate: given orally~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369975|NCT00503581|EG002|Reported Event|Regimen 3 (Surgery/Biopsy)|"(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization.~Biopsy: Undergo biopsy~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: undergo hysterectomy"
11369976|NCT00509600|BG000|Baseline|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
11369977|NCT00509600|FG000|Participant Flow|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
11369978|NCT00509600|OG000|Outcome|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
11369979|NCT00509600|EG000|Reported Event|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
11369980|NCT00515112|BG000|Baseline|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
11369981|NCT00515112|BG001|Baseline|Placebo|"Three subjects received the placebo~Placebo: placebo"
11369982|NCT00515112|BG002|Baseline|Total|Total of all reporting groups
11369983|NCT00515112|FG000|Participant Flow|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
11369984|NCT00515112|FG001|Participant Flow|Placebo|"Three subjects received the placebo~Placebo: placebo"
11369985|NCT00515112|OG000|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
11369986|NCT00515112|OG001|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
11189856|NCT02121860|BG004|Baseline|Total|Total of all reporting groups
11369987|NCT00515112|EG000|Reported Event|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
11369988|NCT00515112|EG001|Reported Event|Placebo|"Three subjects received the placebo~Placebo: placebo"
11369989|NCT00508872|BG000|Baseline|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
11369990|NCT00508872|FG000|Participant Flow|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
11369991|NCT00508872|OG000|Outcome|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
11369992|NCT00508872|EG000|Reported Event|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
11369993|NCT00514813|BG000|Baseline|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
11369994|NCT00514813|BG001|Baseline|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
11369995|NCT00514813|BG002|Baseline|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
11369996|NCT00514813|BG003|Baseline|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
11189857|NCT02121860|FG000|Participant Flow|Normal Hepatic Function|Medically healthy as determined by the investigator
11189858|NCT02121860|FG001|Participant Flow|Child-Pugh Class A|Mild hepatic impairment
11189859|NCT02121860|FG002|Participant Flow|Child-Pugh Class B|Moderate hepatic impairment
11189860|NCT02121860|FG003|Participant Flow|Child-Pugh Class C|Severe hepatic impairment
11369997|NCT00514813|BG004|Baseline|Total|Total of all reporting groups
11369998|NCT00514813|FG000|Participant Flow|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
11369999|NCT00514813|FG001|Participant Flow|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
11370000|NCT00514813|FG002|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
11370001|NCT00514813|FG003|Participant Flow|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
11370002|NCT00514813|OG000|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
11370003|NCT00514813|OG001|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
11370004|NCT00514813|OG002|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
11370005|NCT00514813|OG003|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
11370006|NCT00514813|EG000|Reported Event|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
11370007|NCT00514813|EG001|Reported Event|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
11370008|NCT00514813|EG002|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
11370009|NCT00514813|EG003|Reported Event|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
11370010|NCT00506064|BG000|Baseline|Melatonin|0.15 mg/kg capsules by mouth daily
11370011|NCT00506064|BG001|Baseline|Placebo|Starch capsules by mouth daily
11370012|NCT00506064|BG002|Baseline|Total|Total of all reporting groups
11189861|NCT02121860|OG000|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
11370013|NCT00506064|FG000|Participant Flow|Melatonin|0.15 mg/kg capsules by mouth daily
11370014|NCT00506064|FG001|Participant Flow|Placebo|Starch capsules by mouth daily
11370015|NCT00506064|OG000|Outcome|Melatonin|0.15 mg/kg capsules by mouth daily
11370016|NCT00506064|OG001|Outcome|Placebo|Starch capsules by mouth daily
11370017|NCT00506064|EG000|Reported Event|Melatonin|0.15 mg/kg capsules by mouth daily
11370018|NCT00506064|EG001|Reported Event|Placebo|Starch capsules by mouth daily
11370019|NCT00503880|BG000|Baseline|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
11370020|NCT00503880|FG000|Participant Flow|Phase I: Cohort #1|Clofarabine Dose Level 0: 10mg/m2
11370021|NCT00503880|FG001|Participant Flow|Phase I: Cohort #2|Clofarabine Dose Level +1: 15 mg/m2
11370022|NCT00503880|FG002|Participant Flow|Phase 1: Dose Cohort #3|Clofarabine Level +2: 20mg/m2
11370023|NCT00503880|FG003|Participant Flow|Phase I: Cohort #4|Clofarabine Level +3: 30 mg/m2
11370024|NCT00503880|FG004|Participant Flow|Phase II: Clinical Response|The presence of hematologic response is the outcome of interest in the Phase II component of the study. Clinical Response will include complete response and partial response.
11370025|NCT00503880|OG000|Outcome|Treatment|G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive days of the treatment course 2-4 hours following the end of the clofarabine infusion. (SOC) Clofarabine starting at dose level 0(Table 1) dose-10 mg/m2 IV over 1 hour daily starting on day 1 for the first 5 consecutive days of the treatment course.
11189862|NCT02121860|OG001|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
11189863|NCT02121860|OG002|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
11370026|NCT00503880|OG000|Outcome|Treatment|G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive days of the treatment course 2-4 hours following the end of the clofarabine infusion. (SOC) Clofarabine starting at dose level 0: dose-10 mg/m2 IV over 1 hour daily starting on day 1 for the first 5 consecutive days of the treatment course.
11370027|NCT00503880|OG000|Outcome|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
11370028|NCT00503880|EG000|Reported Event|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
11370029|NCT00511329|BG000|Baseline|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
11370030|NCT00511329|FG000|Participant Flow|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
11370031|NCT00511329|OG000|Outcome|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
11370032|NCT00511329|EG000|Reported Event|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
11370033|NCT00501228|BG000|Baseline|Filgrastim Injections|
11370034|NCT00501228|FG000|Participant Flow|Filgrastim Injections|
11370035|NCT00501228|OG000|Outcome|Filgrastim Injections|
11370036|NCT00501228|EG000|Reported Event|Filgrastim Injections|
11370037|NCT00496782|BG000|Baseline|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
11189864|NCT02121860|OG003|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
11189865|NCT02121860|EG000|Reported Event|IDN-6556|Single 50 mg oral dose of IDN-6556
11189866|NCT02121912|BG000|Baseline|FPH Pilairo Q CPAP Mask|"The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.~FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask"
11370038|NCT00496782|BG001|Baseline|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
11370039|NCT00496782|BG002|Baseline|Total|Total of all reporting groups
11370040|NCT00496782|FG000|Participant Flow|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
11370041|NCT00496782|FG001|Participant Flow|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
11370042|NCT00496782|OG000|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
11370043|NCT00496782|OG001|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
11370044|NCT00496782|EG000|Reported Event|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
11370045|NCT00496782|EG001|Reported Event|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
11370046|NCT00506909|BG000|Baseline|All Participants|
11189867|NCT02121912|BG001|Baseline|Any Other Market Released Nasal or Nasal-pillow CPAP Mask|"The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask~Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask"
11189868|NCT02121912|BG002|Baseline|Total|Total of all reporting groups
11370047|NCT00506909|FG000|Participant Flow|All Participants|
11189869|NCT02121912|FG000|Participant Flow|FPH Pilairo Q CPAP Mask|"The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.~FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask"
11189870|NCT02121912|FG001|Participant Flow|Any Other Market Released Nasal or Nasal-pillow CPAP Mask|"The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask~Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask"
11189871|NCT02121912|OG000|Outcome|FPH Pilairo Q CPAP Mask|"The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.~FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask"
11189872|NCT02121912|OG001|Outcome|Any Other Market Released Nasal or Nasal-pillow CPAP Mask|"The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask~Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask"
11189873|NCT02121912|EG000|Reported Event|FPH Pilairo Q CPAP Mask|"The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.~FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask"
11189874|NCT02121912|EG001|Reported Event|Any Other Market Released Nasal or Nasal-pillow CPAP Mask|"The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask~Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask"
11189875|NCT02122146|BG000|Baseline|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
11191720|NCT02133131|FG002|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11370048|NCT00506909|OG000|Outcome|All Participants|
11370049|NCT00506909|EG000|Reported Event|All Participants|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
11370050|NCT00487578|BG000|Baseline|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370051|NCT00487578|BG001|Baseline|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370052|NCT00487578|BG002|Baseline|Total|Total of all reporting groups
11370053|NCT00487578|FG000|Participant Flow|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370054|NCT00487578|FG001|Participant Flow|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370055|NCT00487578|OG000|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370056|NCT00487578|OG001|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370057|NCT00487578|EG000|Reported Event|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370058|NCT00487578|EG001|Reported Event|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
11370059|NCT00503009|BG000|Baseline|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
11370060|NCT00503009|BG001|Baseline|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
11370061|NCT00503009|BG002|Baseline|Placebo Diskus BID|Placebo twice daily
11370062|NCT00503009|BG003|Baseline|Total|Total of all reporting groups
11191721|NCT02133131|FG003|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11370063|NCT00503009|FG000|Participant Flow|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
11370064|NCT00503009|FG001|Participant Flow|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
11370065|NCT00503009|FG002|Participant Flow|Placebo Diskus BID|Placebo twice daily
11370066|NCT00503009|OG000|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
11370067|NCT00503009|OG001|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
11370068|NCT00503009|OG002|Outcome|Placebo Diskus BID|Placebo twice daily
11370069|NCT00503009|EG000|Reported Event|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
11370070|NCT00503009|EG001|Reported Event|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
11370071|NCT00503009|EG002|Reported Event|Placebo Diskus BID|Placebo twice daily
11370072|NCT00500045|BG000|Baseline|Treatment|"Oral niacin~nicotinic acid: niacin 1500 mg po qd~0 participants analyzed for the overall number of baseline participants. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules."
11370073|NCT00500045|FG000|Participant Flow|Treatment|"Oral niacin~nicotinic acid: niacin 1500 mg po qd~0 participants started and completed in each arm/group. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules."
11370074|NCT00500045|OG000|Outcome|Treatment|"Oral niacin~nicotinic acid: niacin 1500 mg po qd~0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules."
11370075|NCT00500045|EG000|Reported Event|Adverse Events|0 participants at risk (for each arm/group in both serious and other adverse events). The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
11370076|NCT00499590|BG000|Baseline|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
11370077|NCT00499590|BG001|Baseline|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370078|NCT00499590|BG002|Baseline|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370079|NCT00499590|BG003|Baseline|Total|Total of all reporting groups
11370080|NCT00499590|FG000|Participant Flow|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
11370081|NCT00499590|FG001|Participant Flow|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370082|NCT00499590|FG002|Participant Flow|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370083|NCT00499590|OG000|Outcome|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
11370084|NCT00499590|OG001|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370085|NCT00499590|OG002|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370086|NCT00499590|OG000|Outcome|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
11370087|NCT00499590|EG000|Reported Event|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
11370088|NCT00499590|EG001|Reported Event|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370089|NCT00499590|EG002|Reported Event|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
11370090|NCT00501345|BG000|Baseline|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
11370091|NCT00501345|FG000|Participant Flow|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
11370092|NCT00501345|OG000|Outcome|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
11370093|NCT00501345|EG000|Reported Event|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
11370094|NCT00496756|BG000|Baseline|Sorafenib|"sorafenib tosylate: initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg~flow cytometry: 15 ml of blood drawn for flow cytometry of T4/T8, NK, CD25+, and Fox p3 testing obtained at baseline and on days 28, 56, 84, and 112~laboratory biomarker analysis: 15 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained at baseline.10 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained on days 28, 56, 84 and 112"
11370095|NCT00496756|FG000|Participant Flow|Sorafenib|"The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.~Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.~A treatment cycle will be 4 weeks.~Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol."
11370096|NCT00496756|OG000|Outcome|Sorafenib|"The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.~Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.~A treatment cycle will be 4 weeks.~Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol."
11191722|NCT02133131|FG004|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11370097|NCT00496756|EG000|Reported Event|Sorafenib|"The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.~Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.~A treatment cycle will be 4 weeks.~Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol."
11370098|NCT00495716|BG000|Baseline|Episodic Treatment Arm|"800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence~acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence"
11370099|NCT00495716|BG001|Baseline|Suppressive Therapy Arm|"400 mg acyclovir orally twice daily for 1 year~acyclovir: 400 mg acyclovir orally twice daily for 1 year"
11370100|NCT00495716|BG002|Baseline|Total|Total of all reporting groups
11370101|NCT00495716|FG000|Participant Flow|Episodic Treatment Arm|"800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence~acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence"
11370102|NCT00495716|FG001|Participant Flow|Suppressive Therapy Arm|"400 mg acyclovir orally twice daily for 1 year~acyclovir: 400 mg acyclovir orally twice daily for 1 year"
11370103|NCT00495716|OG000|Outcome|Episodic Treatment Arm|"800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence~acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence"
11370104|NCT00495716|OG001|Outcome|Suppressive Therapy Arm|"400 mg acyclovir orally twice daily for 1 year~acyclovir: 400 mg acyclovir orally twice daily for 1 year"
11370105|NCT00495716|EG000|Reported Event|Episodic Treatment Arm|"800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence~acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence"
11370106|NCT00495716|EG001|Reported Event|Suppressive Therapy Arm|"400 mg acyclovir orally twice daily for 1 year~acyclovir: 400 mg acyclovir orally twice daily for 1 year"
11370107|NCT00500890|BG000|Baseline|Carboplatin + Etoposide + Vincristine|"Carboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.~Carboplatin: 350 mg/m^2 by vein, Over 2 Hours x 2 Days~Etoposide: 100 mg/m^2 by vein, Over 1 Hour x 5 Days~Vincristine: 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5~Radiation Therapy: Radiation treatment over a period of about 6 weeks."
11370108|NCT00500890|BG001|Baseline|Cyclophosphamide + Etoposide + Vincristine|"Cyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.~Cyclophosphamide: 1 g/m^2 by vein, Over 1 Hour x 2 Days~Etoposide: 100 mg/m^2 by vein, Over 1 Hour x 5 Days~Vincristine: 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5~Radiation Therapy: Radiation treatment over a period of about 6 weeks."
11370109|NCT00500890|BG002|Baseline|Total|Total of all reporting groups
11370110|NCT00500890|FG000|Participant Flow|Carboplatin + Etoposide + Vincristine|"Carboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.~Carboplatin: 350 mg/m^2 by vein, Over 2 Hours x 2 Days~Etoposide: 100 mg/m^2 by vein, Over 1 Hour x 5 Days~Vincristine: 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5~Radiation Therapy: Radiation treatment over a period of about 6 weeks."
11370111|NCT00500890|FG001|Participant Flow|Cyclophosphamide + Etoposide + Vincristine|"Cyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.~Cyclophosphamide: 1 g/m^2 by vein, Over 1 Hour x 2 Days~Etoposide: 100 mg/m^2 by vein, Over 1 Hour x 5 Days~Vincristine: 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5~Radiation Therapy: Radiation treatment over a period of about 6 weeks."
11370112|NCT00500890|OG000|Outcome|Carboplatin + Etoposide + Vincristine|Study participants randomized to receive chemotherapy regimine containing Carboplatin, Etoposide and Vincristine.
11370113|NCT00500890|OG001|Outcome|Cyclophosphamide + Etoposide + Vincristine|Study participants randomized to receive chemotherapy regimine containing Cyclophosphamide, Etoposide and Vincristine.
11370114|NCT00500890|EG000|Reported Event|Carboplatin + Etoposide + Vincristine|Study participants randomized to receive chemotherapy regimine containing Carboplatin, Etoposide and Vincristine.
11370115|NCT00500890|EG001|Reported Event|Cyclophosphamide + Etoposide + Vincristine|Study participants randomized to receive chemotherapy regimine containing Cyclophosphamide, Etoposide and Vincristine.
11370116|NCT00503841|BG000|Baseline|Erlotinib Hydrochloride|If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
11370117|NCT00503841|FG000|Participant Flow|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis~Treatment continues in the absence of disease progression or unacceptable toxicity.~Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
11370118|NCT00503841|OG000|Outcome|Erlotinib Hydrochloride|Patients must be willing to consider treatment with erlotinib, in the event they are eligible for the treatment phase of the study. Erlotinib (Tarceva®) will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib (Tarceva®), at a dose of 150 mg/day mg by mouth. Patients will be instructed to take tablets once daily. The day of planned surgical resection of the invasive breast cancer will be considered day 0. Patients will undergo baseline physical examination and performance status evaluation on or before day -14. Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.
11189876|NCT02122146|BG001|Baseline|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370119|NCT00503841|OG000|Outcome|Erlotinib Hydrochloride|"Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.~immunohistochemistry staining method: Assessed at the time of the initial biopsy and at the time of surgery.~laboratory biomarker analysis: Correlative studies~biopsy: 14 days prior to surgery~conventional surgery: 14 days after taking study drug erlotinib hydrochloride.~neoadjuvant therapy: 14 days after taking study drug erlotinib hydrochloride."
11370120|NCT00503841|OG000|Outcome|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis~Treatment continues in the absence of disease progression or unacceptable toxicity.~Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
11370121|NCT00503841|EG000|Reported Event|Erlotinib Hydrochloride|Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.
11370122|NCT00493025|BG000|Baseline|Paclitaxel, Cisplatin, ZD1839 and Radiotherapy|"Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 Radiotherapy Followed by Postoperative ZD1839~immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,"
11189877|NCT02122146|BG002|Baseline|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370123|NCT00493025|FG000|Participant Flow|Paclitaxel, Cisplatin, ZD1839 and Radiotherapy|"Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Posto ZD1839~paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,"
11370124|NCT00493025|OG000|Outcome|Paclitaxel, Cisplatin, ZD1839 and Radiotherapy|"Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~adj therapy: Combined Modality Paclitaxel, Cisplatin,"
11370125|NCT00493025|OG000|Outcome|Paclitaxel, Cisplatin, ZD1839 and Radiotherapy|"Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Posto ZD1839~paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,"
11370126|NCT00493025|EG000|Reported Event|Paclitaxel, Cisplatin, ZD1839 and Radiotherapy|"Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839~adj therapy: Combined Modality Paclitaxel, Cisplatin,"
11370127|NCT00491400|BG000|Baseline|Fenofibrate First|Fenofibrate First and Atorvastatin Second
11370128|NCT00491400|BG001|Baseline|Atorvastatin First|Atorvastatin First and Fenofibrate Second
11370129|NCT00491400|BG002|Baseline|Total|Total of all reporting groups
11370130|NCT00491400|FG000|Participant Flow|Fenofibrate First|Participants randomized to receive fenofibrate first and atorvastatin second
11370131|NCT00491400|FG001|Participant Flow|Atorvastatin First|Participants randomized to receive atorvastatin first and fenofibrate second
11370132|NCT00491400|OG000|Outcome|Fenofibrate Treatment|Effect of fenofibrate on brachial artery FMD
11370133|NCT00491400|OG001|Outcome|Atorvastatin Treatment|Effect of atorvastatin on brachial artery FMD
11191723|NCT02133131|FG005|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370134|NCT00491400|OG000|Outcome|Fenofibrate|Effect of fenofibrate treatment on lipid profile
11370135|NCT00491400|OG001|Outcome|Atorvastatin|Effect of atorvastatin treatment on lipid profile
11370136|NCT00491400|EG000|Reported Event|Fenofibrate First|Fenofibrate First and Atorvastatin Second
11370137|NCT00491400|EG001|Reported Event|Atorvastatin First|Atorvastatin First and Fenofibrate Second
11370138|NCT00490776|BG000|Baseline|Panobinostat 20 mg|Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
11370139|NCT00490776|FG000|Participant Flow|Panobinostat 20 mg|Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
11370140|NCT00490776|OG000|Outcome|Panobinostat 20 mg|Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
11370141|NCT00490776|EG000|Reported Event|Panobinostat 20 mg|Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
11370142|NCT00487162|BG000|Baseline|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
11370143|NCT00487162|BG001|Baseline|Intensive Glycemic Control|In this treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
11370144|NCT00487162|BG002|Baseline|Total|Total of all reporting groups
11370145|NCT00487162|FG000|Participant Flow|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
11370146|NCT00487162|FG001|Participant Flow|Intensive Glycemic Control|In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
11370147|NCT00487162|OG000|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
11370148|NCT00487162|OG001|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
11370149|NCT00487162|EG000|Reported Event|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
11370150|NCT00487162|EG001|Reported Event|Intensive Glycemic Control|Subjects randomized to this group had glucose levels monitored hourly and when >110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
11370151|NCT00487981|BG000|Baseline|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
11189878|NCT02122146|BG003|Baseline|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370152|NCT00487981|FG000|Participant Flow|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
11370153|NCT00487981|OG000|Outcome|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
11370154|NCT00487981|EG000|Reported Event|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
11370155|NCT00491387|BG000|Baseline|Metoprolol Succinate|will receive I-123 MIBG innervation imaging before and after metoprolol succinate
11370156|NCT00491387|FG000|Participant Flow|Group 1|Treated with metoprolol succinate
11370157|NCT00491387|OG000|Outcome|Metoprolol Succinate|"Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.~Metoprolol Succinate: Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute."
11370158|NCT00491387|EG000|Reported Event|Metoprolol Succinate|Patients receive I-123 MIBG imaging before and after metoprolol succinate.
11370159|NCT00475332|BG000|Baseline|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
11370160|NCT00475332|FG000|Participant Flow|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
11370161|NCT00475332|OG000|Outcome|Radiation Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
11370162|NCT00475332|OG000|Outcome|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
11370163|NCT00475332|EG000|Reported Event|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
11370164|NCT00483119|BG000|Baseline|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
11370165|NCT00483119|BG001|Baseline|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
11370166|NCT00483119|BG002|Baseline|Total|Total of all reporting groups
11370167|NCT00483119|FG000|Participant Flow|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
11370168|NCT00483119|FG001|Participant Flow|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
11370169|NCT00483119|OG000|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
11370170|NCT00483119|OG001|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
11370171|NCT00483119|EG000|Reported Event|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
11370172|NCT00483119|EG001|Reported Event|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
11370173|NCT00487461|BG000|Baseline|Control Group|"Placebo tablet~Placebo: Placebo tablet"
11370174|NCT00487461|BG001|Baseline|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370175|NCT00487461|BG002|Baseline|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370176|NCT00487461|BG003|Baseline|Total|Total of all reporting groups
11370177|NCT00487461|FG000|Participant Flow|Control Group|"Placebo tablet~Placebo: Placebo tablet"
11370178|NCT00487461|FG001|Participant Flow|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370179|NCT00487461|FG002|Participant Flow|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370180|NCT00487461|OG000|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
11370181|NCT00487461|OG001|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370182|NCT00487461|OG002|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370183|NCT00487461|EG000|Reported Event|Control Group|"Placebo tablet~Placebo: Placebo tablet"
11370184|NCT00487461|EG001|Reported Event|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370185|NCT00487461|EG002|Reported Event|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
11370186|NCT00484718|BG000|Baseline|All Participants|All randomized participants who received placebo matched to celecoxib and oxycodone, celecoxib 100 mg and oxycodone 20 mg orally, twice daily in one of the 6 treatment sequences in each of three treatment periods.
11370187|NCT00484718|FG000|Participant Flow|Placebo Then Celecoxib Then Oxycodone|Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), then in treatment period 2 participants received celecoxib 100 milligram (mg) (200 milligram per day [mg/day]) capsule orally, twice daily on Days 1-14 followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
11370188|NCT00484718|FG001|Participant Flow|Placebo Then Oxycodone Then Celecoxib|Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally twice daily on Days 1-14 followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
11370189|NCT00484718|FG002|Participant Flow|Celecoxib Then Placebo Then Oxycodone|Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
11191724|NCT02133131|FG006|Participant Flow|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370190|NCT00484718|FG003|Participant Flow|Celecoxib Then Oxycodone Then Placebo|Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1, then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]). Each 2-week treatment period was separated by a 2-week washout period.
11370191|NCT00484718|FG004|Participant Flow|Oxycodone Then Placebo Then Celecoxib|Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
11370192|NCT00484718|FG005|Participant Flow|Oxycodone Then Celecoxib Then Placebo|Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]). Each 2-week treatment period was separated by a 2-week washout period.
11370193|NCT00484718|OG000|Outcome|Placebo|Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 84 (Days 1-14 of treatment periods 1, 2, 3 and for 14 days prior to each of three treatment periods [i.e. during 2-week washout period])
11370194|NCT00484718|OG001|Outcome|Celecoxib 100 mg|Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
11370195|NCT00484718|OG002|Outcome|Oxycodone 20 mg|Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
11370196|NCT00484718|EG000|Reported Event|Placebo|Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 84 (Days 1-14 of treatment periods 1, 2, 3 and for 14 days prior to each of three treatment periods [i.e. during 2-week washout period])
11370197|NCT00484718|EG001|Reported Event|Celecoxib 100 mg|Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
11370198|NCT00484718|EG002|Reported Event|Oxycodone 20 mg|Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
11370199|NCT00477230|BG000|Baseline|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
11370200|NCT00477230|BG001|Baseline|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
11370201|NCT00477230|BG002|Baseline|Total|Total of all reporting groups
11370202|NCT00477230|FG000|Participant Flow|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
11370203|NCT00477230|FG001|Participant Flow|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
11370204|NCT00477230|OG000|Outcome|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
11370205|NCT00477230|OG001|Outcome|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
11370206|NCT00477230|EG000|Reported Event|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
11370207|NCT00477230|EG001|Reported Event|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
11189879|NCT02122146|BG004|Baseline|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370208|NCT00470067|BG000|Baseline|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
11370209|NCT00470067|FG000|Participant Flow|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
11370210|NCT00470067|OG000|Outcome|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
11191725|NCT02133131|OG000|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
11191726|NCT02133131|OG001|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11370211|NCT00470067|EG000|Reported Event|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
11370212|NCT00476827|BG000|Baseline|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
11370213|NCT00476827|BG001|Baseline|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370214|NCT00476827|BG002|Baseline|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370215|NCT00476827|BG003|Baseline|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370216|NCT00476827|BG004|Baseline|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
11370217|NCT00476827|BG005|Baseline|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
11370218|NCT00476827|BG006|Baseline|Total|Total of all reporting groups
11370219|NCT00476827|FG000|Participant Flow|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
11370220|NCT00476827|FG001|Participant Flow|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370221|NCT00476827|FG002|Participant Flow|Bevacizumab / Irinotecan (Camptosar®, CPT-11)|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370222|NCT00476827|FG003|Participant Flow|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370223|NCT00476827|FG004|Participant Flow|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
11370224|NCT00476827|FG005|Participant Flow|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
11370225|NCT00476827|OG000|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
11370226|NCT00476827|OG001|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370227|NCT00476827|OG002|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370228|NCT00476827|OG003|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
11370229|NCT00476827|OG004|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
11370230|NCT00476827|OG005|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
11370231|NCT00476827|EG000|Reported Event|Avastin (Bevacizumab)/ Capecitabine (Xeloda)|
11370232|NCT00476827|EG001|Reported Event|Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)|
11370233|NCT00476827|EG002|Reported Event|Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine|
11370234|NCT00476827|EG003|Reported Event|Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)|
11370235|NCT00475657|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
11370236|NCT00475657|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
10850006|NCT00299546|FG001|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
11370237|NCT00475657|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
11370238|NCT00475657|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
11370239|NCT00472082|BG000|Baseline|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
11370240|NCT00472082|FG000|Participant Flow|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
11370241|NCT00472082|OG000|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
11370242|NCT00472082|EG000|Reported Event|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
11370243|NCT00478062|BG000|Baseline|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
11370244|NCT00478062|FG000|Participant Flow|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
10850007|NCT00299546|FG002|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
11370245|NCT00478062|OG000|Outcome|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
11370246|NCT00478062|EG000|Reported Event|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
11370247|NCT00470574|BG000|Baseline|Vaccine Therapy and QS21|"Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.~Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.~After completion of study treatment, patients are followed every 3 months"
11370248|NCT00470574|FG000|Participant Flow|Vaccine Therapy and QS21|"Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.~Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.~After completion of study treatment, patients are followed every 3 months"
11370249|NCT00470574|OG000|Outcome|Vaccine Therapy and QS21|"Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.~Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.~After completion of study treatment, patients are followed every 3 months"
11370250|NCT00470574|EG000|Reported Event|Vaccine Therapy and QS21|"Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.~Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.~After completion of study treatment, patients are followed every 3 months"
11370251|NCT00467753|BG000|Baseline|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
11370252|NCT00467753|BG001|Baseline|Sugar Pill|Placebo : Dosage similar to active drug
11370253|NCT00467753|BG002|Baseline|Total|Total of all reporting groups
11370254|NCT00467753|FG000|Participant Flow|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
11370255|NCT00467753|FG001|Participant Flow|Sugar Pill|Placebo : Dosage similar to active drug
11370256|NCT00467753|OG000|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine: Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
11370257|NCT00467753|OG001|Outcome|Sugar Pill|"Patients are given either active or inactive intervention.~Placebo/sugar pill: Dosage similar to active drug"
11370258|NCT00467753|OG000|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
11370259|NCT00467753|OG001|Outcome|Sugar Pill|Placebo : Dosage similar to active drug
11370260|NCT00467753|OG000|Outcome|Oxcarbazepine|There were not enough participants in this study to analyze results.
11370261|NCT00467753|OG001|Outcome|Placebo/Sugarpill|There were not enough participants in this study to analyze results.
11370262|NCT00467753|EG000|Reported Event|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
11370263|NCT00467753|EG001|Reported Event|Sugar Pill|Placebo : Dosage similar to active drug
11370264|NCT00456612|BG000|Baseline|Single Arm|Single arm Phase II Study
11370265|NCT00456612|FG000|Participant Flow|Cyberknife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
11370266|NCT00456612|OG000|Outcome|Cyberknife|"Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.~CyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses."
11370267|NCT00456612|OG000|Outcome|Single Arm|Single arm Phase II Study
11370268|NCT00456612|EG000|Reported Event|Single Arm Study|Single arm Phase II Study
11370269|NCT00469612|BG000|Baseline|NeuroVision's NVC Treatment for Low Myopia|"NeuroVision's NVC treatment for low myopia~NeuroVision's NVC treatment for Low Myopia: NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
11370270|NCT00469612|BG001|Baseline|No Intervention Group|The subjects in this group will serve as controls and will be the no intervention group.
11370271|NCT00469612|BG002|Baseline|Total|Total of all reporting groups
11370272|NCT00469612|FG000|Participant Flow|NeuroVision's NVC Treatment for Low Myopia|"NeuroVision's NVC treatment for low myopia~NeuroVision's NVC treatment for Low Myopia: NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
11370273|NCT00469612|FG001|Participant Flow|No Intervention Group|The subjects in this group will serve as controls and will be the no intervention group.
11370274|NCT00469612|OG000|Outcome|NeuroVision's NVC Treatment for Low Myopia|"NeuroVision's NVC treatment for low myopia~NeuroVision's NVC treatment for Low Myopia: NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
11370275|NCT00469612|OG001|Outcome|No Intervention Group|The subjects in this group will serve as controls and will be the no intervention group.
11370276|NCT00469612|EG000|Reported Event|NeuroVision's NVC Treatment for Low Myopia|"NeuroVision's NVC treatment for low myopia~NeuroVision's NVC treatment for Low Myopia: NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
11370277|NCT00469612|EG001|Reported Event|No Intervention Group|The subjects in this group will serve as controls and will be the no intervention group.
11370278|NCT00461812|BG000|Baseline|All Participants|"Mometasone~or~Advair"
11370279|NCT00461812|FG000|Participant Flow|All Participants|"Mometasone~or~Advair"
11370280|NCT00461812|OG000|Outcome|Mometasone|Mometasone
11370281|NCT00461812|OG001|Outcome|Advair|Advair
11370282|NCT00461812|EG000|Reported Event|All Participants|"Mometasone~or~Advair~Adverse event data and the number of participants assigned to each Arm/Group is unknown because the PI left the institution and this information is unavailable"
11370283|NCT00459121|BG000|Baseline|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
11370284|NCT00459121|FG000|Participant Flow|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
11189880|NCT02122146|BG005|Baseline|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370285|NCT00459121|OG000|Outcome|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
11370286|NCT00459121|OG000|Outcome|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
11191727|NCT02133131|OG002|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11191728|NCT02133131|OG003|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11370287|NCT00459121|EG000|Reported Event|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
11370288|NCT00461682|BG000|Baseline|Overall Study Arm|
11370289|NCT00461682|FG000|Participant Flow|Total Population|Eligible participants were planned to receive oral SB-705498 eight hundred (800) milligrams (mg) once daily or matching Placebo in a randomized manner over two treatment periods once in the study. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
11370290|NCT00461682|OG000|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
11370291|NCT00461682|OG001|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
11370292|NCT00461682|EG000|Reported Event|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
11370293|NCT00461682|EG001|Reported Event|SB-705498|Participants were planned to receive oral SB-705498 800 milligrams (mg) once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
11370294|NCT00462904|BG000|Baseline|BPI Infusion Group|"BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours~BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours"
11370295|NCT00462904|FG000|Participant Flow|BPI Infusion Group|"BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours~BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours"
11370296|NCT00462904|OG000|Outcome|BPI Infusion Group|"BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours~BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours"
11370297|NCT00462904|EG000|Reported Event|BPI Infusion Group|"BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours~BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours"
11370298|NCT00450333|BG000|Baseline|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
11370299|NCT00450333|BG001|Baseline|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
11370300|NCT00450333|BG002|Baseline|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
11370301|NCT00450333|BG003|Baseline|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
11370302|NCT00450333|BG004|Baseline|Total|Total of all reporting groups
11370303|NCT00450333|FG000|Participant Flow|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
11370304|NCT00450333|FG001|Participant Flow|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
11370305|NCT00450333|FG002|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
11370306|NCT00450333|FG003|Participant Flow|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
11370307|NCT00450333|OG000|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
11370308|NCT00450333|OG001|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
11370309|NCT00450333|OG002|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
11370310|NCT00450333|OG003|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
11370311|NCT00450333|EG000|Reported Event|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
11370312|NCT00450333|EG001|Reported Event|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
11370313|NCT00450333|EG002|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
11370314|NCT00450333|EG003|Reported Event|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
11370315|NCT00455143|BG000|Baseline|All Participants|All participants enrolled in study. Study never unblinded. Information not available by arms.
11370316|NCT00455143|FG000|Participant Flow|All Participants|All participants enrolled in study. Information not available per arm. Study never unblinded.
11370317|NCT00455143|OG000|Outcome|Dexmedetomidine|"Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.~Precedex (Dexmedetomidine): Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU."
11370318|NCT00455143|OG001|Outcome|Placebo|"Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively or until discharge from the PACU.~Precedex (Dexmedetomidine): Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU."
11370319|NCT00455143|EG000|Reported Event|All Participants|All participants enrolled in study, data missing for 3 participants. Information not available per arm. Study never unblinded.
11370320|NCT00456989|BG000|Baseline|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
11370321|NCT00456989|FG000|Participant Flow|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
11370322|NCT00456989|OG000|Outcome|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
11370323|NCT00456989|OG000|Outcome|Taxotere and Doxil|"There is no data to report. Data for this trial was not analyzed, the PI left institution.~Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~There is no data to report. Data for this trial was"
11370324|NCT00456989|EG000|Reported Event|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
11370325|NCT00448682|BG000|Baseline|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
11189881|NCT02122146|BG006|Baseline|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189882|NCT02122146|BG007|Baseline|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189883|NCT02122146|BG008|Baseline|Total|Total of all reporting groups
11189884|NCT02122146|FG000|Participant Flow|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
11191729|NCT02133131|OG004|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11191730|NCT02133131|OG005|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370326|NCT00448682|FG000|Participant Flow|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
11370327|NCT00448682|OG000|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
11370328|NCT00448682|EG000|Reported Event|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
11370329|NCT00454571|BG000|Baseline|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
11370330|NCT00454571|BG001|Baseline|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
11370331|NCT00454571|BG002|Baseline|Total|Total of all reporting groups
11370332|NCT00454571|FG000|Participant Flow|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
11370333|NCT00454571|FG001|Participant Flow|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
11370334|NCT00454571|OG000|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
11370335|NCT00454571|OG001|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
11370336|NCT00454571|EG000|Reported Event|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
11370337|NCT00454571|EG001|Reported Event|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
11370338|NCT00452361|BG000|Baseline|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
11370339|NCT00452361|BG001|Baseline|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
11370340|NCT00452361|BG002|Baseline|Total|Total of all reporting groups
11189885|NCT02122146|FG001|Participant Flow|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11191731|NCT02133131|OG006|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370341|NCT00452361|FG000|Participant Flow|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
11370342|NCT00452361|FG001|Participant Flow|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
11370343|NCT00452361|OG000|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
11370344|NCT00452361|OG001|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
11370345|NCT00452361|EG000|Reported Event|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
11370346|NCT00452361|EG001|Reported Event|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
11370347|NCT00443040|BG000|Baseline|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
11370348|NCT00443040|BG001|Baseline|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
11370349|NCT00443040|BG002|Baseline|Placebo|Matching Placebo
11370350|NCT00443040|BG003|Baseline|Total|Total of all reporting groups
11370351|NCT00443040|FG000|Participant Flow|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
11370352|NCT00443040|FG001|Participant Flow|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
11370353|NCT00443040|FG002|Participant Flow|Placebo|Matching Placebo
11370354|NCT00443040|OG000|Outcome|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
11370355|NCT00443040|OG001|Outcome|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
11370356|NCT00443040|OG002|Outcome|Placebo|Matching Placebo
11370357|NCT00443040|EG000|Reported Event|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
11191732|NCT02133131|EG000|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
11370358|NCT00443040|EG001|Reported Event|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
11370359|NCT00443040|EG002|Reported Event|Placebo|Matching Placebo
11370360|NCT00447421|BG000|Baseline|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
11370361|NCT00447421|FG000|Participant Flow|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
11370362|NCT00447421|OG000|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
11370363|NCT00447421|EG000|Reported Event|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
11370364|NCT00441272|BG000|Baseline|Placebo|Those participants receiving placebo for 48 weeks
11370365|NCT00441272|BG001|Baseline|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
11370366|NCT00441272|BG002|Baseline|Total|Total of all reporting groups
11370367|NCT00441272|FG000|Participant Flow|Placebo|Those participants receiving placebo for 48 weeks
11370368|NCT00441272|FG001|Participant Flow|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
11370369|NCT00441272|OG000|Outcome|Placebo|Those participants receiving placebo for 48 weeks
11370370|NCT00441272|OG001|Outcome|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
11370371|NCT00441272|EG000|Reported Event|Placebo|Those participants receiving placebo for 48 weeks
11370372|NCT00441272|EG001|Reported Event|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
11370373|NCT00437398|BG000|Baseline|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
11189886|NCT02122146|FG002|Participant Flow|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189887|NCT02122146|FG003|Participant Flow|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189888|NCT02122146|FG004|Participant Flow|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370374|NCT00437398|FG000|Participant Flow|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
11370375|NCT00437398|OG000|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
11370376|NCT00437398|EG000|Reported Event|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
11370377|NCT00440271|BG000|Baseline|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
11370378|NCT00440271|BG001|Baseline|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
11370379|NCT00440271|BG002|Baseline|Total|Total of all reporting groups
11370380|NCT00440271|FG000|Participant Flow|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
11370381|NCT00440271|FG001|Participant Flow|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
11370382|NCT00440271|OG000|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
11370383|NCT00440271|OG001|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
11370384|NCT00440271|EG000|Reported Event|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
11370385|NCT00440271|EG001|Reported Event|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
11370386|NCT00442260|BG000|Baseline|Abraxane Dose Escalation + Fixed Dose DOXIL|"Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.~DOXIL~Abraxane"
11370387|NCT00442260|FG000|Participant Flow|Abraxane Dose Escalation + Fixed Dose DOXIL|"Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.~DOXIL~Abraxane"
11370388|NCT00442260|OG000|Outcome|Abraxane Dose Escalation + Fixed Dose DOXIL|"Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.~DOXIL~Abraxane"
11370389|NCT00442260|EG000|Reported Event|Abraxane Dose Escalation + Fixed Dose DOXIL|"Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.~DOXIL~Abraxane"
11370390|NCT00429026|BG000|Baseline|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
11370391|NCT00429026|FG000|Participant Flow|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
11370392|NCT00429026|OG000|Outcome|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
11370393|NCT00429026|EG000|Reported Event|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
11376312|NCT00662792|FG001|Participant Flow|Tio18GEL/ T18GEL+S_DPI/ T+S_PE/ Salm50DPI|"Period 1: 18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening.~Period 2:~18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning.~Period 3: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening.~Period 4: One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID), in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods."
11376313|NCT00662792|FG002|Participant Flow|Salm50DPI/ T+S_PE/ T18GEL+S_DPI/ Tio18GEL|"Period 1: One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID), in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning.~Period 2: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening.~Period 3: 18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning.~Period 4: 18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods."
11376314|NCT00662792|FG003|Participant Flow|T18GEL+S_DPI/ Salm50DPI/ Tio18GEL/ T+S_PE|Period 1: 18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning. Period 2: One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID), in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning. Period 3: 18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Period 4: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376315|NCT00662792|OG000|Outcome|7.5 µg /25 µg Tio /Salmeterol (T+S_PE)|Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376316|NCT00662792|OG001|Outcome|18 µg Tiotropium (Tio18GEL)|18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376317|NCT00662792|OG002|Outcome|50 µg Salmeterol MDPI (Salm50DPI)|One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376318|NCT00662792|OG003|Outcome|18 µg Tiotropium Free Combination (T18GEL+S_DPI)|18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11189889|NCT02122146|FG005|Participant Flow|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370394|NCT00428207|BG000|Baseline|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
11370395|NCT00428207|FG000|Participant Flow|Insulin Lispro|"Subjects will be randomly assigned to one of the two insulins (insulin Lispro) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
11370396|NCT00428207|FG001|Participant Flow|Insulin Aspart|"Subjects will be randomly assigned to one of the two insulins (insulin Aspart) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
11370397|NCT00428207|OG000|Outcome|Insulin Aspart Versus Insulin Lispro|"Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).~Insulin Aspart versus Insulin Lispro: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients."
11370398|NCT00428207|OG001|Outcome|Insulin Lispro Versus Insulin Aspart|"Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).~Insulin Lispro versus Insulin Aspart: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients."
11370399|NCT00428207|OG000|Outcome|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
11370400|NCT00428207|EG000|Reported Event|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization."
11370401|NCT00439569|BG000|Baseline|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
11370402|NCT00439569|FG000|Participant Flow|Subjects Enrolled|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1. Two new subjects were then enrolled in Cohort 2.
11370403|NCT00439569|OG000|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
11370404|NCT00439569|EG000|Reported Event|Cohorts 1 & 2 (500 mg/kg/Day)|Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
11191733|NCT02133131|EG001|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11370405|NCT00422669|BG000|Baseline|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
11370406|NCT00422669|BG001|Baseline|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
11370407|NCT00422669|BG002|Baseline|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
11370408|NCT00422669|BG003|Baseline|Total|Total of all reporting groups
11370409|NCT00422669|FG000|Participant Flow|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
11370410|NCT00422669|FG001|Participant Flow|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
11370411|NCT00422669|FG002|Participant Flow|Not Randomized|7 of the 205 subjects did not meet inclusion/exclusion criteria.
11370412|NCT00422669|OG000|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
11370413|NCT00422669|OG001|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
11370414|NCT00422669|OG002|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
11370415|NCT00422669|EG000|Reported Event|Subjects With Implant|All 198 subjects with implant were included in this group.
11370416|NCT00432445|BG000|Baseline|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
11370417|NCT00432445|FG000|Participant Flow|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
11370418|NCT00432445|OG000|Outcome|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
11370419|NCT00432445|EG000|Reported Event|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
11370420|NCT00434590|BG000|Baseline|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
11370421|NCT00434590|BG001|Baseline|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
11370422|NCT00434590|BG002|Baseline|Total|Total of all reporting groups
11370423|NCT00434590|FG000|Participant Flow|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
11370424|NCT00434590|FG001|Participant Flow|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
11370425|NCT00434590|OG000|Outcome|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
11370426|NCT00434590|OG001|Outcome|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
11370427|NCT00434590|EG000|Reported Event|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
11370428|NCT00434590|EG001|Reported Event|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
11370429|NCT00424645|BG000|Baseline|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
11370430|NCT00424645|BG001|Baseline|Placebo|Placebo administered IV following Voraxaze arm.
11370431|NCT00424645|BG002|Baseline|Total|Total of all reporting groups
11370432|NCT00424645|FG000|Participant Flow|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
11370433|NCT00424645|FG001|Participant Flow|Placebo|Placebo administered IV following Voraxaze arm.
11370434|NCT00424645|OG000|Outcome|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
11370435|NCT00424645|OG001|Outcome|Placebo|Placebo administered IV following Voraxaze arm.
11370436|NCT00424645|EG000|Reported Event|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
11370437|NCT00424645|EG001|Reported Event|Placebo|Placebo administered IV following Voraxaze arm.
11370438|NCT00430027|BG000|Baseline|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
11370439|NCT00430027|FG000|Participant Flow|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
11370440|NCT00430027|OG000|Outcome|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
11370441|NCT00430027|EG000|Reported Event|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
11370442|NCT00429858|BG000|Baseline|Targeted Therapy Group|"Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1.~S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)~Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle"
11370443|NCT00429858|FG000|Participant Flow|Targeted Therapy Group|"Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1~S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)~Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle"
11370444|NCT00429858|OG000|Outcome|Targeted Therapy Group|"Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1.~S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)~Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle"
11370445|NCT00429858|OG000|Outcome|Targeted Therapy Group|"Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1~S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)~Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle"
11370446|NCT00429858|EG000|Reported Event|Targeted Therapy Group|"Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1.~S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)~Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle"
11370447|NCT00425438|BG000|Baseline|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370448|NCT00425438|BG001|Baseline|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370449|NCT00425438|BG002|Baseline|Total|Total of all reporting groups
11370450|NCT00425438|FG000|Participant Flow|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370451|NCT00425438|FG001|Participant Flow|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370452|NCT00425438|OG000|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370453|NCT00425438|OG001|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370454|NCT00425438|EG000|Reported Event|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370455|NCT00425438|EG001|Reported Event|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
11370456|NCT00421954|BG000|Baseline|Ziprasidone|Ziprasidone: subjects will use ziprasidone
11370457|NCT00421954|FG000|Participant Flow|Ziprasidone|Ziprasidone: subjects will use ziprasidone
11370458|NCT00421954|OG000|Outcome|Ziprasidone|Ziprasidone: subjects will use ziprasidone
11189890|NCT02122146|FG006|Participant Flow|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370459|NCT00421954|EG000|Reported Event|Ziprasidone|Ziprasidone: subjects will use ziprasidone
11370460|NCT00422942|BG000|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
11370461|NCT00422942|FG000|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or as needed (PRN) if retreatment criteria were not met; premedication with methylprednisolone (MP) 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg per week (mg/week; oral or parenteral) for up to 48 weeks and folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
11370462|NCT00422942|OG000|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
11370463|NCT00422942|EG000|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
11370464|NCT00409344|BG000|Baseline|Saline|This group will recive saline
11370465|NCT00409344|BG001|Baseline|Dexmedetomidine|This group will receive dexmedetomidine
11370466|NCT00409344|BG002|Baseline|Total|Total of all reporting groups
11370467|NCT00409344|FG000|Participant Flow|Saline|This group will recive saline
11370468|NCT00409344|FG001|Participant Flow|Dexmedetomidine|This group will receive dexmedetomidine
11370469|NCT00409344|OG000|Outcome|Saline|This group will recive saline
11370470|NCT00409344|OG001|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
11370471|NCT00409344|EG000|Reported Event|Saline|This group will recive saline
11370472|NCT00409344|EG001|Reported Event|Dexmedetomidine|This group will receive dexmedetomidine
11370473|NCT00414453|BG000|Baseline|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
11191734|NCT02133131|EG002|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
11191735|NCT02133131|EG003|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11370474|NCT00414453|FG000|Participant Flow|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
11370475|NCT00414453|OG000|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
11370476|NCT00414453|OG001|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
11370477|NCT00414453|OG002|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
11370478|NCT00414453|OG003|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
11370479|NCT00414453|EG000|Reported Event|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
11370480|NCT00414453|EG001|Reported Event|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
11370481|NCT00414453|EG002|Reported Event|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
11370482|NCT00414453|EG003|Reported Event|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
11370483|NCT00417248|BG000|Baseline|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
11370484|NCT00417248|FG000|Participant Flow|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
11370485|NCT00417248|OG000|Outcome|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
11370486|NCT00417248|OG000|Outcome|Investigational Treatment|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
11370487|NCT00417248|EG000|Reported Event|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
11370488|NCT00418145|BG000|Baseline|Total Study Participants|Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
11370489|NCT00418145|FG000|Participant Flow|Total Study Participants|Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
11370490|NCT00418145|OG000|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
11370491|NCT00418145|OG001|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
11370492|NCT00418145|EG000|Reported Event|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
11191736|NCT02133131|EG004|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
11370493|NCT00418145|EG001|Reported Event|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
11370494|NCT00409331|BG000|Baseline|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
11370495|NCT00409331|FG000|Participant Flow|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
11370496|NCT00409331|OG000|Outcome|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
11370497|NCT00409331|EG000|Reported Event|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
11370498|NCT00392860|BG000|Baseline|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
11370499|NCT00392860|BG001|Baseline|Control Group|Participants will be given a new standard handrim.
11370500|NCT00392860|BG002|Baseline|Total|Total of all reporting groups
11370501|NCT00392860|FG000|Participant Flow|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.~Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.~Natural-Fit : Ergonomic handrim for wheelchairs"
11370502|NCT00392860|FG001|Participant Flow|PalmRim Experiment|"Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.~Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations."
11370503|NCT00392860|FG002|Participant Flow|Handrim Control Group|Participants will be given a new standard handrim.
11370504|NCT00392860|OG000|Outcome|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
11370505|NCT00392860|OG001|Outcome|Handrim Control Group|Participants will be given a new standard handrim.
11370506|NCT00392860|EG000|Reported Event|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
11370507|NCT00392860|EG001|Reported Event|Control Group|Participants will be given a new standard handrim.
11370508|NCT00391430|BG000|Baseline|Control|Participants assigned to the control condition will receive no treatment
11370509|NCT00391430|BG001|Baseline|Sertraline|"Participants will receive treatment with sertraline~Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"
11370510|NCT00391430|BG002|Baseline|Cognitive Behavioral Therapy|"Participants will receive cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."
11370511|NCT00391430|BG003|Baseline|Total|Total of all reporting groups
11370512|NCT00391430|FG000|Participant Flow|Sertraline|"Participants will receive treatment with sertraline~Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"
11370513|NCT00391430|FG001|Participant Flow|Control|Participants assigned to the control condition will receive no treatment
11370514|NCT00391430|FG002|Participant Flow|Cognitive Behavioral Therapy|"Participants will receive cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."
11370515|NCT00391430|OG000|Outcome|Control|Participants assigned to the control condition will receive no treatment
11370516|NCT00391430|OG001|Outcome|Sertraline|"Participants will receive treatment with sertraline~Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"
11370517|NCT00391430|OG002|Outcome|Cognitive Behavioral Therapy|"Participants will receive cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."
11370518|NCT00391430|EG000|Reported Event|Sertraline|"Participants will receive treatment with sertraline~Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"
11370519|NCT00391430|EG001|Reported Event|Control|Participants assigned to the control condition will receive no treatment
11370520|NCT00391430|EG002|Reported Event|Cognitive Behavioral Therapy|"Participants will receive cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."
11370521|NCT00399841|BG000|Baseline|Baseline|Enrolled subjects
11370522|NCT00399841|FG000|Participant Flow|Study|"Stimulation at T7 followed by T8 or stimulation at T8 followed by T7 during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370523|NCT00399841|FG001|Participant Flow|Stimulation at T7 Followed by T8|"Stimulation at T7 followed by T8 during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370524|NCT00399841|FG002|Participant Flow|Stimulation at T8 Followed by T7|"Stimulation at T8 followed by T7 during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370525|NCT00399841|OG000|Outcome|Stimulation at T7|"Stimulation will occur at the T7 during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370526|NCT00399841|OG001|Outcome|Stimulation at T8|"Stimulation will occur at the T8 level during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370527|NCT00399841|EG000|Reported Event|Study|"Stimulation will occur at T7 followed by T8 or T8 followed by T7 during the trial implant period~Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on."
11370528|NCT00387673|BG000|Baseline|Effect of Prolonged Electrical Stimulation on Neural Plastici|
11370529|NCT00387673|FG000|Participant Flow|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370530|NCT00387673|FG001|Participant Flow|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370531|NCT00387673|FG002|Participant Flow|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370532|NCT00387673|OG000|Outcome|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370533|NCT00387673|OG001|Outcome|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370534|NCT00387673|OG002|Outcome|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
11370535|NCT00387673|EG000|Reported Event|Project Closed|
11370536|NCT00386724|BG000|Baseline|Precision Spinal Cord Stimulation|"Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead~Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.~Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System."
11370537|NCT00386724|FG000|Participant Flow|Precision Spinal Cord Stimulation|"Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead~Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.~Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System."
11370538|NCT00386724|OG000|Outcome|Precision Spinal Cord Stimulation|"Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead~Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.~Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System."
11370539|NCT00386724|EG000|Reported Event|Precision Spinal Cord Stimulation|"Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead~Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.~Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System."
11370540|NCT00387244|BG000|Baseline|Precision for Spinal Cord Stimulation|"Single arm Precision for Spinal Cord Stimulation~Precision for Spinal Cord Stimulation: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain."
11370541|NCT00387244|FG000|Participant Flow|Precision for Spinal Cord Stimulation|"Single arm Precision for Spinal Cord Stimulation~Precision for Spinal Cord Stimulation: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain."
11370542|NCT00387244|OG000|Outcome|Precision for Spinal Cord Stimulation|"Single arm Precision for Spinal Cord Stimulation~Precision for Spinal Cord Stimulation: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain."
11370543|NCT00387244|EG000|Reported Event|Precision for Spinal Cord Stimulation|"Single arm Precision for Spinal Cord Stimulation~Precision for Spinal Cord Stimulation: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain."
11370544|NCT00384293|BG000|Baseline|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
11370545|NCT00384293|BG001|Baseline|Placebo (Postrandomization Period)|Patients who were randomized to placebo
11370546|NCT00384293|BG002|Baseline|Total|Total of all reporting groups
11370547|NCT00384293|FG000|Participant Flow|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
11370548|NCT00384293|FG001|Participant Flow|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
11370549|NCT00384293|FG002|Participant Flow|Placebo (Postrandomization Period)|Patients who were randomized to placebo
11370550|NCT00384293|OG000|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
11370551|NCT00384293|OG001|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
11370552|NCT00384293|OG002|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
11370553|NCT00384293|EG000|Reported Event|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
11370554|NCT00384293|EG001|Reported Event|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
11370555|NCT00384293|EG002|Reported Event|Placebo (Postrandomization Period)|Patients who were randomized to placebo
11370556|NCT00383630|BG000|Baseline|Study Subjects|Total number of subjects in the study; breakdown of the number per arm is not available.
11370557|NCT00383630|FG000|Participant Flow|Study Subjects|Total number of subjects in the study; breakdown of the number per arm is not available.
11370558|NCT00383630|OG000|Outcome|Study Subjects|Total number of subjects in the study; breakdown of the number per arm is not available.
11370559|NCT00383630|EG000|Reported Event|Study Subjects|Total number of subjects in the study; breakdown of the number per arm is not available.
11370560|NCT00374543|BG000|Baseline|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370561|NCT00374543|BG001|Baseline|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370562|NCT00374543|BG002|Baseline|Total|Total of all reporting groups
11370563|NCT00374543|FG000|Participant Flow|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370564|NCT00374543|FG001|Participant Flow|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370565|NCT00374543|OG000|Outcome|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370566|NCT00374543|OG001|Outcome|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370567|NCT00374543|EG000|Reported Event|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370568|NCT00374543|EG001|Reported Event|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
11370569|NCT00377455|BG000|Baseline|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
11370570|NCT00377455|FG000|Participant Flow|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
11370571|NCT00377455|OG000|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
11370572|NCT00377455|EG000|Reported Event|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
11370573|NCT00371462|BG000|Baseline|Arm 1|"MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);~Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months."
11370574|NCT00371462|BG001|Baseline|Arm 2|"MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)~MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months."
11370575|NCT00371462|BG002|Baseline|Total|Total of all reporting groups
11370576|NCT00371462|FG000|Participant Flow|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
11370577|NCT00371462|FG001|Participant Flow|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
11370578|NCT00371462|OG000|Outcome|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
11370579|NCT00371462|OG001|Outcome|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
11370580|NCT00371462|EG000|Reported Event|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
11370581|NCT00371462|EG001|Reported Event|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
11370582|NCT00369265|BG000|Baseline|Sugar Pill|Placebo for Lansoprazole twice daily
11370583|NCT00369265|BG001|Baseline|Lansoprazole|Lansoprazole 30 mg twice daily
11370584|NCT00369265|BG002|Baseline|Total|Total of all reporting groups
11370585|NCT00369265|FG000|Participant Flow|Sugar Pill|Placebo for Lansoprazole twice daily
11191737|NCT02133131|EG005|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370586|NCT00369265|FG001|Participant Flow|Lansoprazole|Lansoprazole 30 mg twice daily
11370587|NCT00369265|OG000|Outcome|Sugar Pill|Placebo for Lansoprazole twice daily
11370588|NCT00369265|OG001|Outcome|Lansoprazole|Lansoprazole 30 mg twice daily
11370589|NCT00369265|EG000|Reported Event|Sugar Pill|Placebo for Lansoprazole twice daily
11370590|NCT00369265|EG001|Reported Event|Lansoprazole|Lansoprazole 30 mg twice daily
11370591|NCT00370695|BG000|Baseline|Precision Spinal Cord Stimulation System|"Single arm Precision Spinal Cord Stimulation System.~Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study"
11370592|NCT00370695|FG000|Participant Flow|Precision Spinal Cord Stimulation System|"Single arm Precision Spinal Cord Stimulation System.~Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study"
11370593|NCT00370695|OG000|Outcome|Precision Spinal Cord Stimulation System|"Single arm Precision Spinal Cord Stimulation System.~Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study"
11370594|NCT00370695|EG000|Reported Event|Precision Spinal Cord Stimulation System|"Single arm Precision Spinal Cord Stimulation System.~Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study"
11370595|NCT00364689|BG000|Baseline|Lactulose Given With a Placebo (Sugar Pill)|"Lactulose~Placebo"
11370596|NCT00364689|BG001|Baseline|Lactulose Given With Rifaximin|"Rifaximin~Lactulose"
11370597|NCT00364689|BG002|Baseline|Rifaximin Given Alone|Rifaximin
11370598|NCT00364689|BG003|Baseline|Total|Total of all reporting groups
11370599|NCT00364689|FG000|Participant Flow|All Participants|
11370600|NCT00364689|OG000|Outcome|Lactulose Given With a Placebo (Sugar Pill)|"Lactulose~Placebo"
11370601|NCT00364689|OG001|Outcome|Lactulose Given With Rifaximin|"Rifaximin~Lactulose"
11370602|NCT00364689|OG002|Outcome|Rifaximin Given Alone|Rifaximin
11370603|NCT00364689|EG000|Reported Event|All Study Participants|All study participants enrolled in this study.
11370604|NCT00352118|BG000|Baseline|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
11370605|NCT00352118|FG000|Participant Flow|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
11370606|NCT00352118|OG000|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
11370607|NCT00352118|EG000|Reported Event|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
11370608|NCT00368654|BG000|Baseline|A-Monotherapy With Raptiva Alone|"Monotherapy with Raptiva alone~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370609|NCT00368654|BG001|Baseline|B-Combination Therapy With Both Raptiva and Methotrexate|"Combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370610|NCT00368654|BG002|Baseline|C-Continue Raptiva, Discontinue Methotrexate|"Continue Raptiva, discontinue methotrexate~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370611|NCT00368654|BG003|Baseline|D-Continue Combination Therapy With Both Raptiva and Methotrex|"Continue combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370612|NCT00368654|BG004|Baseline|Total|Total of all reporting groups
11370613|NCT00368654|FG000|Participant Flow|A-Monotherapy With Raptiva Alone|"Monotherapy with Raptiva alone~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370614|NCT00368654|FG001|Participant Flow|B-Combination Therapy With Both Raptiva and Methotrexate|"Combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370615|NCT00368654|FG002|Participant Flow|C-Continue Raptiva, Discontinue Methotrexate|"Continue Raptiva, discontinue methotrexate~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370616|NCT00368654|FG003|Participant Flow|D-Continue Combination Therapy With Both Raptiva and Methotrex|"Continue combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370617|NCT00368654|OG000|Outcome|A-Monotherapy With Raptiva Alone|"Monotherapy with Raptiva alone~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370618|NCT00368654|OG001|Outcome|B-Combination Therapy With Both Raptiva and Methotrexate|"Combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370619|NCT00368654|OG002|Outcome|C-Continue Raptiva, Discontinue Methotrexate|"Continue Raptiva, discontinue methotrexate~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370620|NCT00368654|OG003|Outcome|D-Continue Combination Therapy With Both Raptiva and Methotrex|"Continue combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370621|NCT00368654|EG000|Reported Event|A-Monotherapy With Raptiva Alone|"Monotherapy with Raptiva alone~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370622|NCT00368654|EG001|Reported Event|B-Combination Therapy With Both Raptiva and Methotrexate|"Combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370623|NCT00368654|EG002|Reported Event|C-Continue Raptiva, Discontinue Methotrexate|"Continue Raptiva, discontinue methotrexate~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370624|NCT00368654|EG003|Reported Event|D-Continue Combination Therapy With Both Raptiva and Methotrex|"Continue combination therapy with both Raptiva and Methotrexate~Methotrexate: Initial dose 5 mg, then 15 mg per week~Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg"
11370625|NCT00356421|BG000|Baseline|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
11370626|NCT00356421|BG001|Baseline|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
11370627|NCT00356421|BG002|Baseline|Total|Total of all reporting groups
11370628|NCT00356421|FG000|Participant Flow|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
11370629|NCT00356421|FG001|Participant Flow|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
11370630|NCT00356421|OG000|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
11370631|NCT00356421|OG001|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
11370632|NCT00356421|EG000|Reported Event|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
11370633|NCT00356421|EG001|Reported Event|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
11370634|NCT00350623|BG000|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370635|NCT00350623|BG001|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370636|NCT00350623|BG002|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370637|NCT00350623|BG003|Baseline|Total|Total of all reporting groups
11370638|NCT00350623|FG000|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370639|NCT00350623|FG001|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370640|NCT00350623|FG002|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370641|NCT00350623|OG000|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370642|NCT00350623|OG001|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370643|NCT00350623|OG002|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370644|NCT00350623|EG000|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370645|NCT00350623|EG001|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370646|NCT00350623|EG002|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
11370647|NCT00356187|BG000|Baseline|Propranol Treatment|Propranolol
11370648|NCT00356187|BG001|Baseline|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
11370649|NCT00356187|BG002|Baseline|Total|Total of all reporting groups
11370650|NCT00356187|FG000|Participant Flow|Propranol Treatment|Propranolol
11370651|NCT00356187|FG001|Participant Flow|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
11370652|NCT00356187|OG000|Outcome|Propranol Treatment|Propranolol
11370653|NCT00356187|OG001|Outcome|Standard of Care|Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.
11370654|NCT00356187|OG001|Outcome|Standard of Care|
11370655|NCT00356187|OG001|Outcome|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
11370656|NCT00356187|EG000|Reported Event|Propranol Treatment|Propranolol
11370657|NCT00356187|EG001|Reported Event|Standard of Care|Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.
11370658|NCT00353275|BG000|Baseline|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
11370659|NCT00353275|BG001|Baseline|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
11370660|NCT00353275|BG002|Baseline|Total|Total of all reporting groups
11370661|NCT00353275|FG000|Participant Flow|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
11370662|NCT00353275|FG001|Participant Flow|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
11370663|NCT00353275|OG000|Outcome|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
11370664|NCT00353275|OG001|Outcome|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
11370665|NCT00353275|EG000|Reported Event|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
11191738|NCT02133131|EG006|Reported Event|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
11370666|NCT00353275|EG001|Reported Event|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
11370667|NCT00350844|BG000|Baseline|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
11370668|NCT00350844|FG000|Participant Flow|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
11370669|NCT00350844|OG000|Outcome|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
11370670|NCT00350844|EG000|Reported Event|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
11370671|NCT00348556|BG000|Baseline|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
11370672|NCT00348556|FG000|Participant Flow|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
11370673|NCT00348556|OG000|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
11370674|NCT00348556|EG000|Reported Event|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
11370675|NCT00319839|BG000|Baseline|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
11370676|NCT00319839|FG000|Participant Flow|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
11370677|NCT00319839|OG000|Outcome|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
11370678|NCT00319839|EG000|Reported Event|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
11370679|NCT00344019|BG000|Baseline|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
11370680|NCT00344019|BG001|Baseline|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
11370681|NCT00344019|BG002|Baseline|Screening|# patients who signed consent form prior to angiography. 74 did not continue, 23 completed the study. It is believed that most of the 74 did not continue due to the fact that no PCI was indicated at time of angiography
11370682|NCT00344019|BG003|Baseline|Total|Total of all reporting groups
11370683|NCT00344019|FG000|Participant Flow|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
11370684|NCT00344019|FG001|Participant Flow|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
11370685|NCT00344019|FG002|Participant Flow|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
11370686|NCT00344019|OG000|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
11370687|NCT00344019|OG001|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
11370688|NCT00344019|OG000|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI~Screening: Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)"
11370689|NCT00344019|OG001|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS~Screening: Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)"
11370690|NCT00344019|OG002|Outcome|Screening|Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail
11370691|NCT00344019|OG002|Outcome|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
11370692|NCT00344019|EG000|Reported Event|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
11370693|NCT00344019|EG001|Reported Event|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
11189891|NCT02122146|FG007|Participant Flow|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189892|NCT02122146|OG000|Outcome|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
11370694|NCT00344019|EG002|Reported Event|Screening|97 patients screened 23 patients completed study in 1:1 randomization scheme. Randomization assignment not known. Data no longer available. No data analyzed
11370695|NCT00338455|BG000|Baseline|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370696|NCT00338455|BG001|Baseline|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370697|NCT00338455|BG002|Baseline|Total|Total of all reporting groups
11370698|NCT00338455|FG000|Participant Flow|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370699|NCT00338455|FG001|Participant Flow|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370700|NCT00338455|OG000|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370701|NCT00338455|OG001|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370702|NCT00338455|EG000|Reported Event|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370703|NCT00338455|EG001|Reported Event|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
11370704|NCT00329108|BG000|Baseline|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
11370705|NCT00329108|BG001|Baseline|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
11370706|NCT00329108|BG002|Baseline|Total|Total of all reporting groups
11370707|NCT00329108|FG000|Participant Flow|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
11370708|NCT00329108|FG001|Participant Flow|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
11370709|NCT00329108|OG000|Outcome|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
11370710|NCT00329108|OG001|Outcome|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
11370711|NCT00329108|EG000|Reported Event|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
11370712|NCT00329108|EG001|Reported Event|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
11370713|NCT00325572|BG000|Baseline|Zinc and Vitamin C Supplementation|Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks
11370714|NCT00325572|BG001|Baseline|Placebo Group|Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
11370715|NCT00325572|BG002|Baseline|Total|Total of all reporting groups
11370716|NCT00325572|FG000|Participant Flow|Zinc and Vitamin C Supplementation|Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks
11370717|NCT00325572|FG001|Participant Flow|Placebo Group|Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
11370718|NCT00325572|OG000|Outcome|Zinc and Vitamin C Supplementation|Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks
11370719|NCT00325572|OG001|Outcome|Placebo Group|Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
11370720|NCT00325572|EG000|Reported Event|Zinc and Vitamin C Supplementation|Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks
11370721|NCT00325572|EG001|Reported Event|Placebo Group|Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
11370722|NCT00333762|BG000|Baseline|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
11370723|NCT00333762|FG000|Participant Flow|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
11370724|NCT00333762|OG000|Outcome|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
11370725|NCT00333762|EG000|Reported Event|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
11191739|NCT02133235|BG000|Baseline|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
11370726|NCT00333229|BG000|Baseline|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370727|NCT00333229|BG001|Baseline|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370728|NCT00333229|BG002|Baseline|Total|Total of all reporting groups
11370729|NCT00333229|FG000|Participant Flow|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370730|NCT00333229|FG001|Participant Flow|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370731|NCT00333229|OG000|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370732|NCT00333229|OG001|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370733|NCT00333229|EG000|Reported Event|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370734|NCT00333229|EG001|Reported Event|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
11370735|NCT00322855|BG000|Baseline|Chart Review|patients diagnosed with soft tissue sarcoma
11370736|NCT00322855|FG000|Participant Flow|Chart Review|patients diagnosed with soft tissue sarcoma
11370737|NCT00322855|OG000|Outcome|Chart Review|patients diagnosed with soft tissue sarcoma
11370738|NCT00322855|EG000|Reported Event|Chart Review|patients diagnosed with soft tissue sarcoma
11370739|NCT00323635|BG000|Baseline|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
11370740|NCT00323635|BG001|Baseline|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
11370741|NCT00323635|BG002|Baseline|Total|Total of all reporting groups
11370742|NCT00323635|FG000|Participant Flow|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
11370743|NCT00323635|FG001|Participant Flow|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
11370744|NCT00323635|OG000|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
11370745|NCT00323635|OG001|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
11370746|NCT00323635|OG000|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
11370747|NCT00323635|OG001|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
11370748|NCT00323635|EG000|Reported Event|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
11370749|NCT00323635|EG001|Reported Event|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
11370750|NCT00329732|BG000|Baseline|Lidocaine/Bupivicaine|
11370751|NCT00329732|BG001|Baseline|Saline (Placebo)|
11370752|NCT00329732|BG002|Baseline|Total|Total of all reporting groups
11370753|NCT00329732|FG000|Participant Flow|Lidocaine/Bupivicaine|
11370754|NCT00329732|FG001|Participant Flow|Saline (Placebo)|
11370755|NCT00329732|OG000|Outcome|Lidocaine/Bupivicaine|
11370756|NCT00329732|EG000|Reported Event|Lidocaine/Bupivicaine|
11189893|NCT02122146|OG001|Outcome|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189894|NCT02122146|OG002|Outcome|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189895|NCT02122146|OG003|Outcome|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189896|NCT02122146|OG004|Outcome|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189897|NCT02122146|OG005|Outcome|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370757|NCT00329732|EG001|Reported Event|Saline (Placebo)|
11370758|NCT00320931|BG000|Baseline|Subjects Undergoing Imaging Studies|
11370759|NCT00320931|FG000|Participant Flow|Hybrid PET/CT|The participants underwent rest and vasodilator rubidium PET and CT angiography studies using standard doses for clinically indicated studies
11370760|NCT00320931|OG000|Outcome|Subjects Undergoing Imaging Studies|
11370761|NCT00320931|EG000|Reported Event|Subjects Undergoing Imaging Studies|
11370762|NCT00314353|BG000|Baseline|Capecitabine, Oxaliplatin, Bevacizumab|
11370763|NCT00314353|BG001|Baseline|Capecitabine, Irinotecan, Bevacizumab|
11370764|NCT00314353|BG002|Baseline|Total|Total of all reporting groups
11370765|NCT00314353|FG000|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab|
11370766|NCT00314353|FG001|Participant Flow|Capecitabine, Irinotecan, Bevacizumab|
11370767|NCT00314353|OG000|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
11370768|NCT00314353|OG001|Outcome|Capecitabine, Irinotecan, Bevacizumab|
11370769|NCT00314353|EG000|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab|
11370770|NCT00314353|EG001|Reported Event|Capecitabine, Irinotecan, Bevacizumab|
11370771|NCT00314093|BG000|Baseline|Data Not Able to be Obtained|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
11370772|NCT00314093|FG000|Participant Flow|No Study Data Available|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed. No study data are available
11370773|NCT00314093|OG000|Outcome|Data Not Able to be Obtained|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
11370774|NCT00314093|EG000|Reported Event|Data Not Able to be Obtained|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
11370775|NCT00314327|BG000|Baseline|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
11370776|NCT00314327|FG000|Participant Flow|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
11370777|NCT00314327|OG000|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
11370778|NCT00314327|EG000|Reported Event|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
11370779|NCT00308113|BG000|Baseline|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
11370780|NCT00308113|BG001|Baseline|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
11370781|NCT00308113|BG002|Baseline|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
11370782|NCT00308113|BG003|Baseline|Enhanced Standard of Care|Enhanced standard of care.
11370783|NCT00308113|BG004|Baseline|Total|Total of all reporting groups
11370784|NCT00308113|FG000|Participant Flow|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
11370785|NCT00308113|FG001|Participant Flow|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
11370786|NCT00308113|FG002|Participant Flow|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
11370787|NCT00308113|FG003|Participant Flow|Enhanced Standard of Care|Enhanced standard of care.
11189898|NCT02122146|OG006|Outcome|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370788|NCT00308113|OG000|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
11370789|NCT00308113|OG001|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
11370790|NCT00308113|OG002|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
11370791|NCT00308113|OG003|Outcome|Enhanced Standard of Care|Enhanced standard of care.
11370792|NCT00308113|EG000|Reported Event|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
11370793|NCT00308113|EG001|Reported Event|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
11370794|NCT00308113|EG002|Reported Event|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
11370795|NCT00308113|EG003|Reported Event|Enhanced Standard of Care|Enhanced standard of care.
11370796|NCT00305643|BG000|Baseline|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370797|NCT00305643|BG001|Baseline|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370798|NCT00305643|BG002|Baseline|Total|Total of all reporting groups
11370799|NCT00305643|FG000|Participant Flow|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370800|NCT00305643|FG001|Participant Flow|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370801|NCT00305643|OG000|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370802|NCT00305643|OG001|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370803|NCT00305643|OG001|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370804|NCT00305643|EG000|Reported Event|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370805|NCT00305643|EG001|Reported Event|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
11370806|NCT00298740|BG000|Baseline|Aventis U-400 Insulin|Aventis U-400 Insulin
11370807|NCT00298740|FG000|Participant Flow|Aventis U-400 Insulin|Aventis U-400 Insulin
11370808|NCT00298740|OG000|Outcome|Aventis U-400 Insulin|Aventis U-400 Insulin
11370809|NCT00298740|EG000|Reported Event|Aventis U-400 Insulin|Aventis U-400 Insulin
11370810|NCT00301080|BG000|Baseline|All Participants (Original Version)|All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
11370811|NCT00301080|FG000|Participant Flow|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
11370812|NCT00301080|FG001|Participant Flow|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
11370813|NCT00301080|FG002|Participant Flow|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
11370814|NCT00301080|FG003|Participant Flow|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
11370815|NCT00301080|FG004|Participant Flow|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 12 weeks.
11370816|NCT00301080|OG000|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
11370817|NCT00301080|OG001|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
11370818|NCT00301080|OG002|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
11370819|NCT00301080|OG003|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
11370820|NCT00301080|OG004|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
11370821|NCT00301080|EG000|Reported Event|Placebo (Original Version)|
11370822|NCT00301080|EG001|Reported Event|D-cycloserine 250mg|
11370823|NCT00299195|BG000|Baseline|Cohort 1|"sulindac~sulindac: Sulindac 150 mg po bid x 24 weeks"
11370824|NCT00299195|BG001|Baseline|Cohort 2|"placebo~Placebo: Placebo bid x 24 weeks"
11370825|NCT00299195|BG002|Baseline|Total|Total of all reporting groups
11370826|NCT00299195|FG000|Participant Flow|Cohort 1|"sulindac~sulindac: Sulindac 150 mg po bid x 24 weeks"
11370827|NCT00299195|FG001|Participant Flow|Cohort 2|"placebo~Placebo: Placebo bid x 24 weeks"
11370828|NCT00299195|OG000|Outcome|Cohort 1|"sulindac~sulindac: Sulindac 150 mg po bid x 24 weeks"
11370829|NCT00299195|OG001|Outcome|Cohort 2|"placebo~Placebo: Placebo bid x 24 weeks"
11370830|NCT00299195|EG000|Reported Event|Cohort 1|"sulindac~sulindac: Sulindac 150 mg po bid x 24 weeks"
11370831|NCT00299195|EG001|Reported Event|Cohort 2|"placebo~Placebo: Placebo bid x 24 weeks"
11370832|NCT00290407|BG000|Baseline|RITUXIMAB PLUS ORAL Β-GLUCAN|
11370833|NCT00290407|FG000|Participant Flow|RITUXIMAB PLUS ORAL Β-GLUCAN|
11370834|NCT00290407|OG000|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
11370835|NCT00290407|EG000|Reported Event|RITUXIMAB PLUS ORAL Β-GLUCAN|
11370836|NCT00295490|BG000|Baseline|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
11370837|NCT00295490|BG001|Baseline|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
11370838|NCT00295490|BG002|Baseline|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
11370839|NCT00295490|BG003|Baseline|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
11370840|NCT00295490|BG004|Baseline|Total|Total of all reporting groups
11370841|NCT00295490|FG000|Participant Flow|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
11370842|NCT00295490|FG001|Participant Flow|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
11370843|NCT00295490|FG002|Participant Flow|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
11370844|NCT00295490|FG003|Participant Flow|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
11370845|NCT00295490|OG000|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
11370846|NCT00295490|OG001|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
11370847|NCT00295490|OG002|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
11370848|NCT00295490|OG003|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
11370849|NCT00295490|EG000|Reported Event|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
11370850|NCT00295490|EG001|Reported Event|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
11370851|NCT00295490|EG002|Reported Event|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
11370852|NCT00295490|EG003|Reported Event|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
11370853|NCT00268463|BG000|Baseline|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
11370854|NCT00268463|BG001|Baseline|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
11370855|NCT00268463|BG002|Baseline|Total|Total of all reporting groups
11370856|NCT00268463|FG000|Participant Flow|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
11370857|NCT00268463|FG001|Participant Flow|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
11370858|NCT00268463|OG000|Outcome|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
11370859|NCT00268463|OG001|Outcome|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
11370860|NCT00268463|EG000|Reported Event|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
11370861|NCT00268463|EG001|Reported Event|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
11370862|NCT00271102|BG000|Baseline|Anterior Colporrhaphy|Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
11370863|NCT00271102|BG001|Baseline|Paravaginal Defect Repair|Abdominal paravaginal defect repair cystocele (dropped bladder)
11370864|NCT00271102|BG002|Baseline|Total|Total of all reporting groups
11191740|NCT02133235|BG001|Baseline|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
11370865|NCT00271102|FG000|Participant Flow|Anterior Colporrhaphy|Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
11370866|NCT00271102|FG001|Participant Flow|Paravaginal Defect Repair|Abdominal paravaginal defect repair cystocele (dropped bladder)
11370867|NCT00271102|OG000|Outcome|POP Q Stage|Prolapse stage at followed as measured by the POP-Q system
11370868|NCT00271102|OG000|Outcome|Complications|INtra-op and post-op complications
11370869|NCT00271102|EG000|Reported Event|Anterior Colporrhaphy|Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
11370870|NCT00271102|EG001|Reported Event|Paravaginal Defect Repair|Abdominal paravaginal defect repair cystocele (dropped bladder)
11370871|NCT00276419|BG000|Baseline|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
11370872|NCT00276419|BG001|Baseline|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
11370873|NCT00276419|BG002|Baseline|Total|Total of all reporting groups
11370874|NCT00276419|FG000|Participant Flow|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
11370875|NCT00276419|FG001|Participant Flow|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
11370876|NCT00276419|OG000|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
11370877|NCT00276419|OG001|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
11370878|NCT00276419|EG000|Reported Event|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
11370879|NCT00276419|EG001|Reported Event|Diclofenac|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
11370880|NCT00279409|BG000|Baseline|Aripiprazole|"This treatment arm (also called the combination arm) consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial.~aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370881|NCT00279409|BG001|Baseline|Sugar Pill|"This treatment arm (also called the simple treatment arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis.~Sugar pill: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370882|NCT00279409|BG002|Baseline|Total|Total of all reporting groups
11370883|NCT00279409|FG000|Participant Flow|Aripiprazole|"This treatment arm (also called the combination arm) consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial.~aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370884|NCT00279409|FG001|Participant Flow|Sugar Pill|"This treatment arm (also called the simple treatment arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis.~Sugar pill: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370885|NCT00279409|OG000|Outcome|Aripiprazole|"This treatment arm (also called the combination arm) consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial.~aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370886|NCT00279409|OG001|Outcome|Sugar Pill|"This treatment arm (also called the simple treatment arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis.~Sugar pill: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370887|NCT00279409|EG000|Reported Event|Aripiprazole|"This treatment arm (also called the combination arm) consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial.~aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370888|NCT00279409|EG001|Reported Event|Sugar Pill|"This treatment arm (also called the simple treatment arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis.~Sugar pill: double blind capsules (abilify or placebo) taken once daily, up to 10mg."
11370889|NCT00281879|BG000|Baseline|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
11370890|NCT00281879|BG001|Baseline|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
11370891|NCT00281879|BG002|Baseline|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
11370892|NCT00281879|BG003|Baseline|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
11191741|NCT02133235|BG002|Baseline|Total|Total of all reporting groups
11370893|NCT00281879|BG004|Baseline|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
11370894|NCT00281879|BG005|Baseline|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
11370895|NCT00281879|BG006|Baseline|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
11370896|NCT00281879|BG007|Baseline|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
11370897|NCT00281879|BG008|Baseline|Total|Total of all reporting groups
11370898|NCT00281879|FG000|Participant Flow|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
11370899|NCT00281879|FG001|Participant Flow|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
11370900|NCT00281879|FG002|Participant Flow|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
11370901|NCT00281879|FG003|Participant Flow|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
11370902|NCT00281879|FG004|Participant Flow|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
11370903|NCT00281879|FG005|Participant Flow|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
11189899|NCT02122146|OG007|Outcome|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11370904|NCT00281879|FG006|Participant Flow|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
11370905|NCT00281879|FG007|Participant Flow|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
11370906|NCT00281879|OG000|Outcome|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|
11370907|NCT00281879|OG001|Outcome|Busulfan and Cyclophosphamide (Cytoxan)|
11370908|NCT00281879|OG002|Outcome|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
11370909|NCT00281879|OG003|Outcome|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
11370910|NCT00281879|OG004|Outcome|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
11370911|NCT00281879|OG005|Outcome|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
11370912|NCT00281879|OG006|Outcome|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
11370913|NCT00281879|OG007|Outcome|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
11370914|NCT00281879|EG000|Reported Event|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
11191742|NCT02133235|FG000|Participant Flow|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
11370915|NCT00281879|EG001|Reported Event|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
11370916|NCT00281879|EG002|Reported Event|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
11370917|NCT00281879|EG003|Reported Event|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
11370918|NCT00281879|EG004|Reported Event|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
11370919|NCT00281879|EG005|Reported Event|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
11370920|NCT00281879|EG006|Reported Event|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
11370921|NCT00281879|EG007|Reported Event|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
11370922|NCT00271947|BG000|Baseline|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
11370923|NCT00271947|FG000|Participant Flow|Autologous Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
11370924|NCT00271947|OG000|Outcome|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
11370925|NCT00271947|EG000|Reported Event|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
11370926|NCT00271011|BG000|Baseline|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
11370927|NCT00271011|FG000|Participant Flow|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
11370928|NCT00271011|OG000|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
11370929|NCT00271011|EG000|Reported Event|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
11370930|NCT00253981|BG000|Baseline|Experimental|The experimental group received the monochromatic light infrared energy treatment (MIRE).
11370931|NCT00253981|BG001|Baseline|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
11370932|NCT00253981|BG002|Baseline|Total|Total of all reporting groups
11370933|NCT00253981|FG000|Participant Flow|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
11370934|NCT00253981|FG001|Participant Flow|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
11370935|NCT00253981|OG000|Outcome|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
11370936|NCT00253981|OG001|Outcome|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
11370937|NCT00253981|EG000|Reported Event|Experimental|The experimental group received the monochromatic light infrared red energy treatment (MIRE).
11370938|NCT00253981|EG001|Reported Event|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
11370939|NCT00252174|BG000|Baseline|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11191743|NCT02133235|FG001|Participant Flow|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
11370940|NCT00252174|BG001|Baseline|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
11370941|NCT00252174|BG002|Baseline|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370942|NCT00252174|BG003|Baseline|Total|Total of all reporting groups
11370943|NCT00252174|FG000|Participant Flow|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370944|NCT00252174|FG001|Participant Flow|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
11370945|NCT00252174|FG002|Participant Flow|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370946|NCT00252174|OG000|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11240268|NCT02477553|BG001|Baseline|Quantitative|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Quantitative"
11240269|NCT02477553|BG002|Baseline|Total|Total of all reporting groups
11240270|NCT02477553|FG000|Participant Flow|Verbal|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~Decision Aid (DA) - Verbal"
11240271|NCT02477553|FG001|Participant Flow|Quantitative|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~Decision Aid (DA) - Quantitative"
11240272|NCT02477553|OG000|Outcome|Verbal|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Verbal"
11240273|NCT02477553|OG001|Outcome|Quantitative|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Quantitative"
11240274|NCT02477553|EG000|Reported Event|Quantitative|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Quantitative"
11240275|NCT02477553|EG001|Reported Event|Verbal|"Subjects view:~A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.~Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.~DA - Verbal"
11240276|NCT02477605|BG000|Baseline|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
11240277|NCT02477605|BG001|Baseline|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
11240278|NCT02477605|BG002|Baseline|Total|Total of all reporting groups
11240279|NCT02477605|FG000|Participant Flow|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
11240280|NCT02477605|FG001|Participant Flow|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
11370947|NCT00252174|OG001|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
10850008|NCT00299546|OG000|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
11240281|NCT02477605|OG000|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
11240282|NCT02477605|OG001|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
11370948|NCT00252174|OG002|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370949|NCT00252174|EG000|Reported Event|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370950|NCT00252174|EG001|Reported Event|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
11370951|NCT00252174|EG002|Reported Event|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
11370952|NCT00256295|BG000|Baseline|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
11370953|NCT00256295|FG000|Participant Flow|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
11370954|NCT00256295|OG000|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
11370955|NCT00256295|EG000|Reported Event|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
11370956|NCT00245128|BG000|Baseline|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
11370957|NCT00245128|FG000|Participant Flow|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
11370958|NCT00245128|OG000|Outcome|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
11370959|NCT00245128|EG000|Reported Event|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
11370960|NCT00268450|BG000|Baseline|Study Intervention|"Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.~bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles~cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles~gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles~paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles~cysectomy"
11370961|NCT00268450|FG000|Participant Flow|Study Intervention|"Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.~bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles~cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles~gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles~paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles~cysectomy"
11370962|NCT00268450|OG000|Outcome|Study Intervention|"Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.~bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles~cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles~gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles~paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles~cysectomy"
11240283|NCT02477605|EG000|Reported Event|27-Gauge Treated Eye|Ocular events, treated (study) eye
11370963|NCT00268450|EG000|Reported Event|Study Intervention|"Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.~bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles~cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles~gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles~paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles~cysectomy"
11370964|NCT00239720|BG000|Baseline|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
11370965|NCT00239720|BG001|Baseline|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
11370966|NCT00239720|BG002|Baseline|Total|Total of all reporting groups
11370967|NCT00239720|FG000|Participant Flow|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
11370968|NCT00239720|FG001|Participant Flow|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
11370969|NCT00239720|OG000|Outcome|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
11370970|NCT00239720|OG001|Outcome|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
11370971|NCT00239720|EG000|Reported Event|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
11370972|NCT00239720|EG001|Reported Event|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
11370973|NCT00250718|BG000|Baseline|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
11370974|NCT00250718|FG000|Participant Flow|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
11370975|NCT00250718|OG000|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
11370976|NCT00250718|EG000|Reported Event|Arm 1 Combination Treatment|"VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd~Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.~VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.~Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.~Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.~Levofloxacin: Levofloxacin will be administ"
11370977|NCT00244010|BG000|Baseline|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
11370978|NCT00244010|BG001|Baseline|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
11370979|NCT00244010|BG002|Baseline|Total|Total of all reporting groups
11370980|NCT00244010|FG000|Participant Flow|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
11370981|NCT00244010|FG001|Participant Flow|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
11370982|NCT00244010|OG000|Outcome|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
11370983|NCT00244010|OG001|Outcome|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
11370984|NCT00244010|EG000|Reported Event|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
11370985|NCT00244010|EG001|Reported Event|Donor|Donors were not assessed for adverse events.
11370986|NCT00218036|BG000|Baseline|Modafinil 200mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11370987|NCT00218036|BG001|Baseline|Modafinil 400mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11370988|NCT00218036|BG002|Baseline|Citalopram 20mg/Methadone Maintenance (1.2mg/kg)|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11370989|NCT00218036|BG003|Baseline|Citalopram 40mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
11370990|NCT00218036|BG004|Baseline|Placebo/Methadone Maintenance (1.2mg/kg)|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
11370991|NCT00218036|BG005|Baseline|Total|Total of all reporting groups
11240284|NCT02477605|EG001|Reported Event|27-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
11240285|NCT02477605|EG002|Reported Event|27-Gauge Systemic|Non-ocular adverse events
11370992|NCT00218036|FG000|Participant Flow|Modafinil 200mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11189900|NCT02122146|EG000|Reported Event|PF-06664178 0.15 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
11370993|NCT00218036|FG001|Participant Flow|Modafinil 400mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11370994|NCT00218036|FG002|Participant Flow|Citalopram 20mg/Methadone Maintenance (1.2mg/kg)|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11189901|NCT02122146|EG001|Reported Event|PF-06664178 0.30 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189902|NCT02122146|EG002|Reported Event|PF-06664178 0.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189903|NCT02122146|EG003|Reported Event|PF-06664178 1.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189904|NCT02122146|EG004|Reported Event|PF-06664178 2.40 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189905|NCT02122146|EG005|Reported Event|PF-06664178 3.60 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189906|NCT02122146|EG006|Reported Event|PF-06664178 4.20 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189907|NCT02122146|EG007|Reported Event|PF-06664178 4.80 mg/kg|Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
11189908|NCT02122146|EG008|Reported Event|Total|Treatment Group Description TBD
11189909|NCT02122341|BG000|Baseline|Experimental: Backstop|"Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.~BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F)."
11189910|NCT02122341|BG001|Baseline|No Intervention: Control|Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
11189911|NCT02122341|BG002|Baseline|Total|Total of all reporting groups
11189912|NCT02122341|FG000|Participant Flow|Experimental: BackStop|"Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.~BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F)."
11189913|NCT02122341|FG001|Participant Flow|No Intervention: Control|Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
11189914|NCT02122341|OG000|Outcome|Investigational: BackStop|"Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.~BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F)."
11189915|NCT02122341|OG001|Outcome|No Intervention: Control|Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
11240286|NCT02477605|EG003|Reported Event|23-Gauge Treated Eye|Ocular events, treated (study) eye
11240287|NCT02477605|EG004|Reported Event|23-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
11240288|NCT02477605|EG005|Reported Event|23-Gauge Systemic|Non-ocular adverse events
11240289|NCT02477670|BG000|Baseline|Placebo|Participants were randomized to receive placebo capsules matched to AVP-786 orally twice a day (BID) in Stage 1.
11240290|NCT02477670|BG001|Baseline|AVP-786|Participants were randomized to receive AVP-786 once daily (QD) on Day 1 for the first 7 days in Stage 1. Scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 milligrams twice a day (d6-DM 34 mg/Q 4.9 mg BID).
11240291|NCT02477670|BG002|Baseline|Total|Total of all reporting groups
11240292|NCT02477670|FG000|Participant Flow|Stage 1: AVP-786|Participants were randomized to receive AVP-786 once daily (QD) on Day 1 for the first 7 days. Scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 milligrams twice a day (d6-DM 34 mg/Q 4.9 mg BID). Participants who completed Stage 1 were eligible to participate in Stage 2.
11240293|NCT02477670|FG001|Participant Flow|Stage 1: Placebo|Participants were randomized to receive placebo capsules matched to AVP-786 orally BID. Participants who completed Stage 1 were eligible to participate in Stage 2.
11240294|NCT02477670|FG002|Participant Flow|Stage 1 Placebo Non-responders; Stage 2: Placebo|Participants who were randomized to receive placebo in Stage 1 and were classified as non-responders were re-randomized to receive placebo capsules matched to AVP-786 orally BID for the entire duration of Stage 2.
11240295|NCT02477670|FG003|Participant Flow|Stage 1 Placebo Non-responders; Stage 2: AVP-786|Participants who were randomized to receive placebo in Stage 1 and were classified as non-responders were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1: AVP-786 QD on Day 1 for the first 7 days; scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 BID.
11240296|NCT02477670|FG004|Participant Flow|Stage 1 Placebo Responders; Stage 2: Placebo|Participants who were randomized to receive placebo in Stage 1 and were classified as responders were re-randomized to receive placebo capsules matched to AVP-786 orally BID for the entire duration of Stage 2.
11240297|NCT02477670|FG005|Participant Flow|Stage 1 Placebo Responders; Stage 2: AVP-786|Participants who were randomized to receive placebo in Stage 1 and were classified as responders were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1: AVP-786 QD on Day 1 for the first 7 days; scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 BID.
11240298|NCT02477670|FG006|Participant Flow|Stage 1 AVP-786; Stage 2: AVP-786|Participants who received AVP-786 in Stage 1 continued to receive AVP-786 BID in Stage 2 with no further dose escalations.
11240299|NCT02477670|OG000|Outcome|Stage 1: AVP-786|Participants were randomized to receive AVP-786 once daily (QD) on Day 1 for the first 7 days. Scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 milligrams twice a day (d6-DM 34 mg/Q 4.9 mg BID). Participants who completed Stage 1 were eligible to participate in Stage 2.
11240300|NCT02477670|OG001|Outcome|Stage 1: Placebo|Participants were randomized to receive placebo capsules matched to AVP-786 orally BID. Participants who completed Stage 1 were eligible to participate in Stage 2.
11240301|NCT02477670|OG002|Outcome|Stage 1 Placebo Non-responders; Stage 2: Placebo|Participants who were randomized to receive placebo in Stage 1 and were classified as non-responders were re-randomized to receive placebo capsules matched to AVP-786 orally BID for the entire duration of Stage 2.
11240302|NCT02477670|OG003|Outcome|Stage 1 Placebo Non-responders; Stage 2: AVP-786|Participants who were randomized to receive placebo in Stage 1 and were classified as non-responders were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1: AVP-786 QD on Day 1 for the first 7 days; scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 BID.
11370995|NCT00218036|FG003|Participant Flow|Citalopram 40mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
11370996|NCT00218036|FG004|Participant Flow|Placebo/Methadone Maintenance (1.2mg/kg)|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
11240303|NCT02477670|OG004|Outcome|Stage 1 Placebo Responders; Stage 2: Placebo|Participants who were randomized to receive placebo in Stage 1 and were classified as responders were re-randomized to receive placebo capsules matched to AVP-786 orally BID for the entire duration of Stage 2.
11240304|NCT02477670|OG005|Outcome|Stage 1 Placebo Responders; Stage 2: AVP-786|Participants who were randomized to receive placebo in Stage 1 and were classified as responders were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1: AVP-786 QD on Day 1 for the first 7 days; scheduled dose escalations occurred on Day 8 and Day 14 to a target dose of AVP-786-34/4.9 BID.
11240305|NCT02477670|OG006|Outcome|Stage 1 AVP-786; Stage 2: AVP-786|Participants who received AVP-786 in Stage 1 continued to receive AVP-786 BID in Stage 2 with no further dose escalations.
11240306|NCT02477670|EG000|Reported Event|All Placebo|Participants who received placebo in Stage 1 or Stage 2.
11240307|NCT02477670|EG001|Reported Event|All AVP-786|Participants who received AVP-786 in Stage 1 or Stage 2 (up to a target dose of AVP-786-34/4.9 milligrams twice a day [d6-DM 34 mg/Q 4.9 mg BID]).
11240308|NCT02477709|BG000|Baseline|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
11240309|NCT02477709|FG000|Participant Flow|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
11240310|NCT02477709|OG000|Outcome|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
11240311|NCT02477709|EG000|Reported Event|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
11240312|NCT02477800|BG000|Baseline|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11189916|NCT02122341|EG000|Reported Event|Investigational: BackStop|"Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.~BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F)."
11189917|NCT02122341|EG001|Reported Event|No Intervention: Control|Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
11189918|NCT02122380|BG000|Baseline|Sitagliptin Then Placebo|Participants first received sitagliptin 100 mg by mouth daily for 30 days. After an 8 week washout period, they then received Placebo daily for 30 days.
11189919|NCT02122380|BG001|Baseline|Placebo Then Sitagliptin|Participants first received Placebo daily for 30 days. After an 8 week washout period, they then received Sitagliptin 100 mg daily for 30 days.
11189920|NCT02122380|BG002|Baseline|Total|Total of all reporting groups
11189921|NCT02122380|FG000|Participant Flow|Sitagliptin Then Placebo|Participants first received sitagliptin 100 mg by mouth daily for 30 days. After a washout period of 8 weeks, then then received Placebo daily for 30 days
11189922|NCT02122380|FG001|Participant Flow|Placebo Then Sitagliptin|Participants first received Placebo daily for 30 days. After a washout period of 8 weeks, they then received Sitagliptin 100 mg daily for 30 days
11189923|NCT02122380|OG000|Outcome|Placebo|Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
11189924|NCT02122380|OG001|Outcome|Sitagliptin|Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
11189925|NCT02122380|OG001|Outcome|Sitagliptin|Participants who received Sitagliptin 100 mg each morning in either the first 30 days or last 30 days of the study.
11189926|NCT02122380|EG000|Reported Event|Sitagliptin|Participants received Sitagliptin 100 mg by mouth daily for up to 30 days.
11189927|NCT02122380|EG001|Reported Event|Placebo|Participants received Placebo daily for up to 30 days.
11189928|NCT02122406|BG000|Baseline|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
11370997|NCT00218036|OG000|Outcome|Modafinil 200mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11370998|NCT00218036|OG001|Outcome|Modafinil 400mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11189929|NCT02122406|FG000|Participant Flow|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
11189930|NCT02122406|OG000|Outcome|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
11189931|NCT02122406|EG000|Reported Event|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
11189932|NCT02122445|BG000|Baseline|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
11189933|NCT02122445|FG000|Participant Flow|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
11189934|NCT02122445|OG000|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
11189935|NCT02122445|EG000|Reported Event|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
11189936|NCT02122471|BG000|Baseline|Placebo|Matching placebo tablets QD for 12 weeks
11189937|NCT02122471|BG001|Baseline|Plecanatide 3 mg|Plecanatide tablets 3 mg QD for 12 weeks
11189938|NCT02122471|BG002|Baseline|Plecanatide 6 mg|Plecanatide tablets 6 mg QD for 12 weeks
11189939|NCT02122471|BG003|Baseline|Total|Total of all reporting groups
11189940|NCT02122471|FG000|Participant Flow|Placebo|Matching placebo tablets QD for 12 weeks
11189941|NCT02122471|FG001|Participant Flow|Plecanatide 3 mg|Plecanatide tablets 3 mg QD for 12 weeks
11189942|NCT02122471|FG002|Participant Flow|Plecanatide 6 mg|Plecanatide tablets 6 mg QD for 12 weeks
11189943|NCT02122471|OG000|Outcome|Placebo|Matching placebo tablets QD for 12 weeks
11189944|NCT02122471|OG001|Outcome|Plecanatide 3 mg|Plecanatide tablets 3 mg QD for 12 weeks
11189945|NCT02122471|OG002|Outcome|Plecanatide 6 mg|Plecanatide tablets 6 mg QD for 12 weeks
11189946|NCT02122471|OG002|Outcome|Plecanatide 6 mg|Plecanatide tablets 6 mg QD for 12 week
11189947|NCT02122471|EG000|Reported Event|Placebo|Matching placebo tablets QD for 12 weeks
11189948|NCT02122471|EG001|Reported Event|Plecanatide 3 mg|Plecanatide tablets 3 mg QD for 12 weeks
11189949|NCT02122471|EG002|Reported Event|Plecanatide 6 mg|Plecanatide tablets 6 mg QD for 12 weeks
11189950|NCT02122549|BG000|Baseline|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
11189951|NCT02122549|FG000|Participant Flow|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
11189952|NCT02122549|OG000|Outcome|HWD1000|Subjects wearing the HWD 1000.
11189953|NCT02122549|EG000|Reported Event|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
11189954|NCT02122770|BG000|Baseline|Part A: MLN4924 8 mg/m^2 + Fluconazole 400 mg|MLN4924 8 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 8 along with fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10.
11370999|NCT00218036|OG002|Outcome|Citalopram 20mg/Methadone Maintenance (1.2mg/kg)|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11371000|NCT00218036|OG003|Outcome|Citalopram 40mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
11371001|NCT00218036|OG004|Outcome|Placebo/Methadone Maintenance (1.2mg/kg)|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
11371002|NCT00218036|EG000|Reported Event|Modafinil 200mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11371003|NCT00218036|EG001|Reported Event|Modafinil 400mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11371004|NCT00218036|EG002|Reported Event|Citalopram 20mg/Methadone Maintenance (1.2mg/kg)|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
11371005|NCT00218036|EG003|Reported Event|Citalopram 40mg/Methadone Maintenance (1.2mg/kg)|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
11371006|NCT00218036|EG004|Reported Event|Placebo/Methadone Maintenance (1.2mg/kg)|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
11371007|NCT00240227|BG000|Baseline|All Study Paricipants|"No active medication~Prazosin~FDA approved medication for hypertension"
11371008|NCT00240227|FG000|Participant Flow|All Study Participants|"No active medication~Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
11371009|NCT00240227|OG000|Outcome|Placebo|No active medication
11371010|NCT00240227|OG001|Outcome|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
11371011|NCT00240227|OG001|Outcome|Prazosin|
11371012|NCT00240227|EG000|Reported Event|Placebo|"Placebo no active medication~placebo"
11371013|NCT00240227|EG001|Reported Event|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
11371014|NCT00205868|BG000|Baseline|Spinal Cord Stimulation|Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
11371015|NCT00205868|FG000|Participant Flow|Spinal Cord Stimulation|Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
11371016|NCT00205868|OG000|Outcome|Spinal Cord Stimulation|Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
11371017|NCT00205868|EG000|Reported Event|Spinal Cord Stimulation|Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
11371018|NCT00206375|BG000|Baseline|Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro|Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
11371019|NCT00206375|BG001|Baseline|Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa|"Group 2 will be treated with Growth hormone, synthroid, and lupron.~Growth hormone: Growth hormone + Synthroid + Lupron~Growth hormone treatment and puberty: Lupron once a month and growth hormone daily.~Long term hypothyroidism, treated with thyroxine, GH and GnRHa"
11371020|NCT00206375|BG002|Baseline|Short Term Hypothyroidism, Treated With Thyroxine (Control 2)|Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
11371021|NCT00206375|BG003|Baseline|Total|Total of all reporting groups
11371022|NCT00206375|FG000|Participant Flow|Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro|Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
11371023|NCT00206375|FG001|Participant Flow|Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa|"Group 2 will be treated with Growth hormone, synthroid, and lupron.~Growth hormone: Growth hormone + Synthroid + Lupron~Growth hormone treatment and puberty: Lupron once a month and growth hormone daily.~Long term hypothyroidism, treated with thyroxine, GH and GnRHa"
11371024|NCT00206375|FG002|Participant Flow|Short Term Hypothyroidism, Treated With Thyroxine (Control 2)|Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
11371025|NCT00206375|OG000|Outcome|Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro|Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
11371026|NCT00206375|OG001|Outcome|Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa|"Group 2 will be treated with Growth hormone, synthroid, and lupron.~Growth hormone: Growth hormone + Synthroid + Lupron~Growth hormone treatment and puberty: Lupron once a month and growth hormone daily.~Long term hypothyroidism, treated with thyroxine, GH and GnRHa"
11371027|NCT00206375|OG002|Outcome|Short Term Hypothyroidism, Treated With Thyroxine (Control 2)|Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
11371028|NCT00206375|EG000|Reported Event|Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro|Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
11371029|NCT00206375|EG001|Reported Event|Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa|"Group 2 will be treated with Growth hormone, synthroid, and lupron.~Growth hormone: Growth hormone + Synthroid + Lupron~Growth hormone treatment and puberty: Lupron once a month and growth hormone daily.~Long term hypothyroidism, treated with thyroxine, GH and GnRHa"
11371030|NCT00206375|EG002|Reported Event|Short Term Hypothyroidism, Treated With Thyroxine (Control 2)|Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
11371031|NCT00229931|BG000|Baseline|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
11371032|NCT00229931|BG001|Baseline|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
11371033|NCT00229931|BG002|Baseline|Total|Total of all reporting groups
11371034|NCT00229931|FG000|Participant Flow|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
11371035|NCT00229931|FG001|Participant Flow|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
11371036|NCT00229931|OG000|Outcome|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
11371037|NCT00229931|OG001|Outcome|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
11371038|NCT00229931|EG000|Reported Event|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
11371039|NCT00229931|EG001|Reported Event|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
11371040|NCT00209131|BG000|Baseline|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
11371041|NCT00209131|BG001|Baseline|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
11371042|NCT00209131|BG002|Baseline|Total|Total of all reporting groups
11371043|NCT00209131|FG000|Participant Flow|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
11371044|NCT00209131|FG001|Participant Flow|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
11371045|NCT00209131|OG000|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
11371046|NCT00209131|OG001|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
11371047|NCT00209131|EG000|Reported Event|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
11371048|NCT00209131|EG001|Reported Event|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
11371049|NCT00233090|BG000|Baseline|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
11371050|NCT00233090|BG001|Baseline|Placebo|daily dose of placebo for four weeks
11189955|NCT02122770|BG001|Baseline|Part A: MLN4924 8 mg/m^2 + Itraconazole 200 mg|MLN4924 8 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11371051|NCT00233090|BG002|Baseline|Total|Total of all reporting groups
11371052|NCT00233090|FG000|Participant Flow|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
11371053|NCT00233090|FG001|Participant Flow|Placebo|daily dose of placebo for four weeks
11371054|NCT00233090|OG000|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
11371055|NCT00233090|OG001|Outcome|Placebo|daily dose of placebo for four weeks
11371056|NCT00233090|EG000|Reported Event|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
11371057|NCT00233090|EG001|Reported Event|Placebo|daily dose of placebo for four weeks
11371058|NCT00214149|BG000|Baseline|Breast Brachytherapy to 34 Gy|"breast brachytherapy to a dose of 34 Gy~brachytherapy: breast brachytherapy to 34 Gy"
11371059|NCT00214149|FG000|Participant Flow|Breast Brachytherapy to 34 Gy|"breast brachytherapy to a dose of 34 Gy~brachytherapy: breast brachytherapy to 34 Gy"
11371060|NCT00214149|OG000|Outcome|Breast Brachytherapy to 34 Gy|"breast brachytherapy to a dose of 34 Gy~brachytherapy: breast brachytherapy to 34 Gy"
11371061|NCT00214149|EG000|Reported Event|Breast Brachytherapy to 34 Gy|"breast brachytherapy to a dose of 34 Gy~brachytherapy: breast brachytherapy to 34 Gy"
11371062|NCT00205049|BG000|Baseline|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
11371063|NCT00205049|BG001|Baseline|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
11371064|NCT00205049|BG002|Baseline|Total|Total of all reporting groups
11371065|NCT00205049|FG000|Participant Flow|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
11371066|NCT00205049|FG001|Participant Flow|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
11371067|NCT00205049|OG000|Outcome|Pentoxifylline|
11371068|NCT00205049|OG001|Outcome|Placebo|
11371069|NCT00205049|EG000|Reported Event|Pentoxifylline|
11371070|NCT00205049|EG001|Reported Event|Placebo|
11371071|NCT00209027|BG000|Baseline|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
11371072|NCT00209027|BG001|Baseline|Controls|Baseline fMRI scan
11371073|NCT00209027|BG002|Baseline|Total|Total of all reporting groups
11371074|NCT00209027|FG000|Participant Flow|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
11371075|NCT00209027|FG001|Participant Flow|Controls|Baseline fMRI scan
11371076|NCT00209027|OG000|Outcome|Schizophrenia Subjects|Males patients with schizophrenia
11371077|NCT00209027|OG001|Outcome|Controls|Healthy males without a psychiatric diagnosis
11371078|NCT00209027|EG000|Reported Event|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
11371079|NCT00209027|EG001|Reported Event|Controls|Baseline fMRI scan
11371080|NCT00182637|BG000|Baseline|Bortezomib|administration of bortezomib
11371081|NCT00182637|FG000|Participant Flow|Bortezomib|administration of bortezomib
11371082|NCT00182637|OG000|Outcome|Bortezomib|bortezomib
11371083|NCT00182637|OG000|Outcome|Bortezomib|administration of bortezomib
11371084|NCT00182637|EG000|Reported Event|Bortezomib|administration of bortezomib
11371085|NCT00176488|BG000|Baseline|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
11371086|NCT00176488|FG000|Participant Flow|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.~Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment."
11371087|NCT00176488|OG000|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
11371088|NCT00176488|EG000|Reported Event|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
11371089|NCT00179127|BG000|Baseline|Glargine|"0.3u/kg of glargine, subcutaneously, once~glargine: 0.3u/kg of glargine, subcutaneously, once"
11371090|NCT00179127|BG001|Baseline|Placebo|"0.3u/kg of saline, subcutaneously, once~saline: 0.3u/kg of saline, subcutaneously, once"
11371091|NCT00179127|BG002|Baseline|Total|Total of all reporting groups
11371092|NCT00179127|FG000|Participant Flow|Glarine|glargine: 0.3u/kg of glargine, subq, once
11371093|NCT00179127|FG001|Participant Flow|Placebo|saline: 0.3cc/kg of saline, subq, once
11371094|NCT00179127|OG000|Outcome|Glarine|glargine: 0.3u/kg of glargine, subq, once
11371095|NCT00179127|OG001|Outcome|Placebo|saline: 0.3cc/kg of saline, subq, once
11371096|NCT00179127|EG000|Reported Event|Glarine|glargine: 0.3u/kg of glargine, subq, once
11371097|NCT00179127|EG001|Reported Event|Placebo|saline: 0.3cc/kg of saline, subq, once
11371098|NCT00183963|BG000|Baseline|Arm 1: Control Group|
11371099|NCT00183963|BG001|Baseline|Arm 2: Tamoxifen Group|
11371100|NCT00183963|BG002|Baseline|Arm 3: Low Dose Fulvestrant|
11371101|NCT00183963|BG003|Baseline|Arm 4: High Dose Fulvestrant|
11371102|NCT00183963|BG004|Baseline|Total|Total of all reporting groups
11371103|NCT00183963|FG000|Participant Flow|Arm 1: Control Group|Placebo
11371104|NCT00183963|FG001|Participant Flow|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
11371105|NCT00183963|FG002|Participant Flow|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
11371106|NCT00183963|FG003|Participant Flow|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
11371107|NCT00183963|OG000|Outcome|Arm 1: Control Group|Placebo
11371108|NCT00183963|OG001|Outcome|Arm 2: Tamoxifen Group|20 mg given by mouth daily for 21 days
11371109|NCT00183963|OG002|Outcome|Arm 3: Low Dose Fulvestrant|250 mg given on day 1, administered by IM Injection
11371110|NCT00183963|OG003|Outcome|Arm 4: High Dose Fulvestrant|500 mg given on day 1, administered by IM Injection
11371111|NCT00183963|OG001|Outcome|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
11371112|NCT00183963|OG002|Outcome|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
11371113|NCT00183963|OG003|Outcome|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
11371114|NCT00183963|EG000|Reported Event|Arm 1: Control Group|Placebo
11371115|NCT00183963|EG001|Reported Event|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
11371116|NCT00183963|EG002|Reported Event|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
11371117|NCT00183963|EG003|Reported Event|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
11371118|NCT00178477|BG000|Baseline|Group 1|MRI with Breath Hold
11371119|NCT00178477|FG000|Participant Flow|Breath Hold|MRI with Breath Hold
11371120|NCT00178477|OG000|Outcome|Group 1|MRI with Breath Hold
11371121|NCT00178477|EG000|Reported Event|Group 1|MRI with Breath Hold
11371122|NCT00162773|BG000|Baseline|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
11371123|NCT00162773|FG000|Participant Flow|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks"
11371124|NCT00162773|OG000|Outcome|All Participants|"water injection~Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.~omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
11371125|NCT00162773|EG000|Reported Event|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
11371126|NCT00176631|BG000|Baseline|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
11371127|NCT00176631|FG000|Participant Flow|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
11189956|NCT02122770|BG002|Baseline|Part A: MLN4924 15 mg/m^2 + Itraconazole 200 mg|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11371128|NCT00176631|OG000|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
11371129|NCT00176631|EG000|Reported Event|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
11371130|NCT00176501|BG000|Baseline|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
11371131|NCT00176501|FG000|Participant Flow|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
11371132|NCT00176501|OG000|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
11371133|NCT00176501|EG000|Reported Event|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
11371134|NCT00177970|BG000|Baseline|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
11371135|NCT00177970|BG001|Baseline|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
11371136|NCT00177970|BG002|Baseline|Total|Total of all reporting groups
11371137|NCT00177970|FG000|Participant Flow|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
11371138|NCT00177970|FG001|Participant Flow|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
11371139|NCT00177970|OG000|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
11371140|NCT00177970|OG001|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
11371141|NCT00177970|EG000|Reported Event|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
11371142|NCT00177970|EG001|Reported Event|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
11371143|NCT00177866|BG000|Baseline|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
11371144|NCT00177866|BG001|Baseline|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
11371145|NCT00177866|BG002|Baseline|Total|Total of all reporting groups
11371146|NCT00177866|FG000|Participant Flow|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
11371147|NCT00177866|FG001|Participant Flow|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
11371148|NCT00177866|OG000|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
11371149|NCT00177866|OG001|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
11371150|NCT00177866|EG000|Reported Event|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
11371151|NCT00177866|EG001|Reported Event|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
11371152|NCT00147238|BG000|Baseline|Ferumoxtran-10 MRI Contrast Agent|
11371153|NCT00147238|FG000|Participant Flow|Ferumoxtran-10 MRI Contrast Agent|
11371154|NCT00147238|OG000|Outcome|Ferumoxtran-10 MRI Contrast Agent|
11371155|NCT00147238|EG000|Reported Event|Ferumoxtran-10 MRI Contrast Agent|
11371156|NCT00165503|BG000|Baseline|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
11371157|NCT00165503|FG000|Participant Flow|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
11371158|NCT00165503|OG000|Outcome|Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
11371159|NCT00165503|EG000|Reported Event|Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
11371160|NCT00160563|BG000|Baseline|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
11371161|NCT00160563|BG001|Baseline|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
11189957|NCT02122770|BG003|Baseline|Part A: MLN4924 20 mg/m^2 + Itraconazole 200 mg|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11371162|NCT00160563|BG002|Baseline|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
11371163|NCT00160563|BG003|Baseline|Total|Total of all reporting groups
11371164|NCT00160563|FG000|Participant Flow|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
11371165|NCT00160563|FG001|Participant Flow|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
11371166|NCT00160563|FG002|Participant Flow|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
11189958|NCT02122770|BG004|Baseline|Total|Total of all reporting groups
11371167|NCT00160563|OG000|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
11371168|NCT00160563|OG001|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
11371169|NCT00160563|OG002|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
11371170|NCT00160563|EG000|Reported Event|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
11371171|NCT00160563|EG001|Reported Event|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
11371172|NCT00160563|EG002|Reported Event|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
11371173|NCT00160563|EG003|Reported Event|PLC-LCTZ|Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
11371174|NCT00142519|BG000|Baseline|Methadone|"methadone~Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg"
11371175|NCT00142519|BG001|Baseline|Methadone and Morphine|"methadone and morphine~methadone and morphine: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg"
11371176|NCT00142519|BG002|Baseline|Total|Total of all reporting groups
11371177|NCT00142519|FG000|Participant Flow|Methadone|"methadone~Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg"
11371178|NCT00142519|FG001|Participant Flow|Methadone and Morphine|"methadone and morphine~methadone and morphine: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg"
11240313|NCT02477800|BG001|Baseline|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240314|NCT02477800|BG002|Baseline|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240315|NCT02477800|BG003|Baseline|Total|Total of all reporting groups
11240316|NCT02477800|FG000|Participant Flow|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240317|NCT02477800|FG001|Participant Flow|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240318|NCT02477800|FG002|Participant Flow|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240319|NCT02477800|FG003|Participant Flow|BIIB037 Late Start: Low Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240320|NCT02477800|FG004|Participant Flow|BIIB037 Late Start: High Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240321|NCT02477800|FG005|Participant Flow|BIIB037 Early Start: Low Dose (LTE Period)|Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240322|NCT02477800|FG006|Participant Flow|BIIB037 Early Start: High Dose (LTE Period)|Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11371179|NCT00142519|OG000|Outcome|Methadone|"methadone~Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg"
11371180|NCT00142519|OG001|Outcome|Methadone and Morphine|"methadone and morphine~methadone and morphine: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg"
11371181|NCT00142519|EG000|Reported Event|Methadone|"methadone~Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg"
11240323|NCT02477800|OG000|Outcome|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240324|NCT02477800|OG001|Outcome|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240325|NCT02477800|OG002|Outcome|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240326|NCT02477800|EG000|Reported Event|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240327|NCT02477800|EG001|Reported Event|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240328|NCT02477800|EG002|Reported Event|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11240329|NCT02477800|EG003|Reported Event|BIIB037 Late Start: Low Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240330|NCT02477800|EG004|Reported Event|BIIB037 Late Start: High Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240331|NCT02477800|EG005|Reported Event|BIIB037 Early Start: Low Dose (LTE Period)|Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240332|NCT02477800|EG006|Reported Event|BIIB037 Early Start: High Dose (LTE Period)|Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11240333|NCT02477839|BG000|Baseline|Placebo|Participants received matching placebo syrup.
11240334|NCT02477839|BG001|Baseline|Lacosamide|Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
11240335|NCT02477839|BG002|Baseline|Total Title|
11240336|NCT02477839|FG000|Participant Flow|Placebo|Participants received matching placebo syrup.
11240337|NCT02477839|FG001|Participant Flow|Lacosamide|Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
11240338|NCT02477839|OG000|Outcome|Placebo (FAS)|Participants received matching placebo syrup, forming the Full Analysis Set (FAS).
11240339|NCT02477839|OG001|Outcome|Lacosamide (FAS)|Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.
11240340|NCT02477839|OG000|Outcome|Placebo (SS)|Participants received matching placebo syrup, forming the Safety Set (SS).
11240341|NCT02477839|OG001|Outcome|Lacosamide (SS)|Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.
11240342|NCT02477839|EG000|Reported Event|Placebo (SS)|Participants received matching placebo syrup, forming the Safety Set (SS).
11240343|NCT02477839|EG001|Reported Event|Lacosamide (SS)|Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.
11240344|NCT02478164|BG000|Baseline|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
11240345|NCT02478164|FG000|Participant Flow|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
11240346|NCT02478164|OG000|Outcome|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
11189959|NCT02122770|FG000|Participant Flow|Part A: MLN4924 8 mg/m^2 + Fluconazole 400 mg|MLN4924 8 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 8 along with fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10.
11189960|NCT02122770|FG001|Participant Flow|Part A: MLN4924 8 mg/m^2 + Itraconazole 200 mg|MLN4924 8 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189961|NCT02122770|FG002|Participant Flow|Part A: MLN4924 15 mg/m^2 + Itraconazole 200 mg|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189962|NCT02122770|FG003|Participant Flow|Part A: MLN4924 20 mg/m^2 + Itraconazole 200 mg|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189963|NCT02122770|FG004|Participant Flow|Part B: MLN4924 + Docetaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with docetaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189964|NCT02122770|FG005|Participant Flow|Part B: MLN4924 + Carboplatin or Paclitaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with carboplatin or paclitaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189965|NCT02122770|OG000|Outcome|Part A: MLN4924 8 mg/m^2|MLN4924 8 mg/m^2, infusion, intravenously, once on Day 1.
11189966|NCT02122770|OG001|Outcome|Part A: MLN4924 8 mg/m^2 + Fluconazole 400 mg|MLN4924 8 mg/m^), infusion, intravenously, once on Day 8 along with fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10.
11189967|NCT02122770|OG001|Outcome|Part A: MLN4924 8 mg/m^2 + Itraconazole 200 mg|MLN4924 8 mg/m^2, infusion, intravenously, once on Day 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189968|NCT02122770|OG002|Outcome|Part A: MLN4924 15 mg/m^2|MLN4924 15 mg/m^2, infusion, intravenously, once on Day 1.
11189969|NCT02122770|OG003|Outcome|Part A: MLN4924 15 mg/m^2 + Itraconazole 200 mg|MLN4924 15 mg/m^2, infusion, intravenously, once on Day 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189970|NCT02122770|OG004|Outcome|Part A: MLN4924 20 mg/m^2|MLN4924 20 mg/m^2, infusion, intravenously, once on Day 1.
11189971|NCT02122770|OG005|Outcome|Part A: MLN4924 20 mg/m^2 + Itraconazole 200 mg|MLN4924 20 mg/m^2, infusion, intravenously, once on Day 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189972|NCT02122770|OG000|Outcome|Part A: MLN4924 8 mg/m^2 + Fluconazole 400 mg|MLN4924 8 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 8 along with fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10.
11189973|NCT02122770|OG001|Outcome|Part A: MLN4924 8 mg/m^2 + Itraconazole 200 mg|MLN4924 8 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189974|NCT02122770|OG002|Outcome|Part A: MLN4924 15 mg/m^2 + Itraconazole 200 mg|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189975|NCT02122770|OG003|Outcome|Part A: MLN4924 20 mg/m^2 + Itraconazole 200 mg|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189976|NCT02122770|OG004|Outcome|Part B: MLN4924 + Docetaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with docetaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189977|NCT02122770|OG005|Outcome|Part B: MLN4924 + Carboplatin or Paclitaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with carboplatin or paclitaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189978|NCT02122770|OG000|Outcome|Part B: MLN4924 + Docetaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with docetaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189979|NCT02122770|OG001|Outcome|Part B: MLN4924 + Carboplatin or Paclitaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with carboplatin or paclitaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189980|NCT02122770|EG000|Reported Event|Part A: MLN4924 8 mg/m^2 + Fluconazole 400 mg|MLN4924 8 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 8 along with fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10.
11189981|NCT02122770|EG001|Reported Event|Part A: MLN4924 8 mg/m^2 + Itraconazole 200 mg|MLN4924 8 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189982|NCT02122770|EG002|Reported Event|Part A: MLN4924 15 mg/m^2 + Itraconazole 200 mg|MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189983|NCT02122770|EG003|Reported Event|Part A: MLN4924 20 mg/m^2 + Itraconazole 200 mg|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1 and 8 along with itraconazole, 200 mg, solution, orally, once daily on Days 4-10.
11189984|NCT02122770|EG004|Reported Event|Part B: MLN4924 + Docetaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with docetaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11189985|NCT02122770|EG005|Reported Event|Part B: MLN4924 + Carboplatin or Paclitaxel|MLN4924, 8-20 mg/m^2, on Days 1, 3, and 5 along with carboplatin or paclitaxel at standard dose regimen on Day 1 of a 21-day treatment Cycle until symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped.
11191744|NCT02133235|OG000|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
11371182|NCT00142519|EG001|Reported Event|Methadone and Morphine|"methadone and morphine~methadone and morphine: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg"
11371183|NCT00145704|BG000|Baseline|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
11371184|NCT00145704|BG001|Baseline|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
11371185|NCT00145704|BG002|Baseline|Total|Total of all reporting groups
11371186|NCT00145704|FG000|Participant Flow|Bisphosphonate and Growth Hormone|bisphosphonate use and growth hormone use
11371187|NCT00145704|FG001|Participant Flow|Growth Hormone Only|Growth hormone only, no bisphosphonate will be used
11371188|NCT00145704|OG000|Outcome|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
11371189|NCT00145704|OG001|Outcome|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
11371190|NCT00145704|EG000|Reported Event|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
11371191|NCT00145704|EG001|Reported Event|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
11371192|NCT00138073|BG000|Baseline|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
11371193|NCT00138073|FG000|Participant Flow|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
11371194|NCT00138073|OG000|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
11371195|NCT00138073|EG000|Reported Event|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
11376319|NCT00662792|OG001|Outcome|18µg Tiotropium (Tio18GEL)|18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376320|NCT00662792|EG000|Reported Event|7.5 µg /25 µg Tio /Salmeterol (T+S_PE)|Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376321|NCT00662792|EG001|Reported Event|18 µg Tiotropium (Tio18GEL)|18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376322|NCT00662792|EG002|Reported Event|50 µg Salmeterol MDPI (Salm50DPI)|One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11191745|NCT02133235|OG001|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
11376323|NCT00662792|EG003|Reported Event|18 µg Tiotropium Free Combination (T18GEL+S_DPI)|18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods.
11376324|NCT00662792|EG004|Reported Event|Total Treated|All patients who received at least one dose of study medication.
11376325|NCT00602459|BG000|Baseline|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
11376326|NCT00602459|BG001|Baseline|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
11376327|NCT00602459|BG002|Baseline|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
10850009|NCT00299546|OG001|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
11240347|NCT02478164|EG000|Reported Event|Ponatinib|Drug will be administered once daily per cycle through oral ingestion.
11240348|NCT02478359|BG000|Baseline|Standard Care|Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
11240349|NCT02478359|BG001|Baseline|Physical Activity Coaching (Walk On!)|The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
11240350|NCT02478359|BG002|Baseline|Total|Total of all reporting groups
11240351|NCT02478359|FG000|Participant Flow|Standard Care|Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
11240352|NCT02478359|FG001|Participant Flow|Physical Activity Coaching (Walk On!)|The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
11240353|NCT02478359|OG000|Outcome|Standard Care|Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
11240354|NCT02478359|OG001|Outcome|Physical Activity Coaching (Walk On!)|The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
11240355|NCT02478359|OG000|Outcome|Standard Care|Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
11240356|NCT02478359|OG001|Outcome|Physical Activity Coaching (Walk On!)|"The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.~Physical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support."
11240357|NCT02478359|EG000|Reported Event|Standard Care|Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
11240358|NCT02478359|EG001|Reported Event|Physical Activity Coaching (Walk On!)|The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
11240359|NCT02478372|BG000|Baseline|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
11240360|NCT02478372|BG001|Baseline|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
11240361|NCT02478372|BG002|Baseline|Total|Total of all reporting groups
11240362|NCT02478372|FG000|Participant Flow|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
11337270|NCT03582215|FG005|Participant Flow|Part 2: Aerosol Spray|"Part 2: Aerosol Spray:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337271|NCT03582215|FG006|Participant Flow|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray:~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11189986|NCT02122783|BG000|Baseline|Conventional Then Experimental Brace Resistance|"Conventional intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs~Experimental intervention Same MAFO as above but now using ADR™ soft polymer as brace resistance"
11371196|NCT00113386|BG000|Baseline|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery [Data is reported for eligible patients with on-study information, which is 8 patients.]
11371197|NCT00113386|BG001|Baseline|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with on-study information, which is 7 patients.]
11189987|NCT02122783|BG001|Baseline|Experimental Then Conventional Brace Resistance|"Experimental intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing ADR™ soft polymer as brace resistance~Conventional intervention Same MAFO as above but now using springs/pins as brace resistance"
11189988|NCT02122783|BG002|Baseline|Total|Total of all reporting groups
11189989|NCT02122783|FG000|Participant Flow|Conventional Then Experimental Brace Resistance|"Default intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs~Experimental intervention Same MAFO but with ADR (soft polymer) providing brace resistance"
11189990|NCT02122783|FG001|Participant Flow|Experimental Then Conventional Brace Resistance|"Experimental Condition Using the novel elastomer (ADR™ ) to provide brace resistance~Conventional Condition Same MAFO as above but using pins/springs to provide brace resistance"
11189991|NCT02122783|OG000|Outcome|Conventional Brace Resistance (Hardstop)|"Default intervention~Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs"
11189992|NCT02122783|OG001|Outcome|ADR™ Brace Resistance|"Condition using the novel elastomer to provide brace support~ADR™ brace resistance"
11189993|NCT02122783|OG000|Outcome|Conventional Then Experimental Brace Resistance|"Conventional intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs~Experimental is same MAFO but just using soft polymer inserts to provide the brace resistance"
11189994|NCT02122783|OG001|Outcome|Experimental Then Conventional Brace Resistance|"Condition using the novel elastomer to provide brace support: ADR™ brace resistance~Conventional refers to same brace but using pins/springs to provide brace resistance"
11189995|NCT02122783|OG000|Outcome|Conventional Brace Resistance (Hardstop)|"Conventional intervention:~Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs~Experimental intervention:~Same MAFO as above but with soft polymer insert to provide the brace resistance."
11189996|NCT02122783|EG000|Reported Event|Conventional Brace Resistance (Hardstop)|"Default intervention~Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs"
11189997|NCT02122783|EG001|Reported Event|ADR™ Brace Resistance|"Condition using the novel elastomer to provide brace support~ADR™ brace resistance"
11189998|NCT02122796|BG000|Baseline|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
11189999|NCT02122796|BG001|Baseline|Standard of Care|Standard of care post-mastectomy.
11190000|NCT02122796|BG002|Baseline|Total|Total of all reporting groups
11190001|NCT02122796|FG000|Participant Flow|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
11190002|NCT02122796|FG001|Participant Flow|Standard of Care|Standard of care post-mastectomy.
11190003|NCT02122796|OG000|Outcome|Patients Undergoing Mastectomy Surgery|Number of individuals having mastectomy surgery who were approached for participation in the trial
11190004|NCT02122796|OG000|Outcome|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
11190005|NCT02122796|OG001|Outcome|Standard of Care|Standard of care post-mastectomy.
11190006|NCT02122796|EG000|Reported Event|Acupuncture|"Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.~Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body."
11190007|NCT02122796|EG001|Reported Event|Standard of Care|Standard of care post-mastectomy.
11190008|NCT02122887|BG000|Baseline|Control Group|no intervention for 3 months
11190009|NCT02122887|BG001|Baseline|Experimental Group|"Peace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes.~Peace-Building Intervention Process: The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the Other - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,gift giving, summary of process by group leaders."
11190010|NCT02122887|BG002|Baseline|Total|Total of all reporting groups
11190011|NCT02122887|FG000|Participant Flow|Control Group|no intervention for 3 months
11191746|NCT02133235|OG002|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
11371198|NCT00113386|BG002|Baseline|Total|Total of all reporting groups
11371199|NCT00113386|FG000|Participant Flow|Preoperative Cisplatin/Docetaxel|Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
11371200|NCT00113386|FG001|Participant Flow|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
11371201|NCT00113386|OG000|Outcome|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
11371202|NCT00113386|OG001|Outcome|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
11371203|NCT00113386|EG000|Reported Event|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 9 patients.]
11371204|NCT00113386|EG001|Reported Event|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 7 patients.]
11371205|NCT00138151|BG000|Baseline|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
11371206|NCT00138151|FG000|Participant Flow|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
11371207|NCT00138151|OG000|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
11371208|NCT00138151|EG000|Reported Event|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
11371209|NCT00129974|BG000|Baseline|Arm 1|Pemetrexed and Gemcitabine
11371210|NCT00129974|FG000|Participant Flow|Arm 1|Pemetrexed and Gemcitabine
11371211|NCT00129974|OG000|Outcome|Arm 1|Pemetrexed and Gemcitabine
11371212|NCT00129974|EG000|Reported Event|Arm 1|
11371213|NCT00126659|BG000|Baseline|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
11371214|NCT00126659|BG001|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
11371215|NCT00126659|BG002|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
11371216|NCT00126659|BG003|Baseline|Total|Total of all reporting groups
11371217|NCT00126659|FG000|Participant Flow|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
10850010|NCT00299546|OG002|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
11371218|NCT00126659|FG001|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
11371219|NCT00126659|FG002|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
10850011|NCT00299546|OG003|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
10850012|NCT00299546|EG000|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
10850013|NCT00299546|EG001|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
10850014|NCT00299546|EG002|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
11371220|NCT00126659|OG000|Outcome|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
11371221|NCT00126659|OG001|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
11371222|NCT00126659|OG002|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
11371223|NCT00126659|EG000|Reported Event|Sorafenib + Cytoreductive Nephrectomy|All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
11371224|NCT00133679|BG000|Baseline|Sildenafil|"Sildenafil x 45 days~sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d"
11371225|NCT00133679|BG001|Baseline|Placebo|"Placebo x 45 d~Placebo: Placebo suspension (equal volume to experimental drug) x 45 days"
11371226|NCT00133679|BG002|Baseline|Total|Total of all reporting groups
11371227|NCT00133679|FG000|Participant Flow|Sildenafil|"Sildenafil x 45 days~sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d"
11371228|NCT00133679|FG001|Participant Flow|Placebo|"Placebo x 45 d~Placebo: Placebo suspension (equal volume to experimental drug) x 45 days"
11190012|NCT02122887|FG001|Participant Flow|Experimental Group|"Peace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes.~Peace-Building Intervention Process: The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the Other - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,gift giving, summary of process by group leaders."
11190013|NCT02122887|OG000|Outcome|Control Group|no intervention for 3 months
11371229|NCT00133679|OG000|Outcome|Sildenafil|"Sildenafil x 45 days~sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d"
11371230|NCT00133679|OG001|Outcome|Placebo|"Placebo x 45 d~Placebo: Placebo suspension (equal volume to experimental drug) x 45 days"
11371231|NCT00133679|EG000|Reported Event|Sildenafil|"Sildenafil x 45 days~sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d"
11371232|NCT00133679|EG001|Reported Event|Placebo|"Placebo x 45 d~Placebo: Placebo suspension (equal volume to experimental drug) x 45 days"
11371233|NCT00125268|BG000|Baseline|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
11371234|NCT00125268|BG001|Baseline|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
11371235|NCT00125268|BG002|Baseline|Total|Total of all reporting groups
11371236|NCT00125268|FG000|Participant Flow|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
11371237|NCT00125268|FG001|Participant Flow|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
11371238|NCT00125268|OG000|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
11371239|NCT00125268|OG001|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
11371240|NCT00125268|EG000|Reported Event|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
11371241|NCT00125268|EG001|Reported Event|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
11371242|NCT00113399|BG000|Baseline|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with on-study information, which is 6 patients.]
11371243|NCT00113399|BG001|Baseline|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with on-study information, which is 7 patients.]"
11371244|NCT00113399|BG002|Baseline|Total|Total of all reporting groups
11371245|NCT00113399|FG000|Participant Flow|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
11371246|NCT00113399|FG001|Participant Flow|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
11371247|NCT00113399|OG000|Outcome|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
11371248|NCT00113399|OG001|Outcome|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel"
11371249|NCT00113399|EG000|Reported Event|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
11371250|NCT00113399|EG001|Reported Event|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
11371251|NCT00118053|BG000|Baseline|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
11376328|NCT00602459|BG003|Baseline|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
11376329|NCT00602459|BG004|Baseline|Total|Total of all reporting groups
11371252|NCT00118053|FG000|Participant Flow|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
11371253|NCT00118053|OG000|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
11371254|NCT00118053|EG000|Reported Event|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
11371255|NCT00107614|BG000|Baseline|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
11371256|NCT00107614|FG000|Participant Flow|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
11371257|NCT00107614|OG000|Outcome|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
11371258|NCT00107614|EG000|Reported Event|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
11371259|NCT00107315|BG000|Baseline|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
11371260|NCT00107315|FG000|Participant Flow|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
11371261|NCT00107315|OG000|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
11191747|NCT02133235|OG003|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
11371262|NCT00107315|EG000|Reported Event|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
11371263|NCT00108433|BG000|Baseline|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
11371264|NCT00108433|BG001|Baseline|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
11371265|NCT00108433|BG002|Baseline|Total|Total of all reporting groups
11371266|NCT00108433|FG000|Participant Flow|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
11371267|NCT00108433|FG001|Participant Flow|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
11371268|NCT00108433|OG000|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
11371269|NCT00108433|OG001|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
11371270|NCT00108433|EG000|Reported Event|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
11371271|NCT00108433|EG001|Reported Event|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
11371272|NCT00113919|BG000|Baseline|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
11371273|NCT00113919|FG000|Participant Flow|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
11371274|NCT00113919|OG000|Outcome|Busulfex|
11371275|NCT00113919|EG000|Reported Event|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
11371276|NCT00108342|BG000|Baseline|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
11371277|NCT00108342|BG001|Baseline|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
11371278|NCT00108342|BG002|Baseline|Total|Total of all reporting groups
11371279|NCT00108342|FG000|Participant Flow|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
11371280|NCT00108342|FG001|Participant Flow|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
11371281|NCT00108342|OG000|Outcome|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
11371282|NCT00108342|OG001|Outcome|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
11371283|NCT00108342|EG000|Reported Event|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
11191748|NCT02133235|OG000|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
11371284|NCT00108342|EG001|Reported Event|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
11371285|NCT00100828|BG000|Baseline|Irinotecan|irinotecan hydrochloride
11371286|NCT00100828|FG000|Participant Flow|Irinotecan|irinotecan hydrochloride
11371287|NCT00100828|OG000|Outcome|Irinotecan|irinotecan hydrochloride
11371288|NCT00100828|EG000|Reported Event|Irinotecan|irinotecan hydrochloride
11371289|NCT00104728|BG000|Baseline|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
11371290|NCT00104728|FG000|Participant Flow|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
11371291|NCT00104728|OG000|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
11371292|NCT00104728|EG000|Reported Event|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
11371293|NCT00089414|BG000|Baseline|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
11190014|NCT02122887|OG001|Outcome|Experimental Group|"Peace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes.~Peace-Building Intervention Process: The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the Other - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,gift giving, summary of process by group leaders."
11190015|NCT02122887|EG000|Reported Event|no Intervention for 3 Months|This group did not received any intervention
11190016|NCT02122887|EG001|Reported Event|Experimental Group|"Peace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes.~Peace-Building Intervention Process: The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the Other - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,gift giving, summary of process by group leaders"
11371294|NCT00089414|BG001|Baseline|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
11371295|NCT00089414|BG002|Baseline|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
11371296|NCT00089414|BG003|Baseline|Total|Total of all reporting groups
11371297|NCT00089414|FG000|Participant Flow|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
11371298|NCT00089414|FG001|Participant Flow|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
11371299|NCT00089414|FG002|Participant Flow|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
11371300|NCT00089414|OG000|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
11371301|NCT00089414|OG001|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
11371302|NCT00089414|OG002|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
11371303|NCT00089414|EG000|Reported Event|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
11190017|NCT02122952|BG000|Baseline|Cohort 1|"6.7 X 10^13 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=3)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190018|NCT02122952|BG001|Baseline|Cohort 2|"2.0 X 10^14 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=12)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190019|NCT02122952|BG002|Baseline|Total|Total of all reporting groups
11371304|NCT00089414|EG001|Reported Event|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
11371305|NCT00089414|EG002|Reported Event|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
11371306|NCT00083915|BG000|Baseline|High Dose Melphalan|
11371307|NCT00083915|BG001|Baseline|Mel-DT PACE|
11371308|NCT00083915|BG002|Baseline|Total|Total of all reporting groups
11371309|NCT00083915|FG000|Participant Flow|High Dose Melphalan|
11371310|NCT00083915|FG001|Participant Flow|Mel-DT PACE|
11371311|NCT00083915|OG000|Outcome|High Dose Melphalan|
11371312|NCT00083915|OG001|Outcome|Mel-DT PACE|
11371313|NCT00083915|EG000|Reported Event|High Dose Melphalan|
11371314|NCT00083915|EG001|Reported Event|Mel-DT PACE|
11371315|NCT00090870|BG000|Baseline|PEG-Intron, BM-CSF and Thalidomide|"PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.~GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle~thalidomide: 200mg daily by mouth"
11371316|NCT00090870|FG000|Participant Flow|PEG-Intron, BM-CSF and Thalidomide|"PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.~GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle~thalidomide: 200mg daily by mouth"
11371317|NCT00090870|OG000|Outcome|PEG-Intron, BM-CSF and Thalidomide|"PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.~GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle~thalidomide: 200mg daily by mouth"
11371318|NCT00090870|EG000|Reported Event|PEG-Intron, BM-CSF and Thalidomide|"PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.~GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle~thalidomide: 200mg daily by mouth"
11371319|NCT00088972|BG000|Baseline|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371320|NCT00088972|BG001|Baseline|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371321|NCT00088972|BG002|Baseline|Total|Total of all reporting groups
11371322|NCT00088972|FG000|Participant Flow|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371323|NCT00088972|FG001|Participant Flow|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371324|NCT00088972|OG000|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371325|NCT00088972|OG001|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371326|NCT00088972|EG000|Reported Event|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371327|NCT00088972|EG001|Reported Event|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
11371328|NCT00088829|BG000|Baseline|Paclitaxel|"Paclitaxel given before surgery~paclitaxel: subjects will receive paclitaxel neoadjuvantly~microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis~biopsy: All subjects will have a biopsy to collect tissue~neoadjuvant therapy: paclitaxel is given neoadjuvantly~Paclitaxel: All patients will receive paclitaxel neoadjuvantly"
11371329|NCT00088829|FG000|Participant Flow|Paclitaxel|"Paclitaxel given before surgery~paclitaxel: subjects will receive paclitaxel neoadjuvantly~microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis~biopsy: All subjects will have a biopsy to collect tissue~neoadjuvant therapy: paclitaxel is given neoadjuvantly~Paclitaxel: All patients will receive paclitaxel neoadjuvantly"
11371330|NCT00088829|OG000|Outcome|Paclitaxel|"Paclitaxel given before surgery~paclitaxel: subjects will receive paclitaxel neoadjuvantly~microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis~biopsy: All subjects will have a biopsy to collect tissue~neoadjuvant therapy: paclitaxel is given neoadjuvantly~Paclitaxel: All patients will receive paclitaxel neoadjuvantly"
11371331|NCT00088829|EG000|Reported Event|Paclitaxel|"Paclitaxel given before surgery~paclitaxel: subjects will receive paclitaxel neoadjuvantly~microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis~biopsy: All subjects will have a biopsy to collect tissue~neoadjuvant therapy: paclitaxel is given neoadjuvantly~Paclitaxel: All patients will receive paclitaxel neoadjuvantly"
11371332|NCT00089128|BG000|Baseline|Gemcitabine and Irnotecan|"On day 1 and day 8 of each 21 day cycle:~gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes~irinotecan hydrochloride 100mg/m2 IV over 90 minutes"
11371333|NCT00089128|FG000|Participant Flow|Gemcitabine and Irnotecan|"On day 1 and day 8 of each 21 day cycle:~gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes~irinotecan hydrochloride 100mg/m2 IV over 90 minutes"
11371334|NCT00089128|OG000|Outcome|Gemcitabine and Irnotecan|"On day 1 and day 8 of each 21 day cycle:~gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes~irinotecan hydrochloride 100mg/m2 IV over 90 minutes"
11371335|NCT00089128|EG000|Reported Event|Gemcitabine and Irnotecan|"On day 1 and day 8 of each 21 day cycle:~gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes~irinotecan hydrochloride 100mg/m2 IV over 90 minutes"
11190020|NCT02122952|FG000|Participant Flow|Cohort 1|"6.7 X 10^13 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=3)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190021|NCT02122952|FG001|Participant Flow|Cohort 2|"2.0 X 10^14 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=12)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190022|NCT02122952|OG000|Outcome|Cohort 1|"6.7 X 10^13 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=3)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190023|NCT02122952|OG001|Outcome|Cohort 2|"2.0 X 10^14 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=12)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190024|NCT02122952|EG000|Reported Event|Cohort 1|"6.7 X 10^13 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=3)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190025|NCT02122952|EG001|Reported Event|Cohort 2|"2.0 X 10^14 vg/kg of AVXS-101 delivered one-time through a venous catheter inserted into a peripheral vein (n=12)~AVXS-101: Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter"
11190026|NCT02123017|BG000|Baseline|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
11190027|NCT02123017|BG001|Baseline|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
11190028|NCT02123017|BG002|Baseline|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
11190029|NCT02123017|BG003|Baseline|Total|Total of all reporting groups
11190030|NCT02123017|FG000|Participant Flow|90 Grams Crystalline Lactulose|15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
11190031|NCT02123017|FG001|Participant Flow|135 Grams Crystalline Lactulose|15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
11190032|NCT02123017|FG002|Participant Flow|180 Grams Crystalline Lactulose|15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
11190033|NCT02123017|OG000|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
11190034|NCT02123017|OG001|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
11190035|NCT02123017|OG002|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
11190036|NCT02123017|EG000|Reported Event|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
11190037|NCT02123017|EG001|Reported Event|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
11190038|NCT02123017|EG002|Reported Event|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
11190039|NCT02123134|BG000|Baseline|ATX-101 (Deoxycholic Acid) Injection|Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190040|NCT02123134|BG001|Baseline|Placebo|Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190041|NCT02123134|BG002|Baseline|Total|Total of all reporting groups
11190042|NCT02123134|FG000|Participant Flow|ATX-101 (Deoxycholic Acid) Injection|Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190043|NCT02123134|FG001|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190044|NCT02123134|OG000|Outcome|ATX-101 (Deoxycholic Acid) Injection|Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190045|NCT02123134|OG001|Outcome|Placebo|Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190046|NCT02123134|EG000|Reported Event|ATX-101 (Deoxycholic Acid) Injection|Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190047|NCT02123134|EG001|Reported Event|Placebo|Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11190048|NCT02123251|BG000|Baseline|Financial Incentives|"Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.~Financial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."
11190049|NCT02123251|BG001|Baseline|Control|Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.
11190050|NCT02123251|BG002|Baseline|Total|Total of all reporting groups
11371336|NCT00075608|BG000|Baseline|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
11371337|NCT00075608|FG000|Participant Flow|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
11371338|NCT00075608|OG000|Outcome|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
11191749|NCT02133235|OG001|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
11191750|NCT02133235|OG002|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
11191751|NCT02133235|OG003|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
11191752|NCT02133235|EG000|Reported Event|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
11191753|NCT02133235|EG001|Reported Event|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
11191754|NCT02133352|BG000|Baseline|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
11191755|NCT02133352|FG000|Participant Flow|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
11191756|NCT02133352|OG000|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
11191757|NCT02133352|EG000|Reported Event|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
11191758|NCT02133508|BG000|Baseline|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
11191759|NCT02133508|FG000|Participant Flow|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
11191760|NCT02133508|OG000|Outcome|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
11191761|NCT02133508|EG000|Reported Event|NSCLC Participants|Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
11191762|NCT02133664|BG000|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
11191763|NCT02133664|BG001|Baseline|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
11191764|NCT02133664|BG002|Baseline|Total|Total of all reporting groups
11191765|NCT02133664|FG000|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
11191766|NCT02133664|FG001|Participant Flow|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
11191767|NCT02133664|OG000|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
11191768|NCT02133664|OG001|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
11191769|NCT02133664|EG000|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
11191770|NCT02133664|EG001|Reported Event|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
11191771|NCT02133742|BG000|Baseline|Axitinib 5 mg + Pembrolizumab (MK-3475) 2 mg|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days). Participants received axitinib up to a maximum of 64 cycles and pembrolizumab up to 56 cycles in dose expansion phase (each cycle of 21 days) until documented disease progression or unacceptable toxicity or study discontinuation criteria were met.
11190051|NCT02123251|FG000|Participant Flow|Financial Incentives|"Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended American Diabetes Association (ADA) benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.~Financial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."
11190052|NCT02123251|FG001|Participant Flow|Control|Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.
10850015|NCT00299689|BG000|Baseline|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
11190053|NCT02123251|OG000|Outcome|Financial Incentives|"Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.~Financial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."
11190054|NCT02123251|OG001|Outcome|Control|Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.
11190055|NCT02123251|OG000|Outcome|Financial Incentives|"Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive a maximum of $320 financial incentives annually based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.~Financial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."
11190056|NCT02123251|EG000|Reported Event|Financial Incentives|"Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.~Financial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."
11190057|NCT02123251|EG001|Reported Event|Control|Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.
11190058|NCT02123329|BG000|Baseline|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
11190059|NCT02123329|BG001|Baseline|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
11190060|NCT02123329|BG002|Baseline|Total|Total of all reporting groups
11190061|NCT02123329|FG000|Participant Flow|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
11190062|NCT02123329|FG001|Participant Flow|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
11190063|NCT02123329|OG000|Outcome|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
11190064|NCT02123329|OG001|Outcome|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
10850016|NCT00299689|FG000|Participant Flow|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
10962815|NCT00868608|BG001|Baseline|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
10962816|NCT00868608|BG002|Baseline|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11190065|NCT02123329|EG000|Reported Event|Control Arm|"Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).~Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT)."
10962817|NCT00868608|BG003|Baseline|Total|Total of all reporting groups
11190066|NCT02123329|EG001|Reported Event|Intervention Arm|Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
11371339|NCT00075608|OG000|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
11371340|NCT00075608|OG000|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
11371341|NCT00075608|EG000|Reported Event|Second Transplant|Participants who received a second transplant
11371342|NCT00074724|BG000|Baseline|Medical Therapy|"All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.~Modern medical management: Therapies with evidence-based recommendations.~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.~Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction."
11371343|NCT00074724|BG001|Baseline|CABG|"Surgical revascularization in conjunction with optimal medical therapy.~Coronary Artery Bypass: coronary revascularization using arterial or vein conduits~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium."
11371344|NCT00074724|BG002|Baseline|Total|Total of all reporting groups
11371345|NCT00074724|FG000|Participant Flow|Medical Therapy|"All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.~Modern medical management: Therapies with evidence-based recommendations.~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.~Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction."
11371346|NCT00074724|FG001|Participant Flow|CABG|"Surgical revascularization in conjunction with optimal medical therapy.~Coronary Artery Bypass: coronary revascularization using arterial or vein conduits~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium."
11371347|NCT00074724|OG000|Outcome|Medical Therapy|"All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.~Modern medical management: Therapies with evidence-based recommendations.~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.~Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction."
11371348|NCT00074724|OG001|Outcome|CABG|"Surgical revascularization in conjunction with optimal medical therapy.~Coronary Artery Bypass: coronary revascularization using arterial or vein conduits~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium."
11371349|NCT00074724|EG000|Reported Event|Medical Therapy|"All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.~Modern medical management: Therapies with evidence-based recommendations.~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.~Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction."
11371350|NCT00074724|EG001|Reported Event|CABG|"Surgical revascularization in conjunction with optimal medical therapy.~Coronary Artery Bypass: coronary revascularization using arterial or vein conduits~Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium."
11371351|NCT00085631|BG000|Baseline|Overall Study|Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
11371352|NCT00085631|FG000|Participant Flow|Unavailable|"Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. Completed patients were those who had documented response or follow-up data in the current dataset."
11371353|NCT00085631|FG001|Participant Flow|Chemoradiation|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
11371354|NCT00085631|FG002|Participant Flow|Chemoradiation + Hyperthermia|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
11371355|NCT00085631|OG000|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the primary tumor response rate in this study.
11371356|NCT00085631|OG000|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year failure-free survival rate in this study.
11371357|NCT00085631|OG000|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year local recurrence-free survival rate in this study.
11371358|NCT00085631|OG000|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year overall survival rate in this study.
11371359|NCT00085631|EG000|Reported Event|Overall Study|Patients from both arms were combined in adverse event reporting.
11371360|NCT00062751|BG000|Baseline|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
10850017|NCT00299689|OG000|Outcome|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
10850018|NCT00299689|EG000|Reported Event|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
10850019|NCT00299702|BG000|Baseline|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
10850020|NCT00299702|BG001|Baseline|Abilify|10-30 mg once daily oral for 104 weeks
10850021|NCT00299702|BG002|Baseline|Total|Total of all reporting groups
10850022|NCT00299702|FG000|Participant Flow|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
10850023|NCT00299702|FG001|Participant Flow|Abilify|10-30 mg once daily oral for 104 weeks
10850024|NCT00299702|OG000|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
10850025|NCT00299702|OG001|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
10850026|NCT00299702|EG000|Reported Event|RISPERDAL CONSTA|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
10850027|NCT00299702|EG001|Reported Event|Abilify|10-30 mg once daily oral for 104 weeks
10850028|NCT00299741|BG000|Baseline|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
10850029|NCT00299741|FG000|Participant Flow|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib administered orally at a dosage of 37.5 mg once daily
10850030|NCT00299741|OG000|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
10850031|NCT00299741|EG000|Reported Event|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
10850032|NCT00299975|BG000|Baseline|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850033|NCT00299975|BG001|Baseline|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850034|NCT00299975|BG002|Baseline|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850035|NCT00299975|BG003|Baseline|Total|Total of all reporting groups
10850036|NCT00299975|FG000|Participant Flow|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850037|NCT00299975|FG001|Participant Flow|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850038|NCT00299975|FG002|Participant Flow|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850039|NCT00299975|OG000|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850040|NCT00299975|OG001|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850041|NCT00299975|OG002|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850042|NCT00299975|EG000|Reported Event|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850043|NCT00299975|EG001|Reported Event|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
11371361|NCT00062751|BG001|Baseline|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371362|NCT00062751|BG002|Baseline|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371363|NCT00062751|BG003|Baseline|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
11371364|NCT00062751|BG004|Baseline|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371365|NCT00062751|BG005|Baseline|Total|Total of all reporting groups
11371366|NCT00062751|FG000|Participant Flow|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
11371367|NCT00062751|FG001|Participant Flow|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371368|NCT00062751|FG002|Participant Flow|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371369|NCT00062751|FG003|Participant Flow|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
11371370|NCT00062751|FG004|Participant Flow|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371371|NCT00062751|OG000|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
11371372|NCT00062751|OG001|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371373|NCT00062751|OG002|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371374|NCT00062751|OG003|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
11371375|NCT00062751|OG004|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371376|NCT00062751|EG000|Reported Event|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
10850044|NCT00299975|EG002|Reported Event|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
10850045|NCT00299988|BG000|Baseline|IVIG|Intravenous Immunoglobulin
10850046|NCT00299988|BG001|Baseline|Placebo|placebo
10850047|NCT00299988|BG002|Baseline|Total|Total of all reporting groups
10850048|NCT00299988|FG000|Participant Flow|IVIG|"ivig~Intravenous Immunoglobulin"
10850049|NCT00299988|FG001|Participant Flow|Placebo|
11371377|NCT00062751|EG001|Reported Event|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371378|NCT00062751|EG002|Reported Event|Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants.
11371379|NCT00062751|EG003|Reported Event|After Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants.
11371380|NCT00062751|EG004|Reported Event|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
11371381|NCT00062751|EG005|Reported Event|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
11371382|NCT00066807|BG000|Baseline|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371383|NCT00066807|BG001|Baseline|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371384|NCT00066807|BG002|Baseline|Total|Total of all reporting groups
11371385|NCT00066807|FG000|Participant Flow|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371386|NCT00066807|FG001|Participant Flow|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371387|NCT00066807|OG000|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371388|NCT00066807|OG001|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371389|NCT00066807|EG000|Reported Event|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11190067|NCT02123446|BG000|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
11371390|NCT00066807|EG001|Reported Event|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
11371391|NCT00058188|BG000|Baseline|Treatment With Zoledronate, Calcium and Cholecalciferol|"Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.~cholecalciferol: Given orally~calcium gluconate: Given orally~zoledronic acid: Given IV"
11371392|NCT00058188|BG001|Baseline|Treatment With Calcium and Cholecalciferol|"Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.~cholecalciferol: Given orally~calcium gluconate: Given orally"
11371393|NCT00058188|BG002|Baseline|Total|Total of all reporting groups
11371394|NCT00058188|FG000|Participant Flow|Treatment With Zoledronate, Calcium and Cholecalciferol|"Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.~cholecalciferol: Given orally~calcium gluconate: Given orally~zoledronic acid: Given IV"
11371395|NCT00058188|FG001|Participant Flow|Treatment With Calcium and Cholecalciferol|"Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.~cholecalciferol: Given orally~calcium gluconate: Given orally"
11371396|NCT00058188|OG000|Outcome|Treatment With Zoledronate, Calcium and Cholecalciferol|"Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.~cholecalciferol: Given orally~calcium gluconate: Given orally~zoledronic acid: Given IV"
11371397|NCT00058188|OG001|Outcome|Treatment With Calcium and Cholecalciferol|"Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.~cholecalciferol: Given orally~calcium gluconate: Given orally"
11371398|NCT00058188|EG000|Reported Event|Treatment With Zoledronate, Calcium and Cholecalciferol|"Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.~cholecalciferol: Given orally~calcium gluconate: Given orally~zoledronic acid: Given IV"
11371399|NCT00058188|EG001|Reported Event|Treatment With Calcium and Cholecalciferol|"Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.~cholecalciferol: Given orally~calcium gluconate: Given orally"
11371400|NCT00014560|BG000|Baseline|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
11371401|NCT00014560|FG000|Participant Flow|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
11371402|NCT00014560|OG000|Outcome|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
11371403|NCT00014560|EG000|Reported Event|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
10850050|NCT00299988|OG000|Outcome|IVIG|"ivig~Intravenous Immunoglobulin"
10850051|NCT00299988|OG001|Outcome|Placebo|
10850052|NCT00299988|OG001|Outcome|Placebo|Placebo
10850053|NCT00299988|EG000|Reported Event|IVIG|Intravenous Immunoglobulin
11190068|NCT02123446|FG000|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.
11190069|NCT02123446|FG001|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
11190070|NCT02123446|OG000|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11371404|NCT00038142|BG000|Baseline|Arm A: VACdxr With ImmTher|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week for 50-52 weeks.
11371405|NCT00038142|BG001|Baseline|Arm B: VACdxr|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin).
11371406|NCT00038142|BG002|Baseline|Total|Total of all reporting groups
11371407|NCT00038142|FG000|Participant Flow|Arm A: VACdxr With ImmTher|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week for 50-52 weeks.
11371408|NCT00038142|FG001|Participant Flow|Arm B: VACdxr|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin).
11371409|NCT00038142|OG000|Outcome|Arm A: VACdxr With ImmTher|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week for 50-52 weeks.
11371410|NCT00038142|OG001|Outcome|Arm B: VACdxr|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin).
11371411|NCT00038142|EG000|Reported Event|Arm A: VACdxr With ImmTher|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week for 50-52 weeks.
11371412|NCT00038142|EG001|Reported Event|Arm B: VACdxr|Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin).
11371413|NCT00020722|BG000|Baseline|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
11371414|NCT00020722|FG000|Participant Flow|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
11371415|NCT00020722|OG000|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
11371416|NCT00020722|OG000|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.~Carboplatin at a dose of"
11371417|NCT00020722|EG000|Reported Event|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
11371418|NCT00002975|BG000|Baseline|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
11371419|NCT00002975|FG000|Participant Flow|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
11371420|NCT00002975|OG000|Outcome|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
10850054|NCT00299988|EG001|Reported Event|Placebo|Placebo (no treatment)
11371421|NCT00002975|EG000|Reported Event|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
11371422|NCT00006478|BG000|Baseline|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
11371423|NCT00006478|FG000|Participant Flow|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
11371424|NCT00006478|OG000|Outcome|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
11371425|NCT00006478|EG000|Reported Event|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
11371426|NCT00019747|BG000|Baseline|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
11371427|NCT00019747|BG001|Baseline|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
11371428|NCT00019747|BG002|Baseline|Total|Total of all reporting groups
11371429|NCT00019747|FG000|Participant Flow|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
11371430|NCT00019747|FG001|Participant Flow|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
11371431|NCT00019747|OG000|Outcome|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
11371432|NCT00019747|OG001|Outcome|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
11371433|NCT00019747|EG000|Reported Event|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
11371434|NCT00019747|EG001|Reported Event|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
11371435|NCT00006916|BG000|Baseline|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
11371436|NCT00006916|FG000|Participant Flow|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
11371437|NCT00006916|OG000|Outcome|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
11371438|NCT00006916|EG000|Reported Event|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
11371439|NCT00003726|BG000|Baseline|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
11371440|NCT00003726|FG000|Participant Flow|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
11371441|NCT00003726|OG000|Outcome|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
11371442|NCT00003726|EG000|Reported Event|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
10850055|NCT00300053|BG000|Baseline|CLBS14: Low-Dose Group|Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
11190071|NCT02123446|OG001|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11371443|NCT04051996|BG000|Baseline|DAC5|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371444|NCT04051996|BG001|Baseline|DAC10|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371445|NCT04051996|BG002|Baseline|Total|Total of all reporting groups
11371446|NCT04051996|FG000|Participant Flow|DAC5|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371447|NCT04051996|FG001|Participant Flow|DAC10|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371448|NCT04051996|OG000|Outcome|DAC5|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371449|NCT04051996|OG001|Outcome|DAC10|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371450|NCT04051996|EG000|Reported Event|DAC5|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371451|NCT04051996|EG001|Reported Event|DAC10|"Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.~Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily.~Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days."
11371452|NCT02970799|BG000|Baseline|Intranasal Then Extranasal Application|Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
11371453|NCT02970799|BG001|Baseline|Extranasal Then Intranasal Application|Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
11371454|NCT02970799|BG002|Baseline|Total|Total of all reporting groups
11371455|NCT02970799|FG000|Participant Flow|Intranasal Then Extranasal Application|Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
11371456|NCT02970799|FG001|Participant Flow|Extranasal Then Intranasal Application|Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
11371457|NCT02970799|OG000|Outcome|Intranasal Application|Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.
11371458|NCT02970799|OG001|Outcome|Extranasal Application|Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
11371459|NCT02970799|EG000|Reported Event|Intranasal Application|Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.
11371460|NCT02970799|EG001|Reported Event|Extranasal Application|Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
11190072|NCT02123446|EG000|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11190073|NCT02123446|EG001|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11371461|NCT02385292|BG000|Baseline|Intranasal Then Extranasal Application|Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371462|NCT02385292|BG001|Baseline|Extranasal Then Intranasal Application|Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371463|NCT02385292|BG002|Baseline|Total|Total of all reporting groups
11371464|NCT02385292|FG000|Participant Flow|Intranasal Then Extranasal Application|Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371465|NCT02385292|FG001|Participant Flow|Extranasal Then Intranasal Application|Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371466|NCT02385292|OG000|Outcome|Intranasal Application|Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371467|NCT02385292|OG001|Outcome|Extranasal Application|Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371468|NCT02385292|EG000|Reported Event|Intranasal Application|Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371469|NCT02385292|EG001|Reported Event|Extranasal Application|Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
11371470|NCT02126878|BG000|Baseline|Kenaglog 20mg|"20mg/ 2ml and local anesthetic~Kenalog"
11371471|NCT02126878|BG001|Baseline|Kenalog 40mg|"40mg/ 2ml with local anesthetic~Kenalog"
11371472|NCT02126878|BG002|Baseline|Kenalog 80mg|"80mg/ 2ml and local anesthetic~Kenalog"
11371473|NCT02126878|BG003|Baseline|Total|Total of all reporting groups
11371474|NCT02126878|FG000|Participant Flow|Kenaglog 20mg|"20mg/ 2ml and local anesthetic~Kenalog"
11371475|NCT02126878|FG001|Participant Flow|Kenalog 40mg|"40mg/ 2ml with local anesthetic~Kenalog"
11371476|NCT02126878|FG002|Participant Flow|Kenalog 80mg|"80mg/ 2ml and local anesthetic~Kenalog"
11371477|NCT02126878|OG000|Outcome|Kenaglog 20mg|"20mg/ 2ml and local anesthetic~Kenalog"
11371478|NCT02126878|OG001|Outcome|Kenalog 40mg|"40mg/ 2ml with local anesthetic~Kenalog"
11371479|NCT02126878|OG002|Outcome|Kenalog 80mg|"80mg/ 2ml and local anesthetic~Kenalog"
11371480|NCT02126878|EG000|Reported Event|Kenaglog 20mg|"20mg/ 2ml and local anesthetic~Kenalog"
11371481|NCT02126878|EG001|Reported Event|Kenalog 40mg|"40mg/ 2ml with local anesthetic~Kenalog"
11371482|NCT02126878|EG002|Reported Event|Kenalog 80mg|"80mg/ 2ml and local anesthetic~Kenalog"
11371483|NCT02221817|BG000|Baseline|Blind|"Trochanter injection~Trochanter bursa injections"
11371484|NCT02221817|BG001|Baseline|Ultrasound|"Trochanter injection~Trochanter bursa injections~Ultrasound"
11371485|NCT02221817|BG002|Baseline|Total|Total of all reporting groups
10850056|NCT00300053|BG001|Baseline|CLBS14: High-Dose Group|Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
11371486|NCT02221817|FG000|Participant Flow|Blind|"Trochanter injection~Trochanter bursa injections"
11371487|NCT02221817|FG001|Participant Flow|Ultrasound|"Trochanter injection~Trochanter bursa injections~Ultrasound"
11371488|NCT02221817|OG000|Outcome|Blind|"Trochanter injection~Trochanter bursa injections"
11371489|NCT02221817|OG001|Outcome|Ultrasound|"Trochanter injection~Trochanter bursa injections~Ultrasound"
11371490|NCT02221817|EG000|Reported Event|Blind|"Trochanter injection~Trochanter bursa injections"
11371491|NCT02221817|EG001|Reported Event|Ultrasound|"Trochanter injection~Trochanter bursa injections~Ultrasound"
11371492|NCT02595996|BG000|Baseline|Treatment|"Patients will be given propranolol in escalating doses~Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day"
11371493|NCT02595996|FG000|Participant Flow|Treatment|"Patients will be given propranolol in escalating doses~Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day"
11371494|NCT02595996|OG000|Outcome|Treatment|"Patients will be given propranolol in escalating doses~Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day"
10850057|NCT00300053|BG002|Baseline|Placebo Control|Intramyocardial placebo injections
11371495|NCT02595996|EG000|Reported Event|Treatment|"Patients will be given propranolol in escalating doses~Propranolol: escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day"
11371496|NCT03879044|BG000|Baseline|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371497|NCT03879044|FG000|Participant Flow|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371498|NCT03879044|OG000|Outcome|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371499|NCT03879044|EG000|Reported Event|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371500|NCT03198156|BG000|Baseline|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes daily for 4 sessions~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371501|NCT03198156|BG001|Baseline|Sham Stimulation|"Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.~Sham stimulation: Sham stimulation"
11371502|NCT03198156|BG002|Baseline|Total|Total of all reporting groups
11371503|NCT03198156|FG000|Participant Flow|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes daily for 4 sessions~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371504|NCT03198156|FG001|Participant Flow|Sham Stimulation|"Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.~Sham stimulation: Sham stimulation"
11371505|NCT03198156|OG000|Outcome|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes daily for 4 sessions~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371506|NCT03198156|OG001|Outcome|Sham Stimulation|"Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.~Sham stimulation: Sham stimulation"
11371507|NCT03198156|EG000|Reported Event|Transcranial Direct Current Stimulation|"Active tDCS for 30 minutes daily for 4 sessions~Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region."
11371508|NCT03198156|EG001|Reported Event|Sham Stimulation|"Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.~Sham stimulation: Sham stimulation"
11371509|NCT02009384|BG000|Baseline|Ipilimumab|"IV ipilimumab~Ipilimumab: administration of IV ipilimumab for up to 4 cycles"
11371510|NCT02009384|FG000|Participant Flow|Ipilimumab|"IV ipilimumab~Ipilimumab: administration of IV ipilimumab for up to 4 cycles~Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed"
11371511|NCT02009384|OG000|Outcome|Ipilimumab|"IV ipilimumab~Ipilimumab: administration of IV ipilimumab for up to 4 cycles~Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed"
11371512|NCT02009384|EG000|Reported Event|Ipilimumab|dosage:3 mg/kg of subject weight dosage form: Intravenous administration on Ipilimumab frequency of administration: Ipilimumab: administration of IV ipilimumab every three weeks for up to 4 cycles
11371513|NCT04558125|BG000|Baseline|All Study Participants|"TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).~OR~Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin)."
11371514|NCT04558125|FG000|Participant Flow|All Study Participants|"TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).~OR~Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin)."
11371515|NCT04558125|OG000|Outcome|All Study Participants|"TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).~OR~Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin)."
11371516|NCT04558125|EG000|Reported Event|All Study Participants|"TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).~OR~Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin)."
11371517|NCT02401308|BG000|Baseline|Awake DBS Surgery|"Deep brain stimulation surgery: Parkinson's patients undergoing traditional awake DBS surgery utilizing microelectrode recordings and intra-operative stimulation~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
10850058|NCT00300053|BG003|Baseline|Total|Total of all reporting groups
11371518|NCT02401308|BG001|Baseline|Asleep DBS Surgery|"Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371519|NCT02401308|BG002|Baseline|Total|Total of all reporting groups
11371520|NCT02401308|FG000|Participant Flow|Awake DBS Surgery|"Deep brain stimulation surgery: Parkinson's patients undergoing traditional awake DBS surgery utilizing microelectrode recordings and intra-operative stimulation~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371521|NCT02401308|FG001|Participant Flow|Asleep DBS Surgery|"Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371522|NCT02401308|OG000|Outcome|Awake DBS Surgery|"Deep brain stimulation surgery: Parkinson's patients undergoing traditional awake DBS surgery utilizing microelectrode recordings and intra-operative stimulation~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371523|NCT02401308|OG001|Outcome|Asleep DBS Surgery|"Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371524|NCT02401308|EG000|Reported Event|Awake DBS Surgery|"Deep brain stimulation surgery: Parkinson's patients undergoing traditional awake DBS surgery utilizing microelectrode recordings and intra-operative stimulation~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371525|NCT02401308|EG001|Reported Event|Asleep DBS Surgery|"Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.~Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep"
11371526|NCT04381988|BG000|Baseline|Hydroxychloroquine|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.~Hydroxychloroquine: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371527|NCT04381988|BG001|Baseline|Placebo|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.~Placebo: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371528|NCT04381988|BG002|Baseline|Total|Total of all reporting groups
11371529|NCT04381988|FG000|Participant Flow|Hydroxychloroquine|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.~Hydroxychloroquine: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371530|NCT04381988|FG001|Participant Flow|Placebo|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.~Placebo: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371531|NCT04381988|OG000|Outcome|Hydroxychloroquine|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.~Hydroxychloroquine: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371532|NCT04381988|OG001|Outcome|Placebo|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.~Placebo: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371533|NCT04381988|EG000|Reported Event|Hydroxychloroquine|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.~Hydroxychloroquine: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371534|NCT04381988|EG001|Reported Event|Placebo|"Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily.~Placebo: 400mg daily~Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist."
11371535|NCT00521885|BG000|Baseline|Arixtra (Fondaparinox) 2.5 mg Given SubCutaneously Daily|"Subjects may be randomized to Arixtra (Fondaparinox) 2.5 mg given SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first~Arixtra: Arixtra 2.5mg Sc Daily"
11371536|NCT00521885|BG001|Baseline|Lovenox 40mg SubCutaneously Daily|"Subjects may be randomized to Lovenox 40mg SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first~Lovenox: Lovenox 40mg SC Daily"
11371537|NCT00521885|BG002|Baseline|Total|Total of all reporting groups
11371538|NCT00521885|FG000|Participant Flow|Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC) Daily|"In this arm subjects will be randomized to Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC) once a day starting on day 1 and continuing through day 14 or day of discharge, whichever comes first.~Arixtra: Arixtra 2.5mg Sc Daily"
11371539|NCT00521885|FG001|Participant Flow|Lovenox 40mg Subcutaneously (SC) Daily|"Subjects will be randomized using a random generated listing of numbers with arm assignments associated with each assigned number. Only the study pharmacist will have access to this randomization code. All other study team members will remain blinded to the treatment arm. In this arm subjects will be randomized to Lovenox 40mg Subcutaneously (SC) Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first.~Lovenox: Lovenox 40mg SC Daily"
11371540|NCT00521885|OG000|Outcome|Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC)Once a|"Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day~Arixtra: Arixtra 2.5mg Sc Daily"
11371541|NCT00521885|OG001|Outcome|Lovenox 40mg Subcutaneously (SC) Daily|"Lovenox 40mg Subcutaneously (SC) Daily~Lovenox: Lovenox 40mg SC Daily"
11190074|NCT02123459|BG000|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
11371542|NCT00521885|EG000|Reported Event|Arixtra (Fondaparinox) 2.5 mg Given SC Daily|"Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day~Arixtra: Arixtra 2.5mg Sc Daily"
11371543|NCT00521885|EG001|Reported Event|Lovenox 40mg SC Daily|"Lovenox 40mg Subcutaneously (SC) Daily~Lovenox: Lovenox 40mg SC Daily"
11371544|NCT02376946|BG000|Baseline|Actipatch|"The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.~ActiPatch(TM): Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema."
11371545|NCT02376946|BG001|Baseline|Placebo|"The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.~Placebo: Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema."
11371546|NCT02376946|BG002|Baseline|Total|Total of all reporting groups
11371547|NCT02376946|FG000|Participant Flow|Actipatch|"The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.~ActiPatch(TM): Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema."
11371548|NCT02376946|FG001|Participant Flow|Placebo|"The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.~Placebo: Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema."
11371549|NCT02376946|OG000|Outcome|Actipatch|"The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.~ActiPatch(TM): Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema."
11371550|NCT02376946|OG001|Outcome|Placebo|"The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.~Placebo: Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema."
11371551|NCT02376946|EG000|Reported Event|Actipatch|"The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.~ActiPatch(TM): Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema."
11371552|NCT02376946|EG001|Reported Event|Placebo|"The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.~Placebo: Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema."
11371553|NCT01780636|BG000|Baseline|Botulinum Toxin (Botox) Injection|"All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.~botulinum toxin"
11371554|NCT01780636|FG000|Participant Flow|Botulinum Toxin (Botox) Injection|"All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.~botulinum toxin"
11371555|NCT01780636|OG000|Outcome|Botulinum Toxin (Botox) Injection|"All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.~botulinum toxin"
11371556|NCT01780636|EG000|Reported Event|Botulinum Toxin (Botox) Injection|"All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.~botulinum toxin"
11371557|NCT00479167|BG000|Baseline|Bortezomib in Combination With Tositumomab|
11371558|NCT00479167|FG000|Participant Flow|Bortezomib in Combination With Tositumomab|
10850059|NCT00300053|FG000|Participant Flow|CLBS14: Low-Dose Group|Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
11371559|NCT00479167|OG000|Outcome|Bortezomib Combined With Tositumomab and Iodine I 131 Tositumomab|Bortezomib Combined With Tositumomab and Iodine I 131 Tositumomab
11371560|NCT00479167|OG000|Outcome|Bortezomib and Tositumomab I-131|Bortezomib and Tositumomab I-131
11371561|NCT00479167|EG000|Reported Event|Bortezomib in Combination With Tositumomab|Bortezomib in combination with tositumomab
11371562|NCT03998189|BG000|Baseline|Female Participants|"45 female patients will be screened to participate.~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371563|NCT03998189|BG001|Baseline|Male Participants|"45 male patients will be screened to participate~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371564|NCT03998189|BG002|Baseline|Total|Total of all reporting groups
11190075|NCT02123459|FG000|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.
11190076|NCT02123459|FG001|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
11190077|NCT02123459|OG000|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
11190078|NCT02123459|OG001|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
11190079|NCT02123459|EG000|Reported Event|Cephalexin (Reference)|"Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods~Cephalexin: Administered orally"
11190080|NCT02123459|EG001|Reported Event|Cephalexin (Test)|"Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods~Cephalexin: Administered orally"
11190081|NCT02123472|BG000|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion)
11190082|NCT02123472|FG000|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.
11190083|NCT02123472|FG001|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
11190084|NCT02123472|OG000|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11371565|NCT03998189|FG000|Participant Flow|Female Participants|"45 female patients will be screened to participate.~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371566|NCT03998189|FG001|Participant Flow|Male Participants|"45 male patients will be screened to participate~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371567|NCT03998189|OG000|Outcome|Female Participants|"45 female patients will be screened to participate.~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371568|NCT03998189|OG001|Outcome|Male Participants|"45 male patients will be screened to participate~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371569|NCT03998189|EG000|Reported Event|Female Participants|"45 female patients will be screened to participate.~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371570|NCT03998189|EG001|Reported Event|Male Participants|"45 male patients will be screened to participate~Breath Collection: Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing~Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes~Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube~Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers~Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected~Medical History Data Collection: Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease."
11371571|NCT02212574|BG000|Baseline|Chemotherapy|"Chemo Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.~Chemo Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 and 6 hours. Vincristine given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8. Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine: Chemo Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15.~Cisplatin: Chemo Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.~Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2.~Mesna: Chemo Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 & 6 hours.~Vincristine: Chemo Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8."
11376330|NCT00602459|FG000|Participant Flow|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
11371572|NCT02212574|FG000|Participant Flow|Chemotherapy|"Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.~Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15.~Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.~Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2.~Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours.~Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8."
11371573|NCT02212574|OG000|Outcome|All Patients|"Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.~Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15.~Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.~Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2.~Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours.~Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8."
11371574|NCT02212574|OG000|Outcome|Chemotherapy|"Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.~Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15.~Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.~Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2.~Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours.~Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8."
11371575|NCT02212574|EG000|Reported Event|All Participants|"Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days.~Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15.~Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1.~Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2.~Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours.~Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8."
11371576|NCT04422210|BG000|Baseline|Dose Escalation (Arm A1) (Maintenance Only)|Cohort A1: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were administered continuous maintenance therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371577|NCT04422210|BG001|Baseline|Dose Escalation (Arm A2) (Maintenance Only)|Cohort A2: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371578|NCT04422210|BG002|Baseline|Dose Escalation (Arm A3) (Maintenance Only)|Cohort A3: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. This cohort maybe explored if Dose-Limiting Toxicities (DLTs) are experienced and adverse events are thought to be potentially mitigated with a lower dose of venetoclax.
11371579|NCT04422210|BG003|Baseline|Dose Escalation (Arm B1) (Induction + Maintenance)|Cohort B1: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371580|NCT04422210|BG004|Baseline|Dose Escalation (Arm B2) (Induction + Maintenance)|Cohort B2: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371581|NCT04422210|BG005|Baseline|Dose Escalation (Arm B3) (Induction + Maintenance)|Cohort B3: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371582|NCT04422210|BG006|Baseline|Dose Escalation (Arm B4) (Induction + Maintenance)|Cohort B4: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 14, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371583|NCT04422210|BG007|Baseline|Dose Expansion|If the Recommended Phase II Dose (RP2D) for Venetoclax during induction is established, then the dose-expansion cohort would continue to test venetoclax in both induction and maintenance. Participants would be administered non-continuous induction therapy with Venetoclax (RP2D-I/induction RP2D), Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3 followed by continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. If significant toxicity and DLTs in induction precluded identification of an RP2D for venetoclax in induction treatment, then the safety and efficacy of venetoclax would only be investigated in dose-expansion in the maintenance setting. Participants would be administered continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371584|NCT04422210|BG008|Baseline|Total|Total of all reporting groups
11371585|NCT04422210|FG000|Participant Flow|Dose Escalation (Arm A1) (Maintenance Only)|Cohort A1: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were administered continuous maintenance therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371586|NCT04422210|FG001|Participant Flow|Dose Escalation (Arm A2) (Maintenance Only)|Cohort A2: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11190085|NCT02123472|OG001|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11190086|NCT02123472|EG000|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
11371587|NCT04422210|FG002|Participant Flow|Dose Escalation (Arm A3) (Maintenance Only)|Cohort A3: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. This cohort maybe explored if Dose-Limiting Toxicities (DLTs) are experienced and adverse events are thought to be potentially mitigated with a lower dose of venetoclax.
11371588|NCT04422210|FG003|Participant Flow|Dose Escalation (Arm B1) (Induction + Maintenance)|Cohort B1: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11190087|NCT02123472|EG001|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11190088|NCT02123485|BG000|Baseline|Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)|"Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week~Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT."
11190089|NCT02123485|BG001|Baseline|Sham-rTMS|"Sham right prefrontal rTMS 2 times a week~Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT."
11371589|NCT04422210|FG004|Participant Flow|Dose Escalation (Arm B2) (Induction + Maintenance)|Cohort B2: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371590|NCT04422210|FG005|Participant Flow|Dose Escalation (Arm B3) (Induction + Maintenance)|Cohort B3: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371591|NCT04422210|FG006|Participant Flow|Dose Escalation (Arm B4) (Induction + Maintenance)|Cohort B4: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 14, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371592|NCT04422210|FG007|Participant Flow|Dose Expansion|If the Recommended Phase II Dose (RP2D) for Venetoclax during induction is established, then the dose-expansion cohort would continue to test venetoclax in both induction and maintenance. Participants would be administered non-continuous induction therapy with Venetoclax (RP2D-I/induction RP2D), Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3 followed by continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. If significant toxicity and DLTs in induction precluded identification of an RP2D for venetoclax in induction treatment, then the safety and efficacy of venetoclax would only be investigated in dose-expansion in the maintenance setting. Participants would be administered continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371593|NCT04422210|OG000|Outcome|Dose Escalation (Arm A1) (Maintenance Only)|Cohort A1: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were administered continuous maintenance therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371594|NCT04422210|OG001|Outcome|Dose Escalation (Arm A2) (Maintenance Only)|Cohort A2: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371595|NCT04422210|OG002|Outcome|Dose Escalation (Arm A3) (Maintenance Only)|Cohort A3: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. This cohort maybe explored if Dose-Limiting Toxicities (DLTs) are experienced and adverse events are thought to be potentially mitigated with a lower dose of venetoclax.
11371596|NCT04422210|OG003|Outcome|Dose Escalation (Arm B1) (Induction + Maintenance)|Cohort B1: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371597|NCT04422210|OG004|Outcome|Dose Escalation (Arm B2) (Induction + Maintenance)|Cohort B2: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371598|NCT04422210|OG005|Outcome|Dose Escalation (Arm B3) (Induction + Maintenance)|Cohort B3: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
10850060|NCT00300053|FG001|Participant Flow|CLBS14: High-Dose Group|Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
11371599|NCT04422210|OG006|Outcome|Dose Escalation (Arm B4) (Induction + Maintenance)|Cohort B4: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 14, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371600|NCT04422210|OG007|Outcome|Dose Expansion|If the Recommended Phase II Dose (RP2D) for Venetoclax during induction is established, then the dose-expansion cohort would continue to test venetoclax in both induction and maintenance. Participants would be administered non-continuous induction therapy with Venetoclax (RP2D-I/induction RP2D), Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3 followed by continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. If significant toxicity and DLTs in induction precluded identification of an RP2D for venetoclax in induction treatment, then the safety and efficacy of venetoclax would only be investigated in dose-expansion in the maintenance setting. Participants would be administered continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371601|NCT04422210|OG000|Outcome|Dose Expansion|If the Recommended Phase II Dose (RP2D) for Venetoclax during induction is established, then the dose-expansion cohort would continue to test venetoclax in both induction and maintenance. Participants would be administered non-continuous induction therapy with Venetoclax (RP2D-I/induction RP2D), Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3 followed by continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. If significant toxicity and DLTs in induction precluded identification of an RP2D for venetoclax in induction treatment, then the safety and efficacy of venetoclax would only be investigated in dose-expansion in the maintenance setting. Participants would be administered continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371602|NCT04422210|EG000|Reported Event|Dose Escalation (Arm A1) (Maintenance Only)|Cohort A1: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were administered continuous maintenance therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371603|NCT04422210|EG001|Reported Event|Dose Escalation (Arm A2) (Maintenance Only)|Cohort A2: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371604|NCT04422210|EG002|Reported Event|Dose Escalation (Arm A3) (Maintenance Only)|Cohort A3: Participants with ES-SCLC who completed 4-6 cycles of carboplatin and etoposide first-line induction chemotherapy, with or without atezolizumab, were to be administered continuous maintenance therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 21 and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. This cohort maybe explored if Dose-Limiting Toxicities (DLTs) are experienced and adverse events are thought to be potentially mitigated with a lower dose of venetoclax.
11371605|NCT04422210|EG003|Reported Event|Dose Escalation (Arm B1) (Induction + Maintenance)|Cohort B1: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (200mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371606|NCT04422210|EG004|Reported Event|Dose Escalation (Arm B2) (Induction + Maintenance)|Cohort B2: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (400mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371607|NCT04422210|EG005|Reported Event|Dose Escalation (Arm B3) (Induction + Maintenance)|Cohort B3: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 7, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11371608|NCT04422210|EG006|Reported Event|Dose Escalation (Arm B4) (Induction + Maintenance)|Cohort B4: Participants with ES-SCLC were to be administered non-continuous induction therapy with Venetoclax (800mg) once daily (QD) from Day 1 to 14, Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3. Participants who tolerated study treatment without excessive toxicity, and had not undergone disease progression were to be then proceeded to maintenance treatment with venetoclax plus atezolizumab. The venetoclax dose for the maintenance setting in Arm B will be the dose that has been cleared in the maintenance only arm (Arm A) of the study (maintenance RP2D, RP2D-M).
11190090|NCT02123485|BG002|Baseline|Total|Total of all reporting groups
11190091|NCT02123485|FG000|Participant Flow|Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS)|"Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week~Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT."
11371609|NCT04422210|EG007|Reported Event|Dose Expansion|If the Recommended Phase II Dose (RP2D) for Venetoclax during induction is established, then the dose-expansion cohort would continue to test venetoclax in both induction and maintenance. Participants would be administered non-continuous induction therapy with Venetoclax (RP2D-I/induction RP2D), Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1, Carboplatin (5mg/mL/min) on Day 1 and Etoposide (100mg/m^2) on Days 1-3 followed by continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1. If significant toxicity and DLTs in induction precluded identification of an RP2D for venetoclax in induction treatment, then the safety and efficacy of venetoclax would only be investigated in dose-expansion in the maintenance setting. Participants would be administered continuous maintenance therapy with Venetoclax (RP2D-M) and Atezolizumab (1200mg) every 3 weeks (Q3W) on Day 1.
11371610|NCT04298918|BG000|Baseline|Dose Escalation Phase|Participants received venetoclax in combination with a fixed dose of trastuzumab emtansine.
11371611|NCT04298918|BG001|Baseline|Dose Expansion Phase|Participants were to receive venetoclax at the Phase II Recommended Dose (RP2D) in combination with trastuzumab emtansine.
11371612|NCT04298918|BG002|Baseline|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371613|NCT04298918|BG003|Baseline|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11371614|NCT04298918|BG004|Baseline|Total|Total of all reporting groups
11371615|NCT04298918|FG000|Participant Flow|Dose Escalation Phase|Participants received venetoclax in combination with a fixed dose of trastuzumab emtansine.
11371616|NCT04298918|FG001|Participant Flow|Dose Expansion Phase|Participants were to receive venetoclax at the Phase II Recommended Dose (RP2D) in combination with trastuzumab emtansine.
11371617|NCT04298918|FG002|Participant Flow|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371618|NCT04298918|FG003|Participant Flow|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11371619|NCT04298918|OG000|Outcome|Dose Escalation Phase|Participants received venetoclax in combination with a fixed dose of trastuzumab emtansine.
11371620|NCT04298918|OG000|Outcome|Dose Expansion Phase|Participants were to receive venetoclax at the Phase II Recommended Dose (RP2D) in combination with trastuzumab emtansine.
11371621|NCT04298918|OG000|Outcome|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371622|NCT04298918|OG001|Outcome|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11371623|NCT04298918|OG001|Outcome|Dose Expansion Phase|Participants were to receive venetoclax at the Phase II Recommended Dose (RP2D) in combination with trastuzumab emtansine.
11371624|NCT04298918|OG002|Outcome|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371625|NCT04298918|OG003|Outcome|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11371626|NCT04298918|OG001|Outcome|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371627|NCT04298918|OG002|Outcome|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11190092|NCT02123485|FG001|Participant Flow|Sham- Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS)|"Sham right prefrontal rTMS 2 times a week~Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT."
11371628|NCT04298918|EG000|Reported Event|Dose Escalation Phase|Participants received venetoclax in combination with a fixed dose of trastuzumab emtansine.
11371629|NCT04298918|EG001|Reported Event|Dose Expansion Phase|Participants were to receive venetoclax at the Phase II Recommended Dose (RP2D) in combination with trastuzumab emtansine.
11371630|NCT04298918|EG002|Reported Event|Randomized Phase II Arm 1|Participants were to receive trastuzumab emtansine + placebo.
11371631|NCT04298918|EG003|Reported Event|Randomized Phase II Arm 2|Participants were to receive trastuzumab emtansine + venetoclax.
11371632|NCT01996371|BG000|Baseline|Group 1|"Unilateral pedicle screws~Pedicle Screw"
11371633|NCT01996371|BG001|Baseline|Group 2|"Ipsilateral pedicle screws, contralateral facet screw~Pedicle Screw"
11371634|NCT01996371|BG002|Baseline|Group 3|"Bilateral pedicle screws~Pedicle Screw"
11371635|NCT01996371|BG003|Baseline|Total|Total of all reporting groups
11371636|NCT01996371|FG000|Participant Flow|Group 1: Unilateral|"Unilateral pedicle screws~Pedicle Screw"
11371637|NCT01996371|FG001|Participant Flow|Group 2: Ipsilateral|"Ipsilateral pedicle screws, contralateral facet screw~Pedicle Screw"
11371638|NCT01996371|FG002|Participant Flow|Group 3: Bilateral|"Bilateral pedicle screws~Pedicle Screw"
11371639|NCT01996371|OG000|Outcome|Group 1|"Unilateral pedicle screws~Pedicle Screw"
11371640|NCT01996371|OG001|Outcome|Group 2|"Ipsilateral pedicle screws, contralateral facet screw~Pedicle Screw"
11371641|NCT01996371|OG002|Outcome|Group 3|"Bilateral pedicle screws~Pedicle Screw"
11371642|NCT01996371|OG000|Outcome|Group 1: Unilateral|"Unilateral pedicle screws~Pedicle Screw"
11371643|NCT01996371|OG001|Outcome|Group 2: Ipsilateral|"Ipsilateral pedicle screws, contralateral facet screw~Pedicle Screw"
11371644|NCT01996371|OG002|Outcome|Group 3: Bilateral|"Bilateral pedicle screws~Pedicle Screw"
11371645|NCT01996371|EG000|Reported Event|Group 1|"Unilateral pedicle screws~Pedicle Screw"
11371646|NCT01996371|EG001|Reported Event|Group 2|"Ipsilateral pedicle screws, contralateral facet screw~Pedicle Screw"
11371647|NCT01996371|EG002|Reported Event|Group 3|"Bilateral pedicle screws~Pedicle Screw"
11371648|NCT01561378|BG000|Baseline|Insulin|"Aspart Insulin 40 IU intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Aspart insulin: 40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371649|NCT01561378|BG001|Baseline|Normal Saline|"Normal saline (0.9% sodium chloride solution) intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Normal saline: 200 microliters of normal saline will be administered per nostril using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371650|NCT01561378|BG002|Baseline|Total|Total of all reporting groups
11371651|NCT01561378|FG000|Participant Flow|Insulin|"Aspart Insulin 40 IU intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Aspart insulin: 40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371652|NCT01561378|FG001|Participant Flow|Normal Saline|"Normal saline (0.9% sodium chloride solution) intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Normal saline: 200 microliters of normal saline will be administered per nostril using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371653|NCT01561378|OG000|Outcome|Insulin|"Aspart Insulin 40 IU intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Aspart insulin: 40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371654|NCT01561378|OG001|Outcome|Normal Saline|"Normal saline (0.9% sodium chloride solution) intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Normal saline: 200 microliters of normal saline will be administered per nostril using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
10850061|NCT00300053|FG002|Participant Flow|Placebo Control|Intramyocardial placebo injections
10850062|NCT00300053|OG000|Outcome|CLBS14: Low-Dose Group|Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
10850063|NCT00300053|OG001|Outcome|CLBS14: High-Dose Group|Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
10850064|NCT00300053|OG002|Outcome|Placebo Control|Intramyocardial placebo injections
11371655|NCT01561378|EG000|Reported Event|Insulin|"Aspart Insulin 40 IU intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Aspart insulin: 40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371656|NCT01561378|EG001|Reported Event|Normal Saline|"Normal saline (0.9% sodium chloride solution) intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first~Normal saline: 200 microliters of normal saline will be administered per nostril using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)~Intranasal mucosal atomizer device: Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity."
11371657|NCT00955929|BG000|Baseline|PRN Sildenafil|"Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.~Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
10850065|NCT00300053|EG000|Reported Event|CLBS14: Low-Dose Group|Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
10850066|NCT00300053|EG001|Reported Event|CLBS14: High-Dose Group|Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
10850067|NCT00300053|EG002|Reported Event|Placebo Control|Intramyocardial placebo injections
10850068|NCT00300053|EG003|Reported Event|No Cell or Placebo Injection|Cell mobilization with G-CSF started but no cell or placebo injection administered
11190093|NCT02123485|OG000|Outcome|Low Frequency rTMS|"Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week~Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT."
11190094|NCT02123485|OG001|Outcome|Sham-rTMS|"Sham right prefrontal rTMS 2 times a week~Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT."
11190095|NCT02123485|EG000|Reported Event|Low Frequency rTMS|"Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week~Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT."
11371658|NCT00955929|BG001|Baseline|Nightly Sildenafil Arm|"Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.~Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window"
11371659|NCT00955929|BG002|Baseline|Combination Therapy Arm|"Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).~Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11371660|NCT00955929|BG003|Baseline|Total|Total of all reporting groups
11371661|NCT00955929|FG000|Participant Flow|PRN Sildenafil|"Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.~Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11190096|NCT02123485|EG001|Reported Event|Sham-rTMS|"Sham right prefrontal rTMS 2 times a week~Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT."
11190097|NCT02123511|BG000|Baseline|Arm A (Placebo)|Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190098|NCT02123511|BG001|Baseline|Arm B (Rincinol)|Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190099|NCT02123511|BG002|Baseline|Total|Total of all reporting groups
11190100|NCT02123511|FG000|Participant Flow|Arm A (Placebo)|Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190101|NCT02123511|FG001|Participant Flow|Arm B (Rincinol)|Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190102|NCT02123511|OG000|Outcome|Arm A (Placebo)|Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190103|NCT02123511|OG001|Outcome|Arm B (Rincinol)|Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11371662|NCT00955929|FG001|Participant Flow|Nightly Sildenafil Arm|"Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.~Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window"
11376331|NCT00602459|FG001|Participant Flow|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
11190104|NCT02123511|EG000|Reported Event|Arm A (Placebo)|Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190105|NCT02123511|EG001|Reported Event|Arm B (Rincinol)|Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
11190106|NCT02123576|BG000|Baseline|Treatment|"Pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR <10 for 90 days in addition to standard AMO therapy~Pentoxyfylline~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11190107|NCT02123576|BG001|Baseline|Placebo|"This is a standard placebo pill.~Placebo~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11190108|NCT02123576|BG002|Baseline|Total|Total of all reporting groups
11190109|NCT02123576|FG000|Participant Flow|Treatment|"Pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR <10 for 90 days in addition to standard AMO therapy~Pentoxyfylline~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11190110|NCT02123576|FG001|Participant Flow|Placebo|"This is a standard placebo pill.~Placebo~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11371663|NCT00955929|FG002|Participant Flow|Combination Therapy Arm|"Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).~Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11371664|NCT00955929|OG000|Outcome|PRN Sildenafil|"Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.~Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11371665|NCT00955929|OG001|Outcome|Nightly Sildenafil Arm|"Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.~Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window"
11371666|NCT00955929|OG002|Outcome|Combination Therapy Arm|"Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).~Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11371667|NCT00955929|EG000|Reported Event|PRN Sildenafil|"Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.~Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11371668|NCT00955929|EG001|Reported Event|Nightly Sildenafil Arm|"Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.~Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window"
11371669|NCT00955929|EG002|Reported Event|Combination Therapy Arm|"Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).~Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window."
11376332|NCT00602459|FG002|Participant Flow|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
10850069|NCT00300235|BG000|Baseline|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850070|NCT00300235|BG001|Baseline|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
10850071|NCT00300235|BG002|Baseline|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850072|NCT00300235|BG003|Baseline|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
10850073|NCT00300235|BG004|Baseline|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
10850074|NCT00300235|BG005|Baseline|Total|Total of all reporting groups
10850075|NCT00300235|FG000|Participant Flow|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
11371670|NCT00402883|BG000|Baseline|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
11371671|NCT00402883|FG000|Participant Flow|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.~Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
11371672|NCT00402883|OG000|Outcome|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
11371673|NCT00402883|OG000|Outcome|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.~Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
11371674|NCT00402883|EG000|Reported Event|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
11371675|NCT03482505|BG000|Baseline|INVSENSOR00004|"All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).~INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate."
11371676|NCT03482505|FG000|Participant Flow|INVSENSOR00004|"All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).~INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate."
11371677|NCT03482505|OG000|Outcome|INVSENSOR00004|"All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).~INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate."
11371678|NCT03482505|EG000|Reported Event|INVSENSOR00004|"All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).~INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate."
11376333|NCT00602459|FG003|Participant Flow|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
11337272|NCT03582215|FG007|Participant Flow|Part 2: Pump Spray|"Part 2: Pump Spray:~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
10850076|NCT00300235|FG001|Participant Flow|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
11337273|NCT03582215|OG000|Outcome|Part 1: Cream|"Part 1: Cream:~Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337274|NCT03582215|OG001|Outcome|Part 1: Lotion|"Part 1: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337275|NCT03582215|OG002|Outcome|Part 1: Spray 1|"Part 1: Spray 1:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337276|NCT03582215|OG003|Outcome|Part 1: Spray 2|"Part 1: Spray 2:~Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337277|NCT03582215|OG004|Outcome|Part 2: Lotion|"Part 2: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337278|NCT03582215|OG005|Outcome|Part 2: Aerosol Spray|"Part 2: Aerosol Spray:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337279|NCT03582215|OG006|Outcome|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray:~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337280|NCT03582215|OG007|Outcome|Part 2: Pump Spray|"Part 2: Pump Spray:~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337281|NCT03582215|OG000|Outcome|Part 1: Lotion|"Part 1: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337282|NCT03582215|OG001|Outcome|Part 1: Spray 1|"Part 1: Spray 1:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337283|NCT03582215|OG002|Outcome|Part 1: Spray 2|"Part 1: Spray 2:~Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337284|NCT03582215|OG003|Outcome|Part 2: Lotion|"Part 2: Lotion:~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337285|NCT03582215|OG004|Outcome|Part 2: Aerosol Spray|"Part 2: Aerosol Spray:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337286|NCT03582215|OG000|Outcome|Part 1: Spray 1|"Part 1: Spray 1:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337287|NCT03582215|OG001|Outcome|Part 2: Aerosol Spray|"Part 2: Aerosol Spray:~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337288|NCT03582215|OG002|Outcome|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray:~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337289|NCT03582215|OG003|Outcome|Part 2: Pump Spray|"Part 2: Pump Spray:~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337290|NCT03582215|OG000|Outcome|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray:~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337291|NCT03582215|OG001|Outcome|Part 2: Pump Spray|"Part 2: Pump Spray:~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337292|NCT03582215|EG000|Reported Event|Part 1: Cream|"Part 1: Cream~Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11371679|NCT02934503|BG000|Baseline|Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation|"Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.~Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.~Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.~Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years.~Pembrolizumab: 200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.~Cisplatin: 75 mg/m2~Carboplatin: AUC 6~Etoposide: IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).~Radiation therapy: Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants)."
11371680|NCT02934503|FG000|Participant Flow|Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation|"Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.~Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.~Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.~Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years.~Pembrolizumab: 200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.~Cisplatin: 75 mg/m2~Carboplatin: AUC 6~Etoposide: IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).~Radiation therapy: Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants)."
11371681|NCT02934503|OG000|Outcome|Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation|"Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.~Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.~Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.~Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years.~Pembrolizumab: 200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.~Cisplatin: 75 mg/m2~Carboplatin: AUC 6~Etoposide: IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).~Radiation therapy: Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants)."
11371682|NCT02934503|EG000|Reported Event|Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation|"Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.~Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.~Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.~Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years.~Pembrolizumab: 200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.~Cisplatin: 75 mg/m2~Carboplatin: AUC 6~Etoposide: IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).~Radiation therapy: Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants)."
11371683|NCT02137252|BG000|Baseline|Naltrexone|The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
11371684|NCT02137252|BG001|Baseline|Placebo: Sugar Pill|daily dose placebo for 5 week treatment period
11371685|NCT02137252|BG002|Baseline|Total|Total of all reporting groups
11371686|NCT02137252|FG000|Participant Flow|Naltrexone|The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
11371687|NCT02137252|FG001|Participant Flow|Sugar Pill|daily dose placebo for 5 week treatment period
11371688|NCT02137252|OG000|Outcome|Naltrexone|"The treatment schedule includes a daily dose of naltrexone for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.~Naltrexone"
11371689|NCT02137252|OG001|Outcome|Sugar Pill|"The treatment schedule includes a daily dose of equivalent placebo for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.~Sugar Pill"
11371690|NCT02137252|EG000|Reported Event|Naltrexone|The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
11371691|NCT02137252|EG001|Reported Event|Sugar Pill|daily dose placebo for 5 week treatment period
11371692|NCT03863522|BG000|Baseline|Fine Needle Aspiration|"Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).~Fine needle aspiration: Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.~Cancer Detection cartridge: The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis."
11371693|NCT03863522|FG000|Participant Flow|Fine Needle Aspiration|"Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).~Fine needle aspiration: Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.~Cancer Detection cartridge: The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis."
11371694|NCT03863522|OG000|Outcome|Fine Needle Aspiration|"Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).~Fine needle aspiration: Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.~Cancer Detection cartridge: The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis."
11371695|NCT03863522|EG000|Reported Event|Fine Needle Aspiration|"Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).~Fine needle aspiration: Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.~Cancer Detection cartridge: The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis."
11371696|NCT01294670|BG000|Baseline|Dose Level 1|100 mg/m2 Etoposide, 125 mg/m2 Vorinostat + Data Migration
11371697|NCT01294670|BG001|Baseline|Dose Level 2|100 mg/m2 Etoposide, 160 mg/m2 Vorinostat + Data Migration
11371698|NCT01294670|BG002|Baseline|Dose Level 3|100 mg/m2 Etoposide, 210 mg/m2 Vorinostat + Data Migration
11371699|NCT01294670|BG003|Baseline|Dose Level 4|100 mg/m2 Etoposide, 270 mg/m2 Vorinostat + Data Migration
11371700|NCT01294670|BG004|Baseline|Phase II Dose|Vorinostat 270 mg/m2; Etoposide 100 mg/m2 + Data Migration
11371701|NCT01294670|BG005|Baseline|Total|Total of all reporting groups
11371702|NCT01294670|FG000|Participant Flow|Dose Level 1|100 mg/m2 Etoposide, 125 mg/m2 Vorinostat + Data Migration
11371703|NCT01294670|FG001|Participant Flow|Dose Level 2|100 mg/m2 Etoposide, 160 mg/m2 Vorinostat + Data Migration
11371704|NCT01294670|FG002|Participant Flow|Dose Level 3|100 mg/m2 Etoposide, 210 mg/m2 Vorinostat + Data Migration
11371705|NCT01294670|FG003|Participant Flow|Dose Level 4|100 mg/m2 Etoposide, 270 mg/m2 Vorinostat + Data Migration
11371706|NCT01294670|FG004|Participant Flow|Phase II|Vorinostat 270 mg/m2; Etoposide 100 mg/m2 + Data Migration
11371707|NCT01294670|OG000|Outcome|Dose Level 1|100 mg/m2 Etoposide, 125 mg/m2 Vorinostat (n=7)
11371708|NCT01294670|OG001|Outcome|Dose Level 2|100 mg/m2 Etoposide, 160 mg/m2 Vorinostat (n=3)
11371709|NCT01294670|OG002|Outcome|Dose Level 3|100 mg/m2 Etoposide, 210 mg/m2 Vorinostat (n=3)
11371710|NCT01294670|OG003|Outcome|Dose Level 4|100 mg/m2 Etoposide, 270 mg/m2 Vorinostat (n=9)
11371711|NCT01294670|OG004|Outcome|Phase II Dose|Vorinostat 270 mg/m2; Etoposide 100 mg/m2 (n=5)
11371712|NCT01294670|EG000|Reported Event|Dose Level 1|100 mg/m2 Etoposide, 125 mg/m2 Vorinostat (n=7)
11371713|NCT01294670|EG001|Reported Event|Dose Level 2|100 mg/m2 Etoposide, 160 mg/m2 Vorinostat (n=3)
10850077|NCT00300235|FG002|Participant Flow|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850078|NCT00300235|FG003|Participant Flow|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
11371714|NCT01294670|EG002|Reported Event|Dose Level 3|100 mg/m2 Etoposide, 210 mg/m2 Vorinostat (n=3)
11371715|NCT01294670|EG003|Reported Event|Dose Level 4|100 mg/m2 Etoposide, 270 mg/m2 Vorinostat (n=9)
11371716|NCT01294670|EG004|Reported Event|Phase II Dose|Vorinostat 270 mg/m2; Etoposide 100 mg/m2 (n=5)
11371717|NCT03095287|BG000|Baseline|Alphanate|Participants entered the immune tolerance induction (ITI) phase and received alphanate IV at a starting dose of 100 IU/kg/day. Dose could be uptitrated to 200 IU/kg/day based on investigator's discretion. The maximum duration of treatment was 32 months and 2 weeks.
11371718|NCT03095287|FG000|Participant Flow|Alphanate|Participants entered the immune tolerance induction (ITI) phase and received alphanate IV at a starting dose of 100 IU/kg/day. Dose could be uptitrated to 200 IU/kg/day based on investigator's discretion. The maximum duration of treatment was 32 months and 2 weeks.
11371719|NCT03095287|OG000|Outcome|Alphanate|Participants entered the immune tolerance induction (ITI) phase and received alphanate IV at a starting dose of 100 IU/kg/day. Dose could be uptitrated to 200 IU/kg/day based on investigator's discretion. The maximum duration of treatment was 32 months and 2 weeks.
11371720|NCT03095287|EG000|Reported Event|Alphanate|Participants entered the ITI phase and received alphanate IV at a starting dose of 100 IU/kg/day. Dose could be uptitrated to 200 IU/kg/day based on investigator's discretion. The maximum duration of treatment was 32 months and 2 weeks.
11371721|NCT03236662|BG000|Baseline|Treatment|"(-)-epicatechin 50mg twice per day (100mg per day total dose)~(-)-Epicatechin"
11371722|NCT03236662|FG000|Participant Flow|Treatment|"(-)-epicatechin 50mg twice per day (100mg per day total dose)~(-)-Epicatechin"
11371723|NCT03236662|OG000|Outcome|Treatment|"(-)-epicatechin 50mg twice per day (100mg per day total dose)~(-)-Epicatechin"
11371724|NCT03236662|EG000|Reported Event|Treatment|"(-)-epicatechin 50mg twice per day (100mg per day total dose)~(-)-Epicatechin"
11371725|NCT02930122|BG000|Baseline|Arm 1|"Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury~anakinra (150mg): intraarticular administration"
11371726|NCT02930122|BG001|Baseline|Placebo Control|"Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury~Saline intraarticularly: intraarticular administration"
11371727|NCT02930122|BG002|Baseline|Total|Total of all reporting groups
11371728|NCT02930122|FG000|Participant Flow|Anakinra|"Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury~anakinra (150mg): intraarticular administration"
11371729|NCT02930122|FG001|Participant Flow|Placebo Control|"Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury~Saline intraarticularly: intraarticular administration"
11371730|NCT02930122|OG000|Outcome|Arm 1|"Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury~anakinra (150mg): intraarticular administration"
11371731|NCT02930122|OG001|Outcome|Placebo Control|"Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury~Saline intraarticularly: intraarticular administration"
11371732|NCT02930122|OG000|Outcome|Anakinra|"Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury~anakinra (150mg): intraarticular administration"
11371733|NCT02930122|EG000|Reported Event|Arm 1|"Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury~anakinra (150mg): intraarticular administration"
11371734|NCT02930122|EG001|Reported Event|Placebo Control|"Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury~Saline intraarticularly: intraarticular administration"
11371735|NCT01444209|BG000|Baseline|Radiation Therapy|"Interstitial Radioactive Iodine Implants~Iodine Implants: Interstitial Radioactive Iodine Implants"
11371736|NCT01444209|FG000|Participant Flow|Radiation Therapy|"Interstitial Radioactive Iodine Implants~Iodine Implants: Interstitial Radioactive Iodine Implants"
11371737|NCT01444209|OG000|Outcome|Radiation Therapy|"Interstitial Radioactive Iodine Implants~Iodine Implants: Interstitial Radioactive Iodine Implants"
11371738|NCT01444209|EG000|Reported Event|Radiation Therapy|"Interstitial Radioactive Iodine Implants~Iodine Implants: Interstitial Radioactive Iodine Implants"
11371739|NCT04267380|BG000|Baseline|Tofacitinib Modified Release (MR) 11mg QD|Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371740|NCT04267380|BG001|Baseline|Tofacitinib Immediate Release (IR) 5 mg BID|Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, BID, on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371741|NCT04267380|BG002|Baseline|Total|Total of all reporting groups
11371742|NCT04267380|FG000|Participant Flow|Tofacitinib Modified Release (MR) 11mg QD|Participants with RA who initiated Tofacitinib 11 milligram (mg) MR tablet, orally, once daily (QD), after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371743|NCT04267380|FG001|Participant Flow|Tofacitinib Immediate Release (IR) 5 mg BID|Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, twice daily (BID), on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371744|NCT04267380|OG000|Outcome|Tofacitinib Modified Release (MR) 11mg QD|Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11190111|NCT02123576|OG000|Outcome|Treatment|"Pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR <10 for 90 days in addition to standard AMO therapy~Pentoxyfylline~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11190112|NCT02123576|OG001|Outcome|Placebo|"This is a standard placebo pill.~Placebo~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11190113|NCT02123576|EG000|Reported Event|Treatment|"Pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR <10 for 90 days in addition to standard AMO therapy~Pentoxyfylline~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11371745|NCT04267380|OG001|Outcome|Tofacitinib Immediate Release (IR) 5 mg BID|Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, BID, on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371746|NCT04267380|EG000|Reported Event|Tofacitinib Modified Release (MR) 11mg QD|Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371747|NCT04267380|EG001|Reported Event|Tofacitinib Immediate Release (IR) 5 mg BID|Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, BID, on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.
11371748|NCT04144166|BG000|Baseline|All Subjects|"Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.~Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by start compression and release compression beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.~CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement."
11371749|NCT04144166|FG000|Participant Flow|All Subjects|"Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.~Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by start compression and release compression beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.~CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement."
11371750|NCT04144166|OG000|Outcome|Sensitivity and Specificity to Predict Low Peripheral Perfusion|Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (> 2 s) and very low CRT (> 3 s)
11371751|NCT04144166|OG000|Outcome|Correlation Between CRI and CRT Values|Spearman's correlation method to determine relationship between median device CRI and median device CRT measurements.
11371752|NCT04144166|OG000|Outcome|All Subject >= 60 Years|All subject >= 60 years
11190114|NCT02123576|EG001|Reported Event|Placebo|"This is a standard placebo pill.~Placebo~AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS)"
11371753|NCT04144166|OG001|Outcome|All Subjects < 60 Years|All subjects < 60 years
10850079|NCT00300235|FG004|Participant Flow|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
10850080|NCT00300235|OG000|Outcome|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850081|NCT00300235|OG001|Outcome|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
10850082|NCT00300235|OG002|Outcome|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850083|NCT00300235|OG003|Outcome|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
10850084|NCT00300235|OG004|Outcome|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
10850085|NCT00300235|EG000|Reported Event|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850086|NCT00300235|EG001|Reported Event|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
10850087|NCT00300235|EG002|Reported Event|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
10850088|NCT00300235|EG003|Reported Event|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
10850089|NCT00300235|EG004|Reported Event|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
10850090|NCT00300274|BG000|Baseline|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
11190115|NCT02123745|BG000|Baseline|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
11337293|NCT03582215|EG001|Reported Event|Part 1: Lotion|"Part 1: Lotion~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337294|NCT03582215|EG002|Reported Event|Part 1: Spray 1|"Part 1: Spray 1~Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337295|NCT03582215|EG003|Reported Event|Part 1: Spray 2|"Part 1: Spray 2~Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area"
11337296|NCT03582215|EG004|Reported Event|Part 2: Lotion|"Part 2: Lotion~Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337297|NCT03582215|EG005|Reported Event|Part 2: Aerosol Spray|"Part 2: Aerosol Spray~Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337298|NCT03582215|EG006|Reported Event|Part 2: Nonaerosol Spray|"Part 2: Nonaerosol Spray~Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337299|NCT03582215|EG007|Reported Event|Part 2: Pump Spray|"Part 2: Pump Spray~Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate~Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area"
11337300|NCT03582553|BG000|Baseline|Cohort 1: NAR150, Placebo, NAR300|Cohort 1 Sequence 1: NAR150 first, then Placebo, then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337301|NCT03582553|BG001|Baseline|Cohort 1: NAR150, NAR300, Placebo|Cohort 1 Sequence 2: NAR150 first, then NAR300 and then Placebo. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337302|NCT03582553|BG002|Baseline|Cohort 1: Placebo, NAR150, NAR300|Cohort 1 Sequence 3: Placebo first, then NAR150, and then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337303|NCT03582553|BG003|Baseline|Cohort 2. NAR600, Placebo, NAR900|Cohort 2 Sequence 1: NAR600, then Placebo, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337304|NCT03582553|BG004|Baseline|Cohort 2: NAR600, NAR900, Placebo|Cohort 2 Sequence 2: NAR600, then NAR900, and then Placebo. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337305|NCT03582553|BG005|Baseline|Cohort 2: Placebo, NAR600, NAR900|Cohort 2 Sequence 3: Placebo, NAR600, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337306|NCT03582553|BG006|Baseline|Total|Total of all reporting groups
11337307|NCT03582553|FG000|Participant Flow|Cohort 1: NAR150, Placebo, NAR300|Cohort 1 Sequence 1: NAR150 first, then Placebo, then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337308|NCT03582553|FG001|Participant Flow|Cohort 1: NAR150, NAR300, Placebo,|Cohort 1 Sequence 2: NAR150 first, then NAR300 and then Placebo. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11337309|NCT03582553|FG002|Participant Flow|Cohort 1: Placebo, NAR150, NAR300|Cohort 1 Sequence 3: Placebo first, then NAR150, and then NAR300. 150 and 300 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 300 mg (NAR300) naringenin doses were provided in two capsules. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11190116|NCT02123745|FG000|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
11190117|NCT02123745|OG000|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
11190118|NCT02123745|EG000|Reported Event|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
11190119|NCT02123797|BG000|Baseline|Multidisciplinary Clinic Patients|150 multidisciplinary clinic patients and their informal caregivers are seen by multiple specialists at a single appointment time.
11190120|NCT02123797|BG001|Baseline|Serial Care Patients|300 matched serial care control patients who receive the current system of linear, sequential, referral-based care delivery.
11190121|NCT02123797|BG002|Baseline|Total|Total of all reporting groups
11190122|NCT02123797|FG000|Participant Flow|Multidisciplinary Clinic Patients|For the multidisciplinary arm, patients and their informal caregivers are seen by multiple specialists at a single appointment time.
11190123|NCT02123797|FG001|Participant Flow|Serial Care Patients|For the serial care arm, matched serial care control patients receive the current system of linear, sequential, referral-based care delivery.
11190124|NCT02123797|FG002|Participant Flow|Multidisciplinary Caregivers|Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time).
11190125|NCT02123797|FG003|Participant Flow|Serial Care Caregivers|Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery).
11190126|NCT02123797|FG004|Participant Flow|Clinical Providers|Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study.
11190127|NCT02123797|OG000|Outcome|Multidisciplinary Clinic Patients|Patients seen and treated in the Multidisciplinary Clinic.
11190128|NCT02123797|OG001|Outcome|Serial Care Patients|Patients seen and treated in the standard, sequential-referral-based environment of care.
11190129|NCT02123797|OG001|Outcome|Serial Care Patients Presented in Conference|Serial care patients who were presented in the multidisciplinary conference but not seen in the multidisciplinary clinic.
11190130|NCT02123797|OG002|Outcome|Serial Care Patients Not Presented in Conference|Serial care patients who were not presented in the multidisciplinary conference.
11190131|NCT02123797|OG000|Outcome|Multidisciplinary Clinic Patients|Patients seen and treated in the Multidisciplinary Clinic
11190132|NCT02123797|OG002|Outcome|Overall Conference|All Patients presented in conference
11190133|NCT02123797|OG001|Outcome|Serial Care Conference Patients|Serial care patients who were presented in the multidisciplinary conference but not seen in the multidisciplinary clinic.
11190134|NCT02123797|OG000|Outcome|Multidisciplinary Clinic Caregivers|Multidisciplinary clinic informal caregivers of patients who are seen by multiple specialists at a single appointment time.
11190135|NCT02123797|OG001|Outcome|Serial Care Caregivers|Serial care control caregivers whose patients received the current system of linear, sequential, referral-based care delivery.
11190136|NCT02123797|OG000|Outcome|Multidisciplinary Clinic Caregivers|Multidisciplinary clinic caregivers of patients seen by multiple specialists at a single appointment time.
11190137|NCT02123797|OG001|Outcome|Serial Care Caregivers|Serial care control caregivers of patients who receive the current system of linear, sequential, referral-based care delivery.
11190138|NCT02123797|OG000|Outcome|Baseline|Clinical providers who referred more than 5 patients to the multidisciplinary program
11190139|NCT02123797|OG001|Outcome|6 Month Follow up|6-month follow up of clinical providers who referred more than 5 patients to the multidisciplinary program
11190140|NCT02123797|OG002|Outcome|12 Month Follow-up|12 month follow up of clinical providers who referred more than 5 patients to the multidisciplinary program
11190141|NCT02123797|OG000|Outcome|Multidisciplinary Clinic Patients|150 multidisciplinary clinic patients and their informal caregivers are seen by multiple specialists at a single appointment time.
11371754|NCT04144166|OG000|Outcome|All Subjects With Fitzpatrick Skin Tone Score of 1, 2 or 3|All subjects with FItzpatrick skin tone score of 1, 2 or 3
11371755|NCT04144166|OG001|Outcome|All Subjects With Fitzpatrick Skin Tone Score of 4, 5 or 6|All subjects with FItzpatrick skin tone score of 4, 5 or 6
11190142|NCT02123797|OG001|Outcome|Serial Care Patients|300 matched serial care control patients who receive the current system of linear, sequential, referral-based care delivery.
11190143|NCT02123797|EG000|Reported Event|Multidisciplinary Clinic Patients|Patients seen and treated in the Multidisciplinary Clinic.
11190144|NCT02123797|EG001|Reported Event|Serial Care Patients|Patients seen and treated in the standard, sequential-referral-based environment of care.
11190145|NCT02123849|BG000|Baseline|Arm I (Continuous Aspirin)|"Participants receive aspirin PO QD for 12 weeks.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11190146|NCT02123849|BG001|Baseline|Arm II (Intermittent Aspirin)|"Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
11190147|NCT02123849|BG002|Baseline|Total|Total of all reporting groups
11190148|NCT02123849|FG000|Participant Flow|Arm I (Continuous Aspirin)|"Participants receive aspirin PO QD for 12 weeks.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11190149|NCT02123849|FG001|Participant Flow|Arm II (Intermittent Aspirin)|"Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
11190150|NCT02123849|OG000|Outcome|Arm I (Continuous Aspirin)|"Participants receive aspirin PO QD for 12 weeks.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11190151|NCT02123849|OG001|Outcome|Arm II (Intermittent Aspirin)|"Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
11190152|NCT02123849|OG000|Outcome|Males (Overall)|Male participants receive continuous or intermittent PO dosing of aspirin for 12 weeks.
11190153|NCT02123849|OG001|Outcome|Females (Overall)|Female participants receive continuous or intermittent PO dosing of aspirin for 12 weeks
11190154|NCT02123849|EG000|Reported Event|Arm I (Continuous Aspirin)|"Participants receive aspirin PO QD for 12 weeks.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11190155|NCT02123849|EG001|Reported Event|Arm II (Intermittent Aspirin)|"Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
11190156|NCT02123966|BG000|Baseline|Topical Sirolimus + Steroid|A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards.
11190157|NCT02123966|FG000|Participant Flow|Topical Sirolimus + Steroid|A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards.
11190158|NCT02123966|OG000|Outcome|Topical Sirolimus + Steroid|A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards.
11337310|NCT03582553|FG003|Participant Flow|Cohort 2. NAR600, Placebo, NAR900|Cohort 2 Sequence 1: NAR600, then Placebo, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
11240363|NCT02478372|FG001|Participant Flow|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
11240364|NCT02478372|OG000|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
11240365|NCT02478372|OG001|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
11240366|NCT02478372|EG000|Reported Event|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
11240367|NCT02478372|EG001|Reported Event|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
11240368|NCT02478398|BG000|Baseline|Short Ragweed Pollen Allergen Extract|Participants received one short ragweed pollen allergen extract sublingual tablet containing 12 units of Amb a 1-U, QD for up to 35 weeks.
11240369|NCT02478398|BG001|Baseline|Placebo|Participants received one placebo sublingual tablet, QD for up to 35 weeks.
11240370|NCT02478398|BG002|Baseline|Total|Total of all reporting groups
11240371|NCT02478398|FG000|Participant Flow|Short Ragweed Pollen Allergen Extract|Participants received one short ragweed pollen allergen extract sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.
11240372|NCT02478398|FG001|Participant Flow|Placebo|Participants received one placebo sublingual tablet, QD for up to 35 weeks.
11240373|NCT02478398|OG000|Outcome|Short Ragweed Pollen Allergen Extract|Participants received one short ragweed pollen allergen extract sublingual tablet containing 12 units of Amb a 1-U, QD for up to 35 weeks.
11240374|NCT02478398|OG001|Outcome|Placebo|Participants received one placebo sublingual tablet, QD for up to 35 weeks.
11240375|NCT02478398|OG000|Outcome|Short Ragween Pollen Allergen Extract|Participants received one short ragweed pollen allergen extract sublingual tablet containing 12 units of Amb a 1-U, QD for up to 35 weeks.
11240376|NCT02478398|EG000|Reported Event|Short Ragweed Pollen Allergen Extract|Participants received one short ragweed pollen allergen extract sublingual tablet containing 12 units of Amb a 1-U, QD for up to 35 weeks.
11240377|NCT02478398|EG001|Reported Event|Placebo|Participants received one placebo sublingual tablet, QD for up to 35 weeks.
11240378|NCT02478463|BG000|Baseline|Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg|Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.
11240379|NCT02478463|FG000|Participant Flow|Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg|Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.
11240380|NCT02478463|OG000|Outcome|Cabotegravir IM 600 mg|All participants received single IM dose of 600 mg cabotegravir in Period 2.
11240381|NCT02478463|OG000|Outcome|Cabotegravir Oral 30 mg|All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.
11240382|NCT02478463|EG000|Reported Event|Cabotegravir Oral 30 mg|All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.
11240383|NCT02478463|EG001|Reported Event|Cabotegravir IM 600 mg|All participants received single IM dose of 600 mg cabotegravir in Period 2.
11240384|NCT02478489|BG000|Baseline|Extended-release Injectable Naltrexone (XR-NTX)|"Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.~Extended-release injectable naltrexone (XR-NTX): injectable naltrexone"
11240385|NCT02478489|BG001|Baseline|Oral Naltrexone (PO-NTX)|"Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.~Oral naltrexone (PO-NTX): oral naltrexone"
11240386|NCT02478489|BG002|Baseline|Total|Total of all reporting groups
11240387|NCT02478489|FG000|Participant Flow|Extended-release Injectable Naltrexone (XR-NTX)|"Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.~Extended-release injectable naltrexone (XR-NTX): injectable naltrexone"
11240388|NCT02478489|FG001|Participant Flow|Oral Naltrexone (PO-NTX)|"Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.~Oral naltrexone (PO-NTX): oral naltrexone"
11371756|NCT04144166|EG000|Reported Event|All Subjects|"Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.~Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by start compression and release compression beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.~CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement."
11371757|NCT04090164|BG000|Baseline|Study Group|Randomly selected data of 405 patients treated within the last ten years at the study site.
11371758|NCT04090164|BG001|Baseline|Dakahlia Governorate Adult Female Population|A historical control group derived from the raw data of a previously published study (PMID: 31463388, PMCID: PMC6709406, DOI: 10.1016/j.heliyon.2019.e02249)
11371759|NCT04090164|BG002|Baseline|Total|Total of all reporting groups
11371760|NCT04090164|FG000|Participant Flow|Study Group|The data of breast cancer patients treated at OCMU in the last 10 years will be retrieved from the hospital data filing system. All consecutive patients with biopsy-proven invasive breast cancer will be included.
11371761|NCT04090164|FG001|Participant Flow|Dakahlia Governorate Adult Female Population|"One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.~[El-Ghitany EM, Farghaly AG (2019) Geospatial epidemiology of hepatitis C infection in Egypt 2017 by governorate. Heliyon 5 (8):e02249. doi:10.1016/j.heliyon.2019.e02249}"
11371762|NCT04090164|OG000|Outcome|Study Group|Randomly selected data of 405 patients treated within the last ten years at the study site.
11371763|NCT04090164|OG001|Outcome|Dakahlia Governorate Adult Female Population|One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.
11371764|NCT04090164|OG000|Outcome|Anti-HCV Positive Patients|patients with anti-HCV positive test.
11371765|NCT04090164|OG001|Outcome|Anti-HCV Negative Patients|patients with anti-HCV negative test.
11371766|NCT04090164|EG000|Reported Event|Study Group|All-cause Mortality and Adverse Events were not assessed in this retrospective, observational study
11371767|NCT04047121|BG000|Baseline|Tofacitinib Low OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database.
11371768|NCT04047121|BG001|Baseline|Tofacitinib High OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases.
11371769|NCT04047121|BG002|Baseline|Switch From Adalimumab to Etanercept|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases.
11371770|NCT04047121|BG003|Baseline|Switch From Adalimumab to Tofacitinib|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases.
11371771|NCT04047121|BG004|Baseline|Switch From Etanercept to Adalimumab|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases.
11371772|NCT04047121|BG005|Baseline|Switch From Etanercept to Tofacitinib|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
11371773|NCT04047121|BG006|Baseline|Total|Total of all reporting groups
11371774|NCT04047121|FG000|Participant Flow|Tofacitinib Low Out of Pocket (OOP) Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database.
11371775|NCT04047121|FG001|Participant Flow|Tofacitinib High OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases.
11371776|NCT04047121|FG002|Participant Flow|Switch From Adalimumab to Etanercept|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases.
11371777|NCT04047121|FG003|Participant Flow|Switch From Adalimumab to Tofacitinib|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases.
11371778|NCT04047121|FG004|Participant Flow|Switch From Etanercept to Adalimumab|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases.
11371779|NCT04047121|FG005|Participant Flow|Switch From Etanercept to Tofacitinib|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
11371780|NCT04047121|OG000|Outcome|Tofacitinib Low OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database.
11371781|NCT04047121|OG001|Outcome|Tofacitinib High OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases.
11371782|NCT04047121|OG002|Outcome|Switch From Adalimumab to Etanercept|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases.
11371783|NCT04047121|OG003|Outcome|Switch From Adalimumab to Tofacitinib|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases.
11371784|NCT04047121|OG004|Outcome|Switch From Etanercept to Adalimumab|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases.
11371785|NCT04047121|OG005|Outcome|Switch From Etanercept to Tofacitinib|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
11371786|NCT04047121|EG000|Reported Event|Tofacitinib Low OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database.
10962818|NCT00868608|FG000|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent Non-Hodgkin's Lymphoma (NHL) defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 percent [%] of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11371787|NCT04047121|EG001|Reported Event|Tofacitinib High OOP Cost|Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases.
11371788|NCT04047121|EG002|Reported Event|Switch From Adalimumab to Etanercept|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases.
11371789|NCT04047121|EG003|Reported Event|Switch From Adalimumab to Tofacitinib|Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases.
11371790|NCT04047121|EG004|Reported Event|Switch From Etanercept to Adalimumab|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases.
11371791|NCT04047121|EG005|Reported Event|Switch From Etanercept to Tofacitinib|Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
10850091|NCT00300274|BG001|Baseline|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
11371792|NCT04018001|BG000|Baseline|Tofacitinib Modified Release (MR)|Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371793|NCT04018001|BG001|Baseline|Tofacitinib Immediate Release (IR)|Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371794|NCT04018001|BG002|Baseline|Total|Total of all reporting groups
11371795|NCT04018001|FG000|Participant Flow|Tofacitinib Modified Release (MR)|Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371796|NCT04018001|FG001|Participant Flow|Tofacitinib Immediate Release (IR)|Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371797|NCT04018001|OG000|Outcome|Tofacitinib Modified Release (MR)|Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371798|NCT04018001|OG001|Outcome|Tofacitinib Immediate Release (IR)|Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371799|NCT04018001|EG000|Reported Event|Tofacitinib Modified Release (MR)|Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371800|NCT04018001|EG001|Reported Event|Tofacitinib Immediate Release (IR)|Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
11371801|NCT04017754|BG000|Baseline|Study Sample|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases."
11371802|NCT04017754|FG000|Participant Flow|Study Sample|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases."
11371803|NCT04017754|FG001|Participant Flow|Control Group 1|The MBL control group comprised 185 Danish female blood donors of reproductive age (range 21 to 45 years), about whom we have no other information than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
10962819|NCT00868608|FG001|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
10962820|NCT00868608|FG002|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11371804|NCT04017754|OG000|Outcome|Study Sample|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and additionally a parental chromosomal analysis in most cases."
11371805|NCT04017754|OG001|Outcome|MBL Reference Group|The MBL reference group comprised 185 Danish female blood donors of reproductive age (range 21 to 45 years), about whom we have no other information than their plasma MBL level. After informed approval, all controls had an extra blood sample taken, which was analysed for MBL.
11371806|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL, but birth weight was missing in 3 patients."
11371807|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL, but birth weight was missing in 2 patients."
11371808|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL, but information on three of these births were excluded from this analysis since they were stillbirths."
11371809|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but 1 was excluded from this analysis since it was a stillbirth."
11376334|NCT00602459|OG000|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
11371810|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL but birth weight was missing in 3 of these patients"
11371811|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL, but birth weight was missing for 2 of these patients."
11240389|NCT02478489|OG000|Outcome|Extended-release Injectable Naltrexone (XR-NTX)|"Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.~Extended-release injectable naltrexone (XR-NTX): injectable naltrexone"
11240390|NCT02478489|OG001|Outcome|Oral Naltrexone (PO-NTX)|"Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.~Oral naltrexone (PO-NTX): oral naltrexone"
11371812|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL but information on three of these births were excluded from this analysis since they were stillbirths."
11371813|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but information on one of these births were excluded from this analysis since it was a stillbirth."
11371814|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL."
11240391|NCT02478489|EG000|Reported Event|Extended-release Injectable Naltrexone (XR-NTX)|"Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.~Extended-release injectable naltrexone (XR-NTX): injectable naltrexone"
11191772|NCT02133742|FG000|Participant Flow|Axitinib 5 mg + Pembrolizumab (MK-3475) 2 mg|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days). Participants received axitinib up to a maximum of 64 cycles and pembrolizumab up to 56 cycles in dose expansion phase (each cycle of 21 days) until documented disease progression or unacceptable toxicity or study discontinuation criteria were met.
11240392|NCT02478489|EG001|Reported Event|Oral Naltrexone (PO-NTX)|"Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.~Oral naltrexone (PO-NTX): oral naltrexone"
11240393|NCT02478580|BG000|Baseline|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
11240394|NCT02478580|BG001|Baseline|Control|Placebo in preoperative area
11240395|NCT02478580|BG002|Baseline|Total|Total of all reporting groups
11240396|NCT02478580|FG000|Participant Flow|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
11240397|NCT02478580|FG001|Participant Flow|Control|"Placebo in preoperative area~Patient will receive placebo before the surgery"
11240398|NCT02478580|OG000|Outcome|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
11240399|NCT02478580|OG001|Outcome|Control|Placebo in preoperative area
11240400|NCT02478580|OG000|Outcome|Nuvigil|A single oral dose of Nuvigil at 150mg dose in preoperative area
10849898|NCT00299130|OG000|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11240401|NCT02478580|OG001|Outcome|Placebo|"A single oral placebo will be given in preoperative area~Nuvigil: Patients will receive Nuvigil before the surgery"
11240402|NCT02478580|EG000|Reported Event|Nuvigil|"A single oral dose of Nuvigil 150 mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
11240403|NCT02478580|EG001|Reported Event|Control|"Placebo in preoperative area~Patient will receive placebo before the surgery"
11240404|NCT02478632|BG000|Baseline|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
11240405|NCT02478632|BG001|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
11240406|NCT02478632|BG002|Baseline|Total|Total of all reporting groups
11240407|NCT02478632|FG000|Participant Flow|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
11240408|NCT02478632|FG001|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
11240409|NCT02478632|OG000|Outcome|DTG + RPV|Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
11240410|NCT02478632|OG001|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
11240411|NCT02478632|OG000|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
10962821|NCT00868608|OG000|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11190159|NCT02123966|EG000|Reported Event|Sirolimus|"A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards. Subjects will maintain a diary and record each dose, the length of time rinsing, and any adverse effects (e.g. transient burning).~Sirolimus"
11190160|NCT02124018|BG000|Baseline|Low Risk Group|No NIRFs present - no invasive PVS performed
11190161|NCT02124018|BG001|Baseline|Intermediate Risk Group|At least one NIRF present - noninducible upon PVS
11190162|NCT02124018|BG002|Baseline|High Risk Group|At least one NIRF present AND inducible upon PVS
11190163|NCT02124018|BG003|Baseline|Total|Total of all reporting groups
11190164|NCT02124018|FG000|Participant Flow|Low Risk Group|No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed
11190165|NCT02124018|FG001|Participant Flow|Intermediate Risk Group|At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration >30seconds or causing hemodynamic instability necessitating termination)
11190166|NCT02124018|FG002|Participant Flow|High Risk Group|At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced).
11190167|NCT02124018|OG000|Outcome|Low Risk Group|No NIRFs present - no invasive PVS performed
11190168|NCT02124018|OG001|Outcome|Intermediate Risk Group|At least one NIRF present - noninducible upon PVS
11190169|NCT02124018|OG002|Outcome|High Risk Group|At least one NIRF present AND inducible upon PVS.
11371815|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL."
11371816|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but information on one of these births were excluded from this analysis since was a stillbirth."
11371817|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL but 1 delivery method was missing."
11371818|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL and data on one delivery method is missing."
11371819|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but data on two delivery methods is missing."
11371820|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL but data on one delivery method is missing."
11376335|NCT00602459|OG001|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
11190170|NCT02124018|OG000|Outcome|Low Risk Group|No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed
11371821|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL but data on one delivery method is missing."
11371822|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but data on two delivery methods were missing."
11371823|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL but information on peripartum hemorrhage were missing in 1 case."
11371824|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL but information on peripartum hemorrhage were missing for 9 patients."
11371825|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but information on peripartum hemorrhage were missing for 5 patients."
11371826|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL but data on one hemorrhage was missing."
11376336|NCT00602459|OG002|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
11371827|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL but information on permpartum hemorrhage was missing for 9 patients."
11371828|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but information on permpartum hemorrhage was missing for 5 patients."
11371829|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL but information on gestational age was missing in 1 patient."
11371830|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL but information on gestational age was missing in 1 patient."
11371831|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL, but information on 2 births were missing and 3 stillbirths were excluded."
11371832|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL but information on 2 births were missing and 1 stillbirth was excluded."
11371833|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL but information on gestational age was missing in 2 patients."
11371834|NCT04017754|OG000|Outcome|Study sampleRPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~79 RPL patients with p-MBL <500 ug/l gave birth after RPL. One of these births was a twin birth of same gender, which was counted as 1."
11371835|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~23 RPL patients with p-MBL >3000 ug/l gave birth after RPL. One of these births was a twin birth of same gender, which was counted as 1."
11371836|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth before RPL and none of these were twins. 7 patients had >1 child birth before RPL of mixed gender and therefore excluded from this analysis."
11371837|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth before RPL and 3 patients had >1 child birth before RPL of mixed gender and therefore excluded from this analysis."
11371838|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~67 RPL patients with p-MBL <500 ug/l gave birth after RPL."
11376337|NCT00602459|OG000|Outcome|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
11371839|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~20 RPL patients with p-MBL >3000 ug/l gave birth after RPL."
11371840|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~54 RPL patients with p-MBL <500 ug/l gave birth >22 weeks before RPL."
11371841|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~26 RPL patients with p-MBL >3000 ug/l gave birth >22 weeks before RPL."
11371842|NCT04017754|OG000|Outcome|RPL Patients With pMBL <500 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~119 RPL patients had MBL>500 ug/l."
11371843|NCT04017754|OG001|Outcome|RPL Patients With p-MBL >3000 ug/l|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases.~46 patients had MBL>3000."
11371844|NCT04017754|EG000|Reported Event|Study Sample|"Women with unexplained recurrent pregnancy loss. Only patients with a history of 3 or more consecutive spontaneous pregnancy losses were included. Both biochemical and clinical losses documented in hospital records were accepted. Verified extrauterine pregnancy losses, complete molar pregnancies, and induced abortions of social and genetic reasons were not included in the total number of pregnancy losses. Women are excluded from this study, if they have significant uterine malformations, significant parental chromosomal abnormalities, irregular and/or abnormal length of their menstrual cycle length (<22 and >35 days interval), and/or no MBL measurement.~At the first consultation in The Centre for Recurrent Pregnancy Loss of Western Denmark, all women have a diagnostic work-up, including collection of an obstetric and gynaecologic history, a routine blood analysis, a uterine hydrosonography, hysteroscopy, or hysterosalpingography, and a parental chromosomal analysis in most cases."
11371845|NCT04010370|BG000|Baseline|Healthy Individuals|3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
11371846|NCT04010370|FG000|Participant Flow|Healthy Individuals|3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
11371847|NCT04010370|OG000|Outcome|Healthy Individuals|3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
11371848|NCT04010370|EG000|Reported Event|Healthy Individuals|Subjects of both sexes (men and women), aged 30-60 years under 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
11240412|NCT02478632|EG000|Reported Event|DTG + RPV (Early Switch)|Participants received DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094.
11240413|NCT02478632|EG001|Reported Event|CAR (Early Switch)|Participants continued to receive their CAR (two NRTIs + a third agent). A third agent included either: an INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094.
11240414|NCT02478632|EG002|Reported Event|DTG + RPV (Early + Late Switch)|Participants received DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the Late Switch Phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094.
11240415|NCT02478632|EG003|Reported Event|CAR (Late Switch)|At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG + RPV once daily and were followed until Week 148 in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094.
11240416|NCT02478671|BG000|Baseline|TR Band|MRI based Radial artery measurement
11240417|NCT02478671|FG000|Participant Flow|TR Band|MRI based radial artery measurement
11240418|NCT02478671|OG000|Outcome|TR Band|MRI based Radial artery measurement
11240419|NCT02478671|OG000|Outcome|TR Band|Pulse Oxymetry
11240420|NCT02478671|EG000|Reported Event|TR Band|MRI based radial artery measurement
11240421|NCT02479139|BG000|Baseline|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240422|NCT02479139|BG001|Baseline|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240423|NCT02479139|BG002|Baseline|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240424|NCT02479139|BG003|Baseline|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240425|NCT02479139|BG004|Baseline|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240426|NCT02479139|BG005|Baseline|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240427|NCT02479139|BG006|Baseline|Total|Total of all reporting groups
11240428|NCT02479139|FG000|Participant Flow|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240429|NCT02479139|FG001|Participant Flow|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240430|NCT02479139|FG002|Participant Flow|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240431|NCT02479139|FG003|Participant Flow|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11371849|NCT03997825|BG000|Baseline|BVN Ablation Arm|Randomized and successfully treated with basivertebral nerve ablation
11371850|NCT03997825|FG000|Participant Flow|BVN Ablation Arm|Per protocol successfully treated United States participants randomized to BVN Ablation arm in the original SMART RCT
11371851|NCT03997825|OG000|Outcome|BVN Ablation Arm|Randomized and successfully treated with basivertebral nerve ablation
11371852|NCT03997825|EG000|Reported Event|BVN Ablation Arm|Randomized and successfully treated with basivertebral nerve ablation
11371853|NCT03975790|BG000|Baseline|Methotrexate (MTX) + Tofacitinib: MTX Persistent|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of >60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371854|NCT03975790|BG001|Baseline|Methotrexate (MTX) + Tofacitinib: MTX Discontinued|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371855|NCT03975790|BG002|Baseline|Methotrexate (MTX) + Tofacitinib: MTX Interrupted|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371856|NCT03975790|BG003|Baseline|Total|Total of all reporting groups
11371857|NCT03975790|FG000|Participant Flow|Methotrexate (MTX) + Tofacitinib: MTX Persistent|Rheumatoid arthritis (RA) diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of more than (>)60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371858|NCT03975790|FG001|Participant Flow|Methotrexate (MTX) + Tofacitinib: MTX Discontinued|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371859|NCT03975790|FG002|Participant Flow|Methotrexate (MTX) + Tofacitinib: MTX Interrupted|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371860|NCT03975790|OG000|Outcome|Methotrexate (MTX) + Tofacitinib: MTX Persistent|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of >60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371861|NCT03975790|OG001|Outcome|Methotrexate (MTX) + Tofacitinib: MTX Discontinued|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371862|NCT03975790|OG002|Outcome|Methotrexate (MTX) + Tofacitinib: MTX Interrupted|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371863|NCT03975790|EG000|Reported Event|Methotrexate (MTX) + Tofacitinib: MTX Persistent|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of >60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371864|NCT03975790|EG001|Reported Event|Methotrexate (MTX) + Tofacitinib: MTX Discontinued|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371865|NCT03975790|EG002|Reported Event|Methotrexate (MTX) + Tofacitinib: MTX Interrupted|RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of >60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
11371866|NCT03979079|BG000|Baseline|Eligible Patients|Eligible Prostate Cancer Patients Undergoing EBRT Treatment
11371867|NCT03979079|FG000|Participant Flow|Patients|Eligible Prostate Cancer Patients Undergoing EBRT Treatment
11371868|NCT03979079|OG000|Outcome|Patients|All patients
11371869|NCT03979079|OG000|Outcome|Patients|Eligible patients
11371870|NCT03979079|EG000|Reported Event|All Patients|Eligible patients
11371871|NCT03895632|BG000|Baseline|Observation|Participants who were recruited and had their data recorded for this observational study.
11371872|NCT03895632|FG000|Participant Flow|Observation|"Patients with strabismus being treated with injections of Botulinum toxin (BTX).~BTX dosage varied from 0.5 to 6.0 Units given in a single injection of fluid."
11371873|NCT03895632|OG000|Outcome|Observation|Participants who were recruited and had their data recorded for this observational study.
11371874|NCT03895632|EG000|Reported Event|Observation|Participants who were recruited and had their data recorded for this observational study.
11371875|NCT03859622|BG000|Baseline|Observational Cohort Cross-sectional Study|The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed. All participants gave written consent.
11371876|NCT03859622|FG000|Participant Flow|Observational Cohort Cross-sectional Study|The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed.
11371877|NCT03859622|OG000|Outcome|Frequencies of Metabolizer Status (PM, IM, NM, UM)|In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
11371878|NCT03859622|OG000|Outcome|Observational Cohort Cross-sectional Study|The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed.
11371879|NCT03859622|OG000|Outcome|Patients With Relevant Knowledge of Metabolizer Status|In 287 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, it was analyzed, if physician's knowledge of his or her metabolizer status would have been of relevance before prescribing the drug.
11371880|NCT03859622|OG000|Outcome|Specific Number of Patients Prescribed a CYP2D6 Relevant Drug|This secondary outcome measure serves to find out how many patients of the whole practice population got at least one prescription of an CYP2D6 metabolized drug (or an inhibitor of CYP2D6) within the last 3 years. The data were extracted from the electronic health records of the practice office. These data have only importance for pharmaco-epidemiological considerations.
11371881|NCT03859622|EG000|Reported Event|Observational Cohort Cross-sectional Study|The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 297 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed.
11371882|NCT03764813|BG000|Baseline|Non-Transfused|13 patients not receiving transfusions.
11371883|NCT03764813|BG001|Baseline|Only Cord-RBC|3 patients receiving exclusively cord-RBC transfusions
11371884|NCT03764813|BG002|Baseline|Only Adult-RBC|4 patients receiving exclusively adult-RBC transfusions
11371885|NCT03764813|BG003|Baseline|Cord- and Adult-RBC|5 patients receiving both adult-RBC and cord-RBC transfusions
11371886|NCT03764813|BG004|Baseline|Total|Total of all reporting groups
11371887|NCT03764813|FG000|Participant Flow|Non Transfused|Patient not receiving transfusions
11190171|NCT02124018|OG001|Outcome|Intermediate Risk Group|At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration >30seconds or causing hemodynamic instability necessitating termination)
11190172|NCT02124018|OG002|Outcome|High Risk Group|At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced).
11190173|NCT02124018|EG000|Reported Event|Low Risk Group|No NIRFs present - no invasive PVS performed
11190174|NCT02124018|EG001|Reported Event|Intermediate Risk Group|At least one NIRF present - noninducible upon PVS
11190175|NCT02124018|EG002|Reported Event|High Risk Group|At least one NIRF present AND inducible upon PVS.
11190176|NCT02124044|BG000|Baseline|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
11190177|NCT02124044|BG001|Baseline|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
11190178|NCT02124044|BG002|Baseline|Total|Total of all reporting groups
11190179|NCT02124044|FG000|Participant Flow|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
11190180|NCT02124044|FG001|Participant Flow|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
11190181|NCT02124044|OG000|Outcome|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
11190182|NCT02124044|OG001|Outcome|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
11190183|NCT02124044|EG000|Reported Event|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
11190184|NCT02124044|EG001|Reported Event|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
11190185|NCT02124083|BG000|Baseline|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
11190186|NCT02124083|FG000|Participant Flow|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
11190187|NCT02124083|OG000|Outcome|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
11190188|NCT02124083|EG000|Reported Event|Vorinostat|Trial participants were treated with Vorinostat (3 days on/4 days off regimen) to limit toxicity. Subjects were initially dosed with 200 mg (two 100 mg capsules) by mouth daily for three months, followed by dose escalation to 400 mg (four 100 mg capsules) by mouth daily for three months.
11190189|NCT02124122|BG000|Baseline|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
11190190|NCT02124122|BG001|Baseline|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
11190191|NCT02124122|BG002|Baseline|Total|Total of all reporting groups
11190192|NCT02124122|FG000|Participant Flow|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
11190193|NCT02124122|FG001|Participant Flow|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
11190194|NCT02124122|OG000|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
11371888|NCT03764813|FG001|Participant Flow|Cord-RBC Transfusions|Patients receiving exclusively allogeneic top up transfusions obtained from healthy full term neonates.
11371889|NCT03764813|FG002|Participant Flow|Adult-RBC Transfusion|Patients receiving exclusively standard RBC transfusions from adult donors
11371890|NCT03764813|FG003|Participant Flow|Cord- and Adult-RBC Transfusions|Patients receiving both types of transfusions
11371891|NCT03764813|OG000|Outcome|Non-transfused|127 HbF measures obtained from 13 preterm neonates surviving until the completion of postmenstrual age of 32 weeks without receiving transfusions
11371892|NCT03764813|OG001|Outcome|Only Cord-RBC|19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions
11371893|NCT03764813|OG002|Outcome|Only adult_RBC|33 HbF measures obtained from 3 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only adult-RBC transfusions
11371894|NCT03764813|OG003|Outcome|Both Cord-RBC and adult_RBC|85 HbF measures obtained from 5 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving both cord-RBC and adult-RBC transfusions
11371895|NCT03764813|OG000|Outcome|Cord-RBC Transfusions|top up transfusions obtained from cord blood of healthy full term neonates.
11371896|NCT03764813|OG001|Outcome|Adult-RBC Transfusions|top up transfusions obtained from adult blood donors
11371897|NCT03764813|OG000|Outcome|Non Transfused|Patient not receiving transfusions
11371898|NCT03764813|OG001|Outcome|Cord-RBC Transfusions|Patients receiving exclusively allogeneic top up transfusions obtained from healthy full term neonates.
11371899|NCT03764813|OG002|Outcome|Adult-RBC Transfusion|Patients receiving exclusively standard RBC transfusions from adult donors
11371900|NCT03764813|OG003|Outcome|Cord- and Adult-RBC Transfusions|Patients receiving both types of transfusions
11371901|NCT03764813|EG000|Reported Event|Non-transfused|13 preterm neonates non receiving transfusions
11371902|NCT03764813|EG001|Reported Event|Only Cord-TBC|3 neonates receiving only cord-RBC
11371903|NCT03764813|EG002|Reported Event|Only Adult-RBC|4 neonates receiving only adult-RBC
11371904|NCT03764813|EG003|Reported Event|Both Cord- and Adult-RBC|5 neonates receiving both RBC types
11376338|NCT00602459|OG001|Outcome|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
11376339|NCT00602459|OG002|Outcome|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
11376340|NCT00602459|OG000|Outcome|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
11376341|NCT00602459|OG001|Outcome|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
11376342|NCT00602459|OG000|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
11376343|NCT00602459|OG001|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
11376344|NCT00602459|EG000|Reported Event|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
11376345|NCT00602459|EG001|Reported Event|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
11371905|NCT04941521|BG000|Baseline|Exenatide and Drug Counseling|"Participants will receive once weekly exenatide injections and drug counseling sessions.~Exenatide 2 mg [Bydureon]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.~Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists."
11371906|NCT04941521|FG000|Participant Flow|Exenatide and Drug Counseling|"Participants will receive once weekly exenatide injections and drug counseling sessions.~Exenatide 2 mg [Bydureon]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.~Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists."
11371907|NCT04941521|OG000|Outcome|Exenatide and Drug Counseling|"Participants will receive once weekly exenatide injections and drug counseling sessions.~Exenatide 2 mg [Bydureon]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.~Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists."
11371908|NCT04941521|EG000|Reported Event|Exenatide and Drug Counseling|"Participants will receive once weekly exenatide injections and drug counseling sessions.~Exenatide 2 mg [Bydureon]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.~Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists."
11371909|NCT04584788|BG000|Baseline|Healthy Adult Volunteers|"Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.~Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors."
11371910|NCT04584788|FG000|Participant Flow|Healthy Adult Volunteers|"Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.~Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors."
11371911|NCT04584788|OG000|Outcome|Healthy Adult Volunteers|"Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.~Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors."
11371912|NCT04584788|EG000|Reported Event|Healthy Adult Volunteers|"Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.~Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors."
11371913|NCT04219618|BG000|Baseline|On-Pump|On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
11371914|NCT04219618|BG001|Baseline|Off-Pump|Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
11371915|NCT04219618|BG002|Baseline|Total|Total of all reporting groups
11371916|NCT04219618|FG000|Participant Flow|On-Pump|On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
11376346|NCT00602459|EG002|Reported Event|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
11190195|NCT02124122|OG001|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
11371917|NCT04219618|FG001|Participant Flow|Off-Pump|Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
11371918|NCT04219618|OG000|Outcome|On-Pump|On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
11371919|NCT04219618|OG001|Outcome|Off-Pump|Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
11371920|NCT04219618|EG000|Reported Event|Off-Pump|Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
11371921|NCT04219618|EG001|Reported Event|On-Pump|On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
11371922|NCT03783923|BG000|Baseline|Deflazacort|Participants received deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day.
11371923|NCT03783923|BG001|Baseline|Placebo|Participants received placebo matched to deflazacort tablets, administered orally once daily for 26 weeks in placebo-controlled period. Participants were then transitioned to receive deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day for 26 weeks in open-label extension period.
11371924|NCT03783923|BG002|Baseline|Total|Total of all reporting groups
11371925|NCT03783923|FG000|Participant Flow|Deflazacort|Participants received deflazacort tablets, administered orally once daily at a target dose of 0.6 milligrams (mg)/kilograms (kg)/day for 26 weeks in placebo-controlled period and for 26 weeks in open-label extension period.
11371926|NCT03783923|FG001|Participant Flow|Placebo|Participants received placebo matched to deflazacort tablets, administered orally once daily for 26 weeks in placebo-controlled period. Participants were then transitioned to receive deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day for 26 weeks in open-label extension period.
11371927|NCT03783923|OG000|Outcome|Deflazacort|Participants received deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day.
11371928|NCT03783923|EG000|Reported Event|Deflazacort|Participants received deflazacort tablets, administered orally once daily at a target dose of 0.6 mg/kg/day.
11190196|NCT02124122|EG000|Reported Event|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
11190197|NCT02124122|EG001|Reported Event|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
11190198|NCT02124161|BG000|Baseline|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190199|NCT02124161|BG001|Baseline|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190200|NCT02124161|BG002|Baseline|Total|Total of all reporting groups
11190201|NCT02124161|FG000|Participant Flow|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190202|NCT02124161|FG001|Participant Flow|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190203|NCT02124161|OG000|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190204|NCT02124161|OG001|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190205|NCT02124161|OG000|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
11190206|NCT02124161|EG000|Reported Event|13vPnC+QIV/Placebo: After Vaccination 1|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
11190207|NCT02124161|EG001|Reported Event|Placebo+QIV/13vPnC: After Vaccination 1|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
11190208|NCT02124161|EG002|Reported Event|13vPnC+QIV/Placebo: After Vaccination 2|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
11190209|NCT02124161|EG003|Reported Event|Placebo+QIV/13vPnC: After Vaccination 2|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
11190210|NCT02124161|EG004|Reported Event|13vPnC+QIV/Placebo: After 13vPnC Vaccination|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
11190211|NCT02124161|EG005|Reported Event|Placebo+QIV/13vPnC: After 13vPnC Vaccination|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
11190212|NCT02124161|EG006|Reported Event|13vPnC+QIV/Placebo: at 6-Month Follow-up|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
11190213|NCT02124161|EG007|Reported Event|Placebo+QIV/13vPnC: at 6-Month Follow-up|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
11190214|NCT02124265|BG000|Baseline|Oral Rehydration Therapy|Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
11190215|NCT02124265|FG000|Participant Flow|Oral Rehydration Therapy|Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, nasogastric, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
11190216|NCT02124265|OG000|Outcome|Oral Rehydration Therapy|Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
11190217|NCT02124265|EG000|Reported Event|Oral Rehydration Therapy|Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
11190218|NCT02124304|BG000|Baseline|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190219|NCT02124304|BG001|Baseline|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190220|NCT02124304|BG002|Baseline|Total|Total of all reporting groups
11190221|NCT02124304|FG000|Participant Flow|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190222|NCT02124304|FG001|Participant Flow|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190223|NCT02124304|OG000|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190224|NCT02124304|OG001|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190225|NCT02124304|EG000|Reported Event|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190226|NCT02124304|EG001|Reported Event|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
11190227|NCT02124460|BG000|Baseline|Enhanced Primary Care|"Arm: No Intervention: Enhanced Primary Care We will provide current best practice to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
11190228|NCT02124460|BG001|Baseline|Health Coaching|Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
11190229|NCT02124460|BG002|Baseline|Total|Total of all reporting groups
11190230|NCT02124460|FG000|Participant Flow|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
11371929|NCT03718429|BG000|Baseline|Aspirin|The cohort of patients on aspirin was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11190231|NCT02124460|FG001|Participant Flow|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
11190232|NCT02124460|OG000|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
11190233|NCT02124460|OG001|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
11190234|NCT02124460|OG000|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
11190235|NCT02124460|EG000|Reported Event|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
11190236|NCT02124460|EG001|Reported Event|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
11190237|NCT02124512|BG000|Baseline|Arm 1 Rifaximin SSD|"Subjects randomized to this arm of the study will receive 80 mg per day Rifaximin SSD~Rifaximin SSD: Study Drug dosing will be 80 mg SSD once daily"
11190238|NCT02124512|BG001|Baseline|Arm 2 Placebo|"Placebo~Placebo: 80 mg placebo once daily"
11190239|NCT02124512|BG002|Baseline|Total|Total of all reporting groups
11190240|NCT02124512|FG000|Participant Flow|Arm 1 Rifaximin SSD|"Subjects randomized to this arm of the study will receive 80 mg per day Rifaximin SSD~Rifaximin SSD: Study Drug dosing will be 80 mg SSD once daily"
11190241|NCT02124512|FG001|Participant Flow|Arm 2 Placebo|"Placebo~Placebo: 80 mg placebo once daily"
11190242|NCT02124512|OG000|Outcome|Arm 1 Rifaximin SSD|"Subjects randomized to this arm of the study will receive 80 mg per day Rifaximin SSD~Rifaximin SSD: Study Drug dosing will be 80 mg SSD once daily"
11190243|NCT02124512|OG001|Outcome|Arm 2 Placebo|"Placebo~Placebo: 80 mg placebo once daily"
11190244|NCT02124512|EG000|Reported Event|Arm 1 Rifaximin SSD|"Subjects randomized to this arm of the study will receive 80 mg per day Rifaximin SSD~Rifaximin SSD: Study Drug dosing will be 80 mg SSD once daily"
11190245|NCT02124512|EG001|Reported Event|Arm 2 Placebo|"Placebo~Placebo: 80 mg placebo once daily"
11190246|NCT02124564|BG000|Baseline|Lacosamide|Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
11190247|NCT02124564|FG000|Participant Flow|Lacosamide|Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
11190248|NCT02124564|OG000|Outcome|Lacosamide (Safety Set)|Subjects randomized in this arm received lacosamide from 200 mg/day to 600 g/day, from the Titration to the End of Study Visit (up to 3.5 years).
11190249|NCT02124564|OG000|Outcome|Lacosamide (FAS)|Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
11190250|NCT02124564|EG000|Reported Event|Lacosamide|Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
11190251|NCT02124603|BG000|Baseline|Single Group|Consecutive patients scheduled for cataract surgery
11190252|NCT02124603|FG000|Participant Flow|Single Group|Patients undergone cataract surgery
11190253|NCT02124603|OG000|Outcome|Single Group|Patients undergone cataract surgery
11190254|NCT02124603|OG000|Outcome|Single Group|patients undergone cataract surgery
11190255|NCT02124603|EG000|Reported Event|Single Group|Patients to have to undergone cataract surgery
11191773|NCT02133742|OG000|Outcome|Axitinib 5 mg + Pembrolizumab 2 mg: Dose Finding Phase|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days).
11190256|NCT02124707|BG000|Baseline|Carboplatin, Paclitaxel and Cetuximab|"A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.~Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue at the 250mg/m2 dose until disease progression.~Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.~Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week"
11240432|NCT02479139|FG004|Participant Flow|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11371930|NCT03718429|BG001|Baseline|Aspirin Plus Clopidogrel|The cohort of patients on aspirin plus clopidogrel was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371931|NCT03718429|BG002|Baseline|Aspirin Plus Ticagrelor|The cohort of patients on aspirin plus ticagrelor was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371932|NCT03718429|BG003|Baseline|Rivaroxaban 20 mg|The cohort of patients on rivaroxaban remained on rivaroxaban 20 mg daily.
11371933|NCT03718429|BG004|Baseline|Total|Total of all reporting groups
11371934|NCT03718429|FG000|Participant Flow|Aspirin|The cohort of patients on aspirin (81 mg daily) was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371935|NCT03718429|FG001|Participant Flow|Aspirin Plus Clopidogrel|The cohort of patients on aspirin (81 mg daily) plus clopidogrel (75 mg dailiy) was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371936|NCT03718429|FG002|Participant Flow|Aspirin Plus Ticagrelor|The cohort of patients on aspirin (81 mg daily) plus ticagrelor (90 mg bid) was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371937|NCT03718429|FG003|Participant Flow|Rivaroxaban 20 mg|The cohort of patients on rivaroxaban remained on rivaroxaban 20 mg daily.
11371938|NCT03718429|OG000|Outcome|Aspirin Plus Clopidogrel|Cohort of patients on aspirin plus clopidogrel
11371939|NCT03718429|OG001|Outcome|Aspirin Plus Clopidogrel Plus Rivaroxaban|Cohort of patients on aspirin, clopidogrel and rivaroxaban
11371940|NCT03718429|OG002|Outcome|Clopidogrel Plus Rivaroxaban|Cohort of patients on clopidogrel plus rivaroxaban
11371941|NCT03718429|OG003|Outcome|Aspirin|Cohort of patients on aspirin only
11371942|NCT03718429|OG004|Outcome|Aspirin Plus Rivaroxaban|Cohort of patients on aspirin plus rivaroxaban
11371943|NCT03718429|OG005|Outcome|Rivaroxaban|Cohort of patients on rivaroxaban alone
11371944|NCT03718429|OG006|Outcome|Aspirin Plus Ticagrelor|Cohort of patients on aspirin plus ticagrelor
11371945|NCT03718429|OG007|Outcome|Aspirin Plus Ticagrelor Plus Rivaroxaban|Cohort of patients on aspirin plus ticagrelor plus rivaroxaban
11371946|NCT03718429|OG008|Outcome|Ticagrelor Plus Rivaroxaban|Cohort of patients on ticagrelor plus rivaroxaban
11371947|NCT03718429|OG009|Outcome|Rivaroxaban 20 mg|Cohort of patients on rivaroxaban 20 mg
11371948|NCT03718429|OG002|Outcome|Clopidogrel Plus Rivaroxaban|Cohort of patients on clopidogrel and rivaroxaban
11371949|NCT03718429|OG004|Outcome|Aspirin Plus Rivaroxaban|Cohort of patients on aspirin and rivaroxaban
11371950|NCT03718429|OG009|Outcome|Rivaroxaban 20 mg|Cohort of patients on rivaroxaban 20 mg only
11371951|NCT03718429|OG005|Outcome|Rivaroxaban|Cohort of patients on rivaroxaban 2.5 mg only
11371952|NCT03718429|EG000|Reported Event|Aspirin|The cohort of patients on aspirin was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371953|NCT03718429|EG001|Reported Event|Aspirin Plus Clopidogrel|The cohort of patients on aspirin plus clopidogrel was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371954|NCT03718429|EG002|Reported Event|Aspirin Plus Ticagrelor|The cohort of patients on aspirin plus ticagrelor was treated with adjunctive vascular dose rivaroxaban (2.5 mg/bid) for 7-10 days, after which aspirin therapy was suspended for 7-10 days.
11371955|NCT03718429|EG003|Reported Event|Rivaroxaban|The cohort of patients on rivaroxaban remained on rivaroxaban 20 mg daily.
11371956|NCT03315130|BG000|Baseline|RA101495 0.1 mg/kg|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
11371957|NCT03315130|BG001|Baseline|RA101495 0.3 mg/kg|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
11240433|NCT02479139|FG005|Participant Flow|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240434|NCT02479139|OG000|Outcome|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240435|NCT02479139|OG001|Outcome|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240436|NCT02479139|OG002|Outcome|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240437|NCT02479139|OG003|Outcome|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240438|NCT02479139|OG004|Outcome|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240439|NCT02479139|OG005|Outcome|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240440|NCT02479139|EG000|Reported Event|Vehicle|Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240441|NCT02479139|EG001|Reported Event|ANT-1207 Dose 1|Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240442|NCT02479139|EG002|Reported Event|ANT-1207 Dose 2|Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240443|NCT02479139|EG003|Reported Event|ANT-1207 Dose 3|Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240444|NCT02479139|EG004|Reported Event|ANT-1207 Dose 4|Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240445|NCT02479139|EG005|Reported Event|ANT-1207 Dose 5|Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
11240446|NCT02479412|BG000|Baseline|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240447|NCT02479412|BG001|Baseline|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240448|NCT02479412|BG002|Baseline|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240449|NCT02479412|BG003|Baseline|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240450|NCT02479412|BG004|Baseline|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240451|NCT02479412|BG005|Baseline|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240452|NCT02479412|BG006|Baseline|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240453|NCT02479412|BG007|Baseline|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240454|NCT02479412|BG008|Baseline|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240455|NCT02479412|BG009|Baseline|Total|Total of all reporting groups
11240456|NCT02479412|FG000|Participant Flow|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11371958|NCT03315130|BG002|Baseline|Placebo|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
11371959|NCT03315130|BG003|Baseline|Total|Total of all reporting groups
11371960|NCT03315130|FG000|Participant Flow|RA101495 0.1 mg/kg|Participants received RA101495 0.1 milligram/kilogram (mg/kg) as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension portion, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion (EP).
11371961|NCT03315130|FG001|Participant Flow|RA101495 0.3 mg/kg|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
11371962|NCT03315130|FG002|Participant Flow|Placebo|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
11371963|NCT03315130|FG003|Participant Flow|RA101495 0.1 mg/kg (Before Switch) to 0.3 mg/kg (After Switch)|Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
11371964|NCT03315130|OG000|Outcome|RA101495 0.1 mg/kg (mITT)|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
11371965|NCT03315130|OG001|Outcome|RA101495 0.3 mg/kg (mITT)|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
11371966|NCT03315130|OG002|Outcome|Placebo (mITT)|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
11371967|NCT03315130|OG000|Outcome|RA101495 0.1 mg/kg (SS)|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the safety set (SS) population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
11371968|NCT03315130|OG001|Outcome|RA101495 0.3 mg/kg (SS)|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the SS population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
11371969|NCT03315130|OG002|Outcome|Placebo (SS)|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the SS population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
11371970|NCT03315130|OG000|Outcome|RA101495 0.1 mg/kg (PD)|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
11371971|NCT03315130|OG001|Outcome|RA101495 0.3 mg/kg (PD)|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
11371972|NCT03315130|OG002|Outcome|Placebo (PD)|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
11371973|NCT03315130|OG001|Outcome|RA101495 0.3 mg/kg (PD)|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
11190257|NCT02124707|FG000|Participant Flow|Carboplatin, Paclitaxel and Cetuximab|"A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.~Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue at the 250mg/m2 dose until disease progression.~Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.~Carboplatin: Squared Area under the curve (AUC2), IV (in the vein) on day 1 of each 1 week for 6 week"
11190258|NCT02124707|OG000|Outcome|Carboplatin, Paclitaxel and Cetuximab|"A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.~Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.~Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.~Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week"
11190259|NCT02124707|OG000|Outcome|Carboplatin, Paclitaxel and Cetuximab|"A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.~Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.~Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.~Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks."
11190260|NCT02124707|EG000|Reported Event|Carboplatin, Paclitaxel and Cetuximab|"A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.~Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.~Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.~Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks."
11371974|NCT03315130|OG000|Outcome|RA101495 0.1 mg/kg (PK)|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
11371975|NCT03315130|OG001|Outcome|RA101495 0.3 mg/kg (PK)|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
11190261|NCT02124746|BG000|Baseline|Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.
11371976|NCT03315130|EG000|Reported Event|Main Portion: RA101495 0.1 mg/kg|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion.
11371977|NCT03315130|EG001|Reported Event|Main Portion: RA101495 0.3 mg/kg|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion
11371978|NCT03315130|EG002|Reported Event|Main Portion: Placebo|Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion.
11371979|NCT03315130|EG003|Reported Event|Main and Extension Portion: RA101495 0.1 mg/kg Before Switch to 0.3 mg/kg|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
11371980|NCT03315130|EG004|Reported Event|Main and Extension Portion: RA101495 0.1 mg/kg After Switch to 0.3 mg/kg|Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to Week 48 (until protocol amendment v3.0). Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
11190262|NCT02124746|BG001|Baseline|Cohort 2 (YM387-II-02/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.
11371981|NCT03315130|EG005|Reported Event|Main and Extension Portion: RA101495 0.3 mg/kg|Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
11371982|NCT03206476|BG000|Baseline|Intervention Group|"Nutritional intervention based on the SCT and the TM~Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents."
11371983|NCT03206476|BG001|Baseline|Control Group|"Nutritional information~Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents."
11371984|NCT03206476|BG002|Baseline|Total|Total of all reporting groups
11371985|NCT03206476|FG000|Participant Flow|Intervention Group|"Nutritional intervention based on the SCT and the TM~Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents."
11371986|NCT03206476|FG001|Participant Flow|Control Group|"Nutritional information~Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents."
11371987|NCT03206476|OG000|Outcome|Intervention Group|"Nutritional intervention based on the SCT and the TM~Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents."
11371988|NCT03206476|OG001|Outcome|Control Group|"Nutritional information~Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents."
11371989|NCT03206476|EG000|Reported Event|Intervention Group|"Nutritional intervention based on the SCT and the TM~Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents."
11371990|NCT03206476|EG001|Reported Event|Control Group|"Nutritional information~Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents."
11371991|NCT03057106|BG000|Baseline|Durvalumab and Tremelimumab|"Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab"
11371992|NCT03057106|BG001|Baseline|Platinum Based Chemotherapy + Durvalumab + Tremelimumab|"4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)~Followed by:~Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab~Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine"
11371993|NCT03057106|BG002|Baseline|Total|Total of all reporting groups
11371994|NCT03057106|FG000|Participant Flow|Durvalumab and Tremelimumab|"Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab"
11371995|NCT03057106|FG001|Participant Flow|Platinum Based Chemotherapy + Durvalumab + Tremelimumab|"4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)~Followed by:~Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab~Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine"
11371996|NCT03057106|OG000|Outcome|Durvalumab and Tremelimumab|"Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab"
11371997|NCT03057106|OG001|Outcome|Platinum Based Chemotherapy + Durvalumab + Tremelimumab|"4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)~Followed by:~Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab~Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine"
11371998|NCT03057106|EG000|Reported Event|Durvalumab and Tremelimumab|"Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab"
11371999|NCT03057106|EG001|Reported Event|Platinum Based Chemotherapy + Durvalumab + Tremelimumab|"4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)~Followed by:~Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD~Durvalumab: MEDI4736~Tremelimumab: Tremelimumab~Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine"
11372000|NCT03022461|BG000|Baseline|Ongoing HM3 CE Mark Study Patients|Patients who were ongoing after two years follow-up in the HeartMate 3 CE Mark study (NCT02170363) and consented to participate in long-term follow-up data collection.
11372001|NCT03022461|FG000|Participant Flow|Ongoing HM3 CE Mark Study Patients|Patients who were ongoing after two years follow-up in the HeartMate 3 CE Mark study (NCT02170363) and consented to participate in long-term follow-up data collection.
11372002|NCT03022461|OG000|Outcome|Ongoing HM3 CE Mark Study Patients|Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
11372003|NCT03022461|OG000|Outcome|Ongoing HM3 CE Mark Study Patients|Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
11372004|NCT03022461|EG000|Reported Event|Ongoing HM3 CE Mark Study Patients|Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
11240457|NCT02479412|FG001|Participant Flow|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11372005|NCT02927262|BG000|Baseline|Gilteritinib|Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372006|NCT02927262|BG001|Baseline|Placebo|Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372007|NCT02927262|BG002|Baseline|Total|Total of all reporting groups
11372008|NCT02927262|FG000|Participant Flow|Gilteritinib|Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372009|NCT02927262|FG001|Participant Flow|Placebo|Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372010|NCT02927262|OG000|Outcome|Gilteritinib|Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372011|NCT02927262|OG001|Outcome|Placebo|Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372012|NCT02927262|EG000|Reported Event|Gilteritinib|Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372013|NCT02927262|EG001|Reported Event|Placebo|Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
11372014|NCT02892955|BG000|Baseline|HeartMate 3 LVAS (HM3 LVAS)|"The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.~HeartMate 3 LVAS: Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study."
11372015|NCT02892955|FG000|Participant Flow|HeartMate 3 LVAS (HM3 LVAS)|"The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.~HeartMate 3 LVAS: Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study."
11372016|NCT02892955|OG000|Outcome|HeartMate 3 LVAS (HM3 LVAS)|Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
11372017|NCT02892955|EG000|Reported Event|HeartMate 3 LVAS (HM3 LVAS)|Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
11372018|NCT02689349|BG000|Baseline|Esteem Implant Prospective Subjects|Subjects meeting indications for candidacy are followed through 1 year for both Safety and Efficacy endpoints
11372019|NCT02689349|BG001|Baseline|Esteem Implant Retrospective Chart Review Subjects|Subjects meeting indications for candidacy for Safety endpoints provide Safety-only data via retrospective chart review, which will supplement the Prospective Subjects' Safety data in order to reach required N.
11372020|NCT02689349|BG002|Baseline|Total|Total of all reporting groups
11372021|NCT02689349|FG000|Participant Flow|Esteem Implant Prospective Subjects|Implantation of Esteem: Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints.
11372022|NCT02689349|FG001|Participant Flow|Esteem Implant Retrospective Chart Review Subjects|Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
11372023|NCT02689349|OG000|Outcome|Esteem Implant Prospective Subjects|Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.
11372024|NCT02689349|OG000|Outcome|Esteem Implant Prospective Subjects|Subjects meeting indications for candidacy are followed through 1 year for both Safety and Efficacy endpoints
11372025|NCT02689349|OG000|Outcome|Esteem Implant Prospective Subjects|Implantation of Esteem: Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints.
11372026|NCT02689349|OG001|Outcome|Esteem Implant Retrospective Chart Review Subjects|Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
11372027|NCT02689349|OG001|Outcome|Esteem Implant Retrospective Chart Review Subjects|Subjects meeting indications for candidacy for Safety endpoints provide Safety-only data via retrospective chart review, which will supplement the Prospective Subjects' Safety data in order to reach required N.
11372028|NCT02689349|EG000|Reported Event|Esteem Implant Prospective Subjects|Subjects meeting indications who were implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints.
11372029|NCT02689349|EG001|Reported Event|Esteem Implant Retrospective Chart Review Subjects|Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
11372030|NCT02680574|BG000|Baseline|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372031|NCT02680574|BG001|Baseline|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11372032|NCT02680574|BG002|Baseline|Total|Total of all reporting groups
11190263|NCT02124746|BG002|Baseline|Cohort 4 (GS-US-352-1672/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.
11190264|NCT02124746|BG003|Baseline|Total|Total of all reporting groups
11190265|NCT02124746|FG000|Participant Flow|Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.
11190266|NCT02124746|FG001|Participant Flow|Cohort 2 (YM387-II-02/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.
11190267|NCT02124746|FG002|Participant Flow|Cohort 4 (GS-US-352-1672/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.
11190268|NCT02124746|OG000|Outcome|Total|All subjects enrolled to Study GS-US-352-1154
11190269|NCT02124746|OG000|Outcome|Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.
11190270|NCT02124746|OG001|Outcome|Cohort 2 (YM387-II-02/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.
11190271|NCT02124746|OG002|Outcome|Cohort 4 (GS-US-352-1672/GS-US-352-1154)|Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.
11190272|NCT02124746|OG003|Outcome|Total|All subjects enrolled to Study GS-US-352-1154
11190273|NCT02124746|EG000|Reported Event|Total|All subjects enrolled to Study GS-US-352-1154
11190274|NCT02124759|BG000|Baseline|Placebo|placebo, maltodextrin, 6 g three times a day
11190275|NCT02124759|BG001|Baseline|Sevelamer|Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day
11190276|NCT02124759|BG002|Baseline|Synbiotic|*synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion CFU/g)three times a day]
11190277|NCT02124759|BG003|Baseline|Total|Total of all reporting groups
11190278|NCT02124759|FG000|Participant Flow|Placebo|"placebo, maltodextrin, 6 g three times a day during diet~This is a control group."
11190279|NCT02124759|FG001|Participant Flow|Sevelamer|Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day during diet
11372033|NCT02680574|FG000|Participant Flow|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372034|NCT02680574|FG001|Participant Flow|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11372035|NCT02680574|OG000|Outcome|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372036|NCT02680574|OG001|Outcome|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11372037|NCT02680574|EG000|Reported Event|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372038|NCT02680574|EG001|Reported Event|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11372039|NCT02648347|BG000|Baseline|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372040|NCT02648347|BG001|Baseline|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
11372041|NCT02648347|BG002|Baseline|Total|Total of all reporting groups
11372042|NCT02648347|FG000|Participant Flow|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372043|NCT02648347|FG001|Participant Flow|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
11372044|NCT02648347|OG000|Outcome|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372045|NCT02648347|OG001|Outcome|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
11372046|NCT02648347|EG000|Reported Event|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11372047|NCT02648347|EG001|Reported Event|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
11372048|NCT02396342|BG000|Baseline|AAV5-hFIX Low Dose (Cohort 1)|"AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372049|NCT02396342|BG001|Baseline|AAV5-hFIX High Dose (Cohort 2)|"AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372050|NCT02396342|BG002|Baseline|Total|Total of all reporting groups
11372051|NCT02396342|FG000|Participant Flow|AAV5-hFIX Low Dose (Cohort 1)|"AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372052|NCT02396342|FG001|Participant Flow|AAV5-hFIX High Dose (Cohort 2)|"AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372053|NCT02396342|OG000|Outcome|AAV5-hFIX Low Dose (Cohort 1)|"AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11190280|NCT02124759|FG002|Participant Flow|Synbiotic|5g Oligofructose + 4x1010 Bifidobacterium longum CFU 3x daily during diet
11190281|NCT02124759|OG000|Outcome|Placebo|placebo, maltodextrin, 6 g three times a day
11190282|NCT02124759|OG001|Outcome|Sevelamer|Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day
11190283|NCT02124759|OG002|Outcome|Synbiotic|*synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion CFU/g)three times a day]
11190284|NCT02124759|OG000|Outcome|Placebo|Maltodextrin: This is a control group. Maltodextrin, 6 g three times a day
11372054|NCT02396342|OG001|Outcome|AAV5-hFIX High Dose (Cohort 2)|"AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372055|NCT02396342|EG000|Reported Event|AAV5-hFIX Low Dose (Cohort 1)|"AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372056|NCT02396342|EG001|Reported Event|AAV5-hFIX High Dose (Cohort 2)|"AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion~AAV5-hFIX: AAV5hFIX gene therapy"
11372057|NCT02307253|BG000|Baseline|Patients With Solid Lesions|"all consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study.~Selection criteria All adults (>18 years of age) referred for EUS-FNA of solid lesions adjacent to or located in the wall of the duodenum with no previous tissue diagnosis were considered eligible. In the presence of a cystic component, the solid part of the lesion should have been more than 75% of the total. Patients with uncorrectable coagulopathy as defined by abnormal prothrombin time or partial thromboplastin time that did not normalize after administration of fresh frozen plasma, with altered anatomy of the upper GI tract due to surgery of the esophagus, stomach, and duodenum and those unable to understand and/or read the consent form were excluded from the current study."
11372058|NCT02307253|FG000|Participant Flow|Patients With Solid Lesions|"Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)~Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle"
11372059|NCT02307253|OG000|Outcome|Patients With Solid Lesions|Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
11372060|NCT02307253|EG000|Reported Event|Patients With Solid Lesions|"Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)~Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle"
11372061|NCT02224755|BG000|Baseline|HeartMate II (Intent-to-Treat)|Patients randomized to HeartMate II LVAS (control device)
11372062|NCT02224755|BG001|Baseline|HeartMate 3 (Intent-to-Treat)|Patients randomized to HeartMate 3 LVAS
11372063|NCT02224755|BG002|Baseline|Total|Total of all reporting groups
11372064|NCT02224755|FG000|Participant Flow|HeartMate II (Intent-to-Treat)|Patients randomized to HeartMate II LVAS (control device)
11372065|NCT02224755|FG001|Participant Flow|HeartMate 3 (Intent-to-Treat)|Patients randomized to HeartMate 3 LVAS
11372066|NCT02224755|OG000|Outcome|HeartMate II (Intent-to-Treat)|Patients randomized to HeartMate II LVAS (control device)
11372067|NCT02224755|OG001|Outcome|HeartMate 3 (Intent-to-Treat)|Patients randomized to HeartMate 3 LVAS
11372068|NCT02224755|OG000|Outcome|HeartMate II (As-Treated)|Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
11372069|NCT02224755|OG001|Outcome|HeartMate 3 (As-Treated)|Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
11372070|NCT02224755|OG000|Outcome|HeartMate II (As-Treated)|Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device and were discharged on LVAD support
11372071|NCT02224755|OG001|Outcome|HeartMate 3 (As-Treated)|Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device and were discharged on LVAD support
11372072|NCT02224755|EG000|Reported Event|HeartMate II (As-Treated)|Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
11372073|NCT02224755|EG001|Reported Event|HeartMate 3 (As-Treated)|Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
11372074|NCT02170363|BG000|Baseline|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
11372075|NCT02170363|FG000|Participant Flow|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
11372076|NCT02170363|OG000|Outcome|HeartMate 3|HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
11372077|NCT02170363|OG000|Outcome|HeartMate 3|Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
11372078|NCT02170363|OG000|Outcome|HeartMate 3|"Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure~Left Ventricular Assist System (LVAS): Implantation of left ventricular assist device for hemodynamic support"
11372079|NCT02170363|EG000|Reported Event|HeartMate 3|Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
11376347|NCT00602459|EG003|Reported Event|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
11240458|NCT02479412|FG002|Participant Flow|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11372080|NCT02090114|BG000|Baseline|Cohort A:Post-enzalutamide|"Men with castration-resistant prostate cancer who have progressed on enzalutamide will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with enzalutamide 160 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Enzalutamide: XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides."
11372081|NCT02090114|BG001|Baseline|Cohort B: Post-abiraterone|"Men with castration-resistant prostate cancer who have progressed on abiraterone will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with abiraterone 1000 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Abiraterone acetate: Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate."
11372082|NCT02090114|BG002|Baseline|Cohort C: Castration Only|"Men with metastatic prostate cancer who have only received first line hormone therapy with LHRH agonist alone or LHRH agonist plus an anti-androgen. Patients who have developed castrate resistance to first line therapy and have then received second line hormone therapy of any kind (including flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone, enzalutamide, ARN-509 and investigational anti-androgens) are not eligible for enrollment in this cohort.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11372083|NCT02090114|BG003|Baseline|Cohort D: Mutation|"Men with metastatic prostate cancer who have castrate resistant prostate cancer with inactivating somatic or germline mutations in the genes TP53, RB1 or PTEN identified using clinical grade sequencing of tumor tissue performed by qualified laboratory. Patients must have mutations in ≥2 of these genes to be eligible. Eligible patients must have progressed on first line hormone therapy with LHRH agonist alone and must have received at least one but not more than two second generation androgen ablative therapy (i.e. Abiraterone, Enzalutamide or Apalutamide).~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11372084|NCT02090114|BG004|Baseline|Total|Total of all reporting groups
11376348|NCT00593840|BG000|Baseline|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
11376349|NCT00593840|FG000|Participant Flow|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
11190285|NCT02124759|OG002|Outcome|Synbiotic|Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.
11372085|NCT02090114|FG000|Participant Flow|Cohort A:Post-enzalutamide|"Men with castration-resistant prostate cancer who have progressed on enzalutamide will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with enzalutamide 160 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Enzalutamide: XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides."
11372086|NCT02090114|FG001|Participant Flow|Cohort B: Post-abiraterone|"Men with castration-resistant prostate cancer who have progressed on abiraterone will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with abiraterone 1000 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Abiraterone acetate: Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate."
11372087|NCT02090114|FG002|Participant Flow|Cohort C: Castration Only|"Men with metastatic prostate cancer who have only received first line hormone therapy with LHRH agonist alone or LHRH agonist plus an anti-androgen. Patients who have developed castrate resistance to first line therapy and have then received second line hormone therapy of any kind (including flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone, enzalutamide, ARN-509 and investigational anti-androgens) are not eligible for enrollment in this cohort.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11376350|NCT00593840|OG000|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
11376351|NCT00593840|EG000|Reported Event|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
11376352|NCT00567580|BG000|Baseline|PBRT Alone|Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
11190286|NCT02124759|OG000|Outcome|Placebo|"The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.~subjects will be randomized to receive, in a double-blind fashion~Maltodextrin: This is a control group. Maltodextrin, 6 g three times a day"
11190287|NCT02124759|OG001|Outcome|Sevelamer|"The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.~subjects will be randomized to receive, in a double-blind fashion Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day"
11190288|NCT02124759|OG002|Outcome|Synbiotic|"The high fat diet will provide 60% of energy from fat (of which 50% from saturated fat), 15% of energy as CHO and 25% from protein.~subjects will be randomized to receive, in a double-blind fashion Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day."
11190289|NCT02124759|EG000|Reported Event|Placebo|"Maltodextrin: This is a control group that were fed both low and high fat diets.~Maltodextrin, 6 g three times a day"
11190290|NCT02124759|EG001|Reported Event|Sevelamer|Sevelamer: 1.6 g sevelamer + 4.4 g maltodextrin three times a day that were fed either a low fat or high fat diet, followed by the other type of diet.
11190291|NCT02124759|EG002|Reported Event|Synbiotic|Synbiotic: 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day that were fed either a low fat or high fat diet, followed by the other type of diet.
11190292|NCT02124772|BG000|Baseline|Part A - TMT 0.0125 mg/kg/Day|Participants treated with trametinib 0.0125 mg/kg/day
11190293|NCT02124772|BG001|Baseline|Part A - TMT 0.025 mg/kg/Day|Participants treated with trametinib 0.025 mg/kg/day
11190294|NCT02124772|BG002|Baseline|Part A - TMT 0.032 mg/kg/Day|Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
11190295|NCT02124772|BG003|Baseline|Part A - TMT 0.04 mg/kg/Day|Participants treated with trametinib 0.04 mg/kg/day
11372088|NCT02090114|FG003|Participant Flow|Cohort D: Mutation|"Men with metastatic prostate cancer who have castrate resistant prostate cancer with inactivating somatic or germline mutations in the genes TP53, RB1 or PTEN identified using clinical grade sequencing of tumor tissue performed by qualified laboratory. Patients must have mutations in ≥2 of these genes to be eligible. Eligible patients must have progressed on first line hormone therapy with LHRH agonist alone and must have received at least one but not more than two second generation androgen ablative therapy (i.e. Abiraterone, Enzalutamide or Apalutamide).~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11372089|NCT02090114|OG000|Outcome|Cohort A:Post-enzalutamide|"Men with castration-resistant prostate cancer who have progressed on enzalutamide will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with enzalutamide 160 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Enzalutamide: XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides."
11372090|NCT02090114|OG001|Outcome|Cohort B: Post-abiraterone|"Men with castration-resistant prostate cancer who have progressed on abiraterone will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with abiraterone 1000 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Abiraterone acetate: Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate."
11372091|NCT02090114|OG002|Outcome|Cohort C: Castration Only|"Men with metastatic prostate cancer who have only received first line hormone therapy with LHRH agonist alone or LHRH agonist plus an anti-androgen. Patients who have developed castrate resistance to first line therapy and have then received second line hormone therapy of any kind (including flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone, enzalutamide, ARN-509 and investigational anti-androgens) are not eligible for enrollment in this cohort.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11376353|NCT00567580|BG001|Baseline|PBRT + STAD|Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376354|NCT00567580|BG002|Baseline|PLNRT + PBRT + STAD|Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376355|NCT00567580|BG003|Baseline|Total|Total of all reporting groups
11190296|NCT02124772|BG004|Baseline|Part B - Neuroblastoma|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190297|NCT02124772|BG005|Baseline|Part B - LGG Fusion|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11372092|NCT02090114|OG003|Outcome|Cohort D: Mutation|"Men with metastatic prostate cancer who have castrate resistant prostate cancer with inactivating somatic or germline mutations in the genes TP53, RB1 or PTEN identified using clinical grade sequencing of tumor tissue performed by qualified laboratory. Patients must have mutations in ≥2 of these genes to be eligible. Eligible patients must have progressed on first line hormone therapy with LHRH agonist alone and must have received at least one but not more than two second generation androgen ablative therapy (i.e. Abiraterone, Enzalutamide or Apalutamide).~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11372093|NCT02090114|EG000|Reported Event|Cohort A:Post-enzalutamide|"Men with castration-resistant prostate cancer who have progressed on enzalutamide will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with enzalutamide 160 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Enzalutamide: XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides."
11372094|NCT02090114|EG001|Reported Event|Cohort B: Post-abiraterone|"Men with castration-resistant prostate cancer who have progressed on abiraterone will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with abiraterone 1000 mg by mouth daily.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days.~Abiraterone acetate: Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate."
11372095|NCT02090114|EG002|Reported Event|Cohort C: Castration Only|"Men with metastatic prostate cancer who have only received first line hormone therapy with LHRH agonist alone or LHRH agonist plus an anti-androgen. Patients who have developed castrate resistance to first line therapy and have then received second line hormone therapy of any kind (including flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone, enzalutamide, ARN-509 and investigational anti-androgens) are not eligible for enrollment in this cohort.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11376356|NCT00567580|FG000|Participant Flow|PBRT Alone|Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
11376357|NCT00567580|FG001|Participant Flow|PBRT + STAD|Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11372096|NCT02090114|EG003|Reported Event|Cohort D: Mutation|"Men with metastatic prostate cancer who have castrate resistant prostate cancer with inactivating somatic or germline mutations in the genes TP53, RB1 or PTEN identified using clinical grade sequencing of tumor tissue performed by qualified laboratory. Patients must have mutations in ≥2 of these genes to be eligible. Eligible patients must have progressed on first line hormone therapy with LHRH agonist alone and must have received at least one but not more than two second generation androgen ablative therapy (i.e. Abiraterone, Enzalutamide or Apalutamide).~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate and will be administered at 400mg IM every 28 days.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative. Will be administered at 400mg IM every 28 days."
11372097|NCT01915498|BG000|Baseline|Phase 1 Dose Escalation: Enasidenib 30 mg BID|Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372098|NCT01915498|BG001|Baseline|Phase 1 Dose Escalation: Enasidenib 50 mg BID|Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372099|NCT01915498|BG002|Baseline|Phase 1 Dose Escalation: Enasidenib 75 mg BID|Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372100|NCT01915498|BG003|Baseline|Phase 1 Dose Escalation: Enasidenib 100 mg BID|Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372101|NCT01915498|BG004|Baseline|Phase 1 Dose Escalation: Enasidenib 150 mg BID|Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372102|NCT01915498|BG005|Baseline|Phase 1 Dose Escalation: Enasidenib 50 mg QD|Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372103|NCT01915498|BG006|Baseline|Phase 1 Dose Escalation: Enasidenib 75 mg QD|Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372104|NCT01915498|BG007|Baseline|Phase 1 Dose Escalation: Enasidenib 100 mg QD|Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372105|NCT01915498|BG008|Baseline|Phase 1 Dose Escalation: Enasidenib 150 mg QD|Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372106|NCT01915498|BG009|Baseline|Phase 1 Dose Escalation: Enasidenib 200 mg QD|Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372107|NCT01915498|BG010|Baseline|Phase 1 Dose Escalation: Enasidenib 300 mg QD|Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372108|NCT01915498|BG011|Baseline|Phase 1 Dose Escalation: Enasidenib 450 mg QD|Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372109|NCT01915498|BG012|Baseline|Phase 1 Dose Escalation: Enasidenib 650 mg QD|Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372110|NCT01915498|BG013|Baseline|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD|Participants ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372111|NCT01915498|BG014|Baseline|Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD|Participants < 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372112|NCT01915498|BG015|Baseline|Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD|Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372113|NCT01915498|BG016|Baseline|Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD|Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372114|NCT01915498|BG017|Baseline|Phase 2: Enasidenib 100 mg QD|Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372115|NCT01915498|BG018|Baseline|Total|Total of all reporting groups
11372116|NCT01915498|FG000|Participant Flow|Phase 1 Dose Escalation: Enasidenib 30 mg BID|Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372117|NCT01915498|FG001|Participant Flow|Phase 1 Dose Escalation: Enasidenib 50 mg BID|Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372118|NCT01915498|FG002|Participant Flow|Phase 1 Dose Escalation: Enasidenib 75 mg BID|Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372119|NCT01915498|FG003|Participant Flow|Phase 1 Dose Escalation: Enasidenib 100 mg BID|Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372120|NCT01915498|FG004|Participant Flow|Phase 1 Dose Escalation: Enasidenib 150 mg BID|Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372121|NCT01915498|FG005|Participant Flow|Phase 1 Dose Escalation: Enasidenib 50 mg QD|Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372122|NCT01915498|FG006|Participant Flow|Phase 1 Dose Escalation: Enasidenib 75 mg QD|Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372123|NCT01915498|FG007|Participant Flow|Phase 1 Dose Escalation: Enasidenib 100 mg QD|Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372124|NCT01915498|FG008|Participant Flow|Phase 1 Dose Escalation: Enasidenib 150 mg QD|Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372125|NCT01915498|FG009|Participant Flow|Phase 1 Dose Escalation: Enasidenib 200 mg QD|Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372126|NCT01915498|FG010|Participant Flow|Phase 1 Dose Escalation: Enasidenib 300 mg QD|Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372127|NCT01915498|FG011|Participant Flow|Phase 1 Dose Escalation: Enasidenib 450 mg QD|Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372128|NCT01915498|FG012|Participant Flow|Phase 1 Dose Escalation: Enasidenib 650 mg QD|Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372129|NCT01915498|FG013|Participant Flow|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD|Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372130|NCT01915498|FG014|Participant Flow|Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD|Participants < 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372131|NCT01915498|FG015|Participant Flow|Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD|Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372132|NCT01915498|FG016|Participant Flow|Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD|Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372133|NCT01915498|FG017|Participant Flow|Phase 2: Enasidenib 100 mg QD|Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372134|NCT01915498|FG018|Participant Flow|Safety Follow-Up: Enasidenib|Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372135|NCT01915498|OG000|Outcome|Phase 1 Dose Escalation: Enasidenib 30 mg BID|Participants received enasidenib 30 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372136|NCT01915498|OG001|Outcome|Phase 1 Dose Escalation: Enasidenib 50 mg BID|Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372137|NCT01915498|OG002|Outcome|Phase 1 Dose Escalation: Enasidenib 75 mg BID|Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372138|NCT01915498|OG003|Outcome|Phase 1 Dose Escalation: Enasidenib 100 mg BID|Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372139|NCT01915498|OG004|Outcome|Phase 1 Dose Escalation: Enasidenib 150 mg BID|Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372140|NCT01915498|OG005|Outcome|Phase 1 Dose Escalation: Enasidenib 50 mg QD|Participants received enasidenib 50 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372141|NCT01915498|OG006|Outcome|Phase 1 Dose Escalation: Enasidenib 75 mg QD|Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372142|NCT01915498|OG007|Outcome|Phase 1 Dose Escalation: Enasidenib 100 mg QD|Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372143|NCT01915498|OG008|Outcome|Phase 1 Dose Escalation: Enasidenib 150 mg QD|Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372144|NCT01915498|OG009|Outcome|Phase 1 Dose Escalation: Enasidenib 200 mg QD|Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372145|NCT01915498|OG010|Outcome|Phase 1 Dose Escalation: Enasidenib 300 mg QD|Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372146|NCT01915498|OG011|Outcome|Phase 1 Dose Escalation: Enasidenib 450 mg QD|Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372147|NCT01915498|OG012|Outcome|Phase 1 Dose Escalation: Enasidenib 650 mg QD|Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372148|NCT01915498|OG000|Outcome|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD|Participants ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372149|NCT01915498|OG001|Outcome|Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD|Participants < 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372150|NCT01915498|OG002|Outcome|Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD|Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372151|NCT01915498|OG003|Outcome|Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD|Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372152|NCT01915498|OG000|Outcome|Phase 2: Enasidenib 100 mg QD|Participants with relapsed or refractory (R/R) AML received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372153|NCT01915498|OG000|Outcome|Safety Follow-up: Enasidenib|Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372154|NCT01915498|OG000|Outcome|Phase 1 Dose Escalation: Enasidenib 50 mg|Participants received enasidenib 50 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372155|NCT01915498|OG001|Outcome|Phase 1 Dose Escalation: Enasidenib 60 mg|Participants who received a total daily dose of enasidenib 60 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372156|NCT01915498|OG002|Outcome|Phase 1 Dose Escalation: Enasidenib 75 mg|Participants who received a total daily dose of enasidenib 75 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372157|NCT01915498|OG003|Outcome|Phase 1 Dose Escalation: Enasidenib 100 mg|Participants who received a total daily dose of enasidenib 100 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372158|NCT01915498|OG004|Outcome|Phase 1 Dose Escalation: Enasidenib 150 mg|Participants who received a total daily dose of enasidenib 150 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372159|NCT01915498|OG005|Outcome|Phase 1 Dose Escalation: Enasidenib 200 mg|Participants who received a total daily dose of enasidenib 200 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372160|NCT01915498|OG006|Outcome|Phase 1 Dose Escalation: Enasidenib 300 mg|Participants who received a total daily dose of enasidenib 300 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372161|NCT01915498|OG007|Outcome|Phase 1 Dose Escalation: Enasidenib 450 mg|Participants who received a total daily dose of enasidenib 450 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372162|NCT01915498|OG008|Outcome|Phase 1 Dose Escalation: Enasidenib 650 mg|Participants who received a total daily dose of enasidenib 650 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372163|NCT01915498|OG000|Outcome|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD|Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372164|NCT01915498|OG001|Outcome|Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD|Participants < 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372165|NCT01915498|OG000|Outcome|Enasidenib 100 mg QD|Participants in Phase 1 or 2 with relapsed or refractory (R/R) AML who received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11190298|NCT02124772|BG006|Baseline|Part B - NF-1 With PN|Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
11372166|NCT01915498|OG000|Outcome|Phase 1 Dose Escalation: Enasidenib 50 mg|Participants received enasidenib 50 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372167|NCT01915498|OG000|Outcome|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg|Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372168|NCT01915498|OG000|Outcome|Phase 1: Enasidenib - R/R AML|Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion with R/R AML who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372169|NCT01915498|OG001|Outcome|Phase 1: Enasidenib|Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372170|NCT01915498|OG001|Outcome|Phase 1 Dose Escalation: Enasidenib 60 mg|Participants received enasidenib 60 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372171|NCT01915498|OG002|Outcome|Phase 1 Dose Escalation: Enasidenib 75 mg|Participants received enasidenib 75 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372172|NCT01915498|OG003|Outcome|Phase 1 Dose Escalation: Enasidenib 100 mg|Participants received enasidenib 100 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372173|NCT01915498|OG004|Outcome|Phase 1 Dose Escalation: Enasidenib 150 mg|Participants received enasidenib 150 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372174|NCT01915498|OG005|Outcome|Phase 1 Dose Escalation: Enasidenib 200 mg|Participants received enasidenib 200 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372175|NCT01915498|OG006|Outcome|Phase 1 Dose Escalation: Enasidenib 300 mg|Participants received enasidenib 300 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372176|NCT01915498|OG007|Outcome|Phase 1 Dose Escalation: Enasidenib 450 mg|Participants received enasidenib 450 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372177|NCT01915498|OG008|Outcome|Phase 1 Dose Escalation: Enasidenib 650 mg|Participants received enasidenib 650 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372178|NCT01915498|OG000|Outcome|Enasidenib 30 mg|Participants received a single oral dose of enasidenib 30 mg on Day -3.
11372179|NCT01915498|OG001|Outcome|Enasidenib 50 mg|Participants received a single oral dose of enasidenib 50 mg on Day -3.
11372180|NCT01915498|OG002|Outcome|Enasidenib 75 mg|Participants received a single oral dose of enasidenib 75 mg on Day -3.
11372181|NCT01915498|OG003|Outcome|Enasidenib 100 mg|Participants received a single oral dose of enasidenib 100 mg on Day -3.
11372182|NCT01915498|OG004|Outcome|Enasidenib 150 mg|Participants received a single oral dose of enasidenib 150 mg on Day -3.
11372183|NCT01915498|OG005|Outcome|Enasidenib 200 mg|Participants received a single oral dose of enasidenib 200 mg on Day -3.
11372184|NCT01915498|OG006|Outcome|Enasidenib 300 mg|Participants received a single oral dose of enasidenib 300 mg on Day -3.
11372185|NCT01915498|OG007|Outcome|Enasidenib 450 mg|Participants received a single oral dose of enasidenib 450 mg on Day -3.
11372186|NCT01915498|OG008|Outcome|Enasidenib 650 mg|Participants received a single oral dose of enasidenib 650 mg on Day -3.
11372187|NCT01915498|OG000|Outcome|Enasidenib 30 mg BID|Participants received enasidenib 30 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372188|NCT01915498|OG001|Outcome|Enasidenib 50 mg BID|Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372189|NCT01915498|OG002|Outcome|Enasidenib 75 mg BID|Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372190|NCT01915498|OG003|Outcome|Enasidenib 100 mg BID|Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity
11372191|NCT01915498|OG004|Outcome|Enasidenib 150 mg BID|Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372192|NCT01915498|OG005|Outcome|Enasidenib 50 mg QD|Participants received enasidenib 50 mg tablets every day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372193|NCT01915498|OG006|Outcome|Enasidenib 75 mg QD|Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372194|NCT01915498|OG007|Outcome|Enasidenib 100 mg QD|Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372195|NCT01915498|OG008|Outcome|Enasidenib 150 mg QD|Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372196|NCT01915498|OG009|Outcome|Enasidenib 200 mg QD|Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372197|NCT01915498|OG010|Outcome|Enasidenib 300 mg QD|Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372198|NCT01915498|OG011|Outcome|Enasidenib 450 mg QD|Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372199|NCT01915498|OG012|Outcome|Enasidenib 650 mg QD|Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372200|NCT01915498|OG000|Outcome|Phase 2: Enasidenib 100 mg QD|Participants received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372201|NCT01915498|OG000|Outcome|Phase 1 and 2: Enasidenib 100 mg QD|Participants in Phase 1 and 2 who received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372202|NCT01915498|EG000|Reported Event|Phase 1 Dose Escalation: Enasidenib 30 mg BID|Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372203|NCT01915498|EG001|Reported Event|Phase 1 Dose Escalation: Enasidenib 50 mg BID|Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372204|NCT01915498|EG002|Reported Event|Phase 1 Dose Escalation: Enasidenib 75 mg BID|Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372205|NCT01915498|EG003|Reported Event|Phase 1 Dose Escalation: Enasidenib 100 mg BID|Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372206|NCT01915498|EG004|Reported Event|Phase 1 Dose Escalation: Enasidenib 150 mg BID|Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372207|NCT01915498|EG005|Reported Event|Phase 1 Dose Escalation: Enasidenib 50 mg QD|Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372208|NCT01915498|EG006|Reported Event|Phase 1 Dose Escalation: Enasidenib 75 mg QD|Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372209|NCT01915498|EG007|Reported Event|Phase 1 Dose Escalation: Enasidenib 100 mg QD|Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372210|NCT01915498|EG008|Reported Event|Phase 1 Dose Escalation: Enasidenib 150 mg QD|Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372211|NCT01915498|EG009|Reported Event|Phase 1 Dose Escalation: Enasidenib 200 mg QD|Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372212|NCT01915498|EG010|Reported Event|Phase 1 Dose Escalation: Enasidenib 300 mg QD|Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372213|NCT01915498|EG011|Reported Event|Phase 1 Dose Escalation: Enasidenib 450 mg QD|Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372214|NCT01915498|EG012|Reported Event|Phase 1 Dose Escalation: Enasidenib 650 mg QD|Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372215|NCT01915498|EG013|Reported Event|Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD|Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372216|NCT01915498|EG014|Reported Event|Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD|Participants < 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372217|NCT01915498|EG015|Reported Event|Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD|Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372218|NCT01915498|EG016|Reported Event|Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD|Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372219|NCT01915498|EG017|Reported Event|Phase 2: Enasidenib 100 mg QD|Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372220|NCT01915498|EG018|Reported Event|Safety Follow-Up: Enasidenib|Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
11372221|NCT01568424|BG000|Baseline|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
11372222|NCT01568424|FG000|Participant Flow|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
11372223|NCT01568424|OG000|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
11372224|NCT01568424|EG000|Reported Event|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
11372225|NCT00819793|BG000|Baseline|CentriMag Ventricular Assist System|"All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.~CentriMag Ventricular Assist System: All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration."
11372226|NCT00819793|FG000|Participant Flow|Patients Supported by the CentriMag Ventricular Assist System|"All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.~Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration."
11372227|NCT00819793|OG000|Outcome|Patients Supported by the CentriMag Ventricular Assist System|"All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.~Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration."
11372228|NCT00819793|OG000|Outcome|Subjects Supported With CentriMag|
11372229|NCT00819793|EG000|Reported Event|Patients Supported by the CentriMag Ventricular Assist System|"All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.~Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration."
11372230|NCT00121485|BG000|Baseline|HeartMate II|Implantation of HeartMate II LVAS
11372231|NCT00121485|BG001|Baseline|HeartMate XVE|Implantation of HeartMate XVE LVAS
11372232|NCT00121485|BG002|Baseline|Total|Total of all reporting groups
11372233|NCT00121485|FG000|Participant Flow|HeartMate II|Implantation of HeartMate II LVAS
11372234|NCT00121485|FG001|Participant Flow|HeartMate XVE|Implantation of HeartMate XVE LVAS
11372235|NCT00121485|OG000|Outcome|HeartMate II|Implantation of HeartMate II LVAS
11372236|NCT00121485|OG001|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
11372237|NCT00121485|OG001|Outcome|HeartMate XVE|Implantation of HeartMate XVE
11372238|NCT00121485|EG000|Reported Event|HeartMate II|Implantation of HeartMate II LVAS
11372239|NCT00121485|EG001|Reported Event|HeartMate XVE|Implantation of HeartMate XVE LVAS
11372240|NCT00121472|BG000|Baseline|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
11372241|NCT00121472|FG000|Participant Flow|HeartMate II (HMII)|HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
11372242|NCT00121472|OG000|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
11372243|NCT00121472|OG000|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
11372244|NCT00121472|OG000|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
11372245|NCT00121472|OG000|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
11372246|NCT00121472|OG000|Outcome|HMII Replacement|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
11372247|NCT00121472|EG000|Reported Event|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
11376358|NCT00567580|FG002|Participant Flow|PLNRT + PBRT + STAD|Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376359|NCT00567580|OG000|Outcome|PBRT Alone|(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
11376360|NCT00567580|OG001|Outcome|PBRT + STAD|(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376361|NCT00567580|OG002|Outcome|PLNRT + PBRT + STAD|(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376362|NCT00567580|OG000|Outcome|PBRT Alone|Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
11376363|NCT00567580|OG001|Outcome|PBRT + STAD|Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11372248|NCT00078806|BG000|Baseline|Part 1: Etanercept|"Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.~Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months."
11372249|NCT00078806|FG000|Participant Flow|Part 1: Etanercept|"Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.~Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months."
11372250|NCT00078806|FG001|Participant Flow|Part 2: Placebo|Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
11372251|NCT00078806|FG002|Participant Flow|Part 2: Etanercept|Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.
11372252|NCT00078806|FG003|Participant Flow|Part 3: Etanercept|Participants who experienced a flare in Part 2 or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including Part 2.
11372253|NCT00078806|OG000|Outcome|Part 2: Placebo|Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
11372254|NCT00078806|OG001|Outcome|Part 2: Etanercept|Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.
11372255|NCT00078806|OG000|Outcome|Part 1A: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.
11372256|NCT00078806|OG001|Outcome|Part 1B: Etanercept 0.8 mg/kg|Participants in Part A1 who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months.
11372257|NCT00078806|OG002|Outcome|Part 2: Placebo|Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
11372258|NCT00078806|OG003|Outcome|Part 2: Etanercept|Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.
11372259|NCT00078806|OG004|Outcome|Part 3: Etanercept|Participants who experienced a flare in Part 2 or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including Part 2.
11372260|NCT00078806|OG000|Outcome|Part 1: Etanercept|"Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.~Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months."
11372261|NCT00078806|EG000|Reported Event|Part 1A: Etanercept 0.4 mg/kg|Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.
11372262|NCT00078806|EG001|Reported Event|Part 1B: Etanercept 0.8 mg/kg|Participants who had a partial response in Part 1A entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months.
11372263|NCT00078806|EG002|Reported Event|Part 2: Placebo|Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months in Part 2.
11372264|NCT00078806|EG003|Reported Event|Part 2: Etanercept 0.4/0.8 mg/kg|Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months in Part 2.
11372265|NCT00078806|EG004|Reported Event|Part 3: Etanercept 0.4/0.8 mg/kg|Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment received in Part 2.
11372266|NCT00162370|BG000|Baseline|Definity|"Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11372267|NCT00162370|FG000|Participant Flow|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11372268|NCT00162370|OG000|Outcome|Definity|"Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11372269|NCT00162370|OG000|Outcome|Definity|"All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11372270|NCT00162370|OG000|Outcome|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11372271|NCT00162370|OG000|Outcome|Subjects Undergoing Clinically-indicated Angiography|Subset of the enrolled population who underwent angiography as part of their care.
11190299|NCT02124772|BG007|Baseline|Part B - BRAF V600 Mutant Solid Tumor|Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
11190300|NCT02124772|BG008|Baseline|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11372272|NCT00162370|EG000|Reported Event|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
11376364|NCT00567580|OG002|Outcome|PLNRT + PBRT + STAD|Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376365|NCT00567580|EG000|Reported Event|PBRT Alone|Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
11376366|NCT00567580|EG001|Reported Event|PBRT + STADT|Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376367|NCT00567580|EG002|Reported Event|PLNRT + PBRT + STADT|Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
11376368|NCT00528021|BG000|Baseline|2.5% BGC20-0582|
11376369|NCT00528021|BG001|Baseline|10% BGC20-0582|
11376370|NCT00528021|BG002|Baseline|12.5% BGC20-0582|
11376371|NCT00528021|BG003|Baseline|Vehicle|
11376372|NCT00528021|BG004|Baseline|Total|Total of all reporting groups
11376373|NCT00528021|FG000|Participant Flow|2.5% BGC20-0582|"Active Comparator: 1~Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BG20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376374|NCT00528021|FG001|Participant Flow|10% BGC20-0582|"Active Comparator: 2~Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376375|NCT00528021|FG002|Participant Flow|12.5% BGC20-0582|"Active Comparator: 3~Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376376|NCT00528021|FG003|Participant Flow|Vehicle|Placebo Comparator: 4
11376377|NCT00528021|OG000|Outcome|2.5% BGC20-0582|"Active Comparator: 1~Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 2.% BGC20-582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376378|NCT00528021|OG001|Outcome|10% BGC20-0582|"Active Comparator: 2~Subject's are treated either once (day 1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376379|NCT00528021|OG002|Outcome|12.5% BGC20-0582|"Active Comparator: 3~Subject's are treated either once (day 1) or twice (day 1 and 7) with either placebo or 12.5% BG20-0582 TOPICALLY. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair."
11376380|NCT00528021|OG003|Outcome|Vehicle|Placebo Comparator: 4
11376381|NCT00528021|EG000|Reported Event|2.5% BGC20-0582|
11376382|NCT00528021|EG001|Reported Event|10% BGC20-0582|
11376383|NCT00528021|EG002|Reported Event|12.5% BGC20-0582|
11376384|NCT00528021|EG003|Reported Event|Vehicle|
11376385|NCT00485693|BG000|Baseline|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
11376386|NCT00485693|BG001|Baseline|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
11376387|NCT00485693|BG002|Baseline|Total|Total of all reporting groups
11376388|NCT00485693|FG000|Participant Flow|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
11376389|NCT00485693|FG001|Participant Flow|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
11376390|NCT00485693|OG000|Outcome|Bupivacaine HCl|Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
11376391|NCT00485693|OG001|Outcome|SKY0402 Low Dose|Single administration of SKY0402150 mg in a volume of 60 mL via local infiltration
11376392|NCT00485693|OG002|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 300mg in a volume of 60 mL via local infiltration
11376393|NCT00485693|OG003|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 450 mg in a volume of 60 mL via local infiltration
11376394|NCT00485693|OG004|Outcome|SKY0402 High Dose|Single administration of SKY0402 600mg in a volume of 60 mL via local infiltration
11376395|NCT00485693|EG000|Reported Event|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
11376396|NCT00485693|EG001|Reported Event|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
11376397|NCT00390325|BG000|Baseline|Arm A (Hereditary MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11376398|NCT00390325|BG001|Baseline|Arm B (Sporadic MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11376399|NCT00390325|BG002|Baseline|Total|Total of all reporting groups
11376400|NCT00390325|FG000|Participant Flow|Arm A (Hereditary MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11190301|NCT02124772|BG009|Baseline|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190302|NCT02124772|BG010|Baseline|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11372273|NCT00204737|BG000|Baseline|Prednisone|"Prednisone 20mg daily x 2 weeks~prednisone: 20mg x 2 weeks"
11372274|NCT00204737|BG001|Baseline|Placebo|"placebo~placebo: placebo"
11372275|NCT00204737|BG002|Baseline|Total|Total of all reporting groups
11372276|NCT00204737|FG000|Participant Flow|Prednisone|"Prednisone 20mg daily x 2 weeks~prednisone: 20mg x 2 weeks"
11372277|NCT00204737|FG001|Participant Flow|Placebo|"placebo~placebo: placebo"
11372278|NCT00204737|OG000|Outcome|Prednisone|"Prednisone 20mg daily x 2 weeks~prednisone: 20mg x 2 weeks"
11372279|NCT00204737|OG001|Outcome|Placebo|"placebo~placebo: placebo"
11372280|NCT00204737|EG000|Reported Event|Prednisone|"Prednisone 20mg daily x 2 weeks~prednisone: 20mg x 2 weeks"
11372281|NCT00204737|EG001|Reported Event|Placebo|"placebo~placebo: placebo"
11372282|NCT00214500|BG000|Baseline|Migalastat|"Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.~Treatment Period:~Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).~Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).~Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).~Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).~Extension Period:~Migalastat 25 mg BID for Weeks 12 through 48.~Migalastat 50 mg QD for Weeks 48 through 96."
11372283|NCT00214500|FG000|Participant Flow|Migalastat|"Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.~Treatment Period:~Migalastat 25 milligrams (mg) twice a day (BID) for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).~Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).~Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).~Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).~Extension Period:~Migalastat 25 mg BID for Weeks 12 through 48.~Migalastat 50 mg once a day (QD) for Weeks 48 through 96."
11372284|NCT00214500|OG000|Outcome|Migalastat|"Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.~Treatment Period:~Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).~Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).~Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).~Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).~Extension Period:~Migalastat 25 mg BID for Weeks 12 through 48.~Migalastat 50 mg QD for Weeks 48 through 96."
11372285|NCT00214500|OG000|Outcome|Migalastat 25 mg|Migalastat was administered orally. Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
11190303|NCT02124772|BG011|Baseline|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190304|NCT02124772|BG012|Baseline|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190305|NCT02124772|BG013|Baseline|Total|Total of all reporting groups
11190306|NCT02124772|FG000|Participant Flow|Part A - TMT 0.0125 mg/kg/Day|Participants treated with trametinib 0.0125 mg/kg/day
11190307|NCT02124772|FG001|Participant Flow|Part A - TMT 0.025 mg/kg/Day|Participants treated with trametinib 0.025 mg/kg/day
11190308|NCT02124772|FG002|Participant Flow|Part A - TMT 0.032 mg/kg/Day|Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
11190309|NCT02124772|FG003|Participant Flow|Part A - TMT 0.04 mg/kg/Day|Participants treated with trametinib 0.04 mg/kg/day
11190310|NCT02124772|FG004|Participant Flow|Part B - Neuroblastoma|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190311|NCT02124772|FG005|Participant Flow|Part B - LGG Fusion|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190312|NCT02124772|FG006|Participant Flow|Part B - NF-1 With PN|Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
11372286|NCT00214500|OG001|Outcome|Migalastat 100 mg|Migalastat was administered orally. Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
11372287|NCT00214500|OG002|Outcome|Migalastat 250 mg|Migalastat was administered orally. Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
11372288|NCT00214500|EG000|Reported Event|Migalastat|"Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.~Treatment Period:~Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).~Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).~Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).~Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).~Extension Period:~Migalastat 25 mg BID for Weeks 12 through 48.~Migalastat 50 mg QD for Weeks 48 through 96."
11372289|NCT00278343|BG000|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
11372290|NCT00278343|FG000|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
11372291|NCT00278343|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
11372292|NCT00278343|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: 30mg given PO, daily"
11372293|NCT00278343|EG000|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
11376401|NCT00390325|FG001|Participant Flow|Arm B (Sporadic MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11376402|NCT00390325|OG000|Outcome|Arm A (Hereditary MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11376403|NCT00390325|OG001|Outcome|Arm B (Sporadic MTC)|Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
11376404|NCT00390325|OG000|Outcome|Arm A (Hereditary MTC)|"Arm A:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis."
11376405|NCT00390325|OG001|Outcome|Arm B (Sporadic MTC)|"Arm B:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis."
11376406|NCT00390325|OG000|Outcome|Arm A (Hereditary MTC) and Arm B (Sporadic MTC)|"Arm A:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.~Arm B:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis."
11376407|NCT00390325|OG000|Outcome|Arm A|MTC in setting of inherited syndromes (MEN-2A, 2B or FMTC) plus Measurable disease Plus No prior ZD6474 or AMG 706
11376408|NCT00390325|OG001|Outcome|Arm B|MTC in setting of sporadic ds plus Measurable disease Plus No prior ZD6474 or AMG 706
11376409|NCT00390325|EG000|Reported Event|Arm A (Hereditary MTC) and Arm B (Sporadic MTC)|"Arm A:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.~Arm B:~Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis."
11376410|NCT00381641|BG000|Baseline|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376411|NCT00381641|BG001|Baseline|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376412|NCT00381641|BG002|Baseline|Total|Total of all reporting groups
11376413|NCT00381641|FG000|Participant Flow|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376414|NCT00381641|FG001|Participant Flow|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376415|NCT00381641|OG000|Outcome|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376416|NCT00381641|OG001|Outcome|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376417|NCT00381641|EG000|Reported Event|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376418|NCT00381641|EG001|Reported Event|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
11376419|NCT00114101|BG000|Baseline|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
11376420|NCT00114101|BG001|Baseline|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
11376421|NCT00114101|BG002|Baseline|Total|Total of all reporting groups
11376422|NCT00114101|FG000|Participant Flow|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
11376423|NCT00114101|FG001|Participant Flow|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
11376424|NCT00114101|OG000|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
11376425|NCT00114101|OG001|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
11376426|NCT00114101|OG000|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily.
11376427|NCT00114101|OG001|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily.~(closed as of 12/17/09)"
11376428|NCT00114101|EG000|Reported Event|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
11372294|NCT00283959|BG000|Baseline|Migalastat|Participants received migalastat 150 mg orally QOD during the 12-week treatment period and the optional 36-week extension period.
11372295|NCT00283959|FG000|Participant Flow|Migalastat|Participants received migalastat 150 milligrams (mg) orally every other day (QOD) during the 12-week treatment period and the optional 36-week extension period.
11372296|NCT00283959|OG000|Outcome|Migalastat|Participants received migalastat 150 mg orally QOD during the 12-week treatment period and the optional 36-week extension period.
11372297|NCT00283959|EG000|Reported Event|Migalastat|Participants received migalastat 150 mg orally QOD during the 12-week treatment period and the optional 36-week extension period.
11372298|NCT00290758|BG000|Baseline|Arm A|Patients receive oral genistein once daily for up to 6 months.
11372299|NCT00290758|BG001|Baseline|Arm B|Patients receive oral placebo once daily for up to 6 months.
11372300|NCT00290758|BG002|Baseline|Total|Total of all reporting groups
11372301|NCT00290758|FG000|Participant Flow|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
11372302|NCT00290758|FG001|Participant Flow|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
11372303|NCT00290758|OG000|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
11372304|NCT00290758|OG001|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
11372305|NCT00290758|OG000|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
11372306|NCT00290758|OG001|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
11372307|NCT00290758|OG000|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
11372308|NCT00290758|OG001|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
11372309|NCT00290758|EG000|Reported Event|Arm A (Genistein)|Patients take oral genistein once daily for up to 6 months.
11372310|NCT00290758|EG001|Reported Event|Arm B (Placebo)|Patients take oral placebo once daily for up to 6 months.
11372311|NCT00310388|BG000|Baseline|Retigabine|Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
11372312|NCT00310388|FG000|Participant Flow|Retigabine|Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 milligrams (mg) three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) up to 121 months.
11372313|NCT00310388|FG001|Participant Flow|Safety Follow-up Continuation Phase (SFUCP)|Participants who withdraw from retigabine and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of nails, lips, skin or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
11372314|NCT00310388|OG000|Outcome|Retigabine|Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
11372315|NCT00310388|OG000|Outcome|SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
11372316|NCT00310388|EG000|Reported Event|Retigabine|Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
11372317|NCT00345358|BG000|Baseline|Synflorix <6M Group|This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372318|NCT00345358|BG001|Baseline|Synflorix 7-11M Group|This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372319|NCT00345358|BG002|Baseline|Synflorix 12-23M Group|This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372320|NCT00345358|BG003|Baseline|Synflorix >=24M Group|This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372321|NCT00345358|BG004|Baseline|Total|Total of all reporting groups
11372322|NCT00345358|FG000|Participant Flow|Synflorix <6M Group|This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372323|NCT00345358|FG001|Participant Flow|Synflorix 7-11M Group|This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372324|NCT00345358|FG002|Participant Flow|Synflorix 12-23M Group|This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372325|NCT00345358|FG003|Participant Flow|Synflorix >=24M Group|This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372326|NCT00345358|OG000|Outcome|Synflorix <6M Group|This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372327|NCT00345358|OG001|Outcome|Synflorix 7-11M Group|This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372328|NCT00345358|OG002|Outcome|Synflorix 12-23M Group|This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372329|NCT00345358|OG003|Outcome|Synflorix >=24M Group|This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372330|NCT00345358|EG000|Reported Event|Synflorix <6M Group|This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372331|NCT00345358|EG001|Reported Event|Synflorix 7-11M Group|This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372332|NCT00345358|EG002|Reported Event|Synflorix 12-23M Group|This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372333|NCT00345358|EG003|Reported Event|Synflorix >=24M Group|This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
11372334|NCT00345800|BG000|Baseline|Sodium Oxybate|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
11372335|NCT00345800|FG000|Participant Flow|Sodium Oxybate|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
11372336|NCT00345800|OG000|Outcome|Sodium Oxybate|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
11372337|NCT00345800|EG000|Reported Event|Sodium Oxybate|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
11372338|NCT00372229|BG000|Baseline|Valganciclovir CMV Prophylaxis|Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372339|NCT00372229|BG001|Baseline|Pre-emptive CMV Therapy|"Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.~Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir."
11372340|NCT00372229|BG002|Baseline|Total|Total of all reporting groups
11372341|NCT00372229|FG000|Participant Flow|Valganciclovir Cytomegalovirus (CMV) Prophylaxis|Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372342|NCT00372229|FG001|Participant Flow|Pre-emptive CMV Therapy|"Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.~Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir."
11372343|NCT00372229|OG000|Outcome|Valganciclovir CMV Prophylaxis|Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372344|NCT00372229|OG001|Outcome|Pre-emptive CMV Therapy|"Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.~Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir."
11372345|NCT00372229|OG000|Outcome|Valganciclovir CMV Prophylaxis,With CMV Infection at Month 84|Participants with active CMV infection at Month 84 that had received valganciclovir cytomegalovirus (CMV) prophylaxis. Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372346|NCT00372229|OG001|Outcome|Valganciclovir CMV Prophylaxis, No CMV Infection at Month 84|Participants without active CMV infection at Month 84 that had received valganciclovir cytomegalovirus (CMV) prophylaxis. Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372347|NCT00372229|OG000|Outcome|Pre-emptive CMV Therapy, With CMV Infection at Month 84|Participants with active CMV infection at Month 84 received valganciclovir pre-emptive CMV Therapy. Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function (If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir).
11372348|NCT00372229|OG001|Outcome|Pre-emptive CMV Therapy, No CMV Infection at Month 84|Participants with active CMV infection at Month 84 received valganciclovir pre-emptive CMV Therapy. Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function (If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir).
11372349|NCT00372229|EG000|Reported Event|Valganciclovir CMV Prophylaxis|Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
11372350|NCT00372229|EG001|Reported Event|Pre-emptive CMV Therapy|"Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.~Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir."
11376429|NCT00114101|EG001|Reported Event|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
11376430|NCT00026312|BG000|Baseline|Regimen A|Randomized to Regimen A - RA Only
11376431|NCT00026312|BG001|Baseline|Regimen B|Regimen B - RA + Immunotherapy
11376432|NCT00026312|BG002|Baseline|Total|Total of all reporting groups
11376433|NCT00026312|FG000|Participant Flow|Regimen A|Randomized to Regimen A - RA Only
11376434|NCT00026312|FG001|Participant Flow|Regimen B|Regimen B - RA + Immunotherapy
11376435|NCT00026312|OG000|Outcome|Regimen A|Randomized to Regimen A - RA Only
11376436|NCT00026312|OG001|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
11376437|NCT00026312|OG001|Outcome|Regimen B|Regimen B - RA + Immunotherapy
11372351|NCT00383708|BG000|Baseline|Lanreotide Autogel + Pegvisomant Co-administration|Eligible subjects were entered into the co-administration period during which they received both lanreotide Autogel and pegvisomant concomitantly for 28 weeks. The lanreotide Autogel dose during the co-administration period was fixed at 120 mg and was administered by one deep s.c. injection every 28 days. Pegvisomant was administered once or twice a week via s.c. injection. The starting dose was 60 mg once a week dose. Dose adaptation of pegvisomant could then be made every 8 weeks based on IGF-1 levels taken 4 weeks after previous dose adaptation and by the third titration, subjects could receive either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week.
11372352|NCT00383708|FG000|Participant Flow|All Subjects|Subjects confirmed as eligible for the study were entered into a run-in period of 16 weeks during which they received one deep subcutaneous (s.c.) injection of lanreotide Autogel 120 mg every 28 days. If after completion of the run-in period, subjects met the eligibility criteria for levels of serum IGF-1 (and serum growth hormone [GH] nadir), they were entered into the co-administration period during which they received both lanreotide Autogel and pegvisomant concomitantly for 28 weeks. The lanreotide Autogel dose during the co-administration period was fixed at 120 mg. Pegvisomant was administered once or twice a week via s.c. injection and the dose of could be adapted every 8 weeks based on insulin-like growth factor 1 (IGF-1) levels, following a starting dose of 60 mg once a week (dose could vary from 40 to 120 mg per week and maximum permitted dose was 60 mg twice a week).
11372353|NCT00383708|OG000|Outcome|Lanreotide Autogel + Pegvisomant Co-administration|Eligible subjects were entered into the co-administration period during which they received both lanreotide Autogel and pegvisomant concomitantly for 28 weeks. The lanreotide Autogel dose during the co-administration period was fixed at 120 mg and was administered by one deep s.c. injection every 28 days. Pegvisomant was administered once or twice a week via s.c. injection. The starting dose was 60 mg once a week dose. Dose adaptation of pegvisomant could then be made every 8 weeks based on IGF-1 levels taken 4 weeks after previous dose adaptation and by the third titration, subjects could receive either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week.
11372354|NCT00383708|EG000|Reported Event|Run-in Period|During the 16 week run-in period, eligible subjects received one injection of lanreotide Autogel 120 mg every 28 days, administered by deep s.c. injection.
11372355|NCT00383708|EG001|Reported Event|Co-administration Period|During the 28 week co-administration period, eligible subjects received both lanreotide Autogel and pegvisomant concomitantly. The lanreotide Autogel dose during the co-administration period was fixed at 120 mg. Pegvisomant was administered once or twice a week via s.c. injection and the dose of could be adapted every 8 weeks based on IGF-1 levels, following a starting dose of 60 mg once a week (dose could vary from 40 to 120 mg per week and maximum permitted dose was 60 mg twice a week).
11372356|NCT00413699|BG000|Baseline|Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
11372357|NCT00413699|BG001|Baseline|Initial Period: Tofacitinib 10 mg BID|Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
11372358|NCT00413699|BG002|Baseline|Total|Total of all reporting groups
11372359|NCT00413699|FG000|Participant Flow|Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
11372360|NCT00413699|FG001|Participant Flow|Initial Period: Tofacitinib 10 mg BID|Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
11372361|NCT00413699|FG002|Participant Flow|Extension Period: Tofacitinib 5 mg|Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
11372362|NCT00413699|OG000|Outcome|Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
11372363|NCT00413699|OG001|Outcome|Initial Period: Tofacitinib 10 mg BID|Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
11372364|NCT00413699|OG002|Outcome|Initial Period: All Tofacitinib|All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
11372365|NCT00413699|OG000|Outcome|Extension Period: Tofacitinib 5 mg|Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
11372366|NCT00413699|OG000|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
11372367|NCT00413699|OG001|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372368|NCT00413699|OG002|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
11372369|NCT00413699|OG003|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372370|NCT00413699|OG000|Outcome|Tofacitinib 10 mg BID Continuous|Participants receiving continuous tofacitinib treatment
11372371|NCT00413699|OG001|Outcome|Tofacitinib 10 mg BID Interrupted|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372372|NCT00413699|OG000|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
11372373|NCT00413699|OG001|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372374|NCT00413699|OG000|Outcome|Tofacitinib 10 mg Continuous|Participants receiving continuous tofacitinib treatment
11372375|NCT00413699|OG000|Outcome|Tofacitinib 10 mg BID Continuous Visit 2|Participants receiving continuous tofacitinib treatment
11372376|NCT00413699|OG001|Outcome|Tofacitinib 10 mg BID Interrupted Visit 2|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372377|NCT00413699|OG002|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
11372378|NCT00413699|OG003|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372379|NCT00413699|OG004|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
11372380|NCT00413699|OG005|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372381|NCT00413699|OG005|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
11372382|NCT00413699|EG000|Reported Event|Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
11372383|NCT00413699|EG001|Reported Event|Initial Period: Tofacitinib 10 mg BID|Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
11372384|NCT00413699|EG002|Reported Event|Initial Period: All Tofacitinib|All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.
11372385|NCT00413699|EG003|Reported Event|Extension Period: Tofacitinib 5 mg|Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
11376438|NCT00026312|OG000|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
11376439|NCT00026312|OG001|Outcome|Regimen B|Patients that received RA + Immunotherapy before halting of randomization
11376440|NCT00026312|OG000|Outcome|Regimen B|Regimen B- RA + Immunotherapy
11376441|NCT00026312|EG000|Reported Event|Regimen A|Randomized to Regimen A - RA Only
11376442|NCT00026312|EG001|Reported Event|Regimen B|Regimen B - RA + Immunotherapy
11376443|NCT00006436|BG000|Baseline|Arm 1-Combination Chemo and Biological Therapy|"Combination chemo and biological therapy~Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5~Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle~Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles"
11376444|NCT00006436|FG000|Participant Flow|Arm 1-Combination Chemo and Biological Therapy|"Combination chemo and biological therapy~Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5~Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle~Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles"
11376445|NCT00006436|OG000|Outcome|Arm 1-Combination Chemo and Biological Therapy|"Combination chemo and biological therapy~Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5~Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle~Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles"
11376446|NCT00006436|OG000|Outcome|Grade 3|Grade 3 is serious.
11376447|NCT00006436|OG001|Outcome|Grade 4|Grade 4 is life threatening.
11376448|NCT00006436|OG002|Outcome|Grade 5|Grade 5 is death related to adverse event.
11376449|NCT00006436|EG000|Reported Event|Arm 1-Combination Chemo and Biological Therapy|"Combination chemo and biological therapy~Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5~Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle~Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles"
11376450|NCT00002540|BG000|Baseline|Control|Participants receive standard medical care.
11376451|NCT00002540|BG001|Baseline|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
11376452|NCT00002540|BG002|Baseline|Total|Total of all reporting groups
11376453|NCT00002540|FG000|Participant Flow|Control|Participants receive standard medical care.
11376454|NCT00002540|FG001|Participant Flow|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
11376455|NCT00002540|OG000|Outcome|Control|Participants receive standard medical care.
11376456|NCT00002540|OG001|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
11376457|NCT00002540|OG000|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
11376458|NCT00002540|EG000|Reported Event|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
11377158|NCT03853291|BG002|Baseline|Family Caregivers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11372386|NCT00435227|BG000|Baseline|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
11372387|NCT00435227|BG001|Baseline|Motavizumab 30 mg|Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
11372388|NCT00435227|BG002|Baseline|Total|Total of all reporting groups
11372389|NCT00435227|FG000|Participant Flow|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
11372390|NCT00435227|FG001|Participant Flow|Motavizumab 30 mg|Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
11372391|NCT00435227|OG000|Outcome|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
11372392|NCT00435227|OG001|Outcome|Motavizumab 30 mg|Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
11372393|NCT00435227|OG000|Outcome|Motavizumab 30 mg|Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
11372394|NCT00435227|EG000|Reported Event|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
11372395|NCT00435227|EG001|Reported Event|Motavizumab 30 mg|Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
11376459|NCT00788671|BG000|Baseline|Levonorgestrel-releasing IUD|Single arm study, 52 mg levonorgestrel (Mirena) intrauterine device
11376460|NCT00788671|FG000|Participant Flow|Treatment|Single arm study, 52 mg levonorgestrel (Mirena) intrauterine device
11376461|NCT00788671|OG000|Outcome|Treatment|Single arm study, 52 mg levonorgestrel (Mirena) intrauterine device
11376462|NCT00788671|EG000|Reported Event|Treatment|Single arm study, 52 mg levonorgestrel (Mirena) intrauterine device
11376463|NCT00799266|BG000|Baseline|Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11376464|NCT00799266|BG001|Baseline|Placebo|Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
11376465|NCT00799266|BG002|Baseline|Total|Total of all reporting groups
11376466|NCT00799266|FG000|Participant Flow|Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11376467|NCT00799266|FG001|Participant Flow|Placebo|Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
11376468|NCT00799266|OG000|Outcome|Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11376469|NCT00799266|OG001|Outcome|Placebo|Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
11376470|NCT00799266|EG000|Reported Event|Zoledronic Acid|Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
11376471|NCT00799266|EG001|Reported Event|Placebo|Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
11376472|NCT00810446|BG000|Baseline|MYCOBUTIN Capsules (Rifabutin)|Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
11376473|NCT00810446|FG000|Participant Flow|MYCOBUTIN Capsules (Rifabutin)|Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
11376474|NCT00810446|OG000|Outcome|MYCOBUTIN Capsules (Rifabutin)|Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
11376475|NCT00810446|EG000|Reported Event|MYCOBUTIN Capsules (Rifabutin)|Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
11376476|NCT00844480|BG000|Baseline|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
11376477|NCT00844480|BG001|Baseline|Placebo|placebo: iv
11376478|NCT00844480|BG002|Baseline|Total|Total of all reporting groups
11376479|NCT00844480|FG000|Participant Flow|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
11376480|NCT00844480|FG001|Participant Flow|Placebo|placebo: iv
11376481|NCT00844480|OG000|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
11376482|NCT00844480|OG001|Outcome|Placebo|placebo: iv
11376483|NCT00844480|EG000|Reported Event|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
11376484|NCT00844480|EG001|Reported Event|Placebo|placebo: iv
11376485|NCT00864474|BG000|Baseline|Celsentri (Maraviroc) Tablets|"HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food. The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018."
11372396|NCT00436826|BG000|Baseline|Cladribine 3.5 mg/kg, IFN-beta|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
11372397|NCT00436826|BG001|Baseline|Placebo, IFN-beta|Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
11372398|NCT00436826|BG002|Baseline|Total|Total of all reporting groups
11372399|NCT00436826|FG000|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks.
11372400|NCT00436826|FG001|Participant Flow|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
11372401|NCT00436826|FG002|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372402|NCT00436826|FG003|Participant Flow|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372403|NCT00436826|FG004|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372404|NCT00436826|FG005|Participant Flow|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372405|NCT00436826|OG000|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks.
11372406|NCT00436826|OG001|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
11372407|NCT00436826|OG002|Outcome|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372408|NCT00436826|OG003|Outcome|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372409|NCT00436826|OG000|Outcome|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372410|NCT00436826|OG001|Outcome|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372411|NCT00436826|OG002|Outcome|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372412|NCT00436826|OG003|Outcome|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372413|NCT00436826|EG000|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks.
11372414|NCT00436826|EG001|Reported Event|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
11372415|NCT00436826|EG002|Reported Event|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372416|NCT00436826|EG003|Reported Event|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372417|NCT00436826|EG004|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11372418|NCT00436826|EG005|Reported Event|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
11376486|NCT00864474|FG000|Participant Flow|Celsentri (Maraviroc) Tablets|"Human immunodeficiency virus (HIV) infected participants, prescribed with Celsentri tablet 150 milligram (mg) depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food. The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018."
11376487|NCT00864474|OG000|Outcome|Celsentri (Maraviroc) Tablets|"HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food. The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018."
11376488|NCT00864474|EG000|Reported Event|Celsentri (Maraviroc) Tablets|"HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food. The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018."
10850092|NCT00300274|BG002|Baseline|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
11372419|NCT00442546|BG000|Baseline|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372420|NCT00442546|BG001|Baseline|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372421|NCT00442546|BG002|Baseline|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
11372422|NCT00442546|BG003|Baseline|Total|Total of all reporting groups
11372423|NCT00442546|FG000|Participant Flow|Pregabalin (150 Milligrams [mg])|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
11372424|NCT00442546|FG001|Participant Flow|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372425|NCT00442546|FG002|Participant Flow|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
11372426|NCT00442546|OG000|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372427|NCT00442546|OG001|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372428|NCT00442546|OG002|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
11372429|NCT00442546|OG001|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
11372430|NCT00442546|OG000|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372431|NCT00442546|EG000|Reported Event|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
10850093|NCT00300274|BG003|Baseline|Total|Total of all reporting groups
11372432|NCT00442546|EG001|Reported Event|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
11372433|NCT00442546|EG002|Reported Event|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
11372434|NCT04715932|BG000|Baseline|Hesperidin 1000mg|Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372435|NCT04715932|BG001|Baseline|Placebo 1000mg|Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372436|NCT04715932|BG002|Baseline|Total|Total of all reporting groups
11372437|NCT04715932|FG000|Participant Flow|Hesperidin 1000mg|Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372438|NCT04715932|FG001|Participant Flow|Placebo 1000mg|Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372439|NCT04715932|OG000|Outcome|Hesperidin 1000mg|Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372440|NCT04715932|OG001|Outcome|Placebo 1000mg|Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372441|NCT04715932|EG000|Reported Event|Hesperidin 1000mg|Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372442|NCT04715932|EG001|Reported Event|Placebo 1000mg|Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
11372443|NCT04666441|BG000|Baseline|Placebo IV Dose|Participants received a single intravenous dose of placebo matching REGN10933+REGN10987
11372444|NCT04666441|BG001|Baseline|300mg IV|Participants received a single 300mg intravenous dose of REGN10933+REGN10987
11372445|NCT04666441|BG002|Baseline|600mg IV|Participants received a single 600mg intravenous dose of REGN10933+REGN10987
11372446|NCT04666441|BG003|Baseline|1200mg IV|Participants received a single 1200mg intravenous dose of REGN10933+REGN10987
11372447|NCT04666441|BG004|Baseline|2400mg IV|Participants received a single 2400mg intravenous dose of REGN10933+REGN10987
11372448|NCT04666441|BG005|Baseline|Placebo SC Dose|Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987
11372449|NCT04666441|BG006|Baseline|600mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372450|NCT04666441|BG007|Baseline|1200mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11372451|NCT04666441|BG008|Baseline|Total|Total of all reporting groups
11372452|NCT04666441|FG000|Participant Flow|Placebo IV Dose|Participants received a single intravenous dose of placebo matching REGN10933+REGN10987
11372453|NCT04666441|FG001|Participant Flow|300mg IV|Participants received a single 300mg intravenous dose of REGN10933+REGN10987
11372454|NCT04666441|FG002|Participant Flow|600mg IV|Participants received a single 600mg intravenous dose of REGN10933+REGN10987
11372455|NCT04666441|FG003|Participant Flow|1200mg IV|Participants received a single 1200mg intravenous dose of REGN10933+REGN10987
11372456|NCT04666441|FG004|Participant Flow|2400mg IV|Participants received a single 2400mg intravenous dose of REGN10933+REGN10987
11372457|NCT04666441|FG005|Participant Flow|Placebo SC Dose|Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987
11372458|NCT04666441|FG006|Participant Flow|600mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372459|NCT04666441|FG007|Participant Flow|1200mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11372460|NCT04666441|OG000|Outcome|Pooled Placebo (IV + SC)|Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987
11372461|NCT04666441|OG001|Outcome|300mg IV|Participants received a single 300mg intravenous dose of REGN10933+REGN10987
11372462|NCT04666441|OG002|Outcome|600mg IV|Participants received a single 600mg intravenous dose of REGN10933+REGN10987
11372463|NCT04666441|OG003|Outcome|1200mg IV|Participants received a single 1200mg intravenous dose of REGN10933+REGN10987
11372464|NCT04666441|OG004|Outcome|2400mg IV|Participants received a single 2400mg intravenous dose of REGN10933+REGN10987
11372465|NCT04666441|OG005|Outcome|600mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372466|NCT04666441|OG006|Outcome|1200mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11372467|NCT04666441|OG000|Outcome|Placebo IV Dose|Participants received a single intravenous dose of placebo matching REGN10933+REGN10987
11372468|NCT04666441|OG005|Outcome|Placebo SC Dose|Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987
11372469|NCT04666441|OG006|Outcome|600mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372470|NCT04666441|OG007|Outcome|1200mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11372471|NCT04666441|OG000|Outcome|300mg IV|Participants received a single 300mg intravenous dose of REGN10933+REGN10987
11372472|NCT04666441|OG001|Outcome|600mg IV|Participants received a single 600mg intravenous dose of REGN10933+REGN10987
11372473|NCT04666441|OG002|Outcome|1200mg IV|Participants received a single 1200mg intravenous dose of REGN10933+REGN10987
11372474|NCT04666441|OG003|Outcome|2400mg IV|Participants received a single 2400mg intravenous dose of REGN10933+REGN10987
11372475|NCT04666441|OG004|Outcome|600mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372476|NCT04666441|OG005|Outcome|1200mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11372477|NCT04666441|EG000|Reported Event|Placebo IV|Participants received a single intravenous dose of placebo matching REGN10933+REGN10987
11372478|NCT04666441|EG001|Reported Event|REGN10933 + REGN10987 300 mg IV|Participants received a single 300mg intravenous dose of REGN10933+REGN10987
11372479|NCT04666441|EG002|Reported Event|REGN10933 + REGN10987 600 mg IV|Participants received a single 600mg intravenous dose of REGN10933+REGN10987
11372480|NCT04666441|EG003|Reported Event|REGN10933 + REGN10987 1200 mg IV|Participants received a single 1200mg intravenous dose of REGN10933+REGN10987
11372481|NCT04666441|EG004|Reported Event|REGN10933 + REGN10987 2400 mg IV|Participants received a single 2400mg intravenous dose of REGN10933+REGN10987
11372482|NCT04666441|EG005|Reported Event|Placebo SC|Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987
11372483|NCT04666441|EG006|Reported Event|REGN10933 + REGN10987 600 mg SC|Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987
11372484|NCT04666441|EG007|Reported Event|REGN10933 + REGN10987 1200 mg SC|Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
11376489|NCT00873366|BG000|Baseline|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
11376490|NCT00873366|FG000|Participant Flow|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
11376491|NCT00873366|OG000|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
11376492|NCT00873366|EG000|Reported Event|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
11376493|NCT00923247|BG000|Baseline|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11372485|NCT04593641|BG000|Baseline|CT-P59 20 mg/kg|Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
11372486|NCT04593641|BG001|Baseline|CT-P59 40 mg/kg|Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
11372487|NCT04593641|BG002|Baseline|CT-P59 80 mg/kg|Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
11372488|NCT04593641|BG003|Baseline|Placebo|Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
11372489|NCT04593641|BG004|Baseline|Total|Total of all reporting groups
11372490|NCT04593641|FG000|Participant Flow|CT-P59 20 mg/kg|Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
11372491|NCT04593641|FG001|Participant Flow|CT-P59 40 mg/kg|Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
11372492|NCT04593641|FG002|Participant Flow|CT-P59 80 mg/kg|Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
11372493|NCT04593641|FG003|Participant Flow|Placebo|Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
11372494|NCT04593641|OG000|Outcome|CT-P59 20 mg/kg|Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
11372495|NCT04593641|OG001|Outcome|CT-P59 40 mg/kg|Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
11372496|NCT04593641|OG002|Outcome|CT-P59 80 mg/kg|Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
11372497|NCT04593641|OG003|Outcome|Placebo|Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
11372498|NCT04593641|EG000|Reported Event|CT-P59 20 mg/kg|Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
11372499|NCT04593641|EG001|Reported Event|CT-P59 40 mg/kg|Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
11372500|NCT04593641|EG002|Reported Event|CT-P59 80 mg/kg|Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
11372501|NCT04593641|EG003|Reported Event|Placebo|Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
11372502|NCT04381052|BG000|Baseline|Clazakizumab 25 mg|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.~Clazakizumab: Dose is 25mg intravenously over 30 minutes."
11372503|NCT04381052|BG001|Baseline|Placebo|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.~Placebo: Intravenously administered over 30 minutes."
11372504|NCT04381052|BG002|Baseline|Total|Total of all reporting groups
11372505|NCT04381052|FG000|Participant Flow|Clazakizumab 25 mg or Placebo|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into a specific arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following first dose administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.~Placebo: Intravenously administered over 30 minutes. OR Clazakizumab: Dose is 25mg intravenously over 30 minutes."
11372506|NCT04381052|OG000|Outcome|Clazakizumab 25 mg|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.~Clazakizumab: Dose is 25mg intravenously over 30 minutes."
11372507|NCT04381052|OG001|Outcome|Placebo|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.~Placebo: Intravenously administered over 30 minutes."
11372508|NCT04381052|EG000|Reported Event|Clazakizumab 25 mg|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.~Clazakizumab: Dose is 25mg intravenously over 30 minutes."
11372509|NCT04381052|EG001|Reported Event|Placebo|"The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.~Placebo: Intravenously administered over 30 minutes."
11372510|NCT04259346|BG000|Baseline|80 mg Ixekizumab (Reference)|Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
11372511|NCT04259346|BG001|Baseline|80 mg Ixekizumab (Test)|Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
11372512|NCT04259346|BG002|Baseline|Total|Total of all reporting groups
11372513|NCT04259346|FG000|Participant Flow|80 Milligram (mg) Ixekizumab (Reference)|Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a subcutaneous (SC) injection via autoinjector (AI).
11372514|NCT04259346|FG001|Participant Flow|80 mg Ixekizumab (Test)|Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
11372515|NCT04259346|OG000|Outcome|80 mg Ixekizumab (Reference)|Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
11372516|NCT04259346|OG001|Outcome|80 mg Ixekizumab (Test)|Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
11372517|NCT04259346|EG000|Reported Event|80 mg Ixekizumab (Reference)|Participants received 80 mg ixekizumab of approved commercial formulation (Reference) administered as a SC injection via AI.
11372518|NCT04259346|EG001|Reported Event|80 mg Ixekizumab (Test)|Participants received 80 mg ixekizumab alternate formulation (Test) administered as a SC injection via AI.
11376494|NCT00923247|BG001|Baseline|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376495|NCT00923247|BG002|Baseline|Total|Total of all reporting groups
11376496|NCT00923247|FG000|Participant Flow|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376497|NCT00923247|FG001|Participant Flow|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376498|NCT00923247|OG000|Outcome|Phase 1|"Patients will be treated with vandetanib to find the maximally tolerated dose.~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib on days 1, 4, 8 & 11 every 28 days in adults"
11376499|NCT00923247|OG000|Outcome|Phase 1|"Patients will be treated with bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376500|NCT00923247|OG000|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376501|NCT00923247|OG000|Outcome|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376502|NCT00923247|OG000|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376503|NCT00923247|OG001|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376504|NCT00923247|OG001|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11190313|NCT02124772|FG007|Participant Flow|Part B - BRAF V600 Mutant Solid Tumor|Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
11190314|NCT02124772|FG008|Participant Flow|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11372519|NCT03959423|BG000|Baseline|Subjects 7-17 Years of Age|Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372520|NCT03959423|BG001|Baseline|Subjects 18-75 Years of Age|Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372521|NCT03959423|BG002|Baseline|Total|Total of all reporting groups
11372522|NCT03959423|FG000|Participant Flow|Subjects 7-17 Years of Age|Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372523|NCT03959423|FG001|Participant Flow|Subjects 18-75 Years of Age|Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372524|NCT03959423|OG000|Outcome|Subjects 7-17 Years of Age|Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372525|NCT03959423|OG001|Outcome|Subjects 18-75 Years of Age|Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372526|NCT03959423|EG000|Reported Event|Subjects 7-17 Years of Age|Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372527|NCT03959423|EG001|Reported Event|Subjects 18-75 Years of Age|Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
11372528|NCT03713320|BG000|Baseline|Cobomarsen|Cobomarsen: At least weekly doses of cobomarsen (282 mg) throughout study treatment period
11372529|NCT03713320|BG001|Baseline|Vorinostat|Vorinostat: Daily doses of vorinostat throughout study treatment period
11372530|NCT03713320|BG002|Baseline|Total|Total of all reporting groups
11372531|NCT03713320|FG000|Participant Flow|Cobomarsen (Randomized)|Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion
11372532|NCT03713320|FG001|Participant Flow|Vorinostat (Randomized)|"Vorinostat (400 mg [4x100 mg capsules]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (> upper limit of normal [ULN]) or bilirubin (> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.~Vorinostat: 100 mg capsules"
11372533|NCT03713320|FG002|Participant Flow|Cobomarsen (Crossover)|For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion
11372534|NCT03713320|OG000|Outcome|Cobomarsen (Randomized)|Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion
11190315|NCT02124772|FG009|Participant Flow|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190316|NCT02124772|FG010|Participant Flow|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11190317|NCT02124772|FG011|Participant Flow|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190318|NCT02124772|FG012|Participant Flow|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190319|NCT02124772|OG000|Outcome|Part A - TMT 0.0125 mg/kg/Day|Participants treated with trametinib 0.0125 mg/kg/day
11372535|NCT03713320|OG001|Outcome|Vorinostat (Randomized)|"Vorinostat (400 mg [4x100 mg capsules]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (> upper limit of normal [ULN]) or bilirubin (> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.~Vorinostat: 100 mg capsules"
11372536|NCT03713320|EG000|Reported Event|Cobomarsen (Randomized)|Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion
11372537|NCT03713320|EG001|Reported Event|Vorinostat (Randomized)|"Vorinostat (400 mg [4x100 mg capsules]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (> upper limit of normal [ULN]) or bilirubin (> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.~Vorinostat: 100 mg capsules"
11372538|NCT03713320|EG002|Reported Event|Cobomarsen (Crossover)|For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion
11372539|NCT03429049|BG000|Baseline|Placebo|Matching placebo of 2.0 mL for IA injection
11372540|NCT03429049|BG001|Baseline|CNTX-4975-05|Pre-filled glass syringes administered as a single 2.0 mL IA injection
11372541|NCT03429049|BG002|Baseline|Total|Total of all reporting groups
11372542|NCT03429049|FG000|Participant Flow|Placebo|Matching placebo of 2.0 mL for IA injection
11372543|NCT03429049|FG001|Participant Flow|CNTX-4975-05|Pre-filled glass syringes administered as a single 2.0 mL IA injection
11372544|NCT03429049|OG000|Outcome|Placebo|Matching placebo of 2.0 mL for IA injection
11372545|NCT03429049|OG001|Outcome|CNTX-4975-05|Pre-filled glass syringes administered as a single 2.0 mL IA injection
11372546|NCT03429049|EG000|Reported Event|Placebo|Matching placebo of 2.0 mL for IA injection
11372547|NCT03429049|EG001|Reported Event|CNTX-4975-05|Pre-filled glass syringes administered as a single 2.0 mL IA injection
11372548|NCT03409731|BG000|Baseline|Absorb GT1 BVS|Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
11372549|NCT03409731|FG000|Participant Flow|Absorb GT1 BVS|Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
11372550|NCT03409731|OG000|Outcome|Absorb GT1 BVS|Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
11372551|NCT03409731|EG000|Reported Event|Absorb GT1 BVS|Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
11376505|NCT00923247|OG000|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376506|NCT00923247|EG000|Reported Event|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11376507|NCT00923247|EG001|Reported Event|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
11377159|NCT03853291|BG003|Baseline|Healthcare Providers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377160|NCT03853291|BG004|Baseline|Family Caregivers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377161|NCT03853291|BG005|Baseline|Healthcare Providers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377162|NCT03853291|BG006|Baseline|Total|Total of all reporting groups
11377163|NCT03853291|FG000|Participant Flow|PICT Workbook|PICT Workbook: The PICT workbook is a 31 page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
11377164|NCT03853291|FG001|Participant Flow|Information Pamphlet|"Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.~Information Pamphlet: Pamphlet with information about pain and dementia and links to Alzheimer's Association"
11372552|NCT03283566|BG000|Baseline|Hydroxychloroquine|"Administered pre-transplant through 3 months after surgery.~Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery."
11372553|NCT03283566|BG001|Baseline|Placebo|"Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).~Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery."
11372554|NCT03283566|BG002|Baseline|Total|Total of all reporting groups
11372555|NCT03283566|FG000|Participant Flow|Hydroxychloroquine|"Administered pre-transplant through 3 months after surgery.~Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery."
11372556|NCT03283566|FG001|Participant Flow|Placebo|"Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).~Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery."
11372557|NCT03283566|OG000|Outcome|Hydroxychloroquine|"Administered pre-transplant through 3 months after surgery.~Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery."
11372558|NCT03283566|OG001|Outcome|Placebo|"Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).~Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery."
11372559|NCT03283566|EG000|Reported Event|Hydroxychloroquine|"Administered pre-transplant through 3 months after surgery.~Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery."
11372560|NCT03283566|EG001|Reported Event|Placebo|"Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).~Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery."
11372561|NCT03077412|BG000|Baseline|Filgotinib 200 mg|Participants received filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
11372562|NCT03077412|BG001|Baseline|Filgotinib 100 mg|Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for 24 weeks.
11372563|NCT03077412|BG002|Baseline|Placebo|Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
11372564|NCT03077412|BG003|Baseline|Total|Total of all reporting groups
11372565|NCT03077412|FG000|Participant Flow|Filgotinib 200 mg|Participants received filgotinib 200 milligrams (mg) and placebo to match (PTM) filgotinib 100 mg, once daily for 24 weeks.
11372566|NCT03077412|FG001|Participant Flow|Filgotinib 100 mg|Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for 24 weeks.
11372567|NCT03077412|FG002|Participant Flow|Placebo|Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
11372568|NCT03077412|OG000|Outcome|Filgotinib 200 mg|Participants received filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
11372569|NCT03077412|OG001|Outcome|Filgotinib 100 mg|Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for 24 weeks.
11372570|NCT03077412|OG002|Outcome|Placebo|Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for 24 weeks.
11372571|NCT03077412|EG000|Reported Event|Filgotinib 200 mg|Participants received filgotinib 200 mg and PTM filgotinib 100 mg, once daily for up to Week 26.
11372572|NCT03077412|EG001|Reported Event|Filgotinib 100 mg|Participants received filgotinib 100 mg and PTM filgotinib 200 mg, once daily for up to Week 29.3.
11372573|NCT03077412|EG002|Reported Event|Placebo|Participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily for up to Week 27.9.
11372574|NCT03026504|BG000|Baseline|Baricitinib Therapy|"4 milligrams oral Baricitinib daily for 52 weeks~Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks"
11372575|NCT03026504|FG000|Participant Flow|Single Arm|All participants assigned to baricitinib 4 mg daily orally for 52 weeks.
11372576|NCT03026504|OG000|Outcome|Baricitinib Therapy|"4 milligrams oral Baricitinib daily for 52 weeks~Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks"
11372577|NCT03026504|EG000|Reported Event|Baricitinib Therapy|"4 milligrams oral Baricitinib daily for 52 weeks~Baricitinib: 4 milligrams oral Baricitinib daily for 52 weeks"
11372578|NCT02971956|BG000|Baseline|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
11372579|NCT02971956|FG000|Participant Flow|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
11372580|NCT02971956|OG000|Outcome|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
11372581|NCT02971956|EG000|Reported Event|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
11372582|NCT02915367|BG000|Baseline|SMS Reminders|"Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.~SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill)."
11372583|NCT02915367|BG001|Baseline|No Reminders|Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
11372584|NCT02915367|BG002|Baseline|Total|Total of all reporting groups
11372585|NCT02915367|FG000|Participant Flow|SMS Reminders|"Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.~SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill)."
11372586|NCT02915367|FG001|Participant Flow|No Reminders|Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
11376508|NCT00928226|BG000|Baseline|Arm 1 - 24 Grey SRS|"24 Grey administered as 8 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11372587|NCT02915367|OG000|Outcome|SMS Reminders|"Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.~SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill)."
11372588|NCT02915367|OG001|Outcome|No Reminders|Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
11372589|NCT02915367|EG000|Reported Event|SMS Reminders|"Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.~SMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill)."
11372590|NCT02915367|EG001|Reported Event|No Reminders|Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
11372591|NCT02665143|BG000|Baseline|Nintedanib and AML Induction|"The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .~Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid)."
11372592|NCT02665143|FG000|Participant Flow|Nintedanib and AML Induction|"The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .~Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid)."
11372593|NCT02665143|OG000|Outcome|Nintedanib and AML Induction|"The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .~Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid)."
11372594|NCT02665143|EG000|Reported Event|Nintedanib and AML Induction: Phase 1|"The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .~Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid)."
11372595|NCT02665143|EG001|Reported Event|Nintedanib and AML Induction: Phase 2|"The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .~Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid)."
11372596|NCT02550470|BG000|Baseline|Randomized to Micropore SpiraLith|"lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8~Micropore SpiraLith: lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.~Sevoflurane"
11372597|NCT02550470|BG001|Baseline|Randomized to Drager 800 Absorbent|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11190320|NCT02124772|OG001|Outcome|Part A - TMT 0.025 mg/kg/Day|Participants treated with trametinib 0.025 mg/kg/day
11190321|NCT02124772|OG002|Outcome|Part A - TMT 0.032 mg/kg/Day|Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
11376509|NCT00928226|BG001|Baseline|Arm 2 - 27 Grey SRS|"27 Grey administered as 9 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11190322|NCT02124772|OG003|Outcome|Part A - TMT 0.04 mg/kg/Day|Participants treated with trametinib 0.04 mg/kg/day
11190323|NCT02124772|OG004|Outcome|Part B - Neuroblastoma|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190324|NCT02124772|OG005|Outcome|Part B - LGG Fusion|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190325|NCT02124772|OG006|Outcome|Part B - NF-1 With PN|Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
11190326|NCT02124772|OG007|Outcome|Part B - BRAF V600 Mutant Solid Tumor|Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
11190327|NCT02124772|OG008|Outcome|Part B - All Tumor Types TMT 0.025 mg/kg/Day|Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day
11190328|NCT02124772|OG005|Outcome|Part B - LGG Fusion|Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day
11190329|NCT02124772|OG009|Outcome|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11190330|NCT02124772|OG010|Outcome|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190331|NCT02124772|OG011|Outcome|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11190332|NCT02124772|OG012|Outcome|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190333|NCT02124772|OG013|Outcome|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190334|NCT02124772|OG014|Outcome|Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
10962822|NCT00868608|OG000|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11190335|NCT02124772|OG015|Outcome|Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190336|NCT02124772|OG000|Outcome|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11190337|NCT02124772|OG001|Outcome|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190338|NCT02124772|OG002|Outcome|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11190339|NCT02124772|OG003|Outcome|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190340|NCT02124772|OG004|Outcome|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190341|NCT02124772|OG005|Outcome|Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11240459|NCT02479412|FG003|Participant Flow|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
10849899|NCT00299130|OG001|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11190342|NCT02124772|OG006|Outcome|Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11376510|NCT00928226|BG002|Baseline|Arm 3 - 30 Grey SRS|"30 Grey administered as 10 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376511|NCT00928226|BG003|Baseline|Arm 4 - 33 Grey SRS|"33 Grey administered as 11 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376512|NCT00928226|BG004|Baseline|Total|Total of all reporting groups
11376513|NCT00928226|FG000|Participant Flow|Arm 1 - 24 Grey SRS|"24 Grey administered as 8 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376514|NCT00928226|FG001|Participant Flow|Arm 2 - 27 Grey SRS|"27 Grey administered as 9 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376515|NCT00928226|FG002|Participant Flow|Arm 3 - 30 Grey SRS|"30 Grey administered as 10 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376516|NCT00928226|FG003|Participant Flow|Arm 4 - 33 Grey SRS|"33 Grey administered as 11 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376517|NCT00928226|OG000|Outcome|Arm 1 - 24 Grey SRS|"24 Grey administered as 8 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376518|NCT00928226|OG001|Outcome|Arm 2 - 27 Grey SRS|"27 Grey administered as 9 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376519|NCT00928226|OG002|Outcome|Arm 3 - 30 Grey SRS|"30 Grey administered as 10 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376520|NCT00928226|OG003|Outcome|Arm 4 - 33 Grey SRS|"33 Grey administered as 11 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11372598|NCT02550470|BG002|Baseline|Randomized to Drager Free|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372599|NCT02550470|BG003|Baseline|Total|Total of all reporting groups
11372600|NCT02550470|FG000|Participant Flow|Randomized to Micropore SpiraLith|"lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8~Micropore SpiraLith: lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.~Sevoflurane"
11372601|NCT02550470|FG001|Participant Flow|Randomized to Drager 800 Absorbent|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372602|NCT02550470|FG002|Participant Flow|Randomized to Drager Free|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372603|NCT02550470|OG000|Outcome|Randomized to Micropore SpiraLith|"lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8~Micropore SpiraLith: lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.~Sevoflurane"
11372604|NCT02550470|OG001|Outcome|Randomized to Drager 800 Absorbent|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11376521|NCT00928226|EG000|Reported Event|Arm 1 - 24 Grey SRS|"24 Grey administered as 8 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376522|NCT00928226|EG001|Reported Event|Arm 2 - 27 Grey SRS|"27 Grey administered as 9 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376523|NCT00928226|EG002|Reported Event|Arm 3 - 30 Grey SRS|"30 Grey administered as 10 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11376524|NCT00928226|EG003|Reported Event|Arm 4 - 33 Grey SRS|"33 Grey administered as 11 Gy x 3 fractions~Fractionated Stereotactic Radiosurgery (SRS): Standard of care~Surgical resection: Standard of care"
11190343|NCT02124772|OG008|Outcome|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11190344|NCT02124772|OG009|Outcome|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190345|NCT02124772|OG010|Outcome|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11190346|NCT02124772|OG011|Outcome|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190347|NCT02124772|OG012|Outcome|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190348|NCT02124772|OG000|Outcome|Part A, B, C and D - All Participants With PK Data|Participants in the study (all doses and all tumor types) with available pharmacokinetic data
11190349|NCT02124772|OG000|Outcome|TMT 0.0125 mg/kg/Day|Participants treated with trametinib oral solution at a dose level of 0.0125 mg/kg/day
11190350|NCT02124772|OG001|Outcome|TMT 0.025 mg/kg/Day|Participants treated with trametinib oral solution at a dose level of 0.025 mg/kg/day
11190351|NCT02124772|OG002|Outcome|TMT 0.032 mg/kg/Day|Participants treated with trametinib oral solution at a dose level of 0.032 mg/kg/day
11190352|NCT02124772|OG003|Outcome|TMT 0.04 mg/kg/Day|Participants treated with trametinib oral solution at a dose level of 0.04 mg/kg/day
11190353|NCT02124772|OG000|Outcome|TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
11376525|NCT00930722|BG000|Baseline|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
11190354|NCT02124772|OG001|Outcome|TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
11372605|NCT02550470|OG002|Outcome|Randomized to Drager Free|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372606|NCT02550470|EG000|Reported Event|Randomized to Micropore SpiraLith|"lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8~Micropore SpiraLith: lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.~Sevoflurane"
11372607|NCT02550470|EG001|Reported Event|Randomized to Drager 800 Absorbent|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372608|NCT02550470|EG002|Reported Event|Randomized to Drager Free|"Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Carbon Dioxide Absorbents: Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.~Sevoflurane"
11372609|NCT02384850|BG000|Baseline|Selinexor 40mg + mFOLFOX6|"Selinexor: Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372610|NCT02384850|BG001|Baseline|Selinexor 20mg + mFOLFOX6|"Selinexor: Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372611|NCT02384850|BG002|Baseline|Total|Total of all reporting groups
11372612|NCT02384850|FG000|Participant Flow|Selinexor 40 mg+ mFOLFOX6|"Selinexor: Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372613|NCT02384850|FG001|Participant Flow|Selinexor 20mg + mFOLFOX6|"Selinexor: Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372614|NCT02384850|OG000|Outcome|Selinexor 40 mg+ mFOLFOX6|"Selinexor: Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372615|NCT02384850|OG001|Outcome|Selinexor 20mg + mFOLFOX6|"Selinexor: Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11190355|NCT02124772|OG002|Outcome|TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.032 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
11372616|NCT02384850|EG000|Reported Event|Selinexor 40mg + mFOLFOX6|"Selinexor: Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372617|NCT02384850|EG001|Reported Event|Selinexor 20mg + mFOLFOX6|"Selinexor: Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.~Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle~5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3~Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle"
11372618|NCT02352090|BG000|Baseline|Synthetic Estrogen + Progestin|"Ethinyl estradiol / dienogest~Ethinyl estradiol / dienogest: One tablet orally for 9 weeks, continuous use"
11372619|NCT02352090|BG001|Baseline|Natural Estrogen + Progestin|"Estradiol valerate / dienogest~Estradiol valerate / dienogest: One tablet orally for 9 weeks, continuous use"
11372620|NCT02352090|BG002|Baseline|Progestin-Only|"Dienogest~Dienogest: One tablet orally for 9 weeks, continuous use"
11372621|NCT02352090|BG003|Baseline|Total|Total of all reporting groups
11372622|NCT02352090|FG000|Participant Flow|Synthetic Estrogen + Progestin|"Ethinyl estradiol / dienogest~Ethinyl estradiol / dienogest: One tablet orally for 9 weeks, continuous use"
11372623|NCT02352090|FG001|Participant Flow|Natural Estrogen + Progestin|"Estradiol valerate / dienogest~Estradiol valerate / dienogest: One tablet orally for 9 weeks, continuous use"
11372624|NCT02352090|FG002|Participant Flow|Progestin-Only|"Dienogest~Dienogest: One tablet orally for 9 weeks, continuous use"
11190356|NCT02124772|EG000|Reported Event|Part A - TMT 0.0125 mg/kg/Day|Participants treated with trametinib 0.0125 mg/kg/day
11372625|NCT02352090|OG000|Outcome|Synthetic Estrogen + Progestin|"Ethinyl estradiol / dienogest~Ethinyl estradiol / dienogest: One tablet orally for 9 weeks, continuous use"
11372626|NCT02352090|OG001|Outcome|Natural Estrogen + Progestin|"Estradiol valerate / dienogest~Estradiol valerate / dienogest: One tablet orally for 9 weeks, continuous use"
10962823|NCT00868608|OG000|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles (in participants who achieved a CR). After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11190357|NCT02124772|EG001|Reported Event|Part A - TMT 0.025 mg/kg/Day|Participants treated with trametinib 0.025 mg/kg/day
11190358|NCT02124772|EG002|Reported Event|Part A - TMT 0.032 mg/kg/Day|Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
11372627|NCT02352090|OG002|Outcome|Progestin-Only|"Dienogest~Dienogest: One tablet orally for 9 weeks, continuous use"
11372628|NCT02352090|EG000|Reported Event|Synthetic Estrogen + Progestin|"Ethinyl estradiol / dienogest~Ethinyl estradiol / dienogest: One tablet orally for 9 weeks, continuous use"
11372629|NCT02352090|EG001|Reported Event|Natural Estrogen + Progestin|"Estradiol valerate / dienogest~Estradiol valerate / dienogest: One tablet orally for 9 weeks, continuous use"
11372630|NCT02352090|EG002|Reported Event|Progestin-Only|"Dienogest~Dienogest: One tablet orally for 9 weeks, continuous use"
11372631|NCT01976091|BG000|Baseline|Cohort 1A: SRP-9004|SRP-9004 was administered once by ILI to a single limb on Day 0. The administered dose was 1*10^12 vector genomes per kilogram bodyweight (vg/kg). Dose determined via supercoiled titer method.
11372632|NCT01976091|BG001|Baseline|Cohort 1B: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 2*10^12 vg/kg split between the two extremities (1*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372633|NCT01976091|BG002|Baseline|Cohort 2: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 6*10^12 vg/kg split between the two extremities (3*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372634|NCT01976091|BG003|Baseline|Total|Total of all reporting groups
11372635|NCT01976091|FG000|Participant Flow|Cohort 1A: SRP-9004|SRP-9004 was administered once by Isolated Limb Infusion (ILI) to a single limb on Day 0. The administered dose was 1*10^12 vector genomes per kilogram bodyweight (vg/kg). Dose determined via supercoiled titer method.
11372636|NCT01976091|FG001|Participant Flow|Cohort 1B: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 2*10^12 vg/kg split between the two extremities (1*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372637|NCT01976091|FG002|Participant Flow|Cohort 2: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 6*10^12 vg/kg split between the two extremities (3*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372638|NCT01976091|OG000|Outcome|Cohort 1A: SRP-9004|SRP-9004 was administered once by ILI to a single limb on Day 0. The administered dose was 1*10^12 vector genomes per kilogram bodyweight (vg/kg). Dose determined via supercoiled titer method.
11372639|NCT01976091|OG001|Outcome|Cohort 1B: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 2*10^12 vg/kg split between the two extremities (1*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372640|NCT01976091|OG002|Outcome|Cohort 2: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 6*10^12 vg/kg split between the two extremities (3*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11372641|NCT01976091|EG000|Reported Event|Cohort 1A: SRP-9004|SRP-9004 was administered once by ILI to a single limb on Day 0. The administered dose was 1*10^12 vector genomes per kilogram bodyweight (vg/kg). Dose determined via supercoiled titer method.
11372642|NCT01976091|EG001|Reported Event|Cohort 1B: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 2*10^12 vg/kg split between the two extremities (1*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
10962824|NCT00868608|EG000|Reported Event|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
11190359|NCT02124772|EG003|Reported Event|Part A - TMT 0.04 mg/kg/Day|Participants treated with trametinib 0.04 mg/kg/day
11190360|NCT02124772|EG004|Reported Event|Part B - Neuroblastoma|Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
11190361|NCT02124772|EG005|Reported Event|Part B - LGG Fusion|Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day
11372643|NCT01976091|EG002|Reported Event|Cohort 2: SRP-9004|SRP-9004 was administered once by ILI to both limbs on Day 0. The participants received a total dose of 6*10^12 vg/kg split between the two extremities (3*10^12 vg/kg per limb). Dose determined via supercoiled titer method.
11376526|NCT00930722|FG000|Participant Flow|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
11376527|NCT00930722|OG000|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
11376528|NCT00930722|EG000|Reported Event|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
11377165|NCT03853291|FG002|Participant Flow|Family Caregivers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377166|NCT03853291|FG003|Participant Flow|Healthcare Providers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377167|NCT03853291|FG004|Participant Flow|Family Caregivers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377168|NCT03853291|FG005|Participant Flow|Healthcare Providers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377169|NCT03853291|OG000|Outcome|PICT Workbook|PICT Workbook: The PICT workbook is a 31 page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
11377170|NCT03853291|OG001|Outcome|Information Pamphlet|"Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.~Information Pamphlet: Pamphlet with information about pain and dementia and links to Alzheimer's Association"
11377171|NCT03853291|OG001|Outcome|Informational Pamphlet|"Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.~Information Pamphlet: Pamphlet with information about pain and dementia and links to Alzheimer's Association"
11190362|NCT02124772|EG006|Reported Event|Part B - NF-1 With PN|Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
11190363|NCT02124772|EG007|Reported Event|Part B - BRAF V600 Mutant Solid Tumor|Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
11372644|NCT01145209|BG000|Baseline|FO Arm (Fludarabine and Ofatumumab)|Fludadabine and ofatumumab for patients with non-high-risk FISH changes
11372645|NCT01145209|BG001|Baseline|FCO Arm (Fludarabine, Cyclophosphamide, and Ofatumumab)|Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
11372646|NCT01145209|BG002|Baseline|Total|Total of all reporting groups
11372647|NCT01145209|FG000|Participant Flow|FCO Arm (Fludarabine, Cyclosphosphamide, and Ofatumumab)|Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
11372648|NCT01145209|FG001|Participant Flow|FO Arm (Fludarabine and Ofatumumab)|Fludadabine and ofatumumab for patients with non-high-risk FISH changes
11372649|NCT01145209|OG000|Outcome|FO Arm|Fludadabine and ofatumumab for patients with non-high-risk FISH changes
11372650|NCT01145209|OG001|Outcome|FCO Arm|Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
11372651|NCT01145209|EG000|Reported Event|FCO (Fludarabine, Cyclosphosphamide, and Ofatumumab)|Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
11372652|NCT01145209|EG001|Reported Event|FO (Fludarabine and Ofatumumab)|Fludadabine and ofatumumab for patients with non-high-risk FISH changes
11372653|NCT01078662|BG000|Baseline|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
11372654|NCT01078662|BG001|Baseline|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
11372655|NCT01078662|BG002|Baseline|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
11372656|NCT01078662|BG003|Baseline|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
11372657|NCT01078662|BG004|Baseline|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
11372658|NCT01078662|BG005|Baseline|Total|Total of all reporting groups
11372659|NCT01078662|FG000|Participant Flow|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
11372660|NCT01078662|FG001|Participant Flow|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
11372661|NCT01078662|FG002|Participant Flow|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
11372662|NCT01078662|FG003|Participant Flow|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
11372663|NCT01078662|FG004|Participant Flow|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
11372664|NCT01078662|OG000|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
11372665|NCT01078662|OG001|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
11372666|NCT01078662|OG002|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
11372667|NCT01078662|OG003|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
10850094|NCT00300274|FG000|Participant Flow|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
10850095|NCT00300274|FG001|Participant Flow|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
11372668|NCT01078662|OG004|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
11372669|NCT01078662|OG005|Outcome|All Patients|Patients of different cancer types
11372670|NCT01078662|EG000|Reported Event|OLAPARIB|
11372671|NCT00971867|BG000|Baseline|Paclitaxel|Each vial (16.7 mL) contains 100 mg
11372672|NCT00971867|FG000|Participant Flow|Paclitaxel|Each vial (16.7 mL) contains 100 mg
11372673|NCT00971867|OG000|Outcome|Paclitaxel|Each vial (16.7 mL) contains 100 mg
11372674|NCT00971867|EG000|Reported Event|Paclitaxel|Each vial (16.7 mL) contains 100 mg
11372675|NCT00853307|BG000|Baseline|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
11372676|NCT00853307|BG001|Baseline|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
11372677|NCT00853307|BG002|Baseline|Total|Total of all reporting groups
11372678|NCT00853307|FG000|Participant Flow|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
11372679|NCT00853307|FG001|Participant Flow|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
11372680|NCT00853307|OG000|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
11372681|NCT00853307|OG001|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
11372682|NCT00853307|EG000|Reported Event|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
11372683|NCT00853307|EG001|Reported Event|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
11372684|NCT00583804|BG000|Baseline|Implanted Individuals|"Individuals implanted with stimulator/sensor device.~IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes."
11372685|NCT00583804|FG000|Participant Flow|Implanted Individuals|"Individuals implanted with stimulator/sensor device. These individuals were implanted with the IST-12 device. The IST-12 is an implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. The device was implanted in the chest, hand and arm to provide functional grasp and reach.~All participants received the implanted device. During the primary outcome testing, the device was tested with the device on and active and compared with the results when the device was turned off. No blinding of either the subject or evaluator was possible because of the obvious response when the stimulator is on (i.e. the hand opens and closes when the stimulator is on; the hand is paralyzed when the stimulator is off)."
11372686|NCT00583804|OG000|Outcome|Stimulation ON|"Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.~IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes."
11372687|NCT00583804|OG001|Outcome|Stimulation OFF|"Function with stimulation turned off.~IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes."
11372688|NCT00583804|OG000|Outcome|Implanted Individuals|Individuals implanted with stimulator/sensor device. These individuals were implanted with the IST-12 device. The IST-12 is an implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. The device was implanted in the chest, hand and arm to provide functional grasp and reach.
11372689|NCT00583804|EG000|Reported Event|Implanted Individuals|"Individuals implanted with stimulator/sensor device.~IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.~Note that all subjects received the implanted device and used the device in the laboratory and at home throughout the course of the study. Therefore there is only a single Arm for adverse events - all subjects received the intervention and stimulation."
11376529|NCT00940498|BG000|Baseline|Part 1: PF-05212384 10 mg|PF-05212384 10 milligram (mg), intravenous (IV) infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376530|NCT00940498|BG001|Baseline|Part 1: PF-05212384 21 mg|PF-05212384 21 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376531|NCT00940498|BG002|Baseline|Part 1: PF-05212384 43 mg|PF-05212384 43 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376532|NCT00940498|BG003|Baseline|Part 1: PF-05212384 89 mg|PF-05212384 89 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376533|NCT00940498|BG004|Baseline|Part 1 and 2: PF-05212384 154 mg|PF-05212384 154 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) and Part 2 (MTD confirmation) of the study.
11376534|NCT00940498|BG005|Baseline|Part 1: PF-05212384 222 mg|PF-05212384 222 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376535|NCT00940498|BG006|Baseline|Part 1: PF-05212384 266 mg|PF-05212384-266 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376536|NCT00940498|BG007|Baseline|Part 1: PF-05212384 319 mg|PF-05212384-319 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376537|NCT00940498|BG008|Baseline|Total|Total of all reporting groups
11376538|NCT00940498|FG000|Participant Flow|Part 1: PF-05212384 10 mg|PF-05212384 10 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376539|NCT00940498|FG001|Participant Flow|Part 1: PF-05212384 21 mg|PF-05212384 21 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376540|NCT00940498|FG002|Participant Flow|Part 1: PF-05212384 43 mg|PF-05212384 43 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11190364|NCT02124772|EG008|Reported Event|Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for <12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
11372690|NCT00545129|BG000|Baseline|Tanezumab|Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372691|NCT00545129|BG001|Baseline|Placebo|Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372692|NCT00545129|BG002|Baseline|Total|Total of all reporting groups
11372693|NCT00545129|FG000|Participant Flow|Tanezumab|Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372694|NCT00545129|FG001|Participant Flow|Placebo|Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372695|NCT00545129|OG000|Outcome|Tanezumab|Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372696|NCT00545129|OG001|Outcome|Placebo|Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372697|NCT00545129|EG000|Reported Event|Tanezumab|Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11372698|NCT00545129|EG001|Reported Event|Placebo|Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.
11376541|NCT00940498|FG003|Participant Flow|Part 1: PF-05212384 89 mg|PF-05212384 89 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376542|NCT00940498|FG004|Participant Flow|Part 1 and 2: PF-05212384 154 mg|PF-05212384 154 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) and Part 2 (MTD confirmation) of the study.
11376543|NCT00940498|FG005|Participant Flow|Part 1: PF-05212384 222 mg|PF-05212384 222 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376544|NCT00940498|FG006|Participant Flow|Part 1: PF-05212384 266 mg|PF-05212384-266 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376545|NCT00940498|FG007|Participant Flow|Part 1: PF-05212384 319 mg|PF-05212384-319 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376546|NCT00940498|OG000|Outcome|Part 1: PF-05212384 10 mg|PF-05212384 10 milligram (mg), intravenous (IV) infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376547|NCT00940498|OG001|Outcome|Part 1: PF-05212384 21 mg|PF-05212384 21 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376548|NCT00940498|OG002|Outcome|Part 1: PF-05212384 43 mg|PF-05212384 43 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376549|NCT00940498|OG003|Outcome|Part 1: PF-05212384 89 mg|PF-05212384 89 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376550|NCT00940498|OG004|Outcome|Part 1 and 2: PF-05212384 154 mg|PF-05212384 154 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) and Part 2 (MTD confirmation) of the study.
11376551|NCT00940498|OG005|Outcome|Part 1: PF-05212384 222 mg|PF-05212384 222 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376552|NCT00940498|OG006|Outcome|Part 1: PF-05212384 266 mg|PF-05212384-266 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376553|NCT00940498|OG007|Outcome|Part 1: PF-05212384 319 mg|PF-05212384-319 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11190365|NCT02124772|EG009|Reported Event|Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D|Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190366|NCT02124772|EG010|Reported Event|Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D|Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
11190367|NCT02124772|EG011|Reported Event|Part D - LGG|Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190368|NCT02124772|EG012|Reported Event|Part D - LCH|Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for < 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for <12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
11190369|NCT02124798|BG000|Baseline|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
11372699|NCT00548093|BG000|Baseline|PF-00299804 (Adenocarcinoma Histology)|Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372700|NCT00548093|BG001|Baseline|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372701|NCT00548093|BG002|Baseline|Total|Total of all reporting groups
11372702|NCT00548093|FG000|Participant Flow|PF-00299804 (Adenocarcinoma Histology)|Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11190370|NCT02124798|FG000|Participant Flow|Total|Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
11190371|NCT02124798|OG000|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
11190372|NCT02124798|EG000|Reported Event|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
11372703|NCT00548093|FG001|Participant Flow|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372704|NCT00548093|OG000|Outcome|PF-00299804 (Adenocarcinoma Histology)|Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372705|NCT00548093|OG000|Outcome|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372706|NCT00548093|OG001|Outcome|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372707|NCT00548093|OG000|Outcome|PF-00299804 (Adenocarcinoma Histology)|Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days up to 1 year or until unacceptable toxicity, tumor progression, death or investigator's discretion.
11372708|NCT00548093|OG001|Outcome|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days up to 1 year or until unacceptable toxicity, tumor progression, death or investigator's discretion.
11372709|NCT00548093|EG000|Reported Event|PF-00299804 (Adenocarcinoma Histology)|Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11372710|NCT00548093|EG001|Reported Event|PF-00299804 (Non-adenocarcinoma Histology)|Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.
11376554|NCT00940498|OG000|Outcome|PF-05212384 : All Participants|All participants who received PF-05212384 10 mg or 21 mg or 43 mg or 89 mg or 154 mg or 222 mg or 266 mg or 319 mg, intravenous infusion, once weekly in each 28 day cycle until progression of disease, uncontrollable toxicity, or a decision by the participant or investigator to discontinue.
11376555|NCT00940498|OG000|Outcome|Part 1 and 2: PF-05212384 154 mg|PF-05212384 154 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) and Part 2 (MTD confirmation) of the study.
11376556|NCT00940498|OG001|Outcome|Part 1: PF-05212384 222 mg|PF-05212384 222 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376557|NCT00940498|OG002|Outcome|Part 1: PF-05212384 266 mg|PF-05212384-266 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376558|NCT00940498|OG000|Outcome|PF-05212384 : All Participants|PF-05212384-10,21,43,89,154,222,266,319 milligram (mg) intravenous infusion over approximately 30 minutes once weekly in each 28 day cycle until progression of disease, uncontrollable toxicity, or a decision by the patient or investigator to discontinue.
11376559|NCT00940498|OG000|Outcome|PF-05212384 : All Participants|Entire study population treated with PF-05212384-10,21,43,89,154,222,266,319 mg intravenous infusion over approximately 30 minutes once weekly in each 28 day cycle until progression of disease, uncontrollable toxicity, or a decision by the participant or investigator to discontinue.
11376560|NCT00940498|EG000|Reported Event|Part 1: PF-05212384 10 mg|PF-05212384 10 milligram (mg), intravenous (IV) infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376561|NCT00940498|EG001|Reported Event|Part 1: PF-05212384 21 mg|PF-05212384 21 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376562|NCT00940498|EG002|Reported Event|Part 1: PF-05212384 43 mg|PF-05212384 43 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376563|NCT00940498|EG003|Reported Event|Part 1: PF-05212384 89 mg|PF-05212384 89 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376564|NCT00940498|EG004|Reported Event|Part 1 and 2: PF-05212384 154 mg|PF-05212384 154 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) and Part 2 (MTD confirmation) of the study.
11376565|NCT00940498|EG005|Reported Event|Part 1: PF-05212384 222 mg|PF-05212384 222 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376566|NCT00940498|EG006|Reported Event|Part 1: PF-05212384 266 mg|PF-05212384-266 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11376567|NCT00940498|EG007|Reported Event|Part 1: PF-05212384 319 mg|PF-05212384-319 mg IV infusion, once weekly in each 28-day cycle until progression of disease, uncontrollable toxicity or a decision by the participant or investigator to discontinue during Part 1 (MTD estimation) of the study.
11377172|NCT03853291|EG000|Reported Event|PICT|"Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with dementia, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about their care recipient's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set through routine practice.~PICT: PICT is a manualized, multicomponent intervention delivered by a trained interventionist. PICT consists of 4 weekly telephone sessions (30-60 mins each) guided by an Instructor Manual and companion Caregiver Workbook"
11377173|NCT03853291|EG001|Reported Event|Control Group|"Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.~Information Pamphlet: Pamphlet with information about pain and dementia and links to Alzheimer's Association"
11377174|NCT03853291|EG002|Reported Event|Family Caregivers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions
11190373|NCT02124811|BG000|Baseline|High CRP|Participants with treatment resistant schizophrenia and a high baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values greater than 3 milligrams per liter (mg/L) of blood are considered high.
11190374|NCT02124811|BG001|Baseline|Low CRP|Participants with treatment resistant schizophrenia and a low baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values equal to or less than 3 milligrams per liter (mg/L) of blood are considered low.
11190375|NCT02124811|BG002|Baseline|Total|Total of all reporting groups
11190376|NCT02124811|FG000|Participant Flow|High CRP|Participants with treatment resistant schizophrenia and a high baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values greater than 3 milligrams per liter (mg/L) of blood are considered high.
11190377|NCT02124811|FG001|Participant Flow|Low CRP|Participants with treatment resistant schizophrenia and a low baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values equal to or less than 3 milligrams per liter (mg/L) of blood are considered low.
11190378|NCT02124811|OG000|Outcome|High CRP|Participants with treatment resistant schizophrenia and a high baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values greater than 3 milligrams per liter (mg/L) of blood are considered high.
11372711|NCT00554606|BG000|Baseline|Canakinumab (ACZ885)|Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
10962825|NCT00868608|EG001|Reported Event|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
10850096|NCT00300274|FG002|Participant Flow|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
11190379|NCT02124811|OG001|Outcome|Low CRP|Participants with treatment resistant schizophrenia and a low baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values equal to or less than 3 milligrams per liter (mg/L) of blood are considered low.
11372712|NCT00554606|FG000|Participant Flow|Canakinumab (ACZ885)|Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
11190380|NCT02124811|EG000|Reported Event|High CRP|Participants with treatment resistant schizophrenia and a high baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values greater than 3 milligrams per liter (mg/L) of blood are considered high.
11372713|NCT00554606|OG000|Outcome|Canakinumab (ACZ885)|Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
11372714|NCT00554606|OG000|Outcome|Canakinumab (ACZ885) (Core Trial CACZ885A2204)|Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1, 15 continuing every 4 weeks up to week 26 in the core trial CACZ885A2204.
11372715|NCT00554606|OG001|Outcome|Non- ACZ885 ( (Core Trial CACZ885A2204))|Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
11372716|NCT00554606|EG000|Reported Event|Canakinumab (ACZ885)|Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
11376568|NCT04720547|BG000|Baseline|Zolpidem, Then No Treatment|"Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.~Zolpidem: A nonbenzodiazepine hypnotic~No Treatment: The Control condition in which participants do not receive medication."
11376569|NCT04720547|BG001|Baseline|No Treatment, Then Zolpidem|"Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.~Zolpidem: A nonbenzodiazepine hypnotic~No Treatment: The Control condition in which participants do not receive medication."
11376570|NCT04720547|BG002|Baseline|Total|Total of all reporting groups
11376571|NCT04720547|FG000|Participant Flow|Experimental: Zolpidem, Then No Treatment|"Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.~Zolpidem: A nonbenzodiazepine hypnotic"
11376572|NCT04720547|FG001|Participant Flow|Experimental: No Treatment, Then Zolpidem|Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
11376573|NCT04720547|OG000|Outcome|Zolpidem|Outcomes from the Zolpidem night for participants in both sequences
11376574|NCT04720547|OG001|Outcome|No Treatment|Outcomes from the No Treatment night for participants in both sequences
11376575|NCT04720547|EG000|Reported Event|Zolpidem|Outcomes from the Zolpidem night for participants in both sequences
11376576|NCT04720547|EG001|Reported Event|No Treatment|Outcomes from the No Treatment night for participants in both sequences
11376577|NCT04553913|BG000|Baseline|Overall Subject Numbers|Subjects in the experimental arm serve as their own control.
11376578|NCT04553913|FG000|Participant Flow|All Participants|15 subjects served as their own controls; two methods were used to assess the return of sensation on the same side/same non-operative leg after spinal block at the same time
11376579|NCT04553913|OG000|Outcome|Cooling Device Placed|"A basic medical grade cooling pad will be secured to the non operative leg. Intermittent coolness will be assessed and subject will inform recovery room staff when sensation returns.~cooling device: device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics."
11376580|NCT04553913|OG000|Outcome|Standard of Care no Intervention|Subjects in intervention arm will serve as their own control; standard nursing pinprick testing on the same (non-operative) thigh
11376581|NCT04553913|EG000|Reported Event|All Completed Subjects|Because subjects served as their own control, both groups included together.
11376582|NCT04079452|BG000|Baseline|Doravirine + Descovy® TAF/FTC|"Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) coformulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 4 weeks~Doravirine: Doravirine 100 mg tablet~Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet"
11376583|NCT04079452|FG000|Participant Flow|Doravirie+TAF/FTC Arm (Single Arm)|Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
11376584|NCT04079452|OG000|Outcome|Doravirine+TAF/FTC Arm (Single Arm)|Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
11376585|NCT04079452|OG000|Outcome|Doravirie+TAF/FTC Arm (Single Arm)|Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
11376586|NCT04079452|EG000|Reported Event|Doravirine+TAF/FTC Arm (Single Arm)|Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
11376587|NCT04009824|BG000|Baseline|Group 1: Saline Placebo|Participants received placebo on days 1 and 22 by subcutaneous injection
11376588|NCT04009824|BG001|Baseline|Group 2: AGS-v PLUS Non-Adjuvanted|Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
11376589|NCT04009824|BG002|Baseline|Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo|Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
11376590|NCT04009824|BG003|Baseline|Group 4: AGS-v PLUS + Montanide ISA-51|Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
11376591|NCT04009824|BG004|Baseline|Group 5: AGS-v PLUS + Alhydrogel® Adjuvant|Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
11376592|NCT04009824|BG005|Baseline|Total|Total of all reporting groups
11376593|NCT04009824|FG000|Participant Flow|Group 1: Saline Placebo|Participants received placebo on days 1 and 22 by subcutaneous injection
11376594|NCT04009824|FG001|Participant Flow|Group 2: AGS-v PLUS Non-Adjuvanted|Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
11376595|NCT04009824|FG002|Participant Flow|Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo|Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
11376596|NCT04009824|FG003|Participant Flow|Group 4: AGS-v PLUS + Montanide ISA-51|Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
11376597|NCT04009824|FG004|Participant Flow|Group 5: AGS-v PLUS + Alhydrogel® Adjuvant|Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
11376598|NCT04009824|OG000|Outcome|Group 1: Saline Placebo|Participants received placebo on days 1 and 22 by subcutaneous injection
11190381|NCT02124811|EG001|Reported Event|Low CRP|Participants with treatment resistant schizophrenia and a low baseline C-reactive protein (CRP) level received minocycline augmentation with clozapine. CRP levels were measured by a high sensitivity CRP test (hs-CRP) and baseline values equal to or less than 3 milligrams per liter (mg/L) of blood are considered low.
11372717|NCT00555009|BG000|Baseline|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
11372718|NCT00555009|BG001|Baseline|Placebo|Matching placebo injected SC.
11372719|NCT00555009|BG002|Baseline|Total|Total of all reporting groups
11372720|NCT00555009|FG000|Participant Flow|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
11372721|NCT00555009|FG001|Participant Flow|Placebo|Matching placebo injected SC.
11372722|NCT00555009|OG000|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
11372723|NCT00555009|OG001|Outcome|Placebo|Matching placebo injected SC.
11372724|NCT00555009|EG000|Reported Event|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
11372725|NCT00555009|EG001|Reported Event|Placebo|Matching placebo injected SC.
11376599|NCT04009824|OG001|Outcome|Group 2: AGS-v PLUS Non-Adjuvanted|Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
11376600|NCT04009824|OG002|Outcome|Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo|Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
11190382|NCT02124863|BG000|Baseline|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
11376601|NCT04009824|OG003|Outcome|Group 4: AGS-v PLUS + Montanide ISA-51|Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
11376602|NCT04009824|OG004|Outcome|Group 5: AGS-v PLUS + Alhydrogel® Adjuvant|Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
11376603|NCT04009824|EG000|Reported Event|Group 1: Saline Placebo|Participants received placebo on days 1 and 22 by subcutaneous injection
11376604|NCT04009824|EG001|Reported Event|Group 2: AGS-v PLUS Non-Adjuvanted|Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
11376605|NCT04009824|EG002|Reported Event|Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo|Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
11376606|NCT04009824|EG003|Reported Event|Group 4: AGS-v PLUS + Montanide ISA-51|Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
11376607|NCT04009824|EG004|Reported Event|Group 5: AGS-v PLUS + Alhydrogel® Adjuvant|Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
11377175|NCT03853291|EG003|Reported Event|Healthcare Providers - Interview Phase|Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377176|NCT03853291|EG004|Reported Event|Family Caregivers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377177|NCT03853291|EG005|Reported Event|Healthcare Providers - Field Test Phase|Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
11377178|NCT03850444|BG000|Baseline|Pembrolizumab-China Extension|Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles)
10850097|NCT00300274|OG000|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
11372726|NCT00565461|BG000|Baseline|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
10850098|NCT00300274|OG001|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
10962826|NCT00868608|EG002|Reported Event|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
10962827|NCT00868699|BG000|Baseline|Placebo|Placebo : Placebo Comparator
10850099|NCT00300274|OG002|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
10962828|NCT00868699|BG001|Baseline|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
10962829|NCT00868699|BG002|Baseline|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
10962830|NCT00868699|BG003|Baseline|Total|Total of all reporting groups
11372727|NCT00565461|BG001|Baseline|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372728|NCT00565461|BG002|Baseline|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372729|NCT00565461|BG003|Baseline|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372730|NCT00565461|BG004|Baseline|Total|Total of all reporting groups
11372731|NCT00565461|FG000|Participant Flow|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372732|NCT00565461|FG001|Participant Flow|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372733|NCT00565461|FG002|Participant Flow|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372734|NCT00565461|FG003|Participant Flow|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372735|NCT00565461|OG000|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
11372736|NCT00565461|OG001|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
11372737|NCT00565461|OG000|Outcome|Group 1|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372738|NCT00565461|OG001|Outcome|Group 2|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372739|NCT00565461|OG002|Outcome|Group 3|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372740|NCT00565461|OG003|Outcome|Group 4|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372741|NCT00565461|OG000|Outcome|Clinician-administered - Group 1|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: deltoid"
11372742|NCT00565461|OG001|Outcome|Clinician Administered (Deltoid/ Thigh) - Group 2|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
11372743|NCT00565461|OG000|Outcome|Group 3|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372744|NCT00565461|OG001|Outcome|Group 4|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372745|NCT00565461|EG000|Reported Event|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372746|NCT00565461|EG001|Reported Event|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11372747|NCT00565461|EG002|Reported Event|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11240460|NCT02479412|FG004|Participant Flow|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11372748|NCT00565461|EG003|Reported Event|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
11376608|NCT03867383|BG000|Baseline|Calcium Chloride|"Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Calcium Chloride: All included in intervention description.~1 gram of calcium chloride in total 60 milliliters normal saline"
11376609|NCT03867383|BG001|Baseline|Placebo|"Non-participating anesthesiologist prepares the placebo solution, which is 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour.~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Placebo: 60 milliliters normal saline"
11376610|NCT03867383|BG002|Baseline|Total|Total of all reporting groups
11376611|NCT03867383|FG000|Participant Flow|Calcium Chloride|"Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Calcium Chloride: All included in intervention description.~1 gram of calcium chloride in total 60 milliliters normal saline"
11376612|NCT03867383|FG001|Participant Flow|Placebo|"Non-participating anesthesiologist prepares the placebo solution, which is 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour.~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Placebo: 60 milliliters normal saline"
11376613|NCT03867383|OG000|Outcome|Calcium Chloride|"Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Calcium Chloride: All included in intervention description.~1 gram of calcium chloride in total 60 milliliters normal saline"
11376614|NCT03867383|OG001|Outcome|Placebo|"Non-participating anesthesiologist prepares the placebo solution, which is 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour.~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Placebo: 60 milliliters normal saline"
11376615|NCT03867383|OG000|Outcome|All Participants|All participants who consented to phlebotomy for ionized calcium level analysis
11376616|NCT03867383|EG000|Reported Event|Calcium Chloride|"Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Calcium Chloride: All included in intervention description.~1 gram of calcium chloride in total 60 milliliters normal saline"
11376617|NCT03867383|EG001|Reported Event|Placebo|"Non-participating anesthesiologist prepares the placebo solution, which is 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour.~This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.~Placebo: 60 milliliters normal saline"
11372749|NCT00566995|BG000|Baseline|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
11372750|NCT00566995|FG000|Participant Flow|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
11372751|NCT00566995|OG000|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
11372752|NCT00566995|EG000|Reported Event|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
11376618|NCT03449758|BG000|Baseline|Sarilumab|Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
11376619|NCT03449758|FG000|Participant Flow|Sarilumab|Sarilumab 200 mg subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARD) during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
11376620|NCT03449758|OG000|Outcome|Sarilumab|Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
10962831|NCT00868699|FG000|Participant Flow|Placebo|Placebo : Placebo Comparator
11376621|NCT03449758|OG000|Outcome|Sarilumab|Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months core treatment period. Participants who completed the 24 weeks period had an option to continue in a long-term extension treatment period and received sarilumab 200 mg q2w until the commercial availability of sarilumab in the country or maximum of 39.7 weeks.
11376622|NCT03449758|EG000|Reported Event|Sarilumab|Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to 39.7 weeks.
11376623|NCT03222973|BG000|Baseline|Part 1: Placebo|Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376624|NCT03222973|BG001|Baseline|Part 1: BIIB033 750 mg|Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376625|NCT03222973|BG002|Baseline|Total|Total of all reporting groups
11376626|NCT03222973|FG000|Participant Flow|Part 1: Placebo|Participants with RMS received placebo intravenously (IV) as an add-on therapy to a background disease-modifying therapy (DMT) once every 4 weeks over 72 weeks.
11376627|NCT03222973|FG001|Participant Flow|Part 1: BIIB033 750 mg|Participants with RMS received BIIB033 750 milligrams (mg) IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376628|NCT03222973|FG002|Participant Flow|Part 2: Placebo to BIIB033 750 mg|Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
11376629|NCT03222973|FG003|Participant Flow|Part 2: BIIB033 750 mg|Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
11376630|NCT03222973|OG000|Outcome|Part 1: Placebo|Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376631|NCT03222973|OG001|Outcome|Part 1: BIIB033 750 mg|Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376632|NCT03222973|OG000|Outcome|Part 2: Placebo to BIIB033 750 mg|Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
11376633|NCT03222973|OG001|Outcome|Part 2: BIIB033 750 mg|Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
11376634|NCT03222973|EG000|Reported Event|Part 1: Placebo|Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376635|NCT03222973|EG001|Reported Event|Part 1: BIIB033 750 mg|Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
11376636|NCT03222973|EG002|Reported Event|Part 2: Placebo to BIIB033 750 mg|Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
11376637|NCT03222973|EG003|Reported Event|Part 2: BIIB033 750 mg|Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
11240461|NCT02479412|FG005|Participant Flow|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11372753|NCT00586924|BG000|Baseline|5 mcg/kg|Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372754|NCT00586924|BG001|Baseline|10 mcg/kg|Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372755|NCT00586924|BG002|Baseline|20 mcg/kg|Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372756|NCT00586924|BG003|Baseline|30 mcg/kg|Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372757|NCT00586924|BG004|Baseline|40 mcg/kg|Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372758|NCT00586924|BG005|Baseline|50 mcg/kg|Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372759|NCT00586924|BG006|Baseline|Total|Total of all reporting groups
11372760|NCT00586924|FG000|Participant Flow|5 mcg/kg|Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372761|NCT00586924|FG001|Participant Flow|10 mcg/kg|Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372762|NCT00586924|FG002|Participant Flow|20 mcg/kg|Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372763|NCT00586924|FG003|Participant Flow|30 mcg/kg|Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
10962832|NCT00868699|FG001|Participant Flow|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
11372764|NCT00586924|FG004|Participant Flow|40 mcg/kg|Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372765|NCT00586924|FG005|Participant Flow|50 mcg/kg|Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372766|NCT00586924|OG000|Outcome|5 mcg/kg|Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372767|NCT00586924|OG001|Outcome|10 mcg/kg|Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372768|NCT00586924|OG002|Outcome|20 mcg/kg|Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372769|NCT00586924|OG003|Outcome|30 mcg/kg|Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372770|NCT00586924|OG004|Outcome|40 mcg/kg|Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372771|NCT00586924|OG005|Outcome|50 mcg/kg|Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11190383|NCT02124863|FG000|Participant Flow|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
10850100|NCT00300274|EG000|Reported Event|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
11190384|NCT02124863|OG000|Outcome|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
11190385|NCT02124863|OG001|Outcome|Control|mean number of refluxes during 20 min, 120 min after each meal
10850101|NCT00300274|EG001|Reported Event|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
11372772|NCT00586924|EG000|Reported Event|5 mcg/kg|Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
10962833|NCT00868699|FG002|Participant Flow|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
10962834|NCT00868699|OG000|Outcome|Placebo|Placebo : Placebo Comparator
10962835|NCT00868699|OG001|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
10962836|NCT00868699|OG002|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
10962837|NCT00868699|EG000|Reported Event|Placebo|Placebo : Placebo Comparator
10850102|NCT00300274|EG002|Reported Event|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
11372773|NCT00586924|EG001|Reported Event|10 mcg/kg|Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372774|NCT00586924|EG002|Reported Event|20 mcg/kg|Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372775|NCT00586924|EG003|Reported Event|30 mcg/kg|Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372776|NCT00586924|EG004|Reported Event|40 mcg/kg|Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11372777|NCT00586924|EG005|Reported Event|50 mcg/kg|Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
11376638|NCT03187262|BG000|Baseline|Daratumumab|"Daratumumab will be administered in three phases: Induction, consolidation and maintenance~During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day~During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle~During maintenance, daratumumab will be administered on day 1 of each 28-day cycle~Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories"
11376639|NCT03187262|FG000|Participant Flow|Daratumumab|"Daratumumab will be administered in three phases: Induction, consolidation and maintenance~During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day~During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle~During maintenance, daratumumab will be administered on day 1 of each 28-day cycle~Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories"
11376640|NCT03187262|OG000|Outcome|Daratumumab|"Daratumumab will be administered in three phases: Induction, consolidation and maintenance~During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day~During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle~During maintenance, daratumumab will be administered on day 1 of each 28-day cycle~Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories"
11376641|NCT03187262|EG000|Reported Event|Daratumumab|"Daratumumab will be administered in three phases: Induction, consolidation and maintenance~During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day~During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle~During maintenance, daratumumab will be administered on day 1 of each 28-day cycle~Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories"
11376642|NCT03137693|BG000|Baseline|All Participants|All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
11376643|NCT03137693|FG000|Participant Flow|All Participants|All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
11376644|NCT03137693|OG000|Outcome|All Participants|All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
11376645|NCT03137693|EG000|Reported Event|All Participants|All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
11376646|NCT02987959|BG000|Baseline|TAK-228 Treatment|"Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228~TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2)."
11376647|NCT02987959|FG000|Participant Flow|TAK-228 Treatment|"Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228~TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2)."
11376648|NCT02987959|OG000|Outcome|TAK-228 Treatment|"Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228~TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2)."
11376649|NCT02987959|EG000|Reported Event|TAK-228 Treatment|"Patients with complex genomic sarcomas exhibiting PI3K pathway dysregulation will be treated with TAK-228~TAK-228: TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2)."
11376650|NCT02985541|BG000|Baseline|Levonorgestrel IUS (Mirena, BAY86-5028)|Mirena during extended use (Years 6 to 8).
11376651|NCT02985541|FG000|Participant Flow|Levonorgestrel IUS (Mirena, BAY86-5028)|Mirena during extended use (Years 6 to 8).
11376652|NCT02985541|OG000|Outcome|Levonorgestrel IUS (Mirena, BAY86-5028)|Mirena during extended use (Years 6 to 8).
11376653|NCT02985541|EG000|Reported Event|Levonorgestrel IUS (Mirena, BAY86-5028)|Mirena during extended use (Years 6 to 8).
10962838|NCT00868699|EG001|Reported Event|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
11372778|NCT00588861|BG000|Baseline|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
10962839|NCT00868699|EG002|Reported Event|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
10962840|NCT00868712|BG000|Baseline|Warfarin Use Short Duration|Warfarin use for less than 6 months
10962841|NCT00868712|BG001|Baseline|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
10962842|NCT00868712|BG002|Baseline|3 - Warfarin Use Chronic|Warfarin use >24 months
11190386|NCT02124863|EG000|Reported Event|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
11190387|NCT02124863|EG001|Reported Event|Control|mean number of refluxes during 20 min, 120 min after each meal
11190388|NCT02124889|BG000|Baseline|Weekly Surveys|"Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.~Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication."
10850103|NCT00300365|BG000|Baseline|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
10850104|NCT00300365|BG001|Baseline|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
10850105|NCT00300365|BG002|Baseline|Total|Total of all reporting groups
10962843|NCT00868712|BG003|Baseline|Total|Total of all reporting groups
10850106|NCT00300365|FG000|Participant Flow|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and aspirin 325 mg
10850107|NCT00300365|FG001|Participant Flow|Active Pioglitazone + Open-Label Niacin + Aspirin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and aspirin 325 mg. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
10850108|NCT00300365|OG000|Outcome|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
11372779|NCT00588861|BG001|Baseline|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
11372780|NCT00588861|BG002|Baseline|Total|Total of all reporting groups
11372781|NCT00588861|FG000|Participant Flow|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
11372782|NCT00588861|FG001|Participant Flow|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
11372783|NCT00588861|OG000|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
11372784|NCT00588861|OG001|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
11372785|NCT00588861|EG000|Reported Event|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
11372786|NCT00588861|EG001|Reported Event|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
11376654|NCT02960893|BG000|Baseline|Troriluzole - Randomization Phase|Participants received Troriluzole 140 milligram (mg) capsules orally once daily (QD) for 8 weeks.
11376655|NCT02960893|BG001|Baseline|Placebo - Randomization Phase|Participants received matching placebo capsules orally QD for 8 weeks.
11376656|NCT02960893|BG002|Baseline|Total|Total of all reporting groups
11376657|NCT02960893|FG000|Participant Flow|Troriluzole/Randomization-Troriluzole/Extension|"Troriluzole - Randomization Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 8 weeks.~Troriluzole - Extension Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 48 weeks."
11376658|NCT02960893|FG001|Participant Flow|Placebo/Randomization-Troriluzole/Extension|"Placebo - Randomization Phase: Participants received matching placebo capsules orally once daily (QD) for 8 weeks.~Troriluzole - Extension Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 48 weeks."
11376659|NCT02960893|OG000|Outcome|Troriluzole - Randomization Phase|Participants received Troriluzole 140 milligram (mg) capsules orally (QD) for 8 weeks.
11376660|NCT02960893|OG001|Outcome|Placebo - Randomization Phase|Participants received matching placebo capsules orally QD for 8 weeks.
11376661|NCT02960893|OG000|Outcome|Troriluzole/Troriluzole - Extension Phase|Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
11376662|NCT02960893|OG001|Outcome|Placebo/Troriluzole - Extension Phase|Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
11376663|NCT02960893|OG000|Outcome|Troriluzole - Overall|Participants received at least one dose of Troriluzole 140 mg capsule orally QD during the Randomization Phase or Extension Phase.
11376664|NCT02960893|OG000|Outcome|Troriluzole - Randomization Phase|Participants received Troriluzole 140 milligram (mg) capsules orally once daily (QD) for 8 weeks.
11376665|NCT02960893|OG000|Outcome|Troriluzole - Extension Phase|Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
11376666|NCT02960893|EG000|Reported Event|Troriluzole - Randomization Phase|Participants received Troriluzole 140 milligram (mg) capsules orally once daily (QD) for 8 weeks.
11376667|NCT02960893|EG001|Reported Event|Placebo - Randomization Phase|Participants received matching placebo capsules orally QD for 8 weeks.
11376668|NCT02960893|EG002|Reported Event|Troriluzole/Troriluzole - Extension Phase|Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
11376669|NCT02960893|EG003|Reported Event|Placebo/Troriluzole - Extension Phase|Participants received Troriluzole 140 mg capsules orally QD for 48 weeks.
11376670|NCT02940522|BG000|Baseline|Treatment A|"Subcutaneous (SQ) injection using an autoinjector~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376671|NCT02940522|BG001|Baseline|Treatment B|"Intramuscular injection (IM) using syringe and needle~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376672|NCT02940522|BG002|Baseline|Total|Total of all reporting groups
11376673|NCT02940522|FG000|Participant Flow|Treatment A|"Subcutaneous (SQ) injection using an autoinjector~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376674|NCT02940522|FG001|Participant Flow|Treatment B|"Intramuscular injection (IM) using syringe and needle~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376675|NCT02940522|OG000|Outcome|Treatment A|"Subcutaneous (SQ) injection using an autoinjector~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376676|NCT02940522|OG001|Outcome|Treatment B|"Intramuscular injection (IM) using syringe and needle~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376677|NCT02940522|EG000|Reported Event|Treatment A|"Subcutaneous (SQ) injection using an autoinjector~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11376678|NCT02940522|EG001|Reported Event|Treatment B|"Intramuscular injection (IM) using syringe and needle~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11377179|NCT03850444|BG001|Baseline|Chemotherapy (SOC Treatment)-China Extension|Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11377180|NCT03850444|BG002|Baseline|Total|Total of all reporting groups
11377181|NCT03850444|FG000|Participant Flow|Pembrolizumab-China Extension|Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles)
10962844|NCT00868712|FG000|Participant Flow|Warfarin Use Short Duration|Warfarin use for less than 6 months
10962845|NCT00868712|FG001|Participant Flow|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
10962846|NCT00868712|FG002|Participant Flow|3 - Warfarin Use Chronic|Warfarin use >24 months
10962847|NCT00868712|OG000|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
10962848|NCT00868712|OG001|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
11372787|NCT00602030|BG000|Baseline|Lead-in Phase: Erlotinib + Entinostat 5 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372788|NCT00602030|BG001|Baseline|Lead-in Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372789|NCT00602030|BG002|Baseline|Double-blind Phase: Erlotinib + Placebo|Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372790|NCT00602030|BG003|Baseline|Double-blind Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372791|NCT00602030|BG004|Baseline|Total|Total of all reporting groups
11372792|NCT00602030|FG000|Participant Flow|Lead-in Phase: Erlotinib + Entinostat 5 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372793|NCT00602030|FG001|Participant Flow|Lead-in Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372794|NCT00602030|FG002|Participant Flow|Double-blind Phase: Erlotinib + Placebo|Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372795|NCT00602030|FG003|Participant Flow|Double-blind Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372796|NCT00602030|FG004|Participant Flow|Crossover Phase: Erlotinib + Entinostat 10 mg|Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
11372797|NCT00602030|OG000|Outcome|Lead-in Phase: Erlotinib + Entinostat|Participants received erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg or 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle for up to 6 cycles in the Open-label Lead-in Phase 1 dose-finding study to identify a safe dose of entinostat in combination with erlotinib for further evaluation.
11372798|NCT00602030|OG000|Outcome|Double-blind Phase: Erlotinib + Placebo|Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372799|NCT00602030|OG001|Outcome|Double-blind Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372800|NCT00602030|OG000|Outcome|Lead-in Phase: Erlotinib + Entinostat 5 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372801|NCT00602030|OG001|Outcome|Lead-in Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372802|NCT00602030|EG000|Reported Event|Lead-in Phase: Erlotinib + Entinostat 5 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372803|NCT00602030|EG001|Reported Event|Lead-in Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.
11372804|NCT00602030|EG002|Reported Event|Double-blind Phase: Erlotinib + Placebo|Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372805|NCT00602030|EG003|Reported Event|Double-blind Phase: Erlotinib + Entinostat 10 mg|Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.
11372806|NCT00602030|EG004|Reported Event|Crossover Phase: Erlotinib + Entinostat 10 mg|Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
11372807|NCT03288142|BG000|Baseline|Hypertension Coaching Application and Home Monitor|Arm assigned hypertension coaching application and home monitor
11372808|NCT03288142|BG001|Baseline|Tracking Application and Home Monitor|Arm assigned tracking application and home monitor
11372809|NCT03288142|BG002|Baseline|Total|Total of all reporting groups
11190389|NCT02124889|BG001|Baseline|No Survey - Control|Subjects will take the multivitamin but will not receive surveys.
11190390|NCT02124889|BG002|Baseline|Total|Total of all reporting groups
11190391|NCT02124889|FG000|Participant Flow|Weekly Surveys|"Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.~Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication."
11190392|NCT02124889|FG001|Participant Flow|No Survey|Group will only get multivitamin - no weekly survey
11190393|NCT02124889|OG000|Outcome|Weekly Surveys|"Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.~Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication."
11190394|NCT02124889|OG001|Outcome|No Survey|Subjects will take the multivitamin.
11190395|NCT02124889|EG000|Reported Event|Weekly Surveys|"Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.~Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication."
11190396|NCT02124889|EG001|Reported Event|No Survey - Control|Subjects will take the multivitamin without additional contact.
11190397|NCT02125279|BG000|Baseline|Calcitriol 3 mcg/g|Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
11190398|NCT02125279|FG000|Participant Flow|Calcitriol 3 mcg/g|Participants received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
11190399|NCT02125279|OG000|Outcome|Calcitriol 3 mcg/g|Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
11190400|NCT02125279|OG000|Outcome|Calcitriol 3 mcg/g|Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks.Participants were further followed up for 4 weeks.
11376679|NCT02711137|BG000|Baseline|Part1/Treatment Group A : 8mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
10962849|NCT00868712|OG002|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
10962850|NCT00868712|EG000|Reported Event|Warfarin Use Short Duration|Warfarin use for less than 6 months
10962851|NCT00868712|EG001|Reported Event|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
10962852|NCT00868712|EG002|Reported Event|3 - Warfarin Use Chronic|Warfarin use >24 months
11376680|NCT02711137|BG001|Baseline|Part1/Treatment Group A : 12mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11190401|NCT02125279|OG000|Outcome|Calcitriol 3 mcg/g|Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
11190402|NCT02125279|EG000|Reported Event|Calcitriol 3 mcg/g|Participants received calcitriol 3 mcg/g ointment twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
11190403|NCT02125292|BG000|Baseline|All Participants|
11191774|NCT02133742|OG000|Outcome|Axitinib 5 mg + Pembrolizumab (MK-3475) 2 mg|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days). Participants received axitinib up to a maximum of 64 cycles and pembrolizumab up to 56 cycles in dose expansion phase (each cycle of 21 days) until documented disease progression or unacceptable toxicity or study discontinuation criteria were met.
11191775|NCT02133742|OG000|Outcome|Axitinib 5 mg + Pembrolizumab (MK-3475) 2 mg|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days or lead-in day 21). Participants received axitinib up to a maximum of 64 cycles and pembrolizumab up to 56 cycles in dose expansion phase (each cycle of 21 days or lead-in day 21) until documented disease progression or unacceptable toxicity or study discontinuation criteria were met.
11240462|NCT02479412|FG006|Participant Flow|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11376681|NCT02711137|BG002|Baseline|Part1/Treatment Group A : 16mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11372810|NCT03288142|FG000|Participant Flow|Hypertension Coaching Application and Home Monitor|"The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (Lark HTN Pro), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app."
11372811|NCT03288142|FG001|Participant Flow|Tracking Application and Home Monitor|Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
11372812|NCT03288142|OG000|Outcome|Control|Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
11372813|NCT03288142|OG001|Outcome|Intervention|"The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (Lark HTN Pro), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.~Lark HTN Pro: The intervention group will have the HPCP"
11372814|NCT03288142|OG000|Outcome|Intervention|"The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (Lark HTN Pro), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.~Lark HTN Pro: The intervention group will have the HPCP"
11372815|NCT03288142|OG001|Outcome|Control|Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
11372816|NCT03288142|EG000|Reported Event|Intervention|"The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (Lark HTN Pro), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app."
11372817|NCT03288142|EG001|Reported Event|Control|Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
11372818|NCT03112603|BG000|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice per day at a dose of 10 mg.
11240463|NCT02479412|FG007|Participant Flow|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
10962853|NCT00868751|BG000|Baseline|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
11240464|NCT02479412|FG008|Participant Flow|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11240465|NCT02479412|OG000|Outcome|AZD7594|AZD7594 DPI once daily
10850109|NCT00300365|OG001|Outcome|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
10962854|NCT00868751|FG000|Participant Flow|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
11240466|NCT02479412|OG001|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11240467|NCT02479412|OG000|Outcome|AZD7594|AZD7594 DPI once daily.
11240468|NCT02479412|OG000|Outcome|Placebo|Placebo for AZD7594 DPI once daily
10850110|NCT00300365|EG000|Reported Event|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
11240469|NCT02479412|OG001|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11240470|NCT02479412|OG002|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11240471|NCT02479412|OG003|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11372819|NCT03112603|BG001|Baseline|Best Available Therapy|Best available therapies including but not limited to extracorporeal photopheresis (ECP),low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab ,pentostatin, imatinib and ibrutinib based on investigators decision.
11372820|NCT03112603|BG002|Baseline|Total|Total of all reporting groups
11372821|NCT03112603|FG000|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice per day at a dose of 10 mg.
11372822|NCT03112603|FG001|Participant Flow|Best Available Therapy|Best available therapies including but not limited to extracorporeal photopheresis (ECP),low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab ,pentostatin, imatinib and ibrutinib based on investigators decision.
11372823|NCT03112603|FG002|Participant Flow|Ruxolitinib -Cross Over Period|Participants from BAT arm at the end of cycle 6 crossed over to ruxolitinib treatment
11372824|NCT03112603|OG000|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice per day at a dose of 10 mg.
11372825|NCT03112603|OG001|Outcome|Best Available Therapy|Best available therapies including but not limited to extracorporeal photopheresis (ECP),low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab ,pentostatin, imatinib and ibrutinib based on investigators decision.
11372826|NCT03112603|EG000|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice per day at a dose of 10 mg.
11372827|NCT03112603|EG001|Reported Event|Best Available Therapy|Best available therapies including but not limited to extracorporeal photopheresis (ECP),low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab ,pentostatin, imatinib and ibrutinib based on investigators decision.
11372828|NCT02908672|BG000|Baseline|Atezolizumab Placebo + Cobimetinib + Vemurafenib|Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372829|NCT02908672|BG001|Baseline|Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo|Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372830|NCT02908672|BG002|Baseline|Total|Total of all reporting groups
11372831|NCT02908672|FG000|Participant Flow|Atezolizumab Placebo + Cobimetinib + Vemurafenib|Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372832|NCT02908672|FG001|Participant Flow|Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo|Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372833|NCT02908672|OG000|Outcome|Atezolizumab Placebo + Cobimetinib + Vemurafenib|Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11376682|NCT02711137|BG003|Baseline|Part1/Treatment Group B : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
11376683|NCT02711137|BG004|Baseline|Part1/Treatment Group B : 12mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
11240472|NCT02479412|OG000|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11240473|NCT02479412|OG001|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11372834|NCT02908672|OG001|Outcome|Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo|Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372835|NCT02908672|EG000|Reported Event|Atezolizumab Placebo + Cobimetinib + Vemurafenib|Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11372836|NCT02908672|EG001|Reported Event|Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo|Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
11376684|NCT02711137|BG005|Baseline|Part1/Treatment Group C : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
11376685|NCT02711137|BG006|Baseline|Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11376686|NCT02711137|BG007|Baseline|Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11376687|NCT02711137|BG008|Baseline|Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg|Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
11376688|NCT02711137|BG009|Baseline|Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376689|NCT02711137|BG010|Baseline|Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376690|NCT02711137|BG011|Baseline|Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
11376691|NCT02711137|BG012|Baseline|Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
11376692|NCT02711137|BG013|Baseline|Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
11376693|NCT02711137|BG014|Baseline|Enrolled But Not Dosed|3 participants enrolled in the study and discontinued the study before study drug is administered
11376694|NCT02711137|BG015|Baseline|Total|Total of all reporting groups
11376695|NCT02711137|FG000|Participant Flow|Part1/Treatment Group A : 8mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11240474|NCT02479412|OG002|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11240475|NCT02479412|EG000|Reported Event|Placebo (PBO)|Placebo for AZD7594 DPI once daily
11240476|NCT02479412|EG001|Reported Event|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11190404|NCT02125292|FG000|Participant Flow|Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11190405|NCT02125292|FG001|Participant Flow|Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11190406|NCT02125292|FG002|Participant Flow|Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11240477|NCT02479412|EG002|Reported Event|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11376696|NCT02711137|FG001|Participant Flow|Part1/Treatment Group A : 12mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11240478|NCT02479412|EG003|Reported Event|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11240479|NCT02479763|BG000|Baseline|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
11240480|NCT02479763|BG001|Baseline|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11190407|NCT02125292|FG003|Participant Flow|Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11190408|NCT02125292|FG004|Participant Flow|Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11190409|NCT02125292|FG005|Participant Flow|Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
11190410|NCT02125292|OG000|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190411|NCT02125292|OG001|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190412|NCT02125292|OG002|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190413|NCT02125292|OG000|Outcome|All Participants|All participants who received all 3 treatments
11190414|NCT02125292|EG000|Reported Event|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190415|NCT02125292|EG001|Reported Event|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190416|NCT02125292|EG002|Reported Event|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
11190417|NCT02125331|BG000|Baseline|PDM-SuperSTAT|"PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11190418|NCT02125331|BG001|Baseline|PSM-Datex-Ohmeda|"PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11190419|NCT02125331|BG002|Baseline|Total|Total of all reporting groups
11190420|NCT02125331|FG000|Participant Flow|PDM-SuperSTAT|"PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11190421|NCT02125331|FG001|Participant Flow|PSM-Datex-Ohmeda|"PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11240481|NCT02479763|BG002|Baseline|Total|Total of all reporting groups
11240482|NCT02479763|FG000|Participant Flow|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
11240483|NCT02479763|FG001|Participant Flow|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11240484|NCT02479763|OG000|Outcome|Conventional Loss-of-resistance|
11190422|NCT02125331|OG000|Outcome|PDM-SuperSTAT|"PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650~The result of the analysis of mean blood pressure measurement errors shows the PDM-SuperSTAT arm population groups ≥ 3 years old and < 3 years old passed the acceptance criteria. However, the Chronic AFib subgroup population of ≥ 3- years old did not meet the subject enrollment because of the challenging population; but as a group, the NIBP determinations for the PDM-SuperSTAT arm for both population group of ≥ 3 years old and < 3 years old showed the study conformed to ISO 81060-2:2013(E) standards."
11190423|NCT02125331|OG001|Outcome|PSM-Datex-Ohmeda|"PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650~For the PSM-Datex-Ohmeda arm population group ≥ 3 years old and < 3 years old that was prematurely terminated as a result of the business decision that the data was no longer needed to satisfy the business requirements, as a whole, did not meet the ISO 81060-2:2013(E) standards; therefore, PASS/FAIL criteria were unable to be determined."
11190424|NCT02125331|EG000|Reported Event|PDM-SuperSTAT|"PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11190425|NCT02125331|EG001|Reported Event|PSM-Datex-Ohmeda|"PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650~Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization"
11190426|NCT02125604|BG000|Baseline|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
11190427|NCT02125604|FG000|Participant Flow|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
11190428|NCT02125604|OG000|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
11190429|NCT02125604|EG000|Reported Event|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
11190430|NCT02125721|BG000|Baseline|CBTD Patients|Part 1: patients will stop taking CBTDs for seven days and perform a 24-hour urine collection on day 7 Part 2: patients will take their usual CBTD, either tiopronin or d-penicillamine, 1g per day for 7 days, taken as 500 mg twice a day Part 3: patients will take a total of 2g of tiopronin or D-penicillamine daily for 7 days Part 4: patients will take a total of 3g/d of tiopronin or D-penicillamine, also for a 7 day period
11190431|NCT02125721|FG000|Participant Flow|CBTD Patients|Part 1: patients will stop taking CBTDs for seven days and perform a 24-hour urine collection on day 7 Part 2: patients will take their usual CBTD, either tiopronin or d-penicillamine, 1g per day for 7 days, taken as 500 mg twice a day Part 3: patients will take a total of 2g of tiopronin or D-penicillamine daily for 7 days Part 4: patients will take a total of 3g/d of tiopronin or D-penicillamine, also for a 7 day period
11190432|NCT02125721|OG000|Outcome|Increasing Doses of CBTD|"Intervention: CBTD 0-3 gm~CBTD 0-3 gm: Oral CBTD 0-3 gm dose/day for 7 days, dose escalation"
11190433|NCT02125721|EG000|Reported Event|CBTD Patients|Part 1: patients will stop taking CBTDs for seven days and perform a 24-hour urine collection on day 7 Part 2: patients will take their usual CBTD, either tiopronin or d-penicillamine, 1g per day for 7 days, taken as 500 mg twice a day Part 3: patients will take a total of 2g of tiopronin or D-penicillamine daily for 7 days Part 4: patients will take a total of 3g/d of tiopronin or D-penicillamine, also for a 7 day period
11190434|NCT02125734|BG000|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
11190435|NCT02125734|BG001|Baseline|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
11190436|NCT02125734|BG002|Baseline|Total|Total of all reporting groups
11190437|NCT02125734|FG000|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
11190438|NCT02125734|FG001|Participant Flow|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
11190439|NCT02125734|OG000|Outcome|QVA149|
11190440|NCT02125734|OG001|Outcome|Tiotropium|
11190441|NCT02125734|EG000|Reported Event|QVA149|QVA149
11190442|NCT02125734|EG001|Reported Event|Tiotropium|Tiotropium
11190443|NCT02125838|BG000|Baseline|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
11190444|NCT02125838|BG001|Baseline|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
11190445|NCT02125838|BG002|Baseline|Total|Total of all reporting groups
11190446|NCT02125838|FG000|Participant Flow|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
11240485|NCT02479763|OG001|Outcome|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11240486|NCT02479763|EG000|Reported Event|Conventional Loss-of-resistance|
11240487|NCT02479763|EG001|Reported Event|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11190447|NCT02125838|FG001|Participant Flow|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
11190448|NCT02125838|OG000|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
11190449|NCT02125838|OG001|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
11190450|NCT02125838|EG000|Reported Event|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
11190451|NCT02125838|EG001|Reported Event|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
11190452|NCT02125877|BG000|Baseline|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
11190453|NCT02125877|BG001|Baseline|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
11190454|NCT02125877|BG002|Baseline|Total|Total of all reporting groups
11190455|NCT02125877|FG000|Participant Flow|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
11190456|NCT02125877|FG001|Participant Flow|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
11190457|NCT02125877|OG000|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
11190458|NCT02125877|OG001|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
11190459|NCT02125877|EG000|Reported Event|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
11190460|NCT02125877|EG001|Reported Event|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
11190461|NCT02126306|BG000|Baseline|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190462|NCT02126306|BG001|Baseline|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190463|NCT02126306|BG002|Baseline|Total|Total of all reporting groups
11190464|NCT02126306|FG000|Participant Flow|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190465|NCT02126306|FG001|Participant Flow|Beta Glucosylceramide|"Beta Glucosylceramide 7.5 mg~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190466|NCT02126306|OG000|Outcome|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
11190467|NCT02126306|OG001|Outcome|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
11190468|NCT02126306|EG000|Reported Event|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190469|NCT02126306|EG001|Reported Event|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
11190470|NCT02126319|BG000|Baseline|Cognitive Affective Preparation|"Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
11190471|NCT02126319|BG001|Baseline|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
11190472|NCT02126319|BG002|Baseline|Total|Total of all reporting groups
11190473|NCT02126319|FG000|Participant Flow|Cognitive Affective Preparation|"Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
11190474|NCT02126319|FG001|Participant Flow|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
11190475|NCT02126319|OG000|Outcome|Cognitive Affective Preparation|"Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
11190476|NCT02126319|OG001|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
11190477|NCT02126319|OG000|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
10850111|NCT00300365|EG001|Reported Event|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
11190478|NCT02126319|OG001|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
11190479|NCT02126319|EG000|Reported Event|Cognitive Affective Preparation|"Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
11190480|NCT02126319|EG001|Reported Event|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
11190481|NCT02126670|BG000|Baseline|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
11376697|NCT02711137|FG002|Participant Flow|Part1/Treatment Group A : 16mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
10850112|NCT00300391|BG000|Baseline|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
11190482|NCT02126670|BG001|Baseline|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
11190483|NCT02126670|BG002|Baseline|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
11190484|NCT02126670|BG003|Baseline|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
11190485|NCT02126670|BG004|Baseline|Total|Total of all reporting groups
11190486|NCT02126670|FG000|Participant Flow|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
11190487|NCT02126670|FG001|Participant Flow|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
11190488|NCT02126670|FG002|Participant Flow|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
11190489|NCT02126670|FG003|Participant Flow|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
11190490|NCT02126670|OG000|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
11190491|NCT02126670|OG001|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
11190492|NCT02126670|OG002|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
11190493|NCT02126670|OG003|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
11190494|NCT02126670|EG000|Reported Event|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
11190495|NCT02126670|EG001|Reported Event|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
11190496|NCT02126670|EG002|Reported Event|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
11190497|NCT02126670|EG003|Reported Event|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
11190498|NCT02126748|BG000|Baseline|Intrapulmonary Percussive Ventilation|20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
11190499|NCT02126748|BG001|Baseline|Assisted Autogenic Drainage|20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
11190500|NCT02126748|BG002|Baseline|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
11190501|NCT02126748|BG003|Baseline|Total|Total of all reporting groups
11190502|NCT02126748|FG000|Participant Flow|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
11190503|NCT02126748|FG001|Participant Flow|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
11190504|NCT02126748|FG002|Participant Flow|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
11190505|NCT02126748|OG000|Outcome|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
11190506|NCT02126748|OG001|Outcome|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
11190507|NCT02126748|OG002|Outcome|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
11190508|NCT02126748|EG000|Reported Event|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
11190509|NCT02126748|EG001|Reported Event|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
11190510|NCT02126748|EG002|Reported Event|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
11190511|NCT02126826|BG000|Baseline|Placebo HV|Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190512|NCT02126826|BG001|Baseline|50mg BI 1026706 HV|Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190513|NCT02126826|BG002|Baseline|100mg BI 1026706 HV|Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190514|NCT02126826|BG003|Baseline|300mg BI 1026706 HV|Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190515|NCT02126826|BG004|Baseline|Placebo OA|Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190516|NCT02126826|BG005|Baseline|200mg BI 1026706 OA|Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190517|NCT02126826|BG006|Baseline|100mg BI 1026706 BID OA|Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12.
11190518|NCT02126826|BG007|Baseline|Total|Total of all reporting groups
11190519|NCT02126826|FG000|Participant Flow|Placebo HV|Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190520|NCT02126826|FG001|Participant Flow|50mg BI 1026706 HV|Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190521|NCT02126826|FG002|Participant Flow|100mg BI 1026706 HV|Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190522|NCT02126826|FG003|Participant Flow|300mg BI 1026706 HV|Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190523|NCT02126826|FG004|Participant Flow|Placebo OA|Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190524|NCT02126826|FG005|Participant Flow|200mg BI 1026706 OA|Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11376698|NCT02711137|FG003|Participant Flow|Part1/Treatment Group B : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
11190525|NCT02126826|FG006|Participant Flow|100mg BI 1026706 BID OA|Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12.
11190526|NCT02126826|OG000|Outcome|Placebo HV|Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190527|NCT02126826|OG001|Outcome|50mg BI 1026706 HV|Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190528|NCT02126826|OG002|Outcome|100mg BI 1026706 HV|Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190529|NCT02126826|OG003|Outcome|300mg BI 1026706 HV|Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190530|NCT02126826|OG004|Outcome|Placebo OA|Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190531|NCT02126826|OG005|Outcome|200mg BI 1026706 OA|Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190532|NCT02126826|OG006|Outcome|100mg BI 1026706 BID OA|Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12.
11190533|NCT02126826|OG000|Outcome|50mg BI 1026706 HV|Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190534|NCT02126826|OG001|Outcome|100mg BI 1026706 HV|Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190535|NCT02126826|OG002|Outcome|300mg BI 1026706 HV|Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190536|NCT02126826|OG003|Outcome|200mg BI 1026706 OA|Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190537|NCT02126826|OG004|Outcome|100mg BI 1026706 BID OA|Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12.
11190538|NCT02126826|EG000|Reported Event|Placebo HV|Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190539|NCT02126826|EG001|Reported Event|50mg BI 1026706 HV|Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190540|NCT02126826|EG002|Reported Event|100mg BI 1026706 HV|Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190541|NCT02126826|EG003|Reported Event|300mg BI 1026706 HV|Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190542|NCT02126826|EG004|Reported Event|Placebo OA|Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days.
11190543|NCT02126826|EG005|Reported Event|200mg BI 1026706 OA|Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
11190544|NCT02126826|EG006|Reported Event|100mg BI 1026706 BID OA|Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12.
11190545|NCT02126839|BG000|Baseline|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
11190546|NCT02126839|BG001|Baseline|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
11190547|NCT02126839|BG002|Baseline|Total|Total of all reporting groups
11372837|NCT02767570|BG000|Baseline|Gait Training; Altered Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.~Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks."
11372838|NCT02767570|BG001|Baseline|Gait Training; Consistent Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.~Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks."
11372839|NCT02767570|BG002|Baseline|Total|Total of all reporting groups
11372840|NCT02767570|FG000|Participant Flow|Gait Training; Altered Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.~Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks."
11372841|NCT02767570|FG001|Participant Flow|Gait Training; Consistent Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.~Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks."
11372842|NCT02767570|OG000|Outcome|Gait Training; Altered Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.~Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks."
11372843|NCT02767570|OG001|Outcome|Gait Training; Consistent Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.~Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks."
11372844|NCT02767570|EG000|Reported Event|Gait Training; Altered Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle.~Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks."
10850113|NCT00300391|BG001|Baseline|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
10850114|NCT00300391|BG002|Baseline|Total|Total of all reporting groups
10850115|NCT00300391|FG000|Participant Flow|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
10850116|NCT00300391|FG001|Participant Flow|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
10850117|NCT00300391|OG000|Outcome|Delirium|"Once diagnosed as delirious, randomized to haloperidol 5 mg IV~haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay."
10850118|NCT00300391|OG001|Outcome|Persistent Coma|
10850119|NCT00300391|OG002|Outcome|No Delirium|
10850120|NCT00300391|EG000|Reported Event|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
10850121|NCT00300391|EG001|Reported Event|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
10850122|NCT00300430|BG000|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
10850123|NCT00300430|BG001|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
10850124|NCT00300430|BG002|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
10850125|NCT00300430|BG003|Baseline|Total|Total of all reporting groups
10850126|NCT00300430|FG000|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
10850127|NCT00300430|FG001|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
10850128|NCT00300430|FG002|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
10850129|NCT00300430|OG000|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
10850130|NCT00300430|OG001|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
10850131|NCT00300430|OG002|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
10850132|NCT00300430|EG000|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
10850133|NCT00300430|EG001|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
10850134|NCT00300430|EG002|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
10850135|NCT00300456|BG000|Baseline|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
10850136|NCT00300456|BG001|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
10850137|NCT00300456|BG002|Baseline|ABT-335|ABT-335 monotherapy once daily
10850138|NCT00300456|BG003|Baseline|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
10850139|NCT00300456|BG004|Baseline|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
10850140|NCT00300456|BG005|Baseline|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
10850141|NCT00300456|BG006|Baseline|Total|Total of all reporting groups
10850142|NCT00300456|FG000|Participant Flow|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
10850143|NCT00300456|FG001|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
10850144|NCT00300456|FG002|Participant Flow|ABT-335|ABT-335 monotherapy once daily
10850145|NCT00300456|FG003|Participant Flow|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
10850146|NCT00300456|FG004|Participant Flow|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
10850147|NCT00300456|FG005|Participant Flow|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
10850148|NCT00300456|OG000|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
10850149|NCT00300456|OG001|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
10850150|NCT00300456|OG002|Outcome|ABT-335|ABT-335 monotherapy once daily
11372845|NCT02767570|EG001|Reported Event|Gait Training; Consistent Foot Progression Angle|"Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency.~Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks."
11372846|NCT02702180|BG000|Baseline|Molgramostim Once Daily|"Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372847|NCT02702180|BG001|Baseline|Molgramostim Intermittent|"Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372848|NCT02702180|BG002|Baseline|Placebo|"Inhalation of placebo nebuliser solution once daily for 24 weeks~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372849|NCT02702180|BG003|Baseline|Total|Total of all reporting groups
11372850|NCT02702180|FG000|Participant Flow|Molgramostim Once Daily|"Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372851|NCT02702180|FG001|Participant Flow|Molgramostim Intermittent|"Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372852|NCT02702180|FG002|Participant Flow|Placebo|"Inhalation of placebo nebuliser solution once daily for 24 weeks~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372853|NCT02702180|OG000|Outcome|Molgramostim Once Daily|"Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372854|NCT02702180|OG001|Outcome|Molgramostim Intermittent|"Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372855|NCT02702180|OG002|Outcome|Placebo|"Inhalation of placebo nebuliser solution once daily for 24 weeks~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372856|NCT02702180|EG000|Reported Event|Double-blind Molgramostim Once Daily|"Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372857|NCT02702180|EG001|Reported Event|Double-blind Molgramostim Intermittent|"Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11372858|NCT02702180|EG002|Reported Event|Double-blind Placebo|"Inhalation of placebo nebuliser solution once daily for 24 weeks~Placebo: Placebo nebulizer solution for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
10850151|NCT00300456|OG003|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
11372859|NCT02702180|EG003|Reported Event|Open-label Molgramostim Intermittent|"Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 or 48 weeks from completion of the double-blind period~Molgramostim: 300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation"
11372860|NCT02545049|BG000|Baseline|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11372861|NCT02545049|BG001|Baseline|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11372862|NCT02545049|BG002|Baseline|Total|Total of all reporting groups
10850152|NCT00300456|OG004|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
10850153|NCT00300456|OG005|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
11372863|NCT02545049|FG000|Participant Flow|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11372864|NCT02545049|FG001|Participant Flow|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11372865|NCT02545049|OG000|Outcome|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11372866|NCT02545049|OG001|Outcome|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11372867|NCT02545049|EG000|Reported Event|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11372868|NCT02545049|EG001|Reported Event|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11376699|NCT02711137|FG004|Participant Flow|Part1/Treatment Group B : 12mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
11376700|NCT02711137|FG005|Participant Flow|Part1/Treatment Group C : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
11372869|NCT02448381|BG000|Baseline|SGX301|"Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.~Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.~Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.~Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).~SGX301 (synthetic hypericin): 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372870|NCT02448381|BG001|Baseline|Placebo|"Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.~Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372871|NCT02448381|BG002|Baseline|Total|Total of all reporting groups
11372872|NCT02448381|FG000|Participant Flow|SGX301|"Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.~Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.~Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.~Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).~SGX301 (synthetic hypericin): 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372873|NCT02448381|FG001|Participant Flow|Placebo|"Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.~Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 18-24 hours, then treated with an initial dose of 12 J/cm^2 fluorescent light."
11372874|NCT02448381|OG000|Outcome|SGX301|"Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.~Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372875|NCT02448381|OG001|Outcome|Placebo|"Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.~Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372876|NCT02448381|OG000|Outcome|SGX301 (Cycle 1 & 2 = SGX301)|"Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.~Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.~Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372877|NCT02448381|OG001|Outcome|Placebo (Cycle 1)|"Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.~Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 12 J/cm^2 fluorescent light."
11372878|NCT02448381|OG000|Outcome|SGX301 (Cycle 1, 2 & 3 = SGX301)|"Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.~Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.~Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.~Cycle 3: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light."
11372879|NCT02448381|EG000|Reported Event|Cycle 1 - SGX301|Patients treated with SGX301 in Cycle 1.
11372880|NCT02448381|EG001|Reported Event|Cycle 1 - Placebo|Patients treated with Placebo in Cycle 1. Cycle 1 is the only cycle that used Placebo.
11372881|NCT02448381|EG002|Reported Event|Cycle 2 - SGX301|Patients treated with SGX301 in Cycle 2. Since all patients received SGX301 in Cycle 2, this includes 45 patients that received Placebo in Cycle 1 and 110 patients that continued to receive SGX301 in Cycle 2.
11372882|NCT02448381|EG003|Reported Event|Cycle 3 - SGX301|Patients treated with SGX301 in Cycle 3. Since all patients received SGX301 in Cycle 3, this includes 32 patients that received Placebo in Cycle 1 and 78 patients that continued to receive SGX301 in Cycle 3.
11372883|NCT02448381|EG004|Reported Event|Overall SGX301|Any participant that received at least one dose of SGX301 during any cycle of the trial.
11372884|NCT02151981|BG000|Baseline|Osimertinib 80 mg|Daily single dose of Osimertinib 80mg
11372885|NCT02151981|BG001|Baseline|Chemotherapy|Platinum-based doublet chemotherapy
11372886|NCT02151981|BG002|Baseline|Total|Total of all reporting groups
11372887|NCT02151981|FG000|Participant Flow|Osimertinib 80 mg|Daily single dose of Osimertinib 80mg
10850154|NCT00300456|EG000|Reported Event|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
10850155|NCT00300456|EG001|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
11240488|NCT02479802|BG000|Baseline|Albumin|"Plasma exchange with Albumin~Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:~three weeks of intensive treatment with two plasma exchanges per week~twenty-one weeks of maintenance treatment with one weekly plasma exchange"
11372888|NCT02151981|FG001|Participant Flow|Chemotherapy|Platinum-based doublet chemotherapy
11372889|NCT02151981|OG000|Outcome|Osimertinib 80mg|Daily single dose of Osimertinib 80mg
11372890|NCT02151981|OG001|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
11372891|NCT02151981|EG000|Reported Event|Osimertinib 80 mg|Daily single dose of Osimertinib 80mg
11372892|NCT02151981|EG001|Reported Event|Chemotherapy|Platinum-based doublet chemotherapy
11372893|NCT01972217|BG000|Baseline|Part A Cohort 1: Olaparib 200 mg + Abiraterone|"Patients received olaparib 200 mg bid and abiraterone 1000 mg once daily. Patients were assessed at Weeks 1, 2 and 4, then every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372894|NCT01972217|BG001|Baseline|Part A Cohort 2: Olaparib 300 mg + Abiraterone|"If the combination of olaparib 200 mg + abiraterone 1000 mg was well tolerated (determined after a minimum of 14 days treatment in Cohort 1), patients were recruited into Cohort 2.~Cohort 2 Group 1: patients received olaparib 300 mg bid alone for 3 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 5 days.~Cohort 2 Group 2: patients received abiraterone 1000 mg once daily alone for 5 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 3 days.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372895|NCT01972217|BG002|Baseline|Part B: Olaparib + Abiraterone|"Patients received the selected dose of olaparib 300 mg bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372896|NCT01972217|BG003|Baseline|Part B: Placebo + Abiraterone|"Patients received placebo bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372897|NCT01972217|BG004|Baseline|Total|Total of all reporting groups
11372898|NCT01972217|FG000|Participant Flow|Part A Cohort 1: Olaparib 200 mg + Abiraterone|"Patients received olaparib 200 milligrams (mg) twice daily (bid) and abiraterone 1000 mg once daily. Patients were assessed at Weeks 1, 2 and 4, then every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372899|NCT01972217|FG001|Participant Flow|Part A Cohort 2: Olaparib 300 mg + Abiraterone|"If the combination of olaparib 200 mg + abiraterone 1000 mg was well tolerated (determined after a minimum of 14 days treatment in Cohort 1), patients were recruited into Cohort 2.~Cohort 2 Group 1: patients received olaparib 300 mg bid alone for 3 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 5 days.~Cohort 2 Group 2: patients received abiraterone 1000 mg once daily alone for 5 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 3 days.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372900|NCT01972217|FG002|Participant Flow|Part B: Olaparib + Abiraterone|"Patients received the selected dose of olaparib 300 mg bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372901|NCT01972217|FG003|Participant Flow|Part B: Placebo + Abiraterone|"Patients received placebo bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372902|NCT01972217|OG000|Outcome|Part A Cohort 1: Olaparib 200 mg + Abiraterone|"Patients received olaparib 200 mg bid and abiraterone 1000 mg once daily. Patients were assessed at Weeks 1, 2 and 4, then every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372903|NCT01972217|OG001|Outcome|Part A Cohort 2: Olaparib 300 mg + Abiraterone|If the combination of olaparib 200 mg + abiraterone 1000 mg was well tolerated (determined after a minimum of 14 days treatment in Cohort 1), patients were recruited into Cohort 2. Cohort 2 Group 1: patients received olaparib 300 mg bid alone for 3 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 5 days. Cohort 2 Group 2: patients received abiraterone 1000 mg once daily alone for 5 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 3 days. Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment.
11372904|NCT01972217|OG000|Outcome|Part B: Olaparib + Abiraterone|"Patients received the selected dose of olaparib 300 mg bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372905|NCT01972217|OG001|Outcome|Part B: Placebo + Abiraterone|"Patients received placebo bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372906|NCT01972217|OG000|Outcome|Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone|"Patients received olaparib 300 mg bid alone for 3 to 7 days to determine the steady state PK profile for olaparib. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 5 days to determine the PK profiles of both olaparib and abiraterone.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
10850156|NCT00300456|EG002|Reported Event|ABT-335|ABT-335 monotherapy once daily
10850157|NCT00300456|EG003|Reported Event|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
11372907|NCT01972217|OG001|Outcome|Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone|"Patients received abiraterone 1000 mg once daily alone for 5 to 7 days to determine the steady state PK profile for abiraterone. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 3 days to determine the PK profiles of both olaparib and abiraterone.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372908|NCT01972217|EG000|Reported Event|Part A Cohort 1: Olaparib 200 mg + Abiraterone|"Patients received olaparib 200 mg bid and abiraterone 1000 mg once daily. Patients were assessed at Weeks 1, 2 and 4, then every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372909|NCT01972217|EG001|Reported Event|Part A Cohort 2: Olaparib 300 mg + Abiraterone|If the combination of olaparib 200 mg + abiraterone 1000 mg was well tolerated (determined after a minimum of 14 days treatment in Cohort 1), patients were recruited into Cohort 2. Cohort 2 Group 1: patients received olaparib 300 mg bid alone for 3 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 5 days. Cohort 2 Group 2: patients received abiraterone 1000 mg once daily alone for 5 to 7 days. Patients then received olaparib 300 mg bid and abiraterone 1000 mg once daily for at least 3 days. Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment.
11372910|NCT01972217|EG002|Reported Event|Part B: Olaparib + Abiraterone|"Patients received the selected dose of olaparib 300 mg bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372911|NCT01972217|EG003|Reported Event|Part B: Placebo + Abiraterone|"Patients received placebo bid + abiraterone 1000 mg once daily. Patients were assessed every 4 weeks up to Week 52, and every 12 weeks thereafter.~Patients also received prednisone or prednisolone 5 mg bid in combination with the abiraterone treatment."
11372912|NCT01849874|BG000|Baseline|MEK162|Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11372913|NCT01849874|BG001|Baseline|Physician's Choice|Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
11372914|NCT01849874|BG002|Baseline|Total|Total of all reporting groups
11372915|NCT01849874|FG000|Participant Flow|MEK162|Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11372916|NCT01849874|FG001|Participant Flow|Physician's Choice|Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
11372917|NCT01849874|OG000|Outcome|MEK162|Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11372918|NCT01849874|OG001|Outcome|Physician's Choice|Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
11372919|NCT01849874|EG000|Reported Event|MEK162|Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
11372920|NCT01849874|EG001|Reported Event|Physician's Choice|Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
11372921|NCT01724866|BG000|Baseline|Arm 1: SPI-2012 45 µg/kg and TC|"Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
10850158|NCT00300456|EG004|Reported Event|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
10850159|NCT00300456|EG005|Reported Event|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
10850160|NCT00300469|BG000|Baseline|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
11240489|NCT02479802|FG000|Participant Flow|Albumin|"Plasma exchange with Albumin~Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:~three weeks of intensive treatment with two plasma exchanges per week~twenty-one weeks of maintenance treatment with one weekly plasma exchange"
11240490|NCT02479802|OG000|Outcome|Albumin|"Plasma exchange with Albumin~Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:~three weeks of intensive treatment with two plasma exchanges per week~twenty-one weeks of maintenance treatment with one weekly plasma exchange"
11240491|NCT02479802|EG000|Reported Event|Albumin|"Plasma exchange with Albumin~Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:~three weeks of intensive treatment with two plasma exchanges per week~twenty-one weeks of maintenance treatment with one weekly plasma exchange"
11240492|NCT02479880|BG000|Baseline|Tenofovir DF + Increased Bone/Renal Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants were managed according to local standards of care.
11240493|NCT02479880|BG001|Baseline|Tenofovir DF + Prespecified Bone Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care.
11240494|NCT02479880|BG002|Baseline|Total|Total of all reporting groups
11240495|NCT02479880|FG000|Participant Flow|Tenofovir DF + Increased Bone/Renal Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body dual-energy x-ray absorptiometry (DXA) scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants were managed according to local standards of care.
11240496|NCT02479880|FG001|Participant Flow|Tenofovir DF + Prespecified Bone Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care.
11240497|NCT02479880|OG000|Outcome|Tenofovir DF + Increased Bone/Renal Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants were managed according to local standards of care.
11240498|NCT02479880|OG001|Outcome|Tenofovir DF + Prespecified Bone Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care.
11240499|NCT02479880|EG000|Reported Event|Tenofovir DF + Increased Bone/Renal Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants were managed according to local standards of care.
11240500|NCT02479880|EG001|Reported Event|Tenofovir DF + Prespecified Bone Monitoring|One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care.
11240501|NCT02480010|BG000|Baseline|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11240502|NCT02480010|BG001|Baseline|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11240503|NCT02480010|BG002|Baseline|Total|Total of all reporting groups
11240504|NCT02480010|FG000|Participant Flow|Pertuzumab 420 Milligrams (mg) - Cohort A|Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11240505|NCT02480010|FG001|Participant Flow|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11240506|NCT02480010|OG000|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11240507|NCT02480010|OG001|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11240508|NCT02480010|EG000|Reported Event|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11240509|NCT02480010|EG001|Reported Event|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
10850161|NCT00300469|BG001|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
10850162|NCT00300469|BG002|Baseline|ABT-335|ABT-335 monotherapy once daily
10850163|NCT00300469|BG003|Baseline|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
10850164|NCT00300469|BG004|Baseline|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
11190548|NCT02126839|FG000|Participant Flow|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
11372922|NCT01724866|BG001|Baseline|Arm 2: SPI-2012 135 µg/kg and TC|"Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372923|NCT01724866|BG002|Baseline|Arm 3: SPI-2012 270 µg/kg and TC|"Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372924|NCT01724866|BG003|Baseline|Arm 4: Pegfilgrastim and TC|"Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372925|NCT01724866|BG004|Baseline|Total|Total of all reporting groups
11372926|NCT01724866|FG000|Participant Flow|Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)|"Participants received SPI-2012 45 µg/kg, subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372927|NCT01724866|FG001|Participant Flow|Arm 2: SPI-2012 135 µg/kg and TC|"Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372928|NCT01724866|FG002|Participant Flow|Arm 3: SPI-2012 270 µg/kg and TC|"Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372929|NCT01724866|FG003|Participant Flow|Arm 4: Pegfilgrastim and TC|"Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372930|NCT01724866|OG000|Outcome|Arm 1: SPI-2012 45 µg/kg and TC|"Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372931|NCT01724866|OG001|Outcome|Arm 2: SPI-2012 135 µg/kg and TC|"Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372932|NCT01724866|OG002|Outcome|Arm 3: SPI-2012 270 µg/kg and TC|"Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372933|NCT01724866|OG003|Outcome|Arm 4: Pegfilgrastim and TC|"Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372934|NCT01724866|EG000|Reported Event|Arm 1: SPI-2012 45 µg/kg and TC|"Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372935|NCT01724866|EG001|Reported Event|Arm 2: SPI-2012 135 µg/kg and TC|"Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372936|NCT01724866|EG002|Reported Event|Arm 3: SPI-2012 270 µg/kg and TC|"Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11190549|NCT02126839|FG001|Participant Flow|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
11190550|NCT02126839|OG000|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
11337311|NCT03582553|FG004|Participant Flow|Cohort 2: NAR600, NAR900, Placebo|Cohort 2 Sequence 2: NAR600, then NAR900, and then Placebo. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
10850165|NCT00300469|BG005|Baseline|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
10850166|NCT00300469|BG006|Baseline|Total|Total of all reporting groups
10850167|NCT00300469|FG000|Participant Flow|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
10850168|NCT00300469|FG001|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
10850169|NCT00300469|FG002|Participant Flow|ABT-335|ABT-335 monotherapy once daily
10850170|NCT00300469|FG003|Participant Flow|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
11240510|NCT02480114|BG000|Baseline|Arm I Standard of Care|"Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.~Educational Intervention: Undergo oral care and pain management education session~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11341416|NCT03682107|FG004|Participant Flow|Placebo|"2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.~Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System"
11341417|NCT03682107|OG000|Outcome|2 mg ANDV, 3 Dose Regimen|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341418|NCT03682107|OG001|Outcome|2 mg ANDV, 4 Dose Regimen|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341419|NCT03682107|OG002|Outcome|4 mg ANDV, 3 Dose Regimen|4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341420|NCT03682107|OG003|Outcome|4 mg ANDV, 4 Dose Regimen|4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
10850171|NCT00300469|FG004|Participant Flow|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
10850172|NCT00300469|FG005|Participant Flow|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
11341421|NCT03682107|OG004|Outcome|Placebo|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
11341422|NCT03682107|EG000|Reported Event|2 mg ANDV, 3 Dose Regimen|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341423|NCT03682107|EG001|Reported Event|2 mg ANDV, 4 Dose Regimen|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341424|NCT03682107|EG002|Reported Event|4 mg ANDV, 3 Dose Regimen|4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341425|NCT03682107|EG003|Reported Event|4 mg ANDV, 4 Dose Regimen|4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
11341426|NCT03682107|EG004|Reported Event|Placebo|2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
11341427|NCT03682120|BG000|Baseline|3.75 mcg A/H7N9+MF59|3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11341428|NCT03682120|BG001|Baseline|7.5 mcg A/H7N9+MF59|7.5 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11341429|NCT03682120|BG002|Baseline|15 mcg A/H7N9+MF59|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11341430|NCT03682120|BG003|Baseline|15 mcg A/H7N9|15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
11341431|NCT03682120|BG004|Baseline|Total|Total of all reporting groups
11341432|NCT03682120|FG000|Participant Flow|3.75 mcg A/H7N9+MF59|"3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent inactivated, subunit influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).~MF59 adjuvant: Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11341433|NCT03682120|FG001|Participant Flow|7.5 mcg A/H7N9+MF59|"7.5 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent inactivated, subunit influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).~MF59 adjuvant: Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11341646|NCT03686033|FG000|Participant Flow|Sequence 1: Placebo + E2082 2.5 mg + E2082 25 mg + E2082 40 mg|Participants received, E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082 2.5 milligram (mg) (Treatment B) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between all the treatment periods.
10850173|NCT00300469|OG000|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
10850174|NCT00300469|OG001|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
10850175|NCT00300469|OG002|Outcome|ABT-335|ABT-335 monotherapy once daily
10850176|NCT00300469|OG003|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
10850177|NCT00300469|OG004|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
11372937|NCT01724866|EG003|Reported Event|Arm 4: Pegfilgrastim and TC|"Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:~Docetaxel 75 mg/m^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes."
11372938|NCT01670877|BG000|Baseline|Part I: Neratinib Only|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372939|NCT01670877|BG001|Baseline|Part II: Neratinib Only (ER-)|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372940|NCT01670877|BG002|Baseline|Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372941|NCT01670877|BG003|Baseline|Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372942|NCT01670877|BG004|Baseline|Total|Total of all reporting groups
11372943|NCT01670877|FG000|Participant Flow|Part I: Neratinib Only|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372944|NCT01670877|FG001|Participant Flow|Part II: Neratinib Only (ER-)|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372945|NCT01670877|FG002|Participant Flow|Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372946|NCT01670877|FG003|Participant Flow|Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372947|NCT01670877|FG004|Participant Flow|Crossover: Neratinib + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
11372948|NCT01670877|FG005|Participant Flow|Crossover: Neratinib + Fulvestrant + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
11372949|NCT01670877|OG000|Outcome|Part I: Neratinib Only|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372950|NCT01670877|OG001|Outcome|Part II: Neratinib Only (ER-)|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372951|NCT01670877|OG002|Outcome|Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372952|NCT01670877|OG003|Outcome|Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372953|NCT01670877|OG004|Outcome|Crossover: Neratinib + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
11372954|NCT01670877|OG005|Outcome|Crossover: Neratinib + Fulvestrant + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
11372955|NCT01670877|EG000|Reported Event|Part I: Neratinib Only|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372956|NCT01670877|EG001|Reported Event|Part II: Neratinib Only (ER-)|-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372957|NCT01670877|EG002|Reported Event|Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
11372958|NCT01670877|EG003|Reported Event|Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)|-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
10850178|NCT00300469|OG005|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
11240511|NCT02480114|BG001|Baseline|Arm II Standard of Care Plus Gabapentin|"Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.~Educational Intervention: Undergo oral care and pain management education session~Gabapentin: Given PO~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11372959|NCT01670877|EG004|Reported Event|Crossover: Neratinib + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
11372960|NCT01670877|EG005|Reported Event|Crossover: Neratinib + Fulvestrant + Trastuzumab|-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
11372961|NCT01602380|BG000|Baseline|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
11372962|NCT01602380|BG001|Baseline|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
11372963|NCT01602380|BG002|Baseline|Total|Total of all reporting groups
11372964|NCT01602380|FG000|Participant Flow|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
11372965|NCT01602380|FG001|Participant Flow|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
11372966|NCT01602380|OG000|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
11372967|NCT01602380|OG001|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
11372968|NCT01602380|EG000|Reported Event|Fulvestrant 500 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
11372969|NCT01602380|EG001|Reported Event|Anastrozole 1 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
11372970|NCT01412333|BG000|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372971|NCT01412333|BG001|Baseline|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372972|NCT01412333|BG002|Baseline|Total|Total of all reporting groups
11372973|NCT01412333|FG000|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372974|NCT01412333|FG001|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372975|NCT01412333|OG000|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372976|NCT01412333|OG001|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372977|NCT01412333|OG000|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372978|NCT01412333|EG000|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372979|NCT01412333|EG001|Reported Event|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372980|NCT01247324|BG000|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372981|NCT01247324|BG001|Baseline|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372982|NCT01247324|BG002|Baseline|Total|Total of all reporting groups
11372983|NCT01247324|FG000|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372984|NCT01247324|FG001|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372985|NCT01247324|OG000|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372986|NCT01247324|OG001|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372987|NCT01247324|OG000|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372988|NCT01247324|EG000|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
11372989|NCT01247324|EG001|Reported Event|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
11372990|NCT00667628|BG000|Baseline|Placebo|Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period. Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372991|NCT00667628|BG001|Baseline|TAC-101|Participants were administered with TAC-101 tablets, 20 mg/day orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372992|NCT00667628|BG002|Baseline|Total|Total of all reporting groups
11372993|NCT00667628|FG000|Participant Flow|Placebo|Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372994|NCT00667628|FG001|Participant Flow|TAC-101|Participants were administered with TAC-101 tablets, 20 milligrams per day (mg/day) orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372995|NCT00667628|OG000|Outcome|Placebo|Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372996|NCT00667628|OG001|Outcome|TAC-101|Participants were administered with TAC-101 tablets, 20 mg/day orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372997|NCT00667628|EG000|Reported Event|Placebo|Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11372998|NCT00667628|EG001|Reported Event|TAC-101|Participants were administered with TAC-101 tablets, 20 mg/day orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days up to new lesions were observed or the participant met a treatment discontinuation criterion.
11240512|NCT02480114|BG002|Baseline|Total|Total of all reporting groups
11376701|NCT02711137|FG006|Participant Flow|Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11337312|NCT03582553|FG005|Participant Flow|Cohort 2: Placebo, NAR600, NAR900|Cohort 2 Sequence 3: Placebo, NAR600, and then NAR300. 600 and 900 mg doses of naringenin where each 150 mg dose capsule (NAR150) contained 536 mg of the extract (28% naringenin determined in quantitative analysis). The 600 mg (NAR600) and 900 mg (NAR900) doses of naringenin were provided in four and six 150 mg capsules respectively. The placebo capsules contained microcystalline cellulose and were similar in appearance.
10850179|NCT00300469|EG000|Reported Event|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
11337313|NCT03582553|OG000|Outcome|150 mg Dose|Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11372999|NCT04286529|BG000|Baseline|Men-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373000|NCT04286529|BG001|Baseline|Premenopausal Women-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
10850180|NCT00300469|EG001|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
10850181|NCT00300469|EG002|Reported Event|ABT-335|ABT-335 monotherapy once daily
11337314|NCT03582553|OG001|Outcome|300 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337315|NCT03582553|OG002|Outcome|600 mg Dose|Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337316|NCT03582553|OG003|Outcome|900 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
11337317|NCT03582553|OG004|Outcome|Placebo|Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
11337318|NCT03582553|OG000|Outcome|150 mg Dose|"Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.~Naringenin: An extract of Citrus Sinensis containing naringenin and its precursor naringin"
11337319|NCT03582553|OG001|Outcome|600 mg Dose|"Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.~Naringenin: An extract of Citrus Sinensis containing naringenin and its precursor naringin"
11337320|NCT03582553|OG002|Outcome|Placebo|"Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.~Placebo: Cellulose"
11337321|NCT03582553|OG000|Outcome|300 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337322|NCT03582553|OG001|Outcome|900 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
11337323|NCT03582553|OG002|Outcome|Placebo|Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
11337324|NCT03582553|EG000|Reported Event|150 mg Dose|Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337325|NCT03582553|EG001|Reported Event|300 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337326|NCT03582553|EG002|Reported Event|600 mg Dose|Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin
11337327|NCT03582553|EG003|Reported Event|900 mg Dose|Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing 28% naringenin.
11337328|NCT03582553|EG004|Reported Event|Placebo|Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.
11337329|NCT03582813|BG000|Baseline|Self-directed Care|"Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods..~Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system"
11337330|NCT03582813|BG001|Baseline|Services as Usual|"Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.~Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency"
11337331|NCT03582813|BG002|Baseline|Total|Total of all reporting groups
11373001|NCT04286529|BG002|Baseline|Men-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373002|NCT04286529|BG003|Baseline|Premenopausal Women-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373003|NCT04286529|BG004|Baseline|Total|Total of all reporting groups
11373004|NCT04286529|FG000|Participant Flow|Men-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373005|NCT04286529|FG001|Participant Flow|Premenopausal Women-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373006|NCT04286529|FG002|Participant Flow|Men-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373007|NCT04286529|FG003|Participant Flow|Premenopausal Women-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373008|NCT04286529|OG000|Outcome|Men-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373009|NCT04286529|OG001|Outcome|Premenopausal Women-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373010|NCT04286529|OG002|Outcome|Men-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373011|NCT04286529|OG003|Outcome|Premenopausal Women-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373012|NCT04286529|EG000|Reported Event|Men-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373013|NCT04286529|EG001|Reported Event|Premenopausal Women-Calcitriol|"Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.~Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally"
11373014|NCT04286529|EG002|Reported Event|Men-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373015|NCT04286529|EG003|Reported Event|Premenopausal Women-Placebo|"0.25mcg capsule daily for eight weeks~Oral Placebo: Placebo will be created to mimic the appearance of the study drug"
11373016|NCT03581786|BG000|Baseline|Placebo Combine With Chemotherapy|Placebos: placebo combine with chemotherapy
11373017|NCT03581786|BG001|Baseline|TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
11373018|NCT03581786|BG002|Baseline|Total|Total of all reporting groups
11373019|NCT03581786|FG000|Participant Flow|Placebo Combine With Chemotherapy|In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 & 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles.During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
11373020|NCT03581786|FG001|Participant Flow|TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy|"In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 & 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles .~During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years."
11373021|NCT03581786|OG000|Outcome|Placebo Combine With Chemotherapy|Placebos: placebo combine with chemotherapy
11373022|NCT03581786|OG001|Outcome|TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
11373023|NCT03581786|EG000|Reported Event|Placebo Combine With Chemotherapy|Placebos: placebo combine with chemotherapy
11373024|NCT03581786|EG001|Reported Event|TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
11373025|NCT03573518|BG000|Baseline|BTX 1503 5% BID|BTX 1503 5% CBD (w/w) solution twice daily
11373026|NCT03573518|BG001|Baseline|BTX 1503 5% QD|BTX 1503 5% CBD (w/w) solution once daily
11373027|NCT03573518|BG002|Baseline|BTX 1503 2.5% QD|BTX 1503 2.5% CBD (w/w) solution once daily
11373028|NCT03573518|BG003|Baseline|Vehicle Combined (BID or QID)|"Placebo BID + Placebo QD~=Placebo Combined group"
11373029|NCT03573518|BG004|Baseline|Total|Total of all reporting groups
11373030|NCT03573518|FG000|Participant Flow|BTX 1503 5% BID|BTX 1503 5% CBD (w/w) solution twice daily
11373031|NCT03573518|FG001|Participant Flow|BTX 1503 5% QD|BTX 1503 5% CBD (w/w) solution once daily
11373032|NCT03573518|FG002|Participant Flow|BTX 1503 2.5% QD|BTX 1503 2.5% CBD (w/w) solution once daily
11373033|NCT03573518|FG003|Participant Flow|Vehicle Combined (BID or QID)|"Placebo BID + Placebo QD~=Placebo Combined group"
11373034|NCT03573518|OG000|Outcome|BTX 1503 5% BID|BTX 1503 5% CBD (w/w) solution twice daily
11373035|NCT03573518|OG001|Outcome|BTX 1503 5% QD|BTX 1503 5% CBD (w/w) solution once daily
11373036|NCT03573518|OG002|Outcome|BTX 1503 2.5% QD|BTX 1503 2.5% CBD (w/w) solution once daily
11373037|NCT03573518|OG003|Outcome|Vehicle Combined (BID or QID)|"Placebo BID + Placebo QD~=Placebo Combined group"
11373038|NCT03573518|EG000|Reported Event|BTX 1503 5% BID|BTX 1503 5% CBD (w/w) solution twice daily
11373039|NCT03573518|EG001|Reported Event|BTX 1503 5% QD|BTX 1503 5% CBD (w/w) solution once daily
11373040|NCT03573518|EG002|Reported Event|BTX 1503 2.5% QD|BTX 1503 2.5% CBD (w/w) solution once daily
11373041|NCT03573518|EG003|Reported Event|Vehicle Combined (BID or QID)|"Placebo BID + Placebo QD~=Placebo Combined group"
11373042|NCT03486314|BG000|Baseline|Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg|Pevonedistat 50 mg/m^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
11373043|NCT03486314|FG000|Participant Flow|Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg|Pevonedistat 50 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1 and 10, and then rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
11373044|NCT03486314|FG001|Participant Flow|Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2|Pevonedistat 25 mg/m^2, infusion, intravenously in combination with docetaxel 75 mg/m^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373045|NCT03486314|FG002|Participant Flow|Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2|Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 milligram* minute per milliliter (mg*min/mL), infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373046|NCT03486314|OG000|Outcome|Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg|Pevonedistat 50 mg/m^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
11373047|NCT03486314|OG000|Outcome|Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2|Pevonedistat 25 mg/m^2, infusion, intravenously in combination with docetaxel 75 mg/m^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373048|NCT03486314|OG001|Outcome|Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5 + Paclitaxel 175 mg/m^2|Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg*min/mL, infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373049|NCT03486314|EG000|Reported Event|Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg|Pevonedistat 50 mg/m^2, infusion, intravenously, once on Days 1 and 10, and then rifampin 600 mg, capsule, orally, once daily from Day 3 up to Day 11 in Part A. Pevonedistat was not administered from Day 2 through Day 9.
11373050|NCT03486314|EG001|Reported Event|Part B: Pevonedistat 25 mg/m^2 + Docetaxel 75 mg/m^2|Pevonedistat 25 mg/m^2, infusion, intravenously in combination with docetaxel 75 mg/m^2, infusion, intravenously on Day 1 of 21-day cycle, followed by pevonedistat 25 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment discontinuation for another reason, or until the study was stopped in Part B. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373051|NCT03486314|EG002|Reported Event|Part B: Pevonedistat 20 mg/m^2 + Carboplatin AUC5+ Paclitaxel 175 mg/m^2|Pevonedistat 20 mg/m^2, infusion, intravenously in combination with carboplatin AUC at the dose of 5 mg*min/mL, infusion, intravenously and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle, followed by pevonedistat 20 mg/m^2, infusion, intravenously alone once on Days 3 and 5 in each 21-day cycle for up to 17 cycles or symptomatic deterioration or disease progression, treatment was discontinued for another reason, or until the study was stopped in Part B. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11373052|NCT02988713|BG000|Baseline|Spinal Cord Stimulation|"Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial"
11373053|NCT02988713|FG000|Participant Flow|Spinal Cord Stimulation|"Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial"
11373054|NCT02988713|OG000|Outcome|Spinal Cord Stimulation|"Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial"
11373055|NCT02988713|EG000|Reported Event|Spinal Cord Stimulation|"Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial"
11373056|NCT02794883|BG000|Baseline|Arm 1: Tremelimumab Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.~Post-surgical MRI of brain will be done 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks."
10850182|NCT00300469|EG003|Reported Event|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
10850183|NCT00300469|EG004|Reported Event|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
10850184|NCT00300469|EG005|Reported Event|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
11190551|NCT02126839|OG001|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
11190552|NCT02126839|EG000|Reported Event|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
11190553|NCT02126839|EG001|Reported Event|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
11190554|NCT02126969|BG000|Baseline|Chemotherapy Plus Radiation Therapy|"Low dose fractionated radiation - 80cGy with chemotherapy~Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT"
11190555|NCT02126969|BG001|Baseline|Chemotherapy Without Radiation|"Chemotherapy only~Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation"
11190556|NCT02126969|BG002|Baseline|Total|Total of all reporting groups
11190557|NCT02126969|FG000|Participant Flow|Chemotherapy Plus Radiation Therapy|"Low dose fractionated radiation - 80cGy with chemotherapy~Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT"
11190558|NCT02126969|FG001|Participant Flow|Chemotherapy Without Radiation|"Chemotherapy only~Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation"
11190559|NCT02126969|OG000|Outcome|Chemotherapy Plus Radiation Therapy|"Low dose fractionated radiation - 80cGy with chemotherapy~Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT"
11190560|NCT02126969|OG001|Outcome|Chemotherapy Without Radiation|"Chemotherapy only~Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation"
11190561|NCT02126969|EG000|Reported Event|Chemotherapy Plus Radiation Therapy|"Low dose fractionated radiation - 80cGy with chemotherapy~Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT"
11190562|NCT02126969|EG001|Reported Event|Chemotherapy Without Radiation|"Chemotherapy only~Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation"
11190563|NCT02127125|BG000|Baseline|Lean With NGT-Placebo|Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190564|NCT02127125|BG001|Baseline|Lean With NGT-Sevelamer|Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190565|NCT02127125|BG002|Baseline|Lean With NGT-Synbiotic|Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190566|NCT02127125|BG003|Baseline|Obese With NGT-Placebo|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190567|NCT02127125|BG004|Baseline|Obese With NGT-Sevelamer|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190568|NCT02127125|BG005|Baseline|Obese With NGT-Synbiotic|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190569|NCT02127125|BG006|Baseline|Type 2 Diabetes-Placebo|Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190570|NCT02127125|BG007|Baseline|Type 2 Diabetes-Sevelamer|Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190571|NCT02127125|BG008|Baseline|Type 2 Diabetes-Synbiotic|Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190572|NCT02127125|BG009|Baseline|Total|Total of all reporting groups
11190573|NCT02127125|FG000|Participant Flow|Lean With NGT-Placebo|Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190574|NCT02127125|FG001|Participant Flow|Lean With NGT-Sevelamer|Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190575|NCT02127125|FG002|Participant Flow|Lean With NGT-Synbiotic|Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190576|NCT02127125|FG003|Participant Flow|Obese With NGT-Placebo|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
10850185|NCT00300482|BG000|Baseline|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
10850186|NCT00300482|BG001|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
10850187|NCT00300482|BG002|Baseline|ABT-335|ABT-335 monotherapy once daily
10850188|NCT00300482|BG003|Baseline|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
10850189|NCT00300482|BG004|Baseline|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
10850190|NCT00300482|BG005|Baseline|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
10850191|NCT00300482|BG006|Baseline|Total|Total of all reporting groups
10850192|NCT00300482|FG000|Participant Flow|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
10850193|NCT00300482|FG001|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
10850194|NCT00300482|FG002|Participant Flow|ABT-335|ABT-335 monotherapy once daily
10850195|NCT00300482|FG003|Participant Flow|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
10850196|NCT00300482|FG004|Participant Flow|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
10850197|NCT00300482|FG005|Participant Flow|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
11341647|NCT03686033|FG001|Participant Flow|Sequence 2: E2082 2.5 mg + E2082 25 mg + Placebo + E2082 40 mg|Participants received, E2082 2.5 mg (Treatment B) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between the treatment periods.
10850198|NCT00300482|OG000|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
11341648|NCT03686033|FG002|Participant Flow|Sequence 3: E2082 25 mg + Placebo + E2082 2.5 mg + E2082 40 mg|Participants received, E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082 2.5 mg (Treatment B) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between the treatment periods.
10850199|NCT00300482|OG001|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
10850200|NCT00300482|OG002|Outcome|ABT-335|ABT-335 monotherapy once daily
10850201|NCT00300482|OG003|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
10850202|NCT00300482|OG004|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
10962855|NCT00868751|OG000|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
11190577|NCT02127125|FG004|Participant Flow|Obese With NGT-Sevelamer|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11373057|NCT02794883|BG001|Baseline|Arm 2: MEDI4736 Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
10850203|NCT00300482|OG005|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
11190578|NCT02127125|FG005|Participant Flow|Obese With NGT-Synbiotic|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190579|NCT02127125|FG006|Participant Flow|Type 2 Diabetes -Placebo|Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190580|NCT02127125|FG007|Participant Flow|Type 2 Diabetes-Sevelamer|Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190581|NCT02127125|FG008|Participant Flow|Type 2 Diabetes-Synbiotic|Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190582|NCT02127125|OG000|Outcome|Lean With NGT-Placebo|Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
11190583|NCT02127125|OG001|Outcome|Lean With NGT-Sevelamer|Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
10850204|NCT00300482|EG000|Reported Event|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
10850205|NCT00300482|EG001|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
10850206|NCT00300482|EG002|Reported Event|ABT-335|ABT-335 monotherapy once daily
11190584|NCT02127125|OG002|Outcome|Lean With NGT-Synbiotic|Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11240513|NCT02480114|FG000|Participant Flow|Arm II Standard of Care Plus Gabapentin|"Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.~Educational Intervention: Undergo oral care and pain management education session~Gabapentin: Given PO~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
10850207|NCT00300482|EG003|Reported Event|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
10850208|NCT00300482|EG004|Reported Event|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
10850209|NCT00300482|EG005|Reported Event|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
10850210|NCT00300495|BG000|Baseline|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered"
10850211|NCT00300495|BG001|Baseline|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
10850212|NCT00300495|BG002|Baseline|Total|Total of all reporting groups
10850213|NCT00300495|FG000|Participant Flow|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
11240514|NCT02480114|FG001|Participant Flow|Arm I Standard of Care|Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.
10850214|NCT00300495|FG001|Participant Flow|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
10850215|NCT00300495|OG000|Outcome|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
11376702|NCT02711137|FG007|Participant Flow|Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11190585|NCT02127125|OG003|Outcome|Obese With NGT-Placebo|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190586|NCT02127125|OG004|Outcome|Obese With NGT-Sevelamer|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190587|NCT02127125|OG005|Outcome|Obese With NGT-Synbiotic|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190588|NCT02127125|OG006|Outcome|Type 2 Diabetes-Placebo|Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190589|NCT02127125|OG007|Outcome|Type 2 Diabetes-Sevelamer|Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190590|NCT02127125|OG008|Outcome|Type 2 Diabetes-Synbiotic|Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190591|NCT02127125|EG000|Reported Event|Lean With NGT-Placebo|Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
11190592|NCT02127125|EG001|Reported Event|Lean With NGT-Sevelamer|Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190593|NCT02127125|EG002|Reported Event|Lean With NGT-Synbiotic|Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190594|NCT02127125|EG003|Reported Event|Obese With NGT-Placebo|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190595|NCT02127125|EG004|Reported Event|Obese With NGT-Sevelamer|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190596|NCT02127125|EG005|Reported Event|Obese With NGT-Synbiotic|Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190597|NCT02127125|EG006|Reported Event|Type 2 Diabetes-Placebo|Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
11190598|NCT02127125|EG007|Reported Event|Type 2 Diabetes-Sevelamer|Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
11190599|NCT02127125|EG008|Reported Event|Type 2 Diabetes-Synbiotic|Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
11190600|NCT02127281|BG000|Baseline|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
11373058|NCT02794883|BG002|Baseline|Arm 3: Tremelimumab + MEDI4736|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).~Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.~On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373059|NCT02794883|BG003|Baseline|Total|Total of all reporting groups
11373060|NCT02794883|FG000|Participant Flow|Arm 1: Tremelimumab Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.~Post-surgical MRI of brain will be done 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks."
11373061|NCT02794883|FG001|Participant Flow|Arm 2: MEDI4736 Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373062|NCT02794883|FG002|Participant Flow|Arm 3: Tremelimumab + MEDI4736|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).~Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.~On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373063|NCT02794883|OG000|Outcome|Arm 1: Tremelimumab Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.~Post-surgical MRI of brain will be done 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks."
11373064|NCT02794883|OG001|Outcome|Arm 2: MEDI4736 Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373065|NCT02794883|OG002|Outcome|Arm 3: Tremelimumab + MEDI4736|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).~Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.~On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373066|NCT02794883|EG000|Reported Event|Arm 1: Tremelimumab Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.~Post-surgical MRI of brain will be done 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks."
11373067|NCT02794883|EG001|Reported Event|Arm 2: MEDI4736 Only|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373068|NCT02794883|EG002|Reported Event|Arm 3: Tremelimumab + MEDI4736|"Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV~Post-surgical MRI of brain will be done within 72 hours after surgery.~Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).~Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.~On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.~Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks"
11373069|NCT02677987|BG000|Baseline|Intervention Light|"30 minutes of intervention systematic light exposure daily for 4 weeks.~Intervention systematic light exposure: Bright light using Litebook device."
11373070|NCT02677987|BG001|Baseline|Comparison Light|"30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373071|NCT02677987|BG002|Baseline|Total|Total of all reporting groups
11373072|NCT02677987|FG000|Participant Flow|Intervention Light|"30 minutes of intervention systematic light exposure daily for 4 weeks.~Intervention systematic light exposure: Bright light using Litebook device."
11373073|NCT02677987|FG001|Participant Flow|Comparison Light|"30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373074|NCT02677987|OG000|Outcome|Intervention Light|"30 minutes of intervention systematic light exposure daily for 4 weeks.~Intervention systematic light exposure: Bright light using Litebook device."
11373075|NCT02677987|OG001|Outcome|Comparison Light|"30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373076|NCT02677987|OG000|Outcome|Comparison Light|"30 minutes of comparison systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373077|NCT02677987|OG001|Outcome|Intervention Light|"30 minutes of intervention systematic light exposure daily for 4 weeks.~Intervention systematic light exposure: Bright light using Litebook device."
11373078|NCT02677987|OG000|Outcome|Comparison Light|"30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373079|NCT02677987|OG001|Outcome|Comparison Light|"30 minutes of comparison systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373080|NCT02677987|EG000|Reported Event|Intervention Light|"30 minutes of intervention systematic light exposure daily for 4 weeks.~Intervention systematic light exposure: Bright light using Litebook device."
11373081|NCT02677987|EG001|Reported Event|Comparison Light|"30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.~Comparison systematic light exposure: Dim light using modified Litebook device."
11373082|NCT02659059|BG000|Baseline|Nivolumab+Ipilimumab|Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W
11373083|NCT02659059|BG001|Baseline|Nivolumab+Ipilimumab+Chemotherapy|Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy
11373084|NCT02659059|BG002|Baseline|Total|Total of all reporting groups
11373085|NCT02659059|FG000|Participant Flow|Nivolumab+Ipilimumab|Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W
11373086|NCT02659059|FG001|Participant Flow|Nivolumab+Ipilimumab+Chemotherapy|Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy
11373087|NCT02659059|OG000|Outcome|Nivolumab+Ipilimumab|Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W
11373088|NCT02659059|OG000|Outcome|Nivolumab+Ipilimumab+Chemotherapy|Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy
11373089|NCT02659059|OG001|Outcome|Nivolumab+Ipilimumab+Chemotherapy|Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy
11373090|NCT02659059|EG000|Reported Event|Nivolumab+Ipilimumab|Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W
11373091|NCT02659059|EG001|Reported Event|Nivolumab+Ipilimumab+Chemotherapy|Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy
11373092|NCT02337829|BG000|Baseline|Acalabrutinib 100 mg BID Relapse/Refractory|relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
11373093|NCT02337829|BG001|Baseline|Acalabrutinib 200 mg QD Relapse/Refractory|Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
11373094|NCT02337829|BG002|Baseline|Acalabrutinib 100 mg BID Treatment Naive|Treatment naive subjects treated with acalabrutinib 100 mg twice a day
11373095|NCT02337829|BG003|Baseline|Acalabrutinib 200 mg QD Treatment Naive|Treatment naive subjects treated with acalabrutinib 200 mg once a day
11373096|NCT02337829|BG004|Baseline|Total|Total of all reporting groups
11373097|NCT02337829|FG000|Participant Flow|Acalabrutinib 100 mg BID Relapse/Refractory|relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
11373098|NCT02337829|FG001|Participant Flow|Acalabrutinib 200 mg QD Relapse/Refractory|Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
11373099|NCT02337829|FG002|Participant Flow|Acalabrutinib 100 mg BID Treatment Naive|Treatment naive subjects treated with acalabrutinib 100 mg twice a day
11373100|NCT02337829|FG003|Participant Flow|Acalabrutinib 200 mg QD Treatment Naive|Treatment naive subjects treated with acalabrutinib 200 mg once a day
11373101|NCT02337829|OG000|Outcome|Acalabrutinib 100 mg BID Relapse/Refractory|relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
11373102|NCT02337829|OG001|Outcome|Acalabrutinib 200 mg QD Relapse/Refractory|Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
11373103|NCT02337829|OG002|Outcome|Total Relapse/Refractory Subjects|All relapse/refractory subjects in both dose groups combined
11373104|NCT02337829|OG003|Outcome|Acalabrutinib 100 mg BID Treatment Naive|Treatment naive subjects treated with acalabrutinib 100 mg twice a day
11373105|NCT02337829|OG004|Outcome|Acalabrutinib 200 mg QD Treatment Naive|Treatment naive subjects treated with acalabrutinib 200 mg once a day
11373106|NCT02337829|OG005|Outcome|Total Treatment Naive Subjects|All treatment naive subjects in both dose groups combined
11373107|NCT02337829|EG000|Reported Event|Acalabrutinib 100 mg BID Relapse/Refractory|relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
11373108|NCT02337829|EG001|Reported Event|Acalabrutinib 200 mg QD Relapse/Refractory|Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
11373109|NCT02337829|EG002|Reported Event|Acalabrutinib 100 mg BID Treatment Naive|Treatment naive subjects treated with acalabrutinib 100 mg twice a day
11373110|NCT02337829|EG003|Reported Event|Acalabrutinib 200 mg QD Treatment Naive|Treatment naive subjects treated with acalabrutinib 200 mg once a day
11373111|NCT01928394|BG000|Baseline|TNBC Arm N|Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
11373112|NCT01928394|BG001|Baseline|TNBC Arm N-I Dose Level 1|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373113|NCT01928394|BG002|Baseline|TNBC Arm N-I Dose Level 2|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373114|NCT01928394|BG003|Baseline|GC Arm N|Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
11373115|NCT01928394|BG004|Baseline|GC Arm N-I Dose Level 1|Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373116|NCT01928394|BG005|Baseline|GC Arm N-I Dose Level 2|Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
11190601|NCT02127281|BG001|Baseline|Control|A standard of care sterile wound dressing will be placed.
11190602|NCT02127281|BG002|Baseline|Total|Total of all reporting groups
11190603|NCT02127281|FG000|Participant Flow|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
11190604|NCT02127281|FG001|Participant Flow|Control|A standard of care sterile wound dressing will be placed.
11373117|NCT01928394|BG006|Baseline|GC Arm N-I Dose Level 2b|Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373118|NCT01928394|BG007|Baseline|PC Arm N|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
11190605|NCT02127281|OG000|Outcome|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
11190606|NCT02127281|OG001|Outcome|Control|A standard of care sterile wound dressing will be placed.
11190607|NCT02127281|EG000|Reported Event|Prevena|"Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).~Prevena: Device will be applied at end of procedure over closed incision."
11190608|NCT02127281|EG001|Reported Event|Control|A standard of care sterile wound dressing will be placed.
11190609|NCT02127307|BG000|Baseline|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
11190610|NCT02127307|FG000|Participant Flow|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
11190611|NCT02127307|OG000|Outcome|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
11190612|NCT02127307|EG000|Reported Event|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
11190613|NCT02127372|BG000|Baseline|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
11190614|NCT02127372|BG001|Baseline|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
11190615|NCT02127372|BG002|Baseline|Total|Total of all reporting groups
11373119|NCT01928394|BG008|Baseline|PC Arm N-I Dose Level 1|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373120|NCT01928394|BG009|Baseline|PC Arm N-I Dose Level 2|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373121|NCT01928394|BG010|Baseline|PC Arm N-I Dose Level 2d|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
11373122|NCT01928394|BG011|Baseline|SCLC Arm N - Pre-expansion|Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W
11373123|NCT01928394|BG012|Baseline|SCLC Arm N-I Dose Level 2 - Pre-expansion|Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373124|NCT01928394|BG013|Baseline|SCLC Arm N Expansion|Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W
11373125|NCT01928394|BG014|Baseline|SCLC Arm N-I Dose Level 2- Expansion|Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi
11373126|NCT01928394|BG015|Baseline|SCLC Arm N-I Dose Level 1 -|Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W
11373127|NCT01928394|BG016|Baseline|SCLC Arm N-I Dose Level 2b|Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373128|NCT01928394|BG017|Baseline|BC Arm N|Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W
11373129|NCT01928394|BG018|Baseline|BC Arm N-I Dose Level 2|Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373130|NCT01928394|BG019|Baseline|BC Arm N-I Dose Level 2b|Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373131|NCT01928394|BG020|Baseline|OC Arm N-I Dose Level 2|"Ovarian cancer (OC) participants:~Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W"
11373132|NCT01928394|BG021|Baseline|OC Arm N-I Dose Level 2b:|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W
11373133|NCT01928394|BG022|Baseline|OC Arm N-I Dose Level 2c:|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W
11373134|NCT01928394|BG023|Baseline|Total|Total of all reporting groups
11373135|NCT01928394|FG000|Participant Flow|TNBC Arm N|Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
11373136|NCT01928394|FG001|Participant Flow|TNBC Arm N-I Dose Level 1|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373137|NCT01928394|FG002|Participant Flow|TNBC Arm N-I Dose Level 2|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373138|NCT01928394|FG003|Participant Flow|GC Arm N|Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
11373139|NCT01928394|FG004|Participant Flow|GC Arm N-I Dose Level 1|Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373140|NCT01928394|FG005|Participant Flow|GC Arm N-I Dose Level 2|Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
11373141|NCT01928394|FG006|Participant Flow|GC Arm N-I Dose Level 2b|Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373142|NCT01928394|FG007|Participant Flow|PC Arm N|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
11373143|NCT01928394|FG008|Participant Flow|PC Arm N-I Dose Level 1|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373144|NCT01928394|FG009|Participant Flow|PC Arm N-I Dose Level 2|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373145|NCT01928394|FG010|Participant Flow|PC Arm N-I Dose Level 2d|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
11373146|NCT01928394|FG011|Participant Flow|SCLC Arm N - Pre-expansion|Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W
11373147|NCT01928394|FG012|Participant Flow|SCLC Arm N-I Dose Level 2 - Pre-expansion|Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373148|NCT01928394|FG013|Participant Flow|SCLC Arm N Expansion|Small cell lung cancer (SCLC) expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W
11373149|NCT01928394|FG014|Participant Flow|SCLC Arm N-I Dose Level 2- Expansion|Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373150|NCT01928394|FG015|Participant Flow|SCLC Arm N-I Dose Level 1 -|Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W
11373151|NCT01928394|FG016|Participant Flow|SCLC Arm N-I Dose Level 2b|Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373152|NCT01928394|FG017|Participant Flow|BC Arm N|Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W
11373153|NCT01928394|FG018|Participant Flow|BC Arm N-I Dose Level 2|Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373154|NCT01928394|FG019|Participant Flow|BC Arm N-I Dose Level 2b|Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373155|NCT01928394|FG020|Participant Flow|OC Arm N-I Dose Level 2|"Ovarian cancer (OC) participants:~Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W"
10850216|NCT00300495|OG001|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
11190616|NCT02127372|FG000|Participant Flow|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
10850217|NCT00300495|EG000|Reported Event|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
11190617|NCT02127372|FG001|Participant Flow|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
11373156|NCT01928394|FG021|Participant Flow|OC Arm N-I Dose Level 2b|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W
11373157|NCT01928394|FG022|Participant Flow|OC Arm N-I Dose Level 2c:|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W
11373158|NCT01928394|OG000|Outcome|TNBC Arm N|Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
11373159|NCT01928394|OG001|Outcome|TNBC Arm N-I Dose Level 1|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373160|NCT01928394|OG002|Outcome|TNBC Arm N-I Dose Level 2|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373161|NCT01928394|OG003|Outcome|GC Arm N|Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
11373162|NCT01928394|OG004|Outcome|GC Arm N-I Dose Level 1|Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373163|NCT01928394|OG005|Outcome|GC Arm N-I Dose Level 2|Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
11373164|NCT01928394|OG006|Outcome|GC Arm N-I Dose Level 2b|Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373165|NCT01928394|OG007|Outcome|PC Arm N|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
11373166|NCT01928394|OG008|Outcome|PC Arm N-I Dose Level 1|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373167|NCT01928394|OG009|Outcome|PC Arm N-I Dose Level 2|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373168|NCT01928394|OG010|Outcome|PC Arm N-I Dose Level 2d|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
11373169|NCT01928394|OG011|Outcome|SCLC Arm N - Pre-expansion|Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W
11373170|NCT01928394|OG012|Outcome|SCLC Arm N-I Dose Level 2 - Pre-expansion|Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373171|NCT01928394|OG013|Outcome|SCLC Arm N Expansion|Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W
11373172|NCT01928394|OG014|Outcome|SCLC Arm N-I Dose Level 2- Expansion|Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi
11373173|NCT01928394|OG015|Outcome|SCLC Arm N-I Dose Level 1 -|Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W
11373174|NCT01928394|OG016|Outcome|SCLC Arm N-I Dose Level 2b|Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373175|NCT01928394|OG017|Outcome|SCLC Arm N- All Treated|Small cell lung cancer (SCLC) for all treated participants with Nivolumab 3 mg/kg Q2W
11373176|NCT01928394|OG018|Outcome|SCLC Arm N-I Dose Level 2 - All Treated|Small cell lung cancer (SCLC) all treated participants with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses
11373177|NCT01928394|OG019|Outcome|BC Arm N|Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W
11373178|NCT01928394|OG020|Outcome|BC Arm N-I Dose Level 2|Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373179|NCT01928394|OG021|Outcome|BC Arm N-I Dose Level 2b|Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373180|NCT01928394|OG022|Outcome|OC Arm N-I Dose Level 2|"Ovarian cancer (OC) participants:~Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W"
11373181|NCT01928394|OG023|Outcome|OC Arm N-I Dose Level 2b:|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W
11373182|NCT01928394|OG024|Outcome|OC Arm N-I Dose Level 2c:|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W
11373183|NCT01928394|EG000|Reported Event|TNBC Arm N|Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
11373184|NCT01928394|EG001|Reported Event|TNBC Arm N-I Dose Level 1|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373185|NCT01928394|EG002|Reported Event|TNBC Arm N-I Dose Level 2|Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373186|NCT01928394|EG003|Reported Event|GC Arm N|Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
11373187|NCT01928394|EG004|Reported Event|GC Arm N-I Dose Level 1|Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373188|NCT01928394|EG005|Reported Event|GC Arm N-I Dose Level 2|Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
11373189|NCT01928394|EG006|Reported Event|GC Arm N-I Dose Level 2b|Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373190|NCT01928394|EG007|Reported Event|PC Arm N|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
11373191|NCT01928394|EG008|Reported Event|PC Arm N-I Dose Level 1|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373192|NCT01928394|EG009|Reported Event|PC Arm N-I Dose Level 2|Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373193|NCT01928394|EG010|Reported Event|PC Arm N-I Dose Level 2d|Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
11373194|NCT01928394|EG011|Reported Event|SCLC Arm N|Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W
11373195|NCT01928394|EG012|Reported Event|SCLC Arm N-I Dose Level 2|Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi
10850218|NCT00300495|EG001|Reported Event|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
10850219|NCT00300677|BG000|Baseline|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
11337332|NCT03582813|FG000|Participant Flow|Self-directed Care|"Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods..~Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system"
10962856|NCT00868751|EG000|Reported Event|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
10962857|NCT00868790|BG000|Baseline|All Randomized Participants|All randomized participants who took at least one dose of study treatment
11373196|NCT01928394|EG013|Reported Event|SCLC Arm N-I Dose Level 1|Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W
11373197|NCT01928394|EG014|Reported Event|SCLC Arm N-I Dose Level 2b|Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
11373198|NCT01928394|EG015|Reported Event|BC Arm N|Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W
11373199|NCT01928394|EG016|Reported Event|BC Arm N-I Dose Level 2|Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373200|NCT01928394|EG017|Reported Event|BC Arm N-I Dose Level 2b|Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
11373201|NCT01928394|EG018|Reported Event|OC Arm N-I Dose Level 2|"Ovarian cancer (OC) participants:~Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W"
11373202|NCT01928394|EG019|Reported Event|OC Arm N-I Dose Level 2b|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W
11373203|NCT01928394|EG020|Reported Event|OC Arm N-I Dose Level 2c|Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W
11373204|NCT01657500|BG000|Baseline|Life 4°C Media for Cornea Storage|"Donor cornea is stored in the Life 4°C media prior to implantation.~Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to implantation."
11373205|NCT01657500|BG001|Baseline|Optisol GS|"Donor cornea is stored in the Optisol GS media prior to implantation.~Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for implantation"
11373206|NCT01657500|BG002|Baseline|Total|Total of all reporting groups
11373207|NCT01657500|FG000|Participant Flow|Life 4°C Media for Cornea Storage|"Donor cornea is stored in the Life 4°C media prior to implantation.~Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to implantation."
11373208|NCT01657500|FG001|Participant Flow|Optisol GS|"Donor cornea is stored in the Optisol GS media prior to implantation.~Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for implantation"
11373209|NCT01657500|OG000|Outcome|Optisol GS|Time after keratoplasty Number of pairs Life 4°C (mean ± SD) Optisol GS (mean ± SD
11373210|NCT01657500|OG001|Outcome|Life 4C|
11373211|NCT01657500|EG000|Reported Event|Life 4°C Media for Cornea Storage|"Donor cornea is stored in the Life 4°C media prior to transplantation.~Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to transplantation.~Air was reinjected in 4 eyes to treat partial graft detachment. During the 6-month follow-up period, 1 graft experienced a graft rejection episode, which responded to increased topical corticosteroid therapy. 5 eyes had intraocular pressure (IOP) elevation requiring use of glaucoma medications or reduction of topicalcorticosteroid strength or dosing frequency. 2 eyes had laser capsulotomy to treat capsular haze. 1 eye had recurrent erosions because of peripheral bullae and was treated with lamellar keratectomy, and 1 eye was diagnosed with herpes simplex virus keratitis and was treated with antiviral medication. Altogether, 14 of 27 eyes (52%) in each corneal storage solution group had a postoperative intervention (P = 1.0)."
11373212|NCT01657500|EG001|Reported Event|Optisol GS|"Donor cornea is stored in the Optisol GS media prior to transplantation~Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for transplantation In the early postoperative period, 1 DSAEK graft in the Optisol GS group was repositioned because it fully detached. Air was reinjected in 2 eyes to treat partial graft detachment. During the 6-month follow-up period, 1 graft experienced a graft rejection episodes, which responded to increased topical corticosteroid therapy. 7 eyes had intraocular pressure (IOP) elevation requiring use of glaucoma medications or reduction of topical corticosteroid strength or dosing frequency. 2 eyes had laser capsulotomy to treat capsular haze. 1 eye had a vitreous strand associated with a capsular tear during cataract removal and was treated with laser vitreolysis.Altogether, 14 of 27 eyes (52%) in each corneal storage solution group had a postoperative intervention (P = 1.0)."
11376703|NCT02711137|FG008|Participant Flow|Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg|Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
11376704|NCT02711137|FG009|Participant Flow|Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376705|NCT02711137|FG010|Participant Flow|Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376706|NCT02711137|FG011|Participant Flow|Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
11373213|NCT04810221|BG000|Baseline|Experimental|Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
11373214|NCT04810221|FG000|Participant Flow|Experimental|Measure of peripheral oxygen saturation (SpO2) and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
11373215|NCT04810221|OG000|Outcome|Experimental|Controlled desaturation study: Measure of SpO2 and Heart Rate by BrOxy M device and a reference device in a controlled desaturation study, in paired observations.
11373216|NCT04810221|EG000|Reported Event|Experimental|Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
11373217|NCT04575038|BG000|Baseline|Standard of Care + Brequinar 100 mg|"Standard of Care + Brequinar oral capsules 100 mg x 5 days~Brequinar: Dihydroorotate dehydrogenase inhibitor (DHODHi)"
11373218|NCT04575038|BG001|Baseline|Standard of Care + Placebo|"Standard of Care + Placebo for Brequinar oral capsules x 5 days~Placebo: Placebo capsules"
11373219|NCT04575038|BG002|Baseline|Total|Total of all reporting groups
11373220|NCT04575038|FG000|Participant Flow|Standard of Care + Brequinar 100 mg|"Standard of Care + Brequinar oral capsules 100 mg x 5 days~Brequinar: Dihydroorotate dehydrogenase inhibitor (DHODHi)"
11373221|NCT04575038|FG001|Participant Flow|Standard of Care + Placebo|"Standard of Care + Placebo for Brequinar oral capsules x 5 days~Placebo: Placebo capsules"
11373222|NCT04575038|OG000|Outcome|Standard of Care + Brequinar 100 mg|"Standard of Care + Brequinar oral capsules 100 mg x 5 days~Brequinar: Dihydroorotate dehydrogenase inhibitor (DHODHi)"
11373223|NCT04575038|OG001|Outcome|Standard of Care + Placebo|"Standard of Care + Placebo for Brequinar oral capsules x 5 days~Placebo: Placebo capsules"
11373224|NCT04575038|EG000|Reported Event|Standard of Care + Brequinar 100 mg|"Standard of Care + Brequinar oral capsules 100 mg x 5 days~Brequinar: Dihydroorotate dehydrogenase inhibitor (DHODHi)"
11373225|NCT04575038|EG001|Reported Event|Standard of Care + Placebo|"Standard of Care + Placebo for Brequinar oral capsules x 5 days~Placebo: Placebo capsules"
11376707|NCT02711137|FG012|Participant Flow|Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
11376708|NCT02711137|FG013|Participant Flow|Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
11376709|NCT02711137|FG014|Participant Flow|Enrolled But Not Dosed|3 participants enrolled in the study and discontinued the study before study drug is administered
11376710|NCT02711137|OG000|Outcome|Part1/Treatment Group A : 8mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376711|NCT02711137|OG001|Outcome|Part1/Treatment Group A : 12mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376712|NCT02711137|OG002|Outcome|Part1/Treatment Group A : 16mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376713|NCT02711137|OG003|Outcome|Part1/Treatment Group B : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
11376714|NCT02711137|OG004|Outcome|Part1/Treatment Group B : 12mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
11376715|NCT02711137|OG005|Outcome|Part1/Treatment Group C : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
11376716|NCT02711137|OG006|Outcome|Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11376717|NCT02711137|OG007|Outcome|Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11376718|NCT02711137|OG008|Outcome|Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg|Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
11376719|NCT02711137|OG009|Outcome|Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376720|NCT02711137|OG010|Outcome|Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11373226|NCT04545567|BG000|Baseline|RocketAP First, Then USS Virginia|"Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Experimental-Control Arm underwent the Experimental Admission first, utilizing a meal-related fully automated artificial pancreas (AP) controller (RocketAP), followed by the Control Admission, which utilized a hybrid AP controller (USS-Virginia) with no washout period in between.~During the 96-hour admission, study participants started using RocketAP (48h) around midday on Day 1 and switched to USS Virginia (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4."
11373227|NCT04545567|BG001|Baseline|USS Virginia First, Then Rocket AP|"Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Control-Experimental Arm underwent the Control Admission first, utilizing a hybrid AP controller (USS-Virginia) first followed by a meal-related fully automated artificial pancreas (AP) controller (RocketAP) with no washout period in between.~During the 96-hour admission, study participants started with USS Virginia (48h) around midday on Day 1 and switched to RocketAP (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4."
11373228|NCT04545567|BG002|Baseline|Total|Total of all reporting groups
11373229|NCT04545567|FG000|Participant Flow|RocketAP First, Then USS Virginia|"Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Experimental-Control Arm underwent the Experimental Admission first, utilizing a meal-related fully automated artificial pancreas (AP) controller (RocketAP), followed by the Control Admission, which utilized a hybrid AP controller (USS-Virginia) with no washout period in between.~During the 96-hour admission, study participants started using RocketAP (48h) around midday on Day 1 and switched to USS Virginia (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4."
11373230|NCT04545567|FG001|Participant Flow|USS Virginia First, Then Rocket AP|"Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Control-Experimental Arm underwent the Control Admission first, utilizing a hybrid AP controller (USS-Virginia) first followed by a meal-related fully automated artificial pancreas (AP) controller (RocketAP) with no washout period in between.~During the 96-hour admission, study participants started with USS Virginia (48h) around midday on Day 1 and switched to RocketAP (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4."
11373231|NCT04545567|OG000|Outcome|RocketAP|Adolescents will be assessed for a 48-hour period on Rocket AP (Experimental condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement.
11373232|NCT04545567|OG001|Outcome|USS Virginia|Adolescents will be assessed for a 48-hour period on USS Virginia (Control condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement.
11373233|NCT04545567|EG000|Reported Event|RocketAP|Adolescents will be assessed for a 48-hour period on Rocket AP (Experimental condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement.
11373234|NCT04545567|EG001|Reported Event|USS Virginia|Adolescents will be assessed for a 48-hour period on USS Virginia (Control condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement.
11373235|NCT04425538|BG000|Baseline|Infliximab|"All patients enrolled into this trial will be assigned to the Infliximab arm. Patients will be treated with infliximab on Day 1, and may be re-treated per protocol and at the discretion of the investigator.~Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator"
11373236|NCT04425538|FG000|Participant Flow|Infliximab|"All patients enrolled into this trial will be assigned to the Infliximab arm. Patients will be treated with infliximab on Day 1, and may be re-treated per protocol and at the discretion of the investigator.~Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator"
11373237|NCT04425538|OG000|Outcome|Infliximab|"All patients enrolled into this trial will be assigned to the Infliximab arm. Patients will be treated with infliximab on Day 1, and may be re-treated per protocol and at the discretion of the investigator.~Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator"
11373238|NCT04425538|EG000|Reported Event|Infliximab|"All patients enrolled into this trial will be assigned to the Infliximab arm. Patients will be treated with infliximab on Day 1, and may be re-treated per protocol and at the discretion of the investigator.~Infliximab: Either infliximab or infliximab-abda will be used at the discretion of the investigator"
11373239|NCT04397757|BG000|Baseline|COVID-19 Convalescent Plasma|"COVID-19 Convalescent plasma on Study Day 1 in addition to standard care~COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type"
11373240|NCT04397757|BG001|Baseline|Standard of Care|Standard care alone
11373241|NCT04397757|BG002|Baseline|Total|Total of all reporting groups
11373242|NCT04397757|FG000|Participant Flow|COVID-19 Convalescent Plasma|On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
11373243|NCT04397757|FG001|Participant Flow|Standard of Care|Standard of care treatment administered only
11373244|NCT04397757|OG000|Outcome|COVID-19 Convalescent Plasma|"COVID-19 Convalescent plasma on Study Day 1 in addition to standard care~COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type"
11373245|NCT04397757|OG001|Outcome|Standard of Care|Standard care alone
10850220|NCT00300677|FG000|Participant Flow|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
10850221|NCT00300677|OG000|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
10850222|NCT00300677|EG000|Reported Event|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
10850223|NCT00300742|BG000|Baseline|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
11373246|NCT04397757|OG000|Outcome|Treatment|On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
11373247|NCT04397757|OG001|Outcome|Control|Standard of care treatment administered only
11373248|NCT04397757|OG001|Outcome|Standard Care|Standard care alone
11373249|NCT04397757|OG000|Outcome|COVID-19 Convalescent Plasma|On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
11373250|NCT04397757|OG001|Outcome|Standard of Care|Standard of care treatment administered only
11373251|NCT04397757|EG000|Reported Event|Treatment|On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
11373252|NCT04397757|EG001|Reported Event|Control|Standard of care treatment administered only
11373253|NCT04388683|BG000|Baseline|Intervention|"Will receive study drug treatment.~Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization (day 1), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM."
11373254|NCT04388683|BG001|Baseline|Control|Will receive standard of care.
11373255|NCT04388683|BG002|Baseline|Total|Total of all reporting groups
11373256|NCT04388683|FG000|Participant Flow|Inhaled Nitric Oxide|"Will receive study drug treatment.~Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization (day 1), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM."
11373257|NCT04388683|FG001|Participant Flow|Standard of Care|Will receive standard of care.
11373258|NCT04388683|OG000|Outcome|Intervention|"Will receive study drug treatment.~Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization (day 1), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM."
11373259|NCT04388683|OG001|Outcome|Control|Will receive standard of care.
10850224|NCT00300742|FG000|Participant Flow|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
10850225|NCT00300742|OG000|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
11373260|NCT04388683|EG000|Reported Event|Intervention|"Will receive study drug treatment.~Nitric Oxide: Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization (day 1), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM."
11373261|NCT04388683|EG001|Reported Event|Control|Will receive standard of care.
11373262|NCT04382651|BG000|Baseline|MAS825 + SoC|Single dose of MAS825 by intravenous infusion in addition to SoC
11373263|NCT04382651|BG001|Baseline|Placebo + SoC|Single dose of matching Placebo by intravenous infusion in addition to SoC
11373264|NCT04382651|BG002|Baseline|Total|Total of all reporting groups
11373265|NCT04382651|FG000|Participant Flow|MAS825 + SoC|Single dose of MAS825 by intravenous infusion in addition to SoC
11373266|NCT04382651|FG001|Participant Flow|Placebo + SoC|Single dose of matching Placebo by intravenous infusion in addition to SoC
11373267|NCT04382651|OG000|Outcome|MAS825 + SoC|Single dose of MAS825 by intravenous infusion in addition to SoC
11373268|NCT04382651|OG001|Outcome|Placebo + SoC|Single dose of matching Placebo by intravenous infusion in addition to SoC
11373269|NCT04382651|EG000|Reported Event|MAS825 + SoC|Single dose of MAS825 by intravenous infusion in addition to SoC
11373270|NCT04382651|EG001|Reported Event|Placebo + SoC|Single dose of matching Placebo by intravenous infusion in addition to SoC
11373271|NCT04382651|EG002|Reported Event|Total|Total
11373272|NCT04329832|BG000|Baseline|Hydroxychloroquine|Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
11373273|NCT04329832|BG001|Baseline|Azithromycin|Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
11373274|NCT04329832|BG002|Baseline|Total|Total of all reporting groups
11376721|NCT02711137|OG011|Outcome|Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
11373275|NCT04329832|FG000|Participant Flow|Hydroxychloroquine|Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
10850226|NCT00300742|OG000|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
10850227|NCT00300742|EG000|Reported Event|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
11373276|NCT04329832|FG001|Participant Flow|Azithromycin|Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
11337333|NCT03582813|FG001|Participant Flow|Services as Usual|"Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.~Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency"
11373277|NCT04329832|OG000|Outcome|Day 14 WHO COVID Score: Hydroxychloroquine|The median WHO COVID Score at Day 14 for patients in the hydroxychloroquine arm
11373278|NCT04329832|OG001|Outcome|Day 14 WHO COVID Score: Azithromycin|The median WHO COVID Score at Day 14 for patients in the azithromycin arm
10850228|NCT00300755|BG000|Baseline|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
11373279|NCT04329832|OG000|Outcome|Hydroxychloroquine|The median number of hospital-free days for hydroxychloroquine (Interquartile range)
11373280|NCT04329832|OG001|Outcome|Azithromycin|The median number of hospital-free days for azithromycin (Interquartile range)
10962858|NCT00868790|FG000|Participant Flow|PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
11190618|NCT02127372|OG000|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
11373281|NCT04329832|OG000|Outcome|Ventilator-Free Days at Day 28 for Hydroxychloroquine Arm|Number of days that the patient is not on a ventilator up to 28 days following admission for patients in the Hydroxychloroquine Arm
10962859|NCT00868790|FG001|Participant Flow|MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
11190619|NCT02127372|OG000|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
11190620|NCT02127372|OG001|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
11373282|NCT04329832|OG001|Outcome|Ventilator-Free Days at Day 28 for Azithromycin Arm|Number of days that the patient is not on a ventilator up to 28 days following admission for patients in the Azithromycin Arm
11373283|NCT04329832|OG000|Outcome|Hydroxychloroquine|The median ICU-free days for hydroxychloroquine (Interquartile Range)
11373284|NCT04329832|OG001|Outcome|Azithromycin|The median ICU-free days for azithromycin (Interquartile Range)
11190621|NCT02127372|EG000|Reported Event|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
11373285|NCT04329832|OG000|Outcome|Days to a 1-point Decrease in WHO COVID Scale in Hydroxychloroquine Arm|Time (in days) until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale for patients in the Hydroxychloroquine Arm.
11373286|NCT04329832|OG001|Outcome|Days to a 1-point Decrease in WHO COVID Scale in Azithromycin Arm|Time (in days) until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale for patients in the Azithromycin Arm.
11373287|NCT04329832|EG000|Reported Event|Hydroxychloroquine|Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
11373288|NCT04329832|EG001|Reported Event|Azithromycin|Azithromycin: Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
11376722|NCT02711137|OG012|Outcome|Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
11376723|NCT02711137|OG013|Outcome|Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
11376724|NCT02711137|OG000|Outcome|8mg QD INCB057643|cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC.
11376725|NCT02711137|OG001|Outcome|12mg QD INCB057643|12mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.
11376726|NCT02711137|OG002|Outcome|16mg QD INCB057643|Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
11190622|NCT02127372|EG001|Reported Event|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
11376727|NCT02711137|OG000|Outcome|8mg QD INCB057643|Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
11376728|NCT02711137|OG001|Outcome|12mg QD INCB057643|Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.
11376729|NCT02711137|OG001|Outcome|12mg QD INCB057643|Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA
11376730|NCT02711137|OG000|Outcome|12mg QD INCB057643|Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in Part 2 TGA and TGB
10850229|NCT00300755|BG001|Baseline|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
10850230|NCT00300755|BG002|Baseline|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
10850231|NCT00300755|BG003|Baseline|Total|Total of all reporting groups
11376731|NCT02711137|EG000|Reported Event|Part1/Treatment Group A : 8mg QD INCB057643|"Part1/Treatment Group A : 8mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376732|NCT02711137|EG001|Reported Event|Part1/Treatment Group A : 12mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376733|NCT02711137|EG002|Reported Event|Part1/Treatment Group A : 16mg QD INCB057643|"Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.~Treatment Group A included solid tumors and lymphoma"
11376734|NCT02711137|EG003|Reported Event|Part1/Treatment Group B : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
11376735|NCT02711137|EG004|Reported Event|Part1/Treatment Group B : 12mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
11376736|NCT02711137|EG005|Reported Event|Part1/Treatment Group C : 8mg QD INCB057643|Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
11373289|NCT04112303|BG000|Baseline|SOF/VEL|Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
11373290|NCT04112303|FG000|Participant Flow|SOF/VEL|Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
11373291|NCT04112303|OG000|Outcome|SOF/VEL|Participants received SOF/VEL FDC (400/100 mg) tablet orally once daily for up to 12 weeks.
11373292|NCT04112303|EG000|Reported Event|SOF/VEL|Participants received sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) (400/100 mg) tablet orally once daily for up to 12 weeks.
11373318|NCT03732534|BG000|Baseline|Valbenazine|Participants received valbenazine once daily for up to 96 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11373319|NCT03732534|FG000|Participant Flow|Valbenazine|Participants received valbenazine once daily for up to 96 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11373320|NCT03732534|OG000|Outcome|Valbenazine|Participants received valbenazine once daily for up to 96 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11373321|NCT03732534|EG000|Reported Event|Valbenazine|Participants received valbenazine once daily for up to 96 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11373322|NCT03692910|BG000|Baseline|Part A (Open-label): SAGE-217|Participants self-administered SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14.
11373323|NCT03692910|FG000|Participant Flow|Part A (Open-label): SAGE-217|Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD), in the evening, from Day 1 to Day 14.
11373324|NCT03692910|FG001|Participant Flow|Part B (Double-blind): SAGE-217|Participants were to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.
11373325|NCT03692910|FG002|Participant Flow|Part B (Double-blind): Placebo|Participants were to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.
11373326|NCT03692910|OG000|Outcome|Part A (Open-label): SAGE-217|Participants self-administered SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14.
11373327|NCT03692910|OG000|Outcome|Part B (Double-blind): SAGE-217|Participants were to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.
11373328|NCT03692910|OG001|Outcome|Part B (Double-blind): Placebo|Participants were to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.
11373329|NCT03692910|EG000|Reported Event|Part A (Open-label): SAGE-217|Participants self-administered SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14.
11373330|NCT03673956|BG000|Baseline|Mupirocin Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373331|NCT03673956|BG001|Baseline|Tobramycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373332|NCT03673956|BG002|Baseline|Levofloxacin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373333|NCT03673956|BG003|Baseline|Vancomycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373334|NCT03673956|BG004|Baseline|Total|Total of all reporting groups
11190623|NCT02127567|BG000|Baseline|All Participants|
11373293|NCT03896477|BG000|Baseline|Pneumosil|Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373294|NCT03896477|BG001|Baseline|Synflorix|Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373295|NCT03896477|BG002|Baseline|Prevenar 13|Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373296|NCT03896477|BG003|Baseline|Total|Total of all reporting groups
11373297|NCT03896477|FG000|Participant Flow|Pneumosil|Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373298|NCT03896477|FG001|Participant Flow|Synflorix|Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373299|NCT03896477|FG002|Participant Flow|Prevenar 13|Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373300|NCT03896477|OG000|Outcome|Pneumosil|Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373301|NCT03896477|OG001|Outcome|Synflorix|Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373302|NCT03896477|OG002|Outcome|Prevenar 13|Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373303|NCT03896477|OG000|Outcome|Pneumosil|Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks.
11373304|NCT03896477|OG001|Outcome|Synflorix|Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks.
11373305|NCT03896477|OG002|Outcome|Prevenar 13|Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks.
11373306|NCT03896477|EG000|Reported Event|Pneumosil|Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373307|NCT03896477|EG001|Reported Event|Synflorix|Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373308|NCT03896477|EG002|Reported Event|Prevenar 13|Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
11373309|NCT03760185|BG000|Baseline|All Patients|"All patients in this arm will receive eye drops to be applied to one eye only. The alternative eye will not receive any eye drops and as such will serve as the control.~Brimonidine Tartrate: All subjects will apply brimonidine tartrate to one eye only for the duration of study participation."
11373310|NCT03760185|FG000|Participant Flow|Brimonidine Tartrate 0.2%|All enrolled subjects will receive the interventional drug, Brimonidine tartrate 0.2%, to be applied to ONE eye only.
10850232|NCT00300755|FG000|Participant Flow|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
11373311|NCT03760185|FG001|Participant Flow|Control- Untreated|All subjects enrolled will have one eye serve as a control and will not receive the Brimonidine Tartrate 0.2% treatment
11373312|NCT03760185|OG000|Outcome|Brimonidine Tartrate 0.2%|The eye that was treated with Brimonidine Tartrate 0.2%.
11373313|NCT03760185|OG001|Outcome|Control - Untreated|Eye of participant that was not treated with Brimonidine Tartrate 0.2%
11373314|NCT03760185|OG000|Outcome|Brimonidine Tartrate 0.2%|Eye that was treated with Brimonidine Tartrate 0.2%
11373315|NCT03760185|OG001|Outcome|Control - Untreated|Eye that was not treated with Brimonidine Tartrate 0.2%
11373316|NCT03760185|EG000|Reported Event|Brimonidine Tartrate 0.2%|The eye that was treated with Brimonidine Tartrate 0.2%.
11373317|NCT03760185|EG001|Reported Event|Control- Untreated|The eye that was not treated with Brimonidine Tartrate 0.2%.
11373335|NCT03673956|FG000|Participant Flow|Mupirocin Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373336|NCT03673956|FG001|Participant Flow|Tobramycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373337|NCT03673956|FG002|Participant Flow|Levofloxacin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
10850233|NCT00300755|FG001|Participant Flow|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
11373338|NCT03673956|FG003|Participant Flow|Vancomycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373339|NCT03673956|OG000|Outcome|Mupirocin Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373340|NCT03673956|OG001|Outcome|Tobramycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373341|NCT03673956|OG002|Outcome|Levofloxacin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373342|NCT03673956|OG003|Outcome|Vancomycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373343|NCT03673956|EG000|Reported Event|Mupirocin Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373344|NCT03673956|EG001|Reported Event|Tobramycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373345|NCT03673956|EG002|Reported Event|Levofloxacin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373346|NCT03673956|EG003|Reported Event|Vancomycin Topical Antibiotic Nasal Saline Rinse|"Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.~Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days."
11373347|NCT03649347|BG000|Baseline|AR Therapy Intervention for Spider Phobia|Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.
10850234|NCT00300755|FG002|Participant Flow|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
11373348|NCT03649347|BG001|Baseline|No Treatment Control Group for Spider Phobia|This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
11373349|NCT03649347|BG002|Baseline|AR Therapy Intervention for Fear of Snakes|Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.
11373350|NCT03649347|BG003|Baseline|No Treatment Control Group for Fear of Snakes|This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
11373351|NCT03649347|BG004|Baseline|Total|Total of all reporting groups
11373352|NCT03649347|FG000|Participant Flow|AR Therapy Intervention for Spider Phobia|AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.
11373353|NCT03649347|FG001|Participant Flow|No Treatment Control Group for Spider Phobia|The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.
11373354|NCT03649347|FG002|Participant Flow|AR Therapy Intervention for Snake Phobia|Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.
11373355|NCT03649347|FG003|Participant Flow|No Treatment Control Group for Snake Phobia|This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
11373356|NCT03649347|OG000|Outcome|AR Therapy Intervention for Spider Phobia|AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.
11373357|NCT03649347|OG001|Outcome|No Treatment Control Group for Spider Phobia|The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.
11373358|NCT03649347|OG002|Outcome|AR Therapy Intervention for Snake Phobia|Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.
11373359|NCT03649347|OG003|Outcome|No Treatment Control Group for Snake Phobia|This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
11190624|NCT02127567|FG000|Participant Flow|All Participants|"All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
11190625|NCT02127567|OG000|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
11190626|NCT02127567|OG001|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
11190627|NCT02127567|OG000|Outcome|Online Writing Tool|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
11190628|NCT02127567|OG001|Outcome|Writing With no Specific Support.|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
11190629|NCT02127567|EG000|Reported Event|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
11190630|NCT02127567|EG001|Reported Event|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
11190631|NCT02127632|BG000|Baseline|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
11190632|NCT02127632|BG001|Baseline|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
11190633|NCT02127632|BG002|Baseline|Total|Total of all reporting groups
10850235|NCT00300755|OG000|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
10850236|NCT00300755|OG001|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
11190634|NCT02127632|FG000|Participant Flow|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
11373360|NCT03649347|EG000|Reported Event|AR Therapy Intervention for Spider Phobia|AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.
11373361|NCT03649347|EG001|Reported Event|No Treatment Control Group for Spider Phobia|The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.
11373362|NCT03641326|BG000|Baseline|Participants With Primary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373363|NCT03641326|BG001|Baseline|Participants With Secondary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373364|NCT03641326|BG002|Baseline|Total|Total of all reporting groups
11373365|NCT03641326|FG000|Participant Flow|Participants With Primary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373366|NCT03641326|FG001|Participant Flow|Participants With Secondary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373367|NCT03641326|OG000|Outcome|Participants With Primary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373368|NCT03641326|OG001|Outcome|Participants With Secondary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373369|NCT03641326|OG000|Outcome|Responders With Primary Gliosarcoma|A responder is a participant with a Complete Response (CR) or Partial Response (PR).
11373370|NCT03641326|OG001|Outcome|Non-Responders With Primary Gliosarcoma|A non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD).
11373371|NCT03641326|OG002|Outcome|Responders With Secondary Gliosarcoma|A responder is a participant with a Complete Response (CR) or Partial Response (PR).
11373372|NCT03641326|OG003|Outcome|Non-Responders With Secondary Gliosarcoma|A non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD).
11373373|NCT03641326|OG000|Outcome|Participants With Primary Gliosarcoma and Secondary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373374|NCT03641326|EG000|Reported Event|Participants With Primary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373375|NCT03641326|EG001|Reported Event|Participants With Secondary Gliosarcoma|Sunitinib administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
11373376|NCT03618420|BG000|Baseline|Clinical Investigation|"All participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes Dual X-Ray Absorptiometry (DXA), renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.~Aminohippurate Sodium Inj 20%: Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)~Iohexol Inj 300 mg/mL: Diagnostic aid/agent used to measure glomerular filtration rate (GFR)"
11376737|NCT02711137|EG006|Reported Event|Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11373377|NCT03618420|FG000|Participant Flow|Clinical Investigation|"All participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes Dual X-Ray Absorptiometry (DXA), renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.~Aminohippurate Sodium Inj 20%: Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)~Iohexol Inj 300 mg/mL: Diagnostic aid/agent used to measure glomerular filtration rate (GFR)"
11373378|NCT03618420|OG000|Outcome|Clinical Investigation|"All participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes Dual X-Ray Absorptiometry (DXA), renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.~Aminohippurate Sodium Inj 20%: Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)~Iohexol Inj 300 mg/mL: Diagnostic aid/agent used to measure glomerular filtration rate (GFR)"
11373379|NCT03618420|EG000|Reported Event|Clinical Investigation|"All participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes Dual X-Ray Absorptiometry (DXA), renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.~Aminohippurate Sodium Inj 20%: Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)~Iohexol Inj 300 mg/mL: Diagnostic aid/agent used to measure glomerular filtration rate (GFR)"
11373380|NCT03411031|BG000|Baseline|A: Elotuzumab + Lenalidomide at 25 mg|"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373381|NCT03411031|BG001|Baseline|B: Elotuzumab + Lenalidomide at 10 mg|"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373382|NCT03411031|BG002|Baseline|Total|Total of all reporting groups
11373383|NCT03411031|FG000|Participant Flow|A: Elotuzumab + Lenalidomide at 25 mg|"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373384|NCT03411031|FG001|Participant Flow|B: Elotuzumab + Lenalidomide at 10 mg|"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373385|NCT03411031|OG000|Outcome|A: Elotuzumab + Lenalidomide at 25 mg|"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373386|NCT03411031|OG001|Outcome|B: Elotuzumab + Lenalidomide at 10 mg|"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373387|NCT03411031|EG000|Reported Event|A: Elotuzumab + Lenalidomide at 25 mg|"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373388|NCT03411031|EG001|Reported Event|B: Elotuzumab + Lenalidomide at 10 mg|"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.~Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.~Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.~Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.~Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
11373389|NCT03365752|BG000|Baseline|Chloroprocaine|Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
11373390|NCT03365752|BG001|Baseline|Mepivacaine|Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
11373391|NCT03365752|BG002|Baseline|General Anesthesia|General Anesthetics: General anesthetics will be administered intravenously
11373392|NCT03365752|BG003|Baseline|Total|Total of all reporting groups
11373393|NCT03365752|FG000|Participant Flow|Chloroprocaine|Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
11373394|NCT03365752|FG001|Participant Flow|Mepivacaine|Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
11373395|NCT03365752|FG002|Participant Flow|General Anesthesia|General Anesthetics: General anesthetics will be administered intravenously
11373396|NCT03365752|OG000|Outcome|Chloroprocaine|Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
11373397|NCT03365752|OG001|Outcome|Mepivacaine|Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
11373398|NCT03365752|OG002|Outcome|General Anesthesia|General Anesthetics: General anesthetics will be administered intravenously
11373399|NCT03365752|EG000|Reported Event|Chloroprocaine|Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
11373400|NCT03365752|EG001|Reported Event|Mepivacaine|Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
11373401|NCT03365752|EG002|Reported Event|General Anesthesia|General Anesthetics: General anesthetics will be administered intravenously
11373402|NCT03364036|BG000|Baseline|Experimental: Mavenclad®|Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
11373403|NCT03364036|FG000|Participant Flow|Experimental: Mavenclad®|Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
11373404|NCT03364036|OG000|Outcome|Experimental: Mavenclad®|Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
11373405|NCT03364036|EG000|Reported Event|Experimental: Mavenclad®|Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
11376738|NCT02711137|EG007|Reported Event|Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort|Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
11190635|NCT02127632|FG001|Participant Flow|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
11376739|NCT02711137|EG008|Reported Event|Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg|Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
11376740|NCT02711137|EG009|Reported Event|Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376741|NCT02711137|EG010|Reported Event|Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
11376742|NCT02711137|EG011|Reported Event|Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
11376743|NCT02711137|EG012|Reported Event|Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
11376744|NCT02711137|EG013|Reported Event|Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg|Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
11373406|NCT03205163|BG000|Baseline|LDC: Advate 25 IU/kg Then BIVV001 25 IU/kg|Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BTP (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
11373407|NCT03205163|BG001|Baseline|HDC: Advate 65 IU/kg Then BIVV001 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
11373408|NCT03205163|BG002|Baseline|Total|Total of all reporting groups
11373409|NCT03205163|FG000|Participant Flow|Low Dose Cohort (LDC): Advate 25 IU/kg Then BIVV001 25 IU/kg|Participants received a single intravenous (IV) dose of Advate 25 International Units per kilogram (IU/kg) on Day 1 of Advate treatment period (ATP) (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BIVV001 treatment period (BTP) (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
11373410|NCT03205163|FG001|Participant Flow|High Dose Cohort (HDC): Advate 65 IU/kg Then BIVV001 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
11373411|NCT03205163|OG000|Outcome|Advate 25 IU/kg|Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
11373412|NCT03205163|OG001|Outcome|Advate 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
11373413|NCT03205163|OG000|Outcome|BIVV001 25 IU/kg|Participants received a single IV dose of BIVV001 25 IU/kg on Day 1 in BTP (28 days).
11373414|NCT03205163|OG001|Outcome|BIVV001 65 IU/kg|Participants received a single IV dose of BIVV001 65 IU/kg on Day 1 in BTP (28 days).
11373415|NCT03205163|OG000|Outcome|Low Dose Cohort (LDC): Advate 25 IU/kg Then BIVV001 25 IU/kg|Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BTP (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
11373416|NCT03205163|OG001|Outcome|High Dose Cohort (HDC): Advate 65 IU/kg Then BIVV001 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). Advate treatment period consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
11373417|NCT03205163|OG000|Outcome|Advate 25 IU/kg|Participants received a single IV dose of Advate 25 IU/kg on Day 1 in ATP (3 days).
11373418|NCT03205163|OG001|Outcome|BIVV001 25 IU/kg|Participants received a single IV dose of BIVV001 25 IU/kg on Day 1 in BTP (28 days).
11373419|NCT03205163|OG000|Outcome|Advate 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 in ATP (4 days).
11373420|NCT03205163|EG000|Reported Event|Advate Dose Level: 25 IU/kg|Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
11373421|NCT03205163|EG001|Reported Event|Advate Dose Level: 65 IU/kg|Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
11373422|NCT03205163|EG002|Reported Event|BIVV001 Dose Level: 25 IU/kg|Participants received a single IV dose of BIVV001 25 IU/kg on Day 1 in BTP (28 days).
11373423|NCT03205163|EG003|Reported Event|BIVV001 Dose Level: 65 IU/kg|Participants received a single IV dose of BIVV001 65 IU/kg on Day 1 in BTP (28 days).
11373424|NCT03178045|BG000|Baseline|Team Monitoring|Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
11373425|NCT03178045|BG001|Baseline|Enhanced Feedback|In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
11373426|NCT03178045|BG002|Baseline|Total|Total of all reporting groups
11373427|NCT03178045|FG000|Participant Flow|Team Monitoring|Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
11376745|NCT02630459|BG000|Baseline|DBTP: Placebo|Placebo SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376746|NCT02630459|BG001|Baseline|DBTP: Erenumab 28 mg QM|Erenumab 28 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376747|NCT02630459|BG002|Baseline|DPTP: Erenumab 70 mg QM|Erenumab 70 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376748|NCT02630459|BG003|Baseline|DBTP: Erenumab 140 mg QM|Erenumab 140 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376749|NCT02630459|BG004|Baseline|Total|Total of all reporting groups
11376750|NCT02630459|FG000|Participant Flow|DBTP: Placebo|Placebo SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11373428|NCT03178045|FG001|Participant Flow|Enhanced Feedback|In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
11373429|NCT03178045|OG000|Outcome|Team Monitoring|Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
11373430|NCT03178045|OG001|Outcome|Enhanced Feedback|In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
11373431|NCT03178045|OG002|Outcome|Difference in Participants Anxiety|Difference in Participants Anxiety Measured by PROCTCAE Survey
11373432|NCT03178045|EG000|Reported Event|Team Monitoring|Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
11373433|NCT03178045|EG001|Reported Event|Enhanced Feedback|In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
11373434|NCT03145766|BG000|Baseline|Group 1: VRVg-2 Formulation 1|VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373435|NCT03145766|BG001|Baseline|Group 2:VRVg-2 Formulation 2|VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373436|NCT03145766|BG002|Baseline|Group 3: VRVg-2 Formulation 3|VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373437|NCT03145766|BG003|Baseline|Group 4: VRVg-1|VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373438|NCT03145766|BG004|Baseline|Group 5: Imovax Rabies|Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373439|NCT03145766|BG005|Baseline|Total|Total of all reporting groups
11373440|NCT03145766|FG000|Participant Flow|Group 1: VRVg-2 Formulation 1|VRVg-2 formulation 1 (Low), intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.
11373441|NCT03145766|FG001|Participant Flow|Group 2:VRVg-2 Formulation 2|VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373442|NCT03145766|FG002|Participant Flow|Group 3: VRVg-2 Formulation 3|VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373443|NCT03145766|FG003|Participant Flow|Group 4: VRVg-1|VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373444|NCT03145766|FG004|Participant Flow|Group 5: Imovax Rabies|Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373445|NCT03145766|OG000|Outcome|Group 1: VRVg-2 Formulation 1|VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373446|NCT03145766|OG001|Outcome|Group 2:VRVg-2 Formulation 2|VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373447|NCT03145766|OG002|Outcome|Group 3: VRVg-2 Formulation 3|VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373448|NCT03145766|OG003|Outcome|Group 4: VRVg-1|VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373449|NCT03145766|OG004|Outcome|Group 5: Imovax Rabies|Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11190636|NCT02127632|OG000|Outcome|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
11373450|NCT03145766|OG002|Outcome|Group 3: VRVg-2 Formulation 3|VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0
11373451|NCT03145766|EG000|Reported Event|Group 1: VRVg-2 Formulation 1|VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373452|NCT03145766|EG001|Reported Event|Group 2: VRVg-2 Formulation 2|VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373453|NCT03145766|EG002|Reported Event|Group 3: VRVg-2 Formulation 3|VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373454|NCT03145766|EG003|Reported Event|Group 4: VRVg-1|VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373455|NCT03145766|EG004|Reported Event|Group 5: Imovax Rabies|Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.
11373456|NCT03106987|BG000|Baseline|Olaparib (BRCA1/2 +ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373457|NCT03106987|BG001|Baseline|Placebo (BRCA +ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373458|NCT03106987|BG002|Baseline|Olaparib (BRCA1/2 -ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373459|NCT03106987|BG003|Baseline|Placebo (BRCA 1/2 -ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373460|NCT03106987|BG004|Baseline|Total|Total of all reporting groups
11373461|NCT03106987|FG000|Participant Flow|Olaparib (BRCA1/2 +ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373462|NCT03106987|FG001|Participant Flow|Placebo (BRCA1/2 +ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373463|NCT03106987|FG002|Participant Flow|Olaparib (BRCA1/2 -ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373464|NCT03106987|FG003|Participant Flow|Placebo (BRCA1/2 -ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11190637|NCT02127632|OG001|Outcome|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
11373465|NCT03106987|OG000|Outcome|Olaparib (BRCA1/2 +ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373466|NCT03106987|OG001|Outcome|Placebo (BRCA1/2 +ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373467|NCT03106987|OG002|Outcome|Olaparib (BRCA1/2 -ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373468|NCT03106987|OG003|Outcome|Placebo (BRCA1/2 -ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373469|NCT03106987|EG000|Reported Event|Olaparib (BRCA1/2 +ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373470|NCT03106987|EG001|Reported Event|Placebo (BRCA1/2 +ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373471|NCT03106987|EG002|Reported Event|Olaparib (BRCA1/2 -ve)|Patients received olaparib 300mg tablets orally twice daily (bd) continuously
11373472|NCT03106987|EG003|Reported Event|Placebo (BRCA1/2 -ve)|Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
11373473|NCT03103087|BG000|Baseline|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373474|NCT03103087|BG001|Baseline|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373475|NCT03103087|BG002|Baseline|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks
11373476|NCT03103087|BG003|Baseline|Total|Total of all reporting groups
11373477|NCT03103087|FG000|Participant Flow|Relugolix Plus Estradiol (E2])/Norethindrone Acetate (NETA) (Group A)|Relugolix 40 milligrams (mg) co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373478|NCT03103087|FG001|Participant Flow|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373479|NCT03103087|FG002|Participant Flow|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373480|NCT03103087|OG000|Outcome|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373481|NCT03103087|OG001|Outcome|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373482|NCT03103087|OG001|Outcome|Placebo (Group C)|Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
11373483|NCT03103087|OG001|Outcome|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373484|NCT03103087|OG001|Outcome|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks
11373485|NCT03103087|EG000|Reported Event|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373486|NCT03103087|EG001|Reported Event|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373487|NCT03103087|EG002|Reported Event|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks
11373488|NCT03049735|BG000|Baseline|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373489|NCT03049735|BG001|Baseline|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373490|NCT03049735|BG002|Baseline|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373491|NCT03049735|BG003|Baseline|Total|Total of all reporting groups
11373492|NCT03049735|FG000|Participant Flow|Relugolix Plus Estradiol (E2)/ Norethindrone Acetate (NETA) (Group A)|Relugolix 40 milligrams (mg) co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373493|NCT03049735|FG001|Participant Flow|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.
11373494|NCT03049735|FG002|Participant Flow|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373495|NCT03049735|OG000|Outcome|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.
11373496|NCT03049735|OG001|Outcome|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373497|NCT03049735|OG001|Outcome|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with estradiol/norethindrone acetate (1.0/0.5 mg) for 12 weeks.
11373498|NCT03049735|EG000|Reported Event|Relugolix Plus E2/NETA (Group A)|Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for 24 weeks.
11373499|NCT03049735|EG001|Reported Event|Relugolix Plus Delayed E2/NETA (Group B)|Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with estradiol/norethindrone acetate (1.0/0.5 mg) for 12 weeks.
11373500|NCT03049735|EG002|Reported Event|Placebo (Group C)|Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.
11373501|NCT03021551|BG000|Baseline|Rainbow Sensor|Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
11373502|NCT03021551|FG000|Participant Flow|Rainbow Sensor|Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
11373503|NCT03021551|OG000|Outcome|Rainbow Sensor|Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
11373504|NCT03021551|EG000|Reported Event|Rainbow Sensor|Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
11373505|NCT02990338|BG000|Baseline|Pd (Pomalidomide + Dexamethasone)|Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
11373506|NCT02990338|BG001|Baseline|IPd (Isatuximab + Pomalidomide + Dexamethasone)|Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
11373507|NCT02990338|BG002|Baseline|Total|Total of all reporting groups
11373508|NCT02990338|FG000|Participant Flow|Pd (Pomalidomide + Dexamethasone)|Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
11373509|NCT02990338|FG001|Participant Flow|IPd (Isatuximab + Pomalidomide + Dexamethasone)|Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
11373510|NCT02990338|OG000|Outcome|Pd (Pomalidomide + Dexamethasone)|Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
11376751|NCT02630459|FG001|Participant Flow|DBTP: Erenumab 28 mg QM|Erenumab 28 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376752|NCT02630459|FG002|Participant Flow|DPTP: Erenumab 70 mg QM|Erenumab 70 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376753|NCT02630459|FG003|Participant Flow|DBTP: Erenumab 140 mg QM|Erenumab 140 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11373511|NCT02990338|OG001|Outcome|IPd (Isatuximab + Pomalidomide + Dexamethasone)|Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
11373512|NCT02990338|OG000|Outcome|IPd (Isatuximab + Pomalidomide + Dexamethasone)|Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
11373513|NCT02990338|EG000|Reported Event|Pd (Pomalidomide + Dexamethasone)|Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
11373514|NCT02990338|EG001|Reported Event|IPd (Isatuximab + Pomalidomide + Dexamethasone)|Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
11373515|NCT02972996|BG000|Baseline|Blueberry|Blueberry: 22 g freeze-dried whole blueberry powder
11373516|NCT02972996|BG001|Baseline|Placebo|Placebo: 22 g placebo blueberry powder
11373517|NCT02972996|BG002|Baseline|Total|Total of all reporting groups
11373518|NCT02972996|FG000|Participant Flow|Blueberry|Blueberry: 22 g freeze-dried whole blueberry powder
11373519|NCT02972996|FG001|Participant Flow|Placebo|Placebo: 22 g placebo blueberry powder
11373520|NCT02972996|OG000|Outcome|Blueberry|Blueberry: 22 g freeze-dried whole blueberry powder
11373521|NCT02972996|OG001|Outcome|Placebo|Placebo: 22 g placebo blueberry powder
11373522|NCT02972996|EG000|Reported Event|Blueberry|"22 g freeze-dried blueberries~Blueberry: 22 g freeze-dried whole blueberry powder"
11373523|NCT02972996|EG001|Reported Event|Placebo|"22 g placebo~Placebo: 22 g placebo blueberry powder"
11373524|NCT02932332|BG000|Baseline|Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373525|NCT02932332|BG001|Baseline|Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373526|NCT02932332|BG002|Baseline|Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373527|NCT02932332|BG003|Baseline|Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373528|NCT02932332|BG004|Baseline|Total|Total of all reporting groups
11373529|NCT02932332|FG000|Participant Flow|Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373530|NCT02932332|FG001|Participant Flow|Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373531|NCT02932332|FG002|Participant Flow|Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373532|NCT02932332|FG003|Participant Flow|Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min
11373533|NCT02932332|OG000|Outcome|Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min.
11373534|NCT02932332|OG001|Outcome|Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min.
11373535|NCT02932332|OG002|Outcome|Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min.
11373536|NCT02932332|OG003|Outcome|Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)|High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min.
11373537|NCT02932332|EG000|Reported Event|High Flow Air|High Flow Air was delivered between 20 and 60 L/min.
11373538|NCT02932332|EG001|Reported Event|High Flow Oxygen|High Flow Oxygen was delivered between 20 and 60 L/min.
11373539|NCT02932332|EG002|Reported Event|Low Flow Air|Low Flow Air was delivered at 2L/min.
11373540|NCT02932332|EG003|Reported Event|Low Flow Oxygen|Low Flow Oxygen was delivered at 2L/min.
11373541|NCT02845440|BG000|Baseline|Treatment as Usual (TAU) Cohort 1|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants
11373542|NCT02845440|BG001|Baseline|AD + CHW - Cohort 1|"Academic Detailing: (AD) is a targeted continuing medical education strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices.~Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training."
11373543|NCT02845440|BG002|Baseline|AD - Cohort 1|Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing Academic Detailing: Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.
11373544|NCT02845440|BG003|Baseline|CHW - Cohort 2|Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments that may be requested by patients and/or recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
11373545|NCT02845440|BG004|Baseline|Treatment as Usual (TAU) Cohort 2|Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.
11373546|NCT02845440|BG005|Baseline|Total|Total of all reporting groups
11373547|NCT02845440|FG000|Participant Flow|Treatment as Usual (TAU) Cohort 1|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants
11373548|NCT02845440|FG001|Participant Flow|AD + CHW - Cohort 1|"Academic Detailing: (AD) is a targeted continuing medical education strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices.~Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training."
11373549|NCT02845440|FG002|Participant Flow|AD - Cohort 1|"Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing~Academic Detailing: Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice."
11373550|NCT02845440|FG003|Participant Flow|CHW - Cohort 2|Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments that may be requested by patients and/or recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
11373551|NCT02845440|FG004|Participant Flow|Treatment as Usual (TAU) Cohort 2|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants.
11373552|NCT02845440|OG000|Outcome|Treatment as Usual (TAU) Cohort 1|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants
11373553|NCT02845440|OG001|Outcome|AD + CHW - Cohort 1|"Academic Detailing: (AD) is a targeted continuing medical education strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices.~Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training."
11373554|NCT02845440|OG002|Outcome|AD - Cohort 1|"Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing~Academic Detailing: Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice."
11373555|NCT02845440|OG000|Outcome|Treatment as Usual (TAU) - Cohort 1|"Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants.~Treatment as Usual (TAU): Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services."
11373556|NCT02845440|OG002|Outcome|AD - Cohort 1|"Participants who are randomized to this condition will only not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing as described above.~Academic Detailing: Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice."
11373557|NCT02845440|OG003|Outcome|CHW - Cohort 2|Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments that may be requested by patients and/or recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
11373558|NCT02845440|OG004|Outcome|Treatment as Usual (TAU) Cohort 2|Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.
11373559|NCT02845440|OG004|Outcome|Treatment as Usual (TAU) Cohort 2|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants. Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants
11373560|NCT02845440|OG003|Outcome|CHW - Cohort 2|"Community Health Worker (CHW) will offer to support patients and prescribers to implement smoking cessation treatments that may be requested by patients and/or recommended by prescribers.~Community Health Worker: Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training."
11373561|NCT02845440|OG004|Outcome|Treatment as Usual (TAU) - Cohort 2|"Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention. Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants~Treatment as Usual (TAU): Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services."
11373562|NCT02845440|EG000|Reported Event|Treatment as Usual (TAU) - Cohort 1|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants
11373563|NCT02845440|EG001|Reported Event|AD + CHW - Cohort 1|"Academic Detailing: (AD) is a targeted continuing medical education strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices.~Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training."
11373564|NCT02845440|EG002|Reported Event|AD - Cohort 1|"Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing~Academic Detailing: Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice."
11373565|NCT02845440|EG003|Reported Event|CHW - Cohort 2|Community Health Worker: (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments that may be requested by patients and/or recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
11373566|NCT02845440|EG004|Reported Event|Treatment as Usual (TAU) - Cohort 2|Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.
11376754|NCT02630459|FG004|Participant Flow|OLTP: Erenumab 70 mg QM (Initial OL Dose)|"Participants assigned to an initial erenumab dose of 70 mg QM SC in the OLTP.~After a protocol amendment, participants who had already completed the week 48 OLTP visit continued to receive OL erenumab 70 mg QM SC for a total of 76 weeks. Participants who had not yet completed the OLTP week 48 visit and were already receiving OL erenumab 70 mg QM SC increased their dose to erenumab 140 mg QM SC, continued until the week 100 visit for a total OLTP duration of 76 weeks."
11376755|NCT02630459|FG005|Participant Flow|OLTP: Erenumab 140 mg QM (Initial OL Dose)|"Participants assigned to an initial erenumab dose of 140 mg QM SC in the OLTP.~After a protocol amendment, participants who had not yet completed the DBTP and were not yet in the OLTP received an initial dose of erenumab 140 mg QM SC upon entering the OLTP, and continued receiving OL erenumab 140 mg QM SC for 76 weeks."
11376756|NCT02630459|FG006|Participant Flow|CHU Sub-Study: Two 70 mg/mL AI/Pens|A subset of participants in the OLTP randomized to self-administer erenumab via two 70 mg/mL AI/pens on CHU sub-study day 1, day 29 and day 57.
11376757|NCT02630459|FG007|Participant Flow|CHU Sub-Study: One 140 mg/mL AI/Pen|A subset of participants in the OLTP randomized to self-administer erenumab via one 140 mg/mL AI/pen on CHU sub-study day 1, day 29 and day 57.
11376758|NCT02630459|OG000|Outcome|DBTP: Placebo|Placebo SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376759|NCT02630459|OG001|Outcome|DBTP: Erenumab 28 mg QM|Erenumab 28 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376760|NCT02630459|OG002|Outcome|DPTP: Erenumab 70 mg QM|Erenumab 70 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376761|NCT02630459|OG003|Outcome|DBTP: Erenumab 140 mg QM|Erenumab 140 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376762|NCT02630459|OG000|Outcome|CHU Sub-Study: Two 70 mg/mL AI/Pens|A subset of participants in the OLTP randomized to self-administer erenumab via two 70 mg/mL AI/pens on CHU sub-study day 1, day 29 and day 57.
11190638|NCT02127632|EG000|Reported Event|Group ETT (Endo Tracheal Tube)|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.~Other Names:~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
11190639|NCT02127632|EG001|Reported Event|Group LM-S(Laryngeal Mask Supreme Group)|"Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482"
11190640|NCT02127710|BG000|Baseline|c-MET Positive [600mg AZD6094 po]|All participants tested for the presence of c-MET mutations
11190641|NCT02127710|BG001|Baseline|c-MET Negative [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11190642|NCT02127710|BG002|Baseline|c-MET Status Unknown [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11190643|NCT02127710|BG003|Baseline|Total|Total of all reporting groups
11190644|NCT02127710|FG000|Participant Flow|c-MET Positive [600mg AZD6094 po]|All participants tested for the presence of c-MET mutations
11190645|NCT02127710|FG001|Participant Flow|c-MET Negative [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11190646|NCT02127710|FG002|Participant Flow|c-MET Status Unknown [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11190647|NCT02127710|OG000|Outcome|Efficacy Analysis Set|All patients with measurable disease, PRCC confirmed by central laboratory and received at least 1 dose of study medication
11190648|NCT02127710|OG001|Outcome|Safety Analysis Set|All patients who have received at least 1 dose of study medication
11190649|NCT02127710|OG000|Outcome|c-MET Positive [600mg AZD6094 po]|All participants tested for the presence of c-MET mutations
11190650|NCT02127710|OG001|Outcome|c-MET Negative [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11373567|NCT02786394|BG000|Baseline|REACH Participant Course|"This study will run twice a week over 6 weeks with 6 REACH sessions and optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.~REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC."
11373568|NCT02786394|FG000|Participant Flow|REACH Participant Course|"This study will run twice a week over 6 weeks with 6 REACH sessions and optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.~REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC."
11373569|NCT02786394|OG000|Outcome|REACH Participant Course|"This study will run twice a week over 6 weeks with 6 REACH sessions and optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.~REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC."
11373570|NCT02786394|OG000|Outcome|REACH Participant Course|"This study will run twice a week over 6 weeks with 6 REACH sessions optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.~REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC."
11373571|NCT02786394|EG000|Reported Event|REACH Participant Course|"This study will run twice a week over 8 weeks with 6 REACH sessions 8 optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.~REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC."
11373572|NCT02588248|BG000|Baseline|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; with 0 mg of L-Methol)."
11373573|NCT02588248|BG001|Baseline|Peppermint Oil|"Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)~Ingredients:~16mL of peppermint oil (provided by the NowFoods® company)~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol)."
11373574|NCT02588248|BG002|Baseline|Total|Total of all reporting groups
11190651|NCT02127710|OG002|Outcome|c-MET Status Unknown [600mg AZD6094 po]|All participants were tested for the presence of c-MET mutations.
11190652|NCT02127710|OG003|Outcome|Total [600mg AZD6094 po]|All participants tested for the presence of c-MET mutations
11190653|NCT02127710|OG000|Outcome|Safety Analysis Set [600mg AZD6094 po]|All patients who have received at least 1 dose of study medication
11190654|NCT02127710|OG000|Outcome|Pharmacokinetic Analysis Set [600mg AZD6094 po]|All patients that received at least one dose of study medication and had evaluable PK data
11190655|NCT02127710|EG000|Reported Event|AZD6094 600 mg Per Day Orally|All patients who received at least one dose of study medication
11373575|NCT02588248|FG000|Participant Flow|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose =80 ml Solution B which contains 0 mg of L-Menthol)."
11373576|NCT02588248|FG001|Participant Flow|Peppermint Oil|"Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)~Ingredients:~16mL of peppermint oil (provided by the NowFoods® company)~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol)."
11373577|NCT02588248|OG000|Outcome|Peppermint Oil|"Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)~Ingredients:~16mL of peppermint oil (provided by the NowFoods® company)~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol)."
11373578|NCT02588248|OG001|Outcome|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)"
11373579|NCT02588248|OG000|Outcome|Peppermint Oil|"Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)~Ingredients:~16mL of peppermint oil (provided by the NowFoods® company)~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Mentol)."
11373580|NCT02588248|OG001|Outcome|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)."
11373581|NCT02588248|OG001|Outcome|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, 0 mg of L-Menthol)."
11190656|NCT02127723|BG000|Baseline|Macrolane|"Att subjects will be treated with Macrolane~Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite"
11373582|NCT02588248|OG001|Outcome|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, 0 mg of L-Methol)."
11373583|NCT02588248|OG001|Outcome|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B; 0mg of L- Menthol)."
11190657|NCT02127723|FG000|Participant Flow|Macrolane|"All subjects will be treated with Macrolane~Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite"
10850237|NCT00300755|OG002|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
10850238|NCT00300755|EG000|Reported Event|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
10850239|NCT00300755|EG001|Reported Event|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
10850240|NCT00300755|EG002|Reported Event|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
11376763|NCT02630459|OG001|Outcome|CHU Sub-Study: One 140 mg/mL AI/Pen|A subset of participants in the OLTP randomized to self-administer erenumab via one 140 mg/mL AI/pen on CHU sub-study day 1, day 29 and day 57.
11190658|NCT02127723|OG000|Outcome|Macrolane|"All subjects will be treated with Macrolane~Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite"
11190659|NCT02127723|EG000|Reported Event|Macrolane|"Att subjects will be treated with Macrolane~Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite"
11376764|NCT02630459|OG000|Outcome|OLTP: Erenumab 70 mg QM|Erenumab 70 mg SC QM in the OLTP (at the time of the event).
11376765|NCT02630459|OG001|Outcome|OLTP: Erenumab 140 mg QM|Erenumab 140 mg SC QM in the OLTP (at the time of the event).
10962860|NCT00868790|FG002|Participant Flow|MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
10962861|NCT00868790|FG003|Participant Flow|MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
11376766|NCT02630459|OG002|Outcome|OLTP: Total|Participants receiving erenumab 70 mg and/or 140 mg SC QM in the OLTP
11376767|NCT02630459|OG000|Outcome|OLTP: 70 mg SC QM (Only)|Participants who received only erenumab 70 mg SC QM in the OLTP
11376768|NCT02630459|OG001|Outcome|OLTP: 140 mg SC QM (Only)|Participants who received only erenumab 140 mg SC QM in the OLTP
11373584|NCT02588248|EG000|Reported Event|Peppermint Oil|"Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)~Ingredients:~16mL of peppermint oil (provided by the NowFoods® company)~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo)."
11373585|NCT02588248|EG001|Reported Event|Placebo|"Solution B) Placebo solution~Ingredients:~0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution~1L prepackage sterile water~2.6mL of undyed simethicone~Instructions to prepare:~Add tween and simethicone to sterile water. Then, shake vigorously.~Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe~Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo)."
11373586|NCT02535065|BG000|Baseline|Endovascular Graft|"The Zenith Low Profile AAA Endovascular Graft and ancillary components~Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair"
11373587|NCT02535065|FG000|Participant Flow|Endovascular Graft|"The Zenith Low Profile AAA Endovascular Graft and ancillary components~Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair"
11373588|NCT02535065|OG000|Outcome|Endovascular Graft|"The Zenith Low Profile AAA Endovascular Graft and ancillary components~Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair"
11373589|NCT02535065|EG000|Reported Event|Endovascular Graft|"The Zenith Low Profile AAA Endovascular Graft and ancillary components~Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair"
11373590|NCT02510885|BG000|Baseline|SD-OCT Angiography|"Study participants will undergo imaging of both eyes with the AngioVue unit (approx. 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.~AngioVue SD-OCT: OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE."
11373591|NCT02510885|FG000|Participant Flow|SD-OCT Angiography|"Study participants will undergo imaging of both eyes with the AngioVue unit (approx. 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.~AngioVue SD-OCT: OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE."
11373592|NCT02510885|OG000|Outcome|SD-OCT Angiography|"Study participants will undergo imaging of both eyes with the AngioVue unit (approx 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.~AngioVue SD-OCT: OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE."
11376769|NCT02630459|OG002|Outcome|OLTP: 70/140 mg SC QM (Both)|Participants who received both erenumab 70 mg and 140 mg SC QM in the OLTP
11373593|NCT02510885|EG000|Reported Event|SD-OCT Angiography|"Study participants will undergo imaging of both eyes with the AngioVue unit (approx. 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.~AngioVue SD-OCT: OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE."
11373594|NCT02451358|BG000|Baseline|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373595|NCT02451358|BG001|Baseline|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373596|NCT02451358|BG002|Baseline|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
11373597|NCT02451358|BG003|Baseline|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
11373598|NCT02451358|BG004|Baseline|Total|Total of all reporting groups
11373599|NCT02451358|FG000|Participant Flow|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373600|NCT02451358|FG001|Participant Flow|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373601|NCT02451358|FG002|Participant Flow|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
11373602|NCT02451358|FG003|Participant Flow|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
11373603|NCT02451358|OG000|Outcome|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373604|NCT02451358|OG001|Outcome|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373605|NCT02451358|OG002|Outcome|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
11373606|NCT02451358|OG003|Outcome|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
11373607|NCT02451358|EG000|Reported Event|Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months|Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373608|NCT02451358|EG001|Reported Event|Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years|Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
11373609|NCT02451358|EG002|Reported Event|Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years|Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
11373610|NCT02451358|EG003|Reported Event|Quadrivalent Influenza Vaccine Group 4: >=18 Years|Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
11373611|NCT02268175|BG000|Baseline|ARM 1|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373612|NCT02268175|BG001|Baseline|ARM 2|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373613|NCT02268175|BG002|Baseline|Total|Total of all reporting groups
11373614|NCT02268175|FG000|Participant Flow|Enzalutamide + Abiraterone + Prednisone + Leuprolide|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373615|NCT02268175|FG001|Participant Flow|Enzalutamide + Leuprolide|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373616|NCT02268175|OG000|Outcome|ARM 1|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373617|NCT02268175|OG001|Outcome|ARM 2|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373618|NCT02268175|EG000|Reported Event|ARM 1|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373619|NCT02268175|EG001|Reported Event|ARM 2|"Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum.~Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months."
11373620|NCT02178709|BG000|Baseline|FOLFIRINOX|"FOLFIRINOX consists of the following combination of drugs:~Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle~Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle~Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.~5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle."
11373621|NCT02178709|FG000|Participant Flow|FOLFIRINOX|"FOLFIRINOX consists of the following combination of drugs:~Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle~Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle~Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.~5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle."
11373622|NCT02178709|OG000|Outcome|FOLFIRINOX|"FOLFIRINOX consists of the following combination of drugs:~Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle~Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle~Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.~5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle."
11373623|NCT02178709|EG000|Reported Event|FOLFIRINOX|"FOLFIRINOX consists of the following combination of drugs:~Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle~Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle~Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle~5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.~5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle."
11373624|NCT02163681|BG000|Baseline|Hyperpolarized Helium 3 MRI of the Chest|"Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.~Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation."
11373625|NCT02163681|FG000|Participant Flow|Hyperpolarized Helium 3 MRI of the Chest|"Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.~Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation."
11373626|NCT02163681|OG000|Outcome|Hyperpolarized Helium 3 MRI of the Chest|"Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.~Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation."
11373627|NCT02163681|EG000|Reported Event|Hyperpolarized Helium 3 MRI of the Chest|"Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.~Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation."
11373628|NCT01980017|BG000|Baseline|Wait-Listed Control Group|Usual care for smoking cessation
11373629|NCT01980017|BG001|Baseline|Ottawa Model for Smoking Cessation|Ottawa Model for Smoking Cessation
11373630|NCT01980017|BG002|Baseline|Total|Total of all reporting groups
11373631|NCT01980017|FG000|Participant Flow|Wait-Listed Control Group|Usual care for smoking cessation
11373632|NCT01980017|FG001|Participant Flow|Ottawa Model for Smoking Cessation|Ottawa Model for Smoking Cessation
11373633|NCT01980017|OG000|Outcome|Wait-Listed Control Group|Usual care for smoking cessation
11373634|NCT01980017|OG001|Outcome|Ottawa Model for Smoking Cessation|Ottawa Model for Smoking Cessation
11373635|NCT01980017|OG000|Outcome|Implementation Cost - Patient|Per-patient cost to implement program
11373636|NCT01980017|OG001|Outcome|Implementation Cost - Patient Not Ready to Quit|Per-patient cost for those who are not ready to quit smoking
11373637|NCT01980017|OG000|Outcome|Implementation Costs - Clinic|The cost to implement and maintain the smoking cessation intervention at the clinic level.
11373638|NCT01980017|EG000|Reported Event|Wait-Listed Control Group|Usual care for smoking cessation
11373639|NCT01980017|EG001|Reported Event|Ottawa Model for Smoking Cessation|Ottawa Model for Smoking Cessation
11373640|NCT01890759|BG000|Baseline|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373641|NCT01890759|BG001|Baseline|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373642|NCT01890759|BG002|Baseline|Total|Total of all reporting groups
11373643|NCT01890759|FG000|Participant Flow|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373644|NCT01890759|FG001|Participant Flow|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373645|NCT01890759|OG000|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
10850241|NCT00300781|BG000|Baseline|Neratinib 240, Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
10850242|NCT00300781|BG001|Baseline|Neratinib 240, No Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
10850243|NCT00300781|BG002|Baseline|Total|Total of all reporting groups
11373646|NCT01890759|OG001|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373647|NCT01890759|EG000|Reported Event|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373648|NCT01890759|EG001|Reported Event|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
11373649|NCT01855867|BG000|Baseline|Stribild|"Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV~Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)"
11373650|NCT01855867|FG000|Participant Flow|Stribild|"Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV~Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)"
11373651|NCT01855867|OG000|Outcome|Stribild|"Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV~Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)"
11373652|NCT01855867|OG000|Outcome|Stribild|Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
11373653|NCT01855867|EG000|Reported Event|Stribild|"Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV~Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)"
11373654|NCT01721746|BG000|Baseline|Nivolumab|Nivolumab 3 mg/kg IV over 60 minutes Q2W
11373655|NCT01721746|BG001|Baseline|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W
11373656|NCT01721746|BG002|Baseline|Total|Total of all reporting groups
11373657|NCT01721746|FG000|Participant Flow|Nivolumab|Nivolumab 3 mg/kg IV over 60 minutes Q2W
10850244|NCT00300781|FG000|Participant Flow|Neratinib 240, Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen, in participants with prior trastuzumab treatment.
11373658|NCT01721746|FG001|Participant Flow|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W
11373659|NCT01721746|OG000|Outcome|Nivolumab|Nivolumab 3 mg/kg IV over 60 minutes Q2W
11373660|NCT01721746|OG001|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W
11373661|NCT01721746|OG001|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W
11373662|NCT01721746|EG000|Reported Event|Nivolumab|Nivolumab 3 mg/kg IV over 60 minutes Q2W
11373663|NCT01721746|EG001|Reported Event|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W
11373664|NCT01705977|BG000|Baseline|Placebo|Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373665|NCT01705977|BG001|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373666|NCT01705977|BG002|Baseline|Total|Total of all reporting groups
11373667|NCT01705977|FG000|Participant Flow|Placebo|Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373668|NCT01705977|FG001|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373669|NCT01705977|OG000|Outcome|Placebo|Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373670|NCT01705977|OG001|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373671|NCT01705977|EG000|Reported Event|Placebo|Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373672|NCT01705977|EG001|Reported Event|Belimumab 10 mg/kg|Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment.
11373673|NCT01587040|BG000|Baseline|SAR245408: Monotherapy|Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
11373674|NCT01587040|BG001|Baseline|SAR245408: Combination Regimen|Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
11373675|NCT01587040|BG002|Baseline|SAR245409: Monotherapy|Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
11373676|NCT01587040|BG003|Baseline|SAR245409: Combination Regimen|Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
11373677|NCT01587040|BG004|Baseline|Total|Total of all reporting groups
11373678|NCT01587040|FG000|Participant Flow|SAR245408: Monotherapy|Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
11373679|NCT01587040|FG001|Participant Flow|SAR245408: Combination Regimen|Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
11373680|NCT01587040|FG002|Participant Flow|SAR245409: Monotherapy|Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
11373681|NCT01587040|FG003|Participant Flow|SAR245409: Combination Regimen|Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
11373682|NCT01587040|OG000|Outcome|SAR245408: Monotherapy|Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
11373683|NCT01587040|OG001|Outcome|SAR245408: Combination Regimen|Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
11373684|NCT01587040|OG002|Outcome|SAR245409: Monotherapy|Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
11373685|NCT01587040|OG003|Outcome|SAR245409: Combination Regimen|Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
11373686|NCT01587040|EG000|Reported Event|SAR245408: Monotherapy|Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
11373687|NCT01587040|EG001|Reported Event|SAR245408: Combination Regimen|Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
11373688|NCT01587040|EG002|Reported Event|SAR245409: Monotherapy|Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
11373689|NCT01587040|EG003|Reported Event|SAR245409: Combination Regimen|Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
11373690|NCT01293682|BG000|Baseline|Calcitriol|"Calcitriol 45mcg/week~Calcitriol: In pill form, 45 micrograms once a week for 12 weeks"
11373691|NCT01293682|FG000|Participant Flow|Calcitriol|"Calcitriol 45mcg/week~Calcitriol: In pill form, 45 micrograms once a week for 12 weeks"
11373692|NCT01293682|OG000|Outcome|Calcitriol|"Calcitriol 45mcg/week~Calcitriol: In pill form, 45 micrograms once a week for 12 weeks"
11373693|NCT01293682|EG000|Reported Event|Calcitriol|"Calcitriol 45mcg/week~Calcitriol: In pill form, 45 micrograms once a week for 12 weeks"
11373694|NCT01254409|BG000|Baseline|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373695|NCT01254409|BG001|Baseline|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373696|NCT01254409|BG002|Baseline|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373697|NCT01254409|BG003|Baseline|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373698|NCT01254409|BG004|Baseline|Total|Total of all reporting groups
11373699|NCT01254409|FG000|Participant Flow|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373700|NCT01254409|FG001|Participant Flow|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373701|NCT01254409|FG002|Participant Flow|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373702|NCT01254409|FG003|Participant Flow|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373703|NCT01254409|OG000|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373704|NCT01254409|OG001|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373705|NCT01254409|OG002|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373706|NCT01254409|OG003|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373707|NCT01254409|OG000|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373708|NCT01254409|OG001|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373709|NCT01254409|OG002|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373710|NCT01254409|EG000|Reported Event|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373711|NCT01254409|EG001|Reported Event|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373712|NCT01254409|EG002|Reported Event|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373713|NCT01254409|EG003|Reported Event|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
11373714|NCT01253161|BG000|Baseline|Pasireotide LAR Treatment|"The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.~Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11373715|NCT01253161|FG000|Participant Flow|Pasireotide LAR Treatment|"The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.~Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11373716|NCT01253161|OG000|Outcome|Pasireotide LAR Treatment|"The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.~Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11373717|NCT01253161|EG000|Reported Event|Pasireotide LAR Treatment|"The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.~Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11373718|NCT01084252|BG000|Baseline|Phase 1:Isatuximab <=1 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373719|NCT01084252|BG001|Baseline|Phase 1: Isatuximab 3mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373720|NCT01084252|BG002|Baseline|Phase 1: Isatuximab 5 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373721|NCT01084252|BG003|Baseline|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373722|NCT01084252|BG004|Baseline|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11376770|NCT02630459|OG003|Outcome|OLTP: Total|Participants who received erenumab 70 mg and/or 140 mg SC QM in the OLTP
11376771|NCT02630459|EG000|Reported Event|DBTP: Placebo|Placebo SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11373723|NCT01084252|BG005|Baseline|Phase 1: Isatuximab 10 mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373724|NCT01084252|BG006|Baseline|Phase 1: Isatuximab 20 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373725|NCT01084252|BG007|Baseline|Phase 1: Isatuximab 20 mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373726|NCT01084252|BG008|Baseline|Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373727|NCT01084252|BG009|Baseline|Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373728|NCT01084252|BG010|Baseline|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Q4W, i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373729|NCT01084252|BG011|Baseline|Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W|Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1,8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
11373730|NCT01084252|BG012|Baseline|Phase 2 Stage 2: Isatuximab Alone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373731|NCT01084252|BG013|Baseline|Phase 2 Stage 2: Isatuximab + Dexamethasone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for <75 years of age; 20 mg/day for >=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373732|NCT01084252|BG014|Baseline|Total|Total of all reporting groups
11373733|NCT01084252|FG000|Participant Flow|Phase1: Isatuximab <=1 mg/kg Every 2 Weeks (Q2W)|Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373734|NCT01084252|FG001|Participant Flow|Phase 1: Isatuximab 3mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373735|NCT01084252|FG002|Participant Flow|Phase 1: Isatuximab 5 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373736|NCT01084252|FG003|Participant Flow|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373737|NCT01084252|FG004|Participant Flow|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373738|NCT01084252|FG005|Participant Flow|Phase 1: Isatuximab 10 mg/kg Every Week (QW)|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373739|NCT01084252|FG006|Participant Flow|Phase 1: Isatuximab 20 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373740|NCT01084252|FG007|Participant Flow|Phase 1: Isatuximab 20 mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11376772|NCT02630459|EG001|Reported Event|DBTP: Erenumab 28 mg QM|Erenumab 28 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11240515|NCT02480114|OG000|Outcome|Arm I Standard of Care|"Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.~Educational Intervention: Undergo oral care and pain management education session~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11240516|NCT02480114|OG001|Outcome|Arm II Standard of Care Plus Gabapentin|"Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.~Educational Intervention: Undergo oral care and pain management education session~Gabapentin: Given PO~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11240517|NCT02480114|EG000|Reported Event|Arm I Standard of Care|"Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.~Educational Intervention: Undergo oral care and pain management education session~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11373741|NCT01084252|FG008|Participant Flow|Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373742|NCT01084252|FG009|Participant Flow|Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373743|NCT01084252|FG010|Participant Flow|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373744|NCT01084252|FG011|Participant Flow|Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W|Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
11373745|NCT01084252|FG012|Participant Flow|Phase 2 Stage 2: Isatuximab Alone|Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373746|NCT01084252|FG013|Participant Flow|Phase 2 Stage 2: Isatuximab + Dexamethasone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373747|NCT01084252|OG000|Outcome|Phase 1:Isatuximab <=1 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373748|NCT01084252|OG001|Outcome|Phase 1: Isatuximab 3mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373749|NCT01084252|OG002|Outcome|Phase 1: Isatuximab 5mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373750|NCT01084252|OG003|Outcome|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373751|NCT01084252|OG004|Outcome|Phase 1: Isatuximab 10 mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373752|NCT01084252|OG005|Outcome|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373753|NCT01084252|OG006|Outcome|Phase 1: Isatuximab 20mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373754|NCT01084252|OG000|Outcome|Phase 1: Isatuximab <=1mg/kg Q2W|Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373755|NCT01084252|OG004|Outcome|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11190660|NCT02127892|BG000|Baseline|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
11190661|NCT02127892|BG001|Baseline|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
11373756|NCT01084252|OG005|Outcome|Phase 1: Isatuximab 10 mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
10962862|NCT00868790|FG004|Participant Flow|PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
10962863|NCT00868790|FG005|Participant Flow|MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
11190662|NCT02127892|BG002|Baseline|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
11373757|NCT01084252|OG006|Outcome|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)..
11373758|NCT01084252|OG007|Outcome|Phase 1: Isatuximab 20mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11190663|NCT02127892|BG003|Baseline|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
11190664|NCT02127892|BG004|Baseline|Total|Total of all reporting groups
11190665|NCT02127892|FG000|Participant Flow|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
11190666|NCT02127892|FG001|Participant Flow|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
11373759|NCT01084252|OG000|Outcome|Phase 2 Stage 1a: Isatuximab 3 mg/kg|Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373760|NCT01084252|OG001|Outcome|Phase 2 Stage 1a: Isatuximab 10 mg/kg|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373761|NCT01084252|OG002|Outcome|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W and Then Q4W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Q4W, i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373762|NCT01084252|OG003|Outcome|Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W|Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11376773|NCT02630459|EG002|Reported Event|DPTP: Erenumab 70 mg QM|Erenumab 70 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376774|NCT02630459|EG003|Reported Event|DBTP: Erenumab 140 mg QM|Erenumab 140 mg SC on day 1 and at weeks 4, 8, 12, 16, and 20 in the DBTP.
11376775|NCT02630459|EG004|Reported Event|OLTP: Erenumab 70 mg QM|Erenumab 70 mg SC QM in the OLTP (at the time of the event).
10849992|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10962864|NCT00868790|FG006|Participant Flow|MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
10962865|NCT00868790|FG007|Participant Flow|MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
10962866|NCT00868790|FG008|Participant Flow|PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
10962867|NCT00868790|FG009|Participant Flow|MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
10962868|NCT00868790|FG010|Participant Flow|MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
10962869|NCT00868790|FG011|Participant Flow|MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
11373763|NCT01084252|OG000|Outcome|Phase 2 Stage 2: Isatuximab Alone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373764|NCT01084252|OG001|Outcome|Phase 2 Stage 2: Isatuximab + Dexamethasone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion(40 mg/day for <75 years of age; 20 mg/day for >=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373765|NCT01084252|OG000|Outcome|Phase 1: Isatuximab 0.3 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 0.3 mg/kg, as IV infusion on Day 1of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373766|NCT01084252|OG001|Outcome|Phase 1: Isatuximab 1 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373767|NCT01084252|OG002|Outcome|Phase 1: Isatuximab 3mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373768|NCT01084252|OG003|Outcome|Phase 1: Isatuximab 5mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373769|NCT01084252|OG004|Outcome|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373770|NCT01084252|OG005|Outcome|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373771|NCT01084252|OG006|Outcome|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11376776|NCT02630459|EG005|Reported Event|OLTP: Erenumab 140 mg QM|Erenumab 140 mg SC QM in the OLTP (at the time of the event).
11376777|NCT02630459|EG006|Reported Event|OLTP Total: Erenumab 70/140 mg QM|Erenumab 70 mg and/or 140 mg SC QM in the OLTP.
10962870|NCT00868790|FG012|Participant Flow|PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)|Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
11190667|NCT02127892|FG002|Participant Flow|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
11373772|NCT01084252|OG007|Outcome|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373773|NCT01084252|OG008|Outcome|Phase 1: Isatuximab 20mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373774|NCT01084252|OG006|Outcome|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)
11373775|NCT01084252|OG000|Outcome|Phase 1: Isatuximab 1 mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373776|NCT01084252|OG002|Outcome|Phase 1: 5mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373777|NCT01084252|OG005|Outcome|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373778|NCT01084252|OG003|Outcome|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma , received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373779|NCT01084252|OG004|Outcome|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373780|NCT01084252|OG005|Outcome|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373781|NCT01084252|OG000|Outcome|Phase 1:Isatuximab <=1 mg/kg Q2W|"Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure:~120 weeks)."
11373782|NCT01084252|OG000|Outcome|Phase 1: Isatuximab 1mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373783|NCT01084252|OG001|Outcome|Phase 1: Isatuximab 5mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373784|NCT01084252|OG002|Outcome|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373785|NCT01084252|OG003|Outcome|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373786|NCT01084252|OG004|Outcome|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373787|NCT01084252|OG005|Outcome|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)
11373788|NCT01084252|OG004|Outcome|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373789|NCT01084252|OG000|Outcome|Phase 1: Isatuximab|All participants who were enrolled in Phase 1 and received Isatuximab.
11376778|NCT02630459|EG007|Reported Event|CHU Sub-Study: Two Erenumab 70 mg/mL AI/Pens|Self-administered erenumab via two 70 mg/mL AI/pens on day 1, day 29 and day 57 of the CHU sub-study.
11190668|NCT02127892|FG003|Participant Flow|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
11190669|NCT02127892|OG000|Outcome|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
11190670|NCT02127892|OG001|Outcome|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
11373790|NCT01084252|OG000|Outcome|Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373791|NCT01084252|OG001|Outcome|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373792|NCT01084252|OG002|Outcome|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Q4W, i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373793|NCT01084252|OG003|Outcome|Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W|Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
11373794|NCT01084252|OG001|Outcome|Phase 2 Stage 2: Isatuximab + Dexamethasone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for <75 years of age; 20 mg/day for >=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373795|NCT01084252|EG000|Reported Event|Phase 1: Isatuximab 1mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11190671|NCT02127892|OG002|Outcome|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
11190672|NCT02127892|OG003|Outcome|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
11190673|NCT02127892|EG000|Reported Event|Unrelated BM With T Cell Depletion|"Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles.~unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted)."
11190674|NCT02127892|EG001|Reported Event|Unrelated Cord Blood|"Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles).~unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP."
11190675|NCT02127892|EG002|Reported Event|Haplo BM With T Cell Depletion|"If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors.~haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation."
11190676|NCT02127892|EG003|Reported Event|Unrelated PBSC With T Cell Depletion|"The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed.~unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation."
11190677|NCT02127931|BG000|Baseline|All Participants|College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
11190678|NCT02127931|FG000|Participant Flow|All Participants|College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
11373796|NCT01084252|EG001|Reported Event|Phase 1: Isatuximab 3mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373797|NCT01084252|EG002|Reported Event|Phase 1: Isatuximab 5mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11190679|NCT02127931|OG000|Outcome|All Participants|College students recruited for study Groundskeeper: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
11190680|NCT02127931|OG000|Outcome|All Participants|College students and participants requested to complete CPT
11190681|NCT02127931|EG000|Reported Event|College Students and Participants Requested to Complete CPT|"Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD.~Groundskeeper for ADHD group: Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD."
11373798|NCT01084252|EG003|Reported Event|Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373799|NCT01084252|EG004|Reported Event|Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)|Participants with CD38+ HM along with participants with high risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373800|NCT01084252|EG005|Reported Event|Phase 1: Isatuximab 10mg/kg QW|Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373801|NCT01084252|EG006|Reported Event|Phase 1: Isatuximab 20mg/kg Q2W|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373802|NCT01084252|EG007|Reported Event|Phase 1: Isatuximab 20mg/kg QW|Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
11373803|NCT01084252|EG008|Reported Event|Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11373804|NCT01084252|EG009|Reported Event|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11190682|NCT02127970|BG000|Baseline|Single-Dose Dalbavancin|Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
11190683|NCT02127970|BG001|Baseline|Two-Dose Dalbavancin|Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
11190684|NCT02127970|BG002|Baseline|Total|Total of all reporting groups
11190685|NCT02127970|FG000|Participant Flow|Single-Dose Dalbavancin|Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
11190686|NCT02127970|FG001|Participant Flow|Two-Dose Dalbavancin|Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
11190687|NCT02127970|OG000|Outcome|Single-Dose Dalbavancin|Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
11373805|NCT01084252|EG010|Reported Event|Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W|Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
11373806|NCT01084252|EG011|Reported Event|Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W|Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Day 1 of each 28-days cycle until Unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
11376779|NCT02630459|EG008|Reported Event|CHU Sub-Study: One Erenumab 140 mg/mL AI/Pen|Self-administered erenumab via one 140 mg/mL AI/pen on day 1, day 29 and day 57 of the CHU sub-study.
11190688|NCT02127970|OG001|Outcome|Two-Dose Dalbavancin|Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
11373807|NCT01084252|EG012|Reported Event|Phase 2 Stage 2: Isatuximab Alone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373808|NCT01084252|EG013|Reported Event|Phase 2 Stage 2: Isatuximab + Dexamethasone|Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion tablet or as IV infusion (40 mg/day for <75 years of age; 20 mg/day for >=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
11373809|NCT00867321|BG000|Baseline|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
11373810|NCT00867321|BG001|Baseline|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
11373811|NCT00867321|BG002|Baseline|All Phase I Patients|This includes all patients who participated in the phase I dose escalation portion of the trial.
11373812|NCT00867321|BG003|Baseline|Total|Total of all reporting groups
11373813|NCT00867321|FG000|Participant Flow|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
11373814|NCT00867321|FG001|Participant Flow|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
11373815|NCT00867321|FG002|Participant Flow|Phase I: Dose Level 0|"Patients receive:> > Oral 400 mg BID Sorafenib on days 1-28.>~> 1.25 mg/kg Bevacizumab IV on days 1, 15."
11373816|NCT00867321|FG003|Participant Flow|Phase I: Dose Level -1|"Patients receive:> > Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
11373817|NCT00867321|FG004|Participant Flow|Phase I: Dose Level -2a|"Patients receive:> > Oral 200 mg BID Sorafenib days 1-28>~> 2.5 mg/kg Bevacizumab IV on days 1, 15"
11373818|NCT00867321|FG005|Participant Flow|Phase I: Dose Level -2|"Patients receive:> > Oral 200 mg BID Sorafenib days 1-28>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
11373819|NCT00867321|OG000|Outcome|Phase I: Dose Level 0|"Patients receive:~>~> Oral 400 mg BID Sorafenib on days 1-28.~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15."
11373820|NCT00867321|OG001|Outcome|Phase I: Dose Level -1|"Patients receive:~>~> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
11373821|NCT00867321|OG002|Outcome|Phase I: Dose Level -2a (Maximum Tolerated Dose)|"Patients receive:~>~> Oral 200 mg BID Sorafenib days 1-28~>~> 2.5 mg/kg Bevacizumab IV on days 1, 15"
11373822|NCT00867321|OG003|Outcome|Phase I: Dose Level -2|"Patients receive:~>~> Oral 200 mg BID Sorafenib days 1-28~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
11373823|NCT00867321|OG000|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
11373824|NCT00867321|OG001|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
11373825|NCT00867321|OG000|Outcome|All Patients|Due to lack of accrual Overall Survival was estimated using all patients
11373826|NCT00867321|EG000|Reported Event|Phase I: Dose Level 0|"Patients receive:~Oral 400 mg BID Sorafenib on days 1-28.~1.25 mg/kg Bevacizumab IV on days 1, 15"
11373827|NCT00867321|EG001|Reported Event|Phase I: Dose Level -1|"Patients receive:~Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days~1.25 mg/kg Bevacizumab IV on days 1, 15"
11373828|NCT00867321|EG002|Reported Event|Phase I: Dose Level -2a|"Patients receive:~Oral 200 mg BID Sorafenib days 1-28~2.5 mg/kg Bevacizumab IV on days 1, 15"
11373829|NCT00867321|EG003|Reported Event|Phase I: Dose Level -2|"Patients receive:~Oral 200 mg BID Sorafenib days 1-28~1.25 mg/kg Bevacizumab IV on days 1, 15"
11373830|NCT00867321|EG004|Reported Event|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
11373831|NCT00867321|EG005|Reported Event|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
11373832|NCT00728962|BG000|Baseline|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
11373833|NCT00728962|FG000|Participant Flow|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
11373834|NCT00728962|OG000|Outcome|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
11373835|NCT00728962|EG000|Reported Event|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
11373836|NCT00728754|BG000|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373837|NCT00728754|BG001|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
11373838|NCT00728754|BG002|Baseline|Total|Total of all reporting groups
11373839|NCT00728754|FG000|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373840|NCT00728754|FG001|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
11373841|NCT00728754|OG000|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373842|NCT00728754|OG001|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
11373843|NCT00728754|EG000|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373844|NCT00728754|EG001|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
11373845|NCT00723944|BG000|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373846|NCT00723944|BG001|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
11373847|NCT00723944|BG002|Baseline|Total|Total of all reporting groups
11373848|NCT00723944|FG000|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373849|NCT00723944|FG001|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
11373850|NCT00723944|OG000|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373851|NCT00723944|OG001|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
11373852|NCT00723944|EG000|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
11373853|NCT00723944|EG001|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
11373854|NCT00467142|BG000|Baseline|Folfiri and Bevacizumab|"Premedication = Dexchlorpheniramine, 5 mg in slow Direct IntraVeinous (DIV) on D1.~FOLFIRI (simplified LV5FU2 + irinotecan):~Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes.~LV5FU2, in its so-called simplified version, will be administered as follows L-folinic acid, as a 2-hour intravenous infusion, at a dose of 200 mg/m², on Day 1, in 500 mL of 5% glucose solution, concomitantly with the irinotecan infusion via a Y-tube, followed by 5 Fluorouracil (5 FU), intravenous bolus, at a dose of 400 mg/m² on D1, followed by 5 Fluorouracil (5 FU) as a 46-hour continuous infusion at a dose of 2400 mg/m² from D1 to D3, either in 1000 mL of 5% glucose solution, or in an electric syringe or pump dispenser~Bevacizumab (Avastin®): 5 mg/kg IV infusion in 100 mL of 0.9% saline over 90 minutes for the first infusion, then 60 minutes for the second infusion if tolerated, and 30 minutes for subsequent infusions if tolerated.~bevacizumab~fluorouracil~irinotecan hydrochloride~leucovorin calcium~polymorphism analysis"
11373855|NCT00467142|FG000|Participant Flow|Folfiri and Bevacizumab|"Premedication = Dexchlorpheniramine, 5 mg in slow Direct IntraVeinous (DIV) on D1.~FOLFIRI (simplified LV5FU2 + irinotecan):~Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes.~LV5FU2, in its so-called simplified version, will be administered as follows L-folinic acid, as a 2-hour intravenous infusion, at a dose of 200 mg/m², on Day 1, in 500 mL of 5% glucose solution, concomitantly with the irinotecan infusion via a Y-tube, followed by 5 Fluorouracil (5 FU), intravenous bolus, at a dose of 400 mg/m² on D1, followed by 5 Fluorouracil (5 FU) as a 46-hour continuous infusion at a dose of 2400 mg/m² from D1 to D3, either in 1000 mL of 5% glucose solution, or in an electric syringe or pump dispenser~Bevacizumab (Avastin®): 5 mg/kg IV infusion in 100 mL of 0.9% saline over 90 minutes for the first infusion, then 60 minutes for the second infusion if tolerated, and 30 minutes for subsequent infusions if tolerated.~bevacizumab~fluorouracil~irinotecan hydrochloride~leucovorin calcium~polymorphism analysis"
11373856|NCT00467142|OG000|Outcome|Folfiri and Bevacizumab|"Premedication = Dexchlorpheniramine, 5 mg in slow Direct IntraVeinous (DIV) on D1.~FOLFIRI (simplified LV5FU2 + irinotecan):~Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes.~LV5FU2, in its so-called simplified version, will be administered as follows L-folinic acid, as a 2-hour intravenous infusion, at a dose of 200 mg/m², on Day 1, in 500 mL of 5% glucose solution, concomitantly with the irinotecan infusion via a Y-tube, followed by 5 Fluorouracil (5 FU), intravenous bolus, at a dose of 400 mg/m² on D1, followed by 5 Fluorouracil (5 FU) as a 46-hour continuous infusion at a dose of 2400 mg/m² from D1 to D3, either in 1000 mL of 5% glucose solution, or in an electric syringe or pump dispenser~Bevacizumab (Avastin®): 5 mg/kg IV infusion in 100 mL of 0.9% saline over 90 minutes for the first infusion, then 60 minutes for the second infusion if tolerated, and 30 minutes for subsequent infusions if tolerated.~bevacizumab~fluorouracil~irinotecan hydrochloride~leucovorin calcium~polymorphism analysis"
11373857|NCT00467142|EG000|Reported Event|Folfiri and Bevacizumab|"Premedication = Dexchlorpheniramine, 5 mg in slow Direct IntraVeinous (DIV) on D1.~FOLFIRI (simplified LV5FU2 + irinotecan):~Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes.~LV5FU2, in its so-called simplified version, will be administered as follows L-folinic acid, as a 2-hour intravenous infusion, at a dose of 200 mg/m², on Day 1, in 500 mL of 5% glucose solution, concomitantly with the irinotecan infusion via a Y-tube, followed by 5 Fluorouracil (5 FU), intravenous bolus, at a dose of 400 mg/m² on D1, followed by 5 Fluorouracil (5 FU) as a 46-hour continuous infusion at a dose of 2400 mg/m² from D1 to D3, either in 1000 mL of 5% glucose solution, or in an electric syringe or pump dispenser~Bevacizumab (Avastin®): 5 mg/kg IV infusion in 100 mL of 0.9% saline over 90 minutes for the first infusion, then 60 minutes for the second infusion if tolerated, and 30 minutes for subsequent infusions if tolerated.~bevacizumab~fluorouracil~irinotecan hydrochloride~leucovorin calcium~polymorphism analysis"
11376780|NCT02630459|EG009|Reported Event|CHU Sub-Study Total|Self-administered erenumab via two 70 mg/mL AI/pens or one 140 mg/mL AI/pen on day 1, day 29 and day 57 of the CHU sub-study.
11376781|NCT02586857|BG000|Baseline|Cohort 1|Acalabrutinib 200mg administered orally (PO) twice daily (BID).
11376782|NCT02586857|BG001|Baseline|Cohort 2|Acalabrutinib 400mg PO (QD).
11376783|NCT02586857|BG002|Baseline|Total|Total of all reporting groups
11376784|NCT02586857|FG000|Participant Flow|Cohort 1 - Acalabrutinib|Acalabrutinib 200mg PO BID.
11376785|NCT02586857|FG001|Participant Flow|Cohort 2 - Acalabrutinib|Acalabrutinib 400mg PO QD.
11376786|NCT02586857|OG000|Outcome|Cohort 1|Acalabrutinib 200mg by PO BID.
11376787|NCT02586857|OG001|Outcome|Cohort 2|Acalabrutinib 400mg by PO QD.
11376788|NCT02586857|EG000|Reported Event|Cohort 1|Acalabrutinib 200mg administered orally (PO) twice daily (BID).
11373858|NCT04878172|BG000|Baseline|TempSure Firm Day 0 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373859|NCT04878172|BG001|Baseline|TempSure Firm Day 10 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373860|NCT04878172|BG002|Baseline|TempSure Firm Day 20 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373861|NCT04878172|BG003|Baseline|TempSure Firm Day 30 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373862|NCT04878172|BG004|Baseline|Total|Total of all reporting groups
11373863|NCT04878172|FG000|Participant Flow|TempSure Firm Day 0 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373864|NCT04878172|FG001|Participant Flow|TempSure Firm Day 10 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373865|NCT04878172|FG002|Participant Flow|TempSure Firm Day 20 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
10962871|NCT00868790|FG013|Participant Flow|METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)|Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
10962872|NCT00868790|OG000|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
11373866|NCT04878172|FG003|Participant Flow|TempSure Firm Day 30 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373867|NCT04878172|OG000|Outcome|TempSure Firm Day 0 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373868|NCT04878172|OG000|Outcome|TempSure Firm Day 10 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373869|NCT04878172|OG000|Outcome|TempSure Firm Day 20 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373870|NCT04878172|OG000|Outcome|TempSure Firm Day 30 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373871|NCT04878172|EG000|Reported Event|TempSure Firm Day 0 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373872|NCT04878172|EG001|Reported Event|TempSure Firm Day 10 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373873|NCT04878172|EG002|Reported Event|TempSure Firm Day 20 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373874|NCT04878172|EG003|Reported Event|TempSure Firm Day 30 Biopsy Group|"Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.~TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis."
11373875|NCT04671017|BG000|Baseline|Low Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373876|NCT04671017|BG001|Baseline|Medium Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373877|NCT04671017|BG002|Baseline|High Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373878|NCT04671017|BG003|Baseline|Total|Total of all reporting groups
11373879|NCT04671017|FG000|Participant Flow|Low Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373880|NCT04671017|FG001|Participant Flow|Medium Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373881|NCT04671017|FG002|Participant Flow|High Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373882|NCT04671017|OG000|Outcome|Low Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11376789|NCT02586857|EG001|Reported Event|Cohort 2 - Acalabrutinib|Acalabrutinib 400mg PO (QD)
11373883|NCT04671017|OG001|Outcome|Medium Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373884|NCT04671017|OG002|Outcome|High Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373885|NCT04671017|EG000|Reported Event|Low Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373886|NCT04671017|EG001|Reported Event|Medium Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373887|NCT04671017|EG002|Reported Event|High Dose: VLA2001|VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
11373888|NCT04557371|BG000|Baseline|Developmental Serum|The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.
11373889|NCT04557371|BG001|Baseline|Developmental Lotion|The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.
11373890|NCT04557371|BG002|Baseline|Developmental Cream|The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
11373891|NCT04557371|BG003|Baseline|Total|Total of all reporting groups
11373892|NCT04557371|FG000|Participant Flow|Developmental Serum|The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.
11373893|NCT04557371|FG001|Participant Flow|Developmental Lotion|The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.
11373894|NCT04557371|FG002|Participant Flow|Developmental Cream|The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
11373895|NCT04557371|OG000|Outcome|Developmental Serum|The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.
11373896|NCT04557371|OG001|Outcome|Developmental Lotion|The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.
11373897|NCT04557371|OG002|Outcome|Developmental Cream|The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
11373898|NCT04557371|EG000|Reported Event|Developmental Serum|The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.
10962873|NCT00868790|OG001|Outcome|MK-3577 AM|Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
10962874|NCT00868790|OG002|Outcome|MK-3577 PM|Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
10962875|NCT00868790|OG003|Outcome|MK-3577 BID|Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
11373899|NCT04557371|EG001|Reported Event|Developmental Lotion|The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.
11373900|NCT04557371|EG002|Reported Event|Developmental Cream|The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
11376790|NCT02575976|BG000|Baseline|Comprehensive CR|"education and exercise-based cardiac rehabilitation~comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)"
11376791|NCT02575976|BG001|Baseline|Exercise-based CR|"Exercise-based cardiac rehabilitation~exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions."
11376792|NCT02575976|BG002|Baseline|Wait List Control|"no cardiac rehabilitation~wait list control: No cardiac rehabilitation."
11376793|NCT02575976|BG003|Baseline|Total|Total of all reporting groups
10962876|NCT00868790|OG004|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
11190689|NCT02127970|EG000|Reported Event|Single-Dose Dalbavancin|Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
11190690|NCT02127970|EG001|Reported Event|Two-Dose Dalbavancin|Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl <30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl <30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
11190691|NCT02128074|BG000|Baseline|KRX-0502|"KRX-0502 (ferric citrate)~KRX-0502: 1g tablets of KRX-0502"
11376794|NCT02575976|FG000|Participant Flow|Comprehensive CR|"education and exercise-based cardiac rehabilitation~comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)"
10962877|NCT00868790|OG001|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
10962878|NCT00868790|OG002|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
10962879|NCT00868790|OG003|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
10962880|NCT00868790|OG004|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
10962881|NCT00868790|EG000|Reported Event|Placebo|Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
10962882|NCT00868790|EG001|Reported Event|MK-3577 AM|Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
10962883|NCT00868790|EG002|Reported Event|MK-3577 PM|Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
10962884|NCT00868790|EG003|Reported Event|MK-3577 BID|Participants received 25 mg MK-3577 orally BID for 4 weeks.
10962885|NCT00868790|EG004|Reported Event|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
10962886|NCT00868959|BG000|Baseline|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
10962887|NCT00868959|FG000|Participant Flow|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
10962888|NCT00868959|OG000|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
10962889|NCT00868959|EG000|Reported Event|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
11376795|NCT02575976|FG001|Participant Flow|Exercise-based CR|"Exercise-based cardiac rehabilitation~exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions."
11376796|NCT02575976|FG002|Participant Flow|Wait List Control|"no cardiac rehabilitation~wait list control: No cardiac rehabilitation."
11376797|NCT02575976|OG000|Outcome|Comprehensive CR|"education and exercise-based cardiac rehabilitation~comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)"
11376798|NCT02575976|OG001|Outcome|Exercise-based CR|"Exercise-based cardiac rehabilitation~exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions."
11376799|NCT02575976|OG002|Outcome|Wait List Control|"no cardiac rehabilitation~wait list control: No cardiac rehabilitation."
11373901|NCT04540952|BG000|Baseline|Total Capture Drape|"Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure~Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure."
11373902|NCT04540952|BG001|Baseline|Control|"Standard surgical drape used to adequately collect fluid during hysteroscopy procedure~Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure."
11373903|NCT04540952|BG002|Baseline|Total|Total of all reporting groups
11373904|NCT04540952|FG000|Participant Flow|Total Capture Drape|"Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure~Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure"
11373905|NCT04540952|FG001|Participant Flow|Control|"Standard surgical drape used to adequately collect fluid during hysteroscopy procedure~Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure"
11373906|NCT04540952|OG000|Outcome|Control Group|Control group which used the standard surgical drape used to adequately collect fluid during hysteroscopy procedure
11373907|NCT04540952|OG001|Outcome|Total Capture Drape Group|TCD group which used the surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
11373908|NCT04540952|OG000|Outcome|Total Capture Drape|"Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure~Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure"
11373909|NCT04540952|OG001|Outcome|Control|"Standard surgical drape used to adequately collect fluid during hysteroscopy procedure~Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure"
11190692|NCT02128074|FG000|Participant Flow|KRX-0502|"KRX-0502 (ferric citrate)~KRX-0502: 1g tablets of KRX-0502"
11373910|NCT04540952|EG000|Reported Event|Total Capture Drape|"Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure~Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure."
11373911|NCT04540952|EG001|Reported Event|Control|"Standard surgical drape used to adequately collect fluid during hysteroscopy procedure~Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure."
11373912|NCT04369742|BG000|Baseline|Hydroxychloroquine|Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
11373913|NCT04369742|BG001|Baseline|Placebo|Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
11373914|NCT04369742|BG002|Baseline|Total|Total of all reporting groups
11373915|NCT04369742|FG000|Participant Flow|Hydroxychloroquine|Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
11373916|NCT04369742|FG001|Participant Flow|Placebo|Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
11373917|NCT04369742|OG000|Outcome|Hydroxychloroquine|Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
11373918|NCT04369742|OG001|Outcome|Placebo|Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
11373919|NCT04369742|EG000|Reported Event|Hydroxychloroquine|Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
11373920|NCT04369742|EG001|Reported Event|Placebo|Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
11373921|NCT04346628|BG000|Baseline|Placebo|In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.
11373922|NCT04346628|BG001|Baseline|Favipiravir|In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
11373923|NCT04346628|BG002|Baseline|Total|Total of all reporting groups
11190693|NCT02128074|OG000|Outcome|KRX-0502|"KRX-0502 (ferric citrate)~KRX-0502: 1g tablets of KRX-0502"
11190694|NCT02128074|EG000|Reported Event|KRX-0502|"KRX-0502 (ferric citrate)~KRX-0502: 1g tablets of KRX-0502"
11373924|NCT04346628|FG000|Participant Flow|Placebo|In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.
11373925|NCT04346628|FG001|Participant Flow|Favipiravir|In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
11373926|NCT04346628|OG000|Outcome|Placebo|In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.
11373927|NCT04346628|OG001|Outcome|Favipiravir|In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
11373928|NCT04346628|EG000|Reported Event|Placebo|In addition to standard of care (SOC) treatment for COVID-19 infection, participants were randomized to receive placebo to match favipiravir for 10 days, and to be evaluated for health outcomes through day 28.
11373929|NCT04346628|EG001|Reported Event|Favipiravir|In addition to SOC treatment for COVID-19 infection, participants were randomized to receive favipiravir for 10 days, and to be evaluated for health outcomes through day 28. Favipiravir was administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
10962890|NCT00869024|BG000|Baseline|Stem Cell Therapy|"Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
11373930|NCT04115644|BG000|Baseline|Group 1 (Control)|"will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373931|NCT04115644|BG001|Baseline|Group 2 (Ketorolac)|"will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Ketorolac: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373932|NCT04115644|BG002|Baseline|Group 3 (Kenalog)|"Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Kenalog: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone."
11373933|NCT04115644|BG003|Baseline|Total|Total of all reporting groups
11373934|NCT04115644|FG000|Participant Flow|Group 1 (Control)|"will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373935|NCT04115644|FG001|Participant Flow|Group 2 (Ketorolac)|"will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Ketorolac: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373936|NCT04115644|FG002|Participant Flow|Group 3 (Kenalog)|"Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Kenalog: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone."
11373937|NCT04115644|OG000|Outcome|Group 1 (Control)|"will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373938|NCT04115644|OG001|Outcome|Group 2 (Ketorolac)|"will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Ketorolac: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373939|NCT04115644|OG002|Outcome|Group 3 (Kenalog)|"Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Kenalog: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone."
11373940|NCT04115644|EG000|Reported Event|Group 1 (Control)|"will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373941|NCT04115644|EG001|Reported Event|Group 2 (Ketorolac)|"will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Ketorolac: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine"
11373942|NCT04115644|EG002|Reported Event|Group 3 (Kenalog)|"Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care~Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine~Kenalog: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone."
11373943|NCT04005859|BG000|Baseline|CONTROL: IV Lido|"CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)~IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35~100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.~1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.~Adhesive tapes will be applied at the presumed level of TAP block puncture sites."
11373944|NCT04005859|BG001|Baseline|EXPERIMENTAL: Exparel|"EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)~Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35~Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.~A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.~The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.~Adhesive tapes will be applied at the level of the TAP block puncture sites."
11373945|NCT04005859|BG002|Baseline|Total|Total of all reporting groups
11373946|NCT04005859|FG000|Participant Flow|CONTROL: IV Lido|"CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)~IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35~100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.~1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.~Adhesive tapes will be applied at the presumed level of TAP block puncture sites."
11376800|NCT02575976|EG000|Reported Event|Comprehensive CR|"education and exercise-based cardiac rehabilitation~comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)"
11376801|NCT02575976|EG001|Reported Event|Exercise-based CR|"Exercise-based cardiac rehabilitation~exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions."
11373947|NCT04005859|FG001|Participant Flow|EXPERIMENTAL: Exparel|"EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)~Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35~Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.~A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.~The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.~Adhesive tapes will be applied at the level of the TAP block puncture sites."
11373948|NCT04005859|OG000|Outcome|CONTROL: IV Lido|"CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)~IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35~100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.~1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.~Adhesive tapes will be applied at the presumed level of TAP block puncture sites."
11373949|NCT04005859|OG001|Outcome|EXPERIMENTAL: Exparel|"EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)~Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35~Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.~A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.~The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.~Adhesive tapes will be applied at the level of the TAP block puncture sites."
11373950|NCT04005859|EG000|Reported Event|CONTROL: IV Lido|"CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)~IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35~100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.~1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.~Adhesive tapes will be applied at the presumed level of TAP block puncture sites."
11373951|NCT04005859|EG001|Reported Event|EXPERIMENTAL: Exparel|"EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)~Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35~Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.~A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.~The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.~Adhesive tapes will be applied at the level of the TAP block puncture sites."
11373952|NCT03969589|BG000|Baseline|Reproductive Life Planning-Mental Health Intervention|Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
11373953|NCT03969589|BG001|Baseline|Written Materials on Reproductive Life Planning|Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
11373954|NCT03969589|BG002|Baseline|Total|Total of all reporting groups
11373955|NCT03969589|FG000|Participant Flow|Reproductive Life Planning-Mental Health Intervention|Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
11373956|NCT03969589|FG001|Participant Flow|Written Materials on Reproductive Life Planning|Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
11373957|NCT03969589|OG000|Outcome|Reproductive Life Planning-Mental Health Intervention|Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
11373958|NCT03969589|OG001|Outcome|Written Materials on Reproductive Life Planning|Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
11373959|NCT03969589|EG000|Reported Event|Reproductive Life Planning-Mental Health Intervention|Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
11376802|NCT02575976|EG002|Reported Event|Wait List Control|"no cardiac rehabilitation~wait list control: No cardiac rehabilitation."
10962891|NCT00869024|BG001|Baseline|Placebo|"Intramyocardial Delivery Placebo solution into Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
10962892|NCT00869024|BG002|Baseline|Total|Total of all reporting groups
11373960|NCT03969589|EG001|Reported Event|Written Materials on Reproductive Life Planning|Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
11373961|NCT03875664|BG000|Baseline|Intervention|"Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique~Liposomal bupivacaine: Extended-release local anesthetic"
11373962|NCT03875664|BG001|Baseline|Placebo|"Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique~Placebo - injection: Injectable normal saline solution"
11373963|NCT03875664|BG002|Baseline|Total|Total of all reporting groups
11373964|NCT03875664|FG000|Participant Flow|Intervention|"Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique~Liposomal bupivacaine: Extended-release local anesthetic"
11373965|NCT03875664|FG001|Participant Flow|Placebo|"Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique~Placebo - injection: Injectable normal saline solution"
11373966|NCT03875664|OG000|Outcome|Intervention|"Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique~Liposomal bupivacaine: Extended-release local anesthetic"
11373967|NCT03875664|OG001|Outcome|Placebo|"Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique~Placebo - injection: Injectable normal saline solution"
11373968|NCT03875664|EG000|Reported Event|Intervention|"Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique~Liposomal bupivacaine: Extended-release local anesthetic"
11373969|NCT03875664|EG001|Reported Event|Placebo|"Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique~Placebo - injection: Injectable normal saline solution"
11376803|NCT02545868|BG000|Baseline|Group A1|Participants received dual infusion of ocrelizumab (OCR) 300 milligrams (mg) on Day 1 and then on Day 15, and then participants further received immunization course: tetanus toxoid (TT) containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine (23-PPV) boosted with 13-valent pneumococcal conjugate vaccine (13-PCV), and repeated administration with keyhole limpet hemocyanin (KLH) at 12 weeks post-OCR treatment until Week 24.
11376804|NCT02545868|BG001|Baseline|Group A2|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376805|NCT02545868|BG002|Baseline|Group B|Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization study period. Participants who completed the 12-week immunization study period had the option to receive two single infusions of OCR 300 mg, on Day 84 and Day 98, and subsequent single infusions (600 mg OCR) at intervals of 24 weeks.
11376806|NCT02545868|BG003|Baseline|Total|Total of all reporting groups
11376807|NCT02545868|FG000|Participant Flow|Group A1|Participants received dual infusion of ocrelizumab (OCR) 300 milligrams (mg) on Day 1 and then on Day 15, and then participants further received immunization course: tetanus toxoid (TT) containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine (23-PPV) boosted with 13-valent pneumococcal conjugate vaccine (13-PCV), and repeated administration with keyhole limpet hemocyanin (KLH) at 12 weeks post-OCR treatment until Week 24. Participants who completed the 24-week immunization study period had the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks.
11376808|NCT02545868|FG001|Participant Flow|Group A2|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24. Participants who completed the 24-week immunization study period had the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks.
11376809|NCT02545868|FG002|Participant Flow|Group B|Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization study period. Participants who completed the 12-week immunization study period had the option to receive two single infusions of OCR 300 mg, on Day 84 and Day 98, and subsequent single infusions (600 mg OCR) at intervals of 24 weeks.
11376810|NCT02545868|OG000|Outcome|Group A (A1 + A2)|Participants received dual infusion of ocrelizumab (OCR) 300 milligrams (mg) on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: tetanus toxoid (TT) containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine (23-PPV) and repeated administration with keyhole limpet hemocyanin (KLH). In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
11376811|NCT02545868|OG001|Outcome|Group B|Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization study period.
11376812|NCT02545868|OG000|Outcome|Group A (A1 + A2)|Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
11376813|NCT02545868|OG000|Outcome|Group A1|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376814|NCT02545868|OG001|Outcome|Group A2|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11373970|NCT03812588|BG000|Baseline|Clinical Frequency Management: Placebo|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373971|NCT03812588|BG001|Baseline|Research Frequency Management: Placebo|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373972|NCT03812588|BG002|Baseline|Clinical Frequency Management: Escitalopram|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373973|NCT03812588|BG003|Baseline|Research Frequency Management: Escitalopram|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373974|NCT03812588|BG004|Baseline|Total|Total of all reporting groups
11373975|NCT03812588|FG000|Participant Flow|Clinical Frequency Management: Placebo|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373976|NCT03812588|FG001|Participant Flow|Research Frequency Management: Placebo|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373977|NCT03812588|FG002|Participant Flow|Clinical Frequency Management: Escitalopram|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373978|NCT03812588|FG003|Participant Flow|Research Frequency Management: Escitalopram|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373979|NCT03812588|OG000|Outcome|Clinical Frequency Management: Placebo|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373980|NCT03812588|OG001|Outcome|Research Frequency Management: Placebo|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373981|NCT03812588|OG002|Outcome|Clinical Frequency Management: Escitalopram|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373982|NCT03812588|OG003|Outcome|Research Frequency Management: Escitalopram|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373983|NCT03812588|EG000|Reported Event|Clinical Frequency Management: Placebo|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11376815|NCT02545868|OG002|Outcome|Group B|Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization study period.
10962893|NCT00869024|FG000|Participant Flow|Stem Cell Therapy|"Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
11373984|NCT03812588|EG001|Reported Event|Research Frequency Management: Placebo|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient."
11373985|NCT03812588|EG002|Reported Event|Clinical Frequency Management: Escitalopram|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373986|NCT03812588|EG003|Reported Event|Research Frequency Management: Escitalopram|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.~Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain."
11373987|NCT03690674|BG000|Baseline|Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373988|NCT03690674|FG000|Participant Flow|Caregivers - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373989|NCT03690674|FG001|Participant Flow|Children - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373990|NCT03690674|OG000|Outcome|Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373991|NCT03690674|OG000|Outcome|Caregivers - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373992|NCT03690674|OG001|Outcome|Children - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373993|NCT03690674|EG000|Reported Event|Caregivers - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373994|NCT03690674|EG001|Reported Event|Children - Lifestyle Enhancement for ADHD Program|"There is no comparison/control arm.~Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting."
11373995|NCT03655691|BG000|Baseline|Vehicle|"Vehicle / Placebo formulation~Vehicle: Vehicle Formulation, administered once, topically, at Baseline"
11373996|NCT03655691|BG001|Baseline|Dose 1|"lower dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline"
11373997|NCT03655691|BG002|Baseline|Dose 2|"higher dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, Dose 2, administered once, topically, at Baseline"
11373998|NCT03655691|BG003|Baseline|Total|Total of all reporting groups
11373999|NCT03655691|FG000|Participant Flow|Vehicle|"Vehicle / Placebo formulation~Vehicle: Vehicle Formulation, administered once, topically, at Baseline"
11374000|NCT03655691|FG001|Participant Flow|Dose 1|"lower dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline"
11374001|NCT03655691|FG002|Participant Flow|Dose 2|"higher dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline"
11374002|NCT03655691|OG000|Outcome|Vehicle|"Vehicle / Placebo formulation~Vehicle: Vehicle Formulation, administered once, topically, at Baseline"
11374003|NCT03655691|OG001|Outcome|Dose 1|"lower dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline"
11374004|NCT03655691|OG002|Outcome|Dose 2|"higher dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline"
11374005|NCT03655691|EG000|Reported Event|Vehicle|"Vehicle / Placebo formulation~Vehicle: Vehicle Formulation"
11374006|NCT03655691|EG001|Reported Event|Dose 1|"lower dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, Dose 1"
10962894|NCT00869024|FG001|Participant Flow|Placebo|"Intramyocardial Delivery Placebo solution into Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
11374007|NCT03655691|EG002|Reported Event|Dose 2|"higher dose of ET-01~botulinum toxin, Type A: botulinum toxin, Type A, Dose 2"
10962895|NCT00869024|OG000|Outcome|Stem Cell Therapy|"Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
10962896|NCT00869024|OG001|Outcome|Placebo|"Intramyocardial Delivery Placebo solution into Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
10962897|NCT00869024|EG000|Reported Event|Stem Cell Therapy|"Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
11374008|NCT03608670|BG000|Baseline|Experimental|"Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.~Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing."
11374009|NCT03608670|FG000|Participant Flow|Experimental|"Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.~Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing."
11374010|NCT03608670|OG000|Outcome|Experimental|"Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.~Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing."
11374011|NCT03608670|EG000|Reported Event|Experimental|"Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.~Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing."
11376816|NCT02545868|OG000|Outcome|Group A1|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376817|NCT02545868|OG000|Outcome|Group A2|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376818|NCT02545868|EG000|Reported Event|Group A1|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376819|NCT02545868|EG001|Reported Event|Group A2|Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
11376820|NCT02545868|EG002|Reported Event|Group B|Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
11376821|NCT02470091|BG000|Baseline|Cohort 1: Measurable|Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
11376822|NCT02470091|BG001|Baseline|Cohort 2: Resection|Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
11376823|NCT02470091|BG002|Baseline|Total|Total of all reporting groups
11376824|NCT02470091|FG000|Participant Flow|Cohort 1: Measurable|Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
11376825|NCT02470091|FG001|Participant Flow|Cohort 2: Resection|Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
11376826|NCT02470091|OG000|Outcome|Cohort 1: Measurable|Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
11376827|NCT02470091|OG000|Outcome|Cohort 2: Resection|Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
11376828|NCT02470091|OG001|Outcome|Cohort 2: Resection|Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
11376829|NCT02470091|OG000|Outcome|Treatment (Denosumab)|Patients receive denosumab SC on day 1 (days 1, 8, and 15 of course 1 only). Treatment repeats every 4 weeks (28 days) for up to 24 months or 26 courses, whichever occurs first, in the absence of disease progression or unacceptable toxicity.
11376830|NCT02470091|EG000|Reported Event|Cohort 1: Measurable|Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
11376831|NCT02470091|EG001|Reported Event|Cohort 2: Resection|Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
11376832|NCT02440425|BG000|Baseline|Combination Therapy|"Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.~Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.~Paclitaxel: Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1."
11376833|NCT02440425|FG000|Participant Flow|Combination Therapy|"Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.~Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.~Paclitaxel: Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1."
10962898|NCT00869024|EG001|Reported Event|Placebo|"Intramyocardial Delivery Placebo solution into Patients with Severe LV Dysfunction and LVAD Support~Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells: Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit)."
11341649|NCT03686033|FG003|Participant Flow|Sequence 4: Placebo + E2082 25 mg + E2082 2.5 mg + E2082 40 mg|Participants received, E2082-matched placebo (Treatment A) tablet, orally, once on Day 1 in Treatment Period 1, followed by E2082 25 mg (Treatment C) tablet, orally, once on Day 1 in Treatment Period 2, followed by E2082 2.5 mg (Treatment B) tablet, orally, once on Day 1 in Treatment Period 3, followed by E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 4 (Open-label). A washout phase of at least 2 weeks was maintained between the treatment periods.
11374012|NCT03364686|BG000|Baseline|Biotin-Labeled Red Blood Cells Infusion|"Each participant will receive 2 transfusions of biotin labeled red blood cells.~Biotin-Labeled Red Blood Cells: We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage)."
11374013|NCT03364686|FG000|Participant Flow|Biotin-Labeled Red Blood Cells Infusion|"Each participant will receive 2 transfusions of biotin labeled red blood cells.~Biotin-Labeled Red Blood Cells: We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage)."
11374014|NCT03364686|OG000|Outcome|Biotin-Labeled Red Blood Cells Infusion|"Each participant will receive 2 transfusions of biotin labeled red blood cells.~Biotin-Labeled Red Blood Cells: We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage)."
11374015|NCT03364686|EG000|Reported Event|Biotin-Labeled Red Blood Cells Infusion|"Each participant will receive 2 transfusions of biotin labeled red blood cells.~Biotin-Labeled Red Blood Cells: We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage)."
11374016|NCT03345771|BG000|Baseline|Antimicrobial Barrier Dressing|"postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7~Antimicrobial Barrier Dressing: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver."
11374017|NCT03345771|BG001|Baseline|Closed-incision Negative Pressure Therapy|"portable NPWT device placed in the operating room from surgery to postoperative day 7~Negative Pressure Wound Therapy (NPWT): PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing"
11374018|NCT03345771|BG002|Baseline|Total|Total of all reporting groups
11374019|NCT03345771|FG000|Participant Flow|Antimicrobial Barrier Dressing|"postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7~Antimicrobial Barrier Dressing: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver."
11374020|NCT03345771|FG001|Participant Flow|Closed-incision Negative Pressure Therapy|"portable NPWT device placed in the operating room from surgery to postoperative day 7~Negative Pressure Wound Therapy (NPWT): PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing"
11374021|NCT03345771|OG000|Outcome|Antimicrobial Barrier Dressing|"postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7~Antimicrobial Barrier Dressing: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver."
11374022|NCT03345771|OG001|Outcome|Closed-incision Negative Pressure Therapy|"portable NPWT device placed in the operating room from surgery to postoperative day 7~Negative Pressure Wound Therapy (NPWT): PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing"
11374023|NCT03345771|EG000|Reported Event|Antimicrobial Barrier Dressing|"postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7~Antimicrobial Barrier Dressing: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver."
11374024|NCT03345771|EG001|Reported Event|Closed-incision Negative Pressure Therapy|"portable NPWT device placed in the operating room from surgery to postoperative day 7~Negative Pressure Wound Therapy (NPWT): PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing"
11374025|NCT03326856|BG000|Baseline|Vehicle|"Vehicle~Vehicle: Vehicle Formulation"
11374026|NCT03326856|BG001|Baseline|Dose 1|botulinum toxin, Type A, topical liniment Dose 1x on Day 0
11374027|NCT03326856|BG002|Baseline|Dose 2|botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0
11374028|NCT03326856|BG003|Baseline|Dose 3|botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0
11374029|NCT03326856|BG004|Baseline|Dose 4|botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
11374030|NCT03326856|BG005|Baseline|Total|Total of all reporting groups
11374031|NCT03326856|FG000|Participant Flow|Vehicle|"Vehicle~Vehicle: Vehicle Formulation"
11374032|NCT03326856|FG001|Participant Flow|Dose 1|botulinum toxin, Type A, topical liniment Dose 1x on Day 0
11374033|NCT03326856|FG002|Participant Flow|Dose 2|botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0
11374034|NCT03326856|FG003|Participant Flow|Dose 3|botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0
11374035|NCT03326856|FG004|Participant Flow|Dose 4|botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
11374036|NCT03326856|OG000|Outcome|Vehicle|"Vehicle~Vehicle: Vehicle Formulation"
11374037|NCT03326856|OG001|Outcome|Dose 1|botulinum toxin, Type A, topical liniment Dose 1x on Day 0
11374038|NCT03326856|OG002|Outcome|Dose 2|botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0
11374039|NCT03326856|OG003|Outcome|Dose 3|botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0
11190695|NCT02128217|BG000|Baseline|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin(RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
10850245|NCT00300781|FG001|Participant Flow|Neratinib 240, No Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with with no prior trastuzumab treatment.
11374040|NCT03326856|OG004|Outcome|Dose 4|botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
11374041|NCT03326856|EG000|Reported Event|Vehicle|"Vehicle~Vehicle: Vehicle Formulation"
11374042|NCT03326856|EG001|Reported Event|Dose 1|botulinum toxin, Type A, topical liniment Dose 1x on Day 0
11374043|NCT03326856|EG002|Reported Event|Dose 2|botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0
11374044|NCT03326856|EG003|Reported Event|Dose 3|botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0
11374045|NCT03326856|EG004|Reported Event|Dose 4|botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
11374046|NCT03287947|BG000|Baseline|Nintedanib|Subjects received 200 mg oral nintedanib, taken twice daily.
11374047|NCT03287947|FG000|Participant Flow|Nintedanib|Participants received 200 mg oral nintedanib, taken twice daily.
11374048|NCT03287947|OG000|Outcome|Nintedanib|Subjects received 200 mg oral nintedanib, taken twice daily.
10850246|NCT00300781|OG000|Outcome|Neratinib 240, Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
10850247|NCT00300781|OG001|Outcome|Neratinib 240, No Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
11374049|NCT03287947|EG000|Reported Event|Nintedanib|Subjects received 200 mg oral nintedanib, taken twice daily.
11374050|NCT03287089|BG000|Baseline|Nitrofurantoin|"Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal~Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days"
11374051|NCT03287089|BG001|Baseline|Placebo|"Receives twice daily matching placebo for 5 days following catheter removal~Placebo Oral Tablet: Matching placebo"
11374052|NCT03287089|BG002|Baseline|Total|Total of all reporting groups
11374053|NCT03287089|FG000|Participant Flow|Nitrofurantoin|"Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal~Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days"
11374054|NCT03287089|FG001|Participant Flow|Placebo|"Receives twice daily matching placebo for 5 days following catheter removal~Placebo Oral Tablet: Matching placebo"
11374055|NCT03287089|OG000|Outcome|Nitrofurantoin|"Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal~Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days"
11374056|NCT03287089|OG001|Outcome|Placebo|"Receives twice daily matching placebo for 5 days following catheter removal~Placebo Oral Tablet: Matching placebo"
11374057|NCT03287089|EG000|Reported Event|Nitrofurantoin|"Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal~Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days"
11374058|NCT03287089|EG001|Reported Event|Placebo|"Receives twice daily matching placebo for 5 days following catheter removal~Placebo Oral Tablet: Matching placebo"
11374059|NCT03240692|BG000|Baseline|Accelerated Theta Burst Treatment|"All participants will receive theta-burst TMS.~Accelerated theta-burst stimulation treatment: All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system."
11374060|NCT03240692|FG000|Participant Flow|Accelerated Theta Burst Treatment|"All participants will receive theta-burst TMS.~Accelerated theta-burst stimulation treatment: All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system."
11374061|NCT03240692|OG000|Outcome|Accelerated Theta Burst Treatment|"All participants will receive theta-burst TMS.~Accelerated theta-burst stimulation treatment: All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system."
11374062|NCT03240692|EG000|Reported Event|Accelerated Theta Burst Treatment|"All participants will receive theta-burst TMS.~Accelerated theta-burst stimulation treatment: All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system."
11374063|NCT03227029|BG000|Baseline|RSV ΔNS2/Δ1313/I1314L Vaccine|"Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).~RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops"
11374064|NCT03227029|BG001|Baseline|RSV 276 Vaccine|"Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).~RSV 276: 10^5 PFU; administered as nose drops"
11374065|NCT03227029|BG002|Baseline|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11374066|NCT03227029|BG003|Baseline|Total|Total of all reporting groups
11374067|NCT03227029|FG000|Participant Flow|RSV ΔNS2/Δ1313/I1314L Vaccine|"Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).~RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops"
11374068|NCT03227029|FG001|Participant Flow|RSV 276 Vaccine|"Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).~RSV 276: 10^5 PFU; administered as nose drops"
11374069|NCT03227029|FG002|Participant Flow|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11374070|NCT03227029|OG000|Outcome|RSV ΔNS2/Δ1313/I1314L Vaccine|"Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).~RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops"
11374071|NCT03227029|OG001|Outcome|RSV 276 Vaccine|"Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).~RSV 276: 10^5 PFU; administered as nose drops"
11374072|NCT03227029|OG002|Outcome|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11374073|NCT03227029|EG000|Reported Event|RSV Delta NS2|"Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).~RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops"
11374074|NCT03227029|EG001|Reported Event|RSV 276|"Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).~RSV 276: 10^5 PFU; administered as nose drops"
11374075|NCT03227029|EG002|Reported Event|Placebo|Participants received a single dose of placebo at study entry (Day 0). Placebo: Isotonic diluent, administered as nose drops
11374076|NCT03207776|BG000|Baseline|Control|"Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).~Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site."
11374077|NCT03207776|BG001|Baseline|Intervention|"A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).~COPD Clinical Pathway: A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services."
11374078|NCT03207776|BG002|Baseline|Total|Total of all reporting groups
11374079|NCT03207776|FG000|Participant Flow|Control|"Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).~Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site."
11190696|NCT02128217|BG001|Baseline|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
11190697|NCT02128217|BG002|Baseline|Total|Total of all reporting groups
11190698|NCT02128217|FG000|Participant Flow|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
11374080|NCT03207776|FG001|Participant Flow|Intervention|"A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).~COPD Clinical Pathway: A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services."
11374081|NCT03207776|OG000|Outcome|Control|"Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).~Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site."
11374082|NCT03207776|OG001|Outcome|Intervention|"A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).~COPD Clinical Pathway: A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services."
11374083|NCT03207776|EG000|Reported Event|Control|"Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).~Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site."
11374084|NCT03207776|EG001|Reported Event|Intervention|"A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).~COPD Clinical Pathway: A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services."
11374085|NCT03204643|BG000|Baseline|BH-VPN|"A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.~BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services."
11374086|NCT03204643|BG001|Baseline|Usual Care|The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
11374087|NCT03204643|BG002|Baseline|Total|Total of all reporting groups
11374088|NCT03204643|FG000|Participant Flow|BH-VPN|"A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.~BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services."
11374089|NCT03204643|FG001|Participant Flow|Usual Care|The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
11374090|NCT03204643|OG000|Outcome|BH-VPN|"A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.~BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services."
11374091|NCT03204643|OG001|Outcome|Usual Care|The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
11374092|NCT03204643|EG000|Reported Event|BH-VPN|"A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.~BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services."
11374093|NCT03204643|EG001|Reported Event|Usual Care|The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
11374094|NCT03182829|BG000|Baseline|Factor Xa Inhibitor|Patients on therapy with apixaban, edoxaban and rivaroxaban for at least 7 days
11374095|NCT03182829|BG001|Baseline|Thrombin Inhibitor|Patients on therapy with dabigatran for at least 7 days
11374096|NCT03182829|BG002|Baseline|Total|Total of all reporting groups
11374097|NCT03182829|FG000|Participant Flow|Factor Xa Inhibitor|The aim was to include 450 patients on stable treatment with apixaban, edoxaban and rivaroxaban
11374098|NCT03182829|FG001|Participant Flow|Thrombin Inhibitor|The aim was to include 450 patients on stable treatment with dabigatran
11374099|NCT03182829|OG000|Outcome|Factor Xa Inhibitor|Patients on treatment with apixaban, edoxaban, rivaroxaban
11374100|NCT03182829|OG001|Outcome|Thrombin Inhibitor|Patients treated with dabigatran
11374101|NCT03182829|EG000|Reported Event|Factor Xa Inhibitor|Patients on treatment with apxiban, edoxaban and rivaroxaban
11374102|NCT03182829|EG001|Reported Event|Thrombin Inhibitor|Patients on treatment with dabigatran
11374103|NCT03181789|BG000|Baseline|Group 1: Vaccine|P24CE1/2(CE/CE) + gag vaccines
11374104|NCT03181789|BG001|Baseline|Group 2: Vaccine|P55gag (gag/gag) vaccines
11374105|NCT03181789|BG002|Baseline|Group 3: Control 1|Placebo: Sodium Chloride, USP 0.9%
11374106|NCT03181789|BG003|Baseline|Group 4: Control 2|Placebo: Sodium Chloride, USP 0.9%
11374107|NCT03181789|BG004|Baseline|Total|Total of all reporting groups
11374108|NCT03181789|FG000|Participant Flow|Group 1: Vaccine|P24CE1/2(CE/CE) + gag vaccines
11374109|NCT03181789|FG001|Participant Flow|Group 2: Vaccine|P55gag (gag/gag) vaccines
11374110|NCT03181789|FG002|Participant Flow|Group 3: Control 1|Placebo: Sodium Chloride, USP 0.9%
11374111|NCT03181789|FG003|Participant Flow|Group 4: Control 2|Placebo: Sodium Chloride, USP 0.9%
11374112|NCT03181789|OG000|Outcome|Group 1: Vaccine|P24CE1/2(CE/CE) + gag vaccines
11374113|NCT03181789|OG001|Outcome|Group 2: Vaccine|P55gag (gag/gag) vaccines
11374114|NCT03181789|OG002|Outcome|Group 3: Control 1|Placebo: Sodium Chloride, USP 0.9%
11374115|NCT03181789|OG003|Outcome|Group 4: Control 2|Placebo: Sodium Chloride, USP 0.9%
11374116|NCT03181789|EG000|Reported Event|Group 1: Vaccine|P24CE1/2(CE/CE) + gag vaccines
11374117|NCT03181789|EG001|Reported Event|Group 2: Vaccine|P55gag (gag/gag) vaccines
11374118|NCT03181789|EG002|Reported Event|Group 3: Control 1|Placebo: Sodium Chloride, USP 0.9%
11374119|NCT03181789|EG003|Reported Event|Group 4: Control 2|Placebo: Sodium Chloride, USP 0.9%
11374120|NCT03164356|BG000|Baseline|Arm 1 - Pre and Post Modification Observation, No Intervention|In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
11374121|NCT03164356|BG001|Baseline|Arm 2 - Treatment Group, Pre and Post Modification|Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
11374122|NCT03164356|BG002|Baseline|Arm 2 - Control Group, Pre and Post Modification|Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
11374123|NCT03164356|BG003|Baseline|Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374124|NCT03164356|BG004|Baseline|Arm 2 - Control Group Prosthetists, Pre and Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374125|NCT03164356|BG005|Baseline|Total|Total of all reporting groups
11374126|NCT03164356|FG000|Participant Flow|Arm 1 - Pre and Post Modification Observation, No Intervention|In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
11374127|NCT03164356|FG001|Participant Flow|Arm 2 - Treatment Group, Pre and Post Modification|Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
11374128|NCT03164356|FG002|Participant Flow|Arm 2 - Control Group, Pre and Post Modification|Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
11374129|NCT03164356|FG003|Participant Flow|Arm 2 - Prosthetists, Pre and Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374130|NCT03164356|OG000|Outcome|Arm 1|In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
11374131|NCT03164356|OG001|Outcome|Arm 2 - Treatment|"Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.~Bioimpedance monitor: Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort."
11374132|NCT03164356|OG002|Outcome|Arm 3 - Control|Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
11374133|NCT03164356|OG000|Outcome|Arm 1 - Pre and Post Modification Observation, No Intervention|In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
11374134|NCT03164356|OG001|Outcome|Arm 2 - Treatment Group, Pre and Post Modification|Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
11374135|NCT03164356|OG002|Outcome|Arm 2 - Control Group, Pre and Post Modification|Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
11374136|NCT03164356|OG000|Outcome|Arm 2 - Treatment Group Prosthetists, Pre Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374137|NCT03164356|OG001|Outcome|Arm 2 - Control Group Prosthetists, Pre-Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374138|NCT03164356|OG000|Outcome|Arm 2 - Treatment Group, Pre and Post Modification|Participants' socket modifications were based only on their prosthetists. Prosthetists for this group did not receive any bioimpedance data to inform their decisions.
11374139|NCT03164356|OG001|Outcome|Arm 2 - Control Group, Pre and Post Modification|Participants' socket modifications were based on their prosthetists after said prosthetists received bioimpedance data.
11190699|NCT02128217|FG001|Participant Flow|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
11374140|NCT03164356|OG000|Outcome|Arm 2 - Treatment Group Prosthetists, Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374141|NCT03164356|OG001|Outcome|Arm 2 - Control Group Prosthetists, Post-Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374142|NCT03164356|OG001|Outcome|Arm 2 - Control Group Prosthetists, Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374143|NCT03164356|EG000|Reported Event|Arm 1 - Pre and Post Modification Observation, No Intervention|In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
11374144|NCT03164356|EG001|Reported Event|Arm 2 - Treatment Group, Pre and Post Modification|Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
11374145|NCT03164356|EG002|Reported Event|Arm 2 - Control Group, Pre and Post Modification|Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
11374146|NCT03164356|EG003|Reported Event|Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374147|NCT03164356|EG004|Reported Event|Arm 2 - Control Group Prosthetists, Pre and Post Modifications|Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.
11374148|NCT02975700|BG000|Baseline|PLX3397|Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening).
11374149|NCT02975700|FG000|Participant Flow|PLX3397|Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening).
11374150|NCT02975700|OG000|Outcome|PLX3397|Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening).
11374151|NCT02975700|EG000|Reported Event|PLX3397|Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening).
11374152|NCT02941549|BG000|Baseline|Placebo|2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374153|NCT02941549|BG001|Baseline|1000 mg Epeleuton|1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
11374154|NCT02941549|BG002|Baseline|2000 mg Epeleuton|2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374155|NCT02941549|BG003|Baseline|Total|Total of all reporting groups
11374156|NCT02941549|FG000|Participant Flow|Placebo|2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374157|NCT02941549|FG001|Participant Flow|1000 mg Epeleuton|1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
11374158|NCT02941549|FG002|Participant Flow|2000mg Epeleuton|2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374159|NCT02941549|OG000|Outcome|Placebo|2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
11374160|NCT02941549|OG001|Outcome|1000 mg Epeleuton|1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.
11374161|NCT02941549|OG002|Outcome|2000 mg Epeleuton|2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
11374162|NCT02941549|OG002|Outcome|2000 mg Epeleuton|2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374163|NCT02941549|OG000|Outcome|Placebo|2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374164|NCT02941549|OG001|Outcome|1000 mg Epeleuton|1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
11374165|NCT02941549|EG000|Reported Event|Placebo|2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374166|NCT02941549|EG001|Reported Event|1000 mg Epeleuton|1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
11374167|NCT02941549|EG002|Reported Event|2000 mg Epeleuton|2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
11374168|NCT02937766|BG000|Baseline|Treatment A|"Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374169|NCT02937766|BG001|Baseline|Treatment B|"Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374170|NCT02937766|BG002|Baseline|Total|Total of all reporting groups
11190700|NCT02128217|OG000|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
11190701|NCT02128217|OG001|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
11374171|NCT02937766|FG000|Participant Flow|Treatment A|"Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374172|NCT02937766|FG001|Participant Flow|Treatment B|"Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374173|NCT02937766|OG000|Outcome|Treatment A|"Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374174|NCT02937766|OG001|Outcome|Treatment B|"Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374175|NCT02937766|EG000|Reported Event|Treatment A|"Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374176|NCT02937766|EG001|Reported Event|Treatment B|"Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)~Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)"
11374177|NCT02927938|BG000|Baseline|Evaluable Cohort - Transplant Arm|"Standard of Care Consolidation (HCT)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT~Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy"
11374178|NCT02927938|BG001|Baseline|Evaluable Cohort - Consolidation Chemo Arm|"Standard of Care Consolidation (cytarabine-based chemo)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT)~Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy"
11374179|NCT02927938|BG002|Baseline|Observational Cohort 1|Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.
11374180|NCT02927938|BG003|Baseline|Observational Cohort 2|"Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria:~Lack the immunophenotype of interest,~Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT)~HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT~Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy.~HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT."
11374181|NCT02927938|BG004|Baseline|Total|Total of all reporting groups
11374182|NCT02927938|FG000|Participant Flow|Evaluable Cohort - Transplant Arm|"Standard of Care Consolidation (HCT)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT~Allogeneic HCT"
11374183|NCT02927938|FG001|Participant Flow|Evaluable Cohort - Consolidation Chemo Arm|"Standard of Care Consolidation (cytarabine-based chemo)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT)~Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy"
11374184|NCT02927938|FG002|Participant Flow|Observational Cohort 1|Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.
10963955|NCT00875056|OG002|Outcome|Other Disease|Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
10963956|NCT00875056|EG000|Reported Event|Follicular Lymphoma (FL)|Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11374185|NCT02927938|FG003|Participant Flow|Observational Cohort 2|"Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria:~Lack the immunophenotype of interest,~Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT)~HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT~Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy.~HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT."
11374186|NCT02927938|OG000|Outcome|eLSC+ (Evaluable Cohort)|Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells detected post-consolidation. Note, eLSC indicates the time point after consolidation.
11374187|NCT02927938|OG001|Outcome|eLSC- (Evaluable Cohort)|Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells not detected post-consolidation. Note, eLSC indicates the time point after consolidation.
11374188|NCT02927938|EG000|Reported Event|Evaluable Cohort - Transplant Arm|"Standard of Care Consolidation (HCT)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT~Allogeneic HCT: Allogeneic HCT"
11374189|NCT02927938|EG001|Reported Event|Evaluable Cohort - Consolidation Chemo Arm|"Standard of Care Consolidation (cytarabine-based chemo)~Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:~Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)~Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)~Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT)~Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy"
11374190|NCT02927938|EG002|Reported Event|Observational Cohort 1|Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.
11374191|NCT02927938|EG003|Reported Event|Observational Cohort 2|"Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria:~Lack the immunophenotype of interest,~Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT)~HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT~Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy.~HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT."
11374192|NCT02913131|BG000|Baseline|Part A: Feasibility Run-In|Patients with advanced solid tumor malignancies with at least one liver metastasis will be enrolled with iterative adjustment of coil design to optimize imaging parameters including spatial resolution and signal-to-noise ratio (SNR) of hyperpolarized pyruvate / lactate within the target metastatic lesion(s).
11374193|NCT02913131|BG001|Baseline|Part B: Biomarker Cohort|Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic MR imaging who are planning on being treated with agent targeting PI3K/mTOR pathway will be enrolled.
11374194|NCT02913131|BG002|Baseline|Total|Total of all reporting groups
11374195|NCT02913131|FG000|Participant Flow|Part A: Feasibility Run-In|Patients with advanced solid tumor malignancies with at least one liver metastasis will be enrolled with iterative adjustment of coil design to optimize imaging parameters including spatial resolution and signal-to-noise ratio (SNR) of hyperpolarized pyruvate / lactate within the target metastatic lesion(s).
11374196|NCT02913131|FG001|Participant Flow|Part B: Biomarker Cohort|Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic magnetic resonance (MR) imaging who are planning on being treated with agent targeting phosphatidylinositol 3-kinase (PI3K)/Mechanistic target of rapamycin (mTOR) pathway will be enrolled.
11374197|NCT02913131|OG000|Outcome|Part A: Feasibility Run-In|Patients with advanced solid tumor malignancies with at least one liver metastasis will be enrolled with iterative adjustment of coil design to optimize imaging parameters including spatial resolution and signal-to-noise ratio (SNR) of hyperpolarized pyruvate / lactate within the target metastatic lesion(s).
11374198|NCT02913131|OG000|Outcome|Part B: Biomarker Cohort|Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic MR imaging who are planning on being treated with agent targeting PI3K/mTOR pathway will be enrolled.
11374199|NCT02913131|OG001|Outcome|Part B: Biomarker Cohort|Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic MR imaging who are planning on being treated with agent targeting PI3K/mTOR pathway will be enrolled.
11374200|NCT02913131|EG000|Reported Event|Part A: Feasibility Run-In|Patients with advanced solid tumor malignancies with at least one liver metastasis will be enrolled with iterative adjustment of coil design to optimize imaging parameters including spatial resolution and signal-to-noise ratio (SNR) of hyperpolarized pyruvate / lactate within the target metastatic lesion(s).
10963957|NCT00875056|EG001|Reported Event|Indolent Non-FL B-NHL or MCL|Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
11374201|NCT02913131|EG001|Reported Event|Part B: Biomarker Cohort|Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic MR imaging who are planning on being treated with agent targeting PI3K/mTOR pathway will be enrolled.
11374202|NCT02883400|BG000|Baseline|SOC-Standard of Care|standard of care, nontreatment
11374203|NCT02883400|BG001|Baseline|Spironolactone|"spironolactone~Spironolactone: spironolactone 25 mg up to 50 mg"
11374204|NCT02883400|BG002|Baseline|Total|Total of all reporting groups
11374205|NCT02883400|FG000|Participant Flow|SOC-Standard of Care|standard of care, nontreatment
11374206|NCT02883400|FG001|Participant Flow|Spironolactone|"spironolactone~Spironolactone: spironolactone 25 mg up to 50 mg"
11374207|NCT02883400|OG000|Outcome|SOC-Standard of Care|Standard of care
11374208|NCT02883400|OG001|Outcome|Spironolactone|spironolactone group
11374209|NCT02883400|EG000|Reported Event|SOC-Standard of Care|standard of care, nontreatment
11374210|NCT02883400|EG001|Reported Event|Spironolactone|"spironolactone~Spironolactone: spironolactone 25 mg up to 50 mg"
11376834|NCT02440425|OG000|Outcome|Combination Therapy|"Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.~Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.~Paclitaxel: Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1."
11376835|NCT02440425|EG000|Reported Event|Combination Therapy|"Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.~Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.~Paclitaxel: Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1."
11376836|NCT02343120|BG000|Baseline|Part 1: 40 mg QD|Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376837|NCT02343120|BG001|Baseline|Part 1: 80 mg QD|Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376838|NCT02343120|BG002|Baseline|Part 1: 160 mg QD|Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376839|NCT02343120|BG003|Baseline|Part 1 and Part 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376840|NCT02343120|BG004|Baseline|Part 1 and Part 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376841|NCT02343120|BG005|Baseline|Total|Total of all reporting groups
11376842|NCT02343120|FG000|Participant Flow|Part 1: 40 mg QD|Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376843|NCT02343120|FG001|Participant Flow|Part 1: 80 mg QD|Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376844|NCT02343120|FG002|Participant Flow|Part 1: 160 mg QD|Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376845|NCT02343120|FG003|Participant Flow|Part 1 and Part 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376846|NCT02343120|FG004|Participant Flow|Part 1 and Part 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376847|NCT02343120|OG000|Outcome|Part 1: 40 mg QD|Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376848|NCT02343120|OG001|Outcome|Part 1: 80 mg QD|Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376849|NCT02343120|OG002|Outcome|Part 1: 160 mg QD|Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376850|NCT02343120|OG003|Outcome|Parts 1 and 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11374211|NCT02855060|BG000|Baseline|Pelvic Binder|"Commercially available device used to stabilize the pelvis~Pelvic Binder"
11374212|NCT02855060|BG001|Baseline|No Binder|Standard of care
11374213|NCT02855060|BG002|Baseline|Total|Total of all reporting groups
11374214|NCT02855060|FG000|Participant Flow|Pelvic Binder|"Commercially available device used to stabilize the pelvis~Pelvic Binder"
11374215|NCT02855060|FG001|Participant Flow|No Binder|Standard of care
11374216|NCT02855060|OG000|Outcome|Pelvic Binder|"Commercially available device used to stabilize the pelvis~Pelvic Binder"
11374217|NCT02855060|OG001|Outcome|No Binder|Standard of care
11374218|NCT02855060|EG000|Reported Event|Pelvic Binder|"Commercially available device used to stabilize the pelvis~Pelvic Binder"
11374219|NCT02855060|EG001|Reported Event|No Binder|Standard of care
11374220|NCT02823574|BG000|Baseline|Treatment A - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374221|NCT02823574|BG001|Baseline|Treatment B - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374222|NCT02823574|BG002|Baseline|Treatment A - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374223|NCT02823574|BG003|Baseline|Treatment B - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374224|NCT02823574|BG004|Baseline|Total|Total of all reporting groups
11374225|NCT02823574|FG000|Participant Flow|Treatment A - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374226|NCT02823574|FG001|Participant Flow|Treatment B - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374227|NCT02823574|FG002|Participant Flow|Treatment A - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374228|NCT02823574|FG003|Participant Flow|Treatment B - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374229|NCT02823574|OG000|Outcome|Treatment A - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374230|NCT02823574|OG001|Outcome|Treatment B - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374231|NCT02823574|OG000|Outcome|Treatment A - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374232|NCT02823574|OG001|Outcome|Treatment B - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374233|NCT02823574|OG000|Outcome|Treatment A|Participants in both Platinum Refractory Subgroup and Platinum Eligible Subgroup treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
11374234|NCT02823574|OG001|Outcome|Treatment B|Participants in both Platinum Refractory Subgroup and Platinum Eligible Subgroup treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
11374235|NCT02823574|OG001|Outcome|Treatment B - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374236|NCT02823574|EG000|Reported Event|Treatment A - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374237|NCT02823574|EG001|Reported Event|Treatment B - Platinum Refractory Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11374238|NCT02823574|EG002|Reported Event|Treatment A - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W"
11374239|NCT02823574|EG003|Reported Event|Treatment B - Platinum Eligible Subgroup|"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.~Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W"
11190702|NCT02128217|OG000|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
11190703|NCT02128217|OG001|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
11374240|NCT02771990|BG000|Baseline|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~Sham transcranial direct current stimulation: sham stimulation"
11374241|NCT02771990|BG001|Baseline|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: 2 milliamp (mA) 20 minutes"
11374242|NCT02771990|BG002|Baseline|Total|Total of all reporting groups
11374243|NCT02771990|FG000|Participant Flow|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~Sham transcranial direct current stimulation: sham stimulation"
11374244|NCT02771990|FG001|Participant Flow|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: 2 milliamp (mA) 20 minutes"
11374245|NCT02771990|OG000|Outcome|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~Sham transcranial direct current stimulation: sham"
11374246|NCT02771990|OG001|Outcome|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: 2 milliamp (mA) 20 minutes"
11374247|NCT02771990|EG000|Reported Event|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~Sham transcranial direct current stimulation: sham stimultion"
11374248|NCT02771990|EG001|Reported Event|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: 2 milliamp (mA) 20 minutes"
11374249|NCT02743819|BG000|Baseline|Treatment|"Treatment with the combination of pembrolizumab and ipilimumab.~Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion.~Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses."
11374250|NCT02743819|FG000|Participant Flow|Treatment|"Treatment with the combination of pembrolizumab and ipilimumab.~Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion.~Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses."
11374251|NCT02743819|OG000|Outcome|Treatment|"Treatment with the combination of pembrolizumab and ipilimumab.~Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion.~Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses."
11374252|NCT02743819|EG000|Reported Event|Treatment|"Treatment with the combination of pembrolizumab and ipilimumab.~Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion.~Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses."
11190704|NCT02128217|OG000|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred 24 through to weeks after the end of treatment.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management."
11374253|NCT02729753|BG000|Baseline|CryoBalloon™ Swipe Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374254|NCT02729753|BG001|Baseline|CryoBalloon™ Full Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374255|NCT02729753|BG002|Baseline|Total|Total of all reporting groups
11374256|NCT02729753|FG000|Participant Flow|CryoBalloon™ Full Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374257|NCT02729753|FG001|Participant Flow|CryoBalloon Swipe Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374258|NCT02729753|OG000|Outcome|CryoBalloon™ Swipe Ablation System|To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374259|NCT02729753|OG001|Outcome|CryoBalloon™ Full Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374260|NCT02729753|OG000|Outcome|CryoBalloon™ Full Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374261|NCT02729753|OG001|Outcome|CryoBalloon™ Swipe Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374262|NCT02729753|OG001|Outcome|CryoBalloon™ Swipe Ablation System|To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374263|NCT02729753|EG000|Reported Event|CryoBalloon™ Full Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11374264|NCT02729753|EG001|Reported Event|CryoBalloon™ Swipe Ablation System|To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
11190705|NCT02128217|OG001|Outcome|Cohort 2: LDV/SOF for 8 Wks|"Follow-up through to occurred 24 weeks after the end of treatment.~Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF."
10850248|NCT00300781|EG000|Reported Event|Neratinib 240, Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
10850249|NCT00300781|EG001|Reported Event|Neratinib 240, No Prior Trastuzumab|Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
11376851|NCT02343120|OG004|Outcome|Parts 1 and 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
10963958|NCT00875056|EG002|Reported Event|Other Disease|Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
11190706|NCT02128217|OG000|Outcome|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred through to 24 weeks after the end of treatment.~Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
11376852|NCT02343120|OG000|Outcome|Part 1: Zanubrutinib|Five dose regimens of zanubrutinib (40 mg QD, 80 mg QD, 160 mg QD, 160 mg BID, and 320 mg QD) were evaluated.
10963959|NCT00875212|BG000|Baseline|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
11190707|NCT02128217|EG000|Reported Event|Cohort 1: SOF+Weight-based RBV for 12 Wks|"Follow-up occurred 24 weeks after the end of treatment. Ribavirin: Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.~Sofosbuvir: Participants received one 400 mg tablet of sofosbuvir orally every morning with food."
11190708|NCT02128217|EG001|Reported Event|Cohort 2: LDV/SOF for 8 Wks|Follow-up occurred 24 weeks after the end of treatment. Ledipasvir/Sofosbuvir: Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.
11374265|NCT02704130|BG000|Baseline|TAE + MWA Combination Therapy|"In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.~Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374266|NCT02704130|BG001|Baseline|MWA Monotherapy|"Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374267|NCT02704130|BG002|Baseline|Total|Total of all reporting groups
11374268|NCT02704130|FG000|Participant Flow|TAE + MWA Combination Therapy|"In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.~Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374269|NCT02704130|FG001|Participant Flow|MWA Monotherapy|"Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374270|NCT02704130|OG000|Outcome|TAE + MWA Combination Therapy|"In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.~Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11376853|NCT02343120|OG003|Outcome|Part 1 and Part 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376854|NCT02343120|OG004|Outcome|Part 1 and Part 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11190709|NCT02128230|BG000|Baseline|Study Treatment|MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
11376855|NCT02343120|OG002|Outcome|Part 1: 160 mg QD|Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to
11374271|NCT02704130|OG001|Outcome|MWA Monotherapy|"Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374272|NCT02704130|EG000|Reported Event|TAE + MWA Combination Therapy|"In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.~Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374273|NCT02704130|EG001|Reported Event|MWA Monotherapy|"Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.~Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors."
11374274|NCT02701192|BG000|Baseline|Coccygectomy Treatment|"Patients undergoing coccygectomy surgical procedure.~Coccygectomy: Patient receiving coccygectomy surgery."
11374275|NCT02701192|FG000|Participant Flow|Coccygectomy Treatment|"Patients undergoing coccygectomy surgical procedure.~Coccygectomy: Patient receiving coccygectomy surgery."
11374276|NCT02701192|OG000|Outcome|Coccygectomy Treatment|"Patients undergoing coccygectomy surgical procedure.~Coccygectomy: Patient receiving coccygectomy surgery."
11374277|NCT02701192|EG000|Reported Event|Coccygectomy Treatment|"Patients undergoing coccygectomy surgical procedure.~Coccygectomy: Patient receiving coccygectomy surgery."
11374278|NCT02685709|BG000|Baseline|Run-in Phase|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day"
11374279|NCT02685709|BG001|Baseline|RCT Phase - Oral|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day"
11374280|NCT02685709|BG002|Baseline|RCT Phase - Injectables|"Injectable somatostatin analogs (octreotide or lanreotide)~Injectable Somatostatin Analogs (octreotide or lanreotide): Octreotide - 10, 20, 30mg. Lanreotide 60,90, 120mg."
11374281|NCT02685709|BG003|Baseline|Combination Phase (Sub-study)|"Octreotide capsules plus cabergoline~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day~Cabergoline: Cabergoline - 3.5mg/week"
11374282|NCT02685709|BG004|Baseline|Total|Total of all reporting groups
11374283|NCT02685709|FG000|Participant Flow|Run-in Phase|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day determined by individual dose titration"
11374284|NCT02685709|FG001|Participant Flow|RCT Phase - Oral|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day"
11374285|NCT02685709|FG002|Participant Flow|RCT Phase - Injectables|"Injectable somatostatin analogs (octreotide or lanreotide)~Injectable Somatostatin Analogs (octreotide or lanreotide):~Octreotide- 10, 20, 30, 40 mg. Lanreotide- 60, 90, 120mg."
11374286|NCT02685709|FG003|Participant Flow|Combination Phase (Sub-study)|"Octreotide capsules plus cabergoline~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day~Cabergoline: Cabergoline - Up to 3.5mg/week"
11374287|NCT02685709|OG000|Outcome|RCT Phase - Oral|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day"
11374288|NCT02685709|OG001|Outcome|RCT Phase - Injectables|"Injectable somatostatin analogs (octreotide or lanreotide)~Injectable Somatostatin Analogs (octreotide or lanreotide): Octreotide - 10, 20, 30mg. Lanreotide 60,90, 120mg."
11374289|NCT02685709|OG001|Outcome|RCT Phase - Injectables|"Injectable somatostatin analogs (octreotide or lanreotide)~Injectable Somatostatin Analogs (octreotide or lanreotide):~Octreotide- 10, 20, 30, 40 mg. Lanreotide- 60, 90, 120mg."
11374290|NCT02685709|OG000|Outcome|Run-in Phase|"Oral octreotide capsules~Octreotide capsules: Octreotide capsules 40mg/day, 60mg/day, 80mg/day"
11374291|NCT02685709|EG000|Reported Event|Run-in Phase|"Oral octreotide capsules~Octreotide capsules"
11374292|NCT02685709|EG001|Reported Event|RCT Phase - Oral|"Oral octreotide capsules~Octreotide capsules"
11374293|NCT02685709|EG002|Reported Event|RCT Phase - Injectables|"Injectable somatostatin analogs (octreotide or lanreotide)~Octreotide capsules"
11374294|NCT02685709|EG003|Reported Event|Combination Phase (Sub-study)|"Octreotide capsules plus cabergoline~Octreotide capsules"
11374295|NCT02684851|BG000|Baseline|Placebo|"Inactive~Placebo: Placebo"
11374296|NCT02684851|BG001|Baseline|Tranexamic|"Tranexamic acid: anti-fibrinolytic agents~Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents"
11374297|NCT02684851|BG002|Baseline|Total|Total of all reporting groups
11374298|NCT02684851|FG000|Participant Flow|Placebo|"Inactive~Placebo: Placebo"
11374299|NCT02684851|FG001|Participant Flow|Tranexamic|"Tranexamic acid: anti-fibrinolytic agents~Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents"
11190710|NCT02128230|FG000|Participant Flow|Study Treatment|MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
11190711|NCT02128230|OG000|Outcome|Total Therapy 5B|Induction 1 - MEL-10+CFZ-TD-PACE, Optional Bridging with TD, First Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Inter-Therapy - MEL-20+CFZ-TD-PACE (75%), Optional Bridging with TD, Second Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Consolidation - CFZ-TD-PACE, Maintenance - CFZ-R(T)-D
11190712|NCT02128230|EG000|Reported Event|Study Treatment|MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
11190713|NCT02128269|BG000|Baseline|ALXN1007- Open Label Study|"ALXN1007~ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
11190714|NCT02128269|FG000|Participant Flow|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
11190715|NCT02128269|OG000|Outcome|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
11190716|NCT02128269|EG000|Reported Event|ALXN1007- Open Label Study|"ALXN1007~ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
11190717|NCT02128490|BG000|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190718|NCT02128490|BG001|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190719|NCT02128490|BG002|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190720|NCT02128490|BG003|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190721|NCT02128490|BG004|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190722|NCT02128490|BG005|Baseline|Total|Total of all reporting groups
11190723|NCT02128490|FG000|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190724|NCT02128490|FG001|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190725|NCT02128490|FG002|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190726|NCT02128490|FG003|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190727|NCT02128490|FG004|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11240518|NCT02480114|EG001|Reported Event|Arm II Standard of Care Plus Gabapentin|"Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.~Educational Intervention: Undergo oral care and pain management education session~Gabapentin: Given PO~Pain Therapy: Receive usual oral health care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Oxycodone/Acetaminophen: Analgesia~Hydrocodone/Acetaminophen: Analgesia~Fentanyl: Transdermal Analgesia~Ibuprofen: NSAID Analgesia~Magic Mouthwash: Oral Solution to treat mucositis"
11240519|NCT02480153|BG000|Baseline|Period 1: PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
11240520|NCT02480153|BG001|Baseline|Period 1: Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
11240521|NCT02480153|BG002|Baseline|Total|Total of all reporting groups
11240522|NCT02480153|FG000|Participant Flow|PF-06410293/PF-06410293/PF-06410293|Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
11240523|NCT02480153|FG001|Participant Flow|Adalimumab-EU/Adalimumab-EU/PF-06410293|Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
11240524|NCT02480153|FG002|Participant Flow|Adalimumab-EU/PF-06410293/PF-06410293|Period 1 (first dose to Week 26 predose assessments): participants were blindly randomized in a 1:1 ratio to receive PF-06410293 (a biosimilar to Humira) or adalimumab-EU (Humira from European Union) 40 mg every 2 weeks by subcutaneous injection. [This reporting group in Period 1 is a placeholder box only (not part of the 1:1 randomization).] All participants randomized into PF-06410293 arm continued to receive PF-06410293 in Periods 2 and 3. Period 2 (Week 26 dosing to Week 52 predose assessments): participants from adalimumab-EU arm were blindly re-randomized in a 1:1 ratio to remain on adalimumab-EU or transition to PF-06410293. Period 3 (Week 52 dosing to Week 78 end of treatment visit): all the remaining participants on adalimumab-EU were switched to open-label PF-06410293.
11240525|NCT02480153|OG000|Outcome|Period 1: PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
11240526|NCT02480153|OG001|Outcome|Period 1: Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
11240527|NCT02480153|OG000|Outcome|Period 1: PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1. PF-06410293 40 mg was administered every other week by subcutaneous injection in Period 1.
11240528|NCT02480153|OG001|Outcome|Period 1: Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1. Adalimumab-EU 40 mg was administered every other week by subcutaneous injection in Period 1.
11240529|NCT02480153|OG000|Outcome|Period 2: PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2. PF-06410293 40 mg was administered every other week by subcutaneous injection in both periods.
11240530|NCT02480153|OG001|Outcome|Period 2: Adalimumab-EU/Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and remained in the adalimumab-EU group in Period 2. Adalimumab-EU 40 mg was administered every other week by subcutaneous injection in both periods.
11240531|NCT02480153|OG002|Outcome|Period 2: Adalimumab-EU/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
11240532|NCT02480153|OG000|Outcome|Period 3: PF-06410293/PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2 and Period 3. PF-06410293 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11240533|NCT02480153|OG001|Outcome|Period 3: Adalimumab-EU/Adalimumab-EU/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, remained in the adalimumab-EU group in Period 2 and received PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11190728|NCT02128490|OG000|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190729|NCT02128490|OG001|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190730|NCT02128490|OG002|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11374300|NCT02684851|OG000|Outcome|Tranexamic|Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).
11374301|NCT02684851|OG001|Outcome|Placebo|Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
11374302|NCT02684851|OG000|Outcome|Tranexamic|"Tranexamic acid: anti-fibrinolytic agents~Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents"
11374303|NCT02684851|OG001|Outcome|Placebo|"Inactive~Placebo: Placebo"
11374304|NCT02684851|EG000|Reported Event|Tranexamic|Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).
11374305|NCT02684851|EG001|Reported Event|Placebo|Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
11374306|NCT02653482|BG000|Baseline|Dapagliflozin|"Dapagliflozin 10 mg daily~Dapagliflozin"
11374307|NCT02653482|BG001|Baseline|Dapagliflozin Matching Placebo|"Dapagliflozin matching placebo 10 mg daily~Dapagliflozin matching placebo"
11374308|NCT02653482|BG002|Baseline|Total|Total of all reporting groups
11374309|NCT02653482|FG000|Participant Flow|Dapagliflozin|"Dapagliflozin 10 mg daily~Dapagliflozin"
11374310|NCT02653482|FG001|Participant Flow|Dapagliflozin Matching Placebo|"Dapagliflozin matching placebo 10 mg daily~Dapagliflozin matching placebo"
11374311|NCT02653482|OG000|Outcome|Dapagliflozin|"Dapagliflozin 10 mg daily~Dapagliflozin"
11374312|NCT02653482|OG001|Outcome|Dapagliflozin Matching Placebo|"Dapagliflozin matching placebo 10 mg daily~Dapagliflozin matching placebo"
11374313|NCT02653482|EG000|Reported Event|Dapagliflozin|"Dapagliflozin 10 mg daily~Dapagliflozin"
11374314|NCT02653482|EG001|Reported Event|Dapagliflozin Matching Placebo|"Dapagliflozin matching placebo 10 mg daily~Dapagliflozin matching placebo"
11374315|NCT02632409|BG000|Baseline|Placebo|Placebo
11374316|NCT02632409|BG001|Baseline|Nivolumab|Nivolumab 240mg IV Q2W
11374317|NCT02632409|BG002|Baseline|Total|Total of all reporting groups
11374318|NCT02632409|FG000|Participant Flow|Placebo|Placebo
11190731|NCT02128490|OG003|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190732|NCT02128490|OG004|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190733|NCT02128490|EG000|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190734|NCT02128490|EG001|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190735|NCT02128490|EG002|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11190736|NCT02128490|EG003|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11374319|NCT02632409|FG001|Participant Flow|Nivolumab|Nivolumab 240mg IV Q2W
11374320|NCT02632409|OG000|Outcome|Placebo|Placebo
11374321|NCT02632409|OG001|Outcome|Nivolumab|Nivolumab 240mg IV Q2W
11374322|NCT02632409|EG000|Reported Event|Placebo|Placebo
11374323|NCT02632409|EG001|Reported Event|Nivolumab|Nivolumab 240mg IV Q2W
11374324|NCT02612194|BG000|Baseline|Cohort 1|"c-MET high (> 50%), RON null (0-9%)~Crizotinib: All arms will receive crizotinib."
11374325|NCT02612194|BG001|Baseline|Cohort 2|"c-MET + (10-100%), RON + (10-100%)~Crizotinib: All arms will receive crizotinib."
11374326|NCT02612194|BG002|Baseline|Cohort 3|"c-MET null (0-9%), RON + (10-100%)~Crizotinib: All arms will receive crizotinib."
11374327|NCT02612194|BG003|Baseline|Total|Total of all reporting groups
11374328|NCT02612194|FG000|Participant Flow|Cohort 1|"c-MET high (> 50%), RON null (0-9%)~Crizotinib: All arms will receive crizotinib."
11374329|NCT02612194|FG001|Participant Flow|Cohort 2|"c-MET + (10-100%), RON + (10-100%)~Crizotinib was administered orally at 250 mg twice daily."
11374330|NCT02612194|FG002|Participant Flow|Cohort 3|"c-MET null (0-9%), RON + (10-100%)~Crizotinib was administered orally at 250 mg twice daily."
11374331|NCT02612194|OG000|Outcome|Total Enrolled Study Cohort|This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
11374332|NCT02612194|EG000|Reported Event|Cohort 1|"c-MET high (> 50%), RON null (0-9%)~Crizotinib: All arms will receive crizotinib."
11190737|NCT02128490|EG004|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11374333|NCT02612194|EG001|Reported Event|Cohort 2|"c-MET + (10-100%), RON + (10-100%)~Crizotinib: All arms will receive crizotinib."
11374334|NCT02612194|EG002|Reported Event|Cohort 3|"c-MET null (0-9%), RON + (10-100%)~Crizotinib: All arms will receive crizotinib."
11374335|NCT02612194|EG003|Reported Event|Total|Pooled Cohorts 1, 2, and 3
11190738|NCT02128542|BG000|Baseline|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190739|NCT02128542|BG001|Baseline|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190740|NCT02128542|BG002|Baseline|Total|Total of all reporting groups
11190741|NCT02128542|FG000|Participant Flow|SOF+RBV 12 Weeks (TN)|Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190742|NCT02128542|FG001|Participant Flow|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190743|NCT02128542|OG000|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190744|NCT02128542|OG001|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190745|NCT02128542|OG000|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190746|NCT02128542|OG000|Outcome|SOF+RBV 12 Weeks (TN)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190747|NCT02128542|OG001|Outcome|SOF+RBV 12 Weeks (TE)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190748|NCT02128542|EG000|Reported Event|SOF+RBV 12 Weeks (All Participants)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
11190749|NCT02128724|BG000|Baseline|Dose Escalation Phase: Cohort 1|Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190750|NCT02128724|BG001|Baseline|Dose Escalation Phase: Cohort 2|Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190751|NCT02128724|BG002|Baseline|Dose Escalation Phase: Cohort 3|Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11374336|NCT02586207|BG000|Baseline|Single Arm|"Pembrolizumab + Cisplatin + Radiation~pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.~Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36~Radiation: 70 Gy fractionated over 35 days"
11374337|NCT02586207|FG000|Participant Flow|Single Arm|"Pembrolizumab + Cisplatin + Radiation~pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.~Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36~Radiation: 70 Gy fractionated over 35 days"
11374338|NCT02586207|OG000|Outcome|Single Arm|"Pembrolizumab + Cisplatin + Radiation~pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.~Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36~Radiation: 70 Gy fractionated over 35 days"
10963960|NCT00875212|FG000|Participant Flow|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
11240534|NCT02480153|OG002|Outcome|Period 3: Adalimumab-EU/PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 from Period 2 and continued on PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11240535|NCT02480153|OG003|Outcome|Period 3 Total|This reporting group refers to the participants who entered Period 3, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
11190752|NCT02128724|BG003|Baseline|Dose Expansion Phase|Patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190753|NCT02128724|BG004|Baseline|Total|Total of all reporting groups
11374339|NCT02586207|EG000|Reported Event|Single Arm|"Pembrolizumab + Cisplatin + Radiation~pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.~Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36~Radiation: 70 Gy fractionated over 35 days"
11374340|NCT02542397|BG000|Baseline|Pharmacogenomic Testing|Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
11190754|NCT02128724|FG000|Participant Flow|Cohort 1: 50mg Buparlisib|"These patients were treated with 50mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules."
11190755|NCT02128724|FG001|Participant Flow|Cohort 2: 80mg Buparlisib|"These patients were treated with 80mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules."
11190756|NCT02128724|FG002|Participant Flow|Cohort 3: 100mg Buparlisib|"These patients were treated with 100mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules."
11190757|NCT02128724|FG003|Participant Flow|100mg Buparlisib Expansion Cohort|"These patients were treated with 100mg buparlisib OD for a total of fourteen days, after 100mg buparlisib OD was determined to be the MTD. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules."
11190758|NCT02128724|OG000|Outcome|Dose Escalation Phase: Cohort 1|Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190759|NCT02128724|OG001|Outcome|Dose Escalation Phase: Cohort 2|Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190760|NCT02128724|OG002|Outcome|Dose Escalation Phase: Cohort 3|Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11240536|NCT02480153|OG001|Outcome|Period 1: Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where Adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
11374341|NCT02542397|FG000|Participant Flow|Pharmacogenomic Testing|Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
11374342|NCT02542397|OG000|Outcome|Pharmacogenomic Testing: Evaluable Population|Enrolled subjects providing pain scores at Baseline Assessment (Day 0) and Final Assessment (Day 30 +/- 7).
11190761|NCT02128724|OG002|Outcome|Dose Escalation Phase: Cohort 3 and Dose Expansion Phase|"Dose Escalation Phase: Cohort 3 represents patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~The Dose Expansion Phase represents patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period."
11374343|NCT02542397|OG000|Outcome|Pharmacogenomic Testing: Evaluable Population|Enrolled subjects providing pain scores at baseline assessment and a final assessment within 30 +/- 7 days.
11374344|NCT02542397|EG000|Reported Event|Pharmacogenomic Testing|Cancer outpatients with uncontrolled malignant pain undergo a pharmacogenomic panel (by buccal swab) with the intent of informing pain management.
11374345|NCT02519777|BG000|Baseline|Arm A: Placebo MVC and Placebo DTG|"In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374346|NCT02519777|BG001|Baseline|Arm B: DTG and Placebo MVC|"In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374347|NCT02519777|BG002|Baseline|Arm C: MVC and DTG|"In addition to their existing ART regimens, participants in Arm C received MVC and DTG~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen~Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen"
11374348|NCT02519777|BG003|Baseline|Total|Total of all reporting groups
11374349|NCT02519777|FG000|Participant Flow|Arm A: Placebo MVC and Placebo DTG|"In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374350|NCT02519777|FG001|Participant Flow|Arm B: DTG and Placebo MVC|"In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374351|NCT02519777|FG002|Participant Flow|Arm C: MVC and DTG|"In addition to their existing ART regimens, participants in Arm C received MVC and DTG~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen~Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen"
11374352|NCT02519777|OG000|Outcome|Arm A: Placebo MVC and Placebo DTG|"In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374353|NCT02519777|OG001|Outcome|Arm B: DTG and Placebo MVC|"In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374354|NCT02519777|OG002|Outcome|Arm C: MVC and DTG|"In addition to their existing ART regimens, participants in Arm C received MVC and DTG~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen~Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen"
11374355|NCT02519777|EG000|Reported Event|Arm A (Placebo DTG/Placebo MVC)|"In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374356|NCT02519777|EG001|Reported Event|Arm B (DTG/Placebo MVC)|"In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.~Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen"
11374357|NCT02519777|EG002|Reported Event|Arm C (DTG/MVC)|"In addition to their existing ART regimens, participants in Arm C received MVC and DTG~Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen~Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen"
11374358|NCT02484443|BG000|Baseline|Treatment (Sargramostim and Dinutuximab)|Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
11374359|NCT02484443|FG000|Participant Flow|Treatment (Sargramostim and Dinutuximab)|Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
11374360|NCT02484443|OG000|Outcome|Treatment (Sargramostim and Dinutuximab)|Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
11374361|NCT02484443|EG000|Reported Event|Treatment (Sargramostim and Dinutuximab)|Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
11374362|NCT02395666|BG000|Baseline|Stratum 1|"Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374363|NCT02395666|BG001|Baseline|Stratum 2|"Subjects that are in remission after any previous relapse or refractory therapy.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374364|NCT02395666|BG002|Baseline|Total|Total of all reporting groups
11374365|NCT02395666|FG000|Participant Flow|Stratum 1|"Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374366|NCT02395666|FG001|Participant Flow|Stratum 2|"Subjects that are in remission after any previous relapse or refractory therapy.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374367|NCT02395666|OG000|Outcome|Stratum 1|"Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374368|NCT02395666|OG001|Outcome|Stratum 2|"Subjects that are in remission after any previous relapse or refractory therapy.~Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374369|NCT02395666|OG000|Outcome|DFMO Twice Daily|"Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.~DFMO: Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle."
11374370|NCT02395666|OG000|Outcome|GG, GT, TT|Tests of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.
11374371|NCT02395666|OG001|Outcome|GG or GT, TT|Tests of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.
11374372|NCT02395666|OG002|Outcome|GG, GT or TT|Tests of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.
11374373|NCT02395666|OG000|Outcome|Study Subjects Consented to PK Collection|Includes study subjects from either stratum that signed an optional consent to have PK's collected
11374374|NCT02395666|EG000|Reported Event|All Study Subjects|All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.
11374375|NCT02357810|BG000|Baseline|Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pazopanib Hydrochloride: Given PO~Oral Topotecan Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11374376|NCT02357810|FG000|Participant Flow|Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pazopanib Hydrochloride: Given PO~Oral Topotecan Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11374377|NCT02357810|OG000|Outcome|Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pazopanib Hydrochloride: Given PO~Oral Topotecan Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11374378|NCT02357810|EG000|Reported Event|Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pazopanib Hydrochloride: Given PO~Oral Topotecan Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11374379|NCT02343549|BG000|Baseline|Planned RT + TMZ + BEV + NovoTTF100A Device|Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
11374380|NCT02343549|FG000|Participant Flow|Planned RT + TMZ + BEV + NovoTTF100A Device|Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
11374381|NCT02343549|OG000|Outcome|Planned RT + TMZ + BEV + NovoTTF100A Device|Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
11374382|NCT02343549|EG000|Reported Event|Planned RT + TMZ + BEV + NovoTTF100A Device|Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
11374383|NCT02339233|BG000|Baseline|Epidural Stimulator|"Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord~Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping."
11374384|NCT02339233|FG000|Participant Flow|Epidural Stimulator|"Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord~Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping."
11374385|NCT02339233|OG000|Outcome|Epidural Stimulator|"Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord~Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping."
11374386|NCT02339233|EG000|Reported Event|Epidural Stimulator|"Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord~Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping."
11374387|NCT02328105|BG000|Baseline|Carboplatin + Abraxane|Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
11374388|NCT02328105|FG000|Participant Flow|Carboplatin + Abraxane|Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
11374389|NCT02328105|OG000|Outcome|Carboplatin + Abraxane|Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
11374390|NCT02328105|EG000|Reported Event|Carboplatin + Abraxane|Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
11374391|NCT02327195|BG000|Baseline|Methylphenidate|"Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery~Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)"
11374392|NCT02327195|BG001|Baseline|Placebo|"20 mg Placebo (PO) given 2 hours prior to surgery~Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery"
11374393|NCT02327195|BG002|Baseline|Total|Total of all reporting groups
11374394|NCT02327195|FG000|Participant Flow|Methylphenidate|"Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery~Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)"
11374395|NCT02327195|FG001|Participant Flow|Placebo|"20 mg Placebo (PO) given 2 hours prior to surgery~Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery"
11374396|NCT02327195|OG000|Outcome|Methylphenidate|"Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery~Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)"
11374397|NCT02327195|OG001|Outcome|Placebo|"20 mg Placebo (PO) given 2 hours prior to surgery~Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery"
11374398|NCT02327195|EG000|Reported Event|Methylphenidate|"Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery~Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)"
11374399|NCT02327195|EG001|Reported Event|Placebo|"20 mg Placebo (PO) given 2 hours prior to surgery~Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery"
11374400|NCT02315066|BG000|Baseline|Part A1: PF-04518600 0.01mg/kg|Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374401|NCT02315066|BG001|Baseline|Part A1: PF-04518600 0.1mg/kg|Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374402|NCT02315066|BG002|Baseline|Part A1: PF-04518600 0.3mg/kg|Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374403|NCT02315066|BG003|Baseline|Part A1: PF-04518600 1.5mg/kg|Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374404|NCT02315066|BG004|Baseline|Part A1: PF-04518600 3.0mg/kg|Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374405|NCT02315066|BG005|Baseline|Part A1: PF-04518600 10mg/kg|Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374406|NCT02315066|BG006|Baseline|Part A2: PF-04518600 30mg|Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374407|NCT02315066|BG007|Baseline|Part A2: PF-04518600 250mg|Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374408|NCT02315066|BG008|Baseline|Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374409|NCT02315066|BG009|Baseline|Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374410|NCT02315066|BG010|Baseline|Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374411|NCT02315066|BG011|Baseline|Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374412|NCT02315066|BG012|Baseline|Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374413|NCT02315066|BG013|Baseline|Part B2: PF-04518600 30mg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374414|NCT02315066|BG014|Baseline|Total|Total of all reporting groups
11374415|NCT02315066|FG000|Participant Flow|Part A1: PF-04518600 0.01mg/kg|Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374416|NCT02315066|FG001|Participant Flow|Part A1: PF-04518600 0.1mg/kg|Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374417|NCT02315066|FG002|Participant Flow|Part A1: PF-04518600 0.3mg/kg|Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374418|NCT02315066|FG003|Participant Flow|Part A1: PF-04518600 1.5mg/kg|Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374419|NCT02315066|FG004|Participant Flow|Part A1: PF-04518600 3.0mg/kg|Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374420|NCT02315066|FG005|Participant Flow|Part A1: PF-04518600 10mg/kg|Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374421|NCT02315066|FG006|Participant Flow|Part A2: PF-04518600 30mg|Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374422|NCT02315066|FG007|Participant Flow|Part A2: PF-04518600 250mg|Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374423|NCT02315066|FG008|Participant Flow|Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374424|NCT02315066|FG009|Participant Flow|Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374425|NCT02315066|FG010|Participant Flow|Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11376856|NCT02343120|OG000|Outcome|Part 1 and Part 2: Overall|The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
11374426|NCT02315066|FG011|Participant Flow|Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374427|NCT02315066|FG012|Participant Flow|Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374428|NCT02315066|FG013|Participant Flow|Part B2: PF-04518600 30mg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374429|NCT02315066|OG000|Outcome|Part A1: PF-04518600 0.01mg/kg|Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374430|NCT02315066|OG001|Outcome|Part A1: PF-04518600 0.1mg/kg|Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374431|NCT02315066|OG002|Outcome|Part A1: PF-04518600 0.3mg/kg|Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374432|NCT02315066|OG003|Outcome|Part A1: PF-04518600 1.5mg/kg|Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374433|NCT02315066|OG004|Outcome|Part A1: PF-04518600 3.0mg/kg|Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374434|NCT02315066|OG005|Outcome|Part A1: PF-04518600 10mg/kg|Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374435|NCT02315066|OG006|Outcome|Part A2: PF-04518600 30mg|Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374436|NCT02315066|OG007|Outcome|Part A2: PF-04518600 250mg|Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374437|NCT02315066|OG000|Outcome|Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374438|NCT02315066|OG001|Outcome|Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374439|NCT02315066|OG002|Outcome|Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374440|NCT02315066|OG003|Outcome|Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374441|NCT02315066|OG004|Outcome|Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374442|NCT02315066|OG005|Outcome|Part B2: PF-04518600 30mg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374443|NCT02315066|EG000|Reported Event|Part A1: PF-04518600 0.01mg/kg|Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374444|NCT02315066|EG001|Reported Event|Part A1: PF-04518600 0.1mg/kg|Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374445|NCT02315066|EG002|Reported Event|Part A1: PF-04518600 0.3mg/kg|Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374446|NCT02315066|EG003|Reported Event|Part A1: PF-04518600 1.5mg/kg|Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374447|NCT02315066|EG004|Reported Event|Part A1: PF-04518600 3.0mg/kg|Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374448|NCT02315066|EG005|Reported Event|Part A1: PF-04518600 10mg/kg|Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374449|NCT02315066|EG006|Reported Event|Part A2: PF-04518600 30mg|Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374450|NCT02315066|EG007|Reported Event|Part A2: PF-04518600 250mg|Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11374451|NCT02315066|EG008|Reported Event|Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374452|NCT02315066|EG009|Reported Event|Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374453|NCT02315066|EG010|Reported Event|Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374454|NCT02315066|EG011|Reported Event|Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374455|NCT02315066|EG012|Reported Event|Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg|Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374456|NCT02315066|EG013|Reported Event|Part B2: PF-04518600 30mg + PF-05082566 20mg|Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
11374457|NCT02265367|BG000|Baseline|Levomilnacipran Then Placebo|In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.
11374458|NCT02265367|BG001|Baseline|Placebo Then Levomilnacipran|In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.
11374459|NCT02265367|BG002|Baseline|Total|Total of all reporting groups
11374460|NCT02265367|FG000|Participant Flow|Levomilnacipran Then Placebo|In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.
11374461|NCT02265367|FG001|Participant Flow|Placebo Then Levomilnacipran|"In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.~Placebo"
11374462|NCT02265367|OG000|Outcome|Levomilnacipran|In this three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week.
11374463|NCT02265367|OG001|Outcome|Placebo|In this three week period, baseline measures are obtained during the first week, placebo during the second week and effects on smoking behavior during the third week
11374464|NCT02265367|EG000|Reported Event|Levomilnacipran|"In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week~Levomilnacipran"
11374465|NCT02265367|EG001|Reported Event|Placebo|"In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week~Placebo"
11374466|NCT02256631|BG000|Baseline|Dose Group 1|"Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374467|NCT02256631|BG001|Baseline|Dose Group 2|"Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374468|NCT02256631|BG002|Baseline|Dose Group 3|"Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.~VRC01: Administered by subcutaneous injection in the thigh"
11374469|NCT02256631|BG003|Baseline|Dose Group 4, Cohort 1|"Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374470|NCT02256631|BG004|Baseline|Dose Group 4, Cohort 2|"Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374471|NCT02256631|BG005|Baseline|Dose Group 5, Cohort 1|"Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374472|NCT02256631|BG006|Baseline|Dose Group 5, Cohort 2|"Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374473|NCT02256631|BG007|Baseline|Total|Total of all reporting groups
11374474|NCT02256631|FG000|Participant Flow|Dose Group 1|"Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374475|NCT02256631|FG001|Participant Flow|Dose Group 2|"Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374476|NCT02256631|FG002|Participant Flow|Dose Group 3|"Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.~VRC01: Administered by subcutaneous injection in the thigh"
11374477|NCT02256631|FG003|Participant Flow|Dose Group 4, Cohort 1|"Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374478|NCT02256631|FG004|Participant Flow|Dose Group 4, Cohort 2|"Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374479|NCT02256631|FG005|Participant Flow|Dose Group 5, Cohort 1|"Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374480|NCT02256631|FG006|Participant Flow|Dose Group 5, Cohort 2|"Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374481|NCT02256631|OG000|Outcome|Dose Group 1|"Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374482|NCT02256631|OG001|Outcome|Dose Group 2|"Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.~VRC01: Administered by subcutaneous injection in the thigh"
11374483|NCT02256631|OG002|Outcome|Dose Group 3|"Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.~VRC01: Administered by subcutaneous injection in the thigh"
11374484|NCT02256631|OG003|Outcome|Dose Group 4, Cohort 1|"Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374485|NCT02256631|OG004|Outcome|Dose Group 4, Cohort 2|"Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.~VRC01LS: Administered by subcutaneous injection in the thigh"
11374486|NCT02256631|OG005|Outcome|Dose Group 5, Cohort 1|"Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374487|NCT02256631|OG006|Outcome|Dose Group 5, Cohort 2|"Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.~VRC07-523LS: Administered by subcutaneous injection in the thigh"
11374488|NCT02256631|EG000|Reported Event|Dose Group 1|Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
11374489|NCT02256631|EG001|Reported Event|Dose Group 2|Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
11374490|NCT02256631|EG002|Reported Event|Dose Group 3|Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
11374491|NCT02256631|EG003|Reported Event|Dose Group 4, Cohort 1|Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
11374492|NCT02256631|EG004|Reported Event|Dose Group 4, Cohort 2|Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
11374493|NCT02256631|EG005|Reported Event|Dose Group 5, Cohort 1|Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
11374494|NCT02256631|EG006|Reported Event|Dose Group 5, Cohort 2|Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
11374495|NCT02173379|BG000|Baseline|Absorb BVS|Subjects receiving public) Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System
11374496|NCT02173379|BG001|Baseline|XIENCE|Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
11374497|NCT02173379|BG002|Baseline|Total|Total of all reporting groups
11374498|NCT02173379|FG000|Participant Flow|Absorb BVS|Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System
11374499|NCT02173379|FG001|Participant Flow|XIENCE|Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
11374500|NCT02173379|OG000|Outcome|Absorb BVS|Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
11374501|NCT02173379|OG001|Outcome|XIENCE|Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
11374502|NCT02173379|OG000|Outcome|Absorb BVS|Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System
11374503|NCT02173379|EG000|Reported Event|Absorb BVS|Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
11374504|NCT02173379|EG001|Reported Event|XIENCE|Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
11374505|NCT02129348|BG000|Baseline|Lithium Treatment Group|"The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Lithium"
11374506|NCT02129348|BG001|Baseline|Placebo Group|"The patient will be started on placebo 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on sham lithium blood level. Blood will be drawn for sham lithium levels at weeks 2, 4, 6, 8, and 12. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Placebo"
11374507|NCT02129348|BG002|Baseline|Total|Total of all reporting groups
11374508|NCT02129348|FG000|Participant Flow|Lithium Treatment Group|"The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Lithium"
11374509|NCT02129348|FG001|Participant Flow|Placebo Group|"The patient will be started on placebo 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on sham lithium blood level. Blood will be drawn for sham lithium levels at weeks 2, 4, 6, 8, and 12. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Placebo"
11374510|NCT02129348|OG000|Outcome|Lithium Treatment Group|"The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Lithium"
11374511|NCT02129348|OG001|Outcome|Placebo Group|"The patient will be started on placebo 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on sham lithium blood level. Blood will be drawn for sham lithium levels at weeks 2, 4, 6, 8, and 12. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Placebo"
11374512|NCT02129348|EG000|Reported Event|Lithium Treatment Group|"The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Lithium"
11190762|NCT02128724|EG000|Reported Event|Dose Escalation Phase: Cohort 1|Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11190763|NCT02128724|EG001|Reported Event|Dose Escalation Phase: Cohort 2|Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
11240537|NCT02480153|OG000|Outcome|Sub-study: PF-06410293 PFP|Participants received 6 consecutive bi-weekly PF-06410293 doses over a period of 10 weeks (Week 56 to Week 66) using the PFP device provided by the sponsor. The first, third and sixth injections were administered at the study site under the supervision of the investigator or a designated observer. All other injections (the second, fourth and fifth) were administered at home.
11374513|NCT02129348|EG001|Reported Event|Placebo Group|"The patient will be started on placebo 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on sham lithium blood level. Blood will be drawn for sham lithium levels at weeks 2, 4, 6, 8, and 12. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).~Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.~Placebo"
11374514|NCT02080260|BG000|Baseline|Single Arm, Regorafenib|"Oral Regorafenib~regorafenib: Single agent drug therapy with regorafenib"
11374515|NCT02080260|FG000|Participant Flow|Single Arm, Regorafenib|"Oral regorafenib in advanced previously treated pancreatic cancer.~regorafenib: Single agent drug therapy with regorafenib starting at 120mg per day for 3 weeks out 4, with dose adjustments based upon tolerance"
11374516|NCT02080260|OG000|Outcome|Single Arm, Regorafenib|"Oral Regorafenib~regorafenib: Single agent drug therapy with regorafenib"
11374517|NCT02080260|EG000|Reported Event|Single Arm, Regorafenib|"Oral Regorafenib~regorafenib: Single agent drug therapy with regorafenib"
11374518|NCT02051933|BG000|Baseline|Botulinum Toxin Type A|"Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374519|NCT02051933|BG001|Baseline|0.9% Sodium Chloride|"Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374520|NCT02051933|BG002|Baseline|Total|Total of all reporting groups
11374521|NCT02051933|FG000|Participant Flow|Botox|"Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374522|NCT02051933|FG001|Participant Flow|Placebo|"Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374523|NCT02051933|OG000|Outcome|Botox|"At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374524|NCT02051933|OG001|Outcome|Placebo|"Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374525|NCT02051933|OG000|Outcome|Botox|"See Botox intervention description:~Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374526|NCT02051933|OG001|Outcome|Placebo|"See Placebo Intervention Description~Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
10850250|NCT00300885|BG000|Baseline|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
11374527|NCT02051933|OG000|Outcome|Botox|"See Botox intervention description:~At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374528|NCT02051933|OG000|Outcome|Botox|"Botulinum toxin A solution~Botulinum toxin A: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374529|NCT02051933|OG001|Outcome|Placebo|"0.9% sodium chloride solution~Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374530|NCT02051933|EG000|Reported Event|Botox|"Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374531|NCT02051933|EG001|Reported Event|Placebo|"See Placebo Intervention Description~Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
11374532|NCT02047929|BG000|Baseline|Facilitator-Led Participant Owned (FLOW) Dissemination|"This approach to dissemination allows clinics some freedom to tailor the SDM Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), identified by both the Institute of Medicine and the Patient-Centered Outcomes Research Institute as an important new means of improving patient outcomes. In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination."
11374533|NCT02047929|BG001|Baseline|Traditional Dissemination (Active Diffusion)|"The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, traditional dissemination. For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma SDM Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit."
11374534|NCT02047929|BG002|Baseline|Control|A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.
11374535|NCT02047929|BG003|Baseline|Total|Total of all reporting groups
11376857|NCT02343120|OG003|Outcome|Part 1 and Part 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
10850251|NCT00300885|BG001|Baseline|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
11374536|NCT02047929|FG000|Participant Flow|Facilitator-Led Participant Owned (FLOW) Dissemination|"This approach to dissemination allows clinics some freedom to tailor the SDM Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), identified by both the Institute of Medicine and the Patient-Centered Outcomes Research Institute as an important new means of improving patient outcomes. In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination."
11374537|NCT02047929|FG001|Participant Flow|Traditional Dissemination (Active Diffusion)|"The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, traditional dissemination. For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma SDM Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit."
11374538|NCT02047929|FG002|Participant Flow|Control|A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.
11374539|NCT02047929|OG000|Outcome|Facilitator-Led|"This approach to dissemination allows clinics some freedom to tailor the Asthma Shared Decision Making (SDM) Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. The research team for this proposal was funded by the Agency for Health Care Research and Quality to build, disseminate and evaluate a novel Asthma SDM Toolkit - The Asthma Comparative Effectiveness Study. The Toolkit development was completed in 2010 and has been in evaluation for"
11374540|NCT02047929|OG001|Outcome|Traditional|"For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma Shared Decision Making (SDM) Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical te"
11374541|NCT02047929|OG000|Outcome|Facilitator-Led Participant Owned (FLOW) Dissemination|"This approach to dissemination allows clinics some freedom to tailor the SDM Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), identified by both the Institute of Medicine and the Patient-Centered Outcomes Research Institute as an important new means of improving patient outcomes. In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination."
11374542|NCT02047929|OG001|Outcome|Traditional Dissemination (Active Diffusion)|"The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, traditional dissemination. For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma SDM Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit."
11374543|NCT02047929|OG002|Outcome|Control|A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.
10850252|NCT00300885|BG002|Baseline|Total|Total of all reporting groups
11240538|NCT02480153|EG000|Reported Event|Period 1: PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1, where PF-06410293 40 mg was administered every other week by subcutaneous injection.
11240539|NCT02480153|EG001|Reported Event|Period 1: Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, where adalimumab-EU 40 mg was administered every other week by subcutaneous injection.
11374544|NCT02047929|OG001|Outcome|Traditional|"We have defined this type of dissemination, traditional dissemination. For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma Shared Decision Making (SDM) Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical te"
11374545|NCT02047929|EG000|Reported Event|Facilitator-Led Participant Owned (FLOW) Dissemination|"This approach to dissemination allows clinics some freedom to tailor the SDM Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.~Asthma Shared Decision Making (SDM) Toolkit: A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), identified by both the Institute of Medicine and the Patient-Centered Outcomes Research Institute as an important new means of improving patient outcomes. In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination."
11374546|NCT02047929|EG001|Reported Event|Traditional Dissemination (Active Diffusion)|"The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, traditional dissemination. For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma SDM Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit."
11374547|NCT02047929|EG002|Reported Event|Control|A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.
11374548|NCT01999569|BG000|Baseline|Control|Control cycle. Then letrozole cycle
11374549|NCT01999569|FG000|Participant Flow|Control Then Letrozole|Control cycle. Then letrozole cycle
11374550|NCT01999569|OG000|Outcome|Control|Control cycle
11374551|NCT01999569|OG001|Outcome|Letrozole Treatment Cycle|
11374552|NCT01999569|OG000|Outcome|Control|Control cycle.
11374553|NCT01999569|EG000|Reported Event|Control|Control cycle. No intervention.
11374554|NCT01999569|EG001|Reported Event|Letrozole|"5mg daily~Letrozole: Letrozole administered daily through the time of ovulation."
11374555|NCT01969812|BG000|Baseline|Evie Slow-Release Insemination Device|"Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter.~Evie Slow-release Insemination Device"
11190764|NCT02128724|EG002|Reported Event|Dose Escalation Phase: Cohort 3 and Dose Expansion Phase|"Dose Escalation Phase: Cohort 3 consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.~The Dose Expansion Phase consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period."
11190765|NCT02128763|BG000|Baseline|Omega-3 Supplements|"Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps~Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day"
11374556|NCT01969812|BG001|Baseline|Traditional Intrauterine Insemination|"Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene).~Traditional Intrauterine Insemination"
11374557|NCT01969812|BG002|Baseline|Total|Total of all reporting groups
11374558|NCT01969812|FG000|Participant Flow|Evie Slow-Release Insemination Device|"Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter.~Evie Slow-release Insemination Device"
11374559|NCT01969812|FG001|Participant Flow|Traditional Intrauterine Insemination|"Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene).~Traditional Intrauterine Insemination"
11190766|NCT02128763|BG001|Baseline|Placebo|"Olive oil-5 gelcaps per day~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190767|NCT02128763|BG002|Baseline|Total|Total of all reporting groups
10850253|NCT00300885|FG000|Participant Flow|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
11190768|NCT02128763|FG000|Participant Flow|Omega-3 Supplements|"Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps~Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day"
11190769|NCT02128763|FG001|Participant Flow|Placebo|"Olive oil-5 gelcaps per day containing a total of 5 grams of refined olive oil~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190770|NCT02128763|OG000|Outcome|Omega-3 Supplements|"Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps~Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day"
11190771|NCT02128763|OG001|Outcome|Placebo (5 Gms of Refined Olive Oil/Day)|"Olive oil-5 gelcaps per day~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190772|NCT02128763|OG001|Outcome|Placebo (5 Gms of Refined Olive Oil/Day)|"Olive oil-5 gelcaps per day (5 gms of refined olive oil/day)~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190773|NCT02128763|OG001|Outcome|Placebo (5 Gms Refined Olive Oil/Day)|"Olive oil-5 gelcaps per day~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190774|NCT02128763|OG001|Outcome|Placebo|"Olive oil-5 gelcaps per day~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190775|NCT02128763|EG000|Reported Event|Omega-3 Supplements|"Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps~Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day"
11190776|NCT02128763|EG001|Reported Event|Placebo|"Olive oil-5 gelcaps per day~Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps"
11190777|NCT02128828|BG000|Baseline|Cenicriviroc|"cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily~cenicriviroc: cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc"
11374560|NCT01969812|OG000|Outcome|Evie Slow-Release Insemination Device|"Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter.~Evie Slow-release Insemination Device"
11374561|NCT01969812|OG001|Outcome|Traditional Intrauterine Insemination|"Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene).~Traditional Intrauterine Insemination"
11374562|NCT01969812|EG000|Reported Event|Evie Slow-Release Insemination Device|"Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter.~Evie Slow-release Insemination Device"
11374563|NCT01969812|EG001|Reported Event|Traditional Intrauterine Insemination|"Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene).~Traditional Intrauterine Insemination"
11374564|NCT01959464|BG000|Baseline|Crinone Vaginal Progesterone Gel Then Placebo|"Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.~On the evening of day 3, the female will insert the applicator into the vagina, administer the Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to placebo."
11374565|NCT01959464|BG001|Baseline|Placebo Vaginal Gel Then Crinone|The couple will be given a prefilled applicator containing placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to Crinone.
11374566|NCT01959464|BG002|Baseline|Total|Total of all reporting groups
11374567|NCT01959464|FG000|Participant Flow|Placebo Vaginal Gel Then Crinone|The couple will be given a prefilled applicator containing placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. Then they will be crossed over to Crinone vaginal gel.
11374568|NCT01959464|FG001|Participant Flow|Crinone Vaginal Progesterone Gel Then Placebo|"Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.~On the evening of day 3, the female will insert the applicator into the vagina, administer the Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then subject will cross over to placebo"
11374569|NCT01959464|OG000|Outcome|Placebo Vaginal Gel|"The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.~Placebo vaginal gel: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator."
11374570|NCT01959464|OG001|Outcome|Crinone Vaginal Progesterone Gel|"Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.~On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.~Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator."
11190778|NCT02128828|FG000|Participant Flow|Cenicriviroc|"cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily~cenicriviroc: cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc"
11240540|NCT02480153|EG002|Reported Event|Period 2: PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2. PF-06410293 40 mg was administered every other week by subcutaneous injection in both periods.
10850254|NCT00300885|FG001|Participant Flow|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
10850255|NCT00300885|OG000|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
10963961|NCT00875212|OG000|Outcome|Control|intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
10963962|NCT00875212|OG001|Outcome|Calcium Glycerophosphate|intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)
10963963|NCT00875212|OG002|Outcome|Fluoride|intervention of using a dentifrice with 1,500 ppm of fluoride
10963964|NCT00875212|OG003|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a dentifrice containing fluoride and calcium glycerophosphate
11374571|NCT01959464|EG000|Reported Event|Placebo Vaginal Gel|"The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.~Placebo vaginal gel: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator."
11374572|NCT01959464|EG001|Reported Event|Crinone Vaginal Progesterone Gel|"Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.~On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.~Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator."
11374573|NCT01921166|BG000|Baseline|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
11374574|NCT01921166|BG001|Baseline|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
11374575|NCT01921166|BG002|Baseline|Total|Total of all reporting groups
11374576|NCT01921166|FG000|Participant Flow|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
11374577|NCT01921166|FG001|Participant Flow|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
11374578|NCT01921166|OG000|Outcome|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
11374579|NCT01921166|OG001|Outcome|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
11374580|NCT01921166|EG000|Reported Event|Clomiphene Plus Gonadotropins|"clomiphene plus gonadotropins~clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction"
11374581|NCT01921166|EG001|Reported Event|Leuprolide Flare|"Leuprolide flare~Leuprolide flare: Leuprolide flare ovulation induction"
11374582|NCT01886963|BG000|Baseline|Control - Blinded Use of SPY Elite|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
11374583|NCT01886963|BG001|Baseline|SPY - Unblinded Use of SPY Elite|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
11374584|NCT01886963|BG002|Baseline|Total|Total of all reporting groups
11374585|NCT01886963|FG000|Participant Flow|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
11374586|NCT01886963|FG001|Participant Flow|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
11374587|NCT01886963|OG000|Outcome|Group A|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
11374588|NCT01886963|OG001|Outcome|Group B|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
11374589|NCT01886963|EG000|Reported Event|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
11374590|NCT01886963|EG001|Reported Event|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
11376858|NCT02343120|OG004|Outcome|Part 1 and Part 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376859|NCT02343120|EG000|Reported Event|Part 1: 40 mg QD|Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376860|NCT02343120|EG001|Reported Event|Part 1: 80 mg QD|Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376861|NCT02343120|EG002|Reported Event|Part 1: 160 mg QD|Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
11376862|NCT02343120|EG003|Reported Event|Part 1 and Part 2: 160 mg BID|Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11190779|NCT02128828|OG000|Outcome|Cenicriviroc|"cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily~cenicriviroc: cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc"
11190780|NCT02128828|EG000|Reported Event|Cenicriviroc|"cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily~cenicriviroc: cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc"
11190781|NCT02128867|BG000|Baseline|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
11190782|NCT02128867|BG001|Baseline|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
11190783|NCT02128867|BG002|Baseline|Bouncing|"bouncing . intervention to relax the infant~bouncing"
11190784|NCT02128867|BG003|Baseline|Total|Total of all reporting groups
11190785|NCT02128867|FG000|Participant Flow|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
11190786|NCT02128867|FG001|Participant Flow|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
11374591|NCT01802281|BG000|Baseline|UPHOLD|UPHOLD Procedure
11190787|NCT02128867|FG002|Participant Flow|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
11190788|NCT02128867|OG000|Outcome|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
11190789|NCT02128867|OG001|Outcome|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
11190790|NCT02128867|OG002|Outcome|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
11190791|NCT02128867|EG000|Reported Event|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
11190792|NCT02128867|EG001|Reported Event|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
11190793|NCT02128867|EG002|Reported Event|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
11190794|NCT02128919|BG000|Baseline|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190795|NCT02128919|BG001|Baseline|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
11240541|NCT02480153|EG003|Reported Event|Period 2: Adalimumab-EU/Adalimumab-EU|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and remained in the adalimumab-EU group in Period 2. Adalimumab-EU 40 mg was administered every other week by subcutaneous injection in both periods.
11374592|NCT01802281|BG001|Baseline|USLS|Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
11190796|NCT02128919|BG002|Baseline|Total|Total of all reporting groups
11240542|NCT02480153|EG004|Reported Event|Period 2: Adalimumab-EU/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 in Period 2. Study drug 40 mg was administered every other week by subcutaneous injection in both periods.
11374593|NCT01802281|BG002|Baseline|Total|Total of all reporting groups
11240543|NCT02480153|EG005|Reported Event|Period 3: PF-06410293/PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the PF-06410293 group in Period 1 and continued to receive PF-06410293 in Period 2 and Period 3. PF-06410293 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11240544|NCT02480153|EG006|Reported Event|Period 3: Adalimumab-EU/Adalimumab-EU/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1, remained in the adalimumab-EU group in Period 2 and received PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11240545|NCT02480153|EG007|Reported Event|Period 3: Adalimumab-EU/PF-06410293/PF-06410293|This reporting group refers to the participants who were randomized to the adalimumab-EU group in Period 1 and switched to PF-06410293 from Period 2 and continued on PF-06410293 in Period 3. Study drug 40 mg was administered every other week by subcutaneous injection in all 3 periods.
11374594|NCT01802281|FG000|Participant Flow|Hysteropexy|"Uphold® LITE~Uphold® LITE: The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg."
11190797|NCT02128919|FG000|Participant Flow|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190798|NCT02128919|FG001|Participant Flow|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190799|NCT02128919|OG000|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190800|NCT02128919|OG001|Outcome|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
11374595|NCT01802281|FG001|Participant Flow|Hysterectomy and USLS|"Vaginal hysterectomy and uterosacral ligament suspension (USLS)~Uterosacral ligament suspension: The USLS procedure used in this protocol is a modification of the technique described by Shull."
11374596|NCT01802281|OG000|Outcome|UPHOLD|UPHOLD Procedure
11374597|NCT01802281|OG001|Outcome|USLS|Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
11374598|NCT01802281|EG000|Reported Event|Hysterectomy|Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
11374599|NCT01802281|EG001|Reported Event|Hysteropexy|UPHOLD Procedure
10963965|NCT00875212|OG000|Outcome|Control|use of a placebo dentifrice (no fluoride and no CaGP). The volunteers were asked to use the placebo dentifrices for more one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
10963966|NCT00875212|OG001|Outcome|Calcium Glycerophosphate|intervention of using a CaGP dentifrice
10963967|NCT00875212|OG002|Outcome|Fluoride|intrvention of using a 1,500 ppm fluoridated dentifrice
11374600|NCT01774253|BG000|Baseline|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
11374601|NCT01774253|FG000|Participant Flow|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
11374602|NCT01774253|OG000|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
11374603|NCT01774253|EG000|Reported Event|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
11374604|NCT01666145|BG000|Baseline|Intraoperative Imaging|"Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.~Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement."
11374605|NCT01666145|FG000|Participant Flow|Intraoperative Imaging|"Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.~Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement."
11374606|NCT01666145|OG000|Outcome|Intraoperative Imaging|"Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.~Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement."
11374607|NCT01666145|EG000|Reported Event|Intraoperative Imaging|"Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.~Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement."
11374608|NCT01505608|BG000|Baseline|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374609|NCT01505608|BG001|Baseline|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374610|NCT01505608|BG002|Baseline|Total|Total of all reporting groups
11374611|NCT01505608|FG000|Participant Flow|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374612|NCT01505608|FG001|Participant Flow|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
10963968|NCT00875212|OG003|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a CaGP+Fluoride dentifrice
11374613|NCT01505608|OG000|Outcome|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374614|NCT01505608|OG001|Outcome|Arm A- TMZ + Irinotecan Only|Did not receive TPI 287
11374615|NCT01505608|OG000|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374616|NCT01505608|OG001|Outcome|Phase I Patients + Phase II Assigned Arm B- Tmz +I+ TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374617|NCT01505608|OG001|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374618|NCT01505608|EG000|Reported Event|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374619|NCT01505608|EG001|Reported Event|Phase II Arm A- Subjects That Did Not Receive TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
11374620|NCT01483820|BG000|Baseline|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
11240546|NCT02480166|BG000|Baseline|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11374621|NCT01483820|FG000|Participant Flow|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
11374622|NCT01483820|OG000|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
11374623|NCT01483820|EG000|Reported Event|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
11374624|NCT01355679|BG000|Baseline|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
11374625|NCT01355679|FG000|Participant Flow|Guided Therapy|"A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).~Guided Therapy: A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be"
11374626|NCT01355679|OG000|Outcome|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
11190801|NCT02128919|OG001|Outcome|Sham tDCS|"tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190802|NCT02128919|EG000|Reported Event|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days~tDCS: Transcranial Direct Current Stimulation"
11190803|NCT02128919|EG001|Reported Event|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days~tDCS: Transcranial Direct Current Stimulation"
10850256|NCT00300885|OG001|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
11240547|NCT02480166|BG001|Baseline|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11374627|NCT01355679|OG000|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
11374628|NCT01355679|EG000|Reported Event|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
11374629|NCT01227616|BG000|Baseline|Ferumoxytol|30 mg Fe/mL for IV injection
11374630|NCT01227616|BG001|Baseline|Iron Sucrose|20 mg Fe/mL for IV injection
11374631|NCT01227616|BG002|Baseline|Total|Total of all reporting groups
11374632|NCT01227616|FG000|Participant Flow|Ferumoxytol|30 mg Fe/mL for IV injection
11374633|NCT01227616|FG001|Participant Flow|Iron Sucrose|20 mg Fe/mL for IV injection
11374634|NCT01227616|OG000|Outcome|Ferumoxytol|30 mg Fe/mL for IV injection
11374635|NCT01227616|OG001|Outcome|Iron Sucrose|20 mg Fe/mL for IV injection
11374636|NCT01227616|EG000|Reported Event|Ferumoxytol|30 mg Fe/mL for IV injection
11374637|NCT01227616|EG001|Reported Event|Iron Sucrose|20 mg Fe/mL for IV injection
11374638|NCT01192698|BG000|Baseline|IV Interferon|"IV interferon oral ribavirin~Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
11374639|NCT01192698|BG001|Baseline|no Treatment|standard of care for liver transplant
11374640|NCT01192698|BG002|Baseline|Total|Total of all reporting groups
11374641|NCT01192698|FG000|Participant Flow|IV Interferon|"IV interferon oral ribavirin~IV interferon: IV interferon 5MU during anhepatic phase"
11374642|NCT01192698|FG001|Participant Flow|no Treatment|standard of care
11374643|NCT01192698|OG000|Outcome|IV Interferon|"IV interferon oral ribavirin~Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
11374644|NCT01192698|OG001|Outcome|no Treatment|standard of care for liver transplant
11374645|NCT01192698|EG000|Reported Event|IV Interferon|"IV interferon oral ribavirin~IV interferon: IV interferon 5MU during anhepatic phase"
11374646|NCT01192698|EG001|Reported Event|no Treatment|standard of care for liver transplant
11374647|NCT01166386|BG000|Baseline|First Steps Treatment Intervention|"A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants. Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice. The acronym FANCI refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.~FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components"
11374648|NCT01166386|BG001|Baseline|Standard Rehabilitation Care|"The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury. The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.~FANCI: Watching DVDs chosen by participants on various topics."
11374649|NCT01166386|BG002|Baseline|Total|Total of all reporting groups
11374650|NCT01166386|FG000|Participant Flow|First Steps Treatment Intervention|"A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants. Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice. The acronym FANCI refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.~FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components"
11374651|NCT01166386|FG001|Participant Flow|Standard Rehabilitation Care|"The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury. The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.~FANCI: Watching DVDs chosen by participants on various topics."
11374652|NCT01166386|OG000|Outcome|First Steps Treatment Intervention|"A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants. Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice. The acronym FANCI refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.~FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components"
11374653|NCT01166386|OG001|Outcome|Standard Rehabilitation Care|"The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury. The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.~FANCI: Watching DVDs chosen by participants on various topics."
11240548|NCT02480166|BG002|Baseline|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
11240549|NCT02480166|BG003|Baseline|Total|Total of all reporting groups
11374654|NCT01166386|EG000|Reported Event|First Steps Treatment Intervention|"A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants. Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice. The acronym FANCI refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.~FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components"
11374655|NCT01166386|EG001|Reported Event|Standard Rehabilitation Care|"The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury. The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.~FANCI: Watching DVDs chosen by participants on various topics."
11374656|NCT01114217|BG000|Baseline|Received Ferumoxytol in IDA-303|Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
11374657|NCT01114217|BG001|Baseline|Did Not Receive Ferumoxytol in IDA-303|Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139] and did not receive ferumoxytol during AMAG-FER-IDA-303.
11374658|NCT01114217|BG002|Baseline|Total|Total of all reporting groups
11374659|NCT01114217|FG000|Participant Flow|Received Ferumoxytol in IDA-303|Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent iron deficiency anemia (IDA), defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).
11374660|NCT01114217|FG001|Participant Flow|Did Not Receive Ferumoxytol in IDA-303|Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139] and did not receive ferumoxytol during AMAG-FER-IDA-303.
11374661|NCT01114217|OG000|Outcome|Ferumoxytol|Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
11374662|NCT01114217|EG000|Reported Event|Received Ferumoxytol|Participants received ferumoxytol during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
11374663|NCT01114204|BG000|Baseline|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374664|NCT01114204|BG001|Baseline|Iron Sucrose|Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
11374665|NCT01114204|BG002|Baseline|Total|Total of all reporting groups
11374666|NCT01114204|FG000|Participant Flow|Ferumoxytol|Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374667|NCT01114204|FG001|Participant Flow|Iron Sucrose|Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
11374668|NCT01114204|OG000|Outcome|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374669|NCT01114204|OG001|Outcome|Iron Sucrose|Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
11374670|NCT01114204|EG000|Reported Event|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374671|NCT01114204|EG001|Reported Event|Iron Sucrose|Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
11374672|NCT01114139|BG000|Baseline|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374673|NCT01114139|BG001|Baseline|Placebo|Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
11374674|NCT01114139|BG002|Baseline|Total|Total of all reporting groups
11374675|NCT01114139|FG000|Participant Flow|Ferumoxytol|Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374676|NCT01114139|FG001|Participant Flow|Placebo|Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
11374677|NCT01114139|OG000|Outcome|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374678|NCT01114139|OG001|Outcome|Placebo|Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
11374679|NCT01114139|EG000|Reported Event|Ferumoxytol|Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
11374680|NCT01114139|EG001|Reported Event|Placebo|Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
11374681|NCT01059071|BG000|Baseline|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374682|NCT01059071|FG000|Participant Flow|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374683|NCT01059071|FG001|Participant Flow|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374684|NCT01059071|FG002|Participant Flow|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374685|NCT01059071|FG003|Participant Flow|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374686|NCT01059071|OG000|Outcome|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
10850257|NCT00300885|EG000|Reported Event|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
11374687|NCT01059071|OG001|Outcome|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374688|NCT01059071|OG002|Outcome|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374689|NCT01059071|OG003|Outcome|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374690|NCT01059071|OG000|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11240550|NCT02480166|FG000|Participant Flow|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11190804|NCT02128932|BG000|Baseline|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11191776|NCT02133742|EG000|Reported Event|Axitinib 5 mg + Pembrolizumab (MK-3475) 2 mg|Participants with no prior systemic treatment for advance cancer, received axitinib 5 mg twice daily orally in combination with pembrolizumab (MK-3475) 2 mg/kg of body weight intravenous infusion every 3 weeks up to a maximum of 6 months in dose finding phase (each cycle of 21 days). Participants received axitinib up to a maximum of 64 cycles and pembrolizumab up to 56 cycles in dose expansion phase (each cycle of 21 days) until documented disease progression or unacceptable toxicity or study discontinuation criteria were met.
10849890|NCT00299130|BG002|Baseline|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11191777|NCT02133781|BG000|Baseline|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
11191778|NCT02133781|BG001|Baseline|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11191779|NCT02133781|BG002|Baseline|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11191780|NCT02133781|BG003|Baseline|Total|Total of all reporting groups
11191781|NCT02133781|FG000|Participant Flow|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
10849891|NCT00299130|BG003|Baseline|Total|Total of all reporting groups
11191782|NCT02133781|FG001|Participant Flow|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
10849993|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11191783|NCT02133781|FG002|Participant Flow|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11374691|NCT01059071|EG000|Reported Event|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
11374692|NCT01027702|BG000|Baseline|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
11374693|NCT01027702|FG000|Participant Flow|MMRD: 3 x 10^4/kg DLI + MTX to Day +24|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
11374694|NCT01027702|FG001|Participant Flow|MMRD: 3 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374695|NCT01027702|FG002|Participant Flow|MMRD: 4 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374696|NCT01027702|FG003|Participant Flow|MMRD: 4 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
11374697|NCT01027702|FG004|Participant Flow|MMRD: 5 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
11374698|NCT01027702|FG005|Participant Flow|MUD: 3 x 10^4/kg DLI + MTX to Day +24|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
11374699|NCT01027702|FG006|Participant Flow|MUD: 3 x 10^4/kg DLI + MTX to Day +52|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374700|NCT01027702|OG000|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +24|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
11374701|NCT01027702|OG001|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374702|NCT01027702|OG002|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374703|NCT01027702|OG003|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
11374704|NCT01027702|OG004|Outcome|MMRD: 5 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
11374705|NCT01027702|OG005|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +24|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
11374706|NCT01027702|OG006|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +52|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
11374707|NCT01027702|OG000|Outcome|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
11191784|NCT02133781|OG000|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
11191785|NCT02133781|OG001|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11191786|NCT02133781|OG002|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11374708|NCT01027702|EG000|Reported Event|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
11374709|NCT00991887|BG000|Baseline|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
11374710|NCT00991887|BG001|Baseline|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
11374711|NCT00991887|BG002|Baseline|Total|Total of all reporting groups
11374712|NCT00991887|FG000|Participant Flow|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
10847192|NCT00282243|FG000|Participant Flow|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
11191787|NCT02133781|EG000|Reported Event|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
11191788|NCT02133781|EG001|Reported Event|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11374713|NCT00991887|FG001|Participant Flow|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
11374714|NCT00991887|OG000|Outcome|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
11374715|NCT00991887|OG001|Outcome|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
11374716|NCT00991887|EG000|Reported Event|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
11374717|NCT00991887|EG001|Reported Event|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
11374718|NCT00968864|BG000|Baseline|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
11374719|NCT00968864|FG000|Participant Flow|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
11374720|NCT00968864|OG000|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
11374721|NCT00968864|OG000|Outcome|Mismatched Related Donor Cohort|
11374722|NCT00968864|OG001|Outcome|Matched Unrelated Donor Cohort|
11374723|NCT00968864|OG000|Outcome|Mismatched Related Donor Cohort: Malignant Disease|Number of recipients alive following bone marrow transplant for malignant disease.
11374724|NCT00968864|OG001|Outcome|Mismatched Related Donor: Non-malignant Disease|Number of recipients alive following bone marrow transplant for non-malignant disease.
11374725|NCT00968864|OG002|Outcome|Matched Unrelated Donor Cohort|Number of recipients alive following bone marrow transplant for non-malignant disease.
11374726|NCT00968864|EG000|Reported Event|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
11374727|NCT00934700|BG000|Baseline|Combination of Hypothermia and Xenon|Combination of whole body cooling to 33.5 rectal and 30% Xenon gas inhaled for 24 hours
11374728|NCT00934700|BG001|Baseline|Hypothermia and Standard Intensive Care|72 hours of whole body cooling to 33.5 rectal and standard intensive care
11374729|NCT00934700|BG002|Baseline|Total|Total of all reporting groups
11374730|NCT00934700|FG000|Participant Flow|Combination of Hypothermia and Xenon|Combination of 72 hours of whole body cooling to 33.5 rectal and 30% Xenon gas inhaled for 24 hours
11374731|NCT00934700|FG001|Participant Flow|Hypothermia and Standard Intensive Care|72 hours of whole body cooling to 33.5 rectal and standard intensive care
11374732|NCT00934700|OG000|Outcome|Combination of Hypothermia and Xenon|Combination of whole body cooling to 33.5 rectal and hypothermia and 30% Xenon gas inhaled for 24 hours
11374733|NCT00934700|OG001|Outcome|Hypothermia and Standard Intensive Care|72 hours of whole body cooling to 33.5 rectal and standard intensive care
11374734|NCT00934700|OG000|Outcome|Combination of Hypothermia and Xenon|Combination of 72 hours of whole body cooling to 33.5 rectal and 30% Xenon gas inhaled for 24 hours
11374735|NCT00934700|EG000|Reported Event|Combination of Hypothermia and Xenon|Combination of whole body cooling to 33.5 rectal and 30% Xenon gas inhaled for 24 hours
11374736|NCT00934700|EG001|Reported Event|Hypothermia and Standard Intensive Care|72 hours of whole body cooling to 33.5 rectal and standard intensive care
11374737|NCT00867568|BG000|Baseline|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
11374738|NCT00867568|FG000|Participant Flow|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
11374739|NCT00867568|OG000|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
11374740|NCT00867568|EG000|Reported Event|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
11374741|NCT00785291|BG000|Baseline|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374742|NCT00785291|BG001|Baseline|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374743|NCT00785291|BG002|Baseline|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
11374744|NCT00785291|BG003|Baseline|Total|Total of all reporting groups
11374745|NCT00785291|FG000|Participant Flow|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374746|NCT00785291|FG001|Participant Flow|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374747|NCT00785291|FG002|Participant Flow|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
11374748|NCT00785291|OG000|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374749|NCT00785291|OG001|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374750|NCT00785291|OG002|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
11374751|NCT00785291|EG000|Reported Event|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374752|NCT00785291|EG001|Reported Event|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
11374753|NCT00785291|EG002|Reported Event|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
11374754|NCT00782288|BG000|Baseline|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
11374755|NCT00782288|BG001|Baseline|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
11374756|NCT00782288|BG002|Baseline|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
11374757|NCT00782288|BG003|Baseline|Total|Total of all reporting groups
11374758|NCT00782288|FG000|Participant Flow|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
11374759|NCT00782288|FG001|Participant Flow|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
11374760|NCT00782288|FG002|Participant Flow|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
11374761|NCT00782288|OG000|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
11374762|NCT00782288|OG001|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
11374763|NCT00782288|OG002|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
11374764|NCT00782288|OG001|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
11374765|NCT00782288|OG000|Outcome|All Participants|All study participants had nasal cells collected pre and post treatment during the study. Because the data set is extremely large, the full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) this information can be obtained under the accession number.
11374766|NCT00782288|EG000|Reported Event|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
11374767|NCT00782288|EG001|Reported Event|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
11191789|NCT02133781|EG002|Reported Event|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
11190805|NCT02128932|BG001|Baseline|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11191790|NCT02134015|BG000|Baseline|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
11191791|NCT02134015|BG001|Baseline|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
11190806|NCT02128932|BG002|Baseline|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
11190807|NCT02128932|BG003|Baseline|Total|Total of all reporting groups
11190808|NCT02128932|FG000|Participant Flow|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11191792|NCT02134015|BG002|Baseline|Total|Total of all reporting groups
11191793|NCT02134015|FG000|Participant Flow|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
11190809|NCT02128932|FG001|Participant Flow|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11190810|NCT02128932|FG002|Participant Flow|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
11190811|NCT02128932|OG000|Outcome|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11374768|NCT00782288|EG002|Reported Event|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
11374782|NCT00643864|BG000|Baseline|Mirror Training|Training will be performed one hour a day, five days a week, Monday through friday, for four weeks.
11374783|NCT00643864|FG000|Participant Flow|Mirror Training|Training will be performed one hour a day, five days per week, Monday through Friday, for four weeks.
11374784|NCT00643864|OG000|Outcome|Mirror Training|one group pre post design
11374785|NCT00643864|OG000|Outcome|Mirror Training|"Training will be performed one-on-one by an investigator in a quiet room, one hour a day, five days a week, for four weeks. The mirror-box apparatus consists of an 18 x 24 vertical mirror secured in the center of a wooden platform. During training, the mirror-box will be placed on a table in front of the subject so that the mirror is perpendicular to the chest, slightly lateral of midline. Subjects will be asked to attend to the mirror reflection of their unaffected hand performing a series of tasks, while keeping their affected limb still. At the end of the four week training period, posttests will be administered by the same therapist who performed the pretests."
11374786|NCT00643864|EG000|Reported Event|Mirror Training|Training will be performed one hour a day, five days per week, Monday through Friday, for four weeks.
11374787|NCT00628446|BG000|Baseline|Study Group|
11374788|NCT00628446|FG000|Participant Flow|Study Group|
11374789|NCT00628446|OG000|Outcome|Study Group|Cross-sectional study group
11374790|NCT00628446|OG000|Outcome|Group 1|
11374791|NCT00628446|EG000|Reported Event|Study Group|
11374792|NCT00621751|BG000|Baseline|Carbamazepine|"Carbamazepine 800 mg daily~Carbamazepine: 800 mg daily"
11374793|NCT00621751|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11374794|NCT00621751|BG002|Baseline|Total|Total of all reporting groups
11374795|NCT00621751|FG000|Participant Flow|Carbamazepine|"Carbamazepine 800 mg daily~Carbamazepine: 800 mg daily"
11374796|NCT00621751|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11374797|NCT00621751|OG000|Outcome|Carbamazepine|"Carbamazepine 800 mg daily~Carbamazepine: 800 mg daily"
11374798|NCT00621751|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11374799|NCT00621751|EG000|Reported Event|Carbamazepine|"Carbamazepine 800 mg daily~Carbamazepine: 800 mg daily"
11374800|NCT00621751|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11374801|NCT00605215|BG000|Baseline|Placebo|Participants received 1 capsule of placebo matched to laquinimod orally once daily for 24 months.
11374802|NCT00605215|BG001|Baseline|Laquinimod|Participants received 1 capsule of laquinimod 0.6 mg orally once daily for 24 months.
11374803|NCT00605215|BG002|Baseline|Avonex®|Participants received an injection of Avonex® 30 mcg given IM once weekly for 24 months.
11374804|NCT00605215|BG003|Baseline|Total|Total of all reporting groups
11374805|NCT00605215|FG000|Participant Flow|Placebo|Participants received 1 capsule of placebo matched to laquinimod orally once daily for 24 months.
11374806|NCT00605215|FG001|Participant Flow|Laquinimod|Participants received 1 capsule of laquinimod 0.6 millograms (mg) orally once daily for 24 months.
11374807|NCT00605215|FG002|Participant Flow|Avonex®|Participants received an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months.
11374808|NCT00605215|OG000|Outcome|Placebo|Participants received 1 capsule of placebo matched to laquinimod orally once daily for 24 months.
11374809|NCT00605215|OG001|Outcome|Laquinimod|Participants received 1 capsule of laquinimod 0.6 mg orally once daily for 24 months.
11374810|NCT00605215|OG002|Outcome|Avonex®|Participants received an injection of Avonex® 30 mcg given IM once weekly for 24 months.
11374811|NCT00605215|EG000|Reported Event|Placebo|Participants received 1 capsule of placebo matched to laquinimod orally once daily for 24 months.
11374812|NCT00605215|EG001|Reported Event|Laquinimod|Participants received 1 capsule of laquinimod 0.6 mg orally once daily for 24 months.
11374813|NCT00605215|EG002|Reported Event|Avonex®|Participants received an injection of Avonex® 30 mcg given IM once weekly for 24 months.
11374814|NCT00605150|BG000|Baseline|TheraSphere Treatment|Total number of patients enrolled, TheraSphere treatment
11374815|NCT00605150|FG000|Participant Flow|Treatment|TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable hepatocellular carcinoma (HCC)
11191794|NCT02134015|FG001|Participant Flow|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
11191795|NCT02134015|OG000|Outcome|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
11374816|NCT00605150|OG000|Outcome|TheraSphere Treatment|Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
11374817|NCT00605150|EG000|Reported Event|TheraSphere Treatment for Patients With Unresectable HCC|Total number of patients enrolled, TheraSphere treatment for patients with unresectable HCC
11374818|NCT00552513|BG000|Baseline|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
11374819|NCT00552513|BG001|Baseline|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
11374820|NCT00552513|BG002|Baseline|Total|Total of all reporting groups
11374821|NCT00552513|FG000|Participant Flow|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
11374822|NCT00552513|FG001|Participant Flow|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
11374823|NCT00552513|OG000|Outcome|Early Intervention|Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
11374824|NCT00552513|OG001|Outcome|Delayed Intervention|Coronary angiography to be performed after a minimum delay of 36 hours after randomization
11374825|NCT00552513|OG000|Outcome|Early Intervention|
11374826|NCT00552513|OG001|Outcome|Delayed Intervention|
11374827|NCT00552513|EG000|Reported Event|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
11374828|NCT00552513|EG001|Reported Event|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
11374829|NCT00368836|BG000|Baseline|Phase II|Symptomatic population undergoing testing for pulmonary embolism. Blood samples were used to obtain D-dimer levels and breath samples were used to generate the BreathScreen PE CO2/O2 ratio.
11374830|NCT00368836|BG001|Baseline|Phase I|Pre-op/Post op subjects undergoing surgery. Blood and breath samples were collected before and after surgery. Blood samples were used to obtain D-dimer levels and breath samples were used to generate the BreathScreen PE CO2/O2 ratio.
11374831|NCT00368836|BG002|Baseline|Total|Total of all reporting groups
11374832|NCT00368836|FG000|Participant Flow|BreathScreen PE|BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery
11374833|NCT00368836|OG000|Outcome|BreathScreen PE|BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery
11374834|NCT00368836|OG000|Outcome|CO2/O2 Plus D-dimer|Probability of pulmonary embolism diagnosis by CO2/O2 collected with the BreathScreen PE plus D-dimer measurement as compared to D-dimer alone. D-dimer > 499 ng/ml, etCO2/O2 < 0.28, Pulmonary Embolism diagnosed by CT scan
11374835|NCT00368836|OG001|Outcome|D-dimer|Probability of pulmonary embolism diagnosis by D-dimer alone as compared to D-dimer plus CO2/O2 measured with the BreathScren PE. D-dimer > 499 ng/ml, etCO2/O2 < 0.28, Pulmonary Embolism diagnosed by CT scan
11374836|NCT00368836|EG000|Reported Event|Phase II|Phase II: symptomatic subjects undergoing testing for PE
11374837|NCT00368836|EG001|Reported Event|Phase I|Pre-op/Post op: subjects undergoing surgery
11374838|NCT00290511|BG000|Baseline|R-FIND + Zevalin|Fludarabine 25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
11374839|NCT00290511|FG000|Participant Flow|R-FIND + Zevalin|Fludarabine 25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
11374840|NCT00290511|OG000|Outcome|R-FIND + Zevalin|Fludarabine 25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
11374841|NCT00290511|EG000|Reported Event|R-FIND + Zevalin|Fludarabine 25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.
11374842|NCT00265798|BG000|Baseline|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11374843|NCT00265798|FG000|Participant Flow|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11374844|NCT00265798|OG000|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11374845|NCT00265798|EG000|Reported Event|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11376863|NCT02343120|EG004|Reported Event|Part 1 and Part 2: 320 mg QD|Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
11376864|NCT02066415|BG000|Baseline|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376865|NCT02066415|BG001|Baseline|Erenumab 70 mg|Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376866|NCT02066415|BG002|Baseline|Erenumab 140 mg|Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376867|NCT02066415|BG003|Baseline|Total|Total of all reporting groups
11376868|NCT02066415|FG000|Participant Flow|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376869|NCT02066415|FG001|Participant Flow|Erenumab 70 mg|Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376870|NCT02066415|FG002|Participant Flow|Erenumab 140 mg|Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376871|NCT02066415|OG000|Outcome|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376872|NCT02066415|OG001|Outcome|Erenumab 70 mg|Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376873|NCT02066415|OG002|Outcome|Erenumab 140 mg|Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376874|NCT02066415|EG000|Reported Event|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376875|NCT02066415|EG001|Reported Event|Erenumab 70 mg|Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376876|NCT02066415|EG002|Reported Event|Erenumab 140 mg|Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
11376877|NCT01952574|BG000|Baseline|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376878|NCT01952574|BG001|Baseline|Erenumab 7 mg QM|Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376879|NCT01952574|BG002|Baseline|Erenumab 21 mg QM|Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376880|NCT01952574|BG003|Baseline|Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376881|NCT01952574|BG004|Baseline|Total|Total of all reporting groups
11376882|NCT01952574|FG000|Participant Flow|DBTP: Placebo QM|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376883|NCT01952574|FG001|Participant Flow|DBTP: Erenumab 7 mg QM|Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376884|NCT01952574|FG002|Participant Flow|DBTP: Erenumab 21 mg QM|Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376885|NCT01952574|FG003|Participant Flow|DBTP: Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11191796|NCT02134015|OG001|Outcome|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
11191797|NCT02134015|EG000|Reported Event|Placebo + Erlotinib|Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
11374846|NCT00641537|BG000|Baseline|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
11374847|NCT00641537|BG001|Baseline|Cladribine High Dose/Placebo (HLPP)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374848|NCT00641537|BG002|Baseline|Cladribine Low/Low Dose (LLLL)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374849|NCT00641537|BG003|Baseline|Cladribine High/Low Dose (HLLL)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374850|NCT00641537|BG004|Baseline|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374851|NCT00641537|BG005|Baseline|Total|Total of all reporting groups
11374852|NCT00641537|FG000|Participant Flow|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
11374853|NCT00641537|FG001|Participant Flow|Cladribine High Dose/Placebo (HLPP)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374854|NCT00641537|FG002|Participant Flow|Cladribine Low/Low Dose (LLLL)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374855|NCT00641537|FG003|Participant Flow|Cladribine High/Low Dose (HLLL)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374856|NCT00641537|FG004|Participant Flow|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374857|NCT00641537|FG005|Participant Flow|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374858|NCT00641537|FG006|Participant Flow|Cladribine 3.5 mg/kg/No Treatment|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374859|NCT00641537|FG007|Participant Flow|Cladribine 5.25 mg/kg/No Treatment|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374860|NCT00641537|OG000|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
11374861|NCT00641537|OG001|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374862|NCT00641537|OG002|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374863|NCT00641537|OG003|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11191798|NCT02134015|EG001|Reported Event|Patritumab + Erlotinib|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
11374864|NCT00641537|OG004|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374865|NCT00641537|OG000|Outcome|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374866|NCT00641537|OG001|Outcome|Cladribine 3.5 mg/kg/No Treatment|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374867|NCT00641537|OG002|Outcome|Cladribine 5.25 mg/kg/No Treatment|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374868|NCT00641537|EG000|Reported Event|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
11374869|NCT00641537|EG001|Reported Event|Cladribine High Dose/Placebo (HLPP)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374870|NCT00641537|EG002|Reported Event|Cladribine Low/Low Dose (LLLL)|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374871|NCT00641537|EG003|Reported Event|Cladribine High/Low Dose (HLLL)|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374872|NCT00641537|EG004|Reported Event|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
11374873|NCT00641537|EG005|Reported Event|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374874|NCT00641537|EG006|Reported Event|Cladribine 3.5 mg/kg/No Treatment|Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11374875|NCT00641537|EG007|Reported Event|Cladribine 5.25 mg/kg/No Treatment|Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
11376886|NCT01952574|FG004|Participant Flow|OLTP: Erenumab 70/140 mg QM|Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376887|NCT01952574|FG005|Participant Flow|CHU Substudy: Erenumab 140 mg by Prefilled Syringe|Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376888|NCT01952574|FG006|Participant Flow|CHU Substudy: Erenumab 140 mg Autoinjector/Pen|Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector (AI)/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376889|NCT01952574|OG000|Outcome|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376890|NCT01952574|OG001|Outcome|Erenumab 7 mg QM|Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376891|NCT01952574|OG002|Outcome|Erenumab 21 mg QM|Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376892|NCT01952574|OG003|Outcome|Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376893|NCT01952574|OG000|Outcome|CHU Substudy: Erenumab 140 mg Prefilled Syringe|Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
10849892|NCT00299130|FG000|Participant Flow|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10850258|NCT00300885|EG001|Reported Event|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
11374880|NCT00663052|BG000|Baseline|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
11374881|NCT00663052|BG001|Baseline|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
11191799|NCT02134119|BG000|Baseline|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
11374882|NCT00663052|BG002|Baseline|Total|Total of all reporting groups
11190812|NCT02128932|OG001|Outcome|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11374876|NCT00655824|BG000|Baseline|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
11374877|NCT00655824|FG000|Participant Flow|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
11374878|NCT00655824|OG000|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
11374879|NCT00655824|EG000|Reported Event|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
11374883|NCT00663052|FG000|Participant Flow|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
11374884|NCT00663052|FG001|Participant Flow|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
11190813|NCT02128932|OG002|Outcome|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
11190814|NCT02128932|EG000|Reported Event|Semaglutide 0.5mg/Week|Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
11190815|NCT02128932|EG001|Reported Event|Semaglutide 1.0 mg/Week|Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
10850259|NCT00301028|BG000|Baseline|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
11190816|NCT02128932|EG002|Reported Event|Insulin Glargine|Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
11190817|NCT02128997|BG000|Baseline|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
11190818|NCT02128997|BG001|Baseline|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
11190819|NCT02128997|BG002|Baseline|Total|Total of all reporting groups
10847193|NCT00282243|OG000|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
10850260|NCT00301028|FG000|Participant Flow|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
10850261|NCT00301028|OG000|Outcome|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
10850262|NCT00301028|EG000|Reported Event|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
11191800|NCT02134119|BG001|Baseline|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
11190820|NCT02128997|FG000|Participant Flow|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
11190821|NCT02128997|FG001|Participant Flow|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
11190822|NCT02128997|OG000|Outcome|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
11190823|NCT02128997|OG001|Outcome|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
11190824|NCT02128997|EG000|Reported Event|Closed Incision Wound Vacuum (Prevena)|"Closed incision wound vacuum (Prevena)~Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision"
11190825|NCT02128997|EG001|Reported Event|Routine Wound Care|This arm includes patients having a cesarean section with routine wound care
11190826|NCT02129062|BG000|Baseline|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
11190827|NCT02129062|FG000|Participant Flow|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
11190828|NCT02129062|OG000|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
11190829|NCT02129062|EG000|Reported Event|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
11190830|NCT02129075|BG000|Baseline|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant Flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11190831|NCT02129075|BG001|Baseline|Arm II (CDX-1401 and Poly-ICLC)|"Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401and poly-ICLC as in Arm I. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies"
11190832|NCT02129075|BG002|Baseline|Total|Total of all reporting groups
11190833|NCT02129075|FG000|Participant Flow|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11190834|NCT02129075|FG001|Participant Flow|Arm II (CDX-1401 and Poly-ICLC)|"Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401and poly-ICLC as in Arm I. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies"
11191801|NCT02134119|BG002|Baseline|Total|Total of all reporting groups
10847194|NCT00282243|EG000|Reported Event|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
11191802|NCT02134119|FG000|Participant Flow|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
11190835|NCT02129075|OG000|Outcome|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant Flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11190836|NCT02129075|OG001|Outcome|Arm II (CDX-1401 and Poly-ICLC)|"Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401and poly-ICLC as in Arm I. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies"
11190837|NCT02129075|OG000|Outcome|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant flt3 ligand SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11190838|NCT02129075|OG000|Outcome|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11191803|NCT02134119|FG001|Participant Flow|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
11190839|NCT02129075|EG000|Reported Event|Arm I (CDX-301, CDX-1401, and Poly-ICLC)|"Patients receive recombinant Flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC"
11190840|NCT02129075|EG001|Reported Event|Arm II (CDX-1401 and Poly-ICLC)|"Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401and poly-ICLC as in Arm I. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies"
11191804|NCT02134119|OG000|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
11191805|NCT02134119|OG001|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
11190841|NCT02129192|BG000|Baseline|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
11190842|NCT02129192|BG001|Baseline|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
11190843|NCT02129192|BG002|Baseline|Total|Total of all reporting groups
11191806|NCT02134119|EG000|Reported Event|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
11191807|NCT02134119|EG001|Reported Event|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
11190844|NCT02129192|FG000|Participant Flow|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
11190845|NCT02129192|FG001|Participant Flow|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
11190846|NCT02129192|OG000|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
11190847|NCT02129192|OG001|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
11374885|NCT00663052|OG000|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
11190848|NCT02129192|OG000|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
11190849|NCT02129192|OG001|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
11190850|NCT02129192|EG000|Reported Event|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
11190851|NCT02129192|EG001|Reported Event|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
11190852|NCT02129192|EG002|Reported Event|Total.|All participants randomised into the study.
11190853|NCT02129205|BG000|Baseline|PF-06650808 0.2 mg/kg (Part 1)|PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190854|NCT02129205|BG001|Baseline|PF-06650808 0.4 mg/kg (Part 1)|PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190855|NCT02129205|BG002|Baseline|PF-06650808 0.8 mg/kg (Part 1)|PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190856|NCT02129205|BG003|Baseline|PF-06650808 1.6 mg/kg (Part 1)|PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190857|NCT02129205|BG004|Baseline|PF-06650808 2.0 mg/kg (Part 1)|PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190858|NCT02129205|BG005|Baseline|PF-06650808 2.4 mg/kg (Part 1)|PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190859|NCT02129205|BG006|Baseline|PF-06650808 3.0 mg/kg (Part 1)|PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11374886|NCT00663052|OG001|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
10962899|NCT00869050|BG000|Baseline|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
10962900|NCT00869050|FG000|Participant Flow|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
10962901|NCT00869050|OG000|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
10962902|NCT00869050|EG000|Reported Event|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
10962903|NCT00869089|BG000|Baseline|CC-10004|CC-10004 Treatment
10962904|NCT00869089|FG000|Participant Flow|CC-10004|"CC-10004 treatment:~30mg,oral medication, BID, for 24 weeks (60mg total DAILY)"
10962905|NCT00869089|OG000|Outcome|CC-10004|CC-10004 treatment
10962906|NCT00869089|EG000|Reported Event|CC-10004|CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
10962907|NCT00869141|BG000|Baseline|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962908|NCT00869141|BG001|Baseline|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962909|NCT00869141|BG002|Baseline|Total|Total of all reporting groups
10962910|NCT00869141|FG000|Participant Flow|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962911|NCT00869141|FG001|Participant Flow|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962912|NCT00869141|OG000|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962913|NCT00869141|OG001|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962914|NCT00869141|OG000|Outcome|Hypertensive Phase Group|Eyes that developed hypertensive phase after Ahmed valve implantation
10962915|NCT00869141|OG001|Outcome|Non-hypertensive Phase Group|Eyes that did not develop hypertensive phase after Ahmed valve implantation
10962916|NCT00869141|EG000|Reported Event|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962917|NCT00869141|EG001|Reported Event|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
10962918|NCT00869167|BG000|Baseline|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
10962919|NCT00869167|BG001|Baseline|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
10962920|NCT00869167|BG002|Baseline|Total|Total of all reporting groups
10962921|NCT00869167|FG000|Participant Flow|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
10962922|NCT00869167|FG001|Participant Flow|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
10962923|NCT00869167|OG000|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
11190860|NCT02129205|BG007|Baseline|PF-06650808 3.6 mg/kg (Part 1)|PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
10962924|NCT00869167|OG001|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
11190861|NCT02129205|BG008|Baseline|PF-06650808 4.68 mg/kg (Part 1)|PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190862|NCT02129205|BG009|Baseline|PF-06650808 2.4 mg/kg (Part 2)|Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
11190863|NCT02129205|BG010|Baseline|Total|Total of all reporting groups
11190864|NCT02129205|FG000|Participant Flow|PF-06650808 0.2 mg/kg (Part 1)|PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
10962925|NCT00869167|OG000|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
11190865|NCT02129205|FG001|Participant Flow|PF-06650808 0.4 mg/kg (Part 1)|PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190866|NCT02129205|FG002|Participant Flow|PF-06650808 0.8 mg/kg (Part 1)|PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190867|NCT02129205|FG003|Participant Flow|PF-06650808 1.6 mg/kg (Part 1)|PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190868|NCT02129205|FG004|Participant Flow|PF-06650808 2.0 mg/kg (Part 1)|PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190869|NCT02129205|FG005|Participant Flow|PF-06650808 2.4 mg/kg (Part 1)|PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190870|NCT02129205|FG006|Participant Flow|PF-06650808 3.0 mg/kg (Part 1)|PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190871|NCT02129205|FG007|Participant Flow|PF-06650808 3.6 mg/kg (Part 1)|PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190872|NCT02129205|FG008|Participant Flow|PF-06650808 4.68 mg/kg (Part 1)|PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190873|NCT02129205|FG009|Participant Flow|PF-06650808 2.4mg/kg (Part 2)|Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
11190874|NCT02129205|OG000|Outcome|PF-06650808 0.2 mg/kg (Part 1)|PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190875|NCT02129205|OG001|Outcome|PF-06650808 0.4 mg/kg (Part 1)|PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190876|NCT02129205|OG002|Outcome|PF-06650808 0.8 mg/kg (Part 1)|PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190877|NCT02129205|OG003|Outcome|PF-06650808 1.6 mg/kg (Part 1)|PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190878|NCT02129205|OG004|Outcome|PF-06650808 2.0 mg/kg (Part 1)|PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190879|NCT02129205|OG005|Outcome|PF-06650808 2.4 mg/kg (Part 1)|PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190880|NCT02129205|OG006|Outcome|PF-06650808 3.0 mg/kg (Part 1)|PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190881|NCT02129205|OG007|Outcome|PF-06650808 3.6 mg/kg (Part 1)|PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190882|NCT02129205|OG008|Outcome|PF-06650808 4.68 mg/kg (Part 1)|PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190883|NCT02129205|OG009|Outcome|PF-06650808 2.4 mg/kg (Part 2)|Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
11374887|NCT00663052|EG000|Reported Event|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
11374888|NCT00663052|EG001|Reported Event|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
11190884|NCT02129205|OG001|Outcome|PF-06650808 0.8 mg/kg (Part 1)|PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190885|NCT02129205|OG002|Outcome|PF-06650808 0.4 mg/kg (Part 1)|PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
11190886|NCT02129205|OG000|Outcome|PF-06650808 2.4 mg/kg (Part 2)|Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
11190887|NCT02129205|EG000|Reported Event|PF-06650808 0.2 mg/kg|PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190888|NCT02129205|EG001|Reported Event|PF-06650808 0.4 mg/kg|PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190889|NCT02129205|EG002|Reported Event|PF-06650808 0.8 mg/kg|PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190890|NCT02129205|EG003|Reported Event|PF-06650808 1.6 mg/kg|PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190891|NCT02129205|EG004|Reported Event|PF-06650808 2.0 mg/kg|PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190892|NCT02129205|EG005|Reported Event|PF-06650808 2.4 mg/kg|PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190893|NCT02129205|EG006|Reported Event|PF-06650808 3.0 mg/kg|PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190894|NCT02129205|EG007|Reported Event|PF-06650808 3.6 mg/kg|PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190895|NCT02129205|EG008|Reported Event|PF-06650808 4.68 mg/kg|PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
11190896|NCT02129426|BG000|Baseline|Dexmedetomidine and Ketamine|"Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.~Ketamine~Dexmedetomidine"
11190897|NCT02129426|BG001|Baseline|Dexmedetomidine and Midazolam|"Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.~Midazolam~Dexmedetomidine"
11190898|NCT02129426|BG002|Baseline|Total|Total of all reporting groups
11190899|NCT02129426|FG000|Participant Flow|Dexmedetomidine and Ketamine|"Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.~Ketamine~Dexmedetomidine"
11190900|NCT02129426|FG001|Participant Flow|Dexmedetomidine and Midazolam|"Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.~Midazolam~Dexmedetomidine"
11190901|NCT02129426|OG000|Outcome|Dexmedetomidine and Ketamine|"Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.~Ketamine~Dexmedetomidine"
11190902|NCT02129426|OG001|Outcome|Dexmedetomidine and Midazolam|"Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.~Midazolam~Dexmedetomidine"
11190903|NCT02129426|EG000|Reported Event|Dexmedetomidine and Ketamine|"Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.~Ketamine~Dexmedetomidine"
11190904|NCT02129426|EG001|Reported Event|Dexmedetomidine and Midazolam|"Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.~Midazolam~Dexmedetomidine"
11190905|NCT02129478|BG000|Baseline|Olanzapine|"Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.~Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg)."
11190906|NCT02129478|FG000|Participant Flow|Olanzapine|"Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.~Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg)."
11190907|NCT02129478|OG000|Outcome|Olanzapine|"Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.~Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg)."
11190908|NCT02129478|EG000|Reported Event|Olanzapine|"Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.~Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg)."
11191808|NCT02134184|BG000|Baseline|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
11191809|NCT02134184|BG001|Baseline|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
11191810|NCT02134184|BG002|Baseline|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
11191811|NCT02134184|BG003|Baseline|Total|Total of all reporting groups
10962926|NCT00869167|OG001|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
11190909|NCT02129556|BG000|Baseline|Phase Ib|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190910|NCT02129556|BG001|Baseline|Phase II PD-L1+|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190911|NCT02129556|BG002|Baseline|Phase II PD-L1-|HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190912|NCT02129556|BG003|Baseline|Total|Total of all reporting groups
11190913|NCT02129556|FG000|Participant Flow|Phase Ib 2 mg/kg|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. In the Phase Ib portion of the trial, two weight-based doses of MK-3475 were specified in the dose escalation (2 mg/kg and 10 mg/kg).
11374889|NCT00686374|BG000|Baseline|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
11240551|NCT02480166|FG001|Participant Flow|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11240552|NCT02480166|FG002|Participant Flow|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
10962927|NCT00869167|EG000|Reported Event|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
11190914|NCT02129556|FG001|Participant Flow|Phase Ib 10 mg/kg|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. In the Phase Ib portion of the trial, two weight-based doses of MK-3475 were specified in the dose escalation (2 mg/kg and 10 mg/kg).
11190915|NCT02129556|FG002|Participant Flow|Phase II PD-L1+|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. The Phase II portion of the trial used a flat dose of 200 mg of MK-3475 based on emerging data from the sponsor.
11190916|NCT02129556|FG003|Participant Flow|Phase II PD-L1-|HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. The Phase II portion of the trial used a flat dose of 200 mg of MK-3475 based on emerging data from the sponsor.
11190917|NCT02129556|OG000|Outcome|Phase Ib 2 mg/kg|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190918|NCT02129556|OG001|Outcome|Phase Ib 10 mg/kg|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190919|NCT02129556|OG000|Outcome|Phase Ib|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. All 6 patients in Phase Ib were combined when reporting clinical measures for secondary outcomes and adverse events, for stronger response rates.
11190920|NCT02129556|OG001|Outcome|Phase II PD-L1+|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11190921|NCT02129556|OG002|Outcome|Phase II PD-L1-|HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
11191812|NCT02134184|FG000|Participant Flow|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11190922|NCT02129556|EG000|Reported Event|Phase Ib|HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. All 6 patients in Phase I were combined when reporting clinical measures for secondary outcomes adverse events for stronger response rates.
11190923|NCT02129556|EG001|Reported Event|Phase II (PD-L1+ and PD-L1-)|HER2-positive, PD-L1 expressing or PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. For adverse events, Phase II cohorts were combined since PD-L1 status does not affect toxicity.
11190924|NCT02129608|BG000|Baseline|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
11190925|NCT02129608|BG001|Baseline|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11190926|NCT02129608|BG002|Baseline|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11190927|NCT02129608|BG003|Baseline|Total|Total of all reporting groups
11240553|NCT02480166|OG000|Outcome|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11240554|NCT02480166|OG001|Outcome|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11240555|NCT02480166|OG002|Outcome|Treatment Extension to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
11240556|NCT02480166|OG002|Outcome|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
11240557|NCT02480166|EG000|Reported Event|8 Weeks SOF/LED|"Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11240558|NCT02480166|EG001|Reported Event|12 Weeks SOF/LED|"Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.~12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."
11240559|NCT02480166|EG002|Reported Event|Extended Treatment to 12 Weeks SOF/LED|Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
11240560|NCT02480439|BG000|Baseline|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
11240561|NCT02480439|BG001|Baseline|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
11240562|NCT02480439|BG002|Baseline|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11240563|NCT02480439|BG003|Baseline|Total|Total of all reporting groups
11240564|NCT02480439|FG000|Participant Flow|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
11240565|NCT02480439|FG001|Participant Flow|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
11240566|NCT02480439|FG002|Participant Flow|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11240567|NCT02480439|OG000|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11240568|NCT02480439|OG001|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11240569|NCT02480439|OG002|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11240570|NCT02480439|EG000|Reported Event|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11240571|NCT02480439|EG001|Reported Event|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11240572|NCT02480439|EG002|Reported Event|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11240573|NCT02480582|BG000|Baseline|Overall Sample|Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack.
11240574|NCT02480582|FG000|Participant Flow|Almond, Then No Food, Then Cheese Savouries|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
11374890|NCT00686374|FG000|Participant Flow|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
11374891|NCT00686374|OG000|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
11374892|NCT00686374|EG000|Reported Event|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
11376894|NCT01952574|OG001|Outcome|CHY SubStudy: Erenumab 140 mg Autoinjector/Pen|Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376895|NCT01952574|OG000|Outcome|OLTP: Erenumab 70 mg QM|Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
11376896|NCT01952574|OG001|Outcome|OLTP: Erenumab 140 mg QM|After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
11376897|NCT01952574|OG002|Outcome|OLTP: Erenumab 70/140 mg QM|Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376898|NCT01952574|OG000|Outcome|Placebo / Erenumab 70/140 mg QM|Participants randomized to placebo in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376899|NCT01952574|OG001|Outcome|Erenumab 7 mg QM / Erenumab 70/140 mg QM|Participants randomized to erenumab 7 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376900|NCT01952574|OG002|Outcome|Erenumab 21 mg QM / Erenumab 70/140 mg QM|Participants randomized to erenumab 21 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376901|NCT01952574|OG003|Outcome|Erenumab 70 mg QM / Erenumab 70/140 mg QM|Participants randomized to erenumab 70 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376902|NCT01952574|EG000|Reported Event|DBTP: Placebo QM|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376903|NCT01952574|EG001|Reported Event|DBTP: Erenumab 7 mg QM|Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376904|NCT01952574|EG002|Reported Event|DBTP: Erenumab 21 mg QM|Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376905|NCT01952574|EG003|Reported Event|DBTP: Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11376906|NCT01952574|EG004|Reported Event|OLTP: Erenumab 70 mg QM|Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
11376907|NCT01952574|EG005|Reported Event|OLTP: Erenumab 140 mg QM|After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
11376908|NCT01952574|EG006|Reported Event|OLTP: Erenumab 70/140 mg QM|Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
11376909|NCT01952574|EG007|Reported Event|CHU Substudy: Erenumab 140 mg PFS|Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376910|NCT01952574|EG008|Reported Event|CHU Substudy: Erenumab 140 mg AI/Pen|Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376911|NCT01952574|EG009|Reported Event|CHU Substudy: Total|Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe or autoinjector/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
11376912|NCT01659151|BG000|Baseline|Combination Therapy|"Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).~High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.~ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).~Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.~Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."
11374893|NCT00698828|BG000|Baseline|Placebo|Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.
11374894|NCT00698828|BG001|Baseline|SUN11031 20 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.
11374895|NCT00698828|BG002|Baseline|SUN11031 40 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
11374896|NCT00698828|BG003|Baseline|Total|Total of all reporting groups
11374897|NCT00698828|FG000|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.
11374898|NCT00698828|FG001|Participant Flow|SUN11031 20 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.
11374899|NCT00698828|FG002|Participant Flow|SUN11031 40 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
11374900|NCT00698828|OG000|Outcome|Placebo|Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.
11374901|NCT00698828|OG001|Outcome|SUN11031 20 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.
11374902|NCT00698828|OG002|Outcome|SUN11031 40 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
11374903|NCT00698828|EG000|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.
11374904|NCT00698828|EG001|Reported Event|SUN11031 20 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.
11374905|NCT00698828|EG002|Reported Event|SUN11031 40 μg/kg|Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
11374906|NCT00712933|BG000|Baseline|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
11374907|NCT00712933|FG000|Participant Flow|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
11374908|NCT00712933|OG000|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
11374909|NCT00712933|OG000|Outcome|Participants With no Prednisone and Other Steroids at Baseline|Participants were not receiving prednisone and other steroids at Baseline.
11374910|NCT00712933|OG001|Outcome|Participants With Baseline Daily Dose of >0 to <=7.5 mg|Participants were receiving a daily dose of >0 to <=7.5 mg of prednisone and other steroids at Baseline.
11374911|NCT00712933|OG002|Outcome|Participants With Baseline Daily Dose of >7.5 to <=40 mg|Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline.
11374912|NCT00712933|OG003|Outcome|Participants With Baseline Daily Dose of >40 mg|Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline.
11374913|NCT00712933|EG000|Reported Event|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
11374927|NCT00725985|BG000|Baseline|Cladribine 5.25 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
11374914|NCT00715273|BG000|Baseline|1 - Single Therapy Group|"Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Placebo Niacin: Placebo niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374915|NCT00715273|BG001|Baseline|2 - Double Therapy Group|"Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374916|NCT00715273|BG002|Baseline|3 - Triple Therapy Group|"Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Colesevelam: 3.8 g of colesevelam each day"
11374917|NCT00715273|BG003|Baseline|Total|Total of all reporting groups
11374918|NCT00715273|FG000|Participant Flow|1 - Single Therapy Group|"Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Placebo Niacin: Placebo niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374919|NCT00715273|FG001|Participant Flow|2 - Double Therapy Group|"Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374920|NCT00715273|FG002|Participant Flow|3 - Triple Therapy Group|"Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Colesevelam: 3.8 g of colesevelam each day"
11374921|NCT00715273|OG000|Outcome|1 - Single Therapy Group|"Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Placebo Niacin: Placebo niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374922|NCT00715273|OG001|Outcome|2 - Double Therapy Group|"Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374923|NCT00715273|OG002|Outcome|3 - Triple Therapy Group|"Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Colesevelam: 3.8 g of colesevelam each day"
11374924|NCT00715273|EG000|Reported Event|1 - Single Therapy Group|"Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Placebo Niacin: Placebo niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374925|NCT00715273|EG001|Reported Event|2 - Double Therapy Group|"Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Placebo Colesevelam: Placebo colesevelam each day"
11374926|NCT00715273|EG002|Reported Event|3 - Triple Therapy Group|"Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group~Atorvastatin: 10 to 80 mg of atorvastatin each day~Niacin: 2000 mg of niacin each day~Colesevelam: 3.8 g of colesevelam each day"
11374928|NCT00725985|BG001|Baseline|Cladribine 3.5 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
11374929|NCT00725985|BG002|Baseline|Placebo|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
11374930|NCT00725985|BG003|Baseline|Total|Total of all reporting groups
11374931|NCT00725985|FG000|Participant Flow|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
11374932|NCT00725985|FG001|Participant Flow|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374933|NCT00725985|FG002|Participant Flow|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374934|NCT00725985|FG003|Participant Flow|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374935|NCT00725985|FG004|Participant Flow|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374936|NCT00725985|FG005|Participant Flow|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374937|NCT00725985|FG006|Participant Flow|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374938|NCT00725985|FG007|Participant Flow|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374939|NCT00725985|FG008|Participant Flow|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374940|NCT00725985|FG009|Participant Flow|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374941|NCT00725985|FG010|Participant Flow|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374942|NCT00725985|FG011|Participant Flow|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374943|NCT00725985|OG000|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
11374944|NCT00725985|OG001|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374945|NCT00725985|OG002|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374946|NCT00725985|OG000|Outcome|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374947|NCT00725985|OG001|Outcome|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374948|NCT00725985|OG002|Outcome|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374949|NCT00725985|OG000|Outcome|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374950|NCT00725985|OG001|Outcome|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374951|NCT00725985|OG002|Outcome|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374952|NCT00725985|OG000|Outcome|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374953|NCT00725985|OG001|Outcome|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374954|NCT00725985|OG002|Outcome|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374955|NCT00725985|EG000|Reported Event|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
11374956|NCT00725985|EG001|Reported Event|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374957|NCT00725985|EG002|Reported Event|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
11374958|NCT00725985|EG003|Reported Event|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374959|NCT00725985|EG004|Reported Event|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374960|NCT00725985|EG005|Reported Event|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
11374961|NCT00725985|EG006|Reported Event|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374962|NCT00725985|EG007|Reported Event|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374963|NCT00725985|EG008|Reported Event|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374964|NCT00725985|EG009|Reported Event|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374965|NCT00725985|EG010|Reported Event|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11374966|NCT00725985|EG011|Reported Event|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
11376913|NCT01659151|FG000|Participant Flow|Combination Therapy|"Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).~High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.~ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).~Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.~Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."
11377182|NCT03850444|FG001|Participant Flow|Chemotherapy (SOC Treatment)-China Extension|Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11374967|NCT04860258|BG000|Baseline|Chronic Kidney Disease|Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
11374968|NCT04860258|BG001|Baseline|COPD|Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
11374969|NCT04860258|BG002|Baseline|Obesity|Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
11374970|NCT04860258|BG003|Baseline|Chronic Cardiovascular Disease|Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
11374971|NCT04860258|BG004|Baseline|Chronic HIV Infection|Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
11374972|NCT04860258|BG005|Baseline|Type 2 Diabetes Mellitus|Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
11374973|NCT04860258|BG006|Baseline|Renal Transplant|Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
11374974|NCT04860258|BG007|Baseline|Total|Total of all reporting groups
11374975|NCT04860258|FG000|Participant Flow|Chronic Kidney Disease|Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
11374976|NCT04860258|FG001|Participant Flow|Chronic Obstructive Pulmonary Disease (COPD)|Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
11374977|NCT04860258|FG002|Participant Flow|Obesity|Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a body mass index (BMI) >32 kg/m².
11374978|NCT04860258|FG003|Participant Flow|Chronic Cardiovascular Disease|Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
11374979|NCT04860258|FG004|Participant Flow|Chronic Human Immunodeficiency Virus (HIV) Infection|Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
11374980|NCT04860258|FG005|Participant Flow|Type 2 Diabetes Mellitus|Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
11374981|NCT04860258|FG006|Participant Flow|Renal Transplant|Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
11374982|NCT04860258|OG000|Outcome|Chronic Kidney Disease|Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
11374983|NCT04860258|OG001|Outcome|COPD|Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
11374984|NCT04860258|OG002|Outcome|Obesity|Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
11374985|NCT04860258|OG003|Outcome|Chronic Cardiovascular Disease|Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
11374986|NCT04860258|OG004|Outcome|Chronic HIV Infection|Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
11374987|NCT04860258|OG005|Outcome|Type 2 Diabetes Mellitus|Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
11374988|NCT04860258|OG006|Outcome|Renal Transplant|Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
11377183|NCT03850444|OG000|Outcome|Pembrolizumab-China Extension|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
11374989|NCT04860258|EG000|Reported Event|Chronic Kidney Disease|Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
11374990|NCT04860258|EG001|Reported Event|COPD|Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
11374991|NCT04860258|EG002|Reported Event|Obesity|Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
11374992|NCT04860258|EG003|Reported Event|Chronic Cardiovascular Disease|Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
11374993|NCT04860258|EG004|Reported Event|Chronic HIV Infection|Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
11374994|NCT04860258|EG005|Reported Event|Type 2 Diabetes Mellitus|Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
11374995|NCT04860258|EG006|Reported Event|Renal Transplant|Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
11376914|NCT01659151|OG000|Outcome|Combination Therapy|"Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).~High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.~ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).~Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.~Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."
11376915|NCT01659151|EG000|Reported Event|Combination Therapy|"Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).~High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.~ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).~Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.~Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."
11376916|NCT01634048|BG000|Baseline|High Protein Low Calorie Meal Replacements|"Meal replacements with added protein powder(1.34g pro/kg).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376917|NCT01634048|BG001|Baseline|Normal Protein, Low Calorie Meal Replacement Group|"The control group will have standard meal replacements (0.8g protein/kg body weight).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376918|NCT01634048|BG002|Baseline|Total|Total of all reporting groups
11376919|NCT01634048|FG000|Participant Flow|High Protein Low Calorie Meal Replacements|"Meal replacements with added protein powder(1.34g pro/kg).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376920|NCT01634048|FG001|Participant Flow|Normal Protein, Low Calorie Meal Replacement Group|"The control group will have standard meal replacements (0.8g protein/kg body weight).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11240575|NCT02480582|FG001|Participant Flow|Cheese Savouries Then Almond, Then No Food|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.
11374996|NCT04428645|BG000|Baseline|DailyDose Decision Support|"Subjects will use DailyDose decision support for 8 weeks at home.~DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model."
11374997|NCT04428645|FG000|Participant Flow|DailyDose Decision Support|"Subjects will use DailyDose decision support for 8 weeks at home.~DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model."
11374998|NCT04428645|OG000|Outcome|DailyDose Decision Support|"Subjects will use DailyDose decision support for 8 weeks at home.~DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model."
11374999|NCT04428645|EG000|Reported Event|DailyDose Decision Support|"Subjects will use DailyDose decision support for 8 weeks at home.~DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model."
11375000|NCT04318210|BG000|Baseline|TDF-FTC as PrEP|"Eligible HIV-uninfected participants were offered 12 months of oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet regardless of their original study assignment in randomized phase.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg"
11375001|NCT04318210|FG000|Participant Flow|TDF-FTC as PrEP|"Eligible HIV-uninfected participants were offered 12 months of oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet regardless of their original study assignment in randomized phase.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg"
11375002|NCT04318210|OG000|Outcome|TDF-FTC as PrEP|"Eligible HIV-uninfected participants were offered 12 months of oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet regardless of their original study assignment in randomized phase.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg"
11375003|NCT04318210|EG000|Reported Event|TDF-FTC as PrEP|"Eligible HIV-uninfected participants were offered 12 months of oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet regardless of their original study assignment in randomized phase.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg"
11375004|NCT04237207|BG000|Baseline|Aidable Residual Hearing (ARH) Cohort|"Control Device followed by experimental Device.~Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11240576|NCT02480582|FG002|Participant Flow|No Food, Then Cheese Savouries, Then Almond|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.
11240577|NCT02480582|FG003|Participant Flow|Cheese Savouries, Then No Food, Then Almond|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.
11190928|NCT02129608|FG000|Participant Flow|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
11190929|NCT02129608|FG001|Participant Flow|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11191813|NCT02134184|FG001|Participant Flow|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11375005|NCT04237207|BG001|Baseline|Electric Only (EO) Cohort|"Control Device followed by experimental Device.~Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375006|NCT04237207|BG002|Baseline|Total|Total of all reporting groups
11375007|NCT04237207|FG000|Participant Flow|Electric Only (EO) Cohort|"Control Device followed by experimental Device.~Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375008|NCT04237207|FG001|Participant Flow|Aidable Residual Hearing (ARH) Cohort|"Control Device followed by experimental Device.~Naída Cochlea Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375009|NCT04237207|OG000|Outcome|EO Cohort|"Control Device followed by experimental Device.~Naída CI Q90 sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375010|NCT04237207|OG001|Outcome|ARH Cohort|"Control Device followed by experimental Device.~Naída CI Q90 sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375011|NCT04237207|EG000|Reported Event|EO Cohort|"Control Device followed by experimental Device.~Naída CI Q90 sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11375012|NCT04237207|EG001|Reported Event|ARH Cohort|"Control Device followed by experimental Device.~Naída CI Q90 sound processor & software: Control cochlear implant sound processor~301-M062 sound processor & software: New cochlear implant sound processor"
11376921|NCT01634048|OG000|Outcome|High Protein Low Calorie Meal Replacements|"Meal replacements with added protein powder(1.34g pro/kg).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376922|NCT01634048|OG001|Outcome|Normal Protein, Low Calorie Meal Replacement Group|"The control group will have standard meal replacements (0.8g protein/kg body weight).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376923|NCT01634048|EG000|Reported Event|High Protein Low Calorie Meal Replacements|"Meal replacements with added protein powder(1.34g pro/kg).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376924|NCT01634048|EG001|Reported Event|Normal Protein, Low Calorie Meal Replacement Group|"The control group will have standard meal replacements (0.8g protein/kg body weight).~High Protein, low calorie meal replacement: The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects."
11376925|NCT01539863|BG000|Baseline|Treatment at Regular Intervals|"Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management~maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor"
11376926|NCT01539863|BG001|Baseline|Treatment as Needed|"Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration~Treatment as needed: Participants may never receive treatment, there is no upper limit"
11376927|NCT01539863|BG002|Baseline|Total|Total of all reporting groups
11376928|NCT01539863|FG000|Participant Flow|Treatment at Regular Intervals|"Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management~maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor"
11376929|NCT01539863|FG001|Participant Flow|Treatment as Needed|"Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration~Treatment as needed: Participants may never receive treatment, there is no upper limit"
11376930|NCT01539863|OG000|Outcome|Treatment at Regular Intervals|"Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management~maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor"
11376931|NCT01539863|OG001|Outcome|Treatment as Needed|"Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration~Treatment as needed: Participants may never receive treatment, there is no upper limit"
11240578|NCT02480582|FG004|Participant Flow|Almond, Then Cheese Savouries, Then No Food|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.
11375013|NCT03787303|BG000|Baseline|Triiodothyronine (T3)|"Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3).~Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated."
11375014|NCT03787303|FG000|Participant Flow|Triiodothyronine (T3)|"Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3).~Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated."
11375015|NCT03787303|OG000|Outcome|Triiodothyronine (T3)|"Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3).~Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated."
11375016|NCT03787303|EG000|Reported Event|Triiodothyronine (T3)|"Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3).~Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated."
11375017|NCT03702283|BG000|Baseline|Intervention Group- Single Arm|"This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk.~During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin, and 205/240 (85.4%) patients agreed."
11375018|NCT03702283|FG000|Participant Flow|Intervention Group- Single Arm|This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk.
11375019|NCT03702283|OG000|Outcome|Intervention Group- Single Arm|"This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk.~During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin, and 205/240 (85.4%) patients agreed."
11190930|NCT02129608|FG002|Participant Flow|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11190931|NCT02129608|OG000|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
11190932|NCT02129608|OG001|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11190933|NCT02129608|OG002|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11190934|NCT02129608|EG000|Reported Event|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
11375020|NCT03702283|EG000|Reported Event|Intervention Group- Single Arm|"This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk.~During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin, and 205/240 (85.4%) patients agreed."
11375021|NCT03673098|BG000|Baseline|Intervention Group: Adapted 3RP|"The intervention condition will consist of the 10-week adapted 3RP intervention.~Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot)."
11375022|NCT03673098|BG001|Baseline|Control Group: Supportive Psychotherapy|The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
11375023|NCT03673098|BG002|Baseline|Total|Total of all reporting groups
11375024|NCT03673098|FG000|Participant Flow|Intervention Group: Adapted 3RP|"The intervention condition will consist of the 10-week adapted 3RP intervention.~Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot)."
11375025|NCT03673098|FG001|Participant Flow|Control Group: Supportive Psychotherapy|The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
11375026|NCT03673098|OG000|Outcome|Total Recruitment Population|Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.
11375027|NCT03673098|OG000|Outcome|Intervention Group: Adapted 3RP|"The intervention condition will consist of the 10-week adapted 3RP intervention.~Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot)."
11375028|NCT03673098|OG001|Outcome|Control Group: Supportive Psychotherapy|The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
11375029|NCT03673098|OG000|Outcome|Overall|Total participants (includes both control and intervention)
11375030|NCT03673098|OG002|Outcome|Overall|Total participants (includes both control and intervention)
11375031|NCT03673098|OG000|Outcome|Overall|Total participants eligible, but declined to enroll.
11375032|NCT03673098|OG002|Outcome|Overall|Total participants that enrolled, but did not take part in the group sessions.
11375033|NCT03673098|OG002|Outcome|Overall|Total participants that withdrew participation in the study.
11375034|NCT03673098|OG002|Outcome|Overall|Total participants that were lost to follow-up.
11375035|NCT03673098|EG000|Reported Event|Intervention Group: Adapted 3RP|"The intervention condition will consist of the 10-week adapted 3RP intervention.~Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot)."
11375036|NCT03673098|EG001|Reported Event|Control Group: Supportive Psychotherapy|The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
11375037|NCT03525678|BG000|Baseline|GSK2857916 2.5 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375038|NCT03525678|BG001|Baseline|GSK2857916 3.4 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11190935|NCT02129608|EG001|Reported Event|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11240579|NCT02480582|FG005|Participant Flow|No Food, Then Almond, Then Cheese Savouries|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
11240580|NCT02480582|OG000|Outcome|Almonds|Whole, raw almonds Almonds
11240581|NCT02480582|OG001|Outcome|Cheese Savouries|Sainsbury's savoury biscuits Cheese Savouries
11190936|NCT02129608|EG002|Reported Event|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
11375039|NCT03525678|BG002|Baseline|GSK2857916 3.4 mg/kg (Lyophilized)|Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
11375040|NCT03525678|BG003|Baseline|Total|Total of all reporting groups
11375041|NCT03525678|FG000|Participant Flow|GSK2857916 2.5 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375042|NCT03525678|FG001|Participant Flow|GSK2857916 3.4 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375043|NCT03525678|FG002|Participant Flow|GSK2857916 3.4 mg/kg (Lyophilized)|Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
11375044|NCT03525678|OG000|Outcome|GSK2857916 2.5 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375045|NCT03525678|OG001|Outcome|GSK2857916 3.4 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375046|NCT03525678|OG002|Outcome|GSK2857916 3.4 mg/kg (Lyophilized)|Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
11375047|NCT03525678|EG000|Reported Event|GSK2857916 2.5 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375048|NCT03525678|EG001|Reported Event|GSK2857916 3.4 mg/kg (Frozen Liquid)|Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
11375049|NCT03525678|EG002|Reported Event|GSK2857916 3.4 mg/kg (Lyophilized)|Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
11375050|NCT03520569|BG000|Baseline|All Participants|all participants who completed the study
11375051|NCT03520569|FG000|Participant Flow|All Participants|All participants enrolled who completed at least one arm of the crossover assignment.
11375052|NCT03520569|OG000|Outcome|Octreotide- Euglycemia|"octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375053|NCT03520569|OG001|Outcome|Octreotide - Euglycemia- Insulin Clamp|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375054|NCT03520569|OG002|Outcome|Octreotide- Hyperglycemia|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11190937|NCT02129660|BG000|Baseline|Dose 1 of Glycopyrrolate|Dose 1 of glycopyrrolate Topical Wipes
11190938|NCT02129660|BG001|Baseline|Dose 2 of Glycopyrrolate|Dose 2 of glycopyrrolate Topical Wipes
11190939|NCT02129660|BG002|Baseline|Dose 1 of Glycopyrronium|Dose 1 of glycopyrronium Topical Wipes
11190940|NCT02129660|BG003|Baseline|Dose 2 of Glycopyrronium|Dose 2 of glycopyrronium Topical Wipes
11190941|NCT02129660|BG004|Baseline|Vehicle|Vehicle Topical Wipes
11375055|NCT03520569|OG003|Outcome|Octreotide- Hyperglycemia - Insulin Clamp|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375056|NCT03520569|EG000|Reported Event|Octreotide- Euglycemia|"octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375057|NCT03520569|EG001|Reported Event|Octreotide - Euglycemia- Insulin Clamp|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375058|NCT03520569|EG002|Reported Event|Octreotide- Hyperglycemia|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375059|NCT03520569|EG003|Reported Event|Octreotide- Hyperglycemia - Insulin Clamp|"octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min~Octreotide: we are using it to block insulin secretion from the pancreas~Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp~Dextrose 20% solution: We are using dextrose to maintain glycemia level"
11375060|NCT03499899|BG000|Baseline|LAG525 + Spartalizumab|Participants received LAG525 and spartalizumab administered as infusion once every 3 weeks
11375061|NCT03499899|BG001|Baseline|LAG525+ Spartalizumab+ Carboplatin|Participants received LAG525, spartalizumab and carboplatin administered as infusion once every 3 weeks.
11375062|NCT03499899|BG002|Baseline|LAG525 + Carboplatin|Participants received LAG525 and carboplatin administered as infusion once every 3 weeks
11375063|NCT03499899|BG003|Baseline|Total|Total of all reporting groups
11375064|NCT03499899|FG000|Participant Flow|LAG525 + Spartalizumab|Participants received LAG525 and spartalizumab administered as infusion once every 3 weeks
11375065|NCT03499899|FG001|Participant Flow|LAG525+ Spartalizumab+ Carboplatin|Participants received LAG525, spartalizumab and carboplatin administered as infusion once every 3 weeks.
11375066|NCT03499899|FG002|Participant Flow|LAG525 + Carboplatin|Participants received LAG525 and carboplatin administered as infusion once every 3 weeks
11375067|NCT03499899|OG000|Outcome|LAG525 + Spartalizumab|Participants received LAG525 and spartalizumab administered as infusion once every 3 weeks
11375068|NCT03499899|OG001|Outcome|LAG525+ Spartalizumab+ Carboplatin|Participants received LAG525, spartalizumab and carboplatin administered as infusion once every 3 weeks.
11375069|NCT03499899|OG002|Outcome|LAG525 + Carboplatin|Participants received LAG525 and carboplatin administered as infusion once every 3 weeks
11375070|NCT03499899|EG000|Reported Event|LAG525 + Spartalizumab|Participants received LAG525 and spartalizumab administered as infusion once every 3 weeks
11375071|NCT03499899|EG001|Reported Event|LAG525 + Spartalizumab +Carboplatin|Participants received LAG525, spartalizumab and carboplatin administered as infusion once every 3 weeks.
11375072|NCT03499899|EG002|Reported Event|LAG525 + Carboplatin|Participants received LAG525 and carboplatin administered as infusion once every 3 weeks
11375073|NCT03462563|BG000|Baseline|Treatment Arm: INTERCEED|In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).
11375074|NCT03462563|BG001|Baseline|Control Arm: Standard of Care (SOC)|Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
11375075|NCT03462563|BG002|Baseline|Total|Total of all reporting groups
11375076|NCT03462563|FG000|Participant Flow|Treatment Arm: INTERCEED|In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).
11375077|NCT03462563|FG001|Participant Flow|Control Arm: Standard of Care (SOC)|Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
11375078|NCT03462563|OG000|Outcome|Treatment Arm: INTERCEED|In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).
11375079|NCT03462563|OG001|Outcome|Control Arm: Standard of Care (SOC)|Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
11375080|NCT03462563|EG000|Reported Event|Treatment Arm: INTERCEED|In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).
11190942|NCT02129660|BG005|Baseline|Total|Total of all reporting groups
10962928|NCT00869167|EG001|Reported Event|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
10962929|NCT00869206|BG000|Baseline|Arm I (Zoledronic Acid Every 4 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962930|NCT00869206|BG001|Baseline|Arm II (Zoledronic Acid Every 12 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962931|NCT00869206|BG002|Baseline|Total|Total of all reporting groups
11190943|NCT02129660|FG000|Participant Flow|Dose 1 of Glycopyrrolate|Dose 1 of glycopyrrolate Topical Wipes
11190944|NCT02129660|FG001|Participant Flow|Dose 2 of Glycopyrrolate|Dose 2 of glycopyrrolate Topical Wipes
11190945|NCT02129660|FG002|Participant Flow|Dose 1 of Glycopyrronium|Dose 1 of glycopyrronium Topical Wipes
10962932|NCT00869206|FG000|Participant Flow|Arm I (Zoledronic Acid Every 4 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
11190946|NCT02129660|FG003|Participant Flow|Dose 2 of Glycopyrronium|Dose 2 of glycopyrronium Topical Wipes
11190947|NCT02129660|FG004|Participant Flow|Vehicle|Vehicle Topical Wipes
11190948|NCT02129660|OG000|Outcome|Dose 1 of Glycopyrrolate|Dose 1 of glycopyrrolate Topical Wipes
11190949|NCT02129660|OG001|Outcome|Dose 2 of Glycopyrrolate|Dose 2 of glycopyrrolate Topical Wipes
11190950|NCT02129660|OG002|Outcome|Dose 1 of Glycopyrronium|Dose 1 of glycopyrronium Topical Wipes
11190951|NCT02129660|OG003|Outcome|Dose 2 of Glycopyrronium|Dose 2 of glycopyrronium Topical Wipes
11190952|NCT02129660|OG004|Outcome|Vehicle|Vehicle Topical Wipes
11190953|NCT02129660|OG001|Outcome|Dose 2 of Glycopyrrolate|Dose 2 of glycopyrrolate Topical wipes
11190954|NCT02129660|EG000|Reported Event|Dose 1 of Glycopyrrolate|Dose 1 of glycopyrrolate Topical Wipes
11190955|NCT02129660|EG001|Reported Event|Dose 2 of Glycopyrrolate|Dose 2 of glycopyrrolate Topical Wipes
11190956|NCT02129660|EG002|Reported Event|Dose 1 of Glycopyrronium|Dose 1 of glycopyrronium Topical Wipes
11190957|NCT02129660|EG003|Reported Event|Dose 2 of Glycopyrronium|Dose 2 of glycopyrronium Topical Wipes
11190958|NCT02129660|EG004|Reported Event|Vehicle|Vehicle Topical Wipes
11190959|NCT02129725|BG000|Baseline|Sildenafil|Subjects consented for the biopsy substudy and randomized
11190960|NCT02129725|BG001|Baseline|Placebo|Subjects consented for the biopsy substudy and randomized
11190961|NCT02129725|BG002|Baseline|Total|Total of all reporting groups
11240582|NCT02480582|OG002|Outcome|No Food|No food provided, just water
11240583|NCT02480582|OG000|Outcome|Almonds|"Whole, raw almonds~Almonds"
11190962|NCT02129725|FG000|Participant Flow|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
11240584|NCT02480582|OG001|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
11375081|NCT03462563|EG001|Reported Event|Control Arm: Standard of Care (SOC)|Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
11190963|NCT02129725|FG001|Participant Flow|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
11190964|NCT02129725|OG000|Outcome|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
11190965|NCT02129725|OG001|Outcome|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
11190966|NCT02129725|EG000|Reported Event|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
11190967|NCT02129725|EG001|Reported Event|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
10962933|NCT00869206|FG001|Participant Flow|Arm II (Zoledronic Acid Every 12 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
11375082|NCT03419741|BG000|Baseline|Active rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375083|NCT03419741|BG001|Baseline|Sham rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375084|NCT03419741|BG002|Baseline|Total|Total of all reporting groups
11375085|NCT03419741|FG000|Participant Flow|Active rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375086|NCT03419741|FG001|Participant Flow|Sham rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375087|NCT03419741|OG000|Outcome|Active rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375088|NCT03419741|OG001|Outcome|Sham rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375089|NCT03419741|EG000|Reported Event|Active rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375090|NCT03419741|EG001|Reported Event|Sham rTMS Treatment|"Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.~Transcranial Magnetic Stimulation Clinical Research System: Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil."
11375091|NCT03401918|BG000|Baseline|Patients With Recurrent Pregnancy Loss or Unexplained Infertility|"Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.~Those who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome."
11375092|NCT03401918|BG001|Baseline|Healthy Control Patients|Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.
11375093|NCT03401918|BG002|Baseline|Total|Total of all reporting groups
11190968|NCT02129777|BG000|Baseline|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190969|NCT02129777|BG001|Baseline|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190970|NCT02129777|BG002|Baseline|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190971|NCT02129777|BG003|Baseline|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190972|NCT02129777|BG004|Baseline|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190973|NCT02129777|BG005|Baseline|Total|Total of all reporting groups
11190974|NCT02129777|FG000|Participant Flow|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190975|NCT02129777|FG001|Participant Flow|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
10962934|NCT00869206|OG000|Outcome|Arm I (Zoledronic Acid Every 4 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962935|NCT00869206|OG001|Outcome|Arm II (Zoledronic Acid Every 12 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962936|NCT00869206|OG000|Outcome|Breast Cancer 4 Weeks|Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962937|NCT00869206|OG001|Outcome|Breast Cancer 12 Weeks|Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
11190976|NCT02129777|FG002|Participant Flow|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190977|NCT02129777|FG003|Participant Flow|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
10962938|NCT00869206|OG000|Outcome|Prostate Cancer 4 Weeks|Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962939|NCT00869206|OG001|Outcome|Prostate Cancer 12 Weeks|Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962940|NCT00869206|OG000|Outcome|Multiple Myeloma 4 Weeks|Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962941|NCT00869206|OG001|Outcome|Multiple Myeloma 12 Weeks|Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962942|NCT00869206|EG000|Reported Event|Arm I (Zoledronic Acid Every 4 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962943|NCT00869206|EG001|Reported Event|Arm II (Zoledronic Acid Every 12 Weeks)|Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
10962944|NCT00869323|BG000|Baseline|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
10962945|NCT00869323|FG000|Participant Flow|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
10962946|NCT00869323|OG000|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
10963969|NCT00875212|EG000|Reported Event|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
10963970|NCT00875277|BG000|Baseline|All Randomized Participants|All randomized participants received the six products on six different test sites.
11190978|NCT02129777|FG004|Participant Flow|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190979|NCT02129777|FG005|Participant Flow|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
11190980|NCT02129777|FG006|Participant Flow|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
11190981|NCT02129777|OG000|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11240585|NCT02480582|EG000|Reported Event|Almond, Then No Food, Then Cheese Savouries|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
10962947|NCT00869323|EG000|Reported Event|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
10962948|NCT00869349|BG000|Baseline|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
10962949|NCT00869349|BG001|Baseline|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
10962950|NCT00869349|BG002|Baseline|Total|Total of all reporting groups
10962951|NCT00869349|FG000|Participant Flow|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
10962952|NCT00869349|FG001|Participant Flow|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
10962953|NCT00869349|OG000|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
10962954|NCT00869349|OG001|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
10962955|NCT00869349|EG000|Reported Event|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
10962956|NCT00869349|EG001|Reported Event|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
10962957|NCT00869362|BG000|Baseline|Diabetes Management Team|Evaluation and management by diabetes management team
10962958|NCT00869362|BG001|Baseline|Control|Patients receive usual care for diabetes
10962959|NCT00869362|BG002|Baseline|Total|Total of all reporting groups
10962960|NCT00869362|FG000|Participant Flow|Diabetes Management Team|Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.
10962961|NCT00869362|FG001|Participant Flow|Control|Patients receive usual care for diabetes
10962962|NCT00869362|OG000|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.
10962963|NCT00869362|OG001|Outcome|Control|Patients receive usual care for diabetes
10962964|NCT00869362|OG000|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team
10962965|NCT00869362|EG000|Reported Event|Diabetes Management Team|Evaluation and management by diabetes management team
10962966|NCT00869362|EG001|Reported Event|Control|Patients receive usual care for diabetes
10962967|NCT00869375|BG000|Baseline|CLEARWAY GROUP|3 patients were randomized in this group.
10962968|NCT00869375|BG001|Baseline|ANGIOJET GROUP|3 patients were randomized in this group
11376932|NCT01539863|EG000|Reported Event|Treatment at Regular Intervals|"Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management~maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor"
10962969|NCT00869375|BG002|Baseline|Total|Total of all reporting groups
10962970|NCT00869375|FG000|Participant Flow|CLEARWAY GROUP|3 patients were randomized in this group.
10962971|NCT00869375|FG001|Participant Flow|ANGIOJET GROUP|3 patients were randomized in this group
10962972|NCT00869375|OG000|Outcome|CLEARWAY GROUP|No patients had distal embolization
10962973|NCT00869375|OG001|Outcome|ANGIOJET GROUP|No patients had distal embolization
10962974|NCT00869375|OG000|Outcome|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
10962975|NCT00869375|OG001|Outcome|ANGIOJET GROUP|3 patients were randomized in this group
10962976|NCT00869375|EG000|Reported Event|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
10962977|NCT00869375|EG001|Reported Event|ANGIOJET GROUP|3 patients were randomized in this group
10962978|NCT00869401|BG000|Baseline|Phase I|All patients included in the Phase I portion of the study were published together for this results portion.
10962979|NCT00869401|BG001|Baseline|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962980|NCT00869401|BG002|Baseline|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
10962981|NCT00869401|BG003|Baseline|Total|Total of all reporting groups
10962982|NCT00869401|FG000|Participant Flow|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
10962983|NCT00869401|FG001|Participant Flow|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
10962984|NCT00869401|FG002|Participant Flow|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962985|NCT00869401|FG003|Participant Flow|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962986|NCT00869401|FG004|Participant Flow|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
10962987|NCT00869401|OG000|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962988|NCT00869401|OG001|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
11240586|NCT02480582|EG001|Reported Event|Cheese Savouries Then Almond, Then No Food|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11376933|NCT01539863|EG001|Reported Event|Treatment as Needed|"Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration~Treatment as needed: Participants may never receive treatment, there is no upper limit"
11376934|NCT01505062|BG000|Baseline|Cohort 1|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^5 TU per eye.
11376935|NCT01505062|BG001|Baseline|Cohort 2|Participants received subretinally a single injection of SAR421869 at target dose of 4.7*10^5 TU per eye.
11375094|NCT03401918|FG000|Participant Flow|Patients With Recurrent Pregnancy Loss or Unexplained Infertility|"Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.~Those who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome."
11375095|NCT03401918|FG001|Participant Flow|Healthy Control Patients|Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.
11375096|NCT03401918|OG000|Outcome|Patients With Recurrent Pregnancy Loss or Unexplained Infertility|"Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.~Those who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome."
11375097|NCT03401918|OG001|Outcome|Healthy Control Patients|Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.
11375098|NCT03401918|EG000|Reported Event|Patients With Recurrent Pregnancy Loss or Unexplained Infertility|"Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.~Those who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome."
11375099|NCT03401918|EG001|Reported Event|Healthy Control Patients|Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.
11376936|NCT01505062|BG002|Baseline|Cohort 3|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^6 TU per eye.
11376937|NCT01505062|BG003|Baseline|Total|Total of all reporting groups
11376938|NCT01505062|FG000|Participant Flow|Cohort 1|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^5 transducing units (TU) per eye.
11376939|NCT01505062|FG001|Participant Flow|Cohort 2|Participants received subretinally a single injection of SAR421869 at target dose of 4.7*10^5 TU per eye.
11376940|NCT01505062|FG002|Participant Flow|Cohort 3|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^6 TU per eye.
11376941|NCT01505062|OG000|Outcome|Cohort 1|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^5 TU per eye.
11376942|NCT01505062|OG001|Outcome|Cohort 2|Participants received subretinally a single injection of SAR421869 at target dose of 4.7*10^5 TU per eye.
11240587|NCT02480582|EG002|Reported Event|No Food, Then Cheese Savouries, Then Almond|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11376943|NCT01505062|OG002|Outcome|Cohort 3|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^6 TU per eye.
11376944|NCT01505062|EG000|Reported Event|Cohort 1|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^5 TU per eye.
11376945|NCT01505062|EG001|Reported Event|Cohort 2|Participants received subretinally a single injection of SAR421869 at target dose of 4.7*10^5 TU per eye.
11376946|NCT01505062|EG002|Reported Event|Cohort 3|Participants received subretinally a single injection of SAR421869 at target dose of 1.4*10^6 TU per eye.
11376947|NCT01439165|BG000|Baseline|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
11376948|NCT01439165|BG001|Baseline|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
11376949|NCT01439165|BG002|Baseline|Total|Total of all reporting groups
11376950|NCT01439165|FG000|Participant Flow|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
11376951|NCT01439165|FG001|Participant Flow|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
11376952|NCT01439165|OG000|Outcome|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
11376953|NCT01439165|OG001|Outcome|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
11376954|NCT01439165|EG000|Reported Event|Adacel Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
11376955|NCT01439165|EG001|Reported Event|Td Adsorbed Vaccine|Healthy adults <65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
11376956|NCT01264679|BG000|Baseline|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
11375100|NCT02759185|BG000|Baseline|High THC Cannabis|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11375101|NCT02759185|BG001|Baseline|High CBD Cannabis|"Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375102|NCT02759185|BG002|Baseline|High THC/ High CBD Cannabis|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~High THC/high CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day."
11375103|NCT02759185|BG003|Baseline|Placebo Cannabis|"Provided 1.8 g of cannabis per day a with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD, with smoking limited to no more than 1.8 per day."
11375104|NCT02759185|BG004|Baseline|Total|Total of all reporting groups
11375105|NCT02759185|FG000|Participant Flow|High THC Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11375106|NCT02759185|FG001|Participant Flow|High CBD Cannabis (Stage 1)|"Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375107|NCT02759185|FG002|Participant Flow|THC/CBD Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375108|NCT02759185|FG003|Participant Flow|Placebo Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day."
11375109|NCT02759185|FG004|Participant Flow|High THC Cannabis (Stage 2)|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11375110|NCT02759185|FG005|Participant Flow|High CBD Cannabis (Stage 2)|"Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375111|NCT02759185|FG006|Participant Flow|THC/CBD Cannabis (Stage 2)|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375112|NCT02759185|OG000|Outcome|High THC Cannabis|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11375113|NCT02759185|OG001|Outcome|High CBD Cannabis|"Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375114|NCT02759185|OG002|Outcome|THC/CBD Cannabis|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375115|NCT02759185|OG003|Outcome|Placebo Cannabis|"Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day."
11375116|NCT02759185|OG001|Outcome|High CBD Cannabis|"Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375117|NCT02759185|OG002|Outcome|THC/CBD Cannabis|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~High THC/high CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375118|NCT02759185|OG003|Outcome|Placebo Cannabis|"Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day."
11375119|NCT02759185|OG002|Outcome|THC/CBD Cannabis|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375120|NCT02759185|OG003|Outcome|Placebo Cannabis|"Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: three weeks of smoking cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day."
11375121|NCT02759185|OG000|Outcome|High CBD Cannabis|"Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day."
11375122|NCT02759185|OG001|Outcome|High THC Cannabis|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day."
11375123|NCT02759185|OG002|Outcome|THC/CBD Cannabis|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day."
11375124|NCT02759185|OG003|Outcome|Placebo Cannabis|"Provided 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day."
11240588|NCT02480582|EG003|Reported Event|Cheese Savouries, Then No Food, Then Almond|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11240589|NCT02480582|EG004|Reported Event|Almond, Then Cheese Savouries, Then No Food|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11240590|NCT02480582|EG005|Reported Event|No Food, Then Almond, Then Cheese Savouries|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11240591|NCT02480621|BG000|Baseline|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
11240592|NCT02480621|BG001|Baseline|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
11375125|NCT02759185|EG000|Reported Event|High THC Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11190982|NCT02129777|OG001|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375126|NCT02759185|EG001|Reported Event|High CBD Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375127|NCT02759185|EG002|Reported Event|THC/CBD Cannabis (Stage 1)|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day."
11375128|NCT02759185|EG003|Reported Event|Placebo Cannabis (Stage 1)|"Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol~Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day."
11375129|NCT02759185|EG004|Reported Event|High THC Cannabis (Stage 2)|"Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol~High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day."
11375130|NCT02759185|EG005|Reported Event|High CBD Cannabis (Stage 2)|"Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol~High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375131|NCT02759185|EG006|Reported Event|THC/CBD Cannabis (Stage 2)|"Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol~THC/CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day."
11375132|NCT02704156|BG000|Baseline|SBRT Plus Gemcitabine|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Gemcitabine: Radiation therapy plus drug"
11375133|NCT02704156|BG001|Baseline|SBRT Plus Pembrolizumab and Trametinib|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug"
11375134|NCT02704156|BG002|Baseline|Total|Total of all reporting groups
11375135|NCT02704156|FG000|Participant Flow|SBRT Plus Gemcitabine|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Gemcitabine: Radiation therapy plus drug"
11190983|NCT02129777|OG002|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375136|NCT02704156|FG001|Participant Flow|SBRT Plus Pembrolizumab and Trametinib|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug"
11375137|NCT02704156|OG000|Outcome|SBRT Plus Gemcitabine|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Gemcitabine: Radiation therapy plus drug"
11375138|NCT02704156|OG001|Outcome|SBRT Plus Pembrolizumab and Trametinib|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug"
11375139|NCT02704156|EG000|Reported Event|SBRT Plus Gemcitabine|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Gemcitabine: Radiation therapy plus drug"
11375140|NCT02704156|EG001|Reported Event|SBRT Plus Pembrolizumab and Trametinib|"Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.~Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug"
11375141|NCT02688530|BG000|Baseline|0mg IV Dexamethasone|0mg IV Dexamethasone
11375142|NCT02688530|BG001|Baseline|4mg IV Dexamethasone|4mg IV Dexamethasone
11375143|NCT02688530|BG002|Baseline|6mg IV Dexamethasone|6mg IV Dexamethasone
11190984|NCT02129777|OG003|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375144|NCT02688530|BG003|Baseline|8mg IV Dexamethasone|8mg IV Dexamethasone
11375145|NCT02688530|BG004|Baseline|Total|Total of all reporting groups
11375146|NCT02688530|FG000|Participant Flow|0mg IV Dexamethasone|"0mg IV Dexamethasone~IV Saline"
11375147|NCT02688530|FG001|Participant Flow|4mg IV Dexamethasone|"4mg IV Dexamethasone~IV Dexamethasone 4mg"
11375148|NCT02688530|FG002|Participant Flow|6mg IV Dexamethasone|"6mg IV Dexamethasone~IV Dexamethasone 6mg"
11375149|NCT02688530|FG003|Participant Flow|8mg IV Dexamethasone|"8mg IV Dexamethasone~IV Dexamethasone 8mg"
11190985|NCT02129777|OG004|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190986|NCT02129777|EG000|Reported Event|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375150|NCT02688530|OG000|Outcome|0mg IV Dexamethasone|0mg IV Dexamethasone
11375151|NCT02688530|OG001|Outcome|4mg IV Dexamethasone|4mg IV Dexamethasone
11375152|NCT02688530|OG002|Outcome|6mg IV Dexamethasone|6mg IV Dexamethasone
11375153|NCT02688530|OG003|Outcome|8mg IV Dexamethasone|8mg IV Dexamethasone
11375154|NCT02688530|OG000|Outcome|0mg IV Dexamethasone|"0mg IV Dexamethasone~IV Saline"
11375155|NCT02688530|OG001|Outcome|4mg IV Dexamethasone|"4mg IV Dexamethasone~IV Dexamethasone 4mg"
11375156|NCT02688530|OG002|Outcome|6mg IV Dexamethasone|"6mg IV Dexamethasone~IV Dexamethasone 6mg"
11375157|NCT02688530|OG003|Outcome|8mg IV Dexamethasone|"8mg IV Dexamethasone~IV Dexamethasone 8mg"
11375158|NCT02688530|EG000|Reported Event|0mg IV Dexamethasone|0 mg IV Dexamethasone Adverse Event
11375159|NCT02688530|EG001|Reported Event|4mg IV Dexamethasone|4 mg IV Dexamethasone Adverse Event
11375160|NCT02688530|EG002|Reported Event|6mg IV Dexamethasone|6 mg IV Dexamethasone Adverse Event
11375161|NCT02688530|EG003|Reported Event|8mg IV Dexamethasone|8 mg IV Dexamethasone Adverse Event
11375162|NCT02657434|BG000|Baseline|Arm B (Carboplatin or Cisplatin + Pemetrexed)|Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11240593|NCT02480621|BG002|Baseline|Total|Total of all reporting groups
11375163|NCT02657434|BG001|Baseline|Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed|Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375164|NCT02657434|BG002|Baseline|Total|Total of all reporting groups
11375165|NCT02657434|FG000|Participant Flow|Arm B (Carboplatin or Cisplatin + Pemetrexed)|Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375166|NCT02657434|FG001|Participant Flow|Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed|Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375167|NCT02657434|OG000|Outcome|Arm B (Carboplatin or Cisplatin + Pemetrexed)|Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375168|NCT02657434|OG001|Outcome|Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed|Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375169|NCT02657434|OG000|Outcome|Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed|Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375170|NCT02657434|EG000|Reported Event|Arm B (Carboplatin or Cisplatin + Pemetrexed)|Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375171|NCT02657434|EG001|Reported Event|Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed|Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
11375172|NCT02383966|BG000|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil|Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
11375173|NCT02383966|BG001|Baseline|Cisplatin/Carboplatin + 5-Flurouracil|Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
11375174|NCT02383966|BG002|Baseline|Total|Total of all reporting groups
11375175|NCT02383966|FG000|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil|Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
11375176|NCT02383966|FG001|Participant Flow|Cisplatin/Carboplatin + 5-Flurouracil|Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
11375177|NCT02383966|OG000|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil|Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
11375178|NCT02383966|OG001|Outcome|Cisplatin/Carboplatin + 5-Flurouracil|Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
11376957|NCT01264679|FG000|Participant Flow|Ferumoxytol|When a participant had persistent or recurrent iron deficiency anemia (IDA) (defined as hemoglobin <12.0 grams [g]/deciliter [dL] and with either transferrin saturation [TSAT] <40% or ferritin <100 nanograms [ng]/milliliter [mL]), the participant began a 7-week treatment period. Participants received 2 intravenous (IV) injections of ferumoxytol 7.0 milligrams [mg] iron (Fe)/kilogram (kg) (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
11190987|NCT02129777|EG001|Reported Event|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375179|NCT02383966|EG000|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil|Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
11375180|NCT02383966|EG001|Reported Event|Cisplatin/Carboplatin + 5-Flurouracil|Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
11375181|NCT02073565|BG000|Baseline|Combo|"The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.~OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface."
11375182|NCT02073565|BG001|Baseline|Everolimus Eluting Stent (EES)|"Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.~Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V."
11375183|NCT02073565|BG002|Baseline|Total|Total of all reporting groups
11375184|NCT02073565|FG000|Participant Flow|Combo|"The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.~OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface."
11375185|NCT02073565|FG001|Participant Flow|Everolimus Eluting Stent (EES)|"Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.~Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V."
11375186|NCT02073565|OG000|Outcome|Combo|"The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.~OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface."
11375187|NCT02073565|OG001|Outcome|Everolimus Eluting Stent (EES)|"Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.~Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V."
11375188|NCT02073565|EG000|Reported Event|Combo|"The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.~OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface."
11375189|NCT02073565|EG001|Reported Event|Everolimus Eluting Stent (EES)|"Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.~Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V."
11375190|NCT02060487|BG000|Baseline|Sildenafil 5 mg|Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11190988|NCT02129777|EG002|Reported Event|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11375191|NCT02060487|BG001|Baseline|Sildenafil 20 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375192|NCT02060487|BG002|Baseline|Sildenafil 80 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375193|NCT02060487|BG003|Baseline|Total|Total of all reporting groups
11375194|NCT02060487|FG000|Participant Flow|Sildenafil 5 mg|Participants received a single tablet of sildenafil at a dose of 5 milligram (mg) along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally thrice daily (TID) until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375195|NCT02060487|FG001|Participant Flow|Sildenafil 20 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375196|NCT02060487|FG002|Participant Flow|Sildenafil 80 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375197|NCT02060487|OG000|Outcome|Sildenafil 5 mg|Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375198|NCT02060487|OG001|Outcome|Sildenafil 20 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375199|NCT02060487|OG002|Outcome|Sildenafil 80 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375200|NCT02060487|EG000|Reported Event|Sildenafil 5 mg|Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375201|NCT02060487|EG001|Reported Event|Sildenafil 20 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375202|NCT02060487|EG002|Reported Event|Sildenafil 80 mg|Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
11375203|NCT00732212|BG000|Baseline|Standard Non-variceal Group|Standard non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
11375204|NCT00732212|BG001|Baseline|Doppler Non-variceal Group|Doppler non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
11375205|NCT00732212|BG002|Baseline|Standard Variceal Group|Standard variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
11375206|NCT00732212|BG003|Baseline|Doppler Variceal Group|Doppler variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
11375207|NCT00732212|BG004|Baseline|Total|Total of all reporting groups
11190989|NCT02129777|EG003|Reported Event|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190990|NCT02129777|EG004|Reported Event|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
11190991|NCT02129777|EG005|Reported Event|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
11190992|NCT02129777|EG006|Reported Event|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
11190993|NCT02129777|EG007|Reported Event|Follow-up Period: Placebo|Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
11190994|NCT02129777|EG008|Reported Event|Follow-up Period: Namilumab 20 mg|Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
11375208|NCT00732212|FG000|Participant Flow|Doppler Endoscopic Probe Assisted Hemostasis|"In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.~Doppler endoscopic ultrasound probe is used for blood flow detection"
11375209|NCT00732212|FG001|Participant Flow|Standard Endoscopic Hemostasis|"Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines~Standard endoscopic hemostasis: Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment."
11375210|NCT00732212|OG000|Outcome|Standard Non-variceal Group|30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
11375211|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|30 day rebleeding rate in Doppler assisted non-variceal patients.
11375212|NCT00732212|OG002|Outcome|Standard Variceal Group|30 day rebleeding rate in standard variceal visually guided hemostasis patients.
11375213|NCT00732212|OG003|Outcome|Doppler Variceal Group|30 day rebleeding rate in Doppler assisted variceal patients.
11375214|NCT00732212|OG000|Outcome|Standard Non-variceal Group|30 day rate of surgery in standard visually guided hemostasis non-variceal patients.
11375215|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|30 day rate of surgery in Doppler assisted non-variceal patients.
11375216|NCT00732212|OG002|Outcome|Standard Variceal Group|30 day rate of surgery in standard visually guided hemostasis variceal patients.
11375217|NCT00732212|OG003|Outcome|Doppler Variceal Group|30 day rate of surgery in Doppler assisted variceal patients.
11375218|NCT00732212|OG000|Outcome|Standard Non-variceal Group|Rate of standard visually guided hemostasis non-variceal patients who had complications within 30 days.
11375219|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|Rate of Doppler assisted non-variceal patients who had complications within 30 days.
11375220|NCT00732212|OG002|Outcome|Standard Variceal Group|Rate of standard visually guided hemostasis variceal patients who had complications within 30 days.
11375221|NCT00732212|OG003|Outcome|Doppler Variceal Patients|Rate of Doppler assisted variceal patients who had complications within 30 days.
11375222|NCT00732212|OG000|Outcome|Standard Non-variceal Group|Number of deaths in standard visually guided hemostasis non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
11375223|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|Number of deaths in Doppler assisted non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
11375224|NCT00732212|OG002|Outcome|Standard Variceal Group|Number of deaths in standard visually guided hemostasis variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
11375225|NCT00732212|OG003|Outcome|Doppler Variceal Group|Number of deaths in Doppler assisted variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
11375226|NCT00732212|OG000|Outcome|Standard Non-variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis non-variceal patients.
11375227|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|RBC units of transfusion post-randomization in Doppler assisted non-variceal patients.
11375228|NCT00732212|OG002|Outcome|Standard Variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis variceal patients.
11375229|NCT00732212|OG003|Outcome|Doppler Variceal Group|RBC units of transfusion post-randomization in Doppler assisted variceal patients.
11375230|NCT00732212|OG000|Outcome|Standard Non-variceal Group|Length of hospitalization days in standard visually guided hemostasis non-variceal patients.
11375231|NCT00732212|OG001|Outcome|Doppler Non-variceal Group|Length of hospitalization days in Doppler assisted non-variceal patients.
11375232|NCT00732212|OG002|Outcome|Standard Variceal Group|Length of hospitalization days in standard visually guided hemostasis variceal patients.
11375233|NCT00732212|OG003|Outcome|Doppler Variceal Group|Length of hospitalization days in Doppler assisted variceal patients.
11375234|NCT00732212|EG000|Reported Event|Standard Non-variceal Group|Serious adverse events in standard non-variceal visually guided hemostasis patients.
11375235|NCT00732212|EG001|Reported Event|Doppler Non-variceal Group|Serious adverse events in Doppler non-variceal patients.
11375236|NCT00732212|EG002|Reported Event|Standard Variceal Group|Serious adverse events in standard variceal visually guided hemostasis patients.
11375237|NCT00732212|EG003|Reported Event|Doppler Variceal Group|Serious adverse events in Doppler variceal visually guided hemostasis patients.
11375238|NCT00331773|BG000|Baseline|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
11375239|NCT00331773|BG001|Baseline|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
11375240|NCT00331773|BG002|Baseline|Total|Total of all reporting groups
11375241|NCT00331773|FG000|Participant Flow|Conventional 3D-CRT|Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
11375242|NCT00331773|FG001|Participant Flow|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
11375243|NCT00331773|OG000|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
11375244|NCT00331773|OG001|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
11375245|NCT00331773|OG000|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
11375246|NCT00331773|EG000|Reported Event|Conventional 3D-CRT|CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
11375247|NCT00331773|EG001|Reported Event|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
11375248|NCT00321698|BG000|Baseline|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375249|NCT00321698|BG001|Baseline|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375250|NCT00321698|BG002|Baseline|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375251|NCT00321698|BG003|Baseline|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375252|NCT00321698|BG004|Baseline|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375253|NCT00321698|BG005|Baseline|Total|Total of all reporting groups
11375254|NCT00321698|FG000|Participant Flow|Phase I, Radiation Only|"Group 1=radiation only;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375255|NCT00321698|FG001|Participant Flow|Phase I, Dose 1|"Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
11375256|NCT00321698|FG002|Participant Flow|Phase I, Dose 2|"Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
11375257|NCT00321698|FG003|Participant Flow|Phase I, Dose 3|"Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
11375258|NCT00321698|FG004|Participant Flow|Phase II, MTD Dose|"MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375259|NCT00321698|OG000|Outcome|Phase I Dose 1-4|"4 groups of men in phase I study.~Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation."
11375260|NCT00321698|OG000|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375261|NCT00321698|OG000|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
11375262|NCT00321698|OG000|Outcome|Phase I Dose 1-4|"Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375263|NCT00321698|OG001|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11190995|NCT02129777|EG009|Reported Event|Follow-up Period: Namilumab 50 mg|Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
11190996|NCT02129777|EG010|Reported Event|Follow-up Period: Namilumab 80 mg|Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
11190997|NCT02129777|EG011|Reported Event|Follow-up: Namilumab 150 mg|Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
11190998|NCT02129803|BG000|Baseline|Experimental Therapy|"High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air~High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2."
11375264|NCT00321698|EG000|Reported Event|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375265|NCT00321698|EG001|Reported Event|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375266|NCT00321698|EG002|Reported Event|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375267|NCT00321698|EG003|Reported Event|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11375268|NCT00321698|EG004|Reported Event|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
11376958|NCT01264679|OG000|Outcome|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
11376959|NCT01264679|OG000|Outcome|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose /dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
11376960|NCT01264679|EG000|Reported Event|Ferumoxytol|When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
11376961|NCT01155388|BG000|Baseline|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
11376962|NCT01155388|BG001|Baseline|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
11376963|NCT01155388|BG002|Baseline|Total|Total of all reporting groups
11376964|NCT01155388|FG000|Participant Flow|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
11376965|NCT01155388|FG001|Participant Flow|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
11376966|NCT01155388|OG000|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9"
11376967|NCT01155388|OG001|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
11376968|NCT01155388|OG000|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
11376969|NCT01155388|EG000|Reported Event|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
11376970|NCT01155388|EG001|Reported Event|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
11376971|NCT01137435|BG000|Baseline|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
11376972|NCT01137435|FG000|Participant Flow|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
11375269|NCT05343156|BG000|Baseline|DexNP Eye Drop|"The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375270|NCT05343156|BG001|Baseline|Vehicle Eye Drop|"The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375271|NCT05343156|BG002|Baseline|Total|Total of all reporting groups
11375272|NCT05343156|FG000|Participant Flow|DexNP Eye Drop|"The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375273|NCT05343156|FG001|Participant Flow|Vehicle Eye Drop|"The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375274|NCT05343156|OG000|Outcome|DexNP Eye Drop|"The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375275|NCT05343156|OG001|Outcome|Vehicle Eye Drop|"The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375276|NCT05343156|EG000|Reported Event|DexNP Eye Drop|"The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375277|NCT05343156|EG001|Reported Event|Vehicle Eye Drop|"The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.~Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks"
11375278|NCT04913636|BG000|Baseline|Test Group|Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
11375279|NCT04913636|BG001|Baseline|Control Group|Sham Control: Subjects will perform their regular denture cleaning routine.
11375280|NCT04913636|BG002|Baseline|Total|Total of all reporting groups
11375281|NCT04913636|FG000|Participant Flow|Test Group|Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
11375282|NCT04913636|FG001|Participant Flow|Control Group|Sham Control: Subjects will perform their regular denture cleaning routine.
11375283|NCT04913636|OG000|Outcome|Test Group|Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
11375284|NCT04913636|OG001|Outcome|Control Group|Sham Control: Subjects will perform their regular denture cleaning routine.
11375285|NCT04913636|EG000|Reported Event|Test Group|Treatment Gel: In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
11375286|NCT04913636|EG001|Reported Event|Control Group|Sham Control: Subjects will perform their regular denture cleaning routine.
11375287|NCT04882995|BG000|Baseline|Intervention - Received Fiber|Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
11375288|NCT04882995|BG001|Baseline|Control - Did Not Receive Fiber|Participants did not take any preoperative fiber.
11375289|NCT04882995|BG002|Baseline|Total|Total of all reporting groups
11375290|NCT04882995|FG000|Participant Flow|Intervention - Received Fiber|Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
11375291|NCT04882995|FG001|Participant Flow|Control - Did Not Receive Fiber|Participants did not take any preoperative fiber.
11375292|NCT04882995|OG000|Outcome|Intervention - Received Fiber|Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
11375293|NCT04882995|OG001|Outcome|Control - Did Not Receive Fiber|Participants did not take any preoperative fiber.
11375294|NCT04882995|EG000|Reported Event|Intervention - Received Fiber|Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
11375295|NCT04882995|EG001|Reported Event|Control - Did Not Receive Fiber|Participants did not take any preoperative fiber.
11375296|NCT04707573|BG000|Baseline|Cohort 1: CKD Stage 3 Vadadustat|Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375297|NCT04707573|BG001|Baseline|Cohort 2: CKD Stage 4 Vadadustat|Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375298|NCT04707573|BG002|Baseline|Total|Total of all reporting groups
11376973|NCT01137435|OG000|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
11190999|NCT02129803|BG001|Baseline|Control Therapy (Low Flow)|"Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air~Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air."
10962989|NCT00869401|OG000|Outcome|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
11191000|NCT02129803|BG002|Baseline|Total|Total of all reporting groups
11191001|NCT02129803|FG000|Participant Flow|Experimental Therapy|"High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air~High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2."
11191002|NCT02129803|FG001|Participant Flow|Control Therapy (Low Flow)|"Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air~Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air."
11191003|NCT02129803|OG000|Outcome|Experimental Therapy|"High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air~High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2."
11191004|NCT02129803|OG001|Outcome|Control Therapy (Low Flow)|"Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air~Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air."
11191005|NCT02129803|EG000|Reported Event|Experimental Therapy|"High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air~High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2."
11191006|NCT02129803|EG001|Reported Event|Control Therapy (Low Flow)|"Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air~Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air."
11191007|NCT02130024|BG000|Baseline|Ranibizumab 0.5 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191008|NCT02130024|BG001|Baseline|Aflibercept 2.0 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191009|NCT02130024|BG002|Baseline|Total|Total of all reporting groups
11191010|NCT02130024|FG000|Participant Flow|Ranibizumab 0.5 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191011|NCT02130024|FG001|Participant Flow|Aflibercept 2.0 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191012|NCT02130024|OG000|Outcome|Ranibizumab 0.5 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191013|NCT02130024|OG001|Outcome|Aflibercept 2.0 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191014|NCT02130024|EG000|Reported Event|Ranibizumab 0.5 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191015|NCT02130024|EG001|Reported Event|Aflibercept 2.0 mg|3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
11191016|NCT02130063|BG000|Baseline|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
11191017|NCT02130063|BG001|Baseline|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
11191018|NCT02130063|BG002|Baseline|Total|Total of all reporting groups
11191019|NCT02130063|FG000|Participant Flow|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
11375299|NCT04707573|FG000|Participant Flow|Cohort 1: CKD Stage 3 Vadadustat|Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 milliliter (mL)/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375300|NCT04707573|FG001|Participant Flow|Cohort 2: CKD Stage 4 Vadadustat|Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375301|NCT04707573|OG000|Outcome|Cohort 1: CKD Stage 3 Vadadustat|Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375302|NCT04707573|OG001|Outcome|Cohort 2: CKD Stage 4 Vadadustat|Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375303|NCT04707573|EG000|Reported Event|Cohort 1: CKD Stage 3 Vadadustat|Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375304|NCT04707573|EG001|Reported Event|Cohort 2: CKD Stage 4 Vadadustat|Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
11375305|NCT04640168|BG000|Baseline|Remdesivir Plus Baricitinib|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11375306|NCT04640168|BG001|Baseline|Remdesivir Plus Dexamethasone|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11375307|NCT04640168|BG002|Baseline|Total|Total of all reporting groups
11375308|NCT04640168|FG000|Participant Flow|Remdesivir Plus Baricitinib|"200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.~Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.~Placebo: Placebo matching intravenous dexamethasone.~Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
11375309|NCT04640168|FG001|Participant Flow|Remdesivir Plus Dexamethasone|"200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.~Dexamethasone: Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.~Placebo: Placebo matching oral baricitinib.~Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
11375310|NCT04640168|OG000|Outcome|Remdesivir Plus Baricitinib|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11375311|NCT04640168|OG001|Outcome|Remdesivir Plus Dexamethasone|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11375312|NCT04640168|EG000|Reported Event|Remdesivir Plus Baricitinib|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11375313|NCT04640168|EG001|Reported Event|Remdesivir Plus Dexamethasone|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
11191020|NCT02130063|FG001|Participant Flow|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
11191021|NCT02130063|OG000|Outcome|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
10962990|NCT00869401|OG001|Outcome|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
10962991|NCT00869401|OG002|Outcome|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
11191022|NCT02130063|OG001|Outcome|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
11191023|NCT02130063|EG000|Reported Event|Iron Isomaltoside 1000 (Monofer®)|"iron isomaltoside 1000 (Monofer®)~iron isomaltoside 1000 (Monofer®)"
11191024|NCT02130063|EG001|Reported Event|Iron Sucrose (Venofer®)|"iron sucrose (Venofer®)~iron sucrose (Venofer®)"
11191025|NCT02130193|BG000|Baseline|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191026|NCT02130193|BG001|Baseline|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191027|NCT02130193|BG002|Baseline|Total|Total of all reporting groups
11191028|NCT02130193|FG000|Participant Flow|Part A: 4-week Open-label Period: DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11375314|NCT04465630|BG000|Baseline|Pseudophakic Eyes With Open Angle Glaucoma|"Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.~OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System"
11375315|NCT04465630|FG000|Participant Flow|Pseudophakic Eyes With Open Angle Glaucoma|"One eye of each eligible subject enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.~OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System"
11375316|NCT04465630|OG000|Outcome|Pseudophakic Eyes With Open Angle Glaucoma|"One eye of each eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.~OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System"
11375317|NCT04465630|OG000|Outcome|Pseudophakic Eyes With Open Angle Glaucoma|"Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.~OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System"
11375318|NCT04465630|EG000|Reported Event|Pseudophakic Eyes With Open Angle Glaucoma|"Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.~OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System"
11375319|NCT04459598|BG000|Baseline|Efavirenz 600 mg + Quizartinib 60 mg|Participants who received efavirenz 600 mg once daily (QD) for 34 days and a single, oral dose of quizartinib 60 mg on Day 15 concurrently with efavirenz.
11375320|NCT04459598|BG001|Baseline|Quizartinib 60 mg|Participants who received a single, oral dose of quizartinib 60 mg on Day 1.
11375321|NCT04459598|BG002|Baseline|Total|Total of all reporting groups
11375322|NCT04459598|FG000|Participant Flow|Efavirenz 600 mg + Quizartinib 60 mg|Participants who received efavirenz 600 mg once daily (QD) for 34 days and a single, oral dose of quizartinib 60 mg on Day 15 concurrently with efavirenz.
11375323|NCT04459598|FG001|Participant Flow|Quizartinib 60 mg|Participants who received a single, oral dose of quizartinib 60 mg on Day 1.
11375324|NCT04459598|OG000|Outcome|Efavirenz 600 mg + Quizartinib 60 mg|Participants who received efavirenz 600 mg once daily (QD) for 34 days and a single, oral dose of quizartinib 60 mg on Day 15 concurrently with efavirenz.
11375325|NCT04459598|OG001|Outcome|Quizartinib 60 mg|Participants who received a single, oral dose of quizartinib 60 mg on Day 1.
11375326|NCT04459598|EG000|Reported Event|Efavirenz 600 mg + Quizartinib 60 mg|Participants who received efavirenz 600 mg once daily (QD) for 34 days and a single, oral dose of quizartinib 60 mg on Day 15 concurrently with efavirenz.
11375327|NCT04459598|EG001|Reported Event|Quizartinib 60 mg|Participants who received a single, oral dose of quizartinib 60 mg on Day 1.
11375328|NCT04439344|BG000|Baseline|Treatment (Binimetinib)|"Patients receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Binimetinib: Given PO"
11375329|NCT04439344|FG000|Participant Flow|Treatment (Binimetinib)|"Patients receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Binimetinib: Given PO"
11375330|NCT04439344|OG000|Outcome|Treatment (Binimetinib)|"Patients receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Binimetinib: Given PO"
11375331|NCT04439344|EG000|Reported Event|Treatment (Binimetinib)|"Patients receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Binimetinib: Given PO"
11375332|NCT04439279|BG000|Baseline|Subprotocol R|Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11375333|NCT04439279|FG000|Participant Flow|Subprotocol R|Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11375334|NCT04439279|OG000|Outcome|Subprotocol R|Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11375335|NCT04439279|EG000|Reported Event|Subprotocol R|Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11375336|NCT04439123|BG000|Baseline|Treatment (Capivasertib)|"Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Capivasertib: Given PO"
11375337|NCT04439123|FG000|Participant Flow|Treatment (Capivasertib)|"Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Capivasertib: Given PO"
11375338|NCT04439123|OG000|Outcome|Treatment (Capivasertib)|"Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Capivasertib: Given PO"
11375339|NCT04439123|EG000|Reported Event|Treatment (Capivasertib)|"Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Capivasertib: Given PO"
11376974|NCT01137435|EG000|Reported Event|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
11240594|NCT02480621|FG000|Participant Flow|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
11375340|NCT04439110|BG000|Baseline|Treatment (Trastuzumab Emtansine)|"Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Trastuzumab Emtansine: Given IV"
11375341|NCT04439110|FG000|Participant Flow|Treatment (Trastuzumab Emtansine)|"Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Trastuzumab Emtansine: Given IV"
11375342|NCT04439110|OG000|Outcome|Treatment (Trastuzumab Emtansine)|"Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Trastuzumab Emtansine: Given IV"
11375343|NCT04439110|EG000|Reported Event|Treatment (Trastuzumab Emtansine)|"Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Trastuzumab Emtansine: Given IV"
11375344|NCT04387136|BG000|Baseline|Sublingual Sufentanil|"Participants in this arm will receive the intervention.~Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider."
11375345|NCT04387136|BG001|Baseline|Control|Participants in this arm will not receive an intervention.
11375346|NCT04387136|BG002|Baseline|Total|Total of all reporting groups
11375347|NCT04387136|FG000|Participant Flow|Sublingual Sufentanil|"Participants in this arm will receive the intervention.~Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider."
11375348|NCT04387136|FG001|Participant Flow|Control|Participants in this arm will not receive an intervention.
11375349|NCT04387136|OG000|Outcome|Sublingual Sufentanil|"Participants in this arm will receive the intervention.~Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider."
11375350|NCT04387136|OG001|Outcome|Control|Participants in this arm will not receive an intervention.
11375351|NCT04387136|EG000|Reported Event|Sublingual Sufentanil|"Participants in this arm will receive the intervention.~Sublingual Sufentanil: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider."
11375352|NCT04387136|EG001|Reported Event|Control|Participants in this arm will not receive an intervention.
11375353|NCT04351269|BG000|Baseline|CanGaroo Envelope|"Patients who received a CanGaroo Envelope with their CIED implantation.~CanGaroo Envelope: CanGaroo Envelope with CIED implantation"
11375354|NCT04351269|BG001|Baseline|TYRX Envelope|"Patients who received a TYRX Envelope with their CIED implantation.~TYRX Envelope: TYRX Envelope with CIED implantation"
11375355|NCT04351269|BG002|Baseline|No Envelope|Patients who had their CIED implanted with no envelope.
11375356|NCT04351269|BG003|Baseline|Total|Total of all reporting groups
11375357|NCT04351269|FG000|Participant Flow|CanGaroo Envelope|"Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.~CanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation"
11375358|NCT04351269|FG001|Participant Flow|TYRX Envelope|"Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.~TYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation"
11375359|NCT04351269|FG002|Participant Flow|No Envelope|Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.
11375360|NCT04351269|OG000|Outcome|CanGaroo Envelope|"Patients who received a CanGaroo Envelope with their CIED implantation.~CanGaroo Envelope: CanGaroo Envelope with CIED implantation"
11375361|NCT04351269|OG001|Outcome|TYRX Envelope|"Patients who received a TYRX Envelope with their CIED implantation.~TYRX Envelope: TYRX Envelope with CIED implantation"
11375362|NCT04351269|OG002|Outcome|No Envelope|Patients who had their CIED implanted with no envelope.
11375363|NCT04351269|OG000|Outcome|CanGaroo Envelope|"Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.~CanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation"
11375364|NCT04351269|OG001|Outcome|TYRX Envelope|"Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.~TYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation"
11375365|NCT04351269|OG002|Outcome|No Envelope|Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.
11375366|NCT04351269|EG000|Reported Event|CanGaroo Envelope|"Patients who received a CanGaroo Envelope with their CIED implantation.~CanGaroo Envelope: CanGaroo Envelope with CIED implantation"
11375367|NCT04351269|EG001|Reported Event|TYRX Envelope|"Patients who received a TYRX Envelope with their CIED implantation.~TYRX Envelope: TYRX Envelope with CIED implantation"
11375368|NCT04351269|EG002|Reported Event|No Envelope|Patients who had their CIED implanted with no envelope.
11375369|NCT04292301|BG000|Baseline|STrategically Acquired Gradient Echo (STAGE)|"STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.~STrategically Acquired Gradient Echo (STAGE): The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired."
11376975|NCT01095003|BG000|Baseline|Capecitabine Single-agent|Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
11376976|NCT01095003|BG001|Baseline|Vinflunine Plus Capecitabine|"Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks~Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11240595|NCT02480621|FG001|Participant Flow|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
11191029|NCT02130193|FG001|Participant Flow|Part B: 52-week Double-blind Period: Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11375370|NCT04292301|FG000|Participant Flow|STrategically Acquired Gradient Echo (STAGE)|"STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.~STrategically Acquired Gradient Echo (STAGE): The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired."
11375371|NCT04292301|OG000|Outcome|STrategically Acquired Gradient Echo (STAGE)|"STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.~STrategically Acquired Gradient Echo (STAGE): The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired."
11375372|NCT04292301|EG000|Reported Event|STrategically Acquired Gradient Echo (STAGE)|"STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.~STrategically Acquired Gradient Echo (STAGE): The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired."
11375373|NCT04285229|BG000|Baseline|Placebo|Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
11375374|NCT04285229|BG001|Baseline|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
11375375|NCT04285229|BG002|Baseline|Total|Total of all reporting groups
11375376|NCT04285229|FG000|Participant Flow|Placebo|Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
11375377|NCT04285229|FG001|Participant Flow|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
11375378|NCT04285229|OG000|Outcome|Placebo|Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
11375379|NCT04285229|OG001|Outcome|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
11375380|NCT04285229|OG000|Outcome|Placebo|Participants received placebo every four weeks (Q4W) by subcutaneous (SC)injection.
11375381|NCT04285229|OG000|Outcome|Placebo|Participants received placebo every four weeks (Q4W) by subcutaneous (SC)injection during.
11375382|NCT04285229|OG000|Outcome|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
11375383|NCT04285229|EG000|Reported Event|Placebo|Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection.
11375384|NCT04285229|EG001|Reported Event|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
11375385|NCT04148521|BG000|Baseline|Behavioral Health - Virtual Patient Navigation|"All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.~Behavioral Health - Virtual Patient Navigation: Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention."
11375386|NCT04148521|BG001|Baseline|Usual Care Behavioral Health|All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.
11375387|NCT04148521|BG002|Baseline|Total|Total of all reporting groups
11375388|NCT04148521|FG000|Participant Flow|Behavioral Health - Virtual Patient Navigation|"All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.~Behavioral Health - Virtual Patient Navigation: Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention."
11375389|NCT04148521|FG001|Participant Flow|Usual Care Behavioral Health|All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.
11376977|NCT01095003|BG002|Baseline|Total|Total of all reporting groups
10962992|NCT00869401|EG000|Reported Event|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
10962993|NCT00869401|EG001|Reported Event|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib100 mg/day until progression.
10962994|NCT00869401|EG002|Reported Event|Dose Level 1 Phase1|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962995|NCT00869401|EG003|Reported Event|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
10962996|NCT00869401|EG004|Reported Event|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
10962997|NCT00869440|BG000|Baseline|1: CNS 7056 0.10 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10962998|NCT00869440|BG001|Baseline|2: CNS 7056 0.15 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10962999|NCT00869440|BG002|Baseline|3: CNS 7056 0.20 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
11191030|NCT02130193|FG002|Participant Flow|Part B: 52-week Double-blind Period: DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
10963000|NCT00869440|BG003|Baseline|4: Midazolam 0.075 mg/kg|Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
10963001|NCT00869440|BG004|Baseline|Total|Total of all reporting groups
10963002|NCT00869440|FG000|Participant Flow|1: CNS 7056 0.10 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963003|NCT00869440|FG001|Participant Flow|2: CNS 7056 0.15 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963004|NCT00869440|FG002|Participant Flow|3: CNS 7056 0.20 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
11191031|NCT02130193|OG000|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11240596|NCT02480621|OG000|Outcome|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
10963005|NCT00869440|FG003|Participant Flow|4: Midazolam 0.075 mg/kg|Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
10963006|NCT00869440|OG000|Outcome|1: CNS 7056 0.10 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963007|NCT00869440|OG001|Outcome|2: CNS 7056 0.15 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963008|NCT00869440|OG002|Outcome|3: CNS 7056 0.20 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963009|NCT00869440|OG003|Outcome|4: Midazolam 0.075 mg/kg|Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
10963010|NCT00869440|EG000|Reported Event|1: CNS 7056 0.10 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
10963011|NCT00869440|EG001|Reported Event|2: CNS 7056 0.15 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
11240597|NCT02480621|OG001|Outcome|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
10963012|NCT00869440|EG002|Reported Event|3: CNS 7056 0.20 mg/kg|CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
11240598|NCT02480621|EG000|Reported Event|Control|Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia
11191032|NCT02130193|OG000|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11376978|NCT01095003|FG000|Participant Flow|Vinflunine Plus Capecitabine|"Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks~Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11191033|NCT02130193|OG001|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191034|NCT02130193|OG000|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191035|NCT02130193|EG000|Reported Event|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191036|NCT02130193|EG001|Reported Event|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191037|NCT02130193|EG002|Reported Event|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant's current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
11191038|NCT02130258|BG000|Baseline|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
11191039|NCT02130258|BG001|Baseline|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
11191040|NCT02130258|BG002|Baseline|Total|Total of all reporting groups
11191041|NCT02130258|FG000|Participant Flow|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
11191042|NCT02130258|FG001|Participant Flow|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
11191043|NCT02130258|OG000|Outcome|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
11191044|NCT02130258|OG001|Outcome|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
11191045|NCT02130258|EG000|Reported Event|>30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
11191814|NCT02134184|FG002|Participant Flow|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the recent timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past"
10963013|NCT00869440|EG003|Reported Event|4: Midazolam 0.075 mg/kg|Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
11375390|NCT04148521|OG000|Outcome|Behavioral Health - Virtual Patient Navigation|"All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.~Behavioral Health - Virtual Patient Navigation: Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention."
11375391|NCT04148521|OG001|Outcome|Usual Care Behavioral Health|All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.
11375392|NCT04148521|EG000|Reported Event|Behavioral Health - Virtual Patient Navigation|"All patients who meet eligibility criteria at sites where the virtual patient navigation behavioral health program is offered will be considered exposed to the intervention.~Behavioral Health - Virtual Patient Navigation: Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention."
11375393|NCT04148521|EG001|Reported Event|Usual Care Behavioral Health|All patients who meet eligibility criteria at sites where the virtual patient navigator behavioral health program is not offered will be considered exposed to usual care.
11375394|NCT03897348|BG000|Baseline|Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg|"Participant received single dose of placebo in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg.~(2) 200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.~(3) Placebo. A single dose is given at the beginning of 1 of 3 ADP sessions.~Lacosamide: Oral medication Placebo: Oral medication"
11375395|NCT03897348|BG001|Baseline|Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo|Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 100 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo.
11375396|NCT03897348|BG002|Baseline|Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg|Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of placebo. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg.
11375397|NCT03897348|BG003|Baseline|Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo|Participant received a single dose of lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo.
11375398|NCT03897348|BG004|Baseline|Total|Total of all reporting groups
11375399|NCT03897348|FG000|Participant Flow|Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg|Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
11375400|NCT03897348|FG001|Participant Flow|Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo|Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
11375401|NCT03897348|FG002|Participant Flow|Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg|Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg
11375402|NCT03897348|FG003|Participant Flow|Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo|Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
11375403|NCT03897348|OG000|Outcome|Total|Total of all reporting groups
11375404|NCT03897348|OG000|Outcome|Placebo|"A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Placebo: Oral medication"
11375405|NCT03897348|OG001|Outcome|Lacosamide 100 mg|"100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Lacosamide: Oral medication"
11375406|NCT03897348|OG002|Outcome|Lacosamide 200 mg|"200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Lacosamide: Oral medication"
11191815|NCT02134184|OG000|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11375407|NCT03897348|EG000|Reported Event|Placebo|"A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Placebo: Oral medication"
11375408|NCT03897348|EG001|Reported Event|Lacosamide 100 mg|"100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Lacosamide: Oral medication"
11375409|NCT03897348|EG002|Reported Event|Lacosamide 200 mg|"200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.~Lacosamide: Oral medication"
11375410|NCT03682601|BG000|Baseline|Placebo|"15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~Placebo: Aquaphor/vehicle"
11375411|NCT03682601|BG001|Baseline|5% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily."
11375412|NCT03682601|BG002|Baseline|10% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily."
11375413|NCT03682601|BG003|Baseline|Total|Total of all reporting groups
11375414|NCT03682601|FG000|Participant Flow|Placebo|"15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~Placebo: Aquaphor/vehicle"
11375415|NCT03682601|FG001|Participant Flow|5% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily."
11375416|NCT03682601|FG002|Participant Flow|10% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily."
11376979|NCT01095003|FG001|Participant Flow|Capecitabine Single-agent|Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
11191816|NCT02134184|OG001|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11191817|NCT02134184|OG002|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
10963014|NCT00869518|BG000|Baseline|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963015|NCT00869518|BG001|Baseline|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963016|NCT00869518|BG002|Baseline|Total|Total of all reporting groups
10963017|NCT00869518|FG000|Participant Flow|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
11375417|NCT03682601|OG000|Outcome|Placebo|"15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~Placebo: Aquaphor/vehicle"
11375418|NCT03682601|OG001|Outcome|5% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily."
11375419|NCT03682601|OG002|Outcome|10% Topical Sinecatechins Ointment|"15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily."
11375420|NCT03682601|OG000|Outcome|Placebo|"12 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~Placebo: Aquaphor/vehicle"
11375421|NCT03682601|OG001|Outcome|5% Topical Sinecatechins Ointment|"7 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily."
11375422|NCT03682601|OG002|Outcome|10% Topical Sinecatechins Ointment|"13 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily."
11375423|NCT03682601|EG000|Reported Event|Placebo|"12 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~Placebo: Aquaphor/vehicle"
11376980|NCT01095003|OG000|Outcome|Vinflunine Plus Capecitabine|"Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks~Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11375424|NCT03682601|EG001|Reported Event|5% Topical Sinecatechins Ointment|"7 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily."
11375425|NCT03682601|EG002|Reported Event|10% Topical Sinecatechins Ointment|"13 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.~They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).~A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.~The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.~10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily."
11375426|NCT03668808|BG000|Baseline|All Study Participants|"Subjects with type 1 diabetes and on multiple daily injections will use either basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN or they will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to these arms first or second.~For Insulin Glargine: Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec.~For Insulin Degludec: Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine."
11375427|NCT03668808|FG000|Participant Flow|Insulin Degludec, Then Insulin Glargine|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.~Insulin Degludec: Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine."
11375428|NCT03668808|FG001|Participant Flow|Insulin Glargine U100, Then Insulin Degludec|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.~Insulin Glargine: Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec."
11375429|NCT03668808|OG000|Outcome|Insulin Degludec|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.~Insulin Degludec: Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~TRESIBA® FLEXTOUCH®: Subjects will use Tresiba FlexTouch pens when using Tresiba as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight."
11375430|NCT03668808|OG001|Outcome|Insulin Glargine U100|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.~Insulin Glargine: Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~LANTUS® SOLOSTAR® INSULIN PEN: Subjects will use Lantus SoloStar insulin pens when using Lantus as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight."
11375431|NCT03668808|OG000|Outcome|Sleep at Each Destination|Sleep quantity at each destination, either New York or Hawaii.
11375432|NCT03668808|OG000|Outcome|Sleep at Each Destination|Sleep quality/efficiency at each destination, either New York or Hawaii.
11375433|NCT03668808|EG000|Reported Event|Insulin Degludec, Then Insulin Glargine|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.~Insulin Degludec: Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine."
11375434|NCT03668808|EG001|Reported Event|Insulin Glargine U100, Then Insulin Degludec|"Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.~Insulin Glargine: Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.~After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec."
11376981|NCT01095003|OG001|Outcome|Capecitabine Single-agent|Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
10963018|NCT00869518|FG001|Participant Flow|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963019|NCT00869518|OG000|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963020|NCT00869518|OG001|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963021|NCT00869518|EG000|Reported Event|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
10963022|NCT00869518|EG001|Reported Event|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
11191046|NCT02130258|EG001|Reported Event|<30% Pain Relief|All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
11191047|NCT02130284|BG000|Baseline|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
11191048|NCT02130284|FG000|Participant Flow|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
11191049|NCT02130284|OG000|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
11191050|NCT02130284|EG000|Reported Event|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
11191051|NCT02130297|BG000|Baseline|Participants With Fitzpatrick Skin Phototype I or II|Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
11191052|NCT02130297|FG000|Participant Flow|Participants With Fitzpatrick Skin Phototype I or II|Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
11375435|NCT03658642|BG000|Baseline|Clinical Decision Support for BUP|"The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score >12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.~Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)"
11375436|NCT03658642|BG001|Baseline|Usual Care|The CDS will not be activated and patients will receive care as usual.
11375437|NCT03658642|BG002|Baseline|Total|Total of all reporting groups
11375438|NCT03658642|FG000|Participant Flow|Clinical Decision Support for BUP|"The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score >12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.~Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)"
11375439|NCT03658642|FG001|Participant Flow|Usual Care|The CDS will not be activated and patients will receive care as usual.
11375440|NCT03658642|OG000|Outcome|Clinical Decision Support for BUP|"The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score >12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.~Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)"
11375441|NCT03658642|OG001|Outcome|Usual Care|The CDS will not be activated and patients will receive care as usual.
11375442|NCT03658642|EG000|Reported Event|Clinical Decision Support for BUP|"The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score >12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.~Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)"
11375443|NCT03658642|EG001|Reported Event|Usual Care|The CDS will not be activated and patients will receive care as usual.
11375444|NCT03656874|BG000|Baseline|Usual Care|Usual care, practitioners review clinical guidelines for tobacco during consent process.
11375445|NCT03656874|BG001|Baseline|Clinical Decision Support|Clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
11375446|NCT03656874|BG002|Baseline|Total|Total of all reporting groups
10963023|NCT00869557|BG000|Baseline|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
11375447|NCT03656874|FG000|Participant Flow|Usual Care|Usual care, practitioners review clinical guidelines for tobacco during consent process.
11375448|NCT03656874|FG001|Participant Flow|Clinical Decision Support|Clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
11375449|NCT03656874|OG000|Outcome|Usual Care|Usual care, practitioners review clinical guidelines for tobacco during consent process.
11375450|NCT03656874|OG001|Outcome|Clinical Decision Support|Clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
11375451|NCT03656874|EG000|Reported Event|Usual Care|Usual care, practitioners review clinical guidelines for tobacco during consent process.
11375452|NCT03656874|EG001|Reported Event|Clinical Decision Support|The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
11375453|NCT03584009|BG000|Baseline|Venetoclax + Fulvestrant|Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375454|NCT03584009|BG001|Baseline|Fulvestrant|Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375455|NCT03584009|BG002|Baseline|Total|Total of all reporting groups
11375456|NCT03584009|FG000|Participant Flow|Venetoclax + Fulvestrant|Participants were administered Venetoclax 800mg orally once daily (QD) and Fulvestrant 500mg intramuscularly (IM) on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375457|NCT03584009|FG001|Participant Flow|Fulvestrant|Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375458|NCT03584009|OG000|Outcome|Venetoclax + Fulvestrant|Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375459|NCT03584009|OG001|Outcome|Fulvestrant|Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375460|NCT03584009|OG000|Outcome|Venetoclax|Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375461|NCT03584009|OG000|Outcome|Fulvestrant|Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days)
11375462|NCT03584009|OG000|Outcome|Fulvestrant|Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
10963024|NCT00869557|BG001|Baseline|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
10963025|NCT00869557|BG002|Baseline|Total|Total of all reporting groups
11375463|NCT03584009|EG000|Reported Event|Venetoclax + Fulvestrant|Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375464|NCT03584009|EG001|Reported Event|Fulvestrant|Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).
11375465|NCT03583359|BG000|Baseline|Treatment With Radiesse (+)|Right and left jawline injected with Radiesse (+).
11375466|NCT03583359|BG001|Baseline|Control/Delayed Treatment With Radiesse (+)|Participants did not receive treatment for the first 12 weeks.
11375467|NCT03583359|BG002|Baseline|Total|Total of all reporting groups
11375468|NCT03583359|FG000|Participant Flow|Treatment With Radiesse (+)|Right and left jawline injected with Radiesse (+).
11375469|NCT03583359|FG001|Participant Flow|Control/Delayed Treatment With Radiesse (+)|Participants did not receive treatment for the first 12 weeks.
11375470|NCT03583359|OG000|Outcome|Treatment With Radiesse (+)|Right and left jawline injected with Radiesse (+).
11375471|NCT03583359|OG001|Outcome|Control/Delayed Treatment With Radiesse (+)|Participants did not receive treatment for the first 12 weeks.
11375472|NCT03583359|EG000|Reported Event|Treatment With Radiesse (+)|Right and left jawline injected with Radiesse (+).
11375473|NCT03583359|EG001|Reported Event|Control/Delayed Treatment With Radiesse (+)|Participants did not receive treatment for the first 12 weeks.
11375474|NCT03568162|BG000|Baseline|ISB 830 300 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375475|NCT03568162|BG001|Baseline|ISB 830 300 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375476|NCT03568162|BG002|Baseline|ISB 830 75 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375477|NCT03568162|BG003|Baseline|Placebo - 1|"Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375478|NCT03568162|BG004|Baseline|ISB 830 600 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375479|NCT03568162|BG005|Baseline|Placebo - 2|"Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375480|NCT03568162|BG006|Baseline|Total|Total of all reporting groups
11375481|NCT03568162|FG000|Participant Flow|ISB 830 300 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375482|NCT03568162|FG001|Participant Flow|ISB 830 300 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375483|NCT03568162|FG002|Participant Flow|ISB 830 75 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375484|NCT03568162|FG003|Participant Flow|Placebo - 1|"Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375485|NCT03568162|FG004|Participant Flow|ISB 830 600 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375486|NCT03568162|FG005|Participant Flow|Placebo - 2|"Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375487|NCT03568162|OG000|Outcome|ISB 830 300 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375488|NCT03568162|OG001|Outcome|ISB 830 300 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375489|NCT03568162|OG002|Outcome|ISB 830 75 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375490|NCT03568162|OG003|Outcome|Placebo - 1|"Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375491|NCT03568162|OG004|Outcome|ISB 830 600 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375492|NCT03568162|OG005|Outcome|Placebo - 2|"Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375493|NCT03568162|OG003|Outcome|ISB 830 600 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11191053|NCT02130297|OG000|Outcome|Participants With Fitzpatrick Skin Phototype I or II|Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
10963026|NCT00869557|FG000|Participant Flow|Stribild|Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
10963027|NCT00869557|FG001|Participant Flow|Atripla|Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
10963028|NCT00869557|OG000|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
10963029|NCT00869557|OG001|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
10963030|NCT00869557|EG000|Reported Event|Stribild|Stribild and placebo to match Atripla were administered during the double-blind phase.
10963031|NCT00869557|EG001|Reported Event|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
11375494|NCT03568162|EG000|Reported Event|ISB 830 300 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 2 weeks (q2w) starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375495|NCT03568162|EG001|Reported Event|ISB 830 300 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 600 mg via SC injection (2 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection every 4 weeks (q4w) starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375496|NCT03568162|EG002|Reported Event|ISB 830 75 mg q4w|"Blinded Treatment Phase: ISB 830 administered at dose of 150 mg via SC injection (2 × 75 mg) on Day 1, followed by ISB 830 administered at dose of 75 mg (1 × 75 mg) via SC injection q4w starting from Day 29 (Week 4) up to Week 12 and placebo administered via SC injection q4w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375497|NCT03568162|EG003|Reported Event|Placebo - 1 (Blinded)|Blinded Treatment Phase: Placebo administered via SC injection (2 injections) q2w starting from Day 1 up to Week 14.
11375498|NCT03568162|EG004|Reported Event|Placebo - 1 (Open Label)|Open-label Treatment Phase: ISB 830 administered at dose of 300 mg (1 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
11375499|NCT03568162|EG005|Reported Event|ISB 830 600 mg q2w|"Blinded Treatment Phase: ISB 830 administered at dose of 1200 mg via SC injection (4 × 300 mg) on Day 1, followed by ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Day 15 (Week 2) up to Week 14.~Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66."
11375500|NCT03568162|EG006|Reported Event|Placebo - 2 (Blinded)|Blinded Treatment Phase: Placebo administered via SC injection (4 injections) q2w starting from Day 1 up to Week 14.
11375501|NCT03568162|EG007|Reported Event|Placebo - 2 (Open Label)|Open-label Treatment Phase: ISB 830 administered at dose of 600 mg (2 × 300 mg) via SC injection q2w starting from Week 16 up to Week 52 (or until participant withdrawal). Participants were followed up for 12 weeks after treatment discontinuation, maximum up to Week 66.
11375502|NCT03557307|BG000|Baseline|Benra 30 mg|Benralizumab 30 mg administered subcutaneously every 4 weeks
11375503|NCT03557307|FG000|Participant Flow|Benra 30 mg|Benralizumab 30 mg administered subcutaneously every 4 weeks
11375504|NCT03557307|OG000|Outcome|Benra 30 mg|Benralizumab 30 mg administered subcutaneously every 4 weeks
11375505|NCT03557307|EG000|Reported Event|Benra 30 mg|Benralizumab 30 mg administered subcutaneously every 4 weeks
11375506|NCT03492463|BG000|Baseline|Nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375507|NCT03492463|BG001|Baseline|Non-nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375508|NCT03492463|BG002|Baseline|Nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375509|NCT03492463|BG003|Baseline|Non-nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375510|NCT03492463|BG004|Baseline|Total|Total of all reporting groups
11375511|NCT03492463|FG000|Participant Flow|Nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375512|NCT03492463|FG001|Participant Flow|Non-nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375513|NCT03492463|FG002|Participant Flow|Nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375514|NCT03492463|FG003|Participant Flow|Non-nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375515|NCT03492463|OG000|Outcome|Nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375516|NCT03492463|OG001|Outcome|Non-nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375517|NCT03492463|OG002|Outcome|Nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375518|NCT03492463|OG003|Outcome|Non-nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375519|NCT03492463|EG000|Reported Event|Nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375520|NCT03492463|EG001|Reported Event|Non-nicotine E-cigs + Nicotine Patches|"Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375521|NCT03492463|EG002|Reported Event|Nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375522|NCT03492463|EG003|Reported Event|Non-nicotine E-cigs + Placebo Patches|"Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.~Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.~Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks."
11375523|NCT03417687|BG000|Baseline|129Xe Before 133Xe|"Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375524|NCT03417687|BG001|Baseline|133Xe Before 129Xe|"Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375525|NCT03417687|BG002|Baseline|Total|Total of all reporting groups
11375526|NCT03417687|FG000|Participant Flow|129Xe Before 133Xe|"Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375527|NCT03417687|FG001|Participant Flow|133Xe Before 129Xe|"Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375528|NCT03417687|OG000|Outcome|129Xe MRI|All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
11240599|NCT02480621|EG001|Reported Event|Liposomal Bupivacaine With Bupivacaine|"Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.~Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle."
11240600|NCT02480712|BG000|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11375529|NCT03417687|OG001|Outcome|133Xe|All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
11375530|NCT03417687|OG000|Outcome|129Xe MRI|Subjects receiving 129Xe MRI. All subjects received 129Xe MRI and 133Xe scintigraphy in randomized order.
11375531|NCT03417687|OG001|Outcome|133Xe Scintigraphy|Subjects receiving 133Xe scintigraphy. All subjects received 129Xe MRI and 133Xe scintigraphy in randomized order.
11375532|NCT03417687|OG000|Outcome|129Xe MRI|All subjects receiving 129Xe MRI. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
11375533|NCT03417687|OG001|Outcome|133Xe Scintigraphy|All subjects receiving 133Xe scintigraphy. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
11375534|NCT03417687|OG000|Outcome|129Xe MRI|Subjects receiving 129Xe MRI. All subjects received 129Xe MRI and 133 Xe scintigraphy in randomized order.
11375535|NCT03417687|OG001|Outcome|133Xe Scintigraphy|Subjects receiving 133Xe scintigraphy. All subjects received 129Xe MRI and 133 Xe scintigraphy in randomized order.
11375536|NCT03417687|OG001|Outcome|Arm 2|"Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375537|NCT03417687|OG001|Outcome|133 Xe Scintigraphy|Subjects receiving 133Xe scintigraphy. All subjects received 129Xe MRI and 133Xe scintigraphy in randomized order.
11375538|NCT03417687|EG000|Reported Event|129Xe Before 133Xe|"Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375539|NCT03417687|EG001|Reported Event|133Xe Before 129Xe|"Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI~129Xe MRI: Evaluation of pulmonary function~133 Xe scintigraphy: Evaluation of pulmonary function"
11375540|NCT03402230|BG000|Baseline|Avmacol|Participants who initiated Avmacol intervention
11375541|NCT03402230|FG000|Participant Flow|Avmacol Low Dose First, Then High Dose|Participants received lower dose of Avmacol daily for 10-14 days, followed by 10-14 days of washout, and followed by higher dose of Avmacol daily for 10-14 days.
11375542|NCT03402230|FG001|Participant Flow|Avmacol High Dose First, Then Low Dose|Participants received higher dose of Avmacol daily for 10-14 days, followed by 10-14 days of washout, and followed by lower dose of Avmacol daily for 10-14 days.
11375543|NCT03402230|OG000|Outcome|Avmacol|Participants who initiated Avmacol intervention
11375544|NCT03402230|EG000|Reported Event|High Dose|8 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
11375545|NCT03402230|EG001|Reported Event|Low Dose|4 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
11375546|NCT03379675|BG000|Baseline|Treatment A: JNJ-53718678 500 mg|Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.
11375547|NCT03379675|BG001|Baseline|Treatment B: JNJ-53718678 80 mg + Placebo|Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding.
11375548|NCT03379675|BG002|Baseline|Treatment C: Placebo|Participants received matching placebo as an oral solution once daily for 7 days.
11375549|NCT03379675|BG003|Baseline|Total|Total of all reporting groups
11375550|NCT03379675|FG000|Participant Flow|Treatment A: JNJ-53718678 500 mg|Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.
11375551|NCT03379675|FG001|Participant Flow|Treatment B: JNJ-53718678 80 mg + Placebo|Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding.
11375552|NCT03379675|FG002|Participant Flow|Treatment C: Placebo|Participants received matching placebo as an oral solution once daily for 7 days.
11375553|NCT03379675|OG000|Outcome|Treatment A: JNJ-53718678 500 mg|Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.
11375554|NCT03379675|OG001|Outcome|Treatment B: JNJ-53718678 80 mg + Placebo|Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding.
11375555|NCT03379675|OG002|Outcome|Treatment C: Placebo|Participants received matching placebo as an oral solution once daily for 7 days.
11375556|NCT03379675|EG000|Reported Event|Treatment A: JNJ-53718678 500 mg|Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.
11375557|NCT03379675|EG001|Reported Event|Treatment B: JNJ-53718678 80 mg + Placebo|Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding.
11375558|NCT03379675|EG002|Reported Event|Treatment C: Placebo|Participants received matching placebo as an oral solution once daily for 7 days.
11375559|NCT03373435|BG000|Baseline|Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD)|"Placebo, exendin 9-39 30 mg BID, exendin 9-39 60 mg QD~exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.~Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39."
11375560|NCT03373435|BG001|Baseline|Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID)|"Placebo, exendin 9-39 60 mg QD, exendin 9-39 30 mg BID~exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.~Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39."
11375561|NCT03373435|BG002|Baseline|Total|Total of all reporting groups
11375562|NCT03373435|FG000|Participant Flow|Treatment Group 1|"Placebo, exendin 9-39 30 mg BID, exendin 9-39 60 mg QD~exendin 9-39: Exendin 9-39 is a competitive antagonist of glucagon-like peptide-1 (GLP-1) at its receptor.~Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39."
11375563|NCT03373435|FG001|Participant Flow|Treatment Group 2|"Placebo, exendin 9-39 60 mg QD, exendin 9-39 30 mg BID~exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.~Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39."
11375564|NCT03373435|OG000|Outcome|Avexitide 30 mg BID|patients (treatment group 1 + treatment 2) received 30 mg twice a day
11375565|NCT03373435|OG001|Outcome|Avexitide 60 mg QD|patients (treatment group 1 + treatment group 2)) receive 60 mg once a day.
11375566|NCT03373435|OG002|Outcome|Placebo|Patients received placebo in treatment period 1 (initial 14 days) in the study.
11375567|NCT03373435|EG000|Reported Event|Avexitide 30 mg BID|patients (treatment group 1 + treatment 2) received 30 mg twice a day
11375568|NCT03373435|EG001|Reported Event|Avexitide 60 mg QD|patients (treatment group 1 + treatment group 2)) received 60 mg once a day.
11375569|NCT03373435|EG002|Reported Event|Placebo|Patients received placebo in treatment period 1 (initial 14 days) in the study.
11375570|NCT03336619|BG000|Baseline|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
11375571|NCT03336619|BG001|Baseline|Placebo|Two Placebo tablets orally twice daily (b.i.d.) for 5 days
11375572|NCT03336619|BG002|Baseline|Total|Total of all reporting groups
11375573|NCT03336619|FG000|Participant Flow|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
11375574|NCT03336619|FG001|Participant Flow|Placebo|Two Placebo tablets orally twice daily (b.i.d.) for 5 days
11375575|NCT03336619|OG000|Outcome|Nitazoxanide|Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
11375576|NCT03336619|OG001|Outcome|Placebo|Two Placebo tablets orally twice daily (b.i.d.) for 5 days
11375577|NCT03336619|OG000|Outcome|ITTI Population|The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline.
11375578|NCT03336619|OG000|Outcome|Placebo-Treated Subjects With Detectable Antibodies at Baseline|Subjects with laboratory-confirmed influenza (ITTI population) randomized to receive placebo who had anti-influenza antibodies detected in a Baseline serum sample.
11375579|NCT03336619|OG001|Outcome|Placebo-Treated Subjects Without Detectable Antibodies at Baseline|Subjects with laboratory-confirmed influenza (ITTI population) randomized to receive placebo who had no anti-influenza antibodies detected in a Baseline serum sample.
11375580|NCT03336619|EG000|Reported Event|Nitazoxanide|"Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days~Nitazoxanide: Nitazoxanide 600 mg administered orally twice daily for five days"
11375581|NCT03336619|EG001|Reported Event|Placebo|"Two Placebo tablets orally twice daily (b.i.d.) for 5 days~Placebo: Placebo administered orally twice daily for five days"
11375582|NCT03274687|BG000|Baseline|Conventional Radiation Therapy|"Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375583|NCT03274687|BG001|Baseline|Hypofractionated Radiation Therapy|"Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375584|NCT03274687|BG002|Baseline|Total|Total of all reporting groups
11375585|NCT03274687|FG000|Participant Flow|Conventional Radiation Therapy|"Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy (ADT): Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375586|NCT03274687|FG001|Participant Flow|Hypofractionated Radiation Therapy|"Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375587|NCT03274687|OG000|Outcome|Conventional Radiation Therapy|"Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11376982|NCT01095003|OG000|Outcome|Vinflunine Plus Capecitabine|"Patients received (in combination with capecitabine)~• Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.~Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks~Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11375588|NCT03274687|OG001|Outcome|Hypofractionated Radiation Therapy|"Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375589|NCT03274687|EG000|Reported Event|Conventional Radiation Therapy|"Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375590|NCT03274687|EG001|Reported Event|Hypofractionated Radiation Therapy|"Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.~Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.~Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed."
11375591|NCT03245450|BG000|Baseline|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375592|NCT03245450|BG001|Baseline|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375593|NCT03245450|BG002|Baseline|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 100 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375594|NCT03245450|BG003|Baseline|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 125 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375595|NCT03245450|BG004|Baseline|Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with RMS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375596|NCT03245450|BG005|Baseline|Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with NRSTS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375597|NCT03245450|BG006|Baseline|Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with EWS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375598|NCT03245450|BG007|Baseline|Total|Total of all reporting groups
11375599|NCT03245450|FG000|Participant Flow|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 (milligram per square meter) intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375600|NCT03245450|FG001|Participant Flow|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375601|NCT03245450|FG002|Participant Flow|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 100 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375602|NCT03245450|FG003|Participant Flow|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 125 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375603|NCT03245450|FG004|Participant Flow|Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with RMS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11191054|NCT02130297|EG000|Reported Event|Participants With Fitzpatrick Skin Phototype I or II|Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
10963032|NCT00869557|EG002|Reported Event|All Stribild|The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.
11191055|NCT02130427|BG000|Baseline|Imaging|Weekly 3D/4D CT scans; MRI scans used at the discretion of the treating physician when the location of the tumor requires it.
11191056|NCT02130427|FG000|Participant Flow|Imaging|Weekly 3D/4D CT scans while receiving radiation therapy. Radiation therapy dosage metrics were not collected.
11375604|NCT03245450|FG005|Participant Flow|Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with NRSTS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375605|NCT03245450|FG006|Participant Flow|Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with EWS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375606|NCT03245450|OG000|Outcome|Phase 1: All Participants|All participants received eribulin mesilate 1.4 mg/m^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m^2 or 40 mg/m^2 intravenous infusion on Days 1 to 5 (schedule A) and irinotecan hydrochloride 100 mg/m^2 or 125 mg/m^2 intravenous infusion on Days 1 and 8 (schedule B) in 21-day treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375607|NCT03245450|OG000|Outcome|Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with RMS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375608|NCT03245450|OG001|Outcome|Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with NRSTS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375609|NCT03245450|OG002|Outcome|Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with EWS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375610|NCT03245450|OG000|Outcome|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375611|NCT03245450|OG001|Outcome|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375612|NCT03245450|OG002|Outcome|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 100 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375613|NCT03245450|OG003|Outcome|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 125 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375614|NCT03245450|OG004|Outcome|Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with RMS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375615|NCT03245450|OG005|Outcome|Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with NRSTS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375616|NCT03245450|OG006|Outcome|Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with EWS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375617|NCT03245450|OG000|Outcome|Eribulin Mesilate - All Participants|All participants who received eribulin mesilate intravenous infusion over the dose range 0.25 to 4.0 mg/m^2 in current study (E7389-G000-213) and studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885).
11375618|NCT03245450|OG000|Outcome|Eribulin Mesilate - All Participants|All participants who received eribulin mesilate intravenous infusion over the dose range 0.25 to 4.0 mg/m^2 in current study (E7389-G000-213) and in studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885).
11375619|NCT03245450|EG000|Reported Event|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375620|NCT03245450|EG001|Reported Event|Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375621|NCT03245450|EG002|Reported Event|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 100 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375622|NCT03245450|EG003|Reported Event|Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2|Participants received eribulin mesilate 1.4 mg/m^2 and irinotecan hydrochloride 125 mg/m^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375623|NCT03245450|EG004|Reported Event|Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with RMS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
11375624|NCT03245450|EG005|Reported Event|Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with NRSTS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375625|NCT03245450|EG006|Reported Event|Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2|Participants with EWS received eribulin mesilate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
11375626|NCT03086369|BG000|Baseline|Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375627|NCT03086369|BG001|Baseline|Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375628|NCT03086369|BG002|Baseline|Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|"Following a protocol amendment, cohort expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met."
11375629|NCT03086369|BG003|Baseline|Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375630|NCT03086369|BG004|Baseline|Phase 2: Placebo + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375631|NCT03086369|BG005|Baseline|Total|Total of all reporting groups
11375632|NCT03086369|FG000|Participant Flow|Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375633|NCT03086369|FG001|Participant Flow|Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375634|NCT03086369|FG002|Participant Flow|Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|"Following a protocol amendment, cohort expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met."
11375635|NCT03086369|FG003|Participant Flow|Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375636|NCT03086369|FG004|Participant Flow|Phase 2: Placebo + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375637|NCT03086369|OG000|Outcome|Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375638|NCT03086369|OG001|Outcome|Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375639|NCT03086369|OG002|Outcome|Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|"Following a protocol amendment, cohort expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met."
11191057|NCT02130427|OG000|Outcome|Completed Imaging|"Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician.~CT scan: Weekly 3D/4D CT scan"
11191058|NCT02130427|EG000|Reported Event|Complete Imaging|"Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician.~CT scan: Weekly 3D/4D CT scan"
11191059|NCT02130557|BG000|Baseline|Bosutinib|Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191060|NCT02130557|BG001|Baseline|Imatinib|Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11375640|NCT03086369|OG000|Outcome|Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375641|NCT03086369|OG001|Outcome|Phase 2: Placebo + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375642|NCT03086369|OG003|Outcome|Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375643|NCT03086369|OG004|Outcome|Phase 2: Placebo + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375644|NCT03086369|EG000|Reported Event|Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375645|NCT03086369|EG001|Reported Event|Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375646|NCT03086369|EG002|Reported Event|Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine|"Following a protocol amendment, cohort expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met."
11375647|NCT03086369|EG003|Reported Event|Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375648|NCT03086369|EG004|Reported Event|Phase 2: Placebo + Nab-paclitaxel + Gemcitabine|Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
11375649|NCT03083808|BG000|Baseline|Pembrolizumab 200mg IV Every 21 Days|"Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.~Pembrolizumab: Pembrolizumab 200mg IV every 21 days~+~Physician's choice chemotherapy with one of the following every 21 days:~Docetaxel 75mg/m2 IV~Pemetrexed 500mg/m2 IV (non-squamous only)~Gemcitabine 1000mg/m2 IV on days 1 and 8"
11375650|NCT03083808|FG000|Participant Flow|Pembrolizumab 200mg IV Every 21 Days|"Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.~Pembrolizumab: Pembrolizumab 200mg IV every 21 days~+~Physician's choice chemotherapy with one of the following every 21 days:~Docetaxel 75mg/m2 IV~Pemetrexed 500mg/m2 IV (non-squamous only)~Gemcitabine 1000mg/m2 IV on days 1 and 8"
11375651|NCT03083808|OG000|Outcome|Pembrolizumab 200mg IV Every 21 Days|"Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.~Pembrolizumab: Pembrolizumab 200mg IV every 21 days~+~Physician's choice chemotherapy with one of the following every 21 days:~Docetaxel 75mg/m2 IV~Pemetrexed 500mg/m2 IV (non-squamous only)~Gemcitabine 1000mg/m2 IV on days 1 and 8"
11376983|NCT01095003|OG001|Outcome|Capecitabine Single-agent|"Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).~Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11376984|NCT01095003|EG000|Reported Event|Vinflunine Plus Capecitabine|"Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks~Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
11191061|NCT02130557|BG002|Baseline|Total|Total of all reporting groups
11191818|NCT02134184|EG000|Reported Event|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11191819|NCT02134184|EG001|Reported Event|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
10963971|NCT00875277|FG000|Participant Flow|All Randomized Participants|All randomized participants received the six investigational medicinal products on six different test sites. LEO 29102 cream, LEO 29102 plus calcipotriol cream, LEO 29102 plus betamethasone dipropionate cream, Daivobet® ointment, Betamethasone dipropionate cream, and LEO 29102 cream vehicle applied topically once daily six times a week for 4 weeks (not on Sundays) on six different 2-cm diameter site (one per study preparation).
11375652|NCT03083808|EG000|Reported Event|Pembrolizumab 200mg IV Every 21 Days|"Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.~Pembrolizumab: Pembrolizumab 200mg IV every 21 days~+~Physician's choice chemotherapy with one of the following every 21 days:~Docetaxel 75mg/m2 IV~Pemetrexed 500mg/m2 IV (non-squamous only)~Gemcitabine 1000mg/m2 IV on days 1 and 8"
11375653|NCT02951767|BG000|Baseline|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
11375654|NCT02951767|FG000|Participant Flow|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 milligrams (mg) via intravenous (IV) on Day 1 of 21-day cycles until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria or unmanageable toxicity.
11375655|NCT02951767|OG000|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
11375656|NCT02951767|EG000|Reported Event|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
11375657|NCT02927847|BG000|Baseline|BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts."
11375658|NCT02927847|BG001|Baseline|VLNC (Very Low Nicotine Cigarettes) Only|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation."
11375659|NCT02927847|BG002|Baseline|Total|Total of all reporting groups
11375660|NCT02927847|FG000|Participant Flow|BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts."
11376985|NCT01095003|EG001|Reported Event|Capecitabine Single-agent|Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
11376986|NCT01064817|BG000|Baseline|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11191820|NCT02134184|EG002|Reported Event|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
11191821|NCT02134210|BG000|Baseline|Enbrel (Etanercept)|"Enbrel 50mg twice weekly times 12 weeks~Etanercept: Head-to-head comparison"
11191822|NCT02134210|BG001|Baseline|CHS-0214|"CHS-0214 50mg twice weekly times 12 weeks~CHS-0214"
10963972|NCT00875277|OG000|Outcome|LEO 29102 Cream Vehicle|LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
10963973|NCT00875277|OG001|Outcome|Betamethasone Dipropionate Cream|Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
10963974|NCT00875277|OG002|Outcome|LEO 29102 Cream|LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
11191823|NCT02134210|BG002|Baseline|Total|Total of all reporting groups
10963033|NCT00869609|BG000|Baseline|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963975|NCT00875277|OG003|Outcome|LEO 29102 Plus Calcipotriol Cream|LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
11240601|NCT02480712|FG000|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11376987|NCT01064817|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
10963976|NCT00875277|OG004|Outcome|LEO 29102 Plus Betamethasone Dipropionate|LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
11376988|NCT01064817|BG002|Baseline|Total|Total of all reporting groups
11376989|NCT01064817|FG000|Participant Flow|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11375661|NCT02927847|FG001|Participant Flow|VLNC (Very Low Nicotine Cigarettes) Only|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation."
11375662|NCT02927847|OG000|Outcome|BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts."
11375663|NCT02927847|OG001|Outcome|VLNC (Very Low Nicotine Cigarettes) Only|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation."
11375664|NCT02927847|EG000|Reported Event|BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts."
11375665|NCT02927847|EG001|Reported Event|VLNC (Very Low Nicotine Cigarettes) Only|"Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).~SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.~Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation."
11375666|NCT02903355|BG000|Baseline|Placebo|"Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.~Placebo: Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met."
11375667|NCT02903355|BG001|Baseline|D-methionine, Oral Liquid Suspension|"D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.~D-methionine: D-methionine, oral liquid suspension"
11375668|NCT02903355|BG002|Baseline|Total|Total of all reporting groups
11191824|NCT02134210|FG000|Participant Flow|Enbrel (Etanercept)|"Enbrel 50mg twice weekly times 12 weeks~Etanercept: Head-to-head comparison"
11191825|NCT02134210|FG001|Participant Flow|CHS-0214|"CHS-0214 50mg twice weekly times 12 weeks~CHS-0214"
11191826|NCT02134210|OG000|Outcome|Enbrel (Etanercept)|"Enbrel 50mg twice weekly times 12 weeks~Etanercept: Head-to-head comparison"
11191827|NCT02134210|OG001|Outcome|CHS-0214|"CHS-0214 50mg twice weekly times 12 weeks~CHS-0214"
10963034|NCT00869609|BG001|Baseline|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963035|NCT00869609|BG002|Baseline|Total|Total of all reporting groups
11375669|NCT02903355|FG000|Participant Flow|Placebo|"Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.~Placebo: Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met."
11240602|NCT02480712|OG000|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11376990|NCT01064817|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11191828|NCT02134210|EG000|Reported Event|Enbrel (Etanercept)|"Enbrel 50mg twice weekly times 12 weeks~Etanercept: Head-to-head comparison"
11191829|NCT02134210|EG001|Reported Event|CHS-0214|"CHS-0214 50mg twice weekly times 12 weeks~CHS-0214"
11191062|NCT02130557|FG000|Participant Flow|Bosutinib|Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) received bosutinib tablets at a dose of 400 milligram (mg), orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191063|NCT02130557|FG001|Participant Flow|Imatinib|Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191064|NCT02130557|OG000|Outcome|Bosutinib|Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191065|NCT02130557|OG001|Outcome|Imatinib|Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191066|NCT02130557|EG000|Reported Event|Bosutinib|Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
11191067|NCT02130557|EG001|Reported Event|Imatinib|Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
10963977|NCT00875277|OG005|Outcome|Daivobet® Ointment|Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
11191068|NCT02130570|BG000|Baseline|Multi-Model Intensive Discharge Program|"Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient discharge advocate 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:~Home pharmacist visit~Enrollment in the Partners integrated Care Management Program (iCMP)~Enrollment in telemedicine programs for patients with CHF~Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information"
11191069|NCT02130570|BG001|Baseline|Usual Care|Patients receive the same care they would normally receive.
11191070|NCT02130570|BG002|Baseline|Total|Total of all reporting groups
11191071|NCT02130570|FG000|Participant Flow|Multi-Model Intensive Discharge Program|"Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient discharge advocate 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:~Home pharmacist visit~Enrollment in the Partners integrated Care Management Program (iCMP)~Enrollment in telemedicine programs for patients with CHF~Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information"
11191072|NCT02130570|FG001|Participant Flow|Usual Care|Patients receive the care that they would normally receive.
11191073|NCT02130570|OG000|Outcome|Multi-Model Intensive Discharge Program|"Multi-Model Intensive Discharge Program~Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient discharge advocate 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:~Home pharmacist visit~Enrollment in the Partners integrated Care Management Program (iCMP)~Enrollment in telemedicine programs for patients with CHF~Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information"
11191074|NCT02130570|OG001|Outcome|Usual Care|Patients receive the care they would normally receive.
11191075|NCT02130570|OG000|Outcome|Multi-Model Intensive Discharge Program|"Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient discharge advocate 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:~Home pharmacist visit~Enrollment in the Partners integrated Care Management Program (iCMP)~Enrollment in telemedicine programs for patients with CHF~Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information"
11191076|NCT02130570|EG000|Reported Event|Multi-Model Intensive Discharge Program|"Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient discharge advocate 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed:~Home pharmacist visit~Enrollment in the Partners integrated Care Management Program (iCMP)~Enrollment in telemedicine programs for patients with CHF~Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information"
11191077|NCT02130570|EG001|Reported Event|Usual Care|Patients receive the care they would normally receive.
11191078|NCT02130583|BG000|Baseline|Positive Affect Skills Training|"Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend.~Positive Affect Skills Training: Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend."
10963978|NCT00875277|OG003|Outcome|LEO 29102 Plus Calcipotriol Cream|LEO 29102 2.5 mg/g plus calcipotriol 50 mcg/g cream applied topically twice daily for 4 weeks.
11191079|NCT02130583|BG001|Baseline|Treatment as Usual|"Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend.~Treatment as Usual: Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend."
11191080|NCT02130583|BG002|Baseline|Total|Total of all reporting groups
11191081|NCT02130583|FG000|Participant Flow|Positive Affect Skills Training|"Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend.~Positive Affect Skills Training: Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend."
11191082|NCT02130583|FG001|Participant Flow|Treatment as Usual|"Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend.~Treatment as Usual: Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend."
11191083|NCT02130583|OG000|Outcome|STEP|Study Intervention: Skills to Enhance Positivity
11191084|NCT02130583|OG001|Outcome|ETAU|Enhanced Treatment as Usual: Healthy Habits Text Messages
11191085|NCT02130583|EG000|Reported Event|Positive Affect Skills Training|"Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend.~Positive Affect Skills Training: Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend."
11191830|NCT02134314|BG000|Baseline|C1-Inhibitor (Berinert) (Human) (C1INH)|"35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11375670|NCT02903355|FG001|Participant Flow|D-methionine, Oral Liquid Suspension|"D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.~D-methionine: D-methionine, oral liquid suspension"
11375671|NCT02903355|OG000|Outcome|Placebo|"Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.~Placebo: Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met."
11375672|NCT02903355|OG001|Outcome|D-methionine, Oral Liquid Suspension|"D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.~D-methionine: D-methionine, oral liquid suspension"
11375673|NCT02903355|EG000|Reported Event|Placebo|"Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.~Placebo: Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met."
11375674|NCT02903355|EG001|Reported Event|D-methionine, Oral Liquid Suspension|"D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.~D-methionine: D-methionine, oral liquid suspension"
11375675|NCT02892149|BG000|Baseline|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11375676|NCT02892149|BG001|Baseline|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11375677|NCT02892149|BG002|Baseline|Total|Total of all reporting groups
11375678|NCT02892149|FG000|Participant Flow|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11375679|NCT02892149|FG001|Participant Flow|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11375680|NCT02892149|OG000|Outcome|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11375681|NCT02892149|OG001|Outcome|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11375682|NCT02892149|EG000|Reported Event|Vadadustat|Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
11375683|NCT02892149|EG001|Reported Event|Darbepoetin Alfa|Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
11375684|NCT02872116|BG000|Baseline|Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)|"Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks~Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks"
11375685|NCT02872116|BG001|Baseline|Arm 2: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
11375686|NCT02872116|BG002|Baseline|Arm 3: Nivolumab + Ipilimumab|1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
11240603|NCT02480712|OG000|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group.
11375687|NCT02872116|BG003|Baseline|Total|Total of all reporting groups
11375688|NCT02872116|FG000|Participant Flow|Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)|"Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks~Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks"
11375689|NCT02872116|FG001|Participant Flow|Arm 2: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
11375690|NCT02872116|FG002|Participant Flow|Arm 3: Nivolumab + Ipilimumab|1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
11375691|NCT02872116|OG000|Outcome|Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)|"Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks~Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks"
11375692|NCT02872116|OG001|Outcome|Arm 2a: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
11375693|NCT02872116|OG001|Outcome|Arm 2a: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 1.
11375694|NCT02872116|OG002|Outcome|Arm 2b: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 3.
11375695|NCT02872116|OG003|Outcome|Arm 3: Nivolumab + Ipilimumab|1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
11375696|NCT02872116|OG000|Outcome|Arm 2b: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 3.
11375697|NCT02872116|OG001|Outcome|Arm 3: Nivolumab + Ipilimumab|1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
11375698|NCT02872116|EG000|Reported Event|Arm A: Nivolumab + Chemotherapy (XELOX or FOLFOX)|"Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks~Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks"
11376991|NCT01064817|OG000|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11375699|NCT02872116|EG001|Reported Event|Arm B: Chemotherapy (XELOX or FOLFOX)|Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
11375700|NCT02872116|EG002|Reported Event|Arm C: Nivolumab + Ipilimumab|1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
11375701|NCT02870920|BG000|Baseline|Best Supportive Care|"Best supportive care available~Best Supportive Care"
11375702|NCT02870920|BG001|Baseline|Durvalumab Plus Tremelimumab and Best Supportive Care|"Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care~Tremelimumab~Durvalumab~Best Supportive Care"
11375703|NCT02870920|BG002|Baseline|Total|Total of all reporting groups
11375704|NCT02870920|FG000|Participant Flow|Best Supportive Care|"Best supportive care available~Best Supportive Care"
11375705|NCT02870920|FG001|Participant Flow|Durvalumab Plus Tremelimumab and Best Supportive Care|"Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care~Tremelimumab~Durvalumab~Best Supportive Care"
11375706|NCT02870920|OG000|Outcome|Best Supportive Care|"Best supportive care available~Best Supportive Care"
11375707|NCT02870920|OG001|Outcome|Durvalumab Plus Tremelimumab and Best Supportive Care|"Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care~Tremelimumab~Durvalumab~Best Supportive Care"
11375708|NCT02870920|EG000|Reported Event|Best Supportive Care|"Best supportive care available~Best Supportive Care"
11375709|NCT02870920|EG001|Reported Event|Durvalumab Plus Tremelimumab and Best Supportive Care|"Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care~Tremelimumab~Durvalumab~Best Supportive Care"
11375710|NCT02720523|BG000|Baseline|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
11375711|NCT02720523|BG001|Baseline|Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
11375712|NCT02720523|BG002|Baseline|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
11375713|NCT02720523|BG003|Baseline|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
11375714|NCT02720523|BG004|Baseline|Total|Total of all reporting groups
11375715|NCT02720523|FG000|Participant Flow|Period 1: Placebo|Participants randomized to receive placebo once daily (QD) for 12 weeks in Period 1.
11375716|NCT02720523|FG001|Participant Flow|Period 1: Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
11375717|NCT02720523|FG002|Participant Flow|Period 1: Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
11375718|NCT02720523|FG003|Participant Flow|Period 1: Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
11375719|NCT02720523|FG004|Participant Flow|Period 2: Upadacitinib 7.5 mg|Participants received upadacitinib 7.5 mg QD from Week 12 to Week 260 during the long-term extension period.
11375720|NCT02720523|FG005|Participant Flow|Period 2: Upadacitinib 15 mg|Participants received upadacitinib 15 mg QD from Week 12 to Week 260 during the long-term extension period.
11375721|NCT02720523|FG006|Participant Flow|Period 2: Upadacitinib 30 mg|Participants received upadacitinib 30 mg QD from Week 12 to Week 260 during the long-term extension period.
11375722|NCT02720523|OG000|Outcome|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
11375723|NCT02720523|OG001|Outcome|Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
11375724|NCT02720523|OG002|Outcome|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
11375725|NCT02720523|OG003|Outcome|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
11375726|NCT02720523|EG000|Reported Event|Period 1: Placebo|Participants received placebo once daily for 12 weeks in Period 1.
11375727|NCT02720523|EG001|Reported Event|Period 1: Upadacitinib 7.5 mg|Participants received upadacitinib 7.5 mg once daily for 12 weeks in Period 1
11375728|NCT02720523|EG002|Reported Event|Period 1: Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1
11375729|NCT02720523|EG003|Reported Event|Period 1: Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
11375730|NCT02720523|EG004|Reported Event|Period 1+2: Upadacitinib 7.5 mg|Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 7.5 mg from Week 12 to Week 60.
11375731|NCT02720523|EG005|Reported Event|Period 1+2: Upadacitinib 15 mg|Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 15 mg from Week 12 to Week 60.
11375732|NCT02720523|EG006|Reported Event|Period 1+2: Upadacitinib 30 mg|Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 30 mg from Week 12 to Week 60.
11191086|NCT02130583|EG001|Reported Event|Treatment as Usual|"Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend.~Treatment as Usual: Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend."
11191087|NCT02130635|BG000|Baseline|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
11375733|NCT02625324|BG000|Baseline|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
11375734|NCT02625324|FG000|Participant Flow|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
11375735|NCT02625324|OG000|Outcome|Endovascular Repair|"Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).~Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS)."
11375736|NCT02625324|OG000|Outcome|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 87 subjects (53 US, 47 OUS).
11375737|NCT02625324|OG000|Outcome|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
11375738|NCT02625324|OG000|Outcome|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
11375739|NCT02625324|EG000|Reported Event|Endovascular Repair 30-Day Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.~For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval."
11375740|NCT02625324|EG001|Reported Event|Endovascular Repair 6-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.~For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval."
11375741|NCT02625324|EG002|Reported Event|Endovascular Repair 12-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.~For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval."
11375742|NCT02625324|EG003|Reported Event|Endovascular Repair 24-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.~For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval."
11375743|NCT02625324|EG004|Reported Event|Endovascular Repair 36-Month Secondary|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days.~For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval."
11375744|NCT02581930|BG000|Baseline|Treatment (Ibrutinib)|"Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Pharmacological Study: Correlative studies"
11376992|NCT01064817|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11191088|NCT02130635|BG001|Baseline|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
11191089|NCT02130635|BG002|Baseline|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
11375745|NCT02581930|FG000|Participant Flow|Treatment (Ibrutinib)|"Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Pharmacological Study: Correlative studies"
11375746|NCT02581930|OG000|Outcome|Treatment (Ibrutinib)|"Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Pharmacological Study: Correlative studies"
11375747|NCT02581930|EG000|Reported Event|Treatment (Ibrutinib)|"Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies~Pharmacological Study: Correlative studies"
11375748|NCT02581137|BG000|Baseline|Prevention (Extended-release Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO"
11375749|NCT02581137|FG000|Participant Flow|Prevention (Extended-release Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO"
11375750|NCT02581137|OG000|Outcome|Prevention (Extended-release Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO"
11375751|NCT02581137|EG000|Reported Event|Prevention (Extended-release Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO"
11375752|NCT02568566|BG000|Baseline|Prevention (Gardasil 9)|"Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).~Laboratory Biomarker Analysis: Correlative studies~Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM"
11375753|NCT02568566|FG000|Participant Flow|Prevention (Gardasil 9)|"Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).~Laboratory Biomarker Analysis: Correlative studies~Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM"
11375754|NCT02568566|OG000|Outcome|Prevention (Gardasil 9)|"Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).~Laboratory Biomarker Analysis: Correlative studies~Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM"
11375755|NCT02568566|EG000|Reported Event|Prevention (Gardasil 9)|"Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).~Laboratory Biomarker Analysis: Correlative studies~Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM"
11375756|NCT02550652|BG000|Baseline|OBINUTUZUMAB 1000MG and MMF|Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375757|NCT02550652|BG001|Baseline|PLACEBO and MMF|Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375758|NCT02550652|BG002|Baseline|Total|Total of all reporting groups
11375759|NCT02550652|FG000|Participant Flow|OBINUTUZUMAB 1000MG and MMF|Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11376993|NCT01064817|EG000|Reported Event|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11376994|NCT01064817|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
11376995|NCT01026220|BG000|Baseline|INDUCTION THERAPY (ABVE-PC)|All Patients
11376996|NCT01026220|FG000|Participant Flow|INDUCTION THERAPY (ABVE-PC)|All Patients
10963979|NCT00875277|OG000|Outcome|LEO 29102 Cream Vehicle|LEO 29102 cream vehicle without any active substance applied topically twice daily for 4 weeks.
10963980|NCT00875277|EG000|Reported Event|All Randomized Participants|All randomized participants received the six products on six different test sites.
11376997|NCT01026220|FG001|Participant Flow|REGIMEN I (RER)|Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
10963981|NCT00875329|BG000|Baseline|Group 1|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
11375760|NCT02550652|FG001|Participant Flow|PLACEBO and MMF|Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375761|NCT02550652|OG000|Outcome|OBINUTUZUMAB 1000MG and MMF|Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375762|NCT02550652|OG001|Outcome|PLACEBO and MMF|Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375763|NCT02550652|EG000|Reported Event|OBINUTUZUMAB 1000MG and MMF|Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375764|NCT02550652|EG001|Reported Event|PLACEBO and MMF|Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
11375765|NCT02498600|BG000|Baseline|Treatment 1|"Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 4 weeks"
11375766|NCT02498600|BG001|Baseline|Treatment II|"Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 3 weeks for induction phase~1 Cycle = 4 weeks for maintenance phase"
11375767|NCT02498600|BG002|Baseline|Total|Total of all reporting groups
11375768|NCT02498600|FG000|Participant Flow|Treatment 1|"Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 4 weeks"
11375769|NCT02498600|FG001|Participant Flow|Treatment II|"Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 3 weeks for induction phase~1 Cycle = 4 weeks for maintenance phase"
11375770|NCT02498600|OG000|Outcome|Treatment 1|"Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 4 weeks"
11375771|NCT02498600|OG001|Outcome|Treatment II|"Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 3 weeks for induction phase~1 Cycle = 4 weeks for maintenance phase"
11375772|NCT02498600|EG000|Reported Event|Treatment 1|"Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 4 weeks"
11375773|NCT02498600|EG001|Reported Event|Treatment II|"Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.~1 Cycle = 3 weeks for induction phase~1 Cycle = 4 weeks for maintenance phase"
11375774|NCT02468778|BG000|Baseline|HeartMate PHP (Roll-in)|"Participants who receive a HeartMate PHP device without randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375775|NCT02468778|BG001|Baseline|HeartMate PHP (Randomised)|"Participants who receive a HeartMate PHP device after randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375776|NCT02468778|BG002|Baseline|Any Abiomed Impella® (Randomised)|"Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm~Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI."
11375777|NCT02468778|BG003|Baseline|Total|Total of all reporting groups
11375778|NCT02468778|FG000|Participant Flow|HeartMate PHP (Roll-in)|"Participants who receive a HeartMate PHP device without randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375779|NCT02468778|FG001|Participant Flow|HeartMate PHP (Randomised)|"Participants who receive a HeartMate PHP device after randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375780|NCT02468778|FG002|Participant Flow|Any Abiomed Impella® (Randomised)|"Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm~Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI."
11375781|NCT02468778|OG000|Outcome|HeartMate PHP (Roll-in)|"Participants who receive a HeartMate PHP device without randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375782|NCT02468778|OG001|Outcome|HeartMate PHP (Randomised)|"Participants who receive a HeartMate PHP device after randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375783|NCT02468778|OG002|Outcome|Any Abiomed Impella® (Randomised)|"Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm~Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI."
11375784|NCT02468778|EG000|Reported Event|HeartMate PHP (Roll-in)|"Participants who receive a HeartMate PHP device without randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375785|NCT02468778|EG001|Reported Event|HeartMate PHP (Randomised)|"Participants who receive a HeartMate PHP device after randomisation will be included in this arm~HeartMate PHP: The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events."
11375786|NCT02468778|EG002|Reported Event|Any Abiomed Impella® (Randomised)|"Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm~Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI."
11375787|NCT02435849|BG000|Baseline|Single Dose of CTL019|Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
11375788|NCT02435849|FG000|Participant Flow|Single Dose of CTL019|Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
11375789|NCT02435849|OG000|Outcome|Single Dose of CTL019|Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
11375790|NCT02435849|EG000|Reported Event|Single Dose of CTL019|Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisageneceucel
11375791|NCT02432274|BG000|Baseline|Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2|Participants (age group 2 to <6 years and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to <6 years first underwent 21-days run-in period with lenvatinib 5 mg/m^2, once daily before receiving lenvatinib 11 mg/m^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
11375792|NCT02432274|BG001|Baseline|Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2|Participants (age group 2 to <6 years and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to <6 years first underwent 21-days run-in period with lenvatinib 5 mg/m^2, once daily before receiving lenvatinib 14 mg/m^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
11375793|NCT02432274|BG002|Baseline|Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2|Participants (of age group 6 to <18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
11375794|NCT02432274|BG003|Baseline|Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2|Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
11376998|NCT01026220|FG002|Participant Flow|REGIMEN II (SER)|Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
11376999|NCT01026220|OG000|Outcome|Group 1|All Patients
11377000|NCT01026220|OG000|Outcome|Group 2|Regimen 1
11191090|NCT02130635|BG003|Baseline|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11375795|NCT02432274|BG004|Baseline|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375796|NCT02432274|BG005|Baseline|Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
11375797|NCT02432274|BG006|Baseline|Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
11375798|NCT02432274|BG007|Baseline|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375799|NCT02432274|BG008|Baseline|Total|Total of all reporting groups
11375800|NCT02432274|FG000|Participant Flow|Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2|Participants(age group 2 to<6 years and 6 to<18 years)with relapsed or refractory solid malignant tumors received lenvatinib 11mg/m^2(per BSA, daily dose capped at 24 milligram per day[mg/day])as capsules or suspension(lenvatinib capsules dissolved in water/apple juice for participants who were unable to swallow capsules and given as suspension),orally,once daily on Days 1 to 28 of each treatment cycle until progressive disease(PD),intolerable toxicity,participant noncompliance with safety/efficacy assessments,initiation of another anticancer therapy,voluntary discontinuation by participant at any time,or study termination by sponsor,whichever occurred first. Eligible participants of age group 2 to<6 years first underwent 21days run-in period with lenvatinib 5mg/m^2,once daily before receiving lenvatinib11 mg/m^2 in Cycle1 in Cohort1. Duration of each treatment cycle in Cohort1=28 days.After determining recommended dose(RD)in Cohort1,participants were enrolled in Cohorts 2A,2B and 3A.
11375801|NCT02432274|FG001|Participant Flow|Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2|Participants (age group 2 to <6 years and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to <6 years first underwent 21-days run-in period with lenvatinib 5 mg/m^2, once daily before receiving lenvatinib 14 mg/m^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
11375802|NCT02432274|FG002|Participant Flow|Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2|Participants (of age group 6 to <18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
11377001|NCT01026220|OG001|Outcome|Group 3|Regimen II
10963982|NCT00875329|FG000|Participant Flow|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
11377002|NCT01026220|OG001|Outcome|Group 4|RER PET-1 positive
11377003|NCT01026220|OG002|Outcome|Group 5|RER PET-1 negative
11377004|NCT01026220|OG001|Outcome|Group 6|risk-adapted radiation therapy
11377005|NCT01026220|OG002|Outcome|Group 7|no risk-adapted radiation therapy
11377006|NCT01026220|OG000|Outcome|Group 2|Regimen I
11377007|NCT01026220|OG001|Outcome|Group 2|Regimen I
11377008|NCT01026220|OG002|Outcome|Group 3|Regimen II
11377009|NCT01026220|EG000|Reported Event|Group 1|All Patients
10963983|NCT00875329|OG000|Outcome|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
11240604|NCT02480712|OG001|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
11240605|NCT02480712|OG002|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
11377010|NCT01026220|EG001|Reported Event|Group 2|Regimen I
10963984|NCT00875329|EG000|Reported Event|Convenience Sample|A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
11377011|NCT01026220|EG002|Reported Event|Group 3|Regimen II
10963985|NCT00875342|BG000|Baseline|D-cycloserine|DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
10963986|NCT00875342|BG001|Baseline|Placebo|Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
10963987|NCT00875342|BG002|Baseline|Total|Total of all reporting groups
11375803|NCT02432274|FG003|Participant Flow|Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2|Participants with 131 iodine-refractory differentiated thyroid cancer (DTC) received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
11375804|NCT02432274|FG004|Participant Flow|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375805|NCT02432274|FG005|Participant Flow|Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20 percent [%] lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 milligram per square meter per day (mg/m^2/day) intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
11375806|NCT02432274|FG006|Participant Flow|Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
11375807|NCT02432274|FG007|Participant Flow|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375808|NCT02432274|OG000|Outcome|Cohort 1: All Participants|Participants (of age group 2 to <6 years [following the completion of run-in period] and 6 to <18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m^2, 14 mg/m^2 or 17 mg/m^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375809|NCT02432274|OG000|Outcome|Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2|Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
11375810|NCT02432274|OG000|Outcome|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375811|NCT02432274|OG001|Outcome|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375812|NCT02432274|OG000|Outcome|Cohort 3A: All Participants|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20% lower than the RD from Cohort 1) or 14 mg/m^2, administered per BSA with daily dose capped at 24 mg/day as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle, in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375813|NCT02432274|OG000|Outcome|Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2|Participants (age group 2 to <6 years [following completion of run-in period] and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375814|NCT02432274|OG001|Outcome|Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2|Participants (age group 2 to <6 years [following completion of run-in period] and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375815|NCT02432274|OG002|Outcome|Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2|Participants (of age group 6 to <18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375816|NCT02432274|OG003|Outcome|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375817|NCT02432274|OG004|Outcome|Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375818|NCT02432274|OG005|Outcome|Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375819|NCT02432274|OG006|Outcome|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375820|NCT02432274|OG003|Outcome|Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2|Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
11377012|NCT00961714|BG000|Baseline|OsseoFix|OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
11377013|NCT00961714|FG000|Participant Flow|OsseoFix|OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
10963988|NCT00875342|FG000|Participant Flow|D-cycloserine|DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
10963989|NCT00875342|FG001|Participant Flow|Placebo|Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
10963990|NCT00875342|OG000|Outcome|D-cycloserine|DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
10963991|NCT00875342|OG001|Outcome|Placebo|Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
11191091|NCT02130635|BG004|Baseline|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191092|NCT02130635|BG005|Baseline|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
10963992|NCT00875342|EG000|Reported Event|D-cycloserine|DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
10963993|NCT00875342|EG001|Reported Event|Placebo|Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
10963994|NCT00875420|BG000|Baseline|RAD1901 10 mg|Oral once a day for 28 days
10963036|NCT00869609|FG000|Participant Flow|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963995|NCT00875420|BG001|Baseline|RAD1901 25 mg|Oral once a day for 28 days
10963996|NCT00875420|BG002|Baseline|RAD1901 50 mg|Oral once a day for 28 days
10963997|NCT00875420|BG003|Baseline|RAD1901 100 mg|Oral once a day for 28 days
11377014|NCT00961714|OG000|Outcome|OsseoFix|OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
11240606|NCT02480712|OG000|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
10963998|NCT00875420|BG004|Baseline|Placebo|Oral once a day for 28 days
10963999|NCT00875420|BG005|Baseline|Total|Total of all reporting groups
10964000|NCT00875420|FG000|Participant Flow|RAD1901 10 mg|Oral once a day for 28 days
10964001|NCT00875420|FG001|Participant Flow|RAD1901 25 mg|Oral once a day for 28 days
11191831|NCT02134314|BG001|Baseline|Normal Saline|"35 patients will receive placebo in addition to standard of care immunosuppressive therapy.~Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191832|NCT02134314|BG002|Baseline|Total|Total of all reporting groups
10963037|NCT00869609|FG001|Participant Flow|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963038|NCT00869609|OG000|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963039|NCT00869609|OG001|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963040|NCT00869609|EG000|Reported Event|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
10963041|NCT00869609|EG001|Reported Event|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
11377015|NCT00961714|EG000|Reported Event|OsseoFix|OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
11377016|NCT00567567|BG000|Baseline|Single HST (CEM)|Induction therapy + single myeloablative consolidation
11377017|NCT00567567|BG001|Baseline|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
11377018|NCT00567567|BG002|Baseline|Not Assigned|Patients that either failed during Induction therapy or refused randomization
11377019|NCT00567567|BG003|Baseline|Total|Total of all reporting groups
11377020|NCT00567567|FG000|Participant Flow|Single HST (CEM)|Induction therapy + single myeloablative consolidation
11377021|NCT00567567|FG001|Participant Flow|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
11377022|NCT00567567|FG002|Participant Flow|Not Assigned|Patients that either failed during Induction therapy or refused randomization
11377023|NCT00567567|OG000|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
11377024|NCT00567567|OG001|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
11377025|NCT00567567|OG002|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
11377026|NCT00567567|OG000|Outcome|All Patients|All eligible and evaluable patients enrolled on ANBL0532
11377027|NCT00567567|OG002|Outcome|All Eligible Patients|All Eligible Patients
11377028|NCT00567567|EG000|Reported Event|Single HST (CEM)|Induction therapy + single myeloablative consolidation
11377029|NCT00567567|EG001|Reported Event|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
11377030|NCT00567567|EG002|Reported Event|Not Assigned|Patients that either failed during Induction therapy or refused randomization
11377031|NCT00450450|BG000|Baseline|Control BM Arm|Conventional bone marrow transplant (BM)
10963042|NCT00869622|BG000|Baseline|Risedronate|Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly
11377032|NCT00450450|BG001|Baseline|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
10963043|NCT00869622|BG001|Baseline|Placebo Sugar Pill|Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly
11191093|NCT02130635|BG006|Baseline|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
11191094|NCT02130635|BG007|Baseline|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191095|NCT02130635|BG008|Baseline|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
11191096|NCT02130635|BG009|Baseline|Total|Total of all reporting groups
11191097|NCT02130635|FG000|Participant Flow|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
11377033|NCT00450450|BG002|Baseline|Total|Total of all reporting groups
10963044|NCT00869622|BG002|Baseline|Total|Total of all reporting groups
10963045|NCT00869622|FG000|Participant Flow|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
10964002|NCT00875420|FG002|Participant Flow|RAD1901 50 mg|Oral once a day for 28 days
11191098|NCT02130635|FG001|Participant Flow|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
11191099|NCT02130635|FG002|Participant Flow|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
10963046|NCT00869622|FG001|Participant Flow|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
11191100|NCT02130635|FG003|Participant Flow|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191101|NCT02130635|FG004|Participant Flow|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191102|NCT02130635|FG005|Participant Flow|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
10847195|NCT00282256|BG000|Baseline|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
10963047|NCT00869622|OG000|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
10963048|NCT00869622|OG001|Outcome|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
10964003|NCT00875420|FG003|Participant Flow|RAD1901 100 mg|Oral once a day for 28 days
10964004|NCT00875420|FG004|Participant Flow|Placebo|Oral once a day for 28 days
10851413|NCT00306202|OG000|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained.
10964005|NCT00875420|OG000|Outcome|RAD1901 10 mg|Oral once a day for 28 days
10850263|NCT00301067|BG000|Baseline|Temozolomide and Calcitriol (Cohort 1-3+Expansion)|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
10850264|NCT00301067|FG000|Participant Flow|Cohort 1 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
10964006|NCT00875420|OG001|Outcome|RAD1901 25 mg|Oral once a day for 28 days
10964007|NCT00875420|OG002|Outcome|RAD1901 50 mg|Oral once a day for 28 days
10963049|NCT00869622|OG001|Outcome|Placebo + Calcium and Vitamin D|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
11191103|NCT02130635|FG006|Participant Flow|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
10851414|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained.
10851415|NCT00306202|OG001|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained.
10963050|NCT00869622|EG000|Reported Event|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
11191104|NCT02130635|FG007|Participant Flow|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11377034|NCT00450450|FG000|Participant Flow|Control BM Arm|Conventional bone marrow transplant (BM)
10963051|NCT00869622|EG001|Reported Event|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
10963052|NCT00869778|BG000|Baseline|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
10963053|NCT00869778|BG001|Baseline|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
11377035|NCT00450450|FG001|Participant Flow|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
11377036|NCT00450450|OG000|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
11377037|NCT00450450|OG001|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
11377038|NCT00450450|EG000|Reported Event|Control BM Arm|Conventional bone marrow transplant (BM)
11377039|NCT00450450|EG001|Reported Event|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
11377040|NCT00346164|BG000|Baseline|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
11191105|NCT02130635|FG008|Participant Flow|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
10963054|NCT00869778|BG002|Baseline|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
10963055|NCT00869778|BG003|Baseline|Total|Total of all reporting groups
10963056|NCT00869778|FG000|Participant Flow|εPA-44 900μg|Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
10963057|NCT00869778|FG001|Participant Flow|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
10963058|NCT00869778|FG002|Participant Flow|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
10963059|NCT00869778|OG000|Outcome|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
10963060|NCT00869778|OG001|Outcome|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
11191106|NCT02130635|OG000|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
11191107|NCT02130635|OG001|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
10851416|NCT00306202|OG000|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
10963061|NCT00869778|OG002|Outcome|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
10963062|NCT00869778|OG000|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
10963063|NCT00869778|OG001|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
10963064|NCT00869778|OG002|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
10963065|NCT00869778|EG000|Reported Event|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28."
10963066|NCT00869778|EG001|Reported Event|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
10963067|NCT00869778|EG002|Reported Event|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
10963068|NCT00869791|BG000|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD
10964008|NCT00875420|OG003|Outcome|RAD1901 100 mg|Oral once a day for 28 days
10964009|NCT00875420|OG004|Outcome|Placebo|Oral once a day for 28 days
10964010|NCT00875420|EG000|Reported Event|RAD1901 10 mg|Oral once a day for 28 days
10964011|NCT00875420|EG001|Reported Event|RAD1901 25 mg|Oral once a day for 28 days
10964012|NCT00875420|EG002|Reported Event|RAD1901 50 mg|Oral once a day for 28 days
10851417|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
10851418|NCT00306202|OG000|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
10851419|NCT00306202|OG000|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
10851420|NCT00306202|OG002|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
10964013|NCT00875420|EG003|Reported Event|RAD1901 100 mg|Oral once a day for 28 days
10851444|NCT00306384|FG000|Participant Flow|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
10851445|NCT00306384|FG001|Participant Flow|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
10851446|NCT00306384|FG002|Participant Flow|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
10851447|NCT00306384|OG000|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
10851448|NCT00306384|OG001|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
10851449|NCT00306384|OG002|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
10851450|NCT00306384|EG000|Reported Event|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
10851451|NCT00306384|EG001|Reported Event|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
11191108|NCT02130635|OG000|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
11191109|NCT02130635|OG001|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191110|NCT02130635|OG002|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191111|NCT02130635|OG003|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191112|NCT02130635|OG004|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
11191113|NCT02130635|OG005|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191114|NCT02130635|OG006|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
11191115|NCT02130635|OG000|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
11191116|NCT02130635|OG000|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191117|NCT02130635|OG001|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11191118|NCT02130635|OG002|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191119|NCT02130635|OG003|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
11191120|NCT02130635|OG004|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191121|NCT02130635|OG005|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
10851452|NCT00306384|EG002|Reported Event|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
10851453|NCT00306488|BG000|Baseline|Participant Information|
10964014|NCT00875420|EG004|Reported Event|Placebo|Oral once a day for 28 days
10963069|NCT00869791|FG000|Participant Flow|IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)|In this arm there were 2 treatment periods of one week each. During period 1, 14 subjects received 7 days of IPX066 first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 14 subjects received IR CD-LD for 7 days.
10963070|NCT00869791|FG001|Participant Flow|IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)|In this arm there were 2 treatment periods of one week each. During period 1, 13 subjects received 7 days of IR CD-LD first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 13 subjects received IPX066 for 7 days.
10963071|NCT00869791|OG000|Outcome|IPX066|All participants who received IPX066 in either study period
10963072|NCT00869791|OG001|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
10963073|NCT00869791|EG000|Reported Event|IPX066|All participants who received IPX066 in either study period
10963074|NCT00869791|EG001|Reported Event|CD-LD IR|All participants who received IR CD-LD in either study period
10963075|NCT00869947|BG000|Baseline|Prosthesis|Subjects with transtibial amputation using a passive ankle-foot prosthesis
10963076|NCT00869947|BG001|Baseline|Non-amputee|Non-amputees
10963077|NCT00869947|BG002|Baseline|Total|Total of all reporting groups
10963078|NCT00869947|FG000|Participant Flow|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
10963079|NCT00869947|FG001|Participant Flow|Non-amputees|Non-amputees
10963080|NCT00869947|OG000|Outcome|Participants With an Amputation Using a Passive Prosthesis|
10963081|NCT00869947|OG001|Outcome|Participants With an Amputation Using a Powered Prosthesis|
10963082|NCT00869947|OG002|Outcome|Non-amputees|
10963083|NCT00869947|OG002|Outcome|Non-Amputees|
10851454|NCT00306488|FG000|Participant Flow|OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day. The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
10851455|NCT00306488|OG000|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
10851456|NCT00306488|OG001|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
10851457|NCT00306488|EG000|Reported Event|Participant Adverse Event Information|
10851458|NCT00306527|BG000|Baseline|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
10851459|NCT00306527|BG001|Baseline|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
10851460|NCT00306527|BG002|Baseline|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
10851461|NCT00306527|BG003|Baseline|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
10851462|NCT00306527|BG004|Baseline|Total|Total of all reporting groups
10851463|NCT00306527|FG000|Participant Flow|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
10963084|NCT00869947|EG000|Reported Event|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
10963085|NCT00869947|EG001|Reported Event|Non-amputees|Non-amputees
10963086|NCT00869960|BG000|Baseline|Combination Antiretroviral Therapy|Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
11375821|NCT02432274|OG004|Outcome|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375822|NCT02432274|OG005|Outcome|Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375823|NCT02432274|OG006|Outcome|Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375824|NCT02432274|OG007|Outcome|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375825|NCT02432274|OG000|Outcome|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle=28 days.
11375826|NCT02432274|OG001|Outcome|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle=21 days.
11375827|NCT02432274|EG000|Reported Event|Lenvatinib 5 mg/m^2|Eligible participants of age group 2 to <6 years first underwent a 21-day run-in period with lenvatinib 5 mg/m^2, once daily as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension) before receiving lenvatinib 11 mg/m^2 or 14 mg/m^2 in Cycle 1 of Cohort 1 (Single-agent Dose-finding).
11375828|NCT02432274|EG001|Reported Event|Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2|Participants (age group 2 to <6 years [following completion of run-in period] and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375829|NCT02432274|EG002|Reported Event|Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2|Participants (age group 2 to <6 years [following completion of run-in period] and 6 to <18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
11375830|NCT02432274|EG003|Reported Event|Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2|Participants (of age group 6 to <18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
10963087|NCT00869960|FG000|Participant Flow|Antiretroviral Therapy|Healthy volunteers
10963088|NCT00869960|OG000|Outcome|Antiretroviral Therapy|Healthy volunteers
10963089|NCT00869960|EG000|Reported Event|Antiretroviral Therapy|Healthy volunteers
10963090|NCT00869999|BG000|Baseline|Treatment Arm|All patients received treatment with everolimus-rituximab on this single am study
10963091|NCT00869999|FG000|Participant Flow|Everolimus-Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
10963092|NCT00869999|OG000|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
10963093|NCT00869999|EG000|Reported Event|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
10963094|NCT00870103|BG000|Baseline|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
10963095|NCT00870103|FG000|Participant Flow|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
10963096|NCT00870103|OG000|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
10963097|NCT00870103|EG000|Reported Event|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
10963098|NCT00870194|BG000|Baseline|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
10963099|NCT00870194|BG001|Baseline|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
10963100|NCT00870194|BG002|Baseline|Total|Total of all reporting groups
10963101|NCT00870194|FG000|Participant Flow|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
10963102|NCT00870194|FG001|Participant Flow|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
10963103|NCT00870194|OG000|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
10851464|NCT00306527|FG001|Participant Flow|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
11375831|NCT02432274|EG004|Reported Event|Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2|Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
11375832|NCT02432274|EG005|Reported Event|Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
11375833|NCT02432274|EG006|Reported Event|Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375834|NCT02432274|EG007|Reported Event|Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
11375835|NCT02432274|EG008|Reported Event|Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2|Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m^2/day intravenously and etoposide 100 mg/m^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
11375836|NCT02428192|BG000|Baseline|Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)|"Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11375837|NCT02428192|BG001|Baseline|Cohort B (Nivolumab and Ipilimumab)|"Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11375838|NCT02428192|BG002|Baseline|Total|Total of all reporting groups
11375839|NCT02428192|FG000|Participant Flow|Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)|"Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11375840|NCT02428192|FG001|Participant Flow|Cohort B (Nivolumab and Ipilimumab)|"Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11375841|NCT02428192|OG000|Outcome|Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)|"Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11375842|NCT02428192|OG000|Outcome|Cohort B (Nivolumab and Ipilimumab)|"Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11375843|NCT02428192|OG001|Outcome|Cohort B (Nivolumab and Ipilimumab)|"Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11191122|NCT02130635|EG000|Reported Event|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
11191123|NCT02130635|EG001|Reported Event|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
11191124|NCT02130635|EG002|Reported Event|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
11191125|NCT02130635|EG003|Reported Event|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11375844|NCT02428192|EG000|Reported Event|Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)|"Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11375845|NCT02428192|EG001|Reported Event|Cohort B (Nivolumab and Ipilimumab)|"Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11375846|NCT02399215|BG000|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nintedanib: Given PO~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11375847|NCT02399215|FG000|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nintedanib: Given PO~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11375848|NCT02399215|OG000|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nintedanib: Given PO~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11375849|NCT02399215|EG000|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nintedanib: Given PO~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11375850|NCT02311478|BG000|Baseline|T380A Copper IUD|"All participants will receive a T380A copper intrauterine device when enrolled. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.~T380A Intrauterine Copper Contraceptive: The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus."
11375851|NCT02311478|FG000|Participant Flow|T380A Copper IUD|All participants will receive a T380A copper intrauterine device when enrolled. The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.
11375852|NCT02311478|OG000|Outcome|T380A Copper IUD|"All participants will receive a T380A copper intrauterine device when enrolled. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.~T380A Intrauterine Copper Contraceptive: The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus."
11375853|NCT02311478|OG000|Outcome|T380A Copper IUD|All participants will receive a T380A copper intrauterine device when enrolled. The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.
11375854|NCT02311478|EG000|Reported Event|T380A Copper IUD|"All participants will receive a T380A copper intrauterine device when enrolled. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.~T380A Intrauterine Copper Contraceptive: The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus."
11375855|NCT02292238|BG000|Baseline|Benfotiamine|"The patients in this arm will be treated with benfotiamine~Benfotiamine: • To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
11375856|NCT02292238|BG001|Baseline|Placebo|"The patients in this arm will be treated with placebo~Benfotiamine: • To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
11191126|NCT02130635|EG004|Reported Event|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
11375857|NCT02292238|BG002|Baseline|Total|Total of all reporting groups
10963104|NCT00870194|OG001|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
11191127|NCT02130635|EG005|Reported Event|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191128|NCT02130635|EG006|Reported Event|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
11191129|NCT02130635|EG007|Reported Event|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
11191130|NCT02130635|EG008|Reported Event|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
11191131|NCT02130765|BG000|Baseline|Randomized Subjects-Ablation|
11191132|NCT02130765|BG001|Baseline|Randomized Subjects-Control|
11191133|NCT02130765|BG002|Baseline|Registry Subjects|
11191134|NCT02130765|BG003|Baseline|Early Withdrawal Subjects|
11191135|NCT02130765|BG004|Baseline|Total|Total of all reporting groups
11191136|NCT02130765|FG000|Participant Flow|Randomized Subjects-Ablation|Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
11191137|NCT02130765|FG001|Participant Flow|Randomized Subjects- Control|Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
11191138|NCT02130765|FG002|Participant Flow|Registry Subjects|Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation [NIPS] or electrophysiology [EP] study without monomorphic ventricular tachycardia [MMVT] and absence of spontaneous documented MMVT).
11191139|NCT02130765|FG003|Participant Flow|Early Withdrawal Subjects|Subjects enrolled but withdrawn early from the study
11191140|NCT02130765|OG000|Outcome|Randomized Subjects-Ablation|Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
11191141|NCT02130765|OG001|Outcome|Randomized Subjects- Control|Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
11191142|NCT02130765|OG002|Outcome|Registry Subjects|Enrolled subjects who do not meet entry criteria (specifically NIPS or EP Study without MMVT and absence of spontaneous documented MMVT).
11191143|NCT02130765|OG003|Outcome|Early WIthdrawal Subjects|Subjects enrolled but withdrawn early from the study
11191144|NCT02130765|OG003|Outcome|Early Withdrawal Subjects|Subjects enrolled but withdrawn early from the study
11191145|NCT02130765|EG000|Reported Event|All Enrolled Subjects|All Enrolled Subjects
11191146|NCT02130765|EG001|Reported Event|Randomized Subjects- Ablation|Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility (TM) Ablation Catheter System in addition to routine drug therapy).
11191147|NCT02130765|EG002|Reported Event|Randomized Subjects-Control|Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy).
11191148|NCT02130765|EG003|Reported Event|Registry Subjects|Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation [NIPS] or electrophysiology [EP] study without monomorphic ventricular tachycardia [MMVT] and absence of spontaneous documented MMVT).
11191149|NCT02130765|EG004|Reported Event|Early Withdrawal Subjects|Subjects enrolled but withdrawn early from the study.
11191833|NCT02134314|FG000|Participant Flow|C1-Inhibitor (Berinert) (Human) (C1INH)|"35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191834|NCT02134314|FG001|Participant Flow|Normal Saline|"35 patients will receive placebo in addition to standard of care immunosuppressive therapy.~Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
10963105|NCT00870194|EG000|Reported Event|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
10963106|NCT00870194|EG001|Reported Event|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
10963107|NCT00870233|BG000|Baseline|GYN Pts Undergoing Surgery|"This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).~online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended."
10963108|NCT00870233|FG000|Participant Flow|GYN Pts Undergoing Surgery|"This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).~online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended."
10963109|NCT00870233|OG000|Outcome|GYN Pts Undergoing Surgery|"This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).~online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended."
10963110|NCT00870233|OG000|Outcome|Study Nurse Clinicians|Email alerts were sent to study nurses when concerning participant responses were entered. The nurse assessments of STAR's usefulness were measured via an exit survey. Alerts were considered concerning according to pre-specified limits set by the Gynecologic Oncology Service. This is the same system presently used to triage patient phone calls. Any actions taken by the nurses in response to these alerts were recorded. However, specific responses were not required. Patients were encouraged to call their physician's office if medical attention was needed, as there was no regularly scheduled monitoring of information entered into the STAR system.
10963111|NCT00870233|EG000|Reported Event|GYN Pts Undergoing Surgery|"This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).~online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended."
10964015|NCT00875433|BG000|Baseline|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
11375858|NCT02292238|FG000|Participant Flow|Benfotiamine|"The patients in this arm will be treated with benfotiamine Benfotiamine: • To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
11191150|NCT02130986|BG000|Baseline|Procalcitonin (PCT) Group|"Procalcitonin level: A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.~Results of procalcitonin (PCT) level to treating clinician: In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.~Provide PCT guideline to treating clinician: Procalcitonin antibiotic guideline --~PCT level (ug/L)-- Bacterial etiology -- Recommendation < 0.1-- Very unlikely -- Antibiotics strongly discouraged 0.1 - 0.25 -- Unlikely--Antibiotics discouraged > 0.25 - 0.5--Likely -- Antibiotics recommended > 0.5-- Very likely -- Antibiotics strongly recommended~Telephone Visit: We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30"
11191151|NCT02130986|BG001|Baseline|Usual Care (UC) Group|"Telephone Visit at Day 15 and Day 30~Telephone Visit: We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30"
11191152|NCT02130986|BG002|Baseline|Total|Total of all reporting groups
11191153|NCT02130986|FG000|Participant Flow|Procalcitonin (PCT) Group|"Procalcitonin (PCT)~Results of procalcitonin level provided to treating clinician (initial in the ED, 6-24 hrs after initial. and Day 3, 5, 7 if in hospital AND on abx or at the treating clinician's discretion)~Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire~Bio-bank samples collected in ED for storage at Coordinating Center"
11191154|NCT02130986|FG001|Participant Flow|Usual Care (UC) Group|"Usual Care~Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire~Bio-bank samples collected in ED for storage at Coordinating Center"
11191835|NCT02134314|OG000|Outcome|C1-Inhibitor (Berinert) (Human) (C1INH)|"35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg intravenous infusion administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191836|NCT02134314|OG001|Outcome|Normal Saline|"35 patients will receive placebo in addition to standard of care immunosuppressive therapy.~Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191155|NCT02130986|OG000|Outcome|Procalcitonin (PCT) Group|"Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30~Procalcitonin level: A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.~Results of procalcitonin (PCT) level to treating clinician: In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.~Provide procalcitonin guideline to treating clinician."
11191156|NCT02130986|OG001|Outcome|Usual Care Group|"Telephone Visit at Day 15 and Day 30~Telephone Visit: We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30"
11375859|NCT02292238|FG001|Participant Flow|Placebo|"The patients in this arm will be treated with placebo~To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients. Placebo group received identical capsules without benfotiamine"
11375860|NCT02292238|OG000|Outcome|Benfotiamine|"The patients in this arm will be treated with benfotiamine~Benfotiamine: • To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
11375861|NCT02292238|OG001|Outcome|Placebo|"The patients in this arm will be treated with placebo~Benfotiamine: • To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
11375862|NCT02292238|OG000|Outcome|Benfotiamine|Patients were treated with 600 mg/day of benfotiamine
11375863|NCT02292238|EG000|Reported Event|Benfotiamine|"To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients. Placebo group received identical capsules without benfotiamine"
11375864|NCT02292238|EG001|Reported Event|Placebo|"The patients in this arm will be treated with placebo~To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients. Placebo group received identical capsules without benfotiamine"
11375865|NCT02287818|BG000|Baseline|Placebo|"Placebo plus Febuxostat~Placebo: Placebo twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375866|NCT02287818|BG001|Baseline|AC-201|"AC-201 CR tablet plus Febuxostat~AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375867|NCT02287818|BG002|Baseline|Total|Total of all reporting groups
11375868|NCT02287818|FG000|Participant Flow|Placebo|"Placebo plus Febuxostat~Placebo: Placebo twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375869|NCT02287818|FG001|Participant Flow|AC-201|"AC-201 CR tablet plus Febuxostat~AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375870|NCT02287818|OG000|Outcome|Placebo|"Placebo plus Febuxostat~Placebo: Placebo twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375871|NCT02287818|OG001|Outcome|AC-201|"AC-201 CR tablet plus Febuxostat~AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375872|NCT02287818|EG000|Reported Event|Placebo|"Placebo plus Febuxostat~Placebo: Placebo twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375873|NCT02287818|EG001|Reported Event|AC-201|"AC-201 CR tablet plus Febuxostat~AC-201: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12~Febuxostat: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL"
11375874|NCT02277119|BG000|Baseline|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11191157|NCT02130986|OG000|Outcome|Procalcitonin (PCT) Group|"Provide PCT results and procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30 for # of ABX days~A procalcitonin (PCT) will be drawn within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion. Results & guideline provided to the treating clinician.~PCT guideline to treating clinician:~Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation~< 0.1 --Very unlikely -- Antibiotics strongly discouraged~0.1 - 0.25 -- Unlikely --Antibiotics discouraged~> 0.25 -- 0.5--Likely--Antibiotics recommended~> 0.5 --Very likely -- Antibiotics strongly recommended"
11191158|NCT02130986|OG000|Outcome|Procalcitonin (PCT) Group|"Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30~Procalcitonin level: A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.~Results of procalcitonin (PCT) level to treating clinician: In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.~Provide procalcitonin guideline to treating clinician: Procalcitonin antibiotic guideline --~Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation < 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1) 0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1"
11191159|NCT02130986|EG000|Reported Event|Procalcitonin (PCT) Group|"Procalcitonin (PCT)~Results of procalcitonin level provided to treating clinician (initial in the ED, 6-24 hrs after initial. and Day 3, 5, 7 if in hospital AND on abx or at the treating clinician's discretion)~Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire~Bio-bank samples collected in ED for storage at Coordinating Center"
11191160|NCT02130986|EG001|Reported Event|Usual Care Group|"Usual Care~Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire~Bio-bank samples collected in ED for storage at Coordinating Center"
11191161|NCT02130999|BG000|Baseline|Overall Number of Baseline Participants|14 subjects total participated in the study
11191162|NCT02130999|FG000|Participant Flow|Sequence A|"Single oral dose of tasimelteon 20 mg on Day 1~Single I.V. dose of tasimelteon 2 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
11191163|NCT02130999|FG001|Participant Flow|Sequence B|"Single I.V. dose of tasimelteon 2 mg on Day 1~Single oral dose of tasimelteon 20 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
11191164|NCT02130999|OG000|Outcome|Absolute Bioavailability|
11191165|NCT02130999|OG000|Outcome|Oral (20 mg)|
11191166|NCT02130999|OG001|Outcome|IV (2 mg)|
11191167|NCT02130999|OG000|Outcome|Tasimelteon 20mg Oral|
11191168|NCT02130999|OG001|Outcome|Tasimelteon 2mg IV|
11191169|NCT02130999|OG002|Outcome|All Subjects|
11191170|NCT02130999|EG000|Reported Event|Tasimelteon 20mg Oral|
11191171|NCT02130999|EG001|Reported Event|Tasimelteon 2mg IV|
11191172|NCT02130999|EG002|Reported Event|All Subjects|
11191173|NCT02131064|BG000|Baseline|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
11191174|NCT02131064|BG001|Baseline|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
11191175|NCT02131064|BG002|Baseline|Total|Total of all reporting groups
11191176|NCT02131064|FG000|Participant Flow|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
11191177|NCT02131064|FG001|Participant Flow|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
11191178|NCT02131064|OG000|Outcome|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
11191179|NCT02131064|OG001|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
11191180|NCT02131064|OG000|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
11191181|NCT02131064|EG000|Reported Event|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
11191182|NCT02131064|EG001|Reported Event|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
11191183|NCT02131129|BG000|Baseline|rTMS|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~rTMS: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191837|NCT02134314|OG000|Outcome|C1-Inhibitor (Berinert) (Human) (C1INH)|"35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191838|NCT02134314|EG000|Reported Event|C1-Inhibitor (Berinert) (Human) (C1INH)|"35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191839|NCT02134314|EG001|Reported Event|Normal Saline|"35 patients will receive placebo in addition to standard of care immunosuppressive therapy.~Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses"
11191840|NCT02134353|BG000|Baseline|Experimental Arm A|"Active treatment. Inhaled Mannitol~Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks"
11191841|NCT02134353|BG001|Baseline|Arm B - Control|"Arm B~Control BD (mannitol 50mg) for 26 weeks"
11191184|NCT02131129|BG001|Baseline|Sham|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Sham Comparator: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191185|NCT02131129|BG002|Baseline|Total|Total of all reporting groups
11191186|NCT02131129|FG000|Participant Flow|rTMS|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~rTMS: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191187|NCT02131129|FG001|Participant Flow|Sham|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Sham Comparator: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191188|NCT02131129|OG000|Outcome|rTMS|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~rTMS: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191189|NCT02131129|OG001|Outcome|Sham|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Sham Comparator: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191190|NCT02131129|EG000|Reported Event|rTMS|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~rTMS: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191191|NCT02131129|EG001|Reported Event|Sham|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Sham Comparator: The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).~Ten sessions over a two week duration"
11191192|NCT02131233|BG000|Baseline|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
11191193|NCT02131233|BG001|Baseline|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
11191194|NCT02131233|BG002|Baseline|Total|Total of all reporting groups
11375875|NCT02277119|BG001|Baseline|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375876|NCT02277119|BG002|Baseline|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375877|NCT02277119|BG003|Baseline|Total|Total of all reporting groups
11375878|NCT02277119|FG000|Participant Flow|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375879|NCT02277119|FG001|Participant Flow|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375880|NCT02277119|FG002|Participant Flow|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11191842|NCT02134353|BG002|Baseline|Total|Total of all reporting groups
11375881|NCT02277119|OG000|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375882|NCT02277119|OG001|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375883|NCT02277119|OG002|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375884|NCT02277119|EG000|Reported Event|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375885|NCT02277119|EG001|Reported Event|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375886|NCT02277119|EG002|Reported Event|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
11375887|NCT02264977|BG000|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375888|NCT02264977|FG000|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375889|NCT02264977|OG000|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375890|NCT02264977|EG000|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11240607|NCT02480712|EG000|Reported Event|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
11240608|NCT02480712|EG001|Reported Event|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
11240609|NCT02480712|EG002|Reported Event|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
11240610|NCT02480764|BG000|Baseline|Azilsartan Medoxomil 40 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
11375891|NCT02255097|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
11375892|NCT02255097|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
11375893|NCT02255097|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
11375894|NCT02255097|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
11375895|NCT02255097|EG001|Reported Event|Pembrolizumab Second Course|Participants who met the criteria for re-treatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 1 year of treatment.
11375896|NCT02218164|BG000|Baseline|Capecitabine or 5-FU With Pegylated Interferon Alpha-2b|"Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.~After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment)."
11240611|NCT02480764|BG001|Baseline|Azilsartan Medoxomil 80 mg|Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks.
11375897|NCT02218164|FG000|Participant Flow|Capecitabine or 5-FU With Pegylated Interferon Alpha-2b|"Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.~After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment)."
11375898|NCT02218164|OG000|Outcome|Capecitabine or 5-FU With Pegylated Interferon Alpha-2b|"Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.~After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment)."
11377041|NCT00346164|BG001|Baseline|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
11191195|NCT02131233|FG000|Participant Flow|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
11191196|NCT02131233|FG001|Participant Flow|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
10851465|NCT00306527|FG002|Participant Flow|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
11375899|NCT02218164|EG000|Reported Event|Capecitabine or 5-FU With Pegylated Interferon Alpha-2b|"Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.~After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment)."
11375900|NCT02200614|BG000|Baseline|Darolutamide (BAY1841788)|Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
11375901|NCT02200614|BG001|Baseline|Placebo|Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).
11375902|NCT02200614|BG002|Baseline|Total|Total of all reporting groups
11375903|NCT02200614|FG000|Participant Flow|Darolutamide (BAY1841788)|Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
11375904|NCT02200614|FG001|Participant Flow|Placebo|Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).
11375905|NCT02200614|OG000|Outcome|Darolutamide (BAY1841788)|Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
11375906|NCT02200614|OG001|Outcome|Placebo|Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).
11375907|NCT02200614|EG000|Reported Event|Darolutamide (DB)|Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind [DB]).
11375908|NCT02200614|EG001|Reported Event|Darolutamide (DB+OL)|Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
11375909|NCT02200614|EG002|Reported Event|Placebo (DB)|Participants received matching placebo 2 tablets twice daily with food (double blind [DB]).
11375910|NCT02200614|EG003|Reported Event|Placebo+Darolutamide (CO)|Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).
11375911|NCT02108652|BG000|Baseline|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
11375912|NCT02108652|FG000|Participant Flow|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
11375913|NCT02108652|OG000|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
11375914|NCT02108652|EG000|Reported Event|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
11375915|NCT02083081|BG000|Baseline|Community Intervention|"Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women~Community level intervention: Community intervention plus individual counseling"
11375916|NCT02083081|BG001|Baseline|Usual Care|Usual care provided by health aides to pregnant women
11375917|NCT02083081|BG002|Baseline|Total|Total of all reporting groups
11375918|NCT02083081|FG000|Participant Flow|Community Intervention|"Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women~Community level intervention: Community intervention plus individual counseling"
11375919|NCT02083081|FG001|Participant Flow|Usual Care|Usual care provided by health aides to pregnant women
11375920|NCT02083081|OG000|Outcome|Community Intervention|"Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women~Community level intervention: Community intervention plus individual counseling"
11375921|NCT02083081|OG001|Outcome|Usual Care|Usual care provided by health aides to pregnant women
11375922|NCT02083081|EG000|Reported Event|Community Intervention|"Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women~Community level intervention: Community intervention plus individual counseling"
11375923|NCT02083081|EG001|Reported Event|Usual Care|Usual care provided by health aides to pregnant women
11375924|NCT02069899|BG000|Baseline|Enrolled-04 Cohort|"Participants enrolled in Study NI-0501-04 were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~In Study NI-0501-04, participants received emapalumab for 4 to 8 weeks. After the treatment period, participants could have undergone HSCT.~For participants for whom an appropriate donor was not identified by Week 8, or in a case where HSCT was delayed for reasons unrelated to the administration of emapalumab, they could continue receiving treatment with emapalumab beyond the foreseen 8 weeks in the current study (NI-0501-05) at the request of the investigator, providing a favorable benefit/risk assessment of treatment was established.~Treatment with emapalumab was not planned for all enrolled participants. For participants who continued receiving emapalumab in the context of this study (NI-0501-05), the dose and timing was either carried forward from the last administered emapalumab dose as part of the parent study in which the participant was enrolled, or an adjusted dose was administered, if necessary."
11375925|NCT02069899|BG001|Baseline|Enrolled-06 Cohort|"All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 were invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants did not receive emapalumab in the current study (NI-0501-05)."
11375926|NCT02069899|BG002|Baseline|Enrolled-CU Cohort|"In exceptional cases, at the spontaneous request of a treating physician, CU treatment was granted to the participants who had exhausted all possible treatment options and who could not be enrolled in a clinical study. All participants who received at least 1 dose of emapalumab were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~Participants could have continued treatment in the context of the current Study (NI-0501-05) while stem cell donor search was ongoing, or if the investigator assessed that continuation of treatment was beneficial."
11375927|NCT02069899|BG003|Baseline|Total|Total of all reporting groups
11375928|NCT02069899|FG000|Participant Flow|Enrolled-04 Cohort|"Participants enrolled in Study NI-0501-04 were invited to participate for long-term follow-up for 1 year either after haematopoietic stem cell transplantation (HSCT) or after the last administration of emapalumab.~In Study NI-0501-04, participants received emapalumab for 4 to 8 weeks. After the treatment period, participants could have undergone HSCT.~For participants for whom an appropriate donor was not identified by Week 8, or in a case where HSCT was delayed for reasons unrelated to the administration of emapalumab, they could continue receiving treatment with emapalumab beyond the foreseen 8 weeks in the current study (NI-0501-05) at the request of the investigator, providing a favorable benefit/risk assessment of treatment was established.~Treatment with emapalumab was not planned for all enrolled participants. For participants who continued receiving emapalumab in the context of this study (NI-0501-05), the dose and timing was either carried forward from the last administered emapalumab dose as part of the parent study in which the participant was enrolled, or an adjusted dose was administered, if necessary."
11375929|NCT02069899|FG001|Participant Flow|Enrolled-06 Cohort|"All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 were invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants did not receive emapalumab in the current study (NI-0501-05)."
11375930|NCT02069899|FG002|Participant Flow|Enrolled-CU Cohort|"In exceptional cases, at the spontaneous request of a treating physician, CU treatment was granted to the participants who had exhausted all possible treatment options and who could not be enrolled in a clinical study. All participants who received at least 1 dose of emapalumab were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~Participants could have continued treatment in the context of the current Study (NI-0501-05) while stem cell donor search was ongoing, or if the investigator assessed that continuation of treatment was beneficial."
11375931|NCT02069899|OG000|Outcome|Enrolled-04 Cohort|"Participants enrolled in Study NI-0501-04 were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~In Study NI-0501-04, participants received emapalumab for 4 to 8 weeks. After the treatment period, participants could have undergone HSCT.~For participants for whom an appropriate donor was not identified by Week 8, or in a case where HSCT was delayed for reasons unrelated to the administration of emapalumab, they could continue receiving treatment with emapalumab beyond the foreseen 8 weeks in the current study (NI-0501-05) at the request of the investigator, providing a favorable benefit/risk assessment of treatment was established.~Treatment with emapalumab was not planned for all enrolled participants. For participants who continued receiving emapalumab in the context of this study (NI-0501-05), the dose and timing was either carried forward from the last administered emapalumab dose as part of the parent study in which the participant was enrolled, or an adjusted dose was administered, if necessary."
11375932|NCT02069899|OG001|Outcome|Enrolled-06 Cohort|"All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 were invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants did not receive emapalumab in the current study (NI-0501-05)."
11191197|NCT02131233|OG000|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
11191198|NCT02131233|OG001|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
11191199|NCT02131233|EG000|Reported Event|Raltegravir 1200 mg QD + Truvada|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
11191843|NCT02134353|FG000|Participant Flow|Experimental Arm A|"Active treatment. Inhaled Mannitol~Inhaled mannitol: Inhaled mannitol 400 mg twice a day (BD) for 26 weeks"
10851466|NCT00306527|FG003|Participant Flow|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
10963112|NCT00870363|BG000|Baseline|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10964016|NCT00875433|FG000|Participant Flow|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
11191844|NCT02134353|FG001|Participant Flow|Arm B - Control|"Arm B~Control (mannitol 50mg) twice a day (BD) for 26 weeks"
10963113|NCT00870363|BG001|Baseline|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963114|NCT00870363|BG002|Baseline|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963115|NCT00870363|BG003|Baseline|HIV Negative Controls Not on ART|HIV-negative
10963116|NCT00870363|BG004|Baseline|Total|Total of all reporting groups
11191845|NCT02134353|OG000|Outcome|Experimental Arm A|"Active treatment. Inhaled Mannitol~Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks"
11191200|NCT02131233|EG001|Reported Event|Raltegravir 400 mg BID + Truvada|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
11191846|NCT02134353|OG001|Outcome|Arm B - Control|"Arm B~Control BD (mannitol 50mg) for 26 weeks"
10850265|NCT00301067|FG001|Participant Flow|Cohort 2 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11191201|NCT02131259|BG000|Baseline|Afatinib Dimaleate|The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
11191202|NCT02131259|FG000|Participant Flow|Afatinib Dimaleate|The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
10963117|NCT00870363|FG000|Participant Flow|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963118|NCT00870363|FG001|Participant Flow|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963119|NCT00870363|FG002|Participant Flow|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963120|NCT00870363|FG003|Participant Flow|HIV Negative Controls Not on ART|HIV-negative
10963121|NCT00870363|OG000|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963122|NCT00870363|OG001|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10964017|NCT00875433|OG000|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
11375933|NCT02069899|OG002|Outcome|Enrolled-CU Cohort|"In exceptional cases, at the spontaneous request of a treating physician, CU treatment was granted to the participants who had exhausted all possible treatment options and who could not be enrolled in a clinical study. All participants who received at least 1 dose of emapalumab were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~Participants could have continued treatment in the context of the current Study (NI-0501-05) while stem cell donor search was ongoing, or if the investigator assessed that continuation of treatment was beneficial."
11375934|NCT02069899|OG000|Outcome|Enrolled-06 Cohort|"All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 were invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants did not receive emapalumab in the current study (NI-0501-05)."
11375935|NCT02069899|EG000|Reported Event|Enrolled-04 Cohort|"Participants enrolled in Study NI-0501-04 were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~In Study NI-0501-04, participants received emapalumab for 4 to 8 weeks. After the treatment period, participants could have undergone HSCT.~For participants for whom an appropriate donor was not identified by Week 8, or in a case where HSCT was delayed for reasons unrelated to the administration of emapalumab, they could continue receiving treatment with emapalumab beyond the foreseen 8 weeks in the current study (NI-0501-05) at the request of the investigator, providing a favorable benefit/risk assessment of treatment was established.~Treatment with emapalumab was not planned for all enrolled participants. For participants who continued receiving emapalumab in the context of this study (NI-0501-05), the dose and timing was either carried forward from the last administered emapalumab dose as part of the parent study in which the participant was enrolled, or an adjusted dose was administered, if necessary."
11375936|NCT02069899|EG001|Reported Event|Enrolled-06 Cohort|"All participants who received at least 1 dose of emapalumab and were monitored for at least 4 weeks after the last drug administration in Study NI-0501-06 were invited to participate for long-term follow-up for 1 year after the last administration of emapalumab.~Participants did not receive emapalumab in the current study (NI-0501-05)."
11375937|NCT02069899|EG002|Reported Event|Enrolled-CU Cohort|"In exceptional cases, at the spontaneous request of a treating physician, CU treatment was granted to the participants who had exhausted all possible treatment options and who could not be enrolled in a clinical study. All participants who received at least 1 dose of emapalumab were invited to participate for long-term follow-up for 1 year either after HSCT or after the last administration of emapalumab.~Participants could have continued treatment in the context of the current Study (NI-0501-05) while stem cell donor search was ongoing, or if the investigator assessed that continuation of treatment was beneficial."
11375938|NCT02021812|BG000|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375939|NCT02021812|FG000|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375940|NCT02021812|OG000|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375941|NCT02021812|EG000|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis~Branched TAG® Device"
11375942|NCT02018861|BG000|Baseline|Parsaclisib 5 mg QD|Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
11375943|NCT02018861|BG001|Baseline|Parsaclisib 10 mg QD|Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
11375944|NCT02018861|BG002|Baseline|Parsaclisib 15 mg QD|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
11375945|NCT02018861|BG003|Baseline|Parsaclisib 20 mg QD|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
11375946|NCT02018861|BG004|Baseline|Parsaclisib 30 mg QD|Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
11375947|NCT02018861|BG005|Baseline|Parsaclisib 45 mg QD|Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
11375948|NCT02018861|BG006|Baseline|Parsaclisib 20 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375949|NCT02018861|BG007|Baseline|Parsaclisib 30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375950|NCT02018861|BG008|Baseline|Parsaclisib 15 mg QD + R-ICE|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375951|NCT02018861|BG009|Baseline|Parsaclisib 20 mg QD + R-ICE|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375952|NCT02018861|BG010|Baseline|Total|Total of all reporting groups
11375953|NCT02018861|FG000|Participant Flow|Parsaclisib 5 mg QD|Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
11375954|NCT02018861|FG001|Participant Flow|Parsaclisib 10 mg QD|Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
11375955|NCT02018861|FG002|Participant Flow|Parsaclisib 15 mg QD|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
11191847|NCT02134353|EG000|Reported Event|Experimental Arm A|"Active treatment. Inhaled Mannitol~Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks~Subjects randomised and treated."
11191203|NCT02131259|OG000|Outcome|Afatinib Dimaleate|The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
11375956|NCT02018861|FG003|Participant Flow|Parsaclisib 20 mg QD|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
11375957|NCT02018861|FG004|Participant Flow|Parsaclisib 30 mg QD|Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
11375958|NCT02018861|FG005|Participant Flow|Parsaclisib 45 mg QD|Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
11375959|NCT02018861|FG006|Participant Flow|Parsaclisib 20 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375960|NCT02018861|FG007|Participant Flow|Parsaclisib 30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375961|NCT02018861|FG008|Participant Flow|Parsaclisib 15 mg QD + R-ICE|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375962|NCT02018861|FG009|Participant Flow|Parsaclisib 20 mg QD + R-ICE|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375963|NCT02018861|OG000|Outcome|Parsaclisib 5 mg QD|Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
11375964|NCT02018861|OG001|Outcome|Parsaclisib 10 mg QD|Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
11375965|NCT02018861|OG002|Outcome|Parsaclisib 15 mg QD|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
11375966|NCT02018861|OG003|Outcome|Parsaclisib 20 mg QD|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
11375967|NCT02018861|OG004|Outcome|Parsaclisib 30 mg QD|Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
11375968|NCT02018861|OG005|Outcome|Parsaclisib 45 mg QD|Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
11375969|NCT02018861|OG006|Outcome|Parsaclisib 20 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375970|NCT02018861|OG007|Outcome|Parsaclisib 30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375971|NCT02018861|OG008|Outcome|Parsaclisib 15 mg QD + R-ICE|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375972|NCT02018861|OG009|Outcome|Parsaclisib 20 mg QD + R-ICE|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375973|NCT02018861|OG000|Outcome|Parsaclisib 20 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375974|NCT02018861|OG001|Outcome|Parsaclisib 30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375975|NCT02018861|OG000|Outcome|Parsaclisib 15 mg QD + R-ICE|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375976|NCT02018861|OG001|Outcome|Parsaclisib 20 mg QD + R-ICE|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375977|NCT02018861|OG000|Outcome|Parsaclisib 20/30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375978|NCT02018861|OG000|Outcome|Parsaclisib 20/30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375979|NCT02018861|EG000|Reported Event|Parsaclisib 5 mg QD|Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
11375980|NCT02018861|EG001|Reported Event|Parsaclisib 10 mg QD|Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
11375981|NCT02018861|EG002|Reported Event|Parsaclisib 15 mg QD|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
11375982|NCT02018861|EG003|Reported Event|Parsaclisib 20 mg QD|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
11375983|NCT02018861|EG004|Reported Event|Parsaclisib 30 mg QD|Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
10851467|NCT00306527|OG000|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
11191848|NCT02134353|EG001|Reported Event|Arm B - Control|"Arm B~Control BD (mannitol 50mg) for 26 weeks~Subjects randomised and treated."
11375984|NCT02018861|EG005|Reported Event|Parsaclisib 45 mg QD|Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
11375985|NCT02018861|EG006|Reported Event|Parsaclisib 20 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375986|NCT02018861|EG007|Reported Event|Parsaclisib 30 mg + Itacitinib 300 mg|Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
11375987|NCT02018861|EG008|Reported Event|Parsaclisib 15 mg QD + R-ICE|Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375988|NCT02018861|EG009|Reported Event|Parsaclisib 20 mg QD + R-ICE|Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
11375989|NCT02018861|EG010|Reported Event|Total|All participants in all treatment arms combined.
11375990|NCT01772472|BG000|Baseline|Trastuzumab|Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.
11375991|NCT01772472|BG001|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
11375992|NCT01772472|BG002|Baseline|Total|Total of all reporting groups
11375993|NCT01772472|FG000|Participant Flow|Trastuzumab|Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.
11375994|NCT01772472|FG001|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
11375995|NCT01772472|OG000|Outcome|Trastuzumab|Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.
11375996|NCT01772472|OG001|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
11375997|NCT01772472|EG000|Reported Event|Trastuzumab|Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.
11375998|NCT01772472|EG001|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
11375999|NCT01721759|BG000|Baseline|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
11376000|NCT01721759|FG000|Participant Flow|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
11376001|NCT01721759|OG000|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
11376002|NCT01721759|EG000|Reported Event|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
11376003|NCT01711541|BG000|Baseline|Dose Level 0|ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction
11376004|NCT01711541|BG001|Baseline|Dose Level 0B|ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376005|NCT01711541|BG002|Baseline|Dose Level 1|ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376006|NCT01711541|BG003|Baseline|Dose Level 2|ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376007|NCT01711541|BG004|Baseline|Dose Level 3|ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11191204|NCT02131259|EG000|Reported Event|Afatinib Dimaleate|The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
11191205|NCT02131272|BG000|Baseline|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191206|NCT02131272|BG001|Baseline|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191207|NCT02131272|BG002|Baseline|Total|Total of all reporting groups
11191208|NCT02131272|FG000|Participant Flow|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11376008|NCT01711541|BG005|Baseline|Total|Total of all reporting groups
11376009|NCT01711541|FG000|Participant Flow|Dose Level 0|ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction
11376010|NCT01711541|FG001|Participant Flow|Dose Level 0B|ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376011|NCT01711541|FG002|Participant Flow|Dose Level 1|ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
10851468|NCT00306527|OG001|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
11191209|NCT02131272|FG001|Participant Flow|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191849|NCT02134522|BG000|Baseline|C-pap Intervention|Subjects undergoing measurements of hepatic fat content before and after C-pap
11191850|NCT02134522|FG000|Participant Flow|C-pap Intervention|Subjects who underwent measurement of the hepatic fat content before and after the C-pap
11376012|NCT01711541|FG003|Participant Flow|Dose Level 2|ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376013|NCT01711541|FG004|Participant Flow|Dose Level 3|ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376014|NCT01711541|OG000|Outcome|Dose Level 0|ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF induction.
11376015|NCT01711541|OG001|Outcome|Dose Level 0B|ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376016|NCT01711541|OG002|Outcome|Dose Level 1|ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376017|NCT01711541|OG003|Outcome|Dose Level 2|ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376018|NCT01711541|OG004|Outcome|Dose Level 3|ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376019|NCT01711541|OG000|Outcome|Arm I (Veliparib, Combination Chemotherapy)|"Patients receive veliparib PO BID on days 1-7, paclitaxel IV over 60 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then continue on to concomitant chemoradiotherapy.~Carboplatin: Given IV~Cisplatin: Given IV~Fluorouracil: Given IV~Hydroxyurea: Given PO~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Radiation Therapy: Undergo radiation therapy~Veliparib: Given PO"
11376020|NCT01711541|OG001|Outcome|Arm II (Placebo, Combination Chemotherapy)|"Patients receive placebo PO BID on days 1-7. Patients also receive paclitaxel and carboplatin as in Phase I. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Within 10 days from completion of course 2, patients begin concomitant chemoradiotherapy.~Carboplatin: Given IV~Cisplatin: Given IV~Fluorouracil: Given IV~Hydroxyurea: Given PO~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Placebo: Given PO~Radiation Therapy: Undergo radiation therapy"
11376021|NCT01711541|OG000|Outcome|Dose Level 0|ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction.
11376022|NCT01711541|OG000|Outcome|Arm I (Veliparib, Combination Chemotherapy)|Patients receive veliparib PO BID on days 1-7, paclitaxel IV over 60 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then continue on to concomitant chemoradiotherapy.
11376023|NCT01711541|OG001|Outcome|Arm II (Placebo, Combination Chemotherapy)|Patients receive placebo PO BID on days 1-7. Patients also receive paclitaxel and carboplatin as in Phase I. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Within 10 days from completion of course 2, patients begin concomitant chemoradiotherapy.
11376024|NCT01711541|EG000|Reported Event|Dose Level 0|ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction.
11376025|NCT01711541|EG001|Reported Event|Dose Level 0B|ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376026|NCT01711541|EG002|Reported Event|Dose Level 1|ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376027|NCT01711541|EG003|Reported Event|Dose Level 2|ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376028|NCT01711541|EG004|Reported Event|Dose Level 3|ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
11376029|NCT01696994|BG000|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
11376030|NCT01696994|BG001|Baseline|Ovarian Screening|Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376031|NCT01696994|BG002|Baseline|Total|Total of all reporting groups
11376032|NCT01696994|FG000|Participant Flow|Control|Participants receive standard medical care.
11376033|NCT01696994|FG001|Participant Flow|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376034|NCT01696994|OG000|Outcome|Control|Participants receive standard medical care.
11376035|NCT01696994|OG001|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376036|NCT01696994|OG001|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376037|NCT01696994|OG000|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376038|NCT01696994|OG000|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376039|NCT01696994|EG000|Reported Event|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
11376040|NCT01696981|BG000|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
11376041|NCT01696981|BG001|Baseline|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
11376042|NCT01696981|BG002|Baseline|Total|Total of all reporting groups
11376043|NCT01696981|FG000|Participant Flow|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
11376044|NCT01696981|FG001|Participant Flow|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
11376045|NCT01696981|OG000|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
11376046|NCT01696981|OG001|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
11191851|NCT02134522|OG000|Outcome|C-pap Intervention|Subjects who underwent the measure of hepatic fat content before and after the C-pap
11191852|NCT02134522|EG000|Reported Event|C-PAP Intervention|"Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.~Continuous positive airway pressure (CPAP).: Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults."
11376047|NCT01696981|OG000|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
11376048|NCT01696981|EG000|Reported Event|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
11376049|NCT01696968|BG000|Baseline|Control|Participants receive standard medical care.
11376050|NCT01696968|BG001|Baseline|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376051|NCT01696968|BG002|Baseline|Total|Total of all reporting groups
11376052|NCT01696968|FG000|Participant Flow|Control|Participants receive standard medical care.
11376053|NCT01696968|FG001|Participant Flow|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376054|NCT01696968|OG000|Outcome|Control|Participants receive standard medical care.
11376055|NCT01696968|OG001|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376056|NCT01696968|OG001|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376057|NCT01696968|OG000|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376058|NCT01696968|EG000|Reported Event|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
11376059|NCT01553149|BG000|Baseline|Arm I (Low-dose Lenalidomide)|"Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376060|NCT01553149|BG001|Baseline|Arm II (High-dose Lenalidomide)|"Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376061|NCT01553149|BG002|Baseline|Total|Total of all reporting groups
11376062|NCT01553149|FG000|Participant Flow|Arm I (Low-dose Lenalidomide)|"Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376063|NCT01553149|FG001|Participant Flow|Arm II (High-dose Lenalidomide)|"Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376064|NCT01553149|OG000|Outcome|Arm I (Low-dose Lenalidomide)|"Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376065|NCT01553149|OG001|Outcome|Arm II (High-dose Lenalidomide)|"Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376066|NCT01553149|EG000|Reported Event|Arm I (Low-dose Lenalidomide)|"Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376067|NCT01553149|EG001|Reported Event|Arm II (High-dose Lenalidomide)|"Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies"
11376068|NCT01544335|BG000|Baseline|Bioimpedance Spectroscopy|"Subjects evaluated using Bioimpedance Spectroscopy~Bioimpedance Spectroscopy: BIS used to measure fluid in arm"
11376069|NCT01544335|FG000|Participant Flow|Bioimpedance Sprectroscopy|"Subjects evaluated using Bioimpedance Spectroscopy~Bioimpedance Spectroscopy: BIS used to measure fluid in arm"
11376070|NCT01544335|OG000|Outcome|Bioimpedance Sprectroscopy|"Subjects evaluated using Bioimpedance Spectroscopy~Bioimpedance Spectroscopy: BIS used to measure fluid in arm"
11376071|NCT01544335|EG000|Reported Event|Bioimpedance Spectroscopy|"Subjects evaluated using Bioimpedance Spectroscopy~Bioimpedance Spectroscopy: BIS used to measure fluid in arm"
11376072|NCT01522976|BG000|Baseline|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
11376073|NCT01522976|BG001|Baseline|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
11376074|NCT01522976|BG002|Baseline|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
11376075|NCT01522976|BG003|Baseline|Total|Total of all reporting groups
11376076|NCT01522976|FG000|Participant Flow|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
11376077|NCT01522976|FG001|Participant Flow|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
11376078|NCT01522976|FG002|Participant Flow|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
11376079|NCT01522976|OG000|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
11376080|NCT01522976|OG001|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
11376081|NCT01522976|OG002|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
11376082|NCT01522976|OG000|Outcome|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
11376083|NCT01522976|OG001|Outcome|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
11376084|NCT01522976|OG002|Outcome|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
11376085|NCT01522976|EG000|Reported Event|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
11376086|NCT01522976|EG001|Reported Event|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
11376087|NCT01522976|EG002|Reported Event|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
11376088|NCT01468896|BG000|Baseline|Arm 1 (Phase 1)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
11376089|NCT01468896|BG001|Baseline|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
11376090|NCT01468896|BG002|Baseline|Total|Total of all reporting groups
11376091|NCT01468896|FG000|Participant Flow|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
11376092|NCT01468896|FG001|Participant Flow|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
11376093|NCT01468896|OG000|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
11376094|NCT01468896|OG001|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
11376095|NCT01468896|OG000|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
11376096|NCT01468896|EG000|Reported Event|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
11376097|NCT01468896|EG001|Reported Event|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
11376098|NCT01451515|BG000|Baseline|Stratum 1|"Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma~Patients should not have:~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts)~Overt testicular involvement (evidenced by ultrasonogram)."
11376099|NCT01451515|BG001|Baseline|Stratum 2|"MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma~Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3~Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3"
11376100|NCT01451515|BG002|Baseline|Stratum 3|Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
11376101|NCT01451515|BG003|Baseline|Total|Total of all reporting groups
11376102|NCT01451515|FG000|Participant Flow|Stratum 1|"Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma~Patients should not have:~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts)~Overt testicular involvement (evidenced by ultrasonogram)."
11376103|NCT01451515|FG001|Participant Flow|Stratum 2|"MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma~Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3~Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3"
11376104|NCT01451515|FG002|Participant Flow|Stratum 3|Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
11376105|NCT01451515|OG000|Outcome|Stratum 1|"Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma~Patients should not have:~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts)~Overt testicular involvement (evidenced by ultrasonogram)."
11376106|NCT01451515|OG001|Outcome|Stratum 2|"MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma~Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3~Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3"
11376107|NCT01451515|OG002|Outcome|Stratum 3|Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
11376108|NCT01451515|OG003|Outcome|All Enrollments|Twenty-three (23) eligible patients
11376109|NCT01451515|OG001|Outcome|Stratum 2|"MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma~Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3~Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3"
11376110|NCT01451515|EG000|Reported Event|Stratum 1|"Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma~Patients should not have:~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts)~Overt testicular involvement (evidenced by ultrasonogram)."
11376111|NCT01451515|EG001|Reported Event|Stratum 2|"MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma~Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma~Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3~Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3"
11376112|NCT01451515|EG002|Reported Event|Stratum 3|Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
11376113|NCT01451515|EG003|Reported Event|All Enrollments|Twenty-three (23) eligible patients
11376114|NCT01420926|BG000|Baseline|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376115|NCT01420926|BG001|Baseline|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376116|NCT01420926|BG002|Baseline|Total|Total of all reporting groups
11376117|NCT01420926|FG000|Participant Flow|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376118|NCT01420926|FG001|Participant Flow|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376119|NCT01420926|OG000|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376120|NCT01420926|OG001|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376121|NCT01420926|EG000|Reported Event|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376122|NCT01420926|EG001|Reported Event|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
11376123|NCT01413399|BG000|Baseline|Intra-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
11376124|NCT01413399|BG001|Baseline|Post-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
11376125|NCT01413399|BG002|Baseline|Total|Total of all reporting groups
11376126|NCT01413399|FG000|Participant Flow|Intra-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
11376127|NCT01413399|FG001|Participant Flow|Post-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
11376128|NCT01413399|OG000|Outcome|Intra-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
11376129|NCT01413399|OG001|Outcome|Post-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
11376130|NCT01413399|EG000|Reported Event|Intra-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
11376131|NCT01413399|EG001|Reported Event|Post-Arrest Therapeutic Hypothermia|4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
11376132|NCT01386385|BG000|Baseline|Phase I 40mg Veliparib Cohort|Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO
11376133|NCT01386385|BG001|Baseline|Phase I 80mg Veliparib Cohort|Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO
11191210|NCT02131272|OG000|Outcome|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191211|NCT02131272|OG001|Outcome|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191212|NCT02131272|EG000|Reported Event|Insulin Detemir + Metformin + Diet/Exercise|Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191213|NCT02131272|EG001|Reported Event|Insulin NPH + Metformin + Diet/Exercise|Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
11191214|NCT02131311|BG000|Baseline|Pessary|disposable, single-use pessary
11191215|NCT02131311|FG000|Participant Flow|Pessary|disposable, single-use pessary
11191216|NCT02131311|OG000|Outcome|Pessary|"disposable, single-use pessary~disposable, single-use pessary"
11191217|NCT02131311|OG000|Outcome|Pessary|disposable, single-use pessary
11191218|NCT02131311|EG000|Reported Event|Pessary|disposable, single-use pessary
11191219|NCT02131324|BG000|Baseline|DFD06|DFD06 Active
11191220|NCT02131324|BG001|Baseline|Comp01|Comp01 Comparator
11191221|NCT02131324|BG002|Baseline|Total|Total of all reporting groups
11191222|NCT02131324|FG000|Participant Flow|Comp01|"applied twice a day for 15 days~Comp01"
11191223|NCT02131324|FG001|Participant Flow|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
11191224|NCT02131324|OG000|Outcome|Clobetasol Propionate Cream, 0.05%|"applied twice a day for 15 days~Clobetasol Propionate Cream, 0.05%"
11191225|NCT02131324|OG001|Outcome|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
11191226|NCT02131324|EG000|Reported Event|Clobetasol Propionate Cream, 0.05%|"applied twice a day for 15 days~Clobetasol Propionate Cream 0.05%"
11191227|NCT02131324|EG001|Reported Event|DFD06 Cream|"applied twice a day for 15 days~DFD06 Cream"
11376134|NCT01386385|BG002|Baseline|Phase I 120mg Veliparib Cohort|Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO
11376135|NCT01386385|BG003|Baseline|Arm I (RT, Veliparib, Carboplatin, Paclitaxel)|"Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Veliparib: Given PO"
11376136|NCT01386385|BG004|Baseline|Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel)|"Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Placebo Administration: Given PO"
11376137|NCT01386385|BG005|Baseline|Total|Total of all reporting groups
11376138|NCT01386385|FG000|Participant Flow|Phase I 40 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT
11376139|NCT01386385|FG001|Participant Flow|Phase I Consolidation 40mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles
11376140|NCT01386385|FG002|Participant Flow|Phase I 80 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT
11376141|NCT01386385|FG003|Participant Flow|Phase I Consolidation 80mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376142|NCT01386385|FG004|Participant Flow|Phase I 120 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT.
11376143|NCT01386385|FG005|Participant Flow|Phase I Consolidation 120mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376144|NCT01386385|FG006|Participant Flow|Phase II Arm I (RT, Veliparib, Carboplatin, Paclitaxel)|"Participants undergo 3D-CRT and receive 120mg veliparib, carboplatin, and paclitaxel~During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles."
11376145|NCT01386385|FG007|Participant Flow|Phase II Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel)|"Participants undergo 3D-CRT and receive placebo PO BID, carboplatin and paclitaxel.~During consolidation, participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles."
11376146|NCT01386385|OG000|Outcome|Phase I 40mg Veliparib|"During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks.~During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles."
11376147|NCT01386385|OG001|Outcome|Phase I 80mg Veliparib|"During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks.~During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles."
11376148|NCT01386385|OG002|Outcome|Phase I 120mg Veliparib|"During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks.~During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles."
11376149|NCT01386385|OG000|Outcome|Arm I (RT, Veliparib, Carboplatin, Paclitaxel)|"Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Veliparib: Given PO"
11376150|NCT01386385|OG001|Outcome|Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel)|"Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Placebo Administration: Given PO"
11376151|NCT01386385|OG000|Outcome|Arm I Concurrent Chemoradiation (Veliparib, 3D-CRT, Carboplati|"Participants undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO"
11376152|NCT01386385|OG001|Outcome|Arm II Concurrent Chemoradiation (Placebo, 3D-CRT, Carboplatin|"Participants undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, participants receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.~3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Placebo Administration: Given PO"
11376153|NCT01386385|OG002|Outcome|Arm I Consolidation (Veliparib, Carboplatin, Paclitaxel)|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376154|NCT01386385|OG003|Outcome|Arm II Consolidation (Placebo, Carboplatin, Paclitaxel)|Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376155|NCT01386385|EG000|Reported Event|Phase I 40 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy
11376156|NCT01386385|EG001|Reported Event|Phase I 80 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy
11376157|NCT01386385|EG002|Reported Event|Phase I 120 mg Veliparib Cohort|Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy
11376158|NCT01386385|EG003|Reported Event|Phase II Arm I (Veliparib, 3D-CRT, Carboplatin, Paclitaxel)|Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy
11376159|NCT01386385|EG004|Reported Event|Phase II Arm II (Placebo, 3D-CRT, Carboplatin, Paclitaxel)|Participants undergo 3D-CRT and receive placebo, carboplatin, and paclitaxel during concurrent radiotherapy
11376160|NCT01386385|EG005|Reported Event|Phase I Consolidation 40mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376161|NCT01386385|EG006|Reported Event|Phase I Consolidation 80mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376162|NCT01386385|EG007|Reported Event|Phase I Consolidation 120mg Cohort|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376163|NCT01386385|EG008|Reported Event|Phase II Arm I Consolidation|Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376164|NCT01386385|EG009|Reported Event|Phase II Arm II Consolidation|Participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
11376165|NCT01371981|BG000|Baseline|Arm A|"INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5.~IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9.~SCT:~: pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2.~Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis."
11377042|NCT00346164|BG002|Baseline|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
10851469|NCT00306527|OG002|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
11191853|NCT02134587|BG000|Baseline|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
11377184|NCT03850444|OG001|Outcome|Chemotherapy (SOC Treatment)-China Extension|Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11377185|NCT03850444|EG000|Reported Event|Pembrolizumab-China Extension|Participants received pembrolizumab 200 mg by IV infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles)
11377186|NCT03850444|EG001|Reported Event|Chemotherapy (SOC Treatment)-China Extension|Participants received carboplatin at target dose Area Under the Curve (AUC 5) (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
10847196|NCT00282256|FG000|Participant Flow|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
11377187|NCT03794089|BG000|Baseline|Brief Anxiety Intervention|"Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management~Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills"
11191228|NCT02131402|BG000|Baseline|Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
11191229|NCT02131402|FG000|Participant Flow|Overall Participants Flow|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye."
11191230|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
11191231|NCT02131402|OG001|Outcome|Omafilcon A|Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
11376166|NCT01371981|BG001|Baseline|Arm B|"IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.~IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.~INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.~SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis."
11376167|NCT01371981|BG002|Baseline|Arm C (Cohort 1)|"IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.~INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.~INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.~Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.~MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year."
11376168|NCT01371981|BG003|Baseline|Arm C (Cohort 2)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).~IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.~INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.~INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.~Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year."
11376169|NCT01371981|BG004|Baseline|Arm C (Cohort 3)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.~IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.~INT I: Pts receive cytarabine IT & AE as in Arm A, INT II, & sorafenib tosylate PO daily days 6-28.~INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.~Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year."
11376170|NCT01371981|BG005|Baseline|Arm D|INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
11376171|NCT01371981|BG006|Baseline|Total|Total of all reporting groups
11376172|NCT01371981|FG000|Participant Flow|Arm A|"INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days 1-5.~IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days 2,9.~SCT:~pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2.~Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis."
11377188|NCT03794089|BG001|Baseline|Usual PC-MHI Care|"Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care~Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic"
11377189|NCT03794089|BG002|Baseline|Total|Total of all reporting groups
11191232|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.
11376173|NCT01371981|FG001|Participant Flow|Arm B|"IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.~IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.~INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.~SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis."
11376174|NCT01371981|FG002|Participant Flow|Arm C (Cohort 1)|"IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.~INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.~INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.~Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.~MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year."
11376175|NCT01371981|FG003|Participant Flow|Arm C (Cohort 2)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).~IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.~INT I: Pts receive cytarabine IT and AE as in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.~INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.~Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year."
11377190|NCT03794089|FG000|Participant Flow|Brief Anxiety Intervention|"Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management~Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills"
11191233|NCT02131402|OG001|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2
11191234|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
11191235|NCT02131402|OG001|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
11191236|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).
11191237|NCT02131402|OG001|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).
11191238|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
11191239|NCT02131402|OG001|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
11191240|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Participants surveyed at insertion.
11191241|NCT02131402|OG001|Outcome|Methafilcon A|Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.
11191242|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
11191243|NCT02131402|OG001|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
11191244|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2
11191245|NCT02131402|OG001|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.
11191246|NCT02131402|OG001|Outcome|Methafilcon A|Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
11191247|NCT02131402|OG000|Outcome|Enfilcon A|Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
11191248|NCT02131402|OG001|Outcome|Omafilcon A|Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
11191249|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.
11191250|NCT02131402|OG001|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.
11191251|NCT02131402|OG000|Outcome|Enfilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye
11191252|NCT02131402|OG001|Outcome|Methafilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.
11191253|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.
11191254|NCT02131402|OG001|Outcome|Ocufilcon D|Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.
11191255|NCT02131402|OG000|Outcome|Enfilcon A|Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.
11191256|NCT02131402|OG001|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.
11191257|NCT02131402|OG000|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
11376176|NCT01371981|FG004|Participant Flow|Arm C (Cohort 3)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.~IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.~INT I: Pts receive cytarabine IT & AE as in Arm A, INT II, & sorafenib tosylate PO daily days 6-28.~INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.~Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year."
11376177|NCT01371981|FG005|Participant Flow|Arm D|INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
11376178|NCT01371981|OG000|Outcome|Arm A|"INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5.~IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9.~SCT:~: pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2.~Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis."
11376179|NCT01371981|OG001|Outcome|Arm B|"IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.~IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.~INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.~SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis."
11376180|NCT01371981|OG000|Outcome|Arm C (Cohort 1)|"IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.~INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.~INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.~Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.~MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year."
11376181|NCT01371981|OG000|Outcome|Arm C (Cohort 2)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).~IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.~INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.~INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.~Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year."
11376182|NCT01371981|OG000|Outcome|Arm C (Cohort 3)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.~IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.~INT I: Pts receive cytarabine IT & AE as in Arm A, INT II, & sorafenib tosylate PO daily days 6-28.~INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.~Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year."
11376183|NCT01371981|OG002|Outcome|Arm C (Cohort 1)|"IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.~INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.~INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.~Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.~MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year."
11191258|NCT02131402|OG001|Outcome|Omafilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.
11191259|NCT02131402|OG000|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye
11376184|NCT01371981|OG003|Outcome|Arm C (Cohort 2)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).~IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.~INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.~INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.~Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year."
11376185|NCT01371981|OG004|Outcome|Arm C (Cohort 3)|"IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.~IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.~INT I: Pts receive cytarabine IT & AE as in Arm A, INT II, & sorafenib tosylate PO daily days 6-28.~INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.~Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year."
11376186|NCT01371981|OG005|Outcome|Arm D|INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
11376187|NCT01371981|OG000|Outcome|Arm B|"IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.~IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.~INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.~SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis."
11376188|NCT01371981|OG000|Outcome|Arm C|"Arm C (Cohort 1) IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE chemotherapy as Arm A, Intensification II; sorafenib tosylate PO INT II:cytarabine IT; MA chemotherapy as Arm A, Induction II (HR patients); sorafenib tosylate PO.~SCT (HR pts w/ matched family [MFD] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis.~MAINTENANCE:sorafenib tosylate PO~Arm C (Cohort 2 and 3) IND I:cytarabine IT; ADE as Arm A, IND I; sorafenib tosylate PO IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE as Arm A, INT II, & sorafenib tosylate PO INT II:cytarabine IT; MA as Arm A, IND II (HR patients); sorafenib tosylate PO. SCT (HR pts w/ matched family [MFD] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis.~MAINTENANCE:sorafenib tosylate PO"
11376189|NCT01371981|EG000|Reported Event|Arm A|"INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5.~IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9.~SCT:~: pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2.~Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis."
11376190|NCT01371981|EG001|Reported Event|Arm B|"IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.~IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.~INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.~SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis."
11376191|NCT01371981|EG002|Reported Event|Arm C (Cohort 1)|"IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.~INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.~INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.~SCT (HR patients with matched family [MFD] or unrelated donor):~Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.~Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.~MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year."
10851470|NCT00306527|OG003|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
10847197|NCT00282256|OG000|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
11191260|NCT02131402|OG001|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
11191261|NCT02131402|OG000|Outcome|Enfilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
11191262|NCT02131402|OG001|Outcome|Methafilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
11191263|NCT02131402|OG000|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
11191264|NCT02131402|OG001|Outcome|Omafilcon A|Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.
11191265|NCT02131402|OG001|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.
11191266|NCT02131402|OG000|Outcome|Enfilcon A|Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
11191267|NCT02131402|OG001|Outcome|Methafilcon A|Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.
11191268|NCT02131402|OG000|Outcome|Enfilcon A|Assessed after 1 hour post settling wearing Enfilcon A in one eye.
11191269|NCT02131402|OG001|Outcome|Omafilcon A|Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye
11191270|NCT02131402|OG000|Outcome|Enfilcon A|Assessed after 1 hour post settling, wearing Enfilcon A in one eye.
11191271|NCT02131402|OG001|Outcome|Ocufilcon D|Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.
10963123|NCT00870363|OG002|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10963124|NCT00870363|OG003|Outcome|HIV Negative Controls Not on ART|HIV-negative
10964018|NCT00875433|EG000|Reported Event|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
11377191|NCT03794089|FG001|Participant Flow|Usual PC-MHI Care|"Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care~Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic"
10851471|NCT00306527|OG004|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
11191272|NCT02131402|OG000|Outcome|Enfilcon A|Assessed at 1 hour post settling, wearing Enfilcon A in one eye.
11191273|NCT02131402|OG001|Outcome|Methafilcon A|Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
10847198|NCT00282256|EG000|Reported Event|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
11191274|NCT02131402|OG001|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
11191275|NCT02131402|OG000|Outcome|Enfilcon A|Surveyed after insertion at baseline, wearing Enfilcon A in one eye.
11191276|NCT02131402|OG001|Outcome|Ocufilcon D|Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.
11191277|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye.
11191278|NCT02131402|OG001|Outcome|Methafilcon A|Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.
11191279|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed after 1 hour wearing Enfilcon A in one eye.
11191280|NCT02131402|OG001|Outcome|Omafilcon A|Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.
11191281|NCT02131402|OG000|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
11191282|NCT02131402|OG001|Outcome|Ocufilcon D|Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.
10964019|NCT00875485|BG000|Baseline|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
11191283|NCT02131402|OG001|Outcome|Methafilcon A|Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
11191284|NCT02131402|OG000|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
11191285|NCT02131402|OG001|Outcome|Omafilcon A|Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
11191286|NCT02131402|OG001|Outcome|Ocufilcon D|Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
11191287|NCT02131402|OG001|Outcome|Methafilcon A|Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
11191288|NCT02131402|EG000|Reported Event|Enfilcon A / Omafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye."
11377192|NCT03794089|OG000|Outcome|Brief Anxiety Intervention|"Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management~Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills"
10963125|NCT00870363|EG000|Reported Event|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
10964020|NCT00875485|BG001|Baseline|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
10964021|NCT00875485|BG002|Baseline|Total|Total of all reporting groups
10964022|NCT00875485|FG000|Participant Flow|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
11191289|NCT02131402|EG001|Reported Event|Enfilcon A / Ocufilcon D|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye."
11191290|NCT02131402|EG002|Reported Event|Enfilcon A / Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
11191291|NCT02131532|BG000|Baseline|Intervention Group|Baseline characteristics of eight participants who completed all treatment sessions
11191292|NCT02131532|FG000|Participant Flow|Psychological Intervention|All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
10849994|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849995|NCT00299494|EG000|Reported Event|Inotuzumab Ozogamicin 0.8 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10964023|NCT00875485|FG001|Participant Flow|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
10849996|NCT00299494|EG001|Reported Event|Inotuzumab Ozogamicin 1.3 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
11191293|NCT02131532|OG000|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
10849997|NCT00299494|EG002|Reported Event|Inotuzumab Ozogamicin 1.8 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10851472|NCT00306527|OG005|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
10964024|NCT00875485|OG000|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
11191294|NCT02131532|OG000|Outcome|Intervention Group|This outcome presents the recruitment process. However, only eight participants who completed all treatment sessions were included for further analysis of clinical outcomes.
11191295|NCT02131532|EG000|Reported Event|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
11192340|NCT02138240|OG000|Outcome|Social Network Intervention|"Individuals will be recruited and trained to be Peer Educators who will participate in group sessions and then communicate this information with members of their social network (Sidekick) and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide.~Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB."
11192341|NCT02138240|EG000|Reported Event|Social Network Intervention|"Individuals will be recruited and trained to be Peer Educators who will participate in group sessions and then communicate this information with members of their social network (Sidekick) and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide.~Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB."
11192342|NCT02138253|BG000|Baseline|IDN-6556|"IDN-6556 25 mg BID~IDN-6556"
11192343|NCT02138253|BG001|Baseline|Placebo|"Placebo BID~Placebo: Placebo control"
11342756|NCT03715452|FG000|Participant Flow|DyeVert™ Plus Contrast Reduction System|"DyeVert Plus Contrast Reduction System~The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient."
11342757|NCT03715452|OG000|Outcome|DyeVert Plus Contrast Reduction System|"DyeVert Plus Contrast Reduction System~DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient."
11342758|NCT03715452|EG000|Reported Event|DyeVert Plus Contrast Reduction System|"DyeVert Plus Contrast Reduction System~DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient."
10966550|NCT00887510|FG001|Participant Flow|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
11192344|NCT02138253|BG002|Baseline|Total|Total of all reporting groups
11192345|NCT02138253|FG000|Participant Flow|IDN-6556|"IDN-6556 25 mg BID~IDN-6556"
11192346|NCT02138253|FG001|Participant Flow|Placebo|"Placebo BID~Placebo: Placebo control"
11192347|NCT02138253|OG000|Outcome|IDN-6556|"IDN-6556 25 mg BID~IDN-6556"
11192348|NCT02138253|OG001|Outcome|Placebo|"Placebo BID~Placebo: Placebo control"
11192349|NCT02138253|EG000|Reported Event|IDN-6556|"IDN-6556 25 mg BID~IDN-6556"
11192350|NCT02138253|EG001|Reported Event|Placebo|"Placebo BID~Placebo: Placebo control"
11192351|NCT02138461|BG000|Baseline|Bimatoprost|These patients take bimatoprost topically for glaucoma.
11192352|NCT02138461|BG001|Baseline|Latanoprost Group|These patients take latanoprost topically for glaucoma.
11192353|NCT02138461|BG002|Baseline|Total|Total of all reporting groups
11192354|NCT02138461|FG000|Participant Flow|Bimatoprost|These patients take bimatoprost topically for glaucoma.
11192355|NCT02138461|FG001|Participant Flow|Latanoprost Group|These patients take latanoprost topically for glaucoma.
11192356|NCT02138461|OG000|Outcome|Bimatoprost|These patients take bimatoprost topically for glaucoma.
11192357|NCT02138461|OG001|Outcome|Latanoprost Group|These patients take latanoprost topically for glaucoma.
11192358|NCT02138461|EG000|Reported Event|Bimatoprost|These patients take bimatoprost topically for glaucoma.
11192359|NCT02138461|EG001|Reported Event|Latanoprost Group|These patients take latanoprost topically for glaucoma.
11192360|NCT02138578|BG000|Baseline|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
11342759|NCT03715530|BG000|Baseline|Pregnant Subjects|"These are pregnant women that are admitted to Labor &Delivery (L&D) or an outpatient in the Women's Health Clinic that are being evaluated for rupture of membranes.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342760|NCT03715530|BG001|Baseline|Pregnant Controls|"These women will be found primarily in the Women's Health Clinic, when being seen for their routine antepartum appointments. Most of them will be recruited at about 36 weeks, since they will be having a pelvic exam at this time, as part of their routine antepartum care.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342761|NCT03715530|BG002|Baseline|Non Pregnant Controls|"These women will be found in the Women's Health Clinic, when being seen for gynecology appointments. Nursing staff and the dashboard will help to identify those patients who will be having a pelvic exam.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342762|NCT03715530|BG003|Baseline|Total|Total of all reporting groups
11342763|NCT03715530|FG000|Participant Flow|Pregnant Subjects|"These are pregnant women that are admitted to Labor &Delivery (L&D) or an outpatient in the Women's Health Clinic that are being evaluated for rupture of membranes.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342764|NCT03715530|FG001|Participant Flow|Pregnant Controls|"These women will be found primarily in the Women's Health Clinic, when being seen for their routine antepartum appointments. Most of them will be recruited at about 36 weeks, since they will be having a pelvic exam at this time, as part of their routine antepartum care.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342765|NCT03715530|FG002|Participant Flow|Non Pregnant Controls|"These women will be found in the Women's Health Clinic, when being seen for gynecology appointments. Nursing staff and the dashboard will help to identify those patients who will be having a pelvic exam.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342766|NCT03715530|OG000|Outcome|Pregnant Subjects|"These are pregnant women that are admitted to Labor &Delivery (L&D) or an outpatient in the Women's Health Clinic that are being evaluated for rupture of membranes.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342767|NCT03715530|OG001|Outcome|Pregnant Controls|"These women will be found primarily in the Women's Health Clinic, when being seen for their routine antepartum appointments. Most of them will be recruited at about 36 weeks, since they will be having a pelvic exam at this time, as part of their routine antepartum care.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
10966551|NCT00887510|OG000|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
11243282|NCT02501928|OG001|Outcome|Fesoterodine 2 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11342768|NCT03715530|OG002|Outcome|Non Pregnant Controls|"These women will be found in the Women's Health Clinic, when being seen for gynecology appointments. Nursing staff and the dashboard will help to identify those patients who will be having a pelvic exam.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342769|NCT03715530|EG000|Reported Event|Pregnant Subjects|"These are pregnant women that are admitted to Labor &Delivery (L&D) or an outpatient in the Women's Health Clinic that are being evaluated for rupture of membranes.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342770|NCT03715530|EG001|Reported Event|Pregnant Controls|"These women will be found primarily in the Women's Health Clinic, when being seen for their routine antepartum appointments. Most of them will be recruited at about 36 weeks, since they will be having a pelvic exam at this time, as part of their routine antepartum care.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342771|NCT03715530|EG002|Reported Event|Non Pregnant Controls|"These women will be found in the Women's Health Clinic, when being seen for gynecology appointments. Nursing staff and the dashboard will help to identify those patients who will be having a pelvic exam.~PAMG-1 immunoassay: The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip."
11342772|NCT03715803|BG000|Baseline|Calistar A|"Calistar A mesh to treat anterior and apical POP~Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses"
11342773|NCT03715803|BG001|Baseline|Calistar S|"Calistar S mesh to treat anterior and apical POP~Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses"
11342774|NCT03715803|BG002|Baseline|Total|Total of all reporting groups
11342775|NCT03715803|FG000|Participant Flow|Calistar A|"Calistar A mesh to treat anterior and apical POP~Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses"
11342776|NCT03715803|FG001|Participant Flow|Calistar S|"Calistar S mesh to treat anterior and apical POP~Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses"
11342777|NCT03715803|OG000|Outcome|Calistar A|"Calistar A mesh to treat anterior and apical POP~Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses"
11342778|NCT03715803|OG001|Outcome|Calistar S|"Calistar S mesh to treat anterior and apical POP~Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses"
11342779|NCT03715803|EG000|Reported Event|Calistar A|"Calistar A mesh to treat anterior and apical POP~Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses"
11342780|NCT03715803|EG001|Reported Event|Calistar S|"Calistar S mesh to treat anterior and apical POP~Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses"
11342781|NCT03716024|BG000|Baseline|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342782|NCT03716024|BG001|Baseline|Linezolid|Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342783|NCT03716024|BG002|Baseline|Total|Total of all reporting groups
11342784|NCT03716024|FG000|Participant Flow|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342785|NCT03716024|FG001|Participant Flow|Linezolid|Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342786|NCT03716024|OG000|Outcome|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342787|NCT03716024|OG001|Outcome|Linezolid|Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342788|NCT03716024|EG000|Reported Event|Omadacycline|Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342789|NCT03716024|EG001|Reported Event|Linezolid|Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
11342790|NCT03716050|BG000|Baseline|Group 1|"Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.~No treatment: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment."
11342791|NCT03716050|BG001|Baseline|Group 2|"Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream."
11342792|NCT03716050|BG002|Baseline|Group 3|"Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342793|NCT03716050|BG003|Baseline|Group 4|"Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342794|NCT03716050|BG004|Baseline|Group 5|"Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342795|NCT03716050|BG005|Baseline|Group 6|"Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342796|NCT03716050|BG006|Baseline|Group 7|"Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342797|NCT03716050|BG007|Baseline|Group 8|"Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342798|NCT03716050|BG008|Baseline|Total|Total of all reporting groups
11342799|NCT03716050|FG000|Participant Flow|Group 1|"Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.~No treatment: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment."
11342800|NCT03716050|FG001|Participant Flow|Group 2|"Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream."
11342801|NCT03716050|FG002|Participant Flow|Group 3|"Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342802|NCT03716050|FG003|Participant Flow|Group 4|"Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342803|NCT03716050|FG004|Participant Flow|Group 5|"Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11192361|NCT02138578|BG001|Baseline|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
11192362|NCT02138578|BG002|Baseline|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
11342804|NCT03716050|FG005|Participant Flow|Group 6|"Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342805|NCT03716050|FG006|Participant Flow|Group 7|"Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342806|NCT03716050|FG007|Participant Flow|Group 8|"Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342807|NCT03716050|OG000|Outcome|Group 1|"Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.~No treatment: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment."
11342808|NCT03716050|OG001|Outcome|Group 2|"Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream."
11342809|NCT03716050|OG002|Outcome|Group 3|"Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342810|NCT03716050|OG003|Outcome|Group 4|"Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
10966552|NCT00887510|OG001|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
11192363|NCT02138578|BG003|Baseline|Total|Total of all reporting groups
11192364|NCT02138578|FG000|Participant Flow|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
11192365|NCT02138578|FG001|Participant Flow|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
11192366|NCT02138578|FG002|Participant Flow|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
11192367|NCT02138578|OG000|Outcome|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
11342811|NCT03716050|OG004|Outcome|Group 5|"Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342812|NCT03716050|OG005|Outcome|Group 7|"Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342813|NCT03716050|OG006|Outcome|Group 8|"Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342814|NCT03716050|EG000|Reported Event|Group 1|"Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.~No treatment: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment."
11342815|NCT03716050|EG001|Reported Event|Group 2|"Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream."
11342816|NCT03716050|EG002|Reported Event|Group 3|"Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
11342817|NCT03716050|EG003|Reported Event|Group 4|"Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy."
10964075|NCT00875667|OG001|Outcome|Investigators Choice|Participants received a single agent investigators choice (IC) of chlorambucil 40 mg/m^2 PO every 28 days until progressive disease (PD) or toxicity, OR rituximab 375 mg/m^2 by intravenous (IV) infusion on days 1, 8, 15 and 22 of each 56-day treatment cycle until PD or toxicity, OR cytarabine 1-2 g/m^2 by IV infusion on days 1 and 2 of each 28 day treatment cycle; up to 6 cycles, OR gemcitabine 1000 mg/m^2 by IV infusion on days 1, 8 and 15 of each 28 day treatment cycle; up to 6 cycles OR oral fludarabine 40 mg/m^2 or IV fludarabine 25 mg/m^2 on days 1 through 5 of each 28-day cycle; up to 6 cycles. Participants were given the option to enter into the lenalidomide crossover phase if PD occurred and received lenalidomide 25 mg capsules daily on days 1 to 21 of each 28 day treatment cycle until PD or toxicity.
10964076|NCT00875667|EG000|Reported Event|Lenalidomide|Participants received lenalidomide 25 mg capsules orally every day for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity. Participants with moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min received 10 mg lenalidomide for 21 days of each 28-day cycle (Cycles 1 and 2). After Cycle 2, if the participant remained free of Grade 3 or Grade 4 toxicity, the dose was increased to 15 mg lenalidomide for 21 days of each 28-day treatment cycle until disease progression or unacceptable toxicity.
10964077|NCT00875667|EG001|Reported Event|Investigator's Choice|Participants received a single agent investigators choice (IC) of chlorambucil 40 mg/m^2 PO every 28 days until progressive disease (PD) or toxicity, OR rituximab 375 mg/m^2 by intravenous (IV) infusion on days 1, 8, 15 and 22 of each 56-day treatment cycle until PD or toxicity, OR cytarabine 1-2 g/m^2 by IV infusion on days 1 and 2 of each 28 day treatment cycle; up to 6 cycles, OR gemcitabine 1000 mg/m^2 by IV infusion on days 1, 8 and 15 of each 28 day treatment cycle; up to 6 cycles OR oral fludarabine 40 mg/m^2 or IV fludarabine 25 mg/m^2 on days 1 through 5 of each 28-day cycle; up to 6 cycles. Participants were given the option to enter into the lenalidomide crossover phase if PD occurred and received lenalidomide 25 mg capsules daily on days 1 to 21 of each 28 day treatment cycle until PD or toxicity.
10964078|NCT00875706|BG000|Baseline|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
10964079|NCT00875706|BG001|Baseline|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
10964080|NCT00875706|BG002|Baseline|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
11342818|NCT03716050|EG004|Reported Event|Group 5|"Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342819|NCT03716050|EG005|Reported Event|Group 6|"Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342820|NCT03716050|EG006|Reported Event|Group 7|"Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342821|NCT03716050|EG007|Reported Event|Group 8|"Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.~Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.~Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.~Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography."
11342822|NCT03716076|BG000|Baseline|Participant Receives 50 mcg of Carbetocin Post-delivery.|"Participant receives 50 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342823|NCT03716076|BG001|Baseline|Participant Receives 100 mcg of Carbetocin Post-delivery.|"Participant receives 100 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11192368|NCT02138578|OG001|Outcome|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
11342824|NCT03716076|BG002|Baseline|Total|Total of all reporting groups
11342825|NCT03716076|FG000|Participant Flow|Participant Receives 50 mcg of Carbetocin Post-delivery.|"Participant receives 50 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342826|NCT03716076|FG001|Participant Flow|Participant Receives 100 mcg of Carbetocin Post-delivery.|"Participant receives 100 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342827|NCT03716076|OG000|Outcome|Participant Receives 50 mcg of Carbetocin Post-delivery.|"Participant receives 50 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342828|NCT03716076|OG001|Outcome|Participant Receives 100 mcg of Carbetocin Post-delivery.|"Participant receives 100 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342829|NCT03716076|EG000|Reported Event|Participant Receives 50 mcg of Carbetocin Post-delivery.|"Participant receives 50 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342830|NCT03716076|EG001|Reported Event|Participant Receives 100 mcg of Carbetocin Post-delivery.|"Participant receives 100 mcg of carbetocin post-delivery.~Carbetocin: 50 mcg or 100 mcg bolus of carbetocin"
11342831|NCT03717012|BG000|Baseline|Nintedanib 150 mg|Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
11342832|NCT03717012|BG001|Baseline|Nintedanib 150 mg + Pulmonary Rehabilitation|"Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.~In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards."
11342833|NCT03717012|BG002|Baseline|Total|Total of all reporting groups
10800428|NCT00433511|BG000|Baseline|Arm A (Chemo + Placebo)|Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
10964081|NCT00875706|BG003|Baseline|Total|Total of all reporting groups
11342834|NCT03717012|FG000|Participant Flow|Nintedanib 150 mg|Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
11342835|NCT03717012|FG001|Participant Flow|Nintedanib 150 mg + Pulmonary Rehabilitation|"Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.~In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards."
11342836|NCT03717012|OG000|Outcome|Nintedanib 150 mg|Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
11342837|NCT03717012|OG001|Outcome|Nintedanib 150 mg + Pulmonary Rehabilitation|"Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.~In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards."
11342838|NCT03717012|EG000|Reported Event|Nintedanib 150 mg|Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
11342839|NCT03717012|EG001|Reported Event|Nintedanib 150 mg + Pulmonary Rehabilitation|"Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.~In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards."
10966553|NCT00887510|EG000|Reported Event|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
10966554|NCT00887510|EG001|Reported Event|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
11240887|NCT02482675|FG005|Participant Flow|Milk, Then Glucose, Then Sodium Caseinate, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11192369|NCT02138578|OG002|Outcome|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
11192370|NCT02138578|EG000|Reported Event|Randomized SBRT|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.~SBRT"
11192371|NCT02138578|EG001|Reported Event|Randomized RFA|"Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.~RFA"
11342840|NCT03717051|BG000|Baseline|Intervention|"The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.~Nicotine replacement therapy (NRT) sampling: 1-week free NRT samples (patch or gum)~Medication counseling: Medication counseling"
11342841|NCT03717051|BG001|Baseline|Control|"The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.~Medication counseling: Medication counseling"
11342842|NCT03717051|BG002|Baseline|Total|Total of all reporting groups
11342843|NCT03717051|FG000|Participant Flow|Control|"The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.~Medication counseling: Medication counseling"
11342844|NCT03717051|FG001|Participant Flow|Intervention|"The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.~Nicotine replacement therapy (NRT) sampling: 1-week free NRT samples (patch or gum)~Medication counseling: Medication counseling"
11342845|NCT03717051|OG000|Outcome|Intervention|"The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.~Nicotine replacement therapy (NRT) sampling: 1-week free NRT samples (patch or gum)~Medication counseling: Medication counseling"
11342846|NCT03717051|OG001|Outcome|Control|"The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.~Medication counseling: Medication counseling"
11342847|NCT03717051|EG000|Reported Event|Intervention|"The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.~Nicotine replacement therapy (NRT) sampling: 1-week free NRT samples (patch or gum)~Medication counseling: Medication counseling"
11342848|NCT03717051|EG001|Reported Event|Control|"The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.~Medication counseling: Medication counseling"
11192372|NCT02138578|EG002|Reported Event|Non-Randomized SBRT|"Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.~SBRT"
11192373|NCT02138747|BG000|Baseline|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
11192374|NCT02138747|BG001|Baseline|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
11192375|NCT02138747|BG002|Baseline|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
11377234|NCT03457129|OG001|Outcome|Fycompa 3 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377235|NCT03457129|EG000|Reported Event|Fycompa 2 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377236|NCT03457129|EG001|Reported Event|Fycompa 3 Week Titration Intervals|"Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.~Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures."
11377237|NCT03358472|BG000|Baseline|Pembrolizumab + Epacadostat|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11377238|NCT03358472|BG001|Baseline|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
11377239|NCT03358472|BG002|Baseline|EXTREME|"EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.~Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week. Cisplatin administered intravenously every 3 weeks for </= 6 cycles. Carboplatin administered intravenously every 3 weeks for </= 6 cycles. 5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles."
11377240|NCT03358472|BG003|Baseline|Total|Total of all reporting groups
11377241|NCT03358472|FG000|Participant Flow|Pembrolizumab + Epacadostat|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
10966555|NCT00887549|BG000|Baseline|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
11377242|NCT03358472|FG001|Participant Flow|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
11377243|NCT03358472|FG002|Participant Flow|EXTREME|"EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.~Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week. Cisplatin administered intravenously every 3 weeks for </= 6 cycles. Carboplatin administered intravenously every 3 weeks for </= 6 cycles. 5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles."
11377244|NCT03358472|OG000|Outcome|Pembrolizumab + Epacadostat|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11377245|NCT03358472|OG001|Outcome|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
11377246|NCT03358472|OG002|Outcome|EXTREME|"EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.~Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week. Cisplatin administered intravenously every 3 weeks for </= 6 cycles. Carboplatin administered intravenously every 3 weeks for </= 6 cycles. 5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles."
11377247|NCT03358472|EG000|Reported Event|Pembrolizumab + Epacadostat|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11377248|NCT03358472|EG001|Reported Event|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
11192376|NCT02138747|BG003|Baseline|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
11192377|NCT02138747|BG004|Baseline|Total|Total of all reporting groups
11377249|NCT03358472|EG002|Reported Event|EXTREME|"EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.~Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week. Cisplatin administered intravenously every 3 weeks for </= 6 cycles. Carboplatin administered intravenously every 3 weeks for </= 6 cycles. 5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles."
11377250|NCT03281304|BG000|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 27 months. Participants were followed-up to 4 weeks after the last dose.
11377251|NCT03281304|BG001|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 27 months. Participants were followed-up 4 to weeks after the last dose.
11377252|NCT03281304|BG002|Baseline|Total|Total of all reporting groups
11377253|NCT03281304|FG000|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 27 months. Participants were followed-up to 4 weeks after the last dose.
11377254|NCT03281304|FG001|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 27 months. Participants were followed-up 4 to weeks after the last dose.
11377255|NCT03281304|OG000|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 27 months. Participants were followed-up to 4 weeks after the last dose.
11377256|NCT03281304|OG001|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 27 months. Participants were followed-up 4 to weeks after the last dose.
11377257|NCT03281304|EG000|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 27 months. Participants were followed-up to 4 weeks after the last dose.
11377258|NCT03281304|EG001|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 27 months. Participants were followed-up 4 to weeks after the last dose.
10966556|NCT00887549|FG000|Participant Flow|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
11192378|NCT02138747|FG000|Participant Flow|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
11192379|NCT02138747|FG001|Participant Flow|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
11192380|NCT02138747|FG002|Participant Flow|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
11192381|NCT02138747|FG003|Participant Flow|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
11377259|NCT03274804|BG000|Baseline|Study Treatment Arm|All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
11377260|NCT03274804|FG000|Participant Flow|Single Arm, Prospective, Open-label Trial|"Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle (d1, qd22) together with maraviroc administered perorally on day 1 to 21 of each cycle (d1-21; qd22).~Pembrolizumab: Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle (d1, qd22)~Maraviroc: Maraviroc will be administered perorally on day 1 to 21 of each cycle (d1-21; qd22)"
11377261|NCT03274804|OG000|Outcome|Single Arm, Prospective, Open-label Trial|All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
11377262|NCT03274804|OG000|Outcome|Study Treatment Arm|All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
11377263|NCT03274804|EG000|Reported Event|Study Treatment Arm|The primary safety analysis will be based on subjects who experienced toxicities as defined by the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0; Section 11.2). The attribution to drug, time-of-onset, duration of the event, its resolution, and any concomitant medications administered will be recorded.
11377264|NCT03197935|BG000|Baseline|Placebo and Chemotherapy|Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
11377265|NCT03197935|BG001|Baseline|Atezolizumab and Chemotherapy|Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
11377266|NCT03197935|BG002|Baseline|Total|Total of all reporting groups
11377267|NCT03197935|FG000|Participant Flow|Placebo and Chemotherapy|Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
11192382|NCT02138747|OG000|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
11377268|NCT03197935|FG001|Participant Flow|Atezolizumab and Chemotherapy|Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
11377269|NCT03197935|OG000|Outcome|Placebo and Chemotherapy|Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
11377270|NCT03197935|OG001|Outcome|Atezolizumab and Chemotherapy|Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
11377271|NCT03197935|OG000|Outcome|Atezolizumab and Chemotherapy|Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
11377272|NCT03197935|EG000|Reported Event|Atezolizumab + Nab-paclitaxel + AC|Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
11377273|NCT03197935|EG001|Reported Event|Placebo + Nab-paclitaxel + AC|Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.
11377274|NCT03190460|BG000|Baseline|Intervention|Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
11377275|NCT03190460|BG001|Baseline|Education|Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
11377276|NCT03190460|BG002|Baseline|Total|Total of all reporting groups
11377277|NCT03190460|FG000|Participant Flow|Intervention|Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
11377278|NCT03190460|FG001|Participant Flow|Education|Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
11377279|NCT03190460|OG000|Outcome|Intervention|Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
11377280|NCT03190460|OG001|Outcome|Education|Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
11192383|NCT02138747|OG001|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
11377281|NCT03190460|EG000|Reported Event|Intervention|Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
11377282|NCT03190460|EG001|Reported Event|Education|Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
11377283|NCT03164616|BG000|Baseline|T + D + SoC|"During chemotherapy (combination) stage:~Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377284|NCT03164616|BG001|Baseline|D + SoC|"During chemotherapy (combination) stage:~Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377285|NCT03164616|BG002|Baseline|SoC Alone|"During chemotherapy (combination) stage:~Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator."
11377286|NCT03164616|BG003|Baseline|Total|Total of all reporting groups
11377287|NCT03164616|FG000|Participant Flow|T + D + SoC|"During chemotherapy (combination) stage:~Patients received tremelimumab 75 milligrams (mg) + durvalumab 1500 mg combination therapy + SoC chemotherapy via intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377288|NCT03164616|FG001|Participant Flow|D + SoC|"During chemotherapy (combination) stage:~Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377289|NCT03164616|FG002|Participant Flow|SoC Alone|"During chemotherapy (combination) stage:~Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator."
11377290|NCT03164616|OG000|Outcome|D + SoC|"During chemotherapy (combination) stage:~Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377291|NCT03164616|OG001|Outcome|SoC Alone|"During chemotherapy (combination) stage:~Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator."
11243283|NCT02501928|OG002|Outcome|Fesoterodine 4 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11377292|NCT03164616|OG000|Outcome|T + D + SoC|"During chemotherapy (combination) stage:~Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377293|NCT03164616|OG001|Outcome|D + SoC|"During chemotherapy (combination) stage:~Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377294|NCT03164616|OG002|Outcome|SoC Alone|"During chemotherapy (combination) stage:~Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator."
11377295|NCT03164616|EG000|Reported Event|T + D + SoC|"During chemotherapy (combination) stage:~Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377296|NCT03164616|EG001|Reported Event|D + SoC|"During chemotherapy (combination) stage:~Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator."
11377297|NCT03164616|EG002|Reported Event|SoC Alone|"During chemotherapy (combination) stage:~Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.~The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).~Post-chemotherapy (maintenance) stage:~Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator."
11243284|NCT02501928|EG000|Reported Event|Cohort 1|Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
11243285|NCT02501928|EG001|Reported Event|Cohort 2|Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
11377298|NCT03120949|BG000|Baseline|Treatment Arm 1: OKZ 64 mg q4w + MTX|"Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377299|NCT03120949|BG001|Baseline|Treatment Arm 2: OKZ 64 mg q2w + MTX|"Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377300|NCT03120949|BG002|Baseline|Total|Total of all reporting groups
11377301|NCT03120949|FG000|Participant Flow|Treatment Arm 1: OKZ 64 mg q4w + MTX|"Olokizumab 64 mg subcutaneous (SC) q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377302|NCT03120949|FG001|Participant Flow|Treatment Arm 2: OKZ 64 mg q2w + MTX|"Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377303|NCT03120949|OG000|Outcome|Treatment Arm 1: OKZ 64 mg q4w + MTX|"Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377304|NCT03120949|OG001|Outcome|Treatment Arm 2: OKZ 64 mg q2w + MTX|"Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
10966557|NCT00887549|OG000|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
11243286|NCT02501928|EG002|Reported Event|Fesoterodine 8 mg Tablet|Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
11377305|NCT03120949|OG000|Outcome|Treatment Arm 1: OKZ 64 mg q4w + MTX|"Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.~Concomitant treatment: Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)~Folic acid ≥ 5 mg per week or equivalent"
11377306|NCT03120949|OG001|Outcome|Treatment Arm 2: OKZ 64 mg q2w + MTX|"Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.~Concomitant treatment: Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)~Folic acid ≥ 5 mg per week or equivalent"
11377307|NCT03120949|OG000|Outcome|OKZ 64 mg q4w|subjects receiving OKZ 64 mg q4w during the core study or OLE
11377308|NCT03120949|OG001|Outcome|OKZ 64 mg q2w|subjects receiving OKZ 64 mg q2w during the core study or OLE
11377309|NCT03120949|EG000|Reported Event|Treatment Arm 1: OKZ 64 mg q4w + MTX|"Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377310|NCT03120949|EG001|Reported Event|Treatment Arm 2: OKZ 64 mg q2w + MTX|"Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).~Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL."
11377311|NCT03119766|BG000|Baseline|Kolofort|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Kolofort: Oral administration"
11377312|NCT03119766|BG001|Baseline|Placebo|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Placebo: Oral administration"
11377313|NCT03119766|BG002|Baseline|Total|Total of all reporting groups
11377314|NCT03119766|FG000|Participant Flow|Kolofort|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Kolofort: Oral administration"
11377315|NCT03119766|FG001|Participant Flow|Placebo|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Placebo: Oral administration"
11377316|NCT03119766|OG000|Outcome|Kolofort|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Kolofort: Oral administration"
11377317|NCT03119766|OG001|Outcome|Placebo|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Placebo: Oral administration"
11377318|NCT03119766|EG000|Reported Event|Kolofort|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Kolofort: Oral administration"
11377319|NCT03119766|EG001|Reported Event|Placebo|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.~Placebo: Oral administration"
11377320|NCT03077698|BG000|Baseline|PrR (+) Subjects|Subjects noted at Screening to have PrR (+) tumors were enrolled into Treatment Period 1 (TP1) receiving Progestin Monotherapy. Subjects noted to have Progressive Disease rolled into Treatment Period 2 (TP2) and received combination therapy of Sodium Cridanimod and Progestin. PrR (+) subjects that had Disease Control or Stable Disease after 24 weeks of Monotherapy treatment were not eligible to participate in TP2 and were discontinued.
11377321|NCT03077698|BG001|Baseline|PrR(-) Subjects|Subjects with PrR(-) tumors at screening will be enrolled directly into Treatment Period 2 (TP2) receiving combination therapy of Sodium Cridanimod and Progestin.
11377322|NCT03077698|BG002|Baseline|Total|Total of all reporting groups
11377323|NCT03077698|FG000|Participant Flow|PrR (+) Subjects|Subjects noted at Screening to have PrR (+) tumors were enrolled into Treatment Period 1 (TP1) receiving Progestin Monotherapy. Subjects noted to have Progressive Disease rolled into Treatment Period 2 (TP2) and received combination therapy of Sodium Cridanimod and Progestin. PrR (+) subjects that had Disease Control or Stable Disease after 24 weeks of Monotherapy treatment were not eligible to participate in TP2 and were discontinued.
10966558|NCT00887549|EG000|Reported Event|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
10966559|NCT00887562|BG000|Baseline|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
10966560|NCT00887562|BG001|Baseline|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
11377324|NCT03077698|FG001|Participant Flow|PrR (-) Subjects|Subjects with PrR(-) tumors at screening will be enrolled directly into Treatment Period 2 (TP2) receiving combination therapy of Sodium Cridanimod and Progestin.
10966561|NCT00887562|BG002|Baseline|Placebo|"Placebo~Placebo: Placebo - No idebenone"
11377325|NCT03077698|OG000|Outcome|Sodium Cridanimod & Progestin Therapy|"Sodium Cridanimod and progestin therapy (megestrol acetate) combination~Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative.~progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod"
11377326|NCT03077698|EG000|Reported Event|Progestin Monotherapy|Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy.
11377327|NCT03077698|EG001|Reported Event|Sodium Cridanimod & Progestin Therapy|Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals.
11377328|NCT02911935|BG000|Baseline|Azithromycin|Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
11377329|NCT02911935|BG001|Baseline|Placebo|Participants orally received Azithromycin placebo daily for 14 days
11377330|NCT02911935|BG002|Baseline|Total|Total of all reporting groups
11377331|NCT02911935|FG000|Participant Flow|Azithromycin|Participants received Azithromycin 10 mg/kg/d orally for 7 days and 5 mg/kg/d orally for additional 7 days
11377332|NCT02911935|FG001|Participant Flow|Placebo|Participants received Azithromycin placebo orally daily for 14 days
11377333|NCT02911935|OG000|Outcome|Azithromycin|Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
11377334|NCT02911935|OG001|Outcome|Placebo|Participants orally received Azithromycin placebo daily for 14 days
11377335|NCT02911935|EG000|Reported Event|Azithromycin|Participants orally received azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
11377336|NCT02911935|EG001|Reported Event|Placebo|Participants orally received placebo daily for 14 days.
10966562|NCT00887562|BG003|Baseline|Total|Total of all reporting groups
10966563|NCT00887562|FG000|Participant Flow|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
10966564|NCT00887562|FG001|Participant Flow|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
11377337|NCT02874742|BG000|Baseline|Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)|Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligram (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377338|NCT02874742|BG001|Baseline|Randomized: Daratumumab+RVd (D-RVd)|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377339|NCT02874742|BG002|Baseline|Safety Run-in: D-RVD|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 (mg/kg) IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377340|NCT02874742|BG003|Baseline|Total|Total of all reporting groups
11377341|NCT02874742|FG000|Participant Flow|Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)|Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligram (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377342|NCT02874742|FG001|Participant Flow|Randomized: Daratumumab+RVd (D-RVd)|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377343|NCT02874742|FG002|Participant Flow|Safety Run-in: D-RVD|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 (mg/kg) IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
10966565|NCT00887562|FG002|Participant Flow|Placebo|"Placebo~Placebo: Placebo - No idebenone"
10966566|NCT00887562|OG000|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
10966567|NCT00887562|OG001|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
11377344|NCT02874742|OG000|Outcome|Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)|Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligram (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377345|NCT02874742|OG001|Outcome|Randomized: Daratumumab+RVd (D-RVd)|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377346|NCT02874742|OG002|Outcome|Safety Run-in: D-RVd|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 (mg/kg) IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377347|NCT02874742|EG000|Reported Event|Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)|Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligram (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377348|NCT02874742|EG001|Reported Event|Randomized: Daratumumab+RVd (D-RVd)|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377349|NCT02874742|EG002|Reported Event|Safety Run-in: D-RVD|Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 (mg/kg) IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. Long-term follow-up phase- all participants are followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
11377350|NCT02644525|BG000|Baseline|Placebo|5 subjects given placebo as a single dose
11377351|NCT02644525|BG001|Baseline|Imatinib 200mg|5 subjects given 200mg PO imatinib as a single dose
11377352|NCT02644525|BG002|Baseline|Imatinib 400mg|5 subjects given 400mg PO imatinib as a single dose
11377353|NCT02644525|BG003|Baseline|Imatinib 600mg|5 subjects given 600mg PO imatinib as a single dose
11377354|NCT02644525|BG004|Baseline|Total|Total of all reporting groups
11377355|NCT02644525|FG000|Participant Flow|Placebo|5 subjects given placebo as a single dose
11377356|NCT02644525|FG001|Participant Flow|Imatinib 200mg|Participants given a single dose of 200mg PO imatinib
11377357|NCT02644525|FG002|Participant Flow|Imatinib 400mg|Participants given a single dose of 400mg PO imatinib
11377358|NCT02644525|FG003|Participant Flow|Imatinib 600mg|Participants given a single dose of 600mg PO imatinib
11377359|NCT02644525|OG000|Outcome|Placebo|Single dose of placebo
11377360|NCT02644525|OG001|Outcome|Imatinib 200mg|Single dose of imatinib 200mg po
11377361|NCT02644525|OG002|Outcome|Imatinib 400mg|Single dose of imatinib 400mg po
11377362|NCT02644525|OG003|Outcome|Imatinib 600mg|Single dose of imatinib 600mg po
11377363|NCT02644525|EG000|Reported Event|Placebo|Single dose of placebo
11377364|NCT02644525|EG001|Reported Event|Imatinib 200mg|Single dose of imatinib 200mg po
11377365|NCT02644525|EG002|Reported Event|Imatinib 400mg|Single dose of imatinib 400mg po
11377366|NCT02644525|EG003|Reported Event|Imatinib 600mg|Single dose of imatinib 600mg po
11377367|NCT02610777|BG000|Baseline|Azacitidine 75 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377368|NCT02610777|BG001|Baseline|Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377369|NCT02610777|BG002|Baseline|Total|Total of all reporting groups
11377370|NCT02610777|FG000|Participant Flow|Azacitidine 75 mg/m^2|Azacitidine 75 milligram per square meter (mg/m^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377371|NCT02610777|FG001|Participant Flow|Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377372|NCT02610777|OG000|Outcome|Azacitidine 75 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377373|NCT02610777|OG001|Outcome|Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377374|NCT02610777|EG000|Reported Event|Azacitidine 75 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11377375|NCT02610777|EG001|Reported Event|Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2|Azacitidine 75 mg/m^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
11192384|NCT02138747|OG000|Outcome|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
11192385|NCT02138747|OG001|Outcome|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
10966568|NCT00887562|OG002|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
11192386|NCT02138747|OG002|Outcome|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
11192387|NCT02138747|OG003|Outcome|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
11192388|NCT02138747|EG000|Reported Event|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
11377376|NCT02557672|BG000|Baseline|Fresh Frozen Plasma|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.~Fresh frozen plasma (FFP): FFP"
11377377|NCT02557672|BG001|Baseline|Prothrombin Complex Concentrate|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.~Prothrombin complex concentrate (Human): PCC (Kcentra)"
11377378|NCT02557672|BG002|Baseline|Total|Total of all reporting groups
11377379|NCT02557672|FG000|Participant Flow|Fresh Frozen Plasma|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.~Fresh frozen plasma (FFP): FFP"
11377380|NCT02557672|FG001|Participant Flow|Prothrombin Complex Concentrate|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.~Prothrombin complex concentrate (PCC) (Human): PCC (Kcentra)"
11377381|NCT02557672|OG000|Outcome|Fresh Frozen Plasma|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.~Fresh frozen plasma (FFP): FFP"
11377382|NCT02557672|OG001|Outcome|Prothrombin Complex Concentrate|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.~Prothrombin complex concentrate (Human): PCC (Kcentra)"
11377383|NCT02557672|EG000|Reported Event|Fresh Frozen Plasma|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.~Fresh frozen plasma (FFP): FFP"
11377384|NCT02557672|EG001|Reported Event|Prothrombin Complex Concentrate|"After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT >10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.~Prothrombin complex concentrate (Human): PCC (Kcentra)"
10966569|NCT00887562|OG000|Outcome|900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
10966570|NCT00887562|OG001|Outcome|2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
11377385|NCT02524379|BG000|Baseline|Glyburide Treatment Arm|"Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.~Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury."
11377386|NCT02524379|FG000|Participant Flow|Glyburide Treatment Arm|"Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.~Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury."
11377387|NCT02524379|OG000|Outcome|Glyburide Treatment Arm|"Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.~Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury."
11377388|NCT02524379|EG000|Reported Event|Glyburide Treatment Arm|"Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.~Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury."
11377389|NCT02509312|BG000|Baseline|Ketorolac|"Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.~Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377390|NCT02509312|BG001|Baseline|Placebo|"Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.~Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377391|NCT02509312|BG002|Baseline|Total|Total of all reporting groups
11377392|NCT02509312|FG000|Participant Flow|Ketorolac|"Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.~Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377393|NCT02509312|FG001|Participant Flow|Placebo|"Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.~Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377394|NCT02509312|OG000|Outcome|Ketorolac|"Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.~Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377395|NCT02509312|OG001|Outcome|Placebo|"Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.~Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.~Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.~Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery."
11377396|NCT02509312|OG000|Outcome|Ketorolac|"Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours~Ketorolac: Patients in the experimental arm will receive ketorolac 30 mg in 1 ml at the time of cord clamp and then for 3 more doses every 6 hours."
11377397|NCT02509312|OG001|Outcome|Placebo|"Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.~Normal Saline: Patients in the control arm will receive normal saline 1 ml at the time of cord clamp and then for 3 more doses every 6 hours."
11377398|NCT02509312|EG000|Reported Event|Ketorolac|"Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours~Ketorolac: Patients in the experimental arm will receive ketorolac 30 mg in 1 ml at the time of cord clamp and then for 3 more doses every 6 hours."
11377399|NCT02509312|EG001|Reported Event|Placebo|"Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.~Normal Saline: Patients in the control arm will receive normal saline 1 ml at the time of cord clamp and then for 3 more doses every 6 hours."
11377400|NCT02379247|BG000|Baseline|Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel|BYL-719 (alpelisib): 250mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377401|NCT02379247|BG001|Baseline|Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel|BYL-719 (alpelisib): 300mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377402|NCT02379247|BG002|Baseline|Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel|BYL-719 (alpelisib): 350mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377403|NCT02379247|BG003|Baseline|BYL-719/Alpelisib Dose Expansion|BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377404|NCT02379247|BG004|Baseline|Total|Total of all reporting groups
11377405|NCT02379247|FG000|Participant Flow|Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel|"BYL-719 (alpelisib): 250mg daily on day 1-28~Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)~BYL-719 (alpelisib): Oral PI3K inhibitor~Nab-paclitaxel: IV taxane"
11377406|NCT02379247|FG001|Participant Flow|Dose Level 2 BYL-719 (Alpelisib) (300mg)+Nab-paclitaxel|"BYL-719 (alpelisib): 300mg by mouth daily on day 1-28 of each 28 day cycle~Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)~BYL-719 (alpelisib): Oral PI3K inhibitor~Nab-paclitaxel: IV taxane"
11377407|NCT02379247|FG002|Participant Flow|Dose Level 3 BYL-719 (Alpelisib) (350mg)+Nab-paclitaxel|"BYL-719 (alpelisib): 350mg by mouth daily on day 1-28 of each 28 day cycle~Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)~BYL-719 (alpelisib): Oral PI3K inhibitor~Nab-paclitaxel: IV taxane"
11377408|NCT02379247|FG003|Participant Flow|BYL-719 (Alpelisib) Dose Expansion|"BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle~Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)~BYL-719 (alpelisib): Oral PI3K inhibitor~Nab-paclitaxel: IV taxane"
10966571|NCT00887562|EG000|Reported Event|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
11377409|NCT02379247|OG000|Outcome|Phase I|All patients in phase I, across all three dose levels of BYL-719 (alpelisib) + nab-paclitaxel
11377410|NCT02379247|OG000|Outcome|Participants Treated at the RP2D|Participants who were treated at the RP2D (350 mg BYL-719/alpelisib + 100 mg/m2 nab-paclitaxel) in either phase I or phase II.
11377411|NCT02379247|OG000|Outcome|All Evaluable Participants|All participants in phase I and phase II who were evaluable for response (i.e. received at least one cycle of study treatment)
11377412|NCT02379247|OG000|Outcome|Dose Level 1|Participants assigned to dose level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel
11377413|NCT02379247|OG001|Outcome|Dose Level 2|Participants assigned to Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel
11377414|NCT02379247|OG002|Outcome|Dose Level 3|Participants in phase I assigned to dose level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel
10966572|NCT00887562|EG001|Reported Event|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
10966573|NCT00887562|EG002|Reported Event|Placebo|"Placebo~Placebo: Placebo - No idebenone"
10966574|NCT00887575|BG000|Baseline|All Patients|Includes all patients treated at all dose levels
11377415|NCT02379247|OG001|Outcome|Dose Level 2|Participants assigned to dose level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel
11377416|NCT02379247|EG000|Reported Event|Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel|BYL-719 (alpelisib): 250mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377417|NCT02379247|EG001|Reported Event|Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel|BYL-719 (alpelisib): 300mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377418|NCT02379247|EG002|Reported Event|Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel|BYL-719 (alpelisib): 350mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377419|NCT02379247|EG003|Reported Event|BYL-719 (Alpelisib) Dose Expansion|BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
11377420|NCT02360280|BG000|Baseline|Six Ketamine Infusions|"Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.~ketamine: sedative"
11377421|NCT02360280|BG001|Baseline|Single Ketamine Infusion Preceded by 5 Midazolam Infusions|"Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.~ketamine: sedative~midazolam: sedative"
11377422|NCT02360280|BG002|Baseline|Total|Total of all reporting groups
11377423|NCT02360280|FG000|Participant Flow|Six Ketamine Infusions|"Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.~ketamine: sedative"
11377424|NCT02360280|FG001|Participant Flow|Single Ketamine Infusion Preceded by 5 Midazolam Infusions|"Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.~ketamine: sedative~midazolam: sedative"
11377425|NCT02360280|OG000|Outcome|Six Ketamine Infusions|"Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.~ketamine: sedative"
11377426|NCT02360280|OG001|Outcome|Single Ketamine Infusion Preceded by 5 Midazolam Infusions|"Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.~ketamine: sedative~midazolam: sedative"
11377427|NCT02360280|EG000|Reported Event|Six Ketamine Infusions|"Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.~ketamine: sedative"
11377428|NCT02360280|EG001|Reported Event|Single Ketamine Infusion Preceded by 5 Midazolam Infusions|"Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.~ketamine: sedative~midazolam: sedative"
11377429|NCT02294461|BG000|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
11377430|NCT02294461|BG001|Baseline|Placebo|Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).
11377431|NCT02294461|BG002|Baseline|Total|Total of all reporting groups
11377432|NCT02294461|FG000|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day during double blind period until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
11377433|NCT02294461|FG001|Participant Flow|Placebo|Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).
11377434|NCT02294461|OG000|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
11377435|NCT02294461|OG001|Outcome|Placebo|Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).
11377436|NCT02294461|OG001|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
11377437|NCT02294461|OG002|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
11377438|NCT02294461|OG003|Outcome|Enzalutamide Plus M2|Active metabolite
11377439|NCT02294461|OG003|Outcome|Enzalutamide Plus M2|
11377440|NCT02294461|OG001|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
11377441|NCT02294461|OG002|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
11377442|NCT02294461|OG003|Outcome|Enzalutamide Plus M2|Active metabolite.
11377443|NCT02294461|OG002|Outcome|M2- N-Desmethyl Enzalutamide|Active metabolite.
11377444|NCT02294461|OG000|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). This arm represents both double blind and open-label period.
11377445|NCT02294461|OG001|Outcome|Placebo|Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). This arm represents only double blind period.
11377446|NCT02294461|OG002|Outcome|Placebo Followed by Enzalutamide|Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). This arm represents only open-label period.
11377447|NCT02294461|EG000|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). This arm represents both double blind and open-label period.
11377448|NCT02294461|EG001|Reported Event|Placebo|Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). This arm represents only double blind period.
11377449|NCT02294461|EG002|Reported Event|Placebo Followed by Enzalutamide|Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). This arm represents only open-label period.
11377450|NCT02163395|BG000|Baseline|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
11377451|NCT02163395|FG000|Participant Flow|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
11377452|NCT02163395|OG000|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
11377453|NCT02163395|EG000|Reported Event|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
11377454|NCT02097134|BG000|Baseline|Melphalan|"Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Melphalan: Given IA"
11377455|NCT02097134|FG000|Participant Flow|Melphalan|"Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Melphalan: Given IA"
11377456|NCT02097134|OG000|Outcome|Melphalan|"Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Melphalan: Given IA"
11377457|NCT02097134|OG000|Outcome|Melphalan|Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
11377458|NCT02097134|EG000|Reported Event|Melphalan|"Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Melphalan: Given IA"
11377459|NCT02096588|BG000|Baseline|Simvastatin|"Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily. Treatment will start 7 days prior to the planned doxorubicin/cyclophosphamide chemotherapy initiation and will continue for a total of 25 weeks.~Simvastatin: Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377460|NCT02096588|BG001|Baseline|No Drug|"Participant not randomized to simvastatin will participate in all aspects of the study, including planned doxorubicin/cyclophosphamide chemotherapy, with the exception of simvastatin administration.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377461|NCT02096588|BG002|Baseline|Total|Total of all reporting groups
11377462|NCT02096588|FG000|Participant Flow|Simvastatin|"Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily. Treatment will start 7 days prior to the planned doxorubicin/cyclophosphamide chemotherapy initiation and will continue for a total of 25 weeks.~Simvastatin: Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377463|NCT02096588|FG001|Participant Flow|No Drug|"Participant not randomized to simvastatin will participate in all aspects of the study, including planned doxorubicin/cyclophosphamide chemotherapy, with the exception of simvastatin administration.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377464|NCT02096588|OG000|Outcome|Simvastatin|"Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily. Treatment will start 7 days prior to the planned doxorubicin/cyclophosphamide chemotherapy initiation and will continue for a total of 25 weeks.~Simvastatin: Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377465|NCT02096588|OG001|Outcome|No Drug|"Participant not randomized to simvastatin will participate in all aspects of the study, including planned doxorubicin/cyclophosphamide chemotherapy, with the exception of simvastatin administration.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377466|NCT02096588|EG000|Reported Event|Simvastatin|"Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily. Treatment will start 7 days prior to the planned doxorubicin/cyclophosphamide chemotherapy initiation and will continue for a total of 25 weeks.~Simvastatin: Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377467|NCT02096588|EG001|Reported Event|No Drug|"Participant not randomized to simvastatin will participate in all aspects of the study, including planned doxorubicin/cyclophosphamide chemotherapy, with the exception of simvastatin administration.~Doxorubicin/cyclophosphamide: The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician."
11377468|NCT02053350|BG000|Baseline|Alanyl-glutamine|"Alanyl-glutamine, 44g, taken by mouth daily for 10 days.~Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days"
11377469|NCT02053350|FG000|Participant Flow|Alanyl-glutamine|"Alanyl-glutamine, 44g, taken by mouth daily for 10 days.~Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days"
11377470|NCT02053350|OG000|Outcome|Alanyl-glutamine|"Alanyl-glutamine, 44g, taken by mouth daily for 10 days.~Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days"
11377471|NCT02053350|EG000|Reported Event|Alanyl-glutamine|"Alanyl-glutamine, 44g, taken by mouth daily for 10 days.~Alanyl-glutamine: Alanyl-glutamine, 44g, taken by mouth daily for 10 days"
11377472|NCT02005471|BG000|Baseline|Bendamustine + Rituximab|Participants received bendamustine at a dose of 70 mg/m^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377473|NCT02005471|BG001|Baseline|Venetoclax + Rituximab|Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377474|NCT02005471|BG002|Baseline|Total|Total of all reporting groups
11377475|NCT02005471|FG000|Participant Flow|Bendamustine + Rituximab|Participants received bendamustine at a dose of 70 milligrams per meter squared (mg/m^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377476|NCT02005471|FG001|Participant Flow|Venetoclax + Rituximab|Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 milligrams (mg) via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
10966575|NCT00887575|FG000|Participant Flow|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
11377477|NCT02005471|OG000|Outcome|Bendamustine + Rituximab|Participants received bendamustine at a dose of 70 mg/m^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377478|NCT02005471|OG001|Outcome|Venetoclax + Rituximab|Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377479|NCT02005471|OG000|Outcome|Bendamustine + Rituximab 17p Del. Population|Participants received bendamustine at a dose of 70 mg/m^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6. Only participants with 17p deletion as identified by FISH test were included.
11377480|NCT02005471|OG001|Outcome|Venetoclax + Rituximab 17p Del. Population|Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6. Only participants with 17p deletion as identified by FISH test were included.
11377481|NCT02005471|OG000|Outcome|Venetoclax + Rituximab|Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377482|NCT02005471|EG000|Reported Event|Bendamustine + Rituximab|Participants received bendamustine at a dose of 70 mg/m^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377483|NCT02005471|EG001|Reported Event|Venetoclax + Rituximab|Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
11377484|NCT01965704|BG000|Baseline|Ondansetron - Mothers|Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery; may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication.
10966576|NCT00887575|FG001|Participant Flow|Dose Level II|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
10966577|NCT00887575|FG002|Participant Flow|Dose Level III|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
11377485|NCT01965704|BG001|Baseline|Ondansetron - Neonates|Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days).
11377486|NCT01965704|BG002|Baseline|Placebo - Mothers|Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group); may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication.
11377487|NCT01965704|BG003|Baseline|Placebo - Neonates|Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).
11377488|NCT01965704|BG004|Baseline|Total|Total of all reporting groups
11377489|NCT01965704|FG000|Participant Flow|Ondansetron - Mothers|Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery; may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication.
11377490|NCT01965704|FG001|Participant Flow|Ondansetron - Neonates|Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days).
11377491|NCT01965704|FG002|Participant Flow|Placebo - Mothers|Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group); may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication.
11377492|NCT01965704|FG003|Participant Flow|Placebo - Neonates|Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).
11377493|NCT01965704|OG000|Outcome|Ondansetron - Neonates|Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days).
11377494|NCT01965704|OG001|Outcome|Placebo - Neonates|Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).
11377495|NCT01965704|EG000|Reported Event|Ondansetron - Mothers|Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery; may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication.
11377496|NCT01965704|EG001|Reported Event|Ondansetron - Neonates|Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days).
11377497|NCT01965704|EG002|Reported Event|Placebo - Mothers|Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group); may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication.
11377498|NCT01965704|EG003|Reported Event|Placebo - Neonates|Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).
11377499|NCT01913795|BG000|Baseline|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11377500|NCT01913795|BG001|Baseline|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
11377501|NCT01913795|BG002|Baseline|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11377502|NCT01913795|BG003|Baseline|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11377503|NCT01913795|BG004|Baseline|Total|Total of all reporting groups
11377504|NCT01913795|FG000|Participant Flow|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11377505|NCT01913795|FG001|Participant Flow|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
11377506|NCT01913795|FG002|Participant Flow|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11377507|NCT01913795|FG003|Participant Flow|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11377508|NCT01913795|OG000|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11377509|NCT01913795|OG001|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
11377510|NCT01913795|OG002|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11377511|NCT01913795|OG003|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11377512|NCT01913795|EG000|Reported Event|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11377513|NCT01913795|EG001|Reported Event|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
11377514|NCT01913795|EG002|Reported Event|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11377515|NCT01913795|EG003|Reported Event|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11377516|NCT01855412|BG000|Baseline|Claudication (Rutherford 2-3)|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377517|NCT01855412|BG001|Baseline|CLI Rutherford 4-5|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377518|NCT01855412|BG002|Baseline|CLI Rutherford 6|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377519|NCT01855412|BG003|Baseline|Total|Total of all reporting groups
11377520|NCT01855412|FG000|Participant Flow|Claudication (Rutherford 2-3)|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377521|NCT01855412|FG001|Participant Flow|CLI Rutherford 4-5|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377522|NCT01855412|FG002|Participant Flow|CLI Rutherford 6|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377523|NCT01855412|OG000|Outcome|Claudication (Rutherford 2-3)|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377524|NCT01855412|OG001|Outcome|CLI Rutherford 4-5|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377525|NCT01855412|OG002|Outcome|CLI Rutherford 6|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377526|NCT01855412|EG000|Reported Event|Claudication Rutherford 2-3 Procedure Through 30 Days|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377527|NCT01855412|EG001|Reported Event|CLI Rutherford 4-5 Procedure Through 30 Days|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377528|NCT01855412|EG002|Reported Event|CLI Rutherford 6 Procedure Through 30 Days|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice."
11377529|NCT01855412|EG003|Reported Event|Rutherford 2-3 31 Days - 365 Days Post-Procedure|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 31 Days - 365 Days Post-Procedure"
11377530|NCT01855412|EG004|Reported Event|CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 31 Days - 365 Days Post-Procedure"
11377531|NCT01855412|EG005|Reported Event|CLI Rutherford 6 31 Days - 365 Days Post-Procedure|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 31 Days - 365 Days Post-Procedure"
11377532|NCT01855412|EG006|Reported Event|Claudication Rutherford 2-3 366 Days Post-Procedure or Greater|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 366 Days Post-Procedure or Greater"
11377533|NCT01855412|EG007|Reported Event|CLI Rutherford 4-5 366 Days Post-Procedure or Greater|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 366 Days Post-Procedure or Greater"
11377534|NCT01855412|EG008|Reported Event|CLI Rutherford 6 366 Days Post-Procedure or Greater|"Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.~PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.~Adverse events occurring between 366 Days Post-Procedure or Greater"
10966578|NCT00887575|OG000|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
11377535|NCT01664182|BG000|Baseline|Arm I (Trebananib Monotherapy)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11377536|NCT01664182|BG001|Baseline|Arm II (Trebananib and Anti-VEGF Therapy)|"Patients receive trebananib as in Arm I and either bevacizumab IV over 30-90 minutes on days 1, 15, and 29, pazopanib hydrochloride PO QD on days 1-42, sorafenib tosylate PO BID on days 1-42, or sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Pazopanib Hydrochloride: Given PO~Sorafenib Tosylate: Given PO~Sunitinib Malate: Given PO~Trebananib: Given IV"
11377537|NCT01664182|BG002|Baseline|Total|Total of all reporting groups
11377538|NCT01664182|FG000|Participant Flow|Arm I (Trebananib Monotherapy)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11377539|NCT01664182|FG001|Participant Flow|Arm II (Trebananib and Anti-VEGF Therapy)|"Patients receive trebananib as in Arm I and either bevacizumab IV over 30-90 minutes on days 1, 15, and 29, pazopanib hydrochloride PO QD on days 1-42, sorafenib tosylate PO BID on days 1-42, or sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Pazopanib Hydrochloride: Given PO~Sorafenib Tosylate: Given PO~Sunitinib Malate: Given PO~Trebananib: Given IV"
11377540|NCT01664182|OG000|Outcome|Arm I (Trebananib Monotherapy)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11377541|NCT01664182|OG001|Outcome|Arm II (Trebananib and Anti-VEGF Therapy)|"Patients receive trebananib as in Arm I and either bevacizumab IV over 30-90 minutes on days 1, 15, and 29, pazopanib hydrochloride PO QD on days 1-42, sorafenib tosylate PO BID on days 1-42, or sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Pazopanib Hydrochloride: Given PO~Sorafenib Tosylate: Given PO~Sunitinib Malate: Given PO~Trebananib: Given IV"
11377542|NCT01664182|EG000|Reported Event|Arm I (Trebananib Monotherapy)|"Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Trebananib: Given IV"
11377543|NCT01664182|EG001|Reported Event|Arm II (Trebananib and Anti-VEGF Therapy)|"Patients receive trebananib as in Arm I and either bevacizumab IV over 30-90 minutes on days 1, 15, and 29, pazopanib hydrochloride PO QD on days 1-42, sorafenib tosylate PO BID on days 1-42, or sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Pazopanib Hydrochloride: Given PO~Sorafenib Tosylate: Given PO~Sunitinib Malate: Given PO~Trebananib: Given IV"
11377544|NCT01661881|BG000|Baseline|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9-176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity."
11377545|NCT01661881|FG000|Participant Flow|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9-176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity."
11377546|NCT01661881|OG000|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9-176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
11377547|NCT01661881|EG000|Reported Event|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9-176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.~Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
11377548|NCT01646814|BG000|Baseline|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
11377549|NCT01646814|BG001|Baseline|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
11377550|NCT01646814|BG002|Baseline|Total|Total of all reporting groups
11377551|NCT01646814|FG000|Participant Flow|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
11377552|NCT01646814|FG001|Participant Flow|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
11377553|NCT01646814|OG000|Outcome|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
11377554|NCT01646814|OG001|Outcome|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
11377555|NCT01646814|EG000|Reported Event|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
11377556|NCT01646814|EG001|Reported Event|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
11377557|NCT01621568|BG000|Baseline|Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2|Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
11377558|NCT01621568|BG001|Baseline|No Treatment: Weeks 5-6, Group 1; Week 3, Group 2|Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
11377559|NCT01621568|BG002|Baseline|Total|Total of all reporting groups
11377560|NCT01621568|FG000|Participant Flow|Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2|Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle)
11377561|NCT01621568|FG001|Participant Flow|No Treatment: Weeks 5-6, Group 1; Week 3, Group 2|Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
11377562|NCT01621568|OG000|Outcome|Group 1 (Thymoma Carcinoma) 50 mg/Day|Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
11377563|NCT01621568|OG001|Outcome|Group 1 (Thymic Carcinoma) 50 mg/Day|Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
11377564|NCT01621568|OG002|Outcome|Group 2 (Thymic Carcinoma Only) 50 mg/Day|Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
11377565|NCT01621568|OG000|Outcome|Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2|Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
11377566|NCT01621568|OG001|Outcome|No Treatment: Weeks 5-6, Group 1; Week 3, Group 2|Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
11377567|NCT01621568|EG000|Reported Event|Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2|Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
11377568|NCT01621568|EG001|Reported Event|No Treatment: Weeks 5-6, Group 1; Week 3, Group 2|Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
11377569|NCT01416636|BG000|Baseline|High Dose|Treprostinil sodium high dose
11377570|NCT01416636|BG001|Baseline|Low Dose|Treprostinil sodium low dose
11377571|NCT01416636|BG002|Baseline|Total|Total of all reporting groups
11377572|NCT01416636|FG000|Participant Flow|Treprostinil Sodium High Dose (~30ng/kg/Min)|Treprostinil sodium was administered subcutaneously via an ambulatory infusion pump with continuous flow rate. Patients were uptitrated to a target dose of approx. 30ng/kg/min within the first 12 weeks and were kept on stable dose for the remaining 12 weeks study duration.
11377573|NCT01416636|FG001|Participant Flow|Treprostinil Sodium Low Dose (~3ng/kg/Min)|Treprostinil sodium was administered subcutaneously via an ambulatory infusion pump with continuous flow rate. Patients were uptitrated to a target dose of approx. 3ng/kg/min within the first 12 weeks and were kept on stable dose for the remaining 12 weeks study duration.
11377574|NCT01416636|OG000|Outcome|High Dose|Treprostinil sodium high dose
11377575|NCT01416636|OG001|Outcome|Low Dose|Treprostinil sodium low dose
11377576|NCT01416636|EG000|Reported Event|High Dose|Treprostinil sodium high dose
11377577|NCT01416636|EG001|Reported Event|Low Dose|Treprostinil sodium low dose
11377578|NCT01070069|BG000|Baseline|SEVAR|Standard vascular exposure cutdown approach (SEVAR=Control).
11377579|NCT01070069|BG001|Baseline|PEVAR Perclose ProGlide|PEVAR performed with the Perclose ProGlide suture mediated closure system.
11377580|NCT01070069|BG002|Baseline|PEVAR Prostar XL|PEVAR performed with the Prostar XL suture mediated closure system.
11377581|NCT01070069|BG003|Baseline|PEVAR (Prostar XL Roll -In)|PEVAR performed with the Prostar XL suture mediated closure system.
11377582|NCT01070069|BG004|Baseline|PEVAR (ProGlide Roll -In)|PEVAR performed with the Prostar XL suture mediated closure system.
11377583|NCT01070069|BG005|Baseline|Total|Total of all reporting groups
11192389|NCT02138747|EG001|Reported Event|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
11192390|NCT02138786|BG000|Baseline|Selinexor 60 mg/m² (8 Doses/Cycle)|60 mg/m² oral dose twice weekly for Weeks 1-4
11377584|NCT01070069|FG000|Participant Flow|Standard EVAR (IntuiTrak)|"EVAR using standard vascular exposure for access~SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR"
11377585|NCT01070069|FG001|Participant Flow|PEVAR (ProGlide Closure)|"Percutaneous EVAR facilitated by the ProGlide closure device~PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device"
11377586|NCT01070069|FG002|Participant Flow|PEVAR (ProstarXL Closure)|"Percutaneous EVAR facilitated by the Prostar XL closure device~PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device"
11377587|NCT01070069|FG003|Participant Flow|PEVAR (Prostar XL Roll-In Phase)|"Percutaneous EVAR facilitated by the Prostar XL closure device~PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device"
11377588|NCT01070069|FG004|Participant Flow|PEVAR (ProGlide Roll-In Phase)|"Percutaneous EVAR facilitated by the ProGlide closure device~PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device"
11377589|NCT01070069|OG000|Outcome|Standard EVAR (IntuiTrak)|"EVAR using standard vascular exposure for access~SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR"
11377590|NCT01070069|OG001|Outcome|PEVAR (ProGlide Closure)|"Percutaneous EVAR facilitated by the ProGlide closure device~PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device"
11377591|NCT01070069|OG002|Outcome|PEVAR (ProstarXL Closure)|"Percutaneous EVAR facilitated by the Prostar XL closure device~PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device"
11377592|NCT01070069|OG003|Outcome|PEVAR (ProGlide Roll-in)|PEVAR performed with the ProGlide suture mediated closure system.
11377593|NCT01070069|OG004|Outcome|PEVAR (ProStar XL Roll-in)|PEVAR performed with the ProStar XL suture mediated closure system.
11377594|NCT01070069|OG004|Outcome|PEVAR (Prostar XL Roll-in)|PEVAR performed with the Prostar XL suture mediated closure system.
11377595|NCT01070069|OG003|Outcome|PEVAR (ProGlide Roll -In)|PEVAR performed with the ProGlide suture mediated closure system.
11192391|NCT02138786|BG001|Baseline|Selinexor 60 mg (6 Doses/Cycle)|60 mg oral dose twice weekly for Weeks 1-3
11192392|NCT02138786|BG002|Baseline|Selinexor 60 mg (8 Doses/Cycle)|60 mg oral dose twice weekly for Weeks 1-4
11192393|NCT02138786|BG003|Baseline|Total|Total of all reporting groups
11192394|NCT02138786|FG000|Participant Flow|Selinexor 60 mg/m² (8 Doses/Cycle)|60 mg/m² dose twice weekly for weeks 1-4
11192395|NCT02138786|FG001|Participant Flow|Selinexor 60 mg (6 Doses/Cycle)|60 mg oral dose twice weekly for weeks 1-3
11192396|NCT02138786|FG002|Participant Flow|Selinexor 60 mg (8 Doses/Cycle)|60 mg oral dose twice weekly for weeks 1-4
11192397|NCT02138786|OG000|Outcome|Selinexor|All dosing groups
11377596|NCT01070069|OG004|Outcome|PEVAR (Prostar XL Roll -In)|PEVAR performed with the Prostar XL suture mediated closure system.
11377597|NCT01070069|EG000|Reported Event|Standard EVAR (IntuiTrak)|"EVAR using standard vascular exposure for access~SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR"
11377598|NCT01070069|EG001|Reported Event|PEVAR (ProGlide Closure)|"Percutaneous EVAR facilitated by the ProGlide closure device~PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device"
11377599|NCT01070069|EG002|Reported Event|PEVAR (ProstarXL Closure)|"Percutaneous EVAR facilitated by the Prostar XL closure device~PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device"
11377600|NCT01070069|EG003|Reported Event|PEVAR (Prostar XL Roll -In)|PEVAR performed with the Prostar XL suture mediated closure system.
11377601|NCT01070069|EG004|Reported Event|PEVAR (ProGlide Roll -In)|PEVAR performed with the ProGlide suture mediated closure system.
11377602|NCT00775684|BG000|Baseline|Exenatide|"Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
11377603|NCT00775684|BG001|Baseline|Sitagliptin|"Sitagliptin (Januvia®)-100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
11377604|NCT00775684|BG002|Baseline|Glimepiride|"Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
11377605|NCT00775684|BG003|Baseline|Total|Total of all reporting groups
11377606|NCT00775684|FG000|Participant Flow|Exenatide|"Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
11377607|NCT00775684|FG001|Participant Flow|Sitagliptin|"Sitagliptin (Januvia®)-100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
11377608|NCT00775684|FG002|Participant Flow|Glimepiride|"Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
11377609|NCT00775684|OG000|Outcome|Exenatide|"Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
11377610|NCT00775684|OG001|Outcome|Sitagliptin|"Sitagliptin (Januvia®)-100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
11377611|NCT00775684|OG002|Outcome|Glimepiride|"Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
11377612|NCT00775684|OG000|Outcome|AIRarg Exenatide|Acute insulin response to arginine
11377613|NCT00775684|OG001|Outcome|AIRarg Sitagliptin|Acute insulin response to arginine
11377614|NCT00775684|OG002|Outcome|AIRarg Glimepiride|Acute insulin response to arginine
11377615|NCT00775684|OG000|Outcome|M/I Exenatide|Change in insulin sensitivity
11192398|NCT02138786|EG000|Reported Event|Selinexor 60 mg/m² (8 Doses/Cycle)|60 mg/m² oral dose twice weekly for Weeks 1-4
11377616|NCT00775684|OG001|Outcome|M/I Sitagliptin|Change in insulin sensitivity
11377617|NCT00775684|OG002|Outcome|M/I Glimepiride|Change in insulin sensitivity
11377618|NCT00775684|OG000|Outcome|P50 Exenatide|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
11377619|NCT00775684|OG001|Outcome|P50 Sitagliptin|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
11377620|NCT00775684|OG002|Outcome|P50 Glimepiride|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
11377621|NCT00775684|EG000|Reported Event|Exenatide|"Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
11377622|NCT00775684|EG001|Reported Event|Sitagliptin|"Sitagliptin (Januvia®)-100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
11377623|NCT00775684|EG002|Reported Event|Glimepiride|"Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
11377624|NCT00501046|BG000|Baseline|AST-120|AST-120: 9g /day (3 times a day)
11377625|NCT00501046|BG001|Baseline|Placebo|Placebo: 9g /day (3 times a day)
11377626|NCT00501046|BG002|Baseline|Total|Total of all reporting groups
11377627|NCT00501046|FG000|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
10966579|NCT00887575|OG000|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
11192399|NCT02138786|EG001|Reported Event|Selinexor 60 mg (6 Doses/Cycle)|60 mg oral dose twice weekly for Weeks 1-3
11192400|NCT02138786|EG002|Reported Event|Selinexor 60 mg (8 Doses/Cycle)|60 mg oral dose twice weekly for Weeks 1-4
11377628|NCT00501046|FG001|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
11377629|NCT00501046|OG000|Outcome|AST-120|AST-120: 9g /day (3 times a day)
11377630|NCT00501046|OG001|Outcome|Placebo|Placebo: 9g /day (3 times a day)
11377631|NCT00501046|EG000|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
11377632|NCT00501046|EG001|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
11377633|NCT00500682|BG000|Baseline|AST-120|AST-120: 9g /day (3 times a day)
11377634|NCT00500682|BG001|Baseline|Placebo|Placebo: 9g /day (3 times a day)
11377635|NCT00500682|BG002|Baseline|Total|Total of all reporting groups
11377636|NCT00500682|FG000|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
11377637|NCT00500682|FG001|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
11377638|NCT00500682|OG000|Outcome|AST-120|AST-120: 9g /day (3 times a day)
11377639|NCT00500682|OG001|Outcome|Placebo|Placebo: 9g /day (3 times a day)
11377640|NCT00500682|EG000|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
11377641|NCT00500682|EG001|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
11377642|NCT00334815|BG000|Baseline|Low Risk Patient Stratum|
11377643|NCT00334815|BG001|Baseline|High Risk Patient Stratum|
11377644|NCT00334815|BG002|Baseline|Total|Total of all reporting groups
11377645|NCT00334815|FG000|Participant Flow|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
11377646|NCT00334815|FG001|Participant Flow|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
11377647|NCT00334815|OG000|Outcome|Concurrent Chemotherapy and Radiotherapy|
11377648|NCT00334815|OG001|Outcome|Consolidation Therapy With Docetaxel and Bevacizumab.|
11377649|NCT00334815|OG000|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
11377650|NCT00334815|OG001|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
11377651|NCT00334815|EG000|Reported Event|Concurrent Chemotherapy and Radiotherapy|All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
11377652|NCT00334815|EG001|Reported Event|Consolidation Therapy With Docetaxel and Bevacizumab|All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
11377653|NCT00001277|BG000|Baseline|Primary Hyperparathyroidism - Incomplete Data|Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
11377654|NCT00001277|BG001|Baseline|Primary Hyperparathyroidism|Patients with confirmed or suspected primary hyperparathyroidism or complications
11377655|NCT00001277|BG002|Baseline|DOTATATE and F-DOPA|"Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA~68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.~18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors."
11377656|NCT00001277|BG003|Baseline|Total|Total of all reporting groups
11377657|NCT00001277|FG000|Participant Flow|Primary Hyperparathyroidism - Incomplete Data|Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
11377658|NCT00001277|FG001|Participant Flow|Primary Hyperparathyroidism|Patients with confirmed or suspected primary hyperparathyroidism or complications
11377659|NCT00001277|FG002|Participant Flow|DOTATATE and F-DOPA|"Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA~68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.~18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors."
11377660|NCT00001277|OG000|Outcome|Primary Hyperparathyroidism - Incomplete Data|Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
11377661|NCT00001277|OG001|Outcome|Primary Hyperparathyroidism|Patients with confirmed or suspected primary hyperparathyroidism or complications
11377662|NCT00001277|OG002|Outcome|DOTATATE and F-DOPA|"Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA~68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.~18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors."
11377663|NCT00001277|OG000|Outcome|DOTATATE and F-DOPA|Patients who received both DOTATATE and F-DOPA scans
11377664|NCT00001277|EG000|Reported Event|Primary Hyperparathyroidism - Incomplete Data|Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
11377665|NCT00001277|EG001|Reported Event|Primary Hyperparathyroidism|Patients with confirmed or suspected primary hyperparathyroidism or complications
11377666|NCT00001277|EG002|Reported Event|DOTATATE and F-DOPA|"Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA~68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.~18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors."
11377667|NCT01009294|BG000|Baseline|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, apple juice, or milk. Study drug dosing was based on milligrams of drug per kilogram of body weight. The dose level for ataluren was 20 mg/kg in the morning, 20 mg/kg at midday, and 40 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug was taken for up to 50 days.
11377668|NCT01009294|FG000|Participant Flow|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, apple juice, or milk. Study drug dosing was based on milligrams of drug per kilogram of body weight. The dose level for ataluren was 20 milligrams/kilograms (mg/kg) in the morning, 20 mg/kg at midday, and 40 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug was taken for up to 50 days.
11377669|NCT01009294|OG000|Outcome|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, apple juice, or milk. Study drug dosing was based on milligrams of drug per kilogram of body weight. The dose level for ataluren was 20 mg/kg in the morning, 20 mg/kg at midday, and 40 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug was taken for up to 50 days.
11377670|NCT01009294|EG000|Reported Event|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, apple juice, or milk. Study drug dosing was based on milligrams of drug per kilogram of body weight. The dose level for ataluren was 20 mg/kg in the morning, 20 mg/kg at midday, and 40 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug was taken for up to 50 days.
11377671|NCT01053637|BG000|Baseline|Intervention|Hydrocodone/acetaminophen suspension (taste/color-matched)
11377672|NCT01053637|BG001|Baseline|Placebo|Sugar solution
11377673|NCT01053637|BG002|Baseline|Total|Total of all reporting groups
11377674|NCT01053637|FG000|Participant Flow|Hydrocodone/Acetaminophen|"Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.~hydrocodone/acetaminophen: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered."
11377675|NCT01053637|FG001|Participant Flow|Sugar Water|"Placebo~Sugar water: An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug"
11377676|NCT01053637|OG000|Outcome|Hydrocodone/Acetaminophen|"Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.~hydrocodone/acetaminophen: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered."
11377677|NCT01053637|OG001|Outcome|Sugar Water|"Placebo~Sugar water: An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug"
11377678|NCT01053637|EG000|Reported Event|Hydrocodone/Acetaminophen|"Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.~hydrocodone/acetaminophen: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered."
11377679|NCT01053637|EG001|Reported Event|Sugar Water|"Placebo~Sugar water: An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug"
11377680|NCT01072175|BG000|Baseline|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
11377681|NCT01072175|BG001|Baseline|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
11377682|NCT01072175|BG002|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377683|NCT01072175|BG003|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377684|NCT01072175|BG004|Baseline|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
11377685|NCT01072175|BG005|Baseline|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
11377686|NCT01072175|BG006|Baseline|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
11377687|NCT01072175|BG007|Baseline|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
11377688|NCT01072175|BG008|Baseline|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377689|NCT01072175|BG009|Baseline|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377690|NCT01072175|BG010|Baseline|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377691|NCT01072175|BG011|Baseline|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377692|NCT01072175|BG012|Baseline|Total|Total of all reporting groups
11377693|NCT01072175|FG000|Participant Flow|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
11377694|NCT01072175|FG001|Participant Flow|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
11377695|NCT01072175|FG002|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377696|NCT01072175|FG003|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377697|NCT01072175|FG004|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
11377698|NCT01072175|FG005|Participant Flow|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
11377699|NCT01072175|FG006|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
11377700|NCT01072175|FG007|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
11377701|NCT01072175|FG008|Participant Flow|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
10966580|NCT00887575|EG000|Reported Event|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
11377702|NCT01072175|FG009|Participant Flow|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377703|NCT01072175|FG010|Participant Flow|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377704|NCT01072175|FG011|Participant Flow|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377705|NCT01072175|FG012|Participant Flow|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377706|NCT01072175|OG000|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
11377707|NCT01072175|OG001|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
11377708|NCT01072175|OG000|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
11377709|NCT01072175|OG001|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377710|NCT01072175|OG002|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377711|NCT01072175|OG003|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
11377712|NCT01072175|OG000|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
11377713|NCT01072175|OG001|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
11377714|NCT01072175|OG002|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
11377715|NCT01072175|OG000|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
11377716|NCT01072175|OG000|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377717|NCT01072175|OG001|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377718|NCT01072175|OG002|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377719|NCT01072175|OG003|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377720|NCT01072175|OG000|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
11377721|NCT01072175|OG000|Outcome|Part B: Dabrafenib + Trametinib|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib (75 mg or 150 mg) gelatin capsules BID and trametinib (1 mg, 1.5 mg, or 2 mg) tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
11377722|NCT01072175|OG001|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
11377723|NCT01072175|EG000|Reported Event|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
11377724|NCT01072175|EG001|Reported Event|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
11377725|NCT01072175|EG002|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377726|NCT01072175|EG003|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
11377727|NCT01072175|EG004|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
11377728|NCT01072175|EG005|Reported Event|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
11377729|NCT01072175|EG006|Reported Event|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
11377730|NCT01072175|EG007|Reported Event|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
11377731|NCT01072175|EG008|Reported Event|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
11377732|NCT01072175|EG009|Reported Event|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377733|NCT01072175|EG010|Reported Event|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
11377734|NCT01072175|EG011|Reported Event|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377735|NCT01072175|EG012|Reported Event|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
11377736|NCT01087203|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.
11377737|NCT01087203|BG001|Baseline|Tanezumab|Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.
11377738|NCT01087203|BG002|Baseline|Total|Total of all reporting groups
11377739|NCT01087203|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.
11377740|NCT01087203|FG001|Participant Flow|Tanezumab|Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.
11377741|NCT01087203|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.
11377742|NCT01087203|OG001|Outcome|Tanezumab|Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.
11377743|NCT01087203|OG000|Outcome|Tanezumab|Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.
11377744|NCT01087203|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.
11377745|NCT01087203|EG001|Reported Event|Tanezumab|Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.
11377750|NCT01108055|BG000|Baseline|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
11377751|NCT01108055|FG000|Participant Flow|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
11377752|NCT01108055|OG000|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
11377753|NCT01108055|EG000|Reported Event|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
11377754|NCT01111019|BG000|Baseline|r-hGH (Saizen®)|Subjects received a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose was subsequently reduced to 0.035 mg/kg/day for subjects, who continued treatment after 31 January 2011. Subjects were treated for at least 3 years or until near final height was reached.
11377755|NCT01111019|FG000|Participant Flow|r-hGH (Saizen®)|Subjects received a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose was subsequently reduced to 0.035 mg/kg/day for subjects, who continued treatment after 31 January 2011. Subjects were treated for at least 3 years or until near final height was reached.
11377756|NCT01111019|OG000|Outcome|r-hGH (Saizen®)|Subjects received a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose was subsequently reduced to 0.035 mg/kg/day for subjects, who continued treatment after 31 January 2011. Subjects were treated for at least 3 years or until near final height was reached.
11377757|NCT01111019|EG000|Reported Event|r-hGH (Saizen®)|Subjects received a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose was subsequently reduced to 0.035 mg/kg/day for subjects, who continued treatment after 31 January 2011. Subjects were treated for at least 3 years or until near final height was reached.
11377758|NCT01136967|BG000|Baseline|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377759|NCT01136967|BG001|Baseline|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377760|NCT01136967|BG002|Baseline|Total|Total of all reporting groups
11377761|NCT01136967|FG000|Participant Flow|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377762|NCT01136967|FG001|Participant Flow|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377763|NCT01136967|OG000|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377764|NCT01136967|OG001|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377765|NCT01136967|EG000|Reported Event|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377766|NCT01136967|EG001|Reported Event|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
11377746|NCT01088815|BG000|Baseline|Gemcitabine, Nab-paclitaxel, GDC-0449|"Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)~Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily"
11377747|NCT01088815|FG000|Participant Flow|Gemcitabine, Nab-paclitaxel, GDC-0449|"Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)~Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily"
11377748|NCT01088815|OG000|Outcome|Gemcitabine, Nab-paclitaxel, GDC-0449|"Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)~Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily"
11377749|NCT01088815|EG000|Reported Event|Gemcitabine, Nab-paclitaxel, GDC-0449|"Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)~Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily"
11377767|NCT01136980|BG000|Baseline|Sham Placebo Procedure|"Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.~Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus."
11377768|NCT01136980|BG001|Baseline|TIF Transoral Fundoplication|"Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.~TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)"
11377769|NCT01136980|BG002|Baseline|Total|Total of all reporting groups
11377770|NCT01136980|FG000|Participant Flow|Sham Placebo Procedure|"Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.~Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus."
11377771|NCT01136980|FG001|Participant Flow|TIF Transoral Fundoplication|"Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.~TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)"
11377772|NCT01136980|OG000|Outcome|Sham Placebo Procedure|"Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.~Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus."
11377773|NCT01136980|OG001|Outcome|TIF Transoral Fundoplication|"Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.~TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)"
11377774|NCT01136980|EG000|Reported Event|Sham Placebo Procedure|"Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.~Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus."
10800429|NCT00433511|BG001|Baseline|Arm B (Chemo + Bevacizumab)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
10966581|NCT00887588|BG000|Baseline|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
10849933|NCT00299182|FG004|Participant Flow|1 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11243287|NCT02501928|EG003|Reported Event|Fesoterodine 2 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
10800430|NCT00433511|BG002|Baseline|Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
10800431|NCT00433511|BG003|Baseline|Total|Total of all reporting groups
10966582|NCT00887588|BG001|Baseline|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
10966583|NCT00887588|BG002|Baseline|Total|Total of all reporting groups
11192401|NCT02138825|BG000|Baseline|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192402|NCT02138825|BG001|Baseline|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192403|NCT02138825|BG002|Baseline|Total|Total of all reporting groups
11192404|NCT02138825|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192405|NCT02138825|FG001|Participant Flow|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192406|NCT02138825|OG000|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192407|NCT02138825|OG001|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
11192408|NCT02138825|OG000|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
10964082|NCT00875706|FG000|Participant Flow|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm.~Educational Intervention: The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia."
11377775|NCT01136980|EG001|Reported Event|TIF Transoral Fundoplication|"Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.~TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)"
11377776|NCT01137955|BG000|Baseline|Rifaximin|Antibiotic ( 25 subjects) 400 mg capsules of Rifaximin 3 times a day for 10 days.
11377777|NCT01137955|BG001|Baseline|Placebo|Inert capsules ( 25 Subjects) Placebo capsules 3 times a day for 10 days.
11377778|NCT01137955|BG002|Baseline|Total|Total of all reporting groups
11377779|NCT01137955|FG000|Participant Flow|Rifaximin|"Antibiotic ( 25 subjects)~400 mg capsules of Rifaximin 3 times a day for 10 days."
11377780|NCT01137955|FG001|Participant Flow|Placebo|"Inert capsules ( 25 Subjects)~Placebo capsules 3 times a day for 10 days."
11377781|NCT01137955|OG000|Outcome|Rifaximin|400 mg capsules of Rifaximin 3 times a day for 10 days.
11377782|NCT01137955|OG001|Outcome|Placebo|Placebo capsules 3 times a day for 10 days.
11377783|NCT01137955|OG000|Outcome|Rifaximin 400mg|400 mg capsules of Rifaximin 3 times a day for 10 days.
11377784|NCT01137955|EG000|Reported Event|Rifaximin|Antibiotic: Rifaximin 400mg orally three times a day for 10 days total
11377785|NCT01137955|EG001|Reported Event|Placebo|Inert capsules: Placebo orally three times a day for 10 days total
10966584|NCT00887588|FG000|Participant Flow|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
10966585|NCT00887588|FG001|Participant Flow|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
11341074|NCT03674281|OG005|Outcome|Young Children: CLC|CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
10800432|NCT00433511|FG000|Participant Flow|Arm A (Chemo + Placebo)|Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
11192409|NCT02138825|OG000|Outcome|Riociguat up to 2.5 mg Tid|All participants that were initially randomized to Rioiciguat treatment were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
11192410|NCT02138825|OG001|Outcome|Placebo|All participants that were initially randomized to placebo were taken off study drug at the time of study termination, and started the 120 days safety follow-up phase, regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
11377786|NCT01140451|BG000|Baseline|Ataluren/Ataluren|Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
10964083|NCT00875706|FG001|Participant Flow|Data Collection - Survey|"Survey data collection tools were piloted to assess feasibility of survey administration and development for use in a long-term care setting. These tools were piloted in sites where the educational intervention was administered.~The survey was a modified version of the Care Coordination Survey which was originally validated in a hospital setting (citation below). The survey pertains to work context factors that shape practice, including staffing and resources, communication and IT, participation in decision-making, relationships with supervisors, professional empowerment, and relational coordination. Modifications were made for use of the survey in a VA Community Living Centers.~Weinberg, D., J. Perloff, D. Cooney-Miner, and E. Glaser, Supporting work and workers: Validation of a hospital work organization survey for professional and paraprofessional workers. 2008."
10964084|NCT00875706|FG002|Participant Flow|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
10964085|NCT00875706|OG000|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
10964086|NCT00875706|OG001|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
10964087|NCT00875706|OG002|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
10964088|NCT00875706|EG000|Reported Event|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
10964089|NCT00875706|EG001|Reported Event|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
10964090|NCT00875706|EG002|Reported Event|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
10964091|NCT00875797|BG000|Baseline|Parenteral Glutamine|parenteral glutamine supplementation
10964092|NCT00875797|BG001|Baseline|Enteral Glutamine|enteral glutamine supplementation
10964093|NCT00875797|BG002|Baseline|Total|Total of all reporting groups
10964094|NCT00875797|FG000|Participant Flow|Group P|Group P - group with parenterally supplemented glutamine
10964095|NCT00875797|FG001|Participant Flow|Group E|Group E - group with enterally supplemented glutamine
10964096|NCT00875797|OG000|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
10964097|NCT00875797|OG001|Outcome|Group E - Enteral Glutamine|Group E - group with enterally supplemented glutamine
10964098|NCT00875797|OG001|Outcome|Group - Enteral Glutamine|Group E - group with enterally supplemented glutamine
10964099|NCT00875797|OG000|Outcome|Group P - Parenteral Glutamine|parenteral glutamine supplementation
10964100|NCT00875797|OG001|Outcome|Group E - Enteral Glutamine|enteral glutamine supplementation
10964101|NCT00875797|EG000|Reported Event|Group P|Group P - group with parenterally supplemented glutamine
10964102|NCT00875797|EG001|Reported Event|Group E|Group E - group with enterally supplemented glutamine
10964103|NCT00875810|BG000|Baseline|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
10964104|NCT00875810|FG000|Participant Flow|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
10964105|NCT00875810|OG000|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
10964106|NCT00875810|EG000|Reported Event|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
10964107|NCT00875836|BG000|Baseline|Buspirone|Buspirone: 30 mg capsules twice daily
10964108|NCT00875836|BG001|Baseline|Placebo|Placebo: 30 mg capsules twice daily
10964109|NCT00875836|BG002|Baseline|Total|Total of all reporting groups
10964110|NCT00875836|FG000|Participant Flow|Buspirone|Buspirone: Flexible dose up to 60 mg/day
10964111|NCT00875836|FG001|Participant Flow|Placebo|Placebo: Flexible dose up to 60mg/day
10964112|NCT00875836|OG000|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
10964113|NCT00875836|OG001|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
10964114|NCT00875836|EG000|Reported Event|Buspirone|Buspirone: Flexible dose up to 60 mg/day
10800433|NCT00433511|FG001|Participant Flow|Arm B (Chemo + Bevacizumab)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
10800434|NCT00433511|FG002|Participant Flow|Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Within the following 2 months, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
10800435|NCT00433511|OG000|Outcome|Arm A (Chemo + Placebo)|Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
10800436|NCT00433511|OG001|Outcome|Arm B (Chemo + Bevacizumab)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
10800437|NCT00433511|OG002|Outcome|Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
10800438|NCT00433511|OG000|Outcome|European Ancestry|Genome-wide SNP arrays (either Illumina HumanOmni1-Quad or Human OmniExpress) were performed on germline DNA from whole blood to determine the genetic ancestry for the patients. The genetic ancestry is categorized into African ancestry (AA), European ancestry (EA) or other. Only African ancestry and European ancestry were included in these analyses.
10800439|NCT00433511|OG001|Outcome|African Ancestry|Genome-wide SNP arrays (either Illumina HumanOmni1-Quad or Human OmniExpress) were performed on germline DNA from whole blood to determine the genetic ancestry for the patients. The genetic ancestry is categorized into African ancestry (AA), European ancestry (EA) or other. Only African ancestry and European ancestry were included in these analyses.
10800440|NCT00433511|EG000|Reported Event|Arm A (Chemo + Placebo)|Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
10800441|NCT00433511|EG001|Reported Event|Arm B (Chemo + Bevacizumab)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
10849934|NCT00299182|FG005|Participant Flow|3 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849935|NCT00299182|FG006|Participant Flow|10 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10850885|NCT04262947|OG001|Outcome|VeinViewer Visualization Only|"Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement~Conventional IV placement: IV placement utilizing conventional methods"
10964115|NCT00875836|EG001|Reported Event|Placebo|Placebo: Flexible dose up to 60mg/day
10964116|NCT00875979|BG000|Baseline|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11243288|NCT02501928|EG004|Reported Event|Fesoterodine 4 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243289|NCT02501928|EG005|Reported Event|Total of Treatment Groups|Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
10964117|NCT00875979|BG001|Baseline|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
10964118|NCT00875979|BG002|Baseline|Total|Total of all reporting groups
10800442|NCT00433511|EG002|Reported Event|Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy)|Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.
10800443|NCT00433511|EG003|Reported Event|Arm D (Bevacizumab Cycles 9-18 of Arm C)|After completion of 4 cycles of paclitaxel and bevacizumab in arm C, patients then receive bevacizumab IV over 30-90 minutes on day 1 every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.
11377787|NCT01140451|BG001|Baseline|Placebo/Ataluren|Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377788|NCT01140451|BG002|Baseline|Total|Total of all reporting groups
11377789|NCT01140451|FG000|Participant Flow|Ataluren/Ataluren|Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377790|NCT01140451|FG001|Participant Flow|Placebo/Ataluren|Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377791|NCT01140451|OG000|Outcome|Ataluren/Ataluren|Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377792|NCT01140451|OG001|Outcome|Placebo/Ataluren|Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377793|NCT01140451|EG000|Reported Event|Ataluren/Ataluren|Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377794|NCT01140451|EG001|Reported Event|Placebo/Ataluren|Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
11377795|NCT01140451|EG002|Reported Event|Overall Population|Participants who received double-blind ataluren or placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
10964119|NCT00875979|FG000|Participant Flow|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
10966586|NCT00887588|OG000|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
10964120|NCT00875979|FG001|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11192411|NCT02138825|EG000|Reported Event|Riociguat up to 2.5 mg Tid|Reporting group 1 (RG 1): All participants randomized to Riociguat treatment in Main study treatment phase (data until week 26); participants received Riociguat titrated to optimal dose within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Riociguat Arm of Period 1 in Participant Flow section.
11192412|NCT02138825|EG001|Reported Event|Placebo|Reporting group 2 (RG 2): All participants randomized to Placebo treatment in Main study treatment phase (data until week 26); participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Placebo Arm of Period 1 in Participant Flow section.
11202145|NCT02205476|OG003|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
11377796|NCT01174563|BG000|Baseline|Erlotinib|Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
11377797|NCT01174563|FG000|Participant Flow|Erlotinib|Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
11377798|NCT01174563|OG000|Outcome|Erlotinib|Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
11377799|NCT01174563|EG000|Reported Event|Erlotinib|Participants received 150 milligrams (mg) of Erlotinib orally daily, from Day 1 of the treatment period until unacceptable toxicity, disease progression or withdrawal due to any reason.
11377800|NCT01190202|BG000|Baseline|Overall Study Group (Survey 1)|Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377801|NCT01190202|BG001|Baseline|Overall Study Group (Survey 2)|Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377802|NCT01190202|BG002|Baseline|Overall Study Group (Survey 3)|Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377803|NCT01190202|BG003|Baseline|Overall Study Group (Survey 4)|Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377804|NCT01190202|BG004|Baseline|Total|Total of all reporting groups
11377805|NCT01190202|FG000|Participant Flow|Overall Study Group (Survey 1)|Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377806|NCT01190202|FG001|Participant Flow|Overall Study Group (Survey 2)|Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377807|NCT01190202|FG002|Participant Flow|Overall Study Group (Survey 3)|Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377808|NCT01190202|FG003|Participant Flow|Overall Study Group (Survey 4)|Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377809|NCT01190202|OG000|Outcome|Overall Study Group (Survey 1)|Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377810|NCT01190202|OG001|Outcome|Overall Study Group (Survey 2)|Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377811|NCT01190202|OG002|Outcome|Overall Study Group (Survey 3)|Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
10964121|NCT00875979|OG000|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11377812|NCT01190202|OG003|Outcome|Overall Study Group (Survey 4)|Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377813|NCT01190202|OG000|Outcome|Low PD Group (Survey 1)|Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy.
11377814|NCT01190202|OG001|Outcome|Medium PD Group (Survey 1)|Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377815|NCT01190202|OG002|Outcome|High PD Group (Survey 1)|Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377816|NCT01190202|OG003|Outcome|Very High PD Group (Survey 1)|Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377817|NCT01190202|OG004|Outcome|Neg PD Group (Survey 1)|Subjects from Survey 1 not infected with P.falciparum.
11377818|NCT01190202|OG000|Outcome|Low PD Group (Survey 2)|Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy.
11377819|NCT01190202|OG001|Outcome|Medium PD Group (Survey 2)|Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377820|NCT01190202|OG002|Outcome|High PD Group (Survey 2)|Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377821|NCT01190202|OG003|Outcome|Very High PD Group (Survey 2)|Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377822|NCT01190202|OG004|Outcome|Neg PD Group (Survey 2)|Subjects from Survey 2 not infected with P.falciparum.
11377823|NCT01190202|OG000|Outcome|Low PD Group (Survey 3)|Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy.
11377824|NCT01190202|OG001|Outcome|Medium PD Group (Survey 3)|Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377825|NCT01190202|OG002|Outcome|High PD Group (Survey 3)|Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377826|NCT01190202|OG003|Outcome|Very High PD Group (Survey 3)|Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377827|NCT01190202|OG004|Outcome|Neg PD Group (Survey 3)|Subjects from Survey 3 not infected with P.falciparum.
11377828|NCT01190202|OG000|Outcome|Low PD Group (Survey 4)|Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy.
11377829|NCT01190202|OG001|Outcome|Medium PD Group (Survey 4)|Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377830|NCT01190202|OG002|Outcome|High PD Group (Survey 4)|Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377831|NCT01190202|OG003|Outcome|Very High PD Group (Survey 4)|Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy.
11377832|NCT01190202|OG004|Outcome|Neg PD Group (Survey 4)|Subjects from Survey 4 not infected with P.falciparum.
11377833|NCT01190202|OG000|Outcome|Overall Study Group (6M-4Y) (Survey 1)|Subjects from Survey 1, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377834|NCT01190202|OG001|Outcome|Overall Study Group (5-19Y) (Survey 1)|Subjects from Survey 1, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377835|NCT01190202|OG002|Outcome|Overall Study Group (20Y+) (Survey 1)|Subjects from Survey 1, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377836|NCT01190202|OG000|Outcome|Overall Study Group (6M-4Y) (Survey 2)|Subjects from Survey 2, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377837|NCT01190202|OG001|Outcome|Overall Study Group (5-19Y) (Survey 2)|Subjects from Survey 2, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377838|NCT01190202|OG002|Outcome|Overall Study Group (20Y+) (Survey 2)|Subjects from Survey 2, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
10966587|NCT00887588|OG001|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
11243290|NCT02502019|BG000|Baseline|HEMOBLAST|"All subjects will have the investigational device implanted~HEMOBLAST Bellows: HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical."
11192413|NCT02138825|EG002|Reported Event|Riociguat-Riociguat Transition|Reporting group 3 (RG 3): All participants that were initially randomized to Riociguat treatment in Main study treatment phase and later entered Long-term extension (LTE) phase (data starting from week 26 to study termination); participants received a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Riociguat Arm of Period 2 in Participant Flow section.
11202146|NCT02205476|OG000|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11377839|NCT01190202|OG000|Outcome|Overall Study Group (6M-4Y) (Survey 3)|Subjects from Survey 3, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377840|NCT01190202|OG001|Outcome|Overall Study Group (5-19Y) (Survey 3)|Subjects from Survey 3, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377841|NCT01190202|OG002|Outcome|Overall Study Group (20Y+) (Survey 3)|Subjects from Survey 3, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377842|NCT01190202|OG000|Outcome|Overall Study Group (6M-4Y) (Survey 4)|Subjects from Survey 4, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377843|NCT01190202|OG001|Outcome|Overall Study Group (5-19Y) (Survey 4)|Subjects from Survey 4, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377844|NCT01190202|OG002|Outcome|Overall Study Group (20Y+) (Survey 4)|Subjects from Survey 4, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
11377845|NCT01190202|EG000|Reported Event|Overall Study Group (Survey 1)|Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377846|NCT01190202|EG001|Reported Event|Overall Study Group (Survey 2)|Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377847|NCT01190202|EG002|Reported Event|Overall Study Group (Survey 3)|Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11377848|NCT01190202|EG003|Reported Event|Overall Study Group (Survey 4)|Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
11243291|NCT02502019|FG000|Participant Flow|HEMOBLAST|Subjects received the investigational device, HEMOBLAST Bellows.
11243292|NCT02502019|OG000|Outcome|HEMOBLAST|Subjects received the investigational device, HEMOBLAST Bellows.
11243293|NCT02502019|EG000|Reported Event|HEMOBLAST|Subjects received the investigational device, HEMOBLAST Bellows.
11377849|NCT01200862|BG000|Baseline|BGS649 (Part 1)|BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
11377850|NCT01200862|BG001|Baseline|BGS649 (Part 2)|BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
11377851|NCT01200862|BG002|Baseline|Placebo to BGS649 (Part 2)|Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
11377852|NCT01200862|BG003|Baseline|Total|Total of all reporting groups
11377853|NCT01200862|FG000|Participant Flow|BGS649 Part 1|BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
11377854|NCT01200862|FG001|Participant Flow|BGS649 Part 2|BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
11377855|NCT01200862|FG002|Participant Flow|Placebo to BGS649|Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
11377856|NCT01200862|OG000|Outcome|BGS649 (Part 1)|BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
11377857|NCT01200862|OG000|Outcome|BGS649 Part 2|BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
11377858|NCT01200862|OG001|Outcome|Placebo to BGS649|Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
11377859|NCT01200862|OG000|Outcome|BGS649 (Part 2)|BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
11243294|NCT02502097|BG000|Baseline|Gefapixant>Placebo Pre-Amendment 3|Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
11377860|NCT01200862|EG000|Reported Event|BGS649 (Part 1) Open Label|Individualised doses to titrate testosterone levels to within normal range. Doses ranged between 0.003mg and 5mg in total over the 11 week treatment period. For doses below 0.1mg, separate pharmacy instructions were provided to dilute an oral solution of BGS649.
11377861|NCT01200862|EG001|Reported Event|BGS649 (Part 2)|All subjects were given 0.3mg on Day 1 and then 0.1mg on all other dosing visits (weeks 2-11).
11377862|NCT01200862|EG002|Reported Event|Placebo to BGS649 (Part 2)|Matching placebo capsules on Day 1 and all other dosing visits (weeks 2-11).
11377863|NCT01225341|BG000|Baseline|onabotulinumtoxinA/Placebo|"Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline.~onabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377864|NCT01225341|BG001|Baseline|Bacteriostatic Normal Saline/ onabotulnimtoxinA|"Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA.~onabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377865|NCT01225341|BG002|Baseline|Total|Total of all reporting groups
11377866|NCT01225341|FG000|Participant Flow|onabotulinumtoxinA/Placebo|"Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline.~onabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377867|NCT01225341|FG001|Participant Flow|Bacteriostatic Normal Saline/ onabotulnimtoxinA|"Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA.~onabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377868|NCT01225341|OG000|Outcome|OnabotulinumtoxinA|"Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months.~OnabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11192414|NCT02138825|EG003|Reported Event|Placebo-Riociguat Transition|Reporting group 4 (RG 4): All participants that were initially randomized to Placebo treatment in Main study treatment phase and later entered LTE phase (data starting from week 26 to study termination); participants received a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Placebo Arm of Period 2 in Participant Flow section.
11192415|NCT02138838|BG000|Baseline|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
11192416|NCT02138838|BG001|Baseline|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
11192417|NCT02138838|BG002|Baseline|Total|Total of all reporting groups
11192418|NCT02138838|FG000|Participant Flow|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
11192419|NCT02138838|FG001|Participant Flow|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
11192420|NCT02138838|OG000|Outcome|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
11192421|NCT02138838|OG001|Outcome|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
11192422|NCT02138838|EG000|Reported Event|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
11192423|NCT02138838|EG001|Reported Event|Cinacalcet|In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
11192424|NCT02138890|BG000|Baseline|APS Injection|Autologous Protein Solution (APS): Intra-articular Injection
11192425|NCT02138890|BG001|Baseline|Control|Saline: Intra-articular injection
11192426|NCT02138890|BG002|Baseline|Total|Total of all reporting groups
11192427|NCT02138890|FG000|Participant Flow|APS Injection|"Autologous Protein Solution~APS: Intra-articular Injection"
11192428|NCT02138890|FG001|Participant Flow|Control|Saline: Intra-articular injection
11192429|NCT02138890|OG000|Outcome|APS Injection|Autologous Protein Solution: Intra-articular Injection
11192430|NCT02138890|OG001|Outcome|Control|Saline: Intra-articular injection
11192431|NCT02138890|OG000|Outcome|APS Injection|"Autologous Protein Solution~APS: Intra-articular Injection"
11192432|NCT02138890|EG000|Reported Event|APS Injection|Autologous Protein Solution: Intra-articular Injection
11192433|NCT02138890|EG001|Reported Event|Control|Saline: Intra-articular injection
11192434|NCT02138916|BG000|Baseline|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11192435|NCT02138916|BG001|Baseline|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11192436|NCT02138916|BG002|Baseline|Placebo|Every 8 weeks administered subcutaneously
11192437|NCT02138916|BG003|Baseline|Total|Total of all reporting groups
11192438|NCT02138916|FG000|Participant Flow|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11192439|NCT02138916|FG001|Participant Flow|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11192440|NCT02138916|FG002|Participant Flow|Placebo|Every 8 weeks administered subcutaneously
11192441|NCT02138916|OG000|Outcome|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11192442|NCT02138916|OG001|Outcome|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11192443|NCT02138916|OG002|Outcome|Placebo|Every 8 weeks administered subcutaneously
11192444|NCT02138916|EG000|Reported Event|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11192445|NCT02138916|EG001|Reported Event|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11192446|NCT02138916|EG002|Reported Event|Placebo|Every 8 weeks administered subcutaneously
11192447|NCT02139007|BG000|Baseline|Continuation Arm|Alendronate continuation arm
11192448|NCT02139007|BG001|Baseline|Discontinuation Arm|Alendronate discontinuation arm
11192449|NCT02139007|BG002|Baseline|Total|Total of all reporting groups
11192450|NCT02139007|FG000|Participant Flow|Continuation Arm|"Alendronate continuation arm~Participants were randomized to continue their current alendronate prescription at prescribed dose."
11192451|NCT02139007|FG001|Participant Flow|Discontinuation Arm|"Alendronate discontinuation arm~Participants were randomized to stop taking their current alendronate prescription."
11192452|NCT02139007|OG000|Outcome|All Study Sites -- Contracting Procedures|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
11192453|NCT02139007|OG000|Outcome|All Study Sites --IRB Approval|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
11192454|NCT02139007|OG000|Outcome|All Study Sites-Initiation to the First Participant Recruited|study initiation to the first participant recruited
11192455|NCT02139007|OG000|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
11192456|NCT02139007|OG001|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
11192457|NCT02139007|EG000|Reported Event|Continuation Arm|"Alendronate continuation arm~Alendronate"
11192458|NCT02139007|EG001|Reported Event|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
10800457|NCT00314366|BG000|Baseline|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
11243295|NCT02502097|BG001|Baseline|Placebo>Gefapixant Pre-Amendment 3|Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2
10964122|NCT00875979|OG001|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11243296|NCT02502097|BG002|Baseline|Gefapixant>Placebo Post-Amendment 3|Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
11243297|NCT02502097|BG003|Baseline|Placebo>Gefapixant Post-Amendment 3|Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
10800458|NCT00314366|BG001|Baseline|Control|"Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
10800459|NCT00314366|BG002|Baseline|Total|Total of all reporting groups
10800460|NCT00314366|FG000|Participant Flow|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
11243298|NCT02502097|BG004|Baseline|Total|Total of all reporting groups
11243299|NCT02502097|FG000|Participant Flow|Gefapixant>Placebo Pre-Amendment 3|Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
11243300|NCT02502097|FG001|Participant Flow|Placebo>Gefapixant Pre-Amendment 3|Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2
11243301|NCT02502097|FG002|Participant Flow|Gefapixant>Placebo Post-Amendment 3|Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2
11243302|NCT02502097|FG003|Participant Flow|Placebo>Gefapixant Post-Amendment 3|Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
11243303|NCT02502097|OG000|Outcome|Gefapixant|Gefapixant 50 mg BID for 14 days during 1 of 2 periods
10966588|NCT00887588|EG000|Reported Event|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
11243304|NCT02502097|OG001|Outcome|Placebo|Placebo BID for 14 days during 1 of 2 periods
11243305|NCT02502097|EG000|Reported Event|Placebo|Participants received placebo BID for 14 days
10850886|NCT04262947|OG002|Outcome|Constant Imaging With VeinViewer|"Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement"
10850887|NCT04262947|EG000|Reported Event|Conventional Method|"Placement of peripheral venous catheter using conventional methods~Conventional IV placement: IV placement utilizing conventional methods"
11243306|NCT02502097|EG001|Reported Event|Gefapixant 50 mg|Participants received gefapixant 50 mg BID for 10 or 14 days
11243307|NCT02502097|EG002|Reported Event|Gefapixant 150 mg|Participants received gefapixant 150 mg BID for 4 days
10964123|NCT00875979|EG000|Reported Event|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11192459|NCT02139046|BG000|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192460|NCT02139046|BG001|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192461|NCT02139046|BG002|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192462|NCT02139046|BG003|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192463|NCT02139046|BG004|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192464|NCT02139046|BG005|Baseline|Total|Total of all reporting groups
11192465|NCT02139046|FG000|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192466|NCT02139046|FG001|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192467|NCT02139046|FG002|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
10964124|NCT00875979|EG001|Reported Event|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
11192468|NCT02139046|FG003|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192469|NCT02139046|FG004|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192470|NCT02139046|OG000|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192471|NCT02139046|OG001|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192472|NCT02139046|OG002|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192473|NCT02139046|OG003|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192474|NCT02139046|OG004|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192475|NCT02139046|EG000|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192476|NCT02139046|EG001|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192477|NCT02139046|EG002|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192478|NCT02139046|EG003|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192479|NCT02139046|EG004|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
11192480|NCT02139124|BG000|Baseline|Placebo|"Placebo Arm~Placebo: Oral placebo capsule"
11192481|NCT02139124|BG001|Baseline|PRC-063 25 mg|"PRC-063 25 mg~PRC-063 25 mg: Oral 25 mg capsule - active"
11192482|NCT02139124|BG002|Baseline|PRC-063 45 mg|"PRC-063 45 mg~PRC-063 45 mg: Oral 45 mg capsule - active"
11192483|NCT02139124|BG003|Baseline|PRC-063 70 mg|"PRC-063 70 mg~PRC-063 70 mg: Oral 70 mg capsule - active"
11192484|NCT02139124|BG004|Baseline|PRC-063 100 mg|"PRC-063 100 mg~PRC-063 100 mg: Oral 100 mg capsule - active"
11192485|NCT02139124|BG005|Baseline|Total|Total of all reporting groups
11192486|NCT02139124|FG000|Participant Flow|Placebo|"Placebo Arm~Placebo: Oral placebo capsule"
11192487|NCT02139124|FG001|Participant Flow|PRC-063 25 mg|"PRC-063 25 mg~PRC-063 25 mg: Oral 25 mg capsule - active"
11192488|NCT02139124|FG002|Participant Flow|PRC-063 45 mg|"PRC-063 45 mg~PRC-063 45 mg: Oral 45 mg capsule - active"
11192489|NCT02139124|FG003|Participant Flow|PRC-063 70 mg|"PRC-063 70 mg~PRC-063 70 mg: Oral 70 mg capsule - active"
11192490|NCT02139124|FG004|Participant Flow|PRC-063 100 mg|"PRC-063 100 mg~PRC-063 100 mg: Oral 100 mg capsule - active"
11192491|NCT02139124|OG000|Outcome|PRC-063 25 mg|"PRC-063 25 mg~PRC-063 25 mg: Oral 25 mg capsule - active"
11192492|NCT02139124|OG001|Outcome|PRC-063 45 mg|"PRC-063 45 mg~PRC-063 45 mg: Oral 45 mg capsule - active"
11192493|NCT02139124|OG002|Outcome|PRC-063 70 mg|"PRC-063 70 mg~PRC-063 70 mg: Oral 70 mg capsule - active"
11192494|NCT02139124|OG003|Outcome|PRC-063 100 mg|"PRC-063 100 mg~PRC-063 100 mg: Oral 100 mg capsule - active"
11192495|NCT02139124|OG004|Outcome|0 mg/Day|Placebo
11192496|NCT02139124|EG000|Reported Event|Placebo|"Placebo Arm~Placebo: Oral placebo capsule"
11192497|NCT02139124|EG001|Reported Event|PRC-063 25 mg|"PRC-063 25 mg~PRC-063 25 mg: Oral 25 mg capsule - active"
11192498|NCT02139124|EG002|Reported Event|PRC-063 45 mg|"PRC-063 45 mg~PRC-063 45 mg: Oral 45 mg capsule - active"
11192499|NCT02139124|EG003|Reported Event|PRC-063 70 mg|"PRC-063 70 mg~PRC-063 70 mg: Oral 70 mg capsule - active"
11192500|NCT02139124|EG004|Reported Event|PRC-063 100 mg|"PRC-063 100 mg~PRC-063 100 mg: Oral 100 mg capsule - active"
11192501|NCT02139137|BG000|Baseline|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
11192502|NCT02139137|BG001|Baseline|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
11192503|NCT02139137|BG002|Baseline|Total|Total of all reporting groups
11192504|NCT02139137|FG000|Participant Flow|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
11192505|NCT02139137|FG001|Participant Flow|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
11192506|NCT02139137|OG000|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
11192507|NCT02139137|OG001|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
11192508|NCT02139137|EG000|Reported Event|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
11192509|NCT02139137|EG001|Reported Event|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
11192510|NCT02139176|BG000|Baseline|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
11192511|NCT02139176|BG001|Baseline|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.~patient referral: A patient agrees to recruit their partner using the invitation."
11192512|NCT02139176|BG002|Baseline|Total|Total of all reporting groups
10964125|NCT00876018|BG000|Baseline|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964126|NCT00876018|BG001|Baseline|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964127|NCT00876018|BG002|Baseline|Control Group B (No Intervention)|Participants were not administered with any intervention.
10964128|NCT00876018|BG003|Baseline|Total|Total of all reporting groups
11192513|NCT02139176|FG000|Participant Flow|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
10964129|NCT00876018|FG000|Participant Flow|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
11377869|NCT01225341|OG001|Outcome|Bacteriostatic Normal Saline|"Patients will be injected every 3 months with saline for a period of 12 months.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377870|NCT01225341|EG000|Reported Event|onabotulinumtoxinA|"Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months.~onabotulinumtoxinA: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
11377871|NCT01225341|EG001|Reported Event|Bacteriostatic Normal Saline|"Patients will be injected every 3 months with saline for a period of 12 months.~Bacteriostatic normal saline: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle."
10964130|NCT00876018|FG001|Participant Flow|Control Group A (Un-fortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
11377872|NCT01235962|BG000|Baseline|ITT Pazopanib 800 mg|Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377873|NCT01235962|BG001|Baseline|ITT Placebo 800 mg|Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.
11377874|NCT01235962|BG002|Baseline|ITT Pazopanib 600 mg|Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.
11377875|NCT01235962|BG003|Baseline|ITT Placebo 600 mg|Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
11377876|NCT01235962|BG004|Baseline|Total|Total of all reporting groups
11377877|NCT01235962|FG000|Participant Flow|ITT Pazopanib 800 mg|Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377878|NCT01235962|FG001|Participant Flow|ITT Placebo 800 mg|Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.
11377879|NCT01235962|FG002|Participant Flow|ITT Pazopanib 600 mg|Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.
11377880|NCT01235962|FG003|Participant Flow|ITT Placebo 600 mg|Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
11377881|NCT01235962|OG000|Outcome|ITT Pazopanib 600 mg|Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.
11377882|NCT01235962|OG001|Outcome|ITT Placebo 600 mg|Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
11377883|NCT01235962|OG000|Outcome|ITT All - Pazopanib|All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
11377884|NCT01235962|OG001|Outcome|ITT All - Placebo|All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
11377885|NCT01235962|OG000|Outcome|ITT Pazopanib 800 mg|Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377886|NCT01235962|OG001|Outcome|ITT Placebo 800 mg|Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.
11377887|NCT01235962|OG000|Outcome|Safety Pazopanib 800 mg|Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377888|NCT01235962|OG001|Outcome|Safety Placebo 800 mg|Placebo matching pazopanib 800 mg daily based on safety evaluation. Complete treatment is 12 months.
11377889|NCT01235962|OG002|Outcome|Safety Pazopanib 600 mg|Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377890|NCT01235962|OG003|Outcome|Safety Placebo 600 mg|Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
11377891|NCT01235962|EG000|Reported Event|ITT Pazopanib 800 mg|Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
11377892|NCT01235962|EG001|Reported Event|ITT Placebo 800 mg|Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.
11377893|NCT01235962|EG002|Reported Event|I TT Pazopanib 600 mg|Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.
11377894|NCT01235962|EG003|Reported Event|ITT Placebo 600 mg|Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
11377895|NCT01235962|EG004|Reported Event|ITT All - Pazopanib|All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
11377896|NCT01235962|EG005|Reported Event|ITT All - Placebo|All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
11377897|NCT01239368|BG000|Baseline|Cohort 1 - 1x10(5) T Cells/kg|1x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377898|NCT01239368|BG001|Baseline|Cohort 2 - 5x10(5) T Cells/kg|5x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377899|NCT01239368|BG002|Baseline|Cohort 3 - 1x10(6) T Cells/kg|1x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377900|NCT01239368|BG003|Baseline|Cohort 4 - 3x10(6) T Cells/kg|3x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377901|NCT01239368|BG004|Baseline|Cohort 5 - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377902|NCT01239368|BG005|Baseline|Cohort 5B - 5x10(6) T Rapa Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377903|NCT01239368|BG006|Baseline|Cohort 6 - 15x10(6) T Cells/kg|15x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377904|NCT01239368|BG007|Baseline|Cohort 7 - 45x10(6) T Cells/kg|45x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377905|NCT01239368|BG008|Baseline|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg"
11377906|NCT01239368|BG009|Baseline|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/TC1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377907|NCT01239368|BG010|Baseline|Total|Total of all reporting groups
11377908|NCT01239368|FG000|Participant Flow|Cohort 1 - 1x10(5) T Cells/kg|1x10(5) Th1/Tc1 Rapa cells/kg of body weight
11377909|NCT01239368|FG001|Participant Flow|Cohort 2 - 5x10(5) T Cells/kg|5x10(5) Th1/Tc1 Rapa cells/kg of body weight
11377910|NCT01239368|FG002|Participant Flow|Cohort 3 - 1x10(6) T Cells/kg|1x10(6) Th1/Tc1 Rapa cells/kg of body weight
11377911|NCT01239368|FG003|Participant Flow|Cohort 4 - 3x10(6) T Cells/kg|3x10(6) Th1/Tc1 Rapa cells/kg of body weight
11377912|NCT01239368|FG004|Participant Flow|Cohort 5 - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1 Rapa cells/kg of body weight
11377913|NCT01239368|FG005|Participant Flow|Cohort 5B - 5x10(6) T Rapa Cells/kg|5x10(6) Th1/Tc1 Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377914|NCT01239368|FG006|Participant Flow|Cohort 6 - 15x10(6) T Cells/kg|15x10(6) Th1/Tc1 Rapa cells/kg of body weight
11377915|NCT01239368|FG007|Participant Flow|Cohort 7 - 45x10(6) T Cells/kg of|45x10(6) Th1/Tc1 Rapa cells/kg of body weight
11240888|NCT02482675|FG006|Participant Flow|Milk, Then Whey Protein, Then Glucose, Then Sodium Caseinate|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240889|NCT02482675|FG007|Participant Flow|Milk, Then Whey Protein, Then Sodium Caseinate, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240890|NCT02482675|FG008|Participant Flow|Milk, Then Sodium Caseinate, Then Whey Protein, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240891|NCT02482675|FG009|Participant Flow|Milk, Then Glucose, Then Whey Protein, Then Sodium Caseinate|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240892|NCT02482675|FG010|Participant Flow|Milk, Then Sodium Caseinate, Then Glucose, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240893|NCT02482675|FG011|Participant Flow|Whey Protein, Then Glucose, Then Sodium Caseinate, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240894|NCT02482675|FG012|Participant Flow|Whey Protein, Then Glucose, Then Milk, Then Sodium Caseinate|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240895|NCT02482675|FG013|Participant Flow|Whey Protein, Then Sodium Caseinate, Then Glucose, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
10964131|NCT00876018|FG002|Participant Flow|Control Group B (No Intervention)|Participants were not administered with any intervention.
11377916|NCT01239368|FG008|Participant Flow|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1Rapa: 5 x 10e(6) cells/kg"
11377917|NCT01239368|FG009|Participant Flow|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1rapa: 5 x 10e(6) cells/kg"
11377918|NCT01239368|OG000|Outcome|Cohort 1 - 1x10(5) T Cells/kg|1x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377919|NCT01239368|OG001|Outcome|Cohort 2 - 5x10(5) T Cells/kg|5x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377920|NCT01239368|OG002|Outcome|Cohort 3 - 1x10(6) T Cells/kg|1x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377921|NCT01239368|OG003|Outcome|Cohort 4 - 3x10(6) T Cells/kg|3x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377922|NCT01239368|OG004|Outcome|Cohort 5 - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377923|NCT01239368|OG005|Outcome|Cohort 5B - - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377924|NCT01239368|OG006|Outcome|Cohort 6 - 15x10(6) T Cells/kg|15x10(6) Th1/Tc1.Rapac ells/kg of body weight
11377925|NCT01239368|OG007|Outcome|Cohort 7- 45x10(6) T Cells/kg|45x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377926|NCT01239368|OG008|Outcome|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa 5 x 10e(6) cells/kg"
11377927|NCT01239368|OG009|Outcome|Cohort B - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377928|NCT01239368|OG000|Outcome|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1 (type 1 T helper cells)/Tc1 (T cytotoxic cells, type 1) Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1.Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377929|NCT01239368|OG000|Outcome|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1 (type 1 T helper cells)/Tc1 (T cytotoxic cells, type 1) Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377930|NCT01239368|OG005|Outcome|Cohort 5B - 5x10(6) Th1 Rapa Cells/kg|5x10(6) Th1 rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377931|NCT01239368|OG006|Outcome|Cohort 6 - 15x10(6) T Cells/kg|15x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377932|NCT01239368|OG007|Outcome|Cohort 7 - 45x10(6) T Cells/kg|45x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377933|NCT01239368|OG008|Outcome|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377934|NCT01239368|OG009|Outcome|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg"
11377935|NCT01239368|OG005|Outcome|Cohort 5B - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377936|NCT01239368|OG007|Outcome|Cohort 7 - 45x10(6) T Cells/kg|45x10(6) th1 cells/kg of body weight
11377937|NCT01239368|OG008|Outcome|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg"
11377938|NCT01239368|OG009|Outcome|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg"
11377939|NCT01239368|EG000|Reported Event|Cohort 1 - 1x10(5) T Cells/kg|1x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377940|NCT01239368|EG001|Reported Event|Cohort 2 - 5x10(5) T Cells/kg|5x10(5) Th1/Tc1.Rapa cells/kg of body weight
11377941|NCT01239368|EG002|Reported Event|Cohort 3 - 1x10(6) T Cells/kg|1x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377942|NCT01239368|EG003|Reported Event|Cohort 4 - 3x10(6) T Cells/kg|3x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377943|NCT01239368|EG004|Reported Event|Cohort 5 - 5x10(6) T Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377944|NCT01239368|EG005|Reported Event|Cohort 5B - 5x10(6) T Rapa Cells/kg|5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
11377945|NCT01239368|EG006|Reported Event|Cohort 6 - 15x10(6) T Cells/kg|15x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377946|NCT01239368|EG007|Reported Event|Cohort 7 - 45x10(6) T Cells/kg|45x10(6) Th1/Tc1.Rapa cells/kg of body weight
11377947|NCT01239368|EG008|Reported Event|Cohort A - Th1/Tc1.Rapa Prevention of Relapse|"Th1/Tc1.Rapa Prevention of Relapse~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.~Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg"
11377948|NCT01239368|EG009|Reported Event|Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma|"Th1/Tc1.Rapa for Relapsed Multiple Myeloma~Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).~Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg"
10964132|NCT00876018|OG000|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964133|NCT00876018|OG001|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
11377953|NCT01266031|BG000|Baseline|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
10800461|NCT00314366|FG001|Participant Flow|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
11202147|NCT02205476|OG002|Outcome|Group 2: PF-06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
10964134|NCT00876018|OG002|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
10966589|NCT00887588|EG001|Reported Event|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
10964135|NCT00876018|OG000|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10800462|NCT00314366|OG000|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
10800463|NCT00314366|OG001|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
11192514|NCT02139176|FG001|Participant Flow|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.~patient referral: A patient agrees to recruit their partner using the invitation."
10964136|NCT00876018|OG001|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964137|NCT00876018|EG000|Reported Event|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964138|NCT00876018|EG001|Reported Event|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
10964139|NCT00876018|EG002|Reported Event|Control Group B (No Intervention)|Participants were not administered with any intervention.
10964140|NCT00876187|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964141|NCT00876187|BG001|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964142|NCT00876187|BG002|Baseline|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964143|NCT00876187|BG003|Baseline|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964144|NCT00876187|BG004|Baseline|Naproxen 500 mg|Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
10964145|NCT00876187|BG005|Baseline|Total|Total of all reporting groups
10964146|NCT00876187|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964147|NCT00876187|FG001|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964148|NCT00876187|FG002|Participant Flow|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964149|NCT00876187|FG003|Participant Flow|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964150|NCT00876187|FG004|Participant Flow|Naproxen 500 mg|Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
10964151|NCT00876187|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964152|NCT00876187|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11377954|NCT01266031|BG001|Baseline|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
10964153|NCT00876187|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11192515|NCT02139176|OG000|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
10964154|NCT00876187|OG003|Outcome|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11192516|NCT02139176|OG001|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
11192517|NCT02139176|OG001|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~Contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
11192518|NCT02139176|EG000|Reported Event|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information~patient referral: A patient agrees to recruit their partner using the invitation."
11192519|NCT02139176|EG001|Reported Event|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.~contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
11192520|NCT02139228|BG000|Baseline|Hib CRM197|"Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11192521|NCT02139228|BG001|Baseline|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11192522|NCT02139228|BG002|Baseline|Total|Total of all reporting groups
11192523|NCT02139228|FG000|Participant Flow|Hib CRM197|"Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11192524|NCT02139228|FG001|Participant Flow|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11192525|NCT02139228|OG000|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
10800464|NCT00314366|OG000|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
10800465|NCT00314366|OG001|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
10800466|NCT00314366|OG001|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
10964155|NCT00876187|OG004|Outcome|Naproxen 500 mg|Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
10800467|NCT00314366|EG000|Reported Event|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
10964156|NCT00876187|OG000|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964157|NCT00876187|OG001|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11192526|NCT02139228|OG001|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11377955|NCT01266031|BG002|Baseline|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
10800468|NCT00314366|EG001|Reported Event|Control|"Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
10800469|NCT00187226|BG000|Baseline|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
10800470|NCT00187226|BG001|Baseline|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
10800471|NCT00187226|BG002|Baseline|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
10800472|NCT00187226|BG003|Baseline|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
11377956|NCT01266031|BG003|Baseline|Total|Total of all reporting groups
11377957|NCT01266031|FG000|Participant Flow|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
11192527|NCT02139228|EG000|Reported Event|Hib CRM197|"Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
10800473|NCT00187226|BG004|Baseline|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
10800474|NCT00187226|BG005|Baseline|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
10800475|NCT00187226|BG006|Baseline|Total|Total of all reporting groups
10800476|NCT00187226|FG000|Participant Flow|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
10800477|NCT00187226|FG001|Participant Flow|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
10964158|NCT00876187|OG002|Outcome|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964159|NCT00876187|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11377958|NCT01266031|FG001|Participant Flow|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
11377959|NCT01266031|FG002|Participant Flow|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
10800478|NCT00187226|FG002|Participant Flow|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
11377960|NCT01266031|OG000|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
10800479|NCT00187226|FG003|Participant Flow|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
10800480|NCT00187226|FG004|Participant Flow|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
11192528|NCT02139228|EG001|Reported Event|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
11377961|NCT01266031|OG001|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
10800481|NCT00187226|FG005|Participant Flow|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
10800482|NCT00187226|OG000|Outcome|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
11377962|NCT01266031|OG000|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
11377963|NCT01266031|OG000|Outcome|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
11377964|NCT01266031|OG001|Outcome|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
11202148|NCT02205476|OG000|Outcome|Group 1: PF--06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
11377965|NCT01266031|OG000|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
11377966|NCT01266031|OG000|Outcome|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
11377949|NCT01247701|BG000|Baseline|Umbilical Cord Blood Transplant|"Busulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion~Busulfan: Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.~Fludarabine: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2.~Cord Blood Stem Cell Infusion: The cord blood stem cells will be infused on Day 0."
11377950|NCT01247701|FG000|Participant Flow|Umbilical Cord Blood Transplant|"Busulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion~Busulfan: Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.~Fludarabine: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2.~Cord Blood Stem Cell Infusion: The cord blood stem cells will be infused on Day 0."
11377951|NCT01247701|OG000|Outcome|Umbilical Cord Blood Transplant|"Busulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion~Busulfan: Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.~Fludarabine: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2.~Cord Blood Stem Cell Infusion: The cord blood stem cells will be infused on Day 0."
11377952|NCT01247701|EG000|Reported Event|Umbilical Cord Blood Transplant|"Busulfan,Cyclophosphamide, Fludarabine, Cord Blood Stem Cell Infusion~Busulfan: Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.~Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.~Fludarabine: Fludarabine will be given IV daily over 1 hour for 3 days. Dosing will be as follows: for patients ≤ 10 kg: 1.3 mg/kg; for patients > 10 kg: 40 mg/m^2.~Cord Blood Stem Cell Infusion: The cord blood stem cells will be infused on Day 0."
11377967|NCT01266031|OG001|Outcome|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
11377968|NCT01266031|OG002|Outcome|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
11377969|NCT01266031|OG000|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
11377970|NCT01266031|OG001|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
11377971|NCT01266031|OG002|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
10800483|NCT00187226|OG001|Outcome|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
11377972|NCT01266031|OG000|Outcome|All Participants|All participants who received at least one dose of Bevacizumab by vein and/or Bevacizumab (by vein) + Vorinostat by mouth of a 28 day cycle.
11377973|NCT01266031|OG001|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
11377974|NCT01266031|EG000|Reported Event|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
11377975|NCT01266031|EG001|Reported Event|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
11377976|NCT01266031|EG002|Reported Event|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
10964160|NCT00876187|EG001|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964161|NCT00876187|EG002|Reported Event|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
10964162|NCT00876187|EG003|Reported Event|Tanezumab 20 mg|Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16.
11192529|NCT02139280|BG000|Baseline|Arm 1: 1.5 Gms/m(2) Cyclophosphamide|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192530|NCT02139280|BG001|Baseline|Arm 2: Cyclophosphamide 3 Gms/m(2)|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192531|NCT02139280|BG002|Baseline|Total|Total of all reporting groups
11192532|NCT02139280|FG000|Participant Flow|Arm 1: 1.5 Gms/m(2) Cyclophosphamide|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11202149|NCT02205476|OG001|Outcome|Group 2: PF--06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
11377977|NCT01287741|BG000|Baseline|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377978|NCT01287741|BG001|Baseline|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377979|NCT01287741|BG002|Baseline|Total|Total of all reporting groups
11377980|NCT01287741|FG000|Participant Flow|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377981|NCT01287741|FG001|Participant Flow|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377982|NCT01287741|OG000|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377983|NCT01287741|OG001|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377984|NCT01287741|OG000|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377985|NCT01287741|EG000|Reported Event|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377986|NCT01287741|EG001|Reported Event|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
11377987|NCT01304316|BG000|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11377988|NCT01304316|FG000|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11377989|NCT01304316|OG000|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
11377990|NCT01304316|EG000|Reported Event|Standard K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl
11377991|NCT01304316|EG001|Reported Event|High K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
11377992|NCT01313689|BG000|Baseline|Any Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11192533|NCT02139280|FG001|Participant Flow|Arm 2: Cyclophosphamide 3 Gms/m(2)|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192534|NCT02139280|OG000|Outcome|Arm 1: 1.5 Gms/m(2) Cyclophosphamide|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192535|NCT02139280|OG001|Outcome|Arm 2: Cyclophosphamide 3 Gms/m(2)|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192536|NCT02139280|EG000|Reported Event|Arm 1: 1.5 Gms/m(2) Cyclophosphamide|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192537|NCT02139280|EG001|Reported Event|Arm 2: Cyclophosphamide 3 Gms/m(2)|"Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).~Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects."
11192538|NCT02139306|BG000|Baseline|Ataluren|Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation
11192539|NCT02139306|BG001|Baseline|Placebo|Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation.
11192540|NCT02139306|BG002|Baseline|Total|Total of all reporting groups
11192541|NCT02139306|FG000|Participant Flow|Ataluren|Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation.
11192542|NCT02139306|FG001|Participant Flow|Placebo|Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation.
11192543|NCT02139306|OG000|Outcome|Ataluren|Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation
11192544|NCT02139306|OG001|Outcome|Placebo|Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation.
11192545|NCT02139306|OG000|Outcome|Ataluren|Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation.
11192546|NCT02139306|EG000|Reported Event|Ataluren|Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation.
10800484|NCT00187226|OG002|Outcome|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
11192547|NCT02139306|EG001|Reported Event|Placebo|Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation.
11192548|NCT02139358|BG000|Baseline|Dose Escalation / Phase II Treatment|Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
11192549|NCT02139358|FG000|Participant Flow|Dose Escalation / Phase II Treatment|"Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.~Gemcitabine: The Phase I trial will start at the recommended phase II dose (RP2D) for gemcitabine but will have a de-escalation dose levels in the event that an unacceptable toxicity requires dose reduction. Dose level 0 = gemcitabine (1200mg/m2) IV D1,8 q21 days; Dose level -1 = gemcitabine (1000 mg/m^2) IV D1,8 q21 days; Dose level -2 = gemcitabine (850 mg/m^2) IV D1,8 q21 days. The RP2D will be the dose level where 0-1 dose limiting toxicities (DLTs) in six patients occur.~Trastuzumab: Trastuzumab will be given using an 8 mg/kg loading dose on cycle one, day one (C1D1), followed by 6 mg/kg IV on subsequent cycles every (q) 21 days.~Pertuzumab: Pertuzumab will be given using an 840 mg IV loading dose on C1D1, followed by 420 mg IV on subsequent cycles q21 days."
11192550|NCT02139358|OG000|Outcome|Dose Escalation / Phase II Treatment|Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
11192551|NCT02139358|EG000|Reported Event|Dose Escalation / Phase II Treatment|Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
11192552|NCT02139592|BG000|Baseline|Brentuximab Vedotin Infusion|Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
10964163|NCT00876187|EG004|Reported Event|Naproxen 500 mg|Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8.
10964164|NCT00876200|BG000|Baseline|Minoxidil|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.~Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
11192553|NCT02139592|FG000|Participant Flow|Brentuximab Vedotin Infusion|Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
11192554|NCT02139592|OG000|Outcome|Brentuximab Vedotin Infusion|Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
11192555|NCT02139592|EG000|Reported Event|Brentuximab Vedotin Infusion|Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
10800485|NCT00187226|OG003|Outcome|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
10800486|NCT00187226|OG004|Outcome|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
10800487|NCT00187226|OG005|Outcome|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
10800488|NCT00187226|EG000|Reported Event|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
10800489|NCT00187226|EG001|Reported Event|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
10800490|NCT00187226|EG002|Reported Event|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
10800491|NCT00187226|EG003|Reported Event|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
10800492|NCT00187226|EG004|Reported Event|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
10800493|NCT00187226|EG005|Reported Event|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
10800494|NCT00119847|BG000|Baseline|PCI+Optimal Medical Therapy|"PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy~PCI~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800495|NCT00119847|BG001|Baseline|Optimal Medical Therapy|"Optimal medical therapy alone~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800496|NCT00119847|BG002|Baseline|Total|Total of all reporting groups
10800497|NCT00119847|FG000|Participant Flow|PCI+Optimal Medical Therapy|"PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800498|NCT00119847|FG001|Participant Flow|Optimal Medical Therapy|"Optimal medical therapy alone~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800499|NCT00119847|OG000|Outcome|PCI+Optimal Medical Therapy|"PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy~PCI~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800500|NCT00119847|OG001|Outcome|Optimal Medical Therapy|"Optimal medical therapy alone~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800501|NCT00119847|EG000|Reported Event|PCI+Optimal Medical Therapy|"PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10800502|NCT00119847|EG001|Reported Event|Optimal Medical Therapy|"Optimal medical therapy alone~Optimal Medical Therapy: Guideline-directed drug therapies after MI"
10803642|NCT02878603|BG000|Baseline|Standard of Care (SoC) (Treated in Study C301)|Participants who completed study ALX0681-C301 with SoC (plasma exchange [PE], corticosteroid and other immunosuppressive agents) treatment were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product [IMP], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg intravenous (IV) dose followed by a daily 10 milligrams (mg) subcutaneous (SC) injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10803643|NCT02878603|BG001|Baseline|Caplacizumab (Treated in Study C301)|Participants who completed study ALX0681-C301 and received caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to IMP, withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg IV dose followed by a daily 10 mg SC injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10803644|NCT02878603|BG002|Baseline|Total Title|
10803645|NCT02878603|FG000|Participant Flow|Standard of Care (SoC) (Treated in Study C301)|Participants who completed study ALX0681-C301 with SoC (plasma exchange [PE], corticosteroid and other immunosuppressive agents) treatment were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product [IMP], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg intravenous (IV) dose followed by a daily 10 milligrams (mg) subcutaneous (SC) injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10850528|NCT00303316|BG000|Baseline|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10800503|NCT04748783|BG000|Baseline|Sterile Water|Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
11340456|NCT03654560|FG000|Participant Flow|HemoStyp|"Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.~HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use."
10800504|NCT04748783|BG001|Baseline|Peroxyl|Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
10800505|NCT04748783|BG002|Baseline|Periogard|Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
10800506|NCT04748783|BG003|Baseline|Peroxyl & Periogard|Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds.
10800507|NCT04748783|BG004|Baseline|Colgate Total Zero|Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds
11192556|NCT02139644|BG000|Baseline|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192557|NCT02139644|BG001|Baseline|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192558|NCT02139644|BG002|Baseline|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192559|NCT02139644|BG003|Baseline|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192560|NCT02139644|BG004|Baseline|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192561|NCT02139644|BG005|Baseline|Total|Total of all reporting groups
11192562|NCT02139644|FG000|Participant Flow|Enrolled Patients|During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
10800508|NCT04748783|BG005|Baseline|Total|Total of all reporting groups
10800509|NCT04748783|FG000|Participant Flow|Sterile Water|Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
10800510|NCT04748783|FG001|Participant Flow|Peroxyl|Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
10800511|NCT04748783|FG002|Participant Flow|Periogard|Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse
10964165|NCT00876200|BG001|Baseline|Placebo|"Placebo = lactose~Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10800512|NCT04748783|FG003|Participant Flow|Peroxyl & Periogard|Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds
10964166|NCT00876200|BG002|Baseline|Total|Total of all reporting groups
10800513|NCT04748783|FG004|Participant Flow|Colgate Total Zero|Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds
11192563|NCT02139644|FG001|Participant Flow|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192564|NCT02139644|FG002|Participant Flow|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192565|NCT02139644|FG003|Participant Flow|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192566|NCT02139644|FG004|Participant Flow|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192567|NCT02139644|FG005|Participant Flow|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800514|NCT04748783|OG000|Outcome|Sterile Water|Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
10800515|NCT04748783|OG001|Outcome|Peroxyl|Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
10800516|NCT04748783|OG002|Outcome|Periogard|Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
10800517|NCT04748783|OG003|Outcome|Peroxyl & Periogard|Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds.
10800518|NCT04748783|OG004|Outcome|Colgate Total Zero|Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds
10800519|NCT04748783|OG003|Outcome|Peroxyl & Periogard|Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds
10800520|NCT04748783|EG000|Reported Event|Sterile Water|Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
10800521|NCT04748783|EG001|Reported Event|Peroxyl|Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
10800522|NCT04748783|EG002|Reported Event|Periogard|Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
11377993|NCT01313689|BG001|Baseline|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) & well-established standards of care as prescribed with standard dose & route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status & anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt & demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
11377994|NCT01313689|BG002|Baseline|Ofatumumab Extended (OFA Ext)|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11377995|NCT01313689|BG003|Baseline|Ofatumumab Observation (OFA Observ.)|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11377996|NCT01313689|BG004|Baseline|OFA First Randomization Only (OFA FRO)|"Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.~Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU."
11377997|NCT01313689|BG005|Baseline|Total|Total of all reporting groups
11377998|NCT01313689|FG000|Participant Flow|Any Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11377999|NCT01313689|FG001|Participant Flow|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) & well-established standards of care as prescribed with standard dose & route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status & anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt & demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
11378000|NCT01313689|FG002|Participant Flow|Ofatumumab Extended (OFA Ext)|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378001|NCT01313689|FG003|Participant Flow|Ofatumumab Observation (OFA Observ.)|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11192568|NCT02139644|OG000|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192569|NCT02139644|OG001|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192570|NCT02139644|OG002|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10966590|NCT00887640|BG000|Baseline|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
11192571|NCT02139644|OG003|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192572|NCT02139644|OG004|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192573|NCT02139644|EG000|Reported Event|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192574|NCT02139644|EG001|Reported Event|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11378002|NCT01313689|FG004|Participant Flow|OFA First Randomization Only (OFA FRO)|"Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.~Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU."
11378003|NCT01313689|OG000|Outcome|Any Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378004|NCT01313689|OG001|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) & well-established standards of care as prescribed with standard dose & route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status & anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt & demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
11378005|NCT01313689|OG002|Outcome|Ofatumumab Extended (OFA Ext)|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378006|NCT01313689|OG003|Outcome|Ofatumumab Observation (OFA Observ.)|These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11192575|NCT02139644|EG002|Reported Event|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10966591|NCT00887640|FG000|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
11192576|NCT02139644|EG003|Reported Event|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800523|NCT04748783|EG003|Reported Event|Peroxyl & Periogard|Subject participants will complete an on-label sequential rinse starting with Peroxyl (1.5% w/v hydrogen peroxide) 10 mL for 60 seconds and then Periogard (0.12% Chlorhexidine Gluconate) 15 mL for 30 seconds.
10800524|NCT04748783|EG004|Reported Event|Colgate Total Zero|Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20 mL for 30 seconds
10800525|NCT04482647|BG000|Baseline|Supportive Care (Video, Breathing Techniques, Meditation)|Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
10800526|NCT04482647|FG000|Participant Flow|Supportive Care (Video, Breathing Techniques, Meditation)|Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
10800527|NCT04482647|OG000|Outcome|Supportive Care (Video, Breathing Techniques, Meditation)|Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
10800528|NCT04482647|EG000|Reported Event|Supportive Care (Video, Breathing Techniques, Meditation)|Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
10800529|NCT04405570|BG000|Baseline|Molnupiravir 200 mg|molnupiravir twice daily (BID) for 5 days
10800530|NCT04405570|BG001|Baseline|Molnupiravir 400 mg|molnupiravir twice daily (BID) for 5 days
10800531|NCT04405570|BG002|Baseline|Molnupiravir 800 mg|molnupiravir twice daily (BID) for 5 days
10800532|NCT04405570|BG003|Baseline|Placebo|Placebo twice daily (BID) for 5 days
10800533|NCT04405570|BG004|Baseline|Total|Total of all reporting groups
10800534|NCT04405570|FG000|Participant Flow|Molnupiravir 200 mg|molnupiravir twice daily (BID) for 5 days
10800535|NCT04405570|FG001|Participant Flow|Molnupiravir 400 mg|molnupiravir twice daily (BID) for 5 days
10800536|NCT04405570|FG002|Participant Flow|Molnupiravir 800 mg|molnupiravir twice daily (BID) for 5 days
10800537|NCT04405570|FG003|Participant Flow|Placebo|Placebo twice daily (BID) for 5 days
10800538|NCT04405570|OG000|Outcome|Molnupiravir 200 mg|molnupiravir twice daily (BID) for 5 days
10800539|NCT04405570|OG001|Outcome|Molnupiravir 400 mg|molnupiravir twice daily (BID) for 5 days
10800540|NCT04405570|OG002|Outcome|Molnupiravir 800 mg|molnupiravir twice daily (BID) for 5 days
10800541|NCT04405570|OG003|Outcome|Placebo|Placebo twice daily (BID) for 5 days
10800542|NCT04405570|OG000|Outcome|Molnupiravir 200 mg|EIDD-2801 twice daily (BID) for 5 days
10800543|NCT04405570|OG001|Outcome|Molnupiravir 400 mg|EIDD-2801 twice daily (BID) for 5 days
10800544|NCT04405570|OG002|Outcome|Molnupiravir 800 mg|EIDD-2801 twice daily (BID) for 5 days
10800545|NCT04405570|EG000|Reported Event|Molnupiravir 200 mg|EIDD-2801 twice daily (BID) for 5 days
10800546|NCT04405570|EG001|Reported Event|Molnupiravir 400 mg|EIDD-2801 twice daily (BID) for 5 days
10800547|NCT04405570|EG002|Reported Event|Molnupiravir 800 mg|EIDD-2801 twice daily (BID) for 5 days
10800548|NCT04405570|EG003|Reported Event|Placebo|Placebo twice daily (BID) for 5 days
10850529|NCT00303316|BG001|Baseline|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10850530|NCT00303316|BG002|Baseline|Total|Total of all reporting groups
10850531|NCT00303316|FG000|Participant Flow|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10850532|NCT00303316|FG001|Participant Flow|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10850533|NCT00303316|OG000|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10964167|NCT00876200|FG000|Participant Flow|Minoxidil|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.~Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964168|NCT00876200|FG001|Participant Flow|Placebo|"Placebo = lactose~Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964169|NCT00876200|OG000|Outcome|Minoxidil|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.~Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964170|NCT00876200|OG001|Outcome|Placebo|"Placebo = lactose~Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964171|NCT00876200|EG000|Reported Event|Minoxidil|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.~Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964172|NCT00876200|EG001|Reported Event|Placebo|"Placebo = lactose~Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
10964173|NCT00876265|BG000|Baseline|Overall Study|
10964174|NCT00876265|FG000|Participant Flow|Overall Study|
10964175|NCT00876265|OG000|Outcome|Belotero|Belotero was injected into the left or right nasolabial fold using a randomization schedule.
10964176|NCT00876265|OG001|Outcome|Zyplast|Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
10964177|NCT00876265|EG000|Reported Event|Belotero|
10964178|NCT00876265|EG001|Reported Event|Zyplast|
10964179|NCT00876343|BG000|Baseline|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
10964180|NCT00876343|BG001|Baseline|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
10964181|NCT00876343|BG002|Baseline|Placebo Group|Placebo were administered orally once daily
10964182|NCT00876343|BG003|Baseline|Total|Total of all reporting groups
10964183|NCT00876343|FG000|Participant Flow|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
10964184|NCT00876343|FG001|Participant Flow|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
10964185|NCT00876343|FG002|Participant Flow|Placebo Group|Placebo were administered orally once daily
10964186|NCT00876343|OG000|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
10964187|NCT00876343|OG001|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
10964188|NCT00876343|OG002|Outcome|Placebo Group|Placebo were administered orally once daily
11192577|NCT02139644|EG004|Reported Event|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192578|NCT02139800|BG000|Baseline|Control Arm-Standard of Care|"Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention~Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention"
11192579|NCT02139800|BG001|Baseline|Sustained Intervention|"Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O~Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds"
11192580|NCT02139800|BG002|Baseline|Total|Total of all reporting groups
11192581|NCT02139800|FG000|Participant Flow|Control Arm-Standard of Care|"Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention~Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention"
10964189|NCT00876343|EG000|Reported Event|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
10964190|NCT00876343|EG001|Reported Event|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
11192582|NCT02139800|FG001|Participant Flow|Sustained Intervention|"Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O~Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds"
11192583|NCT02139800|OG000|Outcome|Control Arm-Standard of Care|"Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention~Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention"
11192584|NCT02139800|OG001|Outcome|Sustained Intervention|"Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O~Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds"
10964191|NCT00876343|EG002|Reported Event|Placebo Group|Placebo were administered orally once daily
10964192|NCT00876395|BG000|Baseline|Everolimus + Paclitaxel + Trastuzumab|Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
11192585|NCT02139800|EG000|Reported Event|Control Arm-Standard of Care|"Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention~Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention"
11192586|NCT02139800|EG001|Reported Event|Sustained Intervention|"Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O~Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds"
11192587|NCT02139826|BG000|Baseline|Overall Study|All 12 randomized participants
11192588|NCT02139826|FG000|Participant Flow|Overall Study|"Single oral dose of 800 milligrams IX-01 as an aqueous dispersion while fasting, or as a capsule while fasting, or as capsule while fed, in each of 3 treatment periods~IX-01"
11192589|NCT02139826|OG000|Outcome|IX-01 Capsule While Fasting|"Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods~IX-01"
11192590|NCT02139826|OG000|Outcome|IX-01 Capsule After Food|"Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods~IX-01"
11192591|NCT02139826|OG000|Outcome|IX-01 Aqueous Dispersion While Fasting|"Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods~IX-01"
11192592|NCT02139826|OG001|Outcome|IX-01 Capsule While Fasting|"Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods~IX-01"
11192593|NCT02139826|OG002|Outcome|IX-01 Capsule After Food|"Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods~IX-01"
11192594|NCT02139826|EG000|Reported Event|IX-01 Aqueous Dispersion While Fasting|"Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods~IX-01"
11192595|NCT02139826|EG001|Reported Event|IX-01 Capsule While Fasting|"Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods~IX-01"
11192596|NCT02139826|EG002|Reported Event|IX-01 Capsule After Food|"Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods~IX-01"
11192597|NCT02139878|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
11378007|NCT01313689|OG003|Outcome|Ofatumumab Observation (OFA Observ.)|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11192598|NCT02139878|FG000|Participant Flow|Wild Blueberry Juice First, Then Placebo|240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)
11192599|NCT02139878|FG001|Participant Flow|Placebo First, Then Wild Blueberry Juice|240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
11192600|NCT02139878|OG000|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
11192601|NCT02139878|OG001|Outcome|Placebo|240 ml placebo beverage
11192602|NCT02139878|EG000|Reported Event|Wild Blueberry Juice|240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period
11192603|NCT02139878|EG001|Reported Event|Placebo|240 ml Placebo beverage daily in either the first intervention period or second intervention period
11192604|NCT02139943|BG000|Baseline|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
11192605|NCT02139943|BG001|Baseline|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
11192606|NCT02139943|BG002|Baseline|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
11192607|NCT02139943|BG003|Baseline|Total|Total of all reporting groups
11192608|NCT02139943|FG000|Participant Flow|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
11192609|NCT02139943|FG001|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
11192610|NCT02139943|FG002|Participant Flow|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
11192611|NCT02139943|OG000|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
11192612|NCT02139943|OG001|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
11192613|NCT02139943|OG002|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
11192614|NCT02139943|EG000|Reported Event|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
11192615|NCT02139943|EG001|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
11192616|NCT02139943|EG002|Reported Event|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
11192617|NCT02139969|BG000|Baseline|GreenLight XPS Laser System|Treatment of BPH in men using the GreenLight XPS Laser System
11192618|NCT02139969|FG000|Participant Flow|GreenLight XPS Laser System|Treatment of men with BPH using the GreenLight XPS Laser System and the MoXy fiber
11192619|NCT02139969|OG000|Outcome|GreenLight XPS Laser System|Treatment of BPH in men using the GreenLight XPS Laser System
11378008|NCT01313689|OG004|Outcome|OFA First Randomization Only (OFA FRO)|"Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.~Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU."
11378009|NCT01313689|OG005|Outcome|OFA Salvage|The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378010|NCT01313689|OG001|Outcome|Ofatumumab Extended (OFA Ext)|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378011|NCT01313689|OG002|Outcome|Ofatumumab Observation (OFA Observ.)|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378012|NCT01313689|OG003|Outcome|OFA First Randomization Only (OFA FRO)|"Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.~Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU."
11378013|NCT01313689|OG004|Outcome|OFA Salvage|The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378014|NCT01313689|EG000|Reported Event|Any Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378015|NCT01313689|EG001|Reported Event|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378016|NCT01313689|EG002|Reported Event|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11192620|NCT02139969|EG000|Reported Event|GreenLight XPS Laser System|Treatment of BPH in men using the GreenLight XPS Laser System
11192621|NCT02139982|BG000|Baseline|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192622|NCT02139982|BG001|Baseline|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192623|NCT02139982|BG002|Baseline|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192624|NCT02139982|BG003|Baseline|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11378017|NCT01313689|EG003|Reported Event|Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization. Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
11378018|NCT01313689|EG004|Reported Event|Physicians Choice|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive s(ingleagent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU
11378019|NCT01313689|EG005|Reported Event|Ofatumumab Salvage|Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anticancer therapy information was collected in the SFU.
10964193|NCT00876395|BG001|Baseline|Placebo + Paclitaxel + Trastuzumab|Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
10964194|NCT00876395|BG002|Baseline|Total|Total of all reporting groups
11378020|NCT01315353|BG000|Baseline|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378021|NCT01315353|BG001|Baseline|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378022|NCT01315353|BG002|Baseline|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378023|NCT01315353|BG003|Baseline|Total|Total of all reporting groups
11378024|NCT01315353|FG000|Participant Flow|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378025|NCT01315353|FG001|Participant Flow|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378026|NCT01315353|FG002|Participant Flow|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378027|NCT01315353|OG000|Outcome|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378028|NCT01315353|OG001|Outcome|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378029|NCT01315353|OG002|Outcome|Arm C : Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378030|NCT01315353|EG000|Reported Event|Arm A: Immediate Cryotherapy (HPV Test-and-treat)|"Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP.~Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
11378031|NCT01315353|EG001|Reported Event|Arm B: Cytology-based Strategy|"Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
10964195|NCT00876395|FG000|Participant Flow|Everolimus + Paclitaxel + Trastuzumab|Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
10964196|NCT00876395|FG001|Participant Flow|Placebo + Paclitaxel + Trastuzumab|Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
11378032|NCT01315353|EG002|Reported Event|Arm C: Ineligible for Randomization to Arm A or B|"Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study.~Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia."
10964197|NCT00876395|OG000|Outcome|Everolimus + Paclitaxel + Trastuzumab|Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
11378033|NCT01318993|BG000|Baseline|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
11378034|NCT01318993|FG000|Participant Flow|GSK1605786A|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
11378035|NCT01318993|OG000|Outcome|GSK1605786A 500 mg BID|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
11378036|NCT01318993|EG000|Reported Event|GSK1605786A|Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
11378037|NCT01335685|BG000|Baseline|Arm A: Ixazomib 3.0 - 3.7 mg|Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
11378038|NCT01335685|BG001|Baseline|Arm B: Ixazomib 3.0 - 5.5 mg|Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
11378039|NCT01335685|BG002|Baseline|Arm C: Ixazomib 3.0 - 4.0 mg|Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
11378040|NCT01335685|BG003|Baseline|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
11378041|NCT01335685|BG004|Baseline|Total|Total of all reporting groups
11378042|NCT01335685|FG000|Participant Flow|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
11378043|NCT01335685|FG001|Participant Flow|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
11378044|NCT01335685|FG002|Participant Flow|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
11378045|NCT01335685|FG003|Participant Flow|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
11378046|NCT01335685|FG004|Participant Flow|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
11378047|NCT01335685|FG005|Participant Flow|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
11378048|NCT01335685|FG006|Participant Flow|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
10849936|NCT00299182|OG000|Outcome|Arm A 1mcg/kg|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11378049|NCT01335685|FG007|Participant Flow|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
11378050|NCT01335685|OG000|Outcome|Arm A: Ixazomib 3.0 - 3.7 mg|Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
11378051|NCT01335685|OG001|Outcome|Arm B: Ixazomib 3.0 - 5.5 mg|Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
11378052|NCT01335685|OG002|Outcome|Arm C: Ixazomib 3.0 - 4.0 mg|Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
11378053|NCT01335685|OG003|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
11378054|NCT01335685|OG000|Outcome|Arm B: Ixazomib 4.0 mg (RP2D)|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
11378055|NCT01335685|OG000|Outcome|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
11378056|NCT01335685|OG001|Outcome|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
11378057|NCT01335685|OG002|Outcome|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
11378058|NCT01335685|OG003|Outcome|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
11378059|NCT01335685|OG004|Outcome|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
11378060|NCT01335685|OG005|Outcome|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
11378061|NCT01335685|OG006|Outcome|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
11378062|NCT01335685|OG007|Outcome|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
11378063|NCT01335685|EG000|Reported Event|Arm A: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles [34 months]).
11378064|NCT01335685|EG001|Reported Event|Arm A: Ixazomib 3.7 mg|Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles [21 months]).
11378065|NCT01335685|EG002|Reported Event|Arm B: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles [25 months]).
11378066|NCT01335685|EG003|Reported Event|Arm B: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles [58 months]).
11378067|NCT01335685|EG004|Reported Event|Arm B: Ixazomib 5.5 mg|Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles [24 months]).
11378068|NCT01335685|EG005|Reported Event|Arm C: Ixazomib 3.0 mg|Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles [40 months]).
11378069|NCT01335685|EG006|Reported Event|Arm C: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles [24 months]).
11378070|NCT01335685|EG007|Reported Event|Arm D: Ixazomib 4.0 mg|Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles [38 months]).
11192625|NCT02139982|BG004|Baseline|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
10964198|NCT00876395|OG001|Outcome|Placebo + Paclitaxel + Trastuzumab|Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
10964199|NCT00876395|OG000|Outcome|Everolimus 10 mg/Day|Everolimus 10 mg daily
10964200|NCT00876395|OG001|Outcome|Everolimus 5 mg/Day|Everolimus 5 mg daily
10964201|NCT00876395|OG000|Outcome|Everolimus|Everolimus 10 mg/day
10800549|NCT04135937|BG000|Baseline|MESH|"Mobile Evidence-Based Smoking Cessation for Veterans Living with HIV is an intervention that is tailored for participants. It can include cognitive behavioral therapy, relapse-prevention text messaging, and/or pharmacotherapy with nicotine replacement therapy, bupropion, or varenicline.~Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Cognitive Behavioral Therapy: Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention~Nicotine Replacement Therapy: Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).~Relapse Prevention Text Messaging: Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit."
10800550|NCT04135937|FG000|Participant Flow|MESH|"Mobile Evidence-Based Smoking Cessation for Veterans Living with HIV is an intervention that is tailored for participants. It can include cognitive behavioral therapy, relapse-prevention text messaging, and/or pharmacotherapy with nicotine replacement therapy, bupropion, or varenicline.~Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Cognitive Behavioral Therapy: Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention~Nicotine Replacement Therapy: Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).~Relapse Prevention Text Messaging: Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit."
10800551|NCT04135937|OG000|Outcome|MESH|"Mobile Evidence-Based Smoking Cessation for Veterans Living with HIV is an intervention that is tailored for participants. It can include cognitive behavioral therapy, relapse-prevention text messaging, and/or pharmacotherapy with nicotine replacement therapy, bupropion, or varenicline.~Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Cognitive Behavioral Therapy: Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention~Nicotine Replacement Therapy: Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).~Relapse Prevention Text Messaging: Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit."
10850534|NCT00303316|OG001|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10964202|NCT00876395|OG001|Outcome|Everolimus Placebo|Placebo of everolimus 10 mg daily
10964203|NCT00876395|OG000|Outcome|Everolimus + Trastuzumab|Everolimus plus trastuzumab
10964204|NCT00876395|EG000|Reported Event|Everolimus+ Paclitaxel+ Trastuzumab|Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
11192626|NCT02139982|BG005|Baseline|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
11192627|NCT02139982|BG006|Baseline|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
11192628|NCT02139982|BG007|Baseline|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
11192629|NCT02139982|BG008|Baseline|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
11192630|NCT02139982|BG009|Baseline|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
11192631|NCT02139982|BG010|Baseline|Total|Total of all reporting groups
11192632|NCT02139982|FG000|Participant Flow|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192633|NCT02139982|FG001|Participant Flow|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192634|NCT02139982|FG002|Participant Flow|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192635|NCT02139982|FG003|Participant Flow|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192636|NCT02139982|FG004|Participant Flow|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
11192637|NCT02139982|FG005|Participant Flow|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
11192638|NCT02139982|FG006|Participant Flow|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
10800552|NCT04135937|EG000|Reported Event|MESH|"Mobile Evidence-Based Smoking Cessation for Veterans Living with HIV is an intervention that is tailored for participants. It can include cognitive behavioral therapy, relapse-prevention text messaging, and/or pharmacotherapy with nicotine replacement therapy, bupropion, or varenicline.~Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert.~Cognitive Behavioral Therapy: Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention~Nicotine Replacement Therapy: Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).~Relapse Prevention Text Messaging: Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit."
10800553|NCT03989232|BG000|Baseline|Semaglutide 1.0 mg|Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
11192639|NCT02139982|FG007|Participant Flow|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
11192640|NCT02139982|FG008|Participant Flow|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
11192641|NCT02139982|FG009|Participant Flow|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
11192642|NCT02139982|OG000|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192643|NCT02139982|OG001|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192644|NCT02139982|OG002|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192645|NCT02139982|OG003|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192646|NCT02139982|OG000|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
11192647|NCT02139982|OG001|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
11192648|NCT02139982|OG002|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
11192649|NCT02139982|OG003|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
11192650|NCT02139982|OG004|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
10964205|NCT00876395|EG001|Reported Event|Placebo+ Paclitaxel+ Trastuzumab|Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
10964206|NCT00876447|BG000|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964207|NCT00876447|BG001|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964208|NCT00876447|BG002|Baseline|Total|Total of all reporting groups
10964209|NCT00876447|FG000|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964210|NCT00876447|FG001|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964211|NCT00876447|OG000|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964212|NCT00876447|OG001|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964213|NCT00876447|EG000|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 1|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964214|NCT00876447|EG001|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 1|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964215|NCT00876447|EG002|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 2|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964216|NCT00876447|EG003|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 2|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964217|NCT00876447|EG004|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 3|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964218|NCT00876447|EG005|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 3|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964219|NCT00876447|EG006|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 4|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964220|NCT00876447|EG007|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 4|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964221|NCT00876447|EG008|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 5|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964222|NCT00876447|EG009|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 5|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964223|NCT00876447|EG010|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 6|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964224|NCT00876447|EG011|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 6|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
11192651|NCT02139982|OG005|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
11192652|NCT02139982|EG000|Reported Event|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192653|NCT02139982|EG001|Reported Event|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192654|NCT02139982|EG002|Reported Event|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192655|NCT02139982|EG003|Reported Event|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
11192656|NCT02139982|EG004|Reported Event|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
11192657|NCT02139982|EG005|Reported Event|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
11192658|NCT02139982|EG006|Reported Event|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
11192659|NCT02139982|EG007|Reported Event|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
11192660|NCT02139982|EG008|Reported Event|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
11192661|NCT02139982|EG009|Reported Event|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
11192662|NCT02140060|BG000|Baseline|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192663|NCT02140060|BG001|Baseline|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192664|NCT02140060|BG002|Baseline|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192665|NCT02140060|BG003|Baseline|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192666|NCT02140060|BG004|Baseline|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
11192667|NCT02140060|BG005|Baseline|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192668|NCT02140060|BG006|Baseline|Total|Total of all reporting groups
11192669|NCT02140060|FG000|Participant Flow|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
10964225|NCT00876447|EG012|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 7|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964226|NCT00876447|EG013|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 7|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964227|NCT00876447|EG014|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 8|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964228|NCT00876447|EG015|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 8|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
11192670|NCT02140060|FG001|Participant Flow|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
10964229|NCT00876447|EG016|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 9|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10800554|NCT03989232|BG001|Baseline|Semaglutide 2.0 mg|Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
10800555|NCT03989232|BG002|Baseline|Total|Total of all reporting groups
10800556|NCT03989232|FG000|Participant Flow|Semaglutide 1.0 mg|Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
10800557|NCT03989232|FG001|Participant Flow|Semaglutide 2.0 mg|Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
10800558|NCT03989232|OG000|Outcome|Semaglutide 1.0 mg|Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
10800559|NCT03989232|OG001|Outcome|Semaglutide 2.0 mg|Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
10800560|NCT03989232|EG000|Reported Event|Semaglutide 1.0 mg|Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
10800561|NCT03989232|EG001|Reported Event|Semaglutide 2.0 mg|Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
10800562|NCT03896295|BG000|Baseline|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
10800563|NCT03896295|BG001|Baseline|Nipocalimab-Nipocalimab|Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10800564|NCT03896295|BG002|Baseline|Total|Total of all reporting groups
10800565|NCT03896295|FG000|Participant Flow|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
10800566|NCT03896295|FG001|Participant Flow|Nipocalimab-Nipocalimab|Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10964230|NCT00876447|EG017|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 9|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964231|NCT00876447|EG018|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 10|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964232|NCT00876447|EG019|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 10|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
11192671|NCT02140060|FG002|Participant Flow|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192672|NCT02140060|FG003|Participant Flow|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192673|NCT02140060|FG004|Participant Flow|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
11192674|NCT02140060|FG005|Participant Flow|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
10964233|NCT00876447|EG020|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 11|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
11192675|NCT02140060|OG000|Outcome|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192676|NCT02140060|OG001|Outcome|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192677|NCT02140060|OG002|Outcome|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192678|NCT02140060|OG003|Outcome|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
10964234|NCT00876447|EG021|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 11|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964235|NCT00876447|EG022|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 12|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
11192679|NCT02140060|OG004|Outcome|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
11192680|NCT02140060|OG005|Outcome|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192681|NCT02140060|EG000|Reported Event|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192682|NCT02140060|EG001|Reported Event|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192683|NCT02140060|EG002|Reported Event|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192684|NCT02140060|EG003|Reported Event|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192685|NCT02140060|EG004|Reported Event|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
11192686|NCT02140060|EG005|Reported Event|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
11192687|NCT02140060|EG006|Reported Event|Pre-treatment|All subjects who signed an informed consent to participate in the study
11192688|NCT02140164|BG000|Baseline|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
11192689|NCT02140164|FG000|Participant Flow|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
11192690|NCT02140164|OG000|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
10800567|NCT03896295|OG000|Outcome|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
10800568|NCT03896295|OG001|Outcome|Nipocalimab-Nipocalimab|Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10800569|NCT03896295|OG002|Outcome|Nipocalimab (All Participants)|Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10800570|NCT03896295|OG000|Outcome|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10964236|NCT00876447|EG023|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 12|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
11192691|NCT02140164|EG000|Reported Event|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
11192692|NCT02140372|BG000|Baseline|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
11192693|NCT02140372|FG000|Participant Flow|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
11192694|NCT02140372|OG000|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
11192695|NCT02140372|EG000|Reported Event|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
11192696|NCT02140411|BG000|Baseline|Ranibizumab|Ranibizumab 0.5 mg administered as an intravitreal injection
11192697|NCT02140411|FG000|Participant Flow|Ranibizumab|Ranibizumab 0.5 mg administered as an intravitreal injection
11192698|NCT02140411|OG000|Outcome|Ranibizumab|Ranibizumab 0.5 mg administered as an intravitreal injection
11192699|NCT02140411|EG000|Reported Event|Ranibizumab 0.5 mg|Ranibizumab 0.5 mg administered as an intravitreal injection
11192700|NCT02140567|BG000|Baseline|Syncope Prediction|Enrolled participants who performed tilt test and were included in efficacy analysis
11192701|NCT02140567|FG000|Participant Flow|Syncope Prediction Study|All enrolled participants who performed a tilt test.
11192702|NCT02140567|OG000|Outcome|Syncope Prediction (Sensitivity)|Tilt-positive participants included in the efficacy analysis
11192703|NCT02140567|OG000|Outcome|Syncope Prediction (Specificity)|Tilt-negative participants included in the efficacy analysis
11192704|NCT02140567|EG000|Reported Event|Syncope Prediction|Enrolled participants who performed the tilt test
10800571|NCT03896295|OG002|Outcome|Nipocalimab (All Participants)|All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
11192705|NCT02140593|BG000|Baseline|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
11192706|NCT02140593|BG001|Baseline|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
11192707|NCT02140593|BG002|Baseline|Total|Total of all reporting groups
10800572|NCT03896295|OG000|Outcome|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10964237|NCT00876447|EG024|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 13|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
10964238|NCT00876447|EG025|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 13|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
10964239|NCT00876460|BG000|Baseline|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10800573|NCT03896295|OG000|Outcome|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every Q2W.
10800574|NCT03896295|EG000|Reported Event|Placebo-Nipocalimab|Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
10800575|NCT03896295|EG001|Reported Event|Nipocalimab-Nipocalimab|Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
10800576|NCT03213457|BG000|Baseline|Placebo|Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
11192708|NCT02140593|FG000|Participant Flow|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
10800577|NCT03213457|BG001|Baseline|Elagolix / Elagolix + E2/NETA|Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
10800578|NCT03213457|BG002|Baseline|Elagolix + E2/NETA|Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
10800579|NCT03213457|BG003|Baseline|Total|Total of all reporting groups
11192709|NCT02140593|FG001|Participant Flow|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
11192710|NCT02140593|OG000|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
11192711|NCT02140593|OG001|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
11192712|NCT02140593|EG000|Reported Event|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
11192713|NCT02140593|EG001|Reported Event|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
11378071|NCT01336621|BG000|Baseline|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
11378072|NCT01336621|FG000|Participant Flow|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
11378073|NCT01336621|OG000|Outcome|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
10800580|NCT03213457|FG000|Participant Flow|Placebo|Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
11192714|NCT02140645|BG000|Baseline|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192715|NCT02140645|BG001|Baseline|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192716|NCT02140645|BG002|Baseline|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
11192717|NCT02140645|BG003|Baseline|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
11192718|NCT02140645|BG004|Baseline|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
11378074|NCT01336621|OG000|Outcome|Retigabine IR in SFUCP|Participants who withdrew from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP after discontinuation of RTG. This is the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR .
11378075|NCT01336621|OG000|Outcome|Retigabine IR in SFUCP|Participants who withdrew from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP following discontinuation of their retigabine, which is the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR.
11192719|NCT02140645|BG005|Baseline|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
11192720|NCT02140645|BG006|Baseline|Total|Total of all reporting groups
11192721|NCT02140645|FG000|Participant Flow|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192722|NCT02140645|FG001|Participant Flow|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192723|NCT02140645|FG002|Participant Flow|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
11192724|NCT02140645|FG003|Participant Flow|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
11192725|NCT02140645|FG004|Participant Flow|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
11192726|NCT02140645|FG005|Participant Flow|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
11192727|NCT02140645|OG000|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192728|NCT02140645|OG001|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
11192729|NCT02140645|OG002|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
11192730|NCT02140645|OG003|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
11192731|NCT02140645|OG004|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
11192732|NCT02140645|OG005|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
11192733|NCT02140645|EG000|Reported Event|MarketScan|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
10964240|NCT00876460|BG001|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192734|NCT02140762|BG000|Baseline|MenABCWY|Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
11192735|NCT02140762|BG001|Baseline|Placebo/MenACWY|Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
11192736|NCT02140762|BG002|Baseline|Total|Total of all reporting groups
11192737|NCT02140762|FG000|Participant Flow|MenABCWY|Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
11192738|NCT02140762|FG001|Participant Flow|Placebo/MenACWY|Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
11192739|NCT02140762|OG000|Outcome|MenABCWY|Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
11192740|NCT02140762|OG001|Outcome|Placebo/MenACWY|Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
11192741|NCT02140762|OG000|Outcome|MenABCWY|"Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months~MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months."
11192742|NCT02140762|OG001|Outcome|Placebo/MenACWY|"Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months~Placebo: 0.5 mL saline solution (IM)~MenACWY: Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months."
11192743|NCT02140762|OG001|Outcome|Placebo/MenACWY|Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months.
11192744|NCT02140762|OG000|Outcome|MenABCWY|Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose after visit month 2
11192745|NCT02140762|OG001|Outcome|Placebo/MenACWY|Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2
11192746|NCT02140762|EG000|Reported Event|MenABCWY|Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
11192747|NCT02140762|EG001|Reported Event|Placebo/MenACWY|Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
11192748|NCT02140775|BG000|Baseline|Behavioral Activation Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
11192749|NCT02140775|BG001|Baseline|Supportive Counseling|Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks. The content of the sessions will be guided by the participant. The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
10800581|NCT03213457|FG001|Participant Flow|Elagolix / Elagolix + E2/NETA|Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
10800582|NCT03213457|FG002|Participant Flow|Elagolix + E2/NETA|Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
10800583|NCT03213457|OG000|Outcome|Placebo|Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
11192750|NCT02140775|BG002|Baseline|Total|Total of all reporting groups
10800584|NCT03213457|OG001|Outcome|Elagolix + E2/NETA|Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
10800585|NCT03213457|OG001|Outcome|Elagolix + E2/NETA|Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA [1 mg/0.5 mg] QD for the remaining 36 months of the Treatment Period.
10800586|NCT03213457|EG000|Reported Event|Placebo|Placebo for the 12-month placebo-controlled Treatment Period.
10800587|NCT03213457|EG001|Reported Event|Elagolix / Elagolix + E2/NETA|Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months.
10800588|NCT03213457|EG002|Reported Event|Elagolix + E2/NETA|Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period.
10803646|NCT02878603|FG001|Participant Flow|Caplacizumab (Treated in Study C301)|Participants who completed study ALX0681-C301 and received caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to IMP, withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg IV dose followed by a daily 10 mg SC injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10803647|NCT02878603|OG000|Outcome|Standard of Care (SoC) (Treated in Study C301)|Participants who completed study ALX0681-C301 with SoC (plasma exchange [PE], corticosteroid and other immunosuppressive agents) treatment were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product [IMP], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg intravenous (IV) dose followed by a daily 10 milligrams (mg) subcutaneous (SC) injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10803648|NCT02878603|OG001|Outcome|Caplacizumab (Treated in Study C301)|Participants who completed study ALX0681-C301 and received caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to IMP, withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg IV dose followed by a daily 10 mg SC injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10964241|NCT00876460|BG002|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192751|NCT02140775|FG000|Participant Flow|Behavioral Activation (BA) Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
11192752|NCT02140775|FG001|Participant Flow|Supportive Counseling (SC)|Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks. The content of the sessions will be guided by the participant. The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
11341075|NCT03674281|EG000|Reported Event|Older Adults:SAP|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~e 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6)."
11192753|NCT02140775|OG000|Outcome|Behavioral Activation Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
10800589|NCT02982720|BG000|Baseline|Pembrolizumab and Sylatron|"Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.~Pembrolizumab: Pembrolizumab will be administered intravenously.~Sylatron: Sylatron will be administered subcutaneously."
11378076|NCT01336621|EG000|Reported Event|Retigabine IR|Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
11378077|NCT01336621|EG001|Reported Event|Retigabine IR in SFUCP|Participants who withdrew from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP following discontinuation of their retigabine, which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR .
11378078|NCT04391036|BG000|Baseline|High Eudragit® Film, Then Low Eudragit® Film|"High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11192754|NCT02140775|OG001|Outcome|Supportive Counseling|Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks. The content of the sessions will be guided by the participant. The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
11192755|NCT02140775|OG000|Outcome|Behavioral Activation (BA) Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
11192756|NCT02140775|OG001|Outcome|Supportive Counseling (SC)|Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks. The content of the sessions will be guided by the participant. The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
11192757|NCT02140775|EG000|Reported Event|Behavioral Activation Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment.
11192758|NCT02140775|EG001|Reported Event|Supportive Counseling|Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks. The content of the sessions will be guided by the participant. The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
11192759|NCT02140957|BG000|Baseline|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202150|NCT02205476|EG000|Reported Event|Group 1: PF--06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11378079|NCT04391036|BG001|Baseline|Low Eudragit® Film, Then High Eudragit® Film|"Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11378080|NCT04391036|BG002|Baseline|Total|Total of all reporting groups
11202151|NCT02205476|EG001|Reported Event|Group 2: PF--06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11378081|NCT04391036|FG000|Participant Flow|High Eudragit® Film, Then Low Eudragit® Film|"High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11202152|NCT02205801|BG000|Baseline|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
11378082|NCT04391036|FG001|Participant Flow|Low Eudragit® Film, Then High Eudragit® Film|"Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11378083|NCT04391036|OG000|Outcome|High Eudragit® Film|High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
11202153|NCT02205801|BG001|Baseline|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11378084|NCT04391036|OG001|Outcome|Low Eudragit® Film|Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
11192760|NCT02140957|BG001|Baseline|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11192761|NCT02140957|BG002|Baseline|Total|Total of all reporting groups
11192762|NCT02140957|FG000|Participant Flow|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202154|NCT02205801|BG002|Baseline|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
10800590|NCT02982720|FG000|Participant Flow|Pembrolizumab and Sylatron|"Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.~Pembrolizumab: Pembrolizumab will be administered intravenously.~Sylatron: Sylatron will be administered subcutaneously."
10800591|NCT02982720|OG000|Outcome|Pembrolizumab and Sylatron|"Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.~Pembrolizumab: Pembrolizumab will be administered intravenously.~Sylatron: Sylatron will be administered subcutaneously."
10800592|NCT02982720|EG000|Reported Event|Pembrolizumab and Sylatron|"Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.~Pembrolizumab: Pembrolizumab will be administered intravenously.~Sylatron: Sylatron will be administered subcutaneously."
10800593|NCT02548754|BG000|Baseline|Active|"Patients will receive 1 hour of active low level tragus stimulation daily for 6 months~Parasym device"
10800594|NCT02548754|BG001|Baseline|Sham|"Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months~Parasym device"
10800595|NCT02548754|BG002|Baseline|Total|Total of all reporting groups
10800596|NCT02548754|FG000|Participant Flow|Active|"Patients will receive 1 hour of active low level tragus stimulation daily for 6 months~Parasym device"
10800597|NCT02548754|FG001|Participant Flow|Sham|"Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months~Parasym device"
10800598|NCT02548754|OG000|Outcome|Active|"Patients will receive 1 hour of active low level tragus stimulation daily for 6 months~Parasym device"
10800599|NCT02548754|OG001|Outcome|Sham|"Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months~Parasym device"
10800600|NCT02548754|EG000|Reported Event|Active|"Patients will receive 1 hour of active low level tragus stimulation daily for 6 months~Parasym device"
10800601|NCT02548754|EG001|Reported Event|Sham|"Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months~Parasym device"
10800602|NCT02375672|BG000|Baseline|Pembrolizumab (MK-3475) + mFOLFOX6|"Following the safety run-in cohort:~mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)~Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks~mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)~Oxaliplatin 85 mg/m^2 IV with~Leucovorin 400 mg/m^2 IV followed by~5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion"
10800603|NCT02375672|FG000|Participant Flow|Pembrolizumab (MK-3475) + mFOLFOX6|"Following the safety run-in cohort:~mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)~Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks~mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)~Oxaliplatin 85 mg/m^2 IV with~Leucovorin 400 mg/m^2 IV followed by~5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion"
10800604|NCT02375672|OG000|Outcome|Pembrolizumab (MK-3475) + mFOLFOX6|"Following the safety run-in cohort:~mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)~Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks~mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)~Oxaliplatin 85 mg/m^2 IV with~Leucovorin 400 mg/m^2 IV followed by~5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion"
10800605|NCT02375672|EG000|Reported Event|Pembrolizumab (MK-3475) + mFOLFOX6|"Following the safety run-in cohort:~mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)~Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks~mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)~Oxaliplatin 85 mg/m^2 IV with~Leucovorin 400 mg/m^2 IV followed by~5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion"
10800606|NCT02329327|BG000|Baseline|Andexanet|Participants received andexanet as an intravenous (IV) bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
11202155|NCT02205801|BG003|Baseline|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11202156|NCT02205801|BG004|Baseline|Total|Total of all reporting groups
10964242|NCT00876460|BG003|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10800607|NCT02329327|BG001|Baseline|Andexanet - Additional Participants|Two additional participants received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800608|NCT02329327|BG002|Baseline|Total|Total of all reporting groups
10800609|NCT02329327|FG000|Participant Flow|Andexanet|Participants received andexanet as an intravenous (IV) bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800610|NCT02329327|FG001|Participant Flow|Andexanet - Additional Participants|Two additional participants received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800611|NCT02329327|OG000|Outcome|FXa Inhibitor: Apixaban|Participants who had recently received FXa inhibitor apixaban received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800612|NCT02329327|OG001|Outcome|FXa Inhibitor: Rivaroxaban|Participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800613|NCT02329327|OG002|Outcome|FXa Inhibitor: Edoxaban|Participants who had recently received FXa inhibitor edoxaban received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800614|NCT02329327|OG003|Outcome|FXa Inhibitor: Enoxaparin|Participants who had recently received FXa inhibitor enoxaparin received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800615|NCT02329327|OG004|Outcome|FXa Inhibitor: Rivaroxaban - Additional Participants|Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800616|NCT02329327|OG004|Outcome|Bleed Type: Gastrointestinal|Participants with gastrointestinal bleeding who had recently received an FXa inhibitor received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800617|NCT02329327|OG005|Outcome|Bleed Type: Intracranial Hemorrhage|Participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800618|NCT02329327|OG006|Outcome|Bleed Type: Other|Participants with other types of bleeding who had recently received an FXa inhibitor received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
10800619|NCT02329327|OG007|Outcome|Andexanet: Low Dose|Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over ~120 minutes.
10800620|NCT02329327|OG008|Outcome|Andexanet: High Dose|Participants who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over ~120 minutes.
10800621|NCT02329327|OG009|Outcome|Overall|Participants who had recently received FXa inhibitor received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Does not include the 2 additional participants whose data were obtained and evaluated after the data cutoff date of 30-June-2020.
10800622|NCT02329327|OG010|Outcome|FXa Inhibitor: Rivaroxaban - Additional Participants|Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800623|NCT02329327|OG011|Outcome|Bleed Type: Intracranial Hemorrhage - Additional Participants|Two additional participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800624|NCT02329327|OG012|Outcome|Andexanet: Low Dose - Additional Participant|One additional participant who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over ~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800625|NCT02329327|OG013|Outcome|Andexanet: High Dose - Additional Participant|One additional participant who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over ~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
10800626|NCT02329327|EG000|Reported Event|Andexanet: Low Dose|Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over ~120 minutes.
10800627|NCT02329327|EG001|Reported Event|Andexanet: High Dose|Participants who had recently received FXa inhibitors received andexanet as an IV 800- mg bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over ~120 minutes.
10800628|NCT02153645|BG000|Baseline|240mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
10800629|NCT02153645|BG001|Baseline|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.~Amantadine ER Tablets"
10800630|NCT02153645|BG002|Baseline|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.~Placebo Tablets for Amantadine ER Tablets"
10800631|NCT02153645|BG003|Baseline|Total|Total of all reporting groups
10800632|NCT02153645|FG000|Participant Flow|240mg Amantadine Hydrochloride (HCl) ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
11192763|NCT02140957|FG001|Participant Flow|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202157|NCT02205801|FG000|Participant Flow|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
11192764|NCT02140957|OG000|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202158|NCT02205801|FG001|Participant Flow|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11192765|NCT02140957|OG001|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202159|NCT02205801|FG002|Participant Flow|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
11202160|NCT02205801|FG003|Participant Flow|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11202161|NCT02205801|OG000|Outcome|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
10800633|NCT02153645|FG001|Participant Flow|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.~Amantadine ER Tablets"
11192766|NCT02140957|EG000|Reported Event|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
11202162|NCT02205801|OG001|Outcome|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11202163|NCT02205801|OG002|Outcome|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
10800634|NCT02153645|FG002|Participant Flow|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.~Placebo Tablets for Amantadine ER Tablets"
11192767|NCT02140957|EG001|Reported Event|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
10800635|NCT02153645|OG000|Outcome|240 mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240 mg daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
10800636|NCT02153645|OG001|Outcome|320 mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320 mg daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
10800637|NCT02153645|OG002|Outcome|Placebo Amantadine HCl ER Tablets|"Amantadine HCl ER Placebo Tablets daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
10800638|NCT02153645|EG000|Reported Event|240mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.~Amantadine ER Tablets"
10800639|NCT02153645|EG001|Reported Event|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.~Amantadine ER Tablets"
10800640|NCT02153645|EG002|Reported Event|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.~Placebo Tablets for Amantadine ER Tablets"
10800641|NCT02153632|BG000|Baseline|240mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800642|NCT02153632|BG001|Baseline|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800643|NCT02153632|BG002|Baseline|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.~Placebo"
11192768|NCT02140970|BG000|Baseline|Liquid Ibuprofen|"10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal~Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal"
11192769|NCT02140970|BG001|Baseline|Liquid Placebo|"Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal~Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal"
11192770|NCT02140970|BG002|Baseline|Total|Total of all reporting groups
11192771|NCT02140970|FG000|Participant Flow|Liquid Ibuprofen|"10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal~Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal"
11192772|NCT02140970|FG001|Participant Flow|Liquid Placebo|"Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal~Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal"
11192773|NCT02140970|OG000|Outcome|Liquid Ibuprofen|"10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal~Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal"
10800644|NCT02153632|BG003|Baseline|Total|Total of all reporting groups
10800645|NCT02153632|FG000|Participant Flow|240mg Amantadine HCl ER Tablets|"Amantadine Hydrogen Chloride (HCl) ER Tablets 240mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800646|NCT02153632|FG001|Participant Flow|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800647|NCT02153632|FG002|Participant Flow|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.~Placebo"
10800648|NCT02153632|OG000|Outcome|240mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800649|NCT02153632|OG001|Outcome|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800650|NCT02153632|OG002|Outcome|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.~Placebo"
10800651|NCT02153632|EG000|Reported Event|240mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 240mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800652|NCT02153632|EG001|Reported Event|320mg Amantadine HCl ER Tablets|"Amantadine HCl ER Tablets 320mg daily for 22 weeks post two week titration phase.~Amantadine HCl ER (ALLAY-LID II)"
10800653|NCT02153632|EG002|Reported Event|Placebo Tablets for Amantadine|"Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 26 weeks.~Placebo"
10800654|NCT01689909|BG000|Baseline|Zolpidem-CR|"Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks~Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800655|NCT01689909|BG001|Baseline|Placebo|"Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks~Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800656|NCT01689909|BG002|Baseline|Total|Total of all reporting groups
10800657|NCT01689909|FG000|Participant Flow|Zolpidem-CR|"Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks~Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800658|NCT01689909|FG001|Participant Flow|Placebo|"Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks~Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800659|NCT01689909|OG000|Outcome|Zolpidem-CR|"Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks~Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800660|NCT01689909|OG001|Outcome|Placebo|"Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks~Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800661|NCT01689909|OG000|Outcome|Scale for Suicide Ideation Score Greater Than or Equal to 6|Participants with a baseline Scale for Suicide Ideation Score Greater than or Equal to 6
10800662|NCT01689909|OG001|Outcome|Scale for Suicide Ideation Score Less Than 6|Participants with Scale for Suicide Ideation Score less than 6
11192774|NCT02140970|OG001|Outcome|Liquid Placebo|"Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal~Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal"
11192775|NCT02140970|EG000|Reported Event|Liquid Ibuprofen|"10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal~Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal"
11192776|NCT02140970|EG001|Reported Event|Liquid Placebo|"Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal~Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal"
11192777|NCT02141204|BG000|Baseline|HRV Liq Group|Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192778|NCT02141204|BG001|Baseline|HRV Lyo Group|Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192779|NCT02141204|BG002|Baseline|Total|Total of all reporting groups
10800663|NCT01689909|EG000|Reported Event|Zolpidem-CR|"Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks~Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks"
11192780|NCT02141204|FG000|Participant Flow|HRV Liq Group|Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11378085|NCT04391036|OG000|Outcome|High Eudragit® Film, Then Low Eudragit® Film|"High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11378086|NCT04391036|OG001|Outcome|Low Eudragit® Film, Then High Eudragit® Film|"Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
11378087|NCT04391036|EG000|Reported Event|High Eudragit® Film, Then Low Eudragit® Film|"High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
10800664|NCT01689909|EG001|Reported Event|Placebo|"Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks~Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks"
10800665|NCT01566149|BG000|Baseline|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
10800666|NCT01566149|BG001|Baseline|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
10800667|NCT01566149|BG002|Baseline|Total|Total of all reporting groups
10800668|NCT01566149|FG000|Participant Flow|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
10800669|NCT01566149|FG001|Participant Flow|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
10800670|NCT01566149|OG000|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
10800671|NCT01566149|OG001|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
10800672|NCT01566149|EG000|Reported Event|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
10800673|NCT01566149|EG001|Reported Event|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
10800674|NCT01481935|BG000|Baseline|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800675|NCT01481935|BG001|Baseline|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800676|NCT01481935|BG002|Baseline|Total|Total of all reporting groups
10800677|NCT01481935|FG000|Participant Flow|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800678|NCT01481935|FG001|Participant Flow|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800679|NCT01481935|OG000|Outcome|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800680|NCT01481935|OG001|Outcome|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800681|NCT01481935|EG000|Reported Event|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800682|NCT01481935|EG001|Reported Event|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
10800683|NCT01386125|BG000|Baseline|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
10800684|NCT01386125|BG001|Baseline|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
10800685|NCT01386125|BG002|Baseline|Total|Total of all reporting groups
10800686|NCT01386125|FG000|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
10800687|NCT01386125|FG001|Participant Flow|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
10800688|NCT01386125|OG000|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
10800689|NCT01386125|OG001|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
10800690|NCT01386125|EG000|Reported Event|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
10800691|NCT01386125|EG001|Reported Event|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
10800692|NCT01257568|BG000|Baseline|Rejuvenate Modular Hip System|All subjects who received the Rejuvenate Modular stem/neck.
10800693|NCT01257568|FG000|Participant Flow|Rejuvenate Modular Hip System|Participants who received the Rejuvenate Modular stem/neck can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
10800694|NCT01257568|OG000|Outcome|Rejuvenate Modular Hip System|"Rejuvenate Modular Hip~Rejuvenate Modular Hip: Rejuvenate Modular Hip"
11378088|NCT04391036|EG001|Reported Event|Low Eudragit® Film, Then High Eudragit® Film|"Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film~High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film~Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film"
10800695|NCT01257568|OG000|Outcome|Rejuvenate Modular Hip System|Participants who received the Rejuvenate Modular stem/neck.
10800696|NCT01257568|EG000|Reported Event|Operative Adverse Events|Rejuvenate Modular Stem/Neck. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
10800697|NCT01257568|EG001|Reported Event|Non-Operative Adverse Events|Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant.
11192781|NCT02141204|FG001|Participant Flow|HRV Lyo Group|Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192782|NCT02141204|OG000|Outcome|HRV Liq Group|Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192783|NCT02141204|OG001|Outcome|HRV Lyo Group|Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192784|NCT02141204|EG000|Reported Event|HRV Liq Group|Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192785|NCT02141204|EG001|Reported Event|HRV Lyo Group|Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1.
11192786|NCT02141217|BG000|Baseline|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378089|NCT04170296|BG000|Baseline|Cohort 1: Posterolateral Thigh|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378090|NCT04170296|BG001|Baseline|Cohort 2: Buttocks|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378091|NCT04170296|BG002|Baseline|Total|Total of all reporting groups
11378092|NCT04170296|FG000|Participant Flow|Cohort 1: Posterolateral Thigh|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378093|NCT04170296|FG001|Participant Flow|Cohort 2: Buttocks|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378094|NCT04170296|OG000|Outcome|Cohort 1: Posterolateral Thigh|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378095|NCT04170296|OG000|Outcome|Cohort 2: Buttocks|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378096|NCT04170296|OG000|Outcome|Cohort 2: Buttocks (Left)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378097|NCT04170296|OG001|Outcome|Cohort 2: Buttocks (Right)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378098|NCT04170296|OG000|Outcome|Cohort 1: Posterolateral Thigh (Anti AUX-I)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378099|NCT04170296|OG001|Outcome|Cohort 1: Posterolateral Thigh (Anti AUX-II)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378100|NCT04170296|OG000|Outcome|Cohort 2: Buttocks (Anti AUX-I)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378101|NCT04170296|OG001|Outcome|Cohort 2: Buttocks (Anti AUX-II)|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11192787|NCT02141217|BG001|Baseline|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378102|NCT04170296|EG000|Reported Event|Cohort 1: Posterolateral Thigh|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378103|NCT04170296|EG001|Reported Event|Cohort 2: Buttocks|"EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)~EN3835: Collagenase Clostridium Histolyticum (CCH)"
11378104|NCT04039217|BG000|Baseline|Biktarvy|Participants were given two doses of the oral fixed dose combination anti-HIV medication Biktarvy (BIC/FTC/TAF) separated by 24 hours, and had specimens collected at different time points.
11378105|NCT04039217|FG000|Participant Flow|Biktarvy|"Participants were given 2 doses of the oral fixed dose combination anti-HIV medication Biktarvy (BIC/FTC/TAF) separated by 24 hours, and had specimens collected at different time points.~Arm A.1: blood collection occurred 2, 48, and 96 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 2 hours after the in-clinic dose of Biktarvy~Arm A.2: blood collection occurred 2, 48, and 96 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 48 hours after the in-clinic dose of Biktarvy~Arm A.3: blood collection occurred 2, 48, and 96 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 96 hours after the in-clinic dose of Biktarvy~Arm B.1: blood collection occurred 4, 26, and 120 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 4 hours after the in-clinic dose of Biktarvy~Arm B.2: blood collection occurred 4, 26, and 120 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 120 hours after the in-clinic dose of Biktarvy~Arm C.1: blood collection occurred 24, 28, and 72 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 24 hours after the in-clinic dose of Biktarvy~Arm C.2: blood collection occurred 24, 28, and 72 hours after the in-clinic dose of Biktarvy; rectal biopsy occurred 72 hours after the in-clinic dose of Biktarvy"
11378106|NCT04039217|OG000|Outcome|Sample Collection 2, 48, and 96 Hours After First Dose of Biktarvy|Participants in study Arm A provided biological specimens 2, 48, and 96 hours after the in-clinic dose of Biktarvy. Participants had a rectal biopsy at one of the study visits.
11378107|NCT04039217|OG001|Outcome|Sample Collection 4, 26, and 120 Hours After First Dose of Biktarvy|Participants in study Arm B provided biological specimens 4, 26, and 120 hours after the in-clinic dose of Biktarvy. Participants also had a rectal biopsy at one of the study visits.
11378108|NCT04039217|OG002|Outcome|Sample Collection 24, 28, and 72 Hours After First Dose of Biktarvy|Participants in study Arm C will provide biological specimens 24, 28, and 72 hours after the in-clinic dose of Biktarvy. Participants also had a rectal biopsy at one of the study visits.
11378109|NCT04039217|EG000|Reported Event|Sample Collection 2, 48, and 96 Hours After First Dose of Biktarvy|Participants in study arm A provided biological specimens 2, 48, and 96 hours after the in-clinic dose of Biktarvy. Participants had a rectal biopsy at one of the study visits.
11378110|NCT04039217|EG001|Reported Event|Sample Collection 4, 26, and 120 Hours After First Dose of Biktarvy|Participants in study arm B provided biological specimens 4, 26, and 120 hours after the in-clinic dose of Biktarvy. Participants also had a rectal biopsy at one of the study visits.
11378111|NCT04039217|EG002|Reported Event|Sample Collection 24, 28, and 72 Hours After First Dose of Biktarvy|Participants in study arm C will provide biological specimens 24, 28, and 72 hours after the in-clinic dose of Biktarvy. Participants also had a rectal biopsy at one of the study visits.
11378112|NCT03998046|BG000|Baseline|Basic Resources and Services|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
11378113|NCT03998046|BG001|Baseline|Coordinated Primary Care Population Management (C3PO)|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
11378114|NCT03998046|BG002|Baseline|Total|Total of all reporting groups
11192788|NCT02141217|BG002|Baseline|Total|Total of all reporting groups
11192789|NCT02141217|FG000|Participant Flow|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11192790|NCT02141217|FG001|Participant Flow|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11192791|NCT02141217|OG000|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378115|NCT03998046|FG000|Participant Flow|Basic Resources and Services|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
11378116|NCT03998046|FG001|Participant Flow|Coordinated Primary Care Population Management (C3PO)|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
11378117|NCT03998046|OG000|Outcome|Basic Resources and Services|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
11378118|NCT03998046|OG001|Outcome|Coordinated Primary Care Population Management (C3PO)|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
11378119|NCT03998046|OG000|Outcome|Basic Resources and Services|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
11378120|NCT03998046|EG000|Reported Event|Basic Resources and Services|Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
11378121|NCT03998046|EG001|Reported Event|Coordinated Primary Care Population Management (C3PO)|"Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.~."
11378122|NCT03160521|BG000|Baseline|Risperidone ISM 75 mg|"Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 75 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378123|NCT03160521|BG001|Baseline|Risperidone ISM 100 mg|"Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378124|NCT03160521|BG002|Baseline|Placebo|"Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.~Placebo of Risperidone ISM: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378125|NCT03160521|BG003|Baseline|Total|Total of all reporting groups
11378126|NCT03160521|FG000|Participant Flow|Risperidone in Situ Microparticle (ISM) 75 mg|"Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 75 mg: Monthly IM intramuscular (IM) injection in the gluteal or deltoid muscle."
11378127|NCT03160521|FG001|Participant Flow|Risperidone ISM 100 mg|"Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 100 mg: Monthly IM injection in the gluteal or deltoid muscle."
11378128|NCT03160521|FG002|Participant Flow|Placebo|"Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.~Placebo of Risperidone ISM: Monthly IM injection in the gluteal or deltoid muscle."
11378129|NCT03160521|OG000|Outcome|Risperidone ISM 75 mg|"Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 75 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378130|NCT03160521|OG001|Outcome|Risperidone ISM 100 mg|"Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378131|NCT03160521|OG002|Outcome|Placebo|"Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.~Placebo of Risperidone ISM: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378132|NCT03160521|OG000|Outcome|Risperidone ISM 75 mg|"Patients assigned to this arm will received Risperidone ISM 75 mg during double-blind treatment period.~Risperidone ISM 75 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378133|NCT03160521|OG001|Outcome|Risperidone ISM 100 mg|"Patients assigned to this arm will received Risperidone ISM 100 mg during double-blind treatment period.~Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378134|NCT03160521|OG000|Outcome|Risperidone ISM|"Patients assigned to this arm will received Risperidone ISM (either 75 or 100 mg) during double-blind treatment period.~Risperidone ISM (either 75 or 100 mg): Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378135|NCT03160521|OG001|Outcome|Placebo|"Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.~Placebo of Risperidone ISM: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378136|NCT03160521|OG000|Outcome|Risperidone ISM 75 mg|Risperidone ISM 75 mg dose
11192792|NCT02141217|OG001|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378137|NCT03160521|OG001|Outcome|Risperidone ISM 100 mg|Risperidone ISM 100 mg dose
10800698|NCT01165424|BG000|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
11192793|NCT02141217|OG000|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
11192794|NCT02141217|OG001|Outcome|Clindamycin 150 mg|Participants randomized to clindamycin 150 mg.
11192795|NCT02141217|OG000|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378138|NCT03160521|EG000|Reported Event|Risperidone ISM 75 mg|"Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 75 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378139|NCT03160521|EG001|Reported Event|Risperidone ISM 100 mg|"Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.~Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378140|NCT03160521|EG002|Reported Event|Placebo|"Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.~Placebo of Risperidone ISM: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11378141|NCT03143816|BG000|Baseline|Technosphere Insulin (TI, Afrezza) -Treatment Arm|This group received Technosphere insulin for bolus insulin with meals and corrections
11378142|NCT03143816|BG001|Baseline|Insulin Aspart ( Novolog) -Control Arm|This group received insulin aspart for bolus insulin with meals and corrections
11378143|NCT03143816|BG002|Baseline|Total|Total of all reporting groups
11378144|NCT03143816|FG000|Participant Flow|Technosphere Insulin (TI, Afrezza) -Treatment Arm|There were a total of seven clinic and phone visits during the study period.Patients were randomized 1:1 to TI or insulin aspart group using a blocked design, stratified by screening HbA1c (<8% or >8%).All patients used realtime CGM (continuous glucose monitor) during the study period. Patients randomized to aspart continued the same bolus regimen as used before randomization. If patients were using any other RAIA( rapid acting insulin analog) (other than aspart), they were switched to aspart on the same dose at the randomization visit. Patients in the aspart group were also allowed to change their premeal bolus dose and take postprandial and other correction doses as deemed clinically necessary.
11378145|NCT03143816|FG001|Participant Flow|Aspart ( Control)|There were a total of seven clinic and phone visits during the study period.Patients were randomized 1:1 to TI or insulin aspart group using a blocked design, stratified by screening HbA1c (<8% or >8%).All patients used realtime CGM (continuous glucose monitor) during the study period. Patients randomized to aspart continued the same bolus regimen as used before randomization. If patients were using any other RAIA ( rapid acting insulin analog) (other than aspart), they were switched to aspart on the same dose at the randomization visit. Patients in the aspart group were alsoallowed to change their premeal bolus dose and take postprandial and other correction doses as deemed clinically necessary.
11378146|NCT03143816|OG000|Outcome|Insulin Aspart ( Novolog) -Control Arm|Group received insulin aspart as bolus
11192796|NCT02141217|EG000|Reported Event|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11378147|NCT03143816|OG001|Outcome|Technosphere Insulin (TI, Afrezza) -Treatment Arm|Group received Technosphere insulin as bolus
11378148|NCT03143816|OG000|Outcome|Technosphere Insulin (TI, Afrezza) -Treatment Arm|Group using Technosphere insulin
11378149|NCT03143816|OG001|Outcome|Insulin Aspart ( Novolog) -Control Arm|Group using novolog ( control ) group
11378150|NCT03143816|OG000|Outcome|Technosphere Insulin (TI, Afrezza) -Treatment Arm|Group using Technosphere insulin as bolus
11378151|NCT03143816|OG001|Outcome|Insulin Aspart ( Novolog) -Control Arm|Group using insulin aspart as bolus
11378152|NCT03143816|OG000|Outcome|Technosphere Insulin (TI, Afrezza) -Treatment Arm|The group receiving Technosphere insulin
11378153|NCT03143816|OG001|Outcome|Insulin Aspart ( Novolog) -Control Arm|The group receiving insulin aspart (control)
11378154|NCT03143816|EG000|Reported Event|Technosphere Insulin (TI, Afrezza) -Treatment Arm|Group using Technosphere insulin as bolus
11378155|NCT03143816|EG001|Reported Event|Insulin Aspart ( Novolog) -Control Arm|Group using insulin aspart as bolus
11378156|NCT03078192|BG000|Baseline|PVD, Left Heart Disease, Lung Disease|"Patients with Pulmonary Vascular Disease (10 subjects), isolated left-sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378157|NCT03078192|BG001|Baseline|Pulmonary Vascular Disease|"92 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378158|NCT03078192|BG002|Baseline|Total|Total of all reporting groups
11378159|NCT03078192|FG000|Participant Flow|PVD, Left Heart Disease, Lung Disease|"The study team recruited 30 subjects. Patients with Pulmonary Vascular Disease (10 subjects), isolated left-sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378160|NCT03078192|FG001|Participant Flow|Pulmonary Vascular Disease|"the study team recuited 32 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378161|NCT03078192|OG000|Outcome|Training Set - PVD, Isolated Left Heart Disease, Lung Disease|"The study recruited 30 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378162|NCT03078192|OG001|Outcome|Test Set - Pulmonary Vascular Disease|"The study recruited 32 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378163|NCT03078192|EG000|Reported Event|PVD, Left Heart Disease, Lung Disease|"Patients with Pulmonary Vascular Disease (10 subjects), isolated left sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11378164|NCT03078192|EG001|Reported Event|Pulmonary Vascular Disease|"92 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD~GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe~MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon"
11240896|NCT02482675|FG014|Participant Flow|Whey Protein, Then Milk, Then Sodium Caseinate, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
10800699|NCT01165424|FG000|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
10800700|NCT01165424|OG000|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
11378165|NCT02959944|BG000|Baseline|Ibrutinib + Prednisone|"Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for CYP inhibitors or hepatic dysfunction as applicable.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378166|NCT02959944|BG001|Baseline|Placebo + Prednisone|"Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378167|NCT02959944|BG002|Baseline|Total|Total of all reporting groups
11378168|NCT02959944|FG000|Participant Flow|Ibrutinib + Prednisone|"Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 [CYP] inhibitors or hepatic dysfunction as applicable.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378169|NCT02959944|FG001|Participant Flow|Placebo + Prednisone|"Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378170|NCT02959944|OG000|Outcome|Ibrutinib + Prednisone|"Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for CYP inhibitors or hepatic dysfunction as applicable.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378171|NCT02959944|OG001|Outcome|Placebo + Prednisone|"Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378172|NCT02959944|EG000|Reported Event|Ibrutinib|"Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 [CYP] inhibitors or hepatic dysfunction as applicable.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378173|NCT02959944|EG001|Reported Event|Placebo|"Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity.~Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses."
11378174|NCT02903823|BG000|Baseline|Baclofen Injection at Designated Spinal Level|"Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T4, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.~Baclofen bolus injection: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location."
11378175|NCT02903823|FG000|Participant Flow|Baclofen Injection at Designated Spinal Level|"Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T4, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.~Baclofen bolus injection: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location."
11378176|NCT02903823|OG000|Outcome|Subjects With Max MAS Change|"Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.~Baclofen bolus injection: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location."
11378177|NCT02903823|OG000|Outcome|Subjects With MAS Change - Based on Site of Injection|"Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.~Baclofen bolus injection: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location."
11378178|NCT02903823|EG000|Reported Event|Baclofen Injection at Designated Spinal Level|"Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T3, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.~Baclofen bolus injection: A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location."
11378179|NCT02666183|BG000|Baseline|Closer|"The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in real time during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers~Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support"
11378180|NCT02666183|BG001|Baseline|Video-C Only|"This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be delivered systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in real time during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers"
11378181|NCT02666183|BG002|Baseline|Web-Only|"This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association, etc.), b)Resources for DCGs (links to the Caregiving from a Distance, etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.~Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information"
11378182|NCT02666183|BG003|Baseline|Total|Total of all reporting groups
11378183|NCT02666183|FG000|Participant Flow|Closer|"The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in real time during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers~Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support"
11378184|NCT02666183|FG001|Participant Flow|Video-C Only|"This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be delivered systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in real time during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers"
11378185|NCT02666183|FG002|Participant Flow|Web-Only|"This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association, etc.), b)Resources for DCGs (links to the Caregiving from a Distance, etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.~Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information"
11339495|NCT03631433|BG001|Baseline|Ibuprofen/Acetaminophen|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen"
11192797|NCT02141217|EG001|Reported Event|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
11339496|NCT03631433|BG002|Baseline|Total|Total of all reporting groups
11339497|NCT03631433|FG000|Participant Flow|Ibuprofen|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen"
11339498|NCT03631433|FG001|Participant Flow|Ibuprofen/Acetaminophen Combination|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen"
11339499|NCT03631433|OG000|Outcome|Ibuprofen|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen"
11339500|NCT03631433|OG001|Outcome|Ibuprofen/Acetaminophen Combination|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen"
11339501|NCT03631433|EG000|Reported Event|Ibuprofen|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen"
11339502|NCT03631433|EG001|Reported Event|Ibuprofen/Acetaminophen Combination|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen"
11339503|NCT03631732|BG000|Baseline|B/F/TAF|Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339504|NCT03631732|BG001|Baseline|Stay on Baseline Regimen/ Delayed B/F/TAF|Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339505|NCT03631732|BG002|Baseline|Total|Total of all reporting groups
11339506|NCT03631732|FG000|Participant Flow|B/F/TAF|Participants received bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed dose combination (FDC) tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339507|NCT03631732|FG001|Participant Flow|Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF|Participants stayed on baseline regimen consisting of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339508|NCT03631732|OG000|Outcome|B/F/TAF|Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
11339509|NCT03631732|OG001|Outcome|Stay on Baseline Regimen (SBR)|Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
11339510|NCT03631732|OG000|Outcome|B/F/TAF|Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11378186|NCT02666183|OG000|Outcome|Closer|"The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in real time during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers~Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support"
11378187|NCT02666183|OG001|Outcome|Video-C Only|"This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be delivered systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in real time during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers"
11378188|NCT02666183|OG002|Outcome|Web-Only|"This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association, etc.), b)Resources for DCGs (links to the Caregiving from a Distance, etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.~Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information"
11378189|NCT02666183|EG000|Reported Event|Closer|"The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in real time during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers~Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support"
11378190|NCT02666183|EG001|Reported Event|Video-C Only|"This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be delivered systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in real time during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.~Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers"
11378191|NCT02666183|EG002|Reported Event|Web-Only|"This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association, etc.), b)Resources for DCGs (links to the Caregiving from a Distance, etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.~Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information"
11378192|NCT01547117|BG000|Baseline|Healthy Participants-Low Na+ Then High Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
11378193|NCT01547117|BG001|Baseline|Healthy Participants-High Na+ Then Low Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
11378194|NCT01547117|BG002|Baseline|Patients With POTS-Low Na+ Then High Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
11192798|NCT02141295|BG000|Baseline|Safety Run-In|8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
11339511|NCT03631732|OG001|Outcome|Delayed B/F/TAF|Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11378195|NCT01547117|BG003|Baseline|Patients With POTS-High Na+ Then Low Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
11339512|NCT03631732|EG000|Reported Event|B/F/TAF up to Week 24|Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 24 weeks, without regard to food.
11339513|NCT03631732|EG001|Reported Event|SBR up to Week 24|Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
11339514|NCT03631732|EG002|Reported Event|B/F/TAF After Week 24|Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily from Week 24 to Week 48, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339515|NCT03631732|EG003|Reported Event|Delayed B/F/TAF|Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
11339516|NCT03631927|BG000|Baseline|Single Cohort|All patients > 15 years of age present in the intensive care unit on the study days
11339517|NCT03631927|FG000|Participant Flow|Patients|All patients present in the ICU on the study days were included in the study. Data were recorded for all patients present in the ICU during the 24 hours starting from 08.00 a.m. on the study day to 08.00 a.m. the next day. Neonatal and pediatric ICUs were not included. There were no other exclusion criteria.
11339518|NCT03631927|OG000|Outcome|Single Cohort|All patients > 15 years of age present in the intensive care unit on the study days
11339519|NCT03631927|EG000|Reported Event|Single Cohort|All patients > 15 years of age present in the intensive care unit on the study days
11339520|NCT03632083|BG000|Baseline|Overall Participants|"Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.~Contact Lens Solution: Hy-Care Contact Lens Solution Contact Lens Solution: Lite contact lens solution"
11339521|NCT03632083|FG000|Participant Flow|Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Right Eye|"Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339522|NCT03632083|FG001|Participant Flow|Hy-Care - Fanfilcon A Then Lite - Comilcon A on Left Eye|"Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339523|NCT03632083|FG002|Participant Flow|Hy-Care - Fanfilcon A Then Lite - Comfilcon A on Right Eye|"Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339524|NCT03632083|FG003|Participant Flow|Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Left Eye|"Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339525|NCT03632083|FG004|Participant Flow|Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Right Eye|"Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on right eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339526|NCT03632083|FG005|Participant Flow|Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Left Eye|"Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339527|NCT03632083|FG006|Participant Flow|Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Right Eye|"Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care solution on right eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
10800701|NCT01165424|EG000|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
11192799|NCT02141295|BG001|Baseline|Vanucizumab + mFOLFOX-6|In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11202164|NCT02205801|OG003|Outcome|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11378196|NCT01547117|BG004|Baseline|Total|Total of all reporting groups
11192800|NCT02141295|BG002|Baseline|Bevacizumab + mFOLFOX-6|In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11378197|NCT01547117|FG000|Participant Flow|Healthy Participants-Low Na+ Then High Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 milliequivalents (mEq) sodium/day, 12 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
11378198|NCT01547117|FG001|Participant Flow|Healthy Participants-High Na+ Then Low Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 5 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
11378199|NCT01547117|FG002|Participant Flow|Patients With POTS-Low Na+ Then High Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 10 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
11378200|NCT01547117|FG003|Participant Flow|Patients With POTS-High Na+ Then Low Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 11 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
11378201|NCT01547117|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
11378202|NCT01547117|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
11378203|NCT01547117|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.~Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
11378204|NCT01547117|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.~Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
11192801|NCT02141295|BG003|Baseline|Total|Total of all reporting groups
11378205|NCT01547117|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Upright plasma renin activity was measured in blood samples collected after up to 30 minutes of standing on the 7th day of low sodium diet."
11378206|NCT01547117|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Upright plasma renin activity was measured in blood samples collected after up to 30 minutes of standing on the 7th day of high sodium diet."
11378207|NCT01547117|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.~Upright plasma renin activity was measured in blood samples collected after up to 30 minutes of standing on the 7th day of low sodium diet."
11378208|NCT01547117|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.~Upright plasma renin activity was measured in blood samples collected after up to 30 minutes of standing on the 7th day of high sodium diet."
11378209|NCT01547117|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Upright serum aldosterone was measured in blood samples collected after up to 30 minutes of standing on the 7th day of low sodium diet."
11192802|NCT02141295|FG000|Participant Flow|Safety Run-In|8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
11202165|NCT02205801|EG000|Reported Event|Superficial Cervical Block, Active|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
10800702|NCT01135134|BG000|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
10800703|NCT01135134|BG001|Baseline|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
10800704|NCT01135134|BG002|Baseline|Total|Total of all reporting groups
10800705|NCT01135134|FG000|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
10800706|NCT01135134|FG001|Participant Flow|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
10800707|NCT01135134|OG000|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
10800708|NCT01135134|OG001|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
10800709|NCT01135134|EG000|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
10800710|NCT01135134|EG001|Reported Event|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
10800711|NCT00867165|BG000|Baseline|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
10800712|NCT00867165|BG001|Baseline|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
10800713|NCT00867165|BG002|Baseline|Total|Total of all reporting groups
10800714|NCT00867165|FG000|Participant Flow|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
10800715|NCT00867165|FG001|Participant Flow|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
10800716|NCT00867165|OG000|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
10800717|NCT00867165|OG001|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
10800718|NCT00867165|EG000|Reported Event|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
10800719|NCT00867165|EG001|Reported Event|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
10800720|NCT00733005|BG000|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800721|NCT00733005|BG001|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
10800722|NCT00733005|BG002|Baseline|Total|Total of all reporting groups
10800723|NCT00733005|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800724|NCT00733005|FG001|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
10800725|NCT00733005|OG000|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800726|NCT00733005|OG001|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
10800727|NCT00733005|EG000|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800728|NCT00733005|EG001|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
10800729|NCT00732381|BG000|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
11378210|NCT01547117|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Upright serum aldosterone was measured in blood samples collected after up to 30 minutes of standing on the 7th day of high sodium diet."
11378211|NCT01547117|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.~Upright serum aldosterone was measured in blood samples collected after up to 30 minutes of standing on the 7th day of low sodium diet."
11378212|NCT01547117|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.~Upright serum aldosterone was measured in blood samples collected after up to 30 minutes of standing on the 7th day of high sodium diet."
11378213|NCT01547117|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Supine and upright heart rate were measured on the 7th day of low sodium diet."
11378214|NCT01547117|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Supine and upright heart rate were measured on the 7th day of high sodium diet."
11378215|NCT01547117|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.~Supine and upright heart rate were measured on the 7th day of low sodium diet."
11378216|NCT01547117|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.~Supine and upright heart rate were measured on the 7th day of high sodium diet."
11378217|NCT01547117|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Upright symptoms were assessed on the 7th day of low sodium diet."
11378218|NCT01547117|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Upright symptoms were assessed on the 7th day of high sodium diet."
11378219|NCT01547117|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.~Upright symptoms were assessed on the 7th day of low sodium diet."
11378220|NCT01547117|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|"Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.~Upright symptoms were assessed on the 7th day of high sodium diet."
11378221|NCT01547117|EG000|Reported Event|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
11378222|NCT01547117|EG001|Reported Event|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
11378223|NCT01547117|EG002|Reported Event|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
11378224|NCT01547117|EG003|Reported Event|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
11378225|NCT01431508|BG000|Baseline|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
11378226|NCT01431508|FG000|Participant Flow|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
11378227|NCT01431508|OG000|Outcome|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
11378228|NCT01431508|EG000|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|
11378229|NCT00871351|BG000|Baseline|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378230|NCT00871351|BG001|Baseline|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378231|NCT00871351|BG002|Baseline|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378232|NCT00871351|BG003|Baseline|Total|Total of all reporting groups
11378233|NCT00871351|FG000|Participant Flow|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378234|NCT00871351|FG001|Participant Flow|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378235|NCT00871351|FG002|Participant Flow|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378236|NCT00871351|OG000|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378237|NCT00871351|OG001|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378238|NCT00871351|OG002|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378239|NCT00871351|EG000|Reported Event|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378240|NCT00871351|EG001|Reported Event|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378241|NCT00871351|EG002|Reported Event|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
11378242|NCT00832455|BG000|Baseline|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
11378243|NCT00832455|FG000|Participant Flow|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
11378244|NCT00832455|OG000|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
11378245|NCT00832455|OG001|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
11378246|NCT00832455|OG002|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
11378247|NCT00832455|OG000|Outcome|Montelukast ITT at Week 0|
11378248|NCT00832455|OG001|Outcome|Montelukast ITT at Week 4|
11378249|NCT00832455|OG002|Outcome|Montelukast ITT at Week 8|
11378250|NCT00832455|OG003|Outcome|Montelukast ITT at Week 12|
11378251|NCT00832455|OG000|Outcome|Montelukast ITT at Week 4|
11378252|NCT00832455|OG001|Outcome|Montelukast ITT at Week 8|
11378253|NCT00832455|OG002|Outcome|Montelukast ITT at Week 12|
11378254|NCT00832455|EG000|Reported Event|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
11378255|NCT00812006|BG000|Baseline|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
11378256|NCT00812006|BG001|Baseline|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
11378257|NCT00812006|BG002|Baseline|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
11378258|NCT00812006|BG003|Baseline|Total|Total of all reporting groups
10800730|NCT00732381|BG001|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
11378259|NCT00812006|FG000|Participant Flow|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
11378260|NCT00812006|FG001|Participant Flow|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
11378261|NCT00812006|FG002|Participant Flow|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
11378262|NCT00812006|OG000|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
11378263|NCT00812006|OG001|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
11378264|NCT00812006|EG000|Reported Event|Rizatriptan|"Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
11378265|NCT00812006|EG001|Reported Event|Placebo|"Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
11378266|NCT00739050|BG000|Baseline|All Participants|"All Randomized patients.~Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)"
11378267|NCT00739050|FG000|Participant Flow|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
11378268|NCT00739050|FG001|Participant Flow|Placebo|Placebo daily at nights for 12 weeks
11378269|NCT00739050|OG000|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
11378270|NCT00739050|OG001|Outcome|Placebo|Placebo daily at nights for 12 weeks
11378271|NCT00739050|EG000|Reported Event|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
11378272|NCT00739050|EG001|Reported Event|Placebo|Placebo daily at nights for 12 weeks
11378273|NCT00687531|BG000|Baseline|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
11378274|NCT00687531|FG000|Participant Flow|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
11378275|NCT00687531|OG000|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
11202166|NCT02205801|EG001|Reported Event|Superficial Cervical Block, Placebo|"After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.~Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
10800731|NCT00732381|BG002|Baseline|Total|Total of all reporting groups
10800732|NCT00732381|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800733|NCT00732381|FG001|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
10800734|NCT00732381|OG000|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10800735|NCT00732381|OG001|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
11378276|NCT00687531|EG000|Reported Event|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
11378277|NCT00654628|BG000|Baseline|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
11378278|NCT00654628|FG000|Participant Flow|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
11378279|NCT00654628|OG000|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
11378280|NCT00654628|EG000|Reported Event|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
11378281|NCT00604812|BG000|Baseline|Panel A|Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)
11378282|NCT00604812|BG001|Baseline|Panel B|Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)
11378283|NCT00604812|BG002|Baseline|Panel C|Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)
11378284|NCT00604812|BG003|Baseline|Total|Total of all reporting groups
11378285|NCT00604812|FG000|Participant Flow|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
11378286|NCT00604812|FG001|Participant Flow|Panel A Placebo|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
11378287|NCT00604812|FG002|Participant Flow|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
11378288|NCT00604812|FG003|Participant Flow|Panel B Placebo|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
11378289|NCT00604812|FG004|Participant Flow|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
11378290|NCT00604812|FG005|Participant Flow|Panel C Placebo|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
11378291|NCT00604812|OG000|Outcome|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
11378292|NCT00604812|OG001|Outcome|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
11378293|NCT00604812|OG002|Outcome|Placebo|Combined Placebo groups from panels A, B, and C.
11378294|NCT00604812|OG000|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
11378295|NCT00604812|OG001|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
11378296|NCT00604812|OG002|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
11378297|NCT00604812|EG000|Reported Event|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
11378298|NCT00604812|EG001|Reported Event|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
11378299|NCT00604812|EG002|Reported Event|Placebo|Combined Placebo groups from panels A, B, and C.
11378300|NCT00536380|BG000|Baseline|5-mg Desloratadine|5-mg Desloratadine once daily
11378301|NCT00536380|BG001|Baseline|10-mg Desloratadine|10-mg Desloratadine once daily
11378302|NCT00536380|BG002|Baseline|20-mg Desloratadine|20-mg Desloratadine once daily
11378303|NCT00536380|BG003|Baseline|Total|Total of all reporting groups
11378304|NCT00536380|FG000|Participant Flow|5-mg Desloratadine|5-mg Desloratadine once daily
11378305|NCT00536380|FG001|Participant Flow|10-mg Desloratadine|10-mg Desloratadine once daily
11378306|NCT00536380|FG002|Participant Flow|20-mg Desloratadine|20-mg Desloratadine once daily
11378307|NCT00536380|OG000|Outcome|5-mg Desloratadine|5-mg Desloratadine once daily
11378308|NCT00536380|OG001|Outcome|20-mg Desloratadine|20-mg Desloratadine once daily
11378309|NCT00536380|OG002|Outcome|10-mg Desloratadine|10-mg Desloratadine once daily
11378310|NCT00536380|EG000|Reported Event|5-mg Desloratadine|5-mg Desloratadine once daily
11378311|NCT00536380|EG001|Reported Event|10-mg Desloratadine|10-mg Desloratadine once daily
11378312|NCT00536380|EG002|Reported Event|20-mg Desloratadine|20-mg Desloratadine once daily
11378313|NCT00521599|BG000|Baseline|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
11378314|NCT00521599|BG001|Baseline|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
11378315|NCT00521599|BG002|Baseline|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
11378316|NCT00521599|BG003|Baseline|Total|Total of all reporting groups
11378317|NCT00521599|FG000|Participant Flow|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
11378318|NCT00521599|FG001|Participant Flow|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
11378319|NCT00521599|FG002|Participant Flow|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
11378320|NCT00521599|OG000|Outcome|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
11378321|NCT00521599|OG001|Outcome|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
11378322|NCT00521599|OG002|Outcome|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
11378323|NCT00521599|EG000|Reported Event|OL 1 X 200 mcg BID|Open-label MF DPI 200 mcg BID
11378324|NCT00521599|EG001|Reported Event|MF DPI 2 x 100 mcg BID|2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
11378325|NCT00521599|EG002|Reported Event|MF DPI 1 x 200 Mcg BID|1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
11378326|NCT00521599|EG003|Reported Event|Placebo|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
11378327|NCT00496834|BG000|Baseline|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
11378328|NCT00496834|BG001|Baseline|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
11378329|NCT00496834|BG002|Baseline|Total|Total of all reporting groups
11378330|NCT00496834|FG000|Participant Flow|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
11378331|NCT00496834|FG001|Participant Flow|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
11378332|NCT00496834|OG000|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
11378333|NCT00496834|OG001|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
11378334|NCT00496834|OG000|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.
11378335|NCT00496834|OG001|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation."
11378336|NCT00496834|EG000|Reported Event|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.
10800736|NCT00732381|EG000|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
11378337|NCT00496834|EG001|Reported Event|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once."
11378338|NCT00442897|BG000|Baseline|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
11378339|NCT00442897|BG001|Baseline|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
11378340|NCT00442897|BG002|Baseline|Total|Total of all reporting groups
11378341|NCT00442897|FG000|Participant Flow|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
11378342|NCT00442897|FG001|Participant Flow|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
11378343|NCT00442897|OG000|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
11378344|NCT00442897|OG001|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
11378345|NCT00442897|EG000|Reported Event|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
11378346|NCT00442897|EG001|Reported Event|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
11378347|NCT00423579|BG000|Baseline|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
11378348|NCT00423579|BG001|Baseline|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
11378349|NCT00423579|BG002|Baseline|Total|Total of all reporting groups
11378350|NCT00423579|FG000|Participant Flow|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
11378351|NCT00423579|FG001|Participant Flow|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
11378352|NCT00423579|OG000|Outcome|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
11378353|NCT00423579|OG001|Outcome|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
11378354|NCT00423579|EG000|Reported Event|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
11378355|NCT00423579|EG001|Reported Event|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
11378356|NCT00394355|BG000|Baseline|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
11378357|NCT00394355|BG001|Baseline|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
11378358|NCT00394355|BG002|Baseline|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
11378359|NCT00394355|BG003|Baseline|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
11378360|NCT00394355|BG004|Baseline|Total|Total of all reporting groups
11378361|NCT00394355|FG000|Participant Flow|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
11378362|NCT00394355|FG001|Participant Flow|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
11378363|NCT00394355|FG002|Participant Flow|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
10800737|NCT00732381|EG001|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
11378364|NCT00394355|FG003|Participant Flow|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
11378365|NCT00394355|OG000|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
11378366|NCT00394355|OG001|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
11378367|NCT00394355|OG002|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
11378368|NCT00394355|OG003|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
11378369|NCT00394355|EG000|Reported Event|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
11378370|NCT00394355|EG001|Reported Event|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
11378371|NCT00394355|EG002|Reported Event|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
11378372|NCT00394355|EG003|Reported Event|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
10964243|NCT00876460|BG004|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11378373|NCT00359216|BG000|Baseline|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
11378374|NCT00359216|BG001|Baseline|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
11378375|NCT00359216|BG002|Baseline|Total|Total of all reporting groups
11378376|NCT00359216|FG000|Participant Flow|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
11378377|NCT00359216|FG001|Participant Flow|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
11378378|NCT00359216|OG000|Outcome|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
11378379|NCT00359216|OG001|Outcome|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
11378380|NCT00359216|EG000|Reported Event|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
11378381|NCT00359216|EG001|Reported Event|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
11378382|NCT00166504|BG000|Baseline|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
11378383|NCT00166504|BG001|Baseline|Atorvastatin|Atorvastatin 10 mg
11378384|NCT00166504|BG002|Baseline|Total|Total of all reporting groups
11378385|NCT00166504|FG000|Participant Flow|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
11378386|NCT00166504|FG001|Participant Flow|Atorvastatin|Atorvastatin 10 mg
11378387|NCT00166504|OG000|Outcome|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
11378388|NCT00166504|OG001|Outcome|Atorvastatin|Atorvastatin 10 mg
11378389|NCT00166504|EG000|Reported Event|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
11378390|NCT00166504|EG001|Reported Event|Atorvastatin|Atorvastatin 10 mg
11202167|NCT02205801|EG002|Reported Event|Local Wound Infiltration, Active|"After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~Marcaine"
10800738|NCT00654095|BG000|Baseline|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
10800739|NCT00654095|FG000|Participant Flow|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
10800740|NCT00654095|OG000|Outcome|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
10800741|NCT00654095|EG000|Reported Event|Ezetimibe+Atorvastatin|
10800742|NCT00653523|BG000|Baseline|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
10800743|NCT00653523|FG000|Participant Flow|Ezetimibe + Simvastatin|"Ezetimibe 10 mg + Simvastatin 20 mg~level below what was specified in inclusion criterion~level >2x upper limit of normal at start of treatment~level >=3x upper limit of normal after start of treatment~did not resolve or improve after dose reduction of simvastatin"
10800744|NCT00653523|OG000|Outcome|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
10800745|NCT00653523|EG000|Reported Event|Ezetimibe+Simvastatin|
10800746|NCT00599027|BG000|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
10800747|NCT00599027|BG001|Baseline|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
10800748|NCT00599027|BG002|Baseline|Total|Total of all reporting groups
10800749|NCT00599027|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
10800750|NCT00599027|FG001|Participant Flow|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
10800751|NCT00599027|OG000|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
10800752|NCT00599027|OG001|Outcome|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
10800753|NCT00599027|EG000|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
10800754|NCT00599027|EG001|Reported Event|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
10800755|NCT00552032|BG000|Baseline|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800756|NCT00552032|BG001|Baseline|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800757|NCT00552032|BG002|Baseline|Total|Total of all reporting groups
10800758|NCT00552032|FG000|Participant Flow|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800759|NCT00552032|FG001|Participant Flow|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800760|NCT00552032|OG000|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800761|NCT00552032|OG001|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800762|NCT00552032|EG000|Reported Event|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800763|NCT00552032|EG001|Reported Event|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
10800764|NCT00546052|BG000|Baseline|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
11339528|NCT03632083|FG007|Participant Flow|Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Left Eye|"Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens"
11339529|NCT03632083|OG000|Outcome|Hy-Care Contact Lens Solution - Comfilcon A|"Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens"
11339530|NCT03632083|OG001|Outcome|Hy-Care Contact Lens Solution - Fanfilcon A|"Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution.~Contact Lens Solution: Hy-Care Contact Lens Solution~contact lens: fanfilcon A soft contact lens"
10800765|NCT00546052|FG000|Participant Flow|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
11339531|NCT03632083|OG002|Outcome|Lite Contact Lens Solution - Comfilcon A|"Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution.~Contact Lens Solution: Lite Contact Lens Solution~Contact lens: comfilcon A soft contact lens"
11339532|NCT03632083|OG003|Outcome|Lite Contact Lens Solution - Fanfilcon A|"Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution.~Contact Lens Solution: Lite contact Lens Solution~Contact lens: fanfilcon A soft contact lens"
11339533|NCT03632083|OG000|Outcome|Hy-Care Contact Lens Solution - Comfilcon A|"Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Hy-Care contact lens solution.~Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens"
11339534|NCT03632083|OG002|Outcome|Lite Contact Lens Solution - Comfilcon A|"Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution.~Contact Lens Solution: Lite Contact Lens Solution~Contact lens: comfilcon A soft contact lens"
11339535|NCT03632083|EG000|Reported Event|Hy-Care Contact Lens Solution - Comfilcon A|Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens
11339536|NCT03632083|EG001|Reported Event|Hy-Care Contact Lens Solution - Fanfilcon A|"Contact Lens Solution: Hy-Care Contact Lens Solution~contact lens: fanfilcon A soft contact lens"
11339537|NCT03632083|EG002|Reported Event|Lite Contact Lens Solution - Comfilcon A|"Contact Lens Solution: Lite Contact Lens Solution~Contact lens: comfilcon A soft contact lens"
11339538|NCT03632083|EG003|Reported Event|Lite Contact Lens Solution - Fanfilcon A|"Contact Lens Solution: Lite contact Lens Solution~Contact lens: fanfilcon A soft contact lens"
11339539|NCT03632109|BG000|Baseline|Single Arm|Pharyngeal Gonorrhea
11339540|NCT03632109|FG000|Participant Flow|Single Arm|Pharyngeal Gonorrhea
11339541|NCT03632109|OG000|Outcome|Pharyngeal Gonorrhea|Evaluable Population
11339542|NCT03632109|OG000|Outcome|Single Arm|"Men who have sex with men (MSM) with pharyngeal gonorrhea will be treated with 360mg intramuscular gentamicin x 1.~gentamicin 360mg IM: 360mg IM of gentamicin"
11339543|NCT03632109|OG000|Outcome|Single Arm|Pharyngeal gonorrhea
11339544|NCT03632109|EG000|Reported Event|Single Arm|"Men who have sex with men (MSM) with pharyngeal gonorrhea will be treated with 360mg intramuscular gentamicin x 1.~gentamicin 360mg IM: 360mg IM of gentamicin"
11339545|NCT03632954|BG000|Baseline|ACell Arm|"Cytal® Wound Matrix and/or MicroMatrix®~Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.~MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.~ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®"
11339546|NCT03632954|FG000|Participant Flow|ACell Arm|"Cytal® Wound Matrix and/or MicroMatrix®~Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.~MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.~ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®"
11339547|NCT03632954|OG000|Outcome|ACell Arm|"Cytal® Wound Matrix and/or MicroMatrix®~Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.~MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.~ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®"
11339548|NCT03632954|EG000|Reported Event|ACell Arm|"Cytal® Wound Matrix and/or MicroMatrix®~Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.~MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.~ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®"
11339549|NCT03633084|BG000|Baseline|RBM-007 Injectable Solution - 0.2 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339550|NCT03633084|BG001|Baseline|RBM-007 Injectable Solution - 1.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
10800766|NCT00546052|OG000|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
10800767|NCT00546052|OG000|Outcome|Overall Total|All patients enrolled (signed the informed consent).
10800768|NCT00546052|OG001|Outcome|Overall Intend to Treat|All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
10800769|NCT00546052|OG002|Outcome|Overall Per Protocol|All patients completing the 52 week study follow up.
10800770|NCT00546052|EG000|Reported Event|Overall ITT|
10800771|NCT00442117|BG000|Baseline|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
10800772|NCT00442117|BG001|Baseline|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
10800773|NCT00442117|BG002|Baseline|Total|Total of all reporting groups
10800774|NCT00442117|FG000|Participant Flow|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
10800775|NCT00442117|FG001|Participant Flow|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
10800776|NCT00442117|OG000|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
11192803|NCT02141295|FG001|Participant Flow|Vanucizumab + mFOLFOX-6|In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
10800777|NCT00442117|OG001|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
10800778|NCT00442117|EG000|Reported Event|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
10800779|NCT00442117|EG001|Reported Event|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
10800780|NCT00424008|BG000|Baseline|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
10800781|NCT00424008|BG001|Baseline|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
10800782|NCT00424008|BG002|Baseline|Total|Total of all reporting groups
10800783|NCT00424008|FG000|Participant Flow|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
10800784|NCT00424008|FG001|Participant Flow|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
10800785|NCT00424008|OG000|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
10800786|NCT00424008|OG001|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
10800787|NCT00424008|EG000|Reported Event|Open-label (OL) MF MDI * 200 MCG BID|Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI).
10800788|NCT00424008|EG001|Reported Event|MF/F MDI * 200/10 MCG * BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
10800789|NCT00424008|EG002|Reported Event|F/SC DPI * 250/50 MCG BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
10800790|NCT00423176|BG000|Baseline|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
10800791|NCT00423176|BG001|Baseline|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
10800792|NCT00423176|BG002|Baseline|Total|Total of all reporting groups
11202168|NCT02205801|EG003|Reported Event|Local Wound Infiltration, Placebo|"After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.~Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.~0.9% saline"
11202169|NCT02205814|BG000|Baseline|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
11339551|NCT03633084|BG002|Baseline|RBM-007 Injectable Solution - 2.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
10800793|NCT00423176|FG000|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
11339552|NCT03633084|BG003|Baseline|Total|Total of all reporting groups
11339553|NCT03633084|FG000|Participant Flow|RBM-007 Injectable Solution - 0.2 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339554|NCT03633084|FG001|Participant Flow|RBM-007 Injectable Solution - 1.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11378391|NCT01345240|BG000|Baseline|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378392|NCT01345240|BG001|Baseline|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378393|NCT01345240|BG002|Baseline|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378394|NCT01345240|BG003|Baseline|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378395|NCT01345240|BG004|Baseline|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378396|NCT01345240|BG005|Baseline|Total|Total of all reporting groups
11378397|NCT01345240|FG000|Participant Flow|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378398|NCT01345240|FG001|Participant Flow|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
10800794|NCT00423176|FG001|Participant Flow|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
11192804|NCT02141295|FG002|Participant Flow|Bevacizumab + mFOLFOX-6|In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11192805|NCT02141295|OG000|Outcome|Vanucizumab + mFOLFOX-6|In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11192806|NCT02141295|OG001|Outcome|Bevacizumab + mFOLFOX-6|In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11339555|NCT03633084|FG002|Participant Flow|RBM-007 Injectable Solution - 2.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339556|NCT03633084|OG000|Outcome|RBM-007 Injectable Solution - 0.2 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339557|NCT03633084|OG001|Outcome|RBM-007 Injectable Solution - 1.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339558|NCT03633084|OG002|Outcome|RBM-007 Injectable Solution - 2.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339559|NCT03633084|OG002|Outcome|RBM-007 Injectable Solution - 2 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339560|NCT03633084|EG000|Reported Event|RBM-007 Injectable Solution - 0.2 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339561|NCT03633084|EG001|Reported Event|RBM-007 Injectable Solution - 1.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339562|NCT03633084|EG002|Reported Event|RBM-007 Injectable Solution - 2.0 mg|"No additional information.~RBM-007 Injectable Solution: (No additional description)"
11339563|NCT03633331|BG000|Baseline|Treatment (Palbociclib, Letrozole or Fulvestrant)|"Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>~> Quality-of-Life Assessment: Ancillary studies"
11339564|NCT03633331|FG000|Participant Flow|Treatment (Palbociclib, Letrozole or Fulvestrant)|"Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>~> Quality-of-Life Assessment: Ancillary studies"
11339565|NCT03633331|OG000|Outcome|Treatment (Palbociclib, Letrozole or Fulvestrant)|"Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>~> Quality-of-Life Assessment: Ancillary studies"
11339566|NCT03633331|EG000|Reported Event|Treatment (Palbociclib, Letrozole or Fulvestrant)|Quality-of-Life Assessment: Ancillary studies
11339567|NCT03633344|BG000|Baseline|Carbowhite|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite"
11339568|NCT03633344|BG001|Baseline|Carbowhite Placebo|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite placebo"
11339569|NCT03633344|BG002|Baseline|Total|Total of all reporting groups
11339570|NCT03633344|FG000|Participant Flow|Carbowhite|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite"
11339571|NCT03633344|FG001|Participant Flow|Carbowhite Placebo|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite placebo"
11339572|NCT03633344|OG000|Outcome|Carbowhite|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite"
11192807|NCT02141295|OG000|Outcome|Safety Run-In|8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
10964244|NCT00876460|BG005|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964245|NCT00876460|BG006|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11202170|NCT02205814|BG001|Baseline|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
11339573|NCT03633344|OG001|Outcome|Carbowhite Placebo|3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
10964246|NCT00876460|BG007|Baseline|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964247|NCT00876460|BG008|Baseline|Total|Total of all reporting groups
10964248|NCT00876460|FG000|Participant Flow|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11202171|NCT02205814|BG002|Baseline|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
11202172|NCT02205814|BG003|Baseline|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
11202173|NCT02205814|BG004|Baseline|Total|Total of all reporting groups
11339574|NCT03633344|OG001|Outcome|Carbowhite Placebo|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite placebo"
11339575|NCT03633344|OG001|Outcome|Carbowhite Placebo|3 tablets as a single dose (210mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg);
11339576|NCT03633344|EG000|Reported Event|Carbowhite|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite"
11339577|NCT03633344|EG001|Reported Event|Carbowhite Placebo|"3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)~Carbowhite placebo"
11339578|NCT03633448|BG000|Baseline|Adolescent|"Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~There was a 7 days washout period between each administration."
11339579|NCT03633448|BG001|Baseline|Adult|"Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~There was a 7 days washout period between each administration."
11339580|NCT03633448|BG002|Baseline|Total|Total of all reporting groups
11339581|NCT03633448|FG000|Participant Flow|200mg Dose of Guaifenesin, Then 400mg Dose of Guaifenesin|"Treatment Sequences 1 [6 adolescents/6 adults]: Treatment A in Period 1, then Treatment B in Period 2~Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~There was a 7 days washout period between each administration."
11339582|NCT03633448|FG001|Participant Flow|400mg Dose of Guaifenesin, Then 200mg Dose of Guaifenesin|"Treatment Sequences 2 [6 adolescents/6 adults]: Treatment B in Period 1, then Treatment A in Period 2.~Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.~There was a 7 days washout period between each administration."
11339583|NCT03633448|OG000|Outcome|Treatment A (Adolescents)|Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339584|NCT03633448|OG001|Outcome|Treatment A (Adults)|Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339585|NCT03633448|OG002|Outcome|Treatment B (Adolescents)|Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339586|NCT03633448|OG003|Outcome|Treatment B (Adults)|Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339587|NCT03633448|EG000|Reported Event|Treatment A (Adolescents)|Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339588|NCT03633448|EG001|Reported Event|Treatment A (Adults)|Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339589|NCT03633448|EG002|Reported Event|Treatment B (Adolescents)|Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339590|NCT03633448|EG003|Reported Event|Treatment B (Adults)|Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
11339591|NCT03633487|BG000|Baseline|Mucinex® 1200 mg|Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
11339592|NCT03633487|FG000|Participant Flow|Mucinex® 1200 mg|Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
11339593|NCT03633487|OG000|Outcome|Mucinex® 1200 mg|Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
11339594|NCT03633487|EG000|Reported Event|Mucinex® 1200 mg|Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
11339595|NCT03633526|BG000|Baseline|VX-659/TEZ/IVA|Participants who received VX-659 120 mg/TEZ 50 mg/ IVA 75 mg as FDC in the morning and IVA 75 mg as a mono tablet in the evening for 15 days in the TC treatment period.
11339596|NCT03633526|FG000|Participant Flow|VX-659/TEZ/IVA|Participants who received VX-659 120 mg/TEZ 50 mg/ IVA 75 mg as FDC in the morning and IVA 75 mg as a mono tablet in the evening for 15 days in the TC treatment period.
11339597|NCT03633526|OG000|Outcome|VX-659/TEZ/IVA|Participants who received VX-659 120 mg/TEZ 50 mg/ IVA 75 mg as FDC in the morning and IVA 75 mg as a mono tablet in the evening for 15 days in the TC treatment period.
10964249|NCT00876460|FG001|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964250|NCT00876460|FG002|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964251|NCT00876460|FG003|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964252|NCT00876460|FG004|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11202174|NCT02205814|FG000|Participant Flow|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
10964253|NCT00876460|FG005|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964254|NCT00876460|FG006|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11378399|NCT01345240|FG002|Participant Flow|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378400|NCT01345240|FG003|Participant Flow|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378401|NCT01345240|FG004|Participant Flow|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378402|NCT01345240|OG000|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378403|NCT01345240|OG001|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups who were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378404|NCT01345240|OG000|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
10964255|NCT00876460|FG007|Participant Flow|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192808|NCT02141295|OG001|Outcome|Vanucizumab + mFOLFOX-6|In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11192809|NCT02141295|OG002|Outcome|Bevacizumab + mFOLFOX-6|In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
10800795|NCT00423176|OG000|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
11378405|NCT01345240|OG001|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378406|NCT01345240|OG002|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378407|NCT01345240|OG003|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378408|NCT01345240|OG004|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378409|NCT01345240|OG000|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378410|NCT01345240|OG001|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378411|NCT01345240|OG002|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378412|NCT01345240|OG001|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378413|NCT01345240|OG001|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378414|NCT01345240|OG000|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378415|NCT01345240|OG001|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378416|NCT01345240|EG000|Reported Event|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378417|NCT01345240|EG001|Reported Event|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378418|NCT01345240|EG002|Reported Event|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378419|NCT01345240|EG003|Reported Event|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
10964256|NCT00876460|OG000|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10800796|NCT00423176|OG001|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
11202175|NCT02205814|FG001|Participant Flow|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
11202176|NCT02205814|FG002|Participant Flow|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
11378420|NCT01345240|EG004|Reported Event|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
11378421|NCT01371305|BG000|Baseline|BG00011 0.015 mg|Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
11378422|NCT01371305|BG001|Baseline|BG00011 0.1 mg|Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
11378423|NCT01371305|BG002|Baseline|BG00011 0.3 mg|Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
11378424|NCT01371305|BG003|Baseline|BG00011 1.0 mg|Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
11378425|NCT01371305|BG004|Baseline|BG00011 3.0 mg|Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
11378426|NCT01371305|BG005|Baseline|Matching Placebo|Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
11378427|NCT01371305|BG006|Baseline|Total|Total of all reporting groups
11378428|NCT01371305|FG000|Participant Flow|BG00011 0.015 mg|Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
11378429|NCT01371305|FG001|Participant Flow|BG00011 0.1 mg|Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
11378430|NCT01371305|FG002|Participant Flow|BG00011 0.3 mg|Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
10964257|NCT00876460|OG001|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192810|NCT02141295|EG000|Reported Event|Safety Run-In|8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
11202177|NCT02205814|FG003|Participant Flow|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
11378431|NCT01371305|FG003|Participant Flow|BG00011 1.0 mg|Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
11378432|NCT01371305|FG004|Participant Flow|BG00011 3.0 mg|Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
11378433|NCT01371305|FG005|Participant Flow|Matching Placebo|Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
11378434|NCT01371305|OG000|Outcome|BG00011 0.015 mg|Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
11378435|NCT01371305|OG001|Outcome|BG00011 0.1 mg|Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
11378436|NCT01371305|OG002|Outcome|BG00011 0.3 mg|Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
11378437|NCT01371305|OG003|Outcome|BG00011 1.0 mg|Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
11378438|NCT01371305|OG004|Outcome|BG00011 3.0 mg|Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
11378439|NCT01371305|OG005|Outcome|Matching Placebo|Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
11378440|NCT01371305|OG005|Outcome|Matching Placebo|Participants with IPF received matching placebo.
11378441|NCT01371305|EG000|Reported Event|BG00011 0.015 mg|Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
11378442|NCT01371305|EG001|Reported Event|BG00011 0.1 mg|Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
11378443|NCT01371305|EG002|Reported Event|BG00011 0.3 mg|Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
11378444|NCT01371305|EG003|Reported Event|BG00011 1.0 mg|Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
11378445|NCT01371305|EG004|Reported Event|BG00011 3.0 mg|Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
11378446|NCT01371305|EG005|Reported Event|Matching Placebo|Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
11378447|NCT01376323|BG000|Baseline|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
11378448|NCT01376323|BG001|Baseline|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378449|NCT01376323|BG002|Baseline|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378450|NCT01376323|BG003|Baseline|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378451|NCT01376323|BG004|Baseline|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378452|NCT01376323|BG005|Baseline|Total|Total of all reporting groups
11378453|NCT01376323|FG000|Participant Flow|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules twice a day (BID) and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
11378454|NCT01376323|FG001|Participant Flow|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 milligrams (mg) capsules BID orally as directed with water for 12 weeks in a fed state.
10800797|NCT00423176|EG000|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
11202178|NCT02205814|OG000|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
11192811|NCT02141295|EG001|Reported Event|Vanucizumab + mFOLFOX-6|In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11192812|NCT02141295|EG002|Reported Event|Bevacizumab + mFOLFOX-6|In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m^2 as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m^2 as IV infusion; and 5-FU at a dose of 400 mg/m^2 as starting IV bolus followed by 2400 mg/m^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
11378455|NCT01376323|FG002|Participant Flow|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378456|NCT01376323|FG003|Participant Flow|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378457|NCT01376323|FG004|Participant Flow|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378458|NCT01376323|OG000|Outcome|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
11378459|NCT01376323|OG001|Outcome|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378460|NCT01376323|OG002|Outcome|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378461|NCT01376323|OG003|Outcome|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378462|NCT01376323|OG004|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378463|NCT01376323|OG001|Outcome|GSK256073 5mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378464|NCT01376323|OG002|Outcome|GSK256073 10mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378465|NCT01376323|OG003|Outcome|GSK256073 25mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378466|NCT01376323|OG004|Outcome|GSK256073 50mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378467|NCT01376323|OG004|Outcome|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378468|NCT01376323|OG001|Outcome|GSK256073 5 mg Bid|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378469|NCT01376323|OG002|Outcome|GSK256073 10 mg qd|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378470|NCT01376323|OG003|Outcome|GSK256073 25 mg Bid|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378471|NCT01376323|OG004|Outcome|GSK256073 50 mg qd|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378472|NCT01376323|OG004|Outcome|GSK256073 50 mg qd|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
10964258|NCT00876460|OG002|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964259|NCT00876460|OG003|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192813|NCT02141360|BG000|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192814|NCT02141360|BG001|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192815|NCT02141360|BG002|Baseline|Total|Total of all reporting groups
11339598|NCT03633526|EG000|Reported Event|VX-659/TEZ/IVA|Participants who received VX-659 120 mg/TEZ 50 mg/ IVA 75 mg as FDC in the morning and IVA 75 mg as a mono tablet in the evening for 15 days in the TC treatment period.
11339599|NCT03633825|BG000|Baseline|Control|Control Condition: Users in the control condition experienced the Koko digital platform as usual.
11339600|NCT03633825|BG001|Baseline|Intervention|Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
11339601|NCT03633825|BG002|Baseline|Total|Total of all reporting groups
11339602|NCT03633825|FG000|Participant Flow|Control|Control Condition: Users in the control condition experienced the Koko digital platform as usual.
11339603|NCT03633825|FG001|Participant Flow|Intervention|Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a previous study among Koko users found that a common concern was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
11339604|NCT03633825|OG000|Outcome|Control|Control Condition: Users in the control condition experienced the Koko digital platform as usual.
11339605|NCT03633825|OG001|Outcome|Intervention|Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
11339606|NCT03633825|EG000|Reported Event|Control|Control Condition: Users in the control condition experienced the Koko digital platform as usual.
11339607|NCT03633825|EG001|Reported Event|Intervention|Brief help-seeking barrier reduction intervention: The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
11339608|NCT03633903|BG000|Baseline|Mindfulness|"Mindfulness: Eight sessions, twice per week over four weeks~Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience"
11339609|NCT03633903|BG001|Baseline|Control|Treatment as usual, inactive control group
11339610|NCT03633903|BG002|Baseline|Total|Total of all reporting groups
11339611|NCT03633903|FG000|Participant Flow|Mindfulness|"Mindfulness: Eight sessions, twice per week over four weeks~Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience"
11339612|NCT03633903|FG001|Participant Flow|Control|Treatment as usual, inactive control group
11339613|NCT03633903|OG000|Outcome|Mindfulness|"Mindfulness: Eight sessions, twice per week over four weeks~Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience"
11339614|NCT03633903|OG001|Outcome|Control|Treatment as usual, inactive control group
11339615|NCT03633903|EG000|Reported Event|Mindfulness|"Mindfulness: Eight sessions, twice per week over four weeks~Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience"
11339616|NCT03633903|EG001|Reported Event|Control|Treatment as usual, inactive control group
11339617|NCT03633929|BG000|Baseline|Beta Test|All study participants used KIOS in a beta test to demonstrate feasibility of the software.
11339618|NCT03633929|FG000|Participant Flow|KIOS OUD|KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
11339619|NCT03633929|OG000|Outcome|KIOS OUD|KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
11339620|NCT03633929|EG000|Reported Event|KIOS OUD|KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
11192816|NCT02141360|FG000|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192817|NCT02141360|FG001|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192818|NCT02141360|FG002|Participant Flow|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
10800798|NCT00423176|EG001|Reported Event|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
10800799|NCT00383240|BG000|Baseline|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
10800800|NCT00383240|BG001|Baseline|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
11378473|NCT01376323|EG000|Reported Event|Placebo (Pooled)|Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
11378474|NCT01376323|EG001|Reported Event|GSK256073 5 mg BID|Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378475|NCT01376323|EG002|Reported Event|GSK256073 10 mg Once Daily|Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11378476|NCT01376323|EG003|Reported Event|GSK256073 25 mg BID|Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
11378477|NCT01376323|EG004|Reported Event|GSK256073 50 mg Once Daily|Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
11202179|NCT02205814|OG001|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
10800801|NCT00383240|BG002|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
10800802|NCT00383240|BG003|Baseline|Placebo BID|Placebo MDI BID for 26 weeks
10800803|NCT00383240|BG004|Baseline|Total|Total of all reporting groups
11202180|NCT02205814|OG002|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
11202181|NCT02205814|OG003|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
11202182|NCT02205814|EG000|Reported Event|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
11202183|NCT02205814|EG001|Reported Event|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
11202184|NCT02205814|EG002|Reported Event|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
11378478|NCT01386658|BG000|Baseline|Prepubertal|Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
10800804|NCT00383240|FG000|Participant Flow|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
10800805|NCT00383240|FG001|Participant Flow|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
10800806|NCT00383240|FG002|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
10800807|NCT00383240|FG003|Participant Flow|Placebo BID|Placebo MDI BID for 26 weeks
10800808|NCT00383240|OG000|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
10800809|NCT00383240|OG001|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
10800810|NCT00383240|OG002|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
10800811|NCT00383240|OG003|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
10800812|NCT00383240|EG000|Reported Event|OL MF MDI 200 MCG BID|Participants received 2 to 3 weeks (approximately) of open-label (OL), run-in medication with MF MDI 200 mcg BID prior to the 26-week double-blind treatment period.
10800813|NCT00383240|EG001|Reported Event|MF/F MDI 200/10 MCG BID|
10800814|NCT00383240|EG002|Reported Event|MF MDI 200 MCG BID|
10800815|NCT00383240|EG003|Reported Event|F MDI 10 MCG BID|
10800816|NCT00383240|EG004|Reported Event|PLACEBO|
10803649|NCT02878603|EG000|Reported Event|Standard of Care (SoC) (Treated in Study C301)|Participants who completed study ALX0681-C301 with SoC (plasma exchange [PE], corticosteroid and other immunosuppressive agents) treatment were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product [IMP], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg intravenous (IV) dose followed by a daily 10 milligrams (mg) subcutaneous (SC) injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10964260|NCT00876460|OG004|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11202185|NCT02205814|EG003|Reported Event|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
11378479|NCT01386658|BG001|Baseline|Pubertal/Postpubertal|Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
11378480|NCT01386658|BG002|Baseline|Total|Total of all reporting groups
11378481|NCT01386658|FG000|Participant Flow|Prepubertal|Participants received a single subcutaneous (SC) injection of 0.4 milligram per kilogram (mg/kg) icatibant (up to a maximal dose of 30 mg) in the abdominal region.
11378482|NCT01386658|FG001|Participant Flow|Pubertal/Postpubertal|Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
11378483|NCT01386658|OG000|Outcome|Prepubertal|Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
11378484|NCT01386658|OG001|Outcome|Pubertal/Postpubertal: With Acute Attack|Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
11378485|NCT01386658|OG002|Outcome|Pubertal/Postpubertal: Without Acute Attack|Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
11378486|NCT01386658|OG001|Outcome|Pubertal/Postpubertal|Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
11378487|NCT01386658|OG000|Outcome|Pubertal/Postpubertal|Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
10964261|NCT00876460|OG005|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964262|NCT00876460|OG006|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964263|NCT00876460|OG007|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11378488|NCT01386658|EG000|Reported Event|Prepubertal|Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
11378489|NCT01386658|EG001|Reported Event|Pubertal/Post-pubertal|Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
11378490|NCT01386658|EG002|Reported Event|Overall|Participants received a single subcutaneous(SC) injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. Pubertal/postpubertal participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
11378491|NCT01386684|BG000|Baseline|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
11378492|NCT01386684|FG000|Participant Flow|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
11378493|NCT01386684|OG000|Outcome|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
11378494|NCT01386684|EG000|Reported Event|Patients With Prostate Cancer|Patients with prostate cancer who were receiving treatment with Lupron.
11378495|NCT01386879|BG000|Baseline|TaperGuard Evac ETT|"Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378496|NCT01386879|BG001|Baseline|Teleflex ISIS ETT|"Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378497|NCT01386879|BG002|Baseline|Standard ETT|"Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378498|NCT01386879|BG003|Baseline|Total|Total of all reporting groups
11378499|NCT01386879|FG000|Participant Flow|TaperGuard Evac ETT|"Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378500|NCT01386879|FG001|Participant Flow|Teleflex ISIS ETT|"Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378501|NCT01386879|FG002|Participant Flow|Standard ETT|"Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378502|NCT01386879|OG000|Outcome|TaperGuard Evac ETT|"Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378503|NCT01386879|OG001|Outcome|Teleflex ISIS ETT|"Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11192819|NCT02141360|OG000|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192820|NCT02141360|OG001|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11192821|NCT02141360|OG002|Outcome|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11202186|NCT02205983|BG000|Baseline|2 mg Hydromophone|Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.
11339647|NCT03634306|EG000|Reported Event|ARM 1|"Laparoscopic hysterectomy with use of the Ultravision System~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
10964264|NCT00876460|OG001|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11339648|NCT03634306|EG001|Reported Event|ARM 2|"Laparoscopic Hysterectomy per Standard of Care/no Ultravision System~Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System"
11339649|NCT03634306|EG002|Reported Event|ARM 3|"Laparoscopic myomectomy with use of the Ultravision System.~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339650|NCT03634579|BG000|Baseline|MRI-guided Focal Laser Ablation|Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
11339651|NCT03634579|FG000|Participant Flow|MRI-guided Focal Laser Ablation|Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
10800817|NCT02797067|BG000|Baseline|Indomethacin|"Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.~indomethacin suppository: 100mg rectal indomethacin 30min before ESWL"
11339652|NCT03634579|OG000|Outcome|MRI-guided Focal Laser Ablation|Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
11192822|NCT02141360|EG000|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11378504|NCT01386879|OG002|Outcome|Standard ETT|"Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378505|NCT01386879|EG000|Reported Event|TaperGuard Evac ETT|"Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378506|NCT01386879|EG001|Reported Event|Teleflex ISIS ETT|"Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11378507|NCT01386879|EG002|Reported Event|Standard ETT|"Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)~methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated."
11192823|NCT02141360|EG001|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
10800818|NCT02797067|BG001|Baseline|Glycerin|"Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.~Glycerin Suppository: 30min before ESWL"
10800819|NCT02797067|BG002|Baseline|Total|Total of all reporting groups
11192824|NCT02141360|EG002|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
10800820|NCT02797067|FG000|Participant Flow|Indomethacin|"Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.~indomethacin suppository: 100mg rectal indomethacin 30min before ESWL"
10800821|NCT02797067|FG001|Participant Flow|Glycerin|"Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.~Glycerin Suppository: 30min before ESWL"
10800822|NCT02797067|OG000|Outcome|Indomethacin|"Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.~indomethacin suppository: 100mg rectal indomethacin 30min before ESWL"
10800823|NCT02797067|OG001|Outcome|Glycerin|"Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.~Glycerin Suppository: 30min before ESWL"
10800824|NCT02797067|EG000|Reported Event|Indomethacin|"Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.~indomethacin suppository: 100mg rectal indomethacin 30min before ESWL"
10800825|NCT02797067|EG001|Reported Event|Glycerin|"Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.~Glycerin Suppository: 30min before ESWL"
10803650|NCT02878603|EG001|Reported Event|Caplacizumab (Treated in Study C301)|Participants who completed study ALX0681-C301 and received caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to IMP, withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg IV dose followed by a daily 10 mg SC injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.
10803651|NCT02864407|BG000|Baseline|Vahelva® Respimat® (Tiotropium + Olodaterol Fixed Dose Combination)|Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination) was prescribed according to the local label and at the discretion of the treating physician. The recommended dose for adults is 5 microgram Tiotropium and 5 microgram Olodaterol given as two puffs from the Respimat® inhaler once daily at the same time of the day. Each puff contains 2.5 microgram Tiotropium and 2.5 microgram Olodaterol.
11192825|NCT02141399|BG000|Baseline|ALKS 5461|ALKS 5461 adjunctive treatment
11192826|NCT02141399|FG000|Participant Flow|ALKS 5461|ALKS 5461 adjunctive treatment
11378508|NCT04980014|BG000|Baseline|NesinaAct® Tablet|Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
11378509|NCT04980014|FG000|Participant Flow|NesinaAct® Tablet|Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
11378510|NCT04980014|OG000|Outcome|NesinaAct® Tablet|Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
11378511|NCT04980014|EG000|Reported Event|NesinaAct® Tablet|Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study.
11378512|NCT04503603|BG000|Baseline|Lanadelumab 300 mg|Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.
11378513|NCT04503603|BG001|Baseline|Placebo|Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.
11378514|NCT04503603|BG002|Baseline|Total|Total of all reporting groups
11378515|NCT04503603|FG000|Participant Flow|Lanadelumab 300 mg|Participants received a single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by a second dose on Day 4.
11378516|NCT04503603|FG001|Participant Flow|Placebo|Participants received a single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.
11378517|NCT04503603|OG000|Outcome|Lanadelumab 300 mg|Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.
11378518|NCT04503603|OG001|Outcome|Placebo|Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.
11378519|NCT04503603|EG000|Reported Event|Lanadelumab 300 mg|Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.
11378520|NCT04503603|EG001|Reported Event|Placebo|Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.
11378521|NCT04454918|BG000|Baseline|TAK-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1, followed by [14C]-TAK-906 100 μg (approximately 1 μCi), IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
11378522|NCT04454918|FG000|Participant Flow|TAK-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1, followed by [14C]-TAK-906 100 micrograms (μg) [approximately 1 microcurie (μCi)], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
11378523|NCT04454918|OG000|Outcome|TAK-906 50 mg + [14C]-TAK-906 100 μg|TAK-906 50 mg, capsule, orally, once on Day 1, followed by [14C]-TAK-906 100 μg [approximately 1 μCi], IV infusion, once on Day 1 of Treatment Period 1.
11378524|NCT04454918|OG000|Outcome|[14C]-TAK-906 50 mg|[14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
11378525|NCT04454918|OG000|Outcome|TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 of Treatment Period 1.
11378526|NCT04454918|OG000|Outcome|[14C]-TAK-906 100 μg|[14C]-TAK-906 100 μg (approximately 1 μCi), IV infusion, once on Day 1 of Treatment Period 1, after the TAK-906 oral dose, followed by a Washout Period of 7 days.
11378527|NCT04454918|EG000|Reported Event|TAK-906 50 mg + [14C]-TAK-906 100 μg|TAK-906 50 mg, capsule, orally, followed by [14C]-TAK-906 100 μg (approximately 1 μCi), infusion, intravenously, once on Day 1 of Treatment Period 1.
11378528|NCT04454918|EG001|Reported Event|[14C]-TAK-906 50 mg|[14C]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
11378529|NCT04427501|BG000|Baseline|Phase 2: Placebo|Participants received Placebo administered intravenously (IV).
11378530|NCT04427501|BG001|Baseline|Phase 2: 700 mg Bamlanivimab|Participants received 700 mg bamlanivimab administered IV.
10964265|NCT00876460|OG002|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11378531|NCT04427501|BG002|Baseline|Phase 2: 2800 mg Bamlanivimab|Participants received 2800 mg bamlanivimab administered IV.
11378532|NCT04427501|BG003|Baseline|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab administered IV.
11378533|NCT04427501|BG004|Baseline|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378534|NCT04427501|BG005|Baseline|Phase 3: Placebo|Participants received Placebo administered intravenously (IV).
11378535|NCT04427501|BG006|Baseline|Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378536|NCT04427501|BG007|Baseline|Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab|Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
11378537|NCT04427501|BG008|Baseline|Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378538|NCT04427501|BG009|Baseline|Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
11378539|NCT04427501|BG010|Baseline|Total|Total of all reporting groups
11378540|NCT04427501|FG000|Participant Flow|Phase 2: Placebo|Participants received Placebo administered intravenously (IV).
11378541|NCT04427501|FG001|Participant Flow|Phase 2: 700 mg Bamlanivimab|Participants received 700 milligram (mg) bamlanivimab administered IV.
11378542|NCT04427501|FG002|Participant Flow|Phase 2: 2800 mg Bamlanivimab|Participants received 2800 mg bamlanivimab administered IV.
11378543|NCT04427501|FG003|Participant Flow|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab administered IV.
11378544|NCT04427501|FG004|Participant Flow|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11192827|NCT02141399|OG000|Outcome|ALKS 5461|ALKS 5461 adjunctive treatment
11378545|NCT04427501|FG005|Participant Flow|Phase 3: Placebo|Participants received Placebo administered intravenously (IV).
11378546|NCT04427501|FG006|Participant Flow|Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378547|NCT04427501|FG007|Participant Flow|Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab|Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
11378548|NCT04427501|FG008|Participant Flow|Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378549|NCT04427501|FG009|Participant Flow|Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
11378550|NCT04427501|OG000|Outcome|Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378551|NCT04427501|OG001|Outcome|Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378552|NCT04427501|OG002|Outcome|Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378553|NCT04427501|OG003|Outcome|Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab|Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
11378554|NCT04427501|OG000|Outcome|Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378555|NCT04427501|OG001|Outcome|Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
11378556|NCT04427501|OG000|Outcome|Part A: Placebo|Participants received Placebo administered intravenously (IV).
11378557|NCT04427501|OG001|Outcome|Phase 2: 700 mg Bamlanivimab|Participants received 700 mg bamlanivimab administered IV.
11378558|NCT04427501|OG002|Outcome|Phase 2: 2800 mg Bamlanivimab|Participants received 2800 mg bamlanivimab administered IV.
11378559|NCT04427501|OG003|Outcome|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab administered IV.
11378560|NCT04427501|OG004|Outcome|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378561|NCT04427501|OG000|Outcome|Phase 2: Placebo|Participants received Placebo administered intravenously (IV).
11378562|NCT04427501|OG004|Outcome|Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378563|NCT04427501|OG005|Outcome|Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
11378564|NCT04427501|OG004|Outcome|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV..
11378565|NCT04427501|OG000|Outcome|Phase 2: 700 mg Bamlanivimab|Participants received 700 mg bamlanivimab (alone) administered IV.
11378566|NCT04427501|OG001|Outcome|Phase 2: 2800 mg Bamlanivimab|Participants received 2800 mg bamlanivimab (alone) administered IV.
11378567|NCT04427501|OG002|Outcome|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab (alone) administered IV..
11378568|NCT04427501|OG003|Outcome|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378569|NCT04427501|OG000|Outcome|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
10964266|NCT00876460|OG003|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964267|NCT00876460|OG004|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964268|NCT00876460|OG000|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
10964269|NCT00876460|OG001|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
10964270|NCT00876460|OG002|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
10964271|NCT00876460|OG000|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
10964272|NCT00876460|OG001|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
11378570|NCT04427501|OG003|Outcome|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab administered IV..
11378571|NCT04427501|EG000|Reported Event|Phase 2: Placebo|Participants received Placebo administered intravenously (IV).
11378572|NCT04427501|EG001|Reported Event|Phase 2: 700 mg Bamlanivimab|Participants received 700 mg bamlanivimab administered IV.
11378573|NCT04427501|EG002|Reported Event|Phase 2: 2800 mg Bamlanivimab|Participants received 2800 mg bamlanivimab administered IV.
11378574|NCT04427501|EG003|Reported Event|Phase 2: 7000 mg Bamlanivimab|Participants received 7000 mg bamlanivimab administered IV.
11378575|NCT04427501|EG004|Reported Event|Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378576|NCT04427501|EG005|Reported Event|Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab|Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
11378577|NCT04427501|EG006|Reported Event|Phase 3: Placebo|Participants received Placebo administered intravenously (IV).
11378578|NCT04427501|EG007|Reported Event|Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab|Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
11378579|NCT04427501|EG008|Reported Event|Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received Placebo administered intravenously (IV).
11378580|NCT04427501|EG009|Reported Event|Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab|Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
11378581|NCT03735849|BG000|Baseline|Group 1: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
11378582|NCT03735849|BG001|Baseline|Group 2: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
11339653|NCT03634579|EG000|Reported Event|MRI-guided Focal Laser Ablation|Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
10800826|NCT02787499|BG000|Baseline|Standard of Care|Follows the 2013 World Health Organization (WHO) HIV treatment guidelines. Study participants will receive adherence support and return for a repeat viral load test in 3 months (or in 1 month for pregnant participants). Treatment failure will be defined by two consecutive viral load measurements greater than 1,000 copies/mL. Participants who meet this criteria will be switched to second-line therapy. Those with a viral load <1,000 copies/mL at repeat testing will be retained on first-line therapy.
10964273|NCT00876460|OG000|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
10964274|NCT00876460|OG001|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
11378583|NCT03735849|BG002|Baseline|Group 3: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11378584|NCT03735849|BG003|Baseline|Total|Total of all reporting groups
10800827|NCT02787499|BG001|Baseline|HIV-1 RNA Resistance Testing|"Participants will receive HIV-1 RNA drug resistance testing at study enrollment. ART treatment regimen decisions will be determined based on the results of resistance testing.~HIV-1 RNA Resistance Testing: Perform drug resistance on enrollment to guide management of virologic failure"
10800828|NCT02787499|BG002|Baseline|Total|Total of all reporting groups
11192828|NCT02141399|EG000|Reported Event|ALKS 5461|ALKS 5461 adjunctive treatment
11192829|NCT02141451|BG000|Baseline|INCB7839 100 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192830|NCT02141451|BG001|Baseline|INCB7839 200 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192831|NCT02141451|BG002|Baseline|INCB7839 300 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192832|NCT02141451|BG003|Baseline|INCB7839 300 mg (Phase II)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192833|NCT02141451|BG004|Baseline|Total|Total of all reporting groups
11192834|NCT02141451|FG000|Participant Flow|INCB7839 100 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192835|NCT02141451|FG001|Participant Flow|INCB7839 200 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192836|NCT02141451|FG002|Participant Flow|INCB7839 300 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192837|NCT02141451|FG003|Participant Flow|INCB7839 300 mg (Phase II)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192838|NCT02141451|OG000|Outcome|INCB7839 100 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192839|NCT02141451|OG001|Outcome|INCB7839 200 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
10964275|NCT00876460|OG002|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
11378585|NCT03735849|FG000|Participant Flow|Group 1: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
11378586|NCT03735849|FG001|Participant Flow|Group 2: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
11378587|NCT03735849|FG002|Participant Flow|Group 3: Pre-treatment|Biopsy collected but was not randomized to any treatment group
10800829|NCT02787499|FG000|Participant Flow|Standard of Care|Follows the 2013 World Health Organization (WHO) HIV treatment guidelines. Study participants will receive adherence support and return for a repeat viral load test in 3 months (or in 1 month for pregnant participants). Treatment failure will be defined by two consecutive viral load measurements greater than 1,000 copies/mL. Participants who meet this criteria will be switched to second-line therapy. Those with a viral load <1,000 copies/mL at repeat testing will be retained on first-line therapy.
10800830|NCT02787499|FG001|Participant Flow|HIV-1 RNA Resistance Testing|"Participants will receive HIV-1 RNA drug resistance testing at study enrollment. ART treatment regimen decisions will be determined based on the results of resistance testing.~HIV-1 RNA Resistance Testing: Perform drug resistance on enrollment to guide management of virologic failure"
11378588|NCT03735849|OG000|Outcome|Group 1: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
11378589|NCT03735849|OG001|Outcome|Group 2: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
11378590|NCT03735849|EG000|Reported Event|Group 1: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32
11378591|NCT03735849|EG001|Reported Event|Group 2: Vaccine|VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32
11378592|NCT03735849|EG002|Reported Event|Group 3: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11378593|NCT03552822|BG000|Baseline|ERAS Implemented Group|"Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.~ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation"
11378594|NCT03552822|BG001|Baseline|Pre-ERAS - Non-ERAS Implemented Group|Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
11378595|NCT03552822|BG002|Baseline|Total|Total of all reporting groups
11378596|NCT03552822|FG000|Participant Flow|ERAS Implemented Group|"Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.~ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation"
11378597|NCT03552822|FG001|Participant Flow|Pre-ERAS - Non-ERAS Implemented Group|Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
11378598|NCT03552822|OG000|Outcome|ERAS Implemented Group|"Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.~ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation"
11378599|NCT03552822|OG001|Outcome|Pre-ERAS - Non-ERAS Implemented Group|Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
11378600|NCT03552822|EG000|Reported Event|ERAS Implemented Group|"Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.~ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation"
11378601|NCT03552822|EG001|Reported Event|Pre-ERAS - Non-ERAS Implemented Group|Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
11378602|NCT03552393|BG000|Baseline|Mircera|Mircera was administered subcutaneously once every 4 weeks.
11378603|NCT03552393|FG000|Participant Flow|Mircera|Mircera was administered subcutaneously once every 4 weeks.
11378604|NCT03552393|OG000|Outcome|Mircera|Mircera was administered subcutaneously once every 4 weeks.
11378605|NCT03552393|EG000|Reported Event|Mircera|Mircera was administered subcutaneously once every 4 weeks.
11339664|NCT03634813|OG001|Outcome|Usual Care|"The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.~Usual Care: Usual Care"
11339665|NCT03634813|OG001|Outcome|Usual Care|"The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines; they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.~Usual Care: Usual Care"
11339666|NCT03634813|EG000|Reported Event|High Blood Pressure Monitoring and Counseling|"Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure, which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.~High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)"
11339667|NCT03634813|EG001|Reported Event|Usual Care|"The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines; they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.~Usual Care: Usual Care"
11339668|NCT03635086|BG000|Baseline|Group A: Two MV-CHIK Lyophilized Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
11339669|NCT03635086|BG001|Baseline|Group B: Two MV-CHIK Liquid Frozen Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11339670|NCT03635086|BG002|Baseline|Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11339671|NCT03635086|BG003|Baseline|Group D: Two MV-CHIK Liquid Frozen High Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
11339672|NCT03635086|BG004|Baseline|Group E: One MV-CHIK Liquid Frozen High Dose|Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
11339673|NCT03635086|BG005|Baseline|Total|Total of all reporting groups
11339674|NCT03635086|FG000|Participant Flow|Group A: Two Measles Virus-Chikungunya (MV-CHIK) Lyophilized Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
11339675|NCT03635086|FG001|Participant Flow|Group B: Two MV-CHIK Liquid Frozen Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11339676|NCT03635086|FG002|Participant Flow|Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11339677|NCT03635086|FG003|Participant Flow|Group D: Two MV-CHIK Liquid Frozen High Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
11339678|NCT03635086|FG004|Participant Flow|Group E: One MV-CHIK Liquid Frozen High Dose|Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
11339679|NCT03635086|OG000|Outcome|Group A: Two MV-CHIK Lyophilized Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
11339680|NCT03635086|OG001|Outcome|Group B: Two MV-CHIK Liquid Frozen Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11339681|NCT03635086|OG002|Outcome|Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
11378606|NCT03412747|BG000|Baseline|Bimekizumab 320 Milligrams (mg) Q4W/Q8W|Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378607|NCT03412747|BG001|Baseline|Bimekizumab 320 mg Q4W|Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378608|NCT03412747|BG002|Baseline|Adalimumab|Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378609|NCT03412747|BG003|Baseline|Total Title|
11378610|NCT03412747|FG000|Participant Flow|Bimekizumab 320 Milligrams (mg) Q4W/Q8W|Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378611|NCT03412747|FG001|Participant Flow|Bimekizumab 320 mg Q4W|Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378612|NCT03412747|FG002|Participant Flow|Adalimumab|Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
11378613|NCT03412747|OG000|Outcome|Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS)|This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
11378614|NCT03412747|OG001|Outcome|Adalimumab (RS)|Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
11378615|NCT03412747|OG000|Outcome|Bimekizumab 320 mg Q4W/Q8W (RS)|Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
11378616|NCT03412747|OG001|Outcome|Bimekizumab 320 mg Q4W (RS)|Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
11378617|NCT03412747|OG002|Outcome|Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS)|This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).
11378618|NCT03412747|OG003|Outcome|Adalimumab (RS)|Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
11378619|NCT03412747|OG000|Outcome|Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS)|Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).
11378620|NCT03412747|OG001|Outcome|Bimekizumab 320 mg Q4W Through Week 24 (SS)|Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
11378621|NCT03412747|OG002|Outcome|Adalimumab Through Week 24 (SS)|Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
11378622|NCT03412747|OG000|Outcome|Any Bimekizumab 320 mg Q8W (BKZ Set)|This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
11378623|NCT03412747|OG001|Outcome|Any Bimekizumab 320 mg Q4W (BKZ Set)|This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
11378624|NCT03412747|EG000|Reported Event|Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS)|Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).
11378625|NCT03412747|EG001|Reported Event|Bimekizumab 320 mg Q4W Through Week 24 (SS)|Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
11378626|NCT03412747|EG002|Reported Event|Adalimumab Through Week 24 (SS)|Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
11378627|NCT03412747|EG003|Reported Event|Any Bimekizumab 320 mg Q8W (BKZ Set)|This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
11378628|NCT03412747|EG004|Reported Event|Any Bimekizumab 320 mg Q4W (BKZ Set)|This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
11202187|NCT02205983|BG001|Baseline|4 mg Hydromorphone|Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion
11378629|NCT03333382|BG000|Baseline|Plastic Biliary Stent|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak."
11378630|NCT03333382|BG001|Baseline|FCSEMS|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak."
11378631|NCT03333382|BG002|Baseline|Total|Total of all reporting groups
11192840|NCT02141451|OG002|Outcome|INCB7839 300 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192841|NCT02141451|OG001|Outcome|INCB7839 200 mg (Phase I)|Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
11192842|NCT02141451|OG002|Outcome|INCB7839 300 mg (Phase I)|Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
11192843|NCT02141451|OG003|Outcome|INCB7839 300 mg (Phase II)|Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
11192844|NCT02141451|OG003|Outcome|INCB7839 300 mg (Phase II)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192845|NCT02141451|EG000|Reported Event|INCB7839 100 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192846|NCT02141451|EG001|Reported Event|INCB7839 200 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192847|NCT02141451|EG002|Reported Event|INCB7839 300 mg (Phase I)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192848|NCT02141451|EG003|Reported Event|INCB7839 300 mg (Phase II)|"Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab~Rituximab: Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later~INCB7839: INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab"
11192849|NCT02141490|BG000|Baseline|Prostate Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192850|NCT02141490|BG001|Baseline|Bladder Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192851|NCT02141490|BG002|Baseline|Kidney Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192852|NCT02141490|BG003|Baseline|Total|Total of all reporting groups
11192853|NCT02141490|FG000|Participant Flow|Prostate Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192854|NCT02141490|FG001|Participant Flow|Bladder Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192855|NCT02141490|FG002|Participant Flow|Kidney Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192856|NCT02141490|OG000|Outcome|All Participants|"Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.~Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
10800831|NCT02787499|OG000|Outcome|Standard of Care|Follows the 2013 World Health Organization (WHO) HIV treatment guidelines. Study participants will receive adherence support and return for a repeat viral load test in 3 months (or in 1 month for pregnant participants). Treatment failure will be defined by two consecutive viral load measurements greater than 1,000 copies/mL. Participants who meet this criteria will be switched to second-line therapy. Those with a viral load <1,000 copies/mL at repeat testing will be retained on first-line therapy.
10800832|NCT02787499|OG001|Outcome|HIV-1 RNA Resistance Testing|"Participants will receive HIV-1 RNA drug resistance testing at study enrollment. ART treatment regimen decisions will be determined based on the results of resistance testing.~HIV-1 RNA Resistance Testing: Perform drug resistance on enrollment to guide management of virologic failure"
10800833|NCT02787499|EG000|Reported Event|Standard of Care|Follows the 2013 World Health Organization (WHO) HIV treatment guidelines. Study participants will receive adherence support and return for a repeat viral load test in 3 months (or in 1 month for pregnant participants). Treatment failure will be defined by two consecutive viral load measurements greater than 1,000 copies/mL. Participants who meet this criteria will be switched to second-line therapy. Those with a viral load <1,000 copies/mL at repeat testing will be retained on first-line therapy.
10800834|NCT02787499|EG001|Reported Event|HIV-1 RNA Resistance Testing|"Participants will receive HIV-1 RNA drug resistance testing at study enrollment. ART treatment regimen decisions will be determined based on the results of resistance testing.~HIV-1 RNA Resistance Testing: Perform drug resistance on enrollment to guide management of virologic failure"
10803652|NCT02864407|FG000|Participant Flow|Vahelva® Respimat® (Tiotropium + Olodaterol Fixed Dose Combination)|Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination) was prescribed according to the local label and at the discretion of the treating physician. The recommended dose for adults is 5 microgram Tiotropium and 5 microgram Olodaterol given as two puffs from the Respimat® inhaler once daily at the same time of the day. Each puff contains 2.5 microgram Tiotropium and 2.5 microgram Olodaterol.
10803653|NCT02864407|OG000|Outcome|Vahelva® Respimat® (Tiotropium + Olodaterol Fixed Dose Combination)|Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination) was prescribed according to the local label and at the discretion of the treating physician. The recommended dose for adults is 5 microgram Tiotropium and 5 microgram Olodaterol given as two puffs from the Respimat® inhaler once daily at the same time of the day. Each puff contains 2.5 microgram Tiotropium and 2.5 microgram Olodaterol.
11192857|NCT02141490|OG000|Outcome|All Participants|"Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.~Ferumoxytol + Magnetic Resonance Imaging (MRI) Ferumoxytol: 7.5mg/kg intravenous (IV) infusion Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192858|NCT02141490|OG000|Outcome|Prostate Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192859|NCT02141490|OG001|Outcome|Bladder Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11378632|NCT03333382|FG000|Participant Flow|Plastic Biliary Stent|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak."
11378633|NCT03333382|FG001|Participant Flow|FCSEMS|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak."
11378634|NCT03333382|OG000|Outcome|Plastic Biliary Stent|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak."
11378635|NCT03333382|OG001|Outcome|FCSEMS|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak."
11378636|NCT03333382|EG000|Reported Event|Plastic Biliary Stent|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak."
11378637|NCT03333382|EG001|Reported Event|FCSEMS|"Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP).~FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak."
11378638|NCT03245827|BG000|Baseline|Obese Males With Hypogonadism-active|"Subjects will be randomized to receive clomiphene capsules~Clomiphene: clomiphene capsule 25mg twice a week"
11378639|NCT03245827|BG001|Baseline|Obese Males With Hypogonadism-placebo|"Subjects will be randomized to receive placebo capsules~Placebo: placebo capsule 25mg twice a week"
11378640|NCT03245827|BG002|Baseline|Obese Males With Normal Testosterone|comparison group
11378641|NCT03245827|BG003|Baseline|Lean Males With Normal Testosterone|comparison group
11192860|NCT02141490|OG002|Outcome|Kidney Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192861|NCT02141490|EG000|Reported Event|Prostate Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11378642|NCT03245827|BG004|Baseline|Total|Total of all reporting groups
11378643|NCT03245827|FG000|Participant Flow|Obese Males With Hypogonadism-active|"Subjects will be randomized to receive clomiphene capsules~Clomiphene: clomiphene capsule 25mg twice a week"
11378644|NCT03245827|FG001|Participant Flow|Obese Males With Hypogonadism-placebo|"Subjects will be randomized to receive placebo capsules~Placebo: placebo capsule 25mg twice a week"
11378645|NCT03245827|FG002|Participant Flow|Obese Males With Normal Testosterone|comparison group
11378646|NCT03245827|FG003|Participant Flow|Lean Males With Normal Testosterone|comparison group
11378647|NCT03245827|OG000|Outcome|Obese Males With Hypogonadism-active|"Subjects will be randomized to receive clomiphene capsules~Clomiphene: clomiphene capsule 25mg twice a week"
11378648|NCT03245827|OG001|Outcome|Obese Males With Hypogonadism-placebo|"Subjects will be randomized to receive placebo capsules~Placebo: placebo capsule 25mg twice a week"
11378649|NCT03245827|EG000|Reported Event|Obese Males With Hypogonadism-active|"Subjects will be randomized to receive clomiphene capsules~Clomiphene: clomiphene capsule 25mg twice a week"
11378650|NCT03245827|EG001|Reported Event|Obese Males With Hypogonadism-placebo|"Subjects will be randomized to receive placebo capsules~Placebo: placebo capsule 25mg twice a week"
11378651|NCT03245827|EG002|Reported Event|Obese Males With Normal Testosterone|comparison group
11378652|NCT03245827|EG003|Reported Event|Lean Males With Normal Testosterone|comparison group
11378653|NCT03129321|BG000|Baseline|Test|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378654|NCT03129321|BG001|Baseline|Reference Standard|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378655|NCT03129321|BG002|Baseline|Placebo|"Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Placebo"
11378656|NCT03129321|BG003|Baseline|Total|Total of all reporting groups
11378657|NCT03129321|FG000|Participant Flow|Test|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11192862|NCT02141490|EG001|Reported Event|Bladder Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192863|NCT02141490|EG002|Reported Event|Kidney Cancer|"Ferumoxytol + Magnetic Resonance Imaging (MRI)~Ferumoxytol: 7.5mg/kg intravenous (IV) infusion~Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion"
11192864|NCT02141516|BG000|Baseline|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192865|NCT02141516|BG001|Baseline|Asplenia|Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192866|NCT02141516|BG002|Baseline|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
10800835|NCT02765399|BG000|Baseline|Liraglutide|"Liraglutide subcutaneous injection once daily with following dose escalation:~liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.~Liraglutide"
10800836|NCT02765399|BG001|Baseline|Placebo|"Placebo subcutaneous injection once daily with following dose escalation:~placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months."
10800837|NCT02765399|BG002|Baseline|Total|Total of all reporting groups
11192867|NCT02141516|BG003|Baseline|Total|Total of all reporting groups
10800838|NCT02765399|FG000|Participant Flow|Liraglutide|"Liraglutide subcutaneous injection once daily with following dose escalation:~liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.~Liraglutide"
10800839|NCT02765399|FG001|Participant Flow|Placebo|Placebo subcutaneous injection once daily with following dose escalation: placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months.
11192868|NCT02141516|FG000|Participant Flow|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192869|NCT02141516|FG001|Participant Flow|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192870|NCT02141516|FG002|Participant Flow|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192871|NCT02141516|OG000|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192872|NCT02141516|OG001|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192873|NCT02141516|OG002|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
10800840|NCT02765399|OG000|Outcome|Liraglutide|"Liraglutide subcutaneous injection once daily with following dose escalation:~liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.~Liraglutide"
10964276|NCT00876460|EG000|Reported Event|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10800841|NCT02765399|OG001|Outcome|Placebo|"Placebo subcutaneous injection once daily with following dose escalation:~placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months."
11192874|NCT02141516|OG003|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
10800842|NCT02765399|EG000|Reported Event|Liraglutide|"Liraglutide subcutaneous injection once daily with following dose escalation:~liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.~Liraglutide"
10800843|NCT02765399|EG001|Reported Event|Placebo|Placebo subcutaneous injection once daily with following dose escalation: placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months.
11192875|NCT02141516|OG004|Outcome|Total|Total of subjects
11192876|NCT02141516|EG000|Reported Event|CompDef|Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192877|NCT02141516|EG001|Reported Event|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192878|NCT02141516|EG002|Reported Event|CompDef + Asplenia|Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192879|NCT02141516|EG003|Reported Event|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
11192880|NCT02141516|EG004|Reported Event|Total|Total number of Subjects
11192881|NCT02141555|BG000|Baseline|Vaginal Misoprostol|"Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.~Vaginal Misoprostol: Misoprostol inserted into vagina"
11192882|NCT02141555|BG001|Baseline|Buccal Misoprostol|"Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.~Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time."
11192883|NCT02141555|BG002|Baseline|Total|Total of all reporting groups
11192884|NCT02141555|FG000|Participant Flow|Vaginal Misoprostol|"Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.~Vaginal Misoprostol: Misoprostol inserted into vagina"
11192885|NCT02141555|FG001|Participant Flow|Buccal Misoprostol|"Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.~Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time."
11192886|NCT02141555|OG000|Outcome|Vaginal Misoprostol|"Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.~Vaginal Misoprostol: Misoprostol inserted into vagina"
11192887|NCT02141555|OG001|Outcome|Buccal Misoprostol|"Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.~Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time."
11192888|NCT02141555|EG000|Reported Event|Vaginal Misoprostol|"Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.~Vaginal Misoprostol: Misoprostol inserted into vagina"
11339682|NCT03635086|OG003|Outcome|Group D: Two MV-CHIK Liquid Frozen High Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
10800844|NCT04529096|BG000|Baseline|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
11192889|NCT02141555|EG001|Reported Event|Buccal Misoprostol|"Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.~Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time."
11192890|NCT02141581|BG000|Baseline|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
11192891|NCT02141581|BG001|Baseline|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
11192892|NCT02141581|BG002|Baseline|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
11192893|NCT02141581|BG003|Baseline|Total|Total of all reporting groups
11192894|NCT02141581|FG000|Participant Flow|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
11192895|NCT02141581|FG001|Participant Flow|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
11192896|NCT02141581|FG002|Participant Flow|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
11192897|NCT02141581|OG000|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
11192898|NCT02141581|OG001|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
11192899|NCT02141581|OG002|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
11192900|NCT02141581|EG000|Reported Event|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
11192901|NCT02141581|EG001|Reported Event|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
11192902|NCT02141581|EG002|Reported Event|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
11192903|NCT02141620|BG000|Baseline|All Study Participants|All subjects who completed the study.
11192904|NCT02141620|FG000|Participant Flow|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
11192905|NCT02141620|FG001|Participant Flow|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
11192906|NCT02141620|OG000|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
11192907|NCT02141620|OG001|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
11192908|NCT02141620|EG000|Reported Event|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
11192909|NCT02141620|EG001|Reported Event|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
11192910|NCT02141633|BG000|Baseline|Smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
10800845|NCT04529096|BG001|Baseline|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10800846|NCT04529096|BG002|Baseline|Total|Total of all reporting groups
11192911|NCT02141633|BG001|Baseline|Non-smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
11192912|NCT02141633|BG002|Baseline|Total|Total of all reporting groups
11192913|NCT02141633|FG000|Participant Flow|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
11192914|NCT02141633|FG001|Participant Flow|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
11192915|NCT02141633|OG000|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
11192916|NCT02141633|OG001|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
11192917|NCT02141633|EG000|Reported Event|Smokers|No AE or SAE had occurred
11192918|NCT02141633|EG001|Reported Event|Non-smokers|No AE or SAE had occurred
11192919|NCT02141659|BG000|Baseline|Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
10964277|NCT00876460|EG001|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10964278|NCT00876460|EG002|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
10800847|NCT04529096|FG000|Participant Flow|750 Mg-500 Milligram (mg) LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
11192920|NCT02141659|BG001|Baseline|Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192921|NCT02141659|BG002|Baseline|Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192922|NCT02141659|BG003|Baseline|Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg|TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192923|NCT02141659|BG004|Baseline|Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
10800848|NCT04529096|FG001|Participant Flow|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10800849|NCT04529096|OG000|Outcome|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
11192924|NCT02141659|BG005|Baseline|Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192925|NCT02141659|BG006|Baseline|Total|Total of all reporting groups
11192926|NCT02141659|FG000|Participant Flow|Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192927|NCT02141659|FG001|Participant Flow|Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192928|NCT02141659|FG002|Participant Flow|Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192929|NCT02141659|FG003|Participant Flow|Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg|TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192930|NCT02141659|FG004|Participant Flow|Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192931|NCT02141659|FG005|Participant Flow|Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192932|NCT02141659|OG000|Outcome|Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192933|NCT02141659|OG001|Outcome|Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192934|NCT02141659|OG002|Outcome|Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192935|NCT02141659|OG003|Outcome|Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg|TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192936|NCT02141659|OG000|Outcome|Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192937|NCT02141659|OG001|Outcome|Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192938|NCT02141659|EG000|Reported Event|Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192939|NCT02141659|EG001|Reported Event|Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192940|NCT02141659|EG002|Reported Event|Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192941|NCT02141659|EG003|Reported Event|Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg|TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
11192942|NCT02141659|EG004|Reported Event|Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192943|NCT02141659|EG005|Reported Event|Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg|TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
11192944|NCT02141672|BG000|Baseline|Voclosporin Low Dose|Voclosporin oral 23.7 mg (3 capsules) BID
10800850|NCT04529096|OG001|Outcome|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
11192945|NCT02141672|BG001|Baseline|Voclosporin High Dose|Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
11192946|NCT02141672|BG002|Baseline|Placebo|Placebo capsules matched to high dose or low dose voclosporin regimen.
11192947|NCT02141672|BG003|Baseline|Total|Total of all reporting groups
11192948|NCT02141672|FG000|Participant Flow|Voclosporin Low Dose|Voclosporin oral 23.7 mg (3 capsules) BID
11192949|NCT02141672|FG001|Participant Flow|Voclosporin High Dose|Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
11192950|NCT02141672|FG002|Participant Flow|Placebo|Placebo capsules matched to high dose or low dose voclosporin regimen.
11192951|NCT02141672|OG000|Outcome|Voclosporin Low Dose|Voclosporin oral 23.7 mg (3 capsules) BID
11192952|NCT02141672|OG001|Outcome|Voclosporin High Dose|Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
11192953|NCT02141672|OG002|Outcome|Placebo|Placebo capsules matched to high dose or low dose voclosporin regimen.
11192954|NCT02141672|EG000|Reported Event|Voclosporin Low Dose|Voclosporin oral 23.7 mg (3 capsules) BID
11192955|NCT02141672|EG001|Reported Event|Voclosporin High Dose|Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
11192956|NCT02141672|EG002|Reported Event|Placebo|Placebo capsules matched to high dose or low dose voclosporin regimen.
11192957|NCT02141854|BG000|Baseline|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192958|NCT02141854|BG001|Baseline|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11378658|NCT03129321|FG001|Participant Flow|Reference Standard|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378659|NCT03129321|FG002|Participant Flow|Placebo|"Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Placebo"
11378660|NCT03129321|OG000|Outcome|Test|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378661|NCT03129321|OG001|Outcome|Reference Standard|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378662|NCT03129321|OG002|Outcome|Placebo|"Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Placebo"
11378663|NCT03129321|OG002|Outcome|Placebo|Placebo Cream, topical,
11378664|NCT03129321|OG002|Outcome|Placebo|"Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Placebo Cream"
11378665|NCT03129321|EG000|Reported Event|Test|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378666|NCT03129321|EG001|Reported Event|Reference Standard|"Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Econazole Nitrate Cream, 1%"
11378667|NCT03129321|EG002|Reported Event|Placebo|"Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days~Placebo"
11378668|NCT03107611|BG000|Baseline|Test|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378669|NCT03107611|BG001|Baseline|Reference Standard|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378670|NCT03107611|BG002|Baseline|Placebo|"Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days~Placebo Cream"
11378671|NCT03107611|BG003|Baseline|Total|Total of all reporting groups
11378672|NCT03107611|FG000|Participant Flow|Test|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378673|NCT03107611|FG001|Participant Flow|Reference Standard|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378674|NCT03107611|FG002|Participant Flow|Placebo|"Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days~Placebo Cream"
11378675|NCT03107611|OG000|Outcome|Test|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378676|NCT03107611|OG001|Outcome|Reference Standard|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378677|NCT03107611|OG002|Outcome|Placebo|"Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days~Placebo Cream"
11378678|NCT03107611|EG000|Reported Event|Test|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378679|NCT03107611|EG001|Reported Event|Reference Standard|"Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days~Pimecrolimus Cream, 1%"
11378680|NCT03107611|EG002|Reported Event|Placebo|"Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days~Placebo Cream"
11378681|NCT02720016|BG000|Baseline|CBCT-Home Based (CBCT-HB)|"Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).~CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT)."
11378682|NCT02720016|BG001|Baseline|CBCT-Office Based (CBCT-OB)|"Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.~CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office."
11378683|NCT02720016|BG002|Baseline|PTSD Family Education (PFE)|"Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.~PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office."
11378684|NCT02720016|BG003|Baseline|Total|Total of all reporting groups
11192959|NCT02141854|BG002|Baseline|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192960|NCT02141854|BG003|Baseline|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192961|NCT02141854|BG004|Baseline|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192962|NCT02141854|BG005|Baseline|Total|Total of all reporting groups
11192963|NCT02141854|FG000|Participant Flow|Fluticasone Propionate 50 mcg BID|All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
11192964|NCT02141854|FG001|Participant Flow|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192965|NCT02141854|FG002|Participant Flow|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10964279|NCT00876460|EG003|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192966|NCT02141854|FG003|Participant Flow|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800851|NCT04529096|EG000|Reported Event|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
10800852|NCT04529096|EG001|Reported Event|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses
11192967|NCT02141854|FG004|Participant Flow|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192968|NCT02141854|FG005|Participant Flow|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11202188|NCT02205983|BG002|Baseline|1000 mg Acetaminophen|Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.
10964280|NCT00876460|EG004|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192969|NCT02141854|OG000|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11202189|NCT02205983|BG003|Baseline|Dextrose (Placebo)|Healthy adult volunteers will receive Dextrose (placebo).
11202190|NCT02205983|BG004|Baseline|Total|Total of all reporting groups
11202191|NCT02205983|FG000|Participant Flow|2 mg Hydromorphone|
11202192|NCT02205983|FG001|Participant Flow|4 mg Hydromorphone|
10800853|NCT04468074|BG000|Baseline|Therapy Group|"Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:~An education session on the science behind chronic pain and a basic overview of the VR therapy.~A session to customize the VR experience to match the participant's own pain experience.~A training session on the use of the VR hardware and software.~Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.~Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.~Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises"
10800854|NCT04468074|BG001|Baseline|Standard of Care (SOC) Group|The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
10800855|NCT04468074|BG002|Baseline|Total|Total of all reporting groups
10800856|NCT04468074|FG000|Participant Flow|Therapy Group|"Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:~An education session on the science behind chronic pain and a basic overview of the VR therapy.~A session to customize the VR experience to match the participant's own pain experience.~A training session on the use of the VR hardware and software.~Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.~Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.~Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises"
10800857|NCT04468074|FG001|Participant Flow|Standard of Care (SOC) Group|The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
10803654|NCT02864407|EG000|Reported Event|Vahelva® Respimat® (Tiotropium + Olodaterol Fixed Dose Combination)|Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination) was prescribed according to the local label and at the discretion of the treating physician. The recommended dose for adults is 5 microgram Tiotropium and 5 microgram Olodaterol given as two puffs from the Respimat® inhaler once daily at the same time of the day. Each puff contains 2.5 microgram Tiotropium and 2.5 microgram Olodaterol.
11202193|NCT02205983|FG002|Participant Flow|1000 mg Acetaminophen|
11202194|NCT02205983|FG003|Participant Flow|Dextrose (Placebo)|
11192970|NCT02141854|OG001|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192971|NCT02141854|OG002|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192972|NCT02141854|OG003|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192973|NCT02141854|OG004|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11202195|NCT02205983|OG000|Outcome|2 mg Hydromophone|"Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.~2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task."
11192974|NCT02141854|EG000|Reported Event|FS MDPI 100/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192975|NCT02141854|EG001|Reported Event|FS MDPI 200/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192976|NCT02141854|EG002|Reported Event|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192977|NCT02141854|EG003|Reported Event|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11192978|NCT02141854|EG004|Reported Event|Placebo|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10964281|NCT00876460|EG005|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11192979|NCT02141867|BG000|Baseline|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
11192980|NCT02141867|FG000|Participant Flow|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
11192981|NCT02141867|OG000|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
11192982|NCT02141867|EG000|Reported Event|Non Cardiac Surgery|Non cardiac surgery patients 16 years or older
11192983|NCT02141984|BG000|Baseline|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
11192984|NCT02141984|FG000|Participant Flow|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
11192985|NCT02141984|OG000|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
11192986|NCT02141984|EG000|Reported Event|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
11192987|NCT02141997|BG000|Baseline|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
11192988|NCT02141997|BG001|Baseline|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
11192989|NCT02141997|BG002|Baseline|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
11192990|NCT02141997|BG003|Baseline|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
11192991|NCT02141997|BG004|Baseline|Total|Total of all reporting groups
11192992|NCT02141997|FG000|Participant Flow|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
11192993|NCT02141997|FG001|Participant Flow|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
11192994|NCT02141997|FG002|Participant Flow|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
11192995|NCT02141997|FG003|Participant Flow|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
11192996|NCT02141997|OG000|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
11192997|NCT02141997|OG001|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
11192998|NCT02141997|OG002|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
11192999|NCT02141997|OG003|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
11193000|NCT02141997|EG000|Reported Event|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
11193001|NCT02141997|EG001|Reported Event|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
11339683|NCT03635086|OG004|Outcome|Group E: One MV-CHIK Liquid Frozen High Dose|Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
10800858|NCT04468074|OG000|Outcome|Therapy Group|"Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:~An education session on the science behind chronic pain and a basic overview of the VR therapy.~A session to customize the VR experience to match the participant's own pain experience.~A training session on the use of the VR hardware and software.~Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.~Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.~Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises"
10800859|NCT04468074|OG001|Outcome|Standard of Care (SOC) Group|The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
10803655|NCT02846532|BG000|Baseline|Rivaroxaban (Part A)|Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
10776534|NCT04884191|BG000|Baseline|Pacritinib 100 mg QD|Pacritinib: Pacritinib
10776535|NCT04884191|BG001|Baseline|Pacritinib 100 mg BID|Pacritinib: Pacritinib
10776536|NCT04884191|BG002|Baseline|Pacritinib 200 mg BID|Pacritinib: Pacritinib
10776537|NCT04884191|BG003|Baseline|Total|Total of all reporting groups
10776538|NCT04884191|FG000|Participant Flow|Pacritinib 100 mg QD|Pacritinib: Pacritinib
10776539|NCT04884191|FG001|Participant Flow|Pacritinib 100 mg BID|Pacritinib: Pacritinib
10776540|NCT04884191|FG002|Participant Flow|Pacritinib 200 mg BID|Pacritinib: Pacritinib
10776541|NCT04884191|OG000|Outcome|Pacritinib 100 mg QD|Pacritinib: Pacritinib
10776542|NCT04884191|OG001|Outcome|Pacritinib 100 mg BID|Pacritinib: Pacritinib
10776543|NCT04884191|OG002|Outcome|Pacritinib 200 mg BID|Pacritinib: Pacritinib
10776544|NCT04884191|EG000|Reported Event|Pacritinib 100 mg QD|Pacritinib: Pacritinib
10776545|NCT04884191|EG001|Reported Event|Pacritinib 100 mg BID|Pacritinib: Pacritinib
10776546|NCT04884191|EG002|Reported Event|Pacritinib 200 mg BID|Pacritinib: Pacritinib
10776547|NCT04881175|BG000|Baseline|FlexSure Applicator|"The TempSure FlexSure applicator will be used on the abdomen or flanks.~Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device."
10776548|NCT04881175|FG000|Participant Flow|FlexSure Applicator|"The TempSure FlexSure applicator will be used on the abdomen or flanks.~Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device."
10776549|NCT04881175|OG000|Outcome|FlexSure Applicator|"The TempSure FlexSure applicator will be used on the abdomen or flanks.~Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device."
10776550|NCT04881175|EG000|Reported Event|FlexSure Applicator|"The TempSure FlexSure applicator will be used on the abdomen or flanks.~Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device."
10776551|NCT04881149|BG000|Baseline|TempSure Device|"The TempSure will be used on the flanks during this study.~TempSure treatment: Self-controlled, single-arm study using the TempSure device."
10776552|NCT04881149|FG000|Participant Flow|All Study Participants|The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
10776553|NCT04881149|OG000|Outcome|All Study Participants|The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
10776554|NCT04881149|EG000|Reported Event|Treatment Flank|The TempSure was used on the flanks during this study. Subjects receive 1 biopsy in the treatment area on the flank. Each subject had 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
10776555|NCT04881149|EG001|Reported Event|Control Flank|Subjects receive 1 biopsy sample on the contralateral side, where they did not receive treatment.
10776556|NCT04600076|BG000|Baseline|BabyCenter Site and the Community Group|BabyCenter site and the community group: Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.
10776557|NCT04600076|FG000|Participant Flow|BabyCenter Site and the Community Group|BabyCenter site and the community group: Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.
10776558|NCT04600076|OG000|Outcome|BabyCenter Site and the Community Group|BabyCenter site and the community group: Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.
10776559|NCT04600076|EG000|Reported Event|BabyCenter Site and the Community Group|BabyCenter site and the community group: Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.
10776560|NCT04375397|BG000|Baseline|Ibrutinib 420 mg + SOC|420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776561|NCT04375397|BG001|Baseline|Placebo + SOC|Three hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776562|NCT04375397|BG002|Baseline|Total|Total of all reporting groups
10776563|NCT04375397|FG000|Participant Flow|Ibrutinib 420 mg + SOC|420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776564|NCT04375397|FG001|Participant Flow|Placebo + SOC|Three hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776565|NCT04375397|OG000|Outcome|Ibrutinib 420 mg + SOC|420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776566|NCT04375397|OG001|Outcome|Placebo + SOC|Three hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776567|NCT04375397|EG000|Reported Event|Ibrutinib 420 mg + SOC|420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
10776568|NCT04375397|EG001|Reported Event|Placebo + SOC|Three hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
11193002|NCT02141997|EG002|Reported Event|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
11193003|NCT02141997|EG003|Reported Event|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
11193004|NCT02142049|BG000|Baseline|Part 1: Dose Level 1|"Ibrutinib 560 mg PO + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193005|NCT02142049|BG001|Baseline|Part 1: Dose Level 2|"Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
10776573|NCT04327518|BG000|Baseline|Tecnis Toric II IOL|Study lens
10776574|NCT04327518|FG000|Participant Flow|Tecnis Toric II IOl|Study Lens
10776575|NCT04327518|OG000|Outcome|Tecnis Toric II IOL|Study lens
10776576|NCT04327518|EG000|Reported Event|Tecnis Toric II IOL|Study lens
10776577|NCT04273737|BG000|Baseline|Amantadine|"Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)~Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary."
10776578|NCT04273737|FG000|Participant Flow|Amantadine|"Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)~Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary."
10776579|NCT04273737|OG000|Outcome|Amantadine|"Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)~Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary."
10776580|NCT04273737|EG000|Reported Event|Amantadine|"Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)~Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary."
10776581|NCT04267276|BG000|Baseline|BI 1265162 - Intravenous|"Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h.~The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq).~Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration."
10776582|NCT04267276|FG000|Participant Flow|BI 1265162 - Intravenous|"Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h.~The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq).~Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration."
10776583|NCT04267276|OG000|Outcome|BI 1265162 - Intravenous|"Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h.~The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq).~Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration."
10776584|NCT04267276|EG000|Reported Event|BI 1265162 - Intravenous|"Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h.~The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq).~Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration."
10800860|NCT04468074|EG000|Reported Event|Therapy Group|"Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:~An education session on the science behind chronic pain and a basic overview of the VR therapy.~A session to customize the VR experience to match the participant's own pain experience.~A training session on the use of the VR hardware and software.~Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.~Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.~Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises"
10800861|NCT04468074|EG001|Reported Event|Standard of Care (SOC) Group|The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
10800862|NCT04456686|BG000|Baseline|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
10800863|NCT04456686|BG001|Baseline|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10800864|NCT04456686|BG002|Baseline|Total|Total of all reporting groups
10800865|NCT04456686|FG000|Participant Flow|750 Mg-500 Milligram (mg) LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
10800866|NCT04456686|FG001|Participant Flow|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10800867|NCT04456686|OG000|Outcome|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
10800868|NCT04456686|OG001|Outcome|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10800869|NCT04456686|EG000|Reported Event|750 Mg-500 mg LY3016859|Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
10800870|NCT04456686|EG001|Reported Event|Placebo|Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
10776585|NCT04255381|BG000|Baseline|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)|"Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system~Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)"
10776586|NCT04255381|FG000|Participant Flow|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)|"Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system~Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)"
10776587|NCT04255381|OG000|Outcome|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)|"Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system~Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)"
10776588|NCT04255381|EG000|Reported Event|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)|"Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system~Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)"
10776589|NCT04075734|BG000|Baseline|RCT Intervention|"The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.~Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules:~(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.~Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call."
10776590|NCT04075734|BG001|Baseline|RCT Usual Care|Participants receive usual care.
10776591|NCT04075734|BG002|Baseline|Mentors|Peer Mentors were recruited and matched 1:1 with each participant randomized to RCT Intervention to facilitate engagement with the online modules and offer specialized support.
10776592|NCT04075734|BG003|Baseline|Total|Total of all reporting groups
10776593|NCT04075734|FG000|Participant Flow|Intervention|"The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.~Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules:~(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.~Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call."
10776594|NCT04075734|FG001|Participant Flow|Usual Care|Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
10776595|NCT04075734|FG002|Participant Flow|Mentors|Peer Mentors were recruited and matched 1:1 with each participant randomized to Intervention to facilitate engagement with the online modules and offer specialized support.
10776596|NCT04075734|OG000|Outcome|Randomized Control Trial Participants-Young Adult Survivors|Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.
10776597|NCT04075734|OG000|Outcome|Intervention|"The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.~Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules:~(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.~Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call."
10964282|NCT00876460|EG006|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11193006|NCT02142049|BG002|Baseline|Part 1: Dose Level 3|"Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193007|NCT02142049|BG003|Baseline|Part 1: Dose Level 4|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193008|NCT02142049|BG004|Baseline|Part 2: RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
10776598|NCT04075734|OG001|Outcome|Usual Care|Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
10776599|NCT04075734|OG001|Outcome|Mentors|Peer Mentors were recruited and matched 1:1 with each participant randomized to Intervention to facilitate engagement with the online modules and offer specialized support.
10800871|NCT03894969|BG000|Baseline|Sh_NTHi-Mcat_1 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.
10800872|NCT03894969|BG001|Baseline|Sh_NTHi-Mcat_3 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.
11193009|NCT02142049|BG005|Baseline|Total|Total of all reporting groups
10776600|NCT04075734|EG000|Reported Event|Intervention|"The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.~Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules:~(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.~Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call."
10776601|NCT04075734|EG001|Reported Event|Usual Care|Participants are not receiving the tested intervention. They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice.
10776602|NCT04075734|EG002|Reported Event|Mentors|Peer Mentors were recruited and matched 1:1 with each participant randomized to RCT Intervention to facilitate engagement with the online modules and offer specialized support.
10776603|NCT04064684|BG000|Baseline|Budesonide Administered by Nebulizer|"Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776604|NCT04064684|BG001|Baseline|Placebo Administered by Nebulizer|"Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776605|NCT04064684|BG002|Baseline|Total|Total of all reporting groups
10776606|NCT04064684|FG000|Participant Flow|Budesonide Administered by Nebulizer|"Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776607|NCT04064684|FG001|Participant Flow|Placebo Administered by Nebulizer|"Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776608|NCT04064684|OG000|Outcome|Budesonide Administered by Nebulizer|"Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776609|NCT04064684|OG001|Outcome|Placebo Administered by Nebulizer|"Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776610|NCT04064684|EG000|Reported Event|Budesonide Administered by Nebulizer|"Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776611|NCT04064684|EG001|Reported Event|Placebo Administered by Nebulizer|"Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.~Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit."
10776612|NCT04048343|BG000|Baseline|Tezepelumab 210mg Q4W|Tezepelumab admistered every 4 weeks subcutaneously
10776613|NCT04048343|FG000|Participant Flow|Tezepelumab 210mg Q4W|Tezepelumab admistered every 4 weeks subcutaneously
10776614|NCT04048343|OG000|Outcome|Tezepelumab 210 Q4W|Tezepelumab administered every 4 weeks subcutaneously
10776615|NCT04048343|EG000|Reported Event|Tezepelumab 210mg Q4W|Tezepelumab admistered every 4 weeks subcutaneously
10800873|NCT03894969|BG002|Baseline|Sh_NTHi-Mcat_6 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.
10800874|NCT03894969|BG003|Baseline|NTHi-Mcat Group|Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.
10776616|NCT04019561|BG000|Baseline|MEDI0382 300 ug|MEDI0382 300 ug
10776617|NCT04019561|BG001|Baseline|MEDI0382 600 ug|MEDI0382 600 ug
10776618|NCT04019561|BG002|Baseline|Placebo|Placebo
10776619|NCT04019561|BG003|Baseline|Total|Total of all reporting groups
10776620|NCT04019561|FG000|Participant Flow|MEDI0382 300 ug|MEDI0382 300 ug
10776621|NCT04019561|FG001|Participant Flow|MEDI0382 600 ug|MEDI0382 600 ug
10776622|NCT04019561|FG002|Participant Flow|Placebo|Placebo
10776623|NCT04019561|OG000|Outcome|MEDI0382 300ug|MEDI0382 300ug
10776624|NCT04019561|OG001|Outcome|MEDI0382 600ug|MEDI0382 600ug
10776625|NCT04019561|OG002|Outcome|Placebo|Placebo
11193010|NCT02142049|FG000|Participant Flow|Part 1: Dose Level 1|"Ibrutinib 560 mg PO + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193011|NCT02142049|FG001|Participant Flow|Part 1: Dose Level 2|"Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193012|NCT02142049|FG002|Participant Flow|Part 1: Dose Level 3|"Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193013|NCT02142049|FG003|Participant Flow|Part 1: Dose Level 4|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193014|NCT02142049|FG004|Participant Flow|Part 2: RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193015|NCT02142049|OG000|Outcome|Part 1: Dose Level 1|"Ibrutinib 560 mg PO + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193016|NCT02142049|OG001|Outcome|Part 1: Dose Level 2|"Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193017|NCT02142049|OG002|Outcome|Part 1: Dose Level 3|"Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193018|NCT02142049|OG003|Outcome|Part 1: Dose Level 4|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193019|NCT02142049|OG004|Outcome|Part 1: All Treated|"Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193020|NCT02142049|OG000|Outcome|All Subjects Treated at RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193021|NCT02142049|OG001|Outcome|ABC Subjects Treated at RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim~Note: There are only 17 samples available for DLBCL subtype test per GEP. Among of them 14 subjects were identified with ABC."
11193022|NCT02142049|OG001|Outcome|ABC Subjects Treated at RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim~Note: There are only 17 samples available for DLBCL subtype test per GEP. Among them 14 subjects were identified with ABC."
11193023|NCT02142049|OG000|Outcome|All Subjects Treated at RP2D Who Achieved Overall Response|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193024|NCT02142049|OG001|Outcome|ABC Subjects Treated at RP2D Who Achieved Overall Response|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim~Note: There are only 17 samples available for DLBCL subtype test per GEP. Among of them 14 subjects were identified with ABC."
11193025|NCT02142049|EG000|Reported Event|Part 1: Dose Level 1|"Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 0 (PO)~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193026|NCT02142049|EG001|Reported Event|Part 1: Dose Level 2|"Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 15 (PO)~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193027|NCT02142049|EG002|Reported Event|Part 1: Dose Level 3|"Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 20 (PO)~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
10776626|NCT04019561|EG000|Reported Event|MEDI0382 300 ug|MEDI0382 300 ug
10776627|NCT04019561|EG001|Reported Event|MEDI0382 600 ug|MEDI0382 600 ug
10776628|NCT04019561|EG002|Reported Event|Placebo|Placebo
10776629|NCT03915470|BG000|Baseline|XF-73|"0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel for a cumulative dose of 6.0 mg of XF-73.~XF-73: XF-73 is a dicationic porphyrin derivative having potent bactericidal properties with a novel mode of action."
10776630|NCT03915470|BG001|Baseline|Placebo|"0.3 mL applications in each naris of placebo to match XF-73 nasal gel.~Placebo: Placebo to match XF-73 nasal gel for colour and viscosity."
10776631|NCT03915470|BG002|Baseline|Total|Total of all reporting groups
10776632|NCT03915470|FG000|Participant Flow|XF-73|Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.
10776633|NCT03915470|FG001|Participant Flow|Placebo|"Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery.~Note: Placebo to match XF-73 nasal gel for colour and viscosity."
10776634|NCT03915470|OG000|Outcome|XF-73|Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.
11193028|NCT02142049|EG003|Reported Event|Part 1: Dose Level 4|"Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 25 mg (PO)~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193029|NCT02142049|EG004|Reported Event|All Subjects Treated at RP2D|"Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R~DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim"
11193030|NCT02142153|BG000|Baseline|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776635|NCT03915470|OG001|Outcome|Placebo|"Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery.~Note: Placebo to match XF-73 nasal gel for colour and viscosity."
10776636|NCT03915470|EG000|Reported Event|XF-73|Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.
10776637|NCT03915470|EG001|Reported Event|Placebo|"Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery.~Note: Placebo to match XF-73 nasal gel for colour and viscosity."
10776638|NCT03892642|BG000|Baseline|BCG + Avelumab|"Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.~Avelumab: Induction phase:~once weekly for weeks 1-6,~once every 2 weeks at week 8, 10, and 12~Maintenance phase:~Once every week for weeks 1-3~Once every 2 weeks starting at week 5, until the next BCG treatment~BCG: Induction phase (cycle 1):~• Once weekly for weeks 1-6~Maintenance phase (Month 3, 6, and 12):~• Once weekly for 3 weeks"
10776639|NCT03892642|FG000|Participant Flow|BCG + Avelumab|"Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.~Avelumab: Induction phase:~once weekly for weeks 1-6,~once every 2 weeks at week 8, 10, and 12~Maintenance phase:~Once every week for weeks 1-3~Once every 2 weeks starting at week 5, until the next BCG treatment~BCG: Induction phase (cycle 1):~• Once weekly for weeks 1-6~Maintenance phase (Month 3, 6, and 12):~• Once weekly for 3 weeks"
10776640|NCT03892642|OG000|Outcome|BCG + Avelumab|"Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.~Avelumab: Induction phase:~once weekly for weeks 1-6,~once every 2 weeks at week 8, 10, and 12~Maintenance phase:~Once every week for weeks 1-3~Once every 2 weeks starting at week 5, until the next BCG treatment~BCG: Induction phase (cycle 1):~• Once weekly for weeks 1-6~Maintenance phase (Month 3, 6, and 12):~• Once weekly for 3 weeks"
10776641|NCT03892642|EG000|Reported Event|BCG + Avelumab|"Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.~Avelumab: Induction phase:~once weekly for weeks 1-6,~once every 2 weeks at week 8, 10, and 12~Maintenance phase:~Once every week for weeks 1-3~Once every 2 weeks starting at week 5, until the next BCG treatment~BCG: Induction phase (cycle 1):~• Once weekly for weeks 1-6~Maintenance phase (Month 3, 6, and 12):~• Once weekly for 3 weeks"
10776642|NCT03881553|BG000|Baseline|Experimental: Premature Infants (NICU)|Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
10776643|NCT03881553|BG001|Baseline|Experimental: Opioid-Exposed Newborns (NICU)|Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
10776644|NCT03881553|BG002|Baseline|Experimental: Hospitalized Infants (PICU)|Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit will participate in up to 2 sessions with NEATCAP intervention and up to to 2 sessions with SVS mattress intervention.
10776645|NCT03881553|BG003|Baseline|Total|Total of all reporting groups
10776646|NCT03881553|FG000|Participant Flow|Premature Infants (NICU)|Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
10776647|NCT03881553|FG001|Participant Flow|Opioid-Exposed Newborns (NICU)|Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
10776648|NCT03881553|FG002|Participant Flow|Hospitalized Infants (PICU)|Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit participated in up to 2 sessions with SVS mattress intervention.
10776649|NCT03881553|OG000|Outcome|Premature Infants (NICU)|"Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention~NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise."
10776650|NCT03881553|OG000|Outcome|Premature Infants (NICU)|"Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention~NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.~."
10776651|NCT03881553|OG000|Outcome|Premature Infants (NICU)|"Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) w participated in 1 session with NEATCAP intervention~NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise."
10776652|NCT03881553|EG000|Reported Event|Premature Infants (NICU): NEATCAP Device|Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) will participated in 1 session with NEATCAP intervention
11193031|NCT02142153|BG001|Baseline|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193032|NCT02142153|BG002|Baseline|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193033|NCT02142153|BG003|Baseline|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776653|NCT03881553|EG001|Reported Event|Opioid-Exposed Newborns (NICU): NEATCAP Device|Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participate in 1 session with NEATCAP intervention.
10776654|NCT03881553|EG002|Reported Event|Hospitalized Infants (PICU): Mattress Device|Infants receiving treatment in the Pediatric Intensive Care participate in up to 2 sessions with SVS mattress intervention.
10776655|NCT03874325|BG000|Baseline|Safety Run In: Durvalumab + Aromatase Inhibitor|"Study terminated early and did not move beyond safety run in.~Participants administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants took standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.~Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.~Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.~Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.~Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted."
10776656|NCT03874325|FG000|Participant Flow|Safety Run In: Durvalumab + Aromatase Inhibitor|"Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.~Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.~Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.~Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.~Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted."
10776657|NCT03874325|FG001|Participant Flow|Expansion: Durvalumab + Aromatase Inhibitor|"Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited.~Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.~Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.~Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.~Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted."
10776658|NCT03874325|OG000|Outcome|Safety Run In: Durvalumab + Aromatase Inhibitor|"Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.~Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.~Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.~Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.~Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted."
10776659|NCT03874325|EG000|Reported Event|Safety Run In: Durvalumab + Aromatase Inhibitor|"Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.~Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.~Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.~Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.~Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted."
10776660|NCT03861611|BG000|Baseline|Ketorolac + Educational Intervention|"Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776661|NCT03861611|BG001|Baseline|Ibuprofen + Educational Intervention|"Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10800875|NCT03894969|BG004|Baseline|Shingrix-Only Group|Subjects belonging to this group were originally randomized to either Sh_NTHi-Mcat_1 Group, Sh_NTHi-Mcat_3 Group or Sh_NTHi-Mcat_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
10800876|NCT03894969|BG005|Baseline|Total|Total of all reporting groups
10776662|NCT03861611|BG002|Baseline|Diclofenac + Educational Intervention|"Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776663|NCT03861611|BG003|Baseline|Total|Total of all reporting groups
10776664|NCT03861611|FG000|Participant Flow|Ketorolac + Educational Intervention|"Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776665|NCT03861611|FG001|Participant Flow|Ibuprofen + Educational Intervention|"Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776666|NCT03861611|FG002|Participant Flow|Diclofenac + Educational Intervention|"Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776667|NCT03861611|OG000|Outcome|Ketorolac + Educational Intervention|"Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776668|NCT03861611|OG001|Outcome|Ibuprofen + Educational Intervention|"Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776669|NCT03861611|OG002|Outcome|Diclofenac + Educational Intervention|"Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776670|NCT03861611|OG000|Outcome|Ketorolac + Educational Intervention|"Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776671|NCT03861611|OG001|Outcome|Ibuprofen + Educational Intervention|"Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776672|NCT03861611|OG002|Outcome|Diclofenac + Educational Intervention|"Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage"
10776673|NCT03861611|EG000|Reported Event|Ketorolac + Educational Intervention|"Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10800877|NCT03894969|FG000|Participant Flow|Sh_NTHi-Mcat_1 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.
10776674|NCT03861611|EG001|Reported Event|Ibuprofen + Educational Intervention|"Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776675|NCT03861611|EG002|Reported Event|Diclofenac + Educational Intervention|"Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.~Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed~Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)"
10776676|NCT03860311|BG000|Baseline|Bladder Ultrasound|"The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.~Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound."
10776677|NCT03860311|BG001|Baseline|Standard of Care|"Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.~Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures."
10776678|NCT03860311|BG002|Baseline|Total|Total of all reporting groups
10776679|NCT03860311|FG000|Participant Flow|Bladder Ultrasound|"The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.~Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound."
10776680|NCT03860311|FG001|Participant Flow|Standard of Care|"Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.~Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures."
10776681|NCT03860311|OG000|Outcome|Bladder Ultrasound|"The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.~Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound."
10776682|NCT03860311|OG001|Outcome|Standard of Care|"Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.~Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures."
10776683|NCT03860311|EG000|Reported Event|Bladder Ultrasound|"The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.~Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound."
10776684|NCT03860311|EG001|Reported Event|Standard of Care|"Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.~Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures."
10800878|NCT03894969|FG001|Participant Flow|Sh_NTHi-Mcat_3 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.
10800879|NCT03894969|FG002|Participant Flow|Sh_NTHi-Mcat_6 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.
10800880|NCT03894969|FG003|Participant Flow|NTHi-Mcat Group|Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.
10776685|NCT03795116|BG000|Baseline|All Participants Group 1|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Group 1 participants received Low dose LED-RL (160 J/cm2) for 30 minutes on one incision site and mock phototherapy for 30 minutes on the other incision site."
10776686|NCT03795116|BG001|Baseline|All Participants Group 2|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Group 2 participants received medium dose LED-RL (320 J/cm2) for 60 minutes on one incision site and mock phototherapy for 60 minutes on the other incision site."
10776687|NCT03795116|BG002|Baseline|All Participants Group 3|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Group 3 participants received high dose LED-RL (480 J/cm2) for 90 minutes on one incision site and mock phototherapy for 90 minutes on the other incision site."
10776688|NCT03795116|BG003|Baseline|Total|Total of all reporting groups
10776689|NCT03795116|FG000|Participant Flow|LED-RL Phototherapy Group 1|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes"
10776690|NCT03795116|FG001|Participant Flow|Mock Irradiation Group 1|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 1: Received mock phototherapy for 30 minutes."
10776691|NCT03795116|FG002|Participant Flow|LED-RL Phototherapy Group 2|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes"
10776692|NCT03795116|FG003|Participant Flow|Mock Irradiation Group 2|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 2: Received mock phototherapy for 60 minutes."
10776693|NCT03795116|FG004|Participant Flow|LED-RL Phototherapy Group 3|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes"
10776694|NCT03795116|FG005|Participant Flow|Mock Irradiation Group 3|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 3: Received mock phototherapy for 90 minutes."
10776695|NCT03795116|OG000|Outcome|LED-RL Phototherapy|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface."
10776696|NCT03795116|OG001|Outcome|Mock Irradiation|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light."
10776697|NCT03795116|OG000|Outcome|LED-RL Phototherapy Group 1|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes"
10776698|NCT03795116|OG001|Outcome|Mock Irradiation Group 1|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 1: Received mock phototherapy for 30 minutes."
11193034|NCT02142153|BG004|Baseline|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776699|NCT03795116|OG002|Outcome|LED-RL Phototherapy Group 2|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes"
10776700|NCT03795116|OG003|Outcome|Mock Irradiation Group 2|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 2: Received mock phototherapy for 60 minutes."
10776701|NCT03795116|OG004|Outcome|LED-RL Phototherapy Group 3|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes"
10776702|NCT03795116|OG005|Outcome|Mock Irradiation Group 3|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 3: Received mock phototherapy for 90 minutes."
10776703|NCT03795116|OG000|Outcome|LED-RL Phototherapy Group 1|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes."
10776704|NCT03795116|OG001|Outcome|Mock Irradiation Group 1|"30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 1: Received mock phototherapy for 30 minutes."
10776705|NCT03795116|OG002|Outcome|LED-RL Phototherapy Group 2|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes."
10776706|NCT03795116|OG003|Outcome|Mock Irradiation Group 2|"30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 2: Received mock phototherapy for 60 minutes."
10776707|NCT03795116|OG004|Outcome|LED-RL Phototherapy Group 3|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes."
10776708|NCT03795116|EG000|Reported Event|LED-RL Phototherapy Group 1|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes."
10776709|NCT03795116|EG001|Reported Event|Mock Irradiation Group 1|"30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 1: Received mock phototherapy for 30 minutes."
10776710|NCT03795116|EG002|Reported Event|LED-RL Phototherapy Group 2|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes."
10776711|NCT03795116|EG003|Reported Event|Mock Irradiation Group 2|"30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 2: Received mock phototherapy for 60 minutes."
11193035|NCT02142153|BG005|Baseline|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193036|NCT02142153|BG006|Baseline|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193037|NCT02142153|BG007|Baseline|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776712|NCT03795116|EG004|Reported Event|LED-RL Phototherapy Group 3|"30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes."
10776713|NCT03795116|EG005|Reported Event|Mock Irradiation Group 3|"Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.~Mock irradiation group 3: Received mock phototherapy for 90 minutes."
10776714|NCT03750292|BG000|Baseline|All Participants|All participants
10776715|NCT03750292|FG000|Participant Flow|Filtration Followed by Placebo|"Participants had a HEPAir X air filter in the home for 8 weeks followed by a 3 week washout period and then a placebo period of 8 weeks where the HEPAirX provided only recirculation without filtration or ventilation using outdoor air.~HEPAirX air filter: It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air."
10776716|NCT03750292|FG001|Participant Flow|Placebo Followed by Filtration|"Participants had a placebo period of 8 weeks where the HEPAirX provided only recirculation without filtration or ventilation using outdoor airfilter in the home followed by a 3 week washout period and then the HEPAirX air filter for 8 weeks.~HEPAirX air filter: It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air."
10776717|NCT03750292|OG000|Outcome|HEPAirX Air Filter|HEPAirX air filter: It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.
10776718|NCT03750292|OG001|Outcome|Control Air Filter|control air filter: A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.
10776719|NCT03750292|EG000|Reported Event|HEPAirX Air Filter|HEPAirX air filter: It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.
10776720|NCT03750292|EG001|Reported Event|Control Air Filter|control air filter: A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.
10776721|NCT03749252|BG000|Baseline|CNS & Body Cohorts 2-6 Years|"Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776722|NCT03749252|BG001|Baseline|CNS & Body Cohorts 7-11 Years|"Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
11339684|NCT03635086|OG000|Outcome|Group D: Two MV-CHIK Liquid Frozen High Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
10776723|NCT03749252|BG002|Baseline|CNS & Body Cohorts 12-17 Years|"Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776724|NCT03749252|BG003|Baseline|Total|Total of all reporting groups
10776725|NCT03749252|FG000|Participant Flow|CNS & Body Cohorts 2-6 Years|"Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776726|NCT03749252|FG001|Participant Flow|CNS & Body Cohorts 7-11 Years|"Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776727|NCT03749252|FG002|Participant Flow|CNS & Body Cohorts 12-17 Years|"Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776728|NCT03749252|OG000|Outcome|CNS Cohort 2-6 Years|"Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776729|NCT03749252|OG001|Outcome|CNS Cohort 7-11 Years|"Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776730|NCT03749252|OG002|Outcome|CNS Cohort 12-17 Years|"Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776731|NCT03749252|EG000|Reported Event|CNS & Body Cohorts 2-6 Years|"Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776732|NCT03749252|EG001|Reported Event|CNS & Body Cohorts 7-11 Years|"Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776733|NCT03749252|EG002|Reported Event|CNS & Body Cohorts 12-17 Years|"Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI~P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection."
10776734|NCT03718000|BG000|Baseline|Control|Participants in this group received no intervention during t he holiday season
10776735|NCT03718000|BG001|Baseline|Daily Self-Weighing (DSW)|"Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season~Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement."
10776736|NCT03718000|BG002|Baseline|Total|Total of all reporting groups
10776737|NCT03718000|FG000|Participant Flow|Control|Participants in this group received no intervention during the holiday season
10776738|NCT03718000|FG001|Participant Flow|Daily Self-Weighing (DSW)|"Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season~Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement."
10776739|NCT03718000|OG000|Outcome|Control|Participants in this group received no intervention during the holiday season
11193038|NCT02142153|BG008|Baseline|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193039|NCT02142153|BG009|Baseline|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776740|NCT03718000|OG001|Outcome|Daily Self-Weighing (DSW)|"Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season~Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement."
10776741|NCT03718000|OG000|Outcome|Control|Participants in this group received no intervention during t he holiday season
10776742|NCT03718000|EG000|Reported Event|Control|Participants in this group received no intervention during the holiday season
10776743|NCT03718000|EG001|Reported Event|Daily Self-Weighing (DSW)|"Participants in this group performed daily self-weighing using digital WiFi scales during the holiday season~Daily self-weighing (DSW): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement."
10776744|NCT03703466|BG000|Baseline|200 mg Abemaciclib With a Meal|200 mg abemaciclib given twice a day (BID) orally with a meal.
10776745|NCT03703466|BG001|Baseline|200 mg Abemaciclib Without a Meal|200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
10776746|NCT03703466|BG002|Baseline|200 mg Abemaciclib Without Regard to Food|200 mg abemaciclib given twice a day (BID) orally without regard for food.
10776747|NCT03703466|BG003|Baseline|Total|Total of all reporting groups
10776748|NCT03703466|FG000|Participant Flow|200 mg Abemaciclib With a Meal|200 mg abemaciclib given twice a day (BID) orally with a meal.
10776749|NCT03703466|FG001|Participant Flow|200 mg Abemaciclib Without a Meal|200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
10776750|NCT03703466|FG002|Participant Flow|200 mg Abemaciclib Without Regard to Food|200 mg abemaciclib given twice a day (BID) orally without regard for food.
10776751|NCT03703466|OG000|Outcome|200 mg Abemaciclib With a Meal|200 mg abemaciclib given twice a day (BID) orally with a meal..
10776752|NCT03703466|OG001|Outcome|200 mg Abemaciclib Without a Meal|200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
10776753|NCT03703466|OG002|Outcome|200 mg Abemaciclib Without Regard to Food|200 mg abemaciclib given twice a day (BID) orally without regard for food.
10776754|NCT03703466|OG000|Outcome|200 mg Abemaciclib With a Meal|200 mg abemaciclib given twice a day (BID) orally with a meal.
10776755|NCT03703466|EG000|Reported Event|200 mg Abemaciclib With a Meal|200 mg abemaciclib given twice a day (BID) orally with a meal.
10776756|NCT03703466|EG001|Reported Event|200 mg Abemaciclib Without a Meal|200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
10776757|NCT03703466|EG002|Reported Event|200 mg Abemaciclib Without Regard to Food|200 mg abemaciclib given twice a day (BID) orally without regard for food.
10776758|NCT03700047|BG000|Baseline|GAL1704 (Needle)|Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
10776759|NCT03700047|BG001|Baseline|GAL1704 (Cannula)|GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
10776760|NCT03700047|BG002|Baseline|Juvederm Voluma|Subjects randomized to control.
10776761|NCT03700047|BG003|Baseline|Total|Total of all reporting groups
10776762|NCT03700047|FG000|Participant Flow|GAL1704 (Needle)|Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
11193040|NCT02142153|BG010|Baseline|Total|Total of all reporting groups
11193041|NCT02142153|FG000|Participant Flow|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776763|NCT03700047|FG001|Participant Flow|GAL1704 (Cannula/Needle)|GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
10776764|NCT03700047|FG002|Participant Flow|Juvederm Voluma|Subjects randomized to control.
10776765|NCT03700047|OG000|Outcome|GAL1704 (Needle)|Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
10776766|NCT03700047|OG001|Outcome|GAL1704 (Cannula/Needle)|GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
10776767|NCT03700047|OG002|Outcome|Juvederm Voluma|Subjects randomized to control.
10776768|NCT03700047|EG000|Reported Event|GAL1704 (Needle)|Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
10776769|NCT03700047|EG001|Reported Event|GAL1704 (Cannula/Needle)|GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
10776770|NCT03700047|EG002|Reported Event|Juvederm Voluma|Subjects randomized to control.
10776771|NCT03698409|BG000|Baseline|Botox in Preservative-free Saline|OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites)
10776772|NCT03698409|BG001|Baseline|Botox in Preserved Saline|"OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites).~Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine."
10776773|NCT03698409|BG002|Baseline|Total|Total of all reporting groups
10776774|NCT03698409|FG000|Participant Flow|Botox in Preservative-free Saline|OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites)
10776775|NCT03698409|FG001|Participant Flow|Botox in Preserved Saline|"OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites).~Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine."
10776776|NCT03698409|OG000|Outcome|Botox in Preservative-free Saline|OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites)
10776777|NCT03698409|OG001|Outcome|Botox in Preserved Saline|"OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites).~Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine."
10776778|NCT03698409|EG000|Reported Event|Botox in Preservative-free Saline|OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative-free saline, as recommended by the manufacturer. 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites)
10776779|NCT03698409|EG001|Reported Event|Botox in Preserved Saline|"OnabotulinumtoxinA (Botox) 200u will be reconstituted using 4 ml of preservative saline (i.e. bacteriostatic saline). 155-195 u of Onabotulinumtoxin A (Botox) will be injected in subjects with chronic migraine, consistent with FDA-approval indications, following the standard injection protocol (31 sites).~Preserved saline in reconstitution of Botox: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine."
10776780|NCT03654651|BG000|Baseline|Evening Peanut Consumption-Evening Snack Sequence|"First intervention:~Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).~Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.~Second Intervention:~Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).~High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine)."
10800881|NCT03894969|FG004|Participant Flow|Shingrix-Only Group|Subjects belonging to this group were originally randomized to either Sh_NTHi-Mcat_1 Group, Sh_NTHi-Mcat_3 Group or Sh_NTHi-Mcat_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
11193042|NCT02142153|FG001|Participant Flow|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193043|NCT02142153|FG002|Participant Flow|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193044|NCT02142153|FG003|Participant Flow|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193045|NCT02142153|FG004|Participant Flow|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193046|NCT02142153|FG005|Participant Flow|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776781|NCT03654651|BG001|Baseline|Evening Snack-Evening Peanut Consumption Sequence|"First Intervention:~Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).~High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).~Second Intervention:~Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).~Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume."
10776782|NCT03654651|BG002|Baseline|Total|Total of all reporting groups
10776783|NCT03654651|FG000|Participant Flow|Evening Peanut Consumption - Evening Snack Sequence|"First intervention:~Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).~Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.~Second intervention:~Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).~High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine)."
10776784|NCT03654651|FG001|Participant Flow|Evening Snack-Evening Peanut Consumption Sequence|"First intervention:~Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).~High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).~Second intervention:~Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).~Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume."
10776785|NCT03654651|OG000|Outcome|Evening Peanut Consumption|Evening Peanut Consumption
10776786|NCT03654651|OG001|Outcome|Evening Lower-fat Higher-carbohydrate Snack|Evening lower-fat higher-carbohydrate snack
10776787|NCT03654651|OG001|Outcome|Evening Lower-Fat Higher-Carbohydrate Snack|Evening Lower-Fat Higher-Carbohydrate Snack
10776788|NCT03654651|EG000|Reported Event|Evening Peanut Consumption|Evening Peanut Consumption
10776789|NCT03654651|EG001|Reported Event|Evening Lower-Fat Higher-Carbohydrate Snack|Evening Lower-Fat Higher-Carbohydrate Snack
10776790|NCT03633396|BG000|Baseline|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
10776791|NCT03633396|BG001|Baseline|Imsidolimab|Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
10776792|NCT03633396|BG002|Baseline|Total|Total of all reporting groups
11193047|NCT02142153|FG006|Participant Flow|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776793|NCT03633396|FG000|Participant Flow|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
10776794|NCT03633396|FG001|Participant Flow|Imsidolimab|Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
11193048|NCT02142153|FG007|Participant Flow|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776795|NCT03633396|OG000|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
10776796|NCT03633396|OG001|Outcome|Imsidolimab|Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
10776797|NCT03633396|EG000|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
10776798|NCT03633396|EG001|Reported Event|Imsidolimab|Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
10776799|NCT03612856|BG000|Baseline|AB023 (Xisomab 3G3)- Dose 1|"Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.~AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023."
11193049|NCT02142153|FG008|Participant Flow|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193050|NCT02142153|FG009|Participant Flow|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193051|NCT02142153|OG000|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776800|NCT03612856|BG001|Baseline|AB023 (Xisomab 3G3)- Dose 2|"Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.~AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023."
10776801|NCT03612856|BG002|Baseline|Placebo|"Participants will receive a single dose of placebo.~placebo: Participants will receive a single dose of placebo."
10776802|NCT03612856|BG003|Baseline|Total|Total of all reporting groups
10776803|NCT03612856|FG000|Participant Flow|AB023 (Xisomab 3G3)- Dose 1|"Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.~AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023."
11193052|NCT02142153|OG001|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193053|NCT02142153|OG002|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193054|NCT02142153|OG003|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776804|NCT03612856|FG001|Participant Flow|AB023 (Xisomab 3G3)- Dose 2|"Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.~AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023."
10776805|NCT03612856|FG002|Participant Flow|Placebo|"Participants will receive a single dose of placebo.~placebo: Participants will receive a single dose of placebo."
10776806|NCT03612856|OG000|Outcome|AB023 (Xisomab 3G3)- Dose 1|"Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.~AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023."
10776807|NCT03612856|OG001|Outcome|AB023 (Xisomab 3G3)- Dose 2|"Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.~AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023."
10776808|NCT03612856|OG002|Outcome|Placebo|"Participants will receive a single dose of placebo.~placebo: Participants will receive a single dose of placebo."
10776809|NCT03612856|EG000|Reported Event|AB023 (Xisomab 3G3)- Dose 1|"Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.~AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023."
10776810|NCT03612856|EG001|Reported Event|AB023 (Xisomab 3G3)- Dose 2|"Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.~AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023."
10776811|NCT03612856|EG002|Reported Event|Placebo|"Participants will receive a single dose of placebo.~placebo: Participants will receive a single dose of placebo."
10776812|NCT03607994|BG000|Baseline|HIRREM-SOP (BCC)|"Acoustic stimulation linked to brainwave activity and continued current care.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time."
11193055|NCT02142153|OG004|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776813|NCT03607994|BG001|Baseline|Nonspecific Acoustic Stimulation (NCC)|"Continued current care and acoustic stimulation that is not linked to brainwave activity.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.~NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity."
10776814|NCT03607994|BG002|Baseline|Total|Total of all reporting groups
10776815|NCT03607994|FG000|Participant Flow|HIRREM-SOP (BCC)|"Acoustic stimulation linked to brainwave activity and continued current care.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time."
10776816|NCT03607994|FG001|Participant Flow|Nonspecific Acoustic Stimulation (NCC)|"Continued current care and acoustic stimulation that is not linked to brainwave activity.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.~NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity."
10776817|NCT03607994|OG000|Outcome|HIRREM-SOP (BCC)|"Acoustic stimulation linked to brainwave activity and continued current care.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time."
10776818|NCT03607994|OG001|Outcome|Nonspecific Acoustic Stimulation (NCC)|"Continued current care and acoustic stimulation that is not linked to brainwave activity.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.~NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity."
10776819|NCT03607994|EG000|Reported Event|HIRREM-SOP (BCC)|"Acoustic stimulation linked to brainwave activity and continued current care.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time."
10776820|NCT03607994|EG001|Reported Event|Nonspecific Acoustic Stimulation (NCC)|"Continued current care and acoustic stimulation that is not linked to brainwave activity.~HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.~NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity."
10776821|NCT03602560|BG000|Baseline|Seladelpar 5-10 mg|seladelpar 5-10 mg: Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study
10776822|NCT03602560|BG001|Baseline|Seladelpar 10 mg|seladelpar 10 mg: Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
11193056|NCT02142153|OG005|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193057|NCT02142153|OG006|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193058|NCT02142153|OG007|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776823|NCT03602560|BG002|Baseline|Placebo|Placebo: One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
10776824|NCT03602560|BG003|Baseline|Total|Total of all reporting groups
10776825|NCT03602560|FG000|Participant Flow|Seladelpar 5-10 mg|seladelpar 5-10 mg: Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
10776826|NCT03602560|FG001|Participant Flow|Seladelpar 10 mg|seladelpar 10 mg: Seladelpar 10 mg for double-blind period.
10776827|NCT03602560|FG002|Participant Flow|Placebo|Placebo: One capsule daily for double-blind period.
10776828|NCT03602560|OG000|Outcome|Seladelpar 5-10 mg|seladelpar 5-10 mg: Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
10776829|NCT03602560|OG001|Outcome|Seladelpar 10 mg|seladelpar 10 mg: Seladelpar 10 mg for double-blind period.
10776830|NCT03602560|OG002|Outcome|Placebo|Placebo: One capsule daily for double-blind period.
10776831|NCT03602560|EG000|Reported Event|Seladelpar 5/10 mg|Seladelpar 5/10 mg in this double-blinded study
10776832|NCT03602560|EG001|Reported Event|Seladelpar 10 mg|Seladelpar 10 mg in this double-blinded study
11193059|NCT02142153|OG008|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776833|NCT03602560|EG002|Reported Event|Placebo|Placebo in this double-blinded study
10776834|NCT03589469|BG000|Baseline|Loncastuximab Tesirine|Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
10776835|NCT03589469|FG000|Participant Flow|Loncastuximab Tesirine|Participants received loncastuximab tesirine as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg once every 3 weeks (Q3W) for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
10776836|NCT03589469|OG000|Outcome|Loncastuximab Tesirine|Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
10776837|NCT03589469|EG000|Reported Event|Loncastuximab Tesirine|Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
10800882|NCT03894969|OG000|Outcome|Sh_NTHi-Mcat_1 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.
10800883|NCT03894969|OG001|Outcome|NTHi-Mcat Group|Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.
10800884|NCT03894969|OG001|Outcome|Sh_NTHi-Mcat_3 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.
10800885|NCT03894969|OG002|Outcome|Sh_NTHi-Mcat_6 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.
10800886|NCT03894969|OG003|Outcome|NTHi-Mcat Group|Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.
10800887|NCT03894969|OG004|Outcome|Shingrix-Only Group|Subjects belonging to this group were originally randomized to either Sh_NTHi-Mcat_1 Group, Sh_NTHi-Mcat_3 Group or Sh_NTHi-Mcat_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
10800888|NCT03894969|OG004|Outcome|Shingrix-Only Group|Subjects enrolled in this group received at least 1, maximum 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, but didn't receive any dose of NTHI Mcat investigational vaccine.
10800889|NCT03894969|EG000|Reported Event|Sh_NTHi-Mcat_1 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.
10800890|NCT03894969|EG001|Reported Event|Sh_NTHi-Mcat_3 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.
10800891|NCT03894969|EG002|Reported Event|Sh_NTHi-Mcat_6 Group|Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.
10800892|NCT03894969|EG003|Reported Event|NTHi-Mcat Group|Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.
10800893|NCT03894969|EG004|Reported Event|Shingrix-Only Group|Subjects belonging to this group were originally randomized to either Sh_NTHi-Mcat_1 Group, Sh_NTHi-Mcat_3 Group or Sh_NTHi-Mcat_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
11193060|NCT02142153|OG009|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776838|NCT03563716|BG000|Baseline|Placebo + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776839|NCT03563716|BG001|Baseline|Tiragolumab + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776840|NCT03563716|BG002|Baseline|Total|Total of all reporting groups
10776841|NCT03563716|FG000|Participant Flow|Placebo + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776842|NCT03563716|FG001|Participant Flow|Tiragolumab + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10964283|NCT00876460|EG007|Reported Event|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
11193061|NCT02142153|OG000|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
11193062|NCT02142153|OG001|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically significant safety lab and ECG abnormalities No clinically significant findings"
11193063|NCT02142153|OG002|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
11193064|NCT02142153|OG003|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
11193065|NCT02142153|OG004|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
11193066|NCT02142153|OG005|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
11193067|NCT02142153|OG006|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
11193068|NCT02142153|OG007|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
10776843|NCT03563716|OG000|Outcome|Placebo + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776844|NCT03563716|OG001|Outcome|Tiragolumab + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776845|NCT03563716|EG000|Reported Event|Placebo + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776846|NCT03563716|EG001|Reported Event|Tiragolumab + Atezolizumab|Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
10776847|NCT03505671|BG000|Baseline|Group 1 (Acupuncture)|"Participants undergo 8 45-minute acupuncture treatments over 10 weeks.~Acupuncture Therapy: Undergo acupuncture therapy~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776848|NCT03505671|BG001|Baseline|Group 2 (Usual Care)|"Participants receive usual care.~Best Practice: Receive usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776849|NCT03505671|BG002|Baseline|Total|Total of all reporting groups
10776850|NCT03505671|FG000|Participant Flow|Group 1 (Acupuncture)|"Participants undergo 8 45-minute acupuncture treatments over 10 weeks.~Acupuncture Therapy: Undergo acupuncture therapy~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776851|NCT03505671|FG001|Participant Flow|Group 2 (Usual Care)|"Participants receive usual care.~Best Practice: Receive usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776852|NCT03505671|OG000|Outcome|Group 1 (Acupuncture)|"Participants undergo 8 45-minute acupuncture treatments over 10 weeks.~Acupuncture Therapy: Undergo acupuncture therapy~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11193069|NCT02142153|OG008|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
11193070|NCT02142153|OG009|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
11193071|NCT02142153|EG000|Reported Event|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193072|NCT02142153|EG001|Reported Event|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193073|NCT02142153|EG002|Reported Event|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193074|NCT02142153|EG003|Reported Event|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
10776853|NCT03505671|OG001|Outcome|Group 2 (Usual Care)|"Participants receive usual care.~Best Practice: Receive usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776854|NCT03505671|EG000|Reported Event|Group 1 (Acupuncture)|"Participants undergo 8 45-minute acupuncture treatments over 10 weeks.~Acupuncture Therapy: Undergo acupuncture therapy~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776855|NCT03505671|EG001|Reported Event|Group 2 (Usual Care)|"Participants receive usual care.~Best Practice: Receive usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10776856|NCT03469999|BG000|Baseline|Dysport Injectable Product|"All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.~Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session."
10776857|NCT03469999|FG000|Participant Flow|Dysport Injectable Product|"All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.~Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session."
10776858|NCT03469999|OG000|Outcome|Dysport Injectable Product|"All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.~Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session."
10776859|NCT03469999|OG000|Outcome|Dysport Injectable Product|"All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.~Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.~Data was not analyzed"
10776860|NCT03469999|EG000|Reported Event|Dysport Injectable Product|"All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.~Dysport Injectable Product: All participants will receive Dysport injection at multi levels in the spastic lower limb(s)."
10776861|NCT03463993|BG000|Baseline|Group A|"Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.~Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776862|NCT03463993|BG001|Baseline|Group B|"Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776863|NCT03463993|BG002|Baseline|Total|Total of all reporting groups
10776864|NCT03463993|FG000|Participant Flow|Group A|"Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.~Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776865|NCT03463993|FG001|Participant Flow|Group B|"Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10800894|NCT03523273|BG000|Baseline|Liraglutide|Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800895|NCT03523273|BG001|Baseline|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800896|NCT03523273|BG002|Baseline|Total|Total of all reporting groups
10776866|NCT03463993|OG000|Outcome|Group A|"Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.~Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776867|NCT03463993|OG001|Outcome|Group B|"Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776868|NCT03463993|EG000|Reported Event|Group A|"Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.~Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776869|NCT03463993|EG001|Reported Event|Group B|"Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby~Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section."
10776870|NCT03390101|BG000|Baseline|BCD-085 Q2W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50.~BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."
10776871|NCT03390101|BG001|Baseline|BCD-085 Q4W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50.~BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54."
10776872|NCT03390101|BG002|Baseline|Placebo|"Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50.~Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."
10964284|NCT00876694|BG000|Baseline|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
11193075|NCT02142153|EG004|Reported Event|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776873|NCT03390101|BG003|Baseline|Total|Total of all reporting groups
10776874|NCT03390101|FG000|Participant Flow|BCD-085 Q2W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50.~BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."
10800897|NCT03523273|FG000|Participant Flow|Liraglutide|Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10776875|NCT03390101|FG001|Participant Flow|BCD-085 Q4W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50.~BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54."
10776876|NCT03390101|FG002|Participant Flow|Placebo|"Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50.~Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."
10776877|NCT03390101|OG000|Outcome|BCD-085 Q2W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50.~BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."
10776878|NCT03390101|OG001|Outcome|BCD-085 Q4W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50.~BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54."
10776879|NCT03390101|OG002|Outcome|Placebo|"Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50.~Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."
10776880|NCT03390101|EG000|Reported Event|BCD-085 Q2W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50.~BCD-085 Q2W: In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."
10800898|NCT03523273|FG001|Participant Flow|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10964285|NCT00876694|BG001|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
11193076|NCT02142153|EG005|Reported Event|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193077|NCT02142153|EG006|Reported Event|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
11193078|NCT02142153|EG007|Reported Event|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193079|NCT02142153|EG008|Reported Event|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
10776881|NCT03390101|EG001|Reported Event|BCD-085 Q4W|"Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50.~BCD-085 Q4W: In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54."
10776882|NCT03390101|EG002|Reported Event|Placebo|"Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50.~Placebo: In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."
11193080|NCT02142153|EG009|Reported Event|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
11193081|NCT02142283|BG000|Baseline|Trevo Thrombectomy Procedure|"Trevo Thrombectomy Procedure and Medical Management~Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193082|NCT02142283|BG001|Baseline|Medical Management|"Medical Management~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193083|NCT02142283|BG002|Baseline|Total|Total of all reporting groups
11193084|NCT02142283|FG000|Participant Flow|Trevo Thrombectomy Procedure|"Trevo Thrombectomy Procedure and Medical Management~Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193085|NCT02142283|FG001|Participant Flow|Medical Management|"Medical Management~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
10776892|NCT03213158|BG000|Baseline|Highly Sensitized Kidney Transplant Candidates|"The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin.~Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles."
10800899|NCT03523273|OG000|Outcome|Liraglutide|Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800900|NCT03523273|OG001|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800901|NCT03523273|EG000|Reported Event|Liraglutide|Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800902|NCT03523273|EG001|Reported Event|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
10800903|NCT03464136|BG000|Baseline|Adalimumab|Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
10800904|NCT03464136|BG001|Baseline|Ustekinumab|Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.
10800905|NCT03464136|BG002|Baseline|Total|Total of all reporting groups
10800906|NCT03464136|FG000|Participant Flow|Adalimumab|Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
10800907|NCT03464136|FG001|Participant Flow|Ustekinumab|Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.
10776893|NCT03213158|FG000|Participant Flow|Highly Sensitized Kidney Transplant Candidates|"The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin.~Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles."
10776894|NCT03213158|OG000|Outcome|Highly Sensitized Kidney Transplant Candidates|"The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin.~Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles."
10776895|NCT03213158|EG000|Reported Event|Highly Sensitized Kidney Transplant Candidates|"The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin.~Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles."
10776896|NCT03194646|BG000|Baseline|Vilaprisan 2 mg A1 (3/1 Regimen)|4 treatment periods of 12 weeks, each separated by 1 bleeding episode
10776897|NCT03194646|BG001|Baseline|Vilaprisan 2 mg A2 (6/2 Regimen)|2 treatment periods of 24 weeks, separated by 2 bleeding episodes
10776898|NCT03194646|BG002|Baseline|Vilaprisan 2 mg A3 (3/2 Regimen)|3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
10776899|NCT03194646|BG003|Baseline|B (Standard of Care)|Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
10776900|NCT03194646|BG004|Baseline|Total|Total of all reporting groups
10776901|NCT03194646|FG000|Participant Flow|Vilaprisan 2 mg A1 (3/1 Regimen)|4 treatment periods of 12 weeks, each separated by 1 bleeding episode
10776902|NCT03194646|FG001|Participant Flow|Vilaprisan 2 mg A2 (6/2 Regimen)|2 treatment periods of 24 weeks, separated by 2 bleeding episodes
10776903|NCT03194646|FG002|Participant Flow|Vilaprisan 2 mg A3 (3/2 Regimen)|3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
10776904|NCT03194646|FG003|Participant Flow|B (Standard of Care)|Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
10776905|NCT03194646|OG000|Outcome|Vilaprisan 2 mg A1 (3/1 Regimen)|4 treatment periods of 12 weeks, each separated by 1 bleeding episode
11240897|NCT02482675|FG015|Participant Flow|Whey Protein, Then Sodium Caseinate, Then Milk, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
10776906|NCT03194646|OG001|Outcome|Vilaprisan 2 mg A2 (6/2 Regimen)|2 treatment periods of 24 weeks, separated by 2 bleeding episodes
10776907|NCT03194646|OG002|Outcome|Vilaprisan 2 mg A3 (3/2 Regimen)|3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
10776908|NCT03194646|OG003|Outcome|B (Standard of Care)|Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
10776909|NCT03194646|OG000|Outcome|Vilaprisan 2 mg A1 (3/1 Regimen)|4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
10776910|NCT03194646|EG000|Reported Event|Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs|4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
10776911|NCT03194646|EG001|Reported Event|Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs|2 treatment periods of 24 weeks, separated by 2 bleeding episodes
10776912|NCT03194646|EG002|Reported Event|Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs|3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
10776913|NCT03194646|EG003|Reported Event|Standard of Care B - Treatment Emergent AEs|Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
10776914|NCT03194646|EG004|Reported Event|Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs|4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
10776915|NCT03194646|EG005|Reported Event|Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs|2 treatment periods of 24 weeks, separated by 2 bleeding episodes
10964286|NCT00876694|BG002|Baseline|Total|Total of all reporting groups
10776916|NCT03194646|EG006|Reported Event|Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs|3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
10776917|NCT03194646|EG007|Reported Event|Standard of Care B - Post Treatment AEs|Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
10776918|NCT03179605|BG000|Baseline|DFD-06 Cream|"This is a single arm, open label study and there will be no reference or control product used in this study~DFD06: Apply twice per day for 15 days"
10776919|NCT03179605|FG000|Participant Flow|DFD-06 Cream|"This is a single arm, open label study and there will be no reference or control product used in this study~DFD06: Apply twice per day for 15 days"
10776920|NCT03179605|OG000|Outcome|DFD-06 Cream|"This is a single arm, open label study and there will be no reference or control product used in this study~DFD06: Apply twice per day for 15 days"
10776921|NCT03179605|EG000|Reported Event|DFD-06 Cream|"This is a single arm, open label study and there will be no reference or control product used in this study~DFD06: Apply twice per day for 15 days"
10776922|NCT03159195|BG000|Baseline|Palbociclib + Aromatase Inhibitor (P+AI)|Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776923|NCT03159195|BG001|Baseline|Palbociclib + Fulvestrant (P+FV)|Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776924|NCT03159195|BG002|Baseline|Total|Total of all reporting groups
10776925|NCT03159195|FG000|Participant Flow|Palbociclib + Aromatase Inhibitor (AI) (P+AI)|Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776926|NCT03159195|FG001|Participant Flow|Palbociclib + Fulvestrant (P+FV)|Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776927|NCT03159195|OG000|Outcome|Palbociclib + Aromatase Inhibitor (P+AI)|Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776928|NCT03159195|OG001|Outcome|Palbociclib + Fulvestrant (P+FV)|Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776929|NCT03159195|EG000|Reported Event|Palbociclib + Aromatase Inhibitor (P+AI)|Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10776930|NCT03159195|EG001|Reported Event|Palbociclib + Fulvestrant (P+FV)|Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
10800908|NCT03464136|OG000|Outcome|Adalimumab|Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
10800909|NCT03464136|OG001|Outcome|Ustekinumab|Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.
10964287|NCT00876694|FG000|Participant Flow|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
10964288|NCT00876694|FG001|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
11339685|NCT03635086|EG000|Reported Event|Group A: Two MV-CHIK Lyophilized Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
10800910|NCT03464136|EG000|Reported Event|Adalimumab|Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
10800911|NCT03464136|EG001|Reported Event|Ustekinumab|Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.
10800912|NCT03338816|BG000|Baseline|Placebo|Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months during the OLE period.
10800913|NCT03338816|BG001|Baseline|Givosiran|Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months during the OLE Period.
10800914|NCT03338816|BG002|Baseline|Total|Total of all reporting groups
10800915|NCT03338816|FG000|Participant Flow|Placebo 6-Month DB|Matching placebo (normal saline [0.9% NaCl]) was administered subcutaneously (SC), monthly (QM), for 6 months during the 6-Month Double-blind (DB) Period.
10800916|NCT03338816|FG001|Participant Flow|Givosiran 2.5 mg/kg 6-Month DB|Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
10800917|NCT03338816|FG002|Participant Flow|Placebo/Givosiran|Patients who received placebo during the 6-Month DB Period then entered the Open-Label Extension (OLE) Period and were administered givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months. Upon implementation of protocol Amendment 5, active patients receiving 1.25 mg/kg givosiran once monthly in the OLE had their dose increased to 2.5 mg/kg givosiran once monthly.
10800918|NCT03338816|FG003|Participant Flow|Givosiran/Givosiran|Patients who received givosiran during the 6-Month DB Period then entered the OLE Period and were administered givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM mg/kg for 29 months. Upon implementation of protocol Amendment 5, active patients receiving 1.25 mg/kg givosiran once monthly in the OLE had their dose increased to 2.5 mg/kg givosiran once monthly.
10800919|NCT03338816|OG000|Outcome|Placebo|Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
10800920|NCT03338816|OG001|Outcome|Givosiran 2.5 mg/kg|Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
10800921|NCT03338816|EG000|Reported Event|Placebo 6-Month DB|Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
10800922|NCT03338816|EG001|Reported Event|Givosiran 2.5 mg/kg 6-Month DB|Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
10776931|NCT03150862|BG000|Baseline|Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks|Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
10776932|NCT03150862|BG001|Baseline|Arm A: DE-Pamiparib 4 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
10776933|NCT03150862|BG002|Baseline|Arm A: DE- Pamiparib 6Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776934|NCT03150862|BG003|Baseline|Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776935|NCT03150862|BG004|Baseline|Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
10776936|NCT03150862|BG005|Baseline|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776937|NCT03150862|BG006|Baseline|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776938|NCT03150862|BG007|Baseline|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776939|NCT03150862|BG008|Baseline|Total|Total of all reporting groups
10776940|NCT03150862|FG000|Participant Flow|Arm A: Dose Escalation (DE) - Pamiparib 2 Weeks (Wks) + Radiation Therapy (RT) 6 Wks|Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 milligrams (mg) pamiparib orally twice daily (BID) for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
11193086|NCT02142283|OG000|Outcome|Trevo Thrombectomy Procedure|"Trevo Thrombectomy Procedure and Medical Management~Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
10776941|NCT03150862|FG001|Participant Flow|Arm A: DE-Pamiparib 4 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
10776942|NCT03150862|FG002|Participant Flow|Arm A: DE- Pamiparib 6Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776943|NCT03150862|FG003|Participant Flow|Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776944|NCT03150862|FG004|Participant Flow|Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
10776945|NCT03150862|FG005|Participant Flow|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776946|NCT03150862|FG006|Participant Flow|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776947|NCT03150862|FG007|Participant Flow|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776948|NCT03150862|OG000|Outcome|Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks|Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
10776949|NCT03150862|OG001|Outcome|Arm A: DE-Pamiparib 4 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
10776950|NCT03150862|OG002|Outcome|Arm A: DE- Pamiparib 6Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776951|NCT03150862|OG003|Outcome|Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
10776952|NCT03150862|OG004|Outcome|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776953|NCT03150862|OG005|Outcome|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776954|NCT03150862|OG000|Outcome|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776955|NCT03150862|OG001|Outcome|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776956|NCT03150862|OG000|Outcome|Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776957|NCT03150862|OG000|Outcome|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776958|NCT03150862|OG003|Outcome|Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776959|NCT03150862|OG004|Outcome|Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
10776960|NCT03150862|OG005|Outcome|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776961|NCT03150862|OG006|Outcome|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776962|NCT03150862|OG007|Outcome|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776963|NCT03150862|OG000|Outcome|Arm C: DE- Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776964|NCT03150862|OG001|Outcome|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776965|NCT03150862|EG000|Reported Event|Arm 1Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks|Participants with newly diagnosed unmethylated glioblastoma (GBM) received 60 mg pamiparib orally BID for 2 weeks in combination with up to 60 Gy radiation for 6 weeks
10776966|NCT03150862|EG001|Reported Event|Arm A: DE-Pamiparib 4 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 4 weeks in combination with up to 60 Gy radiation for 6 weeks
10776967|NCT03150862|EG002|Reported Event|Arm A: DE- Pamiparib 6Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776968|NCT03150862|EG003|Reported Event|Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks
10776969|NCT03150862|EG004|Reported Event|Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide|Participants with newly diagnosed unmethylated GBM received 60 mg pamiparib orally for 6 weeks in combination with up to 60 Gy radiation for 6 weeks and 60 mg temozolomide Wks 1 and 5
10776970|NCT03150862|EG005|Reported Event|Arm C: DE - Pamiparib + Temozolomide 20 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 20 mg temozolomide once daily orally from Day 1 to Day 21
10776971|NCT03150862|EG006|Reported Event|Arm C: DE - Pamiparib + Temozolomide 40 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 40 mg temozolomide once daily orally from Day 1 to Day 21
10776972|NCT03150862|EG007|Reported Event|Arm C: E- Pamiparib + Temozolomide 60 mg|Participants with both methylated and unmethylated recurrent/refractory GBM received 60 mg pamiparib BID and 60 mg temozolomide once daily orally from Day 1 to Day 7
10776973|NCT03074695|BG000|Baseline|Dural Puncture Epidural (DPE)|"Women who have analgesia initiated with a DPE technique~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776974|NCT03074695|BG001|Baseline|Standard Epidural (EPL)|"Women who have analgesia initiated with an epidural technique~Standard Epidural (EPL): Standard epidural placement~Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776975|NCT03074695|BG002|Baseline|Total|Total of all reporting groups
10776976|NCT03074695|FG000|Participant Flow|Dural Puncture Epidural (DPE)|"Women who have analgesia initiated with a DPE technique~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776977|NCT03074695|FG001|Participant Flow|Standard Epidural (EPL)|"Women who have analgesia initiated with an epidural technique~Standard Epidural (EPL): Standard epidural placement~Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776978|NCT03074695|OG000|Outcome|Dural Puncture Epidural (DPE)|"Women who have analgesia initiated with a DPE technique~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776979|NCT03074695|OG001|Outcome|Standard Epidural (EPL)|"Women who have analgesia initiated with an epidural technique~Standard Epidural (EPL): Standard epidural placement~Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776980|NCT03074695|EG000|Reported Event|Dural Puncture Epidural (DPE)|"Women who have analgesia initiated with a DPE technique~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing~Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776981|NCT03074695|EG001|Reported Event|Standard Epidural (EPL)|"Women who have analgesia initiated with an epidural technique~Standard Epidural (EPL): Standard epidural placement~Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL."
10776982|NCT03052608|BG000|Baseline|Lorlatinib|Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10964289|NCT00876694|OG000|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
10776983|NCT03052608|BG001|Baseline|Crizotinib|Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
11193087|NCT02142283|OG001|Outcome|Medical Management|"Medical Management~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193088|NCT02142283|EG000|Reported Event|Trevo Thrombectomy Procedure|"Trevo Thrombectomy Procedure and Medical Management~Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193089|NCT02142283|EG001|Reported Event|Medical Management|"Medical Management~Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc"
11193090|NCT02142361|BG000|Baseline|Overall Study Group|All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
11193091|NCT02142361|FG000|Participant Flow|Omafilcon A/Enfilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193092|NCT02142361|FG001|Participant Flow|Ocufilcon D/Enfilcon A|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193093|NCT02142361|FG002|Participant Flow|Methafilcon B/Enfilcon A|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193094|NCT02142361|OG000|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193095|NCT02142361|OG001|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193096|NCT02142361|OG002|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
11193097|NCT02142361|OG000|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at 1 week.
11193098|NCT02142361|OG001|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
11193099|NCT02142361|OG000|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
11193100|NCT02142361|EG000|Reported Event|Omafilcon A|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
11193101|NCT02142361|EG001|Reported Event|Ocufilcon D|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
10776984|NCT03052608|BG002|Baseline|Total|Total of all reporting groups
10964290|NCT00876694|OG001|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
11193102|NCT02142361|EG002|Reported Event|Methafilcon B|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
11193103|NCT02142387|BG000|Baseline|Districts Which Implement New DA-BLS Training Program|A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly.
11193104|NCT02142387|BG001|Baseline|Districts Which Keep Current BLS Training Program|A one-hour training program that was developed by the Korea CDC and it was based on the AHA guideline (http://www.cdc.go.kr/board.es?mid=a20503050000&bid=0021&tag=&act=view&list_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
11193105|NCT02142387|BG002|Baseline|Total|Total of all reporting groups
11202196|NCT02205983|OG001|Outcome|4 mg Hydromphone|"Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion~4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task."
11193106|NCT02142387|FG000|Participant Flow|New DA-BLS Training Program|A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation.
10776985|NCT03052608|FG000|Participant Flow|Lorlatinib|Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776986|NCT03052608|FG001|Participant Flow|Crizotinib|Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776987|NCT03052608|OG000|Outcome|Lorlatinib|Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776988|NCT03052608|OG001|Outcome|Crizotinib|Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776989|NCT03052608|EG000|Reported Event|Lorlatinib|Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776990|NCT03052608|EG001|Reported Event|Crizotinib|Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
10776991|NCT02944071|BG000|Baseline|Ranger DCB|"The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.~Multiple interventions:~Prior to or during Index Procedure:~Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed~Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed~Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.~Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter"
10776992|NCT02944071|FG000|Participant Flow|Ranger DCB|"The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.~Multiple interventions:~Prior to or during Index Procedure:~Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed~Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed~Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.~Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter"
10964291|NCT00876694|EG000|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
11193107|NCT02142387|FG001|Participant Flow|Current Basic Life Support (BLS) Training Program|A one-hour training program that was developed by the Korea Center for Disease and Prevention (CDC) and it was based on the American Heart Association (AHA) guideline (http://www.cdc.go.kr/board.es?mid=a20503050000&bid=0021&tag=&act=view&list_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
11193108|NCT02142387|OG000|Outcome|Districts Which Implement Newer DA-BLS Training Program|"the out of hospital cardiac arrest victims who were given bystander CPR by whom trained as newer dispatcher-assisted BLS training program, which more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.~BLS CPR program with dispatcher assisted CPR simulation: the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice."
10776993|NCT02944071|OG000|Outcome|Ranger DCB|"The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.~Multiple interventions:~Prior to or during Index Procedure:~Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed~Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed~Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.~Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter"
10776994|NCT02944071|EG000|Reported Event|(Ranger & Ranger LE) and Ranger DCB|"The working length is 80cm and 135cm for Ranger DCB catheter and 90 cm and 150cm for Ranger SL and Ranger LE DCB catheter.~Multiple interventions:~Prior to or during Index Procedure:~Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of ipsilateral iliac inflow lesions may be performed~Prior to treatment of the index limb, successful treatment of the arteries of the non-index limb may be performed~Prior to treatment of the index limb, absence of clinical complications such as embolism, thrombosis, severe dissection, vessel rupture must be confirmed.~Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter"
10776995|NCT02938520|BG000|Baseline|CAB LA + RPV LA (Q4W)|Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.
10776996|NCT02938520|BG001|Baseline|ABC/ DTG/ 3TC|During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
10776997|NCT02938520|BG002|Baseline|Total|Total of all reporting groups
10776998|NCT02938520|FG000|Participant Flow|CAB LA + RPV LA (Q4W)|Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.
10776999|NCT02938520|FG001|Participant Flow|ABC/ DTG/ 3TC|During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
10777000|NCT02938520|OG000|Outcome|CAB LA + RPV LA (Q4W)|Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.
10777001|NCT02938520|OG001|Outcome|ABC/ DTG/ 3TC|During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
10777002|NCT02938520|OG000|Outcome|CAB LA|Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100.
10777003|NCT02938520|OG000|Outcome|RPV LA|Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100.
10777004|NCT02938520|OG001|Outcome|RPV LA|Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100.
10777005|NCT02938520|EG000|Reported Event|CAB LA+RPV LA (Q4W)|Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period.
10964292|NCT00876694|EG001|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
10777006|NCT02938520|EG001|Reported Event|ABC/ DTG/ 3TC|During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
10777007|NCT02922725|BG000|Baseline|Depressed Patients Receiving Study Drug|"Participants diagnosed with MDD~5-hydroxytryptophan and Creatine"
10777008|NCT02922725|BG001|Baseline|Depressed Patients Receiving Placebo|"Participants diagnosed with MDD~Placebo control"
10777009|NCT02922725|BG002|Baseline|Healthy Controls|"Participants with no history of MDD~No intervention"
10777010|NCT02922725|BG003|Baseline|Total|Total of all reporting groups
10777011|NCT02922725|FG000|Participant Flow|Depressed Patients Receiving Study Drug|"Participants diagnosed with MDD~5-hydroxytryptophan 100mg PO BID and Creatine monohydrate 5g PO Qday"
10777012|NCT02922725|FG001|Participant Flow|Depressed Patients Receiving Placebo|"Participants diagnosed with MDD~Placebo control (fructose 100mg PO BID and fructose 5g PO Qday)"
10777013|NCT02922725|FG002|Participant Flow|No Intervention: Healthy Controls|Healthy controls (no history of depression) recruited for neuroimaging comparison group
10777014|NCT02922725|OG000|Outcome|Depressed Patients Receiving Study Drug|"Participants diagnosed with MDD~5-hydroxytryptophan and Creatine"
10777015|NCT02922725|OG001|Outcome|Depressed Patients Receiving Placebo|"Participants diagnosed with MDD~Placebo control"
10777016|NCT02922725|EG000|Reported Event|Depressed Patients Receiving Study Drug|"Participants diagnosed with MDD~5-hydroxytryptophan and Creatine"
10964293|NCT00876733|BG000|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
11193109|NCT02142387|OG001|Outcome|Districts Which Keep Traditional BLS Training Program|Control group commonly uses a one-hour training program which was developed by the Korea CDC. It focuses on detailed techniques of performing high-quality chest compressions.
10777017|NCT02922725|EG001|Reported Event|Depressed Patients Receiving Placebo|"Participants diagnosed with MDD~Placebo control"
10777018|NCT02922725|EG002|Reported Event|Health Controls|"Participants with no history of MDD~No intervention"
10777019|NCT02886572|BG000|Baseline|Stereotactic Radiosurgery|"All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014~Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery"
10777020|NCT02886572|FG000|Participant Flow|Stereotactic Radiosurgery|"All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014~Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery"
10777021|NCT02886572|OG000|Outcome|Stereotactic Radiosurgery|"All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014~Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery"
10777022|NCT02886572|EG000|Reported Event|Stereotactic Radiosurgery|"All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014~Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery"
10777023|NCT02831673|BG000|Baseline|DTG + 3TC|Participants received a two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) once daily for 48 weeks.
10777024|NCT02831673|BG001|Baseline|DTG + TDF/FTC|Participants received a three-drug regimen of dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) fixed dose combination (FDC) once daily for 48 weeks.
10777025|NCT02831673|BG002|Baseline|Total|Total of all reporting groups
10777026|NCT02831673|FG000|Participant Flow|DTG + 3TC|Participants received a two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) once daily for 48 weeks.
10777027|NCT02831673|FG001|Participant Flow|DTG + TDF/FTC|Participants received a three-drug regimen of dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) fixed dose combination (FDC) once daily for 48 weeks.
10777028|NCT02831673|OG000|Outcome|DTG + 3TC|Participants received a two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) once daily for 48 weeks.
10777029|NCT02831673|OG001|Outcome|DTG + TDF/FTC|Participants received a three-drug regimen of dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) fixed dose combination (FDC) once daily for 48 weeks.
10777030|NCT02831673|EG000|Reported Event|DTG + 3TC|Participants received a two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) once daily for 48 weeks.
10777031|NCT02831673|EG001|Reported Event|DTG + TDF/FTC|Participants received a three-drug regimen of dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) fixed dose combination (FDC) once daily for 48 weeks.
10777032|NCT02805257|BG000|Baseline|Mitomycin-C|"0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.~Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol"
10777033|NCT02805257|BG001|Baseline|Balanced Salt Solution (BSS)|"0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.~Balanced Salt Solution: Intraoperative and postoperative injections of BSS"
10964294|NCT00876733|BG001|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
10964295|NCT00876733|BG002|Baseline|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
10777034|NCT02805257|BG002|Baseline|Total|Total of all reporting groups
10777035|NCT02805257|FG000|Participant Flow|Mitomycin-C|"0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.~Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol"
10777036|NCT02805257|FG001|Participant Flow|Balanced Salt Solution (BSS)|"0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.~Balanced Salt Solution: Intraoperative and postoperative injections of BSS"
10777037|NCT02805257|OG000|Outcome|Mitomycin-C|"0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.~Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol"
10777038|NCT02805257|OG001|Outcome|Balanced Salt Solution (BSS)|"0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.~Balanced Salt Solution: Intraoperative and postoperative injections of BSS"
10777039|NCT02805257|EG000|Reported Event|Mitomycin-C|"0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.~Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol"
10777040|NCT02805257|EG001|Reported Event|Balanced Salt Solution (BSS)|"0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.~Balanced Salt Solution: Intraoperative and postoperative injections of BSS"
10777041|NCT02780609|BG000|Baseline|Phase 1 Level 1: Selinexor Plus HDM HCT|"40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777042|NCT02780609|BG001|Baseline|Phase 1 Level 2: Selinexor Plus HDM HCT|"60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777043|NCT02780609|BG002|Baseline|Phase 1 Level 3: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777044|NCT02780609|BG003|Baseline|Phase 2: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777045|NCT02780609|BG004|Baseline|Total|Total of all reporting groups
10777046|NCT02780609|FG000|Participant Flow|Phase 1 Level 1: Selinexor Plus HDM HCT|"40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777047|NCT02780609|FG001|Participant Flow|Phase 1 Level 2: Selinexor Plus HDM HCT|"60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777048|NCT02780609|FG002|Participant Flow|Phase 1 Level 3: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777049|NCT02780609|FG003|Participant Flow|Phase 2: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777050|NCT02780609|OG000|Outcome|Selinexor Plus HDM HCT|"The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.~Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10964296|NCT00876733|BG003|Baseline|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
10777051|NCT02780609|OG000|Outcome|Phase 1 Level 1: Selinexor Plus HDM HCT|"40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777052|NCT02780609|OG001|Outcome|Phase 1 Level 2: Selinexor Plus HDM HCT|"60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1)."
10777053|NCT02780609|OG002|Outcome|Phase 1 Level 3: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1)."
10964297|NCT00876733|BG004|Baseline|Total|Total of all reporting groups
10777054|NCT02780609|OG003|Outcome|Phase 2: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777055|NCT02780609|OG000|Outcome|Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777056|NCT02780609|EG000|Reported Event|Phase 1 Level 1: Selinexor Plus HDM HCT|"40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777057|NCT02780609|EG001|Reported Event|Phase 1 Level 2: Selinexor Plus HDM HCT|"60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777058|NCT02780609|EG002|Reported Event|Phase 1 Level 3: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
11193110|NCT02142387|EG000|Reported Event|Newer DA-BLS Training Program|A 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly.
11193111|NCT02142387|EG001|Reported Event|Current BLS Training Program|A one-hour training program that was developed by the Korea CDC and it was based on the AHA BLS provider course (http://www.cdc.go.kr/board.es?mid=a20503050000&bid=0021&tag=&act=view&list_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
11193112|NCT02142504|BG000|Baseline|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
11193113|NCT02142504|BG001|Baseline|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
11193114|NCT02142504|BG002|Baseline|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
11193115|NCT02142504|BG003|Baseline|Total|Total of all reporting groups
11193116|NCT02142504|FG000|Participant Flow|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
10777059|NCT02780609|EG003|Reported Event|Phase 2: Selinexor Plus HDM HCT|"80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion~Melphalan: Melphalan 100 mg/m^2 IV over 30-45 minutes.~Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).~Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.~Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2."
10777060|NCT02747433|BG000|Baseline|ALPS + Robot-Assisted Therapy (RT)|"Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot-assisted Therapy (RT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (1 hr sessions, 3x week for 3 weeks)."
10777061|NCT02747433|BG001|Baseline|ALPS + Robot + Task-Oriented Training (RT-TOT)|"Robot and task-oriented training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot & Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session."
10777062|NCT02747433|BG002|Baseline|Total|Total of all reporting groups
10777063|NCT02747433|FG000|Participant Flow|ALPS + Robot-Assisted Therapy (RT)|"Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot-assisted Therapy (RT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (1 hr sessions, 3x week for 3 weeks)."
10777064|NCT02747433|FG001|Participant Flow|ALPS + Robot + Task-Oriented Training (RT-TOT)|"Robot and task-oriented training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot & Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session."
10777065|NCT02747433|OG000|Outcome|ALPS + Robot-Assisted Therapy (RT)|"Robot training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot-assisted Therapy (RT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (1 hr sessions, 3x week for 3 weeks)."
10777066|NCT02747433|OG001|Outcome|ALPS + Robot + Task-Oriented Training (RT-TOT)|"Robot and task-oriented training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot & Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session."
10777067|NCT02747433|OG002|Outcome|ALPS + RT + RT-TOT|"Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home & community.~The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks."
10777068|NCT02747433|OG001|Outcome|ALPS + Robot & Task-Oriented Training (RT-TOT)|"Robot and task-oriented training was combined with the Active Learning Program for Stroke (ALPS) motor learning program directed toward UE self-management and transfer of training to daily activities in home & community.~Robot & Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session."
10777069|NCT02747433|OG000|Outcome|ALPS + RT + RT-TOT|"Participants in both groups received the Active Learning Program for Stroke (ALPS) motor learning program directed toward upper extremity (UE) self-management and transfer of robot-trained UE skills to daily activities in the home & community.~The ALPS protocol was administered to individuals in the RT group who received intensive upper extremity robot-assisted therapy with the Armeo and Amadeo robots, 1 hr sessions 3x week over 6 weeks (ALPS + RT) and to individuals who received robot-assisted therapy and task- oriented training during each session (ALPS + RT-TOT). Individuals in the RT-TOT group received robot-assisted therapy with the Armeo and Amadeo robots for 30 mins plus task-oriented training for the remaining 30 min of each treatment session, 3x week for 6 weeks."
11193117|NCT02142504|FG001|Participant Flow|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
11193118|NCT02142504|FG002|Participant Flow|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
10777070|NCT02747433|EG000|Reported Event|Robot-Assisted Therapy (RT)|"Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training~Robot-Assisted Therapy (RT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training was accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community."
10777071|NCT02747433|EG001|Reported Event|Robot & Task-Oriented Training (RT-TOT)|"Armeo and Amadeo robot-assisted intensive upper extremity therapy 30 mins, 3x week for 6 weeks plus ALPS training. Task oriented training was provided for remaining 30 min of each treatment session~Robot & Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session. Robot and task oriented training was accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community."
10777072|NCT02696564|BG000|Baseline|Losartan|"At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.~Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated"
10964298|NCT00876733|FG000|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
10777073|NCT02696564|BG001|Baseline|Placebo|"At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.~Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks"
10777074|NCT02696564|BG002|Baseline|Total|Total of all reporting groups
10777075|NCT02696564|FG000|Participant Flow|Losartan|"At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.~Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated"
10777076|NCT02696564|FG001|Participant Flow|Placebo|"At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.~Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks"
10777077|NCT02696564|OG000|Outcome|Losartan|"At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.~Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated"
10777078|NCT02696564|OG001|Outcome|Placebo|"At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.~Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks"
10777079|NCT02696564|EG000|Reported Event|Losartan|"At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.~Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated"
10777080|NCT02696564|EG001|Reported Event|Placebo|"At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.~Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks"
10777093|NCT02685826|BG000|Baseline|Cohort A: High Risk, TNE|High risk, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
10777094|NCT02685826|BG001|Baseline|Cohort B: >=65 Years Old, TNE|>= 65 years old, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
10777095|NCT02685826|BG002|Baseline|Cohort C: High Risk, Post-transplant|High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
10777096|NCT02685826|BG003|Baseline|Total|Total of all reporting groups
10777097|NCT02685826|FG000|Participant Flow|Cohort A: High Risk, TNE|High risk, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
10777098|NCT02685826|FG001|Participant Flow|Cohort B: >=65 Years Old, TNE|>= 65 years old, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
10777099|NCT02685826|FG002|Participant Flow|Cohort C: High Risk, Post-transplant|High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
10777100|NCT02685826|OG000|Outcome|Cohort A: High Risk, TNE|High risk, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
10777101|NCT02685826|OG001|Outcome|Cohort B: >=65 Years Old, TNE|>= 65 years old, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
10777102|NCT02685826|OG002|Outcome|Cohort C: High Risk, Post-transplant|High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
10777103|NCT02685826|EG000|Reported Event|Cohort A: High Risk, TNE|"High risk, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were administered~Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle~Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle~Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle."
11193119|NCT02142504|OG000|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
10777104|NCT02685826|EG001|Reported Event|Cohort B: >=65 Years Old, TNE|">= 65 years old, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered~Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle~Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl] value) on Days 1 to 21 of each 28-day treatment cycle~Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles."
10777105|NCT02685826|EG002|Reported Event|Cohort C: High Risk, Post-transplant|"High risk, post-transplant NDMM participants were administered the following as maintenance therapy:~Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle."
11193120|NCT02142504|OG001|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
11193121|NCT02142504|OG002|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
10964299|NCT00876733|FG001|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
10964300|NCT00876733|FG002|Participant Flow|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
10964301|NCT00876733|FG003|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
10964302|NCT00876733|OG000|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
10964303|NCT00876733|OG001|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
10964304|NCT00876733|OG002|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
10964305|NCT00876733|OG003|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
10964306|NCT00876733|EG000|Reported Event|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
10964307|NCT00876733|EG001|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
10964308|NCT00876733|EG002|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
10964309|NCT00876733|EG003|Reported Event|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
10964310|NCT00876915|BG000|Baseline|High Risk Randomized to Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
10964311|NCT00876915|BG001|Baseline|High Risk Randomized to No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
10964312|NCT00876915|BG002|Baseline|Low Risk|Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
10964313|NCT00876915|BG003|Baseline|Total|Total of all reporting groups
10964314|NCT00876915|FG000|Participant Flow|High Risk Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
10777116|NCT02663622|BG000|Baseline|Placebo|Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10964315|NCT00876915|FG001|Participant Flow|High Risk No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
10964316|NCT00876915|FG002|Participant Flow|Low or Medium Risk Group|Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
10964317|NCT00876915|OG000|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
11193122|NCT02142504|EG000|Reported Event|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
11193123|NCT02142504|EG001|Reported Event|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
10964318|NCT00876915|OG001|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
10964319|NCT00876915|OG000|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
10964320|NCT00876915|OG001|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
10964321|NCT00876915|EG000|Reported Event|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
10964322|NCT00876915|EG001|Reported Event|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
10964323|NCT00876928|BG000|Baseline|Placebo|Subjects with low vitamin D levels and pre-diabetes
10964324|NCT00876928|BG001|Baseline|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
11193124|NCT02142504|EG002|Reported Event|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
11193125|NCT02142608|BG000|Baseline|BR55|All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
11193126|NCT02142608|FG000|Participant Flow|BR55|All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
11193127|NCT02142608|OG000|Outcome|BR55|Ultrasound Image Assessment
10964325|NCT00876928|BG002|Baseline|Total|Total of all reporting groups
10964326|NCT00876928|FG000|Participant Flow|Placebo|"Subjects with low vitamin D levels and pre-diabetes~Medium chain triglyceride given once per week"
10964327|NCT00876928|FG001|Participant Flow|Vitamin D|"Subjects with low vitamin D levels and pre-diabetes~Liquid vitamin D3 dissolved in medium chain triglyceride once per week"
10964328|NCT00876928|OG000|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
10964329|NCT00876928|OG001|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
10964330|NCT00876928|EG000|Reported Event|Placebo|Subjects with low vitamin D levels and pre-diabetes
10964331|NCT00876928|EG001|Reported Event|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
10777117|NCT02663622|BG001|Baseline|CD24Fc 240 mg|CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777118|NCT02663622|BG002|Baseline|CD24Fc 480 mg|CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777119|NCT02663622|BG003|Baseline|CD24Fc 960 mg|CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777120|NCT02663622|BG004|Baseline|Total|Total of all reporting groups
10777121|NCT02663622|FG000|Participant Flow|Placebo|Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777122|NCT02663622|FG001|Participant Flow|CD24Fc 240 mg|CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777123|NCT02663622|FG002|Participant Flow|CD24Fc 480 mg|CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777124|NCT02663622|FG003|Participant Flow|CD24Fc 960 mg|CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777125|NCT02663622|OG000|Outcome|Placebo|Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777126|NCT02663622|OG001|Outcome|CD24Fc 240 mg|CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777127|NCT02663622|OG002|Outcome|CD24Fc 480 mg|CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777128|NCT02663622|OG003|Outcome|CD24Fc 960 mg|CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777129|NCT02663622|OG000|Outcome|CD24Fc 960 mg|CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777130|NCT02663622|EG000|Reported Event|Placebo|Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777131|NCT02663622|EG001|Reported Event|CD24Fc 240 mg|CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777132|NCT02663622|EG002|Reported Event|CD24Fc 480 mg|CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10777133|NCT02663622|EG003|Reported Event|CD24Fc 960 mg (Multi-dose)|CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
10964332|NCT00876993|BG000|Baseline|Cohort 1 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964333|NCT00876993|BG001|Baseline|Cohort 2 - Dose Level 0|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 75 mg/m^2 PO days 1-5 28 day cycle
10964334|NCT00876993|BG002|Baseline|Cohort 3 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
11193128|NCT02142608|OG000|Outcome|BR55|All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
11193129|NCT02142608|EG000|Reported Event|BR55|All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
11193130|NCT02142712|BG000|Baseline|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
10964335|NCT00876993|BG003|Baseline|Cohort 4 - Dose Level 2|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 175 mg/m^2 PO days 1-5 28 day cycle
10964336|NCT00876993|BG004|Baseline|Cohort 5 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964337|NCT00876993|BG005|Baseline|Total|Total of all reporting groups
10964338|NCT00876993|FG000|Participant Flow|Cohort 1 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964339|NCT00876993|FG001|Participant Flow|Cohort 2 - Dose Level 0|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 75 mg/m^2 PO days 1-5 28 day cycle
10964340|NCT00876993|FG002|Participant Flow|Cohort 3 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964341|NCT00876993|FG003|Participant Flow|Cohort 4 - Dose Level 2|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 175 mg/m^2 PO days 1-5 28 day cycle
10964342|NCT00876993|FG004|Participant Flow|Cohort 5 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964343|NCT00876993|OG000|Outcome|Cohort 1 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964344|NCT00876993|OG001|Outcome|Cohort 2 - Dose Level 0|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 75 mg/m^2 PO days 1-5 28 day cycle
10964345|NCT00876993|OG002|Outcome|Cohort 3 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964346|NCT00876993|OG003|Outcome|Cohort 4 - Dose Level 2|BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 175 mg/m^2 PO days 1-5 28 day cycle
10964347|NCT00876993|OG004|Outcome|Cohort 5 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964348|NCT00876993|OG003|Outcome|Cohort 4 - Dose Level 2|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 175 mg/m^2 PO days 1-5 28 day cycle
10964349|NCT00876993|OG004|Outcome|Cohort 5 - Dose Level 1|BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964350|NCT00876993|EG000|Reported Event|Cohort 1 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964351|NCT00876993|EG001|Reported Event|Cohort 2 - Dose Level 0|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 75 mg/m^2 PO days 1-5 28 day cycle
10964352|NCT00876993|EG002|Reported Event|Cohort 3 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964353|NCT00876993|EG003|Reported Event|Cohort 4 - Dose Level 2|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 175 mg/m^2 PO days 1-5 28 day cycle
10964354|NCT00876993|EG004|Reported Event|Cohort 5 - Dose Level 1|Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m^2 IV days 1 and 15 Temozolomide 125 mg/m^2 PO days 1-5 28 day cycle
10964355|NCT00877006|BG000|Baseline|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
10964356|NCT00877006|BG001|Baseline|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
10964357|NCT00877006|BG002|Baseline|Total|Total of all reporting groups
10964358|NCT00877006|FG000|Participant Flow|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
10964359|NCT00877006|FG001|Participant Flow|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
10964360|NCT00877006|OG000|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
10964361|NCT00877006|OG001|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
10964362|NCT00877006|OG000|Outcome|Bendamustine/Rituximab|bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1
11193131|NCT02142712|BG001|Baseline|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
11193132|NCT02142712|BG002|Baseline|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
11193133|NCT02142712|BG003|Baseline|Total|Total of all reporting groups
11193134|NCT02142712|FG000|Participant Flow|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
10964363|NCT00877006|OG001|Outcome|R-CHOP/R-CVP|"R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.~R-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1."
10964364|NCT00877006|EG000|Reported Event|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
10964365|NCT00877006|EG001|Reported Event|R-CHOP/CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
10964366|NCT00877032|BG000|Baseline|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
10964367|NCT00877032|BG001|Baseline|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964368|NCT00877032|BG002|Baseline|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
10777151|NCT02640950|BG000|Baseline|Patients With Bipolar (I or II) Depression|Adults with bipolar (I or II) depression, per DSM-5 criteria, were recruited at Sheppard Pratt and Mayo Clinic between December 2015-February 2020 for TMS. Standardized treatment protocols employed 6 weeks of 10 Hz TMS to the left dorsolateral prefrontal cortex at 120% of motor threshold with 3,000 pulses per session in 4 second trains with intertrain intervals of 26 seconds. All patients were treated concurrently with a mood stabilizer. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Response and remission were defined as MADRS score reductions of ≥ 50% or score ≤10, respectively. We examined response, remission, and potential contributing factors with multivariate and logistic regression models.
10777152|NCT02640950|FG000|Participant Flow|Patients With Bipolar (I or II) Depression|Adults with bipolar (I or II) depression, per DSM-5 criteria, were recruited at Sheppard Pratt and Mayo Clinic between December 2015-February 2020 for TMS. Standardized treatment protocols employed 6 weeks of 10 Hz TMS to the left dorsolateral prefrontal cortex at 120% of motor threshold with 3,000 pulses per session in 4 second trains with intertrain intervals of 26 seconds. All patients were treated concurrently with a mood stabilizer. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Response and remission were defined as MADRS score reductions of ≥ 50% or score ≤10, respectively. We examined response, remission, and potential contributing factors with multivariate and logistic regression models.
10777153|NCT02640950|OG000|Outcome|Patients With Bipolar (I or II) Depression|Adults with bipolar (I or II) depression, per DSM-5 criteria, were recruited at Sheppard Pratt and Mayo Clinic between December 2015 -February 2020 for TMS. Standardized treatment protocols employed 6 weeks of 10 Hz TMS to the left dorsolateral prefrontal cortex at 120% of motor threshold with 3,000 pulses per session in 4 second trains with intertrain intervals of 26 seconds. All patients were treated concurrently with a mood stabilizer. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Response and remission were defined as MADRS score reductions of ≥ 50% or score ≤10, respectively. We examined response, remission, and potential contributing factors with multivariate and logistic regression models.
10964369|NCT00877032|BG003|Baseline|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964370|NCT00877032|BG004|Baseline|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964371|NCT00877032|BG005|Baseline|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964372|NCT00877032|BG006|Baseline|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
10964373|NCT00877032|BG007|Baseline|Total|Total of all reporting groups
10964374|NCT00877032|FG000|Participant Flow|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
10964375|NCT00877032|FG001|Participant Flow|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964376|NCT00877032|FG002|Participant Flow|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964377|NCT00877032|FG003|Participant Flow|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
11193135|NCT02142712|FG001|Participant Flow|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
10964378|NCT00877032|FG004|Participant Flow|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964379|NCT00877032|FG005|Participant Flow|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964380|NCT00877032|FG006|Participant Flow|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
10964381|NCT00877032|OG000|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
10964382|NCT00877032|OG001|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964383|NCT00877032|OG002|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964384|NCT00877032|OG003|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964385|NCT00877032|OG004|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
10777154|NCT02640950|EG000|Reported Event|Patients With Bipolar (I or II) Depression|Thirty-one adults (13M/18F; age: 42.2[14.3]) with bipolar (I or II) depression, per DSM-5 criteria, were recruited at Sheppard Pratt and Mayo Clinic between December 2015-February 2020 for TMS. Standardized treatment protocols employed 6 weeks of 10 Hz TMS to the left dorsolateral prefrontal cortex at 120% of motor threshold with 3,000 pulses per session in 4 second trains with intertrain intervals of 26 seconds. All patients were treated concurrently with a mood stabilizer. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Response and remission were defined as MADRS score reductions of ≥ 50% or score ≤10, respectively. We examined response, remission, and potential contributing factors with multivariate and logistic regression models.
10777155|NCT02639065|BG000|Baseline|Investigational Treatment|Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
10777156|NCT02639065|FG000|Participant Flow|Investigational Treatment|Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
10777157|NCT02639065|OG000|Outcome|Investigational Treatment|Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
10777158|NCT02639065|EG000|Reported Event|Investigational Treatment|Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
10800923|NCT03338816|EG002|Reported Event|Placebo/Givosiran|Patients who received placebo during the 6-Month DB Period then entered the Open-Label Extension (OLE) Period and were administered givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months. Upon implementation of protocol Amendment 5, active patients receiving 1.25 mg/kg givosiran once monthly in the OLE had their dose increased to 2.5 mg/kg givosiran once monthly.
10800924|NCT03338816|EG003|Reported Event|Givosiran/Givosiran|Patients who received givosiran during the 6-Month DB Period then entered the OLE Period and were administered givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM mg/kg for 29 months. Upon implementation of protocol Amendment 5, active patients receiving 1.25 mg/kg givosiran once monthly in the OLE had their dose increased to 2.5 mg/kg givosiran once monthly.
10800925|NCT03338816|EG004|Reported Event|All Givosiran|All participants treated with any amount of givosiran.
10800926|NCT03318809|BG000|Baseline|Group 1: Severely Renal Impaired Participants|Participants with severely impaired renal function (eGFR 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986.
10800927|NCT03318809|BG001|Baseline|Group 2: Healthy Participants|Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986.
10800928|NCT03318809|BG002|Baseline|Total|Total of all reporting groups
10800929|NCT03318809|FG000|Participant Flow|Group 1: Severely Renal Impaired Participants|Participants with severely impaired renal function (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986.
10800930|NCT03318809|FG001|Participant Flow|Group 2: Healthy Participants|Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986.
10800931|NCT03318809|OG000|Outcome|Group 1: Severely Renal Impaired Participants|Participants with severely impaired renal function (eGFR 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986.
10800932|NCT03318809|OG001|Outcome|Group 2: Healthy Participants|Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986.
10800933|NCT03318809|EG000|Reported Event|Group 1: Severely Renal Impaired Participants|Participants with severely impaired renal function (eGFR 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986.
10800934|NCT03318809|EG001|Reported Event|Group 2: Healthy Participants|Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986.
10800935|NCT03317496|BG000|Baseline|Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11193136|NCT02142712|FG002|Participant Flow|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
10800936|NCT03317496|BG001|Baseline|Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800937|NCT03317496|BG002|Baseline|Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800938|NCT03317496|BG003|Baseline|Phase 1b and 2: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm.
11193137|NCT02142712|FG003|Participant Flow|Dextromethorphan|Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care
10777159|NCT02564263|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
10777160|NCT02564263|BG001|Baseline|Chemotherapy|Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
10777161|NCT02564263|BG002|Baseline|Total|Total of all reporting groups
10777162|NCT02564263|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
10777163|NCT02564263|FG001|Participant Flow|Chemotherapy|Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
10777164|NCT02564263|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
10777165|NCT02564263|OG001|Outcome|Chemotherapy|Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
10777166|NCT02564263|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
10777167|NCT02564263|EG001|Reported Event|Chemotherapy|Participants received Investigator's choice of paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
10777168|NCT02422615|BG000|Baseline|Ribociclib + Fulvestrant|Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777169|NCT02422615|BG001|Baseline|Ribociclib Placebo + Fulvestrant|Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777170|NCT02422615|BG002|Baseline|Total|Total of all reporting groups
10777171|NCT02422615|FG000|Participant Flow|Ribociclib + Fulvestrant|Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777172|NCT02422615|FG001|Participant Flow|Ribociclib Placebo + Fulvestrant|Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
11193138|NCT02142712|OG000|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
10777173|NCT02422615|OG000|Outcome|Ribociclib + Fulvestrant|Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777174|NCT02422615|OG001|Outcome|Ribociclib Placebo + Fulvestrant|Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777175|NCT02422615|EG000|Reported Event|Ribociclib + Fulvestrant|Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777176|NCT02422615|EG001|Reported Event|Ribociclib Placebo + Fulvestrant|Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
10777177|NCT02372136|BG000|Baseline|Individualized and Optimized Nutrition|Both individualized and optimized nutrition
10777178|NCT02372136|BG001|Baseline|Optimized Nutrition|Optimized nutrition only
10777179|NCT02372136|BG002|Baseline|Total|Total of all reporting groups
10777180|NCT02372136|FG000|Participant Flow|Individualized and Optimized Nutrition|"Individualized nutrition Optimized nutrition~Individualized Nutrition: Intake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis.~In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas.~In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91).~Optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length)."
10777181|NCT02372136|FG001|Participant Flow|Optimized Nutrition|"Optimized nutrition~Optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length)."
10800939|NCT03317496|BG004|Baseline|Total|Total of all reporting groups
10964386|NCT00877032|OG005|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964387|NCT00877032|OG006|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
11193139|NCT02142712|OG001|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
10777182|NCT02372136|OG000|Outcome|Individualized and Optimized Nutrition|"Individualized nutrition Optimized nutrition~Individualized Nutrition: Intake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis.~In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas.~In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91).~Optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length)."
10777183|NCT02372136|OG001|Outcome|Optimized Nutrition|"Optimized nutrition~Optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length)."
11193140|NCT02142712|OG002|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
10777184|NCT02372136|OG000|Outcome|Individualized and Optimized Nutrition|Both individualized and optimized nutrition
10777185|NCT02372136|OG001|Outcome|Optimized Nutrition|Optimized nutrition only
10777186|NCT02372136|EG000|Reported Event|Experimental|Optimized and individualized nutrition
10777187|NCT02372136|EG001|Reported Event|Control|Optimized nutrition
10777188|NCT02367456|BG000|Baseline|Lead-in Cohort|Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
10777189|NCT02367456|BG001|Baseline|AML Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777190|NCT02367456|BG002|Baseline|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777191|NCT02367456|BG003|Baseline|Total|Total of all reporting groups
11193141|NCT02142712|OG001|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
11193142|NCT02142712|EG000|Reported Event|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
10777192|NCT02367456|FG000|Participant Flow|Lead-in Cohort|Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit drug-drug interaction (DDI) evaluation.
10777193|NCT02367456|FG001|Participant Flow|AML Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777194|NCT02367456|FG002|Participant Flow|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777195|NCT02367456|OG000|Outcome|Lead-in Cohort|Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
10777196|NCT02367456|OG000|Outcome|AML Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777197|NCT02367456|OG001|Outcome|MDS Cohort|Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
11193143|NCT02142712|EG001|Reported Event|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
11193144|NCT02142712|EG002|Reported Event|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
11193145|NCT02142894|BG000|Baseline|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
11193146|NCT02142894|FG000|Participant Flow|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
10777198|NCT02367456|OG001|Outcome|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777199|NCT02367456|OG000|Outcome|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777200|NCT02367456|OG000|Outcome|AML Cohort|Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
10777201|NCT02367456|OG001|Outcome|AML Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777202|NCT02367456|OG002|Outcome|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777203|NCT02367456|EG000|Reported Event|Lead-in Cohort|Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
10777204|NCT02367456|EG001|Reported Event|AML Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777205|NCT02367456|EG002|Reported Event|MDS Cohort|Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
10777206|NCT02091960|BG000|Baseline|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
10777207|NCT02091960|FG000|Participant Flow|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
10777208|NCT02091960|OG000|Outcome|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
11193147|NCT02142894|OG000|Outcome|Symptomatic|Evaluation of clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms indicating TB disease.
11193148|NCT02142894|EG000|Reported Event|Symptomatic|Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.
11193149|NCT02143024|BG000|Baseline|Family-based Depression Intervention|"The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker~Family-based depression intervention: The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members."
11193150|NCT02143024|BG001|Baseline|Usual Care Plus Educational Materials|"Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.~Usual care plus educational materials: Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression."
11193151|NCT02143024|BG002|Baseline|Total|Total of all reporting groups
10777209|NCT02091960|EG000|Reported Event|Enzalutamide + Trastuzumab|Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
10777210|NCT02022033|BG000|Baseline|FOLFOXA|"Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)"
10777211|NCT02022033|FG000|Participant Flow|FOLFOXA|"Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)"
10777212|NCT02022033|OG000|Outcome|FOLFOXA|"Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)"
11193152|NCT02143024|FG000|Participant Flow|Family-based Depression Intervention|"The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker~Family-based depression intervention: The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members."
11193153|NCT02143024|FG001|Participant Flow|Usual Care Plus Educational Materials|"Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.~Usual care plus educational materials: Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression."
10777213|NCT02022033|EG000|Reported Event|FOLFOXA|"Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)"
10964388|NCT00877032|EG000|Reported Event|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
10964389|NCT00877032|EG001|Reported Event|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
10777214|NCT01942135|BG000|Baseline|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777215|NCT01942135|BG001|Baseline|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777216|NCT01942135|BG002|Baseline|Total|Total of all reporting groups
10777217|NCT01942135|FG000|Participant Flow|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777218|NCT01942135|FG001|Participant Flow|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777219|NCT01942135|OG000|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777220|NCT01942135|OG001|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777221|NCT01942135|EG000|Reported Event|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777222|NCT01942135|EG001|Reported Event|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
10777223|NCT01434602|BG000|Baseline|Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily|Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.
10777224|NCT01434602|BG001|Baseline|Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily|Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777225|NCT01434602|BG002|Baseline|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777226|NCT01434602|BG003|Baseline|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777227|NCT01434602|BG004|Baseline|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
11339686|NCT03635086|EG001|Reported Event|Group B: Two MV-CHIK Liquid Frozen Low Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
10777228|NCT01434602|BG005|Baseline|Total|Total of all reporting groups
10777229|NCT01434602|FG000|Participant Flow|Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily|Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.
10777230|NCT01434602|FG001|Participant Flow|Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily|Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777231|NCT01434602|FG002|Participant Flow|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777232|NCT01434602|FG003|Participant Flow|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777233|NCT01434602|FG004|Participant Flow|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777234|NCT01434602|OG000|Outcome|All Participants|"All participants with recurrent malignant glioma, with or without prior exposure to bevacizumab on phase I dose level 1 and phase I dose level-1.~Phase I Dose Level 1: Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28).~Phase I Dose Level -1:~Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). Sorafenib will be given on days 1-7 and days 15-21.~There is not a defined set maximum number of cycles that a participant may have."
10777235|NCT01434602|OG000|Outcome|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777236|NCT01434602|OG000|Outcome|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777237|NCT01434602|OG000|Outcome|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777238|NCT01434602|OG001|Outcome|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777239|NCT01434602|OG002|Outcome|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777240|NCT01434602|OG000|Outcome|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777241|NCT01434602|OG000|Outcome|Phase 1 Dose LEvel 1 Sorafenib 400mg Twice Daily + Everolimus 5mg Daily|Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.
10777242|NCT01434602|OG001|Outcome|Phase 1 Dose Level -1 Sorafenib 400mg Twice Daily 7 Days On, & Days Off + Everolimus Daily|Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777243|NCT01434602|OG002|Outcome|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777244|NCT01434602|OG003|Outcome|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777245|NCT01434602|OG004|Outcome|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777246|NCT01434602|OG000|Outcome|Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily|Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.
10777247|NCT01434602|OG001|Outcome|Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily|Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777248|NCT01434602|OG002|Outcome|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777249|NCT01434602|EG000|Reported Event|Phase I Dose Level I Sorafenib 400mg Twice Daily + Everolimus 5mg Daily|Phase I Dose Level 1 Dose Escalation Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.
10777250|NCT01434602|EG001|Reported Event|Phase I Dose Level -1 Sorafenib 400mg Twice Daily, 7 Days on, 7 Off + Everolimus 5mg Daily|Phase I Dose Level -1 Dose Escalation Phase Participants with recurrent malignant glioma, with or without prior exposure to bevacizumab will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777251|NCT01434602|EG002|Reported Event|Phase 2 Group A Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with no prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777252|NCT01434602|EG003|Reported Event|Phase 2 Group B Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|"Phase 2 Recommended Phase 2 Dose Recurrent glioblastoma with prior exposure to bevacizumab Participants will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have.~Sorafenib will be given on days 1-7 and days 15-21."
10777253|NCT01434602|EG004|Reported Event|Phase 2 Group C Dose Level -1 Sorafenib 400mg Twice Daily 7 Days on, 7 Off + Everolimus 5mg Daily|Phase 2 recommended phase 2 dose Participants with Anaplastic Glioma with no prior exposure to bevacizumab (Grade III Glioma Group) will be treated with Sorafenib 400mg twice daily 7 days on, 7 days off + Everolimus 5 mg daily by mouth (days 1-28). There is not a defined set maximum number of cycles that a patient may have. Sorafenib will be given on days 1-7 and days 15-21.
10777254|NCT01358877|BG000|Baseline|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
10777255|NCT01358877|BG001|Baseline|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
10777256|NCT01358877|BG002|Baseline|Total|Total of all reporting groups
10964390|NCT00877032|EG002|Reported Event|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
10964391|NCT00877032|EG003|Reported Event|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
10777257|NCT01358877|FG000|Participant Flow|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
10777258|NCT01358877|FG001|Participant Flow|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).
10777259|NCT01358877|OG000|Outcome|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
10777260|NCT01358877|OG001|Outcome|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
10777261|NCT01358877|EG000|Reported Event|Pertuzumab + Trastuzumab + Chemotherapy|Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
10777262|NCT01358877|EG001|Reported Event|Placebo + Trastuzumab + Chemotherapy|Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 mg).
10800940|NCT03317496|FG000|Participant Flow|Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin|Participants with advanced non-squamous non-small cell lung cancer (NSCLC) received avelumab 800 milligrams (mg) as an intravenous (IV) infusion over 1 hour every 3 weeks (Q3W) in combination with IV infusion of pemetrexed 500 milligram per square meter (mg/m^2) and carboplatin dose at area under curve (AUC) 5 (carboplatin dose [mg] = target AUC * glomerular filtration rate[GFR] milliliter per minute [mL/min] + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11339687|NCT03635086|EG002|Reported Event|Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
10777272|NCT01239797|BG000|Baseline|Lenalidomide + Dexamethasone + Elotuzumab|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
10777273|NCT01239797|BG001|Baseline|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
10777274|NCT01239797|BG002|Baseline|Total|Total of all reporting groups
10777275|NCT01239797|FG000|Participant Flow|Lenalidomide + Dexamethasone + Elotuzumab|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
10777276|NCT01239797|FG001|Participant Flow|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
10850888|NCT04262947|EG001|Reported Event|VeinViewer Visualization Only|"Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement~Conventional IV placement: IV placement utilizing conventional methods"
10777277|NCT01239797|OG000|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
10777278|NCT01239797|OG001|Outcome|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
10777279|NCT01239797|EG000|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
10777280|NCT01239797|EG001|Reported Event|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
10777281|NCT01236521|BG000|Baseline|Arm 1: Pharmacological (PHARM)|Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling.
10777282|NCT01236521|BG001|Baseline|Arm 2: Behavioral Treatment (BEH)|Veterans randomized to behavioral treatment arm (BEH) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
10777283|NCT01236521|BG002|Baseline|Total|Total of all reporting groups
10777284|NCT01236521|FG000|Participant Flow|Arm 1: Pharmacological (PHARM)|"Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants had an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment was assessed.~Analgesic and co-analgesic therapy: During the baseline assessment, the nurse care managers determined current and past treatments for chronic lower back pain."
10777285|NCT01236521|FG001|Participant Flow|Arm 2: Behavioral Treatment (BEH)|Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
10777286|NCT01236521|OG000|Outcome|Arm 1: Pharmacological (PHARM)|Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.
10777287|NCT01236521|OG001|Outcome|Arm 2: Behavioral Treatment (BEH)|Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
10777288|NCT01236521|EG000|Reported Event|Arm 1: Pharmacological (PHARM)|Nurse care managers followed an analgesic algorithm; supervised by study physicians
10777289|NCT01236521|EG001|Reported Event|Arm 2: Behavioral Treatment (BEH)|Clinical psychologist delivered pain self-management/pain coping skills to Veterans
10777290|NCT01103349|BG000|Baseline|Placebo|Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777291|NCT01103349|BG001|Baseline|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777292|NCT01103349|BG002|Baseline|Montelukast 10 mg qd|Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
10777293|NCT01103349|BG003|Baseline|Total|Total of all reporting groups
10964392|NCT00877032|EG004|Reported Event|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
11339688|NCT03635086|EG003|Reported Event|Group D: Two MV-CHIK Liquid Frozen High Dose|Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
10777294|NCT01103349|FG000|Participant Flow|Placebo|Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777295|NCT01103349|FG001|Participant Flow|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777296|NCT01103349|FG002|Participant Flow|Montelukast 10 mg qd|Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
10777297|NCT01103349|OG000|Outcome|Placebo|Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777298|NCT01103349|OG001|Outcome|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777299|NCT01103349|OG002|Outcome|Montelukast 10 mg qd|Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
10777300|NCT01103349|EG000|Reported Event|Placebo|Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777301|NCT01103349|EG001|Reported Event|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks.
10777302|NCT01103349|EG002|Reported Event|Montelukast 10 mg qd|Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks.
10777303|NCT01092143|BG000|Baseline|Placebo|Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777304|NCT01092143|BG001|Baseline|BI 671800 50 mg Bid|Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777305|NCT01092143|BG002|Baseline|BI 671800 200 mg Bid|Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777306|NCT01092143|BG003|Baseline|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777307|NCT01092143|BG004|Baseline|Fluticasone 220 mcg Bid|Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777308|NCT01092143|BG005|Baseline|Total|Total of all reporting groups
10777309|NCT01092143|FG000|Participant Flow|Placebo|Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777310|NCT01092143|FG001|Participant Flow|BI 671800 50 mg Bid|Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777311|NCT01092143|FG002|Participant Flow|BI 671800 200 mg Bid|Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777312|NCT01092143|FG003|Participant Flow|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777313|NCT01092143|FG004|Participant Flow|Fluticasone 220 mcg Bid|Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777314|NCT01092143|OG000|Outcome|Placebo|Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777315|NCT01092143|OG001|Outcome|BI 671800 50 mg Bid|Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10964393|NCT00877032|EG005|Reported Event|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
10777316|NCT01092143|OG002|Outcome|BI 671800 200 mg Bid|Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777317|NCT01092143|OG003|Outcome|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777318|NCT01092143|OG004|Outcome|Fluticasone 220 mcg Bid|Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777319|NCT01092143|EG000|Reported Event|Placebo|Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777320|NCT01092143|EG001|Reported Event|BI 671800 50 mg Bid|Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777321|NCT01092143|EG002|Reported Event|BI 671800 200 mg Bid|Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777322|NCT01092143|EG003|Reported Event|BI 671800 400 mg Bid|Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
10777323|NCT01092143|EG004|Reported Event|Fluticasone 220 mcg Bid|Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks.
11193154|NCT02143024|OG000|Outcome|Family-based Depression Intervention|"The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker~Family-based depression intervention: The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members."
10800941|NCT03317496|FG001|Participant Flow|Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with urothelial cancer (UC) received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800942|NCT03317496|FG002|Participant Flow|Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800943|NCT03317496|FG003|Participant Flow|Phase 1b Lead-in: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800944|NCT03317496|FG004|Participant Flow|Phase 2: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800945|NCT03317496|OG000|Outcome|Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11193155|NCT02143024|OG001|Outcome|Usual Care Plus Educational Materials|"Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.~Usual care plus educational materials: Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression."
10800946|NCT03317496|OG001|Outcome|Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800947|NCT03317496|OG002|Outcome|Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10964394|NCT00877032|EG006|Reported Event|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
10777343|NCT01004029|BG000|Baseline|Vehicle|"Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777344|NCT01004029|BG001|Baseline|17P (Hydroxyprogesterone Caproate Injection)|"HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777345|NCT01004029|BG002|Baseline|Total|Total of all reporting groups
10777346|NCT01004029|FG000|Participant Flow|Vehicle|"Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777347|NCT01004029|FG001|Participant Flow|17P (Hydroxyprogesterone Caproate Injection)|"HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777348|NCT01004029|OG000|Outcome|Vehicle|"Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777349|NCT01004029|OG001|Outcome|17P (Hydroxyprogesterone Caproate Injection)|"HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777350|NCT01004029|OG001|Outcome|Hydroxyprogesterone Caproate Injection, 250 mg/mL|"HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
11193156|NCT02143024|EG000|Reported Event|Family-based Depression Intervention|"The family-focused component will consist of up to up to 10 joint (i.e. older man alone and/or with family members) sessions that will cover specific topics related to family support of men's depression care provided by a clinic-based social worker~Family-based depression intervention: The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members."
11193157|NCT02143024|EG001|Reported Event|Usual Care Plus Educational Materials|"Control subjects will receive usual care in the clinic enhanced by a single depression psychoeducation session.~Usual care plus educational materials: Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression."
11193158|NCT02143102|BG000|Baseline|Development Set|Data from subjects in the training set will be utilized to further develop the vascuCAP measurements.
10777351|NCT01004029|EG000|Reported Event|Vehicle|"Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777352|NCT01004029|EG001|Reported Event|17P (Hydroxyprogesterone Caproate Injection)|"HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first."
10777353|NCT00640133|BG000|Baseline|Active DBS|"Participants will receive deep brain stimulation.~Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout."
10777354|NCT00640133|BG001|Baseline|Sham DBS|"Participants will receive sham deep brain stimulation for 3 months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS."
10777355|NCT00640133|BG002|Baseline|Total|Total of all reporting groups
10777356|NCT00640133|FG000|Participant Flow|Active DBS|"Participants will receive deep brain stimulation.~Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout."
10777357|NCT00640133|FG001|Participant Flow|Sham DBS|"Participants will receive sham deep brain stimulation for three months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.~Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout."
10777358|NCT00640133|OG000|Outcome|Active DBS|"Participants will receive deep brain stimulation.~Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout."
11193159|NCT02143102|BG001|Baseline|Testing Set|Data from subjects in the testing set will be used to assess the study endpoints.
11193160|NCT02143102|BG002|Baseline|Total|Total of all reporting groups
11193161|NCT02143102|FG000|Participant Flow|Development Set|Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.
10777359|NCT00640133|OG001|Outcome|Sham DBS|"Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.~Afterwards, all participants will receive open-label long-term DBS."
10777360|NCT00640133|OG001|Outcome|Sham DBS|"Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months."
10777361|NCT00640133|OG001|Outcome|Sham DBS|"Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterward"
10777362|NCT00640133|EG000|Reported Event|Active DBS|"Participants will receive deep brain stimulation.~Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout."
10777363|NCT00640133|EG001|Reported Event|Sham DBS|"Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.~Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months.~Afterwards, all participants will receive open-label long-term DBS."
10777364|NCT00593567|BG000|Baseline|Gentamicin Sponge|"Daily topical gentamicin sponge and standard daily wound care~gentamicin-collagen sponge: Inserted daily into open ulcer"
10777365|NCT00593567|BG001|Baseline|Levofloxacin|"Daily oral levofloxacin 750 mg and standard daily wound care~Levofloxacin: 750mg oral levofloxacin daily"
10777366|NCT00593567|BG002|Baseline|Total|Total of all reporting groups
10777367|NCT00593567|FG000|Participant Flow|Gentamicin Sponge|"Daily topical gentamicin sponge and standard daily wound care~gentamicin-collagen sponge: Inserted daily into open ulcer"
10777368|NCT00593567|FG001|Participant Flow|Levofloxacin|"Daily oral levofloxacin 750 mg and standard daily wound care~Levofloxacin: 750mg oral levofloxacin daily"
10777369|NCT00593567|OG000|Outcome|Gentamicin Sponge|"Daily topical gentamicin sponge and standard daily wound care~gentamicin-collagen sponge: Inserted daily into open ulcer"
10777370|NCT00593567|OG001|Outcome|Levofloxacin|"Daily oral levofloxacin 750 mg and standard daily wound care~Levofloxacin: 750mg oral levofloxacin daily"
10777371|NCT00593567|EG000|Reported Event|Gentamicin Sponge|"Daily topical gentamicin sponge and standard daily wound care~gentamicin-collagen sponge: Inserted daily into open ulcer"
11193162|NCT02143102|FG001|Participant Flow|Testing Set|Data from subjects in the testing set will be used to assess the study endpoints.
10777372|NCT00593567|EG001|Reported Event|Levofloxacin|"Daily oral levofloxacin 750 mg and standard daily wound care~Levofloxacin: 750mg oral levofloxacin daily"
10777373|NCT00588770|BG000|Baseline|Chemotherapy Arm (Arm A)|"ARM A: Patients receive one of the four chemotherapy regimens~ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10777374|NCT00588770|BG001|Baseline|Chemotherapy+Bevacizumab (Arm B)|"ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A~ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.~ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.~ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.~ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA."
10777375|NCT00588770|BG002|Baseline|Total|Total of all reporting groups
10800948|NCT03317496|OG003|Outcome|Phase 1b Lead-in: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11193163|NCT02143102|OG000|Outcome|Testing Set|Data from subjects in the testing set will be used to assess the study endpoints.
11193164|NCT02143102|OG001|Outcome|Full|Pooled results for final estimation
11378685|NCT02720016|FG000|Participant Flow|CBCT-Home Based (CBCT-HB)|"Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).~CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT)."
11378686|NCT02720016|FG001|Participant Flow|CBCT-Office Based (CBCT-OB)|"Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.~CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office."
11378687|NCT02720016|FG002|Participant Flow|PTSD Family Education (PFE)|"Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.~PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office."
11378688|NCT02720016|OG000|Outcome|CBCT-Home Based (CBCT-HB)|"Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).~CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT)."
11378689|NCT02720016|OG001|Outcome|CBCT-Office Based (CBCT-OB)|"Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.~CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office."
11378690|NCT02720016|OG002|Outcome|PTSD Family Education (PFE)|"Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.~PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office."
11378691|NCT02720016|OG002|Outcome|PTSD Family Education (PFE)|"Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.~PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office."
11378692|NCT02720016|EG000|Reported Event|CBCT-Home Based (CBCT-HB)|"Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).~CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT)."
10777376|NCT00588770|FG000|Participant Flow|Chemotherapy Arm (Arm A)|"ARM A: Patients receive one of the four chemotherapy regimens~ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11193165|NCT02143102|EG000|Reported Event|Development Set|Data from subjects in the training set will be utilized to further develop the vascuCAP measurements.
10777377|NCT00588770|FG001|Participant Flow|Chemotherapy+Bevacizumab (Arm B)|"ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A~ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.~ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.~ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.~ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA."
10777378|NCT00588770|OG000|Outcome|Chemotherapy Arm (Arm A)|"ARM A: Patients receive one of the four chemotherapy regimens~ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10777379|NCT00588770|OG001|Outcome|Chemotherapy+Bevacizumab (Arm B)|"ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A~ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.~ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.~Regimen 2:~ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.~Regimen 2 carbo:~ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA."
10777380|NCT00588770|EG000|Reported Event|Chemotherapy (Arm A)|"ARM A: Patients receive one of the four chemotherapy regimens~ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10777381|NCT00588770|EG001|Reported Event|Chemotherapy + Bevacizumab (Arm B)|"ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A~ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.~ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.~ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.~ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA."
10964395|NCT00877058|BG000|Baseline|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
10964396|NCT00877058|BG001|Baseline|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
11193166|NCT02143102|EG001|Reported Event|Testing Set|Data from subjects in the testing set will be used to assess the study endpoints.
11193167|NCT02143141|BG000|Baseline|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
10777386|NCT02983617|BG000|Baseline|Tirabrutinib + Entospletinib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks.
10777387|NCT02983617|BG001|Baseline|Tirabrutinib + Entospletinib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously on Day 1 of Weeks 2, 3, 5, 9, 13, 17 and 21.
10777388|NCT02983617|BG002|Baseline|Total|Total of all reporting groups
10777389|NCT02983617|FG000|Participant Flow|Tirabrutinib + Entospletinib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks.
10777390|NCT02983617|FG001|Participant Flow|Tirabrutinib + Entospletinib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously on Day 1 of Weeks 2, 3, 5, 9, 13, 17 and 21.
10777391|NCT02983617|OG000|Outcome|Tirabrutinib + Entospletinib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks.
10777392|NCT02983617|OG001|Outcome|Tirabrutinib + Entospletinib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously on Day 1 of Weeks 2, 3, 5, 9, 13, 17 and 21.
10777393|NCT02983617|EG000|Reported Event|Tirabrutinib + Entospletinib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks.
10777394|NCT02983617|EG001|Reported Event|Tirabrutinib + Entospletinib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + entospletinib 400 mg (2 x 200 mg tablets) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously on Day 1 of Weeks 2, 3, 5, 9, 13, 17 and 21.
10777395|NCT02964377|BG000|Baseline|Cohort 1|(+)- Epicatechin at 25mg/day twice per day
10777396|NCT02964377|BG001|Baseline|Cohort 2|(+)- Epicatechin at 25mg/day three times per day
10777397|NCT02964377|BG002|Baseline|Cohort 3|(+)- Epicatechin at 75mg/day at two times per day.
10777398|NCT02964377|BG003|Baseline|Total|Total of all reporting groups
10777399|NCT02964377|FG000|Participant Flow|Cohort 1|(+)- Epicatechin at 25mg/day twice per day
10777400|NCT02964377|FG001|Participant Flow|Cohort 2|(+)- Epicatechin at 25mg/day three times per day
10777401|NCT02964377|FG002|Participant Flow|Cohort 3|(+)- Epicatechin at 75mg/day at two times per day.
10777402|NCT02964377|OG000|Outcome|Cohort 1|8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
10777403|NCT02964377|OG001|Outcome|Cohort 2|8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
10777404|NCT02964377|OG002|Outcome|Cohort 3|8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
10777405|NCT02964377|EG000|Reported Event|Cohort 1|8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
10777406|NCT02964377|EG001|Reported Event|Cohort 2|8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
10777407|NCT02964377|EG002|Reported Event|Cohort 3|8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
10777408|NCT02790034|BG000|Baseline|Sarizotan Low Dose|"2 mg or 5 mg bid based on age and weight criteria for 24 wks DB~2 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~5 mg bid (≥13 years of age and weighing ≥25 kg)"
10777409|NCT02790034|BG001|Baseline|Sarizotan High Dose|"5 mg or 10 mg bid based on age and weight criteria for 24 wks DB~5 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~10 mg bid (≥13 years of age and weighing ≥25 kg)"
10777410|NCT02790034|BG002|Baseline|Placebo|Placebo BID
10777411|NCT02790034|BG003|Baseline|Total|Total of all reporting groups
10777412|NCT02790034|FG000|Participant Flow|Sarizotan Low Dose|"2 mg or 5 mg bid based on age and weight criteria for 24 wks DB~2 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~5 mg bid (≥13 years of age and weighing ≥25 kg)"
10777413|NCT02790034|FG001|Participant Flow|Sarizotan High Dose|"5 mg or 10 mg bid based on age and weight criteria for 24 wks DB~5 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~10 mg bid (≥13 years of age and weighing ≥25 kg)"
10777414|NCT02790034|FG002|Participant Flow|Placebo|Placebo bid for 24 wks DB
10777415|NCT02790034|OG000|Outcome|Sarizotan Low Dose|"2 mg or 5 mg bid based on age and weight criteria for 24 wks DB~2 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~5 mg bid (≥13 years of age and weighing ≥25 kg)"
10777416|NCT02790034|OG001|Outcome|Sarizotan High Dose|"5 mg or 10 mg bid based on age and weight criteria for 24 wks DB~5 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~10 mg bid (≥13 years of age and weighing ≥25 kg)"
10777417|NCT02790034|OG002|Outcome|Placebo|Placebo BID
10777418|NCT02790034|EG000|Reported Event|Sarizotan Low Dose|"2 mg or 5 mg bid based on age and weight criteria for 24 wks DB~2 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~5 mg bid (≥13 years of age and weighing ≥25 kg)~Assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients."
10777419|NCT02790034|EG001|Reported Event|Sarizotan High Dose|"5 mg or 10 mg bid based on age and weight criteria for 24 wks DB~5 mg bid (4 to <13 years; ≥13 years of age and weighing <25 kg~10 mg bid (≥13 years of age and weighing ≥25 kg)~Assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients."
10777420|NCT02790034|EG002|Reported Event|Placebo|"Placebo bid respectively~Placebo: placebo BID followed by assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients."
10777421|NCT02649946|BG000|Baseline|Covera Vascular Covered Stent Following PTA|"Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)~Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent."
10777422|NCT02649946|BG001|Baseline|PTA Only Using Uncoated PTA Balloon|"Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only"
10777423|NCT02649946|BG002|Baseline|Total|Total of all reporting groups
10777424|NCT02649946|FG000|Participant Flow|Covera Vascular Covered Stent Following PTA|"Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)~Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent."
10777425|NCT02649946|FG001|Participant Flow|PTA Only Using Uncoated PTA Balloon|"Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only"
10777426|NCT02649946|OG000|Outcome|Covera Vascular Covered Stent Following PTA|"Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)~Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent."
10777427|NCT02649946|OG001|Outcome|PTA Only Using Uncoated PTA Balloon|"Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only"
10777428|NCT02649946|EG000|Reported Event|Covera Vascular Covered Stent Following PTA|"Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)~Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent."
10777429|NCT02649946|EG001|Reported Event|PTA Only Using Uncoated PTA Balloon|"Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only"
10777430|NCT02431247|BG000|Baseline|D/C/F/TAF (Test) (Baseline to End of Extension [EOE])|Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.
10777431|NCT02431247|BG001|Baseline|DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)|Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
10777432|NCT02431247|BG002|Baseline|Total|Total of all reporting groups
10777433|NCT02431247|FG000|Participant Flow|D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])|Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.
10777434|NCT02431247|FG001|Participant Flow|DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)|Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
10777435|NCT02431247|FG002|Participant Flow|Switch to D/C/F/TAF|After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
10777436|NCT02431247|OG000|Outcome|D/C/F/TAF (Test) (Baseline to End of Extension [EOE])|Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.
10777437|NCT02431247|OG001|Outcome|DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)|Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
10777438|NCT02431247|OG002|Outcome|Switch to D/C/F/TAF|After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
10777439|NCT02431247|OG000|Outcome|Darunavir 800 mg [D/C/F/TAF]|Participants received DRV 800 mg along with COBI 150 mg, FTC 200 mg, TAF 10 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48.
10777440|NCT02431247|OG000|Outcome|Darunavir 800 mg [D/C/F/TAF (Test)]|Participants received DRV 800 mg along with COBI 150 mg, FTC 200 mg, TAF 10 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48.
10777441|NCT02431247|OG000|Outcome|Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)]|Participants received TAF 10 mg along with DRV 800 mg, COBI 150 mg, FTC 200 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48.
10777442|NCT02431247|OG001|Outcome|Switch to D/C/F/TAF|After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
10777443|NCT02431247|EG000|Reported Event|D/C/F/TAF+ FTC/TDF (Test)|Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.
10777444|NCT02431247|EG001|Reported Event|DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)|Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
10777445|NCT02431247|EG002|Reported Event|Switch to D/C/F/TAF Group|After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
10777446|NCT02345850|BG000|Baseline|CD34 Selected Graft|"Mobilized CD34-selected Peripheral Blood Stem Cell graft~Following screening and enrollment, the donor of patients randomized to the CD34-selection arm will receive mobilization therapy with once daily Granulocyte Colony Stimulating Factor (G-CSF). Mobilization will begin on Day -5 prior to the patient's transplant date.~Leukapheresis will be performed on a continuous flow cell separator according to institutional standards and will commence on the morning of the fifth day of G-CSF treatment. The anti-coagulant used for the procedure will be acid citrate dextrose (ACD).~Decisions concerning the need for further product collection will be based on the known or projected enriched CD34+ cell content of the previously collected products.~Mobilized CD34-selected Peripheral Blood Stem Cell graft: Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated."
10777447|NCT02345850|BG001|Baseline|Post-Transplant Cyclophosphamide|"Unmanipulated Bone Marrow Graft with Cyclophosphamide~Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.~Cyclophosphamide: Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.~Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
10777448|NCT02345850|BG002|Baseline|Tacrolimus/Methotrexate Control|"Unmanipulated bone marrow graft with Tacrolimus/Methotrexate (Tac/MTX) GVHD prophylaxis. Tac will be maintained at therapeutic doses for a minimum of 90 days. Cyclosporine may be substituted for Tac if the patient is intolerant of tacrolimus or per institutional practice. MTX will be dosed at 10-15mg/m^2 for a maximum of 4 doses post-transplant.~Tac will be given orally or intravenously per institutional standards starting Day -3. The dose of Tac may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of Tac (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tac taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.~MTX will be administered at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of MTX should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices."
10777449|NCT02345850|BG003|Baseline|Total|Total of all reporting groups
10777450|NCT02345850|FG000|Participant Flow|CD34 Selected Graft|"Mobilized CD34-selected Peripheral Blood Stem Cell graft~Following screening and enrollment, the donor of patients randomized to the CD34-selection arm will receive mobilization therapy with once daily Granulocyte Colony Stimulating Factor (G-CSF). Mobilization will begin on Day -5 prior to the patient's transplant date.~Leukapheresis will be performed on a continuous flow cell separator according to institutional standards and will commence on the morning of the fifth day of G-CSF treatment. The anti-coagulant used for the procedure will be acid citrate dextrose (ACD).~Decisions concerning the need for further product collection will be based on the known or projected enriched CD34+ cell content of the previously collected products.~Mobilized CD34-selected Peripheral Blood Stem Cell graft: Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated."
11378693|NCT02720016|EG001|Reported Event|CBCT-Office Based (CBCT-OB)|"Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.~CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office."
11378694|NCT02720016|EG002|Reported Event|PTSD Family Education (PFE)|"Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office.~PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office."
11378695|NCT02607956|BG000|Baseline|B/F/TAF|"Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food~Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first."
11378696|NCT02607956|BG001|Baseline|DTG + F/TAF|"Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food~Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first."
11378697|NCT02607956|BG002|Baseline|Total|Total of all reporting groups
11378698|NCT02607956|FG000|Participant Flow|B/F/TAF|Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.
11378699|NCT02607956|FG001|Participant Flow|DTG + F/TAF|DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks without regard to food.
11378700|NCT02607956|FG002|Participant Flow|B/F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378701|NCT02607956|FG003|Participant Flow|DTG + F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378702|NCT02607956|OG000|Outcome|B/F/TAF|Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
11378703|NCT02607956|OG001|Outcome|DTG + F/TAF|Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
11378704|NCT02607956|OG000|Outcome|All B/F/TAF|"Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.~Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first."
11378705|NCT02607956|OG001|Outcome|DTG + F/TAF to B/F/TAF|Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378706|NCT02607956|OG001|Outcome|DTG + F/TAF to B/F/TAF|Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378707|NCT02607956|OG000|Outcome|All B/F/TAF|"Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food~Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first."
11378708|NCT02607956|EG000|Reported Event|B/F/TAF|Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
11378709|NCT02607956|EG001|Reported Event|DTG + F/TAF|Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
11378710|NCT02607956|EG002|Reported Event|B/F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378711|NCT02607956|EG003|Reported Event|DTG + F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11378712|NCT02564523|BG000|Baseline|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval|Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378713|NCT02564523|BG001|Baseline|Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378714|NCT02564523|BG002|Baseline|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378715|NCT02564523|BG003|Baseline|Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval|Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378716|NCT02564523|BG004|Baseline|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
11378717|NCT02564523|BG005|Baseline|Cohort 1: Placebo, Placebo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
11378718|NCT02564523|BG006|Baseline|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378719|NCT02564523|BG007|Baseline|Cohort 2a: Placebo, Placebo, 28-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378720|NCT02564523|BG008|Baseline|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378721|NCT02564523|BG009|Baseline|Cohort 2a: Placebo, Placebo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378722|NCT02564523|BG010|Baseline|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378723|NCT02564523|BG011|Baseline|Cohort 2b: Placebo, Placebo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378724|NCT02564523|BG012|Baseline|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378725|NCT02564523|BG013|Baseline|Cohort 2b: Placebo, Placebo, 56-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378726|NCT02564523|BG014|Baseline|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378727|NCT02564523|BG015|Baseline|Cohort 3: Placebo, Placebo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
10777451|NCT02345850|FG001|Participant Flow|Post-Transplant Cyclophosphamide|"Unmanipulated Bone Marrow Graft with Cyclophosphamide~Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.~Cyclophosphamide: Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.~Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
10777452|NCT02345850|FG002|Participant Flow|Tacrolimus/Methotrexate Control|"Unmanipulated bone marrow graft with Tacrolimus/Methotrexate (Tac/MTX) GVHD prophylaxis. Tac will be maintained at therapeutic doses for a minimum of 90 days. Cyclosporine may be substituted for Tac if the patient is intolerant of tacrolimus or per institutional practice. MTX will be dosed at 10-15mg/m^2 for a maximum of 4 doses post-transplant.~Tac will be given orally or intravenously per institutional standards starting Day -3. The dose of Tac may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of Tac (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tac taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.~MTX will be administered at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of MTX should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices."
10777453|NCT02345850|OG000|Outcome|CD34 Selected Graft|"Mobilized CD34-selected Peripheral Blood Stem Cell graft~Following screening and enrollment, the donor of patients randomized to the CD34-selection arm will receive mobilization therapy with once daily Granulocyte Colony Stimulating Factor (G-CSF). Mobilization will begin on Day -5 prior to the patient's transplant date.~Leukapheresis will be performed on a continuous flow cell separator according to institutional standards and will commence on the morning of the fifth day of G-CSF treatment. The anti-coagulant used for the procedure will be acid citrate dextrose (ACD).~Decisions concerning the need for further product collection will be based on the known or projected enriched CD34+ cell content of the previously collected products.~Mobilized CD34-selected Peripheral Blood Stem Cell graft: Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated."
10777454|NCT02345850|OG001|Outcome|Post-Transplant Cyclophosphamide|"Unmanipulated Bone Marrow Graft with Cyclophosphamide~Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.~Cyclophosphamide: Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.~Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
10777455|NCT02345850|OG002|Outcome|Tacrolimus/Methotrexate Control|"Unmanipulated bone marrow graft with Tacrolimus/Methotrexate (Tac/MTX) GVHD prophylaxis. Tac will be maintained at therapeutic doses for a minimum of 90 days. Cyclosporine may be substituted for Tac if the patient is intolerant of tacrolimus or per institutional practice. MTX will be dosed at 10-15mg/m^2 for a maximum of 4 doses post-transplant.~Tac will be given orally or intravenously per institutional standards starting Day -3. The dose of Tac may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of Tac (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tac taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.~MTX will be administered at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of MTX should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices."
10850889|NCT04262947|EG002|Reported Event|Constant Imaging With VeinViewer|"Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement"
10850890|NCT04177680|BG000|Baseline|Total Study Population|All patients received both treatments
11193168|NCT02143141|BG001|Baseline|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11193169|NCT02143141|BG002|Baseline|Total|Total of all reporting groups
10777456|NCT02345850|EG000|Reported Event|CD34 Selected Graft|"Mobilized CD34-selected Peripheral Blood Stem Cell graft~Following screening and enrollment, the donor of patients randomized to the CD34-selection arm will receive mobilization therapy with once daily Granulocyte Colony Stimulating Factor (G-CSF). Mobilization will begin on Day -5 prior to the patient's transplant date.~Leukapheresis will be performed on a continuous flow cell separator according to institutional standards and will commence on the morning of the fifth day of G-CSF treatment. The anti-coagulant used for the procedure will be acid citrate dextrose (ACD).~Decisions concerning the need for further product collection will be based on the known or projected enriched CD34+ cell content of the previously collected products.~Mobilized CD34-selected Peripheral Blood Stem Cell graft: Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated."
10777457|NCT02345850|EG001|Reported Event|Post-Transplant Cyclophosphamide|"Unmanipulated Bone Marrow Graft with Cyclophosphamide~Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.~Cyclophosphamide: Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.~Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
10777458|NCT02345850|EG002|Reported Event|Tacrolimus/Methotrexate Control|"Unmanipulated bone marrow graft with Tacrolimus/Methotrexate (Tac/MTX) GVHD prophylaxis. Tac will be maintained at therapeutic doses for a minimum of 90 days. Cyclosporine may be substituted for Tac if the patient is intolerant of tacrolimus or per institutional practice. MTX will be dosed at 10-15mg/m^2 for a maximum of 4 doses post-transplant.~Tac will be given orally or intravenously per institutional standards starting Day -3. The dose of Tac may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of Tac (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tac taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.~MTX will be administered at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of MTX should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices."
10777459|NCT02343302|BG000|Baseline|Soft Pancreatic Gland|"This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777460|NCT02343302|BG001|Baseline|Hard Pancreatic Gland|"This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777461|NCT02343302|BG002|Baseline|Total|Total of all reporting groups
10777462|NCT02343302|FG000|Participant Flow|Soft Pancreatic Gland|"This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10850891|NCT04177680|FG000|Participant Flow|MAT9001 Then Vascepa|"2g MAT9001 capsules twice daily with meals for 4 weeks; 4 week washout; 2 g Vascepa (icosapent ethyl) twice daily with meals for 4 weeks~Crossover design - Patients in this arm received initial treatment with MAT9001, a washout period, and treatment with Vascepa"
11193170|NCT02143141|FG000|Participant Flow|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11378728|NCT02564523|BG016|Baseline|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378729|NCT02564523|BG017|Baseline|Cohort 3: Placebo, Placebo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378730|NCT02564523|BG018|Baseline|Total|Total of all reporting groups
11378731|NCT02564523|FG000|Participant Flow|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval|Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378732|NCT02564523|FG001|Participant Flow|Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378733|NCT02564523|FG002|Participant Flow|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378734|NCT02564523|FG003|Participant Flow|Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval|Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378735|NCT02564523|FG004|Participant Flow|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
11378736|NCT02564523|FG005|Participant Flow|Cohort 1: Placebo, Placebo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
10803656|NCT02846532|BG001|Baseline|Rivaroxaban (Part B)|Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
11378737|NCT02564523|FG006|Participant Flow|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378738|NCT02564523|FG007|Participant Flow|Cohort 2a: Placebo, Placebo, 28-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378739|NCT02564523|FG008|Participant Flow|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378740|NCT02564523|FG009|Participant Flow|Cohort 2a: Placebo, Placebo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378741|NCT02564523|FG010|Participant Flow|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378742|NCT02564523|FG011|Participant Flow|Cohort 2b: Placebo, Placebo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378743|NCT02564523|FG012|Participant Flow|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378744|NCT02564523|FG013|Participant Flow|Cohort 2b: Placebo, Placebo, 56-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378745|NCT02564523|FG014|Participant Flow|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378746|NCT02564523|FG015|Participant Flow|Cohort 3: Placebo, Placebo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378747|NCT02564523|FG016|Participant Flow|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378748|NCT02564523|FG017|Participant Flow|Cohort 3: Placebo, Placebo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378749|NCT02564523|OG000|Outcome|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval|Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378750|NCT02564523|OG001|Outcome|Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
10777463|NCT02343302|FG001|Participant Flow|Hard Pancreatic Gland|"This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777464|NCT02343302|OG000|Outcome|Soft Pancreatic Gland|"This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777465|NCT02343302|OG001|Outcome|Hard Pancreatic Gland|"This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777466|NCT02343302|EG000|Reported Event|Soft Pancreatic Gland|"This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10777467|NCT02343302|EG001|Reported Event|Hard Pancreatic Gland|"This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.~Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain~Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
10803657|NCT02846532|BG002|Baseline|Aspirin (Part B)|Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
10803658|NCT02846532|BG003|Baseline|Total|Total of all reporting groups
11339689|NCT03635086|EG004|Reported Event|Group E: One MV-CHIK Liquid Frozen High Dose|Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
10777485|NCT02053584|BG000|Baseline|Dario BGMS|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777486|NCT02053584|FG000|Participant Flow|Dario BGMS|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777487|NCT02053584|OG000|Outcome|Dario BGMS|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777488|NCT02053584|OG000|Outcome|Dario BGMS (Easily Understood)|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were easily understood.~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777489|NCT02053584|OG001|Outcome|Dario BGMS (Understood After Few Attempts)|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were understood after few attempts.~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777490|NCT02053584|OG002|Outcome|Dario BGMS (Did Not Understand How to Use)|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were not clear and that they did not understand how to use.~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777491|NCT02053584|EG000|Reported Event|Dario BGMS|"Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample~YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy."
10777492|NCT01962792|BG000|Baseline|Cohort 1 (560 mg)|"Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2~Ibrutinib~Carfilzomib"
10777493|NCT01962792|BG001|Baseline|Cohort 2a (560 mg)|"Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2~Ibrutinib~Carfilzomib"
10777494|NCT01962792|BG002|Baseline|Cohort 2b (560 mg)|"Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777495|NCT01962792|BG003|Baseline|All RP2D (840 mg)|"Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777496|NCT01962792|BG004|Baseline|Total|Total of all reporting groups
10777497|NCT01962792|FG000|Participant Flow|Cohort 1 (560 mg)|"Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2~Ibrutinib~Carfilzomib"
10777498|NCT01962792|FG001|Participant Flow|Cohort 2a (560 mg)|"Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2~Ibrutinib~Carfilzomib"
10777499|NCT01962792|FG002|Participant Flow|Cohort 2b (560 mg)|"Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777500|NCT01962792|FG003|Participant Flow|All RP2D (840 mg)|"Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
11193171|NCT02143141|FG001|Participant Flow|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11193172|NCT02143141|OG000|Outcome|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11193173|NCT02143141|OG001|Outcome|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11193174|NCT02143141|EG000|Reported Event|Duramorph|"duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours~duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
11193175|NCT02143141|EG001|Reported Event|no Duramorph|"no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively~placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching."
10777501|NCT01962792|OG000|Outcome|Cohort 1 (560 mg)|"Ibrutinib PO 560 mg + Carfilzomib IV 20/27 mg/m2~Ibrutinib~Carfilzomib"
10777502|NCT01962792|OG001|Outcome|Cohort 2a (560 mg)|"Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2~Ibrutinib~Carfilzomib"
10777503|NCT01962792|OG002|Outcome|Cohort 2b (560 mg)|"Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
11193176|NCT02143310|BG000|Baseline|EVP Users|"Subjects who switch to use the EVP for up to 2 years~EVP"
11193177|NCT02143310|FG000|Participant Flow|EVP Users|"Subject who switch to use the electronic vapour product (EVP) for up to 2 years~EVP"
11193178|NCT02143310|OG000|Outcome|EVP Users|"Subjects who use the EVP~EVP"
11193179|NCT02143310|EG000|Reported Event|EVP Users|"Subjects who use the EVP~EVP"
10777504|NCT01962792|OG003|Outcome|All RP2D (840 mg)|"Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777505|NCT01962792|OG000|Outcome|All RP2D (840 mg)|"Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777506|NCT01962792|EG000|Reported Event|Cohort 1 (560 mg)|"Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2~Ibrutinib~Carfilzomib"
10777507|NCT01962792|EG001|Reported Event|Cohort 2a (560 mg)|"Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2~Ibrutinib~Carfilzomib"
10777508|NCT01962792|EG002|Reported Event|Cohort 2b (560 mg)|"Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777509|NCT01962792|EG003|Reported Event|All RP2D (840 mg)|"Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg~Ibrutinib~Carfilzomib~Dexamethasone"
10777510|NCT01878500|BG000|Baseline|Intraoperative Stereotactic Imaging|"Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.~Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery."
10777511|NCT01878500|FG000|Participant Flow|Intraoperative Stereotactic Imaging|"Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.~Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery."
10850892|NCT04177680|FG001|Participant Flow|Vascepa Then MAT9001|"2g Vascepa (icosapent ethyl) twice daily with meals for 4 weeks; 4 week washout; MAT9001 2g twice daily with meals for 4 weeks~Crossover design - Patients were randomized to receive initial treatment with Vascepa, a washout period, and treatment with MAT9001"
10850893|NCT04177680|OG000|Outcome|Omega-3 Pentaenoic Acid (MAT9001)|"2g MAT9001 capsules twice daily with meals~Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid"
10777512|NCT01878500|OG000|Outcome|Intraoperative Stereotactic Imaging|"Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.~Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery."
10777513|NCT01878500|EG000|Reported Event|Intraoperative Stereotactic Imaging|"Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.~Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery."
10777514|NCT01464164|BG000|Baseline|Sotatercept Cohort 1|Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777515|NCT01464164|BG001|Baseline|Sotatercept Cohort 2|Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777516|NCT01464164|BG002|Baseline|Sotatercept Cohort 3|Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777517|NCT01464164|BG003|Baseline|Sotatercept With Prednisone Boost Cohort 4a|Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events
10777518|NCT01464164|BG004|Baseline|Sotatercept Cohort 4b|Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777519|NCT01464164|BG005|Baseline|Sotatercept With Prednisone Boost Cohort 5a|Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events
10777520|NCT01464164|BG006|Baseline|Sotatercept Cohort 5b|Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777521|NCT01464164|BG007|Baseline|Total|Total of all reporting groups
10777522|NCT01464164|FG000|Participant Flow|Sotatercept Cohort 1|Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777523|NCT01464164|FG001|Participant Flow|Sotatercept Cohort 2|Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777524|NCT01464164|FG002|Participant Flow|Sotatercept Cohort 3|Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
11193180|NCT02143583|BG000|Baseline|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
10777525|NCT01464164|FG003|Participant Flow|Sotatercept With Prednisone Boost Cohort 4a|Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events
10777526|NCT01464164|FG004|Participant Flow|Sotatercept Cohort 4b|Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777527|NCT01464164|FG005|Participant Flow|Sotatercept With Prednisone Boost Cohort 5a|Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events
10777528|NCT01464164|FG006|Participant Flow|Sotatercept Cohort 5b|Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777529|NCT01464164|OG000|Outcome|Sotatercept Cohort 1|Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777530|NCT01464164|OG001|Outcome|Sotatercept Cohort 2|Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777531|NCT01464164|OG002|Outcome|Sotatercept Cohort 3|Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777532|NCT01464164|OG003|Outcome|Sotatercept With Prednisone Boost Cohort 4a|Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events
10777533|NCT01464164|OG004|Outcome|Sotatercept Cohort 4b|Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777534|NCT01464164|OG005|Outcome|Sotatercept With Prednisone Boost Cohort 5a|Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events
10777535|NCT01464164|OG006|Outcome|Sotatercept Cohort 5b|Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10850894|NCT04177680|OG001|Outcome|Icosapent Ethyl (Vascepa)|"2g Vascepa capsules twice daily with meals~icosapent ethyl: Encapsulated omega-3 acid ethyl esters"
11193181|NCT02143583|BG001|Baseline|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
11193182|NCT02143583|BG002|Baseline|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
11193183|NCT02143583|BG003|Baseline|Total|Total of all reporting groups
10777536|NCT01464164|EG000|Reported Event|Sotatercept Cohort 1|Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777537|NCT01464164|EG001|Reported Event|Sotatercept Cohort 2|Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777538|NCT01464164|EG002|Reported Event|Sotatercept Cohort 3|Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events
10777539|NCT01464164|EG003|Reported Event|Sotatercept With Prednisone Boost Cohort 4a|Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events
10777540|NCT01464164|EG004|Reported Event|Sotatercept Cohort 4b|Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777541|NCT01464164|EG005|Reported Event|Sotatercept With Prednisone Boost Cohort 5a|Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events
10777542|NCT01464164|EG006|Reported Event|Sotatercept Cohort 5b|Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
10777543|NCT01318317|BG000|Baseline|Dose Level 0 (25 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777544|NCT01318317|BG001|Baseline|Dose Level 1 (50 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777545|NCT01318317|BG002|Baseline|Dose Level 2 (100 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777546|NCT01318317|BG003|Baseline|Total|Total of all reporting groups
11193184|NCT02143583|FG000|Participant Flow|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
10777547|NCT01318317|FG000|Participant Flow|Dose Level 0 (25 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777548|NCT01318317|FG001|Participant Flow|Dose Level 1 (50 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777549|NCT01318317|FG002|Participant Flow|Dose Level 2 (100 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. All patients receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777550|NCT01318317|OG000|Outcome|Dose Level 0 (25 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777551|NCT01318317|OG001|Outcome|Dose Level 1 (50 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
11193185|NCT02143583|FG001|Participant Flow|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
10777552|NCT01318317|OG002|Outcome|Dose Level 2 (100 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777553|NCT01318317|OG000|Outcome|Treatment (Cellular Adoptive Immunotherapy Following PBSCT)|"Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.~peripheral blood stem cell transplantation (PBSCT): Undergo autologous PBSCT~filgrastim: Given IV~polymerase chain reaction: Correlative studies~rituximab: Given IV~genetically engineered lymphocyte therapy: Receive ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR)~laboratory biomarker analysis: Correlative studies~plerixafor: Given IV~autologous hematopoietic stem cell transplantation: Undergo autologous PBSCT"
10777554|NCT01318317|EG000|Reported Event|Dose Level 0 (25 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777555|NCT01318317|EG001|Reported Event|Dose Level 1 (50 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777556|NCT01318317|EG002|Reported Event|Dose Level 2 (100 x 10^6 CAR+ T-cells)|Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation.
10777557|NCT01111565|BG000|Baseline|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
10777558|NCT01111565|FG000|Participant Flow|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
10777559|NCT01111565|FG001|Participant Flow|Phase B+: Single-blind Phase B Responders|Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of <14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of <3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
10777560|NCT01111565|FG002|Participant Flow|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
10777561|NCT01111565|FG003|Participant Flow|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
10850895|NCT04177680|EG000|Reported Event|Omega-3 Pentaenoic Acid (MAT9001)|"2g MAT9001 capsules twice daily with meals~Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid"
11193186|NCT02143583|FG002|Participant Flow|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
10850896|NCT04177680|EG001|Reported Event|Icosapent Ethyl (Vascepa)|"2g Vascepa capsules twice daily with meals~icosapent ethyl: Encapsulated omega-3 acid ethyl esters"
10850897|NCT03999554|BG000|Baseline|Low Dose Sing2016 M2SR|"Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29~LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11193187|NCT02143583|OG000|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
11193188|NCT02143583|OG001|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
11240898|NCT02482675|FG016|Participant Flow|Whey Protein, Then Milk, Then Glucose, Then Sodium Caseinate|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240899|NCT02482675|FG017|Participant Flow|Sodium Caseinate, Then Glucose, Then Milk, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240900|NCT02482675|FG018|Participant Flow|Sodium Caseinate, Then Whey Protein, Then Milk, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240901|NCT02482675|FG019|Participant Flow|Sodium Caseinate, Then Milk, Then Glucose, Then Whey Protein|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240902|NCT02482675|FG020|Participant Flow|Sodium Caseinate, Then Whey Protein, Then Glucose, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240903|NCT02482675|FG021|Participant Flow|Sodium Caseinate, Then Milk, Then Whey Protein, Then Glucose|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240904|NCT02482675|FG022|Participant Flow|Sodium Caseinate, Then Glucose, Then Whey Protein, Then Milk|"Each study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
11240905|NCT02482675|OG000|Outcome|Glucose|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes."
11240906|NCT02482675|OG001|Outcome|Glucose With Non-fat Milk|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes."
11240907|NCT02482675|OG002|Outcome|Glucose With Whey Protein Isolate|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes."
11240908|NCT02482675|OG003|Outcome|Glucose With Sodium Caseinate|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
10777562|NCT01111565|FG004|Participant Flow|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
10777563|NCT01111565|OG000|Outcome|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
10777564|NCT01111565|OG001|Outcome|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
10777565|NCT01111565|OG002|Outcome|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
10777566|NCT01111565|EG000|Reported Event|Phase B: Single-blind Prospective Treatment Phase|Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
10777567|NCT01111565|EG001|Reported Event|Phase B+: Single-blind Phase B Responders|Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of <14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of <3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
10777568|NCT01111565|EG002|Reported Event|Phase C: Aripiprazole/Escitalopram Combination|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
10777569|NCT01111565|EG003|Reported Event|Phase C: Escitalopram Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
10777570|NCT01111565|EG004|Reported Event|Phase C: Aripiprazole Monotherapy|Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
10777571|NCT01092117|BG000|Baseline|Ovation™ Abdominal Stent Graft System|"Implant of Ovation™ Abdominal Stent Graft System~Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System"
10777572|NCT01092117|FG000|Participant Flow|Ovation™ Abdominal Stent Graft System|"Implant of Ovation™ Abdominal Stent Graft System~Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System"
10777573|NCT01092117|OG000|Outcome|Ovation™ Abdominal Stent Graft System|"Implant of Ovation™ Abdominal Stent Graft System~Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System"
10777574|NCT01092117|EG000|Reported Event|Ovation™ Abdominal Stent Graft System|"Implant of Ovation™ Abdominal Stent Graft System~Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System"
10777575|NCT00950989|BG000|Baseline|Placebo|Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777576|NCT00950989|BG001|Baseline|Brodalumab 70 mg|70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777577|NCT00950989|BG002|Baseline|Brodalumab 140 mg|140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777578|NCT00950989|BG003|Baseline|Brodalumab 210 mg|210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777579|NCT00950989|BG004|Baseline|Total|Total of all reporting groups
10777580|NCT00950989|FG000|Participant Flow|Placebo|Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777581|NCT00950989|FG001|Participant Flow|Brodalumab 70 mg|70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777582|NCT00950989|FG002|Participant Flow|Brodalumab 140 mg|140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
11240909|NCT02482675|EG000|Reported Event|Glucose|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes."
10777583|NCT00950989|FG003|Participant Flow|Brodalumab 210 mg|210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777584|NCT00950989|OG000|Outcome|Placebo|Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777585|NCT00950989|OG001|Outcome|Brodalumab 70 mg|70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777586|NCT00950989|OG002|Outcome|Brodalumab 140 mg|140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777587|NCT00950989|OG003|Outcome|Brodalumab 210 mg|210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777588|NCT00950989|OG000|Outcome|Brodalumab 70 mg|70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777589|NCT00950989|OG001|Outcome|Brodalumab 140 mg|140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777590|NCT00950989|OG002|Outcome|Brodalumab 210 mg|210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777591|NCT00950989|EG000|Reported Event|Placebo|Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777592|NCT00950989|EG001|Reported Event|Brodalumab 70 mg|70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777593|NCT00950989|EG002|Reported Event|Brodalumab 140 mg|140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexateand folic acid supplementation (at least 5 mg per week).
10777594|NCT00950989|EG003|Reported Event|Brodalumab 210 mg|210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
10777595|NCT00489307|BG000|Baseline|Intervention Group (Dexamethasone)|Dexamethasone 4 mg orally two times a day for 14 days.
11193189|NCT02143583|OG002|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
10777596|NCT00489307|BG001|Baseline|(Control Group) Placebo|Placebo by mouth (PO) twice daily for 14 days.
10777597|NCT00489307|BG002|Baseline|Total|Total of all reporting groups
10777598|NCT00489307|FG000|Participant Flow|Intervention Group (Dexamethasone)|Dexamethasone 4 mg orally two times a day for 14 days.
10777599|NCT00489307|FG001|Participant Flow|(Control Group) Placebo|Placebo by mouth (PO) twice daily for 14 days.
10777600|NCT00489307|OG000|Outcome|Intervention Group (Dexamethasone)|Dexamethasone 4 mg orally two times a day for 14 days.
10777601|NCT00489307|OG001|Outcome|(Control Group) Placebo|Placebo by mouth (PO) twice daily for 14 days.
10777602|NCT00489307|EG000|Reported Event|Intervention Group (Dexamethasone)|Dexamethasone 4 mg orally two times a day for 14 days.
10777603|NCT00489307|EG001|Reported Event|(Control Group) Placebo|Placebo by mouth (PO) twice daily for 14 days.
10777604|NCT00072410|BG000|Baseline|Cohort 1|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777605|NCT00072410|BG001|Baseline|Cohort 2|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777606|NCT00072410|BG002|Baseline|Total|Total of all reporting groups
10777607|NCT00072410|FG000|Participant Flow|Cohort 1|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777608|NCT00072410|FG001|Participant Flow|Cohort 2|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777609|NCT00072410|OG000|Outcome|Cohort 1|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777610|NCT00072410|OG001|Outcome|Cohort 2|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
11193190|NCT02143583|EG000|Reported Event|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
11193191|NCT02143583|EG001|Reported Event|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
11193192|NCT02143583|EG002|Reported Event|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
10777611|NCT00072410|EG000|Reported Event|Cohort 1|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10777612|NCT00072410|EG001|Reported Event|Cohort 2|"Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.~90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.~111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193."
10800949|NCT03317496|OG003|Outcome|Phase 1b and 2: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm.
10800950|NCT03317496|EG000|Reported Event|Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25, and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800951|NCT03317496|EG001|Reported Event|Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 800 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
10800952|NCT03317496|EG002|Reported Event|Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin|Participants with advanced NSCLC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV infusion of pemetrexed 500 mg/m^2 and carboplatin dose at AUC 5 (carboplatin dose [mg] = target AUC * GFR mL/min + 25), and maximum carboplatin dose = target AUC [mg*min/mL] * 150 mL/min) on Day 1 of each 21-day cycle. Pemetrexed/carboplatin were administered for a maximum of 4 to 6 cycles. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11193193|NCT02143648|BG000|Baseline|Nalbuphine HCl ER 60mg|"nalbuphine HCl ER tablets 60 mg BID~nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks"
11193194|NCT02143648|BG001|Baseline|Nalbuphine HCl ER 120mg|"nalbuphine HCl ER tablets 120 mg BID~nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks"
11193195|NCT02143648|BG002|Baseline|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 8 weeks"
10800953|NCT03317496|EG003|Reported Event|Phase 1b and 2: Avelumab 1200 mg + Gemcitabine/Cisplatin|Participants (cisplatin-eligible) with UC received avelumab 1200 mg as an IV infusion over 1 hour Q3W in combination with IV administration of cisplatin 70 mg/m^2 and gemcitabine 1000 mg/m^2 on Day 1 of each 21-day cycle with gemcitabine being administered on Day 1 and Day 8. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first. Participants from both Phase 1b and Phase 2 Avelumab 1200 mg + Gemcitabine/Cisplatin were included in this arm.
10800954|NCT03260894|BG000|Baseline|Pembrolizumab + Epacadostat|Pembrolizumab 200 mg administered intravenously every 3 weeks. Epacadostat 100 mg administered orally twice daily.
10800955|NCT03260894|BG001|Baseline|SoC (Sunitinib or Pazopanib)|Standard of care (SoC) (sunitinib or pazopanib monotherapy). Sunitinib 50 mg administered orally once daily. Pazopanib 800 mg administered orally once daily.
10800956|NCT03260894|BG002|Baseline|Total|Total of all reporting groups
10800957|NCT03260894|FG000|Participant Flow|Pembrolizumab + Epacadostat|Pembrolizumab 200 mg administered intravenously every 3 weeks. Epacadostat 100 mg administered orally twice daily.
10800958|NCT03260894|FG001|Participant Flow|SoC (Sunitinib or Pazopanib)|Standard of care (SoC) (sunitinib or pazopanib monotherapy). Sunitinib 50 mg administered orally once daily;4 weeks on, 2 weeks off for 6-wk cycle. Pazopanib 800 mg administered orally once daily.
10800959|NCT03260894|OG000|Outcome|Pembrolizumab + Epacadostat|Pembrolizumab 200 mg administered intravenously every 3 weeks. Epacadostat 100 mg administered orally twice daily.
11193196|NCT02143648|BG003|Baseline|Total|Total of all reporting groups
11193197|NCT02143648|FG000|Participant Flow|Nalbuphine HCl ER 60mg|"nalbuphine HCl ER tablets 60 mg BID~nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks"
11193198|NCT02143648|FG001|Participant Flow|Nalbuphine HCl ER 120mg|"nalbuphine HCl ER tablets 120 mg BID~nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks"
11193199|NCT02143648|FG002|Participant Flow|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 8 weeks"
11193200|NCT02143648|OG000|Outcome|Nalbuphine HCl ER 60mg|"nalbuphine HCl ER tablets 60 mg BID~nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks"
11193201|NCT02143648|OG001|Outcome|Nalbuphine HCl ER 120mg|"nalbuphine HCl ER tablets 120 mg BID~nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks"
11193202|NCT02143648|OG002|Outcome|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 8 weeks"
11193203|NCT02143648|EG000|Reported Event|Nalbuphine HCl ER 60mg|"nalbuphine HCl ER tablets 60 mg BID~nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks"
11193204|NCT02143648|EG001|Reported Event|Nalbuphine HCl ER 120mg|"nalbuphine HCl ER tablets 120 mg BID~nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks"
11193205|NCT02143648|EG002|Reported Event|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 8 weeks"
10777613|NCT05057923|BG000|Baseline|Generation of Neutralizing Antibody for Unvaccinated Participants|"participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.~Bacillus subtilis: Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronal virus. This product could have a vaccine like activity within the intestinal environment."
10777614|NCT05057923|FG000|Participant Flow|Generation of Neutralizing Antibody for Unvaccinated Participants|"participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.~Bacillus subtilis: Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronal virus. This product could have a vaccine like activity within the intestinal environment."
10777615|NCT05057923|OG000|Outcome|Generation of Neutralizing Antibody for Unvaccinated Participants|"participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.~Bacillus subtilis: Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronal virus. This product could have a vaccine like activity within the intestinal environment."
10777616|NCT05057923|EG000|Reported Event|Generation of Neutralizing Antibody for Unvaccinated Participants|"participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.~Bacillus subtilis: Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronal virus. This product could have a vaccine like activity within the intestinal environment."
10800960|NCT03260894|OG001|Outcome|SoC (Sunitinib or Pazopanib)|Standard of care (SoC) (sunitinib or pazopanib monotherapy). Sunitinib 50 mg administered orally once daily;4 weeks on, 2 weeks off for 6-wk cycle. Pazopanib 800 mg administered orally once daily.
10800961|NCT03260894|EG000|Reported Event|Pembrolizumab + Epacadostat|Pembrolizumab 200 mg administered intravenously every 3 weeks. Epacadostat 100 mg administered orally twice daily.
10800962|NCT03260894|EG001|Reported Event|SoC (Sunitinib or Pazopanib)|Standard of care (SoC) (sunitinib or pazopanib monotherapy). Sunitinib 50 mg administered orally once daily;4 weeks on, 2 weeks off for 6-wk cycle. Pazopanib 800 mg administered orally once daily.
10800963|NCT03215810|BG000|Baseline|TIL+ Nivolumab|Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
10800964|NCT03215810|FG000|Participant Flow|TIL+ Nivolumab|Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
10800965|NCT03215810|OG000|Outcome|TIL+ Nivolumab|Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
11193206|NCT02143713|BG000|Baseline|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
11193207|NCT02143713|BG001|Baseline|Placebo Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193208|NCT02143713|BG002|Baseline|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
11193209|NCT02143713|BG003|Baseline|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
10800966|NCT03215810|EG000|Reported Event|TIL+ Nivolumab|Nivolumab, 240 mg, IV infusion every 2 weeks for 8 weeks prior to Tumor Infiltrating Lymphocytes (TIL) infusion, and then after TIL infusion 480 mg every 4 weeks for up to 12 months
10800967|NCT03123822|BG000|Baseline|Single Vision Glasses|"Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800968|NCT03123822|BG001|Baseline|Single Vision Glasses With Anti-glare Coating|"Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800969|NCT03123822|BG002|Baseline|Eyezen|"Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours~Glasses: Glasses traditionally prescribed for refractive error"
10800970|NCT03123822|BG003|Baseline|Total|Total of all reporting groups
10800971|NCT03123822|FG000|Participant Flow|Single Vision Glasses|"Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
11193210|NCT02143713|BG004|Baseline|Total|Total of all reporting groups
11193211|NCT02143713|FG000|Participant Flow|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg once daily (QD) for 6 months in this extension Study M12-821.
11193212|NCT02143713|FG001|Participant Flow|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg twice daily (BID) for 6 months in this extension Study M12-821.
11193213|NCT02143713|FG002|Participant Flow|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
11378751|NCT02564523|OG002|Outcome|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378752|NCT02564523|OG003|Outcome|Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval|Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378753|NCT02564523|OG004|Outcome|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
11378754|NCT02564523|OG005|Outcome|Cohort 1: Placebo, Placebo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
11378755|NCT02564523|OG006|Outcome|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378756|NCT02564523|OG007|Outcome|Cohort 2a: Placebo, Placebo, 28-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378757|NCT02564523|OG008|Outcome|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378758|NCT02564523|OG009|Outcome|Cohort 2a: Placebo, Placebo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378759|NCT02564523|OG010|Outcome|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378760|NCT02564523|OG011|Outcome|Cohort 2b: Placebo, Placebo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378761|NCT02564523|OG012|Outcome|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378762|NCT02564523|OG013|Outcome|Cohort 2b: Placebo, Placebo, 56-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378763|NCT02564523|OG014|Outcome|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378764|NCT02564523|OG015|Outcome|Cohort 3: Placebo, Placebo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378765|NCT02564523|OG016|Outcome|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378766|NCT02564523|OG017|Outcome|Cohort 3: Placebo, Placebo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
10777617|NCT04632706|BG000|Baseline|50mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
10777618|NCT04632706|BG001|Baseline|75mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
10777619|NCT04632706|BG002|Baseline|100mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
10777620|NCT04632706|BG003|Baseline|Matching Placebo (Oral)|Placebo tablets matching the Active IMP
10777621|NCT04632706|BG004|Baseline|Total|Total of all reporting groups
10777622|NCT04632706|FG000|Participant Flow|50mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
10777623|NCT04632706|FG001|Participant Flow|75mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
10777624|NCT04632706|FG002|Participant Flow|100mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
10777625|NCT04632706|FG003|Participant Flow|Matching Placebo (Oral)|Placebo tablets matching the Active Investigative Medicinal Product (IMP)
10777626|NCT04632706|OG000|Outcome|50mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
11378767|NCT02564523|OG002|Outcome|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378768|NCT02564523|OG003|Outcome|Cohort 2a: Placebo, Placebo, 28-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378769|NCT02564523|OG004|Outcome|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378770|NCT02564523|OG005|Outcome|Cohort 2b: Placebo, Placebo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378771|NCT02564523|OG006|Outcome|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378772|NCT02564523|OG007|Outcome|Cohort 3: Placebo, Placebo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11193214|NCT02143713|FG003|Participant Flow|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
11378773|NCT02564523|OG000|Outcome|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378774|NCT02564523|OG001|Outcome|Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval|Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378775|NCT02564523|OG002|Outcome|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378776|NCT02564523|OG003|Outcome|Cohort 2a: Placebo, Placebo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378777|NCT02564523|OG004|Outcome|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378778|NCT02564523|OG005|Outcome|Cohort 2b: Placebo, Placebo, 56-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378779|NCT02564523|OG006|Outcome|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378780|NCT02564523|OG007|Outcome|Cohort 3: Placebo, Placebo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378781|NCT02564523|OG000|Outcome|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
11193215|NCT02143713|OG000|Outcome|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
11378782|NCT02564523|OG001|Outcome|Cohort 1: Placebo, Placebo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
11378783|NCT02564523|EG000|Reported Event|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval|Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378784|NCT02564523|EG001|Reported Event|Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378785|NCT02564523|EG002|Reported Event|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
11378786|NCT02564523|EG003|Reported Event|Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval|Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
11378787|NCT02564523|EG004|Reported Event|Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
11378788|NCT02564523|EG005|Reported Event|Cohort 1: Placebo, Placebo, 84-Day Interval|Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
11378789|NCT02564523|EG006|Reported Event|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378790|NCT02564523|EG007|Reported Event|Cohort 2a: Placebo, Placebo, 28-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378791|NCT02564523|EG008|Reported Event|Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378792|NCT02564523|EG009|Reported Event|Cohort 2a: Placebo, Placebo, 56-Day Interval|Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378793|NCT02564523|EG010|Reported Event|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378794|NCT02564523|EG011|Reported Event|Cohort 2b: Placebo, Placebo, 28-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
10777627|NCT04632706|OG001|Outcome|75mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
11378795|NCT02564523|EG012|Reported Event|Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378796|NCT02564523|EG013|Reported Event|Cohort 2b: Placebo, Placebo, 56-Day Interval|Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378797|NCT02564523|EG014|Reported Event|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
11378798|NCT02564523|EG015|Reported Event|Cohort 3: Placebo, Placebo, 28-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
11378799|NCT02564523|EG016|Reported Event|Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
11378800|NCT02564523|EG017|Reported Event|Cohort 3: Placebo, Placebo, 56-Day Interval|Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
11378801|NCT02094716|BG000|Baseline|Permethrin Foam 4%/ Permethrin Foam 4%|"First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.~Topical application, whole-body treatment"
11378802|NCT02094716|BG001|Baseline|Permethrin Foam 5%/ Permethrin Foam 5%|"First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.~Topical application, whole-body treatment"
11378803|NCT02094716|BG002|Baseline|Vehicle Foam|"First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary.~Topical application, whole-body treatment"
11378804|NCT02094716|BG003|Baseline|Total|Total of all reporting groups
11378805|NCT02094716|FG000|Participant Flow|Permethrin Foam 4%/ Permethrin Foam 4%|"First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.~Topical application, whole-body treatment"
11378806|NCT02094716|FG001|Participant Flow|Permethrin Foam 5%/ Permethrin Foam 5%|"First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.~Topical application, whole-body treatment"
11378807|NCT02094716|FG002|Participant Flow|Vehicle Foam|"First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary.~Topical application, whole-body treatment"
10777628|NCT04632706|OG002|Outcome|100mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
11378808|NCT02094716|OG000|Outcome|Permethrin Foam 4%/ Permethrin Foam 4%|"First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.~Topical application, whole-body treatment"
11378809|NCT02094716|OG001|Outcome|Permethrin Foam 5%/ Permethrin Foam 5%|"First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.~Topical application, whole-body treatment"
11378810|NCT02094716|OG002|Outcome|Vehicle Foam|"First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary.~Topical application, whole-body treatment"
11378811|NCT02094716|OG000|Outcome|Permethrin Foam 4%; Permethrin Foam 4%|"First treatment with Permethrin Foam 4% with re-treatment with Permethrin Foam 4% at Day 14 who were also improving at Day 28.~Topical application, whole-body treatment"
11378812|NCT02094716|OG001|Outcome|Permethrin Foam 5%; Permethrin Foam 5%|"First treatment with Permethrin Foam 5% with re-treatment with Permethrin Foam 5% at Day 14 who were also improving at Day 28.~Topical application, whole-body treatment"
11378813|NCT02094716|OG002|Outcome|Vehicle; Permethrin Foam 4%|"First treatment with Vehicle Foam with second treatment with Permethrin Foam 4% at Day 14 who were also improving at Day 28~Topical application, whole body treatment"
11378814|NCT02094716|OG003|Outcome|Vehicle Foam; Permethrin Foam 5%|"First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28.~Topical application, whole-body treatment"
10777629|NCT04632706|OG003|Outcome|Matching Placebo (Oral)|Placebo tablets matching the Active IMP
10777630|NCT04632706|EG000|Reported Event|50mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28.
10777631|NCT04632706|EG001|Reported Event|75mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28.
10777632|NCT04632706|EG002|Reported Event|100mcg/kg (Oral)|Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28.
11378815|NCT02094716|OG000|Outcome|Permethrin Foam 4%; Permethrin Foam 4%|"First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.~Topical application, whole-body treatment"
11378816|NCT02094716|OG001|Outcome|Permethrin Foam 5%; Permethrin Foam 5%|"First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.~Topical application, whole-body treatment"
11378817|NCT02094716|OG002|Outcome|Vehicle Foam; Permethrin Foam 4%|"First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.~Topical application, whole-body treatment"
11378818|NCT02094716|OG003|Outcome|Vehicle; Permethrin Foam 5%|"First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.~Topical application, whole-body treatment"
11378819|NCT02094716|OG000|Outcome|Permethrin Foam 4% Two Active Treatments|"First treatment with Permethrin Foam 4%, second treatment with Permethrin Foam 4%.~Topical application, whole-body treatment"
11378820|NCT02094716|OG001|Outcome|Permethrin Foam 5% Two Active Treatments|"First treatment with Permethrin Foam 5%, second treatment with Permethrin Foam 5%.~Topical application, whole-body treatment"
11378821|NCT02094716|OG002|Outcome|Permethrin Foam 4% Single Active Treatment|"If the subject was improved at Day 14 and only received one treatment (Permethrin Foam, 4%), or if the subject received Vehicle Foam at Baseline, was not improved at Day 14, and received a single active (Permethrin Foam, 4%) treatment at Day 14.~Topical application, whole-body treatment"
11193216|NCT02143713|OG001|Outcome|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193217|NCT02143713|OG002|Outcome|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
11193218|NCT02143713|OG003|Outcome|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193219|NCT02143713|OG001|Outcome|Placebo Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193220|NCT02143713|EG000|Reported Event|Placebo/Elagolix 150 mg QD|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
11193221|NCT02143713|EG001|Reported Event|Placebo/Elagolix 200 mg BID|Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193222|NCT02143713|EG002|Reported Event|Elagolix/Elagolix 150 mg QD|Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
11193223|NCT02143713|EG003|Reported Event|Elagolix/Elagolix 200 mg BID|Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
11193224|NCT02143778|BG000|Baseline|Compensated Cirrhotic Patients|"A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.~Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring"
11193225|NCT02143778|FG000|Participant Flow|Compensated Cirrhotic Patients|"A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.~Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring"
11193226|NCT02143778|OG000|Outcome|Compensated Cirrhotic Patients With CSPH|"A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.~Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring"
11193227|NCT02143778|OG000|Outcome|Compensated Cirrhotic Patients With SPH|"A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis with severe portal hypertension.~Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring"
10777633|NCT04632706|EG003|Reported Event|Matching Placebo (Oral)|Placebo tablets matching the Active IMP
11193228|NCT02143778|EG000|Reported Event|Compensated Cirrhotic Patients|"A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.~Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring"
11193229|NCT02143843|BG000|Baseline|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
11193230|NCT02143843|FG000|Participant Flow|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
11193231|NCT02143843|OG000|Outcome|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
11193232|NCT02143843|EG000|Reported Event|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
11193233|NCT02143947|BG000|Baseline|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
10777634|NCT04632706|EG004|Reported Event|Ivermectin Overall|Ivermectin loading dose of 200 mcg/kg followed by daily doses of either 50, 75, or 100mcg/kg from D2 to D28.
11193234|NCT02143947|BG001|Baseline|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
11193235|NCT02143947|BG002|Baseline|Total|Total of all reporting groups
11193236|NCT02143947|FG000|Participant Flow|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
11193237|NCT02143947|FG001|Participant Flow|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
11193238|NCT02143947|OG000|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
11193239|NCT02143947|OG001|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
11193240|NCT02143947|OG000|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
11193241|NCT02143947|OG001|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
11193242|NCT02143947|EG000|Reported Event|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
11378822|NCT02094716|OG003|Outcome|Permethrin Foam 5% Single Active Treatment|"If the subject was improved at Day 14 and only received one treatment (Permethrin Foam, 5%), or if the subject received Vehicle Foam at Baseline, was not improved at Day 14, and received a single active (Permethrin Foam, 5%) treatment at Day 14.~Topical application, whole-body treatment"
11378823|NCT02094716|EG000|Reported Event|Permethrin Foam 4%|"Treatment with Permethrin Foam 4%.~Topical application, whole-body treatment"
11378824|NCT02094716|EG001|Reported Event|Permethrin Foam 5%|"Treatment with Permethrin Foam 5%.~Topical application, whole-body treatment"
11378825|NCT02094716|EG002|Reported Event|Vehicle Foam|"Treatment with Vehicle Foam.~Topical application, whole-body treatment"
11378826|NCT01988493|BG000|Baseline|Phase 1b: Tepotinib 300 mg|Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378827|NCT01988493|BG001|Baseline|Phase 1b: Tepotinib 500 mg|Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378828|NCT01988493|BG002|Baseline|Phase 1b: Tepotinib 1000 mg|Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378829|NCT01988493|BG003|Baseline|Phase 2: Tepotinib|Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378830|NCT01988493|BG004|Baseline|Phase 2 Sorafenib|Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378831|NCT01988493|BG005|Baseline|Total|Total of all reporting groups
11378832|NCT01988493|FG000|Participant Flow|Phase 1b: Tepotinib 300 mg|Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378833|NCT01988493|FG001|Participant Flow|Phase 1b: Tepotinib 500 mg|Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378834|NCT01988493|FG002|Participant Flow|Phase 1b: Tepotinib 1000 mg|Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378835|NCT01988493|FG003|Participant Flow|Phase 2: Tepotinib|Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
10777635|NCT04632706|EG005|Reported Event|Total (Ivermectin Overall and Placebo)|All study participants
10777636|NCT04544358|BG000|Baseline|BAILAMOS©|"BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.~BAILAMOS©: BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule."
11378836|NCT01988493|FG004|Participant Flow|Phase 2 Sorafenib|Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378837|NCT01988493|OG000|Outcome|Phase 1b: Tepotinib 300 mg|Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378838|NCT01988493|OG001|Outcome|Phase 1b: Tepotinib 500 mg|Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378839|NCT01988493|OG002|Outcome|Phase 1b: Tepotinib 1000 mg|Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378840|NCT01988493|OG000|Outcome|Phase 2: Tepotinib|Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378841|NCT01988493|OG001|Outcome|Phase 2 Sorafenib|Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378842|NCT01988493|EG000|Reported Event|Phase 1b: Tepotinib 300 mg|Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378843|NCT01988493|EG001|Reported Event|Phase 1b: Tepotinib 500 mg|Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378844|NCT01988493|EG002|Reported Event|Phase 1b: Tepotinib 1000 mg|Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378845|NCT01988493|EG003|Reported Event|Phase 2: Tepotinib|Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
10777637|NCT04544358|BG001|Baseline|Control|Randomized to wait list, received BAILAMOS© program after data collection.
10777638|NCT04544358|BG002|Baseline|Total|Total of all reporting groups
11378846|NCT01988493|EG004|Reported Event|Phase 2 Sorafenib|Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
11378847|NCT01868139|BG000|Baseline|Cryotherapy|"Liquid nitrogen spray cryotherapy with the truFreeze device~Liquid nitrogen spray cryotherapy with the truFreeze device: Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place."
11378848|NCT01868139|FG000|Participant Flow|Treatment|Treated with liquid nitrogen spray cryotherapy
11378849|NCT01868139|OG000|Outcome|Treatment|Treated with liquid nitrogen spray cryotherapy
10777639|NCT04544358|FG000|Participant Flow|BAILAMOS©|"BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.~BAILAMOS©: BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule."
10777640|NCT04544358|FG001|Participant Flow|Control|Randomized to wait list, received BAILAMOS© program after data collection.
10777641|NCT04544358|OG000|Outcome|BAILAMOS©|"BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.~BAILAMOS©: BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule."
10777642|NCT04544358|OG001|Outcome|Control|Randomized to wait list, received BAILAMOS© program after data collection.
10777643|NCT04544358|EG000|Reported Event|BAILAMOS©|"BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.~BAILAMOS©: BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule."
10777644|NCT04544358|EG001|Reported Event|Control While on Waitlist|Randomized to wait list, remained on waitlist for 4 months, received BAILAMOS© program after data collection.
10777645|NCT04544358|EG002|Reported Event|Control While Participating in BAILAMOS©|Randomized to wait list, received 4-month BAILAMOS© program after data collection.
10800972|NCT03123822|FG001|Participant Flow|Single Vision Glasses With Anti-glare Coating|"Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800973|NCT03123822|FG002|Participant Flow|Eyezen|"Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours~Glasses: Glasses traditionally prescribed for refractive error"
10800974|NCT03123822|OG000|Outcome|Single Vision Glasses|"Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800975|NCT03123822|OG001|Outcome|Single Vision Glasses With Anti-glare Coating|"Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800976|NCT03123822|OG002|Outcome|Eyezen|"Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours~Glasses: Glasses traditionally prescribed for refractive error"
10800977|NCT03123822|EG000|Reported Event|Single Vision Glasses|"Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800978|NCT03123822|EG001|Reported Event|Single Vision Glasses With Anti-glare Coating|"Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.~Glasses: Glasses traditionally prescribed for refractive error"
10800979|NCT03123822|EG002|Reported Event|Eyezen|"Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours~Glasses: Glasses traditionally prescribed for refractive error"
10800980|NCT03067129|BG000|Baseline|Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs|Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
10800981|NCT03067129|BG001|Baseline|Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
10800982|NCT03067129|BG002|Baseline|Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
10800983|NCT03067129|BG003|Baseline|Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
10800984|NCT03067129|BG004|Baseline|Total|Total of all reporting groups
10800985|NCT03067129|FG000|Participant Flow|Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs|Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
10800986|NCT03067129|FG001|Participant Flow|Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
10800987|NCT03067129|FG002|Participant Flow|Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
10800988|NCT03067129|FG003|Participant Flow|Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
11378850|NCT01868139|OG000|Outcome|Cryotherapy|"Liquid nitrogen spray cryotherapy with the truFreeze device~Liquid nitrogen spray cryotherapy with the truFreeze device: Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place."
11378851|NCT01868139|EG000|Reported Event|Treatment|Treated with liquid nitrogen spray cryotherapy
11378852|NCT01798004|BG000|Baseline|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
11378853|NCT01798004|FG000|Participant Flow|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
11378854|NCT01798004|OG000|Outcome|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
11378855|NCT01798004|EG000|Reported Event|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
11378856|NCT01620658|BG000|Baseline|Standard Cap|"Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.~Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions."
11378857|NCT01620658|BG001|Baseline|0.3mm XPF Cap|"Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378858|NCT01620658|BG002|Baseline|0.5mm XPF Cap|"Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378859|NCT01620658|BG003|Baseline|Total|Total of all reporting groups
11378860|NCT01620658|FG000|Participant Flow|Standard Cap|"Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.~Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions."
11378861|NCT01620658|FG001|Participant Flow|0.3mm XPF Cap|"Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378862|NCT01620658|FG002|Participant Flow|0.5mm XPF Cap|"Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378863|NCT01620658|OG000|Outcome|Standard Cap|"Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.~Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions."
11378864|NCT01620658|OG001|Outcome|0.3mm XPF Cap|"Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378865|NCT01620658|OG002|Outcome|0.5mm XPF Cap|"Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378866|NCT01620658|OG000|Outcome|Radiation Exposure Monitored With Standard Caps.|Operators were randomly assigned to wear standard fabric Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.
11378867|NCT01620658|OG001|Outcome|Radiation Exposure Monitored With XPF 0.3 mm Caps|Operators were randomly assigned to wear the 0.3 mm Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.
11378868|NCT01620658|OG002|Outcome|Radiation Exposure Monitored With XPF 0.5mm Caps|Operators were randomly assigned to wear lead-equivalent XPF caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.
11378869|NCT01620658|OG000|Outcome|Standard Caps|Operators were randomly assigned to wear standard fabric Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
11378870|NCT01620658|OG001|Outcome|XPF 0.3 mm|Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
11378871|NCT01620658|OG002|Outcome|XPF 0.5 mm|Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
11378872|NCT01620658|OG001|Outcome|XPF 0.5 mm|Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
10777646|NCT04498247|BG000|Baseline|V591 1×10^4 TCID50-1 Dose|Participants received one dose of V591 1x10^4 TCID50 on Day 1
11378873|NCT01620658|OG002|Outcome|XPF 0.3 mm|Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
11378874|NCT01620658|EG000|Reported Event|Standard Cap|"Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.~Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions."
10777647|NCT04498247|BG001|Baseline|V591 1×10^5 TCID50- 1 Dose|Participants received one dose of V591 1×10^5 TCID50 on Day 1.
10777648|NCT04498247|BG002|Baseline|V591 1x10^5 TCID50- 2 Dose|Participants received one dose of V591 1×10^5 TCID50 on Day 1 and a second V591 1×10^5 TCID50 dose on Day 57.
11378875|NCT01620658|EG001|Reported Event|0.3mm XPF Cap|"Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378876|NCT01620658|EG002|Reported Event|0.5mm XPF Cap|"Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
11378877|NCT01447628|BG000|Baseline|European Dataset|"IV iron (1000 mg) formulation used in Europe - Ferinject - given over 15 minutes~Saline: intravenous, no active drug"
11378878|NCT01447628|BG001|Baseline|China Dataset|"IV iron (1000mg) formulation used in China - CosmoFer - over a period of 4 to 6 hours~Saline: intravenous, no active drug"
11378879|NCT01447628|BG002|Baseline|Total|Total of all reporting groups
11378880|NCT01447628|FG000|Participant Flow|Ferinject Followed by Placebo (Europe)|"IV iron formulation used in Europe - Ferinject (Intravenous, 1000 mg iron)- given over 15 minutes followed by Placebo given as 1000mg saline according to randomisation.~Ferinject administered at week 0, placebo (saline) administered at week 12."
11378881|NCT01447628|FG001|Participant Flow|Placebo Followed by Ferinject (Europe)|"IV iron formulation used in Europe - Ferinject (Intravenous, 1000 mg iron)- given over 15 minutes or Placebo given as 1000mg saline according to randomisation.~Placebo (saline) administered at week 0, Ferinject administered at week 12."
11378882|NCT01447628|FG002|Participant Flow|Cosmofer Followed by Placebo (China)|"IV iron formulation used in China was CosmoFer - given intravenously over a period of 4 to 6 hours~Cosmofer administered at week 0, placebo (saline) administered at week 12."
11378883|NCT01447628|FG003|Participant Flow|Placebo Followed by Cosmofer (China)|"IV iron formulation used in China was CosmoFer - given intravenously over a period of 4 to 6 hours~Placebo (saline) administered at week 0, Cosmofer administered at week 12."
11378884|NCT01447628|OG000|Outcome|Ferinject Group (Europe)|"IV iron formulation used in Europe - Ferinject (Intravenous, 1000 mg iron)- given over 15 minutes~This group provides the outcome measurements for participants following their infusion of Ferinject whether this was at the first or second timepoint"
11378885|NCT01447628|OG001|Outcome|Placebo Group (Europe)|"Placebo (saline) given intravenously over 15 minutes.~This group provides the outcome measurements for participants following their infusion of Placebo whether at the first or second timepoint"
11378886|NCT01447628|OG000|Outcome|Ferinject Group (Europe)|"IV iron formulation used in Europe - Ferinject (Intravenous, 1000 mg iron)- given over 15 minutes~This group provides the outcome measurements for participants following their infusion of Ferinject, whether this was at the first or second timepoint"
11378887|NCT01447628|OG001|Outcome|Placebo Group (Europe)|"Placebo (saline) given intravenously over 15 minutes.~This group provides the outcome measurements for participants following their infusion of Placebo, whether this was at the first or second timepoint"
11378888|NCT01447628|OG002|Outcome|Cosmofer Group (China)|"This group provides the outcome measurements for participants following their infusion of CosmoFer, whether this was at the first or second timepoint.~IV iron formulation used in China was CosmoFer - given intravenously over a period of 4 to 6 hours"
11378889|NCT01447628|OG003|Outcome|Placebo Group (China)|This group provides the outcome measurements for participants from the Fuwai site following their infusion of Placebo (saline, infused over 4-6hrs), whether this was at the first or second timepoint.
10777649|NCT04498247|BG003|Baseline|V591 1×10^6 TCID50-1 Dose|Participants received one dose of V591 1×10^6 TCID50 on Day 1.
10777650|NCT04498247|BG004|Baseline|V591 1×10^6 TCID50-2 Dose|Participants received one dose of V591 1×10^6 TCID50 on Day 1 and a second V591 1×10^6 TCID50 dose on Day 57.
11378890|NCT01447628|OG000|Outcome|Ferinject European Dataset: Active IMP|Measure of transferrin saturations in European patients receiving active treatment.
11378891|NCT01447628|OG001|Outcome|Ferinject European Dataset: Placebo Arm|Measure of transferrin saturations at 12 weeks in European patients receiving placebo
11378892|NCT01447628|OG002|Outcome|Cosmofer: China Dataset Active|Measure of transferrin saturations in China patients receiving Cosmofer
11378893|NCT01447628|OG003|Outcome|Placebo: China Dataset|Measure of transferrin saturations in China patients receiving Placebo
11378894|NCT01447628|OG000|Outcome|Cardiac MR Dataset: Active Treatment|This group includes all participants in the Europe and China Dataset that volunteered to the optional cardiac MR that received active treatment
11378895|NCT01447628|OG001|Outcome|Cardiac MR Dataset: Placebo|This group includes all participants in the Europe and China Dataset that volunteered to the optional cardiac MR that received Placebo
11378896|NCT01447628|EG000|Reported Event|European Dataset: Iron|"IV iron formulation used in Europe - Ferinject - given over 15 minutes~Ferinject or CosmoFer: Intravenous, 1000 mg iron~Time scale is within 12 weeks from Ferinject administration"
11378897|NCT01447628|EG001|Reported Event|European Dataset: Placebo|"Placebo was 1000mg saline: intravenous, no active drug~Time scale is within 12 weeks from saline administration"
11378898|NCT01447628|EG002|Reported Event|European Dataset: Outside Window|AEs reported before intervention or more than 12 weeks following both Iron and Placebo.
11378899|NCT01447628|EG003|Reported Event|China Dataset: Iron|"IV iron formulation used in China - CosmoFer - over a period of 4 to 6 hours~Ferinject or CosmoFer: Intravenous, 1000 mg iron~Time scale is within 12 weeks from Ferinject administration"
11378900|NCT01447628|EG004|Reported Event|China Dataset: Placebo|"Placebo was 1000mg saline: intravenous, no active drug~Time scale is within 12 weeks from saline administration"
11378901|NCT01447628|EG005|Reported Event|China Dataset: Outside Window|AEs reported before intervention or more than 12 weeks following both Iron and Placebo.
11378902|NCT01175356|BG000|Baseline|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
11378903|NCT01175356|FG000|Participant Flow|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
10777651|NCT04498247|BG005|Baseline|V591 1×10^7 TCID50|Participants received one dose of V591 1×10^7 TCID50 on Day 1
10777652|NCT04498247|BG006|Baseline|Placebo - 1 Dose|Participants received one dose of placebo on Day 1.
10777653|NCT04498247|BG007|Baseline|Placebo- 2 Dose|Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.
10777654|NCT04498247|BG008|Baseline|Total|Total of all reporting groups
10777655|NCT04498247|FG000|Participant Flow|V591 1×10^4 TCID50-1 Dose|Participants received one dose of V591 1x10^4 tissue culture infectious dose (TCID50) on Day 1
10777656|NCT04498247|FG001|Participant Flow|V591 1×10^5 TCID50-1 Dose|Participants received one dose of V591 1×10^5 TCID50 on Day 1.
10777657|NCT04498247|FG002|Participant Flow|V591 1x10^5 TCID50- 2 Dose|Participants received one dose of V591 1×10^5 TCID50 on Day 1 and a second V591 1×10^5 TCID50 dose on Day 57.
10777658|NCT04498247|FG003|Participant Flow|V591 1×10^6 TCID50-1 Dose|Participants received one dose of V591 1×10^6 TCID50 on Day 1
10777659|NCT04498247|FG004|Participant Flow|V591 1×10^6 TCID50-2 Dose|Participants received one dose of V591 1×10^6 TCID50 on Day 1 and a second V591 1×10^6 TCID50 dose on Day 57.
10777660|NCT04498247|FG005|Participant Flow|V591 1×10^7 TCID50|Participants received one dose of V591 1×10^7 TCID50 on Day 1
10777661|NCT04498247|FG006|Participant Flow|Placebo- 1 Dose|Participants received one dose of placebo on Day 1
10777662|NCT04498247|FG007|Participant Flow|Placebo- 2 Dose|Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.
10777663|NCT04498247|OG000|Outcome|V591 1×10^4 TCID50|Participants received one dose of V591 1x10^4 TCID50 on Day 1
10777664|NCT04498247|OG001|Outcome|V591 1×10^5 TCID50|All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.
10777665|NCT04498247|OG002|Outcome|V591 1×10^6 TCID50|All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.
10777666|NCT04498247|OG003|Outcome|V591 1×10^7 TCID50|Participants received one dose of V591 1×10^7 TCID50 on Day 1
10777667|NCT04498247|OG004|Outcome|Placebo|Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
10777668|NCT04498247|EG000|Reported Event|V591 1x10⁴ TCID₅₀-Post Vaccination (Vacc) 1|Participants received one dose of 1x10^4 TCID50 V591 on Day 1
10777669|NCT04498247|EG001|Reported Event|V591 1x10⁵ TCID₅₀-Post Vacc 1|All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.
10777670|NCT04498247|EG002|Reported Event|V591 1x10⁶ TCID₅₀-Post Vacc 1|All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.
10777671|NCT04498247|EG003|Reported Event|V591 1x10⁷ TCID₅₀-Post Vacc 1|Participants received one dose of V591 1×10^7 TCID50 on Day 1
10777672|NCT04498247|EG004|Reported Event|Placebo-Post Vacc 1|Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
10777673|NCT04498247|EG005|Reported Event|V591 1x10⁵ TCID₅₀-Post Vacc 2|All participants received 2 doses of V591; one dose of V591 1×10^5 TCID50 on Day 1 and a second dose of V591 1×10^5 TCID50 on Day 57.
10777674|NCT04498247|EG006|Reported Event|V591 1x10⁶ TCID₅₀-Post Vacc 2|All participants received 2 doses of V591; one dose of V591 1×10^6 TCID50 on Day 1 and a second dose of V591 1×10^6 TCID50 on Day 57.
10777675|NCT04498247|EG007|Reported Event|Placebo-Post Vacc 2|All participants received 2 doses of placebo; one dose of placebo on Day 1 and a second dose of placebo on Day 57.
10777676|NCT04472650|BG000|Baseline|Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule|Sitravatinib free base capsule 120 mg on Day 1 of Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days
10777677|NCT04472650|BG001|Baseline|Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule|Sitravatinib malate salt capsule 100 mg on Day 1 of Period 1 then sitravatinib free base capsule 120 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days
10777678|NCT04472650|BG002|Baseline|Total|Total of all reporting groups
10777679|NCT04472650|FG000|Participant Flow|Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule|Sitravatinib free base capsule 120 mg on Day 1 of Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days
10777680|NCT04472650|FG001|Participant Flow|Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule|Sitravatinib malate salt capsule 100 mg on Day 1 of Period 1 then sitravatinib free base capsule 120 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days
11240910|NCT02482675|EG001|Reported Event|Glucose With Non-fat Milk|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes."
10777681|NCT04472650|OG000|Outcome|Sitravatinib Malate Salt Capsule|Sitravatinib malate salt capsule 100 mg (test) on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777682|NCT04472650|OG001|Outcome|Sitravatinib Free Base Capsule|Sitravatinib free base capsule 120 mg (reference) on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777683|NCT04472650|OG000|Outcome|Sitravatinib Malate Salt Capsule|Sitravatinib malate salt capsule 100 mg on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777684|NCT04472650|OG001|Outcome|Sitravatinib Free Base Capsule|Sitravatinib free base capsule 120 mg on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777685|NCT04472650|EG000|Reported Event|Sitravatinib Malate Salt Capsule|Sitravatinib malate salt capsule 100 mg on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777686|NCT04472650|EG001|Reported Event|Sitravatinib Free Base Capsule|Sitravatinib free base capsule 120 mg (reference) on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days
10777687|NCT04359797|BG000|Baseline|Usual Care|"Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.~Usual Care: No provider-recommendation, patients will remain in their natural choice of position"
10777688|NCT04359797|BG001|Baseline|Prone|"Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.~Prone: Provider-recommended guidance on prone positioning of patients"
10777689|NCT04359797|BG002|Baseline|Total|Total of all reporting groups
10777690|NCT04359797|FG000|Participant Flow|Usual Care|"Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.~Usual Care: No provider-recommendation, patients will remain in their natural choice of position"
10777691|NCT04359797|FG001|Participant Flow|Prone|"Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.~Prone: Provider-recommended guidance on prone positioning of patients"
10777692|NCT04359797|OG000|Outcome|Usual Care|"Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.~Usual Care: No provider-recommendation, patients will remain in their natural choice of position"
10777693|NCT04359797|OG001|Outcome|Prone|"Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.~Prone: Provider-recommended guidance on prone positioning of patients"
10777694|NCT04359797|EG000|Reported Event|Usual Care|"Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.~Usual Care: No provider-recommendation, patients will remain in their natural choice of position"
10777695|NCT04359797|EG001|Reported Event|Prone|"Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.~Prone: Provider-recommended guidance on prone positioning of patients"
10777696|NCT04151290|BG000|Baseline|Cognoa Assessment|"Cognoa diagnostic ASD device.~Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)"
10777697|NCT04151290|FG000|Participant Flow|Cognoa Assessment|"Cognoa diagnostic ASD device.~Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)"
10777698|NCT04151290|OG000|Outcome|Cognoa Assessment|"Cognoa diagnostic ASD device.~Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)"
10777699|NCT04151290|EG000|Reported Event|Cognoa Assessment|"Cognoa diagnostic ASD device.~Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)"
10800989|NCT03067129|OG000|Outcome|Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs|Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
10800990|NCT03067129|OG001|Outcome|Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
10800991|NCT03067129|OG002|Outcome|Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
10800992|NCT03067129|OG003|Outcome|Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
10800993|NCT03067129|OG004|Outcome|Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
10800994|NCT03067129|OG005|Outcome|Participants in Cohorts 1, 2, 3, and 4|Participants who received at least 1 dose of study drug
10800995|NCT03067129|OG000|Outcome|Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
10800996|NCT03067129|OG001|Outcome|Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
10800997|NCT03067129|OG002|Outcome|Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
10800998|NCT03067129|OG003|Outcome|Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
11339690|NCT03635320|BG000|Baseline|TFNA Group (Study Group)|intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
11378904|NCT01175356|OG000|Outcome|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
10800999|NCT03067129|EG000|Reported Event|Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs|Adult formulation glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
11339691|NCT03635320|BG001|Baseline|PFNA-II Group (Control Group)|intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
11339692|NCT03635320|BG002|Baseline|Total|Total of all reporting groups
11339693|NCT03635320|FG000|Participant Flow|TFNA Group (Study Group)|intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
11339694|NCT03635320|FG001|Participant Flow|PFNA-II Group (Control Group)|intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
11339695|NCT03635320|OG000|Outcome|TFNA Group (Study Group)|intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
11339696|NCT03635320|OG001|Outcome|PFNA-II Group (Control Group)|intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
11339697|NCT03635320|EG000|Reported Event|TFNA Group (Study Group)|intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
11339698|NCT03635320|EG001|Reported Event|PFNA-II Group (Control Group)|intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
11339699|NCT03635775|BG000|Baseline|Anodal Ipsilesional Active tDCS|"Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339700|NCT03635775|BG001|Baseline|Cathodal Contralesional Active tDCS|"Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339701|NCT03635775|BG002|Baseline|Anodal Contralesional Active tDCS|"Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339702|NCT03635775|BG003|Baseline|Sham tDCS|"Sham tDCS applied in one of the above configurations~Sham tDCS: Sham-setting--no electrical current delivered."
11339703|NCT03635775|BG004|Baseline|Total|Total of all reporting groups
11339704|NCT03635775|FG000|Participant Flow|Anodal Ipsilesional Active tDCS|"Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339705|NCT03635775|FG001|Participant Flow|Cathodal Contralesional Active tDCS|"Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339706|NCT03635775|FG002|Participant Flow|Anodal Contralesional Active tDCS|"Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339707|NCT03635775|FG003|Participant Flow|Sham tDCS|"Sham tDCS applied in one of the above configurations~Sham tDCS: Sham-setting--no electrical current delivered."
11339708|NCT03635775|OG000|Outcome|Anodal Ipsilesional Active tDCS|"Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339709|NCT03635775|OG001|Outcome|Cathodal Contralesional Active tDCS|"Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339710|NCT03635775|OG002|Outcome|Anodal Contralesional Active tDCS|"Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339711|NCT03635775|OG003|Outcome|Sham tDCS|"Sham tDCS applied in one of the above configurations~Sham tDCS: Sham-setting--no electrical current delivered."
11339712|NCT03635775|EG000|Reported Event|Anodal Ipsilesional Active tDCS|"Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339713|NCT03635775|EG001|Reported Event|Cathodal Contralesional Active tDCS|"Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339714|NCT03635775|EG002|Reported Event|Anodal Contralesional Active tDCS|"Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.~Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges."
11339715|NCT03635775|EG003|Reported Event|Sham tDCS|"Sham tDCS applied in one of the above configurations~Sham tDCS: Sham-setting--no electrical current delivered."
11339716|NCT03635957|BG000|Baseline|Pegloticase With Methotrexate (MTX)|"Run-In Period: oral MTX at a dose of 15 mg weekly for 4 weeks prior to the first dose of pegloticase.~Pegloticase + IMM Period: pegloticase 8 mg administered IV every 2 weeks from Day 1 through the Week 50 Visit for a total of 26 infusions. MTX 15 mg weekly on the same day each week, within 1 to 3 days prior to each pegloticase infusion and one additional weekly dose after the last infusion."
11339717|NCT03635957|FG000|Participant Flow|All Participants|"Run-In Period: oral MTX at a dose of 15 mg weekly for 4 weeks prior to the first dose of pegloticase.~Pegloticase + Immunomodulator (IMM) Period: pegloticase 8 mg administered intravenously (IV) every 2 weeks from Day 1 through the Week 50 Visit for a total of 26 infusions. MTX 15 mg weekly on the same day each week, within 1 to 3 days prior to each pegloticase infusion and one additional weekly dose after the last infusion."
11378905|NCT01175356|EG000|Reported Event|Treatment (131I-MIBG, Chemotherapy)|Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
11378906|NCT00515853|BG000|Baseline|Biofeedback|"Received feedback~Biofeedback: Biofeedback sessions or biofeedback exercises"
11378907|NCT00515853|BG001|Baseline|No Biofeedback|Did not received feedback
11378908|NCT00515853|BG002|Baseline|Total|Total of all reporting groups
11378909|NCT00515853|FG000|Participant Flow|Biofeedback|"Received feedback~Biofeedback: Biofeedback sessions or biofeedback exercises"
11378910|NCT00515853|FG001|Participant Flow|No Biofeedback|Did not received feedback
11378911|NCT00515853|OG000|Outcome|Biofeedback|"Received feedback~Biofeedback: Biofeedback sessions or biofeedback exercises"
11378912|NCT00515853|OG001|Outcome|No Biofeedback|Did not received feedback
11378913|NCT00515853|EG000|Reported Event|Biofeedback|"Received feedback~Biofeedback: Biofeedback sessions or biofeedback exercises"
11378914|NCT00515853|EG001|Reported Event|No Biofeedback|Did not received feedback
11378915|NCT00003458|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11378916|NCT00003458|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11378917|NCT00003458|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11378918|NCT00003458|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11378919|NCT00003458|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10777700|NCT04038385|BG000|Baseline|Intervention|"This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period [June 19 to August 19]), and 2) monthly trips to an area farmers' market and local supermarket (between September 1, 2019 and November 30, 2019 [the end of the local growing season]).~Multilevel Behavioral Intervention: Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables."
10777701|NCT04038385|BG001|Baseline|Control|This group will receive routine services provided by WIC only.
10777702|NCT04038385|BG002|Baseline|Total|Total of all reporting groups
10777703|NCT04038385|FG000|Participant Flow|Intervention|"This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period [June 19 to August 19]), and 2) monthly trips to an area farmers' market and local supermarket (between September 1, 2019 and November 30, 2019 [the end of the local growing season]).~Multilevel Behavioral Intervention: Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables."
10777704|NCT04038385|FG001|Participant Flow|Control|This group will receive routine services provided by WIC only.
10777705|NCT04038385|OG000|Outcome|Intervention|"This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period [June 19 to August 19]), and 2) monthly trips to an area farmers' market and local supermarket (between September 1, 2019 and November 30, 2019 [the end of the local growing season]).~Multilevel Behavioral Intervention: Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables."
11240911|NCT02482675|EG002|Reported Event|Glucose With Whey Protein Isolate|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Whey Protein Isolate: Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes."
10777706|NCT04038385|OG001|Outcome|Control|This group will receive routine services provided by WIC only.
10777707|NCT04038385|EG000|Reported Event|Intervention|"This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period [June 19 to August 19]), and 2) monthly trips to an area farmers' market and local supermarket (between September 1, 2019 and November 30, 2019 [the end of the local growing season]).~Multilevel Behavioral Intervention: Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables."
10777708|NCT04038385|EG001|Reported Event|Control|This group will receive routine services provided by WIC only.
10777709|NCT03923738|BG000|Baseline|TCZ IV Q4W|Participants with GCA who received at least 5 consecutive doses of 8 mg/kg IV TCZ Q4W prior to baseline and reached remission received 5 or 6 consecutive doses of 7 mg/kg IV TCZ Q4W in Period 1. Participants that completed Period 1 and were in remission received 5 or 6 consecutive doses of 6 mg/kg IV TCZ Q4W in Period 2.
10777710|NCT03923738|FG000|Participant Flow|TCZ IV Q4W|Participants with GCA who received at least 5 consecutive doses of 8 mg/kg IV TCZ Q4W prior to baseline and reached remission received 5 or 6 consecutive doses of 7 mg/kg IV TCZ Q4W in Period 1. Participants that completed Period 1 and were in remission received 5 or 6 consecutive doses of 6 mg/kg IV TCZ Q4W in Period 2.
10777711|NCT03923738|OG000|Outcome|TCZ IV Q4W 7 mg/kg|Participants with GCA who received at least 5 consecutive doses of 8 mg/kg TCZ prior to baseline and reached remission received 5 or 6 consecutive doses of 7 mg/kg IV TCZ Q4W (Period 1).
10777712|NCT03923738|OG001|Outcome|TCZ IV Q4W 6 mg/kg|Participants that completed Period 1 and were in remission received 5 or 6 consecutive doses of 6 mg/kg IV TCZ Q4W (Period 2).
10777713|NCT03923738|EG000|Reported Event|TCZ IV 7 mg/kg Q4W|Participants with GCA who received at least 5 consecutive doses of 8 mg/kg TCZ prior to baseline and reached remission received 5 or 6 consecutive doses of 7 mg/kg IV TCZ Q4W (Period 1).
10777714|NCT03923738|EG001|Reported Event|TCZ IV 6 mg/kg Q4W|Participants that completed Period 1 and were in remission received 5 or 6 consecutive doses of 6 mg/kg IV TCZ Q4W (Period 2).
10777715|NCT03887117|BG000|Baseline|IQOS-1|"IQOS + Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.~IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program"
10777716|NCT03887117|BG001|Baseline|IQOS-2|"No Training~Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.~No Training: Switch to IQOS use only, without participation in a training program"
10777717|NCT03887117|BG002|Baseline|Cigarette Smoking|"Cigarette Smoking + Exercise Training Program~Subjects randomized to continued cigarette smoking and participation in an exercise training program.~Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program"
10777718|NCT03887117|BG003|Baseline|Smoking Abstinence|"Smoking Abstinence + Exercise Training Program~Subjects randomized to smoking abstinence and participation in an exercise training program.~Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program"
10777719|NCT03887117|BG004|Baseline|Total|Total of all reporting groups
11378932|NCT04772560|BG000|Baseline|All Participants|23 participants who had completed the study
11378933|NCT04772560|FG000|Participant Flow|Toric Then Spherical|Participants who received toric contact lenses first and spherical lenses after 10 days
11378920|NCT04871815|BG000|Baseline|Treatment of COVID19 Long Haulers With Sodium Pyruvate Nasal Spray|This is a single arm, two phased, open label study. All subjects will be provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale for one week with no treatment. Vital signs (Blood pressure, temperature, Pulse and SaO2) will be recorded on day 1 and 7. After recording baseline symptoms for one week without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) will be recorded on day 7 after the first treatment and on day 14.
11378921|NCT04871815|FG000|Participant Flow|No Treatment First Then Sodium Pyruvate Nasal Spray|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (1-10 with 10 being the most severe) for one week with no treatment. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 7 and body temperature recorded twice daily from day 1 to day 7. After recording baseline signs and symptoms for one week without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (day 7-14) and continue to log their symptoms. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 7 after the first treatment and on day 14. Body temperature continued to be recorded twice daily from day 7 to day 14.
11378922|NCT04871815|OG000|Outcome|Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray|After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14.
11378923|NCT04871815|OG001|Outcome|Long COVID-19, No Treatment (Baseline)|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
11378924|NCT04871815|OG000|Outcome|COVID19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray|After recording baseline signs and symptoms for one week without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 8 after the first treatment and on day 14. Body temperature continued to be recorded twice daily from day 8 to day 14.
11378925|NCT04871815|OG001|Outcome|COVID-19 Long Haulers, No Treatment (Baseline)|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 8 and body temperature recorded twice daily from day 1 to day 7.
11378926|NCT04871815|OG000|Outcome|COVID19 Long Haulers, Treatment With 20mM Sodium Pyruvate Nasal Spray|After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects will then use N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continue to log their symptoms. Vital signs (Blood pressure, Pulse and SaO2) were recorded on day 8 after the first treatment and on day 14. Body temperature was recorded twice daily from day 8-14.
11378927|NCT04871815|OG001|Outcome|COVID19 Long Haulers, No Treatment (Baseline)|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and day 8 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
11378928|NCT04871815|OG000|Outcome|COVID-19 Long Haulers, Treatment With Sodium Pyruvate Nasal Spray|After recording baseline signs and symptoms for one week without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 7 after the first treatment and on day 14. Body temperature continued to be recorded twice daily from day 8 to day 14.
11378929|NCT04871815|OG001|Outcome|COVID-19 Long Haulers, No Treatment (Baseline)|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (1-10 with 10 being the most severe) for one week with no treatment. Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 7 and body temperature recorded twice daily from day 1 to day 7.
11378930|NCT04871815|EG000|Reported Event|Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray|After recording baseline symptoms for one week (days 1-7) without any treatment, all subjects then used N115 20mM sodium pyruvate nasal spray 3x daily for an additional week (days 8-14) and continued to log their symptoms. Vital signs (Blood pressure, temperature, Pulse and SaO2) were recorded on day 7 after the first treatment and on day 14.
11378931|NCT04871815|EG001|Reported Event|Long COVID-19, No Treatment (Baseline)|All subjects were provided a log for monitoring baseline symptoms associated with Long COVID and asked to record symptom severity using a Likert scale (0-10 with 10 being the most severe) for one week with no treatment (day 1-7). Vital signs (Blood pressure, Pulse, and SaO2) were recorded on day 1 and 7 prior to treatment and body temperature recorded twice daily from day 1 to day 7.
11378934|NCT04772560|FG001|Participant Flow|Spherical Then Toric|Participants who received spherical contact lenses first and toric lenses after 10 days
11378935|NCT04772560|OG000|Outcome|All Participants|23 participants who had completed the study
11378936|NCT04772560|EG000|Reported Event|Toric Contact Lens Wear|23 participants had completed the study
11378937|NCT04772560|EG001|Reported Event|Spherical Contact Lens Wear|23 participants had completed the study
10777720|NCT03887117|FG000|Participant Flow|IQOS-1|"IQOS + Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.~IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program"
10777721|NCT03887117|FG001|Participant Flow|IQOS-2|"IQOS without Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program."
10777722|NCT03887117|FG002|Participant Flow|Cigarette Smoking|"Cigarette Smoking + Exercise Training Program~Subjects randomized to continued cigarette smoking and participation in an exercise training program.~Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program"
10777723|NCT03887117|FG003|Participant Flow|Smoking Abstinence|"Smoking Abstinence + Exercise Training Program~Subjects randomized to smoking abstinence and participation in an exercise training program.~Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program"
10777724|NCT03887117|OG000|Outcome|Cigarette Smoking|"Cigarette Smoking + Exercise Training Program~Subjects randomized to continued cigarette smoking and participation in an exercise training program."
10777725|NCT03887117|OG001|Outcome|IQOS-1|"IQOS + Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program."
10777726|NCT03887117|OG002|Outcome|IQOS-2|"IQOS without Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program."
10777727|NCT03887117|OG003|Outcome|Smoking Abstinence|"Smoking Abstinence + Exercise Training Program~Subjects randomized to smoking abstinence and participation in an exercise training program."
10777728|NCT03887117|OG004|Outcome|Dual-1|Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
10777729|NCT03887117|OG005|Outcome|Dual-2|Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
10777730|NCT03887117|OG006|Outcome|Other|Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
10966592|NCT00887640|OG000|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
10777731|NCT03887117|OG005|Outcome|Dual-2|Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month
10777732|NCT03887117|OG002|Outcome|Smoking Abstinence|"Smoking Abstinence + Exercise Training Program~Subjects randomized to smoking abstinence and participation in an exercise training program."
10777733|NCT03887117|OG003|Outcome|Other|Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
10777734|NCT03887117|OG004|Outcome|Other|Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
10777735|NCT03887117|OG002|Outcome|IQOS-2|IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
10777736|NCT03887117|EG000|Reported Event|Cigarette Smoking|"Cigarette Smoking + Exercise Training Program~Subjects randomized to continued cigarette smoking and participation in an exercise training program.~Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program"
10777737|NCT03887117|EG001|Reported Event|IQOS-1|"IQOS + Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.~IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program"
10777738|NCT03887117|EG002|Reported Event|IQOS-2|"IQOS without Exercise Training Program~Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program."
10777739|NCT03887117|EG003|Reported Event|Smoking Abstinence|"Smoking Abstinence + Exercise Training Program~Subjects randomized to smoking abstinence and participation in an exercise training program.~Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program"
10777740|NCT03887117|EG004|Reported Event|Other|Other product use (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)
10777741|NCT03858634|BG000|Baseline|KPL-716|KPL-716 weekly for 8 weeks
10777742|NCT03858634|BG001|Baseline|Placebo|Placebo weekly for 8 weeks
10777743|NCT03858634|BG002|Baseline|Total|Total of all reporting groups
10777744|NCT03858634|FG000|Participant Flow|KPL-716|KPL-716 weekly for 8 weeks
10777745|NCT03858634|FG001|Participant Flow|Placebo|Placebo weekly for 8 weeks
10777746|NCT03858634|OG000|Outcome|KPL-716: CIU Cohort|Participants with CIU received KPL-716 weekly for 8 weeks
10777747|NCT03858634|OG001|Outcome|Placebo: CIU Cohort|Participants with CIU received placebo weekly for 8 weeks
10777748|NCT03858634|OG002|Outcome|KPL-716: CIP Cohort|Participants with CIP received KPL-716 weekly for 8 weeks
10777749|NCT03858634|OG003|Outcome|Placebo: CIP Cohort|Participants with CIP received placebo weekly for 8 weeks
10777750|NCT03858634|OG004|Outcome|KPL-716: LP Cohort|Participants with LP received KPL-716 weekly for 8 weeks
10777751|NCT03858634|OG005|Outcome|Placebo: LP Cohort|Participants with LP received placebo weekly for 8 weeks
10777752|NCT03858634|OG006|Outcome|KPL-716: LSC Cohort|Participants with LSC received KPL-716 weekly for 8 weeks
10777753|NCT03858634|OG007|Outcome|Placebo: LSC Cohort|Participants with LSC received placebo weekly for 8 weeks
10777754|NCT03858634|OG008|Outcome|KPL-716: PPs Cohort|Participants with PPs received KPL-716 weekly for 8 weeks
10777755|NCT03858634|OG009|Outcome|Placebo: PPs Cohort|Participants with PPs received placebo weekly for 8 weeks
10777756|NCT03858634|EG000|Reported Event|KPL-716|KPL-716 weekly for 8 weeks
10777757|NCT03858634|EG001|Reported Event|Placebo|Placebo weekly for 8 weeks
10777758|NCT03819114|BG000|Baseline|A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777759|NCT03819114|BG001|Baseline|B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
11378938|NCT04613739|BG000|Baseline|Insurance Navigation|"The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.~insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed."
11378939|NCT04613739|BG001|Baseline|Wait-list Controls|Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
11378940|NCT04613739|BG002|Baseline|Total|Total of all reporting groups
11378941|NCT04613739|FG000|Participant Flow|Insurance Navigation|"The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.~insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed."
11378942|NCT04613739|FG001|Participant Flow|Wait-list Controls|Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
11378943|NCT04613739|OG000|Outcome|Insurance Navigation|"The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.~insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed."
11378944|NCT04613739|OG001|Outcome|Wait-list Controls|Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
11378945|NCT04613739|EG000|Reported Event|Insurance Navigation|"The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.~insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed."
11378946|NCT04613739|EG001|Reported Event|Wait-list Controls|Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
11378956|NCT04432272|BG000|Baseline|Group A|"Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
10777760|NCT03819114|BG002|Baseline|C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777761|NCT03819114|BG003|Baseline|D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777762|NCT03819114|BG004|Baseline|Total|Total of all reporting groups
10777763|NCT03819114|FG000|Participant Flow|A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777764|NCT03819114|FG001|Participant Flow|B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777765|NCT03819114|FG002|Participant Flow|C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777766|NCT03819114|FG003|Participant Flow|D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777767|NCT03819114|OG000|Outcome|A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777768|NCT03819114|OG001|Outcome|B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777769|NCT03819114|OG002|Outcome|C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777770|NCT03819114|OG003|Outcome|D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777771|NCT03819114|OG000|Outcome|LNG 1.5 mg|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777772|NCT03819114|OG001|Outcome|LNG 3.0 mg|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777773|NCT03819114|EG000|Reported Event|A: LNG 1.5 mg Among Women on EFV-based ART (Randomized)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777774|NCT03819114|EG001|Reported Event|B: LNG 3.0 mg Among Women on EFV-based ART (Randomized)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777775|NCT03819114|EG002|Reported Event|C: LNG 1.5 mg Among Women on DTG-based ART (Assigned)|Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777776|NCT03819114|EG003|Reported Event|D: LNG 3.0 mg Among Women on RIF-INH TB Therapy (Assigned)|Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
10777777|NCT03804268|BG000|Baseline|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10777778|NCT03804268|BG001|Baseline|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10777779|NCT03804268|BG002|Baseline|Total|Total of all reporting groups
10777780|NCT03804268|FG000|Participant Flow|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10777781|NCT03804268|FG001|Participant Flow|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine hydrochloride (HCl) ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10777782|NCT03804268|OG000|Outcome|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10777783|NCT03804268|OG001|Outcome|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10777784|NCT03804268|OG001|Outcome|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution1.25% in each eye, once daily, for up to 30 days.
10777785|NCT03804268|EG000|Reported Event|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10777786|NCT03804268|EG001|Reported Event|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10801000|NCT03067129|EG001|Reported Event|Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
10801001|NCT03067129|EG002|Reported Event|Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
10801002|NCT03067129|EG003|Reported Event|Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
10801003|NCT03067129|EG004|Reported Event|Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs|Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
10801004|NCT03067129|EG005|Reported Event|Participants in Cohorts 1, 2, 3, and 4|Participants who received at least 1 dose of study drug
10801005|NCT03053102|BG000|Baseline|Danicopan|Participants received danicopan 100 to 200 mg TID.
10801006|NCT03053102|FG000|Participant Flow|Danicopan|Participants received danicopan 100 to 200 mg TID.
10801007|NCT03053102|OG000|Outcome|Danicopan|Participants received danicopan 100 to 200 mg TID.
10801008|NCT03053102|OG000|Outcome|Danicopan|Participants who received danicopan 100 to 200 mg TID.
10777787|NCT04435808|BG000|Baseline|Hydroxychloroquine Arm|"Group A: 0 health care workers who choose to take hydroxychloroquine~Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.~Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily"
10777788|NCT04435808|BG001|Baseline|No Intervention Arm|Group B: 1 health care workers who chose not to take hydroxychloroquine
10777789|NCT04435808|BG002|Baseline|Total|Total of all reporting groups
10777790|NCT04435808|FG000|Participant Flow|Hydroxychloroquine Arm|"Group A: 0 health care workers who chose to take hydroxychloroquine~Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.~Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily"
10777791|NCT04435808|FG001|Participant Flow|No Intervention Arm|Group B: 1 health care worker who chose not to take hydroxychloroquine
10777792|NCT04435808|OG000|Outcome|Hydroxychloroquine Arm|"Group A: 0 health care workers who chose to take hydroxychloroquine~Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.~Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily"
10777793|NCT04435808|OG001|Outcome|No Intervention Arm|Group B: 1 health care worker who chose not to take hydroxychloroquine
10777794|NCT04435808|EG000|Reported Event|Hydroxychloroquine Arm|"Group A: 0 health care workers who chose to take hydroxychloroquine~Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.~Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily"
10777795|NCT04435808|EG001|Reported Event|No Intervention Arm|Group B: 0 health care worker who chose not to take hydroxychloroquine
10777796|NCT04409262|BG000|Baseline|Remdesivir + Placebo (RDV+PBO)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777797|NCT04409262|BG001|Baseline|Remdesivir + Tocilizumab (RDV+TCZ)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777798|NCT04409262|BG002|Baseline|Total|Total of all reporting groups
10777799|NCT04409262|FG000|Participant Flow|Remdesivir + Placebo (RDV+PBO)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777800|NCT04409262|FG001|Participant Flow|Remdesivir + Tocilizumab (RDV+TCZ)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777801|NCT04409262|OG000|Outcome|Remdesivir + Placebo (RDV+Placebo) - mITT Population|The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
10777802|NCT04409262|OG001|Outcome|Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population|The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
10777803|NCT04409262|OG000|Outcome|Remdesivir + Placebo (RDV+PBO) - mITT Population|The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.
10777804|NCT04409262|OG000|Outcome|Remdesivir + Placebo (RDV+PBO) - Safety Population|The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.
10777805|NCT04409262|OG001|Outcome|Remdesivir + Tocilizumab (RDV+TCZ) - Safety Population|The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.
10777806|NCT04409262|EG000|Reported Event|Remdesivir + Placebo (RDV+PBO)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777807|NCT04409262|EG001|Reported Event|Remdesivir + Tocilizumab (RDV+TCZ)|Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.
10777808|NCT04305912|BG000|Baseline|Overall Study|Subjects will be randomized to wear somofilcon A daily disposable lenses and verofilcon A daily disposable lenses for one week.
10777809|NCT04305912|FG000|Participant Flow|Somofilcon A Then Verofilcon A|Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.
10801009|NCT03053102|EG000|Reported Event|Danicopan|Participants received danicopan 100 to 200 mg TID.
10777810|NCT04305912|FG001|Participant Flow|Verofilcon A the Somofilcon A|Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
10777811|NCT04305912|OG000|Outcome|Somofilcon A|Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
10777812|NCT04305912|OG001|Outcome|Verofilcon A|Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
10777813|NCT04305912|EG000|Reported Event|Somofilcon A|Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.
10777814|NCT04305912|EG001|Reported Event|Verofilcon A|Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
10801010|NCT02964078|BG000|Baseline|Pembrolizumab and Interleukin-2|Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
10801011|NCT02964078|FG000|Participant Flow|Pembrolizumab and Interleukin-2|Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
10801012|NCT02964078|OG000|Outcome|Pembrolizumab and Interleukin-2|Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
10801013|NCT02964078|EG000|Reported Event|Pembrolizumab and Interleukin-2|Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
10801014|NCT02937818|BG000|Baseline|Arm A: Durvalumab + Tremelimumab (Original Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
10801015|NCT02937818|BG001|Baseline|Arm A: Durvalumab + Tremelimumab (Expansion Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
10801016|NCT02937818|BG002|Baseline|Arm B: Adavosertib + Carboplatin|Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
10801017|NCT02937818|BG003|Baseline|Arm C: Ceralasertib (AZD6738) + Olaparib|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801018|NCT02937818|BG004|Baseline|Total|Total of all reporting groups
10801019|NCT02937818|FG000|Participant Flow|Arm A: Durvalumab + Tremelimumab (Original Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
10801020|NCT02937818|FG001|Participant Flow|Arm A: Durvalumab + Tremelimumab (Expansion Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
10801021|NCT02937818|FG002|Participant Flow|Arm B: Adavosertib + Carboplatin|Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
10801022|NCT02937818|FG003|Participant Flow|Arm C: Ceralasertib (AZD6738) + Olaparib|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801023|NCT02937818|OG000|Outcome|Arm A: Durvalumab + Tremelimumab (Original Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
10801024|NCT02937818|OG001|Outcome|Arm A: Durvalumab + Tremelimumab (Expansion Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
10801025|NCT02937818|OG002|Outcome|Arm B: Adavosertib + Carboplatin|Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
10801026|NCT02937818|OG003|Outcome|Arm C: Ceralasertib (AZD6738) + Olaparib|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801027|NCT02937818|OG000|Outcome|Ceralasertib (AZD6738)|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801028|NCT02937818|OG001|Outcome|Olaparib|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801029|NCT02937818|OG000|Outcome|Arm B: Adavosertib + Carboplatin|Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
10801030|NCT02937818|EG000|Reported Event|Arm A: Durvalumab + Tremelimumab (Original Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
10801031|NCT02937818|EG001|Reported Event|Arm A: Durvalumab + Tremelimumab (Expansion Cohort)|Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
10801032|NCT02937818|EG002|Reported Event|Arm B: Adavosertib + Carboplatin|Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
11193243|NCT02143947|EG001|Reported Event|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
11378947|NCT04573972|BG000|Baseline|Regular Incentive|"During the two-week intervention period, the standard incentive group will earn $2 per day when they meet their step goal, and this reward is earned regardless of whether they walk alone or with others.~Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together"
11378948|NCT04573972|BG001|Baseline|Social Incentive|"During the two-week intervention period, he social incentive group will earn $1 per day when they meet their step goal and an additional $1 if they walk 2,000 steps together with another study participant.~Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together"
11378949|NCT04573972|BG002|Baseline|Total|Total of all reporting groups
11378950|NCT04573972|FG000|Participant Flow|Regular Incentive|"During the two-week intervention period, the standard incentive group will earn $2 per day when they meet their step goal, and this reward is earned regardless of whether they walk alone or with others.~Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together"
11378951|NCT04573972|FG001|Participant Flow|Social Incentive|"During the two-week intervention period, he social incentive group will earn $1 per day when they meet their step goal and an additional $1 if they walk 2,000 steps together with another study participant.~Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together"
11378952|NCT04573972|OG000|Outcome|Regular Incentive|"During the two-week intervention period, the standard incentive group will earn $2 per day when they meet their step goal, and this reward is earned regardless of whether they walk alone or with others.~Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together"
11378953|NCT04573972|OG001|Outcome|Social Incentive|"During the two-week intervention period, he social incentive group will earn $1 per day when they meet their step goal and an additional $1 if they walk 2,000 steps together with another study participant.~Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together"
11378954|NCT04573972|EG000|Reported Event|Regular Incentive|"During the two-week intervention period, the standard incentive group will earn $2 per day when they meet their step goal, and this reward is earned regardless of whether they walk alone or with others.~Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together"
11378955|NCT04573972|EG001|Reported Event|Social Incentive|"During the two-week intervention period, he social incentive group will earn $1 per day when they meet their step goal and an additional $1 if they walk 2,000 steps together with another study participant.~Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together"
11378957|NCT04432272|BG001|Baseline|Group B|"Hospitalized COVID-19 patients ages ≥18 years requiring intubation.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378958|NCT04432272|BG002|Baseline|Total|Total of all reporting groups
11378959|NCT04432272|FG000|Participant Flow|Group A|"Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378960|NCT04432272|FG001|Participant Flow|Group B|"Hospitalized COVID-19 patients ages ≥18 years requiring intubation.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378961|NCT04432272|OG000|Outcome|Group A|"Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
10777815|NCT04030416|BG000|Baseline|Healthy Blood Donors|single arm study with healthy blood donors
10777816|NCT04030416|FG000|Participant Flow|Healthy Blood Donors|single arm study with healthy blood donors
10777817|NCT04030416|OG000|Outcome|Healthy Blood Donors|single arm study with healthy blood donors
10777818|NCT04030416|EG000|Reported Event|Single Arm Study|healthy blood donors
11378962|NCT04432272|OG000|Outcome|Group B|"Hospitalized COVID-19 patients ages ≥18 years requiring intubation.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378963|NCT04432272|OG001|Outcome|Group B|"Hospitalized COVID-19 patients ages ≥18 years requiring intubation.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378964|NCT04432272|EG000|Reported Event|Group A|"Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378965|NCT04432272|EG001|Reported Event|Group B|"Hospitalized COVID-19 patients ages ≥18 years requiring intubation.~COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit"
11378966|NCT04407806|BG000|Baseline|Continuous Pulse Oximetry Monitoring of Oxygen Saturation|"Continuous pulse oximetry to measure oxygen saturation~Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization"
11378967|NCT04407806|BG001|Baseline|Intermittent Pulse Oximetry Monitoring of Oxygen Saturation|"Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours~Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization"
11378968|NCT04407806|BG002|Baseline|Total|Total of all reporting groups
11378969|NCT04407806|FG000|Participant Flow|Continuous Pulse Oximetry Monitoring of Oxygen Saturation|"Continuous pulse oximetry to measure oxygen saturation~Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization"
11378970|NCT04407806|FG001|Participant Flow|Intermittent Pulse Oximetry Monitoring of Oxygen Saturation|"Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours~Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization"
11378971|NCT04407806|OG000|Outcome|Continuous Pulse Oximetry Monitoring of Oxygen Saturation|"Continuous pulse oximetry to measure oxygen saturation~Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization"
11378972|NCT04407806|OG001|Outcome|Intermittent Pulse Oximetry Monitoring of Oxygen Saturation|"Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours~Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization"
11378973|NCT04407806|EG000|Reported Event|Continuous Pulse Oximetry Monitoring of Oxygen Saturation|"Continuous pulse oximetry to measure oxygen saturation~Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization"
11378974|NCT04407806|EG001|Reported Event|Intermittent Pulse Oximetry Monitoring of Oxygen Saturation|"Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours~Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization"
11378975|NCT04324021|BG000|Baseline|Emapalumab|"Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg~Emapalumab: I.v. infusion every third day"
11378976|NCT04324021|BG001|Baseline|Anakinra|"Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours~Anakinra: Daily i.v. infusion"
11378977|NCT04324021|BG002|Baseline|Standard of Care|Standard of care according to local practice
11378978|NCT04324021|BG003|Baseline|Total|Total of all reporting groups
11378979|NCT04324021|FG000|Participant Flow|Emapalumab|"Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg~Emapalumab: I.v. infusion every third day"
11378980|NCT04324021|FG001|Participant Flow|Anakinra|"Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours~Anakinra: Daily i.v. infusion"
10777819|NCT04028648|BG000|Baseline|Elderly|150 elderlies (>60 years): community dwelling or living in old
10777820|NCT04028648|FG000|Participant Flow|Elderly|150 elderlies (>60 years): community dwelling or living in old people's homes.
10777821|NCT04028648|OG000|Outcome|Elderly|150 elderlies (>60 years): community dwelling or living in old
10777822|NCT04028648|OG000|Outcome|Elderly|150 elderlies (>60 years): community dwelling or living in old people's homes.
10777823|NCT04028648|EG000|Reported Event|Elderly|150 elderlies (>60 years): community dwelling or living in old
10777824|NCT03987919|BG000|Baseline|5 mg Tirzepatide|5 mg tirzepatide administered SC once a week.
10777825|NCT03987919|BG001|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777826|NCT03987919|BG002|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777827|NCT03987919|BG003|Baseline|1 mg Semaglutide|1 mg semaglutide administered SC once a week.
10777828|NCT03987919|BG004|Baseline|Total|Total of all reporting groups
10777829|NCT03987919|FG000|Participant Flow|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10777830|NCT03987919|FG001|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777831|NCT03987919|FG002|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777832|NCT03987919|FG003|Participant Flow|1 mg Semaglutide|1 mg semaglutide administered SC once a week.
10777833|NCT03987919|OG000|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777834|NCT03987919|OG001|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777835|NCT03987919|OG002|Outcome|1 mg Semaglutide|1 mg semaglutide administered SC once a week.
10777836|NCT03987919|OG000|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered SC once a week.
11193244|NCT02143973|BG000|Baseline|Nalbuphine HCl ER|nalbuphine HCl ER
10777837|NCT03987919|OG001|Outcome|1 mg Semaglutide|1 mg semaglutide administered SC once a week.
10777838|NCT03987919|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777839|NCT03987919|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777840|NCT03987919|OG003|Outcome|1 mg Semaglutide|1 mg of semaglutide administered SC once a week.
10777841|NCT03987919|OG003|Outcome|1 mg Semaglutide|1 mg semaglutide administered SC once a week.
10777842|NCT03987919|EG000|Reported Event|5 mg Tirzepatide|5 mg tirzepatide administered subcutaneously (SC) once a week.
10777843|NCT03987919|EG001|Reported Event|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777844|NCT03987919|EG002|Reported Event|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777845|NCT03987919|EG003|Reported Event|1 mg Semaglutide|1 mg of semaglutide administered SC once a week.
10777846|NCT03980145|BG000|Baseline|Conventional Physical Therapy|"Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.~Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided."
10777847|NCT03980145|BG001|Baseline|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
10777848|NCT03980145|BG002|Baseline|Total|Total of all reporting groups
10777849|NCT03980145|FG000|Participant Flow|Conventional Physical Therapy|"Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.~Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided."
10801033|NCT02937818|EG003|Reported Event|Arm C: Ceralasertib (AZD6738) + Olaparib|Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
10801034|NCT02920476|BG000|Baseline|Treatment Arm|"TAS-102~TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.~Days 6 through 7: Rest~Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.~Days 13 through 28: Rest"
10801035|NCT02920476|FG000|Participant Flow|Treatment Arm|"TAS-102~TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.~Days 6 through 7: Rest~Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.~Days 13 through 28: Rest"
10850898|NCT03999554|BG001|Baseline|Medium Dose Sing2016 M2SR|"Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29~MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11378981|NCT04324021|FG002|Participant Flow|Standard of Care|Standard of care according to local practice
11378982|NCT04324021|OG000|Outcome|Emapalumab|"Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg~Emapalumab: I.v. infusion every third day"
11378983|NCT04324021|OG001|Outcome|Anakinra|"Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours~Anakinra: Daily i.v. infusion"
11378984|NCT04324021|OG002|Outcome|Standard of Care|Standard of care according to local practice
11378985|NCT04324021|OG000|Outcome|Emapalumab|"Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg~Emapalumab: I.v. infusion every third day~Abnormal CS at screening"
11378986|NCT04324021|OG001|Outcome|Anakinra|"Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours~Anakinra: Daily i.v. infusion~Abnormal CS at screening"
11378987|NCT04324021|OG002|Outcome|Standard of Care|"Standard of care according to local practice~Abnormal CS at screening"
11378988|NCT04324021|EG000|Reported Event|Emapalumab|"Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg~Emapalumab: I.v. infusion every third day"
11378989|NCT04324021|EG001|Reported Event|Anakinra|"Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours~Anakinra: Daily i.v. infusion"
11378990|NCT04324021|EG002|Reported Event|Standard of Care|Standard of care according to local practice
10801036|NCT02920476|OG000|Outcome|Treatment Arm|"TAS-102~TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.~Days 6 through 7: Rest~Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.~Days 13 through 28: Rest"
10777850|NCT03980145|FG001|Participant Flow|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has a unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
10777851|NCT03980145|OG000|Outcome|Conventional Physical Therapy|"Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.~Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided."
11193245|NCT02143973|FG000|Participant Flow|Nalbuphine HCl ER|"nalbuphine HCl ER~nalbuphine HCl ER BID: nalbuphine HCl ER titrated from 30 mg QD to 120 mg BID over three weeks based on tolerability and efficacy, then maintain dosing at that maximum achieved level; full titration and maintenance is 24 weeks."
11193246|NCT02143973|OG000|Outcome|Nalbuphine HCl ER|nalbuphine HCl ER
11193247|NCT02143973|EG000|Reported Event|Nalbuphine HCl ER|nalbuphine HCl ER
11193248|NCT02144012|BG000|Baseline|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
10777852|NCT03980145|OG001|Outcome|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
11193249|NCT02144012|BG001|Baseline|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
11193250|NCT02144012|BG002|Baseline|Total|Total of all reporting groups
11193251|NCT02144012|FG000|Participant Flow|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
11193252|NCT02144012|FG001|Participant Flow|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
11193253|NCT02144012|OG000|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
11193254|NCT02144012|OG001|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
10777853|NCT03980145|OG001|Outcome|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes.~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
10777854|NCT03980145|OG001|Outcome|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes.~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
10777855|NCT03980145|EG000|Reported Event|Conventional Physical Therapy|"Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.~Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided."
10777856|NCT03980145|EG001|Reported Event|End-Effector Robotic Training|"G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute).~G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback."
10777857|NCT03861039|BG000|Baseline|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777858|NCT03861039|BG001|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777859|NCT03861039|BG002|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777860|NCT03861039|BG003|Baseline|Total|Total of all reporting groups
10777861|NCT03861039|FG000|Participant Flow|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777862|NCT03861039|FG001|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777863|NCT03861039|FG002|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777864|NCT03861039|OG000|Outcome|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10850899|NCT03999554|BG002|Baseline|High Dose Sing2016 M2SR|"High dose Sing2016 M2SR will be administered intranasally on days 1 and 29~HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10777865|NCT03861039|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777866|NCT03861039|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777867|NCT03861039|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777868|NCT03861039|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777869|NCT03861039|EG000|Reported Event|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777870|NCT03861039|EG001|Reported Event|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777871|NCT03861039|EG002|Reported Event|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10777872|NCT03759587|BG000|Baseline|Niraparib 300 mg|Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).
10777873|NCT03759587|FG000|Participant Flow|Niraparib 300 mg|Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).
10777874|NCT03759587|OG000|Outcome|Niraparib 300 mg|Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).
10777875|NCT03759587|EG000|Reported Event|Niraparib 300 mg|Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).
10777876|NCT03730662|BG000|Baseline|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10777877|NCT03730662|BG001|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777878|NCT03730662|BG002|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777879|NCT03730662|BG003|Baseline|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777880|NCT03730662|BG004|Baseline|Total|Total of all reporting groups
10777881|NCT03730662|FG000|Participant Flow|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10777882|NCT03730662|FG001|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777883|NCT03730662|FG002|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777884|NCT03730662|FG003|Participant Flow|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777885|NCT03730662|OG000|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777886|NCT03730662|OG001|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777887|NCT03730662|OG002|Outcome|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777888|NCT03730662|OG000|Outcome|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10777889|NCT03730662|OG001|Outcome|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777890|NCT03730662|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777891|NCT03730662|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777892|NCT03730662|OG003|Outcome|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777893|NCT03730662|EG000|Reported Event|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10777894|NCT03730662|EG001|Reported Event|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10777895|NCT03730662|EG002|Reported Event|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10777896|NCT03730662|EG003|Reported Event|Insulin Glargine|"Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm."
10777897|NCT03538444|BG000|Baseline|Active rTMS|"Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method~Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder"
10777898|NCT03538444|BG001|Baseline|Sham rTMS|"Participants will receive 18 sessions of sham rTMS over a period of three days.~Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive."
10777899|NCT03538444|BG002|Baseline|Total|Total of all reporting groups
10777900|NCT03538444|FG000|Participant Flow|Active rTMS|"Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method~Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder"
10777901|NCT03538444|FG001|Participant Flow|Sham rTMS|"Participants will receive 18 sessions of sham rTMS over a period of three days.~Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive."
10777902|NCT03538444|OG000|Outcome|Active rTMS|"Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method~Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder"
10777903|NCT03538444|OG001|Outcome|Sham rTMS|"Participants will receive 18 sessions of sham rTMS over a period of three days.~Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive."
10777904|NCT03538444|EG000|Reported Event|Active rTMS|"Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method~Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder"
10777905|NCT03538444|EG001|Reported Event|Sham rTMS|"Participants will receive 18 sessions of sham rTMS over a period of three days.~Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive."
10777906|NCT03410693|BG000|Baseline|Rogaratinib (BAY1163877)_Overall Population|Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
11240912|NCT02482675|EG003|Reported Event|Glucose With Sodium Caseinate|"This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.~Glucose with Sodium Caseinate: Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes."
10777907|NCT03410693|BG001|Baseline|Chemotherapy_Overall Population|Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
10777908|NCT03410693|BG002|Baseline|Total|Total of all reporting groups
10777909|NCT03410693|FG000|Participant Flow|Rogaratinib (BAY1163877)_Overall Population|Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
10777910|NCT03410693|FG001|Participant Flow|Chemotherapy_Overall Population|Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
10777911|NCT03410693|OG000|Outcome|Rogaratinib (BAY1163877)_Overall Population|Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
10777912|NCT03410693|OG001|Outcome|Chemotherapy_Overall Population|Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
10777913|NCT03410693|OG002|Outcome|Rogaratinib_WT Population|Rogaratinib arm, wild type population
10777914|NCT03410693|OG003|Outcome|Chemotherapy_WT Population|Chemotherapy group, wild type population
10777915|NCT03410693|OG002|Outcome|Rogaratinib_WT Population|Rogaratinib arm, Wild type population
10777916|NCT03410693|OG003|Outcome|Chemotherapy_WT Population|Chemotherapy group, Wild type population
10777917|NCT03410693|OG000|Outcome|Rogaratinib (BAY1163877)|Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
10777918|NCT03410693|OG001|Outcome|Chemotherapy|Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
10777919|NCT03410693|EG000|Reported Event|Rogaratinib (BAY1163877)|Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
10777920|NCT03410693|EG001|Reported Event|Chemotherapy|Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
10777921|NCT03359356|BG000|Baseline|Placebo Then Dupilumab|Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
10777922|NCT03359356|BG001|Baseline|Dupilumab|An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
10777923|NCT03359356|BG002|Baseline|Total|Total of all reporting groups
10777924|NCT03359356|FG000|Participant Flow|Placebo Then Dupilumab|"Placebo given Weeks 0-24, then Dupilumab given Weeks 24-48~Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses."
10777925|NCT03359356|FG001|Participant Flow|Dupilumab|An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
10777926|NCT03359356|OG000|Outcome|Placebo Then Dupilumab|Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
10777927|NCT03359356|OG001|Outcome|Dupilumab|An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
10777928|NCT03359356|OG000|Outcome|Placebo Then Dupilumab|Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks, an initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 24 doses.
10777929|NCT03359356|OG001|Outcome|Dupilumab|An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week, A total of 24 doses
10777930|NCT03359356|OG001|Outcome|Dupilumab|An initial dose of 600 mg (two 300 mg subcutaneous An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.), followed by 300 mg given every other week, A total of 24 doses
10777931|NCT03359356|OG000|Outcome|Placebo|Matching placebo in prefilled syringes identical to the dupilumab syringes. A total of 24 doses
10777932|NCT03359356|EG000|Reported Event|Placebo|Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo
10777933|NCT03359356|EG001|Reported Event|Dupilumab|Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
10777934|NCT03252925|BG000|Baseline|NAC Group|N-Acetylcysteine 50mg/Kg.d, oral
10777935|NCT03252925|BG001|Baseline|Placebo Group|Placebo oral tablet 50mg/Kg.d, oral
10777936|NCT03252925|BG002|Baseline|Total|Total of all reporting groups
10777937|NCT03252925|FG000|Participant Flow|Experimental Group|"N-Acetylcysteine~N-Acetylcysteine: 50mg/Kg.d, oral"
10777938|NCT03252925|FG001|Participant Flow|Control Group|"Placebo Oral Tablet~Placebo Oral Tablet: 50mg/Kg.d, oral"
10777939|NCT03252925|OG000|Outcome|NAC Group|N-Acetylcysteine 50mg/Kg.d, oral
10777940|NCT03252925|OG001|Outcome|Placebo Group|Placebo Oral Tablet 50mg/Kg.d, oral
10777941|NCT03252925|EG000|Reported Event|NAC Group|N-Acetylcysteine 50mg/Kg.d, oral
10777942|NCT03252925|EG001|Reported Event|Placebo|Placebo Oral Tablet 50mg/Kg.d, oral
10777943|NCT03185832|BG000|Baseline|CRT-D Cohort|This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
10777944|NCT03185832|BG001|Baseline|ICD Cohort|This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
10777945|NCT03185832|BG002|Baseline|Pacing Cohort|This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
10777946|NCT03185832|BG003|Baseline|Non-device Cohort|Patient enrolled but not implanted with a Defibrillator or Pacemaker
10777947|NCT03185832|BG004|Baseline|Total|Total of all reporting groups
10777948|NCT03185832|FG000|Participant Flow|CRT-D Cohort|This subject cohort is made by all patients enrolled and implanted with cardiac resynchronization therapy defibrillator (CRT-D)
10777949|NCT03185832|FG001|Participant Flow|ICD Cohort|This subject cohort is made by all patients enrolled and implanted with implantable cardioverter-defibrillator (ICD)
10777950|NCT03185832|FG002|Participant Flow|Pacing Cohort|This subject cohort is made by all patients enrolled and implanted with pacemakers (PM) with or without cardiac resynchronization therapy (CRT) capabilities
10777951|NCT03185832|FG003|Participant Flow|Non-device Cohort|Patient enrolled but not implanted with a Defibrillator or Pacemaker
10777952|NCT03185832|OG000|Outcome|CRT-D Cohort|This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
10777953|NCT03185832|OG001|Outcome|ICD Cohort|This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
10777954|NCT03185832|OG000|Outcome|Pacing Cohort|This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
10777955|NCT03185832|OG000|Outcome|Non-device Cohort|Patient enrolled but not implanted with a Defibrillator or Pacemaker
10777956|NCT03185832|OG002|Outcome|Pacing Cohort|This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
10777957|NCT03185832|EG000|Reported Event|Actively Enrolled Patients|Patients actively enrolled in the study, defined as subjects who met all eligibility criteria and who signed informed consent
10801037|NCT02920476|EG000|Reported Event|Treatment Arm|"TAS-102~TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.~Days 6 through 7: Rest~Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.~Days 13 through 28: Rest"
10801038|NCT02875860|BG000|Baseline|Standardized Postnatal Care (Expectant)|"Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10850900|NCT03999554|BG003|Baseline|Low Dose Bris10 M2SR|"Low dose Bris10 M2SR will be administered intranasally on days 1 and 29~LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10964397|NCT00877058|BG002|Baseline|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
10964398|NCT00877058|BG003|Baseline|Total|Total of all reporting groups
10964399|NCT00877058|FG000|Participant Flow|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
10777958|NCT02963714|BG000|Baseline|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777959|NCT02963714|BG001|Baseline|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777960|NCT02963714|BG002|Baseline|Total|Total of all reporting groups
10777961|NCT02963714|FG000|Participant Flow|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777962|NCT02963714|FG001|Participant Flow|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777963|NCT02963714|OG000|Outcome|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777964|NCT02963714|OG001|Outcome|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777965|NCT02963714|EG000|Reported Event|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777966|NCT02963714|EG001|Reported Event|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10777967|NCT02959918|BG000|Baseline|SEL-037 (Pegadricase) Low Dose|Pegardricase 0.2 mg/kg every 28 days for up to 5 doses
10777968|NCT02959918|BG001|Baseline|SEL-037 (Pegadricase) High Dose|Pegardricase 0.4 mg/kg every 28 days for up to 5 doses
10966593|NCT00887640|EG000|Reported Event|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
11240913|NCT02482805|BG000|Baseline|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10777969|NCT02959918|BG002|Baseline|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777970|NCT02959918|BG003|Baseline|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777971|NCT02959918|BG004|Baseline|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777972|NCT02959918|BG005|Baseline|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777973|NCT02959918|BG006|Baseline|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777974|NCT02959918|BG007|Baseline|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777975|NCT02959918|BG008|Baseline|SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777976|NCT02959918|BG009|Baseline|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777977|NCT02959918|BG010|Baseline|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777978|NCT02959918|BG011|Baseline|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10777979|NCT02959918|BG012|Baseline|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses|SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 Dose Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 4 Doses
10777980|NCT02959918|BG013|Baseline|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10777981|NCT02959918|BG014|Baseline|Total|Total of all reporting groups
10777982|NCT02959918|FG000|Participant Flow|SEL-037 (Pegadricase) Low Dose|Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
10777983|NCT02959918|FG001|Participant Flow|SEL-037 (Pegadricase) High Dose|Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
10777984|NCT02959918|FG002|Participant Flow|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777985|NCT02959918|FG003|Participant Flow|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777986|NCT02959918|FG004|Participant Flow|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777987|NCT02959918|FG005|Participant Flow|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777988|NCT02959918|FG006|Participant Flow|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777989|NCT02959918|FG007|Participant Flow|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777990|NCT02959918|FG008|Participant Flow|SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777991|NCT02959918|FG009|Participant Flow|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777992|NCT02959918|FG010|Participant Flow|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10777993|NCT02959918|FG011|Participant Flow|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10777994|NCT02959918|FG012|Participant Flow|SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 dose then SEL-110 (0.1 mg/kg) + Pegadricase 0.2 mg/kg every 28 days for 4 doses
10777995|NCT02959918|FG013|Participant Flow|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10777996|NCT02959918|OG000|Outcome|SEL-037 (Pegadricase) Low Dose|Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
10777997|NCT02959918|OG001|Outcome|SEL-037 (Pegadricase) High Dose|Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
10777998|NCT02959918|OG002|Outcome|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10777999|NCT02959918|OG003|Outcome|SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10778000|NCT02959918|OG004|Outcome|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
10778001|NCT02959918|OG005|Outcome|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10778002|NCT02959918|OG006|Outcome|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10778003|NCT02959918|OG007|Outcome|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10850901|NCT03999554|BG004|Baseline|Placebo|"Saline will be administered intranasally on days 1 and 29~Placebo: This group will receive saline placebo administered intranasally."
10850902|NCT03999554|BG005|Baseline|Total|Total of all reporting groups
10850903|NCT03999554|FG000|Participant Flow|Low Dose Sing2016 M2SR|"Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29~LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10778004|NCT02959918|OG008|Outcome|SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10778005|NCT02959918|OG009|Outcome|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
10778006|NCT02959918|OG010|Outcome|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
10778007|NCT02959918|OG011|Outcome|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10778008|NCT02959918|OG012|Outcome|SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses|SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
10778009|NCT02959918|OG013|Outcome|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
10778010|NCT02959918|OG000|Outcome|SEL-037 (Pegadricase)|SEL-037 every 28 days for up to 5 doses
10778011|NCT02959918|OG001|Outcome|SEL-212 for 3 Doses Followed by SEL-037 for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 3 doses followed by SEL-037 every 28 days for 2 doses
10778012|NCT02959918|OG002|Outcome|SEL-212 for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 5 doses
10778013|NCT02959918|EG000|Reported Event|SEL-037 (Pegadricase) Low Dose|Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
10778014|NCT02959918|EG001|Reported Event|SEL-037 (Pegadricase) High Dose|Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses
10778015|NCT02959918|EG002|Reported Event|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
10778016|NCT02959918|EG003|Reported Event|SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
10778017|NCT02959918|EG004|Reported Event|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
10778018|NCT02959918|EG005|Reported Event|SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
10778019|NCT02959918|EG006|Reported Event|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
10778020|NCT02959918|EG007|Reported Event|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
10778021|NCT02959918|EG008|Reported Event|SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
10778022|NCT02959918|EG009|Reported Event|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
10778023|NCT02959918|EG010|Reported Event|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
10778024|NCT02959918|EG011|Reported Event|SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
10778025|NCT02959918|EG012|Reported Event|SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days
10778026|NCT02959918|EG013|Reported Event|SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses|SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
10849937|NCT00299182|OG001|Outcome|ARM A 3mcg/kg|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10850904|NCT03999554|FG001|Participant Flow|Medium Dose Sing2016 M2SR|"Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29~MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10778027|NCT02472964|BG000|Baseline|Herceptin© + Taxane|"Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .~Herceptin© 8mg/kg Iv over 90 minutes x 1 then Herceptin© 6 mg/kg IV over 30 minutes every 3 weeks~Paclitaxel 80mg/m2 IV over 60 minutes weekly.~Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle"
10778028|NCT02472964|BG001|Baseline|MYL-1401O + Taxane|"Part 1:MYL-1401O intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O alone once every 3 weeks until DP or subject withdrawal.~MYL-1401O 8mg/kg Iv over 90 minutes x 1 then MYL-1401O 6 mg/kg IV over 30 minutes every 3 weeks~Paclitaxel 80mg/m2 IV over 60 minutes weekly.~Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle"
10778029|NCT02472964|BG002|Baseline|Total|Total of all reporting groups
10778030|NCT02472964|FG000|Participant Flow|Herceptin© + Taxane|"Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal ."
10778031|NCT02472964|FG001|Participant Flow|HerMyl 1401O Trastuzumab + Taxane|"Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal."
10778032|NCT02472964|OG000|Outcome|Herceptin© + Taxane|"Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal ."
10778033|NCT02472964|OG001|Outcome|MYL-1401O Trastuzumab + Taxane|"Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal."
10778034|NCT02472964|EG000|Reported Event|Herceptin© + Taxane|"Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal ."
10778035|NCT02472964|EG001|Reported Event|Myl 1401O Trastuzumab + Taxane|"Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.~Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal."
10778036|NCT02178722|BG000|Baseline|Phase 1: Epacadostat 25 mg BID|Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778037|NCT02178722|BG001|Baseline|Phase 1: Epacadostat 50 mg BID|Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778038|NCT02178722|BG002|Baseline|Phase 1: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778039|NCT02178722|BG003|Baseline|Phase 1: Epacadostat 300 mg BID|Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778040|NCT02178722|BG004|Baseline|Phase 2: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
10778041|NCT02178722|BG005|Baseline|Total|Total of all reporting groups
10778042|NCT02178722|FG000|Participant Flow|Phase 1: Epacadostat 25 mg BID|Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778043|NCT02178722|FG001|Participant Flow|Phase 1: Epacadostat 50 mg BID|Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778044|NCT02178722|FG002|Participant Flow|Phase 1: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778045|NCT02178722|FG003|Participant Flow|Phase 1: Epacadostat 300 mg BID|Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778046|NCT02178722|FG004|Participant Flow|Phase 2: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
10778047|NCT02178722|OG000|Outcome|Phase 1: Epacadostat 25 mg BID|Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778048|NCT02178722|OG001|Outcome|Phase 1: Epacadostat 50 mg BID|Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778049|NCT02178722|OG002|Outcome|Phase 1: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778050|NCT02178722|OG003|Outcome|Phase 1: Epacadostat 300 mg BID|Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778051|NCT02178722|OG000|Outcome|Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W|Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
10778052|NCT02178722|OG000|Outcome|Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W|Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778053|NCT02178722|OG000|Outcome|Phase 2: Epacadostat 100 mg BID|Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
10778054|NCT02178722|EG000|Reported Event|Phase 1: Epacadostat 25 mg BID|Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778055|NCT02178722|EG001|Reported Event|Phase 1: Epacadostat 50 MG BID|Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
10778056|NCT02178722|EG002|Reported Event|Phase 1: Epacadostat 100 MG BID|Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
10778057|NCT02178722|EG003|Reported Event|Phase 1: Epacadostat 300 MG BID|Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
10778058|NCT02178722|EG004|Reported Event|Phase 2: Epacadostat 100 MG BID|Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
10778059|NCT02178722|EG005|Reported Event|Total|Total
10778060|NCT01258803|BG000|Baseline|All Randomized Participants|
10778061|NCT01258803|FG000|Participant Flow|Treatment Sequence 1|Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
10778062|NCT01258803|FG001|Participant Flow|Treatment Sequence 2|Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
10778063|NCT01258803|FG002|Participant Flow|Treatment Sequence 3|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
10778064|NCT01258803|FG003|Participant Flow|Treatment Sequence 4|Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
10778065|NCT01258803|FG004|Participant Flow|Treatment Sequence 5|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
10778066|NCT01258803|FG005|Participant Flow|Treatment Sequence 6|Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
10778067|NCT01258803|OG000|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
10778068|NCT01258803|OG001|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
10778069|NCT01258803|OG000|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
10778070|NCT01258803|OG001|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
10778071|NCT01258803|OG002|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
10778072|NCT01258803|OG003|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
10778073|NCT01258803|OG001|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
10778074|NCT01258803|OG000|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
10778075|NCT01258803|EG000|Reported Event|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
10778076|NCT01258803|EG001|Reported Event|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
10778077|NCT01258803|EG002|Reported Event|F DPI|Participants receiving a single dose of F DPI 20 mcg
10778078|NCT01258803|EG003|Reported Event|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
10778079|NCT01104922|BG000|Baseline|Cetuximab and Stereotactic Radiosurgery|"Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.~Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)"
10778080|NCT01104922|FG000|Participant Flow|Cetuximab and Stereotactic Radiosurgery|"Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.~Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)"
10850535|NCT00303316|EG000|Reported Event|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10778081|NCT01104922|OG000|Outcome|Cetuximab and Stereotactic Radiosurgery|"Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.~Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)"
10778082|NCT01104922|EG000|Reported Event|Cetuximab and Stereotactic Radiosurgery|"Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.~Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)"
10778083|NCT00862251|BG000|Baseline|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
10778084|NCT00862251|BG001|Baseline|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
10778085|NCT00862251|BG002|Baseline|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
10778086|NCT00862251|BG003|Baseline|Total|Total of all reporting groups
10778087|NCT00862251|FG000|Participant Flow|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
10778088|NCT00862251|FG001|Participant Flow|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
10778089|NCT00862251|FG002|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
10778090|NCT00862251|OG000|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
10778091|NCT00862251|OG001|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
10778092|NCT00862251|OG001|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
10778093|NCT00862251|OG001|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
10778094|NCT00862251|OG001|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
10778095|NCT00862251|OG002|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
10778096|NCT00862251|EG000|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
10778097|NCT00862251|EG001|Reported Event|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
10778098|NCT00862251|EG002|Reported Event|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
10778099|NCT00783263|BG000|Baseline|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
10778100|NCT00783263|BG001|Baseline|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778101|NCT00783263|BG002|Baseline|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778102|NCT00783263|BG003|Baseline|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778103|NCT00783263|BG004|Baseline|Total|Total of all reporting groups
10778104|NCT00783263|FG000|Participant Flow|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
10778105|NCT00783263|FG001|Participant Flow|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778106|NCT00783263|FG002|Participant Flow|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778107|NCT00783263|FG003|Participant Flow|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778108|NCT00783263|OG000|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
10778109|NCT00783263|OG001|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
10778110|NCT00783263|OG000|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
10778111|NCT00783263|OG001|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778112|NCT00783263|OG002|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778113|NCT00783263|OG003|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778114|NCT00783263|OG000|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
10778115|NCT00783263|OG001|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
10778116|NCT00783263|OG000|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778117|NCT00783263|OG001|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778118|NCT00783263|OG002|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778119|NCT00783263|OG000|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
11193255|NCT02144012|EG000|Reported Event|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
11193256|NCT02144012|EG001|Reported Event|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
11193257|NCT02144077|BG000|Baseline|BF-200 ALA|Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
10778120|NCT00783263|OG001|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
10778121|NCT00783263|OG000|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
10778122|NCT00783263|OG001|Outcome|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778123|NCT00783263|OG002|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778124|NCT00783263|OG003|Outcome|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778125|NCT00783263|EG000|Reported Event|Rosuva 5 mg + EZ 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
10778126|NCT00783263|EG001|Reported Event|Rosuva 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
10778127|NCT00783263|EG002|Reported Event|Rosuva 10 mg + EZ 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
10778128|NCT00783263|EG003|Reported Event|Rosuva 20 mg|Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
10778129|NCT00782184|BG000|Baseline|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
10778130|NCT00782184|BG001|Baseline|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
10778131|NCT00782184|BG002|Baseline|Total|Total of all reporting groups
10778132|NCT00782184|FG000|Participant Flow|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
11202197|NCT02205983|OG002|Outcome|1000 mg Acetaminophen|"Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.~1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task."
11202198|NCT02205983|OG003|Outcome|Dextrose|"Healthy adult volunteers will recieve Dextrose (placebo).~dextrose: We are administering dextrose to healthy volunteers for our placebo group."
10778133|NCT00782184|FG001|Participant Flow|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
10778134|NCT00782184|OG000|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
10778135|NCT00782184|OG001|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
10778136|NCT00782184|EG000|Reported Event|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
10778137|NCT00782184|EG001|Reported Event|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
10778138|NCT00782184|EG002|Reported Event|Placebo|One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period.
10778139|NCT00635882|BG000|Baseline|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
10778140|NCT00635882|BG001|Baseline|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
10778141|NCT00635882|BG002|Baseline|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
10778142|NCT00635882|BG003|Baseline|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
10778143|NCT00635882|BG004|Baseline|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
10778144|NCT00635882|BG005|Baseline|Placebo|Placebo MDI BID for 14 days
10778145|NCT00635882|BG006|Baseline|Total|Total of all reporting groups
10778146|NCT00635882|FG000|Participant Flow|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
10778147|NCT00635882|FG001|Participant Flow|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
10778148|NCT00635882|FG002|Participant Flow|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
10778149|NCT00635882|FG003|Participant Flow|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
10778150|NCT00635882|FG004|Participant Flow|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
10778151|NCT00635882|FG005|Participant Flow|Placebo|Placebo MDI BID for 14 days
10778152|NCT00635882|OG000|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
10778153|NCT00635882|OG001|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
11202199|NCT02205983|EG000|Reported Event|2 mg Hydromophone|"Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.~2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task."
11240914|NCT02482805|BG001|Baseline|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778154|NCT00635882|OG002|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
10778155|NCT00635882|OG003|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
10778156|NCT00635882|OG004|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
10778157|NCT00635882|OG005|Outcome|Placebo|Placebo MDI BID for 14 days
10778158|NCT00635882|EG000|Reported Event|MF/F MDI 100/10 MCG BID|
10778159|NCT00635882|EG001|Reported Event|MF/F MDI 200/10 MCG BID|
10778160|NCT00635882|EG002|Reported Event|MF/F MDI 400/10 MCG BID|
10778161|NCT00635882|EG003|Reported Event|MF DPI 200 MCG BID|
10778162|NCT00635882|EG004|Reported Event|MF MDI 200 MCG BID|
10778163|NCT00635882|EG005|Reported Event|PLACEBO|
10778164|NCT00594620|BG000|Baseline|Arm 1/ Soy Supplementation|"Subjects receive supplement~Flav-ein capsules: Soy/isoflavone supplementation"
10778165|NCT00594620|BG001|Baseline|Arm 2/ Placebo|"Subjects will receive placebo~Placebo: Placebo"
10778166|NCT00594620|BG002|Baseline|Total|Total of all reporting groups
10778167|NCT00594620|FG000|Participant Flow|Arm 1/ Soy Supplementation|"Subjects receive supplement~Flav-ein capsules: Soy/isoflavone supplementation"
10778168|NCT00594620|FG001|Participant Flow|Arm 2/ Placebo|"Subjects will receive placebo~Placebo: Placebo"
10778169|NCT00594620|OG000|Outcome|Flav-ein Capsules|"Subjects receive supplement~Flav-ein capsules: Soy/isoflavone supplementation"
10778170|NCT00594620|OG001|Outcome|Placebo|"Subjects will receive placebo~Placebo: Placebo"
10778171|NCT00594620|EG000|Reported Event|Flav-ein Capsules|"Subjects receive supplement~Flav-ein capsules: Soy/isoflavone supplementation"
10778172|NCT00594620|EG001|Reported Event|Placebo|"Subjects will receive placebo~Placebo: Placebo"
10778173|NCT00535405|BG000|Baseline|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
10778174|NCT00535405|BG001|Baseline|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
10778175|NCT00535405|BG002|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
10778176|NCT00535405|BG003|Baseline|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
10778177|NCT00535405|BG004|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
10778178|NCT00535405|BG005|Baseline|Total|Total of all reporting groups
10778179|NCT00535405|FG000|Participant Flow|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
10778180|NCT00535405|FG001|Participant Flow|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
10778181|NCT00535405|FG002|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
10778182|NCT00535405|FG003|Participant Flow|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
10778183|NCT00535405|FG004|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
10778184|NCT00535405|OG000|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
10778185|NCT00535405|OG001|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
10778186|NCT00535405|OG002|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
10778187|NCT00535405|OG003|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
10778188|NCT00535405|OG004|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
10778189|NCT00535405|EG000|Reported Event|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
10778190|NCT00535405|EG001|Reported Event|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
10778191|NCT00535405|EG002|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
10778192|NCT00535405|EG003|Reported Event|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
10778193|NCT00535405|EG004|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily for 12 weeks
10778194|NCT00496730|BG000|Baseline|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
10778195|NCT00496730|BG001|Baseline|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
10778196|NCT00496730|BG002|Baseline|Total|Total of all reporting groups
10778197|NCT00496730|FG000|Participant Flow|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
10778198|NCT00496730|FG001|Participant Flow|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
10778199|NCT00496730|OG000|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
10778200|NCT00496730|OG001|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
10778201|NCT00496730|EG000|Reported Event|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
10778202|NCT00496730|EG001|Reported Event|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
10778203|NCT00462748|BG000|Baseline|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
10778204|NCT00462748|BG001|Baseline|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
10778205|NCT00462748|BG002|Baseline|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
10778206|NCT00462748|BG003|Baseline|Total|Total of all reporting groups
10778207|NCT00462748|FG000|Participant Flow|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
10778208|NCT00462748|FG001|Participant Flow|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
10778209|NCT00462748|FG002|Participant Flow|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
10778210|NCT00462748|OG000|Outcome|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
10778211|NCT00462748|OG001|Outcome|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
10778212|NCT00462748|OG002|Outcome|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
10778213|NCT00462748|EG000|Reported Event|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
10778214|NCT00462748|EG001|Reported Event|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
10778215|NCT00462748|EG002|Reported Event|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
10778216|NCT00418834|BG000|Baseline|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
10778217|NCT00418834|BG001|Baseline|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
10778218|NCT00418834|BG002|Baseline|Total|Total of all reporting groups
10778219|NCT00418834|FG000|Participant Flow|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
10778220|NCT00418834|FG001|Participant Flow|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
10778221|NCT00418834|OG000|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
10778222|NCT00418834|OG001|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
10778223|NCT00418834|EG000|Reported Event|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
10778224|NCT00418834|EG001|Reported Event|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
10778225|NCT00409773|BG000|Baseline|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
10778226|NCT00409773|BG001|Baseline|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
10778227|NCT00409773|BG002|Baseline|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
10778228|NCT00409773|BG003|Baseline|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
10778229|NCT00409773|BG004|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
10778230|NCT00409773|BG005|Baseline|Total|Total of all reporting groups
10778231|NCT00409773|FG000|Participant Flow|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
10778232|NCT00409773|FG001|Participant Flow|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
10778233|NCT00409773|FG002|Participant Flow|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
10778234|NCT00409773|FG003|Participant Flow|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
10778235|NCT00409773|FG004|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
10778236|NCT00409773|OG000|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
10778237|NCT00409773|OG001|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
10778238|NCT00409773|OG002|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
10778239|NCT00409773|OG003|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
10778240|NCT00409773|OG004|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
10778241|NCT00409773|EG000|Reported Event|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
10778242|NCT00409773|EG001|Reported Event|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
10778243|NCT00409773|EG002|Reported Event|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
10778244|NCT00409773|EG003|Reported Event|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
10778245|NCT00409773|EG004|Reported Event|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
10778246|NCT00276484|BG000|Baseline|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
10778247|NCT00276484|BG001|Baseline|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
10778248|NCT00276484|BG002|Baseline|Total|Total of all reporting groups
10778249|NCT00276484|FG000|Participant Flow|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
10778250|NCT00276484|FG001|Participant Flow|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
10778251|NCT00276484|OG000|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
10778252|NCT00276484|OG001|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
10778253|NCT00276484|EG000|Reported Event|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
10778254|NCT00276484|EG001|Reported Event|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
10778255|NCT00276458|BG000|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
10778256|NCT00276458|BG001|Baseline|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
10778257|NCT00276458|BG002|Baseline|Total|Total of all reporting groups
10778258|NCT00276458|FG000|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
10778259|NCT00276458|FG001|Participant Flow|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
10778260|NCT00276458|OG000|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
10778261|NCT00276458|OG001|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
10778262|NCT00276458|EG000|Reported Event|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
10778263|NCT00276458|EG001|Reported Event|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
10778264|NCT00271817|BG000|Baseline|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
10778265|NCT00271817|BG001|Baseline|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
10778266|NCT00271817|BG002|Baseline|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
10778267|NCT00271817|BG003|Baseline|Total|Total of all reporting groups
10778268|NCT00271817|FG000|Participant Flow|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
10778269|NCT00271817|FG001|Participant Flow|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
10778270|NCT00271817|FG002|Participant Flow|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
10778271|NCT00271817|OG000|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
10778272|NCT00271817|OG001|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
10778273|NCT00271817|OG000|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
10778274|NCT00271817|OG000|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
10778275|NCT00271817|OG001|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
10778276|NCT00271817|EG000|Reported Event|Niacin|Niacin group from Part 1
10778277|NCT00271817|EG001|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin group from Part 1
10778278|NCT00271817|EG002|Reported Event|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin + Niacin group from Part 1
10778279|NCT00271817|EG003|Reported Event|Ezetimibe/Simvastatin - Part 2|EZ/Simva group from Part 2 All-Treated Patient as Treated Population
10778280|NCT00271817|EG004|Reported Event|Ezetimibe/Simvastatin + Niacin - Part 2|Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
11193258|NCT02144077|BG001|Baseline|Methyl-aminolevulinate|Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193259|NCT02144077|BG002|Baseline|Total|Total of all reporting groups
11193260|NCT02144077|FG000|Participant Flow|BF-200 ALA|Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193261|NCT02144077|FG001|Participant Flow|Methyl-aminolevulinate|Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193262|NCT02144077|OG000|Outcome|BF-200 ALA|Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11378991|NCT04209621|BG000|Baseline|Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Duvelisib with ibrutinib will be administered for the first six 28-day (± 7) cycles followed by duvelisib alone until disease progression or intolerance. Duvelisib is an orally administered at 15 mg twice a day (dose level 1) or 25 mg twice day (dose level 2). Subjects will continue the same dose of ibrutinib prior to study enrollment for the first six 28-day cycles. Ibrutinib is an orally administered and provided as 140 mg white opaque capsules or tablets in 4 strengths: 140 mg, 280 mg, 420 mg, and 560 mg.
11378992|NCT04209621|FG000|Participant Flow|Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Duvelisib with ibrutinib will be administered for the first six 28-day (± 7) cycles followed by duvelisib alone until disease progression or intolerance. Duvelisib is an orally administered at 15 mg twice a day (dose level 1) or 25 mg twice day (dose level 2). Subjects will continue the same dose of ibrutinib prior to study enrollment for the first six 28-day cycles. Ibrutinib is an orally administered and provided as 140 mg white opaque capsules or tablets in 4 strengths: 140 mg, 280 mg, 420 mg, and 560 mg.
11378993|NCT04209621|OG000|Outcome|Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Duvelisib with ibrutinib will be administered for the first six 28-day (± 7) cycles followed by duvelisib alone until disease progression or intolerance. Duvelisib is an orally administered at 15 mg twice a day (dose level 1) or 25 mg twice day (dose level 2). Subjects will continue the same dose of ibrutinib prior to study enrollment for the first six 28-day cycles. Ibrutinib is an orally administered and provided as 140 mg white opaque capsules or tablets in 4 strengths: 140 mg, 280 mg, 420 mg, and 560 mg.
11378994|NCT04209621|OG000|Outcome|Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Duvelisib with ibrutinib will be administered for the first six 28-day (± 7) cycles followed by duvelisib alone until disease progression or intolerance. Duvelisib is an orally administered at 15 mg twice a day (dose level 1) or 25 mg twice day (dose level 2) or. Subjects will continue the same dose of ibrutinib prior to study enrollment for the first six 28-day cycles. Ibrutinib is an orally administered and provided as 140 mg white opaque capsules or tablets in 4 strengths: 140 mg, 280 mg, 420 mg, and 560 mg.
10850536|NCT00303316|EG001|Reported Event|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
10778281|NCT03660865|BG000|Baseline|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.~Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments"
10778282|NCT03660865|BG001|Baseline|Control IOL|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.~Control IOL: Fellow eye will receive control IOL"
10778283|NCT03660865|BG002|Baseline|Total|Total of all reporting groups
10778284|NCT03660865|FG000|Participant Flow|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.~Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments"
10778285|NCT03660865|FG001|Participant Flow|Control IOL|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.~Control IOL: Fellow eye will receive control IOL"
10778286|NCT03660865|OG000|Outcome|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.~Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments"
10778287|NCT03660865|OG001|Outcome|Control IOL|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.~Control IOL: Fellow eye will receive control IOL"
10778288|NCT03660865|EG000|Reported Event|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.~Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments"
10778289|NCT03660865|EG001|Reported Event|Control IOL|"A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.~Control IOL: Fellow eye will receive control IOL"
10778290|NCT03493126|BG000|Baseline|Estradiol|"Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Estradiol: 17β-estradiol vaginal cream"
10778291|NCT03493126|BG001|Baseline|Placebo|"Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Placebo: Compounded placebo cream"
10778292|NCT03493126|BG002|Baseline|Total|Total of all reporting groups
10778293|NCT03493126|FG000|Participant Flow|Estradiol|"Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Estradiol: 17β-estradiol vaginal cream"
10778294|NCT03493126|FG001|Participant Flow|Placebo|"Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Placebo: Compounded placebo cream"
10778295|NCT03493126|OG000|Outcome|Estradiol|"Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Estradiol: 17β-estradiol vaginal cream"
10778296|NCT03493126|OG001|Outcome|Placebo|"Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Placebo: Compounded placebo cream"
10778297|NCT03493126|EG000|Reported Event|Estradiol|"Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Estradiol: 17β-estradiol vaginal cream"
10778298|NCT03493126|EG001|Reported Event|Placebo|"Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.~Placebo: Compounded placebo cream"
10778299|NCT03420781|BG000|Baseline|Treatment Period: Placebo|Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
10778300|NCT03420781|BG001|Baseline|Treatment Period: Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
10778301|NCT03420781|BG002|Baseline|Total|Total of all reporting groups
10778302|NCT03420781|FG000|Participant Flow|Treatment Period: Placebo|Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
10778303|NCT03420781|FG001|Participant Flow|Treatment Period: Relamorelin 10 μg|Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
10778304|NCT03420781|FG002|Participant Flow|Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg|Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
10778305|NCT03420781|FG003|Participant Flow|Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778306|NCT03420781|FG004|Participant Flow|Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778307|NCT03420781|OG000|Outcome|Treatment Period: Placebo|Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
10778308|NCT03420781|OG001|Outcome|Treatment Period: Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
10778309|NCT03420781|OG000|Outcome|Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg|Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.
10778310|NCT03420781|OG001|Outcome|Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
10850537|NCT00303329|BG000|Baseline|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
10778311|NCT03420781|OG002|Outcome|Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778312|NCT03420781|OG002|Outcome|Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg|Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.
10778313|NCT03420781|OG003|Outcome|Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778314|NCT03420781|OG004|Outcome|Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778315|NCT03420781|OG000|Outcome|Treatment Period: Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
10778316|NCT03420781|EG000|Reported Event|Treatment Period: Placebo|Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
10778317|NCT03420781|EG001|Reported Event|Treatment Period: Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
10778318|NCT03420781|EG002|Reported Event|Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg|Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the RW Period.
10778319|NCT03420781|EG003|Reported Event|Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778320|NCT03420781|EG004|Reported Event|Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo|Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
10778321|NCT03316586|BG000|Baseline|Nivolumab + Cabozantinib|"Nivolumab was administered every 28 days at a dose of 480mg given intravenously over 30 minutes (+/- 10 minutes) using a volumetric pump with 0.2 to 1.2 micron pore size, low protein binding polyethersulfone membrane in-line filter~Cabozantinib was administered orally, once daily for 28 days at a dose of 40 mg.~Nivolumab: Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.~Cabozantinib: Cabozantinib may help to shrink or stabilize breast cancer"
11202200|NCT02205983|EG001|Reported Event|4 mg Hydromphone|"Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion~4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task."
11240915|NCT02482805|BG002|Baseline|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
11240916|NCT02482805|BG003|Baseline|Total|Total of all reporting groups
10778322|NCT03316586|FG000|Participant Flow|Nivolumab + Cabozantinib|"Nivolumab was administered every 28 days at a dose of 480mg given intravenously over 30 minutes (+/- 10 minutes) using a volumetric pump with 0.2 to 1.2 micron pore size, low protein binding polyethersulfone membrane in-line filter~Cabozantinib was administered orally, once daily for 28 days at a dose of 40 mg.~Nivolumab: Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.~Cabozantinib: Cabozantinib may help to shrink or stabilize breast cancer"
10778323|NCT03316586|OG000|Outcome|Nivolumab + Cabozantinib|"Nivolumab was administered every 28 days at a dose of 480mg given intravenously over 30 minutes (+/- 10 minutes) using a volumetric pump with 0.2 to 1.2 micron pore size, low protein binding polyethersulfone membrane in-line filter~Cabozantinib was administered orally, once daily for 28 days at a dose of 40 mg.~Nivolumab: Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.~Cabozantinib: Cabozantinib may help to shrink or stabilize breast cancer"
10778324|NCT03316586|EG000|Reported Event|Nivolumab + Cabozantinib|"Nivolumab was administered every 28 days at a dose of 480mg given intravenously over 30 minutes (+/- 10 minutes) using a volumetric pump with 0.2 to 1.2 micron pore size, low protein binding polyethersulfone membrane in-line filter~Cabozantinib was administered orally, once daily for 28 days at a dose of 40 mg.~Nivolumab: Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.~Cabozantinib: Cabozantinib may help to shrink or stabilize breast cancer"
10778325|NCT03277066|BG000|Baseline|HP-5000-75α Patch (5% Diclofenac Sodium)|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s for 4-week treatment."
10778326|NCT03277066|BG001|Baseline|HP-5000-DRS400 Patch (5% Diclofenac Sodium)|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778327|NCT03277066|BG002|Baseline|Placebo Patch|Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
10778328|NCT03277066|BG003|Baseline|Total|Total of all reporting groups
10778329|NCT03277066|FG000|Participant Flow|Diclofenac Sodium Active Topical Patch 1|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778330|NCT03277066|FG001|Participant Flow|Diclofenac Sodium Active Topical Patch 2|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778331|NCT03277066|FG002|Participant Flow|Placebo Patch|Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
10778332|NCT03277066|OG000|Outcome|Diclofenac Sodium Active Topical Patch 1|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778333|NCT03277066|OG001|Outcome|Diclofenac Sodium Active Topical Patch 2|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 2 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778334|NCT03277066|OG002|Outcome|Placebo Patch|Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
10778335|NCT03277066|EG000|Reported Event|Diclofenac Sodium Active Topical Patch 1|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778336|NCT03277066|EG001|Reported Event|Diclofenac Sodium Active Topical Patch 2|"Diclofenac Sodium Active Topical Patch 1 and Diclofenac Sodium Active Topical Patch 2 contain the same amount of diclofenac sodium but in different formulations.~Diclofenac Sodium Active Topical Patch 1 was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment."
10778337|NCT03277066|EG002|Reported Event|Placebo Patch|Placebo patch was applied to the target knee on subjects with Osteoarthritis of the knee(s) for 4-week treatment.
10778338|NCT03269695|BG000|Baseline|Placebo + Infliximab|Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778339|NCT03269695|BG001|Baseline|PF-06687234 20 mg + Infliximab|PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778340|NCT03269695|BG002|Baseline|Total|Total of all reporting groups
10778341|NCT03269695|FG000|Participant Flow|Placebo + Infliximab|Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778342|NCT03269695|FG001|Participant Flow|PF-06687234 20 mg + Infliximab|PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778343|NCT03269695|OG000|Outcome|Placebo + Infliximab|Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778344|NCT03269695|OG001|Outcome|PF-06687234 20 mg + Infliximab|PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778345|NCT03269695|OG000|Outcome|PF-06687234 20 mg + Infliximab|PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
11240917|NCT02482805|FG000|Participant Flow|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778346|NCT03269695|EG000|Reported Event|Placebo + Infliximab|Placebo for PF-06687234 was administered as subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
11193263|NCT02144077|OG001|Outcome|Methyl-aminolevulinate|Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193264|NCT02144077|EG000|Reported Event|BF-200 ALA|Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193265|NCT02144077|EG001|Reported Event|Methyl-aminolevulinate|Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
11193266|NCT02144220|BG000|Baseline|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
11378995|NCT04209621|EG000|Reported Event|Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Duvelisib with ibrutinib will be administered for the first six 28-day (± 7) cycles followed by duvelisib alone until disease progression or intolerance. Duvelisib is an orally administered at 15 mg twice a day (dose level 1) or 25 mg twice day (dose level 2). Subjects will continue the same dose of ibrutinib prior to study enrollment for the first six 28-day cycles. Ibrutinib is an orally administered and provided as 140 mg white opaque capsules or tablets in 4 strengths: 140 mg, 280 mg, 420 mg, and 560 mg.
11378996|NCT04186663|BG000|Baseline|Advantage Arrest|"38% silver diamine fluoride, topical, 1 drop, single application~Silver Diamine Fluoride: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7"
11378997|NCT04186663|FG000|Participant Flow|Advantage Arrest|"38% silver diamine fluoride, topical, 1 drop, single application~Silver Diamine Fluoride: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7"
11378998|NCT04186663|OG000|Outcome|Advantage Arrest|"38% silver diamine fluoride, topical, 1 drop, single application~Silver Diamine Fluoride: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7"
11378999|NCT04186663|EG000|Reported Event|Advantage Arrest|"38% silver diamine fluoride, topical, 1 drop, single application~Silver Diamine Fluoride: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7"
10850538|NCT00303329|BG001|Baseline|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
10850539|NCT00303329|BG002|Baseline|Total|Total of all reporting groups
10850540|NCT00303329|FG000|Participant Flow|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
10850541|NCT00303329|FG001|Participant Flow|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
10850542|NCT00303329|OG000|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
11193267|NCT02144220|FG000|Participant Flow|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
11193268|NCT02144220|OG000|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
11379000|NCT04158219|BG000|Baseline|Treatment|"Behavioral activation for health and depression (BA-HD)~Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes)."
10850543|NCT00303329|OG001|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
10778347|NCT03269695|EG001|Reported Event|PF-06687234 20 mg + Infliximab|PF-06687234 was administered as a 20 mg subcutaneous injection on Day 1, Week 1 (Day 8), Week 2 (Day 15), Week 3 (Day 22), Week 4 (Day 29), Week 5 (Day 36), Week 6 (Day 43), Week 7 (Day 50), Week 8 (Day 57), Week 9 (Day 64), Week 10 (Day 71) and Week 11 (Day 78) for a total 12 doses. Remicade or protocol specified infliximab biosimilar was administered as an IV infusion on Day 1, Week 8 and Week 16 for a total of 3 doses for participants on infliximab every 8 weeks, and Day 1, Week 6, Week 12 and Week 18 for participants on infliximab every 6 weeks.
10778348|NCT03268811|BG000|Baseline|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778349|NCT03268811|BG001|Baseline|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778350|NCT03268811|BG002|Baseline|Total|Total of all reporting groups
10778351|NCT03268811|FG000|Participant Flow|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778352|NCT03268811|FG001|Participant Flow|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778353|NCT03268811|OG000|Outcome|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778354|NCT03268811|OG001|Outcome|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778355|NCT03268811|OG001|Outcome|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle (Cycles 1 to 9 [Each cycle=28 weeks]) depending on the disease course.
10778356|NCT03268811|EG000|Reported Event|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778357|NCT03268811|EG001|Reported Event|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course.
10778358|NCT03227757|BG000|Baseline|Tricuspid Valve Repair System|"Subjects who received TVRS will be included in this arm.~Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation."
10778359|NCT03227757|FG000|Participant Flow|Tricuspid Valve Repair System|"Subjects who received TVRS will be included in this arm.~Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation."
10778360|NCT03227757|OG000|Outcome|Tricuspid Valve Repair System|"Subjects who received TVRS will be included in this arm.~Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation."
10778361|NCT03227757|EG000|Reported Event|Tricuspid Valve Repair System|"Subjects who received TVRS will be included in this arm.~Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation."
10778362|NCT03222128|BG000|Baseline|PIIS3i - SAPIEN 3|"PIIS3i - SAPIEN 3 is Operable Group~TAVR: Implantation of the SAPIEN 3"
10778363|NCT03222128|FG000|Participant Flow|PIIS3i - SAPIEN 3|"PIIS3i - SAPIEN 3 is Operable Group~TAVR: Implantation of the SAPIEN 3"
10778364|NCT03222128|OG000|Outcome|PIIS3i - SAPIEN 3|"PIIS3i - SAPIEN 3 is Operable Group~TAVR: Implantation of the SAPIEN 3"
10778365|NCT03222128|EG000|Reported Event|PIIS3i - SAPIEN 3|"PIIS3i - SAPIEN 3 is Operable Group~TAVR: Implantation of the SAPIEN 3"
10778366|NCT03142334|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778367|NCT03142334|BG001|Baseline|Placebo|Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778368|NCT03142334|BG002|Baseline|Total|Total of all reporting groups
10778369|NCT03142334|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778370|NCT03142334|FG001|Participant Flow|Placebo|Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778371|NCT03142334|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778372|NCT03142334|OG001|Outcome|Placebo|Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
11193269|NCT02144220|EG000|Reported Event|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
11193270|NCT02144233|BG000|Baseline|Occlusal Adjustmen Therapy|"Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance angle on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.~Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure.~The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)"
11193271|NCT02144233|BG001|Baseline|Placebo Occlusal Adjustment Therapy|"Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.~Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed."
10778373|NCT03142334|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778374|NCT03142334|EG001|Reported Event|Placebo|Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
10778375|NCT03093701|BG000|Baseline|Group 1|"TLC399 (ProDex) 0.36mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778376|NCT03093701|BG001|Baseline|Group 2|"TLC399 (ProDex) 0.6 mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778377|NCT03093701|BG002|Baseline|Group 3|"TLC399 (ProDex) 0.6 mg DSP with 50 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
11193272|NCT02144233|BG002|Baseline|Total|Total of all reporting groups
11193273|NCT02144233|FG000|Participant Flow|Occlusal Adjustmen Therapy|"Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.~Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure.~The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)"
10778378|NCT03093701|BG003|Baseline|Total|Total of all reporting groups
10778379|NCT03093701|FG000|Participant Flow|Group 1|"TLC399 (ProDex) 0.36mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778380|NCT03093701|FG001|Participant Flow|Group 2|"TLC399 (ProDex) 0.6 mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778381|NCT03093701|FG002|Participant Flow|Group 3|"TLC399 (ProDex) 0.6 mg DSP with 50 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778382|NCT03093701|FG003|Participant Flow|Group 4|"TLC399 (ProDex) 0.84 mg DSP with 50 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778383|NCT03093701|OG000|Outcome|Group 1|"TLC399 (ProDex) 0.36mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
11240918|NCT02482805|FG001|Participant Flow|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778384|NCT03093701|OG001|Outcome|Group 2|"TLC399 (ProDex) 0.6 mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778385|NCT03093701|OG002|Outcome|Group 3|"TLC399 (ProDex) 0.6 mg DSP with 50 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778386|NCT03093701|EG000|Reported Event|Group 1|"TLC399 (ProDex) 0.36mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778387|NCT03093701|EG001|Reported Event|Group 2|"TLC399 (ProDex) 0.6 mg DSP with 100 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778388|NCT03093701|EG002|Reported Event|Group 3|"TLC399 (ProDex) 0.6 mg DSP with 50 mM PL~TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid"
10778389|NCT03093246|BG000|Baseline|Control Group|In this group (n = 19), patients received placebo pills over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
10778390|NCT03093246|BG001|Baseline|Test Group|In this group (n = 19), patients received 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
10778391|NCT03093246|BG002|Baseline|Total|Total of all reporting groups
10778392|NCT03093246|FG000|Participant Flow|Control Group|"In this group (n = 19), patients took placebo pills and full-mouth ultrasonic debridement was performed to treat diseased sites.~Placebo: Placebo pills over a period of 180 days~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites"
10778393|NCT03093246|FG001|Participant Flow|Test Group|"In this group (n = 19), patients took 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.~Omega-3 polyunsaturated fatty acids: 900 mg of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days~Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites"
10850544|NCT00303329|EG000|Reported Event|Beta-thalassemia|Deferasirox (5-40 mg/kg/day)
10850545|NCT00303329|EG001|Reported Event|Rare Anemias|Deferasirox (5-40 mg/kg/day)
10778394|NCT03093246|OG000|Outcome|Control Group|In this group (n = 19), patients took placebo pills over a period of 180 days and received full-mouth ultrasonic debridement to treat diseased sites.
10778395|NCT03093246|OG001|Outcome|Test Group|In this group (n = 19), patients will take 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
10778396|NCT03093246|EG000|Reported Event|Control Group|In this group (n = 19), patients took placebo pills over a period of 180 days and received full-mouth ultrasonic debridement to treat diseased sites.
10778397|NCT03093246|EG001|Reported Event|Test Group|In this group (n = 19), patients will take 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
10801039|NCT02875860|BG001|Baseline|Prenatal Intervention (FETO)|"Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.~GoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.~Baltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801040|NCT02875860|BG002|Baseline|Total|Total of all reporting groups
10801041|NCT02875860|FG000|Participant Flow|Standardized Postnatal Care (Expectant)|"Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801042|NCT02875860|FG001|Participant Flow|Prenatal Intervention (FETO)|"Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.~GoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.~Baltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801043|NCT02875860|OG000|Outcome|Standardized Postnatal Care (Expectant)|"Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801044|NCT02875860|OG001|Outcome|Prenatal Intervention (FETO)|"Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.~GoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.~Baltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801045|NCT02875860|EG000|Reported Event|Standardized Postnatal Care (Expectant)|"Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801046|NCT02875860|EG001|Reported Event|Prenatal Intervention (FETO)|"Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.~GoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.~Baltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.~Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622"
10801047|NCT02833844|BG000|Baseline|Double-Blind Placebo|Double-blind placebo SC injection QM for 24 weeks in the double-blind period.
10801048|NCT02833844|BG001|Baseline|Double-Blind Evolocumab|Double-blind evolocumab SC injection QM for 24 weeks in the double-blind period.
10801049|NCT02833844|BG002|Baseline|Total|Total of all reporting groups
10850546|NCT00303446|BG000|Baseline|Placebo|Matched placebo, one tablet daily
10778398|NCT02991599|BG000|Baseline|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778399|NCT02991599|BG001|Baseline|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778400|NCT02991599|BG002|Baseline|Total|Total of all reporting groups
10778401|NCT02991599|FG000|Participant Flow|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778402|NCT02991599|FG001|Participant Flow|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778403|NCT02991599|OG000|Outcome|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778404|NCT02991599|OG001|Outcome|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778405|NCT02991599|EG000|Reported Event|IM 20μg Group|Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778406|NCT02991599|EG001|Reported Event|IM 60μg Group|Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
10778407|NCT02976129|BG000|Baseline|V565|"V565 TID PO for 6 weeks~V565: Daily dosing of V565 three times a day orally for 6 weeks"
10778408|NCT02976129|BG001|Baseline|Placebo|"Placebo TID PO for 6 weeks~Placebo: Daily dosing of placebo three times a day orally for 6 weeks"
10778409|NCT02976129|BG002|Baseline|Total|Total of all reporting groups
10778410|NCT02976129|FG000|Participant Flow|V565|"V565 three times daily (TID) PO for 6 weeks~V565: Daily dosing of V565 three times a day orally for 6 weeks"
10778411|NCT02976129|FG001|Participant Flow|Placebo|"Placebo three times daily (TID) PO for 6 weeks~Placebo: Daily dosing of placebo three times a day orally for 6 weeks"
10778412|NCT02976129|OG000|Outcome|V565|"V565 TID PO for 6 weeks~V565: Daily dosing of V565 three times a day orally for 6 weeks"
11240919|NCT02482805|FG002|Participant Flow|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778413|NCT02976129|OG001|Outcome|Placebo|"Placebo TID PO for 6 weeks~Placebo: Daily dosing of placebo three times a day orally for 6 weeks"
10778414|NCT02976129|EG000|Reported Event|V565|"V565 TID PO for 6 weeks~V565: Daily dosing of V565 three times a day orally for 6 weeks"
11240920|NCT02482805|OG000|Outcome|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778415|NCT02976129|EG001|Reported Event|Placebo|"Placebo TID PO for 6 weeks~Placebo: Daily dosing of placebo three times a day orally for 6 weeks"
10778416|NCT02970136|BG000|Baseline|Home Based Screening|"The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker~OraQuick Swab: OraQuick for oral fluid HIV antibody testing~Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin~OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick~HPV Self-Sampling Test: Patients will be using swab to check for HPV infection~Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests"
10778417|NCT02970136|BG001|Baseline|Clinic Based Screening|"The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests~Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests"
10778418|NCT02970136|BG002|Baseline|Total|Total of all reporting groups
10778419|NCT02970136|FG000|Participant Flow|Home Based Screening|"The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker~OraQuick Swab: OraQuick for oral fluid HIV antibody testing~Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin~OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick~HPV Self-Sampling Test: Patients will be using swab to check for HPV infection~Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests"
10778420|NCT02970136|FG001|Participant Flow|Clinic Based Screening|"The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests~Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests"
10778421|NCT02970136|OG000|Outcome|Home Based Screening|"The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker~OraQuick Swab: OraQuick for oral fluid HIV antibody testing~Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin~OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick~HPV Self-Sampling Test: Patients will be using swab to check for HPV infection~Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests"
10778422|NCT02970136|OG001|Outcome|Clinic Based Screening|"The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests~Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests"
10778423|NCT02970136|EG000|Reported Event|Home Based Screening|"The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker~OraQuick Swab: OraQuick for oral fluid HIV antibody testing~Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin~OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick~HPV Self-Sampling Test: Patients will be using swab to check for HPV infection~Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests"
10850547|NCT00303446|BG001|Baseline|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
10850548|NCT00303446|BG002|Baseline|Total|Total of all reporting groups
10850549|NCT00303446|FG000|Participant Flow|Placebo|Matched placebo, one tablet daily
10778424|NCT02970136|EG001|Reported Event|Clinic Based Screening|"The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests~Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests"
10778425|NCT02969928|BG000|Baseline|Amoxicillin and Metronidazole|"In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.~Metronidazole: Administration of Metronidazole 400mg tid for 7 days."
10778426|NCT02969928|BG001|Baseline|Clarithromycin|"In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days"
10778427|NCT02969928|BG002|Baseline|Total|Total of all reporting groups
10778428|NCT02969928|FG000|Participant Flow|Amoxicillin and Metronidazole|"In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.~Metronidazole: Administration of Metronidazole 400mg tid for 7 days."
10778429|NCT02969928|FG001|Participant Flow|Clarithromycin|"In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days"
10778430|NCT02969928|OG000|Outcome|Amoxicillin and Metronidazole|"In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.~Metronidazole: Administration of Metronidazole 400mg tid for 7 days."
10778431|NCT02969928|OG001|Outcome|Clarithromycin|"In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days"
10778432|NCT02969928|EG000|Reported Event|Amoxicillin and Metronidazole|"In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.~Metronidazole: Administration of Metronidazole 400mg tid for 7 days."
10778433|NCT02969928|EG001|Reported Event|Clarithromycin|"In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.~Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites~Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days"
10778434|NCT02949297|BG000|Baseline|Ovation Alto Abdominal Stent Graft System|"Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.~Ovation Alto Abdominal Stent Graft System: Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System"
10778435|NCT02949297|FG000|Participant Flow|Ovation Alto Abdominal Stent Graft System|"Endovascular repair of abdominal aortic aneurysm (AAA) using the Ovation Alto Abdominal Stent Graft System.~Ovation Alto Abdominal Stent Graft System: Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System"
10778436|NCT02949297|OG000|Outcome|Ovation Alto Abdominal Stent Graft System|"Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.~Ovation Alto Abdominal Stent Graft System: Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System"
10778437|NCT02949297|EG000|Reported Event|Ovation Alto Abdominal Stent Graft System|"Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.~Ovation Alto Abdominal Stent Graft System: Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System"
10778438|NCT02945787|BG000|Baseline|Extended Self-help|"Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.~Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months."
10778439|NCT02945787|BG001|Baseline|Usual Care (UC)|"NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.~NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months."
10778440|NCT02945787|BG002|Baseline|Total|Total of all reporting groups
10801050|NCT02833844|FG000|Participant Flow|Double-Blind Placebo/Open-Label Evolocumab|Double-blind placebo subcutaneous (SC) injection every 4 weeks (QM) for 24 weeks in the double-blind period, followed by open-label evolocumab 420 mg SC QM for 24 weeks in the open-label period.
10850550|NCT00303446|FG001|Participant Flow|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
10850551|NCT00303446|OG000|Outcome|Placebo|Matched placebo, one tablet daily
10850552|NCT00303446|OG001|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
10850553|NCT00303446|EG000|Reported Event|Placebo|Matched placebo, one tablet daily
10850554|NCT00303446|EG001|Reported Event|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
10850555|NCT00303459|BG000|Baseline|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
10778441|NCT02945787|FG000|Participant Flow|Extended Self-help|"Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.~Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months."
10778442|NCT02945787|FG001|Participant Flow|Usual Care (UC)|"NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.~NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months."
10778443|NCT02945787|OG000|Outcome|Extended Self-help|"Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.~Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months."
10778444|NCT02945787|OG001|Outcome|Usual Care (UC)|"NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.~NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months."
10778445|NCT02945787|EG000|Reported Event|Extended Self-help|"Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.~Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months."
10778446|NCT02945787|EG001|Reported Event|Usual Care (UC)|"NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.~NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months."
10778447|NCT02857426|BG000|Baseline|PCNSL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778448|NCT02857426|BG001|Baseline|PTL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778449|NCT02857426|BG002|Baseline|Total|Total of all reporting groups
11240921|NCT02482805|OG001|Outcome|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778450|NCT02857426|FG000|Participant Flow|PCNSL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778451|NCT02857426|FG001|Participant Flow|PTL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
11240922|NCT02482805|OG002|Outcome|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778452|NCT02857426|OG000|Outcome|PCNSL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778453|NCT02857426|OG001|Outcome|PTL Cohort|"Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778454|NCT02857426|EG000|Reported Event|PCNSL Cohort Nivolumab 240 mg (Q2W)|"Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10778455|NCT02857426|EG001|Reported Event|PTL Cohort Nivolumab 240 mg (Q2W)|"Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).~Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion."
10801051|NCT02833844|FG001|Participant Flow|Double-Blind Evolocumab/Open-Label Evolocumab|Double-blind evolocumab SC injection QM for 24 weeks in the double-blind period, followed by open-label evolocumab 420 mg SC QM for 24 weeks in the open-label period.
10778456|NCT02855125|BG000|Baseline|TAS-114 + S-1|Participants received 400 mg of TAS-114 tablets orally BID along with 30 mg/m^2 of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).
10778457|NCT02855125|BG001|Baseline|S-1 (Monotherapy)|Participants received 30 mg/m^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).
10778458|NCT02855125|BG002|Baseline|Total|Total of all reporting groups
10778459|NCT02855125|FG000|Participant Flow|TAS-114 + S-1|Participants received 400 milligrams (mg) of TAS-114 tablets orally twice daily (BID) along with 30 milligrams per meter square (mg/m^2) of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).
10778460|NCT02855125|FG001|Participant Flow|S-1 (Monotherapy)|Participants received 30 mg/m^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).
10778461|NCT02855125|OG000|Outcome|TAS-114 + S-1|Participants received 400 mg of TAS-114 tablets orally BID along with 30 mg/m^2 of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).
10778462|NCT02855125|OG001|Outcome|S-1 (Monotherapy)|Participants received 30 mg/m^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).
10778463|NCT02855125|EG000|Reported Event|TAS-114 + S-1|Participants received 400 mg of TAS-114 tablets orally BID along with 30 mg/m^2 of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).
10778464|NCT02855125|EG001|Reported Event|S-1 (Monotherapy)|Participants received 30 mg/m^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).
10778465|NCT02836236|BG000|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
10778466|NCT02836236|BG001|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
10778467|NCT02836236|BG002|Baseline|Total|Total of all reporting groups
10778468|NCT02836236|FG000|Participant Flow|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
10778469|NCT02836236|FG001|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
10778470|NCT02836236|OG000|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 144 weeks
10778471|NCT02836236|OG001|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
10778472|NCT02836236|EG000|Reported Event|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
10778473|NCT02836236|EG001|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
10778474|NCT02728752|BG000|Baseline|Placebo|Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778475|NCT02728752|BG001|Baseline|Octagam10%|Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778476|NCT02728752|BG002|Baseline|Total|Total of all reporting groups
10801052|NCT02833844|OG000|Outcome|Double-Blind Placebo|Double-blind placebo SC injection QM for 24 weeks.
10801053|NCT02833844|OG001|Outcome|Double-Blind Evolocumab|Double-blind evolocumab SC injection QM for 24 weeks.
10801054|NCT02833844|EG000|Reported Event|Double-Blind Placebo|Double-blind placebo SC injection QM for 24 weeks.
10801055|NCT02833844|EG001|Reported Event|Double-Blind Evolocumab|Double-blind evolocumab SC injection QM for 24 weeks.
10801056|NCT02833844|EG002|Reported Event|Double-Blind Placebo/Open-Label Evolocumab|Participants originally randomized to placebo in the double-blind period then received open-label evolocumab 420 mg SC QM for 24 weeks.
10850556|NCT00303459|BG001|Baseline|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
10778477|NCT02728752|FG000|Participant Flow|Placebo|Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778478|NCT02728752|FG001|Participant Flow|Octagam10%|Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778479|NCT02728752|OG000|Outcome|Placebo|Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778480|NCT02728752|OG001|Outcome|Octagam10%|Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778481|NCT02728752|OG001|Outcome|Octagam10%|"Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.~Octagam 10%: Patients to be treated with Octagam 10%"
10778482|NCT02728752|EG000|Reported Event|First Period Placebo|Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but with not further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778483|NCT02728752|EG001|Reported Event|Overall Period Octagam|Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
10778484|NCT02680587|BG000|Baseline|Observational (no SBRT)|"Evaluating males with oligometastatic prostate cancer lesions randomized to observation~Observational (no SBRT): These patients will not receive SBRT. They will be observed."
10778485|NCT02680587|BG001|Baseline|SBRT|"Evaluating males with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778486|NCT02680587|BG002|Baseline|Total|Total of all reporting groups
10778487|NCT02680587|FG000|Participant Flow|Observational (no SBRT)|"Evaluating men with oligometastatic prostate cancer lesions randomized to observation~Observational (no SBRT): These patient will not receive SBRT. They will be observed."
10850557|NCT00303459|BG002|Baseline|Total|Total of all reporting groups
10778488|NCT02680587|FG001|Participant Flow|SBRT|"Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778489|NCT02680587|OG000|Outcome|Observational (no SBRT)|"Evaluating men with oligometastatic prostate cancer lesions randomized to observation~Observational (no SBRT): These patient will not receive SBRT. They will be observed."
10778490|NCT02680587|OG001|Outcome|SBRT|"Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778491|NCT02680587|OG000|Outcome|SBRT|"Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778492|NCT02680587|OG001|Outcome|Observational (no SBRT)|"Evaluating men with oligometastatic prostate cancer lesions randomized to observation~Observational (no SBRT): These patient will not receive SBRT. They will be observed."
10778493|NCT02680587|OG000|Outcome|Observational (no SBRT)|Men with oligometastatic prostate cancer lesions randomized to observation
10778494|NCT02680587|OG001|Outcome|SBRT|"Men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778495|NCT02680587|EG000|Reported Event|Observational (no SBRT)|"Evaluating men with oligometastatic prostate cancer lesions randomized to observation~Observational (no SBRT): These patient will not receive SBRT. They will be observed."
10778496|NCT02680587|EG001|Reported Event|SBRT|"Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).~SBRT: SBRT (1-5 fractions) will be administered."
10778497|NCT02667639|BG000|Baseline|Treatment|"A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.~RPH-104"
10778498|NCT02667639|BG001|Baseline|Placebo|"A single 0.9% sodium chloride injection is administered subcutaneously.~Sodium chloride Sterile Injection 0.9% w/v"
10778499|NCT02667639|BG002|Baseline|Total|Total of all reporting groups
10778500|NCT02667639|FG000|Participant Flow|Treatment|"A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.~RPH-104"
10778501|NCT02667639|FG001|Participant Flow|Placebo|"A single 0.9% sodium chloride injection is administered subcutaneously.~Sodium chloride Sterile Injection 0.9% w/v"
10778502|NCT02667639|OG000|Outcome|Treatment|"A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.~RPH-104"
10778503|NCT02667639|OG001|Outcome|Placebo|"A single 0.9% sodium chloride injection is administered subcutaneously.~Sodium chloride Sterile Injection 0.9% w/v"
10778504|NCT02667639|OG000|Outcome|Treatment|"A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.~RPH-104: Anti-IL-1 Mab"
10778505|NCT02667639|OG001|Outcome|Placebo|"A single 0.9% sodium chloride injection will be administered subcutaneously.~Sodium chloride Sterile Injection 0.9% w/v: Sterile saline solution"
10778506|NCT02667639|EG000|Reported Event|Treatment|"A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.~RPH-104"
10778507|NCT02667639|EG001|Reported Event|Placebo|"A single 0.9% sodium chloride injection is administered subcutaneously.~Sodium chloride Sterile Injection 0.9% w/v"
11193274|NCT02144233|FG001|Participant Flow|Placebo Occlusal Adjustment Therapy|"Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.~Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed."
11240923|NCT02482805|EG000|Reported Event|Power Posing|"Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10801057|NCT02833844|EG003|Reported Event|Double-Blind Evolocumab/Open-Label Evolocumab|Participants originally randomized to evolocumab in the double-blind period then received open-label evolocumab 420 mg SC QM for 24 weeks.
10801058|NCT02779855|BG000|Baseline|Phase 1 Dose Level 1|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801059|NCT02779855|BG001|Baseline|Phase 1 Dose Level 2|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 for remaining injections.~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801060|NCT02779855|BG002|Baseline|Phase 2|"Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).~Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801061|NCT02779855|BG003|Baseline|Total|Total of all reporting groups
10801062|NCT02779855|FG000|Participant Flow|Talimogene Laherparepvec + Chemotherapy -Phase 1 Dose Level 1|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801063|NCT02779855|FG001|Participant Flow|Talimogene Laherparepvec + Chemotherapy -Phase 1 Dose Level 2|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 for remaining injections~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801064|NCT02779855|FG002|Participant Flow|Talimogene Laherparepvec + Chemotherapy -Phase 2|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase 2 at MTD~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10850558|NCT00303459|FG000|Participant Flow|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d."
10850559|NCT00303459|FG001|Participant Flow|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
10964400|NCT00877058|FG001|Participant Flow|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
10964401|NCT00877058|FG002|Participant Flow|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
10964402|NCT00877058|OG000|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
10964403|NCT00877058|OG001|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
10964404|NCT00877058|OG002|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
10778517|NCT02527798|BG000|Baseline|Furosemide Cohort 1|"Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.~Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778518|NCT02527798|BG001|Baseline|Placebo Cohort 1|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778519|NCT02527798|BG002|Baseline|Furosemide Cohort 2|"Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778520|NCT02527798|BG003|Baseline|Placebo Cohort 2|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778521|NCT02527798|BG004|Baseline|Furosemide Cohort 3|"Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778522|NCT02527798|BG005|Baseline|Placebo Cohort 3|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778523|NCT02527798|BG006|Baseline|Total|Total of all reporting groups
10778524|NCT02527798|FG000|Participant Flow|Furosemide Cohort 1|"Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.~Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review."
10964405|NCT00877058|EG000|Reported Event|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
10966594|NCT00887653|BG000|Baseline|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
10778525|NCT02527798|FG001|Participant Flow|Placebo Cohort 1|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778526|NCT02527798|FG002|Participant Flow|Furosemide Cohort 2|"Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778527|NCT02527798|FG003|Participant Flow|Placebo Cohort 2|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778528|NCT02527798|FG004|Participant Flow|Furosemide Cohort 3|"Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778529|NCT02527798|FG005|Participant Flow|Placebo Cohort 3|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778530|NCT02527798|OG000|Outcome|Furosemide Cohort 1|"Within cohort 1, infants were randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive 1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.~Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778531|NCT02527798|OG001|Outcome|Placebo Cohort 1|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778532|NCT02527798|OG002|Outcome|Furosemide Cohort 2|"Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778533|NCT02527798|OG003|Outcome|Placebo Cohort 2|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778534|NCT02527798|OG004|Outcome|Furosemide Cohort 3|"Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778535|NCT02527798|OG005|Outcome|Placebo Cohort 3|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778536|NCT02527798|OG006|Outcome|Total|Sum of all groups
10778537|NCT02527798|OG000|Outcome|Furosemide Cohort 1|"Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.~Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778538|NCT02527798|OG006|Outcome|Weekly Total|Weekly total (Cohort 1 Furosemide/Placebo and Cohort 2 Furosemide/Placebo
10778539|NCT02527798|OG001|Outcome|Furosemide Cohort 2|"Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
11240924|NCT02482805|EG001|Reported Event|Submissive Posing|"Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778540|NCT02527798|OG002|Outcome|Placebo Cohort 1|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
11240925|NCT02482805|EG002|Reported Event|Rest|"Individuals rest (no postures) for 2 minutes prior to exposure therapy.~Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder"
10778541|NCT02527798|OG000|Outcome|Furosemide Cohort 1|PK Population: Furosemide/Active drug arms from Cohort 1
10778542|NCT02527798|OG001|Outcome|Furosemide Cohort 2|PK Population: Furosemide/Active drug arms from Cohort 2
10778543|NCT02527798|OG002|Outcome|Furosemide (Cohort 1 and Cohort 2)|PK Population: Furosemide/Active drug arms from Cohort 1 and Cohort 2
10778544|NCT02527798|OG002|Outcome|Furosemide All (Cohort 1 and Cohort 2)|PK Population: Furosemide/Active drug arms from Cohort 1 and Cohort 2
10778545|NCT02527798|OG000|Outcome|Furosemide Cohort 1|PK Population: Furosemide/Active drug from Cohort 1
10778546|NCT02527798|OG001|Outcome|Furosemide Cohort 2|PK Population: Furosemide/Active drug from Cohort 2
10778547|NCT02527798|OG002|Outcome|Furosemide Cohort 1 and Cohort 2|PK Population: Combined Furosemide/Active drug from Cohort 1 and Cohort 2
10778548|NCT02527798|OG002|Outcome|Furosemide (Cohort 1 and Cohort 2)|PK Population: Furosemide/Active drug from Cohort 1 and Cohort 2
10778549|NCT02527798|EG000|Reported Event|Furosemide Cohort 1|"Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.~Furosemide Cohort 1: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778550|NCT02527798|EG001|Reported Event|Placebo Cohort 1|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10850560|NCT00303459|OG000|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
10778551|NCT02527798|EG002|Reported Event|Furosemide Cohort 2|"Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 2: furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778552|NCT02527798|EG003|Reported Event|Placebo Cohort 2|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778553|NCT02527798|EG004|Reported Event|Furosemide Cohort 3|"Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.~Furosemide Cohort 3: furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review."
10778554|NCT02527798|EG005|Reported Event|Placebo Cohort 3|"Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).~Placebo: Sugar water will be administered in a equivalent volume as drug intervention."
10778555|NCT02416492|BG000|Baseline|Treatment Group: 2.5 Million Cells|"2.5 million SB623 cells~SB623 surgically implanted"
10778556|NCT02416492|BG001|Baseline|Treatment Group: 5 Million Cells|"5 million SB623 cells~SB623 surgically implanted"
10778557|NCT02416492|BG002|Baseline|Treatment Group: 10 Million Cells|"10 million SB623 cells~SB623 surgically implanted"
10778558|NCT02416492|BG003|Baseline|Sham Surgery|"Control Sham Surgery~Sham Control: Sham Surgery"
10778559|NCT02416492|BG004|Baseline|Total|Total of all reporting groups
10778560|NCT02416492|FG000|Participant Flow|Treatment Group: SB623 2.5 Million Cells|"2.5 million SB623 cells~SB623 surgically implanted"
10778561|NCT02416492|FG001|Participant Flow|Treatment Group: SB623 5 Million Cells|"5 million SB623 cells~SB623 surgically implanted"
10778562|NCT02416492|FG002|Participant Flow|Treatment Group: SB623 10 Million Cells|"10 million SB623 cells~SB623 surgically implanted"
10778563|NCT02416492|FG003|Participant Flow|Treatment Group: Sham Surgery|"Control Sham Surgery~Sham Control: Sham Surgery"
10778564|NCT02416492|OG000|Outcome|Treatment Group: 2.5 Million Cells|"2.5 million SB623 cells~SB623 surgically implanted"
10778565|NCT02416492|OG001|Outcome|Treatment Group: 5 Million Cells|"5 million SB623 cells~SB623 surgically implanted"
10778566|NCT02416492|OG002|Outcome|Treatment Group: 10 Million Cells|"10 million SB623 cells~SB623 surgically implanted"
10778567|NCT02416492|OG003|Outcome|Sham Surgery|"Control Sham Surgery~Sham Control: Sham Surgery"
10778568|NCT02416492|OG000|Outcome|Treatment Group: SB623 2.5 Million Cells|"2.5 million SB623 cells~SB623 surgically implanted"
10778569|NCT02416492|OG001|Outcome|Treatment Group: SB623 5 Million Cells|"5 million SB623 cells~SB623 surgically implanted"
10778570|NCT02416492|OG002|Outcome|Treatment Group: SB623 10 Million Cells|"10 million SB623 cells~SB623 surgically implanted"
10778571|NCT02416492|EG000|Reported Event|Treatment Group: SB623 2.5 Million Cells|"2.5 million SB623 cells~SB623 surgically implanted"
10778572|NCT02416492|EG001|Reported Event|Treatment Group: SB623 5 Million Cells|"5 million SB623 cells~SB623 surgically implanted"
10778573|NCT02416492|EG002|Reported Event|Treatment Group: SB623 10 Million Cells|"10 million SB623 cells~SB623 surgically implanted"
10778574|NCT02416492|EG003|Reported Event|Sham Surgery|"Control Sham Surgery~Sham Control: Sham Surgery"
10778575|NCT02324816|BG000|Baseline|Lateral Thigh Treatment Group|Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
11193275|NCT02144233|OG000|Outcome|Occlusal Adjustmen Therapy|"Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.~Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure.~The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)"
11193276|NCT02144233|OG001|Outcome|Placebo Occlusal Adjustment Therapy|"Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.~Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed."
11202201|NCT02205983|EG002|Reported Event|1000 mg Acetaminophen|"Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.~1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task."
11202202|NCT02205983|EG003|Reported Event|Dextrose|"Healthy adult volunteers will recieve Dextrose (placebo).~dextrose: We are administering dextrose to healthy volunteers for our placebo group."
11240926|NCT02482870|BG000|Baseline|All Study Participants|Each patient were intubated with both Macintosh and King Vision video laryngoscope sequentially. The order of the laryngoscopes was randomized by flipping a coin.
10778576|NCT02324816|FG000|Participant Flow|Lateral Thigh Treatment Group|"Non-invasive subcutaneous fat reduction in the lateral thighs treatment group~The Zeltiq CoolSculpting System: CoolSculpting treatment."
10778577|NCT02324816|OG000|Outcome|Lateral Thigh Treatment Group|Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
10778578|NCT02324816|EG000|Reported Event|Lateral Thigh Treatment Group|Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
10850561|NCT00303459|OG001|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
10778579|NCT02279745|BG000|Baseline|Oral Ralinepag|"Ralinepag IR capsules of 10, 20, 30, 40, and 100 mcg or XR tablets of 50, 250, and 400 mcg for oral administration were provided. The starting dose and titration schedule were determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003. Subjects in the placebo treatment group in Study APD811-003 underwent a dose titration period (up to 9 weeks) with ralinepag until a stable MTD was reached.~Ralinepag: Active"
10778580|NCT02279745|FG000|Participant Flow|Oral Ralinepag|"Ralinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration were provided. The starting dose and titration schedule were determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003. Subjects in the placebo treatment group in Study APD811-003 underwent a dose titration period (up to 9 weeks) with ralinepag until a stable maximum tolerated dose (MTD) was reached.~Ralinepag: Active"
10778581|NCT02279745|OG000|Outcome|Oral Ralinepag|"Ralinepag IR capsules of 10, 20, 30, 40, and 100 mcg or XR tablets of 50, 250, and 400 mcg for oral administration were provided. The starting dose and titration schedule were determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003. Subjects in the placebo treatment group in Study APD811-003 underwent a dose titration period (up to 9 weeks) with ralinepag until a stable MTD was reached.~Ralinepag: Active"
10778582|NCT02279745|EG000|Reported Event|Oral Ralinepag|"Ralinepag IR capsules of 10, 20, 30, 40, and 100 mcg or XR tablets of 50, 250, and 400 mcg for oral administration were provided. The starting dose and titration schedule were determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003. Subjects in the placebo treatment group in Study APD811-003 underwent a dose titration period (up to 9 weeks) with ralinepag until a stable MTD was reached.~Ralinepag: Active~There was only 1 active dose group in this open-label study (oral ralinepag). Subjects included in this study received ralinepag and completed previous Study APD811-003, or received placebo and discontinued Study APD811-003 due to clinical worsening. All subjects enrolled in Study APD811-007 received open-label treatment with oral ralinepag IR or XR formulations. The starting dose and titration schedule were individually determined in accordance with the starting dose and titration schedule optimized during Study APD811 003. Adjustments in the dose and titration schedule were made according to subject tolerability."
10778583|NCT02067975|BG000|Baseline|Healthy Controls|All participants will receive both 6gm of tryptophan at least two weeks apart at time zero of 7 hour visits 2 and 3, and will also receive Placebo will be a liquid drink without tryptophan. 6mg at least two weeks apart at time zero of the 7 hour visits 2 and 3. The order in which participants receive either placebo or tryptophan will be randomized (ie. placebo first study visit day tryptophan on second study day, or tryptophan on first study day and placebo on second study day). Note that some of the participants included only participated in the screening and did not participate in the challenge phase of the study.
10778584|NCT02067975|BG001|Baseline|Schizophrenia Related Disorders|All participants will receive both 6gm of tryptophan at least two weeks apart at time zero of 7 hour visits 2 and 3, and will also receive Placebo will be a liquid drink without tryptophan. 6mg at least two weeks apart at time zero of the 7 hour visits 2 and 3. The order in which participants receive either placebo or tryptophan will be randomized (ie. placebo first study visit day tryptophan on second study day, or tryptophan on first study day and placebo on second study day). Note that some of the participants included only participated in the screening and did not participate in the challenge phase of the study.
10778585|NCT02067975|BG002|Baseline|Total|Total of all reporting groups
10778586|NCT02067975|FG000|Participant Flow|Schizophrenia Related Disorders: Tryptophan First, Then Placebo|All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform.
10778587|NCT02067975|FG001|Participant Flow|Healthy Control: Tryptophan First, Then Placebo|All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants had no psychiatric conditions.
10778588|NCT02067975|FG002|Participant Flow|Schizophrenia Related Disorders: Placebo First, Then Tryptophan|All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform.
10778589|NCT02067975|FG003|Participant Flow|Healthy Control: Placebo First, Then Tryptophan|All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants had no psychiatric conditions.
10778590|NCT02067975|FG004|Participant Flow|Schizophrenia Related Disorders: Screening Only/Not Randomized|All participants had not yet completed the screening phase or been randomized. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform.
10778591|NCT02067975|FG005|Participant Flow|Healthy Control: Screening Only/Not Randomized|All participants had not yet completed the screening phase or been randomized. These participants had no psychiatric conditions.
10778592|NCT02067975|OG000|Outcome|Healthy Controls: Placebo|All participants received 6gm of placebo dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
10778593|NCT02067975|OG001|Outcome|Schizophrenia Related Disorders: Placebo|All participants received 6gm of placebo dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
11240927|NCT02482870|FG000|Participant Flow|Macintosh First, Then King Vision|The patients has been intubated first with a Macintosh, then with a King Vision video laryngoscope.
10778594|NCT02067975|OG002|Outcome|Healthy Controls: Tryptophan|All participants received 6gm of tryptophan dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
10778595|NCT02067975|OG003|Outcome|Schizophrenia Related Disorders: Tryptophan|All participants received 6gm of tryptophan dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
10778596|NCT02067975|EG000|Reported Event|Healthy Control: Tryptophan|All participants received 6gm of tryptophan dissolved in water.
10778597|NCT02067975|EG001|Reported Event|Schizophrenia Related Disorders: Tryptophan|All participants received 6gm of tryptophan dissolved in water.
10778598|NCT02067975|EG002|Reported Event|Healthy Controls: Placebo|All participants received 6gm of placebo dissolved in water.
10778599|NCT02067975|EG003|Reported Event|Schizophrenia Related Disorders: Placebo|All participants received 6gm of placebo dissolved in water.
10778600|NCT02067975|EG004|Reported Event|Healthy Controls: Screening|All participants had not yet completed the screening phase or been randomized.
10778601|NCT02067975|EG005|Reported Event|Schizophrenia Related Disorders: Screening|All participants had not yet completed the screening phase or been randomized.
10778602|NCT02030938|BG000|Baseline|SERI® Surgical Scaffold Implanted Breasts|SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
10778603|NCT02030938|FG000|Participant Flow|SERI® Surgical Scaffold Implanted Breasts|SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
10778604|NCT02030938|OG000|Outcome|Skin Stretch|Subjects who presented with Skin stretch as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
10778605|NCT02030938|OG001|Outcome|Fold Malposition|Subjects who presented with Fold Malposition as the initial cause of the increase in N:IMF distance (presenting condition for procedure)
10778606|NCT02030938|OG000|Outcome|SERI® Surgical Scaffold Implanted Breasts|SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
10778607|NCT02030938|OG000|Outcome|SN:N|Sternal Notch to Nipple distance in cm
10778608|NCT02030938|OG001|Outcome|N:IMF|Nipple to Inframammary Fold Distance at rest in cm
10778609|NCT02030938|EG000|Reported Event|SERI® Surgical Scaffold Implanted Breasts|SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
10778610|NCT02006147|BG000|Baseline|TLC399 (Group 1)|0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778611|NCT02006147|BG001|Baseline|TLC399 (Group R1)|0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778612|NCT02006147|BG002|Baseline|TLC399 (Group 2)|0.6 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778613|NCT02006147|BG003|Baseline|TLC399 (Group 3)|0.6 mg Dexamethasone Sodium Phosphate with 50 mM Phospholipid
10778614|NCT02006147|BG004|Baseline|Total|Total of all reporting groups
10778615|NCT02006147|FG000|Participant Flow|TLC399 (Group 1)|0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778616|NCT02006147|FG001|Participant Flow|TLC399 (Group R1)|0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778617|NCT02006147|FG002|Participant Flow|TLC399 (Group 2)|0.6 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778618|NCT02006147|FG003|Participant Flow|TLC399 (Group 3)|0.6 mg Dexamethasone Sodium Phosphate with 50 mM Phospholipid
10778619|NCT02006147|OG000|Outcome|TLC399 (Group 1)|0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778620|NCT02006147|OG001|Outcome|TLC399 (Group R1)|0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778621|NCT02006147|EG000|Reported Event|TLC399 (Group 1)|0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778622|NCT02006147|EG001|Reported Event|TLC399 (Group R1)|0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
10778623|NCT01940341|BG000|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778624|NCT01940341|BG001|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778625|NCT01940341|BG002|Baseline|Total|Total of all reporting groups
10778626|NCT01940341|FG000|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778627|NCT01940341|FG001|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778628|NCT01940341|OG000|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778629|NCT01940341|OG001|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778630|NCT01940341|OG000|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778631|NCT01940341|OG001|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778632|NCT01940341|EG000|Reported Event|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778633|NCT01940341|EG001|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
10778634|NCT01925794|BG000|Baseline|COBRA PzF Stent|COBRA PzF Coronary Stent System
10778635|NCT01925794|FG000|Participant Flow|COBRA PzF Stent|COBRA PzF Coronary Stent System
10778636|NCT01925794|OG000|Outcome|COBRA PzF Stent|COBRA PzF Coronary Stent System
10778637|NCT01925794|OG000|Outcome|COBRA PzF Stent|COBRA PzF Coronary Stent
10778638|NCT01925794|OG000|Outcome|Angiographic Cohort|A group of patients who underwent angiographic assessment after the clinical assessment at 270 days.
10778639|NCT01925794|OG000|Outcome|Angiographic Cohort|A group of patients who underwent an angiographic assessment after the clinical assessment at 270 days
10778640|NCT01925794|OG000|Outcome|OCT Cohort|A group of those patients who underwent OCT assessment after the clinical follow up at 270 days
10778641|NCT01925794|EG000|Reported Event|COBRA PzF Stent|COBRA PzF Coronary Stent System
10801065|NCT02779855|OG000|Outcome|Talimogene Laherparepvec + Chemotherapy|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD.~Talimogene laherparepvec: Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801066|NCT02779855|OG000|Outcome|Phase 1 Dose Level 1|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801067|NCT02779855|OG001|Outcome|Phase 1 Dose Level 2|"Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 PFU for remaining injections.~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801068|NCT02779855|OG002|Outcome|Phase 2|"Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).~Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801069|NCT02779855|EG000|Reported Event|Phase 1 Dose Level 1|".Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801070|NCT02779855|EG001|Reported Event|Phase 1 Dose Level 2|".Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 PFU for remaining injections.~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801071|NCT02779855|EG002|Reported Event|Phase 2|"Phase II: Treatment at Maximum Tolerated Dose (MTD) . The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).~Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD~Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2."
10801072|NCT02663271|BG000|Baseline|Optune+Pulsed Bevacizumab|"The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.~Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.~Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.~Brain MRI: Brain MRI will be done at screening and every 8 weeks.~Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks."
10801073|NCT02663271|FG000|Participant Flow|Optune+Pulsed Bevacizumab|"The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.~Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.~Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.~Brain MRI: Brain MRI will be done at screening and every 8 weeks.~Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks."
10850562|NCT00303459|OG000|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
10850563|NCT00303459|EG000|Reported Event|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
10850564|NCT00303459|EG001|Reported Event|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
11240928|NCT02482870|FG001|Participant Flow|King Vision First, Then Macintosh|The patients has been intubated first with a King Vision video laryngoscope, then with a Macintosh laryngoscope.
11240929|NCT02482870|OG000|Outcome|Macintosh|Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.
11240930|NCT02482870|OG001|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
11240931|NCT02482870|OG000|Outcome|Macintosh|Using a Macintosh laryngoscope, intubation time has been recorded.
11240932|NCT02482870|OG001|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, intubation time has been recorded.
10778642|NCT01907360|BG000|Baseline|HLD200 (Methylphenidate Hydrochloride) in Adolescents|HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to adolescents aged 13-17 years.
10778643|NCT01907360|BG001|Baseline|HLD200 (Methylphenidate Hydrochloride) in Children|HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years.
10778644|NCT01907360|BG002|Baseline|Total|Total of all reporting groups
10778645|NCT01907360|FG000|Participant Flow|Adolescents (13-17yrs)|"Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)~B-HLD200 54mg capsules~C-HLD200 54mg capsules"
10778646|NCT01907360|FG001|Participant Flow|Children (6-12 Yrs)|"Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)~B-HLD200 54mg capsules~C-HLD200 54mg capsules"
10778647|NCT01907360|OG000|Outcome|HLD200 in Adolescents (13-17 Years)|Drug: HLD200 (methylphenidate hydrochloride; 54 mg) capsules
10778648|NCT01907360|OG001|Outcome|HLD200 in Children (6-12 Yrs)|Drug: HLD200 (methylphenidate hydrochloride; 54mg) capsules
10778649|NCT01907360|EG000|Reported Event|Adolescents (13-17yrs)|Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)
10778650|NCT01907360|EG001|Reported Event|Children (6-12 Yrs)|Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)
10778651|NCT01856868|BG000|Baseline|Treatment With Epicatechin|"Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.~(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks."
10778652|NCT01856868|FG000|Participant Flow|Treatment With Epicatechin|"Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.~(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks."
10778653|NCT01856868|OG000|Outcome|Treatment With Epicatechin|"Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.~(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks."
10778654|NCT01856868|EG000|Reported Event|Treatment With Epicatechin|"Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.~(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks."
10778655|NCT01849250|BG000|Baseline|Placebo|Placebo orally twice a day for 12 weeks.
10778656|NCT01849250|BG001|Baseline|Docosahexaenoic Acid|DHA 1000 mg orally twice a day for 12 weeks.
10778657|NCT01849250|BG002|Baseline|Total|Total of all reporting groups
10778658|NCT01849250|FG000|Participant Flow|Placebo|Placebo orally twice a day for 12 weeks.
10778659|NCT01849250|FG001|Participant Flow|Docosahexaenoic Acid (DHA)|Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.
10778660|NCT01849250|OG000|Outcome|Placebo|Placebo orally twice a day for 12 weeks.
10778661|NCT01849250|OG001|Outcome|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.
10778662|NCT01849250|OG001|Outcome|Docosahexaenoic Acid (DHA)|Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.
10778663|NCT01849250|EG000|Reported Event|Placebo|Placebo orally twice a day for 12 weeks.
10778664|NCT01849250|EG001|Reported Event|Docosahexaenoic Acid|Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.
10778665|NCT01592643|BG000|Baseline|Eye Shield|Participants receive eye shield during PRK surgery
10778666|NCT01592643|FG000|Participant Flow|Eye Shield|"Participants receive eye shield during PRK surgery~Eye Shield: The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye."
10778667|NCT01592643|OG000|Outcome|Eye Shield|Participants receive eye shield during PRK surgery
10778668|NCT01592643|EG000|Reported Event|Eye Shield|Participants receive eye shield during PRK surgery
10778669|NCT01441115|BG000|Baseline|ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778670|NCT01441115|FG000|Participant Flow|ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778671|NCT01441115|OG000|Outcome|ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778672|NCT01441115|OG000|Outcome|Unrelated|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778673|NCT01441115|OG001|Outcome|Unlikely Related|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778674|NCT01441115|OG002|Outcome|Possibly Related|ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
10778675|NCT01441115|EG000|Reported Event|ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer|"ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer~Radiation Therapy~ECI301"
10778676|NCT01199302|BG000|Baseline|Placebo / Brodalumab 350 mg|Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
10778677|NCT01199302|BG001|Baseline|Brodalumab 210 mg / 350 mg|Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778678|NCT01199302|BG002|Baseline|Brodalumab 350 mg / 350 mg|Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778679|NCT01199302|BG003|Baseline|Brodaluamb 700 mg / 350 mg|Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778680|NCT01199302|BG004|Baseline|Total|Total of all reporting groups
10778681|NCT01199302|FG000|Participant Flow|Placebo / Brodalumab 350 mg|Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
10778682|NCT01199302|FG001|Participant Flow|Brodalumab 210 mg / 350 mg|Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
11240933|NCT02482870|OG000|Outcome|Macintosh|Using a Macintosh laryngoscope, glottic view time has been recorded.
10778683|NCT01199302|FG002|Participant Flow|Brodalumab 350 mg / 350 mg|Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778684|NCT01199302|FG003|Participant Flow|Brodaluamb 700 mg / 350 mg|Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778685|NCT01199302|OG000|Outcome|Placebo / Brodalumab 350 mg|Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
10778686|NCT01199302|OG001|Outcome|Brodalumab 210 mg / 350 mg|Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778687|NCT01199302|OG002|Outcome|Brodalumab 350 mg / 350 mg|Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778688|NCT01199302|OG003|Outcome|Brodaluamb 700 mg / 350 mg|Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778689|NCT01199302|EG000|Reported Event|Brodalumab 350 mg Q4W|Participants received brodalumab 350 mg IV Q4W for up to 132 weeks.
10778690|NCT01123707|BG000|Baseline|Prior Aripiprazole/Escitalopram Combination Therapy|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole/escitalopram combination therapy in the double-blind treatment period in previous studies were included in this group.
10778691|NCT01123707|BG001|Baseline|Prior Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the double-blind treatment period in previous studies were included in this group.
10778692|NCT01123707|BG002|Baseline|Prior Aripiprazole|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole in the double-blind treatment period in previous studies were included in this group.
11193277|NCT02144233|EG000|Reported Event|Occlusal Adjustmen Therapy|"Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.~Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure.~The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)"
10778693|NCT01123707|BG003|Baseline|Prior Single-blind Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the single-blind treatment period in previous studies were included in this group.
10778694|NCT01123707|BG004|Baseline|Total|Total of all reporting groups
10778695|NCT01123707|FG000|Participant Flow|Prior Aripiprazole/Escitalopram Combination Therapy|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the maximum tolerated dose (MTD) by Week 4. Participants who received aripiprazole/escitalopram combination therapy in the double-blind treatment period in previous studies were included in this group.
10778696|NCT01123707|FG001|Participant Flow|Prior Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the double-blind treatment period in previous studies were included in this group.
10778697|NCT01123707|FG002|Participant Flow|Prior Aripiprazole|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole in the double-blind treatment period in previous studies were included in this group.
10850565|NCT00303472|BG000|Baseline|Part A: 300 µg Romiplostim|Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10778698|NCT01123707|FG003|Participant Flow|Prior Single-blind Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the single-blind treatment period in previous studies were included in this group.
10778699|NCT01123707|OG000|Outcome|Prior Aripiprazole/Escitalopram Combination Therapy|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole/escitalopram combination therapy in the double-blind treatment period in previous studies were included in this group.
10778700|NCT01123707|OG001|Outcome|Prior Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the double-blind treatment period in previous studies were included in this group.
10778701|NCT01123707|OG002|Outcome|Prior Aripiprazole|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole in the double-blind treatment period in previous studies were included in this group.
10778702|NCT01123707|OG003|Outcome|Prior Single-blind Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the single-blind treatment period in previous studies were included in this group.
10778703|NCT01123707|EG000|Reported Event|Prior Aripiprazole/Escitalopram Combination Therapy|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole/escitalopram combination therapy in the double-blind treatment period in previous studies were included in this group.
10778704|NCT01123707|EG001|Reported Event|Prior Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the double-blind treatment period in previous studies were included in this group.
10778705|NCT01123707|EG002|Reported Event|Prior Aripiprazole|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received aripiprazole in the double-blind treatment period in previous studies were included in this group.
10778706|NCT01123707|EG003|Reported Event|Prior Single-blind Escitalopram|Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 1 if the initial 6 mg/day dose was tolerated. The dose adjustments were allowed for aripiprazole to establish the MTD by Week 4. Participants who received escitalopram in the single-blind treatment period in previous studies were included in this group.
10778707|NCT00894244|BG000|Baseline|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
10778708|NCT00894244|FG000|Participant Flow|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
10778709|NCT00894244|OG000|Outcome|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
10778710|NCT00894244|EG000|Reported Event|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
10778711|NCT00462943|BG000|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778712|NCT00462943|BG001|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778713|NCT00462943|BG002|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778714|NCT00462943|BG003|Baseline|Total|Total of all reporting groups
10778715|NCT00462943|FG000|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778716|NCT00462943|FG001|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778717|NCT00462943|FG002|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778718|NCT00462943|OG000|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778719|NCT00462943|OG001|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778720|NCT00462943|OG002|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778721|NCT00462943|OG003|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778722|NCT00462943|OG000|Outcome|CML: Chronic Phase|Study participants chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
11193278|NCT02144233|EG001|Reported Event|Placebo Occlusal Adjustment Therapy|"Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.~Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed."
11193279|NCT02144259|BG000|Baseline|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
11193280|NCT02144259|BG001|Baseline|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
10778723|NCT00462943|EG000|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
10778724|NCT00248287|BG000|Baseline|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
10778725|NCT00248287|BG001|Baseline|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
10778726|NCT00248287|BG002|Baseline|Total|Total of all reporting groups
10778727|NCT00248287|FG000|Participant Flow|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
10778728|NCT00248287|FG001|Participant Flow|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
10778729|NCT00248287|OG000|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
10778730|NCT00248287|OG001|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
10778731|NCT00248287|EG000|Reported Event|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
10778732|NCT00248287|EG001|Reported Event|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
10778733|NCT00182728|BG000|Baseline|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
10778734|NCT00182728|FG000|Participant Flow|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
10778735|NCT00182728|OG000|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
10778736|NCT00182728|EG000|Reported Event|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
10778737|NCT00105560|BG000|Baseline|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
10778738|NCT00105560|FG000|Participant Flow|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
10778739|NCT00105560|OG000|Outcome|Radiation Therapy - 3 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
11193281|NCT02144259|BG002|Baseline|Control Group|Subjects selecting their own method of contraception or no contraception.
10778740|NCT00105560|OG001|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
10778741|NCT00105560|OG002|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
10778742|NCT00105560|OG000|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
10778743|NCT00105560|OG001|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
10778744|NCT00105560|OG002|Outcome|Radiation Therapy Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
10778745|NCT00105560|OG002|Outcome|Radiation Therapy - Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
10778746|NCT00105560|OG000|Outcome|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
11193282|NCT02144259|BG003|Baseline|Total|Total of all reporting groups
11193283|NCT02144259|FG000|Participant Flow|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
10778747|NCT00105560|OG000|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
10778748|NCT00105560|OG001|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
10778749|NCT00105560|EG000|Reported Event|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
10778750|NCT00038727|BG000|Baseline|1 Original Lifestyle|"randomized to unmasked Intensive Lifestyle (ILS) during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~DPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778751|NCT00038727|BG001|Baseline|2 Original Metformin|"randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778752|NCT00038727|BG002|Baseline|3 Original Placebo|"randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778753|NCT00038727|BG003|Baseline|Total|Total of all reporting groups
10778754|NCT00038727|FG000|Participant Flow|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
10778755|NCT00038727|FG001|Participant Flow|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
10778756|NCT00038727|FG002|Participant Flow|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
10778757|NCT00038727|OG000|Outcome|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
10778758|NCT00038727|OG001|Outcome|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
10778759|NCT00038727|OG002|Outcome|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
11193284|NCT02144259|FG001|Participant Flow|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
10778760|NCT00038727|OG000|Outcome|1 Original Lifestyle|"randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~DPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778761|NCT00038727|OG001|Outcome|2 Original Metformin|"randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778762|NCT00038727|OG002|Outcome|3 Original Placebo|"randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
10778763|NCT00038727|EG000|Reported Event|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
10778764|NCT00038727|EG001|Reported Event|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
10778765|NCT00038727|EG002|Reported Event|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
10801074|NCT02663271|OG000|Outcome|Optune+Pulsed Bevacizumab|"The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.~Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.~Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.~Brain MRI: Brain MRI will be done at screening and every 8 weeks.~Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks."
10801075|NCT02663271|EG000|Reported Event|Optune+Pulsed Bevacizumab|"The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.~Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.~Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.~Brain MRI: Brain MRI will be done at screening and every 8 weeks.~Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks."
11240934|NCT02482870|OG001|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, glottic view time has been recorded.
10801076|NCT02633267|BG000|Baseline|Usual Vocational Services + CBT|"This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.~Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801077|NCT02633267|BG001|Baseline|Usual Vocational Services|"This is the care as usual intervention - Vocational services as usually delivered to service seeking clients~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801078|NCT02633267|BG002|Baseline|Total|Total of all reporting groups
10801079|NCT02633267|FG000|Participant Flow|Usual Vocational Services + CBT|"This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.~Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801080|NCT02633267|FG001|Participant Flow|Usual Vocational Services|"This is the care as usual intervention - Vocational services as usually delivered to service seeking clients~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10850566|NCT00303472|BG001|Baseline|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10778766|NCT04569786|BG000|Baseline|V590 5.00x10^5 Plaque Forming Units (Pfu)|Participants received a single dose of V590 5.00x10^5 pfu on Day 1.
10778767|NCT04569786|BG001|Baseline|V590 2.40x10^6 Pfu|Participants received a single dose of V590 2.40x10^6 pfu on Day 1.
10778768|NCT04569786|BG002|Baseline|V590 1.15x10^7 Pfu|Participants received a single dose of V590 1.15x10^7 pfu on Day 1.
10778769|NCT04569786|BG003|Baseline|V590 5.55x10^7 Pfu|Participants received a single dose of V590 5.55x10^7 pfu on Day 1.
10778770|NCT04569786|BG004|Baseline|Placebo|Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
10778771|NCT04569786|BG005|Baseline|Total|Total of all reporting groups
10778772|NCT04569786|FG000|Participant Flow|V590 5.00x10^5 Plaque Forming Units (Pfu)|Participants received a single dose of V590 5.00x10^5 pfu on Day 1.
10778773|NCT04569786|FG001|Participant Flow|V590 2.40x10^6 Pfu|Participants received a single dose of V590 2.40x10^6 pfu on Day 1.
10778774|NCT04569786|FG002|Participant Flow|V590 1.15x10^7 Pfu|Participants received a single dose of V590 1.15x10^7 pfu on Day 1.
10778775|NCT04569786|FG003|Participant Flow|V590 5.55x10^7 Pfu|Participants received a single dose of V590 5.55x10^7 pfu on Day 1.
10778776|NCT04569786|FG004|Participant Flow|Placebo|Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
10778777|NCT04569786|OG000|Outcome|V590 5.00x10^5 Plaque Forming Units (Pfu)|Participants received a single dose of V590 5.00x10^5 pfu on Day 1.
10778778|NCT04569786|OG001|Outcome|V590 2.40x10^6 Pfu|Participants received a single dose of V590 2.40x10^6 pfu on Day 1.
10778779|NCT04569786|OG002|Outcome|V590 1.15x10^7 Pfu|Participants received a single dose of V590 1.15x10^7 pfu on Day 1.
10778780|NCT04569786|OG003|Outcome|V590 5.55x10^7 Pfu|Participants received a single dose of V590 5.55x10^7 pfu on Day 1.
10778781|NCT04569786|OG004|Outcome|Placebo|Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
10778782|NCT04569786|EG000|Reported Event|V590 5.00x10^5 Plaque Forming Units (Pfu)|Participants received a single dose of V590 5.00x10^5 pfu on Day 1.
10778783|NCT04569786|EG001|Reported Event|V590 2.40x10^6 Pfu|Participants received a single dose of V590 2.40x10^6 pfu on Day 1.
10778784|NCT04569786|EG002|Reported Event|V590 1.15x10^7 Pfu|Participants received a single dose of V590 1.15x10^7 pfu on Day 1.
10778785|NCT04569786|EG003|Reported Event|V590 5.55x10^7 Pfu|Participants received a single dose of V590 5.55x10^7 pfu on Day 1.
10778786|NCT04569786|EG004|Reported Event|Placebo|Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
10778787|NCT04409041|BG000|Baseline|Treatment Group (Low-dose Naltrexone)|Everyone enrolled received low-dose naltrexone at 3mg oral daily.
10778788|NCT04409041|FG000|Participant Flow|Treatment Group (Low-dose Naltrexone)|Everyone enrolled received low-dose naltrexone at 3mg oral daily.
10778789|NCT04409041|OG000|Outcome|Treatment Group (Low-dose Naltrexone)|Everyone enrolled received low-dose naltrexone at 3mg oral daily.
10778790|NCT04409041|OG000|Outcome|Low-dose Naltrexone Group|"All participants were prescribed low-dose naltrexone at 3mg oral daily.~Low-Dose Naltrexone: Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress."
10778791|NCT04409041|EG000|Reported Event|Treatment Group (Low-dose Naltrexone)|Everyone enrolled received low-dose naltrexone at 3mg oral daily.
10778792|NCT04129944|BG000|Baseline|Placebo|Placebo: Placebo intra-articular injection
10778793|NCT04129944|BG001|Baseline|UBX0101 0.5 mg|UBX0101: Investigational drug intra-articular injection
10778794|NCT04129944|BG002|Baseline|UBX0101 2.0 mg|UBX0101: Investigational drug intra-articular injection
10778795|NCT04129944|BG003|Baseline|UBX0101 4.0 mg|UBX0101: Investigational drug intra-articular injection
10778796|NCT04129944|BG004|Baseline|Total|Total of all reporting groups
10778797|NCT04129944|FG000|Participant Flow|Placebo|Placebo: Placebo intra-articular injection
10778798|NCT04129944|FG001|Participant Flow|UBX0101 0.5 mg|UBX0101: Investigational drug intra-articular injection
10778799|NCT04129944|FG002|Participant Flow|UBX0101 2.0 mg|UBX0101: Investigational drug intra-articular injection
10778800|NCT04129944|FG003|Participant Flow|UBX0101 4.0 mg|UBX0101: Investigational drug intra-articular injection
10778801|NCT04129944|OG000|Outcome|Placebo|Placebo: Placebo intra-articular injection
10778802|NCT04129944|OG001|Outcome|UBX0101 0.5 mg|UBX0101: Investigational drug intra-articular injection
10778803|NCT04129944|OG002|Outcome|UBX0101 2.0 mg|UBX0101: Investigational drug intra-articular injection
10778804|NCT04129944|OG003|Outcome|UBX0101 4.0 mg|UBX0101: Investigational drug intra-articular injection
10778805|NCT04129944|EG000|Reported Event|Placebo|Placebo: Placebo intra-articular injection
10778806|NCT04129944|EG001|Reported Event|UBX0101 0.5 mg|UBX0101: Investigational drug intra-articular injection
10778807|NCT04129944|EG002|Reported Event|UBX0101 2.0 mg|UBX0101: Investigational drug intra-articular injection
10778808|NCT04129944|EG003|Reported Event|UBX0101 4.0 mg|UBX0101: Investigational drug intra-articular injection
10778809|NCT03861728|BG000|Baseline|Viral Conjunctivitis Treatment|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid~0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)"
10778810|NCT03861728|BG001|Baseline|Viral Conjunctivitis Placebo|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline~Placebo: Placebo to be used four times a day to the affected eye for 2 weeks"
10778811|NCT03861728|BG002|Baseline|Total|Total of all reporting groups
11193285|NCT02144259|FG002|Participant Flow|Control Group|Subjects selecting their own method of contraception or no contraception.
11193286|NCT02144259|OG000|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
10778812|NCT03861728|FG000|Participant Flow|Viral Conjunctivitis Treatment|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid~0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)"
10778813|NCT03861728|FG001|Participant Flow|Viral Conjunctivitis Placebo|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline~Placebo: Placebo to be used four times a day to the affected eye for 2 weeks"
10778814|NCT03861728|OG000|Outcome|Viral Conjunctivitis Treatment|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid~0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)"
10778815|NCT03861728|OG001|Outcome|Viral Conjunctivitis Placebo|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline~Placebo: Placebo to be used four times a day to the affected eye for 2 weeks"
10778816|NCT03861728|EG000|Reported Event|Viral Conjunctivitis Treatment|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid~0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)"
10778817|NCT03861728|EG001|Reported Event|Viral Conjunctivitis Placebo|"Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline~Placebo: Placebo to be used four times a day to the affected eye for 2 weeks"
10778818|NCT03857542|BG000|Baseline|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10778819|NCT03857542|BG001|Baseline|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10778820|NCT03857542|BG002|Baseline|Total|Total of all reporting groups
10778821|NCT03857542|FG000|Participant Flow|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10778822|NCT03857542|FG001|Participant Flow|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine hydrochloride (HCl) ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10778823|NCT03857542|OG000|Outcome|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10778824|NCT03857542|OG001|Outcome|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10778825|NCT03857542|OG001|Outcome|Pilocarpine HCl Ophthalmic Solution 1.25%|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10778826|NCT03857542|EG000|Reported Event|Vehicle|Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
10778827|NCT03857542|EG001|Reported Event|Pilocarpine HCl Ophthalmic Solution|Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
10801081|NCT02633267|OG000|Outcome|Usual Vocational Services + CBT|"This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.~Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801082|NCT02633267|OG001|Outcome|Usual Vocational Services|"This is the care as usual intervention - Vocational services as usually delivered to service seeking clients~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801083|NCT02633267|EG000|Reported Event|Usual Vocational Services + CBT|"This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.~Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801084|NCT02633267|EG001|Reported Event|Usual Vocational Services|"This is the care as usual intervention - Vocational services as usually delivered to service seeking clients~Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)"
10801085|NCT02573493|BG000|Baseline|Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates.~CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10803659|NCT02846532|FG000|Participant Flow|Rivaroxaban (Part A)|Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
10778828|NCT03848832|BG000|Baseline|5 mg/kg/Day GWP42003-P|Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).
10778829|NCT03848832|BG001|Baseline|15 mg/kg/Day GWP42003-P|Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.
10778830|NCT03848832|BG002|Baseline|Placebo|Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
10778831|NCT03848832|BG003|Baseline|Total|Total of all reporting groups
10778832|NCT03848832|FG000|Participant Flow|5 mg/kg/Day GWP42003-P|Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).
10778833|NCT03848832|FG001|Participant Flow|15 mg/kg/Day GWP42003-P|Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.
10778834|NCT03848832|FG002|Participant Flow|Placebo|Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
10778835|NCT03848832|OG000|Outcome|15 mg/kg/Day GWP42003-P|Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.
10778836|NCT03848832|OG001|Outcome|Placebo|Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
10778837|NCT03848832|OG000|Outcome|5 mg/kg/Day GWP42003-P|Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).
10778838|NCT03848832|OG001|Outcome|15 mg/kg/Day GWP42003-P|Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.
10778839|NCT03848832|OG002|Outcome|Placebo|Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
11193287|NCT02144259|OG001|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
10778840|NCT03848832|EG000|Reported Event|5 mg/kg/Day GWP42003-P|Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).
10778841|NCT03848832|EG001|Reported Event|15 mg/kg/Day GWP42003-P|Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.
10778842|NCT03848832|EG002|Reported Event|Placebo|Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
10778843|NCT03688802|BG000|Baseline|OC-01, 1.2 mg/mL|OC-01: OC-01 (varenicline) nasal spray
10778844|NCT03688802|BG001|Baseline|Placebo|Placebo (vehicle) nasal spray: Placebo
10778845|NCT03688802|BG002|Baseline|Total|Total of all reporting groups
10778846|NCT03688802|FG000|Participant Flow|OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray"
10778847|NCT03688802|FG001|Participant Flow|Placebo (Vehicle Control) Nasal Spray|"Placebo (vehicle control) nasal spray~Placebo (vehicle control) nasal spray: Placebo"
10778848|NCT03688802|OG000|Outcome|OC-01, 1.2 mg/mL|OC-01: OC-01 (varenicline) nasal spray
10778849|NCT03688802|OG001|Outcome|Placebo|Placebo: Placebo Vehicle ) nasal spray
10778850|NCT03688802|EG000|Reported Event|OC-01, 1.2 mg/mL|OC-01 (varenicline) nasal spray, 1.2 mg/mL
10778851|NCT03688802|EG001|Reported Event|Placebo|Placebo (vehicle control) nasal spray
10778852|NCT03656744|BG000|Baseline|500mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778853|NCT03656744|BG001|Baseline|1000mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778854|NCT03656744|BG002|Baseline|Placebo, Bid|Placebo: tablets manufactured to mimic HTD1801 tablets
10778855|NCT03656744|BG003|Baseline|Total|Total of all reporting groups
10778856|NCT03656744|FG000|Participant Flow|500mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778857|NCT03656744|FG001|Participant Flow|1000mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778858|NCT03656744|FG002|Participant Flow|Placebo, Bid|Placebo: tablets manufactured to mimic HTD1801 tablets
10778859|NCT03656744|OG000|Outcome|500mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778860|NCT03656744|OG001|Outcome|1000mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778861|NCT03656744|OG002|Outcome|Placebo, Bid|Placebo: tablets manufactured to mimic HTD1801 tablets
10778862|NCT03656744|EG000|Reported Event|500mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778863|NCT03656744|EG001|Reported Event|1000mg HTD1801, Bid|HTD1801: HTD1801 tablets, 250mg
10778864|NCT03656744|EG002|Reported Event|Placebo, Bid|Placebo: tablets manufactured to mimic HTD1801 tablets
10778865|NCT03510598|BG000|Baseline|Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella|All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
10778866|NCT03510598|FG000|Participant Flow|Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella|All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
10778867|NCT03510598|OG000|Outcome|Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella|All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
10778868|NCT03510598|EG000|Reported Event|Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella|All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
10850567|NCT00303472|BG002|Baseline|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850568|NCT00303472|BG003|Baseline|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10778869|NCT03487796|BG000|Baseline|MySTYLE Adolescents|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778870|NCT03487796|BG001|Baseline|Waitlist Control Adolescents|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778871|NCT03487796|BG002|Baseline|MySTYLE Trusted Adults|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778872|NCT03487796|BG003|Baseline|Waitlist Control Trusted Adults|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778873|NCT03487796|BG004|Baseline|Total|Total of all reporting groups
10778874|NCT03487796|FG000|Participant Flow|MySTYLE|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778875|NCT03487796|FG001|Participant Flow|Waitlist Control|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778876|NCT03487796|OG000|Outcome|MySTYLE|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10803660|NCT02846532|FG001|Participant Flow|Rivaroxaban (Part B)|Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
11193288|NCT02144259|OG002|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
10778877|NCT03487796|OG001|Outcome|Waitlist Control|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778878|NCT03487796|OG000|Outcome|MySTYLE Adolescents|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778879|NCT03487796|OG001|Outcome|Waitlist Control Adolescents|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778880|NCT03487796|OG002|Outcome|MySTYLE Trusted Adults|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778881|NCT03487796|OG003|Outcome|Waitlist Control Trusted Adults|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778882|NCT03487796|EG000|Reported Event|MySTYLE Adolescents|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10803661|NCT02846532|FG002|Participant Flow|Aspirin (Part B)|Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
11193289|NCT02144259|EG000|Reported Event|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
11193290|NCT02144259|EG001|Reported Event|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
11193291|NCT02144259|EG002|Reported Event|Control Group|Subjects selecting their own method of contraception or no contraception.
11193292|NCT02144285|BG000|Baseline|Placebo (Part A)|Single dose of placebo matching LY3113593.
11193293|NCT02144285|BG001|Baseline|LY IV 1.5mg (Part A)|Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
11193294|NCT02144285|BG002|Baseline|LY IV 5mg (Part A)|Single dose of LY3113593 administered intravenous (IV) at 5 mg.
11193295|NCT02144285|BG003|Baseline|LY IV 15mg (Part A)|Single dose of LY3113593 administered IV at 15 mg.
11193296|NCT02144285|BG004|Baseline|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg.
11193297|NCT02144285|BG005|Baseline|LY IV 150mg (Part A)|Single dose of LY3113593 administered IV at 150 mg.
11193298|NCT02144285|BG006|Baseline|LY IV 400mg (Part A)|Single dose of LY3113593 administered IV at 400 mg.
11193299|NCT02144285|BG007|Baseline|LY SC 150mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193300|NCT02144285|BG008|Baseline|Placebo IV (Part B)|Single dose of placebo matching LY3113593 administered IV.
11193301|NCT02144285|BG009|Baseline|LY IV 150mg (Part B)|Single dose of LY3113593 administered IV at 150 mg.
11193302|NCT02144285|BG010|Baseline|Total|Total of all reporting groups
11193303|NCT02144285|FG000|Participant Flow|Placebo (Part A)|Single dose of placebo matching LY3113593.
11193304|NCT02144285|FG001|Participant Flow|LY IV 1.5mg (Part A)|Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
11193305|NCT02144285|FG002|Participant Flow|LY IV 5mg (Part A)|Single dose of LY3113593 administered intravenous (IV) at 5 mg.
10778883|NCT03487796|EG001|Reported Event|Waitlist Control Adolescents|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778884|NCT03487796|EG002|Reported Event|MySTYLE Trusted Adults|"MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.~MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10849938|NCT00299182|OG002|Outcome|Arm A 10mcg/kg|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11193306|NCT02144285|FG003|Participant Flow|LY IV 15mg (Part A)|Single dose of LY3113593 administered IV at 15 mg.
11193307|NCT02144285|FG004|Participant Flow|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg.
11193308|NCT02144285|FG005|Participant Flow|LY IV 150mg (Part A)|Single dose of LY3113593 administered IV at 150 mg.
11193309|NCT02144285|FG006|Participant Flow|LY IV 400mg (Part A)|Single dose of LY3113593 administered IV at 400 mg.
11193310|NCT02144285|FG007|Participant Flow|LY SC 150mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193311|NCT02144285|FG008|Participant Flow|Placebo IV (Part B)|Single dose of placebo matching LY3113593 administered IV.
11193312|NCT02144285|FG009|Participant Flow|LY IV 150mg(Part B)|Single dose of LY3113593 administered IV at 150 mg.
11193313|NCT02144285|OG000|Outcome|Placebo (Part A)|Single dose of placebo matching LY3113593.
11193314|NCT02144285|OG001|Outcome|LY IV 1.5mg (Part A)|Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
11193315|NCT02144285|OG002|Outcome|LY IV 5mg (Part A)|Single dose of LY3113593 administered intravenous (IV) at 5 mg.
11193316|NCT02144285|OG003|Outcome|LY IV 15mg (Part A)|Single dose of LY3113593 administered IV at 15 mg.
11193317|NCT02144285|OG004|Outcome|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg.
11193318|NCT02144285|OG005|Outcome|LY IV 150mg (Part A)|Single dose of LY3113593 administered IV at 150 mg.
11193319|NCT02144285|OG006|Outcome|LY IV 400mg (Part A)|Single dose of LY3113593 administered IV at 400 mg.
11193320|NCT02144285|OG007|Outcome|LY SC 150mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193321|NCT02144285|OG008|Outcome|Placebo IV (Part B)|Single dose of LY3113593 administered IV.
11193322|NCT02144285|OG009|Outcome|LY IV 150mg (Part B)|Single dose of LY3113593 administered IV at 150 mg.
11193323|NCT02144285|OG000|Outcome|LY IV 1.5mg (Part A)|Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
11193324|NCT02144285|OG001|Outcome|LY IV 5mg (Part A)|Single dose of LY3113593 administered intravenous (IV) at 5 mg.
11193325|NCT02144285|OG002|Outcome|LY IV 15mg (Part A)|Single dose of LY3113593 administered IV at 15 mg.
11193326|NCT02144285|OG003|Outcome|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg.
11193327|NCT02144285|OG004|Outcome|LY IV 150mg (Part A)|Single dose of LY3113593 administered IV at 150 mg.
11193328|NCT02144285|OG005|Outcome|LY IV 400mg (Part A)|Single dose of LY3113593 administered IV at 400 mg.
11193329|NCT02144285|OG006|Outcome|LY SC 150 mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193330|NCT02144285|OG007|Outcome|LY IV 150 mg (Part B)|Single dose of LY3113593 administered IV at 150mg.
11193331|NCT02144285|OG007|Outcome|LY IV 150mg (Part B)|Single dose of LY3113593 administered IV at 150 mg.
11193332|NCT02144285|OG000|Outcome|LY SC 150mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193333|NCT02144285|OG001|Outcome|LY IV 150mg (Part A)|Single dose of LY3113593 (LY) administered IV at 150 mg.
11193334|NCT02144285|OG008|Outcome|Placebo IV (Part B)|Single dose of placebo matching LY3113593 administered IV.
11193335|NCT02144285|OG009|Outcome|LY IV (Part B)|Single dose of LY3113593 administered IV.
11193336|NCT02144285|OG004|Outcome|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg
11193337|NCT02144285|EG000|Reported Event|Placebo (Part A)|Single dose of placebo matching LY3113593.
10778885|NCT03487796|EG003|Reported Event|Waitlist Control Trusted Adults|"Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.~Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication."
10778886|NCT03446612|BG000|Baseline|Daprodustat|Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
10778887|NCT03446612|BG001|Baseline|Darbepoetin Alfa|Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
10778888|NCT03446612|BG002|Baseline|Total|Total of all reporting groups
10778889|NCT03446612|FG000|Participant Flow|Daprodustat|Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
10778890|NCT03446612|FG001|Participant Flow|Darbepoetin Alfa|Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
10778891|NCT03446612|OG000|Outcome|Daprodustat|Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
10778892|NCT03446612|OG001|Outcome|Darbepoetin Alfa|Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
10778893|NCT03446612|OG000|Outcome|Darbepoetin Alfa|Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
10778894|NCT03446612|OG000|Outcome|Daprodustat|Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days
10778895|NCT03446612|EG000|Reported Event|Daprodustat|Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
10778896|NCT03446612|EG001|Reported Event|Darbepoetin Alfa|Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
10778897|NCT03436433|BG000|Baseline|Lacosamide|"Enrolled subjects will be randomized to receive Lacosamide.~Lacosamide: LCM 100mg twice a day."
10778898|NCT03436433|BG001|Baseline|Levetiracetam|"Enrolled subjects will be randomized to receive Levetiracetam.~Levetiracetam: LEV 1000mg twice a day."
10778899|NCT03436433|BG002|Baseline|No Anti-epileptic|Enrolled subjects will be randomized to not receive anti-epileptic drugs.
10778900|NCT03436433|BG003|Baseline|Total|Total of all reporting groups
10778901|NCT03436433|FG000|Participant Flow|Lacosamide|"Enrolled subjects will be randomized to receive Lacosamide.~Lacosamide: LCM 100mg twice a day."
10778902|NCT03436433|FG001|Participant Flow|Levetiracetam|"Enrolled subjects will be randomized to receive Levetiracetam.~Levetiracetam: LEV 1000mg twice a day."
10778903|NCT03436433|FG002|Participant Flow|No Anti-epileptic|Enrolled subjects will be randomized to not receive anti-epileptic drugs.
10778904|NCT03436433|OG000|Outcome|Lacosamide|"Enrolled subjects will be randomized to receive Lacosamide.~Lacosamide: LCM 100mg twice a day."
10778905|NCT03436433|OG001|Outcome|Levetiracetam|"Enrolled subjects will be randomized to receive Levetiracetam.~Levetiracetam: LEV 1000mg twice a day."
10778906|NCT03436433|OG002|Outcome|No Anti-epileptic|Enrolled subjects will be randomized to not receive anti-epileptic drugs.
10778907|NCT03436433|EG000|Reported Event|Lacosamide|"Enrolled subjects will be randomized to receive Lacosamide.~Lacosamide: LCM 100mg twice a day."
10778908|NCT03436433|EG001|Reported Event|Levetiracetam|"Enrolled subjects will be randomized to receive Levetiracetam.~Levetiracetam: LEV 1000mg twice a day."
10778909|NCT03436433|EG002|Reported Event|No Anti-epileptic|Enrolled subjects will be randomized to not receive anti-epileptic drugs.
10778910|NCT03370120|BG000|Baseline|Padsevonil|Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years.
10778911|NCT03370120|FG000|Participant Flow|Padsevonil|Participants received padsevonil tablets at a dose of 100 milligrams/day (mg/day) to 800 mg/day up to approximately 2 years.
10778912|NCT03370120|OG000|Outcome|Padsevonil (SS)|Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).
10778913|NCT03370120|OG000|Outcome|Padsevonil (SS)|Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
10778914|NCT03370120|OG000|Outcome|Padsevonil (FAS)|Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the FAS.
10778915|NCT03370120|EG000|Reported Event|Padsevonil (SS)|Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
10778916|NCT03367429|BG000|Baseline|Exp 1 - ARM 1|Standard injection in LGM
10778917|NCT03367429|BG001|Baseline|Exp 1 - ARM 2|experimental injection in LGM
10778918|NCT03367429|BG002|Baseline|Exp 1 - ARM 3|experimental injection in MGM
10778919|NCT03367429|BG003|Baseline|Total|Total of all reporting groups
10778920|NCT03367429|FG000|Participant Flow|Exp 1 - ARM 1|Standard injection in LGM
10778921|NCT03367429|FG001|Participant Flow|Exp 1 - ARM 2|experimental injection in LGM
10778922|NCT03367429|FG002|Participant Flow|Exp 1 - ARM 3|experimental injection in MGM
10850569|NCT00303472|BG004|Baseline|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10778923|NCT03367429|OG000|Outcome|Exp 2 & 3 - Arm 1|"If within-subject design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM and one standard BT injection of of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic MGM.~If between-subjects design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM.~Botox: Please see arm descriptions for intervention description."
10778924|NCT03367429|OG001|Outcome|Exp 2 & 3 - Arm 2|"If within-subject study design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM and one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic MGM.~If between-subjects design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM.~Botox: Please see arm descriptions for intervention description."
10778925|NCT03367429|EG000|Reported Event|Exp 2 & 3 - Arm 1|"If within-subject design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM and one standard BT injection of of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic MGM.~If between-subjects design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM.~Botox: THE PROTOCOL DESCRIPTION ATTEMPTED TO OUTLINE A CONTINGINECY PLAN- MOVING TO ONE OF TWO METHODOLOGOIES DPENDING ON PRELIMINARY FINDINGS. UNFORTUNATLEY, OVER 2 YEARS RECRUITMENT WAS GROSSLY INADEQUATE PREVENTING ANY TYPE OF EVEN CURSURY PRELIMINARY DATA ANALYSIS AND FORCING THE EARLY TERMINATION OF THIS STUDY. MICHAEL W. O'DELL, MD"
10778926|NCT03367429|EG001|Reported Event|Exp 2 & 3 - Arm 2|"If within-subject study design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM and one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic MGM.~If between-subjects design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM.~Botox: THE PROTOCOL DESCRIPTION ATTEMPTED TO OUTLINE A CONTINGINECY PLAN- MOVING TO ONE OF TWO METHODOLOGOIES DPENDING ON PRELIMINARY FINDINGS. UNFORTUNATLEY, OVER 2 YEARS RECRUITMENT WAS GROSSLY INADEQUATE PREVENTING ANY TYPE OF EVEN CURSURY PRELIMINARY DATA ANALYSIS AND FORCING THE EARLY TERMINATION OF THIS STUDY. MICHAEL W. O'DELL, MD"
10778927|NCT03367429|EG002|Reported Event|Exp 1 - Arm Unknown|The arm-group assignment of one participant is not known.
10778928|NCT03367429|EG003|Reported Event|Exp 1 Arm 1|Standard Injection in LGM
10778929|NCT03367429|EG004|Reported Event|Exp 1 Arm 2|Experimental Injection in LGM
10778930|NCT03367429|EG005|Reported Event|Exp 1 - Arm 3|Experimental Injection in MGM
10778931|NCT03143829|BG000|Baseline|Intervention Group|"electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778932|NCT03143829|BG001|Baseline|Wait Control Group|"The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778933|NCT03143829|BG002|Baseline|Total|Total of all reporting groups
10778934|NCT03143829|FG000|Participant Flow|Intervention Group|"electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778935|NCT03143829|FG001|Participant Flow|Wait Control Group|"The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778936|NCT03143829|OG000|Outcome|Intervention Group|"electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778937|NCT03143829|OG001|Outcome|Wait Control Group|"The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778938|NCT03143829|EG000|Reported Event|Intervention Group|"electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778939|NCT03143829|EG001|Reported Event|Wait Control Group|"The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.~eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home."
10778940|NCT03099863|BG000|Baseline|Standard Care|"Standard cystoscopy with normal saline solution.~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery~Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid"
10778941|NCT03099863|BG001|Baseline|Neosporin G. U. Irrigant|"Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.~Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery"
10778942|NCT03099863|BG002|Baseline|Total|Total of all reporting groups
10778943|NCT03099863|FG000|Participant Flow|Standard Care|"Standard cystoscopy with normal saline solution.~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery~Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid"
10778944|NCT03099863|FG001|Participant Flow|Neosporin G. U. Irrigant|"Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.~Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery"
10778945|NCT03099863|OG000|Outcome|Standard Care|"Standard cystoscopy with normal saline solution.~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery~Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid"
10778946|NCT03099863|OG001|Outcome|Neosporin G. U. Irrigant|"Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.~Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery"
10778947|NCT03099863|EG000|Reported Event|Standard Care|"Standard cystoscopy with normal saline solution.~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery~Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid"
10778948|NCT03099863|EG001|Reported Event|Neosporin G. U. Irrigant|"Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.~Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL~Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery"
10778949|NCT02963610|BG000|Baseline|Pembrolizumab, Lenalidomide|"Phase I The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. The dose of lenalidomide will depend upon the patient cohort. Cohort 1 will receive 10mg, Cohort II will receive 15mg and cohort 3 will receive 20mg of lenalidomide.~Phase II The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. Maximum Tolerated Dose (MTD) of lenalidomide as determined by the Phase I study will be given in Phase II study.~Lenalidomide: Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.~Pembrolizumab: Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer."
10778950|NCT02963610|FG000|Participant Flow|Pembrolizumab, Lenalidomide|"Phase I The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. The dose of lenalidomide will depend upon the patient cohort. Cohort 1 will receive 10mg, Cohort II will receive 15mg and cohort 3 will receive 20mg of lenalidomide.~Phase II The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. Maximum Tolerated Dose (MTD) of lenalidomide as determined by the Phase I study will be given in Phase II study.~Lenalidomide: Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.~Pembrolizumab: Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer."
11193338|NCT02144285|EG001|Reported Event|LY IV 1.5mg (Part A)|Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
11193339|NCT02144285|EG002|Reported Event|LY IV 5mg (Part A)|Single dose of LY3113593 administered intravenous (IV) at 5 mg.
11193340|NCT02144285|EG003|Reported Event|LY IV 15mg (Part A)|Single dose of LY3113593 administered IV at 15 mg.
11193341|NCT02144285|EG004|Reported Event|LY IV 50mg (Part A)|Single dose of LY3113593 administered IV at 50 mg.
11193342|NCT02144285|EG005|Reported Event|LY IV 150mg (Part A)|Single dose of LY3113593 administered IV at 150 mg.
11193343|NCT02144285|EG006|Reported Event|LY IV 400mg (Part A)|Single dose of LY3113593 administered IV at 400 mg.
11193344|NCT02144285|EG007|Reported Event|LY SC 150mg (Part A)|Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
11193345|NCT02144285|EG008|Reported Event|Placebo IV (Part B)|Single dose of placebo matching LY3113593 administered IV.
11193346|NCT02144285|EG009|Reported Event|LY IV (Part B)|Single dose of LY3113593 administered IV.
11240935|NCT02482870|OG000|Outcome|Macintosh|Using a Macintosh laryngoscope, best Cormack-Lehane score obtained has been recorded.
10778951|NCT02963610|OG000|Outcome|Experimental: Pembrolizumab, Lenalidomide|"Phase I The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. The dose of lenalidomide will depend upon the patient cohort. Cohort 1 will receive 10mg, Cohort II will receive 15mg and cohort 3 will receive 20mg of lenalidomide.~Phase II The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. Maximum Tolerated Dose (MTD) of lenalidomide as determined by the Phase I study will be given in Phase II study.~Lenalidomide: Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.~Pembrolizumab: Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer."
10778952|NCT02963610|OG000|Outcome|Pembrolizumab, Lenalidomide|"Phase I The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. The dose of lenalidomide will depend upon the patient cohort. Cohort 1 will receive 10mg, Cohort II will receive 15mg and cohort 3 will receive 20mg of lenalidomide.~Phase II The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. Maximum Tolerated Dose (MTD) of lenalidomide as determined by the Phase I study will be given in Phase II study.~Lenalidomide: Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.~Pembrolizumab: Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer."
10778953|NCT02963610|EG000|Reported Event|Pembrolizumab, Lenalidomide|"Phase I The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. The dose of lenalidomide will depend upon the patient cohort. Cohort 1 will receive 10mg, Cohort II will receive 15mg and cohort 3 will receive 20mg of lenalidomide.~Phase II The treatment will be given on a 21-day cycle, with a dose of pembrolizumab given on day1(IV) and doses of lenalidomide given on day 1-14 (orally). The dose of pembrolizumab will be fixed at 200 mg. Maximum Tolerated Dose (MTD) of lenalidomide as determined by the Phase I study will be given in Phase II study.~Lenalidomide: Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.~Pembrolizumab: Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer."
10778954|NCT02766335|BG000|Baseline|Arm I (MEDI4736 - Closed to Accrual 12/2015)|"Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778955|NCT02766335|BG001|Baseline|Arm II (Docetaxel - Closed to Accrual 4/2015)|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778956|NCT02766335|BG002|Baseline|Total|Total of all reporting groups
10778957|NCT02766335|FG000|Participant Flow|Arm I (MEDI4736 - Closed to Accrual 12/2015)|"Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778958|NCT02766335|FG001|Participant Flow|Arm II (Docetaxel - Closed to Accrual 4/2015)|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778959|NCT02766335|FG002|Participant Flow|Arm III - MEDI4736 Retreatment|"For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778960|NCT02766335|OG000|Outcome|Arm I (MEDI4736 - Closed to Accrual 12/2015)|"Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778961|NCT02766335|OG001|Outcome|Arm II (Docetaxel - Closed to Accrual 4/2015)|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11240936|NCT02482870|OG001|Outcome|King Vision Video Laryngoscope|Using a King Vision video laryngoscope, best Cormack-Lehane score obtained has been recorded.
10778962|NCT02766335|EG000|Reported Event|Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)|"Arm I- Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.~Arm III-For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Arm III~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10778963|NCT02766335|EG001|Reported Event|Arm II (Docetaxel - Closed to Accrual 4/2015)|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10801086|NCT02573493|BG001|Baseline|Arm 2: Nab-Paclitaxel (A) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment~If CR/PR, three more weeks of nab-paclitaxel followed by CRT~If <PR, move directly to CRT if not surgical candidates.~CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.~It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801087|NCT02573493|BG002|Baseline|Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab~CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801088|NCT02573493|BG003|Baseline|Not Enrolled in Any Arm|-Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
10801089|NCT02573493|BG004|Baseline|Total|Total of all reporting groups
10801090|NCT02573493|FG000|Participant Flow|Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates.~CRT includes cisplatin (if cannot receive cisplain will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10803662|NCT02846532|OG000|Outcome|Rivaroxaban (Part A)|Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
11193347|NCT02144337|BG000|Baseline|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
11193348|NCT02144337|BG001|Baseline|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
11193349|NCT02144337|BG002|Baseline|Total|Total of all reporting groups
11193350|NCT02144337|FG000|Participant Flow|Intervention Group|6 week Steps To Active Kids (STAK) programme includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 - 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress.
11193351|NCT02144337|FG001|Participant Flow|Control Group|Control group. Children in the Control group are asked to continue normal daily activities.
11193352|NCT02144337|OG000|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
11193353|NCT02144337|OG001|Outcome|Control Group|No intervention
11193354|NCT02144337|OG000|Outcome|Overall Study Group Sample|Intervention and control group combined
11193355|NCT02144337|EG000|Reported Event|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
11193356|NCT02144337|EG001|Reported Event|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
11240937|NCT02482870|OG000|Outcome|Macintosh|Airway complications related to the use of Macintosh laryngoscope has been recorded.
11240938|NCT02482870|OG001|Outcome|King Vision Video Laryngoscope|Airway complications related to the use of King Vision video laryngoscope has been recorded.
11193357|NCT02139540|BG000|Baseline|N2O/Placebo|"First session: Nitrous oxide Second session: placebo~Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or placebo (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.~Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup"
11193358|NCT02139540|BG001|Baseline|Placebo/N2O|"First session: Placebo Second session: Nitrous Oxide~Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or placebo (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.~Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup"
10778964|NCT02606136|BG000|Baseline|Pamrevlumab|Participants received pamrevlumab 35 mg/kg by IV infusion every 2 weeks for a minimum of 104 weeks.
10778965|NCT02606136|FG000|Participant Flow|Pamrevlumab|Participants received pamrevlumab 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 2 weeks for a minimum of 104 weeks.
10778966|NCT02606136|OG000|Outcome|Pamrevlumab|Participants received pamrevlumab 35 mg/kg by IV infusion every 2 weeks for a minimum of 104 weeks.
10778967|NCT02606136|EG000|Reported Event|Pamrevlumab|Participants received pamrevlumab 35 mg/kg by IV infusion every 2 weeks for a minimum of 104 weeks.
10778968|NCT02228382|BG000|Baseline|Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
10778969|NCT02228382|BG001|Baseline|Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
10778970|NCT02228382|BG002|Baseline|Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
10778971|NCT02228382|BG003|Baseline|Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
10778972|NCT02228382|BG004|Baseline|Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia|Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
10778973|NCT02228382|BG005|Baseline|Total|Total of all reporting groups
10778974|NCT02228382|FG000|Participant Flow|Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia resistant or intolerant to imatinib, dasatinib, or nilotinib received bosutinib 500 milligram (mg), orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
11193359|NCT02139540|BG002|Baseline|Total|Total of all reporting groups
11193360|NCT02139540|FG000|Participant Flow|N2O/Placebo|"First session: Nitrous oxide Second session: placebo~Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or placebo (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.~Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup"
11193361|NCT02139540|FG001|Participant Flow|Placebo/N2O|"First session: Placebo Second session: Nitrous Oxide~Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or placebo (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.~Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup"
10778975|NCT02228382|FG001|Participant Flow|Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia resistant or intolerant to imatinib and/or dasatinib and/or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
10778976|NCT02228382|FG002|Participant Flow|Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia resistant or intolerant to imatinib and dasatinib and nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
10778977|NCT02228382|FG003|Participant Flow|Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia resistant or intolerant to at least one tyrosine kinase inhibitor among imatinib, dasatinib, or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
10778978|NCT02228382|FG004|Participant Flow|Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia|Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
11193362|NCT02139540|OG000|Outcome|Nitrous Oxide|
11193363|NCT02139540|OG001|Outcome|Placebo|Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
11193364|NCT02139540|EG000|Reported Event|Nitrous Oxide|
11193365|NCT02139540|EG001|Reported Event|Placebo|Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
11379001|NCT04158219|FG000|Participant Flow|Treatment|"Behavioral activation for health and depression (BA-HD)~Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes)."
11379002|NCT04158219|OG000|Outcome|Treatment|"Behavioral activation for health and depression (BA-HD)~Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes)."
11379003|NCT04158219|EG000|Reported Event|Treatment|"Behavioral activation for health and depression (BA-HD)~Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes)."
11379004|NCT04131959|BG000|Baseline|CytoSorb 300 mL Device Treatment Population|Single arm
11379005|NCT04131959|FG000|Participant Flow|CytoSorb 300 mL Device Treatment Population|Single arm
11379006|NCT04131959|OG000|Outcome|CytoSorb 300 mL Device Treatment Population|Single arm
11379007|NCT04131959|OG000|Outcome|Pharmacodynamic Population|Single arm
11379008|NCT04131959|EG000|Reported Event|CytoSorb 300 mL Device Treatment Population|Single arm
11379009|NCT04084990|BG000|Baseline|aPAP|"Nightly use of aPAP when sleeping through the date of delivery~S9 VPAP Adapt: Auto-titrated positive airway pressure"
10778979|NCT02228382|OG000|Outcome|Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
11193366|NCT02144519|BG000|Baseline|Delayed Intervention|"This arm served as a comparison group for the first year and received the Healthy Eating and Physical Activity intervention in year 3 along with arm 1.~Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards."
11379010|NCT04084990|BG001|Baseline|No aPAP|No use of aPAP (standard of care)
11379011|NCT04084990|BG002|Baseline|Total|Total of all reporting groups
11379012|NCT04084990|FG000|Participant Flow|aPAP|"Nightly use of aPAP when sleeping through the date of delivery~S9 VPAP Adapt: Auto-titrated positive airway pressure"
11379013|NCT04084990|FG001|Participant Flow|No aPAP|No use of aPAP (standard of care)
11379014|NCT04084990|OG000|Outcome|aPAP|"Nightly use of aPAP when sleeping through the date of delivery~S9 VPAP Adapt: Auto-titrated positive airway pressure"
11379015|NCT04084990|OG001|Outcome|No aPAP|No use of aPAP (standard of care)
11379016|NCT04084990|EG000|Reported Event|aPAP|"Nightly use of aPAP when sleeping through the date of delivery~S9 VPAP Adapt: Auto-titrated positive airway pressure"
11379017|NCT04084990|EG001|Reported Event|No aPAP|No use of aPAP (standard of care)
11379018|NCT04056299|BG000|Baseline|AR201 Powder|"Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks~AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules"
11379019|NCT04056299|BG001|Baseline|Placebo Powder|"Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.~Placebo powder: Placebo powder provided in capsules"
11379020|NCT04056299|BG002|Baseline|Total|Total of all reporting groups
11379021|NCT04056299|FG000|Participant Flow|AR201 Powder|"Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks~AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules"
11379022|NCT04056299|FG001|Participant Flow|Placebo Powder|"Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.~Placebo powder: Placebo powder provided in capsules"
11379023|NCT04056299|OG000|Outcome|AR201 Powder|"Study product provided as dried egg white in pull-apart capsules.~AR201 powder in capsules: AR201 powder (Hen Egg allergen formulation) formulated to contain dried egg white at different dosage strengths."
11379024|NCT04056299|OG001|Outcome|Placebo Powder|"Placebo formulation in pull-apart capsules containing only inactive ingredients~Placebo powder provided in capsules: Placebo powder formulated to match the color and texture of dried egg white."
11379025|NCT04056299|EG000|Reported Event|AR201 Powder|"Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks~AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules"
10778980|NCT02228382|OG000|Outcome|Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
11193367|NCT02144519|BG001|Baseline|Immediate Intervention|"This arm receives the Healthy Eating and Physical Activity intervention in ASPs intervention immediately for a full year before the delayed intervention begins. This arm gets the intervention and support for two years.~Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards."
11193368|NCT02144519|BG002|Baseline|Total|Total of all reporting groups
11193369|NCT02144519|FG000|Participant Flow|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
11193370|NCT02144519|FG001|Participant Flow|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
11193371|NCT02144519|OG000|Outcome|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
11193372|NCT02144519|OG001|Outcome|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
11193373|NCT02144519|EG000|Reported Event|Delayed Intervention|Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
11193374|NCT02144519|EG001|Reported Event|Immediate Intervention|Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
11193375|NCT02144597|BG000|Baseline|2-week LCD and Roux-en-Y Gastric Bypass (RYGB)|"A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery"
11193376|NCT02144597|BG001|Baseline|6-week LCD|"A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan."
11193377|NCT02144597|BG002|Baseline|Control Diet|"1000 calorie diet~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery~Control diet"
11193378|NCT02144597|BG003|Baseline|Total|Total of all reporting groups
11193379|NCT02144597|FG000|Participant Flow|2-week LCD and Roux-en-Y Gastric Bypass (RYGB)|"A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery"
11193380|NCT02144597|FG001|Participant Flow|6-week LCD|"A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan."
11193381|NCT02144597|FG002|Participant Flow|Control Diet|"1000 calorie diet~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery~Control diet"
11193382|NCT02144597|OG000|Outcome|2-week LCD and Roux-en-Y Gastric Bypass (RYGB)|"A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery"
11193383|NCT02144597|OG001|Outcome|6-week LCD|"A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan."
11193384|NCT02144597|OG002|Outcome|Control Diet|"1000 calorie diet~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery~Control diet"
11193385|NCT02144597|EG000|Reported Event|2-week LCD and Roux-en-Y Gastric Bypass (RYGB)|"A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery"
10778981|NCT02228382|OG000|Outcome|Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
10778982|NCT02228382|OG000|Outcome|Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
10778983|NCT02228382|OG001|Outcome|Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
11379026|NCT04056299|EG001|Reported Event|Placebo Powder|"Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.~Placebo powder: Placebo powder provided in capsules"
10778984|NCT02228382|OG002|Outcome|Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
10778985|NCT02228382|OG003|Outcome|Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
10778986|NCT02228382|OG004|Outcome|Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia|Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
10778987|NCT02228382|OG005|Outcome|Bosutinib: Chronic Myelogenous Leukemia|Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
10778988|NCT02228382|EG000|Reported Event|Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
10778989|NCT02228382|EG001|Reported Event|Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
11193386|NCT02144597|EG001|Reported Event|6-week LCD|"A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups~Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan."
11193387|NCT02144597|EG002|Reported Event|Control Diet|"1000 calorie diet~Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery~Control diet"
10778990|NCT02228382|EG002|Reported Event|Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
10778991|NCT02228382|EG003|Reported Event|Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia|Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
10778992|NCT02228382|EG004|Reported Event|Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia|Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
10778993|NCT02228382|EG005|Reported Event|Bosutinib: Chronic Myelogenous Leukemia|Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
10778994|NCT02090998|BG000|Baseline|Amitriptyline / Elavil|"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10778995|NCT02090998|BG001|Baseline|SPG Nerve Block With Lidocaine 5% Gel|"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10778996|NCT02090998|BG002|Baseline|Total|Total of all reporting groups
10778997|NCT02090998|FG000|Participant Flow|Amitriptyline / Elavil|"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
11193388|NCT02144610|BG000|Baseline|Gene Therapy HGF Plasmid (AMG0001)|"Randomized subjects will receive 4 sets of intramuscular injections of HGF plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~HGF Plasmid (AMG0001): IM"
11193389|NCT02144610|BG001|Baseline|Placebo|"Randomized subjects will receive 4 sets of intramuscular injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~Matching Placebo: IM"
11193390|NCT02144610|BG002|Baseline|Total|Total of all reporting groups
11240939|NCT02482870|EG000|Reported Event|King Vision First, Then Macintosh|These patients had been intubated with a King Vision video laryngoscope first, and then with a Macintosh laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
10778998|NCT02090998|FG001|Participant Flow|SPG Nerve Block With Lidocaine 5% Gel|"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10778999|NCT02090998|OG000|Outcome|Amitriptyline / Elavil|"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10779000|NCT02090998|OG001|Outcome|SPG Nerve Block With Lidocaine 5% Gel|"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10779001|NCT02090998|EG000|Reported Event|Amitriptyline / Elavil|"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10779002|NCT02090998|EG001|Reported Event|SPG Nerve Block With Lidocaine 5% Gel|"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated~SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia~Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"
10779003|NCT02051309|BG000|Baseline|Guanfacine 6mg/Day ER|"Guanfacine 6mg/day extended release~Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication."
10779004|NCT02051309|BG001|Baseline|Placebo|"Placebo matching capsule~Placebo"
10779005|NCT02051309|BG002|Baseline|Total|Total of all reporting groups
10779006|NCT02051309|FG000|Participant Flow|Guanfacine 6mg/Day ER|"Guanfacine 6mg/day extended release~Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication."
10779007|NCT02051309|FG001|Participant Flow|Placebo|"Placebo matching capsule~Placebo"
10779008|NCT02051309|OG000|Outcome|Guanfacine 6mg/Day ER|"Guanfacine 6mg/day extended release~Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication."
10779009|NCT02051309|OG001|Outcome|Placebo|"Placebo matching capsule~Placebo"
10779010|NCT02051309|EG000|Reported Event|Guanfacine 6mg/Day ER|"Guanfacine 6mg/day extended release~Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication."
10779011|NCT02051309|EG001|Reported Event|Placebo|"Placebo matching capsule~Placebo"
10779012|NCT02001623|BG000|Baseline|Dose Escalation Part: 0.3 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
10779013|NCT02001623|BG001|Baseline|Dose Escalation Part: 0.6 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
10779014|NCT02001623|BG002|Baseline|Dose Escalation Part: 0.9 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
10779015|NCT02001623|BG003|Baseline|Dose Escalation Part: 1.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
10779016|NCT02001623|BG004|Baseline|Dose Escalation Part: 1.5 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
10779017|NCT02001623|BG005|Baseline|Dose Escalation Part: 1.8 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
10779018|NCT02001623|BG006|Baseline|Dose Escalation Part: 2.0 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779019|NCT02001623|BG007|Baseline|Dose Escalation Part: 2.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
10779020|NCT02001623|BG008|Baseline|Dose Expansion Part: Bladder Cancer|Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779021|NCT02001623|BG009|Baseline|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779022|NCT02001623|BG010|Baseline|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779023|NCT02001623|BG011|Baseline|Dose Expansion Part: Esophageal Cancer|Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779024|NCT02001623|BG012|Baseline|Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779025|NCT02001623|BG013|Baseline|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779026|NCT02001623|BG014|Baseline|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779027|NCT02001623|BG015|Baseline|Total|Total of all reporting groups
10779028|NCT02001623|FG000|Participant Flow|Dose Escalation Part: 0.3 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
10779029|NCT02001623|FG001|Participant Flow|Dose Escalation Part: 0.6 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
10779030|NCT02001623|FG002|Participant Flow|Dose Escalation Part: 0.9 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
10779031|NCT02001623|FG003|Participant Flow|Dose Escalation Part: 1.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
10779032|NCT02001623|FG004|Participant Flow|Dose Escalation Part: 1.5 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
10779033|NCT02001623|FG005|Participant Flow|Dose Escalation Part: 1.8 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
10779034|NCT02001623|FG006|Participant Flow|Dose Escalation Part: 2.0 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779035|NCT02001623|FG007|Participant Flow|Dose Escalation Part: 2.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
10779036|NCT02001623|FG008|Participant Flow|Dose Expansion Part: Bladder Cancer|Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779037|NCT02001623|FG009|Participant Flow|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779038|NCT02001623|FG010|Participant Flow|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779039|NCT02001623|FG011|Participant Flow|Dose Expansion Part: Esophageal Cancer|Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779040|NCT02001623|FG012|Participant Flow|Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779041|NCT02001623|FG013|Participant Flow|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779042|NCT02001623|FG014|Participant Flow|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779043|NCT02001623|OG000|Outcome|Dose Escalation Part: 0.3 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
10779044|NCT02001623|OG001|Outcome|Dose Escalation Part: 0.6 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
10779045|NCT02001623|OG002|Outcome|Dose Escalation Part: 0.9 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
10779046|NCT02001623|OG003|Outcome|Dose Escalation Part: 1.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
10779047|NCT02001623|OG004|Outcome|Dose Escalation Part: 1.5 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
10779048|NCT02001623|OG005|Outcome|Dose Escalation Part: 1.8 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
10779049|NCT02001623|OG006|Outcome|Dose Escalation Part: 2.0 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779050|NCT02001623|OG007|Outcome|Dose Escalation Part: 2.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
10779051|NCT02001623|OG008|Outcome|Dose Expansion Part: Bladder Cancer|Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779052|NCT02001623|OG009|Outcome|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779053|NCT02001623|OG010|Outcome|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779054|NCT02001623|OG011|Outcome|Dose Expansion Part: Esophageal Cancer|Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779055|NCT02001623|OG012|Outcome|Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779056|NCT02001623|OG013|Outcome|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779057|NCT02001623|OG014|Outcome|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779058|NCT02001623|OG008|Outcome|Dose Expansion Part: Pharmacokinetics (PK) Analysis Set|PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
10779059|NCT02001623|OG008|Outcome|Dose Expansion Part: Pharmacokinetics (PK) Analysis Set|PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study
10779060|NCT02001623|OG000|Outcome|Dose Expansion Part: Bladder Cancer|Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779061|NCT02001623|OG001|Outcome|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779062|NCT02001623|OG002|Outcome|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779063|NCT02001623|OG003|Outcome|Dose Expansion Part: Esophageal Cancer|Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779064|NCT02001623|OG004|Outcome|Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779065|NCT02001623|OG005|Outcome|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779066|NCT02001623|OG006|Outcome|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779067|NCT02001623|OG008|Outcome|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779068|NCT02001623|OG008|Outcome|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0mg/kg of body weight.
10779069|NCT02001623|OG009|Outcome|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779070|NCT02001623|OG010|Outcome|Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779071|NCT02001623|OG011|Outcome|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779072|NCT02001623|OG000|Outcome|Dose Escalation Part: 0.3 mg/kg|Dose Escalation Part: 0.3 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
10779073|NCT02001623|OG001|Outcome|Dose Escalation Part: 0.6 mg/kg|Dose Escalation Part: 0.6 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
10779074|NCT02001623|OG002|Outcome|Dose Escalation Part: 0.9 mg/kg|Dose Escalation Part: 0.9 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
10779075|NCT02001623|EG000|Reported Event|Dose Escalation Part: 0.3 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
10779076|NCT02001623|EG001|Reported Event|Dose Escalation Part: 0.6 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
10779077|NCT02001623|EG002|Reported Event|Dose Escalation Part: 0.9 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
10779078|NCT02001623|EG003|Reported Event|Dose Escalation Part: 1.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
10779079|NCT02001623|EG004|Reported Event|Dose Escalation Part: 1.5 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
10779080|NCT02001623|EG005|Reported Event|Dose Escalation Part: 1.8 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
10779081|NCT02001623|EG006|Reported Event|Dose Escalation Part: 2.0 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779082|NCT02001623|EG007|Reported Event|Dose Escalation Part: 2.2 mg/kg|Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
10779083|NCT02001623|EG008|Reported Event|Dose Expansion Part: Bladder Cancer|Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779084|NCT02001623|EG009|Reported Event|Dose Expansion Part: Cervical Cancer|Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779085|NCT02001623|EG010|Reported Event|Dose Expansion Part: Endometrial Cancer|Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779086|NCT02001623|EG011|Reported Event|Dose Expansion Part: Esophageal Cancer|Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779087|NCT02001623|EG012|Reported Event|Dose Expansion Part: Non-Small-Cell Lung Cancer|Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779088|NCT02001623|EG013|Reported Event|Dose Expansion Part: Ovarian Cancer|Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779089|NCT02001623|EG014|Reported Event|Dose Expansion Part: Prostate Cancer|Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
10779090|NCT01900002|BG000|Baseline|Treatment (Sorafenib Tosylate, TheraSphere)|Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10779091|NCT01900002|FG000|Participant Flow|Treatment (Sorafenib Tosylate, TheraSphere)|Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10779092|NCT01900002|OG000|Outcome|Treatment (Sorafenib Tosylate, TheraSphere)|Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10779093|NCT01900002|EG000|Reported Event|Treatment (Sorafenib Tosylate, TheraSphere)|Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10779094|NCT01595061|BG000|Baseline|GEM+CIS+IMRT|Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
10779095|NCT01595061|FG000|Participant Flow|GEM+CIS+IMRT|Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
10779096|NCT01595061|OG000|Outcome|GEM+CIS+IMRT|Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
10779097|NCT01595061|EG000|Reported Event|GEM+CIS+IMRT|Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
10801091|NCT02573493|FG001|Participant Flow|Arm 2: Nab-Paclitaxel (A) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment~If CR/PR, three more weeks of nab-paclitaxel followed by CRT~If <PR, move directly to CRT if not surgical candidates.~CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.~It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801092|NCT02573493|FG002|Participant Flow|Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab~CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801093|NCT02573493|FG003|Participant Flow|Not Enrolled in Any Arm|-Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
10801094|NCT02573493|OG000|Outcome|Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates.~CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801095|NCT02573493|OG001|Outcome|Arm 2: Nab-Paclitaxel (A) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment~If CR/PR, three more weeks of nab-paclitaxel followed by CRT~If <PR, move directly to CRT if not surgical candidates.~CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.~It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
11193391|NCT02144610|FG000|Participant Flow|Gene Therapy HGF Plasmid (AMG0001)|"Randomized subjects will receive 4 sets of intramuscular (IM) injections of hepatocyte growth factor (HGF) plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb, for a total of 16 sets of IM injections.~Each set will be 8 IM injections; each IM injection contains 3 mL AMG0001.~HGF Plasmid (AMG0001): IM"
10779098|NCT04502212|BG000|Baseline|Ultrasound Insonification Effect Population|"The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and completed the study for all outcomes (without being discontinued from the study at the discretion of the Investigator or failing to complete the clamp outcomes due to protocol deviation) and included 14 subjects.~The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects."
10779099|NCT04502212|FG000|Participant Flow|Ultrasound Insonification Effect Population|"The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 14 subjects.~The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects.~One subject had unevaluable data and was excluded from the Ultrasound Insonification Effect Population; however, the subject was included in the Safety Population.~One subject had Step 1 of the Day 17 clamp extended by 60 minutes, per PI discretion, following a protocol deviation and was excluded from the Ultrasound Insonification Effect Population; however, the subject was included in the Safety Population."
10779100|NCT04502212|OG000|Outcome|Ultrasound Insonification Effect Population|"The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 14 subjects.~The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects."
10779101|NCT04502212|OG000|Outcome|Safety Population|"The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects.~The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 14 subjects."
10779102|NCT04502212|EG000|Reported Event|Safety Population|The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects (44.4%).
10779103|NCT04442230|BG000|Baseline|NasoVAX|"Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).~NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension"
10779104|NCT04442230|BG001|Baseline|Placebo|"Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).~Placebo: Normal saline"
10779105|NCT04442230|BG002|Baseline|Total|Total of all reporting groups
10779106|NCT04442230|FG000|Participant Flow|NasoVAX|"Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).~NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension"
10779107|NCT04442230|FG001|Participant Flow|Placebo|"Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).~Placebo: Normal saline"
10779108|NCT04442230|OG000|Outcome|NasoVAX|"Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).~NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension"
10779109|NCT04442230|OG001|Outcome|Placebo|"Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).~Placebo: Normal saline"
10779110|NCT04442230|EG000|Reported Event|NasoVAX|"Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).~NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension"
10779111|NCT04442230|EG001|Reported Event|Placebo|"Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).~Placebo: Normal saline"
10779112|NCT04794803|BG000|Baseline|Reparixin (FAS)|"Reparixin oral tablets 1200 mg TID for 7 days~Reparixin: Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first."
10779113|NCT04794803|BG001|Baseline|Standard of Care (FAS)|"Standard of care~Standard of care: Standard of care"
11193392|NCT02144610|FG001|Participant Flow|Placebo|"Randomized subjects will receive 4 sets of intramuscular (IM) injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb, for a total of 16 sets of IM injections.~Each set will be 8 IM injections; each IM injection contains 3 mL placebo.~Matching Placebo: IM"
11193393|NCT02144610|OG000|Outcome|Gene Therapy HGF Plasmid (AMG0001)|"Randomized subjects will receive 4 sets of intramuscular injections of HGF plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~HGF Plasmid (AMG0001): IM"
10779114|NCT04794803|BG002|Baseline|Total|Total of all reporting groups
10779115|NCT04794803|FG000|Participant Flow|Reparixin|"Reparixin oral tablets 1200 mg TID for 7 days~Reparixin: Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first."
10779116|NCT04794803|FG001|Participant Flow|Standard of Care|"Standard of care~Standard of care: Standard of care"
10779117|NCT04794803|OG000|Outcome|Reparixin (FAS)|"Reparixin oral tablets 1200 mg TID for 7 days~Reparixin: Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first."
10779118|NCT04794803|OG001|Outcome|Standard of Care (FAS)|"Standard of care~Standard of care: Standard of care"
10779119|NCT04794803|EG000|Reported Event|Reparixin (SAF)|Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first.
10779120|NCT04794803|EG001|Reported Event|Standard of Care (SAF)|Standard of care, which is defined as any drug currently used to treat the COVID-19 pneumonia.
11193394|NCT02144610|OG001|Outcome|Placebo|"Randomized subjects will receive 4 sets of intramuscular injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~Matching Placebo: IM"
11379027|NCT04020718|BG000|Baseline|Early Assessment|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379028|NCT04020718|BG001|Baseline|Late Assessment|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379029|NCT04020718|BG002|Baseline|Total|Total of all reporting groups
11379030|NCT04020718|FG000|Participant Flow|Early Assessment|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379031|NCT04020718|FG001|Participant Flow|Late Assessment|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379032|NCT04020718|FG002|Participant Flow|Early Assessment Non-responders NRT|Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching
11379033|NCT04020718|FG003|Participant Flow|Early Assessment Non-responders NRT Plus Coaching|Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching
11379034|NCT04020718|FG004|Participant Flow|Late Assessment Non-responders NRT|Individuals reporting past 7 day smoking at 8 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching
11379035|NCT04020718|FG005|Participant Flow|Late Assessment Non-responders NRT Plus Coaching|Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching
11379036|NCT04020718|FG006|Participant Flow|Early Assessment Responders|Individuals reporting past 7 day abstinence from cigarettes at 4 weeks post-enrollment, assigned to continue text messages
11379037|NCT04020718|FG007|Participant Flow|Late Assessment Responders|Individuals reporting past 7 day abstinence from cigarettes at 8 weeks post-enrollment, assigned to continue text messages
10779121|NCT04706403|BG000|Baseline|Message 1|"Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation (What do you think?)"
10779122|NCT04706403|BG001|Baseline|Message 2|"Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation (I recommend that you get it)."
10779123|NCT04706403|BG002|Baseline|Message 3|"Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation (I recommend that you get it)."
10779124|NCT04706403|BG003|Baseline|Message 4|"Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgement of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation (I recommend that you get it)."
10779125|NCT04706403|BG004|Baseline|Message 5|"Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation (I recommend that you get it)."
10779126|NCT04706403|BG005|Baseline|Total|Total of all reporting groups
10779127|NCT04706403|FG000|Participant Flow|Message 1|"Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation (What do you think?)"
10779128|NCT04706403|FG001|Participant Flow|Message 2|"Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation (I recommend that you get it)."
10779129|NCT04706403|FG002|Participant Flow|Message 3|"Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation (I recommend that you get it)."
10779130|NCT04706403|FG003|Participant Flow|Message 4|"Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation (I recommend that you get it)."
10779131|NCT04706403|FG004|Participant Flow|Message 5|"Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation (I recommend that you get it)."
10779132|NCT04706403|OG000|Outcome|Message 1|"Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation (What do you think?)"
10779133|NCT04706403|OG001|Outcome|Message 2|"Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation (I recommend that you get it)."
10779134|NCT04706403|OG002|Outcome|Message 3|"Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation (I recommend that you get it)."
10779135|NCT04706403|OG003|Outcome|Message 4|"Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation (I recommend that you get it)."
10779136|NCT04706403|OG004|Outcome|Message 5|"Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation (I recommend that you get it)."
10779137|NCT04706403|EG000|Reported Event|Message 1|"Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation (What do you think?)"
10779138|NCT04706403|EG001|Reported Event|Message 2|"Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation (I recommend that you get it)."
10779139|NCT04706403|EG002|Reported Event|Message 3|"Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation (I recommend that you get it)."
10779140|NCT04706403|EG003|Reported Event|Message 4|"Participants were be randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation (I recommend that you get it)."
10779141|NCT04706403|EG004|Reported Event|Message 5|"Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation (I recommend that you get it)."
10801096|NCT02573493|OG002|Outcome|Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab~CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801097|NCT02573493|OG000|Outcome|Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates.~CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801098|NCT02573493|OG000|Outcome|Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates."
10801099|NCT02573493|OG001|Outcome|Arm 2: Nab-Paclitaxel (A) Induction|"Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment~If CR/PR, three more weeks of nab-paclitaxel followed by CRT~If <PR, move directly to CRT if not surgical candidates."
11193395|NCT02144610|EG000|Reported Event|Gene Therapy HGF Plasmid (AMG0001)|"Randomized subjects will receive 4 sets of intramuscular injections of HGF plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~HGF Plasmid (AMG0001): IM"
11193396|NCT02144610|EG001|Reported Event|Placebo|"Randomized subjects will receive 4 sets of intramuscular injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb.~Matching Placebo: IM"
11193397|NCT02144675|BG000|Baseline|Arm I (Choline Magnesium Trisalicylate and Chemotherapy)|"Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.~choline magnesium trisalicylate: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
10801100|NCT02573493|OG002|Outcome|Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT"
11193398|NCT02144675|BG001|Baseline|Arm II (Chemotherapy)|"Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193399|NCT02144675|BG002|Baseline|Total|Total of all reporting groups
11193400|NCT02144675|FG000|Participant Flow|Arm I (Choline Magnesium Trisalicylate and Chemotherapy)|"Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.~choline magnesium trisalicylate: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193401|NCT02144675|FG001|Participant Flow|Arm II (Chemotherapy)|"Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193402|NCT02144675|OG000|Outcome|Arm I (Choline Magnesium Trisalicylate and Chemotherapy)|"Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.~choline magnesium trisalicylate: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193403|NCT02144675|OG001|Outcome|Arm II (Chemotherapy)|"Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193404|NCT02144675|EG000|Reported Event|Arm I (Choline Magnesium Trisalicylate and Chemotherapy)|"Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.~choline magnesium trisalicylate: Given PO~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
10779142|NCT04440449|BG000|Baseline|Behavioral Lifestyle Intervention|"This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.~Lifestyle App: A mobile app used to assist with lifestyle changes"
10779143|NCT04440449|BG001|Baseline|Group B - Control Group|The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
10779144|NCT04440449|BG002|Baseline|Total|Total of all reporting groups
10779145|NCT04440449|FG000|Participant Flow|Behavioral Lifestyle Intervention|"This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.~Lifestyle App: A mobile app used to assist with lifestyle changes"
10779146|NCT04440449|FG001|Participant Flow|Group B - Control Group|The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
10779147|NCT04440449|OG000|Outcome|Behavioral Lifestyle Intervention|"The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.~Lifestyle App: A mobile app used to assist with lifestyle changes"
10779148|NCT04440449|OG001|Outcome|Group B - Control Group|The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
10779149|NCT04440449|OG001|Outcome|Group B -Control Group|The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months)
10779150|NCT04440449|OG000|Outcome|Behavioral Lifestyle Intervention|"This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.~Lifestyle App: A mobile app used to assist with lifestyle changes"
10779151|NCT04440449|EG000|Reported Event|Behavioral Lifestyle Intervention|"This group will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.~Lifestyle App: A mobile app used to assist with lifestyle changes"
10779152|NCT04369469|BG000|Baseline|Group 1 - Ravulizumab + BSC|Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.
11193405|NCT02144675|EG001|Reported Event|Arm II (Chemotherapy)|"Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.~idarubicin: Given IV~cytarabine: Given IV~laboratory biomarker analysis: Correlative studies"
11193406|NCT02144701|BG000|Baseline|Arm I (Lactobacillus Rhamnosus GG)|"Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.~Lactobacillus rhamnosus GG: Given PO~laboratory biomarker analysis: Correlative studies"
10779153|NCT04369469|BG001|Baseline|Group 2 - BSC Alone|Participants received medications, therapies, and interventions per standard hospital treatment protocols
10779154|NCT04369469|BG002|Baseline|Total|Total of all reporting groups
10779155|NCT04369469|FG000|Participant Flow|Group 1 - Ravulizumab + BSC|Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.
10779156|NCT04369469|FG001|Participant Flow|Group 2 - BSC Alone|Participants received medications, therapies, and interventions per standard hospital treatment protocols
10779157|NCT04369469|OG000|Outcome|Group 1 - Ravulizumab + BSC|Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.
10779158|NCT04369469|OG001|Outcome|Group 2 - BSC Alone|Participants received medications, therapies, and interventions per standard hospital treatment protocols.
10779159|NCT04369469|EG000|Reported Event|Group 1 - Ravulizumab + BSC|Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.
10779160|NCT04369469|EG001|Reported Event|Group 2 - BSC Alone|Participants received medications, therapies, and interventions per standard hospital treatment protocols.
10803663|NCT02846532|OG001|Outcome|Rivaroxaban (Part B)|Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
11193407|NCT02144701|BG001|Baseline|Arm II (no Intervention)|Patients receive no intervention.
11193408|NCT02144701|BG002|Baseline|Total|Total of all reporting groups
11193409|NCT02144701|FG000|Participant Flow|Lactobacillus Rhamnosus GG|"Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.~Lactobacillus rhamnosus GG: Given PO~laboratory biomarker analysis: Correlative studies"
11193410|NCT02144701|FG001|Participant Flow|no Intervention|Patients receive no intervention.
11193411|NCT02144701|OG000|Outcome|Arm I (Lactobacillus Rhamnosus GG)|"Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.~Lactobacillus rhamnosus GG: Given PO~laboratory biomarker analysis: Correlative studies"
10964406|NCT00877058|EG001|Reported Event|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
10964407|NCT00877058|EG002|Reported Event|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
11193412|NCT02144701|OG001|Outcome|Arm II (no Intervention)|Patients receive no intervention.
11193413|NCT02144701|EG000|Reported Event|Arm I (Lactobacillus Rhamnosus GG)|"Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.~Lactobacillus rhamnosus GG: Given PO~laboratory biomarker analysis: Correlative studies"
11193414|NCT02144701|EG001|Reported Event|Arm II (no Intervention)|Patients receive no intervention.
11193415|NCT02144714|BG000|Baseline|SB5 (Proposed Adalimumab Biosimilar)|"SB5, single dose of 40 mg via subcutaneous injection (study drug)~SB5~EU sourced Humira®"
10779170|NCT04036799|BG000|Baseline|Hypertrophic Cardiomyopathy|Patients included were those with a clinical diagnosis of HCM defined as having LV posterior wall or septal thickness z score ≥2, age <18 years at the time of diagnosis, absence of a SCD event before diagnosis, and at least 1 follow-up assessment after diagnosis.
10779171|NCT04036799|FG000|Participant Flow|Hypertrophic Cardiomyopathy|Patients with a clinical diagnosis of HCM defined as having an LV posterior wall or septal thickness z score ≥2.
10779172|NCT04036799|OG000|Outcome|Hypertrophic Cardiomyopathy|Phenotype-positive HCM diagnosed between 1987 and 2018
10779173|NCT04036799|EG000|Reported Event|Hypertrophic Cardiomyopathy|Patients with a clinical diagnosis of HCM defined as having an LV posterior wall or septal thickness z score ≥2.
10779174|NCT03965962|BG000|Baseline|Group 1 VRVg-2+HRIG|Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) single injection at Day 0.
10779175|NCT03965962|BG001|Baseline|Group 2 Verorab+HRIG|Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779176|NCT03965962|BG002|Baseline|Group 3 Imovax Rabies+HRIG|Participants received 0.5 mL IM injection of Imovax on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779177|NCT03965962|BG003|Baseline|Group 4 VRVg-2|Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
10779178|NCT03965962|BG004|Baseline|Total Title|
10779179|NCT03965962|FG000|Participant Flow|Group 1 VRVg-2+HRIG|Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) single injection at Day 0.
10779180|NCT03965962|FG001|Participant Flow|Group 2 Verorab+HRIG|Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779181|NCT03965962|FG002|Participant Flow|Group 3 Imovax Rabies+HRIG|Participants received 0.5 mL IM injection of Imovax on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779182|NCT03965962|FG003|Participant Flow|Group 4 VRVg-2|Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
10779183|NCT03965962|OG000|Outcome|Group 1 VRVg-2+HRIG|Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) single injection at Day 0.
10779184|NCT03965962|OG001|Outcome|Group 2 Verorab+HRIG|Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779185|NCT03965962|OG002|Outcome|Group 3 Imovax Rabies+HRIG|Participants received 0.5 mL IM injection of Imovax on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779186|NCT03965962|OG003|Outcome|Group 4 VRVg-2|Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
10779187|NCT03965962|EG000|Reported Event|Group 1 VRVg-2+HRIG|Participants received 0.5 milliliters (mL) intramuscular (IM) injection of Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) formulation on Days 0, 3, 7, 14 and 28 along with Human Rabies Immunoglobulins (HRIG) single injection at Day 0.
10779188|NCT03965962|EG001|Reported Event|Group 2 Verorab+HRIG|Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779189|NCT03965962|EG002|Reported Event|Group 3 Imovax Rabies+HRIG|Participants received 0.5 mL IM injection of Imovax on Days 0, 3, 7, 14 and 28 along with HRIG single injection at Day 0.
10779190|NCT03965962|EG003|Reported Event|Group 4 VRVg-2|Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
10779191|NCT03772574|BG000|Baseline|Standard Facemask|"Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).~Facemask preoxygenation: Standard facemask preoxygenation"
10779192|NCT03772574|BG001|Baseline|THRIVE|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779193|NCT03772574|BG002|Baseline|THRIVE and Facemask|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779194|NCT03772574|BG003|Baseline|Total|Total of all reporting groups
10779195|NCT03772574|FG000|Participant Flow|Standard Facemask|"Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).~Facemask preoxygenation: Standard facemask preoxygenation"
10779196|NCT03772574|FG001|Participant Flow|THRIVE|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779197|NCT03772574|FG002|Participant Flow|THRIVE and Facemask|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779198|NCT03772574|OG000|Outcome|Standard Facemask|"Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).~Facemask preoxygenation: Standard facemask preoxygenation"
10779199|NCT03772574|OG001|Outcome|THRIVE|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779200|NCT03772574|OG002|Outcome|THRIVE and Facemask|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779201|NCT03772574|EG000|Reported Event|Standard Facemask|"Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).~Facemask preoxygenation: Standard facemask preoxygenation"
10779202|NCT03772574|EG001|Reported Event|THRIVE|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779203|NCT03772574|EG002|Reported Event|THRIVE and Facemask|"THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment~THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
10779204|NCT03694522|BG000|Baseline|Bemarituzumab + mFOLFOX6|Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10779205|NCT03694522|BG001|Baseline|Placebo + mFOLFOX6|Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10779206|NCT03694522|BG002|Baseline|Total|Total of all reporting groups
10779207|NCT03694522|FG000|Participant Flow|Bemarituzumab + mFOLFOX6|Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received modified FOLFOX (mFOLFOX6) chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10779208|NCT03694522|FG001|Participant Flow|Placebo + mFOLFOX6|Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10779209|NCT03694522|OG000|Outcome|Bemarituzumab + mFOLFOX6|Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10779210|NCT03694522|OG001|Outcome|Placebo + mFOLFOX6|Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
11193416|NCT02144714|BG001|Baseline|EU Sourced Humira®|"EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~SB5~US sourced Humira®"
10779211|NCT03694522|EG000|Reported Event|Bemarituzumab + mFOLFOX6|Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
11193417|NCT02144714|BG002|Baseline|US Sourced Humira®|"US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~EU sourced Humira®~US sourced Humira®"
10779212|NCT03694522|EG001|Reported Event|Placebo + mFOLFOX6|Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
10803664|NCT02846532|OG002|Outcome|Aspirin (Part B)|Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
10850570|NCT00303472|BG005|Baseline|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
11193418|NCT02144714|BG003|Baseline|Total|Total of all reporting groups
11193419|NCT02144714|FG000|Participant Flow|SB5 (Proposed Adalimumab Biosimilar)|"SB5, single dose of 40 mg via subcutaneous injection (study drug)~SB5~EU sourced Humira®"
11193420|NCT02144714|FG001|Participant Flow|EU Sourced Humira®|"EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~SB5~US sourced Humira®"
11193421|NCT02144714|FG002|Participant Flow|US Sourced Humira®|"US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~EU sourced Humira®~US sourced Humira®"
11193422|NCT02144714|OG000|Outcome|SB5 (Proposed Adalimumab Biosimilar)|"SB5, single dose of 40 mg via subcutaneous injection (study drug)~SB5~EU sourced Humira®"
10779222|NCT03594955|BG000|Baseline|SAR440234|SAR440234 was administered as intravenous (IV) infusion once weekly for 6 weeks per Cycle. Per plan, participants were to receive first 2 to 3 doses as Lead-in doses followed by a fixed dose until the end of treatment or unless the dose needs to be decreased for safety reasons. Due to early study termination, all participants received only 1 treatment cycle at a dose of 1 nanogram per kilogram (ng/kg) once weekly.
10779223|NCT03594955|FG000|Participant Flow|SAR440234|SAR440234 was administered as intravenous (IV) infusion once weekly for 6 weeks per Cycle. Per plan, participants were to receive first 2 to 3 doses as Lead-in doses followed by a fixed dose until the end of treatment or unless the dose needs to be decreased for safety reasons. Due to early study termination, all participants received only 1 treatment cycle at a dose of 1 nanogram per kilogram (ng/kg) once weekly.
10779224|NCT03594955|OG000|Outcome|SAR440234|SAR440234 was administered as intravenous (IV) infusion once weekly for 6 weeks per Cycle. Per plan, participants were to receive first 2 to 3 doses as Lead-in doses followed by a fixed dose until the end of treatment or unless the dose needs to be decreased for safety reasons. Due to early study termination, all participants received only 1 treatment cycle at a dose of 1 nanogram per kilogram (ng/kg) once weekly.
10779225|NCT03594955|EG000|Reported Event|SAR440234|SAR440234 was administered as intravenous (IV) infusion once weekly for 6 weeks per Cycle. Per plan, participants were to receive first 2 to 3 doses as Lead-in doses followed by a fixed dose until the end of treatment or unless the dose needs to be decreased for safety reasons. Due to early study termination, all participants received only 1 treatment cycle at a dose of 1 nanogram per kilogram (ng/kg) once weekly.
10779226|NCT03548220|BG000|Baseline|Placebo Comparator: Placebo|Participants received a matching placebo to AG-348 tablets, for a period of 12 weeks as an optimized dose. This was followed by matching placebo further, for a period of 12 weeks as a fixed-dose.
10779227|NCT03548220|BG001|Baseline|Experimental: AG-348, 5 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779228|NCT03548220|BG002|Baseline|Experimental: AG-348, 20 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10850571|NCT00303472|BG006|Baseline|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
10850572|NCT00303472|BG007|Baseline|Total|Total of all reporting groups
10850573|NCT00303472|FG000|Participant Flow|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850574|NCT00303472|FG001|Participant Flow|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850575|NCT00303472|FG002|Participant Flow|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850576|NCT00303472|FG003|Participant Flow|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850577|NCT00303472|FG004|Participant Flow|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850578|NCT00303472|FG005|Participant Flow|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
10850579|NCT00303472|FG006|Participant Flow|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
10850580|NCT00303472|OG000|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850581|NCT00303472|OG001|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850582|NCT00303472|OG002|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850583|NCT00303472|OG003|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850584|NCT00303472|OG000|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
11193423|NCT02144714|OG001|Outcome|EU Sourced Humira®|"EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~SB5~US sourced Humira®"
11193424|NCT02144714|OG002|Outcome|US Sourced Humira®|"US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~EU sourced Humira®~US sourced Humira®"
11193425|NCT02144714|EG000|Reported Event|SB5 (Proposed Adalimumab Biosimilar)|"SB5, single dose of 40 mg via subcutaneous injection (study drug)~SB5~EU sourced Humira®"
11193426|NCT02144714|EG001|Reported Event|EU Sourced Humira®|"EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~SB5~US sourced Humira®"
11193427|NCT02144714|EG002|Reported Event|US Sourced Humira®|"US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)~EU sourced Humira®~US sourced Humira®"
11193428|NCT02145026|BG000|Baseline|Epoetin Beta|Participants received epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Initial response was evaluated at Week 4 and the subsequent dose was based on response: for hemoglobin levels >/= 12 grams per deciliter (g/dL), epoetin beta was discontinued until levels were </= 10 g/dL; for hemoglobin levels <12 g/dL and that increased less than 1 g/dL, 60,000 IU of epoetin beta were administered until Week 12; and for hemoglobin levels <12 g/dL and that increased >/= 1 g/dL, 30,000 IU of epoetin beta were administered until Week 12.
11193429|NCT02145026|FG000|Participant Flow|Epoetin Beta|Participants received epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Initial response was evaluated at Week 4 and the subsequent dose was based on response: for hemoglobin levels >/= 12 grams per deciliter (g/dL), epoetin beta was discontinued until levels were </= 10 g/dL; for hemoglobin levels <12 g/dL and that increased less than 1 g/dL, 60,000 IU of epoetin beta were administered until Week 12; and for hemoglobin levels <12 g/dL and that increased >/= 1 g/dL, 30,000 IU of epoetin beta were administered until Week 12.
11193430|NCT02145026|OG000|Outcome|Epoetin Beta|Participants received epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Initial response was evaluated at Week 4 and the subsequent dose was based on response: for hemoglobin levels >/= 12 grams per deciliter (g/dL), epoetin beta was discontinued until levels were </= 10 g/dL; for hemoglobin levels <12 g/dL and that increased less than 1 g/dL, 60,000 IU of epoetin beta were administered until Week 12; and for hemoglobin levels <12 g/dL and that increased >/= 1 g/dL, 30,000 IU of epoetin beta were administered until Week 12.
11193431|NCT02145026|EG000|Reported Event|Epoetin Beta|Participants received epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Initial response was evaluated at Week 4 and the subsequent dose was based on response: for hemoglobin levels >/= 12 grams per deciliter (g/dL), epoetin beta was discontinued until levels were </= 10 g/dL; for hemoglobin levels <12 g/dL and that increased less than 1 g/dL, 60,000 IU of epoetin beta were administered until Week 12; and for hemoglobin levels <12 g/dL and that increased >/= 1 g/dL, 30,000 IU of epoetin beta were administered until Week 12.
11202203|NCT02206061|BG000|Baseline|School-Based Asthma Care for Teens (SB-ACT)|"SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.~The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.~School-Based Asthma Care for Teens (SB-ACT)"
11202204|NCT02206061|BG001|Baseline|Directly Observed Therapy|"For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).~Directly Observed Therapy"
11202205|NCT02206061|BG002|Baseline|Asthma Education|"Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.~Asthma Education"
11202206|NCT02206061|BG003|Baseline|Total|Total of all reporting groups
11202207|NCT02206061|FG000|Participant Flow|School-Based Asthma Care for Teens (SB-ACT)|"SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.~The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.~School-Based Asthma Care for Teens (SB-ACT)"
11202208|NCT02206061|FG001|Participant Flow|Directly Observed Therapy|"For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).~Directly Observed Therapy"
11202209|NCT02206061|FG002|Participant Flow|Asthma Education|"Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.~Asthma Education"
11240940|NCT02482870|EG001|Reported Event|Macintosh First, Then King Vision|These patients had been intubated with a Macintosh laryngoscope first, and then with a King Vision video laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
11240941|NCT02482935|BG000|Baseline|Abemaciclib|200 mg abemaciclib administered once orally in each of two study periods.
11240942|NCT02482935|FG000|Participant Flow|Abemaciclib Fasted/Fed|200 milligrams (mg) abemaciclib administered orally, once in a fasted state, then once in a fed state.
11240943|NCT02482935|FG001|Participant Flow|Abemaciclib Fed/Fasted|200 mg abemaciclib administered orally, once in a fed state, then once in a fasted state.
11240944|NCT02482935|OG000|Outcome|Abemaciclib Fasted|200 mg abemaciclib administered once, orally, in a fasted state.
11240945|NCT02482935|OG001|Outcome|Abemaciclib Fed|200 mg abemaciclib administered once, orally, in a fed state.
11240946|NCT02482935|EG000|Reported Event|Abemaciclib Fasted|200 mg abemaciclib administered once, orally, in a fasted state.
11240947|NCT02482935|EG001|Reported Event|Abemaciclib Fed|200 mg abemaciclib administered once, orally, in a fed state.
11240948|NCT02483000|BG000|Baseline|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.~Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT"
11240949|NCT02483000|FG000|Participant Flow|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.~Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT"
11240950|NCT02483000|OG000|Outcome|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.~Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT"
11240951|NCT02483000|OG000|Outcome|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.~Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein: Given IV"
11240952|NCT02483000|OG000|Outcome|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care."
11240953|NCT02483000|OG000|Outcome|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2."
11240954|NCT02483000|EG000|Reported Event|Treatment (PRIT)|"B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.~CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.~RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.~BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.~STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.~Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein: Given IV~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT"
11240955|NCT02483416|BG000|Baseline|Group With Nurse-led Telephone Follow-up|Group with remote additional personalised nurse-led follow-up: patients received telephone calls from a nurse in addition to the healthcare given routinely by their medical team
11240956|NCT02483416|BG001|Baseline|Group Without Nurse-led Telephone Follow-up|Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
11240957|NCT02483416|BG002|Baseline|Total|Total of all reporting groups
10779229|NCT03548220|BG003|Baseline|Experimental: AG-348, 50 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779230|NCT03548220|BG004|Baseline|Total|Total of all reporting groups
10779231|NCT03548220|FG000|Participant Flow|Placebo Comparator: Placebo|Participants received a matching placebo to AG-348 tablets, for a period of 12 weeks as an optimized dose. This was followed by matching placebo further, for a period of 12 weeks as a fixed-dose.
10779232|NCT03548220|FG001|Participant Flow|Experimental: AG-348 5 mg|Participants received AG-348 tablets, 5 milligrams (mg) twice daily (BID), administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779233|NCT03548220|FG002|Participant Flow|Experimental: AG-348, 20 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779234|NCT03548220|FG003|Participant Flow|Experimental: AG-348, 50 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779235|NCT03548220|OG000|Outcome|Placebo Comparator: Placebo|Participants received matching placebo to AG-348 tablets, for a period of 12 weeks as an optimized dose. This was followed by matching placebo further, for a period of 12 weeks as a fixed-dose.
10779236|NCT03548220|OG001|Outcome|Experimental: AG-348|Participants received AG-348 tablets, 5 mg for 4 weeks followed by the respective optimized dose of 5 mg or 20 mg or 50 mg BID as determined by the investigator, administered orally, up to Weeks 8 and 12 respectively, as an optimized dose and continued to receive the same dose for a period of 12 weeks as a fixed-dose.
10779237|NCT03548220|OG000|Outcome|Placebo Comparator: Placebo|Participants received matching placebo to AG-348 tablets, for a period of 12 weeks as an optimized dose. This was followed by matching placebo further, for a period of 12 weeks as a fixed dose.
10779238|NCT03548220|OG001|Outcome|Experimental: AG-348 5 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose
10779239|NCT03548220|OG002|Outcome|Experimental: AG-348 20 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779240|NCT03548220|OG003|Outcome|Experimental: AG-348 50 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779241|NCT03548220|OG000|Outcome|AG-348, 5mg|Participants received 5mg AG-348 tablets BID at Week 12.
10779242|NCT03548220|OG001|Outcome|AG-348, 20 mg|Participants received 20mg AG-348 tablets BID at Week 12.
10779243|NCT03548220|OG002|Outcome|AG-348, 50mg|Participants received 50mg AG-348 tablets BID at Week 12.
10779244|NCT03548220|OG001|Outcome|AG-348, 20mg|Participants received 20mg AG-348 tablets BID at Week 12.
10779245|NCT03548220|OG002|Outcome|AG-346, 50mg|Participants received 50mg AG-348 tablets BID at Week 12.
10779246|NCT03548220|OG000|Outcome|Experimental: AG-348 5 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, participants continued to receive the same dose as determined by the investigator based on safety and efficacy up to Week 12, followed by the same optimized dose of 5 mg BID, for a period of 12 weeks as a fixed-dose.
10779247|NCT03548220|OG001|Outcome|Experimental: AG-348 20 mg|Participants received AG-348 tablets, starting dose of 5 mg BID for 4 weeks, the dose was uptitrated to 20 mg BID, administered orally, up to Week 12 as an optimized dose as determined by the investigator based on safety and efficacy, followed by the same optimized dose of 20 mg BID further for a period of 12 weeks as a fixed-dose.
10779248|NCT03548220|OG002|Outcome|Experimental: AG-348 50 mg|Participants received AG-348 tablets, starting dose of 5 mg BID for 4 weeks, the dose was uptitrated to 20 mg BID, administered orally, up to Week 8 followed by dose up titration to 50 mg BID up to Week 12 as an optimized dose, followed by the same optimized dose of 50 mg BID, as determined by the investigator based on safety and efficacy, further for a period of 12 weeks as a fixed-dose.
11193432|NCT02145039|BG000|Baseline|Haploidentical Stem Cell Transplant|"This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).~Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.~Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.~Total Body Irradiation: TBI 200cGy on day -1 before transplant.~Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion"
10779249|NCT03548220|EG000|Reported Event|Placebo Comparator: Placebo|Participants received a matching placebo to AG-348 tablets, for a period of 12 weeks as an optimized dose. This was followed by matching placebo further, for a period of 12 weeks as a fixed-dose.
10779250|NCT03548220|EG001|Reported Event|Experimental: AG-348, 5 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 5 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779251|NCT03548220|EG002|Reported Event|Experimental: AG-348, 20 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 20 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779252|NCT03548220|EG003|Reported Event|Experimental: AG-348, 50 mg|Participants received AG-348 tablets, 5 mg BID, administered orally, for 4 weeks as a starting dose, followed by two potential sequential dose level increases to 20 mg and 50 mg BID at Weeks 4 and 8 respectively as determined by the investigator based on safety and efficacy. The optimized dose for each participant was determined as 50 mg BID at Week 12, and participants then received that optimized dose for a period of 12 weeks as a fixed dose.
10779262|NCT03453684|BG000|Baseline|Administration of Vancomycin|"Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision~Administration of Vancomycin: Intravenous Vancomycin Administration"
10779263|NCT03453684|FG000|Participant Flow|Administration of Vancomycin|"Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision~Administration of Vancomycin: Intravenous Vancomycin Administration"
10779264|NCT03453684|OG000|Outcome|Administration of Vancomycin|"Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision~Administration of Vancomycin: Intravenous Vancomycin Administration"
10779265|NCT03453684|EG000|Reported Event|Administration of Vancomycin|"Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision~Administration of Vancomycin: Intravenous Vancomycin Administration"
10803665|NCT02846532|EG000|Reported Event|Rivaroxaban (Part A)|Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
10803666|NCT02846532|EG001|Reported Event|Rivaroxaban (Part B)|Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.
10803667|NCT02846532|EG002|Reported Event|Aspirin (Part B)|Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
10803668|NCT02688933|BG000|Baseline|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803669|NCT02688933|BG001|Baseline|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803670|NCT02688933|BG002|Baseline|Total|Total of all reporting groups
10803671|NCT02688933|FG000|Participant Flow|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting self-measured plasma glucose (SMPG) levels within the target range of 80 to 100 mg/dL.
10803672|NCT02688933|FG001|Participant Flow|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803673|NCT02688933|OG000|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803674|NCT02688933|OG001|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803675|NCT02688933|EG000|Reported Event|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803676|NCT02688933|EG001|Reported Event|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 16 on top of mealtime insulin analogs. Basal insulin doses were individually titrated to reach fasting SMPG levels within the target range of 80 to 100 mg/dL.
10803677|NCT02550197|BG000|Baseline|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
10803678|NCT02550197|BG001|Baseline|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
10803679|NCT02550197|BG002|Baseline|Total|Total of all reporting groups
10803680|NCT02550197|FG000|Participant Flow|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
10779266|NCT03434041|BG000|Baseline|Intranasal Esketamine + Oral Antidepressant (AD)|Participants received intranasal esketamine 56 milligrams (mg) or 84 mg twice per week for 4 weeks as a flexible dose regimen. All participants started at a dose of 56 mg on Day 1. The dose could be increased to 84 mg or maintained at 56 mg per investigator's discretion. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine extended release [XR]) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779267|NCT03434041|BG001|Baseline|Intranasal Placebo + Oral AD|Participants received intranasal placebo twice per week for 4 weeks as a flexible dose regimen. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine XR) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779268|NCT03434041|BG002|Baseline|Total|Total of all reporting groups
10779269|NCT03434041|FG000|Participant Flow|Intranasal Esketamine + Oral Antidepressant (AD)|Participants received intranasal esketamine 56 milligrams (mg) or 84 mg twice per week for 4 weeks as a flexible dose regimen. All participants started at a dose of 56 mg on Day 1. The dose could be increased to 84 mg or maintained at 56 mg per investigator's discretion. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine extended release [XR]) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779270|NCT03434041|FG001|Participant Flow|Intranasal Placebo + Oral AD|Participants received intranasal placebo twice per week for 4 weeks as a flexible dose regimen. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine XR) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779271|NCT03434041|OG000|Outcome|Intranasal Esketamine + Oral Antidepressant (AD)|Participants received intranasal esketamine 56 milligrams (mg) or 84 mg twice per week for 4 weeks as a flexible dose regimen. All participants started at a dose of 56 mg on Day 1. The dose could be increased to 84 mg or maintained at 56 mg per investigator's discretion. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine extended release [XR]) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779272|NCT03434041|OG001|Outcome|Intranasal Placebo + Oral AD|Participants received intranasal placebo twice per week for 4 weeks as a flexible dose regimen. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine XR) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase. The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks in the follow-up phase unless it was determined not to be clinically appropriate.
10779273|NCT03434041|EG000|Reported Event|Double-blind: Intranasal Esketamine+ Oral Antidepressant (AD)|Participants received intranasal esketamine 56 milligrams (mg) or 84 mg twice per week for 4 weeks as a flexible dose regimen. All participants started at a dose of 56 mg on Day 1. The dose could be increased to 84 mg or maintained at 56 mg per investigator's discretion. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine extended release [XR]) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase.
10779274|NCT03434041|EG001|Reported Event|Double-blind: Oral AD + Intranasal Placebo|Participants received intranasal placebo twice per week for 4 weeks as a flexible dose regimen. Participants simultaneously received 1 of the 4 open-label oral antidepressant treatment (duloxetine, escitalopram, sertraline, or venlafaxine XR) on Day 1 that was continued for the duration of the 4-week Double-Blind Treatment Phase.
10779275|NCT03434041|EG002|Reported Event|Follow-up: Intranasal Esketamine+ Oral AD|The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks of the follow-up phase unless it was determined to not be clinically appropriate. No intranasal study medication was administered during this phase.
10779276|NCT03434041|EG003|Reported Event|Follow-up: Oral AD + Intranasal Placebo|The follow-up phase included participants who received at least 1 dose of intranasal study medication in the double-blind treatment phase. Participants received oral AD for 8 weeks of the follow-up phase unless it was determined to not be clinically appropriate. No intranasal study medication was administered during this phase.
10779277|NCT03420222|BG000|Baseline|AVP-786|Participants received AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
10779278|NCT03420222|BG001|Baseline|Placebo|Participants received placebo BID for 12 weeks.
10779279|NCT03420222|BG002|Baseline|Total|Total of all reporting groups
11379038|NCT04020718|OG000|Outcome|Early Assessment Non-responder NRT|Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching
11240958|NCT02483416|FG000|Participant Flow|Group With Nurse-led Telephone Follow-up|Group with remote additional personalised nurse-led follow-up: patients received telephone calls from a nurse in addition to the healthcare given routinely by their medical team
11240959|NCT02483416|FG001|Participant Flow|Group Without Nurse-led Telephone Follow-up|Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
11240960|NCT02483416|OG000|Outcome|Group With Nurse-led Telephone Follow-up|Group with remote additional personalised nurse-led follow-up: patients received telephone calls from a nurse in addition to the healthcare given routinely by their medical team
11240961|NCT02483416|OG001|Outcome|Group Without Nurse-led Telephone Follow-up|Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
11240962|NCT02483416|EG000|Reported Event|Group With Nurse-led Telephone Follow-up|Group with remote additional personalised nurse-led follow-up: patients received telephone calls from a nurse in addition to the healthcare given routinely by their medical team
11240963|NCT02483416|EG001|Reported Event|Group Without Nurse-led Telephone Follow-up|Group without remote additional personalised nurse-led follow-up: patients received the healthcare given routinely by their medical team
11240964|NCT02483416|EG002|Reported Event|Total|Total of reporting groups
11240965|NCT02483520|BG000|Baseline|Intervention FamTechCare|"This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240966|NCT02483520|BG001|Baseline|Control and Delayed FamTechCare|"This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240967|NCT02483520|BG002|Baseline|Total|Total of all reporting groups
11240968|NCT02483520|FG000|Participant Flow|Intervention FamTechCare|"This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240969|NCT02483520|FG001|Participant Flow|Control and Delayed FamTechCare|"This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240970|NCT02483520|OG000|Outcome|Intervention FamTechCare|"This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240971|NCT02483520|OG001|Outcome|Control and Delayed FamTechCare|"This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240972|NCT02483520|EG000|Reported Event|Intervention FamTechCare|"This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11379039|NCT04020718|OG001|Outcome|Early Assessment Non-responder NRT Plus Coaching|Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching
10779280|NCT03420222|FG000|Participant Flow|AVP-786|Participants received AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
11240973|NCT02483520|EG001|Reported Event|Control and Delayed FamTechCare|"This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).~FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care."
11240974|NCT02483572|BG000|Baseline|Functional Communication Training|"Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.~Functional Communication Training: Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention)"
10779281|NCT03420222|FG001|Participant Flow|Placebo|Participants received placebo BID for 12 weeks.
10779282|NCT03420222|OG000|Outcome|AVP-786|Participants received AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
10779283|NCT03420222|OG001|Outcome|Placebo|Participants received placebo BID for 12 weeks.
10779284|NCT03420222|EG000|Reported Event|AVP-786|Participants received AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
10779285|NCT03420222|EG001|Reported Event|Placebo|Participants received placebo BID for 12 weeks.
10779286|NCT03409796|BG000|Baseline|Group A: Gluten 3 Gram|Gluten 3 gram, powder, orally, once daily up to 14 days.
10779287|NCT03409796|BG001|Baseline|Group B: Gluten 10 Gram|Gluten 10 gram, powder, orally, once daily up to 14 days.
10779288|NCT03409796|BG002|Baseline|Total|Total of all reporting groups
10779289|NCT03409796|FG000|Participant Flow|Group A: Gluten 3 Gram|Gluten 3 gram, powder, orally, once daily up to 14 days.
10779290|NCT03409796|FG001|Participant Flow|Group B: Gluten 10 Gram|Gluten 10 gram, powder, orally, once daily up to 14 days.
10779291|NCT03409796|OG000|Outcome|Group A: Gluten 3 Gram|Gluten 3 gram, powder, orally, once daily up to 14 days.
10779292|NCT03409796|OG001|Outcome|Group B: Gluten 10 Gram|Gluten 10 gram, powder, orally, once daily up to 14 days.
10779293|NCT03409796|EG000|Reported Event|Group A: Gluten 3 Gram|Gluten 3 gram, powder, orally, once daily up to 14 days.
10779294|NCT03409796|EG001|Reported Event|Group B: Gluten 10 Gram|Gluten 10 gram, powder, orally, once daily up to 14 days.
10779295|NCT03215706|BG000|Baseline|Treatment A|Nivolumab + Ipilimumab + Chemotherapy
10779296|NCT03215706|BG001|Baseline|Treatment B|Chemotherapy only
10779297|NCT03215706|BG002|Baseline|Total|Total of all reporting groups
10779298|NCT03215706|FG000|Participant Flow|Treatment A|Nivolumab + Ipilimumab + Chemotherapy
10779299|NCT03215706|FG001|Participant Flow|Treatment B|Chemotherapy only
11193433|NCT02145039|FG000|Participant Flow|Haploidentical Stem Cell Transplant|"This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).~Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.~Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.~Total Body Irradiation: TBI 200cGy (centigray) on day -1 before transplant.~Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion"
11339718|NCT03635957|OG000|Outcome|Pegloticase With Methotrexate (MTX)|"Run-In Period: oral MTX at a dose of 15 mg weekly for 4 weeks prior to the first dose of pegloticase.~Pegloticase + IMM Period: pegloticase 8 mg administered IV every 2 weeks from Day 1 through the Week 50 Visit for a total of 26 infusions. MTX 15 mg weekly on the same day each week, within 1 to 3 days prior to each pegloticase infusion and one additional weekly dose after the last infusion."
10779300|NCT03215706|OG000|Outcome|Treatment A|Nivolumab + Ipilimumab + Chemotherapy
10779301|NCT03215706|OG001|Outcome|Treatment B|Chemotherapy only
10779302|NCT03215706|EG000|Reported Event|Treatment A|Nivolumab + Ipilimumab + Chemotherapy
10779303|NCT03215706|EG001|Reported Event|Treatment B|Chemotherapy only
10779304|NCT03189563|BG000|Baseline|Placebo|"placebo, tid~Placebo: Placebo, tid"
10779305|NCT03189563|BG001|Baseline|DA-9805 Low|"DA-9805 45mg~DA-9805 45mg: DA-9805 15mg tid"
10779306|NCT03189563|BG002|Baseline|DA-9805 High|"DA-9805 90mg~DA-9805 90mg: DA-9805 30mg tid"
10779307|NCT03189563|BG003|Baseline|Total|Total of all reporting groups
10779308|NCT03189563|FG000|Participant Flow|Placebo|"placebo, tid~Placebo: Placebo, tid"
10779309|NCT03189563|FG001|Participant Flow|DA-9805 Low|"DA-9805 45mg~DA-9805 45mg: DA-9805 15mg tid"
10779310|NCT03189563|FG002|Participant Flow|DA-9805 High|"DA-9805 90mg~DA-9805 90mg: DA-9805 30mg tid"
10779311|NCT03189563|OG000|Outcome|Placebo|"placebo, tid~Placebo: Placebo, tid"
10779312|NCT03189563|OG001|Outcome|DA-9805 Low|"DA-9805 45mg~DA-9805 45mg: DA-9805 15mg tid"
10779313|NCT03189563|OG002|Outcome|DA-9805 High|"DA-9805 90mg~DA-9805 90mg: DA-9805 30mg tid"
10779314|NCT03189563|EG000|Reported Event|Placebo|"placebo, tid~Placebo: Placebo, tid"
10779315|NCT03189563|EG001|Reported Event|DA-9805 Low|"DA-9805 45mg~DA-9805 45mg: DA-9805 15mg tid"
10779316|NCT03189563|EG002|Reported Event|DA-9805 High|"DA-9805 90mg~DA-9805 90mg: DA-9805 30mg tid"
10779317|NCT03144674|BG000|Baseline|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779318|NCT03144674|BG001|Baseline|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779319|NCT03144674|BG002|Baseline|Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779320|NCT03144674|BG003|Baseline|Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779321|NCT03144674|BG004|Baseline|Total|Total of all reporting groups
10779322|NCT03144674|FG000|Participant Flow|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779323|NCT03144674|FG001|Participant Flow|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779324|NCT03144674|FG002|Participant Flow|Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group
10779325|NCT03144674|FG003|Participant Flow|Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779326|NCT03144674|OG000|Outcome|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779327|NCT03144674|OG001|Outcome|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
11193434|NCT02145039|OG000|Outcome|Haploidentical Stem Cell Transplant|"This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).~Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.~Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.~Total Body Irradiation: TBI 200cGy on day -1 before transplant.~Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion"
11193435|NCT02145039|EG000|Reported Event|Haploidentical Stem Cell Transplant|"This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).~Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.~Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.~Total Body Irradiation: TBI 200cGy on day -1 before transplant.~Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion"
10779328|NCT03144674|OG002|Outcome|Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779329|NCT03144674|OG003|Outcome|Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779330|NCT03144674|OG000|Outcome|Cohort 1: Ibrutinib Experienced (Treatment A)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779331|NCT03144674|OG001|Outcome|Cohort 1: Ibrutinib Experienced (Treatment B)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779332|NCT03144674|OG002|Outcome|Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment A)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779333|NCT03144674|OG003|Outcome|Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment B)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779334|NCT03144674|EG000|Reported Event|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
11339719|NCT03635957|EG000|Reported Event|Run-In Period: MTX|Run-In Period: oral MTX at a dose of 15 mg weekly for 4 weeks prior to the first dose of pegloticase.
11379040|NCT04020718|OG002|Outcome|Early Assessment Responder|Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages
10779335|NCT03144674|EG001|Reported Event|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10779336|NCT03144674|EG002|Reported Event|Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779337|NCT03144674|EG003|Reported Event|Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10779338|NCT03144674|EG004|Reported Event|Total|Total
10803681|NCT02550197|FG001|Participant Flow|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
10803682|NCT02550197|OG000|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
10803683|NCT02550197|OG001|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
10964408|NCT00877370|BG000|Baseline|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
10964409|NCT00877370|FG000|Participant Flow|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
10964410|NCT00877370|OG000|Outcome|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
10966595|NCT00887653|FG000|Participant Flow|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
10779352|NCT03093350|BG000|Baseline|TAA-Specific CTLs|"Patients receiving TAA-specific CTLs as therapy for breast cancer.~TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.~Dose schedule:~Day 0: 2 x 10^7 cells/m2~Day 28: 2 x 10^7 cells/m2~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
10779353|NCT03093350|FG000|Participant Flow|TAA-Specific CTLs|"Patients receiving TAA-specific CTLs as therapy for breast cancer.~TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.~Dose schedule:~Day 0: 2 x 10^7 cells/m2~Day 28: 2 x 10^7 cells/m2~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
10779354|NCT03093350|OG000|Outcome|TAA-Specific CTLs|"Patients receiving TAA-specific CTLs as therapy for breast cancer.~TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.~Dose schedule:~Day 0: 2 x 10^7 cells/m2~Day 28: 2 x 10^7 cells/m2~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
10779355|NCT03093350|EG000|Reported Event|TAA-Specific CTLs|"Patients receiving TAA-specific CTLs as therapy for breast cancer.~TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.~Dose schedule:~Day 0: 2 x 10^7 cells/m2~Day 28: 2 x 10^7 cells/m2~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
10779356|NCT03070236|BG000|Baseline|Guideline Concordant Care (GCC)|Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.
10779357|NCT03070236|BG001|Baseline|Active Surveillance (AS)|Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
10779358|NCT03070236|BG002|Baseline|Total|Total of all reporting groups
10779359|NCT03070236|FG000|Participant Flow|Guideline Concordant Care (GCC) & Active Surveillance (AS)|"Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.~Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation."
10779360|NCT03070236|OG000|Outcome|Guideline Concordant Care (GCC)|Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.
10779361|NCT03070236|OG001|Outcome|Active Surveillance (AS)|Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
10779362|NCT03070236|EG000|Reported Event|Guideline Concordant Care (GCC) & Active Surveillance (AS)|"Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.~Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation."
10779363|NCT02999854|BG000|Baseline|ATIR101|"T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT~ATIR101: ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)~T-cell depleted HSCT from a related, haploidentical donor: T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779364|NCT02999854|BG001|Baseline|PTCy|"T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT~Cyclophosphamide: High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)~T-cell replete HSCT from a related, haploidentical donor: T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779365|NCT02999854|BG002|Baseline|Total|Total of all reporting groups
10779366|NCT02999854|FG000|Participant Flow|ATIR101|"T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT~ATIR101: ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)~T-cell depleted HSCT from a related, haploidentical donor: T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779367|NCT02999854|FG001|Participant Flow|PTCy|"T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT~Cyclophosphamide: High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)~T-cell replete HSCT from a related, haploidentical donor: T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779368|NCT02999854|OG000|Outcome|ATIR101|"T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT~ATIR101: ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)~T-cell depleted HSCT from a related, haploidentical donor: T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779369|NCT02999854|OG001|Outcome|PTCy|"T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT~Cyclophosphamide: High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)~T-cell replete HSCT from a related, haploidentical donor: T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779370|NCT02999854|EG000|Reported Event|ATIR101|"T-cell depleted HSCT from a related, haploidentical donor, followed by IV infusion with ATIR101 at a single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT~ATIR101: ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)~T-cell depleted HSCT from a related, haploidentical donor: T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
10779371|NCT02999854|EG001|Reported Event|PTCy|"T-cell replete HSCT from a related, haploidentical donor, followed by IV infusion of post-transplant cyclophosphamide (PTCy) 50 mg/kg/day at 3 and 4/5 days after the HSCT~Cyclophosphamide: High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)~T-cell replete HSCT from a related, haploidentical donor: T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen"
11379041|NCT04020718|OG003|Outcome|Late Assessment Non-responder NRT|Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching
10803684|NCT02550197|EG000|Reported Event|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
10779372|NCT02960763|BG000|Baseline|Aripiprazole Augmentation|"Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.~Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects."
10779373|NCT02960763|BG001|Baseline|Bupropion Augmentation|"Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.~Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779374|NCT02960763|BG002|Baseline|Switch to Bupropion|"Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.~Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779375|NCT02960763|BG003|Baseline|Lithium Augmentation|"Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.~Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L."
10779376|NCT02960763|BG004|Baseline|Switch to Nortriptyline|"Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.~Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml"
10779377|NCT02960763|BG005|Baseline|Total|Total of all reporting groups
10779378|NCT02960763|FG000|Participant Flow|Aripiprazole Augmentation|"Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.~Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects."
10779379|NCT02960763|FG001|Participant Flow|Bupropion Augmentation|"Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.~Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779380|NCT02960763|FG002|Participant Flow|Switch to Bupropion|"Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.~Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779381|NCT02960763|FG003|Participant Flow|Lithium Augmentation|"Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.~Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L."
10779382|NCT02960763|FG004|Participant Flow|Switch to Nortriptyline|"Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.~Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml"
10779383|NCT02960763|OG000|Outcome|Aripiprazole Augmentation|"Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.~Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects."
10779384|NCT02960763|OG001|Outcome|Bupropion Augmentation|"Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.~Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779385|NCT02960763|OG002|Outcome|Switch to Bupropion|"Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.~Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779386|NCT02960763|OG003|Outcome|Lithium Augmentation|"Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.~Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L."
10779387|NCT02960763|OG004|Outcome|Switch to Nortriptyline|"Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.~Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml"
10779388|NCT02960763|EG000|Reported Event|Aripiprazole Augmentation|"Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.~Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects."
10779389|NCT02960763|EG001|Reported Event|Bupropion Augmentation|"Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.~Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779390|NCT02960763|EG002|Reported Event|Switch to Bupropion|"Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.~Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects."
10779391|NCT02960763|EG003|Reported Event|Lithium Augmentation|"Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.~Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L."
10779392|NCT02960763|EG004|Reported Event|Switch to Nortriptyline|"Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.~Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml"
10779393|NCT02839343|BG000|Baseline|Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)|Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779394|NCT02839343|BG001|Baseline|Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)|Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779395|NCT02839343|BG002|Baseline|Total|Total of all reporting groups
10779396|NCT02839343|FG000|Participant Flow|Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)|Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779397|NCT02839343|FG001|Participant Flow|Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)|Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779398|NCT02839343|OG000|Outcome|Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)|Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779399|NCT02839343|OG001|Outcome|Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)|Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
11193436|NCT02145078|BG000|Baseline|Treatment (Chemotherapy Regimen)|"Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.~docetaxel: Given IV~pemetrexed disodium: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
11193437|NCT02145078|FG000|Participant Flow|Treatment (Chemotherapy Regimen)|"Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.~docetaxel: Given IV~pemetrexed disodium: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
11193438|NCT02145078|OG000|Outcome|Treatment (Chemotherapy Regimen)|"Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.~docetaxel: Given IV~pemetrexed disodium: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
11379042|NCT04020718|OG004|Outcome|Late Assessment Non-responder NRT Plus Coaching|Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching
10779400|NCT02839343|EG000|Reported Event|Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)|Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779401|NCT02839343|EG001|Reported Event|Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)|Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
10779402|NCT02819479|BG000|Baseline|Low-dose Intra-arterial Avastin (Bevacizumab)|"A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.~25% Mannitol: Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.~Low-dose Intra-arterial Bevacizumab: Route of administration:~In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery."
10803685|NCT02550197|EG001|Reported Event|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
11193439|NCT02145078|EG000|Reported Event|Treatment (Chemotherapy Regimen)|"Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.~docetaxel: Given IV~pemetrexed disodium: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
11193440|NCT02145156|BG000|Baseline|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11193441|NCT02145156|BG001|Baseline|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11379043|NCT04020718|OG005|Outcome|Late Assessment Responder|Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
11379044|NCT04020718|OG002|Outcome|Early Assessment Responder|Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continued text messages.
11379045|NCT04020718|OG005|Outcome|Late Assessment Responder|Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continued text messages
11379046|NCT04020718|OG000|Outcome|Mailed 4-week Supply of Combination NRT|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379047|NCT04020718|OG001|Outcome|Mailed 4-week Supply of Combination NRT Plus Proactive Telephone Coaching|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379048|NCT04020718|OG002|Outcome|Early Assessment Responder|Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.
11379049|NCT04020718|EG000|Reported Event|Early Assessment Non-responder NRT|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379050|NCT04020718|EG001|Reported Event|Early Assessment Non-responder NRT Plus Coaching|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379051|NCT04020718|EG002|Reported Event|Early Assessment Responder|Reported 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.
11379052|NCT04020718|EG003|Reported Event|Late Assessment Non-responder NRT|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379053|NCT04020718|EG004|Reported Event|Late Assessment Non-responder NRT Plus Coaching|"Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.~Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.~Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.~Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities."
11379054|NCT03970109|BG000|Baseline|ANS-6637 - 200mg|"200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379055|NCT03970109|BG001|Baseline|ANS-6637 - 600mg|"600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379056|NCT03970109|BG002|Baseline|Matched Placebo|"2 placebo tablets once a day~Placebo oral tablet: Placebo oral tablet"
11379057|NCT03970109|BG003|Baseline|Total|Total of all reporting groups
11379058|NCT03970109|FG000|Participant Flow|ANS-6637 - 200mg|"200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379059|NCT03970109|FG001|Participant Flow|ANS-6637 - 600mg|"600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379060|NCT03970109|FG002|Participant Flow|Matched Placebo|"2 placebo tablets once a day~Placebo oral tablet: Placebo oral tablet"
11379061|NCT03970109|OG000|Outcome|ANS-6637 - 200mg|"200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379062|NCT03970109|OG001|Outcome|ANS-6637 - 600mg|"600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379063|NCT03970109|OG002|Outcome|Matched Placebo|"2 placebo tablets once a day~Placebo oral tablet: Placebo oral tablet"
11379064|NCT03970109|EG000|Reported Event|ANS-6637 - 200mg|"200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379065|NCT03970109|EG001|Reported Event|ANS-6637 - 600mg|"600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day~ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day"
11379066|NCT03970109|EG002|Reported Event|Matched Placebo|"2 placebo tablets once a day~Placebo oral tablet: Placebo oral tablet"
11379067|NCT03954743|BG000|Baseline|HRV PCV-free Liq Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11379068|NCT03954743|BG001|Baseline|HRV Lyo Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
11379069|NCT03954743|BG002|Baseline|Total|Total of all reporting groups
11379070|NCT03954743|FG000|Participant Flow|HRV PCV-free Liq Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11379071|NCT03954743|FG001|Participant Flow|HRV Lyo Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
11379072|NCT03954743|OG000|Outcome|HRV PCV-free Liq Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11379073|NCT03954743|OG001|Outcome|HRV Lyo Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
11379074|NCT03954743|EG000|Reported Event|HRV PCV-free Liq Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11379075|NCT03954743|EG001|Reported Event|HRV Lyo Group|Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
11379076|NCT03880565|BG000|Baseline|ECMO Facilitated Resuscitation|"Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.~Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO"
11379077|NCT03880565|BG001|Baseline|Standard ACLS Resuscitation|"Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.~Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation"
11379078|NCT03880565|BG002|Baseline|Total|Total of all reporting groups
11379079|NCT03880565|FG000|Participant Flow|ECMO Facilitated Resuscitation|"Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.~Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO"
11379080|NCT03880565|FG001|Participant Flow|Standard ACLS Resuscitation|"Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.~Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation"
10803686|NCT02492165|BG000|Baseline|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
11193442|NCT02145156|BG002|Baseline|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11193443|NCT02145156|BG003|Baseline|Total|Total of all reporting groups
11379081|NCT03880565|OG000|Outcome|ECMO Facilitated Resuscitation|"Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.~Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO"
11379082|NCT03880565|OG001|Outcome|Standard ACLS Resuscitation|"Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.~Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation"
11379083|NCT03880565|EG000|Reported Event|ECMO Facilitated Resuscitation|"Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.~Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO"
11379084|NCT03880565|EG001|Reported Event|Standard ACLS Resuscitation|"Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.~Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation"
11379085|NCT03833661|BG000|Baseline|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11379086|NCT03833661|FG000|Participant Flow|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11379087|NCT03833661|OG000|Outcome|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11379088|NCT03833661|EG000|Reported Event|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11379089|NCT03809663|BG000|Baseline|Part A: Placebo|"Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379090|NCT03809663|BG001|Baseline|Part A: Tezepelumab 210 mg Q4W|"Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379091|NCT03809663|BG002|Baseline|Part A: Tezepelumab 280 mg Q2W|"Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379092|NCT03809663|BG003|Baseline|Part A: Tezepelumab 420 mg Q2W|"Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379093|NCT03809663|BG004|Baseline|Total|Total of all reporting groups
11379094|NCT03809663|FG000|Participant Flow|Part A: Placebo|"Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379095|NCT03809663|FG001|Participant Flow|Part A: Tezepelumab 210 mg Q4W|"Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379096|NCT03809663|FG002|Participant Flow|Part A: Tezepelumab 280 mg Q2W|"Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379097|NCT03809663|FG003|Participant Flow|Part A: Tezepelumab 420 mg Q2W|"Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379098|NCT03809663|FG004|Participant Flow|Part B: Placebo and Topical Corticosteroids Regimen|"Matching placebo was planned to be administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.~The study was terminated prior to the start of Part 2 and no participants were enrolled."
11379099|NCT03809663|FG005|Participant Flow|Part B: Tezepelumab 420 mg Q2W and Topical Corticosteroids Regimen|"Tezepelumab 420 mg was planned to be administered via SC injection Q2W with TCS for a maximum of 52 weeks.~The study was terminated prior to the start of Part 2 and no participants were enrolled."
11379100|NCT03809663|OG000|Outcome|Part A: Placebo|"Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379101|NCT03809663|OG001|Outcome|Part A: Tezepelumab 210 mg Q4W|"Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379102|NCT03809663|OG002|Outcome|Part A: Tezepelumab 280 mg Q2W|"Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
10779403|NCT02819479|FG000|Participant Flow|Low-dose Intra-arterial Bevacizumab|"A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.~25% Mannitol: Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.~Low-dose Intra-arterial Bevacizumab: Route of administration:~In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery."
10779404|NCT02819479|OG000|Outcome|Low-dose Intra-arterial Avastin (Bevacizumab)|"A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.~25% Mannitol: Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.~Low-dose Intra-arterial bevacizumab: Route of administration:~In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery."
10779405|NCT02819479|OG000|Outcome|Low-dose Intra-arterial Bevacizumab|"A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.~25% Mannitol: Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.~Low-dose Intra-arterial Bevacizumab: Route of administration:~In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery."
10779406|NCT02819479|EG000|Reported Event|Low-dose Intra-arterial Bevacizumab|"A single intra-arterial dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.~25% Mannitol: Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.~Low-dose Intra-arterial Bevacizumab: Route of administration:~In this study, the second step of the treatment will be administering intra-arterial bevacizumab into the appropriate cervical artery."
10801101|NCT02573493|OG003|Outcome|Arm 1 CRT: Cisplatin + Radiation Therapy|"CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801102|NCT02573493|OG004|Outcome|Arm 1 & 2 ERT: Cetuximab + Radiation Therapy|"CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.~It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801103|NCT02573493|OG005|Outcome|Arm 3 CR: Cisplatin + Radiation Therapy|"CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801104|NCT02573493|OG001|Outcome|Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT"
10801105|NCT02573493|OG002|Outcome|Arm 1 CRT: Cisplatin + Radiation Therapy|"CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
11339720|NCT03635957|EG001|Reported Event|Pegloticase + IMM Period: Pegloticase + MTX|Pegloticase + IMM Period: pegloticase 8 mg administered IV every 2 weeks from Day 1 through the Week 50 Visit for a total of 26 infusions. MTX 15 mg weekly on the same day each week, within 1 to 3 days prior to each pegloticase infusion and one additional weekly dose after the last infusion.
11339721|NCT03636061|BG000|Baseline|OC-01 Low Dose, 0.12 mg/mL|OC-01 0.12 mg/ml nasal spray BID for 28 days
10801106|NCT02573493|OG003|Outcome|Arm 3 CR: Cisplatin + Radiation Therapy|"CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801107|NCT02573493|EG000|Reported Event|Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction|"Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment~If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)~If <PR, move directly to CRT if not surgical candidates."
11339722|NCT03636061|BG001|Baseline|OC-01 Mid Dose, 0.6 mg/mL|OC-01 0.6 mg/ml nasal spray BID for 28 days
11339723|NCT03636061|BG002|Baseline|OC-01 High Dose, 1.2 mg/mL|OC-01 1.2 mg/ml nasal spray BID for 28 days
11339724|NCT03636061|BG003|Baseline|Placebo|Vehicle nasal spray
11339725|NCT03636061|BG004|Baseline|Total|Total of all reporting groups
10779407|NCT02601313|BG000|Baseline|2 x 10^6 Axicabtagene Ciloleucel|Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg on Day 0.
10779408|NCT02601313|BG001|Baseline|Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779409|NCT02601313|BG002|Baseline|Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779410|NCT02601313|BG003|Baseline|Total|Total of all reporting groups
10779411|NCT02601313|FG000|Participant Flow|2 x 10^6 Axicabtagene Ciloleucel|Participants with relapsed/refractory mantle cell lymphoma (MCL) received conditioning chemotherapy (CTE) consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg on Day 0.
10779412|NCT02601313|FG001|Participant Flow|Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779413|NCT02601313|FG002|Participant Flow|Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779414|NCT02601313|OG000|Outcome|Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779415|NCT02601313|OG000|Outcome|Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779416|NCT02601313|OG001|Outcome|Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779417|NCT02601313|EG000|Reported Event|2 x 10^6 Axicabtagene Ciloleucel|Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg on Day 0.
11339726|NCT03636061|FG000|Participant Flow|OC-01 Low Dose, 0.12 mg/ml|OC-01 0.12 mg/ml nasal spray BID for 28 days
10779418|NCT02601313|EG001|Reported Event|Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10779419|NCT02601313|EG002|Reported Event|Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel|Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
10801108|NCT02573493|EG001|Reported Event|Arm 2: Nab-Paclitaxel (A) Induction|"Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment~If CR/PR, three more weeks of nab-paclitaxel followed by CRT~If <PR, move directly to CRT if not surgical candidates."
11339727|NCT03636061|FG001|Participant Flow|OC-01 Mid Dose, 0.6 mg/ml|OC-01 0.6 mg/ml nasal spray BID for 28 days
11193444|NCT02145156|FG000|Participant Flow|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11193445|NCT02145156|FG001|Participant Flow|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11193446|NCT02145156|FG002|Participant Flow|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
10779424|NCT02542293|BG000|Baseline|All Participants: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779425|NCT02542293|BG001|Baseline|All Participants: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779426|NCT02542293|BG002|Baseline|Total|Total of all reporting groups
10779427|NCT02542293|FG000|Participant Flow|All Participants: Durvalumab + Tremelimumab|Participants received durvalumab 20 milligram per kilogram (mg/kg) and tremelimumab 1 mg/kg intravenous (IV) infusion every 4 weeks (Q4W) in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective disease progression (PD), initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779428|NCT02542293|FG001|Participant Flow|All Participants: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/square meter (m^2) and carboplatin area under the plasma concentration curve (AUC) 5 or 6 mg*minute per milliliter (mg*min/mL).~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779429|NCT02542293|OG000|Outcome|Global: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779430|NCT02542293|OG001|Outcome|Global: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
11193447|NCT02145156|OG000|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
10779431|NCT02542293|OG000|Outcome|China: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
11193448|NCT02145156|OG001|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
10779432|NCT02542293|OG001|Outcome|China: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779433|NCT02542293|OG002|Outcome|China: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779434|NCT02542293|OG003|Outcome|China: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779435|NCT02542293|OG001|Outcome|China: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779436|NCT02542293|EG000|Reported Event|Global: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10779437|NCT02542293|EG001|Reported Event|Global: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779438|NCT02542293|EG002|Reported Event|China: Durvalumab + Tremelimumab|Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.
10801109|NCT02573493|EG002|Reported Event|Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction|"6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment~If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab~If SD/PD: undergo surgery if candidate followed by CRT"
10803687|NCT02492165|BG001|Baseline|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10803688|NCT02492165|BG002|Baseline|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
11193449|NCT02145156|OG002|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11193450|NCT02145156|EG000|Reported Event|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11339728|NCT03636061|FG002|Participant Flow|OC-01 High Dose, 1.2 mg/ml|OC-01 1.2 mg/ml nasal spray BID for 28 days
11339729|NCT03636061|FG003|Participant Flow|Placebo|Placebo (vehicle) nasal spray
11339730|NCT03636061|OG000|Outcome|OC-01 Low Dose, 0.12 mg/mL|OC-01 0.12 mg/ml nasal spray
10779439|NCT02542293|EG003|Reported Event|China: SoC Chemotherapy|"Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.~Paclitaxel 200 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL.~Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m^2 on Day 8 of each cycle (For squamous participants only).~Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).~Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 mg*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted)."
10779440|NCT02484430|BG000|Baseline|Treatment (Sapanisertib)|Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10779441|NCT02484430|FG000|Participant Flow|Treatment (Sapanisertib)|Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10779442|NCT02484430|OG000|Outcome|Treatment (Sapanisertib)|Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10779443|NCT02484430|EG000|Reported Event|Treatment (Sapanisertib)|Patients receive 3 mg sapanisertib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive 3 mg sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10779444|NCT02438722|BG000|Baseline|Arm I (Afatinib Dimaleate, Cetuximab)|"Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10779445|NCT02438722|BG001|Baseline|Arm II (Afatinib Dimaleate)|"Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10779446|NCT02438722|BG002|Baseline|Total|Total of all reporting groups
10779447|NCT02438722|FG000|Participant Flow|Arm I (Afatinib Dimaleate, Cetuximab)|"Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10779448|NCT02438722|FG001|Participant Flow|Arm II (Afatinib Dimaleate)|"Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10779449|NCT02438722|OG000|Outcome|Arm I (Afatinib Dimaleate, Cetuximab)|"Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10779450|NCT02438722|OG001|Outcome|Arm II (Afatinib Dimaleate)|"Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10779451|NCT02438722|EG000|Reported Event|Arm I (Afatinib Dimaleate, Cetuximab)|"Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10779452|NCT02438722|EG001|Reported Event|Arm II (Afatinib Dimaleate)|"Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Afatinib Dimaleate: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10779453|NCT02425306|BG000|Baseline|Arm A:6MHP + Montanide ISA-51|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant"
10779454|NCT02425306|BG001|Baseline|Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779455|NCT02425306|BG002|Baseline|Arm C:6MHP + polyICLC + Montanide ISA-51|"Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant"
10803689|NCT02492165|BG003|Baseline|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10803690|NCT02492165|BG004|Baseline|Total|Total of all reporting groups
11339731|NCT03636061|OG001|Outcome|OC-01 Mid Dose, 0.6 mg/ML|OC-01 0.6 mg/ml nasal spray
11339732|NCT03636061|OG002|Outcome|OC-01 High Dose, 1.2 mg/mL|OC-01 1.2 mg/ml nasal spray
10779456|NCT02425306|BG003|Baseline|Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide|"Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779457|NCT02425306|BG004|Baseline|Total|Total of all reporting groups
10779458|NCT02425306|FG000|Participant Flow|Arm A:6MHP + Montanide ISA-51|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant"
10779459|NCT02425306|FG001|Participant Flow|Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779460|NCT02425306|FG002|Participant Flow|Arm C:6MHP + polyICLC + Montanide ISA-51|"Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant"
10779461|NCT02425306|FG003|Participant Flow|Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide|"Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779462|NCT02425306|OG000|Outcome|Arm A:6MHP + Montanide ISA-51|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant"
10779463|NCT02425306|OG001|Outcome|Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779464|NCT02425306|OG002|Outcome|Arm C:6MHP + polyICLC + Montanide ISA-51|"Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant"
10779465|NCT02425306|OG003|Outcome|Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide|"Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779466|NCT02425306|EG000|Reported Event|Arm A:6MHP + Montanide ISA-51|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant"
10779467|NCT02425306|EG001|Reported Event|Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide|"Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10779468|NCT02425306|EG002|Reported Event|Arm C:6MHP + polyICLC + Montanide ISA-51|"Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant"
10803691|NCT02492165|FG000|Participant Flow|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10803692|NCT02492165|FG001|Participant Flow|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
11339733|NCT03636061|OG003|Outcome|Placebo|Vehicle nasal spray
11339734|NCT03636061|OG000|Outcome|OC-01 Low Dose, 0.12 mg/ml|OC-01 0.12 mg/ml nasal spray
11339735|NCT03636061|OG001|Outcome|OC-01 Mid Dose, 0.6 mg/ml|OC-01 0.6 mg/ml nasal spray
10779469|NCT02425306|EG003|Reported Event|Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide|"Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:~Day -6 (Cycle 1)~Day 8 (Cycle 2)~Day 22 (Cycle 3)~Day 36 (Cycle 4)~Day 50 (Cycle 5)~6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides~Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant~polyICLC: polyICLC, local adjuvant~Cyclophosphamide: Cyclophosphamide, systemic adjuvant"
10964411|NCT00877370|EG000|Reported Event|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
10964412|NCT00877383|BG000|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10964413|NCT00877383|BG001|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10964414|NCT00877383|BG002|Baseline|Total|Total of all reporting groups
10964415|NCT00877383|FG000|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11193451|NCT02145156|EG001|Reported Event|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
10964416|NCT00877383|FG001|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11339736|NCT03636061|OG002|Outcome|OC-01 High Dose, 1.2 mg/ml|OC-01 1.2 mg/ml nasal spray
10964417|NCT00877383|OG000|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10779490|NCT02120352|BG000|Baseline|CAB 30 mg+ABC/3TC QD|In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
10779491|NCT02120352|FG000|Participant Flow|CAB 30 mg+ABC/3TC QD (Induction Period)|In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
10779492|NCT02120352|FG001|Participant Flow|CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
10779493|NCT02120352|FG002|Participant Flow|CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
10779494|NCT02120352|FG003|Participant Flow|CAB 30 mg+ABC/3TC QD (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
10779495|NCT02120352|OG000|Outcome|CAB LA 600 mg+RPV LA 900 mg IM-Q8W|In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet once daily in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM. Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV). Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
10779496|NCT02120352|OG001|Outcome|CAB LA 400 mg+RPV LA 600 mg IM-Q4W|In induction period, Participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD for 20 weeks. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM. Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
10964418|NCT00877383|OG001|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10964419|NCT00877383|EG000|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10964420|NCT00877383|EG001|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10779497|NCT02120352|OG002|Outcome|CAB 30 mg+ABC/3TC QD|In induction period, participants received a combination of an oral regimen of CAB 30 mg QD plus ABC/3TC 600/300 mg QD. They also received an oral formulation of RPV 25 mg tablet QD in the last 4 weeks of the induction period. In maintenance period, participants received CAB and ABC/3TC QD for 32 weeks.
10779498|NCT02120352|OG000|Outcome|CAB 30 mg+ABC/3TC QD (Induction Period)|In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
10779499|NCT02120352|OG000|Outcome|CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
10779500|NCT02120352|OG001|Outcome|CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
11339737|NCT03636061|EG000|Reported Event|OC-01 Low Dose, 0.12 mg/mL|OC-01 0.12 mg/ml nasal spray
11339738|NCT03636061|EG001|Reported Event|OC-01 Mid Dose, 0.6 mg/mL|OC-01 0.6 mg/ml nasal spray
11339739|NCT03636061|EG002|Reported Event|OC-01 High Dose, 1.2 mg/mL|OC-01 1.2 mg/ml nasal spray
10779501|NCT02120352|OG002|Outcome|CAB 30 mg+ABC/3TC QD (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
10779502|NCT02120352|OG000|Outcome|CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
10779503|NCT02120352|EG000|Reported Event|CAB 30 mg+ABC/3TC QD (Induction Period)|In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
10779504|NCT02120352|EG001|Reported Event|CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 32 weeks.
10779505|NCT02120352|EG002|Reported Event|CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 32 weeks.
10779506|NCT02120352|EG003|Reported Event|CAB 30 mg+ABC/3TC QD (Maintenance Period)|On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 32 weeks.
10779507|NCT02114814|BG000|Baseline|Family-based Diabetes Intervention|The family-based intervention consisted of eight weekly group sessions for participants with diabetes and family members and two sessions (baseline and T4) with the family for data collection.
10779508|NCT02114814|BG001|Baseline|Attention Control|Participants and their family members in the attention control group received eight weekly group sessions on general health information and two sessions with the family for data collection in addition to usual care.
10779509|NCT02114814|BG002|Baseline|Total|Total of all reporting groups
10779510|NCT02114814|FG000|Participant Flow|Intervention|A Family-Based Diabetes Self-Management Intervention
11339740|NCT03636061|EG003|Reported Event|Placebo|Vehicle nasal spray
10779511|NCT02114814|FG001|Participant Flow|Attention Control|General Health Education
10779512|NCT02114814|OG000|Outcome|Intervention|Diabetes Self-Management
10779513|NCT02114814|OG001|Outcome|Attention Control|General Health education
10779514|NCT02114814|OG000|Outcome|Intervention Group|"Diabetes self-management and family support~Diabetes self-management program for Hispanics and their families: The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish"
10779515|NCT02114814|OG001|Outcome|Attention Control Group|"General health information~General health educational program for Hispanics and their families: The attention control group received 8-weekly education program on general health information"
10779516|NCT02114814|OG000|Outcome|Intervention|A Family-Based Diabetes Self-Management Intervention
10779517|NCT02114814|OG001|Outcome|Attention Control|General Health Education
10779518|NCT02114814|EG000|Reported Event|Intervention|Family-based diabetes self-management
10779519|NCT02114814|EG001|Reported Event|Attention Control|General health education
10779520|NCT02067819|BG000|Baseline|Active Oral Orthotic Treatment|"Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.~Active Oral Orthotic Treatment: Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779521|NCT02067819|BG001|Baseline|Placebo Oral Orthotic Treatment|"Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study.~Placebo Oral Orthotic Treatment: After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779522|NCT02067819|BG002|Baseline|Total|Total of all reporting groups
10779523|NCT02067819|FG000|Participant Flow|Active Oral Orthotic Treatment|"Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.~Active Oral Orthotic Treatment: Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779524|NCT02067819|FG001|Participant Flow|Placebo Oral Orthotic Treatment|"Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study.~Placebo Oral Orthotic Treatment: After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10803693|NCT02492165|FG002|Participant Flow|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10803694|NCT02492165|FG003|Participant Flow|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779525|NCT02067819|OG000|Outcome|Active Oral Orthotic Treatment|"Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.~Active Oral Orthotic Treatment: Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779526|NCT02067819|OG001|Outcome|Placebo Oral Orthotic Treatment|"Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study.~Placebo Oral Orthotic Treatment: After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779527|NCT02067819|EG000|Reported Event|Active Oral Orthotic Treatment|"Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.~Active Oral Orthotic Treatment: Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779528|NCT02067819|EG001|Reported Event|Placebo Oral Orthotic Treatment|"Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study.~Placebo Oral Orthotic Treatment: After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study."
10779529|NCT02004691|BG000|Baseline|Placebo|Participants received intravenous (IV) infusion of placebo (matched to olipudase alfa) once every 2 weeks during the 52 weeks of primary analysis period (PAP). Participants who completed PAP entered in extension treatment period (ETP) and crossed over to olipudase alfa with a target maintenance dose of 3 milligram per kilogram (mg/kg) after dose escalation.
10779530|NCT02004691|BG001|Baseline|Olipudase Alfa|Participants received IV infusion of olipudase alfa once every 2 weeks during the 52 weeks of PAP. Each participant underwent a dose escalation according to the following paradigm: 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 52 weeks of PAP. Participants who completed PAP entered in ETP and continued the same treatment in ETP.
10779531|NCT02004691|BG002|Baseline|Total Title|
10779532|NCT02004691|FG000|Participant Flow|Placebo|Participants received intravenous (IV) infusion of placebo (matched to olipudase alfa) once every 2 weeks during the 52 weeks of primary analysis period (PAP). Participants who completed PAP entered in extension treatment period (ETP) and crossed over to olipudase alfa with a target maintenance dose of 3 milligram per kilogram (mg/kg) after dose escalation.
10779533|NCT02004691|FG001|Participant Flow|Olipudase Alfa|Participants received IV infusion of olipudase alfa once every 2 weeks during the 52 weeks of PAP. Each participant underwent a dose escalation according to the following paradigm: 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 52 weeks of PAP. Participants who completed PAP entered in ETP and continued the same treatment in ETP.
11193452|NCT02145156|EG002|Reported Event|Usual Care|"Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
10779534|NCT02004691|OG000|Outcome|Placebo|Participants received intravenous (IV) infusion of placebo (matched to olipudase alfa) once every 2 weeks during the 52 weeks of primary analysis period (PAP). Participants who completed PAP entered in extension treatment period (ETP) and crossed over to olipudase alfa with a target maintenance dose of 3 milligram per kilogram (mg/kg) after dose escalation.
10779535|NCT02004691|OG001|Outcome|Olipudase Alfa|Participants received IV infusion of olipudase alfa once every 2 weeks during the 52 weeks of PAP. Each participant underwent a dose escalation according to the following paradigm: 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 52 weeks of PAP. Participants who completed PAP entered in ETP and continued the same treatment in ETP.
10779536|NCT02004691|EG000|Reported Event|Placebo|Participants received intravenous (IV) infusion of placebo (matched to olipudase alfa) once every 2 weeks during the 52 weeks of primary analysis period (PAP). Participants who completed PAP entered in extension treatment period (ETP) and crossed over to olipudase alfa with a target maintenance dose of 3 milligram per kilogram (mg/kg) after dose escalation.
10779537|NCT02004691|EG001|Reported Event|Olipudase Alfa|Participants received IV infusion of olipudase alfa once every 2 weeks during the 52 weeks of PAP. Each participant underwent a dose escalation according to the following paradigm: 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 52 weeks of PAP. Participants who completed PAP entered in ETP and continued the same treatment in ETP.
10803695|NCT02492165|OG000|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779563|NCT01802632|BG000|Baseline|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
10779564|NCT01802632|BG001|Baseline|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
10779565|NCT01802632|BG002|Baseline|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
10779566|NCT01802632|BG003|Baseline|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
10779567|NCT01802632|BG004|Baseline|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
10779568|NCT01802632|BG005|Baseline|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
10779569|NCT01802632|BG006|Baseline|Total|Total of all reporting groups
10779570|NCT01802632|FG000|Participant Flow|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
10779571|NCT01802632|FG001|Participant Flow|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
10779572|NCT01802632|FG002|Participant Flow|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
10779573|NCT01802632|FG003|Participant Flow|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
10779574|NCT01802632|FG004|Participant Flow|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
10779575|NCT01802632|FG005|Participant Flow|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
10779576|NCT01802632|OG000|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
10779577|NCT01802632|OG000|Outcome|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
10779578|NCT01802632|OG000|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
10779579|NCT01802632|OG000|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
10779580|NCT01802632|EG000|Reported Event|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
10779581|NCT01802632|EG001|Reported Event|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
10779582|NCT01802632|EG002|Reported Event|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
10779583|NCT01802632|EG003|Reported Event|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
10779584|NCT01802632|EG004|Reported Event|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
10779585|NCT01802632|EG005|Reported Event|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
10779586|NCT01668719|BG000|Baseline|Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone)|"INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity."
10779587|NCT01668719|BG001|Baseline|Arm I (Bortezomib, Lenalidomide, Dexamethasone)|"INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779588|NCT01668719|BG002|Baseline|Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)|"INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Elotuzumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779589|NCT01668719|BG003|Baseline|Total|Total of all reporting groups
10779590|NCT01668719|FG000|Participant Flow|Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone)|"INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity."
10803696|NCT02492165|OG001|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779591|NCT01668719|FG001|Participant Flow|Arm I (Bortezomib, Lenalidomide, Dexamethasone)|"INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779592|NCT01668719|FG002|Participant Flow|Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)|"INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Elotuzumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779593|NCT01668719|OG000|Outcome|Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone)|"INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity."
10779594|NCT01668719|OG000|Outcome|Arm I (Bortezomib, Lenalidomide, Dexamethasone)|"INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779595|NCT01668719|OG001|Outcome|Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)|"INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Elotuzumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO"
10779596|NCT01668719|OG000|Outcome|Arm I (Bortezomib, Lenalidomide, Dexamethasone)|"INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Lenalidomide: Given PO"
10779597|NCT01668719|OG001|Outcome|Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)|"INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Elotuzumab: Given IV~Lenalidomide: Given PO"
10964421|NCT00877448|BG000|Baseline|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
10964422|NCT00877448|BG001|Baseline|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
10964423|NCT00877448|BG002|Baseline|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
11193453|NCT02145182|BG000|Baseline|Eculizumab|Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Eculizumab was administered by IV infusion over 25 to 45 min for each dose. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
11193454|NCT02145182|BG001|Baseline|Placebo|Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Placebo was administered by IV infusion over 25 to 45 min for each dose. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
11193455|NCT02145182|BG002|Baseline|Total|Total of all reporting groups
11193456|NCT02145182|FG000|Participant Flow|Eculizumab|Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by intravenous (IV) infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
11193457|NCT02145182|FG001|Participant Flow|Placebo|Participants received 2 doses of placebo (0.9% sodium chloride [NaCl]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
11193458|NCT02145182|OG000|Outcome|Eculizumab|Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
11193459|NCT02145182|OG001|Outcome|Placebo|Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
10779598|NCT01668719|EG000|Reported Event|Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenali|"INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity."
10779599|NCT01668719|EG001|Reported Event|Arm I (Bortezomib, Lenalidomide, Dexamethasone)|"INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).~MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Lenalidomide: Given PO"
10779600|NCT01668719|EG002|Reported Event|Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)|"INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given SC or IV~Dexamethasone: Given PO or IV~Elotuzumab: Given IV~Lenalidomide: Given PO"
10779601|NCT01625286|BG000|Baseline|Part A Schedule 1 560 mg bd|Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779602|NCT01625286|BG001|Baseline|Part A Schedule 1 640 mg bd|Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
11193460|NCT02145182|EG000|Reported Event|Eculizumab|Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
11193461|NCT02145182|EG001|Reported Event|Placebo|Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
10779603|NCT01625286|BG002|Baseline|Part A Schedule 2 360 mg bd|Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10964424|NCT00877448|BG003|Baseline|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
10779604|NCT01625286|BG003|Baseline|Part A Schedule 2 400 mg bd|Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779605|NCT01625286|BG004|Baseline|Part A Schedule 2 480 mg bd|Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779606|NCT01625286|BG005|Baseline|Part B AZD5363|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779607|NCT01625286|BG006|Baseline|Part B Placebo|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779608|NCT01625286|BG007|Baseline|Total|Total of all reporting groups
10779609|NCT01625286|FG000|Participant Flow|Part A Schedule 1 560 mg bd|Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779610|NCT01625286|FG001|Participant Flow|Part A Schedule 1 640 mg bd|Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779611|NCT01625286|FG002|Participant Flow|Part A Schedule 2 360 mg bd|Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779612|NCT01625286|FG003|Participant Flow|Part A Schedule 2 400 mg bd|Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779613|NCT01625286|FG004|Participant Flow|Part A Schedule 2 480 mg bd|Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779614|NCT01625286|FG005|Participant Flow|Part B AZD5363|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779615|NCT01625286|FG006|Participant Flow|Part B Placebo|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779616|NCT01625286|OG000|Outcome|Part A Schedule 1 560 mg bd|Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779617|NCT01625286|OG001|Outcome|Part A Schedule 1 640 mg bd|Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779618|NCT01625286|OG002|Outcome|Part A Schedule 2 360 mg bd|Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779619|NCT01625286|OG003|Outcome|Part A Schedule 2 400 mg bd|Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779620|NCT01625286|OG004|Outcome|Part A Schedule 2 480 mg bd|Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779621|NCT01625286|OG005|Outcome|Part B AZD5363|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779622|NCT01625286|OG006|Outcome|Part B Placebo|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
11193462|NCT02145247|BG000|Baseline|Normal Adult Women|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11193463|NCT02145247|BG001|Baseline|Women With PCOS|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11193464|NCT02145247|BG002|Baseline|Total|Total of all reporting groups
11193465|NCT02145247|FG000|Participant Flow|Normal Adult Women|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
10779623|NCT01625286|EG000|Reported Event|Part A Schedule 1 560 mg bd|Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779624|NCT01625286|EG001|Reported Event|Sched 1 - AZD5363 640 mg bd|(2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779625|NCT01625286|EG002|Reported Event|Sched 2 - AZD5363 360 mg bd|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779626|NCT01625286|EG003|Reported Event|Sched 2 - AZD5363 400 mg bd|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779627|NCT01625286|EG004|Reported Event|Part A Schedule 2 480 mg bd|Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
10779628|NCT01625286|EG005|Reported Event|Part B AZD5363|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779629|NCT01625286|EG006|Reported Event|Part B Placebo|(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
10779630|NCT01515748|BG000|Baseline|Surgery + Adjuvant Chemotherapy (SC)|Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779631|NCT01515748|BG001|Baseline|Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)|Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779632|NCT01515748|BG002|Baseline|Total|Total of all reporting groups
10803697|NCT02492165|OG002|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10803698|NCT02492165|OG003|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779633|NCT01515748|FG000|Participant Flow|Surgery + Adjuvant Chemotherapy (SC)|Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 milligrams per square meter (mg/m^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779634|NCT01515748|FG001|Participant Flow|Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)|Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779635|NCT01515748|OG000|Outcome|Surgery + Adjuvant Chemotherapy (SC)|Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779636|NCT01515748|OG001|Outcome|Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)|Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779637|NCT01515748|OG000|Outcome|Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)|Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779638|NCT01515748|EG000|Reported Event|Surgery + Adjuvant Chemotherapy (SC)|Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10803699|NCT02492165|EG000|Reported Event|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10964425|NCT00877448|BG004|Baseline|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
11193466|NCT02145247|FG001|Participant Flow|Women With PCOS|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11193467|NCT02145247|OG000|Outcome|Normal Adult Women|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11193468|NCT02145247|OG001|Outcome|Women With PCOS|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11339756|NCT03636893|OG001|Outcome|SOX Chemotherapy Regimen|"Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered~A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)~Repeated every 21st day~Two drug Chemotherapy: Oxaliplatin+TGO"
10779639|NCT01515748|EG001|Reported Event|Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)|Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).
10779640|NCT01261247|BG000|Baseline|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10779641|NCT01261247|FG000|Participant Flow|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10779642|NCT01261247|OG000|Outcome|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10779643|NCT01261247|EG000|Reported Event|Arm I (LBH589)|Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10779644|NCT01169259|BG000|Baseline|ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10779645|NCT01169259|BG001|Baseline|ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
10779646|NCT01169259|BG002|Baseline|PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10779647|NCT01169259|BG003|Baseline|PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
10779648|NCT01169259|BG004|Baseline|Total|Total of all reporting groups
11339757|NCT03636893|EG000|Reported Event|FLOT Chemotherpy Regimen|"A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered~A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous~Repeated every 15th day~Three drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin"
10779649|NCT01169259|FG000|Participant Flow|ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10779650|NCT01169259|FG001|Participant Flow|ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids|ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
10779651|NCT01169259|FG002|Participant Flow|PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10779652|NCT01169259|FG003|Participant Flow|PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids|PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
10779653|NCT01169259|OG000|Outcome|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day
10779654|NCT01169259|OG001|Outcome|Vitamin D Placebo|Vitamin D placebo, one capsule/day
10779655|NCT01169259|OG002|Outcome|Active Omega-3 Fatty Acids|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
10779656|NCT01169259|OG003|Outcome|Omega-3 Fatty Acids Placebo|Omega-3 fatty acids placebo, one capsule/day
10779657|NCT01169259|OG000|Outcome|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day.
10779658|NCT01169259|OG001|Outcome|VItamin D Placebo|VItamin D placebo, one capsule/day
10779659|NCT01169259|EG000|Reported Event|Active Vitamin D|Vitamin D3, one 2000 IU capsule/day
10779660|NCT01169259|EG001|Reported Event|Vitamin D Placebo|Vitamin D placebo, one capsule/day
10779661|NCT01169259|EG002|Reported Event|Active Omega-3 Fatty Acids|Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
10779662|NCT01169259|EG003|Reported Event|Omega-3 Fatty Acids Placebo|Omega-3 fatty acids placebo, one capsule/day
10779663|NCT01169259|EG004|Reported Event|Active Vitamin D/Active Omega-3 Fatty Acids|Vitamin D3 (one 2000 IU capsule/day) + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
10779664|NCT01169259|EG005|Reported Event|Active Vitamin D/Placebo Omega-3 Fatty Acids|Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day
10779665|NCT01169259|EG006|Reported Event|Placebo Vitamin D/Active Omega-3 Fatty Acids|Vitamin D placebo, one capsule/day + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
10779666|NCT01169259|EG007|Reported Event|Placebo Vitamin D/Placebo Omega-3 Fatty Acids|Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day
10779667|NCT00790933|BG000|Baseline|Vedolizumab 300 mg (C13006)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52.
10803700|NCT02492165|EG001|Reported Event|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779668|NCT00790933|BG001|Baseline|Vedolizumab 300 mg (C13007)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
10779669|NCT00790933|BG002|Baseline|Vedolizumab 300 mg (C13011)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
10779670|NCT00790933|BG003|Baseline|Vedolizumab 300 mg (C13004)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
10779671|NCT00790933|BG004|Baseline|Vedolizumab 300 mg (C13008 De Novo Participants)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
10779672|NCT00790933|BG005|Baseline|Total|Total of all reporting groups
10779673|NCT00790933|FG000|Participant Flow|Vedolizumab 300 mg (C13006)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.
10779674|NCT00790933|FG001|Participant Flow|Vedolizumab 300 mg (C13007)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
11193469|NCT02145247|EG000|Reported Event|Normal Adult Women|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11193470|NCT02145247|EG001|Reported Event|Women With PCOS|"Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.~On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained at T = -0.5, 0, and +24 hours.~Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.~One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.~hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
11339758|NCT03636893|EG001|Reported Event|SOX Chemotherapy Regimen|"Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered~A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)~Repeated every 21st day~Two drug Chemotherapy: Oxaliplatin+TGO"
10779675|NCT00790933|FG002|Participant Flow|Vedolizumab 300 mg (C13011)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
10779676|NCT00790933|FG003|Participant Flow|Vedolizumab 300 mg (C13004)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
10779677|NCT00790933|FG004|Participant Flow|Vedolizumab 300 mg (C13008 De Novo Participants)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
10779678|NCT00790933|OG000|Outcome|Vedolizumab 300 mg (UC)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).
10779679|NCT00790933|OG001|Outcome|Vedolizumab 300 mg (CD)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.
10779680|NCT00790933|OG000|Outcome|Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks.
10779681|NCT00790933|OG000|Outcome|Vedolizumab 300 mg (C13006 Placebo)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
10779682|NCT00790933|OG001|Outcome|Vedolizumab 300 mg (C13006 Vedolizumab Q8W)|"Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.~In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50."
10803701|NCT02492165|EG002|Reported Event|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10779683|NCT00790933|OG002|Outcome|Vedolizumab 300 mg (C13006 Vedolizumab Q4W)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
10779684|NCT00790933|OG003|Outcome|Vedolizumab 300 mg (C13007 Placebo)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
10779685|NCT00790933|OG004|Outcome|Vedolizumab 300 mg (C13007 Vedolizumab Q8W)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
10779686|NCT00790933|OG005|Outcome|Vedolizumab 300 mg (C13007 Vedolizumab Q4W)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
10779687|NCT00790933|OG006|Outcome|Vedolizumab 300 mg (C13011 Placebo)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
10779688|NCT00790933|OG007|Outcome|Vedolizumab 300 mg (C13011 Vedolizumab)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
10779689|NCT00790933|OG008|Outcome|Vedolizumab 300 mg (C13008 De Novo Participants - UC)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
10779690|NCT00790933|OG009|Outcome|Vedolizumab 300 mg (C13008 De Novo Participants - CD)|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
10779691|NCT00790933|EG000|Reported Event|Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13006, C13007 and C13011.
10779692|NCT00624234|BG000|Baseline|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779693|NCT00624234|BG001|Baseline|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779694|NCT00624234|BG002|Baseline|Typically Developing Readers|Control group--children who do not have reading problems
10779695|NCT00624234|BG003|Baseline|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779696|NCT00624234|BG004|Baseline|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779697|NCT00624234|BG005|Baseline|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
10779698|NCT00624234|BG006|Baseline|Total|Total of all reporting groups
10779699|NCT00624234|FG000|Participant Flow|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10803702|NCT02492165|EG003|Reported Event|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10964426|NCT00877448|BG005|Baseline|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
11379103|NCT03809663|OG003|Outcome|Part A: Tezepelumab 420 mg Q2W|"Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379104|NCT03809663|OG000|Outcome|Part A: Tezepelumab 210 mg Q4W|"Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379105|NCT03809663|OG001|Outcome|Part A: Tezepelumab 280 mg Q2W|"Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.~All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379106|NCT03809663|OG002|Outcome|Part A: Tezepelumab 420 mg Q2W|"Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.~Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study."
11379107|NCT03809663|OG000|Outcome|Part A: Placebo up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)|"All participants who received the matching placebo Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52.~Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52."
11379108|NCT03809663|OG001|Outcome|Part A: Tezepelumab 210 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)|"All participants who received tezepelumab 210 mg Q4W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers).~Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52."
11379109|NCT03809663|OG002|Outcome|Part A: Tezepelumab 280 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)|"All participants who received tezepelumab 280 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers).~Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52."
11379110|NCT03809663|OG003|Outcome|Part A: Tezepelumab 420 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)|"All participants who received tezepelumab 420 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and continued to receive tezepelumab 420 mg Q2W up to Week 52.~Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52."
11379111|NCT03809663|EG000|Reported Event|Placebo|Participants who took placebo from Week 1 to Week 16.
11379112|NCT03809663|EG001|Reported Event|Tezepelumab 210 mg Q4W|Participants who took 210 mg Q4W from Week 1 to Week 16.
11379113|NCT03809663|EG002|Reported Event|Tezepelumab 280 mg Q2W|Participants who took 280 mg Q2W from Week 1 to Week 16.
11379114|NCT03809663|EG003|Reported Event|Tezepelumab 420 mg Q2W|"Participants who took 420 mg Q2W from Week 1 to Week 16.~Includes 7 subjects randomized to the lower doses of Tezepelumab but received only the first dose of Tezepelumab 420 mg SC and early discontinued."
11379115|NCT03809663|EG004|Reported Event|Placebo - Placebo|Non-switching participants who took placebo from Week 16 to Week 52.
11379116|NCT03809663|EG005|Reported Event|Tezepelumab 210 mg Q4W - 210 mg Q4W|Non-switching participants who took 210 mg Q4W from Week 16 to Week 52.
11379117|NCT03809663|EG006|Reported Event|Tezepelumab 280 mg Q2W - 280 mg Q2W|Non-switching participants who took 280 mg Q2W from Week 16 to Week 52.
11379118|NCT03809663|EG007|Reported Event|Tezepelumab 420 mg Q2W - 420 mg Q2W|"Non-switching participants who continued to take 420 mg Q2W from Week 16 to Week 52.~Includes 6 participants who were randomized to placebo (n=2), 210 mg Q4W (n=3) and 280 mg Q2W (n=1) but switched to Tezepelumab 420 mg SC Q2W in error after Week 16."
11379119|NCT03809663|EG008|Reported Event|Placebo- Tezepelumab 420 mg Q2W|Participants who switched after Week 16 to take 420 mg Q2W.
11379120|NCT03809663|EG009|Reported Event|Tezepelumab 210 mg Q4W-420 mg Q2W|Participants who switched after Week 16 to take 420 mg Q2W.
10803703|NCT02476006|BG000|Baseline|Alirocumab|Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
11379121|NCT03809663|EG010|Reported Event|Tezepelumab 280 mg Q2W-420 mg Q2W|Participants who switched after Week 16 to take 420 mg Q2W.
11379122|NCT03809663|EG011|Reported Event|Tezepelumab 420 mg Q2W-420 mg Q2W|Participants who switched after week 16 who continued to take 420 mg Q2W.
11379123|NCT03782792|BG000|Baseline|Placebo|Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
10964427|NCT00877448|BG006|Baseline|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
10964428|NCT00877448|BG007|Baseline|Total|Total of all reporting groups
10779700|NCT00624234|FG001|Participant Flow|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779701|NCT00624234|FG002|Participant Flow|Typically Developing Readers|Control group--children who do not have reading problems
10779702|NCT00624234|FG003|Participant Flow|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779703|NCT00624234|FG004|Participant Flow|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779704|NCT00624234|FG005|Participant Flow|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
10779705|NCT00624234|OG000|Outcome|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779706|NCT00624234|OG001|Outcome|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779707|NCT00624234|OG002|Outcome|Typically Developing Readers|Control group--children who do not have reading problems
10779708|NCT00624234|OG003|Outcome|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779709|NCT00624234|OG004|Outcome|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779710|NCT00624234|OG005|Outcome|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
10779711|NCT00624234|EG000|Reported Event|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
10779712|NCT00624234|EG001|Reported Event|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
10779713|NCT00624234|EG002|Reported Event|Typically Developing Readers|Control group--children who do not have reading problems
10779714|NCT00624234|EG003|Reported Event|IRD-Tutoring Program 1|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
10779715|NCT00624234|EG004|Reported Event|IRD-Tutoring Program 2|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
10779716|NCT00624234|EG005|Reported Event|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
10779740|NCT00127673|BG000|Baseline|NoChoice_CBT|"Participants will receive no choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779741|NCT00127673|BG001|Baseline|Choice_CBT|"Participants will receive choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779742|NCT00127673|BG002|Baseline|NoChoice_SER|"Participants will receive no choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779743|NCT00127673|BG003|Baseline|Choice_SER|"Participants will receive choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779744|NCT00127673|BG004|Baseline|Total|Total of all reporting groups
10779745|NCT00127673|FG000|Participant Flow|NoChoice_CBT|"Participants will receive no choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779746|NCT00127673|FG001|Participant Flow|Choice_CBT|"Participants will receive choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779747|NCT00127673|FG002|Participant Flow|NoChoice_SER|"Participants will receive no choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779748|NCT00127673|FG003|Participant Flow|Choice_SER|"Participants will receive choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779749|NCT00127673|OG000|Outcome|CBT no Choice|"Participants will receive no choice cognitive behavioral therapy (CBT no choice)~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779750|NCT00127673|OG001|Outcome|CBT Choice|"Participants will receive choice cognitive behavioral therapy (CBT choice)~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779751|NCT00127673|OG002|Outcome|Sertraline no Choice|"Participants will receive no choice sertraline (sertraline no choice)~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779752|NCT00127673|OG003|Outcome|Sertraline Choice|"Participants will receive choice sertraline (sertraline choice)~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779753|NCT00127673|OG000|Outcome|NoChoice_CBT|"Participants will receive no choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779754|NCT00127673|OG001|Outcome|Choice_CBT|"Participants will receive choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779755|NCT00127673|OG002|Outcome|NoChoice_SER|"Participants will receive no choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779756|NCT00127673|OG003|Outcome|Choice_SER|"Participants will receive choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779757|NCT00127673|EG000|Reported Event|NoChoice_CBT|"Participants will receive no choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779758|NCT00127673|EG001|Reported Event|Choice_CBT|"Participants will receive choice cognitive behavioral therapy~Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."
10779759|NCT00127673|EG002|Reported Event|NoChoice_SER|"Participants will receive no choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10779760|NCT00127673|EG003|Reported Event|Choice_SER|"Participants will receive choice sertraline~Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."
10801110|NCT02573493|EG003|Reported Event|Arm 1 CRT: Cisplatin + Radiation Therapy|"CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.~It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801111|NCT02573493|EG004|Reported Event|Arm 1 & 2 ERT: Cetuximab + Radiation Therapy|"CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.~It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk."
10801112|NCT02573493|EG005|Reported Event|Arm 3 CR: Cisplatin + Radiation Therapy|"CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy~Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study."
10801113|NCT02573493|EG006|Reported Event|Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up|-Follow-up time period of up to 72 months post-completion of therapy
10801114|NCT02573493|EG007|Reported Event|Arm 2: Nab-Paclitaxel + ERT Follow-up|-Follow-up time period of up to 72 months post-completion of therapy
10801115|NCT02573493|EG008|Reported Event|Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up|-Follow-up time period of up to 72 months post-completion of therapy
10801116|NCT02414607|BG000|Baseline|Elderberry Juice|"Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.~Elderberry Juice"
10801117|NCT02414607|BG001|Baseline|Placebo|"Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.~Placebo"
10801118|NCT02414607|BG002|Baseline|Total|Total of all reporting groups
10801119|NCT02414607|FG000|Participant Flow|Elderberry Juice|"Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.~Elderberry Juice"
10801120|NCT02414607|FG001|Participant Flow|Placebo|"Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.~Placebo"
10801121|NCT02414607|OG000|Outcome|Elderberry Juice|"Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.~Elderberry Juice"
10801122|NCT02414607|OG001|Outcome|Placebo|"Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.~Placebo"
10801123|NCT02414607|EG000|Reported Event|Elderberry Juice|"Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.~Elderberry Juice"
10801124|NCT02414607|EG001|Reported Event|Placebo|"Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.~Placebo"
10779761|NCT04388527|BG000|Baseline|Treatment|"Penn COVID-19 convalescent plasma~COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19."
10779762|NCT04388527|FG000|Participant Flow|Treatment|"Penn COVID-19 convalescent plasma~COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19."
10779763|NCT04388527|OG000|Outcome|Treatment|"Penn COVID-19 convalescent plasma~COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19."
10779764|NCT04388527|EG000|Reported Event|Treatment|"Penn COVID-19 convalescent plasma~COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19."
10779765|NCT04369833|BG000|Baseline|Continuous Glucose Monitoring Group|"all participants wearing a continuous glucose monitoring device~continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)"
10779766|NCT04369833|FG000|Participant Flow|Continuous Glucose Monitoring Group|"all participants wearing a continuous glucose monitoring device~continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)"
10779767|NCT04369833|OG000|Outcome|Continuous Glucose Monitoring Group|"all participants wearing a continuous glucose monitoring device~continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)"
10779768|NCT04369833|EG000|Reported Event|Continuous Glucose Monitoring Group|"all participants wearing a continuous glucose monitoring device~continuous glucose monitoring system: wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)"
10964429|NCT00877448|FG000|Participant Flow|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
10779769|NCT04280081|BG000|Baseline|Selpercatinib|160 mg Selpercatinib administered orally BID.
10779770|NCT04280081|FG000|Participant Flow|Selpercatinib|160 milligram (mg) Selpercatinib administered orally twice daily (BID).
10779771|NCT04280081|OG000|Outcome|RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1|160 mg Selpercatinib administered orally BID.
10779772|NCT04280081|OG001|Outcome|RET Fusion Positive Thyroid Cancer (TC) Cohort 1|160 mg Selpercatinib administered orally BID.
10779773|NCT04280081|OG002|Outcome|RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2|160 mg Selpercatinib administered orally BID.
10779774|NCT04280081|OG000|Outcome|Non-small Cell Lung Cancer (All NSCLC)|160 mg Selpercatinib administered orally BID.
10779775|NCT04280081|OG001|Outcome|Thyroid Cancer (All TC)|160 mg Selpercatinib administered orally BID.
10779776|NCT04280081|OG002|Outcome|Medullary Thyroid Cancer (All MTC)|160 mg Selpercatinib administered orally BID.
10779777|NCT04280081|OG000|Outcome|All NSCLC|160 mg Selpercatinib administered orally BID.
10779778|NCT04280081|OG001|Outcome|All TC|160 mg Selpercatinib administered orally BID.
10779779|NCT04280081|OG002|Outcome|All MTC|160 mg Selpercatinib administered orally BID.
10779780|NCT04280081|OG000|Outcome|Selpercatinib|160 mg Selpercatinib administered orally BID.
10779781|NCT04280081|EG000|Reported Event|Selpercatinib|160 mg Selpercatinib administered orally twice daily (BID).
10779782|NCT04238429|BG000|Baseline|Toothpaste Containing Effective Ingredients|"Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks~Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779783|NCT04238429|BG001|Baseline|Negative Control Toothpaste|"Use the negative control dentifrice to brush teeth twice daily for 8 weeks~Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779784|NCT04238429|BG002|Baseline|Total|Total of all reporting groups
10779785|NCT04238429|FG000|Participant Flow|Toothpaste Containing Effective Ingredients|"Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks~Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779786|NCT04238429|FG001|Participant Flow|Negative Control Toothpaste|"Use the negative control dentifrice to brush teeth twice daily for 8 weeks~Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779787|NCT04238429|OG000|Outcome|Toothpaste Containing Effective Ingredients|"Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks~Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779788|NCT04238429|OG001|Outcome|Negative Control Toothpaste|"Use the negative control dentifrice to brush teeth twice daily for 8 weeks~Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779789|NCT04238429|EG000|Reported Event|Toothpaste Containing Effective Ingredients|"Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks~Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks"
10779790|NCT04238429|EG001|Reported Event|Negative Control Toothpaste|"Use the negative control dentifrice to brush teeth twice daily for 8 weeks~Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks"
10801125|NCT02279173|BG000|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
10964430|NCT00877448|FG001|Participant Flow|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
10964431|NCT00877448|FG002|Participant Flow|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
10779791|NCT04126083|BG000|Baseline|Lofexidine|"Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.~Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily"
10779792|NCT04126083|FG000|Participant Flow|Lofexidine|"Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.~Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily"
10779793|NCT04126083|OG000|Outcome|Lofexidine|"Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.~Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily"
10779794|NCT04126083|EG000|Reported Event|Lofexidine|"Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.~Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily"
10779795|NCT03901300|BG000|Baseline|Fundamental Motor Skills (FMS)|"The FMS group will utilize the PLAY FMS app that provides instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to the child over a 12 week period.~Fundamental Motor Skills App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group."
10779796|NCT03901300|BG001|Baseline|Unstructured Physical Activity|"The active comparator group will use a version of the PLAY app that provides instructional lessons to promote the equivalent dosage of unstructured physical activity for the child.~Unstructured Physical Activity App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group."
10779797|NCT03901300|BG002|Baseline|Total|Total of all reporting groups
10779798|NCT03901300|FG000|Participant Flow|Fundamental Motor Skills (FMS)|"The FMS group will utilize the PLAY FMS app that provides instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to the child over a 12 week period.~Fundamental Motor Skills App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group."
10779799|NCT03901300|FG001|Participant Flow|Unstructured Physical Activity|"The active comparator group will use a version of the PLAY app that provides instructional lessons to promote the equivalent dosage of unstructured physical activity for the child.~Unstructured Physical Activity App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group."
10779800|NCT03901300|OG000|Outcome|Fundamental Motor Skills (FMS)|"The FMS group will utilize the PLAY FMS app that provides instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to the child over a 12 week period.~Fundamental Motor Skills App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group."
10779801|NCT03901300|OG001|Outcome|Unstructured Physical Activity|"The active comparator group will use a version of the PLAY app that provides instructional lessons to promote the equivalent dosage of unstructured physical activity for the child.~Unstructured Physical Activity App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group."
10779802|NCT03901300|EG000|Reported Event|Fundamental Motor Skills (FMS)|"The FMS group will utilize the PLAY FMS app that provides instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to the child over a 12 week period.~Fundamental Motor Skills App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group."
10779803|NCT03901300|EG001|Reported Event|Unstructured Physical Activity|"The active comparator group will use a version of the PLAY app that provides instructional lessons to promote the equivalent dosage of unstructured physical activity for the child.~Unstructured Physical Activity App: Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group."
10779804|NCT03744637|BG000|Baseline|MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779805|NCT03744637|BG001|Baseline|MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779806|NCT03744637|BG002|Baseline|MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779807|NCT03744637|BG003|Baseline|Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).
10779808|NCT03744637|BG004|Baseline|Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A)|Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).
10779809|NCT03744637|BG005|Baseline|MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B)|Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).
10779810|NCT03744637|BG006|Baseline|MK-5475 300 ug/ MK-5475 360 ug/ MK-5475 360 ug (Panels B+C)|Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 360 ug (Part 2 Period 2), and 360 ug (Part 2 Period 3).
10779811|NCT03744637|BG007|Baseline|MK-5475 300 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel C)|Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
10779812|NCT03744637|BG008|Baseline|MK-5475 480 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel D)|Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
10779813|NCT03744637|BG009|Baseline|MK-5475 480 ug/ MK-5475 120 ug (Panel D)|Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).
10779814|NCT03744637|BG010|Baseline|Total|Total of all reporting groups
10779815|NCT03744637|FG000|Participant Flow|MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779816|NCT03744637|FG001|Participant Flow|MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779817|NCT03744637|FG002|Participant Flow|MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
10779818|NCT03744637|FG003|Participant Flow|Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)|Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).
10779819|NCT03744637|FG004|Participant Flow|Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A)|Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).
10779820|NCT03744637|FG005|Participant Flow|MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B)|Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).
10779821|NCT03744637|FG006|Participant Flow|MK-5475 300 ug/ MK-5475 360 ug/ MK-5475 360 ug (Panels B+C)|Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 360 ug (Part 2 Period 2), and 360 ug (Part 2 Period 3).
10779822|NCT03744637|FG007|Participant Flow|MK-5475 300 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel C)|Participants received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
10779823|NCT03744637|FG008|Participant Flow|MK-5475 480 ug/ MK-5475 120 ug/ MK-5475 120 ug (Panel D)|Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
10779824|NCT03744637|FG009|Participant Flow|MK-5475 480 ug/ MK-5475 120 ug (Panel D)|Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).
10779825|NCT03744637|OG000|Outcome|MK-5475 120 ug: Part 1 (Panel A)|Participants received MK-5475 120 ug during Part 1.
10779826|NCT03744637|OG001|Outcome|MK-5475 165 ug: Part 1 (Panel A)|Participants received MK-5475 165 ug during Part 1.
10779827|NCT03744637|OG002|Outcome|MK-5475 240 ug: Part 1 (Panel A)|Participants received MK-5475 240 ug during Part 1.
10779828|NCT03744637|OG003|Outcome|MK-5475 300 ug: Part 2 Period 1 (Panels B+C)|Participants received MK-5475 300 ug during Part 2 Period 1.
10779829|NCT03744637|OG004|Outcome|MK-5475 480 ug: Part 2 Period 1 (Panel D)|Participants received MK-5475 480 ug during Part 2 Period 1.
10779830|NCT03744637|OG005|Outcome|Placebo: Part 1|Participants received placebo during Part 1.
10779831|NCT03744637|OG006|Outcome|MK-5475 120 ug: RHC (Panel D)|Participants received MK-5475 120 ug during the RHC Period.
10779832|NCT03744637|OG007|Outcome|MK-5475 165 ug: RHC (Panel B)|Participant received MK-5475 165 ug during the RHC Period.
10779833|NCT03744637|OG008|Outcome|MK-5475 240 ug: RHC (Panel A)|Participants received MK-5475 240 ug during the RHC Period.
10779834|NCT03744637|OG009|Outcome|MK-5475 360 ug: RHC (Panels B+C)|Participants received MK-5475 360 ug during the RHC Period.
10779835|NCT03744637|OG010|Outcome|MK-5475 120 ug: FRI (Panels C+D)|Participants received MK-5475 120 ug during the FRI Period.
10779836|NCT03744637|OG011|Outcome|MK-5475 165 ug: FRI (Panel B)|Participant received MK-5475 165 ug during the FRI Period.
10779837|NCT03744637|OG012|Outcome|MK-5475 240 ug: FRI (Panel A)|Participants received MK-5475 240 ug during the FRI Period.
10779838|NCT03744637|OG013|Outcome|MK-5475 360 ug: FRI (Panels B+C)|Participants received MK-5475 360 ug during the FRI Period.
10779839|NCT03744637|OG000|Outcome|MK-5475 120 ug: Part 1|Participants received MK-5475 120 ug during Part 1.
10779840|NCT03744637|OG001|Outcome|MK-5475 165 ug: Part 1|Participants received MK-5475 165 ug during Part 1.
10779841|NCT03744637|OG002|Outcome|MK-5475 240 ug: Part 1|Participants received MK-5475 240 ug during Part 1.
10779842|NCT03744637|OG003|Outcome|MK-5475 300 ug: Part 2 Period 1|Participants received MK-5475 300 ug during Part 2 Period 1.
10779843|NCT03744637|OG004|Outcome|MK-5475 480 ug: Part 2 Period 1|Participants received MK-5475 480 ug during Part 2 Period 1.
10779844|NCT03744637|OG009|Outcome|MK-5475 360 ug: RHC (Panel B)|Participants in Panel B received MK-5475 360 ug during the RHC Period.
10779845|NCT03744637|OG010|Outcome|MK-5475 360 ug: RHC (Panel C)|Participants in Panel C received MK-5475 360 ug during the RHC Period.
10779846|NCT03744637|OG011|Outcome|MK-5475 120 ug: FRI|Participants received MK-5475 120 ug during the FRI Period.
10779847|NCT03744637|OG012|Outcome|MK-5475 165 ug: FRI (Panel B)|Participant received MK-5475 165 ug during the FRI Period.
10779848|NCT03744637|OG013|Outcome|MK-5475 240 ug: FRI|Participants received MK-5475 240 ug during the FRI Period.
10779849|NCT03744637|OG014|Outcome|MK-5475 360 ug: FRI|Participants received MK-5475 360 ug during the FRI Period.
10779850|NCT03744637|OG007|Outcome|MK-5475 165 ug: RHC (Panel B)|Participants received MK-5475 165 ug during the RHC Period.
10779851|NCT03744637|OG000|Outcome|MK-5475 120 ug: Part 1 (Panel A)|Participants in Panel A received MK-5475 120 ug during Part 1.
10779852|NCT03744637|OG001|Outcome|MK-5475 165 ug: Part 1 (Panel A)|Participants in Panel A received MK-5475 165 ug during Part 1.
10779853|NCT03744637|OG002|Outcome|MK-5475 240 ug: Part 1 (Panel A)|Participants in Panel A received MK-5475 240 ug during Part 1.
10779854|NCT03744637|OG003|Outcome|MK-5475 300 ug: Part 2 Period 1 (Panel B)|Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
10779855|NCT03744637|OG004|Outcome|MK-5475 300 ug: Part 2 Period 1 (Panel C)|Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
10779856|NCT03744637|OG005|Outcome|MK-5475 480 ug: Part 2 Period 1 (Panel D)|Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
10779857|NCT03744637|OG006|Outcome|Placebo: Part 1|Participants received placebo during Part 1.
10779858|NCT03744637|OG007|Outcome|MK-5475 120 ug: RHC (Panel C)|Participants in Panel C received MK-5475 120 ug during the RHC Period.
10779859|NCT03744637|OG008|Outcome|MK-5475 120 ug: RHC (Panel D)|Participants in Panel D received MK-5475 120 ug during the RHC Period.
10779860|NCT03744637|OG009|Outcome|MK-5475 165 ug: RHC (Panel B)|Participant in Panel B received MK-5475 165 ug during the RHC Period.
10779861|NCT03744637|OG010|Outcome|MK-5475 240 ug: RHC (Panel A)|Participants in Panel A received MK-5475 240 ug during the RHC Period.
10779862|NCT03744637|OG011|Outcome|MK-5475 360 ug: RHC (Panel B)|Participants in Panel B received MK-5475 360 ug during the RHC Period.
10779863|NCT03744637|OG012|Outcome|MK-5475 360 ug: RHC (Panel C)|Participants in Panel C received MK-5475 360 ug during the RHC Period.
10779864|NCT03744637|OG013|Outcome|MK-5475 120 ug: FRI (Panel C)|Participants in Panel C received MK-5475 120 ug during the FRI Period.
10779865|NCT03744637|OG014|Outcome|MK-5475 120 ug: FRI (Panel D)|Participants in Panel D received MK-5475 120 ug during the FRI Period.
10779866|NCT03744637|OG015|Outcome|MK-5475 165 ug: FRI (Panel B)|Participant in Panel B received MK-5475 165 ug during the FRI Period.
10779867|NCT03744637|OG016|Outcome|MK-5475 240 ug: FRI (Panel A)|Participants in Panel A received MK-5475 240 ug during the FRI Period.
10779868|NCT03744637|OG017|Outcome|MK-5475 360 ug: FRI (Panel B)|Participants in Panel B received MK-5475 360 ug during the FRI Period.
10779869|NCT03744637|OG018|Outcome|MK-5475 360 ug: FRI (Panel C)|Participants in Panel C received MK-5475 360 ug during the FRI Period.
10779870|NCT03744637|EG000|Reported Event|MK-5475 120 ug: Part 1 (Panel A)|Participants received MK-5475 120 ug during Part 1.
10779871|NCT03744637|EG001|Reported Event|MK-5475 165 ug: Part 1 (Panel A)|Participants received MK-5475 165 ug during Part 1.
10779872|NCT03744637|EG002|Reported Event|MK-5475 240 ug: Part 1 (Panel A)|Participants received MK-5475 240 ug during Part 1.
10779873|NCT03744637|EG003|Reported Event|MK-5475 300 ug: Part 2 Period 1 (Panels B+C)|Participants received MK-5475 300 ug during Part 2 Period 1.
10779874|NCT03744637|EG004|Reported Event|MK-5475 480 ug: Part 2 Period 1 (Panel D)|Participants received MK-5475 480 ug during Part 2 Period 1.
10779875|NCT03744637|EG005|Reported Event|Placebo: Part 1|Participants received placebo during Part 1.
10779876|NCT03744637|EG006|Reported Event|MK-5475 120 ug: RHC (Panel D)|Participants received MK-5475 120 ug during the RHC Period.
10779877|NCT03744637|EG007|Reported Event|MK-5475 165 ug: RHC (Panel B)|Participant received MK-5475 165 ug during the RHC Period.
10779878|NCT03744637|EG008|Reported Event|MK-5475 240 ug: RHC (Panel A)|Participants received MK-5475 240 ug during the RHC Period.
10779879|NCT03744637|EG009|Reported Event|MK-5475 360 ug: RHC (Panels B+C)|Participants received MK-5475 360 ug during the RHC Period.
10779880|NCT03744637|EG010|Reported Event|MK-5475 120 ug: FRI (Panels C+D)|Participants received MK-5475 120 ug during the FRI Period.
10779881|NCT03744637|EG011|Reported Event|MK-5475 165 ug: FRI (Panel B)|Participant received MK-5475 165 ug during the FRI Period.
10779882|NCT03744637|EG012|Reported Event|MK-5475 240 ug: FRI (Panel A)|Participants received MK-5475 240 ug during the FRI Period.
10779883|NCT03744637|EG013|Reported Event|MK-5475 360 ug: FRI (Panels B+C)|Participants received MK-5475 360 ug during the FRI Period.
10779884|NCT03576144|BG000|Baseline|Placebo Matching BI 1265162|Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.
10779885|NCT03576144|BG001|Baseline|10 Microgram (μg) BI 1265162|Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.
10779886|NCT03576144|BG002|Baseline|30 μg BI 1265162|Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.
10779887|NCT03576144|BG003|Baseline|100 μg BI 1265162|Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.
10779888|NCT03576144|BG004|Baseline|300 μg BI 1265162|Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.
10779889|NCT03576144|BG005|Baseline|600 μg BI 1265162|Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
10779890|NCT03576144|BG006|Baseline|Total|Total of all reporting groups
10779891|NCT03576144|FG000|Participant Flow|Placebo Matching BI 1265162|Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.
10964432|NCT00877448|FG003|Participant Flow|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
10779892|NCT03576144|FG001|Participant Flow|10 Microgram (μg) BI 1265162|Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.
10779893|NCT03576144|FG002|Participant Flow|30 μg BI 1265162|Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.
10779894|NCT03576144|FG003|Participant Flow|100 μg BI 1265162|Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.
10779895|NCT03576144|FG004|Participant Flow|300 μg BI 1265162|Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.
10779896|NCT03576144|FG005|Participant Flow|600 μg BI 1265162|Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
10779897|NCT03576144|OG000|Outcome|Placebo Matching BI 1265162|Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.
10779898|NCT03576144|OG001|Outcome|10 Microgram (μg) BI 1265162|Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.
10779899|NCT03576144|OG002|Outcome|30 μg BI 1265162|Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.
10779900|NCT03576144|OG003|Outcome|100 μg BI 1265162|Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.
10779901|NCT03576144|OG004|Outcome|300 μg BI 1265162|Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.
10779902|NCT03576144|OG005|Outcome|600 μg BI 1265162|Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
10779903|NCT03576144|OG000|Outcome|10 Microgram (μg) BI 1265162|Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.
10964433|NCT00877448|FG004|Participant Flow|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
10779904|NCT03576144|OG001|Outcome|30 μg BI 1265162|Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.
10779905|NCT03576144|OG002|Outcome|100 μg BI 1265162|Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.
10779906|NCT03576144|OG003|Outcome|300 μg BI 1265162|Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.
10779907|NCT03576144|OG004|Outcome|600 μg BI 1265162|Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
10779908|NCT03576144|EG000|Reported Event|Placebo Matching BI 1265162|Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.
10779909|NCT03576144|EG001|Reported Event|10 Microgram (μg) BI 1265162|Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.
10779910|NCT03576144|EG002|Reported Event|30 μg BI 1265162|Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.
10779911|NCT03576144|EG003|Reported Event|100 μg BI 1265162|Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.
10779912|NCT03576144|EG004|Reported Event|300 μg BI 1265162|Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.
11193471|NCT02145299|BG000|Baseline|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018 guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
10779913|NCT03576144|EG005|Reported Event|600 μg BI 1265162|Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
10779914|NCT03444038|BG000|Baseline|Valbenazine|Participants received valbenazine once daily for up to 24 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
10779915|NCT03444038|FG000|Participant Flow|Valbenazine|Participants received valbenazine once daily for up to 24 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
10779916|NCT03444038|OG000|Outcome|Valbenazine|Participants received valbenazine once daily for up to 24 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
10779917|NCT03444038|EG000|Reported Event|Valbenazine|Participants received valbenazine once daily for up to 24 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
10779918|NCT03432897|BG000|Baseline|Treatment|"Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.~Between 22-42 days post Olaparib, patients will undergo a prostatectomy.~Olaparib Pill: 300 mg BID~Prostatectomy: 22-42 days post Olaparib patients will undergo surgery"
10779919|NCT03432897|FG000|Participant Flow|Treatment|"Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.~Between 22-42 days post Olaparib, patients will undergo a prostatectomy.~Olaparib Pill: 300 mg BID~Prostatectomy: 22-42 days post Olaparib patients will undergo surgery"
10779920|NCT03432897|OG000|Outcome|Treatment|"Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.~Between 22-42 days post Olaparib, patients will undergo a prostatectomy.~Olaparib Pill: 300 mg BID~Prostatectomy: 22-42 days post Olaparib patients will undergo surgery"
10779921|NCT03432897|EG000|Reported Event|Treatment|"Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.~Between 22-42 days post Olaparib, patients will undergo a prostatectomy.~Olaparib Pill: 300 mg BID~Prostatectomy: 22-42 days post Olaparib patients will undergo surgery"
10779922|NCT03265665|BG000|Baseline|ACTION Intervention|"Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.~ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779923|NCT03265665|BG001|Baseline|Enhanced Usual Care|"Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.~Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.~Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779924|NCT03265665|BG002|Baseline|Total|Total of all reporting groups
10964434|NCT00877448|FG005|Participant Flow|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
10779925|NCT03265665|FG000|Participant Flow|ACTION Intervention|"Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.~ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779926|NCT03265665|FG001|Participant Flow|Enhanced Usual Care|"Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.~Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.~Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779927|NCT03265665|OG000|Outcome|Screen Participants|This is the number of participants that were screened for eligibility in the study.
10779928|NCT03265665|OG000|Outcome|ACTION Intervention|"Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.~ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779929|NCT03265665|OG001|Outcome|Enhanced Usual Care|"Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.~Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.~Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779930|NCT03265665|OG000|Outcome|ACTION Intervention|"Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.~ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10801126|NCT02279173|FG000|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
10801127|NCT02279173|OG000|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
10801128|NCT02279173|OG000|Outcome|Cohort 1|Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
10801129|NCT02279173|OG001|Outcome|Cohort 2|Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
10964435|NCT00877448|FG006|Participant Flow|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
10964436|NCT00877448|OG000|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
11193472|NCT02145299|BG001|Baseline|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (Crosser system) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
10779931|NCT03265665|EG000|Reported Event|ACTION Intervention|"Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.~ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779932|NCT03265665|EG001|Reported Event|Enhanced Usual Care|"Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.~Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.~Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
10779933|NCT03196180|BG000|Baseline|Treatment (Topical Fluorouracil, Imiquimod)|"Patients receive once-weekly intravaginal application of 5-fluorouracil and imiquimod used on alternating weeks for 8 to 16 weeks.~Imiquimod: Given intravaginally~Topical Fluorouracil: Given intravaginally"
10779934|NCT03196180|FG000|Participant Flow|Treatment (Topical Fluorouracil, Imiquimod)|"Patients receive once-weekly intravaginal application of 5-fluorouracil and imiquimod used on alternating weeks for 8 to 16 weeks.~Imiquimod: Given intravaginally~Topical Fluorouracil: Given intravaginally"
10779935|NCT03196180|OG000|Outcome|Treatment (Topical Fluorouracil, Imiquimod)|"Patients receive topical fluorouracil intravaginally via applicator at weeks 1, 3, 5, 7, 9, 11, 13, and 15 and imiquimod intravaginally via applicator at weeks 2, 4, 6, 8, 10, 12, 14, and 16. Patients who are menstruating will delay application until the end of the menstrual cycle.~Imiquimod: Given intravaginally~Topical Fluorouracil: Given intravaginally"
10779936|NCT03196180|EG000|Reported Event|Treatment (Topical Fluorouracil, Imiquimod)|"Patients receive once-weekly intravaginal application of 5-fluorouracil and imiquimod used on alternating weeks for 8 to 16 weeks.~Imiquimod: Given intravaginally~Topical Fluorouracil: Given intravaginally"
10779937|NCT02725593|BG000|Baseline|Dapagliflozin 10mg/ Dapagliflozin 10mg|Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
10779938|NCT02725593|BG001|Baseline|Placebo/ Dapagliflozin 10mg|Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
10779939|NCT02725593|BG002|Baseline|Total|Total of all reporting groups
10779940|NCT02725593|FG000|Participant Flow|Dapagliflozin 10mg/ Dapagliflozin 10mg|Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
10779941|NCT02725593|FG001|Participant Flow|Placebo/ Dapagliflozin 10mg|Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
10779942|NCT02725593|OG000|Outcome|Dapagliflozin 10mg/ Dapagliflozin 10mg|Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
11193473|NCT02145299|BG002|Baseline|Total|Total of all reporting groups
10779943|NCT02725593|OG001|Outcome|Placebo/ Dapagliflozin 10mg|Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
11193474|NCT02145299|FG000|Participant Flow|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018 guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
11193475|NCT02145299|FG001|Participant Flow|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (Crosser system) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
10779944|NCT02725593|EG000|Reported Event|Dapagliflozin 10mg/ Dapagliflozin 10mg|Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
10779945|NCT02725593|EG001|Reported Event|Placebo/ Dapagliflozin 10mg|Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
10779946|NCT02716675|BG000|Baseline|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779947|NCT02716675|BG001|Baseline|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779948|NCT02716675|BG002|Baseline|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779949|NCT02716675|BG003|Baseline|Total|Total of all reporting groups
10779950|NCT02716675|FG000|Participant Flow|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779951|NCT02716675|FG001|Participant Flow|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779952|NCT02716675|FG002|Participant Flow|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779953|NCT02716675|OG000|Outcome|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779954|NCT02716675|OG001|Outcome|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779955|NCT02716675|OG002|Outcome|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779956|NCT02716675|OG003|Outcome|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779957|NCT02716675|OG000|Outcome|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779958|NCT02716675|OG001|Outcome|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779959|NCT02716675|OG000|Outcome|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779960|NCT02716675|EG000|Reported Event|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779961|NCT02716675|EG001|Reported Event|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779962|NCT02716675|EG002|Reported Event|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779963|NCT02716675|EG003|Reported Event|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10779964|NCT02636946|BG000|Baseline|SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)|"Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later."
10779965|NCT02636946|BG001|Baseline|Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)|"Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later."
10779966|NCT02636946|BG002|Baseline|Total|Total of all reporting groups
10779967|NCT02636946|FG000|Participant Flow|SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)|"Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later."
10801130|NCT02279173|EG000|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
10850585|NCT00303472|OG001|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
10964437|NCT00877448|OG001|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
10779968|NCT02636946|FG001|Participant Flow|Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)|"Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later."
10779969|NCT02636946|OG000|Outcome|Selective Laser Trabeculoplasty|"SLT administered on Day 1.~Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses."
10779970|NCT02636946|OG001|Outcome|Bim SR 15 μg|"Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses."
10779971|NCT02636946|EG000|Reported Event|SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)|"Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later."
10779972|NCT02636946|EG001|Reported Event|Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)|"Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.~Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later."
10779973|NCT02631941|BG000|Baseline|A-B1-B2-C-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779974|NCT02631941|BG001|Baseline|B1-C-A-D-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10801131|NCT02258451|BG000|Baseline|Radium-223 + EXE/EVE|Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10801132|NCT02258451|BG001|Baseline|Placebo + EXE/EVE|Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10801133|NCT02258451|BG002|Baseline|Total|Total of all reporting groups
10850586|NCT00303472|OG002|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
10779975|NCT02631941|BG002|Baseline|C-D-B1-B2-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779976|NCT02631941|BG003|Baseline|D-B2-C-A-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779977|NCT02631941|BG004|Baseline|B2-A-D-B1-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779978|NCT02631941|BG005|Baseline|D-C-B2-B1-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779979|NCT02631941|BG006|Baseline|B2-D-A-C-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779980|NCT02631941|BG007|Baseline|A-B2-B1-D-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779981|NCT02631941|BG008|Baseline|B1-A-C-B2-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779982|NCT02631941|BG009|Baseline|C-B1-D-A-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779983|NCT02631941|BG010|Baseline|Total|Total of all reporting groups
10779984|NCT02631941|FG000|Participant Flow|A-B1-B2-C-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779985|NCT02631941|FG001|Participant Flow|B1-C-A-D-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10964438|NCT00877448|OG002|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
10779986|NCT02631941|FG002|Participant Flow|C-D-B1-B2-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779987|NCT02631941|FG003|Participant Flow|D-B2-C-A-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779988|NCT02631941|FG004|Participant Flow|B2-A-D-B1-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779989|NCT02631941|FG005|Participant Flow|D-C-B2-B1-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
11193476|NCT02145299|OG000|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018 guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
11193477|NCT02145299|OG001|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (Crosser system) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
10779990|NCT02631941|FG006|Participant Flow|B2-D-A-C-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779991|NCT02631941|FG007|Participant Flow|A-B2-B1-D-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779992|NCT02631941|FG008|Participant Flow|B1-A-C-B2-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779993|NCT02631941|FG009|Participant Flow|C-B1-D-A-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10779994|NCT02631941|OG000|Outcome|Treatment A|Z7200 without charcoal (160 ug budesonide)
10779995|NCT02631941|OG001|Outcome|Treatment B|Symbicort 1+2 without charcoal (320 ug budesonide)
10779996|NCT02631941|OG002|Outcome|Treatment C|Z7200 with charcoal (160 ug budesonide)
10779997|NCT02631941|OG003|Outcome|Treatment D|Symbicort with charcoal (320 ug budesonide)
10779998|NCT02631941|EG000|Reported Event|Treatment A|Z7200 without charcoal (160 ug budesonide)
10779999|NCT02631941|EG001|Reported Event|Treatment B|Symbicort 1+2 without charcoal (320 ug budesonide)
10780000|NCT02631941|EG002|Reported Event|Treatment C|Z7200 with charcoal (160 ug budesonide)
10780001|NCT02631941|EG003|Reported Event|Treatment D|Symbicort with charcoal (320 ug budesonide)
10780002|NCT02568215|BG000|Baseline|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780003|NCT02568215|BG001|Baseline|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780004|NCT02568215|BG002|Baseline|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780005|NCT02568215|BG003|Baseline|Total|Total of all reporting groups
10780006|NCT02568215|FG000|Participant Flow|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
11379124|NCT03782792|BG001|Baseline|Spesolimab 900 mg i.v SD|"Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks.~If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8.~If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12."
11379125|NCT03782792|BG002|Baseline|Total|Total of all reporting groups
11379126|NCT03782792|FG000|Participant Flow|Placebo|Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
11379127|NCT03782792|FG001|Participant Flow|Spesolimab 900 mg i.v SD|"Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks.~If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8.~If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12."
11379128|NCT03782792|OG000|Outcome|Placebo|Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
11379129|NCT03782792|OG001|Outcome|Spesolimab 900 mg i.v SD|"Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks.~If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8.~If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12."
11379130|NCT03782792|EG000|Reported Event|Placebo|Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
10780007|NCT02568215|FG001|Participant Flow|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780008|NCT02568215|FG002|Participant Flow|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780009|NCT02568215|OG000|Outcome|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780010|NCT02568215|OG001|Outcome|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780011|NCT02568215|OG002|Outcome|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780012|NCT02568215|OG003|Outcome|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780013|NCT02568215|OG000|Outcome|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780014|NCT02568215|OG001|Outcome|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780015|NCT02568215|OG000|Outcome|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780016|NCT02568215|EG000|Reported Event|Placebo|Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780017|NCT02568215|EG001|Reported Event|Low-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780018|NCT02568215|EG002|Reported Event|High-Dose VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780019|NCT02568215|EG003|Reported Event|Pooled VRC01|VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
10780020|NCT02562378|BG000|Baseline|Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
10780021|NCT02562378|BG001|Baseline|Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
10780022|NCT02562378|BG002|Baseline|Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
10780023|NCT02562378|BG003|Baseline|Total|Total of all reporting groups
10780024|NCT02562378|FG000|Participant Flow|Period 1: Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)|Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 45 mg/m2.
10780025|NCT02562378|FG001|Participant Flow|Period 2: Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)|Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 50 mg/m2.
10780026|NCT02562378|FG002|Participant Flow|Period 3: Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)|Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 60 mg/m2.
10780027|NCT02562378|OG000|Outcome|Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
10780028|NCT02562378|OG001|Outcome|Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
10780029|NCT02562378|OG002|Outcome|Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
10780030|NCT02562378|EG000|Reported Event|Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
10780031|NCT02562378|EG001|Reported Event|Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
10780032|NCT02562378|EG002|Reported Event|Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)|Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
10780033|NCT02528643|BG000|Baseline|Placebo|Participants received enzalutamide matching placebo orally, QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780034|NCT02528643|BG001|Baseline|Enzalutamide|Participants received enzalutamide 160 mg capsules, orally QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780035|NCT02528643|BG002|Baseline|Total|Total of all reporting groups
10780036|NCT02528643|FG000|Participant Flow|Placebo|Participants received enzalutamide matching placebo orally, once daily (QD) during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10850587|NCT00303472|EG000|Reported Event|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10780037|NCT02528643|FG001|Participant Flow|Enzalutamide|Participants received enzalutamide 160 milligrams (mg) capsules, orally QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Eligible participants received enzalutamide 160 mg capsules, orally QD during open label period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780038|NCT02528643|OG000|Outcome|Placebo|Participants received enzalutamide matching placebo orally, QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780039|NCT02528643|OG001|Outcome|Enzalutamide|Participants received enzalutamide 160 mg capsules, orally QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780040|NCT02528643|OG001|Outcome|Enzalutamide|Participants received enzalutamide 160 milligrams (mg) capsules, orally, QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Eligible participants received enzalutamide 160 mg capsules, orally QD during open label period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780041|NCT02528643|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg capsules, orally QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780042|NCT02528643|EG000|Reported Event|Placebo|Participants received enzalutamide matching placebo orally, QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780043|NCT02528643|EG001|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg capsules, orally, QD during double blind treatment period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Eligible participants received enzalutamide 160 mg capsules, orally QD during open label period until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. Median treatment duration was 64 days.
10780044|NCT02416011|BG000|Baseline|Assessment Only (ASSESS)|Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
10780045|NCT02416011|BG001|Baseline|Generic Self-Help (GENERIC)|"This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.~GENERIC: The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study."
10780046|NCT02416011|BG002|Baseline|Targeted Self-Help (eTARGET)|"Participants in this condition will receive the intervention created as the product of Study I.~eTARGET: The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets."
10780047|NCT02416011|BG003|Baseline|Total|Total of all reporting groups
11193478|NCT02145299|EG000|Reported Event|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018 guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
11193479|NCT02145299|EG001|Reported Event|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (Crosser system) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
10780048|NCT02416011|FG000|Participant Flow|Assessment Only (ASSESS)|Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
10780049|NCT02416011|FG001|Participant Flow|Generic Self-Help (GENERIC)|"This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.~GENERIC: The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study."
10780050|NCT02416011|FG002|Participant Flow|Targeted Self-Help (eTARGET)|"Participants in this condition will receive the intervention created as the product of Study I.~eTARGET: The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets."
10780051|NCT02416011|OG000|Outcome|ASSESS at 18 Months|Participants in this condition did not receive any intervention materials.
10780052|NCT02416011|OG001|Outcome|ASSESS at 24 Months|Participants in this condition did not receive any intervention materials.
10780053|NCT02416011|OG002|Outcome|GENERIC at 18 Months|This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
10780054|NCT02416011|OG003|Outcome|GENERIC at 24 Months|This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
10780055|NCT02416011|OG004|Outcome|eTARGET at 18 Months|Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
10780056|NCT02416011|OG005|Outcome|eTARGET at 24 Months|Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
10780057|NCT02416011|OG000|Outcome|Asses Cigarette Use at 18 Months|Participants in this condition did not receive any intervention
10780058|NCT02416011|OG001|Outcome|ASSESS Cigarette Use at 24 Months|Participants in this condition did not receive any intervention materials.
10780059|NCT02416011|OG002|Outcome|ASSES Vaping at 18 Months|Participants in this condition did not receive any intervention
10780060|NCT02416011|OG003|Outcome|ASSESS Vaping at 24 Months|Participants in this condition did not receive any intervention materials.
10780061|NCT02416011|OG000|Outcome|ASSESS Group at 18 Months|Participants in this condition did not receive any intervention materials
10780062|NCT02416011|OG001|Outcome|ASSESS Group at 24 Months|Participants in this condition did not receive any intervention
10780063|NCT02416011|OG002|Outcome|GENERIC Group at 18 Months|This group allowed investigators to evaluate their novel self-help intervention for e-cigarette users (If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
10780064|NCT02416011|OG003|Outcome|GENERIC Group at 24 Months|This group allowed investigators to evaluate their novel self-help intervention for e-cigarette users (If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
10780065|NCT02416011|OG004|Outcome|eTARGET Group at 18 Months|Participants in this condition received the intervention; If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
10780066|NCT02416011|OG005|Outcome|eTarget Group at 24 Months|Participants in this condition received the intervention; If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
10780067|NCT02416011|EG000|Reported Event|Assessment Only (ASSESS)|Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
10780068|NCT02416011|EG001|Reported Event|Generic Self-Help (GENERIC)|"This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.~GENERIC: The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study."
10780069|NCT02416011|EG002|Reported Event|Targeted Self-Help (eTARGET)|"Participants in this condition will receive the intervention created as the product of Study I.~eTARGET: The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets."
10801134|NCT02258451|FG000|Participant Flow|Radium-223 + EXE/EVE|Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10801135|NCT02258451|FG001|Participant Flow|Placebo + EXE/EVE|Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10801136|NCT02258451|OG000|Outcome|Radium-223 + EXE/EVE|Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10780070|NCT02237508|BG000|Baseline|A-B1-B2-C-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780071|NCT02237508|BG001|Baseline|B1-C-A-D-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780072|NCT02237508|BG002|Baseline|C-D-B1-B2-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780073|NCT02237508|BG003|Baseline|D-B2-C-A-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780074|NCT02237508|BG004|Baseline|B2-A-D-B1-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10964439|NCT00877448|OG003|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
11379131|NCT03782792|EG001|Reported Event|Spesolimab 900 mg i.v. SD|"Patients received intravenously (i.v.) a single dose of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks.~If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8.~If the condition of the patient worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12."
11379132|NCT03782792|EG002|Reported Event|Open Label (OL) D8 Spesolimab 900 mg i.v.|This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v. spesolimab at Day 1) received also Open Label Treatment with 900 mg I.V spesolimab at Week 1 (Wk1)/Day 8 (D8).
11379133|NCT03782792|EG003|Reported Event|Rescue Spesolimab 900 mg i.v.|This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v spesolimab at Day 1) also one single rescue i.v. dose of 900 mg spesolimab between Week 1(Wk 1) to Week 12 (Wk 12).
11379134|NCT03750461|BG000|Baseline|Intervention|"Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall~Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation"
11379135|NCT03750461|BG001|Baseline|Historical Controls|Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.
11379136|NCT03750461|BG002|Baseline|Total|Total of all reporting groups
11379137|NCT03750461|FG000|Participant Flow|Intervention|"Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall~Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation"
11379138|NCT03750461|FG001|Participant Flow|Historical Controls|Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.
11379139|NCT03750461|OG000|Outcome|Intervention|"Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall~Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation"
11379140|NCT03750461|OG001|Outcome|Historical Controls|Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.
11379141|NCT03750461|EG000|Reported Event|Intervention|"Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall~Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation"
11379142|NCT03750461|EG001|Reported Event|Historical Controls|Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.
11379143|NCT03733119|BG000|Baseline|Akt/ERK Inhibitor ONC201|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379144|NCT03733119|BG001|Baseline|Akt/ERK Inhibitor ONC201, Methionine-restricted Diet|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379145|NCT03733119|BG002|Baseline|Total|Total of all reporting groups
11379146|NCT03733119|FG000|Participant Flow|Akt/ERK Inhibitor ONC201|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379147|NCT03733119|FG001|Participant Flow|Akt/ERK Inhibitor ONC201, Methionine-restricted Diet|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379148|NCT03733119|OG000|Outcome|Akt/ERK Inhibitor ONC201|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379149|NCT03733119|OG001|Outcome|Akt/ERK Inhibitor ONC201, Methionine-restricted Diet|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379150|NCT03733119|EG000|Reported Event|Akt/ERK Inhibitor ONC201|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11379151|NCT03733119|EG001|Reported Event|Akt/ERK Inhibitor ONC201, Methionine-restricted Diet|Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10801137|NCT02258451|OG001|Outcome|Placebo + EXE/EVE|Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10780075|NCT02237508|BG005|Baseline|D-C-B2-B1-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780076|NCT02237508|BG006|Baseline|B2-D-A-C-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780077|NCT02237508|BG007|Baseline|A-B2-B1-D-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780078|NCT02237508|BG008|Baseline|B1-A-C-B2-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780079|NCT02237508|BG009|Baseline|C-B1-D-A-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
11193480|NCT02145429|BG000|Baseline|Problem Solving Therapy + Behavioral Treatment of Insomnia|"Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed~Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.~Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services."
11193481|NCT02145429|BG001|Baseline|Enhanced Usual Care|Care as usual with scheduled assessments of clinical status
11379152|NCT03661996|BG000|Baseline|Group 1. Breg Cooling Control|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.
11379153|NCT03661996|BG001|Baseline|Group 2. Gel Pack Cooling|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.
11379154|NCT03661996|BG002|Baseline|Group 3. Shortened Gel Pack Cooling|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.
11379155|NCT03661996|BG003|Baseline|Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine|The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
11379156|NCT03661996|BG004|Baseline|Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine|The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
11379157|NCT03661996|BG005|Baseline|Total|Total of all reporting groups
11379158|NCT03661996|FG000|Participant Flow|Group 1. Breg Cooling Control|Breg Cooler (total cool time at least 85 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975
10780080|NCT02237508|BG010|Baseline|Total|Total of all reporting groups
11193482|NCT02145429|BG002|Baseline|Total|Total of all reporting groups
11379159|NCT03661996|FG001|Participant Flow|Group 2. Gel Pack Cooling|Gel Pack Cooling (total cool time at least 60 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975
11379160|NCT03661996|FG002|Participant Flow|Group 3. Shortened Gel Pack Cooling|Gel pack cooling (total cool time at least 35 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975
11379161|NCT03661996|FG003|Participant Flow|Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine|Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 2% lidocaine followed by CNTX-4975
11379162|NCT03661996|FG004|Participant Flow|Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine|Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 1% lidocaine followed by CNTX-4975
11379163|NCT03661996|OG000|Outcome|Group 1. Breg Cooling Control|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.
11379164|NCT03661996|OG001|Outcome|Group 2. Gel Pack Cooling|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.
11379165|NCT03661996|OG002|Outcome|Group 3. Shortened Gel Pack Cooling|The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.
11379166|NCT03661996|OG003|Outcome|Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine|The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
10780081|NCT02237508|FG000|Participant Flow|A-B1-B2-C-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780082|NCT02237508|FG001|Participant Flow|B1-C-A-D-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780083|NCT02237508|FG002|Participant Flow|C-D-B1-B2-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780084|NCT02237508|FG003|Participant Flow|D-B2-C-A-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780085|NCT02237508|FG004|Participant Flow|B2-A-D-B1-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10801138|NCT02258451|OG000|Outcome|Radium-223 + EXE/EVE|Participants who received treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10780086|NCT02237508|FG005|Participant Flow|D-C-B2-B1-A|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780087|NCT02237508|FG006|Participant Flow|B2-D-A-C-B1|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780088|NCT02237508|FG007|Participant Flow|A-B2-B1-D-C|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780089|NCT02237508|FG008|Participant Flow|B1-A-C-B2-D|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780090|NCT02237508|FG009|Participant Flow|C-B1-D-A-B2|"Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design:~Treatment A: Z7200 without oral activated charcoal~Treatment B1: Symbicort 1 without oral activated charcoal~Treatment B1: Symbicort 2 without oral activated charcoal~Treatment C: Z7200 with oral activated charcoal~Treatment D: Symbicort with oral activated charcoal~A washout period ≥5 days followed treatment periods 1 to 4.~Z7200 without activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).~Symbicort Turbohaler without activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).~Z7200 with activated charcoal: 160 ug budesonide and 4.5 ug formoterol, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).~Symbicort Turbohaler with activated charcoal: 320 ug budesonide and 9 ug formoterol, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation, with charcoal blockade (Treatment D)."
10780091|NCT02237508|OG000|Outcome|Treatment A|Z7200 without charcoal (160 ug budesonide)
10780092|NCT02237508|OG001|Outcome|Treatment B|Symbicort 1+2 without charcoal (320 ug budesonide)
10780093|NCT02237508|OG002|Outcome|Treatment C|Z7200 with charcoal (160 ug budesonide)
10780094|NCT02237508|OG003|Outcome|Treatment D|Symbicort with charcoal (320 ug budesonide)
11193483|NCT02145429|FG000|Participant Flow|Problem Solving Therapy + Behavioral Treatment of Insomnia|"Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed~Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.~Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services."
11193484|NCT02145429|FG001|Participant Flow|Enhanced Usual Care|Care as usual with scheduled assessments of clinical status
11193485|NCT02145429|OG000|Outcome|Problem Solving Therapy + Behavioral Treatment of Insomnia|"Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed~Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.~Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services."
11379167|NCT03661996|OG004|Outcome|Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine|The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
11379168|NCT03661996|OG000|Outcome|Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE|Subjects with moderate to severe OA knee pain in the index knee and mild to no pain in the non-index knee; results reported for the index knee
11379169|NCT03661996|OG001|Outcome|Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE|Subjects with single knee OA pain in the index knee and a partial or total knee joint replacement in the non-index knee; results reported for index knee
11379170|NCT03661996|OG002|Outcome|Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE|Subjects with moderate to severe knee OA pain in both the index and non-index knee; results reported for the index knee in these subjects
11379171|NCT03661996|OG003|Outcome|Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE|Subjects with moderate to severe knee OA pain in both the index and non-index knee that received bilateral injections of CNTX-4975; results reported for the non-index knee in these subjects
11379172|NCT03661996|EG000|Reported Event|Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) Day 1 Through Week 8/Early Termination|Subjects with moderate to severe OA knee pain in the index knee and mild to no pain in the non-index knee; TEAEs presented for subjects in the Single Knee Injection groups represents TEAEs occurring from Day 1 through Week 8/Early Termination
10780095|NCT02237508|OG000|Outcome|Treatment A|Z7200 without charcoal (4.5 ug formoterol)
10964440|NCT00877448|OG004|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
11193486|NCT02145429|OG001|Outcome|Enhanced Usual Care|Care as usual with scheduled assessments of clinical status
11379173|NCT03661996|EG001|Reported Event|Single Knee Injection (Non-Index Knee PJR/TJR) Day 1 Through Week 8/Early Termination|"Single Knee Injection (Non-index Knee partial or total joint replacement)~Data presented for subjects in the Single Knee Injection groups represents TEAEs occurring from Day 1 through Week 8/Early Termination"
11379174|NCT03661996|EG002|Reported Event|Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 1 Through Day 7|Subjects with moderate to severe knee OA pain in both the index and non-index knee; TEAEs presented for subjects in the Bilateral Knee Injection group only from Day 1 (index knee) through Day 7 (i.e., prior to them receiving the second intra-articular injection of CNTX-4975)
11379175|NCT03661996|EG003|Reported Event|Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 7 Through Week 8/Early Termination|Subjects with moderate to severe knee OA pain in both the index and non-index knee that received bilateral injections of CNTX-4975; TEAEs presented for subjects in the Bilateral Knee Injection group from Day 8 (i.e., after receiving the second injection of CNTX-4975 into the nonindex knee) to Week 8/Early Termination. Note: 96 subjects did not receive a second injection of CNTX-4975
11379176|NCT03633461|BG000|Baseline|OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml|"OC-02 (simpinicline) nasal spray, 11.1 mg/ml~OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml"
11379177|NCT03633461|BG001|Baseline|Placebo|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11379178|NCT03633461|BG002|Baseline|Total|Total of all reporting groups
11379179|NCT03633461|FG000|Participant Flow|OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml|"OC-02 (simpinicline) nasal spray, 11.1 mg/ml~OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml"
11379180|NCT03633461|FG001|Participant Flow|Placebo|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11379181|NCT03633461|OG000|Outcome|OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml|"OC-02 (simpinicline) nasal spray, 11.1 mg/ml~OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml"
11379182|NCT03633461|OG001|Outcome|Placebo|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11379183|NCT03633461|EG000|Reported Event|OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml|"OC-02 (simpinicline) nasal spray, 11.1 mg/ml~OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml"
11379184|NCT03633461|EG001|Reported Event|Placebo|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11379185|NCT03622658|BG000|Baseline|Placebo|"Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks~Placebo: Placebo solution for subcutaneous injection."
11379186|NCT03622658|BG001|Baseline|Namilumab|"Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks~Namilumab: Namilumab solution for subcutaneous injection"
11379187|NCT03622658|BG002|Baseline|Total|Total of all reporting groups
11379188|NCT03622658|FG000|Participant Flow|Placebo|"Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks~Placebo: Placebo solution for subcutaneous injection."
11379189|NCT03622658|FG001|Participant Flow|Namilumab|"Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks~Namilumab: Namilumab solution for subcutaneous injection"
11379190|NCT03622658|OG000|Outcome|Placebo|"Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks~Placebo: Placebo solution for subcutaneous injection."
11379191|NCT03622658|OG001|Outcome|Namilumab|"Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks~Namilumab: Namilumab solution for subcutaneous injection"
11379192|NCT03622658|EG000|Reported Event|Placebo|"Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks~Placebo: Placebo solution for subcutaneous injection."
10780096|NCT02237508|OG001|Outcome|Treatment B|Symbicort 1+2 without charcoal (9 ug formoterol)
11379193|NCT03622658|EG001|Reported Event|Namilumab|"Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks~Namilumab: Namilumab solution for subcutaneous injection"
10780097|NCT02237508|OG002|Outcome|Treatment C|Z7200 with charcoal (4.5 ug formoterol)
10780098|NCT02237508|OG003|Outcome|Treatment D|Symbicort with charcoal (9 ug formoterol)
10780099|NCT02237508|OG000|Outcome|Treatment A|Z7200 without charcoal
10780100|NCT02237508|OG001|Outcome|Treatment B|Symbicort 1+2 without charcoal
10780101|NCT02237508|OG002|Outcome|Treatment C|Z7200 with charcoal
10780102|NCT02237508|OG003|Outcome|Treatment D|Symbicort with charcoal
10780103|NCT02237508|EG000|Reported Event|Treatment A|Z7200 without charcoal
10780104|NCT02237508|EG001|Reported Event|Treatment B|Symbicort 1+2 without charcoal
10780105|NCT02237508|EG002|Reported Event|Treatment C|Z7200 with charcoal
10780106|NCT02237508|EG003|Reported Event|Treatment D|Symbicort with charcoal
10964441|NCT00877448|OG005|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
10964442|NCT00877448|OG006|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
10964443|NCT00877448|EG000|Reported Event|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
10964444|NCT00877448|EG001|Reported Event|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
10964445|NCT00877448|EG002|Reported Event|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
10964446|NCT00877448|EG003|Reported Event|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
10964447|NCT00877448|EG004|Reported Event|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
10964448|NCT00877448|EG005|Reported Event|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
10964449|NCT00877448|EG006|Reported Event|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
10964450|NCT00877487|BG000|Baseline|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
10964451|NCT00877487|FG000|Participant Flow|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
10964452|NCT00877487|FG001|Participant Flow|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
10964453|NCT00877487|OG000|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
10964454|NCT00877487|OG001|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
10964455|NCT00877487|EG000|Reported Event|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
10964456|NCT00877487|EG001|Reported Event|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
10964457|NCT00877604|BG000|Baseline|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
10964458|NCT00877604|BG001|Baseline|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule"
10801139|NCT02258451|OG001|Outcome|Placebo + EXE/EVE|Participants did not receive any radium-223 dichloride, but received treatment with any study treatment (placebo, exemestane [25-mg tablet once daily (after a meal)], and everolimus [10 mg once daily (with or without food)]), and supportive care as per the local or institutional standard of practice
10801140|NCT02258451|EG000|Reported Event|Radium-223 + EXE/EVE|Participants who received treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
10801141|NCT02258451|EG001|Reported Event|Placebo + EXE/EVE|Participants did not receive any radium-223 dichloride, but received treatment with any study treatment (placebo, exemestane [25-mg tablet once daily (after a meal)], and everolimus [10 mg once daily (with or without food)]), and supportive care as per the local or institutional standard of practice
10801142|NCT02186834|BG000|Baseline|Selinexor, Liposomal Doxorubicin and Dexamethasone|Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
10801143|NCT02186834|FG000|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1|Dose 1: Participants were administered Lipodox 20 mg/m^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801144|NCT02186834|FG001|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2|Dose 2: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801145|NCT02186834|FG002|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m|Dose 1m: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801146|NCT02186834|FG003|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m|Dose 2m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801147|NCT02186834|FG004|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m|Dose 3m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801148|NCT02186834|FG005|Participant Flow|Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D|Phase 2 Dose: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801149|NCT02186834|OG000|Outcome|Selinexor, Liposomal Doxorubicin and Dexamethasone|Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
10964459|NCT00877604|BG002|Baseline|Total|Total of all reporting groups
11379194|NCT03600142|BG000|Baseline|Standard of Care (SoC)|Participants randomized to the control condition will receive the standard HIV counseling protocol in the clinic, which is administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tests positive for HIV, counseling should help the woman/couple to accept an HIV test result and discuss implications for treatment.
11379195|NCT03600142|BG001|Baseline|SoC + Stigma Counseling (Maisha)|"Participants randomized to the intervention condition will receive the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tests positive for HIV, two counseling sessions. If a male partner is present with the women, he may also be enrolled and participate in the first two counseling sessions together with the woman.~Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement."
11379196|NCT03600142|BG002|Baseline|Total|Total of all reporting groups
11379197|NCT03600142|FG000|Participant Flow|Standard of Care (SoC)|Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment.
11379198|NCT03600142|FG001|Participant Flow|SoC + Stigma Counseling (Maisha)|"Participants randomized to the intervention condition (n=758) received the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated in the first two counseling sessions together with the woman.~Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention was developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement."
11379199|NCT03600142|OG000|Outcome|Standard of Care (SoC)|Participants randomized to the control condition will receive the standard HIV counseling protocol in the clinic, which is administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tests positive for HIV, counseling should help the woman/couple to accept an HIV test result and discuss implications for treatment.
11379200|NCT03600142|OG001|Outcome|SoC + Stigma Counseling (Maisha)|"Participants randomized to the intervention condition will receive the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tests positive for HIV, two counseling sessions. If a male partner is present with the women, he may also be enrolled and participate in the first two counseling sessions together with the woman.~Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement."
11379201|NCT03600142|OG000|Outcome|Standard of Care (SoC)|Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment.
11379202|NCT03600142|OG001|Outcome|SoC + Stigma Counseling (Maisha)|"Participants randomized to the intervention condition (n=758) received the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated in the first two counseling sessions together with the woman.~Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention was developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement."
11379203|NCT03600142|EG000|Reported Event|Standard of Care (SoC)|Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment.
10964460|NCT00877604|FG000|Participant Flow|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
10964461|NCT00877604|FG001|Participant Flow|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
10964462|NCT00877604|OG000|Outcome|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
10964463|NCT00877604|OG001|Outcome|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
10964464|NCT00877604|EG000|Reported Event|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
10964465|NCT00877604|EG001|Reported Event|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
10964466|NCT00877773|BG000|Baseline|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
10780132|NCT01706705|BG000|Baseline|Experimental Brachytherapy Treatment Planning|Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
11193487|NCT02145429|EG000|Reported Event|Problem Solving Therapy + Behavioral Treatment of Insomnia|"Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed~Problem Solving therapy and Brief Behavioral Treatment of Insomnia: Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.~Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services."
10780133|NCT01706705|FG000|Participant Flow|Experimental Brachytherapy Treatment Planning|Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
10780134|NCT01706705|OG000|Outcome|Experimental Brachytherapy Treatment Planning|Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
10780135|NCT01706705|OG000|Outcome|Single Arm-Study|Experimental Brachytherapy Treatment Planning
10780136|NCT01706705|EG000|Reported Event|Experimental Brachytherapy Treatment Planning|Single Arm study in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
10780137|NCT01609842|BG000|Baseline|Intervention|Patients at intervention sites who received the intervention during the period of enrollment
10780138|NCT01609842|BG001|Baseline|Pre-Intervention Control|Patients at intervention sites prior to the period of enrollment who did not received the intervention
10780139|NCT01609842|BG002|Baseline|Post-Intervention Control|Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
10780140|NCT01609842|BG003|Baseline|Concurrent Intervention Control|Patients at nonintervention sites during the period of enrollment at the intervention sites
10780141|NCT01609842|BG004|Baseline|Total|Total of all reporting groups
10780142|NCT01609842|FG000|Participant Flow|Intervention|Patients at intervention sites who received the intervention during the period of enrollment
10780143|NCT01609842|FG001|Participant Flow|Control|Patients who did not received the intervention
10780144|NCT01609842|OG000|Outcome|Intervention|Patients at intervention sites who received the intervention during the period of enrollment
10780145|NCT01609842|OG001|Outcome|Pre-intervention Control|Patients at intervention sites prior to the period of enrollment who did not received the intervention
11193488|NCT02145429|EG001|Reported Event|Enhanced Usual Care|Care as usual with scheduled assessments of clinical status
10780146|NCT01609842|OG002|Outcome|Post-intervention Control|Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
10780147|NCT01609842|OG003|Outcome|Concurrent Intervention Control|Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
10780148|NCT01609842|OG001|Outcome|Pre-Intervention Control|Patients at intervention sites prior to the period of enrollment who did not received the intervention
10780149|NCT01609842|OG002|Outcome|Post-Intervention Control|Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
10780150|NCT01609842|EG000|Reported Event|Intervention Arm|"An alerted inpatient pharmacist or a designated study team member will bring the clopidogrel medication to the patient who has received a coronary stent. The patient will return home and receive IVR refill reminder calls.~Multifaceted Intervention with pharmacist and IVR: An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call."
10780151|NCT01609842|EG001|Reported Event|Usual Care|"The sites will have no interaction with the study personnel. The investigators will use database information to compare with the intervention sites~Multifaceted Intervention with pharmacist and IVR: An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call."
10801150|NCT02186834|EG000|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1|Dose 1: Participants were administered Lipodox 20 mg/m^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10964467|NCT00877773|FG000|Participant Flow|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
10964468|NCT00877773|OG000|Outcome|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
10964469|NCT00877773|EG000|Reported Event|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
10780152|NCT01341600|BG000|Baseline|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780153|NCT01341600|BG001|Baseline|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780154|NCT01341600|BG002|Baseline|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780155|NCT01341600|BG003|Baseline|Total|Total of all reporting groups
10780156|NCT01341600|FG000|Participant Flow|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780157|NCT01341600|FG001|Participant Flow|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780158|NCT01341600|FG002|Participant Flow|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780159|NCT01341600|OG000|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780160|NCT01341600|OG001|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780161|NCT01341600|OG002|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780162|NCT01341600|EG000|Reported Event|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10964470|NCT00877799|BG000|Baseline|Cohort 1: Placebo|Matched placebo administered 24 hours post-surgery (Day 1)
10780163|NCT01341600|EG001|Reported Event|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780164|NCT01341600|EG002|Reported Event|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).~Clopidogrel, Omeprazole: Over a 6 week period participants will be given:~75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
10780165|NCT01044901|BG000|Baseline|Subjects With Sickle Cell Disease (SCD)|"38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780166|NCT01044901|BG001|Baseline|Healthy Volunteers|"13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780167|NCT01044901|BG002|Baseline|Total|Total of all reporting groups
10780168|NCT01044901|FG000|Participant Flow|Subjects With Sickle Cell Disease (SCD)|"38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780169|NCT01044901|FG001|Participant Flow|Healthy Volunteers|"13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780170|NCT01044901|OG000|Outcome|Subjects With Sickle Cell Disease (SCD)|"38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780171|NCT01044901|OG001|Outcome|Healthy Volunteers|"13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780172|NCT01044901|EG000|Reported Event|Subjects With Sickle Cell Disease (SCD)|"38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10780173|NCT01044901|EG001|Reported Event|Healthy Volunteers|"13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.~MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures."
10964471|NCT00877799|BG001|Baseline|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
10964472|NCT00877799|BG002|Baseline|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
10964473|NCT00877799|BG003|Baseline|Cohort 2: Placebo|Matched placebo administered within 3 hours post-surgery (Day 0)
10964474|NCT00877799|BG004|Baseline|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)
10964475|NCT00877799|BG005|Baseline|Total|Total of all reporting groups
10964476|NCT00877799|FG000|Participant Flow|Cohort 1: Placebo|Matched Placebo administered 24 hours post-surgery (Day 1)
10964477|NCT00877799|FG001|Participant Flow|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
10964478|NCT00877799|FG002|Participant Flow|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
10964479|NCT00877799|FG003|Participant Flow|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
10964480|NCT00877799|FG004|Participant Flow|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
10964481|NCT00877799|OG000|Outcome|Cohort 2: Placebo|Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
10964482|NCT00877799|OG001|Outcome|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
10964483|NCT00877799|OG000|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
10964484|NCT00877799|OG001|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
10780192|NCT00003479|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10780193|NCT00003479|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10780194|NCT00003479|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10780195|NCT00003479|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10801151|NCT02186834|EG001|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2|"Dose 2: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle.~Dexamethasone at 40 mg was given orally on days 1, 8 and 15."
10801152|NCT02186834|EG002|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m|Dose 1m: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801153|NCT02186834|EG003|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m|Dose 2m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801154|NCT02186834|EG004|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m|Dose 3m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801155|NCT02186834|EG005|Reported Event|Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D|Phase 2 Dose: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
10801156|NCT02163733|BG000|Baseline|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
10801157|NCT02163733|BG001|Baseline|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
10801158|NCT02163733|BG002|Baseline|Total|Total of all reporting groups
10801159|NCT02163733|FG000|Participant Flow|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
10801160|NCT02163733|FG001|Participant Flow|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
10801161|NCT02163733|FG002|Participant Flow|AZD9291 Alone (Part B)|In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
10801162|NCT02163733|OG000|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
10801163|NCT02163733|OG001|Outcome|Fasted|AZD9291 tablets following a period of fasting
10801164|NCT02163733|EG000|Reported Event|Overall Safety Population|Parts A and B of the study combined.
10801165|NCT02163733|EG001|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).
10801166|NCT02163733|EG002|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
10801167|NCT01844505|BG000|Baseline|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
10801168|NCT01844505|BG001|Baseline|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
10801169|NCT01844505|BG002|Baseline|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
10801170|NCT01844505|BG003|Baseline|Total|Total of all reporting groups
10801171|NCT01844505|FG000|Participant Flow|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
10801172|NCT01844505|FG001|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
10801173|NCT01844505|FG002|Participant Flow|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
11193489|NCT02145468|BG000|Baseline|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11379204|NCT03600142|EG001|Reported Event|SoC + Stigma Counseling (Maisha)|"Participants randomized to the intervention condition (n=758) received the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated in the first two counseling sessions together with the woman.~Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention was developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement."
11379205|NCT03517722|BG000|Baseline|Placebo to Ustekinumab|Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
11379206|NCT03517722|BG001|Baseline|Ustekinumab|Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
11379207|NCT03517722|BG002|Baseline|Total|Total of all reporting groups
11379208|NCT03517722|FG000|Participant Flow|Placebo to Ustekinumab|Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
11379209|NCT03517722|FG001|Participant Flow|Ustekinumab|Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
11379210|NCT03517722|OG000|Outcome|Placebo to Ustekinumab|Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
11379211|NCT03517722|OG001|Outcome|Ustekinumab|Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
11379212|NCT03517722|EG000|Reported Event|Placebo (Prior to Entering (Long Term Extension [LTE])|Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) IV based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period.
11379213|NCT03517722|EG001|Reported Event|Placebo to Ustekinumab (After Entering LTE)|Participants who entered the open-label extension period at Week 52 crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
11379214|NCT03517722|EG002|Reported Event|Ustekinumab (Through Week 113)|Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to (<=) 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
11379215|NCT03499314|BG000|Baseline|RS-tDCS Stimulation|"20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee~Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379216|NCT03499314|BG001|Baseline|Sham Stimulation|"20 ×20-minute sessions sham tDCS~Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379217|NCT03499314|BG002|Baseline|Total|Total of all reporting groups
11379218|NCT03499314|FG000|Participant Flow|RS-tDCS Stimulation|"20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee~Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
10964485|NCT00877799|EG000|Reported Event|Cohort 1: Placebo|Matched placebo administered 24 hours after surgery (Day 1)
11193490|NCT02145468|BG001|Baseline|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11379219|NCT03499314|FG001|Participant Flow|Sham Stimulation|"20 ×20-minute sessions sham tDCS~Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379220|NCT03499314|OG000|Outcome|RS-tDCS Stimulation|"20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee~Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379221|NCT03499314|OG001|Outcome|Sham Stimulation|"20 ×20-minute sessions sham tDCS~Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379222|NCT03499314|EG000|Reported Event|RS-tDCS Stimulation|"20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee~Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379223|NCT03499314|EG001|Reported Event|Sham Stimulation|"20 ×20-minute sessions sham tDCS~Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds~Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training."
11379224|NCT03439124|BG000|Baseline|Ceftobiprole Medocaril|Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
11379225|NCT03439124|BG001|Baseline|IV Standard-of-care Cephalosporin|"Ceftriaxone was used as standard-of-care cephalosporin for the treatment of CAP. It is a third-generation cephalosporin with activity against typical bacterial pathogens of CAP requiring hospitalization, and is widely used for the treatment of various bacterial infections in neonates, infants, children, and adults.~Ceftazidime was used as standard-of-care cephalosporin for the treatment of HAP. It is also a third-generation cephalosporin, but with broader activity against Gram-negative aerobic bacilli, including Pseudomonas aeruginosa.~Vancomycin is a glycopeptide antibiotic that is active against staphylococci, including MRSA. At the discretion of the blinded investigator, patients received vancomycin in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
11379226|NCT03439124|BG002|Baseline|Total|Total of all reporting groups
11379227|NCT03439124|FG000|Participant Flow|Ceftobiprole Medocaril|Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
11379228|NCT03439124|FG001|Participant Flow|IV Standard-of-care Cephalosporin|"Ceftriaxone was used as standard-of-care cephalosporin for the treatment of community-acquired pneumonia (CAP). It is a third-generation cephalosporin with activity against typical bacterial pathogens of CAP requiring hospitalization, and is widely used for the treatment of various bacterial infections in neonates, infants, children, and adults.~Ceftazidime was used as standard-of-care cephalosporin for the treatment of hospital-acquired pneumonia (HAP). It is also a third-generation cephalosporin, but with broader activity against Gram-negative aerobic bacilli, including Pseudomonas aeruginosa.~Vancomycin is a glycopeptide antibiotic that is active against staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA). At the discretion of the blinded investigator, patients received vancomycin in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
11379229|NCT03439124|OG000|Outcome|Ceftobiprole Medocaril|Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
11379230|NCT03439124|OG001|Outcome|IV Standard-of-care Cephalosporin|"Ceftriaxone was used as standard-of-care cephalosporin for the treatment of CAP. It is a third-generation cephalosporin with activity against typical bacterial pathogens of CAP requiring hospitalization, and is widely used for the treatment of various bacterial infections in neonates, infants, children, and adults.~Ceftazidime was used as standard-of-care cephalosporin for the treatment of HAP. It is also a third-generation cephalosporin, but with broader activity against Gram-negative aerobic bacilli, including Pseudomonas aeruginosa.~Vancomycin is a glycopeptide antibiotic that is active against staphylococci, including MRSA. At the discretion of the blinded investigator, patients received vancomycin in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
11379231|NCT03439124|EG000|Reported Event|Ceftobiprole Medocaril|Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
10780196|NCT04160195|BG000|Baseline|1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation|"All participants will be receiving escalating dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780197|NCT04160195|BG001|Baseline|2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase|"Maximum tolerated dose (MTD) dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + Conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780198|NCT04160195|BG002|Baseline|Total|Total of all reporting groups
10780199|NCT04160195|FG000|Participant Flow|1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation|"All participants will be receiving escalating dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
11193491|NCT02145468|BG002|Baseline|Total|Total of all reporting groups
11193492|NCT02145468|FG000|Participant Flow|Placebo|Participants received losmapimod matching placebo tablets via oral route, twice daily (BID), according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
10780200|NCT04160195|FG001|Participant Flow|2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase|"Maximum tolerated dose (MTD) dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + Conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780201|NCT04160195|OG000|Outcome|1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation|"All participants will be receiving escalating dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780202|NCT04160195|OG001|Outcome|2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase|"Maximum tolerated dose (MTD) dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + Conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10801174|NCT01844505|OG000|Outcome|Nivolumab|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
11193493|NCT02145468|FG001|Participant Flow|Losmapimod 7.5 Mllligrms BID|Participants received losmapimod 7.5 milligrams (mg) tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11193494|NCT02145468|OG000|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11193495|NCT02145468|OG001|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11193496|NCT02145468|EG000|Reported Event|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
10780203|NCT04160195|OG000|Outcome|1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation|"All patients will be receiving escalating dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780204|NCT04160195|OG000|Outcome|All Participants|All participants treated on 1/Conditioning chemotherapy plus Chimeric Antigen Receptors (CAR) T-cells dose escalation and 2/Conditioning chemotherapy plus Chimeric Antigen Receptors (CAR) T-cells expansion phase.
10780205|NCT04160195|EG000|Reported Event|1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation|"All patients will be receiving escalating dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780206|NCT04160195|EG001|Reported Event|2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase|"Maximum tolerated dose (MTD) dose of Anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) CAR T cells/kg + Conditioning chemotherapy~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells: Dose-escalation trial starting dose: 0.66 x10^6 CAR+ T cells/kg (weight-based dosing one time) (up to a maximum dose of 10x10^6 CAR+ T cells/kg based on cohort) infuse on day 0~Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10780207|NCT04159701|BG000|Baseline|Sequence Group 1: (500 mg LY3454738, Placebo)|Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks followed by placebo for 12 weeks.
10780208|NCT04159701|BG001|Baseline|Sequence Group 2: (Placebo, 500 mg LY3454738)|Participants received Placebo for 12 weeks followed by 500 mg LY3454738 IV Q2W for 12 weeks.
10780209|NCT04159701|BG002|Baseline|Total|Total of all reporting groups
10780210|NCT04159701|FG000|Participant Flow|Sequence Group 1: (500 mg LY3454738, Placebo)|"Participants received 500 milligram (mg) LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks followed by placebo for 12 weeks.~Participants did not receive study drug during the follow-up period."
10780211|NCT04159701|FG001|Participant Flow|Sequence Group 2: (Placebo, 500 mg LY3454738)|"Participants received Placebo for 12 weeks followed by 500 mg LY3454738 IV Q2W for 12 weeks.~Participants did not receive study drug during the follow-up period."
10780212|NCT04159701|OG000|Outcome|Sequence Group 1: (500 mg LY3454738, Placebo)|Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks followed by placebo for 12 weeks.
10780213|NCT04159701|OG001|Outcome|Sequence Group 2: (Placebo, 500 mg LY3454738)|Participants received Placebo for 12 weeks followed by 500 mg LY3454738 IV Q2W for 12 weeks.
10780214|NCT04159701|OG000|Outcome|500 mg LY3454738|Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks.
10780215|NCT04159701|EG000|Reported Event|500 mg LY3454738_First 12-Week Period|Participants received 500 mg LY3454738 IV Q2W for 12 weeks.
10780216|NCT04159701|EG001|Reported Event|Placebo_First 12-Week Period|Participants received Placebo IV Q2W for 12 weeks.
10780217|NCT04159701|EG002|Reported Event|500 LY3454738_Second 12-Week Crossover Period|Participants received 500 mg LY3454738 IV Q2W for 12 weeks.
10780218|NCT04159701|EG003|Reported Event|Placebo_Second 12-Week Crossover Period|Participants received Placebo IV Q2W for 12 weeks.
10780219|NCT04159701|EG004|Reported Event|Follow-Up Period|Participants did not receive study drug during the follow-up period.
10801175|NCT01844505|OG001|Outcome|Nivolumab + Ipilimumab|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
10801176|NCT01844505|OG002|Outcome|Ipilimumab|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
10801177|NCT01844505|EG000|Reported Event|NIVOLUMAB|Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
10801178|NCT01844505|EG001|Reported Event|NIVOLUMAB+IPILIMUMAB|Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
10801179|NCT01844505|EG002|Reported Event|IPILIMUMAB|Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
10801180|NCT01781390|BG000|Baseline|Placebo|Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
10801181|NCT01781390|BG001|Baseline|Mesenchymal Precursor Cells (MPC) 12.5 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
10801182|NCT01781390|BG002|Baseline|Mesenchymal Precursor Cells (MPC) 25 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
10801183|NCT01781390|BG003|Baseline|Total|Total of all reporting groups
10801184|NCT01781390|FG000|Participant Flow|Placebo|Participants received matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
10964486|NCT00877799|EG001|Reported Event|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)
10780220|NCT04152447|BG000|Baseline|Standard of Care|"The usual care for pain management at our institution consists of standing Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing MGH nursing protocols evaluate when to give PRN narcotics to patients based on functional pain levels and are aimed at minimizing narcotic use. In elderly patients, the PRN dose of narcotics prescribed is generally half that of their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in younger patients).~Geriatric fracture patients admitted to the orthopaedic trauma service are comanaged with geriatricians who also carefully monitor the effects of these medications. In this manner, the standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded."
10780221|NCT04152447|BG001|Baseline|VR Device|VR device: Patients use a VR device
10780222|NCT04152447|BG002|Baseline|Total|Total of all reporting groups
10780223|NCT04152447|FG000|Participant Flow|Standard of Care|The standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded. In this study, we follow MGH nursing protocols for the group receiving the standard of care.
10780224|NCT04152447|FG001|Participant Flow|VR Device|VR device: Patients use a VR device
10780225|NCT04152447|OG000|Outcome|Standard of Care|"The usual care for pain management at our institution consists of standing Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing MGH nursing protocols evaluate when to give PRN narcotics to patients based on functional pain levels and are aimed at minimizing narcotic use. In elderly patients, the PRN dose of narcotics prescribed is generally half that of their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in younger patients).~Geriatric fracture patients admitted to the orthopaedic trauma service are comanaged with geriatricians who also carefully monitor the effects of these medications. In this manner, the standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded."
10780226|NCT04152447|OG001|Outcome|VR Device|VR device: Patients use a VR device
10780227|NCT04152447|EG000|Reported Event|Standard of Care|"The usual care for pain management at our institution consists of standing Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing MGH nursing protocols evaluate when to give PRN narcotics to patients based on functional pain levels and are aimed at minimizing narcotic use. In elderly patients, the PRN dose of narcotics prescribed is generally half that of their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in younger patients).~Geriatric fracture patients admitted to the orthopaedic trauma service are comanaged with geriatricians who also carefully monitor the effects of these medications. In this manner, the standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded."
10780228|NCT04152447|EG001|Reported Event|VR Device|VR device: Patients use a VR device
10964487|NCT00877799|EG002|Reported Event|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)
10964488|NCT00877799|EG003|Reported Event|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
10801185|NCT01781390|FG001|Participant Flow|Mesenchymal Precursor Cells (MPC) 12.5 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
10801186|NCT01781390|FG002|Participant Flow|Mesenchymal Precursor Cells (MPC) 25 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
10801187|NCT01781390|OG000|Outcome|Placebo|Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
10801188|NCT01781390|OG001|Outcome|Mesenchymal Precursor Cells (MPC) 12.5 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
10801189|NCT01781390|OG002|Outcome|Mesenchymal Precursor Cells (MPC) 25 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
10801190|NCT01781390|EG000|Reported Event|Placebo|Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 mins including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
10801191|NCT01781390|EG001|Reported Event|Mesenchymal Precursor Cells (MPC) 12.5 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (2.5x10^5 MPCs/min) on Day 0.
10801192|NCT01781390|EG002|Reported Event|Mesenchymal Precursor Cells (MPC) 25 M|Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (5.0x10^5 MPCs/min) on Day 0.
10801193|NCT01701674|BG000|Baseline|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
10801194|NCT01701674|FG000|Participant Flow|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
10801195|NCT01701674|OG000|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
10801196|NCT01701674|EG000|Reported Event|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
10801197|NCT01640301|BG000|Baseline|Arm I (High-risk for Relapse After HCT)|"Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10803704|NCT02476006|FG000|Participant Flow|Alirocumab|Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (LMT) up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
10780229|NCT04150107|BG000|Baseline|Placebo Followed by Treatment A Followed by Treatment B|"Treatment administerd in the following order:~Placebo, standard of care Fish oil capsules~Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801 ORMD-0801: Oral Insulin Capsules~Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals ORMD-0801: Oral Insulin Capsules"
10780230|NCT04150107|BG001|Baseline|Placebo Followed by Treatment B Followed by Treatment A|"Treatment administerd in the following order:~Placebo, standard of care Fish oil capsules~Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals ORMD-0801: Oral Insulin Capsules~Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801 ORMD-0801: Oral Insulin Capsules"
10780231|NCT04150107|BG002|Baseline|Total|Total of all reporting groups
10780232|NCT04150107|FG000|Participant Flow|Placebo Followed by Treatment A Followed by Treatment B|"Treatment administered in the following order:~Placebo Fish oil capsule~Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801 ORMD-0801: Oral Insulin Capsules~Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals ORMD-0801: Oral Insulin Capsules"
10780233|NCT04150107|FG001|Participant Flow|Placebo Followed by Treatment B Followed by Treatment A|"Treatment administered in the following order:~Placebo Fish oil capsule~Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals ORMD-0801: Oral Insulin Capsules~Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801 ORMD-0801: Oral Insulin Capsules"
10780234|NCT04150107|OG000|Outcome|Baseline|Placebo (Fish-Oil Capsule)
10780235|NCT04150107|OG001|Outcome|Treatment A|"Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801~ORMD-0801: Oral Insulin Capsules"
10780236|NCT04150107|OG002|Outcome|Treatment B|"Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals~ORMD-0801: Oral Insulin Capsules"
10780237|NCT04150107|EG000|Reported Event|Placebo|Placebo - Fish Oil
10780238|NCT04150107|EG001|Reported Event|Treatment A ORMD-0801|"Treatment A is 24 mg (16 mg + 8 mg capsules) Once Daily (QD) at Bedtime of ORMD-0801~ORMD-0801 Treatment A: Treatment A: 24 mg (16 mg capsule + 8 mg capsule) Once Daily (QD) at bedtime"
10780239|NCT04150107|EG002|Reported Event|Treatment B ORMD-0801|"Treatment B is 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals~ORMD-0801 Treatment B: Treatment B: 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals"
10801198|NCT01640301|BG001|Baseline|Arm II (Relapsed After HCT)|"Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801199|NCT01640301|BG002|Baseline|Total|Total of all reporting groups
10801200|NCT01640301|FG000|Participant Flow|Arm I (High-risk for Relapse After HCT)|"Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801201|NCT01640301|FG001|Participant Flow|Arm II (Relapsed After HCT)|"Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801202|NCT01640301|OG000|Outcome|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
10801203|NCT01640301|OG000|Outcome|Group 1 (Avelumab and MHC Class I Up-regulation)|Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.
10801204|NCT01640301|OG000|Outcome|Arm I (High-risk for Relapse After HCT)|"Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801205|NCT01640301|OG001|Outcome|Arm II (Relapsed After HCT)|"Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801206|NCT01640301|EG000|Reported Event|Arm I (High-risk for Relapse After HCT)|"Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10801207|NCT01640301|EG001|Reported Event|Arm II (Relapsed After HCT)|"Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28.~Aldesleukin: Given SC~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~WT1-Sensitized Allogeneic T-Lymphocytes: Given IV"
10780266|NCT04460183|BG000|Baseline|RESP301+SoC|Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC).
10780267|NCT04460183|BG001|Baseline|Standard of Care (SoC)|Participants received institutional SOC alone for the treatment of COVID-19.
10780268|NCT04460183|BG002|Baseline|Total|Total of all reporting groups
10780269|NCT04460183|FG000|Participant Flow|RESP301+SoC|Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC).
10780270|NCT04460183|FG001|Participant Flow|Standard of Care (SoC)|Participants received institutional SOC alone for the treatment of COVID-19.
10780271|NCT04460183|OG000|Outcome|RESP301+SoC|Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC).
10780272|NCT04460183|OG001|Outcome|Standard of Care (SoC)|Participants received institutional SOC alone for the treatment of COVID-19.
10780273|NCT04460183|EG000|Reported Event|RESP301+SoC|Participants received inhaled RESP301 administered using a nebulizer three times a day (TID) for up to 10 days in addition to the standard of care (SoC).
10780274|NCT04460183|EG001|Reported Event|Standard of Care (SoC) Standard of Care (SoC)|Participants received institutional SOC alone for the treatment of COVID-19.
10780275|NCT04421027|BG000|Baseline|Placebo +SOC|Placebo administered orally QD with standard of care.
10780276|NCT04421027|BG001|Baseline|Baricitinib + SOC|4 mg baricitinib administered orally QD with standard of care.
10780277|NCT04421027|BG002|Baseline|Total|Total of all reporting groups
10780278|NCT04421027|FG000|Participant Flow|Placebo + Standard of Care (SOC)|Placebo tablets administered orally every day (QD) with standard of care.
10780279|NCT04421027|FG001|Participant Flow|Baricitinib + SOC|4 milligrams (mg) baricitinib administered orally QD with standard of care.
10780280|NCT04421027|OG000|Outcome|Placebo + SOC|Placebo administered orally QD with standard of care.
10780281|NCT04421027|OG001|Outcome|Baricitinib + SOC|4 mg baricitinib administered orally QD with standard of care.
10780282|NCT04421027|EG000|Reported Event|Placebo|Placebo tablets administered orally every day (QD) with standard of care.
10780283|NCT04421027|EG001|Reported Event|4 Milligrams (mg) Baricitinib|4 milligrams (mg) baricitinib administered orally QD with standard of care.
10780284|NCT04421027|EG002|Reported Event|Placebo Follow-up|Placebo tablets administered orally QD with standard of care.
10780285|NCT04421027|EG003|Reported Event|4mg Baricitinib Follow-up|4 mg baricitinib administered orally QD with standard of care.
10964489|NCT00877799|EG004|Reported Event|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
10964490|NCT00877877|BG000|Baseline|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
10964491|NCT00877877|FG000|Participant Flow|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
10964492|NCT00877877|OG000|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
10780290|NCT03831360|BG000|Baseline|Hatha Yoga|"12 weeks of hatha yoga~Yoga: Hatha yoga for depressed adolescents"
10964493|NCT00877877|EG000|Reported Event|Cervarix Group From Month 48 Until Month 60|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
10780291|NCT03831360|BG001|Baseline|Group CBT|"12 weeks of group CBT~Group CBT: Group cognitive behavioral therapy for depressed adolescents"
10780292|NCT03831360|BG002|Baseline|Total|Total of all reporting groups
10780293|NCT03831360|FG000|Participant Flow|Hatha Yoga|"12 weeks of hatha yoga~Yoga: Hatha yoga for depressed adolescents"
10780294|NCT03831360|FG001|Participant Flow|Group CBT|"12 weeks of group CBT~Group CBT: Group cognitive behavioral therapy for depressed adolescents"
10780295|NCT03831360|OG000|Outcome|Hatha Yoga|"12 weeks of hatha yoga~Yoga: Hatha yoga for depressed adolescents"
10780296|NCT03831360|OG001|Outcome|Group CBT|"12 weeks of group CBT~Group CBT: Group cognitive behavioral therapy for depressed adolescents"
10780297|NCT03831360|EG000|Reported Event|Hatha Yoga|"12 weeks of hatha yoga~Yoga: Hatha yoga for depressed adolescents"
10780298|NCT03831360|EG001|Reported Event|Group CBT|"12 weeks of group CBT~Group CBT: Group cognitive behavioral therapy for depressed adolescents"
10780299|NCT03829332|BG000|Baseline|Pembrolizumab + Lenvatinib|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780300|NCT03829332|BG001|Baseline|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780301|NCT03829332|BG002|Baseline|Total|Total of all reporting groups
10780302|NCT03829332|FG000|Participant Flow|Pembrolizumab + Lenvatinib|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780303|NCT03829332|FG001|Participant Flow|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780304|NCT03829332|OG000|Outcome|Pembrolizumab + Lenvatinib|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780305|NCT03829332|OG001|Outcome|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780306|NCT03829332|EG000|Reported Event|Lenvatinib + Pembrolizumab|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780307|NCT03829332|EG001|Reported Event|Placebo + Pembrolizumab|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
10780308|NCT03813121|BG000|Baseline|Placebo Intravenous Infusion|"single placebo infusion (saline over 20 minutes)~placebo intravenous infusion: Participants will receive a single placebo infusion"
10780309|NCT03813121|BG001|Baseline|Ketamine Intravenous Infusion|"single ketamine infusion (0.5 mg/kg over 20 minutes)~ketamine intravenous infusion: Participants will receive a single drug infusion"
10780310|NCT03813121|BG002|Baseline|Total|Total of all reporting groups
10780311|NCT03813121|FG000|Participant Flow|Placebo Intravenous Infusion|"single placebo infusion (saline over 20 minutes)~placebo intravenous infusion: Participants will receive a single placebo infusion"
10780312|NCT03813121|FG001|Participant Flow|Ketamine Intravenous Infusion|"single ketamine infusion (0.5 mg/kg over 20 minutes)~ketamine intravenous infusion: Participants will receive a single drug infusion"
10780313|NCT03813121|OG000|Outcome|Placebo Intravenous Infusion|"single placebo infusion (saline over 20 minutes)~placebo intravenous infusion: Participants will receive a single placebo infusion"
10780314|NCT03813121|OG001|Outcome|Ketamine Intravenous Infusion|"single ketamine infusion (0.5 mg/kg over 20 minutes)~ketamine intravenous infusion: Participants will receive a single drug infusion"
10780315|NCT03813121|EG000|Reported Event|Placebo Intravenous Infusion|"single placebo infusion (saline over 20 minutes)~placebo intravenous infusion: Participants will receive a single placebo infusion"
10780316|NCT03813121|EG001|Reported Event|Ketamine Intravenous Infusion|"single ketamine infusion (0.5 mg/kg over 20 minutes)~ketamine intravenous infusion: Participants will receive a single drug infusion"
10801208|NCT01575860|BG000|Baseline|Maintenance Lenalidomide in Lymphoma|Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily.
10801209|NCT01575860|FG000|Participant Flow|Maintenance Lenalidomide in Lymphoma|Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
10801210|NCT01575860|OG000|Outcome|Maintenance Lenalidomide in Lymphoma|Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
10801211|NCT01575860|OG000|Outcome|Maintenance Lenalidomide in Lymphoma|Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily.
10801212|NCT01575860|EG000|Reported Event|Maintenance Lenalidomide in Lymphoma|"Total of twenty-four (24) 28-day cycles of lenalidomide, 10mg, oral tablets, daily~Lenalidomide: Lenalidomide, 10mg, oral tablets, daily"
10801213|NCT01402908|BG000|Baseline|PI-88|"Arm 1~PI-88: Lyophilized powder reconstituted to provide 160 mg of PI-88"
10801214|NCT01402908|BG001|Baseline|Placebo|"Arm 2~Placebo: Lactose lyophilized powder"
10801215|NCT01402908|BG002|Baseline|Total|Total of all reporting groups
10801216|NCT01402908|FG000|Participant Flow|PI-88|"Arm 1~PI-88: Lyophilized powder reconstituted to provide 160 mg of PI-88"
11193497|NCT02145468|EG001|Reported Event|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
11193498|NCT02145676|BG000|Baseline|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
10780326|NCT03635099|BG000|Baseline|Part I - Placebo (Fasted)|Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
11193499|NCT02145676|BG001|Baseline|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
10801217|NCT01402908|FG001|Participant Flow|Placebo|"Arm 2~Placebo: Lactose lyophilized powder"
10801218|NCT01402908|OG000|Outcome|PI-88|"Arm 1~PI-88: Lyophilized powder reconstituted to provide 160 mg of PI-88"
11193500|NCT02145676|BG002|Baseline|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
11193501|NCT02145676|BG003|Baseline|Total|Total of all reporting groups
11193502|NCT02145676|FG000|Participant Flow|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
11193503|NCT02145676|FG001|Participant Flow|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
11193504|NCT02145676|FG002|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
11193505|NCT02145676|OG000|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
11193506|NCT02145676|OG001|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
10780327|NCT03635099|BG001|Baseline|Part I - BI 25 mg (Fasted)|Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780328|NCT03635099|BG002|Baseline|Part I - BI 50 mg (Fasted)|Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780329|NCT03635099|BG003|Baseline|Part I - BI 100 mg (Fasted)|Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780330|NCT03635099|BG004|Baseline|Part I - BI 200 mg (Fasted)|Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
10780331|NCT03635099|BG005|Baseline|Part II - Placebo (Fed)|Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780332|NCT03635099|BG006|Baseline|Part II - BI 400 mg Once Daily (Fed)|Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780333|NCT03635099|BG007|Baseline|Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)|Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
10780334|NCT03635099|BG008|Baseline|Total|Total of all reporting groups
10780335|NCT03635099|FG000|Participant Flow|Part I - Placebo (Fasted)|Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780336|NCT03635099|FG001|Participant Flow|Part I - BI 25 mg (Fasted)|Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
11193507|NCT02145676|OG002|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
10780337|NCT03635099|FG002|Participant Flow|Part I - BI 50 mg (Fasted)|Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780338|NCT03635099|FG003|Participant Flow|Part I - BI 100 mg (Fasted)|Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780339|NCT03635099|FG004|Participant Flow|Part I - BI 200 mg (Fasted)|Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
11193508|NCT02145676|EG000|Reported Event|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
10780340|NCT03635099|FG005|Participant Flow|Part II - Placebo (Fed)|Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780341|NCT03635099|FG006|Participant Flow|Part II - BI 400 mg Once Daily (Fed)|Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780342|NCT03635099|FG007|Participant Flow|Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)|Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
10780343|NCT03635099|OG000|Outcome|Part I - Placebo (Fasted)|Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10801219|NCT01402908|OG001|Outcome|Placebo|"Arm 2~Placebo: Lactose lyophilized powder"
11193509|NCT02145676|EG001|Reported Event|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
10780344|NCT03635099|OG001|Outcome|Part I - BI 25 mg (Fasted)|Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780345|NCT03635099|OG002|Outcome|Part I - BI 50 mg (Fasted)|Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780346|NCT03635099|OG003|Outcome|Part I - BI 100 mg (Fasted)|Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
10780347|NCT03635099|OG004|Outcome|Part I - BI 200 mg (Fasted)|Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
10780348|NCT03635099|OG005|Outcome|Part II - Placebo (Fed)|Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780349|NCT03635099|OG006|Outcome|Part II - BI 400 mg Once Daily (Fed)|Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780350|NCT03635099|OG007|Outcome|Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)|Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
10780351|NCT03635099|EG000|Reported Event|Part I - Period 1 - Fasted: Placebo|Part I - Period 1 - fasted: Placebo matching BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
10780352|NCT03635099|EG001|Reported Event|Part I - Period 1 - Fasted: BI 25 mg|Part I - Period 1 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
10780353|NCT03635099|EG002|Reported Event|Part I - Period 1 - Fasted: BI 50 mg|Part I - Period 1 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
10780354|NCT03635099|EG003|Reported Event|Part I - Period 1 - Fasted: BI 100 mg|Part I - Period 1 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
11193510|NCT02145676|EG002|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
10780355|NCT03635099|EG004|Reported Event|Part I - Period 1 - Fasted: BI 200 mg|Part I - Period 1 - fasted: 200 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
10780356|NCT03635099|EG005|Reported Event|Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg|Part I - Period 1 and 2 - fasted: Placebo participants in period who failed to achieve a PASI 75 response at Week 12 and were switched to a 200 mg dose in period 2.
10780357|NCT03635099|EG006|Reported Event|Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg|Part I - Period 1 and 2 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 25 mg dose in period 2.
10780358|NCT03635099|EG007|Reported Event|Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg|Part I - Period 1 and 2 - fasted: Participants assigned 25 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 50 mg dose in period 2.
10780359|NCT03635099|EG008|Reported Event|Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg|Part I - Period 1 and 2 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 50 mg dose in period 2.
10780360|NCT03635099|EG009|Reported Event|Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg|Part I - Period 1 and 2 - fasted: Participants assigned 50 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 100 mg dose in period 2.
10780361|NCT03635099|EG010|Reported Event|Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg|Part I - Period 1 and 2 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 100 mg dose in period 2.
10780362|NCT03635099|EG011|Reported Event|Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg|Part I - Period 1 and 2 - fasted: Participants assigned 100 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 200 mg dose in period 2.
10780363|NCT03635099|EG012|Reported Event|Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg|Part I - Period 1 and 2 - fasted: Participants assigned 200 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who remained on the 200 mg throughout period 1 and 2.
10780364|NCT03635099|EG013|Reported Event|Part II - Placebo (Fed)|Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780365|NCT03635099|EG014|Reported Event|Part II - BI 400 mg Once Daily (Fed)|Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
10780366|NCT03635099|EG015|Reported Event|Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)|Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
11193511|NCT02145754|BG000|Baseline|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
11193512|NCT02145754|FG000|Participant Flow|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media~MKP media versus BSK-H media"
10780367|NCT03543046|BG000|Baseline|Tortle Midliner|"The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.~Tortle Midliner: The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life."
10780368|NCT03543046|BG001|Baseline|Control Group|All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements.
10780369|NCT03543046|BG002|Baseline|Total|Total of all reporting groups
10780370|NCT03543046|FG000|Participant Flow|Tortle Midliner|"The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.~Tortle Midliner: The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life."
10780371|NCT03543046|FG001|Participant Flow|Control Group|All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements.
10780372|NCT03543046|OG000|Outcome|Tortle Midliner|"The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.~Tortle Midliner: The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life."
11193513|NCT02145754|OG000|Outcome|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
10780373|NCT03543046|OG001|Outcome|Control Group|All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements.
10964494|NCT00877877|EG001|Reported Event|Cervarix Group From Month 60 Until Month 72|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
11193514|NCT02145754|EG000|Reported Event|MKP Media Versus BSK-h Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
11193515|NCT02146001|BG000|Baseline|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
11193516|NCT02146001|BG001|Baseline|Sit Less|Targeting 1 hour less of sedentary time per day
11193517|NCT02146001|BG002|Baseline|Total|Total of all reporting groups
11193518|NCT02146001|FG000|Participant Flow|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
11193519|NCT02146001|FG001|Participant Flow|Sit Less|Targeting 1 hour less of sedentary time per day
10780374|NCT03543046|EG000|Reported Event|Tortle Midliner|"The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.~Tortle Midliner: The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life."
10780375|NCT03543046|EG001|Reported Event|Control Group|All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements.
10780376|NCT03542877|BG000|Baseline|Oral Cabozantinib|"Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.~Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame."
10780377|NCT03542877|FG000|Participant Flow|Oral Cabozantinib|"Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.~Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame."
10780378|NCT03542877|OG000|Outcome|Oral Cabozantinib|"Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.~Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame."
10780379|NCT03542877|OG000|Outcome|RAS Mutant|Subjects who were RAS mutant.
10780380|NCT03542877|OG001|Outcome|RAS Wild Type|Subjects with wild type RAS mutation status
10780381|NCT03542877|OG000|Outcome|PIK3CA Mutant|Subjects who were PIK3CA mutant.
10780382|NCT03542877|OG001|Outcome|PIK3CA Wild Type|Subjects with wild type PIK3CA mutation status.
11193520|NCT02146001|OG000|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
10780383|NCT03542877|EG000|Reported Event|Oral Cabozantinib|"Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.~Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame."
10780384|NCT03530800|BG000|Baseline|Dronabinol|"Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary.~Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)"
10780385|NCT03530800|BG001|Baseline|Placebo|"Subjects will receive placebo for 10 weeks weeks.~Placebo: Placebo for 10 weeks"
10780386|NCT03530800|BG002|Baseline|Total|Total of all reporting groups
10780387|NCT03530800|FG000|Participant Flow|Dronabinol|"Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary.~Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)"
10780388|NCT03530800|FG001|Participant Flow|Placebo|"Subjects will receive placebo for 10 weeks weeks.~Placebo: Placebo for 10 weeks"
10780389|NCT03530800|OG000|Outcome|Dronabinol|"Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary.~Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)"
10780390|NCT03530800|OG001|Outcome|Placebo|"Subjects will receive placebo for 10 weeks weeks.~Placebo: Placebo for 10 weeks"
10780391|NCT03530800|EG000|Reported Event|Dronabinol|"Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary.~Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)"
10780392|NCT03530800|EG001|Reported Event|Placebo|"Subjects will receive placebo for 10 weeks weeks.~Placebo: Placebo for 10 weeks"
10801220|NCT01402908|EG000|Reported Event|PI-88|"Arm 1~PI-88: Lyophilized powder reconstituted to provide 160 mg of PI-88~In the safety population, the subjects were analyzed according to the actual treatment received and must have received at least one dose of study medication.~A total of 258 subjects were included in the safety population."
11193521|NCT02146001|OG001|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
11193522|NCT02146001|EG000|Reported Event|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
11193523|NCT02146001|EG001|Reported Event|Sit Less|Targeting 1 hour less of sedentary time per day
11193524|NCT02146105|BG000|Baseline|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
10780393|NCT03270462|BG000|Baseline|Envarsus XR|"A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.~Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms."
10780394|NCT03270462|FG000|Participant Flow|Envarsus XR|"A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.~Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms."
10780395|NCT03270462|OG000|Outcome|Envarsus XR|"A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.~Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms."
10780396|NCT03270462|EG000|Reported Event|Envarsus XR|"A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.~Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms."
11193525|NCT02146105|FG000|Participant Flow|Yoga Intervention|Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
11193526|NCT02146105|OG000|Outcome|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
11193527|NCT02146105|EG000|Reported Event|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
10780401|NCT03100149|BG000|Baseline|Part 1: Placebo|"Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780402|NCT03100149|BG001|Baseline|Part 1: RO7046015 Low Dose|"Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780403|NCT03100149|BG002|Baseline|Part 1: RO7046015 High Dose|"Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose."
10780404|NCT03100149|BG003|Baseline|Total|Total of all reporting groups
10780405|NCT03100149|FG000|Participant Flow|Part 1: Placebo|"Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780406|NCT03100149|FG001|Participant Flow|Part 1: RO7046015 Low Dose|"Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780407|NCT03100149|FG002|Participant Flow|Part 1: RO7046015 High Dose|"Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose."
10803705|NCT02476006|OG000|Outcome|Alirocumab|Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
10803706|NCT02476006|EG000|Reported Event|Alirocumab|Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
10803707|NCT02468414|BG000|Baseline|Group A|TARGTEPO 18-25 IU/kg/day
10803708|NCT02468414|BG001|Baseline|Group B|TARGTEPO 35-45 IU/kg/day
10803709|NCT02468414|BG002|Baseline|Total|Total of all reporting groups
10803710|NCT02468414|FG000|Participant Flow|Group A|18-25 IU/Kg/day
10803711|NCT02468414|FG001|Participant Flow|Group B|35-45 IU/Kg/day
10803712|NCT02468414|OG000|Outcome|Group A|TARGTEPO 18-25 IU/kg/day
10803713|NCT02468414|OG001|Outcome|Group B|TARGTEPO 35-45 IU/kg/day
10780408|NCT03100149|OG000|Outcome|Part 1: Placebo|"Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780409|NCT03100149|OG001|Outcome|Part 1: RO7046015 Low Dose|"Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780410|NCT03100149|OG002|Outcome|Part 1: RO7046015 High Dose|"Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose."
10780411|NCT03100149|EG000|Reported Event|Part 1: Placebo|"Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780412|NCT03100149|EG001|Reported Event|Part 1: RO7046015 Low Dose|"Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose."
10780413|NCT03100149|EG002|Reported Event|Part 1: RO7046015 High Dose|"Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1.~Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose."
10780414|NCT03090412|BG000|Baseline|Arm I (Surgery)|"Patients undergo standard of care surgery on day 1.~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo standard of care surgery"
10780415|NCT03090412|BG001|Baseline|Arm II (HPPH, PDT)|"Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.~HPPH: Given IV~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo PDT~Quality-of-Life Assessment: Ancillary studies"
10780416|NCT03090412|BG002|Baseline|Total|Total of all reporting groups
10780417|NCT03090412|FG000|Participant Flow|Arm I (Surgery)|"Patients undergo standard of care surgery on day 1.~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo standard of care surgery"
10780418|NCT03090412|FG001|Participant Flow|Arm II (HPPH, PDT)|"Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.~HPPH: Given IV~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo PDT~Quality-of-Life Assessment: Ancillary studies"
10780419|NCT03090412|OG000|Outcome|Arm I (Surgery)|"Patients undergo standard of care surgery on day 1.~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo standard of care surgery"
10780420|NCT03090412|OG001|Outcome|Arm II (HPPH, PDT)|"Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.~HPPH: Given IV~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo PDT~Quality-of-Life Assessment: Ancillary studies"
10780421|NCT03090412|EG000|Reported Event|Arm I (Surgery)|"Patients undergo standard of care surgery on day 1.~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo standard of care surgery"
10780422|NCT03090412|EG001|Reported Event|Arm II (HPPH, PDT)|"Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.~HPPH: Given IV~Laboratory Biomarker Analysis: Correlative studies~Photodynamic Therapy: Undergo PDT~Quality-of-Life Assessment: Ancillary studies"
10780423|NCT03065517|BG000|Baseline|VillageWhere App|"Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.~VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents."
10780424|NCT03065517|BG001|Baseline|Attention-Control Placebo App|"Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial.~Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms."
10780425|NCT03065517|BG002|Baseline|Total|Total of all reporting groups
10801221|NCT01402908|EG001|Reported Event|Placebo|"Arm 2~Placebo: Lactose lyophilized powder~In the safety population, the subjects were analyzed according to the actual treatment received and must have received at least one dose of study medication.~Because one subject withdrew the consent before treatment, a total of 260 subjects were included in the safety population."
10803714|NCT02468414|EG000|Reported Event|Group A|TARGTEPO 18-25 IU/kg/day
10780426|NCT03065517|FG000|Participant Flow|VillageWhere App|"Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.~VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents."
10780427|NCT03065517|FG001|Participant Flow|Attention-Control Placebo App|"Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial.~Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms."
10780428|NCT03065517|OG000|Outcome|VillageWhere App|"Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.~VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents."
10780429|NCT03065517|OG001|Outcome|Attention-Control Placebo App|"Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial.~Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms."
10780430|NCT03065517|EG000|Reported Event|VillageWhere App|"Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day.~VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents."
10780431|NCT03065517|EG001|Reported Event|Attention-Control Placebo App|"Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial.~Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms."
10780432|NCT03063203|BG000|Baseline|Decitabine|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780433|NCT03063203|FG000|Participant Flow|Decitabine|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780434|NCT03063203|OG000|Outcome|Decitabine|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780435|NCT03063203|OG000|Outcome|Morphologically Evident Disease|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780436|NCT03063203|OG001|Outcome|Molecularly Detected Disease|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780437|NCT03063203|OG000|Outcome|Patients With de Novo AML|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10801222|NCT01397201|BG000|Baseline|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10803715|NCT02468414|EG001|Reported Event|Group B|TARGTEPO 35-45 IU/kg/day
10780438|NCT03063203|OG001|Outcome|Patients With Secondary AML|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780439|NCT03063203|OG002|Outcome|Patients With Treatment Related AML|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780440|NCT03063203|OG000|Outcome|Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780441|NCT03063203|OG001|Outcome|Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780442|NCT03063203|EG000|Reported Event|Decitabine|"Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle~Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.~Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle"
10780443|NCT02831764|BG000|Baseline|DTG + 3TC|Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
10780444|NCT02831764|BG001|Baseline|DTG + TDF/FTC|Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
10780445|NCT02831764|BG002|Baseline|Total|Total of all reporting groups
10780446|NCT02831764|FG000|Participant Flow|DTG + 3TC|Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
10780447|NCT02831764|FG001|Participant Flow|DTG + TDF/FTC|Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 48 weeks.
10780448|NCT02831764|OG000|Outcome|DTG + 3TC|Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
10780449|NCT02831764|OG001|Outcome|DTG + TDF/FTC|Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
10780450|NCT02831764|EG000|Reported Event|DTG + 3TC|Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks
10780451|NCT02831764|EG001|Reported Event|DTG + TDF/FTC|Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks
10780452|NCT02722941|BG000|Baseline|Cohort A: Maintenance Therapy|"Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780453|NCT02722941|BG001|Baseline|Cohort B: Maintenance Therapy|"Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780454|NCT02722941|BG002|Baseline|Total|Total of all reporting groups
10780455|NCT02722941|FG000|Participant Flow|Cohort A: Maintenance Therapy|"Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780456|NCT02722941|FG001|Participant Flow|Cohort B: Maintenance Therapy|"Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780457|NCT02722941|OG000|Outcome|Cohort A: Maintenance Therapy|"Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780458|NCT02722941|OG001|Outcome|Cohort B: Maintenance Therapy|"Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780459|NCT02722941|EG000|Reported Event|Cohort A: Maintenance Therapy|"Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780460|NCT02722941|EG001|Reported Event|Cohort B: Maintenance Therapy|"Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule.~Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B."
10780461|NCT02655692|BG000|Baseline|Placebo|"Saline dose~Placebo: This is a saline placebo/non-active solution."
10780462|NCT02655692|BG001|Baseline|Low Dose Ketamine|"Low Dose Ketamine (.20 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780463|NCT02655692|BG002|Baseline|High Dose Ketamine|"High Dose Ketamine (.50 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780464|NCT02655692|BG003|Baseline|Total|Total of all reporting groups
10780465|NCT02655692|FG000|Participant Flow|Placebo|"Saline dose~Placebo: This is a saline placebo/non-active solution."
10780466|NCT02655692|FG001|Participant Flow|Low Dose Ketamine|"Low Dose Ketamine (.20 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780467|NCT02655692|FG002|Participant Flow|High Dose Ketamine|"High Dose Ketamine (.50 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780468|NCT02655692|OG000|Outcome|Placebo|"Saline dose~Placebo: This is a saline placebo/non-active solution."
10780469|NCT02655692|OG001|Outcome|Low Dose Ketamine|"Low Dose Ketamine (.20 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780470|NCT02655692|OG002|Outcome|High Dose Ketamine|"High Dose Ketamine (.50 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780471|NCT02655692|EG000|Reported Event|Placebo|"Saline dose~Placebo: This is a saline placebo/non-active solution."
10780472|NCT02655692|EG001|Reported Event|Low Dose Ketamine|"Low Dose Ketamine (.20 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780473|NCT02655692|EG002|Reported Event|High Dose Ketamine|"High Dose Ketamine (.50 mg/kg)~Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects."
10780474|NCT02623205|BG000|Baseline|Escitalopram|"Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)~Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission."
10780475|NCT02623205|BG001|Baseline|Placebo|"Lactose pill manufactured to mimic Escitalopram pill~Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders."
10780476|NCT02623205|BG002|Baseline|Total|Total of all reporting groups
10780477|NCT02623205|FG000|Participant Flow|Escitalopram|"Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)~Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission."
10780478|NCT02623205|FG001|Participant Flow|Placebo|"Lactose pill manufactured to mimic Escitalopram pill~Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of selective serotonin reuptake inhibitor (SSRI) treatment to placebo non-responders."
10780479|NCT02623205|OG000|Outcome|Escitalopram|"Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)~Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission."
10780480|NCT02623205|OG001|Outcome|Placebo|"Lactose pill manufactured to mimic Escitalopram pill~Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders."
10780481|NCT02623205|EG000|Reported Event|Escitalopram|"Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)~Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission."
10780482|NCT02623205|EG001|Reported Event|Placebo|"Lactose pill manufactured to mimic Escitalopram pill~Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders."
10780483|NCT02574481|BG000|Baseline|ELUVIA Stent Implantation|"Percutaneous stent placement in the SFA/PPA~ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780484|NCT02574481|BG001|Baseline|Zilver PTX Stent Implantation|"Percutaneous stent placement in the SFA/PPA~Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780485|NCT02574481|BG002|Baseline|Long Lesion Substudy|Long Lesion Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780486|NCT02574481|BG003|Baseline|PK Substudy|PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
10780487|NCT02574481|BG004|Baseline|Total|Total of all reporting groups
10780488|NCT02574481|FG000|Participant Flow|ELUVIA Stent Implantation|"Percutaneous stent placement in the SFA/PPA~ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780489|NCT02574481|FG001|Participant Flow|Zilver PTX Stent Implantation|"Percutaneous stent placement in the SFA/PPA~Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780490|NCT02574481|FG002|Participant Flow|Long Lesion Substudy|Long Lesions Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780491|NCT02574481|FG003|Participant Flow|PK Substudy|PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
10780492|NCT02574481|OG000|Outcome|ELUVIA Stent Implantation|"Percutaneous stent placement in the SFA/PPA~ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10803716|NCT02462876|BG000|Baseline|VIABAHN® Endoprosthesis|Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
10780493|NCT02574481|OG001|Outcome|Zilver PTX Stent Implantation|"Percutaneous stent placement in the SFA/PPA~Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780494|NCT02574481|OG002|Outcome|Long Lesion Substudy|To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780495|NCT02574481|OG003|Outcome|PK Substudy|To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
10780496|NCT02574481|OG002|Outcome|Long Lesion Substudy|To evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780497|NCT02574481|OG003|Outcome|PK Substudy|To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
10780498|NCT02574481|OG002|Outcome|Long Lesion Substudy|To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780499|NCT02574481|EG000|Reported Event|ELUVIA Stent Implantation|"Percutaneous stent placement in the SFA/PPA~ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780500|NCT02574481|EG001|Reported Event|Zilver PTX Stent Implantation|"Percutaneous stent placement in the SFA/PPA~Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure."
10780501|NCT02574481|EG002|Reported Event|Long Lesion Substudy|To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
10780502|NCT02574481|EG003|Reported Event|PK Substudy|To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
10803717|NCT02462876|FG000|Participant Flow|Viabahn|Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
10803718|NCT02462876|OG000|Outcome|Viabahn|Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
10803719|NCT02462876|EG000|Reported Event|VIABAHN® Endoprosthesis|Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
10803720|NCT02332590|BG000|Baseline|Adalimumab 40 mg/Sarilumab 200 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10803721|NCT02332590|BG001|Baseline|Sarilumab 200 mg/Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10803722|NCT02332590|BG002|Baseline|Total|Total of all reporting groups
10803723|NCT02332590|FG000|Participant Flow|Adalimumab 40 mg/Sarilumab 200 mg|Adalimumab 40 mg subcutaneous (SC) injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (less than [<] 20% improvement from baseline in tender joint count [TJC] and swollen joint count [SJC] for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10803724|NCT02332590|FG001|Participant Flow|Sarilumab 200 mg/Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10803725|NCT02332590|OG000|Outcome|Adalimumab 40 mg/Sarilumab 200 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10850588|NCT00303472|EG001|Reported Event|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10964495|NCT00877877|EG002|Reported Event|Cervarix Group From Month 72 to Month 84|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
10964496|NCT00877877|EG003|Reported Event|Cervarix Group From Month 84 to Month 96|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
10964497|NCT00877877|EG004|Reported Event|Cervarix Group From Month 96 to Month 108|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
10964498|NCT00877877|EG005|Reported Event|Cervarix Group From Month 108 to Month 120|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
10964499|NCT00877890|BG000|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
10964500|NCT00877890|BG001|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
10964501|NCT00877890|BG002|Baseline|Total|Total of all reporting groups
10964502|NCT00877890|FG000|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
10964503|NCT00877890|FG001|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
10964504|NCT00877890|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
10964505|NCT00877890|OG001|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
10964506|NCT00877890|OG000|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
10964507|NCT00877890|OG001|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
10964508|NCT00877890|OG002|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
10964509|NCT00877890|OG003|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
10964510|NCT00877890|EG000|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
10964511|NCT00877890|EG001|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
10964512|NCT00877929|BG000|Baseline|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964513|NCT00877929|BG001|Baseline|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964514|NCT00877929|BG002|Baseline|Total|Total of all reporting groups
10964515|NCT00877929|FG000|Participant Flow|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964516|NCT00877929|FG001|Participant Flow|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964517|NCT00877929|OG000|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964518|NCT00877929|OG001|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964519|NCT00877929|OG000|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
10964520|NCT00877929|OG001|Outcome|Amlodipine 5 mg|
10964521|NCT00877929|OG000|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964522|NCT00877929|OG001|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964523|NCT00877929|EG000|Reported Event|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964524|NCT00877929|EG001|Reported Event|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
10964525|NCT00878072|BG000|Baseline|Famciclovir|Participants received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10964526|NCT00878072|FG000|Participant Flow|Famciclovir|Participants received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10964527|NCT00878072|OG000|Outcome|Famciclovir (Participants Aged 12 to Less Than [<] 15 Years)|Participants aged 12 to <15 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10964528|NCT00878072|OG001|Outcome|Famciclovir (Participants Aged 15 to Less Than [<] 18 Years)|Participants aged 15 to <18 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10964529|NCT00878072|OG000|Outcome|Penciclovir (Participants Aged 12 to Less Than [<] 18 Years)|Participants aged 12 to <18 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets.
10964530|NCT00878072|OG001|Outcome|6-Deoxy Penciclovir (Participants Aged 12 to Less Than [<] 18 Years)|Participants aged 12 to <18 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets.
10801223|NCT01397201|BG001|Baseline|BI 54903 90.9 µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801224|NCT01397201|BG002|Baseline|BI 54903 181.8 µg Bid|2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801225|NCT01397201|BG003|Baseline|Fluticasone Propionate 220µg Bid|2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801226|NCT01397201|BG004|Baseline|Placebo|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801227|NCT01397201|BG005|Baseline|Total|Total of all reporting groups
10801228|NCT01397201|FG000|Participant Flow|Placebo|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801229|NCT01397201|FG001|Participant Flow|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801230|NCT01397201|FG002|Participant Flow|BI 54903 90.9 µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801231|NCT01397201|FG003|Participant Flow|BI 54903 181.8 µg Bid|2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801232|NCT01397201|FG004|Participant Flow|Fluticasone Propionate 220µg Bid|2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801233|NCT01397201|OG000|Outcome|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801234|NCT01397201|OG001|Outcome|BI 54903 90.9 µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801235|NCT01397201|OG002|Outcome|BI 54903 181.8 µg Bid|2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801236|NCT01397201|OG003|Outcome|Fluticasone Propionate 220µg Bid|2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801237|NCT01397201|OG004|Outcome|Placebo|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801238|NCT01397201|EG000|Reported Event|Placebo|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801239|NCT01397201|EG001|Reported Event|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801240|NCT01397201|EG002|Reported Event|BI 54903 90.9 µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801241|NCT01397201|EG003|Reported Event|BI 54903 181.8 µg Bid|2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801242|NCT01397201|EG004|Reported Event|Fluticasone Propionate 220µg Bid|2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801243|NCT01397162|BG000|Baseline|Placebo HFA MDI|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801244|NCT01397162|BG001|Baseline|BI 54903 22.7µg Bid|2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801245|NCT01397162|BG002|Baseline|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
10801246|NCT01397162|BG003|Baseline|BI 54903 90.9µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10780534|NCT02445456|BG000|Baseline|Ex-vivo|"Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780535|NCT02445456|BG001|Baseline|In-vivo|"Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780536|NCT02445456|BG002|Baseline|Total|Total of all reporting groups
10780537|NCT02445456|FG000|Participant Flow|Ex-vivo|"Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780538|NCT02445456|FG001|Participant Flow|In-vivo|"Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780539|NCT02445456|OG000|Outcome|Ex-vivo|"Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780540|NCT02445456|OG001|Outcome|In-vivo|"Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780541|NCT02445456|EG000|Reported Event|Ex-vivo|"Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10780542|NCT02445456|EG001|Reported Event|In-vivo|"Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.~Sienna+ injection: Endoscopic injection of magnetic tracer~MRI scan: MRI scan of pelvis to detect spread of magnetic tracer~Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)~Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)"
10964531|NCT00878072|EG000|Reported Event|Famciclovir (Participants Aged 12 to Less Than [<] 15 Years)|Participants aged 12 to <15 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10780543|NCT02348203|BG000|Baseline|Arm I (Aspirin, Zileuton)|"Patients receive aspirin PO QD and zileuton PO BID for 12 weeks in the absence of unacceptable toxicity.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Zileuton: Given PO"
10780544|NCT02348203|BG001|Baseline|Arm II (Double Placebo)|"Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given aspirin placebo PO~Placebo Administration: Given zileuton placebo PO"
10780545|NCT02348203|BG002|Baseline|Total|Total of all reporting groups
10780546|NCT02348203|FG000|Participant Flow|Arm I (Aspirin, Zileuton)|"Patients receive aspirin PO QD and zileuton PO BID for 12 weeks in the absence of unacceptable toxicity.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Zileuton: Given PO"
10780547|NCT02348203|FG001|Participant Flow|Arm II (Double Placebo)|"Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given aspirin placebo PO~Placebo Administration: Given zileuton placebo PO"
10780548|NCT02348203|OG000|Outcome|Arm I (Aspirin, Zileuton)|"Patients receive aspirin PO QD and zileuton PO BID for 12 weeks in the absence of unacceptable toxicity.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Zileuton: Given PO"
10780549|NCT02348203|OG001|Outcome|Arm II (Double Placebo)|"Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given aspirin placebo PO~Placebo Administration: Given zileuton placebo PO"
10780550|NCT02348203|OG001|Outcome|Arm II (Double Placebo)|Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.
10780551|NCT02348203|EG000|Reported Event|Arm I (Aspirin, Zileuton)|"Patients receive aspirin PO QD and zileuton PO BID for 12 weeks in the absence of unacceptable toxicity.~Aspirin: Given PO~Laboratory Biomarker Analysis: Correlative studies~Zileuton: Given PO"
10780552|NCT02348203|EG001|Reported Event|Arm II (Double Placebo)|"Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given aspirin placebo PO~Placebo Administration: Given zileuton placebo PO"
10964532|NCT00878072|EG001|Reported Event|Famciclovir (Participants Aged 15 to Less Than [<] 18 Years)|Participants aged 15 to <18 years received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
11339759|NCT03637296|BG000|Baseline|Critical Time Intervention|"Individuals who receive intensive care management during and following discharge from the inpatient medical unit.~Critical time intervention: Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care."
10964533|NCT00878072|EG002|Reported Event|Famciclovir|Participants received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
10964534|NCT00878189|BG000|Baseline|PF-03084014 in Solid Tumor Participants|PF-03084014 was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964535|NCT00878189|BG001|Baseline|PF-03084014 in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-ALL/LBL as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964536|NCT00878189|BG002|Baseline|Total|Total of all reporting groups
10964537|NCT00878189|FG000|Participant Flow|PF-03084014 20 mg BID in Solid Tumor Participants|PF-03084014 20 mg was administered orally twice daily (BID), beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of pharmacokinetic (PK) assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964538|NCT00878189|FG001|Participant Flow|PF-03084014 40 mg BID in Solid Tumor Participants|PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964539|NCT00878189|FG002|Participant Flow|PF-03084014 80 mg BID in Solid Tumor Participants|PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964540|NCT00878189|FG003|Participant Flow|PF-03084014 100 mg BID in Solid Tumor Participants|PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964541|NCT00878189|FG004|Participant Flow|PF-03084014 130 mg BID in Solid Tumor Participants|PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964542|NCT00878189|FG005|Participant Flow|PF-03084014 150 mg BID in Solid Tumor Participants|PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10801247|NCT01397162|BG004|Baseline|Fluticasone Propionate 88µg Bid|2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
11379232|NCT03439124|EG001|Reported Event|IV Standard-of-care Cephalosporin|"Ceftriaxone was used as standard-of-care cephalosporin for the treatment of CAP. It is a third-generation cephalosporin with activity against typical bacterial pathogens of CAP requiring hospitalization, and is widely used for the treatment of various bacterial infections in neonates, infants, children, and adults.~Ceftazidime was used as standard-of-care cephalosporin for the treatment of HAP. It is also a third-generation cephalosporin, but with broader activity against Gram-negative aerobic bacilli, including Pseudomonas aeruginosa.~Vancomycin is a glycopeptide antibiotic that is active against staphylococci, including MRSA. At the discretion of the blinded investigator, patients received vancomycin in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
11379233|NCT03369431|BG000|Baseline|Vivomixx, Then Placebo|"This group starts with Vivomixx probiotic for the first 12 weeks then crosses over to have the placebo after a 4-week washout.~Vivomixx: Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.~Placebo: 4.4 grams of maltose and silicon dioxide per sachet"
11379234|NCT03369431|BG001|Baseline|Placebo, Then Vivomixx|"This group starts with the placebo for the first 12 weeks then crosses over to have Vivomixx probiotic after a 4-week washout.~Vivomixx: Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.~Placebo: 4.4 grams of maltose and silicon dioxide per sachet"
11379235|NCT03369431|BG002|Baseline|Total|Total of all reporting groups
11379236|NCT03369431|FG000|Participant Flow|Vivomixx, Then Placebo|"This group starts with Vivomixx probiotic for the first 12 weeks then crosses over to have the placebo after a 4-week washout.~Vivomixx: Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.~Placebo: 4.4 grams of maltose and silicon dioxide per sachet"
11379237|NCT03369431|FG001|Participant Flow|Placebo, Then Vivomixx|"This group starts with the placebo for the first 12 weeks then crosses over to have Vivomixx probiotic after a 4-week washout.~Vivomixx: Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.~Placebo: 4.4 grams of maltose and silicon dioxide per sachet"
11379238|NCT03369431|OG000|Outcome|Vivomixx|Participants who received Vivomixx at an age-group determined dose.
11379239|NCT03369431|OG001|Outcome|Placebo|Participants who received Placebo powder at an age-group determined dose
11379240|NCT03369431|EG000|Reported Event|Vivomixx|Participants who received Vivomixx at an age-group determined dose.
11379241|NCT03369431|EG001|Reported Event|Placebo|Participants who received Placebo powder at an age-group determined dose
10801248|NCT01397162|BG005|Baseline|Total|Total of all reporting groups
10801249|NCT01397162|FG000|Participant Flow|Placebo HFA MDI|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801250|NCT01397162|FG001|Participant Flow|BI 54903 22.7µg Bid|2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801251|NCT01397162|FG002|Participant Flow|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
10801252|NCT01397162|FG003|Participant Flow|BI 54903 90.9µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801253|NCT01397162|FG004|Participant Flow|Fluticasone Propionate 88µg Bid|2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801254|NCT01397162|OG000|Outcome|Placebo HFA MDI|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801255|NCT01397162|OG001|Outcome|BI 54903 22.7µg Bid|2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801256|NCT01397162|OG002|Outcome|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
10801257|NCT01397162|OG003|Outcome|BI 54903 90.9µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801258|NCT01397162|OG004|Outcome|Fluticasone Propionate 88µg Bid|2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801259|NCT01397162|OG000|Outcome|BI 54903 22.7µg Bid|2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801260|NCT01397162|OG001|Outcome|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
10801261|NCT01397162|OG002|Outcome|BI 54903 90.9µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801262|NCT01397162|OG003|Outcome|Fluticasone Propionate 88µg Bid|2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801263|NCT01397162|OG004|Outcome|Placebo HFA MDI|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
10801264|NCT01397162|EG000|Reported Event|Placebo|Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler.)
10801265|NCT01397162|EG001|Reported Event|BI 54903 22.7µg Bid|2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801266|NCT01397162|EG002|Reported Event|BI 54903 45.5µg Bid|2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
10801267|NCT01397162|EG003|Reported Event|BI 54903 90.9µg Bid|2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
10801268|NCT01397162|EG004|Reported Event|Fluticasone Propionate 88µg Bid|2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
10801269|NCT01396278|BG000|Baseline|BI 54903 90.9μg Bid|2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801270|NCT01396278|BG001|Baseline|BI 54903 181.8μg Bid|2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801271|NCT01396278|BG002|Baseline|BI 54903 363.6μg Bid|2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10964543|NCT00878189|FG006|Participant Flow|PF-03084014 220 mg BID in Solid Tumor Participants|PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964544|NCT00878189|FG007|Participant Flow|PF-03084014 330 mg BID in Solid Tumor Participants|PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10780575|NCT01892722|BG000|Baseline|Fingolimod|Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose.
10780576|NCT01892722|BG001|Baseline|Interferon Beta-1a|An intramuscular (IM) injection of Interferon beta-1a was administered once weekly.
10780577|NCT01892722|BG002|Baseline|Total|Total of all reporting groups
10780578|NCT01892722|FG000|Participant Flow|Fingolimod|Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose.
10780579|NCT01892722|FG001|Participant Flow|Interferon Beta-1a|An intramuscular (IM) injection of Interferon beta-1a was administered once weekly.
10780580|NCT01892722|OG000|Outcome|Fingolimod|Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose.
10780581|NCT01892722|OG001|Outcome|Interferon Beta-1a|An intramuscular (IM) injection of Interferon beta-1a was administered once weekly.
10780582|NCT01892722|EG000|Reported Event|Fingolimod|Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose.
10780583|NCT01892722|EG001|Reported Event|Interferon Beta-1a|An intramuscular (IM) injection of Interferon beta-1a was administered once weekly.
11193528|NCT02146131|BG000|Baseline|Standard FB With Fluoroscopy|"Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).~Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions"
10780584|NCT01723774|BG000|Baseline|Arm 1: PIK3CA Wild Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780585|NCT01723774|BG001|Baseline|Arm 2: PIK3CA Mutant Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780586|NCT01723774|BG002|Baseline|Arm 3: Endocrine Resistant Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780587|NCT01723774|BG003|Baseline|Total|Total of all reporting groups
10780588|NCT01723774|FG000|Participant Flow|Arm 1: PIK3CA Wild Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780589|NCT01723774|FG001|Participant Flow|Arm 2: PIK3CA Mutant Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780590|NCT01723774|FG002|Participant Flow|Arm 3: Endocrine Resistant Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780591|NCT01723774|FG003|Participant Flow|Adjuvant Continuation|Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
10780592|NCT01723774|OG000|Outcome|Arm 1: PIK3CA Wild Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780593|NCT01723774|OG001|Outcome|Arm 2: PIK3CA Mutant Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780594|NCT01723774|OG002|Outcome|Arm 3: Endocrine Resistant Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780595|NCT01723774|EG000|Reported Event|Arm 1: PIK3CA Wild Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10801272|NCT01396278|BG003|Baseline|Fluticasone Propionate 88μg Bid|2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801273|NCT01396278|BG004|Baseline|Fluticasone Propionate 440μg Bid|2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801274|NCT01396278|BG005|Baseline|Total|Total of all reporting groups
11339760|NCT03637296|BG001|Baseline|Treatment as Usual|Individuals who receive routine care management during and following discharge from the inpatient medical unit.
11339761|NCT03637296|BG002|Baseline|Total|Total of all reporting groups
11379242|NCT03343054|BG000|Baseline|Dose Escalation: Talazoparib 0.75 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.
11379243|NCT03343054|BG001|Baseline|Dose Escalation: Talazoparib 1.0 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.
11379244|NCT03343054|BG002|Baseline|Dose Expansion: Talazoparib 1.0 mg|Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
11379245|NCT03343054|BG003|Baseline|Total|Total of all reporting groups
11379246|NCT03343054|FG000|Participant Flow|Dose Escalation: Talazoparib 0.75 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day minus (-) 7.
11379247|NCT03343054|FG001|Participant Flow|Dose Escalation: Talazoparib 1.0 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.
11379248|NCT03343054|FG002|Participant Flow|Dose Expansion: Talazoparib 1.0 mg|Participants with Germline breast cancer susceptibility gene mutation (gBRCAm) HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
11379249|NCT03343054|OG000|Outcome|Dose Escalation: Talazoparib 0.75 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.
11379250|NCT03343054|OG001|Outcome|Dose Escalation: Talazoparib 1.0 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.
11379251|NCT03343054|OG000|Outcome|Dose Expansion: Talazoparib 1.0 mg|Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
11379252|NCT03343054|OG002|Outcome|Dose Expansion: Talazoparib 1.0 mg|Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
11379253|NCT03343054|EG000|Reported Event|Dose Escalation: Talazoparib 0.75 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 0.75 mg orally, QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 0.75 mg talazoparib on Day -7.
11379254|NCT03343054|EG001|Reported Event|Dose Escalation: Talazoparib 1.0 mg|Participants with advanced solid tumors who were resistant to standard therapy or for whom no standard therapy was available, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle (except Cycle 1 with 7 additional days lead-in) until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 286 days). Cycle 1 contained a 7 day lead-in phase in which participants received single dose of 1.0 mg talazoparib on Day -7.
11379255|NCT03343054|EG002|Reported Event|Dose Expansion: Talazoparib 1.0 mg|Participants with gBRCAm HER2-negative locally advanced or metastatic breast cancer, received talazoparib capsules at a dose of 1.0 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity or withdrawal of consent (maximum duration: up to 502 days).
11379256|NCT03336866|BG000|Baseline|Placebo|"Normal saline~Placebo: Normal saline"
11379257|NCT03336866|BG001|Baseline|IXT-m200, 6 mg/kg|"Single 6 mg/kg intravenous dose of IXT-m200~IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody"
11379258|NCT03336866|BG002|Baseline|IXT-m200, 20 mg/kg|Single 20 mg/kg intravenous dose of IXT-m200
11379259|NCT03336866|BG003|Baseline|Total|Total of all reporting groups
11379260|NCT03336866|FG000|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline"
11379261|NCT03336866|FG001|Participant Flow|IXT-m200, 6 mg/kg|"Single 6 mg/kg intravenous dose of IXT-m200~IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody"
11379262|NCT03336866|FG002|Participant Flow|IXT-m200, 20 mg/kg|Single IV dose of 20 mg/kg IXT-m200
11379263|NCT03336866|OG000|Outcome|Placebo|Normal Saline
10780596|NCT01723774|EG001|Reported Event|Arm 2: PIK3CA Mutant Type Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780597|NCT01723774|EG002|Reported Event|Arm 3: Endocrine Resistant Cohort|"Tumor biopsy for testing/research at baseline and Cycle 1 Day 15~Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)~Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.~Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned."
10780598|NCT01723774|EG003|Reported Event|Adjuvant Continuation|Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
10780599|NCT01560637|BG000|Baseline|UT-15C|"Open label access~UT-15C (treprostinil diethanolamine): UT-15C sustained release oral tablet for three times daily administration"
10780600|NCT01560637|FG000|Participant Flow|UT-15C|"Open label access~UT-15C (treprostinil diethanolamine): UT-15C sustained release oral tablet for three times daily administration"
10780601|NCT01560637|OG000|Outcome|UT-15C|"Open label access~UT-15C (treprostinil diethanolamine): UT-15C sustained release oral tablet for three times daily administration"
10780602|NCT01560637|EG000|Reported Event|UT-15C|"Open label access~UT-15C (treprostinil diethanolamine): UT-15C sustained release oral tablet for three times daily administration"
10780603|NCT00999804|BG000|Baseline|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780604|NCT00999804|BG001|Baseline|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780605|NCT00999804|BG002|Baseline|Total|Total of all reporting groups
10780606|NCT00999804|FG000|Participant Flow|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
11339762|NCT03637296|FG000|Participant Flow|Critical Time Intervention|"Individuals who receive intensive care management during and following discharge from the inpatient medical unit.~Critical time intervention: Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care."
10780607|NCT00999804|FG001|Participant Flow|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780608|NCT00999804|OG000|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780609|NCT00999804|OG001|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780610|NCT00999804|EG000|Reported Event|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10780611|NCT00999804|EG001|Reported Event|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
10801275|NCT01396278|FG000|Participant Flow|BI 54903 90.9μg Bid|2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10780612|NCT00458003|BG000|Baseline|Phenylephrine|"Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780613|NCT00458003|BG001|Baseline|Ephedrine|"Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780614|NCT00458003|BG002|Baseline|Total|Total of all reporting groups
10780615|NCT00458003|FG000|Participant Flow|Phenylephrine|"Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780616|NCT00458003|FG001|Participant Flow|Ephedrine|"Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780617|NCT00458003|OG000|Outcome|Phenylephrine|"Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780618|NCT00458003|OG001|Outcome|Ephedrine|"Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780619|NCT00458003|EG000|Reported Event|Phenylephrine Mothers|"Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780620|NCT00458003|EG001|Reported Event|Ephedrine Mothers|"Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10801276|NCT01396278|FG001|Participant Flow|BI 54903 181.8μg Bid|2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
11339763|NCT03637296|FG001|Participant Flow|Treatment as Usual|Individuals who receive routine care management during and following discharge from the inpatient medical unit.
11379264|NCT03336866|OG001|Outcome|IXT-m200, 6 mg/kg|Single 6 mg/kg intravenous dose of IXT-m200
10780621|NCT00458003|EG002|Reported Event|Phenylepherine Infants|"Infant of mother who received phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10780622|NCT00458003|EG003|Reported Event|Ephedrine Infants|"Infant of mothers who received an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia~Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery."
10801277|NCT01396278|FG002|Participant Flow|BI 54903 363.6μg Bid|2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801278|NCT01396278|FG003|Participant Flow|Fluticasone Propionate 88μg Bid|2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801279|NCT01396278|FG004|Participant Flow|Fluticasone Propionate 440μg Bid|2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801280|NCT01396278|OG000|Outcome|BI 54903 90.9μg Bid|2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801281|NCT01396278|OG001|Outcome|BI 54903 181.8μg Bid|2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801282|NCT01396278|OG002|Outcome|BI 54903 363.6μg Bid|2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801283|NCT01396278|OG003|Outcome|Fluticasone Propionate 88μg Bid|2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801284|NCT01396278|OG004|Outcome|Fluticasone Propionate 440μg Bid|2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801285|NCT01396278|EG000|Reported Event|BI 54903 90.9μg Bid|2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801286|NCT01396278|EG001|Reported Event|BI 54903 181.8μg Bid|2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801287|NCT01396278|EG002|Reported Event|BI 54903 363.6μg Bid|2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
10801288|NCT01396278|EG003|Reported Event|Fluticasone Propionate 88μg Bid|2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801289|NCT01396278|EG004|Reported Event|Fluticasone Propionate 440μg Bid|2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
10801290|NCT00783367|BG000|Baseline|Cohort 1|Revlimid + rituximab with dexamethasone
10801291|NCT00783367|BG001|Baseline|Cohort 2|Revlimid + rituximab (without dexamethasone)
10801292|NCT00783367|BG002|Baseline|Total|Total of all reporting groups
10801293|NCT00783367|FG000|Participant Flow|Cohort 1|Revlimid + rituximab with dexamethasone
10801294|NCT00783367|FG001|Participant Flow|Cohort 2|Revlimid + rituximab (without dexamethasone)
10801295|NCT00783367|OG000|Outcome|Cohort 1|Revlimid + rituximab with dexamethasone
10801296|NCT00783367|OG001|Outcome|Cohort 2|Revlimid + rituximab (without dexamethasone)
10801297|NCT00783367|EG000|Reported Event|Cohort 1|Revlimid + rituximab with dexamethasone
10801298|NCT00783367|EG001|Reported Event|Cohort 2|Revlimid + rituximab (without dexamethasone)
10801299|NCT00247728|BG000|Baseline|Group A - Untreated Control|untreated control with standard of care, ITT population
10801300|NCT00247728|BG001|Baseline|Group B - 160 mg PI-88/Day|160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population
11379265|NCT03336866|OG002|Outcome|IXT-m200, 20 mg/kg|Single 20 mg/kg intravenous dose of IXT-m200
11379266|NCT03336866|OG000|Outcome|Placebo|Normal saline
11379267|NCT03336866|OG002|Outcome|IXT-m200, 20 mg/kg|Single IV dose of 20 mg/kg IXT-m200
11379268|NCT03336866|OG000|Outcome|IXT-m200, 6 mg/kg|Single 6 mg/kg intravenous dose of IXT-m200
11379269|NCT03336866|OG001|Outcome|IXT-m200, 20 mg/kg|Single 20 mg/kg intravenous dose of IXT-m200
11379270|NCT03336866|EG000|Reported Event|All Subjects: Day 1-3|No Investigational Product administration; subjects were administered 30 mg METH and saline on Day 1 for drug discrimination.
11379271|NCT03336866|EG001|Reported Event|Placebo: Day 4-126|"Normal saline~Placebo: Normal saline"
11379272|NCT03336866|EG002|Reported Event|IXT-m200, 6 mg/kg: Day 4-126|"Single 6 mg/kg intravenous dose of IXT-m200~IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody"
11379273|NCT03336866|EG003|Reported Event|IXT-m200, 20 mg/kg: Day 4-126|Single 20 mg/kg intravenous dose of IXT-m200
11379274|NCT03332173|BG000|Baseline|Zanubrutinib|Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
11379275|NCT03332173|FG000|Participant Flow|Zanubrutinib|Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
11379276|NCT03332173|OG000|Outcome|Zanubrutinib|Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
11379277|NCT03332173|EG000|Reported Event|Zanubrutinib|Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
11379278|NCT03322293|BG000|Baseline|A. Conventional Arm|"This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379279|NCT03322293|BG001|Baseline|B. Combination Arm|"This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379280|NCT03322293|BG002|Baseline|C. Daylight Arm|"This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C)."
11379281|NCT03322293|BG003|Baseline|Total|Total of all reporting groups
11379282|NCT03322293|FG000|Participant Flow|A. Conventional Arm|"This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379283|NCT03322293|FG001|Participant Flow|B. Combination Arm|"This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379284|NCT03322293|FG002|Participant Flow|C. Daylight Arm|"This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C)."
11379285|NCT03322293|OG000|Outcome|A. Conventional Arm|"This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379286|NCT03322293|OG001|Outcome|B. Combination Arm|"This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379287|NCT03322293|OG002|Outcome|C. Daylight Arm|"This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C)."
11379288|NCT03322293|EG000|Reported Event|A. Conventional Arm|"This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379289|NCT03322293|EG001|Reported Event|B. Combination Arm|"This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).~BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not."
11379290|NCT03322293|EG002|Reported Event|C. Daylight Arm|"This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.~Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none~Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C)."
11379291|NCT03315039|BG000|Baseline|Dose Level 1: 100 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379292|NCT03315039|BG001|Baseline|Dose Level 2: 120 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379293|NCT03315039|BG002|Baseline|Total|Total of all reporting groups
11379294|NCT03315039|FG000|Participant Flow|Dose Level 1: 100 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379295|NCT03315039|FG001|Participant Flow|Dose Level 2: 120 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
10780623|NCT03882788|BG000|Baseline|Narcotic Based Anesthesia|Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).
11379296|NCT03315039|OG000|Outcome|Dose Level 1: 100 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379297|NCT03315039|OG001|Outcome|Dose Level 2 : 120 mg/m2/Day Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379298|NCT03315039|OG000|Outcome|Liposomal Annamycin|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379299|NCT03315039|OG000|Outcome|100 mg/m2|Best Overall Response for Participants treated at 100 mg/m2 dose level
11379300|NCT03315039|OG001|Outcome|120 mg/m2|Best Overall Response for treated at 120 mg/m2 dose level
11379301|NCT03315039|EG000|Reported Event|100 mg/m2 Dose Level|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379302|NCT03315039|EG001|Reported Event|120 mg/m2 Dose Level|Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
11379303|NCT03254394|BG000|Baseline|Placebo + FOLFOX|"Intravenous infusion of D5W solution over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Placebo: Dextrose 5% in water will be administered as active comparator.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
10780624|NCT03882788|BG001|Baseline|Volatile Anesthesia|Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
10780625|NCT03882788|BG002|Baseline|Total|Total of all reporting groups
10780626|NCT03882788|FG000|Participant Flow|Narcotic Based Anesthesia|Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).
10780627|NCT03882788|FG001|Participant Flow|Volatile Anesthesia|Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
10780628|NCT03882788|OG000|Outcome|Narcotic Based Anesthesia|Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).
10780629|NCT03882788|OG001|Outcome|Volatile Anesthesia|Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
10780630|NCT03882788|EG000|Reported Event|Narcotic Based Anesthesia|Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).
10780631|NCT03882788|EG001|Reported Event|Volatile Anesthesia|Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
10801301|NCT00247728|BG002|Baseline|Group C - 250 mg PI-88/Day|250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, ITT population
10801302|NCT00247728|BG003|Baseline|Total|Total of all reporting groups
10801303|NCT00247728|FG000|Participant Flow|Group A - Untreated Control|untreated control with standard of care
10801304|NCT00247728|FG001|Participant Flow|Group B - 160 mg PI-88/Day|160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
10801305|NCT00247728|FG002|Participant Flow|Group C - 250 mg PI-88/Day|250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
10801306|NCT00247728|OG000|Outcome|Group A - Untreated Control|untreated control with standard of care
10801307|NCT00247728|OG001|Outcome|Group B - 160 mg PI-88/Day|160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
10801308|NCT00247728|OG002|Outcome|Group C - 250 mg PI-88/Day|250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
10801309|NCT00247728|OG000|Outcome|Group A - Untreated Control|Untreated control with standard of care
10801310|NCT00247728|OG002|Outcome|Group C - 250 mg PI-88/Day|160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week
10801311|NCT00247728|EG000|Reported Event|Group A - Untreated Control|untreated control with standard of care in safety population defined as all randomized subjects, who had at least one assessment following randomization.
10801312|NCT00247728|EG001|Reported Event|Group B - 160 mg PI-88/Day|160 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population (defined as all randomized subjects, who had at least one assessment following randomization)
10801313|NCT00247728|EG002|Reported Event|Group C - 250 mg PI-88/Day|250 mg PI-88 via subcutaneous injection for four consecutive days per week, every week, safety population defined as all randomized subjects, who had at least one assessment following randomization
10801314|NCT00130442|BG000|Baseline|Arm 1- PI-88 Plus Dacarbazine|"PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle~PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion"
10801315|NCT00130442|BG001|Baseline|Arm 2- Dacarbazine Alone|"dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion~dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle"
10801316|NCT00130442|BG002|Baseline|Total|Total of all reporting groups
10801317|NCT00130442|FG000|Participant Flow|Arm 1- PI-88 Plus Dacarbazine|"PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle~PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion"
10801318|NCT00130442|FG001|Participant Flow|Arm 2- Dacarbazine Alone|"dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion~dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle"
10801319|NCT00130442|OG000|Outcome|Arm 1- PI-88 Plus Dacarbazine|"PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle~PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion"
10801320|NCT00130442|OG001|Outcome|Arm 2- Dacarbazine Alone|"dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion~dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle"
10801321|NCT00130442|OG000|Outcome|Arm 1- PI-88 Plus Dacarbazine|PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
10801322|NCT00130442|OG001|Outcome|Arm 2- Dacarbazine Alone|dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
10801323|NCT00130442|EG000|Reported Event|Arm 1- PI-88 Plus Dacarbazine|"PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle~PI-88 and dacarbazine: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion"
10801324|NCT00130442|EG001|Reported Event|Arm 2- Dacarbazine Alone|"dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion~dacarbazine or DTIC: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle"
10803726|NCT02332590|OG001|Outcome|Sarilumab 200 mg/Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
10780632|NCT03834974|BG000|Baseline|Sun Safety Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create sun safety social media messages that will be distributed on our sun safety Twitter and Facebook feeds.~Sun Safety Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about sun safety and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should include a sun safety message (e.g., promoting sunscreen use and protective clothing/hats or discouraging risk behaviors like tanning and burning). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780633|NCT03834974|BG001|Baseline|Digital Health Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create posts that promote the use of technology to engage in healthy lifestyle behaviors (diet, exercise) on our digital health Twitter and Facebook feeds.~Digital Health Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about using technology to get healthy and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should mention some way that technology (e.g., mobile apps, wearables) can be used to promote a healthy habit (e.g., diet, exercise). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780634|NCT03834974|BG002|Baseline|Total|Total of all reporting groups
10780635|NCT03834974|FG000|Participant Flow|Sun Safety Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create sun safety social media messages that will be distributed on our sun safety Twitter and Facebook feeds.~Sun Safety Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about sun safety and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should include a sun safety message (e.g., promoting sunscreen use and protective clothing/hats or discouraging risk behaviors like tanning and burning). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780636|NCT03834974|FG001|Participant Flow|Digital Health Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create posts that promote the use of technology to engage in healthy lifestyle behaviors (diet, exercise) on our digital health Twitter and Facebook feeds.~Digital Health Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about using technology to get healthy and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should mention some way that technology (e.g., mobile apps, wearables) can be used to promote a healthy habit (e.g., diet, exercise). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780637|NCT03834974|OG000|Outcome|Prospective Participants|All prospective participants
10780638|NCT03834974|OG000|Outcome|Sun Safety Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create sun safety social media messages that will be distributed on our sun safety Twitter and Facebook feeds.~Sun Safety Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about sun safety and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should include a sun safety message (e.g., promoting sunscreen use and protective clothing/hats or discouraging risk behaviors like tanning and burning). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780639|NCT03834974|OG001|Outcome|Digital Health Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create posts that promote the use of technology to engage in healthy lifestyle behaviors (diet, exercise) on our digital health Twitter and Facebook feeds.~Digital Health Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about using technology to get healthy and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should mention some way that technology (e.g., mobile apps, wearables) can be used to promote a healthy habit (e.g., diet, exercise). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10801325|NCT04539262|BG000|Baseline|RDV, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801326|NCT04539262|BG001|Baseline|RDV + Placebo, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801327|NCT04539262|BG002|Baseline|Placebo, Part A|Participants received placebo to match inhaled RDV in Part A daily for 5 days.
10780640|NCT03834974|EG000|Reported Event|Sun Safety Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create sun safety social media messages that will be distributed on our sun safety Twitter and Facebook feeds.~Sun Safety Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about sun safety and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should include a sun safety message (e.g., promoting sunscreen use and protective clothing/hats or discouraging risk behaviors like tanning and burning). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10780641|NCT03834974|EG001|Reported Event|Digital Health Social Media Challenge|"During this 4-week intervention, participants will be incentivized to create posts that promote the use of technology to engage in healthy lifestyle behaviors (diet, exercise) on our digital health Twitter and Facebook feeds.~Digital Health Social Media Challenge: Participants will attend a webinar to learn how to create effective social media posts about using technology to get healthy and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should mention some way that technology (e.g., mobile apps, wearables) can be used to promote a healthy habit (e.g., diet, exercise). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card."
10801328|NCT04539262|BG003|Baseline|RDV, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801329|NCT04539262|BG004|Baseline|RDV + Placebo, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801330|NCT04539262|BG005|Baseline|Placebo, Part B|Participants received placebo to match inhaled RDV in Part B daily for 5 days.
10801331|NCT04539262|BG006|Baseline|RDV, Part C|Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
10801332|NCT04539262|BG007|Baseline|Placebo, Part C|Participants received placebo to match inhaled RDV in Part C daily for 5 days.
10801333|NCT04539262|BG008|Baseline|Total|Total of all reporting groups
10801334|NCT04539262|FG000|Participant Flow|Remdesivir (RDV), Part A|Participants received inhaled remdesivir (RDV) 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801335|NCT04539262|FG001|Participant Flow|RDV + Placebo, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801336|NCT04539262|FG002|Participant Flow|Placebo, Part A|Participants received placebo to match inhaled RDV in Part A daily for 5 days.
10801337|NCT04539262|FG003|Participant Flow|RDV, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801338|NCT04539262|FG004|Participant Flow|RDV + Placebo, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801339|NCT04539262|FG005|Participant Flow|Placebo, Part B|Participants received placebo to match inhaled RDV in Part B daily for 5 days.
10801340|NCT04539262|FG006|Participant Flow|RDV, Part C|Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
10801341|NCT04539262|FG007|Participant Flow|Placebo, Part C|Participants received placebo to match inhaled RDV in Part C daily for 5 days.
10801342|NCT04539262|OG000|Outcome|RDV, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801343|NCT04539262|OG001|Outcome|RDV + Placebo, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801344|NCT04539262|OG002|Outcome|Placebo, Part A|Participants received placebo to match inhaled RDV in Part A daily for 5 days.
10801345|NCT04539262|OG003|Outcome|RDV, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801346|NCT04539262|OG004|Outcome|RDV + Placebo, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801347|NCT04539262|OG005|Outcome|Placebo, Part B|Participants received placebo to match inhaled RDV in Part B daily for 5 days.
10801348|NCT04539262|OG006|Outcome|RDV, Part C|Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
10801349|NCT04539262|OG007|Outcome|Placebo, Part C|Participants received placebo to match inhaled RDV in Part C daily for 5 days.
10801350|NCT04539262|OG003|Outcome|RDV, Part B|Participants received inhaled RDV 62 mg administered as an aerosolized solution by inhalation through facemask daily for 5 days.
10801351|NCT04539262|OG000|Outcome|RDV, Part C|Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
10801352|NCT04539262|OG001|Outcome|Placebo, Part C|Participants received placebo to match inhaled RDV in Part C daily for 5 days.
10801353|NCT04539262|EG000|Reported Event|RDV, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801354|NCT04539262|EG001|Reported Event|RDV + Placebo, Part A|Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
10801355|NCT04539262|EG002|Reported Event|Placebo, Part A|Participants received placebo to match inhaled RDV in Part A daily for 5 days.
10780642|NCT03821675|BG000|Baseline|Active|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780643|NCT03821675|BG001|Baseline|Sham|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780644|NCT03821675|BG002|Baseline|Total|Total of all reporting groups
10780645|NCT03821675|FG000|Participant Flow|Active|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780646|NCT03821675|FG001|Participant Flow|Sham|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780647|NCT03821675|OG000|Outcome|Active|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780648|NCT03821675|OG001|Outcome|Sham|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
10780649|NCT03821675|OG000|Outcome|Active|Subjects will receive an active electrical stimulation device to wear for 1 hour
10780650|NCT03821675|OG001|Outcome|Sham|Subjects did not receive sham device for this outcome measure.
10780651|NCT03821675|EG000|Reported Event|Active|intervention
10780652|NCT03821675|EG001|Reported Event|Sham|control
10780653|NCT03794544|BG000|Baseline|Durvalumab 1500 mg|Participants received durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780654|NCT03794544|BG001|Baseline|Durvalumab 1500 mg + Oleclumab 3000 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780655|NCT03794544|BG002|Baseline|Durvalumab 1500 mg + Monalizumab 750 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780656|NCT03794544|BG003|Baseline|Durvalumab 1500 mg + Danvatirsen 200 mg|Participants received danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780657|NCT03794544|BG004|Baseline|Total|Total of all reporting groups
10780658|NCT03794544|FG000|Participant Flow|Durvalumab 1500 mg|Participants received durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780659|NCT03794544|FG001|Participant Flow|Durvalumab 1500 mg + Oleclumab 3000 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780660|NCT03794544|FG002|Participant Flow|Durvalumab 1500 mg + Monalizumab 750 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780661|NCT03794544|FG003|Participant Flow|Durvalumab 1500 mg + Danvatirsen 200 mg|Participants received danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780662|NCT03794544|OG000|Outcome|Durvalumab 1500 mg|Participants received durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780663|NCT03794544|OG001|Outcome|Durvalumab 1500 mg + Oleclumab 3000 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780664|NCT03794544|OG002|Outcome|Durvalumab 1500 mg + Monalizumab 750 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
11339764|NCT03637296|OG000|Outcome|Critical Time Intervention|"Individuals who receive intensive care management during and following discharge from the inpatient medical unit.~Critical time intervention: Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care."
10801356|NCT04539262|EG003|Reported Event|RDV, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
10801357|NCT04539262|EG004|Reported Event|RDV + Placebo, Part B|Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
11339765|NCT03637296|OG001|Outcome|Treatment as Usual|Individuals who receive routine care management during and following discharge from the inpatient medical unit.
11339766|NCT03637296|EG000|Reported Event|Critical Time Intervention|"Individuals who receive intensive care management during and following discharge from the inpatient medical unit.~Critical time intervention: Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care."
11339767|NCT03637296|EG001|Reported Event|Treatment as Usual|Individuals who receive routine care management during and following discharge from the inpatient medical unit.
11339768|NCT03637348|BG000|Baseline|TrueTear|"Use of TrueTear device to stimulate tear production~TrueTear: Ues of TrueTear neurostimulator"
11339769|NCT03637348|FG000|Participant Flow|TrueTear|"Use of TrueTear device to stimulate tear production~TrueTear: Use of TrueTear neurostimulator"
11339770|NCT03637348|OG000|Outcome|TrueTear|"Use of TrueTear device to stimulate tear production~TrueTear: Ues of TrueTear neurostimulator"
11339771|NCT03637348|OG000|Outcome|TrueTear|"Use of TrueTear device to stimulate tear production~TrueTear: Use of TrueTear neurostimulator"
11339772|NCT03637348|EG000|Reported Event|TrueTear|"Use of TrueTear device to stimulate tear production~TrueTear: Ues of TrueTear neurostimulator"
11339773|NCT03637517|BG000|Baseline|DSM265 25% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base~DSM265 25% SDD, 400 mg fasted: Reference formulation used in early clinical trials."
11339774|NCT03637517|BG001|Baseline|DSM265-TPGS 34% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fasted: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state."
11339775|NCT03637517|BG002|Baseline|DSM265-TPGS 34% SDD, 400 mg Fed|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fed: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state."
11339776|NCT03637517|BG003|Baseline|Total|Total of all reporting groups
11339777|NCT03637517|FG000|Participant Flow|DSM265 25% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base~DSM265 25% SDD, 400 mg fasted: Reference formulation used in early clinical trials."
11339778|NCT03637517|FG001|Participant Flow|DSM265-TPGS 34% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fasted: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state."
11339779|NCT03637517|FG002|Participant Flow|DSM265-TPGS 34% SDD, 400 mg Fed|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fed: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state."
11339780|NCT03637517|OG000|Outcome|DSM265 25% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base~DSM265 25% SDD, 400 mg fasted: Reference formulation used in early clinical trials."
11339781|NCT03637517|OG001|Outcome|DSM265-TPGS 34% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fasted: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state."
11339782|NCT03637517|OG002|Outcome|DSM265-TPGS 34% SDD, 400 mg Fed|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fed: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state."
11339783|NCT03637517|EG000|Reported Event|DSM265 25% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base~DSM265 25% SDD, 400 mg fasted: Reference formulation used in early clinical trials."
11339784|NCT03637517|EG001|Reported Event|DSM265-TPGS 34% SDD, 400 mg Fasted|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fasted: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state."
11339785|NCT03637517|EG002|Reported Event|DSM265-TPGS 34% SDD, 400 mg Fed|"Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)~DSM265-TPGS 34% SDD, 400 mg fed: New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state."
11339786|NCT03637699|BG000|Baseline|Intervention|"Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.~Positive Psychology: 5-week positive psychology intervention"
11339787|NCT03637699|BG001|Baseline|Waitlist Control|"Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.~Positive Psychology: 5-week positive psychology intervention"
11339788|NCT03637699|BG002|Baseline|Total|Total of all reporting groups
10780665|NCT03794544|OG003|Outcome|Durvalumab 1500 mg + Danvatirsen 200 mg|Participants received danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780666|NCT03794544|EG000|Reported Event|Durvalumab 1500 mg|Participants received durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780667|NCT03794544|EG001|Reported Event|Durvalumab 1500 mg + Oleclumab 3000 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780668|NCT03794544|EG002|Reported Event|Durvalumab 1500 mg + Monalizumab 750 mg|Participants received durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10780669|NCT03794544|EG003|Reported Event|Durvalumab 1500 mg + Danvatirsen 200 mg|Participants received danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection was planned between Day 29 and Day 42. After surgical resection, participants were followed up to Day 105 (starting from Week 1 Day 1).
10801358|NCT04539262|EG005|Reported Event|Placebo, Part B|Participants received placebo to match inhaled RDV in Part B daily for 5 days.
10801359|NCT04539262|EG006|Reported Event|RDV, Part C|Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
10801360|NCT04539262|EG007|Reported Event|Placebo, Part C|Participants received placebo to match inhaled RDV in Part C daily for 5 days.
11339789|NCT03637699|FG000|Participant Flow|Intervention|"Subjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.~Positive Psychology: 5-week positive psychology intervention"
10801361|NCT04482439|BG000|Baseline|Vivity Monovision Group|Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
10801362|NCT04482439|FG000|Participant Flow|Vivity Monovision Group|Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
10801363|NCT04482439|OG000|Outcome|Vivity Monovision Group|Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
10801364|NCT04482439|OG000|Outcome|Vivity Mini-monovision|"Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.~Vivity Extended Depth of Focus intraocular lens (IOL): Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye."
10801365|NCT04482439|EG000|Reported Event|Vivity Monovision Group|Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
10801366|NCT04465162|BG000|Baseline|Treatment (Radiation Therapy)|"Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.~Radiation Therapy: Undergo radiation therapy"
10801367|NCT04465162|FG000|Participant Flow|Treatment (Radiation Therapy)|"Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.~Radiation Therapy: Undergo radiation therapy"
10801368|NCT04465162|OG000|Outcome|Treatment (Radiation Therapy)|"Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.~Radiation Therapy: Undergo radiation therapy"
10801369|NCT04465162|EG000|Reported Event|Treatment (Radiation Therapy)|"Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.~Radiation Therapy: Undergo radiation therapy"
10801370|NCT04404725|BG000|Baseline|Overall Study|"Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants.~Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns."
11339790|NCT03637699|FG001|Participant Flow|Waitlist Control|"Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.~Positive Psychology: 5-week positive psychology intervention"
10801371|NCT04404725|FG000|Participant Flow|Comfilcon A Then Samfilcon A|"Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.~comfilcon A: Subjects will be randomized to wear comfilcon A for one month.~Samfilcon A: Subjects will be randomized to wear samfilcon A for one month."
10801372|NCT04404725|FG001|Participant Flow|Samfilcon A Then Comfilcon A|"Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.~comfilcon A: Subjects will be randomized to wear comfilcon A for one month.~Samfilcon A: Subjects will be randomized to wear samfilcon A for one month."
10801373|NCT04404725|OG000|Outcome|Comfilcon A|Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.
10801374|NCT04404725|OG001|Outcome|Samfilcon A|Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
10801375|NCT04404725|EG000|Reported Event|Comfilcon A|Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.
10801376|NCT04404725|EG001|Reported Event|Samfilcon A|Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.
10780670|NCT03732807|BG000|Baseline|Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .
10780671|NCT03732807|BG001|Baseline|Ritlecitinib (PF-06651600) 200 mg Then 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780672|NCT03732807|BG002|Baseline|Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780673|NCT03732807|BG003|Baseline|Ritlecitinib (PF-06651600) 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780674|NCT03732807|BG004|Baseline|Ritlecitinib (PF-06651600) 10 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780675|NCT03732807|BG005|Baseline|Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780676|NCT03732807|BG006|Baseline|Placebo, Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780677|NCT03732807|BG007|Baseline|Total|Total of all reporting groups
10780678|NCT03732807|FG000|Participant Flow|Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .
10780679|NCT03732807|FG001|Participant Flow|Ritlecitinib (PF-06651600) 200 mg Then 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780680|NCT03732807|FG002|Participant Flow|Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780681|NCT03732807|FG003|Participant Flow|Ritlecitinib (PF-06651600) 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780682|NCT03732807|FG004|Participant Flow|Ritlecitinib (PF-06651600) 10 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10801377|NCT04382586|BG000|Baseline|Zanubrutinib + Supportive Care|Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801378|NCT04382586|BG001|Baseline|Placebo + Supportive Care|Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
11193529|NCT02146131|BG001|Baseline|R-EBUS With Ultrathin Bronchoscope|"Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.~Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.~R-EBUS with ultrathin bronchoscope: Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions"
11193530|NCT02146131|BG002|Baseline|Total|Total of all reporting groups
10780683|NCT03732807|FG005|Participant Flow|Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780684|NCT03732807|FG006|Participant Flow|Placebo, Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780685|NCT03732807|OG000|Outcome|Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .
10780686|NCT03732807|OG001|Outcome|Ritlecitinib (PF-06651600) 200 mg Then 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780687|NCT03732807|OG002|Outcome|Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780688|NCT03732807|OG003|Outcome|Ritlecitinib (PF-06651600) 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780689|NCT03732807|OG004|Outcome|Ritlecitinib (PF-06651600) 10 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780690|NCT03732807|OG005|Outcome|Placebo|Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780691|NCT03732807|OG005|Outcome|Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780692|NCT03732807|OG006|Outcome|Placebo, Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
11339791|NCT03637699|OG000|Outcome|Intervention|"Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.~Positive Psychology: 5-week positive psychology intervention"
10780693|NCT03732807|EG000|Reported Event|Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .
10780694|NCT03732807|EG001|Reported Event|Ritlecitinib (PF-06651600) 200 mg Then 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780695|NCT03732807|EG002|Reported Event|Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
11339792|NCT03637699|OG001|Outcome|Waitlist Control|"Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.~Positive Psychology: 5-week positive psychology intervention"
11379304|NCT03254394|BG001|Baseline|Lidocaine + FOLFOX|"Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379305|NCT03254394|BG002|Baseline|Total|Total of all reporting groups
11379306|NCT03254394|FG000|Participant Flow|Placebo + FOLFOX|"Intravenous infusion of D5W solution over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Placebo: Dextrose 5% in water will be administered as active comparator.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379307|NCT03254394|FG001|Participant Flow|Lidocaine + FOLFOX|"Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379308|NCT03254394|OG000|Outcome|Placebo + FOLFOX|"Intravenous infusion of D5W solution over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Placebo: Dextrose 5% in water will be administered as active comparator.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379309|NCT03254394|OG001|Outcome|Lidocaine + FOLFOX|"Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379310|NCT03254394|EG000|Reported Event|Placebo + FOLFOX|"Intravenous infusion of D5W solution over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Placebo: Dextrose 5% in water will be administered as active comparator.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379311|NCT03254394|EG001|Reported Event|Lidocaine + FOLFOX|"Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.~FOLFOX:~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.~Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.~FOLFOX regimen: Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
11379312|NCT03253809|BG000|Baseline|Coronary Sinus Branch Pacing|"After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.~ECG signals will be saved digitally for analysis~Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced."
11379313|NCT03253809|FG000|Participant Flow|Coronary Sinus Branch Pacing|"After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.~ECG signals will be saved digitally for analysis~Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced."
11379314|NCT03253809|OG000|Outcome|Coronary Sinus Branch Pacing|"After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.~ECG signals will be saved digitally for analysis~Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced."
10801379|NCT04382586|BG002|Baseline|Total|Total of all reporting groups
10780696|NCT03732807|EG003|Reported Event|Ritlecitinib (PF-06651600) 30 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780697|NCT03732807|EG004|Reported Event|Ritlecitinib (PF-06651600) 10 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780698|NCT03732807|EG005|Reported Event|Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10780699|NCT03732807|EG006|Reported Event|Placebo, Ritlecitinib (PF-06651600) 50 mg|Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
10801380|NCT04382586|FG000|Participant Flow|Zanubrutinib + Supportive Care|Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801381|NCT04382586|FG001|Participant Flow|Placebo + Supportive Care|Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801382|NCT04382586|OG000|Outcome|Zanubrutinib + Supportive Care|Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801383|NCT04382586|OG001|Outcome|Placebo + Supportive Care|Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801384|NCT04382586|EG000|Reported Event|Zanubrutinib + Supportive Care|Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801385|NCT04382586|EG001|Reported Event|Placebo + Supportive Care|Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
10801386|NCT04348656|BG000|Baseline|Convalescent Plasma|"~500 mL ABO compatible convalescent apheresis plasma~Convalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."
10801387|NCT04348656|BG001|Baseline|Standard of Care|Treated as per institutional standard of care.
10801388|NCT04348656|BG002|Baseline|Total|Total of all reporting groups
10801389|NCT04348656|FG000|Participant Flow|Convalescent Plasma|"~500 mL ABO compatible convalescent apheresis plasma~Convalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."
10801390|NCT04348656|FG001|Participant Flow|Standard of Care|Treated as per institutional standard of care.
10801391|NCT04348656|OG000|Outcome|Convalescent Plasma|"~500 mL ABO compatible convalescent apheresis plasma~Convalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."
10801392|NCT04348656|OG001|Outcome|Standard of Care|Treated as per institutional standard of care.
10801393|NCT04348656|EG000|Reported Event|Convalescent Plasma|"~500 mL ABO compatible convalescent apheresis plasma~Convalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."
10801394|NCT04348656|EG001|Reported Event|Standard of Care|Treated as per institutional standard of care.
10803727|NCT02332590|OG000|Outcome|Sarilumab 200 mg/Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
11379315|NCT03253809|EG000|Reported Event|Coronary Sinus Branch Pacing|"After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.~ECG signals will be saved digitally for analysis~Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced."
11379316|NCT03180294|BG000|Baseline|Bupropion 150 mg|One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
11379317|NCT03180294|BG001|Baseline|Bupropion 300 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL PO in a.m. daily for 1 week (titration off)
11379318|NCT03180294|BG002|Baseline|Placebo|One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
11379319|NCT03180294|BG003|Baseline|Total|Total of all reporting groups
11379320|NCT03180294|FG000|Participant Flow|Bupropion 150 mg|One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
11379321|NCT03180294|FG001|Participant Flow|Bupropion 300 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
11379322|NCT03180294|FG002|Participant Flow|Placebo|One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
11379323|NCT03180294|OG000|Outcome|Bupropion 150 mg|One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
11379324|NCT03180294|OG001|Outcome|Bupropion 300 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
11379325|NCT03180294|OG002|Outcome|Placebo|One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
11379326|NCT03180294|OG000|Outcome|Bupropion 150 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
11379327|NCT03180294|EG000|Reported Event|Bupropion 150 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
11379328|NCT03180294|EG001|Reported Event|Bupropion 300 mg|One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
11379329|NCT03180294|EG002|Reported Event|Placebo|One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
11379330|NCT03151408|BG000|Baseline|Pracinostat Plus AZA|"60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Pracinostat: 60 mg capsule~Azacitidine: SC or IV injection"
11379331|NCT03151408|BG001|Baseline|Placebo Plus AZA|"1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Placebos: capsule~Azacitidine: SC or IV injection"
11379332|NCT03151408|BG002|Baseline|Total|Total of all reporting groups
11379333|NCT03151408|FG000|Participant Flow|Pracinostat Plus AZA|"60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Pracinostat: 60 mg capsule~Azacitidine: SC or IV injection"
11379334|NCT03151408|FG001|Participant Flow|Placebo Plus AZA|"1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Placebos: capsule~Azacitidine: SC or IV injection"
10780700|NCT03731364|BG000|Baseline|CA-008 5 mg (0.05 mg/mL) Cohort 1|Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008
10780701|NCT03731364|BG001|Baseline|Placebo - Cohort 1|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
11379335|NCT03151408|OG000|Outcome|Pracinostat Plus AZA|"60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Pracinostat: 60 mg capsule~Azacitidine: SC or IV injection"
11379336|NCT03151408|OG001|Outcome|Placebo Plus AZA|"1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Placebos: capsule~Azacitidine: SC or IV injection"
11379337|NCT03151408|EG000|Reported Event|Pracinostat Plus AZA|"60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Pracinostat: 60 mg capsule~Azacitidine: SC or IV injection"
11379338|NCT03151408|EG001|Reported Event|Placebo Plus AZA|"1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.~Placebos: capsule~Azacitidine: SC or IV injection"
11379339|NCT03137173|BG000|Baseline|Ceftobiprole Medocaril|Patients treated with ceftobiprole medocaril 500 mg every 8 hours (with dose adjustment for renal impairment). Duration of infusion: 2 hours.
11379340|NCT03137173|BG001|Baseline|Vancomycin+Aztreonam|Vancomycin 1000 mg (or 15 mg/kg) every 12 hours plus aztreonam 1000 mg every 12 hours (both with dose adjustment for renal impairment). Vancomycin dose adjustment for obese and hypermetabolic patients was according to local standard of care. The requirement for aztreonam therapy was to be reassessed at the 72-hour study visit. Duration of vancomycin infusion: 2 hours; duration of aztreonam infusion: 0.5 hours.
11379341|NCT03137173|BG002|Baseline|Total|Total of all reporting groups
11379342|NCT03137173|FG000|Participant Flow|Ceftobiprole Medocaril|Patients treated with ceftobiprole medocaril 500 mg every 8 hours (with dose adjustment for renal impairment).
11379343|NCT03137173|FG001|Participant Flow|Vancomycin+Aztreonam|Patients treated with vancomycin 1000 mg (or 15 mg/kg) every 12 hours plus aztreonam 1000 mg every 12 hours (both with dose adjustment for renal impairment). Vancomycin dose adjustment for obese and hypermetabolic patients was according to local standard of care. The requirement for aztreonam therapy was to be reassessed at the 72-hour study visit.
11379344|NCT03137173|OG000|Outcome|Ceftobiprole Medocaril|Patients treated with ceftobiprole medocaril 500 mg every 8 hours (with dose adjustment for renal impairment). Duration of infusion: 2 hours.
11379345|NCT03137173|OG001|Outcome|Vancomycin+Aztreonam|Vancomycin 1000 mg (or 15 mg/kg) every 12 hours plus aztreonam 1000 mg every 12 hours (both with dose adjustment for renal impairment). Vancomycin dose adjustment for obese and hypermetabolic patients was according to local standard of care. The requirement for aztreonam therapy was to be reassessed at the 72-hour study visit. Duration of vancomycin infusion: 2 hours; duration of aztreonam infusion: 0.5 hours.
11379346|NCT03137173|OG000|Outcome|Ceftobiprole Medocaril|Patients treated with ceftobiprole medocaril 500 mg every 8 Hours (with dose adjustment for renal impairment). Duration of infusion: 2 hours.
11379347|NCT03137173|EG000|Reported Event|Ceftobiprole Medocaril|"Patients treated with ceftobiprole medocaril 500 mg every 8 hours (with dose adjustment for renal impairment).~Ceftobiprole medocaril: A reconstituted solution of 500 mg of ceftobiprole in 250 mL of water for injection was administered IV every 8 hours (with dose adjustment for renal impairment) for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor. Duration of each infusion: 2 hours."
11379348|NCT03137173|EG001|Reported Event|Vancomycin+Aztreonam|"Patients treated with vancomycin 1000 mg (or 15 mg/kg) every 12 hours plus aztreonam 1000 mg every 12 hours (both with dose adjustment for renal impairment).~Vancomycin+aztreonam: vancomycin 1000 mg (or 15 mg/kg) every 12 hours (with dose adjustment for renal impairment). Vancomycin dose adjustment for obese and hypermetabolic patients was according to local standard of care. Duration of infusion: 2 hours.~Aztreonam for Injection for IV infusion must have been reconstituted with at least 3 mL sterile water for injection. The reconstituted solution of aztreonam must have been further diluted with 100 mL NaCl 0.9% solution for injection, resulting in an aztreonam concentration of 10 mg/mL (1%). Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen might have been adjusted. The requirement for aztreonam therapy was to be reassessed at the 72-hour study visit."
11379349|NCT03111030|BG000|Baseline|ProacTive SCI|"Individualized physical activity coaching sessions~ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:~An assessment of motivated the participant is to be physically active~A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.~B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.~Progress and barriers will be reassessed and discussed."
11379350|NCT03111030|BG001|Baseline|Wait-list Control|Standard care, receiving physical activity coaching sessions after completing post-testing
11379351|NCT03111030|BG002|Baseline|Total|Total of all reporting groups
11379352|NCT03111030|FG000|Participant Flow|ProacTive SCI|"Individualized physical activity coaching sessions~ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:~An assessment of motivated the participant is to be physically active~A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.~B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.~Progress and barriers will be reassessed and discussed."
11379353|NCT03111030|FG001|Participant Flow|Wait-list Control|Standard care, receiving physical activity coaching sessions after completing post-testing
10780702|NCT03731364|BG002|Baseline|CA-008 10 mg (0.1 mg/mL) Cohort 2|Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008
10780703|NCT03731364|BG003|Baseline|CA-008 15 mg (0.15 mg/mL) Cohort 3|Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008
10780704|NCT03731364|BG004|Baseline|Placebo - Cohorts 2 and 3|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780705|NCT03731364|BG005|Baseline|Total|Total of all reporting groups
10780706|NCT03731364|FG000|Participant Flow|CA-008 5 mg (0.05 mg/mL) Cohort 1|Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008
11379354|NCT03111030|OG000|Outcome|ProacTive SCI|"Individualized physical activity coaching sessions~ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:~An assessment of motivated the participant is to be physically active~A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.~B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.~Progress and barriers will be reassessed and discussed."
11379355|NCT03111030|OG001|Outcome|Wait-list Control|Standard care, receiving physical activity coaching sessions after completing post-testing
11379356|NCT03111030|EG000|Reported Event|ProacTive SCI|"Individualized physical activity coaching sessions~ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:~An assessment of motivated the participant is to be physically active~A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.~B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.~Progress and barriers will be reassessed and discussed."
11379357|NCT03111030|EG001|Reported Event|Wait-list Control|Standard care, receiving physical activity coaching sessions after completing post-testing
11379358|NCT03081052|BG000|Baseline|Lung Transplant With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379359|NCT03081052|BG001|Baseline|Lung Transplant With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379360|NCT03081052|BG002|Baseline|Heart Transplant & LVAD Implantation With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379361|NCT03081052|BG003|Baseline|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379362|NCT03081052|BG004|Baseline|Total|Total of all reporting groups
11379363|NCT03081052|FG000|Participant Flow|Lung Transplant With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379364|NCT03081052|FG001|Participant Flow|Lung Transplant With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379365|NCT03081052|FG002|Participant Flow|Heart Transplant & LVAD Implantation With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379366|NCT03081052|FG003|Participant Flow|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379367|NCT03081052|OG000|Outcome|Lung Transplant With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379368|NCT03081052|OG001|Outcome|Lung Transplant With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379369|NCT03081052|OG000|Outcome|Heart Transplant & LVAD Implantation With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379370|NCT03081052|OG001|Outcome|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379371|NCT03081052|OG002|Outcome|Heart Transplant & LVAD Implantation With iNO|iNO: Subjects will receive inhaled Nitric Oxide in this intervention
11379372|NCT03081052|OG003|Outcome|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
11379373|NCT03081052|OG002|Outcome|Heart Transplant & LVAD Implantation With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379374|NCT03081052|OG003|Outcome|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379375|NCT03081052|EG000|Reported Event|Lung Transplant With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379376|NCT03081052|EG001|Reported Event|Lung Transplant With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
11379377|NCT03081052|EG002|Reported Event|Heart Transplant & LVAD Implantation With iNO|iNO: Subject will receive inhaled Nitric Oxide in this intervention
11379378|NCT03081052|EG003|Reported Event|Heart Transplant & LVAD Implantation With iEPO|iEPO: Subject will receive inhaled Epoprostrenol in this intervention
10780707|NCT03731364|FG001|Participant Flow|Placebo - Cohort 1|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780708|NCT03731364|FG002|Participant Flow|CA-008 10 mg (0.1 mg/mL) Cohort 2|Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008
10780709|NCT03731364|FG003|Participant Flow|CA-008 15 mg (0.15 mg/mL) Cohort 3|Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008
10780710|NCT03731364|FG004|Participant Flow|Placebo - Cohorts 2 and 3|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780711|NCT03731364|OG000|Outcome|CA-008 5 mg (0.05 mg/mL) Cohort 1|Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008
10780712|NCT03731364|OG001|Outcome|Placebo - Cohort 1|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780713|NCT03731364|OG002|Outcome|CA-008 10 mg (0.1 mg/mL) Cohort 2|Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008
10780714|NCT03731364|OG003|Outcome|CA-008 15 mg (0.15 mg/mL) Cohort 3|Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008
10780715|NCT03731364|OG004|Outcome|Placebo - Cohorts 2 and 3|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780716|NCT03731364|EG000|Reported Event|CA-008 5 mg (0.05 mg/mL) Cohort 1|Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008
10780717|NCT03731364|EG001|Reported Event|Placebo - Cohort 1|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10780718|NCT03731364|EG002|Reported Event|CA-008 10 mg (0.1 mg/mL) Cohort 2|Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008
10780719|NCT03731364|EG003|Reported Event|CA-008 15 mg (0.15 mg/mL) Cohort 3|Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008
10780720|NCT03731364|EG004|Reported Event|Placebo - Cohorts 2 and 3|Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active
10801395|NCT04283253|BG000|Baseline|Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
10801396|NCT04283253|FG000|Participant Flow|Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
11339793|NCT03637699|OG001|Outcome|Waitlist Control|"Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study~Positive Psychology: 5-week positive psychology intervention"
10801397|NCT04283253|OG000|Outcome|Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
10801398|NCT04283253|EG000|Reported Event|Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
10801399|NCT04246541|BG000|Baseline|Control|"Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery~Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery."
10801400|NCT04246541|BG001|Baseline|Ketorolac|"Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.~Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac."
10801401|NCT04246541|BG002|Baseline|Total|Total of all reporting groups
10801402|NCT04246541|FG000|Participant Flow|Control|"Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery~Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery."
10801403|NCT04246541|FG001|Participant Flow|Ketorolac|"Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.~Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac."
10801404|NCT04246541|OG000|Outcome|Control|"Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery~Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery."
10780721|NCT03728153|BG000|Baseline|20mg Dose|"Fluoxetine 20 MG Oral Tablet~Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days"
11193531|NCT02146131|FG000|Participant Flow|Standard FB With Fluoroscopy|"Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).~Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions"
11379379|NCT03028740|BG000|Baseline|Placebo|Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
11379380|NCT03028740|BG001|Baseline|Cenicriviroc 150 mg|Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
11379381|NCT03028740|BG002|Baseline|Total|Total of all reporting groups
11379382|NCT03028740|FG000|Participant Flow|Placebo|Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
11379383|NCT03028740|FG001|Participant Flow|Cenicriviroc 150 mg|Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
11379384|NCT03028740|OG000|Outcome|Placebo|Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
11379385|NCT03028740|OG001|Outcome|Cenicriviroc 150 mg|Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
11379386|NCT03028740|OG001|Outcome|Cenicriviroc 150 mg|Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
11379387|NCT03028740|OG000|Outcome|Drug: Placebo|Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
11379388|NCT03028740|OG001|Outcome|Drug: Cenicriviroc 150 mg|Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
11379389|NCT03028740|EG000|Reported Event|Placebo|Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
11379390|NCT03028740|EG001|Reported Event|Cenicriviroc 150 mg|Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
11379391|NCT03015142|BG000|Baseline|New Image-guidance Software|Patients who had spine surgery with new image-guidance software
11379392|NCT03015142|FG000|Participant Flow|New Image-guidance Software|Patients who had spine surgery with new image-guidance software.
11379393|NCT03015142|OG000|Outcome|New Image-guidance Software|Patients who had spine surgery with new image-guidance software
11379394|NCT03015142|OG000|Outcome|New Image-guidance Software|Patients who had spine surgery with new image-guidance software.
11379395|NCT03015142|OG000|Outcome|New Image-guidance Software|Patients who had spine surgery
11379396|NCT03015142|EG000|Reported Event|New Image-guidance Software|Patients who had spine surgery with new image-guidance software
10780722|NCT03728153|FG000|Participant Flow|20mg Dose|"Fluoxetine 20 MG Oral Tablet~Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days"
10780723|NCT03728153|OG000|Outcome|20mg Dose|"Fluoxetine 20 MG Oral Tablet~Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days"
10780724|NCT03728153|EG000|Reported Event|20mg Dose|"Fluoxetine 20 MG Oral Tablet~Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days"
11379397|NCT03012672|BG000|Baseline|ARM I (HIGHER-DOSE)|"ARM I (HIGHER-DOSE):~INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC) on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11379398|NCT03012672|BG001|Baseline|ARM II (LOWER-DOSE)|"ARM II (LOWER-DOSE):~INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11379399|NCT03012672|BG002|Baseline|Total|Total of all reporting groups
11379400|NCT03012672|FG000|Participant Flow|Arm I (Higher-dose)|"INDUCTION: Patients receive G-CSF SC on days 0-5, higher dose cladribine IV over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve CR/CRi with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11379401|NCT03012672|FG001|Participant Flow|Arm II (Lower-dose)|"INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve CR/CRi with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11379402|NCT03012672|OG000|Outcome|All Patients Enrolled|Total number of patients enrolled
10780725|NCT03724422|BG000|Baseline|Control|This group will receive the standard of care treatment for their distal humerus fracture only.
10780726|NCT03724422|BG001|Baseline|Intervention|"This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.~Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively"
10780727|NCT03724422|BG002|Baseline|Total|Total of all reporting groups
10780728|NCT03724422|FG000|Participant Flow|Control|This group will receive the standard of care treatment for their distal humerus fracture only.
10780729|NCT03724422|FG001|Participant Flow|Intervention|"This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.~Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively"
10780730|NCT03724422|OG000|Outcome|Control|This group will receive the standard of care treatment for their distal humerus fracture only.
10780731|NCT03724422|OG001|Outcome|Intervention|"This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.~Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively"
10780732|NCT03724422|EG000|Reported Event|Control|This group will receive the standard of care treatment for their distal humerus fracture only.
10780733|NCT03724422|EG001|Reported Event|Intervention|"This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.~Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively"
11339794|NCT03637699|EG000|Reported Event|Intervention|"Subjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.~Positive Psychology: 5-week positive psychology intervention"
10801405|NCT04246541|OG001|Outcome|Ketorolac|"Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.~Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac."
10801406|NCT04246541|EG000|Reported Event|Control|"Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery~Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery."
10801407|NCT04246541|EG001|Reported Event|Ketorolac|"Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.~Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac."
10803728|NCT02332590|EG000|Reported Event|DB Period - Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during DB period. The dosing frequency of adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
10803729|NCT02332590|EG001|Reported Event|DB Period - Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
10803730|NCT02332590|EG002|Reported Event|OLE Period - Sarilumab 200 mg|All participants who completed 24 weeks DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to maximum of additional 276 weeks (i.e. up to Week 300).
10803731|NCT02255656|BG000|Baseline|Alemtuzumab|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10803732|NCT02255656|FG000|Participant Flow|Alemtuzumab|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10803733|NCT02255656|OG000|Outcome|Delayed Alemtuzumab Treatment (DAT)|Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10803734|NCT02255656|OG001|Outcome|Initial Alemtuzumab Treatment (IAT)|Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10803735|NCT02255656|OG002|Outcome|Alemtuzumab|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10780734|NCT03720899|BG000|Baseline|NicoBloc|"NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.~NicoBloc: For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions."
10780735|NCT03720899|BG001|Baseline|Nicotine Lozenge|"Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.~Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs."
10780736|NCT03720899|BG002|Baseline|Total|Total of all reporting groups
10780737|NCT03720899|FG000|Participant Flow|NicoBloc|"NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.~NicoBloc: For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions."
10780738|NCT03720899|FG001|Participant Flow|Nicotine Lozenge|"Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.~Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs."
10780739|NCT03720899|OG000|Outcome|NicoBloc|"NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.~NicoBloc: For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions."
11193532|NCT02146131|FG001|Participant Flow|R-EBUS With Ultrathin Bronchoscope|"Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.~Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.~R-EBUS with ultrathin bronchoscope: Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions"
11193533|NCT02146131|OG000|Outcome|Standard FB With Fluoroscopy|"Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).~Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions"
11193534|NCT02146131|OG001|Outcome|R-EBUS With Ultrathin Bronchoscope|"Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.~Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.~R-EBUS with ultrathin bronchoscope: Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions"
11193535|NCT02146131|EG000|Reported Event|Standard FB With Fluoroscopy|"Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).~Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions"
11339795|NCT03637699|EG001|Reported Event|Waitlist Control|"Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.~Positive Psychology: 5-week positive psychology intervention"
10850589|NCT00303472|EG002|Reported Event|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
11339796|NCT03637842|BG000|Baseline|Lorcaserin XR|"Lorcaserin XR 20mg daily~Lorcaserin: Lorcaserin XR 20mg per day"
11339797|NCT03637842|BG001|Baseline|Placebo|"Placebo Oral Capsule~Placebo oral capsule: Placebo"
10780740|NCT03720899|OG001|Outcome|Nicotine Lozenge|"Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.~Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs."
10780741|NCT03720899|EG000|Reported Event|NicoBloc|"NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.~NicoBloc: For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions."
10780742|NCT03720899|EG001|Reported Event|Nicotine Lozenge|"Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.~Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs."
10801408|NCT04079881|BG000|Baseline|A (Pre-prandial Insulin Administration) / (Post-prandial Insulin Administration)|"Visit 1: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. Visit 2: will give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801409|NCT04079881|BG001|Baseline|B (Post-prandial Insulin Administration) / (Pre-prandial Insulin Administration)|"Visit 1: will give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal; Visit 2: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801410|NCT04079881|BG002|Baseline|Total|Total of all reporting groups
10801411|NCT04079881|FG000|Participant Flow|A (Pre-prandial Insulin Administration) : B (Post-prandial Insulin Administration)|"Visit 1: will receive short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. Visit 2: will receive short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801412|NCT04079881|FG001|Participant Flow|B: (Post-prandial Insulin Administration): A (Pre-prandial Insulin Administration)|Visit 1: will receive short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal Visit 2: will receive short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
10801413|NCT04079881|OG000|Outcome|Pre-prandial Insulin Administration|"Pre-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801414|NCT04079881|OG001|Outcome|Post-prandial Insulin Administration|"Post-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801415|NCT04079881|OG001|Outcome|Post-prandial Insulin Administration:|"Post-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
11193536|NCT02146131|EG001|Reported Event|R-EBUS With Ultrathin Bronchoscope|"Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.~Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.~R-EBUS with ultrathin bronchoscope: Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions"
10801416|NCT04079881|EG000|Reported Event|Pre-prandial Insulin|"Will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
10801417|NCT04079881|EG001|Reported Event|Post-prandial Insulin|"Will give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal.~Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia."
11339798|NCT03637842|BG002|Baseline|Total|Total of all reporting groups
10780743|NCT03716869|BG000|Baseline|Targeted Screening Arm (Current Process)|Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.
10780744|NCT03716869|BG001|Baseline|Universal Screening Arm (Intervention)|"Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores >10 are considered a positive screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.~Universal Screening Arm: Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.~SAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.~Treatment engagement will be tracked per current SAP processes.~To immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.~Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral."
10780745|NCT03716869|BG002|Baseline|Total|Total of all reporting groups
10780746|NCT03716869|FG000|Participant Flow|Targeted Screening Arm (Current Process)|Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.
10780747|NCT03716869|FG001|Participant Flow|Universal Screening Arm (Intervention)|"Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores >10 are considered a positive screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.~Universal Screening Arm: Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.~SAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.~Treatment engagement will be tracked per current SAP processes.~To immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.~Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral."
10780748|NCT03716869|OG000|Outcome|Targeted Screening Arm (Current Process)|Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.
10780749|NCT03716869|OG001|Outcome|Universal Screening Arm (Intervention)|"Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores >10 are considered a positive screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.~Universal Screening Arm: Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.~SAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.~Treatment engagement will be tracked per current SAP processes.~To immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.~Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral."
10780750|NCT03716869|EG000|Reported Event|Targeted Screening Arm (Current Process)|Students randomized to the targeted screening arm will complete their routine school-based health screenings. Students will be followed through the academic year for referrals to the Student Assistance Program (SAP). SAP currently exists in all Pennsylvania (PA) schools and functions like a triage service. If a student exhibits behavior concerning for MDD (raised by any contact, e.g. teachers, nurse, parent, peer, or even self-referral), SAP will triage the student and based on the initial assessment provide recommendations for school or community-based services.
10801418|NCT03950674|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10801419|NCT03950674|BG001|Baseline|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10801420|NCT03950674|BG002|Baseline|Total|Total of all reporting groups
11339799|NCT03637842|FG000|Participant Flow|Lorcaserin XR|"Lorcaserin XR 20mg daily~Lorcaserin: Lorcaserin XR 20mg per day"
10780751|NCT03716869|EG001|Reported Event|Universal Screening Arm (Intervention)|"Students randomized to the universal screening arm will complete the Patient Health Questionnaire (PHQ-9) during the academic year. This screening tool includes nine close-ended questions with a scoring system ranging from 0 to 27. Scores >10 are considered a positive screen. Students with a positive PHQ-9 result will then proceed to SAP triage as per the current process for those referred via the targeted screening arm.~Universal Screening Arm: Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.~SAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.~Treatment engagement will be tracked per current SAP processes.~To immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.~Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral."
10801421|NCT03950674|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10801422|NCT03950674|FG001|Participant Flow|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10801423|NCT03950674|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10801424|NCT03950674|OG001|Outcome|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10801425|NCT03950674|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10801426|NCT03950674|EG001|Reported Event|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10801427|NCT03950674|EG002|Reported Event|Placebo Switched to Pembrolizumab Monotherapy|Participants originally randomized to the placebo arm that experienced disease progression were given pembrolizumab 200 mg IV on Day 1 Q3W after the study was unblinded.
10801428|NCT03868839|BG000|Baseline|Telmisartan Pill|"Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.~Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks."
10801429|NCT03868839|FG000|Participant Flow|Telmisartan Pill|"Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.~Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks."
10801430|NCT03868839|OG000|Outcome|Telmisartan Pill|"Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.~Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks."
10801431|NCT03868839|EG000|Reported Event|Telmisartan Pill|"Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.~Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks."
10801432|NCT03847974|BG000|Baseline|LIB003|"LIB003~LIB003: 300 mg SC Q4W"
10801433|NCT03847974|FG000|Participant Flow|LIB003 (Lerodalcibep)|"LIB003 (lerodalcibep)~LIB003: 300 mg SC Q4W"
10801434|NCT03847974|OG000|Outcome|LIB003 (Lerodalcibep)|"LIB003 (lerodalcibep)~LIB003: 300 mg SC Q4W"
10801435|NCT03847974|EG000|Reported Event|LIB003 (Lerodalcibep)|"LIB003 (lerodalcibep)~LIB003: 300 mg SC Q4W"
10801440|NCT03787095|BG000|Baseline|Cohort 1: Cemiplimab|"Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Cemiplimab: Administered as an intravenous (IV) infusion"
11339800|NCT03637842|FG001|Participant Flow|Placebo|"Placebo Oral Capsule~Placebo oral capsule: Placebo"
10780752|NCT03713957|BG000|Baseline|GRF6021|"Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.~GRF6021: GRF6021 for IV infusion"
10780753|NCT03713957|BG001|Baseline|Placebo|"Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.~Placebo: Placebo for IV infusion"
10780754|NCT03713957|BG002|Baseline|Total|Total of all reporting groups
10780755|NCT03713957|FG000|Participant Flow|GRF6021|"Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.~GRF6021: GRF6021 for IV infusion"
10780756|NCT03713957|FG001|Participant Flow|Placebo|"Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.~Placebo: Placebo for IV infusion"
10780757|NCT03713957|OG000|Outcome|GRF6021|"Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.~GRF6021: GRF6021 for IV infusion"
10780758|NCT03713957|OG001|Outcome|Placebo|"Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.~Placebo: Placebo for IV infusion"
10780759|NCT03713957|EG000|Reported Event|GRF6021|"Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.~GRF6021: GRF6021 for IV infusion"
10780760|NCT03713957|EG001|Reported Event|Placebo|"Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.~Placebo: Placebo for IV infusion"
10780761|NCT04598152|BG000|Baseline|Both Arms Reported Together.|"Because only 1 participant entered in the real followed by sham condition, we report baseline variables combined across the arms. All 4 participants received active tDCS.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously."
11193537|NCT02146248|BG000|Baseline|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
10780762|NCT04598152|FG000|Participant Flow|Sham Transcranial Direct Current Stimulation (tDCS) During fMRI Followed by Active tDCS During fMRI|"Each subject will first undergo sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive active tDCS during the task in the scanner.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously."
10780763|NCT04598152|FG001|Participant Flow|ActiveTranscranial Direct Current Stimulation (tDCS) During fMRI Followed by Sham tDCS During fMRI|Each subject will first undergo active transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive sham tDCS during the task in the scanner.
10780764|NCT04598152|OG000|Outcome|Active vs Sham Transcranial Direct Current Stimulation During fMRI|"Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.~This is a within subjects design. Each participant received both active and sham treatment in a randomized crossover design. The outcome of interest is the within-person difference in BOLD response between the active and sham tDCS administrations. As such, only one arm is reported."
10780765|NCT04598152|OG000|Outcome|Active vs Sham Transcranial Direct Current Stimulation During fMRI|"Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.~This is a within subjects design. Each participant received both active and sham treatment in a randomized crossover design. The outcome of interest is the number of individuals who reported a side-effect during the active tDCS stimulation but not the sham tDCS stimulation. As such, only one arm is reported."
10801441|NCT03787095|BG001|Baseline|Cohort 1: Placebo|"Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Placebo: Diluent for REGN2810 , administered as an IV infusion"
10801442|NCT03787095|BG002|Baseline|Total|Total of all reporting groups
11339801|NCT03637842|OG000|Outcome|Lorcaserin XR|"Lorcaserin XR 20mg daily~Lorcaserin: Lorcaserin XR 20mg per day"
10801443|NCT03787095|FG000|Participant Flow|Cohort 1: Cemiplimab|"Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Cemiplimab: Administered as an intravenous (IV) infusion"
10801444|NCT03787095|FG001|Participant Flow|Cohort 1: Placebo|"Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Placebo: Diluent for REGN2810 , administered as an IV infusion"
11339802|NCT03637842|OG001|Outcome|Placebo|"Placebo Oral Capsule~Placebo oral capsule: Placebo"
10780766|NCT04598152|EG000|Reported Event|Active Transcranial Direct Current Stimulation During fMRI|"Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.~This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one arm is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes."
10780767|NCT04598152|EG001|Reported Event|Sham Transcranial Direct Current Stimulation During fMRI|"Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner.~TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.~This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one arm is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes."
10780768|NCT04353271|BG000|Baseline|Treatment|"Subjects in this arm will receive the study drug~Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days."
10780769|NCT04353271|BG001|Baseline|Control|"Subjects in this arm will take placebo for 6 days~Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days."
10780770|NCT04353271|BG002|Baseline|Total|Total of all reporting groups
10780771|NCT04353271|FG000|Participant Flow|Treatment|"Subjects in this arm will receive the study drug~Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days."
10780772|NCT04353271|FG001|Participant Flow|Control|"Subjects in this arm will take placebo for 6 days~Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days."
10780773|NCT04353271|OG000|Outcome|Treatment|"Subjects in this arm will receive the study drug~Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days."
10780774|NCT04353271|OG001|Outcome|Control|"Subjects in this arm will take placebo for 6 days~Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days."
10780775|NCT04353271|EG000|Reported Event|Treatment|"Subjects in this arm will receive the study drug~Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days."
10780776|NCT04353271|EG001|Reported Event|Control|"Subjects in this arm will take placebo for 6 days~Placebo: Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days."
10801445|NCT03787095|OG000|Outcome|Cohort 1: Cemiplimab|"Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Cemiplimab: Administered as an intravenous (IV) infusion"
10801446|NCT03787095|OG001|Outcome|Cohort 1: Placebo|"Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Placebo: Diluent for REGN2810 , administered as an IV infusion"
10801447|NCT03787095|OG001|Outcome|Cohort 1: Placebo|"Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen. Placebo: Diluent for REGN2810 , administered as an IV infusion"
10801448|NCT03787095|EG000|Reported Event|Cohort 1: Cemiplimab|"Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Cemiplimab: Administered as an intravenous (IV) infusion"
10801449|NCT03787095|EG001|Reported Event|Cohort 1: Placebo|"Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.~Participants continued their current non-study provided ART regimen.~Placebo: Diluent for REGN2810 , administered as an IV infusion"
10803736|NCT02255656|OG000|Outcome|Delayed Alemtuzumab Treatment (DAT)|Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10803737|NCT02255656|OG002|Outcome|Alemtuzumab|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], and CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10780777|NCT05166824|BG000|Baseline|Surgical- Abdominoplasty|"Subjects enrolled in the surgical arm were treated with the device being placed in contact with the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.~TempSure: Radiofrequency platform~Scalpel: Cold knife~Bovie: Electrosurgery and electrocautery platform"
10780778|NCT05166824|BG001|Baseline|Women's Health|"Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.~TempSure: Radiofrequency platform"
10780779|NCT05166824|BG002|Baseline|Skin Rejuvenation|"The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.~TempSure: Radiofrequency platform~Pelleve: Radiofrequency platform"
10780780|NCT05166824|BG003|Baseline|Surgical- Blepharoplasty|"Subjects enrolled in the surgical arm were treated with the device being placed in contact with the eye area The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.~TempSure: Radiofrequency platform~Scalpel: Cold knife~Bovie: Electrosurgery and electrocautery platform"
10780781|NCT05166824|BG004|Baseline|Total|Total of all reporting groups
10780782|NCT05166824|FG000|Participant Flow|Surgical- Abdominoplasty|Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.
10780783|NCT05166824|FG001|Participant Flow|Women's Health|Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
10780784|NCT05166824|FG002|Participant Flow|Skin Rejuvenation|The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.
10780785|NCT05166824|FG003|Participant Flow|Surgical- Blepharoplasty|Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.
10780786|NCT05166824|OG000|Outcome|Women's Health|"Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.~TempSure: Radiofrequency platform"
10780787|NCT05166824|OG001|Outcome|Skin Rejuvenation|"The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.~TempSure: Radiofrequency platform~Pelleve: Radiofrequency platform"
10780788|NCT05166824|OG002|Outcome|Surgical- Blepharoplasty|Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.
10780789|NCT05166824|OG000|Outcome|Surgical- Abdominoplasty|"Subjects enrolled in the surgical arm were treated with the device being placed in contact with the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.~TempSure: Radiofrequency platform~Scalpel: Cold knife~Bovie: Electrosurgery and electrocautery platform"
10780790|NCT05166824|EG000|Reported Event|Surgical- Abdominoplasty|"Subjects enrolled in the surgical arm were treated with the device being placed in contact with the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.~TempSure: Radiofrequency platform~Scalpel: Cold knife~Bovie: Electrosurgery and electrocautery platform"
10780791|NCT05166824|EG001|Reported Event|Women's Health|"Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.~TempSure: Radiofrequency platform"
10780792|NCT05166824|EG002|Reported Event|Skin Rejuvenation|"The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.~TempSure: Radiofrequency platform~Pelleve: Radiofrequency platform"
10780793|NCT05166824|EG003|Reported Event|Surgical- Blepharoplasty|"Subjects enrolled in the surgical arm were treated with the device being placed in contact with the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.~TempSure: Radiofrequency platform~Scalpel: Cold knife~Bovie: Electrosurgery and electrocautery platform"
10780794|NCT04570670|BG000|Baseline|Randomization Sequence AB|"Treatment A: A single oral dose of BLS-11 190 mg (2 x 95 mg) MMF~Treatment B: A single oral dose of Tecfidera® 240 mg (1 × 240 mg) DMF"
10780795|NCT04570670|BG001|Baseline|Randomization Sequence BA|"Treatment B: A single oral dose of Tecfidera® 240 mg (1 × 240 mg) DMF~Treatment A: A single oral dose of BLS-11 190 mg (2 x 95 mg) MMF"
10780796|NCT04570670|BG002|Baseline|Total|Total of all reporting groups
10780797|NCT04570670|FG000|Participant Flow|First Randomization Treatment Sequence AB|"Treatment A: A single oral dose of BLS-11 190 mg (2 x 95 mg)~Treatment B: A single oral dose of Tecfidera® 240 mg (1 × 240 mg)"
10780798|NCT04570670|FG001|Participant Flow|First Randomization Treatment Sequence BA|"Treatment B: A single oral dose of Tecfidera® 240 mg (1 × 240 mg)~Treatment A: A single oral dose of BLS-11 190 mg (2 x 95 mg)"
10780799|NCT04570670|OG000|Outcome|Test (BLS-11)|"A single oral dose administration of BLS-11 190 mg (2 × 95 mg monomethyl fumarate delayed-release capsules) at Hour 0 on Day 1~monomethyl fumarate 190 mg"
10780800|NCT04570670|OG001|Outcome|Reference (Tecfidera)|"A single oral dose administration of Tecfidera 240 mg (1 × 240 mg dimethyl fumarate delayed-release capsule) at Hour 0 on Day 1~dimethyl fumarate 240 mg"
10780801|NCT04570670|EG000|Reported Event|Test (BLS-11)|"A single oral dose administration of BLS-11 190 mg (2 × 95 mg monomethyl fumarate delayed-release capsules) at Hour 0 on Day 1~monomethyl fumarate 190 mg"
10780802|NCT04570670|EG001|Reported Event|Reference (Tecfidera)|"A single oral dose administration of Tecfidera 240 mg (1 × 240 mg dimethyl fumarate delayed-release capsule) at Hour 0 on Day 1~dimethyl fumarate 240 mg"
10780803|NCT04552704|BG000|Baseline|Phase I (CD24Fc)|"Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.~CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV"
10780804|NCT04552704|BG001|Baseline|Phase II, Arm I (CD24Fc)|"Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.~CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV"
10780805|NCT04552704|BG002|Baseline|Phase II, Arm II (Placebo)|"Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.~Placebo Administration: Given IV"
10780806|NCT04552704|BG003|Baseline|Total|Total of all reporting groups
10780807|NCT04552704|FG000|Participant Flow|Phase I|Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
10780808|NCT04552704|OG000|Outcome|Phase I|Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
10780809|NCT04552704|OG000|Outcome|Phase II|"Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.~CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV"
10780810|NCT04552704|EG000|Reported Event|Phase I|Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
10780811|NCT04546581|BG000|Baseline|Intervention Group|"Participants in this group will receive the investigational product and standard of care (SOC).~Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780812|NCT04546581|BG001|Baseline|Control Group|"Participants in this group will receive a placebo and standard of care (SOC).~Placebo: Participants will receive a single infusion of the placebo (saline).~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780813|NCT04546581|BG002|Baseline|Total|Total of all reporting groups
10780814|NCT04546581|FG000|Participant Flow|Intervention Group|"Participants in this group will receive the investigational product and standard of care (SOC).~Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780815|NCT04546581|FG001|Participant Flow|Control Group|"Participants in this group will receive a placebo and standard of care (SOC).~Placebo: Participants will receive a single infusion of the placebo (saline).~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780816|NCT04546581|OG000|Outcome|Intervention Group|"Participants in this group will receive the investigational product and standard of care (SOC).~Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780817|NCT04546581|OG001|Outcome|Control Group|"Participants in this group will receive a placebo and standard of care (SOC).~Placebo: Participants will receive a single infusion of the placebo (saline).~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780818|NCT04546581|EG000|Reported Event|Intervention Group|"Participants in this group will receive the investigational product and standard of care (SOC).~Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780819|NCT04546581|EG001|Reported Event|Control Group|"Participants in this group will receive a placebo and standard of care (SOC).~Placebo: Participants will receive a single infusion of the placebo (saline).~Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC)."
10780820|NCT04236245|BG000|Baseline|Venclose RF System|"Treatment of great saphenous vein (GSV) using Venclose RF System~Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System"
11339803|NCT03637842|EG000|Reported Event|Lorcaserin XR|"Lorcaserin XR 20mg daily~Lorcaserin: Lorcaserin XR 20mg per day"
10780821|NCT04236245|FG000|Participant Flow|Venclose RF System|"Treatment of great saphenous vein (GSV) using Venclose RF System~Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System"
10780822|NCT04236245|OG000|Outcome|Venclose RF System|"Treatment of great saphenous vein (GSV) using Venclose RF System~Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System"
10780823|NCT04236245|EG000|Reported Event|Venclose RF System|"Treatment of great saphenous vein (GSV) using Venclose RF System~Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System"
10780824|NCT03915626|BG000|Baseline|Rivastigmine RLD and Generic Patches|Session 1: RLD patch worn for 9 hours, then at least one week wash out period, Session 2: Generic patch worn for 9 hours, then at least one week wash out period, Session 3: RLD patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min), then at least one week wash out period Session 4: Generic patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min)
10780825|NCT03915626|FG000|Participant Flow|Rivastigmine RLD and Generic Patches|Session 1: RLD patch worn for 9 hours, then at least one week wash out period, Session 2: Generic patch worn for 9 hours, then at least one week wash out period, Session 3: RLD patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min), then at least one week wash out period Session 4: Generic patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min)
10780826|NCT03915626|OG000|Outcome|RLD Patch|"RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours~Rivastigmine (RLD) transdermal patch: brand name patch"
10780827|NCT03915626|OG001|Outcome|Generic Patch|"generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours~Rivastigmine (generic) transdermal patch: generic patch"
10780828|NCT03915626|OG002|Outcome|RLD Patch With Heat|"RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application~Rivastigmine (RLD) transdermal patch: brand name patch"
11339804|NCT03637842|EG001|Reported Event|Placebo|"Placebo Oral Capsule~Placebo oral capsule: Placebo"
10780829|NCT03915626|OG003|Outcome|Generic Patch With Heat|"generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application~Rivastigmine (generic) transdermal patch: generic patch"
10780830|NCT03915626|EG000|Reported Event|RLD Patch|"RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours~Rivastigmine (RLD) transdermal patch: brand name patch"
10780831|NCT03915626|EG001|Reported Event|Generic Patch|"generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours~Rivastigmine (generic) transdermal patch: generic patch"
10780832|NCT03915626|EG002|Reported Event|RLD Patch With Heat|"RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application~Rivastigmine (RLD) transdermal patch: brand name patch"
10780833|NCT03915626|EG003|Reported Event|Generic Patch With Heat|"generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application~Rivastigmine (generic) transdermal patch: generic patch"
10801450|NCT03746951|BG000|Baseline|Fascia Iliaca Compartment Block (FICB)|"FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801451|NCT03746951|BG001|Baseline|Lumbar Plexus Block (LPB)|"LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801452|NCT03746951|BG002|Baseline|Total|Total of all reporting groups
10801453|NCT03746951|FG000|Participant Flow|Fascia Iliaca Compartment Block (FICB)|"FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801454|NCT03746951|FG001|Participant Flow|Lumbar Plexus Block (LPB)|"LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801455|NCT03746951|OG000|Outcome|Fascia Iliaca Compartment Block (FICB)|"FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801456|NCT03746951|OG001|Outcome|Lumbar Plexus Block (LPB)|"LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801457|NCT03746951|EG000|Reported Event|Fascia Iliaca Compartment Block (FICB)|"FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801458|NCT03746951|EG001|Reported Event|Lumbar Plexus Block (LPB)|"LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.~Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block"
10801459|NCT03685747|BG000|Baseline|Vancomycin|"A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.~Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose."
10801460|NCT03685747|FG000|Participant Flow|Vancomycin|"A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.~Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose."
10801461|NCT03685747|OG000|Outcome|Vancomycin|"A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.~Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose."
10801462|NCT03685747|EG000|Reported Event|Vancomycin|"A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.~Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose."
10801463|NCT03671148|BG000|Baseline|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801464|NCT03671148|BG001|Baseline|Risankizumab|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801465|NCT03671148|BG002|Baseline|Total|Total of all reporting groups
10801466|NCT03671148|FG000|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801467|NCT03671148|FG001|Participant Flow|Risankizumab|Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801468|NCT03671148|OG000|Outcome|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801469|NCT03671148|OG001|Outcome|Risankizumab|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801470|NCT03671148|EG000|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801471|NCT03671148|EG001|Reported Event|Risankizumab 150 mg|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10801472|NCT03640949|BG000|Baseline|Vasopressin and Methylprednisolone|"The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).~Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU)~Methylprednisolone: 40 mg methylprednisolone once"
10801473|NCT03640949|BG001|Baseline|Placebo|"The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl (normal saline) from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.~NaCl: Placebo"
10780834|NCT03698279|BG000|Baseline|Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780835|NCT03698279|BG001|Baseline|Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780836|NCT03698279|BG002|Baseline|Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780837|NCT03698279|BG003|Baseline|Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)|Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780838|NCT03698279|BG004|Baseline|Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780839|NCT03698279|BG005|Baseline|Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780840|NCT03698279|BG006|Baseline|Total|Total of all reporting groups
10780841|NCT03698279|FG000|Participant Flow|Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 30 microgram (μg) high-dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780842|NCT03698279|FG001|Participant Flow|Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780843|NCT03698279|FG002|Participant Flow|Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780844|NCT03698279|FG003|Participant Flow|Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)|Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780845|NCT03698279|FG004|Participant Flow|Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to less than [<] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780846|NCT03698279|FG005|Participant Flow|Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted trivalent influenza vaccine (TIV), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780847|NCT03698279|OG000|Outcome|Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780848|NCT03698279|OG001|Outcome|Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780849|NCT03698279|OG002|Outcome|Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780850|NCT03698279|OG003|Outcome|Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)|Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780851|NCT03698279|OG004|Outcome|Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780852|NCT03698279|OG005|Outcome|Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
11339805|NCT03638323|BG000|Baseline|Normal Hearing|"Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of less than 14 are in the normal hearing group"
10780853|NCT03698279|OG003|Outcome|Group 4a: QIV-SD, 15 μg, (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 30 μg.
10780854|NCT03698279|OG004|Outcome|Group 4b: QIV-SD, 15 μg, (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 45 μg.
10780855|NCT03698279|OG005|Outcome|Group 4c: QIV-SD, 15 μg, (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 60 μg.
10801474|NCT03640949|BG002|Baseline|Total|Total of all reporting groups
11339806|NCT03638323|BG001|Baseline|Risk of Presbycusis|"Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of 14 or more are in the risk of presbycusis group"
11339807|NCT03638323|BG002|Baseline|Total|Total of all reporting groups
11339808|NCT03638323|FG000|Participant Flow|LOOP Group|"Speech therapy consultation for patients with Alzheimer's disease~Speech therapy: During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire"
11339809|NCT03638323|OG000|Outcome|Normal Hearing|"Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of less than 14 are in the normal hearing group"
11339810|NCT03638323|OG001|Outcome|Risk of Presbycusis|"Participants were divided into two groups based on their score on the Hearing Questionnaire. Patients with a score of 14 or more are in the risk of presbycusis group"
11339811|NCT03638323|OG000|Outcome|No Word Alteration|"Patients with a score of 40 or more at the BIMM questionnaire are in the no word alteration group"
11339812|NCT03638323|OG001|Outcome|Lack of Word|"Patients with a score of less than 40 at the BIMM questionnaire are in the lack of word group"
11339813|NCT03638323|EG000|Reported Event|LOOP Group|"Speech therapy consultation for patients with Alzheimer's disease~Speech therapy: During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire"
11339814|NCT03638622|BG000|Baseline|Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)|Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
11339815|NCT03638622|FG000|Participant Flow|Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)|Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
11339816|NCT03638622|OG000|Outcome|Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)|Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
11339817|NCT03638622|EG000|Reported Event|Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)|Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
11339818|NCT03638635|BG000|Baseline|Standard Bupivacaine|"Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine: Abdominal injection of bupivacaine into fascial layer."
11339819|NCT03638635|BG001|Baseline|Bupivacaine Liposome|"Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer."
11339820|NCT03638635|BG002|Baseline|Total|Total of all reporting groups
11339821|NCT03638635|FG000|Participant Flow|Standard Bupivacaine|"Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine: Abdominal injection of bupivacaine into fascial layer."
11339822|NCT03638635|FG001|Participant Flow|Bupivacaine Liposome|"Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer."
11339823|NCT03638635|OG000|Outcome|Standard Bupivacaine|"Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine: Abdominal injection of bupivacaine into fascial layer."
11339824|NCT03638635|OG001|Outcome|Bupivacaine Liposome|"Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer."
11339825|NCT03638635|EG000|Reported Event|Standard Bupivacaine|"Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine: Abdominal injection of bupivacaine into fascial layer."
11339826|NCT03638635|EG001|Reported Event|Bupivacaine Liposome|"Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.~Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer."
11339827|NCT03638908|BG000|Baseline|Fluoxetine|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily~Fluoxetine"
11339828|NCT03638908|FG000|Participant Flow|Fluoxetine|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily~Fluoxetine"
11339829|NCT03638908|OG000|Outcome|Fluoxetine|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily"
11339830|NCT03638908|OG000|Outcome|Fluoxetine- Baseline|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily"
11339831|NCT03638908|OG000|Outcome|Fluoxetine- Baseline|subject data at baseline
11339832|NCT03638908|OG001|Outcome|Fluoxetine- Week 24|subject data at week 24
11339833|NCT03638908|OG000|Outcome|Fluoxetine|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily~Fluoxetine"
11339834|NCT03638908|EG000|Reported Event|Fluoxetine|"Dosing will be~Week 1-4: 20 mg daily~Week 5-8: 40 mg daily~Week 9-12: 60 mg daily~Week 13-24: 80 mg daily~Fluoxetine"
11339835|NCT03639675|BG000|Baseline|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Japanese patients with neovascular glaucoma
11339836|NCT03639675|FG000|Participant Flow|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Japanese patients with neovascular glaucoma
11339837|NCT03639675|OG000|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Japanese patients with neovascular glaucoma
11339838|NCT03639675|EG000|Reported Event|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Japanese patients with neovascular glaucoma
11379403|NCT03012672|EG000|Reported Event|ARM I (HIGHER-DOSE):|"ARM I (HIGHER-DOSE):~INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC) on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity."
11379404|NCT03012672|EG001|Reported Event|ARM II (LOWER-DOSE):|"ARM II (LOWER-DOSE):~INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11379405|NCT03011775|BG000|Baseline|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379406|NCT03011775|BG001|Baseline|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379407|NCT03011775|BG002|Baseline|Total|Total of all reporting groups
11379408|NCT03011775|FG000|Participant Flow|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379409|NCT03011775|FG001|Participant Flow|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379410|NCT03011775|OG000|Outcome|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379411|NCT03011775|OG001|Outcome|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379412|NCT03011775|OG000|Outcome|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day~During the observation of mortality from all-cause mortality, serious adverse events, other (Not Including Serious) adverse events among patients of study groups not recorded."
11379413|NCT03011775|OG001|Outcome|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day During the observation of mortality from all-cause mortality, serious adverse events, other (Not Including Serious) adverse events among patients of control groups not recorded."
10780856|NCT03698279|OG006|Outcome|Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780857|NCT03698279|OG007|Outcome|Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780858|NCT03698279|EG000|Reported Event|Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780859|NCT03698279|EG001|Reported Event|Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780860|NCT03698279|EG002|Reported Event|Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)|Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780861|NCT03698279|EG003|Reported Event|Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)|Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780862|NCT03698279|EG004|Reported Event|Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780863|NCT03698279|EG005|Reported Event|Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)|Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10780864|NCT03559010|BG000|Baseline|All Participants|"Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study.~The total number of subjects enrolled is 189. Out of the 189 subjects, 113 were included in the Purchaser population. And in 113 subjects included in Purchaser Population, 109 were in Use Phase (Users)."
10780865|NCT03559010|FG000|Participant Flow|Self Selection Population|Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study
10780866|NCT03559010|OG000|Outcome|Self Selection Population|Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study
10780867|NCT03559010|OG001|Outcome|Purchaser Population|During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product.
10780868|NCT03559010|OG002|Outcome|Use Phase Norgestrel 0.075 mg|"Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks~Norgestrel 0.075 mg tablets: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.~Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet."
10780869|NCT03559010|OG000|Outcome|Self-selection Population|Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study
10780870|NCT03559010|OG001|Outcome|Purchaser Population|During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product
10780871|NCT03559010|OG000|Outcome|Use Phase Norgestrel 0.075 mg|"Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks~Norgestrel 0.075 mg tablets: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.~Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet."
10780872|NCT03559010|EG000|Reported Event|Safety Population|Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study.
10964545|NCT00878189|FG008|Participant Flow|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11193538|NCT02146248|FG000|Participant Flow|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
11193539|NCT02146248|OG000|Outcome|Follicular Phase HSG|
11193540|NCT02146248|OG000|Outcome|Tubal Patency Change|Change in tubal patency after OC treatment
11193541|NCT02146248|OG000|Outcome|HSG 3|OC HSG
11193542|NCT02146248|OG000|Outcome|HSG 4|DMPA HSG
11193543|NCT02146248|OG000|Outcome|HSG 5|post DMPA OC HSG
11193544|NCT02146248|EG000|Reported Event|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
11193545|NCT02146274|BG000|Baseline|Ischemic Stroke Patients|Patients who have had an ischemic stroke
11193546|NCT02146274|FG000|Participant Flow|Ischemic Stroke Patients|Patients who have had an ischemic stroke
11193547|NCT02146274|OG000|Outcome|Ischemic Stroke Patients By Anti-depressant =Yes|Patients on Antidepressant at Discharge
11193548|NCT02146274|OG001|Outcome|Ischemic Stroke Patients By Anti-depressant =No|Patients not on Antidepressant at Discharge
11193549|NCT02146274|OG000|Outcome|Ischemic Stroke Patients on Antidepressant (n=222)|Ischemic stroke patients taking an antidepressant
11193550|NCT02146274|OG001|Outcome|Ischemic Stroke Patients Not Taking an Antidepressant (n=760)|Ischemic stroke patients not taking an antipressant.
11193551|NCT02146274|EG000|Reported Event|Ischemic Stroke Patients|Patients who have had an ischemic stroke that are hospitalized in an acute-care setting.
11193552|NCT02146326|BG000|Baseline|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11193553|NCT02146326|BG001|Baseline|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11379414|NCT03011775|OG000|Outcome|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: Pioglar (Ranbaxy India):1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~Ramipril 5 MG: 1 tablet per a day"
11379415|NCT03011775|OG001|Outcome|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~Ramipril 5 MG: 1 tablet per a day"
11193554|NCT02146326|BG002|Baseline|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
11193555|NCT02146326|BG003|Baseline|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
11193556|NCT02146326|BG004|Baseline|Total|Total of all reporting groups
11193557|NCT02146326|FG000|Participant Flow|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
11193558|NCT02146326|FG001|Participant Flow|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the Motivational Interviewing (MI) intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
11193559|NCT02146326|FG002|Participant Flow|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
11193560|NCT02146326|FG003|Participant Flow|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
11193561|NCT02146326|OG000|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11193562|NCT02146326|OG001|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
10780873|NCT03478930|BG000|Baseline|Received Placebo in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780874|NCT03478930|BG001|Baseline|Received Omalizumab in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780875|NCT03478930|BG002|Baseline|Total|Total of all reporting groups
10780876|NCT03478930|FG000|Participant Flow|Received Placebo in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780877|NCT03478930|FG001|Participant Flow|Received Omalizumab in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780878|NCT03478930|OG000|Outcome|Received Placebo in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780879|NCT03478930|OG001|Outcome|Received Omalizumab in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780880|NCT03478930|EG000|Reported Event|Received Placebo in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780881|NCT03478930|EG001|Reported Event|Received Omalizumab in GA39688 or GA39855|After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
10780882|NCT03434353|BG000|Baseline|Group 1: Inarigivir Soproxil 50 mg + TAF|Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780883|NCT03434353|BG001|Baseline|Group 2: TAF|Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
10780884|NCT03434353|BG002|Baseline|Group 3: Inarigivir Soproxil 200 mg + TAF|Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780885|NCT03434353|BG003|Baseline|Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)|Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
10780886|NCT03434353|BG004|Baseline|Group 5: Inarigivir Soproxil 400 mg + TAF|Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
10780887|NCT03434353|BG005|Baseline|Total|Total of all reporting groups
10780888|NCT03434353|FG000|Participant Flow|Group 1: Inarigivir Soproxil 50 mg + TAF|Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus tenofovir alafenamide (TAF) 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780889|NCT03434353|FG001|Participant Flow|Group 2: TAF|Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
11193563|NCT02146326|OG002|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
10780890|NCT03434353|FG002|Participant Flow|Group 3: Inarigivir Soproxil 200 mg + TAF|Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780891|NCT03434353|FG003|Participant Flow|Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)|Virally suppressed participants who were receiving commercially available nucleoside/nucleotide (NUC[s]) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
10780892|NCT03434353|FG004|Participant Flow|Group 5: Inarigivir Soproxil 400 mg + TAF|Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
10780893|NCT03434353|OG000|Outcome|Group 1: Inarigivir Soproxil 50 mg + TAF|Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780894|NCT03434353|OG001|Outcome|Group 2: TAF|Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
10780895|NCT03434353|OG002|Outcome|Group 3: Inarigivir Soproxil 200 mg + TAF|Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
10780896|NCT03434353|OG003|Outcome|Group 5: Inarigivir Soproxil 400 mg + TAF|Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
10780897|NCT03434353|OG000|Outcome|Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)|Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
10780898|NCT03434353|EG000|Reported Event|Group 1: Inarigivir Soproxil 50 mg + TAF|Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
11193564|NCT02146326|OG003|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
11193565|NCT02146326|OG001|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11193566|NCT02146326|OG000|Outcome|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the BREATHE intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
10964546|NCT00878189|OG000|Outcome|PF-03084014 20 mg BID in Solid Tumor Participants|PF-03084014 20 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11193567|NCT02146326|OG001|Outcome|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the MI intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
11193568|NCT02146326|OG002|Outcome|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
11193569|NCT02146326|OG003|Outcome|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
10780899|NCT03434353|EG001|Reported Event|Group 2: TAF|Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
10780900|NCT03434353|EG002|Reported Event|Group 3: Inarigivir Soproxil 200 mg + TAF|Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
11193570|NCT02146326|OG003|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
10780901|NCT03434353|EG003|Reported Event|Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)|Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks.
10780902|NCT03434353|EG004|Reported Event|Group 5: Inarigivir Soproxil 400 mg + TAF|Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
10780903|NCT03415022|BG000|Baseline|4-week Computer-based Treatment|"A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.~computer-based treatment: 30 minute sessions of free viewing of faces and listening to music"
10780904|NCT03415022|BG001|Baseline|8-week Computer-based Treatment|"An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.~computer-based treatment: 30 minute sessions of free viewing of faces and listening to music"
10780905|NCT03415022|BG002|Baseline|Total|Total of all reporting groups
11379416|NCT03011775|EG000|Reported Event|Pioglitazone + Standard Care|"20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.~Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379417|NCT03011775|EG001|Reported Event|Standard Care|"23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.~Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day~Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day~Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day~Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day~ramipril 5 MG: 1 tablet per a day"
11379418|NCT03007485|BG000|Baseline|Standard of Care|Standard pulmonary rehabilitation
11379419|NCT03007485|BG001|Baseline|Intervention|"Telehealth delivered pulmonary rehabilitation~Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."
11379420|NCT03007485|BG002|Baseline|Total|Total of all reporting groups
11379421|NCT03007485|FG000|Participant Flow|Standard of Care|Standard pulmonary rehabilitation
11379422|NCT03007485|FG001|Participant Flow|Telehealth-delivered Pulmonary Rehabilitation|"Telehealth delivered pulmonary rehabilitation- Intervention~Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."
11379423|NCT03007485|OG000|Outcome|Intention to Treat (ITT)|ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants
11379424|NCT03007485|OG001|Outcome|Medically Cleared|Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.
11379425|NCT03007485|OG002|Outcome|Bike|Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
11379426|NCT03007485|OG000|Outcome|Standard of Care|Standard pulmonary rehabilitation
11379427|NCT03007485|OG001|Outcome|Telehealth-delivered Pulmonary Rehabilitation|"Telehealth delivered pulmonary rehabilitation~Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."
11379428|NCT03007485|OG000|Outcome|Telehealth-delivered Pulmonary Rehabilitation|Telehealth-delivered Pulmonary Rehabilitation
11379429|NCT03007485|OG001|Outcome|Intervention|"Telehealth delivered pulmonary rehabilitation~Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."
11379430|NCT03007485|EG000|Reported Event|Standard of Care|Standard pulmonary rehabilitation
11379431|NCT03007485|EG001|Reported Event|Telehealth-delivered Pulmonary Rehabilitation|"Telehealth delivered pulmonary rehabilitation~Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."
11379432|NCT02998476|BG000|Baseline|Group A Parsaclisib (no Prior BTK Inhibitor)|Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
11379433|NCT02998476|BG001|Baseline|Group B Parsaclisib (Prior BTK Inhibitor)|Parsaclisib in subjects who were previously treated with a BTK inhibitor.
11379434|NCT02998476|BG002|Baseline|Total|Total of all reporting groups
11379435|NCT02998476|FG000|Participant Flow|Group A Parsaclisib (no Prior BTK Inhibitor)|Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
11379436|NCT02998476|FG001|Participant Flow|Group B Parsaclisib (Prior BTK Inhibitor)|Parsaclisib in subjects who were previously treated with a BTK inhibitor.
11379437|NCT02998476|OG000|Outcome|Group A Parsaclisib (no Prior BTK Inhibitor)|Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
11379438|NCT02998476|OG001|Outcome|Group B Parsaclisib (Prior BTK Inhibitor)|Parsaclisib in subjects who were previously treated with a BTK inhibitor.
11379439|NCT02998476|EG000|Reported Event|Group A Parsaclisib (no Prior BTK Inhibitor)|Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
11379440|NCT02998476|EG001|Reported Event|Group B Parsaclisib (Prior BTK Inhibitor)|Parsaclisib in subjects who were previously treated with a BTK inhibitor.
11379441|NCT02998476|EG002|Reported Event|Total|Total
11379442|NCT02960997|BG000|Baseline|Sirolimus, Then Placebo|Participants will receive Sirolimus, 2% topical ointment for 12 weeks followed by placebo to match sirolimus for 12 weeks.
11193571|NCT02146326|EG000|Reported Event|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11379443|NCT02960997|BG001|Baseline|Placebo, Then Sirolimus|Participants will receive placebo to match sirolimus for 12 weeks followed by Sirolimus, 2% topical ointment for 12 weeks.
11379444|NCT02960997|BG002|Baseline|Total|Total of all reporting groups
11379445|NCT02960997|FG000|Participant Flow|Sirolimus, Then Placebo|Participants will receive Sirolimus, 2% topical ointment for 12 weeks followed by placebo to match sirolimus for 12 weeks.
11379446|NCT02960997|FG001|Participant Flow|Placebo, Then Sirolimus|Participants will receive placebo to match sirolimus for 12 weeks followed by Sirolimus, 2% topical ointment for 12 weeks.
11379447|NCT02960997|OG000|Outcome|Sirolimus|Sirolimus, 2% topical ointment for 12 weeks
11379448|NCT02960997|OG001|Outcome|Placebo|Placebo to match sirolimus for 12 weeks
11379449|NCT02960997|EG000|Reported Event|Sirolimus|Sirolimus, 2% topical ointment for 12 weeks
11193572|NCT02146326|EG001|Reported Event|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
11379450|NCT02960997|EG001|Reported Event|Placebo|Placebo to match sirolimus for 12 weeks
11379451|NCT02949128|BG000|Baseline|Ravulizumab|"Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.~After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first."
11379452|NCT02949128|FG000|Participant Flow|Ravulizumab|"Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.~After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first."
11379453|NCT02949128|OG000|Outcome|Ravulizumab|Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
11379454|NCT02949128|EG000|Reported Event|Ravulizumab|"Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.~After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first."
11379455|NCT02924064|BG000|Baseline|Teneligliptin 20mg + Metformin|Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
11379456|NCT02924064|BG001|Baseline|Placebo + Metformin|Placebo for 24 weeks in combination with metformin.
11379457|NCT02924064|BG002|Baseline|Total|Total of all reporting groups
11379458|NCT02924064|FG000|Participant Flow|Teneligliptin 20mg + Metformin|Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
11379459|NCT02924064|FG001|Participant Flow|Placebo + Metformin|Placebo for 24 weeks in combination with metformin.
11379460|NCT02924064|OG000|Outcome|Teneligliptin 20mg + Metformin|Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
11379461|NCT02924064|OG001|Outcome|Placebo + Metformin|Placebo for 24 weeks in combination with metformin.
11379462|NCT02924064|EG000|Reported Event|Teneligliptin 20mg + Metformin|Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
11379463|NCT02924064|EG001|Reported Event|Placebo + Metformin|Placebo for 24 weeks in combination with metformin.
11379464|NCT02916706|BG000|Baseline|Teneligliptin 20mg|Teneligliptin (20mg once daily) for 24 weeks
11379465|NCT02916706|BG001|Baseline|Placebo|Placebo for 24 weeks
11379466|NCT02916706|BG002|Baseline|Total|Total of all reporting groups
11379467|NCT02916706|FG000|Participant Flow|Teneligliptin 20mg|Teneligliptin (20mg once daily) for 24 weeks
11379468|NCT02916706|FG001|Participant Flow|Placebo|Placebo for 24 weeks
11379469|NCT02916706|OG000|Outcome|Teneligliptin 20mg|Teneligliptin (20mg once daily) for 24 weeks
11379470|NCT02916706|OG001|Outcome|Placebo|Placebo for 24 weeks
11379471|NCT02916706|EG000|Reported Event|Teneligliptin 20mg|Teneligliptin (20mg once daily) for 24 weeks
11379472|NCT02916706|EG001|Reported Event|Placebo|Placebo for 24 weeks
11379473|NCT02889900|BG000|Baseline|Cediranib + Olaparib|Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
11379474|NCT02889900|FG000|Participant Flow|Cediranib + Olaparib|Patients received a combination of cediranib 30 milligrams (mg) orally once daily (qd) and olaparib 200 mg orally twice daily (bid) until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
11379475|NCT02889900|OG000|Outcome|Cediranib + Olaparib|Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
11379476|NCT02889900|EG000|Reported Event|Cediranib + Olaparib|Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
10780906|NCT03415022|FG000|Participant Flow|4-week Computer-based Treatment|"A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.~Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music"
10780907|NCT03415022|FG001|Participant Flow|8-week Computer-based Treatment|An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
10780908|NCT03415022|OG000|Outcome|4-week Computer-based Treatment|"A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.~Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music"
10780909|NCT03415022|OG001|Outcome|8-week Computer-based Treatment|An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
10780910|NCT03415022|EG000|Reported Event|4-week Computer-based Treatment|"A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.~Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music"
10780911|NCT03415022|EG001|Reported Event|8-week Computer-based Treatment|An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
10780912|NCT03283670|BG000|Baseline|Study Participants|"Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.~25% nitrous oxide, 25% nitrogen, 25% oxygen~50% nitrous oxide, 50% oxygen~Placebo gas: 50% nitrogen(inert), 50% oxygen"
11193573|NCT02146326|EG002|Reported Event|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
11193574|NCT02146326|EG003|Reported Event|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
11193575|NCT02146352|BG000|Baseline|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
10780913|NCT03283670|FG000|Participant Flow|Study Participants|"Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.~25% nitrous oxide, 25% nitrogen, 25% oxygen~50% nitrous oxide, 50% oxygen~Placebo gas: 50% nitrogen(inert), 50% oxygen"
11193576|NCT02146352|FG000|Participant Flow|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
11193577|NCT02146352|OG000|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
11193578|NCT02146352|EG000|Reported Event|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
10780914|NCT03283670|OG000|Outcome|25% Nitrous Oxide|25% nitrous oxide, 25% nitrogen, 25% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
10780915|NCT03283670|OG001|Outcome|50% Nitrous Oxide|50% nitrous oxide, 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
10780916|NCT03283670|OG002|Outcome|Placebo Gas|50% nitrogen(inert), 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
10780917|NCT03283670|EG000|Reported Event|Placebo|Placebo gas: 50% nitrogen(inert), 50% oxygen
10780918|NCT03283670|EG001|Reported Event|25% Nitrous Oxide|25% nitrous oxide, 25% nitrogen, 25% oxygen
10780919|NCT03283670|EG002|Reported Event|50% Nitrous Oxide|50% nitrous oxide, 50% oxygen
10780920|NCT03233217|BG000|Baseline|Cohort 1: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780921|NCT03233217|BG001|Baseline|Cohort 1: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780922|NCT03233217|BG002|Baseline|Cohort 2: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780923|NCT03233217|BG003|Baseline|Cohort 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780924|NCT03233217|BG004|Baseline|Cohort 2: QIV-SD by SC|Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
10780925|NCT03233217|BG005|Baseline|Total|Total of all reporting groups
10780926|NCT03233217|FG000|Participant Flow|Cohort 1: QIV-HD by IM|Participants were randomized to receive a single 0.7-milliliter (mL) injection of high-dose Quadrivalent influenza vaccine (QIV-HD) by IM route on Day 0.
10780927|NCT03233217|FG001|Participant Flow|Cohort 1: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780928|NCT03233217|FG002|Participant Flow|Cohort 2: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780929|NCT03233217|FG003|Participant Flow|Cohort 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780930|NCT03233217|FG004|Participant Flow|Cohort 2: QIV-SD by SC|Participants were randomized to receive a single 0.5 mL injection of standard-dose Quadrivalent influenza vaccine (QIV-SD) by SC route on Day 0.
11193579|NCT02146365|BG000|Baseline|PATH-wSP 300 µg + Booster|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193580|NCT02146365|BG001|Baseline|PATH-wSP 300 µg Only|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193581|NCT02146365|BG002|Baseline|PATH-wSP 600 µg + Booster|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11379477|NCT02866695|BG000|Baseline|Open Label Treatment|"All patients will be treated with ingenol mebutate gel 0.015%. There is no placebo or comparator for this study. The investigator will identify the patient's treatment area at Baseline, and provide a detailed application instruction sheet. The first dose will be applied in clinic under the supervision of the investigator.~ingenol mebutate gel 0.015%: ingenol mebutate gel 0.015% to be applied on treatment area"
11379478|NCT02866695|FG000|Participant Flow|Open Label Treatment|A total of 20 solid organ transplant recipients with 4 to 20 actinic keratoses were enrolled and treated for 3 consecutive days with 4 single-dose tubes of ingenol mebutate gel 0.015% applied to a 100 cm2 area of the face according to study protocol. There was no placebo or comparator for this study. All but 2 participants completed the treatment. One kidney transplant participant forgot to apply the treatment on day 3, but continued in the study. One lung transplant participant who reported pain in the treatment area withdrew from the study after day 2 dosing due to travel considerations and was lost to follow-up.
11379479|NCT02866695|OG000|Outcome|Open Label Treatment|A total of 20 solid organ transplant recipients with 4 to 20 actinic keratoses were enrolled and treated for 3 consecutive days with 4 single-dose tubes of ingenol mebutate gel 0.015% applied to a 100 cm2 area of the face according to study protocol. There was no placebo or comparator for this study. All but 2 participants completed the treatment. One kidney transplant participant forgot to apply the treatment on day 3, but continued in the study. One lung transplant participant who reported pain in the treatment area withdrew from the study after day 2 dosing due to travel considerations and was lost to follow-up.
11379480|NCT02866695|EG000|Reported Event|Open Label Treatment|A total of 20 solid organ transplant recipients with 4 to 20 actinic keratoses were enrolled and treated for 3 consecutive days with 4 single-dose tubes of ingenol mebutate gel 0.015% applied to a 100 cm2 area of the face according to study protocol. There was no placebo or comparator for this study. All but 2 participants completed the treatment. One kidney transplant participant forgot to apply the treatment on day 3, but continued in the study. One lung transplant participant who reported pain in the treatment area withdrew from the study after day 2 dosing due to travel considerations and was lost to follow-up.
11379481|NCT02854436|BG000|Baseline|Niraparib|Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
11379482|NCT02854436|FG000|Participant Flow|Niraparib|Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
11379483|NCT02854436|OG000|Outcome|Niraparib|Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
11379484|NCT02854436|EG000|Reported Event|Niraparib|Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
11379485|NCT02834793|BG000|Baseline|Core Study Phase: Placebo|Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks.
11379486|NCT02834793|BG001|Baseline|Core Study Phase: Perampanel|Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks.
11379487|NCT02834793|BG002|Baseline|Total|Total of all reporting groups
11193582|NCT02146365|BG003|Baseline|PATH-wSP 600 µg Only|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193583|NCT02146365|BG004|Baseline|Booster Only (Both Cohorts)|Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
11379488|NCT02834793|FG000|Participant Flow|Core Study Phase: Placebo|Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks.
11379489|NCT02834793|FG001|Participant Flow|Core Study Phase: Perampanel|Participants received starting dose of perampanel, one 2 milligram (mg) oral tablet or 4 milliliter (mL) oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 milligram per day (mg/day) during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks.
11379490|NCT02834793|FG002|Participant Flow|Extension Phase A: Perampanel|Participants who completed the Core Study Phase and who were eligible entered into Extension Phase A. Participants previously assigned to perampanel arm (Core Study Phase) continued taking study medication at the dose received during the Core maintenance period, and participants previously assigned to a placebo arm (Core Study Phase) started perampanel dose as one 2 mg tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to a maximum dose of 8 mg/day for 6 weeks conversion period of Extension Phase A. After the conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during the maintenance period (46 weeks) of Extension Phase A as per the investigator's discretion. The total duration of the conversion period and maintenance period in Extension Phase A was 52 weeks.
11379491|NCT02834793|FG003|Participant Flow|Extension Phase B: Perampanel|Participants who completed Extension Phase A and who were eligible entered into Extension Phase B. Participants received perampanel at their optimal perampanel dose (that is, dose maintained at the end of Extension A) until perampanel was available commercially or accessible via extended access program (EAP) (in the country in which a participant resides) or unless study termination by the sponsor (up to 188 weeks).
11379492|NCT02834793|OG000|Outcome|Core Study Phase: Placebo|Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks.
11379493|NCT02834793|OG001|Outcome|Core Study Phase: Perampanel|Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks.
11379494|NCT02834793|OG002|Outcome|Extension Phase: Perampanel|Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period, and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks).
11379495|NCT02834793|EG000|Reported Event|Core Study Phase: Placebo|Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks.
11379496|NCT02834793|EG001|Reported Event|Core Study Phase: Perampanel|Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks.
11379497|NCT02834793|EG002|Reported Event|Extension Phase: Perampanel|Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period; and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks).
11379498|NCT02810457|BG000|Baseline|FKB238 / Paclitaxel / Carboplatin|"Drug: FKB238:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~FKB238 (bevacizumab)~Paclitaxel~Carboplatin"
10780931|NCT03233217|OG000|Outcome|Cohort 1 and 2: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780932|NCT03233217|OG001|Outcome|Cohort 1 and 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780933|NCT03233217|OG002|Outcome|Cohort 2: QIV-SD by SC|Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
10780934|NCT03233217|OG001|Outcome|Cohort 1 and 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0
10780935|NCT03233217|OG000|Outcome|Cohort 2: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780936|NCT03233217|OG001|Outcome|Cohort 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780937|NCT03233217|OG001|Outcome|Cohort 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0
10780938|NCT03233217|EG000|Reported Event|Cohort 1 and 2: QIV-HD by IM|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
10780939|NCT03233217|EG001|Reported Event|Cohort 1 and 2: QIV-HD by SC|Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
10780940|NCT03233217|EG002|Reported Event|Cohort 2: QIV-SD by SC|Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
10780941|NCT03219567|BG000|Baseline|Normals|"Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye."
10780942|NCT03219567|BG001|Baseline|Patients With a History of Cataract Surgery or High Myopia|"Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.~Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body."
10780943|NCT03219567|BG002|Baseline|Total|Total of all reporting groups
10780944|NCT03219567|FG000|Participant Flow|Normals|"Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye."
10780945|NCT03219567|FG001|Participant Flow|Patients With a History of Cataract Surgery or High Myopia|"Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.~Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body."
11193584|NCT02146365|BG005|Baseline|No Intervention|Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
11193585|NCT02146365|BG006|Baseline|Total|Total of all reporting groups
10780946|NCT03219567|OG000|Outcome|Normals|"Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye."
10780947|NCT03219567|OG001|Outcome|Patients With Previous LASIK Who Will be Undergoing Cataract Surgery|"Patients with previous LASIK who will be undergoing cataract surgery subjects will be imaged with the OCT system.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye."
10780948|NCT03219567|OG002|Outcome|Patients With a History of Cataract Surgery or High Myopia|"Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.~Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body."
11193586|NCT02146365|FG000|Participant Flow|PATH-wSP 300 µg + Booster|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193587|NCT02146365|FG001|Participant Flow|PATH-wSP 300 µg Only|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
10964547|NCT00878189|OG001|Outcome|PF-03084014 40 mg BID in Solid Tumor Participants|PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11379499|NCT02810457|BG001|Baseline|Avastin / Paclitaxel / Carboplatin|"Drug: Avastin:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Avastin (bevacizumab)~Paclitaxel~Carboplatin"
11379500|NCT02810457|BG002|Baseline|Total|Total of all reporting groups
11379501|NCT02810457|FG000|Participant Flow|FKB238 / Paclitaxel / Carboplatin|"Drug: FKB238:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~Area under the curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~FKB238 (bevacizumab)~Paclitaxel~Carboplatin"
11379502|NCT02810457|FG001|Participant Flow|Avastin / Paclitaxel / Carboplatin|"Drug: Avastin:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Avastin (bevacizumab)~Paclitaxel~Carboplatin"
11379503|NCT02810457|OG000|Outcome|FKB238 / Paclitaxel / Carboplatin|"Drug: FKB238:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~FKB238 (bevacizumab)~Paclitaxel~Carboplatin"
11379504|NCT02810457|OG001|Outcome|Avastin / Paclitaxel / Carboplatin|"Drug: Avastin:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Avastin (bevacizumab)~Paclitaxel~Carboplatin"
11379505|NCT02810457|EG000|Reported Event|FKB238 / Paclitaxel / Carboplatin|"Drug: FKB238:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~FKB238 (bevacizumab)~Paclitaxel~Carboplatin"
11379506|NCT02810457|EG001|Reported Event|Avastin / Paclitaxel / Carboplatin|"Drug: Avastin:~15 mg/kg IV infusion on Day 1 of each 21-day cycle.~Drug: Paclitaxel:~200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Drug: Carboplatin:~AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.~Avastin (bevacizumab)~Paclitaxel~Carboplatin"
11379507|NCT02797964|BG000|Baseline|Colorectal Cancer|Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379508|NCT02797964|BG001|Baseline|High Grade Serous Ovarian Cancer|High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
11379509|NCT02797964|BG002|Baseline|Non Small Cell Lung Cancer|Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379510|NCT02797964|BG003|Baseline|Metastatic Other Tumor Type Castration Resistant Prostate Cancer|Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
11379511|NCT02797964|BG004|Baseline|Head and Neck Squamous Cell Carcinoma|Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
11379512|NCT02797964|BG005|Baseline|Other Tumor Type|Any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, that had relapsed after or progressing despite conventional treatment for which no conventional therapy was considered appropriate by the investigator or had been declined by the subject.
11379513|NCT02797964|BG006|Baseline|Total|Total of all reporting groups
11379514|NCT02797964|FG000|Participant Flow|Colorectal Cancer|Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379515|NCT02797964|FG001|Participant Flow|High Grade Serous Ovarian Cancer|High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
11379516|NCT02797964|FG002|Participant Flow|Non Small Cell Lung Cancer|Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379517|NCT02797964|FG003|Participant Flow|Metastatic Other Tumor Type Castration Resistant Prostate Cancer|Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
11379518|NCT02797964|FG004|Participant Flow|Head and Neck Squamous Cell Carcinoma|Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
11379519|NCT02797964|FG005|Participant Flow|Other Tumor Type|Any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, that had relapsed after or progressing despite conventional treatment for which no conventional therapy was considered appropriate by the investigator or had been declined by the subject.
10780949|NCT03219567|EG000|Reported Event|Normals|"Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye."
10780950|NCT03219567|EG001|Reported Event|Patients With a History of Cataract Surgery or High Myopia|"Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.~Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.~The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.~Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body."
10780951|NCT03205358|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
10780952|NCT03205358|BG001|Baseline|Group 2: NIMENRIX®|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
10780953|NCT03205358|BG002|Baseline|Total|Total of all reporting groups
10780954|NCT03205358|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine.
11193588|NCT02146365|FG002|Participant Flow|PATH-wSP 600 µg + Booster|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193589|NCT02146365|FG003|Participant Flow|PATH-wSP 600 µg Only|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193590|NCT02146365|FG004|Participant Flow|Booster Only (300 µg)|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
11193591|NCT02146365|FG005|Participant Flow|Booster Only (600 µg)|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
11193592|NCT02146365|FG006|Participant Flow|No Intervention (300 µg)|Toddlers who enrolled during Cohort 1 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
11193593|NCT02146365|FG007|Participant Flow|No Intervention (600 µg)|Toddlers who enrolled during Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
11193594|NCT02146365|OG000|Outcome|Combined PATH-wSP 300 µg|All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
10780955|NCT03205358|FG001|Participant Flow|Group 2: NIMENRIX®|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
10780956|NCT03205358|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
10780957|NCT03205358|OG001|Outcome|Group 2: NIMENRIX®|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
10780958|NCT03205358|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
11193595|NCT02146365|OG001|Outcome|Combined Control (300 µg)|Participants enrolled during Cohort 1 who received booster-only or no intervention.
11193596|NCT02146365|OG002|Outcome|Combined PATH-wSP 600 µg|All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
11193597|NCT02146365|OG003|Outcome|Combined Control (600 µg)|All participants enrolled during Cohort 2 who received booster-only or no intervention.
11193598|NCT02146365|OG000|Outcome|PATH-wSP 300 µg + Booster|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193599|NCT02146365|OG001|Outcome|PATH-wSP 300 µg Only|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193600|NCT02146365|OG002|Outcome|PATH-wSP 600 µg + Booster|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193601|NCT02146365|OG003|Outcome|PATH-wSP 600 µg Only|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193602|NCT02146365|OG004|Outcome|Booster Only (Both Cohorts)|Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
11193603|NCT02146365|OG005|Outcome|No Intervention|Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
11193604|NCT02146365|EG000|Reported Event|PATH-wSP 300 µg + Booster|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11379520|NCT02797964|OG000|Outcome|Safety Evaluable Population|The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.
10780959|NCT03205358|EG001|Reported Event|Group 2: NIMENRIX®|Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
11193605|NCT02146365|EG001|Reported Event|PATH-wSP 300 µg Only|Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
11193606|NCT02146365|EG002|Reported Event|PATH-wSP 600 µg + Booster|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193607|NCT02146365|EG003|Reported Event|PATH-wSP 600 µg Only|Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
11193608|NCT02146365|EG004|Reported Event|Booster Only (Both Cohorts)|Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
11193609|NCT02146365|EG005|Reported Event|No Intervention|Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
11193610|NCT02146430|BG000|Baseline|Placebo|Placebo for oral administration matching capsule for DS-5565 and matching tablet for pregabalin
11193611|NCT02146430|BG001|Baseline|Pregabalin|Participants take one pregabalin capsule and one placebo tablet BID
10780960|NCT03153111|BG000|Baseline|Macitentan|Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
10780961|NCT03153111|BG001|Baseline|Placebo|Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
10780962|NCT03153111|BG002|Baseline|Total|Total of all reporting groups
10780963|NCT03153111|FG000|Participant Flow|Macitentan|Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
10780964|NCT03153111|FG001|Participant Flow|Placebo|Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
10780965|NCT03153111|OG000|Outcome|Macitentan|Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
10780966|NCT03153111|OG001|Outcome|Placebo|Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
10964548|NCT00878189|OG002|Outcome|PF-03084014 80 mg BID in Solid Tumor Participants|PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11193612|NCT02146430|BG002|Baseline|DS-5565 QD|Participants take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
11193613|NCT02146430|BG003|Baseline|DS-5565 BID|Participants take one DS-5565 tablet and one placebo capsule BID
11193614|NCT02146430|BG004|Baseline|Total|Total of all reporting groups
11193615|NCT02146430|FG000|Participant Flow|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11193616|NCT02146430|FG001|Participant Flow|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11193617|NCT02146430|FG002|Participant Flow|DS-5565 QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11193618|NCT02146430|FG003|Participant Flow|DS-5565 BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11193619|NCT02146430|OG000|Outcome|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11193620|NCT02146430|OG001|Outcome|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11193621|NCT02146430|OG002|Outcome|DS-5565 15 mg QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11193622|NCT02146430|OG003|Outcome|DS-5565 15 mg BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11193623|NCT02146430|OG000|Outcome|Placebo|Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).
11193624|NCT02146430|OG001|Outcome|Pregabalin 150 mg BID|Participants who received oral pregabalin 150 mg twice daily (BID).
11193625|NCT02146430|OG002|Outcome|DS-5565 15 mg QD|Participants who received oral DS5565 15 mg once daily (QD).
11193626|NCT02146430|OG003|Outcome|DS-5565 15 mg BID|Participants who received DS-5565 15 mg twice daily (BID).
11193627|NCT02146430|EG000|Reported Event|Placebo|Placebo for oral administration matching capsule for DS-5565 and matching tablet for pregabalin
11193628|NCT02146430|EG001|Reported Event|Pregabalin|Participants take one pregabalin capsule and one placebo tablet BID
11193629|NCT02146430|EG002|Reported Event|DS-5565 QD|Participants take one each of placebo tablet and capsule in the morning and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
11193630|NCT02146430|EG003|Reported Event|DS-5565 BID|Participants take one DS-5565 tablet and one placebo capsule BID
11193631|NCT02146482|BG000|Baseline|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
11379521|NCT02797964|OG000|Outcome|Dose Escalation Phase|The Dose Escalation Phase included a total of 18 subjects in 9 different dosage cohorts: 20 mg QD, 40 mg QD, 80 mg QD, 160 mg QD, 300 mg QD, 600 mg QD, 1000 mg QD, 500 mg BID, and 1300 mg QD.
10780967|NCT03153111|EG000|Reported Event|Macitentan|Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
10780968|NCT03153111|EG001|Reported Event|Placebo|Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
10780969|NCT03073733|BG000|Baseline|Sham Treated Control|Mock injection: pressing the hub of a syringe with no needle against the study eye to mimic intravitreal injection
10780970|NCT03073733|BG001|Baseline|Test (jCell Injection) Dose Level 1|single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye
10780971|NCT03073733|BG002|Baseline|Test (jCell Injection) Dose Level 2|single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye
10780972|NCT03073733|BG003|Baseline|Total|Total of all reporting groups
11379522|NCT02797964|OG000|Outcome|Colorectal Cancer|Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379523|NCT02797964|OG001|Outcome|High Grade Serous Ovarian Cancer|High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
11379524|NCT02797964|OG002|Outcome|Non Small Cell Lung Cancer|Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
11379525|NCT02797964|OG003|Outcome|Metastatic Other Tumor Type Castration Resistant Prostate Cancer|Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
11379526|NCT02797964|OG004|Outcome|Head and Neck Squamous Cell Carcinoma|Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
11379527|NCT02797964|OG003|Outcome|Metastatic Castration Resistant Prostate Cancer|Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
11379528|NCT02797964|OG005|Outcome|Other Tumor Type|Any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, that had relapsed after or progressing despite conventional treatment for which no conventional therapy was considered appropriate by the investigator or had been declined by the subject.
11379529|NCT02797964|OG006|Outcome|Overall|All subjects included in the Response Evaluable Population
11379530|NCT02797964|EG000|Reported Event|Safety Evaluable Population|Due to the small numbers of patients in some tumor type subgroups and with the intention of displaying the overall safety profile of SRA737 in advanced solid tumors, the frequency of each AE was evaluated in the overall Safety Evaluable Population rather than by tumor type subgroups. The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.
11379531|NCT02746809|BG000|Baseline|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.>~> CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:>~Evolut 34R Transcatheter Aortic Valve (TAV)>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath>~EnVeo R Loading System (LS)"
11379532|NCT02746809|FG000|Participant Flow|CoreValve Evolut R TAVR System 34R Valve|"The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R 20Fr Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
11379533|NCT02746809|OG000|Outcome|CoreValve Evolut 34R TAVR System|Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
11379534|NCT02746809|OG000|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~EnVeo R Loading System (LS)"
11379535|NCT02746809|OG000|Outcome|CoreValve Evolut 34R TAVR System|"Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.~>~>~CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut 34R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)"
10964549|NCT00878189|OG003|Outcome|PF-03084014 100 mg BID in Solid Tumor Participants|PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11379536|NCT02746809|EG000|Reported Event|EVOLUTR 34R|Participants implanted with EVOLUTR 34R device
11379537|NCT02745535|BG000|Baseline|SOF/VEL/VOX|Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks in participants with chronic hepatitis c previously exposed to direct acting antivirals (DAA).
11379538|NCT02745535|FG000|Participant Flow|SOF/VEL/VOX|Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks in participants with chronic hepatitis c previously exposed to direct acting antivirals (DAA).
11379539|NCT02745535|OG000|Outcome|SOF/VEL/VOX|Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks in participants with chronic hepatitis c previously exposed to direct acting antivirals (DAA).
11379540|NCT02745535|EG000|Reported Event|SOF/VEL/VOX|Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks in participants with chronic hepatitis c previously exposed to direct acting antivirals (DAA).
11379541|NCT02738853|BG000|Baseline|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
11379542|NCT02738853|FG000|Participant Flow|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
10780973|NCT03073733|FG000|Participant Flow|Sham Treated Control|Mock injection: pressing the hub of a syringe with no needle against the study eye to mimic intravitreal injection.
10780974|NCT03073733|FG001|Participant Flow|Test (jCell Injection) Dose Level 1|Single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye
10780975|NCT03073733|FG002|Participant Flow|Test (jCell Injection) Dose Level 2|Single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye
10780976|NCT03073733|OG000|Outcome|Sham Treated Control|Mock injection: pressing the hub of a syringe with no needle against the study eye to mimic intravitreal injection
10780977|NCT03073733|OG001|Outcome|Test (jCell Injection) Dose Level 1|Single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye
10780978|NCT03073733|OG002|Outcome|Test (jCell Injection) Dose Level 2|Single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye
10780979|NCT03073733|OG001|Outcome|Test (jCell Injection) Dose Level 1|single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye
10780980|NCT03073733|OG002|Outcome|Test (jCell Injection) Dose Level 2|single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye
10780981|NCT03073733|EG000|Reported Event|Sham Treated Control|Mock injection: pressing the hub of a syringe with no needle against the study eye
10780982|NCT03073733|EG001|Reported Event|Test (jCell Injection) Dose Level 1|Single intravitreal injection of 3.0 x 10e6 retinal progenitor cells into the study eye
10780983|NCT03073733|EG002|Reported Event|Test (jCell Injection) Dose Level 2|Single intravitreal injection of 6.0 x 10e6 retinal progenitor cells into the study eye
10780984|NCT02821000|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 2 mg/kg IV on Day 1 of each 21-day cycle.
10780985|NCT02821000|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 2 mg/kg intravenous (IV) on Day 1 of each 21-day cycle.
10780986|NCT02821000|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 2 mg/kg IV on Day 1 of each 21-day cycle.
10780987|NCT02821000|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 2 mg/kg IV on Day 1 of each 21-day cycle.
10780988|NCT02749968|BG000|Baseline|Liposomal Bupivacaine|"1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780989|NCT02749968|BG001|Baseline|0.9% Sodium Chloride|"1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780990|NCT02749968|BG002|Baseline|Total|Total of all reporting groups
10780991|NCT02749968|FG000|Participant Flow|Liposomal Bupivacaine|"1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780992|NCT02749968|FG001|Participant Flow|0.9% Sodium Chloride|"1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780993|NCT02749968|OG000|Outcome|Liposomal Bupivacaine|"1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780994|NCT02749968|OG001|Outcome|0.9% Sodium Chloride|"1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780995|NCT02749968|EG000|Reported Event|Liposomal Bupivacaine|"1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780996|NCT02749968|EG001|Reported Event|0.9% Sodium Chloride|"1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position~0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position"
10780997|NCT02738255|BG000|Baseline|Polysomnogram With Varnum First, Regular Polysomnogram Second|Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece.
10780998|NCT02738255|BG001|Baseline|Regular Polysomnogram First, Polysomnogram With Varnum Second|Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night.
10780999|NCT02738255|BG002|Baseline|Total|Total of all reporting groups
10781000|NCT02738255|FG000|Participant Flow|Polysomnogram With Varnum First, Regular Polysomnogram Second|Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece.
10781001|NCT02738255|FG001|Participant Flow|Regular Polysomnogram First, Polysomnogram With Varnum Second|Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night.
10781002|NCT02738255|OG000|Outcome|Polysomnogram With Varnum Mouthpiece|Varnum mouthpiece, similar to a mouth tape with central opening
10781003|NCT02738255|OG001|Outcome|Regular Polysomnogram|Overnight sleep study without Varnum mouthpiece
11193632|NCT02146482|BG001|Baseline|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
11193633|NCT02146482|BG002|Baseline|Total|Total of all reporting groups
11379543|NCT02738853|OG000|Outcome|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|"Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System~Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement."
11379544|NCT02738853|EG000|Reported Event|TAVR 2.0|Participants implanted with the TAVR 2.0 system
11379545|NCT02729701|BG000|Baseline|Duavee|"Participants will be asked to take Duavee for 6 months while on the study.~Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))"
11379546|NCT02729701|FG000|Participant Flow|Duavee|"Participants asked to take Duavee for 6 months while on the study.~Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))"
11379547|NCT02729701|OG000|Outcome|Duavee|"Participants asked to take Duavee for 6 months while on the study.~Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))"
11379548|NCT02729701|EG000|Reported Event|Duavee|"Participants asked to take Duavee for 6 months while on the study.~Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))"
11379549|NCT02684253|BG000|Baseline|Nivolumab 3mg/kg IV Every 2 Weeks|"Nivolumab 3mg/kg IV every 2 weeks~Nivolumab"
11379550|NCT02684253|BG001|Baseline|Stereotactic Body Radiotherapy & Nivolumab|"Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).~Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.~Nivolumab~Stereotactic Body Radiation Therapy (SBRT)"
11379551|NCT02684253|BG002|Baseline|Total|Total of all reporting groups
11379552|NCT02684253|FG000|Participant Flow|Nivolumab 3mg/kg IV Every 2 Weeks|"Nivolumab 3mg/kg IV every 2 weeks~Nivolumab"
10781004|NCT02738255|OG000|Outcome|Polysomnogram With Varnum Mouthpiece|Median peak flow from the night with Varnum mouthpiece
11193634|NCT02146482|FG000|Participant Flow|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
11193635|NCT02146482|FG001|Participant Flow|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
11193636|NCT02146482|OG000|Outcome|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
11193637|NCT02146482|OG001|Outcome|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
11379553|NCT02684253|FG001|Participant Flow|Stereotactic Body Radiotherapy & Nivolumab|"Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).~Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.~Nivolumab~Stereotactic Body Radiation Therapy (SBRT)"
11379554|NCT02684253|OG000|Outcome|Nivolumab 3mg/kg IV Every 2 Weeks|Nivolumab 3mg/kg IV every 2 weeks
11193638|NCT02146482|EG000|Reported Event|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
11193639|NCT02146482|EG001|Reported Event|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
11379555|NCT02684253|OG001|Outcome|Stereotactic Body Radiotherapy & Nivolumab|"Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).~Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.~Nivolumab~Stereotactic Body Radiation Therapy (SBRT)"
11379556|NCT02684253|EG000|Reported Event|Nivolumab 3mg/kg IV Every 2 Weeks|"Nivolumab 3mg/kg IV every 2 weeks~Nivolumab"
11379557|NCT02684253|EG001|Reported Event|Stereotactic Body Radiotherapy & Nivolumab|"Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).~Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.~Nivolumab~Stereotactic Body Radiation Therapy (SBRT)"
11379558|NCT02681406|BG000|Baseline|Treatment as Usual|Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
11379559|NCT02681406|BG001|Baseline|Telephone Monitoring and Counseling|"TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.~TMC: Brief telephone monitoring and counseling"
11379560|NCT02681406|BG002|Baseline|ACHESS|"Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.~ACHESS: Smartphone based additions focused application, encouraging social support"
10781005|NCT02738255|OG001|Outcome|Regular Polysomnogram|Median peak flow from the night without Varnum mouthpiece
10781006|NCT02738255|OG000|Outcome|Polysomnogram With Varnum Mouthpiece|Number of snores per hour on the night with Varnum mouthpiece
10781007|NCT02738255|OG001|Outcome|Regular Polysomnogram|Number of snores per hour on the night without Varnum
10781008|NCT02738255|EG000|Reported Event|Polysomnogram With Varnum Mouthpiece|Varnum mouthpiece, similar to a mouth tape with central opening
10781009|NCT02738255|EG001|Reported Event|Regular Polysomnogram|Overnight sleep study without Varnum mouthpiece
10781010|NCT02702414|BG000|Baseline|Cohort 1: HCC-Prior Systemic Therapy With Sorafenib|Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
10781011|NCT02702414|BG001|Baseline|Cohort 2: HCC-Systemic Therapy Naïve|Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
11193640|NCT02146599|BG000|Baseline|Pseudophakic|".~Administration of patient self assessment"
11193641|NCT02146599|FG000|Participant Flow|Pseudophakic|".~Administration of patient self assessment"
11193642|NCT02146599|OG000|Outcome|Pseudophakic|".~Administration of patient self assessment"
11193643|NCT02146599|EG000|Reported Event|Pseudophakic|".~Administration of patient self assessment"
11193644|NCT02146833|BG000|Baseline|Arm 1: Selinexor|Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
11193645|NCT02146833|FG000|Participant Flow|Arm 1: Selinexor|Participants received a dose of 80 milligrams (mg) selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
10781012|NCT02702414|BG002|Baseline|Total|Total of all reporting groups
10781013|NCT02702414|FG000|Participant Flow|Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib|Participants with previously systemically treated HCC received a pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
10781014|NCT02702414|FG001|Participant Flow|Cohort 2: HCC-Systemic Therapy Naïve|Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
10781015|NCT02702414|OG000|Outcome|Cohort 1: HCC-Prior Systemic Therapy With Sorafenib|Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
11193646|NCT02146833|OG000|Outcome|Arm 1: Selinexor|Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
10781016|NCT02702414|OG001|Outcome|Cohort 2: HCC-Systemic Therapy Naïve|Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
11193647|NCT02146833|EG000|Reported Event|Arm 1: Selinexor|Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
11193648|NCT02147067|BG000|Baseline|Ranolazine|Participants receiving 500mg twice a day for 2 weeks then 1000mg twice daily of ranolazine for 10 weeks
11193649|NCT02147067|BG001|Baseline|Placebo|Participants receiving a placebo to match the ranolazine dose for 12 weeks
11193650|NCT02147067|BG002|Baseline|Total|Total of all reporting groups
11193651|NCT02147067|FG000|Participant Flow|Ranolazine|Participants receiving 500mg twice a day for 2 weeks then 1000mg twice daily of ranolazine for 10 weeks
11193652|NCT02147067|FG001|Participant Flow|Placebo|Participants receiving a placebo to match the ranolazine dose for 12 weeks
11193653|NCT02147067|OG000|Outcome|Ranolazine|Participants receiving 500mg twice a day for 2 weeks then 1000mg twice daily of ranolazine for 10 weeks
11193654|NCT02147067|OG001|Outcome|Placebo|Participants receiving a placebo to match the ranolazine dose for 12 weeks
11193655|NCT02147067|EG000|Reported Event|Ranolazine|Participants receiving 500mg twice a day for 2 weeks then 1000mg twice daily of ranolazine for 10 weeks
11193656|NCT02147067|EG001|Reported Event|Placebo|Participants receiving a placebo to match the ranolazine dose for 12 weeks
11193657|NCT02147093|BG000|Baseline|Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)|All subjects that were randomized to sequence and were dispensed a study lens.
11193658|NCT02147093|BG001|Baseline|Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)|All subjects that were randomized to sequence and were dispensed a study lens.
11193659|NCT02147093|BG002|Baseline|Total|Total of all reporting groups
11193660|NCT02147093|FG000|Participant Flow|Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)|Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
10781017|NCT02702414|EG000|Reported Event|Cohort 1: HCC-Prior Systemic Therapy With Sorafenib|Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
10781018|NCT02702414|EG001|Reported Event|Cohort 2: HCC-Systemic Therapy Naïve|Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
10781019|NCT02702414|EG002|Reported Event|Cohort 1: HCC-Prior Systemic Therapy With Sorafenib-Second Course|Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
10781020|NCT02702414|EG003|Reported Event|Cohort 2: HCC-Systemic Therapy Naïve-Second Course|Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations
10801475|NCT03640949|FG000|Participant Flow|Vasopressin and Methylprednisolone|"The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).~Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU)~Methylprednisolone: 40 mg methylprednisolone once"
10801476|NCT03640949|FG001|Participant Flow|Placebo|"The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl (normal saline) from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.~NaCl: Placebo"
10801477|NCT03640949|OG000|Outcome|Vasopressin and Methylprednisolone|"The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).~Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU)~Methylprednisolone: 40 mg methylprednisolone once"
10801478|NCT03640949|OG001|Outcome|Placebo|"The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl (normal saline) from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.~NaCl: Placebo"
10801479|NCT03640949|EG000|Reported Event|Vasopressin and Methylprednisolone|"The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).~Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU)~Methylprednisolone: 40 mg methylprednisolone once"
10801480|NCT03640949|EG001|Reported Event|Placebo|"The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl (normal saline) from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.~NaCl: Placebo"
10801481|NCT03615508|BG000|Baseline|10% Phenylephrine|"All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.~10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation."
10964550|NCT00878189|OG004|Outcome|PF-03084014 130 mg BID in Solid Tumor Participants|PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10801482|NCT03615508|FG000|Participant Flow|10% Phenylephrine|"All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.~10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation."
10801483|NCT03615508|OG000|Outcome|10% Phenylephrine|"All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.~10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation."
10801484|NCT03615508|EG000|Reported Event|10% Phenylephrine|"All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.~10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation."
10801485|NCT03607487|BG000|Baseline|Placebo|Placebo was administered QD over an 8 week treatment period.
10801486|NCT03607487|BG001|Baseline|INCB054707 at 30 mg|INCB054707 was administered at 30 mg QD over an 8 week treatment period.
10801487|NCT03607487|BG002|Baseline|INCB054707 at 60 mg|INCB054707 was administered at 60 mg QD over an 8 week treatment period.
10801488|NCT03607487|BG003|Baseline|INCB054707 at 90 mg|INCB054707 was administered at 90 mg QD over an 8 week treatment period.
10801489|NCT03607487|BG004|Baseline|Total|Total of all reporting groups
10801490|NCT03607487|FG000|Participant Flow|Placebo|Placebo was administered QD over an 8 week treatment period.
10964551|NCT00878189|OG005|Outcome|PF-03084014 150 mg BID in Solid Tumor Participants|PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11379561|NCT02681406|BG003|Baseline|TMC + ACHESS|"Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.~ACHESS: Smartphone based additions focused application, encouraging social support~TMC: Brief telephone monitoring and counseling"
10781021|NCT02605616|BG000|Baseline|Active Drug AZ Compound|"AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~AZ compound: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781022|NCT02605616|BG001|Baseline|Placebo|"Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~Placebo: Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781023|NCT02605616|BG002|Baseline|Total|Total of all reporting groups
10781024|NCT02605616|FG000|Participant Flow|Active Drug AZ Compound|"AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~AZ compound: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781025|NCT02605616|FG001|Participant Flow|Placebo|"Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~Placebo: Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781026|NCT02605616|OG000|Outcome|Active Drug AZ Compound|"AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~AZ compound: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781027|NCT02605616|OG001|Outcome|Placebo|"Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~Placebo: Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781028|NCT02605616|EG000|Reported Event|Active Drug AZ Compound|"AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~AZ compound: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781029|NCT02605616|EG001|Reported Event|Placebo|"Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).~Placebo: Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg)."
10781030|NCT02573233|BG000|Baseline|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781031|NCT02573233|BG001|Baseline|Dupilumab|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781032|NCT02573233|BG002|Baseline|Total|Total of all reporting groups
10781033|NCT02573233|FG000|Participant Flow|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781034|NCT02573233|FG001|Participant Flow|Dupilumab|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781035|NCT02573233|OG000|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781036|NCT02573233|OG001|Outcome|Dupilumab|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781037|NCT02573233|OG000|Outcome|Dupilumab|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781038|NCT02573233|EG000|Reported Event|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781039|NCT02573233|EG001|Reported Event|Dupilumab|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10781040|NCT02425904|BG000|Baseline|Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine|"Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781041|NCT02425904|BG001|Baseline|LCH-related Disorders + Clofarabine|"Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781042|NCT02425904|BG002|Baseline|Total|Total of all reporting groups
10781043|NCT02425904|FG000|Participant Flow|Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine|"Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781044|NCT02425904|FG001|Participant Flow|LCH-related Disorders + Clofarabine|"Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781045|NCT02425904|OG000|Outcome|Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine|"Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781046|NCT02425904|OG000|Outcome|LCH-related Disorders + Clofarabine|"Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781047|NCT02425904|OG001|Outcome|LCH-related Disorders + Clofarabine|"Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles."
10781048|NCT02425904|EG000|Reported Event|Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine|"Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.~Clofarabine: second-generation purine nucleoside analog"
10781049|NCT02425904|EG001|Reported Event|LCH-related Disorders + Clofarabine|"Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.~Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.~Clofarabine: second-generation purine nucleoside analog"
10781050|NCT02420795|BG000|Baseline|ONC201 125 mg|Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781051|NCT02420795|BG001|Baseline|ONC201 250 mg|Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781052|NCT02420795|BG002|Baseline|ONC201 625 mg|Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781053|NCT02420795|BG003|Baseline|Total|Total of all reporting groups
10781054|NCT02420795|FG000|Participant Flow|ONC201 125 mg|Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781055|NCT02420795|FG001|Participant Flow|ONC201 250 mg|Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781056|NCT02420795|FG002|Participant Flow|ONC201 625 mg|Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781057|NCT02420795|OG000|Outcome|ONC201 125 mg|Patients receive Akt/ERK inhibitor ONC201 125 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781058|NCT02420795|OG000|Outcome|ONC201 125 mg|Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781059|NCT02420795|OG001|Outcome|ONC201 250 mg|Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781060|NCT02420795|OG002|Outcome|ONC201 625 mg|Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781061|NCT02420795|OG000|Outcome|ONC201 625 mg|Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781062|NCT02420795|EG000|Reported Event|ONC201 125 mg|Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781063|NCT02420795|EG001|Reported Event|ONC201 250 mg|Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10801491|NCT03607487|FG001|Participant Flow|INCB054707 at 30 mg|INCB054707 was administered at 30 mg QD over an 8 week treatment period.
11379562|NCT02681406|BG004|Baseline|Total|Total of all reporting groups
11193661|NCT02147093|FG001|Participant Flow|Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)|Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
11193662|NCT02147093|OG000|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
10781064|NCT02420795|EG002|Reported Event|ONC201 625 mg|Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10781065|NCT02240485|BG000|Baseline|Integrative Couple Treatment for Pathological Gambling|"Already described in the Intervention Description section~Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10781066|NCT02240485|BG001|Baseline|Usual Individual/Group Treatment|"Well described in the Intervention section~Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired."
10781067|NCT02240485|BG002|Baseline|Total|Total of all reporting groups
10781068|NCT02240485|FG000|Participant Flow|Integrative Couple Treatment for Pathological Gambling (ICT-PG)|"Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10781069|NCT02240485|FG001|Participant Flow|Usual Individual/Group Treatment|Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired.
10781070|NCT02240485|OG000|Outcome|Integrative Couple Treatment for Pathological Gambling (ICT-PG)|"Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
11193663|NCT02147093|OG001|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
11193664|NCT02147093|EG000|Reported Event|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
11193665|NCT02147093|EG001|Reported Event|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
11193666|NCT02147132|BG000|Baseline|All Participants|All participants randomized in this crossover trial (each randomized participant was intended to receive each medication)
11193667|NCT02147132|FG000|Participant Flow|Order 1|"Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).~Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.~Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.~Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.~Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo."
10781071|NCT02240485|OG001|Outcome|Usual Individual/Group Treatment|Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired.
10781072|NCT02240485|OG000|Outcome|Integrative Couple Treatment for Pathological Gambling (ICT-PG)|"Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10781073|NCT02240485|OG000|Outcome|Couple Treatment for Pathological Gambling|"Already described in the Intervention Description section~Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10801492|NCT03607487|FG002|Participant Flow|INCB054707 at 60 mg|INCB054707 was administered at 60 mg QD over an 8 week treatment period.
10801493|NCT03607487|FG003|Participant Flow|INCB054707 at 90 mg|INCB054707 was administered at 90 mg QD over an 8 week treatment period.
11240975|NCT02483572|BG001|Baseline|Waitlist-Control Condition|Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).
11379563|NCT02681406|FG000|Participant Flow|Treatment as Usual|Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
11379564|NCT02681406|FG001|Participant Flow|Telephone Monitoring and Counseling|"TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.~TMC: Brief telephone monitoring and counseling"
11379565|NCT02681406|FG002|Participant Flow|ACHESS|"Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.~ACHESS: Smartphone based additions focused application, encouraging social support"
11379566|NCT02681406|FG003|Participant Flow|TMC + ACHESS|"Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.~ACHESS: Smartphone based additions focused application, encouraging social support~TMC: Brief telephone monitoring and counseling"
11379567|NCT02681406|OG000|Outcome|Treatment as Usual|Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
11379568|NCT02681406|OG001|Outcome|Telephone Monitoring and Counseling|"TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.~TMC: Brief telephone monitoring and counseling"
11379569|NCT02681406|OG002|Outcome|ACHESS|"Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.~ACHESS: Smartphone based additions focused application, encouraging social support"
11379570|NCT02681406|OG003|Outcome|TMC + ACHESS|"Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.~ACHESS: Smartphone based additions focused application, encouraging social support~TMC: Brief telephone monitoring and counseling"
11379571|NCT02681406|EG000|Reported Event|Treatment as Usual|Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
11379572|NCT02681406|EG001|Reported Event|Telephone Monitoring and Counseling|"TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.~TMC: Brief telephone monitoring and counseling"
11379573|NCT02681406|EG002|Reported Event|ACHESS|"Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.~ACHESS: Smartphone based additions focused application, encouraging social support"
11379574|NCT02681406|EG003|Reported Event|TMC + ACHESS|"Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.~ACHESS: Smartphone based additions focused application, encouraging social support~TMC: Brief telephone monitoring and counseling"
11379575|NCT02625090|BG000|Baseline|UCB0942|All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg twice daily [bid]), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.
11379576|NCT02625090|FG000|Participant Flow|UCB0942|All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 milligrams (mg) (50 mg twice daily [bid]), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.
11379577|NCT02625090|OG000|Outcome|UCB0942 (SS)|All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
11379578|NCT02625090|OG000|Outcome|UCB0942 (FAS)|All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the FAS.
11379579|NCT02625090|EG000|Reported Event|UCB0942 (SS)|All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
11240976|NCT02483572|BG002|Baseline|Total|Total of all reporting groups
10801494|NCT03607487|OG000|Outcome|INCB54707|INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis.
10781074|NCT02240485|OG001|Outcome|Usual Individual/Group Treatment|"Well described in the Intervention section~Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired."
10781075|NCT02240485|OG000|Outcome|Integrative Couple Treatment for Pathological Gambling|"Already described in the Intervention Description section~Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10781076|NCT02240485|EG000|Reported Event|Integrative Couple Treatment for Pathological Gambling (ICT-PG)|"Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
10781077|NCT02240485|EG001|Reported Event|Usual Individual/Group Treatment|Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired.
10781078|NCT02227147|BG000|Baseline|rhNGF 20 µg/ml|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~rhNGF 20µg/ml"
10781079|NCT02227147|BG001|Baseline|Vehicle|"vehicle, formulation containing anti-oxidant~Placebo Vehicle"
10781080|NCT02227147|BG002|Baseline|Total|Total of all reporting groups
10781081|NCT02227147|FG000|Participant Flow|rhNGF 20 µg/ml|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~rhNGF 20µg/ml"
10781082|NCT02227147|FG001|Participant Flow|Vehicle|"vehicle, formulation containing anti-oxidant~Placebo Vehicle"
10781083|NCT02227147|OG000|Outcome|rhNGF 20 µg/ml|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~rhNGF 20µg/ml"
10781084|NCT02227147|OG001|Outcome|Vehicle|"vehicle, formulation containing anti-oxidant~Placebo Vehicle"
10781085|NCT02227147|OG001|Outcome|Placebo|"Vehicle: formulation containing anti-oxidant~Placebo: Formulation containing antioxidant"
10781086|NCT02227147|EG000|Reported Event|rhNGF 20 µg/ml - Controlled Treatment Period|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~rhNGF 20µg/ml"
10781087|NCT02227147|EG001|Reported Event|Vehicle - Controlled Treatment Period|"vehicle, formulation containing anti-oxidant~Placebo Vehicle"
10781088|NCT02227147|EG002|Reported Event|rhNGF 20 µg/ml - Follow-up Period|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~rhNGF 20µg/ml"
10781089|NCT02227147|EG003|Reported Event|Vehicle - Follow-up Period|"vehicle, formulation containing anti-oxidant~Placebo Vehicle"
10781090|NCT02227147|EG004|Reported Event|Uncontrolled Treatment Period|"rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant~Patients randomized to vehicle at baseline and not completely healed at week 8 who entered a 8-week treatment period before entering follow-up period"
10781091|NCT02199691|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10781092|NCT02199691|BG001|Baseline|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
10781093|NCT02199691|BG002|Baseline|Group 3: MenACYW Conjugate Vaccine+Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781094|NCT02199691|BG003|Baseline|Group 4: Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781095|NCT02199691|BG004|Baseline|Total|Total of all reporting groups
10781096|NCT02199691|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
10781097|NCT02199691|FG001|Participant Flow|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
10781098|NCT02199691|FG002|Participant Flow|Group 3: MenACYW Conjugate Vaccine+Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV) on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781099|NCT02199691|FG003|Participant Flow|Group 4: Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781100|NCT02199691|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10781101|NCT02199691|OG001|Outcome|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
10801495|NCT03607487|OG000|Outcome|Placebo|Placebo was administered QD over an 8 week treatment period.
11379580|NCT02539225|BG000|Baseline|Ramucirumab + S-1 + Oxaliplatin|"Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379581|NCT02539225|BG001|Baseline|Placebo + S-1 + Oxaliplatin|"Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379582|NCT02539225|BG002|Baseline|Total|Total of all reporting groups
11379583|NCT02539225|FG000|Participant Flow|Ramucirumab + S-1 + Oxaliplatin|"Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379584|NCT02539225|FG001|Participant Flow|Placebo + S-1 + Oxaliplatin|"Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379585|NCT02539225|OG000|Outcome|Ramucirumab + S-1 + Oxaliplatin|"Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379586|NCT02539225|OG001|Outcome|Placebo + S-1 + Oxaliplatin|"Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.~Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met."
11379587|NCT02539225|OG000|Outcome|Ramucirumab + S-1 + Oxaliplatin - Part A|Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
11379588|NCT02539225|OG000|Outcome|Ramucirumab + S-1 + Oxaliplatin Part B|Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
11379589|NCT02539225|OG001|Outcome|Placebo + S-1 + Oxaliplatin - Part B|Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
11379590|NCT02539225|EG000|Reported Event|Ramucirumab + S-1 + Oxaliplatin - Part A|Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
11379591|NCT02539225|EG001|Reported Event|Placebo + S-1 + Oxaliplatin - Part A|Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
11379592|NCT02539225|EG002|Reported Event|Ramucirumab + S-1 + Oxaliplatin Part B|Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
11379593|NCT02539225|EG003|Reported Event|Placebo + S-1 + Oxaliplatin - Part B|Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
10781102|NCT02199691|OG001|Outcome|Group 3: MenACYW Conjugate Vaccine+Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10801496|NCT03607487|OG001|Outcome|INCB054707 at 30 mg|INCB054707 was administered at 30 mg QD over an 8 week treatment period.
10801497|NCT03607487|OG002|Outcome|INCB054707 at 60 mg|INCB054707 was administered at 60 mg QD over an 8 week treatment period.
10781103|NCT02199691|OG000|Outcome|Group 3: MenACYW Conjugate Vaccine+Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781104|NCT02199691|OG001|Outcome|Group 4: Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781105|NCT02199691|OG000|Outcome|Group 4: Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781106|NCT02199691|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10781107|NCT02199691|EG001|Reported Event|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
10781108|NCT02199691|EG002|Reported Event|Group 3: MenACYW Conjugate Vaccine+Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781109|NCT02199691|EG003|Reported Event|Group 4: Tdap+HPV|Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
10781119|NCT02143726|BG000|Baseline|Arm 1 (Sorafenib)|Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781120|NCT02143726|BG001|Baseline|Arm 2 (Sorafenib and Everolimus)|Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781121|NCT02143726|BG002|Baseline|Total|Total of all reporting groups
10801498|NCT03607487|OG003|Outcome|INCB054707 at 90 mg|INCB054707 was administered at 90 mg QD over an 8 week treatment period.
10801499|NCT03607487|EG000|Reported Event|Placebo|Placebo was administered QD over an 8 week treatment period.
10801500|NCT03607487|EG001|Reported Event|INCB054707 at 30 mg|INCB054707 was administered at 30 mg QD over an 8 week treatment period.
10801501|NCT03607487|EG002|Reported Event|INCB054707 at 60 mg|INCB054707 was administered at 60 mg QD over an 8 week treatment period.
10801502|NCT03607487|EG003|Reported Event|INCB054707 at 90 mg|INCB054707 was administered at 90 mg QD over an 8 week treatment period.
10801503|NCT03607487|EG004|Reported Event|Total|Total
10801504|NCT03586687|BG000|Baseline|20 mg|"20mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801505|NCT03586687|BG001|Baseline|40 mg|"40mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801506|NCT03586687|BG002|Baseline|80 mg|"80mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801507|NCT03586687|BG003|Baseline|Total|Total of all reporting groups
10801508|NCT03586687|FG000|Participant Flow|20 mg Triamcinolone With 3cc of 1% Lidocaine|"20mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801509|NCT03586687|FG001|Participant Flow|40 mg Triamcinolone With 3cc of 1% Lidocaine|"40mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801510|NCT03586687|FG002|Participant Flow|80 mg Triamcinolone With 3cc of 1% Lidocaine|"80mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801511|NCT03586687|OG000|Outcome|20 mg Triamcinolone With 3cc of 1% Lidocaine|"20mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801512|NCT03586687|OG001|Outcome|40 mg Triamcinolone With 3cc of 1% Lidocaine|"40mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801513|NCT03586687|OG002|Outcome|80 mg Triamcinolone With 3cc of 1% Lidocaine|"80mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801514|NCT03586687|EG000|Reported Event|20 mg|"20mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801515|NCT03586687|EG001|Reported Event|40 mg|"40mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801516|NCT03586687|EG002|Reported Event|80 mg|"80mg Triamcinolone with 3cc of 1% Lidocaine~Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection"
10801517|NCT03529773|BG000|Baseline|Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801518|NCT03529773|BG001|Baseline|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801519|NCT03529773|BG002|Baseline|Sentinel Cohort: RSV 120 mcg Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801520|NCT03529773|BG003|Baseline|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10781122|NCT02143726|FG000|Participant Flow|Arm 1 (Sorafenib)|Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781123|NCT02143726|FG001|Participant Flow|Arm 2 (Sorafenib and Everolimus)|Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781124|NCT02143726|OG000|Outcome|Arm 1 (Sorafenib)|Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781125|NCT02143726|OG001|Outcome|Arm 2 (Sorafenib and Everolimus)|Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781126|NCT02143726|EG000|Reported Event|Arm 1 (Sorafenib)|Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781127|NCT02143726|EG001|Reported Event|Arm 2 (Sorafenib and Everolimus)|Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10781128|NCT02046512|BG000|Baseline|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis~Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
10781129|NCT02046512|BG001|Baseline|Sugar Pill|"Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis~Placebo: Sugar pill"
10781130|NCT02046512|BG002|Baseline|Total|Total of all reporting groups
10781131|NCT02046512|FG000|Participant Flow|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis~Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
10781132|NCT02046512|FG001|Participant Flow|Sugar Pill|"Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis~Placebo: Sugar pill"
10781133|NCT02046512|OG000|Outcome|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis~Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
11339839|NCT03639766|BG000|Baseline|All Study Participants|"All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand.~The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline.~The saline injection consisted of 10 ml of non-bacteriostatic normal saline."
10781134|NCT02046512|OG001|Outcome|Sugar Pill|"Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis~Placebo: Sugar pill"
10781135|NCT02046512|EG000|Reported Event|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis~Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
10781136|NCT02046512|EG001|Reported Event|Sugar Pill|"Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis~Placebo: Sugar pill"
10781137|NCT01958593|BG000|Baseline|Comparator|"Participants will receive placebo during each of two experimental sessions.~Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment~Psychotherapy: Psychotherapy before and after experimental sessions"
10781138|NCT01958593|BG001|Baseline|3,4-methylenedioxymethamphetamine|"Participants will receive full-dose MDMA during each of two experimental sessions.~3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.~Psychotherapy: Psychotherapy before and after experimental sessions"
10781139|NCT01958593|BG002|Baseline|Total|Total of all reporting groups
10781140|NCT01958593|FG000|Participant Flow|Comparator|"Participants will receive placebo during each of two experimental sessions.~Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment~Psychotherapy: Psychotherapy before and after experimental sessions"
10781141|NCT01958593|FG001|Participant Flow|3,4-methylenedioxymethamphetamine|"Participants will receive full-dose MDMA during each of two experimental sessions.~3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.~Psychotherapy: Psychotherapy before and after experimental sessions"
10781142|NCT01958593|OG000|Outcome|Comparator|"Participants will receive placebo during each of two experimental sessions.~Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment~Psychotherapy: Psychotherapy before and after experimental sessions"
10781143|NCT01958593|OG001|Outcome|3,4-methylenedioxymethamphetamine|"Participants will receive full-dose MDMA during each of two experimental sessions.~3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.~Psychotherapy: Psychotherapy before and after experimental sessions"
10801521|NCT03529773|BG004|Baseline|Sentinel Cohort: RSV 240 mcg Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
11379594|NCT02528500|BG000|Baseline|TAMBE Device|"Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.~GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)"
11379595|NCT02528500|FG000|Participant Flow|TAMBE Device|"Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.~GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)"
11379596|NCT02528500|OG000|Outcome|TAMBE Device|"Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.~GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)"
11379597|NCT02528500|EG000|Reported Event|TAMBE Device|"Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.~GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)"
11379598|NCT02527681|BG000|Baseline|Ceftobiprole ITT/Safety Population|All subjects who received any quantity of study drug.
11379599|NCT02527681|FG000|Participant Flow|Ceftobiprole ITT/Safety Population|All subjects who received any quantity of study drug.
11379600|NCT02527681|OG000|Outcome|Ceftobiprole PK Population|All subjects who received study drug and had adequate samples for determination of time-plasma concentration profiles of ceftobiprole.
11379601|NCT02527681|EG000|Reported Event|Ceftobiprole ITT/Safety Population|All subjects who received any quantity of study drug.
11379602|NCT02526017|BG000|Baseline|Phase 1a: Cabiralizumab 2 mg/kg|Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379603|NCT02526017|BG001|Baseline|Phase 1a: Cabiralizumab 4 mg/kg|Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379604|NCT02526017|BG002|Baseline|Phase 1a: Cabiralizumab 6 mg/kg|Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379605|NCT02526017|BG003|Baseline|Phase 1a: Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379606|NCT02526017|BG004|Baseline|Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379607|NCT02526017|BG005|Baseline|Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10781144|NCT01958593|EG000|Reported Event|Comparator (Stage 1)|"Participants will receive placebo during each of two experimental sessions.~Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment~Psychotherapy: Psychotherapy before and after experimental sessions"
10781145|NCT01958593|EG001|Reported Event|3,4-methylenedioxymethamphetamine (Stage 1)|"Participants will receive full-dose MDMA during each of two experimental sessions.~3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.~Psychotherapy: Psychotherapy before and after experimental sessions"
11379608|NCT02526017|BG006|Baseline|Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379609|NCT02526017|BG007|Baseline|Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379610|NCT02526017|BG008|Baseline|Phase 1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379611|NCT02526017|BG009|Baseline|Total|Total of all reporting groups
11379612|NCT02526017|FG000|Participant Flow|Phase 1a: Cabiralizumab 2 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379613|NCT02526017|FG001|Participant Flow|Phase 1a: Cabiralizumab 4 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10781146|NCT01958593|EG002|Reported Event|3,4-methylenedioxymethamphetamine (Stage 2)|"Participants will receive full-dose MDMA during each of two experimental sessions.~3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.~Psychotherapy: Psychotherapy before and after experimental sessions"
10781147|NCT01842035|BG000|Baseline|Regadenoson|"Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.~--------------------------------------------------------------------------------~regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline."
10781148|NCT01842035|FG000|Participant Flow|Regadenoson|"Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.~--------------------------------------------------------------------------------~regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline."
10781149|NCT01842035|OG000|Outcome|Heart Rate Response Greater Than Median|Heart rate response >= 24%
10781150|NCT01842035|OG001|Outcome|Heart Rate Response Less Than Median|Heart rate response < 24%
10781151|NCT01842035|EG000|Reported Event|Regadenoson|"Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.~--------------------------------------------------------------------------------~regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline."
10781152|NCT01751984|BG000|Baseline|ETC-1002|Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
11379614|NCT02526017|FG002|Participant Flow|Phase 1a: Cabiralizumab 6 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10781153|NCT01751984|BG001|Baseline|Placebo|Participants received placebo QD on Day 1 for 8 weeks.
10781154|NCT01751984|BG002|Baseline|Total|Total of all reporting groups
10781155|NCT01751984|FG000|Participant Flow|ETC-1002|Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
10781156|NCT01751984|FG001|Participant Flow|Placebo|Participants received placebo QD on Day 1 for 8 weeks.
10781157|NCT01751984|OG000|Outcome|ETC-1002|Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
10781158|NCT01751984|OG001|Outcome|Placebo|Participants received placebo QD on Day 1 for 8 weeks.
10781159|NCT01751984|EG000|Reported Event|ETC-1002|Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
10781160|NCT01751984|EG001|Reported Event|Placebo|Participants received placebo QD on Day 1 for 8 weeks.
10781161|NCT01732627|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10781162|NCT01732627|BG001|Baseline|Group 2: Menomune® A/C/Y/W 135 Vaccine|Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
10781163|NCT01732627|BG002|Baseline|Total|Total of all reporting groups
10781164|NCT01732627|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
10781165|NCT01732627|FG001|Participant Flow|Group 2: Menomune® A/C/Y/W 135 Vaccine|Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.
10781166|NCT01732627|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10781167|NCT01732627|OG001|Outcome|Group 2: Menomune® A/C/Y/W 135 Vaccine|Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
11379615|NCT02526017|FG003|Participant Flow|Phase 1a: Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379616|NCT02526017|FG004|Participant Flow|Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379617|NCT02526017|FG005|Participant Flow|Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379618|NCT02526017|FG006|Participant Flow|Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379619|NCT02526017|FG007|Participant Flow|Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379620|NCT02526017|FG008|Participant Flow|Phase 1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379621|NCT02526017|OG000|Outcome|Cabiralizumab 2 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W).
11379622|NCT02526017|OG001|Outcome|Cabiralizumab 4 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV Q2W
11379623|NCT02526017|OG002|Outcome|Cabiralizumab 6 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV Q2W.
11379624|NCT02526017|OG003|Outcome|Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
11379625|NCT02526017|OG004|Outcome|Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
11379626|NCT02526017|OG005|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
11379627|NCT02526017|OG006|Outcome|Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
11379628|NCT02526017|OG000|Outcome|Overall Phase 1a Dose Escalation|Participants received escalating doses of cabiralizumab monotherapy or cabiralizumab in combination with nivolumab.
10781168|NCT01732627|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
11379629|NCT02526017|OG000|Outcome|Cabiralizumab 2 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379630|NCT02526017|OG001|Outcome|Cabiralizumab 4 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379631|NCT02526017|OG002|Outcome|Cabiralizumab 6 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379632|NCT02526017|OG003|Outcome|Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379633|NCT02526017|OG004|Outcome|Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379634|NCT02526017|OG005|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379635|NCT02526017|OG006|Outcome|Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379636|NCT02526017|OG007|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379637|NCT02526017|OG000|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379638|NCT02526017|OG000|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)|Participants with non-small cell lung cancer (NSCLC) with no prior exposure to any programmed cell death 1 (PD-1) pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379639|NCT02526017|OG001|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)|Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379640|NCT02526017|OG002|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN|Participants with squamous cell carcinoma of the head and neck (SCCHN) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379641|NCT02526017|OG003|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer|Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379642|NCT02526017|OG004|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer|Participants with advanced ovarian cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10781169|NCT01732627|EG001|Reported Event|Group 2: Menomune® A/C/Y/W 135 Vaccine|Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
10781170|NCT01702571|BG000|Baseline|Trastuzumab Emtansine (All Participants)|This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781171|NCT01702571|BG001|Baseline|Trastuzumab Emtansine (Asian Participants)|This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781172|NCT01702571|BG002|Baseline|Total|Total of all reporting groups
10781173|NCT01702571|FG000|Participant Flow|Trastuzumab Emtansine (All Participants)|This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
11243308|NCT02502149|BG000|Baseline|2K/15K rFVIIIFc (1000/6000 IU/Vial Strength)- All Participants|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for PK1. At PK1, participants were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
10781174|NCT01702571|FG001|Participant Flow|Trastuzumab Emtansine (Asian Participants)|This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781175|NCT01702571|OG000|Outcome|Trastuzumab Emtansine (All Participants)|This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781176|NCT01702571|OG001|Outcome|Trastuzumab Emtansine (Asian Participants)|This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781177|NCT01702571|EG000|Reported Event|Trastuzumab Emtansine (All Participants)|This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781178|NCT01702571|EG001|Reported Event|Trastuzumab Emtansine (Asian Participants)|This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
10781179|NCT01578239|BG000|Baseline|177Lu-DOTA0-Tyr3-Octreotate|"30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.~Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).~Concomitant amino acids were given with each administration for kidney protection.~177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed."
10781180|NCT01578239|BG001|Baseline|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed."
10781181|NCT01578239|BG002|Baseline|Total|Total of all reporting groups
10781182|NCT01578239|FG000|Participant Flow|177Lu-DOTA0-Tyr3-Octreotate|"30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.~Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).~Concomitant amino acids were given with each administration for kidney protection.~177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed."
10781183|NCT01578239|FG001|Participant Flow|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed."
11379643|NCT02526017|OG005|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC|Participants with renal cell carcinoma (RCC) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379644|NCT02526017|OG006|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Malignant Glioma|Participants with malignant glioma (GBM) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379645|NCT02526017|OG007|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma|Participants with melanoma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379646|NCT02526017|OG000|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)|Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379647|NCT02526017|OG002|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN|Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379648|NCT02526017|OG005|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC|Participants with RCC received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379649|NCT02526017|OG006|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM|Participants with malignant glioma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379650|NCT02526017|OG000|Outcome|Cabiralizumab 2 mg/kg Q2W|Participants with any solid tumor received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379651|NCT02526017|OG001|Outcome|Cabiralizumab 4 mg/kg Q2W|Participants with any solid tumor received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379652|NCT02526017|OG002|Outcome|Cabiralizumab 6 mg/kg Q2W|Participants with any solid tumor received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379653|NCT02526017|OG003|Outcome|Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W|Participants with any solid tumor received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379654|NCT02526017|OG004|Outcome|Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants with any solid tumor received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379655|NCT02526017|OG005|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379656|NCT02526017|OG006|Outcome|Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants with any solid tumor received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379657|NCT02526017|OG007|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants with any solid tumor received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q3W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379658|NCT02526017|OG008|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)|Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379659|NCT02526017|OG009|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)|Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10801522|NCT03529773|BG005|Baseline|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
11379660|NCT02526017|OG010|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN|Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379661|NCT02526017|OG011|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer|Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379662|NCT02526017|OG012|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer|Participants with advanced ovarian cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379663|NCT02526017|OG013|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC|Participants with RCC received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379664|NCT02526017|OG014|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM|Participants with malignant glioma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379665|NCT02526017|OG015|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma|Participants with melanoma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
10801523|NCT03529773|BG006|Baseline|Sentinel Cohort: Placebo Age 18-49 Years|Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
11379666|NCT02526017|OG000|Outcome|Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379667|NCT02526017|OG001|Outcome|Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379668|NCT02526017|OG002|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379669|NCT02526017|OG003|Outcome|Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379670|NCT02526017|OG004|Outcome|Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379671|NCT02526017|EG000|Reported Event|Phase 1a: Cabiralizumab 2 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379672|NCT02526017|EG001|Reported Event|Phase 1a: Cabiralizumab 4 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379673|NCT02526017|EG002|Reported Event|Phase 1a: Cabiralizumab 6 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379674|NCT02526017|EG003|Reported Event|Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379675|NCT02526017|EG004|Reported Event|Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379676|NCT02526017|EG005|Reported Event|Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379677|NCT02526017|EG006|Reported Event|Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W|Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379678|NCT02526017|EG007|Reported Event|Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W|Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
11379679|NCT02482233|BG000|Baseline|Nicotine Replacement Therapy (NRT)|As described above
11379680|NCT02482233|BG001|Baseline|Electronic Cigarette (END)|As described above
11379681|NCT02482233|BG002|Baseline|Total|Total of all reporting groups
11379682|NCT02482233|FG000|Participant Flow|Nicotine Replacement Patch Group (Control)|Patients randomized to the NRT group received a 6-week supply of NicodermCQ patches (5 weeks) and placebo patches (1 week) appropriate to baseline nicotine consumption.
11379683|NCT02482233|FG001|Participant Flow|Electronic Cigarette (END) Group|Those allocated to the END group received a 6-week supply of NJOY e-cigarettes (Scottsdale, AZ, USA) and were instructed to use the Bold (4.5%) e-cigarettes ad libitum for 3 weeks, the Gold (2.4%) e-cigarettes ad libitum for 2 weeks and the Study (0%) ecigarettes ad libitum for the final week.
11379684|NCT02482233|OG000|Outcome|Nicotine Replacement Therapy (NRT)|As above
11379685|NCT02482233|OG001|Outcome|Electronic Cigarette (END)|As above
11379686|NCT02482233|OG000|Outcome|Nicotine Replacement Therapy (NRT)|as above
11379687|NCT02482233|OG001|Outcome|Electronic Cigarette (END)|as above
11379688|NCT02482233|EG000|Reported Event|Nicotine Replacement Therapy (NRT)|As above
11379689|NCT02482233|EG001|Reported Event|Electronic Cigarette (END)|As above
11379690|NCT02450331|BG000|Baseline|Observation|Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
11379691|NCT02450331|BG001|Baseline|Atezolizumab|Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
11379692|NCT02450331|BG002|Baseline|Total|Total of all reporting groups
11379693|NCT02450331|FG000|Participant Flow|Observation|Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
11379694|NCT02450331|FG001|Participant Flow|Atezolizumab|Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
11379695|NCT02450331|OG000|Outcome|Observation|Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
11379696|NCT02450331|OG001|Outcome|Atezolizumab|Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
11379697|NCT02450331|OG000|Outcome|Atezolizumab|Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
11379698|NCT02450331|EG000|Reported Event|OBSERVATION|Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
11379699|NCT02450331|EG001|Reported Event|ATEZOLIZUMAB|Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
11379700|NCT02417415|BG000|Baseline|All Study Participants|Participants who were randomized to receive local passive heat stress and sham control in any order.
11379701|NCT02417415|FG000|Participant Flow|Local Heat Stress Then Sham Control|Passive heat-stress of 40-42 degrees applied with an electric heating pad over the abdomen and part of the torso for up to 2 hours on study day 1 and sham control (heating pad turned off for up to 2 hours) on study day 2
11379702|NCT02417415|FG001|Participant Flow|Sham Control Then Local Heat Stress|Sham control (heating pad turned off for up to 2 hours) on study day 1 and local heat stress of 40-42 degrees applied with an electric heating pad over the abdomen and part of the torso for up to 2 hours on study day 2.
11379703|NCT02417415|OG000|Outcome|Local Heat Stress|"Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso~Passive heat stress: Passive heat stress was applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at 40-42 degrees continuously for 2 hr."
11379704|NCT02417415|OG001|Outcome|Control (Non-heating)|"Commercial heating pad applied over the abdomen and part of the torso but turned off~Control (non-heating): Heating pad was applied over the abdomen and part of the torso but it will be turned off for up to 2 hours"
11379705|NCT02417415|EG000|Reported Event|Local Heat Stress|"Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso~Passive heat stress: Passive heat stress was applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at 40-42 degrees continuously for 2 hr."
11379706|NCT02417415|EG001|Reported Event|Control (Non-heating)|"Commercial heating pad applied over the abdomen and part of the torso but turned off~Control (non-heating): Heating pad was applied over the abdomen and part of the torso but it will be turned off for up to 2 hours"
11379707|NCT02400736|BG000|Baseline|Individual Placement and Support (IPS)|"Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study."
11379708|NCT02400736|BG001|Baseline|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained.
11379709|NCT02400736|BG002|Baseline|Total|Total of all reporting groups
11379710|NCT02400736|FG000|Participant Flow|Individual Placement and Support (IPS)|".Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team (PACT); 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study."
11379711|NCT02400736|FG001|Participant Flow|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained.
11379712|NCT02400736|OG000|Outcome|Individual Placement and Support (IPS)|"Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study."
10801524|NCT03529773|BG007|Baseline|Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10781184|NCT01578239|OG000|Outcome|177Lu-DOTA0-Tyr3-Octreotate|"30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.~Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).~Concomitant amino acids were given with each administration for kidney protection.~177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed."
10781185|NCT01578239|OG001|Outcome|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed."
10781186|NCT01578239|EG000|Reported Event|177Lu-DOTA0-Tyr3-Octreotate|"30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.~Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).~Concomitant amino acids were given with each administration for kidney protection.~177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed."
10781187|NCT01578239|EG001|Reported Event|Octreotide LAR|"60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.~In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed."
10781188|NCT01458340|BG000|Baseline|Placebo|Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.
10781189|NCT01458340|BG001|Baseline|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.
10781190|NCT01458340|BG002|Baseline|TD-9855 20 mg|Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
10781191|NCT01458340|BG003|Baseline|Total|Total of all reporting groups
10781192|NCT01458340|FG000|Participant Flow|Placebo|Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.
10781193|NCT01458340|FG001|Participant Flow|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.
10781194|NCT01458340|FG002|Participant Flow|TD-9855 20 mg|Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
10781195|NCT01458340|OG000|Outcome|Placebo|Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.
10781196|NCT01458340|OG001|Outcome|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.
10781197|NCT01458340|OG002|Outcome|TD-9855 20 mg|Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
10781198|NCT01458340|OG000|Outcome|Placebo|Participants received matching placebo as oral capsules once per day from Day 1 to Day 42.
10781199|NCT01458340|OG001|Outcome|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules once per day from Day 1 to Day 42.
10781200|NCT01458340|OG002|Outcome|TD-9855 20 mg|Participants received 10 mg TD-9855 as oral capsules once per day from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to take the 10 mg from Day 8 to Day 42.
10781201|NCT01458340|OG001|Outcome|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.
10781202|NCT01458340|EG000|Reported Event|Placebo|Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.
10781203|NCT01458340|EG001|Reported Event|TD-9855 5mg|Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.
10781204|NCT01458340|EG002|Reported Event|TD-9855 20 mg|Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
10781205|NCT01411267|BG000|Baseline|ALL AC220 @ 25mg/m2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
10801525|NCT03529773|BG008|Baseline|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
11193668|NCT02147132|FG001|Participant Flow|Order 2|"Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).~Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.~Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.~Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.~Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo."
11193669|NCT02147132|FG002|Participant Flow|Order 3|"Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).~Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.~Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.~Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.~Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo."
11193670|NCT02147132|FG003|Participant Flow|Order 4|"Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).~Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.~Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.~Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.~Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo."
11193671|NCT02147132|OG000|Outcome|Nicotine Nasal Spray|All participants who received the nicotine nasal spray
11193672|NCT02147132|OG001|Outcome|Placebo Nasal Spray|All participants who received the placebo nasal spray
11193673|NCT02147132|OG002|Outcome|Varenicline Tablets|All participants who received the active varenicline tablets
11193674|NCT02147132|OG003|Outcome|Placebo Varenicline Tablets|All participants who received the placebo varenicline tablets
11193675|NCT02147132|EG000|Reported Event|Nicotine Nasal Spray|All participants who received the nicotine nasal spray
11193676|NCT02147132|EG001|Reported Event|Placebo Nasal Spray|All participants who received the placebo nasal spray
11193677|NCT02147132|EG002|Reported Event|Varenicline Tablets|All participants who received the active varenicline tablets
11193678|NCT02147132|EG003|Reported Event|Placebo Varenicline Tablets|All participants who received the placebo varenicline tablets
11193679|NCT02147158|BG000|Baseline|UPA 5 mg:Placebo|Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
11193680|NCT02147158|BG001|Baseline|UPA 10 mg:Placebo|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
11193681|NCT02147158|BG002|Baseline|UPA 5 mg:UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
11193682|NCT02147158|BG003|Baseline|UPA 10 mg:UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
11193683|NCT02147158|BG004|Baseline|Placebo:UPA 5 mg|Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193684|NCT02147158|BG005|Baseline|Placebo:UPA 10 mg|Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193685|NCT02147158|BG006|Baseline|Total|Total of all reporting groups
11193686|NCT02147158|FG000|Participant Flow|UPA 5 mg:Placebo|Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
11193687|NCT02147158|FG001|Participant Flow|UPA 10 mg:Placebo|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
11193688|NCT02147158|FG002|Participant Flow|UPA 5 mg:UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
11193689|NCT02147158|FG003|Participant Flow|UPA 10 mg:UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
11193690|NCT02147158|FG004|Participant Flow|Placebo:UPA 5 mg|Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193691|NCT02147158|FG005|Participant Flow|Placebo:UPA 10 mg|Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193692|NCT02147158|OG000|Outcome|Placebo|Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
11193693|NCT02147158|OG001|Outcome|UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
11193694|NCT02147158|OG002|Outcome|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
11193695|NCT02147158|OG000|Outcome|Placebo|Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
11193696|NCT02147158|OG001|Outcome|UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193697|NCT02147158|OG002|Outcome|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
11193698|NCT02147158|EG000|Reported Event|Placebo (Treatment Course 1)|Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
11193699|NCT02147158|EG001|Reported Event|UPA 5 mg (Treatment Course 1)|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
11193700|NCT02147158|EG002|Reported Event|UPA 10 mg (Treatment Course 1)|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
11193701|NCT02147158|EG003|Reported Event|UPA 5 mg:Placebo (Treatment Course 2)|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193702|NCT02147158|EG004|Reported Event|UPA 10 mg:Placebo (Treatment Course 2)|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193703|NCT02147158|EG005|Reported Event|UPA 5 mg:UPA 5 mg (Treatment Course 2)|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193704|NCT02147158|EG006|Reported Event|UPA 10 mg:UPA 10 mg (Treatment Course 2)|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193705|NCT02147158|EG007|Reported Event|Placebo:UPA 5 mg (Treatment Course 2)|Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193706|NCT02147158|EG008|Reported Event|Placebo:UPA 10 mg (Treatment Course 2)|Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
11193707|NCT02147197|BG000|Baseline|Placebo|Matching placebo tablet (5 mg and 10 mg), orally, once daily for 12 weeks.
11193708|NCT02147197|BG001|Baseline|UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
11193709|NCT02147197|BG002|Baseline|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
11193710|NCT02147197|BG003|Baseline|Total|Total of all reporting groups
11193711|NCT02147197|FG000|Participant Flow|Placebo|Matching placebo tablet (5 mg and 10 mg), orally, once daily for 12 weeks.
10801526|NCT03529773|BG009|Baseline|Sentinel Cohort: RSV 120 mcg Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
11193712|NCT02147197|FG001|Participant Flow|UPA 5 mg|Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
11193713|NCT02147197|FG002|Participant Flow|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
11193714|NCT02147197|OG000|Outcome|Placebo|Matching placebo tablet (5 mg and 10 mg), orally, once daily for 12 weeks.
11193715|NCT02147197|OG001|Outcome|UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
11193716|NCT02147197|OG002|Outcome|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
11193717|NCT02147197|EG000|Reported Event|Placebo|Matching placebo tablet (5 mg and 10 mg), orally, once daily for 12 weeks.
11193718|NCT02147197|EG001|Reported Event|UPA 5 mg|UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
11193719|NCT02147197|EG002|Reported Event|UPA 10 mg|UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
11193720|NCT02147288|BG000|Baseline|Panniculectomy on JP Drains|Standard of Care
11193721|NCT02147288|BG001|Baseline|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
11193722|NCT02147288|BG002|Baseline|Total|Total of all reporting groups
11193723|NCT02147288|FG000|Participant Flow|Panniculectomy on Jackson Pratt (JP) Drains|Standard of Care
11193724|NCT02147288|FG001|Participant Flow|Panniculectomy on Negative Pressure Wound Therapy (NPWT)|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
11193725|NCT02147288|FG002|Participant Flow|Breast Recon With Acellular Dermal Matrix (ADM) on NPWT|
11193726|NCT02147288|FG003|Participant Flow|Breast Recon With ADM on Jackson-Pratt (JP) Drains|
11379713|NCT02400736|OG001|Outcome|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained.
11379714|NCT02400736|OG000|Outcome|Individual Placement and Support (IPS)|".Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study."
11379715|NCT02400736|OG001|Outcome|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained.
11379716|NCT02400736|OG000|Outcome|Individual Placement and Support (IPS)|"Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study.~Individual Placement and Support (IPS): Individual Placement and Support (IPS) is the evidenced based model of supported employment."
11379717|NCT02400736|OG001|Outcome|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|"Treatment as Usual Vocational Rehabilitation includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained.~Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR): Vocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW)."
10781206|NCT01411267|BG001|Baseline|AML AC220 @ 25mg/m2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
10781207|NCT01411267|BG002|Baseline|ALL AC220 @ 40mg/m2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
11193727|NCT02147288|FG004|Participant Flow|Lipoabdominoplasty on NPWT|
11193728|NCT02147288|FG005|Participant Flow|Lipoabdominoplasty on JP Drains|
11193729|NCT02147288|FG006|Participant Flow|Abdominoplasty on NPWT|
11193730|NCT02147288|FG007|Participant Flow|Abdominoplasty on JP Drains|
11193731|NCT02147288|FG008|Participant Flow|Ventral Hernia Repair (VHR) on NPWT|
11193732|NCT02147288|FG009|Participant Flow|Ventral Hernia Repair (VHR) on JP Drains|
11193733|NCT02147288|OG000|Outcome|Panniculectomy on JP Drains|Standard of Care
11379718|NCT02400736|EG000|Reported Event|Individual Placement and Support (IPS)|"Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. zero exclusion; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study."
11379719|NCT02400736|EG001|Reported Event|Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)|Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained.
11379720|NCT02369653|BG000|Baseline|Apixaban|"Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase.~Weight range - Dose~>/=35 kg - 2.5 mg twice daily <35 to 25 kg - 2 mg twice daily <25 to 18 kg - 1.5 mg twice daily <18 to 10.5 kg - 1 mg twice daily <10.5 to 6 kg - 0.5 mg twice daily"
11379721|NCT02369653|BG001|Baseline|Standard of Care|No systemic anticoagulant prophylaxis during induction chemotherapy
11379722|NCT02369653|BG002|Baseline|Total|Total of all reporting groups
11379723|NCT02369653|FG000|Participant Flow|Apixaban|"Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase.~Weight range - Dose~>/=35 kg - 2.5 mg twice daily <35 to 25 kg - 2 mg twice daily <25 to 18 kg - 1.5 mg twice daily <18 to 10.5 kg - 1 mg twice daily <10.5 to 6 kg - 0.5 mg twice daily"
11379724|NCT02369653|FG001|Participant Flow|Standard of Care|No systemic anticoagulant prophylaxis during induction chemotherapy
11379725|NCT02369653|OG000|Outcome|Apixaban|"Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase.~Weight range - Dose~>/=35 kg - 2.5 mg twice daily <35 to 25 kg - 2 mg twice daily <25 to 18 kg - 1.5 mg twice daily <18 to 10.5 kg - 1 mg twice daily <10.5 to 6 kg - 0.5 mg twice daily"
11379726|NCT02369653|OG001|Outcome|Standard of Care|No systemic anticoagulant prophylaxis during induction chemotherapy
11379727|NCT02369653|OG000|Outcome|Participants Weight Range ≥ 35 kg|Participants will be administered 2.5mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
11379728|NCT02369653|OG001|Outcome|Participants Weight Range 25 to < 35 kg|Participants will be administered 2mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
11379729|NCT02369653|OG002|Outcome|Participants Weight Range 18 to < 25 kg|Participants will be administered 1.5mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
11379730|NCT02369653|OG003|Outcome|Participants Weight Range 10.5 to < 18 kg|Participants will be administered 1mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
11379731|NCT02369653|EG000|Reported Event|Apixaban|Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase
11379732|NCT02369653|EG001|Reported Event|Standard of Care|No systemic anticoagulant prophylaxis during induction chemotherapy
11379733|NCT02335424|BG000|Baseline|Pembrolizumab 200 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months
11379734|NCT02335424|FG000|Participant Flow|Pembrolizumab 200 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 24 months
10781208|NCT01411267|BG003|Baseline|AML AC220 @ 40mg/m2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age.
11379735|NCT02335424|OG000|Outcome|Pembrolizumab 200 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months
11379736|NCT02335424|EG000|Reported Event|Pembrolizumab 200 mg|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for up to 24 months
11379737|NCT02326974|BG000|Baseline|T-DM1 and Pertuzumab|T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
11379738|NCT02326974|FG000|Participant Flow|T-DM1 and Pertuzumab|T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
11379739|NCT02326974|OG000|Outcome|Heterogeneous HER2 Amplification Status|T-DM1 and Pertuzumab T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
10781209|NCT01411267|BG004|Baseline|ALL AC220 @ 60mg/m2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781210|NCT01411267|BG005|Baseline|AML AC220 @ 60mg/m2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781211|NCT01411267|BG006|Baseline|Total|Total of all reporting groups
10781212|NCT01411267|FG000|Participant Flow|ALL AC220 @ 25mg/m^2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
10781213|NCT01411267|FG001|Participant Flow|AML AC220 @ 25mg/m^2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
10781214|NCT01411267|FG002|Participant Flow|ALL AC220 @ 40mg/m^2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
10781215|NCT01411267|FG003|Participant Flow|AML AC220 @ 40mg/m^2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
10781216|NCT01411267|FG004|Participant Flow|ALL AC220 @ 60mg/m^2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781217|NCT01411267|FG005|Participant Flow|AML AC220 @ 60mg/m^2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781218|NCT01411267|FG006|Participant Flow|ALL AC220 @ 90mg/m^2/Day (Dose Level 4)|If the study dose of 60 mg/m^2/day at Dose Level 3 is well tolerated but does not show sufficient AC220 activity, the study may proceed to Dose Level 4 at 90 mg/m2/day. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 4 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781219|NCT01411267|FG007|Participant Flow|AML AC220 @ 90mg/m^2/Day (Dose Level 4)|If the study dose of 60 mg/m^2/day at Dose Level 3 is well tolerated but does not show sufficient AC220 activity, the study may proceed to Dose Level 4 at 90 mg/m^2/day. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 4 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781220|NCT01411267|FG008|Participant Flow|ALL AC220 @ 130mg/m^2/Day (Dose Level 5)|If the study dose of 90 mg/m^2/day at Dose Level 4 is well tolerated but does not show sufficient AC220 activity, the study may proceed to Dose Level 5 at 130 mg/m^2/day. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. Dose Level 5 is the highest dose for this study.
11193734|NCT02147288|OG001|Outcome|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
11193735|NCT02147288|EG000|Reported Event|Panniculectomy on JP Drains|Standard of Care
11193736|NCT02147288|EG001|Reported Event|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
10781221|NCT01411267|FG009|Participant Flow|AML AC220 @ 130mg/m^2/Day (Dose Level 5)|If the study dose of 90 mg/m^2/day at Dose Level 4 is well tolerated but does not show sufficient AC220 activity, the study may proceed to Dose Level 5 at 130 mg/m^2/day. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. Dose Level 5 is the highest dose for this study.
10781222|NCT01411267|OG000|Outcome|ALL AC220 @ 25mg/m^2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
11193737|NCT02147301|BG000|Baseline|DEB-TACE #1|"Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first~1st debtace treatment"
11379740|NCT02326974|OG001|Outcome|Non-Heterogeneous HER2 Amplification Status|T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
11379741|NCT02326974|OG000|Outcome|T-DM1 and Pertuzumab|T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
11379742|NCT02326974|OG001|Outcome|Non-Heterogeneous HER2 Amplification Status|T-DM1 and Pertuzumab T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
11379743|NCT02326974|OG000|Outcome|T-DM1 and Pertuzumab|"T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.~T-DM1: Neoadjuvant treatment is for a total of 18 weeks.~Pertuzumab: Neoadjuvant treatment is for a total of 18 weeks.~Excision of tumor/mastectomy: Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy."
11379744|NCT02326974|EG000|Reported Event|T-DM1 and Pertuzumab|"T-DM1 via IV every 3 weeks for 6 doses and Pertuzumab loading dose via IV on Cycle 1 Day 1 followed by maintenance dose via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor~T-DM1: Participants will receive Trastuzumab emtansine (T-DM1) by IV every 3 weeks for 6 doses; for a total of 18 weeks of treatment.~Pertuzumab: Participants will receive a loading dose of pertuzumab by IV on Cycle 1 Day 1 followed by maintenance dose of pertuzumab by IV every 3 weeks for a total of 6 doses; for a total of 18 weeks of treatment.~Excision of tumor/mastectomy: Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy."
11379745|NCT02284568|BG000|Baseline|Placebo|3 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379746|NCT02284568|BG001|Baseline|Laquinimod 0.6 mg|1 capsule containing 0.6 mg laquinimod and 2 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379747|NCT02284568|BG002|Baseline|Laquinimod 1.5 mg|3 capsules containing 0.5 mg laquinimod were administered orally once daily for at least 48 weeks. However this arm was discontinued as of 01 January 2016 and no participants reached the 48 week timeframe.
11379748|NCT02284568|BG003|Baseline|Total|Total of all reporting groups
11379749|NCT02284568|FG000|Participant Flow|Placebo|3 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379750|NCT02284568|FG001|Participant Flow|Laquinimod 0.6 mg|1 capsule containing 0.6 mg laquinimod and 2 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379751|NCT02284568|FG002|Participant Flow|Laquinimod 1.5 mg|3 capsules containing 0.5 mg laquinimod were administered orally once daily for at least 48 weeks. However this arm was discontinued as of 01 January 2016 and no participants reached the 48 week timeframe.
11379752|NCT02284568|OG000|Outcome|Placebo|3 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379753|NCT02284568|OG001|Outcome|Laquinimod 0.6 mg|1 capsule containing 0.6 mg laquinimod and 2 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379754|NCT02284568|OG002|Outcome|Laquinimod 1.5 mg|3 capsules containing 0.5 mg laquinimod were administered orally once daily for at least 48 weeks. However this arm was discontinued as of 01 January 2016 and no participants reached the 48 week timeframe.
11379755|NCT02284568|EG000|Reported Event|Placebo|3 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379756|NCT02284568|EG001|Reported Event|Laquinimod 0.6 mg|1 capsule containing 0.6 mg laquinimod and 2 capsules containing placebo were administered orally once daily for at least 48 weeks.
11379757|NCT02284568|EG002|Reported Event|Laquinimod 1.5 mg|3 capsules containing 0.5 mg laquinimod were administered orally once daily for at least 48 weeks. However this arm was discontinued as of 01 January 2016 and no participants reached the 48 week timeframe.
11379758|NCT02228525|BG000|Baseline|Selinexor (KPT-330)|"Patients with myelodysplastic syndromes who are refractory to hypomethylating agents (decitabine or 5-azacytidine) will receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy. Dose reductions are permitted for patients who are benefiting from selinexor but have poor tolerance. After discontinuation from treatment, patients will be followed by the study staff for survival status approximately every three months.~selinexor (KPT-330)"
11379759|NCT02228525|FG000|Participant Flow|Selinexor (KPT-330)|"Patients with myelodysplastic syndromes who are refractory to hypomethylating agents (decitabine or 5-azacytidine) will receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy. Dose reductions are permitted for patients who are benefiting from selinexor but have poor tolerance. After discontinuation from treatment, patients will be followed by the study staff for survival status approximately every three months.~selinexor (KPT-330)"
10801527|NCT03529773|BG010|Baseline|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
11379760|NCT02228525|OG000|Outcome|Selinexor (KPT-330)|"Patients with myelodysplastic syndromes who are refractory to hypomethylating agents (decitabine or 5-azacytidine) will receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy. Dose reductions are permitted for patients who are benefiting from selinexor but have poor tolerance. After discontinuation from treatment, patients will be followed by the study staff for survival status approximately every three months.~selinexor (KPT-330)"
11379761|NCT02228525|EG000|Reported Event|Selinexor (KPT-330)|"Patients with myelodysplastic syndromes who are refractory to hypomethylating agents (decitabine or 5-azacytidine) will receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy. Dose reductions are permitted for patients who are benefiting from selinexor but have poor tolerance. After discontinuation from treatment, patients will be followed by the study staff for survival status approximately every three months.~selinexor (KPT-330)"
11379762|NCT02227238|BG000|Baseline|Participants Receiving DTG|Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks.
11379763|NCT02227238|BG001|Baseline|Participants Receiving LPV/RTV|Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks.
11379764|NCT02227238|BG002|Baseline|Total|Total of all reporting groups
11379765|NCT02227238|FG000|Participant Flow|Participants Receiving DTG|Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks.
11379766|NCT02227238|FG001|Participant Flow|Participants Receiving LPV/RTV|Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks.
11379767|NCT02227238|OG000|Outcome|Participants Receiving DTG|Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks.
11379768|NCT02227238|OG001|Outcome|Participants Receiving LPV/RTV|Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks.
11379769|NCT02227238|EG000|Reported Event|Participants Receiving DTG|Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks.
10801528|NCT03529773|BG011|Baseline|Sentinel Cohort: RSV 240 mcg Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
11379770|NCT02227238|EG001|Reported Event|Participants Receiving LPV/RTV|Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks.
11379771|NCT02195986|BG000|Baseline|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
11379772|NCT02195986|BG001|Baseline|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
11379773|NCT02195986|BG002|Baseline|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
11379774|NCT02195986|BG003|Baseline|Total|Total of all reporting groups
11379775|NCT02195986|FG000|Participant Flow|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
11379776|NCT02195986|FG001|Participant Flow|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
11379777|NCT02195986|FG002|Participant Flow|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
11379778|NCT02195986|OG000|Outcome|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
11379779|NCT02195986|OG001|Outcome|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
11379780|NCT02195986|OG002|Outcome|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
11379781|NCT02195986|EG000|Reported Event|Estradiol Vaginal Cream|"Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.~Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)"
11379782|NCT02195986|EG001|Reported Event|Estrace® 0.01% Cream|"Estrace® 0.01% vaginal cream, administered once daily for 7 days.~Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)"
11379783|NCT02195986|EG002|Reported Event|Placebo Vaginal Cream|"Placebo Vaginal Cream, administered once daily for 7 days.~Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)"
11379784|NCT02128958|BG000|Baseline|CF102|CF102 25 mg capsules administered orally BID
11379785|NCT02128958|BG001|Baseline|Placebo Tablets of CF102|Placebo capsules administered orally BID
11379786|NCT02128958|BG002|Baseline|Total|Total of all reporting groups
11379787|NCT02128958|FG000|Participant Flow|CF102|CF102 25 mg capsules administered orally BID
11379788|NCT02128958|FG001|Participant Flow|Placebo Tablets of CF102|Placebo capsules administered orally BID
11379789|NCT02128958|OG000|Outcome|CF102|CF102 25 mg capsules administered orally BID
11379790|NCT02128958|OG001|Outcome|Placebo Tablets of CF102|Placebo capsules administered orally BID
11379791|NCT02128958|EG000|Reported Event|CF102|CF102 25 mg capsules administered orally BID
11379792|NCT02128958|EG001|Reported Event|Placebo Tablets of CF102|Placebo capsules administered orally BID
11379793|NCT02086448|BG000|Baseline|Obese, SDB Postive, Sham-CPAP|"Sham (non-therapeutic) CPAP~sham-CPAP"
11379794|NCT02086448|BG001|Baseline|Obese, SDB Postive, CPAP, Phase 1|"Therapeutic CPAP~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing)."
11379795|NCT02086448|BG002|Baseline|Obese, SDB Postive, Sleep Hygiene|"Sleep hygiene information and local sleep resources~Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources"
11379796|NCT02086448|BG003|Baseline|Obese, SDB Positive, CPAP Phase 2|Therapeutic CPAP
11379797|NCT02086448|BG004|Baseline|Total|Total of all reporting groups
11379798|NCT02086448|FG000|Participant Flow|Obese, SDB Postive, CPAP, Phase 1|"Therapeutic CPAP~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing)."
11379799|NCT02086448|FG001|Participant Flow|Obese, SDB Postive, Sham-CPAP|"Sham (non-therapeutic) CPAP~sham-CPAP"
11379800|NCT02086448|FG002|Participant Flow|Obese, SDB Postive, Sleep Hygiene|"Sleep hygiene information and local sleep resources~Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources"
11379801|NCT02086448|FG003|Participant Flow|Obese SDB CPAP Phase 2|Therapeutic CPAP
11379802|NCT02086448|OG000|Outcome|Obese, SDB Postive, Sham-CPAP|"Sham (non-therapeutic) CPAP~sham-CPAP"
11379803|NCT02086448|OG001|Outcome|Obese, SDB Postive, CPAP, Phase 1|"Therapeutic CPAP~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing)."
11379804|NCT02086448|OG002|Outcome|Obese, SDB Postive, Sleep Hygiene|"Sleep hygiene information and local sleep resources~Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources"
11379805|NCT02086448|OG003|Outcome|Obese, SBD Positive, CPAP, Phase 2|Therapeutic CPAP
11379806|NCT02086448|EG000|Reported Event|Obese, SDB Postive, CPAP, Phase 1|"Therapeutic CPAP~CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing)."
11379807|NCT02086448|EG001|Reported Event|Obese, SDB Postive, Sham-CPAP|"Sham (non-therapeutic) CPAP~sham-CPAP"
11379808|NCT02086448|EG002|Reported Event|Obese, SDB Postive, Sleep Hygiene|"Sleep hygiene information and local sleep resources~Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources"
10781223|NCT01411267|OG001|Outcome|AML AC220 @ 25mg/m^2/Day (Dose Level 1)|The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
11379809|NCT02086448|EG003|Reported Event|Obese, SBD Positive, CPAP, Phase 2|Therapeutic CPAP
11379810|NCT01982630|BG000|Baseline|Part 1: MK-8521 64/120 μg/Day|Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
11379811|NCT01982630|BG001|Baseline|Part 1: MK-8521 34/72 μg/Day|T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
11379812|NCT01982630|BG002|Baseline|Part 1: Liraglutide 0.6/1.2/1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
11379813|NCT01982630|BG003|Baseline|Part 1: Placebo for MK-8521|T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
11379814|NCT01982630|BG004|Baseline|Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM|T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
11379815|NCT01982630|BG005|Baseline|Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM|T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
11379816|NCT01982630|BG006|Baseline|Part 2: Placebo for MK-8521-T2DM|T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
11379817|NCT01982630|BG007|Baseline|Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
11379818|NCT01982630|BG008|Baseline|Total|Total of all reporting groups
11379819|NCT01982630|FG000|Participant Flow|Part 1: MK-8521 64/120 μg/Day|Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
11379820|NCT01982630|FG001|Participant Flow|Part 1: MK-8521 34/72 μg/Day|T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
11379821|NCT01982630|FG002|Participant Flow|Part 1: Liraglutide 0.6/1.2/1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
11379822|NCT01982630|FG003|Participant Flow|Part 1: Placebo for MK-8521|T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
11379823|NCT01982630|FG004|Participant Flow|Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM|T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
11379824|NCT01982630|FG005|Participant Flow|Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM|T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
11379825|NCT01982630|FG006|Participant Flow|Part 2: Placebo for MK-8521-T2DM|T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
11379826|NCT01982630|FG007|Participant Flow|Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
11379827|NCT01982630|OG000|Outcome|Part 1: MK-8521 64 μg/Day|Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
11379828|NCT01982630|OG001|Outcome|Part 1: MK-8521 120 μg/Day|T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
11379829|NCT01982630|OG002|Outcome|Part 1: MK-8521 34 μg/Day|T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
11379830|NCT01982630|OG003|Outcome|Part 1: MK-8521 72 μg/Day|T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
11379831|NCT01982630|OG004|Outcome|Part 1: Liraglutide 0.6 mg/Day|T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379832|NCT01982630|OG005|Outcome|Part 1: Liraglutide 1.2 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379833|NCT01982630|OG006|Outcome|Part 1: Liraglutide 1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379834|NCT01982630|OG007|Outcome|Part 1: Placebo for MK-8521|T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
11379835|NCT01982630|OG000|Outcome|Part 2: MK-8521 64 μg/Day|Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120/180/240/300 µg/day treatment group schedule.
11379836|NCT01982630|OG001|Outcome|Part 2: MK-8521 120 μg/Day|T2DM participants received once daily subcutaneous MK-8521 120 µg/day on Days 8 to 14 as part of the MK-8521 64/120/180/240/300 µg/day treatment group schedule.
11379837|NCT01982630|OG002|Outcome|Part 2: MK-8521 180 μg/Day|T2DM participants received once daily subcutaneous MK-8521 180 µg/day on Days 15 to 19 as part of the MK-8521 64/120/180/240/300 µg/day treatment group schedule.
11379838|NCT01982630|OG003|Outcome|Part 2: MK-8521 240 μg/Day|T2DM participants received once daily subcutaneous MK-8521 240 µg/day on Days 20 to 24 as part of the MK-8521 64/120/180/240/300 µg/day treatment group schedule.
11243309|NCT02502149|FG000|Participant Flow|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received recombinant factor VIII Fc fusion protein (rFVIIIFc) (1000 IU/vial strength), 50 International Unit per kilogram (IU/kg), manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
11379839|NCT01982630|OG004|Outcome|Part 2: MK-8521 300 μg/Day|T2DM participants received once daily subcutaneous MK-8521 300 µg/day on Days 25 to 29 as part of the MK-8521 64/120/180/240/300 µg/day treatment group schedule.
11379840|NCT01982630|OG005|Outcome|Part 2: Liraglutide 0.6 mg/Day|T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Days 1 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379841|NCT01982630|OG006|Outcome|Part 2: Liraglutide 1.2 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379842|NCT01982630|OG007|Outcome|Part 2: Liraglutide 1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 15 to 29 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379843|NCT01982630|OG008|Outcome|Part 2: Placebo for MK-8521-T2DM|T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
11379844|NCT01982630|OG009|Outcome|Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
11379845|NCT01982630|OG010|Outcome|Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
11379846|NCT01982630|OG007|Outcome|Part 2: Liraglutide 1.8 mg/Day|Participants received once daily subcutaneous liraglutide 1.8 mg on Days 15 to 29 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379847|NCT01982630|OG000|Outcome|Part 1: MK-8521 64/120 μg/Day|Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
11379848|NCT01982630|OG001|Outcome|Part 1: MK-8521 34/72 μg/Day|T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
11379849|NCT01982630|OG002|Outcome|Part 1: Liraglutide 0.6/1.2/1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
11379850|NCT01982630|OG003|Outcome|Part 1: Placebo for MK-8521|T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
11379851|NCT01982630|OG000|Outcome|Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM|Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
11379852|NCT01982630|OG001|Outcome|Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM|T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
11379853|NCT01982630|OG002|Outcome|Part 2: Placebo for MK-8521-T2DM|T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
11379854|NCT01982630|OG001|Outcome|Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
11193738|NCT02147301|FG000|Participant Flow|DEB-TACE|"Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first"
11193739|NCT02147301|OG000|Outcome|DEB-TACE|"Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first~LC Bead: Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first."
11193740|NCT02147301|EG000|Reported Event|DEB-TACE|"Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first~LC Bead: Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first."
11193741|NCT02147353|BG000|Baseline|Sinecatechins 15% Ointment and Cryotherapy|Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
11193742|NCT02147353|BG001|Baseline|Cryotherapy Alone|Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
11379855|NCT01982630|OG003|Outcome|Part 1: Placebo for MK-8521|Participants received once daily subcutaneous placebo for MK-8521 for 14 days.
11379856|NCT01982630|OG000|Outcome|Part 2: MK-8521 64/120/180/240/300 μg/Day-T2DM|Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 titrated to 300 μg starting at 64 μg and increasing to 120 μg on Day 8, 180 μg on Day 15, 240 μg on Day 20, and 300 μg on Day 25. The total number of dosing days was 29.
11379857|NCT01982630|OG001|Outcome|Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 μg starting at 64 μg and increasing to 120 μg on Day 8. The total number of dosing days was 14.
11379858|NCT01982630|OG000|Outcome|Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 μg starting at 64 μg and increasing to 120 μg on Day 8. The total number of dosing days was 14.
11379859|NCT01982630|EG000|Reported Event|Part 1: MK-8521 64 μg/Day|Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
11379860|NCT01982630|EG001|Reported Event|Part 1: MK-8521 120 μg/Day|T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
10781224|NCT01411267|OG002|Outcome|ALL AC220 @ 40mg/m^2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
11193743|NCT02147353|BG002|Baseline|Total|Total of all reporting groups
11193744|NCT02147353|FG000|Participant Flow|Sinecatechins 15% Ointment & Cryotherapy|"Cryotherapy and then Sinecatechins 15% Ointment 1 week later.~Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance."
11379861|NCT01982630|EG002|Reported Event|Part 1: MK-8521 34 μg/Day|T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
10781225|NCT01411267|OG003|Outcome|AML AC220 @ 40mg/m^2/Day (Dose Level 2)|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
11379862|NCT01982630|EG003|Reported Event|Part 1: MK-8521 72 μg/Day|T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
11379863|NCT01982630|EG004|Reported Event|Part 1: Liraglutide 0.6 mg/Day|T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379864|NCT01982630|EG005|Reported Event|Part 1: Liraglutide 1.2 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379865|NCT01982630|EG006|Reported Event|Part 1: Liraglutide 1.8 mg/Day|T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
11379866|NCT01982630|EG007|Reported Event|Part 1: Placebo for MK-8521|T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
10801529|NCT03529773|BG012|Baseline|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10781226|NCT01411267|OG004|Outcome|ALL AC220 @ 60mg/m^2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781227|NCT01411267|OG005|Outcome|AML AC220 @ 60mg/m^2/Day (Dose Level 3)|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781228|NCT01411267|OG000|Outcome|Patients With ALL|Patients with a diagnosis of acute lymphocytic leukemia at study entry
10781229|NCT01411267|OG001|Outcome|Patients With AML Having FLT3-WT|Patients with a diagnosis of acute myeloid leukemia with internal tandem duplication (ITD) on exon 14 of the FLT3 gene
10781230|NCT01411267|OG002|Outcome|Patients With AML Having FLT3-ITD|Patients with a diagnosis of acute myeloid leukemia having the FLT3 wild-type receptor (FLT3-WT)
10781231|NCT01411267|OG000|Outcome|Patients Receiving Protocol Therapy|All patients receiving protocol therapy
10781232|NCT01411267|EG000|Reported Event|ALL Dose Level 1|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
10781233|NCT01411267|EG001|Reported Event|AML Dose Level 1|The starting dose is Dose Level 1 at 25 mg/m^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.
10781234|NCT01411267|EG002|Reported Event|ALL Dose Level 2|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.
11193745|NCT02147353|FG001|Participant Flow|Cryotherapy Alone|Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
11193746|NCT02147353|OG000|Outcome|Sinecatechins 15% Ointment & Cryotherapy|"Cryotherapy and then Sinecatechins 15% Ointment 1 week later.~Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance."
11193747|NCT02147353|OG001|Outcome|Cryotherapy Alone|Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
10781235|NCT01411267|EG003|Reported Event|AML Dose Level 2|Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age.
10781236|NCT01411267|EG004|Reported Event|ALL Dose Level 3|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781237|NCT01411267|EG005|Reported Event|AML Dose Level 3|Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
10781238|NCT01336634|BG000|Baseline|Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID|Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
10781239|NCT01336634|BG001|Baseline|Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
10781240|NCT01336634|BG002|Baseline|Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
10781241|NCT01336634|BG003|Baseline|Total|Total of all reporting groups
10781242|NCT01336634|FG000|Participant Flow|Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID|Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
10781243|NCT01336634|FG001|Participant Flow|Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
11379867|NCT01982630|EG008|Reported Event|Part 2: MK-8521 64 μg/Day T2DM|Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
11379868|NCT01982630|EG009|Reported Event|Part 2: MK-8521 120 μg/Day T2DM|T2DM participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
11379869|NCT01982630|EG010|Reported Event|Part 2: MK-8521 180 μg/Day T2DM|T2DM participants received once daily subcutaneous MK-8521 180 µg on Days 15 to 19 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
11379870|NCT01982630|EG011|Reported Event|Part 2: MK-8521 240 μg/Day T2DM|T2DM participants received once daily subcutaneous MK-8521 240 µg on Days 20 to 24 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
11379871|NCT01982630|EG012|Reported Event|Part 2: MK-8521 300 μg/Day T2DM|T2DM participants received once daily subcutaneous MK-8521 300 µg on Days 25 to 29 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
11379872|NCT01982630|EG013|Reported Event|Part 2: Liraglutide 0.6 mg/Day T2DM|T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Days 1 to 7 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
11379873|NCT01982630|EG014|Reported Event|Part 2: Liraglutide 1.2 mg/Day T2DM|T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
11379874|NCT01982630|EG015|Reported Event|Part 2: Liraglutide 1.8 mg/Day T2DM|T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 15 to 29 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
11379875|NCT01982630|EG016|Reported Event|Part 2: Placebo for MK-8521-T2DM|T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
11379876|NCT01982630|EG017|Reported Event|Part 2: MK-8521 64 μg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120 µg treatment sequence.
11379877|NCT01982630|EG018|Reported Event|Part 2: MK-8521 120 μg/Day-Non-Diabetic Overweight/Obese|Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120 µg treatment sequence.
11379878|NCT01982448|BG000|Baseline|Arm A: Cisplatin|Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379879|NCT01982448|BG001|Baseline|Arm B: Paclitaxel|Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379880|NCT01982448|BG002|Baseline|Total|Total of all reporting groups
11379881|NCT01982448|FG000|Participant Flow|Arm A: Cisplatin|Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379882|NCT01982448|FG001|Participant Flow|Arm B: Paclitaxel|Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379883|NCT01982448|OG000|Outcome|Arm A: Cisplatin With HRD+|"Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.~HRD+ (score >/=33)"
10781244|NCT01336634|FG002|Participant Flow|Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
11379884|NCT01982448|OG001|Outcome|Arm A: Cisplatin With HRD-|"Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.~HRD- (score <33)"
11379885|NCT01982448|OG002|Outcome|Arm B: Paclitaxel With HRD+|"Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.~HRD+ (score >/=33)"
11379886|NCT01982448|OG003|Outcome|Arm B: Paclitaxel With HRD-|"Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.~HRD- (score <33)"
10781245|NCT01336634|OG000|Outcome|Cohort A (Dabrafenib Monotherapy)|Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
10781246|NCT01336634|OG001|Outcome|Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
10781247|NCT01336634|OG002|Outcome|Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
10781248|NCT01336634|OG003|Outcome|Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD|Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
10781249|NCT01336634|OG000|Outcome|Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID|Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
10781250|NCT01336634|EG000|Reported Event|Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID|Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
10781251|NCT01336634|EG001|Reported Event|Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
10781252|NCT01336634|EG002|Reported Event|Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD|Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
10781253|NCT01336634|EG003|Reported Event|Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD|Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
10781254|NCT01155375|BG000|Baseline|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
10781255|NCT01155375|BG001|Baseline|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
10781256|NCT01155375|BG002|Baseline|Total|Total of all reporting groups
10781257|NCT01155375|FG000|Participant Flow|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4).*Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
10781258|NCT01155375|FG001|Participant Flow|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
10781259|NCT01155375|OG000|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4).*Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
10781260|NCT01155375|OG001|Outcome|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
10781261|NCT01155375|OG000|Outcome|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
10781262|NCT01155375|EG000|Reported Event|Ferumoxytol|"Participants received 1 of the following 2 ferumoxytol dose regimens:~Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.~Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9."
10781263|NCT01155375|EG001|Reported Event|Oral Iron|Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
10781264|NCT00785798|BG000|Baseline|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
10781265|NCT00785798|FG000|Participant Flow|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
10781266|NCT00785798|OG000|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
10781267|NCT00785798|EG000|Reported Event|Vorinostat Doxil|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Vorinostat: 200mg to 400 mg twice daily on days 1-7~Pegylated Liposomal Doxorubicin (PLD), Doxil: IV 30mg/m2 on day 3 of a 21-day cycle"
10781268|NCT00628095|BG000|Baseline|CE-224,535|CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781269|NCT00628095|BG001|Baseline|Placebo|Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781270|NCT00628095|BG002|Baseline|Total|Total of all reporting groups
10781271|NCT00628095|FG000|Participant Flow|CE-224,535|CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781272|NCT00628095|FG001|Participant Flow|Placebo|Placebo tablet matched to CE-224,535 500 mg tablet orally twice daily for 12 weeks.
10781273|NCT00628095|OG000|Outcome|CE-224,535|CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781274|NCT00628095|OG001|Outcome|Placebo|Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781275|NCT00628095|OG000|Outcome|CE-224,535|CE-224,535 500 milligram (mg) tablet twice daily for 12 weeks.
10781276|NCT00628095|OG001|Outcome|Placebo|Placebo matched to CE-224,535 500 milligram (mg) tablet twice daily for 12 weeks.
10781277|NCT00628095|EG000|Reported Event|CE-224,535|CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781278|NCT00628095|EG001|Reported Event|Placebo|Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
10781279|NCT04246021|BG000|Baseline|Ferric Carboxymaltose (Ferrinject)|"Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level.~Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion~If the needed Ferric carboxymaltose dose is > 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion~Ferric carboxymaltose (FCM): intravenous iron formulation"
10781280|NCT04246021|FG000|Participant Flow|Ferric Carboxymaltose (Ferrinject)|"Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level.~Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion~If the needed Ferric carboxymaltose dose is > 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion~Ferric carboxymaltose (FCM): intravenous iron formulation"
10781281|NCT04246021|OG000|Outcome|Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia|"A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited.~Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781282|NCT04246021|OG001|Outcome|Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency|"A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited.~Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781283|NCT04246021|OG002|Outcome|Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia|"A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited.~Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781284|NCT04246021|OG000|Outcome|Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781285|NCT04246021|OG001|Outcome|Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781286|NCT04246021|OG002|Outcome|Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10801530|NCT03529773|BG013|Baseline|Sentinel Cohort: Placebo Age 50-85 Years|Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10781287|NCT04246021|OG002|Outcome|Others, Ferric Carboxymaltose(Ferinject) in Patients With Anemia|"A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited.~Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781288|NCT04246021|OG002|Outcome|Others, Ferric Carboxymaltose(Ferinject) in Patients With Anemia|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)."
10781289|NCT04246021|OG000|Outcome|Ferric Carboxymaltose (Ferrinject)|Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL
10781290|NCT04246021|EG000|Reported Event|Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)"
10781291|NCT04246021|EG001|Reported Event|Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)"
10781292|NCT04246021|EG002|Reported Event|Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia|"Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as others (n = 34)"
10801531|NCT03529773|BG014|Baseline|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801532|NCT03529773|BG015|Baseline|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801533|NCT03529773|BG016|Baseline|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801534|NCT03529773|BG017|Baseline|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801535|NCT03529773|BG018|Baseline|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801536|NCT03529773|BG019|Baseline|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11193748|NCT02147353|EG000|Reported Event|Sinecatechins 15% Ointment & Cryotherapy|"Cryotherapy and then Sinecatechins 15% Ointment 1 week later.~Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance."
10801537|NCT03529773|BG020|Baseline|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801538|NCT03529773|BG021|Baseline|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801539|NCT03529773|BG022|Baseline|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10850590|NCT00303472|EG003|Reported Event|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
11379887|NCT01982448|OG000|Outcome|Arm A: Cisplatin|Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379888|NCT01982448|OG001|Outcome|Arm B: Paclitaxel|Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
11379889|NCT01982448|EG000|Reported Event|Paclitaxel|Paclitaxel will be given as an IV infusion at a dose of 80mg/m2 weekly x 12 weeks (4 cycles).
11379890|NCT01982448|EG001|Reported Event|Cisplatin|Cisplatin will be given by IV at 75 mg/m2 every 3 weeks, 4 cycles.
11379891|NCT01879228|BG000|Baseline|Sitagliptin|"The dose of sitagliptin (Januvia®) 100 mg tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379892|NCT01879228|BG001|Baseline|Placebo|"Placebo tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379893|NCT01879228|BG002|Baseline|Total|Total of all reporting groups
11379894|NCT01879228|FG000|Participant Flow|Sitagliptin|"The dose of sitagliptin (Januvia®) 100 mg tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379895|NCT01879228|FG001|Participant Flow|Placebo|"Placebo tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379896|NCT01879228|OG000|Outcome|Sitagliptin|"The dose of sitagliptin (Januvia®) 100 mg tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379897|NCT01879228|OG001|Outcome|Placebo|"Placebo tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379898|NCT01879228|EG000|Reported Event|Sitagliptin|"The dose of sitagliptin (Januvia®) 100 mg tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379899|NCT01879228|EG001|Reported Event|Placebo|"Placebo tablet will be taken orally each morning for 6 months.~Sitagliptin: The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months."
11379900|NCT01783041|BG000|Baseline|5% Dextrose|"Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.~5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients."
11379901|NCT01783041|BG001|Baseline|L-carnitine|"Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.~L-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients."
11379902|NCT01783041|BG002|Baseline|Total|Total of all reporting groups
11379903|NCT01783041|FG000|Participant Flow|5% Dextrose|"Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.~5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients."
11379904|NCT01783041|FG001|Participant Flow|L-carnitine|"Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.~L-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients."
11379905|NCT01783041|OG000|Outcome|5% Dextrose|"Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.~5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients."
11379906|NCT01783041|OG001|Outcome|L-carnitine|"Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.~L-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients."
11379907|NCT01783041|EG000|Reported Event|5% Dextrose|"Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.~5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients."
11379908|NCT01783041|EG001|Reported Event|L-carnitine|"Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.~L-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients."
11379909|NCT01752920|BG000|Baseline|Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group|Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379910|NCT01752920|BG001|Baseline|Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group|Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379911|NCT01752920|BG002|Baseline|Derazantinib 400 mg QOD - 425 mg QD - High Dose Group|Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379912|NCT01752920|BG003|Baseline|Derazantinib 300 mg QD - Expanded Cohort Group|Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379913|NCT01752920|BG004|Baseline|Total|Total of all reporting groups
11379914|NCT01752920|FG000|Participant Flow|Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group|Subjects who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379915|NCT01752920|FG001|Participant Flow|Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group|Subjects who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379916|NCT01752920|FG002|Participant Flow|Derazantinib 400 mg QOD - 425 mg QD - High Dose Group|Subjects who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379917|NCT01752920|FG003|Participant Flow|Derazantinib 300 mg QD - Expanded Cohort Group|Subjects who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379918|NCT01752920|OG000|Outcome|Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group|Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379919|NCT01752920|OG001|Outcome|Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group|Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379920|NCT01752920|OG002|Outcome|Derazantinib 400 mg QOD - 425 mg QD - High Dose Group|Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379921|NCT01752920|OG003|Outcome|Derazantinib 300 mg QD - Expanded Cohort Group|Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379922|NCT01752920|OG001|Outcome|Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group|Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379923|NCT01752920|OG003|Outcome|Derazantinib 300 mg QD - Expanded Cohort Group|Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria .
11379924|NCT01752920|EG000|Reported Event|Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group|Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379925|NCT01752920|EG001|Reported Event|Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group|Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379926|NCT01752920|EG002|Reported Event|Derazantinib 400 mg QOD - 425 mg QD - High Dose Group|Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379927|NCT01752920|EG003|Reported Event|Derazantinib 300 mg QD - Expanded Cohort Group|Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
11379928|NCT01744093|BG000|Baseline|Doxycycline|Doxycycline x 100 mg BID (orally) for 24 weeks
11379929|NCT01744093|BG001|Baseline|Placebo (Sugar Pill)|Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
11379930|NCT01744093|BG002|Baseline|Total|Total of all reporting groups
11379931|NCT01744093|FG000|Participant Flow|Doxycycline|Doxycycline x 100 mg twice daily (BID orally) for 24 weeks
11379932|NCT01744093|FG001|Participant Flow|Placebo (Sugar Pill)|One pill twice daily (BID orally) for 24 weeks
11379933|NCT01744093|OG000|Outcome|Doxycycline|Doxycycline x 100 mg BID (orally) for 24 weeks
11379934|NCT01744093|OG001|Outcome|Placebo (Sugar Pill)|Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
11379935|NCT01744093|OG000|Outcome|Doxycycline|"100 mg twice daily (BID orally) x 24 weeks~Doxycycline: 100 mg twice daily (BID orally) x 24 weeks"
11379936|NCT01744093|OG001|Outcome|Placebo (Sugar Pill)|"100 mg twice daily (BID orally) x 24 weeks~Placebo (sugar pill): 100 mg twice daily (BID orally) x 24 weeks"
11379937|NCT01744093|OG000|Outcome|Doxycycline|"100 mg twice daily (BID orally) x 24 weeks~Doxycycline: 100 mg twice daily (BID orally) x 24 Weeks"
11379938|NCT01744093|OG001|Outcome|Placebo (Sugar Pill)|"One pill twice daily (BID orally) x 24 Weeks~Placebo (sugar pill): One pill twice daily (BID orally) x 24 Weeks"
11379939|NCT01744093|OG000|Outcome|Doxycycline|100 mg twice daily (BID orally) x 24 Weeks
11379940|NCT01744093|OG001|Outcome|Placebo (Sugar Pill)|One pill twice daily (BID orally) x 24 Weeks
11379941|NCT01744093|OG000|Outcome|Doxycycline|"100 mg twice daily (BID orally) x 24 Weeks~Doxycycline: 100 mg twice daily (BID orally) x 24 Weeks"
11379942|NCT01744093|OG001|Outcome|Placebo (Sugar Pill)|"One pill (BID orally) x 24 Weeks~Placebo (sugar pill): One pill twice daily (BID orally) x 24 Weeks"
11379943|NCT01744093|EG000|Reported Event|Doxycycline|Doxycycline x 100 mg BID (orally) for 24 weeks.
11379944|NCT01744093|EG001|Reported Event|Placebo (Sugar Pill)|Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks.
11379945|NCT01740297|BG000|Baseline|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379946|NCT01740297|BG001|Baseline|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
11193749|NCT02147353|EG001|Reported Event|Cryotherapy Alone|Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
11379947|NCT01740297|BG002|Baseline|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379948|NCT01740297|BG003|Baseline|Total|Total of all reporting groups
11379949|NCT01740297|FG000|Participant Flow|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379950|NCT01740297|FG001|Participant Flow|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
11193750|NCT02147522|BG000|Baseline|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
11379951|NCT01740297|FG002|Participant Flow|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379952|NCT01740297|OG000|Outcome|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379953|NCT01740297|OG000|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
11379954|NCT01740297|OG001|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379955|NCT01740297|OG001|Outcome|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
11379956|NCT01740297|OG002|Outcome|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379957|NCT01740297|EG000|Reported Event|Phase 1b: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors with maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379958|NCT01740297|EG001|Reported Event|Phase 2: Ipilimumab|Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
11379959|NCT01740297|EG002|Reported Event|Phase 2: Talimogene Laherparepvec + Ipilimumab|Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors with a maximum total volume of 4 mL. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL total) began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
11379960|NCT01729754|BG000|Baseline|Tildrakizumab 200 mg (Part 1)|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).
11379961|NCT01729754|BG001|Baseline|Tildrakizumab 100 mg (Part 1)|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12 (Part 1).
11379962|NCT01729754|BG002|Baseline|Placebo (Part 1)|Participants received tildrakizumab placebo SC at Weeks 0 and 4 and etanercept placebo SC twice weekly until Week 12 (Part 1).
11379963|NCT01729754|BG003|Baseline|Etanercept 50 mg (Part 1)|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
11379964|NCT01729754|BG004|Baseline|Total|Total of all reporting groups
11379965|NCT01729754|FG000|Participant Flow|Tildrakizumab 200 mg (Parts 1 & 2)|Participants received tildrakizumab 200 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379966|NCT01729754|FG001|Participant Flow|Tildrakizumab 200 mg (Parts 1, 2, & 3)|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379967|NCT01729754|FG002|Participant Flow|Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3)|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 100 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379968|NCT01729754|FG003|Participant Flow|Tildrakizumab 100 mg (Parts 1 & 2)|Participants received tildrakizumab 100 mg subcutaneously (SC) on Weeks 0 and 4 (Part 1), and Week 16 (Part 2) plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379969|NCT01729754|FG004|Participant Flow|Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379970|NCT01729754|FG005|Participant Flow|Tildrakizumab 100 mg (Parts 1, 2, & 3)|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379971|NCT01729754|FG006|Participant Flow|Placebo (Part 1)|Participants received PBO to tildrakizumab SC on Weeks 0 and 4 plus etanercept PBO twice weekly until Week 12 (Part 1).
11379972|NCT01729754|FG007|Participant Flow|Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)|Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379973|NCT01729754|FG008|Participant Flow|Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)|Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28
11379974|NCT01729754|FG009|Participant Flow|Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
10781293|NCT04098497|BG000|Baseline|ACT-based Microintervention Delivered by Mobile App|"The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.~Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.~Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
11379975|NCT01729754|OG000|Outcome|Tildrakizumab 200 mg|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
11379976|NCT01729754|OG001|Outcome|Tildrakizumab 100 mg|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
11379977|NCT01729754|OG002|Outcome|Placebo|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly until Week 12.
11379978|NCT01729754|OG003|Outcome|Etanercept 50 mg|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly until Week 12.
11379979|NCT01729754|OG000|Outcome|Tildrakizumab 200 mg|Participants received tildrakizumab 200 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379980|NCT01729754|OG001|Outcome|Tildrakizumab 100 mg|Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379981|NCT01729754|OG002|Outcome|Etanercept 50 mg|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.
11379982|NCT01729754|OG000|Outcome|Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
11379983|NCT01729754|OG001|Outcome|Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) Wk-28 R|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 100 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28 and re-randomized to tildrakizumab 100 mg at Week 28.
11193751|NCT02147522|BG001|Baseline|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
11379984|NCT01729754|OG002|Outcome|Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI responders at Week 28.
11379985|NCT01729754|OG003|Outcome|Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 PR|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI partial responders at Week 28.
11379986|NCT01729754|OG004|Outcome|Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Wk-28 PR|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and tildrakizumab 200 mg SC on Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28 and re-randomized to tildrakizumab 200 mg at Week 28.
11379987|NCT01729754|OG005|Outcome|Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 PR|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI partial responders at Week 28.
11379988|NCT01729754|OG006|Outcome|Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)|Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 200 mg for Part 2.
11379989|NCT01729754|OG007|Outcome|Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)|Participants received PBO to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants who were randomized to placebo in Part 1 and who were re-randomized to tildrakizumab 100 mg for Part 2.
11379990|NCT01729754|OG008|Outcome|Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48.
11379991|NCT01729754|OG000|Outcome|Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40 and 52 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 200 mg in Part 1 who were PASI responders at Week 28.
11379992|NCT01729754|OG008|Outcome|Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3)|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who didn't achieve PASI-75 at Week 28, received tildrakizumab 200 mg SC at Weeks 32, 36 and 48. Arm includes participants who were non-responders or partial responders to etanercept and re-randomized at Week 28 to receive tildrakizumab 200 mg.
11379993|NCT01729754|OG001|Outcome|Tildrakizumab 100 mg|Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16 and 28 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379994|NCT01729754|OG001|Outcome|Tildrakizumab 100 mg|Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and 16 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379995|NCT01729754|OG001|Outcome|Tildrakizumab 100 mg|Participants received tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379996|NCT01729754|OG003|Outcome|Placebo (Part 1)/ Tildrakizumab 200 mg (Part 2)|Participants received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 200 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11379997|NCT01729754|OG004|Outcome|Placebo (Part 1)/ Tildrakizumab 100 mg (Part 2)|Participants received placebo to tildrakizumab SC on Weeks 0 and 4 (Part 1), and tildrakizumab 100 mg SC on Weeks 12 and 16 (Part 2) plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
10781294|NCT04098497|FG000|Participant Flow|ACT-based Microintervention Delivered by Mobile App|"The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.~Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.~Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
11193752|NCT02147522|BG002|Baseline|Total|Total of all reporting groups
11193753|NCT02147522|FG000|Participant Flow|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
11379998|NCT01729754|OG002|Outcome|Tildrakizumab 100 mg (Parts 1, 2, & 3) Wk-28 R|Participants received tildrakizumab 100 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28. Arm includes participants randomized to tildrakizumab 100 mg in Part 1 who were PASI responders at Week 28
11379999|NCT01729754|EG000|Reported Event|Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R|Participants received tildrakizumab 200 mg SC on Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28 and 40 (Part 3) plus etanercept PBO twice weekly until Week 12 and once weekly from Week 12 to Week 28.
11380000|NCT01729754|EG001|Reported Event|Tildrakizumab 100 mg (Parts 1, 2 & 3)|Participants received tildrakizumab 100 mg SC on Weeks 0, 4 and then every 12 weeks.
11380001|NCT01729754|EG002|Reported Event|Placebo (Part 1)|Participants received matching placebo to tildrakizumab SC on Weeks 0 and 4.
11380002|NCT01729754|EG003|Reported Event|Etanercept 50 mg (Parts 1 & 2)|Participants received etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28.
11380003|NCT01684826|BG000|Baseline|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11380004|NCT01684826|FG000|Participant Flow|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11380005|NCT01684826|OG000|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11380006|NCT01684826|EG000|Reported Event|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
11380007|NCT01672242|BG000|Baseline|Participants|Normal healthy adult volunteers
11380008|NCT01672242|FG000|Participant Flow|HFNC-CPAP|High flow nasal cannula oxygen first period, followed by continuous positive airway pressure second period.
11380009|NCT01672242|FG001|Participant Flow|CPAP-HFNC|Continuous Positive Airway Pressure first period, followed by high flow nasal cannula second period.
11380010|NCT01672242|OG000|Outcome|HFNC|High flow nasal cannula oxygen 40 liters/min
11380011|NCT01672242|OG001|Outcome|CPAP|Continuous positive airway pressure 20 cm H2O
11380012|NCT01672242|EG000|Reported Event|HFNC|High flow nasal cannula
11380013|NCT01672242|EG001|Reported Event|CPAP|Continuous positive airway pressure
11380014|NCT01668784|BG000|Baseline|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380015|NCT01668784|BG001|Baseline|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380016|NCT01668784|BG002|Baseline|Total|Total of all reporting groups
11380017|NCT01668784|FG000|Participant Flow|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380018|NCT01668784|FG001|Participant Flow|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380019|NCT01668784|OG000|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
10964552|NCT00878189|OG006|Outcome|PF-03084014 220 mg BID in Solid Tumor Participants|PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11380020|NCT01668784|OG001|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380021|NCT01668784|EG000|Reported Event|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380022|NCT01668784|EG001|Reported Event|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
11380023|NCT01599741|BG000|Baseline|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
11380024|NCT01599741|FG000|Participant Flow|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
11380025|NCT01599741|OG000|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
11380026|NCT01599741|EG000|Reported Event|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
11380027|NCT01593852|BG000|Baseline|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
11380028|NCT01593852|BG001|Baseline|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
11380029|NCT01593852|BG002|Baseline|Total|Total of all reporting groups
11380030|NCT01593852|FG000|Participant Flow|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
11380031|NCT01593852|FG001|Participant Flow|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
11380032|NCT01593852|OG000|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
11380033|NCT01593852|OG001|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
11380034|NCT01593852|EG000|Reported Event|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
11380035|NCT01593852|EG001|Reported Event|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
11380036|NCT01564537|BG000|Baseline|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380037|NCT01564537|BG001|Baseline|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380038|NCT01564537|BG002|Baseline|Total|Total of all reporting groups
11380039|NCT01564537|FG000|Participant Flow|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
11380040|NCT01564537|FG001|Participant Flow|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380041|NCT01564537|OG000|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380042|NCT01564537|OG001|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380043|NCT01564537|OG000|Outcome|Ixazomib + Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380044|NCT01564537|EG000|Reported Event|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity up to EOT projected at 80 months.
11380045|NCT01564537|EG001|Reported Event|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
11380046|NCT01515306|BG000|Baseline|Part A: Paclitaxel and Ramucirumab|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
11380047|NCT01515306|BG001|Baseline|Part B: Ramucirumab With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
11380048|NCT01515306|BG002|Baseline|Total|Total of all reporting groups
11380049|NCT01515306|FG000|Participant Flow|Part A: Paclitaxel and Ramucirumab|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
11380050|NCT01515306|FG001|Participant Flow|Part B: Ramucirumab With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
11380051|NCT01515306|OG000|Outcome|Part A: Paclitaxel Alone (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
11380052|NCT01515306|OG000|Outcome|Part A: Paclitaxel + Ramucirumab (Cycle 2)|Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
10801540|NCT03529773|BG023|Baseline|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
11193754|NCT02147522|FG001|Participant Flow|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
11380053|NCT01515306|OG000|Outcome|Part B: Ramucirumab Alone (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
11380054|NCT01515306|OG000|Outcome|Part A: Paclitaxel and Ramucirumab (Cycle 2)|Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
11380055|NCT01515306|EG000|Reported Event|Part A: Paclitaxel Alone (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
11380056|NCT01515306|EG001|Reported Event|Part A: Paclitaxel + Ramucirumab (Cycle 2)|Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
11380057|NCT01515306|EG002|Reported Event|Part B: Ramucirumab Alone (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
11380058|NCT01515306|EG003|Reported Event|Part B: Ramucirumab + Paclitaxel (Cycle 2)|Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
11380059|NCT01423851|BG000|Baseline|Part 1: 75 mg QD|Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380060|NCT01423851|BG001|Baseline|Part 1: 125 mg QD|Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380061|NCT01423851|BG002|Baseline|Part 1: 200 mg QD|Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380062|NCT01423851|BG003|Baseline|Part 1: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380063|NCT01423851|BG004|Baseline|Part 1: 400 mg QD|Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380064|NCT01423851|BG005|Baseline|Part 1: 100 mg BID|Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380065|NCT01423851|BG006|Baseline|Part 1: 200 mg BID|Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380066|NCT01423851|BG007|Baseline|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380067|NCT01423851|BG008|Baseline|Part 1: 300 mg BID|Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380068|NCT01423851|BG009|Baseline|Part 1: 400 mg BID|Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380069|NCT01423851|BG010|Baseline|Part 2: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380070|NCT01423851|BG011|Baseline|Total|Total of all reporting groups
11380071|NCT01423851|FG000|Participant Flow|Part 1: 75 mg QD|Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380072|NCT01423851|FG001|Participant Flow|Part 1: 125 mg QD|Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380073|NCT01423851|FG002|Participant Flow|Part 1: 200 mg QD|Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380074|NCT01423851|FG003|Participant Flow|Part 1: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380075|NCT01423851|FG004|Participant Flow|Part 1: 400 mg QD|Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380076|NCT01423851|FG005|Participant Flow|Part 1: 100 mg BID|Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380077|NCT01423851|FG006|Participant Flow|Part 1: 200 mg BID|Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380078|NCT01423851|FG007|Participant Flow|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380079|NCT01423851|FG008|Participant Flow|Part 1: 300 mg BID|Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380080|NCT01423851|FG009|Participant Flow|Part 1: 400 mg BID|Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380081|NCT01423851|FG010|Participant Flow|Part 2: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380082|NCT01423851|OG000|Outcome|Part 1: 75 mg QD|Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380083|NCT01423851|OG001|Outcome|Part 1: 125 mg QD|Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380084|NCT01423851|OG002|Outcome|Part 1: 200 mg QD|Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380085|NCT01423851|OG003|Outcome|Part 1: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380086|NCT01423851|OG004|Outcome|Part 1: 400 mg QD|Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380087|NCT01423851|OG005|Outcome|Part 1: 100 mg BID|Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380088|NCT01423851|OG006|Outcome|Part 1: 200 mg BID|Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380089|NCT01423851|OG007|Outcome|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380090|NCT01423851|OG008|Outcome|Part 1: 300 mg BID|Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380091|NCT01423851|OG009|Outcome|Part 1: 400 mg BID|Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380092|NCT01423851|OG010|Outcome|Part 2: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380093|NCT01423851|OG000|Outcome|Part 2: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380094|NCT01423851|OG009|Outcome|Part 1: 400 mg BID|Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380095|NCT01423851|OG007|Outcome|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380096|NCT01423851|OG007|Outcome|Part 1: 300 mg BID|Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380097|NCT01423851|OG008|Outcome|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380098|NCT01423851|EG000|Reported Event|Part 1: 75 mg QD|Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380099|NCT01423851|EG001|Reported Event|Part 1: 125 mg QD|Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380100|NCT01423851|EG002|Reported Event|Part 1: 200 mg QD|Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380101|NCT01423851|EG003|Reported Event|Part 1: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380102|NCT01423851|EG004|Reported Event|Part 1: 400 mg QD|Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380103|NCT01423851|EG005|Reported Event|Part 1: 100 mg BID|Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380104|NCT01423851|EG006|Reported Event|Part 1: 200 mg BID|Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380105|NCT01423851|EG007|Reported Event|Part 1: 250 mg BID|Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380106|NCT01423851|EG008|Reported Event|Part 1: 300 mg BID|Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
10850591|NCT00303472|EG004|Reported Event|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
10850592|NCT00303472|EG005|Reported Event|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
10850593|NCT00303472|EG006|Reported Event|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
10850594|NCT00303485|BG000|Baseline|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
10850595|NCT00303485|BG001|Baseline|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
10850596|NCT00303485|BG002|Baseline|Total|Total of all reporting groups
10850597|NCT00303485|FG000|Participant Flow|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
10850598|NCT00303485|FG001|Participant Flow|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
10850599|NCT00303485|OG000|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
11380107|NCT01423851|EG009|Reported Event|Part 1: 400 mg BID|Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380108|NCT01423851|EG010|Reported Event|Part 2: 300 mg QD|Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.
11380109|NCT01385176|BG000|Baseline|Therapy|Therapy group was implanted with study system like the control arm, but did receive therapy soon after implant
11380110|NCT01385176|BG001|Baseline|Control|"Control group was implanted with study system like the experimental arm, but will receive no therapy until 6-month cross-over.~Vagal Nerve Stimulation System was implanted but inactive for the first 6 months: Patients randomized to therapy arm with receive right vagal nerve stimulation. Patients randomized to control arm will not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy."
11380111|NCT01385176|BG002|Baseline|Total|Total of all reporting groups
11380112|NCT01385176|FG000|Participant Flow|Therapy|"Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group.~Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period.~The experimental arm was receiving vagus nerve stimulation soon after implant. Patients randomized to control arm were not receiving right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy."
11380113|NCT01385176|FG001|Participant Flow|Control|"Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over.~Vagal Nerve Stimulation System was implanted but inactive for the first 6 months after implant:~Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy."
11380114|NCT01385176|OG000|Outcome|Therapy|"Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period.~The experimental arm was receiving vagus nerve stimulation starting at Baseline."
11380115|NCT01385176|OG001|Outcome|Control|"Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation.~Vagal Nerve Stimulation System was implanted but inactive for the first 6 months."
11380116|NCT01385176|OG000|Outcome|All Patients in Active VNS Periods|All patients in VNS active study periods. Therapy 0-18 months and Control 6-18 months.
11380117|NCT01385176|OG001|Outcome|Control|"Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they also did receive vagus nerve stimulation.~Vagal Nerve Stimulation System was implanted but inactive for the first 6 months."
11380118|NCT01385176|OG001|Outcome|Control|"Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they did also receive vagus nerve stimulation.~Vagal Nerve Stimulation System was implanted but inactive for the first 6 months."
11380119|NCT01385176|OG001|Outcome|Control|"Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they did also receive vagus nerve stimulation.~Vagal Nerve Stimulation. System was implanted but inactive for the first 6 months."
11380120|NCT01385176|EG000|Reported Event|Therapy|"Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group.~Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period.~Patients randomized to therapy arm were receiving right vagal nerve stimulation shortly after implant."
10850600|NCT00303485|OG001|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
11380121|NCT01385176|EG001|Reported Event|Control|"Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over.~Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy."
11380122|NCT01385176|EG002|Reported Event|All Patients - 6 to 18 Months|"All patients were receiving vagus nerve stimulation after the initial 6 months of randomization.~Three of the initially 95 randomized patients died before the end of the randomization phase, reducing the number to 92 patients.~Note, 5 patients did not complete the Randomization phase with the 6 month follow up visit, but were still participating in the study at the time the Randomization Phase Analysis was done. These 5 patients were at risk to have an AE and were included in this analysis set (N=92)"
10850601|NCT00303485|EG000|Reported Event|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
10850602|NCT00303485|EG001|Reported Event|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
10850603|NCT00303511|BG000|Baseline|ACHD With Pacemaker|
10850604|NCT00303511|FG000|Participant Flow|ACHD With Pacemaker|
10850605|NCT00303511|OG000|Outcome|Cohort|
10850606|NCT00303511|EG000|Reported Event|ACHD With Pacemaker|
10850607|NCT00303602|BG000|Baseline|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
10850608|NCT00303602|BG001|Baseline|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
10850609|NCT00303602|BG002|Baseline|Total|Total of all reporting groups
11380123|NCT01360593|BG000|Baseline|Gem + Xeloda + SBRT|"Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.~Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.~Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day."
11380124|NCT01360593|FG000|Participant Flow|Gem + Xeloda + SBRT|"Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.~Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.~Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day."
11380125|NCT01360593|OG000|Outcome|Gem + Xeloda + SBRT|"Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.~Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.~Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day."
11380126|NCT01360593|EG000|Reported Event|Gem + Xeloda + SBRT|"Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.~Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.~Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day."
11380127|NCT01354977|BG000|Baseline|Resveratrol|Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days
11380128|NCT01354977|BG001|Baseline|Placebo|Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days
11380129|NCT01354977|BG002|Baseline|Total|Total of all reporting groups
11380130|NCT01354977|FG000|Participant Flow|Resveratrol|"Each participant received resveratrol, 1,000mg twice daily for 28 days in a randomized, double blinded placebo-controlled fashion.~The investigators used a research procedure called a pancreatic clamp study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism."
11380131|NCT01354977|FG001|Participant Flow|Placebo|"Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days in a randomized, double blinded placebo-controlled fashion.~The investigators used a research procedure called a pancreatic clamp study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism."
11380132|NCT01354977|OG000|Outcome|Resveratrol|Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.
11380133|NCT01354977|OG001|Outcome|Placebo|Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
11380134|NCT01354977|EG000|Reported Event|Resveratrol|Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days.
11380135|NCT01354977|EG001|Reported Event|Placebo|Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days.
11380136|NCT01334606|BG000|Baseline|All Study Participants|This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
11380137|NCT01334606|FG000|Participant Flow|All Study Participants|Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
11380138|NCT01334606|OG000|Outcome|All Subjects|Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed.
11380139|NCT01334606|EG000|Reported Event|All Study Participants|This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
11380140|NCT01334606|EG001|Reported Event|4mmx32G Pen Needle|Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
10803738|NCT02255656|OG002|Outcome|Alemtuzumab (Overall)|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
11380141|NCT01334606|EG002|Reported Event|8mmx31G Pen Needle|Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
11380142|NCT01317875|BG000|Baseline|Stratum 1 : Cohort 1|Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
11380143|NCT01317875|BG001|Baseline|Stratum 1 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
11380144|NCT01317875|BG002|Baseline|Stratum 1 : Cohort 3|Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380145|NCT01317875|BG003|Baseline|Stratum 1 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
11380146|NCT01317875|BG004|Baseline|Stratum 1 : Cohort 5|Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380147|NCT01317875|BG005|Baseline|Stratum 2 : Cohort 1|Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
11380148|NCT01317875|BG006|Baseline|Stratum 2 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10^9/L
11380149|NCT01317875|BG007|Baseline|Stratum 2 : Cohort 3|Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380150|NCT01317875|BG008|Baseline|Stratum 2 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
11380151|NCT01317875|BG009|Baseline|Stratum 2 : Cohort 5|Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380152|NCT01317875|BG010|Baseline|Total|Total of all reporting groups
11380153|NCT01317875|FG000|Participant Flow|Stratum 1 : Cohort 1|Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
11380154|NCT01317875|FG001|Participant Flow|Stratum 1 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
11380155|NCT01317875|FG002|Participant Flow|Stratum 1 : Cohort 3|Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380156|NCT01317875|FG003|Participant Flow|Stratum 1 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
11380157|NCT01317875|FG004|Participant Flow|Stratum 1 : Cohort 5|Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380158|NCT01317875|FG005|Participant Flow|Stratum 2 : Cohort 1|Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
11380159|NCT01317875|FG006|Participant Flow|Stratum 2 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
11380160|NCT01317875|FG007|Participant Flow|Stratum 2 : Cohort 3|Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380161|NCT01317875|FG008|Participant Flow|Stratum 2 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
11380162|NCT01317875|FG009|Participant Flow|Stratum 2 : Cohort 5|Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380163|NCT01317875|OG000|Outcome|Stratum 1 : Cohort 1|Ruxolitinib was administered at 5 mg bid
11380164|NCT01317875|OG001|Outcome|Stratum 1 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
11380165|NCT01317875|OG002|Outcome|Stratum 1 : Cohort 3|Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
11380166|NCT01317875|OG003|Outcome|Stratum 1 : Cohort 4|Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
11380167|NCT01317875|OG004|Outcome|Stratum 1 : Cohort 5|Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
11380168|NCT01317875|OG005|Outcome|Stratum 2 : Cohort 1|Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
11380169|NCT01317875|OG006|Outcome|Stratum 2 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
11380170|NCT01317875|OG007|Outcome|Stratum 2 : Cohort 3|Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
11380171|NCT01317875|OG000|Outcome|Stratum 1 : Group 1|Ruxolitinib was administered to Cohort 1 (5 mg bid) + Cohort 2 (5 mg q.AM / 10 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
11380172|NCT01317875|OG001|Outcome|Stratum 1 : Group 2|Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380173|NCT01317875|OG002|Outcome|Stratum 1 : Group 3|Ruxolitinib was administered Cohort 4 (10 mg q.AM / 15 mg q.PM) + Cohort 5 (15 mg bid) in Participants with baseline Platelet counts of 75-99 x10^9/L.
11380174|NCT01317875|OG003|Outcome|Stratum 2 : Group 1|Ruxolitinib was administered to Cohort 1 (5 mg bid) + Cohort 2 (5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10^9/L
11380175|NCT01317875|OG004|Outcome|Stratum 2 : Group 2|Ruxolitinib was administered Cohort 3 (10 mg bid) in participants with baseline Platelet counts of 50-74 x10^9/L
11380176|NCT01317875|OG000|Outcome|Stratum 1|Participants with baseline Platelet counts of 75-99 x10^9/L
11380177|NCT01317875|OG001|Outcome|Stratum 2|Participants with baseline Platelet counts of 50-74 x10^9/L
11380178|NCT01317875|OG000|Outcome|5mg BID|ruxolitinib was administered at 5 mg BID
11380179|NCT01317875|OG001|Outcome|10mg BID|ruxolitinib was administered at 10 mg BID
11380180|NCT01317875|OG002|Outcome|15 mg BID|ruxolitinib was administered at 15 mg BID
11380181|NCT01317875|EG000|Reported Event|Stratum 1 : Cohort 1|Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
11380182|NCT01317875|EG001|Reported Event|Stratum 1 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
11380183|NCT01317875|EG002|Reported Event|Stratum 1 : Cohort 3|Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380184|NCT01317875|EG003|Reported Event|Stratum 1 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
11380185|NCT01317875|EG004|Reported Event|Stratum 1 : Cohort 5|Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
11380186|NCT01317875|EG005|Reported Event|Stratum 2 : Cohort 1|Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
11193755|NCT02147522|OG000|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
11193756|NCT02147522|OG001|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
11193757|NCT02147522|EG000|Reported Event|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
11193758|NCT02147522|EG001|Reported Event|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.~PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
11380187|NCT01317875|EG006|Reported Event|Stratum 2 : Cohort 2|Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10^9/L
11380188|NCT01317875|EG007|Reported Event|Stratum 2 : Cohort 3|Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380189|NCT01317875|EG008|Reported Event|Stratum 2 : Cohort 4|Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
11380190|NCT01317875|EG009|Reported Event|Stratum 2 : Cohort 5|Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
11380191|NCT01226732|BG000|Baseline|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11193759|NCT02147561|BG000|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
11193760|NCT02147561|FG000|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
11193761|NCT02147561|OG000|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
11193762|NCT02147561|EG000|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
11193763|NCT02147587|BG000|Baseline|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
11193764|NCT02147587|BG001|Baseline|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
11193765|NCT02147587|BG002|Baseline|Total|Total of all reporting groups
11193766|NCT02147587|FG000|Participant Flow|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
11380192|NCT01226732|BG001|Baseline|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380193|NCT01226732|BG002|Baseline|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380194|NCT01226732|BG003|Baseline|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380195|NCT01226732|BG004|Baseline|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380196|NCT01226732|BG005|Baseline|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380197|NCT01226732|BG006|Baseline|Total|Total of all reporting groups
11380198|NCT01226732|FG000|Participant Flow|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380199|NCT01226732|FG001|Participant Flow|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380200|NCT01226732|FG002|Participant Flow|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380201|NCT01226732|FG003|Participant Flow|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380202|NCT01226732|FG004|Participant Flow|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380203|NCT01226732|FG005|Participant Flow|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380204|NCT01226732|OG000|Outcome|All Patients|The Maximum Tolerated Dose (MTD) is determined for all patients
11380205|NCT01226732|OG000|Outcome|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380206|NCT01226732|OG001|Outcome|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380207|NCT01226732|OG002|Outcome|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380208|NCT01226732|OG003|Outcome|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380209|NCT01226732|OG004|Outcome|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380210|NCT01226732|OG005|Outcome|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380211|NCT01226732|OG000|Outcome|Dose Level 1|Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
11380212|NCT01226732|OG001|Outcome|Dose Level 2|Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
11380213|NCT01226732|OG002|Outcome|Dose Level 3|Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
11380214|NCT01226732|OG003|Outcome|Dose Level 4|Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
11380215|NCT01226732|OG004|Outcome|Dose Level 5|Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
11380216|NCT01226732|OG005|Outcome|Dose Level 6|Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
11380217|NCT01226732|EG000|Reported Event|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380218|NCT01226732|EG001|Reported Event|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380219|NCT01226732|EG002|Reported Event|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380220|NCT01226732|EG003|Reported Event|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
10801541|NCT03529773|BG024|Baseline|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
11380221|NCT01226732|EG004|Reported Event|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380222|NCT01226732|EG005|Reported Event|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
11380223|NCT01216683|BG000|Baseline|Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)|"Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity."
11380224|NCT01216683|BG001|Baseline|Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)|"Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D."
11380225|NCT01216683|BG002|Baseline|Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)|"Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity."
11380226|NCT01216683|BG003|Baseline|Total|Total of all reporting groups
11380227|NCT01216683|FG000|Participant Flow|Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)|"Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~Bendamustin: Given IV"
11380228|NCT01216683|FG001|Participant Flow|Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)|"Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.~rituximab: Given IV~Bendamustin: Given IV~bortezomib: Given IV"
11380229|NCT01216683|FG002|Participant Flow|Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)|"Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~Bendamustin: Given IV~lenalidomide: Given orally"
11380230|NCT01216683|OG000|Outcome|Arm A and Arm C (Induction With Bendamustine + Rituximab)|Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11380231|NCT01216683|OG001|Outcome|Arm B (Induction With Bendamustine + Rituximab + Bortezomib)|Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11380232|NCT01216683|OG000|Outcome|Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)|"Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity."
11193767|NCT02147587|FG001|Participant Flow|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
11193768|NCT02147587|OG000|Outcome|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
11193769|NCT02147587|OG001|Outcome|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
11380233|NCT01216683|OG001|Outcome|Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)|"Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity."
11380234|NCT01216683|OG001|Outcome|Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)|"Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D."
11380235|NCT01216683|OG002|Outcome|Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)|"Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity."
11380236|NCT01216683|OG000|Outcome|FLIPI 0-2/Unknown|Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 0-2 or unknown.
11380237|NCT01216683|OG001|Outcome|FLIPI 3-5|Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 3-5.
11380238|NCT01216683|OG000|Outcome|CIRS <10|Patients with baseline Cumulative Illness Rating Scale (CIRS) score <10
11380239|NCT01216683|OG001|Outcome|CIRS >=10|Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10
11380240|NCT01216683|OG001|Outcome|CIRS >=10|Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10.
11380241|NCT01216683|OG000|Outcome|Subcutaneous Bortezomib|Patients who received subcutaneous bortezomib.
11380242|NCT01216683|OG001|Outcome|Intravenous Bortezomib|Patients who received intravenous bortezomib. Patients who received both subcutaneous and intravenous bortezomib are included in the intravenous bortezomib group.
11380243|NCT01216683|EG000|Reported Event|Arm A|Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11380244|NCT01216683|EG001|Reported Event|Arm B|Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11380245|NCT01216683|EG002|Reported Event|Arm C|Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11380246|NCT01216683|EG003|Reported Event|Arm D|Arm D (continuation after Arm A): Beginning 4 weeks after the completion of Arm A induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
11380247|NCT01216683|EG004|Reported Event|Arm E|Arm E (continuation after Arm B): Beginning 4 weeks after the completion of Arm B induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
11380248|NCT01216683|EG005|Reported Event|Arm F|Arm F (continuation after Arm C): Immediately after completing Arm C induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
11380249|NCT01085097|BG000|Baseline|Placebo|Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380250|NCT01085097|BG001|Baseline|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380251|NCT01085097|BG002|Baseline|Laquinimod 1 mg|Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380252|NCT01085097|BG003|Baseline|Total|Total of all reporting groups
11380253|NCT01085097|FG000|Participant Flow|Placebo|Participants received 2 capsules of placebo matched to laquinimod orally once daily (QD) for 24 weeks, mycophenolate mofetil (MMF) 500 milligrams (mg) tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and methylprednisolone (MP) 500 mg/day intravenously(IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380254|NCT01085097|FG001|Participant Flow|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380255|NCT01085097|FG002|Participant Flow|Laquinimod 1 mg|Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380256|NCT01085097|OG000|Outcome|Placebo|Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380257|NCT01085097|OG001|Outcome|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380258|NCT01085097|OG002|Outcome|Laquinimod 1 mg|Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380259|NCT01085097|EG000|Reported Event|Placebo|Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380260|NCT01085097|EG001|Reported Event|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380261|NCT01085097|EG002|Reported Event|Laquinimod 1 mg|Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
11380262|NCT00920621|BG000|Baseline|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
11380263|NCT00920621|BG001|Baseline|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380264|NCT00920621|BG002|Baseline|Vitamin D Treatment (Children)|Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
10781295|NCT04098497|OG000|Outcome|ACT-based Microintervention Delivered by Mobile App|"The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.~Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.~Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
11193770|NCT02147587|EG000|Reported Event|Placebo Twice a Day|Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
11380265|NCT00920621|BG003|Baseline|Placebo (Children)|"Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380266|NCT00920621|BG004|Baseline|Total|Total of all reporting groups
11380267|NCT00920621|FG000|Participant Flow|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
11380268|NCT00920621|FG001|Participant Flow|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380269|NCT00920621|FG002|Participant Flow|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
11380270|NCT00920621|FG003|Participant Flow|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control"
11380271|NCT00920621|OG000|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
11380272|NCT00920621|OG001|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
11380273|NCT00920621|OG000|Outcome|Vitamin D Treatment|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
11380274|NCT00920621|OG001|Outcome|Placebo|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380275|NCT00920621|OG001|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D
11380276|NCT00920621|EG000|Reported Event|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
11380277|NCT00920621|EG001|Reported Event|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380278|NCT00920621|EG002|Reported Event|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
11380279|NCT00920621|EG003|Reported Event|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
11380280|NCT00828308|BG000|Baseline|Ixabepilone|Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
11380281|NCT00828308|FG000|Participant Flow|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
11380282|NCT00828308|OG000|Outcome|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
11380283|NCT00828308|EG000|Reported Event|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
11380284|NCT00680901|BG000|Baseline|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380285|NCT00680901|BG001|Baseline|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380286|NCT00680901|BG002|Baseline|Total|Total of all reporting groups
11380287|NCT00680901|FG000|Participant Flow|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380288|NCT00680901|FG001|Participant Flow|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380289|NCT00680901|OG000|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
10781296|NCT04098497|EG000|Reported Event|ACT-based Microintervention Delivered by Mobile App|"The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.~Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.~Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
10781297|NCT03945825|BG000|Baseline|Fluzone|0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781298|NCT03945825|BG001|Baseline|Fluzone + AF03|0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781299|NCT03945825|BG002|Baseline|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL of 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781300|NCT03945825|BG003|Baseline|Flublok|0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781301|NCT03945825|BG004|Baseline|Flublok + AF03|0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781302|NCT03945825|BG005|Baseline|Flublok + CpG55|0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781303|NCT03945825|BG006|Baseline|Total|Total of all reporting groups
10781304|NCT03945825|FG000|Participant Flow|Fluzone|"0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.~Influenza Virus Quadrivalent Inactivated Vaccine: unadjuvanted 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval"
10781305|NCT03945825|FG001|Participant Flow|Fluzone + AF03|"0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.~AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether~Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval"
10781306|NCT03945825|FG002|Participant Flow|Fluzone + CpG55|"0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL 2019/2020 of Fluzone QIV intramuscular injection on Day 90.~Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)~Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval"
10781307|NCT03945825|FG003|Participant Flow|Flublok|"0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~Quadrivalent Recombinant Seasonal Influenza Vaccine: unadjuvanted 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval"
10781308|NCT03945825|FG004|Participant Flow|Flublok + AF03|"0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether~Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval"
10781309|NCT03945825|FG005|Participant Flow|Flublok + CpG55|"0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)~Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval"
10781310|NCT03945825|OG000|Outcome|Fluzone|0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781311|NCT03945825|OG001|Outcome|Fluzone + AF03|0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781312|NCT03945825|OG002|Outcome|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL of 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781313|NCT03945825|OG003|Outcome|Flublok|"0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses."
10781314|NCT03945825|OG004|Outcome|Flublok + AF03|"0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses."
10781315|NCT03945825|OG005|Outcome|Flublok + CpG55|0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
11193771|NCT02147587|EG001|Reported Event|Tofacitinib 5 mg Twice a Day|Following administration of zoster vaccine to RA participants receiving background methotrexate, participants received tofacitinib 5 mg twice a day orally for up to 12 weeks.
10781316|NCT03945825|OG005|Outcome|Flublok + CpG55|0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL of of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781317|NCT03945825|OG003|Outcome|Flublok|0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781318|NCT03945825|OG004|Outcome|Flublok + AF03|0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781319|NCT03945825|OG000|Outcome|Fluzone + AF03|0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781320|NCT03945825|OG001|Outcome|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL of 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781321|NCT03945825|OG002|Outcome|Flublok + AF03|0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781322|NCT03945825|OG003|Outcome|Flublok + CpG55|0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781323|NCT03945825|OG002|Outcome|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781324|NCT03945825|OG001|Outcome|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781325|NCT03945825|EG000|Reported Event|Fluzone|0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781326|NCT03945825|EG001|Reported Event|Fluzone + AF03|0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
10781327|NCT03945825|EG002|Reported Event|Fluzone + CpG55|0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
10781328|NCT03945825|EG003|Reported Event|Flublok|"0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses."
10781329|NCT03945825|EG004|Reported Event|Flublok + AF03|"0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.~One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses."
10781330|NCT03945825|EG005|Reported Event|Flublok + CpG55|0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
10781331|NCT03937141|BG000|Baseline|ADU-S100 and Pembrolizumab|"All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.~ADU-S100: intratumoral"
10781332|NCT03937141|FG000|Participant Flow|ADU-S100 and Pembrolizumab|"All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.~ADU-S100: intratumoral"
10781333|NCT03937141|OG000|Outcome|ADU-S100 and Pembrolizumab|"All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.~ADU-S100: intratumoral"
10781334|NCT03937141|EG000|Reported Event|ADU-S100 and Pembrolizumab|"All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.~ADU-S100: intratumoral"
10781335|NCT03678402|BG000|Baseline|Palarum Fall Prevention System|"The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.~PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data."
10781336|NCT03678402|FG000|Participant Flow|Palarum Fall Prevention System|"The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.~PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data."
10803739|NCT02255656|EG000|Reported Event|Delayed Alemtuzumab Treatment (DAT)|Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
10781337|NCT03678402|OG000|Outcome|Palarum Fall Prevention System|"The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.~PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data."
10781338|NCT03678402|EG000|Reported Event|Palarum Fall Prevention System|"The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.~PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data."
10781339|NCT03641937|BG000|Baseline|INVSENSOR00011 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.~INVSENSOR00011: investigational sensor that will be placed on the subject's chest and/or back for the duration of the study."
10781340|NCT03641937|FG000|Participant Flow|INVSENSOR00011 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.~INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study."
10781341|NCT03641937|OG000|Outcome|INVSENSOR00011 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.~INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study."
10781342|NCT03641937|EG000|Reported Event|INVSENSOR00011 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.~INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study."
10781343|NCT03572244|BG000|Baseline|Laser-Lok|"A Laser-Lok microgrooved implant will be placed.~Laser-Lok: A microgrooved abutment will be placed"
10781344|NCT03572244|BG001|Baseline|Machine|"A machined implant will be placed.~Machined: A machined transmucosal healing abutment will be placed"
10781345|NCT03572244|BG002|Baseline|Total|Total of all reporting groups
10781346|NCT03572244|FG000|Participant Flow|Laser-Lok|"A Laser-Lok microgrooved implant will be placed.~Laser-Lok: A microgrooved abutment will be placed"
10781347|NCT03572244|FG001|Participant Flow|Machine|"A machined implant will be placed.~Machined: A machined transmucosal healing abutment will be placed"
10781348|NCT03572244|OG000|Outcome|Laser-Lok|"A Laser-Lok microgrooved implant will be placed.~Laser-Lok: A microgrooved abutment will be placed"
10781349|NCT03572244|OG001|Outcome|Machine|"A machined implant will be placed.~Machined: A machined transmucosal healing abutment will be placed"
10781350|NCT03572244|EG000|Reported Event|Laser-Lok|"A Laser-Lok microgrooved implant will be placed.~Laser-Lok: A microgrooved abutment will be placed"
10781351|NCT03572244|EG001|Reported Event|Machine|"A machined implant will be placed.~Machined: A machined transmucosal healing abutment will be placed"
10781352|NCT03562767|BG000|Baseline|Group-based Cognitive Behavioral Intervention|"Subjects receiving the group-based CT-CB intervention~Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support."
10781353|NCT03562767|BG001|Baseline|Web-based Cognitive Behavioral Intervention|"Subjects receiving the web based CT-CB intervention~Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities."
10781354|NCT03562767|BG002|Baseline|Usual Care|"Subjects receiving usual care from their primary care providers~Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed."
10781355|NCT03562767|BG003|Baseline|Total|Total of all reporting groups
10781356|NCT03562767|FG000|Participant Flow|Group-based Cognitive Behavioral Intervention|"Subjects receiving the group-based CT-CB intervention~Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support."
10850610|NCT00303602|FG000|Participant Flow|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
10850611|NCT00303602|FG001|Participant Flow|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
10781357|NCT03562767|FG001|Participant Flow|Web-based Cognitive Behavioral Intervention|"Subjects receiving the web based CT-CB intervention~Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities."
10781358|NCT03562767|FG002|Participant Flow|Usual Care|"Subjects receiving usual care from their primary care providers~Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed."
10781359|NCT03562767|OG000|Outcome|Group-based Cognitive Behavioral Intervention|"Subjects receiving the group-based CT-CB intervention~Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support."
10781360|NCT03562767|OG001|Outcome|Web-based Cognitive Behavioral Intervention|"Subjects receiving the web based CT-CB intervention~Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities."
10781361|NCT03562767|OG002|Outcome|Usual Care|"Subjects receiving usual care from their primary care providers~Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed."
10781362|NCT03562767|OG000|Outcome|Group-based Cognitive Behavioral Intervention|Subjects receiving the group-based CT-CBintervention Group-based CognitiveBehavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
10781363|NCT03562767|OG001|Outcome|Web-based Cognitive Behavioral Intervention|Subjects receiving the web-based CT-CBintervention Web-based CognitiveBehavioralIntervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1hour period for a web call from the behavioral interventionist team. Text reminders will be sent to the participants prior to the sessions. During this period, approximately 15minutes will be reserved for diabetes exercise and food planning education and approximately 45minutes of CT-CBengagement activities.
10781364|NCT03562767|OG000|Outcome|Group-based or Web-based Cognitive Behavioral Intervention|Participants from both study arms are combined for this analysis.
10781365|NCT03562767|OG001|Outcome|Web-based Cognitive Behavioral Intervention|"Subjects receiving the web-based CT-CB intervention~Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior to the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities."
10781366|NCT03562767|EG000|Reported Event|Group-based Cognitive Behavioral Intervention|"Subjects receiving the group-based CT-CB intervention~Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support."
10781367|NCT03562767|EG001|Reported Event|Web-based Cognitive Behavioral Intervention|"Subjects receiving the web based CT-CB intervention~Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities."
10781368|NCT03562767|EG002|Reported Event|Usual Care|"Subjects receiving usual care from their primary care providers~Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed."
10781369|NCT03559699|BG000|Baseline|AG-348|Participants received AG-348 tablets, administered orally, at a starting dose of 5 mg, BID, followed by two sequential dose level increases to 20 mg and 50 mg BID, for a period of 16 weeks in Part 1. This was followed by optimized dose BID, as determined by the investigator in Part 1, for a period of 24 weeks in Part 2.
10850612|NCT00303602|OG000|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
11243318|NCT02502149|OG000|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
10781370|NCT03559699|FG000|Participant Flow|AG-348|Participants received AG-348 tablets, administered orally, at a starting dose of 5 milligrams (mg), twice daily (BID), followed by two sequential dose level increases to 20 mg and 50 mg BID, for a period of 16 weeks in Part 1. This was followed by optimized dose BID, as determined by the investigator in Part 1, for a period of 24 weeks in Part 2.
10781371|NCT03559699|OG000|Outcome|AG-348|Participants received AG-348 tablets, administered orally, at a starting dose of 5 mg, BID, followed by two sequential dose level increases to 20 mg and 50 mg BID, for a period of 16 weeks in Part 1. This was followed by optimized dose BID, as determined by the investigator in Part 1, for a period of 24 weeks in Part 2.
10850613|NCT00303602|OG001|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
11193772|NCT02147613|BG000|Baseline|High Intensity Interval Training|"High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)~High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)"
11380290|NCT00680901|OG001|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380291|NCT00680901|EG000|Reported Event|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380292|NCT00680901|EG001|Reported Event|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
11380293|NCT00667251|BG000|Baseline|Lapatinib|
11380294|NCT00667251|BG001|Baseline|Trastuzumab|
11380295|NCT00667251|BG002|Baseline|Total|Total of all reporting groups
11380296|NCT00667251|FG000|Participant Flow|Lapatinib|Lapatinib - 1250 mg po daily Taxane based chemotherapy: Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards. Followed by: Lapatinib - 1500 mg po daily until disease progression.
11380297|NCT00667251|FG001|Participant Flow|Trastuzumab|Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle) Followed by: Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression.
11380298|NCT00667251|OG000|Outcome|Lapatinib|Plus taxane based chemotherapy
11380299|NCT00667251|OG001|Outcome|Trastuzumab|Plus taxane based chemotherapy.
11380300|NCT00667251|EG000|Reported Event|Lapatinib|Plus taxane based chemotherapy
11380301|NCT00667251|EG001|Reported Event|Trastuzumab|Plus taxane based chemotherapy.
11380302|NCT00600015|BG000|Baseline|Combination Therapy|sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
11380303|NCT00600015|BG001|Baseline|Placebo|Placebo twice daily orally plus erlotinib (150 mg orally daily)
11380304|NCT00600015|BG002|Baseline|Total|Total of all reporting groups
11380305|NCT00600015|FG000|Participant Flow|Combination Therapy|sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
11193773|NCT02147613|BG001|Baseline|Moderate Intensity Exercise Training|"3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)~Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)"
11380306|NCT00600015|FG001|Participant Flow|Placebo|Placebo twice daily orally plus erlotinib (150 mg orally daily)
11380307|NCT00600015|OG000|Outcome|Combination Therapy|sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
11380308|NCT00600015|OG001|Outcome|Placebo|Placebo twice daily orally plus erlotinib (150 mg orally daily)
11380309|NCT00600015|OG000|Outcome|Combination Therapy|Erlotinib + Sorafenib
11380310|NCT00600015|OG001|Outcome|Placebo|Erlotinib + Placebo
11380311|NCT00600015|EG000|Reported Event|All Study Participants|"Reported SAEs and AEs for all study participants -~Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo"
11380312|NCT00500071|BG000|Baseline|Vyvanse|Lisdexamfetamine dimesylate (LDX)
11380313|NCT00500071|FG000|Participant Flow|Vyvanse|Lisdexamfetamine dimesylate (LDX)
11380314|NCT00500071|OG000|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
11380315|NCT00500071|EG000|Reported Event|Vyvanse|Lisdexamfetamine dimesylate (LDX)
11380316|NCT00447122|BG000|Baseline|Arm 1|Gemcitabine, 1000mg/m2 and lapatinib 1000mg/d
11380317|NCT00447122|BG001|Baseline|Arm 2|Gemcitabine, 1000mg/m2 and lapatinib 1500mg/d
11193774|NCT02147613|BG002|Baseline|Total|Total of all reporting groups
11193775|NCT02147613|FG000|Participant Flow|High Intensity Interval Training|"High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)~High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)"
11380318|NCT00447122|BG002|Baseline|Arm 3|Gemcitabine, 1000mg/m2 over 100minutes lapatinib 1000mg/d oxaliplatin 100mg/m2
11380319|NCT00447122|BG003|Baseline|Arm 4|Gemcitabine, 1000mg/m2 over 100minutes lapatinib 1500mg/d oxaliplatin 100mg/m2
11380320|NCT00447122|BG004|Baseline|Total|Total of all reporting groups
11380321|NCT00447122|FG000|Participant Flow|Arm 1|lapatinib, 1,000 mg/day, and Gemcitabine, 1000mg/m2
11380322|NCT00447122|FG001|Participant Flow|Arm 2|Gem 1000mg/m2, lapatinib 1500mg/d
11380323|NCT00447122|FG002|Participant Flow|Arm 3|Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1000mg/d
11380324|NCT00447122|FG003|Participant Flow|Arm 4|Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1500mg/d
11380325|NCT00447122|OG000|Outcome|Arm 1|Gem 1000mg/m2 lapatinib 1000mg/d
11380326|NCT00447122|OG001|Outcome|Arm 2|Gem 1000mg/m2 lapatinib 1500mg/d
11380327|NCT00447122|OG002|Outcome|Arm 3|Gem 1000mg/m2 lapatinib 1000mg/d oxaliplatin 100mg/m2
11380328|NCT00447122|OG003|Outcome|Arm 4|Gem 1000mg/m2 lapatinib 1500mg/d oxaliplatin 100mg/m2
11380329|NCT00447122|EG000|Reported Event|Arm 1|Gem 1000mg/m2 lapatinib 1000mg/d
11380330|NCT00447122|EG001|Reported Event|Arm 2|Gem 1000mg/m2 lapatinib 1500mg/d
11380331|NCT00447122|EG002|Reported Event|Arm 3|Gem 1000mg/m2 lapatinib 1000mg/d oxaliplatin 100mg/m2
11380332|NCT00447122|EG003|Reported Event|Arm 4|Gem 1000mg/m2 lapatinib 1500mg/d oxaliplatin 100mg/m2
11380333|NCT00382252|BG000|Baseline|18F-FDG PET/CT + RFA|"18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.~RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.~CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.~computed tomography~positron emission tomography~radiofrequency ablation"
11380334|NCT00382252|FG000|Participant Flow|18F-FDG PET/CT + RFA|"18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.~RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.~CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.~computed tomography~positron emission tomography~radiofrequency ablation"
11380335|NCT00382252|OG000|Outcome|18F-FDG PET/CT + RFA|"18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.~RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.~CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.~computed tomography~positron emission tomography~radiofrequency ablation"
11380336|NCT00382252|EG000|Reported Event|18F-FDG PET/CT + RFA|"18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.~RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.~CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.~computed tomography~positron emission tomography~radiofrequency ablation"
11380337|NCT00324805|BG000|Baseline|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380338|NCT00324805|BG001|Baseline|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380339|NCT00324805|BG002|Baseline|Total|Total of all reporting groups
10781372|NCT03559699|EG000|Reported Event|AG-348|Participants received AG-348 tablets, administered orally, at a starting dose of 5 mg, BID, followed by two sequential dose level increases to 20 mg and 50 mg BID, for a period of 16 weeks in Part 1. This was followed by optimized dose BID, as determined by the investigator in Part 1, for a period of 24 weeks in Part 2.
10801542|NCT03529773|BG025|Baseline|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801543|NCT03529773|BG026|Baseline|Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801544|NCT03529773|BG027|Baseline|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801545|NCT03529773|BG028|Baseline|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801546|NCT03529773|BG029|Baseline|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801547|NCT03529773|BG030|Baseline|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801548|NCT03529773|BG031|Baseline|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801549|NCT03529773|BG032|Baseline|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801550|NCT03529773|BG033|Baseline|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801551|NCT03529773|BG034|Baseline|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801552|NCT03529773|BG035|Baseline|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10803740|NCT02255656|EG001|Reported Event|Initial Alemtuzumab Treatment (IAT)|Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
11380340|NCT00324805|FG000|Participant Flow|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 intravenously (IV) on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11193776|NCT02147613|FG001|Participant Flow|Moderate Intensity Exercise Training|"3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)~Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)"
10781373|NCT03333057|BG000|Baseline|NOV03 2 Times Daily (BID)|"Perfluorohexyloctance solution 2 times daily (BID)~NOV03: Perfluorohexyloctane"
10781374|NCT03333057|BG001|Baseline|NOV03 4 Times Daily (QID)|"Perfluorohexyloctance solution 4 times daily~NOV03: Perfluorohexyloctane"
10781375|NCT03333057|BG002|Baseline|Placebo BID/QID|"Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)~Placebo: Saline solution (0.9% sodium chloride solution)"
10781376|NCT03333057|BG003|Baseline|Total|Total of all reporting groups
10781377|NCT03333057|FG000|Participant Flow|NOV03 2 Times Daily (BID)|"Perfluorohexyloctance solution 2 times daily (BID)~NOV03: Perfluorohexyloctane"
10781378|NCT03333057|FG001|Participant Flow|NOV03 4 Times Daily (QID)|"Perfluorohexyloctance solution 4 times daily~NOV03: Perfluorohexyloctane"
10781379|NCT03333057|FG002|Participant Flow|Placebo BID/QID|"Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)~Placebo: Saline solution (0.9% sodium chloride solution)"
10781380|NCT03333057|OG000|Outcome|NOV03 2 Times Daily (BID)|"Perfluorohexyloctance solution 2 times daily (BID)~NOV03: Perfluorohexyloctane"
10781381|NCT03333057|OG001|Outcome|NOV03 4 Times Daily (QID)|"Perfluorohexyloctance solution 4 times daily~NOV03:Perfluorohexyloctane"
10781382|NCT03333057|OG002|Outcome|Placebo BID/QID|"Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)~Placebo: Saline solution (0.9% sodium chloride solution)"
10781383|NCT03333057|EG000|Reported Event|NOV03 2 Times Daily (BID)|"Perfluorohexyloctance solution 2 times daily (BID)~NOV03: Perfluorohexyloctane"
10781384|NCT03333057|EG001|Reported Event|NOV03 4 Times Daily (QID)|"Perfluorohexyloctance solution 4 times daily~NOV03: Perfluorohexyloctane"
10781385|NCT03333057|EG002|Reported Event|Placebo BID/QID|"Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)~Placebo: Saline solution (0.9% sodium chloride solution)"
10781386|NCT03305016|BG000|Baseline|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH) at a starting dose of 0.24 mg/kg/week
10781387|NCT03305016|FG000|Participant Flow|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH) at a starting dose of 0.24 mg/kg/week
10781388|NCT03305016|OG000|Outcome|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH) at a starting dose of 0.24 mg/kg/week
10781389|NCT03305016|EG000|Reported Event|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH) at a starting dose of 0.24 mg/kg/week
10781390|NCT03300336|BG000|Baseline|Intervention|"Implementation of STRIDE program~STRIDE: Implementation of STRIDE inpatient hospital mobility program"
10781391|NCT03300336|BG001|Baseline|Usual Care|Pre-implementation before STRIDE program
10781392|NCT03300336|BG002|Baseline|Total|Total of all reporting groups
10781393|NCT03300336|FG000|Participant Flow|Intervention|"Implementation of STRIDE program~STRIDE: Implementation of STRIDE inpatient hospital mobility program"
10781394|NCT03300336|FG001|Participant Flow|Usual Care|Pre-implementation before STRIDE program
10781395|NCT03300336|OG000|Outcome|Intervention|"Implementation of STRIDE program~STRIDE: Implementation of STRIDE inpatient hospital mobility program"
10781396|NCT03300336|OG001|Outcome|Usual Care|Pre-implementation before STRIDE program
10781397|NCT03300336|EG000|Reported Event|Intervention|"Implementation of STRIDE program~STRIDE: Implementation of STRIDE inpatient hospital mobility program"
10781398|NCT03300336|EG001|Reported Event|Usual Care|Pre-implementation before STRIDE program
10781399|NCT03291067|BG000|Baseline|MT-8554 1mg|MT-8554 1mg QD, oral, 12 weeks
10781400|NCT03291067|BG001|Baseline|MT-8554 5mg|MT-8554 5mg QD, oral, 12 weeks
10781401|NCT03291067|BG002|Baseline|MT-8554 10mg|MT-8554 10mg QD, oral, 12 weeks
10781402|NCT03291067|BG003|Baseline|Placebo|Placebo QD, oral, 12 weeks
10781403|NCT03291067|BG004|Baseline|Total|Total of all reporting groups
10781404|NCT03291067|FG000|Participant Flow|MT-8554 1mg|MT-8554 1mg QD, oral, 12 weeks
10781405|NCT03291067|FG001|Participant Flow|MT-8554 5mg|MT-8554 5mg QD, oral, 12 weeks
10781406|NCT03291067|FG002|Participant Flow|MT-8554 10mg|MT-8554 10mg QD, oral, 12 weeks
10781407|NCT03291067|FG003|Participant Flow|Placebo|Placebo QD, oral, 12 weeks
10781408|NCT03291067|OG000|Outcome|MT-8554 1mg|MT-8554 1mg QD, oral, 12 weeks
10781409|NCT03291067|OG001|Outcome|MT-8554 5mg|MT-8554 5mg QD, oral, 12 weeks
10781410|NCT03291067|OG002|Outcome|MT-8554 10mg|MT-8554 10mg QD, oral, 12 weeks
10781411|NCT03291067|OG003|Outcome|Placebo|Placebo QD, oral, 12 weeks
10781412|NCT03291067|EG000|Reported Event|MT-8554 1mg|MT-8554 1mg QD, oral, 12 weeks
10781413|NCT03291067|EG001|Reported Event|MT-8554 5mg|MT-8554 5mg QD, oral, 12 weeks
10781414|NCT03291067|EG002|Reported Event|MT-8554 10mg|MT-8554 10mg QD, oral, 12 weeks
10781415|NCT03291067|EG003|Reported Event|Placebo|Placebo QD, oral, 12 weeks
10781416|NCT03271047|BG000|Baseline|Phase 1b: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781417|NCT03271047|BG001|Baseline|Phase 1b: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10850614|NCT00303602|EG000|Reported Event|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
10850615|NCT00303602|EG001|Reported Event|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
11243319|NCT02502149|OG001|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 or 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
11380341|NCT00324805|FG001|Participant Flow|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380342|NCT00324805|OG000|Outcome|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380343|NCT00324805|OG001|Outcome|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380344|NCT00324805|EG000|Reported Event|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380345|NCT00324805|EG001|Reported Event|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
11380346|NCT00310180|BG000|Baseline|Arm A|"Group 1 (Oncotype DX recurrence score =< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380347|NCT00310180|BG001|Baseline|Arm B|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380348|NCT00310180|BG002|Baseline|Arm C|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380349|NCT00310180|BG003|Baseline|Arm D|"Group 3 (Oncotype DX recurrence score >= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380350|NCT00310180|BG004|Baseline|Total|Total of all reporting groups
11380351|NCT00310180|FG000|Participant Flow|Arm A|"Group 1 (Oncotype DX recurrence score =< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380352|NCT00310180|FG001|Participant Flow|Arm B|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380353|NCT00310180|FG002|Participant Flow|Arm C|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380354|NCT00310180|FG003|Participant Flow|Arm D|"Group 3 (Oncotype DX recurrence score >= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380355|NCT00310180|OG000|Outcome|Arm A|"Group 1 (Oncotype DX recurrence score =< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380356|NCT00310180|OG001|Outcome|Arm B|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380357|NCT00310180|OG002|Outcome|Arm C|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380358|NCT00310180|OG003|Outcome|Arm D|"Group 3 (Oncotype DX recurrence score >= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380359|NCT00310180|EG000|Reported Event|Arm A|"Group 1 (Oncotype DX recurrence score =< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380360|NCT00310180|EG001|Reported Event|Arm B|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO"
11380361|NCT00310180|EG002|Reported Event|Arm C|"Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380362|NCT00310180|EG003|Reported Event|Arm D|"Group 3 (Oncotype DX recurrence score >= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment.~Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO~Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials"
11380363|NCT00309985|BG000|Baseline|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11380364|NCT00309985|BG001|Baseline|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
11380365|NCT00309985|BG002|Baseline|Total|Total of all reporting groups
11380366|NCT00309985|FG000|Participant Flow|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11380367|NCT00309985|FG001|Participant Flow|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
11380368|NCT00309985|OG000|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11380369|NCT00309985|OG001|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
11380370|NCT00309985|EG000|Reported Event|Arm A|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11380371|NCT00309985|EG001|Reported Event|Arm B|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
11380372|NCT00290251|BG000|Baseline|Placebo|All women who received placebo
11380373|NCT00290251|BG001|Baseline|Ulipristal Acetate 10 mg|All women who received Ulipristal Acetate - 20 mg
11380374|NCT00290251|BG002|Baseline|Ulipristal Acetate 20 mg|All women who received Ulipristal Acetate - 20 mg
11380375|NCT00290251|BG003|Baseline|Total|Total of all reporting groups
10781418|NCT03271047|BG002|Baseline|Phase 2: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781419|NCT03271047|BG003|Baseline|Phase 2: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781420|NCT03271047|BG004|Baseline|Total|Total of all reporting groups
10781421|NCT03271047|FG000|Participant Flow|Phase 1b: Nivolumab+Binimetinib|Participants with previously treated microsatellite-stable (MSS) metastatic colorectal cancer with rat sarcoma virus (RAS) mutation received binimetinib at a starting dose of 45 milligrams (mg) tablet orally twice daily (BID) along with 480 mg intravenously (IV) dose of nivolumab every 4 weeks in each 28 day treatment cycle. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781422|NCT03271047|FG001|Participant Flow|Phase 1b: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 milligram per kilogram (mg/kg) IV every 8 weeks after completion of nivolumab infusion. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781423|NCT03271047|FG002|Participant Flow|Phase 2: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781424|NCT03271047|FG003|Participant Flow|Phase 2: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781425|NCT03271047|OG000|Outcome|Phase 1b: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781426|NCT03271047|OG001|Outcome|Phase 1b: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781427|NCT03271047|OG000|Outcome|Phase 2: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781428|NCT03271047|OG001|Outcome|Phase 2: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781429|NCT03271047|OG002|Outcome|Phase 2: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781430|NCT03271047|OG003|Outcome|Phase 2: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
11380376|NCT00290251|FG000|Participant Flow|Pre-ulipristal Acetate - 20 mg|Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group
11380377|NCT00290251|FG001|Participant Flow|Pre-ulipristal Acetate 10 mg|Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group
11380378|NCT00290251|FG002|Participant Flow|Pre-placebo|Women received no intervention for one menstrual cycle before entering placebo group
11380379|NCT00290251|FG003|Participant Flow|Ulipristal Acetate - 20 mg|Women received ulipristal acetate 20 mg/d
11380380|NCT00290251|FG004|Participant Flow|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
11380381|NCT00290251|FG005|Participant Flow|Placebo (PLC)|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
11380382|NCT00290251|OG000|Outcome|Ulipristal Acetate -20mg|Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.
11380383|NCT00290251|OG001|Outcome|Ulipristal Acetate - 10 mg|Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.
11380384|NCT00290251|OG002|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
11380385|NCT00290251|OG000|Outcome|Ulipristal Acetate -10 and 20mg|Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.
11380386|NCT00290251|OG001|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
11380387|NCT00290251|EG000|Reported Event|Ulipristal Acetate -20mg|Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
11380388|NCT00290251|EG001|Reported Event|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
11380389|NCT00290251|EG002|Reported Event|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
11380390|NCT00290251|EG003|Reported Event|Pre-Ulipristal Acetate 20 mg|Women charted symptoms for one menstrual cycle before entering ulipristal acetate 20 mg group
11380391|NCT00290251|EG004|Reported Event|Pre-Ulipristal Acetate- 10 mg|Women charted symptoms for one menstrual cycle before entering ulipristal acetate 10 mg group
11380392|NCT00290251|EG005|Reported Event|Pre-Placebo|Women charted symptoms for one menstrual cycle before entering placebo group
11380393|NCT00066963|BG000|Baseline|No Intervention: Counseling Only|Counseling Only (0FV)
11380394|NCT00066963|BG001|Baseline|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
11380395|NCT00066963|BG002|Baseline|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
11380396|NCT00066963|BG003|Baseline|Total|Total of all reporting groups
11380397|NCT00066963|FG000|Participant Flow|No Intervention: Counseling Only|Counseling Only (0FV)
11380398|NCT00066963|FG001|Participant Flow|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
11380399|NCT00066963|FG002|Participant Flow|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
11380400|NCT00066963|OG000|Outcome|Counseling Only|caregiver counseling only (zero fluoride varnish)
11380401|NCT00066963|OG001|Outcome|FV 1x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
11380402|NCT00066963|OG002|Outcome|FV 2x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
11380403|NCT00066963|EG000|Reported Event|No Intervention: Counseling Only|Counseling Only (0FV)
11380404|NCT00066963|EG001|Reported Event|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
11380405|NCT00066963|EG002|Reported Event|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
11380406|NCT01403948|BG000|Baseline|BI 836826 1 mg iv (Caucasian Patients)|"BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380407|NCT01403948|BG001|Baseline|BI 836826 3 mg iv (Caucasian Patients)|"BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380408|NCT01403948|BG002|Baseline|BI 836826 9 mg iv (Caucasian Patients)|"BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380409|NCT01403948|BG003|Baseline|BI 836826 25 mg iv (Caucasian Patients)|"BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380410|NCT01403948|BG004|Baseline|BI 836826 50 mg iv (Caucasian Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380411|NCT01403948|BG005|Baseline|BI 836826 50mg iv (Korean Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380412|NCT01403948|BG006|Baseline|BI 836826 100 mg iv (Caucasian Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380413|NCT01403948|BG007|Baseline|BI 836826 100 mg iv (Korean Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380414|NCT01403948|BG008|Baseline|BI 836826 150 mg iv (Caucasian Patients)|"BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380415|NCT01403948|BG009|Baseline|BI 836826 200 mg iv (Caucasian Patients)|"BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380416|NCT01403948|BG010|Baseline|Total|Total of all reporting groups
11380417|NCT01403948|FG000|Participant Flow|BI 836826 1 mg iv (Caucasian Patients)|"BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380418|NCT01403948|FG001|Participant Flow|BI 836826 3 mg iv (Caucasian Patients)|"BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
10781431|NCT03271047|EG000|Reported Event|Phase 1b: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781432|NCT03271047|EG001|Reported Event|Phase 1b: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days.
10781433|NCT03271047|EG002|Reported Event|Phase 2: Nivolumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781434|NCT03271047|EG003|Reported Event|Phase 2: Nivolumab+Ipilimumab+Binimetinib|Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days.
10781435|NCT03257436|BG000|Baseline|Single Arm|"General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.~CRT-D: Left Ventricular MultiSite Pacing"
10781436|NCT03257436|FG000|Participant Flow|Single Arm|"General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.~CRT-D: Left Ventricular MultiSite Pacing"
10781437|NCT03257436|OG000|Outcome|Single Arm|"General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.~CRT-D: Left Ventricular MultiSite Pacing"
10781438|NCT03257436|EG000|Reported Event|Single Arm|General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
10781439|NCT03171480|BG000|Baseline|Monoket Pill|"Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781440|NCT03171480|BG001|Baseline|Placebo Pill|"The pharmacy has compounded an identical appearing placebo~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781441|NCT03171480|BG002|Baseline|Total|Total of all reporting groups
10781442|NCT03171480|FG000|Participant Flow|Monoket Pill|"Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781443|NCT03171480|FG001|Participant Flow|Placebo|"The pharmacy has compounded an identical appearing placebo~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781444|NCT03171480|OG000|Outcome|Monoket Pill|"Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781445|NCT03171480|OG001|Outcome|Placebo|"The pharmacy has compounded an identical appearing placebo~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781446|NCT03171480|OG001|Outcome|Placebo Pill|"The pharmacy has compounded an identical appearing placebo~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781447|NCT03171480|EG000|Reported Event|Monoket Pill|"Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781448|NCT03171480|EG001|Reported Event|Placebo|"The pharmacy has compounded an identical appearing placebo~Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor"
10781449|NCT03158285|BG000|Baseline|Placebo to Guselkumab 100 mg q4w|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.
10781450|NCT03158285|BG001|Baseline|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.
10781451|NCT03158285|BG002|Baseline|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
10781452|NCT03158285|BG003|Baseline|Total|Total of all reporting groups
10781453|NCT03158285|FG000|Participant Flow|Placebo to Guselkumab 100 mg q4w|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.
10781454|NCT03158285|FG001|Participant Flow|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.
10781455|NCT03158285|FG002|Participant Flow|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
10781456|NCT03158285|OG000|Outcome|Placebo to Guselkumab 100 mg q4w|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period.
10781457|NCT03158285|OG001|Outcome|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.
10781458|NCT03158285|OG002|Outcome|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
10781459|NCT03158285|OG000|Outcome|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100.
10781460|NCT03158285|OG001|Outcome|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100.
10781461|NCT03158285|EG000|Reported Event|Placebo (CP)|Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP). Data prior to the first administration of guselkumab, or through the last follow-up visit if the participant did not receive any guselkumab, were included.
10781462|NCT03158285|EG001|Reported Event|Guselkumab 100 mg q8w (CP)|Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.
10781463|NCT03158285|EG002|Reported Event|Guselkumab 100 mg q4w (CP)|Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.
10781464|NCT03158285|EG003|Reported Event|Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)|Participants who received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP) received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 24 through Week 100. Data from the first administration of guselkumab through Week 112 (End of Study) were included.
10781465|NCT03158285|EG004|Reported Event|Guselkumab 100 mg q8w (Through Week 112)|Participants received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 0 and 4 then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 100. Data from Week 0 through Week 112 (End of Study) were included.
10781466|NCT03158285|EG005|Reported Event|Guselkumab 100 mg q4w (Through Week 112)|Participants received guselkumab 100 milligram (mg) subcutaneous injections every 4 weeks from Week 0 through Week 100. Data from Week 0 through Week 112 (End of Study) were included.
10801553|NCT03529773|BG036|Baseline|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801554|NCT03529773|BG037|Baseline|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801555|NCT03529773|BG038|Baseline|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10850905|NCT03999554|FG002|Participant Flow|High Dose Sing2016 M2SR|"High dose Sing2016 M2SR will be administered intranasally on days 1 and 29~HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10781467|NCT04723173|BG000|Baseline|Study Population|This was a crossover design, in which all participants undertook the same conditions.
10781468|NCT04723173|FG000|Participant Flow|Study Population|"This was a crossover design, in which all participants undertook the same conditions.~The conditions (different hearing aid settings) were completed in a randomized order during a single study appointment. Therefore the number starting each period will not match the number completing the previous period.~The study started with 10 participants in total. Single tests (test period 2 and 3) started just with 9 participants, because there was 1 withdrawal. Test period 2 were completed with 1 participant less, than test period 3 started. That was possible, because the tests were independent and 1 participant was not able to perform the test is period 2, but was able to perform the test in period 3."
10781469|NCT04723173|OG000|Outcome|Noise Reduction on|"The noise reduction is activated. The feature shall support the hearing aid user in noisy situations and shall reduce the listening effort in these special situations.~Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.~Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary."
10781470|NCT04723173|OG001|Outcome|Noise Reduction Off|"To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.~Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.~Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary."
10781471|NCT04723173|OG000|Outcome|Evaluation of Sound Quality Without Increasing Gain|All participants had to evaluate the sound quality with the standard fitting of the feedback manager.
10781472|NCT04723173|OG001|Outcome|Evaluation of Sound Quality With Increasing Gain|All participants had to evaluate the sound quality with additional gain, enabled by the feedback manager.
10781473|NCT04723173|OG000|Outcome|Feature for Soft Noise on|A threshold was measured with activated feature.
10781474|NCT04723173|OG001|Outcome|Feature for Soft Noise Off|A threshold was measured with deactivated feature.
10781475|NCT04723173|OG000|Outcome|Feedback Management Off|The participants shall evaluate if there are artefacts audible without additional gain, while hearing a recorded conversation
10781476|NCT04723173|OG001|Outcome|Feedback Management on|The participants shall evaluate if there are artefacts audible with with additional gain, while hearing a recorded conversation
10781477|NCT04723173|EG000|Reported Event|Events During the Test Period|During the test period no Adverse Events, serious adverse events or other events occured.
10781478|NCT04723173|EG001|Reported Event|Events Prior to Test Period (After Screening Appointment and Signed Informed Consent Form)|"The adverse events of this study were not related to the investigational device or to a test of the study.~Therefore we report the adverse events in one group instead of each individual condition.~The occurred events were prior to a test / study appointment. The adverse events occurred after the screening appointment, but before any intervention. Therefore the adverse events cannot be attributed to any single study condition. As such we report adverse events here simply for the entire study cohort."
10781479|NCT04552470|BG000|Baseline|Placebo|Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
10781480|NCT04552470|BG001|Baseline|PF-06882961 40 mg|Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
10781481|NCT04552470|BG002|Baseline|PF-06882961 80 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
10781482|NCT04552470|BG003|Baseline|PF-06882961 120 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
10781483|NCT04552470|BG004|Baseline|Total|Total of all reporting groups
10781484|NCT04552470|FG000|Participant Flow|Placebo|Participants with type 2 diabetes mellitus (T2DM) were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
10781485|NCT04552470|FG001|Participant Flow|PF-06882961 40 mg|Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
10781486|NCT04552470|FG002|Participant Flow|PF-06882961 80 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
10781487|NCT04552470|FG003|Participant Flow|PF-06882961 120 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
10781488|NCT04552470|OG000|Outcome|Placebo|Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
11380419|NCT01403948|FG002|Participant Flow|BI 836826 9 mg iv (Caucasian Patients)|"BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380420|NCT01403948|FG003|Participant Flow|BI 836826 25 mg iv (Caucasian Patients)|"BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380421|NCT01403948|FG004|Participant Flow|BI 836826 50 mg iv (Caucasian Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380422|NCT01403948|FG005|Participant Flow|BI 836826 50mg iv (Korean Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380423|NCT01403948|FG006|Participant Flow|BI 836826 100 mg iv (Caucasian Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380424|NCT01403948|FG007|Participant Flow|BI 836826 100 mg iv (Korean Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380425|NCT01403948|FG008|Participant Flow|BI 836826 150 mg iv (Caucasian Patients)|"BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380426|NCT01403948|FG009|Participant Flow|BI 836826 200 mg iv (Caucasian Patients)|"BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380427|NCT01403948|OG000|Outcome|BI 836826|Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
11380428|NCT01403948|OG000|Outcome|BI 836826 1 mg iv (Caucasian Patients)|"BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380429|NCT01403948|OG001|Outcome|BI 836826 3 mg iv (Caucasian Patients)|"BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380430|NCT01403948|OG002|Outcome|BI 836826 9 mg iv (Caucasian Patients)|"BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380431|NCT01403948|OG003|Outcome|BI 836826 25 mg iv (Caucasian Patients)|"BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
10781489|NCT04552470|OG001|Outcome|PF-06882961 40 mg|Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
10781490|NCT04552470|OG002|Outcome|PF-06882961 80 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
10781491|NCT04552470|OG003|Outcome|PF-06882961 120 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
10781492|NCT04552470|OG000|Outcome|PF-06882961 40 mg|Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
10781493|NCT04552470|OG001|Outcome|PF-06882961 80 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
10781494|NCT04552470|OG002|Outcome|PF-06882961 120 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
10781495|NCT04552470|EG000|Reported Event|Placebo|Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.
10781496|NCT04552470|EG001|Reported Event|PF-06882961 40 mg|Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
10781497|NCT04552470|EG002|Reported Event|PF-06882961 80 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.
10781498|NCT04552470|EG003|Reported Event|PF-06882961 120 mg|Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
10801556|NCT03529773|BG039|Baseline|Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801557|NCT03529773|BG040|Baseline|Total|Total of all reporting groups
10801558|NCT03529773|FG000|Participant Flow|Sentinel Cohort: Respiratory Syncytial Virus (RSV) Vaccine 60 Microgram (mcg) Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801559|NCT03529773|FG001|Participant Flow|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801560|NCT03529773|FG002|Participant Flow|Sentinel Cohort: RSV 120 mcg Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801561|NCT03529773|FG003|Participant Flow|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801562|NCT03529773|FG004|Participant Flow|Sentinel Cohort: RSV 240 mcg Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801563|NCT03529773|FG005|Participant Flow|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801564|NCT03529773|FG006|Participant Flow|Sentinel Cohort: Placebo Age 18-49 Years|Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10801565|NCT03529773|FG007|Participant Flow|Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801566|NCT03529773|FG008|Participant Flow|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801567|NCT03529773|FG009|Participant Flow|Sentinel Cohort: RSV 120 mcg Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
11193777|NCT02147613|OG000|Outcome|High Intensity Interval Training|"High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)~High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)"
11380432|NCT01403948|OG004|Outcome|BI 836826 50 mg iv (Caucasian Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380433|NCT01403948|OG005|Outcome|BI 836826 100 mg iv (Caucasian Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380434|NCT01403948|OG006|Outcome|BI 836826 150 mg iv (Caucasian Patients)|"BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380435|NCT01403948|OG007|Outcome|BI 836826 200 mg iv (Caucasian Patients)|"BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380436|NCT01403948|OG005|Outcome|BI 836826 50mg iv (Korean Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380437|NCT01403948|OG006|Outcome|BI 836826 100 mg iv (Caucasian Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380438|NCT01403948|OG007|Outcome|BI 836826 100 mg iv (Korean Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380439|NCT01403948|OG008|Outcome|BI 836826 150 mg iv (Caucasian Patients)|"BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380440|NCT01403948|OG009|Outcome|BI 836826 200 mg iv (Caucasian Patients)|"BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380441|NCT01403948|EG000|Reported Event|BI 836826 1 mg iv (Caucasian Patients)|"BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380442|NCT01403948|EG001|Reported Event|BI 836826 3 mg iv (Caucasian Patients)|"BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380443|NCT01403948|EG002|Reported Event|BI 836826 9 mg iv (Caucasian Patients)|"BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11193778|NCT02147613|OG001|Outcome|Moderate Intensity Exercise Training|"3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)~Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)"
11193779|NCT02147613|EG000|Reported Event|High Intensity Interval Training|"High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)~High intensity interval training: 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)"
11193780|NCT02147613|EG001|Reported Event|Moderate Intensity Exercise Training|"3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)~Moderate intensity exercise training: 3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)"
11193781|NCT02147626|BG000|Baseline|Information and Screening Group|"Intervention: The patient website will include the AHA Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) DASH website, and the NIH smoking cessation website~Information and Screening Group"
11193782|NCT02147626|BG001|Baseline|HH4M Intervention Arm|"Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the AHA Class I Lifestyle recommendations for women with a history of preeclampsia.~Web-based educational and motivational modules~Information and Screening Group"
11193783|NCT02147626|BG002|Baseline|Total|Total of all reporting groups
11193784|NCT02147626|FG000|Participant Flow|Information and Screening Group|"Intervention: The patient website will include the American Heart Association (AHA) Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) Dietary Approaches to Stop Hypertension (DASH) website, and the NIH smoking cessation website~Information and Screening Group"
11380444|NCT01403948|EG003|Reported Event|BI 836826 25 mg iv (Caucasian Patients)|"BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380445|NCT01403948|EG004|Reported Event|BI 836826 50 mg iv (Caucasian Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380446|NCT01403948|EG005|Reported Event|BI 836826 50mg iv (Korean Patients)|"BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11193785|NCT02147626|FG001|Participant Flow|HH4M Intervention Arm|"Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the American Heart Association ( AHA) Class I Lifestyle recommendations for women with a history of preeclampsia.~Web-based educational and motivational modules~Information and Screening Group"
11193786|NCT02147626|OG000|Outcome|Information and Screening Group|"Intervention: The patient website will include the AHA Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) DASH website, and the NIH smoking cessation website~Information and Screening Group"
11193787|NCT02147626|OG001|Outcome|HH4M Intervention Arm|"Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the AHA Class I Lifestyle recommendations for women with a history of preeclampsia.~Web-based educational and motivational modules~Information and Screening Group"
11193788|NCT02147626|EG000|Reported Event|Information and Screening Group|"Intervention: The patient website will include the AHA Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) DASH website, and the NIH smoking cessation website~Information and Screening Group"
11193789|NCT02147626|EG001|Reported Event|HH4M Intervention Arm|"Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the AHA Class I Lifestyle recommendations for women with a history of preeclampsia.~Web-based educational and motivational modules~Information and Screening Group"
11193790|NCT02147691|BG000|Baseline|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
11193791|NCT02147691|BG001|Baseline|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
11193792|NCT02147691|BG002|Baseline|Total|Total of all reporting groups
11380447|NCT01403948|EG006|Reported Event|BI 836826 100 mg iv (Caucasian Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11193793|NCT02147691|FG000|Participant Flow|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
10781499|NCT04251884|BG000|Baseline|Receiving the Pudendal Nerve Block|Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
10781500|NCT04251884|BG001|Baseline|Not Receiving the Pudendal Nerve Block|No ultrasound-guided pudendal nerve block performed.
10781501|NCT04251884|BG002|Baseline|Total|Total of all reporting groups
10781502|NCT04251884|FG000|Participant Flow|Receiving the Pudendal Nerve Block|Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
10781503|NCT04251884|FG001|Participant Flow|Not Receiving the Pudendal Nerve Block|No ultrasound-guided pudendal block performed
10781504|NCT04251884|OG000|Outcome|Receiving the Pudendal Nerve Block|Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
10781505|NCT04251884|OG001|Outcome|Not Receiving the Pudendal Nerve Block|No ultrasound-guided pudendal nerve block performed.
10781506|NCT04251884|OG000|Outcome|Receiving the Pudendal Nerve Block|Ultrasound-guided pudendal nerve block with performed 20 mls Ropivacaine 0.75%.
10781507|NCT04251884|EG000|Reported Event|Receiving the Pudendal Nerve Block|Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
10781508|NCT04251884|EG001|Reported Event|Not Receiving the Pudendal Nerve Block|No ultrasound-guided pudendal nerve block performed
10781509|NCT03683823|BG000|Baseline|Attention Guidance|"In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.~Attention guidance: Explicitly guiding attention towards faces during public speaking exposures"
10781510|NCT03683823|BG001|Baseline|Control Intervention|"Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.~On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.~Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.~Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.~Between speeches participants will have a 1-minute break.~Control intervention: Public speaking exposures"
10781511|NCT03683823|BG002|Baseline|Total|Total of all reporting groups
10781512|NCT03683823|FG000|Participant Flow|Attention Guidance|"In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.~Attention guidance: Explicitly guiding attention towards faces during public speaking exposures"
10781513|NCT03683823|FG001|Participant Flow|Control Intervention|"Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.~On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.~Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.~Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.~Between speeches participants will have a 1-minute break.~Control intervention: Public speaking exposures"
10781514|NCT03683823|OG000|Outcome|Attention Guidance|"In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.~Attention guidance: Explicitly guiding attention towards faces during public speaking exposures"
10801568|NCT03529773|FG010|Participant Flow|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
11193794|NCT02147691|FG001|Participant Flow|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
11193795|NCT02147691|OG000|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
11193796|NCT02147691|OG001|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
11193797|NCT02147691|EG000|Reported Event|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
11193798|NCT02147691|EG001|Reported Event|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
11193799|NCT02147769|BG000|Baseline|Preterm Infants Monitored With NIRS|"All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.~NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure."
11193800|NCT02147769|FG000|Participant Flow|Preterm Infants Monitored With NIRS|"All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.~NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure."
11193801|NCT02147769|OG000|Outcome|Preterm Infants Monitored With NIRS|"All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.~NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure."
11193802|NCT02147769|EG000|Reported Event|Preterm Infants Monitored With NIRS|"All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.~NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure."
11193803|NCT02147899|BG000|Baseline|SYM-1219 Low Dose|"Administered orally~SYM-1219"
11193804|NCT02147899|BG001|Baseline|SYM-1219 High Dose|"Administered orally~SYM-1219"
11193805|NCT02147899|BG002|Baseline|Placebo|"Administered orally~Placebo"
11193806|NCT02147899|BG003|Baseline|Total|Total of all reporting groups
11193807|NCT02147899|FG000|Participant Flow|SYM-1219 Low Dose|"Administered orally~SYM-1219"
11193808|NCT02147899|FG001|Participant Flow|SYM-1219 High Dose|"Administered orally~SYM-1219"
11193809|NCT02147899|FG002|Participant Flow|Placebo|"Administered orally~Placebo"
11193810|NCT02147899|OG000|Outcome|SYM-1219 Low Dose|"Administered orally~SYM-1219"
11193811|NCT02147899|OG001|Outcome|SYM-1219 High Dose|"Administered orally~SYM-1219"
11193812|NCT02147899|OG002|Outcome|Placebo|"Administered orally~Placebo"
11193813|NCT02147899|EG000|Reported Event|SYM-1219 Low Dose|"Administered orally~SYM-1219"
11193814|NCT02147899|EG001|Reported Event|SYM-1219 High Dose|"Administered orally~SYM-1219"
11193815|NCT02147899|EG002|Reported Event|Placebo|"Administered orally~Placebo"
11193816|NCT02147990|BG000|Baseline|Rociletinib 625 mg BID T790M+|Rociletinib 625 mg BID in patients with T790M-positive tumor status
11193817|NCT02147990|BG001|Baseline|Rociletinib 500 mg BID T790M+|Rociletinib 500 mg BID in patients with T790M-positive tumor status
11193818|NCT02147990|BG002|Baseline|Rociletinib 500 mg BID T790M-|Rociletinib 500 mg BID in patients with T790M-negative tumor status
11193819|NCT02147990|BG003|Baseline|Total|Total of all reporting groups
11193820|NCT02147990|FG000|Participant Flow|Rociletinib 625 mg BID T790M+|Rociletinib 625 mg BID in patients with T790M-positive tumor status
11193821|NCT02147990|FG001|Participant Flow|Rociletinib 500 mg BID T790M+|Rociletinib 500 mg BID in patients with T790M-positive tumor status
11193822|NCT02147990|FG002|Participant Flow|Rociletinib 500 mg BID T790M-|Rociletinib 500 mg BID in patients with T790M-negative tumor status
11193823|NCT02147990|OG000|Outcome|Rociletinib 625 mg BID T790M+|Rociletinib 625 mg BID in patients with T790M-positive tumor status
11193824|NCT02147990|OG001|Outcome|Rociletinib 500 mg BID T790M+|Rociletinib 500 mg BID in patients with T790M-positive tumor status
11193825|NCT02147990|OG002|Outcome|Rociletinib 500 mg BID T790M-|Rociletinib 500 mg BID in patients with T790M-negative tumor status
11193826|NCT02147990|OG002|Outcome|All T790M+|All Rociletinib 500 mg BID and 625 mg BID patients with T790M-positive tumor status
11193827|NCT02147990|EG000|Reported Event|Rociletinib 625 mg BID T790M+|Rociletinib 625 mg BID in patients with T790M-positive tumor status
11193828|NCT02147990|EG001|Reported Event|Rociletinib 500 mg BID T790M+|Rociletinib 500 mg BID in patients with T790M-positive tumor status
11193829|NCT02147990|EG002|Reported Event|Rociletinib 500 mg BID T790M-|Rociletinib 500 mg BID in patients with T790M-negative tumor status
11193830|NCT02148107|BG000|Baseline|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
11193831|NCT02148107|BG001|Baseline|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
11193832|NCT02148107|BG002|Baseline|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
11193833|NCT02148107|BG003|Baseline|Total|Total of all reporting groups
11193834|NCT02148107|FG000|Participant Flow|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
11193835|NCT02148107|FG001|Participant Flow|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
11193836|NCT02148107|FG002|Participant Flow|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
11193837|NCT02148107|OG000|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
11193838|NCT02148107|OG001|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
11193839|NCT02148107|OG002|Outcome|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
11193840|NCT02148107|EG000|Reported Event|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
11193841|NCT02148107|EG001|Reported Event|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
11193842|NCT02148107|EG002|Reported Event|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
10781515|NCT03683823|OG001|Outcome|Control Intervention|"Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.~On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.~Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.~Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.~Between speeches participants will have a 1-minute break.~Control intervention: Public speaking exposures"
10781516|NCT03683823|EG000|Reported Event|Attention Guidance|"In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.~Attention guidance: Explicitly guiding attention towards faces during public speaking exposures"
10781517|NCT03683823|EG001|Reported Event|Control Intervention|"Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.~On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.~Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.~Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.~Between speeches participants will have a 1-minute break.~Control intervention: Public speaking exposures"
10781518|NCT03546439|BG000|Baseline|Figure of 8|Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures
10781519|NCT03546439|BG001|Baseline|Manual Compression|Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures
10781520|NCT03546439|BG002|Baseline|Perclose Device|Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
10781521|NCT03546439|BG003|Baseline|Total|Total of all reporting groups
10781522|NCT03546439|FG000|Participant Flow|Figure of 8|Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures
10781523|NCT03546439|FG001|Participant Flow|Manual Compression|Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures
10781524|NCT03546439|FG002|Participant Flow|Perclose Device|Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
10781525|NCT03546439|OG000|Outcome|Figure of 8|Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures
11193843|NCT02148211|BG000|Baseline|Exposure Group|Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
11193844|NCT02148211|FG000|Participant Flow|Exposed Group|Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
11193845|NCT02148211|OG000|Outcome|Exposure Group|Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
10781526|NCT03546439|OG001|Outcome|Manual Compression|Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures
11193846|NCT02148211|EG000|Reported Event|Exposure Group|Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
11193847|NCT02148250|BG000|Baseline|All Subjects|"100 or 200 syringe units of U-500 regular insulin~U-500 insulin: Subjects are randomized to receive 100 or 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks."
11193848|NCT02148250|FG000|Participant Flow|100 Syringe Units, Then 200|Participants in this arm were randomized to receive the 100 syringe units of U-500 insulin intervention first, then 200 units.
11193849|NCT02148250|FG001|Participant Flow|200 Syringe Units, Then 100|Participants in this arm were randomized to receive the 200 syringe units of U-500 insulin intervention first, then 100 units.
11193850|NCT02148250|OG000|Outcome|100 Syringe Units|Arm: 100 syringe units of U-500 regular insulin
11193851|NCT02148250|OG001|Outcome|200 Syringe Units|Arm: 200 syringe units of U-500 regular insulin
11193852|NCT02148250|OG001|Outcome|200 Syringe Units|Arm: 100 syringe units of U-500 regular insulin
11193853|NCT02148250|EG000|Reported Event|100 Syringe Units|Arm: 100 syringe units of U-500 regular insulin
11193854|NCT02148250|EG001|Reported Event|200 Syringe Units|Arm: 200 syringe units of U-500 regular insulin
11193855|NCT02148302|BG000|Baseline|Harvesting Device (CelluTome©)|"open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.~Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.~A run-in period of two weeks followed by twelve weeks of active treatment~Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone."
11193856|NCT02148302|BG001|Baseline|Control: SOC Alone|The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
10781527|NCT03546439|OG002|Outcome|Perclose Device|Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
10781528|NCT03546439|EG000|Reported Event|Figure of 8|Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures
10781529|NCT03546439|EG001|Reported Event|Manual Compression|Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures
10781530|NCT03546439|EG002|Reported Event|Perclose Device|Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
10781531|NCT03515551|BG000|Baseline|Phase 1: IMCnyeso 3 mcg|Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781532|NCT03515551|BG001|Baseline|Phase 1: IMCnyeso 10 mcg|Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781533|NCT03515551|BG002|Baseline|Phase 1: IMCnyeso 30 mcg|Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781534|NCT03515551|BG003|Baseline|Phase 1: IMCnyeso 100 mcg|Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781535|NCT03515551|BG004|Baseline|Phase 1: IMCnyeso 30-100 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
10781536|NCT03515551|BG005|Baseline|Phase 1: IMCnyeso 30-100-180 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
10781537|NCT03515551|BG006|Baseline|Phase 1: IMCnyeso 30-100-300 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
10781538|NCT03515551|BG007|Baseline|Total|Total of all reporting groups
10781539|NCT03515551|FG000|Participant Flow|Phase 1: IMCnyeso 3 mcg|Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781540|NCT03515551|FG001|Participant Flow|Phase 1: IMCnyeso 10 mcg|Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781541|NCT03515551|FG002|Participant Flow|Phase 1: IMCnyeso 30 mcg|Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781542|NCT03515551|FG003|Participant Flow|Phase 1: IMCnyeso 100 mcg|Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781543|NCT03515551|FG004|Participant Flow|Phase 1: IMCnyeso 30-100 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
10781544|NCT03515551|FG005|Participant Flow|Phase 1: IMCnyeso 30-100-180 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
10781545|NCT03515551|FG006|Participant Flow|Phase 1: IMCnyeso 30-100-300 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
10781546|NCT03515551|OG000|Outcome|Phase 1: IMCnyeso 3 mcg|Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781547|NCT03515551|OG001|Outcome|Phase 1: IMCnyeso 10 mcg|Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781548|NCT03515551|OG002|Outcome|Phase 1: IMCnyeso 30 mcg|Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781549|NCT03515551|OG003|Outcome|Phase 1: IMCnyeso 100 mcg|Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781550|NCT03515551|OG004|Outcome|Phase 1: IMCnyeso 30-100 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
10781551|NCT03515551|OG005|Outcome|Phase 1: IMCnyeso 30-100-180 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
10781552|NCT03515551|OG006|Outcome|Phase 1: IMCnyeso 30-100-300 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
10781553|NCT03515551|OG000|Outcome|Phase 2: Dose Expansion|Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
10781554|NCT03515551|OG006|Outcome|IMCnyeso 30-100-300 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
10781555|NCT03515551|OG007|Outcome|Phase 2: Dose Expansion|Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
10781556|NCT03515551|OG000|Outcome|Phase 1: Dose Escalation|Four fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso.
10781557|NCT03515551|OG001|Outcome|Phase 2: Dose Expansion|Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
10781558|NCT03515551|EG000|Reported Event|Phase 1: IMCnyeso 3 mcg|Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781559|NCT03515551|EG001|Reported Event|Phase 1: IMCnyeso 10 mcg|Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781560|NCT03515551|EG002|Reported Event|Phase 1: IMCnyeso 30 mcg|Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781561|NCT03515551|EG003|Reported Event|Phase 1: IMCnyeso 100 mcg|Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
10781562|NCT03515551|EG004|Reported Event|Phase 1: IMCnyeso 30-100 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
10781563|NCT03515551|EG005|Reported Event|Phase 1: IMCnyeso 30-100-180 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
10781564|NCT03515551|EG006|Reported Event|Phase 1: IMCnyeso 30-100-300 mcg|IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
10781565|NCT03385265|BG000|Baseline|DIPPer Academy- Parents|"Parents randomized to this group will participate in the DIPPer Academy curriculum.~DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet."
10781566|NCT03385265|BG001|Baseline|Standard of Care Control- Parents|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
10781567|NCT03385265|BG002|Baseline|DIPPer Academy- Children|"Parents randomized to this group will participate in the DIPPer Academy curriculum. We collect children's HbA1c level.~DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet. Children do not receive treatment."
10781568|NCT03385265|BG003|Baseline|Standard of Care Control- Children|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect children's HbA1c level.
10781569|NCT03385265|BG004|Baseline|Total|Total of all reporting groups
10781570|NCT03385265|FG000|Participant Flow|DIPPer Academy- Parents|Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet.
10781571|NCT03385265|FG001|Participant Flow|Standard of Care Control- Parents|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
10781572|NCT03385265|FG002|Participant Flow|DIPPer Academy- Children|Parents randomized to this group will participate in DIPPer Academy via the internet. We collect Child HbA1c levels. Children do not receive treatment.
10781573|NCT03385265|FG003|Participant Flow|Standard of Care- Children|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect Child HbA1c levels.
10781574|NCT03385265|OG000|Outcome|DIPPer Academy|"Parents randomized to this group will participate in the DIPPer Academy curriculum.~DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet."
10781575|NCT03385265|OG001|Outcome|Standard of Care Control|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
10781576|NCT03385265|OG000|Outcome|DIPPer Academy|"Families randomized to this group will participate in the DIPPer Academy curriculum.~DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet."
10781577|NCT03385265|OG001|Outcome|Standard of Care Control|"DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.~Standard of Care: Families in the standard of care control group will be instructed to manage their child's T1D as recommended."
10781578|NCT03385265|OG000|Outcome|DIPPer|Parents participating in DIPPer Academy
10781579|NCT03385265|OG001|Outcome|Control|Parents receiving standard care
10781580|NCT03385265|EG000|Reported Event|DIPPer Academy- Parents|Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet.
10781581|NCT03385265|EG001|Reported Event|Standard of Care Control- Parents|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
10781582|NCT03385265|EG002|Reported Event|DIPPer Academy- Children|Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet. Children did not receive treatment. We collected child HbA1c.
10781583|NCT03385265|EG003|Reported Event|Standard of Care Control- Children|Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collected child HbA1c
10781584|NCT03316807|BG000|Baseline|60 µg Dose Hepatitis B Vaccine|"60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose"
10781585|NCT03316807|BG001|Baseline|20 µg Dose Hepatitis B Vaccine|"20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose"
10781586|NCT03316807|BG002|Baseline|Total|Total of all reporting groups
10781587|NCT03316807|FG000|Participant Flow|60 µg Dose Hepatitis B Vaccine|"60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose"
11193857|NCT02148302|BG002|Baseline|Total|Total of all reporting groups
10781588|NCT03316807|FG001|Participant Flow|20 µg Dose Hepatitis B Vaccine|"20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose"
10781589|NCT03316807|OG000|Outcome|60 µg Dose Hepatitis B Vaccine|"60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose"
10781590|NCT03316807|OG001|Outcome|20 µg Dose Hepatitis B Vaccine|"20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose"
10781591|NCT03316807|EG000|Reported Event|60 µg Dose Hepatitis B Vaccine|"60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose"
10781592|NCT03316807|EG001|Reported Event|20 µg Dose Hepatitis B Vaccine|"20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6~20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose"
10781593|NCT03138538|BG000|Baseline|M8891 7 mg|Participant received M8891 at dose of 7 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781594|NCT03138538|BG001|Baseline|M8891 12 mg|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781595|NCT03138538|BG002|Baseline|M8891 20 mg|Participant received M8891 at dose of 20 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781596|NCT03138538|BG003|Baseline|M8891 35 mg|Participant received M8891 at dose of 35 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781597|NCT03138538|BG004|Baseline|M8891 60 mg|Participant received M8891 at dose of 60 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781598|NCT03138538|BG005|Baseline|M8891 80 mg|Participant received M8891 at dose of 80 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781599|NCT03138538|BG006|Baseline|Total|Total of all reporting groups
10781600|NCT03138538|FG000|Participant Flow|M8891 7 mg|Participant received M8891 at dose of 7 milligrams (mg) orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781601|NCT03138538|FG001|Participant Flow|M8891 12 mg|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781602|NCT03138538|FG002|Participant Flow|M8891 20 mg|Participant received M8891 at dose of 20 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781603|NCT03138538|FG003|Participant Flow|M8891 35 mg|Participant received M8891 at dose of 35 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781604|NCT03138538|FG004|Participant Flow|M8891 60 mg|Participant received M8891 at dose of 60 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781605|NCT03138538|FG005|Participant Flow|M8891 80 mg|Participant received M8891 at dose of 80 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781606|NCT03138538|OG000|Outcome|M8891 7 mg|Participant received M8891 at dose of 7 milligrams (mg) orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781607|NCT03138538|OG001|Outcome|M8891 12 mg|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781608|NCT03138538|OG002|Outcome|M8891 20 mg|Participant received M8891 at dose of 20 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781609|NCT03138538|OG003|Outcome|M8891 35 mg|Participant received M8891 at dose of 35 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10801569|NCT03529773|FG011|Participant Flow|Sentinel Cohort: RSV 240 mcg Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10781610|NCT03138538|OG004|Outcome|M8891 60 mg|Participant received M8891 at dose of 60 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781611|NCT03138538|OG005|Outcome|M8891 80 mg|Participant received M8891 at dose of 80 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781612|NCT03138538|OG000|Outcome|M8891 7 mg|Participant received M8891 at dose of 7 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781613|NCT03138538|OG005|Outcome|M8891 80 mg|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781614|NCT03138538|OG000|Outcome|Less Than or Equal to (<=) 20 mg M8891|All participants who received oral capsule of M8891 at dose <= 20 mg first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781615|NCT03138538|OG001|Outcome|Greater Than (>) 20 mg M8891|All participants who received oral capsule of M8891 at dose of > 20mg first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781616|NCT03138538|OG001|Outcome|M8891 12 mg qd|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781617|NCT03138538|EG000|Reported Event|M8891 7 mg|Participant received M8891 at dose of 7 milligrams (mg) orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781618|NCT03138538|EG001|Reported Event|M8891 12 mg|Participant received M8891 at dose of 12 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781619|NCT03138538|EG002|Reported Event|M8891 20 mg|Participant received M8891 at dose of 20 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781620|NCT03138538|EG003|Reported Event|M8891 35 mg|Participant received M8891 at dose of 35 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781621|NCT03138538|EG004|Reported Event|M8891 60 mg|Participant received M8891 at dose of 60 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10781622|NCT03138538|EG005|Reported Event|M8891 80 mg|Participant received M8891 at dose of 80 mg orally with first dose in Cycle 1 Day 1 and consist of consecutive 21-day cycles of continuous once daily M8891 monotherapy under fasting conditions until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
10801570|NCT03529773|FG012|Participant Flow|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801571|NCT03529773|FG013|Participant Flow|Sentinel Cohort: Placebo Age 50-85 Years|Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10801572|NCT03529773|FG014|Participant Flow|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 milliliter (mL) seasonal inactivated influenza vaccine (SIIV) intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801573|NCT03529773|FG015|Participant Flow|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801574|NCT03529773|FG016|Participant Flow|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11339840|NCT03639766|FG000|Participant Flow|All Study Participants|"All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand.~The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline.~The saline injection consisted of 10 ml of non-bacteriostatic normal saline."
10801575|NCT03529773|FG017|Participant Flow|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11339841|NCT03639766|OG000|Outcome|Abobotulinum Toxin A|"Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.~AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution"
10781636|NCT02919306|BG000|Baseline|Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine|Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781637|NCT02919306|BG001|Baseline|Placebo|Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781638|NCT02919306|BG002|Baseline|Total|Total of all reporting groups
10781639|NCT02919306|FG000|Participant Flow|Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine|Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781640|NCT02919306|FG001|Participant Flow|Placebo|Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10801576|NCT03529773|FG018|Participant Flow|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801577|NCT03529773|FG019|Participant Flow|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801578|NCT03529773|FG020|Participant Flow|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801579|NCT03529773|FG021|Participant Flow|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801580|NCT03529773|FG022|Participant Flow|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10850906|NCT03999554|FG003|Participant Flow|Low Dose Bris10 M2SR|"Low dose Bris10 M2SR will be administered intranasally on days 1 and 29~LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10781641|NCT02919306|OG000|Outcome|Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine|Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781642|NCT02919306|OG001|Outcome|Placebo|Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781643|NCT02919306|EG000|Reported Event|Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine|Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781644|NCT02919306|EG001|Reported Event|Placebo|Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
10781645|NCT02763189|BG000|Baseline|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
10781646|NCT02763189|BG001|Baseline|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
10781647|NCT02763189|BG002|Baseline|Total|Total of all reporting groups
10781648|NCT02763189|FG000|Participant Flow|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
10781649|NCT02763189|FG001|Participant Flow|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
10781650|NCT02763189|OG000|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
10781651|NCT02763189|OG001|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
10781652|NCT02763189|EG000|Reported Event|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
11339842|NCT03639766|OG001|Outcome|Saline Solution|"Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.~Saline solution: Non-bacteriostatic saline solution"
10781653|NCT02763189|EG001|Reported Event|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
10781654|NCT02700945|BG000|Baseline|Reveal LINQ™ Insertable Cardiac Monitor|"Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.~Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation."
10781655|NCT02700945|BG001|Baseline|Control Arm|Subjects randomized to the control arm will be followed per site specific standard of care.
10781656|NCT02700945|BG002|Baseline|Total|Total of all reporting groups
10781657|NCT02700945|FG000|Participant Flow|Reveal LINQ™ Insertable Cardiac Monitor|"Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.~Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation."
10781658|NCT02700945|FG001|Participant Flow|Control Arm|Subjects randomized to the control arm will be followed per site specific standard of care.
10781659|NCT02700945|OG000|Outcome|Reveal LINQ™ Insertable Cardiac Monitor|"Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.~Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation."
10781660|NCT02700945|OG001|Outcome|Control Arm|Subjects randomized to the control arm will be followed per site specific standard of care.
10781661|NCT02700945|EG000|Reported Event|Reveal LINQ™ Insertable Cardiac Monitor|"Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.~Reveal LINQ™ Insertable Cardiac Monitor: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation."
10781662|NCT02700945|EG001|Reported Event|Control Arm|Subjects randomized to the control arm will be followed per site specific standard of care.
10781663|NCT02659514|BG000|Baseline|Cohort 1: Poziotinib 24 mg|Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781664|NCT02659514|BG001|Baseline|Cohort 2: Poziotinib 16 mg|Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781665|NCT02659514|BG002|Baseline|Total|Total of all reporting groups
10781666|NCT02659514|FG000|Participant Flow|Cohort 1: Poziotinib 24 mg|Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.
10781667|NCT02659514|FG001|Participant Flow|Cohort 2: Poziotinib 16 mg|Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781668|NCT02659514|OG000|Outcome|Cohort 1: Poziotinib 24 mg|Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781669|NCT02659514|OG001|Outcome|Cohort 2: Poziotinib 16 mg|Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781670|NCT02659514|EG000|Reported Event|Cohort 1: Poziotinib 24 mg|Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781671|NCT02659514|EG001|Reported Event|Cohort 2: Poziotinib 16 mg|Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
10781672|NCT02435173|BG000|Baseline|Part I: CDZ173|Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
10781673|NCT02435173|BG001|Baseline|Part II: CDZ173 70 mg|Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
10781674|NCT02435173|BG002|Baseline|Part II: Placebo|Participants received Placebo b.i.d. from Day 1 to Day 85.
10781675|NCT02435173|BG003|Baseline|Total|Total of all reporting groups
10781676|NCT02435173|FG000|Participant Flow|Part I: CDZ173|Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
10781677|NCT02435173|FG001|Participant Flow|Part II: CDZ173 70 mg|Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
10781678|NCT02435173|FG002|Participant Flow|Part II: Placebo|Participants received Placebo b.i.d. from Day 1 to Day 85.
10781679|NCT02435173|OG000|Outcome|Part I: CDZ173 10 mg|Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
10781680|NCT02435173|OG000|Outcome|Part I: CDZ173|Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
10781681|NCT02435173|OG000|Outcome|Part II: CDZ173|Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
10781682|NCT02435173|OG001|Outcome|Part II: Placebo|Participants received Placebo b.i.d. from Day 1 to Day 85.
10781683|NCT02435173|OG001|Outcome|Part II: CDZ173|Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
10781684|NCT02435173|OG002|Outcome|Part II: Placebo|Participants received Placebo b.i.d. from Day 1 to Day 85.
11339843|NCT03639766|EG000|Reported Event|Abobotulinum Toxin A|"Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.~AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution"
10781685|NCT02435173|EG000|Reported Event|Part I: CDZ173 10 mg|Participants received CDZ173 10 mg b.i.d. from Day 1 to Day 28.
11339844|NCT03639766|EG001|Reported Event|Saline Solution|"Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.~Saline solution: Non-bacteriostatic saline solution"
11339845|NCT03639779|BG000|Baseline|All Participants|All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion.
11339846|NCT03639779|FG000|Participant Flow|All Paticipants|"All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion~50 ml vials of sodium thiosulfate (250mg/ml) were used for treatment. 30 ml vials of sodium chloride 0.9% will be used for the control treatment. A volume of 0.1 ml/cm2 of STS or normal will be injected into each lesion."
11339847|NCT03639779|OG000|Outcome|Sodium Thiosulfate|"50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.~Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion."
11339848|NCT03639779|OG001|Outcome|Saline Solution|"30 ml vials of sodium chloride 0.9% will be used for the control treatment.~Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion."
11339849|NCT03639779|EG000|Reported Event|Sodium Thiosulfate|"50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.~Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion."
11339850|NCT03639779|EG001|Reported Event|Saline Solution|"30 ml vials of sodium chloride 0.9% will be used for the control treatment.~Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion."
11339851|NCT03639857|BG000|Baseline|All Study Participants|"All study participants received treatment of 2 or 3 lesions of cutaneous lupus depending upon their skin type.~Participants with skin type 1, 2 or 3 received treatment of 3 lesions:~One lesion treated with 532nm laser~One lesion treated with the 1064nm laser~One lesion treated with topical corticosteroid~Participants with skin type 4, 5 or 6 received treatment of 2 lesions~One lesion treated with the 1064nm laser~One lesion treated with topical corticosteroid"
11339852|NCT03639857|FG000|Participant Flow|532nm Laser and Topical Corticosteroid|"532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~532nm laser: 532nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339853|NCT03639857|FG001|Participant Flow|1064nm Laser and Topical Corticosteroid|"1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339854|NCT03639857|FG002|Participant Flow|Topical Corticosteroid Alone|"Topical corticosteroid is applied to the patient's lesion.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339855|NCT03639857|OG000|Outcome|532nm Laser and Topical Corticosteroid|"532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~532nm laser: 532nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339856|NCT03639857|OG001|Outcome|1064nm Laser and Topical Corticosteroid|"1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339857|NCT03639857|OG002|Outcome|Topical Corticosteroid Alone|"Topical corticosteroid is applied to the patient's lesion.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339858|NCT03639857|EG000|Reported Event|532nm Laser and Topical Corticosteroid|"532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~532nm laser: 532nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339859|NCT03639857|EG001|Reported Event|1064nm Laser and Topical Corticosteroid|"1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid.~1064nm laser: 1064nm laser will be used to treat the lesion in this study arm.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339860|NCT03639857|EG002|Reported Event|Topical Corticosteroid Alone|"Topical corticosteroid is applied to the patient's lesion.~Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm."
11339861|NCT03639987|BG000|Baseline|Group 1|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
11339862|NCT03639987|BG001|Baseline|Group 2|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
11339863|NCT03639987|BG002|Baseline|Total|Total of all reporting groups
11339864|NCT03639987|FG000|Participant Flow|Group 1|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
11339865|NCT03639987|FG001|Participant Flow|Group 2|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
11339866|NCT03639987|OG000|Outcome|Group 1|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
11339867|NCT03639987|OG001|Outcome|Group 2|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
11339868|NCT03639987|EG000|Reported Event|Group 1|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
11339869|NCT03639987|EG001|Reported Event|Group 2|Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
11339870|NCT03640052|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11339871|NCT03640052|FG000|Participant Flow|Placebo First|Placebo administered before sleep for 1 night, followed by LTM1201L, LTM1201LD, LTM1201LN and LTM1201LB, administered 1 week apart in the hospital
10781686|NCT02435173|EG001|Reported Event|Part I: CDZ173 30 mg|Participants received CDZ173 30 mg b.i.d. from Day 29 to Day 56.
10781687|NCT02435173|EG002|Reported Event|Part I: CDZ173 70 mg|Participants received CDZ173 70 mg b.i.d. from Day 57 to Day 84.
11380448|NCT01403948|EG007|Reported Event|BI 836826 100 mg iv (Korean Patients)|"BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380449|NCT01403948|EG008|Reported Event|BI 836826 150 mg iv (Caucasian Patients)|"BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380450|NCT01403948|EG009|Reported Event|BI 836826 200 mg iv (Caucasian Patients)|"BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.~Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks."
11380451|NCT01404312|BG000|Baseline|RPT Plus INH Regimen (Arm A)|"Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.~Rifapentine (RPT): RPT dosing was based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily"
11380452|NCT01404312|BG001|Baseline|INH Regimen (Arm B)|"Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
11380453|NCT01404312|BG002|Baseline|Total|Total of all reporting groups
11380454|NCT01404312|FG000|Participant Flow|RPT Plus INH Regimen (Arm A)|"Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.~Rifapentine (RPT): RPT dosing was based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily"
11380455|NCT01404312|FG001|Participant Flow|INH Regimen (Arm B)|"Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
11380456|NCT01404312|OG000|Outcome|RPT Plus INH Regimen (Arm A)|"Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.~Rifapentine (RPT): RPT dosing was based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily."
10781688|NCT02435173|EG003|Reported Event|Part I: Total|Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
10781689|NCT02435173|EG004|Reported Event|Part II: CDZ173 70 mg|Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
10781690|NCT02435173|EG005|Reported Event|Part II: Placebo|Participants received Placebo b.i.d. from Day 1 to Day 85.
10850616|NCT00303628|BG000|Baseline|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
10781691|NCT02390245|BG000|Baseline|Telemedicine Screening Participants - Phase 1|Phase 1: Participants from geographically underserved locations across the Philadelphia, PA region were invited to participate in a free glaucoma eye screening at their primary care physician offices or health centers which included taking images of optic nerve and macula using a non-contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) and measuring Intraocular Pressure (IOP) in millimeters of mercury (mm Hg) with a non-contact rebound tonometer TA01I (ICare, Helsinki, Finland). Visual acuity was measured with correction, if patient had glasses or contact lenses, using the digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA) and medical, family and ocular history were recorded
10781692|NCT02390245|FG000|Participant Flow|Telemedicine Screening Participants - Phase 1|"Phase I Participants recruited from diverse underserved locations across the Philadelphia region were invited for a free eye screening Visit 1 conducted at 14 locations by study team.~Screenings consisted of noncontact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) to detect abnormalities on optic nerve and macula. Trained ocular technicians captured 2 posterior and 1 anterior images per eye (6 photographs).~Intraocular pressure (IOP) in millimeters of mercury (mm Hg) was assessed with noncontact rebound tonometer TA01I (ICare, Helsinki, Finland). Single IOP taken for each eye. If IOP > 22 mm Hg, second IOP taken of that eye. If difference between 2 measurements < 2 mm Hg, average recorded. If difference between 2 measurements > 2 mm Hg, third measurement obtained, and median recorded.~Visual acuity measured with correction, if patient had glasses or contact lenses, using digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA).~Medical, family and ocular history recorded. Participants with suspicious findings, high eye pressure or unreadable images were invited back for complete eye examination Visit 2 at primary care physician offices to confirm diagnosis. If final IOP > 30 mm Hg, participant Fast Tracked to Visit 2."
10781693|NCT02390245|FG001|Participant Flow|Enhanced Intervention Group - Phases 2/3|"Phase II Included confirmation dilated eye exam (Visit 2) for qualifying participants with ocular hypertension or glaucoma. Participants were randomized into an Enhanced Intervention Group then referred to a general ophthalmologist for follow-up eye care. The Enhanced Intervention Group was assigned a patient navigator and social worker and scheduled for an initial follow-up visit based on recommendations from study physicians at Visit 2. Prior to all follow-up visits, participants were given a scheduled appointment and received personal phone call reminders. Patients received necessary interpretation services and educational materials.~Phase III consisted of tracking the Enhanced Intervention Group for compliance of attending recommended ophthalmic visits after Visit 2 during a 5 year period. Tracking was performed by the research team."
10781694|NCT02390245|FG002|Participant Flow|Usual Care Group - Phases 2/3|"Phase II Included confirmation dilated eye exam (Visit 2) for qualifying participants with ocular hypertension or glaucoma. Participants were randomized into a Usual Care Group then referred to a general ophthalmologist for follow-up eye care. The Usual Care Group was scheduled for an initial follow-up visit based on recommendations from study physicians at Visit 2. This option represents a realistic choice currently available to patients. Practice patterns vary depending on resources, staff time, and services available within each local ophthalmology practice.~Phase III consisted of tracking the Usual Care Group for compliance of attending recommended ophthalmic visits after Visit 2 during a 5 year period. Tracking was performed by the research team."
10781695|NCT02390245|OG000|Outcome|Telemedicine Screening Participants|"Phase I. Participants recruited from diverse underserved locations across the Philadelphia region from community partners. Community partners included Public Health Management Corporation (4 centers), Philadelphia Department of Public Health (1 center), Health Federation of Philadelphia (2 centers), and Temple Physicians Inc (7 primary care offices). Offices and health centers selected based on zip code.~Screenings consisted of a non contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) to center images on the optic nerve and macula. Trained ocular technicians captured 2 posterior and 1 anterior images per eye (6 total photographs).~Intraocular pressure (IOP) in millimeters of mercury (mm Hg) was assessed with non contact rebound tonometer TA01I (ICare, Helsinki, Finland). Single IOP taken for each eye. If IOP > 22 mm Hg, a second IOP was taken of that eye. If difference between 2 measurements < 2 mm Hg, average was recorded. If difference between 2 measurements > 2 mm Hg, a third measurement was obtained, and median was recorded. If final IOP > 30 mm Hg, participant was Fast Tracked to Visit 2.~Visual acuity measured with correction, if patient had glasses or contact lenses, using the digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA).~Medical, family and ocular history were recorded."
10781696|NCT02390245|OG000|Outcome|Telemedicine Screening Participants|Phase I. Participants with suspicious findings, high eye pressure or unreadable images from the telemedicine screening Visit 1 were referred for a complete dilated eye examination and visual field by study team and Ophthalmologist at Visit 2 within 6 months.
10781697|NCT02390245|EG000|Reported Event|Phase 1: Telemedicine Screening Participants|Phase 1. 906 participants completed telemedicine screening with non contact fundus images, non contact intraocular pressure measurements, visual acuity and history recorded.
10781698|NCT02390245|EG001|Reported Event|Phases 2/3: Enhanced Intervention Group|"Phase 2. 171 participants completing Visit 2 then randomized to the Enhanced Intervention Group for follow-up eye care.~Phase 3. Includes following this group over a 5 year period for adherence to eye care."
10781699|NCT02390245|EG002|Reported Event|Phases 2/3: Usual Care Group|"Phase 2. 171 participants completing Visit 2 then randomized to the Usual Care Group for follow-up eye care.~Phase 3. Includes following this group over a 5 year period for adherence to eye care."
10781700|NCT02254278|BG000|Baseline|IMRT 6 Weeks + Cisplatin|"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks~IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781701|NCT02254278|BG001|Baseline|IMRT 5 Weeks|IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
10964553|NCT00878189|OG007|Outcome|PF-03084014 330 mg BID in Solid Tumor Participants|PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10781702|NCT02254278|BG002|Baseline|Total|Total of all reporting groups
10781703|NCT02254278|FG000|Participant Flow|IMRT 6 Weeks + Cisplatin|"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks~IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781704|NCT02254278|FG001|Participant Flow|IMRT 5 Weeks|IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
10781705|NCT02254278|OG000|Outcome|IMRT 6 Weeks + Cisplatin (Arm 1)|"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks~IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781706|NCT02254278|OG001|Outcome|IMRT 5 Weeks (Arm 2)|IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
10781707|NCT02254278|OG000|Outcome|IMRT 6 Weeks + Cisplatin|"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks~IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781708|NCT02254278|OG001|Outcome|IMRT 5 Weeks|IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
10781709|NCT02254278|OG000|Outcome|Both Arms Combined|"IMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy.~IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781710|NCT02254278|EG000|Reported Event|IMRT 6 Weeks + Cisplatin|"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks~IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy"
10781711|NCT02254278|EG001|Reported Event|IMRT 5 Weeks|IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
10964554|NCT00878189|OG000|Outcome|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964555|NCT00878189|OG000|Outcome|PF-03084014 20 mg BID in Solid Tumor Participants|PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964556|NCT00878189|OG008|Outcome|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964557|NCT00878189|OG000|Outcome|PF-03084014 in Solid Tumor Participants|PF-03084014 20, 40, 80, 100, 150, 220, 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964558|NCT00878189|OG001|Outcome|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964559|NCT00878189|OG007|Outcome|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964560|NCT00878189|OG000|Outcome|PF-03084014 150 mg BID in Solid Tumor Participants|"PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either fed or fasted conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions."
10964561|NCT00878189|OG001|Outcome|PF-03084014 220 mg BID in Solid Tumor Participants|"PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either fed or fasted conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions."
10964562|NCT00878189|OG000|Outcome|PF-03084014 in Solid Tumor Participants|"PF-03084014 150 mg or 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either fed or fasted conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions."
10964563|NCT00878189|OG000|Outcome|PF-03084014 150 mg BID in Solid Tumor Participants|PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11380457|NCT01404312|OG001|Outcome|INH Regimen (Arm B)|"Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
11380458|NCT01404312|OG000|Outcome|INH Regimen (Arm B)|"Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
10781723|NCT01673867|BG000|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781724|NCT01673867|BG001|Baseline|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781725|NCT01673867|BG002|Baseline|Total|Total of all reporting groups
10781726|NCT01673867|FG000|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781727|NCT01673867|FG001|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781728|NCT01673867|OG000|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
11380459|NCT01404312|EG000|Reported Event|RPT Plus INH Regimen (Arm A)|"Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.~Rifapentine (RPT): RPT dosing was based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets)."
10781729|NCT01673867|OG001|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781730|NCT01673867|EG000|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781731|NCT01673867|EG001|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10781732|NCT01182727|BG000|Baseline|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
10850617|NCT00303628|BG001|Baseline|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
10850618|NCT00303628|BG002|Baseline|Total|Total of all reporting groups
10850619|NCT00303628|FG000|Participant Flow|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
10850620|NCT00303628|FG001|Participant Flow|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
10850621|NCT00303628|OG000|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
10781733|NCT01182727|FG000|Participant Flow|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
10781734|NCT01182727|OG000|Outcome|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
10781735|NCT01182727|EG000|Reported Event|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
10781736|NCT00335777|BG000|Baseline|Migranal: All Subjects|All subjects enrolled in study
10781737|NCT00335777|FG000|Participant Flow|Migranal: All Subjects|All subjects enrolled in study
10781738|NCT00335777|OG000|Outcome|Migranal: Early Treatment|Treated headache within 1.25 hours of onset of throbbing
10781739|NCT00335777|OG001|Outcome|Migranal Late Treatment|Treated a headache at greater or equal to 3.5 hours after onset of throbbing
10781740|NCT00335777|EG000|Reported Event|Migranal: All Subjects|All subjects enrolled in study
10781741|NCT00159588|BG000|Baseline|Preventive Drugs From the Start|Preventive medication started day 1 without explicit advice of withdrawal of overused medication
10781742|NCT00159588|BG001|Baseline|Abrupt Withdrawal|Standard out-patient detoxication program
10781743|NCT00159588|BG002|Baseline|Controls|Did not get a new preventive medication or direct advice to stop use of analgesics
10781744|NCT00159588|BG003|Baseline|Total|Total of all reporting groups
10781745|NCT00159588|FG000|Participant Flow|Preventive Drugs From the Start|Use of preventive drugs from the start without abrupt withdrawal. This group was not explicitly advised to withdraw overused medication. Preventive medication was started on day 1, based on a priority list of medicines (Betablockers, candesartan, topiramate, amitriptyline or other preventive relevant drugs. For each patient preventive agent was chosen on the basis of a list of specifications considering the primary headache, side-effects of the drug and what they have tried before.
10781746|NCT00159588|FG001|Participant Flow|Abrupt Withdrawal|Device: Abrupt withdrawal
10781747|NCT00159588|FG002|Participant Flow|Controls|Active control: No instruction for abrupt withdrawal or prophylactic treatment
10781748|NCT00159588|OG000|Outcome|Prophylaxis From the Start|"Use of preventive drugs from the start without abrupt withdrawal~Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)"
10781749|NCT00159588|OG001|Outcome|Abrupt Withdrawal|"Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week~Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)"
10781750|NCT00159588|OG002|Outcome|Controls|"Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment~Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)"
10781751|NCT00159588|OG000|Outcome|Preventive Drugs From the Start|"Use of preventive drugs from the start without abrupt withdrawal~Betablockers or other preventive drugs: Several preventive drugs based on each individual"
10781752|NCT00159588|OG001|Outcome|Abrupt Withdrawal|Device: Abrupt withdrawal
10781753|NCT00159588|OG002|Outcome|Controls|Active control: No instruction for abrupt withdrawal or prophylactic treatment
10781754|NCT00159588|EG000|Reported Event|Preventive Drugs From the Start|"Use of preventive drugs from the start without abrupt withdrawal~Betablockers or other preventive drugs: Several preventive drugs based on each individual"
10781755|NCT00159588|EG001|Reported Event|Abrupt Withdrawal|Device: Abrupt withdrawal
10781756|NCT00159588|EG002|Reported Event|Controls|Active control: No instruction for abrupt withdrawal or prophylactic treatment
10781757|NCT03051217|BG000|Baseline|Placebo|This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.
10781758|NCT03051217|BG001|Baseline|CZP 200 mg Q2W|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.
10781759|NCT03051217|BG002|Baseline|CZP 400 mg Q2W|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.
10781760|NCT03051217|BG003|Baseline|Total Title|
10781761|NCT03051217|FG000|Participant Flow|Placebo|This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.
10781762|NCT03051217|FG001|Participant Flow|CZP 200 mg Q2W|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.
10781763|NCT03051217|FG002|Participant Flow|CZP 400 mg Q2W|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.
10781764|NCT03051217|FG003|Participant Flow|Placebo/Placebo|This arm consisted of participants who were initially randomized to Placebo during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive Placebo during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
10781765|NCT03051217|FG004|Participant Flow|CZP 400 mg Q2W/CZP 400 mg Q2W|This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
10781766|NCT03051217|FG005|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W|This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
10781767|NCT03051217|FG006|Participant Flow|CZP 200 mg Q2W/CZP 400 mg Q4W|This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
10781768|NCT03051217|OG000|Outcome|Placebo (FAS)|This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
10781769|NCT03051217|OG001|Outcome|CZP 200 mg Q2W (FAS)|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
10781770|NCT03051217|OG002|Outcome|CZP 400 mg Q2W (FAS)|This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
10781771|NCT03051217|OG000|Outcome|CZP 200 mg Q2W/CZP 200 mg Q2W (PK-PPS)|This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
10781772|NCT03051217|OG001|Outcome|CZP 400 mg Q2W/CZP 400 mg Q2W (PK-PPS)|This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.
10781773|NCT03051217|OG002|Outcome|CZP 200 mg Q2W/CZP 400 mg Q4W (PK-PPS)|This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.
10781774|NCT03051217|EG000|Reported Event|Placebo (SS)|This arm consisted of participants who received at least one dose of Placebo subcutaneous (sc) injection every two weeks (Q2W) during the study. Participants formed the Safety Set (SS).
10781775|NCT03051217|EG001|Reported Event|CZP 200mg Q2W (SS)|This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) during the study. Participants formed the SS.
10781776|NCT03051217|EG002|Reported Event|CZP 400mg Q4W (SS)|This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
11339872|NCT03640052|FG001|Participant Flow|LTM1201L First|LTM1201L administered before sleep for 1 night, followed by LTM1201LD, LTM1201LN, LTM1201LB and Placebo, administered 1 week apart in the hospital
10781777|NCT03051217|EG003|Reported Event|CZP 200 mg Q2W + CZP 400 mg Q4W (SS)|This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) and at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
10781778|NCT03051217|EG004|Reported Event|CZP 400 mg Q2W (SS)|This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the study. Participants formed the SS.
10781779|NCT03051217|EG005|Reported Event|All CZP (SS)|This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection regardless of the dose during the study. Participants formed the SS.
10781780|NCT03025542|BG000|Baseline|Bimekizumab + PBO|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.
10781781|NCT03025542|BG001|Baseline|Bimekizumab|Bimekizumab administered sc at Baseline and Weeks 4 and 16.
10781782|NCT03025542|BG002|Baseline|Total Title|
10781783|NCT03025542|FG000|Participant Flow|Bimekizumab + PBO|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.
10781784|NCT03025542|FG001|Participant Flow|Bimekizumab|Bimekizumab administered sc at Baseline and Weeks 4 and 16.
10781785|NCT03025542|OG000|Outcome|Bimekizumab + PBO (FAS)|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).
10781786|NCT03025542|OG001|Outcome|Bimekizumab (FAS)|Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
10781787|NCT03025542|OG000|Outcome|Bimekizumab + PBO (PK-PPS)|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
10781788|NCT03025542|OG001|Outcome|Bimekizumab (PK-PPS)|Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
10781789|NCT03025542|OG000|Outcome|Bimekizumab + PBO (SS)|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).
10781790|NCT03025542|OG001|Outcome|Bimekizumab (SS)|Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
10781791|NCT03025542|EG000|Reported Event|Bimekizumab + PBO (SS)|Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).
10781792|NCT03025542|EG001|Reported Event|Bimekizumab (SS)|Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
10781793|NCT02958319|BG000|Baseline|Anti P Carb Negative RA Patients|RA patients negative for antibodies against the carbamylated proteins
10781794|NCT02958319|BG001|Baseline|Anti P Carb Positive RA Patients|RA patients positive for antibodies against the carbamylated proteins
10781795|NCT02958319|BG002|Baseline|Total|Total of all reporting groups
10781796|NCT02958319|FG000|Participant Flow|Anti P Carb Negative RA Patients|RA patients negative for antibodies against the carbamylated proteins
10781797|NCT02958319|FG001|Participant Flow|Anti P Carb Positive RA Patients|RA patients positive for antibodies against the carbamylated proteins
10781798|NCT02958319|OG000|Outcome|Anti P Carb Negative RA Patients|RA patients negative for antibodies against the carbamylated proteins
10781799|NCT02958319|OG001|Outcome|Anti P Carb Positive RA Patients|RA patients positive for antibodies against the carbamylated proteins
10781800|NCT02958319|EG000|Reported Event|Anti P Carb Negative RA Patients|RA patients negative for antibodies against the carbamylated proteins
10781801|NCT02958319|EG001|Reported Event|Anti P Carb Positive RA Patients|RA patients positive for antibodies against the carbamylated proteins
10781802|NCT02929069|BG000|Baseline|ESTEEM|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~VCT: Voluntary Counselling and Testing (VCT)."
10781803|NCT02929069|BG001|Baseline|Voluntary Counselling and Testing (VCT)|"Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.~VCT: Voluntary Counselling and Testing (VCT)."
10781804|NCT02929069|BG002|Baseline|Community Mental Health Treatment (CMHT)|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~VCT: Voluntary Counselling and Testing (VCT)."
10781805|NCT02929069|BG003|Baseline|Total|Total of all reporting groups
11193858|NCT02148302|FG000|Participant Flow|Harvesting Device (CelluTome©)|"open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.~Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.~A run-in period of two weeks followed by twelve weeks of active treatment~Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone."
10781806|NCT02929069|FG000|Participant Flow|ESTEEM|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~VCT: Voluntary Counselling and Testing (VCT)."
10781807|NCT02929069|FG001|Participant Flow|Community Mental Health Treatment (CMHT)|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~VCT: Voluntary Counselling and Testing (VCT)."
10781808|NCT02929069|FG002|Participant Flow|Voluntary Counselling and Testing (VCT)|"Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.~VCT: Voluntary Counselling and Testing (VCT)."
10781809|NCT02929069|OG000|Outcome|ESTEEM|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~VCT: Voluntary Counselling and Testing (VCT)."
10781810|NCT02929069|OG001|Outcome|Community Mental Health Treatment (CMHT)|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~VCT: Voluntary Counselling and Testing (VCT)."
10781811|NCT02929069|OG002|Outcome|Voluntary Counselling and Testing (VCT)|"Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.~VCT: Voluntary Counselling and Testing (VCT)."
10781812|NCT02929069|OG001|Outcome|Voluntary Counselling and Testing (VCT)|"Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.~VCT: Voluntary Counselling and Testing (VCT)."
10781813|NCT02929069|OG002|Outcome|Community Mental Health Treatment (CMHT)|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~VCT: Voluntary Counselling and Testing (VCT)."
10781814|NCT02929069|EG000|Reported Event|ESTEEM|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.~VCT: Voluntary Counselling and Testing (VCT)."
10781815|NCT02929069|EG001|Reported Event|Voluntary Counselling and Testing (VCT)|"Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.~VCT: Voluntary Counselling and Testing (VCT)."
10781816|NCT02929069|EG002|Reported Event|Community Mental Health Treatment (CMHT)|"Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.~VCT: Voluntary Counselling and Testing (VCT)."
10781817|NCT02889809|BG000|Baseline|Placebo|Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10850907|NCT03999554|FG004|Participant Flow|Placebo|"Saline will be administered intranasally on days 1 and 29~Placebo: This group will receive saline placebo administered intranasally."
11193859|NCT02148302|FG001|Participant Flow|Control: SOC Alone|The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
11339873|NCT03640052|FG002|Participant Flow|LTM1201LD First|LTM1201LD administered before sleep for 1 night, followed by LTM1201LN, LTM1201LB, Placebo and LTM1201L, administered 1 week apart in the hospital
11339874|NCT03640052|FG003|Participant Flow|LTM1201LN First|LTM1201LN administered before sleep for 1 night, followed by LTM1201LB, Placebo, LTM1201L and LTM1201LD administered 1 week apart in the hospital
11339875|NCT03640052|FG004|Participant Flow|LTM1201LB First|LTM1201LB administered before sleep for 1 night, followed by Placebo, LTM1201L, LTM1201LD and LTM1201LN administered 1 week apart in the hospital
11339876|NCT03640052|OG000|Outcome|Placebo|"Placebo capsule 1 time before bedtime~Placebo oral capsule: Placebo capsule before sleep"
10781818|NCT02889809|BG001|Baseline|FF 50 mcg|Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781819|NCT02889809|BG002|Baseline|Total|Total of all reporting groups
10781820|NCT02889809|FG000|Participant Flow|Placebo|Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781821|NCT02889809|FG001|Participant Flow|FF 50 mcg|Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781822|NCT02889809|OG000|Outcome|Placebo|Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
11193860|NCT02148302|OG000|Outcome|Harvesting Device (CelluTome©)|"open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.~Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.~A run-in period of two weeks followed by twelve weeks of active treatment~Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone."
10781823|NCT02889809|OG001|Outcome|FF 50 mcg|Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781824|NCT02889809|EG000|Reported Event|Placebo|Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781825|NCT02889809|EG001|Reported Event|FF 50 mcg|Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.
10781826|NCT02849587|BG000|Baseline|Placebo|Cannabis with .02% THC
10781827|NCT02849587|BG001|Baseline|5.9% THC|Cannabis with 5.9% THC
10781828|NCT02849587|BG002|Baseline|13.4% THC|Cannabis with 13.4% THC
10781829|NCT02849587|BG003|Baseline|Total|Total of all reporting groups
10781830|NCT02849587|FG000|Participant Flow|Placebo Cannabis|Participants will smoke placebo cannabis with .02% THC ad libitum
10781831|NCT02849587|FG001|Participant Flow|Cannabis With 5.9% THC|Participants will smoke cannabis with 5.9% THC ad libitum
11193861|NCT02148302|OG001|Outcome|Control: SOC Alone|The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
10781832|NCT02849587|FG002|Participant Flow|Cannabis With 13.4% THC|Participants will smoke placebo cannabis with 13.4% THC ad libitum
10781833|NCT02849587|OG000|Outcome|Placebo|Placebo Cannabis
10781834|NCT02849587|OG001|Outcome|5.9% THC|Cannabis with 5.9% THC
11193862|NCT02148302|EG000|Reported Event|Harvesting Device (CelluTome©)|"open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.~Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.~A run-in period of two weeks followed by twelve weeks of active treatment~Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone."
11193863|NCT02148302|EG001|Reported Event|Control: SOC Alone|The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN).
11339877|NCT03640052|OG001|Outcome|LTM1201L|"LTM1201L capsule 1 time before bedtime~LTM1201L: LTM1201L capsule before sleep"
11339878|NCT03640052|OG002|Outcome|LTM1201LN|"LTM1201LN capsule 1 time before bedtime~LTM1201LN: LTM1201LN capsule before sleep"
11339879|NCT03640052|OG003|Outcome|LTM1201LB|"LTM1201LB capsule 1 time before bedtime~LTM1201LB: LTM1201LB capsule before sleep"
10781835|NCT02849587|OG002|Outcome|13.4% THC|Cannabis with 13.4% THC
10781836|NCT02849587|OG001|Outcome|5.9% THC|Cannabis with 13.4% THC
10781837|NCT02849587|OG000|Outcome|Placebo|Placebo cannabis
10781838|NCT02849587|OG001|Outcome|5.9% THC|Participants smoking 5.9% THC cannabis
10781839|NCT02849587|OG002|Outcome|13.4% THC|Group smoking 13.4% THC
10781840|NCT02849587|EG000|Reported Event|Placebo Cannabis|Placebo Cannabis (.02% THC)
10781841|NCT02849587|EG001|Reported Event|Cannabis With 5.9% THC|Cannabis with 5.9% THC, smoked ad libitum
10781842|NCT02849587|EG002|Reported Event|Cannabis With 13.4% THC|Cannabis with 13.4% THC, smoked ad libitum
10781843|NCT02815540|BG000|Baseline|Observational|"This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.~12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring~Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol."
10781844|NCT02815540|FG000|Participant Flow|Observational|"This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.~12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring~Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol."
10781845|NCT02815540|OG000|Outcome|Observational|"This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.~12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring~Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol."
10781846|NCT02815540|EG000|Reported Event|Observational|"This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.~12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring~Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol."
10781847|NCT02814708|BG000|Baseline|Dose Group 1|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781848|NCT02814708|BG001|Baseline|Dose Group 2|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781849|NCT02814708|BG002|Baseline|Dose Group 3|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781850|NCT02814708|BG003|Baseline|Dose Group 4|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781851|NCT02814708|BG004|Baseline|Dose Group 5|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10850622|NCT00303628|OG001|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
10781852|NCT02814708|BG005|Baseline|Dose Group 6|"rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781853|NCT02814708|BG006|Baseline|Dose Group 7|"Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781854|NCT02814708|BG007|Baseline|Total|Total of all reporting groups
10781855|NCT02814708|FG000|Participant Flow|Dose Group 1|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781856|NCT02814708|FG001|Participant Flow|Dose Group 2|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781857|NCT02814708|FG002|Participant Flow|Dose Group 3|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781858|NCT02814708|FG003|Participant Flow|Dose Group 4|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781859|NCT02814708|FG004|Participant Flow|Dose Group 5|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781860|NCT02814708|FG005|Participant Flow|Dose Group 6|"rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10803741|NCT02255656|EG002|Reported Event|Alemtuzumab|All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
11193864|NCT02148445|BG000|Baseline|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
11193865|NCT02148445|BG001|Baseline|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
11193866|NCT02148445|BG002|Baseline|Total|Total of all reporting groups
11193867|NCT02148445|FG000|Participant Flow|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
10781861|NCT02814708|FG006|Participant Flow|Dose Group 7|"Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781862|NCT02814708|OG000|Outcome|Dose Group 1|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781863|NCT02814708|OG001|Outcome|Dose Group 2|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781864|NCT02814708|OG002|Outcome|Dose Group 3|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781865|NCT02814708|OG003|Outcome|Dose Group 4|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781866|NCT02814708|OG004|Outcome|Dose Group 5|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781867|NCT02814708|OG005|Outcome|Dose Group 6|"rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781868|NCT02814708|OG006|Outcome|Dose Group 7|"Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781869|NCT02814708|EG000|Reported Event|Dose Group 1|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10850623|NCT00303628|EG000|Reported Event|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity.
11193868|NCT02148445|FG001|Participant Flow|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
11193869|NCT02148445|OG000|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
11339880|NCT03640052|OG004|Outcome|LTM1201LD|"LTM1201LD capsule 1 time before bedtime~LTM1201LD: LTM1201LD capsule before sleep"
10781870|NCT02814708|EG001|Reported Event|Dose Group 2|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781871|NCT02814708|EG002|Reported Event|Dose Group 3|"rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781872|NCT02814708|EG003|Reported Event|Dose Group 4|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781873|NCT02814708|EG004|Reported Event|Dose Group 5|"rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781874|NCT02814708|EG005|Reported Event|Dose Group 6|"rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781875|NCT02814708|EG006|Reported Event|Dose Group 7|"Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3~rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer ."
10781876|NCT02781727|BG000|Baseline|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
11193870|NCT02148445|OG001|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
10781877|NCT02781727|BG001|Baseline|Daily hGH|Once daily subcutaneous injection of Genotropin
11339881|NCT03640052|EG000|Reported Event|Placebo|"Placebo capsule 1 time before bedtime~Placebo oral capsule: Placebo capsule before sleep"
10781878|NCT02781727|BG002|Baseline|Total|Total of all reporting groups
10781879|NCT02781727|FG000|Participant Flow|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
10781880|NCT02781727|FG001|Participant Flow|Daily hGH|Once daily subcutaneous injection of Genotropin
10781881|NCT02781727|OG000|Outcome|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
10781882|NCT02781727|OG001|Outcome|Daily hGH|Once daily subcutaneous injection of Genotropin
10781883|NCT02781727|EG000|Reported Event|Lonapegsomatropin|Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
10781884|NCT02781727|EG001|Reported Event|Daily hGH|Once daily subcutaneous injection of Genotropin
10781885|NCT02778204|BG000|Baseline|Cohort 1 Stratum 1A|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
10781886|NCT02778204|BG001|Baseline|Cohort 1 Stratum 1B|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
11339882|NCT03640052|EG001|Reported Event|LTM1201L|"LTM1201L capsule 1 time before bedtime~LTM1201L: LTM1201L capsule before sleep"
11339883|NCT03640052|EG002|Reported Event|LTM1201LN|"LTM1201LN capsule 1 time before bedtime~LTM1201LN: LTM1201LN capsule before sleep"
10781887|NCT02778204|BG002|Baseline|Cohort 2 Stratum 2A|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
10781888|NCT02778204|BG003|Baseline|Cohort 2 Stratum 2B|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
10781889|NCT02778204|BG004|Baseline|Total|Total of all reporting groups
10781890|NCT02778204|FG000|Participant Flow|Cohort 1 Stratum 1A|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
10781891|NCT02778204|FG001|Participant Flow|Cohort 1 Stratum 1B|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
10781892|NCT02778204|FG002|Participant Flow|Cohort 2 Stratum 2A|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
10781893|NCT02778204|FG003|Participant Flow|Cohort 2 Stratum 2B|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
10781894|NCT02778204|OG000|Outcome|Cohort 1 Stratum 1A|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
10781895|NCT02778204|OG001|Outcome|Cohort 1 Stratum 1B|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
10781896|NCT02778204|OG002|Outcome|Cohort 2 Stratum 2A|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
10781897|NCT02778204|OG003|Outcome|Cohort 2 Stratum 2B|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
10781898|NCT02778204|OG000|Outcome|Cohort 2 Stratum 2A|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
11193871|NCT02148445|OG000|Outcome|Standard Smoking Cessation|"Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.~Standard Smoking Cessation: Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.~Nicotine replacement therapy"
10781899|NCT02778204|OG001|Outcome|Cohort 2 Stratum 2B|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
10781900|NCT02778204|EG000|Reported Event|Cohort 1 Stratum 1A|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
10781901|NCT02778204|EG001|Reported Event|Cohort 1 Stratum 1B|Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
10781902|NCT02778204|EG002|Reported Event|Cohort 2 Stratum 2A|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
10781903|NCT02778204|EG003|Reported Event|Cohort 2 Stratum 2B|Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
10801581|NCT03529773|FG023|Participant Flow|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801582|NCT03529773|FG024|Participant Flow|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801583|NCT03529773|FG025|Participant Flow|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801584|NCT03529773|FG026|Participant Flow|Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10781904|NCT02743364|BG000|Baseline|Arm I (Simvastatin)|"Patients receive simvastatin PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Simvastatin: Given PO"
10781905|NCT02743364|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10781906|NCT02743364|BG002|Baseline|Total|Total of all reporting groups
10781907|NCT02743364|FG000|Participant Flow|Arm I (Simvastatin)|"Patients receive simvastatin PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Simvastatin: Given PO"
10781908|NCT02743364|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10781909|NCT02743364|OG000|Outcome|Arm I (Simvastatin)|"Patients receive simvastatin PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Simvastatin: Given PO"
10781910|NCT02743364|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10781911|NCT02743364|EG000|Reported Event|Arm I (Simvastatin)|"Patients receive simvastatin PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Simvastatin: Given PO"
10781912|NCT02743364|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10781913|NCT02496611|BG000|Baseline|Weight Loss Maintenance Without Pharmacotherapy|"A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trail.~Meal Replacement Therapy: A short-term meal replacement induction period designed to achieve >5% BMI reduction in 1, 2, or 3 months."
10781914|NCT02496611|BG001|Baseline|Weight Loss Maintenance With Pharmacotherapy|"We hypothesize that adolescents with severe obesity receiving GLP-1RA treatment following a short-term meal replacement induction period will demonstrate superior maintenance of initial BMI reduction 52 weeks following randomization compared to those assigned to placebo (primary endpoint) and that a higher proportion of those assigned to GLP-1RA treatment vs. placebo will maintain ≥5% BMI reduction from baseline to the 52-week time point (secondary endpoint)~Exenatide extended-release for injectable suspension (BYDUREON™)"
10781915|NCT02496611|BG002|Baseline|Total|Total of all reporting groups
10781916|NCT02496611|FG000|Participant Flow|Weight Loss Maintenance Without Pharmacotherapy|A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and placebo.
10781917|NCT02496611|FG001|Participant Flow|Weight Loss Maintenance With Pharmacotherapy|A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and pharmacotherapy with Exenatide extended-release.
10781918|NCT02496611|OG000|Outcome|Weight Loss Maintenance Without Pharmacotherapy|"A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.~Individuals in this group were randomized to receive lifestyle management therapy with placebo."
10781919|NCT02496611|OG001|Outcome|Weight Loss Maintenance With Pharmacotherapy|"A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.~Individuals in this group were randomized to receive lifestyle management therapy with pharmacotherapy treatment with Exenatide extended-release."
10781920|NCT02496611|EG000|Reported Event|Weight Loss Maintenance Without Pharmacotherapy|"A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.~Individuals in this group were randomized to receive lifestyle maintenance therapy without pharmacotherapy.~Serious Adverse Events and Adverse Events were not reported during the meal replacement induction."
10781921|NCT02496611|EG001|Reported Event|Weight Loss Maintenance With Pharmacotherapy|"A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.~Individuals in this group were randomized to receive lifestyle maintenance therapy with pharmacotherapy.~Serious Adverse Events and Adverse Events were not reported during the meal replacement induction."
10781922|NCT02496611|EG002|Reported Event|Meal Replacement Induction|"A short-term (1-3 month) meal replacement induction period to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.~All individuals were enrolled into this group upon signing consent and determining eligibility.~Serious Adverse Events and Adverse Events were not reported during the meal replacement induction."
10801585|NCT03529773|FG027|Participant Flow|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10850624|NCT00303628|EG001|Reported Event|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I
11339884|NCT03640052|EG003|Reported Event|LTM1201LB|"LTM1201LB capsule 1 time before bedtime~LTM1201LB: LTM1201LB capsule before sleep"
11339885|NCT03640052|EG004|Reported Event|LTM1201LD|"LTM1201LD capsule 1 time before bedtime~LTM1201LD: LTM1201LD capsule before sleep"
10781923|NCT02245308|BG000|Baseline|Abstinence Reinforcement Therapy|"Participants assigned to this treatment arm will receive a tele-health intervention that combines:~Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.~Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.~Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.~Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date."
10781924|NCT02245308|BG001|Baseline|Control Group|Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
10781925|NCT02245308|BG002|Baseline|Total|Total of all reporting groups
10781926|NCT02245308|FG000|Participant Flow|Abstinence Reinforcement Therapy|"Participants assigned to this treatment arm will receive a tele-health intervention that combines:~Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.~Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.~Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.~Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date."
10781927|NCT02245308|FG001|Participant Flow|Control Group|Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
10781928|NCT02245308|OG000|Outcome|Abstinence Reinforcement Therapy|"Participants assigned to this treatment arm will receive a tele-health intervention that combines:~Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.~Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.~Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.~Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date."
10781929|NCT02245308|OG001|Outcome|Control Group|Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
10781930|NCT02245308|EG000|Reported Event|Abstinence Reinforcement Therapy|"Participants assigned to this treatment arm will receive a tele-health intervention that combines:~Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.~Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.~Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.~Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date."
10781931|NCT02245308|EG001|Reported Event|Control Group|Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
10801586|NCT03529773|FG028|Participant Flow|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
11193872|NCT02148445|OG001|Outcome|Extended Nicotine Replacement Therapy|"Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.~Extended Nicotine Replacement Therapy: Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.~Nicotine replacement therapy"
11193873|NCT02148445|EG000|Reported Event|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
10850908|NCT03999554|OG000|Outcome|Low Dose Bris10 M2SR|"Low dose Bris10 M2SR will be administered intranasally on days 1 and 29~LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11193874|NCT02148445|EG001|Reported Event|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
11193875|NCT02148523|BG000|Baseline|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10781949|NCT02177695|BG000|Baseline|Gemcitabine & Cisplatin|"Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles~Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781950|NCT02177695|BG001|Baseline|Dose Dense MVAC|"Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781951|NCT02177695|BG002|Baseline|Total|Total of all reporting groups
11339886|NCT03640507|BG000|Baseline|Chlorhexidine-alcohol|"Subjects will receive vaginal preparation with chlorhexidine-alcohol.~Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks."
11339887|NCT03640507|BG001|Baseline|Povidine-iodine|"Subjects will receive vaginal preparation with povidine-iodine.~Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks."
10781952|NCT02177695|FG000|Participant Flow|Gemcitabine & Cisplatin|"Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles~Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781953|NCT02177695|FG001|Participant Flow|Dose Dense MVAC|"Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781954|NCT02177695|OG000|Outcome|Gemcitabine & Cisplatin|"Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles~Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781955|NCT02177695|OG001|Outcome|Dose Dense MVAC|"Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781956|NCT02177695|OG000|Outcome|All Participants|Eligible participants that were evaluable for COXEN analysis
10781957|NCT02177695|OG000|Outcome|Gemcitabine and Cisplatin|"Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles~Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781958|NCT02177695|EG000|Reported Event|Gemcitabine and Cisplatin|"Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles~Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781959|NCT02177695|EG001|Reported Event|Dose Dense MVAC|"Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles~Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.~Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
10781960|NCT02145403|BG000|Baseline|Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2|Participants were administered 20 mg/m^2 of Carfilzomib on days 1, 2, 6 and 7.
10781961|NCT02145403|BG001|Baseline|Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2|Participants were administered 20 mg/m^2 on days 1 and 2; 27 mg/m^2 of Carfilzomib on days 6 and 7.
10781962|NCT02145403|BG002|Baseline|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2|Participants were administered 20 mg/m^2 on days 1 and 2; 36 mg/m^2 of Carfilzomib on days 6 and 7.
11193876|NCT02148523|BG001|Baseline|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193877|NCT02148523|BG002|Baseline|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193878|NCT02148523|BG003|Baseline|Total|Total of all reporting groups
11193879|NCT02148523|FG000|Participant Flow|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10781963|NCT02145403|BG003|Baseline|Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2|Participants were administered 20 mg/m^2 on days 1 and 2; 45 mg/m^2 of Carfilzomib on days 6 and 7.
10781964|NCT02145403|BG004|Baseline|Total|Total of all reporting groups
10781965|NCT02145403|FG000|Participant Flow|Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 1: Participants were administered 20 mg/m^2 of Carfilzomib on days +6 and +7.~Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis."
10781966|NCT02145403|FG001|Participant Flow|Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 2: Participants were administered 27 mg/m^2 of Carfilzomib on days +6 and +7.~Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis."
10781967|NCT02145403|FG002|Participant Flow|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 3: Participants were administered 36 mg/m^2 of Carfilzomib on days +6 and +7.~Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis."
10781968|NCT02145403|FG003|Participant Flow|Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 4: Participants were administered 45 mg/m^2 of Carfilzomib on days +6 and +7.~Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis."
10781969|NCT02145403|OG000|Outcome|Phase 1 Study Participants|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Dose Level 1, 2, 3, 4: Participants were administered 20, 27, 36, or 45 mg/m^2 of Carfilzomib on days +6 and +7, respectively.~Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis."
10781970|NCT02145403|OG000|Outcome|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV|Participants were administered 20 mg/m^2 on days 1 and 2; 36 mg/m^2 of Carfilzomib on days 6 and 7.
10781971|NCT02145403|OG000|Outcome|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2|Participants were administered 20 mg/m^2 on days 1 and 2; 36 mg/m^2 of Carfilzomib on days 6 and 7.
10781972|NCT02145403|OG000|Outcome|Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV|Participants were administered 20 mg/m^2 of Carfilzomib on days 1, 2, 6 and 7.
10781973|NCT02145403|OG001|Outcome|Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV|Participants were administered 20 mg/m^2 on days 1 and 2; 27 mg/m^2 of Carfilzomib on days 6 and 7.
10781974|NCT02145403|OG002|Outcome|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV|Participants were administered 20 mg/m^2 on days 1 and 2; 36 mg/m^2 of Carfilzomib on days 6 and 7.
10781975|NCT02145403|OG003|Outcome|Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV|Participants were administered 20 mg/m^2 on days 1 and 2; 45 mg/m^2 of Carfilzomib on days 6 and 7.
10781976|NCT02145403|EG000|Reported Event|Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 1: Participants were administered 20 mg/m^2 of Carfilzomib on days +6 and +7."
10781977|NCT02145403|EG001|Reported Event|Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 2: Participants were administered 27 mg/m^2 of Carfilzomib on days +6 and +7."
10781978|NCT02145403|EG002|Reported Event|Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 3: Participants were administered 36 mg/m^2 of Carfilzomib on days +6 and +7."
10781979|NCT02145403|EG003|Reported Event|Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV|"Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes.~Cohort 4: Participants were administered 45 mg/m^2 of Carfilzomib on days +6 and +7."
10781980|NCT02105636|BG000|Baseline|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
10781981|NCT02105636|BG001|Baseline|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
10781982|NCT02105636|BG002|Baseline|Total|Total of all reporting groups
10781983|NCT02105636|FG000|Participant Flow|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
10781984|NCT02105636|FG001|Participant Flow|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
10781985|NCT02105636|OG000|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
10781986|NCT02105636|OG001|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
10781987|NCT02105636|OG001|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigator's Choice.
10781988|NCT02105636|EG000|Reported Event|Nivolumab 3 mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
10781989|NCT02105636|EG001|Reported Event|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
10781990|NCT02038946|BG000|Baseline|Arm 1: Nivolumab|Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
10781991|NCT02038946|FG000|Participant Flow|Arm 1: Nivolumab|Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
10781992|NCT02038946|OG000|Outcome|Arm 1: Nivolumab|Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
10781993|NCT02038946|EG000|Reported Event|Nivolumab 3 mg/kg|Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
10781994|NCT01988571|BG000|Baseline|Arm 1 - Atorvastatin|"One 40 mg Atorvastatin tablet each morning by mouth for 24 months~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months."
10781995|NCT01988571|BG001|Baseline|Arm 2 - Placebo|"One placebo tablet each morning by mouth for 24 months.~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.~Placebo: One placebo tablet taken each morning orally for 24 months."
10781996|NCT01988571|BG002|Baseline|Total|Total of all reporting groups
10781997|NCT01988571|FG000|Participant Flow|Arm 1 - Atorvastatin|"One 40 mg Atorvastatin tablet each morning by mouth for 24 months~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months."
10781998|NCT01988571|FG001|Participant Flow|Arm 2 - Placebo|"One placebo tablet each morning by mouth for 24 months.~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.~Placebo: One placebo tablet taken each morning orally for 24 months."
10781999|NCT01988571|OG000|Outcome|Arm 1 - Atorvastatin|"One 40 mg Atorvastatin tablet each morning by mouth for 24 months~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months."
10782000|NCT01988571|OG001|Outcome|Arm 2 - Placebo|"One placebo tablet each morning by mouth for 24 months.~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.~Placebo: One placebo tablet taken each morning orally for 24 months."
10782001|NCT01988571|EG000|Reported Event|Arm 1 - Atorvastatin|"One 40 mg Atorvastatin tablet each morning by mouth for 24 months~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months."
11193880|NCT02148523|FG001|Participant Flow|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10782002|NCT01988571|EG001|Reported Event|Arm 2 - Placebo|"One placebo tablet each morning by mouth for 24 months.~Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.~Placebo: One placebo tablet taken each morning orally for 24 months."
10782007|NCT01332266|BG000|Baseline|Phase 1b: Cohort 1: Golvatinib 200 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 200 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10801587|NCT03529773|FG029|Participant Flow|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11193881|NCT02148523|FG002|Participant Flow|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10782008|NCT01332266|BG001|Baseline|Phase 1b: Cohort 2: Golvatinib 300 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782009|NCT01332266|BG002|Baseline|Phase 1b: Cohort 3: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782010|NCT01332266|BG003|Baseline|Phase 2: Arm 1: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782011|NCT01332266|BG004|Baseline|Phase 2: Arm 2: Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782012|NCT01332266|BG005|Baseline|Total|Total of all reporting groups
10782013|NCT01332266|FG000|Participant Flow|Phase 1b: Cohort 1: Golvatinib 200 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) received golvatinib 200 milligram (mg) tablets, orally, once daily (run-in period) and cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D), until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782014|NCT01332266|FG001|Participant Flow|Phase 1b: Cohort 2: Golvatinib 300 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782015|NCT01332266|FG002|Participant Flow|Phase 1b: Cohort 3: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782016|NCT01332266|FG003|Participant Flow|Phase 2: Arm 1: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782017|NCT01332266|FG004|Participant Flow|Phase 2: Arm 2: Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10850909|NCT03999554|OG001|Outcome|Placebo|"Saline will be administered intranasally on days 1 and 29~Placebo: This group will receive saline placebo administered intranasally."
11193882|NCT02148523|OG000|Outcome|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193883|NCT02148523|OG001|Outcome|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193884|NCT02148523|OG002|Outcome|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10782018|NCT01332266|OG000|Outcome|Phase 1b: Cohort 1: Golvatinib 200 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received 200 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782019|NCT01332266|OG001|Outcome|Phase 1b: Cohort 2: Golvatinib 300 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received 300 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782020|NCT01332266|OG002|Outcome|Phase 1b: Cohort 3: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received 400 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782021|NCT01332266|OG000|Outcome|Phase 2: Arm 1: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782022|NCT01332266|OG001|Outcome|Phase 2: Arm 2: Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782023|NCT01332266|OG001|Outcome|Phase 2: Arm 2: Cetuximab 400 mg/m^2|Participants with platinum-resistant squamous cell carcinoma of the head and neck received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After six cycles, at the discretion of the Investigator, participants experienced clinical benefit have continued for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782024|NCT01332266|EG000|Reported Event|Phase 1b: Cohort 1: Golvatinib 200 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 200 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782025|NCT01332266|EG001|Reported Event|Phase 1b: Cohort 2: Golvatinib 300 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782026|NCT01332266|EG002|Reported Event|Phase 1b: Cohort 3: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782027|NCT01332266|EG003|Reported Event|Phase 2: Arm 1: Golvatinib 400 mg + Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
10782028|NCT01332266|EG004|Reported Event|Phase 2: Arm 2: Cetuximab 400 mg/m^2|Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
11193885|NCT02148523|EG000|Reported Event|Weekly Adherence Report|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
10782029|NCT01150890|BG000|Baseline|Placebo|Participants received placebo intravenously at baseline and week 4.
10782030|NCT01150890|BG001|Baseline|Brodalumab 210 mg|Participants received 210 mg brodalumab intravenously at baseline and week 4.
10782031|NCT01150890|BG002|Baseline|Brodalumab 350 mg|Participants received 350 mg brodalumab intravenously at baseline and week 4.
10782032|NCT01150890|BG003|Baseline|Brodalumab 700 mg|Participants received 700 mg brodalumab intravenously at baseline and week 4.
10782033|NCT01150890|BG004|Baseline|Total|Total of all reporting groups
10782034|NCT01150890|FG000|Participant Flow|Placebo|Participants received placebo intravenously at baseline and week 4.
10782035|NCT01150890|FG001|Participant Flow|Brodalumab 210 mg|Participants received 210 mg brodalumab intravenously at baseline and week 4.
10782036|NCT01150890|FG002|Participant Flow|Brodalumab 350 mg|Participants received 350 mg brodalumab intravenously at baseline and week 4.
10782037|NCT01150890|FG003|Participant Flow|Brodalumab 700 mg|Participants received 700 mg brodalumab intravenously at baseline and week 4.
10782038|NCT01150890|OG000|Outcome|Placebo|Participants received placebo intravenously at baseline and week 4.
10782039|NCT01150890|OG001|Outcome|Brodalumab 210 mg|Participants received 210 mg brodalumab intravenously at baseline and week 4.
11193886|NCT02148523|EG001|Reported Event|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193887|NCT02148523|EG002|Reported Event|Usual Care|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
11193888|NCT02148588|BG000|Baseline|The Entire Cohort|All participants received a peripheral nerve block
10782040|NCT01150890|OG002|Outcome|Brodalumab 350 mg|Participants received 350 mg brodalumab intravenously at baseline and week 4.
10782041|NCT01150890|OG003|Outcome|Brodalumab 700 mg|Participants received 700 mg brodalumab intravenously at baseline and week 4.
10782042|NCT01150890|OG000|Outcome|Brodalumab 210 mg|Participants received 210 mg brodalumab intravenously at baseline and week 4.
10782043|NCT01150890|OG001|Outcome|Brodalumab 350 mg|Participants received 350 mg brodalumab intravenously at baseline and week 4.
10782044|NCT01150890|OG002|Outcome|Brodalumab 700 mg|Participants received 700 mg brodalumab intravenously at baseline and week 4.
10782045|NCT01150890|EG000|Reported Event|Placebo|Participants received placebo intravenously at baseline and week 4.
10782046|NCT01150890|EG001|Reported Event|Brodalumab 210 mg|Participants received 210 mg brodalumab intravenously at baseline and week 4.
10782047|NCT01150890|EG002|Reported Event|Brodalumab 350 mg|Participants received 350 mg brodalumab intravenously at baseline and week 4.
10782048|NCT01150890|EG003|Reported Event|Brodalumab 700 mg|Participants received 700 mg brodalumab intravenously at baseline and week 4.
10782049|NCT01140867|BG000|Baseline|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
10782050|NCT01140867|FG000|Participant Flow|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
10782051|NCT01140867|OG000|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
10782052|NCT01140867|EG000|Reported Event|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
10782053|NCT01137773|BG000|Baseline|Intensive IV Insulin|Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl
10782054|NCT01137773|BG001|Baseline|Convention Insulin Treatment|conventional (150-170 mg/dl, n = 20) glucose control
10782055|NCT01137773|BG002|Baseline|Total|Total of all reporting groups
10782056|NCT01137773|FG000|Participant Flow|Intensive IV Insulin|Patients received target glucose levels of 80-110 mg/dl
10782057|NCT01137773|FG001|Participant Flow|Conventional Insulin Treatment|Subjects received conventional (150-170 mg/dl) glucose control
10782058|NCT01137773|OG000|Outcome|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
10782059|NCT01137773|OG001|Outcome|Convention Insulin Treatment|conventional (150-170 mg/dl, n = 20) glucose control
10782060|NCT01137773|OG000|Outcome|Intensive IV Insulin|"Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl~Insulin: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
10782061|NCT01137773|OG001|Outcome|Conventional Insulin Treatment|"Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl~Conventional insulin treatment: All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
10782062|NCT01137773|EG000|Reported Event|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
10782063|NCT01137773|EG001|Reported Event|Convention Insulin Treatment|target glucose levels of 150-170 mg/dl
10782064|NCT01127256|BG000|Baseline|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
10782065|NCT01127256|BG001|Baseline|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
10782066|NCT01127256|BG002|Baseline|Total|Total of all reporting groups
10782067|NCT01127256|FG000|Participant Flow|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
10782068|NCT01127256|FG001|Participant Flow|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
10782069|NCT01127256|OG000|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
10782070|NCT01127256|OG001|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
10782071|NCT01127256|EG000|Reported Event|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
10782072|NCT01127256|EG001|Reported Event|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
10782073|NCT01004861|BG000|Baseline|Dose Escalation Cohort 1: 200 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.
10782074|NCT01004861|BG001|Baseline|Dose Escalation Cohort 2: 300 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.
10782075|NCT01004861|BG002|Baseline|Dose Escalation Cohort 3: 400 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.
10782076|NCT01004861|BG003|Baseline|Dose Escalation Cohort 4: 600 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.
10782077|NCT01004861|BG004|Baseline|Dose Escalation Cohort 5: 900 mg/Day|Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.
10782078|NCT01004861|BG005|Baseline|Dose Escalation Cohort 6: 1200 mg/Day|Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.
10782079|NCT01004861|BG006|Baseline|Dose Escalation Cohort 7: 1000 mg/Day|Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.
10782080|NCT01004861|BG007|Baseline|Dose Extension: MEC Cohort|Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.
10782081|NCT01004861|BG008|Baseline|Dose Extension: PVNS Cohort|Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
10782082|NCT01004861|BG009|Baseline|Dose Extension: GIST Cohort|Participants with advanced gastrointestinal stromal tumor (GIS) who received PLX3397.
10782083|NCT01004861|BG010|Baseline|Dose Extension: ATC Cohort|Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.
11193889|NCT02148588|FG000|Participant Flow|The Entire Cohort|All participants received a peripheral nerve block
10782084|NCT01004861|BG011|Baseline|Dose Extension: Malignant Effusion Cohort|Participants with advanced solid tumors with malignant effusion who received PLX3397.
10782085|NCT01004861|BG012|Baseline|Dose Extension: Other Solid Tumor Type Cohort|Participants with other solid tumor types who received PLX3397.
10782086|NCT01004861|BG013|Baseline|Total|Total of all reporting groups
11193890|NCT02148588|OG000|Outcome|The Entire Cohort|All participants received a peripheral nerve block
10782087|NCT01004861|FG000|Participant Flow|Dose Escalation Cohort 1: 200 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.
10782088|NCT01004861|FG001|Participant Flow|Dose Escalation Cohort 2: 300 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.
10782089|NCT01004861|FG002|Participant Flow|Dose Escalation Cohort 3: 400 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.
10782090|NCT01004861|FG003|Participant Flow|Dose Escalation Cohort 4: 600 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.
10782091|NCT01004861|FG004|Participant Flow|Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)|Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.
10782092|NCT01004861|FG005|Participant Flow|Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.
10782093|NCT01004861|FG006|Participant Flow|Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.
10782094|NCT01004861|FG007|Participant Flow|Dose Extension: MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced or recurrent mucoepidermoid carcinoma (MEC) who received PLX3397.
10782095|NCT01004861|FG008|Participant Flow|Dose Extension: PVNS Cohort PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
10782096|NCT01004861|FG009|Participant Flow|Dose Extension: GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.
10782097|NCT01004861|FG010|Participant Flow|Dose Extension: ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.
10782098|NCT01004861|FG011|Participant Flow|Dose Extension: Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced solid tumors with malignant effusion who received PLX3397.
10782099|NCT01004861|FG012|Participant Flow|Dose Extension: Other Tumors 1000 mg/Day (600mg AM, 400mg PM)|Participants with other solid tumor types who received PLX3397.
10782100|NCT01004861|OG000|Outcome|Dose Escalation Cohort 1: 200 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.
10782101|NCT01004861|OG001|Outcome|Dose Escalation Cohort 2: 300 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.
10782102|NCT01004861|OG002|Outcome|Dose Escalation Cohort 3: 400 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.
10782103|NCT01004861|OG003|Outcome|Dose Escalation Cohort 4: 600 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.
10782104|NCT01004861|OG004|Outcome|Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)|Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.
10782105|NCT01004861|OG005|Outcome|Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.
10782106|NCT01004861|OG006|Outcome|Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.
10782107|NCT01004861|OG007|Outcome|All Participants|All participants with advanced, incurable, solid tumors who received PL3397.
10782108|NCT01004861|OG000|Outcome|Dose Extension: MEC Cohort|Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.
10782109|NCT01004861|OG001|Outcome|Dose Extension: PVNS Cohort|Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
10782110|NCT01004861|OG002|Outcome|Dose Extension: GIST Cohort|Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.
11193891|NCT02148588|EG000|Reported Event|The Entire Cohort|All participants received a peripheral nerve block
11193892|NCT02148718|BG000|Baseline|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
10782111|NCT01004861|OG003|Outcome|Dose Extension: ATC Cohort|Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.
10782112|NCT01004861|OG004|Outcome|Dose Extension: Malignant Effusion Cohort|Participants with advanced solid tumors with malignant effusion who received PLX3397.
10782113|NCT01004861|OG005|Outcome|Dose Extension: Other Solid Tumor Type Cohort|Participants with other solid tumor types who received PLX3397.
10782114|NCT01004861|OG002|Outcome|Dose Extension: GIST Cohort|Participants with advanced gastrointestinal stromal tumor (GIS) who received PLX3397.
10782115|NCT01004861|OG000|Outcome|PVNS Cohort|Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
10782116|NCT01004861|OG000|Outcome|NRS for PVNS Symptoms Evaluable Population|Participants who were administered the NRS scale at baseline and monthly on treatment.
10782117|NCT01004861|EG000|Reported Event|Dose Escalation Cohort 1: 200 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.
10782118|NCT01004861|EG001|Reported Event|Dose Escalation Cohort 2: 300 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.
10782119|NCT01004861|EG002|Reported Event|Dose Escalation Cohort 3: 400 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.
10782120|NCT01004861|EG003|Reported Event|Dose Escalation Cohort 4: 600 mg QD|Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.
10782121|NCT01004861|EG004|Reported Event|Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)|Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.
10782122|NCT01004861|EG005|Reported Event|Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.
10782123|NCT01004861|EG006|Reported Event|Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)|Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.
10782124|NCT01004861|EG007|Reported Event|MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced or recurrent mucoepidermoid carcinoma (MEC) who received PLX3397.
10782125|NCT01004861|EG008|Reported Event|PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
11193893|NCT02148718|FG000|Participant Flow|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
10782126|NCT01004861|EG009|Reported Event|GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.
10782127|NCT01004861|EG010|Reported Event|ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.
10782128|NCT01004861|EG011|Reported Event|Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with advanced solid tumors with malignant effusion who received PLX3397.
10782129|NCT01004861|EG012|Reported Event|Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)|Participants with other solid tumor types who received PLX3397.
10782130|NCT00912223|BG000|Baseline|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
10782131|NCT00912223|FG000|Participant Flow|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
10782132|NCT00912223|OG000|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
10782133|NCT00912223|EG000|Reported Event|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
10782134|NCT00381381|BG000|Baseline|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
10782135|NCT00381381|FG000|Participant Flow|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
10782136|NCT00381381|OG000|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
10782137|NCT00381381|EG000|Reported Event|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
10782138|NCT00038675|BG000|Baseline|Imatinib Mesylate|Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
10782139|NCT00038675|FG000|Participant Flow|Imatinib Mesylate|Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
11193894|NCT02148718|OG000|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
11193895|NCT02148718|EG000|Reported Event|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
10782140|NCT00038675|OG000|Outcome|Imatinib Mesylate|Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
10782141|NCT00038675|EG000|Reported Event|Imatinib Mesylate|Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
10801588|NCT03529773|FG030|Participant Flow|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801589|NCT03529773|FG031|Participant Flow|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801590|NCT03529773|FG032|Participant Flow|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801591|NCT03529773|FG033|Participant Flow|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10782142|NCT04389333|BG000|Baseline|ncMCE Group|The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center [10]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
11380460|NCT01404312|EG001|Reported Event|INH Regimen (Arm B)|"Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily~INH Regimen (Arm B) Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
11380461|NCT01425008|BG000|Baseline|Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)|TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380462|NCT01425008|BG001|Baseline|Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)|TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380463|NCT01425008|BG002|Baseline|Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)|TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380464|NCT01425008|BG003|Baseline|Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)|TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380465|NCT01425008|BG004|Baseline|Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380466|NCT01425008|BG005|Baseline|Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)|TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380467|NCT01425008|BG006|Baseline|Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380468|NCT01425008|BG007|Baseline|QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)|TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380469|NCT01425008|BG008|Baseline|QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380470|NCT01425008|BG009|Baseline|QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)|TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380471|NCT01425008|BG010|Baseline|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380472|NCT01425008|BG011|Baseline|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380473|NCT01425008|BG012|Baseline|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380474|NCT01425008|BG013|Baseline|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380475|NCT01425008|BG014|Baseline|Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
11380476|NCT01425008|BG015|Baseline|Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
11380477|NCT01425008|BG016|Baseline|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
11380478|NCT01425008|BG017|Baseline|Q2D Dose Expansion Phase: TAK-580 (BRAF+)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
11380479|NCT01425008|BG018|Baseline|QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
10782143|NCT04389333|BG001|Baseline|MCE Group|The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
10782144|NCT04389333|BG002|Baseline|Total|Total of all reporting groups
10782145|NCT04389333|FG000|Participant Flow|Non-contact MCE Examination|"After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.~non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope."
10782146|NCT04389333|FG001|Participant Flow|MCE Examination|"After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or left lateral decubitus position and to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. Then, under the guidance of the endoscopist face to face, the subject turned over on the bed to complete the examination.~non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope."
10782147|NCT04389333|OG000|Outcome|ncMCE Group|The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center [10]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
10782148|NCT04389333|OG001|Outcome|MCE Group|The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
10782149|NCT04389333|OG000|Outcome|ncMCE Group|The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
10782150|NCT04389333|EG000|Reported Event|ncMCE Group|The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
10782151|NCT04389333|EG001|Reported Event|MCE Group|The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
11193896|NCT02148809|BG000|Baseline|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
11193897|NCT02148809|FG000|Participant Flow|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
11193898|NCT02148809|OG000|Outcome|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
11193899|NCT02148809|OG000|Outcome|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
11193900|NCT02148809|EG000|Reported Event|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
11193901|NCT02148835|BG000|Baseline|Triomeg|"Sausage: Triomeg~Sausage: Triomeg: Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g."
11193902|NCT02148835|BG001|Baseline|Control Sausage|"Sausage: Control~Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester."
11193903|NCT02148835|BG002|Baseline|Total|Total of all reporting groups
11193904|NCT02148835|FG000|Participant Flow|Triomeg|"Sausage: Triomeg~Sausage: Triomeg: Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g."
10782152|NCT03712124|BG000|Baseline|CNSA-001|Participants received CNSA-001 20 mg/kg/day (10 mg/kg BID) as an oral suspension for 14 days.
10782153|NCT03712124|BG001|Baseline|Placebo|Participants received placebo matched to CNSA-001 BID for 14 days.
10782154|NCT03712124|BG002|Baseline|Total|Total of all reporting groups
10782155|NCT03712124|FG000|Participant Flow|CNSA-001|Participants received CNSA-001 (sepiapterin) 20 milligrams (mg)/kilogram (kg)/day (10 mg/kg twice daily [BID]) as an oral suspension for 14 days.
10782156|NCT03712124|FG001|Participant Flow|Placebo|Participants received placebo matched to CNSA-001 BID for 14 days.
10782157|NCT03712124|OG000|Outcome|CNSA-001|Participants received CNSA-001 20 mg/kg/day (10 mg/kg BID) as an oral suspension for 14 days.
10782158|NCT03712124|OG001|Outcome|Placebo|Participants received placebo matched to CNSA-001 BID for 14 days.
10782159|NCT03712124|EG000|Reported Event|CNSA-001|Participants received CNSA-001 20 mg/kg/day (10 mg/kg BID) as an oral suspension for 14 days.
10782160|NCT03712124|EG001|Reported Event|Placebo|Participants received placebo matched to CNSA-001 BID for 14 days.
10782161|NCT03689582|BG000|Baseline|68Ga-PSMA|PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
10782162|NCT03689582|FG000|Participant Flow|68Ga-PSMA|PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
10782163|NCT03689582|OG000|Outcome|Histology Result of Biopsy: Prostate Cancer|Participants whose histology result of biopsy is prostate cancer.
10782164|NCT03689582|OG001|Outcome|Benign Histology Result|Participants whose histology result of biopsy is benign.
10782165|NCT03689582|OG000|Outcome|68Ga-PSMA|PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
10782166|NCT03689582|EG000|Reported Event|68Ga-PSMA|PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
10801592|NCT03529773|FG034|Participant Flow|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801593|NCT03529773|FG035|Participant Flow|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801594|NCT03529773|FG036|Participant Flow|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
11380480|NCT01425008|BG019|Baseline|Total|Total of all reporting groups
10801595|NCT03529773|FG037|Participant Flow|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801596|NCT03529773|FG038|Participant Flow|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801597|NCT03529773|FG039|Participant Flow|Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801598|NCT03529773|OG000|Outcome|Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801599|NCT03529773|OG001|Outcome|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
11193905|NCT02148835|FG001|Participant Flow|Control Sausage|"Sausage: Control~Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester."
10782167|NCT03535740|BG000|Baseline|Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 20 months from start of enrollment until data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.
10782168|NCT03535740|FG000|Participant Flow|Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 20 months from start of enrollment until data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.
10782169|NCT03535740|OG000|Outcome|Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 20 months from start of enrollment until data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.
10782170|NCT03535740|EG000|Reported Event|Brigatinib 90 mg/180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity Up to approximately 20 months from start of enrollment till data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.
10782171|NCT03535740|EG001|Reported Event|Brigatinib 240 mg|Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option from start of enrollment to receive brigatinib 240 mg QD based on investigator's discretion up to data-cut off: 30 September 2020 (approximately 20 months). Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end.
10782172|NCT02986789|BG000|Baseline|Control Group|Clinicians will be performing blood transfusions using hospital standard of care procedures.
10782173|NCT02986789|BG001|Baseline|Evaluation Group|"Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.~In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)"
10782174|NCT02986789|BG002|Baseline|Total|Total of all reporting groups
10782175|NCT02986789|FG000|Participant Flow|Control Group|Clinicians will be performing blood transfusions using hospital standard of care procedures.
10782176|NCT02986789|FG001|Participant Flow|Evaluation Group|"Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.~In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)"
10782177|NCT02986789|OG000|Outcome|Control Group|Clinicians will be performing blood transfusions using hospital standard of care procedures.
10782178|NCT02986789|OG001|Outcome|Evaluation Group|"Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.~In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)"
10782179|NCT02986789|EG000|Reported Event|Control Group|Clinicians will be performing blood transfusions using hospital standard of care procedures.
10782180|NCT02986789|EG001|Reported Event|Evaluation Group|"Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.~In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)"
10782181|NCT02974907|BG000|Baseline|RGN-259|Active (0.1% RGN-259 ophthalmic solution)
10782182|NCT02974907|BG001|Baseline|Placebo|Placebo (Placebo ophthalmic solution)
10782183|NCT02974907|BG002|Baseline|Total|Total of all reporting groups
10782184|NCT02974907|FG000|Participant Flow|RGN-259|Active (0.1% RGN-259 ophthalmic solution)
10782185|NCT02974907|FG001|Participant Flow|Placebo|Placebo (Placebo ophthalmic solution)
10782186|NCT02974907|OG000|Outcome|RGN-259|Active (0.1% RGN-259 ophthalmic solution)
10782187|NCT02974907|OG001|Outcome|Placebo|Placebo (Placebo ophthalmic solution)
10782188|NCT02974907|EG000|Reported Event|RGN-259|Active (0.1% RGN-259 ophthalmic solution)
10782189|NCT02974907|EG001|Reported Event|Placebo|Placebo (Placebo ophthalmic solution)
11193906|NCT02148835|OG000|Outcome|Triomeg|"Sausage: Triomeg~Sausage: Triomeg: Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g."
10801600|NCT03529773|OG002|Outcome|Sentinel Cohort: RSV 120 mcg Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801601|NCT03529773|OG003|Outcome|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801602|NCT03529773|OG004|Outcome|Sentinel Cohort: RSV 240 mcg Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801603|NCT03529773|OG005|Outcome|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801604|NCT03529773|OG006|Outcome|Sentinel Cohort: Placebo Age 18-49 Years|Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination
10801605|NCT03529773|OG000|Outcome|Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801606|NCT03529773|OG001|Outcome|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801607|NCT03529773|OG002|Outcome|Sentinel Cohort: RSV 120 mcg Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801608|NCT03529773|OG003|Outcome|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801609|NCT03529773|OG004|Outcome|Sentinel Cohort: RSV 240 mcg Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801610|NCT03529773|OG005|Outcome|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801611|NCT03529773|OG006|Outcome|Sentinel Cohort: Placebo Age 50-85 Years|Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10801612|NCT03529773|OG000|Outcome|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801613|NCT03529773|OG001|Outcome|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801614|NCT03529773|OG002|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801615|NCT03529773|OG003|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801616|NCT03529773|OG004|Outcome|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801617|NCT03529773|OG005|Outcome|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801618|NCT03529773|OG006|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801619|NCT03529773|OG007|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801620|NCT03529773|OG008|Outcome|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10850910|NCT03999554|OG000|Outcome|Low Dose Sing2016 M2SR|"Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29~LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10850911|NCT03999554|OG001|Outcome|Medium Dose Sing2016 M2SR|"Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29~MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11193907|NCT02148835|OG001|Outcome|Control Sausage|"Sausage: Control~Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester."
10782199|NCT02918500|BG000|Baseline|Placebo|Participants will receive 3 weeks of inactive NRT patches.
10782200|NCT02918500|BG001|Baseline|Active|"Participants will receive 3 weeks of active NRT patches~Nicoderm Patch: Nicotine replacement therapy patch"
10782201|NCT02918500|BG002|Baseline|Total|Total of all reporting groups
10782202|NCT02918500|FG000|Participant Flow|Placebo|Participants will receive 3 weeks of inactive NRT patches.
10782203|NCT02918500|FG001|Participant Flow|Active|"Participants will receive 3 weeks of active NRT patches~Nicoderm Patch: Nicotine replacement therapy patch"
10782204|NCT02918500|OG000|Outcome|Placebo|Participants will receive 3 weeks of inactive NRT patches.
10782205|NCT02918500|OG001|Outcome|Active|"Participants will receive 3 weeks of active NRT patches~Nicoderm Patch: Nicotine replacement therapy patch"
10782206|NCT02918500|OG001|Outcome|Active|Participants will receive 3 weeks of active NRT patches
10782207|NCT02918500|EG000|Reported Event|Placebo|Participants will receive 3 weeks of inactive NRT patches.
10782208|NCT02918500|EG001|Reported Event|Active|"Participants will receive 3 weeks of active NRT patches~Nicoderm Patch: Nicotine replacement therapy patch"
10782209|NCT02896257|BG000|Baseline|Usual Care Patients|Standard practice (usual care). Primary care providers treat their patients as usual.
10782210|NCT02896257|BG001|Baseline|Intervention Patients|"Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.~Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care."
10782211|NCT02896257|BG002|Baseline|Usual Care Providers|Standard practice (usual care). Primary care providers treat their patients as usual.
11339888|NCT03640507|BG002|Baseline|Saline|"Subjects will receive vaginal preparation with sterile saline.~Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks."
10782212|NCT02896257|BG003|Baseline|Intervention Providers|"Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.~Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care."
10782213|NCT02896257|BG004|Baseline|Total|Total of all reporting groups
10782214|NCT02896257|FG000|Participant Flow|Usual Care|Primary care providers treat their patients as usual.
10782215|NCT02896257|FG001|Participant Flow|Intervention|Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
10782216|NCT02896257|OG000|Outcome|Usual Care|Primary care providers treat their patients as usual.
10782217|NCT02896257|OG001|Outcome|Intervention|Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
10782218|NCT02896257|OG000|Outcome|Intervention|Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
10782219|NCT02896257|EG000|Reported Event|Usual Care|Standard practice (usual care). Primary care providers treat their patients as usual.
10782220|NCT02896257|EG001|Reported Event|Intervention|"Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.~Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care."
10782221|NCT02774265|BG000|Baseline|VTE Prophylaxis With Enoxaparin 30mg BID|"The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.~VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782222|NCT02774265|BG001|Baseline|VTE Prophylaxis With Aspirin 81mg BID|"The group receiving VTE prophylaxis with ASA 81mg PO BID~VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782223|NCT02774265|BG002|Baseline|Total|Total of all reporting groups
10782224|NCT02774265|FG000|Participant Flow|VTE Prophylaxis With Enoxaparin 30mg BID|"The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.~VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782225|NCT02774265|FG001|Participant Flow|VTE Prophylaxis With Aspirin 81mg BID|"The group receiving VTE prophylaxis with ASA 81mg PO BID~VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10850912|NCT03999554|OG002|Outcome|High Dose Sing2016 M2SR|"High dose Sing2016 M2SR will be administered intranasally on days 1 and 29~HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10850913|NCT03999554|OG003|Outcome|Placebo|"Saline will be administered intranasally on days 1 and 29~Placebo: This group will receive saline placebo administered intranasally."
10850914|NCT03999554|EG000|Reported Event|Low Dose Sing2016 M2SR|"Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29~LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10850915|NCT03999554|EG001|Reported Event|Medium Dose Sing2016 M2SR|"Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29~MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11339889|NCT03640507|BG003|Baseline|Total|Total of all reporting groups
11339890|NCT03640507|FG000|Participant Flow|Chlorhexidine-alcohol|"Subjects will receive vaginal preparation with chlorhexidine-alcohol.~Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks."
11339891|NCT03640507|FG001|Participant Flow|Povidine-iodine|"Subjects will receive vaginal preparation with povidine-iodine.~Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks."
11339892|NCT03640507|FG002|Participant Flow|Saline|"Subjects will receive vaginal preparation with sterile saline.~Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks."
11339893|NCT03640507|OG000|Outcome|Chlorhexidine-alcohol|"Subjects will receive vaginal preparation with chlorhexidine-alcohol.~Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks."
11339894|NCT03640507|OG001|Outcome|Povidine-iodine|"Subjects will receive vaginal preparation with povidine-iodine.~Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks."
11339895|NCT03640507|OG002|Outcome|Saline|"Subjects will receive vaginal preparation with sterile saline.~Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks."
11339896|NCT03640507|EG000|Reported Event|Chlorhexidine-alcohol|"Subjects will receive vaginal preparation with chlorhexidine-alcohol.~Chlorhexidine-alcohol: Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks."
11339897|NCT03640507|EG001|Reported Event|Povidine-iodine|"Subjects will receive vaginal preparation with povidine-iodine.~Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks."
11339898|NCT03640507|EG002|Reported Event|Saline|"Subjects will receive vaginal preparation with sterile saline.~Sterile saline: Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks."
11339899|NCT03640559|BG000|Baseline|Placebo|"the group were having the administration of Placebo (saline 2.4 mL/kg IP)~Placebos"
11339900|NCT03640559|BG001|Baseline|Seroguard|"the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP~Seroguard"
11339901|NCT03640559|BG002|Baseline|Total|Total of all reporting groups
11339902|NCT03640559|FG000|Participant Flow|Placebo|"the group were having the administration of Placebo (saline 2.4 mL/kg IP)~Placebos"
11339903|NCT03640559|FG001|Participant Flow|Seroguard|"the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP~Seroguard"
11339904|NCT03640559|OG000|Outcome|Placebo|"the group were having the administration of Placebo (saline 2.4 mL/kg IP)~Placebos"
11339905|NCT03640559|OG001|Outcome|Seroguard|"the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP~Seroguard"
11339906|NCT03640559|EG000|Reported Event|Placebo|"the group were having the administration of Placebo (saline 2.4 mL/kg IP)~Placebos"
11339907|NCT03640559|EG001|Reported Event|Seroguard|"the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP~Seroguard"
11339908|NCT03640832|BG000|Baseline|Developmental Facial Serum (Test Product)|Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339909|NCT03640832|BG001|Baseline|Physiogel Calming Relief Anti-redness Serum(Reference Product)|Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339910|NCT03640832|BG002|Baseline|Total|Total of all reporting groups
11339911|NCT03640832|FG000|Participant Flow|Developmental Facial Serum (Test Product)|Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339912|NCT03640832|FG001|Participant Flow|Physiogel Calming Relief Anti-redness Serum(Reference Product)|Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339913|NCT03640832|OG000|Outcome|Developmental Facial Serum (Test Product)|Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339914|NCT03640832|OG001|Outcome|Physiogel Calming Relief Anti-redness Serum(Reference Product)|Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339915|NCT03640832|EG000|Reported Event|Developmental Facial Serum (Test Product)|Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339916|NCT03640832|EG001|Reported Event|Physiogel Calming Relief Anti-redness Serum(Reference Product)|Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
11339917|NCT03641508|BG000|Baseline|Triamcinolone|"The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine~Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine"
11339918|NCT03641508|BG001|Baseline|Dexamethasone|"The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine~Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine"
11339919|NCT03641508|BG002|Baseline|Total|Total of all reporting groups
11339920|NCT03641508|FG000|Participant Flow|Triamcinolone|"The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine~Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine"
10782226|NCT02774265|OG000|Outcome|VTE Prophylaxis With Enoxaparin 30mg BID|"The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.~VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782227|NCT02774265|OG001|Outcome|VTE Prophylaxis With Aspirin 81mg BID|"The group receiving VTE prophylaxis with ASA 81mg PO BID~VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782228|NCT02774265|EG000|Reported Event|VTE Prophylaxis With Enoxaparin 30mg BID|"The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.~VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782229|NCT02774265|EG001|Reported Event|VTE Prophylaxis With Aspirin 81mg BID|"The group receiving VTE prophylaxis with ASA 81mg PO BID~VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury."
10782230|NCT02736617|BG000|Baseline|Overall Study|Participants who receive at least one dose of either study drug.
10782231|NCT02736617|FG000|Participant Flow|Overall Study|Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
10782232|NCT02736617|OG000|Outcome|Efficacy Evaluable|Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
10782233|NCT02736617|OG000|Outcome|Overall Study|Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
10782234|NCT02736617|EG000|Reported Event|Overall Study|Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
11339921|NCT03641508|FG001|Participant Flow|Dexamethasone|"The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine~Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine"
10782235|NCT02652468|BG000|Baseline|Peripheral Blood Stem Cell Transplant|"PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.~TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1.~GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient)."
10782236|NCT02652468|FG000|Participant Flow|Peripheral Blood Stem Cell Transplant|"PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.~TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg participant body weight (BW), Participants may receive a second graft on day 1.~GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient)."
10782237|NCT02652468|OG000|Outcome|Peripheral Blood Stem Cell Transplant|"PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.~TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1.~GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient)."
10782238|NCT02652468|EG000|Reported Event|Peripheral Blood Stem Cell Transplant|"PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.~TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1.~GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient)."
10782239|NCT02579265|BG000|Baseline|Intralipid® 20%|"Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Intralipid® 20% will be infused into a central or peripheral vein."
10782240|NCT02579265|BG001|Baseline|Smoflipid 20%|"Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.~In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Smoflipid 20% will be infused into a central or a peripheral vein."
10782241|NCT02579265|BG002|Baseline|Total|Total of all reporting groups
10782242|NCT02579265|FG000|Participant Flow|Smoflipid 20%|"Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.~In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Smoflipid 20% will be infused into a central or a peripheral vein."
10782243|NCT02579265|FG001|Participant Flow|Intralipid® 20%|"Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Intralipid® 20% will be infused into a central or peripheral vein."
10782244|NCT02579265|OG000|Outcome|Intralipid® 20%|"Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Intralipid® 20% will be infused into a central or peripheral vein."
10782245|NCT02579265|OG001|Outcome|Smoflipid 20%|"Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.~In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Smoflipid 20% will be infused into a central or a peripheral vein."
10782246|NCT02579265|EG000|Reported Event|Intralipid® 20%|"Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Intralipid® 20% will be infused into a central or peripheral vein."
10782247|NCT02579265|EG001|Reported Event|Smoflipid 20%|"Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.~Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.~In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.~Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.~Smoflipid 20% will be infused into a central or a peripheral vein."
10782248|NCT02013167|BG000|Baseline|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
10782249|NCT02013167|BG001|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
10782250|NCT02013167|BG002|Baseline|Total|Total of all reporting groups
10782251|NCT02013167|FG000|Participant Flow|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
10782252|NCT02013167|FG001|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
10782253|NCT02013167|OG000|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
10782254|NCT02013167|OG001|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
10782255|NCT02013167|OG000|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
10782256|NCT02013167|EG000|Reported Event|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
10782257|NCT02013167|EG001|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.~The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
10782258|NCT02004522|BG000|Baseline|Duvelisib|Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules
10782259|NCT02004522|BG001|Baseline|Ofatumumab|Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL
10782260|NCT02004522|BG002|Baseline|Total|Total of all reporting groups
10782261|NCT02004522|FG000|Participant Flow|Duvelisib|Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules
10782262|NCT02004522|FG001|Participant Flow|Ofatumumab|"Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL~Ofatumumab"
10782263|NCT02004522|OG000|Outcome|Duvelisib|Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules
10782264|NCT02004522|OG001|Outcome|Ofatumumab|"Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL~Ofatumumab"
10782265|NCT02004522|EG000|Reported Event|Duvelisib|Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules
10782266|NCT02004522|EG001|Reported Event|Ofatumumab|"Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL~Ofatumumab"
10782267|NCT02000427|BG000|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
10782268|NCT02000427|FG000|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
10782269|NCT02000427|OG000|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
10782270|NCT02000427|EG000|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.~The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
10782271|NCT01981850|BG000|Baseline|Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)|Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782272|NCT01981850|BG001|Baseline|Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)|Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782273|NCT01981850|BG002|Baseline|Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782274|NCT01981850|BG003|Baseline|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782275|NCT01981850|BG004|Baseline|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782276|NCT01981850|BG005|Baseline|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782277|NCT01981850|BG006|Baseline|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782278|NCT01981850|BG007|Baseline|Total|Total of all reporting groups
10782279|NCT01981850|FG000|Participant Flow|Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)|Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782280|NCT01981850|FG001|Participant Flow|Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)|Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782281|NCT01981850|FG002|Participant Flow|Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782282|NCT01981850|FG003|Participant Flow|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782283|NCT01981850|FG004|Participant Flow|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782284|NCT01981850|FG005|Participant Flow|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782285|NCT01981850|FG006|Participant Flow|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782286|NCT01981850|FG007|Participant Flow|OLE Stage 1: RO7490677 10 mg/kg IV Q4W|Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
10782287|NCT01981850|FG008|Participant Flow|OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib|Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
10782288|NCT01981850|FG009|Participant Flow|OLE Stage 2: RO7490677 10 mg/kg IV Q4W|Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
10782289|NCT01981850|OG000|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)|Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782290|NCT01981850|OG001|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)|Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782291|NCT01981850|OG002|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782292|NCT01981850|OG003|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782293|NCT01981850|OG000|Outcome|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782294|NCT01981850|OG001|Outcome|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782295|NCT01981850|OG002|Outcome|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782296|NCT01981850|OG000|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV QW; OLE: RO7490677 10 mg/kg IV Q4W|"Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.~Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."
10782297|NCT01981850|OG001|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W|"Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.~Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."
10782298|NCT01981850|OG002|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.|"Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.~Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."
10782299|NCT01981850|OG003|Outcome|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.|"Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.~Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."
10782300|NCT01981850|OG000|Outcome|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W|"Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.~Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE)."
10782301|NCT01981850|OG001|Outcome|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W|"Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.~Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE)."
10782302|NCT01981850|OG002|Outcome|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W|"Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.~Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE)."
10782303|NCT01981850|OG004|Outcome|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782304|NCT01981850|OG005|Outcome|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782305|NCT01981850|OG006|Outcome|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782306|NCT01981850|OG007|Outcome|OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)|Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782307|NCT01981850|OG008|Outcome|OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782308|NCT01981850|OG009|Outcome|OLE Stage 2: RO7490677 10 mg/kg IV Q4W|Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
10782309|NCT01981850|EG000|Reported Event|Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)|Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782310|NCT01981850|EG001|Reported Event|Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)|Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782311|NCT01981850|EG002|Reported Event|Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.
10782312|NCT01981850|EG003|Reported Event|Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib|Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
10782313|NCT01981850|EG004|Reported Event|Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
11339922|NCT03641508|OG000|Outcome|Triamcinolone|"The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine~Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine"
10782314|NCT01981850|EG005|Reported Event|Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782315|NCT01981850|EG006|Reported Event|Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W|Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.
10782316|NCT01981850|EG007|Reported Event|OLE Stage 1: RO7490677 10 mg/kg IV Q4W|Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
10782317|NCT01981850|EG008|Reported Event|OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib|Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.
10782318|NCT01981850|EG009|Reported Event|OLE Stage 2: RO7490677 10 mg/kg IV Q4W|Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
10782319|NCT01804816|BG000|Baseline|No Acupuncture/Acupuncture|No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles.
10782320|NCT01804816|FG000|Participant Flow|No Acupuncture / Acupuncture|5 weeks of no treatment followed by 5 weeks of standardized verum acupuncture.
10964564|NCT00878189|OG001|Outcome|PF-03084014 220 mg BID in Solid Tumor Participants|PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10782321|NCT01804816|OG000|Outcome|Baseline|Measurements at baseline visit.
10782322|NCT01804816|OG001|Outcome|Pre-Acupuncture|Measurements were taken after 5 full weeks of no treatment. This visit occurred 6-7 weeks after the baseline measurements.
10782323|NCT01804816|OG002|Outcome|Post-Acupuncture|Measurements were taken after 10 sessions of standardized verum acupuncture administration using 0.18-0.25×30-60-mm stainless steel needles. Acupuncture sessions were scheduled twice a week for 5 weeks. This post-acupuncture visit occurred within 1 week of finishing the acupuncture sessions.
10782324|NCT01804816|OG000|Outcome|Baseline|Measurements at baseline visit
10782325|NCT01804816|EG000|Reported Event|No Acupuncture/Acupuncture|No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles.
10801621|NCT03529773|OG009|Outcome|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801622|NCT03529773|OG010|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801623|NCT03529773|OG011|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801624|NCT03529773|OG012|Outcome|Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801625|NCT03529773|OG000|Outcome|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10964565|NCT00878189|OG001|Outcome|PF-03084014 80 mg BID in Solid Tumor Participants|PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10801626|NCT03529773|OG001|Outcome|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10782326|NCT01572207|BG000|Baseline|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
10782327|NCT01572207|BG001|Baseline|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
10782328|NCT01572207|BG002|Baseline|Total|Total of all reporting groups
10782329|NCT01572207|FG000|Participant Flow|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
10782330|NCT01572207|FG001|Participant Flow|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
10782331|NCT01572207|OG000|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
10782332|NCT01572207|OG001|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
10782333|NCT01572207|EG000|Reported Event|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
10964566|NCT00878189|OG002|Outcome|PF-03084014 150 mg BID in Solid Tumor Participants|PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10782334|NCT01572207|EG001|Reported Event|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
10782335|NCT01550315|BG000|Baseline|All Study POTS|"POTS patients received high sodium diet for 4-5 days prior to study day. Then received either a high sodium diet (300 mEq/day) diet for 6 days, then after 2 weeks were randomized in a crossover design to receive a low sodium diet (10 mEq/day) diet for 6 days, or viceversa (first low then high salt diet). All POTS patients received both diets.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782336|NCT01550315|BG001|Baseline|All Study Controls|"Healthy controls received high sodium diet for 4-5 days prior to study day. Then received either a high sodium diet (300 mEq/day) diet for 6 days, then after 2 weeks were randomized in a crossover design to receive a low sodium diet (10 mEq/day) diet for 6 days, or viceversa (first low then high salt diet). All healthy controls received both diets.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782337|NCT01550315|BG002|Baseline|Total|Total of all reporting groups
10782338|NCT01550315|FG000|Participant Flow|High Sodium First- POTS|POTS patients received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design and two weeks after, were crossover to receive a low high diet for 6 days
10782339|NCT01550315|FG001|Participant Flow|Low Sodium Diet First-POTS|POTS patients received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design, and two weeks later received a high salt diet.
10782340|NCT01550315|FG002|Participant Flow|High Sodium First- Controls|Healthy Controls received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design and two weeks after, received a low high diet for 6 days
10782341|NCT01550315|FG003|Participant Flow|Low Sodium First-Controls|Healthy Controls received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design, and two weeks later received a high salt diet.
10964567|NCT00878189|OG003|Outcome|PF-03084014 220 mg BID in Solid Tumor Participants|PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10782342|NCT01550315|OG000|Outcome|High Sodium POTS|"POTS patients received a high sodium diet for 4-5 days prior to study day. After enrollment, they received a high salt diet (300 mEq/day) diet for 6 days in a randomized crossover design.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782343|NCT01550315|OG001|Outcome|Low Sodium Diet POTS|"POTS patients received a high sodium diet for 4-5 days prior to study day. After enrollment, they received either a low-sodium (LS; 10 mEq/day) diet for 6 days.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782344|NCT01550315|OG002|Outcome|High Sodium Controls|"Healthy controls received a high sodium diet for 4-5 days prior to study day. After enrollment, they received a high salt diet (300 mEq/day) diet for 6 days in a randomized crossover design.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782345|NCT01550315|OG003|Outcome|Low Sodium Controls|"Healthy controls received a high sodium diet for 4-5 days prior to study day. After enrollment, they received either a low-sodium (LS; 10 mEq/day) diet for 6 days.~Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities."
10782346|NCT01550315|EG000|Reported Event|High Sodium - POTS|POTS patients received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design
10782347|NCT01550315|EG001|Reported Event|Low Sodium Diet - POTS|POTS patients received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design
10782348|NCT01550315|EG002|Reported Event|High Sodium - Controls|Healthy controls received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design
10782349|NCT01550315|EG003|Reported Event|Low Sodium - Controls|Healthy controls received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design
10782350|NCT01519960|BG000|Baseline|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782351|NCT01519960|BG001|Baseline|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
10782352|NCT01519960|BG002|Baseline|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782353|NCT01519960|BG003|Baseline|Total|Total of all reporting groups
10782354|NCT01519960|FG000|Participant Flow|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m^2), 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg.
10850625|NCT00303667|BG000|Baseline|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
10850626|NCT00303667|BG001|Baseline|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
10850627|NCT00303667|BG002|Baseline|Total|Total of all reporting groups
10850916|NCT03999554|EG002|Reported Event|High Dose Sing2016 M2SR|"High dose Sing2016 M2SR will be administered intranasally on days 1 and 29~HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally."
10782355|NCT01519960|FG001|Participant Flow|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
10782356|NCT01519960|FG002|Participant Flow|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782357|NCT01519960|OG000|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782358|NCT01519960|OG001|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
10782359|NCT01519960|OG000|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782360|NCT01519960|OG002|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782361|NCT01519960|OG000|Outcome|All Groups Combined|Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10964568|NCT00878189|OG004|Outcome|PF-03084014 330 mg BID in Solid Tumor Participants|PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
11193908|NCT02148835|EG000|Reported Event|Triomeg|"Sausage: Triomeg~Sausage: Triomeg: Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g."
10782362|NCT01519960|EG000|Reported Event|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10782363|NCT01519960|EG001|Reported Event|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.
10782364|NCT01519960|EG002|Reported Event|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
10801627|NCT03529773|OG002|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
11193909|NCT02148835|EG001|Reported Event|Control Sausage|"Sausage: Control~Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester."
10782365|NCT01519960|EG003|Reported Event|Group D: Switch to PEG-IFN Monotherapy|Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m^2, 45 mcg; 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.
10782366|NCT00688376|BG000|Baseline|Donepezil|Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
10782367|NCT00688376|BG001|Baseline|Placebo|Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
10782368|NCT00688376|BG002|Baseline|Total|Total of all reporting groups
10966596|NCT00887653|OG000|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
11193910|NCT02148874|BG000|Baseline|Non-Obese|Pregnant women with a pre-pregnancy BMI 18.5-29.9.
11193911|NCT02148874|BG001|Baseline|Obese|Pregnant women with a pre-pregnancy BMI 30.0-50.0
11193912|NCT02148874|BG002|Baseline|Total|Total of all reporting groups
11193913|NCT02148874|FG000|Participant Flow|Non-Obese|Pregnant women with a pre-pregnancy BMI 18.5-29.9.
11193914|NCT02148874|FG001|Participant Flow|Obese|Pregnant women with a pre-pregnancy BMI 30.0-50.0
11193915|NCT02148874|OG000|Outcome|Non-Obese|Pregnant women with a pre-pregnancy BMI 18.5-29.9.
11193916|NCT02148874|OG001|Outcome|Obese|Pregnant women with a pre-pregnancy BMI 30.0-50.0
11193917|NCT02148874|EG000|Reported Event|Non-Obese|Pregnant women with a pre-pregnancy BMI 18.5-29.9.
11193918|NCT02148874|EG001|Reported Event|Obese|Pregnant women with a pre-pregnancy BMI 30.0-50.0.
11193919|NCT02148952|BG000|Baseline|Intervention Health Facility Participants|"Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
10782369|NCT00688376|FG000|Participant Flow|Donepezil|Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
10782370|NCT00688376|FG001|Participant Flow|Placebo|Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
10782371|NCT00688376|OG000|Outcome|Donepezil|Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
10782372|NCT00688376|OG001|Outcome|Placebo|Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
10782373|NCT00688376|EG000|Reported Event|Donepezil Double-Blind Phase|Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
10782374|NCT00688376|EG001|Reported Event|Placebo Double-Blind Phase|Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
10782375|NCT00688376|EG002|Reported Event|Donepezil Blinded Extension Phase|Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
11193920|NCT02148952|BG001|Baseline|Control Health Facility Participants|"Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Matched control facilities provided comparison for intervention facilities."
11193921|NCT02148952|BG002|Baseline|Total|Total of all reporting groups
10782376|NCT00688376|EG003|Reported Event|Placebo Blinded Extension Phase|Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
10782377|NCT00604201|BG000|Baseline|Co-infusion of UCB and Haploidentical CD34+ Cells|Stem cell recipients received co-infusion of unrelated umbilical cord blood (UCB) and haploidentical CD34+ cells from a related donor following non-myeloablative conditioning for neutropenic patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with refractory anemia (RA)
10782378|NCT00604201|FG000|Participant Flow|Co-infusion of UCB and Haploidentical CD34+ Cells|Stem cell recipients received co-infusion of unrelated umbilical cord blood (UCB) and haploidentical CD34+ cells from a related donor following non-myeloablative conditioning for neutropenic patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with refractory anemia (RA)
10782379|NCT00604201|OG000|Outcome|Co-infusion of UCB and Haploidentical CD34+ Cells|Stem cell recipients received co-infusion of unrelated umbilical cord blood (UCB) and haploidentical CD34+ cells from a related donor following non-myeloablative conditioning for neutropenic patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with refractory anemia (RA)
10782380|NCT00604201|EG000|Reported Event|Co-infusion of UCB and Haploidentical CD34+ Cells|Stem cell recipients received co-infusion of unrelated umbilical cord blood (UCB) and haploidentical CD34+ cells from a related donor following non-myeloablative conditioning for neutropenic patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with refractory anemia (RA)
10782381|NCT00492349|BG000|Baseline|Varenicline|
10782382|NCT00492349|BG001|Baseline|Placebo|
10782383|NCT00492349|BG002|Baseline|Total|Total of all reporting groups
11338863|NCT03618628|FG000|Participant Flow|People Using a CFO|"People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.~Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO."
10782384|NCT00492349|FG000|Participant Flow|Varenicline|Varenicline Treatment Group
10782385|NCT00492349|FG001|Participant Flow|Placebo|Placebo Control Group
10782386|NCT00492349|OG000|Outcome|Varenicline|Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
10782387|NCT00492349|OG001|Outcome|Placebo|Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
10782388|NCT00492349|OG000|Outcome|Varenicline|"Varenicline~Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks"
10782389|NCT00492349|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks"
10782390|NCT00492349|OG000|Outcome|Varenicline|Varenicline
10782391|NCT00492349|OG001|Outcome|Placebo|Placebo
10782392|NCT00492349|EG000|Reported Event|Varenicline|Varenicline
10782393|NCT00492349|EG001|Reported Event|Placebo|Placebo
10782394|NCT00121108|BG000|Baseline|Placebo|Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
10782395|NCT00121108|BG001|Baseline|Motavizumab|Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
10782396|NCT00121108|BG002|Baseline|Total|Total of all reporting groups
10782397|NCT00121108|FG000|Participant Flow|Placebo|Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
10782398|NCT00121108|FG001|Participant Flow|Motavizumab|Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
10782399|NCT00121108|OG000|Outcome|Placebo|Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
10782400|NCT00121108|OG001|Outcome|Motavizumab|Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
10782401|NCT00121108|OG000|Outcome|Motavizumab|Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
10782402|NCT00121108|EG000|Reported Event|PLACEBO|Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season.
10782403|NCT00121108|EG001|Reported Event|MOTAVIZUMAB|Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
10782404|NCT00003102|BG000|Baseline|Cohort 1 50cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iiodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782405|NCT00003102|BG001|Baseline|Cohort 2 75cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782406|NCT00003102|BG002|Baseline|Cohort 3 100cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782407|NCT00003102|BG003|Baseline|Total|Total of all reporting groups
10801628|NCT03529773|OG003|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10801629|NCT03529773|OG004|Outcome|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10964569|NCT00878189|EG000|Reported Event|PF-03084014 20 mg BID in Solid Tumor Participants|PF-03084014 20 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10966597|NCT00887653|EG000|Reported Event|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
11380481|NCT01425008|FG000|Participant Flow|Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)|TAK-580 20 milligram (mg), tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380482|NCT01425008|FG001|Participant Flow|Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)|TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380483|NCT01425008|FG002|Participant Flow|Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)|TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380484|NCT01425008|FG003|Participant Flow|Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)|TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380485|NCT01425008|FG004|Participant Flow|Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380486|NCT01425008|FG005|Participant Flow|Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)|TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380487|NCT01425008|FG006|Participant Flow|Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380488|NCT01425008|FG007|Participant Flow|QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)|TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380489|NCT01425008|FG008|Participant Flow|QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380490|NCT01425008|FG009|Participant Flow|QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)|TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380491|NCT01425008|FG010|Participant Flow|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with rapidly accelerated fibrosarcoma (RAF) and mitogen-activated protein kinase (MEPK kinase) or extracellular signal-regulated kinase (ERK kinase) (MEK) inhibitors.
11380492|NCT01425008|FG011|Participant Flow|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380493|NCT01425008|FG012|Participant Flow|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380494|NCT01425008|FG013|Participant Flow|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380495|NCT01425008|FG014|Participant Flow|Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (wild type [WT]), naive to any prior anticancer therapy except ipilimumab, anti-programmed cell death-1 (PD-1), and anti-PD ligand-1 (PDL-1) monoclonal antibodies.
11380496|NCT01425008|FG015|Participant Flow|Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
11380497|NCT01425008|FG016|Participant Flow|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
10964570|NCT00878189|EG001|Reported Event|PF-03084014 40 mg BID in Solid Tumor Participants|PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
11380498|NCT01425008|FG017|Participant Flow|Q2D Dose Expansion Phase: TAK-580 (BRAF+)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
11380499|NCT01425008|FG018|Participant Flow|QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380500|NCT01425008|OG000|Outcome|Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)|TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380501|NCT01425008|OG001|Outcome|Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)|TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380502|NCT01425008|OG002|Outcome|Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)|TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380503|NCT01425008|OG003|Outcome|Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)|TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380504|NCT01425008|OG004|Outcome|Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380505|NCT01425008|OG005|Outcome|Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)|TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380506|NCT01425008|OG006|Outcome|Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380507|NCT01425008|OG007|Outcome|QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)|TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380508|NCT01425008|OG008|Outcome|QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380509|NCT01425008|OG009|Outcome|QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)|TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380510|NCT01425008|OG010|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380511|NCT01425008|OG011|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380512|NCT01425008|OG012|Outcome|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380513|NCT01425008|OG013|Outcome|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380514|NCT01425008|OG014|Outcome|Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
11380515|NCT01425008|OG015|Outcome|Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
11380516|NCT01425008|OG016|Outcome|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
10801630|NCT03529773|OG005|Outcome|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
11339923|NCT03641508|OG001|Outcome|Dexamethasone|"The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine~Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine"
10966598|NCT00887679|BG000|Baseline|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
11339924|NCT03641508|EG000|Reported Event|Triamcinolone|"The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine~Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine"
11339925|NCT03641508|EG001|Reported Event|Dexamethasone|"The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine~Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine"
11339926|NCT03641716|BG000|Baseline|Mealtime PREP Intervention|"Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.~Mealtime PREP Intervention: Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines."
11339927|NCT03641716|FG000|Participant Flow|Mealtime PREP Intervention|"Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP (Promoting Routines of Exploration and Play) intervention to the family.~Mealtime PREP Intervention: Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines."
11339928|NCT03641716|OG000|Outcome|Mealtime PREP Intervention|"Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.~Mealtime PREP Intervention: Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines."
11339929|NCT03641716|EG000|Reported Event|Mealtime PREP Intervention|"Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.~Mealtime PREP Intervention: Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines."
11339930|NCT03642262|BG000|Baseline|Overall Study|"Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.~Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.~Cohort 1~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug administrations.~Cohort 2~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug administrations."
11339931|NCT03642262|FG000|Participant Flow|Cohort 1 (Mucinex First Then Guaifenesin)|"Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.~Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.~Cohort 1~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug administrations."
11339932|NCT03642262|FG001|Participant Flow|Cohort 2 (Guaifenesin Then Mucinex)|"Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.~Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.~Cohort 2~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug administrations."
11339933|NCT03642262|OG000|Outcome|Test: RB Mucinex® ER 600 mg|Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
11339934|NCT03642262|OG001|Outcome|Reference: Guaifenesin 200 mg|Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
11339935|NCT03642262|OG000|Outcome|All Study Participants|"Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.~Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition."
11339936|NCT03642262|EG000|Reported Event|Treatment A: Mucinex® ER 600 mg|Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
11339937|NCT03642262|EG001|Reported Event|Treatment B: Guaifenesin 200 mg|Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
11339938|NCT03642457|BG000|Baseline|Serratus Plane Group|Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
11339939|NCT03642457|BG001|Baseline|Placebo Group|Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
11339940|NCT03642457|BG002|Baseline|Total|Total of all reporting groups
11339941|NCT03642457|FG000|Participant Flow|Serratus Plane Group|Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
11339942|NCT03642457|FG001|Participant Flow|Placebo Group|Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
11380517|NCT01425008|OG017|Outcome|QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380518|NCT01425008|OG018|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
11380519|NCT01425008|OG010|Outcome|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
11380520|NCT01425008|OG007|Outcome|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
11380521|NCT01425008|OG000|Outcome|QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)|TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380522|NCT01425008|OG001|Outcome|QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380523|NCT01425008|OG002|Outcome|QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)|TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380524|NCT01425008|OG000|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380525|NCT01425008|OG001|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380526|NCT01425008|OG002|Outcome|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380527|NCT01425008|OG003|Outcome|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380528|NCT01425008|OG004|Outcome|Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (wild type [WT]), naive to any prior anticancer therapy except ipilimumab, anti-programmed cell death-1 (PD-1), and anti-PD ligand-1 (PDL-1) monoclonal antibodies.
11380529|NCT01425008|OG005|Outcome|Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
11380530|NCT01425008|OG006|Outcome|QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380531|NCT01425008|OG007|Outcome|Q2D Dose Expansion Phase: TAK-580 (BRAF+)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
11380532|NCT01425008|EG000|Reported Event|Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)|TAK-580 20 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cy cle 38).
11380533|NCT01425008|EG001|Reported Event|Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)|TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380534|NCT01425008|EG002|Reported Event|Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)|TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380535|NCT01425008|EG003|Reported Event|Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)|TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11338864|NCT03618628|OG000|Outcome|People Using a CFO|"People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.~Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO."
11338865|NCT03618628|EG000|Reported Event|People Using a CFO|"People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.~Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO."
10801631|NCT03529773|OG006|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
11338866|NCT03618823|BG000|Baseline|Opioid Pain Control|"Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.~Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338867|NCT03618823|BG001|Baseline|Non-opioid Pain Control|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338868|NCT03618823|BG002|Baseline|Total|Total of all reporting groups
11338869|NCT03618823|FG000|Participant Flow|Opioid Pain Control|"Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.~Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338870|NCT03618823|FG001|Participant Flow|Non-opioid Pain Control|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11339943|NCT03642457|OG000|Outcome|Serratus Plane Group|Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
11339944|NCT03642457|OG001|Outcome|Placebo Group|Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
11380536|NCT01425008|EG004|Reported Event|Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380537|NCT01425008|EG005|Reported Event|Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)|TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
10964571|NCT00878189|EG002|Reported Event|PF-03084014 80 mg BID in Solid Tumor Participants|PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964572|NCT00878189|EG003|Reported Event|PF-03084014 100 mg BID in Solid Tumor Participants|PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10966599|NCT00887679|FG000|Participant Flow|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
11380538|NCT01425008|EG006|Reported Event|Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380539|NCT01425008|EG007|Reported Event|QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)|TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380540|NCT01425008|EG008|Reported Event|QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
10782408|NCT00003102|FG000|Participant Flow|Cohort 1 50cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
11380541|NCT01425008|EG009|Reported Event|QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)|TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
11380542|NCT01425008|EG010|Reported Event|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380543|NCT01425008|EG011|Reported Event|Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380544|NCT01425008|EG012|Reported Event|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11380545|NCT01425008|EG013|Reported Event|Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
11380546|NCT01425008|EG014|Reported Event|Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
11380547|NCT01425008|EG015|Reported Event|Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
11380548|NCT01425008|EG016|Reported Event|Q2D Dose Expansion Phase: Pharmacokinetic Cohort|TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
10782409|NCT00003102|FG001|Participant Flow|Cohort 2 75cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782410|NCT00003102|FG002|Participant Flow|Cohort 3 100cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782411|NCT00003102|OG000|Outcome|Cohort 1 50cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782412|NCT00003102|OG001|Outcome|Cohort 2 75cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782413|NCT00003102|OG002|Outcome|Cohort 3 100cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782414|NCT00003102|EG000|Reported Event|Cohort 1 50cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10801632|NCT03529773|OG007|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
10850917|NCT03999554|EG003|Reported Event|Low Dose Bris10 M2SR|"Low dose Bris10 M2SR will be administered intranasally on days 1 and 29~LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally."
11339945|NCT03642457|EG000|Reported Event|Serratus Plane Group|Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
10850918|NCT03999554|EG004|Reported Event|Placebo|"Saline will be administered intranasally on days 1 and 29~Placebo: This group will receive saline placebo administered intranasally."
10782415|NCT00003102|EG001|Reported Event|Cohort 2 75cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10782416|NCT00003102|EG002|Reported Event|Cohort 3 100cGy Radiation|"On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes.~Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 mCi/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131.~In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.~Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250): cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use."
10801633|NCT03529773|OG008|Outcome|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801634|NCT03529773|OG009|Outcome|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801635|NCT03529773|OG010|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801636|NCT03529773|OG011|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801637|NCT03529773|OG012|Outcome|Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801638|NCT03529773|OG006|Outcome|Sentinel Cohort: Placebo Age 18-49 Years|Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10964573|NCT00878189|EG004|Reported Event|PF-03084014 130 mg BID in Solid Tumor Participants|PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10801639|NCT03529773|OG001|Outcome|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801640|NCT03529773|OG002|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801641|NCT03529773|OG003|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10782417|NCT04633837|BG000|Baseline|Group 1 Control|Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
10782418|NCT04633837|BG001|Baseline|Group 2: ECM Injectable Graft|"Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery~Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study."
10782419|NCT04633837|BG002|Baseline|Total|Total of all reporting groups
10782420|NCT04633837|FG000|Participant Flow|Group 1 Control|Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
10782421|NCT04633837|FG001|Participant Flow|Group 2: ECM Injectable Graft|"Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery~Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study."
10782422|NCT04633837|OG000|Outcome|Group 1 Control|Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
10782423|NCT04633837|OG001|Outcome|Group 2: ECM Injectable Graft|"Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery~Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study."
10782424|NCT04633837|EG000|Reported Event|Group 1 Control|Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.
10782425|NCT04633837|EG001|Reported Event|Group 2: ECM Injectable Graft|"Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery~Extracellular Matrix Graft Injectable Implant: The extracellular matrix injectable implant will serve as the intervention in this study."
10801642|NCT03529773|OG005|Outcome|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801643|NCT03529773|OG006|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801644|NCT03529773|OG007|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801645|NCT03529773|OG008|Outcome|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801646|NCT03529773|OG009|Outcome|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801647|NCT03529773|OG010|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801648|NCT03529773|OG011|Outcome|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801649|NCT03529773|OG001|Outcome|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801650|NCT03529773|OG002|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11339946|NCT03642457|EG001|Reported Event|Placebo Group|Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
10782426|NCT04057937|BG000|Baseline|Placebo Then Apremilast 30mg BID|Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32).
10782427|NCT04057937|BG001|Baseline|Apremilast 30 mg BID Then Apremilast 30 mg BID|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32).
10782428|NCT04057937|BG002|Baseline|Total|Total of all reporting groups
10782429|NCT04057937|FG000|Participant Flow|Placebo Then Apremilast 30mg BID|Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32).
10782430|NCT04057937|FG001|Participant Flow|Apremilast 30 mg BID Then Apremilast 30 mg BID|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32).
10782431|NCT04057937|OG000|Outcome|Placebo-controlled Phase - Placebo|Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
10782432|NCT04057937|OG001|Outcome|Placebo-controlled Phase - Apremilast 30 mg BID|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
10782433|NCT04057937|EG000|Reported Event|Placebo-controlled Phase - Placebo|Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
10782434|NCT04057937|EG001|Reported Event|Placebo-controlled Phase - Apremilast 30 mg BID|Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
10782435|NCT04057937|EG002|Reported Event|Active-treatment Phase - Apremilast 30 mg BID|All participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32).
10782436|NCT03566732|BG000|Baseline|Bereaved Relatives|Bereaved relatives after cancer deaths in hospitals
10782437|NCT03566732|FG000|Participant Flow|Bereaved Relatives|Bereaved relatives after cancer deaths in hospitals
10782438|NCT03566732|OG000|Outcome|Bereaved Relatives|Bereaved relatives after cancer deaths in hospitals
10782439|NCT03566732|EG000|Reported Event|Bereaved Relatives|Bereaved relatives after cancer deaths in hospitals
10782440|NCT03032510|BG000|Baseline|Eravacycline (Intravenous)/Levofloxacin (Oral)|"Eravacycline 1.5 mg/kg IV q24h~Placebo IV~Levofloxacin PO"
10782441|NCT03032510|BG001|Baseline|Ertapenem (Intravenous)/Levofloxacin (Oral)|"Ertapenem 1.0g IV q24h~Placebo IV~Levofloxacin PO"
10782442|NCT03032510|BG002|Baseline|Total|Total of all reporting groups
10782443|NCT03032510|FG000|Participant Flow|Eravacycline (Intravenous)/Levofloxacin (Oral)|"Eravacycline 1.5mg/kg IV q24h~Placebo IV q24h~Levofloxacin (PO)"
10782444|NCT03032510|FG001|Participant Flow|Ertapenem (Intravenous)/Levofloxacin (Oral)|"Ertapenem 1g IV q24h~Placebo IV q24h~Levofloxacin (PO)"
10782445|NCT03032510|OG000|Outcome|Eravacycline (Intravenous)|Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 5 doses were administered IV. An IV-to-PO transition could occur after dose 5. During PO administration, subjects received 750 mg of levofloxacin once daily. Total treatment duration was 7 or 10 days.
10782446|NCT03032510|OG001|Outcome|Ertapenem (Intravenous)|Ertapenem was administered IV at a dose of 1 g q24h. At minimum, the first 5 doses were administered IV. An IV-to-PO transition could occur after dose 5. During PO administration, subjects received 750 mg of levofloxacin once daily. Total treatment duration was 7 or 10 days.
10782447|NCT03032510|OG000|Outcome|Eravacycline|micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity.
10782448|NCT03032510|OG001|Outcome|Ertapenem|micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity.
10782449|NCT03032510|OG000|Outcome|Eravacycline (Intravenous)/Levofloxacin (Oral)|ITT included all randomized participants, regardless of receiving study drug or not.
10782450|NCT03032510|OG001|Outcome|Ertapenem (Intravenous)/Levofloxacin (Oral)|ITT included all randomized participants, regardless of receiving study drug or not.
10782451|NCT03032510|EG000|Reported Event|Eravacycline (Intravenous)|Eravacycline 1.5 mg/kg IV -The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject randomized to the ertapenem group received a dose of eravacycline and was included in the eravacycline group in the safety analysis.
10782452|NCT03032510|EG001|Reported Event|Ertapenem (Intravenous)|Ertapenem 1 g IV-The safety population was all randomized subjects who receive any amount of study drug. All safety analyses were conducted in this population and are presented by treatment actually received (not as randomized). One subject randomized to the ertapenem group received a dose of eravacycline and was included in the eravacycline group in the safety analysis.
10782453|NCT03029000|BG000|Baseline|Tbo-Filgrastim (GRANIX)|Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
10782454|NCT03029000|FG000|Participant Flow|Tbo-Filgrastim (GRANIX)|Participant received tbo-filgrastim 10 micrograms per kilogram (mcg/kg) of body weight, administered subcutaneously on the morning of Days 1 to 5.
10782455|NCT03029000|OG000|Outcome|Tbo-Filgrastim (GRANIX)|Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
10782456|NCT03029000|EG000|Reported Event|Tbo-Filgrastim (GRANIX)|Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
10782457|NCT03022292|BG000|Baseline|IAI Treatment|"Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.~Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC~optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI."
10782458|NCT03022292|FG000|Participant Flow|IAI Treatment|"Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.~Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC~optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI."
10782459|NCT03022292|OG000|Outcome|IAI Treatment|"Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.~Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC~optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI."
10782460|NCT03022292|EG000|Reported Event|IAI Treatment|"Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.~Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC~optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI."
10782461|NCT02968602|BG000|Baseline|Minocycline|"Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.~Minocycline: Minocycline capsules taken twice daily for two weeks."
10782462|NCT02968602|BG001|Baseline|Placebo|"Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.~Placebo: Placebo capsules taken twice daily for two weeks."
10782463|NCT02968602|BG002|Baseline|Total|Total of all reporting groups
10782464|NCT02968602|FG000|Participant Flow|Minocycline|"Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.~Minocycline: Minocycline capsules taken twice daily for two weeks."
10782465|NCT02968602|FG001|Participant Flow|Placebo|"Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.~Placebo: Placebo capsules taken twice daily for two weeks."
10782466|NCT02968602|OG000|Outcome|Minocycline|"Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.~Minocycline: Minocycline capsules taken twice daily for two weeks."
10782467|NCT02968602|OG001|Outcome|Placebo|"Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.~Placebo: Placebo capsules taken twice daily for two weeks."
10782468|NCT02968602|EG000|Reported Event|Minocycline|"Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.~Minocycline: Minocycline capsules taken twice daily for two weeks."
10782469|NCT02968602|EG001|Reported Event|Placebo|"Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.~Placebo: Placebo capsules taken twice daily for two weeks."
10782470|NCT02946047|BG000|Baseline|Ixazomib 1 mg|"Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782471|NCT02946047|BG001|Baseline|Ixazomib 2 mg|"Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782472|NCT02946047|BG002|Baseline|Ixazomib 3 mg|"Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782473|NCT02946047|BG003|Baseline|Ixazomib 4 mg|"Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782474|NCT02946047|BG004|Baseline|Total|Total of all reporting groups
10782475|NCT02946047|FG000|Participant Flow|Ixazomib 1 mg|"Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782476|NCT02946047|FG001|Participant Flow|Ixazomib 2 mg|"Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
11339960|NCT03642873|OG001|Outcome|Treatment C (Test) - Plasma Guaifenesin|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
11339961|NCT03642873|OG002|Outcome|Treatments B (Reference) - Plasma Hydrocodone Bitartrate|Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
10782477|NCT02946047|FG002|Participant Flow|Ixazomib 3 mg|"Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782478|NCT02946047|FG003|Participant Flow|Ixazomib 4 mg|"Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782479|NCT02946047|OG000|Outcome|Ixazomib 1 mg|"Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782480|NCT02946047|OG001|Outcome|Ixazomib 2 mg|"Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782481|NCT02946047|OG002|Outcome|Ixazomib 3 mg|"Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782482|NCT02946047|OG003|Outcome|Ixazomib 4 mg|"Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782483|NCT02946047|EG000|Reported Event|Ixazomib 1 mg|"Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782484|NCT02946047|EG001|Reported Event|Ixazomib 2 mg|"Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782485|NCT02946047|EG002|Reported Event|Ixazomib 3 mg|"Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782486|NCT02946047|EG003|Reported Event|Ixazomib 4 mg|"Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.~Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days."
10782487|NCT02830165|BG000|Baseline|Stereotactic Body Radiation Therapy (SBRT)|Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
10782488|NCT02830165|FG000|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
10782489|NCT02830165|OG000|Outcome|Treatment Stereotactic Body Radiotherapy (SBRT)|Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
10782490|NCT02830165|OG000|Outcome|Stereotactic Body Radiation Therapy (SBRT)|Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
11193922|NCT02148952|FG000|Participant Flow|Intervention Health Facility Participants|"Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193923|NCT02148952|FG001|Participant Flow|Control Health Facility Participants|"Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Matched control facilities provided comparison for intervention facilities."
10782491|NCT02830165|OG000|Outcome|Treatment Stereotactic Body Radiotherapy (SBRT)|Change in score from baseline at 12 months. Quality-of-Life Assessment: Ancillary studies
11339962|NCT03642873|OG003|Outcome|Treatment C (Test) - Plasma Hydrocodone Bitartrate|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state.
10782492|NCT02830165|EG000|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
10782493|NCT02784704|BG000|Baseline|Eravacycline|Eravacycline 1.0 mg/kg q12h
10782494|NCT02784704|BG001|Baseline|Meropenem|Meropenem 1 g q8h
10782495|NCT02784704|BG002|Baseline|Total|Total of all reporting groups
10782496|NCT02784704|FG000|Participant Flow|Eravacycline|Eravacycline 1.0mg/kg q12h
10782497|NCT02784704|FG001|Participant Flow|Meropenem|Meropenem 1g q8h
10782498|NCT02784704|OG000|Outcome|Eravacycline|Eravacycline 1.0mg/kg q12h
10782499|NCT02784704|OG001|Outcome|Meropenem|Meropenem 1g q8h
10782500|NCT02784704|OG000|Outcome|Eravacycline|Eravacycline 1.0 mg/kg q12h
10782501|NCT02784704|OG001|Outcome|Meropenem|Meropenem 1.0g q8h
10782502|NCT02784704|EG000|Reported Event|Eravacycline|Eravacycline 1 mg/kg q12h
10782503|NCT02784704|EG001|Reported Event|Meropenem|Meropenem 1 g q8h
10801651|NCT03529773|OG003|Outcome|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801652|NCT03529773|OG006|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801653|NCT03529773|OG008|Outcome|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801654|NCT03529773|OG004|Outcome|Sentinel Cohort: RSV 240 mcg Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination
10801655|NCT03529773|OG005|Outcome|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801656|NCT03529773|OG007|Outcome|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801657|NCT03529773|OG000|Outcome|Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years:|Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801658|NCT03529773|OG001|Outcome|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1
10801659|NCT03529773|EG000|Reported Event|Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801660|NCT03529773|EG001|Reported Event|Sentinel Cohort: RSV 120 mcg Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801661|NCT03529773|EG002|Reported Event|Sentinel Cohort: RSV 240 mcg Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801662|NCT03529773|EG003|Reported Event|Sentinel Cohort: Placebo Age 18-49 Years|Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
10801663|NCT03529773|EG004|Reported Event|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801664|NCT03529773|EG005|Reported Event|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801665|NCT03529773|EG006|Reported Event|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801666|NCT03529773|EG007|Reported Event|Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801667|NCT03529773|EG008|Reported Event|Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801668|NCT03529773|EG009|Reported Event|Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years|Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
10801669|NCT03529773|EG010|Reported Event|Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years|Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
10801670|NCT03529773|EG011|Reported Event|Sentinel Cohort: RSV 120 mcg Age 50-85 Years|Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801671|NCT03529773|EG012|Reported Event|Sentinel Cohort: RSV 240 mcg Age 50-85 Years|Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
10801672|NCT03529773|EG013|Reported Event|Sentinel Cohort: Placebo Age 50-85 Years|Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
11339963|NCT03642873|OG000|Outcome|Treatment A|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state
10782504|NCT04831515|BG000|Baseline|Overall Study|"daily disposable soft contact lens - test lens~Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.~Lens A: daily disposable soft contact lens - test lens~Lens B: daily disposable soft contact lens - control lens"
10782505|NCT04831515|FG000|Participant Flow|Lens A, Then Lens B|"Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.~Lens A: daily disposable soft contact lens - test lens~Lens B: daily disposable soft contact lens - control lens"
10782506|NCT04831515|FG001|Participant Flow|Lens B, Then Lens A|"Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.~Lens A: daily disposable soft contact lens - test lens~Lens B: daily disposable soft contact lens - control lens"
10782507|NCT04831515|OG000|Outcome|Lens A|"Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.~Lens A: daily disposable soft contact lens - test lens"
10782508|NCT04831515|OG001|Outcome|Lens B|"Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.~Lens B: daily disposable soft contact lens - control lens"
10782509|NCT04831515|EG000|Reported Event|Lens A|"Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.~Lens A: daily disposable soft contact lens - test lens"
10782510|NCT04831515|EG001|Reported Event|Lens B|"Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.~Lens B: daily disposable soft contact lens - control lens"
10964574|NCT00878189|EG005|Reported Event|PF-03084014 150 mg BID in Solid Tumor Participants|PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964575|NCT00878189|EG006|Reported Event|PF-03084014 150 mg BID in T-ALL/LBL Participants|PF-03084014 150 mg was administered orally BID to participants with T-ALL/LBL as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
10964576|NCT00878189|EG007|Reported Event|PF-03084014 220 mg BID in Solid Tumor Participants|PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964577|NCT00878189|EG008|Reported Event|PF-03084014 330 mg BID in Solid Tumor Participants|PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
10964578|NCT00878215|BG000|Baseline|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
10964579|NCT00878215|BG001|Baseline|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
10964580|NCT00878215|BG002|Baseline|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
11339964|NCT03642873|OG001|Outcome|Treatment B|Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
11339965|NCT03642873|OG002|Outcome|Treatment C|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
10964581|NCT00878215|BG003|Baseline|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
10964582|NCT00878215|BG004|Baseline|Total|Total of all reporting groups
10964583|NCT00878215|FG000|Participant Flow|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
10964584|NCT00878215|FG001|Participant Flow|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
10964585|NCT00878215|FG002|Participant Flow|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
10964586|NCT00878215|FG003|Participant Flow|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
11339966|NCT03642873|EG000|Reported Event|Treatment A|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state
10964587|NCT00878215|OG000|Outcome|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
10964588|NCT00878215|OG000|Outcome|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
10964589|NCT00878215|OG000|Outcome|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
10782524|NCT04253834|BG000|Baseline|Incentive Spirometer Control Arm|Participants using the incentive spirometer after surgery.
10782525|NCT04253834|BG001|Baseline|GO2 Mouthpiece|Participants using the GO2 Mouthpiece after surgery.
10782526|NCT04253834|BG002|Baseline|Total|Total of all reporting groups
10782527|NCT04253834|FG000|Participant Flow|Incentive Spirometer Control Arm|Participants using the incentive spirometer after surgery.
10782528|NCT04253834|FG001|Participant Flow|GO2 Mouthpiece|Participants using the bidirectional oxygenation valve, GO2 Mouthpiece, after surgery.
11193924|NCT02148952|OG000|Outcome|Intervention Health Facility Participants|"Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193925|NCT02148952|OG001|Outcome|Control Health Facility Participants|"Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Matched control facilities provided comparison for intervention facilities."
11243320|NCT02502149|OG000|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
10782529|NCT04253834|OG000|Outcome|Incentive Spirometer Control Arm|Participants using the incentive spirometer after surgery.
10782530|NCT04253834|OG001|Outcome|GO2 Mouthpiece|Participants using the GO2 Mouthpiece after surgery.
10782531|NCT04253834|EG000|Reported Event|Control Arm|Participants using the incentive spirometer after surgery.
10782532|NCT04253834|EG001|Reported Event|GO2 Mouthpiece|Participants using the GO2 Mouthpiece after surgery.
10782533|NCT03881059|BG000|Baseline|Placebo|In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
10782534|NCT03881059|BG001|Baseline|BMS-986165 6 mg|In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782535|NCT03881059|BG002|Baseline|BMS-986165 12 mg|In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782536|NCT03881059|BG003|Baseline|Total|Total of all reporting groups
10782537|NCT03881059|FG000|Participant Flow|Placebo|In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
10782538|NCT03881059|FG001|Participant Flow|BMS-986165 6 mg|In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782539|NCT03881059|FG002|Participant Flow|BMS-986165 12 mg|In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782540|NCT03881059|OG000|Outcome|Placebo|In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
10782541|NCT03881059|OG001|Outcome|BMS-986165 6 mg|In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782542|NCT03881059|OG002|Outcome|BMS-986165 12 mg|In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
10782543|NCT03881059|EG000|Reported Event|Only Part A:Placebo|In Part A, Placebo matching BMS-986165.
10782544|NCT03881059|EG001|Reported Event|Only Part A:BMS-986165 6 mg QD|In Part A, BMS-986165 6 mg administered QD for 16 weeks.
10782545|NCT03881059|EG002|Reported Event|Only Part A:BMS-986165 12 mg QD|In Part A, BMS-986165 12 mg administered QD for 16 weeks.
10782546|NCT03881059|EG003|Reported Event|Part A: Placebo + Part B: Ustekinumab SQ|In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
10964590|NCT00878215|OG000|Outcome|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
10782547|NCT03881059|EG004|Reported Event|BMS-986165 6 mg in Part A and Part B|In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg
10782548|NCT03881059|EG005|Reported Event|Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ|In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ.
10782549|NCT03881059|EG006|Reported Event|BMS-986165 12 mg in Part A and Part B|In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg
10782550|NCT03881059|EG007|Reported Event|Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ|In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
10782551|NCT03878277|BG000|Baseline|Cold Brew Coffee|"6 days of drinking 1 bottle of Starbucks® Cold brew 325ml [205 mg caffeine] every morning between 6am-9am.~Starbucks® Cold brew - 325ml bottle: Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit"
10782552|NCT03878277|FG000|Participant Flow|Cold Brew Coffee|"6 days of drinking 1 bottle of Starbucks® Cold brew 325ml [205 mg caffeine] every morning between 6am-9am.~Starbucks® Cold brew - 325ml bottle: Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit"
10782553|NCT03878277|OG000|Outcome|Cold Brew Coffee|"6 days of drinking 1 bottle of Starbucks® Cold brew 325ml [205 mg caffeine] every morning between 6am-9am.~Starbucks® Cold brew - 325ml bottle: Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit"
10782554|NCT03878277|EG000|Reported Event|Cold Brew Coffee|"6 days of drinking 1 bottle of Starbucks® Cold brew 325ml [205 mg caffeine] every morning between 6am-9am.~Starbucks® Cold brew - 325ml bottle: Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit"
11339967|NCT03642873|EG001|Reported Event|Treatment B|Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
11339968|NCT03642873|EG002|Reported Event|Treatment C|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state
10801673|NCT03529773|EG014|Reported Event|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801674|NCT03529773|EG015|Reported Event|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801675|NCT03529773|EG016|Reported Event|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:|Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801676|NCT03529773|EG017|Reported Event|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801677|NCT03529773|EG018|Reported Event|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801678|NCT03529773|EG019|Reported Event|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801679|NCT03529773|EG020|Reported Event|Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801680|NCT03529773|EG021|Reported Event|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11193926|NCT02148952|OG000|Outcome|Intervention Health Facility Participants|"Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
10782555|NCT03450629|BG000|Baseline|PDP-716|Brimonidine Tartrate Ophthalmic Suspension
10782556|NCT03450629|BG001|Baseline|Brimonidine Tartrate Ophthalmic Solution|Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
10782557|NCT03450629|BG002|Baseline|Total|Total of all reporting groups
10782558|NCT03450629|FG000|Participant Flow|PDP-716|Brimonidine tartrate 0.35% ophthalmic suspension (SPARC), QD
10782559|NCT03450629|FG001|Participant Flow|Brimonidine Tartrate Ophthalmic Solution|Brimonidine tartrate 0.1% ophthalmic solution (Alphagan P® 0.1%), TID
10782560|NCT03450629|OG000|Outcome|PDP-716|Brimonidine Tartrate Ophthalmic Suspension
10782561|NCT03450629|OG001|Outcome|Brimonidine Tartrate Ophthalmic Solution|Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
10782562|NCT03450629|EG000|Reported Event|PDP-716|Brimonidine Tartrate Ophthalmic Suspension
10782563|NCT03450629|EG001|Reported Event|Brimonidine Tartrate Ophthalmic Solution|Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
10782564|NCT03367403|BG000|Baseline|Donanemab Monotherapy (Donanemab-M)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
10782565|NCT03367403|BG001|Baseline|Placebo|Participants received placebo IV Q4W for up to 72 weeks.
10782566|NCT03367403|BG002|Baseline|Donanemab in Combination With LY3202626 (Donanemab-C)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks.
10782567|NCT03367403|BG003|Baseline|Total|Total of all reporting groups
10782568|NCT03367403|FG000|Participant Flow|Donanemab Monotherapy (Donanemab-M)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
10782569|NCT03367403|FG001|Participant Flow|Placebo|Participants received placebo IV Q4W for up to 72 weeks.
10782570|NCT03367403|FG002|Participant Flow|Donanemab in Combination With LY3202626 (Donanemab-C)|Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks.
10782571|NCT03367403|OG000|Outcome|Donanemab Monotherapy (Donanemab-M)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
10782572|NCT03367403|OG001|Outcome|Placebo|Participants received placebo IV Q4W for up to 72 weeks.
10782573|NCT03367403|OG000|Outcome|Donanemab Monotherapy (Donanemab-M)|Participants received 700 mg Donanemab IV Q4W x 3 doses, then 1400 mg Donanemab IV Q4W for up to 72 weeks.
11193927|NCT02148952|OG001|Outcome|Control Health Facility Participants|"Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Matched control facilities provided comparison for intervention facilities."
10782574|NCT03367403|EG000|Reported Event|Donanemab Monotherapy (Donanemab-M)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
10782575|NCT03367403|EG001|Reported Event|Placebo|Participants received placebo IV Q4W for up to 72 weeks.
10782576|NCT03367403|EG002|Reported Event|Donanemab in Combination With LY3202626 (Donanemab-C)|Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks.
10782577|NCT03286426|BG000|Baseline|Vision/Eye Screening|"Image of back of each eye along with color vision and visual acuity assessment if able.~Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam."
10782578|NCT03286426|FG000|Participant Flow|Vision/Eye Screening|"Image of back of each eye along with color vision and visual acuity assessment if able.~Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam."
10782579|NCT03286426|OG000|Outcome|Vision/Eye Screening|"Image of back of each eye along with color vision and visual acuity assessment if able.~Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam."
10782580|NCT03286426|EG000|Reported Event|Vision/Eye Screening|"Image of back of each eye along with color vision and visual acuity assessment if able.~Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam."
10782581|NCT03135249|BG000|Baseline|Alemtuzumab Treatment.|"Patients with relapsing-remitting multiple sclerosis previously treated with natalizumab, the following treatment arms with alemtuzumab will be implemented:~Year One: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for five days to be given within eight hours after dilution.~Year Two: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for three days to be given within eight hours after dilution.~Alemtuzumab: Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells."
10782582|NCT03135249|FG000|Participant Flow|Alemtuzumab Treatment.|"Patients with relapsing-remitting multiple sclerosis previously treated with natalizumab, the following treatment arms with alemtuzumab will be implemented:~Year One: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for five days to be given within eight hours after dilution.~Year Two: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for three days to be given within eight hours after dilution.~Alemtuzumab: Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells."
11193928|NCT02148952|OG000|Outcome|Intervention Health Facility Participants|"Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193929|NCT02148952|OG001|Outcome|Control Health Facility Participants|"Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation.~Matched control facilities provided comparison for intervention facilities."
11243321|NCT02502149|OG001|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
10782583|NCT03135249|OG000|Outcome|Alemtuzumab Treatment.|"Patients with relapsing-remitting multiple sclerosis previously treated with natalizumab, the following treatment arms with alemtuzumab will be implemented:~Year One: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for five days to be given within eight hours after dilution.~Year Two: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for three days to be given within eight hours after dilution.~Alemtuzumab: Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells."
10782584|NCT03135249|EG000|Reported Event|Alemtuzumab Treatment.|"Patients with relapsing-remitting multiple sclerosis previously treated with natalizumab, the following treatment arms with alemtuzumab will be implemented:~Year One: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for five days to be given within eight hours after dilution.~Year Two: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for three days to be given within eight hours after dilution.~Alemtuzumab: Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells."
10782585|NCT02818582|BG000|Baseline|GS-5734 100mg Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
10782586|NCT02818582|BG001|Baseline|Normal Saline Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
10782587|NCT02818582|BG002|Baseline|Total|Total of all reporting groups
10782588|NCT02818582|FG000|Participant Flow|GS-5734 100mg Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
10782589|NCT02818582|FG001|Participant Flow|Normal Saline Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
10782590|NCT02818582|OG000|Outcome|GS-5734 100mg Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
10782591|NCT02818582|OG001|Outcome|Normal Saline Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
10782592|NCT02818582|EG000|Reported Event|GS-5734 100mg Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
10782593|NCT02818582|EG001|Reported Event|Normal Saline Given Intravenously Daily for 5 Days|Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
10782594|NCT02809677|BG000|Baseline|Caregiver Child Dyad|This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
10782595|NCT02809677|FG000|Participant Flow|Caregiver Child Dyad|Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
10782596|NCT02809677|OG000|Outcome|Caregiver Child Dyad|This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
10782597|NCT02809677|OG000|Outcome|Caregiver Child Dyad|Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
10782598|NCT02809677|EG000|Reported Event|Caregiver Child Dyad|This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study.
11193930|NCT02148952|OG000|Outcome|Intervention Health Facility Participants|"Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193931|NCT02148952|OG001|Outcome|Control Health Facility Participants|"Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation.~Matched control facilities provided comparison for intervention facilities."
11193932|NCT02148952|OG000|Outcome|Intervention Health Facility Participants|"Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193933|NCT02148952|OG001|Outcome|Control Health Facility Participants|"Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation.~Matched control facilities provided comparison for intervention facilities."
11380549|NCT01425008|EG017|Reported Event|Q2D Dose Expansion Phase: TAK-580 (BRAF+)|TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
11380550|NCT01425008|EG018|Reported Event|QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive|TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
11243322|NCT02502149|OG000|Outcome|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
10782599|NCT02728258|BG000|Baseline|Copanlisib|IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
10782600|NCT02728258|FG000|Participant Flow|Copanlisib|IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
10782601|NCT02728258|OG000|Outcome|Copanlisib|IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
10782602|NCT02728258|EG000|Reported Event|Treatment (Copanlisib)|"Patients receive copanlisib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Copanlisib: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10782603|NCT02554253|BG000|Baseline|Ketamine|"Ketamine induction~Ketamine: Ketamine used for induction"
11193934|NCT02148952|EG000|Reported Event|Intervention Health Facility Participants|"Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.~WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection."
11193935|NCT02148952|EG001|Reported Event|Control Health Facility Participants|"Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.~Matched control facilities provided comparison for intervention facilities."
11193936|NCT02149108|BG000|Baseline|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11193937|NCT02149108|BG001|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11193938|NCT02149108|BG002|Baseline|Total|Total of all reporting groups
11193939|NCT02149108|FG000|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10782604|NCT02554253|BG001|Baseline|Propofol|"Propofol induction~Propofol: Propofol used for induction"
11193940|NCT02149108|FG001|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11193941|NCT02149108|OG000|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11193942|NCT02149108|OG001|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10782605|NCT02554253|BG002|Baseline|Total|Total of all reporting groups
10782606|NCT02554253|FG000|Participant Flow|Ketamine|"Ketamine induction~Ketamine: Ketamine used for induction"
10782607|NCT02554253|FG001|Participant Flow|Propofol|"Propofol induction~Propofol: Propofol for induction"
11193943|NCT02149108|EG000|Reported Event|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11193944|NCT02149108|EG001|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
10782608|NCT02554253|OG000|Outcome|Ketamine|"Ketamine induction~Ketamine: Ketamine used for induction"
10782609|NCT02554253|OG001|Outcome|Propofol|"Propofol induction~Propofol: Propofol for induction"
10782610|NCT02554253|OG001|Outcome|Propofol|"Propofol induction~Propofol: Propofol used for induction"
10782611|NCT02554253|EG000|Reported Event|Ketamine|"Ketamine induction~Ketamine: Ketamine used for induction"
10782612|NCT02554253|EG001|Reported Event|Propofol|"Propofol induction~Propofol: Propofol used for induction"
10801681|NCT03529773|EG022|Reported Event|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801682|NCT03529773|EG023|Reported Event|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801683|NCT03529773|EG024|Reported Event|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11193945|NCT02149173|BG000|Baseline|Diagnostic (F-18 FES PET/CT)|Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
11193946|NCT02149173|FG000|Participant Flow|Diagnostic (F-18 FES PET/CT)|Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
11380551|NCT04425902|BG000|Baseline|All Treated Participants|All treated participants received a single dose of treatment A: Probe substrates (caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) on Day 1; followed by treatment B- GSK3640254 200 mg once daily from Days 11 to 20; further followed by treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380552|NCT04425902|FG000|Participant Flow|All Treated Participants|All treated participants received a single dose of treatment A: Probe substrates (caffeine 200 milligram [mg], metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) on Day 1; followed by treatment B- GSK3640254 200 mg once daily from Days 11 to 20; further followed by treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380553|NCT04425902|OG000|Outcome|Treatment A: Probe Substrates|All treated participants received a single dose of treatment A: Probe substrates (caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) on Day 1.
11380554|NCT04425902|OG001|Outcome|Treatment C: Probe Substrates + GSK3640254 200 mg|All treated participants received a single dose of treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380555|NCT04425902|OG001|Outcome|Treatment B: GSK3640254 200 mg|All treated participants received a single dose of treatment treatment B- GSK3640254 200 mg once daily from Days 11 to 20.
11380556|NCT04425902|OG002|Outcome|Treatment C: Probe Substrates + GSK3640254 200 mg|All treated participants received a single dose of treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380557|NCT04425902|OG000|Outcome|Treatment B: GSK3640254 200 mg|All treated participants received a single dose of treatment treatment B- GSK3640254 200 mg once daily from Days 11 to 20.
11380558|NCT04425902|OG000|Outcome|Treatment C: Probe Substrates + GSK3640254 200 mg|All treated participants received a single dose of treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380559|NCT04425902|EG000|Reported Event|Treatment A: Probe Substrates|All treated participants received a single dose of treatment A: Probe substrates (caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) on Day 1.
11380560|NCT04425902|EG001|Reported Event|Treatment B: GSK3640254 200 mg|All treated participants received a single dose of treatment treatment B- GSK3640254 200 mg once daily from Days 11 to 20.
11380561|NCT04425902|EG002|Reported Event|Treatment C: Probe Substrates + GSK3640254 200 mg|All treated participants received a single dose of treatment C: Probe substrates (Caffeine 200 mg, metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg, and pravastatin 40 mg) co-administered with GSK3640254 200 mg on Day 21.
11380562|NCT04072146|BG000|Baseline|OC-01 (Varenicline Solution) Nasal Spray 0.12 mg Then Varenicline Oral Tablet 1 mg|Treatment sequence A: single oral dose of 1 mg varenicline tablet, washout for 14 days, then treatment sequence B: intranasal dose of 0.12 mg OC-01 nasal spray.
11380563|NCT04072146|BG001|Baseline|Varenicline Oral Tablet 1 mg Then OC-01 (Varenicline Solution) Nasal Spray 0.12 mg|Treatment sequence B: intranasal dose of 0.12 mg OC-01 nasal spray, washout for 14 days, then treatment sequence A: single oral dose of 1 mg varenicline tablet.
10782613|NCT01524536|BG000|Baseline|Steroid Challenge|A single oral dose of prednisone (1 mg/kg rounded to the nearest 5mg) was administered to all participants. The following day, participant began glucocorticoid therapy of prednisone 30 mg oral daily for one week followed by a standardized taper until a minimally effective dose was achieved or participant tapered to prednisone 5 mg oral daily.
11193947|NCT02149173|OG000|Outcome|FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy|Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2 weeks after starting therapy
11193948|NCT02149173|OG001|Outcome|FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy|Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 8 weeks after starting therapy
11380564|NCT04072146|BG002|Baseline|Total|Total of all reporting groups
11380565|NCT04072146|FG000|Participant Flow|Varenicline Oral Tablet 1 mg, Then OC-01 (Varenicline) Nasal 0.12 mg|Treatment sequence A: single oral dose of 1 mg varenicline tablet, washout for 14 days, then treatment sequence B intranasal dose of 0.12 mg OC-01 nasal spray.
10782614|NCT01524536|FG000|Participant Flow|Steroid Challenge|A single oral dose of prednisone (1 mg/kg rounded to the nearest 5mg) was administered to all participants. The following day, participant began glucocorticoid therapy of prednisone 30 mg oral daily for one week followed by a standardized taper until a minimally effective dose was achieved or participant tapered to prednisone 5 mg oral daily.
11380566|NCT04072146|FG001|Participant Flow|OC-01 (Varenicline Solution) Nasal Spray 0.12 mg, Then Varenicline Oral Tablet 1 mg|Treatment sequence B intranasal dose of 0.12 mg OC-01 nasal spray, washout for 14 days, then treatment sequence A: single oral dose of 1 mg varenicline tablet.
10782615|NCT01524536|OG000|Outcome|Steroid Challenge - Responders|A single oral dose of prednisone (1 mg/kg rounded to the nearest 5mg) was administered to all participants. The following day, participant began glucocorticoid therapy of prednisone 30 mg oral daily for one week followed by a standardized taper until a minimally effective dose was achieved or participant tapered to prednisone 5 mg oral daily.
10782616|NCT01524536|OG001|Outcome|Steroid Challenge - Non-responders|A single oral dose of prednisone (1 mg/kg rounded to the nearest 5mg) was administered to all participants. The following day, participant began glucocorticoid therapy of prednisone 30 mg oral daily for one week followed by a standardized taper until a minimally effective dose was achieved or participant tapered to prednisone 5 mg oral daily.
10782617|NCT01524536|OG000|Outcome|Steroid Challenge - Glucocorticoid Responsiveness|Participants with hypereosinophilic syndromes (IHES) that achieved glucocorticoid responsiveness defined as final minimally effective dose of prednisone of 0mg-15mg
10782618|NCT01524536|OG001|Outcome|Steroid Challenge - Glucocorticoid Suboptimal Responsiveness|Participants with hypereosinophilic syndromes (HES) with suboptimal glucocorticoid responsiveness defined as achieving final minimally effective dose of prednisone of 16mg-40mg
10782619|NCT01524536|OG002|Outcome|Steroid Challenge - Glucocorticoid Unresponsiveness|Participants with hypereosinophilic syndromes (HES) that were not responsive to prednisone defined as no decline of absolute eosinophil count (AEC) below 1000/mm^3 after one week of prednisone 30 mg daily, followed by 2 days of prednisone 60 mg daily
10782620|NCT01524536|OG000|Outcome|Steroid Challenge - Glucocorticoid Responsiveness|Participants with hypereosinophilic syndromes (HES) that achieved glucocorticoid responsiveness defined as final minimally effective dose of prednisone of 0mg-15mg
10782621|NCT01524536|OG002|Outcome|Steroid Challenge - Glucocorticoid Unresponsiveness|Participants with hypereosinophilic syndromes (HES) that were not responsive to prednisone defined as no decline of absolute eosinophil count (AEC) below 1000/mm^3 after one week of prednisone 30 mg daily, followed by 2 days of prednisone 60 mg daily.
10782622|NCT01524536|EG000|Reported Event|Steroid Challenge|A single oral dose of prednisone (1 mg/kg rounded to the nearest 5mg) was administered to all participants. The following day, participant began glucocorticoid therapy of prednisone 30 mg oral daily for one week followed by a standardized taper until a minimally effective dose was achieved or participant tapered to prednisone 5 mg oral daily.
10782623|NCT01307046|BG000|Baseline|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
11193949|NCT02149173|OG002|Outcome|FES-imaging After 2-8 Weeks of ER Blocking Therapy|Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2-8 weeks after starting estrogen receptor blocking therapy.
10782624|NCT01307046|BG001|Baseline|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
10782625|NCT01307046|BG002|Baseline|Total|Total of all reporting groups
10782626|NCT01307046|FG000|Participant Flow|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
10782627|NCT01307046|FG001|Participant Flow|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
10782628|NCT01307046|OG000|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
10782629|NCT01307046|OG001|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
10782630|NCT01307046|EG000|Reported Event|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
10782631|NCT01307046|EG001|Reported Event|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
10782632|NCT01307033|BG000|Baseline|MK-0954H (L50/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
10782633|NCT01307033|BG001|Baseline|MK-0954A (L100/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
10782634|NCT01307033|BG002|Baseline|Total|Total of all reporting groups
10782635|NCT01307033|FG000|Participant Flow|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
10782636|NCT01307033|FG001|Participant Flow|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
10782637|NCT01307033|FG002|Participant Flow|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
10782638|NCT01307033|FG003|Participant Flow|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
10782639|NCT01307033|OG000|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
10782640|NCT01307033|OG001|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).
10782641|NCT01307033|OG000|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
10782642|NCT01307033|OG001|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
11193950|NCT02149173|OG000|Outcome|Quantitative Uptake|number of lesions with quantitative uptake (SULmax) above 0.85 (the value indicating a negative lesion)
10782643|NCT01307033|OG000|Outcome|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
10782644|NCT01307033|OG001|Outcome|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
10782645|NCT01307033|EG000|Reported Event|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
10782646|NCT01307033|EG001|Reported Event|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
10782647|NCT01307033|EG002|Reported Event|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
10782648|NCT01307033|EG003|Reported Event|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
10782649|NCT00739674|BG000|Baseline|Losartan-Based Regimen Alone (L Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
10782650|NCT00739674|BG001|Baseline|Diet Management and Losartan-Based Regimen (DML Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
10782651|NCT00739674|BG002|Baseline|Total|Total of all reporting groups
10782652|NCT00739674|FG000|Participant Flow|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
10782653|NCT00739674|FG001|Participant Flow|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
10782654|NCT00739674|OG000|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
10782655|NCT00739674|OG001|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
11243323|NCT02502149|OG001|Outcome|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
10782656|NCT00739674|EG000|Reported Event|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
10782657|NCT00739674|EG001|Reported Event|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
10782658|NCT00546754|BG000|Baseline|Losartan 50 mg/HCTZ 12.5 mg|"Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
10782659|NCT00546754|BG001|Baseline|Valsartan 80 mg/HCTZ 12.5 mg|"Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
10782660|NCT00546754|BG002|Baseline|Total|Total of all reporting groups
10782661|NCT00546754|FG000|Participant Flow|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782662|NCT00546754|FG001|Participant Flow|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782663|NCT00546754|OG000|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782664|NCT00546754|OG001|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782665|NCT00546754|EG000|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782666|NCT00546754|EG001|Reported Event|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
10782667|NCT00479713|BG000|Baseline|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
10782668|NCT00479713|BG001|Baseline|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
10782669|NCT00479713|BG002|Baseline|Total|Total of all reporting groups
10782670|NCT00479713|FG000|Participant Flow|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
10782671|NCT00479713|FG001|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
10782672|NCT00479713|OG000|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
10782673|NCT00479713|OG001|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
10782674|NCT00479713|EG000|Reported Event|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
10782675|NCT00479713|EG001|Reported Event|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
10782676|NCT00406783|BG000|Baseline|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
10782677|NCT00406783|BG001|Baseline|Placebo Tablet|placebo tablet, once daily for 15 days
10782678|NCT00406783|BG002|Baseline|Total|Total of all reporting groups
10782679|NCT00406783|FG000|Participant Flow|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
10782680|NCT00406783|FG001|Participant Flow|Placebo Tablet|placebo tablet, once daily for 15 days
10782681|NCT00406783|OG000|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
10782682|NCT00406783|OG001|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
10782683|NCT00406783|EG000|Reported Event|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
10782684|NCT00406783|EG001|Reported Event|Placebo Tablet|placebo tablet, once daily for 15 days
10782685|NCT00405964|BG000|Baseline|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
10782686|NCT00405964|BG001|Baseline|Placebo Tablet|Matching placebo, orally daily.
10782687|NCT00405964|BG002|Baseline|Total|Total of all reporting groups
10782688|NCT00405964|FG000|Participant Flow|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
10782689|NCT00405964|FG001|Participant Flow|Placebo Tablet|Matching placebo, orally daily.
10782690|NCT00405964|OG000|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
10782691|NCT00405964|OG001|Outcome|Placebo Tablet|Matching placebo, orally daily.
10782692|NCT00405964|EG000|Reported Event|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
10782693|NCT00405964|EG001|Reported Event|Placebo Tablet|Matching placebo, orally daily.
10782694|NCT00383721|BG000|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
10782695|NCT00383721|BG001|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
10782696|NCT00383721|BG002|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
10782697|NCT00383721|BG003|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
10782698|NCT00383721|BG004|Baseline|Placebo|Placebo MDI BID for 26 weeks.
10782699|NCT00383721|BG005|Baseline|Total|Total of all reporting groups
10782700|NCT00383721|FG000|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
10782701|NCT00383721|FG001|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
10782702|NCT00383721|FG002|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
10782703|NCT00383721|FG003|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
10782704|NCT00383721|FG004|Participant Flow|Placebo|Placebo MDI BID for 26 weeks.
10782705|NCT00383721|OG000|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
10782706|NCT00383721|OG001|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
10782707|NCT00383721|OG002|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
10782708|NCT00383721|OG003|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
10782709|NCT00383721|OG004|Outcome|Placebo|Placebo MDI BID for 26 weeks.
10782710|NCT00383721|EG000|Reported Event|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
10782711|NCT00383721|EG001|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
10782712|NCT00383721|EG002|Reported Event|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
10782713|NCT00383721|EG003|Reported Event|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
10782714|NCT00383721|EG004|Reported Event|Placebo|Placebo MDI BID for 26 weeks.
10782715|NCT00383552|BG000|Baseline|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
10782716|NCT00383552|BG001|Baseline|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
10782717|NCT00383552|BG002|Baseline|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
10782718|NCT00383552|BG003|Baseline|Placebo BID|Placebo twice daily (BID)
10782719|NCT00383552|BG004|Baseline|Total|Total of all reporting groups
10782720|NCT00383552|FG000|Participant Flow|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
10782721|NCT00383552|FG001|Participant Flow|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
10782722|NCT00383552|FG002|Participant Flow|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
10782723|NCT00383552|FG003|Participant Flow|Placebo BID|Placebo twice daily (BID)
10782724|NCT00383552|OG000|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
10782725|NCT00383552|OG001|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
10782726|NCT00383552|OG002|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
10782727|NCT00383552|OG003|Outcome|Placebo BID|Placebo twice daily (BID)
10782728|NCT00383552|OG000|Outcome|MF/F MDI 100/10 Mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID).
10782729|NCT00383552|OG001|Outcome|MF MDI 100 Mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID).
10782730|NCT00383552|OG002|Outcome|F MDI 10 Mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID).
11243324|NCT02502149|OG001|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 and 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
10782731|NCT00383552|OG003|Outcome|Placebo BID|Placebo twice daily (BID).
10782732|NCT00383552|EG000|Reported Event|OL MF MDI 100 MCG BID|Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.
10782733|NCT00383552|EG001|Reported Event|MF/F MDI 100/10 MCG BID|
10782734|NCT00383552|EG002|Reported Event|MF MDI 100 MCG BID|
10782735|NCT00383552|EG003|Reported Event|F MDI 10 MCG BID|
10782736|NCT00383552|EG004|Reported Event|PLACEBO|
10782737|NCT00383435|BG000|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
10782738|NCT00383435|BG001|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
10782739|NCT00383435|BG002|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
10782740|NCT00383435|BG003|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
10782741|NCT00383435|BG004|Baseline|Placebo|Placebo MDI BID for 26 weeks
10782742|NCT00383435|BG005|Baseline|Total|Total of all reporting groups
10782743|NCT00383435|FG000|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
10782744|NCT00383435|FG001|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
10782745|NCT00383435|FG002|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
10782746|NCT00383435|FG003|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
10782747|NCT00383435|FG004|Participant Flow|Placebo|Placebo MDI BID for 26 weeks
10782748|NCT00383435|OG000|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
10782749|NCT00383435|OG001|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
10782750|NCT00383435|OG002|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
10782751|NCT00383435|OG003|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
10782752|NCT00383435|OG004|Outcome|Placebo|Placebo MDI BID for 26 weeks
10782753|NCT00383435|EG000|Reported Event|MF/F MDI 200/10 MCG BID|
10782754|NCT00383435|EG001|Reported Event|MF/F MDI 400/10 MCG BID|
10782755|NCT00383435|EG002|Reported Event|MF MDI 400 MCG BID|
10782756|NCT00383435|EG003|Reported Event|F MDI 10 MCG BID|
10782757|NCT00383435|EG004|Reported Event|PLACEBO|
10782758|NCT00381485|BG000|Baseline|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782759|NCT00381485|BG001|Baseline|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782760|NCT00381485|BG002|Baseline|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
10782761|NCT00381485|BG003|Baseline|Total|Total of all reporting groups
10782762|NCT00381485|FG000|Participant Flow|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
10782763|NCT00381485|FG001|Participant Flow|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782764|NCT00381485|FG002|Participant Flow|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782765|NCT00381485|FG003|Participant Flow|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
10782766|NCT00381485|OG000|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782767|NCT00381485|OG001|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782768|NCT00381485|OG002|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
10782769|NCT00381485|EG000|Reported Event|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782770|NCT00381485|EG001|Reported Event|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
10782771|NCT00381485|EG002|Reported Event|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
10782772|NCT00381485|EG003|Reported Event|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
10782773|NCT00379288|BG000|Baseline|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782774|NCT00379288|BG001|Baseline|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782775|NCT00379288|BG002|Baseline|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
10782776|NCT00379288|BG003|Baseline|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
10782777|NCT00379288|BG004|Baseline|Total|Total of all reporting groups
10782778|NCT00379288|FG000|Participant Flow|MF/F 200/10 mcg BID|mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782779|NCT00379288|FG001|Participant Flow|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782780|NCT00379288|FG002|Participant Flow|F/SC 250/50 mcg BID|fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
10782781|NCT00379288|FG003|Participant Flow|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
10782782|NCT00379288|OG000|Outcome|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782783|NCT00379288|OG001|Outcome|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
11380567|NCT04072146|OG000|Outcome|Varenicline Oral Tablet 1 mg|OC-01 0.12 mg was administered intranasally 50 ul into each nostril in a fasted state Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg
10782784|NCT00379288|OG002|Outcome|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
10782785|NCT00379288|OG003|Outcome|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
10782786|NCT00379288|EG000|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782787|NCT00379288|EG001|Reported Event|MF/F MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
10782788|NCT00379288|EG002|Reported Event|F/SC MDI 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
10782789|NCT00379288|EG003|Reported Event|F/SC MDI 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
10782790|NCT00378378|BG000|Baseline|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
10964591|NCT00878215|EG000|Reported Event|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
10782791|NCT00378378|BG001|Baseline|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
10782792|NCT00378378|BG002|Baseline|Pooled Placebo|All placebo groups were combined
10782793|NCT00378378|BG003|Baseline|Total|Total of all reporting groups
10782794|NCT00378378|FG000|Participant Flow|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
10782795|NCT00378378|FG001|Participant Flow|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
10782796|NCT00378378|FG002|Participant Flow|Pooled Placebo|All placebo groups were combined
10782797|NCT00378378|OG000|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
10782798|NCT00378378|OG001|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
10782799|NCT00378378|OG002|Outcome|Pooled Placebo|All placebo groups were combined
10782800|NCT00378378|EG000|Reported Event|MFNS 100 or 200 mcg QD|
10782801|NCT00378378|EG001|Reported Event|MFNS 100 or 200 mcg BID|
10782802|NCT00378378|EG002|Reported Event|Placebo|
10782803|NCT00089895|BG000|Baseline|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782804|NCT00089895|BG001|Baseline|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782805|NCT00089895|BG002|Baseline|Total|Total of all reporting groups
10782806|NCT00089895|FG000|Participant Flow|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782807|NCT00089895|FG001|Participant Flow|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782808|NCT00089895|OG000|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782809|NCT00089895|OG001|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782810|NCT00089895|EG000|Reported Event|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782811|NCT00089895|EG001|Reported Event|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
10782812|NCT02577354|BG000|Baseline|Treatment|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782813|NCT02577354|BG001|Baseline|Control/Crossover|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After the 120-day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
10782814|NCT02577354|BG002|Baseline|Total|Total of all reporting groups
10782815|NCT02577354|FG000|Participant Flow|Treatment|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level and participants instructed to deliver stimulation in two 30-minute sessions per day.
11380568|NCT04072146|OG001|Outcome|OC-01 (Varenicline) Nasal Spray 0.12 mg|Varenicline oral tablet 1mg was administered orally in a fasted stated with 200 ml water OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg.
11380569|NCT04072146|OG000|Outcome|OC-01 (Varenicline) Nasal Spray 0.12 mg|"OC-01 0.12 mg was administered intranasally 50 ul into each nostril in a fasted state~Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg"
11380570|NCT04072146|OG001|Outcome|Varenicline Oral Tablet 1 mg|"Varenicline oral tablet 1mg was administered orally in a fasted stated with 200 ml water~OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg"
11380571|NCT04072146|OG000|Outcome|OC-01 (Varenicline) Nasal Spray 0.12 mg|OC-01 0.12 mg was administered intranasally 50 ul into each nostril in a fasted state Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg
11380572|NCT04072146|OG001|Outcome|Varenicline Oral Tablet 1 mg|Varenicline oral tablet 1mg was administered orally in a fasted stated with 200 ml water OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg
11380573|NCT04072146|OG000|Outcome|Varenicline Oral Tablet 1mg, Then OC-01 (Varenicline Solution) Nasal Spray 0.12 mg|"OC-01 0.12 mg was administered intranasally 50 ul into each nostril in a fasted state~Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg: Cross over bioavailability study"
11380574|NCT04072146|OG001|Outcome|OC-01 (Varenicline Solution) Nasal Spray 0.12 mg, Then Varenicline Oral Tablet 1 mg|"Varenicline oral tablet 1mg was administered orally in a fasted stated with 200 ml water~OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg: Cross over bioavailability study"
11380575|NCT04072146|EG000|Reported Event|OC- 01 (Varenicline) Nasal Spray 0.12 mg|OC- 01 (varenicline) nasal spray 0.12 mg
11380576|NCT04072146|EG001|Reported Event|Varenicline Oral Tablet 1 mg|Varenicline oral tablet 1 mg
11380577|NCT03861481|BG000|Baseline|Placebo|Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks.
11380578|NCT03861481|BG001|Baseline|Rozanolixizumab|Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
11380579|NCT03861481|BG002|Baseline|Total|Total of all reporting groups
11380580|NCT03861481|FG000|Participant Flow|Placebo|Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks.
10782816|NCT02577354|FG001|Participant Flow|Control/Crossover|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
10782817|NCT02577354|OG000|Outcome|Treatment|ReActiv8 Implantable Stimulation System (patient-appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
11380581|NCT03861481|FG001|Participant Flow|Rozanolixizumab|Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
11380582|NCT03861481|OG000|Outcome|Placebo|Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks.
11380583|NCT03861481|OG001|Outcome|Rozanolixizumab|Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
11380584|NCT03861481|EG000|Reported Event|Placebo|Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks.
11380585|NCT03861481|EG001|Reported Event|Rozanolixizumab|Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
11380586|NCT03708198|BG000|Baseline|Intercostal Nerve Block|"The study participants will be given a standard 266 mg single dose injection of liposomal bupivacaine by the surgeon at the start of the surgery.~Liposomal Bupivacaine: intercostal block"
11380587|NCT03708198|FG000|Participant Flow|Intercostal Nerve Block|"The study participants will be given a standard 266 mg single dose injection of liposomal bupivacaine by the surgeon at the start of the surgery.~Liposomal Bupivacaine: intercostal block"
11380588|NCT03708198|OG000|Outcome|Intercostal Nerve Block|"The study participants will be given a standard 266 mg single dose injection of liposomal bupivacaine by the surgeon at the start of the surgery.~Liposomal Bupivacaine: intercostal block"
11380589|NCT03708198|EG000|Reported Event|Intercostal Nerve Block|"The study participants will be given a standard 266 mg single dose injection of liposomal bupivacaine by the surgeon at the start of the surgery.~Liposomal Bupivacaine: intercostal block"
11380590|NCT03692052|BG000|Baseline|AG-348|Participants with alpha or beta thalassemia received AG-348 50 mg BID, orally up to Week 6. Following Week 6, depending on the participants' safety and Hb concentrations, they could undergo one potential dose-level increase from 50 to 100 mg BID. After completion of the Core Period of 24 weeks, participants were eligible to continue to receive AG-348 in the Extension Period which is up to 10 years.
11380591|NCT03692052|FG000|Participant Flow|AG-348|Participants with alpha or beta thalassemia received AG-348 50 mg twice daily (BID), orally up to Week 6. Following Week 6, depending on the participants' safety and hemoglobin (Hb) concentrations, they could undergo one potential dose-level increase from 50 to 100 mg BID. After completion of the Core Period of 24 weeks, participants were eligible to continue to receive AG-348 in the Extension Period which is up to 10 years.
11380592|NCT03692052|OG000|Outcome|AG-348|Participants with alpha or beta thalassemia received AG-348 50 mg BID, orally up to Week 6. Following Week 6, depending on the participants' safety and Hb concentrations, they could undergo one potential dose-level increase from 50 to 100 mg BID. After completion of the Core Period of 24 weeks, participants were eligible to continue to receive AG-348 in the Extension Period which is up to 10 years.
11380593|NCT03692052|EG000|Reported Event|AG-348|Participants with alpha or beta thalassemia received AG-348 50 mg BID, orally up to Week 6. Following Week 6, depending on the participants' safety and Hb concentrations, they could undergo one potential dose-level increase from 50 to 100 mg BID. After completion of the Core Period of 24 weeks, participants were eligible to continue to receive AG-348 in the Extension Period which is up to 10 years.
11380594|NCT03648476|BG000|Baseline|ICAN|"6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
10782818|NCT02577354|OG001|Outcome|Control|ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782819|NCT02577354|OG000|Outcome|Treatment|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782820|NCT02577354|OG001|Outcome|Control/Crossover|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After the 120-day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
10782821|NCT02577354|OG002|Outcome|All (Treatment and Control/Crossover Combined)|At the 1-year visit, all participants are receiving patient-appropriate therapy (1 year of patient-appropriated therapy for the Treatment Group, and 8 months of patient-appropriate therapy for the Control Group). This column provides the results for all participants in one group.
10782822|NCT02577354|OG002|Outcome|All (Treatment and Control/Crossover Combined)|At the 1-year visit, all participants are receiving patient-appropriate therapy (1 year of patient-appropriated therapy for the Treatment Group, and 8 months of patient-appropriate therapy for the Control/Crossover Group). This column provides the results for all participants in one group.
11193951|NCT02149173|OG001|Outcome|Qualitative Uptake|Number of lesions visually indicated as having FES uptake
11193952|NCT02149173|OG000|Outcome|FES With Potential ER Modulating Therapy (Vorinostat)|Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between 1-12 weeks after starting possible ER modulating therapy (vorinostat) and then 1-12 weeks after the second FES PET/CT scan.
11193953|NCT02149173|OG001|Outcome|FES With Potential ER Blocking Therapy|Patients undergo F-18 FES PET/CT scan and FDG PET/CT at baseline. Patients also undergo F-18 FES PET/CT between 1-12 weeks after starting possible ER blocking therapy.
10964592|NCT00878215|EG001|Reported Event|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
10964593|NCT00878215|EG002|Reported Event|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
10964594|NCT00878215|EG003|Reported Event|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
10964595|NCT00878228|BG000|Baseline|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
10964596|NCT00878228|BG001|Baseline|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
10964597|NCT00878228|BG002|Baseline|Total|Total of all reporting groups
10964598|NCT00878228|FG000|Participant Flow|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
10782823|NCT02577354|OG000|Outcome|Treatment|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782824|NCT02577354|OG001|Outcome|Control/Crossover|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
10782825|NCT02577354|OG002|Outcome|All (Treatment and Control/Crossover Combined)|At the 1 Year visit, all participants are receiving patient-appropriate therapy (1 year of patient-appropriated therapy for the Treatment Group, and 8 months of patient-appropriate therapy for the Control/Crossover Group). This column provides the results for all participants in one group.
11193954|NCT02149173|EG000|Reported Event|Diagnostic (F-18 FES PET/CT)|Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan.
10782826|NCT02577354|OG000|Outcome|All Participants Combined|At the 1-year visit, all participants are receiving patient-appropriate therapy (1 year of patient-appropriate therapy for the Treatment Group, and 8 months of patient-appropriate therapy for the Control Group).
10782827|NCT02577354|EG000|Reported Event|Treatment -- Blinded Phase (0-120 Days)|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782828|NCT02577354|EG001|Reported Event|Control -- Blinded Phase (0-120 Days)|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
10782829|NCT02577354|EG002|Reported Event|Treatment -- Open Label Phase (121-365 Days)|ReActiv8 Implantable Stimulation System (patient appropriate stimulation): ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level and participants instructed to deliver stimulation in two 30-minute sessions per day.
10782830|NCT02577354|EG003|Reported Event|Crossover -- Open Label Phase (121-365 Days)|"ReActiv8 Implantable Stimulation System (low stimulation): ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.~After 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level."
11193955|NCT02149199|BG000|Baseline|Placebo Bid + Symbicort 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
11193956|NCT02149199|BG001|Baseline|Placebo Bid + Terbutaline 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193957|NCT02149199|BG002|Baseline|Pulmicort Bid + Terbutaline 'as Needed'|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193958|NCT02149199|BG003|Baseline|Total|Total of all reporting groups
11193959|NCT02149199|FG000|Participant Flow|Placebo Bid + Symbicort 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
11193960|NCT02149199|FG001|Participant Flow|Placebo Bid + Terbutaline 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193961|NCT02149199|FG002|Participant Flow|Pulmicort Bid + Terbutaline 'as Needed'|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193962|NCT02149199|OG000|Outcome|Placebo Bid + Symbicort 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
11193963|NCT02149199|OG001|Outcome|Placebo Bid + Terbutaline 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
10801684|NCT03529773|EG025|Reported Event|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
11193964|NCT02149199|OG002|Outcome|Pulmicort Bid + Terbutaline 'as Needed'|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193965|NCT02149199|EG000|Reported Event|Placebo Bid + Symbicort 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
10803742|NCT02134028|BG000|Baseline|Participants From DRI12544: Placebo/Dupilumab|Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11193966|NCT02149199|EG001|Reported Event|Placebo Bid + Terbutaline 'as Needed'|Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193967|NCT02149199|EG002|Reported Event|Pulmicort Bid + Terbutaline 'as Needed'|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
11193968|NCT02149264|BG000|Baseline|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
11193969|NCT02149264|FG000|Participant Flow|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
11193970|NCT02149264|OG000|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
11193971|NCT02149264|EG000|Reported Event|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
11193972|NCT02149290|BG000|Baseline|Trends-equipped LifeVest 4000|"Subjects using the LifeVest 4000 modified to collect Trends data~Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test"
11193973|NCT02149290|FG000|Participant Flow|Trends-equipped LifeVest 4000|"Subjects using the LifeVest 4000 modified to collect Trends data~Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test"
11193974|NCT02149290|OG000|Outcome|Clinician Guided 6MWT|Distance-First Clinician guided 6MWT
11193975|NCT02149290|OG001|Outcome|WCD Guided 6MWT|Distance-First WCD guided 6MWT
11193976|NCT02149290|OG000|Outcome|Trends-equipped LifeVest 4000|"Subjects using the LifeVest 4000 modified to collect Trends data~Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test"
11193977|NCT02149290|EG000|Reported Event|Trends-equipped LifeVest 4000|"Subjects using the LifeVest 4000 modified to collect Trends data~Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test"
10782835|NCT02471807|BG000|Baseline|Edwards FORMA Tricuspid Transcatheter Repair System|"Edwards FORMA Tricuspid Transcatheter Repair System~Edwards FORMA Tricuspid Transcatheter Repair System"
10782836|NCT02471807|FG000|Participant Flow|Edwards FORMA Tricuspid Transcatheter Repair System|"Edwards FORMA Tricuspid Transcatheter Repair System~Edwards FORMA Tricuspid Transcatheter Repair System"
10782837|NCT02471807|OG000|Outcome|Edwards FORMA Tricuspid Transcatheter Repair System|Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
10782838|NCT02471807|EG000|Reported Event|Edwards FORMA Tricuspid Transcatheter Repair System|"Edwards FORMA Tricuspid Transcatheter Repair System~Edwards FORMA Tricuspid Transcatheter Repair System"
10782839|NCT02321514|BG000|Baseline|Tendyne Mitral Valve System|"Tendyne Mitral Valve System~Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system"
11380595|NCT03648476|BG001|Baseline|WLC: Waitlist Control|"WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
10782840|NCT02321514|FG000|Participant Flow|Tendyne Mitral Valve System|"Tendyne Mitral Valve System~Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system"
10782841|NCT02321514|OG000|Outcome|Tendyne Mitral Valve System|"Tendyne Mitral Valve System~Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system"
10782842|NCT02321514|EG000|Reported Event|Tendyne Mitral Valve System|"Tendyne Mitral Valve System~Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system"
10782843|NCT02118610|BG000|Baseline|L-tetrahydropalmatine|"l-tetrahydropalmatine (30 mg BID)~L-tetrahydropalmatine (30mg): Active comparator"
10782844|NCT02118610|BG001|Baseline|Sugar Pill|Sugar pill: Placebo
10782845|NCT02118610|BG002|Baseline|Total|Total of all reporting groups
10782846|NCT02118610|FG000|Participant Flow|L-tetrahydropalmatine|"l-tetrahydropalmatine (30 mg BID)~L-tetrahydropalmatine (30mg): Active comparator"
10782847|NCT02118610|FG001|Participant Flow|Sugar Pill|Sugar pill: Placebo
10782848|NCT02118610|OG000|Outcome|L-tetrahydropalmatine|"l-tetrahydropalmatine (30 mg BID)~L-tetrahydropalmatine (30mg): Active comparator"
10782849|NCT02118610|OG001|Outcome|Sugar Pill|Sugar pill: Placebo
10782850|NCT02118610|EG000|Reported Event|L-tetrahydropalmatine|"l-tetrahydropalmatine (30 mg BID)~L-tetrahydropalmatine (30mg): Active comparator"
10782851|NCT02118610|EG001|Reported Event|Sugar Pill|Sugar pill: Placebo
11380596|NCT03648476|BG002|Baseline|Total|Total of all reporting groups
10801685|NCT03529773|EG026|Reported Event|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801686|NCT03529773|EG027|Reported Event|Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801687|NCT03529773|EG028|Reported Event|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801688|NCT03529773|EG029|Reported Event|Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801689|NCT03529773|EG030|Reported Event|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801690|NCT03529773|EG031|Reported Event|Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3
10801691|NCT03529773|EG032|Reported Event|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years|Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801692|NCT03529773|EG033|Reported Event|Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801693|NCT03529773|EG034|Reported Event|Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801694|NCT03529773|EG035|Reported Event|Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:|Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801695|NCT03529773|EG036|Reported Event|Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
10801696|NCT03529773|EG037|Reported Event|Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10964599|NCT00878228|FG001|Participant Flow|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
10782852|NCT01909570|BG000|Baseline|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
10782853|NCT01909570|BG001|Baseline|Double Embryo Transfer|Transfer of two fresh embryos
10782854|NCT01909570|BG002|Baseline|Total|Total of all reporting groups
10782855|NCT01909570|FG000|Participant Flow|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
10782856|NCT01909570|FG001|Participant Flow|Double Embryo Transfer|Transfer of two fresh embryos
10782857|NCT01909570|OG000|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
10782858|NCT01909570|OG001|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
10782859|NCT01909570|EG000|Reported Event|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
10782860|NCT01909570|EG001|Reported Event|Double Embryo Transfer|Transfer of two fresh embryos
11380597|NCT03648476|FG000|Participant Flow|ICAN|"6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
10782861|NCT01453946|BG000|Baseline|Entocort|Entocort 6 mg/day
10782862|NCT01453946|FG000|Participant Flow|Entocort|Entocort 6 mg/day
10782863|NCT01453946|OG000|Outcome|Entocort|Entocort 6 mg/day
10782864|NCT01453946|EG000|Reported Event|Entocort|Entocort 6 mg/day
10782865|NCT01444092|BG000|Baseline|Entocort|Entocort™ EC 9/6/3 mg
10782866|NCT01444092|FG000|Participant Flow|Entocort|Entocort™ EC 9/6/3 mg
10782867|NCT01444092|OG000|Outcome|Entocort|Entocort™ EC 9/6/3 mg
10782868|NCT01444092|EG000|Reported Event|Entocort|Entocort™ EC 9/6/3 mg
10782869|NCT01265784|BG000|Baseline|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782870|NCT01265784|BG001|Baseline|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782871|NCT01265784|BG002|Baseline|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782872|NCT01265784|BG003|Baseline|Total|Total of all reporting groups
10782873|NCT01265784|FG000|Participant Flow|TP-434, 1.5 mg/kg q24h|TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782874|NCT01265784|FG001|Participant Flow|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782875|NCT01265784|FG002|Participant Flow|Ertapenem, 1 g q24h|Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782876|NCT01265784|OG000|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782877|NCT01265784|OG001|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782878|NCT01265784|OG002|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782879|NCT01265784|EG000|Reported Event|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782880|NCT01265784|EG001|Reported Event|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782881|NCT01265784|EG002|Reported Event|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
10782882|NCT00577577|BG000|Baseline|IPLEX™|Participants received 1.0 mg/kg IPLEX™ (rhIGF-I/rhIGFBP-3) via a subcutaneous injection once a day for 24 weeks.
10782883|NCT00577577|BG001|Baseline|Placebo|Participants received a matching placebo to IPLEX™ once a day via a subcutaneous injection for 24 weeks.
10782884|NCT00577577|BG002|Baseline|Total|Total of all reporting groups
10782885|NCT00577577|FG000|Participant Flow|IPLEX™|Participants received 1.0 mg/kg IPLEX™ (rhIGF-I/rhIGFBP-3) via a subcutaneous injection once a day for 24 weeks.
10782886|NCT00577577|FG001|Participant Flow|Placebo|Participants received a matching placebo to IPLEX™ once a day via a subcutaneous injection for 24 weeks.
10782887|NCT00577577|OG000|Outcome|IPLEX™|Participants received 1.0 mg/kg IPLEX™ (rhIGF-I/rhIGFBP-3) via a subcutaneous injection once a day for 24 weeks.
10782888|NCT00577577|OG001|Outcome|Placebo|Participants received a matching placebo to IPLEX™ once a day via a subcutaneous injection for 24 weeks.
10782889|NCT00577577|EG000|Reported Event|IPLEX™|Participants received 1.0 mg/kg IPLEX™ (rhIGF-I/rhIGFBP-3) via a subcutaneous injection once a day for 24 weeks.
10782890|NCT00577577|EG001|Reported Event|Placebo|Participants received a matching placebo to IPLEX™ once a day via a subcutaneous injection for 24 weeks.
10782891|NCT00392327|BG000|Baseline|Regimen A (Medulloblastoma Patients)|Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
10782892|NCT00392327|BG001|Baseline|Regimen B (Medulloblastoma Patients)|Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
10782893|NCT00392327|BG002|Baseline|Regimen C (Medulloblastoma Patients)|Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
10782894|NCT00392327|BG003|Baseline|Regimen D (Medulloblastoma Patients)|Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
10782895|NCT00392327|BG004|Baseline|Regimen A (SPNET Patients)|SPNET patients who received regimen A (no carboplatin / no isotretinoin)
10782896|NCT00392327|BG005|Baseline|Regimen B (SPNET Patients)|SPNET patients who received regimen B (carboplatin / no isotretinoin)
10782897|NCT00392327|BG006|Baseline|Regimen C (SPNET Patients)|SPNET patients who received regimen C (no carboplatin / isotretinoin)
10782898|NCT00392327|BG007|Baseline|Regimen D (SPNET Patients)|SPNET patients who received regimen D (carboplatin / isotretinoin)
10782899|NCT00392327|BG008|Baseline|Total|Total of all reporting groups
10782900|NCT00392327|FG000|Participant Flow|Regimen A (Medulloblastoma Patients)|Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
10782901|NCT00392327|FG001|Participant Flow|Regimen B (Medulloblastoma Patients)|Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
10782902|NCT00392327|FG002|Participant Flow|Regimen C (Medulloblastoma Patients)|Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
10782903|NCT00392327|FG003|Participant Flow|Regimen D (Medulloblastoma Patients)|Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
10782904|NCT00392327|FG004|Participant Flow|Regimen A (SPNET Patients)|SPNET patients who received regimen A (no carboplatin / no isotretinoin)
10782905|NCT00392327|FG005|Participant Flow|Regimen B (SPNET Patients)|SPNET patients who received regimen B (carboplatin / no isotretinoin)
10782906|NCT00392327|FG006|Participant Flow|Regimen C (SPNET Patients)|SPNET patients who received regimen C (no carboplatin / isotretinoin)
10782907|NCT00392327|FG007|Participant Flow|Regimen D (SPNET Patients)|SPNET patients who received regimen D (carboplatin / isotretinoin)
10782908|NCT00392327|OG000|Outcome|Regimen A (Medulloblastoma Patients)|Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
10782909|NCT00392327|OG001|Outcome|Regimen B (Medulloblastoma Patients)|Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
10782910|NCT00392327|OG002|Outcome|Regimen C (Medulloblastoma Patients)|Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
10782911|NCT00392327|OG003|Outcome|Regimen D (Medulloblastoma Patients)|Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
10782912|NCT00392327|OG000|Outcome|Regimen A (SPNET Patients)|SPNET patients who received regimen A (no carboplatin / no isotretinoin)
10782913|NCT00392327|OG001|Outcome|Regimen B (SPNET Patients)|SPNET patients who received regimen B (carboplatin / no isotretinoin)
10782914|NCT00392327|OG002|Outcome|Regimen C (SPNET Patients)|SPNET patients who received regimen C (no carboplatin / isotretinoin)
10782915|NCT00392327|OG003|Outcome|Regimen D (SPNET Patients)|SPNET patients who received regimen D (carboplatin / isotretinoin)
10782916|NCT00392327|EG000|Reported Event|Regimen A (Medulloblastoma Patients)|Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
10782917|NCT00392327|EG001|Reported Event|Regimen B (Medulloblastoma Patients)|Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
10782918|NCT00392327|EG002|Reported Event|Regimen C (Medulloblastoma Patients)|Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
10782919|NCT00392327|EG003|Reported Event|Regimen D (Medulloblastoma Patients)|Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
10782920|NCT00392327|EG004|Reported Event|Regimen A (SPNET Patients)|SPNET patients who received regimen A (no carboplatin / no isotretinoin)
10782921|NCT00392327|EG005|Reported Event|Regimen B (SPNET Patients)|SPNET patients who received regimen B (carboplatin / no isotretinoin)
10782922|NCT00392327|EG006|Reported Event|Regimen C (SPNET Patients)|SPNET patients who received regimen C (no carboplatin / isotretinoin)
10782923|NCT00392327|EG007|Reported Event|Regimen D (SPNET Patients)|SPNET patients who received regimen D (carboplatin / isotretinoin)
10782924|NCT00085202|BG000|Baseline|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
10782925|NCT00085202|BG001|Baseline|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
10782926|NCT00085202|BG002|Baseline|Total|Total of all reporting groups
10782927|NCT00085202|FG000|Participant Flow|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
10782928|NCT00085202|FG001|Participant Flow|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
10782929|NCT00085202|OG000|Outcome|Overall Study|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
10782930|NCT00085202|OG001|Outcome|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
10782931|NCT00085202|OG002|Outcome|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
10782932|NCT00085202|OG000|Outcome|ERBB2 Positive & Average Risk|54 participants who were ERBB2 positive and in the average risk group.
10782933|NCT00085202|OG001|Outcome|ERBB2 Positive & High Risk|23 participants who were ERBB2 positive and in the high risk group
10782934|NCT00085202|OG002|Outcome|ERBB2 Negative & Average Risk|31 participants who were ERBB2 negative and in the average risk group
10782935|NCT00085202|OG003|Outcome|ERBB2 Negative & High Risk|14 participants who were ERBB2 negative and in the high risk group
10782936|NCT00085202|OG000|Outcome|SHH Pathway - In/Del Somatic|Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
10782937|NCT00085202|OG001|Outcome|WNT Pathway - In/Del Somatic|Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
10782938|NCT00085202|OG002|Outcome|SHH Pathway - In/Del Germline|Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
10782939|NCT00085202|OG003|Outcome|WNT Pathway - In/Del Germline|Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
10782940|NCT00085202|OG004|Outcome|SHH Pathway - SNV Somatic|Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).
10782941|NCT00085202|OG005|Outcome|WNT Pathway - SNV Somatic|Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).
10782942|NCT00085202|OG006|Outcome|SHH Pathway - SNV Germline|Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).
10782943|NCT00085202|OG007|Outcome|WNT Pathway - SNV Germline|Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).
10782944|NCT00085202|EG000|Reported Event|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
10782945|NCT00085202|EG001|Reported Event|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
10801697|NCT03529773|EG038|Reported Event|Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years|Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801698|NCT03529773|EG039|Reported Event|Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years|Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
10801699|NCT03502070|BG000|Baseline|Open-Label Placebo|"One dose (4 capsules) of placebo~Placebo: One dose (4 capsules) of placebo~Tobi Podhaler: The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use"
10801700|NCT03502070|FG000|Participant Flow|Open-Label Placebo|"One dose (4 capsules) of placebo~Placebo: One dose (4 capsules) of placebo~Tobi Podhaler: The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use"
10801701|NCT03502070|OG000|Outcome|Open-Label Placebo|"One dose (4 capsules) of placebo~Placebo: One dose (4 capsules) of placebo~Tobi Podhaler: The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use"
10801702|NCT03502070|EG000|Reported Event|Open-Label Placebo|"One dose (4 capsules) of placebo~Placebo: One dose (4 capsules) of placebo~Tobi Podhaler: The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use"
10801703|NCT03485911|BG000|Baseline|Berotralstat 110 mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
10801704|NCT03485911|BG001|Baseline|Berotralstat 150 mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
10801705|NCT03485911|BG002|Baseline|Placebo|Placebo administered as two 2 matching capsules, orally QD for 24 weeks.
10801706|NCT03485911|BG003|Baseline|Total|Total of all reporting groups
10801707|NCT03485911|FG000|Participant Flow|Berotralstat 110 mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
10801708|NCT03485911|FG001|Participant Flow|Berotralstat 150 mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
10801709|NCT03485911|FG002|Participant Flow|Placebo|Placebo administered as two 2 matching capsules, orally QD for 24 weeks.
10801710|NCT03485911|OG000|Outcome|Berotralstat 110 mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
10801711|NCT03485911|OG001|Outcome|Berotralstat 150 mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
10801712|NCT03485911|OG002|Outcome|Placebo|Placebo administered as two 2 matching capsules, orally QD for 24 weeks.
10801713|NCT03485911|EG000|Reported Event|Berotralstat 110 mg Once Daily|Berotralstat administered as two 55mg capsules, orally QD for 24 weeks.
10801714|NCT03485911|EG001|Reported Event|Berotralstat 150 mg Once Daily|Berotralstat administered as two 75mg capsules, orally QD for 24 weeks.
10801715|NCT03485911|EG002|Reported Event|Placebo|Placebo administered as two 2 matching capsules, orally QD for 24 weeks.
10964600|NCT00878228|OG000|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
10964601|NCT00878228|OG001|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
11193978|NCT02149303|BG000|Baseline|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
11193979|NCT02149303|FG000|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
11193980|NCT02149303|OG000|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
11193981|NCT02149303|EG000|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
11193982|NCT02149342|BG000|Baseline|Hexylaminolaevulinate and Methylaminoalevulinate Cream|0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
11193983|NCT02149342|FG000|Participant Flow|Hexylaminolaevulinate and Methylaminoalevulinate Creams|"0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma)~HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design"
11193984|NCT02149342|OG000|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream"
11193985|NCT02149342|OG001|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
11193986|NCT02149342|OG000|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
11193987|NCT02149342|EG000|Reported Event|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
11193988|NCT02149342|EG001|Reported Event|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
11193989|NCT02149420|BG000|Baseline|Placebo|single dose iv of Placebo
11193990|NCT02149420|BG001|Baseline|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11193991|NCT02149420|BG002|Baseline|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg
11193992|NCT02149420|BG003|Baseline|Total|Total of all reporting groups
11193993|NCT02149420|FG000|Participant Flow|Placebo|single dose iv of Placebo (+ Option to receive Open label VAY736 10 mg/kg at Week 24)
11193994|NCT02149420|FG001|Participant Flow|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11193995|NCT02149420|FG002|Participant Flow|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg
11193996|NCT02149420|OG000|Outcome|Placebo|single dose iv of Placebo
11193997|NCT02149420|OG001|Outcome|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11193998|NCT02149420|OG002|Outcome|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg
11193999|NCT02149420|OG003|Outcome|VAY736 Combined|Combining VAY736 3mg/kg and VAY736 10mg/kg
11194000|NCT02149420|OG000|Outcome|VAY736 3 mg/kg|single dose iv of VAY736 at a dose of 3mg/kg
11194001|NCT02149420|OG001|Outcome|VAY736 10 mg/kg|single dose iv of VAY736 at a dose of 10mg/kg
11194002|NCT02149420|OG002|Outcome|Open Label VAY736|Open label VAY736 10mg/kg
11194003|NCT02149420|EG000|Reported Event|Placebo|Placebo
11194004|NCT02149420|EG001|Reported Event|VAY736 3mg/kg|VAY736 3mg/kg
11194005|NCT02149420|EG002|Reported Event|VAY736 10mg/kg|VAY736 10mg/kg
11194006|NCT02149420|EG003|Reported Event|Open Label VAY736 10mg/kg|Open label VAY736 10mg/kg
11194007|NCT02149524|BG000|Baseline|Herceptin (Trastuzumab)|"Intravenous administration~Herceptin (trastuzuamb): Intravenous administration"
11194008|NCT02149524|BG001|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"Intravenous administration~SB3 (proposed trastuzumab biosimilar): Intravenous administration"
11194009|NCT02149524|BG002|Baseline|Total|Total of all reporting groups
11194010|NCT02149524|FG000|Participant Flow|Herceptin (Trastuzumab)|"Intravenous administration~Herceptin (trastuzuamb): Intravenous administration"
11194011|NCT02149524|FG001|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"Intravenous administration~SB3 (proposed trastuzumab biosimilar): Intravenous administration"
11194012|NCT02149524|OG000|Outcome|Herceptin (Trastuzumab)|"Intravenous administration~Herceptin (trastuzuamb): Intravenous administration"
11194013|NCT02149524|OG001|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"Intravenous administration~SB3 (proposed trastuzumab biosimilar): Intravenous administration"
11194014|NCT02149524|EG000|Reported Event|Herceptin (Trastuzumab)|"Intravenous administration~Herceptin (trastuzuamb): Intravenous administration"
11194015|NCT02149524|EG001|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"Intravenous administration~SB3 (proposed trastuzumab biosimilar): Intravenous administration"
11194016|NCT02149810|BG000|Baseline|Automatic Self Transcending Meditation and Treatment as Usual|Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minutes sessions each of four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
11194017|NCT02149810|BG001|Baseline|Treatment as Usual|Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
11194018|NCT02149810|BG002|Baseline|Total|Total of all reporting groups
11194019|NCT02149810|FG000|Participant Flow|Automatic Self Transcending Meditation and Treatment as Usual|Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
11194020|NCT02149810|FG001|Participant Flow|Treatment as Usual|Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
11194021|NCT02149810|OG000|Outcome|Automatic Self Transcending Meditation and Treatment as Usual|Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
11194022|NCT02149810|OG001|Outcome|Treatment as Usual|Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
11194023|NCT02149810|EG000|Reported Event|Automatic Self Transcending Meditation and Treatment as Usual|Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
11380598|NCT03648476|FG001|Participant Flow|WLC: Waitlist Control|"WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
11380599|NCT03648476|OG000|Outcome|ICAN|"6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
11380600|NCT03648476|OG001|Outcome|WLC: Waitlist Control|"WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
11380601|NCT03648476|OG001|Outcome|WLC (Post-intervention)|"WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.~After wait period, participants in the WLC receive the ICAN treatment.~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
11380602|NCT03648476|EG000|Reported Event|ICAN|"6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing~ICAN: A 6-week group therapy sessions once a week for 90-120 minutes."
11380603|NCT03648476|EG001|Reported Event|WLC: Waitlist Control|WLC participants do not receive treatment until after time two testing 8-weeks from time one testing.
10782950|NCT04739735|BG000|Baseline|Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)|"CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth.~Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
11194024|NCT02149810|EG001|Reported Event|Treatment as Usual|Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
11194025|NCT02149836|BG000|Baseline|Ezogabine|Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
11194026|NCT02149836|FG000|Participant Flow|Ezogabine|Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
11194027|NCT02149836|OG000|Outcome|Ezogabine|Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
11194028|NCT02149836|EG000|Reported Event|Ezogabine|Ezogabine dosage plan starts at 100mg 3x/day and increased to 300mg 3x/day and then tapered down to discontinue for the end of the study.
11194029|NCT02149875|BG000|Baseline|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
11194030|NCT02149875|BG001|Baseline|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
11194031|NCT02149875|BG002|Baseline|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
11380604|NCT03375203|BG000|Baseline|Placebo|Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380605|NCT03375203|BG001|Baseline|JNJ-42847922 5 mg|Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380606|NCT03375203|BG002|Baseline|JNJ-42847922 10 mg|Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380607|NCT03375203|BG003|Baseline|JNJ-42847922 20 mg|Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380608|NCT03375203|BG004|Baseline|Zolpidem|Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380609|NCT03375203|BG005|Baseline|Total|Total of all reporting groups
11380610|NCT03375203|FG000|Participant Flow|Placebo|Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380611|NCT03375203|FG001|Participant Flow|JNJ-42847922 5 mg|Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380612|NCT03375203|FG002|Participant Flow|JNJ-42847922 10 mg|Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380613|NCT03375203|FG003|Participant Flow|JNJ-42847922 20 mg|Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380614|NCT03375203|FG004|Participant Flow|Zolpidem|Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380615|NCT03375203|OG000|Outcome|Placebo|Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
10801716|NCT03403634|BG000|Baseline|Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)|"Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.~Celecoxib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Alfa-2b: Given IV~Rintatolimod: Given IV"
11380616|NCT03375203|OG001|Outcome|JNJ-42847922 5 mg|Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380617|NCT03375203|OG002|Outcome|JNJ-42847922 10 mg|Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380618|NCT03375203|OG003|Outcome|JNJ-42847922 20 mg|Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380619|NCT03375203|OG004|Outcome|Zolpidem|Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380620|NCT03375203|OG000|Outcome|Placebo|Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14
11380621|NCT03375203|EG000|Reported Event|Placebo|Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380622|NCT03375203|EG001|Reported Event|JNJ-42847922 5 mg|Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380623|NCT03375203|EG002|Reported Event|JNJ-42847922 10 mg|Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380624|NCT03375203|EG003|Reported Event|JNJ-42847922 20 mg|Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
11380625|NCT03375203|EG004|Reported Event|Zolpidem|Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
11380626|NCT02926833|BG000|Baseline|Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
11380627|NCT02926833|BG001|Baseline|Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
11380628|NCT02926833|BG002|Baseline|Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380629|NCT02926833|BG003|Baseline|Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380630|NCT02926833|BG004|Baseline|Total|Total of all reporting groups
11380631|NCT02926833|FG000|Participant Flow|Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
10782946|NCT05007639|BG000|Baseline|Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program|"All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2007 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included. Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas were not included. Patients being treated for recurrence, and patients diagnosed outside of the administrative districts were not eligible. STS diagnoses were made in public or private pathology laboratories. Data were collected from all relevant sources: pathology reports, medical records from private and public centers,~Public Health intervention programme: The public health intervention programme combined 3 actions : a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).~No public Health intervention programme"
10782947|NCT05007639|FG000|Participant Flow|Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program|"All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2007 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included. Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas were not included. Patients being treated for recurrence, and patients diagnosed outside of the administrative districts were not eligible. STS diagnoses were made in public or private pathology laboratories. Data were collected from all relevant sources: pathology reports, medical records from private and public centers,~Public Health intervention programme: The public health intervention programme combined 3 actions : a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).~No public Health intervention programme"
10782948|NCT05007639|OG000|Outcome|Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program|"All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2007 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included. Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas were not included. Patients being treated for recurrence, and patients diagnosed outside of the administrative districts were not eligible. STS diagnoses were made in public or private pathology laboratories. Data were collected from all relevant sources: pathology reports, medical records from private and public centers,~Public Health intervention programme: The public health intervention programme combined 3 actions : a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).~No public Health intervention programme"
10782949|NCT05007639|EG000|Reported Event|Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program|"All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2007 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included. Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas were not included. Patients being treated for recurrence, and patients diagnosed outside of the administrative districts were not eligible. STS diagnoses were made in public or private pathology laboratories. Data were collected from all relevant sources: pathology reports, medical records from private and public centers,~Public Health intervention programme: The public health intervention programme combined 3 actions : a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).~No public Health intervention programme"
10782951|NCT04739735|BG001|Baseline|Conventional Injection of Inferior Alveolar Nerve Block|"In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva.~A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met.~Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10782952|NCT04739735|BG002|Baseline|Total|Total of all reporting groups
10782953|NCT04739735|FG000|Participant Flow|Computer Controlled -Intraligamentary Anesthesia (CC-ILA)|"CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth.~Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10803743|NCT02134028|BG001|Baseline|Participants From DRI12544: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11380632|NCT02926833|FG001|Participant Flow|Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
11380633|NCT02926833|FG002|Participant Flow|Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380634|NCT02926833|FG003|Participant Flow|Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380635|NCT02926833|OG000|Outcome|Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
11380636|NCT02926833|OG001|Outcome|Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
11380637|NCT02926833|OG002|Outcome|Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380638|NCT02926833|OG000|Outcome|Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380639|NCT02926833|OG003|Outcome|Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380640|NCT02926833|EG000|Reported Event|Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
11380641|NCT02926833|EG001|Reported Event|Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
11380642|NCT02926833|EG002|Reported Event|Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
10801717|NCT03403634|FG000|Participant Flow|Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)|"Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.~Celecoxib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Alfa-2b: Given IV~Rintatolimod: Given IV"
10801718|NCT03403634|OG000|Outcome|Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)|"Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.~Celecoxib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Alfa-2b: Given IV~Rintatolimod: Given IV"
11380643|NCT02926833|EG003|Reported Event|Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)|Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
11380644|NCT02899299|BG000|Baseline|Treatment A|Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
11380645|NCT02899299|BG001|Baseline|Treatment B|Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles
11380646|NCT02899299|BG002|Baseline|Total|Total of all reporting groups
11380647|NCT02899299|FG000|Participant Flow|Treatment A|Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
11380648|NCT02899299|FG001|Participant Flow|Treatment B|Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles
11380649|NCT02899299|OG000|Outcome|Treatment A|Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
11380650|NCT02899299|OG001|Outcome|Treatment B|Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles
11380651|NCT02899299|EG000|Reported Event|Treatment A|Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
11380652|NCT02899299|EG001|Reported Event|Treatment B|Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles
11380653|NCT02879448|BG000|Baseline|Amulet|"Amulet left atrial appendage occluder~Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure"
10782954|NCT04739735|FG001|Participant Flow|Conventional Injection of Inferior Alveolar Nerve Block|"In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva.~A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met.~Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10782955|NCT04739735|OG000|Outcome|Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)|"CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth.~Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10782956|NCT04739735|OG001|Outcome|Conventional Injection of Inferior Alveolar Nerve Block|"In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva.~A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met.~Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10782957|NCT04739735|EG000|Reported Event|Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)|"CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth.~Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10782958|NCT04739735|EG001|Reported Event|Conventional Injection of Inferior Alveolar Nerve Block|"In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva.~A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met.~Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.~Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously"
10801719|NCT03403634|EG000|Reported Event|Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)|"Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.~Celecoxib: Given PO~Laboratory Biomarker Analysis: Correlative studies~Recombinant Interferon Alfa-2b: Given IV~Rintatolimod: Given IV"
10801720|NCT03382041|BG000|Baseline|Carbon Fiber Implant|"There is an alternative to the standard treatment, which is carbon fiber implants (tibial nails), especially in the prophylactic reinforcement of bones susceptible to pathological fractures following metastatic tumors. The new carbon fiber has also been used in the treatment of tibial non-union (non- healing bone); which has shown satisfactory outcomes.~Carbon Fiber Implant: A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker."
10801721|NCT03382041|BG001|Baseline|Titanium Implant|"The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants.~Titanium Implant: An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body"
10801722|NCT03382041|BG002|Baseline|Total|Total of all reporting groups
10850628|NCT00303667|FG000|Participant Flow|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
11194032|NCT02149875|BG003|Baseline|Total|Total of all reporting groups
11194033|NCT02149875|FG000|Participant Flow|Dl-3-n-butylphthalide|"Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
11194034|NCT02149875|FG001|Participant Flow|Cerebrolysin|"Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
11194035|NCT02149875|FG002|Participant Flow|Placebo|"Intravenous infusion of 100 ml saline intravenous q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
10782959|NCT04552535|BG000|Baseline|Second-line Afatinib Treatment Group|Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782960|NCT04552535|BG001|Baseline|Second-line Chemotherapy Treatment Group|Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection.
10782961|NCT04552535|BG002|Baseline|Total|Total of all reporting groups
10782962|NCT04552535|FG000|Participant Flow|Second-line Afatinib Treatment Group|Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782963|NCT04552535|FG001|Participant Flow|Second-line Chemotherapy Treatment Group|Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection.
10782964|NCT04552535|OG000|Outcome|Second-line Afatinib Treatment Group|Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782965|NCT04552535|OG001|Outcome|Second-line Chemotherapy Treatment Group|Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection.
10782966|NCT04552535|OG000|Outcome|Second-line Afatinib Treatment Group With Squamous Cell Histology|Patients in the second-line afatinib treatment group with squamous cell histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with squamous cell histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782967|NCT04552535|OG001|Outcome|Second-line Afatinib Treatment Group With Mixed Histology|Patients in the second-line afatinib treatment group with mixed histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with mixed histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782968|NCT04552535|OG000|Outcome|Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status|Patients in the second-line afatinib treatment group with EGFR mutation positive status initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with EGFR mutation positive status had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782969|NCT04552535|OG001|Outcome|Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status|Patients in the second-line afatinib treatment group with Epidermal growth factor receptor (EGFR) mutation negative status initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with EGFR mutation negative status had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10782970|NCT04552535|EG000|Reported Event|Second-line Afatinib Treatment Group|Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection.
10801723|NCT03382041|FG000|Participant Flow|Carbon Fiber Implant|"There is an alternative to the standard treatment, which is carbon fiber implants (tibial nails), especially in the prophylactic reinforcement of bones susceptible to pathological fractures following metastatic tumors. The new carbon fiber has also been used in the treatment of tibial non-union (non- healing bone); which has shown satisfactory outcomes.~Carbon Fiber Implant: A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker."
10801724|NCT03382041|FG001|Participant Flow|Titanium Implant|"The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants.~Titanium Implant: An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body"
10801725|NCT03382041|OG000|Outcome|Carbon Fiber Implant|"There is an alternative to the standard treatment, which is carbon fiber implants (tibial nails), especially in the prophylactic reinforcement of bones susceptible to pathological fractures following metastatic tumors. The new carbon fiber has also been used in the treatment of tibial non-union (non- healing bone); which has shown satisfactory outcomes.~Carbon Fiber Implant: A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker."
10801726|NCT03382041|OG001|Outcome|Titanium Implant|"The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants.~Titanium Implant: An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body"
10782971|NCT04502472|BG000|Baseline|Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion|"Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria~Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome."
10782972|NCT04502472|BG001|Baseline|Donor of COVID-19 Convalescent Plasma (CCP)|Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab.
10782973|NCT04502472|BG002|Baseline|Total|Total of all reporting groups
10782974|NCT04502472|FG000|Participant Flow|COVID-19 Convalescent Plasma (CCP) Donors|Patients recovered from COVID-19 and donated CCP through the study.
10782975|NCT04502472|FG001|Participant Flow|COVID-19 Convalescent Plasma (CCP Recipients)|Patients who were hospitalized with COVID-19 and received CCP infusions through the study.
10782976|NCT04502472|OG000|Outcome|Patients Hospitalized With COVID-19|45 patients were hospitalized with COVID-19 and received CCP through the study.
10782977|NCT04502472|OG000|Outcome|Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion|"Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria~Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome."
10782978|NCT04502472|OG000|Outcome|Patients Hospitalized With COVID-19|45 patients were analyzed
11194036|NCT02149875|OG000|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
10782979|NCT04502472|OG001|Outcome|Patients Recovered From COVID-19|patients who donated CCP
10782980|NCT04502472|EG000|Reported Event|Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion|"Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria~Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.~Adverse Events only monitored/assessed in Convalescent Plasma Recipients."
10782981|NCT04495166|BG000|Baseline|Motherly App With Brief Psychotherapy|Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782982|NCT04495166|BG001|Baseline|Educational App (Active Control)|Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782983|NCT04495166|BG002|Baseline|Total|Total of all reporting groups
10782984|NCT04495166|FG000|Participant Flow|Motherly App With Brief Psychotherapy|Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782985|NCT04495166|FG001|Participant Flow|Educational App (Active Control)|Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782986|NCT04495166|OG000|Outcome|Motherly App With Brief Psychotherapy|Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782987|NCT04495166|OG001|Outcome|Educational App (Active Control)|Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782988|NCT04495166|EG000|Reported Event|Motherly App With Brief Psychotherapy|Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782989|NCT04495166|EG001|Reported Event|Educational App (Active Control)|Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
10782990|NCT04461483|BG000|Baseline|Part 1, SAD, Cohorts 1 to 3: Placebo|TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
10782991|NCT04461483|BG001|Baseline|Part 1, SAD, Cohort 1: TAK-935 200 mg|TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
10782992|NCT04461483|BG002|Baseline|Part 1, SAD, Cohort 2: TAK-935 600 mg|TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
10782993|NCT04461483|BG003|Baseline|Part 1, SAD, Cohort 3: TAK-935 1200 mg|TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
10782994|NCT04461483|BG004|Baseline|Part 2, MD, Cohort 4: Placebo|TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
10964602|NCT00878228|EG000|Reported Event|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
11194037|NCT02149875|OG001|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
10782995|NCT04461483|BG005|Baseline|Part 2, MD, Cohort 4: TAK-935|TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7, then up-titrated to TAK-935 200 mg, tablets, orally, twice daily, on Days 8 to 14, further up-titrated to TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 as multiple doses with titration in the fasted state.
10782996|NCT04461483|BG006|Baseline|Total|Total of all reporting groups
10782997|NCT04461483|FG000|Participant Flow|Part 1, SAD, Cohorts 1 to 3: Placebo|TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
10782998|NCT04461483|FG001|Participant Flow|Part 1, SAD, Cohort 1: TAK-935 200 mg|TAK-935 200 milligram (mg), tablet, orally, once on Day 1 in fasted state.
10782999|NCT04461483|FG002|Participant Flow|Part 1, SAD, Cohort 2: TAK-935 600 mg|TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
10783000|NCT04461483|FG003|Participant Flow|Part 1, SAD, Cohort 3: TAK-935 1200 mg|TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
10783001|NCT04461483|FG004|Participant Flow|Part 2, MD, Cohort 4: Placebo|TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
10783002|NCT04461483|FG005|Participant Flow|Part 2, MD, Cohort 4: TAK-935|TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7, then up-titrated to TAK-935 200 mg, tablets, orally, twice daily, on Days 8 to 14, further up-titrated to TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 as multiple doses with titration in the fasted state.
11194038|NCT02149875|OG002|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
10783003|NCT04461483|OG000|Outcome|Part 1, SAD, Cohorts 1 to 3: Placebo|TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
10783004|NCT04461483|OG001|Outcome|Part 1, SAD, Cohort 1: TAK-935 200 mg|TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
10783005|NCT04461483|OG002|Outcome|Part 1, SAD, Cohort 2: TAK-935 600 mg|TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
10783006|NCT04461483|OG003|Outcome|Part 1, SAD, Cohort 3: TAK-935 1200 mg|TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
10783007|NCT04461483|OG004|Outcome|Part 2, MD, Cohort 4: Placebo|TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
10783008|NCT04461483|OG005|Outcome|Part 2, MD, Cohort 4: TAK-935 100 mg|TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
10783009|NCT04461483|OG006|Outcome|Part 2, MD, Cohort 4: TAK-935 200 mg|TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
10783010|NCT04461483|OG007|Outcome|Part 2, MD, Cohort 4: TAK-935 300 mg|TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
10783011|NCT04461483|OG000|Outcome|Part 1, SAD, Cohort 1: TAK-935 200 mg|TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
11194039|NCT02149875|EG000|Reported Event|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
11194040|NCT02149875|EG001|Reported Event|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
10783012|NCT04461483|OG001|Outcome|Part 1, SAD, Cohort 2: TAK-935 600 mg|TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
10783013|NCT04461483|OG002|Outcome|Part 1, SAD, Cohort 3: TAK-935 1200 mg|TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
10783014|NCT04461483|OG000|Outcome|Part 2, MD, Cohort 4: TAK-935 100 mg|TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
10783015|NCT04461483|OG001|Outcome|Part 2, MD, Cohort 4: TAK-935 200 mg|TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
10783016|NCT04461483|OG002|Outcome|Part 2, MD, Cohort 4: TAK-935 300 mg|TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
10783017|NCT04461483|EG000|Reported Event|Part 1, SAD, Cohort 1-3: Placebo|TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
10783018|NCT04461483|EG001|Reported Event|Part 1, SAD, Cohort 1: TAK-935 200 mg|TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
10783019|NCT04461483|EG002|Reported Event|Part 1, SAD, Cohort 2: TAK-935 600 mg|TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
10783020|NCT04461483|EG003|Reported Event|Part 1, SAD, Cohort 3: TAK-935 1200 mg|TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
10783021|NCT04461483|EG004|Reported Event|Part 2, MD, Cohort 4: Placebo|TAK-935 placebo-matching tablets, orally, twice daily on Days 1to 21 in fasted state.
10783022|NCT04461483|EG005|Reported Event|Part 2, MD, Cohort 4: TAK-935 100 mg|TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
10783023|NCT04461483|EG006|Reported Event|Part 2, MD, Cohort 4: TAK-935 200 mg|TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
10783024|NCT04461483|EG007|Reported Event|Part 2, MD, Cohort 4: TAK-935 300 mg|TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
10783025|NCT04386616|BG000|Baseline|All Placebo|Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
11194041|NCT02149875|EG002|Reported Event|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
11194042|NCT02150044|BG000|Baseline|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
11194043|NCT02150044|FG000|Participant Flow|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
11194044|NCT02150044|OG000|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
11194045|NCT02150044|EG000|Reported Event|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
10783026|NCT04386616|BG001|Baseline|MSTT1041A|Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783027|NCT04386616|BG002|Baseline|UTTR1147A|Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783028|NCT04386616|BG003|Baseline|Total|Total of all reporting groups
10783029|NCT04386616|FG000|Participant Flow|All Placebo|Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783030|NCT04386616|FG001|Participant Flow|MSTT1041A|Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783031|NCT04386616|FG002|Participant Flow|UTTR1147A|Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783032|NCT04386616|OG000|Outcome|All Placebo|Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783033|NCT04386616|OG001|Outcome|MSTT1041A|Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783034|NCT04386616|OG002|Outcome|UTTR1147A|Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783035|NCT04386616|OG000|Outcome|MSTT1041A-Matched Placebo|Participants in this analysis group received treatment with MSTT1041A-matched placebo. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783036|NCT04386616|OG002|Outcome|UTTR1147A-Matched Placebo|Participants in this analysis group received treatment with UTTR1147A-matched placebo. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783037|NCT04386616|OG003|Outcome|UTTR1147A|Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783038|NCT04386616|OG000|Outcome|UTTR1147A - PK Participants Who Only Received First Dose|All participants in this analysis group only received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783039|NCT04386616|OG001|Outcome|UTTR1147A - PK Participants Who Received Both Doses|All participants in this analysis group received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1 and a second IV dose of UTTR1147A 90 μg/kg on Day 15 because they remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783040|NCT04386616|OG002|Outcome|UTTR1147A - All PK Participants (First Dose Only or Both Doses), Days 1 to 15|Participants in this analysis group either received only the first dose or both doses of UTTR1147A. One intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) was given on Day 1, and a second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783041|NCT04386616|OG000|Outcome|MSTT1041A - PK Participants Who Only Received First Dose|All participants in this analysis group only received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783042|NCT04386616|OG001|Outcome|MSTT1041A - PK Participants Who Received Both Doses|All participants in this analysis group received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1 and a second IV dose of MSTT1041A 350 mg was given on Day 15 because they remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783043|NCT04386616|OG002|Outcome|MSTT1041A - All PK Participants (First Dose Only or Both Doses), Days 1 to 15|Participants in this analysis group either received only the first dose or both doses of MSTT1041A. One intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1, and a second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10964603|NCT00878228|EG001|Reported Event|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
11194046|NCT02150057|BG000|Baseline|Control Group|This group receives no experimental bracing intervention in the study.
10783044|NCT04386616|EG000|Reported Event|All Placebo|Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783045|NCT04386616|EG001|Reported Event|MSTT1041A|Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783046|NCT04386616|EG002|Reported Event|UTTR1147A|Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
10783047|NCT04377711|BG000|Baseline|Group 1|"Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI~Ciclesonide: 160mcg Inhaler"
10783048|NCT04377711|BG001|Baseline|Group 2|"Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI~Placebo: Matching Placebo Inhaler"
10783049|NCT04377711|BG002|Baseline|Total|Total of all reporting groups
10783050|NCT04377711|FG000|Participant Flow|Ciclesonide Arm|"Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI~Ciclesonide: 160mcg Inhaler"
10783051|NCT04377711|FG001|Participant Flow|Placebo Arm|"Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI~Placebo: Matching Placebo Inhaler"
10783052|NCT04377711|OG000|Outcome|Ciclesonide Arm|"Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI~Ciclesonide: 160mcg Inhaler"
10783053|NCT04377711|OG001|Outcome|Placebo Arm|"Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI~Placebo: Matching Placebo Inhaler"
10783054|NCT04377711|EG000|Reported Event|Group 1|"Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI~Ciclesonide: 160mcg Inhaler"
11380654|NCT02879448|BG001|Baseline|WATCHMAN (Control)|"WATCHMAN left atrial appendage closure device~WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure"
10783055|NCT04377711|EG001|Reported Event|Group 2|"Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI~Placebo: Matching Placebo Inhaler"
10783056|NCT04347408|BG000|Baseline|Healthy Children|"Healthy children of healthcare workers between 2 and 15 years of age~Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19"
10783057|NCT04347408|FG000|Participant Flow|Healthy Children|"Healthy children of healthcare workers between 2 and 15 years of age~Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19"
10783058|NCT04347408|OG000|Outcome|Healthy Children|"Healthy children of healthcare workers between 2 and 15 years of age~Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19"
10783059|NCT04347408|EG000|Reported Event|All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.|All-cause mortality, serious and other adverse events were not monitored/assessed.
10801727|NCT03382041|EG000|Reported Event|Carbon Fiber Implant|"There is an alternative to the standard treatment, which is carbon fiber implants (tibial nails), especially in the prophylactic reinforcement of bones susceptible to pathological fractures following metastatic tumors. The new carbon fiber has also been used in the treatment of tibial non-union (non- healing bone); which has shown satisfactory outcomes.~Carbon Fiber Implant: A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker."
10801728|NCT03382041|EG001|Reported Event|Titanium Implant|"The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants.~Titanium Implant: An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body"
10801729|NCT03332095|BG000|Baseline|Cohort 1: DOR|"Participants received a single dose of DOR at study entry (Day 0).~Doravirine (DOR): 100 mg of DOR administered orally~Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study."
10801730|NCT03332095|BG001|Baseline|Cohort 2: DOR/3TC/TDF|"Participants received DOR/3TC/TDF from Day 0 through Week 96.~Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily"
10801731|NCT03332095|BG002|Baseline|Total|Total of all reporting groups
10801732|NCT03332095|FG000|Participant Flow|Cohort 1: DOR|"Participants received a single dose of DOR at study entry (Day 0).~Doravirine (DOR): 100 mg of DOR administered orally~Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study."
10801733|NCT03332095|FG001|Participant Flow|Cohort 2: DOR/3TC/TDF|"Participants received DOR/3TC/TDF from Day 0 through Week 96.~Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily"
10801734|NCT03332095|OG000|Outcome|Cohort 1: DOR|"Participants received a single dose of DOR at study entry (Day 0).~Doravirine (DOR): 100 mg of DOR administered orally~Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study."
11380655|NCT02879448|BG002|Baseline|Total|Total of all reporting groups
10783060|NCT04296942|BG000|Baseline|1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury|"Arm 1 - Triple Negative Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783061|NCT04296942|BG001|Baseline|2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)|"Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783062|NCT04296942|BG002|Baseline|3/M7824 + BN-Brachyury + T-DM1 + Entinostat|"Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783063|NCT04296942|BG003|Baseline|Total|Total of all reporting groups
10783064|NCT04296942|FG000|Participant Flow|1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury|"Arm 1 - Triple Negative Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783065|NCT04296942|FG001|Participant Flow|2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)|"Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783066|NCT04296942|FG002|Participant Flow|3/M7824 + BN-Brachyury + T-DM1 + Entinostat|"Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10801735|NCT03332095|OG001|Outcome|Cohort 2: DOR/3TC/TDF|"Participants received DOR/3TC/TDF from Day 0 through Week 96.~Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily"
10783067|NCT04296942|OG000|Outcome|1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury|"Arm 1 - Triple Negative Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783068|NCT04296942|OG000|Outcome|2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)|"Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783069|NCT04296942|OG001|Outcome|3/M7824 + BN-Brachyury + T-DM1 + Entinostat|"Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783070|NCT04296942|OG001|Outcome|2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)|"Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783071|NCT04296942|OG002|Outcome|3/M7824 + BN-Brachyury + T-DM1 + Entinostat|"Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783072|NCT04296942|EG000|Reported Event|1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury|"Arm 1 - Triple Negative Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10964604|NCT00878436|BG000|Baseline|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10964605|NCT00878436|BG001|Baseline|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10783073|NCT04296942|EG001|Reported Event|2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)|"Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783074|NCT04296942|EG002|Reported Event|3/M7824 + BN-Brachyury + T-DM1 + Entinostat|"Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.~Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).~Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10^8 infectious units (Inf.U). *Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10^9 Inf.U.~Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.~M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.~Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle."
10783075|NCT04278872|BG000|Baseline|SJX-653|"Participants will receive SJX-653~SJX-653: administered orally once daily"
10783076|NCT04278872|BG001|Baseline|Placebo|"Participants will receive placebo~Placebo: administered orally once daily"
10783077|NCT04278872|BG002|Baseline|Total|Total of all reporting groups
10783078|NCT04278872|FG000|Participant Flow|SJX-653|"Participants will receive SJX-653~SJX-653: administered orally once daily"
11194047|NCT02150057|BG001|Baseline|Experimental Group|This group is assigned to wear the BREG Fusion Osteoarthritis Unloading Brace and report pain and quality of life by completion of a pain diary and related questionnaires.
11194048|NCT02150057|BG002|Baseline|Total|Total of all reporting groups
11194049|NCT02150057|FG000|Participant Flow|Control Group|This group receives no experimental bracing intervention in the study.
11194050|NCT02150057|FG001|Participant Flow|Experimental Group|"Breg Fusion Osteoarthritis knee unloading brace~Fusion Osteoarthritis Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires."
10783079|NCT04278872|FG001|Participant Flow|Placebo|"Participants will receive placebo~Placebo: administered orally once daily"
10783080|NCT04278872|OG000|Outcome|SJX-653|"Participants will receive SJX-653~SJX-653: administered orally once daily"
10783081|NCT04278872|OG001|Outcome|Placebo|"Participants will receive placebo~Placebo: administered orally once daily"
10783082|NCT04278872|EG000|Reported Event|SJX-653|"Participants will receive SJX-653~SJX-653: administered orally once daily"
11194051|NCT02150057|OG000|Outcome|Control Group|This group receives no experimental bracing intervention in the study.
11194052|NCT02150057|OG001|Outcome|Experimental Group|"This group will receive the BREG Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain.~BREG Fusion Unloading Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires."
11194053|NCT02150057|EG000|Reported Event|Control Group|This group receives no experimental bracing intervention in the study.
11194054|NCT02150057|EG001|Reported Event|Experimental Group|"Breg Fusion Osteoarthritis knee unloading brace~Fusion OA Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires."
10783083|NCT04278872|EG001|Reported Event|Placebo|"Participants will receive placebo~Placebo: administered orally once daily"
10783084|NCT04213807|BG000|Baseline|Placebo|Subcutaneous injection of placebo on Day 1, Day 31, and Day 61
10783085|NCT04213807|BG001|Baseline|MAA868 120 mg|Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61
10783086|NCT04213807|BG002|Baseline|MAA868 180 mg|Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61
10783087|NCT04213807|BG003|Baseline|Total|Total of all reporting groups
10783088|NCT04213807|FG000|Participant Flow|Placebo|Subcutaneous injection of placebo on Day 1, Day 31, and Day 61
10783089|NCT04213807|FG001|Participant Flow|MAA868 120 mg|Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61
10783090|NCT04213807|FG002|Participant Flow|MAA868 180 mg|Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61
10783091|NCT04213807|OG000|Outcome|Placebo|Subcutaneous injection of placebo on Day 1, Day 31, and Day 61
10783092|NCT04213807|OG001|Outcome|MAA868 120 mg|Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61
10783093|NCT04213807|OG002|Outcome|MAA868 180 mg|Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61
10783094|NCT04213807|OG000|Outcome|MAA868 120 mg|Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61
10783095|NCT04213807|OG001|Outcome|MAA868 180 mg|Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61
11380656|NCT02879448|FG000|Participant Flow|Amulet|"Amulet left atrial appendage occluder~Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure"
11380657|NCT02879448|FG001|Participant Flow|WATCHMAN (Control)|"WATCHMAN left atrial appendage closure device~WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure"
10783096|NCT04213807|EG000|Reported Event|Placebo|Subcutaneous injection of placebo on Day 1, Day 31, and Day 61
10783097|NCT04213807|EG001|Reported Event|MAA868 120 mg|Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61
10783098|NCT04213807|EG002|Reported Event|MAA868 180 mg|Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61
10783099|NCT04172467|BG000|Baseline|Non-interventional Retrospective Observational Study.|This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
10783100|NCT04172467|FG000|Participant Flow|Not Applicable. Non-interventional Retropspective Observational Study.|This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
10783101|NCT04172467|OG000|Outcome|Non-interventional Retrospective Observational Study.|This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
10783102|NCT04172467|OG000|Outcome|GLAD-Score 2|2 points for full GLAD
10783103|NCT04172467|OG001|Outcome|GLAD-Score 1|1 point for deviations in dose or interval (+/- 10%) or a late start of IgRT (>28 days after a severe infection (≥ grade 3)
10783104|NCT04172467|OG002|Outcome|GLAD-Score 0|0 points for IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection
10783105|NCT04172467|EG000|Reported Event|Non-interventional Retropspective Observational Study.|Data from 1086 patients (CLL 490, MM 596) were collected from 86 centres.
10783106|NCT04132804|BG000|Baseline|Tai Chi Treatment|"All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.~Tai Chi: Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness."
11194055|NCT02150109|BG000|Baseline|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11380658|NCT02879448|OG000|Outcome|Amulet|"Amulet left atrial appendage occluder~Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure"
10783107|NCT04132804|FG000|Participant Flow|Tai Chi Treatment|"All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.~Tai Chi: Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness."
10783108|NCT04132804|OG000|Outcome|Tai Chi Treatment|"All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.~Tai Chi: Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness."
10783109|NCT04132804|EG000|Reported Event|Tai Chi Treatment|"All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.~Tai Chi: Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness."
10801736|NCT03332095|EG000|Reported Event|Cohort 1: DOR|Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
10801737|NCT03332095|EG001|Reported Event|Cohort 2: DOR/3TC/TDF|Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily.
10801738|NCT03201419|BG000|Baseline|FE 201836 500 µg (Randomized Treatment Period)|FE 201836 500 µg oral solution and placebo ODT, administered once daily
10801739|NCT03201419|BG001|Baseline|FE 201836 350 µg (Randomized Treatment Period)|FE 201836 350 µg oral solution and placebo ODT, administered once daily
10801740|NCT03201419|BG002|Baseline|FE 201836 250 µg (Randomized Treatment Period)|FE 201836 250 µg oral solution and placebo ODT, administered once daily
10964606|NCT00878436|BG002|Baseline|Total|Total of all reporting groups
10801741|NCT03201419|BG003|Baseline|FE 201836 150 µg (Randomized Treatment Period)|FE 201836 150 µg oral solution and placebo ODT, administered once daily
10801742|NCT03201419|BG004|Baseline|FE 201836 100 µg (Randomized Treatment Period)|FE 201836 100 µg oral solution and placebo ODT, administered once daily
10801743|NCT03201419|BG005|Baseline|FE 201836 50 µg (Randomized Treatment Period)|FE 201836 50 µg oral solution and placebo ODT, administered once daily
10801744|NCT03201419|BG006|Baseline|Placebo (Randomized Treatment Period)|Placebo oral solution and placebo ODT, administered once daily
10801745|NCT03201419|BG007|Baseline|Desmopressin 25µg (Randomized Treatment Period)|Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
10801746|NCT03201419|BG008|Baseline|Desmopressin 50 µg (Randomized Treatment Period)|Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
10801747|NCT03201419|BG009|Baseline|Total|Total of all reporting groups
10801748|NCT03201419|FG000|Participant Flow|FE 201836 500 µg (Randomized Treatment Period)|FE 201836 500 µg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
10783110|NCT03963011|BG000|Baseline|Arm A: AXR Only|Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care
10783111|NCT03963011|BG001|Baseline|Arm B: AXR + Bowel US|"Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention~Bowel Ultrasound: Ultrasound imaging of the bowel"
10783112|NCT03963011|BG002|Baseline|Total|Total of all reporting groups
10783113|NCT03963011|FG000|Participant Flow|Arm A: AXR Only|Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care
11194056|NCT02150109|FG000|Participant Flow|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11194057|NCT02150109|OG000|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11194058|NCT02150109|OG000|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma."
10783114|NCT03963011|FG001|Participant Flow|Arm B: AXR + Bowel US|"Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention~Bowel Ultrasound: Ultrasound imaging of the bowel"
10783115|NCT03963011|OG000|Outcome|Arm A: AXR Only|Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care
10783116|NCT03963011|OG001|Outcome|Arm B: AXR + Bowel US|"Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention~Bowel Ultrasound: Ultrasound imaging of the bowel"
10783117|NCT03963011|EG000|Reported Event|Arm A: AXR Only|Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care
11194059|NCT02150109|OG000|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11339969|NCT03643432|BG000|Baseline|Usual Care|"The usual care arm will consist of routine physiotherapy treatment, without the intervention.~Usual Care: Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm"
10783118|NCT03963011|EG001|Reported Event|Arm B: AXR + Bowel US|"Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention~Bowel Ultrasound: Ultrasound imaging of the bowel"
10783119|NCT03894501|BG000|Baseline|Mindfulness Oriented Recovery Enhancement|The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
10783120|NCT03894501|BG001|Baseline|Methadone Program Behavioral Treatment as Usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
10783121|NCT03894501|BG002|Baseline|Total|Total of all reporting groups
10783122|NCT03894501|FG000|Participant Flow|Mindfulness Oriented Recovery Enhancement|The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
10783123|NCT03894501|FG001|Participant Flow|Methadone Program Behavioral Treatment as Usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
11194060|NCT02150109|OG000|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
11194061|NCT02150109|OG000|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
11194062|NCT02150109|OG000|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
10783124|NCT03894501|OG000|Outcome|Participants Who Expressed Interest in the Study|Individuals who asked for information on the study or who asked to be screened for eligibility.
10783125|NCT03894501|OG000|Outcome|The Number of Individuals Who Who Refuse Study Participation When Offered.|The number of individuals who who refuse study participation when offered.
10783126|NCT03894501|OG000|Outcome|The Number of Individuals Screened and Ineligible.|The number of individuals screened and ineligible.
10783127|NCT03894501|OG000|Outcome|The Number of Eligible Participants Consented|The number of eligible individuals consented.
10783128|NCT03894501|OG000|Outcome|The Number of Individuals Who Refuse Participation After/During Consent Process.|The number of individuals who refuse participation after/during consent process.
10783129|NCT03894501|OG000|Outcome|The Mean Number of Sessions Completed by Study Participants in the MORE Intervention.|The mean number of sessions completed by study participants in the MORE intervention.
10783130|NCT03894501|OG000|Outcome|The Mean Percentage of Sessions Completed by Study Participants Randomized to MORE.|The mean percentage of sessions completed by study participants randomized to MORE.
10783131|NCT03894501|OG000|Outcome|Number of Participants Who Dropped Out of the Study.|Number of participants who dropped out of the study.
10783132|NCT03894501|OG000|Outcome|Percentage of Participants Who Dropped Out of the Study.|Percentage of participants who dropped out of the study.
10783133|NCT03894501|OG000|Outcome|Baselines Completed|The number of people who completed baseline assessments.
10783134|NCT03894501|OG000|Outcome|Percentage Baselines Completed|The percentage of people who completed baseline assessments.
10783135|NCT03894501|OG000|Outcome|8-weeks Completed|The number of participants who completed 8-week assessments.
10783136|NCT03894501|OG000|Outcome|Percentage 8-weeks Completed|The percentage of participants who completed 8-week assessments.
10783137|NCT03894501|OG000|Outcome|16-Weeks Completed|The number of participants who completed 16-week assessments.
10783138|NCT03894501|OG000|Outcome|Percentage of 16-weeks Completed|The percentage of participants who completed 16-week assessments.
10783139|NCT03894501|OG000|Outcome|Mindfulness Oriented Recovery Enhancement|The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
10783140|NCT03894501|OG001|Outcome|Methadone Program Behavioral Treatment as Usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
10783141|NCT03894501|EG000|Reported Event|Mindfulness Oriented Recovery Enhancement|The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
10783142|NCT03894501|EG001|Reported Event|Methadone Program Behavioral Treatment as Usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
10801749|NCT03201419|FG001|Participant Flow|FE 201836 350 µg (Randomized Treatment Period)|FE 201836 350 µg oral solution and placebo ODT, administered once daily
10783143|NCT03837184|BG000|Baseline|AVXS-101|Participants received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783144|NCT03837184|FG000|Participant Flow|AVXS-101|Participants received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783145|NCT03837184|OG000|Outcome|AVXS-101|Participants received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783146|NCT03837184|EG000|Reported Event|AVXS-101|Participants received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10801750|NCT03201419|FG002|Participant Flow|FE 201836 250 µg (Randomized Treatment Period)|FE 201836 250 µg oral solution and placebo ODT, administered once daily
10801751|NCT03201419|FG003|Participant Flow|FE 201836 150 µg (Randomized Treatment Period)|FE 201836 150 µg oral solution and placebo ODT, administered once daily
10801752|NCT03201419|FG004|Participant Flow|FE 201836 100 µg (Randomized Treatment Period)|FE 201836 100 µg oral solution and placebo ODT, administered once daily
10801753|NCT03201419|FG005|Participant Flow|FE 201836 50 µg (Randomized Treatment Period)|FE 201836 50 µg oral solution and placebo ODT, administered once daily
10801754|NCT03201419|FG006|Participant Flow|Placebo (Randomized Treatment Period)|Placebo oral solution and placebo ODT, administered once daily
10801755|NCT03201419|FG007|Participant Flow|Desmopressin 25 µg (Randomized Treatment Period)|Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
11339981|NCT03643575|FG002|Participant Flow|Treatment Sequence 3|"Period 1: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment A~Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment B~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
10801756|NCT03201419|FG008|Participant Flow|Desmopressin 50 µg (Randomized Treatment Period)|Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
10801757|NCT03201419|OG000|Outcome|FE 201836 500 ug (Randomized Treatment Period)|FE 201836 500 µg oral solution and placebo ODT, administered once daily
10801758|NCT03201419|OG001|Outcome|FE 201836 350 ug (Randomized Treatment Period)|FE 201836 350 µg oral solution and placebo ODT, administered once daily
10801759|NCT03201419|OG002|Outcome|FE 201836 250 ug (Randomized Treatment Period)|FE 201836 250 µg oral solution and placebo ODT, administered once daily
10801760|NCT03201419|OG003|Outcome|FE 201836 150 ug (Randomized Treatment Period)|FE 201836 150 µg oral solution and placebo ODT, administered once daily
10801761|NCT03201419|OG004|Outcome|FE 201836 100 ug (Randomized Treatment Period)|FE 201836 100 µg oral solution and placebo ODT, administered once daily
10801762|NCT03201419|OG005|Outcome|FE 201836 50 ug (Randomized Treatment Period)|FE 201836 50 µg oral solution and placebo ODT, administered once daily
10801763|NCT03201419|OG006|Outcome|Placebo (Randomized Treatment Period)|Placebo oral solution and placebo ODT, administered once daily
10801764|NCT03201419|OG005|Outcome|FE 201836 50 ug (Randomized Treatment Period)|FE 201836 50 µg oral solution and placebo ODT, administered once dail
10801765|NCT03201419|OG001|Outcome|FE 201836 350 ug (Randomized Treatment Period)|FE 201836 500 µg oral solution and placebo ODT, administered once daily
10801766|NCT03201419|OG000|Outcome|FE 201836 500 ug (Randomized Treatment Period)|FE 201836 500 μg oral solution and placebo ODT, administered once daily
10801767|NCT03201419|OG001|Outcome|FE 201836 350 ug (Randomized Treatment Period)|FE 201836 350 μg oral solution and placebo ODT, administered once daily
10801768|NCT03201419|OG002|Outcome|FE 201836 250 ug (Randomized Treatment Period)|FE 201836 250 μg oral solution and placebo ODT, administered once daily
10801769|NCT03201419|OG003|Outcome|FE 201836 150 ug (Randomized Treatment Period)|FE 201836 150 μg oral solution and placebo ODT, administered once daily
10801770|NCT03201419|OG004|Outcome|FE 201836 100 ug (Randomized Treatment Period)|FE 201836 100 μg oral solution and placebo ODT, administered once daily
10801771|NCT03201419|OG005|Outcome|FE 201836 50 ug (Randomized Treatment Period)|FE 201836 50 μg oral solution and placebo ODT, administered once daily
10801772|NCT03201419|OG000|Outcome|FE 201836 500 ug (Randomized Treatment Period)|FE 201836 500 µg oral solution for daily intake
10801773|NCT03201419|OG001|Outcome|FE 201836 350 ug (Randomized Treatment Period)|FE 201836 350 µg oral solution for daily intake
10801774|NCT03201419|OG002|Outcome|FE 201836 250 ug (Randomized Treatment Period)|FE 201836 250 µg oral solution for daily intake
10801775|NCT03201419|OG003|Outcome|FE 201836 150 ug (Randomized Treatment Period)|FE 201836 150 µg oral solution for daily intake
10801776|NCT03201419|OG004|Outcome|FE 201836 100 ug (Randomized Treatment Period)|FE 201836 100 µg oral solution for daily intake
10801777|NCT03201419|OG005|Outcome|FE 201836 50 ug (Randomized Treatment Period)|FE 201836 50 µg oral solution for daily intake
10801778|NCT03201419|OG006|Outcome|Placebo (Randomized Treatment Period)|Placebo ODT, mimics active comparator drug
10783147|NCT03735420|BG000|Baseline|Xanthohumol|"Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.~Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks."
10783148|NCT03735420|BG001|Baseline|Placebo Oral Capsule|"Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.~Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal."
10783149|NCT03735420|BG002|Baseline|Total|Total of all reporting groups
10783150|NCT03735420|FG000|Participant Flow|Xanthohumol|"Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.~Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks."
10783151|NCT03735420|FG001|Participant Flow|Placebo Oral Capsule|"Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.~Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal."
10783152|NCT03735420|OG000|Outcome|Placebo Oral Capsule|"Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.~Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal."
10783153|NCT03735420|OG001|Outcome|Xanthohumol|"Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.~Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks."
10783154|NCT03735420|OG000|Outcome|Xanthohumol|"Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.~Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks."
10783155|NCT03735420|OG001|Outcome|Placebo Oral Capsule|"Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.~Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal."
11338894|NCT03619811|EG000|Reported Event|Symptomatic|"This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)~Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms."
10964607|NCT00878436|FG000|Participant Flow|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10783156|NCT03735420|EG000|Reported Event|Xanthohumol|"Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.~Xanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks."
10783157|NCT03735420|EG001|Reported Event|Placebo Oral Capsule|"Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.~Placebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal."
10783158|NCT03721328|BG000|Baseline|Experimental|"Joint irrigation with vancomycin and tobramycin~vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation"
10783159|NCT03721328|FG000|Participant Flow|Local Irrigation With Vancomycin + Tobramycin|"Joint irrigation with vancomycin and tobramycin~vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation"
10783160|NCT03721328|OG000|Outcome|Experimental|"Joint irrigation with vancomycin and tobramycin~vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation"
10783161|NCT03721328|EG000|Reported Event|Local Irrigation With Vancomycin + Tobramycin|"Joint irrigation with vancomycin and tobramycin~vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation"
10964608|NCT00878436|FG001|Participant Flow|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10783162|NCT03721107|BG000|Baseline|Cohort C: Blautix|Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783163|NCT03721107|BG001|Baseline|Cohort C: Placebo|Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783164|NCT03721107|BG002|Baseline|Cohort D: Blautix|Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783165|NCT03721107|BG003|Baseline|Cohort D: Placebo|Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783166|NCT03721107|BG004|Baseline|Total|Total of all reporting groups
10783167|NCT03721107|FG000|Participant Flow|Cohort C: Blautix|Participants diagnosed with Irritable Bowel Syndrome Subtype-C (IBS-C) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 most probable number (MPN).
10783168|NCT03721107|FG001|Participant Flow|Cohort C: Placebo|Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10801779|NCT03201419|EG000|Reported Event|FE 201836 500 µg (Enrichment Period)|FE 201836 500 µg oral solution and placebo ODT, administered once daily
10783169|NCT03721107|FG002|Participant Flow|Cohort D: Blautix|Participants diagnosed with Irritable Bowel Syndrome Subtype-D (IBS-D) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783170|NCT03721107|FG003|Participant Flow|Cohort D: Placebo|Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783171|NCT03721107|OG000|Outcome|Cohort C: Blautix|Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783172|NCT03721107|OG001|Outcome|Cohort C: Placebo|Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783173|NCT03721107|OG002|Outcome|Cohort D: Blautix|Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783174|NCT03721107|OG003|Outcome|Cohort D: Placebo|Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783175|NCT03721107|EG000|Reported Event|Cohort C: Blautix|Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783176|NCT03721107|EG001|Reported Event|Cohort C: Placebo|Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783177|NCT03721107|EG002|Reported Event|Cohort D: Blautix|Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10^10 to 10^11 MPN.
10783178|NCT03721107|EG003|Reported Event|Cohort D: Placebo|Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
10783179|NCT03691727|BG000|Baseline|Tirofiban Hydrochloride (AGGRASTAT®)|"tirofiban hydrochloride (AGGRASTAT®) administered continuously over the course of 7 days.~MRI Neurological Exam Vital Signs Questionnaires~tirofiban hydrochloride (AGGRASTAT®): Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits."
10783180|NCT03691727|BG001|Baseline|Standard of Care Control Arm|"Standard of Care Treatment MRI Neurological Exam Vital Signs Questionnaires~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Standard of Care Treatment: Participants will receive standard of care treatment and will not receive study drug."
10783181|NCT03691727|BG002|Baseline|Total|Total of all reporting groups
10783182|NCT03691727|FG000|Participant Flow|Tirofiban Hydrochloride (AGGRASTAT®)|"tirofiban hydrochloride (AGGRASTAT®) administered continuously over the course of 7 days.~MRI Neurological Exam Vital Signs Questionnaires~tirofiban hydrochloride (AGGRASTAT®): Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits."
10783183|NCT03691727|FG001|Participant Flow|Standard of Care Control Arm|"Standard of Care Treatment MRI Neurological Exam Vital Signs Questionnaires~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Standard of Care Treatment: Participants will receive standard of care treatment and will not receive study drug."
10801780|NCT03201419|EG001|Reported Event|FE 201836 500 µg (Randomized Treatment Period)|FE 201836 500 µg oral solution and placebo ODT, administered once daily
10801781|NCT03201419|EG002|Reported Event|FE 201836 350 µg (Randomized Treatment Period)|FE 201836 350 µg oral solution and placebo ODT, administered once daily
10801782|NCT03201419|EG003|Reported Event|FE 201836 250 µg (Randomized Treatment Period)|FE 201836 250 µg oral solution and placebo ODT, administered once daily
10801783|NCT03201419|EG004|Reported Event|FE 201836 150 µg (Randomized Treatment Period)|FE 201836 150 µg oral solution and placebo ODT, administered once daily
10801784|NCT03201419|EG005|Reported Event|FE 201836 100 µg (Randomized Treatment Period)|FE 201836 100 µg oral solution and placebo ODT, administered once daily
10783184|NCT03691727|OG000|Outcome|Tirofiban Hydrochloride (AGGRASTAT®)|"tirofiban hydrochloride (AGGRASTAT®) administered continuously over the course of 7 days.~MRI Neurological Exam Vital Signs Questionnaires~tirofiban hydrochloride (AGGRASTAT®): Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits."
10783185|NCT03691727|OG001|Outcome|Standard of Care Control Arm|"Standard of Care Treatment MRI Neurological Exam Vital Signs Questionnaires~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Standard of Care Treatment: Participants will receive standard of care treatment and will not receive study drug."
10783186|NCT03691727|EG000|Reported Event|Tirofiban Hydrochloride (AGGRASTAT®)|"tirofiban hydrochloride (AGGRASTAT®) administered continuously over the course of 7 days.~MRI Neurological Exam Vital Signs Questionnaires~tirofiban hydrochloride (AGGRASTAT®): Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits."
10783187|NCT03691727|EG001|Reported Event|Standard of Care Control Arm|"Standard of Care Treatment MRI Neurological Exam Vital Signs Questionnaires~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Questionnaires: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.~Vital Signs: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~Standard of Care Treatment: Participants will receive standard of care treatment and will not receive study drug."
10783188|NCT03689920|BG000|Baseline|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783189|NCT03689920|BG001|Baseline|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783190|NCT03689920|BG002|Baseline|Total|Total of all reporting groups
10783191|NCT03689920|FG000|Participant Flow|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783192|NCT03689920|FG001|Participant Flow|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783193|NCT03689920|OG000|Outcome|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783194|NCT03689920|OG001|Outcome|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10801785|NCT03201419|EG006|Reported Event|FE 201836 50 µg (Randomized Treatment Period)|FE 201836 50 µg oral solution and placebo ODT, administered once daily
11380659|NCT02879448|OG001|Outcome|WATCHMAN (Control)|"WATCHMAN left atrial appendage closure device~WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure"
11380660|NCT02879448|EG000|Reported Event|Amulet|"Amulet left atrial appendage occluder~Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure"
11380661|NCT02879448|EG001|Reported Event|WATCHMAN (Control)|"WATCHMAN left atrial appendage closure device~WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure"
11380662|NCT02547662|BG000|Baseline|Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)|Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
11380663|NCT02547662|FG000|Participant Flow|Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)|Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
11380664|NCT02547662|OG000|Outcome|Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)|Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
11380665|NCT02547662|EG000|Reported Event|Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)|Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
11380666|NCT02348216|BG000|Baseline|Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy|Participants with DLBCL, primary PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380667|NCT02348216|BG001|Baseline|Phase 2 (Pivotal Study): Cohort 1|Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380668|NCT02348216|BG002|Baseline|Phase 2 (Pivotal Study): Cohort 2|Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
10801786|NCT03201419|EG007|Reported Event|Placebo (Randomized Treatment Period)|Placebo oral solution and placebo ODT, administered once daily
11380669|NCT02348216|BG003|Baseline|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV BID) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
11380670|NCT02348216|BG004|Baseline|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
10783195|NCT03689920|EG000|Reported Event|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783196|NCT03689920|EG001|Reported Event|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10783197|NCT03672227|BG000|Baseline|Mealtime Matters Training|"This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.~Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children."
10783198|NCT03672227|BG001|Baseline|Family Style Dining in Head Start|This group of teachers will not get the nutrition training until the study has concluded.
10783199|NCT03672227|BG002|Baseline|Total|Total of all reporting groups
10783200|NCT03672227|FG000|Participant Flow|Mealtime Matters Training|"This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.~Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children."
10783201|NCT03672227|FG001|Participant Flow|Family Style Dining in Head Start|This group of teachers will not get the nutrition training until the study has concluded.
10783202|NCT03672227|OG000|Outcome|Mealtime Matters Training|"This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.~Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children."
10783203|NCT03672227|OG001|Outcome|Family Style Dining in Head Start|This group of teachers will not get the nutrition training until the study has concluded.
10783204|NCT03672227|OG001|Outcome|Family Style Dining in Head Start|This group of teachers will not get the 3 hour nutrition training until the study has concluded.
11194063|NCT02150109|OG000|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
10783205|NCT03672227|EG000|Reported Event|Mealtime Matters Training|"This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.~Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children."
10783206|NCT03672227|EG001|Reported Event|Family Style Dining in Head Start|This group of teachers will not get the nutrition training until the study has concluded.
10783207|NCT03644849|BG000|Baseline|Fractional Carbon Dioxide Laser Intervention Group|"The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).~CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery."
10783208|NCT03644849|BG001|Baseline|Sham Laser Intervention Group|Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
10783209|NCT03644849|BG002|Baseline|Total|Total of all reporting groups
10783210|NCT03644849|FG000|Participant Flow|Fractional Carbon Dioxide Laser Intervention Group|"The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).~CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery."
10783211|NCT03644849|FG001|Participant Flow|Sham Laser Intervention Group|Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
10783212|NCT03644849|OG000|Outcome|Fractional Carbon Dioxide Laser Intervention Group|"The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).~CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery."
10783213|NCT03644849|OG001|Outcome|Sham Laser Intervention Group|Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
10783214|NCT03644849|EG000|Reported Event|Fractional Carbon Dioxide Laser Intervention Group|"The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).~CO2RE® (Syneron Candela Corp, Wayland, MA): The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery."
10783215|NCT03644849|EG001|Reported Event|Sham Laser Intervention Group|Sham laser treatment: A physician who is not blinded will perform a sham laser treatment on blinded subjects.
10801787|NCT03201419|EG008|Reported Event|Desmopressin 25 µg (Randomized Treatment Period)|Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
10783216|NCT03604159|BG000|Baseline|Buprenorphine Extended-Release|"XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.~Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle."
10783217|NCT03604159|BG001|Baseline|Sublingual Buprenorphine|"SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.~Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response."
10783218|NCT03604159|BG002|Baseline|Total|Total of all reporting groups
10783219|NCT03604159|FG000|Participant Flow|Buprenorphine Extended-Release|"XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.~Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle."
10783220|NCT03604159|FG001|Participant Flow|Sublingual Buprenorphine|"SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.~Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response."
10783221|NCT03604159|OG000|Outcome|Buprenorphine Extended-Release|"XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.~Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle."
10783222|NCT03604159|OG001|Outcome|Sublingual Buprenorphine|"SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.~Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response."
10783223|NCT03604159|EG000|Reported Event|Buprenorphine Extended-Release|"XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.~Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle."
10801788|NCT03201419|EG009|Reported Event|Desmopressin 50 µg (Randomized Treatment Period)|Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
10801789|NCT03197766|BG000|Baseline|BMN 111 - 15 μg/kg|BMN 111: Subcutaneous injection of 15 μg/kg of BMN 111 daily
10801790|NCT03197766|BG001|Baseline|Placebo|Placebo: Subcutaneous injection of placebo daily
10801791|NCT03197766|BG002|Baseline|Total|Total of all reporting groups
10801792|NCT03197766|FG000|Participant Flow|BMN 111 - 15 μg/kg|BMN 111: Subcutaneous injection of 15 μg/kg of BMN 111 daily
10801793|NCT03197766|FG001|Participant Flow|Placebo|Placebo: Subcutaneous injection of placebo daily
10801794|NCT03197766|OG000|Outcome|BMN 111 - 15 μg/kg|BMN 111: Subcutaneous injection of 15 μg/kg of BMN 111 daily
10801795|NCT03197766|OG001|Outcome|Placebo|Placebo: Subcutaneous injection of placebo daily
10783224|NCT03604159|EG001|Reported Event|Sublingual Buprenorphine|"SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.~Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response."
10783225|NCT03602885|BG000|Baseline|Chemotherapy Education Intervention Arm|"Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician.~Chemotherapy education intervention (CEI): Video, booklet, and website educational materials"
10783226|NCT03602885|BG001|Baseline|Usual Chemotherapy Education Arm|"Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice.~Usual chemotherapy education (CE): Standard chemo education will given per hospital guideline"
10783227|NCT03602885|BG002|Baseline|Total|Total of all reporting groups
10783228|NCT03602885|FG000|Participant Flow|Chemotherapy Education Intervention Arm|"Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician.~Chemotherapy education intervention (CEI): Video, booklet, and website educational materials"
10783229|NCT03602885|FG001|Participant Flow|Usual Chemotherapy Education Arm|"Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice.~Usual chemotherapy education (CE): Standard chemo education will given per hospital guideline"
10783230|NCT03602885|OG000|Outcome|Chemotherapy Education Intervention Arm|"Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician.~Chemotherapy education intervention (CEI): Video, booklet, and website educational materials"
10783231|NCT03602885|OG001|Outcome|Usual Chemotherapy Education Arm|"Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice.~Usual chemotherapy education (CE): Standard chemo education will given per hospital guideline"
10783232|NCT03602885|EG000|Reported Event|Chemotherapy Education Intervention Arm|"Patients randomized to the chemotherapy education intervention (CEI) arm will be given regimen specific written and video chemotherapy educational materials developed by the study team. The treating oncologist will identify which chemotherapy regimen(s) are being considered, in order to select the appropriate chemotherapy educational tool(s) to give the patient. The patient may be given more than one CEI tool if they are considering more than one regimen. Patients randomized to the intervention arm may receive the intervention in addition to OR in place of the standard institutionally approved chemotherapy information sheets (both are acceptable); this is at the discretion of the treating site or the treating physician.~Chemotherapy education intervention (CEI): Video, booklet, and website educational materials"
10783233|NCT03602885|EG001|Reported Event|Usual Chemotherapy Education Arm|"Patients randomized to the usual chemotherapy education (CE) arm will undergo the standard institutional practice of chemotherapy education. The oncologist may also choose to give the patient the institutionally approved chemotherapy information sheets according to site-specific policies and clinical practice.~Usual chemotherapy education (CE): Standard chemo education will given per hospital guideline"
11338895|NCT03619837|BG000|Baseline|Transplant Recipients|"Single Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for12 weeks. Sofosbuvir/Velpatasvir:Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.~Sofosbuvir/Velpatasvir/Voxilaprevir:Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. [no patients failed initial treatment] Dosage: 400mg/100mg/100mg daily for12 weeks."
10783234|NCT03539601|BG000|Baseline|Vehicle|Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
11194064|NCT02150109|EG000|Reported Event|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
10783235|NCT03539601|BG001|Baseline|Crisaborole Ointment 2% BID|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783236|NCT03539601|BG002|Baseline|Hydrocortisone Butyrate Cream 0.1% BID|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783237|NCT03539601|BG003|Baseline|Pimecrolimus Cream 1% BID|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783238|NCT03539601|BG004|Baseline|Total|Total of all reporting groups
10783239|NCT03539601|FG000|Participant Flow|Vehicle|Vehicle matched to crisaborole 2% ointment was applied topically bis in diem (BID - twice a day) to all treatable atopic dermatitis (AD) involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783240|NCT03539601|FG001|Participant Flow|Crisaborole Ointment 2% BID|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783241|NCT03539601|FG002|Participant Flow|Hydrocortisone Butyrate Cream 0.1% BID|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783242|NCT03539601|FG003|Participant Flow|Pimecrolimus Cream 1% BID|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783243|NCT03539601|OG000|Outcome|Vehicle: Participants 2-17 Years|Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783244|NCT03539601|OG001|Outcome|Crisaborole Ointment 2% BID: Participants 2-17 Years|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783245|NCT03539601|OG002|Outcome|Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783246|NCT03539601|OG003|Outcome|Pimecrolimus Cream 1% BID: Participants 2-17 Years|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
11194065|NCT02150213|BG000|Baseline|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
10783247|NCT03539601|OG004|Outcome|Vehicle: Participants >=18 Years|Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783248|NCT03539601|OG005|Outcome|Crisaborole Ointment 2% BID: Participants >=18 Years|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783249|NCT03539601|OG006|Outcome|Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783250|NCT03539601|OG007|Outcome|Pimecrolimus Cream 1% BID: Participants >=18 Years|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10801796|NCT03197766|EG000|Reported Event|BMN 111 - 15 μg/kg|BMN 111: Subcutaneous injection of 15 μg/kg of BMN 111 daily
10801797|NCT03197766|EG001|Reported Event|Placebo|Placebo: Subcutaneous injection of placebo daily
10783251|NCT03539601|OG000|Outcome|Vehicle|Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783252|NCT03539601|OG001|Outcome|Crisaborole Ointment 2% BID|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783253|NCT03539601|OG002|Outcome|Hydrocortisone Butyrate Cream 0.1% BID|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783254|NCT03539601|OG003|Outcome|Pimecrolimus Cream 1% BID|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783255|NCT03539601|EG000|Reported Event|Vehicle|Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783256|NCT03539601|EG001|Reported Event|Crisaborole Ointment 2% BID|Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783257|NCT03539601|EG002|Reported Event|Hydrocortisone Butyrate Cream 0.1% BID|Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783258|NCT03539601|EG003|Reported Event|Pimecrolimus Cream 1% BID|Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
10783259|NCT03539458|BG000|Baseline|Device Arm|All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
10783260|NCT03539458|FG000|Participant Flow|Device Arm|All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
10783261|NCT03539458|OG000|Outcome|Device Arm|All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
10783262|NCT03539458|EG000|Reported Event|Device Arm|All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
10783263|NCT03532451|BG000|Baseline|Cohort 1: Nivolumab|"Nivolumab 480 mg IV on week 0 and week 4~Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783264|NCT03532451|BG001|Baseline|Cohort 2: Nivolumab/Lirilumab|"Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4~Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783265|NCT03532451|BG002|Baseline|Total|Total of all reporting groups
10783266|NCT03532451|FG000|Participant Flow|Cohort 1: Nivolumab|"Nivolumab 480 mg IV on week 0 and week 4~Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783267|NCT03532451|FG001|Participant Flow|Cohort 2: Nivolumab/Lirilumab|"Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4~Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783268|NCT03532451|OG000|Outcome|Cohort 1: Nivolumab|"Nivolumab 480 mg IV on week 0 and week 4~Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783269|NCT03532451|OG001|Outcome|Cohort 2: Nivolumab/Lirilumab|"Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4~Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10783270|NCT03532451|EG000|Reported Event|Cohort 1: Nivolumab|"Nivolumab 480 mg IV on week 0 and week 4~Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10801808|NCT04516759|BG000|Baseline|AZD1656 (Plus Usual Hospital Care)|"50mg film-coated tablets at a dose of 100mg BID~AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)"
10801809|NCT04516759|BG001|Baseline|Matched Placebo (Plus Usual Hospital Care)|"Matched placebo tablets~Placebo: Matched placebo tablets"
10783271|NCT03532451|EG001|Reported Event|Cohort 2: Nivolumab/Lirilumab|"Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4~Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion."
10801798|NCT05143801|BG000|Baseline|Participation in Four Different Conditions|"Ten recreationally trained participants (5 males; 5 females) were recruited for this study. Participants were free from known cardiovascular, renal, metabolic, or chronic respiratory disease (i.e., asthma) as determined from a health history questionnaire. Participants were excluded if in the last 6 months they smoked and performed less than 150 minutes of moderate-intensity exercise per week, had a maximal oxygen consumption capacity below the 50th percentile for age and sex according to the American College of Sport Medicine guidelines for aerobic fitness, or reported no experience performing high intensity interval exercise. A pregnancy test was completed for female participants to include only non-pregnant participants.~A randomized non-counterbalanced crossover repeated measures design was used to compare cardiovascular, thermoregulatory, metabolic, and perceived responses before and during high intensity across four experimental trials performed during two visits. The high intensity interval exercise sessions were performed in a temperate environment (23°C, 25% relative humidity) with and without a surgical mask, and in a hot environment (36°C, 14% relative humidity) with and without a surgical mask."
10801799|NCT05143801|FG000|Participant Flow|All Participants|Ten recreationally trained participants (5 males; 5 females) were recruited for this study. A randomized non-counterbalanced crossover repeated measures design was used to compare cardiovascular, thermoregulatory, metabolic, and perceived responses before and during high intensity interval exercise across four experimental trials performed during two visits with each visit lasting approximately 4 hours. For each high intensity interval exercise visit, which was separated by a minimum of 72 hours, the participants completed two high intensity interval exercise sessions separated by 3 hours of rest. The high intensity interval exercise sessions were performed in a temperate environment with and without a surgical mask, and in a hot environment with and without a surgical mask. During the 3-hour rest period participants were provided a 350-calorie meal (7 grams of Fat; 64 grams Carbohydrate; 9 grams of Protein) and water ad libitum.
10801800|NCT05143801|OG000|Outcome|No Mask Temperate|"Participant exercised in room temperature environment not wearing a surgical face mask~High-intensity interval exercise without using a surgical face mask in a temperate environment: Participants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask"
10801801|NCT05143801|OG001|Outcome|Mask Temperate|"Participant exercised in room temperature environment while wearing a surgical face mask~High-intensity interval exercise with surgical face mask in a temperate environment: Participants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask"
10801802|NCT05143801|OG002|Outcome|No Mask Hot|"Participant exercised in a hot environmental temperature not wearing a surgical face mask~High-intensity interval exercise without using a surgical face mask in a hot environment: Participants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask"
10801803|NCT05143801|OG003|Outcome|Mask Hot|"Participant exercised in a hot environmental temperature while wearing a surgical face mask~High-intensity interval exercise with surgical face mask in a hot environment: Participants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask"
10801804|NCT05143801|EG000|Reported Event|No Mask Temperate|High-intensity interval exercise without using a surgical face mask in a temperate environment Participants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask.
10801805|NCT05143801|EG001|Reported Event|Mask Temperate|Device: High-intensity interval exercise with surgical face mask in a temperate environment Participants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask
10801806|NCT05143801|EG002|Reported Event|No Mask Hot|High-intensity interval exercise without using a surgical face mask in a hot environment Participants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask.
10801807|NCT05143801|EG003|Reported Event|Mask Hot|Device: High-intensity interval exercise with surgical face mask in a hot environment Participants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask
10801810|NCT04516759|BG002|Baseline|Total|Total of all reporting groups
10801811|NCT04516759|FG000|Participant Flow|AZD1656 (Plus Usual Hospital Care)|"50mg film-coated tablets at a dose of 100mg BID~AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)"
10801812|NCT04516759|FG001|Participant Flow|Matched Placebo (Plus Usual Hospital Care)|"Matched placebo tablets~Placebo: Matched placebo tablets"
10801813|NCT04516759|OG000|Outcome|AZD1656 (Plus Usual Hospital Care)|"50mg film-coated tablets at a dose of 100mg BID~AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)"
10801814|NCT04516759|OG001|Outcome|Matched Placebo (Plus Usual Hospital Care)|"Matched placebo tablets~Placebo: Matched placebo tablets"
10801815|NCT04516759|EG000|Reported Event|AZD1656 (Plus Usual Hospital Care)|"50mg film-coated tablets at a dose of 100mg BID~AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)"
10801816|NCT04516759|EG001|Reported Event|Matched Placebo (Plus Usual Hospital Care)|"Matched placebo tablets~Placebo: Matched placebo tablets"
10803744|NCT02134028|BG002|Baseline|Participants From EFC13579: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10850629|NCT00303667|FG001|Participant Flow|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
10783272|NCT03505099|BG000|Baseline|Cohort 1: Bi-allelic Deletions of SMN1 and 2 Copies of SMN2|Participants with bi-allelic deletions of survival of motor neuron 1 (SMN1) and 2 copies of SMN2 received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783273|NCT03505099|BG001|Baseline|Cohort 2: Bi-allelic Deletions of SMN1 and 3 Copies of SMN2|Participants with bi-allelic deletions of SMN1 and 3 copies of SMN2 received a single dose of AVXS-101 administered as an IV infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued
10783274|NCT03505099|BG002|Baseline|Total|Total of all reporting groups
10783275|NCT03505099|FG000|Participant Flow|Cohort 1: Bi-allelic Deletions of SMN1 and 2 Copies of SMN2|Participants with bi-allelic deletions of survival of motor neuron 1 (SMN1) and 2 copies of SMN2 received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783276|NCT03505099|FG001|Participant Flow|Cohort 2: Bi-allelic Deletions of SMN1 and 3 Copies of SMN2|Participants with bi-allelic deletions of SMN1 and 3 copies of SMN2 received a single dose of AVXS-101 administered as an IV infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783277|NCT03505099|OG000|Outcome|Cohort 1: Bi-allelic Deletions of SMN1 and 2 Copies of SMN2|Participants with bi-allelic deletions of survival of motor neuron 1 (SMN1) and 2 copies of SMN2 received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783278|NCT03505099|OG000|Outcome|Cohort 2: Bi-allelic Deletions of SMN1 and 3 Copies of SMN2|Participants with bi-allelic deletions of SMN1 and 3 copies of SMN2 received a single dose of AVXS-101 administered as an IV infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783279|NCT03505099|EG000|Reported Event|Cohort 1: Bi-allelic Deletions of SMN1 and 2 Copies of SMN2|Participants with bi-allelic deletions of survival of motor neuron 1 (SMN1) and 2 copies of SMN2 received a single dose of AVXS-101 administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783280|NCT03505099|EG001|Reported Event|Cohort 2: Bi-allelic Deletions of SMN1 and 3 Copies of SMN2|Participants with bi-allelic deletions of SMN1 and 3 copies of SMN2 received a single dose of AVXS-101 administered as an IV infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg on Day 1 of the overall study. Participants also received daily doses of prophylactic oral prednisolone starting at a dose of 1-2 mg/kg/day from 1 day prior to AVXS-101 infusion until at least 30 days post-infusion at which point the prednisolone dose could be tapered downwards. At week 9, prednisolone could be discontinued.
10783281|NCT03494647|BG000|Baseline|Cheetah Heel Cup|"Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.~Cheetah Heel Cup: The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve."
10783282|NCT03494647|BG001|Baseline|The X Brace|"Subjects randomly assigned to this group will receive the X Brace at their initial visit.~The X Brace: The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot."
10783283|NCT03494647|BG002|Baseline|Total|Total of all reporting groups
10783284|NCT03494647|FG000|Participant Flow|Cheetah Heel Cup|"Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.~Cheetah Heel Cup: The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve."
10783285|NCT03494647|FG001|Participant Flow|The X Brace|"Subjects randomly assigned to this group will receive the X Brace at their initial visit.~The X Brace: The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot."
10783286|NCT03494647|OG000|Outcome|Cheetah Heel Cup|"Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.~Cheetah Heel Cup: The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve."
10783287|NCT03494647|OG001|Outcome|The X Brace|"Subjects randomly assigned to this group will receive the X Brace at their initial visit.~The X Brace: The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot."
10783288|NCT03494647|EG000|Reported Event|Cheetah Heel Cup|"Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.~Cheetah Heel Cup: The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve."
10783289|NCT03494647|EG001|Reported Event|The X Brace|"Subjects randomly assigned to this group will receive the X Brace at their initial visit.~The X Brace: The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot."
10964609|NCT00878436|OG000|Outcome|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10964610|NCT00878436|OG001|Outcome|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10964611|NCT00878436|EG000|Reported Event|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10964612|NCT00878436|EG001|Reported Event|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
10964613|NCT00878501|BG000|Baseline|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
10964614|NCT00878501|BG001|Baseline|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
10964615|NCT00878501|BG002|Baseline|Placebo Control|Placebo bid for 4 weeks
10964616|NCT00878501|BG003|Baseline|Total|Total of all reporting groups
10964617|NCT00878501|FG000|Participant Flow|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
10783299|NCT03439657|BG000|Baseline|Co-Ad Group|Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783300|NCT03439657|BG001|Baseline|Control Group|Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783301|NCT03439657|BG002|Baseline|Total|Total of all reporting groups
10783302|NCT03439657|FG000|Participant Flow|Co-Ad Group|Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783303|NCT03439657|FG001|Participant Flow|Control Group|Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783304|NCT03439657|OG000|Outcome|Co-Ad Group|Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783305|NCT03439657|OG001|Outcome|Control Group|Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783306|NCT03439657|OG000|Outcome|Control Group|Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10964618|NCT00878501|FG001|Participant Flow|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
10964619|NCT00878501|FG002|Participant Flow|Placebo Control|Placebo bid for 4 weeks
10964620|NCT00878501|OG000|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
10964621|NCT00878501|OG001|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
10964622|NCT00878501|OG002|Outcome|Placebo Control|Placebo bid for 4 weeks
10964623|NCT00878501|EG000|Reported Event|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
10964624|NCT00878501|EG001|Reported Event|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
10964625|NCT00878501|EG002|Reported Event|Placebo Control|Placebo bid for 4 weeks
10964626|NCT00878553|BG000|Baseline|Sequence 1|10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
10964627|NCT00878553|BG001|Baseline|Sequence 2|Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
10964628|NCT00878553|BG002|Baseline|Sequence 3|20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
10964629|NCT00878553|BG003|Baseline|Sequence 4|15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
10964630|NCT00878553|BG004|Baseline|Total|Total of all reporting groups
10966600|NCT00887679|OG000|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.
10966601|NCT00887679|OG000|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
10966602|NCT00887679|EG000|Reported Event|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
10783307|NCT03439657|OG001|Outcome|Co-Ad Group|Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783308|NCT03439657|EG000|Reported Event|Co-Ad Group|Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783309|NCT03439657|EG001|Reported Event|Control Group|Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
10783310|NCT03377790|BG000|Baseline|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions"
10783311|NCT03377790|BG001|Baseline|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions"
10783312|NCT03377790|BG002|Baseline|Total|Total of all reporting groups
10783313|NCT03377790|FG000|Participant Flow|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions"
10783314|NCT03377790|FG001|Participant Flow|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions"
10783315|NCT03377790|OG000|Outcome|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions"
10783316|NCT03377790|OG001|Outcome|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions"
10783317|NCT03377790|EG000|Reported Event|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions"
10783318|NCT03377790|EG001|Reported Event|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions"
10783319|NCT03353675|BG000|Baseline|TG4010/Chemotherapy/Nivolumab|"TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks~Chemotherapy: Pemetrexed/Cisplatin or Carboplatin~Pemetrexed maintenance~Nivolumab: 360 mg IV administration every 3 weeks"
10783320|NCT03353675|FG000|Participant Flow|TG4010/Chemotherapy/Nivolumab|"TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks~Chemotherapy: Pemetrexed/Cisplatin or Carboplatin~Pemetrexed maintenance~Nivolumab: 360 mg IV administration every 3 weeks"
10783321|NCT03353675|OG000|Outcome|TG4010/Chemotherapy/Nivolumab|"TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks~Chemotherapy: Pemetrexed/Cisplatin or Carboplatin~Pemetrexed maintenance~Nivolumab: 360 mg IV administration every 3 weeks"
10783322|NCT03353675|EG000|Reported Event|TG4010/Chemotherapy/Nivolumab|"TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks~Chemotherapy: Pemetrexed/Cisplatin or Carboplatin~Pemetrexed maintenance~Nivolumab: 360 mg IV administration every 3 weeks"
10783323|NCT03294109|BG000|Baseline|Study|ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine
10783324|NCT03294109|BG001|Baseline|Control|ERAS Plus laparoscopic TAP block
10783325|NCT03294109|BG002|Baseline|Total|Total of all reporting groups
10783326|NCT03294109|FG000|Participant Flow|Study|ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:
10783327|NCT03294109|FG001|Participant Flow|Control|ERAS Plus laparoscopic TAP block
10783328|NCT03294109|OG000|Outcome|Study|ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine
10783329|NCT03294109|OG001|Outcome|Control|ERAS Plus laparoscopic TAP block
10783330|NCT03294109|OG000|Outcome|Study|ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:
10783331|NCT03294109|EG000|Reported Event|Study|ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine
10783332|NCT03294109|EG001|Reported Event|Control|ERAS Plus laparoscopic TAP block
10783333|NCT03268005|BG000|Baseline|Faster Aspart|Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10850630|NCT00303667|OG000|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
10783334|NCT03268005|BG001|Baseline|NovoRapid|Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783335|NCT03268005|BG002|Baseline|Total|Total of all reporting groups
10783336|NCT03268005|FG000|Participant Flow|Faster Aspart|Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783337|NCT03268005|FG001|Participant Flow|NovoRapid|Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783338|NCT03268005|OG000|Outcome|Faster Aspart|Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783339|NCT03268005|OG001|Outcome|NovoRapid|Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783340|NCT03268005|EG000|Reported Event|Faster Aspart|Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783341|NCT03268005|EG001|Reported Event|NovoRapid|Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
10783342|NCT03225170|BG000|Baseline|Self-affirmation (SA) Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;~6-item standardized measure of anxiety questionnaire;~after the genetic counseling session, clients were required to fill out a post session questionnaire"
11194066|NCT02150213|FG000|Participant Flow|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
11194067|NCT02150213|OG000|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
10783343|NCT03225170|BG001|Baseline|Control Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;~6-item standardized measure of anxiety questionnaire;~after the genetic counseling session, clients were required to fill out a post session questionnaire"
10783344|NCT03225170|BG002|Baseline|Genetic Counselor (GC)|"Genetic Counselors (GC) provided their Standard of Care treatment, blinded to clients' enrollment in SA intervention or Control group and assessed each client's empowerment at the end of each session.~GC also completed a survey at the end of the study to assess the writing exercise and the feasibility of SA for larger studies."
10783345|NCT03225170|BG003|Baseline|Total|Total of all reporting groups
10783346|NCT03225170|FG000|Participant Flow|Self-affirmation (SA) Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;~6-item standardized measure of anxiety questionnaire;~after the genetic counseling session, clients were required to fill out a post session questionnaire"
10783347|NCT03225170|FG001|Participant Flow|Control Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;~6-item standardized measure of anxiety questionnaire;~after the genetic counseling session, clients were required to fill out a post session questionnaire"
10783348|NCT03225170|FG002|Participant Flow|Genetic Counselor (GC)|"Genetic Counselors (GC) provided their Standard of Care treatment, blinded to clients' enrollment in SA intervention or Control group and assessed each client's empowerment at the end of each session.~GC also completed a survey at the end of the study to assess the writing exercise and the feasibility of SA for larger studies."
10783349|NCT03225170|OG000|Outcome|Self-affirmation (SA) Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;~6-item standardized measure of anxiety questionnaire;~after the counseling session, clients were required to fill out a post session questionnaire"
10783350|NCT03225170|OG001|Outcome|Control Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;~6-item standardized measure of anxiety questionnaire;~after the genetic counseling session, clients were required to fill out a post session questionnaire"
10783351|NCT03225170|EG000|Reported Event|Self-affirmation (SA) Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;~6-item standardized measure of anxiety questionnaire;~after the counseling session, clients were required to fill out a post session questionnaire"
10783352|NCT03225170|EG001|Reported Event|Control Group|"Immediately prior to the scheduled cancer genetic counseling appointment, clients:~completed similar standardized questionnaire as the SA group, but was a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;~6-item standardized measure of anxiety questionnaire;~after the counseling session, clients were required to fill out a post session questionnaire"
10783353|NCT03220854|BG000|Baseline|A: Patients Receiving SBRT (Body) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783354|NCT03220854|BG001|Baseline|B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783355|NCT03220854|BG002|Baseline|C: Patients Receiving SRS (Brain) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
11194068|NCT02150213|EG000|Reported Event|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
10783356|NCT03220854|BG003|Baseline|Total|Total of all reporting groups
10783357|NCT03220854|FG000|Participant Flow|A: Patients Receiving SBRT (Body) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783358|NCT03220854|FG001|Participant Flow|B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783359|NCT03220854|FG002|Participant Flow|C: Patients Receiving SRS (Brain) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783360|NCT03220854|OG000|Outcome|A: SBRT (Body) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783361|NCT03220854|OG001|Outcome|B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783362|NCT03220854|OG002|Outcome|C: Patients Receiving SRS (Brain) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783363|NCT03220854|OG000|Outcome|A: Patients Receiving SBRT (Body) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783364|NCT03220854|OG001|Outcome|B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783365|NCT03220854|OG002|Outcome|C: Patients Receiving SRS (Brain) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783366|NCT03220854|EG000|Reported Event|A: Patients Receiving SBRT (Body) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations
10783367|NCT03220854|EG001|Reported Event|B: Patients Receiving SBRT and SRS (Body and Brain) Irradiation|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783368|NCT03220854|EG002|Reported Event|C: Patients Receiving SRS (Brain) Irradiation Only|Patients will receive a standard treatment regimen of SRT (refer to Section 6.3). The term SRT encompasses all radiotherapy using a stereotactic setup, both stereotactic radiosurgery (SRS) for metastatic lesions in the brain and stereotactic body radiotherapy (SBRT) for SRT delivered to all other locations.
10783369|NCT03219034|BG000|Baseline|Oral Appliance Sequence - A -- B|"Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX. One week washout with no oral appliance usage.~Used Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX."
10783370|NCT03219034|BG001|Baseline|Oral Appliance Sequence B -- A|"Group STARTING with Appliance B for first leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX. One week washout with no oral appliance usage.~Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX"
10783371|NCT03219034|BG002|Baseline|Total|Total of all reporting groups
10801817|NCT03930446|BG000|Baseline|Ethanol|"Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).~Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water"
11194069|NCT02150343|BG000|Baseline|HDM-SPIRE 12 Nmol (4 Administrations)|12 nmol given at 4 weekly intervals (4 administrations)
10783372|NCT03219034|FG000|Participant Flow|Oral Appliance Sequence A-B|"Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.~Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX~Used Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.~Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX"
10783373|NCT03219034|FG001|Participant Flow|Oral Appliance Sequence B-A|"Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.~Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX~Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.~Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX"
10783374|NCT03219034|OG000|Outcome|Oral Appliance Sequence - A -- B|"Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.~Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX.~1 week washout followed by Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.~Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX"
10783375|NCT03219034|OG001|Outcome|Oral Appliance Sequence B -- A|"Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.~Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.~Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX"
10783376|NCT03219034|OG000|Outcome|Oral Appliance Sequence - A -- B|"Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.~Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX"
10783377|NCT03219034|OG001|Outcome|Oral Appliance Sequence B-A|"Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.~Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX"
10783378|NCT03219034|EG000|Reported Event|Oral Appliance A|"Oral Appliance A - Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX. Worn for 4 weeks."
10783379|NCT03219034|EG001|Reported Event|Oral Appliance B|"Oral Appliance B: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX. Worn for 4 weeks."
10783380|NCT03168438|BG000|Baseline|GSK3377794|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
10783381|NCT03168438|BG001|Baseline|GSK3377794+Pembrolizumab|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
10783382|NCT03168438|BG002|Baseline|Total|Total of all reporting groups
10783383|NCT03168438|FG000|Participant Flow|GSK3377794|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
10783384|NCT03168438|FG001|Participant Flow|GSK3377794+Pembrolizumab|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
10783385|NCT03168438|OG000|Outcome|GSK3377794|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
11194070|NCT02150343|BG001|Baseline|HDM-SPIRE 20 Nmol|20 nmol given at 4 weekly intervals (4 administrations)
11194071|NCT02150343|BG002|Baseline|HDM-SPIRE 12 Nmol (8 Administrations)|20 nmol given at 4 weekly intervals (8 administrations)
11194072|NCT02150343|BG003|Baseline|HDM-SPIRE Placebo|8 administrations at 4 weekly intervals
11194073|NCT02150343|BG004|Baseline|Total|Total of all reporting groups
10783386|NCT03168438|OG001|Outcome|GSK3377794+Pembrolizumab|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
10783387|NCT03168438|OG000|Outcome|GSK3377794+Pembrolizumab|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
10783388|NCT03168438|EG000|Reported Event|GSK3377794|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
10783389|NCT03168438|EG001|Reported Event|GSK3377794+Pembrolizumab|Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
10783390|NCT03110380|BG000|Baseline|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783391|NCT03110380|BG001|Baseline|DTG + F/TAF|DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783392|NCT03110380|BG002|Baseline|Total|Total of all reporting groups
10783393|NCT03110380|FG000|Participant Flow|B/F/TAF|Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783394|NCT03110380|FG001|Participant Flow|DTG + F/TAF|DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783395|NCT03110380|FG002|Participant Flow|B/F/TAF From B/F/TAF|Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
10783396|NCT03110380|FG003|Participant Flow|B/F/TAF From DTG + F/TAF|Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
10783397|NCT03110380|OG000|Outcome|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783398|NCT03110380|OG001|Outcome|DTG + F/TAF|DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
10783399|NCT03110380|EG000|Reported Event|Double-Blind Treatment Phase B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.
10783400|NCT03110380|EG001|Reported Event|Double-Blind Treatment Phase DTG + F/TAF|DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.
10783401|NCT03110380|EG002|Reported Event|Open-label Extension Phase B/F/TAF From B/F/TAF|Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
10783402|NCT03110380|EG003|Reported Event|Open-label Extension Phase B/F/TAF From DTG + F/TAF|Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
10966603|NCT00887744|BG000|Baseline|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
10801818|NCT03930446|BG001|Baseline|Placebo (Juice)|"Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).~Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent."
10801819|NCT03930446|BG002|Baseline|Total|Total of all reporting groups
10801820|NCT03930446|FG000|Participant Flow|Ethanol|"Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).~Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water"
10801821|NCT03930446|FG001|Participant Flow|Placebo (Juice)|"Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).~Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent."
10801822|NCT03930446|OG000|Outcome|Ethanol|"Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).~Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water"
10801823|NCT03930446|OG001|Outcome|Placebo (Juice)|"Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).~Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent."
10783403|NCT03109262|BG000|Baseline|Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans|"All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans~Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.~Positron Emission Tomography (PET): As part of PET/CT scan~Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan~90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan~Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan"
10783404|NCT03109262|FG000|Participant Flow|Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans|"All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans~Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.~Positron Emission Tomography (PET): As part of PET/CT scan~Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan~90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan~Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan"
10783405|NCT03109262|OG000|Outcome|Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans|"All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans~Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.~Positron Emission Tomography (PET): As part of PET/CT scan~Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan~90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan~Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan"
10783406|NCT03109262|OG000|Outcome|Yttrium Y-90 PET/CT|"All participants receive Y-90 PET/CT Scan~Computed Tomography (CT): As part of PET/CT scan. Positron Emission Tomography (PET): As part of PET/CT scan~90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan"
10783407|NCT03109262|OG001|Outcome|99mTc-MAA SPECT/CT Scans|"All participants receive 99mTc-MAA SPECT/CT scan~Computed Tomography (CT): As part of SPECT/CT scans. Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan~Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan"
10783408|NCT03109262|EG000|Reported Event|Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans|"All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans~Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.~Positron Emission Tomography (PET): As part of PET/CT scan~Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan~90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan~Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan"
10783409|NCT03078478|BG000|Baseline|Insulin Degludec U200|Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783410|NCT03078478|BG001|Baseline|Insulin Glargine U300|Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783411|NCT03078478|BG002|Baseline|Total|Total of all reporting groups
10783412|NCT03078478|FG000|Participant Flow|Insulin Degludec U200|Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783413|NCT03078478|FG001|Participant Flow|Insulin Glargine U300|Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783414|NCT03078478|OG000|Outcome|Insulin Degludec 200|Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783415|NCT03078478|OG001|Outcome|Insulin Glargine U300|Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783416|NCT03078478|EG000|Reported Event|IDeg U200|Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10966604|NCT00887744|FG000|Participant Flow|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
10783417|NCT03078478|EG001|Reported Event|IGlar U300|Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
10783418|NCT03040661|BG000|Baseline|Figure of 8 Suture|"Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.~Ablation for atrial fibrillation.: Ablation for atrial fibrillation."
10783419|NCT03040661|BG001|Baseline|Manual Hemostasis Group|"Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.~Ablation for atrial fibrillation.: Ablation for atrial fibrillation."
10783420|NCT03040661|BG002|Baseline|Total|Total of all reporting groups
10783421|NCT03040661|FG000|Participant Flow|Figure of 8 Suture|"Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.~Ablation for atrial fibrillation.: Ablation for atrial fibrillation."
10783422|NCT03040661|FG001|Participant Flow|Manual Hemostasis Group|"Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.~Ablation for atrial fibrillation.: Ablation for atrial fibrillation."
10783423|NCT03040661|OG000|Outcome|Figure of 8 Suture|"Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.~Ablation for atrial fibrillation."
10783424|NCT03040661|OG001|Outcome|Manual Hemostasis Group|"Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.~Ablation for atrial fibrillation"
10783425|NCT03040661|EG000|Reported Event|Figure of 8 Suture|"Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.~Ablation for atrial fibrillation."
10783426|NCT03040661|EG001|Reported Event|Manual Hemostasis Group|"Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.~Ablation for atrial fibrillation"
10783427|NCT02993263|BG000|Baseline|Noncardiac Surgery|VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
10783428|NCT02993263|FG000|Participant Flow|Noncardiac Surgery|VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
10783429|NCT02993263|OG000|Outcome|Noncardiac Surgery|VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
10783430|NCT02993263|EG000|Reported Event|Noncardiac Surgery|VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
10783431|NCT02985684|BG000|Baseline|Device|"ASD closure with the GORE® CARDIOFORM ASD Occluder~GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure"
10783432|NCT02985684|FG000|Participant Flow|Device|"ASD closure with the GORE® CARDIOFORM ASD Occluder~GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure"
10783433|NCT02985684|OG000|Outcome|Device|"ASD closure with the GORE® CARDIOFORM ASD Occluder~GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure"
10783434|NCT02985684|EG000|Reported Event|Device|"ASD closure with the GORE® CARDIOFORM ASD Occluder~GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure"
10783435|NCT02964897|BG000|Baseline|Intervention Arm With Peer Support|"Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.~Peer-support plus usual care from the Health Care for Reentry Veterans program: a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program."
10783436|NCT02964897|BG001|Baseline|Comparison Arm With Usual Care|"Veterans in this arm will be receiving usual care from the Health Care for Reentry Veterans program (but they will not receive the peer-support intervention). They will be selected to be frequency-matched to veterans in the intervention arm by date of release from incarceration.~Usual care from the Health Care for Reentry Veterans program: Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc."
10783437|NCT02964897|BG002|Baseline|Total|Total of all reporting groups
10783438|NCT02964897|FG000|Participant Flow|Intervention Arm With Peer Support|"Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.~Peer-support plus usual care from the Health Care for Reentry Veterans program: a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program."
10783439|NCT02964897|FG001|Participant Flow|Comparison Arm With Usual Care|"Veterans in this arm will be receiving usual care from the Health Care for Reentry Veterans program (but they will not receive the peer-support intervention). They will be selected to be frequency-matched to veterans in the intervention arm by date of release from incarceration.~Usual care from the Health Care for Reentry Veterans program: Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc."
10783440|NCT02964897|OG000|Outcome|Intervention Arm With Peer Support|"Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.~Peer-support plus usual care from the Health Care for Reentry Veterans program: a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program."
11194074|NCT02150343|FG000|Participant Flow|HDM-SPIRE 12 Nmol (4 Administrations)|12 nmol given at 4 weekly intervals (4 administrations)
10783441|NCT02964897|OG001|Outcome|Comparison Arm With Usual Care|"Veterans in this arm will be receiving usual care from the Health Care for Reentry Veterans program (but they will not receive the peer-support intervention). They will be selected to be frequency-matched to veterans in the intervention arm by date of release from incarceration.~Usual care from the Health Care for Reentry Veterans program: Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc."
10783442|NCT02964897|EG000|Reported Event|Intervention Arm With Peer Support|"Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.~Peer-support plus usual care from the Health Care for Reentry Veterans program: a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program."
10783443|NCT02964897|EG001|Reported Event|Comparison Arm With Usual Care|"Veterans in this arm will be receiving usual care from the Health Care for Reentry Veterans program (but they will not receive the peer-support intervention). They will be selected to be frequency-matched to veterans in the intervention arm by date of release from incarceration.~Usual care from the Health Care for Reentry Veterans program: Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc."
10783444|NCT02873195|BG000|Baseline|Atezolizumab, Bevacizumab, Capecitabine|Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783445|NCT02873195|BG001|Baseline|Placebo, Bevacizumab, Capecitabine|Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11194075|NCT02150343|FG001|Participant Flow|HDM-SPIRE 20 Nmol|20 nmol given at 4 weekly intervals (4 administrations)
10783446|NCT02873195|BG002|Baseline|Total|Total of all reporting groups
10783447|NCT02873195|FG000|Participant Flow|Atezolizumab, Bevacizumab, Capecitabine|Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783448|NCT02873195|FG001|Participant Flow|Placebo, Bevacizumab, Capecitabine|Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783449|NCT02873195|OG000|Outcome|Atezolizumab, Bevacizumab, Capecitabine|Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783450|NCT02873195|OG001|Outcome|Placebo, Bevacizumab, Capecitabine|Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783451|NCT02873195|EG000|Reported Event|Atezolizumab, Bevacizumab, Capecitabine|Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783452|NCT02873195|EG001|Reported Event|Placebo, Bevacizumab, Capecitabine|Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10783453|NCT02809131|BG000|Baseline|Saline Irrigation|Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783454|NCT02809131|BG001|Baseline|Antibiotic Irrigation and Oral Antibiotics|Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783455|NCT02809131|BG002|Baseline|Total|Total of all reporting groups
10783456|NCT02809131|FG000|Participant Flow|Saline Irrigation|Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783457|NCT02809131|FG001|Participant Flow|Antibiotic Irrigation and Oral Antibiotics|Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783458|NCT02809131|OG000|Outcome|Saline Irrigation|Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783459|NCT02809131|OG001|Outcome|Antibiotic Irrigation and Oral Antibiotics|Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
11194076|NCT02150343|FG002|Participant Flow|HDM-SPIRE 12 Nmol (8 Administrations)|20 nmol given at 4 weekly intervals (8 administrations)
11194077|NCT02150343|FG003|Participant Flow|HDM-SPIRE Placebo|8 administrations at 4 weekly intervals
11194078|NCT02150343|OG000|Outcome|HDM-SPIRE 12 Nmol (4 Administrations)|12 nmol given at 4 weekly intervals (4 administrations)
10783460|NCT02809131|EG000|Reported Event|Saline Irrigation|Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783461|NCT02809131|EG001|Reported Event|Antibiotic Irrigation and Oral Antibiotics|Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
10783462|NCT02785952|BG000|Baseline|Arm I (Nivolumab, Ipilimumab)|"Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783463|NCT02785952|BG001|Baseline|Arm II (Nivolumab)|"Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783464|NCT02785952|BG002|Baseline|Total|Total of all reporting groups
10783465|NCT02785952|FG000|Participant Flow|Arm I (Nivolumab, Ipilimumab)|"Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783466|NCT02785952|FG001|Participant Flow|Arm II (Nivolumab)|"Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783467|NCT02785952|OG000|Outcome|Arm I (Nivolumab, Ipilimumab)|"Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783468|NCT02785952|OG001|Outcome|Arm II (Nivolumab)|"Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10783469|NCT02785952|OG000|Outcome|Nivolumab + Ipilimumab|"Participants receive nivolumab on day 1 of each 14-day cycle and ipilimumab on day 1 of every third cycle beginning with cycle 1.~Nivolumab: Given IV Durvalumab: Given IV"
10783470|NCT02785952|OG001|Outcome|Nivolumab|"Participants receive nivolumab on day 1 of each 14-day cycle.~Nivolumab: Given IV."
10783471|NCT02785952|EG000|Reported Event|Nivolumab + Ipilimumab|"Participants receive nivolumab on day 1 of each 14-day cycle and ipilimumab on day 1 of every third cycle beginning with cycle 1.~Nivolumab: Given IV Durvalumab: Given IV"
10783472|NCT02785952|EG001|Reported Event|Nivolumab|"Participants receive nivolumab on day 1 of each 14-day cycle.~Nivolumab: Given IV."
10783473|NCT02758717|BG000|Baseline|Treatment (Brentuximab Vedotin, Nivolumab)|Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
10783474|NCT02758717|FG000|Participant Flow|Treatment (Brentuximab Vedotin, Nivolumab)|Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
10783475|NCT02758717|OG000|Outcome|Treatment (Brentuximab Vedotin, Nivolumab)|Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
10783476|NCT02758717|EG000|Reported Event|Treatment (Brentuximab Vedotin, Nivolumab)|Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
10783477|NCT02748616|BG000|Baseline|Ursodiol|"Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.~Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks."
10783478|NCT02748616|FG000|Participant Flow|Ursodiol|"Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.~Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks."
10783479|NCT02748616|OG000|Outcome|Ursodiol|"Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.~Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks."
10783480|NCT02748616|EG000|Reported Event|Ursodiol|"Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.~Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks."
10783481|NCT02719522|BG000|Baseline|Intention to Treat (ITT)|Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
11194079|NCT02150343|OG001|Outcome|HDM-SPIRE 20 Nmol|20 nmol given at 4 weekly intervals (4 administrations)
11194080|NCT02150343|OG002|Outcome|HDM-SPIRE 12 Nmol (8 Administrations)|20 nmol given at 4 weekly intervals (8 administrations)
10783482|NCT02719522|FG000|Participant Flow|Intention to Treat (ITT)|Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
10783483|NCT02719522|OG000|Outcome|Intention to Treat (ITT)|Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
10783484|NCT02719522|EG000|Reported Event|Intention to Treat (ITT)|Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
10783485|NCT02664181|BG000|Baseline|Oral THU/Decitabine + Nivolumab|"Oral THU ~10 mg/kg, followed by oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression~oral decitabine: oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.~Tetrahydrouridine: Oral THU ~10 mg/kg twice weekly on consecutive days"
10783486|NCT02664181|BG001|Baseline|Nivolumab|"Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression"
10783487|NCT02664181|BG002|Baseline|Total|Total of all reporting groups
10783488|NCT02664181|FG000|Participant Flow|Oral THU/Decitabine + Nivolumab|"Oral THU ~10 mg/kg, followed by oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression~oral decitabine: oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.~Tetrahydrouridine: Oral THU ~10 mg/kg twice weekly on consecutive days"
10783489|NCT02664181|FG001|Participant Flow|Nivolumab|"Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression"
11194081|NCT02150343|OG003|Outcome|HDM-SPIRE Placebo|8 administrations at 4 weekly intervals
10783490|NCT02664181|OG000|Outcome|Nivolumab|"Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression"
10783491|NCT02664181|OG001|Outcome|Oral THU/Decitabine + Nivolumab|"Oral THU ~10 mg/kg, followed by oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression~oral decitabine: oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.~Tetrahydrouridine: Oral THU ~10 mg/kg twice weekly on consecutive days"
10783492|NCT02664181|EG000|Reported Event|Oral THU/Decitabine + Nivolumab|"Oral THU ~10 mg/kg, followed by oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression~oral decitabine: oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.~Tetrahydrouridine: Oral THU ~10 mg/kg twice weekly on consecutive days"
10783493|NCT02664181|EG001|Reported Event|Nivolumab|"Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.~Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression"
10783494|NCT02633241|BG000|Baseline|Dexmedetomidine-Propofol Arm|The investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
11194082|NCT02150343|EG000|Reported Event|HDM-SPIRE 12 Nmol (4 Administrations)|12 nmol given at 4 weekly intervals (4 administrations)
10783495|NCT02633241|FG000|Participant Flow|Dexmedetomidine-Propofol Arm|"Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.~Dexmedetomidine-Propofol: First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes."
11194083|NCT02150343|EG001|Reported Event|HDM-SPIRE 20 Nmol|20 nmol given at 4 weekly intervals (4 administrations)
11194084|NCT02150343|EG002|Reported Event|HDM-SPIRE 12 Nmol (8 Administrations)|20 nmol given at 4 weekly intervals (8 administrations)
11194085|NCT02150343|EG003|Reported Event|HDM-SPIRE Placebo|8 administrations at 4 weekly intervals
11194086|NCT02150460|BG000|Baseline|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
11194087|NCT02150460|BG001|Baseline|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
11194088|NCT02150460|BG002|Baseline|Total|Total of all reporting groups
11194089|NCT02150460|FG000|Participant Flow|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
11380671|NCT02348216|BG005|Baseline|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR Tcells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380672|NCT02348216|BG006|Baseline|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380673|NCT02348216|BG007|Baseline|Total|Total of all reporting groups
11380674|NCT02348216|FG000|Participant Flow|Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy|Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m^2 intravenously [IV] over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight (BW) (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380675|NCT02348216|FG001|Participant Flow|Phase 2 (Pivotal Study): Cohort 1|Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380676|NCT02348216|FG002|Participant Flow|Phase 2 (Pivotal Study): Cohort 2|Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11194090|NCT02150460|FG001|Participant Flow|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
11194091|NCT02150460|OG000|Outcome|Group 1|One-site peribulbar injection
11194092|NCT02150460|OG001|Outcome|Group 2|Two-site peribulbar injection
11194093|NCT02150460|EG000|Reported Event|Group 1|One-site peribulbar injection
11194094|NCT02150460|EG001|Reported Event|Group 2|Two-site peribulbar injection
11194095|NCT02150499|BG000|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
11380677|NCT02348216|FG003|Participant Flow|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV twice daily [BID]) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
11380678|NCT02348216|FG004|Participant Flow|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of investigator and could include: dexamethasone 20 mg to 40 mg or equivalent, either oral administration (PO) or IV daily for 1 to 4 days; or 1 g/m^2 of high-dose methylprednisolone (HDMP) for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2) and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380679|NCT02348216|FG005|Participant Flow|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380680|NCT02348216|FG006|Participant Flow|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380681|NCT02348216|OG000|Outcome|Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy|Participants with DLBCL, primary PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380682|NCT02348216|OG000|Outcome|Phase 2 (Pivotal Study): Cohort 1|Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11194096|NCT02150499|BG001|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
11194097|NCT02150499|BG002|Baseline|Total|Total of all reporting groups
10783496|NCT02633241|OG000|Outcome|Dexmedetomidine-Propofol Arm|First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
10783497|NCT02633241|OG000|Outcome|Dexmedetomidine-Propofol Arm|"Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.~Dexmedetomidine-Propofol: First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure."
10783498|NCT02633241|OG000|Outcome|Dexmedetomidine-Propofol Arm|"Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.~Dexmedetomidine-Propofol: The investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minutes, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine if the child is in an adequate state to begin the MRI scan. If the child is not sufficiently sedated within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist."
10783499|NCT02633241|EG000|Reported Event|Dexmedetomidine-Propofol Arm|"Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.~Dexmedetomidine-Propofol: First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure."
10783500|NCT02585232|BG000|Baseline|Care Consultation (CC)|"Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment - much like an interview guide - which then immediately shapes development of concrete action plans.~Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment, which then immediately shapes development of concrete action plans."
10783501|NCT02585232|BG001|Baseline|Care Consultation + Counseling (CC+C)|"Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework.~Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.)."
10783502|NCT02585232|BG002|Baseline|Total|Total of all reporting groups
10850631|NCT00303667|OG001|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
11194098|NCT02150499|FG000|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
10783503|NCT02585232|FG000|Participant Flow|Care Consultation (CC)|"Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment - much like an interview guide - which then immediately shapes development of concrete action plans.~Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment, which then immediately shapes development of concrete action plans."
10783504|NCT02585232|FG001|Participant Flow|Care Consultation + Counseling (CC+C)|"Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework.~Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.)."
10783505|NCT02585232|OG000|Outcome|Care Consultation (CC)|"Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment - much like an interview guide - which then immediately shapes development of concrete action plans.~Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment, which then immediately shapes development of concrete action plans."
10783506|NCT02585232|OG001|Outcome|Care Consultation + Counseling (CC+C)|"Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework.~Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.)."
10801824|NCT03930446|EG000|Reported Event|Ethanol|"Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).~Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water"
10801825|NCT03930446|EG001|Reported Event|Placebo (Juice)|"Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).~Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent."
10801826|NCT03492099|BG000|Baseline|Buprenorphine Arm|"This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.~buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient."
11194099|NCT02150499|FG001|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
11194100|NCT02150499|OG000|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
11194101|NCT02150499|OG001|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
10783507|NCT02585232|EG000|Reported Event|Care Consultation (CC)|"Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment - much like an interview guide - which then immediately shapes development of concrete action plans.~Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment, which then immediately shapes development of concrete action plans."
10783508|NCT02585232|EG001|Reported Event|Care Consultation + Counseling (CC+C)|"Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework.~Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.)."
10783509|NCT02583269|BG000|Baseline|Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783510|NCT02583269|BG001|Baseline|Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783511|NCT02583269|BG002|Baseline|Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783512|NCT02583269|BG003|Baseline|Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783513|NCT02583269|BG004|Baseline|Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783514|NCT02583269|BG005|Baseline|Total|Total of all reporting groups
10783515|NCT02583269|FG000|Participant Flow|Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783516|NCT02583269|FG001|Participant Flow|Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783517|NCT02583269|FG002|Participant Flow|Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783518|NCT02583269|FG003|Participant Flow|Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783519|NCT02583269|FG004|Participant Flow|Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783520|NCT02583269|OG000|Outcome|Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783521|NCT02583269|OG001|Outcome|Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783522|NCT02583269|OG002|Outcome|Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783523|NCT02583269|OG003|Outcome|Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
11194102|NCT02150499|EG000|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
11194103|NCT02150499|EG001|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
10783524|NCT02583269|OG004|Outcome|Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783525|NCT02583269|OG000|Outcome|Treatment (Muscadine Grape Skin Extract) FOR ALL ARMS|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783526|NCT02583269|EG000|Reported Event|Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783527|NCT02583269|EG001|Reported Event|Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO~Quality-of-Life Assessment: Ancillary studies"
10783528|NCT02583269|EG002|Reported Event|Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO"
10783529|NCT02583269|EG003|Reported Event|Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO"
10966605|NCT00887744|OG000|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
10966606|NCT00887744|EG000|Reported Event|ITT Analysis|Single group - Aperius
11194104|NCT02150759|BG000|Baseline|Dexmedetomidine-Ketamine|Dexmedetomidine-Ketamine combination
11194105|NCT02150759|BG001|Baseline|Dexmedetomidine-Fentanyl|Dexmedetomidine-Fentanyl combination
11194106|NCT02150759|BG002|Baseline|Total|Total of all reporting groups
10783530|NCT02583269|EG004|Reported Event|Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day|"Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Muscadine Grape Skin Extract: Given PO"
10783531|NCT02556606|BG000|Baseline|Ketamine 0.10 mg/kg|randomly assigned to a single 40 min infusion of KET 0.1 mg/kg
10783532|NCT02556606|BG001|Baseline|Ketamine 0.25 mg/kg|randomly assigned to a single 40 min infusion of KET 0.25 mg/kg
10783533|NCT02556606|BG002|Baseline|Ketamine 0.50 mg/kg|randomly assigned to a single 40 min infusion of KET 0.50 mg/kg
10783534|NCT02556606|BG003|Baseline|Midazolam 0.03 mg/kg|randomly assigned to a single 40 min infusion of MID 0.03 mg/kg
10783535|NCT02556606|BG004|Baseline|Total|Total of all reporting groups
10783536|NCT02556606|FG000|Participant Flow|Ketamine 0.10 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg"
10783537|NCT02556606|FG001|Participant Flow|Ketamine 0.25 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg"
10783538|NCT02556606|FG002|Participant Flow|Ketamine 0.50 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg"
10783539|NCT02556606|FG003|Participant Flow|Midazolam 0.03 mg/kg|"randomly assigned to a single 40 min infusion of either MID 0.03mg/Kg~Midazolam: single 40 min infusion of MID 0.03mg/Kg"
10783540|NCT02556606|OG000|Outcome|Ketamine 0.10 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg"
10783541|NCT02556606|OG001|Outcome|Ketamine 0.25 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg"
10783542|NCT02556606|OG002|Outcome|Ketamine 0.50 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg"
10783543|NCT02556606|OG003|Outcome|Midazolam 0.03 mg/kg|"randomly assigned to a single 40 min infusion of either MID 0.03mg/Kg~Midazolam: single 40 min infusion of MID 0.03mg/Kg"
10783544|NCT02556606|OG000|Outcome|Ketamine 0.10 mg/kg|randomly assigned to a single 40 min infusion of KET 0.1 mg/kg
10783545|NCT02556606|OG001|Outcome|Ketamine 0.25 mg/kg|randomly assigned to a single 40 min infusion of KET 0.25 mg/kg
10783546|NCT02556606|OG002|Outcome|Ketamine 0.50 mg/kg|randomly assigned to a single 40 min infusion of KET 0.50 mg/kg
10783547|NCT02556606|OG003|Outcome|Midazolam 0.03 mg/kg|randomly assigned to a single 40 min infusion of MID 0.03 mg/kg
10783548|NCT02556606|EG000|Reported Event|Ketamine 0.10 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg"
10783549|NCT02556606|EG001|Reported Event|Ketamine 0.25 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg"
10783550|NCT02556606|EG002|Reported Event|Ketamine 0.50 mg/kg|"randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg~Ketamine: randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg"
10783551|NCT02556606|EG003|Reported Event|Midazolam 0.03 mg/kg|"randomly assigned to a single 40 min infusion of either MID 0.03mg/Kg~Midazolam: single 40 min infusion of MID 0.03mg/Kg"
10783552|NCT02545283|BG000|Baseline|Placebo Plus Cytarabine|Participants received induction therapy idasanutlin matching placebo and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
10783553|NCT02545283|BG001|Baseline|Idasanutlin Plus Cytarabine|Participants received induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
10783554|NCT02545283|BG002|Baseline|Total|Total of all reporting groups
10783555|NCT02545283|FG000|Participant Flow|Placebo Plus Cytarabine|Participants received induction therapy idasanutlin matching placebo and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
10783556|NCT02545283|FG001|Participant Flow|Idasanutlin Plus Cytarabine|Participants received induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
10783557|NCT02545283|OG000|Outcome|Placebo Plus Cytarabine|Participants received induction therapy idasanutlin matching placebo and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
10966607|NCT00887809|BG000|Baseline|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
10783558|NCT02545283|OG001|Outcome|Idasanutlin Plus Cytarabine|Participants received induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
10783559|NCT02545283|OG000|Outcome|Idasanutlin Plus Cytarabine|Participants received induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
10783560|NCT02545283|OG001|Outcome|Placebo Plus Cytarabine|Participants received induction therapy idasanutlin matching placebo and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
10783561|NCT02545283|EG000|Reported Event|Idasanutlin-Cytarabine|Participants will receive induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed
10783562|NCT02545283|EG001|Reported Event|Placebo-Cytarabine|Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
10801827|NCT03492099|FG000|Participant Flow|Buprenorphine Arm|"This is the main and only arm of the study. This was an observational trial in which patients who were converted to buprenorphine had data collected on hospital utilization before and after conversion to buprenorphine and filled out surveys listed in secondary outcomes.~buprenorphine: As this was part of clinical care individual dosages were dependent on prior opioid exposure and patient characteristics."
10801828|NCT03492099|OG000|Outcome|Buprenorphine Arm|"This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.~buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient."
10801829|NCT03492099|OG000|Outcome|Buprenorphine Arm|"This is the main and only arm of the study. This was an observational trial in which patients who were converted to buprenorphine had data collected on hospital utilization before and after conversion to buprenorphine and filled out surveys listed in secondary outcomes.~buprenorphine: As this was part of clinical care individual dosages were dependent on prior opioid exposure and patient characteristics."
10801830|NCT03492099|EG000|Reported Event|Buprenorphine Arm|"This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.~buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient."
10803745|NCT02134028|BG003|Baseline|Participants From EFC13579: Dupilumab/Dupilumab|Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803746|NCT02134028|BG004|Baseline|Participants From EFC13691: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803747|NCT02134028|BG005|Baseline|Participants From EFC13691: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803748|NCT02134028|BG006|Baseline|Participants From PDY14192: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803749|NCT02134028|BG007|Baseline|Participants From PDY14192: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803750|NCT02134028|BG008|Baseline|Total|Total of all reporting groups
10850632|NCT00303667|EG000|Reported Event|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
11194107|NCT02150759|FG000|Participant Flow|Dexmedetomidine-ketamine|"Dexmedetomidine-ketamine group~Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia~Ketamine: add dexmedetomidine during position change"
10783563|NCT02524171|BG000|Baseline|Moral Reconation Therapy (MRT)|"MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.~Moral Reconation Therapy (MRT): MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program."
10783564|NCT02524171|BG001|Baseline|Usual Care (UC)|Usual care provided by the mental health residential rehabilitation treatment programs, which patients in both groups are in.
10783565|NCT02524171|BG002|Baseline|Total|Total of all reporting groups
10783566|NCT02524171|FG000|Participant Flow|Moral Reconation Therapy (MRT)|"MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.~Moral Reconation Therapy (MRT): MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program."
11194108|NCT02150759|FG001|Participant Flow|Dexmedetomidine-fentanyl|"Dexmedetomidine-fentanyl group~Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia~Fentanyl: add dexmedetomidine during position change"
11194109|NCT02150759|OG000|Outcome|Dexmedetomidine-ketamine|"Dexmedetomidine-ketamine group~Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia~Ketamine: add dexmedetomidine during position change"
11194110|NCT02150759|OG001|Outcome|Dexmedetomidine-fentanyl|"Dexmedetomidine-fentanyl group~Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia~Fentanyl: add dexmedetomidine during position change"
11194111|NCT02150759|EG000|Reported Event|Dexmedetomidine-Ketamine|Dexmedetomidine-Ketamine combination
11194112|NCT02150759|EG001|Reported Event|Dexmedetomidine-Fentanyl|Dexmedetomidine-Fentanyl combination
11194113|NCT02150837|BG000|Baseline|5 & 2 & 2 Plan|"MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.~5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit."
11194114|NCT02150837|BG001|Baseline|4 & 2 & 1 Plan|"MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.~4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit."
11194115|NCT02150837|BG002|Baseline|Total|Total of all reporting groups
10783567|NCT02524171|FG001|Participant Flow|Usual Care (UC)|Usual care provided by the mental health residential rehabilitation treatment programs, which patients in both groups are in.
10783568|NCT02524171|OG000|Outcome|Moral Reconation Therapy (MRT)|"MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.~Moral Reconation Therapy (MRT): MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program."
10783569|NCT02524171|OG001|Outcome|Usual Care (UC)|Usual care provided by the mental health residential rehabilitation treatment programs, which patients in both groups are in.
10783570|NCT02524171|EG000|Reported Event|Moral Reconation Therapy (MRT)|"MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.~Moral Reconation Therapy (MRT): MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program."
10783571|NCT02524171|EG001|Reported Event|Usual Care (UC)|Usual care provided by the mental health residential rehabilitation treatment programs, which patients in both groups are in.
11338896|NCT03619837|FG000|Participant Flow|Treatment Arm|"Single Arm: Sofosbuvir/Velpatasvir~Dosage: 400mg/100mg. Once daily for 12 weeks.~Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.~Sofosbuvir/Velpatasvir/Voxilaprevir: Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.~Dosage: 400mg/100mg/100mg daily for 12 weeks."
11338897|NCT03619837|OG000|Outcome|Treatment Arm|"Single Arm: Sofosbuvir/Velpatasvir~Dosage: 400mg/100mg. Once daily for 12 weeks.~Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.~Sofosbuvir/Velpatasvir/Voxilaprevir: Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.~Dosage: 400mg/100mg/100mg daily for 12 weeks."
11194116|NCT02150837|FG000|Participant Flow|5 & 2 & 2 Plan|"MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.~5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit."
11194117|NCT02150837|FG001|Participant Flow|4 & 2 & 1 Plan|"MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.~4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit."
10783572|NCT02489422|BG000|Baseline|Group I (Yoga Skills Training)|"Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.~Actigraphy Assessment: Ancillary studies"
10783573|NCT02489422|BG001|Baseline|Group II (Attention Control)|"Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.~Actigraphy Assessment: Ancillary studies"
10783574|NCT02489422|BG002|Baseline|Total|Total of all reporting groups
10783575|NCT02489422|FG000|Participant Flow|Group I (Yoga Skills Training)|"Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.~Actigraphy Assessment: Ancillary studies"
10783576|NCT02489422|FG001|Participant Flow|Group II (Attention Control)|"Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.~Actigraphy Assessment: Ancillary studies"
10783577|NCT02489422|OG000|Outcome|Group I (Yoga Skills Training)|"Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.~Actigraphy Assessment: Ancillary studies"
10966608|NCT00887809|BG001|Baseline|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
11194118|NCT02150837|OG000|Outcome|5 & 2 & 2 Plan|"MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.~5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit."
11335716|NCT03555266|BG001|Baseline|Sham NSS-2 BRIDGE and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol~Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol."
10801831|NCT03409276|BG000|Baseline|Part A: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
10801832|NCT03409276|BG001|Baseline|Part A: Vaccine|Protein/ GLA-SE at Month (0, 2)
10801833|NCT03409276|BG002|Baseline|Part B: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
10966609|NCT00887809|BG002|Baseline|Total|Total of all reporting groups
10783578|NCT02489422|OG001|Outcome|Group II (Attention Control)|"Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.~Actigraphy Assessment: Ancillary studies"
10783579|NCT02489422|OG000|Outcome|Qualitative Interviews - Combined|Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments.
10783580|NCT02489422|EG000|Reported Event|Group I (Yoga Skills Training)|"Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.~Actigraphy Assessment: Ancillary studies"
10783581|NCT02489422|EG001|Reported Event|Group II (Attention Control)|"Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies~Daily Survey Administration: Ancillary studies~Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.~Actigraphy Assessment: Ancillary studies"
10783582|NCT02487251|BG000|Baseline|Experimental: Phase 1 Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783583|NCT02487251|BG001|Baseline|Experimental: Phase 1 Mealtime Support Activities|"Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783584|NCT02487251|BG002|Baseline|Experimental: Phase 2- Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783585|NCT02487251|BG003|Baseline|Experimental: Phase 2- Meal Delivery and Receipt of Cookware|"Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783586|NCT02487251|BG004|Baseline|Total|Total of all reporting groups
10783587|NCT02487251|FG000|Participant Flow|Experimental: Phase 1 Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783588|NCT02487251|FG001|Participant Flow|Experimental: Phase 1 Mealtime Support Activities|"Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783589|NCT02487251|FG002|Participant Flow|Experimental: Phase 2- Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783590|NCT02487251|FG003|Participant Flow|Experimental: Phase 2- Meal Delivery and Receipt of Cookware|"Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783591|NCT02487251|OG000|Outcome|Experimental: Phase 1 Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783592|NCT02487251|OG001|Outcome|Experimental: Phase 1 Mealtime Support Activities|"Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10801834|NCT03409276|BG003|Baseline|Part B: Vaccine 1|DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
10801835|NCT03409276|BG004|Baseline|Part B: Vaccine 2|DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
10783593|NCT02487251|OG002|Outcome|Experimental: Phase 2- Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783594|NCT02487251|OG003|Outcome|Experimental: Phase 2- Meal Delivery and Receipt of Cookware|"Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783595|NCT02487251|EG000|Reported Event|Experimental: Phase 1 Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783596|NCT02487251|EG001|Reported Event|Experimental: Phase 1 Mealtime Support Activities|"Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783597|NCT02487251|EG002|Reported Event|Experimental: Phase 2- Usual Exposure|"Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.~Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received"
10783598|NCT02487251|EG003|Reported Event|Experimental: Phase 2- Meal Delivery and Receipt of Cookware|"Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware~Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period."
10783599|NCT02476968|BG000|Baseline|Overall BRCAm|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.
10783600|NCT02476968|BG001|Baseline|HRRm^|Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm^).
10783601|NCT02476968|BG002|Baseline|Unassigned (Not BRCAm, Not HRRm^)|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm^ group and were enrolled in error.
11335717|NCT03555266|BG002|Baseline|Total|Total of all reporting groups
10783602|NCT02476968|BG003|Baseline|Total|Total of all reporting groups
10783603|NCT02476968|FG000|Participant Flow|Overall BRCAm|Patients received olaparib capsules orally 400 milligrams (mg) twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.
10783604|NCT02476968|FG001|Participant Flow|HRRm^|Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm^).
10783605|NCT02476968|FG002|Participant Flow|Unassigned (Not BRCAm, Not HRRm^)|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm^ group and were enrolled in error.
10783606|NCT02476968|OG000|Outcome|Overall BRCAm|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.
11338898|NCT03619837|EG000|Reported Event|Transplant Recipients|"Treatment Arm Single Arm: Sofosbuvir/Velpatasvir~Dosage: 400mg/100mg. Once daily for 12 weeks."
10783607|NCT02476968|OG001|Outcome|sBRCAm|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
10783608|NCT02476968|OG000|Outcome|BRCAm Overall|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not confirmed.
10783609|NCT02476968|EG000|Reported Event|gBRCAm Keep|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had gBRCAm disease (i.e. confirmed germline mutation).
10783610|NCT02476968|EG001|Reported Event|sBRCAm|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
10783611|NCT02476968|EG002|Reported Event|Overall BRCAm|Patients received olaparib capsules orally 400 milligrams (mg) twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.
10783612|NCT02476968|EG003|Reported Event|HRRm^|Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm^).
10783613|NCT02476968|EG004|Reported Event|Unassigned (Not BRCAm, Not HRRm^)|Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm^ group and were enrolled in error.
10783614|NCT02306122|BG000|Baseline|Default Patient|Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
10783615|NCT02306122|BG001|Baseline|Information Patient|Patient nonadherence information sent to physician
10783616|NCT02306122|BG002|Baseline|Control Patient|Control - no intervention
10783617|NCT02306122|BG003|Baseline|Choice Patient|Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
10783618|NCT02306122|BG004|Baseline|Information Doctor|Physician randomized to information only arm
10783619|NCT02306122|BG005|Baseline|Choice Doctor|Physician randomized to choice arm
10783620|NCT02306122|BG006|Baseline|Default Doctor|Physician randomized to default arm
10783621|NCT02306122|BG007|Baseline|Total|Total of all reporting groups
10783622|NCT02306122|FG000|Participant Flow|Default Patient Default Doctor|Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
10783623|NCT02306122|FG001|Participant Flow|Information Patient Default Doctor|Patient nonadherence information sent to physician
10783624|NCT02306122|FG002|Participant Flow|Control Patient Default Doctor|Control - no intervention
10783625|NCT02306122|FG003|Participant Flow|Choice Patient Choice Doctor|Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
10783626|NCT02306122|FG004|Participant Flow|Information Patient Choice Doctor|Patient nonadherence information sent to physician
10783627|NCT02306122|FG005|Participant Flow|Control Patient Choice Doctor|Control - no intervention
10783628|NCT02306122|FG006|Participant Flow|Information Patient Information Doctor|Patient nonadherence information sent to physician
10783629|NCT02306122|FG007|Participant Flow|Control Patient Information Doctor|Control - no intervention
10783630|NCT02306122|FG008|Participant Flow|Information Doctor|Physician randomized to Information Only arm
10783631|NCT02306122|FG009|Participant Flow|Default Doctor|Physician randomized to Default arm
10783632|NCT02306122|FG010|Participant Flow|Choice Doctor|Physician randomized to Choice arm
10783633|NCT02306122|OG000|Outcome|Default Patient|Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
10783634|NCT02306122|OG001|Outcome|Choice Patient|Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
10783635|NCT02306122|OG002|Outcome|Information Patient|Patient nonadherence information sent to physician
10783636|NCT02306122|OG003|Outcome|Control Patient|No information sent to physician, no opportunity for pharmacist intervention
10783637|NCT02306122|OG002|Outcome|Information Only Patient|Patient nonadherence information sent to physician
10783638|NCT02306122|EG000|Reported Event|Default Patient Default Doctor|"Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call~Pharmacist calls patient unless physician cancels call~Patient nonadherence information sent to physician"
10783639|NCT02306122|EG001|Reported Event|Information Patient Default Doctor|"Patient nonadherence information sent to physician~Patient nonadherence information sent to physician"
10783640|NCT02306122|EG002|Reported Event|Control Patient Default Doctor|Control - no intervention
10783641|NCT02306122|EG003|Reported Event|Choice Patient Choice Doctor|"Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call~Patient nonadherence information sent to physician~Pharmacist calls patient if physician requests call"
10783642|NCT02306122|EG004|Reported Event|Information Patient Choice Doctor|"Patient nonadherence information sent to physician~Patient nonadherence information sent to physician"
10783643|NCT02306122|EG005|Reported Event|Control Patient Choice Doctor|Control - no intervention
10783644|NCT02306122|EG006|Reported Event|Information Patient Information Doctor|"Patient nonadherence information sent to physician~Patient nonadherence information sent to physician"
10783645|NCT02306122|EG007|Reported Event|Control Patient Information Doctor|Control - no intervention
10783646|NCT02306122|EG008|Reported Event|Information Doctor|Doctor receives information and may be allowed certain actions
10783647|NCT02306122|EG009|Reported Event|Choice Doctor|Doctor receives information and may be allowed certain actions
10783648|NCT02306122|EG010|Reported Event|Default Doctor|Doctor receives information and may be allowed certain actions
10783649|NCT02304991|BG000|Baseline|Peanut (Liquid Peanut Extract) SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Liquid Peanut Extract: 5000mcg/ml peanut protein"
10783650|NCT02304991|BG001|Baseline|Placebo Glycerin SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color"
10783651|NCT02304991|BG002|Baseline|Total|Total of all reporting groups
10783652|NCT02304991|FG000|Participant Flow|Peanut (Liquid Peanut Extract) SLIT|"After the Double-Blind, Placebo-Controlled Food Challenge (DBPCFC), subjects randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Liquid Peanut Extract: 5000mcg/ml peanut protein"
10783653|NCT02304991|FG001|Participant Flow|Placebo Glycerin SLIT|"After the Double-Blind, Placebo-Controlled Food Challenge (DBPCFC), subjects randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color"
10783654|NCT02304991|OG000|Outcome|Peanut (Liquid Peanut Extract) SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Liquid Peanut Extract: 5000mcg/ml peanut protein"
10801836|NCT03409276|BG005|Baseline|Total|Total of all reporting groups
10783655|NCT02304991|OG001|Outcome|Placebo Glycerin SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color"
10783656|NCT02304991|EG000|Reported Event|Peanut (Liquid Peanut Extract) SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Liquid Peanut Extract: 5000mcg/ml peanut protein"
10783657|NCT02304991|EG001|Reported Event|Placebo Glycerin SLIT|"After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months.~Placebo Glycerin SLIT: pure glycerinated saline solution with caramel coloring to match color"
10783658|NCT02223520|BG000|Baseline|Mupirocin and Chlorhexidine|"Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.~Mupirocin and Chlorhexidine"
10783659|NCT02223520|BG001|Baseline|Placebo Ointment and Placebo Cloths|"Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.~Placebo ointment and placebo cloths"
10783660|NCT02223520|BG002|Baseline|Total|Total of all reporting groups
10783661|NCT02223520|FG000|Participant Flow|Mupirocin and Chlorhexidine|"Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.~Mupirocin and Chlorhexidine"
10783662|NCT02223520|FG001|Participant Flow|Placebo Ointment and Placebo Cloths|"Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.~Placebo ointment and placebo cloths"
10783663|NCT02223520|OG000|Outcome|Mupirocin and Chlorhexidine|"Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.~Mupirocin and Chlorhexidine"
10783664|NCT02223520|OG001|Outcome|Placebo Ointment and Placebo Cloths|"Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.~Placebo ointment and placebo cloths"
10783665|NCT02223520|EG000|Reported Event|Mupirocin and Chlorhexidine|"Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.~Mupirocin and Chlorhexidine"
10783666|NCT02223520|EG001|Reported Event|Placebo Ointment and Placebo Cloths|"Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.~Placebo ointment and placebo cloths"
10783667|NCT02147184|BG000|Baseline|SSRI Group|Participants within one month of starting an SSRI
10783668|NCT02147184|BG001|Baseline|Unmedicated Group|No treatment with SSRIs
10783669|NCT02147184|BG002|Baseline|Total|Total of all reporting groups
10783670|NCT02147184|FG000|Participant Flow|SSRI Group|Participants within one month of starting an SSRI
10783671|NCT02147184|FG001|Participant Flow|Unmedicated Group|No treatment with SSRIs
10783672|NCT02147184|OG000|Outcome|SSRI Group|Participants within one month of starting an SSRI
10783673|NCT02147184|OG001|Outcome|Unmedicated Group|No treatment with SSRIs
10783674|NCT02147184|EG000|Reported Event|SSRI Group|Participants within one month of starting an SSRI
10783675|NCT02147184|EG001|Reported Event|Unmedicated Group|No treatment with SSRIs
10783676|NCT02122198|BG000|Baseline|Placebo|"Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)~Placebo: placebo"
10783677|NCT02122198|BG001|Baseline|GnRH Agonist|"Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30."
10783678|NCT02122198|BG002|Baseline|Total|Total of all reporting groups
10783679|NCT02122198|FG000|Participant Flow|Placebo|"Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)~Placebo: placebo"
10783680|NCT02122198|FG001|Participant Flow|GnRH Agonist|"Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30."
10783681|NCT02122198|OG000|Outcome|Placebo|"Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)~Placebo: placebo"
10783682|NCT02122198|OG001|Outcome|GnRH Agonist|"Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30."
10801837|NCT03409276|FG000|Participant Flow|Part A: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
10801838|NCT03409276|FG001|Participant Flow|Part A: Vaccine|Protein/ GLA-SE at Month (0, 2)
10783683|NCT02122198|OG000|Outcome|GnRH Agonist|"Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30."
10783684|NCT02122198|EG000|Reported Event|Placebo|"Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)~Placebo: placebo"
10964631|NCT00878553|FG000|Participant Flow|Baseline: All Randomized Patients|"The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.~This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two double-dummy tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design."
10964632|NCT00878553|FG001|Participant Flow|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
10964633|NCT00878553|FG002|Participant Flow|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
10964634|NCT00878553|FG003|Participant Flow|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11335718|NCT03555266|FG000|Participant Flow|NSS-2 Bridge and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol."
10783685|NCT02122198|EG001|Reported Event|GnRH Agonist|"Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30."
10783686|NCT02055053|BG000|Baseline|Anesthetic Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.~0.5% Bupivicaine: Local anesthetic"
10783687|NCT02055053|BG001|Baseline|Saline Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.~0.5% Bupivicaine: Local anesthetic"
10783688|NCT02055053|BG002|Baseline|Total|Total of all reporting groups
10783689|NCT02055053|FG000|Participant Flow|Anesthetic Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.~0.5% Bupivicaine: Local anesthetic"
10783690|NCT02055053|FG001|Participant Flow|Saline Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.~0.5% Bupivicaine: Local anesthetic"
10783691|NCT02055053|OG000|Outcome|Anesthetic Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.~0.5% Bupivicaine: Local anesthetic"
10783692|NCT02055053|OG001|Outcome|Saline Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.~0.5% Bupivicaine: Local anesthetic"
10801839|NCT03409276|FG002|Participant Flow|Part B: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
10964635|NCT00878553|FG004|Participant Flow|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
10966610|NCT00887809|FG000|Participant Flow|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
10966611|NCT00887809|FG001|Participant Flow|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
10783693|NCT02055053|EG000|Reported Event|Anesthetic Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.~0.5% Bupivicaine: Local anesthetic"
10783694|NCT02055053|EG001|Reported Event|Saline Intervention|"After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.~0.5% Bupivicaine: Local anesthetic"
10783695|NCT02000219|BG000|Baseline|Oxabact OC5 Capsule|"This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment.~In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.~Oxalobacter formigenes: The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner."
10783696|NCT02000219|FG000|Participant Flow|Oxabact OC5 Capsule|"This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment.~In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.~Oxalobacter formigenes: The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner."
10783697|NCT02000219|OG000|Outcome|Oxabact OC5 Capsule|"This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment.~In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.~Oxalobacter formigenes: The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner."
10783698|NCT02000219|EG000|Reported Event|Oxabact OC5 Capsule|"This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment.~In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.~Oxalobacter formigenes: The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner."
10783699|NCT01978938|BG000|Baseline|Eravacycline|Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.
10783700|NCT01978938|BG001|Baseline|Levofloxacin|Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
10783701|NCT01978938|BG002|Baseline|Total|Total of all reporting groups
10783702|NCT01978938|FG000|Participant Flow|Eravacycline|Eravacycline was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram (mg/kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-oral (PO) transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day (BID) for a total therapy of 7 dosing cycles.
10783703|NCT01978938|FG001|Participant Flow|Levofloxacin|Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day (QD) for a total therapy of 7 dosing cycles.
11338899|NCT03619889|BG000|Baseline|Control Group|"A simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group.~Sham: A simulated pressure release technique is applied around masticatory and neck muscles."
10783704|NCT01978938|OG000|Outcome|Eravacycline|Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.
10783705|NCT01978938|OG001|Outcome|Levofloxacin|Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
10783706|NCT01978938|EG000|Reported Event|Eravacycline|Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.
10783707|NCT01978938|EG001|Reported Event|Levofloxacin|Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO QD for a total therapy of 7 dosing cycles.
10783708|NCT01854385|BG000|Baseline|Sumatriptan|"Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.~Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI."
10801840|NCT03409276|FG003|Participant Flow|Part B: Vaccine 1|DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
10801841|NCT03409276|FG004|Participant Flow|Part B: Vaccine 2|DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
10801842|NCT03409276|OG000|Outcome|Part A: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
10783709|NCT01854385|FG000|Participant Flow|Sumatriptan|"Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.~Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI."
10783710|NCT01854385|OG000|Outcome|Sumatriptan|"Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.~Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI."
10783711|NCT01854385|EG000|Reported Event|Sumatriptan|"Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.~Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI."
10783712|NCT01844856|BG000|Baseline|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
10783713|NCT01844856|BG001|Baseline|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
10783714|NCT01844856|BG002|Baseline|Total|Total of all reporting groups
10783715|NCT01844856|FG000|Participant Flow|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
10783716|NCT01844856|FG001|Participant Flow|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
10783717|NCT01844856|OG000|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
10783718|NCT01844856|OG001|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
10783719|NCT01844856|EG000|Reported Event|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
10783720|NCT01844856|EG001|Reported Event|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
10783721|NCT01788306|BG000|Baseline|Intervention (OOPEN+BBCC)|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10783722|NCT01788306|BG001|Baseline|Control|Standard of care, referral to local available resources.
10783723|NCT01788306|BG002|Baseline|Total|Total of all reporting groups
10783724|NCT01788306|FG000|Participant Flow|Intervention (OOPEN+BBCC)|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10783725|NCT01788306|FG001|Participant Flow|Control|Standard of care, referral to local available resources.
10783726|NCT01788306|OG000|Outcome|Intervention (OOPEN+BBCC)|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10783727|NCT01788306|OG001|Outcome|Control|Standard of care, referral to local available resources.
10783728|NCT01788306|OG000|Outcome|Intervention (OOPEN+BBCC) - Permanent or Stable Housing|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10783729|NCT01788306|OG001|Outcome|Intervention (OOPEN+BBCC) - Temporary or Unstable Housing or Unhoused|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10966612|NCT00887809|OG000|Outcome|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
10783730|NCT01788306|OG002|Outcome|Control - Permanent or Stable Housing|Standard of care, referral to local available resources.
10783731|NCT01788306|OG003|Outcome|Control - Temporary or Unstable Housing or Unhoused.|Standard of care, referral to local available resources.
10783732|NCT01788306|OG002|Outcome|Control - Permanent or Stable Housing.|Standard of care, referral to local available resources.
10783733|NCT01788306|OG003|Outcome|Control - Temporary or Unstable Housing or Unhoused|Standard of care, referral to local available resources.
10783734|NCT01788306|EG000|Reported Event|Intervention (OOPEN+BBCC)|"Study intervention, overdose prevention, education, intervention, brief behavioral change counseling, take-home naloxone, referral to local available resources.~OOPEN+BBCC: Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose."
10783735|NCT01788306|EG001|Reported Event|Control|Standard of care, referral to local available resources.
10966613|NCT00887809|OG001|Outcome|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
10783736|NCT01744041|BG000|Baseline|Dyadic Interpersonal Psychotherapy|"Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum~Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship."
10783737|NCT01744041|BG001|Baseline|Enhanced Treatment as Usual|"Personalized referral to community resources for depression treatment~Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone."
10783738|NCT01744041|BG002|Baseline|Total|Total of all reporting groups
10783739|NCT01744041|FG000|Participant Flow|Dyadic Interpersonal Psychotherapy|"Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum~Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship."
10783740|NCT01744041|FG001|Participant Flow|Enhanced Treatment as Usual|"Personalized referral to community resources for depression treatment~Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone."
10783741|NCT01744041|OG000|Outcome|Dyadic Interpersonal Psychotherapy|"Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum~Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship."
10783742|NCT01744041|OG001|Outcome|Enhanced Treatment as Usual|"Personalized referral to community resources for depression treatment~Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone."
10783743|NCT01744041|EG000|Reported Event|Dyadic Interpersonal Psychotherapy|"Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum~Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship."
10783744|NCT01744041|EG001|Reported Event|Enhanced Treatment as Usual|"Personalized referral to community resources for depression treatment~Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone."
10783745|NCT01733147|BG000|Baseline|Placebo|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.~Placebo: 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal."
10783746|NCT01733147|BG001|Baseline|Omega-3 Polyunsaturated Fatty Acids|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.~Omega-3 polyunsaturated fatty acids: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA."
10783747|NCT01733147|BG002|Baseline|Total|Total of all reporting groups
10783748|NCT01733147|FG000|Participant Flow|Placebo|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.~Placebo: 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal."
10783749|NCT01733147|FG001|Participant Flow|Omega-3 Polyunsaturated Fatty Acids|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.~Omega-3 polyunsaturated fatty acids: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA."
10783750|NCT01733147|OG000|Outcome|Placebo|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.~Placebo: 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal."
10783751|NCT01733147|OG001|Outcome|Omega-3 Polyunsaturated Fatty Acids|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.~Omega-3 polyunsaturated fatty acids: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA."
10783752|NCT01733147|EG000|Reported Event|Placebo|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.~Placebo: 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal."
10801843|NCT03409276|OG001|Outcome|Part A: Vaccine|Protein/ GLA-SE at Month (0, 2)
11243310|NCT02502149|FG001|Participant Flow|15K rFVIIIFc (1000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for pharmacokinetic assessment 2 (PK2). Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with15K rFVIIIFc, participants will be re-evaluated at Pharmacokinetic assessment 3 (PK3) at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11380683|NCT02348216|OG001|Outcome|Phase 2 (Pivotal Study): Cohort 2|Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380684|NCT02348216|OG000|Outcome|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV BID) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
11380685|NCT02348216|OG000|Outcome|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380686|NCT02348216|OG000|Outcome|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380687|NCT02348216|OG000|Outcome|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
10783753|NCT01733147|EG001|Reported Event|Omega-3 Polyunsaturated Fatty Acids|"Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.~Omega-3 polyunsaturated fatty acids: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA."
10801844|NCT03409276|OG002|Outcome|Part B: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
10801845|NCT03409276|OG003|Outcome|Part B: Vaccine 1|DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
11380688|NCT02348216|OG002|Outcome|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV BID) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
11380689|NCT02348216|OG003|Outcome|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380690|NCT02348216|OG004|Outcome|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380691|NCT02348216|OG005|Outcome|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
10783754|NCT01712789|BG000|Baseline|Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)|Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
10801846|NCT03409276|OG004|Outcome|Part B: Vaccine 2|DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
10801847|NCT03409276|OG000|Outcome|Part A: Vaccine|Protein/ GLA-SE at Month (0, 2)
10783755|NCT01712789|FG000|Participant Flow|Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)|Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
11380692|NCT02348216|OG001|Outcome|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380693|NCT02348216|OG002|Outcome|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380694|NCT02348216|OG003|Outcome|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380695|NCT02348216|OG001|Outcome|Phase 2 (Pivotal Study): Cohort 1|Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380696|NCT02348216|OG002|Outcome|Phase 2 (Pivotal Study): Cohort 2|Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380697|NCT02348216|OG003|Outcome|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV BID) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
10801848|NCT03409276|OG001|Outcome|Part B: Vaccine 1|DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
10801849|NCT03409276|OG002|Outcome|Part B: Vaccine 2|DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
10801850|NCT03409276|OG000|Outcome|Part B: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
10801851|NCT03409276|EG000|Reported Event|Part A: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
11194119|NCT02150837|OG001|Outcome|4 & 2 & 1 Plan|"MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.~4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit."
11194120|NCT02150837|EG000|Reported Event|5 & 2 & 2 Plan|"MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.~5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit."
11194121|NCT02150837|EG001|Reported Event|4 & 2 & 1 Plan|"MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.~4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit."
11194122|NCT02150954|BG000|Baseline|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
11194123|NCT02150954|BG001|Baseline|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
11194124|NCT02150954|BG002|Baseline|Total|Total of all reporting groups
11194125|NCT02150954|FG000|Participant Flow|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
11194126|NCT02150954|FG001|Participant Flow|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
11194127|NCT02150954|OG000|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
11194128|NCT02150954|OG001|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
10801852|NCT03409276|EG001|Reported Event|Part A: Vaccine|Protein/ GLA-SE at Month (0, 2)
11194129|NCT02150954|EG000|Reported Event|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
11194130|NCT02150954|EG001|Reported Event|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
11194131|NCT02151058|BG000|Baseline|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
11194132|NCT02151058|BG001|Baseline|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
11194133|NCT02151058|BG002|Baseline|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
11194134|NCT02151058|BG003|Baseline|Total|Total of all reporting groups
11194135|NCT02151058|FG000|Participant Flow|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
11194136|NCT02151058|FG001|Participant Flow|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
11194137|NCT02151058|FG002|Participant Flow|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
11194138|NCT02151058|OG000|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
11194139|NCT02151058|OG001|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
11194140|NCT02151058|OG002|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
10801853|NCT03409276|EG002|Reported Event|Part B: Placebo|Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
10783756|NCT01712789|OG000|Outcome|Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)|Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
10783757|NCT01712789|EG000|Reported Event|Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)|Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
10783758|NCT01651403|BG000|Baseline|Tenofovir Disoproxil Fumarate|"Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10783759|NCT01651403|BG001|Baseline|Placebo|"Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10783760|NCT01651403|BG002|Baseline|Total|Total of all reporting groups
10783761|NCT01651403|FG000|Participant Flow|Tenofovir Disoproxil Fumarate|"Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10783762|NCT01651403|FG001|Participant Flow|Placebo|"Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10783763|NCT01651403|OG000|Outcome|TDF (Blinded Randomized Phase)|Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
10783764|NCT01651403|OG001|Outcome|Placebo (Blinded Randomized Phase)|Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
10783765|NCT01651403|OG000|Outcome|TDF to TDF|"Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3)."
10783766|NCT01651403|OG001|Outcome|Placebo to TDF|"Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3)."
10783767|NCT01651403|OG000|Outcome|TDF to TDF|"Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)~Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3)."
10783768|NCT01651403|EG000|Reported Event|TDF (Blinded Randomized Phase)|Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
10783769|NCT01651403|EG001|Reported Event|Placebo (Blinded Randomized Phase)|Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
10783770|NCT01651403|EG002|Reported Event|TDF to TDF (Open-Label Phase)|"Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10783771|NCT01651403|EG003|Reported Event|Placebo to TDF (Open-Label Phase)|"Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).~Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight."
10801854|NCT03409276|EG003|Reported Event|Part B: Vaccine 1|DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
11194141|NCT02151058|EG000|Reported Event|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
11194142|NCT02151058|EG001|Reported Event|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
11380698|NCT02348216|OG004|Outcome|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380699|NCT02348216|OG005|Outcome|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380700|NCT02348216|OG006|Outcome|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
10783772|NCT01543633|BG000|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.~Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press)."
10801855|NCT03409276|EG004|Reported Event|Part B: Vaccine 2|DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
10966614|NCT00887809|EG000|Reported Event|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
11194143|NCT02151058|EG002|Reported Event|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
11194144|NCT02151110|BG000|Baseline|Placebo|Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
11194145|NCT02151110|BG001|Baseline|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
11194146|NCT02151110|BG002|Baseline|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
11194147|NCT02151110|BG003|Baseline|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
11194148|NCT02151110|BG004|Baseline|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
11194149|NCT02151110|BG005|Baseline|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
11194150|NCT02151110|BG006|Baseline|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
11194151|NCT02151110|BG007|Baseline|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
11194152|NCT02151110|BG008|Baseline|TOTAL|Total of all reporting groups
10783773|NCT01543633|FG000|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.~Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press)."
10783774|NCT01543633|OG000|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.~Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press)."
10783775|NCT01543633|EG000|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.~Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press)."
10783776|NCT01542736|BG000|Baseline|Reduced Radiation With Concurrent Chemotherapy|"Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration~Carboplatin: Administered concurrently with craniospinal radiation.~Vincristine: Administered concurrently with craniospinal radiation.~24 Gy: Craniospinal radiation."
10783777|NCT01542736|FG000|Participant Flow|Reduced Radiation With Concurrent Chemotherapy|"Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration~Carboplatin: Administered concurrently with craniospinal radiation.~Vincristine: Administered concurrently with craniospinal radiation.~24 Gy: Craniospinal radiation."
10783778|NCT01542736|OG000|Outcome|Reduced Radiation With Concurrent Chemotherapy|"Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration~Carboplatin: Administered concurrently with craniospinal radiation.~Vincristine: Administered concurrently with craniospinal radiation.~24 Gy: Craniospinal radiation."
10783779|NCT01542736|EG000|Reported Event|Reduced Radiation With Concurrent Chemotherapy|"Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration~Carboplatin: Administered concurrently with craniospinal radiation.~Vincristine: Administered concurrently with craniospinal radiation.~24 Gy: Craniospinal radiation."
10783780|NCT01535807|BG000|Baseline|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783781|NCT01535807|BG001|Baseline|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783782|NCT01535807|BG002|Baseline|Total|Total of all reporting groups
10783783|NCT01535807|FG000|Participant Flow|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783784|NCT01535807|FG001|Participant Flow|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783785|NCT01535807|OG000|Outcome|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783786|NCT01535807|OG001|Outcome|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783787|NCT01535807|EG000|Reported Event|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783788|NCT01535807|EG001|Reported Event|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
10783789|NCT01147666|BG000|Baseline|Cohort A-1 (Roxadustat 1.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783790|NCT01147666|BG001|Baseline|Cohort A-2 (Roxadustat 1.5 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783791|NCT01147666|BG002|Baseline|Cohort A-3 (Roxadustat 2.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783792|NCT01147666|BG003|Baseline|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783793|NCT01147666|BG004|Baseline|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783794|NCT01147666|BG005|Baseline|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783795|NCT01147666|BG006|Baseline|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783796|NCT01147666|BG007|Baseline|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783797|NCT01147666|BG008|Baseline|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783798|NCT01147666|BG009|Baseline|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783799|NCT01147666|BG010|Baseline|Cohorts A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783800|NCT01147666|BG011|Baseline|Cohort B-1 (Roxadustat 1.5 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783801|NCT01147666|BG012|Baseline|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783802|NCT01147666|BG013|Baseline|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783803|NCT01147666|BG014|Baseline|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
10783804|NCT01147666|BG015|Baseline|Total|Total of all reporting groups
10783805|NCT01147666|FG000|Participant Flow|Cohort A-1 (Roxadustat 1.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (11.0-13.0 grams [g]/deciliter [dL]) was based upon regular monitoring of Hb.
10783806|NCT01147666|FG001|Participant Flow|Cohort A-2 (Roxadustat 1.5 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10966615|NCT00887809|EG001|Reported Event|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
11194153|NCT02151110|FG000|Participant Flow|Placebo|Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
11194154|NCT02151110|FG001|Participant Flow|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
11194155|NCT02151110|FG002|Participant Flow|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
11194156|NCT02151110|FG003|Participant Flow|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
11194157|NCT02151110|FG004|Participant Flow|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
10783807|NCT01147666|FG002|Participant Flow|Cohort A-3 (Roxadustat 2.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783808|NCT01147666|FG003|Participant Flow|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783809|NCT01147666|FG004|Participant Flow|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783810|NCT01147666|FG005|Participant Flow|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783811|NCT01147666|FG006|Participant Flow|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783812|NCT01147666|FG007|Participant Flow|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783813|NCT01147666|FG008|Participant Flow|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783814|NCT01147666|FG009|Participant Flow|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783815|NCT01147666|FG010|Participant Flow|Cohorts A (Epoetin Alfa)|Normoresponsive participants received intravenous (IV) epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783816|NCT01147666|FG011|Participant Flow|Cohort B-1 (Roxadustat 1.5 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11338900|NCT03619889|BG001|Baseline|Intervention Group|"The release pressure technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis.~Manual pressure release technique on trigger points.: A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale)."
10783817|NCT01147666|FG012|Participant Flow|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783818|NCT01147666|FG013|Participant Flow|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783819|NCT01147666|FG014|Participant Flow|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
10783820|NCT01147666|OG000|Outcome|Cohort A-1 (Roxadustat 1.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783821|NCT01147666|OG001|Outcome|Cohort A-2 (Roxadustat 1.5 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11194158|NCT02151110|FG005|Participant Flow|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
11380701|NCT02348216|OG001|Outcome|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380702|NCT02348216|OG002|Outcome|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380703|NCT02348216|EG000|Reported Event|Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy|Participants with DLBCL, primary PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380704|NCT02348216|EG001|Reported Event|Phase 2 (Pivotal Study): Cohort 1|Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380705|NCT02348216|EG002|Reported Event|Phase 2 (Pivotal Study): Cohort 2|Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered.
11380706|NCT02348216|EG003|Reported Event|Phase 2 (Safety Management Study): Cohort 3|Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received a prophylactic regimen of tocilizumab and levetiracetam. The prophylactic regimen comprised levetiracetam (750 mg orally or IV BID) starting on Day 0 and tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg]) on Day 2.
11194159|NCT02151110|FG006|Participant Flow|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
11194160|NCT02151110|FG007|Participant Flow|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
11194161|NCT02151110|OG000|Outcome|Placebo|Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
11338901|NCT03619889|BG002|Baseline|Total|Total of all reporting groups
11338902|NCT03619889|FG000|Participant Flow|Sham Simulation GROUP|"A simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group.~Sham: A simulated pressure release technique is applied around masticatory and neck muscles."
11338903|NCT03619889|FG001|Participant Flow|Manual Pressure Release Technique GROUP|"The Pressure Release Technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis.~Manual pressure release technique on trigger points.: A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale)."
11338904|NCT03619889|OG000|Outcome|Sham Simulation GROUP|"A simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group.~Sham: A simulated pressure release technique is applied around masticatory and neck muscles."
11338905|NCT03619889|OG001|Outcome|Pressure Release Technique GROUP|"The release pressure technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis.~Manual pressure release technique on trigger points.: A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale)."
11338906|NCT03619889|EG000|Reported Event|Sham Simulation GROUP|simulation of the pressure release technique
11338907|NCT03619889|EG001|Reported Event|Pressure Pain Technique GROUP|pressure release technique consists in aply pressure on muscular trigger points during 90 sec until the tissue barrier releases
11338908|NCT03620162|BG000|Baseline|Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™|Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338909|NCT03620162|BG001|Baseline|Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338910|NCT03620162|BG002|Baseline|Group 3: Prevnar 13™-Prevnar 13™-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338911|NCT03620162|BG003|Baseline|Group 4: Prevnar 13™-V114-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338912|NCT03620162|BG004|Baseline|Group 5: V114-V114-V114-V114|Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338913|NCT03620162|BG005|Baseline|Total|Total of all reporting groups
11338914|NCT03620162|FG000|Participant Flow|Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™|Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338915|NCT03620162|FG001|Participant Flow|Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338916|NCT03620162|FG002|Participant Flow|Group 3: Prevnar 13™-Prevnar 13™-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338917|NCT03620162|FG003|Participant Flow|Group 4: Prevnar 13™-V114-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338918|NCT03620162|FG004|Participant Flow|Group 5: V114-V114-V114-V114|Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
10783822|NCT01147666|OG002|Outcome|Cohort A-3 (Roxadustat 2.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783823|NCT01147666|OG003|Outcome|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783824|NCT01147666|OG004|Outcome|Cohort A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783825|NCT01147666|OG000|Outcome|Cohort B-1 (Roxadustat 1.5 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783826|NCT01147666|OG001|Outcome|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783827|NCT01147666|OG002|Outcome|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783828|NCT01147666|OG003|Outcome|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
10783829|NCT01147666|OG000|Outcome|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783830|NCT01147666|OG001|Outcome|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783831|NCT01147666|OG002|Outcome|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783832|NCT01147666|OG003|Outcome|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783833|NCT01147666|OG004|Outcome|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783834|NCT01147666|OG005|Outcome|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783835|NCT01147666|OG006|Outcome|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783836|NCT01147666|OG007|Outcome|Cohorts A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783837|NCT01147666|OG008|Outcome|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11380707|NCT02348216|EG004|Reported Event|Phase 2 (Safety Management Study): Cohort 4|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received earlier interventions with corticosteroids (dexamethasone, methylprednisolone) and/or tocilizumab (8 mg/kg IV over 1 hour [not to exceed 800 mg] at lower grades of toxicity), in addition to prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380708|NCT02348216|EG005|Reported Event|Phase 2 (Safety Management Study): Cohort 5|Participants with relapsed/refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR T cells IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing >100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Debulking therapy was administered to reduce a participant's disease prior to conditioning chemotherapy. Participants received a prophylactic regimen of levetiracetam (750 mg orally or IV BID) starting on Day 0. Debulking therapy regimen was chosen at investigator's discretion and could include: R-CHOP (rituximab 375 mg/m^2 Day 1, doxorubicin 50 mg/m^2 Day 1, prednisone 100 mg Days 1 to 5, cyclophosphamide 750 mg/m^2 Day 1, vincristine 1.4 mg/m^2 Day 1); R-ICE (rituximab 375 mg/m^2 Day 1, ifosfamide 5 g/m^2 24h-CI Day 2, carboplatin AUC5 Day 2 maximum dose 800 mg, etoposide 100 mg/m^2/day Days 1 to 3); R-GEMOX (rituximab 375 mg/m^2 Day 1, gemcitabine 1000 mg/m^2 Day 2, oxaliplatin 100 mg/m^2 Day 2); R-GDP (rituximab 375 mg/m^2 Day 1 or 8, gemcitabine 1 g/m^2 on Day 1 and 8, dexamethasone 40 mg on Days 1 to Day 4, cisplatin 75 mg/m^2 on Day 1 [or carboplatin AUC5 on Day 1]); or radiotherapy per local standard up to 20 to 30 Gy.
11380709|NCT02348216|EG006|Reported Event|Phase 2 (Safety Management Study): Cohort 6|Participants with relapsed or refractory DLBCL, PMBCL, TFL, or HGBCL after 2 systemic lines of therapy received conditioning chemotherapy (fludarabine 30 mg/m^2 IV over 30 minutes and cyclophosphamide 500 mg/m^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of BW (a minimum infusion of at least 1 × 10^6 cell/kg of BW) on Day 0. For participants weighing greater than 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells was administered. Bridging therapy was administered to control a participant's disease prior to conditioning chemotherapy. Bridging therapy regimen was chosen at the discretion of the investigator and could include: dexamethasone at a dose of 20 mg to 40 mg or equivalent, either PO or IV daily for 1 to 4 days; or 1 g/m^2 of HDMP for 3 days in combination with rituximab at 375 mg/m^2 weekly for 3 weeks; or combination chemotherapy bendamustine (90 mg/m^2, Days 1 and 2 and rituximab (375 mg/m^2, Day 1). Participants also received interventions with corticosteroids (dexamethasone) and/or tocilizumab at lower grades of toxicity, prophylactic corticosteroids (given prior to axicabtagene ciloleucel infusion on Day 0, Day 1 and Day 2), and prophylactic levetiracetam (750 mg orally or IV BID starting on Day 0).
11380710|NCT02348216|EG007|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 1|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.
11380711|NCT02348216|EG008|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
11380712|NCT02348216|EG009|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
11380713|NCT02348216|EG010|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
11380714|NCT02348216|EG011|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
11380715|NCT02348216|EG012|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
11380716|NCT02348216|EG013|Reported Event|Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6|Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
10783838|NCT01147666|OG009|Outcome|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
11194162|NCT02151110|OG001|Outcome|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
10783839|NCT01147666|OG010|Outcome|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
10783840|NCT01147666|OG004|Outcome|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783841|NCT01147666|OG005|Outcome|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783842|NCT01147666|OG006|Outcome|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783843|NCT01147666|OG007|Outcome|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783844|NCT01147666|OG008|Outcome|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783845|NCT01147666|OG009|Outcome|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783846|NCT01147666|OG010|Outcome|Cohorts A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783847|NCT01147666|OG011|Outcome|Cohort B-1 (Roxadustat 1.5 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783848|NCT01147666|OG012|Outcome|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783849|NCT01147666|OG013|Outcome|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783850|NCT01147666|OG014|Outcome|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
10783851|NCT01147666|OG004|Outcome|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783852|NCT01147666|OG005|Outcome|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783853|NCT01147666|OG006|Outcome|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11194163|NCT02151110|OG002|Outcome|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
11194164|NCT02151110|OG003|Outcome|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
11194165|NCT02151110|OG004|Outcome|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
11194166|NCT02151110|OG005|Outcome|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
11194167|NCT02151110|OG006|Outcome|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
11194168|NCT02151110|OG007|Outcome|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
11194169|NCT02151110|OG000|Outcome|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
10783854|NCT01147666|OG007|Outcome|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783855|NCT01147666|OG008|Outcome|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783856|NCT01147666|OG009|Outcome|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783857|NCT01147666|OG010|Outcome|Cohort A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783858|NCT01147666|OG002|Outcome|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783859|NCT01147666|OG003|Outcome|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783860|NCT01147666|OG004|Outcome|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783861|NCT01147666|OG006|Outcome|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring o
10783862|NCT01147666|OG003|Outcome|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783863|NCT01147666|OG012|Outcome|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783864|NCT01147666|OG014|Outcome|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
10783865|NCT01147666|EG000|Reported Event|Cohort A-1 (Roxadustat 1.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783866|NCT01147666|EG001|Reported Event|Cohort A-2 (Roxadustat 1.5 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783867|NCT01147666|EG002|Reported Event|Cohort A-3 (Roxadustat 2.0 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11194170|NCT02151110|OG001|Outcome|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
11194171|NCT02151110|OG002|Outcome|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
11194172|NCT02151110|OG003|Outcome|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
11194173|NCT02151110|OG004|Outcome|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
11194174|NCT02151110|OG005|Outcome|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
10783868|NCT01147666|EG003|Reported Event|Cohort A-4 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783869|NCT01147666|EG004|Reported Event|Cohort A-5 (Roxadustat 1.8 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11194175|NCT02151110|OG006|Outcome|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
11194176|NCT02151110|EG000|Reported Event|Placebo|Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
11194177|NCT02151110|EG001|Reported Event|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
11194178|NCT02151110|EG002|Reported Event|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
11194179|NCT02151110|EG003|Reported Event|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
11194180|NCT02151110|EG004|Reported Event|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
11194181|NCT02151110|EG005|Reported Event|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
11194182|NCT02151110|EG006|Reported Event|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
11194183|NCT02151110|EG007|Reported Event|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
11194184|NCT02151149|BG000|Baseline|Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194185|NCT02151149|BG001|Baseline|Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)|Participant ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8 and 15 followed by a one week break in each 28-day treatment cycle and carboplatin area under the curve (AUC) = 6 mg*min/mL IV on Day 1 of each treatment cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194186|NCT02151149|BG002|Baseline|Total|Total of all reporting groups
11194187|NCT02151149|FG000|Participant Flow|Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194188|NCT02151149|FG001|Participant Flow|Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10783870|NCT01147666|EG005|Reported Event|Cohort A-6 (Roxadustat 1.3 mg/kg TIW)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
11194189|NCT02151149|OG000|Outcome|Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194190|NCT02151149|OG001|Outcome|Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194191|NCT02151149|EG000|Reported Event|Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194192|NCT02151149|EG001|Reported Event|Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)|Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11194193|NCT02151253|BG000|Baseline|All Randomized Participants|
11194194|NCT02151253|FG000|Participant Flow|Armodafinil First, Then Placebo|"During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
11194195|NCT02151253|FG001|Participant Flow|Placebo First, Then Armodafinil|"During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
11194196|NCT02151253|OG000|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
11194197|NCT02151253|OG001|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
11380717|NCT02275559|BG000|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses."
11380718|NCT02275559|BG001|Baseline|Healthy Living Course (HLC)|"The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support"
11380719|NCT02275559|BG002|Baseline|Total|Total of all reporting groups
11380720|NCT02275559|FG000|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses."
11380721|NCT02275559|FG001|Participant Flow|Healthy Living Course (HLC)|"The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support"
11380722|NCT02275559|OG000|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses."
11380723|NCT02275559|OG001|Outcome|Healthy Living Course (HLC)|"The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support"
11380724|NCT02275559|OG000|Outcome|Mindfulness Based Stress Reduction Compared to Healthy Living Course|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~The two arms are combined for this analysis"
11380725|NCT02275559|OG000|Outcome|Mindfulness Based Stress Reduction Compared to Healthy Living Course|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~The two arms are combined for this analysis"
10783871|NCT01147666|EG006|Reported Event|Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783872|NCT01147666|EG007|Reported Event|Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783873|NCT01147666|EG008|Reported Event|Cohort A-9 (Roxadustat 2.0 mg/kg)|Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783874|NCT01147666|EG009|Reported Event|Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)|Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783875|NCT01147666|EG010|Reported Event|Cohorts A (Epoetin Alfa)|Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783876|NCT01147666|EG011|Reported Event|Cohort B-1 (Roxadustat 1.5 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783877|NCT01147666|EG012|Reported Event|Cohort B-2 (Roxadustat 2.0 mg/kg TIW)|Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
10783878|NCT01147666|EG013|Reported Event|Cohort B (Epoetin Alfa)|Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
10783879|NCT01147666|EG014|Reported Event|Cohort B (Placebo)|Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
10783880|NCT00982111|BG000|Baseline|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
10783881|NCT00982111|BG001|Baseline|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
10783882|NCT00982111|BG002|Baseline|Total|Total of all reporting groups
10783883|NCT00982111|FG000|Participant Flow|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.~Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
10783884|NCT00982111|FG001|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
10783885|NCT00982111|OG000|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
10783886|NCT00982111|OG001|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
10783887|NCT00982111|OG000|Outcome|Necitumumab + Pemextrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
10783888|NCT00982111|EG000|Reported Event|Necitumumab+Pemetrexed+Cisplatin|Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
10783889|NCT00982111|EG001|Reported Event|Pemetrexed+Cisplatin|Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
10783890|NCT00193219|BG000|Baseline|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
10783891|NCT00193219|FG000|Participant Flow|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
10783892|NCT00193219|OG000|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
10783893|NCT00193219|EG000|Reported Event|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
10783894|NCT00193219|EG001|Reported Event|Bevacizumab/FOLFOX|Bevacizumab 5 mg/kg IV; Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient); Leucovorin 350 mg IV; Oxaliplatin 85 mg/m2 IV
10783895|NCT00116142|BG000|Baseline|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen Suppression Therapy + Radiation therapy~Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression"
10783896|NCT00116142|BG001|Baseline|Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy|"Docetaxel + Androgen Suppression Therapy + Radiation Therapy~Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression"
10783897|NCT00116142|BG002|Baseline|Total|Total of all reporting groups
10783898|NCT00116142|FG000|Participant Flow|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen Suppression Therapy + Radiation therapy~Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression"
10783899|NCT00116142|FG001|Participant Flow|Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy|"Docetaxel + Androgen Suppression Therapy + Radiation Therapy~Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression"
10783900|NCT00116142|OG000|Outcome|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen Suppression Therapy + Radiation Therapy~Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression"
10783901|NCT00116142|OG001|Outcome|Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy|"Docetaxel + Androgen Suppression Therapy + Radiation Therapy~Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles~Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles~Weeks 18-26: total androgen suppression"
10783902|NCT00116142|OG000|Outcome|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen Suppression Therapy and Radiation Therapy~Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression"
10783903|NCT00116142|OG001|Outcome|Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy|"Docetaxel + Androgen Suppression Therapy and Radiation Therapy~Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles~Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles~Weeks 18-26: total androgen suppression"
10783904|NCT00116142|OG000|Outcome|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen suppression Therapy + Radiation Therapy~Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression"
10783905|NCT00116142|EG000|Reported Event|Arm1: Androgen Suppression Therapy + Radiation Therapy|"Androgen Suppression Therapy and Radiation therapy~Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy~Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy"
10783906|NCT00116142|EG001|Reported Event|Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy|"Docetaxel plus androgen suppression therapy and radiation therapy~Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.~Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy~Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy"
10783907|NCT00070018|BG000|Baseline|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
10783908|NCT00070018|FG000|Participant Flow|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
10783909|NCT00070018|OG000|Outcome|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
10783910|NCT00070018|EG000|Reported Event|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
10801856|NCT03312907|BG000|Baseline|Belimumab + Placebo|Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10801857|NCT03312907|BG001|Baseline|Belimumab + Rituximab|Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10801858|NCT03312907|BG002|Baseline|Belimumab + Standard Therapy|Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104.
10801859|NCT03312907|BG003|Baseline|Total|Total of all reporting groups
10801860|NCT03312907|FG000|Participant Flow|Belimumab + Placebo|Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10801861|NCT03312907|FG001|Participant Flow|Belimumab + Rituximab|Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10801862|NCT03312907|FG002|Participant Flow|Belimumab + Standard Therapy|Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104.
10801863|NCT03312907|OG000|Outcome|Belimumab + Placebo|Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10964636|NCT00878553|OG000|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11194198|NCT02151253|EG000|Reported Event|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
10783911|NCT04631796|BG000|Baseline|LID020098|Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
10783912|NCT04631796|FG000|Participant Flow|LID020098|Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
10783913|NCT04631796|OG000|Outcome|LID020098|Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
10783914|NCT04631796|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
10783915|NCT04631796|EG001|Reported Event|LID020098 Ocular|Events reported in this group occurred while exposed to the study contact lenses
10783916|NCT04631796|EG002|Reported Event|LID020098 Nonocular|Events reported in this group occurred while exposed to the study contact lenses
10783917|NCT04447287|BG000|Baseline|Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783918|NCT04447287|BG001|Baseline|ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
11194199|NCT02151253|EG001|Reported Event|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
11194200|NCT02151266|BG000|Baseline|Exercise and Cognitive Retraining|"Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up.~Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week."
11194201|NCT02151266|BG001|Baseline|Exercise Only|"Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes.~Exercise Only"
11194202|NCT02151266|BG002|Baseline|Stretching and Flexibility|"Stretching and flexibility movements; heart failure education; home visits; telephone follow-up.~Stretching and Flexibility"
11194203|NCT02151266|BG003|Baseline|Total|Total of all reporting groups
11194204|NCT02151266|FG000|Participant Flow|Exercise and Cognitive Retraining|"Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up.~Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week."
10783919|NCT04447287|BG002|Baseline|Placebo ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783920|NCT04447287|BG003|Baseline|Total|Total of all reporting groups
10783921|NCT04447287|FG000|Participant Flow|Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783922|NCT04447287|FG001|Participant Flow|ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783923|NCT04447287|FG002|Participant Flow|Placebo ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783924|NCT04447287|OG000|Outcome|Buprenorphine/Naloxone (Run-in Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783925|NCT04447287|OG001|Outcome|ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783926|NCT04447287|OG002|Outcome|ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783927|NCT04447287|OG003|Outcome|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
11240977|NCT02483572|FG000|Participant Flow|Functional Communication Training|"Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.~Functional Communication Training: Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention)"
11240978|NCT02483572|FG001|Participant Flow|Waitlist-Control Condition|Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).
11240979|NCT02483572|OG000|Outcome|Functional Communication Training|"Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.~Functional Communication Training: Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention)"
11240980|NCT02483572|OG001|Outcome|Waitlist-Control Condition|Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).
11240981|NCT02483572|EG000|Reported Event|Functional Communication Training|"Participants assigned to this condition will receive treatment immediately after assignment. The investigators will implement functional communication training (FCT) to teach the participant an appropriate request response, known as a functional communication response or FCR. FCT training will continue until the participant emits independent FCRs in at least 90% of the 30-s intervals and until destructive behavior decreases by 90% (relative to pre-treatment baseline) for two consecutive sessions.~Functional Communication Training: Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention)"
11240982|NCT02483572|EG001|Reported Event|Waitlist-Control Condition|Participants assigned to the waitlist-control condition will not immediately receive services. These participants will be paired with an FCT-condition participant such that the no-treatment duration for these participants is yoked to the amount of time their respective FCT-condition participants receive services (e.g., most treatment last approximately 4 months, or 16 weeks); if Participant A finishes treatment in 16 weeks, Participant B will not receive treatment for at least 16 weeks for comparative measures). After the wait period, these participants will then receive the same services as those assigned to the immediate treatment (FCT Condition).
11240983|NCT02483611|BG000|Baseline|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
11240984|NCT02483611|BG001|Baseline|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
11240985|NCT02483611|BG002|Baseline|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
11240986|NCT02483611|BG003|Baseline|Total|Total of all reporting groups
11240987|NCT02483611|FG000|Participant Flow|Group M (Magnesium Sulfate)|This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.
11240988|NCT02483611|FG001|Participant Flow|Group ML (Magnesium Sulfate Plus Lidocaine)|This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.
11240989|NCT02483611|FG002|Participant Flow|Group C (Control Group - Isotonic Solution)|This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
11240990|NCT02483611|OG000|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
10783928|NCT04447287|OG004|Outcome|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783929|NCT04447287|OG002|Outcome|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783930|NCT04447287|OG000|Outcome|ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783931|NCT04447287|OG001|Outcome|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783932|NCT04447287|OG000|Outcome|ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783933|NCT04447287|OG000|Outcome|Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783934|NCT04447287|OG001|Outcome|ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783935|NCT04447287|OG002|Outcome|Placebo ASP8062 in Combination With Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783936|NCT04447287|EG000|Reported Event|Buprenorphine/Naloxone|Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
11240991|NCT02483611|OG001|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
10783937|NCT04447287|EG001|Reported Event|ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783938|NCT04447287|EG002|Reported Event|ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783939|NCT04447287|EG003|Reported Event|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.
10783940|NCT04447287|EG004|Reported Event|Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)|Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
10783941|NCT04203537|BG000|Baseline|CA-008 36 mg|"Single administration~CA-008: Local administration during surgery"
10783942|NCT04203537|BG001|Baseline|CA-008 60 mg|"Single administration~CA-008: Local administration during surgery"
10783943|NCT04203537|BG002|Baseline|CA-008 90 mg|"Single administration~CA-008: Local administration during surgery"
10783944|NCT04203537|BG003|Baseline|Placebo|"Single administration~Placebo: Local administration during surgery"
10783945|NCT04203537|BG004|Baseline|Total|Total of all reporting groups
10783946|NCT04203537|FG000|Participant Flow|CA-008 36 mg (Patients From Part A)|"Single administration~CA-008 (vocacapsaicin): Local administration during surgery"
10783947|NCT04203537|FG001|Participant Flow|CA-008 60 mg (Patients From Part A)|"Single administration~CA-008 (vocacapsaicin): Local administration during surgery"
10783948|NCT04203537|FG002|Participant Flow|CA-008 90 mg (Patients From Part A)|"Single administration~CA-008 (vocacapsaicin): Local administration during surgery"
10783949|NCT04203537|FG003|Participant Flow|Placebo (Patients From Part A)|"Single administration~Placebo: Local administration during surgery"
10783950|NCT04203537|FG004|Participant Flow|CA-008 36 mg (Patients From Part B)|"Single administration~CA-008 (vocacapsaicin): Local administration during surgery"
10783951|NCT04203537|FG005|Participant Flow|CA-008 60 mg (Patients From Part B)|"Single administration~CA-008 (vocacapsaicin): Local administration during surgery"
10783952|NCT04203537|FG006|Participant Flow|Placebo (Patients From Part B)|"Single administration~Placebo: Local administration during surgery"
10783953|NCT04203537|OG000|Outcome|CA-008 36 mg (0.3 mg/mL Concentration)|"Single administration~CA-008: Local administration during surgery"
10783954|NCT04203537|OG001|Outcome|CA-008 60 mg (0.5 mg/mL Concentration)|"Single administration~CA-008: Local administration during surgery"
10783955|NCT04203537|OG002|Outcome|CA-008 90 mg (0.75 mg/mL Concentration)|"Single administration~CA-008: Local administration during surgery"
10783956|NCT04203537|OG003|Outcome|Placebo|"Single administration~Placebo: Local administration during surgery"
10783957|NCT04203537|EG000|Reported Event|CA-008 36 mg|"Single administration~CA-008: Local administration during surgery"
10783958|NCT04203537|EG001|Reported Event|CA-008 60 mg|"Single administration~CA-008: Local administration during surgery"
10783959|NCT04203537|EG002|Reported Event|CA-008 90 mg|"Single administration~CA-008: Local administration during surgery"
10783960|NCT04203537|EG003|Reported Event|Placebo|"Single administration~Placebo: Local administration during surgery"
10783961|NCT04125745|BG000|Baseline|CXA-10|"Oral CXA-10 300 mg once daily for 12 weeks~CXA-10: Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks"
10783962|NCT04125745|FG000|Participant Flow|CXA-10|"Oral CXA-10 300 mg once daily for 12 weeks~CXA-10: Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks"
10783963|NCT04125745|OG000|Outcome|CXA-10|"Oral CXA-10 300 mg once daily for 12 weeks~CXA-10: Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks"
10783964|NCT04125745|EG000|Reported Event|CXA-10|"Oral CXA-10 300 mg once daily for 12 weeks~CXA-10: Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks"
10783965|NCT04074928|BG000|Baseline|QIVc|Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783966|NCT04074928|BG001|Baseline|Comparator QIV|Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783967|NCT04074928|BG002|Baseline|Total|Total of all reporting groups
10783968|NCT04074928|FG000|Participant Flow|QIVc|Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783969|NCT04074928|FG001|Participant Flow|Comparator QIV|Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783970|NCT04074928|OG000|Outcome|QIVc|Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
11240992|NCT02483611|OG002|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
10783971|NCT04074928|OG001|Outcome|Comparator QIV|Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783972|NCT04074928|EG000|Reported Event|QIVc|Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783973|NCT04074928|EG001|Reported Event|Comparator QIV|Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
10783974|NCT04039503|BG000|Baseline|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10783975|NCT04039503|BG001|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10783976|NCT04039503|BG002|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10783977|NCT04039503|BG003|Baseline|Placebo|Placebo administered SC once a week.
10783978|NCT04039503|BG004|Baseline|Total|Total of all reporting groups
10783979|NCT04039503|FG000|Participant Flow|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10783980|NCT04039503|FG001|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10783981|NCT04039503|FG002|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10783982|NCT04039503|FG003|Participant Flow|Placebo|Placebo administered SC once a week.
10783983|NCT04039503|OG000|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10783984|NCT04039503|OG001|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10783985|NCT04039503|OG002|Outcome|Placebo|Placebo administered SC once a week.
10783986|NCT04039503|OG000|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered subcutaneously (SC) once a week.
10783987|NCT04039503|OG001|Outcome|Placebo|Placebo administered SC once a week.
10783988|NCT04039503|OG000|Outcome|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10783989|NCT04039503|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10783990|NCT04039503|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10783991|NCT04039503|OG003|Outcome|Placebo|Placebo administered SC once a week.
10783992|NCT04039503|EG000|Reported Event|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10783993|NCT04039503|EG001|Reported Event|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10783994|NCT04039503|EG002|Reported Event|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week.
10783995|NCT04039503|EG003|Reported Event|Placebo|Placebo administered SC once a week.
10801864|NCT03312907|OG001|Outcome|Belimumab + Rituximab|Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10783996|NCT03695172|BG000|Baseline|TAP Block|"Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~TAP block: Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10783997|NCT03695172|BG001|Baseline|QL Block|"Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~QL block: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10783998|NCT03695172|BG002|Baseline|ESP Block|"Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~ESP block: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side."
10783999|NCT03695172|BG003|Baseline|Total|Total of all reporting groups
10784000|NCT03695172|FG000|Participant Flow|TAP Block|"Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~TAP block: Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10964637|NCT00878553|OG001|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11194205|NCT02151266|FG001|Participant Flow|Exercise Only|"Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes.~Exercise Only"
11194206|NCT02151266|FG002|Participant Flow|Stretching and Flexibility|"Stretching and flexibility movements; heart failure education; home visits; telephone follow-up.~Stretching and Flexibility"
11194207|NCT02151266|OG000|Outcome|Exercise and Cognitive Retraining|"Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up.~Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week."
11194208|NCT02151266|OG001|Outcome|Exercise Only|"Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes.~Exercise Only"
11194209|NCT02151266|OG002|Outcome|Stretching and Flexibility|"Stretching and flexibility movements; heart failure education; home visits; telephone follow-up.~Stretching and Flexibility"
11194210|NCT02151266|EG000|Reported Event|Exercise and Cognitive Retraining|"Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up.~Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week."
11194211|NCT02151266|EG001|Reported Event|Exercise Only|"Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes.~Exercise Only"
11194212|NCT02151266|EG002|Reported Event|Stretching and Flexibility|"Stretching and flexibility movements; heart failure education; home visits; telephone follow-up.~Stretching and Flexibility"
11194213|NCT02151331|BG000|Baseline|REP + EF|"Replication Effective Programs (REP) augmented with External Facilitation (EF)~External Facilitation: Non-responding sites randomized to receive external facilitation"
10784001|NCT03695172|FG001|Participant Flow|QL Block|"Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~QL block: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10784002|NCT03695172|FG002|Participant Flow|ESP Block|"Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~ESP block: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side."
10784003|NCT03695172|OG000|Outcome|TAP Block|"Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~TAP block: Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10784004|NCT03695172|OG001|Outcome|QL Block|"Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~QL block: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
11240993|NCT02483611|EG000|Reported Event|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
11380726|NCT02275559|EG000|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.~Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses."
11380727|NCT02275559|EG001|Reported Event|Healthy Living Course (HLC)|"The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support~Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support"
11380732|NCT01332968|BG000|Baseline|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380733|NCT01332968|BG001|Baseline|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380734|NCT01332968|BG002|Baseline|Total|Total of all reporting groups
11380735|NCT01332968|FG000|Participant Flow|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380736|NCT01332968|FG001|Participant Flow|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380737|NCT01332968|FG002|Participant Flow|Rituximab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.
11380738|NCT01332968|FG003|Participant Flow|Obinutuzumab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.
11380739|NCT01332968|FG004|Participant Flow|Rituximab+Chemotherapy - Observation Period|Rituximab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
11380740|NCT01332968|FG005|Participant Flow|Obinutuzumab+Chemotherapy - Observation Period|Obinutuzumab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
11380741|NCT01332968|FG006|Participant Flow|Rituximab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
11380742|NCT01332968|FG007|Participant Flow|Obinutuzumab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
10784005|NCT03695172|OG002|Outcome|ESP Block|"Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~ESP block: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side."
10784006|NCT03695172|EG000|Reported Event|TAP Block|"Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~TAP block: Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10784007|NCT03695172|EG001|Reported Event|QL Block|"Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~QL block: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side."
10784008|NCT03695172|EG002|Reported Event|ESP Block|"Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.~Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine~ESP block: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side."
10784009|NCT03433040|BG000|Baseline|Non Obese|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784010|NCT03433040|BG001|Baseline|Obese - Control|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784011|NCT03433040|BG002|Baseline|Obese|"500mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784012|NCT03433040|BG003|Baseline|Total|Total of all reporting groups
10784013|NCT03433040|FG000|Participant Flow|Non Obese|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784014|NCT03433040|FG001|Participant Flow|Obese - Control|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784015|NCT03433040|FG002|Participant Flow|Obese|"500mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784016|NCT03433040|OG000|Outcome|Non Obese|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784017|NCT03433040|OG001|Outcome|Obese - Control|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784018|NCT03433040|OG002|Outcome|Obese|"500mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784019|NCT03433040|EG000|Reported Event|Non Obese|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784020|NCT03433040|EG001|Reported Event|Obese - Control|"250mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784021|NCT03433040|EG002|Reported Event|Obese|"500mg 17 OHP-C~17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg"
10784022|NCT03394027|BG000|Baseline|Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
10784023|NCT03394027|BG001|Baseline|Cohort 2-Triple Negative Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
10784024|NCT03394027|BG002|Baseline|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days
11194214|NCT02151331|BG001|Baseline|REP + EF/IF|"Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)~External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation"
10784025|NCT03394027|BG003|Baseline|Total|Total of all reporting groups
10784026|NCT03394027|FG000|Participant Flow|Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
10784027|NCT03394027|FG001|Participant Flow|Cohort 2-Triple Negative Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
10784028|NCT03394027|FG002|Participant Flow|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days
10784029|NCT03394027|OG000|Outcome|Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days.
10784030|NCT03394027|OG000|Outcome|Cohort 2-Triple Negative Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days.
10784031|NCT03394027|OG000|Outcome|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days.
10784032|NCT03394027|OG000|Outcome|Cohort 1 - Grade 1|Grade 1 is mild.
10784033|NCT03394027|OG001|Outcome|Cohort 1 - Grade 2|Grade 2 is moderate.
10784034|NCT03394027|OG002|Outcome|Cohort 1 - Grade 3|Grade 3 is severe.
10784035|NCT03394027|OG003|Outcome|Cohort 1 - Grade 4|Grade 4 is life-threatening.
10784036|NCT03394027|OG004|Outcome|Cohort 1 - Grade 5|Grade 5 is death related to adverse event.
10784037|NCT03394027|OG005|Outcome|Cohort 2 - Grade 1|Grade 1 is mild.
10784038|NCT03394027|OG006|Outcome|Cohort 2 - Grade 2|Grade 2 is moderate.
10784039|NCT03394027|OG007|Outcome|Cohort 2 - Grade 3|Grade 3 is severe.
10784040|NCT03394027|OG008|Outcome|Cohort 2 - Grade 4|Grade 4 is life-threatening.
10784041|NCT03394027|OG009|Outcome|Cohort 2 - Grade 5|Grade 5 is death related to adverse event.
10784042|NCT03394027|OG010|Outcome|Cohort 3 - Grade 1|Grade 1 is mild.
10784043|NCT03394027|OG011|Outcome|Cohort 3 - Grade 2|Grade 2 is moderate.
10784044|NCT03394027|OG012|Outcome|Cohort 3 - Grade 3|Grade 3 is severe.
10784045|NCT03394027|OG013|Outcome|Cohort 3 - Grade 4|Grade 4 is life-threatening.
10784046|NCT03394027|OG014|Outcome|Cohort 3 - Grade 5|Grade 5 is death related to adverse event.
10784047|NCT03394027|OG001|Outcome|Cohort 2-Triple Negative Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days.
10784048|NCT03394027|OG002|Outcome|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days.
10784049|NCT03394027|OG001|Outcome|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days.
10784050|NCT03394027|EG000|Reported Event|Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
10784051|NCT03394027|EG001|Reported Event|Cohort 2-Triple Negative Breast Cancer (Male and Female)|625mg ONC201 by mouth every 7 days
11194215|NCT02151331|BG002|Baseline|Total|Total of all reporting groups
10784052|NCT03394027|EG002|Reported Event|Cohort 3-Endometrial Cancer (Female Only)|625mg ONC201 by mouth every 7 days
10784053|NCT03357952|BG000|Baseline|Part 1: Daratumumab + JNJ-63723283|Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784054|NCT03357952|BG001|Baseline|Part 2: Daratumumab (Arm A)|Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784055|NCT03357952|BG002|Baseline|Total|Total of all reporting groups
10784056|NCT03357952|FG000|Participant Flow|Part 1: Daratumumab + JNJ-63723283|Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784057|NCT03357952|FG001|Participant Flow|Part 2: Daratumumab (Arm A)|Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784058|NCT03357952|OG000|Outcome|Part 1: Daratumumab + JNJ-63723283|Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784059|NCT03357952|OG000|Outcome|Part 2: Daratumumab (Arm A)|Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784060|NCT03357952|EG000|Reported Event|Part 1: Daratumumab + JNJ-63723283|Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784061|NCT03357952|EG001|Reported Event|Part 2: Daratumumab (Arm A)|Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
10784062|NCT03237234|BG000|Baseline|Motor Skill Training + Sham tDCS (MST+Sham-tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (sham-tDCS).~MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test."
10784063|NCT03237234|BG001|Baseline|Motor Skill Training + tDCS (MST+tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (tDCS) delivered at 2mA to the motor cortex.~MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.~Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities."
10784064|NCT03237234|BG002|Baseline|Total|Total of all reporting groups
10801865|NCT03312907|OG002|Outcome|Belimumab + Standard Therapy|Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104.
11194216|NCT02151331|FG000|Participant Flow|REP + EF|"Replication Effective Programs (REP) augmented with External Facilitation (EF)~External Facilitation: Non-responding sites randomized to receive external facilitation"
10784065|NCT03237234|FG000|Participant Flow|Motor Skill Training + Sham tDCS (MST+Sham-tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).~Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test."
10784066|NCT03237234|FG001|Participant Flow|Motor Skill Training + tDCS (MST+tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.~MST: Motor skill training will consist of activities performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.~Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA."
10784067|NCT03237234|OG000|Outcome|Motor Skill Training + Sham tDCS (MST+Sham-tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).~Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test."
10784068|NCT03237234|OG001|Outcome|Motor Skill Training + tDCS (MST+tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.~Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.~Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities."
10784069|NCT03237234|EG000|Reported Event|Motor Skill Training + Sham tDCS (MST+Sham-tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).~MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test."
10801866|NCT03312907|EG000|Reported Event|Belimumab + Placebo|Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
10801867|NCT03312907|EG001|Reported Event|Belimumab + Rituximab|Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.
11240994|NCT02483611|EG001|Reported Event|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
10784070|NCT03237234|EG001|Reported Event|Motor Skill Training + tDCS (MST+tDCS)|"Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.~Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.~Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities."
10784071|NCT03170869|BG000|Baseline|DEB-TACE Procedure With Surefire Precision Infusion System|"The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.~The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.~The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.~The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire."
10784072|NCT03170869|FG000|Participant Flow|DEB-TACE Procedure With Surefire Precision Infusion System|"The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.~The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.~The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.~The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire."
10784073|NCT03170869|OG000|Outcome|DEB-TACE Procedure With Surefire Precision Infusion System|"The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.~The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.~The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed.~The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire."
10784074|NCT03170869|OG000|Outcome|DEB-TACE Procedure With Surefire Precision Infusion System|"The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.~The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.~The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.~The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire."
10784075|NCT03170869|EG000|Reported Event|DEB-TACE Procedure With Surefire Precision Infusion System|"The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death.~The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire.~The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring.~The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire."
10784076|NCT03066622|BG000|Baseline|Standard of Care|Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician)
11194217|NCT02151331|FG001|Participant Flow|REP + EF/IF|"Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)~External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation"
11194218|NCT02151331|OG000|Outcome|REP + EF|"Replication Effective Programs (REP) augmented with External Facilitation (EF)~External Facilitation: Non-responding sites randomized to receive external facilitation"
10784077|NCT03066622|BG001|Baseline|Olanzapine|"oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.~5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine"
10784078|NCT03066622|BG002|Baseline|Total|Total of all reporting groups
10784079|NCT03066622|FG000|Participant Flow|Standard of Care|Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician)
10784080|NCT03066622|FG001|Participant Flow|Olanzapine|"oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.~5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine"
10784081|NCT03066622|OG000|Outcome|Standard of Care|Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician)
10784082|NCT03066622|OG001|Outcome|Olanzapine|"oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.~5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine"
10784083|NCT03066622|EG000|Reported Event|Standard of Care|Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician)
10784084|NCT03066622|EG001|Reported Event|Olanzapine|"oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.~5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine"
10784085|NCT03052920|BG000|Baseline|Cochlear Implantation|"Cochlear implantation of the poor hearing ear~Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear."
10784086|NCT03052920|FG000|Participant Flow|Cochlear Implantation|"Cochlear implantation of the poor hearing ear~Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear."
10784087|NCT03052920|OG000|Outcome|Cochlear Implantation|"Cochlear implantation of the poor hearing ear~Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear."
10784088|NCT03052920|EG000|Reported Event|Cochlear Implantation|"Cochlear implantation of the poor hearing ear~Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear."
10784089|NCT03029104|BG000|Baseline|Group 1|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784090|NCT03029104|BG001|Baseline|Group 2|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784091|NCT03029104|BG002|Baseline|Group 3|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784092|NCT03029104|BG003|Baseline|Total|Total of all reporting groups
11194219|NCT02151331|OG001|Outcome|REP + EF/IF|"Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)~External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation"
10784093|NCT03029104|FG000|Participant Flow|Group 1|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784094|NCT03029104|FG001|Participant Flow|Group 2|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784095|NCT03029104|FG002|Participant Flow|Group 3|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784096|NCT03029104|OG000|Outcome|Group 1|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784097|NCT03029104|OG001|Outcome|Group 2|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784098|NCT03029104|OG002|Outcome|Group 3|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784099|NCT03029104|EG000|Reported Event|Group 1|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
11194220|NCT02151331|EG000|Reported Event|REP + EF|"Replication Effective Programs (REP) augmented with External Facilitation (EF)~External Facilitation: Non-responding sites randomized to receive external facilitation"
11194221|NCT02151331|EG001|Reported Event|REP + EF/IF|"Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)~External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation"
11194222|NCT02151448|BG000|Baseline|α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen|"Phase 1:~α DC1 vaccine and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)~Phase 2:~α DC1 vaccine and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 20 MU/m^2 (T-Fri)"
11194223|NCT02151448|FG000|Participant Flow|α DC1 Vaccine + Chemokine Modulatory Regimen|"Phase 1:~α DC1 vaccine and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)~Phase 2 α DC1 vaccine and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 20 MU/m^2 (T-Fri)"
10784100|NCT03029104|EG001|Reported Event|Group 2|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
11194224|NCT02151448|OG000|Outcome|Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen|"α DC1 vaccine and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m^2, 10 MU/m^2 or 20 MU/m^2 (T-Fri)"
11194225|NCT02151448|OG000|Outcome|α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen|"α DC1 Vaccine~and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)"
11194226|NCT02151448|OG000|Outcome|α DC1 Vaccine + Chemokine Modulatory Regimen|"α DC1 Vaccine~and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)"
11194227|NCT02151448|OG000|Outcome|α DC1 Vaccine + Chemokine Modulatory Regimen|"α DC1 vaccine~and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)"
11194228|NCT02151448|OG000|Outcome|α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen|"α DC1 vaccine~and~Chemokine Modulatory Regimen:~Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed & and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m^2 or 20 MU/m^2 (T-Fri)"
11194229|NCT02151448|EG000|Reported Event|Vaccine + Chemokine Modulatory Regimen|Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before & after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days & CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed & Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed & Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed & Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.
11194230|NCT02151461|BG000|Baseline|FDC125|Leucine 1100mg +Metformin 125mg
11194231|NCT02151461|BG001|Baseline|FDC250|Leucine 1100mg +Metformin 250mg
11194232|NCT02151461|BG002|Baseline|FDC500|Leucine 1100mg +Metformin 500mg
11194233|NCT02151461|BG003|Baseline|Control|Day 1-14: 500mg, Day 15-28: 850mg
11194234|NCT02151461|BG004|Baseline|Total|Total of all reporting groups
11194235|NCT02151461|FG000|Participant Flow|FDC125|Leucine 1100mg +Metformin 125mg
11194236|NCT02151461|FG001|Participant Flow|FDC250|Leucine 1100mg +Metformin 250mg
11194237|NCT02151461|FG002|Participant Flow|FDC500|Leucine 1100mg +Metformin 500mg
11194238|NCT02151461|FG003|Participant Flow|Control|Day 1-14: 500mg, Day 15-28: 850mg
11194239|NCT02151461|OG000|Outcome|FDC125|Leucine 1100mg +Metformin 125mg
11194240|NCT02151461|OG001|Outcome|FDC250|Leucine 1100mg +Metformin 250mg
11194241|NCT02151461|OG002|Outcome|FDC500|Leucine 1100mg +Metformin 500mg
11194242|NCT02151461|OG003|Outcome|Control|Day 1-14: 500mg, Day 15-28: 850mg
11194243|NCT02151461|EG000|Reported Event|FDC125|Leucine 1100mg +Metformin 125mg
11194244|NCT02151461|EG001|Reported Event|FDC250|Leucine 1100mg +Metformin 250mg
11194245|NCT02151461|EG002|Reported Event|FDC500|Leucine 1100mg +Metformin 500mg
11194246|NCT02151461|EG003|Reported Event|Control|Day 1-14: 500mg, Day 15-28: 850mg
11194247|NCT02151487|BG000|Baseline|Ropivacaine|"Ropivacaine 0.5% 25 ml alone for supraclavicular block~Ropivacaine: Ropivacaine alone"
11194248|NCT02151487|BG001|Baseline|Ropivacaine and Dexamethasone|"25 ml 0.5% ropivacaine + 4 mg dexamethasone~Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone"
11194249|NCT02151487|BG002|Baseline|Ropivacaine and Clonidine|"25 ml 0.5% ropivacaine + 100 mcg clonidine~Ropivacaine and clonidine: Ropivacaine combination with clonidine"
11194250|NCT02151487|BG003|Baseline|Ropivacaine, Dexamethasone and Clonidine|"25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine~Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine"
11194251|NCT02151487|BG004|Baseline|Total|Total of all reporting groups
11194252|NCT02151487|FG000|Participant Flow|Ropivacaine|"Ropivacaine 0.5% 25 ml alone for supraclavicular block~Ropivacaine: Ropivacaine alone"
11194253|NCT02151487|FG001|Participant Flow|Ropivacaine and Dexamethasone|"25 ml 0.5% ropivacaine + 4 mg dexamethasone~Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone"
10784101|NCT03029104|EG002|Reported Event|Group 3|"Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.~CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution"
10784102|NCT03016312|BG000|Baseline|Atezolizumab + Enzalutamide|Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784103|NCT03016312|BG001|Baseline|Enzalutamide|Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784104|NCT03016312|BG002|Baseline|Total|Total of all reporting groups
10784105|NCT03016312|FG000|Participant Flow|Atezolizumab + Enzalutamide|Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784106|NCT03016312|FG001|Participant Flow|Enzalutamide|Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784107|NCT03016312|OG000|Outcome|Atezolizumab + Enzalutamide|Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784108|NCT03016312|OG001|Outcome|Enzalutamide|Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784109|NCT03016312|EG000|Reported Event|Atezolizumab + Enzalutamide|Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
10784110|NCT03016312|EG001|Reported Event|Enzalutamide|Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
11194254|NCT02151487|FG002|Participant Flow|Ropivacaine and Clonidine|"25 ml 0.5% ropivacaine + 100 mcg clonidine~Ropivacaine and clonidine: Ropivacaine combination with clonidine"
10784111|NCT02876172|BG000|Baseline|Patient MDMA and CBCT|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784112|NCT02876172|BG001|Baseline|Partner MDMA and CBCT|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784113|NCT02876172|BG002|Baseline|Total|Total of all reporting groups
11194255|NCT02151487|FG003|Participant Flow|Ropivacaine, Dexamethasone and Clonidine|"25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine~Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine"
11194256|NCT02151487|OG000|Outcome|Ropivacaine|"Ropivacaine 0.5% 25 ml alone for supraclavicular block~Ropivacaine: Ropivacaine alone"
10784114|NCT02876172|FG000|Participant Flow|Patient MDMA and CBCT|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784115|NCT02876172|FG001|Participant Flow|Partner MDMA and CBCT|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784116|NCT02876172|OG000|Outcome|MDMA (75 mg or 100 mg) + CBCT|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784117|NCT02876172|EG000|Reported Event|PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10801868|NCT03312907|EG002|Reported Event|Belimumab + Standard Therapy|Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of <= 5 mg/day until Week 104.
10784118|NCT02876172|EG001|Reported Event|CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784119|NCT02876172|EG002|Reported Event|PTSD Patients at 6-month Follow-up|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784120|NCT02876172|EG003|Reported Event|CSO Patients at 6-month Follow-up|"Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.~MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.~CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual~Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual)"
10784121|NCT02722434|BG000|Baseline|Arm I (MC5-A Scrambler Therapy)|Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
10784122|NCT02722434|BG001|Baseline|Arm II (TENS Therapy)|Patients undergo TENS therapy over 30 minutes daily for 14 days.
10784123|NCT02722434|BG002|Baseline|Total|Total of all reporting groups
10784124|NCT02722434|FG000|Participant Flow|Arm I (MC5-A Scrambler Therapy)|Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
10784125|NCT02722434|FG001|Participant Flow|Arm II (TENS Therapy)|Patients undergo TENS therapy over 30 minutes daily for 14 days.
10784126|NCT02722434|OG000|Outcome|Arm I (MC5-A Scrambler Therapy)|Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
10784127|NCT02722434|OG001|Outcome|Arm II (TENS Therapy)|Patients undergo TENS therapy over 30 minutes daily for 14 days.
10784128|NCT02722434|EG000|Reported Event|Arm I (MC5-A Scrambler Therapy)|Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
10784129|NCT02722434|EG001|Reported Event|Arm II (TENS Therapy)|Patients undergo TENS therapy over 30 minutes daily for 14 days.
10784130|NCT02721979|BG000|Baseline|Treatment (Apalutamide)|"Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.~Apalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10784131|NCT02721979|FG000|Participant Flow|Apalutamide|"Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.~Apalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10784132|NCT02721979|OG000|Outcome|Apalutamide|"Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.~Apalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10784133|NCT02721979|EG000|Reported Event|Apalutamide|"Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.~Apalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10784134|NCT02604511|BG000|Baseline|Ibrutinib|"This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.~Ibrutinib"
10784135|NCT02604511|FG000|Participant Flow|Ibrutinib|"This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.~Ibrutinib"
10784136|NCT02604511|OG000|Outcome|Ibrutinib|"This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.~Ibrutinib"
10784137|NCT02604511|EG000|Reported Event|Ibrutinib|"This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.~Ibrutinib"
11194257|NCT02151487|OG001|Outcome|Ropivacaine and Dexamethasone|"25 ml 0.5% ropivacaine + 4 mg dexamethasone~Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone"
11194258|NCT02151487|OG002|Outcome|Ropivacaine and Clonidine|"25 ml 0.5% ropivacaine + 100 mcg clonidine~Ropivacaine and clonidine: Ropivacaine combination with clonidine"
10784138|NCT02369536|BG000|Baseline|Nutraceutical Mixture|"Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)~nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)"
10801869|NCT03148756|BG000|Baseline|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
10784139|NCT02369536|BG001|Baseline|Placebo|"Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)~placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture"
10784140|NCT02369536|BG002|Baseline|Total|Total of all reporting groups
10801870|NCT03148756|BG001|Baseline|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11194259|NCT02151487|OG003|Outcome|Ropivacaine, Dexamethasone and Clonidine|"25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine~Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine"
11194260|NCT02151487|EG000|Reported Event|Ropivacaine|"Ropivacaine 0.5% 25 ml alone for supraclavicular block~Ropivacaine: Ropivacaine alone"
11194261|NCT02151487|EG001|Reported Event|Ropivacaine and Dexamethasone|"25 ml 0.5% ropivacaine + 4 mg dexamethasone~Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone"
11194262|NCT02151487|EG002|Reported Event|Ropivacaine and Clonidine|"25 ml 0.5% ropivacaine + 100 mcg clonidine~Ropivacaine and clonidine: Ropivacaine combination with clonidine"
11194263|NCT02151487|EG003|Reported Event|Ropivacaine, Dexamethasone and Clonidine|"25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine~Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine"
11194264|NCT02151591|BG000|Baseline|Integrated Counseling for Tobacco and Alcohol (INT)|"Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194265|NCT02151591|BG001|Baseline|Standard Care for Primary Presenting Concern (SC)|"Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194266|NCT02151591|BG002|Baseline|Total|Total of all reporting groups
11194267|NCT02151591|FG000|Participant Flow|Integrated Counseling for Tobacco and Alcohol (INT)|"Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194268|NCT02151591|FG001|Participant Flow|Standard Care for Primary Presenting Concern (SC)|"Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194269|NCT02151591|OG000|Outcome|Integrated Counseling for Tobacco and Alcohol (INT)|"Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194270|NCT02151591|OG001|Outcome|Standard Care for Primary Presenting Concern (SC)|"Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194271|NCT02151591|EG000|Reported Event|Integrated Counseling for Tobacco and Alcohol (INT)|"Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194272|NCT02151591|EG001|Reported Event|Standard Care for Primary Presenting Concern (SC)|"Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix).~Varenicline: 12-weeks of treatment. Dose will be titrated as follows:~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
11194273|NCT02151643|BG000|Baseline|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194274|NCT02151643|BG001|Baseline|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194275|NCT02151643|BG002|Baseline|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
10784141|NCT02369536|FG000|Participant Flow|Nutraceutical Mixture|"Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)~nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)"
10784142|NCT02369536|FG001|Participant Flow|Placebo|"Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)~placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture"
10784143|NCT02369536|OG000|Outcome|Nutraceutical Mixture|
10784144|NCT02369536|OG001|Outcome|Placebo|
10784145|NCT02369536|OG000|Outcome|Nutraceutical Mixture|"Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)~nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)"
10784146|NCT02369536|OG001|Outcome|Placebo|"Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)~placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture"
10784147|NCT02369536|EG000|Reported Event|Nutraceutical Mixture|"Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)~nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)"
10784148|NCT02369536|EG001|Reported Event|Placebo|"Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)~placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture"
10784149|NCT02358681|BG000|Baseline|Ketorolac, Intranasal|"Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.~Placebo, intravenous.~Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.~Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route."
10784150|NCT02358681|BG001|Baseline|Ketorolac, Intravenous|"Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.~Placebo, intranasal.~Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.~Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route."
10784151|NCT02358681|BG002|Baseline|Total|Total of all reporting groups
10784152|NCT02358681|FG000|Participant Flow|Ketorolac, Intranasal|"Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.~Placebo, intravenous.~Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.~Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route."
10784153|NCT02358681|FG001|Participant Flow|Ketorolac, Intravenous|"Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.~Placebo, intranasal.~Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.~Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route."
10784154|NCT02358681|OG000|Outcome|Ketorolac, Intranasal|"Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.~Placebo, intravenous.~Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.~Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route."
10784155|NCT02358681|OG001|Outcome|Ketorolac, Intravenous|"Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.~Placebo, intranasal.~Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.~Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route."
10784156|NCT02358681|EG000|Reported Event|Ketorolac, Intranasal|"Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.~Placebo, intravenous.~Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.~Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route."
10784157|NCT02358681|EG001|Reported Event|Ketorolac, Intravenous|"Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.~Placebo, intranasal.~Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.~Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route."
10784158|NCT02101788|BG000|Baseline|Arm A - Control Arm|Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
10784159|NCT02101788|BG001|Baseline|Arm B - Experimental Arm|Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
10784160|NCT02101788|BG002|Baseline|Total|Total of all reporting groups
10784161|NCT02101788|FG000|Participant Flow|Arm A - Control Arm|Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
10784162|NCT02101788|FG001|Participant Flow|Arm B - Experimental Arm|Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
10784163|NCT02101788|OG000|Outcome|Arm A - Control Arm|Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
11194276|NCT02151643|BG003|Baseline|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194277|NCT02151643|BG004|Baseline|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194278|NCT02151643|BG005|Baseline|Total|Total of all reporting groups
11194279|NCT02151643|FG000|Participant Flow|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally~PT20: Modified ferric oxide adipate"
11194280|NCT02151643|FG001|Participant Flow|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally~PT20: Modified ferric oxide adipate"
11380743|NCT01332968|OG000|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
11380744|NCT01332968|OG001|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
11380745|NCT01332968|OG000|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380746|NCT01332968|OG001|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
11380747|NCT01332968|EG000|Reported Event|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
11194281|NCT02151643|FG002|Participant Flow|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally~PT20: Modified ferric oxide adipate"
10784164|NCT02101788|OG001|Outcome|Arm B - Experimental Arm|Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
10801871|NCT03148756|BG002|Baseline|Total|Total of all reporting groups
11194282|NCT02151643|FG003|Participant Flow|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally~PT20: Modified ferric oxide adipate"
11194283|NCT02151643|FG004|Participant Flow|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally~Placebo: Placebo tablets matched to each active PT20 dosage arm"
11194284|NCT02151643|OG000|Outcome|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194285|NCT02151643|OG001|Outcome|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194286|NCT02151643|OG002|Outcome|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194287|NCT02151643|OG003|Outcome|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194288|NCT02151643|OG004|Outcome|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
10784165|NCT02101788|OG000|Outcome|Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)|"Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B.~Letrozole: Given PO~Paclitaxel: Given IV~Pegylated Liposomal Doxorubicin Hydrochloride: Given IV~Quality-of-Life Assessment: Ancillary studies~Tamoxifen: Given PO~Tamoxifen Citrate: Given PO~Topotecan: Given IV~Topotecan Hydrochloride: Given IV"
10784166|NCT02101788|OG001|Outcome|Arm B (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Quality-of-Life Assessment: Ancillary studies~Trametinib: Given PO~Trametinib Dimethyl Sulfoxide: Given PO"
10784167|NCT02101788|OG000|Outcome|KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (Trametinib)|KRAS/BRAF/NRAS mutant group (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
10784168|NCT02101788|OG001|Outcome|KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (SOC)|KRAS/BRAF/NRAS mutant group (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
10784169|NCT02101788|OG002|Outcome|KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib)|KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
10784170|NCT02101788|OG003|Outcome|KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC)|KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
10784171|NCT02101788|EG000|Reported Event|Arm A - Control Arm|Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
10784172|NCT02101788|EG001|Reported Event|Arm B - Experimental Arm|Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
10784173|NCT02101788|EG002|Reported Event|Crossover From Control to Experimental Arm|Patients randomized to the control arm who crossed over to the experimental arm after disease progression.
11194289|NCT02151643|EG000|Reported Event|Group 1 - PT20 400 mg Tid|"PT20 400 mg tid (1.2 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194290|NCT02151643|EG001|Reported Event|Group 2 - PT20 800 mg Tid|"PT20 800 mg tid (2.4 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194291|NCT02151643|EG002|Reported Event|Group 3 - PT20 1600 mg Tid|"PT20 1600 mg tid (4.8 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
10784174|NCT01963728|BG000|Baseline|Insulin Isophane|"daily dose will be titrated based on fasting morning glucose values~Insulin, Isophane: daily dosing based on fasting morning glucose levels"
10784175|NCT01963728|BG001|Baseline|Insulin Glargine|"daily dose will be titrated based on fasting morning glucose values~insulin glargine: daily dose based on fasting morning glucose levels"
10784176|NCT01963728|BG002|Baseline|Total|Total of all reporting groups
10784177|NCT01963728|FG000|Participant Flow|Insulin Isophane|"daily dose will be titrated based on fasting morning glucose values~Insulin, Isophane: daily dosing based on fasting morning glucose levels"
10784178|NCT01963728|FG001|Participant Flow|Insulin Glargine|"daily dose will be titrated based on fasting morning glucose values~insulin glargine: daily dose based on fasting morning glucose levels"
11194292|NCT02151643|EG003|Reported Event|Group 4 - PT20 3200 mg Tid|"PT20 3200 mg tid (9.6 g/day) administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
11194293|NCT02151643|EG004|Reported Event|Group 5 - Placebo Tid|"Matched Placebo (for PT20) tid administered orally.~Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study"
10784179|NCT01963728|OG000|Outcome|Insulin Isophane|"daily dose will be titrated based on fasting morning glucose values~Insulin, Isophane: daily dosing based on fasting morning glucose levels"
10784180|NCT01963728|OG001|Outcome|Insulin Glargine|"daily dose will be titrated based on fasting morning glucose values~insulin glargine: daily dose based on fasting morning glucose levels"
10784181|NCT01963728|EG000|Reported Event|Insulin Isophane|"daily dose will be titrated based on fasting morning glucose values~Insulin, Isophane: daily dosing based on fasting morning glucose levels"
10784182|NCT01963728|EG001|Reported Event|Insulin Glargine|"daily dose will be titrated based on fasting morning glucose values~insulin glargine: daily dose based on fasting morning glucose levels"
10801872|NCT03148756|FG000|Participant Flow|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
10801873|NCT03148756|FG001|Participant Flow|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
10801874|NCT03148756|OG000|Outcome|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
10801875|NCT03148756|OG001|Outcome|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
10801876|NCT03148756|EG000|Reported Event|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
10784183|NCT01248247|BG000|Baseline|Arm 1 - Erlotinib|Erlotinib 150 mg by mouth each day of a 28 day cycle.
10784184|NCT01248247|BG001|Baseline|Arm 2 - Erlotinib + MK-2206|Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle.
10784185|NCT01248247|BG002|Baseline|Arm 3 - AZD6244 + MK-2206|AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
10784186|NCT01248247|BG003|Baseline|Arm 4 - Sorafenib|Sorafenib 400 mg by mouth twice a day for a 28 day cycle.
10784187|NCT01248247|BG004|Baseline|Total|Total of all reporting groups
10784188|NCT01248247|FG000|Participant Flow|Arm 1 - Erlotinib|Erlotinib 150 mg by mouth each day of a 28 day cycle.
10784189|NCT01248247|FG001|Participant Flow|Arm 2 - Erlotinib + MK-2206|Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle.
10784190|NCT01248247|FG002|Participant Flow|Arm 3 - AZD6244 + MK-2206|AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
10784191|NCT01248247|FG003|Participant Flow|Arm 4 - Sorafenib|Sorafenib 400 mg by mouth twice a day for a 28 day cycle.
10784192|NCT01248247|OG000|Outcome|Arm 1 - Erlotinib|Erlotinib 150 mg by mouth each day of a 28 day cycle.
10784193|NCT01248247|OG001|Outcome|Arm 2 - Erlotinib + MK-2206|Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle.
10784194|NCT01248247|OG002|Outcome|Arm 3 - AZD6244 + MK-2206|AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
10784195|NCT01248247|OG003|Outcome|Arm 4 - Sorafenib|Sorafenib 400 mg by mouth twice a day for a 28 day cycle.
10784196|NCT01248247|EG000|Reported Event|Arm 1 - Erlotinib|Erlotinib 150 mg by mouth each day of a 28 day cycle.
11240995|NCT02483611|EG002|Reported Event|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
10784197|NCT01248247|EG001|Reported Event|Arm 2 - Erlotinib + MK-2206|Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle.
10784198|NCT01248247|EG002|Reported Event|Arm 3 - AZD6244 + MK-2206|AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
10784199|NCT01248247|EG003|Reported Event|Arm 4 - Sorafenib|Sorafenib 400 mg by mouth twice a day for a 28 day cycle.
10784200|NCT01164228|BG000|Baseline|Arm A (Sunitinib + Gemcitabine)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784201|NCT01164228|BG001|Baseline|Arm B (Sunitinib)|Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784202|NCT01164228|BG002|Baseline|Total|Total of all reporting groups
10784203|NCT01164228|FG000|Participant Flow|Arm A (Sunitinib + Gemcitabine)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784204|NCT01164228|FG001|Participant Flow|Arm B (Sunitinib)|Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784205|NCT01164228|OG000|Outcome|Arm A (Sunitinib + Gemcitabine)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784206|NCT01164228|OG001|Outcome|Arm B (Sunitinib)|Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784207|NCT01164228|EG000|Reported Event|Arm A (Sunitinib + Gemcitabine)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784208|NCT01164228|EG001|Reported Event|Arm B (Sunitinib)|Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
10784209|NCT01012167|BG000|Baseline|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
10784210|NCT01012167|BG001|Baseline|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
10784211|NCT01012167|BG002|Baseline|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
10784212|NCT01012167|BG003|Baseline|Total|Total of all reporting groups
10784213|NCT01012167|FG000|Participant Flow|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
10784214|NCT01012167|FG001|Participant Flow|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
10784215|NCT01012167|FG002|Participant Flow|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
10784216|NCT01012167|OG000|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
10784217|NCT01012167|OG001|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
10784218|NCT01012167|OG002|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
10784219|NCT01012167|OG000|Outcome|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
10784220|NCT01012167|OG001|Outcome|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
10784221|NCT01012167|OG002|Outcome|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
10784222|NCT01012167|OG002|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
10784223|NCT01012167|OG000|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
10784224|NCT01012167|OG001|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
10784225|NCT01012167|OG002|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
10784226|NCT01012167|EG000|Reported Event|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
10784227|NCT01012167|EG001|Reported Event|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
10784228|NCT01012167|EG002|Reported Event|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
10784229|NCT00924326|BG000|Baseline|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784230|NCT00924326|BG001|Baseline|0.5x10^7 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784231|NCT00924326|BG002|Baseline|2.5x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784232|NCT00924326|BG003|Baseline|1.0x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784233|NCT00924326|BG004|Baseline|1.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784234|NCT00924326|BG005|Baseline|2.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784235|NCT00924326|BG006|Baseline|6.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784236|NCT00924326|BG007|Baseline|2.0x10^6 Cells/kg (Moderate Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784237|NCT00924326|BG008|Baseline|2.0x10^6 Cells/kg (9-12 Days Culture)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784238|NCT00924326|BG009|Baseline|Total|Total of all reporting groups
10784239|NCT00924326|FG000|Participant Flow|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784240|NCT00924326|FG001|Participant Flow|0.5x10^7 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784241|NCT00924326|FG002|Participant Flow|2.5x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784242|NCT00924326|FG003|Participant Flow|1.0x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10801877|NCT03148756|EG001|Reported Event|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11240996|NCT02483676|BG000|Baseline|Treadmill+Anklebot|"This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.~Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period."
11380748|NCT01332968|EG001|Reported Event|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
11380749|NCT01231906|BG000|Baseline|Arm A (Combination Chemotherapy)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9."
11380750|NCT01231906|BG001|Baseline|Arm B (Combination Chemotherapy, Topotecan Hydrochloride)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19."
11380751|NCT01231906|BG002|Baseline|Total|Total of all reporting groups
11380752|NCT01231906|FG000|Participant Flow|Arm A (Combination Chemotherapy)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9."
11380753|NCT01231906|FG001|Participant Flow|Arm B (Combination Chemotherapy, Topotecan Hydrochloride)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19."
11380754|NCT01231906|OG000|Outcome|Arm A (Combination Chemotherapy)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9."
11380755|NCT01231906|OG001|Outcome|Arm B (Combination Chemotherapy, Topotecan Hydrochloride)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19."
10784243|NCT00924326|FG004|Participant Flow|1.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784244|NCT00924326|FG005|Participant Flow|2.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784245|NCT00924326|FG006|Participant Flow|6.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784246|NCT00924326|FG007|Participant Flow|2.0x10^6 Cells/kg (Moderate Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784247|NCT00924326|FG008|Participant Flow|2.0x10^6 Cells/kg (9-12 Days Culture)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784248|NCT00924326|OG000|Outcome|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784249|NCT00924326|OG001|Outcome|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784250|NCT00924326|OG002|Outcome|0.5x10^7 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784251|NCT00924326|OG003|Outcome|2.5x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784252|NCT00924326|OG004|Outcome|1.0x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784253|NCT00924326|OG005|Outcome|1.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784254|NCT00924326|OG006|Outcome|2.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
11194294|NCT02151682|BG000|Baseline|Morphine Prolonged-release (Part 1)|"The treatment group comprised 7 participants aged 6 years to less than 12 years and 17 participants aged 12 years to less than 18 years.~Starting doses varied from 10 to 40 milligrams (mg) morphine PR twice daily depending on participant's weight; if necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 200 mg per day."
11194295|NCT02151682|BG001|Baseline|Tapentadol Prolonged-release (Part 1)|"The treatment group comprised 12 participants aged 6 years to less than 12 years and 33 participants aged 12 years to less than 18 years.~Starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11194296|NCT02151682|BG002|Baseline|Total|Total of all reporting groups
11194297|NCT02151682|FG000|Participant Flow|Morphine Prolonged-release (Part 1)|"10 milligram (mg) or 30 mg tablets were taken orally twice daily. Starting doses varied from 10 to 40 mg morphine PR twice daily depending on participant's weight; if necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 200 mg per day."
11194298|NCT02151682|FG001|Participant Flow|Tapentadol Prolonged-release (Part 1)|"25 mg or 100 mg tablets were taken orally twice daily. Starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11380756|NCT01231906|EG000|Reported Event|Arm A (Combination Chemotherapy)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9."
11240997|NCT02483676|BG001|Baseline|Treadmill Only|"This group will receive gait training on a treadmill, without use of the anklebot.~Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period"
11380757|NCT01231906|EG001|Reported Event|Arm B (Combination Chemotherapy, Topotecan Hydrochloride)|"INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.~CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19."
10784255|NCT00924326|OG007|Outcome|6.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
11240998|NCT02483676|BG002|Baseline|Total|Total of all reporting groups
11380758|NCT01470326|BG000|Baseline|Viviant (Bazedoxifene Acetate)|Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
11380759|NCT01470326|FG000|Participant Flow|Viviant (Bazedoxifene Acetate)|Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
11380760|NCT01470326|OG000|Outcome|Viviant (Bazedoxifene Acetate)|Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
11380761|NCT01470326|EG000|Reported Event|Viviant (Bazedoxifene Acetate)|Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
11380762|NCT01480180|BG000|Baseline|Prophylaxis|Participants received one single bolus dose of 50 U/kg of body weight (BW) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380763|NCT01480180|BG001|Baseline|On-demand|Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380764|NCT01480180|BG002|Baseline|Total|Total of all reporting groups
11380765|NCT01480180|FG000|Participant Flow|Prophylaxis|Participants received one single bolus dose of 50 U/kg of body weight (BW) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm is applicable only for the main phase.
11380766|NCT01480180|FG001|Participant Flow|On-demand|Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5. This arm is applicable only for the main phase.
11380767|NCT01480180|FG002|Participant Flow|N8-GP 50 U/kg Prophylaxis Q4D|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of >1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm was applicable for the extension phase part-1 and part 2.
11380768|NCT01480180|FG003|Participant Flow|N8-GP 75 U/kg Prophylaxis Q7D|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380769|NCT01480180|FG004|Participant Flow|N8-GP 20-75 U/kg On-demand|Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380770|NCT01480180|FG005|Participant Flow|N8-GP Prophylaxis|Participants in this arm include subjects both from the 50 U/kg Q4D and the 75 U/kg Q7D prophylaxis arms.
11380771|NCT01480180|OG000|Outcome|N8-GP 50 U/kg Prophylaxis Q4D|Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380772|NCT01480180|OG001|Outcome|N8-GP 20-75 U/kg On-demand|Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380773|NCT01480180|OG000|Outcome|N8-GP Prophylaxis|Participants from both the N8-GP 50 U/kg Q4D and N8-GP 75 U/kg Q7D groups were included in this arm.
11380774|NCT01480180|OG000|Outcome|N8-GP 50 U/kg Prophylaxis Q4D|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of >1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380775|NCT01480180|OG001|Outcome|N8-GP 75 U/kg Prophylaxis Q7D|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380776|NCT01480180|OG002|Outcome|N8-GP 20-75 U/kg On-demand|Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380777|NCT01480180|OG001|Outcome|N8-GP 20-75 U/kg On-demand|Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380778|NCT01480180|OG001|Outcome|N8-GP 20-75 U/kg On-demand|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380779|NCT01480180|OG001|Outcome|N8-GP 75 U/kg Prophylaxis Q7D|Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
11380780|NCT01480180|OG000|Outcome|N8-GP 50 U/kg Prophylaxis Q4D|Participants from the N8-GP 50 U/kg Q4D group were included in this arm.
11380781|NCT01480180|OG000|Outcome|N8-GP Prophylaxis|Participants from both the 50 U/kg Q4D and the 75 U/kg Q7D prophylaxis arms were included in this arm.
11380782|NCT01480180|OG001|Outcome|N8-GP 20-75 U/kg On-demand|Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5
11380783|NCT01480180|OG000|Outcome|N8-GP Prophylaxis|Participants in this arm included participants from both the Q4D and the Q7D groups
11380784|NCT01480180|OG000|Outcome|N8-GP 50 U/kg Prophylaxis Q4D:|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of >1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380785|NCT01480180|OG000|Outcome|N8-GP 50 U/kg Prophylaxis Q4D|Participants in this arm received one single bolus dose of 50 U/kg BW of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was adjusted to ensure a trough level of >1% FVIII:C activity in this arm.
11380786|NCT01480180|OG000|Outcome|Pharmacokinetics Assessment Arm|Patients participating in the pharmacokinetic assessments received a single i.v. bolus injection of 50 U/kg BW of N8-GP at Visit 2a (Week 0) and at Visit 7 (Week 28). The PK sessions were 4 days long and with multiple site visits. After completion of the PK sessions the patients continued treatment in the prophylaxis arm with the next visit in line. Patients must not have received current FVIII product for at least 4 days prior to the PK session at Visit 2a (Week 0) and N8-GP for at least 7 days prior to the PK session at Visit 7 (Week 28).
11380787|NCT01480180|EG000|Reported Event|N8-GP 50 U/kg Q4D Prophylaxis|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of >1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380788|NCT01480180|EG001|Reported Event|N8-GP 75 U/kg Q7D Prophylaxis|Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of >1% FVIII:C activity in the majority of participants in the prophylaxis arm.
11380789|NCT01480180|EG002|Reported Event|N8-GP 20-75 U/kg On-demand|Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
10784256|NCT00924326|OG008|Outcome|2.0x10^6 Cells/kg (Moderate Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
11194299|NCT02151682|FG002|Participant Flow|Tapentadol in Part 2 After Tapentadol or Morphine in Part 1|"26 Participants on tapentadol PR in Part 1 continued on the current dose of tapentadol PR in Part 2 and if necessary could modify their tapentadol PR dosage. 10 Participants on morphine PR in Part 1 were rotated to tapentadol PR in Part 2 with 70 percent of their current morphine equivalent dose or lower. The dosage could be increased gradually up to approximately 4.5 mg/kg body weight tapentadol PR twice daily.~Treatment with tapentadol was up to 12 months in Part 2."
11194300|NCT02151682|FG003|Participant Flow|Observation Period After Tapentadol in Part 1|"14 Participants who completed tapentadol PR in Part 1 of the study and 4 of 5 participants who discontinued tapentadol treatment early in Part 1 continued directly in the observation period in Part 2 for up to 12 months (with standard-of-care treatment if needed).~One subject who withdrew consent in Part 1 did not enter the observation period."
11380790|NCT01504438|BG000|Baseline|Salto-Talaris Total Ankle Replacement|Salto-Talaris Total Ankle Replacement surgery
11380791|NCT01504438|BG001|Baseline|STAR Total Ankle Replacement|STAR Total Ankle Replacement: STAR Total Ankle Replacement
11380792|NCT01504438|BG002|Baseline|Total|Total of all reporting groups
11380793|NCT01504438|FG000|Participant Flow|Salto-Talaris Total Ankle Replacement|Salto-Talaris Total Ankle Replacement surgery
11380794|NCT01504438|FG001|Participant Flow|STAR Total Ankle Replacement|STAR Total Ankle Replacement: STAR Total Ankle Replacement
11380795|NCT01504438|OG000|Outcome|Salto-Talaris Total Ankle Replacement|Salto-Talaris Total Ankle Replacement surgery
11380796|NCT01504438|OG001|Outcome|STAR|STAR Total Ankle Replacement
11380797|NCT01504438|OG001|Outcome|STAR Total Ankle Replacement|STAR Total Ankle Replacement: STAR Total Ankle Replacement
11380798|NCT01504438|EG000|Reported Event|Salto-Talaris Total Ankle Replacement|Salto-Talaris Total Ankle Replacement surgery
11380799|NCT01504438|EG001|Reported Event|STAR Total Ankle Replacement|STAR Total Ankle Replacement: STAR Total Ankle Replacement
11380800|NCT01545050|BG000|Baseline|Placebo|Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
11380801|NCT01545050|BG001|Baseline|Clazakizumab (150 IV/100 SC)|IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380802|NCT01545050|BG002|Baseline|Clazakizumab (300 IV/100 SC)|IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380803|NCT01545050|BG003|Baseline|Clazakizumab (400 SC/200 SC)|SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
11380804|NCT01545050|BG004|Baseline|Clazakizumab (600 IV/200 SC)|IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
11380805|NCT01545050|BG005|Baseline|Total|Total of all reporting groups
11380806|NCT01545050|FG000|Participant Flow|Placebo|Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
11380807|NCT01545050|FG001|Participant Flow|Clazakizumab (150 IV/100 SC)|IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380808|NCT01545050|FG002|Participant Flow|Clazakizumab (300 IV/100 SC)|IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380809|NCT01545050|FG003|Participant Flow|Clazakizumab (400 SC/200 SC)|SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
11380810|NCT01545050|FG004|Participant Flow|Clazakizumab (600 IV/200 SC)|IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
11380811|NCT01545050|OG000|Outcome|Placebo|Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
11380812|NCT01545050|OG001|Outcome|Clazakizumab (150 IV/100 SC)|IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380813|NCT01545050|OG002|Outcome|Clazakizumab (300 IV/100 SC)|IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380814|NCT01545050|OG003|Outcome|Clazakizumab (400 SC/200 SC)|SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
11380815|NCT01545050|OG004|Outcome|Clazakizumab (600 IV/200 SC)|IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
11380816|NCT01545050|OG000|Outcome|Clazakizumab (150 IV/100 SC)|IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380817|NCT01545050|OG001|Outcome|Clazakizumab (300 IV/100 SC)|IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380818|NCT01545050|OG002|Outcome|Clazakizumab (400 SC/200 SC)|SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
11380819|NCT01545050|OG003|Outcome|Clazakizumab (600 IV/200 SC)|IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
11380820|NCT01545050|EG000|Reported Event|Placebo|Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
11380821|NCT01545050|EG001|Reported Event|Clazakizumab (150 IV/100 SC)|IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380822|NCT01545050|EG002|Reported Event|Clazakizumab (300 IV/100 SC)|IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
11380823|NCT01545050|EG003|Reported Event|Clazakizumab (400 SC/200 SC)|SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
11380824|NCT01545050|EG004|Reported Event|Clazakizumab (600 IV/200 SC)|IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
11380825|NCT01550302|BG000|Baseline|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
11380826|NCT01550302|BG001|Baseline|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
11380827|NCT01550302|BG002|Baseline|Total|Total of all reporting groups
10784257|NCT00924326|OG009|Outcome|2.0x10^6 Cells/kg (9-12 Days Culture)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784258|NCT00924326|EG000|Reported Event|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784259|NCT00924326|EG001|Reported Event|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.~Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses."
10784260|NCT00924326|EG002|Reported Event|0.5x10^7 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784261|NCT00924326|EG003|Reported Event|2.5x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784262|NCT00924326|EG004|Reported Event|1.0x10^6 Cells/kg|"Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784263|NCT00924326|EG005|Reported Event|1.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784264|NCT00924326|EG006|Reported Event|2.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784265|NCT00924326|EG007|Reported Event|6.0x10^6 Cells/kg (Reduced Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784266|NCT00924326|EG008|Reported Event|2.0x10^6 Cells/kg (Moderate Chemo)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784267|NCT00924326|EG009|Reported Event|2.0x10^6 Cells/kg (9-12 Days Culture)|"Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes~Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes~Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
10784268|NCT00591318|BG000|Baseline|Ceftriaxone|Ceftriaxone Group (n=5)
10784269|NCT00591318|BG001|Baseline|Placebo|Placebo Group (n=5)
10784270|NCT00591318|BG002|Baseline|Total|Total of all reporting groups
10784271|NCT00591318|FG000|Participant Flow|IV Ceftriaxone|"IV Ceftriaxone 2 grams/day~ceftriaxone: 2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses"
10784272|NCT00591318|FG001|Participant Flow|IV Placebo|"IV Placebo (Normal Saline)~Normal Saline: 50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions."
10784273|NCT00591318|OG000|Outcome|Ceftriaxone Arm Results|This group was randomized to 2 gms of ceftriaxone given 5 days/week for 8 weeks. If participants were not at least 15% improved at 6 weeks, they were considered unlikely to respond and rated as having completed the randomized phase of treatment.
10784274|NCT00591318|OG001|Outcome|Placebo Arm Results|This group was randomized to receive saline given 5 days/week for 8 weeks
10784275|NCT00591318|OG000|Outcome|Ceftriaxone|Group randomized to Ceftriaxone
10784276|NCT00591318|OG001|Outcome|Placebo|This group received IV saline
10784277|NCT00591318|OG000|Outcome|Ceftriaxone|Sample randomized to IV Ceftriaxone
10784278|NCT00591318|OG001|Outcome|Placebo|Participants received IV saline
10784279|NCT00591318|EG000|Reported Event|Ceftriaxone|Participants randomized to Ceftriaxone
10784280|NCT00591318|EG001|Reported Event|Saline|Participants randomized to saline
10784281|NCT00321100|BG000|Baseline|Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle~Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle"
11194301|NCT02151682|FG004|Participant Flow|Observation Period After Morphine in Part 1|12 Participants who completed morphine PR treatment in Part 1 of the study and 2 participants who discontinued early from morphine treatment in Part 1 continued directly in the observation period in Part 2 (with standard-of-care treatment if needed).
11380828|NCT01550302|FG000|Participant Flow|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
11380829|NCT01550302|FG001|Participant Flow|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
11380830|NCT01550302|OG000|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
11380831|NCT01550302|OG001|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
11380832|NCT01550302|EG000|Reported Event|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
11380833|NCT01550302|EG001|Reported Event|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
10966616|NCT00887822|BG000|Baseline|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
11380834|NCT01555021|BG000|Baseline|Treatment as Usual|"Subjects in the Treatment as Usual group will proceed with treatment as usual, but have their blood samples for genotyping stored for future analysis.~Patients will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide saliva samples for GWAS analysis at a later date (note: GWAS analysis and genotyping for the Treatment as Usual group was not performed due to early termination of the study)~Patients will be asked to participate in 3 follow-up phone calls to measure their mood."
11380835|NCT01555021|BG001|Baseline|Assay Guided Treatment|"This group will receive a genotyping test to determine the specific levels of gene activity. This test was used to guide clinicians decision making for which antidepressants to prescribe and/or at what doses.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide saliva samples for GWAS analysis at a later date (note; GWAS analysis was not performed in the AGT group due to early termination of the study.~Subjects will be asked to participate in 3 follow-up phone calls to measure their mood."
11380836|NCT01555021|BG002|Baseline|Total|Total of all reporting groups
11380837|NCT01555021|FG000|Participant Flow|Treatment as Usual|"Subjects will provide blood samples prior to treatment, but will have their blood stored for later analysis.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva samples for GWAS analyses at a later date. However, the GWAS analyses were not performed due to the early termination of the study."
11380838|NCT01555021|FG001|Participant Flow|Assay Guided Treatment|"This test is used to guide clinicians in their recommendation antidepressant drugs based on CYP 450 gene activity for 1A2, 2C9, 2C19, 2D6, and 3A/4.~Subjects will be asked to provide blood samples. For subjects in the Assay-Guided Treatment group, their blood will be genotyped. Their psychiatrists will be given the results of the tests and then they will decide which antidepressants to use.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide saliva samples for GWAS analysis at a later date; however, GWAS analysis was not performed due to early termination of the study."
11380839|NCT01555021|OG000|Outcome|Treatment as Usual|"Subjects will be asked to provide blood samples for CYP 450 genotyping; however, the genotyping analysis will occur at a later date.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide a saliva sample for GWAS analysis at a later date. (note: genotyping analysis and GWAS analysis was not performed due to early termination of the study)"
11380840|NCT01555021|OG001|Outcome|Assay Guided Treatment|"This test is used to guide clinicians in their recommendations for antidepressant drugs based on CYP 450 gene activity for 1A2, 2C9, 2C19, 2D6, and 3A/4.~Subjects will be asked to provide a blood samples for CYP 450 genotyping. Subjects in the Assay-Guided Treatment group, will have their blood samples genotyped immediately. Their psychiatrists will be given the results of the tests within 3 to 5 days and then they will decide which antidepressants to use.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide a saliva sample for GWAS analysis at a later date. (note: GWAS analysis was not performed due to early termination of the study)"
11380841|NCT01555021|OG000|Outcome|Treatment as Usual|"Subjects will provide a blood sample for CYP-450 genotyping; however, the Treatment as Usual group will have their blood samples stored for analysis at a later date..~Patients will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva sample for GWAS analysis at a later date. (note: genotyping and GWAS analysis were not performed on any subjects due to early termination of the study)"
11380842|NCT01555021|OG001|Outcome|Assay Guided Treatment|"This test is used to guide clinicians in their recommendation antidepressant drugs based on CYP 450 gene activity for 1A2, 2C9, 2C19, 2D6, and 3A/4.~Subjects will be asked for a blood sample for CYP-450 genotyping. If the patient is in the Assay-Guided Treatment group, their blood will be genotyped immediately. Their psychiatrists will be given the results of the tests within 3 to 5 days and then they will decide whether to change their original first choice antidepressants.~Patients will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva sample for GWAS analysis at a later date. (note: GWAS analysis was not performed on any subjects due to early termination of the study)"
11380843|NCT01555021|OG000|Outcome|Treatment as Usual|"Subjects who are in the Treatment as Usual group will provide blood samples for genotyping, but their blood samples will be stored for analysis at a later date.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva sample for GWAS analysis at a later date. (note: genotyping for CYP 450 and GWAS analysis were not performed due to early termination of the study)."
11380844|NCT01555021|OG001|Outcome|Assay Guided Treatment (AGT)|"Subjects will provide a blood sample. Subjects in the AGT group will have their blood samples genotyped immediately. The treating psychiatrists will be given the results of the tests in 3 to 5 days and then they will decide whether to continue or change their first choice antidepressants. The genotyping test is a one-time occurrence that happens at the beginning of the study.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva sample for GWAS analyses at a later date. (note: GWAS analyses were not performed due to early termination of the study)."
11380845|NCT01555021|OG000|Outcome|Treatment as Usual|"This test is used to guide clinicians in their recommendation antidepressant drugs based on CYP 450 gene activity for 1A2, 2C9, 2C19, 2D6, and 3A/4.~Subjects in this group will be asked to provide blood samples for CYP genotyping at a later date. Their psychiatrists will decide which antidepressants to use as usual.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will be asked to provide saliva samples for GWAS analysis at a later date. (note: CYP genotyping and GWAS analysis for this group was not performed due to early termination of the study)."
11380846|NCT01555021|OG001|Outcome|Assay Guided Treatment|"This test is used to guide clinicians in their recommendation antidepressant drugs based on CYP 450 gene activity for 1A2, 2C9, 2C19, 2D6, and 3A/4.~Subjects will be asked to provide blood samples for CYP 450 genotyping.Their psychiatrists will be given the results of the tests within 3 to 5 days and then they will decide which antidepressants to use.~Subjects will receive questionnaires to measure their mood, side effects, and symptoms.~Subjects will provide a saliva sample for GWAS analysis at a later date. (note: GWAS analysis was not performed on any subjects due to early termination of the study)."
11240999|NCT02483676|FG000|Participant Flow|Treadmill+Anklebot|"This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.~Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period."
11380847|NCT01555021|EG000|Reported Event|Treatment as Usual (TAU)|"Patients in the TAU group provided blood samples to obtain genotyping to determine the specific activity of genes important in metabolizing antidepressants and to be processed at a later date; however, these blood samples were not analyzed due to the early termination of the study.~Patients received questionnaires to measure their mood, side effects, and symptoms.~Patients provided a saliva sample for GWAS analysis at a later date; however, GWAS analysis was not done due to the early termination of the study."
11380848|NCT01555021|EG001|Reported Event|Assay Guided Treatment (AGT)|"Patients in the AGT provided blood samples to obtain genotyping to determine the specific activities of genes important in metabolizing antidepressants. This test was used, at the beginning of treatment to guide clinicians in making recommendations as to which antidepressants and at what doses to prescribe.~Patients received questionnaires to measure their mood, side effects, and symptoms.~Patients in the AGT group provided saliva samples for GWAS analysis; however, GWAS analysis was not done due to the early termination of the study."
11380849|NCT01561430|BG000|Baseline|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
11380850|NCT01561430|BG001|Baseline|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
11380851|NCT01561430|BG002|Baseline|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
11380852|NCT01561430|BG003|Baseline|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
11380853|NCT01561430|BG004|Baseline|Total|Total of all reporting groups
11380854|NCT01561430|FG000|Participant Flow|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
11380855|NCT01561430|FG001|Participant Flow|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
11380856|NCT01561430|FG002|Participant Flow|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
11380857|NCT01561430|FG003|Participant Flow|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
11380858|NCT01561430|OG000|Outcome|15 mg LY2886721|LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
11380859|NCT01561430|OG001|Outcome|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
11380860|NCT01561430|OG002|Outcome|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
11380861|NCT01561430|OG003|Outcome|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
11380862|NCT01561430|OG002|Outcome|70 mg LY2886721|70 mg, capsules, administered orally, once daily for 26 weeks.
11380863|NCT01561430|EG000|Reported Event|15 mg LY2886721|LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks.
11380864|NCT01561430|EG001|Reported Event|35 mg LY2886721|LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
11380865|NCT01561430|EG002|Reported Event|70 mg LY2886721|LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
11380866|NCT01561430|EG003|Reported Event|Placebo|Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
11380867|NCT01580813|BG000|Baseline|All Participants|"Acipimox, then Placebo Subjects will take acipimox 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by Placebo pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit~Placebo, then Acipimox Subjects will take a placebo pill 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by acipimox pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit"
11380868|NCT01580813|FG000|Participant Flow|Acipimox, Then Placebo|Subjects will take acipimox 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by Placebo pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit
11380869|NCT01580813|FG001|Participant Flow|Placebo, Then Acipimox|Subjects will take a placebo pill 250mg (random order crossover and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit, followed by acipimox pill 250 mg by mouth four times a day for six days prior to the visit and one dose the morning of study visit
11380870|NCT01580813|OG000|Outcome|Acipimox|"Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi~Acipimox: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit."
10784282|NCT00321100|BG001|Baseline|Cetuximab, Oxaliplatin, Capecitabine|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle"
11380871|NCT01580813|OG001|Outcome|Placebo|"Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit~Placebo: Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit."
11380872|NCT01580813|EG000|Reported Event|Acipimox|"Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi~Acipimox: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit."
11380873|NCT01580813|EG001|Reported Event|Placebo|"Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit~Placebo: Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit."
11380874|NCT01595009|BG000|Baseline|pNET (Core)|Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380875|NCT01595009|BG001|Baseline|Non-pNET (Core)|Participants with NETs of a GI or lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380876|NCT01595009|BG002|Baseline|Total|Total of all reporting groups
11380877|NCT01595009|FG000|Participant Flow|pNET (Core)|Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380878|NCT01595009|FG001|Participant Flow|Non-pNET (Core)|Participants with NETs of a GI or lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380879|NCT01595009|FG002|Participant Flow|Lung NET (E1)|Participants with NETs of a lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380880|NCT01595009|FG003|Participant Flow|GI NET (E1)|Participants with NETs of a GI origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380881|NCT01595009|OG000|Outcome|pNET (Core)|Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380882|NCT01595009|OG001|Outcome|Non-pNET (Core)|Participants with NETs of a GI or lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380883|NCT01595009|OG000|Outcome|Lung NET (E1)|Participants with NETs of a lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380884|NCT01595009|OG001|Outcome|GI NET|Participants with NETs of a GI origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380885|NCT01595009|OG000|Outcome|pNET (Core)|Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380886|NCT01595009|OG001|Outcome|Non-pNET (Core)|Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380887|NCT01595009|OG000|Outcome|Lung NET (E1)|Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380888|NCT01595009|OG001|Outcome|GI NET (E1)|Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380889|NCT01595009|OG001|Outcome|GI NET|Participants received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
11380890|NCT01595009|EG000|Reported Event|pNET (Core)|pNET (Core)
11380891|NCT01595009|EG001|Reported Event|Non-pNET (Core)|Non-pNET (Core)
11380892|NCT01595009|EG002|Reported Event|Lung NET (E1)|Lung NET (E1)
11380893|NCT01595009|EG003|Reported Event|GI NET (E1)|GI NET (E1)
10784283|NCT00321100|BG002|Baseline|Total|Total of all reporting groups
10784284|NCT00321100|FG000|Participant Flow|Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle~Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle"
10784285|NCT00321100|FG001|Participant Flow|Cetuximab, Oxaliplatin, Capecitabine|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle"
10784286|NCT00321100|OG000|Outcome|Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle~Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle"
10784287|NCT00321100|OG001|Outcome|Cetuximab, Oxaliplatin, Capecitabine|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle"
10784288|NCT00321100|EG000|Reported Event|Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle~Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle"
10784289|NCT00321100|EG001|Reported Event|Cetuximab, Oxaliplatin, Capecitabine|"Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle~Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle~Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle"
10801878|NCT03079102|BG000|Baseline|Inhaled Nitric Oxide (iNO)|"20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.~Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation."
10964638|NCT00878553|OG002|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11380894|NCT01613807|BG000|Baseline|Mix 50/50|"3 doses of Mix 50/50 at mealtime~Insulin LISPRO : Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history."
11380895|NCT01613807|BG001|Baseline|Usual Insulin Regimen|"3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime~Insulin, Long-Acting and Insulin LISPRO : Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal."
10801879|NCT03079102|BG001|Baseline|Placebo|"Nitrogen carrier gas delivered by identical system with similar dose/taper.~Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen."
10801880|NCT03079102|BG002|Baseline|Total|Total of all reporting groups
10801881|NCT03079102|FG000|Participant Flow|Inhaled Nitric Oxide (iNO)|"20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.~Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation."
10801882|NCT03079102|FG001|Participant Flow|Placebo|"Nitrogen carrier gas delivered by identical system with similar dose/taper.~Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen."
10801883|NCT03079102|OG000|Outcome|Inhaled Nitric Oxide (iNO)|"20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.~Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation."
10801884|NCT03079102|OG001|Outcome|Placebo|"Nitrogen carrier gas delivered by identical system with similar dose/taper.~Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen."
10801885|NCT03079102|EG000|Reported Event|Inhaled Nitric Oxide (iNO)|"20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.~Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation."
10801886|NCT03079102|EG001|Reported Event|Placebo|"Nitrogen carrier gas delivered by identical system with similar dose/taper.~Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen."
10801887|NCT02944513|BG000|Baseline|Experimental|"Subjects will receive the Quell device~Quell"
10801888|NCT02944513|BG001|Baseline|Control|Subjects will not receive the Quell device
10801889|NCT02944513|BG002|Baseline|Total|Total of all reporting groups
10801890|NCT02944513|FG000|Participant Flow|Experimental|Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.
10801891|NCT02944513|FG001|Participant Flow|Control|Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
10801892|NCT02944513|OG000|Outcome|Experimental|Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.
11194302|NCT02151682|FG005|Participant Flow|Observation Period After Tapentadol in Part 2|19 Participants who completed tapentadol treatment in Part 1 and discontinued from tapentadol treatment in Part 2 and 7 participants who completed morphine treatment in Part 1 and discontinued from tapentadol in Part 2 entered the Observation Period for up to 12 months (with standard-of-care treatment if needed).
11380896|NCT01613807|BG002|Baseline|Total|Total of all reporting groups
11380897|NCT01613807|FG000|Participant Flow|Mix 50/50|"Premixed Mix 50/50 at mealtime, three times per day~Humalog® Mix50/50™ [50% insulin lispro protamine suspension mixed with 50% insulin lispro injection, (rDNA origin)], given subcutaneously three times daily at mealtime, for a maximum of THREE total insulin injections per day. Dose determined by blood glucose history."
11380898|NCT01613807|FG001|Participant Flow|Control Group: Usual Insulin Regmien|"Multiple daily injections:~3 injections of Humalog(r) daily with meals; AND 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime~Long-Acting and Rapid-acting insulin administered as SIX separate injections. Long-acting NPH insulin was given three times daily on rising, mid-afternoon, and before bed, and insulin lispro was administered three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal."
11380899|NCT01613807|OG000|Outcome|Mix 50/50|"3 doses of Mix 50/50 at mealtime~Insulin LISPRO : Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history."
11380900|NCT01613807|OG001|Outcome|Usual Insulin Regimen|"3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime~Insulin, Long-Acting and Insulin LISPRO : Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal."
11380901|NCT01613807|OG000|Outcome|Mix 50/50|"Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.~Insulin LISPRO: Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history."
11380902|NCT01613807|OG001|Outcome|Usual Insulin Regimen|"Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime~Insulin, Long-Acting and Insulin: Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal."
11380903|NCT01613807|EG000|Reported Event|Mix 50/50|"3 doses of Mix 50/50 at mealtime~Insulin LISPRO : Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history."
11380904|NCT01613807|EG001|Reported Event|Usual Insulin Regimen|"3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime~Insulin, Long-Acting and Insulin LISPRO : Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal."
10784290|NCT04534517|BG000|Baseline|Hyperopes|All subjects dispensed a study lens.
10784291|NCT04534517|BG001|Baseline|Myopes|All subjects dispensed a study lens.
11380905|NCT01620944|BG000|Baseline|Arm A|Reference Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Tenofovir/emtricitabine [TDF/FTC] 300/200 mg QD by mouth for 48 weeks
11380906|NCT01620944|BG001|Baseline|Arm B|Experimental Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Lamivudine [3TC] 300 mg QD by mouth for 48 weeks
11380907|NCT01620944|BG002|Baseline|Total|Total of all reporting groups
11380908|NCT01620944|FG000|Participant Flow|Arm A|Reference Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Tenofovir/emtricitabine [TDF/FTC] 300/200 mg QD by mouth for 48 weeks
11380909|NCT01620944|FG001|Participant Flow|Arm B|Experimental Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Lamivudine [3TC] 300 mg QD by mouth for 48 weeks
11380910|NCT01620944|OG000|Outcome|Arm A|Reference Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Tenofovir/emtricitabine [TDF/FTC] 300/200 mg QD by mouth for 48 weeks
11380911|NCT01620944|OG001|Outcome|Arm B|Experimental Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Lamivudine [3TC] 300 mg QD by mouth for 48 weeks
11380912|NCT01620944|EG000|Reported Event|Arm A|Reference Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Tenofovir/emtricitabine [TDF/FTC] 300/200 mg QD by mouth for 48 weeks
11380913|NCT01620944|EG001|Reported Event|Arm B|Experimental Therapy: Atazanavir, heat-stable ritonavir [ATV/RTVHS] 300/100 mg QD + Lamivudine [3TC] 300 mg QD by mouth for 48 weeks
11380914|NCT01627561|BG000|Baseline|Cervarix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380915|NCT01627561|BG001|Baseline|Priorix + Infanrix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380916|NCT01627561|BG002|Baseline|Total|Total of all reporting groups
11380917|NCT01627561|FG000|Participant Flow|Cervarix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380918|NCT01627561|FG001|Participant Flow|Priorix + Infanrix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380919|NCT01627561|OG000|Outcome|Cervarix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380920|NCT01627561|OG001|Outcome|Priorix + Infanrix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380921|NCT01627561|EG000|Reported Event|Cervarix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380922|NCT01627561|EG001|Reported Event|Priorix + Infanrix Group|Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
11380940|NCT01652534|BG000|Baseline|Amantadine Crossover to Placebo|"For first 4 weeks of study Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day~Amantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).~Crossover to Placebo (sugar pill) at week 7"
11380941|NCT01652534|BG001|Baseline|Placebo Crossover to Amantadine|"For first 4 weeks of study, Placebo (sugar pill)~Crossover to Amantadine at week 7 Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day~Amantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN)."
11380942|NCT01652534|BG002|Baseline|Total|Total of all reporting groups
11380943|NCT01652534|FG000|Participant Flow|Amantadine, Then Placebo|Participants first received Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week. After a washout period of 3 weeks, they then placebo tablet (matching Amantadine 100mg tablet) orally for 4 weeks.
11380944|NCT01652534|FG001|Participant Flow|Placebo, Then Amantadine|Participants first received Placebo tablet (matching Amantadine 100 mg tablet) orally once a day for one week, then Amantadine placebo two tablets orally twice a day for one week. After a washout period of 4 weeks, then they received Amantadine 100mg tablet orally for 4 weeks.
11380945|NCT01652534|OG000|Outcome|Amantadine|"Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day~Amantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN)."
11380946|NCT01652534|OG001|Outcome|Placebo|"Sugar Pill~Placebo: Sugar Pill"
11380947|NCT01652534|EG000|Reported Event|Amantadine|Participants during Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week.
11380948|NCT01652534|EG001|Reported Event|Placebo|Participants during Placebo tablet (matching Amantadine 100 mg tablet)
10784292|NCT04534517|BG002|Baseline|Total|Total of all reporting groups
10784293|NCT04534517|FG000|Participant Flow|Senofilcon A (Investigational Multifocal Lens)|All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
10784294|NCT04534517|OG000|Outcome|Senofilcon A (Investigational Multifocal Lens)|All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
10784295|NCT04534517|EG000|Reported Event|Senofilcon A (Investigational Multifocal Lens)|All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
10784296|NCT04494646|BG000|Baseline|Bardoxolone Methyl|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)"
10784297|NCT04494646|BG001|Baseline|Placebo|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Placebo: Once-daily administration of matching placebo"
10784298|NCT04494646|BG002|Baseline|Total|Total of all reporting groups
10784299|NCT04494646|FG000|Participant Flow|Bardoxolone Methyl|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)"
10784300|NCT04494646|FG001|Participant Flow|Placebo|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Placebo: Once-daily administration of matching placebo"
10784301|NCT04494646|OG000|Outcome|Bardoxolone Methyl|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)"
10784302|NCT04494646|OG001|Outcome|Placebo|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Placebo: Once-daily administration of matching placebo"
10784303|NCT04494646|EG000|Reported Event|Bardoxolone Methyl|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)"
10784304|NCT04494646|EG001|Reported Event|Placebo|"Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo~Placebo: Once-daily administration of matching placebo"
10784305|NCT04258020|BG000|Baseline|Experimental: Alternating BiPAP and HFNC|"Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation~BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration~HFNC: Heated High Flow Nasal Cannula oxygen administration"
10784306|NCT04258020|BG001|Baseline|Historical Control: Standard of Care|A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
10784307|NCT04258020|BG002|Baseline|Total|Total of all reporting groups
10784308|NCT04258020|FG000|Participant Flow|Experimental: Alternating BiPAP and HFNC|"Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation~BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration~HFNC: Heated High Flow Nasal Cannula oxygen administration"
10784309|NCT04258020|FG001|Participant Flow|Historical Control: Standard of Care|A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
10784310|NCT04258020|OG000|Outcome|Experimental: Alternating BiPAP and HFNC|"Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation~BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration~HFNC: Heated High Flow Nasal Cannula oxygen administration"
10784311|NCT04258020|OG001|Outcome|Historical Control: Standard of Care|A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
11241000|NCT02483676|FG001|Participant Flow|Treadmill Only|"This group will receive gait training on a treadmill, without use of the anklebot.~Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period"
10784312|NCT04258020|EG000|Reported Event|Experimental: Alternating BiPAP and HFNC|"Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation~BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration~HFNC: Heated High Flow Nasal Cannula oxygen administration"
10784313|NCT04258020|EG001|Reported Event|Historical Control: Standard of Care|A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
10784314|NCT04234464|BG000|Baseline|A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI|"Subjects randomized to receive single dose of BDA MDI (PT027) at Visit 3/Period 1, and a single dose of placebo MDI at Visit 4/Period 2.~Visit 3/Period 1 (Day 1) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose~Visit 4/Period 2 (Day 8 +/- 6 days) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose"
10784315|NCT04234464|BG001|Baseline|B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180|"Subjects randomized to receive single dose of placebo MDI at Visit 3/Period 1, and a single dose of BDA MDI (PT027) at Visit 4/Period 2.~Visit 3/Period 1 (Day 1) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose~Visit 4/Period 2 (Day 8 +/- 6 days) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose"
10784316|NCT04234464|BG002|Baseline|Total|Total of all reporting groups
10784317|NCT04234464|FG000|Participant Flow|A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI|"Subjects randomized to receive a single dose of BDA MDI (PT027) at Visit 3/Period 1, and a single dose of placebo MDI at Visit 4/Period 2.~Visit 3/Period 1 (Day 1) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose.~Visit 4/Period 2 (Day 8 +/- 6 days) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose."
10801893|NCT02944513|OG001|Outcome|Control|Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
10801894|NCT02944513|EG000|Reported Event|Experimental|Subjects will receive the Quell device at the baseline visit and will be asked to use the device every day for 3 months.
11194303|NCT02151682|OG000|Outcome|Morphine Prolonged-release (Part 1)|"The treatment group comprised 7 participants aged 6 years to less than 12 years and 17 participants aged 12 years to less than 18 years. Starting doses varied from 10 to 40 milligrams (mg) morphine PR twice daily depending on participant's weight; if necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 200 mg per day."
11241001|NCT02483676|OG000|Outcome|Treadmill+Anklebot|"This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.~Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period."
11380923|NCT01629511|BG000|Baseline|Gemcitabine Dose Level 1|Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380924|NCT01629511|BG001|Baseline|Gemcitabine Dose Level 2|Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380925|NCT01629511|BG002|Baseline|Gemcitabine Dose Level 3|Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380926|NCT01629511|BG003|Baseline|Gemcitabine Dose Level 4|Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380927|NCT01629511|BG004|Baseline|Total|Total of all reporting groups
11380928|NCT01629511|FG000|Participant Flow|Gemcitabine Dose Level 1|Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380929|NCT01629511|FG001|Participant Flow|Gemcitabine Dose Level 2|Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380930|NCT01629511|FG002|Participant Flow|Gemcitabine Dose Level 3|Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380931|NCT01629511|FG003|Participant Flow|Gemcitabine Dose Level 4|Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380932|NCT01629511|OG000|Outcome|Gemcitabine Dose Level 1|Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380933|NCT01629511|OG001|Outcome|Gemcitabine Dose Level 2|Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380934|NCT01629511|OG002|Outcome|Gemcitabine Dose Level 3|Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380935|NCT01629511|OG003|Outcome|Gemcitabine Dose Level 4|Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380936|NCT01629511|EG000|Reported Event|Gemcitabine Dose Level 1|Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380937|NCT01629511|EG001|Reported Event|Gemcitabine Dose Level 2|Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380938|NCT01629511|EG002|Reported Event|Gemcitabine Dose Level 3|Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380939|NCT01629511|EG003|Reported Event|Gemcitabine Dose Level 4|Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
11380949|NCT01670565|BG000|Baseline|Mycophenolate Mofetil + Belimumab|"All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After the patient has been titrated to 2 grams of MMF per day, the patient will receive EITHER a 10 mg/kg belimumab (Benlysta) intravenous infusion OR placebo (saline) infusion. This medication and infusion will be covered by the study.~Belimumab: Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic sclerosis."
11194304|NCT02151682|OG001|Outcome|Tapentadol Prolonged-release (Part 1)|"The treatment group comprised 12 participants aged 6 years to less than 12 years and 33 participants aged 12 years to less than 18 years. Participants starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11380950|NCT01670565|BG001|Baseline|Mycophenolate Mofetil + Saline (Placebo)|In order to observe the difference between belimumab/MMF compared to MMF alone, half of the patients will receive a normal saline infusion that appears identical to the belimumab infusion.
11380951|NCT01670565|BG002|Baseline|Total|Total of all reporting groups
11380952|NCT01670565|FG000|Participant Flow|Mycophenolate Mofetil + Belimumab|"Patients in this arm will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice titrated to 2 grams of MMF per day, followed by 10 mg/kg belimumab (Benlysta). Belimumab Infusion will be administered 14 times over a period of 48 weeks. MMF will be administered through 48 weeks.~Belimumab: Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic sclerosis."
11380953|NCT01670565|FG001|Participant Flow|Mycophenolate Mofetil + Saline (Placebo)|Patients in this arm will FIRST receive MMF alone followed by normal saline infusion that appears identical to the belimumab infusion. Saline Infusion will be administered 14 times over a period of 48 weeks. MMF will be administered through 48 weeks.
11380954|NCT01670565|OG000|Outcome|Mycophenolate Mofetil + Belimumab|"All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, patients in this experimental group will receive a 10 mg/kg belimumab (Benlysta) intravenous infusion infusion.This medication and infusion will of course be covered by the study.~Belimumab: Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic"
11380955|NCT01670565|OG001|Outcome|Mycophenolate Mofetil + Saline (Placebo)|"In order to observe the difference between belimumab/MMF compared to MMF alone, half of the patients will receive a normal saline infusion that appears identical to the belimumab infusion.~All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, patients in this experimental group will receive a placebo (saline) infusion.This infusion will of course be covered by the study.~."
11380956|NCT01670565|OG001|Outcome|Mycophenolate Mofetil + Saline (Placebo)|"In order to observe the difference between belimumab/MMF compared to MMF alone, half of the patients will receive a normal saline infusion that appears identical to the belimumab infusion.~All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, patients in this experimental group will receive a placebo (saline) infusion.This infusion will of course be covered by the study."
11380957|NCT01670565|OG000|Outcome|Mycophenolate Mofetil + Belimumab|"All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, the patient will receive a 10 mg/kg belimumab (Benlysta) intravenous infusion.This medication and infusion will of course be covered by the study.~Belimumab: Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic"
11380958|NCT01670565|EG000|Reported Event|Mycophenolate Mofetil + Belimumab|"All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, the patient will receive a 10 mg/kg belimumab (Benlysta) intravenous infusion. This medication and infusion will be covered by the study.~Belimumab: Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic sclerosis."
11380959|NCT01670565|EG001|Reported Event|Mycophenolate Mofetil + Saline (Placebo)|"In order to observe the difference between belimumab/MMF compared to MMF alone, half of the patients will receive a normal saline infusion that appears identical to the belimumab infusion.~All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After being titrated to 2 grams of MMF per day, patients in this experimental group will receive a placebo (saline) infusion.This infusion will of course be covered by the study."
11380960|NCT04871425|BG000|Baseline|Fentanyl|"Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV fentanyl over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.~Fentanyl: IV fentanyl"
11380961|NCT04871425|BG001|Baseline|Ketamine|"Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV ketamine over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.~Ketamine: IV ketamine"
11380962|NCT04871425|BG002|Baseline|Total|Total of all reporting groups
11380963|NCT04871425|FG000|Participant Flow|Ketamine|"Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.~Ketamine: IV ketamine"
11380964|NCT04871425|FG001|Participant Flow|Fentanyl|"Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.~Fentanyl: IV fentanyl"
11380965|NCT04871425|OG000|Outcome|Ketamine|"Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.~Ketamine: IV ketamine"
11380966|NCT04871425|OG001|Outcome|Fentanyl|"Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.~Fentanyl: IV fentanyl"
11380967|NCT04871425|EG000|Reported Event|Ketamine|"Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.~Ketamine: IV ketamine"
11380968|NCT04871425|EG001|Reported Event|Fentanyl|"Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.~Fentanyl: IV fentanyl"
11380969|NCT04799405|BG000|Baseline|tDCS MDD|"A group of 5 participants with major depressive disorder (MDD).~tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.~tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:~First taper phase: three 30 minutes tDCS sessions applied every other day;~Second taper phase: three 30 minutes tDCS sessions applied one every third day;~Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day."
11380970|NCT04799405|FG000|Participant Flow|tDCS MDD|"A group of participants with major depressive disorder (MDD).~tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.~tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:~First taper phase: three 30 minutes tDCS sessions applied every other day;~Second taper phase: three 30 minutes tDCS sessions applied one every third day;~Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day."
11241002|NCT02483676|OG001|Outcome|Treadmill Only|"This group will receive gait training on a treadmill, without use of the anklebot.~Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period"
11380971|NCT04799405|OG000|Outcome|tDCS MDD|"A group of participants with major depressive disorder (MDD).~tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.~tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:~First taper phase: three 30 minutes tDCS sessions applied every other day;~Second taper phase: three 30 minutes tDCS sessions applied one every third day;~Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day."
11380972|NCT04799405|EG000|Reported Event|tDCS MDD|"A group of participants with major depressive disorder (MDD).~tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.~tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:~First taper phase: three 30 minutes tDCS sessions applied every other day;~Second taper phase: three 30 minutes tDCS sessions applied one every third day;~Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day."
11380973|NCT04748458|BG000|Baseline|Congenital Hip Pathologies|"Conical tapered stem for osteoarthritis due to congenital hip pathologies~Conical tapered stem: Implantation of conical tapered stem"
11380974|NCT04748458|FG000|Participant Flow|Congenital Hip Pathologies|"Conical tapered stem for osteoarthritis due to congenital hip pathologies~Conical tapered stem: Implantation of conical tapered stem"
11380975|NCT04748458|OG000|Outcome|Congenital Hip Pathologies|"Conical tapered stem for osteoarthritis due to congenital hip pathologies~Conical tapered stem: Implantation of conical tapered stem"
11380976|NCT04748458|EG000|Reported Event|Congenital Hip Pathologies|"Conical tapered stem for osteoarthritis due to congenital hip pathologies~Conical tapered stem: Implantation of conical tapered stem"
11380977|NCT04537949|BG000|Baseline|Part A Participants Aged 18 to 55 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380978|NCT04537949|BG001|Baseline|Part A Participants Aged 18 to 55 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380979|NCT04537949|BG002|Baseline|Part A Participants Aged 18 to 55 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380980|NCT04537949|BG003|Baseline|Part A Participants Aged 18 to 55 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
11380981|NCT04537949|BG004|Baseline|Part A Participants Aged 56 to 85 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380982|NCT04537949|BG005|Baseline|Part A Participants Aged 56 to 85 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380983|NCT04537949|BG006|Baseline|Part A Participants Aged 56 to 85 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380984|NCT04537949|BG007|Baseline|Part A Participants Aged 56 to 85 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380985|NCT04537949|BG008|Baseline|Total|Total of all reporting groups
11380986|NCT04537949|FG000|Participant Flow|Part A Participants Aged 18 to 55 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380987|NCT04537949|FG001|Participant Flow|Part A Participants Aged 18 to 55 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380988|NCT04537949|FG002|Participant Flow|Part A Participants Aged 18 to 55 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380989|NCT04537949|FG003|Participant Flow|Part A Participants Aged 18 to 55 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).
11380990|NCT04537949|FG004|Participant Flow|Part A Participants Aged 56 to 85 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380991|NCT04537949|FG005|Participant Flow|Part A Participants Aged 56 to 85 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380992|NCT04537949|FG006|Participant Flow|Part A Participants Aged 56 to 85 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380993|NCT04537949|FG007|Participant Flow|Part A Participants Aged 56 to 85 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380994|NCT04537949|OG000|Outcome|Part A Participants Aged 18 to 55 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
10801895|NCT02944513|EG001|Reported Event|Control|Subjects will not receive the Quell device at the baseline visit, but they will receive one after 3 months.
11380995|NCT04537949|OG001|Outcome|Part A Participants Aged 18 to 55 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380996|NCT04537949|OG002|Outcome|Part A Participants Aged 18 to 55 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380997|NCT04537949|OG003|Outcome|Part A Participants Aged 18 to 55 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
11380998|NCT04537949|OG004|Outcome|Part A Participants Aged 56 to 85 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11380999|NCT04537949|OG005|Outcome|Part A Participants Aged 56 to 85 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381000|NCT04537949|OG006|Outcome|Part A Participants Aged 56 to 85 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381001|NCT04537949|OG007|Outcome|Part A Participants Aged 56 to 85 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381002|NCT04537949|EG000|Reported Event|Part A Participants Aged 18 to 55 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381003|NCT04537949|EG001|Reported Event|Part A Participants Aged 18 to 55 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381004|NCT04537949|EG002|Reported Event|Part A Participants Aged 18 to 55 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381005|NCT04537949|EG003|Reported Event|Part A Participants Aged 18 to 55 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
11381006|NCT04537949|EG004|Reported Event|Part A Participants Aged 56 to 85 Years - 3 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11194305|NCT02151682|OG002|Outcome|Tapentadol Prolonged-release (Part 2)|"36 Participants who completed Part 1 of the trial (26 on tapentadol PR and 10 participants on morphine PR) continued treatment or switched to treatment with tapentadol PR for up to 12 months in Part 2.~Participants on tapentadol PR in Part 1 continued on the current dose of tapentadol PR in Part 2 and if necessary could modify their tapentadol PR dosage. Participants on morphine PR in Part 1 were rotated to tapentadol PR in Part 2 with 70 percent of their current morphine equivalent dose or lower. The dosage could be increased gradually up to approximately 4.5 mg/kg body weight tapentadol PR twice daily."
11194306|NCT02151682|OG000|Outcome|Tapentadol Prolonged-release (Part 2)|"36 participants who completed Part 1 of the trial (26 on tapentadol PR and 10 participants on morphine PR) continued treatment or switched to treatment with tapentadol PR for up to 12 months in Part 2.~Participants on tapentadol PR in Part 1 continued on the current dose of tapentadol PR in Part 2 and if necessary could modify their tapentadol PR dosage. Participants on morphine PR in Part 1 were rotated to tapentadol PR in Part 2 with 70 percent of their current morphine equivalent dose or lower. The dosage could be increased gradually up to approximately 4.5 mg/kg body weight tapentadol PR twice daily."
11381007|NCT04537949|EG005|Reported Event|Part A Participants Aged 56 to 85 Years - 10 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381008|NCT04537949|EG006|Reported Event|Part A Participants Aged 56 to 85 Years - 20 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381009|NCT04537949|EG007|Reported Event|Part A Participants Aged 56 to 85 Years - 30 μg|BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
11381010|NCT04529499|BG000|Baseline|Favipiravir + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio"
11381011|NCT04529499|BG001|Baseline|Placebo + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio"
11381012|NCT04529499|BG002|Baseline|Total|Total of all reporting groups
11381013|NCT04529499|FG000|Participant Flow|Favipiravir + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio"
11381014|NCT04529499|FG001|Participant Flow|Placebo + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio"
11381015|NCT04529499|OG000|Outcome|Favipiravir + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio"
11381016|NCT04529499|OG001|Outcome|Placebo + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio"
11381017|NCT04529499|EG000|Reported Event|Favipiravir + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio"
11381018|NCT04529499|EG001|Reported Event|Placebo + Supportive Care|"Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.~Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio"
11381019|NCT04501094|BG000|Baseline|Cohort 1B - Checkpoint Inhibitor Naïve Participants Who Are Refractory Post-platinum Therapy|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381020|NCT04501094|BG001|Baseline|Cohort 2B - Checkpoint Inhibitor Refractory Participants With Stable Disease or Progressive Disease|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381021|NCT04501094|BG002|Baseline|Total|Total of all reporting groups
11381022|NCT04501094|FG000|Participant Flow|Cohort 1B - Checkpoint Inhibitor Naïve Participants Who Are Refractory Post-platinum Therapy|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381023|NCT04501094|FG001|Participant Flow|Cohort 2B - Checkpoint Inhibitor Refractory Participants With Stable Disease or Progressive Disease|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381024|NCT04501094|OG000|Outcome|Cohort 1B - Checkpoint Inhibitor Naïve Participants Who Are Refractory Post-platinum Therapy|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381025|NCT04501094|OG001|Outcome|Cohort 2B - Checkpoint Inhibitor Refractory Participants With Stable Disease or Progressive Disease|Treatment with Bintrafusp alfa (M7824) Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks
10784318|NCT04234464|FG001|Participant Flow|B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180|"Subjects randomized to receive a single dose of placebo MDI at Visit 3/Period 1, and a single dose of BDA MDI (PT027) at Visit 4/Period 2.~Visit 3/Period 1 (Day 1) - Placebo metered-dose inhaler: Placebo inhalation aerosol single dose.~Visit 4/Period 2 (Day 8 +/- 6 days) - Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol single dose."
10784319|NCT04234464|OG000|Outcome|Treatment Intervention A - BDA MDI 160/180 - All Subjects|Analysis of subjects receiving Treatment Intervention A - BDA MDI 160/180
10784320|NCT04234464|OG001|Outcome|Treatment Intervention B - Placebo MDI - All Subjects|Analysis of subjects receiving Treatment Intervention B - Placebo MDI
10784321|NCT04234464|EG000|Reported Event|Treatment Intervention - BDA MDI 160/180 - All Subjects|Safety analysis of subjects receiving Treatment A - BDA MDI 160/180
10784322|NCT04234464|EG001|Reported Event|Treatment Intervention - Placebo MDI - All Subjects|Safety analysis of subjects receiving Treatment B - Placebo MDI
10784323|NCT03852316|BG000|Baseline|Click Device|Female participants >=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
10784324|NCT03852316|FG000|Participant Flow|Click Device|Female participants >=14 years of age who may have been symptomatic or asymptomatic for sexually transmitted infections (STIs). Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
10784325|NCT03852316|OG000|Outcome|Click Device|Female participants >=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
10784326|NCT03852316|EG000|Reported Event|Click Device|Female participants >=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
10784327|NCT03789318|BG000|Baseline|CA-008 5 mg (0.05 mg/mL) Cohort 1|"Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~CA-008 5 mg: 5 mg CA-008~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784328|NCT03789318|BG001|Baseline|Placebo for Cohort 1|"Cohort 1:~Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784329|NCT03789318|BG002|Baseline|CA-008 10 mg (0.1 mg/mL)|"Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 10 mg: 10 mg CA-008"
11194307|NCT02151682|OG000|Outcome|Tapentadol Prolonged-release (All Participants)|"The treatment group comprised 12 participants aged 6 years to less than 12 years and 33 participants aged 12 years to less than 18 years. Participants starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
10784330|NCT03789318|BG003|Baseline|CA-008 15 mg (0.15 mg/mL)|"Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 15 mg: 15 mg CA-008"
10784331|NCT03789318|BG004|Baseline|Placebo for Cohorts 2 and 3|"Cohorts 2 & 3:~Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784332|NCT03789318|BG005|Baseline|Total|Total of all reporting groups
10850633|NCT00303667|EG001|Reported Event|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
10784333|NCT03789318|FG000|Participant Flow|CA-008 5 mg (0.05 mg/mL) Cohort 1|"Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~CA-008 5 mg: 5 mg CA-008 reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784334|NCT03789318|FG001|Participant Flow|Placebo for Cohort 1|"Cohort 1: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784335|NCT03789318|FG002|Participant Flow|CA-008 10 mg (0.1 mg/mL) Cohort 2|"Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 10 mg: 10 mg CA-008 reconstituted in saline."
11381026|NCT04501094|EG000|Reported Event|Cohort 1B - Checkpoint Inhibitor Naïve Participants Who Are Refractory Post-platinum Therapy|"Treatment with Bintrafusp alfa (M7824)~Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks"
11381027|NCT04501094|EG001|Reported Event|Cohort 2B - Checkpoint Inhibitor Refractory Participants With Stable Disease or Progressive Disease|Treatment with Bintrafusp alfa (M7824) Bintrafusp alfa (M7824): 1200 mg administered intravenous (IV) every two weeks
10784336|NCT03789318|FG003|Participant Flow|CA-008 15 mg (0.15 mg/mL) Cohort 3|"Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 15 mg: 15 mg CA-008 reconstituted in saline."
10784337|NCT03789318|FG004|Participant Flow|Placebo for Cohorts 2 and 3|"Cohorts 2 & 3: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784338|NCT03789318|OG000|Outcome|CA-008 5 mg (0.05 mg/mL) Cohort 1|"Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~CA-008 5 mg: 5 mg CA-008 reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784339|NCT03789318|OG001|Outcome|Placebo for Cohort 1|"Cohort 1:~Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784340|NCT03789318|OG002|Outcome|CA-008 10 mg (0.1 mg/mL)|"Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 10 mg: 10 mg CA-008 reconstituted in saline."
10784341|NCT03789318|OG003|Outcome|CA-008 15 mg (0.15 mg/mL)|"Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 15 mg: 15 mg CA-008 reconstituted in saline."
10784342|NCT03789318|OG004|Outcome|Placebo for Cohorts 2 and 3|"Cohorts 2 & 3:~Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784343|NCT03789318|EG000|Reported Event|CA-008 5 mg (0.05 mg/mL) Cohort 1|"Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~CA-008 5 mg: 5 mg CA-008 reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784344|NCT03789318|EG001|Reported Event|Placebo for Cohort 1|"Cohort 1:~Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10803751|NCT02134028|FG000|Participant Flow|Participants From DRI12544: Placebo/Dupilumab|Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 milligram (mg) on Day 1 followed by a subcutaneous (SC) dose of dupilumab 300 mg every 2 weeks (q2w) for 96 weeks in combination with inhaled corticosteroid (ICS) therapy/long-acting beta-agonist (LABA) therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11381028|NCT04414618|BG000|Baseline|Opaganib|Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
10784345|NCT03789318|EG002|Reported Event|CA-008 10 mg (0.1 mg/mL)|"Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 10 mg: 10 mg CA-008 reconstituted in saline."
10784346|NCT03789318|EG003|Reported Event|CA-008 15 mg (0.15 mg/mL)|"Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery~CA-008 15 mg: 15 mg CA-008 reconstituted in saline."
10784347|NCT03789318|EG004|Reported Event|Placebo for Cohorts 2 and 3|"Cohorts 2 & 3:~Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.~The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).~Placebo: Each cohort will use placebo reconstituted in saline.~Bupivacaine Hydrochloride: 0.25% administered pre-surgery~Hydromorphone: 0.02 mg/kg IV administered intraoperatively~Fentanyl: 100 mcg IV administered intraoperatively~Acetaminophen: 1000 mg IV administered intraoperatively~Oxycodone: 5-10 mg PO administered post-surgery"
10784348|NCT03774875|BG000|Baseline|Placebo|Participants received placebo tablets orally twice a day for 16 weeks.
10784349|NCT03774875|BG001|Baseline|Apremilast 30 mg|Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
10784350|NCT03774875|BG002|Baseline|Total|Total of all reporting groups
10784351|NCT03774875|FG000|Participant Flow|Placebo|Participants received placebo tablets orally twice a day for 16 weeks.
10784352|NCT03774875|FG001|Participant Flow|Apremilast 30 mg|Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
10784353|NCT03774875|OG000|Outcome|Placebo|Participants received placebo tablets orally twice a day for 16 weeks.
10784354|NCT03774875|OG001|Outcome|Apremilast 30 mg|Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
10784355|NCT03774875|EG000|Reported Event|Placebo|Participants received placebo tablets orally twice a day for 16 weeks.
10784356|NCT03774875|EG001|Reported Event|Apremilast 30 mg|Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.
10801896|NCT02913222|BG000|Baseline|Movement Pattern Training (MPT)|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface.~Rehabilitation: Comparison of two rehabilitation approaches"
10801897|NCT02913222|BG001|Baseline|Standard Rehabilitation|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load.~Rehabilitation: Comparison of two rehabilitation approaches"
10801898|NCT02913222|BG002|Baseline|Total|Total of all reporting groups
10801899|NCT02913222|FG000|Participant Flow|Movement Pattern Training (MPT)|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface.~Rehabilitation: Comparison of two rehabilitation approaches"
10801900|NCT02913222|FG001|Participant Flow|Standard Rehabilitation|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load.~Rehabilitation: Comparison of two rehabilitation approaches"
10850634|NCT00303719|BG000|Baseline|High Risk Patients|Patients with refractory leukemia or MDS
11194308|NCT02151682|OG001|Outcome|Tapentadol Prolonged-release (6 Years to Less Than 12 Years)|"The treatment group comprised 12 participants aged 6 years to less than 12 years. Participants starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11381029|NCT04414618|BG001|Baseline|Placebo|Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
11194309|NCT02151682|OG002|Outcome|Tapentadol Prolonged-release (12 Years to Less Than 18 Years)|"The treatment group comprised 33 participants aged 12 years to less than 18 years. Participants starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11194310|NCT02151682|OG000|Outcome|Tapentadol in Part 2 After Tapentadol or Morphine in Part 1|"Participants on tapentadol PR in Part 1 of the study continued on the current dose of tapentadol PR in Part 2 and if necessary could modify their tapentadol PR dosage. Participants who were randomized to morphine PR in Part 1 of the study were rotated to tapentadol PR in Part 2 with 70 percent of their current morphine equivalent dose or lower.The dosage could be increased gradually up to approximately 4.5 mg/kg body weight tapentadol PR twice daily.~Tapentadol prolonged release"
11194311|NCT02151682|OG001|Outcome|Observation Period After Tapentadol in Part 1|Participants who completed tapentadol PR in Part 1 of the study or discontinued tapentadol treatment early in Part 1 could continue directly in the observation period in Part 2 for up to 12 months (with standard-of-care treatment if needed).
11381030|NCT04414618|BG002|Baseline|Total|Total of all reporting groups
11381031|NCT04414618|FG000|Participant Flow|Opaganib|"Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours~Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive)."
11381032|NCT04414618|FG001|Participant Flow|Placebo|"Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours~Placebo: Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive)."
11381033|NCT04414618|OG000|Outcome|Opaganib|Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
11381034|NCT04414618|OG001|Outcome|Placebo|Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
11381035|NCT04414618|OG001|Outcome|Placebo|Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
11381036|NCT04414618|EG000|Reported Event|Opaganib|"Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours~Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive)."
11381037|NCT04414618|EG001|Reported Event|Placebo|"Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours~Placebo: Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive)."
11381038|NCT04412057|BG000|Baseline|CERC-002|CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
11381039|NCT04412057|BG001|Baseline|Placebo|Placebo: Administered once subcutaneously
11381040|NCT04412057|BG002|Baseline|Total|Total of all reporting groups
11381041|NCT04412057|FG000|Participant Flow|CERC-002|CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
10784357|NCT03613662|BG000|Baseline|SP-102|"SP-102~SP-102: Injection"
11381042|NCT04412057|FG001|Participant Flow|Placebo|Placebo: Administered once subcutaneously
11381043|NCT04412057|OG000|Outcome|CERC-002|CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
11381044|NCT04412057|OG001|Outcome|Placebo|Placebo: Administered once subcutaneously
11381045|NCT04412057|EG000|Reported Event|CERC-002|CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
11381046|NCT04412057|EG001|Reported Event|Placebo|Placebo: Administered once subcutaneously
11381047|NCT04402060|BG000|Baseline|Part 1: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or resolution of ARDS (PaO2/FiO2 ratio >300 mm Hg), whichever occurred earlier. In addition, subjects received institutional SoC to treat their conditions.
11381048|NCT04402060|BG001|Baseline|Part 2: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381049|NCT04402060|BG002|Baseline|Part 2: Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381050|NCT04402060|BG003|Baseline|Total|Total of all reporting groups
11381051|NCT04402060|FG000|Participant Flow|Part 1: APL-9|Subjects received an initial intravenous (IV) infusion of 180 milligram (mg) APL-9 in 50 milliliter (mL) of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or resolution of ARDS (partial pressure of oxygen [PaO2]/fraction of inspired oxygen [FiO2] ratio >300 millimeter [mm] of mercury [Hg]), whichever occurred earlier. In addition, subjects received institutional SoC to treat their conditions.
11381052|NCT04402060|FG001|Participant Flow|Part 2: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
10784358|NCT03613662|FG000|Participant Flow|SP-102|"SP-102~SP-102: Injection"
10784359|NCT03613662|OG000|Outcome|SP-102|"SP-102~SP-102: Injection"
10784360|NCT03613662|EG000|Reported Event|SP-102|"SP-102~SP-102: Injection"
10784361|NCT03232736|BG000|Baseline|Healthy Control|Healthy controls free of heart disease and not on any medications. Age 18+ years
10784362|NCT03232736|BG001|Baseline|LVAD Group|Heart failure patients supported by LVAD
10784363|NCT03232736|BG002|Baseline|Total|Total of all reporting groups
10784364|NCT03232736|FG000|Participant Flow|Healthy Control|healthy individuals free of cardiovascular disease and not on any cardiac-related medications, age > 18years.
10784365|NCT03232736|FG001|Participant Flow|LVAD Group w/Pacemaker|"Pacemaker adjustments will be made to this group in blinded manner.~Pacemaker adjustments: LVAD subjects with CRT device will have leads turned both on and off in blinded manner~CRT: CRT device"
10784366|NCT03232736|OG000|Outcome|Healthy Control|healthy people free of heart disease.
10784367|NCT03232736|OG001|Outcome|LVAD Group w/Pacemaker|heart failure patients supported by an LVD.
10784368|NCT03232736|OG000|Outcome|Healthy Control|healthy people without cardiac disease
10784369|NCT03232736|OG001|Outcome|LVAD Group w/Pacemaker|heart failure patient supported by lvads.
11381053|NCT04402060|FG002|Participant Flow|Part 2: Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
10784370|NCT03232736|OG000|Outcome|Healthy Control|Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition
10784371|NCT03232736|OG001|Outcome|LVAD Group|Individuals with history of advanced heart failure who are supported by left ventricular assist devices
10784372|NCT03232736|EG000|Reported Event|Healthy Control|healthy people free of heart disease.
10784373|NCT03232736|EG001|Reported Event|LVAD Group w/Pacemaker|Heart failure patients supported by an LVAD.
10784374|NCT03208530|BG000|Baseline|Intervention Arm|"This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.~Brief motivational interview intervention: A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians."
10784375|NCT03208530|FG000|Participant Flow|Intervention Arm|"This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.~Brief motivational interview intervention: A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians."
10784376|NCT03208530|OG000|Outcome|Intervention Arm|"This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.~Brief motivational interview intervention: A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians."
10784377|NCT03208530|EG000|Reported Event|Intervention Arm|"This is a single arm study with all enrolled patients receiving the same brief motivational interview intervention.~Brief motivational interview intervention: A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians."
10784378|NCT03158688|BG000|Baseline|Kd - Carfilzomib and Dexamethasone|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles."
10784379|NCT03158688|BG001|Baseline|KdD - Carfilzomib, Dexamethasone and Daratumumab|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.~Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only."
10784380|NCT03158688|BG002|Baseline|Total|Total of all reporting groups
10784381|NCT03158688|FG000|Participant Flow|Kd - Carfilzomib and Dexamethasone|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles."
10784382|NCT03158688|FG001|Participant Flow|KdD - Carfilzomib, Dexamethasone and Daratumumab|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.~Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only."
10784383|NCT03158688|OG000|Outcome|Kd - Carfilzomib and Dexamethasone|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles."
10784384|NCT03158688|OG001|Outcome|KdD - Carfilzomib, Dexamethasone and Daratumumab|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.~Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only."
10784385|NCT03158688|EG000|Reported Event|Kd - Carfilzomib and Dexamethasone|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles."
10784386|NCT03158688|EG001|Reported Event|KdD - Carfilzomib, Dexamethasone and Daratumumab|"Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.~Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.~Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only."
10784387|NCT03103321|BG000|Baseline|Pre- and During-consultation Decision Aids|"Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784388|NCT03103321|BG001|Baseline|Pre-consultation Decision Aids Only|"Patients receive Knowing your Options decision aid before their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784389|NCT03103321|BG002|Baseline|During-consultation Decision Aids Only|"Patients receive Prostate Choice decision aid during their consultation visit.~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784390|NCT03103321|BG003|Baseline|Usual Care|"Patients undergo usual care.~Best Practice: Undergo usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784391|NCT03103321|BG004|Baseline|Total|Total of all reporting groups
10784392|NCT03103321|FG000|Participant Flow|Pre- and During-consultation Decision Aids|"Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11194312|NCT02151682|OG002|Outcome|Observation Period After Morphine in Part 1|Participants who completed morphine PR treatment in Part 1 of the study or discontinued early from morphine treatment in Part 1 could continue directly in the observation period in Part 2 (with standard-of-care treatment if needed).
11194313|NCT02151682|OG003|Outcome|Observation Period After Tapentadol in Part 2|Participants who completed tapentadol PR or morphine PR treatment in Part 1 of the study could enter the Observation Period for up to 12 months (with standard-of-care treatment if needed) after they had discontinued from tapentadol PR treatment in Part 2.
10784393|NCT03103321|FG001|Participant Flow|Pre-consultation Decision Aids Only|"Patients receive Knowing your Options decision aid before their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
11194314|NCT02151682|OG002|Outcome|Tapentadol Prolonged-release (Part 2)|"36 participants who completed Part 1 of the trial (26 on tapentadol PR and 10 participants on morphine PR) continued treatment or switched to treatment with tapentadol PR for up to 12 months in Part 2.~Participants on tapentadol PR in Part 1 continued on the current dose of tapentadol PR in Part 2 and if necessary could modify their tapentadol PR dosage. Participants on morphine PR in Part 1 were rotated to tapentadol PR in Part 2 with 70 percent of their current morphine equivalent dose or lower. The dosage could be increased gradually up to approximately 4.5 mg/kg body weight tapentadol PR twice daily."
11194315|NCT02151682|EG000|Reported Event|Morphine Prolonged-release (Part 1)|"The treatment group comprised 7 participants aged 6 years to less than 12 years and 17 participants aged 12 years to less than 18 years.~Starting doses varied from 10 to 40 milligrams (mg) morphine PR twice daily depending on participant's weight; if necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 200 mg per day."
10784394|NCT03103321|FG002|Participant Flow|During-consultation Decision Aids Only|"Patients receive Prostate Choice decision aid during their consultation visit.~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784395|NCT03103321|FG003|Participant Flow|Usual Care|"Patients undergo usual care.~Best Practice: Undergo usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784396|NCT03103321|OG000|Outcome|Pre- and During-consultation Decision Aids|"Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784397|NCT03103321|OG001|Outcome|Pre-consultation Decision Aids Only|"Patients receive Knowing your Options decision aid before their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784398|NCT03103321|OG002|Outcome|During-consultation Decision Aids Only|"Patients receive Prostate Choice decision aid during their consultation visit.~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784399|NCT03103321|OG003|Outcome|Usual Care|"Patients undergo usual care.~Best Practice: Undergo usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784400|NCT03103321|EG000|Reported Event|Pre- and During-consultation Decision Aids|"Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784401|NCT03103321|EG001|Reported Event|Pre-consultation Decision Aids Only|"Patients receive Knowing your Options decision aid before their consultation visit.~Internet-Based Intervention: Receive Knowing your Options decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784402|NCT03103321|EG002|Reported Event|During-consultation Decision Aids Only|"Patients receive Prostate Choice decision aid during their consultation visit.~Internet-Based Intervention: Receive Prostate Choice decision aid~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784403|NCT03103321|EG003|Reported Event|Usual Care|"Patients undergo usual care.~Best Practice: Undergo usual care~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Survey Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10784404|NCT03079869|BG000|Baseline|Ferric Citrate - Hemodialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784405|NCT03079869|BG001|Baseline|Ferric Citrate - Peritoneal Dialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784406|NCT03079869|BG002|Baseline|Total|Total of all reporting groups
10784407|NCT03079869|FG000|Participant Flow|Ferric Citrate - Hemodialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784408|NCT03079869|FG001|Participant Flow|Ferric Citrate - Peritoneal Dialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784409|NCT03079869|OG000|Outcome|Ferric Citrate - Hemodialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784410|NCT03079869|OG001|Outcome|Ferric Citrate - Peritoneal Dialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784411|NCT03079869|EG000|Reported Event|Ferric Citrate - Hemodialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784412|NCT03079869|EG001|Reported Event|Ferric Citrate - Peritoneal Dialysis|"Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.~Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption."
10784413|NCT03033875|BG000|Baseline|Tele-Savvy Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
11381054|NCT04402060|OG000|Outcome|Part 1: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or resolution of ARDS (PaO2/FiO2 ratio >300 mm Hg), whichever occurred earlier. In addition, subjects received institutional SoC to treat their conditions.
11381055|NCT04402060|OG001|Outcome|Part 2: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381056|NCT04402060|OG002|Outcome|Part 2: Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381057|NCT04402060|OG000|Outcome|Part 2: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381058|NCT04402060|OG001|Outcome|Part 2: Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381059|NCT04402060|OG000|Outcome|Part 2: APL-9 Plus SoC|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. Follow-up safety assessments were collected 30 days following the last dose of study treatment (with a +7-day window). All subjects received SoC independent of their randomization.
11381060|NCT04402060|OG001|Outcome|Part 2: Vehicle Control Plus SoC|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. Follow-up safety assessments were collected 30 days following the last dose of study treatment (with a +7-day window). All subjects received SoC independent of their randomization.
11381061|NCT04402060|OG002|Outcome|Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381062|NCT04402060|EG000|Reported Event|Part 1: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or resolution of ARDS (PaO2/FiO2 ratio >300 mm Hg), whichever occurred earlier. In addition, subjects received institutional SoC to treat their conditions.
10784414|NCT03033875|BG001|Baseline|Attention Control Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784415|NCT03033875|BG002|Baseline|Usual Care Group|Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
11241003|NCT02483676|EG000|Reported Event|Treadmill+Anklebot|"This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.~Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period."
11381063|NCT04402060|EG001|Reported Event|Part 2: APL-9|Subjects received an initial IV infusion of 180 mg APL-9 in 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 180 mg APL-9 in 250 mL saline at the rate of 15 mg/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions
11381064|NCT04402060|EG002|Reported Event|Part 2: Control|Subjects received an initial IV infusion of 50 mL of saline once over a 10-minute period, followed within 1 hour by continuous IV infusion of 250 mL saline at the rate of 21 mL/hour until Day 7 or up to and including Day 21, discontinuation of respiratory support (supplemental oxygen or mechanical ventilation), or hospital discharge, whichever occurred latest. In addition, subjects received institutional SoC to treat their conditions.
11381065|NCT04396626|BG000|Baseline|Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)|Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
10784416|NCT03033875|BG003|Baseline|Total|Total of all reporting groups
10784417|NCT03033875|FG000|Participant Flow|Tele-Savvy Group|"Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.~The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points."
10784418|NCT03033875|FG001|Participant Flow|Attention Control Group|"Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.~The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants are asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant also receives 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants convene weekly for a video conference centered on the application of healthy living strategies. Facilitators greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments."
10784419|NCT03033875|FG002|Participant Flow|Usual Care Group|Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784420|NCT03033875|OG000|Outcome|Tele-Savvy Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
10784421|NCT03033875|OG001|Outcome|Attention Control Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784422|NCT03033875|OG002|Outcome|Usual Care Group|Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784423|NCT03033875|EG000|Reported Event|Tele-Savvy Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
10784424|NCT03033875|EG001|Reported Event|Attention Control Group|Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784425|NCT03033875|EG002|Reported Event|Usual Care Group|Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
10784426|NCT02935595|BG000|Baseline|Ketamine|"Slow infusions of ketamine will take place over a time period of 40 minutes.~Ketamine: Ketamine Hydrochloride Injection"
10784427|NCT02935595|FG000|Participant Flow|Ketamine|"Slow infusions of ketamine will take place over a time period of 40 minutes.~Ketamine: Ketamine Hydrochloride Injection"
10784428|NCT02935595|OG000|Outcome|Ketamine|"Slow infusions of ketamine will take place over a time period of 40 minutes.~Ketamine: Ketamine Hydrochloride Injection"
10784429|NCT02935595|EG000|Reported Event|Ketamine|"Slow infusions of ketamine will take place over a time period of 40 minutes.~Ketamine: Ketamine Hydrochloride Injection"
10784430|NCT02887248|BG000|Baseline|Nab-paclitaxel+Gemcitabine|"Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.~Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment."
10784431|NCT02887248|FG000|Participant Flow|Nab-paclitaxel+Gemcitabine|"Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.~Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment."
10784432|NCT02887248|OG000|Outcome|Nab-paclitaxel+Gemcitabine|"Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.~Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment."
10803752|NCT02134028|FG001|Participant Flow|Participants From DRI12544: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10784433|NCT02887248|EG000|Reported Event|Nab-paclitaxel+Gemcitabine|"Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.~Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment."
10784434|NCT02849990|BG000|Baseline|Treatment (Neoadjuvant Chemotherapy)|"Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.~Abiraterone Acetate: Given PO~Apalutamide: Given PO~Degarelix: Given SC~Indomethacin: Given PO~Laboratory Biomarker Analysis: Correlative study~Prednisone: Given PO"
10784435|NCT02849990|FG000|Participant Flow|Treatment (Neoadjuvant Chemotherapy)|"Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.~Abiraterone Acetate: Given PO~Apalutamide: Given PO~Degarelix: Given SC~Indomethacin: Given PO~Laboratory Biomarker Analysis: Correlative study~Prednisone: Given PO"
10784436|NCT02849990|OG000|Outcome|Treatment (Neoadjuvant Chemotherapy)|"Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.~Abiraterone Acetate: Given PO~Apalutamide: Given PO~Degarelix: Given SC~Indomethacin: Given PO~Laboratory Biomarker Analysis: Correlative study~Prednisone: Given PO"
10784437|NCT02849990|EG000|Reported Event|Treatment (Neoadjuvant Chemotherapy)|"Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.~Abiraterone Acetate: Given PO~Apalutamide: Given PO~Degarelix: Given SC~Indomethacin: Given PO~Laboratory Biomarker Analysis: Correlative study~Prednisone: Given PO"
10784438|NCT02673151|BG000|Baseline|Diagnostic (68Ga-PSMA-11 PET/CT)|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784439|NCT02673151|FG000|Participant Flow|Diagnostic (68Ga-PSMA-11 PET/CT)|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784440|NCT02673151|OG000|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT)|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784441|NCT02673151|OG000|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.2 to < 0.5 ng/m?|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784442|NCT02673151|OG001|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784443|NCT02673151|OG002|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
11194316|NCT02151682|EG001|Reported Event|Tapentadol Prolonged-release (Part 1)|"The treatment group comprised 12 participants aged 6 years to less than 12 years and 33 participants aged 12 years to less than 18 years.~Starting doses varied from 25 to 100 mg tapentadol PR twice daily depending on participant's weight. If necessary, doses were gradually increased up to a maximum dose defined per weight group.~The highest dose defined for participants weighing 55 kg and more was 500 mg per day."
11194317|NCT02151682|EG002|Reported Event|Overall (Part 1)|"Overall (Part 1) includes all participants with a 2-week treatment with tapentadol PR or morphine PR tablets.~One participant who completed the tapentadol PR treatment in Part 1 died in the Observation Period (Part 2; standard-of-care treatment, no IMP) due to progression of Ewing's sarcoma, which started progressing in Part 1. A second participant died in the Observation Period after Tapentadol in Part 1 due to serious progression of osteosarcoma with fatal outcome. The progression started in the Observation Period."
10966617|NCT00887822|BG001|Baseline|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
10966618|NCT00887822|BG002|Baseline|Total|Total of all reporting groups
11194318|NCT02151682|EG003|Reported Event|Tapentadol Prolonged-release in Part 2|"Tapentadol prolonged release in Part 2 comprises all participants who completed Part 1 (on tapentadol PR or morphine PR) and continued on or switched to an extended treatment with tapentadol PR for up to 12 months.~No deaths were reported during treatment with tapentadol PR in Part 2. Following tapentadol PR treatment in Part 2, 1 participant died during the Observation Period (under standard-of-care treatment, no IMP) due to malignant neoplasm progression (sarcoma). The progression started in the Observation Period."
11381066|NCT04396626|FG000|Participant Flow|Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)|Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer (A/MBC) as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
11381067|NCT04396626|OG000|Outcome|Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)|Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
11381068|NCT04396626|EG000|Reported Event|Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) + Aromatase Inhibitor (AI)|Data for participants who received CDK4/6i along with AI as initial endocrine-based therapy for advanced and metastatic breast cancer as part of their routine clinical treatment, was to be accrued from the Concerto Health AI Definitive Oncology Dataset, during this retrospective observational study.
11381069|NCT04391179|BG000|Baseline|Dipyridamole 100 Milligram(mg)|"100 milligrams (mg) by mouth (PO) four times a day (QID)~Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital."
11381070|NCT04391179|BG001|Baseline|Placebo|"Placebo given by mouth four times a day~Placebo oral tablet: Placebo will be given for 14 days while in the hospital."
11381071|NCT04391179|BG002|Baseline|Total|Total of all reporting groups
11381072|NCT04391179|FG000|Participant Flow|Dipyridamole 100 Milligram(mg)|"100 milligrams (mg) by mouth (PO) four times a day (QID)~Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital."
11381073|NCT04391179|FG001|Participant Flow|Placebo|"Placebo given by mouth four times a day~Placebo oral tablet: Placebo will be given for 14 days while in the hospital."
11381074|NCT04391179|OG000|Outcome|Dipyridamole 100 Milligram(mg)|"100 milligrams (mg) by mouth (PO) four times a day (QID)~Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital."
11381075|NCT04391179|OG001|Outcome|Placebo|"Placebo given by mouth four times a day~Placebo oral tablet: Placebo will be given for 14 days while in the hospital."
11381076|NCT04391179|EG000|Reported Event|Dipyridamole 100 Milligram(mg)|"100 milligrams (mg) by mouth (PO) four times a day (QID)~Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital."
11381077|NCT04391179|EG001|Reported Event|Placebo|"Placebo given by mouth four times a day~Placebo oral tablet: Placebo will be given for 14 days while in the hospital."
11381078|NCT04386096|BG000|Baseline|Mehealth for ADHD Software With Medication Continuity Tools|Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
11381079|NCT04386096|BG001|Baseline|Mehealth for ADHD Software With no Medication Continuity Tools|"Mehealth for ADHD software with no medication continuity tools: The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician report card; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
11381080|NCT04386096|BG002|Baseline|Total|Total of all reporting groups
11381081|NCT04386096|FG000|Participant Flow|Mehealth for ADHD Software With Medication Continuity Tools|Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
11381082|NCT04386096|FG001|Participant Flow|Mehealth for ADHD Software With no Medication Continuity Tools|"Mehealth for ADHD software with no medication continuity tools: The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician report card; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
11381083|NCT04386096|OG000|Outcome|Mehealth for ADHD Software With Medication Continuity Tools|Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
11194319|NCT02151773|BG000|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
11194320|NCT02151773|FG000|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed.
11381084|NCT04386096|OG001|Outcome|Mehealth for ADHD Software With no Medication Continuity Tools|"Mehealth for ADHD software with no medication continuity tools: The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician report card; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
11381085|NCT04386096|EG000|Reported Event|Mehealth for ADHD Software With Medication Continuity Tools|Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
11381086|NCT04386096|EG001|Reported Event|Mehealth for ADHD Software With no Medication Continuity Tools|"Mehealth for ADHD software with no medication continuity tools: The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician report card; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
11381087|NCT04376684|BG000|Baseline|Part 1: Placebo 1|Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care.
11381088|NCT04376684|BG001|Baseline|Part 1: Otilimab 90 mg|Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
11381089|NCT04376684|BG002|Baseline|Part 2: Placebo 2|Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.
11381090|NCT04376684|BG003|Baseline|Part 2: Otilimab 90 mg|Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
11381091|NCT04376684|BG004|Baseline|Total|Total of all reporting groups
11381092|NCT04376684|FG000|Participant Flow|Part 1: Placebo 1|Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care.
11381093|NCT04376684|FG001|Participant Flow|Part 1: Otilimab 90 mg|Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
11381094|NCT04376684|FG002|Participant Flow|Part 2: Placebo 2|Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.
11381095|NCT04376684|FG003|Participant Flow|Part 2: Otilimab 90 mg|Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
11381096|NCT04376684|OG000|Outcome|Part 1: Placebo 1|Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care.
11381097|NCT04376684|OG001|Outcome|Part 1: Otilimab 90 mg|Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
11381098|NCT04376684|OG000|Outcome|Part 2: Placebo 2|Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.
11381099|NCT04376684|OG001|Outcome|Part 2: Otilimab 90 mg|Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
11381100|NCT04376684|EG000|Reported Event|Part 1: Placebo 1|Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care.
11381101|NCT04376684|EG001|Reported Event|Part 1: Otilimab 90 mg|Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
11381102|NCT04376684|EG002|Reported Event|Part 2: Placebo 2|Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.
11381103|NCT04376684|EG003|Reported Event|Part 2: Otilimab 90 mg|Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
11381104|NCT04353284|BG000|Baseline|Camostat Mesylate|"Camostat mesylate 200mg taken 7 days.~Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days."
11381105|NCT04353284|BG001|Baseline|Placebo|"Placebo taken for 7 days.~Placebo: Placebo taken orally, 4 times daily, for 7 days."
11381106|NCT04353284|BG002|Baseline|Total|Total of all reporting groups
11381107|NCT04353284|FG000|Participant Flow|Camostat Mesylate|"Camostat mesylate 200mg taken 7 days.~Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days."
11381108|NCT04353284|FG001|Participant Flow|Placebo|"Placebo taken for 7 days.~Placebo: Placebo taken orally, 4 times daily, for 7 days."
11381109|NCT04353284|OG000|Outcome|Camostat Mesylate|"Camostat mesylate 200mg taken 7 days.~Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days."
11381110|NCT04353284|OG001|Outcome|Placebo|"Placebo taken for 7 days.~Placebo: Placebo taken orally, 4 times daily, for 7 days."
11381111|NCT04353284|EG000|Reported Event|Camostat Mesylate|"Camostat mesylate 200mg taken 7 days.~Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days."
11381112|NCT04353284|EG001|Reported Event|Placebo|"Placebo taken for 7 days.~Placebo: Placebo taken orally, 4 times daily, for 7 days."
10784444|NCT02673151|OG003|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
11381113|NCT04294147|BG000|Baseline|140 mg Erenumab SC|Participants received a single SC dose of 140 mg Erenumab.
11381114|NCT04294147|BG001|Baseline|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11381115|NCT04294147|BG002|Baseline|Total|Total of all reporting groups
11381116|NCT04294147|FG000|Participant Flow|140 mg Erenumab SC|Participants received a single subcutaneous (SC) dose of 140 milligram (mg) Erenumab.
11381117|NCT04294147|FG001|Participant Flow|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11381118|NCT04294147|OG000|Outcome|140 mg Erenumab SC|Participants received a single SC dose of 140 mg Erenumab.
11381119|NCT04294147|OG001|Outcome|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11381120|NCT04294147|EG000|Reported Event|140 mg Erenumab SC|Participants received a single SC dose of 140 mg Erenumab.
11381121|NCT04294147|EG001|Reported Event|240 mg Galcanezumab SC|Participants received a single SC dose of 240 mg Galcanezumab.
11381122|NCT04269707|BG000|Baseline|IV Iron|"The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days.~Ferric carboxymaltose: IV iron"
11381123|NCT04269707|FG000|Participant Flow|IV Iron|"The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044, NCT03523117 can be referenced to make the information accessible.], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days.~Ferric carboxymaltose: IV iron"
11381124|NCT04269707|OG000|Outcome|IV Iron|"The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days.~Ferric carboxymaltose: IV iron"
11381125|NCT04269707|EG000|Reported Event|IV Iron|"The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days.~Ferric carboxymaltose: IV iron"
11381126|NCT04231825|BG000|Baseline|Verum Stimulation|"This group will receive 6-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381127|NCT04231825|BG001|Baseline|Frequency Control|"This group will receive 1-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381128|NCT04231825|BG002|Baseline|Total|Total of all reporting groups
11381129|NCT04231825|FG000|Participant Flow|Verum Stimulation|"This group will receive 6-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381130|NCT04231825|FG001|Participant Flow|Frequency Control|"This group will receive 1-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381131|NCT04231825|OG000|Outcome|Verum Stimulation|"This group will receive 6-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381132|NCT04231825|OG001|Outcome|Frequency Control|"This group will receive 1-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381133|NCT04231825|EG000|Reported Event|Verum Stimulation|"This group will receive 6-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381134|NCT04231825|EG001|Reported Event|Frequency Control|"This group will receive 1-Hz tACS~Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4."
11381135|NCT04196686|BG000|Baseline|All Participants|Participants placed their dominant or non-dominant hand in ice bath with or without the use of VR/AR, then crossed to place their opposite hand in ice bath using the opposite treatment or control
11381136|NCT04196686|FG000|Participant Flow|Ice Bath Control Then VR/AR|Participants placed their dominant or non-dominant hand in ice bath without the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath with the use of VR/AR
11381137|NCT04196686|FG001|Participant Flow|Ice Bath With VR/AR Then Control|Participants placed their dominant or non-dominant hand in ice bath with the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath without the use of VR/AR
11381138|NCT04196686|OG000|Outcome|Ice Bath Control|Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR
11381139|NCT04196686|OG001|Outcome|Ice Bath With VR/AR|Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
11381140|NCT04196686|EG000|Reported Event|Ice Bath Control|Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR
11381141|NCT04196686|EG001|Reported Event|Ice Bath With VR/AR|Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
11381142|NCT04178772|BG000|Baseline|Dispensed Subject|All subjects dispensed a study lens.
11381143|NCT04178772|FG000|Participant Flow|Etafilcon A Multifocal Lens|Subjects that wore the etafilcon A lens during any point of the study.
11381144|NCT04178772|OG000|Outcome|Etafilcon A Multifocal Lens|Subjects that wore the etafilcon A lens during any point of the study.
11381145|NCT04178772|EG000|Reported Event|Etafilcon A Multifocal Lens|Subjects that wore the etafilcon A lens during any point of the study.
11381146|NCT04148651|BG000|Baseline|CO2RE® Treatment|"All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.~The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for treatment of leukoplakia (vulvar dystrophies)."
11381147|NCT04148651|FG000|Participant Flow|CO2RE® Treatment|"All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen.~The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN)."
11381148|NCT04148651|OG000|Outcome|CO2RE® Treatment|"All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.~The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN)."
11381149|NCT04148651|OG000|Outcome|Subjects Treated With CO2RE® Treatment|All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
11381150|NCT04148651|EG000|Reported Event|Subjects Treated With CO2RE® Treatment|All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
11381151|NCT04113304|BG000|Baseline|Intervention|Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
11381152|NCT04113304|FG000|Participant Flow|Intervention|Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
11381153|NCT04113304|OG000|Outcome|Intervention|Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
11381154|NCT04113304|EG000|Reported Event|Intervention|Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
10784445|NCT02673151|OG004|Outcome|Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784446|NCT02673151|EG000|Reported Event|Diagnostic (68Ga-PSMA-11 PET/CT)|"Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.~68Ga-PSMA-11: Given IV~Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT~Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT"
10784447|NCT02523274|BG000|Baseline|Placebo|"Placebo capsules will be taken orally following each meal three times daily~Placebo: Vegetable-based cellulose"
10784448|NCT02523274|BG001|Baseline|Resveratrol 500 mg/Day|"500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784449|NCT02523274|BG002|Baseline|Resveratrol 1000 mg/Day|"1000 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784450|NCT02523274|BG003|Baseline|Total|Total of all reporting groups
10784451|NCT02523274|FG000|Participant Flow|Placebo|"Placebo capsules will be taken orally following each meal three times daily~Placebo: Vegetable-based cellulose"
10784452|NCT02523274|FG001|Participant Flow|Resveratrol 500 mg/Day|"500 mg/day resveratrol taken orally via capsule following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages"
10784453|NCT02523274|FG002|Participant Flow|Resveratrol 1000 mg/Day|"1000 mg/day resveratrol taken orally via capsule following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages"
10784454|NCT02523274|OG000|Outcome|Placebo|"Placebo capsules will be taken orally following each meal three times daily~Placebo: Vegetable-based cellulose"
10784455|NCT02523274|OG001|Outcome|Resveratrol 500 mg/Day|"500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages"
10784456|NCT02523274|OG002|Outcome|Resveratrol 1000 mg/Day|"1000 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784457|NCT02523274|OG001|Outcome|Resveratrol 500 mg/Day|"500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1500 mg/day dosages"
10784458|NCT02523274|OG001|Outcome|Resveratrol 500 mg/Day|"500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784459|NCT02523274|OG001|Outcome|Resveratrol 500 mg/Day|"1000 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784460|NCT02523274|OG002|Outcome|Resveratrol 1000 mg/Day|"1500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784461|NCT02523274|EG000|Reported Event|Placebo|"Placebo capsules will be taken orally following each meal three times daily~Placebo: Vegetable-based cellulose"
10784462|NCT02523274|EG001|Reported Event|Resveratrol 500 mg/Day|"1000 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784463|NCT02523274|EG002|Reported Event|Resveratrol 1000 mg/Day|"1500 mg/day resveratrol taken orally following each meal three times daily~Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages"
10784464|NCT02467270|BG000|Baseline|Cohort A: Ponatinib 45 mg|Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784465|NCT02467270|BG001|Baseline|Cohort B: Ponatinib 30 mg|Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784466|NCT02467270|BG002|Baseline|Cohort C: Ponatinib 15 mg|Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.
10784467|NCT02467270|BG003|Baseline|Total|Total of all reporting groups
10784468|NCT02467270|FG000|Participant Flow|Cohort A: Ponatinib 45 mg|Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784469|NCT02467270|FG001|Participant Flow|Cohort B: Ponatinib 30 mg|Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784470|NCT02467270|FG002|Participant Flow|Cohort C: Ponatinib 15 mg|Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.
10784471|NCT02467270|OG000|Outcome|Cohort A: Ponatinib 45 mg|Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784472|NCT02467270|OG001|Outcome|Cohort B: Ponatinib 30 mg|Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784473|NCT02467270|OG002|Outcome|Cohort C: Ponatinib 15 mg|Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.
11381155|NCT03929588|BG000|Baseline|Refraction With a Hand-held Device Supported by Mobile App.|"BCVA with handheld device with app.~Phoropter: Manual refraction and ETDRS chart~Autorefractor: Automated refraction"
11381156|NCT03929588|FG000|Participant Flow|All Participants|"BCVA with handheld device with app.~Phoropter: Manual refraction and ETDRS chart~Autorefractor: Automated refraction"
11381157|NCT03929588|OG000|Outcome|All Participants|"BCVA with handheld device with app.~Phoropter: Manual refraction and ETDRS chart~Autorefractor: Automated refraction"
11381158|NCT03929588|EG000|Reported Event|Refraction With a Hand-held Device Supported by Mobile App.|"BCVA with handheld device with app.~Phoropter: Manual refraction and ETDRS chart~Autorefractor: Automated refraction"
11381159|NCT03893448|BG000|Baseline|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381160|NCT03893448|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381161|NCT03893448|BG002|Baseline|Total|Total of all reporting groups
11381162|NCT03893448|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381163|NCT03893448|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381164|NCT03893448|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381165|NCT03893448|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381166|NCT03893448|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381167|NCT03893448|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381168|NCT03893448|EG002|Reported Event|Cross-treated Participants|One participant assigned to the Prevnar 13™ arm who inadvertently received both V114 and Prevnar 13™. The participant received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and a single 0.5 mL IM injection of V114 Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). The participant concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
11381169|NCT03870880|BG000|Baseline|Rollover Placebo/Risperidone ISM 75 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381170|NCT03870880|BG001|Baseline|Rollover Risperidone ISM 75mg/Risperidone ISM 75mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
10784474|NCT02467270|EG000|Reported Event|Cohort A: Ponatinib 45 mg|Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784475|NCT02467270|EG001|Reported Event|Cohort B: Ponatinib 30 mg|Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
10784476|NCT02467270|EG002|Reported Event|Cohort C: Ponatinib 15 mg|Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.
10784477|NCT02452554|BG000|Baseline|Stratum 1: Wims Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784478|NCT02452554|BG001|Baseline|Stratum 2: Rhabdomyosarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784479|NCT02452554|BG002|Baseline|Stratum 3: Neuroblastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784480|NCT02452554|BG003|Baseline|Stratum 4: Pleuropulmonary Blastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784481|NCT02452554|BG004|Baseline|Stratum 5: Malignant Peripheral Nerve Sheath Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784482|NCT02452554|BG005|Baseline|Stratum 6: Synovial Sarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784483|NCT02452554|BG006|Baseline|Total|Total of all reporting groups
10784484|NCT02452554|FG000|Participant Flow|Stratum 1: Wims Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784485|NCT02452554|FG001|Participant Flow|Stratum 2: Rhabdomyosarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784486|NCT02452554|FG002|Participant Flow|Stratum 3: Neuroblastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784487|NCT02452554|FG003|Participant Flow|Stratum 4: Pleuropulmonary Blastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784488|NCT02452554|FG004|Participant Flow|Stratum 5: Malignant Peripheral Nerve Sheath Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784489|NCT02452554|FG005|Participant Flow|Stratum 6: Synovial Sarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784490|NCT02452554|OG000|Outcome|Stratum 1: Wims Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784491|NCT02452554|OG001|Outcome|Stratum 2: Rhabdomyosarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784492|NCT02452554|OG002|Outcome|Stratum 3: Neuroblastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784493|NCT02452554|OG003|Outcome|Stratum 4: Pleuropulmonary Blastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784494|NCT02452554|OG004|Outcome|Stratum 5: Malignant Peripheral Nerve Sheath Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784495|NCT02452554|OG005|Outcome|Stratum 6: Synovial Sarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784496|NCT02452554|OG000|Outcome|Treatment (Lorvotuzumab Mertansine)|"Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lorvotuzumab Mertansine: Given IV~Pharmacological Study: Correlative studies"
10784497|NCT02452554|EG000|Reported Event|Stratum 1: Wims Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784498|NCT02452554|EG001|Reported Event|Stratum 2: Rhabdomyosarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784499|NCT02452554|EG002|Reported Event|Stratum 3: Neuroblastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784500|NCT02452554|EG003|Reported Event|Stratum 4: Pleuropulmonary Blastoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784501|NCT02452554|EG004|Reported Event|Stratum 5: Malignant Peripheral Nerve Sheath Tumor|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784502|NCT02452554|EG005|Reported Event|Stratum 6: Synovial Sarcoma|ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
10784503|NCT02427568|BG000|Baseline|Placebo With Therapy|"Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose.~Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart."
10784504|NCT02427568|BG001|Baseline|MDMA-assisted Therapy (125 mg)|"125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA.~MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart."
10784505|NCT02427568|BG002|Baseline|Total|Total of all reporting groups
10784506|NCT02427568|FG000|Participant Flow|Placebo With Therapy|"Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose.~Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart."
10784507|NCT02427568|FG001|Participant Flow|MDMA-assisted Therapy (125 mg)|"125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA.~MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart."
10784508|NCT02427568|OG000|Outcome|Placebo With Therapy|"Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by inactive placebo supplemental dose.~Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart."
10784509|NCT02427568|OG001|Outcome|MDMA-assisted Therapy (125 mg)|"125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose of 62.5 mg MDMA.~MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart."
10784510|NCT02427568|EG000|Reported Event|Placebo With Therapy (Blinded)|"Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose.~Placebo with therapy: Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart."
10784511|NCT02427568|EG001|Reported Event|MDMA-assisted Therapy (125 mg) (Blinded)|"125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.~MDMA-assisted therapy: Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart."
10784512|NCT02427568|EG002|Reported Event|Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg)|Unblinded Crossover 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 3 open-label experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.
10784513|NCT02427568|EG003|Reported Event|MDMA Group Open-label MDMA-assisted Therapy (125 mg)|Open-Label 125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered during open-label 1 experimental session. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.
10784514|NCT02427568|EG004|Reported Event|Placebo With Therapy Group 6-month Follow-up|Follow-up with placebo with therapy group 6 months after end of Stage 2
10784515|NCT02427568|EG005|Reported Event|MDMA-assisted Therapy Group 6-month Follow-up|Follow-up with MDMA-assisted therapy group 6 months after end of Stage 2
10784516|NCT02318277|BG000|Baseline|Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784517|NCT02318277|BG001|Baseline|Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784518|NCT02318277|BG002|Baseline|Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)|Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784519|NCT02318277|BG003|Baseline|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784520|NCT02318277|BG004|Baseline|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784521|NCT02318277|BG005|Baseline|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784522|NCT02318277|BG006|Baseline|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784523|NCT02318277|BG007|Baseline|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784524|NCT02318277|BG008|Baseline|Total|Total of all reporting groups
10784525|NCT02318277|FG000|Participant Flow|Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784526|NCT02318277|FG001|Participant Flow|Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784527|NCT02318277|FG002|Participant Flow|Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)|Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784528|NCT02318277|FG003|Participant Flow|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784529|NCT02318277|FG004|Participant Flow|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784530|NCT02318277|FG005|Participant Flow|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784531|NCT02318277|FG006|Participant Flow|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784532|NCT02318277|FG007|Participant Flow|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
11381171|NCT03870880|BG002|Baseline|De Novo/Risperidone ISM 75mg|Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day.
11381172|NCT03870880|BG003|Baseline|Rollover Placebo/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381173|NCT03870880|BG004|Baseline|Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381174|NCT03870880|BG005|Baseline|De Novo/Risperidone ISM 100 mg|Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
11381175|NCT03870880|BG006|Baseline|Total|Total of all reporting groups
11381176|NCT03870880|FG000|Participant Flow|Rollover Placebo/Risperidone ISM 75 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381177|NCT03870880|FG001|Participant Flow|Rollover Risperidone ISM 75mg/Risperidone ISM 75mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381178|NCT03870880|FG002|Participant Flow|De Novo/Risperidone ISM 75mg|Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day.
11381179|NCT03870880|FG003|Participant Flow|Rollover Placebo/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381180|NCT03870880|FG004|Participant Flow|Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381181|NCT03870880|FG005|Participant Flow|De Novo/Risperidone ISM 100 mg|Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
11381182|NCT03870880|OG000|Outcome|Rollover Placebo/Risperidone ISM 75 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381183|NCT03870880|OG001|Outcome|Rollover Risperidone ISM 75mg/Risperidone ISM 75mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381184|NCT03870880|OG002|Outcome|De Novo/Risperidone ISM 75mg|Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day.
11381185|NCT03870880|OG003|Outcome|Rollover Placebo/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive either Risperidone ISM 100 mg during the OLE study.
11381186|NCT03870880|OG004|Outcome|Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381187|NCT03870880|OG005|Outcome|De Novo/Risperidone ISM 100 mg|Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM® in the OLE study. Their previous oral risperidon was more than 4 mg/day to a maximum of 6 mg/day
11381188|NCT03870880|OG001|Outcome|Rollover Risperidone 75 mg/Risperidone 75 mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381189|NCT03870880|OG002|Outcome|De Novo/Risperidone ISM 75 mg|Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day.
11381190|NCT03870880|OG003|Outcome|Rollover Placebo/Risperidone ISM 100 mg|Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381191|NCT03870880|OG005|Outcome|De Novo/Risperidone ISM 100 mg|Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
11381192|NCT03870880|OG001|Outcome|Risperidone ISM 75 mg/Risperidone ISM 75 mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381193|NCT03870880|OG004|Outcome|Risperidone ISM 100/Risperidone ISM 100|Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study.
11381194|NCT03870880|OG001|Outcome|Rollover Risperidone ISM 75mg/Risperidone ISM 75mg|Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
11381195|NCT03870880|OG000|Outcome|Risperidone ISM 75 mg|"Patients assigned to this arm received 75 mg of Risperidone ISM during the open label extension.~Risperidone ISM 75 mg: Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle."
11381196|NCT03870880|OG001|Outcome|Risperidone ISM 100 mg|"Patients assigned to this arm received 100 mg of Risperidone ISM during the open label extension.~Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle."
11381197|NCT03870880|EG000|Reported Event|Risperidone ISM 75 mg|"Patients assigned to this arm will received 75 mg of Risperidone ISM during the open label extension.~Risperidone ISM 75 mg: Monthly intramuscular (IM) injection in the gluteal or deltoid muscle.~Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates."
11381198|NCT03870880|EG001|Reported Event|Risperidone ISM 100 mg|"Patients assigned to this arm will received 100 mg of Risperidone ISM during the open label extension.~Risperidone ISM 100 mg: Monthly IM injection in the gluteal or deltoid muscle.~Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates."
11381199|NCT03831347|BG000|Baseline|Hatha Yoga|"12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.~Hatha Yoga: 12 weeks of Hatha Yoga"
11381200|NCT03831347|FG000|Participant Flow|Hatha Yoga|"12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.~Hatha Yoga: 12 weeks of Hatha Yoga"
11381201|NCT03831347|OG000|Outcome|Hatha Yoga|"12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.~Hatha Yoga: 12 weeks of Hatha Yoga"
11381202|NCT03831347|EG000|Reported Event|Hatha Yoga|"12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.~Hatha Yoga: 12 weeks of Hatha Yoga"
11381203|NCT03814590|BG000|Baseline|Low Dose_PLAIN_A Group|Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381204|NCT03814590|BG001|Baseline|Medium Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381205|NCT03814590|BG002|Baseline|High Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381206|NCT03814590|BG003|Baseline|Placebo_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381207|NCT03814590|BG004|Baseline|Low Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381208|NCT03814590|BG005|Baseline|Medium Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381209|NCT03814590|BG006|Baseline|High Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381210|NCT03814590|BG007|Baseline|Low Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381211|NCT03814590|BG008|Baseline|Medium Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381212|NCT03814590|BG009|Baseline|High Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381213|NCT03814590|BG010|Baseline|Low Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381214|NCT03814590|BG011|Baseline|Medium Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381215|NCT03814590|BG012|Baseline|High Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381216|NCT03814590|BG013|Baseline|Placebo_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381217|NCT03814590|BG014|Baseline|Total|Total of all reporting groups
11381218|NCT03814590|FG000|Participant Flow|Low Dose_PLAIN_A Group|Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381219|NCT03814590|FG001|Participant Flow|Medium Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381220|NCT03814590|FG002|Participant Flow|High Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381221|NCT03814590|FG003|Participant Flow|Placebo_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381222|NCT03814590|FG004|Participant Flow|Low Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381223|NCT03814590|FG005|Participant Flow|Medium Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381224|NCT03814590|FG006|Participant Flow|High Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11194321|NCT02151773|OG000|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
11194322|NCT02151773|EG000|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
11194323|NCT02151786|BG000|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
11194324|NCT02151786|FG000|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
11194325|NCT02151786|OG000|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
11381225|NCT03814590|FG007|Participant Flow|Low Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381226|NCT03814590|FG008|Participant Flow|Medium Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381227|NCT03814590|FG009|Participant Flow|High Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381228|NCT03814590|FG010|Participant Flow|Low Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381229|NCT03814590|FG011|Participant Flow|Medium Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381230|NCT03814590|FG012|Participant Flow|High Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381231|NCT03814590|FG013|Participant Flow|Placebo_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11194326|NCT02151786|EG000|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
11194327|NCT02151851|BG000|Baseline|Placebo + Methotrexate|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
11194328|NCT02151851|BG001|Baseline|Certolizumab Pegol + Methotrexate|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
11194329|NCT02151851|BG002|Baseline|Total Title|
11241004|NCT02483676|EG001|Reported Event|Treadmill Only|"This group will receive gait training on a treadmill, without use of the anklebot.~Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period"
11381232|NCT03814590|OG000|Outcome|Low Dose_PLAIN_A Group|Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381233|NCT03814590|OG001|Outcome|Medium Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381234|NCT03814590|OG002|Outcome|High Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381235|NCT03814590|OG003|Outcome|Placebo_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381236|NCT03814590|OG004|Outcome|Low Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381237|NCT03814590|OG005|Outcome|Medium Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381238|NCT03814590|OG006|Outcome|High Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381239|NCT03814590|OG007|Outcome|Low Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381240|NCT03814590|OG008|Outcome|Medium Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381241|NCT03814590|OG009|Outcome|High Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381242|NCT03814590|OG010|Outcome|Low Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
10784533|NCT02318277|OG000|Outcome|Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784534|NCT02318277|OG001|Outcome|Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784535|NCT02318277|OG002|Outcome|Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)|Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784536|NCT02318277|OG003|Outcome|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784537|NCT02318277|OG004|Outcome|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784538|NCT02318277|OG005|Outcome|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784539|NCT02318277|OG000|Outcome|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784540|NCT02318277|OG001|Outcome|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784541|NCT02318277|OG006|Outcome|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784542|NCT02318277|OG007|Outcome|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784543|NCT02318277|OG000|Outcome|Phase I : Epacadostat (25 mg) + Durvalumab|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 or 10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
11194330|NCT02151851|FG000|Participant Flow|Placebo + Methotrexate|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
10784544|NCT02318277|OG001|Outcome|Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)|Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784545|NCT02318277|OG002|Outcome|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784546|NCT02318277|OG003|Outcome|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784547|NCT02318277|OG004|Outcome|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784548|NCT02318277|OG005|Outcome|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784549|NCT02318277|OG006|Outcome|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784550|NCT02318277|OG003|Outcome|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Edit|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784551|NCT02318277|OG004|Outcome|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle
10784552|NCT02318277|OG005|Outcome|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Edit|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784553|NCT02318277|OG006|Outcome|Phase 2 Stage 1: Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).
10784554|NCT02318277|OG007|Outcome|Phase 2 Stage 2: Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).
10784555|NCT02318277|EG000|Reported Event|Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784556|NCT02318277|EG001|Reported Event|Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)|Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784557|NCT02318277|EG002|Reported Event|Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)|Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784558|NCT02318277|EG003|Reported Event|Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)|Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784559|NCT02318277|EG004|Reported Event|Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784560|NCT02318277|EG005|Reported Event|Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
10784561|NCT02318277|EG006|Reported Event|Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)|Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784562|NCT02318277|EG007|Reported Event|Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)|Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
10784563|NCT02296801|BG000|Baseline|A: Letrozole|"letrozole 2.5 mg tablet orally daily for 14 weeks~Letrozole"
10784564|NCT02296801|BG001|Baseline|B: Letrozole Then Letrozole + Palbociclib|"letrozole 2.5 mg orally daily plus beginning 2 weeks after starting letrozole, palbociclib 125 mg capsule orally daily for 1 week then 1 week off, then a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784565|NCT02296801|BG002|Baseline|C: Palbociclib Then Letrozole + Palbociclib|"palbociclib 125 mg capsule orally daily (for a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of palbociclib) plus beginning 2 weeks after starting palbociclib, letrozole 2.5 mg tablet orally daily for a total of 12 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784566|NCT02296801|BG003|Baseline|D: Letrozole + Palbociclib|"letrozole 2.5 mg tablet orally daily for a total of 14 weeks plus palbociclib 125 mg capsule orally daily for a 3 weeks on and 1 week off cycle, for a total of 14 weeks from start of therapy~Letrozole~palbociclib"
10784567|NCT02296801|BG004|Baseline|Total|Total of all reporting groups
10784568|NCT02296801|FG000|Participant Flow|A: Letrozole|"letrozole 2.5 mg tablet orally daily for 14 weeks~Letrozole"
10784569|NCT02296801|FG001|Participant Flow|B: Letrozole Then Letrozole + Palbociclib|"letrozole 2.5 mg orally daily plus beginning 2 weeks after starting letrozole, palbociclib 125 mg capsule orally daily for 1 week then 1 week off, then a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784570|NCT02296801|FG002|Participant Flow|C: Palbociclib Then Letrozole + Palbociclib|"palbociclib 125 mg capsule orally daily (for a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of palbociclib) plus beginning 2 weeks after starting palbociclib, letrozole 2.5 mg tablet orally daily for a total of 12 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784571|NCT02296801|FG003|Participant Flow|D: Letrozole + Palbociclib|"letrozole 2.5 mg tablet orally daily for a total of 14 weeks plus palbociclib 125 mg capsule orally daily for a 3 weeks on and 1 week off cycle, for a total of 14 weeks from start of therapy~Letrozole~palbociclib"
10784572|NCT02296801|OG000|Outcome|A: Letrozole|"letrozole 2.5 mg tablet orally daily for 14 weeks~Letrozole"
10784573|NCT02296801|OG001|Outcome|B, C + D Palbociclib + Letrozole Regimen|Comparison between Group A and Group (B,C+D).
10784574|NCT02296801|OG001|Outcome|B: Letrozole Then Letrozole + Palbociclib|"letrozole 2.5 mg orally daily plus beginning 2 weeks after starting letrozole, palbociclib 125 mg capsule orally daily for 1 week then 1 week off, then a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784575|NCT02296801|OG002|Outcome|C: Palbociclib Then Letrozole + Palbociclib|"palbociclib 125 mg capsule orally daily (for a 3 weeks on and 1 week off cycle for a total of 14 weeks from start of palbociclib) plus beginning 2 weeks after starting palbociclib, letrozole 2.5 mg tablet orally daily for a total of 12 weeks from start of letrozole therapy~Letrozole~palbociclib"
10784576|NCT02296801|OG003|Outcome|D: Letrozole + Palbociclib|"letrozole 2.5 mg tablet orally daily for a total of 14 weeks plus palbociclib 125 mg capsule orally daily for a 3 weeks on and 1 week off cycle, for a total of 14 weeks from start of therapy~Letrozole~palbociclib"
10784577|NCT02296801|OG004|Outcome|B, C + D Palbociclib + Letrozole Regimen|Comparison between Group A and Group (B,C+D).
10784578|NCT02296801|OG001|Outcome|B,C+D Palbociclib +Letrozole Regimen|Comparison between Group A & Group B,C+D
10784579|NCT02296801|OG001|Outcome|B+D+C Palbociclib + Letrozole Regimen|Comparison between Group A and Group (B,C+D).
10784580|NCT02296801|OG004|Outcome|B+D+C Palbociclib + Letrozole Regimen|Comparison between Group A and Group (B,C+D)
10784581|NCT02296801|OG001|Outcome|B+D+C Palbociclib + Letrozole Regimen|Comparison between Group A and Groups (B,C+D).
10784582|NCT02296801|EG000|Reported Event|A: Letrozole|"letrozole 2.5 mg tablet orally daily for 14 weeks~Letrozole"
10784583|NCT02296801|EG001|Reported Event|B+D+C Palbociclib + Letrozole Regimen|Comparison between Group A and Group (B,C+D).
10784584|NCT02143063|BG000|Baseline|Standard Care|"standard care~standard care"
10784585|NCT02143063|BG001|Baseline|Standard Care Plus Traditional Contingency Managment|"prize contingency management on a traditional twice weekly schedule for cocaine abstinence~prize contingency management on a traditional twice weekly schedule for cocaine abstinence~standard care"
10784586|NCT02143063|BG002|Baseline|Standard Care Plus Variable Interval Contingency Management|"prize contingency management on a variable interval schedule for cocaine abstinence~prize contingency management on a variable interval schedule for cocaine abstinence~standard care"
10784587|NCT02143063|BG003|Baseline|Total|Total of all reporting groups
10803753|NCT02134028|FG002|Participant Flow|Participants From EFC13579: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10784588|NCT02143063|FG000|Participant Flow|Standard Care (SC)|Standard care IOP treatment for cocaine use disorder. In addition, SC participants submitted urine samples during the 24-week intervention phase. Patients selected two days a week on which drug screens might occur (e.g., M/Th, T/F). On the morning of each potential drug screen day, research staff texted participants to indicate if a sample was due. In weeks 1-3, urine screens occurred on two days per week. In weeks 4-9, screens occurred on one randomly selected day each week. In weeks 10-24, drug screens occurred once every 2-3 weeks on average. After a missed sample, the next two screen days were prompted for sample submission. An algorithm developed in-house was used to generate and monitor the drug screen schedule. Participants received $2 per requested sample submitted plus a $20 bonus for submitting all requested samples in a 4-week period. The goal was to result in 18 samples on average, equivalent relative to the new SC plus variable interval CM condition.
10784589|NCT02143063|FG001|Participant Flow|Standard Care Plus Traditional Contingency Management|"Standard care plus standard prize contingency management twice weekly for urine screens indicating cocaine abstinence. Urine screens occurred on the same monitoring schedule described for the SC condition, including $2 per requested sample submitted and a $20 bonus for all requested samples in a 4-week period. In addition, participants received chances for prizes on a escalating reinforcement schedule and with a reset condition for unexcused missed samples. Mean maximum earnings for cocaine-negative urine screens was $460 in prizes."
10784590|NCT02143063|FG002|Participant Flow|Standard Care Plus Variable Interval Contingency Management|Standard care plus prize contingency management on a variable interval schedule for cocaine abstinence. Relative to the traditional CM condition, in this condition, the frequency of samples to earn reinforcement decreased over time contingent on achieving periods of sustained abstinence. The schedule was designed to result in an average of at least 18 urine samples over 24 weeks among participants maintaining abstinence. Participants received the sample compensation for submitted urine samples regardless of results as in the other two conditions.
10784591|NCT02143063|OG000|Outcome|Standard Care|"standard care~standard care"
10784592|NCT02143063|OG001|Outcome|Standard Care Plus Traditional Contingency Managment|"prize contingency management on a traditional twice weekly schedule for cocaine abstinence~prize contingency management on a traditional twice weekly schedule for cocaine abstinence~standard care"
10784593|NCT02143063|OG002|Outcome|Standard Care Plus Variable Interval Contingency Management|"prize contingency management on a variable interval schedule for cocaine abstinence~prize contingency management on a variable interval schedule for cocaine abstinence~standard care"
10784594|NCT02143063|EG000|Reported Event|Standard Care|"standard care~standard care"
10784595|NCT02143063|EG001|Reported Event|Standard Care Plus Traditional Contingency Managment|"prize contingency management on a traditional twice weekly schedule for cocaine abstinence~prize contingency management on a traditional twice weekly schedule for cocaine abstinence~standard care"
10784596|NCT02143063|EG002|Reported Event|Standard Care Plus Variable Interval Contingency Management|"prize contingency management on a variable interval schedule for cocaine abstinence~prize contingency management on a variable interval schedule for cocaine abstinence~standard care"
10784597|NCT02017964|BG000|Baseline|All Eligible Patients (Combination Chemotherapy)|All eligible patients enrolled on the study
10784598|NCT02017964|FG000|Participant Flow|All Patients (Combination Chemotherapy)|All patients enrolled on the study. Patients received 3-5 cycles of therapy which included cyclophosphamide (800 mg/m2/day), vincristine (1.5 mg/m2/day), methotrexate (5,000 mg/m2), etoposide (150 mg/m2/dose) and carboplatin (200 mg/m2/day IV).
10784599|NCT02017964|OG000|Outcome|All Eligible Patients (Combination Chemotherapy)|All eligible patients enrolled on the study
11194331|NCT02151851|FG001|Participant Flow|Certolizumab Pegol + Methotrexate|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
10784600|NCT02017964|EG000|Reported Event|All Eligible Patients (Combination Chemotherapy)|All eligible patients enrolled on the study
10784601|NCT01968785|BG000|Baseline|Radiation Dose 25 Gy|"• 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery."
10784602|NCT01968785|BG001|Baseline|Radiation Dose 50 Gy|"• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery."
10784603|NCT01968785|BG002|Baseline|Total|Total of all reporting groups
10784604|NCT01968785|FG000|Participant Flow|Radiation Dose 25 Gy|"• 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery."
10784605|NCT01968785|FG001|Participant Flow|Radiation Dose 50 Gy|"• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery."
10784606|NCT01968785|OG000|Outcome|Radiation Dose 25 Gy|"• 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery."
10784607|NCT01968785|OG001|Outcome|Radiation Dose 50 Gy|"• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery."
10784608|NCT01968785|EG000|Reported Event|Radiation Dose 25 Gy|"• 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 25 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery."
10784609|NCT01968785|EG001|Reported Event|Radiation Dose 50 Gy|"• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.~Radiation Dose 50 Gy: Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery."
10784610|NCT01956110|BG000|Baseline|FE 999049|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomised to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomisation. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784611|NCT01956110|BG001|Baseline|GONAL-F|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784612|NCT01956110|BG002|Baseline|Total|Total of all reporting groups
10784613|NCT01956110|FG000|Participant Flow|FE 999049|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomised to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomisation. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784614|NCT01956110|FG001|Participant Flow|GONAL-F|Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 international units (IU) and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784615|NCT01956110|OG000|Outcome|FE 999049|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomised to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomisation. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784616|NCT01956110|OG001|Outcome|GONAL-F|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784617|NCT01956110|OG001|Outcome|GONAL-F|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784618|NCT01956110|EG000|Reported Event|FE 999049|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomised to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomisation. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11194332|NCT02151851|OG000|Outcome|Placebo + Methotrexate (FAS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
10784619|NCT01956110|EG001|Reported Event|GONAL-F|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
10784620|NCT01648023|BG000|Baseline|Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo|"Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo~LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo"
10784621|NCT01648023|BG001|Baseline|Randomization to Gem-Cis or Gem-Carbo|"Gem-Cis or Gem-Carbo alone~Gem-Cis or Gem-Carbo"
10784622|NCT01648023|BG002|Baseline|Total|Total of all reporting groups
10784623|NCT01648023|FG000|Participant Flow|Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo|"Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo~LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo"
10784624|NCT01648023|FG001|Participant Flow|Randomization to Gem-Cis or Gem-Carbo|"Gem-Cis or Gem-Carbo alone~Gem-Cis or Gem-Carbo"
10784625|NCT01648023|OG000|Outcome|Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo|"Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo~LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo"
10784626|NCT01648023|OG001|Outcome|Randomization to Gem-Cis or Gem-Carbo|"Gem-Cis or Gem-Carbo alone~Gem-Cis or Gem-Carbo"
11381243|NCT03814590|OG011|Outcome|Medium Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11194333|NCT02151851|OG001|Outcome|Certolizumab Pegol + Methotrexate (FAS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
11381244|NCT03814590|OG012|Outcome|High Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381245|NCT03814590|OG013|Outcome|Placebo_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381246|NCT03814590|OG000|Outcome|Low Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381247|NCT03814590|OG001|Outcome|Medium Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381248|NCT03814590|OG002|Outcome|High Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381249|NCT03814590|OG003|Outcome|Low Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381250|NCT03814590|OG004|Outcome|Medium Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381251|NCT03814590|OG005|Outcome|High Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381252|NCT03814590|OG006|Outcome|Low Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381253|NCT03814590|OG007|Outcome|Medium Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381254|NCT03814590|OG008|Outcome|High Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381255|NCT03814590|OG009|Outcome|Placebo_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381256|NCT03814590|EG000|Reported Event|Low Dose_PLAIN_A Group|Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381257|NCT03814590|EG001|Reported Event|Medium Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381258|NCT03814590|EG002|Reported Event|High Dose_PLAIN_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381259|NCT03814590|EG003|Reported Event|Placebo_A Group|Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381260|NCT03814590|EG004|Reported Event|Low Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381261|NCT03814590|EG005|Reported Event|Medium Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381262|NCT03814590|EG006|Reported Event|High Dose_PLAIN_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381263|NCT03814590|EG007|Reported Event|Low Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381264|NCT03814590|EG008|Reported Event|Medium Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381265|NCT03814590|EG009|Reported Event|High Dose_AS01E_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381266|NCT03814590|EG010|Reported Event|Low Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
11381267|NCT03814590|EG011|Reported Event|Medium Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
10784627|NCT01648023|EG000|Reported Event|Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo|"Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo~LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo"
10784628|NCT01648023|EG001|Reported Event|Randomization to Gem-Cis or Gem-Carbo|"Gem-Cis or Gem-Carbo alone~Gem-Cis or Gem-Carbo"
11381268|NCT03814590|EG012|Reported Event|High Dose_AS01B_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
10964639|NCT00878553|OG003|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11194334|NCT02151851|EG000|Reported Event|Placebo + Methotrexate (SS)|"Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
11381269|NCT03814590|EG013|Reported Event|Placebo_B Group|Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
10784629|NCT01335581|BG000|Baseline|Laser Treatment|"Laser treatment added to microdermabrasion and topical lightening agent regimen~Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen"
10784630|NCT01335581|BG001|Baseline|Control Group|Microdermabrasion and topical lightening agent regimen
10784631|NCT01335581|BG002|Baseline|Total|Total of all reporting groups
10784632|NCT01335581|FG000|Participant Flow|Laser Treatment|"Laser treatment added to microdermabrasion and topical lightening agent regimen~Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen"
10784633|NCT01335581|FG001|Participant Flow|Control Group|Microdermabrasion and skin lightening regimen
10784634|NCT01335581|OG000|Outcome|Laser Treatment|"Laser treatment added to microdermabrasion and topical lightening agent regimen~Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen"
10784635|NCT01335581|OG001|Outcome|Control Group|Lightening cream and microdermabrasion only.
10784636|NCT01335581|EG000|Reported Event|Laser Treatment|"Laser treatment added to microdermabrasion and topical lightening agent regimen~Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen"
11194335|NCT02151851|EG001|Reported Event|Certolizumab Pegol + Methotrexate (SS)|"Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.~All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week)."
11194336|NCT02151877|BG000|Baseline|Nitric Oxide on CPB|"neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery~Inhaled Nitric Oxide: delivered inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
10784637|NCT01335581|EG001|Reported Event|Control Group|Microdermabrasion and topical lightening agent regimen only.
10784638|NCT01209923|BG000|Baseline|Body Composition Testing|"Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.~BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing."
10784639|NCT01209923|FG000|Participant Flow|Body Composition Testing|"Body composition tested using bioelectrical impedance (BC1) and the DEXA or hydrostatic weighing methods.~BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing."
10784640|NCT01209923|OG000|Outcome|Stayhealthy BC1 Bioelectric Impedance Analyzer|"Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.~BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing."
10784641|NCT01209923|OG001|Outcome|Reference Assessment|"Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.~Dual-Energy X-Ray Absoptiometry assessment of body fat for adults or hydrostatic weighing assessment of body fat for children"
10784642|NCT01209923|EG000|Reported Event|Body Composition Testing|"Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.~BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing."
10784643|NCT01083433|BG000|Baseline|Standard Diabetes Care|Patients will attend diabetes clinic as usual, once every 3 months.
10784644|NCT01083433|BG001|Baseline|Intensive Diabetes Clinic|"Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
11194337|NCT02151877|BG001|Baseline|Control|"neonates not receiving inhaled NO into the cardiopulmonary bypass~placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
10784645|NCT01083433|BG002|Baseline|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784646|NCT01083433|BG003|Baseline|Total|Total of all reporting groups
10784647|NCT01083433|FG000|Participant Flow|Standard Diabetes Care|Patients will attend diabetes clinic as usual, once every 3 months.
10784648|NCT01083433|FG001|Participant Flow|Intensive Diabetes Clinic|"Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
11194338|NCT02151877|BG002|Baseline|Total|Total of all reporting groups
11194339|NCT02151877|FG000|Participant Flow|Nitric Oxide on CPB|"neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery~Inhaled Nitric Oxide: delivered inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
11194340|NCT02151877|FG001|Participant Flow|Control|"neonates not receiving inhaled NO into the cardiopulmonary bypass~placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
10784649|NCT01083433|FG002|Participant Flow|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a CGM for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
10784650|NCT01083433|OG000|Outcome|Standard Diabetes Care|Patients will attend diabetes clinic as usual, once every 3 months.
10784651|NCT01083433|OG001|Outcome|Intensive Diabetes Clinic|"Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
10784652|NCT01083433|OG002|Outcome|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784653|NCT01083433|OG002|Outcome|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: Same as Intensive diabetes clinic group.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784654|NCT01083433|OG000|Outcome|Intensive Diabetes Clinic|"Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
10784655|NCT01083433|OG001|Outcome|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: Same as intensive diabetes clinic group.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784656|NCT01083433|OG002|Outcome|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: same as description for intensive diabetes clinic group.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784657|NCT01083433|EG000|Reported Event|Standard Diabetes Care|Patients will attend diabetes clinic as usual, once every 3 months.
10850635|NCT00303719|BG001|Baseline|Standard Risk Patients|Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder
10850636|NCT00303719|BG002|Baseline|Total|Total of all reporting groups
11194341|NCT02151877|OG000|Outcome|Nitric Oxide on CPB|"neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery~Inhaled Nitric Oxide: delivered inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
11194342|NCT02151877|OG001|Outcome|Control|"neonates not receiving inhaled NO into the cardiopulmonary bypass~placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery~12 patients were enrolled prospectively over 4 years period"
10784658|NCT01083433|EG001|Reported Event|Intensive Diabetes Clinic|"Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.~Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education."
10784659|NCT01083433|EG002|Reported Event|Intensive Diabetes Clinic Plus CGM|"Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.~Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.~Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months."
10784660|NCT00787176|BG000|Baseline|Group A|"An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.~Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol."
10784661|NCT00787176|BG001|Baseline|Group B|"An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.~Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784662|NCT00787176|BG002|Baseline|Group C|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.~Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol."
10784663|NCT00787176|BG003|Baseline|Group D|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.~Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784664|NCT00787176|BG004|Baseline|Total|Total of all reporting groups
10784665|NCT00787176|FG000|Participant Flow|Group A Full Oxytocin 1000 ml LR|"An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.~Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol."
10784666|NCT00787176|FG001|Participant Flow|Group B 1/2 Oxytocin 1000 ml LR|"An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.~Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784667|NCT00787176|FG002|Participant Flow|Group C Full Oxytocin No LR|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.~Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol."
10784668|NCT00787176|FG003|Participant Flow|Group D 1/2 Oxytocin no Additional LR|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.~Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784669|NCT00787176|OG000|Outcome|Group A|"An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.~Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol."
10784670|NCT00787176|OG001|Outcome|Group B|"An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.~Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784671|NCT00787176|OG002|Outcome|Group C|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.~Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol."
10850637|NCT00303719|FG000|Participant Flow|High Risk Patients|Patients with refractory leukemia or MDS
10850638|NCT00303719|FG001|Participant Flow|Standard Risk Patients|Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder
10850639|NCT00303719|OG000|Outcome|High Risk Patients|Patients with refractory leukemia or MDS
10784672|NCT00787176|OG003|Outcome|Group D|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.~Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784673|NCT00787176|OG004|Outcome|Group Sum|Sum of the four groups
10784674|NCT00787176|EG000|Reported Event|Group A|"An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.~Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol."
10784675|NCT00787176|EG001|Reported Event|Group B|"An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.~Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10784676|NCT00787176|EG002|Reported Event|Group C|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.~Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol."
10784677|NCT00787176|EG003|Reported Event|Group D|"The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.~Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement."
10801901|NCT02913222|OG000|Outcome|Movement Pattern Training (MPT)|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface.~Rehabilitation: Comparison of two rehabilitation approaches"
10801902|NCT02913222|OG001|Outcome|Standard Rehabilitation|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load.~Rehabilitation: Comparison of two rehabilitation approaches"
10801903|NCT02913222|EG000|Reported Event|Movement Pattern Training (MPT)|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface.~Rehabilitation: Comparison of two rehabilitation approaches"
10801904|NCT02913222|EG001|Reported Event|Standard Rehabilitation|"Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load.~Rehabilitation: Comparison of two rehabilitation approaches"
10801905|NCT02734433|BG000|Baseline|Cohort 1 - 600 mg/Day|Participants who received pexidartinib 600 mg/day (200 mg in the morning and 400 mg in the evening).
11194343|NCT02151877|OG000|Outcome|Nitric Oxide on CPB|"neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery~Inhaled Nitric Oxide: delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery"
11194344|NCT02151877|OG001|Outcome|Control|"neonates not receiving inhaled NO into the cardiopulmonary bypass~placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery"
10801906|NCT02734433|BG001|Baseline|Cohort 2 - 1000 mg/Day|Participants who received pexidartinib 1000 mg/day (400 mg in the morning and 600 mg in the evening) for the first 2 weeks. Thereafter, the dose was reduced to 800 mg/day (400 mg in the morning and 400 mg in the evening).
10801907|NCT02734433|BG002|Baseline|Total|Total of all reporting groups
10801908|NCT02734433|FG000|Participant Flow|Cohort 1 - 600 mg/Day|Participants who received pexidartinib 600 mg/day (200 mg in the morning and 400 mg in the evening).
11194345|NCT02151877|EG000|Reported Event|Nitric Oxide on CPB|Group that received nitric oxide in CPB
11194346|NCT02151877|EG001|Reported Event|Control|Group that did not receive nitric oxide in CPB
11194347|NCT02151903|BG000|Baseline|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
10784678|NCT00352534|BG000|Baseline|Stage I or II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.
10784679|NCT00352534|BG001|Baseline|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
10784680|NCT00352534|BG002|Baseline|Total|Total of all reporting groups
10784681|NCT00352534|FG000|Participant Flow|Stage I/II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment
10784682|NCT00352534|FG001|Participant Flow|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
10784683|NCT00352534|FG002|Participant Flow|Very Low Risk Disease|Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.
10784684|NCT00352534|FG003|Participant Flow|Low Risk, Stage I or II, no LOH|Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).
10784685|NCT00352534|FG004|Participant Flow|Standard Risk, Stage I or II With LOH|Treatment arm. Standard Risk, Stage I or II with LOH.
10784686|NCT00352534|FG005|Participant Flow|Standard Risk, Stage III|Treatment arm. Standard Risk, Stage III.
10784687|NCT00352534|FG006|Participant Flow|High Risk|Treatment arm. High risk.
11194348|NCT02151903|BG001|Baseline|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
11194349|NCT02151903|BG002|Baseline|Total|Total of all reporting groups
10784688|NCT00352534|OG000|Outcome|Very Low Risk|Very Low Risk
10784689|NCT00352534|OG001|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
10784690|NCT00352534|OG002|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
10784691|NCT00352534|EG000|Reported Event|Very Low Risk Disease|Nephrectomy and Re-evaluation
10784692|NCT00352534|EG001|Reported Event|Low Risk, Stage I or II, no LOH|Low risk, stage I or II, no loss of heterozygosity (LOH).
11194350|NCT02151903|FG000|Participant Flow|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
11194351|NCT02151903|FG001|Participant Flow|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
10784693|NCT00352534|EG002|Reported Event|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with loss of heterozygosity (LOH).
10784694|NCT00352534|EG003|Reported Event|Standard Risk, Stage III|Nephrectomy/Biopsy, Chemotherapy
10784695|NCT00352534|EG004|Reported Event|High Risk|High risk.
10784696|NCT00033293|BG000|Baseline|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
10784697|NCT00033293|BG001|Baseline|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
10784698|NCT00033293|BG002|Baseline|Total|Total of all reporting groups
10784699|NCT00033293|FG000|Participant Flow|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
10784700|NCT00033293|FG001|Participant Flow|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
10784701|NCT00033293|OG000|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
10784702|NCT00033293|OG001|Outcome|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
10784703|NCT00033293|OG000|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
10784704|NCT00033293|OG001|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
10784705|NCT00033293|EG000|Reported Event|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
10784706|NCT00033293|EG001|Reported Event|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
10801909|NCT02734433|FG001|Participant Flow|Cohort 2 - 1000 mg/Day|Participants who received pexidartinib 1000 mg/day (400 mg in the morning and 600 mg in the evening) for the first 2 weeks. Thereafter, the dose was reduced to 800 mg/day (400 mg in the morning and 400 mg in the evening).
10801910|NCT02734433|OG000|Outcome|Cohort 1 - 600 mg/Day|Participants who received pexidartinib 600 mg/day (200 mg in the morning and 400 mg in the evening).
10801911|NCT02734433|OG001|Outcome|Cohort 2 - 1000 mg/Day|Participants who received pexidartinib 1000 mg/day (400 mg in the morning and 600 mg in the evening) for the first 2 weeks. Thereafter, the dose was reduced to 800 mg/day (400 mg in the morning and 400 mg in the evening).
10801912|NCT02734433|EG000|Reported Event|Cohort 1 - 600 mg/Day|Participants who received pexidartinib 600 mg/day (200 mg in the morning and 400 mg in the evening).
10801913|NCT02734433|EG001|Reported Event|Cohort 2 - 1000 mg/Day|Participants who received pexidartinib 1000 mg/day (400 mg in the morning and 600 mg in the evening) for the first 2 weeks. Thereafter, the dose was reduced to 800 mg/day (400 mg in the morning and 400 mg in the evening).
10801914|NCT02474927|BG000|Baseline|Carfilzomib Treatment Arm|"Carfilzomib will be administered at a dose of 20 mg/m2 on two consecutive days, each week for three weeks (Days 1 2, 8, 9, 15, and 16) to constitute one therapeutic cycle. Carfilzomib may be administered for 1-2 complete cycles in the study.~Carfilzomib: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)"
10801915|NCT02474927|FG000|Participant Flow|Carfilzomib Treatment Arm|"Carfilzomib will be administered at a dose of 20 mg/m2 on two consecutive days, each week for three weeks (Days 1 2, 8, 9, 15, and 16) to constitute one therapeutic cycle. Carfilzomib may be administered for 1-2 complete cycles in the study.~Carfilzomib: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)"
10801916|NCT02474927|OG000|Outcome|Carfilzomib Treatment Arm|"Carfilzomib will be administered at a dose of 20 mg/m2 on two consecutive days, each week for three weeks (Days 1 2, 8, 9, 15, and 16) to constitute one therapeutic cycle. Carfilzomib may be administered for 1-2 complete cycles in the study.~Carfilzomib: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)"
10801917|NCT02474927|EG000|Reported Event|Carfilzomib Treatment Arm|"Carfilzomib will be administered at a dose of 20 mg/m2 on two consecutive days, each week for three weeks (Days 1 2, 8, 9, 15, and 16) to constitute one therapeutic cycle. Carfilzomib may be administered for 1-2 complete cycles in the study.~Carfilzomib: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)"
10801918|NCT02145507|BG000|Baseline|Arm 1: Room Temperature Storage/Filtration|"In vitro whole blood storage, leukoreduction and processing of donated whole blood.~SOLX: SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801919|NCT02145507|BG001|Baseline|Arm 2 : Cold Storage/Filtration|"In vitro analysis of whole blood following refrigerated storage for > 66 hours prior to leukoreduction and subsequent processing of packed red blood cells.~SOLX: SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
11381270|NCT03811574|BG000|Baseline|Semaglutide 1.7 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381271|NCT03811574|BG001|Baseline|Semaglutide 2.4 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381272|NCT03811574|BG002|Baseline|Placebo|Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.
11381273|NCT03811574|BG003|Baseline|Total|Total of all reporting groups
11381274|NCT03811574|FG000|Participant Flow|Semaglutide 1.7 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 milliliter (mL) cartridge containing semaglutide 1.0 milligram per milliliter (mg/mL) or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381275|NCT03811574|FG001|Participant Flow|Semaglutide 2.4 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381276|NCT03811574|FG002|Participant Flow|Placebo|Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.
11381277|NCT03811574|OG000|Outcome|Semaglutide 1.7 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381278|NCT03811574|OG001|Outcome|Semaglutide 2.4 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381279|NCT03811574|OG002|Outcome|Placebo|Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.
11381280|NCT03811574|EG000|Reported Event|Semaglutide 1.7 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381281|NCT03811574|EG001|Reported Event|Semaglutide 2.4 mg|Participants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.
11381282|NCT03811574|EG002|Reported Event|Placebo|Participants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.
11381283|NCT03800420|BG000|Baseline|BBT-401-1S|"BBT-401-1S, Oral capsule, QD~BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks."
11381284|NCT03800420|BG001|Baseline|Placebo|"Placebo, Oral capsule, QD~Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks."
11381285|NCT03800420|BG002|Baseline|Total|Total of all reporting groups
11381286|NCT03800420|FG000|Participant Flow|BBT-401-1S|"BBT-401-1S, Oral capsule, QD~BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks."
10801920|NCT02145507|BG002|Baseline|Total|Total of all reporting groups
11194352|NCT02151903|OG000|Outcome|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
11194353|NCT02151903|OG001|Outcome|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
10784707|NCT04497415|BG000|Baseline|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~Video-Based intervention: Three minutes video of a nurse that shares her personal story"
10784708|NCT04497415|BG001|Baseline|Assessment Only|Control
10784709|NCT04497415|BG002|Baseline|Total|Total of all reporting groups
10784710|NCT04497415|FG000|Participant Flow|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~Video-Based intervention: Three minutes video of a nurse that shares her personal story"
10784711|NCT04497415|FG001|Participant Flow|Assessment Only|Control
10784712|NCT04497415|OG000|Outcome|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~Video-Based intervention: Three minutes video of a nurse that shares her personal story"
10784713|NCT04497415|OG001|Outcome|Assessment Only|Control
10784714|NCT04497415|EG000|Reported Event|Video-based Intervention|"A brief video about coping with COVID-19 stress presented to the participants~Video-Based intervention: Three minutes video of a nurse that shares her personal story"
11194354|NCT02151903|EG000|Reported Event|DI-Leu16-IL2 1.0 mg/m^2|Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
10784715|NCT04497415|EG001|Reported Event|Assessment Only|Control
10784716|NCT04231396|BG000|Baseline|HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training|"*The COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study caused an imbalance of subgroup numbers for comparisons, therefore, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group.~Study participants were seen for 12 weeks and used the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher conducted 12 weekly visits where the following was done:~First 6 weeks:~• Administer partial BKB-SIN test~Final 6 weeks:~Administer partial BKB-SIN test~Conduct a comprehension test.~Address any usability issues the participant brings up.~Review and set new weekly goals Final session: Conduct Final Usability survey"
10784717|NCT04231396|FG000|Participant Flow|HA and CI Users Using Audiobooks for Hearing Loss App as Auditory Training|"*The COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study caused an imbalance of subgroup numbers for comparisons, therefore, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group.~Study participants were seen for 12 weeks and used the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher conducted 12 weekly visits where the following was done:~First 6 weeks:~• Administer partial BKB-SIN test~Final 6 weeks:~Administer partial BKB-SIN test~Conduct a comprehension test.~Address any usability issues the participant brings up.~Review and set new weekly goals Final session: Conduct Final Usability survey"
10784718|NCT04231396|OG000|Outcome|HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training|"Study participants will use the Audiobooks for HL App for 12 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly visits where the following will be done:~First 6 weeks:~• Partial BKB-SIN will be administered~Final 6 weeks:~Partial BKB-SIN will be administered~Conduct a comprehension test.~Address any usability issues the participant brings up.~Review and set new weekly goals Final session: Conduct Final Usability survey of the App"
10784719|NCT04231396|OG000|Outcome|HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training|"study participants will use the Audiobooks for HL App for 12 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly visits where the following will be done:~First 6 weeks:~• Partial BKB-SIN will be administered~Final 6 weeks:~Partial BKB-SIN will be administered~Conduct a comprehension test.~Address any usability issues the participant brings up.~Review and set new weekly goals Final session: Conduct Final Usability survey"
10784720|NCT04231396|EG000|Reported Event|HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training|"*The COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study caused an imbalance of subgroup numbers for comparisons, therefore, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group.~Study participants were seen for 12 weeks and used the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher conducted 12 weekly visits where the following was done:~First 6 weeks:~• Administer partial BKB-SIN test~Final 6 weeks:~Administer partial BKB-SIN test~Conduct a comprehension test.~Address any usability issues the participant brings up.~Review and set new weekly goals Final session: Conduct Final Usability survey"
10784721|NCT04118348|BG000|Baseline|Passive Control|Will consist of no alerts and will serve to examine lipid panel screening rates given the current standard of care. After 6 months, providers in this (and other conditions) will receive the alert(s) with the best demonstrated success in increasing screening rates.
10784722|NCT04118348|BG001|Baseline|Best Practice Alert (BPA-only)|Will consist of a BPA that fires for providers during a visit with an eligible 9-11 year-old patient. This is an active opt-in alert wherein the provider must respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test. The BPA will include a recommendation to administer the screen in combination with existing scheduled bloodwork.
10784723|NCT04118348|BG002|Baseline|Health Maintenance Topic (HMT-only)|Will consist of an HMT in Epic that is present for providers at their visit with an eligible patient. The HMT will be highlighted for enhanced visibility, until or unless action is taken.
11194355|NCT02151903|EG001|Reported Event|DI-Leu16-IL2 2.0 mg/m^2|Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects.
11381287|NCT03800420|FG001|Participant Flow|Placebo|"Placebo, Oral capsule, QD~Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks."
10784724|NCT04118348|BG003|Baseline|BPA+HMT|Will consist of both the BPA and HMT presented simultaneously in Epic.
10784725|NCT04118348|BG004|Baseline|Total|Total of all reporting groups
10784726|NCT04118348|FG000|Participant Flow|Passive Control|Will consist of no alerts and will serve to examine lipid panel screening rates given the current standard of care. After 6 months, providers in this (and other conditions) will receive the alert(s) with the best demonstrated success in increasing screening rates.
10784727|NCT04118348|FG001|Participant Flow|Best Practice Alert (BPA-only)|"Will consist of a BPA that fires for providers during a visit with an eligible 9-11 year-old patient. This is an active opt-in alert wherein the provider must respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test. The BPA will include a recommendation to administer the screen in combination with existing scheduled bloodwork.~When referring to study arms, BPA refers to participants who triggered BPAs only."
10784728|NCT04118348|FG002|Participant Flow|Health Maintenance Topic (HMT-only)|"Will consist of an HMT in Epic that is present for providers at their visit with an eligible patient. The HMT will be highlighted for enhanced visibility, until or unless action is taken.~When referring to study arms, HMT refers to participants who triggered HMTs only."
10784729|NCT04118348|FG003|Participant Flow|BPA+HMT|"Will consist of both the BPA and HMT presented simultaneously in Epic. This is a separate group of participants compared to the BPA-only and HMT-only arms.~When referring to study arms, BPA+HMT refers to participants who triggered a combination of BPA and HMT."
10784730|NCT04118348|OG000|Outcome|Passive Control|Will consist of no alerts and will serve to examine lipid panel screening rates given the current standard of care. After 6 months, providers in this (and other conditions) will receive the alert(s) with the best demonstrated success in increasing screening rates.
10784731|NCT04118348|OG001|Outcome|Best Practice Alert (BPA-only)|Will consist of a BPA that fires for providers during a visit with an eligible 9-11 year-old patient. This is an active opt-in alert wherein the provider must respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test. The BPA will include a recommendation to administer the screen in combination with existing scheduled bloodwork.
10784732|NCT04118348|OG002|Outcome|Health Maintenance Topic (HMT-only)|Will consist of an HMT in Epic that is present for providers at their visit with an eligible patient. The HMT will be highlighted for enhanced visibility, until or unless action is taken.
10784733|NCT04118348|OG003|Outcome|BPA+HMT|Will consist of both the BPA and HMT presented simultaneously in Epic.
10784734|NCT04118348|EG000|Reported Event|Passive Control|Will consist of no alerts and will serve to examine lipid panel screening rates given the current standard of care. After 6 months, providers in this (and other conditions) will receive the alert(s) with the best demonstrated success in increasing screening rates.
10784735|NCT04118348|EG001|Reported Event|Best Practice Alert (BPA-only)|Will consist of a BPA that fires for providers during a visit with an eligible 9-11 year-old patient. This is an active opt-in alert wherein the provider must respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test. The BPA will include a recommendation to administer the screen in combination with existing scheduled bloodwork.
10784736|NCT04118348|EG002|Reported Event|Health Maintenance Topic (HMT-only)|Will consist of an HMT in Epic that is present for providers at their visit with an eligible patient. The HMT will be highlighted for enhanced visibility, until or unless action is taken.
10784737|NCT04118348|EG003|Reported Event|BPA+HMT|Will consist of both the BPA and HMT presented simultaneously in Epic.
10801921|NCT02145507|FG000|Participant Flow|Arm 1: Room Temperature|"Whole blood donation for room temperature storage of IP and CP.~SOLX (Investigational Product): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801922|NCT02145507|FG001|Participant Flow|Arm 2: Cold Storage|"Whole blood donation for cold storage for IP and CP.~SOLX (Investigational Product): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit."
11381288|NCT03800420|OG000|Outcome|BBT-401-1S First and Then Placebo|"Total 16 weeks~First 12 weeks, BBT-401-1S, Oral capsule, QD. Followed by 4 weeks Placebo, Oral capsule, QD."
10801923|NCT02145507|OG000|Outcome|Arm 1: SOLX Room Temperature Storage/Filtration|"SOLX (Investigational Product)~SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit"
10801924|NCT02145507|OG001|Outcome|Arm 2 : SOLX Cold Storage|"SOLX (Investigational Product)~SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801925|NCT02145507|OG002|Outcome|Arm 1: Control Room Temperature Storage/Filtration|"AS-3 (Control)~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit"
10801926|NCT02145507|OG003|Outcome|Arm 2: Control Cold Storage|"AS-3 (Control)~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit"
10801927|NCT02145507|OG000|Outcome|Arm 1: SOLX Room Temperature Storage/Filtration|"SOLX (Investigational Product)~SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801928|NCT02145507|EG000|Reported Event|Arm 1: SOLX Room Temperature Storage/Filtration|"SOLX (Investigational Product)~SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801929|NCT02145507|EG001|Reported Event|Arm 2 : SOLX Cold Storage|"SOLX (Investigational Product)~SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit."
10801930|NCT02145507|EG002|Reported Event|Arm 1: Control Room Temperature Storage/Filtration|"AS-3 (Control)~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit"
10801931|NCT02145507|EG003|Reported Event|Arm 2: Control Cold Storage|"AS-3 (Control)~AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit"
11381289|NCT03800420|OG001|Outcome|Placebo First and Then BBT-401-1S|Total 16 weeks First Placebo, 8 weeks Oral capsule, QD Followed by 8 weeks BBT-401-1S, Oral capsule, QD
10784738|NCT04975321|BG000|Baseline|Nu Smile Zirconia Crown|"Anterior primary teeth which received a NuSmile zirconia crown as a final restoration~Nu Smile Zirconia crown: Placement of an anterior primary crown restoration"
10784739|NCT04975321|BG001|Baseline|Nu Smile Pre Veneered Crown|"Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration~Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration"
10784740|NCT04975321|BG002|Baseline|Composite Strip Crown|"Anterior primary teeth which received a composite strip crown as a final restoration~Composite strip crown: Placement of an anterior primary crown restoration"
10784741|NCT04975321|BG003|Baseline|Total|Total of all reporting groups
10784742|NCT04975321|FG000|Participant Flow|Nu Smile Zirconia Crown|"Anterior primary teeth which received a NuSmile zirconia crown as a final restoration~Nu Smile Zirconia crown: Placement of an anterior primary crown restoration"
10784743|NCT04975321|FG001|Participant Flow|Nu Smile Pre Veneered Crown|"Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration~Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration"
10784744|NCT04975321|FG002|Participant Flow|Composite Strip Crown|"Anterior primary teeth which received a composite strip crown as a final restoration~Composite strip crown: Placement of an anterior primary crown restoration"
10784745|NCT04975321|OG000|Outcome|Nu Smile Zirconia Crown|"Anterior primary teeth which received a NuSmile zirconia crown as a final restoration~Nu Smile Zirconia crown: Placement of an anterior primary crown restoration"
10784746|NCT04975321|OG001|Outcome|Nu Smile Pre Veneered Crown|"Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration~Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration"
10784747|NCT04975321|OG002|Outcome|Composite Strip Crown|"Anterior primary teeth which received a composite strip crown as a final restoration~Composite strip crown: Placement of an anterior primary crown restoration"
10784748|NCT04975321|EG000|Reported Event|Nu Smile Zirconia Crown|"Anterior primary teeth which received a NuSmile zirconia crown as a final restoration~Nu Smile Zirconia crown: Placement of an anterior primary crown restoration"
10784749|NCT04975321|EG001|Reported Event|Nu Smile Pre Veneered Crown|"Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration~Nu Smile Pre Veneered crown: Placement of an anterior primary crown restoration"
10784750|NCT04975321|EG002|Reported Event|Composite Strip Crown|"Anterior primary teeth which received a composite strip crown as a final restoration~Composite strip crown: Placement of an anterior primary crown restoration"
11381290|NCT03800420|OG000|Outcome|BBT-401-1S|"BBT-401-1S, Oral capsule, QD~BBT-401-1S first and then Placebo: Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks."
10784751|NCT04594759|BG000|Baseline|Treatment Group|Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
10784752|NCT04594759|FG000|Participant Flow|Treatment Group|Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
10784753|NCT04594759|OG000|Outcome|Treatment Group|Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
10784754|NCT04594759|EG000|Reported Event|Treatment Group|Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
10784755|NCT04463069|BG000|Baseline|Intervention Group|"Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.~Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months."
10784756|NCT04463069|BG001|Baseline|Control Group|Participants in the control group received no intervention in the study time period.
10784757|NCT04463069|BG002|Baseline|Total|Total of all reporting groups
10784758|NCT04463069|FG000|Participant Flow|Intervention Group|"Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.~Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months."
10784759|NCT04463069|FG001|Participant Flow|Control Group|Participants in the control group received no intervention in the study time period.
10784760|NCT04463069|OG000|Outcome|Intervention Group|"Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.~Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months."
10784761|NCT04463069|OG001|Outcome|Control Group|Participants in the control group received no intervention in the study time period.
11381291|NCT03800420|OG001|Outcome|Placebo|"Placebo, Oral capsule, QD~Placebo first and then BBT-401-1S: Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks."
11194356|NCT02151994|BG000|Baseline|Single Ascending Dose (SAD)|This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomised design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
11194357|NCT02151994|BG001|Baseline|Multiple Ascending Dose (MAD)|This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
10784762|NCT04463069|EG000|Reported Event|Intervention Group|"Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.~Adapted physical activity: This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months."
10784763|NCT04463069|EG001|Reported Event|Control Group|Participants in the control group received no intervention in the study time period.
10784764|NCT04250337|BG000|Baseline|Placebo + Topical Corticosteroid|"Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14.~TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response."
10784765|NCT04250337|BG001|Baseline|Lebrikizumab + Topical Corticosteroid|"500 mg Lebrikizumab (2 x 250 mg) SC injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14.~TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response"
10784766|NCT04250337|BG002|Baseline|Total|Total of all reporting groups
10784767|NCT04250337|FG000|Participant Flow|Placebo + Topical Corticosteroid|"Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14.~Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response"
10784768|NCT04250337|FG001|Participant Flow|Lebrikizumab + Topical Corticosteroid|"500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14.~TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response."
10784769|NCT04250337|OG000|Outcome|Placebo +Topical Corticosteroid|Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
10784770|NCT04250337|OG001|Outcome|Lebrikizumab + Topical Corticosteroid|"500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14.~TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response."
10784771|NCT04250337|OG000|Outcome|Placebo +Topical Corticosteroid|Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
11194358|NCT02151994|BG002|Baseline|Food Interaction (Food Effect, FE) Analysis|This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.
11194359|NCT02151994|BG003|Baseline|Total|Total of all reporting groups
11194360|NCT02151994|FG000|Participant Flow|Placebo|Placebo : visually matching active medication
11381292|NCT03800420|OG000|Outcome|BBT-401-1S|"BBT-401-1S, Oral capsule, QD~BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks."
10784772|NCT04250337|EG000|Reported Event|Placebo +Topical Corticosteroid|Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
10784773|NCT04250337|EG001|Reported Event|Lebrikizumab + Topical Corticosteroid|500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
11194361|NCT02151994|FG001|Participant Flow|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
11194362|NCT02151994|FG002|Participant Flow|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
11381293|NCT03800420|OG001|Outcome|Placebo|"Placebo, Oral capsule, QD~Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks."
11381294|NCT03800420|EG000|Reported Event|BBT-401-1S|"BBT-401-1S, Oral capsule, QD~BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks."
11381295|NCT03800420|EG001|Reported Event|Placebo|"Placebo, Oral capsule, QD~Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks."
11381296|NCT03759184|BG000|Baseline|Arm 1 - Dose Escalation - Dose Level 1|"Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.~Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.~Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle."
11381297|NCT03759184|FG000|Participant Flow|Arm 1 - Dose Escalation - Dose Level 1|"Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.~Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.~Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle."
11381298|NCT03759184|OG000|Outcome|Arm 1 - Dose Escalation - Dose Level 1|"Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.~Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.~Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle."
11381299|NCT03759184|EG000|Reported Event|Arm 1 - Dose Escalation - Dose Level 1|"Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.~Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.~Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle."
11381300|NCT03747640|BG000|Baseline|tDCS With Mindfulness-based Meditation|"Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation~Self Transcranial Direct Current Stimulation (tDCS): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.~mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player."
11381301|NCT03747640|BG001|Baseline|Sham tDCS With Sham Meditation|"Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation~Sham Self Transcranial Direct Current Stimulation (tDCS): For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.~sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention."
11381302|NCT03747640|BG002|Baseline|Total|Total of all reporting groups
11381303|NCT03747640|FG000|Participant Flow|tDCS With Mindfulness-based Meditation|"Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation~Self Transcranial Direct Current Stimulation (tDCS): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.~mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player."
11381304|NCT03747640|FG001|Participant Flow|Sham tDCS With Sham Meditation|"Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation~Sham Self Transcranial Direct Current Stimulation (tDCS): For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.~sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention."
11381305|NCT03747640|OG000|Outcome|tDCS With Mindfulness-based Meditation|"Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation~Self Transcranial Direct Current Stimulation (tDCS): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.~mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player."
11241005|NCT02483975|BG000|Baseline|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11381306|NCT03747640|OG001|Outcome|Sham tDCS With Sham Meditation|"Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation~Sham Self Transcranial Direct Current Stimulation (tDCS): For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.~sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention."
11381307|NCT03747640|OG000|Outcome|tDCS With Mindfulness-based Meditation|"Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation Self Transcranial Direct Current Stimulation (tDCS): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.~mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player."
11381308|NCT03747640|OG001|Outcome|Sham tDCS With Sham Meditation|"Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation Sham Self Transcranial Direct Current Stimulation (tDCS): For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.~sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention."
11381309|NCT03747640|EG000|Reported Event|tDCS With Mindfulness-based Meditation|"Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation~Self Transcranial Direct Current Stimulation (tDCS): tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.~mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player."
11381310|NCT03747640|EG001|Reported Event|Sham tDCS With Sham Meditation|"Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation~Sham Self Transcranial Direct Current Stimulation (tDCS): For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.~sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention."
11381311|NCT03727750|BG000|Baseline|Gemtuzumab Ozogamicin (GO)|Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.
11381312|NCT03727750|FG000|Participant Flow|Gemtuzumab Ozogamicin (GO)|Participants with confirmed diagnosis of refractory or relapsed cluster of differentiation (CD33)- positive Acute Myeloid Leukemia (AML) aged greater than or equal to (>=) 18 years received three doses of Gemtuzumab Ozogamicin, 3 milligram per meter square (mg/m^2) as intravenous (IV) infusion on Days 1, 4 and 7 of Cycle 1 and 2.
11381313|NCT03727750|OG000|Outcome|Gemtuzumab Ozogamicin (GO)|Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.
11381314|NCT03727750|EG000|Reported Event|Gemtuzumab Ozogamicin (GO)|Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.
11381315|NCT03715829|BG000|Baseline|PF-06651600 200 mg - 50 mg QD|Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381316|NCT03715829|BG001|Baseline|PF-06651600 100 mg - 50 mg QD|Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381317|NCT03715829|BG002|Baseline|PF-06651600 50 mg QD|Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
11381318|NCT03715829|BG003|Baseline|PF-06651600 30 mg QD|Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
11381319|NCT03715829|BG004|Baseline|PF-06651600 10 mg QD|Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
11381320|NCT03715829|BG005|Baseline|Placebo|Participants were randomized to receive placebo for 24 weeks.
11381321|NCT03715829|BG006|Baseline|Total|Total of all reporting groups
11381322|NCT03715829|FG000|Participant Flow|PF-06651600 200 mg - 50 mg QD|Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381323|NCT03715829|FG001|Participant Flow|PF-06651600 100 mg - 50 mg QD|Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381324|NCT03715829|FG002|Participant Flow|PF-06651600 50 mg QD|Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
11381325|NCT03715829|FG003|Participant Flow|PF-06651600 30 mg QD|Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
11381326|NCT03715829|FG004|Participant Flow|PF-06651600 10 mg QD|Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
11381327|NCT03715829|FG005|Participant Flow|Placebo|Participants were randomized to receive placebo for 24 weeks.
11381328|NCT03715829|FG006|Participant Flow|Extension (EXT) PF-06700841 60 mg - 30 mg QD|After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
10784774|NCT04126733|BG000|Baseline|Regorafenib Plus Nivolumab|"Regorafenib was administrated 2x40 mg once daily (q.d.) on cycle 1 and up to 3x40 mg q.d. from cycle 2 onward for 3 weeks of each 28 days treatment cycle (21 days on/7 days off).~Nivolumab was administrated 480 mg on day 1 of each 28 days treatment cycle (Q4W)."
10784775|NCT04126733|FG000|Participant Flow|Regorafenib Plus Nivolumab|"Regorafenib was administrated 2x40 mg once daily (q.d.) on cycle 1 and up to 3x40 mg q.d. from cycle 2 onward for 3 weeks of each 28 days treatment cycle (21 days on/7 days off).~Nivolumab was administrated 480 mg on day 1 of each 28 days treatment cycle (Q4W)."
10784776|NCT04126733|OG000|Outcome|Regorafenib Plus Nivolumab|"Regorafenib was administrated 2x40 mg once daily (q.d.) on cycle 1 and up to 3x40 mg q.d. from cycle 2 onward for 3 weeks of each 28 days treatment cycle (21 days on/7 days off).~Nivolumab was administrated 480 mg on day 1 of each 28 days treatment cycle (Q4W)."
10784777|NCT04126733|EG000|Reported Event|Regorafenib Plus Nivolumab|Regorafenib was administrated 2x40mg q.d. (cycle 1) then up to 3x40mg q.d. (from cycle 2 onward) for 3 weeks of each 28 days treatment cycle. Nivolumab was administrated 480mg on day 1 of each 28 days treatment cycle.
10801932|NCT02120469|BG000|Baseline|Dose Level B1|"everolimus 5mg; eribulin 1.1mg/m^2; 10 mL dexamethasone mouthwash~Patients receive 5mg everolimus PO QD on days 1-21 and 1.1 mg/m^2 eribulin mesylate IV on days 1 and 8 and 10 mL of alcohol-free dexamethasone 0.5 mg/5 mL oral solution, swish for 2 min and spit, 4 times daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801933|NCT02120469|BG001|Baseline|Dose Level A1|"5mg everolimus; 1.4 mg/m^2 eribulin mesylate~Patients receive 5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801934|NCT02120469|BG002|Baseline|Dose Level A2|"7.5mg everolimus; 1.4 mg/m^2 eribulin mesylate~Patients receive 7.5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801935|NCT02120469|BG003|Baseline|Total|Total of all reporting groups
10801936|NCT02120469|FG000|Participant Flow|Dose Level B1|"everolimus 5mg; eribulin 1.1mg/m^2; 10 mL dexamethasone mouthwash~Patients receive 5mg everolimus PO QD on days 1-21 and 1.1 mg/m^2 eribulin mesylate IV on days 1 and 8 and 10 mL of alcohol-free dexamethasone 0.5 mg/5 mL oral solution, swish for 2 min and spit, 4 times daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801937|NCT02120469|FG001|Participant Flow|Dose Level A1|"everolimus 5mg; eribulin 1.4mg/m^2~Patients receive 5 mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801938|NCT02120469|FG002|Participant Flow|Dose Level A2|"everolimus 7.5mg; eribulin 1.4mg/m^2~Patients receive 7.5 mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801939|NCT02120469|OG000|Outcome|Dose Level B1|"everolimus 5mg; eribulin 1.1mg/m^2; 10 mL dexamethasone mouthwash~Patients receive 5mg everolimus PO QD on days 1-21 and 1.1 mg/m^2 eribulin mesylate IV on days 1 and 8 and 10 mL of alcohol-free dexamethasone 0.5 mg/5 mL oral solution, swish for 2 min and spit, 4 times daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801940|NCT02120469|OG001|Outcome|Dose Level A1|"everolimus 5mg; eribulin 1.4mg/m^2~Patients receive 5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801941|NCT02120469|OG002|Outcome|Dose Level A2|"everolimus 7.5mg; eribulin 1.4mg/m^2~Patients receive 7.5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11241006|NCT02483975|BG001|Baseline|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10801942|NCT02120469|OG001|Outcome|Dose Level A1|"everolimus 5mg; eribulin 1.4mg/m^2~Patients receive 5 mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801943|NCT02120469|OG002|Outcome|Dose Level A2|"everolimus 7.5mg; eribulin 1.4mg/m^2~Patients receive 7.5 mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801944|NCT02120469|EG000|Reported Event|Dose Level B1|"everolimus 5mg; eribulin 1.1mg/m^2; 10 mL dexamethasone mouthwash~Patients receive 5mg everolimus PO QD on days 1-21 and 1.1 mg/m^2 eribulin mesylate IV on days 1 and 8 and 10 mL of alcohol-free dexamethasone 0.5 mg/5 mL oral solution, swish for 2 min and spit, 4 times daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801945|NCT02120469|EG001|Reported Event|Dose Level A1|"everolimus 5mg; eribulin 1.4mg/m^2~Patients receive 5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801946|NCT02120469|EG002|Reported Event|Dose Level A2|"everolimus 7.5mg; eribulin 1.4mg/m^2~Patients receive 7.5mg everolimus PO QD on days 1-21 and 1.4 mg/m^2 eribulin mesylate IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
10801947|NCT02048722|BG000|Baseline|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO"
10801948|NCT02048722|FG000|Participant Flow|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO"
10801949|NCT02048722|OG000|Outcome|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO"
10784778|NCT03909178|BG000|Baseline|SPT Group: Surgery and Physical Therapy|Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
10784779|NCT03909178|BG001|Baseline|PTA Group: Physical Therapy Alone|"PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks~1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients."
10784780|NCT03909178|BG002|Baseline|Total|Total of all reporting groups
10784781|NCT03909178|FG000|Participant Flow|Hip Arthroscopy Surgery With Acetabular Labral Repair|"Hip Arthroscopy Surgery with Acetabular Labral Repair~Hip Arthroscopy Surgery with Acetabular Labral Repair: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.~Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair.~Any subject randomized to surgery will be seen by Dr. Martin to be consented separately for the arthroscopic procedure, which is standard of care. Those receiving surgical management will be scheduled for the post-operative physical therapy protocol within 2 weeks of their operative date, once a surgical date has been scheduled."
10784782|NCT03909178|FG001|Participant Flow|Physical Therapy Focused on the Hip and Hemi-pelvis|"Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.~Physical Therapy Focused on the Hip and Hemi-pelvis: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.~Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair or debridement, if repair was not possible, and PT consisted of a uniform, comprehensive PT protocol guided by selected physical therapists.~Those randomized to the physical therapy side will be referred to PT. Those receiving conservative management will be scheduled for physical therapy."
10784783|NCT03909178|OG000|Outcome|SPT Group: Surgery and Physical Therapy|Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
10784784|NCT03909178|OG001|Outcome|PTA Group: Physical Therapy Alone Group|"PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks~1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients."
10801950|NCT02048722|EG000|Reported Event|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO"
10801951|NCT01896102|BG000|Baseline|Lenti-D Drug Product|Participants received a single intravenous (IV) infusion of Lenti-D Drug Product at a dose of greater than or equal to (>=) 5.0 × 10^6 CD34+ cells/kilogram (kg) (autologous CD34+ cell-enriched population that contains cells transduced with lentiviral vector encoding ABCD1 cDNA for human adrenoleukodystrophy protein, suspended in a cryopreservative solution) on Day 0.
10966619|NCT00887822|FG000|Participant Flow|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
11381329|NCT03715829|FG007|Participant Flow|EXT PF-06651600 200 Mg-50 mg QD + nbUVB|Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
11381330|NCT03715829|FG008|Participant Flow|EXT PF-06651600 200 mg - 50 mg QD|Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
11381331|NCT03715829|FG009|Participant Flow|EXT PF-06651600 50 mg QD|Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
11381332|NCT03715829|FG010|Participant Flow|EXT PF-06651600 30 mg QD|Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
11381333|NCT03715829|OG000|Outcome|PF-06651600 200 mg - 50 mg QD|Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381334|NCT03715829|OG001|Outcome|PF-06651600 100 mg - 50 mg QD|Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381335|NCT03715829|OG002|Outcome|PF-06651600 50 mg QD|Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
11381336|NCT03715829|OG003|Outcome|PF-06651600 30 mg QD|Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
11381337|NCT03715829|OG004|Outcome|PF-06651600 10 mg QD|Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
11381338|NCT03715829|OG005|Outcome|Placebo|Participants were randomized to receive placebo for 24 weeks.
11381339|NCT03715829|OG000|Outcome|PF-06651600 200mg - 50mg QD|Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
11381340|NCT03715829|OG000|Outcome|Extension (EXT) PF-06700841 60 mg - 30 mg QD|After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
11381341|NCT03715829|OG001|Outcome|EXT PF-06651600 200 Mg-50 mg QD + nbUVB|Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
11381342|NCT03715829|OG002|Outcome|EXT PF-06651600 200 mg - 50 mg QD|Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
11381343|NCT03715829|OG003|Outcome|EXT PF-06651600 50 mg QD|Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
10801952|NCT01896102|FG000|Participant Flow|Lenti-D Drug Product|Participants received a single intravenous (IV) infusion of Lenti-D Drug Product at a dose of greater than or equal to (>=) 5.0 × 10^6 CD34+ cells/kilogram (kg) (autologous CD34+ cell-enriched population that contains cells transduced with lentiviral vector encoding ABCD1 cDNA for human adrenoleukodystrophy protein, suspended in a cryopreservative solution) on Day 0. Neutrophil Engraftment Population (NEP) is identical to the Transplant Population (TP).
11241007|NCT02483975|BG002|Baseline|Total|Total of all reporting groups
11381344|NCT03715829|OG004|Outcome|EXT PF-06651600 30 mg QD|Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
11381345|NCT03715829|OG003|Outcome|EX PF-06651600 50mg QD|50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.
11381346|NCT03715829|EG000|Reported Event|PF-06651600 200 mg - 50 mg QD|Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381347|NCT03715829|EG001|Reported Event|PF-06651600 100 mg - 50 mg QD|Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
11381348|NCT03715829|EG002|Reported Event|PF-06651600 50 mg QD|Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
11381349|NCT03715829|EG003|Reported Event|PF-06651600 30 mg QD|Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
11381350|NCT03715829|EG004|Reported Event|PF-06651600 10 mg QD|Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
11381351|NCT03715829|EG005|Reported Event|Placebo|Participants were randomized to receive placebo for 24 weeks.
11381352|NCT03715829|EG006|Reported Event|Extension (EXT) PF-06700841 60 mg - 30 mg QD|After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
11381353|NCT03715829|EG007|Reported Event|EX PF-06651600 200 mg - 50 mg QD + nbUVB|Induction dose of PF-06651600 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by maintenance dosing of PF-06651600 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provide nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label.
11381354|NCT03715829|EG008|Reported Event|EX PF-06651600 200mg-50mg QD|Induction dose of 200 mg QD of PF 06651600 for 4 weeks followed by maintenance dosing of 50 mg QD of PF 06651600 for 20 weeks. This arm is double blinded.
11381355|NCT03715829|EG009|Reported Event|EX PF-06651600 50mg QD|50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.
11381356|NCT03715829|EG010|Reported Event|EXT PF-06651600 30 mg QD|Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
11381357|NCT03693430|BG000|Baseline|Semaglutide 2.4 mg|Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
11381358|NCT03693430|BG001|Baseline|Placebo|Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
11381359|NCT03693430|BG002|Baseline|Total|Total of all reporting groups
10784785|NCT03909178|OG000|Outcome|Hip Arthroscopy Surgery With Acetabular Labral Repair|"Hip Arthroscopy Surgery with Acetabular Labral Repair~Hip Arthroscopy Surgery with Acetabular Labral Repair: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.~Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair.~Any subject randomized to surgery will be seen by Dr. Martin to be consented separately for the arthroscopic procedure, which is standard of care. Those receiving surgical management will be scheduled for the post-operative physical therapy protocol within 2 weeks of their operative date, once a surgical date has been scheduled."
10784786|NCT03909178|OG001|Outcome|Physical Therapy Focused on the Hip and Hemi-pelvis|"Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.~Physical Therapy Focused on the Hip and Hemi-pelvis: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.~Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair or debridement, if repair was not possible, and PT consisted of a uniform, comprehensive PT protocol guided by selected physical therapists.~Those randomized to the physical therapy side will be referred to PT. Those receiving conservative management will be scheduled for physical therapy."
10784787|NCT03909178|EG000|Reported Event|SPT Group: Surgery and Physical Therapy|Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement, puncture capsulotomy, autograft capsular augmentation if insufficient or degenerative labral tissue is encountered, intermittent traction, sparing use of electrocautery, and preservation of the chrondrolabral junction. All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months.
10784788|NCT03909178|EG001|Reported Event|PTA Group: Physical Therapy Alone.|PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks 1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
10784789|NCT03662659|BG000|Baseline|BMS986213 + Chemotherapy|BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W
10784790|NCT03662659|BG001|Baseline|Nivolumab + Chemotherapy|Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
10784791|NCT03662659|BG002|Baseline|Total|Total of all reporting groups
10784792|NCT03662659|FG000|Participant Flow|BMS986213 + Chemotherapy|BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W
10784793|NCT03662659|FG001|Participant Flow|Nivolumab + Chemotherapy|Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
10784794|NCT03662659|OG000|Outcome|BMS986213 + Chemotherapy|BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W
11194363|NCT02151994|FG003|Participant Flow|50 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
10784795|NCT03662659|OG001|Outcome|Nivolumab + Chemotherapy|Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
10784796|NCT03662659|EG000|Reported Event|BMS986213 + Chemotherapy|BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W
11194364|NCT02151994|FG004|Participant Flow|100 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
10784797|NCT03662659|EG001|Reported Event|Nivolumab + Chemotherapy|Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
10784798|NCT03631472|BG000|Baseline|RheOx Treatment|"RheOx Treatment (i.e., Bronchial Rheoplasty)~RheOx: RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope."
10784799|NCT03631472|FG000|Participant Flow|RheOx Treatment|"RheOx Treatment (i.e., Bronchial Rheoplasty)~RheOx: RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope."
10784800|NCT03631472|OG000|Outcome|RheOx Treatment|"RheOx Treatment (i.e., Bronchial Rheoplasty)~RheOx: RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope."
10784801|NCT03631472|EG000|Reported Event|RheOx Treatment|"RheOx Treatment (i.e., Bronchial Rheoplasty)~RheOx: RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope."
10784802|NCT03575572|BG000|Baseline|Colchicine|All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.
10784803|NCT03575572|BG001|Baseline|Historical Controls|Historical Controls were post-operative Fontan patients who underwent their operation at the University of Michigan. They were part of a prospective observational study that was published in 2019 which included the chest tube drainage sample collection similar to that done with the Colchicine cohort in this trial.
10784804|NCT03575572|BG002|Baseline|Total|Total of all reporting groups
10784805|NCT03575572|FG000|Participant Flow|Colchicine|All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.
10784806|NCT03575572|OG000|Outcome|Colchicine Per Protocol|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These participants completed the protocol."
10784807|NCT03575572|OG000|Outcome|Colchicine|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These participants completed the protocol."
10784808|NCT03575572|OG001|Outcome|Historical Controls|Historical Controls were post-operative Fontan patients who underwent their operation at the University of Michigan. They were part of a prospective observational study that was published in 2019 which included the chest tube drainage sample collection similar to that done with the Colchicine cohort in this trial.
11241008|NCT02483975|FG000|Participant Flow|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 microgram (mcg) in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10784809|NCT03575572|OG000|Outcome|Colchicine Intention to Treat|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~This group were all of those who began the protocol, whether they completed it or not."
10784810|NCT03575572|OG001|Outcome|Colchicine Per Protocol|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These patients completed the entire protocol."
10784811|NCT03575572|OG001|Outcome|Colchinine Intention to Treat|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These participants were in the trial at least initially, but not all completed the protocol."
10784812|NCT03575572|OG002|Outcome|Historical Controls|Historical Controls were post-operative Fontan patients who underwent their operation at the University of Michigan. They were part of a prospective observational study that was published in 2019 which included the chest tube drainage sample collection similar to that done with the Colchicine cohort in this trial.
10784813|NCT03575572|OG000|Outcome|Colchicine Intention to Treat|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These patients were all those assigned to the protocol whether they completed it or not."
10964640|NCT00878553|OG000|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
10784814|NCT03575572|OG000|Outcome|Colchicine Per Protocol|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~These patients completed the entire protocol."
10784815|NCT03575572|OG001|Outcome|Colchicine Intention to Treat|"All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks.~All of these participants began the protocol, but not all these participants completed the protocol."
10784816|NCT03575572|EG000|Reported Event|Colchicine|"Colchicine will be given at 0.6 mg once daily for the duration of chest tube output plus 24 hours after chest tube removal with a maximum of 4 weeks duration.~Colchicine: Colchicine is an alkaloid approved in 1961 for the use in Familial Mediterranean Fever in adults and children 4 years of age or older. It has been widely used for decades in other indications, such as Gout, recurrent pericarditis, pericardial effusions and other inflammatory diseases. This drug is commercially available and is approved in children 4 years and older."
11194365|NCT02151994|FG005|Participant Flow|200 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
11194366|NCT02151994|FG006|Participant Flow|400 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
11194367|NCT02151994|FG007|Participant Flow|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
11194368|NCT02151994|FG008|Participant Flow|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg.
11194369|NCT02151994|FG009|Participant Flow|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
11194370|NCT02151994|FG010|Participant Flow|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
11194371|NCT02151994|FG011|Participant Flow|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
11194372|NCT02151994|FG012|Participant Flow|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
11194373|NCT02151994|OG000|Outcome|Placebo|Placebo : visually matching active medication
11194374|NCT02151994|OG001|Outcome|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194375|NCT02151994|OG002|Outcome|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194376|NCT02151994|OG003|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194377|NCT02151994|OG004|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194378|NCT02151994|OG005|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194379|NCT02151994|OG006|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194380|NCT02151994|OG007|Outcome|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194381|NCT02151994|OG008|Outcome|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194382|NCT02151994|OG009|Outcome|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194383|NCT02151994|OG001|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11241009|NCT02483975|FG001|Participant Flow|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10784817|NCT03521687|BG000|Baseline|Apremilast|"Patients with CCCA~Apremilast: 30 mg BID"
10784818|NCT03521687|FG000|Participant Flow|Apremilast|"Patients with CCCA~Apremilast: 30 mg BID"
11194384|NCT02151994|OG002|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194385|NCT02151994|OG003|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194386|NCT02151994|OG004|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194387|NCT02151994|OG005|Outcome|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
11194388|NCT02151994|OG000|Outcome|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets
11194389|NCT02151994|OG001|Outcome|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets
11194390|NCT02151994|EG000|Reported Event|Placebo (SAD)|SAD period
11194391|NCT02151994|EG001|Reported Event|5 mg (SAD)|SAD period
11194392|NCT02151994|EG002|Reported Event|25 mg (SAD)|SAD period
11194393|NCT02151994|EG003|Reported Event|50 mg (SAD)|SAD period
11194394|NCT02151994|EG004|Reported Event|100 mg (SAD)|SAD period
11194395|NCT02151994|EG005|Reported Event|200 mg (SAD)|SAD period
11194396|NCT02151994|EG006|Reported Event|400 mg (SAD)|SAD period
11194397|NCT02151994|EG007|Reported Event|800 mg (SAD)|SAD period
11194398|NCT02151994|EG008|Reported Event|1600 mg (SAD)|SAD period
11194399|NCT02151994|EG009|Reported Event|2400 mg (SAD)|SAD period
11194400|NCT02151994|EG010|Reported Event|400 mg Fasted (FE Period)|FE period
11194401|NCT02151994|EG011|Reported Event|400 mg Fed (FE Period)|FE period
11194402|NCT02151994|EG012|Reported Event|Placebo (MAD Period)|MAD period
11194403|NCT02151994|EG013|Reported Event|50 mg (MAD Period)|MAD period
11194404|NCT02151994|EG014|Reported Event|100 mg (MAD Period)|MAD period
11194405|NCT02151994|EG015|Reported Event|200 mg (MAD Period)|MAD period
11194406|NCT02151994|EG016|Reported Event|400 mg (MAD Period)|MAD period
11194407|NCT02151994|EG017|Reported Event|1200 mg (MAD Period)|MAD period
11381360|NCT03693430|FG000|Participant Flow|Semaglutide 2.4 mg|Participants received once-weekly subcutaneous (s.c) injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
11381361|NCT03693430|FG001|Participant Flow|Placebo|Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
11381362|NCT03693430|OG000|Outcome|Semaglutide 2.4 mg|Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
11381363|NCT03693430|OG001|Outcome|Placebo|Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
11381364|NCT03693430|EG000|Reported Event|Semaglutide 2.4 mg|Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
11381365|NCT03693430|EG001|Reported Event|Placebo|Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
11381366|NCT03677934|BG000|Baseline|PDS Implant Arm|Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
11381367|NCT03677934|BG001|Baseline|Intravitreal Arm|Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11381368|NCT03677934|BG002|Baseline|Total|Total of all reporting groups
11381369|NCT03677934|FG000|Participant Flow|PDS Implant Arm|Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
11381370|NCT03677934|FG001|Participant Flow|Intravitreal Arm|Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11381371|NCT03677934|OG000|Outcome|PDS Implant Arm|Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
11381372|NCT03677934|OG001|Outcome|Intravitreal Arm|Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11381373|NCT03677934|EG000|Reported Event|PDS Implant Arm|Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
11381374|NCT03677934|EG001|Reported Event|Intravitreal Arm|Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11381375|NCT03660839|BG000|Baseline|Ferroquine 400 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
11381376|NCT03660839|BG001|Baseline|Ferroquine 400 mg + Artefenomel 300 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
11381377|NCT03660839|BG002|Baseline|Ferroquine 400 mg + Artefenomel 600 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
11381378|NCT03660839|BG003|Baseline|Ferroquine 400 mg + Artefenomel 1000 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
11381379|NCT03660839|BG004|Baseline|Total|Total of all reporting groups
11381380|NCT03660839|FG000|Participant Flow|Ferroquine (FQ) 400 Milligram (mg)|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
11381381|NCT03660839|FG001|Participant Flow|Ferroquine 400 mg + Artefenomel (OZ439) 300 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
11381382|NCT03660839|FG002|Participant Flow|Ferroquine 400 mg + Artefenomel 600 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
11381383|NCT03660839|FG003|Participant Flow|Ferroquine 400 mg + Artefenomel 1000 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
11381384|NCT03660839|OG000|Outcome|Ferroquine 400 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
11381385|NCT03660839|OG001|Outcome|Ferroquine 400 mg + Artefenomel 300 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
11381386|NCT03660839|OG002|Outcome|Ferroquine 400 mg + Artefenomel 600 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
11381387|NCT03660839|OG003|Outcome|Ferroquine 400 mg + Artefenomel 1000 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
11381388|NCT03660839|OG000|Outcome|Ferroquine 400 mg + Artefenomel 300 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
10784819|NCT03521687|OG000|Outcome|Apremilast|"Patients with CCCA~Apremilast: 30 mg BID"
11381389|NCT03660839|OG001|Outcome|Ferroquine 400 mg + Artefenomel 600 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
10784820|NCT03521687|EG000|Reported Event|Apremilast|"Patients with CCCA~Apremilast: 30 mg BID"
11381390|NCT03660839|OG002|Outcome|Ferroquine 400 mg + Artefenomel 1000 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
11381391|NCT03660839|EG000|Reported Event|Ferroquine 400 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
10784821|NCT03511664|BG000|Baseline|177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)|Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
10784822|NCT03511664|BG001|Baseline|Best Supportive/Best Standard of Care (BS/BSOC) Alone|Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
10784823|NCT03511664|BG002|Baseline|Total|Total of all reporting groups
10784824|NCT03511664|FG000|Participant Flow|177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)|Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
10784825|NCT03511664|FG001|Participant Flow|Best Supportive/Best Standard of Care (BS/BSOC) Alone|Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
10784826|NCT03511664|OG000|Outcome|177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)|Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
10784827|NCT03511664|OG001|Outcome|Best Supportive/Best Standard of Care (BS/BSOC) Alone|Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
10784828|NCT03511664|EG000|Reported Event|177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)|Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
10784829|NCT03511664|EG001|Reported Event|Best Supportive/Best Standard of Care (BS/BSOC) Alone|Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
10784830|NCT03461289|BG000|Baseline|Onasemnogene Abeparvovec-xioi|Participants received a single dose of onasemnogene abeparvovec-xioi administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study.
10784831|NCT03461289|FG000|Participant Flow|Onasemnogene Abeparvovec-xioi|Participants received a single dose of onasemnogene abeparvovec-xioi administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study.
10784832|NCT03461289|OG000|Outcome|Onasemnogene Abeparvovec-xioi|Participants received a single dose of onasemnogene abeparvovec-xioi administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study.
10784833|NCT03461289|EG000|Reported Event|Onasemnogene Abeparvovec-xioi|Participants received a single dose of onasemnogene abeparvovec-xioi administered as an intravenous (IV) infusion over 60 minutes at a dose of 1.1 × 10^14 vg/kg (vector genome per kilogram) on Day 1 of the overall study.
10784834|NCT03406507|BG000|Baseline|Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab.
10784835|NCT03406507|BG001|Baseline|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab.
10784836|NCT03406507|BG002|Baseline|Total|Total of all reporting groups
10784837|NCT03406507|FG000|Participant Flow|Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab.
10784838|NCT03406507|FG001|Participant Flow|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab.
10784839|NCT03406507|OG000|Outcome|Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab.
10784840|NCT03406507|OG001|Outcome|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab.
10784841|NCT03406507|EG000|Reported Event|Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab.
10784842|NCT03406507|EG001|Reported Event|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab.
10784843|NCT03256045|BG000|Baseline|Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone|Patients undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay. Regardless of assay results, patients receive panobinostat PO on days 1, 3, 5, 15, 17, and 19, and carfilzomib IV and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
10784844|NCT03256045|FG000|Participant Flow|Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone|Patients undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay. Regardless of assay results, patients receive panobinostat PO on days 1, 3, 5, 15, 17, and 19, and carfilzomib IV and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
10784845|NCT03256045|OG000|Outcome|Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone|Patients undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay. Regardless of assay results, patients receive panobinostat PO on days 1, 3, 5, 15, 17, and 19, and carfilzomib IV and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
10784846|NCT03256045|EG000|Reported Event|Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone|Patients undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay. Regardless of assay results, patients receive panobinostat PO on days 1, 3, 5, 15, 17, and 19, and carfilzomib IV and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
10784847|NCT03216499|BG000|Baseline|Treatment (HIF-2 Alpha Inhibitor PT2385)|"Patients receive HIF-2 alpha inhibitor PT2385 PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study~Laboratory Biomarker Analysis~Pharmacogenomic Study~HIF-2alpha Inhibitor PT2385: Given PO~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies"
10784848|NCT03216499|FG000|Participant Flow|Treatment (HIF-2 Alpha Inhibitor PT2385)|"Patients receive hypoxia inducible factor (HIF)-2 alpha inhibitor PT2385 per os (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study~Laboratory Biomarker Analysis~Pharmacogenomic Study~HIF-2 alpha Inhibitor PT2385: Given PO~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies"
10784849|NCT03216499|OG000|Outcome|Treatment (HIF-2 Alpha Inhibitor PT2385)|"Patients receive HIF-2 alpha inhibitor PT2385 PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study~Laboratory Biomarker Analysis~Pharmacogenomic Study~HIF-2alpha Inhibitor PT2385: Given PO~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies"
10784850|NCT03216499|EG000|Reported Event|Treatment (HIF-2 Alpha Inhibitor PT2385)|"Patients receive HIF-2 alpha inhibitor PT2385 PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study~Laboratory Biomarker Analysis~Pharmacogenomic Study~HIF-2alpha Inhibitor PT2385: Given PO~Pharmacological Study: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacogenomic Study: Correlative studies"
10801953|NCT01896102|OG000|Outcome|Lenti-D Drug Product|Participants received a single intravenous (IV) infusion of Lenti-D Drug Product at a dose of greater than or equal to (>=) 5.0 × 10^6 CD34+ cells/kilogram (kg) (autologous CD34+ cell-enriched population that contains cells transduced with lentiviral vector encoding ABCD1 cDNA for human adrenoleukodystrophy protein, suspended in a cryopreservative solution) on Day 0.
10801954|NCT01896102|OG000|Outcome|Lenti-D Drug Product|Participants received a single intravenous (IV) infusion of Lenti-D Drug Product at a dose of greater than or equal to (>=) 5.0 × 10^6 CD34+ cells/kilogram (kg) (autologous CD34+ cell-enriched population that contained cells transduced with lentiviral vector encoding ABCD1 cDNA for human adrenoleukodystrophy protein, suspended in a cryopreservative solution) on Day 0.
10801955|NCT01896102|EG000|Reported Event|Lenti-D Drug Product|Participants received a single intravenous (IV) infusion of Lenti-D Drug Product at a dose of greater than or equal to (>=) 5.0 × 10^6 CD34+ cells/kilogram (kg) (autologous CD34+ cell-enriched population that contains cells transduced with lentiviral vector encoding ABCD1 cDNA for human adrenoleukodystrophy protein, suspended in a cryopreservative solution) on Day 0.
10801956|NCT01885078|BG000|Baseline|JADZ 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801957|NCT01885078|BG001|Baseline|JADV 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801958|NCT01885078|BG002|Baseline|JADX 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801959|NCT01885078|BG003|Baseline|JADX 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801960|NCT01885078|BG004|Baseline|JADW 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801961|NCT01885078|BG005|Baseline|JADW 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801962|NCT01885078|BG006|Baseline|JAGS 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801963|NCT01885078|BG007|Baseline|JADA 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801964|NCT01885078|BG008|Baseline|Total|Total of all reporting groups
10801965|NCT01885078|FG000|Participant Flow|JADZ 4 Milligram (mg) Baricitinib|4 mg Baricitinib administered orally once daily.
10801966|NCT01885078|FG001|Participant Flow|JADV 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801967|NCT01885078|FG002|Participant Flow|JADX 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801968|NCT01885078|FG003|Participant Flow|JADX 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801969|NCT01885078|FG004|Participant Flow|JADW 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801970|NCT01885078|FG005|Participant Flow|JADW 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801971|NCT01885078|FG006|Participant Flow|JAGS 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801972|NCT01885078|FG007|Participant Flow|JADA 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801973|NCT01885078|FG008|Participant Flow|2 mg Baricitinib Step-down|2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
11381392|NCT03660839|EG001|Reported Event|Ferroquine 400 mg + Artefenomel 300 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
10801974|NCT01885078|FG009|Participant Flow|4 mg Baricitinib Step-down|4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
10801975|NCT01885078|OG000|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801976|NCT01885078|OG001|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801977|NCT01885078|OG002|Outcome|2 mg Baricitinib Step-down|2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
10801978|NCT01885078|OG003|Outcome|4 mg Baricitinib Step-down|4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
10801979|NCT01885078|OG000|Outcome|JADZ 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801980|NCT01885078|OG001|Outcome|JADV 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801981|NCT01885078|OG002|Outcome|JADX 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801982|NCT01885078|OG003|Outcome|JADX 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801983|NCT01885078|OG004|Outcome|JADW 2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
10801984|NCT01885078|OG005|Outcome|JADW 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801985|NCT01885078|OG006|Outcome|JAGS 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801986|NCT01885078|OG007|Outcome|JADA 4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
10801987|NCT01885078|OG000|Outcome|JADZ 4 Milligram (mg) Baricitinib|4 mg Baricitinib administered orally once daily.
10801988|NCT01885078|OG000|Outcome|2 mg Baricitinib Step-down|2 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
10801989|NCT01885078|OG001|Outcome|4 mg Baricitinib Step-down|4 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
11381393|NCT03660839|EG002|Reported Event|Ferroquine 400 mg + Artefenomel 600 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
11381394|NCT03660839|EG003|Reported Event|Ferroquine 400 mg + Artefenomel 1000 mg|On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
11241010|NCT02483975|OG000|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10784851|NCT03046836|BG000|Baseline|Oxytocin|"Each participant will self-administer 40 IU intranasal Oxytocin~Oxytocin: 40 IU oxytocin nasal spray"
11381395|NCT03660241|BG000|Baseline|Normal Renal Function|Participants were selected and categorized into the normal renal function group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=90 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381396|NCT03660241|BG001|Baseline|Moderate Renal Impairment|Participants were selected and categorized into the moderate renal impairment group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=30 and <60 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381397|NCT03660241|BG002|Baseline|Severe Renal Impairment|Participants were selected and categorized into the severe renal impairment group with the estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) formula <30 mL/min on Day -1 and not requiring dialysis. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381398|NCT03660241|BG003|Baseline|Total|Total of all reporting groups
11381399|NCT03660241|FG000|Participant Flow|Normal Renal Function|Participants were selected and categorized into the normal renal function group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=90 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381400|NCT03660241|FG001|Participant Flow|Moderate Renal Impairment|Participants were selected and categorized into the moderate renal impairment group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=30 and <60 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381401|NCT03660241|FG002|Participant Flow|Severe Renal Impairment|Participants were selected and categorized into the severe renal impairment group with the estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) formula <30 mL/min on Day -1 and not requiring dialysis. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381402|NCT03660241|OG000|Outcome|Normal Renal Function|Participants were selected and categorized into the normal renal function group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=90 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381403|NCT03660241|OG001|Outcome|Moderate Renal Impairment|Participants were selected and categorized into the moderate renal impairment group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=30 and <60 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381404|NCT03660241|OG002|Outcome|Severe Renal Impairment|Participants were selected and categorized into the severe renal impairment group with the estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) formula <30 mL/min on Day -1 and not requiring dialysis. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381405|NCT03660241|EG000|Reported Event|Normal Renal Function|Participants were selected and categorized into the normal renal function group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=90 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381406|NCT03660241|EG001|Reported Event|Moderate Renal Impairment|Participants were selected and categorized into the moderate renal impairment group with the estimated glomerular filtration rate (eGRF) based on Modification of Diet in Renal Disease (MDRD) formula >=30 and <60 mL/min on Day -1. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
11381407|NCT03660241|EG002|Reported Event|Severe Renal Impairment|Participants were selected and categorized into the severe renal impairment group with the estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) formula <30 mL/min on Day -1 and not requiring dialysis. Participants received a single 200 mg oral dose of PF-04965842 on Day 1 after a fast of at least 10 hours.
10784852|NCT03046836|BG001|Baseline|Control|"Each participant will self-administer matching saline placebo~Placebo: Saline"
11381408|NCT03575104|BG000|Baseline|Daridorexant 10 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381409|NCT03575104|BG001|Baseline|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381410|NCT03575104|BG002|Baseline|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381411|NCT03575104|BG003|Baseline|Total|Total of all reporting groups
11381412|NCT03575104|FG000|Participant Flow|Daridorexant 10 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381413|NCT03575104|FG001|Participant Flow|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381414|NCT03575104|FG002|Participant Flow|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381415|NCT03575104|OG000|Outcome|Daridorexant 10 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381416|NCT03575104|OG001|Outcome|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381417|NCT03575104|OG002|Outcome|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381418|NCT03575104|EG000|Reported Event|Daridorexant 10 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381419|NCT03575104|EG001|Reported Event|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381420|NCT03575104|EG002|Reported Event|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381421|NCT03569475|BG000|Baseline|Placebo|Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period.
10784853|NCT03046836|BG002|Baseline|Total|Total of all reporting groups
10784854|NCT03046836|FG000|Participant Flow|Oxytocin|"Each participant will self-administer 40 IU intranasal Oxytocin~Oxytocin: 40 IU oxytocin nasal spray"
10784855|NCT03046836|FG001|Participant Flow|Control|"Each participant will self-administer matching saline placebo~Placebo: Saline"
10784856|NCT03046836|OG000|Outcome|Oxytocin|"Each participant will self-administer 40 IU intranasal Oxytocin (OT)~Oxytocin: 40 IU oxytocin nasal spray"
10784857|NCT03046836|OG001|Outcome|Control|"Each participant will self-administer matching saline placebo~Placebo: Saline"
10784858|NCT03046836|OG000|Outcome|Oxytocin|"Each participant will self-administer 40 IU intranasal Oxytocin~Oxytocin: 40 IU oxytocin nasal spray"
10784859|NCT03046836|EG000|Reported Event|Oxytocin|"Each participant will self-administer 40 IU intranasal Oxytocin~Oxytocin: 40 IU oxytocin nasal spray"
10784860|NCT03046836|EG001|Reported Event|Control|"Each participant will self-administer matching saline placebo~Placebo: Saline"
10784861|NCT02966301|BG000|Baseline|Arsenic Trioxide|"Single arm : Arsenic trioxide~Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).~Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8-10 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.~The study duration was 3.5 years (36 months recruitment + 12 months follow-up)."
10784862|NCT02966301|FG000|Participant Flow|Arsenic Trioxide Injectable Solution|"Single arm : Arsenic trioxide Injectable Solution~Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).~Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.~The study duration will be 2 years (12 months recruitment + 12 months follow-up)."
10784863|NCT02966301|OG000|Outcome|Interventional|"Single arm : Arsenic trioxide Injectable Solution~Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).~Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.~The study duration will be 2 years (12 months recruitment + 12 months follow-up)."
10784864|NCT02966301|EG000|Reported Event|Arsenic Trioxide Infusion|Single arm : Arsenic trioxide Injectable Solution
10784865|NCT02941926|BG000|Baseline|Ribociclib + Letrozole + Goserelin/Leuprolide|Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
10784866|NCT02941926|FG000|Participant Flow|Ribociclib + Letrozole + Goserelin/Leuprolide|Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
10784867|NCT02941926|OG000|Outcome|Ribociclib + Letrozole + Goserelin/Leuprolide|Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
10784868|NCT02941926|OG000|Outcome|Primary Resistance Cohort|Participants included in the sub-study treated with ribociclib in combination with letrozole and goserelin or leuprolide (for men and premenopausal women) who did not achieve clinical benefit (tumor progressed within 3 months of treatment)
10784869|NCT02941926|OG001|Outcome|Sensitive Cohort|Participants included in the sub-study treated with ribociclib in combination with letrozole and goserelin or leuprolide (for men and premenopausal women) who were sensitive to treatment (with time to progression of 22 months or more)
10784870|NCT02941926|EG000|Reported Event|Ribociclib + Letrozole + Goserelin/Leuprolide|Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
10784871|NCT02893514|BG000|Baseline|Screening Only (SO)|Screening Only (SO) condition: Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
10784872|NCT02893514|BG001|Baseline|Substance Use Screening and Intervention Tool (SUSIT)|SUSIT Condition: Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
10784873|NCT02893514|BG002|Baseline|Total|Total of all reporting groups
10784874|NCT02893514|FG000|Participant Flow|Screening Only (SO)|Screening Only (SO) condition: Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
10801990|NCT01885078|EG000|Reported Event|2 mg Baricitinib|2 mg Baricitinib administered orally once daily throughout the 84-month treatment period.
11241011|NCT02483975|OG001|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10801991|NCT01885078|EG001|Reported Event|4 mg Baricitinib|4 mg Baricitinib administered orally once daily throughout the 84-month treatment period.
10801992|NCT01885078|EG002|Reported Event|2 mg Baricitinib Step-Down|2 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
11381422|NCT03569475|BG001|Baseline|Levomilnacipran ER 40-80 mg/Day|Levomilnacipran ER capsules, orally, 10 mg/day on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
11381423|NCT03569475|BG002|Baseline|Fluoxetine 20 mg/Day|Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
11381424|NCT03569475|BG003|Baseline|Total|Total of all reporting groups
11381425|NCT03569475|FG000|Participant Flow|Placebo|Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period.
11381426|NCT03569475|FG001|Participant Flow|Levomilnacipran ER 40-80 mg/Day|Levomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
11381427|NCT03569475|FG002|Participant Flow|Fluoxetine 20 mg/Day|Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
11381428|NCT03569475|OG000|Outcome|Placebo|Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period.
11381429|NCT03569475|OG001|Outcome|Levomilnacipran ER 40-80 mg/Day|Levomilnacipran ER capsules, orally, 10 mg/day on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
11381430|NCT03569475|OG002|Outcome|Fluoxetine 20 mg/Day|Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
11381431|NCT03569475|EG000|Reported Event|Placebo (Double-blind Treatment Period)|Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period.
10801993|NCT01885078|EG003|Reported Event|4 mg Baricitinib Step-Down|4 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
10801994|NCT01047683|BG000|Baseline|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
10801995|NCT01047683|BG001|Baseline|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
10801996|NCT01047683|BG002|Baseline|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
10801997|NCT01047683|BG003|Baseline|Total|Total of all reporting groups
10801998|NCT01047683|FG000|Participant Flow|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
10801999|NCT01047683|FG001|Participant Flow|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
10802000|NCT01047683|FG002|Participant Flow|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
10802001|NCT01047683|OG000|Outcome|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
10802002|NCT01047683|OG001|Outcome|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
10802003|NCT01047683|OG002|Outcome|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
10802004|NCT01047683|EG000|Reported Event|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
10802005|NCT01047683|EG001|Reported Event|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
10802006|NCT01047683|EG002|Reported Event|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
10802007|NCT01047501|BG000|Baseline|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks
10802008|NCT01047501|BG001|Baseline|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
10802009|NCT01047501|BG002|Baseline|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
10802010|NCT01047501|BG003|Baseline|Total|Total of all reporting groups
10802011|NCT01047501|FG000|Participant Flow|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks
10802012|NCT01047501|FG001|Participant Flow|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
10802013|NCT01047501|FG002|Participant Flow|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
10802014|NCT01047501|OG000|Outcome|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
10802015|NCT01047501|OG001|Outcome|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
10802016|NCT01047501|OG002|Outcome|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks
10964641|NCT00878553|OG000|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
10964642|NCT00878553|OG001|Outcome|10 mg SKP=1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
11194408|NCT02152007|BG000|Baseline|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
11381432|NCT03569475|EG001|Reported Event|Levomilnacipran ER 40-80 mg/Day (Double-blind Treatment Period)|Levomilnacipran ER capsules, orally, 10 mg/day on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
10802017|NCT01047501|EG000|Reported Event|Placebo|Placebo: Placebo 4 capsules/day for 12 weeks
10802018|NCT01047501|EG001|Reported Event|AMR101 (Ethyl Icosapentate) - 2 g/Day|AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
10802019|NCT01047501|EG002|Reported Event|AMR101 (Ethyl Icosapentate) - 4 g/Day|AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
10802020|NCT00981656|BG000|Baseline|3DCRT + CT|Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
11194409|NCT02152007|FG000|Participant Flow|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
11194410|NCT02152007|OG000|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
11194411|NCT02152007|OG001|Outcome|Placebo Cream (Vehicle Control)|Placebo Cream (Vehicle Control)
11194412|NCT02152007|EG000|Reported Event|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
11194413|NCT02152085|BG000|Baseline|Narrow Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.~Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses."
11194414|NCT02152085|BG001|Baseline|Wide Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.~Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses."
10802021|NCT00981656|FG000|Participant Flow|3DCRT + CT|Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
10802022|NCT00981656|OG000|Outcome|3DCRT + CT|Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
10802023|NCT00981656|EG000|Reported Event|3DCRT + CT|Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
11194415|NCT02152085|BG002|Baseline|Total|Total of all reporting groups
11194416|NCT02152085|FG000|Participant Flow|Narrow Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.~Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses."
11381433|NCT03569475|EG002|Reported Event|Fluoxetine 20 mg/Day (Double-blind Treatment Period)|Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period.
11381434|NCT03569475|EG003|Reported Event|Placebo (Down-taper Period)|Matching placebo capsules once daily on Days 1 through 7 in the Down-taper Period.
11381435|NCT03569475|EG004|Reported Event|Levomilnacipran ER 40-80 mg/Day (Down-taper Period)|Levomilnacipran ER capsules, orally, 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
11381436|NCT03569475|EG005|Reported Event|Fluoxetine 20 mg/Day (Down-taper Period)|Fluoxetine capsule, orally, 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
11381437|NCT03554798|BG000|Baseline|Stage I - Group A2H2|50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
11381438|NCT03554798|BG001|Baseline|Stage II - A1H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
11381439|NCT03554798|BG002|Baseline|Stage II - A2H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
11381440|NCT03554798|BG003|Baseline|Stage I -- Group B2L1+L2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
11381441|NCT03554798|BG004|Baseline|Stage I - B2H1+H2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
11381442|NCT03554798|BG005|Baseline|Stage II - Group B1L1+L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
11381443|NCT03554798|BG006|Baseline|Stage II - Group B1H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
11381444|NCT03554798|BG007|Baseline|Stage II - Group B2L1 +L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
11381445|NCT03554798|BG008|Baseline|Stage II - Group B2H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
10802024|NCT00838526|BG000|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802025|NCT00838526|BG001|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802026|NCT00838526|BG002|Baseline|Total|Total of all reporting groups
10802027|NCT00838526|FG000|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802028|NCT00838526|FG001|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802029|NCT00838526|OG000|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802030|NCT00838526|OG001|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802031|NCT00838526|EG000|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802032|NCT00838526|EG001|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
10802033|NCT00126672|BG000|Baseline|Ramaycin|"After the screening procedures confirm that you are eligible to participate in the research study~Rapamycin: oral, 3-9 ng/ml daily for 4 months, then increase dose to 9-15 ng/ml for 20 months.~MRI/CT scan at 16 week, 32 weeks, 52 weeks during treatments."
11381446|NCT03554798|BG009|Baseline|Total|Total of all reporting groups
11381447|NCT03554798|FG000|Participant Flow|Stage I - Group A2H2|50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
11381448|NCT03554798|FG001|Participant Flow|Stage II - A1H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
11381449|NCT03554798|FG002|Participant Flow|Stage II - A2H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
11381450|NCT03554798|FG003|Participant Flow|Stage I -- Group B2L1+L2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
11381451|NCT03554798|FG004|Participant Flow|Stage I - B2H1+H2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
11381452|NCT03554798|FG005|Participant Flow|Stage II - Group B1L1+L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
11381453|NCT03554798|FG006|Participant Flow|Stage II - Group B1H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
11381454|NCT03554798|FG007|Participant Flow|Stage II - Group B2L1+L2 [2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
11381455|NCT03554798|FG008|Participant Flow|Stage II - Group B2H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
11381456|NCT03554798|OG000|Outcome|Stage I - Group A2H2|50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
11381457|NCT03554798|OG001|Outcome|Stage II - A1H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
11381458|NCT03554798|OG002|Outcome|Stage II - A2H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
11381459|NCT03554798|OG003|Outcome|Stage I -- Group B2L1+L2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
11381460|NCT03554798|OG004|Outcome|Stage I - B2H1+H2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
11381461|NCT03554798|OG005|Outcome|Stage II - Group B1L1+L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
11381462|NCT03554798|OG006|Outcome|Stage II - Group B1H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
11381463|NCT03554798|OG007|Outcome|Stage II - Group B2L1 +L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
11381464|NCT03554798|OG008|Outcome|Stage II - Group B2H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
11381465|NCT03554798|OG003|Outcome|Stage I -- Group B2L1+L2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
10802034|NCT00126672|FG000|Participant Flow|Rapamycin|"After the screening procedures confirm that you are eligible to participate in the research study~Rapamycin: oral, 3-9 ng/ml daily for 4 months, then increase dose to 9-15 ng/ml for 20 months.~MRI/CT scan at 16 week, 32 weeks, 52 weeks during treatments."
11381466|NCT03554798|OG005|Outcome|Stage II - Group B1L1+L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
11381467|NCT03554798|OG007|Outcome|Stage II - Group B2L1+L2 [2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
11381468|NCT03554798|EG000|Reported Event|Stage I - Group A2H2|50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]).
11381469|NCT03554798|EG001|Reported Event|Stage II - A1H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
11381470|NCT03554798|EG002|Reported Event|Stage II - A2H2 [2018]|50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
10802035|NCT00126672|OG000|Outcome|Ramaycin|"After the screening procedures confirm that you are eligible to participate in the research study~Rapamycin: oral, 3-9 ng/ml daily for 4 months, then increase dose to 9-15 ng/ml for 20 months.~MRI/CT scan at 16 week, 32 weeks, 52 weeks during treatments."
11381471|NCT03554798|EG003|Reported Event|Stage I -- Group B2L1+L2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
11381472|NCT03554798|EG004|Reported Event|Stage I - B2H1+H2[2016]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
11381473|NCT03554798|EG005|Reported Event|Stage II - Group B1L1+L2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
11381474|NCT03554798|EG006|Reported Event|Stage II - Group B1H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
11381475|NCT03554798|EG007|Reported Event|Stage II - Group B2L1+L2 [2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later.
11381476|NCT03554798|EG008|Reported Event|Stage II - Group B2H1+H2[2018]|162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later.
11381477|NCT03545191|BG000|Baseline|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381478|NCT03545191|BG001|Baseline|Daridorexant 50 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381479|NCT03545191|BG002|Baseline|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381480|NCT03545191|BG003|Baseline|Total|Total of all reporting groups
11381481|NCT03545191|FG000|Participant Flow|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381482|NCT03545191|FG001|Participant Flow|Daridorexant 50 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381483|NCT03545191|FG002|Participant Flow|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381484|NCT03545191|OG000|Outcome|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381485|NCT03545191|OG001|Outcome|Daridorexant 50 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381486|NCT03545191|OG002|Outcome|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381487|NCT03545191|EG000|Reported Event|Daridorexant 25 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381488|NCT03545191|EG001|Reported Event|Daridorexant 50 mg|Daridorexant was administered as tablets, orally, once daily in the evening.
11381489|NCT03545191|EG002|Reported Event|Placebo|Matching placebo was administered as tablets, orally, once daily in the evening.
11381490|NCT03500549|BG000|Baseline|Pegcetacoplan to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381491|NCT03500549|BG001|Baseline|Eculizumab to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks up to the end of the RCP (Week 16). Subjects then entered the open-label run-in period where they received pegcetacoplan 1080 mg twice-weekly in addition to eculizumab for 4 weeks (Week 17 to Week 20) before crossing over to monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381492|NCT03500549|BG002|Baseline|Total|Total of all reporting groups
11381493|NCT03500549|FG000|Participant Flow|Pegcetacoplan to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly subcutaneous (SC) doses of pegcetacoplan 1080 milligrams (mg) in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381494|NCT03500549|FG001|Participant Flow|Eculizumab to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks up to the end of the RCP (Week 16). Subjects then entered the open-label run-in period where they received pegcetacoplan 1080 mg twice-weekly in addition to eculizumab for 4 weeks (Week 17 to Week 20) before crossing over to monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381495|NCT03500549|OG000|Outcome|Pegcetacoplan to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381496|NCT03500549|OG001|Outcome|Eculizumab to Pegcetacoplan|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. On Day 1, the subjects were randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks up to the end of the RCP (Week 16). Subjects then entered the open-label run-in period where they received pegcetacoplan 1080 mg twice-weekly in addition to eculizumab for 4 weeks (Week 17 to Week 20) before crossing over to monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381497|NCT03500549|OG000|Outcome|Open-label Period: Continue Pegcetacoplan|On Day 1 of the RCP, the subjects were randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381498|NCT03500549|OG001|Outcome|Open-label Period: Crossover to Pegcetacoplan|Subjects entered the open-label run-in period where they received pegcetacoplan 1080 mg twice-weekly in addition to eculizumab for 4 weeks (Week 17 to Week 20) before receiving monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days up to the end of the open-label period (Week 48).
11381499|NCT03500549|OG002|Outcome|Open-label Run-in Period: Crossover to Pegcetacoplan|Subjects in the open-label run-in period received pegcetacoplan 1080 mg twice-weekly in addition to eculizumab for 4 weeks (Week 17 to Week 20).
11381500|NCT03500549|EG000|Reported Event|Run-in Period: Pegcetacoplan + Eculizumab|During the 4-week run-in period (Day -28 to ≤Day 1) all subjects received twice-weekly SC doses of pegcetacoplan 1080 mg in addition to their current dosage of eculizumab treatment. During the 4-week open-label run-in period (Week 17 to Week 20) subjects randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks during the RCP also received twice-weekly SC doses of pegcetacoplan 1080 mg.
11381501|NCT03500549|EG001|Reported Event|Open-label Period: Pegcetacoplan|The subjects who were randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days during the RCP continued to receive monotherapy with pegcetacoplan until the end of the open-label period (Week 17 to Week 48). Subjects randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks during the RCP received monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days after the open-label run-in period, up to the end of the open-label period (Week 20 to Week 48).
11381502|NCT03500549|EG002|Reported Event|RCP: Eculizumab|Subjects randomized to receive monotherapy with their pre-screening stable dose of eculizumab via intravenous infusion every 2 weeks during the RCP.
11381503|NCT03500549|EG003|Reported Event|RCP: Pegcetacoplan|Subjects randomized to receive monotherapy with SC infusions of pegcetacoplan 1080 mg twice-weekly or every 3 days during the RCP.
11381504|NCT03456700|BG000|Baseline|Treatment (Auranofin, Sirolimus)|Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
11381505|NCT03456700|FG000|Participant Flow|Treatment (Auranofin, Sirolimus)|Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
11381506|NCT03456700|OG000|Outcome|Treatment (Auranofin, Sirolimus)|Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
11381507|NCT03456700|EG000|Reported Event|Treatment (Auranofin, Sirolimus)|Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
10802036|NCT00126672|EG000|Reported Event|Ramaycin|"After the screening procedures confirm that you are eligible to participate in the research study~Rapamycin: oral, 3-9 ng/ml daily for 4 months, then increase dose to 9-15 ng/ml for 20 months.~MRI/CT scan at 16 week, 32 weeks, 52 weeks during treatments."
11241012|NCT02483975|OG001|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10802037|NCT03172780|BG000|Baseline|Diclofenac Sodium Gel|"Diclofenac Sodium Gel, 1%~Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10802038|NCT03172780|BG001|Baseline|Voltaren® Gel|"Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%~Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10802039|NCT03172780|BG002|Baseline|Placebo Gel|"Placebo gel~Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks"
10802040|NCT03172780|BG003|Baseline|Total|Total of all reporting groups
11194417|NCT02152085|FG001|Participant Flow|Wide Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.~Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses."
11194418|NCT02152085|OG000|Outcome|Narrow Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.~Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses."
11381508|NCT03435185|BG000|Baseline|Blockade Group|"Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine~Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients."
11381509|NCT03435185|BG001|Baseline|Placebo Group|"Grater occipital nerve and supraorbital nerve injections with saline~Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve"
11381510|NCT03435185|BG002|Baseline|Total|Total of all reporting groups
11381511|NCT03435185|FG000|Participant Flow|Blockade Group|"Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine~Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients."
11381512|NCT03435185|FG001|Participant Flow|Placebo Group|"Grater occipital nerve and supraorbital nerve injections with saline~Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve"
11381513|NCT03435185|OG000|Outcome|Blockade Group|"Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine~Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients."
11381514|NCT03435185|OG001|Outcome|Placebo Group|"Grater occipital nerve and supraorbital nerve injections with saline~Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve"
11381515|NCT03435185|EG000|Reported Event|Blockade Group|"Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine~Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients."
11381516|NCT03435185|EG001|Reported Event|Placebo Group|"Grater occipital nerve and supraorbital nerve injections with saline~Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve"
11381517|NCT03427411|BG000|Baseline|Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381518|NCT03427411|BG001|Baseline|Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381519|NCT03427411|BG002|Baseline|Total|Total of all reporting groups
11381520|NCT03427411|FG000|Participant Flow|Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381521|NCT03427411|FG001|Participant Flow|Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381522|NCT03427411|OG000|Outcome|Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381523|NCT03427411|OG001|Outcome|Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381524|NCT03427411|EG000|Reported Event|Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11194419|NCT02152085|OG001|Outcome|Wide Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.~Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses."
10784875|NCT02893514|FG001|Participant Flow|Substance Use Screening and Intervention Tool (SUSIT)|SUSIT Condition: Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
10784876|NCT02893514|OG000|Outcome|Screening Only (SO)|Screening Only (SO) condition: Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
10784877|NCT02893514|OG001|Outcome|Substance Use Screening and Intervention Tool (SUSIT)|SUSIT Condition: Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
10784878|NCT02893514|EG000|Reported Event|Screening Only (SO)|Screening Only (SO) condition: Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
11194420|NCT02152085|EG000|Reported Event|Narrow Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.~Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses."
11194421|NCT02152085|EG001|Reported Event|Wide Pulse|"Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.~Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses."
11194422|NCT02152137|BG000|Baseline|Efatutazone Dihydrochloride, Paclitaxel|Patients receive 175 mg/m^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10784879|NCT02893514|EG001|Reported Event|Substance Use Screening and Intervention Tool (SUSIT)|SUSIT Condition: Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
10784880|NCT02832167|BG000|Baseline|Advanced Malignancies Cohort|Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
10784881|NCT02832167|FG000|Participant Flow|Advanced Malignancies Cohort|Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
10784882|NCT02832167|OG000|Outcome|Advanced Malignancies Cohort|Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
10784883|NCT02832167|EG000|Reported Event|Advanced Malignancies Cohort|Treatment period 1: Nivolumab 240 mg Q2W for 8 doses. Treatment period 2: Nivolumab 480 mg Q4W
10784884|NCT02699554|BG000|Baseline|Orthopaedic Surgery|Single-event multilevel surgery
10784885|NCT02699554|FG000|Participant Flow|Orthopaedic Surgery|Single-event multilevel surgery
10784886|NCT02699554|OG000|Outcome|Orthopaedic Surgery|Single-event multilevel surgery
10784887|NCT02699554|EG000|Reported Event|Orthopaedic Surgery|Single-event multilevel surgery
10784888|NCT02659020|BG000|Baseline|Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784889|NCT02659020|BG001|Baseline|Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10802041|NCT03172780|FG000|Participant Flow|Diclofenac Sodium Gel|"Diclofenac Sodium Gel, 1%~Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10966620|NCT00887822|FG001|Participant Flow|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
11194423|NCT02152137|FG000|Participant Flow|Efatutazone Dihydrochloride, Paclitaxel|Patients receive 175 mg/m^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10784890|NCT02659020|BG002|Baseline|Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784891|NCT02659020|BG003|Baseline|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784892|NCT02659020|BG004|Baseline|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784893|NCT02659020|BG005|Baseline|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784894|NCT02659020|BG006|Baseline|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784895|NCT02659020|BG007|Baseline|Total|Total of all reporting groups
10784896|NCT02659020|FG000|Participant Flow|Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784897|NCT02659020|FG001|Participant Flow|Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784898|NCT02659020|FG002|Participant Flow|Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784899|NCT02659020|FG003|Participant Flow|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784900|NCT02659020|FG004|Participant Flow|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784901|NCT02659020|FG005|Participant Flow|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784902|NCT02659020|FG006|Participant Flow|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10802042|NCT03172780|FG001|Participant Flow|Voltaren® Gel|"Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%~Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10802043|NCT03172780|FG002|Participant Flow|Placebo Gel|"Placebo gel~Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks"
11194424|NCT02152137|OG000|Outcome|Efatutazone Dihydrochloride, Paclitaxel|Patients receive 175 mg/m^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11194425|NCT02152137|EG000|Reported Event|Efatutazone Dihydrochloride, Paclitaxel|Patients receive 175 mg/m^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11194426|NCT02152163|BG000|Baseline|IV Ibuprofen 800 mg|"IV Ibuprofen 800 mg~IV Ibuprofen"
11194427|NCT02152163|BG001|Baseline|IV Saline|"IV Saline~placebo"
10784903|NCT02659020|OG000|Outcome|Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784904|NCT02659020|OG001|Outcome|Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784905|NCT02659020|OG002|Outcome|Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784906|NCT02659020|OG000|Outcome|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784907|NCT02659020|OG001|Outcome|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784908|NCT02659020|OG001|Outcome|Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
10784909|NCT02659020|OG002|Outcome|Phase 2: Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
10784910|NCT02659020|OG003|Outcome|Phase 2: Placebo + Gemcitabine + Docetaxel|Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
10784911|NCT02659020|OG000|Outcome|Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab on days 1, 8 (phase 1: 15 or 20 mg/kg; phase 2: 20 mg/kg only in cycle 1 and 15 mg/kg in subsequent cycles) plus gemcitabine 900 mg/m^2 on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784912|NCT02659020|OG000|Outcome|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784913|NCT02659020|OG001|Outcome|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784914|NCT02659020|OG002|Outcome|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784915|NCT02659020|OG003|Outcome|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10802044|NCT03172780|OG000|Outcome|Diclofenac Sodium Gel|"Diclofenac Sodium Gel, 1%~Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
11194428|NCT02152163|BG002|Baseline|Total|Total of all reporting groups
11194429|NCT02152163|FG000|Participant Flow|IV Ibuprofen 800 mg|"IV Ibuprofen 800 mg~IV Ibuprofen"
11194430|NCT02152163|FG001|Participant Flow|IV Saline|"IV Saline~placebo"
11194431|NCT02152163|OG000|Outcome|IV Ibuprofen 800 mg|"IV Ibuprofen 800 mg~IV Ibuprofen"
11194432|NCT02152163|OG001|Outcome|IV Saline|"IV Saline~placebo"
10784916|NCT02659020|OG001|Outcome|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784917|NCT02659020|EG000|Reported Event|Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784918|NCT02659020|EG001|Reported Event|Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784919|NCT02659020|EG002|Reported Event|Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel|Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784920|NCT02659020|EG003|Reported Event|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784921|NCT02659020|EG004|Reported Event|Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784922|NCT02659020|EG005|Reported Event|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)|This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
10784923|NCT02659020|EG006|Reported Event|Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)|This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
11194433|NCT02152163|EG000|Reported Event|IV Ibuprofen 800 mg|"IV Ibuprofen 800 mg~IV Ibuprofen"
10784924|NCT02626949|BG000|Baseline|MBSR Course|Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
10784925|NCT02626949|BG001|Baseline|HAEP Course|Health & Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
10784926|NCT02626949|BG002|Baseline|Total|Total of all reporting groups
10784927|NCT02626949|FG000|Participant Flow|MBSR Course|Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
11194434|NCT02152163|EG001|Reported Event|IV Saline|"IV Saline~placebo"
11194435|NCT02152345|BG000|Baseline|Belatacept Immunosuppression|"Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84.~Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.~Standard of Care:~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered Day 0-3."
10784928|NCT02626949|FG001|Participant Flow|HAEP Course|Health & Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
10784929|NCT02626949|OG000|Outcome|MBSR Course|Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
10784930|NCT02626949|OG001|Outcome|HAEP Course|Health & Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
10784931|NCT02626949|EG000|Reported Event|MBSR Course|Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
10784932|NCT02626949|EG001|Reported Event|HAEP Course|Health & Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
10802045|NCT03172780|OG001|Outcome|Voltaren® Gel|"Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%~Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10802046|NCT03172780|OG002|Outcome|Placebo Gel|"Placebo gel~Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks"
11381525|NCT03427411|EG001|Reported Event|Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks|Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
11381526|NCT03387150|BG000|Baseline|Group 1: Vaccine|VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
11381527|NCT03387150|BG001|Baseline|Group 2: Vaccine|VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
11381528|NCT03387150|BG002|Baseline|Group 3: Vaccine|VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
11381529|NCT03387150|BG003|Baseline|Group 4: Vaccine|VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
11381530|NCT03387150|BG004|Baseline|Group 5: Vaccine|VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
11381531|NCT03387150|BG005|Baseline|Group 6: Vaccine|VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
11381532|NCT03387150|BG006|Baseline|Group 7: Placebo|IM-0.9% Sodium Chloride wks(0,16,32,48,64)
11381533|NCT03387150|BG007|Baseline|Total|Total of all reporting groups
11381534|NCT03387150|FG000|Participant Flow|Group 1: Vaccine|VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
11381535|NCT03387150|FG001|Participant Flow|Group 2: Vaccine|VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
11381536|NCT03387150|FG002|Participant Flow|Group 3: Vaccine|VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
11381537|NCT03387150|FG003|Participant Flow|Group 4: Vaccine|VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
11381538|NCT03387150|FG004|Participant Flow|Group 5: Vaccine|VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
11381539|NCT03387150|FG005|Participant Flow|Group 6: Vaccine|VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
11381540|NCT03387150|FG006|Participant Flow|Group 7: Placebo|IM-0.9% Sodium Chloride wks(0,16,32,48,64)
11381541|NCT03387150|OG000|Outcome|Group 1: Vaccine|VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
11381542|NCT03387150|OG001|Outcome|Group 2: Vaccine|VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
11381543|NCT03387150|OG002|Outcome|Group 3: Vaccine|VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
11381544|NCT03387150|OG003|Outcome|Group 4: Vaccine|VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
11381545|NCT03387150|OG004|Outcome|Group 5: Vaccine|VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
11381546|NCT03387150|OG005|Outcome|Group 6: Vaccine|VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
11381547|NCT03387150|OG006|Outcome|Group 7: Placebo|IM-0.9% Sodium Chloride wks(0,16,32,48,64)
11381548|NCT03387150|EG000|Reported Event|Group 1: Vaccine|VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
11381549|NCT03387150|EG001|Reported Event|Group 2: Vaccine|VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
11381550|NCT03387150|EG002|Reported Event|Group 3: Vaccine|VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
11381551|NCT03387150|EG003|Reported Event|Group 4: Vaccine|VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
11381552|NCT03387150|EG004|Reported Event|Group 5: Vaccine|VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
11381553|NCT03387150|EG005|Reported Event|Group 6: Vaccine|VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
11381554|NCT03387150|EG006|Reported Event|Group 7: Placebo|IM-0.9% Sodium Chloride wks(0,16,32,48,64)
11381555|NCT03370133|BG000|Baseline|Placebo|Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
11381556|NCT03370133|BG001|Baseline|Bimekizumab (BKZ) 320 Milligrams (mg) Q4W|Participants received bimekizumab 320 mg Q4W for 52 weeks.
11381557|NCT03370133|BG002|Baseline|Ustekinumab (Uste)|Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
11381558|NCT03370133|BG003|Baseline|Total Title|
11381559|NCT03370133|FG000|Participant Flow|Placebo|Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
11381560|NCT03370133|FG001|Participant Flow|Bimekizumab (BKZ) 320 Milligrams (mg) Q4W|Participants received bimekizumab 320 mg Q4W for 52 weeks.
11381561|NCT03370133|FG002|Participant Flow|Ustekinumab (Uste)|Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
11381562|NCT03370133|FG003|Participant Flow|Placebo/Bimekizumab 320 mg Q4W|After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period).
11381563|NCT03370133|FG004|Participant Flow|Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W|After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period.
11381564|NCT03370133|FG005|Participant Flow|Ustekinumab/Ustekinumab|After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period.
11381565|NCT03370133|OG000|Outcome|Placebo (RS)|Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).
11381566|NCT03370133|OG001|Outcome|Bimekizumab 320 mg Q4W (RS)|Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
11381567|NCT03370133|OG002|Outcome|Ustekinumab (RS)|Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
11381568|NCT03370133|OG000|Outcome|Bimekizumab 320 mg Q4W (RS)|Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.
11381569|NCT03370133|OG001|Outcome|Ustekinumab (RS)|Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
11381570|NCT03370133|OG000|Outcome|Placebo (SS)|Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
11381571|NCT03370133|OG001|Outcome|Bimekizumab 320 mg Q4W (SS)|Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.
11381572|NCT03370133|OG002|Outcome|Ustekinumab (SS)|Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
11381573|NCT03370133|OG000|Outcome|Placebo/Bimekizumab 320 mg Q4W (MS)|After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).
11381574|NCT03370133|OG001|Outcome|Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)|After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
11381575|NCT03370133|OG002|Outcome|Ustekinumab/Ustekinumab (MS)|After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.
11381576|NCT03370133|EG000|Reported Event|Placebo Initial Period (SS)|During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).
11381577|NCT03370133|EG001|Reported Event|Bimekizumab 320 mg Q4W Initial Period (SS)|During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS.
11381578|NCT03370133|EG002|Reported Event|Ustekinumab Initial Period (SS)|During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS.
11381579|NCT03370133|EG003|Reported Event|Any Bimekizumab 320 mg Q4W (AMS)|This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS.
11381580|NCT03370133|EG004|Reported Event|Any Ustekinumab (AMS)|This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS.
11381581|NCT03366792|BG000|Baseline|MRI Targeted Biopsy|Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
11381582|NCT03366792|FG000|Participant Flow|MRI Targeted Biopsy|Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
11381583|NCT03366792|OG000|Outcome|MRI Targeted Biopsy|Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
11381584|NCT03366792|EG000|Reported Event|MRI Targeted Biopsy|Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
11381585|NCT03366337|BG000|Baseline|Bardoxolone Methyl - ADPKD|"Participants with autosomal polycystic kidney disease (ADPKD) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381586|NCT03366337|BG001|Baseline|Bardoxolone Methyl - IgAN|"Participants with IgA nephropathy (IgAN) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381587|NCT03366337|BG002|Baseline|Bardoxolone Methyl - T1D|"Participants with Type 1 diabetes (T1D) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381588|NCT03366337|BG003|Baseline|Bardoxolone Methyl - FSGS|"Participants with focal segmental glomerulosclerosis (FSGS) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381589|NCT03366337|BG004|Baseline|Total|Total of all reporting groups
11381590|NCT03366337|FG000|Participant Flow|Bardoxolone Methyl - ADPKD|"Participants with autosomal polycystic kidney disease (ADPKD) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381591|NCT03366337|FG001|Participant Flow|Bardoxolone Methyl - IgAN|"Participants with IgA nephropathy (IgAN) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381592|NCT03366337|FG002|Participant Flow|Bardoxolone Methyl - T1D|"Participants with Type 1 diabetes (T1D) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381593|NCT03366337|FG003|Participant Flow|Bardoxolone Methyl - FSGS|"Participants with focal segmental glomerulosclerosis (FSGS) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381594|NCT03366337|OG000|Outcome|Bardoxolone Methyl - ADPKD|"Participants with autosomal polycystic kidney disease (ADPKD) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
10784933|NCT02625766|BG000|Baseline|Operative|"Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.~LC fracture surgical fixation"
10784934|NCT02625766|BG001|Baseline|Non-operative|"Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.~LC fracture non-operative management"
10784935|NCT02625766|BG002|Baseline|Total|Total of all reporting groups
10784936|NCT02625766|FG000|Participant Flow|Operative|"Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.~LC fracture surgical fixation"
10784937|NCT02625766|FG001|Participant Flow|Non-operative|"Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.~LC fracture non-operative management"
10784938|NCT02625766|OG000|Outcome|Operative|"Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.~LC fracture surgical fixation"
10784939|NCT02625766|OG001|Outcome|Non-operative|"Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.~LC fracture non-operative management"
10784940|NCT02625766|EG000|Reported Event|Operative|"Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.~LC fracture surgical fixation"
10784941|NCT02625766|EG001|Reported Event|Non-operative|"Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.~LC fracture non-operative management"
10784942|NCT02565914|BG000|Baseline|Part A: TEZ/IVA|All participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 103, 106, 107,108, 109 and 111 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784943|NCT02565914|FG000|Participant Flow|Part A: TEZ/IVA|All participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 103, 106, 107,108, 109 and 111 were to be administered TEZ 100 milligram (mg)/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784944|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 103, 106, 107,108, 109 and 111 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784945|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo or TEZ/IVA in parent study 106 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784946|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo or IVA monotherapy or TEZ/IVA in parent study 108 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784947|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received TEZ/IVA in parent study 103 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784948|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo and TEZ/IVA in parent study 111 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784949|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo or TEZ/IVA in parent study 106 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in part A of this study.
10784950|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo or TEZ/IVA in parent study 106 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784951|NCT02565914|OG000|Outcome|Part A: TEZ/IVA|All participants who received Placebo or IVA monotherapy or TEZ/IVA in parent study 108 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
10784952|NCT02565914|OG000|Outcome|Part A: All Participants|All participants who received TEZ/IVA or IVA monotherapy or Placebo in parent studies (103, 106, 107,108, 109 and 111) were to be administered TEZ 100 micrograms (mg)/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg in the evening for 96 weeks in Part A of this study.
10784953|NCT02565914|EG000|Reported Event|Part A: TEZ/IVA|All participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 103, 106, 107,108, 109 and 111 were to be administered TEZ 100 mg/IVA 150 mg fixed-dose combination tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks in Part A of this study.
11381595|NCT03366337|OG001|Outcome|Bardoxolone Methyl - IgAN|"Participants with IgA nephropathy (IgAN) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381596|NCT03366337|OG002|Outcome|Bardoxolone Methyl - T1D|"Participants with Type 1 diabetes (T1D) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381597|NCT03366337|OG003|Outcome|Bardoxolone Methyl - FSGS|"Participants with focal segmental glomerulosclerosis (FSGS) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381598|NCT03366337|EG000|Reported Event|Bardoxolone Methyl - ADPKD|"Participants with autosomal polycystic kidney disease (ADPKD) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381599|NCT03366337|EG001|Reported Event|Bardoxolone Methyl - IgAN|"Participants with IgA nephropathy (IgAN) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381600|NCT03366337|EG002|Reported Event|Bardoxolone Methyl - T1D|"Participants with Type 1 diabetes (T1D) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381601|NCT03366337|EG003|Reported Event|Bardoxolone Methyl - FSGS|"Participants with focal segmental glomerulosclerosis (FSGS) who received bardoxolone methyl capsules at a starting dose of 5 mg and titrate up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily.~Bardoxolone methyl capsules: Bardoxolone 5 mg capsules"
11381602|NCT03342053|BG000|Baseline|RO7234292 Monthly|RO7234292 was administered intrathecally every 28 days for 14 months.
11381603|NCT03342053|BG001|Baseline|RO7234292 Bimonthly|RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose.
11381604|NCT03342053|BG002|Baseline|Total|Total of all reporting groups
10802047|NCT03172780|EG000|Reported Event|Diclofenac Sodium Gel|"Diclofenac Sodium Gel, 1%~Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
11381605|NCT03342053|FG000|Participant Flow|RO7234292 Monthly|RO7234292 was administered intrathecally every 28 days for 14 months.
11381606|NCT03342053|FG001|Participant Flow|RO7234292 Bimonthly|RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose.
11381607|NCT03342053|OG000|Outcome|RO7234292 Monthly|RO7234292 was administered intrathecally every 28 days for 14 months.
11381608|NCT03342053|OG001|Outcome|RO7234292 Bimonthly|RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose.
11381609|NCT03342053|EG000|Reported Event|RO7234292 Monthly|RO7234292 was administered intrathecally every 28 days for 14 months.
11381610|NCT03342053|EG001|Reported Event|RO7234292 Bimonthly|RO7234292 was administered intrathecally every 56 days for 14 months following 2 monthly doses to serve as a loading dose.
11381611|NCT03330847|BG000|Baseline|Olaparib Monotherapy|Randomized patients received olaparib monotherapy 300 mg twice daily (BD) [28-day cycle], until objective radiological disease progression as per Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1) as assessed by the Investigator or until any other discontinuation criteria were met.
11381612|NCT03330847|BG001|Baseline|Olaparib + Ceralasertib|Randomized patients received ceralasertib 160 mg once daily (OD) from Days 1 to 7 and olaparib 300 mg twice daily (28-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met.
11381613|NCT03330847|BG002|Baseline|Olaparib + Adavosertib|Randomized patients received adavosertib 150 mg BD from days 1 to 3 and days 8 to 10 and olaparib 200 mg BD (21-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met. The adavosertib dose was reduced from 175 mg to 150 mg BD through implementation of clinical study protocol (CSP) version 5.0.
11381614|NCT03330847|BG003|Baseline|Total|Total of all reporting groups
11381615|NCT03330847|FG000|Participant Flow|Olaparib Monotherapy|Randomized patients received olaparib monotherapy 300 mg twice daily (BD) [28-day cycle], until objective radiological disease progression as per Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1) as assessed by the Investigator or until any other discontinuation criteria were met.
11381616|NCT03330847|FG001|Participant Flow|Olaparib + Ceralasertib|Randomized patients received ceralasertib 160 mg once daily (OD) from Days 1 to 7 and olaparib 300 mg twice daily (28-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met.
11381617|NCT03330847|FG002|Participant Flow|Olaparib + Adavosertib|Randomized patients received adavosertib 150 mg BD from days 1 to 3 and days 8 to 10 and olaparib 200 mg BD (21-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met. The adavosertib dose was reduced from 175 mg to 150 mg BD through implementation of clinical study protocol (CSP) version 5.0.
11381618|NCT03330847|OG000|Outcome|Olaparib Monotherapy|Randomized patients received olaparib monotherapy 300 mg twice daily (BD) [28-day cycle], until objective radiological disease progression as per Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1) as assessed by the Investigator or until any other discontinuation criteria were met.
10784963|NCT02385045|BG000|Baseline|Narrow Band Imaging|"Narrow band imaging function (Olympus endoscopes)~narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes"
10784964|NCT02385045|FG000|Participant Flow|Narrow Band Imaging|"Narrow band imaging function (Olympus endoscopes)~narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes"
10784965|NCT02385045|OG000|Outcome|Narrow Band Imaging|"Narrow band imaging function (Olympus endoscopes)~narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes"
10784966|NCT02385045|EG000|Reported Event|Narrow Band Imaging|"Narrow band imaging function (Olympus endoscopes)~narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes"
10784967|NCT02373241|BG000|Baseline|Standard Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <95th percentile~Losartan: Standard dosing"
10784968|NCT02373241|BG001|Baseline|Experimental Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <75th percentile~Losartan: Experimental dosing"
10784969|NCT02373241|BG002|Baseline|Total|Total of all reporting groups
10784970|NCT02373241|FG000|Participant Flow|Standard Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <95th percentile~Losartan: Standard dosing"
10784971|NCT02373241|FG001|Participant Flow|Experimental Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <75th percentile~Losartan: Experimental dosing"
10784972|NCT02373241|OG000|Outcome|Standard Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <95th percentile~Losartan: Standard dosing"
10784973|NCT02373241|OG001|Outcome|Experimental Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <75th percentile~Losartan: Experimental dosing"
11241013|NCT02483975|OG000|Outcome|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10784974|NCT02373241|EG000|Reported Event|Standard Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <95th percentile~Losartan: Standard dosing"
10784975|NCT02373241|EG001|Reported Event|Experimental Blood Pressure Management|"Participants initiated on 25mg of losartan daily and randomized to lower in-clinic BP to <75th percentile~Losartan: Experimental dosing"
10784976|NCT01845649|BG000|Baseline|Vehicle (3 Times/Week)|Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784977|NCT01845649|BG001|Baseline|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784978|NCT01845649|BG002|Baseline|Total|Total of all reporting groups
10784979|NCT01845649|FG000|Participant Flow|Vehicle (3 Times/Week)|Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784980|NCT01845649|FG001|Participant Flow|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784981|NCT01845649|OG000|Outcome|Vehicle (3 Times/Week)|Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784982|NCT01845649|OG001|Outcome|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784983|NCT01845649|EG000|Reported Event|Vehicle (3 Times/Week)|Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784984|NCT01845649|EG001|Reported Event|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
10784985|NCT01844986|BG000|Baseline|Olaparib 300mg Tablets|Taken orally twice daily
10784986|NCT01844986|BG001|Baseline|Placebo Tablets|Taken orally twice daily
10784987|NCT01844986|BG002|Baseline|Total|Total of all reporting groups
10784988|NCT01844986|FG000|Participant Flow|Olaparib 300mg Tablets|Taken orally twice daily
10784989|NCT01844986|FG001|Participant Flow|Placebo Tablets|Taken orally twice daily
10784990|NCT01844986|OG000|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
10784991|NCT01844986|OG001|Outcome|Placebo Tablets|Taken orally twice daily
10784992|NCT01844986|EG000|Reported Event|Olaparib 300 Tablets|Taken orally twice daily
10784993|NCT01844986|EG001|Reported Event|Placebo Tablets|Taken orally twice daily
10784994|NCT01816139|BG000|Baseline|Vehicle (2 Times/Week)|Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
10784995|NCT01816139|BG001|Baseline|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
10784996|NCT01816139|BG002|Baseline|Total|Total of all reporting groups
10784997|NCT01816139|FG000|Participant Flow|Vehicle (2 Times/Week)|Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
10784998|NCT01816139|FG001|Participant Flow|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
11381619|NCT03330847|OG001|Outcome|Olaparib + Ceralasertib|Randomized patients received ceralasertib 160 mg once daily (OD) from Days 1 to 7 and olaparib 300 mg twice daily (28-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met.
11381620|NCT03330847|OG002|Outcome|Olaparib + Adavosertib|Randomized patients received adavosertib 150 mg BD from days 1 to 3 and days 8 to 10 and olaparib 200 mg BD (21-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met. The adavosertib dose was reduced from 175 mg to 150 mg BD through implementation of clinical study protocol (CSP) version 5.0.
11381621|NCT03330847|OG000|Outcome|Olaparib + Ceralasertib|Randomized patients received ceralasertib 160 mg once daily (OD) from Days 1 to 7 and olaparib 300 mg twice daily (28-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met.
11381622|NCT03330847|OG001|Outcome|Olaparib + Adavosertib|Randomized patients received adavosertib 150 mg BD from days 1 to 3 and days 8 to 10 and olaparib 200 mg BD (21-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met. The adavosertib dose was reduced from 175 mg to 150 mg BD through implementation of clinical study protocol (CSP) version 5.0.
11381623|NCT03330847|EG000|Reported Event|Olaparib Monotherapy|Randomized patients received olaparib monotherapy 300 mg twice daily (BD) [28-day cycle], until objective radiological disease progression as per Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1) as assessed by the Investigator or until any other discontinuation criteria were met.
11381624|NCT03330847|EG001|Reported Event|Olaparib + Ceralasertib|Randomized patients received ceralasertib 160 mg once daily (OD) from Days 1 to 7 and olaparib 300 mg twice daily (28-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met.
11381625|NCT03330847|EG002|Reported Event|Olaparib + Adavosertib|Randomized patients received adavosertib 150 mg BD from days 1 to 3 and days 8 to 10 and olaparib 200 mg BD (21-day cycle), until objective radiological disease progression as per RECIST 1.1 as assessed by the Investigator or until any other discontinuation criteria were met. The adavosertib dose was reduced from 175 mg to 150 mg BD through implementation of clinical study protocol (CSP) version 5.0.
11381626|NCT03283241|BG000|Baseline|Zolidd One ExHex|"Coated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381627|NCT03283241|BG001|Baseline|One ExHex|"Uncoated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381628|NCT03283241|BG002|Baseline|Total|Total of all reporting groups
11381629|NCT03283241|FG000|Participant Flow|Zolidd One ExHex|"Coated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381630|NCT03283241|FG001|Participant Flow|One ExHex|"Uncoated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381631|NCT03283241|OG000|Outcome|Zolidd One ExHex|"Coated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381632|NCT03283241|OG001|Outcome|One ExHex|"Uncoated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381633|NCT03283241|EG000|Reported Event|Zolidd One ExHex|"Coated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381634|NCT03283241|EG001|Reported Event|One ExHex|"Uncoated titanium implant~Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.~One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
11381635|NCT03242772|BG000|Baseline|ESDM Informed Parent Coaching + Amphetamine|"Amphetamine regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The drug is an orally dissolvable, extended-release form of d- and l-amphetamine.~Amphetamine: Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts)."
11381636|NCT03242772|BG001|Baseline|ESDM Informed Parent Coaching + Placebo Oral Tablet|"Placebo regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The placebo contains no active drug and appears identical to the amphetamine (active drug).~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).~Placebo Oral Tablet: Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time."
11381637|NCT03242772|BG002|Baseline|Total|Total of all reporting groups
11381638|NCT03242772|FG000|Participant Flow|ESDM Informed Parent Coaching + Amphetamine|"Amphetamine regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The drug is an orally dissolvable, extended-release form of d- and l-amphetamine.~Amphetamine: Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts)."
11381639|NCT03242772|FG001|Participant Flow|ESDM Informed Parent Coaching + Placebo Oral Tablet|"Placebo regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The placebo contains no active drug and appears identical to the amphetamine (active drug).~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).~Placebo Oral Tablet: Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time."
11381640|NCT03242772|OG000|Outcome|ESDM Informed Parent Coaching + Amphetamine|"Amphetamine regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The drug is an orally dissolvable, extended-release form of d- and l-amphetamine.~Amphetamine: Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts)."
11381641|NCT03242772|OG001|Outcome|ESDM Informed Parent Coaching + Placebo Oral Tablet|"Placebo regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The placebo contains no active drug and appears identical to the amphetamine (active drug).~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).~Placebo Oral Tablet: Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time."
11381642|NCT03242772|EG000|Reported Event|ESDM Informed Parent Coaching + Amphetamine|"Amphetamine regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The drug is an orally dissolvable, extended-release form of d- and l-amphetamine.~Amphetamine: Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts)."
10784999|NCT01816139|OG000|Outcome|Vehicle (2 Times/Week)|Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
10785000|NCT01816139|OG001|Outcome|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
11381643|NCT03242772|EG001|Reported Event|ESDM Informed Parent Coaching + Placebo Oral Tablet|"Placebo regimen (11 weeks total duration) will begin 2 weeks prior to initiation of ESDM informed parent coaching (8 weekly sessions) and continue through the week 11 endpoint assessment. The placebo contains no active drug and appears identical to the amphetamine (active drug).~ESDM informed parent coaching: All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).~Placebo Oral Tablet: Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time."
11381644|NCT03236311|BG000|Baseline|Placebo|Matching placebo for 4 weeks.
11381645|NCT03236311|BG001|Baseline|SAR407899|SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
11241014|NCT02483975|OG001|Outcome|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11381646|NCT03236311|BG002|Baseline|Total|Total of all reporting groups
11381647|NCT03236311|FG000|Participant Flow|Placebo|Matching placebo for 4 weeks.
11381648|NCT03236311|FG001|Participant Flow|SAR407899|SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
11381649|NCT03236311|OG000|Outcome|Placebo|Matching placebo for 4 weeks.
11381650|NCT03236311|OG001|Outcome|SAR407899|SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
11381651|NCT03236311|EG000|Reported Event|Placebo|Matching placebo for 4 weeks.
11381652|NCT03236311|EG001|Reported Event|SAR407899|SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
11381653|NCT03192046|BG000|Baseline|Carbon Fiber Ankle Foot Orthosis (AFO)|"For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week."
11381654|NCT03192046|BG001|Baseline|Control Group, Walking Program Only|"The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week."
11381655|NCT03192046|BG002|Baseline|Total|Total of all reporting groups
11381656|NCT03192046|FG000|Participant Flow|Carbon Fiber Ankle Foot Orthosis (AFO)|"For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week."
10785001|NCT01816139|EG000|Reported Event|Vehicle (2 Times/Week)|Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
10785002|NCT01816139|EG001|Reported Event|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
11381657|NCT03192046|FG001|Participant Flow|Control Group, Walking Program Only|The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
11381658|NCT03192046|OG000|Outcome|Carbon Fiber Ankle Foot Orthosis (AFO)|"For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week."
11381659|NCT03192046|OG001|Outcome|Control Group, Walking Program Only|"The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week."
11381660|NCT03192046|EG000|Reported Event|Carbon Fiber Ankle Foot Orthosis (AFO)|"For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.~There were not any adverse events"
11381661|NCT03192046|EG001|Reported Event|Control Group, Walking Program Only|"The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.~Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.~There were not any adverse events"
11381662|NCT03190369|BG000|Baseline|Placebo|Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.
11381663|NCT03190369|BG001|Baseline|Hylan G-F 20|Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.
11381664|NCT03190369|BG002|Baseline|Total|Total of all reporting groups
11381665|NCT03190369|FG000|Participant Flow|Placebo|Participants received a single intra-articular (IA) injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.
11381666|NCT03190369|FG001|Participant Flow|Hylan G-F 20|Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.
11381667|NCT03190369|OG000|Outcome|Placebo|Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.
11381668|NCT03190369|OG001|Outcome|Hylan G-F 20|Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.
11381669|NCT03190369|EG000|Reported Event|Placebo|Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.
11381670|NCT03190369|EG001|Reported Event|Hylan G-F 20|Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.
10785003|NCT01455597|BG000|Baseline|WC3011 Estradiol Vaginal Cream|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks.
10785004|NCT01455597|FG000|Participant Flow|Previous WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream. applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC3011 estradiol vaginal cream 2 times a week in the previous study were included in this arm group).
10785005|NCT01455597|FG001|Participant Flow|Previous Vehicle (2 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 2 times a week in the previous study were included in this arm group).
10785006|NCT01455597|FG002|Participant Flow|Previous WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group).
10785007|NCT01455597|FG003|Participant Flow|Previous Vehicle (3 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group).
10785008|NCT01455597|OG000|Outcome|WC3011 Estradiol Vaginal Cream: Less Than 92 Days|WC3011 estradiol vaginal cream applied vaginally 3 times a week for a median exposure of less than 92 days.
10785009|NCT01455597|OG001|Outcome|WC3011 Estradiol Vaginal Cream: 92-182 Days|WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of 92 to 182 days.
10785010|NCT01455597|OG002|Outcome|WC3011 Estradiol Vaginal Cream: 183-273 Days|WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of 183 to 273 days.
10785011|NCT01455597|OG003|Outcome|WC3011 Estradiol Vaginal Cream: More Than 273 Days|WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of more than 273 days.
10785012|NCT01455597|OG000|Outcome|Previous WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream. applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC3011 estradiol vaginal cream 2 times a week in the previous study were included in this arm group).
10785013|NCT01455597|OG001|Outcome|Previous Vehicle (2 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 2 times a week in the previous study were included in this arm group).
10785014|NCT01455597|OG002|Outcome|Previous WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group).
10785015|NCT01455597|OG003|Outcome|Previous Vehicle (3 Times/Week)|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group).
10785016|NCT01455597|OG000|Outcome|WC3011 Estradiol Vaginal Cream|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks.
10785017|NCT01455597|EG000|Reported Event|WC3011 Estradiol Vaginal Cream|WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks.
10785018|NCT01400776|BG000|Baseline|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785019|NCT01400776|BG001|Baseline|Vehicle (2 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785020|NCT01400776|BG002|Baseline|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785021|NCT01400776|BG003|Baseline|Vehicle (3 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785022|NCT01400776|BG004|Baseline|Total|Total of all reporting groups
10785023|NCT01400776|FG000|Participant Flow|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785024|NCT01400776|FG001|Participant Flow|Vehicle (2 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785025|NCT01400776|FG002|Participant Flow|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785026|NCT01400776|FG003|Participant Flow|Vehicle (3 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785027|NCT01400776|OG000|Outcome|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785028|NCT01400776|OG001|Outcome|Vehicle (2 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785029|NCT01400776|OG002|Outcome|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785030|NCT01400776|OG003|Outcome|Vehicle (3 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785031|NCT01400776|EG000|Reported Event|WC3011 Estradiol Vaginal Cream (2 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785032|NCT01400776|EG001|Reported Event|Vehicle (2 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
10785033|NCT01400776|EG002|Reported Event|WC3011 Estradiol Vaginal Cream (3 Times/Week)|WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785034|NCT01400776|EG003|Reported Event|Vehicle (3 Times/Week)|Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
10785035|NCT01194570|BG000|Baseline|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
10785036|NCT01194570|BG001|Baseline|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
10785037|NCT01194570|BG002|Baseline|Total|Total of all reporting groups
10785038|NCT01194570|FG000|Participant Flow|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
11194436|NCT02152345|BG001|Baseline|Standard Immunosuppression (Tacrolimus)|"Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL.~Standard of Care:~Tacrolimus 6 - 8 ng/mL administered daily thereafter until end of study.~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3."
11194437|NCT02152345|BG002|Baseline|Total|Total of all reporting groups
11381671|NCT04657198|BG000|Baseline|High Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381672|NCT04657198|BG001|Baseline|Low Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381673|NCT04657198|BG002|Baseline|Medium Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381674|NCT04657198|BG003|Baseline|Total|Total of all reporting groups
11381675|NCT04657198|FG000|Participant Flow|High Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381676|NCT04657198|FG001|Participant Flow|Low Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381677|NCT04657198|FG002|Participant Flow|Medium Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381678|NCT04657198|OG000|Outcome|High Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381679|NCT04657198|OG001|Outcome|Low Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381680|NCT04657198|OG002|Outcome|Medium Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381681|NCT04657198|EG000|Reported Event|High Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381682|NCT04657198|EG001|Reported Event|Low Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
10785039|NCT01194570|FG001|Participant Flow|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
10785040|NCT01194570|OG000|Outcome|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
11241015|NCT02483975|EG000|Reported Event|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11381683|NCT04657198|EG002|Reported Event|Medium Dose_AS01E Group|Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
11381684|NCT04590586|BG000|Baseline|Lanadelumab + Standard of Care|Participants randomized to receive lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4, in addition to standard of care.
11381685|NCT04590586|BG001|Baseline|Lanadelumab Placebo Control|Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.
11381686|NCT04590586|BG002|Baseline|Apremilast + Standard of Care|Participants randomized to receive 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381687|NCT04590586|BG003|Baseline|Apremilast Placebo Control|Includes participants randomized to receive matching placebo to apremilast plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to zilucoplan plus standard of care treatment at a site concurrently enrolling apremilast sub-protocol participants and who would have been eligible for the apremilast sub-protocol.
11381688|NCT04590586|BG004|Baseline|Zilucoplan + Standard of Care|Participants randomized to receive 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
10785041|NCT01194570|OG001|Outcome|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
10785042|NCT01194570|EG000|Reported Event|Placebo|Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
10785043|NCT01194570|EG001|Reported Event|Ocrelizumab 600 mg|Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
10785044|NCT00511134|BG000|Baseline|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
10785045|NCT00511134|BG001|Baseline|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
10785046|NCT00511134|BG002|Baseline|Total|Total of all reporting groups
10785047|NCT00511134|FG000|Participant Flow|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
10785048|NCT00511134|FG001|Participant Flow|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
10785049|NCT00511134|OG000|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
11381689|NCT04590586|BG005|Baseline|Zilucoplan Placebo +Control|Includes participants randomized to receive matching placebo to zilucoplan plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to apremilast plus standard of care treatment at a site that enrolled at least one participant in the zilucoplan sub-protocol.
11241016|NCT02483975|EG001|Reported Event|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
10785050|NCT00511134|OG001|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
10785051|NCT00511134|EG000|Reported Event|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
10785052|NCT00511134|EG001|Reported Event|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
10785053|NCT00349466|BG000|Baseline|CF101 1 mg|CF101 1 mg q12 hours
10785054|NCT00349466|BG001|Baseline|Placebo|Placebo tablets q12 hours for 12 weeks
10785055|NCT00349466|BG002|Baseline|Total|Total of all reporting groups
10785056|NCT00349466|FG000|Participant Flow|CF101 1 mg|CF101 1 mg q12 hours
10785057|NCT00349466|FG001|Participant Flow|Placebo|Placebo tablets q12 hours for 12 weeks
10785058|NCT00349466|OG000|Outcome|CF101 1 mg|Oral tablets given every 12 hours for 12 weeks
10785059|NCT00349466|OG001|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
10785060|NCT00349466|OG000|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
10785061|NCT00349466|OG001|Outcome|Placebo BID|Oral tablets given every 12 hours for 12 weeks
10785062|NCT00349466|EG000|Reported Event|CF101 1 mg|CF101 1 mg q12 hours
10785063|NCT00349466|EG001|Reported Event|Placebo|Placebo tablets q12 hours for 12 weeks
10964643|NCT00878553|OG001|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10 mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
10964644|NCT00878553|OG000|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
11381690|NCT04590586|BG006|Baseline|Total|Total of all reporting groups
11381691|NCT04590586|FG000|Participant Flow|Lanadelumab + Standard of Care|Participants randomized to receive lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4, in addition to standard of care.
10785073|NCT03894540|BG000|Baseline|IPN60090 20 mg|Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
10785074|NCT03894540|BG001|Baseline|IPN60090 40 mg|Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
10785075|NCT03894540|BG002|Baseline|IPN60090 80 mg|Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
10785076|NCT03894540|BG003|Baseline|IPN60090 120 mg|Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785077|NCT03894540|BG004|Baseline|IPN60090 180 mg|Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785078|NCT03894540|BG005|Baseline|IPN60090 240 mg|Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
10785079|NCT03894540|BG006|Baseline|Total|Total of all reporting groups
10785080|NCT03894540|FG000|Participant Flow|IPN60090 20 mg|Participants received IPN60090 20 milligram (mg) capsules orally twice daily (BID) up to Cycle 7 in Part A of the study.
10785081|NCT03894540|FG001|Participant Flow|IPN60090 40 mg|Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
10785082|NCT03894540|FG002|Participant Flow|IPN60090 80 mg|Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
10785083|NCT03894540|FG003|Participant Flow|IPN60090 120 mg|Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785084|NCT03894540|FG004|Participant Flow|IPN60090 180 mg|Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785085|NCT03894540|FG005|Participant Flow|IPN60090 240 mg|Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
10785086|NCT03894540|OG000|Outcome|IPN60090 20 mg|Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
10785087|NCT03894540|OG001|Outcome|IPN60090 40 mg|Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
10785088|NCT03894540|OG002|Outcome|IPN60090 80 mg|Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
10785089|NCT03894540|OG003|Outcome|IPN60090 120 mg|Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785090|NCT03894540|OG004|Outcome|IPN60090 180 mg|Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785091|NCT03894540|OG005|Outcome|IPN60090 240 mg|Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
10785092|NCT03894540|OG000|Outcome|DLT Evaluable Population Analysis Set|DLT evaluable population included all participants from the safety population who were evaluable for DLT (participants who completed at least one cycle of treatment and received ≥75% of the total planned dose of IPN60090 over the DLT assessment period).
10785093|NCT03894540|OG000|Outcome|IPN60090 120 mg|Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785094|NCT03894540|OG001|Outcome|IPN60090 180 mg|Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785095|NCT03894540|OG002|Outcome|IPN60090 240 mg|Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
10785096|NCT03894540|EG000|Reported Event|IPN60090 20 mg|Participants received IPN60090 20 mg capsules orally BID up to Cycle 7 in Part A of the study.
10785097|NCT03894540|EG001|Reported Event|IPN60090 40 mg|Participants received IPN60090 40 mg capsules orally BID up to Cycle 2 in Part A of the study.
10785098|NCT03894540|EG002|Reported Event|IPN60090 80 mg|Participants received IPN60090 80 mg capsules orally BID up to Cycle 5 in Part A of the study.
10785099|NCT03894540|EG003|Reported Event|IPN60090 120 mg|Participants received IPN60090 120 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785100|NCT03894540|EG004|Reported Event|IPN60090 180 mg|Participants received IPN60090 180 mg capsules orally BID up to Cycle 9 in Part A of the study.
10785101|NCT03894540|EG005|Reported Event|IPN60090 240 mg|Participants received IPN60090 240 mg capsules orally BID up to Cycle 4 in Part A of the study.
10785102|NCT03816202|BG000|Baseline|Sundt Carotid Shunt|Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
10785103|NCT03816202|FG000|Participant Flow|Sundt Carotid Shunt|Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
10785104|NCT03816202|OG000|Outcome|Sundt Carotid Shunt|Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt
10785105|NCT03816202|EG000|Reported Event|Sundt Carotid Shunt|number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal
10785106|NCT03725293|BG000|Baseline|Angiodynamics BioFlo Midline Catheter|"Placement of clinically indicated Angiodynamics BioFlo midline catheter.~Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter."
10785107|NCT03725293|BG001|Baseline|Teleflex Arrowg+Ard Blue Advanced Midline Catheter|"Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter~Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter."
10785108|NCT03725293|BG002|Baseline|Total|Total of all reporting groups
10785109|NCT03725293|FG000|Participant Flow|Angiodynamics BioFlo Midline Catheter|"Placement of clinically indicated Angiodynamics BioFlo midline catheter.~Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter."
10785110|NCT03725293|FG001|Participant Flow|Teleflex Arrowg+Ard Blue Advanced Midline Catheter|"Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter~Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter."
10785111|NCT03725293|OG000|Outcome|Angiodynamics BioFlo Midline Catheter|"Placement of clinically indicated Angiodynamics BioFlo midline catheter.~Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter."
10785112|NCT03725293|OG001|Outcome|Teleflex Arrowg+Ard Blue Advanced Midline Catheter|"Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter~Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter."
10785113|NCT03725293|EG000|Reported Event|Angiodynamics BioFlo Midline Catheter|"Placement of clinically indicated Angiodynamics BioFlo midline catheter.~Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter."
10785114|NCT03725293|EG001|Reported Event|Teleflex Arrowg+Ard Blue Advanced Midline Catheter|"Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter~Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter."
10785115|NCT03702231|BG000|Baseline|Chronic Lymphocytic Leukemia Patients That Are Treatment Naive|"Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785116|NCT03702231|BG001|Baseline|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785117|NCT03702231|BG002|Baseline|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785118|NCT03702231|BG003|Baseline|Total|Total of all reporting groups
10785119|NCT03702231|FG000|Participant Flow|Chronic Lymphocytic Leukemia Patients That Are Treatment Naive|"Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785120|NCT03702231|FG001|Participant Flow|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785121|NCT03702231|FG002|Participant Flow|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785122|NCT03702231|OG000|Outcome|Chronic Lymphocytic Leukemia Patients That Are Treatment Naive|"Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785123|NCT03702231|OG001|Outcome|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785124|NCT03702231|OG002|Outcome|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785125|NCT03702231|EG000|Reported Event|Chronic Lymphocytic Leukemia Patients That Are Treatment Naive|"Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785126|NCT03702231|EG001|Reported Event|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785127|NCT03702231|EG002|Reported Event|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|"Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.~Zoster Vaccine Recombinant, Adjuvanted: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection."
10785128|NCT03690284|BG000|Baseline|Conventional Double Lumen Tube|"Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.~Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery"
10785129|NCT03690284|BG001|Baseline|VivaSight Double Lumen Tube|"Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.~VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery"
10785130|NCT03690284|BG002|Baseline|Total|Total of all reporting groups
10785131|NCT03690284|FG000|Participant Flow|Conventional Double Lumen Tube|"Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.~Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery"
10785132|NCT03690284|FG001|Participant Flow|VivaSight Double Lumen Tube|"Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.~VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery"
10785133|NCT03690284|OG000|Outcome|Conventional Double Lumen Tube|"Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.~Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery"
10785134|NCT03690284|OG001|Outcome|VivaSight Double Lumen Tube|"Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.~VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery"
10785135|NCT03690284|EG000|Reported Event|Conventional Double Lumen Tube|"Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.~Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery"
10785136|NCT03690284|EG001|Reported Event|VivaSight Double Lumen Tube|"Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.~VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery"
10785137|NCT03670277|BG000|Baseline|Test|Subjects were fit with the Test lens at Visit 2 of the study
10785138|NCT03670277|BG001|Baseline|Control|Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline.
10785139|NCT03670277|BG002|Baseline|Total|Total of all reporting groups
10785140|NCT03670277|FG000|Participant Flow|Test|Subjects were fit with the Test lens at Visit 2 of the study
10785141|NCT03670277|FG001|Participant Flow|Control|Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline.
10785142|NCT03670277|OG000|Outcome|Test|Subjects who have >=5mm pupil size were fit with the Test lens at Visit 2 of the study
10785143|NCT03670277|OG001|Outcome|Control|Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline.
10785144|NCT03670277|OG001|Outcome|Control|Existing Orthokeratology patients who have >=5mm pupil size at Visit1 Baseline
10785145|NCT03670277|OG000|Outcome|Test|Subjects were fit with the Test lens at Visit 2 of the study
10785146|NCT03670277|OG001|Outcome|Control|Existing Orthokeratology patients at Visit 1 Baseline
10785147|NCT03670277|EG000|Reported Event|Test|Subjects were fit with the Test lens at Visit 2 of the study
10964645|NCT00878553|OG001|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
10964646|NCT00878553|OG002|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
10785148|NCT03670277|EG001|Reported Event|Control|Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline.
10785149|NCT03556358|BG000|Baseline|TX05 (Trastuzumab)|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785150|NCT03556358|BG001|Baseline|Herceptin®|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~Herceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785151|NCT03556358|BG002|Baseline|Total|Total of all reporting groups
10785152|NCT03556358|FG000|Participant Flow|TX05 (Trastuzumab)|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785153|NCT03556358|FG001|Participant Flow|Herceptin®|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~Herceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785154|NCT03556358|OG000|Outcome|TX05 (Trastuzumab)|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785155|NCT03556358|OG001|Outcome|Herceptin®|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~Herceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785156|NCT03556358|EG000|Reported Event|TX05 (Trastuzumab)|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10785157|NCT03556358|EG001|Reported Event|Herceptin®|"• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles~Followed by:~• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles~Herceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)~Paclitaxel: 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)~Epirubicin: 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)~Cyclophosphamide: 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)"
10802048|NCT03172780|EG001|Reported Event|Voltaren® Gel|"Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%~Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks"
10785158|NCT03290781|BG000|Baseline|ONTA 25mg/ Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785159|NCT03290781|BG001|Baseline|ONTA 25mg/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785160|NCT03290781|BG002|Baseline|ONTA 75mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785161|NCT03290781|BG003|Baseline|ONTA 75mg/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785162|NCT03290781|BG004|Baseline|Placebo/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785163|NCT03290781|BG005|Baseline|Placebo/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785164|NCT03290781|BG006|Baseline|Placebo/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785165|NCT03290781|BG007|Baseline|Total|Total of all reporting groups
10785166|NCT03290781|FG000|Participant Flow|ONTA 25mg/ Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
10785167|NCT03290781|FG001|Participant Flow|ONTA 25mg/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785168|NCT03290781|FG002|Participant Flow|ONTA 75mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785169|NCT03290781|FG003|Participant Flow|ONTA 75mg/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785170|NCT03290781|FG004|Participant Flow|Placebo/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785171|NCT03290781|FG005|Participant Flow|Placebo/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785172|NCT03290781|FG006|Participant Flow|Placebo/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785173|NCT03290781|OG000|Outcome|ONTA 25 mg/ Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785174|NCT03290781|OG001|Outcome|ONTA 25 mg/ONTA 25 mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785175|NCT03290781|OG002|Outcome|ONTA 75 mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785176|NCT03290781|OG003|Outcome|ONTA 75 mg/ONTA 75 mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785177|NCT03290781|OG000|Outcome|ONTA 25mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785178|NCT03290781|OG001|Outcome|ONTA 25mg/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10802049|NCT03172780|EG002|Reported Event|Placebo Gel|"Placebo gel~Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks"
10785179|NCT03290781|OG002|Outcome|ONTA 75mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785180|NCT03290781|OG003|Outcome|ONTA 75mg/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785181|NCT03290781|OG000|Outcome|ONTA 25mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785182|NCT03290781|OG000|Outcome|ONTA 25mg/ Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
10785183|NCT03290781|OG000|Outcome|ONTA 25mg/Placebo|PParticipants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785184|NCT03290781|OG004|Outcome|Placebo/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785185|NCT03290781|OG005|Outcome|Placebo/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785186|NCT03290781|OG006|Outcome|Placebo/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785187|NCT03290781|EG000|Reported Event|ONTA 25mg/ Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 milligram (mg) of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
10785188|NCT03290781|EG001|Reported Event|ONTA 25mg/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785189|NCT03290781|EG002|Reported Event|ONTA 75mg/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785190|NCT03290781|EG003|Reported Event|ONTA 75mg/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785191|NCT03290781|EG004|Reported Event|Placebo/Placebo|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785192|NCT03290781|EG005|Reported Event|Placebo/ONTA 25mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785193|NCT03290781|EG006|Reported Event|Placebo/ONTA 75mg|Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
10785194|NCT03263195|BG000|Baseline|Women With HIV Only|Pregnant women with HIV infection only
10785195|NCT03263195|BG001|Baseline|Women With ZIKV Only|Pregnant women with ZIKV infection only
10785196|NCT03263195|BG002|Baseline|Women With HIV and ZIKV|Pregnant women with HIV and ZIKV infection
10785197|NCT03263195|BG003|Baseline|Women Without HIV or ZIKV|Pregnant women without HIV or ZIKV infection
10785198|NCT03263195|BG004|Baseline|Total|Total of all reporting groups
10785199|NCT03263195|FG000|Participant Flow|Women With HIV Only|Pregnant women with HIV infection only
10785200|NCT03263195|FG001|Participant Flow|Women With ZIKV Only|Pregnant women with ZIKV infection only
10785201|NCT03263195|FG002|Participant Flow|Women With HIV and ZIKV|Pregnant women with HIV and ZIKV infection
10785202|NCT03263195|FG003|Participant Flow|Women Without HIV or ZIKV|Pregnant women without HIV or ZIKV infection
10785203|NCT03263195|FG004|Participant Flow|Infants of Women With HIV Only|Infants of women with HIV infection during pregnancy
10785204|NCT03263195|FG005|Participant Flow|Infants of Women With ZIKV Only|Infants of women with ZIKV infection during pregnancy
10785205|NCT03263195|FG006|Participant Flow|Infants of Women With HIV and ZIKV|Infants of women with HIV and ZIKV infection during pregnancy
10785206|NCT03263195|FG007|Participant Flow|Infants of Women Without HIV or ZIKV|Infants of women without HIV or ZIKV infection during pregnancy
10785207|NCT03263195|OG000|Outcome|Women With HIV Only|Pregnant women with HIV infection only
10785208|NCT03263195|OG001|Outcome|Women With ZIKV Only|Pregnant women ZIKV infection only
10785209|NCT03263195|OG002|Outcome|Women With HIV and ZIKV|Pregnant women with HIV and ZIKV infection
10785210|NCT03263195|OG003|Outcome|Women Without HIV or ZIKV|Pregnant women without HIV or ZIKV infection
10785211|NCT03263195|OG001|Outcome|Women With HIV and ZIKV|Pregnant women with HIV and ZIKV infection
10785212|NCT03263195|OG000|Outcome|Women With HIV|Pregnant women with HIV infection
10785213|NCT03263195|OG001|Outcome|Women Without HIV|Pregnant women without HIV infection
10785214|NCT03263195|OG001|Outcome|Women With ZIKV Only|Pregnant women with ZIKV infection only
10785215|NCT03263195|OG000|Outcome|Infants of Women With HIV Only|Infants of women with HIV during pregnancy
10785216|NCT03263195|OG001|Outcome|Infants of Women With ZIKV Only|Infants of women with ZIKV infection during pregnancy
10785217|NCT03263195|OG002|Outcome|Infants of Women With HIV and ZIKV|Infants of women with HIV and ZIKV infection during pregnancy
10964647|NCT00878553|EG000|Reported Event|Placebo|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
10785218|NCT03263195|OG000|Outcome|Infants of Women With HIV Only|Infants of women with HIV infection during pregnancy
10785219|NCT03263195|OG003|Outcome|Infants of Women Without HIV or ZIKV|Infants of women without HIV or ZIKV infection during pregnancy
10785220|NCT03263195|EG000|Reported Event|Women With HIV Only|Pregnant women with HIV only
10785221|NCT03263195|EG001|Reported Event|Women With ZIKV Only|Pregnant women with ZIKV only
10785222|NCT03263195|EG002|Reported Event|Women With HIV and ZIKV|Pregnant women with HIV and ZIKV
10785223|NCT03263195|EG003|Reported Event|Women Without HIV or ZIKV|Pregnant women without HIV or ZIKV
10785224|NCT03263195|EG004|Reported Event|Infants of Women With HIV Only|Infants of women with HIV infection during pregnancy
10785225|NCT03263195|EG005|Reported Event|Infants of Women With ZIKV Only|Infants of women with ZIKV infection during pregnancy
10785226|NCT03263195|EG006|Reported Event|Infants of Women With HIV and ZIKV|Infants of women with HIV and ZIKV infection during pregnancy
10785227|NCT03263195|EG007|Reported Event|Infants of Women Without HIV or ZIKV|Infants of women without HIV or ZIKV infection during pregnancy
10785228|NCT03228680|BG000|Baseline|FE 999049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10964648|NCT00878553|EG001|Reported Event|10 mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
10785229|NCT03228680|BG001|Baseline|FOLLISTIM (Follitropin Beta)|FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785230|NCT03228680|BG002|Baseline|Total|Total of all reporting groups
10785231|NCT03228680|FG000|Participant Flow|FE 999049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785232|NCT03228680|FG001|Participant Flow|FOLLISTIM (Follitropin Beta)|FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785233|NCT03228680|OG000|Outcome|FE 999049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785234|NCT03228680|OG001|Outcome|FOLLISTIM (Follitropin Beta)|FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785235|NCT03228680|OG000|Outcome|FOLLISTIM (Follitropin Beta)|FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785236|NCT03228680|EG000|Reported Event|FE 999049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10964649|NCT00878553|EG002|Reported Event|15mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
11381692|NCT04590586|FG001|Participant Flow|Lanadelumab Placebo + Standard of Care|Participants randomized to receive placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
11381693|NCT04590586|FG002|Participant Flow|Apremilast + Standard of Care|Participants randomized to received 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381694|NCT04590586|FG003|Participant Flow|Apremilast Placebo + Standard of Care|Participants randomized to receive matching placebo to apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381695|NCT04590586|FG004|Participant Flow|Zilucoplan + Standard of Care|Participants randomized to receive 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381696|NCT04590586|FG005|Participant Flow|Zilucoplan Placebo + Standard of Care|Participants randomized to receive placebo to zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381697|NCT04590586|OG000|Outcome|Lanadelumab + Standard of Care|Participants randomized to receive lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4, in addition to standard of care.
11381698|NCT04590586|OG001|Outcome|Lanadelumab Placebo Control|Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.
11381699|NCT04590586|OG000|Outcome|Apremilast + Standard of Care|Participants randomized to receive 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381700|NCT04590586|OG001|Outcome|Apremilast Placebo Control|Includes participants randomized to receive matching placebo to apremilast plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to zilucoplan plus standard of care treatment at a site concurrently enrolling apremilast sub-protocol participants and who would have been eligible for the apremilast sub-protocol.
11381701|NCT04590586|OG000|Outcome|Zilucoplan + Standard of Care|Participants randomized to receive 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381702|NCT04590586|OG001|Outcome|Zilucoplan Placebo Control|Includes participants randomized to receive matching placebo to zilucoplan plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to apremilast plus standard of care treatment at a site that enrolled at least one participant in the zilucoplan sub-protocol.
11381703|NCT04590586|OG000|Outcome|Lanadelumab + Standard of Care|Participants received lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4, in addition to standard of care.
11381704|NCT04590586|OG001|Outcome|Lanadelumab Placebo Control|Includes participants who received matching placebo to lanadelumab plus standard of care treatment as well as participants who received placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.
11381705|NCT04590586|OG002|Outcome|Lanadelumab Placebo + Standard of Care|Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
11381706|NCT04590586|OG000|Outcome|Apremilast + Standard of Care|Participants randomized to receive 30 mg apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381707|NCT04590586|OG000|Outcome|Apremilast + Standard of Care|Participants received 30 mg apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381708|NCT04590586|OG001|Outcome|Apremilast Placebo Control|Includes participants who received matching placebo to apremilast plus standard of care treatment as well as participants who received placebo to lanadelumab or placebo to zilucoplan plus standard of care treatment at a site concurrently enrolling apremilast sub-protocol participants and who would have been eligible for the apremilast sub-protocol.
11381709|NCT04590586|OG002|Outcome|Apremilast Placebo + Standard of Care|Participants received matching placebo to apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
11381710|NCT04590586|OG000|Outcome|Zilucoplan+ Standard of Care|Participants received 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381711|NCT04590586|OG001|Outcome|Zilucoplan Placebo Control|Includes participants who received matching placebo to zilucoplan plus standard of care treatment as well as participants who received placebo to lanadelumab or placebo to apremilast plus standard of care treatment at a site that enrolled at least one participant in the zilucoplan sub-protocol.
11381712|NCT04590586|OG002|Outcome|Zilucoplan Placebo + Standard of Care|Participants received placebo to zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381713|NCT04590586|EG000|Reported Event|Lanadelumab + SoC|Participants received lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4, in addition to standard of care (SoC).
11381714|NCT04590586|EG001|Reported Event|Lanadelumab Placebo + SoC|Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
11381715|NCT04590586|EG002|Reported Event|Apremilast + SoC|Participants received 30 mg apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
10964650|NCT00878553|EG003|Reported Event|20mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
10785237|NCT03228680|EG001|Reported Event|FOLLISTIM (Follitropin Beta)|FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
10785238|NCT03196167|BG000|Baseline|Sugammadex|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Sugammadex: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785239|NCT03196167|BG001|Baseline|Placebo|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Placebo: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785240|NCT03196167|BG002|Baseline|Total|Total of all reporting groups
10785241|NCT03196167|FG000|Participant Flow|Sugammadex|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Sugammadex: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785242|NCT03196167|FG001|Participant Flow|Placebo|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Placebo: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785243|NCT03196167|OG000|Outcome|Sugammadex|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785244|NCT03196167|OG001|Outcome|Placebo|"Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.~Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy."
10785245|NCT03196167|OG000|Outcome|Sugammadex Group|Sugammadex Group: Study Group
10785246|NCT03196167|OG001|Outcome|Placebo Group|Placebo Group:Control Group
10785247|NCT03196167|OG000|Outcome|Sugammadex Group|Sugammadex Group:Study Group
10785248|NCT03196167|OG001|Outcome|Placebo Group|Placebo Group: Control Group
10785249|NCT03196167|EG000|Reported Event|Sugammadex|Patients received 2 mg/kg Sugammadex intravenously once in the postoperative period in a blinded fashion.
10785250|NCT03196167|EG001|Reported Event|Placebo|Patients received placebo intravenously once in the postoperative period in a blinded fashion.
10802050|NCT03151304|BG000|Baseline|Stage 1a and 1b Open-label Pracinostat Plus Azacitidine|"open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.~In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.~Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:~Schedule 1 - daily therapy on Days 1 through 7~Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle~Pracinostat: 45 mg capsule~Azacitidine: SC or IV injection"
11241017|NCT02484092|BG000|Baseline|SPK-9001 (5 x 10^11 vg/kg) IV Infusion|Participants were infused with 100 IU/kg of their usual FIX protein product over 10 minutes at Day 0 visit. Following the bolus infusion of the usual FIX protein product, the participant was infused with SPK-9001 (5 x 10^11 vg/kg) for approximately 60 minutes via infusion pump.
11381716|NCT04590586|EG003|Reported Event|Apremilast Placebo + SoC|Participants received matching placebo to apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.
10802051|NCT03151304|FG000|Participant Flow|Stage 1a and 1b Open-label Pracinostat Plus Azacitidine|"open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.~In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.~Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:~Schedule 1 - daily therapy on Days 1 through 7~Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle~Pracinostat: 45 mg capsule~Azacitidine: SC or IV injection"
10802052|NCT03151304|OG000|Outcome|Stage 1a and 1b Open-label Pracinostat Plus Azacitidine|"open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.~In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.~Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:~Schedule 1 - daily therapy on Days 1 through 7~Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle~Pracinostat: 45 mg capsule~Azacitidine: SC or IV injection"
10803754|NCT02134028|FG003|Participant Flow|Participants From EFC13579: Dupilumab/Dupilumab|Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10785251|NCT03077204|BG000|Baseline|BIO4 Treatment|Treatment group consisted of patient undergoing ACDF using BIO4
10785252|NCT03077204|FG000|Participant Flow|BIO4 Treatment|Participants were treated as per the protocol.
10785253|NCT03077204|OG000|Outcome|BIO4 Treatment|Patients undergoing ACDF using BIO4
10785254|NCT03077204|OG000|Outcome|BIO4 Treatment|9.1±2.4(0-36)
10785255|NCT03077204|EG000|Reported Event|BIO4 Treatment|Patients undergoing ACDF using BIO4
10785256|NCT03029611|BG000|Baseline|Treatment (Chemotherapy, IGFBP-2 Vaccine)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.~Carboplatin: Given IV~Gynecological Surgical Procedure: Undergo cytoreductive surgery~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID"
10785257|NCT03029611|FG000|Participant Flow|Treatment (Chemotherapy, IGFBP-2 Vaccine)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.~Carboplatin: Given IV~Gynecological Surgical Procedure: Undergo cytoreductive surgery~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID"
10785258|NCT03029611|OG000|Outcome|Treatment (Chemotherapy, IGFBP-2 Vaccine)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.~Carboplatin: Given IV~Gynecological Surgical Procedure: Undergo cytoreductive surgery~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID"
10785259|NCT03029611|EG000|Reported Event|Treatment (Chemotherapy, IGFBP-2 Vaccine)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.~Carboplatin: Given IV~Gynecological Surgical Procedure: Undergo cytoreductive surgery~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID"
10785260|NCT02891798|BG000|Baseline|Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)|"Patients will receive a nerve blocks consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)~Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements."
10785261|NCT02891798|BG001|Baseline|Bupivacaine Only (Control Arm)|"Patients will receive a nerve block consisting of bupivacaine only.~Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements."
11194438|NCT02152345|FG000|Participant Flow|Belatacept Immunosuppression|"Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84.~Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.~Standard of Care:~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered Day 0-3."
10785262|NCT02891798|BG002|Baseline|Total|Total of all reporting groups
10785263|NCT02891798|FG000|Participant Flow|Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)|"Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)~Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements"
10785264|NCT02891798|FG001|Participant Flow|Bupivacaine Only (Control Arm)|"Patients will receive a nerve block consisting of bupivacaine only.~Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements"
10785265|NCT02891798|OG000|Outcome|Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)|"Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)~Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements"
10785266|NCT02891798|OG001|Outcome|Bupivacaine Only (Control Arm)|"Patients will receive a nerve block consisting of bupivacaine only.~Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements"
10785267|NCT02891798|EG000|Reported Event|Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)|"Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)~Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements"
10785268|NCT02891798|EG001|Reported Event|Bupivacaine Only (Control Arm)|"Patients will receive a nerve block consisting of bupivacaine only.~Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements"
10785269|NCT02679781|BG000|Baseline|Oral Sedation|"administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785270|NCT02679781|BG001|Baseline|Nasal Sedation|"administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785271|NCT02679781|BG002|Baseline|Total|Total of all reporting groups
10785272|NCT02679781|FG000|Participant Flow|Oral Sedation|administration of 0.5mg/kg oral midazolam.
10785273|NCT02679781|FG001|Participant Flow|Nasal Sedation|administration of 0.2mg/kg nasal midazolam.
10785274|NCT02679781|OG000|Outcome|Oral Sedation|"administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785275|NCT02679781|OG001|Outcome|Nasal Sedation|"administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785276|NCT02679781|EG000|Reported Event|Oral Sedation|"administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785277|NCT02679781|EG001|Reported Event|Nasal Sedation|"administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.~nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood."
10785278|NCT02624869|BG000|Baseline|HeFH (Placebo in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.
10785279|NCT02624869|BG001|Baseline|HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785280|NCT02624869|BG002|Baseline|HoFH: Evolocumab 420 mg QM|Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785281|NCT02624869|BG003|Baseline|Total|Total of all reporting groups
10785282|NCT02624869|FG000|Participant Flow|HeFH (Placebo in Parent Study): Evolocumab 420 mg QM|Participants with heterozygous familial hypercholesterolemia (HeFH) who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.
10785283|NCT02624869|FG001|Participant Flow|HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785284|NCT02624869|FG002|Participant Flow|HoFH: Evolocumab 420 mg QM|Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785285|NCT02624869|OG000|Outcome|HeFH (Placebo in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.
10785286|NCT02624869|OG001|Outcome|HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785287|NCT02624869|OG002|Outcome|HoFH: Evolocumab 420 mg QM|Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785288|NCT02624869|OG000|Outcome|HoFH: Evolocumab 420 mg QM|Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
11194439|NCT02152345|FG001|Participant Flow|Standard Immunosuppression (Tacrolimus)|"Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL.~Standard of Care:~Tacrolimus 6 - 8 ng/mL administered daily thereafter until end of study.~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3."
11381717|NCT04590586|EG004|Reported Event|Zilucoplan + SoC|Participants received 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
10785289|NCT02624869|EG000|Reported Event|HeFH (Placebo in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.
10785290|NCT02624869|EG001|Reported Event|HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM|Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785291|NCT02624869|EG002|Reported Event|HoFH: Evolocumab 420 mg QM|Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
10785292|NCT02614690|BG000|Baseline|No Split Cast of Forearm Fractures|"Patient will have a No split cast long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.~No Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785293|NCT02614690|BG001|Baseline|Univalve Split Cast of Forearm Fractures|"Patients will have a Univalve Split Cast long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm~Univalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10803755|NCT02134028|FG004|Participant Flow|Participants From EFC13691: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with oral corticosteroids (OCS) and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11241018|NCT02484092|FG000|Participant Flow|SPK-9001 (5 x 10^11 vg/kg) IV Infusion|Participants were infused with 100 IU/kg of their usual FIX protein product over 10 minutes at Day 0 visit. Following the bolus infusion of the usual FIX protein product, the participant was infused with SPK-9001 (5 x 10^11 vg/kg) for approximately 60 minutes via infusion pump.
11381718|NCT04590586|EG005|Reported Event|Zilucoplan Placebo + SoC|Participants received placebo to zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment, in addition to standard of care.
11381719|NCT04312009|BG000|Baseline|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11381720|NCT04312009|BG001|Baseline|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 50 mg daily; oral administration"
11381721|NCT04312009|BG002|Baseline|Total|Total of all reporting groups
11381722|NCT04312009|FG000|Participant Flow|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11381723|NCT04312009|FG001|Participant Flow|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 50 mg daily; oral administration"
11381724|NCT04312009|OG000|Outcome|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11381725|NCT04312009|OG001|Outcome|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 50 mg daily; oral administration"
11381726|NCT04312009|EG000|Reported Event|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11381727|NCT04312009|EG001|Reported Event|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 50 mg daily; oral administration"
11381728|NCT04191382|BG000|Baseline|Amcenestrant 400 mg|Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
11381729|NCT04191382|BG001|Baseline|Amcenestrant 200 mg|Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
11381730|NCT04191382|BG002|Baseline|Letrozole 2.5 mg|Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
11381731|NCT04191382|BG003|Baseline|Total Title|
11381732|NCT04191382|FG000|Participant Flow|Amcenestrant 400 mg|Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
11381733|NCT04191382|FG001|Participant Flow|Amcenestrant 200 mg|Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
11381734|NCT04191382|FG002|Participant Flow|Letrozole 2.5 mg|Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
11381735|NCT04191382|OG000|Outcome|Amcenestrant 400 mg|Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
11381736|NCT04191382|OG001|Outcome|Amcenestrant 200 mg|Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
11381737|NCT04191382|OG002|Outcome|Letrozole 2.5 mg|Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
11381738|NCT04191382|EG000|Reported Event|Amcenestrant 400 mg|Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
11381739|NCT04191382|EG001|Reported Event|Amcenestrant 200 mg|Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
11381740|NCT04191382|EG002|Reported Event|Letrozole 2.5 mg|Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
11381741|NCT03964337|BG000|Baseline|Cabozantinib Followed by Prostatectomy (Arm A)|"Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.~Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381742|NCT03964337|BG001|Baseline|Immediate Prostatectomy (Arm B)|"Control group will receive an immediate prostatectomy.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381743|NCT03964337|BG002|Baseline|Total|Total of all reporting groups
11381744|NCT03964337|FG000|Participant Flow|Cabozantinib Followed by Prostatectomy (Arm A)|"Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.~Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381745|NCT03964337|FG001|Participant Flow|Immediate Prostatectomy (Arm B)|"Control group will receive an immediate prostatectomy.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381746|NCT03964337|OG000|Outcome|Cabozantinib Followed by Prostatectomy (Arm A)|"Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.~Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381747|NCT03964337|OG001|Outcome|Immediate Prostatectomy (Arm B)|"Control group will receive an immediate prostatectomy.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381748|NCT03964337|EG000|Reported Event|Cabozantinib Followed by Prostatectomy (Arm A)|"Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.~Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
11381749|NCT03964337|EG001|Reported Event|Immediate Prostatectomy (Arm B)|"Control group will receive an immediate prostatectomy.~Radical Prostatectomy: Radical prostatectomy as part of routine medical care."
10785294|NCT02614690|BG002|Baseline|Bivalve Split Cast of Forearm Fractures|"Patients will have a Bivalve Split Cast long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.~Bivalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785295|NCT02614690|BG003|Baseline|Total|Total of all reporting groups
10785296|NCT02614690|FG000|Participant Flow|No Split Cast of Forearm Fractures|"Patient will have a No split cast long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.~No Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785297|NCT02614690|FG001|Participant Flow|Univalve Split Cast of Forearm Fractures|"Patients will have a Univalve Split Cast long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm~Univalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785298|NCT02614690|FG002|Participant Flow|Bivalve Split Cast of Forearm Fractures|"Patients will have a Bivalve Split Cast long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.~Bivalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785299|NCT02614690|OG000|Outcome|No Split Cast of Forearm Fractures|"Patient will have a No split cast long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.~No Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785300|NCT02614690|OG001|Outcome|Univalve Split Cast of Forearm Fractures|"Patients will have a Univalve Split Cast long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm~Univalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785301|NCT02614690|OG002|Outcome|Bivalve Split Cast of Forearm Fractures|"Patients will have a Bivalve Split Cast long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.~Bivalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785302|NCT02614690|EG000|Reported Event|No Split Cast of Forearm Fractures|"Patient will have a No split cast long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.~No Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10964651|NCT00878644|BG000|Baseline|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
11241019|NCT02484092|OG000|Outcome|SPK-9001 (5 x 10^11 vg/kg)|Participants were infused with 100 IU/kg of their usual FIX protein product over 10 minutes at Day 0 visit. Following the bolus infusion of the usual FIX protein product, the participant was infused with SPK-9001 (5 x 10^11 vg/kg) for approximately 60 minutes via infusion pump.
11381750|NCT03937466|BG000|Baseline|Experimental Cooling Mattress Pad|"Subjects will use a cooling mattress pad nightly for approximately 8 weeks~Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed."
11381751|NCT03937466|FG000|Participant Flow|Experimental Cooling Mattress Pad|"Subjects will use a cooling mattress pad nightly for approximately 8 weeks~Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed."
11381752|NCT03937466|OG000|Outcome|Experimental Cooling Mattress Pad|"Subjects will use a cooling mattress pad nightly for approximately 8 weeks~Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed."
11381753|NCT03937466|EG000|Reported Event|Experimental Cooling Mattress Pad|"Subjects will use a cooling mattress pad nightly for approximately 8 weeks~Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed."
11381754|NCT03850483|BG000|Baseline|Vehicle Once Daily (QD)|During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381755|NCT03850483|BG001|Baseline|PF-06700841 0.1% QD|During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381756|NCT03850483|BG002|Baseline|PF-06700841 0.3% QD|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
10785303|NCT02614690|EG001|Reported Event|Univalve Split Cast of Forearm Fractures|"Patients will have a Univalve Split Cast long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm~Univalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
11381757|NCT03850483|BG003|Baseline|PF-06700841 1.0% QD|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381758|NCT03850483|BG004|Baseline|PF-06700841 3.0% QD|During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381759|NCT03850483|BG005|Baseline|Pooled Vehicle BID|During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381760|NCT03850483|BG006|Baseline|PF-06700841 0.3% BID|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381761|NCT03850483|BG007|Baseline|PF-06700841 1.0% BID|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381762|NCT03850483|BG008|Baseline|PF-06700841 3.0% BID|During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381763|NCT03850483|BG009|Baseline|Total|Total of all reporting groups
11381764|NCT03850483|FG000|Participant Flow|Stage 1: Vehicle Once Daily (QD)|During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381765|NCT03850483|FG001|Participant Flow|Stage 1: PF-06700841 0.1% QD|During stage 1 of the study participants topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381766|NCT03850483|FG002|Participant Flow|Stage 1: PF-06700841 0.3% QD|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381767|NCT03850483|FG003|Participant Flow|Stage 1: PF-06700841 1.0% QD|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381768|NCT03850483|FG004|Participant Flow|Stage 1: PF-06700841 3.0% QD|During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381769|NCT03850483|FG005|Participant Flow|Stage 1: Vehicle Twice Daily (BID)|During stage 1 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381770|NCT03850483|FG006|Participant Flow|Stage 1: PF-06700841 0.3% BID|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381771|NCT03850483|FG007|Participant Flow|Stage 1: PF-06700841 1.0% BID|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381772|NCT03850483|FG008|Participant Flow|Stage 2: Vehicle BID|During stage 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381773|NCT03850483|FG009|Participant Flow|Stage 2: PF-06700841 3.0% BID|During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11194440|NCT02152345|OG000|Outcome|Belatacept Immunosuppression|"Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84.~Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.~Standard of Care:~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered Day 0-3."
11241020|NCT02484092|EG000|Reported Event|SPK-9001 (5 x 10^11 vg/kg) IV Infusion|Participants were infused with 100 IU/kg of their usual FIX protein product over 10 minutes at Day 0 visit. Following the bolus infusion of the usual FIX protein product, the participant was infused with SPK-9001 (5 x 10^11 vg/kg) for approximately 60 minutes via infusion pump.
11381774|NCT03850483|OG000|Outcome|Vehicle Once Daily (QD)|During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381775|NCT03850483|OG001|Outcome|PF-06700841 0.1% QD|During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381776|NCT03850483|OG002|Outcome|PF-06700841 0.3% QD|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381777|NCT03850483|OG003|Outcome|PF-06700841 1.0% QD|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381778|NCT03850483|OG004|Outcome|PF-06700841 3.0% QD|During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381779|NCT03850483|OG005|Outcome|Pooled Vehicle BID|During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381780|NCT03850483|OG006|Outcome|PF-06700841 0.3% BID|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381781|NCT03850483|OG007|Outcome|PF-06700841 1.0% BID|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381782|NCT03850483|OG008|Outcome|PF-06700841 3.0% BID|During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11241021|NCT02484222|BG000|Baseline|The Result of Fentanyl Test|The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
11381783|NCT03850483|EG000|Reported Event|Vehicle Once Daily (QD)|During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381784|NCT03850483|EG001|Reported Event|PF-06700841 0.1% QD|During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381785|NCT03850483|EG002|Reported Event|PF-06700841 0.3% QD|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381786|NCT03850483|EG003|Reported Event|PF-06700841 1.0% QD|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381787|NCT03850483|EG004|Reported Event|PF-06700841 3.0% QD|During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381788|NCT03850483|EG005|Reported Event|Pooled Vehicle BID|During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381789|NCT03850483|EG006|Reported Event|PF-06700841 0.3% BID|During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381790|NCT03850483|EG007|Reported Event|PF-06700841 1.0% BID|During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381791|NCT03850483|EG008|Reported Event|PF-06700841 3.0% BID|During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
11381792|NCT03804879|BG000|Baseline|LMB763|50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
11381793|NCT03804879|BG001|Baseline|Placebo|Placebo was orally administered once daily for 24 weeks in addition to SoC.
11381794|NCT03804879|BG002|Baseline|Total|Total of all reporting groups
11381795|NCT03804879|FG000|Participant Flow|LMB763|50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
11381796|NCT03804879|FG001|Participant Flow|Placebo|Placebo was orally administered once daily for 24 weeks in addition to SoC.
11381797|NCT03804879|OG000|Outcome|LMB763|50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
11241022|NCT02484222|FG000|Participant Flow|The Result of Fentanyl Test|The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
11381798|NCT03804879|OG001|Outcome|Placebo|Placebo was orally administered once daily for 24 weeks in addition to SoC.
11381799|NCT03804879|EG000|Reported Event|LMB763|50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
10785304|NCT02614690|EG002|Reported Event|Bivalve Split Cast of Forearm Fractures|"Patients will have a Bivalve Split Cast long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.~Bivalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
10785305|NCT02569242|BG000|Baseline|Nivolumab Arm|Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
10785306|NCT02569242|BG001|Baseline|Active Comparator Arm （Docetaxel/Paclitaxel）|"Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~OR~Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
10785307|NCT02569242|BG002|Baseline|Total|Total of all reporting groups
10785308|NCT02569242|FG000|Participant Flow|Nivolumab Arm|Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
10785309|NCT02569242|FG001|Participant Flow|Active Comparator Arm （Docetaxel/Paclitaxel）|"Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~OR~Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
10785310|NCT02569242|OG000|Outcome|Nivolumab Arm|Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
10785311|NCT02569242|OG001|Outcome|Active Comparator Arm （Docetaxel/Paclitaxel）|"Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~OR~Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
10785312|NCT02569242|EG000|Reported Event|Nivolumab Arm|Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
10785313|NCT02569242|EG001|Reported Event|Active Comparator Arm （Docetaxel/Paclitaxel）|"Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~OR~Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
10785314|NCT02516969|BG000|Baseline|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy at the following levels: Treatment Volumes <25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
10785315|NCT02516969|BG001|Baseline|Observation Cohort|No Stereotactic Body Radiotherapy
10785316|NCT02516969|BG002|Baseline|Total|Total of all reporting groups
10785317|NCT02516969|FG000|Participant Flow|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy at the following levels: Treatment Volumes <25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
10785318|NCT02516969|FG001|Participant Flow|Observation|No Stereotactic Body Radiotherapy
10785319|NCT02516969|OG000|Outcome|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy at the following levels: Treatment Volumes <25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
10785320|NCT02516969|OG001|Outcome|Observation Cohort|No Stereotactic Body Radiotherapy treatment
10785321|NCT02516969|OG001|Outcome|Observation Cohort|No Stereotactic Body Radiotherapy
10785322|NCT02516969|OG001|Outcome|Observation|No Stereotactic Body Radiotherapy treatment
10785323|NCT02516969|EG000|Reported Event|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy at the following levels: Treatment Volumes <25cc will receive 40Gy (5 fractions of 8Gy per fraction) or treatment Volumes ≥25cc will receive 44-50Gy (5 fractions of 8.8-10Gy per fraction). Ideally all tumors volumes ≥25cc will receive 50Gy over 5 fractions, however at the discretion of the treating radiation oncologist based on tumor bed volume, prior radiation dose, and proximity to critical organs the dose can be reduced to 44Gy over 5 fractions as outlined in prior SBRT protocols.
10785324|NCT02516969|EG001|Reported Event|Observation Cohort|No Stereotactic Body Radiotherapy treatment
11241023|NCT02484222|OG000|Outcome|The Result of Fentanyl Test|The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
11241024|NCT02484222|OG000|Outcome|Nausea and Vomiting|post-operative nausea and vomiting
11241025|NCT02484222|OG000|Outcome|Number of Participants With Pulse Oxygen Saturation Less Than|Number of Participants with Pulse Oxygen Saturation Less Than 95 Percent
10785325|NCT02507960|BG000|Baseline|Pilot Study|"The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.~The Gamma Pod: Immobilization of breast during radiation.~CT simulation: See arm description"
10785326|NCT02507960|FG000|Participant Flow|Pilot Study|"The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.~The Gamma Pod: Immobilization of breast during radiation.~CT simulation: See arm description"
10785327|NCT02507960|OG000|Outcome|Pilot Study|"The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.~The Gamma Pod: Immobilization of breast during radiation.~CT simulation: See arm description"
10785328|NCT02507960|EG000|Reported Event|Pilot Study|"The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.~The Gamma Pod: Immobilization of breast during radiation.~CT simulation: See arm description"
10785329|NCT02435433|BG000|Baseline|Ramucirumab + BSC|8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785330|NCT02435433|BG001|Baseline|Placebo + Best Supportive Care (BSC)|"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.~Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm."
10785331|NCT02435433|BG002|Baseline|Total|Total of all reporting groups
10785332|NCT02435433|FG000|Participant Flow|Ramucirumab|8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785333|NCT02435433|FG001|Participant Flow|Placebo|"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.~Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm."
10785334|NCT02435433|FG002|Participant Flow|Open Label Ramucirumab|8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785335|NCT02435433|FG003|Participant Flow|Ramucirumab ME2 Cohort|8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785336|NCT02435433|FG004|Participant Flow|Placebo ME2 Cohort|"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.~Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm."
10785337|NCT02435433|OG000|Outcome|Ramucirumab + Best Supportive Care (BSC)|8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785338|NCT02435433|OG001|Outcome|Placebo + BSC|"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.~Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm."
10785339|NCT02435433|OG000|Outcome|Ramucirumab + BSC|8 mg/kg ramucirumab administered as an intravenous IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785340|NCT02435433|OG000|Outcome|Ramucirumab + BSC|8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785341|NCT02435433|EG000|Reported Event|Ramucirumab|8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
10785342|NCT02435433|EG001|Reported Event|Placebo|"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.~Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm."
10785343|NCT02426125|BG000|Baseline|Ramucirumab + Docetaxel|Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785344|NCT02426125|BG001|Baseline|Placebo + Docetaxel|Placebo IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
11381800|NCT03804879|EG001|Reported Event|Placebo|Placebo was orally administered once daily for 24 weeks in addition to SoC.
10785345|NCT02426125|BG002|Baseline|Total|Total of all reporting groups
11241026|NCT02484222|EG000|Reported Event|The Result of Fentanyl Test|The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
11381801|NCT03804879|EG002|Reported Event|Total|Total
10785346|NCT02426125|FG000|Participant Flow|Ramucirumab + Docetaxel|Ramucirumab (10 milligram/kilogram [mg/kg]) intravenously (IV) plus docetaxel (75 milligram/square meter [mg/m²]) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785347|NCT02426125|FG001|Participant Flow|Placebo + Docetaxel|Placebo IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785348|NCT02426125|OG000|Outcome|Ramucirumab + Docetaxel|Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785349|NCT02426125|OG001|Outcome|Placebo + Docetaxel|Placebo IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785350|NCT02426125|OG000|Outcome|Ramucirumab + Docetaxel|Ramucirumab (10 mg/kg) IV plus docetaxel IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785351|NCT02426125|OG000|Outcome|Ramucirumab + Docetaxel|Ramucirumab IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785352|NCT02426125|EG000|Reported Event|Ramucirumab + Docetaxel|Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785353|NCT02426125|EG001|Reported Event|Placebo + Docetaxel|Placebo IV plus docetaxel (75 mg/m²) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
10785354|NCT02417142|BG000|Baseline|Experimental|"(existing treatment) + (Drug)~Intervention:~Drug: Exenatide~Exenatide: Exenatide IM 2mg/week for 24 weeks."
10785355|NCT02417142|BG001|Baseline|Placebo|"(existing treatment) + (Placebo)~Intervention:~Drug: Placebo~Placebo: Placebo IM for 24 weeks."
10785356|NCT02417142|BG002|Baseline|Total|Total of all reporting groups
10785357|NCT02417142|FG000|Participant Flow|Experimental|"(existing treatment) + (Drug)~Intervention:~Drug: Exenatide~Exenatide: Exenatide 2mg/week subcutaneous injection for 24 weeks."
10785358|NCT02417142|FG001|Participant Flow|Placebo|"(existing treatment) + (Placebo)~Intervention:~Drug: Placebo~Placebo: Placebo IM for 24 weeks."
10785359|NCT02417142|OG000|Outcome|Experimental|"(existing treatment) + (Drug)~Intervention:~Drug: Exenatide~Exenatide: Exenatide IM 2mg/week for 24 weeks."
10785360|NCT02417142|OG001|Outcome|Placebo|"(existing treatment) + (Placebo)~Intervention:~Drug: Placebo~Placebo: Placebo IM for 24 weeks."
10785361|NCT02417142|EG000|Reported Event|Experimental|"(existing treatment) + (Drug)~Intervention:~Drug: Exenatide~Exenatide: Exenatide IM 2mg/week for 24 weeks."
10785362|NCT02417142|EG001|Reported Event|Placebo|"(existing treatment) + (Placebo)~Intervention:~Drug: Placebo~Placebo: Placebo IM for 24 weeks."
10785363|NCT02368886|BG000|Baseline|Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785364|NCT02368886|BG001|Baseline|Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10785365|NCT02368886|BG002|Baseline|Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785366|NCT02368886|BG003|Baseline|Arm B2 (Regorafenib Standard Dose + Reactive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10785367|NCT02368886|BG004|Baseline|Total|Total of all reporting groups
10785368|NCT02368886|FG000|Participant Flow|Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785369|NCT02368886|FG001|Participant Flow|Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10803756|NCT02134028|FG005|Participant Flow|Participants From EFC13691: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10785370|NCT02368886|FG002|Participant Flow|Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785371|NCT02368886|FG003|Participant Flow|Arm B2 (Regorafenib Standard Dose + Reactive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10785372|NCT02368886|OG000|Outcome|Regorafenib Dose Escalation Group|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
10785373|NCT02368886|OG001|Outcome|Regorafenib Standard Dose Group|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
10785374|NCT02368886|EG000|Reported Event|Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785375|NCT02368886|EG001|Reported Event|Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)|In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10785376|NCT02368886|EG002|Reported Event|Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
10785377|NCT02368886|EG003|Reported Event|Arm B2 (Regorafenib Standard Dose + Reactive Strategy)|In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
10785378|NCT02354703|BG000|Baseline|Ondansetron--non-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785379|NCT02354703|BG001|Baseline|Ondansetron-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785380|NCT02354703|BG002|Baseline|Placebo--responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Placebo: Placebo + BBCET counseling"
10785381|NCT02354703|BG003|Baseline|Placebo--non-responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Placebo: Placebo + BBCET counseling"
10785382|NCT02354703|BG004|Baseline|Total|Total of all reporting groups
11241027|NCT02484547|BG000|Baseline|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241028|NCT02484547|BG001|Baseline|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241029|NCT02484547|BG002|Baseline|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10785383|NCT02354703|FG000|Participant Flow|Ondansetron--non-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
11381802|NCT03804684|BG000|Baseline|Healthy Controls|"Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.~Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.~visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting."
11381803|NCT03804684|BG001|Baseline|Glaucoma Group|"Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.~Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.~visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting."
11381804|NCT03804684|BG002|Baseline|Total|Total of all reporting groups
11381805|NCT03804684|FG000|Participant Flow|Healthy Controls|Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381806|NCT03804684|FG001|Participant Flow|Glaucoma Group|Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381807|NCT03804684|OG000|Outcome|Healthy Controls|Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381808|NCT03804684|OG001|Outcome|Glaucoma Group|Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381809|NCT03804684|OG000|Outcome|Healthy Controls|Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381810|NCT03804684|OG001|Outcome|Glaucoma Group|Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
11381811|NCT03804684|EG000|Reported Event|Healthy Controls|"Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.~Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.~visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting."
11241030|NCT02484547|BG003|Baseline|Total|Total of all reporting groups
11241031|NCT02484547|FG000|Participant Flow|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10964652|NCT00878644|BG001|Baseline|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
11194441|NCT02152345|OG001|Outcome|Standard Immunosuppression (Tacrolimus)|"Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL.~Standard of Care:~Tacrolimus 6 - 8 ng/mL administered daily thereafter until end of study.~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3."
11194442|NCT02152345|EG000|Reported Event|Belatacept Immunosuppression|"Renal transplant recipients will receive Methylprednisolone, rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Belatacept 10 mg/kg will be administered in the operating room ~1 hr prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: 5, 14, 30, 56, & 84.~Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.~Standard of Care:~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered Day 0-3."
11194443|NCT02152345|EG001|Reported Event|Standard Immunosuppression (Tacrolimus)|"Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.~Tacrolimus 0.05 mg/kg PO every 12 hrs will be on Day 0 after transplantation. It will then be administered on the following post-transplantation days: 3-90 at 8-12ng/mL; Day 91-180 at 8-10 ng/mL.~Standard of Care:~Tacrolimus 6 - 8 ng/mL administered daily thereafter until end of study.~Mycophenolate: 720 mg by mouth every 12 hours (Day 0)(1080 mg AA).~rATG: 1.5 mg/kg IV daily on Day 0-3.~Methylprednisolone: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3."
11194444|NCT02152371|BG000|Baseline|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
11194445|NCT02152371|BG001|Baseline|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
11194446|NCT02152371|BG002|Baseline|Total|Total of all reporting groups
11194447|NCT02152371|FG000|Participant Flow|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
11194448|NCT02152371|FG001|Participant Flow|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
11194449|NCT02152371|OG000|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
10964653|NCT00878644|BG002|Baseline|Total|Total of all reporting groups
11194450|NCT02152371|OG001|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
11194451|NCT02152371|EG000|Reported Event|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
11194452|NCT02152371|EG001|Reported Event|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
11194453|NCT02152384|BG000|Baseline|All Participants|All randomized participants who received at least 1 dose of study drug.
11194454|NCT02152384|FG000|Participant Flow|Treatment Sequence A/B|"Treatment A: Insulin peglispro (LY2605541) once daily subcutaneous (SC). Insulin lispro given SC prandially or as bolus as required~Treatment B: Insulin glargine once daily subcutaneous (SC). Insulin lispro given SC prandially or as bolus as required"
10803757|NCT02134028|FG006|Participant Flow|Participants From PDY14192: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11381812|NCT03804684|EG001|Reported Event|Glaucoma Group|"Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.~Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.~visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting."
11381813|NCT03631706|BG000|Baseline|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381814|NCT03631706|BG001|Baseline|Pembrolizumab|Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381815|NCT03631706|BG002|Baseline|Total|Total of all reporting groups
11381816|NCT03631706|FG000|Participant Flow|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381817|NCT03631706|FG001|Participant Flow|Pembrolizumab|Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381818|NCT03631706|OG000|Outcome|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381819|NCT03631706|OG001|Outcome|Pembrolizumab|Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381820|NCT03631706|EG000|Reported Event|M7824|Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381821|NCT03631706|EG001|Reported Event|Pembrolizumab|Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
11381822|NCT03537014|BG000|Baseline|MDMA-assisted Therapy|"Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively."
11381823|NCT03537014|BG001|Baseline|Placebo With Therapy|"Administration of inactive placebo in combination with psychotherapy~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy"
11194455|NCT02152384|FG001|Participant Flow|Treatment Sequence B/A|"Treatment B: Insulin glargine once daily subcutaneous (SC). Insulin lispro given SC prandially or as bolus as required~Treatment A: Insulin peglispro (LY2605541) once daily subcutaneous (SC). Insulin lispro given SC prandially or as bolus as required"
11381824|NCT03537014|BG002|Baseline|Total|Total of all reporting groups
11381825|NCT03537014|FG000|Participant Flow|MDMA-assisted Therapy|"Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively."
11381826|NCT03537014|FG001|Participant Flow|Placebo With Therapy|"Administration of inactive placebo in combination with psychotherapy~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy"
11381827|NCT03537014|OG000|Outcome|MDMA-assisted Therapy|"Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively."
11381828|NCT03537014|OG001|Outcome|Placebo With Therapy|"Administration of inactive placebo in combination with psychotherapy~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy"
11381829|NCT03537014|EG000|Reported Event|MDMA-assisted Therapy|"Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~MDMA: Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively."
11381830|NCT03537014|EG001|Reported Event|Placebo With Therapy|"Administration of inactive placebo in combination with psychotherapy~Psychotherapy: Standardized non-directive psychotherapy performed by therapist team~Placebo: Administration of placebo during three sessions of MDMA-assisted psychotherapy"
11381831|NCT03529799|BG000|Baseline|Injured Participants|"Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381832|NCT03529799|BG001|Baseline|Uninjured Participants|"Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381833|NCT03529799|BG002|Baseline|Total|Total of all reporting groups
10785384|NCT02354703|FG001|Participant Flow|Ondansetron-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785385|NCT02354703|FG002|Participant Flow|Placebo--responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Placebo: Placebo + BBCET counseling"
10785386|NCT02354703|FG003|Participant Flow|Placebo--non-responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Placebo: Placebo + BBCET counseling"
10785387|NCT02354703|OG000|Outcome|Ondansetron-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785388|NCT02354703|OG001|Outcome|Ondansetron--non-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785389|NCT02354703|OG002|Outcome|Placebo--responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Placebo: Placebo + BBCET counseling"
10785390|NCT02354703|OG003|Outcome|Placebo--non-responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Placebo: Placebo + BBCET counseling"
10785391|NCT02354703|OG000|Outcome|Ondansetron--non-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785392|NCT02354703|OG001|Outcome|Ondansetron-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785393|NCT02354703|EG000|Reported Event|Ondansetron--non-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785394|NCT02354703|EG001|Reported Event|Ondansetron-responsive Genotype|"ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling"
10785395|NCT02354703|EG002|Reported Event|Placebo--responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:~if European ancestry:~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~HTR3A gene:~rs1150226:AG; or rs1176713:GG~HTR3B gene:~rs17619942:AC~If African ancestry:~HTR3B gene:~rs176744: CC or CA~SLC6A4 gene:~5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT~Placebo: Placebo + BBCET counseling"
10785396|NCT02354703|EG003|Reported Event|Placebo--non-responsive Genotype|"placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes~Placebo: Placebo + BBCET counseling"
10785397|NCT01981551|BG000|Baseline|PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis|"PF-03084014 will be administered orally at 150 mg twice a day in 21-day cycles~PF-03084014: Treatment with the selective small-molecule >=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early-phase clinical trial."
10785398|NCT01981551|FG000|Participant Flow|PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis|"PF-03084014 will be administered orally at 150 mg twice a day in 21-day cycles~PF-03084014: Treatment with the selective small-molecule >=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early-phase clinical trial."
10785399|NCT01981551|OG000|Outcome|PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis|"PF-03084014 will be administered orally at 150 mg twice a day in 21-day cycles~PF-03084014: Treatment with the selective small-molecule >=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early-phase clinical trial."
10785400|NCT01981551|EG000|Reported Event|PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis|"PF-03084014 will be administered orally at 150 mg twice a day in 21-day cycles~PF-03084014: Treatment with the selective small-molecule >=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early-phase clinical trial."
10785401|NCT00740181|BG000|Baseline|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
10785402|NCT00740181|FG000|Participant Flow|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
10785403|NCT00740181|OG000|Outcome|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
10785404|NCT00740181|EG000|Reported Event|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
10785405|NCT00468130|BG000|Baseline|Aripiprazole|"Subjects in the experimental group will receive Aripiprazole~Aripiprazole: Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785406|NCT00468130|BG001|Baseline|Placebo|"Subjects in the control group will receive sugar pill~Placebos: Inactive tablet made to resemble active tablet~Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785407|NCT00468130|BG002|Baseline|Total|Total of all reporting groups
10785408|NCT00468130|FG000|Participant Flow|Aripiprazole|"Subjects in the experimental group will receive Aripiprazole~Aripiprazole: Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785409|NCT00468130|FG001|Participant Flow|Placebo|"Subjects in the control group will receive sugar pill~Placebos: Inactive tablet made to resemble active tablet~Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785410|NCT00468130|OG000|Outcome|Aripiprazole|"Subjects in the experimental group will receive Aripiprazole~Aripiprazole: Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
11194456|NCT02152384|OG000|Outcome|Insulin Peglispro (LY2605541)|Insulin peglispro (LY2605541) administered SC daily
11194457|NCT02152384|OG001|Outcome|Insulin Glargine|Insulin glargine administered SC daily
11194458|NCT02152384|OG000|Outcome|Insulin Peglispro (LY2605541, With Insulin Lispro)|Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
11194459|NCT02152384|OG001|Outcome|Insulin Glargine (With Insulin Lispro)|Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required
11194460|NCT02152384|OG000|Outcome|Insulin Peglispro (LY2605541, With Insulin Lispro)|Insulin peglispro (LY2605541, once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
10785411|NCT00468130|OG001|Outcome|Placebo|"Subjects in the control group will receive sugar pill~Placebos: Inactive tablet made to resemble active tablet~Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785412|NCT00468130|OG000|Outcome|Aripiprazole|Participants in the clinical trial who were given aripiprazole
10785413|NCT00468130|OG001|Outcome|Placebo|Participants in the clinical trial who were given placebo
10803758|NCT02134028|FG007|Participant Flow|Participants From PDY14192: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10850640|NCT00303719|OG001|Outcome|Standard Risk Patients|Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder
10785414|NCT00468130|EG000|Reported Event|Aripiprazole|"Subjects in the experimental group will receive Aripiprazole~Aripiprazole: Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785415|NCT00468130|EG001|Reported Event|Placebo|"Subjects in the control group will receive sugar pill~Placebos: Inactive tablet made to resemble active tablet~Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
10785416|NCT00384111|BG000|Baseline|All Enrolled Participants|Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
10785417|NCT00384111|FG000|Participant Flow|All Enrolled Participants|Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
10785418|NCT00384111|OG000|Outcome|All Enrolled Participants|Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
10785419|NCT00384111|EG000|Reported Event|All Enrolled Participants|Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
10802053|NCT03151304|EG000|Reported Event|Stage 1a and 1b Open-label Pracinostat Plus Azacitidine|"open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.~In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.~Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:~Schedule 1 - daily therapy on Days 1 through 7~Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle~Pracinostat: 45 mg capsule~Azacitidine: SC or IV injection"
10802054|NCT03113409|BG000|Baseline|Procedure 1|"Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
10802055|NCT03113409|FG000|Participant Flow|Procedure 1|"Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
10802056|NCT03113409|FG001|Participant Flow|Procedure 2|"Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
10802057|NCT03113409|FG002|Participant Flow|Procedure 3|"Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
10802058|NCT03113409|OG000|Outcome|Procedure 1|"Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
10802059|NCT03113409|EG000|Reported Event|Procedure 1|"Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.~Buprenorphine: Buprenorphine will be administered daily~Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX~Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later."
11194461|NCT02152384|OG000|Outcome|Insulin Peglispro (LY2605541), With Insulin Lispro)|Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
11194462|NCT02152384|EG000|Reported Event|Insulin Peglispro (LY2605541, With Insulin Lispro)|Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
10785420|NCT04854642|BG000|Baseline|Enrolled and Safety Set, PK Set 1 and PK Set 2|"Demographics are reported for the enrolled set (N=36), which has the same number of participants of the safety set, the PK set 1, and the PK set 2."
10785421|NCT04854642|FG000|Participant Flow|T - R (Fed Then Fasting Condition)|"Subjects were assigned to the sequence of treatments TR to receive Ladarixin in fed conditions (T treatment) during period 1 and in fasting conditions (R treatment) in period 2.~Ladarixin: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations."
10785422|NCT04854642|FG001|Participant Flow|R - T (Fasting Then Fed Condition)|"Subjects were assigned to the sequence of treatments RT to receive Ladarixin ini fasting conditions (R treatment) in period 1 and in fed conditions (T treatment) during period 2.~Ladarixin: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations."
10785423|NCT04854642|OG000|Outcome|Ladarixin Fed (T)|Ladarixin - Fed Condition: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) condition.
10785424|NCT04854642|OG001|Outcome|Ladarixin Fasting (R)|Ladarixin - Fasting condition: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fasting (Reference treatment) condition.
10785425|NCT04854642|OG001|Outcome|Ladarixin Fasting (R)|Ladarixin - Fasting condition: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fasting (Reference treatment) condition..
10785426|NCT04854642|OG000|Outcome|Enrolled and Safety Set, PK Set 1 and PK Set 2|"Demographics are reported for the enrolled set (N=36); which has the same number of participants of the safety set, the PK set 1 and the PK set 2"
10785427|NCT04854642|EG000|Reported Event|Ladarixin Fed (T)|Ladarixin - Fed Conditions: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) conditions.
10785428|NCT04854642|EG001|Reported Event|Ladarixin Fasting (R)|Ladarixin - Fasting conditions: A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fasting (Reference treatment) conditions.
10964654|NCT00878644|FG000|Participant Flow|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10964655|NCT00878644|FG001|Participant Flow|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
11194463|NCT02152384|EG001|Reported Event|Insulin Glargine (With Insulin Lispro)|Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required
11194464|NCT02152540|BG000|Baseline|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11194465|NCT02152540|BG001|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment"
11194466|NCT02152540|BG002|Baseline|Total|Total of all reporting groups
11194467|NCT02152540|FG000|Participant Flow|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
10964656|NCT00878644|OG000|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10964657|NCT00878644|OG001|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10964658|NCT00878644|EG000|Reported Event|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10964659|NCT00878644|EG001|Reported Event|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10964660|NCT00878709|BG000|Baseline|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964661|NCT00878709|BG001|Baseline|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964662|NCT00878709|BG002|Baseline|Total|Total of all reporting groups
10964663|NCT00878709|FG000|Participant Flow|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964664|NCT00878709|FG001|Participant Flow|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964665|NCT00878709|OG000|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964666|NCT00878709|OG001|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964667|NCT00878709|OG001|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
11194468|NCT02152540|FG001|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment"
11194469|NCT02152540|OG000|Outcome|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
11194470|NCT02152540|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment"
10964668|NCT00878709|EG000|Reported Event|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964669|NCT00878709|EG001|Reported Event|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
10964670|NCT00878722|BG000|Baseline|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
10785446|NCT04583592|BG000|Baseline|Camostat Mesilate|"Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.~Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days."
10785447|NCT04583592|BG001|Baseline|Placebo|"Participants will receive placebo for 14 days in addition to standard of care treatment.~Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days."
10785448|NCT04583592|BG002|Baseline|Total|Total of all reporting groups
10785449|NCT04583592|FG000|Participant Flow|Camostat Mesilate|"Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.~Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days."
10785450|NCT04583592|FG001|Participant Flow|Placebo|"Participants will receive placebo for 14 days in addition to standard of care treatment.~Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days."
10785451|NCT04583592|OG000|Outcome|Camostat Mesilate|"Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.~Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days."
10785452|NCT04583592|OG001|Outcome|Placebo|"Participants will receive placebo for 14 days in addition to standard of care treatment.~Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days."
10964671|NCT00878722|BG001|Baseline|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
10964672|NCT00878722|BG002|Baseline|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
10964673|NCT00878722|BG003|Baseline|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
10964674|NCT00878722|BG004|Baseline|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
11194471|NCT02152540|OG000|Outcome|ACTIVE rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation~n = 12"
11194472|NCT02152540|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment~n = 13"
11194473|NCT02152540|OG000|Outcome|ACTIVE rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS.~rTMS: Repetitive Transcranial Magnetic Stimulation~Here we report the results where we adjusted for PTSD to predict Trails B performance"
11194474|NCT02152540|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment~Here we report the results where we adjusted for PTSD to predict Trails B performance."
10785453|NCT04583592|EG000|Reported Event|Camostat Mesilate|"Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.~Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days."
10785454|NCT04583592|EG001|Reported Event|Placebo|"Participants will receive placebo for 14 days in addition to standard of care treatment.~Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days."
10785455|NCT04572399|BG000|Baseline|Endotracheal UV Light|"Mechanically ventilated patients who will receive UV Light therapy~UV Light Treatment: UV light therapy administered while patient is mechanically ventilated"
10785456|NCT04572399|FG000|Participant Flow|Endotracheal UV Light|"Mechanically ventilated patients who will receive UV Light therapy~UV Light Treatment: UV light therapy administered while patient is mechanically ventilated"
10785457|NCT04572399|OG000|Outcome|Endotracheal UV Light|"Mechanically ventilated patients who will receive UV Light therapy~UV Light Treatment: UV light therapy administered while patient is mechanically ventilated"
10785458|NCT04572399|EG000|Reported Event|Endotracheal UV Light|"Mechanically ventilated patients who will receive UV Light therapy~UV Light Treatment: UV light therapy administered while patient is mechanically ventilated~No treatment-emergent adverse events or need for treatment cessation was observed in the study. Oxygen saturations and hemodynamics during all treatment sessions remained stable. None of the subjects experienced pneumothorax, subcutaneous emphysema, venous thromboembolism, or endotracheal tube (ETT) dislodgment."
10802060|NCT03007979|BG000|Baseline|Palbociclib + Letrozole or + Fulvestrant|"Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).~Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.~Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.~Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.~Optional research biopsy at baseline and progression~Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression"
10802061|NCT03007979|FG000|Participant Flow|Palbociclib + Letrozole or + Fulvestrant|"Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).~Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.~Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.~Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.~Optional research biopsy at baseline and progression~Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression"
11194475|NCT02152540|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment~n = 12"
10802062|NCT03007979|OG000|Outcome|Palbociclib + Letrozole or + Fulvestrant|"Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).~Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.~Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.~Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.~Optional research biopsy at baseline and progression~Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression"
10802063|NCT03007979|EG000|Reported Event|Palbociclib + Letrozole or + Fulvestrant|"Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).~Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.~Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.~Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.~Optional research biopsy at baseline and progression~Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression"
10802064|NCT02953340|BG000|Baseline|(Arm 1): SPI-2012 and TC|At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, [3.6 mg granulocyte colony-stimulating factor {G-CSF}] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10802065|NCT02953340|BG001|Baseline|(Arm 2): Pegfilgrastim and TC|At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10802066|NCT02953340|BG002|Baseline|Total|Total of all reporting groups
11194476|NCT02152540|OG000|Outcome|ACTIVE rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation~n = 17"
10785459|NCT04388787|BG000|Baseline|Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration|"There was only one arm to the study. Participants were not assigned to different arms based on order of treatment because treatment order was not relevant to the outcome and was not tracked in the data set. Each participant completed all treatments in one session. Order of blinded and sham treatments was randomized at the time data was collected. The unblinded treatment was always last.~Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments under 3 treatments, the first two in random order and the third always last:~Blinded: SR applied sub threshold at 90% of participant's detection threshold~Blinded Sham: SR devices worn but not turned on (0% of participant's detection threshold).~Unblinded: SR is applied above participant's detection threshold at a participant selected intensity."
10785460|NCT04388787|FG000|Participant Flow|Subthreshold, Sham, and Above Threshold Stochastic Resonance (SR) Vibration|"There was only one arm to the study. Participants were not assigned to different arms based on order of treatment because treatment order was not relevant to the outcome and was not tracked in the data set. Each participant completed all treatments in one session. Order of blinded and sham treatments was randomized at the time data was collected. The unblinded treatment was always last.~Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments under 3 treatments, the first two in random order and the third always last:~Blinded: SR applied sub threshold at 90% of participant's detection threshold~Blinded Sham: SR devices worn but not turned on (0% of participant's detection threshold).~Unblinded: SR is applied above participant's detection threshold at a participant selected intensity."
10785461|NCT04388787|OG000|Outcome|Blinded Subthreshold Stochastic Resonance (SR) Vibration|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments with SR vibration applied sub threshold at 90% of participant's detection threshold."
10785462|NCT04388787|OG001|Outcome|Blinded Sham Treatment|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments with SR devices worn but not turned on (0% of participant's detection threshold)."
10785463|NCT04388787|OG002|Outcome|Unblinded Above Threshold SR Vibration|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments SR is applied above participant's detection threshold at a participant selected intensity."
10785464|NCT04388787|EG000|Reported Event|Blinded Subthreshold Stochastic Resonance (SR) Vibration|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments with SR vibration applied sub threshold at 90% of participant's detection threshold."
10785465|NCT04388787|EG001|Reported Event|Blinded Sham Treatment|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments with SR devices worn but not turned on (0% of participant's detection threshold)."
10802067|NCT02953340|FG000|Participant Flow|(Arm 1): SPI-2012 and TC|At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF}] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10785466|NCT04388787|EG002|Reported Event|Unblinded Above Threshold SR Vibration|"Stochastic resonance (SR) wraps: SR wraps were applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators were secured around the shoulder. The threshold for detection of SR was determined by the examiner prior to initiating the test condition. The intensity of the stimulation was adjustable with a scroll bar on the app and ranged from a 0 - 100. The examiner gradually increased the stimulus intensity until the participant reported being able to feel it. This set the participant's detection threshold.~Once the detection threshold was established, participant completed the assessments SR is applied above participant's detection threshold at a participant selected intensity."
10785467|NCT04380090|BG000|Baseline|Drug: Docusate Sodium|"Docusate sodium one pill to was taken twice a day by mouth for 28 days~Docusate Sodium: Patients in the docusate sodium arm received the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days."
10785468|NCT04380090|BG001|Baseline|Drug: Propylene Glycol|"One standard dose (17 grams) of propylene glycol by mouth on postoperative day one~Propylene Glycol: Patients in the propylene glycol arm received one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery."
10785469|NCT04380090|BG002|Baseline|Total|Total of all reporting groups
10785470|NCT04380090|FG000|Participant Flow|Drug: Docusate Sodium|"Docusate sodium one pill to be taken twice a day by mouth for 28 days~Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days"
10785471|NCT04380090|FG001|Participant Flow|Drug: Propylene Glycol|"One standard dose (17 grams) of propylene glycol by mouth on postoperative day one~Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery"
10785472|NCT04380090|OG000|Outcome|Drug: Docusate Sodium|"Docusate sodium one pill to be taken twice a day by mouth for 28 days~Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days"
10785473|NCT04380090|OG001|Outcome|Drug: Propylene Glycol|"One standard dose (17 grams) of propylene glycol by mouth on postoperative day one~Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery"
10785474|NCT04380090|OG000|Outcome|Drug: Docusate Sodium|Docusate sodium one pill to be taken twice a day by mouth for 28 days Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
10785475|NCT04380090|OG001|Outcome|Drug: Propylene Glycol|One standard dose (17 grams) of propylene glycol by mouth on postoperative day one Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
10785476|NCT04380090|OG000|Outcome|Drug: Docusate Sodium|"Docusate sodium one pill to was taken twice a day by mouth for 28 days~Docusate Sodium: Patients in the docusate sodium arm received the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days."
10785477|NCT04380090|OG001|Outcome|Drug: Propylene Glycol|"One standard dose (17 grams) of propylene glycol by mouth on postoperative day one~Propylene Glycol: Patients in the propylene glycol arm received one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery."
10785478|NCT04380090|EG000|Reported Event|Drug: Docusate Sodium|"Docusate sodium one pill to was taken twice a day by mouth for 28 days~Docusate Sodium: Patients in the docusate sodium arm received the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days."
10785479|NCT04380090|EG001|Reported Event|Drug: Propylene Glycol|"One standard dose (17 grams) of propylene glycol by mouth on postoperative day one~Propylene Glycol: Patients in the propylene glycol arm received one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery."
10785480|NCT04377620|BG000|Baseline|Ruxolitininb 15mg + Standard of Care (SoC)|Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785481|NCT04377620|BG001|Baseline|Ruxolitinib 5mg + Standard of Care (SoC)|Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785482|NCT04377620|BG002|Baseline|Placebo + Standard of Care (SoC)|Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785483|NCT04377620|BG003|Baseline|Total|Total of all reporting groups
10785484|NCT04377620|FG000|Participant Flow|Ruxolitininb 15mg + Standard of Care|Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785485|NCT04377620|FG001|Participant Flow|Ruxolitinib 5mg + Standard of Care (SoC)|Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785486|NCT04377620|FG002|Participant Flow|Placebo + Standard of Care (SoC)|Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785487|NCT04377620|OG000|Outcome|Ruxolitininb 15mg + Standard of Care (SoC)|Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
10785488|NCT04377620|OG001|Outcome|Ruxolitinib 5mg + Standard of Care (SoC)|Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
11381834|NCT03529799|FG000|Participant Flow|Injured Participants|"Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381835|NCT03529799|FG001|Participant Flow|Uninjured Participants|"Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381836|NCT03529799|OG000|Outcome|Injured Participants|"Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381837|NCT03529799|OG001|Outcome|Uninjured Participants|"Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381838|NCT03529799|EG000|Reported Event|Injured Participants|"Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381839|NCT03529799|EG001|Reported Event|Uninjured Participants|"Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles~I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology"
11381840|NCT03485287|BG000|Baseline|MDMA-assisted Therapy (100 to 125 mg of MDMA)|Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
11381841|NCT03485287|FG000|Participant Flow|MDMA-assisted Therapy (100 to 125 mg of MDMA)|Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
11381842|NCT03485287|OG000|Outcome|MDMA-assisted Therapy (100 to 125 mg of MDMA)|Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
11381843|NCT03485287|EG000|Reported Event|MDMA-assisted Therapy (100 to 125 mg of MDMA)|Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
10785489|NCT04377620|OG002|Outcome|Placebo + Standard of Care (SoC)|Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
11381844|NCT03473925|BG000|Baseline|Navarixin 30 mg + Pembrolizumab 200 mg|Participants received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381845|NCT03473925|BG001|Baseline|Navarixin 100 mg + Pembrolizumab 200 mg|Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381846|NCT03473925|BG002|Baseline|Total|Total of all reporting groups
11381847|NCT03473925|FG000|Participant Flow|Navarixin 30 mg + Pembrolizumab 200 mg|Participants received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381848|NCT03473925|FG001|Participant Flow|Navarixin 100 mg + Pembrolizumab 200 mg|Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381849|NCT03473925|OG000|Outcome|Navarixin 30 mg + Pembrolizumab 200 mg|Participants received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381850|NCT03473925|OG001|Outcome|Navarixin 100 mg + Pembrolizumab 200 mg|Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381851|NCT03473925|EG000|Reported Event|Navarixin 30 mg + Pembrolizumab 200 mg|Participants received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381852|NCT03473925|EG001|Reported Event|Navarixin 100 mg + Pembrolizumab 200 mg|Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
11381853|NCT03462641|BG000|Baseline|Sequence A - (Flumazenil at Visit 1)|A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit. Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes on the first visit as treatment. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes on the second visit as treatment.
11381854|NCT03462641|BG001|Baseline|Sequence B - (Placebo at Visit 1)|A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes on the first visit as treatment. Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes on the second visit as treatment.
11381855|NCT03462641|BG002|Baseline|Total|Total of all reporting groups
11381856|NCT03462641|FG000|Participant Flow|Sequence A - (Flumazenil at Visit 1)|A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit. Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes on the first visit as treatment. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes on the second visit as treatment.
11381857|NCT03462641|FG001|Participant Flow|Sequence B - (Placebo at Visit 1)|A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes on the first visit as treatment. Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes on the second visit as treatment.
11381858|NCT03462641|OG000|Outcome|Placebo|MDS-UPDRS PIGD score before treatment administration on the day when placebo was given.
11381859|NCT03462641|OG001|Outcome|Flumazenil|MDS-UPDRS PIGD score before treatment administration on the day when flumazenil was given.
10785490|NCT04377620|EG000|Reported Event|Ruxolitinib 15 mg BID|Ruxolitinib 15 mg BID
10785491|NCT04377620|EG001|Reported Event|Ruxolitinib 5 mg BID|Ruxolitinib 5 mg BID
10785492|NCT04377620|EG002|Reported Event|Placebo|Placebo
10785493|NCT04377620|EG003|Reported Event|Total|Total
10785494|NCT04355169|BG000|Baseline|Naldemedine 1.25 mg|Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785495|NCT04355169|BG001|Baseline|Naldemedine 2.5 mg|Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785496|NCT04355169|BG002|Baseline|Naldemedine 5 mg|Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785497|NCT04355169|BG003|Baseline|Placebo|Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785498|NCT04355169|BG004|Baseline|Total|Total of all reporting groups
10785499|NCT04355169|FG000|Participant Flow|Naldemedine 1.25 mg|Participants received 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.
10785500|NCT04355169|FG001|Participant Flow|Naldemedine 2.5 mg|Participants received 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.
10785501|NCT04355169|FG002|Participant Flow|Naldemedine 5 mg|Participants received 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.
11241032|NCT02484547|FG001|Participant Flow|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241033|NCT02484547|FG002|Participant Flow|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10785502|NCT04355169|FG003|Participant Flow|Placebo|Participants received matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.
10785503|NCT04355169|OG000|Outcome|Naldemedine 1.25 mg|Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785504|NCT04355169|OG001|Outcome|Naldemedine 2.5 mg|Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785505|NCT04355169|OG002|Outcome|Naldemedine 5 mg|Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785506|NCT04355169|OG003|Outcome|Placebo|Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785507|NCT04355169|EG000|Reported Event|Naldemedine 1.25 mg|Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785508|NCT04355169|EG001|Reported Event|Naldemedine 2.5 mg|Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785509|NCT04355169|EG002|Reported Event|Naldemedine 5 mg|Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785510|NCT04355169|EG003|Reported Event|Placebo|Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.
10785511|NCT04338971|BG000|Baseline|IpsiHand Intervention|"This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System.~IpsiHand is a device which includes a robotic exoskeleton that you wear on your forearm and hand, an EEG headset worn on your head, and a tablet which includes therapy software and guides you through daily therapy exercises.~Once a participant completes an initial EEG screening, the participant completes a set of baseline measurements, the IpsiHand BCI device is then provided to the participants and are to be used a minimum of 5 days a week out of 7 days , for a total duration of 12 weeks. Participants are seen monthly throughout the 12-week duration while they are using the IpsiHand. After completion of device use, participants were asked to be evaluated 6 months after discontinuation of the IpsiHand to assess durability effects."
10785512|NCT04338971|FG000|Participant Flow|IpsiHand Intervention|"This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System."
10785513|NCT04338971|OG000|Outcome|IpsiHand Intervention: Change in Fugl-Meyer Assessment of the Upper Extremity|"This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System."
10785514|NCT04338971|OG000|Outcome|IpsiHand Intervention|"This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System."
10785515|NCT04338971|EG000|Reported Event|IpsiHand Intervention|"This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System."
10785516|NCT04310566|BG000|Baseline|All Dispensed Subjects|All subjects dispensed a study lens.
10785517|NCT04310566|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
11381860|NCT03462641|OG000|Outcome|Placebo Responders|A subset of participants that showed a decreased PIGD score in response to placebo treatment.
11381861|NCT03462641|OG001|Outcome|Flumazenil Responders|A subset of participants that showed a decreased PIGD score in response to flumazenil treatment.
11381862|NCT03462641|EG000|Reported Event|Placebo Treatment|10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes. A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit.
11381863|NCT03462641|EG001|Reported Event|Flumazenil Treatment|Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes. A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit.
11381864|NCT03360396|BG000|Baseline|Endobronchial Coils|"Treatment with PneumRx Endobronchial Coil System~Endobronchial Coils: Endobronchial Coil implants"
11381865|NCT03360396|BG001|Baseline|Control|Medically-managed control group
11381866|NCT03360396|BG002|Baseline|Total|Total of all reporting groups
11381867|NCT03360396|FG000|Participant Flow|Endobronchial Coils|"Treatment with PneumRx Endobronchial Coil System~Endobronchial Coils: Endobronchial Coil implants"
11381868|NCT03360396|FG001|Participant Flow|Control|Medically-managed control group
11381869|NCT03360396|OG000|Outcome|Endobronchial Coils|"Treatment with PneumRx Endobronchial Coil System~Endobronchial Coils: Endobronchial Coil implants"
10785518|NCT04310566|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
11381870|NCT03360396|OG001|Outcome|Control|Medically-managed control group
11381871|NCT03360396|EG000|Reported Event|Endobronchial Coils|"Treatment with PneumRx Endobronchial Coil System~Endobronchial Coils: Endobronchial Coil implants"
10785519|NCT04310566|OG000|Outcome|Test|All subjects that wore the Test lens during either the first or second period fo the study
10785520|NCT04310566|OG001|Outcome|Control|All subjects that wore the Control lens during either the first or second period of the study.
10785521|NCT04310566|EG000|Reported Event|Test|All subjects that wore the Test lens during either the first or second period of the study.
11381872|NCT03360396|EG001|Reported Event|Control|Medically-managed control group
11381873|NCT03230097|BG000|Baseline|BI 409306|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
10785522|NCT04310566|EG001|Reported Event|Control|All subjects that wore the Control lens during either the first or second period of the study.
10785523|NCT04206020|BG000|Baseline|Placebo Comparator: SkQ1 Vehicle|Vehicle for SkQ1 Ophthalmic Solution
11381874|NCT03230097|BG001|Baseline|Placebo|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381875|NCT03230097|BG002|Baseline|Total|Total of all reporting groups
11381876|NCT03230097|FG000|Participant Flow|BI 409306|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381877|NCT03230097|FG001|Participant Flow|Placebo|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381878|NCT03230097|OG000|Outcome|BI 409306|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381879|NCT03230097|OG001|Outcome|Placebo|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381880|NCT03230097|EG000|Reported Event|Placebo|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381881|NCT03230097|EG001|Reported Event|BI 409306|Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
11381882|NCT03226067|BG000|Baseline|GKT137831 400mg Once Daily|Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)
10785524|NCT04206020|BG001|Baseline|SkQ1 Ophthalmic Solution|SkQ1 Ophthalmic Solution (1.55µg/mL)
10785525|NCT04206020|BG002|Baseline|Total|Total of all reporting groups
10785526|NCT04206020|FG000|Participant Flow|Placebo Comparator: SkQ1 Vehicle|Vehicle for SkQ1 Ophthalmic Solution
10785527|NCT04206020|FG001|Participant Flow|SkQ1 Ophthalmic Solution|SkQ1 Ophthalmic Solution (1.55µg/mL)
10785528|NCT04206020|OG000|Outcome|Placebo Comparator: SkQ1 Vehicle|Vehicle for SkQ1 Ophthalmic Solution
10785529|NCT04206020|OG001|Outcome|SkQ1 Ophthalmic Solution|SkQ1 Ophthalmic Solution (1.55µg/mL)
10785530|NCT04206020|EG000|Reported Event|Placebo Comparator: SkQ1 Vehicle|Vehicle for SkQ1 Ophthalmic Solution
10785531|NCT04206020|EG001|Reported Event|SkQ1 Ophthalmic Solution|SkQ1 Ophthalmic Solution (1.55µg/mL)
10802068|NCT02953340|FG001|Participant Flow|(Arm 2): Pegfilgrastim and TC|At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10802069|NCT02953340|OG000|Outcome|(Arm 1): SPI-2012 and TC|At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, [3.6 mg granulocyte colony-stimulating factor {G-CSF}] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10802070|NCT02953340|OG001|Outcome|(Arm 2): Pegfilgrastim and TC|At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
10802071|NCT02953340|OG000|Outcome|(Arm 1): SPI-2012 and TC|At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, [3.6 mg granulocyte colony-stimulating factor {G-CSF}] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
10802072|NCT02953340|OG001|Outcome|(Arm 2): Pegfilgrastim and TC|At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation.
10802073|NCT02953340|OG002|Outcome|(Arm 1): SPI-2012 and TC: Follow-up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
10802074|NCT02953340|OG003|Outcome|Arm 2: Pegfilgrastim and TC: Follow-up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment
10802075|NCT02953340|EG000|Reported Event|(Arm 1): SPI-2012 and TC|At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, [3.6 mg G-CSF] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
10802076|NCT02953340|EG001|Reported Event|(Arm 2): Pegfilgrastim and TC|At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
10802077|NCT02953340|EG002|Reported Event|(Arm 1): SPI-2012 and TC: Follow-up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
10802078|NCT02953340|EG003|Reported Event|(Arm 2): Pegfilgrastim and TC: Follow-up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
10802088|NCT02855944|BG000|Baseline|Rucaparib|Patients randomized to the rucaparib arm.
10802089|NCT02855944|BG001|Baseline|Chemotherapy|Patients randomized to the chemotherapy arm.
10802090|NCT02855944|BG002|Baseline|Total|Total of all reporting groups
10802091|NCT02855944|FG000|Participant Flow|Rucaparib|Patients randomized to the rucaparib arm received oral rucaparib 600 mg twice a day (BID) in continuous 28-day cycles.
10785532|NCT04097301|BG000|Baseline|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD)."
10785533|NCT04097301|FG000|Participant Flow|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD)."
10785534|NCT04097301|OG000|Outcome|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD)."
10785535|NCT04097301|OG000|Outcome|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design."
10785536|NCT04097301|OG000|Outcome|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD)"
10785537|NCT04097301|EG000|Reported Event|MLM-CAR44.1 T-cells Infusion|"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3~The dose of iv infused MLM-CAR44.1 T-cells is:~PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD)."
10785538|NCT04054375|BG000|Baseline|Weekly Steroid|"Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM~Prednisone: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM"
10785539|NCT04054375|FG000|Participant Flow|Weekly Steroid|"Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM~Prednisone: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM"
11194477|NCT02152540|OG001|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment~n = 16"
11194478|NCT02152540|EG000|Reported Event|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
10785540|NCT04054375|OG000|Outcome|Weekly Steroid|"Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM~Prednisone: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM"
10785541|NCT04054375|EG000|Reported Event|Weekly Steroid|"Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM~Prednisone: Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM"
11194479|NCT02152540|EG001|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham rTMS: Placebo Device that simulates active rTMS treatment"
11194480|NCT02152605|BG000|Baseline|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11194481|NCT02152605|BG001|Baseline|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
10785542|NCT03953079|BG000|Baseline|GB-102 1 mg/1 mg|Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
10785543|NCT03953079|BG001|Baseline|GB-102 2 mg/1 mg|Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
10785544|NCT03953079|BG002|Baseline|Aflibercept 2 mg|Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
10785545|NCT03953079|BG003|Baseline|Total|Total of all reporting groups
10785546|NCT03953079|FG000|Participant Flow|GB-102 1 mg/1 mg|Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
10785547|NCT03953079|FG001|Participant Flow|GB-102 2 mg/1 mg|Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
10785548|NCT03953079|FG002|Participant Flow|Aflibercept 2 mg|Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
10785549|NCT03953079|OG000|Outcome|GB-102 1 mg/1 mg|Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
10785550|NCT03953079|OG001|Outcome|GB-102 2 mg/1 mg|Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
10785551|NCT03953079|OG002|Outcome|Aflibercept 2 mg|Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
10785552|NCT03953079|OG002|Outcome|Dose|Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
10785553|NCT03953079|EG000|Reported Event|GB-102 1 mg/1 mg|Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
10785554|NCT03953079|EG001|Reported Event|GB-102 2 mg/1 mg|Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
10785555|NCT03953079|EG002|Reported Event|Aflibercept 2 mg|Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
10785556|NCT03922750|BG000|Baseline|Insulin 287 (Without Loading Dose)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785557|NCT03922750|BG001|Baseline|Insulin 287 (With 100% Loading Dose)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785558|NCT03922750|BG002|Baseline|Insulin Glargine U100|Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785559|NCT03922750|BG003|Baseline|Total|Total of all reporting groups
10785560|NCT03922750|FG000|Participant Flow|Insulin 287 (Without Loading Dose)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785561|NCT03922750|FG001|Participant Flow|Insulin 287 (With 100% Loading Dose)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
11194482|NCT02152605|BG002|Baseline|Total|Total of all reporting groups
11381883|NCT03226067|BG001|Baseline|GKT137831 400mg Twice Daily|Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)
11381884|NCT03226067|BG002|Baseline|Placebo Arm|Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)
11381885|NCT03226067|BG003|Baseline|Total|Total of all reporting groups
11381886|NCT03226067|FG000|Participant Flow|GKT137831 400mg Twice Daily|"GKT137831 400mg twice daily~Patients will self-administer 4 capsules in the morning and 4 capsules in the evening.~GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily."
11381887|NCT03226067|FG001|Participant Flow|GKT137831 400mg Once Daily|"GKT137831 400mg once daily~Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.~GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.~Placebo oral capsule: Matching capsules."
11381888|NCT03226067|FG002|Participant Flow|Placebo Arm|"Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.~Placebo oral capsule: Matching capsules."
11381889|NCT03226067|OG000|Outcome|GKT137831 400mg Once Daily|Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)
11381890|NCT03226067|OG001|Outcome|GKT137831 400mg Twice Daily|Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)
11381891|NCT03226067|OG002|Outcome|Placebo Arm|Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)
11381892|NCT03226067|EG000|Reported Event|GKT137831 400mg Twice Daily|"GKT137831 400mg twice daily~Patients will self-administer 4 capsules in the morning and 4 capsules in the evening.~GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily."
11381893|NCT03226067|EG001|Reported Event|GKT137831 400mg Once Daily|"GKT137831 400mg once daily~Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.~GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.~Placebo oral capsule: Matching capsules."
11381894|NCT03226067|EG002|Reported Event|Placebo Arm|"Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.~Placebo oral capsule: Matching capsules."
11381895|NCT03029780|BG000|Baseline|Arm A: Fixed Ratio Combination|Participants recieve a fixed ratio combination (BMS-986237) of nivolumab and ipilimumab in a 3:1 ratio (nivolumab 3 mg/kg and ipilimumab1 mg/kg) every 3 weeks for 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381896|NCT03029780|BG001|Baseline|Arm B: Sequential Combination|Nivolumab 3 mg/kg and ipilimumab 1 mg/kg will be administered sequentially every 3 weeks for up to 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381897|NCT03029780|BG002|Baseline|Total|Total of all reporting groups
11381898|NCT03029780|FG000|Participant Flow|Arm A: Fixed Ratio Combination|Participants recieve a fixed ratio combination (BMS-986237) of nivolumab and ipilimumab in a 3:1 ratio (nivolumab 3 mg/kg and ipilimumab1 mg/kg) every 3 weeks for 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381899|NCT03029780|FG001|Participant Flow|Arm B: Sequential Combination|Nivolumab 3 mg/kg and ipilimumab 1 mg/kg will be administered sequentially every 3 weeks for up to 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381900|NCT03029780|OG000|Outcome|Arm A: Fixed Ratio Combination|Participants recieve a fixed ratio combination (BMS-986237) of nivolumab and ipilimumab in a 3:1 ratio (nivolumab 3 mg/kg and ipilimumab1 mg/kg) every 3 weeks for 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381901|NCT03029780|OG001|Outcome|Arm B: Sequential Combination|"Nivolumab 3 mg/kg and ipilimumab~1 mg/kg will be administered sequentially every 3 weeks for up to 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks."
11381902|NCT03029780|OG001|Outcome|Arm B: Sequential Combination|Nivolumab 3 mg/kg and ipilimumab 1 mg/kg will be administered sequentially every 3 weeks for up to 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381903|NCT03029780|EG000|Reported Event|Arm A: Fixed Ratio Combination|Participants recieve a fixed ratio combination (BMS-986237) of nivolumab and ipilimumab in a 3:1 ratio (nivolumab 3 mg/kg and ipilimumab1 mg/kg) every 3 weeks for 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381904|NCT03029780|EG001|Reported Event|Arm B: Sequential Combination|Nivolumab 3 mg/kg and ipilimumab 1 mg/kg will be administered sequentially every 3 weeks for up to 4 doses. Participants will then receive nivolumab 480 mg flat dose infused over 30 minutes every four weeks.
11381905|NCT03018730|BG000|Baseline|PRX-102|PRX-102 infusion 1 mg/kg every 2 weeks
11381906|NCT03018730|FG000|Participant Flow|PRX-102|PRX-102 (pegunigalsidase alfa): PRX-102 infusion 1 mg/kg every 2 weeks
11381907|NCT03018730|OG000|Outcome|PRX-102|PRX-102 infusion 1 mg/kg every 2 weeks
11381908|NCT03018730|OG000|Outcome|PRX-102 Efficacy Population|PRX-102 infusion 1 mg/kg every 2 weeks
11381909|NCT03018730|OG001|Outcome|PRX-102 Male|PRX-102 infusion 1 mg/kg every 2 weeks
11381910|NCT03018730|OG002|Outcome|PRX-102 Female|PRX-102 infusion 1 mg/kg every 2 weeks
11381911|NCT03018730|EG000|Reported Event|All Patients|PRX-102 infusion 1 mg/kg every 2 weeks
11381912|NCT02968940|BG000|Baseline|Avelumab and Hypofractionated Radiation Therapy(HFRT)|"Avelumab 10 mg/kg intravenously (IV) every 2 weeks.~Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions~Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks~Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions"
10785562|NCT03922750|FG002|Participant Flow|Insulin Glargine U100|Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785563|NCT03922750|OG000|Outcome|Insulin 287 (Without Loading Dose)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785564|NCT03922750|OG001|Outcome|Insulin 287 (With 100% Loading Dose)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785565|NCT03922750|OG002|Outcome|Insulin Glargine U100|Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785566|NCT03922750|EG000|Reported Event|Insulin 287 (Without Loading Dose)|Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785567|NCT03922750|EG001|Reported Event|Insulin 287 (With 100% Loading Dose)|Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785568|NCT03922750|EG002|Reported Event|Insulin Glargine U100|Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
10785569|NCT03910673|BG000|Baseline|30 Minute BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.~BAL performed 30 minutes after start of third infusion dose."
10785570|NCT03910673|BG001|Baseline|75 Minute BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.~BAL performed 75 minutes after start of third infusion dose."
10785571|NCT03910673|BG002|Baseline|2 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.~BAL performed 2 hours after start of third infusion dose."
10785572|NCT03910673|BG003|Baseline|5 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.~BAL performed 5 hours after start of third infusion dose."
10785573|NCT03910673|BG004|Baseline|8 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.~BAL performed 8 hours after start of third infusion dose."
10785574|NCT03910673|BG005|Baseline|Total|Total of all reporting groups
10785575|NCT03910673|FG000|Participant Flow|30 Minute BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 30 minutes after start of third infusion dose.~Fosfomycin disodium: Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt."
10785576|NCT03910673|FG001|Participant Flow|75 Minute BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 75 minutes after start of third infusion dose.~Fosfomycin disodium: Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt."
10785577|NCT03910673|FG002|Participant Flow|2 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 2 hours after start of third infusion dose.~Fosfomycin disodium: Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt."
10785578|NCT03910673|FG003|Participant Flow|5 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 5 hours after start of third infusion dose.~Fosfomycin disodium: Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt."
10785579|NCT03910673|FG004|Participant Flow|8 Hour BAL|"ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 8 hours after start of third infusion dose.~Fosfomycin disodium: Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt."
10785580|NCT03910673|OG000|Outcome|ZTI-01 All Participants|ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.
10785581|NCT03910673|EG000|Reported Event|ZTI-01 All Participants|ZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium.
10785582|NCT03885999|BG000|Baseline|Fecobionics Studies|Fecobionics: Fecobionics is a new device for studying defecation
10785583|NCT03885999|FG000|Participant Flow|Fecobionics Studies|Fecobionics: Fecobionics is a new device for studying defecation
10785584|NCT03885999|OG000|Outcome|Fecobionics Studies|Fecobionics: Fecobionics is a new device for studying defecation
10785585|NCT03885999|EG000|Reported Event|Fecobionics Studies|Fecobionics: Fecobionics is a new device for studying defecation
10964675|NCT00878722|BG005|Baseline|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10785586|NCT03882970|BG000|Baseline|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10785587|NCT03882970|BG001|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10785588|NCT03882970|BG002|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week SC.
10785589|NCT03882970|BG003|Baseline|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785590|NCT03882970|BG004|Baseline|Total|Total of all reporting groups
10785591|NCT03882970|FG000|Participant Flow|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10785592|NCT03882970|FG001|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10785593|NCT03882970|FG002|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week SC.
10785594|NCT03882970|FG003|Participant Flow|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785595|NCT03882970|OG000|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10785596|NCT03882970|OG001|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week SC.
10785597|NCT03882970|OG002|Outcome|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785598|NCT03882970|OG000|Outcome|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10785599|NCT03882970|OG001|Outcome|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785600|NCT03882970|OG001|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once a week.
10785601|NCT03882970|OG002|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week SC.
10785602|NCT03882970|OG003|Outcome|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785603|NCT03882970|EG000|Reported Event|5 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10785604|NCT03882970|EG001|Reported Event|10 mg Tirzepatide|5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
10785605|NCT03882970|EG002|Reported Event|15 mg Tirzepatide|15 mg tirzepatide administered SC once a week SC.
10785606|NCT03882970|EG003|Reported Event|Insulin Degludec|"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.~The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values."
10785607|NCT03879525|BG000|Baseline|EMR Group|"Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.~EMR-based-interventional method: Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic."
10785608|NCT03879525|BG001|Baseline|Phone Group|"Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.~Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method."
10785609|NCT03879525|BG002|Baseline|Total|Total of all reporting groups
10785610|NCT03879525|FG000|Participant Flow|EMR Group|"Participants assigned to this arm will complete the questionnaires in the Electronic Medical Record (EMR) using the EMR-based-interventional method.~EMR-based-interventional method: Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic."
10785611|NCT03879525|FG001|Participant Flow|Phone Group|"Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.~Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method."
10785612|NCT03879525|OG000|Outcome|EMR Group|"Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.~EMR-based-interventional method: Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic."
10785613|NCT03879525|OG000|Outcome|Phone Group|"Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.~Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method."
10785614|NCT03879525|OG001|Outcome|Phone Group|"Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.~Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method."
10785615|NCT03879525|EG000|Reported Event|EMR Group|"Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.~EMR-based-interventional method: Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic."
10785616|NCT03879525|EG001|Reported Event|Phone Group|"Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.~Telephone-based-standard method: Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method."
10785617|NCT03867734|BG000|Baseline|2g Aztreonam|"Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea~Aztreonam: 2g IM Aztreonam"
10785618|NCT03867734|FG000|Participant Flow|2g Aztreonam|"Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea~Aztreonam: 2g IM Aztreonam"
10785619|NCT03867734|OG000|Outcome|Pharyngeal Gonorrhea -- Evaluable Population|Subjects who were Pharyngeal Gonorrhea Culture Positive at Enrollment and Received 2g Aztreonam intramuscularly (IM) and Returned for Test of Cure (TOC)
10785620|NCT03867734|OG000|Outcome|Efficacy of 2g Aztreonam for Urethral Gonorrhea|"Subjects with culture-positive urethral gonorrhea who received 2g Aztreonam IM and returned for TOC~Aztreonam: 2g IM Aztreonam"
10785621|NCT03867734|OG001|Outcome|Efficacy of 2g Aztreonam for Rectal Gonorrhea|Subjects with culture-positive gonorrhea of the rectum, treated with 2g Aztreonam and returned for TOC
10785622|NCT03867734|OG000|Outcome|2g Aztreonam|"All subjects who received 2g Aztreonam IM for the treatment of gonorrhea~Aztreonam: 2g IM Aztreonam"
10785623|NCT03867734|OG000|Outcome|2g Aztreonam|"Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea~Aztreonam: 2g IM Aztreonam"
10785624|NCT03867734|EG000|Reported Event|2g Aztreonam|"Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea~Aztreonam: 2g IM Aztreonam"
10802092|NCT02855944|FG001|Participant Flow|Chemotherapy|Patients randomized to the chemotherapy arm received either weekly intravenous (IV) paclitaxel or IV platinum-based chemotherapy per investigator choice and per standard of care. The starting dose of weekly paclitaxel was 60 to 80 mg/m2 administered via IV infusion (ie, on Days 1, 8, and 15) in each 28-day cycle (with a week break from dosing on Day 22 in each cycle). The dosage and administration of single-agent cisplatin or carboplatin or doublet carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine IV infusion followed institutional guidelines for each agent. Upon progression of disease, patients had the option to cross over to rucaparib and receive oral rucaparib 600 mg BID in continuous 28-day cycles.
10802093|NCT02855944|OG000|Outcome|Rucaparib|Patients randomized to the rucaparib arm.
10802094|NCT02855944|OG001|Outcome|Chemotherapy|Patients randomized to the chemotherapy arm.
10802095|NCT02855944|EG000|Reported Event|Rucaparib (Treatment Part)|Patients randomized to the rucaparib arm in the Treatment Part of the study.
10802096|NCT02855944|EG001|Reported Event|Chemotherapy (Treatment Part)|Patients randomized to the chemotherapy arm in the Treatment Part of the study.
10802097|NCT02855944|EG002|Reported Event|Rucaparib (Crossover Part)|Patients randomized to chemotherapy who then crossed over upon disease progression and were treated with rucaparib.
10785625|NCT03781778|BG000|Baseline|1-Active (Resistant Starch)|Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785626|NCT03781778|BG001|Baseline|2-Control (Regular Starch)|Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785627|NCT03781778|BG002|Baseline|Total|Total of all reporting groups
10785628|NCT03781778|FG000|Participant Flow|1-Active (Resistant Starch)|Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785629|NCT03781778|FG001|Participant Flow|2-Control (Regular Starch)|Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785630|NCT03781778|OG000|Outcome|1-Active (Resistant Starch)|Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785631|NCT03781778|OG001|Outcome|2-Control (Regular Starch)|Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785632|NCT03781778|EG000|Reported Event|1-Active (Resistant Starch)|Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785633|NCT03781778|EG001|Reported Event|2-Control (Regular Starch)|Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.
10785634|NCT03764735|BG000|Baseline|SkQ1 Vehicle|Vehicle for SkQ1 ophthalmic solution
10785635|NCT03764735|BG001|Baseline|Low Dose - SkQ1|SkQ1 Low dose ophthalmic solution
10785636|NCT03764735|BG002|Baseline|High Dose - SkQ1|SkQ1 High Dose ophthalmic solution
10785637|NCT03764735|BG003|Baseline|Total|Total of all reporting groups
10785638|NCT03764735|FG000|Participant Flow|SkQ1 Vehicle|Vehicle for SkQ1 ophthalmic solution
10785639|NCT03764735|FG001|Participant Flow|Low Dose - SkQ1|SkQ1 Low dose ophthalmic solution
10785640|NCT03764735|FG002|Participant Flow|High Dose - SkQ1|SkQ1 High Dose ophthalmic solution
10785641|NCT03764735|OG000|Outcome|SkQ1 Vehicle|Vehicle for SkQ1 ophthalmic solution
10785642|NCT03764735|OG001|Outcome|Low Dose - SkQ1|SkQ1 Low dose ophthalmic solution
10785643|NCT03764735|OG002|Outcome|High Dose - SkQ1|SkQ1 High Dose ophthalmic solution
10785644|NCT03764735|EG000|Reported Event|SkQ1 Vehicle|Vehicle for SkQ1 ophthalmic solution
10785645|NCT03764735|EG001|Reported Event|Low Dose - SkQ1|SkQ1 Low dose ophthalmic solution
10785646|NCT03764735|EG002|Reported Event|High Dose - SkQ1|SkQ1 High Dose ophthalmic solution
10785647|NCT03730480|BG000|Baseline|Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes|"All subjects test CONTOUR NEXT and Contour TV3 BGMS.~Contour Next BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.~Contour TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.~Subjects with diabetes get a venipuncture and staff tests the venous blood with both BGMS."
10785648|NCT03730480|FG000|Participant Flow|Contour Next and Contour TV3 -Subjects With and Without Diabetes|"All subjects test CONTOUR NEXT BGMS and Contour TV3.~Contour Next BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject.~Contour TV3 BGMS: same testing as Contour Next.~Subjects with diabetes get a venipuncture and staff tests the venous blood on both BGMS."
10785649|NCT03730480|OG000|Outcome|Contour Next and Contour TV3 -Subjects With and Without Diabetes|"All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS.~Contour Next BGMS and Contour TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Subjects with diabetes get a venipuncture and staff tests the venous blood."
10785650|NCT03730480|OG000|Outcome|Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes|All subjects respond to statements about CONTOUR NEXT BGMS CONTOUR TV3 BGMS.
10785651|NCT03730480|EG000|Reported Event|Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes|"All subjects test CONTOUR NEXT BGMS and CONTOUR TV3 BGMS.~Contour Next BGMS and CONTOUR TV3 BGMS testing by subjects with and without Diabetes: All subjects perform self fingerstick test and alternative site test on the palm. Staff performs fingerstick test on subject. Subjects with diabetes get a venipuncture and staff tests the venous blood."
10785652|NCT03713073|BG000|Baseline|All Participants|"The study is a split-mouth design. For each participant, there were 2 palatal wound sites (one on the right side and one on the left side), and for each participant, allogenic amnion chorion membrane (ACM) was placed on one of the wound sites and collagen dressing was placed on the other wound site. In other words, each participant received both interventions, and the interventions were received at the same time. The side of placement of the two interventions was randomized.~Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Collagen dressing is used to cover wounds in dental surgery."
10785653|NCT03713073|FG000|Participant Flow|All Participants|"The study is a split-mouth design. For each participant, there were 2 palatal wound sites (one on the right side and one on the left side), and for each participant, allogenic amnion chorion membrane (ACM) was placed on one of the wound sites and collagen dressing was placed on the other wound site. In other words, each participant received both interventions, and the interventions were received at the same time. The side of placement of the two interventions was randomized.~Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.~Collagen dressing is used to cover wounds in dental surgery."
10964676|NCT00878722|BG006|Baseline|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10785654|NCT03713073|OG000|Outcome|Allogenic Amnion Chorion Membrane|"Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.~Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery."
10785655|NCT03713073|OG001|Outcome|Collagen Dressing|"Collagen dressing is used to cover wounds in dental surgery.~Collagen dressing: Collagen dressing is used to cover wounds in dental surgery."
10785656|NCT03713073|EG000|Reported Event|Allogenic Amnion Chorion Membrane|"Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.~Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery."
10785657|NCT03713073|EG001|Reported Event|Collagen Dressing|"Collagen dressing is used to cover wounds in dental surgery.~Collagen dressing: Collagen dressing is used to cover wounds in dental surgery."
10785658|NCT03713034|BG000|Baseline|PlayTest! Game|"PlayTest! is an interactive world in which the player, using an avatar they have created, travels through life in high school. They face challenges that bring different risks and benefits, requiring them to practice decision-making skills. The player learns skills that aim to empower them to make safe choices in situations that may otherwise increase their risk for HIV/STI infection. The game also provides opportunities for the player to practice advocating for their health by modeling a conversation with a medical professional. PlayTest! incorporates evidence-based tools for behavior change including social learning theory and self-efficacy. message framing, motivational interviewing to identify the variables that must be targeted to increase HTC among adolescents.~Participants who were randomized to the intervention arm of the project, played the PlayTest! game on their assigned iPad, once per week for an hour, over the course of 4-5 weeks."
10785659|NCT03713034|BG001|Baseline|Control Games|Participants who were randomized to the control arm were provided a menu of attention control games to choose from on their iPads that had no content related to HTC or HIV. Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. Participants played the choice of control games on their assigned iPad, once per week for and hour, over the course of 4-5 weeks.
10785660|NCT03713034|BG002|Baseline|Total|Total of all reporting groups
10785661|NCT03713034|FG000|Participant Flow|PlayTest! Game|Participants who were randomized to the intervention arm of the project, played the PlayTest! game on their assigned iPad, once per week for an hour, over the course of 4-5 weeks.
10785662|NCT03713034|FG001|Participant Flow|Control Games|Participants who were randomized to the control arm were provided a menu of attention control games to choose from on their iPads that had no content related to HTC or HIV. Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. Participants played the choice of control games on their assigned iPad, once per week for and hour, over the course of 4-5 weeks.
10785663|NCT03713034|OG000|Outcome|PlayTest! Game|Participants who were randomized to the intervention arm of the project, played the PlayTest! game on their assigned iPad, once per week for an hour, over the course of 4-5 weeks.
10785664|NCT03713034|OG001|Outcome|Control Games|Participants who were randomized to the control arm were provided a menu of attention control games to choose from on their iPads that had no content related to HTC or HIV. Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. Participants played the choice of control games on their assigned iPad, once per week for and hour, over the course of 4-5 weeks.
10785665|NCT03713034|OG000|Outcome|Active Game|"PlayTest! is an interactive world in which the player, using an avatar they have created, travels through life in high school. They face challenges that bring different risks and benefits, requiring them to practice decision-making skills. The player learns skills that aim to empower them to make safe choices in situations that may otherwise increase their risk for HIV/STI infection. The game also provides opportunities for the player to practice advocating for their health by modeling a conversation with a medical professional. PlayTest! incorporates evidence-based tools for behavior change including social learning theory and self-efficacy. message framing, motivational interviewing to identify the variables that must be targeted to increase HTC among adolescents.~PlayTest!: Participants in the PlayTest! intervention arm played the game on their assigned iPads once per week for an hour over the course of 4-5 weeks."
10785666|NCT03713034|OG001|Outcome|Control Game|"Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. The control games contained not relevant content related to HIV Testing and Counseling.~Control games: Participants in the control arm played the games on their assigned iPads once per week for an hour over the course of 4-5 weeks."
11194483|NCT02152605|FG000|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
10785667|NCT03713034|EG000|Reported Event|PlayTest! Game|Participants who were randomized to the intervention arm of the project, played the PlayTest! game on their assigned iPad, once per week for an hour, over the course of 4-5 weeks.
10785668|NCT03713034|EG001|Reported Event|Control Games|Participants who were randomized to the control arm were provided a menu of attention control games to choose from on their iPads that had no content related to HTC or HIV. Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. Participants played the choice of control games on their assigned iPad, once per week for and hour, over the course of 4-5 weeks.
10802098|NCT02851407|BG000|Baseline|Defibrotide Prophylaxis|Defibrotide was administered intravenously at a dose of 6.25mg/kg/day in 4 divided doses by IV infusion over 2 hours in addition to best supportive care within 24 hours before the first dose of the conditioning regimen and continued (for those participants without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post-HSCT.
11194484|NCT02152605|FG001|Participant Flow|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11381913|NCT02968940|FG000|Participant Flow|Avelumab and Hypofractionated Radiation Therapy(HFRT)|"Avelumab 10 mg/kg intravenously (IV) every 2 weeks.~Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions~Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks~Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions"
11381914|NCT02968940|OG000|Outcome|Avelumab and Hypofractionated Radiation Therapy(HFRT)|"Avelumab 10 mg/kg intravenously (IV) every 2 weeks.~Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions~Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks~Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions"
11381915|NCT02968940|EG000|Reported Event|Avelumab and Hypofractionated Radiation Therapy(HFRT)|"Avelumab 10 mg/kg intravenously (IV) every 2 weeks.~Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions~Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks~Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions"
11381916|NCT02893930|BG000|Baseline|Arm A (MLN0128)|Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11381917|NCT02893930|FG000|Participant Flow|Arm A (MLN0128)|Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11381918|NCT02893930|OG000|Outcome|Arm A (MLN0128)|Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11381919|NCT02893930|EG000|Reported Event|Arm A (MLN0128)|Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11381920|NCT02890355|BG000|Baseline|Arm I (Veliparib and mFOLFIRI)|"Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Veliparib: Given PO"
11381921|NCT02890355|BG001|Baseline|Arm II (FOLFIRI)|"Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3.~Fluorouracil: Given IV~Fluorouracil: Given IV bolus~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV"
11381922|NCT02890355|BG002|Baseline|Total|Total of all reporting groups
11381923|NCT02890355|FG000|Participant Flow|Arm I (Veliparib and mFOLFIRI)|"Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Veliparib: Given PO"
11381924|NCT02890355|FG001|Participant Flow|Arm II (FOLFIRI)|"Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3.~Fluorouracil: Given IV~Fluorouracil: Given IV bolus~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV"
11381925|NCT02890355|OG000|Outcome|Arm I (Veliparib and mFOLFIRI)|"Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Veliparib: Given PO"
11381926|NCT02890355|OG001|Outcome|Arm II (FOLFIRI)|"Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3.~Fluorouracil: Given IV~Fluorouracil: Given IV bolus~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV"
11381927|NCT02890355|OG000|Outcome|Arm I Veliparib and mFOLFIRI|"Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Veliparib: Given PO"
11381928|NCT02890355|OG001|Outcome|Arm II FOLFIRI|"Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3.~Fluorouracil: Given IV~Fluorouracil: Given IV bolus~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV"
11381929|NCT02890355|EG000|Reported Event|Arm I Veliparib and mFOLFIRI|"Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Veliparib: Given PO"
11381930|NCT02890355|EG001|Reported Event|Arm II FOLFIRI|"Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3.~Fluorouracil: Given IV~Fluorouracil: Given IV bolus~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV"
11381931|NCT02853305|BG000|Baseline|Pembrolizumab + ST Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381932|NCT02853305|BG001|Baseline|Pembrolizumab (Pembro)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
11381933|NCT02853305|BG002|Baseline|ST Chemotherapy (Chemo)|Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381934|NCT02853305|BG003|Baseline|Total|Total of all reporting groups
11381935|NCT02853305|FG000|Participant Flow|Pembrolizumab + ST Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381936|NCT02853305|FG001|Participant Flow|Pembrolizumab (Pembro)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
11381937|NCT02853305|FG002|Participant Flow|ST Chemotherapy (Chemo)|Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381938|NCT02853305|OG000|Outcome|Pembrolizumab + ST Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381939|NCT02853305|OG001|Outcome|Pembrolizumab (Pembro)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
11381940|NCT02853305|OG002|Outcome|ST Chemotherapy (Chemo)|Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381941|NCT02853305|EG000|Reported Event|Pembrolizumab + ST Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381942|NCT02853305|EG001|Reported Event|Pembrolizumab (Pembro)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
11381943|NCT02853305|EG002|Reported Event|ST Chemotherapy (Chemo)|Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
11381944|NCT02803593|BG000|Baseline|Control|Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
11381945|NCT02803593|BG001|Baseline|TICAA|Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
11381946|NCT02803593|BG002|Baseline|Total|Total of all reporting groups
11381947|NCT02803593|FG000|Participant Flow|Control|Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
10802099|NCT02851407|BG001|Baseline|Best Supportive Care|"Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and participant need, was administered on the first day of conditioning and continued until Day +30 post HSCT or hospital discharge, whichever was sooner, or diagnosis of VOD, if applicable.~Best Supportive Care"
10802100|NCT02851407|BG002|Baseline|Total|Total of all reporting groups
10964677|NCT00878722|BG007|Baseline|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
11381948|NCT02803593|FG001|Participant Flow|TICAA|Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
11381949|NCT02803593|OG000|Outcome|Control|Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
11381950|NCT02803593|OG001|Outcome|TICAA|Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
11381951|NCT02803593|EG000|Reported Event|Control|Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
11381952|NCT02803593|EG001|Reported Event|TICAA|Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
11381953|NCT02663908|BG000|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.
11381954|NCT02663908|BG001|Baseline|Leuprolide 22.5 mg|Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
11381955|NCT02663908|BG002|Baseline|Total|Total of all reporting groups
11381956|NCT02663908|FG000|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.
11381957|NCT02663908|FG001|Participant Flow|Leuprolide 22.5 mg|Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
11381958|NCT02663908|OG000|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.
11381959|NCT02663908|OG001|Outcome|Leuprolide 22.5 mg|Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
11381960|NCT02663908|EG000|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.
11381961|NCT02663908|EG001|Reported Event|Leuprolide 22.5 mg|Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
11381962|NCT02650284|BG000|Baseline|Bicompartmental Knee Replacement (BKR)|"Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement"
11381963|NCT02650284|BG001|Baseline|Total Knee Replacement (TKR)|"Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Stryker Triathlon Primary Total Knee System: Total Knee Replacement"
11381964|NCT02650284|BG002|Baseline|Total|Total of all reporting groups
11381965|NCT02650284|FG000|Participant Flow|Bicompartmental Knee Replacement (BKR)|"Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement"
11381966|NCT02650284|FG001|Participant Flow|Total Knee Replacement (TKR)|"Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Stryker Triathlon Primary Total Knee System: Total Knee Replacement"
11381967|NCT02650284|OG000|Outcome|Bicompartmental Knee Replacement (BKR)|"Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement"
11381968|NCT02650284|OG001|Outcome|Total Knee Replacement (TKR)|"Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Stryker Triathlon Primary Total Knee System: Total Knee Replacement"
11381969|NCT02650284|EG000|Reported Event|Bicompartmental Knee Replacement (BKR)|"Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement"
11381970|NCT02650284|EG001|Reported Event|Total Knee Replacement (TKR)|"Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako~Stryker Triathlon Primary Total Knee System: Total Knee Replacement"
11381971|NCT02642042|BG000|Baseline|Treatment (Trametinib, Docetaxel)|"Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11381972|NCT02642042|FG000|Participant Flow|Treatment (Trametinib, Docetaxel)|"Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
10964678|NCT00878722|BG008|Baseline|Total|Total of all reporting groups
11241034|NCT02484547|FG003|Participant Flow|BIIB037 Late Start: Low Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11381973|NCT02642042|OG000|Outcome|Treatment (Trametinib, Docetaxel)|"Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
11381974|NCT02642042|EG000|Reported Event|Treatment (Trametinib, Docetaxel)|"Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Trametinib: Given PO"
10964679|NCT00878722|FG000|Participant Flow|Arm A, Step 1|PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
10785669|NCT03654404|BG000|Baseline|Positive Psychology|"Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.~At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).~Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.~Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities."
10785670|NCT03654404|FG000|Participant Flow|Positive Psychology|"Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.~At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).~Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.~Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities."
10785671|NCT03654404|OG000|Outcome|Positive Psychology|"Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.~At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).~Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.~Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities."
10785672|NCT03654404|EG000|Reported Event|Positive Psychology|"Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.~At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).~Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.~Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities."
10785673|NCT03567057|BG000|Baseline|Placebo/274 mg ADS-5102|Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785674|NCT03567057|BG001|Baseline|137 mg ADS-5102/274 mg ADS-5102|Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785675|NCT03567057|BG002|Baseline|274 mg ADS-5102/274 mg ADS-5102|Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
10785676|NCT03567057|BG003|Baseline|Total|Total of all reporting groups
11194485|NCT02152605|OG000|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
10785677|NCT03567057|FG000|Participant Flow|Placebo/274 mg ADS-5102|Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785678|NCT03567057|FG001|Participant Flow|137 mg ADS-5102/274 mg ADS-5102|Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785679|NCT03567057|FG002|Participant Flow|274 mg ADS-5102/274 mg ADS-5102|Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
10785680|NCT03567057|OG000|Outcome|Placebo/274 mg ADS-5102|Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785681|NCT03567057|OG001|Outcome|137 mg ADS-5102/274 mg ADS-5102|Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785682|NCT03567057|OG002|Outcome|274 mg ADS-5102/274 mg ADS-5102|Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
10785683|NCT03567057|EG000|Reported Event|Placebo/274 mg ADS-5102|Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785684|NCT03567057|EG001|Reported Event|137 mg ADS-5102/274 mg ADS-5102|Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
10785685|NCT03567057|EG002|Reported Event|274 mg ADS-5102/274 mg ADS-5102|Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
10785686|NCT03548987|BG000|Baseline|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
10964680|NCT00878722|FG001|Participant Flow|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
11194486|NCT02152605|OG001|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11194487|NCT02152605|OG001|Outcome|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11194488|NCT02152605|EG000|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11194489|NCT02152605|EG001|Reported Event|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
11202210|NCT02206061|OG000|Outcome|School-Based Asthma Care for Teens (SB-ACT)|"SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.~The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.~School-Based Asthma Care for Teens (SB-ACT)"
11202211|NCT02206061|OG001|Outcome|Directly Observed Therapy|"For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).~Directly Observed Therapy"
11382004|NCT02535338|BG000|Baseline|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382005|NCT02535338|BG001|Baseline|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
10850641|NCT00303719|OG001|Outcome|Standard Risk Patients|Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome,Chronic myeloproliferative disorder
11202212|NCT02206061|OG002|Outcome|Asthma Education|"Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.~Asthma Education"
11382006|NCT02535338|BG002|Baseline|Total|Total of all reporting groups
11382007|NCT02535338|FG000|Participant Flow|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382008|NCT02535338|FG001|Participant Flow|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382009|NCT02535338|OG000|Outcome|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11202375|NCT02207244|EG006|Reported Event|Placebo Then Guselkumab 100 mg (Week 28 - 264)|Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
11382010|NCT02535338|OG001|Outcome|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382011|NCT02535338|OG000|Outcome|Treatment (Erlotinib Hydrochloride, Onalespib Lactate)|"Patients receive 150 erlotinib hydrochloride PO daily and starting dose of 150 mg/m2 onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382012|NCT02535338|OG001|Outcome|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 120 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382013|NCT02535338|OG000|Outcome|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies"
11382014|NCT02535338|OG001|Outcome|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 120 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies"
11382015|NCT02535338|OG000|Outcome|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 erlotinib hydrochloride PO daily and 150 mg/m2 of onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382016|NCT02535338|OG000|Outcome|Treatment (Erlotinib Hydrochloride, Onalespib Lactate)|"Patients receive 150 erlotinib hydrochloride PO daily and 120 mg/m2 of onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382017|NCT02535338|EG000|Reported Event|Dose Level 1 - Onalespib IV 150 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
10964681|NCT00878722|FG002|Participant Flow|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
11382018|NCT02535338|EG001|Reported Event|Dose Level -1 - Onalespib IV 120 mg/m2|"Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Onalespib Lactate: Given IV~Pharmacological Study: Correlative studies"
11382019|NCT02500797|BG000|Baseline|Initial Single|Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382020|NCT02500797|BG001|Baseline|Initial Dual|Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382021|NCT02500797|BG002|Baseline|LPS Single|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382022|NCT02500797|BG003|Baseline|LPS Dual|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382023|NCT02500797|BG004|Baseline|UPS/MFH Single|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382024|NCT02500797|BG005|Baseline|UPS/MFH Dual|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382025|NCT02500797|BG006|Baseline|GIST Single|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382026|NCT02500797|BG007|Baseline|GIST Dual|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382027|NCT02500797|BG008|Baseline|Total|Total of all reporting groups
11382028|NCT02500797|FG000|Participant Flow|Initial Cohort - Arm I (Nivolumab)|Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
11382029|NCT02500797|FG001|Participant Flow|Initial Cohort - Arm II (Nivolumab, Ipilimumab)|Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382030|NCT02500797|FG002|Participant Flow|Expansion LPS Cohort - Arm I (Nivolumab)|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to LPS Cohort - Arm II.
11382031|NCT02500797|FG003|Participant Flow|Expansion LPS Cohort - Arm II (Nivolumab, Ipilimumab)|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382032|NCT02500797|FG004|Participant Flow|Expansion UPS/MFH Cohort - Arm I (Nivolumab)|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to UPS/MFH Cohort - Arm II.
11382033|NCT02500797|FG005|Participant Flow|Expansion UPS/MFH Cohort - Arm II (Nivolumab, Ipilimumab)|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382034|NCT02500797|FG006|Participant Flow|Expansion GIST Cohort - Arm I (Nivolumab)|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to GIST Cohort - Arm II.
11382035|NCT02500797|FG007|Participant Flow|Expansion GIST Cohort - Arm II (Nivolumab, Ipilimumab)|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382036|NCT02500797|OG000|Outcome|Initial Single|Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382037|NCT02500797|OG001|Outcome|Initial Dual|Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11194490|NCT02152631|BG000|Baseline|Abemaciclib|200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
11194491|NCT02152631|BG001|Baseline|Erlotinib|150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
11382038|NCT02500797|OG002|Outcome|LPS Single|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
10850642|NCT00303719|EG000|Reported Event|High Risk Patients|Patients with refractory leukemia or MDS
10964682|NCT00878722|FG003|Participant Flow|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
11194492|NCT02152631|BG002|Baseline|Total|Total of all reporting groups
11194493|NCT02152631|FG000|Participant Flow|Abemaciclib|200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
11194494|NCT02152631|FG001|Participant Flow|Erlotinib|150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
11194495|NCT02152631|OG000|Outcome|Abemaciclib|200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
11194496|NCT02152631|OG001|Outcome|Erlotinib|150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
11194497|NCT02152631|EG000|Reported Event|Abemaciclib|200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
10785687|NCT03548987|BG001|Baseline|Placebo|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
10785688|NCT03548987|BG002|Baseline|Total|Total of all reporting groups
10785689|NCT03548987|FG000|Participant Flow|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
10785690|NCT03548987|FG001|Participant Flow|Placebo|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
10785691|NCT03548987|OG000|Outcome|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
10785692|NCT03548987|OG001|Outcome|Placebo|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
10785693|NCT03548987|EG000|Reported Event|Semaglutide: Run-in Period|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in run-in period (week 0 to week 20) with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.
10785694|NCT03548987|EG001|Reported Event|Semaglutide 2.4: Treatment Period|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 535 participants were continued to receive once weekly semaglutide s.c 2.4 mg until week 68.
10785695|NCT03548987|EG002|Reported Event|Placebo: Treatment Period|Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 268 participants were switched to receive once weekly placebo until week 68.
10785696|NCT03548064|BG000|Baseline|Oral 5 µg dmLT|"5 µg of dmLT administered orally on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785697|NCT03548064|BG001|Baseline|Oral 25 µg of dmLT|"25 µg of dmLT administered orally on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785698|NCT03548064|BG002|Baseline|Oral Placebo|"Placebo administered orally on Days 1, 15, and 29.~Placebo: Sodium bicarbonate buffer is a solution of 2 g sodium bicarbonate in 150 mL of sterile water for injection."
11194498|NCT02152631|EG001|Reported Event|Erlotinib|150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
11194499|NCT02152696|BG000|Baseline|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring"
11194500|NCT02152696|BG001|Baseline|Uterine Evacuation With MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11241035|NCT02484547|FG004|Participant Flow|BIIB037 Late Start: High Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
10785699|NCT03548064|BG003|Baseline|Sublingual 5 µg of dmLT|"5 µg of dmLT administered sublingually on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785700|NCT03548064|BG004|Baseline|Sublingual 25 µg of dmLT|"25 µg of dmLT administered sublingually on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785701|NCT03548064|BG005|Baseline|Sublingual Placebo|"Placebo administered sublingually on Days 1, 15, and 29.~Placebo: 0.9% Sodium Chloride, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride 9 mg and may contain hydrochloric acid and/or sodium hydroixde for pH adjustment (pH 5.3, range 4.5 - 7.0)."
10785702|NCT03548064|BG006|Baseline|Intradermal 0.3 µg of dmLT|0.3 µg of dmLT administered intradermally on Days 1, 22, and 43. Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
10785703|NCT03548064|BG007|Baseline|Intradermal Placebo|"Placebo administered intradermally on Days 1, 22, and 43.~Placebo: 0.9% Sodium Chloride, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride 9 mg and may contain hydrochloric acid and/or sodium hydroixde for pH adjustment (pH 5.3, range 4.5 - 7.0)."
10785704|NCT03548064|BG008|Baseline|Total|Total of all reporting groups
10785705|NCT03548064|FG000|Participant Flow|Oral 5 µg dmLT|"5 µg of dmLT administered orally on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785706|NCT03548064|FG001|Participant Flow|Oral 25 µg of dmLT|"25 µg of dmLT administered orally on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785707|NCT03548064|FG002|Participant Flow|Oral Placebo|"Placebo administered orally on Days 1, 15, and 29.~Placebo: Sodium bicarbonate buffer is a solution of 2 g sodium bicarbonate in 150 mL of sterile water for injection."
10785708|NCT03548064|FG003|Participant Flow|Sublingual 5 µg of dmLT|"5 µg of dmLT administered sublingually on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785709|NCT03548064|FG004|Participant Flow|Sublingual 25 µg of dmLT|"25 µg of dmLT administered sublingually on Days 1, 15, and 29.~Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules."
10785710|NCT03548064|FG005|Participant Flow|Sublingual Placebo|"Placebo administered sublingually on Days 1, 15, and 29.~Placebo: 0.9% Sodium Chloride, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride 9 mg and may contain hydrochloric acid and/or sodium hydroixde for pH adjustment (pH 5.3, range 4.5 - 7.0)."
10785711|NCT03548064|FG006|Participant Flow|Intradermal 0.3 µg of dmLT|0.3 µg of dmLT administered intradermally on Days 1, 22, and 43. Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) enterotoxigenic Escherichia coli (ETEC) Vaccine: LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
11194501|NCT02152696|BG002|Baseline|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
11194502|NCT02152696|BG003|Baseline|Total|Total of all reporting groups
11194503|NCT02152696|FG000|Participant Flow|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring"
10785712|NCT03548064|FG007|Participant Flow|Intradermal Placebo|"Placebo administered intradermally on Days 1, 22, and 43.~Placebo: 0.9% Sodium Chloride, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride 9 mg and may contain hydrochloric acid and/or sodium hydroixde for pH adjustment (pH 5.3, range 4.5 - 7.0)."
10785713|NCT03548064|OG000|Outcome|Oral 5 µg dmLT|5 µg of dmLT administered orally on Days 1, 15, and 29.
10785714|NCT03548064|OG001|Outcome|Oral 25 µg dmLT|25 µg of dmLT administered orally on Days 1, 15, and 29.
10785715|NCT03548064|OG002|Outcome|Oral Placebo|Placebo administered orally on Days 1, 15, and 29.
10785716|NCT03548064|OG000|Outcome|Sublingual 5 µg of dmLT|5 µg of dmLT administered sublingually on Days 1, 15, and 29.
10785717|NCT03548064|OG001|Outcome|Sublingual 25 µg of dmLT|25 µg of dmLT administered sublingually on Days 1, 15, and 29.
10785718|NCT03548064|OG002|Outcome|Sublingual Placebo|Placebo administered sublingually on Days 1, 15, and 29.
11194504|NCT02152696|FG001|Participant Flow|Uterine Evacuation With MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11194505|NCT02152696|FG002|Participant Flow|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
11194506|NCT02152696|OG000|Outcome|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring"
11194507|NCT02152696|OG001|Outcome|Uterine Evacuation With MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11194508|NCT02152696|OG002|Outcome|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
11194509|NCT02152696|EG000|Reported Event|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring"
10785719|NCT03548064|OG000|Outcome|Intradermal 0.3 µg dmLT|0.3 µg of dmLT administered intradermally on Days 1, 22, and 43.
10785720|NCT03548064|OG001|Outcome|Intradermal Placebo|Placebo administered intradermally on Days 1, 22, and 43.
10785721|NCT03548064|OG001|Outcome|Oral 25 µg of dmLT|25 µg of dmLT administered orally on Days 1, 15, and 29.
10785722|NCT03548064|OG003|Outcome|Sublingual 5 µg of dmLT|5 µg of dmLT administered sublingually on Days 1, 15, and 29.
10785723|NCT03548064|OG004|Outcome|Sublingual 25 µg of dmLT|25 µg of dmLT administered sublingually on Days 1, 15, and 29.
11241036|NCT02484547|FG005|Participant Flow|BIIB037 Early Start: Low Dose (LTE Period)|Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11241037|NCT02484547|FG006|Participant Flow|BIIB037 Early Start: High Dose (LTE Period)|Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
10785724|NCT03548064|OG005|Outcome|Sublingual Placebo|Placebo administered sublingually on Days 1, 15, and 29.
10785725|NCT03548064|OG006|Outcome|Intradermal 0.3 µg of dmLT|0.3 µg of dmLT administered intradermally on Days 1, 22, and 43.
10785726|NCT03548064|OG007|Outcome|Intradermal Placebo|Placebo administered intradermally on Days 1, 22, and 43.
10785727|NCT03548064|EG000|Reported Event|Oral 5 µg dmLT|5 µg of dmLT administered orally on Days 1, 15, and 29.
10785728|NCT03548064|EG001|Reported Event|Oral 25 µg of dmLT|25 µg of dmLT administered orally on Days 1, 15, and 29.
10785729|NCT03548064|EG002|Reported Event|Oral Placebo|Placebo administered orally on Days 1, 15, and 29.
10785730|NCT03548064|EG003|Reported Event|Sublingual 5 µg of dmLT|5 µg of dmLT administered sublingually on Days 1, 15, and 29.
10785731|NCT03548064|EG004|Reported Event|Sublingual 25 µg of dmLT|25 µg of dmLT administered sublingually on Days 1, 15, and 29.
10785732|NCT03548064|EG005|Reported Event|Sublingual Placebo|Placebo administered sublingually on Days 1, 15, and 29.
10785733|NCT03548064|EG006|Reported Event|Intradermal 0.3 µg of dmLT|0.3 µg of dmLT administered intradermally on Days 1, 22, and 43.
10785734|NCT03548064|EG007|Reported Event|Intradermal Placebo|Placebo administered intradermally on Days 1, 22, and 43.
10802101|NCT02851407|FG000|Participant Flow|Defibrotide Prophylaxis|Defibrotide was administered intravenously at a dose of 6.25mg/kg/day in 4 divided doses by IV infusion over 2 hours in addition to best supportive care within 24 hours before the first dose of the conditioning regimen and continued (for those participants without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post-HSCT.
10785735|NCT03446456|BG000|Baseline|Saline|"Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.~Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.~Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785736|NCT03446456|BG001|Baseline|Arginine Vasopressin|"Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.~Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785737|NCT03446456|BG002|Baseline|Total|Total of all reporting groups
10785738|NCT03446456|FG000|Participant Flow|Saline|"Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.~Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.~Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785739|NCT03446456|FG001|Participant Flow|Arginine Vasopressin|"Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.~Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785740|NCT03446456|OG000|Outcome|Saline|"Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.~Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.~Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785741|NCT03446456|OG001|Outcome|Arginine Vasopressin|"Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.~Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785742|NCT03446456|EG000|Reported Event|Saline|"Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.~Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.~Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10802102|NCT02851407|FG001|Participant Flow|Best Supportive Care|Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and participant need, was administered on the first day of conditioning and continued until Day +30 post HSCT or hospital discharge, whichever was sooner, or diagnosis of VOD, if applicable.
10802103|NCT02851407|OG000|Outcome|Defibrotide Prophylaxis|Defibrotide was administered intravenously at a dose of 6.25mg/kg/day in 4 divided doses by IV infusion over 2 hours in addition to best supportive care within 24 hours before the first dose of the conditioning regimen and continued (for those participants without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post-HSCT.
10785743|NCT03446456|EG001|Reported Event|Arginine Vasopressin|"Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.~Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.~Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream."
10785744|NCT03382834|BG000|Baseline|Arm A: Tamoxifen + Vorinostat|"From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Tamoxifen: 20 mg orally~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785745|NCT03382834|BG001|Baseline|Arm B: Vorinostat Alone|"Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785746|NCT03382834|BG002|Baseline|Total|Total of all reporting groups
10785747|NCT03382834|FG000|Participant Flow|Arm A: Tamoxifen + Vorinostat|"From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Tamoxifen: 20 mg orally~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785748|NCT03382834|FG001|Participant Flow|Arm B: Vorinostat Alone|"Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785749|NCT03382834|OG000|Outcome|Arm A: Tamoxifen + Vorinostat|"From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Tamoxifen: 20 mg orally~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785750|NCT03382834|OG001|Outcome|Arm B: Vorinostat Alone|"Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785751|NCT03382834|EG000|Reported Event|Arm A: Tamoxifen + Vorinostat|"From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Tamoxifen: 20 mg orally~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785752|NCT03382834|EG001|Reported Event|Arm B: Vorinostat Alone|"Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.~Vorinostat: 400 mg orally~Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study."
10785753|NCT03371823|BG000|Baseline|Normotensive|"Normotensive PMW will complete an experimental visit to assess vascular function. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visit to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.~Normotensive: FMD is a measure of endothelial function by assessing the degree to which vessel dilates in response to increased flow. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection in all women. Laser Doppler flowmetry is used in combination with cutaneous microdialysis as a minimally invasive technique to examine mechanisms of vascular function. ET-B and ET-A receptor antagonists will be perfused via intradermal microdialysis fibers while measuring cutaneous blood flow. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will also be assessed. Immunohistochemistry will be performed on skin punch biopsy samples to assess for protein expression of ET-A and ET-B receptors."
10964683|NCT00878722|FG004|Participant Flow|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
11194510|NCT02152696|EG001|Reported Event|Uterine Evacuation With MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
11194511|NCT02152696|EG002|Reported Event|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
10785754|NCT03371823|BG001|Baseline|Hypertensives|Hypertensive women will be tested at baseline and then administered Losartan 50 mg once a day at night for 14 days. Vascular function is measured at baseline and again after 2 weeks of losartan. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visits to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.
10785755|NCT03371823|BG002|Baseline|Total|Total of all reporting groups
10785756|NCT03371823|FG000|Participant Flow|Normotensive|"Normotensive postmenopausal women (PMW) will complete an experimental visit to assess vascular function. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visit to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. Endothelin-1 (ET-1) mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.~Normotensive: FMD is a measure of endothelial function by assessing the degree to which vessel dilates in response to increased flow. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection in all women. Laser Doppler flowmetry is used in combination with cutaneous microdialysis as a minimally invasive technique to examine mechanisms of vascular function. ET-B and ET-A receptor antagonists will be perfused via intradermal microdialysis fibers while measuring cutaneous blood flow. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will also be assessed. Immunohistochemistry will be performed on skin punch biopsy samples to assess for protein expression of ET-A and ET-B receptors."
10785757|NCT03371823|FG001|Participant Flow|Hypertensives|Hypertensive women will be tested at baseline and then administered Losartan 50 mg once a day at night for 14 days. Vascular function is measured at baseline and again after 2 weeks of losartan. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visits to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.
10802104|NCT02851407|OG001|Outcome|Best Supportive Care|Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and participant need, was administered on the first day of conditioning and continued until Day +30 post HSCT or hospital discharge, whichever was sooner, or diagnosis of VOD, if applicable.
11194512|NCT02152761|BG000|Baseline|Bimagrumab 700 mg|bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20
11194513|NCT02152761|BG001|Baseline|Bimagrumab 210 mg|bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20
11194514|NCT02152761|BG002|Baseline|Bimagrumab 70 mg|bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20
11194515|NCT02152761|BG003|Baseline|Placebo|placbo administered via intravenous infusion from Day 1 until Week 20
11194516|NCT02152761|BG004|Baseline|Total|Total of all reporting groups
11194517|NCT02152761|FG000|Participant Flow|Bimagrumab 700 mg|bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20
10964684|NCT00878722|FG005|Participant Flow|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10964685|NCT00878722|FG006|Participant Flow|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
11194518|NCT02152761|FG001|Participant Flow|Bimagrumab 210 mg|bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20
11194519|NCT02152761|FG002|Participant Flow|Bimagrumab 70 mg|bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20
11194520|NCT02152761|FG003|Participant Flow|Placebo|placbo administered via intravenous infusion from Day 1 until Week 20
11194521|NCT02152761|OG000|Outcome|Bimagrumab 700 mg|Change from baseline in total LBM
11194522|NCT02152761|OG001|Outcome|Bimagrumab 210 mg|Change from baseline in total LBM
11194523|NCT02152761|OG002|Outcome|Active Total Efficacy (AT:E)|Change from baseline in total LBM
11194524|NCT02152761|OG003|Outcome|Placebo|placebo
11194525|NCT02152761|OG000|Outcome|Bimagrumab 700 mg|bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20
11194526|NCT02152761|OG001|Outcome|Bimagrumab 210 mg|bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20
11194527|NCT02152761|OG002|Outcome|Placebo|placbo administered via intravenous infusion from Day 1 until Week 20
11194528|NCT02152761|OG002|Outcome|Bimagrumab 70mg|bimagrumab 70 mg administered via intravenous infusion from Day 1 until Week 20
11194529|NCT02152761|OG003|Outcome|Placebo|placbo administered via intravenous infusion from Day 1 until Week 20
11194530|NCT02152761|EG000|Reported Event|BYM338 700 mg|bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20
11194531|NCT02152761|EG001|Reported Event|BYM338 210 mg|bimagrumab 210mg administered via intravenous infusion from Day 1 until Week 20
11194532|NCT02152761|EG002|Reported Event|BYM338 70 mg|bimagrumab 70 mg via i.v. infusion
11194533|NCT02152761|EG003|Reported Event|AT:S|Active Total Safety
11194534|NCT02152761|EG004|Reported Event|Placebo|placebo administered via intravenous infusion from Day 1 until Week 20
11194535|NCT02152826|BG000|Baseline|Potassium Oxalate Gel|"Professional application~Potassium oxalate: Professional application"
11194536|NCT02152826|BG001|Baseline|Potassium Oxalate Liquid|"Professional application~Potassium oxalate: Professional application"
11194537|NCT02152826|BG002|Baseline|Total|Total of all reporting groups
10785758|NCT03371823|OG000|Outcome|Normotensive|"Normotensive PMW will complete an experimental visit to assess vascular function. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visit to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.~Normotensive: FMD is a measure of endothelial function by assessing the degree to which vessel dilates in response to increased flow. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection in all women. Laser Doppler flowmetry is used in combination with cutaneous microdialysis as a minimally invasive technique to examine mechanisms of vascular function. ET-B and ET-A receptor antagonists will be perfused via intradermal microdialysis fibers while measuring cutaneous blood flow. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will also be assessed. Immunohistochemistry will be performed on skin punch biopsy samples to assess for protein expression of ET-A and ET-B receptors."
10785759|NCT03371823|OG001|Outcome|Hypertensives|Hypertensive women will be tested at baseline and then administered Losartan 50 mg once a day at night for 14 days. Vascular function is measured at baseline and again after 2 weeks of losartan. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visits to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.
10785760|NCT03371823|EG000|Reported Event|Normotensive|"Normotensive PMW will complete an experimental visit to assess vascular function. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visit to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.~Normotensive: FMD is a measure of endothelial function by assessing the degree to which vessel dilates in response to increased flow. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection in all women. Laser Doppler flowmetry is used in combination with cutaneous microdialysis as a minimally invasive technique to examine mechanisms of vascular function. ET-B and ET-A receptor antagonists will be perfused via intradermal microdialysis fibers while measuring cutaneous blood flow. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will also be assessed. Immunohistochemistry will be performed on skin punch biopsy samples to assess for protein expression of ET-A and ET-B receptors."
10785761|NCT03371823|EG001|Reported Event|Hypertensives|Hypertensive women will be tested at baseline and then administered Losartan 50 mg once a day at night for 14 days. Vascular function is measured at baseline and again after 2 weeks of losartan. All women will wear an ambulatory BP monitor during the 24 hours preceding the experimental visits to confirm BP classification. Large blood vessel function will be assessed using two non-invasive techniques: 1. Flow Mediated Dilation (FMD) 2. Pulse Wave Analysis and Pulse Wave Velocity. ET-1 mediated vasoconstrictor tone is assessed by measuring the cutaneous blood flow during microdialysis perfusions of ET-A and ET-B receptor antagonist. ET-1 production, ET-A and ET-B receptor expression is assessed from antecubital vein endothelial cells and skin punch biopsy samples.
10785762|NCT03353350|BG000|Baseline|Placebo|"Matching placebo (Prefilled syringe) administered once weekly for 56 weeks~placebo: Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785763|NCT03353350|BG001|Baseline|Efpeglenatide 2 mg|"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785764|NCT03353350|BG002|Baseline|Efpeglenatide 4 mg|"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785765|NCT03353350|BG003|Baseline|Efpeglenatide 6 mg|"Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785766|NCT03353350|BG004|Baseline|Total|Total of all reporting groups
10964686|NCT00878722|FG007|Participant Flow|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
11194538|NCT02152826|FG000|Participant Flow|Potassium Oxalate Gel|"Professional application~Potassium oxalate: Professional application"
10785767|NCT03353350|FG000|Participant Flow|Placebo|"Matching placebo (Prefilled syringe) administered once weekly for 56 weeks~placebo: Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785768|NCT03353350|FG001|Participant Flow|Efpeglenatide 2 mg|"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10964687|NCT00878722|OG000|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
10964688|NCT00878722|OG001|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
10964689|NCT00878722|OG002|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
10964690|NCT00878722|OG003|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
10964691|NCT00878722|OG004|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
11194539|NCT02152826|FG001|Participant Flow|Potassium Oxalate Liquid|"Professional application~Potassium oxalate: Professional application"
10785769|NCT03353350|FG002|Participant Flow|Efpeglenatide 4 mg|"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785770|NCT03353350|FG003|Participant Flow|Efpeglenatide 6 mg|"Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785771|NCT03353350|OG000|Outcome|Placebo|"Matching placebo (Prefilled syringe) administered once weekly for 56 weeks~placebo: Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785772|NCT03353350|OG001|Outcome|Efpeglenatide 2 mg|"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785773|NCT03353350|OG002|Outcome|Efpeglenatide 4 mg|"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785774|NCT03353350|OG003|Outcome|Efpeglenatide 6 mg|"Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785775|NCT03353350|EG000|Reported Event|Placebo|"Matching placebo (Prefilled syringe) administered once weekly for 56 weeks~placebo: Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785776|NCT03353350|EG001|Reported Event|Efpeglenatide 2 mg|"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785777|NCT03353350|EG002|Reported Event|Efpeglenatide 4 mg|"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785778|NCT03353350|EG003|Reported Event|Efpeglenatide 6 mg|"Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)~efpeglenatide (SAR439977): Pharmaceutical form: solution for injection~Route of administration: subcutaneous"
10785779|NCT03350503|BG000|Baseline|Acrysof IQ Toric A-code IOL|AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
10785780|NCT03350503|FG000|Participant Flow|AcrySof IQ Toric A-code IOL|AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
10785781|NCT03350503|OG000|Outcome|Acrysof IQ Toric A-code IOL|AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
10785782|NCT03350503|EG000|Reported Event|Acrysof IQ Toric A-code IOL|AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
10785783|NCT03326193|BG000|Baseline|Niraparib + Bevacizumab|Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
10785784|NCT03326193|FG000|Participant Flow|Niraparib + Bevacizumab|Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
10785785|NCT03326193|OG000|Outcome|Niraparib + Bevacizumab|Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
10785786|NCT03326193|EG000|Reported Event|Niraparib + Bevacizumab|Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
10785787|NCT03287687|BG000|Baseline|Air for Insufflation|"In this arm of patients, air which is currently used as standard of care will be used for insufflation~Air: Air is the standard of practice and will be used in the control arm"
10785788|NCT03287687|BG001|Baseline|Carbon Dioxide Gas for Insufflation|"in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy~Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air"
10785789|NCT03287687|BG002|Baseline|Total|Total of all reporting groups
10785790|NCT03287687|FG000|Participant Flow|Air for Insufflation|"In this arm of patients, air which is currently used as standard of care will be used for insufflation~Air: Air is the standard of practice and will be used in the control arm"
11194540|NCT02152826|OG000|Outcome|Potassium Oxalate Gel|"Professional application~Potassium oxalate: Professional application"
10785791|NCT03287687|FG001|Participant Flow|Carbon Dioxide Gas for Insufflation|"in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy~Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air"
10785792|NCT03287687|OG000|Outcome|Air for Insufflation|"In this arm of patients, air which is currently used as standard of care will be used for insufflation~Air: Air is the standard of practice and will be used in the control arm"
10785793|NCT03287687|OG001|Outcome|Carbon Dioxide Gas for Insufflation|"in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy~Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air"
10785794|NCT03287687|EG000|Reported Event|Air for Insufflation|"In this arm of patients, air which is currently used as standard of care will be used for insufflation~Air: Air is the standard of practice and will be used in the control arm"
11194541|NCT02152826|OG001|Outcome|Potassium Oxalate Liquid|"Professional application~Potassium oxalate: Professional application"
11194542|NCT02152826|EG000|Reported Event|Potassium Oxalate Gel|"Professional application~Potassium oxalate: Professional application"
11194543|NCT02152826|EG001|Reported Event|Potassium Oxalate Liquid|"Professional application~Potassium oxalate: Professional application"
10785795|NCT03287687|EG001|Reported Event|Carbon Dioxide Gas for Insufflation|"in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy~Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air"
10785796|NCT03282565|BG000|Baseline|Functional Resistance Training With Brace|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill."
10785797|NCT03282565|BG001|Baseline|Functional Resistance Training With Elastic Band|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill."
10785798|NCT03282565|BG002|Baseline|Control|"Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.~Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill."
10785799|NCT03282565|BG003|Baseline|Total|Total of all reporting groups
10785800|NCT03282565|FG000|Participant Flow|Functional Resistance Training With Brace|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill."
10785801|NCT03282565|FG001|Participant Flow|Functional Resistance Training With Elastic Band|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill."
10785802|NCT03282565|FG002|Participant Flow|Control|"Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.~Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill."
10785803|NCT03282565|OG000|Outcome|Functional Resistance Training With Brace|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill."
10785804|NCT03282565|OG001|Outcome|Functional Resistance Training With Elastic Band|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill."
10785805|NCT03282565|OG002|Outcome|Control|"Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.~Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill."
10785806|NCT03282565|EG000|Reported Event|Functional Resistance Training With Brace|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: A customized knee brace was strapped to the leg and applied resistance during knee flexion and extension while subjects walked on a treadmill."
10785807|NCT03282565|EG001|Reported Event|Functional Resistance Training With Elastic Band|"Participants received functional resistance training while walking on a treadmill 2-3 times a week for 8 weeks.~Functional Resistance Training: An elastic band strapped to the ankle provided resistance during knee extension while subjects walked on a treadmill."
11194544|NCT02153073|BG000|Baseline|Omega-3 Fatty Acid Ethyl Esters 2 g|Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care.
10964692|NCT00878722|OG005|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10785808|NCT03282565|EG002|Reported Event|Control|"Participants walked on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.~Control: A knee brace was strapped to the leg and did not apply resistance while subjects walked on a treadmill."
10802105|NCT02851407|EG000|Reported Event|Defibrotide Prophylaxis|Defibrotide was administered intravenously at a dose of 6.25mg/kg/day in 4 divided doses by IV infusion over 2 hours in addition to best supportive care within 24 hours before the first dose of the conditioning regimen and continued (for those participants without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post-HSCT.
10802106|NCT02851407|EG001|Reported Event|Best Supportive Care|Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and participant need, was administered on the first day of conditioning and continued until Day +30 post HSCT or hospital discharge, whichever was sooner, or diagnosis of VOD, if applicable.
10802107|NCT02707276|BG000|Baseline|Phase 1: Cross-Over, Active LFMS First|"Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10803759|NCT02134028|OG000|Outcome|Participants From DRI12544: Placebo/Dupilumab|Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11194545|NCT02153073|FG000|Participant Flow|Omega-3 Fatty Acid Ethyl Esters 2 g|Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care.
10785809|NCT03276936|BG000|Baseline|DB-FMX103 1.5% Minocycline Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785810|NCT03276936|BG001|Baseline|DB-Vehicle Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785811|NCT03276936|BG002|Baseline|Total|Total of all reporting groups
10785812|NCT03276936|FG000|Participant Flow|DB-FMX103 1.5% Minocycline Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785813|NCT03276936|FG001|Participant Flow|DB-Vehicle Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785814|NCT03276936|OG000|Outcome|DB-FMX103 1.5% Minocycline Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785815|NCT03276936|OG001|Outcome|DB-Vehicle Foam|Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
10785816|NCT03276936|EG000|Reported Event|Minocycline Foam 1.5%|Participants applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks.
10785817|NCT03276936|EG001|Reported Event|Vehicle Foam|Participants applied matching vehicle foam topically to the face once daily for 40 weeks.
10785818|NCT03271021|BG000|Baseline|FMX101, 4% Minocycline Foam|"FMX101, 4% minocycline foam applied topically once daily for 12 weeks~FMX101: FMX101, 4% minocycline foam"
10785819|NCT03271021|BG001|Baseline|Vehicle Foam|"Vehicle foam applied topically once daily for 12 weeks~Vehicle Foam: Vehicle Foam"
10785820|NCT03271021|BG002|Baseline|Total|Total of all reporting groups
10785821|NCT03271021|FG000|Participant Flow|FMX101, 4% Minocycline Foam|"FMX101, 4% minocycline foam applied topically once daily for 12 weeks~FMX101: FMX101, 4% minocycline foam"
10785822|NCT03271021|FG001|Participant Flow|Vehicle Foam|"Vehicle foam applied topically once daily for 12 weeks~Vehicle Foam: Vehicle Foam"
10785823|NCT03271021|OG000|Outcome|FMX101, 4% Minocycline Foam|"FMX101, 4% minocycline foam applied topically once daily for 12 weeks~FMX101: FMX101, 4% minocycline foam"
10785824|NCT03271021|OG001|Outcome|Vehicle Foam|"Vehicle foam applied topically once daily for 12 weeks~Vehicle Foam: Vehicle Foam"
10785825|NCT03271021|EG000|Reported Event|FMX101, 4% Minocycline Foam|"FMX101, 4% minocycline foam applied topically once daily for 12 weeks~FMX101: FMX101, 4% minocycline foam"
10785826|NCT03271021|EG001|Reported Event|Vehicle Foam|"Vehicle foam applied topically once daily for 12 weeks~Vehicle Foam: Vehicle Foam"
10964693|NCT00878722|OG006|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10785827|NCT03255083|BG000|Baseline|DS-1205c 200 mg + Osimertinib|Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785828|NCT03255083|BG001|Baseline|DS-1205c 400 mg + Osimertinib|Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785829|NCT03255083|BG002|Baseline|DS-1205c 800 mg + Osimertinib|Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785830|NCT03255083|BG003|Baseline|DS-1205c 1200 mg + Osimertinib|Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785831|NCT03255083|BG004|Baseline|Total|Total of all reporting groups
10785832|NCT03255083|FG000|Participant Flow|DS-1205c 200 mg + Osimertinib|Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785833|NCT03255083|FG001|Participant Flow|DS-1205c 400 mg + Osimertinib|Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785834|NCT03255083|FG002|Participant Flow|DS-1205c 800 mg + Osimertinib|Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785835|NCT03255083|FG003|Participant Flow|DS-1205c 1200 mg + Osimertinib|Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785836|NCT03255083|OG000|Outcome|DS-1205c 200 mg + Osimertinib|Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785837|NCT03255083|OG001|Outcome|DS-1205c 400 mg + Osimertinib|Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785838|NCT03255083|OG002|Outcome|DS-1205c 800 mg + Osimertinib|Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785839|NCT03255083|OG003|Outcome|DS-1205c 1200 mg + Osimertinib|Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785840|NCT03255083|EG000|Reported Event|DS-1205c 200 mg + Osimertinib|Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785841|NCT03255083|EG001|Reported Event|DS-1205c 400 mg + Osimertinib|Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785842|NCT03255083|EG002|Reported Event|DS-1205c 800 mg + Osimertinib|Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785843|NCT03255083|EG003|Reported Event|DS-1205c 1200 mg + Osimertinib|Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
10785844|NCT03227471|BG000|Baseline|Part A: Pooled Placebo (Except Cohort A7)|Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
10785845|NCT03227471|BG001|Baseline|Part A: VX-445 (Except Cohort A7)|Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
10785846|NCT03227471|BG002|Baseline|Part A: VX-445 (Cohort A7)|Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.
10785847|NCT03227471|BG003|Baseline|Part B: Pooled Placebo (Cohort B1 to B4)|Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
10785848|NCT03227471|BG004|Baseline|Part B: VX-445 (Cohort B1 to B4)|Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
10785849|NCT03227471|BG005|Baseline|Part C: Pooled Placebo (Cohort C1 to C3)|Participants without CF who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 14 days.
10785850|NCT03227471|BG006|Baseline|Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)|Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
10785851|NCT03227471|BG007|Baseline|Part D: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
10785852|NCT03227471|BG008|Baseline|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785853|NCT03227471|BG009|Baseline|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785854|NCT03227471|BG010|Baseline|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785855|NCT03227471|BG011|Baseline|Part E: TEZ/IVA|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
10785856|NCT03227471|BG012|Baseline|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785857|NCT03227471|BG013|Baseline|Part F: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
10785858|NCT03227471|BG014|Baseline|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785859|NCT03227471|BG015|Baseline|Total|Total of all reporting groups
10785860|NCT03227471|FG000|Participant Flow|Part A: Pooled Placebo (Except Cohort A7)|Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
10785861|NCT03227471|FG001|Participant Flow|Part A: VX-445 (Except Cohort A7)|Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
10785862|NCT03227471|FG002|Participant Flow|Part A: VX-445 (Cohort A7)|Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
10785863|NCT03227471|FG003|Participant Flow|Part B: Pooled Placebo (Cohort B1 to B4)|Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
10785864|NCT03227471|FG004|Participant Flow|Part B: VX-445 (Cohort B1 to B4)|Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
10785865|NCT03227471|FG005|Participant Flow|Part C: Pooled Placebo (Cohort C1 to C3)|Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
10785866|NCT03227471|FG006|Participant Flow|Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)|Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
10785867|NCT03227471|FG007|Participant Flow|Part D: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
10785868|NCT03227471|FG008|Participant Flow|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785869|NCT03227471|FG009|Participant Flow|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785870|NCT03227471|FG010|Participant Flow|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785871|NCT03227471|FG011|Participant Flow|Part E: TEZ/IVA|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
10785872|NCT03227471|FG012|Participant Flow|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785873|NCT03227471|FG013|Participant Flow|Part F: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
10785874|NCT03227471|FG014|Participant Flow|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785875|NCT03227471|OG000|Outcome|Part A: Pooled Placebo (Except Cohort A7)|Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
10785876|NCT03227471|OG001|Outcome|Part A: VX-445 (Except Cohort A7)|Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
10785877|NCT03227471|OG002|Outcome|Part A: VX-445 (Cohort A7)|Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
10785878|NCT03227471|OG003|Outcome|Part B: Pooled Placebo (Cohort B1 to B4)|Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
10785879|NCT03227471|OG004|Outcome|Part B: VX-445 (Cohort B1 to B4)|Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
10785880|NCT03227471|OG005|Outcome|Part C: Pooled Placebo (Cohort C1 to C3)|Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
10785881|NCT03227471|OG006|Outcome|Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)|Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
10785882|NCT03227471|OG000|Outcome|Part D: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
10785883|NCT03227471|OG001|Outcome|Part D: VX-445/TEZ/IVA TC|Participants with CF, F/MF genotype who received VX-445/TEZ/IVA TC for 4 weeks in the TC treatment period.
10785884|NCT03227471|OG002|Outcome|Part E: TEZ/IVA|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
11194546|NCT02153073|OG000|Outcome|Omega-3 Fatty Acid Ethyl Esters 2 g|Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care.
10785885|NCT03227471|OG003|Outcome|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785886|NCT03227471|OG004|Outcome|Part F: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
10785887|NCT03227471|OG005|Outcome|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785888|NCT03227471|OG001|Outcome|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785889|NCT03227471|OG002|Outcome|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785890|NCT03227471|OG003|Outcome|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785891|NCT03227471|OG000|Outcome|Part E: TEZ/IVA|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
10785892|NCT03227471|OG001|Outcome|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785893|NCT03227471|OG000|Outcome|Part F: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
10785894|NCT03227471|OG001|Outcome|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg/TEZ 100 mg/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785895|NCT03227471|OG000|Outcome|Part A: VX-445 (Cohort A1)|Participants received single dose of VX-445 20 mg tablet in Cohort A1.
10785896|NCT03227471|OG001|Outcome|Part A: VX-445 (Cohort A2)|Participants received single dose of VX-445 60 mg tablet in Cohort A2.
10785897|NCT03227471|OG002|Outcome|Part A: VX-445 (Cohort A3)|Participants received single dose of VX-445 120 mg tablet in Cohort A3.
10785898|NCT03227471|OG003|Outcome|Part A: VX-445 (Cohort A4)|Participants received single dose of VX-445 240 mg tablet in Cohort A4.
10785899|NCT03227471|OG004|Outcome|Part A: VX-445 (Cohort A5)|Participants received single dose of VX-445 360 mg tablet in Cohort A5.
10785900|NCT03227471|OG005|Outcome|Part A: VX-445 (Cohort A7-Fasted)|Participants received single dose of VX-445 100 mg tablet on Day 1 in fasted state in Cohort A7.
10785901|NCT03227471|OG006|Outcome|Part A: VX-445 (Cohort A7-Fed)|Participants received single dose of VX-445 100 mg tablet on Day 7 in fed state in Cohort A7.
10785902|NCT03227471|OG007|Outcome|Part A: VX-445 (Cohort A7-IV)|Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
10785903|NCT03227471|OG000|Outcome|Part B: VX-445 (Cohort B1)|Participants received VX-445 60 mg tablet once daily for 10 days in Cohort B1.
10785904|NCT03227471|OG001|Outcome|Part B: VX-445 (Cohort B2)|Participants received VX-445 120 mg tablet once daily for 10 days in Cohort B2.
10785905|NCT03227471|OG002|Outcome|Part B: VX-445 (Cohort B3)|Participants received VX-445 240 mg tablet once daily for 10 days in Cohort B3.
10785906|NCT03227471|OG003|Outcome|Part B: VX-445 (Cohort B4)|Participants received VX-445 340 mg tablet once daily for 10 days in Cohort B4.
10785907|NCT03227471|OG000|Outcome|Part C: VX-445/TEZ/IVA TC (Cohort C1)|Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.
10785908|NCT03227471|OG001|Outcome|Part C: VX-445/TEZ/IVA TC (Cohort C2)|Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.
11194547|NCT02153073|EG000|Reported Event|Omega-3 Fatty Acid Ethyl Esters 2 g|Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care.
10785909|NCT03227471|OG002|Outcome|Part C: VX-445/TEZ/IVA TC (Cohort C3)|Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.
10785910|NCT03227471|OG000|Outcome|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785911|NCT03227471|OG001|Outcome|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785912|NCT03227471|OG002|Outcome|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785913|NCT03227471|OG000|Outcome|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785914|NCT03227471|OG001|Outcome|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785915|NCT03227471|OG001|Outcome|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785916|NCT03227471|OG002|Outcome|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785917|NCT03227471|OG003|Outcome|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785918|NCT03227471|OG001|Outcome|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785919|NCT03227471|EG000|Reported Event|Part A: Pooled Placebo (Except Cohort A7)|Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
10785920|NCT03227471|EG001|Reported Event|Part A: VX-445 (Except Cohort A7)|Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
10785921|NCT03227471|EG002|Reported Event|Part A: VX-445 (Cohort A7)|Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.
10785922|NCT03227471|EG003|Reported Event|Part B: Pooled Placebo (Cohort B1 to B4)|Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
10785923|NCT03227471|EG004|Reported Event|Part B: VX-445 (Cohort B1 to B4)|Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
10785924|NCT03227471|EG005|Reported Event|Part C: Pooled Placebo (Cohort C1 to C3)|Participants without CF who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 14 days.
10785925|NCT03227471|EG006|Reported Event|Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)|Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
10785926|NCT03227471|EG007|Reported Event|Part D: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
10785927|NCT03227471|EG008|Reported Event|Part D: VX-445/TEZ/IVA TC - Low Dose|Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
11194548|NCT02153086|BG000|Baseline|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
10785928|NCT03227471|EG009|Reported Event|Part D: VX-445/TEZ/IVA TC - Medium Dose|Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785929|NCT03227471|EG010|Reported Event|Part D: VX-445/TEZ/IVA TC - High Dose|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
10785930|NCT03227471|EG011|Reported Event|Part E: TEZ/IVA|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
11194549|NCT02153086|FG000|Participant Flow|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
11382039|NCT02500797|OG003|Outcome|LPS Dual|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382040|NCT02500797|OG004|Outcome|UPS/MFH Single|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382041|NCT02500797|OG005|Outcome|UPS/MFH Dual|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382042|NCT02500797|OG006|Outcome|GIST Single|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382043|NCT02500797|OG007|Outcome|GIST Dual|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382044|NCT02500797|OG000|Outcome|Initial Single|Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
11382045|NCT02500797|OG000|Outcome|LPS Single|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11194550|NCT02153086|OG000|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
11382046|NCT02500797|OG001|Outcome|LPS Dual|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382047|NCT02500797|OG002|Outcome|UPS/MFH Single|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382048|NCT02500797|OG003|Outcome|UPS/MFH Dual|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382049|NCT02500797|OG000|Outcome|GIST Single|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382050|NCT02500797|OG001|Outcome|GIST Dual|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382051|NCT02500797|EG000|Reported Event|Initial Single|Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382052|NCT02500797|EG001|Reported Event|Initial Dual|Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382053|NCT02500797|EG002|Reported Event|LPS Single|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382054|NCT02500797|EG003|Reported Event|LPS Dual|Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382055|NCT02500797|EG004|Reported Event|UPS/MFH Single|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382056|NCT02500797|EG005|Reported Event|UPS/MFH Dual|Undifferentiated Pleomorphic Sarcoma & Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382057|NCT02500797|EG006|Reported Event|GIST Single|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
11382058|NCT02500797|EG007|Reported Event|GIST Dual|Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
11382059|NCT02447133|BG000|Baseline|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
11382060|NCT02447133|FG000|Participant Flow|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
11382061|NCT02447133|OG000|Outcome|12x9 Wide Scan|TopQ of 12x9 Wide Scan
11382062|NCT02447133|OG001|Outcome|6x6 Macula Scan|TopQ of 6x6 Macular Scan
11382063|NCT02447133|OG002|Outcome|6x6 Disc Scan|TopQ of 6x6 Disc Scan
11382064|NCT02447133|EG000|Reported Event|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
11382065|NCT02446600|BG000|Baseline|Arm I (Platinum-based Chemotherapy)|REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
11382066|NCT02446600|BG001|Baseline|Arm II (Olaparib)|Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382067|NCT02446600|BG002|Baseline|Arm III (Olaparib, Cediranib Maleate)|Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382068|NCT02446600|BG003|Baseline|Japanese Cohort|A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
11382069|NCT02446600|BG004|Baseline|Total|Total of all reporting groups
11382070|NCT02446600|FG000|Participant Flow|Arm I (Platinum-based Chemotherapy)|REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
11382071|NCT02446600|FG001|Participant Flow|Arm II (Olaparib)|Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382072|NCT02446600|FG002|Participant Flow|Arm III (Olaparib, Cediranib Maleate)|Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382073|NCT02446600|FG003|Participant Flow|Japanese Cohort|A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
11382074|NCT02446600|OG000|Outcome|Arm I (Platinum-based Chemotherapy)|REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
11382075|NCT02446600|OG001|Outcome|Arm II (Olaparib)|Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382076|NCT02446600|OG002|Outcome|Arm III (Olaparib, Cediranib Maleate)|Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382077|NCT02446600|OG003|Outcome|Japanese Cohort|A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
11382078|NCT02446600|EG000|Reported Event|Arm I (Platinum-based Chemotherapy)|REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
11382079|NCT02446600|EG001|Reported Event|Arm II (Olaparib)|Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382080|NCT02446600|EG002|Reported Event|Arm III (Olaparib, Cediranib Maleate)|Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382081|NCT02446600|EG003|Reported Event|Japanese Cohort|A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
11382082|NCT02426658|BG000|Baseline|Treatment (Pemetrexed Disodium)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV~Quality-of-Life Assessment: QOL studies"
11382083|NCT02426658|FG000|Participant Flow|Treatment (Pemetrexed Disodium)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV~Quality-of-Life Assessment: QOL studies"
10785931|NCT03227471|EG012|Reported Event|Part E: VX-445/TEZ/IVA TC|Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
11382084|NCT02426658|OG000|Outcome|Treatment (Pemetrexed Disodium)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV~Quality-of-Life Assessment: QOL studies"
11382085|NCT02426658|EG000|Reported Event|Treatment (Pemetrexed Disodium)|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV~Quality-of-Life Assessment: QOL studies"
11382086|NCT02281084|BG000|Baseline|Progressive Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382087|NCT02281084|BG001|Baseline|Progressive Disease (PD) Cohort: Oral Azacitidine|Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382088|NCT02281084|BG002|Baseline|Stable Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382089|NCT02281084|BG003|Baseline|Stable Disease (SD) Cohort: Oral Azacitidine|Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382090|NCT02281084|BG004|Baseline|Total|Total of all reporting groups
11382091|NCT02281084|FG000|Participant Flow|Stable Disease (SD) Cohort: Oral Azacitidine|Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382092|NCT02281084|FG001|Participant Flow|Progressive Disease (PD) Cohort: Oral Azacitidine|Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382093|NCT02281084|FG002|Participant Flow|Stable Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382094|NCT02281084|FG003|Participant Flow|Progressive Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382095|NCT02281084|OG000|Outcome|Stable Disease (SD) Cohort: Oral Azacitidine|Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382096|NCT02281084|OG001|Outcome|Progressive Disease (PD) Cohort: Oral Azacitidine|Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382097|NCT02281084|OG002|Outcome|Stable Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382098|NCT02281084|OG003|Outcome|Progressive Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382099|NCT02281084|EG000|Reported Event|Stable Disease (SD) Cohort: Oral Azacitidine|Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382100|NCT02281084|EG001|Reported Event|Progressive Disease (PD) Cohort: Oral Azacitidine|Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11194551|NCT02153086|EG000|Reported Event|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
11382101|NCT02281084|EG002|Reported Event|Stable Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382102|NCT02281084|EG003|Reported Event|Progressive Disease Cohort: Oral Azacitidine and Durvalumab|Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
11382103|NCT02277106|BG000|Baseline|Stage 1 (Double-blind): SAGE-547 and Placebo|Participants who received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE-547 matched-placebo, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days. Participants who received a 12-hour IV infusion of SAGE-547 matched-placebo on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days.
11382104|NCT02277106|FG000|Participant Flow|Stage 1 (Double-blind): SAGE 547, Then Placebo|Participants received a 12-hour intravenous (IV) infusion of SAGE 547, at ascending doses of 29, 58, and 86 micrograms per kilogram of body weight per hour (μg/kg/h), 4 hours each, on Day 1 of Stage 1 [Treatment Period 1 (TP 1)]. After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE-547 matching-placebo, on Day 10 of Stage 1 [Treatment Period 2 (TP 2)].
11382105|NCT02277106|FG001|Participant Flow|Stage 1 (Double-blind): Placebo, Then SAGE-547|Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1). After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2).
11382106|NCT02277106|FG002|Participant Flow|Stage 2 (Open Label): SAGE-547|Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
11382107|NCT02277106|OG000|Outcome|Stage 1: SAGE-547|Participants received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2).
11382108|NCT02277106|OG001|Outcome|Stage 1: Placebo|Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2).
11382109|NCT02277106|OG000|Outcome|Stage 2: SAGE-547|Participants who completed Stage 1 received a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
11382110|NCT02277106|OG001|Outcome|Stage 1: Placebo|Participants received one 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2).
11382111|NCT02277106|OG000|Outcome|Stage 2: SAGE-547|Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
11382112|NCT02277106|OG000|Outcome|Stage 2: SAGE-547|Participants who completed Stage 1 received one 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
11382113|NCT02277106|EG000|Reported Event|Stage 1: SAGE-547|Participants received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2).
11382114|NCT02277106|EG001|Reported Event|Stage 1: Placebo|Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2).
11382115|NCT02277106|EG002|Reported Event|Stage 2: SAGE-547|Participants who completed Stage 1 received a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
11382116|NCT02175030|BG000|Baseline|Copper T380 IUD|"Randomized to copper T380 IUD for EC (emergency contraception)~Copper IUD: Randomization to copper/Paragard IUD for emergency contraception"
11382117|NCT02175030|BG001|Baseline|LNG20 IUD|"Randomized to LNG20 IUD for EC (emergency contraception)~Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception"
11382118|NCT02175030|BG002|Baseline|Total|Total of all reporting groups
11382119|NCT02175030|FG000|Participant Flow|Copper T380 IUD|"Randomized to copper T380 IUD for EC (emergency contraception)~Copper IUD: Randomization to copper/Paragard IUD for emergency contraception"
11382120|NCT02175030|FG001|Participant Flow|LNG20 IUD|"Randomized to LNG20 IUD for EC (emergency contraception)~Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception"
11382121|NCT02175030|OG000|Outcome|Copper T380 IUD|"Randomized to copper T380 IUD for EC (emergency contraception)~Copper IUD: Randomization to copper/Paragard IUD for emergency contraception"
11382122|NCT02175030|OG001|Outcome|LNG20 IUD|"Randomized to LNG20 IUD for EC (emergency contraception)~Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception"
11382123|NCT02175030|EG000|Reported Event|Copper T380 IUD|"Randomized to copper T380 IUD for EC (emergency contraception)~Copper IUD: Randomization to copper/Paragard IUD for emergency contraception"
11382124|NCT02175030|EG001|Reported Event|LNG20 IUD|"Randomized to LNG20 IUD for EC (emergency contraception)~Levonorgestrel IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception"
11382125|NCT02059265|BG000|Baseline|Dasatinib|Dasatinib - 140 mg by mouth, once daily, on days 1-28 (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy
11382126|NCT02059265|FG000|Participant Flow|Treatment (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
10785932|NCT03227471|EG013|Reported Event|Part F: Placebo|Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
10785933|NCT03227471|EG014|Reported Event|Part F: VX-445/TEZ/VX-561 TC|Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
10785934|NCT03221842|BG000|Baseline|C1-INH|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785935|NCT03221842|FG000|Participant Flow|C1-INH|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785936|NCT03221842|FG001|Participant Flow|Placebo|"Excipients of C1-INH plus albumin~Placebo: Excipients of C1-INH plus albumin"
10785937|NCT03221842|OG000|Outcome|C1-INH|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785938|NCT03221842|OG001|Outcome|Placebo|"Excipients of C1-INH plus albumin~Placebo: Excipients of C1-INH plus albumin"
10785939|NCT03221842|OG000|Outcome|C1-INH (Period 1)|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
11194552|NCT02153099|BG000|Baseline|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
11194553|NCT02153099|BG001|Baseline|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
11194554|NCT02153099|BG002|Baseline|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
11194555|NCT02153099|BG003|Baseline|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
10785940|NCT03221842|OG001|Outcome|C1-INH (Period 2)|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785941|NCT03221842|OG002|Outcome|Placebo|"Excipients of C1-INH plus albumin~Placebo: Excipients of C1-INH plus albumin"
10785942|NCT03221842|EG000|Reported Event|C1-INH (Period 1)|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785943|NCT03221842|EG001|Reported Event|C1-INH (Period 2)|"C1-esterase inhibitor (CSL842)~C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg"
10785944|NCT03221842|EG002|Reported Event|Placebo (Period 2)|"Excipients of C1-INH plus albumin~Placebo: Excipients of C1-INH plus albumin"
11194556|NCT02153099|BG004|Baseline|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
11194557|NCT02153099|BG005|Baseline|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
11194558|NCT02153099|BG006|Baseline|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
11194559|NCT02153099|BG007|Baseline|Total|Total of all reporting groups
11194560|NCT02153099|FG000|Participant Flow|Cohort 4: TAK-058 5 mg|TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1.
11194561|NCT02153099|FG001|Participant Flow|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
10785945|NCT03194321|BG000|Baseline|Tacrolimus Extended-Release Arm|"All patients will receive tacrolimus extended-release adjusted to target trough levels, mycophenolate mofetil or mycophenolate sodium, and prednisone per CSMC practice.~Tacrolimus Extended-Release Oral Capsule: Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone."
10785946|NCT03194321|FG000|Participant Flow|Tacrolimus Extended-Release Arm|"All patients will receive tacrolimus extended-release adjusted to target trough levels, mycophenolate mofetil or mycophenolate sodium, and prednisone per CSMC practice.~Tacrolimus Extended-Release Oral Capsule: Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone."
10785947|NCT03194321|OG000|Outcome|Tacrolimus Extended-Release Arm|"All patients will receive tacrolimus extended-release adjusted to target trough levels, mycophenolate mofetil or mycophenolate sodium, and prednisone per CSMC practice.~Tacrolimus Extended-Release Oral Capsule: Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone."
10785948|NCT03194321|EG000|Reported Event|Tacrolimus Extended-Release Arm|"All patients will receive tacrolimus extended-release adjusted to target trough levels, mycophenolate mofetil or mycophenolate sodium, and prednisone per CSMC practice.~Tacrolimus Extended-Release Oral Capsule: Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone."
10785949|NCT03085095|BG000|Baseline|Relugolix|Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785950|NCT03085095|BG001|Baseline|Leuprolide Acetate|Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
10785951|NCT03085095|BG002|Baseline|Total|Total of all reporting groups
10785952|NCT03085095|FG000|Participant Flow|Relugolix|Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
11194562|NCT02153099|FG002|Participant Flow|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
11194563|NCT02153099|FG003|Participant Flow|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
11194564|NCT02153099|FG004|Participant Flow|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
11194565|NCT02153099|FG005|Participant Flow|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
11194566|NCT02153099|FG006|Participant Flow|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
11194567|NCT02153099|OG000|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
11194568|NCT02153099|OG001|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
11194569|NCT02153099|OG002|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
10785953|NCT03085095|FG001|Participant Flow|Leuprolide Acetate|Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
10785954|NCT03085095|OG000|Outcome|Relugolix|Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785955|NCT03085095|OG001|Outcome|Leuprolide Acetate|Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
10785956|NCT03085095|OG000|Outcome|Relugolix|Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785957|NCT03085095|OG000|Outcome|Relugolix Single-Dose|Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785958|NCT03085095|OG001|Outcome|Relugolix Repeat-Dose|Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785959|NCT03085095|EG000|Reported Event|Relugolix|Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
10785960|NCT03085095|EG001|Reported Event|Leuprolide Acetate|Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.
10785961|NCT03048422|BG000|Baseline|Arm 1: Maternal DTG+FTC/TAF|Mothers randomized to receive DTG+FTC/TAF
10785962|NCT03048422|BG001|Baseline|Arm 2: Maternal DTG+FTC/TDF|Mothers randomized to receive DTG+FTC/TDF
10785963|NCT03048422|BG002|Baseline|Arm 3: Maternal EFV/FTC/TDF|Mothers randomized to receive EFV/FTC/TDF
10785964|NCT03048422|BG003|Baseline|Total|Total of all reporting groups
10785965|NCT03048422|FG000|Participant Flow|Arm 1: Maternal DTG+FTC/TAF|Mothers randomized to receive DTG+FTC/TAF
11194570|NCT02153099|OG003|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
10785966|NCT03048422|FG001|Participant Flow|Arm 2: Maternal DTG+FTC/TDF|Mothers randomized to receive DTG+FTC/TDF
10785967|NCT03048422|FG002|Participant Flow|Arm 3: Maternal EFV/FTC/TDF|Mothers randomized to receive EFV/FTC/TDF
10785968|NCT03048422|OG000|Outcome|Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF|Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF
10785969|NCT03048422|OG001|Outcome|Arm 3: Maternal EFV/FTC/TDF|Mothers randomized to receive EFV/FTC/TDF
10785970|NCT03048422|OG000|Outcome|Arm 1: Maternal DTG+FTC/TAF|Mothers randomized to receive DTG+FTC/TAF
10785971|NCT03048422|OG001|Outcome|Arm 2: Maternal DTG+FTC/TDF|Mothers randomized to receive DTG+FTC/TDF
10785972|NCT03048422|OG002|Outcome|Arm 3: Maternal EFV/FTC/TDF|Mothers randomized to receive EFV/FTC/TDF
10785973|NCT03048422|OG000|Outcome|Arm 1 Infants|Infants born to women who were randomized to receive DTG+FTC/TAF during pregnancy and postpartum
10785974|NCT03048422|OG001|Outcome|Arm 2 Infants|Infants born to women who were randomized to receive DTG+FTC/TDF during pregnancy and postpartum
11194571|NCT02153099|OG004|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
10785975|NCT03048422|OG002|Outcome|Arm 3 Infants|Infants born to women who were randomized to receive EFV/FTC/TDF during pregnancy and postpartum
10785976|NCT03048422|OG000|Outcome|Arms 1 and 2 Infants|Combined group of infants born to women who were randomized to receive DTG+FTC/TAF or DTG+FTC/TDF during pregnancy and postpartum
10785977|NCT03048422|OG001|Outcome|Arm 3 Infants|Infants born to women who were randomized to receive EFV/FTC/TDF during pregnancy and postpartum
10785978|NCT03048422|EG000|Reported Event|Arm 1: Maternal DTG+FTC/TAF|Mothers randomized to receive DTG+FTC/TAF
10785979|NCT03048422|EG001|Reported Event|Arm 2: Maternal DTG+FTC/TDF|Mothers randomized to receive DTG+FTC/TDF
10785980|NCT03048422|EG002|Reported Event|Arm 3: Maternal EFV/FTC/TDF|Mothers randomized to receive EFV/FTC/TDF
10785981|NCT03048422|EG003|Reported Event|Arm 1 Infants|Infants born to women who were randomized to receive DTG+FTC/TAF during pregnancy and postpartum
10785982|NCT03048422|EG004|Reported Event|Arm 2 Infants|Infants born to women who were randomized to receive DTG+FTC/TDF during pregnancy and postpartum
10785983|NCT03048422|EG005|Reported Event|Arm 3 Infants|Infants born to women who were randomized to receive EFV/FTC/TDF during pregnancy and postpartum
10785984|NCT03032068|BG000|Baseline|Home-based Monitoring|All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
10785985|NCT03032068|FG000|Participant Flow|Home-based Monitoring|All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
10785986|NCT03032068|OG000|Outcome|Home-based Monitoring|All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
10785987|NCT03032068|EG000|Reported Event|Home-based Monitoring|All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
10785988|NCT02965729|BG000|Baseline|No Pedometer|Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
10785989|NCT02965729|BG001|Baseline|Pedometer Only|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
10785990|NCT02965729|BG002|Baseline|Pedometer Plus Step Goals|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
10785991|NCT02965729|BG003|Baseline|Total|Total of all reporting groups
10785992|NCT02965729|FG000|Participant Flow|No Pedometer|Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
11194572|NCT02153099|OG005|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
11194573|NCT02153099|OG006|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
11194574|NCT02153099|EG000|Reported Event|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
11194575|NCT02153099|EG001|Reported Event|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
11194576|NCT02153099|EG002|Reported Event|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
11194577|NCT02153099|EG003|Reported Event|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
11194578|NCT02153099|EG004|Reported Event|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
11194579|NCT02153099|EG005|Reported Event|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
11194580|NCT02153099|EG006|Reported Event|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
11194581|NCT02153112|BG000|Baseline|Cohort 1, Group 1: 1 Dose|Children 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.
11194582|NCT02153112|BG001|Baseline|Cohort 1, Group 1: 2 Doses|Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.
11194583|NCT02153112|BG002|Baseline|Cohort 1, Group 2: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.
11194584|NCT02153112|BG003|Baseline|Cohort 1, Group 2: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194585|NCT02153112|BG004|Baseline|Cohort 1, Group 2a: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
11194586|NCT02153112|BG005|Baseline|Cohort 1, Group 2a: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194587|NCT02153112|BG006|Baseline|Cohort 1, Group 3: 1 Dose|Toddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
11194588|NCT02153112|BG007|Baseline|Cohort 1, Group 3: 2 Doses|Toddlers 6 months to <1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194589|NCT02153112|BG008|Baseline|Cohort 2, Group 4: 2 Doses|Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
11382127|NCT02059265|OG000|Outcome|Treatment (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11382128|NCT02059265|EG000|Reported Event|Treatment (Dasatinib)|"Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dasatinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11194590|NCT02153112|BG009|Baseline|Cohort 2, Group 4: 3 Doses|Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
11194591|NCT02153112|BG010|Baseline|Total|Total of all reporting groups
11382129|NCT02017717|BG000|Baseline|Cohort 1: Arm N1+I3|Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382130|NCT02017717|BG001|Baseline|Cohort 1: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382131|NCT02017717|BG002|Baseline|Cohort 1b: Arm N3+I1|Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382132|NCT02017717|BG003|Baseline|Cohort 2: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382133|NCT02017717|BG004|Baseline|Cohort 2: Arm B|Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
11382134|NCT02017717|BG005|Baseline|Part A Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382135|NCT02017717|BG006|Baseline|Part A Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
10785993|NCT02965729|FG001|Participant Flow|Pedometer Only|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
10785994|NCT02965729|FG002|Participant Flow|Pedometer Plus Step Goals|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
10785995|NCT02965729|OG000|Outcome|No Pedometer|Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
10785996|NCT02965729|OG001|Outcome|Pedometer Only|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
10785997|NCT02965729|OG002|Outcome|Pedometer Plus Step Goals|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
10785998|NCT02965729|EG000|Reported Event|No Pedometer|Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
10785999|NCT02965729|EG001|Reported Event|Pedometer Only|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
10786000|NCT02965729|EG002|Reported Event|Pedometer Plus Step Goals|In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
10786001|NCT02835690|BG000|Baseline|Pembrolizumab 2 mg/kg|Participants receive pembrolizumab 2 mg/kg administered intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786002|NCT02835690|BG001|Baseline|Pembrolizumab 10 mg/kg|Participants receive pembrolizumab 10 mg/kg administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786003|NCT02835690|BG002|Baseline|Pembrolizumab 200 mg Fixed Dose|Participants receive pembrolizumab 200 mg fixed dose administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786004|NCT02835690|BG003|Baseline|Total|Total of all reporting groups
10786005|NCT02835690|FG000|Participant Flow|Pembrolizumab 2 mg/kg|Participants receive pembrolizumab 2 mg/kg administered intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786006|NCT02835690|FG001|Participant Flow|Pembrolizumab 10 mg/kg|Participants receive pembrolizumab 10 mg/kg administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786007|NCT02835690|FG002|Participant Flow|Pembrolizumab 200 mg Fixed Dose|Participants receive pembrolizumab 200 mg fixed dose administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786008|NCT02835690|OG000|Outcome|Pembrolizumab 2 mg/kg|Participants receive pembrolizumab 2 mg/kg administered intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786009|NCT02835690|OG001|Outcome|Pembrolizumab 10 mg/kg|Participants receive pembrolizumab 10 mg/kg administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786010|NCT02835690|OG002|Outcome|Pembrolizumab 200 mg Fixed Dose|Participants receive pembrolizumab 200 mg fixed dose administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days and subsequent cycles are 21 days.
10786011|NCT02835690|EG000|Reported Event|Pembrolizumab 2 mg/kg|Participants receive pembrolizumab 2 mg/kg administered intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
10786012|NCT02835690|EG001|Reported Event|Pembrolizumab 10 mg/kg|Participants receive pembrolizumab 10 mg/kg administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
10786013|NCT02835690|EG002|Reported Event|Pembrolizumab 200 mg Fixed Dose|Participants receive pembrolizumab 200 mg fixed dose administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
10786014|NCT02828982|BG000|Baseline|All Study Participants|This group represents all participants enrolled in the study.
10803760|NCT02134028|OG001|Outcome|Participants From DRI12544: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11194592|NCT02153112|FG000|Participant Flow|Cohort 1, Group 1: 1 Dose|Children 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.
11194593|NCT02153112|FG001|Participant Flow|Cohort 1, Group 1: 2 Doses|Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.
10786015|NCT02828982|FG000|Participant Flow|Powered Ankle Prosthesis, Then Unpowered Prosthesis|In this condition, the participant was fitted with a powered prosthetic ankle by a certified prosthetist to start the study. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket. They then wore their prescribed prosthesis for 2 weeks, while their activity was monitored, before returning to the lab for testing.
10786016|NCT02828982|FG001|Participant Flow|Unpowered Prosthesis, Then Powered Ankle Prosthesis|In this arm, participants will start in their clinically prescribed dynamic response foot. They first wore their prescribed prosthesis for 2 weeks, while their activity was monitored. They then came to the laboratory for testing. Participants were then fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket.
10786017|NCT02828982|OG000|Outcome|Unpowered Prosthesis|This condition is any unpowered prosthesis that was clinically prescribed to the patient
10786018|NCT02828982|OG001|Outcome|BiOM Powered Prosthesis|This device is a prosthetic ankle which is battery powered and supplies active ankle power.
10786019|NCT02828982|OG001|Outcome|BiOM Powered Prostheis|This device is a prosthetic ankle which is battery powered and supplies active ankle power.
10786020|NCT02828982|OG001|Outcome|BiOM Powered Prosthesis|This device is a prosthetic ankle which is battery powered and supplies active ankle power
10786021|NCT02828982|EG000|Reported Event|Powered Ankle Prosthesis|"In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). After accommodation, participants wore the device for 2 weeks.~Powered ankle prosthesis: This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.~We monitored for adverse events the entire time the participant had the device at home for accommodation and monitoring (~ 3 weeks)"
10786022|NCT02828982|EG001|Reported Event|Unpowered Prosthesis|"In this arm, participants will wear their clinically prescribed dynamic response foot (unpowered prosthesis). This period is 2 weeks long.~Dynamic Response Foot: This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.~We monitored for adverse events the entire time the person wore their device at home and were monitored (2 weeks)."
10786023|NCT02823457|BG000|Baseline|VBMI Intervention Group|"All patients will receive a 12 week VBMI intervention to promote treatment completion~VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist"
10786024|NCT02823457|FG000|Participant Flow|VBMI Intervention Group|"All patients will receive a 12 week VBMI intervention to promote treatment completion~VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist"
10786025|NCT02823457|OG000|Outcome|VBMI Intervention Group|"All patients will receive a 12 week VBMI intervention to promote treatment completion~VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist"
10786026|NCT02823457|EG000|Reported Event|VBMI Intervention Group|"All patients will receive a 12 week VBMI intervention to promote treatment completion~VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist"
10786027|NCT02815280|BG000|Baseline|FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786028|NCT02815280|BG001|Baseline|Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786029|NCT02815280|BG002|Baseline|Total|Total of all reporting groups
10786030|NCT02815280|FG000|Participant Flow|FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786031|NCT02815280|FG001|Participant Flow|Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786032|NCT02815280|OG000|Outcome|FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786033|NCT02815280|OG001|Outcome|Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786034|NCT02815280|OG000|Outcome|Double-blind-FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786035|NCT02815280|OG001|Outcome|Double-blind-Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786036|NCT02815280|OG002|Outcome|Open-label-FMX-101, 4% Minocycline Foam|Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
10786037|NCT02815280|EG000|Reported Event|Double-blind-FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786038|NCT02815280|EG001|Reported Event|Double-blind-Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786039|NCT02815280|EG002|Reported Event|Open-label-FMX-101, 4% Minocycline Foam|Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
10786040|NCT02815267|BG000|Baseline|Double-blind-FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786041|NCT02815267|BG001|Baseline|Double-blind-Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786042|NCT02815267|BG002|Baseline|Total|Total of all reporting groups
10786043|NCT02815267|FG000|Participant Flow|FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786044|NCT02815267|FG001|Participant Flow|Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786045|NCT02815267|OG000|Outcome|FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786046|NCT02815267|OG001|Outcome|Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786047|NCT02815267|OG000|Outcome|Double-blind-FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786048|NCT02815267|OG001|Outcome|Double-blind-Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786049|NCT02815267|OG002|Outcome|Open-label-FMX-101, 4% Minocycline Foam|Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
10786050|NCT02815267|EG000|Reported Event|Double-blind-FMX-101, 4% Minocycline Foam|Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.
10786051|NCT02815267|EG001|Reported Event|Double-blind-Vehicle Foam|Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
10786052|NCT02815267|EG002|Reported Event|Open-label-FMX-101, 4% Minocycline Foam|Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
10786053|NCT02802228|BG000|Baseline|Ifetroban|"90 day course of oral ifetroban following intravenous loading dose~Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule"
10786054|NCT02802228|BG001|Baseline|Placebo|"90 day course of placebo following intravenous dose of D5W~Placebo: matched placebo delivered as infusion and oral capsule"
10786055|NCT02802228|BG002|Baseline|Total|Total of all reporting groups
10786056|NCT02802228|FG000|Participant Flow|Ifetroban|"90 day course of oral ifetroban following intravenous loading dose~Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule"
10786057|NCT02802228|FG001|Participant Flow|Placebo|"90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)~Placebo: matched placebo delivered as infusion and oral capsule"
10786058|NCT02802228|OG000|Outcome|Ifetroban|"90 day course of oral ifetroban following intravenous loading dose~Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule"
10786059|NCT02802228|OG001|Outcome|Placebo|"90 day course of placebo following intravenous dose of D5W~Placebo: matched placebo delivered as infusion and oral capsule"
10786060|NCT02802228|EG000|Reported Event|Ifetroban|"90 day course of oral ifetroban following intravenous loading dose~Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule"
10786061|NCT02802228|EG001|Reported Event|Placebo|"90 day course of placebo following intravenous dose of D5W~Placebo: matched placebo delivered as infusion and oral capsule"
10964694|NCT00878722|OG007|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
11241038|NCT02484547|OG000|Outcome|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10786062|NCT02719691|BG000|Baseline|Dose Level 1: Alisertib 30 mg/MLN0128 1 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786063|NCT02719691|BG001|Baseline|Dose Level 2: Alisertib 30 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786064|NCT02719691|BG002|Baseline|Dose Level 3: Alisertib 40 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786065|NCT02719691|BG003|Baseline|Dose Level 3: Alisertib 40 mg/MLN0128 3 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10803761|NCT02134028|OG002|Outcome|Participants From EFC13579: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10964695|NCT00878722|OG000|Outcome|Arm A, Cycle 1 Day 4|
10964696|NCT00878722|OG001|Outcome|Arm A, Cycle 1 Day 5|
10964697|NCT00878722|OG002|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
10786066|NCT02719691|BG004|Baseline|Dose-Expansion of Alisertib and MLN0128|"Group 1:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Group 2:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Pancreatic Cancer Cohort:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786067|NCT02719691|BG005|Baseline|Total|Total of all reporting groups
10786068|NCT02719691|FG000|Participant Flow|Dose Level 1: Alisertib 30 mg/MLN0128 1 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786069|NCT02719691|FG001|Participant Flow|Dose Level 2: Alisertib 30 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786070|NCT02719691|FG002|Participant Flow|Dose Level 3: Alisertib 40 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786071|NCT02719691|FG003|Participant Flow|Dose Level 4: Alisertib 40 mg/MLN0128 3 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786072|NCT02719691|FG004|Participant Flow|Dose-Expansion of Alisertib and MLN0128|"Group 1:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Group 2:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Pancreatic Cancer Cohort:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786073|NCT02719691|OG000|Outcome|Dose-Escalation of Alisertib and MLN0128|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786074|NCT02719691|OG001|Outcome|Dose-Expansion of Alisertib and MLN0128|"Group 1:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Group 2:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Pancreatic Cancer Cohort:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10964698|NCT00878722|EG000|Reported Event|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
11194594|NCT02153112|FG002|Participant Flow|Cohort 1, Group 2: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.
10964699|NCT00878722|EG001|Reported Event|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
10964700|NCT00878722|EG002|Reported Event|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
10964701|NCT00878722|EG003|Reported Event|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
10786075|NCT02719691|OG000|Outcome|Dose Level 1: Alisertib 30 mg/MLN0128 1 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786076|NCT02719691|OG001|Outcome|Dose Level 2: Alisertib 30 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786077|NCT02719691|OG002|Outcome|Dose Level 3: Alisertib 40 mg/MLN0128 2 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786078|NCT02719691|OG003|Outcome|Dose Level 4: Alisertib 40 mg/MLN0128 3 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."
10786079|NCT02719691|OG004|Outcome|Dose-Expansion of Alisertib and MLN0128|"Group 1:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Group 2:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Pancreatic Cancer Cohort:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786080|NCT02719691|EG000|Reported Event|Dose Level 1: Alisertib 30 mg/MLN0128 1 mg|"This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786081|NCT02719691|EG001|Reported Event|Dose Level 2: Alisertib 30 mg/MLN0128 2 mg|The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
10786082|NCT02719691|EG002|Reported Event|Dose Level 3: Alisertib 40 mg/MLN0128 2 mg|The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
10786083|NCT02719691|EG003|Reported Event|Dose Level 4: Alisertib 40 mg/MLN0128 3 mg|The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 3 mg given by mouth (PO) once daily with continuous dosing.
10786084|NCT02719691|EG004|Reported Event|Dose-Expansion of Alisertib and MLN0128|"Group 1:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Group 2:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.~Pancreatic Cancer Cohort:~This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.~Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.~MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."
10786085|NCT02674516|BG000|Baseline|Anodal Stimulation|"Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
10786086|NCT02674516|BG001|Baseline|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
10786087|NCT02674516|BG002|Baseline|Total|Total of all reporting groups
10964702|NCT00878722|EG004|Reported Event|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
10786088|NCT02674516|FG000|Participant Flow|Anodal Stimulation|"Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
10786089|NCT02674516|FG001|Participant Flow|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
10786090|NCT02674516|OG000|Outcome|Anodal Stimulation|"Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
10786091|NCT02674516|OG001|Outcome|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
10786092|NCT02674516|EG000|Reported Event|Anodal Stimulation|"Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.~Transcranial direct current stimulation"
10786093|NCT02674516|EG001|Reported Event|Sham Stimulation|"The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.~Sham transcranial direct current stimulation"
10786094|NCT02655016|BG000|Baseline|Placebo|Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786095|NCT02655016|BG001|Baseline|Niraparib|Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786096|NCT02655016|BG002|Baseline|Total|Total of all reporting groups
10786097|NCT02655016|FG000|Participant Flow|Placebo|Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10850643|NCT00303719|EG001|Reported Event|Standard Risk Patients|Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder
11194595|NCT02153112|FG003|Participant Flow|Cohort 1, Group 2: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194596|NCT02153112|FG004|Participant Flow|Cohort 1, Group 2a: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
10850644|NCT00303823|BG000|Baseline|Polyphenon E|
10850645|NCT00303823|BG001|Baseline|Placebo|
10850646|NCT00303823|BG002|Baseline|Total|Total of all reporting groups
10850647|NCT00303823|FG000|Participant Flow|Polyphenon E (Defined Green Tea Catechin Extract)|Patients receive oral Polyphenon E daily for 16 weeks
10850648|NCT00303823|FG001|Participant Flow|Placebo|Patients receive oral placebo once daily for 16 weeks
10786098|NCT02655016|FG001|Participant Flow|Niraparib|Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786099|NCT02655016|OG000|Outcome|Placebo|Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786100|NCT02655016|OG001|Outcome|Niraparib|Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786101|NCT02655016|OG000|Outcome|Niraparib|Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786102|NCT02655016|EG000|Reported Event|Placebo|Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786103|NCT02655016|EG001|Reported Event|Niraparib|Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
10786104|NCT02607046|BG000|Baseline|Exercise|"Exercise Training~Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise."
10786105|NCT02607046|BG001|Baseline|NMES|"Neuromuscular Electrical Stimulation~NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs."
11194597|NCT02153112|FG005|Participant Flow|Cohort 1, Group 2a: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
10786106|NCT02607046|BG002|Baseline|Total|Total of all reporting groups
10786107|NCT02607046|FG000|Participant Flow|Exercise|"Exercise Training~Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise."
10786108|NCT02607046|FG001|Participant Flow|NMES|"Neuromuscular Electrical Stimulation~NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs."
10786109|NCT02607046|OG000|Outcome|Exercise|"Exercise Training~Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise."
10786110|NCT02607046|OG001|Outcome|NMES|"Neuromuscular Electrical Stimulation~NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs."
10786111|NCT02607046|EG000|Reported Event|Exercise|"Exercise Training~Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise."
10786112|NCT02607046|EG001|Reported Event|NMES|"Neuromuscular Electrical Stimulation~NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs."
10803762|NCT02134028|OG003|Outcome|Participants From EFC13579: Dupilumab/Dupilumab|Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10850649|NCT00303823|OG000|Outcome|Polyphenon E|
10850650|NCT00303823|OG001|Outcome|Placebo|
10850651|NCT00303823|EG000|Reported Event|Polyphenon E|
10850652|NCT00303823|EG001|Reported Event|Placebo|
11241039|NCT02484547|OG001|Outcome|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10786113|NCT02505425|BG000|Baseline|Active Intervention for Patients|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786114|NCT02505425|BG001|Baseline|Usual HF Care for Patients|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786115|NCT02505425|BG002|Baseline|Active Intervention for Caregivers|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786116|NCT02505425|BG003|Baseline|Usual HF Care for Caregivers|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786117|NCT02505425|BG004|Baseline|Total|Total of all reporting groups
10786118|NCT02505425|FG000|Participant Flow|Active Intervention for Patients|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786119|NCT02505425|FG001|Participant Flow|Usual HF Care for Patients|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786120|NCT02505425|FG002|Participant Flow|Active Intervention for Caregivers|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786121|NCT02505425|FG003|Participant Flow|Usual HF Care for Caregivers|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786122|NCT02505425|OG000|Outcome|Active Intervention for Patients|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786123|NCT02505425|OG001|Outcome|Usual HF Care for Patients|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10803763|NCT02134028|OG004|Outcome|Participants From EFC13691: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10850653|NCT00303862|BG000|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
10850654|NCT00303862|FG000|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
11241040|NCT02484547|OG002|Outcome|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241041|NCT02484547|EG000|Reported Event|Placebo (PC Period)|Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
10786124|NCT02505425|OG002|Outcome|Active Intervention for Caregivers|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786125|NCT02505425|OG003|Outcome|Usual HF Care for Caregivers|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786126|NCT02505425|EG000|Reported Event|Active Intervention for Patients|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786127|NCT02505425|EG001|Reported Event|Usual HF Care for Patients|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786128|NCT02505425|EG002|Reported Event|Active Intervention for Caregivers|"Behavioral: behavioral support~Usual HF Care + ENABLE CHF-PC~Behavioral Support: ENABLE CHF-PC includes:~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786129|NCT02505425|EG003|Reported Event|Usual HF Care for Caregivers|"Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.~Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
10786130|NCT02487979|BG000|Baseline|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10786131|NCT02487979|FG000|Participant Flow|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10786132|NCT02487979|OG000|Outcome|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10786133|NCT02487979|EG000|Reported Event|Treatment (Glembatumumab Vedotin)|"Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Glembatumumab Vedotin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11194598|NCT02153112|FG006|Participant Flow|Cohort 1, Group 3: 1 Dose|Toddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
10786134|NCT02463448|BG000|Baseline|Autologous Muscle Derived Cells|"Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.~Autologous Muscle Derived Cells: A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall."
10786135|NCT02463448|FG000|Participant Flow|Autologous Muscle Derived Cells|"Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.~Autologous Muscle Derived Cells: A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall."
11194599|NCT02153112|FG007|Participant Flow|Cohort 1, Group 3: 2 Doses|Toddlers 6 months to <1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
10786136|NCT02463448|OG000|Outcome|Autologous Muscle Derived Cells|"Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.~Autologous Muscle Derived Cells: A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall."
10786137|NCT02463448|EG000|Reported Event|Autologous Muscle Derived Cells|"Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.~Autologous Muscle Derived Cells: A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall."
10802108|NCT02707276|BG001|Baseline|Phase 1: Cross-Over, Sham LFMS First|"Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802109|NCT02707276|BG002|Baseline|Phase 2: Parallel, Active LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)"
10802110|NCT02707276|BG003|Baseline|Phase 2: Parallel, Sham LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802111|NCT02707276|BG004|Baseline|Total|Total of all reporting groups
10802112|NCT02707276|FG000|Participant Flow|Cross-Over Phase; Active LFMS First|"Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802113|NCT02707276|FG001|Participant Flow|Cross-Over Phase; Sham LFMS First|"Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802114|NCT02707276|FG002|Participant Flow|Parallel Phase; Active LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)"
10802115|NCT02707276|FG003|Participant Flow|Parallel Phase; Sham LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10803764|NCT02134028|OG005|Outcome|Participants From EFC13691: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10850655|NCT00303862|OG000|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
10850656|NCT00303862|EG000|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
10850657|NCT00303901|BG000|Baseline|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
10964703|NCT00878722|EG005|Reported Event|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10786138|NCT02288897|BG000|Baseline|PV-10|Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 was re-administered at 28-day intervals until complete response, disease progression or study termination.
10786139|NCT02288897|BG001|Baseline|Chemotherapy or Oncolytic Viral Therapy|Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.
10786140|NCT02288897|BG002|Baseline|Total|Total of all reporting groups
10786141|NCT02288897|FG000|Participant Flow|PV-10 (10% Rose Bengal Disodium)|Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 was re-administered at 28-day intervals until complete response, disease progression or study termination.
10786142|NCT02288897|FG001|Participant Flow|Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec)|Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.
10786143|NCT02288897|OG000|Outcome|PV-10|Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.
10786144|NCT02288897|OG001|Outcome|Chemotherapy or Oncolytic Viral Therapy|Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.
10786145|NCT02288897|EG000|Reported Event|PV-10|"Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.~PV-10 (10% rose bengal disodium)~PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator"
10786146|NCT02288897|EG001|Reported Event|Chemotherapy or Oncolytic Viral Therapy|"Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.~Dacarbazine, temozolomide or talimogene laherparepvec"
10786147|NCT02276547|BG000|Baseline|Treatment|"Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system~Mitral valve replacement: Transcatheter mitral valve replacement"
10786148|NCT02276547|FG000|Participant Flow|Treatment|"Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system~Mitral valve replacement: Transcatheter mitral valve replacement"
10786149|NCT02276547|OG000|Outcome|Treatment|"Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system~Mitral valve replacement: Transcatheter mitral valve replacement"
10786150|NCT02276547|EG000|Reported Event|Treatment|"Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system~Mitral valve replacement: Transcatheter mitral valve replacement"
10786151|NCT02263885|BG000|Baseline|ExAblate Transcranial System Test Arm|"Transcranial ExAblate MRgFUS~Transcranial MRgFUS lesioning of the Globus Pallidum"
10786152|NCT02263885|FG000|Participant Flow|ExAblate Transcranial System Test Arm|"Transcranial ExAblate MRgFUS~Transcranial MRgFUS lesioning of the Globus Pallidum"
10786153|NCT02263885|OG000|Outcome|ExAblate Transcranial System Test Arm|"Transcranial ExAblate MRgFUS~Transcranial MRgFUS lesioning of the Globus Pallidum"
10786154|NCT02263885|OG000|Outcome|ExAblate Transcranial System|"Transcranial ExAblate MRgFUS~ExAblate Transcranial System: Transcranial MRgFUS"
10964704|NCT00878722|EG006|Reported Event|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10786155|NCT02263885|EG000|Reported Event|ExAblate Transcranial System Test Arm|"Transcranial ExAblate MRgFUS~Transcranial MRgFUS lesioning of the Globus Pallidum"
10786156|NCT02213926|BG000|Baseline|ACP-196 100 mg BID|subjects with relapsed/refractory MCL
10786157|NCT02213926|FG000|Participant Flow|ACP-196 100 mg BID|subjects with relapsed/refractory MCL
10786158|NCT02213926|OG000|Outcome|ACP-196 (Acalabrutinib)|ACP-196 (acalabrutinib) 100 mg BID
10786159|NCT02213926|EG000|Reported Event|ACP-196 100 mg BID|subjects with relapsed/refractory MCL
10786160|NCT02008396|BG000|Baseline|Inactive Placebo With Psychotherapy|Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
10786161|NCT02008396|BG001|Baseline|75 mg to 125 mg MDMA With Psychotherapy|Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
10786162|NCT02008396|BG002|Baseline|Total|Total of all reporting groups
10786163|NCT02008396|FG000|Participant Flow|Inactive Placebo With Psychotherapy|Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
10786164|NCT02008396|FG001|Participant Flow|MDMA With Psychotherapy|Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
10786165|NCT02008396|OG000|Outcome|Inactive Placebo With Psychotherapy|Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
10786166|NCT02008396|OG001|Outcome|75 mg to 125 mg MDMA With Psychotherapy|Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
10786167|NCT02008396|EG000|Reported Event|Inactive Placebo With Psychotherapy (Stage 1)|Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
10964705|NCT00878722|EG007|Reported Event|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
10786168|NCT02008396|EG001|Reported Event|75 to 125 mg MDMA With Psychotherapy (Stage 1)|Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
10786169|NCT02008396|EG002|Reported Event|75 to 125 mg MDMA With Psychotherapy (Stage 2)|Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
10786170|NCT01995175|BG000|Baseline|Overall Group|Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
10786171|NCT01995175|FG000|Participant Flow|Overall Group|Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
10786172|NCT01995175|OG000|Outcome|Overall Group|Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
10786173|NCT01995175|EG000|Reported Event|Overall Group|Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
10786174|NCT01883804|BG000|Baseline|Study Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
10786175|NCT01883804|FG000|Participant Flow|Methyldopa Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
10786176|NCT01883804|OG000|Outcome|Study Group|open label treatment; dose escalation of methyldopa
10786177|NCT01883804|EG000|Reported Event|Study Group|"All participants selected to continue with Methyldopa administration.~Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy."
10786178|NCT01804296|BG000|Baseline|Part 2 Active|"Open-label, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786179|NCT01804296|FG000|Participant Flow|Part 2 Active|"Open-label, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
11194600|NCT02153112|FG008|Participant Flow|Cohort 2, Group 4: 2 Doses|Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
10786180|NCT01804296|OG000|Outcome|Part 2 Active|"Open-label, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786181|NCT01804296|EG000|Reported Event|Part 2 Active|"Open-label, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786182|NCT01804270|BG000|Baseline|Part 1 Active|"Blinded, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786183|NCT01804270|BG001|Baseline|Part 1 Sham|"Blinded, sham repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786184|NCT01804270|BG002|Baseline|Total|Total of all reporting groups
10786185|NCT01804270|FG000|Participant Flow|Part 1 Active|"Blinded, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786186|NCT01804270|FG001|Participant Flow|Part 1 Sham|"Blinded, sham repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10803765|NCT02134028|OG006|Outcome|Participants From PDY14192: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10786187|NCT01804270|OG000|Outcome|Part 1 Active|"Blinded, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786188|NCT01804270|OG001|Outcome|Part 1 Sham|"Blinded, sham repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786189|NCT01804270|EG000|Reported Event|Part 1 Active|"Blinded, active repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10786190|NCT01804270|EG001|Reported Event|Part 1 Sham|"Blinded, sham repetitive transcranial magnetic stimulation~Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session."
10964706|NCT00878800|BG000|Baseline|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
10964707|NCT00878800|BG001|Baseline|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
10964708|NCT00878800|BG002|Baseline|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
10964709|NCT00878800|BG003|Baseline|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964710|NCT00878800|BG004|Baseline|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964711|NCT00878800|BG005|Baseline|Total|Total of all reporting groups
11194601|NCT02153112|FG009|Participant Flow|Cohort 2, Group 4: 3 Doses|Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
11194602|NCT02153112|OG000|Outcome|Cohort 1, Group 1: 1 Dose|Children 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.
11194603|NCT02153112|OG001|Outcome|Cohort 1, Group 1: 2 Doses|Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.
11194604|NCT02153112|OG002|Outcome|Cohort 1, Group 2: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.
11194605|NCT02153112|OG003|Outcome|Cohort 1, Group 2: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194606|NCT02153112|OG004|Outcome|Cohort 1, Group 2a: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
11194607|NCT02153112|OG005|Outcome|Cohort 1, Group 2a: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194608|NCT02153112|OG006|Outcome|Cohort 1, Group 3: 1 Dose|Toddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
10964712|NCT00878800|FG000|Participant Flow|Cohort 1: BelDox IV (600/50)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
10964713|NCT00878800|FG001|Participant Flow|Cohort 2: BelDox IV (600/75)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
10964714|NCT00878800|FG002|Participant Flow|Cohort 3: BelDox IV (800/75)|PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
10964715|NCT00878800|FG003|Participant Flow|Cohort 4: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964716|NCT00878800|FG004|Participant Flow|MTD Expansion: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964717|NCT00878800|OG000|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
10964718|NCT00878800|OG001|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964719|NCT00878800|OG000|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
10964720|NCT00878800|OG001|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
10964721|NCT00878800|EG000|Reported Event|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
10964722|NCT00878800|EG001|Reported Event|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
10786204|NCT01338636|BG000|Baseline|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
10786205|NCT01338636|FG000|Participant Flow|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
10786206|NCT01338636|OG000|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
10786207|NCT01338636|EG000|Reported Event|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
10786208|NCT01208974|BG000|Baseline|Phase 1 MTD NAC RT|"Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:~Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy~Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy~Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy~Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy~Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT).~Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT."
10786209|NCT01208974|FG000|Participant Flow|NAC-Sparing Mastectomy|Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4. All participants complete this surgery and post-mastectomy period before being assigned to a dosing arm for prophylactic radiation therapy.
10786210|NCT01208974|FG001|Participant Flow|Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy (Starting Dose)|The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
10786211|NCT01208974|FG002|Participant Flow|Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy|The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
10786212|NCT01208974|FG003|Participant Flow|Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy|The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
10786213|NCT01208974|OG000|Outcome|Prophylactic NAC RT After Nipple-Sparing Mastectomy|"Participants who received NAC RT after nipple-sparing mastectomy at the following dose levels:~Dose Level II: 6 participants receiving 10 fractions at 2.5 grays (gy) for total of 25 Gy.~Dose Level III: 6 participants receiving 10 fractions at 3.0 grays (gy) for total of 30 Gy.~Dose Level IV: 6 participants receiving 10 fractions at 3.5 grays (gy) for total of 35 Gy."
11194609|NCT02153112|OG007|Outcome|Cohort 1, Group 3: 2 Doses|Toddlers 6 months to <1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
10786214|NCT01208974|EG000|Reported Event|NAC-Sparing Mastectomy|Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4.
10786215|NCT01208974|EG001|Reported Event|Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy|The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
10786216|NCT01208974|EG002|Reported Event|Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy|The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
10786217|NCT01208974|EG003|Reported Event|Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy|The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
10786218|NCT00938912|BG000|Baseline|Lacosamide (All Participants)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
10786219|NCT00938912|FG000|Participant Flow|Lacosamide (All Participants)|Participants aged greater than or equal to (≥1) month received either lacosamide (LCM) 2-12 milligrams/kilograms/day (mg/kg/day) (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
10786220|NCT00938912|OG000|Outcome|Lacosamide (All Participants) (SS)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
10786221|NCT00938912|OG000|Outcome|Lacosamide (All Participants) (SS)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
10786222|NCT00938912|OG000|Outcome|Lacosamide (All Participants) (FAS)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Full Analysis Set (FAS) which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
10786223|NCT00938912|OG000|Outcome|Lacosamide (All Participants) (FAS)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
10786224|NCT00938912|EG000|Reported Event|Lacosamide (All Participants) (SS)|Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
10786225|NCT00925652|BG000|Baseline|Lifestyle: Diet|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10786226|NCT00925652|BG001|Baseline|Lifestyle: Diet+Exericise|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10786227|NCT00925652|BG002|Baseline|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786228|NCT00925652|BG003|Baseline|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786229|NCT00925652|BG004|Baseline|Total|Total of all reporting groups
10786230|NCT00925652|FG000|Participant Flow|Lifestyle: Diet|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
11194610|NCT02153112|OG000|Outcome|Cohort 2, Group 4: 2 Doses|Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
11194611|NCT02153112|OG001|Outcome|Cohort 2, Group 4: 3 Doses|Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
11194612|NCT02153112|OG008|Outcome|Cohort 2, Group 4: 2 Doses|Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
10786231|NCT00925652|FG001|Participant Flow|Lifestyle: Diet+Exericise|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10786232|NCT00925652|FG002|Participant Flow|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786233|NCT00925652|FG003|Participant Flow|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786234|NCT00925652|OG000|Outcome|Lifestyle: Diet|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Lifestyle: Diet"
10786235|NCT00925652|OG001|Outcome|Lifestyle: Diet+Exericise|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Lifestyle: Diet~Lifestyle: Diet+Exercise"
10786236|NCT00925652|OG002|Outcome|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months~Bevacizumab~Cyclophosphamide~Methotrexate~Lifestyle: Diet"
10786237|NCT00925652|OG003|Outcome|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months~Bevacizumab~Cyclophosphamide~Methotrexate~Lifestyle: Diet~Lifestyle: Diet+Exercise"
10786238|NCT00925652|OG000|Outcome|Lifestyle: Diet|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10786239|NCT00925652|OG001|Outcome|Lifestyle: Diet+Exericise|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10786240|NCT00925652|OG002|Outcome|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786241|NCT00925652|OG003|Outcome|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786242|NCT00925652|OG000|Outcome|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786243|NCT00925652|OG001|Outcome|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786244|NCT00925652|OG000|Outcome|Observation + Diet/Diet and Exercise|"Patients in observation group will receive following diet or diet + exercise intervention.~The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor."
10786245|NCT00925652|OG001|Outcome|Bevicizumab+CM|Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months Patients will receive diet or diet + exercise intervention.
10786246|NCT00925652|EG000|Reported Event|Lifestyle: Diet|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
10964723|NCT00878800|EG002|Reported Event|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
11194613|NCT02153112|OG009|Outcome|Cohort 2, Group 4: 3 Doses|Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
11382136|NCT02017717|BG007|Baseline|Part B Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382137|NCT02017717|BG008|Baseline|Part B Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382138|NCT02017717|BG009|Baseline|Total|Total of all reporting groups
11382139|NCT02017717|FG000|Participant Flow|Cohort 1: Arm N1+I3|Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382140|NCT02017717|FG001|Participant Flow|Cohort 1: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382141|NCT02017717|FG002|Participant Flow|Cohort 1b: Arm N3+I1|Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382142|NCT02017717|FG003|Participant Flow|Cohort 2: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382143|NCT02017717|FG004|Participant Flow|Cohort 2: Arm B|Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
11382144|NCT02017717|FG005|Participant Flow|Part A Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382145|NCT02017717|FG006|Participant Flow|Part A Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382146|NCT02017717|FG007|Participant Flow|Part B Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382147|NCT02017717|FG008|Participant Flow|Part B Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382148|NCT02017717|OG000|Outcome|Cohort 1: Arm N1+I3|Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382149|NCT02017717|OG001|Outcome|Cohort 1: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
10786247|NCT00925652|EG001|Reported Event|Lifestyle: Diet+Exericise|The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
11241042|NCT02484547|EG001|Reported Event|BIIB037 Low Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241043|NCT02484547|EG002|Reported Event|BIIB037 High Dose (PC Period)|Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
11241044|NCT02484547|EG003|Reported Event|BIIB037 Late Start: Low Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11382150|NCT02017717|OG002|Outcome|Cohort 1b: Arm N3+I1|Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382151|NCT02017717|OG003|Outcome|Part A Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382152|NCT02017717|OG004|Outcome|Part A Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382153|NCT02017717|OG005|Outcome|Part B Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382154|NCT02017717|OG006|Outcome|Part B Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382155|NCT02017717|OG000|Outcome|Cohort 2: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382156|NCT02017717|OG001|Outcome|Cohort 2: Arm B|Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
11382157|NCT02017717|OG000|Outcome|Part A Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382158|NCT02017717|OG001|Outcome|Part A Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382159|NCT02017717|OG002|Outcome|Part B Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
10786248|NCT00925652|EG002|Reported Event|Lifestyle: Diet and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786249|NCT00925652|EG003|Reported Event|Lifestyle: Diet+Exericise and Bevicizumab+CM|"The dietary intervention focuses on the Food Pyramid, emphasizing diet that is low in fat and high in fruits, vegetables and fiber. The exercise intervention is comprised of a target physical activity goal of 180 minutes of moderate-intensity activity each week. Patients receive a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.~Bevicizumab: 15 mg/kg administered intravenously day 1 of a 3-week cycle for 6 months and day 1 of a 6 week cycle up to 2 years Cyclophosphamide: 50 mg orally each day of a 3-week cycle for 6 months Methotrexate: 2.5 mg orally twice daily of a 3-week cycle for 6 months"
10786250|NCT00676715|BG000|Baseline|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
10786251|NCT00676715|BG001|Baseline|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786252|NCT00676715|BG002|Baseline|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
10786253|NCT00676715|BG003|Baseline|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786254|NCT00676715|BG004|Baseline|Total|Total of all reporting groups
10786255|NCT00676715|FG000|Participant Flow|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
10786256|NCT00676715|FG001|Participant Flow|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786257|NCT00676715|FG002|Participant Flow|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
10786258|NCT00676715|FG003|Participant Flow|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786259|NCT00676715|OG000|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
10786260|NCT00676715|OG001|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786261|NCT00676715|OG002|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
10786262|NCT00676715|OG003|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786263|NCT00676715|EG000|Reported Event|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
11194614|NCT02153112|EG000|Reported Event|Cohort 1, Group 1: 1 Dose|Children 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.
11194615|NCT02153112|EG001|Reported Event|Cohort 1, Group 1: 2 Doses|Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.
11241045|NCT02484547|EG004|Reported Event|BIIB037 Late Start: High Dose (LTE Period)|Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11382160|NCT02017717|OG003|Outcome|Part B Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382161|NCT02017717|EG000|Reported Event|Cohort 1: Arm N1+I3|Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382162|NCT02017717|EG001|Reported Event|Cohort 1: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382163|NCT02017717|EG002|Reported Event|Cohort 1b: Arm N3+I1|Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
11382164|NCT02017717|EG003|Reported Event|Cohort 2: Arm N3|Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
11382165|NCT02017717|EG004|Reported Event|Cohort 2: Arm B|Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
11382166|NCT02017717|EG005|Reported Event|Part A Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382167|NCT02017717|EG006|Reported Event|Part A Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382168|NCT02017717|EG007|Reported Event|Part B Cohort 1c: Arm N3+RT+TMZ|Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
11382169|NCT02017717|EG008|Reported Event|Part B Cohort 1d: Arm N3+RT|Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
11382170|NCT01886872|BG000|Baseline|Arm A (Rituximab, Bendamustine Hydrochloride)|Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.
11382171|NCT01886872|BG001|Baseline|Arm B (Ibrutinib)|Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382172|NCT01886872|BG002|Baseline|Arm C (Ibrutinib, Rituximab)|Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382173|NCT01886872|BG003|Baseline|Total|Total of all reporting groups
11382174|NCT01886872|FG000|Participant Flow|Arm A (Rituximab, Bendamustine Hydrochloride)|Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.
11382175|NCT01886872|FG001|Participant Flow|Arm B (Ibrutinib)|Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382176|NCT01886872|FG002|Participant Flow|Arm C (Ibrutinib, Rituximab)|Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382177|NCT01886872|OG000|Outcome|Arm A (Rituximab, Bendamustine Hydrochloride)|Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.
11382178|NCT01886872|OG001|Outcome|Arm B (Ibrutinib)|Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382179|NCT01886872|OG002|Outcome|Arm C (Ibrutinib, Rituximab)|Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382180|NCT01886872|EG000|Reported Event|Arm A (Rituximab, Bendamustine Hydrochloride)|Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.
11382181|NCT01886872|EG001|Reported Event|Arm B (Ibrutinib)|Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382182|NCT01886872|EG002|Reported Event|Arm C (Ibrutinib, Rituximab)|Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382183|NCT01886872|EG003|Reported Event|Arm B Crossover|Arm A patients experiencing disease progression crossover to Arm B.
11382184|NCT01880957|BG000|Baseline|Patients With Depression|"Patients with Bipolar depression will receive lithium administered as follows: Day 1, 2 and 3, 300 mg bid; Days 4-7 lithium 300 qam and 600 qhs. Lithium level will be checked as close to Day 7 as possible and titrated to a therapeutic plasma level of 0.8-1.2 mEq/l. Subjects will not undergo lithium monotherapy if they have a documented history of at least two failed trials of lithium of at least 4 weeks duration with therapeutic blood levels for a major depressive episode~Lithium"
10786264|NCT00676715|EG001|Reported Event|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786265|NCT00676715|EG002|Reported Event|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
10786266|NCT00676715|EG003|Reported Event|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
10786267|NCT00579826|BG000|Baseline|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
10786268|NCT00579826|BG001|Baseline|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
10786269|NCT00579826|BG002|Baseline|Total|Total of all reporting groups
10786270|NCT00579826|FG000|Participant Flow|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
10786271|NCT00579826|FG001|Participant Flow|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
10786272|NCT00579826|OG000|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
10786273|NCT00579826|OG001|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
10786274|NCT00579826|EG000|Reported Event|Letrozole, 2.5 mg Daily for 12 Months|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
10786275|NCT00579826|EG001|Reported Event|Placebo for 6 Months; Open Label Letrozole 2.5 mg Daily|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
10786276|NCT00322218|BG000|Baseline|Zevalin|Zevalin Therapeutic Regimen: Day 1: 250 mg/m^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m^2 Rituxan followed by 0.4 mCi/kg Zevalin.
10786277|NCT00322218|BG001|Baseline|Observation|Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
10786278|NCT00322218|BG002|Baseline|Total|Total of all reporting groups
10786279|NCT00322218|FG000|Participant Flow|Zevalin|Zevalin Therapeutic Regimen: Day 1: 250 milligram per meter square (mg/m^2) Rituxan followed by 5 millicurie (mCi) 111In Zevalin. Day 7: 250 mg/m^2 Rituxan followed by 0.4 millicurie/kilogram (mCi/kg) Zevalin.
10786280|NCT00322218|FG001|Participant Flow|Observation|Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
10786281|NCT00322218|OG000|Outcome|Zevalin|Zevalin Therapeutic Regimen: Day 1: 250 mg/m^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m^2 Rituxan followed by 0.4 mCi/kg Zevalin.
11194616|NCT02153112|EG002|Reported Event|Cohort 1, Group 2: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.
10786282|NCT00322218|OG001|Outcome|Observation|Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
10786283|NCT00322218|EG000|Reported Event|Zevalin|Zevalin Therapeutic Regimen: Day 1: 250 mg/m^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m^2 Rituxan followed by 0.4 mCi/kg Zevalin.
10786284|NCT00322218|EG001|Reported Event|Observation|Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse.
10786285|NCT00186888|BG000|Baseline|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
10786286|NCT00186888|BG001|Baseline|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786287|NCT00186888|BG002|Baseline|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
10786288|NCT00186888|BG003|Baseline|Total|Total of all reporting groups
10786289|NCT00186888|FG000|Participant Flow|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
10964724|NCT00878800|EG003|Reported Event|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
11194617|NCT02153112|EG003|Reported Event|Cohort 1, Group 2: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194618|NCT02153112|EG004|Reported Event|Cohort 1, Group 2a: 1 Dose|Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
11194619|NCT02153112|EG005|Reported Event|Cohort 1, Group 2a: 2 Doses|Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11194620|NCT02153112|EG006|Reported Event|Cohort 1, Group 3: 1 Dose|Toddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
11194621|NCT02153112|EG007|Reported Event|Cohort 1, Group 3: 2 Doses|Toddlers 6 months to <1 year of age received 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
11241046|NCT02484547|EG005|Reported Event|BIIB037 Early Start: Low Dose (LTE Period)|Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11382185|NCT01880957|BG001|Baseline|Healthy Volunteers|Participants in this group underwent baseline assessment for Hamilton Depression Rating Scale and Baseline PET and MRI Imaging. No treatment was provided for this group.
11382186|NCT01880957|BG002|Baseline|Total|Total of all reporting groups
11382187|NCT01880957|FG000|Participant Flow|Patients With Depression|"Patients in this condition will receive lithium administered as follows: Day 1, 2 and 3, 300 mg bid; Days 4-7 lithium 300 qam and 600 qhs. Lithium level will be checked as close to Day 7 as possible and titrated to a therapeutic plasma level of 0.8-1.2 mEq/l. Subjects will not undergo lithium monotherapy if they have a documented history of at least two failed trials of lithium of at least 4 weeks duration with therapeutic blood levels for a major depressive episode~Lithium"
11382188|NCT01880957|FG001|Participant Flow|Healthy Volunteers|Participants in this group underwent baseline assessment for Hamilton Depression Rating Scale and Baseline PET and MRI Imaging. No treatment was provided for this group.
11382189|NCT01880957|OG000|Outcome|Patients With BPD|Participants in this group included patients with bipolar depression who were subsequently treated with Lithium. Following baseline PET and MRI scans, treatment was initiated with lithium monotherapy. In brief: days 1-3: 300mg 2x/day, days 4-7: 300mg every morning and 600mg every night; titration to a therapeutic plasma level of 0.8-1.2 mEq/l. Following eight weeks of treatment, patients were rescanned with PET and MRI and reassessed with the HDRS-24.
11382190|NCT01880957|OG000|Outcome|Prediction by Pre-treatment 5-HTT|Data analysis to determine whether pre-treatment 5-HTT binding potential along with pre-treatment HDRS-24 predicted treatment response (remission status).
11382191|NCT01880957|OG001|Outcome|Prediction by Pre-treatment 5-HT1A|Data analysis to determine whether pre-treatment 5-HT1A binding potential along with pre-treatment HDRS-24 predicted treatment response (remission status).
11382192|NCT01880957|OG002|Outcome|Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A|Data analysis to determine whether pre-treatment 5-HTT & 5-HT1A binding potential along with pre-treatment HDRS-24 predicted treatment response (remission status).
11382193|NCT01880957|OG000|Outcome|Healthy Volunteers|Control participants for baseline measures
11382194|NCT01880957|OG001|Outcome|Pre-treatment 5-HTT Binding Potential (Baseline)|Participants that presented with Bipolar depression upon enrollment into the study
11382195|NCT01880957|OG002|Outcome|Post-treatment 5-HTT Binding Potential (8 Weeks)|Participants that presented with Bipolar depression and were treated with Lithium for 8 weeks.
11382196|NCT01880957|OG001|Outcome|Pre-treatment 5-HT1A Binding Potential (Baseline)|Participants that presented with Bipolar depression upon enrollment into the study
11382197|NCT01880957|OG002|Outcome|Post-treatment 5-HT1A Binding Potential (8 Weeks)|Participants that presented with Bipolar depression and were treated with Lithium for 8 weeks.
11382198|NCT01880957|OG000|Outcome|Change in 5-HTT Binding Potential vs. Treatment Response|Data analysis to determine whether there is relationship between the change in 5-HTT binding potential and treatment response.
11382199|NCT01880957|OG001|Outcome|Change in 5-HT1A Binding Potential and Treatment Response|Data analysis to determine whether there is relationship between the change in 5-HTT binding potential and treatment response.
11382200|NCT01880957|EG000|Reported Event|Patients With Depression|"Bipolar patients with this condition will receive lithium administered as follows: Day 1, 2 and 3, 300 mg bid; Days 4-7 lithium 300 qam and 600 qhs. Lithium level will be checked as close to Day 7 as possible and titrated to a therapeutic plasma level of 0.8-1.2 mEq/l. Subjects will not undergo lithium monotherapy if they have a documented history of at least two failed trials of lithium of at least 4 weeks duration with therapeutic blood levels for a major depressive episode~Lithium"
11382201|NCT01880957|EG001|Reported Event|Healthy Volunteers|Participants in this group underwent baseline assessment for Hamilton Depression Rating Scale and Baseline PET and MRI Imaging. No treatment was provided for this group.
11382202|NCT01856192|BG000|Baseline|Arm A (R2CHOP)|Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382203|NCT01856192|BG001|Baseline|Arm B (RCHOP)|Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382204|NCT01856192|BG002|Baseline|Total|Total of all reporting groups
11194622|NCT02153112|EG008|Reported Event|Cohort 2, Group 4: 2 Doses|Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
11194623|NCT02153112|EG009|Reported Event|Cohort 2, Group 4: 3 Doses|Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.
11194624|NCT02153346|BG000|Baseline|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
11194625|NCT02153346|FG000|Participant Flow|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
11194626|NCT02153346|OG000|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
11194627|NCT02153346|OG000|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base. Only participants actively working who completed the questionnaires were included in the analysis of productivity.
11194628|NCT02153346|EG000|Reported Event|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
11194629|NCT02153359|BG000|Baseline|All Participants|A High Efficiency Particulate Air Cleaner (HEPA) intervention (experimental arm) or sham air cleaner (sham comparator) will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. After this one month intervention period, participants will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the other arm.
11194630|NCT02153359|FG000|Participant Flow|Air Cleaner Then Sham Air Cleaner|A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
11382205|NCT01856192|FG000|Participant Flow|Arm A (R2CHOP)|Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382206|NCT01856192|FG001|Participant Flow|Arm B (RCHOP)|Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382207|NCT01856192|OG000|Outcome|Arm A (R2CHOP)|Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382208|NCT01856192|OG001|Outcome|Arm B (RCHOP)|Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382209|NCT01856192|EG000|Reported Event|Arm A (R2CHOP)|Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11382210|NCT01856192|EG001|Reported Event|Arm B (RCHOP)|Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11194631|NCT02153359|FG001|Participant Flow|Sham Air Cleaner Then Air Cleaner|A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period for at least one month prior to cross-over to the experimental arm.
10786290|NCT00186888|FG001|Participant Flow|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786291|NCT00186888|FG002|Participant Flow|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
10786292|NCT00186888|OG000|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786293|NCT00186888|OG000|Outcome|Stratum B|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~Two patients (3 eyes) in stratum B received external beam radiation therapy (EBRT), and the same 2 patients later required enucleation of the treated eye, thus the failure (event number) and censoring status were not changed for the 2 patients."
10786294|NCT00186888|OG000|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
10786295|NCT00186888|OG000|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786296|NCT00186888|OG001|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786297|NCT00186888|OG002|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786298|NCT00186888|OG003|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786299|NCT00186888|OG000|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786300|NCT00186888|OG001|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC=A and B) and advanced (IC=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10964725|NCT00878800|EG004|Reported Event|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
10964726|NCT00878826|BG000|Baseline|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
11241047|NCT02484547|EG006|Reported Event|BIIB037 Early Start: High Dose (LTE Period)|Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
11241048|NCT02484651|BG000|Baseline|Standard Group|Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.
10786301|NCT00186888|OG002|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786302|NCT00186888|OG003|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786303|NCT00186888|OG000|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786304|NCT00186888|OG001|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786305|NCT00186888|OG002|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786306|NCT00186888|OG003|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
10786307|NCT00186888|OG000|Outcome|Baseline|At study entry.
10786308|NCT00186888|OG001|Outcome|6 Months|Participants at 6 months of age ±3 months.
10786309|NCT00186888|OG002|Outcome|1 Year|Participant age was 1 year ±3 months.
10786310|NCT00186888|OG003|Outcome|2 Years|Participant age was 2 years ±3 months.
10786311|NCT00186888|OG004|Outcome|3 Years|Participant age was 3 years ±3 months.
10786312|NCT00186888|OG005|Outcome|5 Years|Participant age was 5 years ±3 months.
10786313|NCT00186888|OG000|Outcome|5 Years|Participant age was 5 years ±3 months.
10786314|NCT00186888|OG000|Outcome|Participants With Bilateral Retinoblastoma|Results were analyzed for all participants regardless of stratum. All participants received chemotherapy (5 Stratum C, high risk; 11 Stratum A; 27 Stratum B).
10786315|NCT00186888|OG000|Outcome|Baseline|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786316|NCT00186888|OG001|Outcome|Interim Evaluation|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786317|NCT00186888|OG002|Outcome|Additional Evaluation|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10964727|NCT00878826|BG001|Baseline|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
10964728|NCT00878826|BG002|Baseline|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
10964729|NCT00878826|BG003|Baseline|Total|Total of all reporting groups
10964730|NCT00878826|FG000|Participant Flow|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
11382221|NCT01767194|BG000|Baseline|Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)|"CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Temozolomide: Given PO~Temsirolimus: Given IV"
11382222|NCT01767194|BG001|Baseline|Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)|"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.~Dinutuximab: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Sargramostim: Given SC or IV~Temozolomide: Given PO"
11382223|NCT01767194|BG002|Baseline|Total|Total of all reporting groups
11382224|NCT01767194|FG000|Participant Flow|Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)|"CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Temozolomide: Given PO~Temsirolimus: Given IV"
11382225|NCT01767194|FG001|Participant Flow|Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)|"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.~Dinutuximab: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Sargramostim: Given SC or IV~Temozolomide: Given PO"
11382226|NCT01767194|OG000|Outcome|Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)|"CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Temozolomide: Given PO~Temsirolimus: Given IV"
11382227|NCT01767194|OG001|Outcome|Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)|"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.~Dinutuximab: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Sargramostim: Given SC or IV~Temozolomide: Given PO"
11382228|NCT01767194|OG000|Outcome|Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)|"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.~Dinutuximab: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Sargramostim: Given SC or IV~Temozolomide: Given PO"
11382229|NCT01767194|EG000|Reported Event|Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)|"CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Temozolomide: Given PO~Temsirolimus: Given IV"
11382230|NCT01767194|EG001|Reported Event|Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)|"Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.~Dinutuximab: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Optional correlative studies~Sargramostim: Given SC or IV~Temozolomide: Given PO"
11382231|NCT01746173|BG000|Baseline|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
10964731|NCT00878826|FG001|Participant Flow|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
10964732|NCT00878826|FG002|Participant Flow|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
10786318|NCT00186888|OG001|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786319|NCT00186888|OG002|Outcome|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
10786320|NCT00186888|OG000|Outcome|Occupational Therapy Recommended Rehabilitation Services|Occupational therapy evaluation recommended rehabilitation services.
10786321|NCT00186888|OG001|Outcome|Occupational Therapy Did Not Recommend Rehabilitation Services|Occupational therapy evaluation did not recommend rehabilitation services.
10786322|NCT00186888|EG000|Reported Event|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
10786323|NCT00186888|EG001|Reported Event|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
10786324|NCT00186888|EG002|Reported Event|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
10802116|NCT02707276|OG000|Outcome|Phase 1: Cross-Over, Active LFMS First|"Active Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802117|NCT02707276|OG001|Outcome|Phase 1: Cross-Over, Sham LFMS First|"Sham Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802118|NCT02707276|OG002|Outcome|Phase 2: Parallel, Active LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)"
10802119|NCT02707276|OG003|Outcome|Phase 2: Parallel, Sham LFMS|"Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802120|NCT02707276|OG000|Outcome|Phase 1: Cross-Over, Active LFMS First|"Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802121|NCT02707276|OG001|Outcome|Phase 1: Cross-Over, Sham LFMS First|"Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation~Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802122|NCT02707276|EG000|Reported Event|Active LFMS|"Includes subjects in phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days.~Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)"
10964733|NCT00878826|OG000|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
10964734|NCT00878826|OG001|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
11382232|NCT01746173|FG000|Participant Flow|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
11382233|NCT01746173|OG000|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
11382234|NCT01746173|EG000|Reported Event|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
11382235|NCT01734512|BG000|Baseline|Everolimus|"Everolimus tablet will be taken daily by mouth with water. Twenty-eight days will constitute one course and subsequent courses will immediately follow with no break in the administration of the drug. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Patients will also be provided with a drug diary for everolimus. The maximum time on study is 24-months, but if there is no disease progression or adverse events, the patient may speak with a doctor about continuing the treatment off-study.~Everolimus: Everolimus tablet will be taken daily by mouth with water. All patients will be given a dose of 5 mg/m2/dose daily."
11382236|NCT01734512|FG000|Participant Flow|Everolimus|"Everolimus tablet will be taken daily by mouth with water. Twenty-eight days will constitute one course and subsequent courses will immediately follow with no break in the administration of the drug. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Patients will also be provided with a drug diary for everolimus. The maximum time on study is 24-months, but if there is no disease progression or adverse events, the patient may speak with a doctor about continuing the treatment off-study.~Everolimus: Everolimus tablet will be taken daily by mouth with water. All patients will be given a dose of 5 mg/m2/dose daily."
11382237|NCT01734512|OG000|Outcome|Everolimus|"Everolimus tablet will be taken daily by mouth with water. Twenty-eight days will constitute one course and subsequent courses will immediately follow with no break in the administration of the drug. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Patients will also be provided with a drug diary for everolimus. The maximum time on study is 24-months, but if there is no disease progression or adverse events, the patient may speak with a doctor about continuing the treatment off-study.~Everolimus: Everolimus tablet will be taken daily by mouth with water. All patients will be given a dose of 5 mg/m2/dose daily."
11382238|NCT01734512|EG000|Reported Event|Everolimus|"Everolimus tablet will be taken daily by mouth with water. Twenty-eight days will constitute one course and subsequent courses will immediately follow with no break in the administration of the drug. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Patients will also be provided with a drug diary for everolimus. The maximum time on study is 24-months, but if there is no disease progression or adverse events, the patient may speak with a doctor about continuing the treatment off-study.~Everolimus: Everolimus tablet will be taken daily by mouth with water. All patients will be given a dose of 5 mg/m2/dose daily."
11382239|NCT01708954|BG000|Baseline|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382240|NCT01708954|BG001|Baseline|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382241|NCT01708954|BG002|Baseline|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382242|NCT01708954|BG003|Baseline|Total|Total of all reporting groups
11382243|NCT01708954|FG000|Participant Flow|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382244|NCT01708954|FG001|Participant Flow|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786325|NCT04579549|BG000|Baseline|Repeat Testing for SARS-CoV-2|"Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes.~Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2"
10786326|NCT04579549|FG000|Participant Flow|Repeat Testing for SARS-CoV-2|"Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes.~Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2"
10786327|NCT04579549|OG000|Outcome|Repeat Testing for SARS-CoV-2|"Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes.~Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2"
10786328|NCT04579549|EG000|Reported Event|Repeat Testing for SARS-CoV-2|Participants were not monitored for adverse events during sample collection.
10802123|NCT02707276|EG001|Reported Event|Sham LFMS|"Includes subjects in phase 1 crossover: three 20 minute treatments of sham LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days~Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment."
10802124|NCT02666430|BG000|Baseline|Mylan's Insulin Glargine|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Mylan's insulin glargine"
10802125|NCT02666430|BG001|Baseline|Lantus®|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Lantus®"
10802126|NCT02666430|BG002|Baseline|Total|Total of all reporting groups
10802127|NCT02666430|FG000|Participant Flow|Mylan's Insulin Glargine Sequence|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Mylan's insulin glargine"
10802128|NCT02666430|FG001|Participant Flow|Lantus® Sequence|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Lantus®"
10802129|NCT02666430|OG000|Outcome|Mylan's Insulin Glargine|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Mylan's insulin glargine"
10802130|NCT02666430|OG001|Outcome|Lantus®|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Lantus®"
10802131|NCT02666430|EG000|Reported Event|Mylan's Insulin Glargine Sequence|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Mylan's insulin glargine"
10802132|NCT02666430|EG001|Reported Event|Lantus® Sequence|"Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.~Lantus®"
10802133|NCT02643420|BG000|Baseline|Arm 1: SPI-2012 and TC|Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
10802134|NCT02643420|BG001|Baseline|Arm 2: Pegfilgrastim and TC|Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
10802135|NCT02643420|BG002|Baseline|Total|Total of all reporting groups
10802136|NCT02643420|FG000|Participant Flow|Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)|Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor [G-CSF]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
11382245|NCT01708954|FG002|Participant Flow|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10802137|NCT02643420|FG001|Participant Flow|Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)|Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
10802138|NCT02643420|OG000|Outcome|Arm 1: SPI-2012 and TC|Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
10802139|NCT02643420|OG001|Outcome|Arm 2: Pegfilgrastim and TC|Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care.
11194632|NCT02153359|OG000|Outcome|Air Cleaner|A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
11194633|NCT02153359|OG001|Outcome|Sham Air Cleaner|A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the sham comparator arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the experimental arm.
10786329|NCT04622709|BG000|Baseline|Study Drug Administration: Furosemide|"Study participants will receive furosemide oral tablets to be taken twice daily. During study period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. During study period 2 (subsequent 12 weeks), participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.~Furosemide (loop diuretic) Tablets: Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose."
10786330|NCT04622709|FG000|Participant Flow|Study Drug Administration: Furosemide|"Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. This was a single-arm study with 2 periods. Period 1 is the dose escalation phase. During period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. Period 2 is the follow-up phase. During period 2 (subsequent 12 weeks), all participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.~First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose (period 2).~In this single-arm study, all participants received oral furosemide. The protocol was pre-specified to summarize outcome events as a single arm."
10786331|NCT04622709|OG000|Outcome|Study Drug Administration: Furosemide|"Study participants will receive furosemide oral tablets to be taken twice daily. During study period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. During study period 2 (subsequent 12 weeks), participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.~Furosemide (loop diuretic) Tablets: Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose."
10802140|NCT02643420|OG000|Outcome|Arm 1: SPI-2012 and TC -Treatment Period|Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
10964735|NCT00878826|OG002|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
11382246|NCT01708954|OG000|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382247|NCT01708954|OG001|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786332|NCT04622709|EG000|Reported Event|Study Drug Administration: Furosemide|"Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. This was a single-arm study with 2 periods. Period 1 is the dose escalation phase. During period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. Period 2 is the follow-up phase. During period 2 (subsequent 12 weeks), all participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.~First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose (period 2).~All participants received oral furosemide. Per protocol, adverse events were collected irrespective of dose received and were summarized as a single arm."
10786333|NCT04314284|BG000|Baseline|Historical Control Survey|-The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs.
10786334|NCT04314284|BG001|Baseline|I Can PIC|-Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone.
10786335|NCT04314284|BG002|Baseline|Total|Total of all reporting groups
10786336|NCT04314284|FG000|Participant Flow|Historical Control Survey|-The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs.
10786337|NCT04314284|FG001|Participant Flow|I Can PIC|-Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone.
10786338|NCT04314284|OG000|Outcome|Historical Control Survey|-The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs.
10786339|NCT04314284|OG001|Outcome|I Can PIC|-Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone.
10786340|NCT04314284|EG000|Reported Event|Historical Control Survey|-The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs.
10786341|NCT04314284|EG001|Reported Event|I Can PIC|-Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone.
10964736|NCT00878826|EG000|Reported Event|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
10786342|NCT04066491|BG000|Baseline|Safety Run-In Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-specified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m^2) and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
10786343|NCT04066491|BG001|Baseline|Double-blinded Part: Placebo + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786344|NCT04066491|BG002|Baseline|Double-blinded Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786345|NCT04066491|BG003|Baseline|Total|Total of all reporting groups
10786346|NCT04066491|FG000|Participant Flow|Safety Run-In Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-specified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m^2) and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
10786347|NCT04066491|FG001|Participant Flow|Double-blinded Part: Placebo + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786348|NCT04066491|FG002|Participant Flow|Double-blinded Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786349|NCT04066491|OG000|Outcome|Safety Run-In Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-specified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
10786350|NCT04066491|OG000|Outcome|Double-blinded Part: Placebo + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786351|NCT04066491|OG001|Outcome|Double-blinded Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
11241049|NCT02484651|BG001|Baseline|Deep NMB Group|"Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).~Sugammadex: Reversal of deep neuromuscular block~Rocuronium: Maintenance of deep neuromuscular block"
10802141|NCT02643420|OG001|Outcome|Arm 2: Pegfilgrastim and TC -Treatment Period|Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
10786352|NCT04066491|OG000|Outcome|Safety Run-In Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-specified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786353|NCT04066491|EG000|Reported Event|Safety Run-In Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-specified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m^2) and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
10786354|NCT04066491|EG001|Reported Event|Double-blinded Part: Placebo + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786355|NCT04066491|EG002|Reported Event|Double-blinded Part: M7824 + Gemcitabine + Cisplatin|Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 mg/m^2 and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks. In case of any missed dose for chemotherapy, gemcitabine and cisplatin combination administered on Day 15 of that cycle or at the end of the scheduled 8 cycles (up to 16 administrations of gemcitabine and cisplatin combination). The administration of the missed dose on Day 15 or at the end of 8 cycles is Investigator's clinical decision.
10786356|NCT03259425|BG000|Baseline|Nivolumab and HF10 (All Participants )|"Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.~HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections."
10786357|NCT03259425|FG000|Participant Flow|Nivolumab and HF10 (All Participants)|"Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.~HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections."
10786358|NCT03259425|OG000|Outcome|Nivolumab and HF10 (All Participants)|"Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.~HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections."
10786359|NCT03259425|EG000|Reported Event|Nivolumab and HF10 (All Participants)|"Nivolumab: Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.~HF10: 1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections."
10786360|NCT03129100|BG000|Baseline|IXE80Q4W-Group A Extension Period|Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) for up to week 24.
10786361|NCT03129100|BG001|Baseline|IXE80Q2W-Group A Extension Period|Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
10786362|NCT03129100|BG002|Baseline|IXE80Q4W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
11382248|NCT01708954|OG002|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786363|NCT03129100|BG003|Baseline|IXE80Q2W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
10786364|NCT03129100|BG004|Baseline|Placebo-Group B-Randomized Withdrawal Extension Period|Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
10786365|NCT03129100|BG005|Baseline|Total|Total of all reporting groups
10786366|NCT03129100|FG000|Participant Flow|IXE 80Q4W-Lead-in Period|Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.
10786367|NCT03129100|FG001|Participant Flow|IXE80Q2W-Lead-in Period|Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
10786368|NCT03129100|FG002|Participant Flow|IXE80Q4W-Group A Extension Period|Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.
11241050|NCT02484651|BG002|Baseline|Total|Total of all reporting groups
11382249|NCT01708954|EG000|Reported Event|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786369|NCT03129100|FG003|Participant Flow|IXE80Q2W-Group A Extension Period|Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.
10786370|NCT03129100|FG004|Participant Flow|IXE80Q4W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
10786371|NCT03129100|FG005|Participant Flow|IXE80Q2W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
10786372|NCT03129100|FG006|Participant Flow|Placebo-Group B-Randomized Withdrawal Extension Period|Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
10786373|NCT03129100|FG007|Participant Flow|IXE80Q2W/IXE80Q2W-Retreatment Extension Period|Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
10786374|NCT03129100|FG008|Participant Flow|IXE80Q4W/IXE80Q4W-Retreatment Extension Period|Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786375|NCT03129100|FG009|Participant Flow|PBO/IXE80Q2W-Retreatment Extension Period|Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
10786376|NCT03129100|FG010|Participant Flow|PBO/IXE80Q4W-Retreatment Extension Period|Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786377|NCT03129100|FG011|Participant Flow|IXE80Q2W-group A Long-term Extension Period|"Participants from IXE80Q2W group A extension period continued to receive same treatment that they were receiving at the end of Period 2."
10786378|NCT03129100|FG012|Participant Flow|IXE80Q4W-group A Long-term Extension Period|"Participants from IXE80Q4W group A extension period continued to receive same treatment that they were receiving at the end of Period 2."
10786379|NCT03129100|FG013|Participant Flow|IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from IXE80Q2W-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
11194634|NCT02153359|OG000|Outcome|Air Cleaner|"A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation.~High Efficiency Particulate Air Cleaner"
10786380|NCT03129100|FG014|Participant Flow|IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from IXE80Q4W-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
10786381|NCT03129100|FG015|Participant Flow|PBO-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from Placebo-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
10786382|NCT03129100|FG016|Participant Flow|IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period|Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
10786383|NCT03129100|FG017|Participant Flow|IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period|Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
11241051|NCT02484651|FG000|Participant Flow|Standard Group|Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.
10786384|NCT03129100|FG018|Participant Flow|PBO/IXE80Q2W-Retreatment Long-term Extension Period|Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
10786385|NCT03129100|FG019|Participant Flow|PBO/IXE80Q4W-Retreatment Long-term Extension Period|Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786386|NCT03129100|FG020|Participant Flow|IXE80Q4W-Group A-Escalation Period|Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.
10786387|NCT03129100|FG021|Participant Flow|IXE80Q4W-Randomized Withdrawal Escalation Period|Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.
10786388|NCT03129100|FG022|Participant Flow|PBO-Randomized Withdrawal Escalation Period|Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
10786389|NCT03129100|FG023|Participant Flow|PBO-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786390|NCT03129100|FG024|Participant Flow|IXE80Q4W-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786391|NCT03129100|FG025|Participant Flow|IXE80Q2W-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786392|NCT03129100|OG000|Outcome|Combined IXE|Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.
10786393|NCT03129100|OG001|Outcome|Placebo|Participants received placebo subcutaneously during the randomized withdrawal extension period.
10964737|NCT00878826|EG001|Reported Event|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
10786394|NCT03129100|OG000|Outcome|IXE80Q4W|Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
10786395|NCT03129100|OG001|Outcome|IXE80Q2W|Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
10786396|NCT03129100|OG002|Outcome|Placebo|Participants received placebo subcutaneously during the randomized withdrawal extension period.
10786397|NCT03129100|OG000|Outcome|IXE80Q4W|Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W).
10786398|NCT03129100|OG001|Outcome|IXE80Q2W|Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W).
10786399|NCT03129100|OG002|Outcome|Combined IXE|Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and two weeks (Q2W).
10786400|NCT03129100|OG001|Outcome|IXE80Q2W|Participants received 80 mg of Ixekizumab subcutaneously (SC) every two weeks (Q2W) during the randomized withdrawal extension period.
10786401|NCT03129100|EG000|Reported Event|IXE 80Q4W-Lead-in Period|Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.
10786402|NCT03129100|EG001|Reported Event|IXE80Q2W-Lead-in Period|Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
10786403|NCT03129100|EG002|Reported Event|IXE80Q4W-Group A Extension Period|Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.
10786404|NCT03129100|EG003|Reported Event|IXE80Q2W-Group A Extension Period|Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.
10786405|NCT03129100|EG004|Reported Event|IXE80Q4W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
10786406|NCT03129100|EG005|Reported Event|IXE80Q2W-Group B-Randomized Withdrawal Extension Period|Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
10786407|NCT03129100|EG006|Reported Event|Placebo-Group B-Randomized Withdrawal Extension Period|Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
10786408|NCT03129100|EG007|Reported Event|IXE80Q2W/IXE80Q2W-Retreatment Extension Period|Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
10786409|NCT03129100|EG008|Reported Event|IXE80Q4W/IXE80Q4W-Retreatment Extension Period|Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786410|NCT03129100|EG009|Reported Event|PBO/IXE80Q2W-Retreatment Extension Period|Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
10786411|NCT03129100|EG010|Reported Event|PBO/IXE80Q4W-Retreatment Extension Period|Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786412|NCT03129100|EG011|Reported Event|IXE80Q2W-group A Long-term Extension Period|"Participants from IXE80Q2W group A extension period continued to receive same treatment that they were receiving at the end of Period 2."
10786413|NCT03129100|EG012|Reported Event|IXE80Q4W-group A Long-term Extension Period|"Participants from IXE80Q4W group A extension period continued to receive same treatment that they were receiving at the end of Period 2."
10786414|NCT03129100|EG013|Reported Event|IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from IXE80Q2W-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
10786415|NCT03129100|EG014|Reported Event|IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from IXE80Q4W-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
10786416|NCT03129100|EG015|Reported Event|PBO-Group B-Randomized Withdrawal Long-term Extension Period|"Participants from Placebo-Group B-Randomized Withdrawal Extension Period continued to receive same treatment that they were receiving at the end of Period 2."
10786417|NCT03129100|EG016|Reported Event|IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period|Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
10786418|NCT03129100|EG017|Reported Event|IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period|Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786419|NCT03129100|EG018|Reported Event|PBO/IXE80Q2W-Retreatment Long-term Extension Period|Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
10786420|NCT03129100|EG019|Reported Event|PBO/IXE80Q4W-Retreatment Long-term Extension Period|Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
10786421|NCT03129100|EG020|Reported Event|IXE80Q4W-Group A-Escalation Period|Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.
10786422|NCT03129100|EG021|Reported Event|IXE80Q4W-Randomized Withdrawal Escalation Period|Participants in Group B receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.
10786423|NCT03129100|EG022|Reported Event|PBO-randomized Withdrawal Escalation Period|Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
10786424|NCT03129100|EG023|Reported Event|PBO-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786425|NCT03129100|EG024|Reported Event|IXE80Q4W-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786426|NCT03129100|EG025|Reported Event|IXE80Q2W-follow-up Period|Participants did not receive any intervention during Follow-up period.
10786427|NCT02921763|BG000|Baseline|Dydrogesterone|"Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.~Dydrogesterone"
10786428|NCT02921763|FG000|Participant Flow|Dydrogesterone|"Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.~Dydrogesterone"
10786429|NCT02921763|OG000|Outcome|Dydrogesterone|"Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.~Dydrogesterone"
10786430|NCT02921763|OG000|Outcome|Cycle 3|2 Cycles of dydrogesterone treatment completed
10786431|NCT02921763|OG001|Outcome|Cycle 5|4 Cycles of dydrogesterone treatment completed (at the completion of the observation period)
10786432|NCT02921763|OG000|Outcome|Cycle -1|Before treatment initiation (Baseline)
10786433|NCT02921763|OG001|Outcome|Cycle 1|At treatment initiation (the administration could be started during menstruation of cycle 1)
10786434|NCT02921763|OG002|Outcome|Cycle 2|1 Cycles of dydrogesterone treatment completed
10786435|NCT02921763|OG003|Outcome|Cycle 3|2 Cycles of dydrogesterone treatment completed
10786436|NCT02921763|OG004|Outcome|Cycle 4|3 Cycles of dydrogesterone treatment completed
10786437|NCT02921763|OG005|Outcome|Cycle 5|4 Cycles of dydrogesterone treatment completed (at the completion of the observation period)
10786438|NCT02921763|OG000|Outcome|Cycle 1|At treatment initiation (the administration could be started during menstruation of cycle 1)
10786439|NCT02921763|OG001|Outcome|Cycle 2|1 Cycles of dydrogesterone treatment completed
10786440|NCT02921763|OG002|Outcome|Cycle 3|2 Cycles of dydrogesterone treatment completed
10786441|NCT02921763|OG003|Outcome|Cycle 4|3 Cycles of dydrogesterone treatment completed
10786442|NCT02921763|OG004|Outcome|Cycle 5|4 Cycles of dydrogesterone treatment completed (at the completion of the observation period)
10786443|NCT02921763|OG000|Outcome|Cycle 5|4 Cycles of dydrogesterone treatment completed (at the completion of the observation period)
10786444|NCT02921763|EG000|Reported Event|Dydrogesterone|"Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.~Of 60 subjects whose case report forms were collected, 59 subjects were included in the safety analysis set, after excluding one subject (reason: one subject, no data entered)."
10786445|NCT02831257|BG000|Baseline|AZD2014|"18 patients will be enrolled in this study in a single stage.~AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days.~One cycle will consist of 28 days (1 cycle = 28 days)."
10786446|NCT02831257|FG000|Participant Flow|AZD2014|"18 patients will be enrolled in this study in a single stage.~AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days.~One cycle will consist of 28 days (1 cycle = 28 days)."
10786447|NCT02831257|OG000|Outcome|AZD2014|"18 patients will be enrolled in this study in a single stage.~AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days.~One cycle will consist of 28 days (1 cycle = 28 days)."
10786448|NCT02831257|EG000|Reported Event|AZD2014|"18 patients will be enrolled in this study in a single stage.~AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days.~One cycle will consist of 28 days (1 cycle = 28 days)."
10786449|NCT02775903|BG000|Baseline|MDS: Azacitidine + Durvalumab|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786450|NCT02775903|BG001|Baseline|MDS: Azacitidine Alone|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786451|NCT02775903|BG002|Baseline|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786452|NCT02775903|BG003|Baseline|AML: Azacitidine Alone|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786453|NCT02775903|BG004|Baseline|Total|Total of all reporting groups
10786454|NCT02775903|FG000|Participant Flow|MDS: Azacitidine + Durvalumab|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786455|NCT02775903|FG001|Participant Flow|MDS: Azacitidine Alone|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10802142|NCT02643420|OG002|Outcome|Arm 1: SPI-2012 and TC - Follow up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
10964738|NCT00878826|EG002|Reported Event|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
10786456|NCT02775903|FG002|Participant Flow|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786457|NCT02775903|FG003|Participant Flow|AML: Azacitidine Alone|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786458|NCT02775903|OG000|Outcome|MDS: Azacitidine + Durvalumab|Participants with MDS received 75 mg/m² subcutaneous azacitidine (AZA) for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab (DUR) on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786459|NCT02775903|OG001|Outcome|MDS: Azacitidine Alone|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786460|NCT02775903|OG000|Outcome|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786461|NCT02775903|OG001|Outcome|AML: Azacitidine Alone|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786462|NCT02775903|OG000|Outcome|MDS: Azacitidine + Durvalumab|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786463|NCT02775903|OG002|Outcome|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786464|NCT02775903|OG003|Outcome|AML: Azacitidine Alone|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786465|NCT02775903|OG001|Outcome|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786466|NCT02775903|EG000|Reported Event|MDS: Azacitidine + Durvalumab|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786467|NCT02775903|EG001|Reported Event|MDS: Azacitidine Alone|Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786468|NCT02775903|EG002|Reported Event|AML: Azacitidine + Durvalumab|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786469|NCT02775903|EG003|Reported Event|AML: Azacitidine Alone|Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
10786470|NCT02476916|BG000|Baseline|AG-348 50 mg BID|Participants with PK deficiency received AG-348, 50 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786471|NCT02476916|BG001|Baseline|AG-348 300 mg BID|Participants with PK deficiency received AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786472|NCT02476916|BG002|Baseline|Total|Total of all reporting groups
10802143|NCT02643420|OG003|Outcome|Arm 2: Pegfilgrastim and TC - Follow up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
10786473|NCT02476916|FG000|Participant Flow|AG-348 50 mg BID|Participants with Pyruvate Kinase (PK) deficiency received AG-348, 50 milligrams (mg), as initial dose, twice daily (BID) for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent adverse events (AEs) and hemoglobin (Hb) levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786474|NCT02476916|FG001|Participant Flow|AG-348 300 mg BID|Participants with PK deficiency received AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786475|NCT02476916|OG000|Outcome|AG-348 50 mg BID|Participants with PK deficiency received AG-348, 50 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786476|NCT02476916|OG001|Outcome|AG-348 300 mg BID|Participants with PK deficiency received AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786477|NCT02476916|OG001|Outcome|AG-348 300 mg|Participants with PK deficiency received AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786478|NCT02476916|EG000|Reported Event|AG-348 50 mg BID|Participants with PK deficiency received AG-348, 50 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786479|NCT02476916|EG001|Reported Event|AG-348 300 mg BID|Participants with PK deficiency received AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants were assigned to initial doses, however, over the course of the Core Period were treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. If participants chose not to enroll, they were followed up to four weeks after the last dose of AG-348.
10786480|NCT02406027|BG000|Baseline|Double-blind Treatment Phase (Period 1): Placebo|Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786481|NCT02406027|BG001|Baseline|Double-blind Treatment Phase (Period 1): Atabecestat 10 mg|Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786482|NCT02406027|BG002|Baseline|Double-blind Treatment Phase (Period 1): Atabecestat 25 mg|Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786483|NCT02406027|BG003|Baseline|Total|Total of all reporting groups
10786484|NCT02406027|FG000|Participant Flow|Double-blind Treatment Phase (Period 1): Placebo|Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786485|NCT02406027|FG001|Participant Flow|Double-blind Treatment Phase (Period 1): Atabecestat 10 mg|Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786486|NCT02406027|FG002|Participant Flow|Double-blind Treatment Phase (Period 1): Atabecestat 25 mg|Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786487|NCT02406027|FG003|Participant Flow|Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
11241052|NCT02484651|FG001|Participant Flow|Deep NMB Group|"Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).~Sugammadex: Reversal of deep neuromuscular block~Rocuronium: Maintenance of deep neuromuscular block"
10786488|NCT02406027|FG004|Participant Flow|OL Phase (Period 2): Placebo to Atabecestat 25 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786489|NCT02406027|FG005|Participant Flow|OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg|Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786490|NCT02406027|FG006|Participant Flow|OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg|Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786491|NCT02406027|OG000|Outcome|Double-blind Treatment Phase (Period 1): Placebo|Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786492|NCT02406027|OG001|Outcome|Double-blind Treatment Phase (Period 1): Atabecestat 10 mg|Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786493|NCT02406027|OG002|Outcome|Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg|Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786494|NCT02406027|OG003|Outcome|Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786495|NCT02406027|OG004|Outcome|OL Phase (Period 2): Placebo to Atabecestat 25 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786496|NCT02406027|OG005|Outcome|OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg|Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786497|NCT02406027|OG006|Outcome|OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg|Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786498|NCT02406027|EG000|Reported Event|Double-blind Treatment Phase (Period 1): Placebo|Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
11241053|NCT02484651|OG000|Outcome|Standard Group|Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.
10786499|NCT02406027|EG001|Reported Event|Double-blind Treatment Phase (Period 1): Atabecestat 10 mg|Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786500|NCT02406027|EG002|Reported Event|Double-blind Treatment Phase (Period 1): Atabecestat 25 mg|Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.
10786501|NCT02406027|EG003|Reported Event|Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786502|NCT02406027|EG004|Reported Event|OL Phase (Period 2): Placebo to Atabecestat 25 mg|Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786503|NCT02406027|EG005|Reported Event|OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg|Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786504|NCT02406027|EG006|Reported Event|OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg|Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.
10786505|NCT02374814|BG000|Baseline|Rabies Vaccine IM 3 Dose|"This is standard FDA approved schedule~Rabies vaccine: Compare dose schedule and route of administration"
10786506|NCT02374814|BG001|Baseline|Rabies Vaccine ID 3 Dose|"This is using alternative administration method~Rabies vaccine: Compare dose schedule and route of administration"
10786507|NCT02374814|BG002|Baseline|Rabies Vaccine IM 2 Dose|"This is using alternative dose schedule~Rabies vaccine: Compare dose schedule and route of administration"
10786508|NCT02374814|BG003|Baseline|Rabies Vaccine ID 2 Dose|"This is using alternative dose schedule and administration~Rabies vaccine: Compare dose schedule and route of administration"
10786509|NCT02374814|BG004|Baseline|Placebo IM 1 Dose|"Albumin and saline comparator~Placebo: Placebo"
10786510|NCT02374814|BG005|Baseline|Placebo ID 1 Dose|"Albumin and saline comparator~Placebo: Placebo"
10786511|NCT02374814|BG006|Baseline|Total|Total of all reporting groups
10786512|NCT02374814|FG000|Participant Flow|Rabies Vaccine IM 3 Dose|Rabies vaccine: 1.0 ml delivered Intramuscularly (IM) on day 0, 7, 21 and 365.
10786513|NCT02374814|FG001|Participant Flow|Rabies Vaccine ID 3 Dose|Rabies vaccine: 0.1 ml of rabies vaccine delivered intradermal (ID) on days 0, 7, and 21 with a 1.0ml boost delivered IM on day 365.
10786514|NCT02374814|FG002|Participant Flow|Rabies Vaccine IM 2 Dose|Rabies vaccine: 1.0ml delivered IM on day 0, 7 and 365.
10786515|NCT02374814|FG003|Participant Flow|Rabies Vaccine ID 2 Dose|Rabies vaccine: 0.1ml delivered on day 0 and 7 with a 1.0ml IM boost on day 365
10786516|NCT02374814|FG004|Participant Flow|Placebo IM 1 Dose|Placebo: 1.0ml delivered IM on day 0
10786517|NCT02374814|FG005|Participant Flow|Placebo ID 1 Dose|Placebo: 0.1ml delivered on day 0
10786518|NCT02374814|OG000|Outcome|Rabies Vaccine IM 3 Dose|"Rabies vaccine:~Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365."
11382250|NCT01708954|EG001|Reported Event|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786519|NCT02374814|OG001|Outcome|Rabies Vaccine ID 3 Dose|"Rabies vaccine:~Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365."
10786520|NCT02374814|OG002|Outcome|Rabies Vaccine IM 2 Dose|"Rabies vaccine:~Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365."
10786521|NCT02374814|OG003|Outcome|Rabies Vaccine ID 2 Dose|"Rabies vaccine:~Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365."
10786522|NCT02374814|OG004|Outcome|Placebo IM 1 Dose|"Albumin and saline comparator~Placebo: A single 1mL intramuscular injection at day 0"
10786523|NCT02374814|OG005|Outcome|Placebo ID 1 Dose|"Albumin and saline comparator~Placebo: A single intradermal injection of 0.1mL at day 0"
10786524|NCT02374814|OG000|Outcome|Rabies Vaccine IM 3 Dose|Rabies vaccine: Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365.
10786525|NCT02374814|OG001|Outcome|Rabies Vaccine ID 3 Dose|Rabies vaccine: Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365.
10786526|NCT02374814|OG002|Outcome|Rabies Vaccine IM 2 Dose|Rabies vaccine: Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365.
10786527|NCT02374814|OG003|Outcome|Rabies Vaccine ID 2 Dose|Rabies vaccine: Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365.
10786528|NCT02374814|OG005|Outcome|Placebo ID 1 Dose|"Albumin and saline comparator~Placebo: A single 0.1mL intradermal injection at day 0"
10786529|NCT02374814|OG002|Outcome|Rabies Vaccine IM 2 Dose|"Rabies vaccine:~Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365"
11194635|NCT02153359|OG001|Outcome|Sham Air Cleaner|"A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation.~Sham air cleaner"
10786530|NCT02374814|OG004|Outcome|Placebo IM 1 Dose|"Albumin and saline comparator~Placebo: 1mL intramuscular at day 0"
10786531|NCT02374814|OG005|Outcome|Placebo ID 1 Dose|"Albumin and saline comparator~Placebo: 0.1 mL intradermal at day 0"
10786532|NCT02374814|EG000|Reported Event|Rabies Vaccine IM 3 Dose|Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365
10786533|NCT02374814|EG001|Reported Event|Rabies Vaccine ID 3 Dose|Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365
10786534|NCT02374814|EG002|Reported Event|Rabies Vaccine IM 2 Dose|Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365
10786535|NCT02374814|EG003|Reported Event|Rabies Vaccine ID 2 Dose|Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365
10786536|NCT02374814|EG004|Reported Event|Placebo IM 1 Dose|"Albumin and saline comparator~Intramuscular injection: 1ml"
10786537|NCT02374814|EG005|Reported Event|Placebo ID 1 Dose|"Albumin and saline comparator~Intradermal injection: 0.1ml"
10786538|NCT02142738|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
10786539|NCT02142738|BG001|Baseline|SOC Chemotherapy|Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
10786540|NCT02142738|BG002|Baseline|Total|Total of all reporting groups
10786541|NCT02142738|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
10786542|NCT02142738|FG001|Participant Flow|SOC Chemotherapy|Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
10786543|NCT02142738|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
10803766|NCT02134028|OG007|Outcome|Participants From PDY14192: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10786544|NCT02142738|OG001|Outcome|SOC Chemotherapy|Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
10786545|NCT02142738|EG000|Reported Event|Pembrolizumab First Course|Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
10786546|NCT02142738|EG001|Reported Event|SOC Chemotherapy First Course|Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
10786547|NCT02142738|EG002|Reported Event|SOC Chemotherapy Switched Over to Pembrolizumab First Course|Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to ~2 years.
10786548|NCT02142738|EG003|Reported Event|Pembrolizumab Second Course|Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).
10786549|NCT02142738|EG004|Reported Event|SOC Switched Over to Pembrolizumab Second Course|One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to ~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year until documented PD or participant discontinuation.
10786550|NCT02032823|BG000|Baseline|Olaparib|Olaparib tablets 300mg taken orally twice daily.
10786551|NCT02032823|BG001|Baseline|Placebo|Placebo tablets taken orally twice daily.
10786552|NCT02032823|BG002|Baseline|Total|Total of all reporting groups
10786553|NCT02032823|FG000|Participant Flow|Olaparib|Olaparib tablets 300mg taken orally twice daily.
11194636|NCT02153359|OG001|Outcome|Sham Air Cleaner|A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, which include in-home health questionnaires, symptom-, and activity- diaries/recalls, blood, and hand-held spirometry. Participants will also be asked to wear a light backpack with air monitoring devices during the course of the day during the last week in order to measure participants' exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which airway sampling will occur under conscious sedation. For the participants who started in the experimental arm, after this one month intervention period, they will then enter a wash-out period where no intervention or outcome measures are undertaken for at least one month prior to cross-over to the sham comparator arm.
11194637|NCT02153359|EG000|Reported Event|Air Cleaner|A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which nasal and lower airway sampling will occur under conscious sedation.
11194638|NCT02153359|EG001|Reported Event|Sham Air Cleaner|A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which nasal and lower airway sampling will occur under conscious sedation.
10786554|NCT02032823|FG001|Participant Flow|Placebo|Placebo tablets taken orally twice daily.
10786555|NCT02032823|OG000|Outcome|Olaparib|Olaparib tablets 300mg taken orally twice daily.
10786556|NCT02032823|OG001|Outcome|Placebo|Placebo tablets taken orally twice daily.
10786557|NCT02032823|EG000|Reported Event|Olaparib|Olaparib tablets 300mg taken orally twice daily.
10786558|NCT02032823|EG001|Reported Event|Placebo|Placebo tablets taken orally twice daily.
10786559|NCT02005172|BG000|Baseline|Pre-Protocol (PP) Group|This group includes all patients who completed and complied with the study protocol (per-protocol [PP] sample).
10786560|NCT02005172|FG000|Participant Flow|Per-Protocol (PP) Group|This group includes all patients who completed and complied with the study protocol (per-protocol [PP] sample). These patients completed monitoring with both the Alivecor device (experimental) and external loop recorder (standard of care).
10786561|NCT02005172|OG000|Outcome|Kardia Mobile (AliveCor Device)|AliveCor (Kardia Mobile ) used for 14 days
10786562|NCT02005172|OG001|Outcome|External Loop Recorder (ELR/ Event Monitor)|Event monitor or ELR used for 14 days
11194639|NCT02153398|BG000|Baseline|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
11194640|NCT02153398|BG001|Baseline|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
11194641|NCT02153398|BG002|Baseline|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
11194642|NCT02153398|BG003|Baseline|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
11194643|NCT02153398|BG004|Baseline|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
11194644|NCT02153398|BG005|Baseline|Total|Total of all reporting groups
11194645|NCT02153398|FG000|Participant Flow|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
11194646|NCT02153398|FG001|Participant Flow|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
11194647|NCT02153398|FG002|Participant Flow|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
11194648|NCT02153398|FG003|Participant Flow|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
11194649|NCT02153398|FG004|Participant Flow|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
11194650|NCT02153398|OG000|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
11194651|NCT02153398|OG001|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
11194652|NCT02153398|OG002|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
11194653|NCT02153398|OG003|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
11194654|NCT02153398|OG004|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
11194655|NCT02153398|EG000|Reported Event|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
10786563|NCT02005172|EG000|Reported Event|Alivecor Device and Event Monitor|"Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study~Alivecor monitor and 14 day event monitor: Alivecor monitor and 14 day event monitor"
10786564|NCT01931709|BG000|Baseline|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
10786565|NCT01931709|FG000|Participant Flow|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
10786566|NCT01931709|OG000|Outcome|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
10964739|NCT00878878|BG000|Baseline|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
11194656|NCT02153398|EG001|Reported Event|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
11194657|NCT02153398|EG002|Reported Event|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
11194658|NCT02153398|EG003|Reported Event|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
11194659|NCT02153398|EG004|Reported Event|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
11194660|NCT02153476|BG000|Baseline|2.0mg of ALG-1001|"2.0mg of ALG-1001~2.0mg of ALG-1001"
11194661|NCT02153476|BG001|Baseline|Intravitreal Injection in 0.05cc BSS|"Balanced Salt Solution~Balanced Salt Solution"
11194662|NCT02153476|BG002|Baseline|Total|Total of all reporting groups
11194663|NCT02153476|FG000|Participant Flow|2.0mg of ALG-1001|"2.0mg of ALG-1001~2.0mg of ALG-1001"
11194664|NCT02153476|FG001|Participant Flow|Intravitreal Injection in 0.05cc BSS|"Balanced Salt Solution~Balanced Salt Solution"
11194665|NCT02153476|OG000|Outcome|2.0mg of ALG-1001|"2.0mg of ALG-1001~2.0mg of ALG-1001"
11194666|NCT02153476|OG001|Outcome|Intravitreal Injection in 0.05cc BSS|"Balanced Salt Solution~Balanced Salt Solution"
11194667|NCT02153476|EG000|Reported Event|2.0mg of ALG-1001|"2.0mg of ALG-1001~2.0mg of ALG-1001"
11194668|NCT02153476|EG001|Reported Event|Intravitreal Injection in 0.05cc BSS|"Balanced Salt Solution~Balanced Salt Solution"
11194669|NCT02153489|BG000|Baseline|Overall Study|All patients participating in the crossover study
11194670|NCT02153489|FG000|Participant Flow|Sequence A|Aclidinium 400 μg - Placebo
11194671|NCT02153489|FG001|Participant Flow|Sequence B|Placebo - Aclidinium 400 μg
11194672|NCT02153489|OG000|Outcome|Aclidinium|Aclidinium 400 μg BID
11194673|NCT02153489|OG001|Outcome|Placebo|Placebo BID
11194674|NCT02153489|EG000|Reported Event|Aclidinium|Aclidinium 400 μg BID
11194675|NCT02153489|EG001|Reported Event|Placebo|Placebo BID
11194676|NCT02153528|BG000|Baseline|Standard TB Treatment|"Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease~Standard TB treatment: Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease"
10786567|NCT01931709|OG000|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
10786568|NCT01931709|OG001|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
10786569|NCT01931709|EG000|Reported Event|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
10786570|NCT01667133|BG000|Baseline|Ponatinib 30 mg: Phase 1 CP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786571|NCT01667133|BG001|Baseline|Ponatinib 30 mg: Phase 1 AP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786572|NCT01667133|BG002|Baseline|Ponatinib 30 mg: Phase 1 Ph+ ALL|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786573|NCT01667133|BG003|Baseline|Ponatinib 45 mg: Phase 1 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786574|NCT01667133|BG004|Baseline|Ponatinib 45 mg: Phase 1 AP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786575|NCT01667133|BG005|Baseline|Ponatinib 45 mg: Phase 1 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786576|NCT01667133|BG006|Baseline|Ponatinib 45 mg: Phase 1 Ph+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786577|NCT01667133|BG007|Baseline|Ponatinib 15 mg: Phase 2 CP-CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786578|NCT01667133|BG008|Baseline|Ponatinib 15 mg: Phase 2 Ph+ ALL|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
10786579|NCT01667133|BG009|Baseline|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786580|NCT01667133|BG010|Baseline|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786581|NCT01667133|BG011|Baseline|Ponatinib 45 mg: Phase 2 PH+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
10786582|NCT01667133|BG012|Baseline|Total|Total of all reporting groups
10786583|NCT01667133|FG000|Participant Flow|Ponatinib 30 mg: Phase 1 CP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with chronic phase (CP)-chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786584|NCT01667133|FG001|Participant Flow|Ponatinib 30 mg: Phase 1 AP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with accelerated phase (AP)- CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786585|NCT01667133|FG002|Participant Flow|Ponatinib 30 mg: Phase 1 Ph+ ALL|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Philadelphia chromosome plus acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior tyrosine kinase inhibitor (TKIs) in Dose-escalation Phase 1.
10786586|NCT01667133|FG003|Participant Flow|Ponatinib 45 mg: Phase 1 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
11382251|NCT01708954|EG002|Reported Event|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10786587|NCT01667133|FG004|Participant Flow|Ponatinib 45 mg: Phase 1 AP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786588|NCT01667133|FG005|Participant Flow|Ponatinib 45 mg: Phase 1 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786589|NCT01667133|FG006|Participant Flow|Ponatinib 45 mg: Phase 1 Ph+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786590|NCT01667133|FG007|Participant Flow|Ponatinib 15 mg: Phase 2 CP- CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786591|NCT01667133|FG008|Participant Flow|Ponatinib 15 mg: Phase 2 Ph+ ALL|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
10786592|NCT01667133|FG009|Participant Flow|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786593|NCT01667133|FG010|Participant Flow|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786594|NCT01667133|FG011|Participant Flow|Ponatinib 45 mg: Phase 2 PH+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
10786595|NCT01667133|OG000|Outcome|Ponatinib 30 mg: Phase 1 CP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786596|NCT01667133|OG001|Outcome|Ponatinib 30 mg: Phase 1 AP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786597|NCT01667133|OG002|Outcome|Ponatinib 30 mg: Phase 1 Ph+ ALL|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786598|NCT01667133|OG003|Outcome|Ponatinib 45 mg: Phase 1 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786599|NCT01667133|OG004|Outcome|Ponatinib 45 mg: Phase 1 AP CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786600|NCT01667133|OG005|Outcome|Ponatinib 45 mg: Phase 1 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786601|NCT01667133|OG006|Outcome|Ponatinib 45 mg: Phase 1 Ph+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786602|NCT01667133|OG000|Outcome|Ponatinib 15 mg: Phase 2 CP-CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786603|NCT01667133|OG001|Outcome|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786604|NCT01667133|OG000|Outcome|Ponatinib 15 mg: Phase 2 Ph+ ALL|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
10786605|NCT01667133|OG001|Outcome|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786606|NCT01667133|OG002|Outcome|Ponatinib 45 mg: Phase 2 PH+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
10786607|NCT01667133|OG001|Outcome|Ponatinib 45 mg: Phase 1 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786608|NCT01667133|OG002|Outcome|Ponatinib 15 mg: Phase 2 CP-CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786609|NCT01667133|OG003|Outcome|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786610|NCT01667133|OG004|Outcome|Ponatinib 45 mg: Phase 1 AP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786611|NCT01667133|OG006|Outcome|Ponatinib 45 mg: Phase 1 Ph+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786612|NCT01667133|OG007|Outcome|Ponatinib 15 mg: Phase 2 CP-CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786613|NCT01667133|OG008|Outcome|Ponatinib 15 mg: Phase 2 Ph+ ALL|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
10786614|NCT01667133|OG009|Outcome|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786615|NCT01667133|OG010|Outcome|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 6 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786616|NCT01667133|OG011|Outcome|Ponatinib 45 mg: Phase 2 PH+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
10786617|NCT01667133|OG010|Outcome|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786618|NCT01667133|OG000|Outcome|Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had (T)hreonine-315-(I)soleucine mutation (T315I) mutation of BCR-ABL in Dose-escalation Phase 1.
10786619|NCT01667133|OG001|Outcome|Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
10786620|NCT01667133|OG002|Outcome|Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786621|NCT01667133|OG003|Outcome|Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.
10786622|NCT01667133|OG004|Outcome|Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
10786623|NCT01667133|OG005|Outcome|Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
10786624|NCT01667133|OG006|Outcome|Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786625|NCT01667133|OG007|Outcome|Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
10964740|NCT00878878|BG001|Baseline|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
10964741|NCT00878878|BG002|Baseline|Total|Total of all reporting groups
10964742|NCT00878878|FG000|Participant Flow|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
11382252|NCT01708954|EG003|Reported Event|Arm Z (Erlotinib+Cabozantinib; Step 2)|Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11382253|NCT01708941|BG000|Baseline|Arm A (Higher Dose Ipilimumab, HDI)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382254|NCT01708941|BG001|Baseline|Arm B (Higher Dose Ipilimumab)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382255|NCT01708941|BG002|Baseline|Arm C (Lower Dose Ipilimumab + HDI)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382256|NCT01708941|BG003|Baseline|Arm D (Lower Dose Ipilimumab)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382257|NCT01708941|BG004|Baseline|Total|Total of all reporting groups
11382258|NCT01708941|FG000|Participant Flow|Arm A (Higher Dose Ipilimumab, HDI)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382259|NCT01708941|FG001|Participant Flow|Arm B (Higher Dose Ipilimumab)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382260|NCT01708941|FG002|Participant Flow|Arm C (Lower Dose Ipilimumab + HDI)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382261|NCT01708941|FG003|Participant Flow|Arm D (Lower Dose Ipilimumab)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382262|NCT01708941|OG000|Outcome|Ipilimumab + HDI|"INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382263|NCT01708941|OG001|Outcome|Ipilimumab Alone|"INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382264|NCT01708941|OG000|Outcome|Higher Dose Ipilimumab (With or Without HDI)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382265|NCT01708941|OG001|Outcome|Lower Dose Ipilimumab (With or Without HDI)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
10786626|NCT01667133|OG008|Outcome|Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
10786627|NCT01667133|OG009|Outcome|Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
10786628|NCT01667133|OG010|Outcome|Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations|Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
10786629|NCT01667133|OG011|Outcome|Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
10786630|NCT01667133|OG012|Outcome|Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
10786631|NCT01667133|OG013|Outcome|Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
10786632|NCT01667133|OG014|Outcome|Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations|Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
10786633|NCT01667133|OG015|Outcome|Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
10786634|NCT01667133|OG000|Outcome|Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
10786635|NCT01667133|OG002|Outcome|Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786636|NCT01667133|OG015|Outcome|Phase 2: Ponatinib 45 mg, Advanced Phase Participants With Other Mutations|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
10786637|NCT01667133|OG008|Outcome|Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
10786638|NCT01667133|OG000|Outcome|Ponatinib 15 mg|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
10786639|NCT01667133|OG001|Outcome|Ponatinib 30 mg|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
10786640|NCT01667133|OG002|Outcome|Ponatinib 45 mg|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
10786641|NCT01667133|OG000|Outcome|Ponatinib 15 mg|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
11194677|NCT02153528|BG001|Baseline|Double Rimfampicin|"2HREZ/4HR Cat. 1, modified by using double dose rifampicin throughout~double rimfampicin: Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained"
11194678|NCT02153528|BG002|Baseline|Total|Total of all reporting groups
10786642|NCT01667133|EG000|Reported Event|Ponatinib 30 mg: Phase 1 CP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786643|NCT01667133|EG001|Reported Event|Ponatinib 30 mg: Phase 1 AP-CML|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786644|NCT01667133|EG002|Reported Event|Ponatinib 30 mg: Phase 1 Ph+ ALL|Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786645|NCT01667133|EG003|Reported Event|Ponatinib 45 mg: Phase 1 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786646|NCT01667133|EG004|Reported Event|Ponatinib 45 mg: Phase 1 AP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786647|NCT01667133|EG005|Reported Event|Ponatinib 45 mg: Phase 1 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
10786648|NCT01667133|EG006|Reported Event|Ponatinib 45 mg: Phase 1 Ph+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
10786649|NCT01667133|EG007|Reported Event|Ponatinib 15 mg: Phase 2 CP-CML|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
10786650|NCT01667133|EG008|Reported Event|Ponatinib 15 mg: Phase 2 Ph+ ALL|Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
10786651|NCT01667133|EG009|Reported Event|Ponatinib 45 mg: Phase 2 CP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786652|NCT01667133|EG010|Reported Event|Ponatinib 45 mg: Phase 2 BP-CML|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
10786653|NCT01667133|EG011|Reported Event|Ponatinib 45 mg: Phase 2 PH+ ALL|Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
10786654|NCT01585103|BG000|Baseline|Cytosponge/ Brushing|"Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.~Cytosponge: An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected."
10786655|NCT01585103|FG000|Participant Flow|Cytosponge/ Brushing|"Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.~Cytosponge: An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected."
11194679|NCT02153528|FG000|Participant Flow|Standard TB Treatment|"Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease~Standard TB treatment: Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease"
11194680|NCT02153528|FG001|Participant Flow|Double Rimfampicin|"2HREZ/4HR Cat. 1, modified by using double dose rifampicin throughout~double rimfampicin: Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained"
10786656|NCT01585103|OG000|Outcome|Cytosponge/ Brushing|"Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.~Cytosponge: An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected."
10802144|NCT02643420|EG000|Reported Event|Arm 1: SPI-2012 and TC -Treatment Period|Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
11382266|NCT01708941|EG000|Reported Event|Arm A (Higher Dose Ipilimumab, HDI)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382267|NCT01708941|EG001|Reported Event|Arm B (Higher Dose Ipilimumab)|"INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382268|NCT01708941|EG002|Reported Event|Arm C (Lower Dose Ipilimumab + HDI)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.~Ipilimumab: Given IV~Recombinant Interferon Alfa-2b: Given IV or SC"
11382269|NCT01708941|EG003|Reported Event|Arm D (Lower Dose Ipilimumab)|"INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.~MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.~Ipilimumab: Given IV"
11382270|NCT01555541|BG000|Baseline|Treatment|"OVA Treatment:~Ofatumumab: 1000 mg IV days 0, 7, 14, 21~Etoposide: 10 mg/Kg IV over 24 hours daily, days 1-4~Cytarabine: 2000 mg/m2 IV twice daily, days 1-4~---------~After Day 42 assessment:~Autologous Transplantation:~Stem Cell Infusion on day 0~BCNU 15 mg/Kg, day -6~Etoposide 60 mg/Kg, day -4~Cyclophosphamide: 100 mg/Kg, day -2"
11382271|NCT01555541|FG000|Participant Flow|Treatment|"OVA Treatment:~Ofatumumab: 1000 mg IV days 0, 7, 14, 21~Etoposide: 10 mg/Kg IV over 24 hours daily, days 1-4~Cytarabine: 2000 mg/m2 IV twice daily, days 1-4~---------~After Day 42 assessment:~Autologous Transplantation:~Stem Cell Infusion on day 0~Carmustine (BCNU) 15 mg/Kg, day -6~Etoposide 60 mg/Kg, day -4~Cyclophosphamide: 100 mg/Kg, day -2"
11382272|NCT01555541|OG000|Outcome|Treatment|"OVA Treatment:~Ofatumumab: 1000 mg IV days 0, 7, 14, 21~Etoposide: 10 mg/Kg IV over 24 hours daily, days 1-4~Cytarabine: 2000 mg/m2 IV twice daily, days 1-4~---------~After Day 42 assessment:~Autologous Transplantation:~Stem Cell Infusion on day 0~BCNU 15 mg/Kg, day -6~Etoposide 60 mg/Kg, day -4~Cyclophosphamide: 100 mg/Kg, day -2"
11382273|NCT01555541|EG000|Reported Event|Treatment|"OVA Treatment:~Ofatumumab: 1000 mg IV days 0, 7, 14, 21~Etoposide: 10 mg/Kg IV over 24 hours daily, days 1-4~Cytarabine: 2000 mg/m2 IV twice daily, days 1-4~---------~After Day 42 assessment:~Autologous Transplantation:~Stem Cell Infusion on day 0~BCNU 15 mg/Kg, day -6~Etoposide 60 mg/Kg, day -4~Cyclophosphamide: 100 mg/Kg, day -2"
11382274|NCT01398852|BG000|Baseline|CXL Treatment|All eyes to be treated with riboflavin and UV light
10964743|NCT00878878|FG001|Participant Flow|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
10964744|NCT00878878|OG000|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
11382275|NCT01398852|FG000|Participant Flow|CXL Treatment|All eyes to be treated with riboflavin and UV light
11382276|NCT01398852|OG000|Outcome|CXL Treatment|All eyes to be treated with riboflavin and UV light
11382277|NCT01398852|EG000|Reported Event|CXL Treatment|All eyes to be treated with riboflavin and UV light
11382278|NCT01398839|BG000|Baseline|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
11382279|NCT01398839|BG001|Baseline|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
11382280|NCT01398839|BG002|Baseline|Total|Total of all reporting groups
11382281|NCT01398839|FG000|Participant Flow|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
11382282|NCT01398839|FG001|Participant Flow|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
11382283|NCT01398839|OG000|Outcome|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
11382284|NCT01398839|OG001|Outcome|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
11382285|NCT01398839|EG000|Reported Event|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
11382286|NCT01398839|EG001|Reported Event|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
11382287|NCT01349959|BG000|Baseline|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11382288|NCT01349959|FG000|Participant Flow|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10786657|NCT01585103|EG000|Reported Event|Cytosponge/ Brushing|"Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.~Cytosponge: An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected."
10786658|NCT01427725|BG000|Baseline|LipaCreon|those with an exposure
10786659|NCT01427725|FG000|Participant Flow|LipaCreon|those with an exposure
10786660|NCT01427725|OG000|Outcome|LipaCreon|those with an exposure
10786661|NCT01427725|OG000|Outcome|Lipacreon|"In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.~Also, the dose was adjusted appropriately according to the patient's condition.~Lipacreon: This study was an observational study and no intervention was specified"
10786662|NCT01427725|EG000|Reported Event|LipaCreon|those with an exposure
10786663|NCT00921115|BG000|Baseline|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
11194681|NCT02153528|OG000|Outcome|Standard TB Treatment|"Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease~Standard TB treatment: Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease"
11194682|NCT02153528|OG001|Outcome|Double Rimfampicin|"2HREZ/4HR Cat. 1, modified by using double dose rifampicin throughout~double rimfampicin: Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained"
10786664|NCT00921115|FG000|Participant Flow|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
10786665|NCT00921115|OG000|Outcome|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
10786666|NCT00921115|EG000|Reported Event|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
10802145|NCT02643420|EG001|Reported Event|Arm 2: Pegfilgrastim and TC -Treatment Period|Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m^2 IV infusion and Cyclophosphamide 600 mg/m^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
10802146|NCT02643420|EG002|Reported Event|Arm 1: SPI-2012 and TC - Follow up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
10802147|NCT02643420|EG003|Reported Event|Arm 2: Pegfilgrastim and TC - Follow up Period|In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
10802148|NCT02639559|BG000|Baseline|Arm 1: Donors|-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10^6 CD34+ cells/kg and at least ≥ 2 x 10^6 CD34+ cells/kg from the combined collections.
11194683|NCT02153528|OG000|Outcome|Double Rifampicin Arm Negative on Auramine Smear|This outcome is only calculated for the intervention arm.
10786667|NCT04608344|BG000|Baseline|Sequence AB|Participants received a single oral dose of ATV 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days.
10786668|NCT04608344|BG001|Baseline|Sequence BA|Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days.
10786669|NCT04608344|BG002|Baseline|Total|Total of all reporting groups
10786670|NCT04608344|FG000|Participant Flow|Sequence AB|Participants received a single oral dose of atorvastatin (ATV) 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of pravastatin (PRA) 40 mg + rosuvastatin (ROS) 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days.
10786671|NCT04608344|FG001|Participant Flow|Sequence BA|Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days.
10786672|NCT04608344|OG000|Outcome|Atorvastatin|Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
10786673|NCT04608344|OG001|Outcome|Pravastatin + Rosuvastatin|Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
10786674|NCT04608344|OG002|Outcome|Filgotinib + Atorvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
10786675|NCT04608344|OG003|Outcome|Filgotinib + Pravastatin + Rosuvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
10786676|NCT04608344|OG002|Outcome|Filgotinib|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1.
10786677|NCT04608344|OG003|Outcome|Filgotinib + Atorvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
10786678|NCT04608344|OG004|Outcome|Filgotinib + Pravastatin + Rosuvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
10786679|NCT04608344|EG000|Reported Event|Atorvastatin|Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2.
10786680|NCT04608344|EG001|Reported Event|Pravastatin + Rosuvastatin|Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2.
10786681|NCT04608344|EG002|Reported Event|Filgotinib|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1.
10786682|NCT04608344|EG003|Reported Event|Filgotinib + Atorvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
10786683|NCT04608344|EG004|Reported Event|Filgotinib + Pravastatin + Rosuvastatin|Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1.
10786684|NCT04569253|BG000|Baseline|RF Device Arm|"Single arm, self controlled.~TempSure: Non-invasive radiofrequency treatments"
10786685|NCT04569253|FG000|Participant Flow|All Study Participants|Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.
10786686|NCT04569253|OG000|Outcome|All Subject Participants|Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.
10786687|NCT04569253|EG000|Reported Event|RF Device|Subjects received treatment on this flank with the RF device.
10786688|NCT04569253|EG001|Reported Event|Control|Subjects received treatments on one flank, and their other flank (which was untreated) was used as the control. No intervention or treatment occurred on this flank.
10786689|NCT04350372|BG000|Baseline|MitraClip|"Subject will receive MitraClip procedure with MitraClip NT System~MitraClip Procedure: MitraClip procedure with MitraClip NT System"
10786690|NCT04350372|FG000|Participant Flow|MitraClip|"Subject will receive MitraClip procedure with MitraClip NT System~MitraClip Procedure: MitraClip procedure with MitraClip NT System"
10786691|NCT04350372|OG000|Outcome|MitraClip|"Subject will receive MitraClip procedure with MitraClip NT System~MitraClip Procedure: MitraClip procedure with MitraClip NT System"
10786692|NCT04350372|EG000|Reported Event|MitraClip|"Subject will receive MitraClip procedure with MitraClip NT System~MitraClip Procedure: MitraClip procedure with MitraClip NT System"
10786693|NCT04343989|BG000|Baseline|Clazakizumab 25 mg|Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
10786694|NCT04343989|BG001|Baseline|Clazakizumab 12.5 mg|Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
10786695|NCT04343989|BG002|Baseline|Placebo|Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
10786696|NCT04343989|BG003|Baseline|Total|Total of all reporting groups
10786697|NCT04343989|FG000|Participant Flow|Clazakizumab 25 mg|Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
10786698|NCT04343989|FG001|Participant Flow|Clazakizumab 12.5 mg|Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
10786699|NCT04343989|FG002|Participant Flow|Placebo|Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
10786700|NCT04343989|OG000|Outcome|Clazakizumab 25 mg|Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
10786701|NCT04343989|OG001|Outcome|Clazakizumab 12.5 mg|Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
10786702|NCT04343989|OG002|Outcome|Placebo|Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
10786703|NCT04343989|EG000|Reported Event|Clazakizumab 25 mg|Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
10786704|NCT04343989|EG001|Reported Event|Clazakizumab 12.5 mg|Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
10786705|NCT04343989|EG002|Reported Event|Placebo|Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
10786706|NCT04328077|BG000|Baseline|Placebo|Placebo Comparator: Placebo: Orally administered
10786707|NCT04328077|BG001|Baseline|TERN-101 5mg|Experimental: TERN-101 dose level 1: Orally administered
10786708|NCT04328077|BG002|Baseline|TERN-101 10mg|Experimental: TERN-101 dose level 2: Orally administered
10786709|NCT04328077|BG003|Baseline|TERN-101 15mg|Experimental: TERN-101 dose level 3: Orally administered
10786710|NCT04328077|BG004|Baseline|Total|Total of all reporting groups
10786711|NCT04328077|FG000|Participant Flow|Placebo|Placebo Comparator: Placebo: Orally administered
10786712|NCT04328077|FG001|Participant Flow|TERN-101 5mg|Experimental: TERN-101 dose level 1: Orally administered
10786713|NCT04328077|FG002|Participant Flow|TERN-101 10mg|Experimental: TERN-101 dose level 2: Orally administered
10786714|NCT04328077|FG003|Participant Flow|TERN-101 15mg|Experimental: TERN-101 dose level 3: Orally administered
10786715|NCT04328077|OG000|Outcome|Placebo|Placebo Comparator: Placebo: Orally administered
10786716|NCT04328077|OG001|Outcome|TERN-101 5 mg|Experimental: TERN-101 dose level 1: Orally administered
10786717|NCT04328077|OG002|Outcome|TERN-101 10 mg|Experimental: TERN-101 dose level 2: Orally administered
10786718|NCT04328077|OG003|Outcome|TERN-101 15 mg|Experimental: TERN-101 dose level 3: Orally administered
11194684|NCT02153528|OG001|Outcome|Double Rifampicin Group Negative on FDA Smear|This outcome is only analysed for the intervention arm.
10786719|NCT04328077|OG000|Outcome|TERN-101 5mg|Experimental: TERN-101 dose level 1: Orally administered
10786720|NCT04328077|OG001|Outcome|TERN-101 10mg|Experimental: TERN-101 dose level 2: Orally administered
10786721|NCT04328077|OG002|Outcome|TERN-101 15mg|Experimental: TERN-101 dose level 3: Orally administered
10786722|NCT04328077|OG000|Outcome|TERN-101 5 mg|Experimental: TERN-101 dose level 1: Orally administered
10786723|NCT04328077|OG001|Outcome|TERN-101 10 mg|Experimental: TERN-101 dose level 2: Orally administered
10786724|NCT04328077|OG002|Outcome|TERN-101 15 mg|Experimental: TERN-101 dose level 3: Orally administered
10786725|NCT04328077|EG000|Reported Event|Placebo|Placebo Comparator: Placebo: Orally administered
10786726|NCT04328077|EG001|Reported Event|TERN-101 5mg|Experimental: TERN-101 dose level 1: Orally administered
10786727|NCT04328077|EG002|Reported Event|TERN-101 10mg|Experimental: TERN-101 dose level 2: Orally administered
10786728|NCT04328077|EG003|Reported Event|TERN-101 15mg|Experimental: TERN-101 dose level 3: Orally administered
10786729|NCT04249310|BG000|Baseline|Tiotropium/Olodaterol (Spiolto®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium/Olodaterol (Tio/Olo) during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
11194685|NCT02153528|EG000|Reported Event|Standard TB Treatment|"Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease~Standard TB treatment: Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease"
10786730|NCT04249310|BG001|Baseline|Tiotropium (Spiriva®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786731|NCT04249310|BG002|Baseline|Total|Total of all reporting groups
10786732|NCT04249310|FG000|Participant Flow|Tiotropium/Olodaterol (Spiolto®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium/Olodaterol (Tio/Olo) during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786733|NCT04249310|FG001|Participant Flow|Tiotropium (Spiriva®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786734|NCT04249310|OG000|Outcome|Tiotropium/Olodaterol (Spiolto®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium/Olodaterol (Tio/Olo) during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786735|NCT04249310|OG001|Outcome|Tiotropium (Spiriva®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786736|NCT04249310|EG000|Reported Event|Tiotropium/Olodaterol (Spiolto®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium/Olodaterol (Tio/Olo) during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10802149|NCT02639559|BG001|Baseline|Arm 2: Recipients|-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
11194686|NCT02153528|EG001|Reported Event|Double Rimfampicin|"2HREZ/4HR Cat. 1, modified by using double dose rifampicin throughout~double rimfampicin: Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained"
11194687|NCT02153671|BG000|Baseline|Control|"Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart."
11194688|NCT02153671|BG001|Baseline|H5N2 Primed|"Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.~A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV"
11194689|NCT02153671|BG002|Baseline|Total|Total of all reporting groups
11194690|NCT02153671|FG000|Participant Flow|H5N2 Primed|"Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.~A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV"
11382289|NCT01349959|OG000|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11382290|NCT01349959|EG000|Reported Event|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11382291|NCT01275677|BG000|Baseline|Arm I (Chemotherapy)|Arm I (chemotherapy)
11382292|NCT01275677|BG001|Baseline|Arm II (Chemotherapy, Trastuzumab)|Arm II (chemotherapy, trastuzumab)
11382293|NCT01275677|BG002|Baseline|Total|Total of all reporting groups
10802150|NCT02639559|BG002|Baseline|Total|Total of all reporting groups
11194691|NCT02153671|FG001|Participant Flow|Control|"Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart."
11194692|NCT02153671|OG000|Outcome|H5N2 Primed|"Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.~A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV"
11382294|NCT01275677|FG000|Participant Flow|Arm I (Chemotherapy)|"GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.~GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Docetaxel: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11382295|NCT01275677|FG001|Participant Flow|Arm II (Chemotherapy, Trastuzumab)|"GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.~GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Docetaxel: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11382296|NCT01275677|OG000|Outcome|Arm I (Chemotherapy)|"GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.~GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Docetaxel: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10786737|NCT04249310|EG001|Reported Event|Tiotropium (Spiriva®)|All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data).
10786738|NCT04234984|BG000|Baseline|Degenerative Knee Pain|All patients with chronic knee pain who suffer from osteoarthritis (OA), soft tissue (e.g., ligament) disease and posttraumatic pain.
10786739|NCT04234984|BG001|Baseline|Persistent Post-surgical Pain (PPSP)|All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee.
10786740|NCT04234984|BG002|Baseline|Total|Total of all reporting groups
10786741|NCT04234984|FG000|Participant Flow|Conventional Radiofrequency (RF) Treatment|All patients with chronic knee pain who qualify for a conventional radiofrequency (RF) treatment of the genicular nerves
10786742|NCT04234984|OG000|Outcome|Degenerative Knee Pain|All patients with chronic knee pain who suffer from OA, soft tissue (e.g., ligament) disease and posttraumatic pain.
10786743|NCT04234984|OG001|Outcome|PPSP|All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee.
10786744|NCT04234984|EG000|Reported Event|Degenerative Knee Pain|All patients with chronic knee pain who suffer from OA, soft tissue (e.g., ligament) disease and posttraumatic pain.
10786745|NCT04234984|EG001|Reported Event|PPSP|All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee.
10786746|NCT04227197|BG000|Baseline|Intervention Group|"The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.~Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome."
10786747|NCT04227197|BG001|Baseline|Control Group|The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured.
10786748|NCT04227197|BG002|Baseline|Total|Total of all reporting groups
10786749|NCT04227197|FG000|Participant Flow|Intervention Group|"The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.~Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome."
10786750|NCT04227197|FG001|Participant Flow|Control Group|The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured.
10786751|NCT04227197|OG000|Outcome|Intervention Group|"The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.~Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome."
11194693|NCT02153671|OG001|Outcome|Control|"Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart."
10786752|NCT04227197|OG001|Outcome|Control Group|The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured.
10786753|NCT04227197|OG000|Outcome|2-week Follow-up Survey for Caregivers in Intervention Arm|"The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.~Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome."
10964745|NCT00878878|OG001|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
11241054|NCT02484651|OG001|Outcome|Deep NMB Group|"Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).~Sugammadex: Reversal of deep neuromuscular block~Rocuronium: Maintenance of deep neuromuscular block"
10786754|NCT04227197|OG001|Outcome|7-month Follow-up Survey for Caregivers in Intervention Arm|The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. 7- months after caregivers shared and discussed the PCP plan at their wellness visit with the PCPs, they received a follow-up survey.
10786755|NCT04227197|OG000|Outcome|Intervention Group|PCPs who had participants randomized to the intervention group (and received DSC2U)
10964746|NCT00878878|OG000|Outcome|Normal Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with normal pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
10786756|NCT04227197|EG000|Reported Event|Intervention Group|"The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.~Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome."
10786757|NCT04227197|EG001|Reported Event|Control Group|The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured.
10786758|NCT04105725|BG000|Baseline|BMI+Substance-Free Activity Session|"Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.~Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests."
10786759|NCT04105725|BG001|Baseline|Alcohol + Nutrition Education Session|"Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.~Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet."
10786760|NCT04105725|BG002|Baseline|Total|Total of all reporting groups
10786761|NCT04105725|FG000|Participant Flow|BMI+Substance-Free Activity Session|"Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.~Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests."
10786762|NCT04105725|FG001|Participant Flow|Alcohol + Nutrition Education Session|"Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.~Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet."
10786763|NCT04105725|OG000|Outcome|BMI+Substance-Free Activity Session|"Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.~Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests."
10786764|NCT04105725|OG001|Outcome|Alcohol + Nutrition Education Session|"Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.~Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet."
10786765|NCT04105725|EG000|Reported Event|BMI+Substance-Free Activity Session|"Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.~Brief Motivational Intervention+Substance-Free Activity Session: A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests."
10786766|NCT04105725|EG001|Reported Event|Alcohol + Nutrition Education Session|"Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.~Alcohol + Nutrition Education Session: Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet."
10786767|NCT04066023|BG000|Baseline|Placebo|"Placebo microneedle system administered as two placebo patches~Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients."
10786768|NCT04066023|BG001|Baseline|C213 1.9 mg|"C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786769|NCT04066023|BG002|Baseline|C213 3.8mg|"C213 3.8 mg administered as two 1.9 mg patches~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786770|NCT04066023|BG003|Baseline|Total|Total of all reporting groups
10786771|NCT04066023|FG000|Participant Flow|Placebo|"Placebo microneedle system administered as two placebo patches~Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients."
10786772|NCT04066023|FG001|Participant Flow|C213 1.9 mg|"C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786773|NCT04066023|FG002|Participant Flow|C213 3.8mg|"C213 3.8 mg administered as two 1.9 mg patches~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786774|NCT04066023|OG000|Outcome|Placebo|"Placebo microneedle system administered as two placebo patches~Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients."
10786775|NCT04066023|OG001|Outcome|C213 1.9 mg|"C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786776|NCT04066023|OG002|Outcome|C213 3.8mg|"C213 3.8 mg administered as two 1.9 mg patches~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786777|NCT04066023|EG000|Reported Event|Placebo|"Placebo microneedle system administered as two placebo patches~Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients."
10786778|NCT04066023|EG001|Reported Event|C213 1.9 mg|"C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786779|NCT04066023|EG002|Reported Event|C213 3.8mg|"C213 3.8 mg administered as two 1.9 mg patches~C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch."
10786780|NCT04011475|BG000|Baseline|Tiotropium+Olodaterol (Group A)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group.
10786781|NCT04011475|BG001|Baseline|Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group.
10786782|NCT04011475|BG002|Baseline|Long-Acting Muscarinic Antagonist (LAMA) (Group C)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Muscarinic Antagonist (LAMA) for 3 months at least prior to 30 June 2018 were included in this group.
10786783|NCT04011475|BG003|Baseline|Total|Total of all reporting groups
10786784|NCT04011475|FG000|Participant Flow|Tiotropium+Olodaterol (Group A)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group.
10786785|NCT04011475|FG001|Participant Flow|Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group.
10786786|NCT04011475|FG002|Participant Flow|Long-Acting Muscarinic Antagonist (LAMA) (Group C)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Muscarinic Antagonist (LAMA) for 3 months at least prior to 30 June 2018 were included in this group.
10786787|NCT04011475|OG000|Outcome|Tiotropium+Olodaterol (Group A)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group.
10786788|NCT04011475|OG001|Outcome|Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group.
10786789|NCT04011475|OG002|Outcome|Long-Acting Muscarinic Antagonist (LAMA) (Group C)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Muscarinic Antagonist (LAMA) for 3 months at least prior to 30 June 2018 were included in this group.
10786790|NCT04011475|EG000|Reported Event|Tiotropium+Olodaterol (Group A)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group.
10786791|NCT04011475|EG001|Reported Event|Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group.
10786792|NCT04011475|EG002|Reported Event|Long-Acting Muscarinic Antagonist (LAMA) (Group C)|Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Muscarinic Antagonist (LAMA) for 3 months at least prior to 30 June 2018 were included in this group.
10786793|NCT03994120|BG000|Baseline|Motor Cortex Stimulation|Healthy participants undergoing stimulation of the motor cortex with rTMS
10786794|NCT03994120|BG001|Baseline|Vertex Stimulation|Healthy participants undergoing stimulation of the vertex with rTMS
10786795|NCT03994120|BG002|Baseline|Total|Total of all reporting groups
10786796|NCT03994120|FG000|Participant Flow|Motor Cortex Stimulation|Healthy participants undergoing stimulation of the motor cortex with rTMS
10786797|NCT03994120|FG001|Participant Flow|Vertex Stimulation|Healthy participants undergoing stimulation of the vertex with rTMS
10786798|NCT03994120|OG000|Outcome|Motor Cortex Stimulation|Healthy participants undergoing stimulation of the motor cortex with rTMS
10786799|NCT03994120|OG001|Outcome|Vertex Stimulation|Healthy participants undergoing stimulation of the vertex with rTMS
10786800|NCT03994120|EG000|Reported Event|Motor Cortex Stimulation|Healthy participants undergoing stimulation of the motor cortex with rTMS
10786801|NCT03994120|EG001|Reported Event|Vertex Stimulation|Healthy participants undergoing stimulation of the vertex with rTMS
10786802|NCT03882957|BG000|Baseline|Individual Participant Data.|This study has a within-subject design where each participant is assigned to all three arms in a randomized fashion. Baseline population data was only collected for adolescents.
10786803|NCT03882957|FG000|Participant Flow|All Study Participants|"This study has a within-subject design where each participant is assigned to all three arms in a randomized manner. The various sequences were:~video --> media multitask --> sustained attention video --> sustained attention --> media multitask media multitask --> video --> sustained attention sustained attention --> video --> media multitask sustained attention --> media multitask --> video media multitask --> sustained attention --> video"
10786804|NCT03882957|OG000|Outcome|Video (Control)|"videos of media tasks being completed~Video: participants will watch a video of media tasks being completed"
10786805|NCT03882957|OG001|Outcome|Media Multi-task|"media tasks~media multi-task: participants will complete multiple media tasks at the same time"
10786806|NCT03882957|OG002|Outcome|Sustained Attention Task|"a cognitive task that trains sustained attention~Sustained attention: participants will complete a sustained attention task"
11194694|NCT02153671|EG000|Reported Event|H5N2 Primed|"Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.~A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV"
11194695|NCT02153671|EG001|Reported Event|Control|"Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.~A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart."
11194696|NCT02153710|BG000|Baseline|Phonomotor Therapy|"Experimental group~Phonomotor Therapy: Experimental therapy."
11194697|NCT02153710|BG001|Baseline|Semantic Feature Analysis Therapy|"Current standard of care therapy~Semantic Feature Analysis therapy: Control therapy; current standard of care therapy"
10786807|NCT03882957|OG000|Outcome|Media Multitasking Scores|
10964747|NCT00878878|OG001|Outcome|Elevated Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with elevated pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
11194698|NCT02153710|BG002|Baseline|Total|Total of all reporting groups
11194699|NCT02153710|FG000|Participant Flow|Phonomotor Therapy|"Experimental group~Phonomotor Therapy: Experimental therapy."
11194700|NCT02153710|FG001|Participant Flow|Semantic Feature Analysis Therapy|"Current standard of care therapy~Semantic Feature Analysis therapy: Control therapy; current standard of care therapy"
10786808|NCT03882957|EG000|Reported Event|Video|"videos of media tasks being completed~Video: participants will watch a video of media tasks being completed"
10786809|NCT03882957|EG001|Reported Event|Media Multi-task|"media tasks~media multi-task: participants will complete multiple media tasks at the same time"
10786810|NCT03882957|EG002|Reported Event|Sustained Attention Task|"a cognitive task that trains sustained attention~Sustained attention: participants will complete a sustained attention task"
10786811|NCT03711500|BG000|Baseline|D-serine 80 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786812|NCT03711500|BG001|Baseline|Placebo|Placebo: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786813|NCT03711500|BG002|Baseline|D-serine 100 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786814|NCT03711500|BG003|Baseline|D-serine 120 mg/g|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786815|NCT03711500|BG004|Baseline|Total|Total of all reporting groups
10786816|NCT03711500|FG000|Participant Flow|D-serine 80 mg/kg|D-serine 80 m/kg
10786817|NCT03711500|FG001|Participant Flow|D-serine 100 mg/kg|D-serine 100 mg/kg
10786818|NCT03711500|FG002|Participant Flow|D-serine 120 mg/kg|D-serine 120 mg/kg
10786819|NCT03711500|FG003|Participant Flow|Placebo|Placebo
10786820|NCT03711500|OG000|Outcome|D-serine 80 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786821|NCT03711500|OG001|Outcome|Placebo|Placebo: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10964748|NCT00878878|EG000|Reported Event|Optison Product First Followed by Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
11194701|NCT02153710|OG000|Outcome|Phonomotor Therapy|"Experimental group~Phonomotor Therapy: Experimental therapy."
11194702|NCT02153710|OG001|Outcome|Semantic Feature Analysis Therapy|"Current standard of care therapy~Semantic Feature Analysis therapy: Control therapy; current standard of care therapy"
10786822|NCT03711500|OG002|Outcome|D-serine 100 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786823|NCT03711500|OG003|Outcome|D-serine 120 mg/g|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786824|NCT03711500|EG000|Reported Event|D-serine 80 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786825|NCT03711500|EG001|Reported Event|Placebo|Placebo: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786826|NCT03711500|EG002|Reported Event|D-serine 100 mg/kg|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786827|NCT03711500|EG003|Reported Event|D-serine 120 mg/g|D-serine: Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
10786828|NCT03639558|BG000|Baseline|Haloperidol + Promethazine + Chlorpromazine|Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.
10786829|NCT03639558|BG001|Baseline|Haloperidol + Promethazine|Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
10786830|NCT03639558|BG002|Baseline|Total|Total of all reporting groups
10786831|NCT03639558|FG000|Participant Flow|Haloperidol + Promethazine + Chlorpromazine|Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.
10786832|NCT03639558|FG001|Participant Flow|Haloperidol + Promethazine|Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
10786833|NCT03639558|OG000|Outcome|Haloperidol + Promethazine + Chlorpromazine|Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.
10786834|NCT03639558|OG001|Outcome|Haloperidol + Promethazine|Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
10786835|NCT03639558|EG000|Reported Event|Haloperidol + Promethazine + Chlorpromazine|Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.
10786836|NCT03639558|EG001|Reported Event|Haloperidol + Promethazine|Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
10786837|NCT03630770|BG000|Baseline|Control|This group receives no feeding supplement.
10786838|NCT03630770|BG001|Baseline|MCT Oil|"This group is supplemented with MCT oil~Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge."
10786839|NCT03630770|BG002|Baseline|Total|Total of all reporting groups
10786840|NCT03630770|FG000|Participant Flow|Control|This group receives no feeding supplement.
10786841|NCT03630770|FG001|Participant Flow|MCT Oil|"This group is supplemented with MCT oil~Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge."
10786842|NCT03630770|OG000|Outcome|Control|This group receives no feeding supplement.
10786843|NCT03630770|OG001|Outcome|MCT Oil|"This group is supplemented with MCT oil~Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge."
10786844|NCT03630770|EG000|Reported Event|Control|This group receives no feeding supplement.
10786845|NCT03630770|EG001|Reported Event|MCT Oil|"This group is supplemented with MCT oil~Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge."
10964749|NCT00878878|EG001|Reported Event|Placebo Control (5% Dextrose) First Followed by the Optison|Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
10964750|NCT00878995|BG000|Baseline|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
10964751|NCT00878995|BG001|Baseline|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
10964752|NCT00878995|BG002|Baseline|Total|Total of all reporting groups
10964753|NCT00878995|FG000|Participant Flow|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
11194703|NCT02153710|EG000|Reported Event|Phonomotor Therapy|"Experimental group~Phonomotor Therapy: Experimental therapy."
11194704|NCT02153710|EG001|Reported Event|Semantic Feature Analysis Therapy|"Current standard of care therapy~Semantic Feature Analysis therapy: Control therapy; current standard of care therapy"
10964754|NCT00878995|FG001|Participant Flow|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
10964755|NCT00878995|OG000|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
10964756|NCT00878995|OG001|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
10964757|NCT00878995|EG000|Reported Event|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
10964758|NCT00878995|EG001|Reported Event|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
10786855|NCT03387852|BG000|Baseline|Placebo|Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.
10786856|NCT03387852|BG001|Baseline|SAR440340 300 mg|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.
10786857|NCT03387852|BG002|Baseline|SAR440340 + Dupilumab|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
10786858|NCT03387852|BG003|Baseline|Dupilumab 300 mg|Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
10786859|NCT03387852|BG004|Baseline|Total|Total of all reporting groups
10786860|NCT03387852|FG000|Participant Flow|Placebo|Participants received 2 subcutaneous (SC) injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo once every 2 weeks (Q2W) for 12 weeks.
10786861|NCT03387852|FG001|Participant Flow|SAR440340 300 mg|Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.
10786862|NCT03387852|FG002|Participant Flow|SAR440340 + Dupilumab|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
10786863|NCT03387852|FG003|Participant Flow|Dupilumab 300 mg|Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
10786864|NCT03387852|OG000|Outcome|Placebo|Participants received 2 SC injections of placebo matching to SAR440340 along with 1 SC injection of placebo matching to dupilumab once Q2W for 12 weeks.
10786865|NCT03387852|OG001|Outcome|SAR440340 300 mg|Participants received 2 injections of SAR440340 300 mg along with 1 injection of placebo matching to dupilumab, SC Q2W for 12 weeks.
10786866|NCT03387852|OG002|Outcome|SAR440340 + Dupilumab|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
10786867|NCT03387852|OG003|Outcome|Dupilumab 300 mg|Participants received 1 injection of dupilumab 300 mg along with 2 injections of placebo matched to SAR440340, SC Q2W for 12 weeks.
10786868|NCT03387852|OG000|Outcome|Placebo|Participants received 2 SC injections of placebo matching to SAR440340 along with 1 SC injection of placebo matching to dupilumab Q2W for 12 weeks.
10786869|NCT03387852|EG000|Reported Event|Placebo|Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.
10786870|NCT03387852|EG001|Reported Event|SAR440340 300mg|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.
10786871|NCT03387852|EG002|Reported Event|SAR440340 + Dupilumab|Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
10786872|NCT03387852|EG003|Reported Event|Dupilumab 300mg|Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
11194705|NCT02153723|BG000|Baseline|Copaxone|"Dose escalation:~Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.~Glatiramer Acetate"
10786873|NCT03382574|BG000|Baseline|Arm I (Denosumab, Risk-reducing Salpingo-oophorectomy)/ Arm II (Risk-reducing Salpingo-oophorectomy)|"Beginning within 3 days of menstrual cycle, patients receive denosumab SC every 4 weeks for 1-2 doses and undergo risk-reducing salpingo-oophorectomy 14-28 days after last dose.~Denosumab: Given SC~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy~Arm II Patients receive no treatment for 2-8 weeks and then undergo risk-reducing salpingo-oophorectomy.~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10786874|NCT03382574|FG000|Participant Flow|Arm I (Denosumab, Risk-reducing Salpingo-oophorectomy)/Arm II (Risk-reducing Salpingo-oophorectomy)|"Beginning within 3 days of menstrual cycle, patients receive denosumab SC every 4 weeks for 1-2 doses and undergo risk-reducing salpingo-oophorectomy 14-28 days after last dose.~Denosumab: Given SC~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy~Arm II Patients receive no treatment for 2-8 weeks and then undergo risk-reducing salpingo-oophorectomy.~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10966621|NCT00887822|OG000|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
11194706|NCT02153723|FG000|Participant Flow|Copaxone|"Dose escalation:~Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.~Glatiramer Acetate"
10786875|NCT03382574|OG000|Outcome|Arm I (Denosumab, Risk-reducing Salpingo-oophorectomy)|"Beginning within 3 days of menstrual cycle, patients receive denosumab SC every 4 weeks for 1-2 doses and undergo risk-reducing salpingo-oophorectomy 14-28 days after last dose.~Denosumab: Given SC~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10786876|NCT03382574|OG001|Outcome|Arm II (Risk-reducing Salpingo-oophorectomy)|"Patients receive no treatment for 2-8 weeks and then undergo risk-reducing salpingo-oophorectomy.~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10786877|NCT03382574|EG000|Reported Event|Arm I (Denosumab, Risk-reducing Salpingo-oophorectomy)|"Beginning within 3 days of menstrual cycle, patients receive denosumab SC every 4 weeks for 1-2 doses and undergo risk-reducing salpingo-oophorectomy 14-28 days after last dose.~Denosumab: Given SC~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10786878|NCT03382574|EG001|Reported Event|Arm II (Risk-reducing Salpingo-oophorectomy)|"Patients receive no treatment for 2-8 weeks and then undergo risk-reducing salpingo-oophorectomy.~Salpingo-Oophorectomy: Undergo risk-reducing salpingo-oophorectomy"
10786879|NCT03364673|BG000|Baseline|Fitness Tracker + Social Incentive Intervention|"Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.~Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes~Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes."
10786880|NCT03364673|FG000|Participant Flow|Fitness Tracker + Social Incentive Intervention|"Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.~Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes~Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes."
10786881|NCT03364673|OG000|Outcome|Fitness Tracker + Social Incentive Intervention|"Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.~Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes~Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes."
10786882|NCT03364673|EG000|Reported Event|Fitness Tracker + Social Incentive Intervention|"Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.~Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes~Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes."
11194707|NCT02153723|OG000|Outcome|Copaxone|"Dose escalation:~Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.~Glatiramer Acetate"
11194708|NCT02153723|EG000|Reported Event|Copaxone|"Dose escalation:~Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.~Glatiramer Acetate"
10786883|NCT03343704|BG000|Baseline|Group A - Patients With Uncontrolled or Life-threatening Bleeding|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group."
10786884|NCT03343704|BG001|Baseline|Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable."
10786885|NCT03343704|BG002|Baseline|Total|Total of all reporting groups
10786886|NCT03343704|FG000|Participant Flow|Group A - Patients With Uncontrolled or Life-threatening Bleeding|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group."
10803767|NCT02134028|OG000|Outcome|Participants From EFC13691: Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11194709|NCT02153736|BG000|Baseline|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
10786887|NCT03343704|FG001|Participant Flow|Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable."
10786888|NCT03343704|OG000|Outcome|Group A - Patients With Uncontrolled or Life-threatening Bleeding|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group."
10786889|NCT03343704|OG001|Outcome|Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable."
10786890|NCT03343704|OG002|Outcome|Total|All participants in Group A or B were included in this group.
10786891|NCT03343704|OG000|Outcome|Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable."
10786892|NCT03343704|EG000|Reported Event|Group A - Patients With Uncontrolled or Life-threatening Bleeding|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group."
10786893|NCT03343704|EG001|Reported Event|Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure|"Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart.~Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable."
10786894|NCT03265145|BG000|Baseline|Stiolto® Respimat®|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786895|NCT03265145|BG001|Baseline|ICS Plus LABA Plus LAMA (Triple Therapy)|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786896|NCT03265145|BG002|Baseline|Total|Total of all reporting groups
10786897|NCT03265145|FG000|Participant Flow|Stiolto® Respimat®|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786898|NCT03265145|FG001|Participant Flow|ICS Plus LABA Plus LAMA (Triple Therapy)|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10802151|NCT02639559|FG000|Participant Flow|Arm 1: Donors|-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10^6 CD34+ cells/kg and at least ≥ 2 x 10^6 CD34+ cells/kg from the combined collections.
10786899|NCT03265145|OG000|Outcome|Stiolto® Respimat®|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786900|NCT03265145|OG001|Outcome|ICS Plus LABA Plus LAMA (Triple Therapy)|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786901|NCT03265145|OG001|Outcome|Triple Therapy|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients were switched to a treatment of ICS plus LABA plus LAMA (triple therapy), made up of the combination of any approved drugs that their physician chooses, for 12 months of treatment."
10786902|NCT03265145|EG000|Reported Event|Stiolto® Respimat®|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786903|NCT03265145|EG001|Reported Event|ICS Plus LABA Plus LAMA (Triple Therapy)|"Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.~Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment."
10786904|NCT03219164|BG000|Baseline|AZLI 14 Days + Placebo 14 Days|75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786905|NCT03219164|BG001|Baseline|AZLI 28 Days|75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786906|NCT03219164|BG002|Baseline|Total|Total of all reporting groups
10786907|NCT03219164|FG000|Participant Flow|AZLI 14 Days + Placebo 14 Days|75 milligrams per milliliter (mg/ml) of aztreonam was administered thrice daily (TID) for 14 days followed by placebo to match (PTM) aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received aztreonam for inhalation solution (AZLI) and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10966622|NCT00887822|OG001|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
11194710|NCT02153736|BG001|Baseline|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
10786908|NCT03219164|FG001|Participant Flow|AZLI 28 Days|75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786909|NCT03219164|OG000|Outcome|AZLI 14 Days + Placebo 14 Days|75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786910|NCT03219164|OG001|Outcome|AZLI 28 Days|75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786911|NCT03219164|EG000|Reported Event|AZLI 14 Days + Placebo 14 Days|75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786912|NCT03219164|EG001|Reported Event|AZLI 28 Days|75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
10786913|NCT03143153|BG000|Baseline|Arm A: Nivolumab + Ipilimumab|Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
10786914|NCT03143153|BG001|Baseline|Arm B: Nivolumab + Chemotherapy|Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786915|NCT03143153|BG002|Baseline|Arm C: Chemotherapy|Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786916|NCT03143153|BG003|Baseline|Total|Total of all reporting groups
10786917|NCT03143153|FG000|Participant Flow|Arm A: Nivolumab + Ipilimumab|Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
10786918|NCT03143153|FG001|Participant Flow|Arm B: Nivolumab + Chemotherapy|Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786919|NCT03143153|FG002|Participant Flow|Arm C: Chemotherapy|Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786920|NCT03143153|OG000|Outcome|Arm A: Nivolumab + Ipilimumab|Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
10786921|NCT03143153|OG001|Outcome|Arm B: Nivolumab + Chemotherapy|Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
11194711|NCT02153736|BG002|Baseline|Total|Total of all reporting groups
11194712|NCT02153736|FG000|Participant Flow|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
11194713|NCT02153736|FG001|Participant Flow|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
11194714|NCT02153736|OG000|Outcome|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
11194715|NCT02153736|OG001|Outcome|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
10786922|NCT03143153|OG002|Outcome|Arm C: Chemotherapy|Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786923|NCT03143153|EG000|Reported Event|Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg|Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
10786924|NCT03143153|EG001|Reported Event|Nivolumab 240 mg + Chemotherapy|Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786925|NCT03143153|EG002|Reported Event|Chemotherapy|Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
10786926|NCT03104413|BG000|Baseline|Placebo (Induction Period 1)|"Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.~placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion."
10786927|NCT03104413|BG001|Baseline|Risankizumab 600mg (Induction Period 1)|"Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786928|NCT03104413|BG002|Baseline|Risankizumab 1200mg (Induction Period 1)|"Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786929|NCT03104413|BG003|Baseline|Total|Total of all reporting groups
10786930|NCT03104413|FG000|Participant Flow|Placebo (Induction Period 1)|"Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.~placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion."
10786931|NCT03104413|FG001|Participant Flow|Risankizumab 600mg (Induction Period 1)|"Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786932|NCT03104413|FG002|Participant Flow|Risankizumab 1200mg (Induction Period 1)|"Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786933|NCT03104413|FG003|Participant Flow|Risankizumab Dose 180mg (Induction Period 2)|"Participants randomized to receive risankizumab 180mg by subcutaneous(SC) injection at Weeks 12 and 20.~risankizumab SC: risankizumab administered by subcutaneous (SC) injection."
11194716|NCT02153736|EG000|Reported Event|Usual Care Group|This group of subjects will receive usual care provided in the medial system and community.
10786934|NCT03104413|FG004|Participant Flow|Risankizumab 360mg (Induction Period 2)|"Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.~risankizumab SC: risankizumab administered by subcutaneous (SC) injection"
10786935|NCT03104413|FG005|Participant Flow|Risankizumab 1200mg (Induction Period 2)|"Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786936|NCT03104413|FG006|Participant Flow|Placebo/Risankizumab 1200mg (Induction Period 2)|"Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786937|NCT03104413|OG000|Outcome|Placebo (Induction Period 1)|"Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.~placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion."
10786938|NCT03104413|OG001|Outcome|Risankizumab 600mg (Induction Period 1)|"Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786939|NCT03104413|OG002|Outcome|Risankizumab 1200mg (Induction Period 1)|"Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.~risankizumab IV: risankizumab administered as intravenous (IV) infusion."
10786940|NCT03104413|EG000|Reported Event|Placebo (Induction Period 1)|Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
10786941|NCT03104413|EG001|Reported Event|Risankizumab 600mg (Induction Period 1)|Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
10786942|NCT03104413|EG002|Reported Event|Risankizumab 1200mg (Induction Period 1)|Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
11194717|NCT02153736|EG001|Reported Event|SPEEDI Intervention|"This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.~SPEEDI Intervention: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities."
11194718|NCT02153788|BG000|Baseline|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
10786943|NCT03104413|EG003|Reported Event|Period 1 Risankizumab Total|Total Period 1 participants randomized into the Risankizumab treatment arm
10786944|NCT03104413|EG004|Reported Event|Risankizumab Dose 180mg (Induction Period 2)|Participants randomized to receive risankizumab 180mg by subcutaneous (SC) injection at Weeks 12 and 20.
10786945|NCT03104413|EG005|Reported Event|Risankizumab 360mg (Induction Period 2)|Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
10786946|NCT03104413|EG006|Reported Event|Risankizumab 1200mg (Induction Period 2)|Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
10786947|NCT03104413|EG007|Reported Event|Placebo/Risankizumab 1200mg (Induction Period 2)|Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
10786948|NCT03104413|EG008|Reported Event|Period 2 Risankizumab Total|Total Period 2 participants randomized into the Risankizumab treatment arm
10786949|NCT02930590|BG000|Baseline|AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam|Cross-over trial. In total 15 participants, each of them lied on every of the three types of mattress.
10786950|NCT02930590|FG000|Participant Flow|Low Pressure, Reactive Support, Than Standard Mattress|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786951|NCT02930590|FG001|Participant Flow|Low Pressure, Standard Mattress, Than Reactive Support|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786952|NCT02930590|FG002|Participant Flow|Reactive Support, Low Pressure, Than Standard Mattress|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786953|NCT02930590|FG003|Participant Flow|Reactive Support, Standard Mattress, Than Low Pressure|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786954|NCT02930590|FG004|Participant Flow|Standard Mattress, Low Pressure, Than Reactive Support|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786955|NCT02930590|FG005|Participant Flow|Standard Mattress, Reactive Support, Than Low Pressure|Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA)
10786956|NCT02930590|OG000|Outcome|Alternating Low Pressure Mattress|"Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)~Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA"
10786957|NCT02930590|OG001|Outcome|Reactive Support Surface|"Gel mattress (IsoGel, Stryker, USA)~Gel mattress: IsoGel, Stryker, USA"
10786958|NCT02930590|OG002|Outcome|Standard Mattress|"Basic foam (Stryker, USA)~Basic foam: Standard mattress, Stryker, USA"
10786959|NCT02930590|OG002|Outcome|Standard Mattress|"Basic foam (IsoGel, Stryker, USA)~Basic foam: Standard mattress, Stryker, USA"
10786960|NCT02930590|OG000|Outcome|Standard Mattress|Basic foam: Standard mattress, Stryker, USA
10786961|NCT02930590|EG000|Reported Event|Alternating Low Pressure Mattress|"Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)~Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA"
10786962|NCT02930590|EG001|Reported Event|Reactive Support Surface|"Gel mattress (IsoGel, Stryker, USA)~Gel mattress: IsoGel, Stryker, USA"
10786963|NCT02930590|EG002|Reported Event|Standard Mattress|"Basic foam (IsoGel, Stryker, USA)~Basic foam: Standard mattress, Stryker, USA"
10786964|NCT02921789|BG000|Baseline|SOC Regimen|Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786965|NCT02921789|BG001|Baseline|Bleselumab Regimen|Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786966|NCT02921789|BG002|Baseline|Total|Total of all reporting groups
10786967|NCT02921789|FG000|Participant Flow|Standard of Care (SOC) Regimen|Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786968|NCT02921789|FG001|Participant Flow|Bleselumab Regimen|Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
11194719|NCT02153788|BG001|Baseline|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
11194720|NCT02153788|BG002|Baseline|Total|Total of all reporting groups
11194721|NCT02153788|FG000|Participant Flow|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
11194722|NCT02153788|FG001|Participant Flow|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
11194723|NCT02153788|OG000|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
11194724|NCT02153788|OG001|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
11194725|NCT02153788|EG000|Reported Event|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
11194726|NCT02153788|EG001|Reported Event|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
11194727|NCT02153827|BG000|Baseline|Eccentric External Rotator Training|"Eccentric Shoulder External Rotator Training~Eccentric Shoulder External Rotator Training"
10802152|NCT02639559|FG001|Participant Flow|Arm 2: Recipients|-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
10786969|NCT02921789|OG000|Outcome|SOC Regimen|Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786970|NCT02921789|OG001|Outcome|Bleselumab Regimen|Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786971|NCT02921789|EG000|Reported Event|SOC Regimen|Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786972|NCT02921789|EG001|Reported Event|Bleselumab Regimen|Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
10786973|NCT02898077|BG000|Baseline|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|"8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786974|NCT02898077|BG001|Baseline|Placebo + 80 mg/m² Paclitaxel|"Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786975|NCT02898077|BG002|Baseline|Total|Total of all reporting groups
10786976|NCT02898077|FG000|Participant Flow|8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel|"8 mg/kg ramucirumab was administered as an intravenous infusion (IV) on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
11194728|NCT02153827|BG001|Baseline|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
10786977|NCT02898077|FG001|Participant Flow|Placebo + 80 mg/m² Paclitaxel|"Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786978|NCT02898077|OG000|Outcome|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|"8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
11194729|NCT02153827|BG002|Baseline|Total|Total of all reporting groups
11194730|NCT02153827|FG000|Participant Flow|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
11194731|NCT02153827|FG001|Participant Flow|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
11194732|NCT02153827|OG000|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
11194733|NCT02153827|OG001|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
11194734|NCT02153827|EG000|Reported Event|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
11194735|NCT02153827|EG001|Reported Event|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
11241055|NCT02484651|OG001|Outcome|Deep NMB Group|"Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC(Post-Tetanic-Count) less or equal to 2 on the TOF(Train of Four) monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).~Sugammadex: Reversal of deep neuromuscular block~Rocuronium: Maintenance of deep neuromuscular block"
10786979|NCT02898077|OG001|Outcome|Placebo + 80 mg/m² Paclitaxel|"Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786980|NCT02898077|EG000|Reported Event|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|"8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786981|NCT02898077|EG001|Reported Event|Placebo + 80 mg/m² Paclitaxel|"Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle.~Participants may continue on treatment until discontinuation criteria were met."
10786982|NCT02702271|BG000|Baseline|WATCHMAN FLX - M|"Main Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786983|NCT02702271|BG001|Baseline|WATCHMAN FLX - R|"Roll-In Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786984|NCT02702271|BG002|Baseline|Total|Total of all reporting groups
10786985|NCT02702271|FG000|Participant Flow|WATCHMAN FLX - M|"Main Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786986|NCT02702271|FG001|Participant Flow|WATCHMAN FLX - R|"Roll-In Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786987|NCT02702271|OG000|Outcome|WATCHMAN FLX - M|"Main Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786988|NCT02702271|OG001|Outcome|WATCHMAN FLX - R|"Roll-In Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786989|NCT02702271|EG000|Reported Event|WATCHMAN FLX - M|"Main Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786990|NCT02702271|EG001|Reported Event|WATCHMAN FLX - R|"Roll-In Cohort~WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX"
10786991|NCT02658136|BG000|Baseline|1 Arm Study: CCT Estimated Right Ventricular Function.|Cardiac Computed tomography
10786992|NCT02658136|FG000|Participant Flow|1 Arm Study: CCT Estimated Right Ventricular Function.|Fifteen patients with HeartMate (HM) II or III underwent echocardiography and maximal cardiopulmonary exercise test. Subsequently, contrast-enhanced 4D Cardiac Computed Tomography(CCT) scans were performed at rest and immediately after two minutes of supine 25 Watt ergometer bike exercise.
10786993|NCT02658136|OG000|Outcome|Single-arm Study: Exercise and Right Ventricular Function in Patients With LVADs|Peak oxygen uptake (ml/kg/min) was measured on upright ergometer bicycle
10786994|NCT02658136|OG000|Outcome|CCT Estimated Right Ventricular Function.|Right ventricular ejection fraction was estimated by use of contrast-enhanced CCT in all study participants.
10786995|NCT02658136|EG000|Reported Event|1 Arm Study: CCT Estimated Right Ventricular Function.|Fifteen patients with HeartMate (HM) II or 3 underwent echocardiography and maximal cardiopulmonary exercise test. Subsequently, contrast-enhanced four-dimensional (4D) cardiac computed tomography (CCT) scans were performed at rest and immediately after two minutes of supine 25 Watt ergometer bike exercise.
10786996|NCT02558634|BG000|Baseline|All Study Participants|"Patients who are currently receiving BTX injections for their voice disorder~Who experience fluctuations in their symptom control as a result of their BTX therapy~Patients who fall into the age range of 18-75 years old"
10786997|NCT02558634|FG000|Participant Flow|DBS-on First, Then DBS-off (Sham-stimulation)|"Ventral intermediate Nucleus (VIM) Thalamic DBS on for the first 3 months, then Thalamic DBS off for the next 3 months~DBS system includes:~Implantable Pulse Generator (IPG)~DBS Lead~DBS Lead Extension Kit~VIM Thalamic DBS ON for first 3 months, then Thalamic DBS OFF for following 3 months"
10786998|NCT02558634|FG001|Participant Flow|DBS-off First (Sham-stimulation), Then DBS-on|"Ventral intermediate Nucleus (VIM) Thalamic DBS off (Sham-stimulation) for the first 3 months, then Thalamic DBS on for the following 3 months~DBS system includes:~Implantable Pulse Generator (IPG)~DBS Lead~DBS Lead Extension Kit~VIM Thalamic Deep Brain Stimulation OFF for first 3 months, followed by VIM Thalamic Deep Brain Stimulation ON for the following 3 months"
10786999|NCT02558634|OG000|Outcome|Blinded-DBS ON|All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
10787000|NCT02558634|OG001|Outcome|Blinded-DBS OFF|All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
10787001|NCT02558634|OG000|Outcome|Open-DBS ON|All participants in the study were assessed using the BDI-II pre-operatively and then again at the end of the 6-month open DBS ON phase (1 year post-op).
10787002|NCT02558634|OG000|Outcome|Open-DBS ON|All participants in the study were assessed using the MoCA pre-operatively and then again at the end of the 6-month open DBS ON phase (1 year post-op).
10787003|NCT02558634|OG000|Outcome|Open-DBS ON|All participants in the study were assessed using the VHI pre-operatively and then again at the end of the 6-month open DBS ON phase (1 year post-op).
10787004|NCT02558634|EG000|Reported Event|Blinded DBS-ON|When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported.
10787005|NCT02558634|EG001|Reported Event|Blinded DBS-OFF|When DBS was turned off, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported.
10787006|NCT02558634|EG002|Reported Event|Open DBS-ON|When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported.
10787007|NCT02471339|BG000|Baseline|1/Acceptance and Commitment Therapy (ACT) Group|"2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787008|NCT02471339|BG001|Baseline|2/Waitlist (WL) Group|"Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787009|NCT02471339|BG002|Baseline|Total|Total of all reporting groups
10787010|NCT02471339|FG000|Participant Flow|1/Acceptance and Commitment Therapy (ACT) Group|"2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787011|NCT02471339|FG001|Participant Flow|2/Waitlist (WL) Group|"Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787012|NCT02471339|OG000|Outcome|1/Acceptance and Commitment Therapy (ACT) Group|"2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787013|NCT02471339|OG001|Outcome|2/Waitlist (WL) Group|"Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787014|NCT02471339|EG000|Reported Event|1/Acceptance and Commitment Therapy (ACT) Group|"2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787015|NCT02471339|EG001|Reported Event|2/Waitlist (WL) Group|"Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)~Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain."
10787016|NCT02470585|BG000|Baseline|Placebo + Carboplatin + Paclitaxel -> Placebo|"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787017|NCT02470585|BG001|Baseline|Veliparib + Carboplatin + Paclitaxel -> Placebo|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787018|NCT02470585|BG002|Baseline|Veliparib + Carboplatin + Paclitaxel -> Veliparib|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy."
10787019|NCT02470585|BG003|Baseline|Total|Total of all reporting groups
10787020|NCT02470585|FG000|Participant Flow|Placebo + Carboplatin + Paclitaxel -> Placebo|"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787021|NCT02470585|FG001|Participant Flow|Veliparib + Carboplatin + Paclitaxel -> Placebo|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787022|NCT02470585|FG002|Participant Flow|Veliparib + Carboplatin + Paclitaxel -> Veliparib|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy."
11241056|NCT02484651|EG000|Reported Event|Standard Group|Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.
11241057|NCT02484651|EG001|Reported Event|Deep NMB Group|"Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).~Sugammadex: Reversal of deep neuromuscular block~Rocuronium: Maintenance of deep neuromuscular block"
10787023|NCT02470585|OG000|Outcome|Placebo + Carboplatin + Paclitaxel -> Placebo|"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787024|NCT02470585|OG001|Outcome|Veliparib + Carboplatin + Paclitaxel -> Placebo|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787025|NCT02470585|OG002|Outcome|Veliparib + Carboplatin + Paclitaxel -> Veliparib|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy."
10787026|NCT02470585|EG000|Reported Event|Placebo + Carboplatin + Paclitaxel -> Placebo|"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787027|NCT02470585|EG001|Reported Event|Veliparib + Carboplatin + Paclitaxel -> Placebo|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy."
10787028|NCT02470585|EG002|Reported Event|Veliparib + Carboplatin + Paclitaxel -> Veliparib|"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.~Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy."
10787029|NCT02426749|BG000|Baseline|Active Coil|Participants of this arm received active rTMS intervention (treatment). Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments were administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups received rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC on the left side at 100% of the resting motor threshold. Thus, there was a total of 750 pulses per day, which was well within the safety limit of the rTMS application.
10787030|NCT02426749|BG001|Baseline|Sham|Participants of this arm received sham rTMS intervention (treatment). Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS was similar to Active rTMS but instead of a real coil, it used a coil that attenuates the pulses such that no current will be induced in the brain.
10787031|NCT02426749|BG002|Baseline|Total|Total of all reporting groups
10787032|NCT02426749|FG000|Participant Flow|Active Coil|"Participants of this arm received active rTMS intervention (treatment).~Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments were administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups received rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC on the left side at 100% of the resting motor threshold. Thus, there was a total of 750 pulses per day, which was well within the safety limit of the rTMS application."
10787033|NCT02426749|FG001|Participant Flow|Sham|"Participants of this arm received sham rTMS intervention (treatment).~Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS was similar to Active rTMS but instead of a real coil, it used a coil that attenuates the pulses such that no current will be induced in the brain."
10787034|NCT02426749|OG000|Outcome|Active Coil|Participants of this arm will receive active rTMS intervention (treatment).
10787035|NCT02426749|OG001|Outcome|Sham|Participants of this arm will receive sham rTMS intervention (treatment).
10787036|NCT02426749|OG000|Outcome|Active Coil|"Participants of this arm received active rTMS intervention (treatment).~Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments were administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups received rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC on the left side at 100% of the resting motor threshold. Thus, there was a total of 750 pulses per day, which was well within the safety limit of the rTMS application."
10787037|NCT02426749|OG001|Outcome|Sham|"Participants of this arm received sham rTMS intervention (treatment).~Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS was similar to Active rTMS but instead of a real coil, it used a coil that attenuates the pulses such that no current will be induced in the brain."
10802153|NCT02639559|OG000|Outcome|Arm 1: Donors|-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10^6 CD34+ cells/kg and at least ≥ 2 x 10^6 CD34+ cells/kg from the combined collections.
11382297|NCT01275677|OG001|Outcome|Arm II (Chemotherapy, Trastuzumab)|"GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.~GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Docetaxel: Given IV~Doxorubicin: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11382298|NCT01275677|EG000|Reported Event|Arm I (Chemotherapy)|Arm I (chemotherapy)
11382299|NCT01275677|EG001|Reported Event|Arm II (Chemotherapy, Trastuzumab)|Arm II (chemotherapy, trastuzumab)
11382300|NCT01251861|BG000|Baseline|Arm A (Observation and Bicalutamide)|Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382301|NCT01251861|BG001|Baseline|Arm B (Akt Inhibitor MK2206 and Bicalutamide)|Patients receive Akt inhibitor MK2206 PO once per week on weeks 1-44 and bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382302|NCT01251861|BG002|Baseline|Total|Total of all reporting groups
11382303|NCT01251861|FG000|Participant Flow|Arm A (Observation and Bicalutamide)|Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382304|NCT01251861|FG001|Participant Flow|Arm B (Akt Inhibitor MK2206 and Bicalutamide)|Patients receive Akt inhibitor MK2206 PO once per week on weeks 1-44 and bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382305|NCT01251861|OG000|Outcome|Arm A (Observation and Bicalutamide)|Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382306|NCT01251861|OG001|Outcome|Arm B (Akt Inhibitor MK2206 and Bicalutamide)|Patients receive Akt inhibitor MK2206 PO once per week on weeks 1-44 and bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382307|NCT01251861|EG000|Reported Event|Arm A (Observation + Bicalutamide)|Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382308|NCT01251861|EG001|Reported Event|Arm B (MK-2206 + Bicalutamide)|Patients receive Akt inhibitor MK2206 PO once per week on weeks 1-44 and bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
11382309|NCT01196390|BG000|Baseline|Chemoradiation and Trastuzumab|Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
11382310|NCT01196390|BG001|Baseline|Chemoradiation|Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
11382311|NCT01196390|BG002|Baseline|Total|Total of all reporting groups
11382312|NCT01196390|FG000|Participant Flow|Chemoradiation and Trastuzumab|Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
11382313|NCT01196390|FG001|Participant Flow|Chemoradiation|Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
11382314|NCT01196390|OG000|Outcome|Chemoradiation and Trastuzumab (Arm 1)|Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
11382315|NCT01196390|OG001|Outcome|Chemoradiation (Arm 2)|Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
11382316|NCT01196390|OG000|Outcome|Chemoradiation and Trastuzumab|Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
11382317|NCT01196390|OG001|Outcome|Chemoradiation|Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
11382318|NCT01196390|EG000|Reported Event|Chemoradiation and Trastuzumab|Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
11382319|NCT01196390|EG001|Reported Event|Chemoradiation|Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
11382320|NCT01168219|BG000|Baseline|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
11382321|NCT01168219|FG000|Participant Flow|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
10787038|NCT02426749|EG000|Reported Event|Active Coil|"Participants of this arm will receive active rTMS intervention (treatment).~Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS."
10787039|NCT02426749|EG001|Reported Event|Sham|"Participants of this arm will receive sham rTMS intervention (treatment).~Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain."
10787040|NCT02318264|BG000|Baseline|Distal to Proximal Tape, Then Proximal to Distal|"Quadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal by hip.~Kinesio Tape: Elastic tape placed over the skin"
10787041|NCT02318264|BG001|Baseline|Proximal to Distal Tape, Then Distal to Proximal|"Quadriceps muscle taped (Using Kinesio Tape) starting proximal by hip and ending distal by knee.~Kinesio Tape: Elastic tape placed over the skin"
10787042|NCT02318264|BG002|Baseline|Total|Total of all reporting groups
10787043|NCT02318264|FG000|Participant Flow|Distal to Proximal Tape, Then Proximal to Distal|"Participants first received Quadriceps muscle taping (Using Kinesio Tape) starting distal by knee and ending proximal by hip, after a one week washout period, received quadriceps muscle taping starting proximal and ending distal.~Kinesio Tape: Elastic tape placed over the skin"
10787044|NCT02318264|FG001|Participant Flow|Proximal to Distal Tape, Then Distal to Proximal|"Participants first received quadriceps muscle taping (Using Kinesio Tape) starting proximal by hip and ending distal by knee, then after a one week washout period, received quadriceps muscle taping starting distal and ending proximal.~Kinesio Tape: Elastic tape placed over the skin"
10787045|NCT02318264|OG000|Outcome|Distal to Proximal Tape|"Quadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal~Kinesio Tape: Elastic tape placed over the skin"
10787046|NCT02318264|OG001|Outcome|Proximal to Distal Tape|"Quadriceps muscle taped (Using Kinesio Tape) starting proximal by hip and ending distal.~Kinesio Tape: Elastic tape placed over the skin"
10787047|NCT02318264|OG000|Outcome|Distal to Proximal Tape|"Quadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal.~Kinesio Tape: Elastic tape placed over the skin"
10787048|NCT02318264|EG000|Reported Event|Distal to Proximal Tape|"Quadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal by hip.~Kinesio Tape: Elastic tape placed over the skin"
10787049|NCT02318264|EG001|Reported Event|Proximal to Distal Tape|"Quadriceps muscle taped (Using Kinesio Tape) starting proximal by hip and ending distal by knee.~Kinesio Tape: Elastic tape placed over the skin"
10787050|NCT02163694|BG000|Baseline|Veliparib Placebo With Carboplatin and Paclitaxel|Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787051|NCT02163694|BG001|Baseline|Veliparib With Carboplatin and Paclitaxel|Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787052|NCT02163694|BG002|Baseline|Total|Total of all reporting groups
10787053|NCT02163694|FG000|Participant Flow|Veliparib Placebo With Carboplatin and Paclitaxel|Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787054|NCT02163694|FG001|Participant Flow|Veliparib With Carboplatin and Paclitaxel|Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787055|NCT02163694|OG000|Outcome|Veliparib Placebo With Carboplatin and Paclitaxel|Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787056|NCT02163694|OG001|Outcome|Veliparib With Carboplatin and Paclitaxel|Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787057|NCT02163694|EG000|Reported Event|Veliparib Placebo With Carboplatin and Paclitaxel|Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
11241058|NCT02484690|BG000|Baseline|Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)|Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
10787058|NCT02163694|EG001|Reported Event|Veliparib With Carboplatin and Paclitaxel|Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
10787059|NCT01966471|BG000|Baseline|Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane|Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787060|NCT01966471|BG001|Baseline|Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab|Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787061|NCT01966471|BG002|Baseline|Total|Total of all reporting groups
10787062|NCT01966471|FG000|Participant Flow|Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane|Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787063|NCT01966471|FG001|Participant Flow|Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab|Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787064|NCT01966471|OG000|Outcome|Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane|Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787065|NCT01966471|OG001|Outcome|Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab|Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787066|NCT01966471|EG000|Reported Event|Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane|Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787067|NCT01966471|EG001|Reported Event|Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab|Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
10787068|NCT01871220|BG000|Baseline|Concave|Participants were missing a single-rooted tooth on the upper jaw and were randomly-assigned to receive a concave-shaped implant abutment.
10787069|NCT01871220|BG001|Baseline|Divergent|Participants were missing a single-rooted tooth on the upper jaw and were randomly assigned to receive a divergent-shaped implant abutment.
10787070|NCT01871220|BG002|Baseline|Total|Total of all reporting groups
10787071|NCT01871220|FG000|Participant Flow|Divergent Abutment|"Divergent Transition Profile~Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile"
10787072|NCT01871220|FG001|Participant Flow|Concave Abutment|"Concave Transition Profile~Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile."
10787073|NCT01871220|OG000|Outcome|Divergent Abutment|"Divergent Transition Profile~Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile"
10787074|NCT01871220|OG001|Outcome|Concave Abutment|"Concave Transition Profile~Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile."
10787075|NCT01871220|EG000|Reported Event|Divergent Abutment|"Divergent Transition Profile~Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile"
10787076|NCT01871220|EG001|Reported Event|Concave Abutment|"Concave Transition Profile~Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile."
10787077|NCT01825187|BG000|Baseline|ULTRAPRO Mesh|"Patients in this group will be randomized to receive the ULTRAPRO mesh~ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair"
10787078|NCT01825187|BG001|Baseline|3DMAX Mesh|"Patients in this group will be randomized to receive the 3DMAX Mesh~3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair"
11241059|NCT02484690|BG001|Baseline|Arm B: Faricimab, 1.5 mg Q4W|Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
10787079|NCT01825187|BG002|Baseline|Total|Total of all reporting groups
10787080|NCT01825187|FG000|Participant Flow|ULTRAPRO Mesh Group|"Patients in this group will be randomized to receive the ULTRAPRO mesh~ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair"
10787081|NCT01825187|FG001|Participant Flow|3DMAX Mesh Group|"Patients in this group will be randomized to receive the 3DMAX Mesh~3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair"
10802154|NCT02639559|OG001|Outcome|Arm 2: Recipients|-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
10787082|NCT01825187|FG002|Participant Flow|Evaluation of Surgical Residents|"Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes.~Evaluation: To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes."
10787083|NCT01825187|OG000|Outcome|ULTRAPRO Mesh|ULTRAPRO Mesh: Patients randomized to this group received ULTRAPRO Mesh for their hernia repair
10787084|NCT01825187|OG001|Outcome|3DMAX Mesh|3DMAX: Patients randomized to this group received 3DMAX mesh for their hernia repair
10787085|NCT01825187|OG000|Outcome|ULTRAPRO Mesh Group|NASA TLX Surveys were completed by residents who performed hernia repairs for the arm of subjects who received the UltraPro Mesh.
10787086|NCT01825187|OG001|Outcome|3DMAX Mesh Group|NASA TLX Surveys were completed by residents who performed hernia repairs for the arm of subjects who received the 3DMax Mesh.
10787087|NCT01825187|EG000|Reported Event|ULTRAPRO Mesh Group|"Patients in this group will be randomized to receive the ULTRAPRO mesh~ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair"
10787088|NCT01825187|EG001|Reported Event|3DMAX Mesh Group|"Patients in this group will be randomized to receive the 3DMAX Mesh~3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair"
10787089|NCT01825187|EG002|Reported Event|Evaluation of Surgical Residents|"Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes.~Evaluation: To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes."
10802155|NCT02639559|EG000|Reported Event|Arm 1: Donors|-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10^6 CD34+ cells/kg and at least ≥ 2 x 10^6 CD34+ cells/kg from the combined collections.
10802156|NCT02639559|EG001|Reported Event|Arm 2: Recipients|-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
10802157|NCT02569476|BG000|Baseline|Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802158|NCT02569476|FG000|Participant Flow|Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802159|NCT02569476|OG000|Outcome|Part 1: Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated.
10802160|NCT02569476|OG000|Outcome|Part 1: 160 mg BID|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated.
10802161|NCT02569476|OG001|Outcome|Part 1: 320 mg QD|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated.
10802162|NCT02569476|OG000|Outcome|Part 1: Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802163|NCT02569476|OG000|Outcome|Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802164|NCT02569476|OG000|Outcome|Part 2: Zanubrutinib and Obinutuzumab|Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802165|NCT02569476|OG000|Outcome|Part 2: 160 mg BID|Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10802166|NCT02569476|EG000|Reported Event|Zanubrutinib and Obinutuzumab|Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts.
10803768|NCT02134028|OG001|Outcome|Participants From EFC13691: Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10787103|NCT01465334|BG000|Baseline|Treatment Naive|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787104|NCT01465334|BG001|Baseline|Relapsed/Refractory|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787105|NCT01465334|BG002|Baseline|Total|Total of all reporting groups
10787106|NCT01465334|FG000|Participant Flow|Treatment Naive|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787107|NCT01465334|FG001|Participant Flow|Relapsed/Refractory|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787108|NCT01465334|OG000|Outcome|Treatment Naive|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787109|NCT01465334|OG001|Outcome|Relapsed/Refractory|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days):~Induction Part A: Ofatumumab + HDMP 2-4 cycles~Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22~High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy.~Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles~Ofatumumab: 1000 mg IV Day 1~Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study.~Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles~Ofatumumab: 1000 mg IV Day 1 every other cycle~Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787110|NCT01465334|EG000|Reported Event|Treatment Naive|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.~(cycle duration=28 days)~Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B.~Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B.~Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10803769|NCT02134028|EG000|Reported Event|Participants From DRI12544 Study Placebo/Dupilumab|Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10787111|NCT01465334|EG001|Reported Event|Relapsed/Refractory|"Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.~(cycle duration=28 days)~Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3~Participants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B.~Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26~Participants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B.~Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28"
10787112|NCT01307423|BG000|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
10787113|NCT01307423|BG001|Baseline|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787114|NCT01307423|BG002|Baseline|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787115|NCT01307423|BG003|Baseline|Total|Total of all reporting groups
10787116|NCT01307423|FG000|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
10787117|NCT01307423|FG001|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
10787118|NCT01307423|FG002|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
10787119|NCT01307423|FG003|Participant Flow|Placebo/ Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast twice daily in the active treatment phase.
10787120|NCT01307423|FG004|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast twice daily in the active treatment phase.
10787121|NCT01307423|FG005|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast twice daily in the active treatment phase.
10787122|NCT01307423|FG006|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast twice daily in the active treatment phase.
10787123|NCT01307423|FG007|Participant Flow|Placebo/Apremilast 20 mg [Long-Term Safety Phase (LTSP)]|Participants initially randomized to placebo tablets twice daily during the 24-week placebo-controlled phase were re-randomized to 20 mg apremilast tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg tablets twice daily in active treatment / long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose).
10787124|NCT01307423|FG008|Participant Flow|Placebo/Apremilast 30 mg (Long-Term Safety Phase)|Participants initially randomized to placebo tablets BID during the 24-week placebo-controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg tablets twice daily in the active treatment / long-term safety phase.
10787125|NCT01307423|OG000|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
10787126|NCT01307423|OG001|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787127|NCT01307423|OG002|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787128|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787129|NCT01307423|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase.
10787130|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
10787131|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive apremilast 20 mg tablets twice daily.
10787132|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily in the 24-week placebo-controlled phase.
10787133|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive apremilast 20 mg tablets twice daily in the 24-week placebo-controlled phase.
10787134|NCT01307423|OG001|Outcome|Apremilast 20 mg|Participants initially randomized to receive apremilast 20 mg tablets twice daily in the 24-week placebo-controlled phase..
10787135|NCT01307423|OG002|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
10787136|NCT01307423|OG000|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
10787137|NCT01307423|OG001|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
10787138|NCT01307423|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
10787139|NCT01307423|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
10787140|NCT01307423|OG002|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
10787141|NCT01307423|OG000|Outcome|Placebo/Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
10787142|NCT01307423|OG001|Outcome|Placebo/Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
10787143|NCT01307423|OG000|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily
10787144|NCT01307423|OG003|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
10787145|NCT01307423|OG001|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily
10787146|NCT01307423|OG000|Outcome|Apremilast 20 mg (Pre-Switch)|Participants who received 20 mg apremilast tablets twice daily, regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only the TEAEs that occurred during apremilast 20 mg BID were counted.
10787147|NCT01307423|OG001|Outcome|Apremilast 20/30 mg (Post-Switch)|Participants who switched from apremilast 20 mg tablets twice daily to apremilast 30 mg twice daily. Only the TEAEs that occurred during the apremilast 30 mg treatment were included.
10787148|NCT01307423|OG002|Outcome|Apremilast 30 mg|Participants who received apremilast 30 mg twice daily regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
10787149|NCT01307423|EG000|Reported Event|Weeks 0-24: Placebo (Placebo-Controlled Phase)|Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
10787150|NCT01307423|EG001|Reported Event|Weeks 0-24: Apremilast 20 mg|Participants received 20 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
10787151|NCT01307423|EG002|Reported Event|Weeks 0-24: Apremilast 30 mg|Participants received 30 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.
10787152|NCT01307423|EG003|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20 mg|Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.
10787153|NCT01307423|EG004|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg|Participants who switched from apremilast 20 mg twice daily to apremilast 30 mg BID. Only the TEAEs that occurred during apremilast 30 mg twice daily treatment were included.
10787154|NCT01307423|EG005|Reported Event|APR Exposure Period Up to 5 Years: Apremilast 30 mg|Participants who received apremilast 30 mg twice daily throughout the study regardless of when the apremilast exposure started (at Week 0, 16, or 24).
10787155|NCT01030575|BG000|Baseline|Inositol Low Volume|"10 mg/kg/day Intravenous inositol 5%~Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787156|NCT01030575|BG001|Baseline|Inositol Mid-level Volume|"40 mg/kg/day Intravenous inositol 5%~Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787157|NCT01030575|BG002|Baseline|Inositol High Volume|"80 mg/kg/day Intravenous inositol 5%~Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787158|NCT01030575|BG003|Baseline|Placebo|"Glucose 5% given in volumes equal to that of the comparator drug~Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug"
10787159|NCT01030575|BG004|Baseline|Total|Total of all reporting groups
10787160|NCT01030575|FG000|Participant Flow|Inositol Low Volume|"10 mg/kg/day Intravenous inositol 5%~Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787161|NCT01030575|FG001|Participant Flow|Inositol Mid-level Volume|"40 mg/kg/day Intravenous inositol 5%~Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787162|NCT01030575|FG002|Participant Flow|Inositol High Volume|"80 mg/kg/day Intravenous inositol 5%~Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787163|NCT01030575|FG003|Participant Flow|Placebo|"Glucose 5% given in volumes equal to that of the comparator drug~Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug"
10787164|NCT01030575|OG000|Outcome|PK Population|A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model.
10787165|NCT01030575|OG000|Outcome|Inositol Low Volume|"10 mg/kg/day Intravenous inositol 5%~Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787166|NCT01030575|OG001|Outcome|Inositol Mid-level Volume|"40 mg/kg/day Intravenous inositol 5%~Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787167|NCT01030575|OG002|Outcome|Inositol High Volume|"80 mg/kg/day Intravenous inositol 5%~Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787168|NCT01030575|OG003|Outcome|Placebo|"Glucose 5% given in volumes equal to that of the comparator drug~Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug"
10787169|NCT01030575|EG000|Reported Event|Inositol Low Volume|"10 mg/kg/day Intravenous inositol 5%~Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787170|NCT01030575|EG001|Reported Event|Inositol Mid-level Volume|"40 mg/kg/day Intravenous inositol 5%~Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
11382322|NCT01168219|OG000|Outcome|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
11382323|NCT01168219|EG000|Reported Event|Treatment (Chemotherapy and Transplant)|"REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).~TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).~CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1."
11382324|NCT01145495|BG000|Baseline|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
11382325|NCT01145495|FG000|Participant Flow|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~>~> rituximab: Given IV~>~> lenalidomide: Given orally"
11382326|NCT01145495|OG000|Outcome|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
11382327|NCT01145495|EG000|Reported Event|Treatment (Lenalidomide, Rituximab)|lenalidomide: Given orally
11382328|NCT01142388|BG000|Baseline|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
11382329|NCT01142388|BG001|Baseline|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
11382330|NCT01142388|BG002|Baseline|Total|Total of all reporting groups
11382331|NCT01142388|FG000|Participant Flow|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
11382332|NCT01142388|FG001|Participant Flow|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
11382333|NCT01142388|OG000|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
11382334|NCT01142388|OG001|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
11382335|NCT01142388|EG000|Reported Event|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
11382336|NCT01142388|EG001|Reported Event|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
11382337|NCT01134614|BG000|Baseline|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
11382338|NCT01134614|BG001|Baseline|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
11382339|NCT01134614|BG002|Baseline|Total|Total of all reporting groups
11382340|NCT01134614|FG000|Participant Flow|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
10787171|NCT01030575|EG002|Reported Event|Inositol High Volume|"80 mg/kg/day Intravenous inositol 5%~Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes"
10787172|NCT01030575|EG003|Reported Event|Placebo|"Glucose 5% given in volumes equal to that of the comparator drug~Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug"
10787173|NCT00911183|BG000|Baseline|Arm I (R-COP Regimen)|"Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787174|NCT00911183|BG001|Baseline|Arm II (R-COPY Regimen)|"Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~liposome-encapsulated doxorubicin citrate: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787175|NCT00911183|BG002|Baseline|Total|Total of all reporting groups
10787176|NCT00911183|FG000|Participant Flow|Arm I (R-COP Regimen)|"Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787177|NCT00911183|FG001|Participant Flow|Arm II (R-COPY Regimen)|"Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~liposome-encapsulated doxorubicin citrate: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787178|NCT00911183|OG000|Outcome|Arm I (R-COP Regimen)|"Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787179|NCT00911183|OG001|Outcome|Arm II (R-COPY Regimen)|"Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~liposome-encapsulated doxorubicin citrate: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787180|NCT00911183|EG000|Reported Event|Arm I (R-COP Regimen)|"Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787181|NCT00911183|EG001|Reported Event|Arm II (R-COPY Regimen)|"Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses.~filgrastim: Given subcutaneously~pegfilgrastim: Given subcutaneously~rituximab: Given IV~cyclophosphamide: Given IV~liposome-encapsulated doxorubicin citrate: Given IV~prednisone: Given orally~vincristine sulfate: Given IV"
10787182|NCT00655876|BG000|Baseline|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
10787183|NCT00655876|BG001|Baseline|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
10787184|NCT00655876|BG002|Baseline|Total|Total of all reporting groups
10787185|NCT00655876|FG000|Participant Flow|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
10787186|NCT00655876|FG001|Participant Flow|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
10787187|NCT00655876|OG000|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
10787188|NCT00655876|OG001|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
10787189|NCT00655876|EG000|Reported Event|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, and cisplatin, a
10787190|NCT00655876|EG001|Reported Event|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
10787191|NCT00602576|BG000|Baseline|Arm A|"Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787192|NCT00602576|BG001|Baseline|Arm B|"Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787193|NCT00602576|BG002|Baseline|Arm C|"Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787194|NCT00602576|BG003|Baseline|Arm D|"Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787195|NCT00602576|BG004|Baseline|Total|Total of all reporting groups
10787196|NCT00602576|FG000|Participant Flow|Arm A|"Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787197|NCT00602576|FG001|Participant Flow|Arm B|"Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787198|NCT00602576|FG002|Participant Flow|Arm C|"Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787199|NCT00602576|FG003|Participant Flow|Arm D|"Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787200|NCT00602576|OG000|Outcome|Arm A|"Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787201|NCT00602576|OG001|Outcome|Arm B|"Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787202|NCT00602576|OG002|Outcome|Arm C|"Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787203|NCT00602576|OG003|Outcome|Arm D|"Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787204|NCT00602576|EG000|Reported Event|Arm A|"Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787205|NCT00602576|EG001|Reported Event|Arm B|"Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787206|NCT00602576|EG002|Reported Event|Arm C|"Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787207|NCT00602576|EG003|Reported Event|Arm D|"Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33.~sorafenib tosylate: Given orally~temozolomide: Given orally"
10787208|NCT00265941|BG000|Baseline|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
10787209|NCT00265941|BG001|Baseline|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
10787210|NCT00265941|BG002|Baseline|Total|Total of all reporting groups
11194736|NCT02153905|BG000|Baseline|Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194737|NCT02153905|BG001|Baseline|Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194738|NCT02153905|BG002|Baseline|Total|Total of all reporting groups
10787211|NCT00265941|FG000|Participant Flow|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
10787212|NCT00265941|FG001|Participant Flow|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
10787213|NCT00265941|OG000|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
10787214|NCT00265941|OG001|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
10787215|NCT00265941|OG000|Outcome|Low EGFR|Less than 80% EGFR
10787216|NCT00265941|OG001|Outcome|High EGFR|Greater than or equal to 80% EGFR
10787217|NCT00265941|OG000|Outcome|Low PET SUVmax|Less than or equal to median pretreatment PET SUVmax
10787218|NCT00265941|OG001|Outcome|High PET SUVmax|Greater than median pretreatment PET SUVmax
10787219|NCT00265941|OG000|Outcome|Clinical CR + Negative PET|Clinical nodal complete response; negative post-treatment PET/CT scan
10787220|NCT00265941|OG001|Outcome|No Clinical CR + Negative PET|Did not have clinical nodal complete response; negative post-treatment PET/CT scan
10787221|NCT00265941|OG002|Outcome|Clinical CR + Positive PET|Clinical nodal complete response; positive post-treatment PET/CT scan
10787222|NCT00265941|OG003|Outcome|No Clinical CR + Positive PET|No clinical nodal complete response; positive post-treatment PET/CT scan
10787223|NCT00265941|EG000|Reported Event|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
10787224|NCT00265941|EG001|Reported Event|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
10787225|NCT00114140|BG000|Baseline|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787226|NCT00114140|FG000|Participant Flow|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787227|NCT00114140|OG000|Outcome|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787228|NCT00114140|OG000|Outcome|Temozolomide + Radiation Therapy (RT) - Methylated|Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with methylated status
10787229|NCT00114140|OG001|Outcome|Temozolomide + Radiation Therapy (RT) - Unmethylated|Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status
10787230|NCT00114140|OG000|Outcome|Temozolomide + Radiation Therapy (RT) at Baseline|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787231|NCT00114140|OG001|Outcome|Temozolomide + Radiation Therapy (RT) at 6 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787232|NCT00114140|OG002|Outcome|Temozolomide + Radiation Therapy (RT) at 12 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787233|NCT00114140|OG000|Outcome|Temozolomide + Radiation Therapy (RT) at 6 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787234|NCT00114140|OG001|Outcome|Temozolomide + Radiation Therapy (RT) at 12 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787235|NCT00114140|EG000|Reported Event|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
10787236|NCT00047008|BG000|Baseline|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
10787237|NCT00047008|BG001|Baseline|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
10787238|NCT00047008|BG002|Baseline|Total|Total of all reporting groups
10787239|NCT00047008|FG000|Participant Flow|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
10787240|NCT00047008|FG001|Participant Flow|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
11241060|NCT02484690|BG002|Baseline|Arm C: Faricimab, 6 mg Q4W|Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
10787241|NCT00047008|OG000|Outcome|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
10787242|NCT00047008|OG001|Outcome|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
10787243|NCT00047008|EG000|Reported Event|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
10787244|NCT00047008|EG001|Reported Event|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
10802167|NCT02549209|BG000|Baseline|Investigational Treatment|"Subjects with no prior therapy:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 175mg/m2~Carboplatin administered at an AUC of 6~Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 135mg/m2~Carboplatin administered at an AUC of 5~Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects~Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.~Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.~Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.~Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes."
10803770|NCT02134028|EG001|Reported Event|Participants From DRI12544 Study Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
11241061|NCT02484690|BG003|Baseline|Arm D: Faricimab, 6 mg Every 4-8 Weeks|Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
10787245|NCT04701138|BG000|Baseline|Dietary Supplement|"All subjects will receive the intervention (SPM Active Supplement)~SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg."
10787246|NCT04701138|FG000|Participant Flow|Dietary Supplement|"All subjects will receive the intervention (SPM Active Supplement)~SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg."
10787247|NCT04701138|OG000|Outcome|Dietary Supplement|"All subjects will receive the intervention (SPM Active Supplement)~SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg."
10787248|NCT04701138|EG000|Reported Event|Dietary Supplement|"All subjects will receive the intervention (SPM Active Supplement)~SPM Active: Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg."
10787249|NCT04392583|BG000|Baseline|Device: ENTACT Septal Staple|"Septoplasty~ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery."
10787250|NCT04392583|FG000|Participant Flow|Device: ENTACT Septal Staple|"Septoplasty~ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery."
10787251|NCT04392583|OG000|Outcome|Device: ENTACT Septal Staple|"Septoplasty~ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery."
10787252|NCT04392583|EG000|Reported Event|Device: ENTACT Septal Staple|"Septoplasty~ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery."
10787253|NCT04332640|BG000|Baseline|Veritas Vision System|Next Generation Phaco System
10787254|NCT04332640|FG000|Participant Flow|Veritas Vision System|Next Generation Phaco System
10787255|NCT04332640|OG000|Outcome|Veritas Vision System|n/N (Eyes with ratings of 4 or 5/eyes treated)
10787256|NCT04332640|EG000|Reported Event|Veritas Vision System|Next Generation Phaco System
10787257|NCT04326439|BG000|Baseline|Aflac-AML Low Risk Patients|"Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype~Induction II: Mitoxantrone/AraC~Intensification I: AraC/Etoposide~Intensification II: HD AraC/Asparaginase"
10787258|NCT04326439|BG001|Baseline|Aflac-AML High Risk Patients|"Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype^ Induction II: Mitoxantrone/AraC^ Intensification:* AraC/Etoposide^ OR HD AraC/Asparaginase^ Allogenic HSCT~^If has FLT3-ITD mutation, Sorafenib is added~* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy"
10787259|NCT04326439|BG002|Baseline|Total|Total of all reporting groups
10787260|NCT04326439|FG000|Participant Flow|Aflac-AML Low Risk Patients|"Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype~Induction II: Mitoxantrone/AraC~Intensification I: AraC/Etoposide~Intensification II: HD AraC/Asparaginase"
10787261|NCT04326439|FG001|Participant Flow|Aflac-AML High Risk Patients|"Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype^ Induction II: Mitoxantrone/AraC^ Intensification:* AraC/Etoposide^ OR HD AraC/Asparaginase^ Allogenic HSCT~^If has FLT3-ITD mutation, Sorafenib is added~* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy"
10787262|NCT04326439|OG000|Outcome|Aflac-AML Low Risk Patients|"Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype~Induction II: Mitoxantrone/AraC~Intensification I: AraC/Etoposide~Intensification II: HD AraC/Asparaginase"
10787263|NCT04326439|OG001|Outcome|Aflac-AML High Risk Patients|"Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.~Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype^ Induction II: Mitoxantrone/AraC^ Intensification:* AraC/Etoposide^ OR HD AraC/Asparaginase^ Allogenic HSCT~^If has FLT3-ITD mutation, Sorafenib is added~* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy"
10787264|NCT04326439|OG000|Outcome|Induction I With GO|Patients with CC genotype received Induction 1 AraC/Daunorubicin/Etoposide (10+3+5) with Gemtuzumab ozogamicin (GO)
10787265|NCT04326439|OG001|Outcome|Induction I Without GO|Patients without CC genotype received Induction 1 AraC/Daunorubicin/Etoposide (10+3+5)
10787266|NCT04326439|OG000|Outcome|Patients Who Are MRD Negative|Patients who are MRD negative but lack high or low risk molecular and cytogenetic features, defined as time from end of first course of therapy to death or relapse.
10787267|NCT04326439|EG000|Reported Event|Induction I|"Participants in this group received AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype^ Patients were classified into risk groups following Induction I~^If has FLT3-ITD mutation, Sorafenib is added"
10787268|NCT04326439|EG001|Reported Event|Low Risk - Induction II|Participants in this group received Mitoxantrone/AraC
10787269|NCT04326439|EG002|Reported Event|High Risk - Induction II|"Participants in this group received Mitoxantrone/AraC^~^If has FLT3-ITD mutation, Sorafenib is added"
10787270|NCT04326439|EG003|Reported Event|Low Risk - Intensification I|Participants in this group received AraC/Etoposide
10787271|NCT04326439|EG004|Reported Event|Low Risk - Intensification II|Participants in this group received HD AraC/Asparaginase
10787272|NCT04188730|BG000|Baseline|All Study Participants|16 individuals were enrolled in this crossover study. Each subject was eligible to participate in all 3 Treatment Groups (Treatment A, Treatment B, Treatment C).
10787273|NCT04188730|FG000|Participant Flow|Sequence 1: Treatment B, Treatment A, Treatment C|Treatment B = LUCEMYRA tablets - fasted conditions Treatment A = Lofexidine granules - fasted conditions Treatment C = Lofexidine granules - fed conditions Participants in Sequence 1 were first administered (Period 1) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C).
10787274|NCT04188730|FG001|Participant Flow|Sequence 2: Treatment B, Treatment C, Treatment A|Treatment B = LUCEMYRA tablets - fasted conditions Treatment C = Lofexidine granules - fed conditions Treatment A = Lofexidine granules - fasted conditions Participants in Sequence 2 were first administered (Period 1) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A).
10787275|NCT04188730|FG002|Participant Flow|Sequence 3: Treatment A, Treatment C, Treatment B|Treatment A = Lofexidine granules - fasted conditions Treatment C = Lofexidine granules - fed conditions Treatment B = LUCEMYRA tablets - fasted conditions Participants in Sequence 3 were first administered (Period 1) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B).
10787276|NCT04188730|FG003|Participant Flow|Sequence 4: Treatment C, Treatment A, Treatment B|"Treatment C = Lofexidine granules - fed conditions Treatment A = Lofexidine granules - fasted conditions Treatment B = LUCEMYRA tablets - fasted conditions~Participants in Sequence 4 were first administered (Period 1) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B)."
10787277|NCT04188730|OG000|Outcome|Treatment A: Lofexidine Granules - Fasted Conditions|"Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.~Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution."
10787278|NCT04188730|OG001|Outcome|Treatment B: LUCEMYRA Tablets - Fasted Conditions|"Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours~LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets."
10787279|NCT04188730|OG002|Outcome|Treatment C: Lofexidine Granules - Fed Conditions|"Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.~Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution."
10787280|NCT04188730|OG000|Outcome|Treatment A: Lofexidine Granules - Fasted Conditions|Participants were administer one-0.36 mg dose of Lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
10787281|NCT04188730|OG001|Outcome|Treatment B: LUCEMYRA Tablets - Fasted Conditions|Participants will first be administered one-0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours.
10787282|NCT04188730|OG002|Outcome|Treatment C: Lofexidine Granules - Fed Conditions|Participants will first be administered one-0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
10787283|NCT04188730|EG000|Reported Event|Treatment A: Lofexidine Granules - Fasted Conditions|Participants were administer one-0.36 mg dose of Lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
10787284|NCT04188730|EG001|Reported Event|Treatment B: LUCEMYRA Tablets - Fasted Conditions|Participants will first be administered one-0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours.
10787285|NCT04188730|EG002|Reported Event|Treatment C: Lofexidine Granules - Fed Conditions|Participants will first be administered one-0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
10787286|NCT04003142|BG000|Baseline|Double-blind Period: Placebo|Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
10787287|NCT04003142|BG001|Baseline|Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
11241062|NCT02484690|BG004|Baseline|Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W|Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
11241063|NCT02484690|BG005|Baseline|Total|Total of all reporting groups
11241064|NCT02484690|FG000|Participant Flow|Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)|Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
11241065|NCT02484690|FG001|Participant Flow|Arm B: Faricimab, 1.5 mg Q4W|Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
11382341|NCT01134614|FG001|Participant Flow|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
11382342|NCT01134614|OG000|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
11382343|NCT01134614|OG001|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
11382344|NCT01134614|EG000|Reported Event|Arm A (Ipilimumab and Sargramostim)|ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
11382345|NCT01134614|EG001|Reported Event|Arm B (Ipilimumab)|ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
11382346|NCT01116648|BG000|Baseline|Phase 1 Dose Level 0 (3 Participants)|"Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.~This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause."
11382347|NCT01116648|BG001|Baseline|Phase 1 Dose Level 1 (3 Participants)|"Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.~This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause."
11382348|NCT01116648|BG002|Baseline|Phase 1 Dose Level 2 (7 Participants)|"Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.~This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause."
11194739|NCT02153905|FG000|Participant Flow|Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194740|NCT02153905|FG001|Participant Flow|Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194741|NCT02153905|OG000|Outcome|Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194742|NCT02153905|OG001|Outcome|Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194743|NCT02153905|EG000|Reported Event|Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
10787288|NCT04003142|BG002|Baseline|Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to Week 52 during extension treatment period.
11194744|NCT02153905|EG001|Reported Event|Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2)|"Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MAGE-A3- A1 transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Aldesleukin: Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).~Fludarabine: Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR): Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
11194745|NCT02153918|BG000|Baseline|Vaccine Plus Booster Shots|"PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC~PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules."
11241066|NCT02484690|FG002|Participant Flow|Arm C: Faricimab, 6 mg Q4W|Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
10787289|NCT04003142|BG003|Baseline|Total|Total of all reporting groups
10787290|NCT04003142|FG000|Participant Flow|Double-blind Period: Placebo|Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
10787291|NCT04003142|FG001|Participant Flow|Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
10787292|NCT04003142|FG002|Participant Flow|Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg orally, QD from week 13 up to Week 52 during extension treatment period.
10787293|NCT04003142|FG003|Participant Flow|Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787294|NCT04003142|FG004|Participant Flow|Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787295|NCT04003142|OG000|Outcome|Double-blind Period: Placebo|Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
10787296|NCT04003142|OG001|Outcome|Double-blind Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.
10787297|NCT04003142|OG002|Outcome|Double-blind Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.
10787298|NCT04003142|OG000|Outcome|Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
10787299|NCT04003142|OG001|Outcome|Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to Week 52 during extension treatment period.
10787300|NCT04003142|OG002|Outcome|Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787301|NCT04003142|OG003|Outcome|Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787302|NCT04003142|OG001|Outcome|Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
10787303|NCT04003142|OG002|Outcome|Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to Week 52 during extension treatment period.
10787304|NCT04003142|OG003|Outcome|Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787305|NCT04003142|OG004|Outcome|Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787306|NCT04003142|EG000|Reported Event|Double-blind Period: Placebo|Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
10787307|NCT04003142|EG001|Reported Event|Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg|Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
10787308|NCT04003142|EG002|Reported Event|Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg|Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to Week 52 during extension treatment period.
10787309|NCT04003142|EG003|Reported Event|Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787310|NCT04003142|EG004|Reported Event|Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg|Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
10787311|NCT03909607|BG000|Baseline|SDK 0.75 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k~Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg"
10787312|NCT03909607|BG001|Baseline|SDK 1.0 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k~Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg"
10787313|NCT03909607|BG002|Baseline|SDK 1.5 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k~Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg"
10787314|NCT03909607|BG003|Baseline|Total|Total of all reporting groups
10787315|NCT03909607|FG000|Participant Flow|SDK 0.75 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k~Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg"
10787316|NCT03909607|FG001|Participant Flow|SDK 1.0 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k~Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg"
10787317|NCT03909607|FG002|Participant Flow|SDK 1.5 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k~Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg"
10787318|NCT03909607|OG000|Outcome|SDK 0.75 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k~Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg"
10787319|NCT03909607|OG001|Outcome|SDK 1.0 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k~Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg"
10787320|NCT03909607|OG002|Outcome|SDK 1.5 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k~Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg"
10787321|NCT03909607|EG000|Reported Event|SDK 0.75 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k~Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg"
10787322|NCT03909607|EG001|Reported Event|SDK 1.0 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k~Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg"
10787323|NCT03909607|EG002|Reported Event|SDK 1.5 mg/kg|"The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k~Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg"
10787324|NCT03586050|BG000|Baseline|Microwave Ablation|Each participant underwent microwave ablation of a liver tumor (Hepatocellular Carcinoma (HCC)) at a single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
10787325|NCT03586050|FG000|Participant Flow|Microwave Ablation|Each participant underwent microwave ablation of a liver tumor (Hepatocellular Carcinoma (HCC)) at a single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
10787326|NCT03586050|OG000|Outcome|Microwave Ablation|Each participant underwent microwave ablation of a liver tumor (Hepatocellular Carcinoma (HCC)) at a single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
10787327|NCT03586050|EG000|Reported Event|Microwave Ablation|Each participant underwent microwave ablation of a liver tumor (Hepatocellular Carcinoma (HCC)) at a single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
10787328|NCT03430531|BG000|Baseline|Sphenopalatine Ganglion Block|"Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.~Lidocaine: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes."
10787329|NCT03430531|FG000|Participant Flow|Sphenopalatine Ganglion Block|"Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.~Lidocaine: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes."
10787330|NCT03430531|OG000|Outcome|Sphenopalatine Ganglion Block|"Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.~Lidocaine: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes."
10787331|NCT03430531|EG000|Reported Event|Sphenopalatine Ganglion Block|"Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.~Lidocaine: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes."
10787332|NCT03402841|BG000|Baseline|Olaparib|"Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM.~Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria."
10787333|NCT03402841|FG000|Participant Flow|Olaparib|"Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM.~Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria."
11382349|NCT01116648|BG003|Baseline|Phase 1 Dose Level 3 (6 Participants)|"Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.~This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause."
11382350|NCT01116648|BG004|Baseline|Phase 1 Expansion at MTD (9 Participants)|"Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.~This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause."
11382351|NCT01116648|BG005|Baseline|Phase 2 - Olaparib Alone|Assess the efficacy (as measured by progression-free survival (PFS) ) of olaparib alone in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
11382352|NCT01116648|BG006|Baseline|Phase 2 - Cediranib/Olaparib|Assess the efficacy (as measured by progression-free survival (PFS) ) of the combination of cediranib and olaparib in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
11382353|NCT01116648|BG007|Baseline|Phase 1-T Dose Level 0-TA|Cediranib 30mg PO daily; Olaparib (tablet) 150mg PO BID
11382354|NCT01116648|BG008|Baseline|Phase 1-T Dose Level 1-TA|Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID
11382355|NCT01116648|BG009|Baseline|Phase 1-T Dose Level 2-TA|Cediranib 30mg PO daily; Olaparib (tablet) 250mgPO BID
11382356|NCT01116648|BG010|Baseline|Phase 1-T Dose Level 0-TB|Cediranib 20mg PO daily; Olaparib (tablet) 200mg PO BID
11382357|NCT01116648|BG011|Baseline|Phase 1-T Dose Level 1-TB|Cediranib 20mg PO daily; Olaparib (tablet) 250mg PO BID
11382358|NCT01116648|BG012|Baseline|Phase 1-T Dose Level 2-TB|Cediranib 20mg PO daily; Olaparib (tablet) 300mg PO BID
11382359|NCT01116648|BG013|Baseline|Phase 1-T PKOlap Expansion|Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID; 7-day lead-in of single-agent olaparib
11382360|NCT01116648|BG014|Baseline|Phase 1-T PKCed Expansion|Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID; 7-day lead-in of single-agent cediranib
11382361|NCT01116648|BG015|Baseline|Total|Total of all reporting groups
11382362|NCT01116648|FG000|Participant Flow|Dose Level 0 (20mg Ced+100mg Olap)|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382363|NCT01116648|FG001|Participant Flow|Dose Level 1 (20mg Ced + 200mg Olap)|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382364|NCT01116648|FG002|Participant Flow|Dose Level 2 (30mg Ced + 200mg Olap)|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382365|NCT01116648|FG003|Participant Flow|Dose Level 3 (30mg Ced + 400mg Olap)|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382366|NCT01116648|FG004|Participant Flow|Expansion Cohort at MTD|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382367|NCT01116648|FG005|Participant Flow|Phase 2 - Olaparib Alone|Phase 2 - a total of 46 patients were randomized to receive olaparib alone.
11382368|NCT01116648|FG006|Participant Flow|Phase 2 - Cediranib/Olaparib|Phase 2 - a total of 44 patients were randomized to receive cediranib and olaparib.
11382369|NCT01116648|FG007|Participant Flow|Phase 1-T Dose Level 0-TA|Cediranib 30mg PO daily; Olaparib (tablet) 150mg PO BID
11382370|NCT01116648|FG008|Participant Flow|Phase 1-T Dose Level 1-TA|Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID
11382371|NCT01116648|FG009|Participant Flow|Phase 1-T Dose Level 2-TA|Cediranib 30mg PO daily; Olaparib (tablet) 250mg PO BID
11382372|NCT01116648|FG010|Participant Flow|Phase 1-T Dose Level 0-TB|Cediranib 20mg PO daily; Olaparib (tablet) 200mg PO BID
11382373|NCT01116648|FG011|Participant Flow|Phase 1-T Dose Level 1-TB|Cediranib 20mg PO daily; Olaparib (tablet) 250 mg PO BID
11382374|NCT01116648|FG012|Participant Flow|Phase 1-T Dose Level 2-TB|Cediranib 20mg PO daily; Olaparib (tablet) 300mg PO BID
11382375|NCT01116648|FG013|Participant Flow|Phase 1-T PKOlap Expansion|Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single-agent olaparib
11382376|NCT01116648|FG014|Participant Flow|Phase 1-T PKCed Expansion|Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single agent cediranib
11382377|NCT01116648|OG000|Outcome|Level 0|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
11382378|NCT01116648|OG001|Outcome|Level 1|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
10787334|NCT03402841|OG000|Outcome|Olaparib|"Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM.~Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria."
10787335|NCT03402841|EG000|Reported Event|Olaparib|"Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM.~Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria."
10787336|NCT03383666|BG000|Baseline|PulseRider Aneurysm Neck Reconstruction Device|Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
10787337|NCT03383666|FG000|Participant Flow|PulseRider Aneurysm Neck Reconstruction Device|Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
10787338|NCT03383666|OG000|Outcome|PulseRider Aneurysm Neck Reconstruction Device|Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
10787339|NCT03383666|EG000|Reported Event|PulseRider Aneurysm Neck Reconstruction Device|Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
10787340|NCT03299049|BG000|Baseline|CAB LA + RPV LA Q8W|Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
10787341|NCT03299049|BG001|Baseline|CAB LA + RPV LA Q4W|Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
10787342|NCT03299049|BG002|Baseline|Total|Total of all reporting groups
10787343|NCT03299049|FG000|Participant Flow|CAB LA + RPV LA Q8W|Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
10787344|NCT03299049|FG001|Participant Flow|CAB LA + RPV LA Q4W|Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
10787345|NCT03299049|OG000|Outcome|CAB LA + RPV LA Q8W|Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
10787346|NCT03299049|OG001|Outcome|CAB LA + RPV LA Q4W|Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
10787347|NCT03299049|OG000|Outcome|CAB LA + RPV LA Q4W|Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
10787348|NCT03299049|OG000|Outcome|CAB LA Q8W|Participants in this arm received 2 x 3ml CAB LA injections at week 4b and 2 x 3 ml CAB LA injections Q8W thereafter
10787349|NCT03299049|OG001|Outcome|CAB LA Q4W|Participants in this arm received 2 x 3ml CAB LA injections at week 4b and 2 x 2 ml CAB LA injections Q4W thereafter
10787350|NCT03299049|OG000|Outcome|RPV LA Q8W|Participants in this arm received 2 x 3ml RPV LA injections at week 4b and 2 x 3 ml RPV LA injections Q8W thereafter
10787351|NCT03299049|OG001|Outcome|RPV LA Q4W|Participants in this arm received 2 x 3ml RPV LA injections at week 4b and 2 x 2 ml RPV LA injections Q4W thereafter
10787352|NCT03299049|OG000|Outcome|CAB LA|Participants in this arm received CAB LA 600 mg Q8W and 400 mg Q4W through Week 48
10787353|NCT03299049|OG001|Outcome|RPV LA|Participants in this arm received RPV LA 900 mg Q8W and 600 mg Q4W through Week 48
10787354|NCT03299049|EG000|Reported Event|CAB LA + RPV LA Q8W|Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
10787355|NCT03299049|EG001|Reported Event|CAB LA + RPV LA Q4W|Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
10787356|NCT03219333|BG000|Baseline|Enfortumab Vedotin - Cohort 1|Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787357|NCT03219333|BG001|Baseline|Enfortumab Vedotin - Cohort 2|Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787358|NCT03219333|BG002|Baseline|Total|Total of all reporting groups
10787359|NCT03219333|FG000|Participant Flow|Enfortumab Vedotin - Cohort 1|Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787360|NCT03219333|FG001|Participant Flow|Enfortumab Vedotin - Cohort 2|Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787361|NCT03219333|OG000|Outcome|Enfortumab Vedotin - Cohort 1|Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787362|NCT03219333|OG001|Outcome|Enfortumab Vedotin - Cohort 2|Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787363|NCT03219333|EG000|Reported Event|Enfortumab Vedotin - Cohort 1|Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787364|NCT03219333|EG001|Reported Event|Enfortumab Vedotin - Cohort 2|Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10787365|NCT02987543|BG000|Baseline|Cohort A Olaparib 300mg bd|2x150mg film-coated tablets
10787366|NCT02987543|BG001|Baseline|Cohort A Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787367|NCT02987543|BG002|Baseline|Cohort B Olaparib 300mg bd|2x150mg film-coated tablets
10787368|NCT02987543|BG003|Baseline|Cohort B Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787369|NCT02987543|BG004|Baseline|Total|Total of all reporting groups
10787370|NCT02987543|FG000|Participant Flow|Cohort A Olaparib 300mg bd|2x150mg film-coated tablets
10787371|NCT02987543|FG001|Participant Flow|Cohort A Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787372|NCT02987543|FG002|Participant Flow|Cohort B Olaparib 300mg bd|2x150mg film-coated tablets
10787373|NCT02987543|FG003|Participant Flow|Cohort B Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787374|NCT02987543|OG000|Outcome|Cohort A Olaparib 300mg bd|2x150mg film-coated tablets
10787375|NCT02987543|OG001|Outcome|Cohort A Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787376|NCT02987543|EG000|Reported Event|Cohort A+B Olaparib 300mg bd|2x150mg film-coated tablets
10787377|NCT02987543|EG001|Reported Event|Cohort A+B Investigators Choice of NHA|either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
10787378|NCT02908685|BG000|Baseline|Part 1 Group A Cohort 1: Adolescents and Adults (3 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed and Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787379|NCT02908685|BG001|Baseline|Part 1 Group A Cohort 2: Adolescents and Adults (5 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed and Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787380|NCT02908685|BG002|Baseline|Part 1 Group A Cohort 1: Adolescents and Adults (Placebo)|Adolescent and adult participants aged 12-25 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to their cohort risdiplam dose (i.e. 3 mg). After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787381|NCT02908685|BG003|Baseline|Part 1 Group A Cohort 2: Adolescents and Adults (Placebo)|Adolescent and adult participants aged 12-25 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to their cohort risdiplam dose (i.e. 5 mg). After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787382|NCT02908685|BG004|Baseline|Part 1 Group B Cohort 1: Children (0.02 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. During the placebo-controlled period, participants escalated to 0.05 mg/kg and then to 0.15 mg/kg in two steps. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787383|NCT02908685|BG005|Baseline|Part 1 Group B Cohort 2: Children (0.05 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. During the placebo-controlled period, participants escalated to 0.15 mg/kg in one step. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787384|NCT02908685|BG006|Baseline|Part 1 Group B Cohort 3: Children (0.25 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787385|NCT02908685|BG007|Baseline|Part 1 Group B Cohort 1: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to the final 0.15 mg/kg cohort risdiplam dose. After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787386|NCT02908685|BG008|Baseline|Part 1 Group B Cohort 2: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to the final 0.15 mg/kg cohort risdiplam dose. After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787387|NCT02908685|BG009|Baseline|Part 1 Group B Cohort 3: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787388|NCT02908685|BG010|Baseline|Part 2: Risdiplam|Participants aged 2-25 years received risdiplam at the dose of 5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20 kg for 12 months.
10787389|NCT02908685|BG011|Baseline|Part 2: Placebo|Participants aged 2-25 years received placebo matching to risdiplam for 12 months. After 12 months of treatment with placebo, participants switched to risdiplam (5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20) in a blinded manner and participants will continue with treatment and observations.
10787390|NCT02908685|BG012|Baseline|Total|Total of all reporting groups
10787391|NCT02908685|FG000|Participant Flow|Part 1 Group A Cohort 1: Adolescents and Adults (3 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed and Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787392|NCT02908685|FG001|Participant Flow|Part 1 Group A Cohort 2: Adolescents and Adults (5 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed and Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787393|NCT02908685|FG002|Participant Flow|Part 1 Group A Cohort 1: Adolescents and Adults (Placebo)|Adolescent and adult participants aged 12-25 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to their cohort risdiplam dose (i.e. 3 mg). After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787394|NCT02908685|FG003|Participant Flow|Part 1 Group A Cohort 2: Adolescents and Adults (Placebo)|Adolescent and adult participants aged 12-25 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to their cohort risdiplam dose (i.e. 5 mg). After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787395|NCT02908685|FG004|Participant Flow|Part 1 Group B Cohort 1: Children (0.02 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. During the placebo-controlled period, participants escalated to 0.05 mg/kg and then to 0.15 mg/kg in two steps. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787396|NCT02908685|FG005|Participant Flow|Part 1 Group B Cohort 2: Children (0.05 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. During the placebo-controlled period, participants escalated to 0.15 mg/kg in one step. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787397|NCT02908685|FG006|Participant Flow|Part 1 Group B Cohort 3: Children (0.25 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787398|NCT02908685|FG007|Participant Flow|Part 1 Group B Cohort 1: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to the final 0.15 mg/kg cohort risdiplam dose. After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787399|NCT02908685|FG008|Participant Flow|Part 1 Group B Cohort 2: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, participants first switched to the final 0.15 mg/kg cohort risdiplam dose. After the Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
11382379|NCT01116648|OG002|Outcome|Level 2|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
10787400|NCT02908685|FG009|Participant Flow|Part 1 Group B Cohort 3: Children (Placebo)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks. Once the placebo-controlled period was completed, and after Part 2 dose was selected, participants switched to Part 2 dose and were treated in an open-label phase.
10787401|NCT02908685|FG010|Participant Flow|Part 2: Risdiplam|Participants aged 2-25 years received risdiplam at the dose of 5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20 kg for 12 months.
10787402|NCT02908685|FG011|Participant Flow|Part 2: Placebo|Participants aged 2-25 years received placebo matching to risdiplam for 12 months. After 12 months of treatment with placebo, participants switched to risdiplam (5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20) in a blinded manner and participants will continue with treatment and observations.
10787403|NCT02908685|OG000|Outcome|Part 1: All Risdiplam|Children aged 2-11 years and adolescent and adult participants aged 12-25 years received risdiplam or risdiplam matching placebo.
10787404|NCT02908685|OG000|Outcome|Part 2: Risdiplam|Participants aged 2-25 years received risdiplam at the dose of 5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20 kg for 12 months.
10787405|NCT02908685|OG001|Outcome|Part 2: Placebo|Participants aged 2-25 years received placebo matching to risdiplam for 12 months. After 12 months of treatment with placebo, participants switched to risdiplam (5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20) in a blinded manner and participants will continue with treatment and observations.
10787406|NCT02908685|EG000|Reported Event|Part 1 Group A: Adolescents and Adults (3 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787407|NCT02908685|EG001|Reported Event|Part 1 Group A: Adolescents and Adults (5 mg Risdiplam)|Adolescent and adult participants aged 12-25 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787408|NCT02908685|EG002|Reported Event|Part 1 Group A: Adolescents and Adults (Placebo-Control Period Pooled)|Adolescent and adult participants aged 12-25 years received placebo matching to risdiplam for at least 12 weeks during the placebo-controlled period.
10787409|NCT02908685|EG003|Reported Event|Part 1 Group B: Children (0.02 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787410|NCT02908685|EG004|Reported Event|Part 1 Group B: Children (0.05 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787411|NCT02908685|EG005|Reported Event|Part 1 Group B: Children (0.15 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787412|NCT02908685|EG006|Reported Event|Part 1 Group B: Children (0.25 mg/kg Risdiplam)|Children aged 2-11 years received risdiplam for at least 12 weeks during the placebo-controlled period.
10787413|NCT02908685|EG007|Reported Event|Part 1 Group B: Children (Placebo-Control Period Pooled)|Children aged 2-11 years received placebo matching to risdiplam for at least 12 weeks during the placebo-controlled period.
10787414|NCT02908685|EG008|Reported Event|Part 1 Group A: OLE|Once the placebo-controlled period was completed and Part 2 dose was selected, adolescents and adults switched to Part 2 dose and were treated in an open-label extension (OLE) phase.
10787415|NCT02908685|EG009|Reported Event|Part 1 Group B: OLE|Once the placebo-controlled period was completed and Part 2 dose was selected, children switched to Part 2 dose and were treated in an open-label extension (OLE) phase.
10787416|NCT02908685|EG010|Reported Event|Part 2: Risdiplam|Participants aged 2-25 years received risdiplam at the dose of 5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20 kg for 12 months.
10787417|NCT02908685|EG011|Reported Event|Part 2: Placebo|Participants aged 2-25 years received placebo matching to risdiplam for 12 months. After 12 months of treatment with placebo, participants switched to risdiplam (5 mg once daily for participants with a body weight (BW) >/=20kg or 0.25 mg/kg for participants with a BW <20) in a blinded manner and participants will continue with treatment and observations.
10787418|NCT02881957|BG000|Baseline|Vitamin D3|Patient demographics of patients receiving study drug
10787419|NCT02881957|BG001|Baseline|Placebo|Patient demographics of patients receiving placebo
10787420|NCT02881957|BG002|Baseline|Total|Total of all reporting groups
10787421|NCT02881957|FG000|Participant Flow|Placebo|"Placebo control (simple oral syrup)~Placebo: Oral syrup placebo"
10787422|NCT02881957|FG001|Participant Flow|Vitamin D3|"Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)~Cholecalciferol"
10787423|NCT02881957|OG000|Outcome|Vitamin D3|Patient demographics of patients receiving study drug
10787424|NCT02881957|OG001|Outcome|Placebo|Patient demographics of patients receiving placebo
10787425|NCT02881957|EG000|Reported Event|Vitamin D3|Patient demographics of patients receiving study drug
10787426|NCT02881957|EG001|Reported Event|Placebo|Patient demographics of patients receiving placebo
10787427|NCT02880189|BG000|Baseline|Single|"All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.~Orbera Intragastric Balloon: The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.~Endoscopic Ultrasound Guided Core Liver Biopsy"
10787428|NCT02880189|FG000|Participant Flow|Single|"All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.~Orbera Intragastric Balloon: The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.~Endoscopic Ultrasound Guided Core Liver Biopsy"
10787429|NCT02880189|OG000|Outcome|Single|"All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.~Orbera Intragastric Balloon: The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.~Endoscopic Ultrasound Guided Core Liver Biopsy"
10787430|NCT02880189|EG000|Reported Event|Single|"All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.~Orbera Intragastric Balloon: The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.~Endoscopic Ultrasound Guided Core Liver Biopsy"
10787431|NCT02761694|BG000|Baseline|Part 1: Vevorisertib 5 mg QD|Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
10787432|NCT02761694|BG001|Baseline|Part 1: Vevorisertib 10 mg QD|Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
10787433|NCT02761694|BG002|Baseline|Part 1: Vevorisertib 20 mg QD|Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
10787434|NCT02761694|BG003|Baseline|Part 1: Vevorisertib 25 mg QD|Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
10787435|NCT02761694|BG004|Baseline|Part 1: Vevorisertib 25 mg QOD|Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
10787436|NCT02761694|BG005|Baseline|Part 1: Vevorisertib 50 mg QD|Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
10787437|NCT02761694|BG006|Baseline|Part 1: Vevorisertib 75 mg QD|Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
10787438|NCT02761694|BG007|Baseline|Part 1: Vevorisertib 100 mg QD|Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
10787439|NCT02761694|BG008|Baseline|Part 2: Vevorisertib 50 mg QD Plus Paclitaxel|Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787440|NCT02761694|BG009|Baseline|Part 2: Vevorisertib 75 mg QD Plus Paclitaxel|Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787441|NCT02761694|BG010|Baseline|Part 2: Vevorisertib 50 mg QD Plus Fulvestrant|Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787442|NCT02761694|BG011|Baseline|Part 2: Vevorisertib 75 mg QD Plus Fulvestrant|Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787443|NCT02761694|BG012|Baseline|Total|Total of all reporting groups
10787444|NCT02761694|FG000|Participant Flow|Part 1: Vevorisertib 5 mg QD|Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
10787445|NCT02761694|FG001|Participant Flow|Part 1: Vevorisertib 10 mg QD|Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
10787446|NCT02761694|FG002|Participant Flow|Part 1: Vevorisertib 20 mg QD|Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
10787447|NCT02761694|FG003|Participant Flow|Part 1: Vevorisertib 25 mg QD|Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
10787448|NCT02761694|FG004|Participant Flow|Part 1: Vevorisertib 25 mg QOD|Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
10787449|NCT02761694|FG005|Participant Flow|Part 1: Vevorisertib 50 mg QD|Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
10787450|NCT02761694|FG006|Participant Flow|Part 1: Vevorisertib 75 mg QD|Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
10787451|NCT02761694|FG007|Participant Flow|Part 1: Vevorisertib 100 mg QD|Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
10787452|NCT02761694|FG008|Participant Flow|Part 2: Vevorisertib 50 mg QD Plus Paclitaxel|Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787453|NCT02761694|FG009|Participant Flow|Part 2: Vevorisertib 75 mg QD Plus Paclitaxel|Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787454|NCT02761694|FG010|Participant Flow|Part 2: Vevorisertib 50 mg QD Plus Fulvestrant|Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787455|NCT02761694|FG011|Participant Flow|Part 2: Vevorisertib 75 mg QD Plus Fulvestrant|Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787456|NCT02761694|OG000|Outcome|Part 1: Vevorisertib 5 mg QD|Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
10787457|NCT02761694|OG001|Outcome|Part 1: Vevorisertib 10 mg QD|Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
10787458|NCT02761694|OG002|Outcome|Part 1: Vevorisertib 20 mg|Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
10787459|NCT02761694|OG003|Outcome|Part 1: Vevorisertib 25 mg QD|Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
10966623|NCT00887822|EG000|Reported Event|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
10787460|NCT02761694|OG004|Outcome|Part 1: Vevorisertib 25 mg QOD|Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
10787461|NCT02761694|OG005|Outcome|Part 1: Vevorisertib 50 mg QD|Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
10787462|NCT02761694|OG006|Outcome|Part 1: Vevorisertib 75 mg QD|Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
10787463|NCT02761694|OG007|Outcome|Part 1: Vevorisertib 100 mg QD|Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
10787464|NCT02761694|OG008|Outcome|Part 2: Vevorisertib 50 mg QD Plus Paclitaxel|Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787465|NCT02761694|OG009|Outcome|Part 2: Vevorisertib 75 mg QD Plus Paclitaxel|Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787466|NCT02761694|OG010|Outcome|Part 2: Vevorisertib 50 mg QD Plus Fulvestrant|Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787467|NCT02761694|OG011|Outcome|Part 2: Vevorisertib 75 mg QD Plus Fulvestrant|Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787468|NCT02761694|OG002|Outcome|Part 1: Vevorisertib 20 mg QD|Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
10787469|NCT02761694|EG000|Reported Event|Part 1: Vevorisertib 5 mg QD|Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.
10787470|NCT02761694|EG001|Reported Event|Part 1: Vevorisertib 10 mg QD|Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.
10787471|NCT02761694|EG002|Reported Event|Part 1: Vevorisertib 20 mg QD|Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.
10787472|NCT02761694|EG003|Reported Event|Part 1: Vevorisertib 25 mg QD|Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.
10787473|NCT02761694|EG004|Reported Event|Part 1: Vevorisertib 25 mg QOD|Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.
10787474|NCT02761694|EG005|Reported Event|Part 1: Vevorisertib 50 mg QD|Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.
10787475|NCT02761694|EG006|Reported Event|Part 1: Vevorisertib 75 mg QD|Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.
10787476|NCT02761694|EG007|Reported Event|Part 1: Vevorisertib 100 mg QD|Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.
10787477|NCT02761694|EG008|Reported Event|Part 2: Vevorisertib 50 mg QD Plus Paclitaxel|Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787478|NCT02761694|EG009|Reported Event|Part 2: Vevorisertib 75 mg QD Plus Paclitaxel|Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.
10787479|NCT02761694|EG010|Reported Event|Part 2: Vevorisertib 50 mg QD Plus Fulvestrant|Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787480|NCT02761694|EG011|Reported Event|Part 2: Vevorisertib 75 mg QD Plus Fulvestrant|Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.
10787481|NCT02611960|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
10787482|NCT02611960|BG001|Baseline|Standard Treatment|Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
10787483|NCT02611960|BG002|Baseline|Total|Total of all reporting groups
10787484|NCT02611960|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
10787485|NCT02611960|FG001|Participant Flow|Standard Treatment|Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
10787486|NCT02611960|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
10787487|NCT02611960|OG001|Outcome|Standard Treatment|Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
10787488|NCT02611960|EG000|Reported Event|Pembrolizumab (First Course)|Participants received pembrolizumab 200 mg IV Q3W until PD or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years).
11382380|NCT01116648|OG003|Outcome|Level 3|Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
10787489|NCT02611960|EG001|Reported Event|Standard Treatment|Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
10787490|NCT02611960|EG002|Reported Event|Pembrolizumab (Second Course)|Eligible participants randomized to the pembrolizumab arm who stopped pembrolizumab with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
10787491|NCT02574455|BG000|Baseline|Sacituzumab Govitecan|Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
10787492|NCT02574455|BG001|Baseline|Treatment of Physician's Choice (TPC)|"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.~Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).~Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.~Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.~Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy."
10787493|NCT02574455|BG002|Baseline|Total|Total of all reporting groups
10787494|NCT02574455|FG000|Participant Flow|Sacituzumab Govitecan|Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
10787495|NCT02574455|FG001|Participant Flow|Treatment of Physician's Choice (TPC)|"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.~Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).~Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.~Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.~Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy."
10787496|NCT02574455|OG000|Outcome|Sacituzumab Govitecan|Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
10787497|NCT02574455|OG001|Outcome|Treatment of Physician's Choice (TPC)|"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.~Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).~Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.~Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.~Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy."
10787498|NCT02574455|EG000|Reported Event|Sacituzumab Govitecan|Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
11382381|NCT01116648|OG000|Outcome|All Phase 1 Participants (28 Participants)|All Phase 1 participants who received at least 1 dose of olaparib and cediranib.
10787499|NCT02574455|EG001|Reported Event|Treatment of Physician's Choice (TPC)|"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.~Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).~Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.~Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.~Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy."
10787500|NCT02493660|BG000|Baseline|InSpace Implantation|"Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation~InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system"
10787501|NCT02493660|BG001|Baseline|Tendon Repair|"Arthroscopic partial repair of rotator cuff~Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff"
10787502|NCT02493660|BG002|Baseline|Total|Total of all reporting groups
10787503|NCT02493660|FG000|Participant Flow|InSpace Implantation|"Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation~InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system"
10787504|NCT02493660|FG001|Participant Flow|Tendon Repair|"Arthroscopic partial repair of rotator cuff~Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff"
10787505|NCT02493660|OG000|Outcome|InSpace Implantation|InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
10787506|NCT02493660|OG001|Outcome|Tendon Repair|Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
10787507|NCT02493660|OG000|Outcome|InSpace Implantation|"Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation~InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system"
10787508|NCT02493660|OG001|Outcome|Tendon Repair|"Arthroscopic partial repair of rotator cuff~Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff"
10787509|NCT02493660|EG000|Reported Event|InSpace Implantation|"Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation~InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system"
10787510|NCT02493660|EG001|Reported Event|Tendon Repair|"Arthroscopic partial repair of rotator cuff~Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff"
10787511|NCT02232087|BG000|Baseline|All Subjects|salmeterol and fluticasone propionate
10787512|NCT02232087|FG000|Participant Flow|Sequence 1 (A, F, B, E, C, D)|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787513|NCT02232087|FG001|Participant Flow|Sequence 2 (B, A, C, F, D, E)|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787514|NCT02232087|FG002|Participant Flow|Sequence 3 (C, B, D, A, E, F)|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787515|NCT02232087|FG003|Participant Flow|Sequence 4 (D, C, E, B, F, A)|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787516|NCT02232087|FG004|Participant Flow|Sequence 5 (E, D, F, C, A, B)|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787517|NCT02232087|FG005|Participant Flow|Sequence 6 (F, E, A, D, B, C )|"salmeterol and fluticasone propionate per inhalation~A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)"
10787518|NCT02232087|OG000|Outcome|Test B and C vs Reference E and F|"salmeterol and fluticasone propionate~Salmeterol: B, E 6 puffs; C, F 12 puffs~fluticasone propionate: B, E 6 puffs; C, F 12 puffs"
10787519|NCT02232087|OG000|Outcome|Test A and B vs Reference D and E|"salmeterol and fluticasone propionate~Salmeterol: A, D 2 puffs; B, E 6 puffs~fluticasone propionate: A, D 2 puffs; B, E 6 puffs"
10787520|NCT02232087|OG000|Outcome|Test Product A|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 2 inhalations~fluticasone propionate: 2 inhalations"
10787521|NCT02232087|OG001|Outcome|Reference Product D|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 2 inhalations~fluticasone propionate: 2 inhalations"
10787522|NCT02232087|OG002|Outcome|Test Product B|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 6 inhalations~fluticasone propionate: 6 inhalations"
10787523|NCT02232087|OG003|Outcome|Reference Product E|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 6 inhalations~fluticasone propionate: 6 inhalations"
10787524|NCT02232087|OG004|Outcome|Test Product C|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 12 inhalations~fluticasone propionate: 12 inhalations"
10787525|NCT02232087|OG005|Outcome|Reference Product F|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate):12 inhalations~fluticasone propionate: 12 inhalations"
10787526|NCT02232087|OG000|Outcome|Test Product A|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 2, 6, and 12 inhalations~fluticasone propionate: 2 inhalations"
10787527|NCT02232087|OG005|Outcome|Reference Product F|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 12 inhalations~fluticasone propionate: 12 inhalations"
10787528|NCT02232087|OG004|Outcome|Test Product D|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 12 inhalations~fluticasone propionate: 12 inhalations"
10787529|NCT02232087|EG000|Reported Event|Test Product A|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 2 inhalations~fluticasone propionate: 2 inhalations"
10787530|NCT02232087|EG001|Reported Event|Test Product B|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 6 inhalations~fluticasone propionate: 6 inhalations"
10787531|NCT02232087|EG002|Reported Event|Test Product C|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 12 inhalations~fluticasone propionate: 12 inhalations"
10787532|NCT02232087|EG003|Reported Event|Reference Product D|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 6 inhalations~fluticasone propionate: 6 inhalations"
10787533|NCT02232087|EG004|Reported Event|Reference Product E|"salmeterol and fluticasone propionate~salmeterol (as salmeterol xinafoate): 12 inhalations~fluticasone propionate: 12 inhalations"
10787534|NCT02232087|EG005|Reported Event|Referencet Product F|salmeterol and fluticasone propionate
10787535|NCT02065154|BG000|Baseline|Treatment|"Cyclophosphamide (Cytoxan)~Cyclophosphamide"
10787536|NCT02065154|FG000|Participant Flow|Cyclophosphamide (Cytoxan)|"Cyclophosphamide (Cytoxan)~Cyclophosphamide"
11382382|NCT01116648|OG000|Outcome|Phase 2 - Olaparib Alone (46 Participants)|Assess the efficacy (as measured by progression-free survival (PFS) ) of olaparib alone in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
10787537|NCT02065154|OG000|Outcome|Treatment|"Cyclophosphamide (Cytoxan)~Cyclophosphamide"
10787538|NCT02065154|EG000|Reported Event|Cytoxan|Patients getting cytoxan
10787539|NCT01952847|BG000|Baseline|Radiation Therapy to Esophagus Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787540|NCT01952847|BG001|Baseline|Radiation Therapy to Esophagus Patient Group - Placebo|"Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787541|NCT01952847|BG002|Baseline|mTOR Inhibitor Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787542|NCT01952847|BG003|Baseline|mTOR Inhibitor Patient Group - Placebo|"Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787543|NCT01952847|BG004|Baseline|Total|Total of all reporting groups
10787544|NCT01952847|FG000|Participant Flow|Radiation Therapy to Esophagus Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787545|NCT01952847|FG001|Participant Flow|Radiation Therapy to Esophagus Patient Group - Placebo|"Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787546|NCT01952847|FG002|Participant Flow|mTOR Inhibitor Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787547|NCT01952847|FG003|Participant Flow|mTOR Inhibitor Patient Group - Placebo|"Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787548|NCT01952847|OG000|Outcome|Radiation Therapy to Esophagus Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787549|NCT01952847|OG001|Outcome|Radiation Therapy to Esophagus Patient Group - Placebo|"Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787550|NCT01952847|OG000|Outcome|mTOR Inhibitor Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787551|NCT01952847|OG001|Outcome|mTOR Inhibitor Patient Group - Placebo|"Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787552|NCT01952847|OG000|Outcome|Radiation Therapy to Esophagus Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787553|NCT01952847|OG001|Outcome|Radiation Therapy to Esophagus Patient Group - Placebo|"Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787554|NCT01952847|EG000|Reported Event|Radiation Therapy to Esophagus Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787555|NCT01952847|EG001|Reported Event|Radiation Therapy to Esophagus Patient Group - Placebo|"Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
10787556|NCT01952847|EG002|Reported Event|mTOR Inhibitor Patient Group - Glutamine|"Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787557|NCT01952847|EG003|Reported Event|mTOR Inhibitor Patient Group - Placebo|"Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.~Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit."
10787558|NCT01889238|BG000|Baseline|Enzalutamide|Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
10787559|NCT01889238|FG000|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression (DP), intolerable adverse events (AEs) (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
10787560|NCT01889238|OG000|Outcome|Enzalutamide|Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
10787561|NCT01889238|EG000|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
10787562|NCT01740427|BG000|Baseline|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787563|NCT01740427|BG001|Baseline|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787564|NCT01740427|BG002|Baseline|Total|Total of all reporting groups
10787565|NCT01740427|FG000|Participant Flow|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787566|NCT01740427|FG001|Participant Flow|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787567|NCT01740427|OG000|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787568|NCT01740427|OG001|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787569|NCT01740427|EG000|Reported Event|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787570|NCT01740427|EG001|Reported Event|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
10787571|NCT01672892|BG000|Baseline|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
10787572|NCT01672892|BG001|Baseline|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
10787573|NCT01672892|BG002|Baseline|Total|Total of all reporting groups
10787574|NCT01672892|FG000|Participant Flow|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
10787575|NCT01672892|FG001|Participant Flow|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
10787576|NCT01672892|OG000|Outcome|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
10787577|NCT01672892|OG001|Outcome|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
10787578|NCT01672892|OG000|Outcome|Intensity-Modulated Radiation Therapy (A)|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
10787579|NCT01672892|OG001|Outcome|Standard Radiation Therapy (B)|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
10787580|NCT01672892|OG000|Outcome|All Participants|Participants from both treatment arms combined.
10787581|NCT01672892|EG000|Reported Event|Intensity-Modulated Radiation Therapy|Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
10787582|NCT01672892|EG001|Reported Event|Standard Radiation Therapy|Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
10787583|NCT01560585|BG000|Baseline|Open Label|"All participants will receive Isotretinoin for 24 weeks~Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks"
10787584|NCT01560585|FG000|Participant Flow|Open Label|"All participants will receive Isotretinoin for 24 weeks~Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks"
10787585|NCT01560585|OG000|Outcome|Open Label Treatment|All participants will receive Isotretinoin for 24 weeks
10787586|NCT01560585|OG000|Outcome|Open Label|"All participants will receive Isotretinoin for 24 weeks~Isotretinoin: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks"
10787587|NCT01560585|EG000|Reported Event|Open Label Treatment|Study terminated due to adverse events leading to PI decision to terminate study
10787588|NCT00979212|BG000|Baseline|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787589|NCT00979212|BG001|Baseline|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787590|NCT00979212|BG002|Baseline|Total|Total of all reporting groups
10787591|NCT00979212|FG000|Participant Flow|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787592|NCT00979212|FG001|Participant Flow|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787593|NCT00979212|OG000|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787594|NCT00979212|OG001|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787595|NCT00979212|EG000|Reported Event|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787596|NCT00979212|EG001|Reported Event|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
10787597|NCT00777491|BG000|Baseline|5-FU and Cisplatin + BID Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787598|NCT00777491|BG001|Baseline|Gemcitabine + QD Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787599|NCT00777491|BG002|Baseline|Total|Total of all reporting groups
10787600|NCT00777491|FG000|Participant Flow|5-FU and Cisplatin + BID Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID [twice daily] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787601|NCT00777491|FG001|Participant Flow|Gemcitabine + QD Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD [once a day] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787602|NCT00777491|OG000|Outcome|5-FU and Cisplatin + BID Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787603|NCT00777491|OG001|Outcome|Gemcitabine + QD Irradiation|Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
10787604|NCT00777491|EG000|Reported Event|Arm I|Patients receive induction therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 8-10.
10787605|NCT00777491|EG001|Reported Event|Arm II|Patients receive induction therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 8-10.
10787606|NCT00759655|BG000|Baseline|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
10787607|NCT00759655|FG000|Participant Flow|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
10787608|NCT00759655|OG000|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
10787609|NCT00759655|EG000|Reported Event|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
10787610|NCT00145795|BG000|Baseline|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
10787611|NCT00145795|BG001|Baseline|Current Regimen|Patients in this study arm continued their current regimen.
10787612|NCT00145795|BG002|Baseline|Total|Total of all reporting groups
10787613|NCT00145795|FG000|Participant Flow|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
10787614|NCT00145795|FG001|Participant Flow|Current Regimen|Patients in this study arm continued their current regimen.
10787615|NCT00145795|OG000|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
10787616|NCT00145795|OG001|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
10787617|NCT00145795|EG000|Reported Event|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
10787618|NCT00145795|EG001|Reported Event|Current Regimen|Patients in this study arm continued their current regimen.
10787619|NCT00005044|BG000|Baseline|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787620|NCT00005044|BG001|Baseline|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787621|NCT00005044|BG002|Baseline|Total|Total of all reporting groups
10787622|NCT00005044|FG000|Participant Flow|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787623|NCT00005044|FG001|Participant Flow|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787624|NCT00005044|OG000|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787625|NCT00005044|OG001|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787626|NCT00005044|EG000|Reported Event|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787627|NCT00005044|EG001|Reported Event|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
10787628|NCT00002874|BG000|Baseline|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
10787629|NCT00002874|BG001|Baseline|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
10787630|NCT00002874|BG002|Baseline|Total|Total of all reporting groups
10787631|NCT00002874|FG000|Participant Flow|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
10787632|NCT00002874|FG001|Participant Flow|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
10787633|NCT00002874|OG000|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
10787634|NCT00002874|OG001|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
10787635|NCT00002874|EG000|Reported Event|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
10787636|NCT00002874|EG001|Reported Event|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
10802168|NCT02549209|FG000|Participant Flow|Investigational Treatment|"Subjects with no prior therapy:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 175mg/m2~Carboplatin administered at an AUC of 6~Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 135mg/m2~Carboplatin administered at an AUC of 5~Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects~Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.~Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.~Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.~Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes."
10802169|NCT02549209|OG000|Outcome|Investigational Treatment|"Subjects with no prior therapy:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 175mg/m2~Carboplatin administered at an AUC of 6~Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 135mg/m2~Carboplatin administered at an AUC of 5~Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects~Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.~Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.~Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.~Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes."
10802170|NCT02549209|EG000|Reported Event|Investigational Treatment|"Subjects with no prior therapy:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 175mg/m2~Carboplatin administered at an AUC of 6~Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:~Pembrolizumab administered at 200 mg~Paclitaxel administered at 135mg/m2~Carboplatin administered at an AUC of 5~Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects~Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.~Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.~Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.~Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes."
10802171|NCT02496676|BG000|Baseline|Magnesium, Then Placebo|In phase 1, participants received oral magnesium L-threonate for 12 weeks then crossover to placebo for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
10802172|NCT02496676|BG001|Baseline|Placebo, Then Magnesium|In phase 1, participants received oral placebo for 12 weeks then crossover to oral magnesium L-threonate for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
10802173|NCT02496676|BG002|Baseline|Total|Total of all reporting groups
10802174|NCT02496676|FG000|Participant Flow|Magnesium, Then Placebo|In phase 1, participants received oral magnesium L-threonate for 12 weeks then crossover to placebo for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
10802175|NCT02496676|FG001|Participant Flow|Placebo, Then Magnesium|In phase 1, participants received oral placebo for 12 weeks then crossover to oral magnesium L-threonate for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
10802176|NCT02496676|OG000|Outcome|Magnesium|Participants received oral magnesium L-threonate for 12 weeks
10802177|NCT02496676|OG001|Outcome|Placebo|Participants received oral placebo for 12 weeks
10802178|NCT02496676|OG000|Outcome|Magnesium|In phase 2, participants received 3 days of intravenous MgSO4 daily at 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
10802179|NCT02496676|OG000|Outcome|Phase 1 - Oral Magnesium|In phase 1, participants received oral magnesium L-threonate for 12 weeks
10802180|NCT02496676|OG001|Outcome|Phase 1 - Placebo|Participants received oral placebo for 12 weeks
10802181|NCT02496676|OG002|Outcome|Phase 2 - IV MgSO4|In phase 2, participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day
10802182|NCT02496676|OG003|Outcome|Phase 2 - Oral Magnesium|In phase 2, participants received oral magnesium L-threonate for 24 weeks.
10787637|NCT04391894|BG000|Baseline|ECF843 0.45 mg/mL TID (Part 1)|ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)
10787638|NCT04391894|BG001|Baseline|ECF843 0.15 mg/mL TID (Part 1)|ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)
10787639|NCT04391894|BG002|Baseline|ECF843 Vehicle TID (Part 1)|ECF843 vehicle ter in die/three times a day (TID) (Part 1)
10787640|NCT04391894|BG003|Baseline|ECF843 0.15 mg/mL BID (Part 1)|ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)
10787641|NCT04391894|BG004|Baseline|ECF843 Vehicle BID (Part 1)|ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
10787642|NCT04391894|BG005|Baseline|Total|Total of all reporting groups
10787643|NCT04391894|FG000|Participant Flow|ECF843 0.45 mg/mL TID (Part 1)|ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)
10787644|NCT04391894|FG001|Participant Flow|ECF843 0.15 mg/mL TID (Part 1)|ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)
10787645|NCT04391894|FG002|Participant Flow|ECF843 Vehicle TID (Part 1)|ECF843 vehicle ter in die/three times a day (TID) (Part 1)
10787646|NCT04391894|FG003|Participant Flow|ECF843 0.15 mg/mL BID (Part 1)|ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)
10787647|NCT04391894|FG004|Participant Flow|ECF843 Vehicle BID (Part 1)|ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
10787648|NCT04391894|OG000|Outcome|ECF843 0.45 mg/mL TID (Part 1)|ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)
10787649|NCT04391894|OG001|Outcome|ECF843 0.15 mg/mL TID (Part 1)|ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)
10787650|NCT04391894|OG002|Outcome|ECF843 Vehicle TID (Part 1)|ECF843 vehicle ter in die/three times a day (TID) (Part 1)
10787651|NCT04391894|OG003|Outcome|ECF843 0.15 mg/mL BID (Part 1)|ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)
10787652|NCT04391894|OG004|Outcome|ECF843 Vehicle BID (Part 1)|ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
10787653|NCT04391894|EG000|Reported Event|ECF843 0.45 mg/mL TID (Part 1)|ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)
10787654|NCT04391894|EG001|Reported Event|ECF843 0.15 mg/mL TID (Part 1)|ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)
10787655|NCT04391894|EG002|Reported Event|ECF843 Vehicle TID (Part 1)|ECF843 vehicle ter in die/three times a day (TID) (Part 1)
10787656|NCT04391894|EG003|Reported Event|ECF843 0.15 mg/mL BID (Part 1)|ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)
10787657|NCT04391894|EG004|Reported Event|ECF843 Vehicle BID (Part 1)|ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
10787658|NCT04151628|BG000|Baseline|Roll-in|The first subject enrolled at each site is considered a roll-in. Data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
10787659|NCT04151628|BG001|Baseline|Intent to Treat (ITT)|The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is ongoing.
10787660|NCT04151628|BG002|Baseline|Total|Total of all reporting groups
10787661|NCT04151628|FG000|Participant Flow|Roll-in|The first subject enrolled at each site is considered a roll-in. Data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
10787662|NCT04151628|FG001|Participant Flow|Intent to Treat (ITT)|The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is ongoing.
10787663|NCT04151628|OG000|Outcome|Intent To Treat|The Intent To Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is ongoing.
10787664|NCT04151628|OG000|Outcome|Intent to Treat (ITT)|The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is ongoing.
10787665|NCT04151628|EG000|Reported Event|Coronary IVL System(Roll-In) Through 30Days|Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30days, at which time subject participation was complete.
10787666|NCT04151628|EG001|Reported Event|Coronary IVL System(ITT) Through 30Days|Adverse events reported through 30 days post-procedure for ITT subjects. The ITT analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints.
10787667|NCT04151628|EG002|Reported Event|Coronary IVL System(ITT) Through 12Months|Adverse events reported through 12 months post-procedure for ITT subjects. Adverse event data on ITT subjects was collected through12 months for long-term follow-up. Long-term follow-up for ITT subjects to 24 months is ongoing.
10787668|NCT04097925|BG000|Baseline|Doravirine + Descovy® TAF/FTC|"Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks~Doravirine: Doravirine 100 mg tablet~Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet"
10787669|NCT04097925|FG000|Participant Flow|Doravirine + Descovy® TAF/FTC|"Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks~Doravirine: Doravirine 100 mg tablet~Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet"
10787670|NCT04097925|OG000|Outcome|Doravirine + Descovy® TAF/FTC|"Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks~Doravirine: Doravirine 100 mg tablet~Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet"
10787671|NCT04097925|EG000|Reported Event|Doravirine + Descovy® TAF/FTC|"Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks~Doravirine: Doravirine 100 mg tablet~Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet"
10787672|NCT03614663|BG000|Baseline|ZYN002 - Cannabidiol Transdermal Gel|"ZYN002 supplied as a transdermal gel. Patients weighing less than or equal to 35 kg will be randomized to receive either 125 mg cannabidiol Q12H or placebo.~Patients weighing greater than 35 kg will be randomized to receive 250 mg cannabidiol Q12H or placebo.~ZYN002 - cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)"
10787673|NCT03614663|BG001|Baseline|Placebo Transdermal Gel|"Matching ZYN002 placebo supplied as a transdermal gel.~Placebo Transdermal Gel: Placebo formulated as a clear gel (transdermal delivery)"
10787674|NCT03614663|BG002|Baseline|Total|Total of all reporting groups
10787675|NCT03614663|FG000|Participant Flow|ZYN002 - Cannabidiol Transdermal Gel|"ZYN002 supplied as a transdermal gel. Patients weighing less than or equal to 35 kg will be randomized to receive either 125 mg cannabidiol Q12H or placebo.~Patients weighing greater than 35 kg will be randomized to receive 250 mg cannabidiol Q12H or placebo.~ZYN002 - Cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)"
10787676|NCT03614663|FG001|Participant Flow|Placebo Transdermal Gel|"Matching ZYN002 placebo supplied as a transdermal gel.~Placebo Transdermal Gel: Placebo formulated as a clear gel (transdermal delivery)"
10787677|NCT03614663|OG000|Outcome|ZYN002 - Cannabidiol Transdermal Gel|ZYN002 - Cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)
10787678|NCT03614663|OG001|Outcome|Placebo|Placebo formulated as a clear gel (transdermal delivery)
10787679|NCT03614663|OG000|Outcome|ZYN002 - Cannabidiol Transdermal Gel|ZYN002 - cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)
10787680|NCT03614663|OG001|Outcome|Placebo Transdermal Gel|Placebo Transdermal Gel: Placebo formulated as a clear gel (transdermal delivery)
10787681|NCT03614663|EG000|Reported Event|ZYN002 - Cannabidiol Transdermal Gel|ZYN002 - Cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)
10787682|NCT03614663|EG001|Reported Event|Placebo Transdermal Gel|Placebo Transdermal Gel: Placebo formulated as a clear gel (transdermal delivery)
10787683|NCT03501966|BG000|Baseline|Acetazolamide Including Diet|"Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~Acetazolamide: Medical therapy including diet"
10787684|NCT03501966|BG001|Baseline|Optic Nerve Sheath Fenestration|"Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.~Optic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration"
10787685|NCT03501966|BG002|Baseline|Ventriculoperitoneal CSF Shunting|"Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.~Ventriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting"
10787686|NCT03501966|BG003|Baseline|Total|Total of all reporting groups
10787687|NCT03501966|FG000|Participant Flow|Acetazolamide Including Diet|"Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~Acetazolamide: Medical therapy including diet"
10787688|NCT03501966|FG001|Participant Flow|Optic Nerve Sheath Fenestration|"Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.~Optic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration"
10787689|NCT03501966|FG002|Participant Flow|Ventriculoperitoneal CSF Shunting|"Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.~Ventriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting"
10787690|NCT03501966|OG000|Outcome|Acetazolamide Including Diet|"Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~Acetazolamide: Medical therapy including diet"
10802183|NCT02496676|OG003|Outcome|Phase 2 - Oral Magnesium|In phase 2, participants received oral magnesium L-threonate for 24 weeks
10802184|NCT02496676|EG000|Reported Event|Phase 1 - Oral Magnesium|In phase 1, participants received oral magnesium L-threonate for 12 weeks
10802185|NCT02496676|EG001|Reported Event|Phase 1 - Placebo|Participants received oral placebo for 12 weeks
10787691|NCT03501966|OG001|Outcome|Optic Nerve Sheath Fenestration|"Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.~Optic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration"
10787692|NCT03501966|OG002|Outcome|Ventriculoperitoneal CSF Shunting|"Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.~Ventriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting"
10787693|NCT03501966|EG000|Reported Event|Acetazolamide Including Diet|"Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~Acetazolamide: Medical therapy including diet"
10787694|NCT03501966|EG001|Reported Event|Optic Nerve Sheath Fenestration|"Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.~Optic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration"
10787695|NCT03501966|EG002|Reported Event|Ventriculoperitoneal CSF Shunting|"Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol).~Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.~VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.~Ventriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting"
10787696|NCT03489291|BG000|Baseline|AMT-061|AAV5-hFIXco-Padua (AMT-061): Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
10787697|NCT03489291|FG000|Participant Flow|AMT-061|AAV5-hFIXco-Padua (AMT-061): Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
10787698|NCT03489291|OG000|Outcome|AMT-061|AAV5-hFIXco-Padua (AMT-061): Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
10787699|NCT03489291|EG000|Reported Event|AMT-061|AAV5-hFIXco-Padua (AMT-061): Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
10787700|NCT03428100|BG000|Baseline|Placebo|Placebo administered orally once daily in combination with topical corticosteroids.
10787701|NCT03428100|BG001|Baseline|1 mg Baricitinib|"1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
10787702|NCT03428100|BG002|Baseline|2 mg Baricitinib|2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787703|NCT03428100|BG003|Baseline|4 mg Baricitinib|4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787704|NCT03428100|BG004|Baseline|Total|Total of all reporting groups
10787705|NCT03428100|FG000|Participant Flow|Placebo|Placebo administered orally once daily in combination with topical corticosteroids.
10787706|NCT03428100|FG001|Participant Flow|1 mg Baricitinib|"1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
10787707|NCT03428100|FG002|Participant Flow|2 mg Baricitinib|2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787708|NCT03428100|FG003|Participant Flow|4 mg Baricitinib|4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787709|NCT03428100|OG000|Outcome|Placebo|Placebo administered orally once daily in combination with topical corticosteroids.
10787710|NCT03428100|OG001|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787711|NCT03428100|OG002|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787712|NCT03428100|OG001|Outcome|1 mg Baricitinib|"1 mg Baricitinib administered orally once daily in combination with topical corticosteroids.~Placebo administered orally to maintain the blind"
10787713|NCT03428100|OG001|Outcome|1 mg Baricitinib|"1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
10787714|NCT03428100|OG002|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787715|NCT03428100|OG003|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787716|NCT03428100|OG001|Outcome|1 mg Baricitinib|1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
11382383|NCT01116648|OG001|Outcome|Phase 2 - Cediranib/Olaparib (44 Participants)|Assess the efficacy (as measured by progression-free survival (PFS) ) of the combination of cediranib and olaparib in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
11382384|NCT01116648|OG000|Outcome|All Phase 1-T Participants|All Phase 1-T participants who received protocol treatment.
11382385|NCT01116648|EG000|Reported Event|Phase I Dose Level 0|"Participants received cediranib 20 mg daily and olaparib 100 mg twice daily.~Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules."
11382386|NCT01116648|EG001|Reported Event|Phase I Dose Level 1|"Participants received cediranib 20 mg daily and olaparib 200 mg twice daily.~Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules."
11382387|NCT01116648|EG002|Reported Event|Phase I Dose Level 2|"Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.~Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules."
11382388|NCT01116648|EG003|Reported Event|Phase I Dose Level 3|"Participants received cediranib 30 mg daily and olaparib 400 mg twice daily.~Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules."
11382389|NCT01116648|EG004|Reported Event|Phase I Expansion Cohort at MTD|"Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.~Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules."
11382390|NCT01116648|EG005|Reported Event|Phase II Olaparib Alone|Participants received olaparib capsule monotherapy 400 mg orally twice daily.
11382391|NCT01116648|EG006|Reported Event|Phase II Cediranib/Olaparib|Participants received a previously established recommended Phase 2 dose of cediranib 30 mg orally daily with olaparib capsules 200 mg orally twice daily.
11382392|NCT01116648|EG007|Reported Event|Phase I-T Dose Level 0-TA|Participants received 30 mg cediranib daily with olaparib tablets at 150 mg twice daily.
11382393|NCT01116648|EG008|Reported Event|Phase I-T Dose Level 1-TA|Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
11382394|NCT01116648|EG009|Reported Event|Phase I-T Dose Level 1-TPKCed|Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
11382395|NCT01116648|EG010|Reported Event|Phase I-T Dose Level 1-TPKOlap|Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
11382396|NCT01116648|EG011|Reported Event|Phase I-T Dose Level 2-TA|Participants received 30 mg cediranib daily with olaparib tablets at 250 mg twice daily.
11382397|NCT01116648|EG012|Reported Event|Phase I-T Dose Level 0-TB|Participants received 20 mg cediranib daily with olaparib tablets at 200 mg twice daily.
11382398|NCT01116648|EG013|Reported Event|Phase I-T Dose Level 1-TB|Participants received 20 mg cediranib daily with olaparib tablets at 250 mg twice daily.
11382399|NCT01116648|EG014|Reported Event|Phase I-T Dose Level 2-TB|Participants received 20 mg cediranib daily with olaparib tablets at 300 mg twice daily.
11382400|NCT01065454|BG000|Baseline|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
10787717|NCT03428100|OG000|Outcome|Placebo|Placebo administered orally every day in combination with topical corticosteroids.
11382401|NCT01065454|BG001|Baseline|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
11382402|NCT01065454|BG002|Baseline|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
11382403|NCT01065454|BG003|Baseline|Placebo|Participants received placebo tid.
11382404|NCT01065454|BG004|Baseline|Total|Total of all reporting groups
11382405|NCT01065454|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
11382406|NCT01065454|FG001|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
11382407|NCT01065454|FG002|Participant Flow|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
11382408|NCT01065454|FG003|Participant Flow|Placebo|Participants received placebo tid.
11382409|NCT01065454|OG000|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
11382410|NCT01065454|OG001|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
11382411|NCT01065454|OG002|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
11382412|NCT01065454|OG003|Outcome|Placebo|Participants received placebo tid.
11382413|NCT01065454|EG000|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
11382414|NCT01065454|EG001|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg)
11382415|NCT01065454|EG002|Reported Event|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose)
11382416|NCT01065454|EG003|Reported Event|Placebo|Participants received placebo tid
11382417|NCT01064648|BG000|Baseline|Phase I All Participants|All participants from Phase I
11382418|NCT01064648|BG001|Baseline|Phase II Cisplatin-pemetrexed Cediranib 20mg|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382419|NCT01064648|BG002|Baseline|Phase II Cisplatin-pemetrexed Placebo|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity.~Placebo: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382420|NCT01064648|BG003|Baseline|Total|Total of all reporting groups
11382421|NCT01064648|FG000|Participant Flow|Phase I Cisplatin-pemetrexed Cediranib 30mg|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382422|NCT01064648|FG001|Participant Flow|Phase I Cisplatin-pemetrexed Cediranib 20mg|"Patients receive pemetrexed disodium and cisplatin as in arm I and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV~Placebo: Given orally"
11382423|NCT01064648|FG002|Participant Flow|Phase II Cisplatin-pemetrexed Cediranib 20mg|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382424|NCT01064648|FG003|Participant Flow|Phase II Cisplatin-pemetrexed Placebo|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity.~Placebo: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382425|NCT01064648|OG000|Outcome|All Phase I Participants|All participants from Phase I who are eligible for DLT. Patients will be considered evaluable for DLT if they received at least 14 doses of cediranib at the assigned dose during Cycle 1 and at least one dose each of pemetrexed and cisplatin, or if they developed a DLT. If a patient does not develop a DLT but does not complete at least 14 doses of cediranib and one dose each of pemetrexed and cisplatin during Cycle 1 due to any reason, the patient will be considered not evaluable for DLT and will be replaced.
11382426|NCT01064648|OG000|Outcome|Phase II Cisplatin-pemetrexed Cediranib 20mg|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382427|NCT01064648|OG001|Outcome|Phase II Cisplatin-pemetrexed Placebo|"Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity.~Placebo: Given orally~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pemetrexed Disodium: Given IV"
11382428|NCT01064648|OG000|Outcome|Phase I Cisplatin-pemetrexed Cediranib 30mg|Phase I Cisplatin-pemetrexed Cediranib 30mg
11382429|NCT01064648|OG001|Outcome|Phase I Cisplatin-pemetrexed Cediranib 20mg|Phase I Cisplatin-pemetrexed Cediranib 20mg
11382430|NCT01064648|OG000|Outcome|Phase II Cisplatin-pemetrexed Cediranib 20mg|Phase II Cisplatin-pemetrexed Cediranib 20mg
11382431|NCT01064648|OG001|Outcome|Phase II Cisplatin-pemetrexed Placebo|Phase II Cisplatin-pemetrexed Placebo
11382432|NCT01064648|EG000|Reported Event|Phase I Cisplatin-pemetrexed Cediranib 30mg|Phase I Cisplatin-pemetrexed Cediranib 30mg
11382433|NCT01064648|EG001|Reported Event|Phase I Cisplatin-pemetrexed Cediranib 20mg|Phase I Cisplatin-pemetrexed Cediranib 20mg
11382434|NCT01064648|EG002|Reported Event|Phase II Cisplatin-pemetrexed Cediranib 20mg|Phase II Cisplatin-pemetrexed Cediranib 20mg
11382435|NCT01064648|EG003|Reported Event|Phase II Cisplatin-pemetrexed Placebo|Phase II Cisplatin-pemetrexed Placebo
11382436|NCT01063517|BG000|Baseline|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
11382437|NCT01063517|BG001|Baseline|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
11382438|NCT01063517|BG002|Baseline|Total|Total of all reporting groups
11382439|NCT01063517|FG000|Participant Flow|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
11382440|NCT01063517|FG001|Participant Flow|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
10787718|NCT03428100|OG001|Outcome|1 mg Baricitinib|"1 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
11382441|NCT01063517|OG000|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
10787719|NCT03428100|OG002|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787720|NCT03428100|OG003|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787721|NCT03428100|OG001|Outcome|1 mg Baricitinib|1 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787722|NCT03428100|OG001|Outcome|1 mg Baricitinib|"1 mg Baricitinib administered once daily day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
10787723|NCT03428100|EG000|Reported Event|Placebo|Placebo administered orally once daily in combination with topical corticosteroids.
10787724|NCT03428100|EG001|Reported Event|1 mg Baricitinib|"1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.~."
10787725|NCT03428100|EG002|Reported Event|2 mg Baricitinib|2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787726|NCT03428100|EG003|Reported Event|4 mg Baricitinib|4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
10787727|NCT03341936|BG000|Baseline|Nivolumab+Lirilumab|"The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection.~In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle~In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.~Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells~Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells"
10787728|NCT03341936|FG000|Participant Flow|Nivolumab+Lirilumab|"The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection.~In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle~In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.~Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells~Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells"
10787729|NCT03341936|OG000|Outcome|Nivolumab+Lirilumab|"The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection.~In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle~In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.~Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells~Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells"
10787730|NCT03341936|EG000|Reported Event|Nivolumab+Lirilumab|"The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection.~In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle~In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.~Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells~Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells"
10787731|NCT03174353|BG000|Baseline|Lanreotide Arm|"Single arm study. A single deep subcutaneous dose of lanreotide (Somatuline Depot 120 Mg/0.5Ml) will be administered prior to planned resection on the day of surgery.~Lanreotide Prefilled Syringe: All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-operative area at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock."
10787732|NCT03174353|FG000|Participant Flow|Lanreotide Arm|"Single arm study. A single deep subcutaneous dose of lanreotide (Somatuline Depot 120 Mg/0.5Ml) will be administered prior to planned resection on the day of surgery.~Lanreotide Prefilled Syringe: All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-operative area at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock."
10787733|NCT03174353|OG000|Outcome|Lanreotide Arm|Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
10787734|NCT03174353|EG000|Reported Event|Lanreotide Arm|Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
10787735|NCT03144687|BG000|Baseline|Cohort A|Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787736|NCT03144687|BG001|Baseline|Cohort B|Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787737|NCT03144687|BG002|Baseline|Total|Total of all reporting groups
10802186|NCT02496676|EG002|Reported Event|Phase 2 - IV MgSO4|In phase 2, participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day
10802187|NCT02496676|EG003|Reported Event|Phase 2 - Oral Magnesium|In phase 2, participants received oral magnesium L-threonate for 24 weeks
10802188|NCT02494141|BG000|Baseline|Curcumin|"25/mg/kg per day for 1 year.~Curcumin: Dietary Supplement"
10787738|NCT03144687|FG000|Participant Flow|Cohort A|Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787739|NCT03144687|FG001|Participant Flow|Cohort B|Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787740|NCT03144687|OG000|Outcome|Cohort A|Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787741|NCT03144687|OG001|Outcome|Cohort B|Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787742|NCT03144687|OG000|Outcome|PK: Cohort A (Itacitinib)|Participants received itacitinib at the dose of 200 mg, orally, QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
10787743|NCT03144687|OG001|Outcome|PK: Cohort B (Itacitinib)|Participants itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
10787744|NCT03144687|OG000|Outcome|PK: Cohort A (Ruxolitinib)|Participants received ruxolitinib, orally, BID at their previous stable dose (must have been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
10787745|NCT03144687|EG000|Reported Event|Cohort A|Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787746|NCT03144687|EG001|Reported Event|Cohort B|Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment were met.
10787747|NCT03144687|EG002|Reported Event|Total|Total
10787748|NCT03090737|BG000|Baseline|Arm A|480 mg of Nivolumab every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
10787749|NCT03090737|FG000|Participant Flow|Arm A|480 mg of Nivolumab every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
10787750|NCT03090737|OG000|Outcome|Arm A|480 mg of Nivolumab every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
10787751|NCT03090737|EG000|Reported Event|Arm A|480 mg of Nivolumab every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
10787752|NCT02947646|BG000|Baseline|BabyGentleStick™ ON, Then BabyGentleStick™ OFF|Experimental intervention followed by Active Comparator.
10787753|NCT02947646|BG001|Baseline|BabyGentleStick™ OFF, Then BabyGentleStick™ ON|Active Comparator followed by Experimental intervention.
10787754|NCT02947646|BG002|Baseline|Total|Total of all reporting groups
10787755|NCT02947646|FG000|Participant Flow|BabyGentleStick™ ON, Then BabyGentleStick™ OFF|Experimental intervention first (5 minutes), followed by Active Comparator (5 minutes).
10787756|NCT02947646|FG001|Participant Flow|BabyGentleStick™ OFF, Then BabyGentleStick™ ON|Active Comparator first (5 minutes), then Experimental intervention (5 minutes).
10787757|NCT02947646|OG000|Outcome|BabyGentleStick™ ON|Experimental intervention, whether it was performed first or was performed after Active Comparator
10787758|NCT02947646|OG001|Outcome|BabyGentleStick™ OFF|Active Comparator, whether it was performed first or was performed after Experimental intervention
10787759|NCT02947646|OG000|Outcome|BabyGentleStick™ ON|Experimental intervention, whether it was performed first or was performed after the Active Comparator.
10787760|NCT02947646|OG001|Outcome|BabyGentleStick™ OFF|Active Comparator, whether it was performed first or was performed after the Experimental intervention.
10787761|NCT02947646|EG000|Reported Event|BabyGentleStick™ ON|"Experimental intervention to be compared to the Active Comparator.~BabyGentleStick™ ON"
10787762|NCT02947646|EG001|Reported Event|BabyGentleStick™ OFF|"Active Comparator intervention to be compared to the Experimental interventional.~BabyGentleStick™ OFF"
10787763|NCT02880371|BG000|Baseline|Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10802189|NCT02494141|BG001|Baseline|Placebo|"Equivalent placebo for 1 year.~Placebo"
10802190|NCT02494141|BG002|Baseline|Total|Total of all reporting groups
10787764|NCT02880371|BG001|Baseline|Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787765|NCT02880371|BG002|Baseline|Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787766|NCT02880371|BG003|Baseline|Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787767|NCT02880371|BG004|Baseline|Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787768|NCT02880371|BG005|Baseline|Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort|Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787769|NCT02880371|BG006|Baseline|Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort|Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787770|NCT02880371|BG007|Baseline|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787771|NCT02880371|BG008|Baseline|Total|Total of all reporting groups
10787772|NCT02880371|FG000|Participant Flow|Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 milligrams (mg) orally, once daily (QD) in combination with pembrolizumab at a dose of 2 milligram per kilogram (mg/kg) intravenously (IV) every 3 weeks (Q3W) in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787773|NCT02880371|FG001|Participant Flow|Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787774|NCT02880371|FG002|Participant Flow|Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787775|NCT02880371|FG003|Participant Flow|Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787776|NCT02880371|FG004|Participant Flow|Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787777|NCT02880371|FG005|Participant Flow|Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort|Participants who progressed on a programmed cell death receptor 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) inhibitor-containing regimen as their most recent prior line of therapy and were new to prior colony-stimulating factor 1 receptor (CSF-1R) or colony-stimulating factor 1(CSF-1) inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787778|NCT02880371|FG006|Participant Flow|Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort|Participants with PDA who had at least 1 prior line of therapy and were new to prior checkpoint inhibitor (CPI) therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787779|NCT02880371|FG007|Participant Flow|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787780|NCT02880371|OG000|Outcome|Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787781|NCT02880371|OG001|Outcome|Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787782|NCT02880371|OG002|Outcome|Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787783|NCT02880371|OG000|Outcome|Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort|Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787784|NCT02880371|OG001|Outcome|Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort|Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787785|NCT02880371|OG002|Outcome|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787786|NCT02880371|OG003|Outcome|Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort|Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787787|NCT02880371|OG004|Outcome|Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort|Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787788|NCT02880371|OG005|Outcome|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787789|NCT02880371|OG000|Outcome|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10802191|NCT02494141|FG000|Participant Flow|Curcumin|"25/mg/kg per day for 1 year.~Curcumin: Dietary Supplement"
10802192|NCT02494141|FG001|Participant Flow|Placebo|"Equivalent placebo for 1 year.~Placebo"
11194746|NCT02153918|FG000|Participant Flow|Vaccine Plus Booster Shots|"PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC~PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules."
11382442|NCT01063517|OG001|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
11382443|NCT01063517|EG000|Reported Event|OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD|
11382444|NCT01063517|EG001|Reported Event|PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD|
10787790|NCT02880371|EG000|Reported Event|Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787791|NCT02880371|EG001|Reported Event|Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787792|NCT02880371|EG002|Reported Event|Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787793|NCT02880371|EG003|Reported Event|Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787794|NCT02880371|EG004|Reported Event|Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab|Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787795|NCT02880371|EG005|Reported Event|Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort|Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787796|NCT02880371|EG006|Reported Event|Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort|Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787797|NCT02880371|EG007|Reported Event|Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort|Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
10787798|NCT02562235|BG000|Baseline|Riociguat >=6 to <18 Years|Participants with age ≥6 to <18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.
10787799|NCT02562235|FG000|Participant Flow|Riociguat >=6 to <18 Years|Participants with age ≥6 to <18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.
10787800|NCT02562235|OG000|Outcome|Riociguat >=6 to <18 Years|Participants with age ≥6 to <18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.
10787801|NCT02562235|OG000|Outcome|Riociguat 1.0 mg or Equivalent - PK|Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement
10787802|NCT02562235|OG000|Outcome|Riociguat 0.5 mg or Equivalent - PK|Participants who received riociguat at 0.5 mg or body weight-adjusted dose equivalent to the exposure of 0.5 mg dose in adults at the day of PK measurement
10787803|NCT02562235|OG001|Outcome|Riociguat 1.0 mg or Equivalent - PK|Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement
11241067|NCT02484690|FG003|Participant Flow|Arm D: Faricimab, 6 mg Every 4-8 Weeks|Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
10787804|NCT02562235|OG002|Outcome|Riociguat 2.0 mg or Equivalent - PK|Participants who received riociguat at 2.0 mg or body weight-adjusted dose equivalent to the exposure of 2.0 mg dose in adults at the day of PK measurement
10787805|NCT02562235|OG003|Outcome|Riociguat 2.5 mg or Equivalent - PK|Participants who received riociguat at 2.5 mg or body weight-adjusted dose equivalent to the exposure of 2.5 mg dose in adults at the day of PK measurement
10802193|NCT02494141|OG000|Outcome|Curcumin|"25/mg/kg per day for 1 year.~Curcumin: Dietary Supplement"
10802194|NCT02494141|OG001|Outcome|Placebo|"Equivalent placebo for 1 year.~Placebo"
10787806|NCT02562235|EG000|Reported Event|Riociguat >=6 to <18 Years|Participants with age ≥6 to <18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.
10787807|NCT02477696|BG000|Baseline|Acalabrutinib - Arm A|Participants in this arm receive the Investigational Product (IP), ACP196, also known as Acalabrutinib. Patients take 100mg two times daily indefinitely, or until disease progression.
10787808|NCT02477696|BG001|Baseline|Ibrutinib - Arm B|Participants in this arm receive the comparator drug and current standard of treatment, Ibrutinib, also known as brand name 'Imbruvica'. Patients take 420mg once daily indefinitely, or until disease progression.
10787809|NCT02477696|BG002|Baseline|Total|Total of all reporting groups
10787810|NCT02477696|FG000|Participant Flow|Acalabrutinib - Arm A|Participants in this arm receive the Investigational Product (IP), ACP196, also known as Acalabrutinib. Patients take 100mg two times daily indefinitely, or until disease progression.
10787811|NCT02477696|FG001|Participant Flow|Ibrutinib - Arm B|Participants in this arm receive the comparator drug and current standard of treatment, Ibrutinib, also known as brand name 'Imbruvica'. Patients take 420mg once daily indefinitely, or until disease progression.
10787812|NCT02477696|OG000|Outcome|Acalabrutinib|Participants in this arm receive the Investigational Product (IP), ACP196, also known as Acalabrutinib. Patients take 100mg two times daily indefinitely, or until disease progression.
10787813|NCT02477696|OG001|Outcome|Ibrutinib|Participants in this arm receive the comparator drug and current standard of treatment, Ibrutinib, also known as brand name 'Imbruvica'. Patients take 420mg once daily indefinitely, or until disease progression.
10787814|NCT02477696|EG000|Reported Event|Acalabrutinib - Arm A|Participants in this arm receive the Investigational Product (IP), ACP196, also known as Acalabrutinib. Patients take 100mg two times daily indefinitely, or until disease progression.
10787815|NCT02477696|EG001|Reported Event|Ibrutinib - Arm B|Participants in this arm receive the comparator drug and current standard of treatment, Ibrutinib, also known as brand name 'Imbruvica'. Patients take 420mg once daily indefinitely, or until disease progression.
10787816|NCT02434354|BG000|Baseline|Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV|Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
10787817|NCT02434354|FG000|Participant Flow|Neo-adjuvant/Adjuvant Pembrolizumab 200mgIV|Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
10787818|NCT02434354|OG000|Outcome|Neo-adjuvant/Adjuvant Pembrolizaumab 200 mg IV|"All subjects will receive 1 cycle neo-adjuvant pembrolizumab 200mg IV followed by complete surgical resection followed by pembrolizumab Q3weeks for 1 year~pembrolizumab: 200 mg Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete resection and then a year of adjuvant pembrolizumab"
10787819|NCT02434354|EG000|Reported Event|Neo-adjuvant/Adjuvant Pembrolizumab 200mg IV|Pembrolizumab 200 mg: Subjects received 1 dose of neoadjuvant pembrolizumab, followed by complete resection, and then a year of adjuvant pembrolizumab.
10787820|NCT02419417|BG000|Baseline|Part 1 Schedule A - BMS-986158 0.75 mg|Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787821|NCT02419417|BG001|Baseline|Part 1 Schedule A - BMS-986158 1.25 mg|Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787822|NCT02419417|BG002|Baseline|Part 1 Schedule A - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787823|NCT02419417|BG003|Baseline|Part 1 Schedule A - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787824|NCT02419417|BG004|Baseline|Part 1 Schedule A - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787825|NCT02419417|BG005|Baseline|Part 1 Schedule B - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787826|NCT02419417|BG006|Baseline|Part 1 Schedule B - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787827|NCT02419417|BG007|Baseline|Part 1 Schedule C - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787828|NCT02419417|BG008|Baseline|Part 1 Schedule C - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787829|NCT02419417|BG009|Baseline|Part 1 Schedule C - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787830|NCT02419417|BG010|Baseline|Part 2 Schedule A|"BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.~Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle"
10787831|NCT02419417|BG011|Baseline|Total|Total of all reporting groups
10787832|NCT02419417|FG000|Participant Flow|Part 1 Schedule A - BMS-986158 0.75 mg|Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787833|NCT02419417|FG001|Participant Flow|Part 1 Schedule A - BMS-986158 1.25 mg|Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787834|NCT02419417|FG002|Participant Flow|Part 1 Schedule A - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787835|NCT02419417|FG003|Participant Flow|Part 1 Schedule A - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787836|NCT02419417|FG004|Participant Flow|Part 1 Schedule A - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787837|NCT02419417|FG005|Participant Flow|Part 1 Schedule B - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787838|NCT02419417|FG006|Participant Flow|Part 1 Schedule B - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787839|NCT02419417|FG007|Participant Flow|Part 1 Schedule C - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787840|NCT02419417|FG008|Participant Flow|Part 1 Schedule C - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787841|NCT02419417|FG009|Participant Flow|Part 1 Schedule C - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787842|NCT02419417|FG010|Participant Flow|Part 2 Schedule A|"BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.~Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle"
10787843|NCT02419417|OG000|Outcome|Part 1 Schedule A - BMS-986158 0.75 mg|Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787844|NCT02419417|OG001|Outcome|Part 1 Schedule A - BMS-986158 1.25 mg|Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787845|NCT02419417|OG002|Outcome|Part 1 Schedule A - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787846|NCT02419417|OG003|Outcome|Part 1 Schedule A - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787847|NCT02419417|OG004|Outcome|Part 1 Schedule A - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787848|NCT02419417|OG005|Outcome|Part 1 Schedule B - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787849|NCT02419417|OG006|Outcome|Part 1 Schedule B - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787850|NCT02419417|OG007|Outcome|Part 1 Schedule C - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787851|NCT02419417|OG008|Outcome|Part 1 Schedule C - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787852|NCT02419417|OG009|Outcome|Part 1 Schedule C - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787853|NCT02419417|OG010|Outcome|Part 2 Schedule A|"BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.~Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle"
10787854|NCT02419417|OG000|Outcome|BMS-986158 0.75 mg|All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
10787855|NCT02419417|OG001|Outcome|BMS-986158 1.25 mg|All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
10787856|NCT02419417|OG002|Outcome|BMS-986158 2 mg|All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
10787857|NCT02419417|OG003|Outcome|BMS-986158 3 mg|All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
10787858|NCT02419417|OG004|Outcome|BMS-986158 4.5 mg|All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
10787859|NCT02419417|EG000|Reported Event|Part 1 Schedule A - BMS-986158 0.75 mg|Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787860|NCT02419417|EG001|Reported Event|Part 1 Schedule A - BMS-986158 1.25 mg|Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787861|NCT02419417|EG002|Reported Event|Part 1 Schedule A - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787862|NCT02419417|EG003|Reported Event|Part 1 Schedule A - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787863|NCT02419417|EG004|Reported Event|Part 1 Schedule A - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10787864|NCT02419417|EG005|Reported Event|Part 1 Schedule B - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787865|NCT02419417|EG006|Reported Event|Part 1 Schedule B - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
10787866|NCT02419417|EG007|Reported Event|Part 1 Schedule C - BMS-986158 2 mg|Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787867|NCT02419417|EG008|Reported Event|Part 1 Schedule C - BMS-986158 3 mg|Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787868|NCT02419417|EG009|Reported Event|Part 1 Schedule C - BMS-986158 4.5 mg|Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10787869|NCT02419417|EG010|Reported Event|Part 2 Schedule A|"BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.~Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle"
10787870|NCT02395120|BG000|Baseline|Intervention Letter|"The CSM-based referral letter alone will be sent to caregivers~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control)."
10787871|NCT02395120|BG001|Baseline|Intervention Letter+DIG|"The CSM-based referral letter with the dental information guide will be sent to caregivers.~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).~DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources."
10787872|NCT02395120|BG002|Baseline|Reduced Intervention Letter|"The reduced (removing text corresponding to timeline) CSM-based referral letter alone will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control)."
10787873|NCT02395120|BG003|Baseline|Reduced Intervention Letter+Reduced DIG|"The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).~Reduced DIG: Text and illustrations related to the timeline construct of the CSM have been removed in the reduced dental information guide."
11194747|NCT02153918|OG000|Outcome|Vaccine Plus Booster Shots|"PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC~PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules."
10787874|NCT02395120|BG004|Baseline|Standard Letter|"Modified standard letter will be sent to caregivers.~Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country."
10787875|NCT02395120|BG005|Baseline|Total|Total of all reporting groups
10787876|NCT02395120|FG000|Participant Flow|Intervention Letter|"The CSM-based referral letter alone will be sent to caregivers~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control)."
10787877|NCT02395120|FG001|Participant Flow|Intervention Letter+DIG|"The CSM-based referral letter with the dental information guide will be sent to caregivers.~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).~DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources."
10787878|NCT02395120|FG002|Participant Flow|Reduced Intervention Letter|"The reduced (removing text corresponding to timeline) CSM-based referral letter alone will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control)."
10787879|NCT02395120|FG003|Participant Flow|Reduced Intervention Letter+Reduced DIG|"The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).~Reduced DIG: Text and illustrations related to the timeline construct of the CSM have been removed in the reduced dental information guide."
10787880|NCT02395120|FG004|Participant Flow|Standard Letter|"Modified standard letter will be sent to caregivers.~Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country."
10787881|NCT02395120|OG000|Outcome|Intervention Letter|"The CSM-based referral letter alone will be sent to caregivers~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control)."
10787882|NCT02395120|OG001|Outcome|Intervention Letter+DIG|"The CSM-based referral letter with the dental information guide will be sent to caregivers.~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).~DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources."
10787883|NCT02395120|OG002|Outcome|Reduced Intervention Letter|"The reduced (removing text corresponding to timeline) CSM-based referral letter alone will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control)."
10787884|NCT02395120|OG003|Outcome|Reduced Intervention Letter+Reduced DIG|"The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).~Reduced DIG: Text and illustrations related to the timeline construct of the CSM have been removed in the reduced dental information guide."
10787885|NCT02395120|OG004|Outcome|Standard Letter|"Modified standard letter will be sent to caregivers.~Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country."
10787886|NCT02395120|EG000|Reported Event|Intervention Letter|"The CSM-based referral letter alone will be sent to caregivers~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control)."
10787887|NCT02395120|EG001|Reported Event|Intervention Letter+DIG|"The CSM-based referral letter with the dental information guide will be sent to caregivers.~Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).~DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources."
10787888|NCT02395120|EG002|Reported Event|Reduced Intervention Letter|"The reduced (removing text corresponding to timeline) CSM-based referral letter alone will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control)."
10787889|NCT02395120|EG003|Reported Event|Reduced Intervention Letter+Reduced DIG|"The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.~Reduced intervention letter: Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).~Reduced DIG: Text and illustrations related to the timeline construct of the CSM have been removed in the reduced dental information guide."
10787890|NCT02395120|EG004|Reported Event|Standard Letter|"Modified standard letter will be sent to caregivers.~Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country."
10787891|NCT02342275|BG000|Baseline|Propranolol|"Propranolol~Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24."
10787892|NCT02342275|BG001|Baseline|Atenolol|"Atenolol~Atenolol: Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24."
10787893|NCT02342275|BG002|Baseline|Total|Total of all reporting groups
10787894|NCT02342275|FG000|Participant Flow|Propranolol|"Propranolol~Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24."
10787895|NCT02342275|FG001|Participant Flow|Atenolol|"Atenolol~Atenolol: Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24."
10787896|NCT02342275|OG000|Outcome|Propranolol|"Propranolol~Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24."
10787897|NCT02342275|OG001|Outcome|Atenolol|"Atenolol~Atenolol: Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24."
10787898|NCT02342275|OG000|Outcome|Propranolol|Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.
10787899|NCT02342275|EG000|Reported Event|Propranolol|"Propranolol~Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24."
10787900|NCT02342275|EG001|Reported Event|Atenolol|"Atenolol~Atenolol: Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24."
10787901|NCT02075840|BG000|Baseline|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787902|NCT02075840|BG001|Baseline|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787903|NCT02075840|BG002|Baseline|Total|Total of all reporting groups
10787904|NCT02075840|FG000|Participant Flow|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787905|NCT02075840|FG001|Participant Flow|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787906|NCT02075840|OG000|Outcome|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787907|NCT02075840|OG001|Outcome|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787908|NCT02075840|EG000|Reported Event|Alectinib|Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
11194748|NCT02153918|EG000|Reported Event|Vaccine Plus Booster Shots|"PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC~PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules."
11194749|NCT02153983|BG000|Baseline|Obese Adults With Metabolic Syndrome Randomized to Placebo|Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily
10787909|NCT02075840|EG001|Reported Event|Crizotinib|Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
10787910|NCT02051608|BG000|Baseline|Part 1: Placebo|Participants received matching placebo by SC injection every 4 weeks Q4W up to 100 weeks during Part 1 of study.
11194750|NCT02153983|BG001|Baseline|Obese Adults With Metabolic Syndrome Randomized to Colchicine|Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily
11194751|NCT02153983|BG002|Baseline|Open Label Patients With Type 2 Diabetes|Adults with diet-controlled type 2 diabetes, treated with open-label Colchicine 0.6Mg Tab
11194752|NCT02153983|BG003|Baseline|Evaluation Only Non-obese Adults|Adults without obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.
11194753|NCT02153983|BG004|Baseline|Evaluation Only Obese Adults|Adults with obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.
11194754|NCT02153983|BG005|Baseline|Evaluation Only Adults With Diet-controlled Type 2 Diabetes|Adults with Diet-controlled Type 2 Diabetes, seen only for an evaluation visit, not given any medication and not followed longitudinally.
11194755|NCT02153983|BG006|Baseline|Total|Total of all reporting groups
11194756|NCT02153983|FG000|Participant Flow|Obese Adults With Metabolic Syndrome Randomized to Placebo|Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily
11194757|NCT02153983|FG001|Participant Flow|Obese Adults With Metabolic Syndrome Randomized to Colchicine|Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily
11194758|NCT02153983|FG002|Participant Flow|Open Label Patients With Type 2 Diabetes|Patients with diet-controlled type 2 dabetes, given open-label colchicine tablets 0.6 mg twice-daily
10787911|NCT02051608|BG001|Baseline|Part 1: Gantenerumab|Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
10787912|NCT02051608|BG002|Baseline|Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg|Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787913|NCT02051608|BG003|Baseline|Part 2 (OLE Treatment): Gantenerumab up to 1200 mg|Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787914|NCT02051608|BG004|Baseline|Total|Total of all reporting groups
11194759|NCT02153983|FG003|Participant Flow|Evaluation Only Non-obese Adults|Adults without obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.
11194760|NCT02153983|FG004|Participant Flow|Evaluation Only Obese Adults|Adults with obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.
10802195|NCT02494141|EG000|Reported Event|Curcumin|"25/mg/kg per day for 1 year.~Curcumin: Dietary Supplement"
11194761|NCT02153983|FG005|Participant Flow|Evaluation Only Adults With Type 2 Diabetes|Adults with Diet-controlled Type 2 Diabetes, seen only for an evaluation visit, not given any medication and not followed longitudinally.
11194762|NCT02153983|OG000|Outcome|Obese Adults With Metabolic Syndrome Randomized to Placebo|Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation, given twice daily
11194763|NCT02153983|OG001|Outcome|Obese Adults With Metabolic Syndrome Randomized to Colchicine|Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily
11194764|NCT02153983|OG002|Outcome|Open Label Patients With Type 2 Diabetes|Patients With Type 2 Diabetes given open-label treatment with colchicine 0.6 Mg Tab
11194765|NCT02153983|OG000|Outcome|Obese Adults With Metabolic Syndrome Randomized to Placebo|Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily
11194766|NCT02153983|OG002|Outcome|Open Label Patients With Type 2 Diabetes|Patients With Type 2 Diabetes given open-label colchicine tablets twice daily.
11194767|NCT02153983|OG002|Outcome|Open Label Patients With Type 2 Diabetes|Patients with type 2 diabetes given open-label colchicine tablets
11194768|NCT02153983|EG000|Reported Event|Obese Adults With Metabolic Syndrome Randomized to Placebo|Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily
11194769|NCT02153983|EG001|Reported Event|Obese Adults With Metabolic Syndrome Randomized to Colchicine|Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily
11194770|NCT02153983|EG002|Reported Event|Open Label Patients With Type 2 Diabetes|"Open-label treatment with colchicine~Colchicine 0.6Mg Tab: Open-label colchicine"
11194771|NCT02153983|EG003|Reported Event|Evaluation Only Non-obese Adults|No treatment non-obese adults seen only for evaluation
10787915|NCT02051608|FG000|Participant Flow|Part 1: Placebo|Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of study.
10787916|NCT02051608|FG001|Participant Flow|Part 1: Gantenerumab|Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
10787917|NCT02051608|FG002|Participant Flow|Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg|Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787918|NCT02051608|FG003|Participant Flow|Part 2 (OLE Treatment): Gantenerumab up to 1200 mg|Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787919|NCT02051608|OG000|Outcome|Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg|Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787920|NCT02051608|OG001|Outcome|Part 2 (OLE Treatment): Gantenerumab up to 1200 mg|Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787921|NCT02051608|OG000|Outcome|Part 1: Placebo|Participants received matching placebo by SC injection every 4 weeks Q4W up to 100 weeks during Part 1 of study.
10787922|NCT02051608|OG001|Outcome|Part 1: Gantenerumab|Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
10787923|NCT02051608|OG000|Outcome|Gantenerumab|Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
10787924|NCT02051608|OG001|Outcome|Part 2 (OLE Treatment): Gantenerumab up to 1200 mg|Participants who had received Gantenerumab by SC injection in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787925|NCT02051608|OG000|Outcome|Part 2 (OLE Treatment): Gantenerumab 1200 mg|Participants who had received placebo or gantenerumab in Part 1, received gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787926|NCT02051608|EG000|Reported Event|Part 1: Placebo|Participants received matching placebo by SC injection every 4 weeks Q4W up to 100 weeks during Part 1 of study.
10787927|NCT02051608|EG001|Reported Event|Part 1: Gantenerumab|Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
10787928|NCT02051608|EG002|Reported Event|Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mg|Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787929|NCT02051608|EG003|Reported Event|Part 2 (OLE Treatment): Gantenerumab up to 1200 mg|Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
10787930|NCT02015832|BG000|Baseline|Percutaneous Coronary Intervention|All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
10787931|NCT02015832|FG000|Participant Flow|Percutaneous Coronary Intervention|All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
10787932|NCT02015832|OG000|Outcome|SYNTAX II PCI Strategy Arm|Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.
10787933|NCT02015832|OG001|Outcome|Pre-defined SYNTAX I PCI Cohort|The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
10787934|NCT02015832|OG000|Outcome|SYNTAX II PCI Cohort|Patient with de-novo three vessel disease undergoing PCI according to the SYNTAX II strategy, including coronary physiology, imaging, and new generation drug-eluting stents.
10787935|NCT02015832|OG001|Outcome|SYNTAX I PCI Cohort|Patient with de-novo three vessel disease undergoing PCI according in the SYNTAX I trial, who would qualify as comparators for SYNTAX II based on equipoise between CABG and PCI using the SYNTAX score II calculator (www.syntaxscore.org).
10787936|NCT02015832|OG000|Outcome|SYNTAX II PCI Cohort|Patients with de-novo three vessel disease undergoing PCI according to the SYNTAX II strategy, including coronary physiology, imaging, and new generation drug-eluting stents.
10787937|NCT02015832|OG001|Outcome|SYNTAX I PCI Cohort|Patients with de-novo three vessel disease undergoing PCI according in the SYNTAX I trial, who would qualify as comparators for SYNTAX II based on equipoise between CABG and PCI using the SYNTAX score II calculator (www.syntaxscore.org).
10787938|NCT02015832|EG000|Reported Event|Percutaneous Coronary Intervention|All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
10787939|NCT01850524|BG000|Baseline|Placebo + LenDex|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787940|NCT01850524|BG001|Baseline|Ixazomib + LenDex|Participants received Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787941|NCT01850524|BG002|Baseline|Total|Total of all reporting groups
10787942|NCT01850524|FG000|Participant Flow|Placebo + LenDex|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787943|NCT01850524|FG001|Participant Flow|Ixazomib + LenDex|Participants received Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787944|NCT01850524|OG000|Outcome|Placebo + LenDex|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787945|NCT01850524|OG001|Outcome|Ixazomib + LenDex|Participants received Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787946|NCT01850524|EG000|Reported Event|Placebo + LenDex (Exposure Up to 18 Cycles)|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
10787947|NCT01850524|EG001|Reported Event|Ixazomib+ LenDex (Exposure Up to 18 Cycles)|Participants received ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
10787948|NCT01850524|EG002|Reported Event|Placebo + LenDex (Exposure ≥19 Cycles)|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787949|NCT01850524|EG003|Reported Event|Ixazomib + LenDex (Exposure ≥19 Cycles)|Participants received ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to data cut-off date 2 December 2019.
10787950|NCT01700673|BG000|Baseline|Myeloablative BMT|"Azacitidine and sargramostim after myeloablative stem cell transplant~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10787951|NCT01700673|BG001|Baseline|Non-myeloablative BMT|"Azacitidine and sargramostim after non-myeloablative stem cell transplant~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10787952|NCT01700673|BG002|Baseline|Standard Consolidation|"Azacitidine and sargramostim after standard consolidation~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10787953|NCT01700673|BG003|Baseline|Total|Total of all reporting groups
10787954|NCT01700673|FG000|Participant Flow|Myeloablative BMT|"Azacitidine and sargramostim after myeloablative stem cell transplant~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10802196|NCT02494141|EG001|Reported Event|Placebo|"Equivalent placebo for 1 year.~Placebo"
11194772|NCT02153983|EG004|Reported Event|Evaluation Only Obese Adults|No treatment obese adults seen only for evaluation
11194773|NCT02153983|EG005|Reported Event|Evaluation Only Adults With Diet-controlled Type 2 Diabetes|No treatment adults with Type 2 Diabetes seen only for evaluation
10787955|NCT01700673|FG001|Participant Flow|Non-myeloablative BMT|"Azacitidine and sargramostim after non-myeloablative stem cell transplant~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10787956|NCT01700673|FG002|Participant Flow|Standard Consolidation|"Azacitidine and sargramostim after standard consolidation~Azacitidine: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.~Sargramostim: Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles."
10787957|NCT01700673|OG000|Outcome|Non-myeloablative BMT|Azacitidine and sargramostim after non-myeloablative stem cell transplant
10787958|NCT01700673|OG001|Outcome|Myeloablative BMT|Azacitidine and sargramostim after myeloablative stem cell transplant
10787959|NCT01700673|OG002|Outcome|Standard Consolidation|Azacitidine and sargramostim after standard consolidation
10787960|NCT01700673|OG000|Outcome|Non-myeloablative|Azacitidine and sargramostim after non-myeloablative stem cell transplant
10787961|NCT01700673|EG000|Reported Event|Non-myeloablative BMT|Azacitidine and sargramostim after non-myeloablative stem cell transplant
10787962|NCT01700673|EG001|Reported Event|Myeloablative BMT|Azacitidine and sargramostim after myeloablative stem cell transplant
10787963|NCT01700673|EG002|Reported Event|Standard Consolidation|Azacitidine and sargramostim after standard consolidation
10787964|NCT01531374|BG000|Baseline|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787965|NCT01531374|BG001|Baseline|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787966|NCT01531374|BG002|Baseline|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787967|NCT01531374|BG003|Baseline|Total|Total of all reporting groups
10787968|NCT01531374|FG000|Participant Flow|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787969|NCT01531374|FG001|Participant Flow|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787970|NCT01531374|FG002|Participant Flow|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787971|NCT01531374|OG000|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787972|NCT01531374|OG001|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787973|NCT01531374|OG002|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787974|NCT01531374|OG000|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787975|NCT01531374|OG001|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787976|NCT01531374|EG000|Reported Event|Extreme Risk: TAVI Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787977|NCT01531374|EG001|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787978|NCT01531374|EG002|Reported Event|High Risk: TAVI|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
10787979|NCT01240902|BG000|Baseline|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
10787980|NCT01240902|BG001|Baseline|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
10787981|NCT01240902|BG002|Baseline|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
10787982|NCT01240902|BG003|Baseline|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
10787983|NCT01240902|BG004|Baseline|Total|Total of all reporting groups
10787984|NCT01240902|FG000|Participant Flow|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
10787985|NCT01240902|FG001|Participant Flow|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
10787986|NCT01240902|FG002|Participant Flow|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
10787987|NCT01240902|FG003|Participant Flow|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
10787988|NCT01240902|OG000|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
10787989|NCT01240902|OG001|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
10787990|NCT01240902|OG002|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
10787991|NCT01240902|OG003|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
10787992|NCT01240902|EG000|Reported Event|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
10787993|NCT01240902|EG001|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
10787994|NCT01240902|EG002|Reported Event|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
10787995|NCT01240902|EG003|Reported Event|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
10787996|NCT00726596|BG000|Baseline|Cohort A. Hydroxychloroquine (200mg Bid)|"Hydroxychloroquine - 400 mg (cohort A)~Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A)."
10787997|NCT00726596|BG001|Baseline|Cohort B. Hydroxychloroquine (200mg Tid)|"Hydroxychloroquine - 600 mg (cohort B)~Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B)."
10787998|NCT00726596|BG002|Baseline|Total|Total of all reporting groups
10787999|NCT00726596|FG000|Participant Flow|Cohort A. Hydroxychloroquine (200mg Bid)|"Hydroxychloroquine - 400 mg (cohort A)~Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A)."
10788000|NCT00726596|FG001|Participant Flow|Cohort B. Hydroxychloroquine (200mg Tid)|"Hydroxychloroquine - 600 mg (cohort B)~Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B)."
10788001|NCT00726596|OG000|Outcome|Cohort A. Hydroxychloroquine (200mg Bid)|"Hydroxychloroquine - 400 mg (cohort A)~Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A)."
10788002|NCT00726596|OG001|Outcome|Cohort B. Hydroxychloroquine (200mg Tid)|"Hydroxychloroquine - 600 mg (cohort B)~Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B)."
10788003|NCT00726596|EG000|Reported Event|Cohort A. Hydroxychloroquine (200mg Bid)|"Hydroxychloroquine - 400 mg (cohort A)~Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A)."
10788004|NCT00726596|EG001|Reported Event|Cohort B. Hydroxychloroquine (200mg Tid)|"Hydroxychloroquine - 600 mg (cohort B)~Once cohort A is completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B)."
10788005|NCT00489827|BG000|Baseline|Intravenous Glutamate|"Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788006|NCT00489827|BG001|Baseline|Saline Infusion|"Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788007|NCT00489827|BG002|Baseline|Total|Total of all reporting groups
10788008|NCT00489827|FG000|Participant Flow|Intravenous Glutamate|"Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788009|NCT00489827|FG001|Participant Flow|Saline Infusion|"Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788010|NCT00489827|OG000|Outcome|Intravenous Glutamate|"Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788011|NCT00489827|OG001|Outcome|Saline Infusion|"Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
11241068|NCT02484690|FG004|Participant Flow|Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W|Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
10788012|NCT00489827|EG000|Reported Event|Intravenous Glutamate|"Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788013|NCT00489827|EG001|Reported Event|Saline Infusion|"Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.~Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease."
10788014|NCT00278915|BG000|Baseline|Fulvestrant|Fulvestrant (4 mg / kg)
10788015|NCT00278915|FG000|Participant Flow|Fulvestrant|Fulvestrant (4 mg / kg)
10788016|NCT00278915|OG000|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
10788017|NCT00278915|EG000|Reported Event|Fulvestrant|Fulvestrant (4 mg / kg)
10802197|NCT02412618|BG000|Baseline|Mifepristone|"Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once~Mifepristone: Progesterone antagonist~Misoprostol: Prostaglandin E1"
10802198|NCT02412618|BG001|Baseline|Placebo|"Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once~Misoprostol: Prostaglandin E1~Placebo: Tasteless, odorless, sugar based pill"
10802199|NCT02412618|BG002|Baseline|Total|Total of all reporting groups
10802200|NCT02412618|FG000|Participant Flow|Mifepristone|"Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once~Mifepristone: Progesterone antagonist~Misoprostol: Prostaglandin E1"
10802201|NCT02412618|FG001|Participant Flow|Placebo|"Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once~Placebo: Tasteless, odorless, sugar based pill~Misoprostol: Prostaglandin E1"
11194774|NCT02154048|BG000|Baseline|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
11194775|NCT02154048|BG001|Baseline|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
10802202|NCT02412618|OG000|Outcome|Mifepristone|"Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once~Mifepristone: Progesterone antagonist~Misoprostol: Prostaglandin E1"
10802203|NCT02412618|OG001|Outcome|Placebo|"Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once~Placebo: Tasteless, odorless, sugar based pill~Misoprostol: Prostaglandin E1"
10802204|NCT02412618|EG000|Reported Event|Placebo|"Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once~Placebo: Tasteless, odorless, sugar based pill~Misoprostol: Prostaglandin E1"
10802205|NCT02412618|EG001|Reported Event|Mifepristone|"Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once~Mifepristone: Progesterone antagonist~Misoprostol: Prostaglandin E1"
10802206|NCT02373683|BG000|Baseline|Vapotherm-Heliox|"Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.~Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system."
10802207|NCT02373683|BG001|Baseline|Standard Care|Care dictated by clinical team.
10802208|NCT02373683|BG002|Baseline|Total|Total of all reporting groups
10802209|NCT02373683|FG000|Participant Flow|Vapotherm-Heliox|"Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.~Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system."
10802210|NCT02373683|FG001|Participant Flow|Standard Care|Care dictated by clinical team.
10802211|NCT02373683|OG000|Outcome|Vapotherm-Heliox|"Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.~Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system."
10802212|NCT02373683|OG001|Outcome|Standard Care|Care dictated by clinical team.
10802213|NCT02373683|EG000|Reported Event|Vapotherm-Heliox|"Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.~Vapotherm-Heliox: Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system."
10802214|NCT02373683|EG001|Reported Event|Standard Care|Care dictated by clinical team.
10802215|NCT02351180|BG000|Baseline|Inhaled Beclomethasone|"Inhaled beclomethasone 320 mcg twice daily for 180 days.~Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection"
10802216|NCT02351180|BG001|Baseline|Placebo|"Inhaled placebo twice daily for 180 days.~Placebo: Placebo will serve as a control treatment"
10802217|NCT02351180|BG002|Baseline|Total|Total of all reporting groups
10802218|NCT02351180|FG000|Participant Flow|Inhaled Beclomethasone|"Inhaled beclomethasone 320 mcg twice daily for 180 days.~Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection"
10802219|NCT02351180|FG001|Participant Flow|Placebo|"Inhaled placebo twice daily for 180 days.~Placebo: Placebo will serve as a control treatment"
10802220|NCT02351180|OG000|Outcome|Inhaled Beclomethasone|"Inhaled beclomethasone 320 mcg twice daily for 180 days.~Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection"
10802221|NCT02351180|OG001|Outcome|Placebo|"Inhaled placebo twice daily for 180 days.~Placebo: Placebo will serve as a control treatment"
10788018|NCT04505722|BG000|Baseline|Ad26.COV2.S|Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788019|NCT04505722|BG001|Baseline|Placebo|Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788020|NCT04505722|BG002|Baseline|Total|Total of all reporting groups
10788021|NCT04505722|FG000|Participant Flow|Ad26.COV2.S|Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788022|NCT04505722|FG001|Participant Flow|Placebo|Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788023|NCT04505722|OG000|Outcome|Ad26.COV2.S|Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788024|NCT04505722|OG001|Outcome|Placebo|Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788025|NCT04505722|EG000|Reported Event|Ad26.COV2.S|Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10788026|NCT04505722|EG001|Reported Event|Placebo|Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
10964759|NCT00879034|BG000|Baseline|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
10964760|NCT00879034|FG000|Participant Flow|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
10964761|NCT00879034|OG000|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
10964762|NCT00879034|EG000|Reported Event|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
10964763|NCT00879060|BG000|Baseline|Spironolactone|spironolactone: spironolactone 50mg daily
10964764|NCT00879060|BG001|Baseline|Placebo|spironolactone: spironolactone 50mg daily
10964765|NCT00879060|BG002|Baseline|Total|Total of all reporting groups
10964766|NCT00879060|FG000|Participant Flow|Spironolactone|Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued.
10964767|NCT00879060|FG001|Participant Flow|Placebo Control|Placebo group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of placebo.
11194776|NCT02154048|BG002|Baseline|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
11194777|NCT02154048|BG003|Baseline|Total|Total of all reporting groups
11194778|NCT02154048|FG000|Participant Flow|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
11194779|NCT02154048|FG001|Participant Flow|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
11194780|NCT02154048|FG002|Participant Flow|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
11194781|NCT02154048|OG000|Outcome|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
11194782|NCT02154048|OG001|Outcome|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
11194783|NCT02154048|OG002|Outcome|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
11194784|NCT02154048|EG000|Reported Event|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
11194785|NCT02154048|EG001|Reported Event|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
11194786|NCT02154048|EG002|Reported Event|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
11194787|NCT02154061|BG000|Baseline|IIV Flu Vaccine With Antibiotics|"This arm will receive antibiotics prior and after IIV administration.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.~Metronidazole: This is a standard antibiotic~Neomycin: This is a standard antibiotic.~Vancomycin: This is a standard antibiotic."
11194788|NCT02154061|BG001|Baseline|IIV Flu Vaccine|"This arm will not take antibiotics in conjunction with IIV.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine."
11194789|NCT02154061|BG002|Baseline|Total|Total of all reporting groups
11194790|NCT02154061|FG000|Participant Flow|IIV Flu Vaccine With Antibiotics|"This arm will receive antibiotics prior and after IIV administration.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.~Metronidazole: This is a standard antibiotic~Neomycin: This is a standard antibiotic.~Vancomycin: This is a standard antibiotic."
11194791|NCT02154061|FG001|Participant Flow|IIV Flu Vaccine|"This arm will not take antibiotics in conjunction with IIV.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine."
11194792|NCT02154061|OG000|Outcome|IIV Flu Vaccine With Antibiotics|"This arm will receive antibiotics prior and after IIV administration.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.~Metronidazole: This is a standard antibiotic~Neomycin: This is a standard antibiotic.~Vancomycin: This is a standard antibiotic."
11194793|NCT02154061|OG001|Outcome|IIV Flu Vaccine|"This arm will not take antibiotics in conjunction with IIV.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine."
11194794|NCT02154061|EG000|Reported Event|IIV Flu Vaccine With Antibiotics|"This arm will receive antibiotics prior and after IIV administration.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.~Metronidazole: This is a standard antibiotic~Neomycin: This is a standard antibiotic.~Vancomycin: This is a standard antibiotic."
11194795|NCT02154061|EG001|Reported Event|IIV Flu Vaccine|"This arm will not take antibiotics in conjunction with IIV.~Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine."
10964768|NCT00879060|OG000|Outcome|Spironolactone|"Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily.~Spironolactone: spironolactone 50mg daily"
10964769|NCT00879060|OG001|Outcome|Placebo Control|"Placebo group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to placebo group will be initiated on 25mg of placebo.~Placebo: placebo 25mg daily"
10964770|NCT00879060|OG001|Outcome|Placebo Control|"Placebo group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to placebo group will be initiated on an inactive placebo pill.~Placebo: inactive placebo pill daily"
10964771|NCT00879060|OG000|Outcome|Spironolactone|Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued.
10964772|NCT00879060|OG001|Outcome|Placebo Control|Placebo group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of placebo.
10964773|NCT00879060|EG000|Reported Event|Spironolactone|Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued.
10964774|NCT00879060|EG001|Reported Event|Control Group|A control population of age and gender-matched volunteers recruited from the general medicine outpatient clinic at Tufts Medical Center as well as from Tufts Medical Center employees. Controls will be excluded if any history of heart disease or any risk factors for cardiovascular disease, conditions of physiological or pathological activation of collagen turnover. Control subjects will have a one time blood draw of 16mL (3 teaspoons).
10964775|NCT00879190|BG000|Baseline|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
10964776|NCT00879190|BG001|Baseline|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
10964777|NCT00879190|BG002|Baseline|Total|Total of all reporting groups
10964778|NCT00879190|FG000|Participant Flow|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
10964779|NCT00879190|FG001|Participant Flow|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
10964780|NCT00879190|OG000|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
10964781|NCT00879190|OG001|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
10964782|NCT00879190|EG000|Reported Event|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
10964783|NCT00879190|EG001|Reported Event|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
10964784|NCT00879229|BG000|Baseline|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
10964785|NCT00879229|BG001|Baseline|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
10964786|NCT00879229|BG002|Baseline|Total|Total of all reporting groups
10964787|NCT00879229|FG000|Participant Flow|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
10964788|NCT00879229|FG001|Participant Flow|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
10964789|NCT00879229|OG000|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
10964790|NCT00879229|OG001|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
10964791|NCT00879229|EG000|Reported Event|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
10964792|NCT00879229|EG001|Reported Event|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
11194796|NCT02154139|BG000|Baseline|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
11194797|NCT02154139|FG000|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
10964793|NCT00879255|BG000|Baseline|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
10964794|NCT00879255|BG001|Baseline|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
10964795|NCT00879255|BG002|Baseline|Total|Total of all reporting groups
10964796|NCT00879255|FG000|Participant Flow|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
10964797|NCT00879255|FG001|Participant Flow|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
10964798|NCT00879255|OG000|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
10964799|NCT00879255|OG001|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
10964800|NCT00879255|EG000|Reported Event|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
10964801|NCT00879255|EG001|Reported Event|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
10964802|NCT00879333|BG000|Baseline|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
10964803|NCT00879333|BG001|Baseline|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
11194798|NCT02154139|OG000|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
11194799|NCT02154139|EG000|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
11194800|NCT02154243|BG000|Baseline|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
11194801|NCT02154243|BG001|Baseline|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
10964804|NCT00879333|BG002|Baseline|Total|Total of all reporting groups
11194802|NCT02154243|BG002|Baseline|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
11194803|NCT02154243|BG003|Baseline|Total|Total of all reporting groups
11241069|NCT02484690|OG000|Outcome|Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)|Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
10802222|NCT02351180|EG000|Reported Event|Inhaled Beclomethasone|"Inhaled beclomethasone 320 mcg twice daily for 180 days.~Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection"
10802223|NCT02351180|EG001|Reported Event|Placebo|"Inhaled placebo twice daily for 180 days.~Placebo: Placebo will serve as a control treatment"
10802224|NCT02337764|BG000|Baseline|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
10802225|NCT02337764|FG000|Participant Flow|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
10802226|NCT02337764|OG000|Outcome|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
10802227|NCT02337764|EG000|Reported Event|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
10802228|NCT02337738|BG000|Baseline|Placebo|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, one placebo tablet once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802229|NCT02337738|BG001|Baseline|TVP-1012 0.5 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 0.5 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802230|NCT02337738|BG002|Baseline|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802231|NCT02337738|BG003|Baseline|Total|Total of all reporting groups
10802232|NCT02337738|FG000|Participant Flow|Placebo|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, one placebo tablet once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802233|NCT02337738|FG001|Participant Flow|TVP-1012 0.5 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 0.5 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802234|NCT02337738|FG002|Participant Flow|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802235|NCT02337738|OG000|Outcome|Placebo|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, one placebo tablet once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802236|NCT02337738|OG001|Outcome|TVP-1012 0.5 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 0.5 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802237|NCT02337738|OG002|Outcome|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802238|NCT02337738|EG000|Reported Event|Placebo|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, one placebo tablet once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802239|NCT02337738|EG001|Reported Event|TVP-1012 0.5 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 0.5 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802240|NCT02337738|EG002|Reported Event|TVP-1012 1 mg|For 2 weeks during the run-in period, followed by 26 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet
10802241|NCT02332187|BG000|Baseline|Sham Electrical Stimulation|"The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Sham electrical stimulation using an All Stim stimulator: With this intervention the All Stim unit is turned off and no electrical stimulation is provided."
10802242|NCT02332187|BG001|Baseline|Active Electrical Stimulation|"The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Active electrical stimulation using an All Stim stimulator: This is an FDA approved stimulator that is used for strengthening the quadriceps muscle."
10802243|NCT02332187|BG002|Baseline|Total|Total of all reporting groups
10802244|NCT02332187|FG000|Participant Flow|Sham Electrical Stimulation|"The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Sham electrical stimulation using an All Stim stimulator: With this intervention the All Stim unit is turned off and no electrical stimulation is provided."
10802245|NCT02332187|FG001|Participant Flow|Active Electrical Stimulation|"The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Active electrical stimulation using an All Stim stimulator: This is an FDA approved stimulator that is used for strengthening the quadriceps muscle."
10802246|NCT02332187|OG000|Outcome|Sham Electrical Stimulation|"The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Sham electrical stimulation using an All Stim stimulator: With this intervention the All Stim unit is turned off and no electrical stimulation is provided."
10802247|NCT02332187|OG001|Outcome|Active Electrical Stimulation|"The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Active electrical stimulation using an All Stim stimulator: This is an FDA approved stimulator that is used for strengthening the quadriceps muscle."
10964805|NCT00879333|FG000|Participant Flow|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
10964806|NCT00879333|FG001|Participant Flow|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
10964807|NCT00879333|OG000|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
10964808|NCT00879333|OG001|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
10964809|NCT00879333|OG001|Outcome|Everolimus 5 mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 1 5 mg tablet of everolimus once daily. Two of the 18 patients on the 5 mg arm, only had pre-dose evaluable samples.
10964810|NCT00879333|OG001|Outcome|Everolimus 5mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 5 mg tablet of everolimus once daily. One of the 11 patients on the 5 mg arm, only had a pre-dose evaluable sample.
10964811|NCT00879333|EG000|Reported Event|Everolimus 10mg / Daily|Everolimus 10mg / daily
10964812|NCT00879333|EG001|Reported Event|Placebo|Placebo
10964813|NCT00879359|BG000|Baseline|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
10964814|NCT00879359|FG000|Participant Flow|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
10964815|NCT00879359|OG000|Outcome|Maintenance With Bevacizumab|carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
10964816|NCT00879359|OG000|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
10964817|NCT00879359|EG000|Reported Event|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
10964818|NCT00879398|BG000|Baseline|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10964819|NCT00879398|FG000|Participant Flow|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10964820|NCT00879398|OG000|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10964821|NCT00879398|EG000|Reported Event|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
10964822|NCT00879411|BG000|Baseline|Telmisartan, Hydrochlorothiazide|
10964823|NCT00879411|FG000|Participant Flow|Telmisartan, Hydrochlorothiazide|
10964824|NCT00879411|OG000|Outcome|Telmisartan, Hydrochlorothiazide|
10964825|NCT00879411|EG000|Reported Event|Telmisartan, Hydrochlorothiazide|
10964826|NCT00879437|BG000|Baseline|Valproic Acid and Radiation, Followed by Valproic Acid and Bevacizumab|"radiation phase (week 1-6): daily valproic acid and radiation, for approximately 6 weeks post-radiation phase (week 7-10): valproic acid daily maintenance phase (starting week 11): daily valproic acid, and bevacizumab once every 2 weeks; to continue for a maximum duration of 2 years~Valproic acid: Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT.~Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml~Bevacizumab: All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.~Radiation therapy: Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks."
10964827|NCT00879437|FG000|Participant Flow|Diffuse Intrinsic Pontine Gliomas (DIPG)|"Newly diagnosed diffuse intrinsic pontine gliomas; a total of 20 patients enrolled~treatment description: radiation phase (week 1-6): daily valproic acid and radiation, for approximately 6 weeks post-radiation phase (week 7-10): valproic acid daily maintenance phase (starting week 11): daily valproic acid, and bevacizumab once every 2 weeks; to continue for a maximum duration of 2 years~Valproic acid: Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT.~Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml~Bevacizumab: All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.~Radiation therapy: Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks."
10964828|NCT00879437|FG001|Participant Flow|High-grade Gliomas (HGG)|"Newly diagnosed high grade gliomas; a total of 18 patients enrolled~treatment description: radiation phase (week 1-6): daily valproic acid and radiation, for approximately 6 weeks post-radiation phase (week 7-10): valproic acid daily maintenance phase (starting week 11): daily valproic acid, and bevacizumab once every 2 weeks; to continue for a maximum duration of 2 years~Valproic acid: Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT.~Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml~Bevacizumab: All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.~Radiation therapy: Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks."
10964829|NCT00879437|OG000|Outcome|Diffuse Intrinsic Pontine Glioma|20 eligible patients, 19 evaluable patients
10964830|NCT00879437|OG001|Outcome|High-grade Gliomas|18 eligible patients, 17 evaluable patients
10964831|NCT00879437|OG000|Outcome|38 Eligible Patients|38 eligible patients, regardless of tumor type
10964832|NCT00879437|OG000|Outcome|Diffuse Intrinsic Pontine Glioma|20 eligible patients, 16 evaluable patients
10964833|NCT00879437|OG000|Outcome|High-grade Gliomas|18 eligible patients, 14 evaluable patients
10964834|NCT00879437|EG000|Reported Event|38 Eligible Patients|38 eligible patients, regardless of tumor type
10964835|NCT00879645|BG000|Baseline|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
10964836|NCT00879645|BG001|Baseline|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
10964837|NCT00879645|BG002|Baseline|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
10964838|NCT00879645|BG003|Baseline|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
10964839|NCT00879645|BG004|Baseline|Total|Total of all reporting groups
10964840|NCT00879645|FG000|Participant Flow|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
10964841|NCT00879645|FG001|Participant Flow|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
10964842|NCT00879645|FG002|Participant Flow|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
10964843|NCT00879645|FG003|Participant Flow|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
10964844|NCT00879645|OG000|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
10964845|NCT00879645|OG001|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
10964846|NCT00879645|OG002|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
10964847|NCT00879645|OG003|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
10964848|NCT00879645|EG000|Reported Event|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
10964849|NCT00879645|EG001|Reported Event|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
10964850|NCT00879645|EG002|Reported Event|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
10964851|NCT00879645|EG003|Reported Event|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
10964852|NCT00879658|BG000|Baseline|BAF312 10mg (Period 1)|10 mg of BAF given orally o.d. for a period of 6 months
10964853|NCT00879658|BG001|Baseline|BAF312 2 mg (Period 1)|2 mg of BAF given orally o.d. for a period of 6 months
10964854|NCT00879658|BG002|Baseline|BAF312 0.5 mg (Period 1)|0.5 mg of BAF given orally o.d. for a period of 6 months
10964855|NCT00879658|BG003|Baseline|Placebo (Period 1)|Placebo given orally o.d. for a period of 3 months
10964856|NCT00879658|BG004|Baseline|BAF312 1.25 mg (Period 2)|1.25 mg of BAF given orally o.d. for a period of 3 months
10964857|NCT00879658|BG005|Baseline|BAF312 0.25 mg (Period 2)|0.25 mg of BAF given orally o.d. for a period of 3 months
10964858|NCT00879658|BG006|Baseline|Placebo (Period 2)|Placebo given orally o.d. for a period of 6 months
10964859|NCT00879658|BG007|Baseline|Total|Total of all reporting groups
10964860|NCT00879658|FG000|Participant Flow|BAF312 10mg (Period 1)|10 mg of BAF given orally o.d. for a period of 6 months
10964861|NCT00879658|FG001|Participant Flow|BAF312 2 mg (Period 1)|2 mg of BAF given orally o.d. for a period of 6 months
10964862|NCT00879658|FG002|Participant Flow|BAF312 0.5 mg (Period 1)|0.5 mg of BAF given orally o.d. for a period of 6 months
10964863|NCT00879658|FG003|Participant Flow|Placebo (Period 1)|Placebo given orally o.d. for a period of 6 months
10964864|NCT00879658|FG004|Participant Flow|BAF312 1.25 mg (Period 2)|1.25 mg of BAF given orally o.d. for a period of 3 months
10964865|NCT00879658|FG005|Participant Flow|BAF312 0.25 mg (Period 2)|0.25 mg of BAF given orally o.d. for a period of 3 months
10964866|NCT00879658|FG006|Participant Flow|Placebo (Period 2)|Placebo given orally o.d. for a period of 3 months
10964867|NCT00879658|OG000|Outcome|BAF312/Placebo|The dose response relationship among five doses of BAF312 and placebo during 3 months of treatment in patients with RRMS, as measured by the number of combined unique active [MRI] lesions (CUAL).
10964868|NCT00879658|OG000|Outcome|BAF312 10mg|10 mg of BAF given orally o.d.
10964869|NCT00879658|OG001|Outcome|BAF312 2 mg|2 mg of BAF given orally o.d.
10964870|NCT00879658|OG002|Outcome|BAF312 0.5 mg|0.5 mg of BAF given orally o.d.
10964871|NCT00879658|OG003|Outcome|Placebo|Placebo given orally o.d.
10964872|NCT00879658|OG002|Outcome|BAF312 1.25 mg|1.25 mg of BAF given orally o.d.
10964873|NCT00879658|OG003|Outcome|BAF312 0.5 mg|0.5 mg of BAF given orally o.d.
10964874|NCT00879658|OG004|Outcome|BAF312 0.25 mg|0.25 mg of BAF given orally o.d.
10964875|NCT00879658|OG005|Outcome|Placebo|Placebo given orally o.d.
10964876|NCT00879658|OG005|Outcome|Placebo|Placebo-controlled
10964877|NCT00879658|OG003|Outcome|Placebo|Placebo-controlled
10964878|NCT00879658|OG001|Outcome|BAF312 2 mg (Period 1)|2 mg of BAF given orally o.d. for a period of 6 months
10964879|NCT00879658|OG003|Outcome|Placebo|placebo given orally o.d.
10964880|NCT00879658|OG002|Outcome|BAF312 1.2.5 mg|1.25 mg of BAF given orally o.d.
10964881|NCT00879658|EG000|Reported Event|BAF312 10 mg|10 mg of BAF given orally o.d.
10964882|NCT00879658|EG001|Reported Event|BAF312 2 mg|2 mg of BAF given orally o.d.
10964883|NCT00879658|EG002|Reported Event|BAF312 1.25 mg|1.25 mg of BAF given orally o.d.
10964884|NCT00879658|EG003|Reported Event|BAF312 0.5 mg|0.5 mg of BAF given orally o.d.
10964885|NCT00879658|EG004|Reported Event|BAF312 0.25 mg|0.25 mg of BAF given orally o.d.
10964886|NCT00879658|EG005|Reported Event|Placebo|Placebo given orally o.d.
10964887|NCT00879684|BG000|Baseline|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle.
10964888|NCT00879684|FG000|Participant Flow|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964889|NCT00879684|FG001|Participant Flow|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964890|NCT00879684|FG002|Participant Flow|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964891|NCT00879684|FG003|Participant Flow|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964892|NCT00879684|FG004|Participant Flow|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964893|NCT00879684|FG005|Participant Flow|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964894|NCT00879684|FG006|Participant Flow|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
10964895|NCT00879684|OG000|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964896|NCT00879684|OG001|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964897|NCT00879684|OG002|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964898|NCT00879684|OG003|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964899|NCT00879684|OG004|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964900|NCT00879684|OG005|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964901|NCT00879684|OG006|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
10964902|NCT00879684|OG005|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
10964903|NCT00879684|OG000|Outcome|CVX-060 (Stage 1)|All participants who received 0.3, 1, 3, 6, 12, 15 mg/kg intravenous infusion once-weekly in Stage 1. Participants who discontinued treatment at any time were followed for 6 weeks to assess toxicity, pharmacokinetics (elimination half-life), and immunogenicity.
10964904|NCT00879684|OG000|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
10964905|NCT00879684|EG000|Reported Event|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964906|NCT00879684|EG001|Reported Event|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964907|NCT00879684|EG002|Reported Event|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964908|NCT00879684|EG003|Reported Event|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964909|NCT00879684|EG004|Reported Event|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964910|NCT00879684|EG005|Reported Event|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
10964911|NCT00879684|EG006|Reported Event|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
10964912|NCT00879697|BG000|Baseline|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
10964913|NCT00879697|BG001|Baseline|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
10964914|NCT00879697|BG002|Baseline|Total|Total of all reporting groups
10964915|NCT00879697|FG000|Participant Flow|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
10964916|NCT00879697|FG001|Participant Flow|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
10964917|NCT00879697|OG000|Outcome|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
10964918|NCT00879697|OG001|Outcome|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
10964919|NCT00879697|EG000|Reported Event|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
10964920|NCT00879697|EG001|Reported Event|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
10964921|NCT00879710|BG000|Baseline|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964922|NCT00879710|BG001|Baseline|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964923|NCT00879710|BG002|Baseline|Total|Total of all reporting groups
10964924|NCT00879710|FG000|Participant Flow|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
10964925|NCT00879710|FG001|Participant Flow|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
10964926|NCT00879710|FG002|Participant Flow|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
10964927|NCT00879710|FG003|Participant Flow|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
10964928|NCT00879710|OG000|Outcome|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964929|NCT00879710|OG001|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964930|NCT00879710|OG000|Outcome|Subjects With Type 1 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964931|NCT00879710|OG001|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964932|NCT00879710|EG000|Reported Event|Subjects With Type 1 Diabetes Mellitus|"Simvastatin 40 mg tablet/ezetimibe 10 mg by mouth daily for 6 weeks,~4 weeks washout period in between~Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964933|NCT00879710|EG001|Reported Event|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet/ezetimibe 10 mg by mouth daily for 6 weeks,~4 weeks washout period in between~Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
10964934|NCT00879775|BG000|Baseline|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
10964935|NCT00879775|BG001|Baseline|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
10964936|NCT00879775|BG002|Baseline|Total|Total of all reporting groups
10964937|NCT00879775|FG000|Participant Flow|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
10964938|NCT00879775|FG001|Participant Flow|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
10964939|NCT00879775|OG000|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
10964940|NCT00879775|OG001|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
10964941|NCT00879775|EG000|Reported Event|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
10964942|NCT00879775|EG001|Reported Event|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
10964943|NCT00879814|BG000|Baseline|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
10964944|NCT00879814|BG001|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
10964945|NCT00879814|BG002|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
10964946|NCT00879814|BG003|Baseline|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
10964947|NCT00879814|BG004|Baseline|Total|Total of all reporting groups
10964948|NCT00879814|FG000|Participant Flow|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
10964949|NCT00879814|FG001|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
10964950|NCT00879814|FG002|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
10964951|NCT00879814|FG003|Participant Flow|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
10964952|NCT00879814|OG000|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
10964953|NCT00879814|OG001|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
10964954|NCT00879814|OG002|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
10964955|NCT00879814|OG003|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
10964956|NCT00879814|EG000|Reported Event|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
10964957|NCT00879814|EG001|Reported Event|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
10964958|NCT00879814|EG002|Reported Event|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
10964959|NCT00879814|EG003|Reported Event|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
10964960|NCT00879879|BG000|Baseline|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
10964961|NCT00879879|FG000|Participant Flow|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
10964962|NCT00879879|OG000|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
11194804|NCT02154243|FG000|Participant Flow|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
10964963|NCT00879879|OG000|Outcome|Losartan|50 mg tablets of losartan taken daily by mouth for 1 year
10964964|NCT00879879|OG000|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~Change in secondary markers of lung function over 12 months of losartan therapy, N=17~N (%) Stable 6 (35.29) Improved 5 (29.41) Deteriorated 6 (-1.38)"
10964965|NCT00879879|EG000|Reported Event|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
10964966|NCT00879970|BG000|Baseline|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
10964967|NCT00879970|BG001|Baseline|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964968|NCT00879970|BG002|Baseline|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
10964969|NCT00879970|BG003|Baseline|Total|Total of all reporting groups
10964970|NCT00879970|FG000|Participant Flow|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
10964971|NCT00879970|FG001|Participant Flow|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964972|NCT00879970|FG002|Participant Flow|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
10964973|NCT00879970|FG003|Participant Flow|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
10964974|NCT00879970|FG004|Participant Flow|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
10964975|NCT00879970|OG000|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
10964976|NCT00879970|OG001|Outcome|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964977|NCT00879970|OG002|Outcome|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
10964978|NCT00879970|OG003|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
10964979|NCT00879970|OG004|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
10964980|NCT00879970|OG000|Outcome|Placebo|PLACEBO Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
10964981|NCT00879970|OG001|Outcome|Pioglitzaone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964982|NCT00879970|OG002|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
10964983|NCT00879970|OG001|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964984|NCT00879970|OG003|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
10964985|NCT00879970|OG004|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
10964986|NCT00879970|EG000|Reported Event|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
10964987|NCT00879970|EG001|Reported Event|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
10964988|NCT00879970|EG002|Reported Event|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
10964989|NCT00879970|EG003|Reported Event|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days
10964990|NCT00879970|EG004|Reported Event|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
10964991|NCT00879996|BG000|Baseline|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
10964992|NCT00879996|BG001|Baseline|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
10964993|NCT00879996|BG002|Baseline|Total|Total of all reporting groups
10964994|NCT00879996|FG000|Participant Flow|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
10964995|NCT00879996|FG001|Participant Flow|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
10964996|NCT00879996|OG000|Outcome|Methadone|Methadone 10-60 mg per day divided in 2-4 doses for 6 months
10964997|NCT00879996|OG001|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
10964998|NCT00879996|OG000|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
10964999|NCT00879996|OG001|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
11382445|NCT01015833|BG000|Baseline|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
11382446|NCT01015833|BG001|Baseline|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10802248|NCT02332187|EG000|Reported Event|Sham Electrical Stimulation|"The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Sham electrical stimulation using an All Stim stimulator: With this intervention the All Stim unit is turned off and no electrical stimulation is provided."
10802249|NCT02332187|EG001|Reported Event|Active Electrical Stimulation|"The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.~Active electrical stimulation using an All Stim stimulator: This is an FDA approved stimulator that is used for strengthening the quadriceps muscle."
10850658|NCT00303901|FG000|Participant Flow|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
10850659|NCT00303901|OG000|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
10850660|NCT00303901|EG000|Reported Event|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
10850661|NCT00303953|BG000|Baseline|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
10850662|NCT00303953|FG000|Participant Flow|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
10850663|NCT00303953|OG000|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
10850664|NCT00303953|EG000|Reported Event|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
10850665|NCT00303966|BG000|Baseline|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10850666|NCT00303966|FG000|Participant Flow|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10850667|NCT00303966|OG000|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10850668|NCT00303966|EG000|Reported Event|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
10850669|NCT00303979|BG000|Baseline|Cohort A (Baseline, 12 and 24 Months)|Cohort A: The charts of 15,177 patients were reviewed at baseline, 12 months and 24 months. The principal investigator and HF nurse of the study sites attended an educational workshop at baseline, 12 and 24 months as well where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort A is a longitudinal cohort.
10850670|NCT00303979|BG001|Baseline|Cohort B (6 Months)|Cohort B: The charts of 9,992 patients were reviewed at 6 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort B is a single time point cohort.
10850671|NCT00303979|BG002|Baseline|Cohort C (18 Months)|Cohort C: The charts of 9,641 patients were reviewed at 18 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort C is a single time point cohort.
10850672|NCT00303979|BG003|Baseline|Total|Total of all reporting groups
10850673|NCT00303979|FG000|Participant Flow|Cohort A (Baseline, 12 and 24 Months)|Cohort A: The charts of 15,177 patients were reviewed at baseline, 12 months and 24 months. The principal investigator and HF nurse of the study sites attended an educational workshop at baseline, 12 and 24 months as well where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort A is a longitudinal cohort.
10850674|NCT00303979|FG001|Participant Flow|Cohort B (6 Months)|Cohort B: The charts of 9,992 patients were reviewed at 6 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort B is a single time point cohort.
10850675|NCT00303979|FG002|Participant Flow|Cohort C (18 Months)|Cohort C: The charts of 9,641 patients were reviewed at 18 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort C is a single time point cohort.
10965000|NCT00879996|EG000|Reported Event|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
10965001|NCT00879996|EG001|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
10965002|NCT00880009|BG000|Baseline|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965003|NCT00880009|FG000|Participant Flow|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965004|NCT00880009|OG000|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965005|NCT00880009|OG001|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965006|NCT00880009|OG000|Outcome|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965007|NCT00880009|OG000|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965008|NCT00880009|EG000|Reported Event|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10965009|NCT00880022|BG000|Baseline|Arm Compression Only|
10965010|NCT00880022|BG001|Baseline|Arm, Trunck and Chest Compression|
10965011|NCT00880022|BG002|Baseline|Total|Total of all reporting groups
10965012|NCT00880022|FG000|Participant Flow|Arm Compression Only|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
10965013|NCT00880022|FG001|Participant Flow|Arm, Trunk and Chest Compression|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
10965014|NCT00880022|OG000|Outcome|Arm Compression Only|
10965015|NCT00880022|OG001|Outcome|Arm, Trunck and Chest Compression|
10965016|NCT00880022|OG000|Outcome|Arm Compression Only|Compression in Arm only
10965017|NCT00880022|OG001|Outcome|Arm, Trunk and Chest Compression|Compression in arm, trunk and chest compression
10965018|NCT00880022|EG000|Reported Event|Arm Compression Only|
11194805|NCT02154243|FG001|Participant Flow|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
11194806|NCT02154243|FG002|Participant Flow|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
11382447|NCT01015833|BG002|Baseline|Total|Total of all reporting groups
10965019|NCT00880022|EG001|Reported Event|Arm, Trunck and Chest Compression|
10965020|NCT00880048|BG000|Baseline|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
10965021|NCT00880048|BG001|Baseline|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
10965022|NCT00880048|BG002|Baseline|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
10965023|NCT00880048|BG003|Baseline|Total|Total of all reporting groups
10965024|NCT00880048|FG000|Participant Flow|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
10965025|NCT00880048|FG001|Participant Flow|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
10965026|NCT00880048|FG002|Participant Flow|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
10965027|NCT00880048|OG000|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
10965028|NCT00880048|OG001|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
10965029|NCT00880048|OG002|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
10965030|NCT00880048|EG000|Reported Event|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
10965031|NCT00880048|EG001|Reported Event|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
10965032|NCT00880048|EG002|Reported Event|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
10965033|NCT00880087|BG000|Baseline|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
11194807|NCT02154243|OG000|Outcome|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
11194808|NCT02154243|OG001|Outcome|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
11194809|NCT02154243|OG002|Outcome|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
11241070|NCT02484690|OG001|Outcome|Arm B: Faricimab, 1.5 mg Q4W|Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
10802250|NCT02227875|BG000|Baseline|Mylan's Insulin Glargine|"receive Mylan's insulin Glargine~Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential."
10802251|NCT02227875|BG001|Baseline|Lantus®|"receive Lantus®~Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period."
10802252|NCT02227875|BG002|Baseline|Total|Total of all reporting groups
10802253|NCT02227875|FG000|Participant Flow|Mylan's Insulin Glargine|"receive Mylan's insulin Glargine~Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential."
10802254|NCT02227875|FG001|Participant Flow|Lantus®|"receive Lantus®~Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period."
10802255|NCT02227875|OG000|Outcome|Mylan's Insulin Glargine|"receive Mylan's insulin Glargine~Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential."
10802256|NCT02227875|OG001|Outcome|Lantus®|"receive Lantus®~Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period."
10802257|NCT02227875|EG000|Reported Event|Mylan's Insulin Glargine|"receive Mylan's insulin Glargine~Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential."
10802258|NCT02227875|EG001|Reported Event|Lantus®|"receive Lantus®~Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period."
10802259|NCT02227862|BG000|Baseline|Mylan's Insulin Glargine|"Receive Mylan's Insulin Glargine plus insulin lispro.~Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802260|NCT02227862|BG001|Baseline|Lantus®|"Receive Lantus® plus insulin lispro~Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802261|NCT02227862|BG002|Baseline|Total|Total of all reporting groups
10802262|NCT02227862|FG000|Participant Flow|Mylan's Insulin Glargine|"Receive Mylan's Insulin Glargine plus insulin lispro.~Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802263|NCT02227862|FG001|Participant Flow|Lantus®|"Receive Lantus® plus insulin lispro~Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802264|NCT02227862|OG000|Outcome|Mylan's Insulin Glargine|"Receive Mylan's Insulin Glargine plus insulin lispro.~Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10965034|NCT00880087|BG001|Baseline|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10965035|NCT00880087|BG002|Baseline|Total|Total of all reporting groups
10965036|NCT00880087|FG000|Participant Flow|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10965037|NCT00880087|FG001|Participant Flow|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10965038|NCT00880087|OG000|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10965039|NCT00880087|OG001|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10965040|NCT00880087|EG000|Reported Event|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
10965041|NCT00880087|EG001|Reported Event|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
10965042|NCT00880100|BG000|Baseline|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
10965043|NCT00880100|FG000|Participant Flow|Ultrase® MT12|Patients received usual pancreatic enzymes therapy for 9 to 14 days during baseline phase followed by Ultrase® MT12 capsules orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
10965044|NCT00880100|OG000|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
10965045|NCT00880100|EG000|Reported Event|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
10965046|NCT00880165|BG000|Baseline|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
10965047|NCT00880165|BG001|Baseline|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
10965048|NCT00880165|BG002|Baseline|Total|Total of all reporting groups
10965049|NCT00880165|FG000|Participant Flow|In-laboratory Testing|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
10965050|NCT00880165|FG001|Participant Flow|Home Unattended Testing|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
10965051|NCT00880165|OG000|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
10965052|NCT00880165|OG001|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
10965053|NCT00880165|EG000|Reported Event|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
10965054|NCT00880165|EG001|Reported Event|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
11194810|NCT02154243|EG000|Reported Event|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.~Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
10965055|NCT00880191|BG000|Baseline|Gabapentin|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.> dexamethasone: Given orally> gabapentin: Given orally
10965056|NCT00880191|BG001|Baseline|Placebo|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.> dexamethasone: Given orally> placebo: Given orally
10965057|NCT00880191|BG002|Baseline|Total|Total of all reporting groups
10965058|NCT00880191|FG000|Participant Flow|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
10965059|NCT00880191|FG001|Participant Flow|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
10965060|NCT00880191|OG000|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
10965061|NCT00880191|OG001|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
10965062|NCT00880191|EG000|Reported Event|Gabapentin|gabapentin: Given orally
10965063|NCT00880191|EG001|Reported Event|Placebo|placebo: Given orally
10965064|NCT00880230|BG000|Baseline|Scuba Iliac Stent System|"Device: Scuba™ Iliac stent~Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
10965065|NCT00880230|FG000|Participant Flow|Scuba Iliac Stent System|"Device: Scuba Iliac Stent~Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
10965066|NCT00880230|OG000|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
10965067|NCT00880230|EG000|Reported Event|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
10965068|NCT00880256|BG000|Baseline|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
10965069|NCT00880256|FG000|Participant Flow|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
10965070|NCT00880256|OG000|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
10965071|NCT00880256|EG000|Reported Event|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
10965072|NCT00880269|BG000|Baseline|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
10965073|NCT00880269|BG001|Baseline|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
10965074|NCT00880269|BG002|Baseline|Total|Total of all reporting groups
10965075|NCT00880269|FG000|Participant Flow|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
10965076|NCT00880269|FG001|Participant Flow|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
10965077|NCT00880269|OG000|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
10965078|NCT00880269|OG001|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
10965079|NCT00880269|EG000|Reported Event|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
10965080|NCT00880269|EG001|Reported Event|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
10965081|NCT00880334|BG000|Baseline|Vandetanib & Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
10965082|NCT00880334|BG001|Baseline|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
10965083|NCT00880334|BG002|Baseline|Total|Total of all reporting groups
10965084|NCT00880334|FG000|Participant Flow|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
10965085|NCT00880334|FG001|Participant Flow|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day~Eligible participants were allowed to crossover to single agent vandetanib."
10965086|NCT00880334|OG000|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
10965087|NCT00880334|OG001|Outcome|Placebo and Docetaxel|"Placebo orally and docetaxel intravenously~Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
10965088|NCT00880334|OG000|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
10965089|NCT00880334|OG001|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
10965090|NCT00880334|OG001|Outcome|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
10965091|NCT00880334|EG000|Reported Event|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
10965092|NCT00880334|EG001|Reported Event|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
10965093|NCT00880334|EG002|Reported Event|Placebo and Docetaxel-Crossover|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
10965094|NCT00880360|BG000|Baseline|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
10965095|NCT00880360|FG000|Participant Flow|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
10965096|NCT00880360|OG000|Outcome|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
10965097|NCT00880360|OG000|Outcome|Ontak|Ontak: Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
10965098|NCT00880360|EG000|Reported Event|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
10965099|NCT00880399|BG000|Baseline|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965100|NCT00880399|BG001|Baseline|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965101|NCT00880399|BG002|Baseline|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965102|NCT00880399|BG003|Baseline|Total|Total of all reporting groups
10965103|NCT00880399|FG000|Participant Flow|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965104|NCT00880399|FG001|Participant Flow|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965105|NCT00880399|FG002|Participant Flow|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965106|NCT00880399|OG000|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965107|NCT00880399|OG001|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965108|NCT00880399|OG002|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965109|NCT00880399|EG000|Reported Event|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965110|NCT00880399|EG001|Reported Event|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965111|NCT00880399|EG002|Reported Event|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
10965112|NCT00880425|BG000|Baseline|Chronic Daily Headache|Patients who fulfilled criteria for Chronic Migraine, New Daily Persistent Headache , Chronic Post Traumatic Headache or Chronic Tension Type Headache
10965113|NCT00880425|FG000|Participant Flow|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965114|NCT00880425|FG001|Participant Flow|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965115|NCT00880425|OG000|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965116|NCT00880425|OG001|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965117|NCT00880425|EG000|Reported Event|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965118|NCT00880425|EG001|Reported Event|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
10965119|NCT00880464|BG000|Baseline|Metastatic Breast Cancer Cohort|"Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS"
11241071|NCT02484690|OG002|Outcome|Arm C: Faricimab, 6 mg Q4W|Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
10965120|NCT00880464|FG000|Participant Flow|Stage II-III Breast Cancer Cohort|"Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS"
10965121|NCT00880464|OG000|Outcome|Vaccine|"Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS"
10965122|NCT00880464|EG000|Reported Event|Vaccine|"Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out~Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS"
10965123|NCT00880555|BG000|Baseline|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
10965124|NCT00880555|BG001|Baseline|Arm 2: Control|Elderly controls without memory impairment
10965125|NCT00880555|BG002|Baseline|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
10965126|NCT00880555|BG003|Baseline|Total|Total of all reporting groups
10965127|NCT00880555|FG000|Participant Flow|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
10965128|NCT00880555|FG001|Participant Flow|Arm 2: Control|Elderly controls without memory impairment
11194811|NCT02154243|EG001|Reported Event|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.~Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
10965129|NCT00880555|FG002|Participant Flow|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
10965130|NCT00880555|FG003|Participant Flow|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
10965131|NCT00880555|FG004|Participant Flow|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
10965132|NCT00880555|FG005|Participant Flow|Non-AD Dementia|Other causes of dementia
10965133|NCT00880555|OG000|Outcome|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
10965134|NCT00880555|OG001|Outcome|Arm 2: Control|Elderly controls without memory impairment
10965135|NCT00880555|OG002|Outcome|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
10965136|NCT00880555|EG000|Reported Event|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
10965137|NCT00880555|EG001|Reported Event|Arm 2: Control|Elderly controls without memory impairment
10965138|NCT00880555|EG002|Reported Event|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
10965139|NCT00880555|EG003|Reported Event|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
10965140|NCT00880555|EG004|Reported Event|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
10965141|NCT00880555|EG005|Reported Event|Non-AD Dementia|Other causes of dementia
10965142|NCT00880568|BG000|Baseline|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
10965143|NCT00880568|BG001|Baseline|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
10965144|NCT00880568|BG002|Baseline|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
10965145|NCT00880568|BG003|Baseline|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
10965146|NCT00880568|BG004|Baseline|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965147|NCT00880568|BG005|Baseline|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965148|NCT00880568|BG006|Baseline|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965149|NCT00880568|BG007|Baseline|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965150|NCT00880568|BG008|Baseline|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965151|NCT00880568|BG009|Baseline|Total|Total of all reporting groups
10965152|NCT00880568|FG000|Participant Flow|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
10965153|NCT00880568|FG001|Participant Flow|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
10965154|NCT00880568|FG002|Participant Flow|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
10965155|NCT00880568|FG003|Participant Flow|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
10965156|NCT00880568|FG004|Participant Flow|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965157|NCT00880568|FG005|Participant Flow|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965158|NCT00880568|FG006|Participant Flow|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965159|NCT00880568|FG007|Participant Flow|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965160|NCT00880568|FG008|Participant Flow|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965161|NCT00880568|OG000|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
10965162|NCT00880568|OG001|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
10965163|NCT00880568|OG002|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
10965164|NCT00880568|OG003|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
10965165|NCT00880568|OG004|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965166|NCT00880568|OG005|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965167|NCT00880568|OG006|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965168|NCT00880568|OG007|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965169|NCT00880568|OG008|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965170|NCT00880568|OG000|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965171|NCT00880568|OG001|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965172|NCT00880568|OG002|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965173|NCT00880568|OG003|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965174|NCT00880568|OG004|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965175|NCT00880568|EG000|Reported Event|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
10965176|NCT00880568|EG001|Reported Event|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
10965177|NCT00880568|EG002|Reported Event|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
10965178|NCT00880568|EG003|Reported Event|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
10965179|NCT00880568|EG004|Reported Event|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965180|NCT00880568|EG005|Reported Event|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965181|NCT00880568|EG006|Reported Event|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965182|NCT00880568|EG007|Reported Event|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965183|NCT00880568|EG008|Reported Event|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
10965184|NCT00880581|BG000|Baseline|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
10965185|NCT00880581|FG000|Participant Flow|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 (CpG 7909 or ProMune) at 18 mg per week over 10 weeks in combination with local radiation [2 gray (2Gy) on each of Days 1 and 2] as a therapy for low-grade B-cell lymphoma.
10965186|NCT00880581|OG000|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.~PF-3512676: 18 mg injection~Local radiotherapy: 2 x 2 Gy"
10965187|NCT00880581|EG000|Reported Event|PF-3512676|Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
10965188|NCT00880607|BG000|Baseline|Intrathecal Morphine|"Receives a single dose of intrathecal morphine~Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain."
10965189|NCT00880607|BG001|Baseline|DepoDur|"Receives DepoDur extended release morphine for pain management~DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients."
10965190|NCT00880607|BG002|Baseline|Total|Total of all reporting groups
10965191|NCT00880607|FG000|Participant Flow|Intrathecal Morphine|"Receives a single dose of intrathecal morphine~Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain."
10965192|NCT00880607|FG001|Participant Flow|DepoDur|"Receives DepoDur extended release morphine for pain management~DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients."
10965193|NCT00880607|OG000|Outcome|Intrathecal Morphine|"single dose of intrathecal morphine~Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain."
10965194|NCT00880607|OG001|Outcome|EREM|"Receives extended release epidural morphine for pain management~DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients."
10965195|NCT00880607|OG000|Outcome|Intrathecal Morphine|"Intrathecal morphine~Receives a single dose of intrathecal morphine"
11194812|NCT02154243|EG002|Reported Event|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
10965196|NCT00880607|OG001|Outcome|EREM|extended-release epidural morphine is marketed as DepoDurTM which is a preservative-free sterile suspension of multivesicular liposomes (DepoFoam®) containing morphine, intended for epidural administration. DepoFoam consists of lipid-based particles containing discrete water-filled chambers dispersed through the lipid matrix. The lipids are naturally occurring substances such as phospholipids and triglycerides. The small amount of lipid is cleared rapidly in the body as the particles deliver their drug payload
10965197|NCT00880607|EG000|Reported Event|Intrathecal Morphine|"Receives a single dose of intrathecal morphine~Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain."
10965198|NCT00880607|EG001|Reported Event|DepoDur|"Receives DepoDur extended release morphine for pain management~DepoDur: DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients."
10965199|NCT00880620|BG000|Baseline|Placebo|Placebo capsules were used
10965200|NCT00880620|BG001|Baseline|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
10965201|NCT00880620|BG002|Baseline|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
10965202|NCT00880620|BG003|Baseline|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
10965203|NCT00880620|BG004|Baseline|Total|Total of all reporting groups
10965204|NCT00880620|FG000|Participant Flow|Placebo|Placebo capsules were used
10965205|NCT00880620|FG001|Participant Flow|IPX066 145 mg LD|IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa
10965206|NCT00880620|FG002|Participant Flow|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
10965207|NCT00880620|FG003|Participant Flow|IPX066 390 mg LD|IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa
10965208|NCT00880620|OG000|Outcome|Placebo|Placebo capsules were used
10965209|NCT00880620|OG001|Outcome|IPX066 145mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
10965210|NCT00880620|OG002|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
10965211|NCT00880620|OG003|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
10965212|NCT00880620|OG000|Outcome|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
10965213|NCT00880620|OG001|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
10965214|NCT00880620|OG002|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
10965215|NCT00880620|OG003|Outcome|Placebo|Placebo capsules were used
10965216|NCT00880620|EG000|Reported Event|Placebo|Placebo capsules were used
10965217|NCT00880620|EG001|Reported Event|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
10965218|NCT00880620|EG002|Reported Event|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
10965219|NCT00880620|EG003|Reported Event|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
10965220|NCT00880685|BG000|Baseline|Memantine 10mg-30mg|Memantine 10mg-30mg (active drug)
10965221|NCT00880685|FG000|Participant Flow|Memantine 10mg-30mg|Memantine 10mg-30mg (active drug)
10965222|NCT00880685|OG000|Outcome|Memantine 10mg-30mg|Memantine 10mg-30mg (study drug)
10965223|NCT00880685|OG000|Outcome|Memantine|"Memantine 10-30mg~Memantine: 10-30mg, daily for 8 weeks"
10965224|NCT00880685|EG000|Reported Event|Memantine 10mg|Memantine 10mg (study drug)
10965225|NCT00880685|EG001|Reported Event|Memantine 20mg|Memantine 20mg (study drug)
10965226|NCT00880685|EG002|Reported Event|Memantine 30mg|Memantine 30mg (study drug)
10965227|NCT00880698|BG000|Baseline|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965228|NCT00880698|BG001|Baseline|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965229|NCT00880698|BG002|Baseline|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965230|NCT00880698|BG003|Baseline|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965231|NCT00880698|BG004|Baseline|Total|Total of all reporting groups
10965232|NCT00880698|FG000|Participant Flow|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965233|NCT00880698|FG001|Participant Flow|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965234|NCT00880698|FG002|Participant Flow|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965235|NCT00880698|FG003|Participant Flow|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965236|NCT00880698|OG000|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965237|NCT00880698|OG001|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965238|NCT00880698|OG002|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965239|NCT00880698|OG003|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965240|NCT00880698|OG000|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
10965241|NCT00880698|OG001|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
10965242|NCT00880698|EG000|Reported Event|HIV-1 Uninfected RotaTeq|
11382448|NCT01015833|FG000|Participant Flow|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
10965243|NCT00880698|EG001|Reported Event|HIV-1 Uninfected Placebo|
10965244|NCT00880698|EG002|Reported Event|HIV-1 Infected RotaTeq|
10965245|NCT00880698|EG003|Reported Event|HIV-1 Infected Placebo|
10965246|NCT00880750|BG000|Baseline|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
10965247|NCT00880750|BG001|Baseline|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
10965248|NCT00880750|BG002|Baseline|Total|Total of all reporting groups
10965249|NCT00880750|FG000|Participant Flow|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
10965250|NCT00880750|FG001|Participant Flow|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
10965251|NCT00880750|OG000|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
10965252|NCT00880750|OG001|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
10965253|NCT00880750|EG000|Reported Event|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
10965254|NCT00880750|EG001|Reported Event|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
10965255|NCT00880763|BG000|Baseline|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965256|NCT00880763|BG001|Baseline|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965257|NCT00880763|BG002|Baseline|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965258|NCT00880763|BG003|Baseline|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965259|NCT00880763|BG004|Baseline|Total|Total of all reporting groups
10965260|NCT00880763|FG000|Participant Flow|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965261|NCT00880763|FG001|Participant Flow|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965262|NCT00880763|FG002|Participant Flow|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965263|NCT00880763|FG003|Participant Flow|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965264|NCT00880763|OG000|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965265|NCT00880763|OG001|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965266|NCT00880763|OG002|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965267|NCT00880763|OG003|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965268|NCT00880763|EG000|Reported Event|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965269|NCT00880763|EG001|Reported Event|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965270|NCT00880763|EG002|Reported Event|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965271|NCT00880763|EG003|Reported Event|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
10965272|NCT00880906|BG000|Baseline|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
10965273|NCT00880906|BG001|Baseline|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
10965274|NCT00880906|BG002|Baseline|Total|Total of all reporting groups
10965275|NCT00880906|FG000|Participant Flow|Group A Drug Therapy Plus Dilation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
10965276|NCT00880906|FG001|Participant Flow|Group B Drug Therapy Only|Receives steroids and PPI only- Does not have esophageal dilation.
10965277|NCT00880906|OG000|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
10965278|NCT00880906|OG001|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
10965279|NCT00880906|EG000|Reported Event|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
10965280|NCT00880906|EG001|Reported Event|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
10965281|NCT00880919|BG000|Baseline|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
10965282|NCT00880919|BG001|Baseline|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
10965283|NCT00880919|BG002|Baseline|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
10965284|NCT00880919|BG003|Baseline|Total|Total of all reporting groups
10965285|NCT00880919|FG000|Participant Flow|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
10965286|NCT00880919|FG001|Participant Flow|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
10965287|NCT00880919|FG002|Participant Flow|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
10965288|NCT00880919|OG000|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
10965289|NCT00880919|OG001|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
10965290|NCT00880919|OG002|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
10965291|NCT00880919|OG000|Outcome|Quetiapine XR 150 mg/Day (n=33)|"Seroquel XR 150mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
10965292|NCT00880919|OG001|Outcome|Quetiapine XR 300 mg/Day (n=33)|"Seroquel XR 300mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
10965293|NCT00880919|OG002|Outcome|Placebo (n=29)|"Equivalent number of placebo oral tablets taken daily for 8 weeks.~Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
10965294|NCT00880919|EG000|Reported Event|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
10965295|NCT00880919|EG001|Reported Event|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
10965296|NCT00880919|EG002|Reported Event|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
11194813|NCT02154347|BG000|Baseline|Placebo/KAD-1229|"Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.~KAD-1229~Placebo~Insulin"
10965297|NCT00880997|BG000|Baseline|Doxazosin Slow Titration|"Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:~Dox-Slow Group: Participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin over weeks 8-13.~Participants were tapered off doxazosin or placebo over study weeks 14-17."
10965298|NCT00880997|BG001|Baseline|Doxazosin Fast Titration|"Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:~Dox-Fast Group: Participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin over weeks 4-13.~Participants were tapered off doxazosin or placebo over study weeks 14-17."
10965299|NCT00880997|BG002|Baseline|Placebo|"Participants received matched placebo during weeks 1-13.~Participants were tapered off placebo over study weeks 14-17."
10965300|NCT00880997|BG003|Baseline|Total|Total of all reporting groups
10965301|NCT00880997|FG000|Participant Flow|Doxazosin Fast|Participantsreaching the target dose after a 4-week titration period
10965302|NCT00880997|FG001|Participant Flow|Doxazosin Slow|Participants reaching the target dose after an 8-week titration period
10965303|NCT00880997|FG002|Participant Flow|Placebo|Matching placebo
10965304|NCT00880997|OG000|Outcome|DOX-slow Group|Participants reaching the target dose after an 8-week titration period are labeled as the DOX slow group. Participants were stabilized on doxazosin over weeks 8-13 and then tapered off doxazosin over study weeks 14-17.
10965305|NCT00880997|OG001|Outcome|DOX-fast Group|Participants reaching the target dose after a 4-week period are labeled as the DOX-fast group. Participants were stabilized on doxazosin over weeks 4-13 and then tapered off doxazosin over study weeks 14-17.
10965306|NCT00880997|OG002|Outcome|Placebo|Participants took placebo during weeks 1-17.
10965307|NCT00880997|EG000|Reported Event|Dox-Slow Group|Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
10965308|NCT00880997|EG001|Reported Event|Dox-Fast Group:|Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
10965309|NCT00880997|EG002|Reported Event|Placebo|"A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration.~Placebo: Placebo daily dosing"
10965310|NCT00881335|BG000|Baseline|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
10965311|NCT00881335|BG001|Baseline|Control Group|without any intervention
10965312|NCT00881335|BG002|Baseline|Total|Total of all reporting groups
10965313|NCT00881335|FG000|Participant Flow|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
10965314|NCT00881335|FG001|Participant Flow|Control Group|without any intervention
10965315|NCT00881335|OG000|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
10965316|NCT00881335|OG001|Outcome|Control Group|without any intervention
10965317|NCT00881335|EG000|Reported Event|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
10965318|NCT00881335|EG001|Reported Event|Control Group|without any intervention
10965319|NCT00881361|BG000|Baseline|cN1 Cohort|Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965320|NCT00881361|BG001|Baseline|cN2 Cohort|Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965321|NCT00881361|BG002|Baseline|Total|Total of all reporting groups
10965322|NCT00881361|FG000|Participant Flow|cN1 Cohort|Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965323|NCT00881361|FG001|Participant Flow|cN2 Cohort|Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965324|NCT00881361|FG002|Participant Flow|cN3 Patients (Ineligible)|Patients who were staged according to the AJCC staging system as cN3.
10965325|NCT00881361|OG000|Outcome|cN1 Cohort|Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
11194814|NCT02154347|BG001|Baseline|KAD-1229/KAD-1229|"Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.~KAD-1229~Insulin"
10965326|NCT00881361|OG000|Outcome|cN2 Cohort|Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965327|NCT00881361|OG000|Outcome|Post-chemotherapy AUS Normal|Patients with lymph nodes classified as normal if the radiologist was unable to visualize any lymph nodes on axillary ultrasound (AUS) or indicated that the lymph nodes were normal in morphologic appearance.
10965328|NCT00881361|OG001|Outcome|Post-chemotherapy AUS Suspicious|Patients with lymph nodes with abnormal morphology on AUS were classified as suspicious.
10965329|NCT00881361|OG001|Outcome|cN2 Cohort|Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965330|NCT00881361|EG000|Reported Event|cN1 Cohort|Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965331|NCT00881361|EG001|Reported Event|cN2 Cohort|Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
10965332|NCT00881465|BG000|Baseline|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
10965333|NCT00881465|BG001|Baseline|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
10965334|NCT00881465|BG002|Baseline|Total|Total of all reporting groups
10965335|NCT00881465|FG000|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
10965336|NCT00881465|FG001|Participant Flow|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
10965337|NCT00881465|OG000|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
10965338|NCT00881465|OG001|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
10965339|NCT00881465|EG000|Reported Event|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
11194815|NCT02154347|BG002|Baseline|Total|Total of all reporting groups
11194816|NCT02154347|FG000|Participant Flow|Placebo/KAD-1229|"Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.~KAD-1229~Placebo~Insulin"
10965340|NCT00881465|EG001|Reported Event|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
10965341|NCT00881504|BG000|Baseline|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
10965342|NCT00881504|FG000|Participant Flow|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
10965343|NCT00881504|OG000|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
10965344|NCT00881504|EG000|Reported Event|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
10965345|NCT00881530|BG000|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10965346|NCT00881530|BG001|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10965347|NCT00881530|BG002|Baseline|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
10965348|NCT00881530|BG003|Baseline|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965349|NCT00881530|BG004|Baseline|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965350|NCT00881530|BG005|Baseline|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965351|NCT00881530|BG006|Baseline|Total|Total of all reporting groups
10965352|NCT00881530|FG000|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10965353|NCT00881530|FG001|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10965354|NCT00881530|FG002|Participant Flow|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
10965355|NCT00881530|FG003|Participant Flow|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965356|NCT00881530|FG004|Participant Flow|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965357|NCT00881530|FG005|Participant Flow|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965358|NCT00881530|OG000|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10965359|NCT00881530|OG001|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
10965360|NCT00881530|OG002|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
10965361|NCT00881530|OG003|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965362|NCT00881530|OG004|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965363|NCT00881530|OG005|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965364|NCT00881530|EG000|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
10965365|NCT00881530|EG001|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
11194817|NCT02154347|FG001|Participant Flow|KAD-1229/KAD-1229|"Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.~KAD-1229~Insulin"
10965366|NCT00881530|EG002|Reported Event|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
10965367|NCT00881530|EG003|Reported Event|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965368|NCT00881530|EG004|Reported Event|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965369|NCT00881530|EG005|Reported Event|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
10965370|NCT00881569|BG000|Baseline|CS-7017 0.50 mg BID|Participant who received oral CS-7017 0.50 mg twice daily (BID).
10965371|NCT00881569|BG001|Baseline|CS-7017 0.75 mg BID|Participant who received oral CS-7017 0.75 mg twice daily (BID).
10965372|NCT00881569|BG002|Baseline|Total|Total of all reporting groups
10965373|NCT00881569|FG000|Participant Flow|CS-7017 0.75 mg BID|Participant who received oral CS-7017 0.75 mg twice daily (BID).
10965374|NCT00881569|FG001|Participant Flow|CS-7017 0.50 mg BID|Participant who received oral CS-7017 0.50 mg twice daily (BID).
10965375|NCT00881569|OG000|Outcome|CS-7017 0.50 mg BID|Participant who received oral CS-7017 0.50 mg twice daily (BID).
10965376|NCT00881569|OG001|Outcome|CS-7017 0.75 mg BID|Participant who received oral CS-7017 0.75 mg twice daily (BID).
10965377|NCT00881569|EG000|Reported Event|CS-7017 0.50 mg BID|Participant who received oral CS-7017 0.50 mg twice daily (BID).
10965378|NCT00881569|EG001|Reported Event|CS-7017 0.75 mg BID|Participant who received oral CS-7017 0.75 mg twice daily (BID).
10965379|NCT00881621|BG000|Baseline|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
10965380|NCT00881621|FG000|Participant Flow|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
10965381|NCT00881621|OG000|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
10965382|NCT00881621|EG000|Reported Event|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
10965383|NCT00881647|BG000|Baseline|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
10965384|NCT00881647|BG001|Baseline|Waitlist|Participants placed on a waitlist for 8 weeks.
10965385|NCT00881647|BG002|Baseline|Total|Total of all reporting groups
10965386|NCT00881647|FG000|Participant Flow|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
10965387|NCT00881647|FG001|Participant Flow|Waitlist|Participants placed on a waitlist for 8 weeks.
10965388|NCT00881647|OG000|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
10965389|NCT00881647|OG001|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
10965390|NCT00881647|EG000|Reported Event|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
10965391|NCT00881647|EG001|Reported Event|Waitlist|Participants placed on a waitlist for 8 weeks.
10965392|NCT00881712|BG000|Baseline|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
10965393|NCT00881712|BG001|Baseline|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
10965394|NCT00881712|BG002|Baseline|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
10965395|NCT00881712|BG003|Baseline|Total|Total of all reporting groups
10965396|NCT00881712|FG000|Participant Flow|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
10965397|NCT00881712|FG001|Participant Flow|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
10965398|NCT00881712|FG002|Participant Flow|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
10965399|NCT00881712|OG000|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
10965400|NCT00881712|OG001|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
10965401|NCT00881712|OG002|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
10965402|NCT00881712|EG000|Reported Event|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
10965403|NCT00881712|EG001|Reported Event|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
10965404|NCT00881712|EG002|Reported Event|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
10965405|NCT00881751|BG000|Baseline|Arm I|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.~bevacizumab: Given IV~erlotinib hydrochloride: Given orally"
10965406|NCT00881751|BG001|Baseline|Arm II|"Patients receive oral sorafenib tosylate twice daily on days 1-28.~sorafenib tosylate: Given orally"
10965407|NCT00881751|BG002|Baseline|Total|Total of all reporting groups
10965408|NCT00881751|FG000|Participant Flow|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
10965409|NCT00881751|FG001|Participant Flow|Arm II|"Subjects who were enrolled to the sorafenib arm.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
10965410|NCT00881751|OG000|Outcome|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
10965411|NCT00881751|OG001|Outcome|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
10965412|NCT00881751|EG000|Reported Event|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
10965413|NCT00881751|EG001|Reported Event|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
10965414|NCT00881868|BG000|Baseline|Clobex Spray|
11194818|NCT02154347|OG000|Outcome|Placebo/KAD-1229|"Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.~KAD-1229~Placebo~Insulin"
10965415|NCT00881868|BG001|Baseline|Vehicle Spray|
10965416|NCT00881868|BG002|Baseline|Total|Total of all reporting groups
10965417|NCT00881868|FG000|Participant Flow|Clobex Spray|
10965418|NCT00881868|FG001|Participant Flow|Vehicle Spray|
10965419|NCT00881868|OG000|Outcome|Clobex Spray|
10965420|NCT00881868|OG001|Outcome|Vehicle Spray|
10965421|NCT00881868|EG000|Reported Event|Clobex Spray|
10965422|NCT00881868|EG001|Reported Event|Vehicle Spray|
10965423|NCT00881894|BG000|Baseline|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
10965424|NCT00881894|BG001|Baseline|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
10965425|NCT00881894|BG002|Baseline|Total|Total of all reporting groups
10965426|NCT00881894|FG000|Participant Flow|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
10965427|NCT00881894|FG001|Participant Flow|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
10965428|NCT00881894|OG000|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
10965429|NCT00881894|OG001|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
10965430|NCT00881894|EG000|Reported Event|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
10965431|NCT00881894|EG001|Reported Event|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
10965432|NCT00881959|BG000|Baseline|Group 1: Puros Dermis|"Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
10965433|NCT00881959|BG001|Baseline|Group 2: Alloderm|"Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
10965434|NCT00881959|BG002|Baseline|Total|Total of all reporting groups
10965435|NCT00881959|FG000|Participant Flow|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
10965436|NCT00881959|FG001|Participant Flow|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
10965437|NCT00881959|OG000|Outcome|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
10965438|NCT00881959|OG001|Outcome|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
10965439|NCT00881959|EG000|Reported Event|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
10965440|NCT00881959|EG001|Reported Event|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
10965441|NCT00882102|BG000|Baseline|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
10965442|NCT00882102|FG000|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
10965443|NCT00882102|OG000|Outcome|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
10965444|NCT00882102|EG000|Reported Event|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
10965445|NCT00882115|BG000|Baseline|DEP Challenge in Subjects Consuming BSE|DEP will be administered in nostrils of participants who receive BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
10965446|NCT00882115|FG000|Participant Flow|Cell Count Change in Response to Nasal DEP Challenge.|Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
10965447|NCT00882115|OG000|Outcome|Nasal DEP Challenge|All participants consumed 1.25 g BSE suspended in juice once a day for 4 consecutive days prior to dosing of 300 microg DEP in 200 microL saline
10965448|NCT00882115|EG000|Reported Event|Cell Count Change in Response to Nasal DEP Challenge|Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
10965449|NCT00882206|BG000|Baseline|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
10965450|NCT00882206|FG000|Participant Flow|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 - 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
10965451|NCT00882206|OG000|Outcome|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
10965452|NCT00882206|OG000|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 - 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
10965453|NCT00882206|EG000|Reported Event|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 - 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)"
10965454|NCT00882362|BG000|Baseline|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
10965455|NCT00882362|BG001|Baseline|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
10965456|NCT00882362|BG002|Baseline|Total|Total of all reporting groups
10965457|NCT00882362|FG000|Participant Flow|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
10965458|NCT00882362|FG001|Participant Flow|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
10965459|NCT00882362|OG000|Outcome|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
10965460|NCT00882362|OG001|Outcome|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
10965461|NCT00882362|EG000|Reported Event|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
10965462|NCT00882362|EG001|Reported Event|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
10965463|NCT00882518|BG000|Baseline|Seroquel_XR|Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics
10965464|NCT00882518|BG001|Baseline|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics
10965465|NCT00882518|BG002|Baseline|Total|Total of all reporting groups
10965466|NCT00882518|FG000|Participant Flow|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
10965467|NCT00882518|FG001|Participant Flow|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
10965468|NCT00882518|OG000|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
10965469|NCT00882518|OG001|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
10965470|NCT00882518|EG000|Reported Event|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
10965471|NCT00882518|EG001|Reported Event|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
10965472|NCT00882557|BG000|Baseline|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
10965473|NCT00882557|BG001|Baseline|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
10965474|NCT00882557|BG002|Baseline|Total|Total of all reporting groups
10965475|NCT00882557|FG000|Participant Flow|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
10965476|NCT00882557|FG001|Participant Flow|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
10965477|NCT00882557|OG000|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
10965478|NCT00882557|OG001|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
10965479|NCT00882557|EG000|Reported Event|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
10965480|NCT00882557|EG001|Reported Event|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
10965481|NCT00882583|BG000|Baseline|Cohort A|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
11194819|NCT02154347|OG001|Outcome|KAD-1229/KAD-1229|"Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.~KAD-1229~Insulin"
10850676|NCT00303979|OG000|Outcome|Cohort A (at Baseline)|For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes all the atients at baseline. Percentage of patients who were eligible for a performance measure that were treated by it at baseline was calculated.
10850677|NCT00303979|OG001|Outcome|Cohort A (at 24 Months)|For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes the completers, i.e. patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months. Percentage of the patients who were eligible for a performance measure that were treated by it at the 24 months was calculated.
10850678|NCT00303979|OG002|Outcome|Cohort A (Relative Change 24 Months vs. Baseline)|For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes the completers, i.e. patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months. The relative changes in the percentages from 24 months to baseline were calculated for the 7 performance measures.
10850679|NCT00303979|OG000|Outcome|Practice Sites in Cohort A|In this analysis, 167 practices contributed data to the baseline chart review of Cohort A. Of them, 12 practices withdrew from the study prior to the next chart review milestone. Therefore, 155 practices' data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop. Correspondingly there were 7605 patients whose chart review was completed at both baseline and 24 months.
10850680|NCT00303979|OG000|Outcome|Cohort A (at Baseline)|Cohort A at baseline included 15177 patients from 167 study sites (practices).
10850681|NCT00303979|OG001|Outcome|Cohort A (at 24 Months)|Cohort A at 24 months included 7605 patients from 155 study sites (practices).
10850682|NCT00303979|OG002|Outcome|Cohort A (Relative Change 24 Months vs. Baseline)|The ralative changes in performance measures and compsite score at 24 months compared to baseline were calculated based on 155 study sites that involved 7605 patients.
10850683|NCT00303979|OG000|Outcome|Cohort A: Baseline|In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.
10850684|NCT00303979|OG001|Outcome|Cohort B: 6 Months|In this analysis, data of Cohort B (i.e. 6 months single time point cohort) were used. This included 9992 patients from 154 cardiology practices.
10850685|NCT00303979|OG002|Outcome|Cohort B 6 Months vs. Cohort A Baseline (Relative Change)|The relative changes in performance measures and composite score of Cohort B (6 months) compared with those of Cohort A at baseline were calculated
10850686|NCT00303979|OG001|Outcome|Cohort C (18 Months)|In this analysis, data of Cohort C (i.e. 18 months single time point cohort) were used. This included 9641 patients from 150 cardiology practices.
10850687|NCT00303979|OG002|Outcome|Cohort C 18 Months vs. Cohort A Baseline (Relative Change)|The relative changes in performance measures and composite score of Cohort C (18 months) compared with those of Cohort A at baseline were calculated.
10850688|NCT00303979|EG000|Reported Event|Cohort A (Baseline, 12 and 24 Months)|Cohort A: The charts of 15,177 patients were reviewed at baseline, 12 months and 24 months. The principal investigator and HF nurse of the study sites attended an educational workshop at baseline, 12 and 24 months as well where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort A is a longitudinal cohort.
10850689|NCT00303979|EG001|Reported Event|Cohort B (6 Months)|Cohort B: The charts of 9,992 patients were reviewed at 6 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort B is a single time point cohort.
10850690|NCT00303979|EG002|Reported Event|Cohort C (18 Months)|Cohort C: The charts of 9,641 patients were reviewed at 18 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort C is a single time point cohort.
10850691|NCT00304031|BG000|Baseline|No Adjuvant TMZ (Not Randomized )|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
10850692|NCT00304031|BG001|Baseline|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
10850693|NCT00304031|BG002|Baseline|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
10850694|NCT00304031|BG003|Baseline|Total|Total of all reporting groups
10850695|NCT00304031|FG000|Participant Flow|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
10850696|NCT00304031|FG001|Participant Flow|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
10850697|NCT00304031|FG002|Participant Flow|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
10850698|NCT00304031|OG000|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
10850699|NCT00304031|OG001|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
10965482|NCT00882583|BG001|Baseline|Cohort B|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
10965483|NCT00882583|BG002|Baseline|Total|Total of all reporting groups
10965484|NCT00882583|FG000|Participant Flow|Cohort A T2N0, T1-2N1 SCCHN|"There will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
10965485|NCT00882583|FG001|Participant Flow|Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN|"There will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
10965486|NCT00882583|OG000|Outcome|Cohort A|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
10965487|NCT00882583|OG001|Outcome|Cohort B|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
10965488|NCT00882583|EG000|Reported Event|Cohort A|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
10965489|NCT00882583|EG001|Reported Event|Cohort B|"In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
10965490|NCT00882661|BG000|Baseline|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
10965491|NCT00882661|BG001|Baseline|ASSURE Cervical Plate and Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
10965492|NCT00882661|BG002|Baseline|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
10965493|NCT00882661|BG003|Baseline|Total|Total of all reporting groups
10965494|NCT00882661|FG000|Participant Flow|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
10965495|NCT00882661|FG001|Participant Flow|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
10965496|NCT00882661|OG000|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
10965497|NCT00882661|OG001|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
10965498|NCT00882661|OG002|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
10965499|NCT00882661|OG002|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
10965500|NCT00882661|EG000|Reported Event|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
10965501|NCT00882661|EG001|Reported Event|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
10965502|NCT00882687|BG000|Baseline|Lifitegrast 0.1%|
10965503|NCT00882687|BG001|Baseline|Lifitegrast 1.0%|
10965504|NCT00882687|BG002|Baseline|Lifitegrast 5.0%|
10965505|NCT00882687|BG003|Baseline|Placebo|
10965506|NCT00882687|BG004|Baseline|Total|Total of all reporting groups
10965507|NCT00882687|FG000|Participant Flow|Lifitegrast 0.1%|
10965508|NCT00882687|FG001|Participant Flow|Lifitegrast 1.0%|
10965509|NCT00882687|FG002|Participant Flow|Lifitegrast 5.0%|
10965510|NCT00882687|FG003|Participant Flow|Placebo|
10965511|NCT00882687|OG000|Outcome|Lifitegrast 0.1%|
10965512|NCT00882687|OG001|Outcome|Lifitegrast 1.0%|
10965513|NCT00882687|OG002|Outcome|Lifitegrast 5.0%|
10965514|NCT00882687|OG003|Outcome|Placebo|
10965515|NCT00882687|EG000|Reported Event|Lifitegrast 0.1%|
10965516|NCT00882687|EG001|Reported Event|Lifitegrast 1.0%|
10965517|NCT00882687|EG002|Reported Event|Lifitegrast 5.0%|
10965518|NCT00882687|EG003|Reported Event|Placebo|
10965519|NCT00882713|BG000|Baseline|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
10965520|NCT00882713|FG000|Participant Flow|C.E.R.A.|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
10965521|NCT00882713|OG000|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
10965522|NCT00882713|OG000|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
10965523|NCT00882713|EG000|Reported Event|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
10965524|NCT00882778|BG000|Baseline|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
10965525|NCT00882778|FG000|Participant Flow|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
10965526|NCT00882778|OG000|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
10965527|NCT00882778|EG000|Reported Event|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
10965528|NCT00882908|BG000|Baseline|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965529|NCT00882908|BG001|Baseline|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965530|NCT00882908|BG002|Baseline|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965531|NCT00882908|BG003|Baseline|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
11194820|NCT02154347|EG000|Reported Event|Placebo/KAD-1229 (Data Through Week 16)|Show the adverse events which occurred with placebo administration during the double-blind period
11194821|NCT02154347|EG001|Reported Event|KAD-1229/KAD-1229 (Data Through Week 16)|Show the adverse events which occurred with KAD-1229 administration during the double-blind period
11194822|NCT02154347|EG002|Reported Event|KAD-1229 (Data Through Week 52)|KDT-1229 administration period in all patients
11194823|NCT02154386|BG000|Baseline|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194824|NCT02154386|BG001|Baseline|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194825|NCT02154386|BG002|Baseline|Total|Total of all reporting groups
11194826|NCT02154386|FG000|Participant Flow|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
10850700|NCT00304031|OG000|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
10850701|NCT00304031|OG000|Outcome|Methylated|Methylated MGMT (O[6]-methylguanine-DNA methyltransferase)
10850702|NCT00304031|OG001|Outcome|Unmethylated|Unmethylated MGMT (O[6]-methylguanine-DNA methyltransferase)
10850703|NCT00304031|OG000|Outcome|No Progression at 6 Months|
10850704|NCT00304031|OG001|Outcome|Progression at 6 Months|
10850705|NCT00304031|OG000|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle for 6 cycles, up to 12 cycles.
10850706|NCT00304031|OG001|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle for 6 cycles, up to 12 cycles.
10850707|NCT00304031|OG000|Outcome|Both Arms Combined|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, either [100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle] or [75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle] for 6 cycles, up to 12 cycles.
10850708|NCT00304031|EG000|Reported Event|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
10850709|NCT00304031|EG001|Reported Event|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
10850710|NCT00304031|EG002|Reported Event|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
10850711|NCT00304083|BG000|Baseline|NF1 MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850712|NCT00304083|BG001|Baseline|Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850713|NCT00304083|BG002|Baseline|Total|Total of all reporting groups
10850714|NCT00304083|FG000|Participant Flow|NF1 MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850715|NCT00304083|FG001|Participant Flow|Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10803771|NCT02134028|EG002|Reported Event|Participants From EFC13579 Study Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803772|NCT02134028|EG003|Reported Event|Participants From EFC13579 Study Dupilumab/Dupilumab|Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803773|NCT02134028|EG004|Reported Event|Participants From EFC13691 Study Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803774|NCT02134028|EG005|Reported Event|Participants From EFC13691 Study Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803775|NCT02134028|EG006|Reported Event|Participants From PDY14192 Study Placebo/Dupilumab|Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with CS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803776|NCT02134028|EG007|Reported Event|Participants From PDY14192 Study Dupilumab/Dupilumab|Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
10803777|NCT02037620|BG000|Baseline|Epidural Stimulation|"80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.~5-6-5 Specify electrode~Restore Advance Pulse Generator"
10803778|NCT02037620|FG000|Participant Flow|Epidural Stimulation|"80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.~5-6-5 Specify electrode~Restore Advance Pulse Generator"
10803779|NCT02037620|OG000|Outcome|Epidural Stimulation|"80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.~5-6-5 Specify electrode~Restore Advance Pulse Generator"
10803780|NCT02037620|EG000|Reported Event|Epidural Stimulation|"80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.~5-6-5 Specify electrode~Restore Advance Pulse Generator~*Each participant received all of the interventions. Thus, adverse events cannot be reported for each independent intervention."
10849939|NCT00299182|OG003|Outcome|Arm B 1mcg/kg|Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2.
10849940|NCT00299182|OG004|Outcome|Arm B 3mcg/kg|Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2.
10849941|NCT00299182|OG005|Outcome|Arm B 10mcg/kg|Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2.
10849942|NCT00299182|OG006|Outcome|Placebo|Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2.
10849943|NCT00299182|OG001|Outcome|Arm A 3mcg/kg|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849944|NCT00299182|OG002|Outcome|Arm A 10mcg/kg|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10850747|NCT00304187|EG000|Reported Event|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
11382449|NCT01015833|FG001|Participant Flow|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11382450|NCT01015833|OG000|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
10803809|NCT01900444|BG000|Baseline|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
10803810|NCT01900444|FG000|Participant Flow|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
10803811|NCT01900444|OG000|Outcome|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
10803812|NCT01900444|EG000|Reported Event|Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
10803813|NCT01887912|BG000|Baseline|C. Difficile Vaccine Group|Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803814|NCT01887912|BG001|Baseline|Placebo Group|Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803815|NCT01887912|BG002|Baseline|Total|Total of all reporting groups
10803816|NCT01887912|FG000|Participant Flow|C. Difficile Vaccine Group|Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803817|NCT01887912|FG001|Participant Flow|Placebo Group|Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803818|NCT01887912|OG000|Outcome|C. Difficile Vaccine Group|Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803819|NCT01887912|OG001|Outcome|Placebo Group|Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803820|NCT01887912|EG000|Reported Event|C. Difficile Vaccine Group|Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803821|NCT01887912|EG001|Reported Event|Placebo Group|Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
10803822|NCT01751126|BG000|Baseline|High Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
10803823|NCT01751126|BG001|Baseline|Low Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
10803824|NCT01751126|BG002|Baseline|Placebo|1 drop of placebo 4 times a day as monotherapy.
10803825|NCT01751126|BG003|Baseline|Total|Total of all reporting groups
10803826|NCT01751126|FG000|Participant Flow|High Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
10803827|NCT01751126|FG001|Participant Flow|Low Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
10803828|NCT01751126|FG002|Participant Flow|Placebo|1 drop of placebo 4 times a day as monotherapy.
10803829|NCT01751126|OG000|Outcome|High Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
10803830|NCT01751126|OG001|Outcome|Low Dose Regimen|1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
10803831|NCT01751126|OG002|Outcome|Placebo|1 drop of placebo 4 times a day as monotherapy.
10803832|NCT01751126|OG000|Outcome|LogMAR - High Dose Regimen|Logarithm of the Minimum Angle of Resolution (LogMAR)
10803833|NCT01751126|OG001|Outcome|LogMAR - Low Dose Regimen|
10803834|NCT01751126|OG002|Outcome|LogMAR-Placebo|
10803835|NCT01751126|OG003|Outcome|Change From Baseline in LogMAR- High Dose|
10803836|NCT01751126|OG004|Outcome|Change From Baseline in LogMAR- Low Dose|
10803837|NCT01751126|OG005|Outcome|Change From Baseline in LogMAR- Placebo|
10803838|NCT01751126|OG000|Outcome|LogMAR - High Dose Regimen|
10803839|NCT01751126|OG001|Outcome|LogMAR - Placebo|
10803840|NCT01751126|OG002|Outcome|LogMAR-Total|
10803841|NCT01751126|OG004|Outcome|Change From Baseline in LogMAR- Placebo|
10803842|NCT01751126|OG005|Outcome|Change From Baseline in LogMAR- Total|
10803843|NCT01751126|EG000|Reported Event|.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)|Participants in this group received High dose in Period I (4 months) and continuing in High dose in the follow up period (8 months).
10803844|NCT01751126|EG001|Reported Event|Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)|Participants in this group received Placebo in Period I (4 months) and continuing in High dose in the follow up period (8 months).
10803845|NCT01751126|EG002|Reported Event|Total High Dose|Total of participants that received High dose from the overall study period (0-12 months).
10803846|NCT01751126|EG003|Reported Event|.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)|Participants in this group received Low dose in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
10803847|NCT01751126|EG004|Reported Event|Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)|Participants in this group received Placebo in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
10803848|NCT01751126|EG005|Reported Event|Total Low Dose|Total of participants that received High dose from the overall study period (0-12 months).
10850748|NCT00304187|EG001|Reported Event|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
10965532|NCT00882908|BG004|Baseline|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
10965533|NCT00882908|BG005|Baseline|Total|Total of all reporting groups
10965534|NCT00882908|FG000|Participant Flow|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965535|NCT00882908|FG001|Participant Flow|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965536|NCT00882908|FG002|Participant Flow|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965537|NCT00882908|FG003|Participant Flow|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965538|NCT00882908|FG004|Participant Flow|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
10965539|NCT00882908|OG000|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965540|NCT00882908|OG001|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965541|NCT00882908|OG002|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965542|NCT00882908|OG003|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
11194827|NCT02154386|FG001|Participant Flow|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
10965543|NCT00882908|OG004|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
10965544|NCT00882908|OG004|Outcome|All TMC435 Treatment Groups|Participants in all 4 TMC435 treatment groups combined.
10965545|NCT00882908|EG000|Reported Event|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965546|NCT00882908|EG001|Reported Event|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
11382451|NCT01015833|OG001|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10965547|NCT00882908|EG002|Reported Event|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965548|NCT00882908|EG003|Reported Event|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
10965549|NCT00882908|EG004|Reported Event|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
10965550|NCT00882921|BG000|Baseline|Elaprase® (0.5 mg/kg)|
10965551|NCT00882921|FG000|Participant Flow|Elaprase® (0.5 mg/kg)|
10965552|NCT00882921|OG000|Outcome|Idursulfase (Elaprase) 0.5 mg/kg Weekly|Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
10965553|NCT00882921|OG000|Outcome|Elaprase|Idursulfase 0.5 mg/kg Weekly Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
10965554|NCT00882921|EG000|Reported Event|Elaprase® (0.5 mg/kg)|
10965555|NCT00882999|BG000|Baseline|4 mg LY2127399 Q4W|LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
10965556|NCT00882999|BG001|Baseline|12 mg LY2127399 Q4W|LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
10965557|NCT00882999|BG002|Baseline|40 mg LY2127399 Q4W|LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
10965558|NCT00882999|BG003|Baseline|120 mg LY2127399 Q4W|LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
10965559|NCT00882999|BG004|Baseline|4 mg LY2127399 Q12W|"LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12)."
10965560|NCT00882999|BG005|Baseline|120 mg LY2127399 Q12W|"LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12)."
10965561|NCT00882999|BG006|Baseline|Placebo|Placebo: Subcutaneous injection Q4W for 24 weeks.
10965562|NCT00882999|BG007|Baseline|Total|Total of all reporting groups
10965563|NCT00882999|FG000|Participant Flow|4 mg LY2127399 Q4W|LY2127399: 4 milligrams (mg) subcutaneous injection once every 4 weeks (Q4W) for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
10965564|NCT00882999|FG001|Participant Flow|12 mg LY2127399 Q4W|LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
10965565|NCT00882999|FG002|Participant Flow|40 mg LY2127399 Q4W|LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
10965566|NCT00882999|FG003|Participant Flow|120 mg LY2127399 Q4W|LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
10965567|NCT00882999|FG004|Participant Flow|4 mg LY2127399 Q12W|"LY2127399: 4 mg subcutaneous injection every 12 weeks (Q12W) for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12)."
10965568|NCT00882999|FG005|Participant Flow|120 mg LY2127399 Q12W|"LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12)."
10965569|NCT00882999|FG006|Participant Flow|Placebo|Placebo: Subcutaneous injection Q4W for 24 weeks.
10965570|NCT00882999|OG000|Outcome|4 mg LY2127399 Q4W|LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
10965571|NCT00882999|OG001|Outcome|12 mg LY2127399 Q4W|LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
10965572|NCT00882999|OG002|Outcome|40 mg LY2127399 Q4W|LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
10965573|NCT00882999|OG003|Outcome|120 mg LY2127399 Q4W|LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
11382452|NCT01015833|EG000|Reported Event|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
11382453|NCT01015833|EG001|Reported Event|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10965574|NCT00882999|OG004|Outcome|4 mg LY2127399 Q12W|"LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12)."
10965575|NCT00882999|OG005|Outcome|120 mg LY2127399 Q12W|"LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12)."
10965576|NCT00882999|OG006|Outcome|Placebo|Placebo: Subcutaneous injection Q4W for 24 weeks.
10965577|NCT00882999|EG000|Reported Event|4 mg LY2127399 Q4W, Treatment|"Adverse Events (AEs) reported during study treatment (up to Week 24).~LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20)."
10965578|NCT00882999|EG001|Reported Event|12 mg LY2127399 Q4W, Treatment|"AEs reported during study treatment (up to Week 24).~LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks."
10965579|NCT00882999|EG002|Reported Event|40 mg LY2127399 Q4W, Treatment|"AEs reported during study treatment (up to Week 24).~LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks."
10965580|NCT00882999|EG003|Reported Event|120 mg LY2127399 Q4W, Treatment|"AEs reported during study treatment (up to Week 24).~LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks."
10965581|NCT00882999|EG004|Reported Event|4 mg LY2127399 Q12W, Treatment|"AEs reported during study treatment (up to Week 24).~LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12)."
10965582|NCT00882999|EG005|Reported Event|120 mg LY2127399 Q12W, Treatment|"AEs reported during study treatment (up to Week 24).~LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).~Placebo: Subcutaneous injection every Q4W for 24 weeks (except Weeks 0 and 12)."
10965583|NCT00882999|EG006|Reported Event|Placebo, Treatment|"AEs reported during study treatment (up to Week 24).~Placebo: Subcutaneous injection Q4W for 24 weeks."
10965584|NCT00882999|EG007|Reported Event|4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q4W for 24 weeks.~No study drug was administered during the post-study treatment follow-up."
10965585|NCT00882999|EG008|Reported Event|12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 12 mg LY2127399 subcutaneous injection Q4W for 24 weeks.~No study drug was administered during the post-study treatment follow-up."
10965586|NCT00882999|EG009|Reported Event|40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 40 mg LY2127399 subcutaneous injection Q4W for 24 weeks.~No study drug was administered during the post-study treatment follow-up."
10965587|NCT00882999|EG010|Reported Event|120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 120 mg LY2127399 subcutaneous injection Q4W for 24 weeks.~No study drug was administered during the post-study treatment follow-up."
10965588|NCT00882999|EG011|Reported Event|4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).~No study drug was administered during the post-study treatment follow-up."
11194828|NCT02154386|OG000|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194829|NCT02154386|OG001|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194830|NCT02154386|EG000|Reported Event|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194831|NCT02154386|EG001|Reported Event|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
11194832|NCT02154425|BG000|Baseline|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
11194833|NCT02154425|FG000|Participant Flow|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
11194834|NCT02154425|OG000|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
11194835|NCT02154425|OG001|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
11194836|NCT02154425|OG000|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
11194837|NCT02154425|OG000|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
11194838|NCT02154425|EG000|Reported Event|SS-M|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
10803859|NCT01437423|BG000|Baseline|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
10803860|NCT01437423|FG000|Participant Flow|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
10803861|NCT01437423|OG000|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
10803862|NCT01437423|EG000|Reported Event|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
10803863|NCT01410890|BG000|Baseline|Alglucosidase Alfa: <18 Years|Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10803864|NCT01410890|BG001|Baseline|Alglucosidase Alfa: >=18 Years|Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10803865|NCT01410890|BG002|Baseline|Total|Total of all reporting groups
10803866|NCT01410890|FG000|Participant Flow|Alglucosidase Alfa: <18 Years|Participants with less than (<) 18 years of age received intravenous (IV) infusion of Alglucosidase alfa 20 milligram per kilogram (mg/kg) body weight on Day 1. Infusion was administered at an initial rate of approximately 1 milligrams per kilogram per hour (mg/kg/hr) with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of infusion-associated reactions (IARs), until a maximum rate of approximately 7 mg/kg/hr was reached.
10803867|NCT01410890|FG001|Participant Flow|Alglucosidase Alfa: >=18 Years|Participants with greater than or equal to (>=) 18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10803868|NCT01410890|OG000|Outcome|Alglucosidase Alfa: <18 Years|Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10965589|NCT00882999|EG012|Reported Event|120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a120 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).~No study drug was administered during the post-study treatment follow-up."
11194839|NCT02154425|EG001|Reported Event|SS-I|This arm consisted of all infants of mothers in the SS-M.
11194840|NCT02154477|BG000|Baseline|Diabetes|"All patients will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit~intranasal insulin~placebo (intranasal saline)"
11194841|NCT02154477|BG001|Baseline|Control|"All control subjects will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit~intranasal insulin~placebo (intranasal saline)"
11194842|NCT02154477|BG002|Baseline|Total|Total of all reporting groups
11194843|NCT02154477|FG000|Participant Flow|Control|lean healthy men, randomized to receive saline or insulin at first visit and the alternate treatment at second visit
11194844|NCT02154477|FG001|Participant Flow|Diabetes|men with diabetes, randomized to receive saline or insulin at first visit and the alternate treatment at second visit
11194845|NCT02154477|OG000|Outcome|Diabetes|"All patient will receive insulin at one visit and saline at another visit~intranasal insulin~placebo (intranasal saline)"
11194846|NCT02154477|OG001|Outcome|Control|lean healthy men. All men will receive insulin at one visit and saline at the other.
11194847|NCT02154477|EG000|Reported Event|Diabetes|"All diabetes patients were randomized to receive either insulin or saline at one visit and the alternate treatment at the second visit.~intranasal insulin~placebo (intranasal saline)"
10802265|NCT02227862|OG001|Outcome|Lantus®|"Receive Lantus® plus insulin lispro~Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802266|NCT02227862|EG000|Reported Event|Mylan's Insulin Glargine|"Receive Mylan's Insulin Glargine plus insulin lispro.~Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802267|NCT02227862|EG001|Reported Event|Lantus®|"Receive Lantus® plus insulin lispro~Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum."
10802268|NCT02200939|BG000|Baseline|Partial-Thickness Tear|Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802269|NCT02200939|BG001|Baseline|Full Thickness Tear|"Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.~Surgical repair: Surgical repair with commercially-available sutures/suture anchors."
10802270|NCT02200939|BG002|Baseline|Total|Total of all reporting groups
10802271|NCT02200939|FG000|Participant Flow|Partial-Thickness Tear|Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802272|NCT02200939|FG001|Participant Flow|Full Thickness Tear|"Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.~Surgical repair: Surgical repair with commercially-available sutures/suture anchors."
10802273|NCT02200939|OG000|Outcome|Intermediate Partial-Thickness Tear|Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802274|NCT02200939|OG001|Outcome|High Partial-Thickness Tear|High partial-thickness tear (> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802275|NCT02200939|OG002|Outcome|Medium Full Thickness Tear|Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802276|NCT02200939|OG003|Outcome|Large Full Thickness Tear|Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802277|NCT02200939|OG000|Outcome|Partial-Thickness Tear|Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802278|NCT02200939|OG001|Outcome|Full Thickness Tear|"Medium or large full-thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.~Surgical repair: Surgical repair with commercially-available sutures/suture anchors."
10802279|NCT02200939|EG000|Reported Event|Partial-Thickness Tear|Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
10802280|NCT02200939|EG001|Reported Event|Full Thickness Tear|"Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.~Surgical repair: Surgical repair with commercially-available sutures/suture anchors."
10802281|NCT02108964|BG000|Baseline|EGF816 75 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
11194848|NCT02154477|EG001|Reported Event|Control|"All control subjects were randomized to receive either insulin or saline at one visit and the alternate treatment at the second visit.~intranasal insulin~placebo (intranasal saline)"
11194849|NCT02154581|BG000|Baseline|Type 1 Implant and Thick Biotype|"In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.~SLActive implant"
11194850|NCT02154581|BG001|Baseline|Type 1 Implant and Thin Biotype|"In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.~SLActive implant"
11194851|NCT02154581|BG002|Baseline|Total|Total of all reporting groups
10802282|NCT02108964|BG001|Baseline|EGF816 100 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802283|NCT02108964|BG002|Baseline|EGF816 150 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802284|NCT02108964|BG003|Baseline|EGF816 200 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802285|NCT02108964|BG004|Baseline|EGF816 225 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802286|NCT02108964|BG005|Baseline|EGF816 300 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802287|NCT02108964|BG006|Baseline|EGF816 350 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802288|NCT02108964|BG007|Baseline|EGF816 150 mg (Phase II Part)|Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
10802289|NCT02108964|BG008|Baseline|Total|Total of all reporting groups
10802290|NCT02108964|FG000|Participant Flow|EGF816 75 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802291|NCT02108964|FG001|Participant Flow|EGF816 100 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802292|NCT02108964|FG002|Participant Flow|EGF816 150 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802293|NCT02108964|FG003|Participant Flow|EGF816 200 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802294|NCT02108964|FG004|Participant Flow|EGF816 225 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802295|NCT02108964|FG005|Participant Flow|EGF816 300 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802296|NCT02108964|FG006|Participant Flow|EGF816 350 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802297|NCT02108964|FG007|Participant Flow|EGF816 150 mg (Phase II Part)|Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
10802298|NCT02108964|OG000|Outcome|EGF816 75 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802299|NCT02108964|OG001|Outcome|EGF816 100 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802300|NCT02108964|OG002|Outcome|EGF816 150 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802301|NCT02108964|OG003|Outcome|EGF816 200 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802302|NCT02108964|OG004|Outcome|EGF816 225 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802303|NCT02108964|OG005|Outcome|EGF816 300 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
11194852|NCT02154581|FG000|Participant Flow|Type 1 Implant and Thick Biotype|"In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.~SLActive implant"
11382454|NCT00937937|BG000|Baseline|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11382455|NCT00937937|FG000|Participant Flow|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11382456|NCT00937937|OG000|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11382457|NCT00937937|OG000|Outcome|Dinaciclib|
11382458|NCT00937937|EG000|Reported Event|SCH 727965|
11382459|NCT00843882|BG000|Baseline|Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)|Patients receive lenalidomide PO QD on days 1-21.
11382460|NCT00843882|BG001|Baseline|Arm A (Lenalidomide; Randomization)|Patients receive lenalidomide PO QD on days 1-21.
11382461|NCT00843882|BG002|Baseline|Arm B (Lenalidomide + Epoetin Alfa; Randomization)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382462|NCT00843882|BG003|Baseline|Total|Total of all reporting groups
11382463|NCT00843882|FG000|Participant Flow|Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)|Patients receive lenalidomide PO QD on days 1-21.
11382464|NCT00843882|FG001|Participant Flow|Arm A (Lenalidomide; Randomization)|Patients receive lenalidomide PO QD on days 1-21.
11382465|NCT00843882|FG002|Participant Flow|Arm B (Lenalidomide + Epoetin Alfa; Randomization)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382466|NCT00843882|OG000|Outcome|Arm A (Lenalidomide; Randomization)|Patients receive lenalidomide PO QD on days 1-21.
11382467|NCT00843882|OG001|Outcome|Arm B (Lenalidomide + Epoetin Alfa; Randomization)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382468|NCT00843882|OG000|Outcome|Arm B (Lenalidomide + Epoetin Alfa; Crossover)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382469|NCT00843882|OG000|Outcome|Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)|Patients receive lenalidomide PO QD on days 1-21.
11382470|NCT00843882|OG000|Outcome|Major Erythroid Response|Patients with major erythroid response
11382471|NCT00843882|OG001|Outcome|No Major Erythroid Response|Patients without major erythroid response
11382472|NCT00843882|OG000|Outcome|Arm A Patients With Major Erythroid Response|Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
11382473|NCT00843882|OG001|Outcome|Arm A Patients Without Major Erythroid Response|Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
11382474|NCT00843882|EG000|Reported Event|Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)|Patients receive lenalidomide PO QD on days 1-21.
11382475|NCT00843882|EG001|Reported Event|Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382476|NCT00843882|EG002|Reported Event|Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)|Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
11382477|NCT00792948|BG000|Baseline|Treatment|
11382478|NCT00792948|FG000|Participant Flow|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
11382479|NCT00792948|OG000|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
11382480|NCT00792948|EG000|Reported Event|Induction/Consolidation|Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.
11382481|NCT00792948|EG001|Reported Event|Vincristine/Prednisone/Dasatinib|Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.
11382482|NCT00792948|EG002|Reported Event|Allogeneic Stem Cell Transplant|Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.
11382483|NCT00792948|EG003|Reported Event|Dasatinib|Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
11382484|NCT00770809|BG000|Baseline|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382485|NCT00770809|BG001|Baseline|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382486|NCT00770809|BG002|Baseline|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
11382487|NCT00770809|BG003|Baseline|Total|Total of all reporting groups
11382488|NCT00770809|FG000|Participant Flow|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
10965590|NCT00882999|EG013|Reported Event|Placebo, Post-Study Treatment Follow-Up|"AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a placebo subcutaneous injection Q4W for 24 weeks.~No study drug was administered during the post-study treatment follow-up."
10965591|NCT00883051|BG000|Baseline|50 mg Lasmiditan|50 mg lasmiditan administered PO within 4 hours of a migraine attack
10802304|NCT02108964|OG006|Outcome|EGF816 350 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802305|NCT02108964|OG000|Outcome|EGF816 150 mg (Phase II Part)|Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
10802306|NCT02108964|EG000|Reported Event|EGF816 75 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
11194853|NCT02154581|FG001|Participant Flow|Type 1 Implant and Thin Biotype|"In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.~SLActive implant"
11194854|NCT02154581|OG000|Outcome|Type 1 Implant and Thick Biotype|"In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.~SLActive implant"
11194855|NCT02154581|OG001|Outcome|Type 1 Implant and Thin Biotype|"In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.~SLActive implant"
11194856|NCT02154581|OG000|Outcome|Type 1 Implant and Thick Biotype|"In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.~SLActive implant"
11194857|NCT02154581|OG001|Outcome|Type 1 Implant and Thin Biotype|"In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.~SLActive implant"
10802307|NCT02108964|EG001|Reported Event|EGF816 100 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10965592|NCT00883051|BG001|Baseline|100 mg Lasmiditan|100 mg lasmiditan administered PO within 4 hours of a migraine attack
11194858|NCT02154581|EG000|Reported Event|Type 1 Implant and Thick Biotype|"In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.~SLActive implant"
10802308|NCT02108964|EG002|Reported Event|EGF816 150 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802309|NCT02108964|EG003|Reported Event|EGF816 200 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802310|NCT02108964|EG004|Reported Event|EGF816 225 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802311|NCT02108964|EG005|Reported Event|EGF816 300 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802312|NCT02108964|EG006|Reported Event|EGF816 350 mg (Phase I Part)|Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
10802313|NCT02108964|EG007|Reported Event|EGF816 150 mg (Phase II Part)|Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
10802314|NCT02108964|EG008|Reported Event|All Subjects|All subjects
11194859|NCT02154581|EG001|Reported Event|Type 1 Implant and Thin Biotype|"In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.~SLActive implant"
11194860|NCT02154672|BG000|Baseline|BRCA2 Carriers|All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing
11194861|NCT02154672|FG000|Participant Flow|BRCA2 Carriers|All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing
11194862|NCT02154672|OG000|Outcome|BRCA2 Carriers|All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing
11382489|NCT00770809|FG001|Participant Flow|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382490|NCT00770809|FG002|Participant Flow|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
11382491|NCT00770809|OG000|Outcome|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382492|NCT00770809|OG001|Outcome|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382493|NCT00770809|OG002|Outcome|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
11382494|NCT00770809|EG000|Reported Event|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382495|NCT00770809|EG001|Reported Event|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
11382496|NCT00770809|EG002|Reported Event|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
11382497|NCT00769379|BG000|Baseline|Standard WBI|Standard WBI (Radiation Therapy)
11382498|NCT00769379|BG001|Baseline|WBI, Trastuzumab|WBI, trastuzumab (Radiation Therapy + Trastuzumab x 2 doses. Dose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV-given 3 weeks after dose 1
11382499|NCT00769379|BG002|Baseline|Total|Total of all reporting groups
11382500|NCT00769379|FG000|Participant Flow|Arm I (Standard WBI)|"Patients undergo standard WBI over 5-6 weeks.~Laboratory Biomarker Analysis: Correlative studies~Whole Breast Irradiation: Undergo standard whole breast irradiation"
11382501|NCT00769379|FG001|Participant Flow|Arm II (WBI, Trastuzumab)|"Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Trastuzumab: Given IV~Whole Breast Irradiation: Undergo standard whole breast irradiation"
11382502|NCT00769379|OG000|Outcome|Arm I (Standard WBI)|"Patients undergo standard WBI over 5-6 weeks.~Laboratory Biomarker Analysis: Correlative studies~Whole Breast Irradiation: Undergo standard whole breast irradiation"
11382503|NCT00769379|OG001|Outcome|Arm II (WBI, Trastuzumab)|"Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.~Laboratory Biomarker Analysis: Correlative studies~Trastuzumab: Given IV~Whole Breast Irradiation: Undergo standard whole breast irradiation"
11382504|NCT00769379|EG000|Reported Event|Standard WBI|standard WBI
11382505|NCT00769379|EG001|Reported Event|WBI, Trastuzumab|WBI, trastuzumab
11382506|NCT00731731|BG000|Baseline|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.>~dimensional conformal radiation therapy: Undergo radiotherapy> > temozolomide: Given PO> > vorinostat: Given PO> > cognitive assessment: Ancillary studies> > laboratory biomarker analysis: Correlative studies"
11382507|NCT00731731|BG001|Baseline|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.>~dimensional conformal radiation therapy: Undergo radiotherapy> > temozolomide: Given PO> > vorinostat: Given PO> > cognitive assessment: Ancillary studies> > laboratory biomarker analysis: Correlative studies"
11382508|NCT00731731|BG002|Baseline|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.>~dimensional conformal radiation therapy: Undergo radiotherapy> > temozolomide: Given PO> > vorinostat: Given PO> > cognitive assessment: Ancillary studies> > laboratory biomarker analysis: Correlative studies"
11382509|NCT00731731|BG003|Baseline|Total|Total of all reporting groups
11382510|NCT00731731|FG000|Participant Flow|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
10803869|NCT01410890|OG001|Outcome|Alglucosidase Alfa: >=18 Years|Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
11194863|NCT02154672|EG000|Reported Event|BRCA2 Carriers|All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing
11194864|NCT02154763|BG000|Baseline|Intraperitoneal Normal Saline|Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
11382511|NCT00731731|FG001|Participant Flow|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382512|NCT00731731|FG002|Participant Flow|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382513|NCT00731731|OG000|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382514|NCT00731731|OG001|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382515|NCT00731731|OG000|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382516|NCT00731731|OG002|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
11382517|NCT00731731|OG000|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
11382518|NCT00731731|OG000|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
11194865|NCT02154763|BG001|Baseline|Intraperitoneal Ropivacaine|200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
11194866|NCT02154763|BG002|Baseline|Total|Total of all reporting groups
11194867|NCT02154763|FG000|Participant Flow|Intraperitoneal Normal Saline|Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
10965593|NCT00883051|BG002|Baseline|200 mg Lasmiditan|200 mg lasmiditan administered PO within 4 hours of a migraine attack
10965594|NCT00883051|BG003|Baseline|400 mg Lasmiditan|400 mg lasmiditan administered PO within 4 hours of a migraine attack
10965595|NCT00883051|BG004|Baseline|Placebo|Placebo administered PO within 4 hours of a migraine attack
10965596|NCT00883051|BG005|Baseline|Total|Total of all reporting groups
10965597|NCT00883051|FG000|Participant Flow|50 mg Lasmiditan|50 mg lasmiditan administered PO within 4 hours of a migraine attack
10965598|NCT00883051|FG001|Participant Flow|100 mg Lasmiditan|100 mg lasmiditan administered PO within 4 hours of a migraine attack
10965599|NCT00883051|FG002|Participant Flow|200 mg Lasmiditan|200 mg lasmiditan administered PO within 4 hours of a migraine attack
10965600|NCT00883051|FG003|Participant Flow|400 mg Lasmiditan|400 mg lasmiditan administered PO within 4 hours of a migraine attack
10965601|NCT00883051|FG004|Participant Flow|Placebo|Placebo administered PO within 4 hours of a migraine attack
10965602|NCT00883051|OG000|Outcome|50 mg Lasmiditan|50 mg lasmiditan administered orally (PO)
10965603|NCT00883051|OG001|Outcome|100 mg Lasmiditan|100 mg lasmiditan administered orally (PO)
11194868|NCT02154763|FG001|Participant Flow|Intraperitoneal Ropivacaine|200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
11194869|NCT02154763|OG000|Outcome|Intraperitoneal Normal Saline|Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
11194870|NCT02154763|OG001|Outcome|Intraperitoneal Ropivacaine|200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
11194871|NCT02154763|OG000|Outcome|Intraperitoneal Normal Saline|"Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm~Normal Saline"
10965604|NCT00883051|OG002|Outcome|200 mg Lasmiditan|200 mg lasmiditan administered orally (PO)
10965605|NCT00883051|OG003|Outcome|400 mg Lasmiditan|400 mg lasmiditan administered orally (PO)
10965606|NCT00883051|OG004|Outcome|Placebo|Placebo administered orally (PO)
10965607|NCT00883051|EG000|Reported Event|50 mg Lasmiditan|50 mg lasmiditan administered orally (PO)
10965608|NCT00883051|EG001|Reported Event|100 mg Lasmiditan|100 mg lasmiditan administered orally (PO)
10965609|NCT00883051|EG002|Reported Event|200 mg Lasmiditan|200 mg lasmiditan administered orally (PO)
10965610|NCT00883051|EG003|Reported Event|400 mg Lasmiditan|400 mg lasmiditan administered orally (PO)
10965611|NCT00883051|EG004|Reported Event|Placebo|Placebo administered orally (PO)
10965612|NCT00883090|BG000|Baseline|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
10965613|NCT00883090|FG000|Participant Flow|FXIII|All subjects treated with Factor XIII Concentrate (Human) (FXIII)
10965614|NCT00883090|OG000|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
10965615|NCT00883090|EG000|Reported Event|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
10965616|NCT00883103|BG000|Baseline|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965617|NCT00883103|BG001|Baseline|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965618|NCT00883103|BG002|Baseline|Total|Total of all reporting groups
10965619|NCT00883103|FG000|Participant Flow|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965620|NCT00883103|FG001|Participant Flow|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965621|NCT00883103|OG000|Outcome|Lidocaine|Lidocaine gel was applied to the Q-tip and the catheter before insertion.
10965622|NCT00883103|OG001|Outcome|Aqueous Gel|Aqueous gel was applied to the Q-tip and the catheter before insertion.
10965623|NCT00883103|EG000|Reported Event|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965624|NCT00883103|EG001|Reported Event|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
10965625|NCT00883116|BG000|Baseline|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
10965626|NCT00883116|BG001|Baseline|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
10965627|NCT00883116|BG002|Baseline|Total|Total of all reporting groups
10965628|NCT00883116|FG000|Participant Flow|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
10965629|NCT00883116|FG001|Participant Flow|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
10965630|NCT00883116|OG000|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
10965631|NCT00883116|OG001|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
10965632|NCT00883116|OG001|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
10965633|NCT00883116|EG000|Reported Event|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
10965634|NCT00883116|EG001|Reported Event|Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)|Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
10965635|NCT00883116|EG002|Reported Event|Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)|Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.
10965636|NCT00883129|BG000|Baseline|Mycophenolate Arm|"Participants will receive oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
10965637|NCT00883129|BG001|Baseline|Cyclophosphamide Arm|"Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
10965638|NCT00883129|BG002|Baseline|Total|Total of all reporting groups
10965639|NCT00883129|FG000|Participant Flow|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
10965640|NCT00883129|FG001|Participant Flow|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
10965641|NCT00883129|OG000|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
10965642|NCT00883129|OG001|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
10965643|NCT00883129|EG000|Reported Event|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
10965644|NCT00883129|EG001|Reported Event|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
10965645|NCT00883168|BG000|Baseline|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
10965646|NCT00883168|BG001|Baseline|Azelastine Hcl|azelastine HCl nasal spray
10965647|NCT00883168|BG002|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
10965648|NCT00883168|BG003|Baseline|Placebo|placebo nasal spray
10965649|NCT00883168|BG004|Baseline|Total|Total of all reporting groups
10965650|NCT00883168|FG000|Participant Flow|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
10965651|NCT00883168|FG001|Participant Flow|Azelastine Hcl|azelastine HCl nasal spray
10965652|NCT00883168|FG002|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
10965653|NCT00883168|FG003|Participant Flow|Placebo|placebo nasal spray
10965654|NCT00883168|OG000|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
10965655|NCT00883168|OG001|Outcome|Azelastine Hcl|azelastine HCl nasal spray
10965656|NCT00883168|OG002|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
10965657|NCT00883168|OG003|Outcome|Placebo|placebo nasal spray
10965658|NCT00883168|EG000|Reported Event|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
10965659|NCT00883168|EG001|Reported Event|Azelastine Hcl|azelastine HCl nasal spray
10965660|NCT00883168|EG002|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
10965661|NCT00883168|EG003|Reported Event|Placebo|placebo nasal spray
10965662|NCT00883181|BG000|Baseline|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
10965663|NCT00883181|FG000|Participant Flow|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
10965664|NCT00883181|OG000|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
10965665|NCT00883181|OG001|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
10965666|NCT00883181|OG002|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
10965667|NCT00883181|OG003|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
10965668|NCT00883181|OG004|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
10965669|NCT00883181|OG005|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
10965670|NCT00883181|OG000|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
10965671|NCT00883181|OG000|Outcome|Any ESA Use|Participants who received treatment with any erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
11241072|NCT02484690|OG003|Outcome|Arm D: Faricimab, 6 mg Every 4-8 Weeks|Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
11241073|NCT02484690|OG001|Outcome|Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W|Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
11241074|NCT02484690|OG004|Outcome|Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W|Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
11241075|NCT02484690|EG000|Reported Event|Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)|Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
11241076|NCT02484690|EG001|Reported Event|Arm B: Faricimab, 1.5 mg Q4W|Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
11241077|NCT02484690|EG002|Reported Event|Arm C: Faricimab, 6 mg Q4W|Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
11241078|NCT02484690|EG003|Reported Event|Arm D: Faricimab, 6 mg Every 4-8 Weeks|Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
11241079|NCT02484690|EG004|Reported Event|Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W|Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
11241080|NCT02484729|BG000|Baseline|Part A- Placebo|Subjects received matching placebo under fasted conditions
11241081|NCT02484729|BG001|Baseline|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
10965672|NCT00883181|OG001|Outcome|No ESA Use|Participants who did not receive treatment with a erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
11241082|NCT02484729|BG002|Baseline|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11241083|NCT02484729|BG003|Baseline|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11241084|NCT02484729|BG004|Baseline|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11241085|NCT02484729|BG005|Baseline|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11241086|NCT02484729|BG006|Baseline|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11241087|NCT02484729|BG007|Baseline|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11241088|NCT02484729|BG008|Baseline|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11241089|NCT02484729|BG009|Baseline|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11241090|NCT02484729|BG010|Baseline|Total|Total of all reporting groups
11241091|NCT02484729|FG000|Participant Flow|Part A- Placebo|Subjects received matching placebo under fasted conditions
11241092|NCT02484729|FG001|Participant Flow|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
10965673|NCT00883181|EG000|Reported Event|Ovarian|Ovarian Cancer
11241093|NCT02484729|FG002|Participant Flow|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11241094|NCT02484729|FG003|Participant Flow|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11241095|NCT02484729|FG004|Participant Flow|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11241096|NCT02484729|FG005|Participant Flow|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11241097|NCT02484729|FG006|Participant Flow|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11241098|NCT02484729|FG007|Participant Flow|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11241099|NCT02484729|FG008|Participant Flow|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11241100|NCT02484729|FG009|Participant Flow|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11241101|NCT02484729|OG000|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11241102|NCT02484729|OG001|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11241103|NCT02484729|OG002|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11241104|NCT02484729|OG003|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11241105|NCT02484729|OG004|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11241106|NCT02484729|OG005|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11241107|NCT02484729|OG006|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11241108|NCT02484729|OG007|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11382519|NCT00731731|OG001|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
11382520|NCT00731731|OG002|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
11382521|NCT00731731|EG000|Reported Event|Phase I, Dose Level 0|laboratory biomarker analysis: Correlative studies
11382522|NCT00731731|EG001|Reported Event|Phase I, Dose Level 1|laboratory biomarker analysis: Correlative studies
11382523|NCT00731731|EG002|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
11382524|NCT00700882|BG000|Baseline|Dasatinib|Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11382525|NCT00700882|FG000|Participant Flow|Dasatinib|Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11382526|NCT00700882|OG000|Outcome|Dasatinib|Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11382527|NCT00700882|EG000|Reported Event|Dasatinib|Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10965674|NCT00883181|EG001|Reported Event|NSCLC|Non-small Cell Lung Cancer
11382528|NCT00658814|BG000|Baseline|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
11382529|NCT00658814|BG001|Baseline|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
11382530|NCT00658814|BG002|Baseline|Total|Total of all reporting groups
11382531|NCT00658814|FG000|Participant Flow|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
11382532|NCT00658814|FG001|Participant Flow|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
11382533|NCT00658814|OG000|Outcome|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
11382534|NCT00658814|OG001|Outcome|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
11382535|NCT00658814|OG002|Outcome|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
11382536|NCT00658814|OG000|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
10965675|NCT00883181|EG002|Reported Event|SCLC|Small Cell Lung Cancer
10965676|NCT00883181|EG003|Reported Event|Breast Stage I-III|Breast Cancer, Stages I-III
10965677|NCT00883181|EG004|Reported Event|Breast Metastatic|Breast Cancer, Metastatic
10965678|NCT00883181|EG005|Reported Event|Breast Total|All Breast Cancer
11241109|NCT02484729|OG008|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
10802315|NCT02022566|BG000|Baseline|Supported Self-management of Osteoarthrits Program|"Treatment with an supported self-management program for osteoarthritis.~A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks."
10802316|NCT02022566|BG001|Baseline|Control Group|No intervention
10802317|NCT02022566|BG002|Baseline|Total|Total of all reporting groups
10802318|NCT02022566|FG000|Participant Flow|Supported Self-management of Osteoarthrits Program|"Treatment with an supported self-management program for osteoarthritis.~A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks."
10802319|NCT02022566|FG001|Participant Flow|Control Group|No intervention
10802320|NCT02022566|OG000|Outcome|Supported Self-management of Osteoarthrits Program|"Treatment with an supported self-management program for osteoarthritis.~A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks."
10802321|NCT02022566|OG001|Outcome|Control Group|No intervention
10802322|NCT02022566|EG000|Reported Event|Supported Self-management of Osteoarthrits Program|"Treatment with an supported self-management program for osteoarthritis.~A supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks."
10802323|NCT02022566|EG001|Reported Event|Control Group|No intervention
10802324|NCT01989598|BG000|Baseline|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
10802325|NCT01989598|FG000|Participant Flow|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib orally PO QD (once daily) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
10802326|NCT01989598|OG000|Outcome|Treatment (Trametinib)|Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10802327|NCT01989598|OG001|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795)|Patients who develop progressive disease on trametinib monotherapy or achieve less then a PR after 4 cycles of treatment will have the option to continue on trametinib with the addition of GSK2141795
10802328|NCT01989598|OG000|Outcome|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
10802329|NCT01989598|OG000|Outcome|Detection of KRAS Mutations Using cfDNA|Ultra-deep sequencing will be performed on cfDNA to assess the feasibility of detecting mutations of KRAS from peripheral blood samples.
10802330|NCT01989598|OG001|Outcome|Detection of NRAS Mutations Using cfDNA|Ultra-deep sequencing will be performed on cfDNA to assess the feasibility of detecting mutations of NRAS from peripheral blood samples.
10802331|NCT01989598|OG002|Outcome|Detection of BRAF Mutations Using cfDNA|Ultra-deep sequencing will be performed on cfDNA to assess the feasibility of detecting mutations of BRAF from peripheral blood samples.
10802332|NCT01989598|EG000|Reported Event|Treatment (Trametinib, Akt Inhibitor GSK2141795)|"Patients receive trametinib orally PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or who achieve less than PR after 4 courses may also receive Akt inhibitor GSK2141795 PO daily on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO"
10802333|NCT01939275|BG000|Baseline|Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)|Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans.
10788860|NCT04460690|BG000|Baseline|Rapid Onsite COVID-29 Testing - Investigators|"Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788861|NCT04460690|BG001|Baseline|Rapid Onsite COVID-29 Testing - Participants|"Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788862|NCT04460690|BG002|Baseline|Total|Total of all reporting groups
10788863|NCT04460690|FG000|Participant Flow|Rapid Onsite COVID-29 Testing|"Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788864|NCT04460690|OG000|Outcome|Rapid Onsite COVID-29 Testing|"Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788865|NCT04460690|OG000|Outcome|Community Participants|Community participants that gave samples
10788866|NCT04460690|OG001|Outcome|Investigator Participants|The team members that participated in the testing
10788867|NCT04460690|EG000|Reported Event|Rapid Onsite COVID-29 Testing - Community Participants|"Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788868|NCT04460690|EG001|Reported Event|Rapid Onsite COVID-29 Testing - Investigator Participants|"Investigator participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.~Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2"
10788869|NCT04374019|BG000|Baseline|Arm A|Hydroxychloroquine
10788870|NCT04374019|BG001|Baseline|Arm B|Hydroxychloroquine + Azithromycin
10788871|NCT04374019|BG002|Baseline|Arm C|"Ivermectin~Ivermectin: Ivermectin:~Days 1-2: Weight < 75kg: 4 tabs (12 mg total daily dose) Days 1-2: Weight > 75kg: 5 tabs (15 mg total daily dose)"
10788872|NCT04374019|BG003|Baseline|Arm D|"Camostat Mesilate~Camostat Mesilate: Days 1-14: 2 tab TID after a meal (600 mg total daily dose)"
10788873|NCT04374019|BG004|Baseline|Total|Total of all reporting groups
10788874|NCT04374019|FG000|Participant Flow|Arm A - Hydrozychloroquine|Hydroxychloroquine 600 mg daily Days 1-14
10788875|NCT04374019|FG001|Participant Flow|Arm B - Hydroxychloroquine + Azithromycin|"Hydroxychloroquine 600 mg daily Days 1-14~+ Azithromycin 500 mg Day 1; 250 mg daily Days 2-5"
10788876|NCT04374019|FG002|Participant Flow|Arm C - Ivermectin|Ivermectin 12-15- mg (weight based) on Day 1 and 2
10788877|NCT04374019|FG003|Participant Flow|Arm D - Camostat|Camostat 200mg TID Days 1-14
10788878|NCT04374019|OG000|Outcome|Arm A|Hydroxychloroquine
10788879|NCT04374019|OG001|Outcome|Arm B|Hydroxychloroquine + Azithromycin
10788880|NCT04374019|OG002|Outcome|Arm C|Ivermectin
10788881|NCT04374019|OG003|Outcome|Arm D|Camostat
10788882|NCT04374019|EG000|Reported Event|Arm A|Hydroxychloroquine
10788883|NCT04374019|EG001|Reported Event|Arm B|Hydroxychloroquine + Azithromycin
10788884|NCT04374019|EG002|Reported Event|Arm C|Ivermectin
10788885|NCT04374019|EG003|Reported Event|Arm D|Camostat
10788886|NCT04357730|BG000|Baseline|Phase 1 Control|Phase 1 (patients 1 to 36): at randomization, patients assigned to the control group continued their current medical care according to their institution's protocols, with no input from the study team.
10788887|NCT04357730|BG001|Baseline|Phase 1 Alteplase-50 Bolus|Phase 1 (patients 1 to 36): patients randomized to tPA-Bolus intervention received an intravenous (IV) 50mg bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours. Immediately upon completion of the tPA, a 5000 unit bolus of IV unfractionated heparin (UFH) was administered and continued for the next 7 days (or until extubation) as an infusion to maintain activated partial thromboplastin time (aPTT) of 60-80 seconds. At 24 hours after tPA initiation, patients with a PaO2/FiO2 improvement that was at least 20% but did not meet the primary endpoint of a 50% improvement (i.e., 20-49% improvement) and who did not develop any of the above-mentioned exclusion criteria, received a second 50mg tPA bolus, during when the UFH infusion was halted and resumed at its prior rate as soon as the second tPA administration was complete. The heparin regimen was maintained for seven days or until successful extubation.
10788888|NCT04357730|BG002|Baseline|Phase 2 Control|Phase 2 (patients 37 to 50): at randomization, patients assigned to the control group continued their current medical care according to their institution's protocols, with no input from the study team.
10788889|NCT04357730|BG003|Baseline|Phase 2 Alteplase-50 Drip|Phase 2 (patients 37 to 50): patients randomized to the intervention received the tPA-Drip intervention consisting of a 50mg IV bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours (not to exceed 0.9mg/kg dose). Immediately following this initial tPA infusion, patients received a drip of 2 mg/hr tPA over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of a sub-therapeutic dose of 500U/hour of heparin during the tPA drip. Once the tPA drip terminated, the heparin dose was titrated up (no bolus) to maintain an aPTT 60-80 seconds.
10788890|NCT04357730|BG004|Baseline|Total|Total of all reporting groups
10788891|NCT04357730|FG000|Participant Flow|Control|Patients randomized to Control arm will receive no study medication; the treatment will be standard of care according to the institution's protocol for ARDS.
10803870|NCT01410890|OG000|Outcome|Anti-rhGAA Antibody Negative Participants|Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10788892|NCT04357730|FG001|Participant Flow|Alteplase-50 Bolus|"Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours. Re-bolusing of Alteplase, at the same dose, is permitted in those patients who show an initial transient response. The repeat dose will be given between 24 and 36 hours after the initial Alteplase administration.~Alteplase 50 MG [Activase]: Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours, given as a 10 mg push followed by the remaining 40 mgs over a total time of 2 hrs. Immediately following the Alteplase infusion, 5000 units (U) of unfractionated heparin (UFH) will be delivered and the heparin drip will be continued to maintain the activated partial thromboplastin time (aPTT) at 60-80sec (2.0 to 2.5 times the upper limit of normal). Re-bolusing of Alteplase, at the same dose, is permitted in the Alteplase-50 intervention group in those patients who show an initial transient response (>20% improvement of PaO2/FiO2 over pre-infusion of Alteplase at any of the measurements at 2, 6, 12 or 18 hours, but <50% improvement of PaO2/FiO2 at 24 hours after randomization); the repeat dose will be given between 24 and 36 hours after the initial Alteplase administration."
10788893|NCT04357730|FG002|Participant Flow|Alteplase-50 Bolus Plus Drip|"Patients randomized to Alteplase-50 plus drip group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours. Immediately following this initial Alteplase infusion, a drip of 2 mg/hr of Alteplase will be initiated over the ensuing 24 hours (total 48 mg infusion).~Alteplase 50 MG [Activase]: wed by the remaining 40 mgs over a total time of 2 hrs. Immediately following this initial Alteplase infusion, we will initiate a drip of 2 mg/hr Alteplase over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of 500 units per hour (U/hr) heparin during the Alteplase drip. After this, heparin dose will be increased slowly to maintain aPTT between 60 and 80 sec, titrated per attending's discretion."
10788894|NCT04357730|OG000|Outcome|Phase 1 Control|At randomization, patients assigned to the control group continued their current medical care according to their institution's protocols, with no input from the study team.
10788895|NCT04357730|OG001|Outcome|Alteplase-50 Bolus|Phase 1 (patients 1 to 36): patients randomized to tPA-Bolus intervention received an intravenous (IV) 50mg bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours. Immediately upon completion of the tPA, a 5000 unit bolus of IV unfractionated heparin (UFH) was administered and continued for the next 7 days (or until extubation) as an infusion to maintain activated partial thromboplastin time (aPTT) of 60-80 seconds. At 24 hours after tPA initiation, patients with a PaO2/FiO2 improvement that was at least 20% but did not meet the primary endpoint of a 50% improvement (i.e., 20-49% improvement) and who did not develop any of the above-mentioned exclusion criteria, received a second 50mg tPA bolus, during when the UFH infusion was halted and resumed at its prior rate as soon as the second tPA administration was complete. The heparin regimen was maintained for seven days or until successful extubation.
10788896|NCT04357730|OG000|Outcome|Phase 2 Control|At randomization, patients assigned to the control group continued their current medical care according to their institution's protocols, with no input from the study team.
10788897|NCT04357730|OG001|Outcome|Alteplase-50 Drip|Phase 2 (patients 37 to 50): patients randomized to the intervention received the tPA-Drip intervention consisting of a 50mg IV bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours (not to exceed 0.9mg/kg dose). Immediately following this initial tPA infusion, patients received a drip of 2 mg/hr tPA over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of a sub-therapeutic dose of 500U/hour of heparin during the tPA drip. Once the tPA drip terminated, the heparin dose was titrated up (no bolus) to maintain an aPTT 60-80 seconds.
10788898|NCT04357730|OG000|Outcome|Phase 1 Control|Patients randomized to Control arm will receive no study medication; the treatment will be standard of care according to the institution's protocol for ARDS.
10788899|NCT04357730|OG001|Outcome|Alteplase-50 Bolus|Alteplase 50 MG [Activase]: Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours, given as a 10 mg push followed by the remaining 40 mgs over a total time of 2 hrs. Immediately following the Alteplase infusion, 5000 units (U) of unfractionated heparin (UFH) will be delivered and the heparin drip will be continued to maintain the activated partial thromboplastin time (aPTT) at 60-80sec (2.0 to 2.5 times the upper limit of normal). Re-bolusing of Alteplase, at the same dose, is permitted in the Alteplase-50 intervention group in those patients who show an initial transient response (>20% improvement of PaO2/FiO2 over pre-infusion of Alteplase at any of the measurements at 2, 6, 12 or 18 hours, but <50% improvement of PaO2/FiO2 at 24 hours after randomization); the repeat dose will be given between 24 and 36 hours after the initial Alteplase administration.
10788900|NCT04357730|OG000|Outcome|Phase 2 Control|Patients randomized to Control arm will receive no study medication; the treatment will be standard of care according to the institution's protocol for ARDS.
10788901|NCT04357730|EG000|Reported Event|Control|Patients randomized to Control arm will receive no study medication; the treatment will be standard of care according to the institution's protocol for ARDS.
10965679|NCT00883233|BG000|Baseline|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
10803871|NCT01410890|OG001|Outcome|Anti-rhGAA Antibody Positive Participants|Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10965680|NCT00883233|BG001|Baseline|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
11241110|NCT02484729|OG009|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11241111|NCT02484729|OG000|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11382537|NCT00658814|OG001|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
11382538|NCT00658814|EG000|Reported Event|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
11382539|NCT00658814|EG001|Reported Event|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
11382540|NCT00658814|EG002|Reported Event|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
11382541|NCT00644228|BG000|Baseline|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382542|NCT00644228|BG001|Baseline|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382543|NCT00644228|BG002|Baseline|Total|Total of all reporting groups
11382544|NCT00644228|FG000|Participant Flow|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382545|NCT00644228|FG001|Participant Flow|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382546|NCT00644228|OG000|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11241112|NCT02484729|OG001|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11382547|NCT00644228|OG001|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382548|NCT00644228|EG000|Reported Event|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382549|NCT00644228|EG001|Reported Event|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
11382550|NCT00602641|BG000|Baseline|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~thalidomide: Given PO"
11382551|NCT00602641|BG001|Baseline|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~lenalidomide: Given PO"
11382552|NCT00602641|BG002|Baseline|Total|Total of all reporting groups
10965681|NCT00883233|BG002|Baseline|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
11241113|NCT02484729|OG002|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11241114|NCT02484729|OG003|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11241115|NCT02484729|OG004|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11241116|NCT02484729|OG005|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11382553|NCT00602641|FG000|Participant Flow|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression."
11382554|NCT00602641|FG001|Participant Flow|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
11382555|NCT00602641|OG000|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
11382556|NCT00602641|OG001|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
11382557|NCT00602641|EG000|Reported Event|MPT-T|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
11382558|NCT00602641|EG001|Reported Event|mPR-R|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
11382559|NCT00408005|BG000|Baseline|T-ALL Induction Therapy|All patients diagnosed as T-ALL for induction
11382560|NCT00408005|BG001|Baseline|T-LLy Induction Therapy|All patients diagnosed as T-LLy for induction
11382561|NCT00408005|BG002|Baseline|Total|Total of all reporting groups
11382562|NCT00408005|FG000|Participant Flow|T-ALL Induction Therapy|All patients diagnosed as T-ALL for induction
11382563|NCT00408005|FG001|Participant Flow|T-LLy Induction Therapy|All patients diagnosed as T-LLy for induction
11382564|NCT00408005|FG002|Participant Flow|T-ALL: Capizzi MTX Without Nelarabine|T-All patients who received Capizzi MTX without Nelarabine
11382565|NCT00408005|FG003|Participant Flow|T-ALL: Capizzi MTX With Nelarabine|T-All patients who received Capizzi MTX with Nelarabine
11382566|NCT00408005|FG004|Participant Flow|T-ALL: High Dose MTX Without Nelarabine|T-All patients who received High Dose MTX without Nelarabine
11382567|NCT00408005|FG005|Participant Flow|T-ALL: High Dose MTX With Nelarabine|T-All patients who received High Dose MTX with Nelarabine
11382568|NCT00408005|FG006|Participant Flow|T-LLy: Capizzi MTX Without Nelarabine|T-LLy patients who received Capizzi MTX without Nelarabine
11382569|NCT00408005|FG007|Participant Flow|T-LLy: Capizzi MTX With Nelarabine|T-LLy patients who received Capizzi MTX with Nelarabine
11382570|NCT00408005|OG000|Outcome|ARM I (Combination Chemotherapy)|No Nelarabine, Capizzi Methotrexate
11382571|NCT00408005|OG001|Outcome|ARM II (Combination Chemotherapy)|Nelarabine, Capizzi Methotrexate
11382572|NCT00408005|OG002|Outcome|ARM III (Combination Chemotherapy)|No Nelarabine, High-Dose Methotrexate
11382573|NCT00408005|OG003|Outcome|ARM IV (Combination Chemotherapy)|Nelarabine, High-Dose Methotrexate
11382574|NCT00408005|OG000|Outcome|ARM I and ARM III (Combination Chemotherapy)|No Nelarabine (Combined)
11382575|NCT00408005|OG001|Outcome|ARM II and ARM IV (Combination Chemotherapy)|Nelarabine (Combined)
11382576|NCT00408005|OG000|Outcome|ARM I and ARM II (Combination Chemotherapy)|Capizzi Methotrexate (Combined)
11382577|NCT00408005|OG001|Outcome|ARM III and ARM IV (Combination Chemotherapy)|High-Dose Methotrexate (Combined)
11382578|NCT00408005|EG000|Reported Event|T-ALL Induction Therapy|All patients diagnosed as T-ALL for induction
11382579|NCT00408005|EG001|Reported Event|T-ALL Post Induction Therapy|T-ALL patients who went off therapy at the end of induction, excluding patients who died at induction
11382580|NCT00408005|EG002|Reported Event|T-ALL: Capizzi MTX Without Nelarabine|T-All patients who received Capizzi MTX without Nelarabine
11382581|NCT00408005|EG003|Reported Event|T-ALL: Capizzi MTX With Nelarabine|T-All patients who received Capizzi MTX with Nelarabine
11382582|NCT00408005|EG004|Reported Event|T-ALL: High Dose MTX Without Nelarabine|T-All patients who received High Dose MTX without Nelarabine
11382583|NCT00408005|EG005|Reported Event|T-ALL: High Dose MTX With Nelarabine|T-All patients who received High Dose MTX with Nelarabine
11382584|NCT00408005|EG006|Reported Event|T-LLy Induction Therapy|All patients diagnosed as T-LLy for induction
11382585|NCT00408005|EG007|Reported Event|T-LLy Post Induction Therapy|T-LLy patients who went off therapy at the end of induction, excluding patients who died at induction
11241117|NCT02484729|OG006|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11241118|NCT02484729|OG007|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
10788902|NCT04357730|EG001|Reported Event|Alteplase-50 Bolus|Phase 1 (patients 1 to 36): patients randomized to tPA-Bolus intervention received an intravenous (IV) 50mg bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours. Immediately upon completion of the tPA, a 5000 unit bolus of IV unfractionated heparin (UFH) was administered and continued for the next 7 days (or until extubation) as an infusion to maintain activated partial thromboplastin time (aPTT) of 60-80 seconds. At 24 hours after tPA initiation, patients with a PaO2/FiO2 improvement that was at least 20% but did not meet the primary endpoint of a 50% improvement (i.e., 20-49% improvement) and who did not develop any of the above-mentioned exclusion criteria, received a second 50mg tPA bolus, during when the UFH infusion was halted and resumed at its prior rate as soon as the second tPA administration was complete. The heparin regimen was maintained for seven days or until successful extubation.
10788903|NCT04357730|EG002|Reported Event|Alteplase-50 Drip|Phase 2 (patients 37 to 50): patients randomized to the intervention received the tPA-Drip intervention consisting of a 50mg IV bolus of 1mg/mL tPA as a 10mg push followed by the remaining 40mg infused over the next 2 hours (not to exceed 0.9mg/kg dose). Immediately following this initial tPA infusion, patients received a drip of 2 mg/hr tPA over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of a sub-therapeutic dose of 500U/hour of heparin during the tPA drip. Once the tPA drip terminated, the heparin dose was titrated up (no bolus) to maintain an aPTT 60-80 seconds.
10788904|NCT04311463|BG000|Baseline|Paroxetine 20 mg (A) Followed by Paxil 20 mg (B)|Participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose in treatment period 1. In treatment period 2, participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods.
10788905|NCT04311463|BG001|Baseline|Paxil 20 mg (B) Followed by Paroxetine 20 mg (A)|Participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose in treatment period 1. In treatment period 2, participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods.
10788906|NCT04311463|BG002|Baseline|Total|Total of all reporting groups
10788907|NCT04311463|FG000|Participant Flow|Paroxetine 20 mg (A) Followed by Paxil 20 mg (B)|Participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose in treatment period 1. In treatment period 2, participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods.
10788908|NCT04311463|FG001|Participant Flow|Paxil 20 mg (B) Followed by Paroxetine 20 mg (A)|Participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose in treatment period 1. In treatment period 2, participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods.
10788909|NCT04311463|OG000|Outcome|Paroxetine 20 mg (Test A)|Participants received Paroxetine 20 mg (Test A) as a single oral dose in fasting condition in Periods 1 and 2
10788910|NCT04311463|OG001|Outcome|Paroxetine 20 mg (Reference B)|Participants received Paxil (Paroxetine) 20 mg (Reference B) as a single oral dose in fasting condition in Periods 1 and 2.
10788911|NCT04311463|OG000|Outcome|Paroxetine 20 mg (Test A)|Participants received Paroxetine 20 mg (Test A) as a single oral dose in fasting condition in Periods 1 and 2.
10788912|NCT04311463|EG000|Reported Event|Paroxetine 20 mg (Test A)|Participants received Paroxetine 20 mg (Test A) as a single oral dose in fasting condition in Periods 1 and 2.
10788913|NCT04311463|EG001|Reported Event|Paroxetine 20 mg (Reference B)|Participants received Paxil (Paroxetine) 20 mg (Reference B) as a single oral dose in fasting condition in Periods 1 and 2.
10788914|NCT04175509|BG000|Baseline|Rectal Acetaminophen|"Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.~Rectal acetaminophen: Rectal 1300mg"
10788915|NCT04175509|BG001|Baseline|Intravenous Acetaminophen|"Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.~Intravenous acetaminophen: Intravenous 1000mg"
10788916|NCT04175509|BG002|Baseline|Total|Total of all reporting groups
10788917|NCT04175509|FG000|Participant Flow|Rectal Acetaminophen|"Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.~Rectal acetaminophen: Rectal 1300mg"
10788918|NCT04175509|FG001|Participant Flow|Intravenous Acetaminophen|"Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.~Intravenous acetaminophen: Intravenous 1000mg"
11241119|NCT02484729|OG008|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
10788919|NCT04175509|OG000|Outcome|Rectal Acetaminophen|"Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.~Rectal acetaminophen: Rectal 1300mg"
10788920|NCT04175509|OG001|Outcome|Intravenous Acetaminophen|"Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.~Intravenous acetaminophen: Intravenous 1000mg"
10788921|NCT04175509|EG000|Reported Event|Rectal Acetaminophen|"Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.~Rectal acetaminophen: Rectal 1300mg"
10788922|NCT04175509|EG001|Reported Event|Intravenous Acetaminophen|"Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.~Intravenous acetaminophen: Intravenous 1000mg"
10788923|NCT03930186|BG000|Baseline|Apremilast|Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
10965682|NCT00883233|BG003|Baseline|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
11241120|NCT02484729|OG009|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11241121|NCT02484729|OG009|Outcome|Oral Suspension (Part B)|
11382586|NCT00408005|EG008|Reported Event|T-LLy: Capizzi MTX Without Nelarabine|T-LLy patients who received Capizzi MTX without Nelarabine
10788924|NCT03930186|FG000|Participant Flow|Apremilast|Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
10788925|NCT03930186|OG000|Outcome|Apremilast|Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
10788926|NCT03930186|EG000|Reported Event|Apremilast 30 mg|Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
10788927|NCT03740100|BG000|Baseline|Bimiralisib Treatment|Bimiralisib capsules (140 mg) orally once daily on 2 consecutive days followed by 5 days without treatment weekly.
10788928|NCT03740100|FG000|Participant Flow|Bimilralisib|"Bimiralisib capsules orally.~All patients received 140 mg bimiralisib (PQR309) 140 mg orally once daily on two consecutive days followed by five days without treatment weekly until unacceptable toxicity, tumor progression, patient's request for withdrawal, investigator judgment, or death."
10788929|NCT03740100|OG000|Outcome|Open Single Arm|"Bimiralisib capsules orally~Bimiralisib: Bimiralisib capsules"
10788930|NCT03740100|EG000|Reported Event|Open Single Arm|"Bimiralisib capsules orally~Bimiralisib: Bimiralisib capsules"
11241122|NCT02484729|OG004|Outcome|Part A - 400 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
10802334|NCT01939275|FG000|Participant Flow|Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)|Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans.
10802335|NCT01939275|OG000|Outcome|Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)|Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans.
10802336|NCT01939275|EG000|Reported Event|Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)|Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans.
10802337|NCT01922895|BG000|Baseline|Lactobacillus Rhamnosus GG|"Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.~Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG"
10802338|NCT01922895|BG001|Baseline|Placebo for Probiotic|"Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.~Placebo for Probiotic: Capsule manufactured without active ingredients."
10802339|NCT01922895|BG002|Baseline|Total|Total of all reporting groups
10802340|NCT01922895|FG000|Participant Flow|Lactobacillus Rhamnosus GG|"Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.~Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG"
10802341|NCT01922895|FG001|Participant Flow|Placebo for Probiotic|"Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.~Placebo for Probiotic: Capsule manufactured without active ingredients."
10802342|NCT01922895|OG000|Outcome|Lactobacillus Rhamnosus GG|"Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.~Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG"
10802343|NCT01922895|OG001|Outcome|Placebo for Probiotic|"Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.~Placebo for Probiotic: Capsule manufactured without active ingredients."
10802344|NCT01922895|EG000|Reported Event|Lactobacillus Rhamnosus GG|"Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.~Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG"
10965683|NCT00883233|BG004|Baseline|Total|Total of all reporting groups
11241123|NCT02484729|EG000|Reported Event|Part A- Placebo|Subjects received matching placebo under fasted conditions
11241124|NCT02484729|EG001|Reported Event|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11241125|NCT02484729|EG002|Reported Event|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11382587|NCT00408005|EG009|Reported Event|T-LLy: Capizzi MTX With Nelarabine|T-LLy patients who received Capizzi MTX with Nelarabine
11382588|NCT00378482|BG000|Baseline|Tremelimumab 15mg/kg|All Patients
11382589|NCT00378482|FG000|Participant Flow|Tremelimumab 15mg/kg|All Patients
11382590|NCT00378482|OG000|Outcome|Tremelimumab 15mg/kg|All Patients
11382591|NCT00378482|EG000|Reported Event|Tremelimumab 15mg/kg|All Patients
11382592|NCT00316888|BG000|Baseline|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382593|NCT00316888|BG001|Baseline|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382594|NCT00316888|BG002|Baseline|Total|Total of all reporting groups
11382595|NCT00316888|FG000|Participant Flow|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382596|NCT00316888|FG001|Participant Flow|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382597|NCT00316888|OG000|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382598|NCT00316888|OG001|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382599|NCT00316888|EG000|Reported Event|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382600|NCT00316888|EG001|Reported Event|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
11382601|NCT00098475|BG000|Baseline|Arm I (Lenalidomide, Dexamethasone)|"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
11382602|NCT00098475|BG001|Baseline|Arm II (Lenalidomide, Low-dose Dexamethasone)|"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
11382603|NCT00098475|BG002|Baseline|Total|Total of all reporting groups
10788931|NCT03597295|BG000|Baseline|Retifanlimab|Retifanlimab 500 mg every 4 weeks (Q4W)
10788932|NCT03597295|FG000|Participant Flow|Retifanlimab|Retifanlimab 500 mg every 4 weeks (Q4W)
10788933|NCT03597295|OG000|Outcome|Retifanlimab|Retifanlimab 500 mg every 4 weeks (Q4W)
10788934|NCT03597295|OG000|Outcome|Retifanlimab|retifanlimab 500mg every 4 weeks (Q4W)
10788935|NCT03597295|EG000|Reported Event|INCMGA 0012 500mg Q4W|INCMGA 0012 500mg Q4W
11194872|NCT02154763|OG001|Outcome|Intraperitoneal Ropivacaine|"The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual.~Ropivacaine"
11194873|NCT02154763|EG000|Reported Event|Control|Intraperitoneal Saline: 100mL normal saline administered as in intervention arm
11194874|NCT02154763|EG001|Reported Event|Intraperitoneal Ropivacaine|"The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual.~Ropivacaine"
11194875|NCT02154906|BG000|Baseline|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
11194876|NCT02154906|BG001|Baseline|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
11194877|NCT02154906|BG002|Baseline|Total|Total of all reporting groups
11194878|NCT02154906|FG000|Participant Flow|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
11194879|NCT02154906|FG001|Participant Flow|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
11241126|NCT02484729|EG003|Reported Event|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11241127|NCT02484729|EG004|Reported Event|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11241128|NCT02484729|EG005|Reported Event|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11241129|NCT02484729|EG006|Reported Event|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11241130|NCT02484729|EG007|Reported Event|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11382604|NCT00098475|FG000|Participant Flow|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
11382605|NCT00098475|FG001|Participant Flow|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
11382606|NCT00098475|FG002|Participant Flow|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
11382607|NCT00098475|FG003|Participant Flow|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
11382608|NCT00098475|OG000|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
11382609|NCT00098475|OG001|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
11382610|NCT00098475|EG000|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 1|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
11382611|NCT00098475|EG001|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
11382612|NCT00098475|EG002|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 2|Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
11382613|NCT00098475|EG003|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2|Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
11382614|NCT00098475|EG004|Reported Event|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
11382615|NCT00098475|EG005|Reported Event|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
11382616|NCT00095784|BG000|Baseline|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
11382617|NCT00095784|FG000|Participant Flow|Decitabine|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
11382618|NCT00095784|OG000|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
11382619|NCT00095784|OG000|Outcome|Arm I|"Patients receive decitabine subcutaneously on days 1-5 and 8-12.~decitabine: Given SC"
11382620|NCT00095784|EG000|Reported Event|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
11382621|NCT00070499|BG000|Baseline|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
11382622|NCT00070499|BG001|Baseline|High Dose Imatinib|
11382623|NCT00070499|BG002|Baseline|Dasatinib|
11382624|NCT00070499|BG003|Baseline|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
11382625|NCT00070499|BG004|Baseline|Total|Total of all reporting groups
11382626|NCT00070499|FG000|Participant Flow|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
11194880|NCT02154906|OG000|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
11194881|NCT02154906|OG001|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
11194882|NCT02154906|EG000|Reported Event|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
11194883|NCT02154906|EG001|Reported Event|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
11194884|NCT02155010|BG000|Baseline|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
11194885|NCT02155010|BG001|Baseline|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
11194886|NCT02155010|BG002|Baseline|Total|Total of all reporting groups
11194887|NCT02155010|FG000|Participant Flow|Dexmedetomidine Before Bupivacaine|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
11194888|NCT02155010|FG001|Participant Flow|Dexmedetomidine After Bupivacaine|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
11194889|NCT02155010|OG000|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
11382627|NCT00070499|FG001|Participant Flow|High Dose Imatinib|High dose imatinib was 800 mg daily.
11382628|NCT00070499|FG002|Participant Flow|Dasatinib|Dasatinib dose was 100 mg daily
11382629|NCT00070499|FG003|Participant Flow|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
11194890|NCT02155010|OG001|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
11194891|NCT02155010|EG000|Reported Event|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
11194892|NCT02155010|EG001|Reported Event|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
11194893|NCT02155101|BG000|Baseline|ART With 2 NRTIs Plus LPV/r (or ATV/r)|"2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).~ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir."
11241131|NCT02484729|EG008|Reported Event|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11382630|NCT00070499|OG000|Outcome|Standard Dose Imatinib A|Standard dose imatinib A
11382631|NCT00070499|OG001|Outcome|High Dose Imatinib|High dose imatinib
11382632|NCT00070499|OG002|Outcome|Dasatinib|Dasatinib
11382633|NCT00070499|OG003|Outcome|Standard Dose Imatinib B|Standard dose imatinib B
11382634|NCT00070499|OG000|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
11382635|NCT00070499|OG001|Outcome|High Dose Imatinib|
11382636|NCT00070499|OG002|Outcome|Dasatinib|
11382637|NCT00070499|OG003|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
11382638|NCT00070499|OG000|Outcome|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily
11382639|NCT00070499|OG001|Outcome|High Dose Imatinib|Patients received 800 mg imatinib daily
11382640|NCT00070499|OG002|Outcome|Dasatinib|Patients received 100 mg dasatinib daily
11382641|NCT00070499|OG003|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
11382642|NCT00070499|EG000|Reported Event|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
11382643|NCT00070499|EG001|Reported Event|High Dose Imatinib|Patients received 800 mg imatinib daily
11382644|NCT00070499|EG002|Reported Event|Dasatinib|Patients received 100 mg dasatinib daily
11382645|NCT00070499|EG003|Reported Event|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
11194894|NCT02155101|BG001|Baseline|Darunavir|"Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.~Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side."
11194895|NCT02155101|BG002|Baseline|Total|Total of all reporting groups
11194896|NCT02155101|FG000|Participant Flow|ART With 2 NRTIs Plus LPV/r (or ATV/r)|"2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).~ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir."
10965684|NCT00883233|FG000|Participant Flow|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
11194897|NCT02155101|FG001|Participant Flow|Darunavir|"Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.~Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side."
11194898|NCT02155101|OG000|Outcome|ART With 2 NRTIs Plus LPV/r (or ATV/r)|"2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).~ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir."
11194899|NCT02155101|OG001|Outcome|Darunavir|"Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.~Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side."
11194900|NCT02155101|EG000|Reported Event|ART With 2 NRTIs Plus LPV/r (or ATV/r)|"2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).~ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir."
11194901|NCT02155101|EG001|Reported Event|Darunavir|"Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.~Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side."
11194902|NCT02155257|BG000|Baseline|Modafinil|"Modafinil 200 mg will be administered orally one time~Modafinil"
11194903|NCT02155257|BG001|Baseline|Placebo|"A placebo will be administered orally one time~Placebo"
11194904|NCT02155257|BG002|Baseline|Gabapentin|"Gabapentin 900 mg will be administered orally one time~Gabapentin"
11194905|NCT02155257|BG003|Baseline|Total|Total of all reporting groups
11194906|NCT02155257|FG000|Participant Flow|Modafinil|"Modafinil 200 mg will be administered orally one time~Modafinil"
11194907|NCT02155257|FG001|Participant Flow|Placebo|"A placebo will be administered orally one time~Placebo"
10965685|NCT00883233|FG001|Participant Flow|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
10965686|NCT00883233|FG002|Participant Flow|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
10965687|NCT00883233|FG003|Participant Flow|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
11194908|NCT02155257|FG002|Participant Flow|Gabapentin|"Gabapentin 900 mg will be administered orally one time~Gabapentin"
11194909|NCT02155257|OG000|Outcome|Modafinil|"Modafinil 200 mg will be administered orally one time~Modafinil"
11194910|NCT02155257|OG001|Outcome|Placebo|"A placebo will be administered orally one time~Placebo"
10965688|NCT00883233|OG000|Outcome|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
11194911|NCT02155257|OG002|Outcome|Gabapentin|"Gabapentin 900 mg will be administered orally one time~Gabapentin"
11382646|NCT03178487|BG000|Baseline|Placebo|Participants received matching placebo orally once a day for 14 weeks in Period 1.
11382647|NCT03178487|BG001|Baseline|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day for 14 weeks in Period 1.
11382648|NCT03178487|BG002|Baseline|Total|Total of all reporting groups
11382649|NCT03178487|FG000|Participant Flow|Placebo|Participants received matching placebo orally once a day for 14 weeks in Period 1.
11382650|NCT03178487|FG001|Participant Flow|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day for 14 weeks in Period 1.
11382651|NCT03178487|OG000|Outcome|Placebo|Participants received matching placebo orally once a day for 14 weeks in Period 1.
11382652|NCT03178487|OG001|Outcome|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day for 14 weeks in Period 1.
11382653|NCT03178487|EG000|Reported Event|Placebo|Participants received matching placebo orally once a day for 14 weeks in Period 1.
11382654|NCT03178487|EG001|Reported Event|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day for 14 weeks in Period 1.
11382655|NCT03155932|BG000|Baseline|APD334|Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
11382656|NCT03155932|FG000|Participant Flow|APD334|Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
11382657|NCT03155932|OG000|Outcome|APD334|Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
11382658|NCT03155932|OG000|Outcome|APD334|Participants received APD334 1 mg tablet qd by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and PK data.
10965689|NCT00883233|OG001|Outcome|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
11194912|NCT02155257|EG000|Reported Event|Modafinil|"Modafinil 200 mg will be administered orally one time~Modafinil"
11194913|NCT02155257|EG001|Reported Event|Placebo|"A placebo will be administered orally one time~Placebo"
11382659|NCT03155932|EG000|Reported Event|APD334|Participants received APD334 1 mg tablet once daily (qd) by mouth for 12 weeks. The dose for APD334 was escalated to 2 mg at Week 12 to Week 24, based on the participant's safety and pharmacokinetic (PK) data.
11382660|NCT03106779|BG000|Baseline|Asciminib|Patients randomized to asciminib 40mg BID
11382661|NCT03106779|BG001|Baseline|Bosutinib|Patients randomized to bosutinib 500mg QD
11382662|NCT03106779|BG002|Baseline|Total|Total of all reporting groups
11382663|NCT03106779|FG000|Participant Flow|Asciminib|Patients randomized to asciminib 40mg BID
11382664|NCT03106779|FG001|Participant Flow|Bosutinib|Patients randomized to bosutinib 500mg QD
11382665|NCT03106779|OG000|Outcome|Asciminib|Patients randomized to asciminib 40mg BID
11382666|NCT03106779|OG001|Outcome|Bosutinib|Patients randomized to bosutinib 500mg QD
11382667|NCT03106779|EG000|Reported Event|Asciminib|Patients randomized to asciminib 40mg BID
11382668|NCT03106779|EG001|Reported Event|Bosutinib|Patients randomized to bosutinib 500mg QD
11382669|NCT03096834|BG000|Baseline|AMG334 140 mg DB|AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382670|NCT03096834|BG001|Baseline|Placebo DB|Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382671|NCT03096834|BG002|Baseline|Total|Total of all reporting groups
11382672|NCT03096834|FG000|Participant Flow|AMG334 140 mg DB|AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382673|NCT03096834|FG001|Participant Flow|Placebo DB|Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382674|NCT03096834|FG002|Participant Flow|AMG334 140 mg DB Cont on AMG334 140 mg|AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
11382675|NCT03096834|FG003|Participant Flow|Placebo DB to AMG334 140 mg|Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
11382676|NCT03096834|OG000|Outcome|AMG334 140 mg DB|AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382677|NCT03096834|OG001|Outcome|Placebo DB|Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382678|NCT03096834|OG000|Outcome|AMG334 140 mg - All Patients|All participants who received AMG334 during trial including participants who switched from placebo
11382679|NCT03096834|EG000|Reported Event|AMG334 140 mg DB|AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382680|NCT03096834|EG001|Reported Event|Placebo DB|Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
11382681|NCT03096834|EG002|Reported Event|AMG334 140 mg DB Cont on AMG334 140 mg|AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
11382682|NCT03096834|EG003|Reported Event|Placebo DB to AMG334 140 mg|Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
11382683|NCT03089853|BG000|Baseline|Intervention Arm|Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
11382684|NCT03089853|BG001|Baseline|Usual Care Arm|Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
11382685|NCT03089853|BG002|Baseline|Total|Total of all reporting groups
10788959|NCT03053362|BG000|Baseline|Major Depressive Disorder Population|"100 Individuals with DSM-5-defined MDD, aged 18-65~All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.~Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.~Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788960|NCT03053362|BG001|Baseline|Healthy Control Population|"50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788961|NCT03053362|BG002|Baseline|Total|Total of all reporting groups
10788962|NCT03053362|FG000|Participant Flow|Major Depressive Disorder Population|"100 Individuals with DSM-5-defined MDD, aged 18-65~All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.~Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.~Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788963|NCT03053362|FG001|Participant Flow|Healthy Control Population|"50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788964|NCT03053362|OG000|Outcome|Major Depressive Disorder Population|"100 Individuals with DSM-5-defined MDD, aged 18-65~All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.~Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.~Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788965|NCT03053362|OG001|Outcome|Healthy Control Population|"50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788966|NCT03053362|OG001|Outcome|Healthy Control Participants|50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
10788967|NCT03053362|EG000|Reported Event|Major Depressive Disorder Population|"100 Individuals with DSM-5-defined MDD, aged 18-65~All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.~Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.~Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10965690|NCT00883233|OG002|Outcome|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
11194914|NCT02155257|EG002|Reported Event|Gabapentin|"Gabapentin 900 mg will be administered orally one time~Gabapentin"
10788968|NCT03053362|EG001|Reported Event|Healthy Control Population|"50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education~THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
10788969|NCT02849626|BG000|Baseline|Perampanel 0.5 mg/mL: POS|Core Phase: Participants with POS received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788970|NCT02849626|BG001|Baseline|Perampanel 0.5 mg/mL: PGTC Seizures|Core Phase: Participants with PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788971|NCT02849626|BG002|Baseline|Total|Total of all reporting groups
10788972|NCT02849626|FG000|Participant Flow|Perampanel 0.5 mg/mL: POS|Core Phase: Participants with partial onset-seizures (POS) received perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension titrated beyond 8 milligram per day (mg/day) up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any enzyme-inducing antiepileptic drug [EIAED]), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788973|NCT02849626|FG001|Participant Flow|Perampanel 0.5 mg/mL: PGTC Seizures|Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788974|NCT02849626|OG000|Outcome|Perampanel 0.5 mg/mL: All Participants|Core Phase: Participants with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788975|NCT02849626|OG000|Outcome|Perampanel: POS|All participants with POS who received perampanel 0.5 mg/mL oral suspension (for participants with age less than [<] 12 years) or tablets (for participants with age >=12 years) titrated to a dose of up to 8 mg/day for up to 23 weeks in studies E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695) and this current study (E2007-G000-311).
10788976|NCT02849626|OG001|Outcome|Perampanel: PGTC Seizures|All participants with PGTC seizures who received perampanel 0.5 mg/mL oral suspension (for participants with age <12 years) or tablets (for participants with age >=12 years) titrated to a dose of up to 8 mg/day for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311).
10788977|NCT02849626|OG000|Outcome|Perampanel: Participants Aged (<12 Years)|All non-Asian participants with POS, received perampanel oral suspension (participants with age <12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day for up to 23 weeks in this current study E2007-G000-311.
10802345|NCT01922895|EG001|Reported Event|Placebo for Probiotic|"Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.~Placebo for Probiotic: Capsule manufactured without active ingredients."
11194915|NCT02155283|BG000|Baseline|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
11194916|NCT02155283|FG000|Participant Flow|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
11382686|NCT03089853|FG000|Participant Flow|Intervention Arm|Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
11382687|NCT03089853|FG001|Participant Flow|Usual Care Arm|Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
11382688|NCT03089853|OG000|Outcome|Intervention Arm|Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
11382689|NCT03089853|OG001|Outcome|Usual Care Arm|Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
11382690|NCT03089853|EG000|Reported Event|Intervention Arm|Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
11382691|NCT03089853|EG001|Reported Event|Usual Care Arm|Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
11382692|NCT03070392|BG000|Baseline|Tebentafusp|Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
11382693|NCT03070392|BG001|Baseline|Investigator's Choice|1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
11382694|NCT03070392|BG002|Baseline|Total|Total of all reporting groups
11382695|NCT03070392|FG000|Participant Flow|Tebentafusp|Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
11382696|NCT03070392|FG001|Participant Flow|Investigator's Choice: Dacarbazine|Dacarbazine administered at 1,000 mg/m^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.
11382697|NCT03070392|FG002|Participant Flow|Investigator's Choice: Ipilimumab|Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.
11382698|NCT03070392|FG003|Participant Flow|Investigator's Choice: Pembrolizumab|Pembrolizumab administered at 2 mg/kg IV infusion over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
11382699|NCT03070392|OG000|Outcome|Tebentafusp|Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
11382700|NCT03070392|OG001|Outcome|Investigator's Choice|1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
11382701|NCT03070392|EG000|Reported Event|Tebentafusp|Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
11382702|NCT03070392|EG001|Reported Event|Investigator's Choice|1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
11382703|NCT03048578|BG000|Baseline|Saxenda|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day"
11382704|NCT03048578|BG001|Baseline|Placebo|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Placebo: Subcutaneous Saline Solution"
10965691|NCT00883233|OG003|Outcome|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
11382705|NCT03048578|BG002|Baseline|Total|Total of all reporting groups
10788978|NCT02849626|OG001|Outcome|Perampanel: Participants Aged (>=12 Years)|All non-Asian participants with POS, received perampanel tablets (participants with age >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day for up to 23 weeks in studies E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695).
10802346|NCT01901289|BG000|Baseline|Drug-Eluting Stent|Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11194917|NCT02155283|OG000|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
10788979|NCT02849626|OG000|Outcome|Perampanel: Without Topiramate|All participants with PGTC seizures received perampanel as oral suspension (aged <12 years) or as oral tablets (aged >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day without topiramate for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311).
10788980|NCT02849626|OG001|Outcome|Perampanel: With Topiramate|All participants with PGTC seizures received perampanel as oral suspension (aged <12 years) or as oral tablets (aged >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day along with topiramate for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311).
10788981|NCT02849626|OG000|Outcome|Perampanel: POS|All participants with POS who received perampanel 0.5 mg/mL oral suspension (for participants with age <12 years) or tablets (for participants with age >=12 years) titrated to a dose of up to 8 mg/day for up to 23 weeks in studies E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695) and this current study (E2007-G000-311).
10788982|NCT02849626|OG000|Outcome|Perampanel 0.5 mg/mL: POS|Core Phase: Participants with POS received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788983|NCT02849626|OG001|Outcome|Perampanel 0.5 mg/mL: PGTC Seizures|Core Phase: Participants with PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788984|NCT02849626|OG000|Outcome|Perampanel 0.5 mg/mL: 4 to <7 Years|Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788985|NCT02849626|OG001|Outcome|Perampanel 0.5 mg/mL: 7 to <12 Years|Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10788986|NCT02849626|EG000|Reported Event|Perampanel 0.5 mg/mL: POS|Core Phase: Participants with POS received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10802347|NCT01901289|FG000|Participant Flow|Drug-Eluting Stent|Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
10802348|NCT01901289|OG000|Outcome|Drug-Eluting Stent|Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
10802349|NCT01901289|EG000|Reported Event|Drug-Eluting Stent|Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11194918|NCT02155283|EG000|Reported Event|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
11194919|NCT02155309|BG000|Baseline|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
10788987|NCT02849626|EG001|Reported Event|Perampanel 0.5 mg/mL: PGTC Seizures|Core Phase: Participants with PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
10965692|NCT00883233|EG000|Reported Event|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
10965693|NCT00883233|EG001|Reported Event|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
10965694|NCT00883233|EG002|Reported Event|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
10965695|NCT00883233|EG003|Reported Event|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
10966624|NCT00887822|EG001|Reported Event|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
10966625|NCT00887913|BG000|Baseline|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
10966626|NCT00887913|FG000|Participant Flow|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
10966627|NCT00887913|OG000|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
10966628|NCT00887913|EG000|Reported Event|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
10966629|NCT00887926|BG000|Baseline|Cohort 1 - 5mg/kg IMC-EB10|IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966630|NCT00887926|BG001|Baseline|Cohort 2 - 10 mg/kg IMC-EB10|IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966631|NCT00887926|BG002|Baseline|Cohort 3 - 20 mg/kg IMC-EB10|IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966632|NCT00887926|BG003|Baseline|Cohort 4 - 30 mg/kg IMC-EB10|IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966633|NCT00887926|BG004|Baseline|Total|Total of all reporting groups
10789002|NCT02654132|BG000|Baseline|Experiemental Arm|Elotuzumab + Pomalidomide + Dexamethasone
10789003|NCT02654132|BG001|Baseline|Control Arm|Pomalidomide + Dexamethasone
10789004|NCT02654132|BG002|Baseline|Total|Total of all reporting groups
10789005|NCT02654132|FG000|Participant Flow|Experiemental Arm|Elotuzumab + Pomalidomide + Dexamethasone
10789006|NCT02654132|FG001|Participant Flow|Control Arm|Pomalidomide + Dexamethasone
10966634|NCT00887926|FG000|Participant Flow|Cohort 1 - 5mg/kg IMC-EB10 (LY3012218)|IMC-EB10: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966635|NCT00887926|FG001|Participant Flow|Cohort 2 - 10 mg/kg IMC-EB10|IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966636|NCT00887926|FG002|Participant Flow|Cohort 3 - 20 mg/kg IMC-EB10|IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966637|NCT00887926|FG003|Participant Flow|Cohort 4 - 30 mg/kg IMC-EB10|IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966638|NCT00887926|OG000|Outcome|IMC-EB10 5 to 30 mg/kg|Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
10966639|NCT00887926|OG000|Outcome|Cohort 1 - 5mg/kg IMC-EB10|IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966640|NCT00887926|OG001|Outcome|Cohort 2 - 10 mg/kg IMC-EB10|IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966641|NCT00887926|OG002|Outcome|Cohort 3 - 20 mg/kg IMC-EB10|IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966642|NCT00887926|OG003|Outcome|Cohort 4 - 30 mg/kg IMC-EB10|IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966643|NCT00887926|OG000|Outcome|Cohort 1 5mg/kg IMC-EB10|IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966644|NCT00887926|EG000|Reported Event|Cohort 1 - 5mg/kg IMC-EB10|IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966645|NCT00887926|EG001|Reported Event|Cohort 2 - 10 mg/kg IMC-EB10|IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966646|NCT00887926|EG002|Reported Event|Cohort 3 - 20 mg/kg IMC-EB10|IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10966647|NCT00887926|EG003|Reported Event|Cohort 4 - 30 mg/kg IMC-EB10|IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
10789007|NCT02654132|OG000|Outcome|Experiemental Arm|Elotuzumab + Pomalidomide + Dexamethasone
10789008|NCT02654132|OG001|Outcome|Control Arm|Pomalidomide + Dexamethasone
10789009|NCT02654132|OG000|Outcome|Experimental Arm|Elotuzumab + Pomalidomide + Dexamethasone
10789010|NCT02654132|EG000|Reported Event|Elotuzimab - Pomalidomide|"Biological: Elotuzumab (BMS-901608; HuLuc63) Solution Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1)~Drug: Pomalidomide Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst~Drug: Dexamethasone -Subjects ≤ 75 years old:~Tablets, Oral,28 mg, once daily on:~Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)~Solution, Intravenous(IV), 8 mg, once daily on:~Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)~Tablets, Oral,40 mg, once daily on:~Days 8,15,22(Cycle 3 and Beyond)~-Subjects > 75 years old:~Tablets, Oral,8 mg, once daily on:~Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)~Solution, Intravenous(IV), 8 mg, once daily on:~Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)~Tablets, Oral, 20 mg, once daily on:~Days 8,15,22(Cycle 3 and Beyond)~Other Names:~Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak"
10789011|NCT02654132|EG001|Reported Event|Pomalidomide|"Drug: Pomalidomide~• Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst~Drug: Dexamethasone~Subjects ≤ 75 years old:~• Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22~Subjects > 75 years old:~• Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22,~Other Names:~Decadron~Dexamethasone Intensol~Dexpak~Taperpak"
10789012|NCT02603432|BG000|Baseline|Avelumab + Best Supportive Care (BSC)|Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789013|NCT02603432|BG001|Baseline|Best Supportive Care|As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789014|NCT02603432|BG002|Baseline|Total|Total of all reporting groups
10789015|NCT02603432|FG000|Participant Flow|Avelumab + Best Supportive Care (BSC)|Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789016|NCT02603432|FG001|Participant Flow|Best Supportive Care|As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789017|NCT02603432|OG000|Outcome|Avelumab + Best Supportive Care (BSC)|Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
11241132|NCT02484729|EG009|Reported Event|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
10789018|NCT02603432|OG001|Outcome|Best Supportive Care|As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789019|NCT02603432|EG000|Reported Event|Avelumab + Best Supportive Care (BSC)|Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789020|NCT02603432|EG001|Reported Event|Best Supportive Care|As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
10789021|NCT02600923|BG000|Baseline|Palbociclib+Letrozole|Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
11241133|NCT02484807|BG000|Baseline|Bosentan + Sildenafil|"Combination treatment with Bosentan + Sildenafil at baseline~no intervention, only observation of different groups"
10789022|NCT02600923|FG000|Participant Flow|Palbociclib+Letrozole|Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
10789023|NCT02600923|OG000|Outcome|Palbociclib+Letrozole|Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
10789024|NCT02600923|EG000|Reported Event|Palbociclib+Letrozole|Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
10789025|NCT02597790|BG000|Baseline|Group A (HIV/HCV Coinfected)|HIV+, HCV viremic at study entry
10789026|NCT02597790|BG001|Baseline|Group B (HIV Monoinfected)|HIV+, HCV negative at study entry
10789027|NCT02597790|BG002|Baseline|Total|Total of all reporting groups
10789028|NCT02597790|FG000|Participant Flow|Group A (HIV/HCV Coinfected)|HIV+, HCV viremic at study entry
10789029|NCT02597790|FG001|Participant Flow|Group B (HIV Monoinfected)|HIV+, HCV negative at study entry
10789030|NCT02597790|OG000|Outcome|Group A (HIV/HCV Coinfected)|HIV+, HCV viremic at study entry
10789031|NCT02597790|OG001|Outcome|Group B (HIV Monoinfected)|HIV+, HCV negative at study entry
10789032|NCT02597790|OG000|Outcome|Group A (HIV/HCV Coinfected)|HIV+/HCV viremic
10789033|NCT02597790|OG001|Outcome|Group B (HIV Monoinfected)|HIV+/HCV-
10789034|NCT02597790|OG000|Outcome|Group A (HIV/HCV Coinfected)|HIV+/HCV+, HCV treated
10789035|NCT02597790|OG001|Outcome|Group B (HIV Monoinfected)|HIV+/HCV- at study entry
10789036|NCT02597790|OG000|Outcome|Group A (HIV/HCV Coinfected)|HIV+/HCV viremic, HCV treated
10789037|NCT02597790|EG000|Reported Event|Group A (HIV/HCV Coinfected)|HIV+, HCV viremic at study entry
10789038|NCT02597790|EG001|Reported Event|Group B (HIV Monoinfected)|HIV+, HCV negative at study entry
10789039|NCT02484664|BG000|Baseline|Celecoxib|"Celecoxib 200mg PO QD for 6 months~Celecoxib: We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months."
10789040|NCT02484664|FG000|Participant Flow|Celecoxib|"Celecoxib 200mg PO QD for 6 months~Celecoxib: We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months."
10789041|NCT02484664|OG000|Outcome|Celecoxib|"Celecoxib 200mg PO QD for 6 months~Celecoxib: We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months."
10789042|NCT02484664|EG000|Reported Event|Celecoxib|"Celecoxib 200mg PO QD for 6 months~Celecoxib: We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months."
10789043|NCT02412735|BG000|Baseline|Rexlemestrocel-L|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).
10789044|NCT02412735|BG001|Baseline|Rexlemestrocel-L + HA|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).
10789045|NCT02412735|BG002|Baseline|Placebo|Participants received saline solution as matching-placebo on Day 0 (Visit 2).
10789046|NCT02412735|BG003|Baseline|Total|Total of all reporting groups
10789047|NCT02412735|FG000|Participant Flow|Rexlemestrocel-L|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).
10789048|NCT02412735|FG001|Participant Flow|Rexlemestrocel-L + HA|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).
11241134|NCT02484807|BG001|Baseline|Bosentan + Tadalafil|"Combination treatment with Bosentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789049|NCT02412735|FG002|Participant Flow|Placebo|Participants received saline solution as matching-placebo on Day 0 (Visit 2).
10789050|NCT02412735|OG000|Outcome|Rexlemestrocel-L|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).
10789051|NCT02412735|OG001|Outcome|Rexlemestrocel-L + HA|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).
10789052|NCT02412735|OG002|Outcome|Placebo|Participants received saline solution as matching-placebo on Day 0 (Visit 2).
10789053|NCT02412735|EG000|Reported Event|Rexlemestrocel-L|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2).
10789054|NCT02412735|EG001|Reported Event|Rexlemestrocel-L + HA|Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).
10789055|NCT02412735|EG002|Reported Event|Placebo|Participants received saline solution as matching-placebo on Day 0 (Visit 2).
10789056|NCT02371889|BG000|Baseline|Topiramate + Medical Management|"Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789057|NCT02371889|BG001|Baseline|Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789058|NCT02371889|BG002|Baseline|Total|Total of all reporting groups
10789059|NCT02371889|FG000|Participant Flow|Topiramate + Medical Management|"Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789060|NCT02371889|FG001|Participant Flow|Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789061|NCT02371889|OG000|Outcome|Topiramate + Medical Management|"Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789062|NCT02371889|OG001|Outcome|Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789063|NCT02371889|OG000|Outcome|Genotype CC Topiramate + Medical Management|"Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789064|NCT02371889|OG001|Outcome|Genotype CC Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789065|NCT02371889|OG002|Outcome|Genotype AA/AC Topiramate + Medical Management|"opiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789066|NCT02371889|OG003|Outcome|Genotype AA/AC Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789067|NCT02371889|EG000|Reported Event|Topiramate + Medical Management|"Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10789068|NCT02371889|EG001|Reported Event|Placebo Pill + Medical Management|"Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking."
10802350|NCT01831895|BG000|Baseline|MobiusHD™|"MobiusHD™~MobiusHD™: Implant that is placed in the carotid sinus to control hypertension."
10802351|NCT01831895|FG000|Participant Flow|MobiusHD™|"MobiusHD™~MobiusHD™: Implant that is placed in the carotid sinus to control hypertension."
10802352|NCT01831895|OG000|Outcome|MobiusHD™|"MobiusHD™~MobiusHD™: Implant that is placed in the carotid sinus to control hypertension."
10802353|NCT01831895|EG000|Reported Event|MobiusHD™|"MobiusHD™~MobiusHD™: Implant that is placed in the carotid sinus to control hypertension."
10802354|NCT01831076|BG000|Baseline|Exemestane|"Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.~Exemestane: Given PO"
10802355|NCT01831076|BG001|Baseline|Exemestane Plus Tamoxifen|preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
10802356|NCT01831076|BG002|Baseline|Total|Total of all reporting groups
10802357|NCT01831076|FG000|Participant Flow|Exemestane|"Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.~Exemestane: Given PO"
10802358|NCT01831076|FG001|Participant Flow|Exemestane Plus Tamoxifen|preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
10802359|NCT01831076|OG000|Outcome|Exemestane|"Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.~Exemestane: Given PO"
10802360|NCT01831076|OG001|Outcome|Exemestane Plus Tamoxifen|preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
10965696|NCT00883246|BG000|Baseline|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965697|NCT00883246|FG000|Participant Flow|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965698|NCT00883246|OG000|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 - 3) at time of enrollment.
10965699|NCT00883246|OG000|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 - 6) at time of enrollment
10965700|NCT00883246|OG000|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965701|NCT00883246|OG000|Outcome|Claudicant Subgroup (Baseline)|"All claudicant subjects enrolled in this single-arm study were treated with directional atherectomy and had walking distance measured prior to treatment.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965702|NCT00883246|OG001|Outcome|Claudicant Subgroup (One Year)|"All claudicant subjects (RCC 1-3) enrolled in this single-arm study were treated with directional atherectomy and walking distance measured at the one year follow-up visit.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965703|NCT00883246|OG000|Outcome|Claudicant Subjects|Subjects who had claudication (RCC of 1 - 3) at time of enrollment.
10965704|NCT00883246|OG000|Outcome|CLI Subgroup|Wound healing was assessed in subjects who had Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
10965705|NCT00883246|EG000|Reported Event|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
10965706|NCT00883337|BG000|Baseline|Teriflunomide 7 mg / 14 mg|"Core treatment period: Teriflunomide 7 mg once daily~Extension treatment period: Teriflunomide 14 mg once daily"
10965707|NCT00883337|BG001|Baseline|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
10965708|NCT00883337|BG002|Baseline|IFNβ1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
10965709|NCT00883337|BG003|Baseline|Total|Total of all reporting groups
10965710|NCT00883337|FG000|Participant Flow|Teriflunomide 7 mg/14 mg|"Core treatment period: Teriflunomide 7 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
10965711|NCT00883337|FG001|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
10965712|NCT00883337|FG002|Participant Flow|IFN-β-1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
10965713|NCT00883337|OG000|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
10965714|NCT00883337|OG001|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
10965715|NCT00883337|OG002|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
10965716|NCT00883337|OG000|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10965717|NCT00883337|OG001|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
10965718|NCT00883337|OG002|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
10965719|NCT00883337|EG000|Reported Event|Core Treatment Period: Teriflunomide 7 mg|Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
10965720|NCT00883337|EG001|Reported Event|Core Treatment:Teriflunomide 14 mg|Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
10965721|NCT00883337|EG002|Reported Event|Core Treatment: IFN-β-1a|Interferon β-1a 3 times a week (mean exposure of 405.18 days).
10965722|NCT00883337|EG003|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 7 mg)|Teriflunomide 14 mg once daily in extended treatment period after 7 mg in the core treatment period (mean exposure of 996.76 days).
10965723|NCT00883337|EG004|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 14 mg)|Teriflunomide 14 mg once daily in extended treatment period after 14 mg in core treatment period (mean exposure of 1015.32 days).
10965724|NCT00883337|EG005|Reported Event|Extended Treatment: Teriflunomide 14 mg (After IFN-β-1a)|Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
10965725|NCT00883389|BG000|Baseline|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
10965726|NCT00883389|FG000|Participant Flow|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
10965727|NCT00883389|OG000|Outcome|Med-alert Pilot Group|Participants in pilot study assigned a med-alert device of bracelet or necklace
10965728|NCT00883389|EG000|Reported Event|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
10965729|NCT00883415|BG000|Baseline|Intervention|
10965730|NCT00883415|FG000|Participant Flow|Pre-post Intervention Evaluation|Changes in myocardial glucose uptake were evaluated in each participant before and after anemia treatment with darbepoetin alfa.
10965731|NCT00883415|OG000|Outcome|Intervention|
10965732|NCT00883415|EG000|Reported Event|Intervention|
10965733|NCT00883493|BG000|Baseline|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
10965734|NCT00883493|BG001|Baseline|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
10965735|NCT00883493|BG002|Baseline|Total|Total of all reporting groups
10966648|NCT00887965|BG000|Baseline|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
10965736|NCT00883493|FG000|Participant Flow|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
10965737|NCT00883493|FG001|Participant Flow|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
10965738|NCT00883493|OG000|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
10789092|NCT02121158|BG000|Baseline|Optimal Medical Therapy|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
10789093|NCT02121158|BG001|Baseline|Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
10789094|NCT02121158|BG002|Baseline|Total|Total of all reporting groups
10789095|NCT02121158|FG000|Participant Flow|Optimal Medical Therapy|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
10789096|NCT02121158|FG001|Participant Flow|Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
10789097|NCT02121158|OG000|Outcome|Optimal Medical Therapy|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
10789098|NCT02121158|OG001|Outcome|Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
10789099|NCT02121158|EG000|Reported Event|Optimal Medical Therapy|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
10789100|NCT02121158|EG001|Reported Event|Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
10789101|NCT02100722|BG000|Baseline|FFR Guided PCI|Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
10789102|NCT02100722|BG001|Baseline|CABG|CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
10789103|NCT02100722|BG002|Baseline|Total|Total of all reporting groups
10789104|NCT02100722|FG000|Participant Flow|FFR Guided PCI|Patients undergoing Percutaneous Coronary Intervention (PCI) will have Fractional Flow Reserve (FFR) measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent as per usual routine.
10789105|NCT02100722|FG001|Participant Flow|CABG|Coronary-artery bypass grafting (CABG) performed per clinical routine (both off-pump and on-pump surgery acceptable).
10789106|NCT02100722|OG000|Outcome|FFR Guided PCI|Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
10789107|NCT02100722|OG001|Outcome|CABG|CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
10789108|NCT02100722|OG000|Outcome|CABG|CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
10789109|NCT02100722|EG000|Reported Event|FFR Guided PCI|Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
11241135|NCT02484807|BG002|Baseline|Ambrisentan + Sildenafil|"Combination treatment with Ambrisentan + Sildenafil at baseline~no intervention, only observation of different groups"
10789110|NCT02100722|EG001|Reported Event|CABG|CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
10789111|NCT02046096|BG000|Baseline|Günther Tulip® Vena Cava Filter|"Günther Tulip® Vena Cava Filter~Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789112|NCT02046096|BG001|Baseline|Cook Celect® Vena Cava Filters|"Cook Celect® Vena Cava Filters~Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789113|NCT02046096|BG002|Baseline|Total|Total of all reporting groups
10789114|NCT02046096|FG000|Participant Flow|Günther Tulip® Vena Cava Filter|"Günther Tulip® Vena Cava Filter~Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789115|NCT02046096|FG001|Participant Flow|Cook Celect® Vena Cava Filters|"Cook Celect® Vena Cava Filters~Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789116|NCT02046096|OG000|Outcome|Cook Celect® Vena Cava Filters|"Cook Celect® Vena Cava Filters~Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789117|NCT02046096|OG001|Outcome|Günther Tulip® Vena Cava Filter|"Günther Tulip® Vena Cava Filter~Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789118|NCT02046096|OG002|Outcome|Total|Combined Patient Population
10789119|NCT02046096|OG000|Outcome|Cook Celect® Vena Cava Filters|"Cook Celect® Vena Cava Filter~Cook Celect® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10966649|NCT00887965|FG000|Participant Flow|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
11382706|NCT03048578|FG000|Participant Flow|Saxenda|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day"
11382707|NCT03048578|FG001|Participant Flow|Placebo|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Placebo: Subcutaneous Saline Solution"
11382708|NCT03048578|OG000|Outcome|Saxenda|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day"
11382709|NCT03048578|OG001|Outcome|Placebo|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Placebo: Subcutaneous Saline Solution"
11382710|NCT03048578|EG000|Reported Event|Saxenda|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day"
11382711|NCT03048578|EG001|Reported Event|Placebo|"Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day~Placebo: Subcutaneous Saline Solution"
11382712|NCT03015194|BG000|Baseline|Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option|The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
11382713|NCT03015194|FG000|Participant Flow|Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option|The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
11382714|NCT03015194|OG000|Outcome|Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option|The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE)or intracardiac echocardiography.
11382715|NCT03015194|OG000|Outcome|Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option|The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
11382716|NCT03015194|EG000|Reported Event|Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option|The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
11382717|NCT03012815|BG000|Baseline|Gabapentin|"Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.~Gabapentin: Gabapentin administered as a taper~Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)"
11382718|NCT03012815|BG001|Baseline|Benzodiazepine|"Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.~Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol"
11382719|NCT03012815|BG002|Baseline|Total|Total of all reporting groups
11382720|NCT03012815|FG000|Participant Flow|Gabapentin|"Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.~Gabapentin: Gabapentin administered as a taper~Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)"
11382721|NCT03012815|FG001|Participant Flow|Benzodiazepine|"Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.~Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol"
11382722|NCT03012815|OG000|Outcome|Gabapentin|"Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.~Gabapentin: Gabapentin administered as a taper~Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)"
11382723|NCT03012815|OG001|Outcome|Benzodiazepine|"Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.~Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol"
11382724|NCT03012815|OG000|Outcome|Gabapentin|"Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal.~Gabapentin: Gabapentin administered as a taper~Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)"
11382725|NCT03012815|EG000|Reported Event|Gabapentin|"Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.~Gabapentin: Gabapentin administered as a taper~Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)"
11382726|NCT03012815|EG001|Reported Event|Benzodiazepine|"Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.~Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol"
10789120|NCT02046096|EG000|Reported Event|Cook Celect® Vena Cava Filters|"Cook Celect® Vena Cava Filters~Cook Celect® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789121|NCT02046096|EG001|Reported Event|Günther Tulip® Vena Cava Filter|"Günther Tulip® Vena Cava Filter~Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism"
10789122|NCT01945775|BG000|Baseline|Talazoparib|Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
10789123|NCT01945775|BG001|Baseline|Physician's Choice Treatment|Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
10789124|NCT01945775|BG002|Baseline|Total|Total of all reporting groups
10789125|NCT01945775|FG000|Participant Flow|Talazoparib|Participants received talazoparib 1 milligram (mg), orally, once daily until radiographic disease progression as determined by the central independent radiology facility (IRF), unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
10789126|NCT01945775|FG001|Participant Flow|Physician's Choice Treatment|Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 milligram per meter square (mg/m^2) orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute intravenous (IV) infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
10789127|NCT01945775|OG000|Outcome|Talazoparib|Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
10789128|NCT01945775|OG001|Outcome|Physician's Choice Treatment|Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
10789129|NCT01945775|EG000|Reported Event|Talazoparib|Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
10789130|NCT01945775|EG001|Reported Event|Physician's Choice Treatment|Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
10789131|NCT01781637|BG000|Baseline|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
10789132|NCT01781637|BG001|Baseline|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
10789133|NCT01781637|BG002|Baseline|Total|Total of all reporting groups
10789134|NCT01781637|FG000|Participant Flow|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
10789135|NCT01781637|FG001|Participant Flow|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
10789136|NCT01781637|OG000|Outcome|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
10789137|NCT01781637|OG001|Outcome|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
10789138|NCT01781637|EG000|Reported Event|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
10789139|NCT01781637|EG001|Reported Event|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
10789166|NCT01670539|BG000|Baseline|Telemonitor and Routine Care for Patients With lungCa|"PI left the institution and demographic information was not broken down into arms.~Telemonitor:~In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.~HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).~Routine care for patients with lungCa:~Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months."
10802361|NCT01831076|EG000|Reported Event|Exemestane|"Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.~Exemestane: Given PO"
10802362|NCT01831076|EG001|Reported Event|Exemestane Plus Tamoxifen|preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with >T2 ER+ Her2- BC.
10802363|NCT01595581|BG000|Baseline|Testosterone|Testosterone: 8 weeks 200mg dose testosterone enanthate
10802364|NCT01595581|BG001|Baseline|Placebo|Saline: Placebo for 8 weeks
10965739|NCT00883493|OG001|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
10789167|NCT01670539|FG000|Participant Flow|Telemonitor|"In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.~HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain)."
10789168|NCT01670539|FG001|Participant Flow|Routine Care for Patients With lungCa|Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.
10789169|NCT01670539|OG000|Outcome|Telemonitor and Routine Care for Patients With lungCa|"PI left the institution and demographic information was not broken down into arms.~Telemonitor:~In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.~HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).~Routine care for patients with lungCa:~Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months."
10802365|NCT01595581|BG002|Baseline|Total|Total of all reporting groups
11194920|NCT02155309|BG001|Baseline|Efficacy: All Study Participants (Crossover, Double-Blind)|Double-blind, placebo-controlled, cross-over design. Study medications (0.2 mg of intranasal scopolamine and 0.2 mg of intranasal placebo) were randomized, blinded, and delivered in identical containers. Each subject participated in two sessions separated by minimum of one week, each session identical except for contents of intranasal spray. Order of treatment and placebo administration randomized. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
11194921|NCT02155309|BG002|Baseline|Total|Total of all reporting groups
11194922|NCT02155309|FG000|Participant Flow|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
11194923|NCT02155309|FG001|Participant Flow|Efficacy: Scopolamine, Then Placebo|Subjects received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
11194924|NCT02155309|FG002|Participant Flow|Efficacy: Placebo, Then Scopolamine|Subjects received one dose of 0.2 mg intranasal placebo (0.1 mg per nostril) for the first of two Efficacy sessions, and then one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) for the second Efficacy session. A minimum of one week separated the two sessions. Each session was identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation.
11194925|NCT02155309|OG000|Outcome|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
11241136|NCT02484807|BG003|Baseline|Ambrisentan + Tadalafil|"Combination treatment with Ambrisentan + Tadalafil at baseline~no intervention, only observation of different groups"
11241137|NCT02484807|BG004|Baseline|Macitentan + Sildenafil|"Combination treatment with Macitentan + Sildenafil at baseline~no intervention, only observation of different groups"
11241138|NCT02484807|BG005|Baseline|Macitentan + Tadalafil|"Combination treatment with Macitentan + Tadalafil at baseline~no intervention, only observation of different groups"
11241139|NCT02484807|BG006|Baseline|Total|Total of all reporting groups
10802366|NCT01595581|FG000|Participant Flow|Testosterone|Testosterone: 8 weeks supraphysiologic dose testosterone enanthate
10802367|NCT01595581|FG001|Participant Flow|Placebo|Saline: Placebo for 8 weeks
10802368|NCT01595581|OG000|Outcome|Testosterone|Testosterone: 8 weeks supraphysiologic dose testosterone enanthate. Ethnicity: 4 White, 2 Asian, 1 Black
10789170|NCT01670539|OG000|Outcome|Telemonitor|"In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.~HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain)."
10789171|NCT01670539|OG001|Outcome|Routine Care for Patients With lungCa|Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.
10789172|NCT01670539|EG000|Reported Event|Telemonitor|"In addition to routine care, the HomMed Telemonitor wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.~HomMed Telemonitor: A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses."
10789173|NCT01670539|EG001|Reported Event|Routine Care for Patients With lungCa|Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.
10802369|NCT01595581|OG001|Outcome|Placebo|"Saline: Placebo for 8 weeks~Ethnicity: 4 White, 1 Asian, 2 Hispanic"
10802370|NCT01595581|OG000|Outcome|Testosterone|Testosterone: 8 weeks supraphysiologic dose testosterone enanthate
10802371|NCT01595581|OG001|Outcome|Placebo|Saline: Placebo for 8 weeks
10802372|NCT01595581|EG000|Reported Event|Testosterone|Testosterone: 8 weeks supraphysiologic dose testosterone enanthate
10802373|NCT01595581|EG001|Reported Event|Placebo|Saline: Placebo for 8 weeks
10802374|NCT01514682|BG000|Baseline|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
10802375|NCT01514682|BG001|Baseline|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
10802376|NCT01514682|BG002|Baseline|Total|Total of all reporting groups
10802377|NCT01514682|FG000|Participant Flow|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
10802378|NCT01514682|FG001|Participant Flow|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
10802379|NCT01514682|OG000|Outcome|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
10802380|NCT01514682|OG001|Outcome|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
10802381|NCT01514682|EG000|Reported Event|Placebo|"Placebo pills to be assigned using a permuted randomization system~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose~Placebo: Non-medication pills; To be taken in morning and evening intervals."
11382727|NCT03001011|BG000|Baseline|Placebo|Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <= 4.6 mg/dL (<=1.49 mmol/L).
11382728|NCT03001011|BG001|Baseline|Renvela|Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
11382729|NCT03001011|BG002|Baseline|Total|Total of all reporting groups
11382730|NCT03001011|FG000|Participant Flow|Placebo|Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (<=) 4.6 mg/dL (<=1.49 mmol/L).
11382731|NCT03001011|FG001|Participant Flow|Renvela|Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
11382732|NCT03001011|OG000|Outcome|Placebo|Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <= 4.6 mg/dL (<=1.49 mmol/L).
11382733|NCT03001011|OG001|Outcome|Renvela|Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
11382734|NCT03001011|OG000|Outcome|Placebo|Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <= 4.6 mg/dL [<=1.49 mmol/L]).
11382735|NCT03001011|EG000|Reported Event|Placebo|Participants received placebo (for Renvela) orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
11382736|NCT03001011|EG001|Reported Event|Renvela|Participants received Renvela orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
11382737|NCT02999633|BG000|Baseline|Isatuximab|Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
11382738|NCT02999633|FG000|Participant Flow|Isatuximab|Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
11382739|NCT02999633|OG000|Outcome|Isatuximab|Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
11382740|NCT02999633|EG000|Reported Event|Isatuximab|Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
11382741|NCT02993757|BG000|Baseline|CYD Dengue Vaccine + Gardasil (Concomitant Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Day 0 and Month 6. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM, concomitantly with the first 2 doses of CYD dengue vaccine.
11382742|NCT02993757|BG001|Baseline|CYD Dengue Vaccine + Gardasil (Sequential Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Month 1 and Month 7. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the first 2 doses of CYD dengue vaccine.
11382743|NCT02993757|BG002|Baseline|Total|Total of all reporting groups
11382744|NCT02993757|FG000|Participant Flow|CYD Dengue Vaccine + Gardasil (Concomitant Administration)|"Dengue immune participants (i.e., titers greater than or equal to (>=)10 (1/dilution [dil]) for at least one serotype with the parental dengue virus strains in the baseline sample) received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12; whereas dengue non-immune participants (i.e., titers less than (<)10 (1/dil) for all serotypes with parental dengue virus strains with available and valid results in the baseline sample) received only 2 doses of CYD vaccine at Day 0 and Month 6. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL Intramuscular (IM), concomitantly with the first 2 doses of CYD dengue vaccine."
11382745|NCT02993757|FG001|Participant Flow|CYD Dengue Vaccine + Gardasil (Sequential Administration)|"Dengue immune participants (i.e., titers >=10 (1/dil) for at least one serotype with the parental dengue virus strains in the baseline sample) received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13; whereas dengue non-immune participants (i.e., titers <10 (1/dil) for all serotypes with parental dengue virus strains with available and valid results in the baseline sample) received only 2 doses of CYD vaccine at Month 1 and Month 7. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the first 2 doses of CYD dengue vaccine."
11382746|NCT02993757|OG000|Outcome|CYD Dengue Vaccine + Gardasil (Concomitant Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Day 0 and Month 6. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM, concomitantly with the first 2 doses of CYD dengue vaccine.
11382747|NCT02993757|OG001|Outcome|CYD Dengue Vaccine + Gardasil (Sequential Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Month 1 and Month 7. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the first 2 doses of CYD dengue vaccine.
10789174|NCT00407602|BG000|Baseline|Implant of Argus II Retinal Prosthesis|"This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.~Argus II Retinal Stimulation System: epiretinal implantation of device"
10789175|NCT00407602|FG000|Participant Flow|Implant of Argus II Retinal Prosthesis|"This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.~Argus II Retinal Stimulation System: epiretinal implantation of device"
10789176|NCT00407602|OG000|Outcome|Single Arm|Only one arm in this study, treatment arm.
10789177|NCT00407602|OG000|Outcome|Single Arm|Single arm with fellow eye as comparator
10789178|NCT00407602|OG000|Outcome|Implant of Argus II Retinal Prosthesis|"This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.~Implant of Argus II Retinal Prosthesis: epiretinal implantation of device"
10789179|NCT00407602|OG000|Outcome|Implant of Argus II Retinal Prosthesis|"This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.~Argus II Retinal Stimulation System: epiretinal implantation of device"
10789180|NCT00407602|EG000|Reported Event|Single Arm|Single arm with fellow eye as comparator
10802382|NCT01514682|EG001|Reported Event|Anti-inflammatory Combination Therapy|"Salsalate, statin and omega-3-fatty acid combination therapy~Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
10802383|NCT01453140|BG000|Baseline|Cyclophosphamide and Sirolimus|Patients will be treated in sequential cohorts of 5. In cohort A, the first 5 enrolled patients will be receive cyclophosphamide and sirolimus only
10802384|NCT01453140|FG000|Participant Flow|Cyclophosphamide and Sirolimus Only|"Cyclophosphamide = 4g/m2 IV Sirolimus = 6 mg PO x 1; 2 mg PO~No patients were enrolled in the Cyclophosphamide, Sirolimus, IL-2 arm or the Cyclophosphamide, Sirolimus, IL-2, azacitidine arm"
10802385|NCT01453140|OG000|Outcome|Cyclophosphamide and Sirolimus|Patients will be treated in sequential cohorts of 5. In cohort A, the first 5 enrolled patients will be receive cyclophosphamide and sirolimus only
10802386|NCT01453140|OG001|Outcome|Low Dose IL-2 With Cytoxan + Sirolimus|Patients in treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus.
10802387|NCT01453140|OG002|Outcome|Low Dose IL-2, Vidaza, Cytoxan & Sirolimus|Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza)
10802388|NCT01453140|EG000|Reported Event|Cyclophosphamide and Sirolimus|Cyclophosphamide and Sirolimus - Patients will be treated in sequential cohorts of 5. In cohort A, the first 5 enrolled patients will be receive cyclophosphamide and sirolimus only
11241140|NCT02484807|FG000|Participant Flow|Bosentan + Sildenafil|"Combination treatment with Bosentan + Sildenafil at baseline~no intervention, only observation of different groups"
11241141|NCT02484807|FG001|Participant Flow|Bosentan + Tadalafil|"Combination treatment with Bosentan + Tadalafil at baseline~no intervention, only observation of different groups"
10802389|NCT01453140|EG001|Reported Event|Low Dose IL-2 With Cytoxan + Sirolimus|Low dose IL-2 with Cyclophosphamide + Sirolimus - In cohort B, the next 5 patients will additionally receive cyclophosphamide and sirolimus & low-dose IL-2 Low dose IL-2, low dose Vidaza, Cyclophosphamide & Sirolimus
10802390|NCT01453140|EG002|Reported Event|Low Dose IL-2, Vidaza, Cytoxan & Sirolimus|Low dose IL-2, Vidaza, Cytoxan & Sirolimus - In cohort C the next 5 enrolled patients will additionally receive cyclophosphamide and Sirolimus, low-dose IL-2 and low-dose Vidaza
10802391|NCT01408641|BG000|Baseline|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
10802392|NCT01408641|BG001|Baseline|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
10802393|NCT01408641|BG002|Baseline|Total|Total of all reporting groups
10802394|NCT01408641|FG000|Participant Flow|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
10802395|NCT01408641|FG001|Participant Flow|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
10802396|NCT01408641|OG000|Outcome|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
10802397|NCT01408641|OG001|Outcome|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
10802398|NCT01408641|EG000|Reported Event|Topiramate|"Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.~Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose."
11241142|NCT02484807|FG002|Participant Flow|Ambrisentan + Sildenafil|"Combination treatment with Ambrisentan + Sildenafil at baseline~no intervention, only observation of different groups"
10802399|NCT01408641|EG001|Reported Event|Placebo (Sugar Pill)|"Placebo arm will receive matching capsules without topiramate.~Placebo: Placebo capsules without topiramate"
10802400|NCT01032265|BG000|Baseline|Postal Treatment|Information (including life style), and PFMT exercises.
10802401|NCT01032265|BG001|Baseline|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
10802402|NCT01032265|BG002|Baseline|Total|Total of all reporting groups
10802403|NCT01032265|FG000|Participant Flow|Postal Treatment|Information (including life style), and PFMT exercises.
10802404|NCT01032265|FG001|Participant Flow|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
11241143|NCT02484807|FG003|Participant Flow|Ambrisentan + Tadalafil|"Combination treatment with Ambrisentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789181|NCT05143541|BG000|Baseline|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10789182|NCT05143541|FG000|Participant Flow|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10789183|NCT05143541|OG000|Outcome|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10789184|NCT05143541|EG000|Reported Event|AEON Endostapler|"Stapling performed with AEON Endostapler~AEON Endostapler: Surgery with AEON Endostapler"
10789185|NCT04685213|BG000|Baseline|Active E-Stim (Phase I)|Subjects enrolled in Phase I will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
10789186|NCT04685213|BG001|Baseline|Sham E-Stim (Phase I)|Subjects enrolled in Phase I will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
10789187|NCT04685213|BG002|Baseline|Total|Total of all reporting groups
10789188|NCT04685213|FG000|Participant Flow|Active E-Stim (Phase I)|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
10789189|NCT04685213|FG001|Participant Flow|Sham E-Stim (Phase I)|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
10789190|NCT04685213|OG000|Outcome|Active E-Stim (Phase I)|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
11194926|NCT02155309|OG001|Outcome|Efficacy: Scopolamine and Placebo (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
11194927|NCT02155309|EG000|Reported Event|PK: Scopolamine Only, Open-label|Baseline vitals, blood draw, and cognitive testing applied. Subjects then received one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril). No placebo or efficacy. Blood draws, vitals collection, cognitive testing, and subjective fatigue collected for approximately eight hours post-dose.
11194928|NCT02155309|EG001|Reported Event|Efficacy: Scopolamine (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
11194929|NCT02155309|EG002|Reported Event|Efficacy: Placebo (Crossover, Double-blind)|Subjects received either one dose of 0.2 mg intranasal scopolamine (0.1 mg per nostril) or one dose of 0.2 mg placebo intranasal (0.1 mg per nostril) for two Efficacy sessions. Each session identical except for contents of intranasal spray. Baseline vitals, blood draw, and cognitive testing applied prior to dosage. Approximately 40 minutes post-dose, subjects experience mechanical rotation via Coriolis cross-coupling in a stairwise progression until subject reported either full minute of unabated stomach awareness, or the maximum rotation of 40 rpm obtained. Blood draws, vitals collection, cognitive testing and subjective fatigue collected for approximately three hours post-rotation. One week minimum separated the two Efficacy sessions.
10789191|NCT04685213|OG001|Outcome|Sham E-Stim (Phase I)|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
10789192|NCT04685213|EG000|Reported Event|Active E-Stim (Phase I)|During Phase I of the study, four electrode pads will be placed in the proximal and distal gastrocnemius muscle of each participant in order to receive electrical stimulation therapy for 1 hour during hospitalization for an average of 2 weeks. Adverse events related to electrical stimulation therapy (i.e., pain, muscle damage, skin irritation) will be collected.
10789193|NCT04685213|EG001|Reported Event|Sham E-Stim (Phase I)|During Phase I of the study, four electrode pads will be placed in the proximal and distal gastrocnemius muscle of each participant in order to receive electrical stimulation therapy for 1 hour during hospitalization for an average of 2 weeks. Adverse events related to electrical stimulation therapy (i.e., pain, muscle damage, skin irritation) will be collected. However, the sham group will receive an inactive device. So, electrical stimulation will only be provided to quantify the study outcomes. Adverse events will also be reported during this time.
10789194|NCT04567186|BG000|Baseline|All Dispensed Subjects|All subjects dispensed at least one study lens
10789195|NCT04567186|FG000|Participant Flow|Test/Control/Control|Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens in an bilateral fashion during both the second and third study periods.
10789196|NCT04567186|FG001|Participant Flow|Control/Test/Test|Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens in an bilateral fashion during both the second and third study periods
10789197|NCT04567186|OG000|Outcome|Test|Subjects that wore the Test lens during any of the three study periods
10789198|NCT04567186|OG001|Outcome|Control|Subjects that wore the Control lens during any of the three study periods.
10789199|NCT04567186|EG000|Reported Event|Test|Subjects that wore the Test lens during any of the three study periods.
10789200|NCT04567186|EG001|Reported Event|Control|Subjects that wore the Control lens during any of the three study periods.
10802405|NCT01032265|OG000|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
10802406|NCT01032265|OG001|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
10802407|NCT01032265|EG000|Reported Event|Postal Treatment|Information (including life style), and PFMT exercises.
10966650|NCT00887965|OG000|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
11194930|NCT02155322|BG000|Baseline|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
10789201|NCT04065074|BG000|Baseline|FX006 32 mg|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
10789202|NCT04065074|FG000|Participant Flow|FX006 32 mg|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
10789203|NCT04065074|OG000|Outcome|FX006 32 mg|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
10789204|NCT04065074|EG000|Reported Event|FX006 32 mg|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
10789205|NCT03980730|BG000|Baseline|Azeliragon|"Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1)~Azeliragon: Azeliragon 5 mg capsule administered orally, once daily"
10789206|NCT03980730|BG001|Baseline|Placebo|"Matching placebo capsule administered orally, once daily for 6 months (Part 1)~Placebo: Matching placebo capsule administered orally, once daily"
10789207|NCT03980730|BG002|Baseline|Total|Total of all reporting groups
10789208|NCT03980730|FG000|Participant Flow|Azeliragon|"Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1)~Azeliragon: Azeliragon 5 mg capsule administered orally, once daily"
10789209|NCT03980730|FG001|Participant Flow|Placebo|"Matching placebo capsule administered orally, once daily for 6 months (Part 1)~Placebo: Matching placebo capsule administered orally, once daily"
10789210|NCT03980730|OG000|Outcome|Azeliragon|"Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1)~Azeliragon: Azeliragon 5 mg capsule administered orally, once daily"
11194931|NCT02155322|FG000|Participant Flow|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
11194932|NCT02155322|OG000|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
11194933|NCT02155322|EG000|Reported Event|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
11194934|NCT02155335|BG000|Baseline|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
10789211|NCT03980730|OG001|Outcome|Placebo|"Matching placebo capsule administered orally, once daily for 6 months (Part 1)~Placebo: Matching placebo capsule administered orally, once daily"
10789212|NCT03980730|EG000|Reported Event|Azeliragon|"Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1)~Azeliragon: Azeliragon 5 mg capsule administered orally, once daily"
10789213|NCT03980730|EG001|Reported Event|Placebo|"Matching placebo capsule administered orally, once daily for 6 months (Part 1)~Placebo: Matching placebo capsule administered orally, once daily"
10789214|NCT03793010|BG000|Baseline|FX006|"FX006 32mg~FX006: Single Intra-articular injection"
10789215|NCT03793010|BG001|Baseline|Normal Saline|"Normal Saline~Normal saline: Single Intra-articular injection"
10789216|NCT03793010|BG002|Baseline|Total|Total of all reporting groups
10789217|NCT03793010|FG000|Participant Flow|FX006|"FX006 32mg~FX006: Single Intra-articular injection"
10789218|NCT03793010|FG001|Participant Flow|Normal Saline|"Normal Saline~Normal saline: Single Intra-articular injection"
10789219|NCT03793010|OG000|Outcome|FX006|"FX006 32mg~FX006: Single Intra-articular injection"
10789220|NCT03793010|OG001|Outcome|Normal Saline|"Normal Saline~Normal saline: Single Intra-articular injection"
10789221|NCT03793010|EG000|Reported Event|FX006|"FX006 32mg~FX006: Single Intra-articular injection"
10789222|NCT03793010|EG001|Reported Event|Normal Saline|"Normal Saline~Normal saline: Single Intra-articular injection"
10789223|NCT03644017|BG000|Baseline|WRAPSODY Stent Graft|"All subjects will receive treatment via WRAPSODY Stent Graft Placement.~WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein"
10789224|NCT03644017|FG000|Participant Flow|WRAPSODY Stent Graft|"All subjects will receive treatment via WRAPSODY Stent Graft Placement.~WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein"
10789225|NCT03644017|OG000|Outcome|WRAPSODY Stent Graft|"All subjects will receive treatment via WRAPSODY Stent Graft Placement.~WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein"
10789226|NCT03644017|EG000|Reported Event|WRAPSODY Stent Graft|"All subjects will receive treatment via WRAPSODY Stent Graft Placement.~WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein"
10789227|NCT03592186|BG000|Baseline|Parenting Wisely+|"Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.~Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum~Treatment as Usual: The active comparator is residential treatment as usual"
10789228|NCT03592186|BG001|Baseline|Treatment as Usual|"The active comparator is defined as residential treatment services as usual.~Treatment as Usual: The active comparator is residential treatment as usual"
10789229|NCT03592186|BG002|Baseline|Total|Total of all reporting groups
10802408|NCT01032265|EG001|Reported Event|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
11241144|NCT02484807|FG004|Participant Flow|Macitentan + Sildenafil|"Combination treatment with Macitentan + Sildenafil at baseline~no intervention, only observation of different groups"
10789230|NCT03592186|FG000|Participant Flow|Parenting Wisely+|"Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.~Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum~Treatment as Usual: The active comparator is residential treatment as usual"
10789231|NCT03592186|FG001|Participant Flow|Treatment as Usual|"The active comparator is defined as residential treatment services as usual.~Treatment as Usual: The active comparator is residential treatment as usual"
10789232|NCT03592186|OG000|Outcome|Parenting Wisely+|"Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.~Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum~Treatment as Usual: The active comparator is residential treatment as usual"
10789233|NCT03592186|OG001|Outcome|Treatment as Usual|"The active comparator is defined as residential treatment services as usual.~Treatment as Usual: The active comparator is residential treatment as usual"
10789234|NCT03592186|EG000|Reported Event|Parenting Wisely+|"Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.~Parenting Wisely+: Parenting Wisely+ consists of access to the Parenting Wisely computer program, paired with engagement strategies: up to four parent coaching sessions, daily text messages, and access to an online networking forum~Treatment as Usual: The active comparator is residential treatment as usual"
10789235|NCT03592186|EG001|Reported Event|Treatment as Usual|"The active comparator is defined as residential treatment services as usual.~Treatment as Usual: The active comparator is residential treatment as usual"
10789236|NCT03529942|BG000|Baseline|Total Population|All patients who received any amount of FX006 32mg
10789237|NCT03529942|FG000|Participant Flow|FX006 32mg|All patients who received any amount of FX006 32mg
10965740|NCT00883493|EG000|Reported Event|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
11194935|NCT02155335|FG000|Participant Flow|Prefilled Syringe→Smartject™ Device|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
10789238|NCT03529942|OG000|Outcome|Total Population|All patients who received a single intra-articular (IA) injection of FX006 32mg and had a pre-treatment synovial volume measurement
10789239|NCT03529942|OG001|Outcome|Patients With Baseline Synovitis|The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm^3 of gadolinium enhancement as determined by quantitative image analysis
10789240|NCT03529942|OG000|Outcome|Total Population|All patients who received a single intra-articular (IA) injection of FX006 32 mg and had a pre-treatment synovial volume measurement
10789241|NCT03529942|EG000|Reported Event|Total Population|All patients who received an attempted single intra-articular (IA) injection of FX006 32 mg
10789242|NCT03529942|EG001|Reported Event|Patients With Baseline Synovitis|The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm^3 of gadolinium enhancement as determined by quantitative image analysis
10789243|NCT03349775|BG000|Baseline|Metformin|Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
10789244|NCT03349775|BG001|Baseline|Placebo|Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
10789245|NCT03349775|BG002|Baseline|Total|Total of all reporting groups
10789246|NCT03349775|FG000|Participant Flow|Metformin|Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
10789247|NCT03349775|FG001|Participant Flow|Placebo|Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
10789248|NCT03349775|OG000|Outcome|Metformin|Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
10789249|NCT03349775|OG001|Outcome|Placebo|Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
10789250|NCT03349775|EG000|Reported Event|Metformin|Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
10789251|NCT03349775|EG001|Reported Event|Placebo|Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
10789252|NCT03292471|BG000|Baseline|Inhibitory Only|Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
10789253|NCT03292471|BG001|Baseline|Excitatory Primed|The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
10789254|NCT03292471|BG002|Baseline|Total|Total of all reporting groups
10789255|NCT03292471|FG000|Participant Flow|Inhibitory Only|Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
10965741|NCT00883493|EG001|Reported Event|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
10789256|NCT03292471|FG001|Participant Flow|Excitatory Primed|The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which consisted of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
10789257|NCT03292471|OG000|Outcome|Inhibitory Only|Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
10789258|NCT03292471|OG001|Outcome|Excitatory Primed|The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
10789259|NCT03292471|EG000|Reported Event|Inhibitory Only|Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
10789260|NCT03292471|EG001|Reported Event|Excitatory Primed|The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which consisted of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
10789261|NCT03256344|BG000|Baseline|Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC)|Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789262|NCT03256344|BG001|Baseline|Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC)|Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
11194936|NCT02155335|FG001|Participant Flow|Smartject™ Device→ Prefilled Syringe|Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
10789263|NCT03256344|BG002|Baseline|Total|Total of all reporting groups
10789264|NCT03256344|FG000|Participant Flow|Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC)|Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789265|NCT03256344|FG001|Participant Flow|Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC)|Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789266|NCT03256344|OG000|Outcome|Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC)|Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789267|NCT03256344|OG001|Outcome|Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC)|Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789268|NCT03256344|EG000|Reported Event|Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC)|Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
10789269|NCT03256344|EG001|Reported Event|Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC)|Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
11194937|NCT02155335|OG000|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
10789270|NCT03207815|BG000|Baseline|Filgotinib|Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789271|NCT03207815|BG001|Baseline|Placebo|Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789272|NCT03207815|BG002|Baseline|Total|Total of all reporting groups
10789273|NCT03207815|FG000|Participant Flow|Filgotinib|Participants received filgotinib 200 milligrams (mg) tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789274|NCT03207815|FG001|Participant Flow|Placebo|Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789275|NCT03207815|OG000|Outcome|Filgotinib|Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789276|NCT03207815|OG001|Outcome|Placebo|Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
11194938|NCT02155335|EG000|Reported Event|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
11194939|NCT02155465|BG000|Baseline|Phase 1: Level 1|Level 1 (10mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
10789277|NCT03207815|EG000|Reported Event|Filgotinib|Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
11194940|NCT02155465|BG001|Baseline|Phase 1: Level 2|Level 2 (15mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
11194941|NCT02155465|BG002|Baseline|Phase 1: Level 3|Level 3 (20mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
10789278|NCT03207815|EG001|Reported Event|Placebo|Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
10789279|NCT03077737|BG000|Baseline|Population Health Management|"Population health management for smoking cessation in low-income smokers: the Choose to Change intervention~Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy)."
10789280|NCT03077737|BG001|Baseline|Enhanced Usual Care|"Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment~Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit."
10789281|NCT03077737|BG002|Baseline|Total|Total of all reporting groups
10789282|NCT03077737|FG000|Participant Flow|Population Health Management|"Population health management for smoking cessation in low-income smokers: the Choose to Change intervention~Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy)."
10789283|NCT03077737|FG001|Participant Flow|Enhanced Usual Care|"Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment~Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit."
10789284|NCT03077737|OG000|Outcome|Population Health Management|"Population health management for smoking cessation in low-income smokers: the Choose to Change intervention~Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy)."
10789285|NCT03077737|OG001|Outcome|Enhanced Usual Care|"Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment~Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit."
11194942|NCT02155465|BG003|Baseline|Phase 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD|20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD
11194943|NCT02155465|BG004|Baseline|PHASE 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd
11194944|NCT02155465|BG005|Baseline|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd
10789286|NCT03077737|EG000|Reported Event|Population Health Management|"Population health management for smoking cessation in low-income smokers: the Choose to Change intervention~Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy)."
11194945|NCT02155465|BG006|Baseline|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd
11194946|NCT02155465|BG007|Baseline|Total|Total of all reporting groups
11194947|NCT02155465|FG000|Participant Flow|Phase 1: Level 1|Level 1 (10mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
11194948|NCT02155465|FG001|Participant Flow|Phase 1: Level 2|Level 2 (15mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
11194949|NCT02155465|FG002|Participant Flow|Phase 1: Level 3|Level 3 (20mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib)
11194950|NCT02155465|FG003|Participant Flow|PHASE 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD|20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD
10789287|NCT03077737|EG001|Reported Event|Enhanced Usual Care|"Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment~Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit."
10789288|NCT02991937|BG000|Baseline|Medical Therapy|"Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration"
10789289|NCT02991937|BG001|Baseline|Surgical Intervention|"Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration~Surgical Treatment: Appendectomy"
10789290|NCT02991937|BG002|Baseline|Total|Total of all reporting groups
10789291|NCT02991937|FG000|Participant Flow|Medical Therapy|"Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration"
10789292|NCT02991937|FG001|Participant Flow|Surgical Intervention|"Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration~Surgical Treatment: Appendectomy"
10789293|NCT02991937|OG000|Outcome|Medical Therapy|"Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration"
10789294|NCT02991937|OG001|Outcome|Surgical Intervention|"Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration~Surgical Treatment: Appendectomy"
10789295|NCT02991937|EG000|Reported Event|Medical Therapy|"Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration"
10789296|NCT02991937|EG001|Reported Event|Surgical Intervention|"Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.~Piperacillin/Tazobactam: 24 hours of IV antibiotic administration~Surgical Treatment: Appendectomy"
10789297|NCT02968563|BG000|Baseline|Tirabrutinib + Idelalisib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks.
10789298|NCT02968563|BG001|Baseline|Tirabrutinib + Idelalisib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses on Day 1 of Weeks 2, 3, 5, and then every 4 weeks through Week 21.
10789299|NCT02968563|BG002|Baseline|Total|Total of all reporting groups
11382748|NCT02993757|EG000|Reported Event|CYD Dengue Vaccine + Gardasil (Concomitant Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Day 0 and Month 6. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM, concomitantly with the first 2 doses of CYD dengue vaccine.
10789300|NCT02968563|FG000|Participant Flow|Tirabrutinib + Idelalisib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks.
11194951|NCT02155465|FG004|Participant Flow|PHASE 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd
10789301|NCT02968563|FG001|Participant Flow|Tirabrutinib + Idelalisib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses on Day 1 of Weeks 2, 3, 5, and then every 4 weeks through Week 21.
10789302|NCT02968563|OG000|Outcome|Tirabrutinib + Idelalisib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks.
10802409|NCT00653068|BG000|Baseline|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
10802410|NCT00653068|BG001|Baseline|Stratum II|Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
10789303|NCT02968563|OG001|Outcome|Tirabrutinib + Idelalisib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses on Day 1 of Weeks 2, 3, 5, and then every 4 weeks through Week 21.
10789304|NCT02968563|EG000|Reported Event|Tirabrutinib + Idelalisib|Tirabrutinib 80 mg (4 x 20 mg tablets/2 x 40 mg tablets/1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks.
10789305|NCT02968563|EG001|Reported Event|Tirabrutinib + Idelalisib + Obinutuzumab|Tirabrutinib 80 mg (4 x 20 mg tablets/ 2 x 40 mg tablets/ 1 x 80 mg tablet) orally once daily + idelalisib 100 mg (1 x 100 mg tablet) orally once daily for up to 104 weeks + obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously over 21 weeks.
10789306|NCT02915783|BG000|Baseline|Lenvatinib 18 mg/Day + Everolimus 5 mg/Day|Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
10789307|NCT02915783|FG000|Participant Flow|Lenvatinib 18 mg/Day + Everolimus 5 mg/Day|Participants received initial dose of lenvatinib 18 milligrams per day (mg/day) (one 10-milligram [mg] capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
10789308|NCT02915783|OG000|Outcome|Lenvatinib 18 mg/Day + Everolimus 5 mg/Day|Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
10789309|NCT02915783|EG000|Reported Event|Lenvatinib 18 mg/Day + Everolimus 5 mg/Day|Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
10789310|NCT02913482|BG000|Baseline|Exploratory Part 1 - Cohort 1|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 1 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 1 was targeting an exposure of mean AUC0-24h,ss 700 ng*h/mL.
10789311|NCT02913482|BG001|Baseline|Exploratory Part 1 - Cohort 2|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 2 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 2 was targeting an exposure of mean AUC0-24h,ss </= 2000 ng*h/mL. Cohort 2 included one infant who started at Dose Level 1 and was escalated to Dose Level 2 on Day 83.
10789312|NCT02913482|BG002|Baseline|Confirmatory Part 2 - Risdiplam|Participants received risdiplam orally once daily at a dose of target exposure cap of a mean AUC0-24h,ss of 2000 ng*h/mL, for a duration of 24 months with a primary analysis after 12 months. Starting doses were either 0.04mg/kg, 0.08mg/kg or 0.2mg/kg depending on the participant's age. All participants had their dose adjusted to 0.2mg/kg within a few months of starting treatment. The dose was adjusted to 0.25mg/kg when participant reached 2 years of age.
10789313|NCT02913482|BG003|Baseline|Total|Total of all reporting groups
10789314|NCT02913482|FG000|Participant Flow|Exploratory Part 1 - Cohort 1|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 1 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 1 was targeting an exposure of mean AUC0-24h,ss 700 ng*h/mL.
10789315|NCT02913482|FG001|Participant Flow|Exploratory Part 1 - Cohort 2|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 2 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 2 was targeting an exposure of mean AUC0-24h,ss </= 2000 ng*h/mL. Cohort 2 included one infant who started at Dose Level 1 and was escalated to Dose Level 2 on Day 83.
10789316|NCT02913482|FG002|Participant Flow|Confirmatory Part 2 - Risdiplam|Participants received risdiplam orally once daily at a dose of target exposure cap of a mean AUC0-24h,ss of 2000 ng*h/mL, for a duration of 24 months with a primary analysis after 12 months. Starting doses were either 0.04mg/kg, 0.08mg/kg or 0.2mg/kg depending on the participant's age. All participants had their dose adjusted to 0.2mg/kg within a few months of starting treatment. The dose was adjusted to 0.25mg/kg when participant reached 2 years of age.
10789317|NCT02913482|OG000|Outcome|Exploratory Part 1 - Risdiplam|Infants aged between 28 days (1 month) of life and 210 days (7 months) received risdiplam orally or by bolus via naso-gastric or gastrostomy tube.
11194952|NCT02155465|FG005|Participant Flow|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd
11194953|NCT02155465|FG006|Participant Flow|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd
11194954|NCT02155465|OG000|Outcome|Phase I Participants|Phase I The study will follow a standard 3+3 dose escalation trial design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (21 days) before a dose escalation decision is made.
10789318|NCT02913482|OG000|Outcome|Confirmatory Part 2 - Risdiplam|Participants received risdiplam orally once daily at a dose of target exposure cap of a mean AUC0-24h,ss of 2000 ng*h/mL, for a duration of 24 months with a primary analysis after 12 months. Starting doses were either 0.04mg/kg, 0.08mg/kg or 0.2mg/kg depending on the participant's age. All participants had their dose adjusted to 0.2mg/kg within a few months of starting treatment. The dose was adjusted to 0.25mg/kg when participant reached 2 years of age.
10789319|NCT02913482|OG000|Outcome|Exploratory Part 1 - Cohort 1|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 1 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 1 was targeting an exposure of mean AUC0-24h,ss 700 ng*h/mL.
10789320|NCT02913482|OG001|Outcome|Exploratory Part 1 - Cohort 2|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 2 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 2 was targeting an exposure of mean AUC0-24h,ss </= 2000 ng*h/mL. Cohort 2 included one infant who started at Dose Level 1 and was escalated to Dose Level 2 on Day 83.
10789321|NCT02913482|OG002|Outcome|Confirmatory Part 2 - Risdiplam|Participants received risdiplam orally once daily at a dose of target exposure cap of a mean AUC0-24h,ss of 2000 ng*h/mL, for a duration of 24 months with a primary analysis after 12 months. Starting doses were either 0.04mg/kg, 0.08mg/kg or 0.2mg/kg depending on the participant's age. All participants had their dose adjusted to 0.2mg/kg within a few months of starting treatment. The dose was adjusted to 0.25mg/kg when participant reached 2 years of age.
10789322|NCT02913482|EG000|Reported Event|Exploratory Part 1 - Cohort 1|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 1 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 1 was targeting an exposure of mean AUC0-24h,ss 700 ng*h/mL.
10789323|NCT02913482|EG001|Reported Event|Exploratory Part 1 - Cohort 2|Participants received risdiplam in a staggered, dose-escalation manner once daily at Dose Level 2 for a minimum of 4 weeks to select the dose for Part 2. Dose Level 2 was targeting an exposure of mean AUC0-24h,ss </= 2000 ng*h/mL. Cohort 2 included one infant who started at Dose Level 1 and was escalated to Dose Level 2 on Day 83.
10789324|NCT02913482|EG002|Reported Event|Confirmatory Part 2 - Risdiplam|Participants received risdiplam orally once daily at a dose of target exposure cap of a mean AUC0-24h,ss of 2000 ng*h/mL, for a duration of 24 months with a primary analysis after 12 months. Starting doses were either 0.04mg/kg, 0.08mg/kg or 0.2mg/kg depending on the participant's age. All participants had their dose adjusted to 0.2mg/kg within a few months of starting treatment. The dose was adjusted to 0.25mg/kg when participant reached 2 years of age.
10789325|NCT02787044|BG000|Baseline|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine"
10789326|NCT02787044|BG001|Baseline|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine"
10789327|NCT02787044|BG002|Baseline|Total|Total of all reporting groups
10789328|NCT02787044|FG000|Participant Flow|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine"
10789329|NCT02787044|FG001|Participant Flow|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine"
10789330|NCT02787044|OG000|Outcome|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)"
10789331|NCT02787044|OG001|Outcome|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note primary analysis is of participant-seasons (n = 3577)"
11194955|NCT02155465|OG001|Outcome|Phase II Participants|Phase II Once the MTD has been determined, patients will be enrolled in the phase 2 portion of the single-arm, two-stage, open-label study to determine efficacy of erlotinib and ruxolitinib. Patients will receive erlotinib and ruxolitinib at the MTD established in the phase I portion. The patient take their previous dose of erlotinib if it is less than 150mg daily.
10789332|NCT02787044|OG000|Outcome|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine"
10789333|NCT02787044|OG001|Outcome|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine"
10789334|NCT02787044|OG000|Outcome|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine; Note: primary analysis is of participant-seasons (n = 3577)"
10789335|NCT02787044|OG001|Outcome|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine; Note: primary analysis is of participant-seasons (n = 3577)"
10789336|NCT02787044|EG000|Reported Event|High Dose Influenza Vaccine|"High Dose Influenza Vaccine~High Dose Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine"
10789337|NCT02787044|EG001|Reported Event|Standard Dose Influenza Vaccine|"Standard Dose Influenza Vaccine~Standard Dose Quadrivalent Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine"
10789338|NCT02698163|BG000|Baseline|Gutta Percha|"For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10802411|NCT00653068|BG002|Baseline|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
10802412|NCT00653068|BG003|Baseline|Stratum IV|Older children with INI1 mutation only based diagnosis.
10802413|NCT00653068|BG004|Baseline|Total|Total of all reporting groups
10966651|NCT00887965|EG000|Reported Event|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
11382749|NCT02993757|EG001|Reported Event|CYD Dengue Vaccine + Gardasil (Sequential Administration)|Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Month 1 and Month 7. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the first 2 doses of CYD dengue vaccine.
11382750|NCT02992418|BG000|Baseline|CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.
11382751|NCT02992418|BG001|Baseline|CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.
11382752|NCT02992418|BG002|Baseline|Total|Total of all reporting groups
11382753|NCT02992418|FG000|Participant Flow|CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)|Participants received 1 booster dose of Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine 0.5 milliliter (mL) intramuscular (IM) injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL subcutaneous (SC) injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.
11382754|NCT02992418|FG001|Participant Flow|CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.
11382755|NCT02992418|OG000|Outcome|CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.
11382756|NCT02992418|OG001|Outcome|CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.
11382757|NCT02992418|EG000|Reported Event|CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.
11382758|NCT02992418|EG001|Reported Event|CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)|Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.
11382759|NCT02979535|BG000|Baseline|CYD Dengue Vaccine + Cervarix (Concomitant Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.
11382760|NCT02979535|BG001|Baseline|CYD Dengue Vaccine + Cervarix (Sequential Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
11382761|NCT02979535|BG002|Baseline|Total|Total of all reporting groups
11382762|NCT02979535|FG000|Participant Flow|CYD Dengue Vaccine + Cervarix (Concomitant Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.
11382763|NCT02979535|FG001|Participant Flow|CYD Dengue Vaccine + Cervarix (Sequential Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
11382764|NCT02979535|OG000|Outcome|CYD Dengue Vaccine + Cervarix (Concomitant Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.
11382765|NCT02979535|OG001|Outcome|CYD Dengue Vaccine + Cervarix (Sequential Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
11382766|NCT02979535|EG000|Reported Event|CYD Dengue Vaccine + Cervarix (Sequential Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.
11382767|NCT02979535|EG001|Reported Event|CYD Dengue Vaccine + Cervarix (Concomitant Administration)|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
11382768|NCT02978716|BG000|Baseline|Group 1: Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382769|NCT02978716|BG001|Baseline|Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382770|NCT02978716|BG002|Baseline|Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)|Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382771|NCT02978716|BG003|Baseline|Total|Total of all reporting groups
10789339|NCT02698163|BG001|Baseline|Nanodiamond Reinforced Gutta Percha|"For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789340|NCT02698163|BG002|Baseline|Total|Total of all reporting groups
10789341|NCT02698163|FG000|Participant Flow|Gutta Percha|"For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth. One tooth per participant was treated.~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789342|NCT02698163|FG001|Participant Flow|Nanodiamond Reinforced Gutta Percha|"For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls). One tooth per participant was treated."
10789343|NCT02698163|OG000|Outcome|Gutta Percha|"For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789344|NCT02698163|OG001|Outcome|Nanodiamond Reinforced Gutta Percha|"For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789345|NCT02698163|EG000|Reported Event|Gutta Percha|"For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789346|NCT02698163|EG001|Reported Event|Nanodiamond Reinforced Gutta Percha|"For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.~Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).~Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls)."
10789347|NCT02586675|BG000|Baseline|Tamoxifen and Ribociclib With Goserelin|Phase I dose escalation followed by Phase Ib dose expansion.
10966652|NCT00887978|BG000|Baseline|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
11241145|NCT02484807|FG005|Participant Flow|Macitentan + Tadalafil|"Combination treatment with Macitentan + Tadalafil at baseline~no intervention, only observation of different groups"
11241146|NCT02484807|OG000|Outcome|Bosentan + Sildenafil|"Combination treatment with Bosentan + Sildenafil at baseline~no intervention, only observation of different groups"
11241147|NCT02484807|OG001|Outcome|Bosentan + Tadalafil|"Combination treatment with Bosentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789348|NCT02586675|FG000|Participant Flow|Tamoxifen and Ribociclib With Goserelin|"Phase I dose escalation followed by Phase Ib dose expansion. Tamoxifen and Ribociclib, with Goserelin added for premenopausal or peri-menopausal participants. Ribociclib: Capsules/Tablets for oral use 400 mg OR 600 mg Days 1-21 of each 28 day cycle or daily. Tamoxifen: Tablets for oral use 20 mg daily (all days of every cycle without interruption). Goserelin: Subcutaneous injection 3.6 mg Day 1 of each 28 day cycle.~Tamoxifen: Tamoxifen will be taken orally once daily on a continuous daily schedule (e.g., days 1-28 of each 28 day cycle).~Ribociclib: Ribociclib (LEE011) will be taken orally once daily on days 1-21 of each 28 day cycle. Days 22-28 will be a rest period from dosing with Ribociclib. In the continuous cohort, 400 mg ribociclib will be given daily (QD).~Goserelin: Goserelin will be given as an injectable subcutaneous implant on day 1 of every 28 day cycle. This will be given in pre-menopausal and peri-menopausal women."
10789349|NCT02586675|OG000|Outcome|Tamoxifen and Ribociclib With Goserelin|Phase I dose escalation followed by Phase Ib dose expansion.
10789350|NCT02586675|EG000|Reported Event|Tamoxifen and Ribociclib With Goserelin|All participants were enrolled and treated on Cohort 1 (Ribociclib 400 mg PO D1-21; Tamoxifen 20 mg PO QD (1) only.
10789351|NCT02367105|BG000|Baseline|Placebo + Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789352|NCT02367105|BG001|Baseline|Testosterone + Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10789353|NCT02367105|BG002|Baseline|Total|Total of all reporting groups
10789354|NCT02367105|FG000|Participant Flow|Placebo + Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789355|NCT02367105|FG001|Participant Flow|Testosterone + Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10789356|NCT02367105|OG000|Outcome|Placebo + Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789357|NCT02367105|OG001|Outcome|Testosterone + Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10789358|NCT02367105|OG000|Outcome|Placebo Plus Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789359|NCT02367105|OG001|Outcome|Testosterone Plus Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10966653|NCT00887978|BG001|Baseline|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
10789360|NCT02367105|OG000|Outcome|Testosterone Plus Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10789361|NCT02367105|OG001|Outcome|Placebo Plus Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789362|NCT02367105|OG000|Outcome|Testosterone + Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
10789363|NCT02367105|OG001|Outcome|Placebo + Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10789364|NCT02367105|EG000|Reported Event|Placebo + Lifestyle Therapy|"Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone"
10966654|NCT00887978|BG002|Baseline|Total|Total of all reporting groups
10966655|NCT00887978|FG000|Participant Flow|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
10966656|NCT00887978|FG001|Participant Flow|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
10966657|NCT00887978|OG000|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
10965742|NCT00883558|BG000|Baseline|All Randomized Participants|"Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump."
10965743|NCT00883558|FG000|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a 1-month dose titration period.~Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
10966658|NCT00887978|OG001|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
10966659|NCT00887978|EG000|Reported Event|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1 (1.9).
10966660|NCT00887978|EG001|Reported Event|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1 (3.6).
11241148|NCT02484807|OG002|Outcome|Ambrisentan + Sildenafil|"Combination treatment with Ambrisentan + Sildenafil at baseline~no intervention, only observation of different groups"
11382772|NCT02978716|FG000|Participant Flow|Group 1: Gemcitabine/Carboplatin (Days 1 and 8)|Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382773|NCT02978716|FG001|Participant Flow|Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382774|NCT02978716|FG002|Participant Flow|Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)|Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382775|NCT02978716|OG000|Outcome|Group 1: Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382776|NCT02978716|OG001|Outcome|Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382777|NCT02978716|OG002|Outcome|Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)|Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382778|NCT02978716|OG000|Outcome|Group 1: Gemcitabine/Carboplatin (Day 1 and 8)|Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382779|NCT02978716|OG000|Outcome|Group 1: Gemcitabine/Carboplatin (Days 1 and 8)|Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382780|NCT02978716|EG000|Reported Event|Group 1: Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
11382781|NCT02978716|EG001|Reported Event|Group 2: Trilaciclib (G1T28)+ Gemcitabine/Carboplatin (Days 1 and 8)|Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382782|NCT02978716|EG002|Reported Event|Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)|Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
11382783|NCT02973321|BG000|Baseline|Placebo|Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
11382784|NCT02973321|BG001|Baseline|SAR425899 0.12 mg|SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
11382785|NCT02973321|BG002|Baseline|SAR425899 0.16 mg|SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
11382786|NCT02973321|BG003|Baseline|SAR425899 0.20 mg|SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
11382787|NCT02973321|BG004|Baseline|Liraglutide|Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
11382788|NCT02973321|BG005|Baseline|Total|Total of all reporting groups
11382789|NCT02973321|FG000|Participant Flow|Placebo|Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
11194956|NCT02155465|OG000|Outcome|Ruxolitinib and Erlotinib|"Phase I The study will follow a standard 3+3 dose escalation trial design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (21 days) before a dose escalation decision is made.~Phase II Once the MTD has been determined, patients will be enrolled in the phase 2 portion of the single-arm, two-stage, open-label study to determine efficacy of erlotinib and ruxolitinib. Patients will receive erlotinib and ruxolitinib at the MTD established in the phase I portion. The patient take their previous dose of erlotinib if it is less than 150mg daily."
11194957|NCT02155465|OG000|Outcome|Phase 1: Level 1|10mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194958|NCT02155465|OG001|Outcome|Phase 1: Level 2|15mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194959|NCT02155465|OG002|Outcome|Phase 1: Level 3|20mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194960|NCT02155465|OG003|Outcome|Phase 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD|20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD
11382790|NCT02973321|FG001|Participant Flow|SAR425899 0.12 mg|SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
10789365|NCT02367105|EG001|Reported Event|Testosterone + Lifestyle Therapy|"Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week"
11194961|NCT02155465|OG004|Outcome|Phase 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd
11194962|NCT02155465|OG005|Outcome|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd
11382791|NCT02973321|FG002|Participant Flow|SAR425899 0.16 mg|SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
11382792|NCT02973321|FG003|Participant Flow|SAR425899 0.20 mg|SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
10803872|NCT01410890|EG000|Reported Event|Alglucosidase Alfa: <18 Years|Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
11194963|NCT02155465|OG006|Outcome|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd
11194964|NCT02155465|EG000|Reported Event|Phase 1: Level 1|10mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194965|NCT02155465|EG001|Reported Event|Phase 1: Level 2|15mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194966|NCT02155465|EG002|Reported Event|Phase 1: Level 3|20mg Ruxolitinib PO bid/ 150mg PO qd Erlotinib
11194967|NCT02155465|EG003|Reported Event|PHASE 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD|20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD
11194968|NCT02155465|EG004|Reported Event|PHASE 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd
11194969|NCT02155465|EG005|Reported Event|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd
11194970|NCT02155465|EG006|Reported Event|PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd|20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd
11194971|NCT02155543|BG000|Baseline|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11194972|NCT02155543|BG001|Baseline|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11194973|NCT02155543|BG002|Baseline|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
11382793|NCT02973321|FG004|Participant Flow|Liraglutide|Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
11382794|NCT02973321|OG000|Outcome|Placebo|Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
11382795|NCT02973321|OG001|Outcome|SAR425899 0.12 mg|SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
11382796|NCT02973321|OG002|Outcome|SAR425899 0.16 mg|SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
11382797|NCT02973321|OG003|Outcome|SAR425899 0.20 mg|SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
11382798|NCT02973321|OG004|Outcome|Liraglutide|Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
11382799|NCT02973321|EG000|Reported Event|Placebo|Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
11382800|NCT02973321|EG001|Reported Event|SAR425899 0.06 mg|Participants who were originally randomized to SAR425899 treatment groups and received 0.06 mg QD at Week 8.
11382801|NCT02973321|EG002|Reported Event|SAR425899 0.12 mg|Participants who were originally randomized to SAR425899 treatment groups and received 0.12 mg QD at Week 8, or participants randomized to SAR425899 0.12 mg treatment group and discontinued the study before Week 8.
11382802|NCT02973321|EG003|Reported Event|SAR425899 0.16 mg|Participants who were originally randomized to SAR425899 treatment groups and received 0.16 mg QD at Week 8, or participants randomized to SAR425899 0.16 mg treatment group and discontinued the study before Week 8.
10789366|NCT01816165|BG000|Baseline|All Participants With T1 Diabetes|"Acipimox, Then Placebo: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.~Placebo, then Acipimox :Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789367|NCT01816165|BG001|Baseline|All Participants Without T1 Diabetes|"Placebo, then Acipimox :Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.~Acipimox, Then Placebo: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789368|NCT01816165|BG002|Baseline|Total|Total of all reporting groups
10789369|NCT01816165|FG000|Participant Flow|Participants With T1 Diabetes: Acipimox, Then Placebo|Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789370|NCT01816165|FG001|Participant Flow|Participants Without T1 Diabetes: Acipimox, Then Placebo|Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789371|NCT01816165|FG002|Participant Flow|Participants With T1 Diabetes: Placebo, Then Acipimox|Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789372|NCT01816165|FG003|Participant Flow|Participants Without T1 Diabetes: Placebo, Then Acipimox|Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day, followed by acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789373|NCT01816165|OG000|Outcome|T1 Diabetes, Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789374|NCT01816165|OG001|Outcome|T1 Diabetes, Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
11194974|NCT02155543|BG003|Baseline|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
10789375|NCT01816165|OG002|Outcome|No T1 Diabetes, Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789376|NCT01816165|OG003|Outcome|No T1 Diabetes, Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789377|NCT01816165|OG000|Outcome|T1 Diabetes, Acipimox|Drug: acipimox Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789378|NCT01816165|OG001|Outcome|T1 Diabetes, Placebo|Drug: Placebo Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day
10789379|NCT01816165|OG002|Outcome|No T1 Diabetes, Acipimox|Drug: acipimox Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
10789380|NCT01816165|OG003|Outcome|No T1 Diabetes, Placebo|Drug: Placebo Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day
10789381|NCT01816165|OG000|Outcome|T1D: Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789382|NCT01816165|OG001|Outcome|T1D: Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789383|NCT01816165|OG002|Outcome|No T1D: Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789384|NCT01816165|OG003|Outcome|No T1D: Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789385|NCT01816165|OG000|Outcome|Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789386|NCT01816165|OG001|Outcome|Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789387|NCT01816165|EG000|Reported Event|T1 Diabetes, Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789388|NCT01816165|EG001|Reported Event|T1 Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789389|NCT01816165|EG002|Reported Event|No T1 Diabetes, Acipimox|"Drug: acipimox~Acipimox: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day."
10789390|NCT01816165|EG003|Reported Event|No T1 Placebo|"Drug: Placebo~Placebo: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day"
10789391|NCT01813929|BG000|Baseline|Metformin, Then Placebo|"Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.~Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention."
10789392|NCT01813929|BG001|Baseline|Placebo, Then Metformin|"Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.~Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily."
10789393|NCT01813929|BG002|Baseline|Total|Total of all reporting groups
10789394|NCT01813929|FG000|Participant Flow|Metformin, Then Placebo|"Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.~Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention."
10789395|NCT01813929|FG001|Participant Flow|Placebo, Then Metformin|"Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.~Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily."
10789396|NCT01813929|OG000|Outcome|Metformin|Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.
10789397|NCT01813929|OG001|Outcome|Placebo|Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.
10789398|NCT01813929|EG000|Reported Event|Metformin|Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.
10789399|NCT01813929|EG001|Reported Event|Placebo|Placebo: Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.
10789400|NCT01502085|BG000|Baseline|Vorinostat, Lenalinomide, Dexamethasone|"Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above~Vorinostat, Lenalinomide and Dexamethasone: Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21~* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert~Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above"
10789401|NCT01502085|FG000|Participant Flow|Vorinostat, Lenalinomide, Dexamethasone|"Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above~Vorinostat, Lenalinomide and Dexamethasone: Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21~* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert~Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above"
10789402|NCT01502085|OG000|Outcome|Vorinostat, Lenalinomide, Dexamethasone|"Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above~Vorinostat, Lenalinomide and Dexamethasone: Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21~* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert~Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above"
11194975|NCT02155543|BG004|Baseline|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
11194976|NCT02155543|BG005|Baseline|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
11194977|NCT02155543|BG006|Baseline|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
11194978|NCT02155543|BG007|Baseline|Total|Total of all reporting groups
11241149|NCT02484807|OG003|Outcome|Ambrisentan + Tadalafil|"Combination treatment with Ambrisentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789403|NCT01502085|EG000|Reported Event|Vorinostat, Lenalinomide, Dexamethasone|"Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above~Vorinostat, Lenalinomide and Dexamethasone: Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21~* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert~Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above"
10789404|NCT01178814|BG000|Baseline|Revlimid|"Revlimid (Lenalidomide) capsule taken orally once a day~Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks."
10789405|NCT01178814|FG000|Participant Flow|Revlimid|"Revlimid (Lenalidomide) capsule taken orally once a day~Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks."
10789406|NCT01178814|OG000|Outcome|Revlimid|"Revlimid (Lenalidomide) capsule taken orally once a day~Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks."
10789407|NCT01178814|EG000|Reported Event|Revlimid|"Revlimid (Lenalidomide) capsule taken orally once a day~Revlimid (Lenalidomide): The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks."
10789408|NCT01125176|BG000|Baseline|All Subjects|"In Cycle -1, even numbered patients will receive oral lenalidomide daily on days 1-14 and then no treatment on days 15-28.~In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by no treatment on days 15-28.~Starting with cycle 1, all patients will alternate daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28. Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every 6th cycle thereafter (cycles 7, 13, 19, etc.)~Thalidomide: 50 mg oral dosing every other day~Lenalidomide: varying oral doses every other day (max 25 mg/day)~Rituximab: 375 mg/m2 intravenously on days 1, 8, 15, and 22 of cycle 1. Then, repeated on days 1, 8, 15, and 22 of every 6th cycle thereafter (Cycle 7, 13, 19, etc.)"
10789409|NCT01125176|FG000|Participant Flow|All Subjects|"In Cycle -1, even numbered patients will receive oral lenalidomide daily on days 1-14 and then no treatment on days 15-28.~In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by no treatment on days 15-28.~Starting with cycle 1, all patients will alternate daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28. Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every 6th cycle thereafter (cycles 7, 13, 19, etc.)~Thalidomide: 50 mg oral dosing every other day~Lenalidomide: varying oral doses every other day (max 25 mg/day)~Rituximab: 375 mg/m2 intravenously on days 1, 8, 15, and 22 of cycle 1. Then, repeated on days 1, 8, 15, and 22 of every 6th cycle thereafter (Cycle 7, 13, 19, etc.)"
10789410|NCT01125176|OG000|Outcome|All Subjects|"In Cycle -1, even numbered patients will receive oral lenalidomide daily on days 1-14 and then no treatment on days 15-28.~In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by no treatment on days 15-28.~Starting with cycle 1, all patients will alternate daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28. Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every 6th cycle thereafter (cycles 7, 13, 19, etc.)~Thalidomide: 50 mg oral dosing every other day~Lenalidomide: varying oral doses every other day (max 25 mg/day)~Rituximab: 375 mg/m2 intravenously on days 1, 8, 15, and 22 of cycle 1. Then, repeated on days 1, 8, 15, and 22 of every 6th cycle thereafter (Cycle 7, 13, 19, etc.)"
10789411|NCT01125176|EG000|Reported Event|All Subjects|"In Cycle -1, even numbered patients will receive oral lenalidomide daily on days 1-14 and then no treatment on days 15-28.~In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by no treatment on days 15-28.~Starting with cycle 1, all patients will alternate daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28. Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every 6th cycle thereafter (cycles 7, 13, 19, etc.)~Thalidomide: 50 mg oral dosing every other day~Lenalidomide: varying oral doses every other day (max 25 mg/day)~Rituximab: 375 mg/m2 intravenously on days 1, 8, 15, and 22 of cycle 1. Then, repeated on days 1, 8, 15, and 22 of every 6th cycle thereafter (Cycle 7, 13, 19, etc.)"
10789412|NCT00882050|BG000|Baseline|Exentatide 0.27 ng/kg/Min|"Demographics Exen 0.27 ng/kg/min~Sex: Female 9 Male 23 Age , mean (SD) 64.1 (13.41) Race: African American: 2 Caucasian: 30 Ethnicity: Non-Hispanic 32"
10789413|NCT00882050|BG001|Baseline|Exentatide 0.41 ng/kg/Min|"Table 1: Demographics Exen 0.41 ng/kg/min~Sex: Female 13 Male 20 Age , mean (SD) 67.4 (11.98) Race: African American: 2 Caucasian: 31 Ethnicity: Non-Hispanic 33"
10789414|NCT00882050|BG002|Baseline|Placebo of IV NSS|Table 1: Demographics placebo Sex: Female 11 Male 28 Age, mean (SD) 66.2 (13.56) Race: African American: 5 Caucasian: 34 Ethnicity: Non-Hispanic 39
10789415|NCT00882050|BG003|Baseline|Total|Total of all reporting groups
10789416|NCT00882050|FG000|Participant Flow|Exentatide 0.27 ng/kg/Min|"Exenatide IV 0.27 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. Induction of anesthesia will be equal to intubation time and drug will start (+ or-3 min).~Blood will be collected prior to intubation and then 10 and 30 min after drug initiation and every 30 min (+or-2 min) until the IV is stopped and/or at extubation. Sample collection every 30 min post extubation for 2 hours, and once at 24 hours after extubation.~Analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA) will be conducted."
11194979|NCT02155543|FG000|Participant Flow|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11194980|NCT02155543|FG001|Participant Flow|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
10789417|NCT00882050|FG001|Participant Flow|Exentatide 0.41 ng/kg/Min|"Experimental: IV Exenatide to be infused by intravenous method at 0.41 ng/kg/min (0.099 pmol/kg/min) over 3 to 6 hours.~Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes).~Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation.~Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin,Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA)."
10789418|NCT00882050|FG002|Participant Flow|Placebo IV NSS|"Placebo of IV normal saline solution as comparator.~Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes).~Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation.~Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA)."
10789419|NCT00882050|OG000|Outcome|Exentatide 0.27 ng/kg/Min|Experimental: IV Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.099 pmol/kg/min) over 3 to 6 hours. Minimum time of infusion 90 minutes.
10789420|NCT00882050|OG001|Outcome|Exenatide 0.41ng/kg/Min|Experimental: IV Exenatide to be infused by intravenous method at 0.41 ng/kg/min (0.099 pmol/kg/min) over 3 to 6 hours. Minimum time of infusion 90 minutes.
10789421|NCT00882050|OG002|Outcome|Placebo IV NSS|Placebo: IV NSS to be infused by intravenous method at rate for experimental drug over 3 to 6 hours. Minimum 90 minutes.
10789422|NCT00882050|EG000|Reported Event|Exentatide 0.27 ng/kg/Min|Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. Minimum 90 minutes post infusion.
10789423|NCT00882050|EG001|Reported Event|Exenatide 0.41ng/kg/Min|Exenatide to be infused by intravenous method at 0.41 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. Minimum 90 minutes post infusion.
10789424|NCT00882050|EG002|Reported Event|Placebo IV NSS|Placebo IV NSS to be at the rate of the experimental groups over 3-6 hours. Minimum 90 minutes post infusion.
10789425|NCT00070564|BG000|Baseline|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789426|NCT00070564|BG001|Baseline|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789427|NCT00070564|BG002|Baseline|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789428|NCT00070564|BG003|Baseline|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789429|NCT00070564|BG004|Baseline|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
10789430|NCT00070564|BG005|Baseline|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
10789431|NCT00070564|BG006|Baseline|Total|Total of all reporting groups
10789432|NCT00070564|FG000|Participant Flow|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10966661|NCT00888134|BG000|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11194981|NCT02155543|FG002|Participant Flow|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
11194982|NCT02155543|FG003|Participant Flow|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
10789433|NCT00070564|FG001|Participant Flow|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789434|NCT00070564|FG002|Participant Flow|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789435|NCT00070564|FG003|Participant Flow|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789436|NCT00070564|FG004|Participant Flow|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
10789437|NCT00070564|FG005|Participant Flow|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
10789438|NCT00070564|OG000|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789439|NCT00070564|OG001|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789440|NCT00070564|OG002|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789441|NCT00070564|OG003|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
10789442|NCT00070564|OG004|Outcome|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
10789443|NCT00070564|OG005|Outcome|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
11241150|NCT02484807|OG004|Outcome|Macitentan + Sildenafil|"Combination treatment with Macitentan + Sildenafil at baseline~no intervention, only observation of different groups"
10789444|NCT00070564|OG000|Outcome|ARM I|(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
10789445|NCT00070564|OG001|Outcome|ARM II|(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
10789446|NCT00070564|OG002|Outcome|ARM III|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
10789447|NCT00070564|OG003|Outcome|ARM IV|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
10789448|NCT00070564|OG004|Outcome|ARM V|"Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
10789449|NCT00070564|OG005|Outcome|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
10789450|NCT00070564|EG000|Reported Event|ARM I|(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
10789451|NCT00070564|EG001|Reported Event|ARM II|(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
10789452|NCT00070564|EG002|Reported Event|ARM III|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
10789453|NCT00070564|EG003|Reported Event|ARM IV|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
10789454|NCT00070564|EG004|Reported Event|ARM V|"Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
10789455|NCT00070564|EG005|Reported Event|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
10802414|NCT00653068|FG000|Participant Flow|Treatment|"Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.~Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity."
10802415|NCT00653068|OG000|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
10802416|NCT00653068|OG001|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
10802417|NCT00653068|OG000|Outcome|All Patients|Experimental
10802418|NCT00653068|EG000|Reported Event|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
10802419|NCT00653068|EG001|Reported Event|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
10802420|NCT00193479|BG000|Baseline|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
10802421|NCT00193479|FG000|Participant Flow|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
10802422|NCT00193479|OG000|Outcome|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
11194983|NCT02155543|FG004|Participant Flow|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
10802423|NCT00193479|EG000|Reported Event|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
10802424|NCT00193427|BG000|Baseline|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
10802425|NCT00193427|FG000|Participant Flow|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
10789456|NCT05167370|BG000|Baseline|Amifostine|Amifostine: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
10789457|NCT05167370|FG000|Participant Flow|Amifostine|Amifostine: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
10789458|NCT05167370|OG000|Outcome|Amifostine|Amifostine: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
10789459|NCT05167370|EG000|Reported Event|Amifostine|Amifostine: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
10789460|NCT04500821|BG000|Baseline|Activator LFD-2100|Lipiflow treatment with Activator LFD-2100
10789461|NCT04500821|FG000|Participant Flow|Activator LFD-2100|Lipiflow treatment with Activator LFD-2100
10789462|NCT04500821|OG000|Outcome|Activator LFD-2100|LipiFlow treatment with Activator LFD-2100
10789463|NCT04500821|EG000|Reported Event|Right Eye (OD)|LipiFlow treatment with Activator LFD-2100
10789464|NCT04500821|EG001|Reported Event|Left Eye (OS)|LipiFlow treatment with Activator LFD-2100
10789465|NCT04425720|BG000|Baseline|Standard Of Care|"Patients without wearable monitoring technology undergoing routine standard of care at the hospital.~Standard of Care: This group will be treated based on standard of care at our institution."
10789466|NCT04425720|BG001|Baseline|Monitored|"Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary~LifeSignals Biosensor 1AX*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter."
10965744|NCT00883558|FG001|Participant Flow|INSULIN-PH20 NP First, Then Insulin Lispro|"Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
10966662|NCT00888134|FG000|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11241151|NCT02484807|OG005|Outcome|Macitentan + Tadalafil|"Combination treatment with Macitentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789467|NCT04425720|BG002|Baseline|Total|Total of all reporting groups
10789468|NCT04425720|FG000|Participant Flow|Standard Of Care|"Patients without wearable monitoring technology undergoing routine standard of care at the hospital.~Standard of Care: This group will be treated based on standard of care at our institution."
10789469|NCT04425720|FG001|Participant Flow|Monitored|"Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary~LifeSignals Biosensor 1AX*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter."
10789470|NCT04425720|OG000|Outcome|Standard Of Care|"Patients without wearable monitoring technology undergoing routine standard of care at the hospital.~Standard of Care: This group will be treated based on standard of care at our institution."
10789471|NCT04425720|OG001|Outcome|Monitored|"Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary~LifeSignals Biosensor 1AX*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter."
10789472|NCT04425720|OG000|Outcome|Monitored|"Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary~LifeSignals Biosensor 1AX*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter."
10789473|NCT04425720|EG000|Reported Event|Standard Of Care|"Patients without wearable monitoring technology undergoing routine standard of care at the hospital.~Standard of Care: This group will be treated based on standard of care at our institution."
10789474|NCT04425720|EG001|Reported Event|Monitored|"Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary~LifeSignals Biosensor 1AX*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter."
10789475|NCT04409509|BG000|Baseline|Placebo|"CSL312 diluent administered intravenously~Placebo: CSL312 diluent administered intravenously"
10789476|NCT04409509|BG001|Baseline|CSL312|"Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously~Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously"
10789477|NCT04409509|BG002|Baseline|Total|Total of all reporting groups
10789478|NCT04409509|FG000|Participant Flow|Placebo|"CSL312 diluent administered intravenously~Placebo: CSL312 diluent administered intravenously"
11194984|NCT02155543|FG005|Participant Flow|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
10789479|NCT04409509|FG001|Participant Flow|CSL312|"Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously~Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously"
10789480|NCT04409509|OG000|Outcome|Placebo|"CSL312 diluent administered intravenously~Placebo: CSL312 diluent administered intravenously"
11194985|NCT02155543|FG006|Participant Flow|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
11194986|NCT02155543|OG000|Outcome|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11382803|NCT02973321|EG004|Reported Event|SAR425899 0.20 mg|Participants who were originally randomized to SAR425899 treatment groups and received 0.20 mg QD at Week 8, or participants randomized to SAR425899 0.20 mg treatment group and discontinued the study before Week 8.
11382804|NCT02973321|EG005|Reported Event|Liraglutide|Participants randomized to and received Liraglutide treatment were included in the Liraglutide treatment arm regardless of dose amount participants received.
11382805|NCT02943785|BG000|Baseline|Edoxaban|Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
11382806|NCT02943785|BG001|Baseline|Vitamin K Antagonist (VKA)|Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.
11382807|NCT02943785|BG002|Baseline|Total|Total of all reporting groups
11382808|NCT02943785|FG000|Participant Flow|Edoxaban|Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
11382809|NCT02943785|FG001|Participant Flow|Vitamin K Antagonist (VKA)|Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.
11382810|NCT02943785|OG000|Outcome|Edoxaban|Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
11382811|NCT02943785|OG001|Outcome|Vitamin K Antagonist (VKA)|Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.
11382812|NCT02943785|EG000|Reported Event|Edoxaban|Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
11382813|NCT02943785|EG001|Reported Event|Vitamin K Antagonist (VKA)|Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.
10789481|NCT04409509|OG001|Outcome|CSL312|"Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously~Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously"
10789482|NCT04409509|OG000|Outcome|CSL312|"Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously~Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously"
10789483|NCT04409509|EG000|Reported Event|Placebo|"CSL312 diluent administered intravenously~Placebo: CSL312 diluent administered intravenously"
10789484|NCT04409509|EG001|Reported Event|CSL312|"Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously~Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously"
10789485|NCT04380519|BG000|Baseline|RPH -104 80 mg|Subcutaneous single injection of RPH-104 80 mg (2 ml 40 mg/mL solution) on Day 1, in addition to standard therapy.
10789486|NCT04380519|BG001|Baseline|Olokizumab 64 mg|Subcutaneous single injection of Olokizumab 64 mg (0,4 ml 160 mg/mL solution) on Day 1, in addition to standard therapy.
10789487|NCT04380519|BG002|Baseline|Placebo|Subcutaneous single injection of 2 ml solution of Placebo (Normal Saline) on Day 1, in addition to standard therapy.
10789488|NCT04380519|BG003|Baseline|Total|Total of all reporting groups
10789489|NCT04380519|FG000|Participant Flow|RPH -104 80 mg|Subcutaneous single injection of RPH-104 80 mg (2 ml 40 mg/mL solution) on Day 1, in addition to standard therapy.
10789490|NCT04380519|FG001|Participant Flow|Olokizumab 64 mg|Subcutaneous single injection of Olokizumab 64 mg (0,4 ml 160 mg/mL solution) on Day 1, in addition to standard therapy.
10789491|NCT04380519|FG002|Participant Flow|Placebo|Subcutaneous single injection of 2 ml solution of Placebo (Normal Saline) on Day 1, in addition to standard therapy.
10789492|NCT04380519|OG000|Outcome|RPH -104 80 mg|Subcutaneous single injection of RPH-104 80 mg (2 ml 40 mg/mL solution) on Day 1, in addition to standard therapy.
10789493|NCT04380519|OG001|Outcome|Olokizumab 64 mg|Subcutaneous single injection of Olokizumab 64 mg (0,4 ml 160 mg/mL solution) on Day 1, in addition to standard therapy.
10789494|NCT04380519|OG002|Outcome|Placebo|Subcutaneous single injection of 2 ml solution of Placebo (Normal Saline) on Day 1, in addition to standard therapy.
10789495|NCT04380519|EG000|Reported Event|RPH -104 80 mg|"Subject randomized to receive subcutaneous single injection of 2 ml solution of RPH-104 on Day 1, in addition to standard therapy~RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial"
10789496|NCT04380519|EG001|Reported Event|Olokizumab 64 mg|"Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Olokizumab on Day 1, in addition to standard therapy~Olokizumab 64 mg: solution for subcutaneous administration 160 mg/mL, in the 2-mL glass vial (target volume 0,4 ml)"
10789497|NCT04380519|EG002|Reported Event|Placebo|"Subject randomized to receive subcutaneous single injection of 2 ml solution of Placebo on Day 1, in addition to standard therapy~Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package"
10802426|NCT00193427|OG000|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
10802427|NCT00193427|OG000|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered.
11194987|NCT02155543|OG001|Outcome|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11194988|NCT02155543|OG002|Outcome|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
10802428|NCT00193427|EG000|Reported Event|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
10802429|NCT00193414|BG000|Baseline|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
10802430|NCT00193414|FG000|Participant Flow|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
10802431|NCT00193414|OG000|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
10802432|NCT00193414|EG000|Reported Event|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
10802433|NCT00085735|BG000|Baseline|Arm I (3-7 Years of Age, LDCSI, IFRT)|Eligible patients 3-7 yrs of age, LDCSI, IFRT
10802434|NCT00085735|BG001|Baseline|Arm II (3-7 Years of Age, LDCSI, PFRT)|Eligible patients 3-7 yrs of age, LDCSI, PFRT
10802435|NCT00085735|BG002|Baseline|Arm III (3-7 Years of Age, SDCSI, IFRT)|Eligible patients 3-7 yrs of age, SDCSI, IFRT
11194989|NCT02155543|OG003|Outcome|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
10789498|NCT04362813|BG000|Baseline|Canakinumab|Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789499|NCT04362813|BG001|Baseline|Placebo|250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789500|NCT04362813|BG002|Baseline|Total|Total of all reporting groups
10789501|NCT04362813|FG000|Participant Flow|Canakinumab|Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789502|NCT04362813|FG001|Participant Flow|Placebo|250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789503|NCT04362813|OG000|Outcome|Canakinumab|Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789504|NCT04362813|OG001|Outcome|Placebo|250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789505|NCT04362813|EG000|Reported Event|Canakinumab|Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789506|NCT04362813|EG001|Reported Event|Placebo|250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
10789507|NCT04231409|BG000|Baseline|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789508|NCT04231409|BG001|Baseline|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
11194990|NCT02155543|EG000|Reported Event|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
10789509|NCT04231409|BG002|Baseline|Total|Total of all reporting groups
10789510|NCT04231409|FG000|Participant Flow|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789511|NCT04231409|FG001|Participant Flow|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789512|NCT04231409|OG000|Outcome|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789513|NCT04231409|OG001|Outcome|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789514|NCT04231409|EG000|Reported Event|WaveWriter Settings|"WaveWriter Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789515|NCT04231409|EG001|Reported Event|Conventional Settings|"Conventional Programming~Boston Scientific Spectra WaveWriter SCS System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain."
10789516|NCT04136548|BG000|Baseline|All Participants|All participants
10789517|NCT04136548|FG000|Participant Flow|Placebo, Then Fentanyl|Participants first received Placebo (75 ug) each (<5mins). After a washout period of lying down for resting for sometime , then Fentanyl (75 ug) is administered to each participant (<5 mins)
10789518|NCT04136548|FG001|Participant Flow|Fentanyl, Then Placebo|Participants first received Fentanyl (75 ug) visit. each (<5mins). After a washout period of lying down for resting for sometime , then Placebo (75 ug) is administered to each participant (<5 mins)
10789519|NCT04136548|OG000|Outcome|Fentanyl|"Fentanyl will be administered intravenously during one visit.~Fentanyl: Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed."
10789520|NCT04136548|OG001|Outcome|Placebo|"Placebo (saline) will be administered intravenously during one visit.~Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed."
10789521|NCT04136548|EG000|Reported Event|Placebo|Experimental visit with Placebo administration
11194991|NCT02155543|EG001|Reported Event|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
11194992|NCT02155543|EG002|Reported Event|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
10789522|NCT04136548|EG001|Reported Event|Fentanyl|Experimental visit with Fentanyl administration
10789523|NCT04126057|BG000|Baseline|DOT Spectacle Lenses Test|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789524|NCT04126057|BG001|Baseline|DOT Spectacle Lenses Control|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789525|NCT04126057|BG002|Baseline|Total|Total of all reporting groups
10789526|NCT04126057|FG000|Participant Flow|DOT Spectacle Lenses Test|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789527|NCT04126057|FG001|Participant Flow|DOT Spectacle Lenses Control|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789528|NCT04126057|OG000|Outcome|DOT Spectacle Lenses Using Test|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789529|NCT04126057|OG001|Outcome|DOT Spectacle Lenses Using Control|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789530|NCT04126057|EG000|Reported Event|DOT Spectacle Lenses Using Test|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789531|NCT04126057|EG001|Reported Event|DOT Spectacle Lenses Using Control|"Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B~SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes"
10789532|NCT04087395|BG000|Baseline|Split-face Study : Bilateral Treatment With RHA®4 With New Anesthetic Agent Vs RHA®4-Lidocaine|Split-face injection of RHA®4 with new anesthetic agent in the nasolabial folds on one side of the face and RHA®4-Lidocaine in the perioral rhytids on the opposite side of the face
11194993|NCT02155543|EG003|Reported Event|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
10789533|NCT04087395|FG000|Participant Flow|Split-face Study : Bilateral Treatment RHA® 4 With New Anesthetic Agent Vs RHA® 4-Lidocaine|"Split-face injection of RHA® 4 with new anesthetic agent in the NLF on one side of the face and RHA® 4- Lidocaine in the NLF on the opposite side of the face.~RHA® 4 with new anesthetic agent was administered in a random sequence (first or second injection) on one side and RHA®4-Lidocaine was administered in the side."
10789534|NCT04087395|OG000|Outcome|RHA®4 With New Anesthetic Agent|Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.
10789535|NCT04087395|OG001|Outcome|RHA®4-Lidocaine|Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.
10789536|NCT04087395|OG000|Outcome|RHA®4 With New Anesthetic Agent|"Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.~Up to 3 mL injected per side.~RHA®4 with new anesthetic agent: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer."
10789537|NCT04087395|OG001|Outcome|RHA®4-Lidocaine|"Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.~Up to 3 mL injected per side.~RHA®4-Lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer."
10789538|NCT04087395|EG000|Reported Event|RHA®4 With New Anesthetic Agent|Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.
10789539|NCT04087395|EG001|Reported Event|RHA®4-Lidocaine|Split-face injection of RHA®4 with new anesthetic agent in the nasolabial fold of one side of the face and RHA®4-Lidocaine in the nasolabial fold of opposite side of the face.
10789540|NCT04072432|BG000|Baseline|120 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789541|NCT04072432|BG001|Baseline|240 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789542|NCT04072432|BG002|Baseline|360 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789543|NCT04072432|BG003|Baseline|Total|Total of all reporting groups
10789544|NCT04072432|FG000|Participant Flow|120 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789545|NCT04072432|FG001|Participant Flow|240 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789546|NCT04072432|FG002|Participant Flow|360 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789547|NCT04072432|OG000|Outcome|120 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789548|NCT04072432|OG001|Outcome|240 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789549|NCT04072432|OG002|Outcome|360 mg RBT-3|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789550|NCT04072432|EG000|Reported Event|120 mg FeS|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789551|NCT04072432|EG001|Reported Event|240 mg FeS|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789552|NCT04072432|EG002|Reported Event|360 mg FeS|Single IV infusion in 3 healthy volunteers and 3 subjects with CKD Stage 3-4
10789553|NCT04069585|BG000|Baseline|Bilateral Treatment With RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine|Split-face injection of RHA® Redensity With New Anesthetic Agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids on the opposite side of the mouth.
10789554|NCT04069585|FG000|Participant Flow|Bilateral Treatment RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine|"Split-face injection of RHA® Redensity With New Anesthetic Agent in the perioral rhytids on one side of the mouth and RHA® Redensity with lidocaine in the perioral rhytids on the other side of the mouth.~RHA® Redensity With New Anesthetic Agent was administered in a random sequence (first or second injection) on one side of the mouth and RHA® Redensity with lidocaine was administered in the other side."
10789555|NCT04069585|OG000|Outcome|RHA® Redensity With Lidocaine|RHA® Redensity with lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
10789556|NCT04069585|OG001|Outcome|RHA® Redensity With New Anesthetic Agent|RHA® Redensity with new anesthetic agent A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w of a new anesthetic agent in a physiologic buffer.
10789557|NCT04069585|EG000|Reported Event|RHA® Redensity With New Anesthetic Agent|RHA® Redensity with new anesthetic agent A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w of a new anesthetic agent in a physiologic buffer.
10789558|NCT04069585|EG001|Reported Event|RHA® Redensity With Lidocaine|RHA® Redensity with lidocaine: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
10802436|NCT00085735|BG003|Baseline|Arm IV (3-7 Years of Age, SDCSI, PFRT)|Eligible patients 3-7 yrs of age, SDCSI, PFRT
11194994|NCT02155543|EG004|Reported Event|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
10802437|NCT00085735|BG004|Baseline|Arm V (8-21 Years of Age, SDCSI, IFRT)|Eligible patients 8-21 yrs of age, SDCSI, IFRT
10802438|NCT00085735|BG005|Baseline|Arm VI (8-21 Years of Age, SDCSI, PFRT)|Eligible patients 8-21 yrs of age, SDCSI, PFRT
10802439|NCT00085735|BG006|Baseline|Total|Total of all reporting groups
10802440|NCT00085735|FG000|Participant Flow|Arm I (3-7 Yrs of Age, LDCSI, IFRT)|Patients 3-7 years of age, LDCSI, IFRT
10802441|NCT00085735|FG001|Participant Flow|Arm II (3-7 Yrs of Age, LDCSI, PFRT)|Patients 3-7 years of age, LDCSI, PFRT
10802442|NCT00085735|FG002|Participant Flow|Arm III (3-7 Yrs of Age, SDCSI, IFRT)|Patients 3-7 years of age, SDCSI, IFRT
10802443|NCT00085735|FG003|Participant Flow|Arm IV (3-7 Yrs of Age, SDCSI, PFRT)|Patients 3-7 years of age, SDCSI, PFRT
10802444|NCT00085735|FG004|Participant Flow|Arm V (8-21 Yrs of Age, SDCSI, IFRT)|Patients 8-21 years of age, SDCSI, IFRT
10802445|NCT00085735|FG005|Participant Flow|Arm VI (8-21 Yrs of Age, SDCSI, PFRT)|Patients 8-21 yrs of age, SDCSI, PFRT
10802446|NCT00085735|OG000|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
10802447|NCT00085735|OG001|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
10802448|NCT00085735|OG002|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
10802449|NCT00085735|OG003|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
10802450|NCT00085735|OG000|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
10802451|NCT00085735|OG001|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
10802452|NCT00085735|OG002|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
10802453|NCT00085735|OG003|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
10802454|NCT00085735|OG000|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
10802455|NCT00085735|OG001|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
10789559|NCT03922321|BG000|Baseline|RVT-1401|Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 2 weeks, followed by a 340 mg SC injection weekly for 4 weeks.
10789560|NCT03922321|FG000|Participant Flow|RVT-1401|Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 2 weeks, followed by a 340 mg SC injection weekly for 4 weeks.
10789561|NCT03922321|OG000|Outcome|RVT-1401|Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 2 weeks, followed by a 340 mg SC injection weekly for 4 weeks.
10789562|NCT03922321|EG000|Reported Event|RVT-1401|Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 2 weeks, followed by a 340 mg SC injection weekly for 4 weeks.
10789563|NCT03911713|BG000|Baseline|Ivacaftor|Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.
10789564|NCT03911713|BG001|Baseline|VX-561: 25 mg|Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.
10789565|NCT03911713|BG002|Baseline|VX-561: 50 mg|Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
10789566|NCT03911713|BG003|Baseline|VX-561: 150 mg|Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
10789567|NCT03911713|BG004|Baseline|VX-561: 250 mg|Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
10789568|NCT03911713|BG005|Baseline|Total|Total of all reporting groups
10789569|NCT03911713|FG000|Participant Flow|Ivacaftor|Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.
10789570|NCT03911713|FG001|Participant Flow|VX-561: 25 mg|Participants received VX-561 25 mg orally once daily (qd) in the treatment period for 12 weeks.
10789571|NCT03911713|FG002|Participant Flow|VX-561: 50 mg|Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
10789572|NCT03911713|FG003|Participant Flow|VX-561: 150 mg|Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
10789573|NCT03911713|FG004|Participant Flow|VX-561: 250 mg|Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
10789574|NCT03911713|OG000|Outcome|Ivacaftor|Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.
10789575|NCT03911713|OG001|Outcome|VX-561: 150 mg|Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
10789576|NCT03911713|OG002|Outcome|VX-561: 250 mg|Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
10789577|NCT03911713|OG001|Outcome|VX-561: 25 mg|Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.
10789578|NCT03911713|OG002|Outcome|VX-561: 50 mg|Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
10789579|NCT03911713|OG003|Outcome|VX-561: 150 mg|Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
10789580|NCT03911713|OG004|Outcome|VX-561: 250 mg|Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
10789581|NCT03911713|EG000|Reported Event|Ivacaftor|Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.
10789582|NCT03911713|EG001|Reported Event|VX-561: 25 mg|Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.
11194995|NCT02155543|EG005|Reported Event|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
10789583|NCT03911713|EG002|Reported Event|VX-561: 50 mg|Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
10789584|NCT03911713|EG003|Reported Event|VX-561: 150 mg|Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
10789585|NCT03911713|EG004|Reported Event|VX-561: 250 mg|Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
10789586|NCT03879642|BG000|Baseline|REDCHiP|"10 week video-based telemedicine intervention to reduce parents hypoglycemia fear~REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear"
10789587|NCT03879642|BG001|Baseline|Waitlist|10 week no intervention to provide waitlist control condition
10789588|NCT03879642|BG002|Baseline|Total|Total of all reporting groups
10789589|NCT03879642|FG000|Participant Flow|REDCHiP|"10 week video-based telemedicine intervention to reduce parents hypoglycemia fear~REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear"
10789590|NCT03879642|FG001|Participant Flow|Waitlist|10 week no intervention to provide waitlist control condition
10789591|NCT03879642|OG000|Outcome|REDCHiP|"10 week video-based telemedicine intervention to reduce parents hypoglycemia fear~REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear"
10789592|NCT03879642|OG001|Outcome|Waitlist|10 week no intervention to provide waitlist control condition
10789593|NCT03879642|EG000|Reported Event|REDCHiP|"10 week video-based telemedicine intervention to reduce parents hypoglycemia fear~REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear"
10789594|NCT03879642|EG001|Reported Event|Waitlist|10 week no intervention to provide waitlist control condition
10789595|NCT03852459|BG000|Baseline|Active Arm|"S-Ibuprofen Topical Gel 5%~S-Ibuprofen: Topical Gel 5%"
10789596|NCT03852459|BG001|Baseline|Placebo Arm|"Vehicle Topical Gel~Vehicle: Vehicle Gel"
10789597|NCT03852459|BG002|Baseline|Total|Total of all reporting groups
10789598|NCT03852459|FG000|Participant Flow|Active Arm|"S-Ibuprofen Topical Gel 5%~AP0302 (S-ibuprofen topical gel 5%)applied up to 7 times in 24 hours, over a 48-hour dosing period."
10789599|NCT03852459|FG001|Participant Flow|Placebo Arm|"Vehicle Topical Gel~Placebo topical gel 5% applied up to 7 times in 24 hours, over a 48-hour dosing period."
10789600|NCT03852459|OG000|Outcome|Active Arm|"S-Ibuprofen Topical Gel 5%~S-Ibuprofen: Topical Gel 5%"
10789601|NCT03852459|OG001|Outcome|Placebo Arm|"Vehicle Topical Gel~Vehicle: Vehicle Gel"
10789602|NCT03852459|EG000|Reported Event|Active Arm|"S-Ibuprofen Topical Gel 5%~S-Ibuprofen: Topical Gel 5%"
10789603|NCT03852459|EG001|Reported Event|Placebo Arm|"Vehicle Topical Gel~Vehicle: Vehicle Gel"
11241152|NCT02484807|OG000|Outcome|Bosentan / Sildenafil Indicated for Therapy Switch|patients from bosentan/sildenafil group who showed unsatisfying clinical response to current therapy were switched from bosentan to macitentan. Plasma concentrations were controlled after change of ERA.
10789604|NCT03740919|BG000|Baseline|Insulin Lispro (Humalog)|Participants received 100 U/mL insulin lispro (Humalog) administered SC, 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
10789605|NCT03740919|BG001|Baseline|LY900014|Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
10789606|NCT03740919|BG002|Baseline|LY900014 Postmeal|Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
10789607|NCT03740919|BG003|Baseline|Total|Total of all reporting groups
10789608|NCT03740919|FG000|Participant Flow|Insulin Lispro (Humalog) Lead-in|Participants were switched to open-label insulin lispro (Humalog) administered subcutaneously (SC), using a unit for unit conversion or the dose could have been determined based on investigator's clinical judgement.
10789609|NCT03740919|FG001|Participant Flow|Insulin Lispro (Humalog)|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered SC, 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
10789610|NCT03740919|FG002|Participant Flow|LY900014|Participants received 100 U/mL LY900014 administered SC 0 to 2 minutes before start of the meal.
10789611|NCT03740919|FG003|Participant Flow|LY900014 Postmeal|Participants received 100 U/mL LY900014 administered SC up to 20 minutes after the start of the meal.
10789612|NCT03740919|OG000|Outcome|Insulin Lispro (Humalog)|Participants received 100 U/mL insulin lispro (Humalog) administered SC, 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets
10789613|NCT03740919|OG001|Outcome|LY900014|Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
10789614|NCT03740919|OG001|Outcome|LY900014 Postmeal|Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
10789615|NCT03740919|OG002|Outcome|LY900014 Postmeal|Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
10789616|NCT03740919|OG000|Outcome|Insulin Lispro (Humalog)|Participants received 100 U/mL insulin lispro (Humalog) administered SC, 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
10789617|NCT03740919|EG000|Reported Event|Humalog Lead-in|Participants received open-label insulin lispro (Humalog) administered subcutaneously (SC), using a unit for unit conversion or the dose was determined based on the investigator's clinical judgement.
10789618|NCT03740919|EG001|Reported Event|Humalog|Participants received 100 U/mL insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
10789619|NCT03740919|EG002|Reported Event|LY900014|Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
10789620|NCT03740919|EG003|Reported Event|LY900014 Postmeal|Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
10789621|NCT03700970|BG000|Baseline|Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.~Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side."
10789622|NCT03700970|BG001|Baseline|Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.~Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side."
10789623|NCT03700970|BG002|Baseline|Total|Total of all reporting groups
10789624|NCT03700970|FG000|Participant Flow|TAP Block With Liposomal Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.~Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side."
10789625|NCT03700970|FG001|Participant Flow|TAP Block With Regular Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.~Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side."
11241153|NCT02484807|EG000|Reported Event|Bosentan + Sildenafil|"Combination treatment with Bosentan + Sildenafil at baseline~no intervention, only observation of different groups"
10789626|NCT03700970|OG000|Outcome|Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.~Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side."
10789627|NCT03700970|OG001|Outcome|Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.~Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side."
10789628|NCT03700970|OG000|Outcome|TAP Block With Liposomal Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.~Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side."
10789629|NCT03700970|OG001|Outcome|TAP Block With Regular Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.~Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side."
10789630|NCT03700970|EG000|Reported Event|TAP Block With Liposomal Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.~Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side."
10789631|NCT03700970|EG001|Reported Event|TAP Block With Regular Bupivacaine|"Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.~Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side."
10789632|NCT03652454|BG000|Baseline|Micro-osteoperforation|"Propel device (ABD)~micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel device (ABD)~micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone."
10789633|NCT03652454|BG001|Baseline|Conventional Treatment|"conventional fixed appliance treatment~conventional fixed appliance treatment: conventional fixed appliance treatment conventional fixed appliance treatment~conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures."
10789634|NCT03652454|BG002|Baseline|Total|Total of all reporting groups
11194996|NCT02155543|EG006|Reported Event|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
10789635|NCT03652454|FG000|Participant Flow|Micro-osteoperforation|"Propel device (ABD)~micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone. The procedure was applied at the beginning of the study in the areas of crowding and not repeated."
10789636|NCT03652454|FG001|Participant Flow|Conventional Treatment|"conventional fixed appliance treatment~conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures."
10789637|NCT03652454|OG000|Outcome|Micro-osteoperforation|"Propel device (ABD)~micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon"
10789638|NCT03652454|OG001|Outcome|Conventional Treatment|"conventional fixed appliance treatment~conventional fixed appliance treatment: conventional fixed appliance treatment"
10789639|NCT03652454|EG000|Reported Event|Micro-osteoperforation|"Propel device (ABD)~micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon"
10789640|NCT03652454|EG001|Reported Event|Conventional Treatment|"conventional fixed appliance treatment~conventional fixed appliance treatment: conventional fixed appliance treatment"
10789641|NCT03647488|BG000|Baseline|Run-in Part: Capmatinib + Spartalizumab|Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789642|NCT03647488|BG001|Baseline|Randomized Part: Capmatinib + Spartalizumab|Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789643|NCT03647488|BG002|Baseline|Randomized Part: Docetaxel|Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
10789644|NCT03647488|BG003|Baseline|Total|Total of all reporting groups
10789645|NCT03647488|FG000|Participant Flow|Run-in Part: Capmatinib + Spartalizumab|Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789646|NCT03647488|FG001|Participant Flow|Randomized Part: Capmatinib + Spartalizumab|Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789647|NCT03647488|FG002|Participant Flow|Randomized Part: Docetaxel|Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
10789648|NCT03647488|OG000|Outcome|Run-in Part: Capmatinib + Spartalizumab|Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789649|NCT03647488|OG000|Outcome|Randomized Part: Capmatinib + Spartalizumab|Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789650|NCT03647488|OG001|Outcome|Randomized Part: Docetaxel|Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
10789651|NCT03647488|EG000|Reported Event|Run-in Part: Capmatinib + Spartalizumab|Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
10789652|NCT03614923|BG000|Baseline|Etokimab 300 mg + 150 mg Q4W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection Q4W up to Week 12 (Weeks 4, 8, and 12). Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789653|NCT03614923|BG001|Baseline|Etokimab 300 mg + 150 mg Q8W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection Q8W up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789654|NCT03614923|BG002|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789655|NCT03614923|BG003|Baseline|Total|Total of all reporting groups
10789656|NCT03614923|FG000|Participant Flow|Etokimab 300 mg + 150 mg Q4W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID).
10789657|NCT03614923|FG001|Participant Flow|Etokimab 300 mg + 150 mg Q8W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789658|NCT03614923|FG002|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
11241154|NCT02484807|EG001|Reported Event|Bosentan + Tadalafil|"Combination treatment with Bosentan + Tadalafil at baseline~no intervention, only observation of different groups"
10789659|NCT03614923|OG000|Outcome|Etokimab 300 mg + 150 mg Q4W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection Q4W up to Week 12 (Weeks 4, 8, and 12). Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789660|NCT03614923|OG001|Outcome|Etokimab 300 mg + 150 mg Q8W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection Q8W up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789661|NCT03614923|OG002|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789662|NCT03614923|EG000|Reported Event|Etokimab 300 mg + 150 mg Q4W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection Q4W up to Week 12 (Weeks 4, 8, and 12). Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789663|NCT03614923|EG001|Reported Event|Etokimab 300 mg + 150 mg Q8W|Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection Q8W up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789664|NCT03614923|EG002|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
10789665|NCT03502187|BG000|Baseline|Primary Care Management (PCM)|Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
10789666|NCT03502187|BG001|Baseline|NeuromuscularElectricalStimulation(NMES)|"NeuromuscularElectricalStimulation(NMES): The NMES treatment group received a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. It delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal).~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789667|NCT03502187|BG002|Baseline|Progressive Exercise Plan (PEP)|"Progressive Exercise Plan: The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789668|NCT03502187|BG003|Baseline|Total|Total of all reporting groups
10789669|NCT03502187|FG000|Participant Flow|Primary Care Management (PCM)|Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
10802456|NCT00085735|OG001|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
10802457|NCT00085735|OG000|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
10802458|NCT00085735|OG000|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.
10966663|NCT00888134|OG000|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
11194997|NCT02155608|BG000|Baseline|Active eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation.~Active eTNS: Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period."
11194998|NCT02155608|BG001|Baseline|Sham eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation.~Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period."
11194999|NCT02155608|BG002|Baseline|Total|Total of all reporting groups
11195000|NCT02155608|FG000|Participant Flow|Active TNS|"Active TNS~Active TNS: Participants randomized to active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
11195001|NCT02155608|FG001|Participant Flow|Sham TNS|"Sham TNS~Sham TNS: Participants randomized to sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
11195002|NCT02155608|OG000|Outcome|Active eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension.~Active eTNS: Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open active eTNS in a 12 month extension period."
11241155|NCT02484807|EG002|Reported Event|Ambrisentan + Sildenafil|"Combination treatment with Ambrisentan + Sildenafil at baseline~no intervention, only observation of different groups"
11241156|NCT02484807|EG003|Reported Event|Ambrisentan + Tadalafil|"Combination treatment with Ambrisentan + Tadalafil at baseline~no intervention, only observation of different groups"
11382814|NCT02923674|BG000|Baseline|Weight Loss + Exercise + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382815|NCT02923674|BG001|Baseline|Weight Loss + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382816|NCT02923674|BG002|Baseline|Weight Loss + Exercise|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week."
11382817|NCT02923674|BG003|Baseline|Total|Total of all reporting groups
11382818|NCT02923674|FG000|Participant Flow|Weight Loss + Exercise + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382819|NCT02923674|FG001|Participant Flow|Weight Loss + Exercise|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week."
10789670|NCT03502187|FG001|Participant Flow|NeuromuscularElectricalStimulation(NMES)|"NeuromuscularElectricalStimulation(NMES): The NMES treatment group received a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. It delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal).~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789671|NCT03502187|FG002|Participant Flow|Progressive Exercise Plan (PEP)|"Progressive Exercise Plan: The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789672|NCT03502187|OG000|Outcome|Primary Care Management (PCM)|Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
10789673|NCT03502187|OG001|Outcome|NeuromuscularElectricalStimulation(NMES)|"NeuromuscularElectricalStimulation(NMES): The NMES treatment group received a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. It delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal).~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789674|NCT03502187|OG002|Outcome|Progressive Exercise Plan (PEP)|"Progressive Exercise Plan: The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789675|NCT03502187|EG000|Reported Event|Primary Care Management (PCM)|Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
10966664|NCT00888134|OG000|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Selumetinib: Given PO"
10802459|NCT00085735|OG001|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.
11241157|NCT02484807|EG004|Reported Event|Macitentan + Sildenafil|"Combination treatment with Macitentan + Sildenafil at baseline~no intervention, only observation of different groups"
11241158|NCT02484807|EG005|Reported Event|Macitentan + Tadalafil|"Combination treatment with Macitentan + Tadalafil at baseline~no intervention, only observation of different groups"
11241159|NCT02484859|BG000|Baseline|Remifentanil|Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
11241160|NCT02484859|BG001|Baseline|Tramadol + Metoprolol|Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
11241161|NCT02484859|BG002|Baseline|Total|Total of all reporting groups
11241162|NCT02484859|FG000|Participant Flow|Remifentanil|Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
11241163|NCT02484859|FG001|Participant Flow|Tramadol + Metoprolol|Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
11241164|NCT02484859|OG000|Outcome|Remifentanil|Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
11241165|NCT02484859|OG001|Outcome|Tramadol + Metoprolol|Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
11241166|NCT02484859|OG000|Outcome|Remifentanil|"Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.~Remifentanil: Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated."
11241167|NCT02484859|OG001|Outcome|Tramadol + Metoprolol|"Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.~Tramadol: 1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.~Metoprolol: 0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent."
11241168|NCT02484859|EG000|Reported Event|Remifentanil|Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
11241169|NCT02484859|EG001|Reported Event|Tramadol + Metoprolol|Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
11241170|NCT02484898|BG000|Baseline|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
11241171|NCT02484898|FG000|Participant Flow|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
11241172|NCT02484898|OG000|Outcome|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
11241173|NCT02484898|EG000|Reported Event|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
11241174|NCT02484911|BG000|Baseline|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11382820|NCT02923674|FG002|Participant Flow|Weight Loss + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382821|NCT02923674|OG000|Outcome|Weight Loss + Exercise + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382822|NCT02923674|OG001|Outcome|Weight Loss + Exercise|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week."
11382823|NCT02923674|OG002|Outcome|Weight Loss + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382824|NCT02923674|EG000|Reported Event|Weight Loss + Exercise + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11382825|NCT02923674|EG001|Reported Event|Weight Loss + Sitless|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3)."
11241175|NCT02484911|BG001|Baseline|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11241176|NCT02484911|BG002|Baseline|Total|Total of all reporting groups
11382826|NCT02923674|EG002|Reported Event|Weight Loss + Exercise|"Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.~Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week."
11382827|NCT02921971|BG000|Baseline|Placebo|Placebo (for SAR156597), single SC injection QW up to Week 24.
11382828|NCT02921971|BG001|Baseline|SAR156597|SAR156597 200 mg, single SC injection QW up to Week 24.
11382829|NCT02921971|BG002|Baseline|Total|Total of all reporting groups
11382830|NCT02921971|FG000|Participant Flow|Placebo|Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.
11382831|NCT02921971|FG001|Participant Flow|SAR156597|SAR156597 200 milligram (mg), single SC injection QW up to Week 24.
11382832|NCT02921971|OG000|Outcome|Placebo|Placebo (for SAR156597), single SC injection QW up to Week 24.
11382833|NCT02921971|OG001|Outcome|SAR156597|SAR156597 200 mg, single SC injection QW up to Week 24.
11382834|NCT02921971|EG000|Reported Event|Placebo|Placebo (for SAR156597), single SC injection QW up to Week 24.
11382835|NCT02921971|EG001|Reported Event|SAR156597|SAR156597 200 mg single SC injection QW up to Week 24.
10789676|NCT03502187|EG001|Reported Event|NeuromuscularElectricalStimulation(NMES)|"NeuromuscularElectricalStimulation(NMES): The NMES treatment group received a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. It delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal).~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10789677|NCT03502187|EG002|Reported Event|Progressive Exercise Plan (PEP)|"Progressive Exercise Plan: The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.~Primary Care Management (PCM): All participants received standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application)."
10802460|NCT00085735|OG000|Outcome|Group 3 Medulloblastoma|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 3 medulloblastoma by methylation arrays
10802461|NCT00085735|OG001|Outcome|Group 4 Medulloblastoma|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 4 medulloblastoma by methylation arrays
10802462|NCT00085735|OG002|Outcome|Sonic Hedgehog (SHH) Medulloblastoma|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as SHH medulloblastoma by methylation arrays
10802463|NCT00085735|OG003|Outcome|Wingless (WNT) Medulloblastoma|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as WNT medulloblastoma by methylation arrays
10802464|NCT00085735|OG000|Outcome|Eligible and Evaluable Patients|All eligible and evaluable patients enrolled on ACNS0331
10802465|NCT00085735|EG000|Reported Event|Arm I (3-7 Years of Age, LDCSI, IFRT)|"See Detailed Description (Arm I)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
10802466|NCT00085735|EG001|Reported Event|Arm II (3-7 Years of Age, LDCSI, PFRT)|"See Detailed Description (Arm II)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
10802467|NCT00085735|EG002|Reported Event|Arm III (3-7 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm III)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
10802468|NCT00085735|EG003|Reported Event|Arm IV (3-7 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm IV)~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
10802469|NCT00085735|EG004|Reported Event|Arm V (8-21 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm V)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
10802470|NCT00085735|EG005|Reported Event|Arm VI (8-21 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm VI)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
10802471|NCT00003042|BG000|Baseline|Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue|"Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~cyclophosphamide~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~conventional surgery~peripheral blood stem cell transplantation"
10789678|NCT03447262|BG000|Baseline|VX-659/TEZ/IVA TC|Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789679|NCT03447262|FG000|Participant Flow|VX-659/TEZ/IVA Triple Combination (TC)|Participants from the parent studies 659-102 or 659-103 were administered VX-659 240 milligrams (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the TC treatment period for up to 96 weeks in the current study 659-105.
10789680|NCT03447262|OG000|Outcome|VX-659/TEZ/IVA TC|Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789681|NCT03447262|OG000|Outcome|VX-659/TEZ/IVA TC|Participants who either received placebo (matched to VX-659/TEZ/IVA) or VX-659/TEZ/IVA in the parent study 659-102 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789682|NCT03447262|OG000|Outcome|VX-659/TEZ/IVA TC|Participants who either received TEZ/IVA or VX-659/TEZ/IVA in the parent study 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789683|NCT03447262|OG000|Outcome|VX-659/TEZ/IVA TC|Participants who either received placebo (matched to VX-659/TEZ/IVA), TEZ/IVA or VX-659/TEZ/IVA in the parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789684|NCT03447262|EG000|Reported Event|VX-659/TEZ/IVA TC|Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
10789685|NCT03432819|BG000|Baseline|Siempre Seguiré|"We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT.~Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care."
10789686|NCT03432819|BG001|Baseline|Control|Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed.
10789687|NCT03432819|BG002|Baseline|Total|Total of all reporting groups
10789688|NCT03432819|FG000|Participant Flow|Siempre Seguiré|"We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT.~Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care."
10789689|NCT03432819|FG001|Participant Flow|Control|Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed.
10789690|NCT03432819|OG000|Outcome|Siempre Seguiré|"We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT.~Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care."
10789691|NCT03432819|OG001|Outcome|Control|Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed.
10789692|NCT03432819|EG000|Reported Event|Siempre Seguiré|"We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT.~Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care."
10789693|NCT03432819|EG001|Reported Event|Control|Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed.
11241177|NCT02484911|FG000|Participant Flow|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
10789694|NCT03323749|BG000|Baseline|Elamipretide|Double-blind Period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system, then Open-label Period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789695|NCT03323749|BG001|Baseline|Placebo|Double-Blind Period: Placebo comparator: 40 mg of placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks, then Open-label Period: Elamipretide: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789696|NCT03323749|BG002|Baseline|Total|Total of all reporting groups
10789697|NCT03323749|FG000|Participant Flow|Double-Blind Elamipretide, Then Open Label Elamepretide|"40 mg (0.5mL) elamipretide subcutaneous (SC) daily~elamipretide: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system, then elamipretide open-label treatment: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system"
10789698|NCT03323749|FG001|Participant Flow|Double-Blind Placebo Then Open-Label Elamepretide|"Placebo SC daily~Double-blind period: placebo comparator: Placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system. Open-label period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system."
10789699|NCT03323749|OG000|Outcome|Elamipretide|Double-blind Period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system
10789700|NCT03323749|OG001|Outcome|Placebo|Double-Blind Period: Placebo comparator: 40 mg of placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks
10789701|NCT03323749|OG000|Outcome|Elamipretide|Double-blind Period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system, then Open-label Period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789702|NCT03323749|OG001|Outcome|Placebo|Double-Blind Period: Placebo comparator: 40 mg of placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks, then Open-label Period: Elamipretide: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789703|NCT03323749|EG000|Reported Event|Double-Blind Elamipretide|Double-blind period: elamipretide: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system, then elamipretide open-label treatment: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789704|NCT03323749|EG001|Reported Event|Double-Blind Placebo|"Placebo SC daily~Double-blind period: placebo comparator: Placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system. Open-label period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system."
10789705|NCT03323749|EG002|Reported Event|Open-Label Elamipretide|Double blind period: elamipretide: 40mg (0.5mL) of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system, then elamipretide open-label treatment: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
10789706|NCT03323749|EG003|Reported Event|Open-Label Placebo|Double-blind period: placebo comparator: Placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system. Open-label period: 40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system.
10789707|NCT03322566|BG000|Baseline|Pembrolizumab + Chemotherapy + Epacadostat|Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789708|NCT03322566|BG001|Baseline|Pembrolizumab + Chemotherapy + Placebo|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789709|NCT03322566|BG002|Baseline|Pembrolizumab + Epacadostat|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
10789710|NCT03322566|BG003|Baseline|Total|Total of all reporting groups
10789711|NCT03322566|FG000|Participant Flow|Pembrolizumab + Chemotherapy + Epacadostat|Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789712|NCT03322566|FG001|Participant Flow|Pembrolizumab + Chemotherapy + Placebo|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789713|NCT03322566|FG002|Participant Flow|Pembrolizumab + Epacadostat|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
10789714|NCT03322566|OG000|Outcome|Pembrolizumab + Chemotherapy + Epacadostat|Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
11195003|NCT02155608|OG001|Outcome|Sham eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension.~Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly active eTNS in a 12 month extension period."
11195004|NCT02155608|OG000|Outcome|Active eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation.~Active eTNS: Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period."
11241178|NCT02484911|FG001|Participant Flow|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
10789715|NCT03322566|OG001|Outcome|Pembrolizumab + Chemotherapy + Placebo|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789716|NCT03322566|EG000|Reported Event|Pembrolizumab + Chemotherapy + Epacadostat|Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789717|NCT03322566|EG001|Reported Event|Pembrolizumab + Chemotherapy + Placebo|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
10789718|NCT03322566|EG002|Reported Event|Pembrolizumab + Epacadostat|Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
10789719|NCT03322566|EG003|Reported Event|Total|Total
10789720|NCT03322540|BG000|Baseline|Pembrolizumab + Epacadostat|Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
10789721|NCT03322540|BG001|Baseline|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
10789722|NCT03322540|BG002|Baseline|Total|Total of all reporting groups
10789723|NCT03322540|FG000|Participant Flow|Pembrolizumab + Epacadostat|Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
10789724|NCT03322540|FG001|Participant Flow|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
11241179|NCT02484911|OG000|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
10789725|NCT03322540|OG000|Outcome|Pembrolizumab + Epacadostat|Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
10789726|NCT03322540|OG001|Outcome|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
10789727|NCT03322540|OG000|Outcome|Pembrolizumab + Epacodostat|Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
10966665|NCT00888134|EG000|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
10789728|NCT03322540|EG000|Reported Event|Pembrolizumab + Epacadostat|Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
10789729|NCT03322540|EG001|Reported Event|Pembrolizumab + Placebo|Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
10789730|NCT03322540|EG002|Reported Event|Total|Total
10789731|NCT03240601|BG000|Baseline|Subthreshold|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789732|NCT03240601|BG001|Baseline|Active|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789733|NCT03240601|BG002|Baseline|Total|Total of all reporting groups
10789734|NCT03240601|FG000|Participant Flow|Subthreshold|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789735|NCT03240601|FG001|Participant Flow|Active|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789736|NCT03240601|OG000|Outcome|Subthreshold|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789737|NCT03240601|OG001|Outcome|Active|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
11241180|NCT02484911|OG001|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11241181|NCT02484911|OG001|Outcome|Aprepitant Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
10789738|NCT03240601|EG000|Reported Event|Subthreshold|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789739|NCT03240601|EG001|Reported Event|Active|"Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.~Transcutaneous spinal cord stimulation: For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz."
10789740|NCT03189719|BG000|Baseline|Pembrolizumab + SOC|Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789741|NCT03189719|BG001|Baseline|Placebo + SOC|Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789742|NCT03189719|BG002|Baseline|Total|Total of all reporting groups
10789743|NCT03189719|FG000|Participant Flow|Pembrolizumab + SOC|Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-fluorouracil (5-FU) 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789744|NCT03189719|FG001|Participant Flow|Placebo + SOC|Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789745|NCT03189719|OG000|Outcome|Pembrolizumab + SOC|Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789746|NCT03189719|OG001|Outcome|Placebo + SOC|Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789747|NCT03189719|EG000|Reported Event|Pembrolizumab + SOC|Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789748|NCT03189719|EG001|Reported Event|Placebo + SOC|Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
10789749|NCT03155997|BG000|Baseline|150 mg Abemaciclib + Endocrine Therapy|Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789750|NCT03155997|BG001|Baseline|Endocrine Therapy|Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789751|NCT03155997|BG002|Baseline|Total|Total of all reporting groups
10789752|NCT03155997|FG000|Participant Flow|150 mg Abemaciclib + Endocrine Therapy|Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789753|NCT03155997|FG001|Participant Flow|Endocrine Therapy|Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789754|NCT03155997|OG000|Outcome|150 mg Abemaciclib + Endocrine Therapy|Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789755|NCT03155997|OG001|Outcome|Endocrine Therapy|Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789756|NCT03155997|EG000|Reported Event|150 mg Abemaciclib + Endocrine Therapy|Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789757|NCT03155997|EG001|Reported Event|Endocrine Therapy|Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
10789758|NCT03104400|BG000|Baseline|Placebo|Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab by subcutaneous (SC) injection EOW.
10789759|NCT03104400|BG001|Baseline|Adalimumab 40 mg|Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.
10789760|NCT03104400|BG002|Baseline|Upadacitinib 15 mg|Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.
10789761|NCT03104400|BG003|Baseline|Upadacitinib 30 mg|Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
10789762|NCT03104400|BG004|Baseline|Total|Total of all reporting groups
10789763|NCT03104400|FG000|Participant Flow|Placebo / Upadacitinib 15 mg|Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56.
10789764|NCT03104400|FG001|Participant Flow|Placebo / Upadacitinib 30 mg|Participants randomized to receive matching placebo to upadacitinib orally QD for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks (Weeks 24 to 56), in addition to matching placebo to adalimumab administered by subcutaneous injection EOW from Weeks 1 to 56.
10789765|NCT03104400|FG002|Participant Flow|Adalimumab 40 mg|Participants randomized to receive adalimumab 40 mg by subcutaneous injection EOW and matching placebo to upadacitinib orally QD for 56 weeks.
10789766|NCT03104400|FG003|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.
10789767|NCT03104400|FG004|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.
10789768|NCT03104400|OG000|Outcome|Placebo|Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.
10789769|NCT03104400|OG001|Outcome|Adalimumab 40 mg|Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.
10789770|NCT03104400|OG002|Outcome|Upadacitinib 15 mg|Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.
10789771|NCT03104400|OG003|Outcome|Upadacitinib 30 mg|Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
10789772|NCT03104400|OG001|Outcome|Adalimumab 40 mg|Participants received adalimumab 40 mg SC EOW and placebo to upadacitinib orally QD.
10789773|NCT03104400|EG000|Reported Event|Placebo: Week 1-24|Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW for 24 weeks.
10789774|NCT03104400|EG001|Reported Event|Upadacitinib 15 mg: Week 1-24|Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW for 24 weeks.
11195005|NCT02155608|OG001|Outcome|Sham eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation.~Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period."
11195006|NCT02155608|OG000|Outcome|Active TNS|"Active TNS~Active TNS: Participants randomized to active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
10789775|NCT03104400|EG002|Reported Event|Upadacitinib 30 mg: Week 1-24|Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW for 24 weeks.
10789776|NCT03104400|EG003|Reported Event|Adalimumab: Week 1-24|Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD for 24 weeks.
10789777|NCT03104400|EG004|Reported Event|Upadacitinib 15 mg: Week 1-56|Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg for 56 weeks and participants originally randomized to placebo who switched to upadacitinib 15 mg at Week 24 and received upadacitinib 15 mg for 32 weeks. All participants also received matching placebo to adalimumab SC EOW.
10789778|NCT03104400|EG005|Reported Event|Upadacitinib 30 mg: Week 1-56|Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg for 56 weeks and participants originally randomized to placebo who switched to upadacitinib 30 mg at Week 24 and received upadacitinib 30 mg for 32 weeks. All participants also received matching placebo to adalimumab SC EOW.
10789779|NCT03104400|EG006|Reported Event|Adalimumab: Week 1-56|Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD for 56 weeks.
10789780|NCT03104374|BG000|Baseline|Placebo|Participants received placebo once daily for 24 weeks.
10789781|NCT03104374|BG001|Baseline|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 24 weeks.
10789782|NCT03104374|BG002|Baseline|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 24 weeks.
10789783|NCT03104374|BG003|Baseline|Total|Total of all reporting groups
10789784|NCT03104374|FG000|Participant Flow|Placebo / Upadacitinib 15 mg|Participants randomized to receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily.
10789785|NCT03104374|FG001|Participant Flow|Placebo / Upadacitinib 30 mg|Participants randomized to receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily.
10789786|NCT03104374|FG002|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily.
10789787|NCT03104374|FG003|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily.
10789788|NCT03104374|OG000|Outcome|Placebo|Participants received placebo once daily for 24 weeks.
10789789|NCT03104374|OG001|Outcome|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 24 weeks.
10789790|NCT03104374|OG002|Outcome|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 24 weeks.
10789791|NCT03104374|EG000|Reported Event|Placebo: Week 1-24|Participants received placebo once daily for 24 weeks.
10789792|NCT03104374|EG001|Reported Event|Upadacitinib 15 mg: Week 1-24|Participants received upadacitinib 15 mg once daily for 24 weeks.
10789793|NCT03104374|EG002|Reported Event|Upadacitinib 30 mg: Week 1-24|Participants received upadacitinib 30 mg once daily for 24 weeks.
10789794|NCT03104374|EG003|Reported Event|Upadacitinib 15 mg: Week 1-56|Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg for 56 weeks and participants originally randomized to placebo who switched to upadacitinib 15 mg at Week 24 and received upadacitinib 15 mg for 32 weeks.
10789795|NCT03104374|EG004|Reported Event|Upadacitinib 30 mg: Week 1-56|Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg for 56 weeks and participants originally randomized to placebo who switched to upadacitinib 30 mg at Week 24 and received upadacitinib 15 mg for 32 weeks.
10789796|NCT03072043|BG000|Baseline|Phase 1B Dose Level 1|Participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789797|NCT03072043|BG001|Baseline|Phase 1B Dos Level 2|Participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789798|NCT03072043|BG002|Baseline|Phase 1B Dose Level 3/ MTD|Participants treated at dose level 3/MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789799|NCT03072043|BG003|Baseline|Total|Total of all reporting groups
10789800|NCT03072043|FG000|Participant Flow|Phase 1b Dose Level 1|Participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789801|NCT03072043|FG001|Participant Flow|Phase 1B Dose Level 2|Participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789802|NCT03072043|FG002|Participant Flow|Phase 1B Dose Level 3 / Phase 2 MTD|Participants treated at dose level 3/Phase 2 MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789803|NCT03072043|OG000|Outcome|Phase 1b Dose Escalation|"Participants will receive intravenous infusions of APR-246 as a lead-in phase on days -14 to -11 starting at Dose Level 1 prior to starting cycle #1 of combination therapy with azacitidine. Combination therapy will consist of APR-246 on days 1-4 and azacitidine on days 4-10 (or days 4-5 and 8-12) of a 28 day cycle.~APR-246: Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD).~Azacitidine: Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m^2."
10789804|NCT03072043|OG000|Outcome|Phase 2: Participants in Dose Level 3/MTD|All participants who received at least one dose at level 3: 100 mg/kg LBW APR-246 + 75 mg Azacitidine
11195007|NCT02155608|OG001|Outcome|Sham TNS|"Sham TNS~Sham TNS: Participants randomized to sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
10789805|NCT03072043|OG000|Outcome|Evaluable Participants|All evaluable participants
10789806|NCT03072043|OG000|Outcome|Phase 1B Dose Level 1|All participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
11195008|NCT02155608|OG000|Outcome|Active eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension.~Active eTNS: Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period."
11195009|NCT02155608|OG001|Outcome|Sham eTNS|"Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension.~Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period."
11195010|NCT02155608|EG000|Reported Event|Active TNS|"Active TNS~Active TNS: Participants randomized to active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
11195011|NCT02155608|EG001|Reported Event|Sham TNS|"Sham TNS~Sham TNS: Participants randomized to sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep."
11195012|NCT02155660|BG000|Baseline|Benralizumab 10 mg|Every 8 weeks administered subcutaneously
11195013|NCT02155660|BG001|Baseline|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11195014|NCT02155660|BG002|Baseline|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11195015|NCT02155660|BG003|Baseline|Placebo|Every 8 weeks administered subcutaneously
11195016|NCT02155660|BG004|Baseline|Total|Total of all reporting groups
11195017|NCT02155660|FG000|Participant Flow|Benralizumab 10 mg|Every 8 weeks administered subcutaneously
11195018|NCT02155660|FG001|Participant Flow|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11195019|NCT02155660|FG002|Participant Flow|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11195020|NCT02155660|FG003|Participant Flow|Placebo|Every 8 weeks administered subcutaneously
11195021|NCT02155660|OG000|Outcome|Benralizumab 10 mg|Every 8 weeks administered subcutaneously
11195022|NCT02155660|OG001|Outcome|Benralizumab 30 mg|Every 8 weeks administered subcutaneously
11195023|NCT02155660|OG002|Outcome|Benralizumab 100 mg|Every 8 weeks administered subcutaneously
11195024|NCT02155660|OG003|Outcome|Placebo|Every 8 weeks administered subcutaneously
11195025|NCT02155660|EG000|Reported Event|Benra 10 mg|Every 8 weeks administered subcutaneously
11195026|NCT02155660|EG001|Reported Event|Benra 30 mg|Every 8 weeks administered subcutaneously
10789807|NCT03072043|OG001|Outcome|Phase 1B Dose Level 2|All participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
11195027|NCT02155660|EG002|Reported Event|Benra 100 mg|Every 8 weeks administered subcutaneously
11195028|NCT02155660|EG003|Reported Event|Placebo|Every 8 weeks administered subcutaneously
11195029|NCT02155712|BG000|Baseline|Cohort 1 Cementless|"Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.~Triathlon Tritanium Knee: Cementless"
11195030|NCT02155712|BG001|Baseline|Cohort 2 Cemented|"Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.~Triathlon Knee: Cemented"
11195031|NCT02155712|BG002|Baseline|Total|Total of all reporting groups
11195032|NCT02155712|FG000|Participant Flow|Cohort 1 Cementless|"Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.~It should be noted that Cohort 1 over-enrolled by 17 cases for a total of 373 cases."
11195033|NCT02155712|FG001|Participant Flow|Cohort 2 Cemented|Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
10789808|NCT03072043|OG002|Outcome|Phase 1B: Dose Level 3 / Phase 2 MTD|All participants treated at dose level 3/ Phase 2 MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2
10789809|NCT03072043|OG000|Outcome|All Participants|All participants
10789810|NCT03072043|EG000|Reported Event|Phase 1b Dose Level 1|All participants treated at dose level 1: APR-246 50 mg/kg lean body weight (LBW) + Azacitidine 75 mg/m^2
10789811|NCT03072043|EG001|Reported Event|Phase 1B Dose Level 2|All participants treated at dose level 2: APR-246 75 mg/kg lean body weight (LBW) + Azacitidine 75 mg/m^2
10789812|NCT03072043|EG002|Reported Event|Phase 1B Dose Level 3/Phase 2 MTD|All participants treated at dose level 3 & Phase 2: APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75 mg/m^2
10789813|NCT02970981|BG000|Baseline|Nivolumab and Ipilimumab|"Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)~Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.~Nivolumab~Ipilimumab"
10789814|NCT02970981|FG000|Participant Flow|Nivolumab and Ipilimumab|"Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)~Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.~Nivolumab~Ipilimumab"
10789815|NCT02970981|OG000|Outcome|Nivolumab and Ipilimumab|"Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)~Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.~Nivolumab~Ipilimumab"
10789816|NCT02970981|EG000|Reported Event|Nivolumab and Ipilimumab|"Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)~Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.~Nivolumab~Ipilimumab"
10789817|NCT02946853|BG000|Baseline|CRT-D|"Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789818|NCT02946853|BG001|Baseline|CRT-D and AVJ Ablation|"Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.~Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789819|NCT02946853|BG002|Baseline|Total|Total of all reporting groups
10789820|NCT02946853|FG000|Participant Flow|CRT-D|"Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789821|NCT02946853|FG001|Participant Flow|CRT-D and AVJ Ablation|"Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.~Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789822|NCT02946853|OG000|Outcome|CRT-D|"Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789823|NCT02946853|OG001|Outcome|CRT-D and AVJ Ablation|"Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.~Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789824|NCT02946853|EG000|Reported Event|CRT-D|"Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789825|NCT02946853|EG001|Reported Event|CRT-D and AVJ Ablation|"Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.~Atrioventricular junctional (AVJ) ablation: RF energy delivery to AV node to create complete AV block~Cardiac resynchronization therapy - defibrillator: Insertion of device capable of providing biventricular pacing and cardiac defibrillation"
10789826|NCT02905032|BG000|Baseline|Standard Care|Observations were in the clinical encounter via video, audio or observational notes.
10789827|NCT02905032|BG001|Baseline|Standard Care + Decision Aid|"Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.~Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient."
10789828|NCT02905032|BG002|Baseline|Clinicians|Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
10789829|NCT02905032|BG003|Baseline|Total|Total of all reporting groups
10789830|NCT02905032|FG000|Participant Flow|Standard Care|Observations were in the clinical encounter via video, audio or observational notes.
10789831|NCT02905032|FG001|Participant Flow|Standard Care + Decision Aid|"Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.~Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient."
10789832|NCT02905032|FG002|Participant Flow|Clinicians|Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
10789833|NCT02905032|OG000|Outcome|Standard Care|Observations were in the clinical encounter via video, audio or observational notes.
11195034|NCT02155712|OG000|Outcome|Cohort 1 Cementless|Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
10789834|NCT02905032|OG001|Outcome|Standard Care + Decision Aid|"Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.~Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient."
10789835|NCT02905032|EG000|Reported Event|Standard Care|Observations were in the clinical encounter via video, audio or observational notes.
10789836|NCT02905032|EG001|Reported Event|Standard Care + Decision Aid|"Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.~Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient."
10789837|NCT02905032|EG002|Reported Event|Clinicians|Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
10789838|NCT02837029|BG000|Baseline|Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks)|"Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789839|NCT02837029|BG001|Baseline|Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks)|"Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789840|NCT02837029|BG002|Baseline|Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks)|"The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.~Phase 1b never opened to accrual due to funding issues."
10789841|NCT02837029|BG003|Baseline|Total|Total of all reporting groups
10789842|NCT02837029|FG000|Participant Flow|Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks)|"Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789843|NCT02837029|FG001|Participant Flow|Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks)|"Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789844|NCT02837029|FG002|Participant Flow|Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks)|"The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.~Phase 1b never opened to accrual due to funding issues."
10789845|NCT02837029|OG000|Outcome|Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab)|"Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Yttrium Y 90 Glass Microspheres: Given IA"
10789846|NCT02837029|OG000|Outcome|Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks)|"The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.~Phase 1b never opened to accrual due to funding issues."
10789847|NCT02837029|OG000|Outcome|Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks)|"Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789848|NCT02837029|OG001|Outcome|Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks)|"Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
11195035|NCT02155712|OG001|Outcome|Cohort 2 Cemented|Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
10789849|NCT02837029|EG000|Reported Event|Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks)|"Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789850|NCT02837029|EG001|Reported Event|Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks)|"Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes."
10789851|NCT02837029|EG002|Reported Event|Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks)|"The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 & 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity.~Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.~Phase 1b never opened to accrual due to funding issues."
10789852|NCT02740127|BG000|Baseline|General Anesthesia and Caudal Nerve Block|If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
10789853|NCT02740127|BG001|Baseline|General Anesthesia Only|Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
10789854|NCT02740127|BG002|Baseline|Total|Total of all reporting groups
10789855|NCT02740127|FG000|Participant Flow|General Anesthesia and Caudal Nerve Block|If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
10789856|NCT02740127|FG001|Participant Flow|General Anesthesia Only|Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
10789857|NCT02740127|OG000|Outcome|General Anesthesia and Caudal Nerve Block|If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
10789858|NCT02740127|OG001|Outcome|General Anesthesia Only|Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
10789859|NCT02740127|EG000|Reported Event|General Anesthesia and Caudal Nerve Block|If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
10789860|NCT02740127|EG001|Reported Event|General Anesthesia Only|Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
11241182|NCT02484911|EG000|Reported Event|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11241183|NCT02484911|EG001|Reported Event|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
10789861|NCT02737553|BG000|Baseline|Enclosed Morcellation|In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove.
10789862|NCT02737553|BG001|Baseline|Vaginal Morcellation|In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.
10789863|NCT02737553|BG002|Baseline|Total|Total of all reporting groups
10789864|NCT02737553|FG000|Participant Flow|Enclosed Morcellation|In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove.
10789865|NCT02737553|FG001|Participant Flow|Vaginal Morcellation|In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.
10789866|NCT02737553|OG000|Outcome|Enclosed Morcellation|In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove.
10789867|NCT02737553|OG001|Outcome|Vaginal Morcellation|In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.
10789868|NCT02737553|OG000|Outcome|Enclosed Morcellation|In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature.
10789869|NCT02737553|EG000|Reported Event|Enclosed Morcellation|In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove.
10789870|NCT02737553|EG001|Reported Event|Vaginal Morcellation|In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.
10789871|NCT02737475|BG000|Baseline|Escalation Part 1: BMS 20 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789872|NCT02737475|BG001|Baseline|Escalation Part 1: BMS 40 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789873|NCT02737475|BG002|Baseline|Escalation Part 1: BMS 80 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789874|NCT02737475|BG003|Baseline|Escalation Part 1: BMS 160 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789875|NCT02737475|BG004|Baseline|Escalation Part 1: BMS 320 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789876|NCT02737475|BG005|Baseline|Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789877|NCT02737475|BG006|Baseline|Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789878|NCT02737475|BG007|Baseline|Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789879|NCT02737475|BG008|Baseline|Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789880|NCT02737475|BG009|Baseline|Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789881|NCT02737475|BG010|Baseline|Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789882|NCT02737475|BG011|Baseline|Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789883|NCT02737475|BG012|Baseline|Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789884|NCT02737475|BG013|Baseline|Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789885|NCT02737475|BG014|Baseline|Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789886|NCT02737475|BG015|Baseline|Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)|Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
10789887|NCT02737475|BG016|Baseline|Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W|Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
10789888|NCT02737475|BG017|Baseline|Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W|Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
10789889|NCT02737475|BG018|Baseline|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789890|NCT02737475|BG019|Baseline|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789891|NCT02737475|BG020|Baseline|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10789892|NCT02737475|BG021|Baseline|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
11195036|NCT02155712|EG000|Reported Event|Cohort 1 Cementless|"Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.~Triathlon Tritanium Knee: Cementless"
11195037|NCT02155712|EG001|Reported Event|Cohort 2 Cemented|"Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.~Triathlon Knee: Cemented"
11195038|NCT02155725|BG000|Baseline|Clottafact|Human fibrinogen concentrate 3g intravenous use. 2 vials of 1,5 g/100mL, each vial of powder was reconstitued with 100 mL of sterile water for injection.
11195039|NCT02155725|BG001|Baseline|Placebo|Placebo intravenous use. 2 vials of 100 mL, eache vial of powder was reconttitued with 100 mL of sterile water for injection.
11195040|NCT02155725|BG002|Baseline|Total|Total of all reporting groups
11195041|NCT02155725|FG000|Participant Flow|Clottafact|Human fibrinogen concentrate 3g intravenous use. 2 vials of 1,5 g/100mL, each vial of powder was reconstituted with 100 mL of sterile water for injection.
11195042|NCT02155725|FG001|Participant Flow|Placebo|Placebo intravenous use. 2 vials of 100 mL, each vial of powder was reconstituted with 100 mL of sterile water.
11195043|NCT02155725|OG000|Outcome|Per Protocole (PP) Set Clottafact|Patients with no missing data for the primary criterion.
11195044|NCT02155725|OG001|Outcome|Per Protocole (PP) Set Placebo|Patients with no missing data for the primary criterion.
11195045|NCT02155725|OG002|Outcome|Intention To Treat (ITT) Set Clottafact|All patients treated with Clottafact. (patients who received at least one infusion of Clottafact)
11195046|NCT02155725|OG003|Outcome|Intention To Treat (ITT) Set Placebo|All patients treated with Placebo. (patients who received at least one infusion of placebo)
11195047|NCT02155725|OG004|Outcome|Full Analysis Set (FAS) Clottafact|Patients treated with Clottafact of the ITT Set with no missing data for the primary criteria.
11195048|NCT02155725|OG005|Outcome|Full Analysis Set (FAS) Placebo|Patients treated with Placebo of the ITT Set with no missing data for the primary criteria.
11195049|NCT02155725|OG000|Outcome|FAS Set Clottafact|Patients treated with Clottafact of the ITT Set with no missing data for the primary criteria.
10789893|NCT02737475|BG022|Baseline|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789894|NCT02737475|BG023|Baseline|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10966666|NCT00888173|BG000|Baseline|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
11195050|NCT02155725|OG001|Outcome|FAS Set Placebo|Patients treated with Placebo of the ITT Set with no missing data for the primary criteria.
11195051|NCT02155725|EG000|Reported Event|Clottafact|Human fibrinogen concentrate 3g intravenous use. 2 vials of 1,5 g/100mL, each vial of powder was reconstitued with 100 mL of sterile water for injection.
10789895|NCT02737475|BG024|Baseline|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789896|NCT02737475|BG025|Baseline|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10789897|NCT02737475|BG026|Baseline|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789898|NCT02737475|BG027|Baseline|Total|Total of all reporting groups
10789899|NCT02737475|FG000|Participant Flow|Escalation Part 1: BMS 20 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789900|NCT02737475|FG001|Participant Flow|Escalation Part 1: BMS 40 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789901|NCT02737475|FG002|Participant Flow|Escalation Part 1: BMS 80 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789902|NCT02737475|FG003|Participant Flow|Escalation Part 1: BMS 160 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789903|NCT02737475|FG004|Participant Flow|Escalation Part 1: BMS 320 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789904|NCT02737475|FG005|Participant Flow|Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789905|NCT02737475|FG006|Participant Flow|Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789906|NCT02737475|FG007|Participant Flow|Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789907|NCT02737475|FG008|Participant Flow|Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789908|NCT02737475|FG009|Participant Flow|Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789909|NCT02737475|FG010|Participant Flow|Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789910|NCT02737475|FG011|Participant Flow|Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789911|NCT02737475|FG012|Participant Flow|Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789912|NCT02737475|FG013|Participant Flow|Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789913|NCT02737475|FG014|Participant Flow|Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789914|NCT02737475|FG015|Participant Flow|Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)|Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
10789915|NCT02737475|FG016|Participant Flow|Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W|Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
10789916|NCT02737475|FG017|Participant Flow|Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W|Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
10966667|NCT00888173|FG000|Participant Flow|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
10789917|NCT02737475|FG018|Participant Flow|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789918|NCT02737475|FG019|Participant Flow|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789919|NCT02737475|FG020|Participant Flow|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10789920|NCT02737475|FG021|Participant Flow|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789921|NCT02737475|FG022|Participant Flow|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789922|NCT02737475|FG023|Participant Flow|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789923|NCT02737475|FG024|Participant Flow|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789924|NCT02737475|FG025|Participant Flow|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10789925|NCT02737475|FG026|Participant Flow|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789926|NCT02737475|OG000|Outcome|Escalation Part 1: BMS 20 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789927|NCT02737475|OG001|Outcome|Escalation Part 1: BMS 40 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789928|NCT02737475|OG002|Outcome|Escalation Part 1: BMS 80 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789929|NCT02737475|OG003|Outcome|Escalation Part 1: BMS 160 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789930|NCT02737475|OG004|Outcome|Escalation Part 1: BMS 320 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789931|NCT02737475|OG005|Outcome|Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789932|NCT02737475|OG006|Outcome|Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789933|NCT02737475|OG007|Outcome|Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789934|NCT02737475|OG008|Outcome|Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
11195052|NCT02155725|EG001|Reported Event|Placebo|Placebo intravenous use. 2 vials of 100 mL, eache vial of powder was reconttitued with 100 mL of sterile water.
10789935|NCT02737475|OG009|Outcome|Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789936|NCT02737475|OG010|Outcome|Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789937|NCT02737475|OG011|Outcome|Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789938|NCT02737475|OG012|Outcome|Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789939|NCT02737475|OG013|Outcome|Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789940|NCT02737475|OG014|Outcome|Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789941|NCT02737475|OG015|Outcome|Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)|Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
10789942|NCT02737475|OG016|Outcome|Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W|Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
10789943|NCT02737475|OG017|Outcome|Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W|Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
10789944|NCT02737475|OG018|Outcome|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789945|NCT02737475|OG019|Outcome|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789946|NCT02737475|OG020|Outcome|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10789947|NCT02737475|OG021|Outcome|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789948|NCT02737475|OG022|Outcome|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789949|NCT02737475|OG023|Outcome|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789950|NCT02737475|OG024|Outcome|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
11195053|NCT02155738|BG000|Baseline|Vaginal Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent vaginal surgery."
11195054|NCT02155738|BG001|Baseline|Vaginal Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent vaginal surgery."
10966668|NCT00888173|OG000|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
10789951|NCT02737475|OG025|Outcome|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10789952|NCT02737475|OG026|Outcome|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789953|NCT02737475|OG025|Outcome|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789954|NCT02737475|OG000|Outcome|Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789955|NCT02737475|OG001|Outcome|Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789956|NCT02737475|OG002|Outcome|Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789957|NCT02737475|OG003|Outcome|Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789958|NCT02737475|OG004|Outcome|Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789959|NCT02737475|OG005|Outcome|Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)|Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
10789960|NCT02737475|OG006|Outcome|Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W|Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
10789961|NCT02737475|OG007|Outcome|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789962|NCT02737475|OG008|Outcome|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789963|NCT02737475|OG009|Outcome|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10789964|NCT02737475|OG010|Outcome|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
11195055|NCT02155738|BG002|Baseline|Laparoscopic Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent laparoscopic surgery."
10789965|NCT02737475|OG011|Outcome|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789966|NCT02737475|OG012|Outcome|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10802472|NCT00003042|BG001|Baseline|High-dose Chemo With Rescue|"Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation"
10789967|NCT02737475|OG013|Outcome|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789968|NCT02737475|OG014|Outcome|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10789969|NCT02737475|OG015|Outcome|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789970|NCT02737475|OG000|Outcome|Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789971|NCT02737475|OG001|Outcome|Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789972|NCT02737475|OG002|Outcome|Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789973|NCT02737475|OG003|Outcome|Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789974|NCT02737475|OG004|Outcome|Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789975|NCT02737475|OG005|Outcome|Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W|Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
10789976|NCT02737475|OG006|Outcome|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789977|NCT02737475|OG007|Outcome|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789978|NCT02737475|OG008|Outcome|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10789979|NCT02737475|OG009|Outcome|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
10789980|NCT02737475|OG000|Outcome|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789981|NCT02737475|OG001|Outcome|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
11195056|NCT02155738|BG003|Baseline|Laparoscopic Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent laparoscopic surgery."
11195057|NCT02155738|BG004|Baseline|Total|Total of all reporting groups
10789982|NCT02737475|OG002|Outcome|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10789983|NCT02737475|OG003|Outcome|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10789984|NCT02737475|OG000|Outcome|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10789985|NCT02737475|EG000|Reported Event|Escalation Part 1: BMS 20 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789986|NCT02737475|EG001|Reported Event|Escalation Part 1: BMS 40 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789987|NCT02737475|EG002|Reported Event|Escalation Part 1: BMS 80 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789988|NCT02737475|EG003|Reported Event|Escalation Part 1: BMS 160 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789989|NCT02737475|EG004|Reported Event|Escalation Part 1: BMS 320 mg Q2W|Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
10789990|NCT02737475|EG005|Reported Event|Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789991|NCT02737475|EG006|Reported Event|Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789992|NCT02737475|EG007|Reported Event|Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789993|NCT02737475|EG008|Reported Event|Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789994|NCT02737475|EG009|Reported Event|Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W|Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
10789995|NCT02737475|EG010|Reported Event|Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789996|NCT02737475|EG011|Reported Event|Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789997|NCT02737475|EG012|Reported Event|Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789998|NCT02737475|EG013|Reported Event|Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10789999|NCT02737475|EG014|Reported Event|Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W|Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
10790000|NCT02737475|EG015|Reported Event|Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)|Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
10790001|NCT02737475|EG016|Reported Event|Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W|Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
10790002|NCT02737475|EG017|Reported Event|Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W|Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
10802473|NCT00003042|BG002|Baseline|Total|Total of all reporting groups
10966669|NCT00888173|EG000|Reported Event|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
10966670|NCT00888238|BG000|Baseline|All Patients|All Randomized patients
10790003|NCT02737475|EG018|Reported Event|Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10790004|NCT02737475|EG019|Reported Event|Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)|Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
10790005|NCT02737475|EG020|Reported Event|Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
10790006|NCT02737475|EG021|Reported Event|Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)|Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
10790007|NCT02737475|EG022|Reported Event|Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10790008|NCT02737475|EG023|Reported Event|Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10790009|NCT02737475|EG024|Reported Event|Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W|BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
10790010|NCT02737475|EG025|Reported Event|Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W|Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
10790011|NCT02737475|EG026|Reported Event|Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine|Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
10790012|NCT02703714|BG000|Baseline|Pembrolizumab and GM-CSF|Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive sargramostim subcutaneous injection (SC) on days 1-14 of courses 1-2 or 2-3. Treatment repeats every 21 days for up to 2 courses for sargramostim and for up to 35 courses (24 months) for pembrolizumab in the absence of disease or unaccepted toxicity.
10790013|NCT02703714|FG000|Participant Flow|Pembrolizumab and GM-CSF|Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive sargramostim subcutaneous injection (SC) on days 1-14 of courses 1-2 or 2-3. Treatment repeats every 21 days for up to 2 courses for sargramostim and for up to 35 courses (24 months) for pembrolizumab in the absence of disease or unaccepted toxicity.
10790014|NCT02703714|OG000|Outcome|Pembrolizumab and GM-CSF|Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive sargramostim subcutaneous injection (SC) on days 1-14 of courses 1-2 or 2-3. Treatment repeats every 21 days for up to 2 courses for sargramostim and for up to 35 courses (24 months) for pembrolizumab in the absence of disease or unaccepted toxicity.
10790015|NCT02703714|EG000|Reported Event|Pembrolizumab and GM-CSF|Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive sargramostim subcutaneous injection (SC) on days 1-14 of courses 1-2 or 2-3. Treatment repeats every 21 days for up to 2 courses for sargramostim and for up to 35 courses (24 months) for pembrolizumab in the absence of disease or unaccepted toxicity.
10790016|NCT02642965|BG000|Baseline|Treatment (CPX-351 and FLAG)|"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.~COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5."
10790017|NCT02642965|FG000|Participant Flow|Treatment (CPX-351 and FLAG)|"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.~COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5."
10790018|NCT02642965|OG000|Outcome|Treatment (CPX-351 and FLAG)|"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.~COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5."
10790019|NCT02642965|EG000|Reported Event|Treatment (CPX-351 and FLAG)|"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.~COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5."
10802474|NCT00003042|FG000|Participant Flow|Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue|"Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~cyclophosphamide~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~conventional surgery~peripheral blood stem cell transplantation"
10802475|NCT00003042|FG001|Participant Flow|High-dose Chemo With Rescue|"Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation"
10802476|NCT00003042|OG000|Outcome|Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue|"Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~cyclophosphamide~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~conventional surgery~peripheral blood stem cell transplantation"
10802477|NCT00003042|OG001|Outcome|High-dose Chemo With Rescue|"Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation"
10802478|NCT00003042|EG000|Reported Event|Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue|"Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~cyclophosphamide~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~conventional surgery~peripheral blood stem cell transplantation"
10802479|NCT00003042|EG001|Reported Event|High-dose Chemo With Rescue|"Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.~filgrastim~cisplatin~doxorubicin hydrochloride~melphalan~mesna~paclitaxel~tamoxifen citrate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation"
10966671|NCT00888238|FG000|Participant Flow|Sitagliptin / Sitagliptin / Placebo|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
11195058|NCT02155738|FG000|Participant Flow|Vaginal Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent vaginal surgery."
11195059|NCT02155738|FG001|Participant Flow|Vaginal Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent vaginal surgery."
11195060|NCT02155738|FG002|Participant Flow|Laparoscopic Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent laparoscopic surgery."
11195061|NCT02155738|FG003|Participant Flow|Laparoscopic Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent laparoscopic surgery."
11195062|NCT02155738|OG000|Outcome|Vaginal Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent vaginal surgery."
10790020|NCT02629159|BG000|Baseline|Placebo|Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
10790021|NCT02629159|BG001|Baseline|Adalimumab|Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
10790022|NCT02629159|BG002|Baseline|Upadacitinib|Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
10790023|NCT02629159|BG003|Baseline|Total|Total of all reporting groups
10790024|NCT02629159|FG000|Participant Flow|Placebo|Participants randomized to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were switched to 15 mg upadacitinib QD.
10790025|NCT02629159|FG001|Participant Flow|Adalimumab|Participants randomized to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were switched to 15 mg upadacitinib orally QD.
10790026|NCT02629159|FG002|Participant Flow|Upadacitinib|Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were switched to 40 mg adalimumab eow.
10790027|NCT02629159|OG000|Outcome|Placebo|Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
10790028|NCT02629159|OG001|Outcome|Adalimumab|Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
10790029|NCT02629159|OG002|Outcome|Upadacitinib|Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
10790030|NCT02629159|EG000|Reported Event|Placebo|"Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.~Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued."
10790031|NCT02629159|EG001|Reported Event|Adalimumab|"Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.~Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued."
10790032|NCT02629159|EG002|Reported Event|Upadacitinib|"Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.~Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued."
10790033|NCT02629159|EG003|Reported Event|Placebo / Upadacitinib|"Participants who originally received placebo were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD.~Includes all events that occurred after the switch to rescue treatment up to Week 26."
10790034|NCT02629159|EG004|Reported Event|Adalimumab / Upadacitinib|"Participants who originally received adalimumab were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD.~Includes all events that occurred after the switch to rescue treatment up to Week 26."
10790035|NCT02629159|EG005|Reported Event|Upadacitinib / Adalimumab|"Participants who originally received 15 mg upadacitinib QD were switched at Weeks 14, 18, or 22 to receive 40 mg adalimumab eow.~Includes all events that occurred after the switch to rescue treatment up to Week 26."
10790036|NCT02604433|BG000|Baseline|Luspatercept + BSC|"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period.~BSC = Best Supportive Care"
10790037|NCT02604433|BG001|Baseline|Placebo + BSC|"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days.~BSC = Best Supportive Care"
10790038|NCT02604433|BG002|Baseline|Total|Total of all reporting groups
10966672|NCT00888238|FG001|Participant Flow|Sitagliptin / Placebo / Sitagliptin|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
11195063|NCT02155738|OG001|Outcome|Vaginal Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent vaginal surgery."
11382836|NCT02886286|BG000|Baseline|Bupivacaine + Opioid|"Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.~Bupivacaine: Patient-activated intrathecal bolus for incident pain~Opioid: Patient-activated intrathecal bolus for incident pain"
11382837|NCT02886286|BG001|Baseline|Opioid|"Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.~Opioid: Patient-activated intrathecal bolus for incident pain"
11382838|NCT02886286|BG002|Baseline|Total|Total of all reporting groups
11382839|NCT02886286|FG000|Participant Flow|Bupivacaine + Opioid First, Then Opioid|"Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.~Bupivacaine: Patient-activated intrathecal bolus for incident pain~Opioid: Patient-activated intrathecal bolus for incident pain~Patients received Bupivacaine + Opioid first for 7 days. Patients were crossed over at day 8 to receive Opioid only. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382840|NCT02886286|FG001|Participant Flow|Opioid First, Then Bupivacaine + Opioid|"Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.~Opioid: Patient-activated intrathecal bolus for incident pain~Patients received Opioid only first for 7 days. Patients were crossed over at day 8 to receive Bupivacaine + Opioid. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382841|NCT02886286|OG000|Outcome|Bupivacaine + Opioid|"Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.~Bupivacaine: Patient-activated intrathecal bolus for incident pain~Opioid: Patient-activated intrathecal bolus for incident pain~Patients who received Bupivacaine + Opioid for 7 days, either in the first 7 days or last 7 days of the study. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382842|NCT02886286|OG001|Outcome|Opioid|"Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.~Opioid: Patient-activated intrathecal bolus for incident pain~Patients received Opioid only for 7 days, either in the first 7 days or last 7 days of the study. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382843|NCT02886286|EG000|Reported Event|Bupivacaine + Opioid|"Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.~Bupivacaine: Patient-activated intrathecal bolus for incident pain~Opioid: Patient-activated intrathecal bolus for incident pain~Patients who received Bupivacaine + Opioid for 7 days, either in the first 7 days or last 7 days of the study. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382844|NCT02886286|EG001|Reported Event|Opioid|"Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.~Opioid: Patient-activated intrathecal bolus for incident pain~Patients received Opioid only for 7 days, either in the first 7 days or last 7 days of the study. Bolus delivery was locked out after each medication change for one to two days. Data were collected on days 4-7 and days 11-14."
11382845|NCT02865187|BG000|Baseline|Vitamin D + Hormonal Contraception|"600IU/day Vitamin D + hormonal contraception~Vitamin D: Vitamin D 600IU/day~Hormonal contraception: Hormonal contraceptives"
11382846|NCT02865187|BG001|Baseline|Vit D + Non-hormonal Contraception|"600IU/day Vitamin D~Vitamin D: Vitamin D 600IU/day"
11382847|NCT02865187|BG002|Baseline|Total|Total of all reporting groups
11382848|NCT02865187|FG000|Participant Flow|Vitamin D + Hormonal Contraception|"600IU/day Vitamin D + hormonal contraception~Vitamin D: Vitamin D 600IU/day~Hormonal contraception: Hormonal contraceptives"
11382849|NCT02865187|FG001|Participant Flow|Vit D + Non-hormonal Contraception|"600IU/day Vitamin D~Vitamin D: Vitamin D 600IU/day"
11382850|NCT02865187|OG000|Outcome|Vitamin D + Hormonal Contraception|"600IU/day Vitamin D + hormonal contraception~Vitamin D: Vitamin D 600IU/day~Hormonal contraception: Hormonal contraceptives"
11382851|NCT02865187|OG001|Outcome|Vit D + Non-hormonal Contraception|"600IU/day Vitamin D~Vitamin D: Vitamin D 600IU/day"
10790039|NCT02604433|FG000|Participant Flow|Luspatercept + BSC|"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period.~BSC = Best Supportive Care"
10790040|NCT02604433|FG001|Participant Flow|Placebo + BSC|"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days.~BSC = Best Supportive Care"
10790041|NCT02604433|OG000|Outcome|Luspatercept + BSC|"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period.~BSC = Best Supportive Care"
10790042|NCT02604433|OG001|Outcome|Placebo + BSC|"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days.~BSC = Best Supportive Care"
10790043|NCT02604433|EG000|Reported Event|Luspatercept + BSC|"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period.~BSC = Best Supportive Care"
10790044|NCT02604433|EG001|Reported Event|Placebo + BSC|"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days.~BSC = Best Supportive Care"
10790045|NCT02519738|BG000|Baseline|Silver Nitrate|"Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.~Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks."
10790046|NCT02519738|BG001|Baseline|Kenalog (Triamcinolone)|"Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.~Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks."
10790047|NCT02519738|BG002|Baseline|Washcloth Abrasion|"Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.~Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks."
10790048|NCT02519738|BG003|Baseline|Total|Total of all reporting groups
10790049|NCT02519738|FG000|Participant Flow|Silver Nitrate|"Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.~Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks."
10790050|NCT02519738|FG001|Participant Flow|Kenalog (Triamcinolone)|"Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.~Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks."
10790051|NCT02519738|FG002|Participant Flow|Washcloth Abrasion|"Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.~Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks."
10790052|NCT02519738|OG000|Outcome|Silver Nitrate|"Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.~Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks."
10790053|NCT02519738|OG001|Outcome|Kenalog (Triamcinolone)|"Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.~Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks."
11338919|NCT03620162|OG000|Outcome|Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™|Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
10790054|NCT02519738|OG002|Outcome|Washcloth Abrasion|"Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.~Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks."
10790055|NCT02519738|EG000|Reported Event|Silver Nitrate|"Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.~Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks."
10790056|NCT02519738|EG001|Reported Event|Kenalog (Triamcinolone)|"Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.~Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks."
10790057|NCT02519738|EG002|Reported Event|Washcloth Abrasion|"Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.~Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks."
10790058|NCT02502071|BG000|Baseline|Sodium Bicarbonate|"All participants will receive 2 doses of 1950mg Sodium Bicarbonate~sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate"
10790059|NCT02502071|FG000|Participant Flow|Sodium Bicarbonate|"All participants will receive 2 doses of 1950mg Sodium Bicarbonate~sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate"
11195064|NCT02155738|OG002|Outcome|Laparoscopic Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent laparoscopic surgery."
11195065|NCT02155738|OG003|Outcome|Laparoscopic Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent laparoscopic surgery."
11195066|NCT02155738|EG000|Reported Event|Vaginal Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent vaginal surgery."
11195067|NCT02155738|EG001|Reported Event|Vaginal Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent vaginal surgery."
10790060|NCT02502071|OG000|Outcome|Sodium Bicarbonate|"All participants will receive 2 doses of 1950mg Sodium Bicarbonate~sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate"
11195068|NCT02155738|EG002|Reported Event|Laparoscopic Surgery - Placebo|"100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV normal saline~These subjects underwent laparoscopic surgery."
11195069|NCT02155738|EG003|Reported Event|Laparoscopic Surgery - IV Acetaminophen|"100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.~IV Acetaminophen~These subjects underwent laparoscopic surgery."
11195070|NCT02155829|BG000|Baseline|Riluzole|"Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks~Riluzole"
11195071|NCT02155829|BG001|Baseline|Placebo|"Weeks 1 and 2: Placebo 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Placebo 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks~Placebo (for Riluzole)"
11195072|NCT02155829|BG002|Baseline|Total|Total of all reporting groups
11195073|NCT02155829|FG000|Participant Flow|Riluzole|"Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks"
11195074|NCT02155829|FG001|Participant Flow|Placebo|"Weeks 1 and 2: Placebo 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Placebo 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks"
11195075|NCT02155829|OG000|Outcome|Riluzole|"Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks~Riluzole"
11195076|NCT02155829|OG001|Outcome|Placebo|"Weeks 1 and 2: Placebo 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Placebo 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks~Placebo (for Riluzole)"
11195077|NCT02155829|OG000|Outcome|Riluzole|"Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks"
11195078|NCT02155829|EG000|Reported Event|Riluzole|"Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks"
11195079|NCT02155829|EG001|Reported Event|Placebo|"Weeks 1 and 2: Placebo 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks~Weeks 3 to 8 (optional dose increase): 2 Placebo 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks"
10790061|NCT02502071|EG000|Reported Event|Sodium Bicarbonate|"All participants will receive 2 doses of 1950mg Sodium Bicarbonate~sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate"
10966673|NCT00888238|FG002|Participant Flow|Placebo / Sitagliptin / Sitagliptin|Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
10966674|NCT00888238|OG000|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
10966675|NCT00888238|OG001|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
11195080|NCT02155881|BG000|Baseline|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
10966676|NCT00888238|EG000|Reported Event|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
10966677|NCT00888238|EG001|Reported Event|Placebo|12 subjects received a single-dose of placebo in 1 period.
11195081|NCT02155881|BG001|Baseline|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
11195082|NCT02155881|BG002|Baseline|Total|Total of all reporting groups
10790062|NCT02420821|BG000|Baseline|Sunitinib|Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790063|NCT02420821|BG001|Baseline|Atezolizumab + Bevacizumab|Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790064|NCT02420821|BG002|Baseline|Total|Total of all reporting groups
10790065|NCT02420821|FG000|Participant Flow|Sunitinib|Participants received sunitinib at a dose of 50 milligrams (mg) administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD) as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790066|NCT02420821|FG001|Participant Flow|Atezolizumab + Bevacizumab|Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 milligrams per kilogram (mg/kg) administered via intravenous (IV) infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790067|NCT02420821|OG000|Outcome|Sunitinib|Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790068|NCT02420821|OG001|Outcome|Atezolizumab + Bevacizumab|Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790069|NCT02420821|OG000|Outcome|Atezolizumab + Bevacizumab|Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790070|NCT02420821|EG000|Reported Event|Sunitinib|Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790071|NCT02420821|EG001|Reported Event|Atezolizumab + Bevacizumab|Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
10790072|NCT02412670|BG000|Baseline|Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)|Patients receive methotrexate IV over 2-3 minutes, vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV over 4 hours on day 1. Pegfilgrastim at 6 mg is given once 24-48 hours after completion of chemotherapy. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790073|NCT02412670|BG001|Baseline|Arm B (Gemcitabine, Carboplatin)|Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790074|NCT02412670|BG002|Baseline|Total|Total of all reporting groups
10790075|NCT02412670|FG000|Participant Flow|Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)|Patients receive methotrexate IV over 2-3 minutes, vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV over 4 hours on day 1. Pegfilgrastim at 6 mg is given once 24-48 hours after completion of chemotherapy. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790076|NCT02412670|FG001|Participant Flow|Arm B (Gemcitabine, Carboplatin)|Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790077|NCT02412670|OG000|Outcome|Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)|Patients receive methotrexate IV over 2-3 minutes, vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV over 4 hours on day 1. Pegfilgrastim at 6 mg is given once 24-48 hours after completion of chemotherapy. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10966678|NCT00888329|BG000|Baseline|Aprepitant|40 mg aprepitant
10966679|NCT00888329|BG001|Baseline|Placebo|Placebo
10966680|NCT00888329|BG002|Baseline|Total|Total of all reporting groups
10966681|NCT00888329|FG000|Participant Flow|Aprepitant|40 mg aprepitant
11195083|NCT02155881|FG000|Participant Flow|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
11195084|NCT02155881|FG001|Participant Flow|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
11195085|NCT02155881|OG000|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
10790078|NCT02412670|OG001|Outcome|Arm B (Gemcitabine, Carboplatin)|Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790079|NCT02412670|EG000|Reported Event|Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)|Patients receive methotrexate IV over 2-3 minutes, vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV over 4 hours on day 1. Pegfilgrastim at 6 mg is given once 24-48 hours after completion of chemotherapy. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790080|NCT02412670|EG001|Reported Event|Arm B (Gemcitabine, Carboplatin)|Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days after completion of chemotherapy.
10790081|NCT02410343|BG000|Baseline|Placebo|Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790082|NCT02410343|BG001|Baseline|TV-1106|TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790083|NCT02410343|BG002|Baseline|Total|Total of all reporting groups
10790084|NCT02410343|FG000|Participant Flow|Placebo|Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790085|NCT02410343|FG001|Participant Flow|TV-1106|TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790086|NCT02410343|OG000|Outcome|Placebo|Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790087|NCT02410343|OG001|Outcome|TV-1106|TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790088|NCT02410343|EG000|Reported Event|Placebo - Core Period|Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
11195086|NCT02155881|OG001|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
11195087|NCT02155881|EG000|Reported Event|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
11195088|NCT02155881|EG001|Reported Event|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
11195089|NCT02155985|BG000|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
11195090|NCT02155985|BG001|Baseline|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
11195091|NCT02155985|BG002|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
10966682|NCT00888329|FG001|Participant Flow|Placebo|Placebo
10966683|NCT00888329|OG000|Outcome|Aprepitant|40 mg aprepitant
11195092|NCT02155985|BG003|Baseline|Total|Total of all reporting groups
11195093|NCT02155985|FG000|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
10790089|NCT02410343|EG001|Reported Event|TV-1106 - Core Period|TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.
10790090|NCT02410343|EG002|Reported Event|TV-1106 - Extension Period|Participants from both the Placebo and TV-1106 groups who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106. Due to early termination of the study, two participants spent a maximum of two weeks in the extension period.
10790091|NCT02343224|BG000|Baseline|PEGINTRON|Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years
10790092|NCT02343224|FG000|Participant Flow|PEGINTRON|Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years
10790093|NCT02343224|OG000|Outcome|PEGINTRON|Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years
10790094|NCT02343224|EG000|Reported Event|PEGINTRON|Participants with juvenile pilocytic astrocytomas or optic pathway gliomas receiving PEGINTRON based on their weight (1 mcg/kg/dose) once a week, for up to two years
10790095|NCT02339740|BG000|Baseline|Standard Risk|WBC <10,000 cells/µL
10790096|NCT02339740|BG001|Baseline|High Risk|WBC ≥10,000 cells/µL
10790097|NCT02339740|BG002|Baseline|Total|Total of all reporting groups
10790098|NCT02339740|FG000|Participant Flow|Standard Risk|WBC <10,000 cells/µL
10790099|NCT02339740|FG001|Participant Flow|High Risk|WBC ≥10,000 cells/µL
10790100|NCT02339740|OG000|Outcome|Standard Risk|WBC <10,000 cells/µL
10790101|NCT02339740|OG000|Outcome|High Risk|WBC ≥10,000 cells/µL
10790102|NCT02339740|EG000|Reported Event|Standard Risk|WBC <10,000 cells/µL
10790103|NCT02339740|EG001|Reported Event|High Risk|WBC ≥10,000 cells/µL
10790104|NCT02291445|BG000|Baseline|Ileocolonic Release PO on First Test Day|"Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.~Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule): Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region."
11382852|NCT02865187|EG000|Reported Event|Vitamin D + Hormonal Contraception|"600IU/day Vitamin D + hormonal contraception~Vitamin D: Vitamin D 600IU/day~Hormonal contraception: Hormonal contraceptives"
10790105|NCT02291445|BG001|Baseline|Small Intestinal Release PO on First Test Day|"Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.~Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market."
10790106|NCT02291445|BG002|Baseline|Total|Total of all reporting groups
10790107|NCT02291445|FG000|Participant Flow|Ileocolonic Release PO First, Then Small-intestinal Release Peppermint Oil|"Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.~Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule): Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region."
10790108|NCT02291445|FG001|Participant Flow|Small Intestinal Release PO First, Then Ileocolonic Release Peppermint Oil|"Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.~Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market."
10790109|NCT02291445|OG000|Outcome|Ileocolonic Release PO|"Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.~Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule): Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region."
10790110|NCT02291445|OG001|Outcome|Small Intestinal Release PO|"Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.~Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market."
10790111|NCT02291445|OG000|Outcome|Ileocolonic Release PO First, Then Small-intestinal Release Peppermint Oil|"Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.~Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule): Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region."
10790112|NCT02291445|OG001|Outcome|Small Intestinal Release PO First, Then Ileocolonic Release Peppermint Oil|"Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.~Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market."
10790113|NCT02291445|EG000|Reported Event|Ileocolonic Release PO|"Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.~Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule): Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region."
10790114|NCT02291445|EG001|Reported Event|Small Intestinal Release PO|"Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.~Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market."
10790115|NCT02248688|BG000|Baseline|Embolic Agent - BeadBlock|"Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.~BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.~Left Gastric Artery Embolization"
10790116|NCT02248688|FG000|Participant Flow|BeadBlock 300 - 500 Micron Will be Used as the Embolic Agent to Embolize Left Gastric Artery.|Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
10790117|NCT02248688|OG000|Outcome|Embolic Agent - BeadBlock|"Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.~BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.~Left Gastric Artery Embolization"
10790118|NCT02248688|EG000|Reported Event|Embolic Agent - BeadBlock|"Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.~BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.~Left Gastric Artery Embolization"
10790119|NCT02045303|BG000|Baseline|Wound Age Between 4 and 21 Weeks|Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks or up to the time of wound closure.
10790120|NCT02045303|BG001|Baseline|Wound Age >=47 Weeks|Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks.
10790121|NCT02045303|BG002|Baseline|Total|Total of all reporting groups
10790122|NCT02045303|FG000|Participant Flow|Ambulatory Wound Clinic - Wound Age Between 4 and 21 Weeks|"Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.~Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.~Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.~Wound age between 4 and 21 weeks"
10790123|NCT02045303|FG001|Participant Flow|Ambulatory Wound Clinic - Wound Age Between 22 and 46 Weeks|"Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.~Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.~Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.~Wound age between 22 and 46 weeks"
10790124|NCT02045303|FG002|Participant Flow|Ambulatory Wound Clinic - Wound Age >= 47 Weeks|"Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.~Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.~Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.~Wound age >= 47 weeks"
10790125|NCT02045303|OG000|Outcome|Wound Age Between 4 and 21 Weeks|Wounds age between 4 and 21 weeks at the day of initial visit.
10790126|NCT02045303|OG001|Outcome|Wound Age >=47 Weeks|Wounds age >=47 weeks at the day of initial visit.
10790127|NCT02045303|OG000|Outcome|Wound Age Between 4 and 21 Weeks|Wounds with age between 4 and 21 weeks at the day of initial visit.
10790128|NCT02045303|OG001|Outcome|Wound Age >=47 Weeks|Wounds with age >= 47 weeks at the day of initial visit.
10790129|NCT02045303|OG001|Outcome|Wound Age >=47 Weeks|Wounds age between >=47 weeks at the day of initial visit.
10790130|NCT02045303|EG000|Reported Event|Wound Age Between 4 and 21 Weeks|Wounds age between 4 and 21 weeks
11195094|NCT02155985|FG001|Participant Flow|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
10790131|NCT02045303|EG001|Reported Event|Wound Age >=47 Weeks|Wounds age equal to or greater than 47 weeks
10790132|NCT02025556|BG000|Baseline|Placebo|"Participants received subcutaneous placebo injections at one visit per month for three months (Day~1/week 0, Day 29/week 4, and Day 57/week 8)."
10790133|NCT02025556|BG001|Baseline|Low Dose|Participants received 225 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790134|NCT02025556|BG002|Baseline|High Dose|Participants received 675 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790135|NCT02025556|BG003|Baseline|Total|Total of all reporting groups
10790136|NCT02025556|FG000|Participant Flow|Placebo|"Participants received subcutaneous placebo injections at one visit per month for three months (Day~1/week 0, Day 29/week 4, and Day 57/week 8)."
10790137|NCT02025556|FG001|Participant Flow|Low Dose|Participants received 225 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
11195095|NCT02155985|FG002|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
10790138|NCT02025556|FG002|Participant Flow|High Dose|Participants received 675 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790139|NCT02025556|OG000|Outcome|Placebo|"Participants received subcutaneous placebo injections at one visit per month for three months (Day~1/week 0, Day 29/week 4, and Day 57/week 8)."
10790140|NCT02025556|OG001|Outcome|Low Dose|Participants received 225 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790141|NCT02025556|OG002|Outcome|High Dose|Participants received 675 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790142|NCT02025556|EG000|Reported Event|Placebo|"Participants received subcutaneous placebo injections at one visit per month for three months (Day~1/week 0, Day 29/week 4, and Day 57/week 8)."
10790143|NCT02025556|EG001|Reported Event|Low Dose|Participants received 225 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
10790144|NCT02025556|EG002|Reported Event|High Dose|Participants received 675 mg fremanezumab subcutaneously on Day 1/week 0, Day 29/week 4, and on Day 57/week 8.
11195096|NCT02155985|OG000|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
10790145|NCT01986933|BG000|Baseline|Placebo (Part A)|"Data from patients randomized to this group in Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790146|NCT01986933|BG001|Baseline|Nemoliozumab (0.1 mg/kg) Q4W (Part A)|"Data from patients randomized to this group in Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790147|NCT01986933|BG002|Baseline|Nemoliozumab (0.5 mg/kg) Q4W (Part A)|"Data from patients randomized to this group in Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790148|NCT01986933|BG003|Baseline|Nemoliozumab (2.0 mg/kg) Q4W (Part A)|"Data from patients randomized to this group in Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790149|NCT01986933|BG004|Baseline|Nemoliozumab (2.0 mg/kg) Q8W (Part A)|"Data from patients randomized to this group in Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8."
10790150|NCT01986933|BG005|Baseline|Total|Total of all reporting groups
10790151|NCT01986933|FG000|Participant Flow|Placebo|"The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Placebo-to-active period (Part B ) (up to Week 64):~Patients randomized to placebo group in Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. Nemoliozumab was given subcutaneously every 4 weeks for 52 weeks. Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B."
10790152|NCT01986933|FG001|Participant Flow|Nemoliozumab (0.1 mg/kg) Q4W|"The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B ) (up to Week 64):~Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.~Placebo-to-active period (Part B) (up to Week 64):~Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B."
11382853|NCT02865187|EG001|Reported Event|Vit D + Non-hormonal Contraception|"600IU/day Vitamin D~Vitamin D: Vitamin D 600IU/day"
10790153|NCT01986933|FG002|Participant Flow|Nemoliozumab (0.5 mg/kg) Q4W|"The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B ) (up to Week 64):~Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.~Placebo-to-active period (Part B) (up to Week 64):~Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B."
10790154|NCT01986933|FG003|Participant Flow|Nemoliozumab (2.0 mg/kg) Q4W|"The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B ) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.~Placebo-to-active period (Part B) (up to Week 64):~Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B."
10790155|NCT01986933|FG004|Participant Flow|Nemoliozumab (2.0 mg/kg) Q8W|"The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.~Active-to-active period (Part B ) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.~Placebo-to-active period (Part B) (up to Week 64):~Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B."
10790156|NCT01986933|OG000|Outcome|Placebo (Part A)|"Data from Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10966684|NCT00888329|OG001|Outcome|Placebo|Placebo
10790157|NCT01986933|OG001|Outcome|Nemoliozumab (0.1 mg/kg) Q4W (Part A)|"Data from Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790158|NCT01986933|OG002|Outcome|Nemoliozumab (0.5 mg/kg) Q4W (Part A)|"Data from Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790159|NCT01986933|OG003|Outcome|Nemoliozumab (2.0 mg/kg) Q4W (Part A)|"Data from Part A were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790160|NCT01986933|OG000|Outcome|Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)|"Data from Part A and Part B were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790161|NCT01986933|OG001|Outcome|Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)|"Data from Part A and Part B were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790162|NCT01986933|OG002|Outcome|Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)|"Data from Part A and Part B were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790163|NCT01986933|OG003|Outcome|Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)|"Data from Part A and Part B were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790164|NCT01986933|EG000|Reported Event|Placebo (Part A)|"Data from Part A and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790165|NCT01986933|EG001|Reported Event|Nemoliozumab (0.1 mg/kg) Q4W (Part A)|"Data from Part A and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790166|NCT01986933|EG002|Reported Event|Nemoliozumab (0.5 mg/kg) Q4W (Part A)|"Data from Part A and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790167|NCT01986933|EG003|Reported Event|Nemoliozumab (2.0 mg/kg) Q4W (Part A)|"Data from Part A and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8."
10790168|NCT01986933|EG004|Reported Event|Nemoliozumab (2.0 mg/kg) Q8W (Part A)|"Data from Part A and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8."
10790169|NCT01986933|EG005|Reported Event|Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)|"Data from Part A, Part B and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790170|NCT01986933|EG006|Reported Event|Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)|"Data from Part A, Part B and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790171|NCT01986933|EG007|Reported Event|Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)|"Data from Part A, Part B and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10790172|NCT01986933|EG008|Reported Event|Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)|"Data from Part A, Part B and Safety Follow-up period were analyzed.~Placebo-controlled period (Part A) (Day 1 to Week 12):~Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.~Active-to-active period (Part B) (up to Week 64):~Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B."
10802480|NCT04399356|BG000|Baseline|Niclosamide|"Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)~Niclosamide: Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.~Telehealth monitoring: In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform."
10790173|NCT01986075|BG000|Baseline|Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)|"Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT"
10790174|NCT01986075|BG001|Baseline|Computer-assisted CBT Plus Placebo|"Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)"
10790175|NCT01986075|BG002|Baseline|Non-randomized Individuals|Patients who were enrolled in the initial 4 week period and received CBT + CM but were not eligible to be randomized and did not enter the second randomized period of the trial.
10790176|NCT01986075|BG003|Baseline|Total|Total of all reporting groups
10790177|NCT01986075|FG000|Participant Flow|Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)|"Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT"
10790178|NCT01986075|FG001|Participant Flow|Computer-assisted CBT Plus Placebo|"Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)"
10790179|NCT01986075|FG002|Participant Flow|Computer- Assisted CBT With Contingency Management|All participants received computer-assisted CBT with contingency management (CRA + CM) during the first 4 week period of the trial.
10790180|NCT01986075|OG000|Outcome|Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)|"Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT"
10966685|NCT00888329|EG000|Reported Event|Aprepitant|40 mg aprepitant
10966686|NCT00888329|EG001|Reported Event|Placebo|Placebo
11382854|NCT02836249|BG000|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
10966687|NCT00888381|BG000|Baseline|Adults|Healthy volunteers aged 18 to 59 years
11382855|NCT02836249|BG001|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
11382856|NCT02836249|BG002|Baseline|Total|Total of all reporting groups
10790181|NCT01986075|OG001|Outcome|Computer-assisted CBT Plus Placebo|"Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)"
10790182|NCT01986075|EG000|Reported Event|Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)|"Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Mixed amphetamine salts: 80 mg/day of Adderall-XR and computer -assisted CBT"
10790183|NCT01986075|EG001|Reported Event|Computer-assisted CBT Plus Placebo|"Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.~Computer-assisted behavior therapy: TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.~Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)"
10790184|NCT01986075|EG002|Reported Event|Non-randomized CBT Plus CM|Fifty nine individuals who were not randomized and only exposed to CBT and CM. 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention.
10790185|NCT01841333|BG000|Baseline|High Risk for Relapse Postallogeneic Stem Cell Transplant|AML and MDS patients at high risk for postallogeneic stem cell transplant relapse
10790186|NCT01841333|FG000|Participant Flow|PF-04449913|"Beginning 80 days after allogeneic stem cell transplant, patients receive PF-04449913 (100mg) orally once daily on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~PF-04449913: 100mg given orally"
10790187|NCT01841333|OG000|Outcome|PF-04449913|"Beginning 80 days after allogeneic stem cell transplant, patients receive PF-04449913 (100mg) orally once daily on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~PF-04449913: 100mg given orally"
10790188|NCT01841333|EG000|Reported Event|PF-04449913|"Beginning 80 days after allogeneic stem cell transplant, patients receive PF-04449913 (100mg) orally once daily on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~PF-04449913: 100mg given orally"
10790189|NCT01802788|BG000|Baseline|Cohort A|Patients implanted with a Portico valve after CE mark
10790190|NCT01802788|BG001|Baseline|Cohort B|Patients implanted in previous SJM-sponsored premarket studies
10790191|NCT01802788|BG002|Baseline|Total|Total of all reporting groups
10790192|NCT01802788|FG000|Participant Flow|Cohort A|Patients implanted with a Portico valve after CE mark
10790193|NCT01802788|FG001|Participant Flow|Cohort B|Patients implanted in previous SJM-sponsored premarket studies
10790194|NCT01802788|OG000|Outcome|Cohort A|Patients implanted with a Portico valve after CE mark
10790195|NCT01802788|EG000|Reported Event|Cohort A|Patients implanted with a Portico valve after CE mark
10965745|NCT00883558|FG002|Participant Flow|Insulin Lispro First, Then INSULIN-PH20 NP|"Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
10790200|NCT01563107|BG000|Baseline|Healthy Participants-Low Na+ Then High Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels
10790201|NCT01563107|BG001|Baseline|HealthyParticipants-HighNa+ Then Low Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels
10790202|NCT01563107|BG002|Baseline|Patients With POTS-Low Na+ Then High Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels
10790203|NCT01563107|BG003|Baseline|Patients With POTS-High Na+ Then Low Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels
10790204|NCT01563107|BG004|Baseline|Total|Total of all reporting groups
10790205|NCT01563107|FG000|Participant Flow|Healthy Participants-Low Na+ Then High Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with150 milliequivalent (mEq) sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
10790206|NCT01563107|FG001|Participant Flow|Healthy Participants-High Na+ Then Low Na+|Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0, and 1 day on diet with 150 milliequivalents (mEq) sodium/day,participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
10790207|NCT01563107|FG002|Participant Flow|Patients With POTS-Low Na+ Then High Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs,1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
10790208|NCT01563107|FG003|Participant Flow|Patients With POTS-High Na+ Then Low Na+|Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
10790209|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
10790210|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
10790211|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
10790212|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
10790213|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
10790214|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
10790215|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
10790216|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet."
10790217|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Supine and upright heart rate were measured on the 6th day of low sodium diet."
10966688|NCT00888381|BG001|Baseline|Older Adults|Healthy volunteers aged 60 years or older
10966689|NCT00888381|BG002|Baseline|Total|Total of all reporting groups
10790218|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Supine and upright heart rate were measured on the 6th day of high sodium diet."
10790219|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Supine and upright heart rate were measured on the 6th day of low sodium diet."
10790220|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Supine and upright heart rate were measured on the 6th day of high sodium diet."
10790221|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Upright symptoms were assessed on the 6th day of low sodium diet."
10790222|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Upright symptoms were assessed on the 6th day of high sodium diet."
10790223|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.~Upright symptoms were assessed on the 6th day of low sodium diet."
10790224|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|"Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.~Upright symptoms were assessed on the 6th day of high sodium diet."
10790225|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790226|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. . All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790227|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790228|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790229|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790230|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 2.
10790231|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 3."
10790232|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 3."
11382857|NCT02836249|FG000|Participant Flow|TAF 25 mg|Tenofovir alafenamide (TAF) 25 mg tablet + tenofovir disoproxil fumarate (TDF) placebo tablet once daily for up to 144 weeks
10790233|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 3."
11382858|NCT02836249|FG001|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
11382859|NCT02836249|OG000|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
10790234|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 3.
10790235|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 4."
10790236|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 4."
10790237|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 4."
10790238|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 4.
10790239|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 5."
10790240|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 5."
10790241|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 5."
10790242|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 5.
10790243|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 6."
10790244|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|"Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 6."
10790245|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|"Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet.~Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 6."
10790246|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Urine was collected daily for a 24hr period ending at approximately 8am.These results are for the urine collection which ended on Day 6.
10790247|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 3.
10790248|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 3.
10966690|NCT00888381|FG000|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
10966691|NCT00888381|FG001|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
10790249|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 3.
10790250|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 3.
10790251|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 4.
10790252|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 4.
10790253|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 4.
10790254|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 4.
10790255|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 5.
10790256|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 5.
11195097|NCT02155985|OG001|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
11382860|NCT02836249|OG001|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
10790257|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 5.
10790258|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 5.
10790259|NCT01563107|OG000|Outcome|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 6.
10790260|NCT01563107|OG001|Outcome|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 6.
10790261|NCT01563107|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 6.
10790262|NCT01563107|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels with low sodium or high sodium diet starting after 1 day of 150 mEq sodium/day. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the urine collection which ended on Day 6.
11382861|NCT02836249|EG000|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 144 weeks
11382862|NCT02836249|EG001|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks
11382863|NCT02829918|BG000|Baseline|Nivolumab Treatment|"This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.~Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study."
11382864|NCT02829918|FG000|Participant Flow|Nivolumab Treatment|"This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.~Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg every 4 weeks (Q4W) from 17 weeks to end of study."
11382865|NCT02829918|OG000|Outcome|Nivolumab Treatment|"This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.~Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study."
11382866|NCT02829918|EG000|Reported Event|Nivolumab Treatment|All participants receiving at least one dose of Nivolumab per protocol.
11382867|NCT02824198|BG000|Baseline|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
11382868|NCT02824198|BG001|Baseline|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
11382869|NCT02824198|BG002|Baseline|Total|Total of all reporting groups
11382870|NCT02824198|FG000|Participant Flow|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
11382871|NCT02824198|FG001|Participant Flow|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
11382872|NCT02824198|OG000|Outcome|CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28|Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).
11382873|NCT02824198|OG001|Outcome|CYD Dengue Vaccine Booster Group: Post Booster Dose|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
11382874|NCT02824198|OG000|Outcome|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
11382875|NCT02824198|OG001|Outcome|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
11382876|NCT02824198|EG000|Reported Event|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
11382877|NCT02824198|EG001|Reported Event|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
11382878|NCT02821754|BG000|Baseline|Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)|"RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382879|NCT02821754|BG001|Baseline|Radiofrequency Ablation/Cryoablation (RFA/CA)|"Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382880|NCT02821754|BG002|Baseline|Enrolled But Not Treated|Enrolled but not treated.
11382881|NCT02821754|BG003|Baseline|Total|Total of all reporting groups
11382882|NCT02821754|FG000|Participant Flow|Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)|"RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382883|NCT02821754|FG001|Participant Flow|Radiofrequency Ablation/Cryoablation (RFA/CA)|"Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382884|NCT02821754|FG002|Participant Flow|Enrolled But Not Treated|Enrolled but not treated.
10966692|NCT00888381|OG000|Outcome|Adults|Healthy volunteers aged 18 to 59 years
10966693|NCT00888381|OG001|Outcome|Older Adults|Healthy volunteers aged 60 years or older
11382885|NCT02821754|OG000|Outcome|Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)|"RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382886|NCT02821754|OG001|Outcome|Radiofrequency Ablation/Cryoablation (RFA/CA)|"Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382887|NCT02821754|EG000|Reported Event|Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)|"RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382888|NCT02821754|EG001|Reported Event|Radiofrequency Ablation/Cryoablation (RFA/CA)|"Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study.~30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation"
11382889|NCT02787551|BG000|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.
11382890|NCT02787551|BG001|Baseline|GLP-1 Receptor Agonist|GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
11382891|NCT02787551|BG002|Baseline|Total|Total of all reporting groups
11382892|NCT02787551|FG000|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|"Core period: FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.~Single arm extension period: participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted."
10790263|NCT01563107|EG000|Reported Event|Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
11195098|NCT02155985|OG002|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
11382893|NCT02787551|FG001|Participant Flow|GLP-1 Receptor Agonist|Core Period: GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
11382894|NCT02787551|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.
11382895|NCT02787551|OG001|Outcome|GLP-1 Receptor Agonist|GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
11382896|NCT02787551|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.
11382897|NCT02787551|OG000|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.
11382898|NCT02787551|EG000|Reported Event|Fixed Ratio Combination|FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted (median exposure: 183 days).
11382899|NCT02787551|EG001|Reported Event|GLP-1 Receptor Agonist|GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization (median exposure: 183 days).
11382900|NCT02787551|EG002|Reported Event|Fixed Ratio Combination Whole Study Period|Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted (median exposure: 365 days).
11382901|NCT02747121|BG000|Baseline|Control Before Intervention|"External inspection of health services. The intervention is external inspection of sepsis detection and treatment. The intervention is delivered on the organizational Level. Patient are not assigned to the intervention. The intervention is rolled out sequentially to 24 hospitals. We collect data at base line, before the inspections and 8 and 14 month after the inspections. The first arm is the Control period before the inspections.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11195099|NCT02155985|EG000|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
11195100|NCT02155985|EG001|Reported Event|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
11195101|NCT02155985|EG002|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
11195102|NCT02156076|BG000|Baseline|BMS-919373 3/2 mg|Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
11195103|NCT02156076|BG001|Baseline|BMS-919373 8/5 mg|Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
11195104|NCT02156076|BG002|Baseline|BMS-919373 20/12 mg|Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
11195105|NCT02156076|BG003|Baseline|Placebo|Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
11195106|NCT02156076|BG004|Baseline|Total|Total of all reporting groups
11195107|NCT02156076|FG000|Participant Flow|BMS-919373 3/2 mg|Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
11195108|NCT02156076|FG001|Participant Flow|BMS-919373 8/5 mg|Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
11195109|NCT02156076|FG002|Participant Flow|BMS-919373 20/12 mg|Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
11195110|NCT02156076|FG003|Participant Flow|Placebo|Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
11195111|NCT02156076|OG000|Outcome|BMS-919373 3/2 mg|Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
11195112|NCT02156076|OG001|Outcome|BMS-919373 8/5 mg|Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
11195113|NCT02156076|OG002|Outcome|BMS-919373 20/12 mg|Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
11195114|NCT02156076|OG003|Outcome|Placebo|Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
11195115|NCT02156076|EG000|Reported Event|Placebo|Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
11195116|NCT02156076|EG001|Reported Event|BMS-919373 3/2 mg|Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
11195117|NCT02156076|EG002|Reported Event|BMS-919373 8/5 mg|Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
11195118|NCT02156076|EG003|Reported Event|BMS-919373 20/12 mg|Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
11195119|NCT02156154|BG000|Baseline|Intravenous 0.9% Sodium Chloride|"0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195120|NCT02156154|BG001|Baseline|Intravenous Acetaminophen|"Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195121|NCT02156154|BG002|Baseline|Total|Total of all reporting groups
11195122|NCT02156154|FG000|Participant Flow|Intravenous 0.9% Sodium Chloride|"0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195123|NCT02156154|FG001|Participant Flow|Intravenous Acetaminophen|"Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195124|NCT02156154|OG000|Outcome|Intravenous Acetaminophen|"Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195125|NCT02156154|OG001|Outcome|Intravenous 0.9% Sodium Chloride|"0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
11195126|NCT02156154|EG000|Reported Event|Intravenous Acetaminophen|"Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
10790264|NCT01563107|EG001|Reported Event|Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B|Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
10790265|NCT01563107|EG002|Reported Event|Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.|Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
10790266|NCT01563107|EG003|Reported Event|Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet|Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
10790267|NCT01320072|BG000|Baseline|Aspirin-sensitive Asthmatics|patients with aspirin exacerbated respiratory disease
10790268|NCT01320072|BG001|Baseline|Aspirin-tolerant Asthmatics|aspirin-tolerant patients with asthma
10790269|NCT01320072|BG002|Baseline|Total|Total of all reporting groups
10790270|NCT01320072|FG000|Participant Flow|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
10790271|NCT01320072|FG001|Participant Flow|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
10790272|NCT01320072|OG000|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
10790273|NCT01320072|OG001|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
10790274|NCT01320072|OG000|Outcome|Aspirin-sensitive Asthmatics|Asthma patients with aspirin exacerbated respiratory disease
10790275|NCT01320072|EG000|Reported Event|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
10790276|NCT01320072|EG001|Reported Event|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
10790277|NCT01064479|BG000|Baseline|Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)|Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
10790278|NCT01064479|BG001|Baseline|Arm B (Combination Chemotherapy and Placebo)|Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
10790279|NCT01064479|BG002|Baseline|Total|Total of all reporting groups
10790280|NCT01064479|FG000|Participant Flow|Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)|Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
10790281|NCT01064479|FG001|Participant Flow|Arm B (Combination Chemotherapy and Placebo)|Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
10790282|NCT01064479|OG000|Outcome|Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)|Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
10790283|NCT01064479|OG001|Outcome|Arm B (Combination Chemotherapy and Placebo)|Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
10790284|NCT01064479|EG000|Reported Event|Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)|Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
10790285|NCT01064479|EG001|Reported Event|Arm B (Combination Chemotherapy and Placebo)|Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
10790286|NCT01042522|BG000|Baseline|Arm I (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10790287|NCT01042522|BG001|Baseline|Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)|"Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Bleomycin Sulfate: Given IV~Cisplatin: Given IV~Etoposide Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10790288|NCT01042522|BG002|Baseline|Total|Total of all reporting groups
10790289|NCT01042522|FG000|Participant Flow|Arm I (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10966694|NCT00888381|EG000|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
10966695|NCT00888381|EG001|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
10790290|NCT01042522|FG001|Participant Flow|Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)|"Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Bleomycin Sulfate: Given IV~Cisplatin: Given IV~Etoposide Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10790291|NCT01042522|OG000|Outcome|Arm I (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10790292|NCT01042522|OG001|Outcome|Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)|"Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Bleomycin Sulfate: Given IV~Cisplatin: Given IV~Etoposide Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10790293|NCT01042522|EG000|Reported Event|Arm I (Paclitaxel, Carboplatin)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV"
10790294|NCT01042522|EG001|Reported Event|Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)|"Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Bleomycin Sulfate: Given IV~Cisplatin: Given IV~Etoposide Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10790295|NCT00944528|BG000|Baseline|Single Dose Radiosurgery: Dose Level 1|"A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790296|NCT00944528|BG001|Baseline|Single Dose Radiosurgery: Dose Level 2|"A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790297|NCT00944528|BG002|Baseline|Single Dose Radiosurgery: Dose Level 3|"A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790298|NCT00944528|BG003|Baseline|Total|Total of all reporting groups
11195127|NCT02156154|EG001|Reported Event|Intravenous 0.9% Sodium Chloride|"0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.~Intravenous Acetaminophen"
10790299|NCT00944528|FG000|Participant Flow|Single Dose Radiosurgery: Dose Level 1|"A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790300|NCT00944528|FG001|Participant Flow|Single Dose Radiosurgery: Dose Level 2|"A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790301|NCT00944528|FG002|Participant Flow|Single Dose Radiosurgery: Dose Level 3|"A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
11195128|NCT02156167|BG000|Baseline|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
11195129|NCT02156167|FG000|Participant Flow|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
11195130|NCT02156167|OG000|Outcome|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
10790302|NCT00944528|OG000|Outcome|Single Dose Radiosurgery: All Dose Levels|A single dose of radiation in 15Gy (dose level 1), 18Gy (dose level 2) or 21Gy (dose level 3) given in radiosurgery technique about 10 days before lumpectomy.
10790303|NCT00944528|OG000|Outcome|Single Dose Radiosurgery: Dose Level 1|"A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790304|NCT00944528|OG001|Outcome|Single Dose Radiosurgery: Dose Level 2|"A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790305|NCT00944528|OG002|Outcome|Single Dose Radiosurgery: Dose Level 3|"A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790306|NCT00944528|EG000|Reported Event|Single Dose Radiosurgery: Dose Level 1|"A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790307|NCT00944528|EG001|Reported Event|Single Dose Radiosurgery: Dose Level 2|"A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy~Note: One participant in dose level 2 was killed in an unrelated motor vehicle accident and was not considered in all-cause mortality."
10790308|NCT00944528|EG002|Reported Event|Single Dose Radiosurgery: Dose Level 3|"A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.~Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy"
10790309|NCT00941915|BG000|Baseline|Stereotactic Radiotherapy|"Five fractions of 7.4 Gy each~SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days."
10790310|NCT00941915|FG000|Participant Flow|Stereotactic Radiotherapy|"Five fractions of 7.4 Gy each~SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days."
10790311|NCT00941915|OG000|Outcome|Stereotactic Radiotherapy|"Five fractions of 7.4 Gy each~SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days."
10790312|NCT00941915|EG000|Reported Event|Stereotactic Radiotherapy|"Five fractions of 7.4 Gy each~SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days."
10790313|NCT00826462|BG000|Baseline|Corticosteroid Injection in Combination With Physical Therapy|"Corticosteroid injection in combination with physical therapy~Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days~triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790314|NCT00826462|BG001|Baseline|Placebo Injection in Combination With Physical Therapy|"Placebo injection in combination with physical therapy~Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days~Placebo: Injection with sodium chloride at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790315|NCT00826462|BG002|Baseline|Control Group: Wait-and-see Treatment|"Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days~Naproxen: Naproxen 500 mg bid for 14 days"
10790316|NCT00826462|BG003|Baseline|Total|Total of all reporting groups
10790317|NCT00826462|FG000|Participant Flow|Corticosteroid Injection in Combination With Physical Therapy|"Corticosteroid injection in combination with physical therapy~Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days~triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790318|NCT00826462|FG001|Participant Flow|Placebo Injection in Combination With Physical Therapy|"Placebo injection in combination with physical therapy~Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days~Placebo: Injection with sodium chloride at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790319|NCT00826462|FG002|Participant Flow|Control Group: Wait-and-see Treatment|"Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days~Naproxen: Naproxen 500 mg bid for 14 days"
11195131|NCT02156167|EG000|Reported Event|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
10790320|NCT00826462|OG000|Outcome|Control Group: Wait-and-see Treatment|"Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days~Naproxen: Naproxen 500 mg bid for 14 days"
10790321|NCT00826462|OG001|Outcome|Placebo Injection in Combination With Physical Therapy|"Placebo injection in combination with physical therapy~Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days~Placebo: Injection with sodium chloride at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790322|NCT00826462|OG002|Outcome|Corticosteroid Injection in Combination With Physical Therapy|"Corticosteroid injection in combination with physical therapy~Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days~triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790323|NCT00826462|OG000|Outcome|Corticosteroid Injection in Combination With Physical Therapy|"Corticosteroid injection in combination with physical therapy~Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days~triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790324|NCT00826462|OG002|Outcome|Control Group: Wait-and-see Treatment|"Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days~Naproxen: Naproxen 500 mg bid for 14 days"
10790325|NCT00826462|EG000|Reported Event|Corticosteroid Injection in Combination With Physical Therapy|"Corticosteroid injection in combination with physical therapy~Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days~triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10965746|NCT00883558|OG000|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.
11382902|NCT02747121|BG001|Baseline|After Intervention (After Inspection)|"Patients included after intervention.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382903|NCT02747121|BG002|Baseline|Total|Total of all reporting groups
11382904|NCT02747121|FG000|Participant Flow|Intervention|"External inspection of health services. We compare the effect measures before and after the inspection. The intervention arm is data after the hospitals have received the inspection.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382905|NCT02747121|FG001|Participant Flow|Control Before Intervention|"External inspection of health services. The intervention is external inspection of sepsis detection and treatment. The intervention is delivered on the organizational Level. Patient are not assigned to the intervention. The intervention is rolled out sequentially to 24 hospitals. We collect data at base line, before the inspections and 8 and 14 month after the inspections. The first arm is the Control period before the inspections.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382906|NCT02747121|OG000|Outcome|Intervention|"External inspection of health services. We compare the effect measures before and after the inspection. The intervention arm is data after the hospitals have received the inspection.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382907|NCT02747121|OG001|Outcome|Control Before Intervention|"External inspection of health services. The intervention is external inspection of sepsis detection and treatment. The intervention is delivered on the organizational Level. Patient are not assigned to the intervention. The intervention is rolled out sequentially to 24 hospitals. We collect data at base line, before the inspections and 8 and 14 month after the inspections. The first arm is the Control period before the inspections.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382908|NCT02747121|EG000|Reported Event|Intervention|"External inspection of health services. We compare the effect measures before and after the inspection. The intervention arm is data after the hospitals have received the inspection.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11195132|NCT02156258|BG000|Baseline|Diagnostic Cases|"Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195133|NCT02156258|BG001|Baseline|Recall Cases|"Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
10965747|NCT00883558|OG001|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.
10790326|NCT00826462|EG001|Reported Event|Placebo Injection in Combination With Physical Therapy|"Placebo injection in combination with physical therapy~Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days~Placebo: Injection with sodium chloride at start and at 3 weeks~Lidocaine: 10 mg of lidocaine at start and at 3 weeks~Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises~Naproxen: Naproxen 500 mg bid for 14 days"
10790327|NCT00826462|EG002|Reported Event|Control Group: Wait-and-see Treatment|"Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days~Naproxen: Naproxen 500 mg bid for 14 days"
10790328|NCT00710970|BG000|Baseline|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
10790329|NCT00710970|FG000|Participant Flow|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
10790330|NCT00710970|OG000|Outcome|Single Arm Receiving 25mg Tamoxifen|Tamoxifen: Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
10790331|NCT00710970|EG000|Reported Event|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
10790332|NCT00685919|BG000|Baseline|Healthy Participants-Placebo Then Carbidopa|Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
10790333|NCT00685919|BG001|Baseline|Healthy Participants-Carbidopa Then Placebo|Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
10790334|NCT00685919|BG002|Baseline|Patients With POTS-Placebo Then Carbidopa|Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
10790335|NCT00685919|BG003|Baseline|POTS-Carbidopa Then Placebo|Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
10790336|NCT00685919|BG004|Baseline|Total|Total of all reporting groups
10790337|NCT00685919|FG000|Participant Flow|Healthy Participants-Placebo Then Carbidopa|Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
10790338|NCT00685919|FG001|Participant Flow|Healthy Participants-Carbidopa Then Placebo|Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
10790339|NCT00685919|FG002|Participant Flow|Patients With POTS-Placebo Then Carbidopa|Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
10790340|NCT00685919|FG003|Participant Flow|Patients With POTS-Carbidopa Then Placebo|Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
10790341|NCT00685919|OG000|Outcome|Healthy Participants Who Received Placebo as Treatment A or Treatment B|Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
10790342|NCT00685919|OG001|Outcome|Healthy Participants Who Received Carbidopa as Treatment A or Treatment B|Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
10790343|NCT00685919|OG002|Outcome|Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B|POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
10790344|NCT00685919|OG003|Outcome|Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B|POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
10790345|NCT00685919|EG000|Reported Event|Healthy Participants-Placebo|Placebo matching carbidopa given every 6 hours orally for 5 doses
10790346|NCT00685919|EG001|Reported Event|Healthy Participants-Carbidopa|Carbidopa 200 mg every 6 hours orally for 5 doses
10790347|NCT00685919|EG002|Reported Event|POTS Participants-Placebo|Placebo matching carbidopa given every 6 hours orally for 5 doses
10790348|NCT00685919|EG003|Reported Event|POTS Participants-Carbidopa|Carbidopa 200 mg every 6 hours orally for 5 doses
10790349|NCT00344487|BG000|Baseline|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
10790350|NCT00344487|FG000|Participant Flow|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
10790351|NCT00344487|OG000|Outcome|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
10790352|NCT00344487|OG000|Outcome|Kaletra|lopinavir/ritonavir 400/100mg tablets by mouth twice a day for 48 weeks
10790353|NCT00344487|OG000|Outcome|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
10790354|NCT00344487|EG000|Reported Event|Kaletra|lopinavir/ritonavir 400/100mg tablets by mouth twice a day for 48 weeks
10790355|NCT00281658|BG000|Baseline|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
10790356|NCT00281658|BG001|Baseline|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
10790357|NCT00281658|BG002|Baseline|Total|Total of all reporting groups
10790358|NCT00281658|FG000|Participant Flow|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
10790359|NCT00281658|FG001|Participant Flow|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
10790360|NCT00281658|FG002|Participant Flow|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily
10790361|NCT00281658|OG000|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
10790362|NCT00281658|OG001|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
11382909|NCT02747121|EG001|Reported Event|Control Before Intervention|"External inspection of health services. The intervention is external inspection of sepsis detection and treatment. The intervention is delivered on the organizational Level. Patient are not assigned to the intervention. The intervention is rolled out sequentially to 24 hospitals. We collect data at base line, before the inspections and 8 and 14 month after the inspections. The first arm is the Control period before the inspections.~External inspection of health services: The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole."
11382910|NCT02735044|BG000|Baseline|HOE901-U300|Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
11195134|NCT02156258|BG002|Baseline|Screening Cases|"Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195135|NCT02156258|BG003|Baseline|Total|Total of all reporting groups
11195136|NCT02156258|FG000|Participant Flow|Diagnostic Cases|"Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195137|NCT02156258|FG001|Participant Flow|Recall Cases|"Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195138|NCT02156258|FG002|Participant Flow|Screening Cases|"Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11382911|NCT02735044|BG001|Baseline|Lantus|Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
11382912|NCT02735044|BG002|Baseline|Total|Total of all reporting groups
11382913|NCT02735044|FG000|Participant Flow|HOE901-U300|Insulin glargine 300 Units/milliliter (U/mL) subcutaneous (SC) injection once daily in the morning or evening for 12 months.
11382914|NCT02735044|FG001|Participant Flow|Lantus|Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
11382915|NCT02735044|OG000|Outcome|HOE901-U300|Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
11382916|NCT02735044|OG001|Outcome|Lantus|Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
11382917|NCT02735044|EG000|Reported Event|HOE901-U300|Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
11382918|NCT02735044|EG001|Reported Event|Lantus|Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
11382919|NCT02720744|BG000|Baseline|FT218|Patients treated with FT218, once nightly sodium oxybate granules for oral suspension.
11382920|NCT02720744|BG001|Baseline|Placebo|Matching Placebo
11382921|NCT02720744|BG002|Baseline|Total|Total of all reporting groups
11382922|NCT02720744|FG000|Participant Flow|FT218|Patients treated with FT218, once nightly sodium oxybate granules for oral suspension
11382923|NCT02720744|FG001|Participant Flow|Placebo|Matching Placebo
11382924|NCT02720744|OG000|Outcome|FT218|Patients treated with FT218, once nightly sodium oxybate granules for oral suspension
11382925|NCT02720744|OG001|Outcome|Placebo|Matching Placebo
11382926|NCT02720744|EG000|Reported Event|FT218 9g Group|Patients treated with FT218 who completed the 9g dosing period
11382927|NCT02720744|EG001|Reported Event|Placebo 9g Group|Patients treated with FT218 who completed the 9g dosing period
11382928|NCT02713867|BG000|Baseline|Treatment A|Nivolumab 480mg Q4W
11195139|NCT02156258|OG000|Outcome|Diagnostic Cases|"Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11382929|NCT02713867|BG001|Baseline|Treatment B|Nivolumab 240mg Q2W
11382930|NCT02713867|BG002|Baseline|Total|Total of all reporting groups
11382931|NCT02713867|FG000|Participant Flow|Treatment A|Nivolumab 480mg Q4W
11382932|NCT02713867|FG001|Participant Flow|Treatment B|Nivolumab 240mg Q2W
11382933|NCT02713867|OG000|Outcome|Treatment A|Nivolumab 480mg Q4W
11382934|NCT02713867|OG001|Outcome|Treatment B|Nivolumab 240mg Q2W
11382935|NCT02713867|EG000|Reported Event|Treatment A|Nivolumab 480mg Q4W
11382936|NCT02713867|EG001|Reported Event|Treatment B|Nivolumab 240mg Q2W
11382937|NCT02704403|BG000|Baseline|120 mg Elafibranor|Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
11382938|NCT02704403|BG001|Baseline|Placebo|Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
11382939|NCT02704403|BG002|Baseline|Total|Total of all reporting groups
11382940|NCT02704403|FG000|Participant Flow|120 mg Elafibranor|Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
11382941|NCT02704403|FG001|Participant Flow|Placebo|Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
11382942|NCT02704403|OG000|Outcome|120 mg Elafibranor|Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
11382943|NCT02704403|OG001|Outcome|Placebo|Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
11382944|NCT02704403|EG000|Reported Event|120 mg Elafibranor|Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water
11195140|NCT02156258|OG001|Outcome|Recall Cases|"Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195141|NCT02156258|OG002|Outcome|Screening Cases|"Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11382945|NCT02704403|EG001|Reported Event|Placebo|Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
11382946|NCT02694185|BG000|Baseline|Experimental Group|"This group will undergo the intervention as described in the protocol~Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient."
11382947|NCT02694185|BG001|Baseline|Control Group|This group will not receive the intervention, they will receive usual care
11382948|NCT02694185|BG002|Baseline|Total|Total of all reporting groups
11382949|NCT02694185|FG000|Participant Flow|Experimental Group|"This group will undergo the intervention as described in the protocol~Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient."
11382950|NCT02694185|FG001|Participant Flow|Control Group|This group will not receive the intervention, they will receive usual care
11382951|NCT02694185|OG000|Outcome|Experimental Group|"This group will undergo the intervention as described in the protocol~Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient."
11382952|NCT02694185|OG001|Outcome|Control Group|This group will not receive the intervention, they will receive usual care
11382953|NCT02694185|EG000|Reported Event|Experimental Group|"This group will undergo the intervention as described in the protocol~Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient."
11382954|NCT02694185|EG001|Reported Event|Control Group|This group will not receive the intervention, they will receive usual care
11382955|NCT02692651|BG000|Baseline|Fidaxomicin|Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
11382956|NCT02692651|BG001|Baseline|Vancomycin|Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
11382957|NCT02692651|BG002|Baseline|Total|Total of all reporting groups
11382958|NCT02692651|FG000|Participant Flow|Vancomycin|Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
11382959|NCT02692651|FG001|Participant Flow|Fidaxomicin|Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
11382960|NCT02692651|OG000|Outcome|Fidaxomicin|Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
11195142|NCT02156258|EG000|Reported Event|Diagnostic Cases|"Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195143|NCT02156258|EG001|Reported Event|Recall Cases|"Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
11195144|NCT02156258|EG002|Reported Event|Screening Cases|"Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography~FFDM Mammography: Standard mammography image collection~DBT Mammography: Collection of breast images using DBT mammography"
10790363|NCT00281658|EG000|Reported Event|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
10790364|NCT00281658|EG001|Reported Event|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
10790365|NCT00281658|EG002|Reported Event|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
10802481|NCT04399356|BG001|Baseline|Control|"Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)~Placebo: The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.~Telehealth monitoring: In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform."
10802482|NCT04399356|BG002|Baseline|Total|Total of all reporting groups
10802483|NCT04399356|FG000|Participant Flow|Niclosamide- Experimental Group|Participants received Niclosamide 2 grams by mouth daily for 7 days.
10802484|NCT04399356|FG001|Participant Flow|Control Group|Participants received placebo using the same dosing schedule as Experimental Group
10802485|NCT04399356|OG000|Outcome|Niclosamide- Experimental Group|Participants received Niclosamide 2 grams by mouth daily for 7 days.
10802486|NCT04399356|OG001|Outcome|Control Group|Participants received placebo using the same dosing schedule as Experimental Group
11195145|NCT02156271|BG000|Baseline|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
10802487|NCT04399356|EG000|Reported Event|Niclosamide- Experimental Group|Participants received Niclosamide 2 grams by mouth daily for 7 days.
10802488|NCT04399356|EG001|Reported Event|Control Group|Participants received placebo using the same dosing schedule as Experimental Group
10803873|NCT01410890|EG001|Reported Event|Alglucosidase Alfa: >=18 Years|Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached.
10803883|NCT01190228|BG000|Baseline|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
10803884|NCT01190228|BG001|Baseline|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
10803885|NCT01190228|BG002|Baseline|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
10803886|NCT01190228|BG003|Baseline|Total|Total of all reporting groups
10803887|NCT01190228|FG000|Participant Flow|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
10803888|NCT01190228|FG001|Participant Flow|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
11195146|NCT02156271|BG001|Baseline|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
11195147|NCT02156271|BG002|Baseline|Total|Total of all reporting groups
11195148|NCT02156271|FG000|Participant Flow|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
11195149|NCT02156271|FG001|Participant Flow|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
10790366|NCT04368910|BG000|Baseline|Pyronaridine - Artesunate|"Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.~For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy.~Pyronaridine - artesunate: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days."
10790367|NCT04368910|BG001|Baseline|Chloroquine|"Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.~For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy.~Chloroquine: Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days."
10790368|NCT04368910|BG002|Baseline|Total|Total of all reporting groups
10790369|NCT04368910|FG000|Participant Flow|Pyronaridine - Artesunate|Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
10790370|NCT04368910|FG001|Participant Flow|Chloroquine|Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
10790371|NCT04368910|OG000|Outcome|Pyronaridine - Artesunate|Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
10790372|NCT04368910|OG001|Outcome|Chloroquine|Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
10790373|NCT04368910|EG000|Reported Event|Pyronaridine - Artesunate|Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
10790374|NCT04368910|EG001|Reported Event|Chloroquine|Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
10790375|NCT04365985|BG000|Baseline|Placebo|"Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790376|NCT04365985|BG001|Baseline|Naltrexone|"Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.."
10790377|NCT04365985|BG002|Baseline|Ketamine|"Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790378|NCT04365985|BG003|Baseline|Total|Total of all reporting groups
11195150|NCT02156271|OG000|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
10790379|NCT04365985|FG000|Participant Flow|Placebo|"Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790380|NCT04365985|FG001|Participant Flow|Naltrexone|"Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.."
10790381|NCT04365985|FG002|Participant Flow|Ketamine|"Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790382|NCT04365985|OG000|Outcome|Placebo|"Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790383|NCT04365985|OG001|Outcome|Naltrexone|"Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.."
10790384|NCT04365985|OG002|Outcome|Ketamine|"Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790385|NCT04365985|EG000|Reported Event|Placebo|"Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10790386|NCT04365985|EG001|Reported Event|Naltrexone|"Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.."
10790387|NCT04365985|EG002|Reported Event|Ketamine|"Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.~Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .~Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm."
10802489|NCT04350905|BG000|Baseline|Mosquito Feeding|"Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes.~Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications."
10802490|NCT04350905|FG000|Participant Flow|Mosquito Feeding|"Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes.~Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications."
10802491|NCT04350905|OG000|Outcome|Mosquito Feeding|"Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes.~Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications."
10802492|NCT04350905|EG000|Reported Event|Mosquito Feeding|"Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes.~Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications."
10802493|NCT04236635|BG000|Baseline|CCH Subcutaneous Injection|Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique.
10802494|NCT04236635|FG000|Participant Flow|Group 1: Collagenase Clostridium Histolyticum (CCH) Single Injection Technique|"Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique.~Each participant had 2 marked areas of the abdomen (Area 1 and Area 2) selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
10802495|NCT04236635|FG001|Participant Flow|Group 2: CCH Single Injection Technique|"Participants were administered 0.07 mg CCH subcutaneously using a single injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3."
10802496|NCT04236635|FG002|Participant Flow|Group 3: CCH Single Injection Technique|Participants were administered 0.07 mg CCH using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
10802497|NCT04236635|FG003|Participant Flow|Group 4: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
11195151|NCT02156271|OG001|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
11195152|NCT02156271|EG000|Reported Event|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
11195153|NCT02156271|EG001|Reported Event|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
11195154|NCT02156466|BG000|Baseline|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195155|NCT02156466|BG001|Baseline|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
10790388|NCT04034355|BG000|Baseline|PledOx (5 µmol/kg)|"Calmangafodipir 5 µmol/kg~Calmangafodipir (5 µmol/kg): PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials."
10790389|NCT04034355|BG001|Baseline|Placebo|"0.9% sodium chloride in 20 mL vials~Placebo: Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials."
10790390|NCT04034355|BG002|Baseline|Total|Total of all reporting groups
10965748|NCT00883558|EG000|Reported Event|INSULIN-PH20 NP Treatment Period|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.
11195156|NCT02156466|BG002|Baseline|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195157|NCT02156466|BG003|Baseline|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195158|NCT02156466|BG004|Baseline|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195159|NCT02156466|BG005|Baseline|Total|Total of all reporting groups
10790391|NCT04034355|FG000|Participant Flow|PledOx (5 µmol/kg)|"Calmangafodipir 5 µmol/kg~Calmangafodipir (5 µmol/kg): PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials."
11195160|NCT02156466|FG000|Participant Flow|MSB0010841 30 mg|MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195161|NCT02156466|FG001|Participant Flow|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195162|NCT02156466|FG002|Participant Flow|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195163|NCT02156466|FG003|Participant Flow|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195164|NCT02156466|FG004|Participant Flow|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
10790392|NCT04034355|FG001|Participant Flow|Placebo|"0.9% sodium chloride in 20 mL vials~Placebo: Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials."
10790393|NCT04034355|OG000|Outcome|PledOx (5 µmol/kg)|"Calmangafodipir 5 µmol/kg~Calmangafodipir (5 µmol/kg): PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials."
10790394|NCT04034355|OG001|Outcome|Placebo|"0.9% sodium chloride in 20 mL vials~Placebo: Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials."
10790395|NCT04034355|EG000|Reported Event|PledOx (5 µmol/kg)|"Calmangafodipir 5 µmol/kg~Calmangafodipir (5 µmol/kg): PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials."
10790396|NCT04034355|EG001|Reported Event|Placebo|"0.9% sodium chloride in 20 mL vials~Placebo: Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials."
10790397|NCT03781726|BG000|Baseline|NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)|"8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir~glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet."
10966696|NCT00888433|BG000|Baseline|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
11195165|NCT02156466|OG000|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195166|NCT02156466|OG001|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195167|NCT02156466|OG002|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195168|NCT02156466|OG003|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195169|NCT02156466|OG004|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195170|NCT02156466|OG000|Outcome|MSB0010841 Combined|All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks
11195171|NCT02156466|OG001|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195172|NCT02156466|OG000|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
10790398|NCT03781726|FG000|Participant Flow|NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)|"8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir~glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet."
10790399|NCT03781726|OG000|Outcome|NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)|"8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir~glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet."
10790400|NCT03781726|EG000|Reported Event|NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)|"8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir~glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet."
10790401|NCT03721276|BG000|Baseline|Therapy|"Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.~EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse."
10790402|NCT03721276|BG001|Baseline|Waitlist|Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
10790403|NCT03721276|BG002|Baseline|Total|Total of all reporting groups
10790404|NCT03721276|FG000|Participant Flow|Therapy|"Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.~EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse."
10790405|NCT03721276|FG001|Participant Flow|Waitlist|Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
10790406|NCT03721276|OG000|Outcome|Therapy|"Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.~EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse."
10790407|NCT03721276|OG001|Outcome|Waitlist|Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
10790408|NCT03721276|EG000|Reported Event|Therapy|"Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after randomization, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.~EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse."
10790409|NCT03721276|EG001|Reported Event|Waitlist|Individuals assigned to waitlist will be put on a waitlist for 3 months after randomization, after which they will also receive the same treatment as the therapy group.
10790410|NCT03700658|BG000|Baseline|Overall Study|Participants received TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) and TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation, Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation, and TV-46046 placebo SC injection in a crossover design. The 4 study drug injections were administered approximately 1 hour apart.
10790411|NCT03700658|FG000|Participant Flow|Overall Study|Participants received TV-46046 undiluted (120 milligrams [mg]/0.3 milliliters [mL] of 400 mg/mL) and TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) subcutaneous (SC) injection as a test formulation, Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation, and TV-46046 placebo SC injection in a crossover design. The 4 study drug injections were administered approximately 1 hour apart.
10790412|NCT03700658|OG000|Outcome|TV-46046 Undiluted|Participants received TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) subcutaneous (SC) injection as a test formulation.
10790413|NCT03700658|OG001|Outcome|TV-46046 Diluted|Participants received TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation.
10790414|NCT03700658|OG002|Outcome|TV-46046 Placebo|Participants received TV-46046 placebo (0.3 mL) SC injection.
10790415|NCT03700658|OG003|Outcome|Depo-subQ 104|Participants received Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation.
10790416|NCT03700658|OG000|Outcome|TV-46046 Undiluted|Participants received TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation.
10790417|NCT03700658|OG000|Outcome|Overall Study|Participants received TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) and TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation, Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation, and TV-46046 placebo SC injection in a crossover design. The 4 study drug injections were administered approximately 1 hour apart.
10790418|NCT03700658|EG000|Reported Event|Follow-up After Treatment|All Participants were followed for at least 6 months after receiving their injections. Participants with unresolved injection site reactions (ISRs) were followed monthly through the resolution of ISRs or Month 18, whichever came first.
10790419|NCT03700658|EG001|Reported Event|TV-46046 Undiluted|Participants received TV-46046 undiluted (120mg/0.3 mL of 400 mg/mL) SC injection as a test formulation.
10790420|NCT03700658|EG002|Reported Event|TV-46046 Diluted|Participants received TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation.
10790421|NCT03700658|EG003|Reported Event|TV-46046 Placebo|Participants received TV-46046 placebo SC injection.
10790422|NCT03700658|EG004|Reported Event|Depo-subQ 104|Participants received Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation.
10790423|NCT03637491|BG000|Baseline|Avelumab+Binimetinib 30mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 30 mg BID orally on a continuous daily dosing schedule.
10790424|NCT03637491|BG001|Baseline|Avelumab+Binimetinib 45mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 45 mg BID orally on a continuous daily dosing schedule.
10790425|NCT03637491|BG002|Baseline|Binimetinib 30mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 30 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790426|NCT03637491|BG003|Baseline|Binimetinib 45mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 45 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790427|NCT03637491|BG004|Baseline|Total|Total of all reporting groups
10790428|NCT03637491|FG000|Participant Flow|Avelumab+Binimetinib 30mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg every 2 weeks (Q2W) in combination with binimetinib at 30 mg twice daily (BID) orally on a continuous daily dosing schedule.
10790429|NCT03637491|FG001|Participant Flow|Avelumab+Binimetinib 45mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 45 mg BID orally on a continuous daily dosing schedule.
10790430|NCT03637491|FG002|Participant Flow|Binimetinib 30mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 30 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790431|NCT03637491|FG003|Participant Flow|Binimetinib 45mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 45 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790432|NCT03637491|OG000|Outcome|Avelumab+Binimetinib 30mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 30 mg BID orally on a continuous daily dosing schedule.
10790433|NCT03637491|OG001|Outcome|Avelumab+Binimetinib 45mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 45 mg BID orally on a continuous daily dosing schedule.
10790434|NCT03637491|OG002|Outcome|Binimetinib 30mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 30 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790435|NCT03637491|OG003|Outcome|Binimetinib 45mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 45 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790436|NCT03637491|OG000|Outcome|Avelumab Binimetinib and Talazoparib|Since phase 2 was not initiated, the dose and details of arm haven't been confirmed.
10790437|NCT03637491|OG000|Outcome|Binimetinib 30mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 30 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790438|NCT03637491|OG001|Outcome|Binimetinib 45mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 45 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790439|NCT03637491|EG000|Reported Event|Avelumab+Binimetinib 30mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 30 mg BID orally on a continuous daily dosing schedule.
10790440|NCT03637491|EG001|Reported Event|Avelumab+Binimetinib 45mg (Phase 1b)|Avelumab was administered at a fixed dose of 800 mg Q2W in combination with binimetinib at 45 mg BID orally on a continuous daily dosing schedule.
11195173|NCT02156466|OG000|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195174|NCT02156466|OG000|Outcome|MSB0010841 30 mg|MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.
10790441|NCT03637491|EG002|Reported Event|Binimetinib 30mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 30 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790442|NCT03637491|EG003|Reported Event|Binimetinib 45mg+Talazoparib 0.75mg (Phase 1b)|Binimetinib 45 mg was administered orally BID (7 days on / 7 days off) with talazoparib at 0.75 mg once daily (QD) orally on a continuous dosing schedule.
10790443|NCT03610334|BG000|Baseline|Cohort 1: SAD IFB-088 2.5mg|a single daily dose of 2.5mg IFB-088 in oral capsule, is administered in the morning (8:00am), in one intake
10790444|NCT03610334|BG001|Baseline|Cohort 2: SAD IFB-088 5.0mg|a single daily dose of 5.0mg IFB-088 in oral capsule, divided into 2 doses of 2.5mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790445|NCT03610334|BG002|Baseline|Cohort 3: SAD IFB-088 10.0mg|a single daily dose of 10.0mg IFB-088 in oral capsule, divided into 2 doses of 5.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790446|NCT03610334|BG003|Baseline|Cohort 4: SAD IFB-088 20.0mg|a single daily dose of 20.0mg IFB-088 in oral capsule, divided into 2 doses of 10.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790447|NCT03610334|BG004|Baseline|Cohort 5: SAD IFB-088 40.0mg|a single daily dose of 40.0mg IFB-088 in oral capsule, divided into 2 doses of 20.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790448|NCT03610334|BG005|Baseline|Cohort 6: SAD IFB-088 60.0mg|a single daily dose of 60.0mg IFB-088 in oral capsule, divided into 2 doses of 30.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790449|NCT03610334|BG006|Baseline|Cohort 7: MAD IFB-088 15.0mg|subject taking 15.0mg of IFB-088 in oral capsule, divided into 2 doses of 7.5mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days
10803889|NCT01190228|FG002|Participant Flow|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
11195175|NCT02156466|OG001|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.
11195176|NCT02156466|OG002|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.
10790450|NCT03610334|BG007|Baseline|Cohort 8: MAD IFB-088 30.0mg|subject taking 30.0mg of IFB-088 in oral capsule, divided into 2 doses of 15.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days
10790451|NCT03610334|BG008|Baseline|Cohort 9: MAD IFB-088 50.0mg|subject taking 50.0mg of IFB-088 in oral capsule, divided into 2 doses of 25.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days
10790452|NCT03610334|BG009|Baseline|SAD Placebo Group|a single daily dose of placebo in oral capsule, divided into 1 or 2 doses equivalent to verum, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)
10790453|NCT03610334|BG010|Baseline|MAD Placebo Group|subject taking placebo equivalent to the verum dose in oral capsule, divided into 2 doses , separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days
10790454|NCT03610334|BG011|Baseline|Total|Total of all reporting groups
10790455|NCT03610334|FG000|Participant Flow|SAD IFB-088 2.5 mg|A single daily dose of IFB-088 2.5 mg is administered to 6 healthy volunteers
10790456|NCT03610334|FG001|Participant Flow|SAD Placebo 2.5mg|A single daily dose of placebo (microcristalline cellusose) 2.5 mg is administered to 2 healthy volunteers
10790457|NCT03610334|FG002|Participant Flow|SAD IFB-088 5.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of IFB-088 5.0 mg is administered to 6 healthy volunteers, in two intakes of 2.5mg, separated by 12h."
10790458|NCT03610334|FG003|Participant Flow|SAD Placebo 5.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of placebo (microcrystalline cellulose) 5.0 mg is administered to 2 healthy volunteers, in two intakes of 2.5mg, separated by 12h."
10790459|NCT03610334|FG004|Participant Flow|SAD IFB-088 10.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of IFB-088 10.0 mg is administered to 6 healthy volunteers, in two intakes of 5.0mg, separated by 12h."
10790460|NCT03610334|FG005|Participant Flow|SAD Placebo 10.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of placebo (microcrystalline cellusose) 10.0 mg is administered to 2 healthy volunteers, in two intakes of 5.0mg, separated by 12h."
10790461|NCT03610334|FG006|Participant Flow|SAD IFB-088 20.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of IFB-088 20.0 mg is administered to 6 healthy volunteers, in two intakes of 10.0mg, separated by 12h."
10790462|NCT03610334|FG007|Participant Flow|SAD Placebo 20.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of placebo (microcrystalline cellusose) 20.0 mg is administered to 2 healthy volunteers, in two intakes of 10.0mg, separated by 12h."
11195177|NCT02156466|OG003|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.
10790463|NCT03610334|FG008|Participant Flow|SAD IFB-088 40.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of IFB-088 40.0 mg is administered to 6 healthy volunteers, in two intakes of 20.mg, separated by 12h."
10790464|NCT03610334|FG009|Participant Flow|SAD Placebo 40.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of placebo (microcrystalline cellusose) 40.0 mg is administered to 2 healthy volunteers, in two intakes of 20.0mg, separated by 12h."
10790465|NCT03610334|FG010|Participant Flow|SAD IFB-088 60.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of IFB-088 60.0 mg is administered to 6 healthy volunteers, in two intakes of 30.0mg, separated by 12h."
10790466|NCT03610334|FG011|Participant Flow|SAD Placebo 60.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A single daily dose of placebo (microcrystalline cellusose) 60.0 mg is administered to 2 healthy volunteers, in two intakes of 30.0mg, separated by 12h."
11195178|NCT02156466|OG004|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.
10790467|NCT03610334|FG012|Participant Flow|MAD IFB-088 15.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study.~A single dose of IFB-088 15.0 mg is administered to 6 healthy volunteers, during 14 days"
10790468|NCT03610334|FG013|Participant Flow|MAD Placebo 15.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study.~A single dose of placebo (microcrystalline cellulose) 15.0 mg is administered to 2 healthy volunteers, during 14 days"
10790469|NCT03610334|FG014|Participant Flow|MAD IFB-088 30.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A dose of IFB-088 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days."
10790470|NCT03610334|FG015|Participant Flow|MAD Placebo 30.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A dose of placebo (microcrystalline cellulose) 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days."
10790471|NCT03610334|FG016|Participant Flow|MAD IFB-088 50.0mg|"Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A dose of IFB-088 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days."
10966697|NCT00888433|BG001|Baseline|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
11195179|NCT02156466|EG000|Reported Event|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195180|NCT02156466|EG001|Reported Event|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
10790472|NCT03610334|FG017|Participant Flow|MAD Placebo 50.0mg|"Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.~A dose of placebo (microcrystalline cellulose) 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days."
10790473|NCT03610334|OG000|Outcome|SAD IFB-088 2.5mg|healthy volunteers received IFB-088 2.5mg once daily, in the morning.
10790474|NCT03610334|OG001|Outcome|SAD Placebo 2.5mg|healthy volunteers received placebo 2.5mg once daily, in the morning.
10790475|NCT03610334|OG002|Outcome|SAD IFB-088 5.0mg|healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.
10790476|NCT03610334|OG003|Outcome|SAD Placebo 5.0mg|healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.
10790477|NCT03610334|OG004|Outcome|SAD IFB-088 10.0mg|healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
10790478|NCT03610334|OG005|Outcome|SAD Placebo 10.0mg|healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
10790479|NCT03610334|OG006|Outcome|SAD IFB-088 20.0mg|healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
10790480|NCT03610334|OG007|Outcome|SAD Placebo 20.0mg|healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
10790481|NCT03610334|OG008|Outcome|SAD IFB-088 40.0mg|healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
11195181|NCT02156466|EG002|Reported Event|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
10790482|NCT03610334|OG009|Outcome|SAD Placebo 40.0mg|healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
10790483|NCT03610334|OG010|Outcome|SAD IFB-088 60.0mg|healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
10790484|NCT03610334|OG011|Outcome|SAD Placebo 60.0mg|healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
10790485|NCT03610334|OG012|Outcome|MAD IFB-088 15.0mg|healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
10790486|NCT03610334|OG013|Outcome|MAD Placebo 15.0mg|healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
10790487|NCT03610334|OG014|Outcome|MAD IFB-088 30.0mg|healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
10790488|NCT03610334|OG015|Outcome|MAD Placebo 30.0mg|healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
10790489|NCT03610334|OG016|Outcome|MAD IFB-088 50.0mg|healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
10790490|NCT03610334|OG017|Outcome|MAD Placebo 50.0mg|healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
10790491|NCT03610334|OG012|Outcome|MAD IFB-088 15.0mg|healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.
10790492|NCT03610334|OG013|Outcome|MAD Placebo 15.0mg|healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.
10790493|NCT03610334|OG015|Outcome|MAD Placebo 30.0mg|healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
10790494|NCT03610334|OG017|Outcome|MAD Placebo 50.0mg|healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
10790495|NCT03610334|OG000|Outcome|SAD IFB-088 2.5mg|"Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10790496|NCT03610334|OG001|Outcome|SAD IFB-088 5.0mg|"Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10790497|NCT03610334|OG002|Outcome|SAD IFB-088 10.0mg|"Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10790498|NCT03610334|OG003|Outcome|SAD IFB-088 20.0mg|"Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10790499|NCT03610334|OG004|Outcome|SAD IFB-088 40.0mg|"Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10790500|NCT03610334|OG005|Outcome|SAD IFB-088 60.0mg|"Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm~IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours"
10803890|NCT01190228|OG000|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
10966698|NCT00888433|BG002|Baseline|Total|Total of all reporting groups
10790501|NCT03610334|OG006|Outcome|MAD IFB-088 15.0mg|"Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790502|NCT03610334|OG007|Outcome|MAD IFB-088 30.0mg|"Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790503|NCT03610334|OG008|Outcome|MAD IFB-088 50.0mg|"Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790504|NCT03610334|OG006|Outcome|MAD IFB-088 15 mg|"Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790505|NCT03610334|OG007|Outcome|MAD IFB-088 30 mg|"Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790506|NCT03610334|OG008|Outcome|MAD IFB-088 50 mg|"Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.~IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours."
10790507|NCT03610334|EG000|Reported Event|SAD IFB-088 2.5mg|cohort 1: single daily dose of 2.5mg IFB-088 oral capsule, administered in the morning (8:00am), in one intake
10790508|NCT03610334|EG001|Reported Event|SAD IFB-088 5.0mg|cohort 2: single daily dose of 5.0mg IFB-088 oral capsule, administered in two intakes of 2.5mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
10790509|NCT03610334|EG002|Reported Event|SAD IFB-088 10.0mg|cohort 3: single daily dose of 10.0mg IFB-088 oral capsule, administered in two intakes of 5.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
10790510|NCT03610334|EG003|Reported Event|SAD IFB-088 20.0mg|cohort 4: single daily dose of 20.0mg IFB-088 oral capsule, administered in two intakes of 10.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
10790511|NCT03610334|EG004|Reported Event|SAD IFB-088 40.0mg|cohort 5: single daily dose of 40.0mg IFB-088 oral capsule, administered in two intakes of 20.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
10790512|NCT03610334|EG005|Reported Event|SAD IFB-088 60.0mg|cohort 6: single daily dose of 60.0mg IFB-088 oral capsule, administered in two intakes of 30.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
10790513|NCT03610334|EG006|Reported Event|SAD Placebo|(cohort 1 to 6): single daily dose of placebo oral capsule, administered in two intakes (except for the first SAD dose that is administered in one intake), at 12h intervals, in the morning (8:00am) and in the evening (8:00pm)
10790514|NCT03610334|EG007|Reported Event|MAD IFB-088 15.0mg|cohort 7: subject taking 15.0mg of IFB-088 oral capsule divided in two dose of 7.5mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
10790515|NCT03610334|EG008|Reported Event|MAD IFB-088 30.0mg|cohort 8: subject taking 30.0mg of IFB-088 oral capsule divided in two dose of 15.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
10790516|NCT03610334|EG009|Reported Event|MAD IFB-088 50.0mg|cohort 9: subject taking 50.0mg of IFB-088 oral capsule divided in two dose of 25.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
10790517|NCT03610334|EG010|Reported Event|MAD Placebo|(cohort 7 to 9): subject taking placebo oral capsule divided in two doses, at an interval of 12h, in the morning (8:00am), and in the evning (8:00pm), for 14 days.
10790518|NCT03334539|BG000|Baseline|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10 % ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790519|NCT03334539|BG001|Baseline|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790520|NCT03334539|BG002|Baseline|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790521|NCT03334539|BG003|Baseline|Total|Total of all reporting groups
10790522|NCT03334539|FG000|Participant Flow|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10 % ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57.
10790523|NCT03334539|FG001|Participant Flow|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790524|NCT03334539|FG002|Participant Flow|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10803891|NCT01190228|OG001|Outcome|JE-CV First Dose|JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
10790525|NCT03334539|OG000|Outcome|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10 % ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790526|NCT03334539|OG001|Outcome|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790527|NCT03334539|OG002|Outcome|Placebo|Participants self-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790528|NCT03334539|OG002|Outcome|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790529|NCT03334539|OG000|Outcome|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790530|NCT03334539|OG000|Outcome|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 15, Day 29 and Day 57.
10790531|NCT03334539|OG001|Outcome|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 15, Day 29 and Day 57.
10790532|NCT03334539|OG002|Outcome|Placebo|Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 15, Day 29 and Day 57.
10790533|NCT03334539|EG000|Reported Event|0.10% HL036 Ophthalmic Solution|Participants self-administered HL036 0.10 % ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790534|NCT03334539|EG001|Reported Event|0.25% HL036 Ophthalmic Solution|Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790535|NCT03334539|EG002|Reported Event|Placebo|Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
10790536|NCT03311854|BG000|Baseline|All Enrolled Participants|Baseline data are provided for all participants who were enrolled in the study.
11195182|NCT02156466|EG003|Reported Event|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
10790537|NCT03311854|FG000|Participant Flow|All Treated Population|Of the 16 patients who were screened for the study, 14 were enrolled. All 14 patients completed the study; no patient was withdrawn after the start of treatment. All 14 patients received emapalumab and were included in the all treated population.
10790538|NCT03311854|OG000|Outcome|All Treated Population|The all treated population included all patients who received any part of an infusion of emapalumab.
10790539|NCT03311854|OG000|Outcome|All Treated Population|"The all treated population included all patients who received any part of an infusion of emapalumab.~Note: the Week 4 Visit 2 (post-dose) emapalumab concentration levels were based on 7 participants."
10790540|NCT03311854|OG000|Outcome|All Treated Population: Study Day 0|Levels measured pre-dose on Study Day 0 in participants in the all treated population which included all patients who received any part of an infusion of emapalumab.
10790541|NCT03311854|OG001|Outcome|All Treated Population: 4-week Follow-up Visit/EoS|Levels measured at the 4-week follow-up visit/EoS in participants in the all treated population which included all patients who received any part of an infusion of emapalumab.
10790542|NCT03311854|EG000|Reported Event|All Treated Population|The all treated population included all patients who received any part of an infusion of emapalumab.
10790543|NCT03269344|BG000|Baseline|Control Arm|"Standard supportive care during definitive treatment plus placebo~Placebo Oral Capsule: Placebo"
10790544|NCT03269344|BG001|Baseline|Experimental Arm|"Gabapentin plus standard supportive care~Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures"
10790545|NCT03269344|BG002|Baseline|Total|Total of all reporting groups
10790546|NCT03269344|FG000|Participant Flow|Control Arm|"Standard supportive care during definitive treatment plus placebo~Placebo Oral Capsule: Placebo"
10790547|NCT03269344|FG001|Participant Flow|Experimental Arm|"Gabapentin plus standard supportive care~Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures"
10790548|NCT03269344|OG000|Outcome|Control Arm|"Standard supportive care during definitive treatment plus placebo~Placebo Oral Capsule: Placebo"
10790549|NCT03269344|OG001|Outcome|Experimental Arm|"Gabapentin plus standard supportive care~Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures"
10790550|NCT03269344|EG000|Reported Event|Control Arm|"Standard supportive care during definitive treatment plus placebo~Placebo Oral Capsule: Placebo"
10803892|NCT01190228|OG000|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
11195183|NCT02156466|EG004|Reported Event|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
11195184|NCT02156492|BG000|Baseline|Cohort A|"Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.~Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days."
11195185|NCT02156492|BG001|Baseline|Cohort B|"Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4.~Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22."
10790551|NCT03269344|EG001|Reported Event|Experimental Arm|"Gabapentin plus standard supportive care~Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures"
10790552|NCT03079284|BG000|Baseline|Holding Group|"Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as clinically stable by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure (CPAP). Exclusion criteria were intubation, use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn, presence of seizures on EEG, use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains, and in utero opiate exposure. Written informed consent was obtained from the mother for all patients."
10790553|NCT03079284|FG000|Participant Flow|Holding Group|"Intervention was mothers being able to hold their infants for 30 minutes during therapeutic hypothermia. Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as clinically stable by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure (CPAP). Exclusion criteria were intubation, use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn, presence of seizures on EEG, use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains, and in utero opiate exposure. Written informed consent was obtained from the mother for all patients."
10790554|NCT03079284|OG000|Outcome|Holding Group|"Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as clinically stable by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure (CPAP). Exclusion criteria were intubation, use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn, presence of seizures on EEG, use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains, and in utero opiate exposure. Written informed consent was obtained from the mother for all patients."
10790555|NCT03079284|OG000|Outcome|Holding Group|Holding during cooling: An initial set of vital signs will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold
10790556|NCT03079284|OG000|Outcome|Nursing Participation|Nurses responded to 16 question survey upon completion of holding.
10790557|NCT03079284|EG000|Reported Event|Holding Group|"Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as clinically stable by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure (CPAP). Exclusion criteria were intubation, use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn, presence of seizures on EEG, use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains, and in utero opiate exposure. Written informed consent was obtained from the mother for all patients."
10790558|NCT03076775|BG000|Baseline|Intervention|Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.
10790559|NCT03076775|BG001|Baseline|Usual Care|Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
10790560|NCT03076775|BG002|Baseline|Total|Total of all reporting groups
10790561|NCT03076775|FG000|Participant Flow|Intervention|"Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following Betamethasone (BMZ) administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.~Maternal glycemic control: Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals."
10790562|NCT03076775|FG001|Participant Flow|Usual Care|Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
10790563|NCT03076775|OG000|Outcome|Neonates Born to Mothers Receiving Intervention|Neonates born to mothers who received intervention
10790564|NCT03076775|OG001|Outcome|Neonates Born to Mothers Receiving Usual Care|Neonates born to mothers who received usual care
10790565|NCT03076775|OG000|Outcome|Mothers: Intervention|Mothers will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.
10790566|NCT03076775|OG001|Outcome|Mothers: Usual Care|Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
10790567|NCT03076775|EG000|Reported Event|Mothers: Intervention|Mothers will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.
11195186|NCT02156492|BG002|Baseline|Cohort C|"Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.~Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22."
11195187|NCT02156492|BG003|Baseline|Total|Total of all reporting groups
10790568|NCT03076775|EG001|Reported Event|Mothers: Usual Care|Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
11195188|NCT02156492|FG000|Participant Flow|Cohort A: Evacetrapib Single and Multiple Dose|"Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.~Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days."
10790569|NCT03076775|EG002|Reported Event|Neonates Born to Mothers Receiving Intervention|Neonates born to mothers who received intervention
10790570|NCT03076775|EG003|Reported Event|Neonates Born to Mothers Receiving Usual Care|Neonates born to mothers who received usual care
10790571|NCT02933944|BG000|Baseline|TG02-treatment|"Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).~Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered. Part II was not conducted."
10790572|NCT02933944|FG000|Participant Flow|TG02-treatment|"Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).~Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered. Part II was not conducted."
10790573|NCT02933944|OG000|Outcome|TG02-treatment|"Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).~Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered.~TG02-treatment~Pembrolizumab"
10790574|NCT02933944|OG000|Outcome|TG02-treatment|"Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).~Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered. Part II was not conducted."
10790575|NCT02933944|OG000|Outcome|TG02-treatment|Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).
10790576|NCT02933944|EG000|Reported Event|TG02-treatment|"Part I: The TG02-treatment consists of an intradermal injection of GM-CSF followed by an injection of TG02. The GM-CSF is to be given 15-30 minutes before TG02. TG02-treatment will be administered on Days 1, 8, 15, 22 and 36. If surgery after week 10, TG02-treatment will also be given at week 10 (Day 64).~Part II: TG02-treatment will be given as described under Part I. In addition pembrolizumab will be administered. Part II was not conducted."
11195189|NCT02156492|FG001|Participant Flow|Cohort B: Evacetrapib and Simvastatin|"Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4~Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22."
11195190|NCT02156492|FG002|Participant Flow|Cohort C: Evacetrapib and Atorvastatin|"Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.~Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22."
10790577|NCT02921997|BG000|Baseline|A/H3N2v|One dose of 15 ug of A/H3N2v, at Day 1 A/H3N2v influenza virus vaccine: Monovalent inactivated influenza A/H3N2v virus vaccine (A/Minnesota/11/2010).
10790578|NCT02921997|BG001|Baseline|A/H7N9 + AS03|Two doses of 3.75 ug of A/H7N9 + AS03, at Day 1 and Day 29 (+/- 2 days) AS03: AS03 oil-in-water emulsion adjuvant. A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
10790579|NCT02921997|BG002|Baseline|A/H7N9|Two doses of 3.75 ug of A/H7N9, at Day 1 and Day 29 (+/- 2 days) A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
10790580|NCT02921997|BG003|Baseline|Total|Total of all reporting groups
10790581|NCT02921997|FG000|Participant Flow|A/H3N2v|"One dose of 15 ug of A/H3N2v at Day 1~A/H3N2v influenza virus vaccine: Monovalent inactivated influenza A/H3N2v virus vaccine (A/Minnesota/11/2010)"
10790582|NCT02921997|FG001|Participant Flow|A/H7N9 + AS03|"Two doses of 3.75 ug of A/H7N9 + AS03, at Day 1 and Day 29 (+/- 2 days)~AS03: AS03 oil-in-water emulsion adjuvant.~A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)"
10790583|NCT02921997|FG002|Participant Flow|A/H7N9|"Two doses of 3.75 ug of A/H7N9, at Day 1 and Day 29 (+/- 2 days)~A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)"
10790584|NCT02921997|OG000|Outcome|A/H7N9 + AS03|Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
10790585|NCT02921997|OG001|Outcome|A/H7N9|Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
10790586|NCT02921997|OG000|Outcome|A/H3N2v|One dose of 15 ug monovalent inactivated influenza A/H3N2v virus vaccine at Day 1
10790587|NCT02921997|OG001|Outcome|A/H7N9 + AS03|Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
10790588|NCT02921997|OG002|Outcome|A/H7N9|Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
11195191|NCT02156492|OG000|Outcome|Evacetrapib Single and Multiple Dose|"Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.~Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days."
10790589|NCT02921997|EG000|Reported Event|A/H3N2v|One dose of 15 ug of A/H3N2v virus vaccine at Day 1
11195192|NCT02156492|OG000|Outcome|Evacetrapib Daily and Simvastatin|"Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.~Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22."
10790590|NCT02921997|EG001|Reported Event|A/H7N9 + AS03|Two doses of 3.75 µg of AH7N9 virus vaccine + AS03 adjuvant at Day 1 and Day 29
10790591|NCT02921997|EG002|Reported Event|A/H7N9 + PBS|Two doses of 3.75 µg of A/H7N9 virus vaccine at Day 1 and Day 29
10790592|NCT02833935|BG000|Baseline|Physical Activity Intervention Group|"Participants will complete a baseline questionnaire (week 1) about their demographic information, self-determination theory variables, their current physical activity, and other psychological indicators. They will complete the same questionnaire at two additional time points. First, about halfway through the intervention (week 6), and then at the end (week 10). Participants in the physical activity intervention group will also receive 8 1-hour physical activity sessions over 2 months (1/week) with a trained physical activity counselor through a video-based internet platform.~Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential Remote Education, Augmented Communication, Training and Supervision online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol."
10790593|NCT02833935|BG001|Baseline|Control Group|Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
10790594|NCT02833935|BG002|Baseline|Total|Total of all reporting groups
10790595|NCT02833935|FG000|Participant Flow|Physical Activity Intervention Group|"Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential Remote Education, Augmented Communication, Training and Supervision online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants."
10790596|NCT02833935|FG001|Participant Flow|Control Group|Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
10790597|NCT02833935|OG000|Outcome|Physical Activity Intervention Group|"Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential Remote Education, Augmented Communication, Training and Supervision online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants."
10790598|NCT02833935|OG001|Outcome|Control Group|Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
10790599|NCT02833935|EG000|Reported Event|Physical Activity Intervention Group|"Participants will complete a baseline questionnaire (week 1) about their demographic information, self-determination theory variables, their current physical activity, and other psychological indicators. They will complete the same questionnaire at two additional time points. First, about halfway through the intervention (week 6), and then at the end (week 10). Participants in the physical activity intervention group will also receive 8 1-hour physical activity sessions over 2 months (1/week) with a trained physical activity counselor through a video-based internet platform.~Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential Remote Education, Augmented Communication, Training and Supervision online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol."
10790600|NCT02833935|EG001|Reported Event|Control Group|Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
10790601|NCT02660827|BG000|Baseline|Age 2-13 Yrs|Age 2-13 Yrs Subjects wearing MMT- 670G insulin pump
10790602|NCT02660827|FG000|Participant Flow|Subjects Wearing MMT-670G Insulin Pump|Subjects wearing MMT- 670G insulin pump during Study and Continued Access period
10790603|NCT02660827|OG000|Outcome|Age 2-13 Years Old Wearing MMT-670G Insulin Pump|2-13 years old subjects wearing MMT-670G insulin pump.
10790604|NCT02660827|OG000|Outcome|Age 2-13 Years Old Wearing the MMT-670G Insulin Pump|2-13 years old subjects wearing MMT-670G insulin pump.
10790605|NCT02660827|OG000|Outcome|Age 7-13 Years Old Wearing the MMT-670G Insulin Pump|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.
10790606|NCT02660827|EG000|Reported Event|Age 2-13 Yrs Study Period|2-13 years old subjects wearing MMT-670G insulin pump during Study period.
10790607|NCT02660827|EG001|Reported Event|Age 2-13 Yrs Continued Access Period|2-13 years old subjects wearing MMT-670G insulin pump during Continued Access period.
10790608|NCT02627963|BG000|Baseline|Tivozanib Hydrochloride|"Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.~tivozanib hydrochloride: tivozanib hydrochloride"
10790609|NCT02627963|BG001|Baseline|Sorafenib|"Patients randomized to this arm will receive the comparator drug, sorafenib.~Sorafenib: Sorafenib"
10790610|NCT02627963|BG002|Baseline|Total|Total of all reporting groups
10965749|NCT00883558|EG001|Reported Event|Insulin Lispro Treatment Period|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.
10966699|NCT00888433|FG000|Participant Flow|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
10790611|NCT02627963|FG000|Participant Flow|Tivozanib Hydrochloride|"Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.~tivozanib hydrochloride: tivozanib hydrochloride"
10790612|NCT02627963|FG001|Participant Flow|Sorafenib|"Patients randomized to this arm will receive the comparator drug, sorafenib.~Sorafenib: Sorafenib"
10790613|NCT02627963|OG000|Outcome|Tivozanib Hydrochloride|"Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.~tivozanib hydrochloride: tivozanib hydrochloride"
10790614|NCT02627963|OG001|Outcome|Sorafenib|"Patients randomized to this arm will receive the comparator drug, sorafenib.~Sorafenib: Sorafenib"
10790615|NCT02627963|EG000|Reported Event|Tivozanib Hydrochloride|"Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.~tivozanib hydrochloride: tivozanib hydrochloride"
10790616|NCT02627963|EG001|Reported Event|Sorafenib|"Patients randomized to this arm will receive the comparator drug, sorafenib.~Sorafenib: Sorafenib"
11195193|NCT02156492|OG001|Outcome|Evacetrapib Daily and Atorvastatin|"Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.~Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22."
11195194|NCT02156492|OG001|Outcome|Evactrapib Daily and Atorvastatin|"Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.~Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22."
10790617|NCT02425644|BG000|Baseline|Ponesimod 20 mg|Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
10790618|NCT02425644|BG001|Baseline|Teriflunomide 14 mg|Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
10790619|NCT02425644|BG002|Baseline|Total|Total of all reporting groups
10790620|NCT02425644|FG000|Participant Flow|Ponesimod 20 mg|Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
11195195|NCT02156492|OG000|Outcome|Evacetrapib Daily and Simvastatin|"Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22."
10790621|NCT02425644|FG001|Participant Flow|Teriflunomide 14 mg|Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
10790622|NCT02425644|OG000|Outcome|Ponesimod 20 mg|Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
10790623|NCT02425644|OG001|Outcome|Teriflunomide 14 mg|Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
10790624|NCT02425644|EG000|Reported Event|Ponesimod 20 mg|Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
10790625|NCT02425644|EG001|Reported Event|Teriflunomide 14 mg|Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
10790626|NCT02395614|BG000|Baseline|All Participants|"88 participants were included. In each participant, 1 mastectomy pocket was randomized to TAS and the other to CHG.~CHG consisted of commercially prepared 0.05% CHG solution (IrriSept, 0.05% CHG in sterile water, IrrimaxCorporation, Lawrenceville, GA).~TAS contained 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline."
10790627|NCT02395614|FG000|Participant Flow|Participants Undergoing Bilateral Mastectomy|"This group includes participants undergoing bilateral mastectomy with immediate breast reconstruction and tissue expander.~Each participant will receive an irrigation of chlorhexidine solution 0.05% (IrriSept, 0.05% CHG in sterile water) on one breast and an irrigation of triple antibiotic solution (composed of cefazolin, gentamicin, and bacitracin) on the other breast."
10790628|NCT02395614|OG000|Outcome|Participants Undergoing Bilateral Mastectomy|"This group includes participants undergoing bilateral mastectomy with immediate breast reconstruction and tissue expander.~Each participant will receive an irrigation of chlorhexidine solution 0.05% (IrriSept, 0.05% CHG in sterile water) on one breast and an irrigation of triple antibiotic solution (composed of cefazolin, gentamicin, and bacitracin) on the other breast."
10790629|NCT02395614|EG000|Reported Event|Chlorhexidine Irrigation|"Each patient received triple antibiotic solution on one breast and the CHG on the other breast.~CHG consisted of commercially prepared 0.05% CHG solution (IrriSept, 0.05% CHG in sterile water, Irrimax Corporation, Lawrenceville, GA."
10790630|NCT02395614|EG001|Reported Event|Triple Antibiotic Irrigation|"Each patient received triple antibiotic solution on one breast and the CHG on the other breast.~Triple antibiotic solution contains 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline (NS). If the patient is allergic to either component - the allergen will not be used in the solution - for irrigation."
11195196|NCT02156492|OG001|Outcome|Evacetrapib Daily and Atrovastatin|"Part 2, Cohort C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14~Part 2, Cohort C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22."
11195197|NCT02156492|OG000|Outcome|Evacetrapib Single Dose Day 2|Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.
11195198|NCT02156492|OG001|Outcome|Evacetrapib Multiple Dose Day 22|Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.
11195199|NCT02156492|EG000|Reported Event|Evacetrapib Single Cohort A|Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.
10790631|NCT02340221|BG000|Baseline|Placebo+Fulvestrant|Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790632|NCT02340221|BG001|Baseline|Taselisib+Fulvestrant|Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790633|NCT02340221|BG002|Baseline|Total|Total of all reporting groups
10790634|NCT02340221|FG000|Participant Flow|Placebo+Fulvestrant|Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790635|NCT02340221|FG001|Participant Flow|Taselisib+Fulvestrant|Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790636|NCT02340221|OG000|Outcome|Placebo+Fulvestrant|Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790637|NCT02340221|OG001|Outcome|Taselisib+Fulvestrant|Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790638|NCT02340221|OG000|Outcome|Taselisib+Fulvestrant|Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790639|NCT02340221|EG000|Reported Event|Placebo+Fulvestrant|Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790640|NCT02340221|EG001|Reported Event|Taselisib+Fulvestrant|Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
10790641|NCT02270957|BG000|Baseline|Abatacept|"Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Abatacept"
10790642|NCT02270957|BG001|Baseline|Placebo|Patients receive Placebo. At any time that they meet non-response criteria (primary endpoint) they may elect to be treated with any standard of care medication or open label abatacept Placebo
10790643|NCT02270957|BG002|Baseline|Total|Total of all reporting groups
10790644|NCT02270957|FG000|Participant Flow|Abatacept|"Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Abatacept"
10790645|NCT02270957|FG001|Participant Flow|Placebo|Patients receive Placebo but at the time they meet non-response criteria they may elect open label abatacept or any standard of care to treat their SLE
10790646|NCT02270957|OG000|Outcome|Abatacept|"Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Abatacept"
10790647|NCT02270957|OG001|Outcome|Placebo|"Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.~Placebo"
10790648|NCT02270957|OG001|Outcome|Placebo|"Patients receive Placebo but if the primary endpoint is met as non-response at any time they may elect any standard of care treatment or may initiate abatacept open label.~Placebo"
10790649|NCT02270957|EG000|Reported Event|Abatacept|Patients receive Abatacept 125 mg subcutaneously weekly for six months.
11195200|NCT02156492|EG001|Reported Event|Evacetrapib Multiple|Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.
11195201|NCT02156492|EG002|Reported Event|Simvastatin|Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4.
10790650|NCT02270957|EG001|Reported Event|Placebo|Patients receive Placebo subcutaneously weekly for six months.
10790651|NCT02134925|BG000|Baseline|Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
10790652|NCT02134925|BG001|Baseline|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
10790653|NCT02134925|BG002|Baseline|Total|Total of all reporting groups
10790654|NCT02134925|FG000|Participant Flow|Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
10790655|NCT02134925|FG001|Participant Flow|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
10790656|NCT02134925|OG000|Outcome|Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
10790657|NCT02134925|OG001|Outcome|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
10790658|NCT02134925|EG000|Reported Event|Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)|Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
10790659|NCT02134925|EG001|Reported Event|Arm II (Placebo)|Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
10790660|NCT02054104|BG000|Baseline|Cohort 1/Vaccine Plus Chemotherapy|"H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.~Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
11195202|NCT02156492|EG003|Reported Event|Evacetrapib Single Cohort B|Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14
10790661|NCT02054104|BG001|Baseline|Cohort 2/Vaccine Alone|"H1299 cell lysates with iscomatrix adjuvant vaccine~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790662|NCT02054104|BG002|Baseline|Total|Total of all reporting groups
10790663|NCT02054104|FG000|Participant Flow|Cohort 1/Vaccine Plus Chemotherapy|"H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.~Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790664|NCT02054104|FG001|Participant Flow|Cohort 2/Vaccine Alone|"H1299 cell lysates with iscomatrix adjuvant vaccine~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790665|NCT02054104|OG000|Outcome|Cohort 1/Vaccine Plus Chemotherapy|"H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.~Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790666|NCT02054104|OG001|Outcome|Cohort 2/Vaccine Alone|"H1299 cell lysates with iscomatrix adjuvant vaccine~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10802498|NCT04236635|FG004|Participant Flow|Group 5: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3."
10803893|NCT01190228|OG000|Outcome|JE-CV Booster|Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial
11195203|NCT02156492|EG004|Reported Event|Evacetrapib and Simvastatin|Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.
10790667|NCT02054104|EG000|Reported Event|Cohort 1/Vaccine Plus Chemotherapy|"H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.~Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790668|NCT02054104|EG001|Reported Event|Cohort 2/Vaccine Alone|"H1299 cell lysates with iscomatrix adjuvant vaccine~H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).~Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED)."
10790669|NCT01899144|BG000|Baseline|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
10790670|NCT01899144|FG000|Participant Flow|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
10790671|NCT01899144|OG000|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
10790672|NCT01899144|OG001|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
10790673|NCT01899144|OG002|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
10790674|NCT01899144|OG003|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
10790675|NCT01899144|OG004|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
10790676|NCT01899144|EG000|Reported Event|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
10790677|NCT01899144|EG001|Reported Event|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
10790678|NCT01899144|EG002|Reported Event|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
10790679|NCT01899144|EG003|Reported Event|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
10790680|NCT01899144|EG004|Reported Event|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
10790681|NCT01793610|BG000|Baseline|Comparator-dose MDMA (40 mg) and Psychotherapy|Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
11195204|NCT02156492|EG005|Reported Event|Atorvastatin|Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.
11195205|NCT02156492|EG006|Reported Event|Evacetrapib Single Cohort C|Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14
10790682|NCT01793610|BG001|Baseline|Active Dose 2 MDMA (100 mg) and Psychotherapy|Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
10790683|NCT01793610|BG002|Baseline|Active Dose 1 MDMA (125 mg) and Psychotherapy|Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
10790684|NCT01793610|BG003|Baseline|Total|Total of all reporting groups
10790685|NCT01793610|FG000|Participant Flow|Comparator-dose MDMA (40 mg) and Psychotherapy|Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
10790686|NCT01793610|FG001|Participant Flow|Active Dose 2 MDMA (100 mg) and Psychotherapy|Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
10790687|NCT01793610|FG002|Participant Flow|Active Dose 1 MDMA (125 mg) and Psychotherapy|Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
10790688|NCT01793610|OG000|Outcome|Comparator-dose MDMA (40 mg) and Psychotherapy|Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
10790689|NCT01793610|OG001|Outcome|Active Dose 2 MDMA (100 mg) and Psychotherapy|Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
10790690|NCT01793610|OG002|Outcome|Active Dose 1 MDMA (125 mg) and Psychotherapy|Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
10790691|NCT01793610|OG000|Outcome|Comparator-dose (40 mg) MDMA and Psychotherapy|Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
10790692|NCT01793610|OG001|Outcome|Active Dose 2 (100 mg) MDMA and Psychotherapy|Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
10790693|NCT01793610|OG002|Outcome|Active Dose 1 (125 mg) MDMA and Psychotherapy|Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
10790694|NCT01793610|EG000|Reported Event|Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1)|Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
10790695|NCT01793610|EG001|Reported Event|Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1)|Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
10790696|NCT01793610|EG002|Reported Event|Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1)|Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
10790697|NCT01793610|EG003|Reported Event|Active Dose 1 and Active Dose 2 (100mg or 125mg) and Psychotherapy (Stage 2)|Subjects who receive the comparator dose will be offered the option to continue to the open-label Stage 2. In the first session, active dose 2 will be administered and the therapists will choose one of the two active doses of MDMA for the second and third experimental sessions, with an optional supplemental half dose at each of three experimental sessions at time points equivalent to those in Stage 1.
10802499|NCT04236635|FG005|Participant Flow|Group 6: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1."
10802500|NCT04236635|OG000|Outcome|Group 1: CCH Single Injection Technique|"Participants were administered 0.07 mg CCH subcutaneously using a single injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
10802501|NCT04236635|OG001|Outcome|Group 2: CCH Single Injection Technique|Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.
10802502|NCT04236635|OG002|Outcome|Group 3: CCH Single Injection Technique|Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
10802503|NCT04236635|OG003|Outcome|Group 4: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
10802504|NCT04236635|OG004|Outcome|Group 5: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3."
10802505|NCT04236635|OG005|Outcome|Group 6: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1."
10802506|NCT04236635|OG000|Outcome|CCH Subcutaneous Injection|Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique.
10802507|NCT04236635|EG000|Reported Event|Group 1: CCH Single Injection Technique|"Participants were administered 0.07 mg CCH subcutaneously using a single injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
11382961|NCT02692651|OG001|Outcome|Vancomycin|Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
10802508|NCT04236635|EG001|Reported Event|Group 2: CCH Single Injection Technique|Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.
10802509|NCT04236635|EG002|Reported Event|Group 3: CCH Single Injection Technique|Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
10802510|NCT04236635|EG003|Reported Event|Group 4: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked (Area 1 and Area 2) areas of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14."
10790698|NCT01757665|BG000|Baseline|Edwards Pericardial Aortic Bioprosthesis, Model 11000A|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790699|NCT01757665|BG001|Baseline|Edwards Pericardial Mitral Bioprosthesis, Model 11000M|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790700|NCT01757665|BG002|Baseline|Total|Total of all reporting groups
10790701|NCT01757665|FG000|Participant Flow|Edwards Pericardial Aortic Bioprosthesis, Model 11000A|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790702|NCT01757665|FG001|Participant Flow|Edwards Pericardial Mitral Bioprosthesis, Model 11000M|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790703|NCT01757665|OG000|Outcome|Edwards Pericardial Bioprosthesis, Models 11000A & 11000M|"The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.~The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve."
10790704|NCT01757665|OG000|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790705|NCT01757665|OG001|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790706|NCT01757665|OG000|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790707|NCT01757665|OG001|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
11195206|NCT02156492|EG007|Reported Event|Evacetrapib and Atorvastatin|Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.
10790708|NCT01757665|OG002|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790709|NCT01757665|OG003|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790710|NCT01757665|OG004|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
11195207|NCT02156674|BG000|Baseline|Naglazyme®|"weekly Naglazyme® infusion for 2 years~Naglazyme®: 1 mg per kg of body weight administered once weekly as an intravenous infusion"
10790711|NCT01757665|OG005|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790712|NCT01757665|OG006|Outcome|Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790713|NCT01757665|OG000|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790714|NCT01757665|OG001|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790715|NCT01757665|OG002|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790716|NCT01757665|OG003|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790717|NCT01757665|OG004|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790718|NCT01757665|OG005|Outcome|Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790719|NCT01757665|OG000|Outcome|Edwards Pericardial Bioprosthesis, Model 11000A|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790720|NCT01757665|EG000|Reported Event|Edwards Pericardial Aortic Bioprosthesis, Model 11000A|The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.
10790721|NCT01757665|EG001|Reported Event|Edwards Pericardial Mitral Bioprosthesis, Model 11000M|The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
10790722|NCT01482195|BG000|Baseline|Recombinant Adeno-Associated Virus|Recombinant Adeno-Associated Virus: Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus
11195208|NCT02156674|FG000|Participant Flow|Naglazyme®|"weekly Naglazyme® infusion for 2 years~Naglazyme®: 1 mg per kg of body weight administered once weekly as an intravenous infusion"
11195209|NCT02156674|OG000|Outcome|Naglazyme®|"weekly Naglazyme® infusion for 2 years~Naglazyme®: 1 mg per kg of body weight administered once weekly as an intravenous infusion"
11195210|NCT02156674|EG000|Reported Event|Naglazyme®|"weekly Naglazyme® infusion for 2 years~Naglazyme®: 1 mg per kg of body weight administered once weekly as an intravenous infusion"
10790723|NCT01482195|FG000|Participant Flow|Recombinant Adeno-Associated Virus|Recombinant Adeno-Associated Virus: Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus
10790724|NCT01482195|OG000|Outcome|Recombinant Adeno-Associated Virus Injected Eyes|Eyes with RP which received a single dose of subretinal recombinant Adeno-Associated Virus injection.
10790725|NCT01482195|OG001|Outcome|Fellow Eyes|Eyes with RP which did not receive subretinal recombinant Adeno-Associated Virus injection.
10790726|NCT01482195|EG000|Reported Event|Recombinant Adeno-Associated Virus|Recombinant Adeno-Associated Virus: Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus
10790727|NCT01468831|BG000|Baseline|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Pill with inactive ingredients in a pink opaque capsule"
10790728|NCT01468831|BG001|Baseline|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg of minocycline in a pink opaque capsule"
10790729|NCT01468831|BG002|Baseline|Total|Total of all reporting groups
10790730|NCT01468831|FG000|Participant Flow|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Pill with inactive ingredients in a pink opaque capsule"
10790731|NCT01468831|FG001|Participant Flow|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg of minocycline in a pink opaque capsule"
10790732|NCT01468831|OG000|Outcome|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Pill with inactive ingredients in a pink opaque capsule"
10790733|NCT01468831|OG001|Outcome|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg of minocycline in a pink opaque capsule"
10790734|NCT01468831|EG000|Reported Event|Placebo|"Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months~Placebo: Pill with inactive ingredients in a pink opaque capsule"
10790735|NCT01468831|EG001|Reported Event|Minocycline|"Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months~Minocycline: 100 mg of minocycline in a pink opaque capsule"
10790736|NCT01383109|BG000|Baseline|Pyronaridine|14C-labeled Pyronaridine: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
10790737|NCT01383109|FG000|Participant Flow|Pyronaridine|14C-labeled Pyronaridine: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
10790738|NCT01383109|OG000|Outcome|Pyronaridine|14C-labeled Pyronaridine: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
10790739|NCT01383109|EG000|Reported Event|Pyronaridine|14C-labeled Pyronaridine: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
10790740|NCT00822120|BG000|Baseline|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790741|NCT00822120|BG001|Baseline|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790742|NCT00822120|BG002|Baseline|Total|Total of all reporting groups
10790743|NCT00822120|FG000|Participant Flow|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790744|NCT00822120|FG001|Participant Flow|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790745|NCT00822120|FG002|Participant Flow|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
10790746|NCT00822120|FG003|Participant Flow|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
10790747|NCT00822120|FG004|Participant Flow|HIV-positive and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
10790748|NCT00822120|FG005|Participant Flow|HIV-positive and PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
10790749|NCT00822120|OG000|Outcome|HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap|HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
10790750|NCT00822120|OG000|Outcome|HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP|HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
10803894|NCT01190228|OG002|Outcome|Varicella Vaccine Group|JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
10790751|NCT00822120|OG000|Outcome|HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy|HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
11195211|NCT02156687|BG000|Baseline|Cololast, Inc. Restorell Y Mesh|"Y mesh~Y mesh: Y mesh"
11195212|NCT02156687|BG001|Baseline|Coloplast, Inc. Restorelle Dual Flat Mesh|"Dual flat mesh~Dual flat mesh: Dual flat mesh"
10790752|NCT00822120|OG000|Outcome|PET-negative: Continued ABVD After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
10790753|NCT00822120|OG001|Outcome|PET-positive: BEACOPP Escalated After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
10790754|NCT00822120|OG000|Outcome|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790755|NCT00822120|OG001|Outcome|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
11195213|NCT02156687|BG002|Baseline|Total|Total of all reporting groups
11195214|NCT02156687|FG000|Participant Flow|Coloplast, Inc. Restorelle Y Mesh|Subjects implanted with Coloplast, Inc. Restorelle Y mesh at the time of minimally invasive sacrocolpopexy.
11195215|NCT02156687|FG001|Participant Flow|Coloplast, Inc. Restorelle Dual Flat Mesh|Subjects implanted with Coloplast, Inc. Restorelle Dual flat mesh at the time of minimally invasive sacrocolpopexy.
11195216|NCT02156687|OG000|Outcome|Coloplast, Inc. Restorelle Y Mesh|"Y mesh~Y mesh: Y mesh"
11195217|NCT02156687|OG001|Outcome|Coloplast, Inc. Restorelle Dual Flat Mesh|"Dual flat mesh~Dual flat mesh: Dual flat mesh"
11195218|NCT02156687|EG000|Reported Event|Coloplast, Inc. Restorelle Y Mesh|"Y mesh~Y mesh: Y mesh"
11195219|NCT02156687|EG001|Reported Event|Coloplast, Inc. Restorelle Dual Flat Mesh|"Dual flat mesh~Dual flat mesh: Dual flat mesh"
11195220|NCT02156804|BG000|Baseline|Nivolumab 3mg/kg|Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
11195221|NCT02156804|FG000|Participant Flow|Nivolumab 3mg/kg|Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
11382962|NCT02692651|EG000|Reported Event|Fidaxomicin|Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
10790756|NCT00822120|OG002|Outcome|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
10790757|NCT00822120|OG000|Outcome|HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap|HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
10790758|NCT00822120|OG001|Outcome|PET-positive: BEACOPP Standard After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
10790759|NCT00822120|OG000|Outcome|Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790760|NCT00822120|OG001|Outcome|PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
11195222|NCT02156804|OG000|Outcome|Nivolumab 3mg/kg|Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
11195223|NCT02156804|EG000|Reported Event|NIVOLUMAB 3 MG/KG IV|Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
11195224|NCT02156908|BG000|Baseline|D-serine|"D-serine~D-serine: D-serine 60 mg/kg"
11195225|NCT02156908|BG001|Baseline|No Intervention|
11195226|NCT02156908|BG002|Baseline|Total|Total of all reporting groups
11195227|NCT02156908|FG000|Participant Flow|D-serine|"D-serine~D-serine: D-serine 60 mg/kg (3 sessions, open label)"
11195228|NCT02156908|FG001|Participant Flow|No Intervention|3 sessions without D-serine
11195229|NCT02156908|OG000|Outcome|D-serine|"D-serine~D-serine: D-serine 60 mg/kg"
11195230|NCT02156908|OG001|Outcome|no Intervention|
11195231|NCT02156908|OG001|Outcome|No Intervention|
11195232|NCT02156908|EG000|Reported Event|D-serine|"D-serine~D-serine: D-serine 60 mg/kg"
11195233|NCT02156908|EG001|Reported Event|no Intervention|no intervention
11195234|NCT02157103|BG000|Baseline|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
10790761|NCT00822120|OG002|Outcome|PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
10790762|NCT00822120|EG000|Reported Event|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790763|NCT00822120|EG001|Reported Event|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
10790764|NCT00822120|EG002|Reported Event|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
10790765|NCT00822120|EG003|Reported Event|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
10790766|NCT00822120|EG004|Reported Event|HIV-positive and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
10790767|NCT00822120|EG005|Reported Event|HIV-positive and PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
10790768|NCT00603954|BG000|Baseline|Flu-TBI|"Conditioning regimen consisting of fludarabine 30 mg/m2 on days -4, -3 and -2 (total dose 90 mg/m2), followed by a singe dose of 2 Gy TBI administered on day 0, at a low dose-rate (≈ 7 cGy/min), before infusion of cells.~Conditioning regimen TBI + Fludarabine: 2 Gy TBI, Fludarabine 90 mg/m²"
10790769|NCT00603954|BG001|Baseline|TLI-ATG|"Conditioning consisting of 8 Gy TLI and ATG. TLI will be administered by linear accelerator at a dose of 80 cGy daily, starting 11 days before transplantation, until a total of 10 doses (800 cGy) has been delivered. The irradiation will consist of a supradiaphragmatic mantle field, a subdiaphragmatic field including an inverted Y and splenic ports, encompassing all major lymphoid organs, including the thymus, spleen, and lymph nodes, as used in the treatment of Hodgkin's disease (Kaplan HS, Cancer Research 26:1268-1276, 1966). The Waldeyer ring is not included. ATG (Thymoglobulin®, Genzyme), at a dose of 1.5 mg/kg/d, will be given intravenously on days -11 through -7.~Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin]): TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg"
10790770|NCT00603954|BG002|Baseline|Total|Total of all reporting groups
10790771|NCT00603954|FG000|Participant Flow|Flu-TBI|"Conditioning regimen consisting of fludarabine 30 mg/m2 on days -4, -3 and -2 (total dose 90 mg/m2), followed by a singe dose of 2 Gy TBI administered on day 0, at a low dose-rate (≈ 7 cGy/min), before infusion of cells.~Conditioning regimen TBI + Fludarabine: 2 Gy TBI, Fludarabine 90 mg/m²"
10790772|NCT00603954|FG001|Participant Flow|TLI-ATG|"Conditioning consisting of 8 Gy TLI and ATG. TLI will be administered by linear accelerator at a dose of 80 cGy daily, starting 11 days before transplantation, until a total of 10 doses (800 cGy) has been delivered. The irradiation will consist of a supradiaphragmatic mantle field, a subdiaphragmatic field including an inverted Y and splenic ports, encompassing all major lymphoid organs, including the thymus, spleen, and lymph nodes, as used in the treatment of Hodgkin's disease (Kaplan HS, Cancer Research 26:1268-1276, 1966). The Waldeyer ring is not included. ATG (Thymoglobulin®, Genzyme), at a dose of 1.5 mg/kg/d, will be given intravenously on days -11 through -7.~Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin]): TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg"
11195235|NCT02157103|FG000|Participant Flow|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
11195236|NCT02157103|OG000|Outcome|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
10790773|NCT00603954|OG000|Outcome|Flu-TBI|"Conditioning regimen consisting of fludarabine 30 mg/m2 on days -4, -3 and -2 (total dose 90 mg/m2), followed by a singe dose of 2 Gy TBI administered on day 0, at a low dose-rate (≈ 7 cGy/min), before infusion of cells.~Conditioning regimen TBI + Fludarabine: 2 Gy TBI, Fludarabine 90 mg/m²"
10790774|NCT00603954|OG001|Outcome|TLI-ATG|"Conditioning consisting of 8 Gy TLI and ATG. TLI will be administered by linear accelerator at a dose of 80 cGy daily, starting 11 days before transplantation, until a total of 10 doses (800 cGy) has been delivered. The irradiation will consist of a supradiaphragmatic mantle field, a subdiaphragmatic field including an inverted Y and splenic ports, encompassing all major lymphoid organs, including the thymus, spleen, and lymph nodes, as used in the treatment of Hodgkin's disease (Kaplan HS, Cancer Research 26:1268-1276, 1966). The Waldeyer ring is not included. ATG (Thymoglobulin®, Genzyme), at a dose of 1.5 mg/kg/d, will be given intravenously on days -11 through -7.~Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin]): TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg"
10790775|NCT00603954|OG000|Outcome|TLI-ATG|"Conditioning consisting of 8 Gy TLI and ATG. TLI will be administered by linear accelerator at a dose of 80 cGy daily, starting 11 days before transplantation, until a total of 10 doses (800 cGy) has been delivered. The irradiation will consist of a supradiaphragmatic mantle field, a subdiaphragmatic field including an inverted Y and splenic ports, encompassing all major lymphoid organs, including the thymus, spleen, and lymph nodes, as used in the treatment of Hodgkin's disease (Kaplan HS, Cancer Research 26:1268-1276, 1966). The Waldeyer ring is not included. ATG (Thymoglobulin®, Genzyme), at a dose of 1.5 mg/kg/d, will be given intravenously on days -11 through -7.~Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin]): TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg"
10790776|NCT00603954|EG000|Reported Event|Flu-TBI|"Conditioning regimen consisting of fludarabine 30 mg/m2 on days -4, -3 and -2 (total dose 90 mg/m2), followed by a singe dose of 2 Gy TBI administered on day 0, at a low dose-rate (≈ 7 cGy/min), before infusion of cells.~Conditioning regimen TBI + Fludarabine: 2 Gy TBI, Fludarabine 90 mg/m²"
10803895|NCT01190228|EG000|Reported Event|JE-CV Vaccine Booster|Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
10790777|NCT00603954|EG001|Reported Event|TLI-ATG|"Conditioning consisting of 8 Gy TLI and ATG. TLI will be administered by linear accelerator at a dose of 80 cGy daily, starting 11 days before transplantation, until a total of 10 doses (800 cGy) has been delivered. The irradiation will consist of a supradiaphragmatic mantle field, a subdiaphragmatic field including an inverted Y and splenic ports, encompassing all major lymphoid organs, including the thymus, spleen, and lymph nodes, as used in the treatment of Hodgkin's disease (Kaplan HS, Cancer Research 26:1268-1276, 1966). The Waldeyer ring is not included. ATG (Thymoglobulin®, Genzyme), at a dose of 1.5 mg/kg/d, will be given intravenously on days -11 through -7.~Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin]): TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg"
10802511|NCT04236635|EG004|Reported Event|Group 5: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3."
10802512|NCT04236635|EG005|Reported Event|Group 6: CCH Multiple Injection Technique|"Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.~Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1."
10802513|NCT04156399|BG000|Baseline|Acupuncture|"All subjects will receive active acupuncture.~Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol."
10802514|NCT04156399|FG000|Participant Flow|Acupuncture|"All subjects will receive active acupuncture.~Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol."
10802515|NCT04156399|OG000|Outcome|Acupuncture|"All subjects will receive active acupuncture.~Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol."
10802516|NCT04156399|EG000|Reported Event|Acupuncture|"All subjects will receive active acupuncture.~Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol."
10803896|NCT01190228|EG001|Reported Event|JE-CV Vaccine First Dose|JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
10790778|NCT05087524|BG000|Baseline|BinaxNOW Surveillance|Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
10790779|NCT05087524|FG000|Participant Flow|BinaxNOW Surveillance|"Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting. MMSD has obtained a Clinical Laboratory Improvement Amendments (CLIA) waiver for collection of samples. When there is a positive test, a saliva sample will be collected for testing with a standard polymerase chain reaction (PCR) method. The standard PCR samples will be processed at University of Wisconsin (UW) Clinical Laboratory.~BinaxNOW Ag Card: A nasal swab specimen is collected from the participant, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The participant sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines."
10790780|NCT05087524|OG000|Outcome|BinaxNOW Surveillance|Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
10790781|NCT05087524|EG000|Reported Event|BinaxNOW Surveillance|Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
10790782|NCT04532294|BG000|Baseline|Placebo|Participants received a single intravenous dose of matching placebo
10790783|NCT04532294|BG001|Baseline|BGB-DXP593 10 mg/kg|Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
10790784|NCT04532294|BG002|Baseline|BGB-DXP593 30 mg/kg|Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
10790785|NCT04532294|BG003|Baseline|Total|Total of all reporting groups
10790786|NCT04532294|FG000|Participant Flow|Placebo|Participants received a single intravenous dose of matching placebo
10790787|NCT04532294|FG001|Participant Flow|BGB-DXP593 10 mg/kg|Participants received a single 10 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
10790788|NCT04532294|FG002|Participant Flow|BGB-DXP593 30 mg/kg|Participants received a single 30 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
10790789|NCT04532294|OG000|Outcome|Placebo|Participants received a single intravenous dose of matching placebo
10790790|NCT04532294|OG001|Outcome|BGB-DXP593 10 mg/kg|Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
10790791|NCT04532294|OG002|Outcome|BGB-DXP593 30 mg/kg|Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
10790792|NCT04532294|OG000|Outcome|BGB-DXP593 10 mg/kg|Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
10790793|NCT04532294|OG001|Outcome|BGB-DXP593 30 mg/kg|Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
11195237|NCT02157103|EG000|Reported Event|Bevacizumab|"Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.~Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion."
10790794|NCT04532294|EG000|Reported Event|Placebo|Participants received a single intravenous dose of matching placebo
10790795|NCT04532294|EG001|Reported Event|BGB-DXP593 10 mg/kg|Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
10790796|NCT04532294|EG002|Reported Event|BGB-DXP593 30 mg/kg|Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
10790797|NCT04250077|BG000|Baseline|CRAFT-A|"Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations."
10790798|NCT04250077|BG001|Baseline|CRAFT-C|"Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances."
10790799|NCT04250077|BG002|Baseline|PEER|"Participants assigned to the PEER group will participate in an online peer support forum with other CSOs.~Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully. This individual also will report any adverse or severe adverse events that members mention online."
10790800|NCT04250077|BG003|Baseline|Total|Total of all reporting groups
11195238|NCT02157168|BG000|Baseline|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..
10790801|NCT04250077|FG000|Participant Flow|CRAFT-A|"Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations."
10790802|NCT04250077|FG001|Participant Flow|CRAFT-C|"Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances~Community R"
10790803|NCT04250077|FG002|Participant Flow|PEER|"Participants assigned to the PEER group will participate in an online peer support forum with other CSOs.~Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully. This individual also will report any adverse or severe adverse events that members mention online.~We The Village Peer Community Forum: An online peer support forum with other CSOs.~M"
10790804|NCT04250077|OG000|Outcome|CRAFT-A|"Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT)"
10790805|NCT04250077|OG001|Outcome|CRAFT-C|"Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances.~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT)"
10790806|NCT04250077|OG002|Outcome|PEER|"Participants assigned to the PEER group will participate in an online peer support forum with other CSOs.~Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully. This individual also will report any adverse or severe adverse events that members mention online.~We The Village Peer Community Forum: An online peer support forum with other CSOs."
10802526|NCT04115228|BG000|Baseline|Study Device|"Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.~Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger."
10803897|NCT01190228|EG002|Reported Event|Varicella Vaccine Group|JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
11195239|NCT02157168|BG001|Baseline|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
11382963|NCT02692651|EG001|Reported Event|Vancomycin|Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
10790807|NCT04250077|OG001|Outcome|CRAFT-C|"Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT)"
10790808|NCT04250077|OG000|Outcome|CRAFT-A|"Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT"
10790809|NCT04250077|EG000|Reported Event|CRAFT-A|"Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT)"
10790810|NCT04250077|EG001|Reported Event|CRAFT-C|"Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills.~CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances.~Community Reinforcement And Family Training (CRAFT): Community Reinforcement Approach and Family Training (CRAFT)"
10790811|NCT04250077|EG002|Reported Event|PEER|"Participants assigned to the PEER group will participate in an online peer support forum with other CSOs.~Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully. This individual also will report any adverse or severe adverse events that members mention online.~We The Village Peer Community Forum: An online peer support forum with other CSOs."
10802527|NCT04115228|FG000|Participant Flow|Study Device|"Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.~Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger."
10802528|NCT04115228|OG000|Outcome|Study Device|"Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.~Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger."
10802529|NCT04115228|EG000|Reported Event|Study Device|"Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.~Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger."
10802530|NCT04052620|BG000|Baseline|DDEA 2.32% Gel/Placebo|The participants were instructed to apply approximately 2 g DDEA 2.32% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning and in the late afternoon for 7 days. Similarly, participants were instructed to apply placebo gel at noon and in the late evening for 7 days. The very first dose was applied at the study center.
10802531|NCT04052620|BG001|Baseline|DDEA 1.16% Gel|The participants were instructed to apply approximately 2 g DDEA 1.16% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning, at noon, in the late afternoon, and in the late evening for 7 days. The very first dose was applied at the study center.
10802532|NCT04052620|BG002|Baseline|Total|Total of all reporting groups
10790812|NCT04068142|BG000|Baseline|Clinical Personnel Safety Planning|Patients will complete a traditional written suicide safety plan with clinical personnel.
10790813|NCT04068142|BG001|Baseline|Peer Supporter Safety Planning|"Patients will complete a traditional written suicide safety plan with peer supporters.~Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers"
10790814|NCT04068142|BG002|Baseline|Total|Total of all reporting groups
10790815|NCT04068142|FG000|Participant Flow|Clinical Personnel Safety Planning|Patients will complete a traditional written suicide safety plan with clinical personnel.
10790816|NCT04068142|FG001|Participant Flow|Peer Supporter Safety Planning|"Patients will complete a traditional written suicide safety plan with peer supporters.~Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the emergency department (ED) relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers"
10790817|NCT04068142|OG000|Outcome|Clinical Personnel Safety Planning|Patients will complete a traditional written suicide safety plan with clinical personnel.
10790818|NCT04068142|OG001|Outcome|Peer Supporter Safety Planning|"Patients will complete a traditional written suicide safety plan with peer supporters.~Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers"
10790819|NCT04068142|EG000|Reported Event|Clinical Personnel Safety Planning|Patients will complete a traditional written suicide safety plan with clinical personnel.
10790820|NCT04068142|EG001|Reported Event|Peer Supporter Safety Planning|"Patients will complete a traditional written suicide safety plan with peer supporters.~Peer Supporter Safety Planning: The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers"
10790821|NCT03961009|BG000|Baseline|Kedrion IVIG 10%|Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
10790822|NCT03961009|FG000|Participant Flow|Kedrion IVIG 10%|Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligrams per kilogram (mg/kg) body weight on every 21 or 28 days for period of 48 weeks.
10790823|NCT03961009|OG000|Outcome|Kedrion IVIG 10%|Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
11195240|NCT02157168|BG002|Baseline|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
11195241|NCT02157168|BG003|Baseline|Total|Total of all reporting groups
11195242|NCT02157168|FG000|Participant Flow|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
11195243|NCT02157168|FG001|Participant Flow|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
10790824|NCT03961009|EG000|Reported Event|Kedrion IVIG 10%|Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight on every 21 or 28 days for period of 48 weeks.
10790825|NCT03875495|BG000|Baseline|Patient Recruitment|3 patients recruited into the study but no patients received Temferon. Study terminated due to inability to recruit additional patients in view of the ongoing COVID-19 pandemic
10790826|NCT03875495|FG000|Participant Flow|Temferon|"Autologous CD34+-enriched hematopoietic progenitor cells exposed ex vivo to a specific lentiviral vector encoding for the human IFN-ɑ2 gene.~Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of IFN-ɑ2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny.~Temferon: Genetically modified autologous HSPCs"
10790827|NCT03875495|OG000|Outcome|Untreated Patients|3 Patients were recruited but did not receive Temferon
10790828|NCT03875495|EG000|Reported Event|Untreated Patients|3 patients recruited but did not receive Temferon
10790829|NCT03702439|BG000|Baseline|MRI, PSA and US Group|Men screened by PSA, MRI and US
10790830|NCT03702439|FG000|Participant Flow|MRI, PSA and US Group|Men eligible for screening with a short MRI or PSA or ultrasound
10790831|NCT03702439|OG000|Outcome|Short MRI Arm|Men who had a Short MRI in study
10790832|NCT03702439|OG000|Outcome|Ultrasound Arm|Men who had a ultrasound in study
10790833|NCT03702439|OG000|Outcome|PSA Arm|Men who had a PSA and one other screening test
10790834|NCT03702439|EG000|Reported Event|MRI, PSA and US Group|Men screened by PSA, MRI and US
10790835|NCT03687190|BG000|Baseline|Tai Chi|Subjects accepted Tai Chi exercise once a week in the hospital, and home-based training with a video.
10790836|NCT03687190|BG001|Baseline|Controlled Group|No Tai Chi training. Only regular out-patient clinic visiting.
10790837|NCT03687190|BG002|Baseline|Total|Total of all reporting groups
10790838|NCT03687190|FG000|Participant Flow|Tai Chi|"participants in this group accepted Tai chi exercise and conventional medicine.~Tai chi: participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 9 months conventional medicine: participants without Tai chi training still received routine conventional medicine"
10790839|NCT03687190|FG001|Participant Flow|Controlled Group|participants were not received Tai chi exercise, but only routine conventional medicine conventional medicine: participants without Tai chi training still received routine conventional medicine
10790840|NCT03687190|OG000|Outcome|Tai Chi|Subjects accepted Tai Chi exercise once a week in the hospital, and home-based training with a video. We measured the SARA before and after the nine months.
10790841|NCT03687190|OG001|Outcome|Controlled Group|No Tai Chi training. Only regular out-patient clinic visiting. We measured the SARA before and after the nine months.
10790842|NCT03687190|EG000|Reported Event|Tai Chi|Participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 9 months
10790843|NCT03687190|EG001|Reported Event|Controlled Group|Participants without Tai chi training still received routine conventional medicine
11195244|NCT02157168|FG002|Participant Flow|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
10802533|NCT04052620|FG000|Participant Flow|DDEA 2.32% Gel/Placebo|The participants were instructed to apply approximately 2 g DDEA 2.32% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning and in the late afternoon for 7 days. Similarly, participants were instructed to apply placebo gel at noon and in the late evening for 7 days. The very first dose was applied at the study center.
10802534|NCT04052620|FG001|Participant Flow|DDEA 1.16% Gel|The participants were instructed to apply approximately 2 g DDEA 1.16% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning, at noon, in the late afternoon, and in the late evening for 7 days. The very first dose was applied at the study center.
10802535|NCT04052620|OG000|Outcome|DDEA 2.32% Gel/Placebo|The participants were instructed to apply approximately 2 g DDEA 2.32% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning and in the late afternoon for 7 days. Similarly, participants were instructed to apply placebo gel at noon and in the late evening for 7 days. The very first dose was applied at the study center.
10802536|NCT04052620|OG001|Outcome|DDEA 1.16% Gel|The participants were instructed to apply approximately 2 g DDEA 1.16% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning, at noon, in the late afternoon, and in the late evening for 7 days. The very first dose was applied at the study center.
10802537|NCT04052620|EG000|Reported Event|DDEA 2.32% Gel/Placebo|The participants were instructed to apply approximately 2 g DDEA 2.32% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning and in the late afternoon for 7 days. Similarly, participants were instructed to apply placebo gel at noon and in the late evening for 7 days. The very first dose was applied at the study center.
10802538|NCT04052620|EG001|Reported Event|DDEA 1.16% Gel|The participants were instructed to apply approximately 2 g DDEA 1.16% gel topically with the fingertips to both sides of affected ankle which corresponds to a region of approximately 200 cm^2 for approximately 1 minute in the morning, at noon, in the late afternoon, and in the late evening for 7 days. The very first dose was applied at the study center.
10849945|NCT00299182|EG000|Reported Event|1 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10790844|NCT03583931|BG000|Baseline|Operative VATS Decortication|"Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema~VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision"
10790845|NCT03583931|BG001|Baseline|Non-operative Fibrinolytic Therapy|"Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.~Fibrinolytic Therapy: Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive."
10790846|NCT03583931|BG002|Baseline|Total|Total of all reporting groups
10790847|NCT03583931|FG000|Participant Flow|Operative VATS Decortication|"Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema~VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision"
10790848|NCT03583931|FG001|Participant Flow|Non-operative Fibrinolytic Therapy|"Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.~Fibrinolytic Therapy: Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive."
10790849|NCT03583931|OG000|Outcome|Operative VATS Decortication|"Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema~VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision"
10790850|NCT03583931|OG001|Outcome|Non-operative Fibrinolytic Therapy|"Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.~Fibrinolytic Therapy: Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive."
10790851|NCT03583931|EG000|Reported Event|Operative VATS Decortication|"Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema~VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision"
10790852|NCT03583931|EG001|Reported Event|Non-operative Fibrinolytic Therapy|"Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.~Fibrinolytic Therapy: Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive."
10790853|NCT03505710|BG000|Baseline|Cohort 1: HER2 Overexpressing|"Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790854|NCT03505710|BG001|Baseline|Cohort 1a: HER2 Overexpressing|"Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790855|NCT03505710|BG002|Baseline|Cohort 2: HER2 Mutated|"Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790856|NCT03505710|BG003|Baseline|Total|Total of all reporting groups
10790857|NCT03505710|FG000|Participant Flow|Cohort 1: HER2 Overexpressing|"Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
11195245|NCT02157168|OG000|Outcome|Control Group (CG)|Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
11195246|NCT02157168|OG001|Outcome|Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
10790858|NCT03505710|FG001|Participant Flow|Cohort 1a: HER2 Overexpressing|"Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790859|NCT03505710|FG002|Participant Flow|Cohort 2: HER2 Mutated|"Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790860|NCT03505710|OG000|Outcome|Cohort 1: HER2 Overexpressing|"Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790861|NCT03505710|OG001|Outcome|Cohort 1a: HER2 Overexpressing|"Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790862|NCT03505710|OG002|Outcome|Cohort 2: HER2 Mutated|"Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790863|NCT03505710|EG000|Reported Event|Cohort 1: HER2 Overexpressing|"Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790864|NCT03505710|EG001|Reported Event|Cohort 1a: HER2 Overexpressing|"Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790865|NCT03505710|EG002|Reported Event|Cohort 2: HER2 Mutated|"Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).~Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion."
10790866|NCT03296553|BG000|Baseline|Valganciclovir|Patients in this group received oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antiretroviral therapy) until suppression of HHV-8 viral load.
10790867|NCT03296553|BG001|Baseline|Combined Antiretroviral Treatment|Patients in this group started standard treatment with cART (combined antiretrovrial therapy) according to current HIV Therapy Mexican guidelines.
10790868|NCT03296553|BG002|Baseline|Total|Total of all reporting groups
10790869|NCT03296553|FG000|Participant Flow|Valganciclovir|"Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.~Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.~20 experimental included 2 eliminated~18 patients included finally."
10790870|NCT03296553|FG001|Participant Flow|Antiretroviral Combinations|"Standard treatment with cART according to current HIV Therapy Mexican guidelines.~Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended~20 control patients included~1 eliminated~19 patients included finally"
10790871|NCT03296553|OG000|Outcome|Valganciclovir|"Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.~Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.~20 experimental included 2 eliminated~18 patients included finally."
10790872|NCT03296553|OG001|Outcome|Antiretroviral Combinations|"Standard treatment with cART according to current HIV Therapy Mexican guidelines.~Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended~20 control patients included~1 eliminated~19 patients included finally"
10790873|NCT03296553|EG000|Reported Event|Valganciclovir|"Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.~Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.~20 experimental included 2 eliminated~18 patients included finally."
10790874|NCT03296553|EG001|Reported Event|Antiretroviral Combinations|"Standard treatment with cART according to current HIV Therapy Mexican guidelines.~Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended~20 control patients included~1 eliminated~19 patients included finally"
10790875|NCT03148795|BG000|Baseline|Talazoparib|Participants received talazoparib 1 mg/day orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was 25 months.
10790876|NCT03148795|FG000|Participant Flow|Talazoparib|Participants received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was 25 months.
10790877|NCT03148795|OG000|Outcome|Talazoparib|Participants received talazoparib 1 mg/day orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was 25 months.
10802539|NCT03933449|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 2 years).
10966700|NCT00888433|FG001|Participant Flow|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
11195247|NCT02157168|OG002|Outcome|Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
11195248|NCT02157168|OG000|Outcome|Baseline: Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~IG1 at Baseline: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
10790878|NCT03148795|EG000|Reported Event|Talazoparib|Participants received talazoparib 1 mg/day orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the participant was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was 25 months.
10790879|NCT03049449|BG000|Baseline|Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~Starting dose: 0.3x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790880|NCT03049449|BG001|Baseline|Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
11195249|NCT02157168|OG001|Outcome|6-Month Follow-up: Intervention Group (IG1)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~IG1 at 6-Month Follow-up: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
11195250|NCT02157168|OG002|Outcome|6-Month Follow-up: Control Group (CG)&Intervention Group (IG2)|"Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker.~CG and IG2 at 6-Month Follow-up: Those not invited constituted the usual care control group (CG). The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
11195251|NCT02157168|EG000|Reported Event|Control Group (CG)|Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited will constitute the usual care control group.
10790881|NCT03049449|BG002|Baseline|Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m^2 and 3 participants received 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3."
10790882|NCT03049449|BG003|Baseline|Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~9.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790883|NCT03049449|BG004|Baseline|Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10802540|NCT03933449|BG001|Baseline|Chemotherapy|Participants received Investigator's choice of chemotherapy for up to approximately 2 years: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle.
10802541|NCT03933449|BG002|Baseline|Total|Total of all reporting groups
11195252|NCT02157168|EG001|Reported Event|Intervention Group (IG1)|"Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group will be made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it."
11195253|NCT02157168|EG002|Reported Event|Intervention Group (IG2)|"Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.~The intervention group will be made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate."
11195254|NCT02157298|BG000|Baseline|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
10790884|NCT03049449|BG005|Baseline|Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.~3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790885|NCT03049449|BG006|Baseline|Cohort 1 No Level Assigned - Enrolled But Not Treated|Participants in this group were enrolled but not treated.
10790886|NCT03049449|BG007|Baseline|Cohort 2 No Level Assigned - Enrolled But Not Treated|Participants in this group were enrolled but not treated.
10790887|NCT03049449|BG008|Baseline|Total|Total of all reporting groups
10790888|NCT03049449|FG000|Participant Flow|Dose Escalation Cohort 1 Dose Level -1 - 0.15x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"0.15x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~No participants were enrolled on dose level -1."
10790889|NCT03049449|FG001|Participant Flow|Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~Starting dose: 0.3x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3"
10790890|NCT03049449|FG002|Participant Flow|Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790891|NCT03049449|FG003|Participant Flow|Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m^2 and 3 participants received 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3."
11195255|NCT02157298|BG001|Baseline|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
10790892|NCT03049449|FG004|Participant Flow|Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~9.0 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790893|NCT03049449|FG005|Participant Flow|Dose Escalation Cohort 1 Dose Level 5 - 18x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"18x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight with a maximum dose of 216x10^7 CAR T cells.~No participants were enrolled on dose level 5."
10790894|NCT03049449|FG006|Participant Flow|Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790895|NCT03049449|FG007|Participant Flow|Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.~3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790896|NCT03049449|FG008|Participant Flow|Cohort 1 No Level Assigned - Enrolled But Not Treated|Participants in this group were enrolled but not treated.
10790897|NCT03049449|FG009|Participant Flow|Cohort 2 No Level Assigned - Enrolled But Not Treated|Participants in this group were enrolled but not treated.
10790898|NCT03049449|OG000|Outcome|All Participants|All participants in Dose Escalation groups Cohort 1 and Cohort 2.
10790899|NCT03049449|OG000|Outcome|Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~Starting dose: 0.3x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10802542|NCT03933449|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 2 years).
10965750|NCT00883675|BG000|Baseline|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
11195256|NCT02157298|BG002|Baseline|Total|Total of all reporting groups
11195257|NCT02157298|FG000|Participant Flow|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
10790900|NCT03049449|OG001|Outcome|Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790901|NCT03049449|OG002|Outcome|Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m^2 and 3 participants received 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3."
10790902|NCT03049449|OG003|Outcome|Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~9.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790903|NCT03049449|OG004|Outcome|Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~0.3x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~0.3 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790904|NCT03049449|OG005|Outcome|Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
11195258|NCT02157298|FG001|Participant Flow|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
10790905|NCT03049449|OG004|Outcome|Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790906|NCT03049449|OG005|Outcome|Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.~3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790907|NCT03049449|OG004|Outcome|Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790908|NCT03049449|EG000|Reported Event|Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~Starting dose: 0.3x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790909|NCT03049449|EG001|Reported Event|Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10802543|NCT03933449|FG001|Participant Flow|Chemotherapy|Participants received Investigator's choice of chemotherapy for up to approximately 2 years: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle.
10802544|NCT03933449|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 2 years).
11195259|NCT02157298|OG000|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
11195260|NCT02157298|OG001|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
10790910|NCT03049449|EG002|Reported Event|Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m^2 and 3 participants received 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3."
10790911|NCT03049449|EG003|Reported Event|Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~9.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790912|NCT03049449|EG004|Reported Event|Dose Escalation Cohort 2 Dose Level 1 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.~1.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~1.0 x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790913|NCT03049449|EG005|Reported Event|Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg|"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.~3.0x10^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight~3.0x10^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3"
10790914|NCT03000569|BG000|Baseline|Part A: Antiparkinsonian Agent(s) Followed by SAGE-217|Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.
10790915|NCT03000569|BG001|Baseline|Part B: Antiparkinsonian Agent(s) + SAGE-217|Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.
10790916|NCT03000569|BG002|Baseline|Total|Total of all reporting groups
10790917|NCT03000569|FG000|Participant Flow|Part A: Antiparkinsonian Agent(s) Followed by SAGE-217|Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.
10790918|NCT03000569|FG001|Participant Flow|Part B: Antiparkinsonian Agent(s) + SAGE-217|Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.
10790919|NCT03000569|OG000|Outcome|Part A: Antiparkinsonian Agent(s) Day 1 to Day 3|Participants received levodopa as antiparkinsonian agents at the normally prescribed dosing schedule, orally for Days 1 to 3.
10790920|NCT03000569|OG001|Outcome|Part A: SAGE-217 Day 4 to Day 7|Participants received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. If the initial dose was not tolerated, doses could be reduced to 10 or 20 mg per day.
10790921|NCT03000569|OG002|Outcome|Part A: Follow-up|Participants resumed levodopa as antiparkinsonian agents at the normally prescribed dosing schedule for Days 8 to 14.
10790922|NCT03000569|OG000|Outcome|Part A: Antiparkinsonian Agent(s) Followed by SAGE-217|Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.
10790923|NCT03000569|OG000|Outcome|Part A: Antiparkinsonian Agent(s) Followed by SAGE-217|Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14..
10790924|NCT03000569|OG000|Outcome|Part B: Antiparkinsonian Agent(s) + SAGE-217|Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.
10790925|NCT03000569|OG001|Outcome|Part B: Follow-up|Participants received antiparkinsonian agent(s) at normally prescribed dosing schedule for Days 8 to 14.
10790926|NCT03000569|EG000|Reported Event|Part A: Antiparkinsonian Agent(s) Day 1 to Day 3|Participants received levodopa as antiparkinsonian agents at the normally prescribed dosing schedule, orally for Days 1 to 3.
10790927|NCT03000569|EG001|Reported Event|Part A: SAGE-217 Day 4 to Day 7|Participants received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. If the initial dose was not tolerated, doses could be reduced to 10 or 20 mg per day.
10790928|NCT03000569|EG002|Reported Event|Part A: Follow-up|Participants resumed levodopa as antiparkinsonian agents at the normally prescribed dosing schedule for Days 8 to 14.
10790929|NCT03000569|EG003|Reported Event|Part B: SAGE-217 Dose 1 to Dose 7|Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.
10966701|NCT00888433|OG000|Outcome|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
10790930|NCT03000569|EG004|Reported Event|Part B: Follow-up|Participants received antiparkinsonian agent(s) at normally prescribed dosing schedule for Days 8 to 14.
10790931|NCT03000530|BG000|Baseline|Part A: SAGE-217|Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated.
10790932|NCT03000530|BG001|Baseline|Part B: Placebo|Eligible participants received matching placebo capsules once daily for 14 days.
10790933|NCT03000530|BG002|Baseline|Part B: SAGE-217|Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
10790934|NCT03000530|BG003|Baseline|Total|Total of all reporting groups
10790935|NCT03000530|FG000|Participant Flow|Part A: SAGE-217|Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.
10790936|NCT03000530|FG001|Participant Flow|Part B: Placebo|Eligible participants received matching placebo capsules once daily for 14 days.
10790937|NCT03000530|FG002|Participant Flow|Part B: SAGE-217|Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
10790938|NCT03000530|OG000|Outcome|Part A: SAGE-217|Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated.
10790939|NCT03000530|OG000|Outcome|Part B: Placebo|Eligible participants received matching placebo capsules once daily for 14 days.
10790940|NCT03000530|OG001|Outcome|Part B: SAGE-217|Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
10790941|NCT03000530|OG000|Outcome|Part A: SAGE-217|Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.
10790942|NCT03000530|OG000|Outcome|Part B: Placebo|Eligible participants received matching placebo once daily for 14 days.
10790943|NCT03000530|OG001|Outcome|Part B: SAGE-217|Eligible participants received SAGE-217, 30 mg, oral solution, once daily for 14 days.
10790944|NCT03000530|EG000|Reported Event|Part A: SAGE-217|Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated.
10790945|NCT03000530|EG001|Reported Event|Part B: Placebo|Eligible participants received matching placebo capsules once daily for 14 days.
10790946|NCT03000530|EG002|Reported Event|Part B: SAGE-217|Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
10790947|NCT02978781|BG000|Baseline|Part A: SAGE-217 Oral Solution|Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg daily on Days 3 to 7 as an oral solution with food in the morning.
10790948|NCT02978781|BG001|Baseline|Part A: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
10790949|NCT02978781|BG002|Baseline|Part C: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.
10790950|NCT02978781|BG003|Baseline|Total|Total of all reporting groups
10790951|NCT02978781|FG000|Participant Flow|Part A: SAGE-217 Oral Solution|Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.
10790952|NCT02978781|FG001|Participant Flow|Part A: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.
10790953|NCT02978781|FG002|Participant Flow|Part B: Placebo|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response (≥30% reduction in kinetic tremor) on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.
10790954|NCT02978781|FG003|Participant Flow|Part B: SAGE-217 Capsules|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive maximum tolerated SAGE-217 in Part A for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.
10790955|NCT02978781|FG004|Participant Flow|Part C: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).
10790956|NCT02978781|OG000|Outcome|Part A: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.
10790957|NCT02978781|OG000|Outcome|Part B: Placebo|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.
10790958|NCT02978781|OG001|Outcome|Part B: SAGE-217 Capsules|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.
10790959|NCT02978781|OG000|Outcome|Part C: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).
10790960|NCT02978781|OG000|Outcome|Part A: SAGE-217 Oral Solution|Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.
10790961|NCT02978781|OG001|Outcome|Part A: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.
10790962|NCT02978781|OG002|Outcome|Part B: Placebo|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.
10790963|NCT02978781|OG003|Outcome|Part B: SAGE-217 Capsules|Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.
10790964|NCT02978781|OG004|Outcome|Part C: SAGE-217 Capsules|Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).
10790965|NCT02978781|OG000|Outcome|Part A: SAGE-217 Oral Solution|Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.
10790966|NCT02978781|OG001|Outcome|Part A: SAGE-217 Capsules|Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
10790967|NCT02978781|OG004|Outcome|Part C: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.
10790968|NCT02978781|OG002|Outcome|Part B: Placebo|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.
10790969|NCT02978781|OG003|Outcome|Part B: SAGE-217 Capsules|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.
10790970|NCT02978781|OG000|Outcome|Part A: SAGE-217|Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
10790971|NCT02978781|OG001|Outcome|Part B: Placebo|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.
10790972|NCT02978781|OG002|Outcome|Part B: SAGE-217 Capsules|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.
10790973|NCT02978781|OG000|Outcome|Part A: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
10790974|NCT02978781|OG003|Outcome|Part C: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.
10790975|NCT02978781|EG000|Reported Event|Part A: SAGE-217 Oral Solution|Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.
10790976|NCT02978781|EG001|Reported Event|Part A: SAGE-217 Capsules|Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
10790977|NCT02978781|EG002|Reported Event|Part B: Placebo|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.
10790978|NCT02978781|EG003|Reported Event|Part B: SAGE-217 Capsules|Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.
11195261|NCT02157298|EG000|Reported Event|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
10790979|NCT02978781|EG004|Reported Event|Part C: SAGE-217 Capsules|Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.
10790980|NCT02964507|BG000|Baseline|Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)|Participants with aromatose inhibitor (AI) failure received GSK525762 60 milligrams (mg) tablet orally once daily and Fulvestrant (FUL) 500 mg was administered intramuscularly (IM) on days 1, 15, 29, and once monthly thereafter.
10790981|NCT02964507|BG001|Baseline|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)|Participants with Cyclin-Dependent Kinase (CDK4/6)/AI failure within 12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790982|NCT02964507|BG002|Baseline|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)|Participants with CDK4/6/AI failure >=12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790983|NCT02964507|BG003|Baseline|Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease|Participants with CDK4/6/AI failure >=12 months with bone only disease received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790984|NCT02964507|BG004|Baseline|Phase I-GSK525762 80mg + FUL 500 mg (AI Failure)|Participants with AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790985|NCT02964507|BG005|Baseline|Phase I-GSK525762 80 mg + FUL 500 mg (CDK4/6+AI Failure)|Participants with CDK4/6/AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790986|NCT02964507|BG006|Baseline|Phase II-GSK525762+FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10790987|NCT02964507|BG007|Baseline|Phase II-Placebo+FUL|Participants were planned to receive Placebo+FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10790988|NCT02964507|BG008|Baseline|Total|Total of all reporting groups
10790989|NCT02964507|FG000|Participant Flow|Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)|Participants with aromatose inhibitor (AI) failure received GSK525762 60 milligrams (mg) tablet orally once daily and Fulvestrant (FUL) 500 mg was administered intramuscularly (IM) on days 1, 15, 29, and once monthly thereafter.
11195262|NCT02157298|EG001|Reported Event|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
11195263|NCT02157376|BG000|Baseline|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
10790990|NCT02964507|FG001|Participant Flow|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)|Participants with Cyclin-Dependent Kinase (CDK4/6)/AI failure within 12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790991|NCT02964507|FG002|Participant Flow|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)|Participants with CDK4/6/AI failure >=12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790992|NCT02964507|FG003|Participant Flow|Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease|Participants with CDK4/6/AI failure >=12 months with bone only disease received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790993|NCT02964507|FG004|Participant Flow|Phase I-GSK525762 80mg + FUL 500 mg (AI Failure)|Participants with AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790994|NCT02964507|FG005|Participant Flow|Phase I-GSK525762 80 mg + FUL 500 mg (CDK4/6+AI Failure)|Participants with CDK4/6/AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790995|NCT02964507|FG006|Participant Flow|Phase II-GSK525762+FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10790996|NCT02964507|FG007|Participant Flow|Phase II-Placebo+FUL|Participants were planned to receive Placebo+FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10790997|NCT02964507|OG000|Outcome|Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)|Participants with aromatose inhibitor (AI) failure received GSK525762 60 milligrams (mg) tablet orally once daily and Fulvestrant (FUL) 500 mg was administered intramuscularly (IM) on days 1, 15, 29, and once monthly thereafter.
10790998|NCT02964507|OG001|Outcome|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)|Participants with Cyclin-Dependent Kinase (CDK4/6)/AI failure within 12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10790999|NCT02964507|OG002|Outcome|Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)|Participants with CDK4/6/AI failure >=12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791000|NCT02964507|OG003|Outcome|Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease|Participants with CDK4/6/AI failure >=12 months with bone only disease received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791001|NCT02964507|OG004|Outcome|Phase I-GSK525762 80mg + FUL 500 mg (AI Failure)|Participants with AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791002|NCT02964507|OG005|Outcome|Phase I-GSK525762 80 mg + FUL 500 mg (CDK4/6+AI Failure)|Participants with CDK4/6/AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791003|NCT02964507|OG000|Outcome|Phase II-GSK525762+FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10791004|NCT02964507|OG001|Outcome|Phase II-Placebo+FUL|Participants were planned to receive Placebo+FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10791005|NCT02964507|OG000|Outcome|Phase II-GSK525762 +FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10791006|NCT02964507|EG000|Reported Event|Phase I- GSK525762 60mg+FUL 500mg (AI Failure)|Participants with aromatose inhibitor (AI) failure received GSK525762 60 milligrams (mg) tablet orally once daily and Fulvestrant (FUL) 500 mg was administered intramuscularly (IM) on days 1, 15, 29, and once monthly thereafter.
10791007|NCT02964507|EG001|Reported Event|Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure < 12M)|Participants with Cyclin-Dependent Kinase (CDK4/6)/AI failure within 12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791008|NCT02964507|EG002|Reported Event|Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M)|Participants with CDK4/6/AI failure >=12 months received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791009|NCT02964507|EG003|Reported Event|Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M Bone Only Disease|Participants with CDK4/6/AI failure >=12 months with bone only disease received GSK525762 60 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791010|NCT02964507|EG004|Reported Event|Phase I-GSK525762 80mg+FUL 500mg (AI Failure)|Participants with AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791011|NCT02964507|EG005|Reported Event|Phase I-GSK525762 80mg+FUL 500mg (CDK4/6+AI Failure)|Participants with CDK4/6/AI failure received GSK525762 80 mg tablet orally once daily and FUL 500 mg was administered IM on days 1, 15, 29, and once monthly thereafter.
10791012|NCT02964507|EG006|Reported Event|Phase II-GSK525762 +FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10791013|NCT02964507|EG007|Reported Event|Phase II-Placebo+FUL|Participants were planned to receive GSK525762+ FUL. The dose was to be decided based on the totality of the data at the end of Phase I.
10791014|NCT02942277|BG000|Baseline|Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
10791015|NCT02942277|BG001|Baseline|Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
10791016|NCT02942277|BG002|Baseline|Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
10791017|NCT02942277|BG003|Baseline|Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
10791018|NCT02942277|BG004|Baseline|Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days|Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
10791019|NCT02942277|BG005|Baseline|Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days|Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
10791020|NCT02942277|BG006|Baseline|Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
10791021|NCT02942277|BG007|Baseline|Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
10791022|NCT02942277|BG008|Baseline|Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
10791023|NCT02942277|BG009|Baseline|Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days|Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
10791024|NCT02942277|BG010|Baseline|Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days|Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
10791025|NCT02942277|BG011|Baseline|Total|Total of all reporting groups
11195264|NCT02157376|BG001|Baseline|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
10791026|NCT02942277|FG000|Participant Flow|Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791027|NCT02942277|FG001|Participant Flow|Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791028|NCT02942277|FG002|Participant Flow|Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791029|NCT02942277|FG003|Participant Flow|Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10965751|NCT00883675|FG000|Participant Flow|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
11195265|NCT02157376|BG002|Baseline|Total|Total of all reporting groups
11195266|NCT02157376|FG000|Participant Flow|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
11195267|NCT02157376|FG001|Participant Flow|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
11195268|NCT02157376|OG000|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
11195269|NCT02157376|OG001|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
10791030|NCT02942277|FG004|Participant Flow|Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791031|NCT02942277|FG005|Participant Flow|Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791032|NCT02942277|FG006|Participant Flow|Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and was provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791033|NCT02942277|FG007|Participant Flow|Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10802545|NCT03933449|OG001|Outcome|Chemotherapy|Participants received Investigator's choice of chemotherapy for up to approximately 2 years: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle.
10802546|NCT03933449|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 2 years).
11195270|NCT02157376|EG000|Reported Event|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
11195271|NCT02157376|EG001|Reported Event|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
11195272|NCT02157506|BG000|Baseline|Placebo|Subjects received matching placebo intravenous (IV) infusion.
11195273|NCT02157506|BG001|Baseline|CXL-1427 3μg/kg/Min|Subjects received CXL-1427 3 microgram per kilogram per minute (μg/kg/min) IV infusion as 90 milliliter (mL) of dosing solution at a rate of 15 milliliter per hour (mL/hour) for six hours.
11195274|NCT02157506|BG002|Baseline|CXL-1427 5μg/kg/Min|Subjects received CXL-1427 5 μg/kg/min IV infusion as 90 mL of dosing solution at a rate of 15 mL/hour for six hours.
11195275|NCT02157506|BG003|Baseline|CXL-1427 7μg/kg/Min|Subjects received CXL-1427 7 μg/kg/min IV infusion as 150 mL of dosing solution at a rate of 25 mL/hour for six hours.
11195276|NCT02157506|BG004|Baseline|CXL-1427 12μg/kg/Min|Subjects received CXL-1427 12 μg/kg/min IV infusion as 180 mL of dosing solution at a rate of 30 mL/hour for six hours.
11195277|NCT02157506|BG005|Baseline|Total|Total of all reporting groups
11195278|NCT02157506|FG000|Participant Flow|Placebo|Subjects received matching placebo intravenous (IV) infusion.
10791034|NCT02942277|FG008|Participant Flow|Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791035|NCT02942277|FG009|Participant Flow|Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791036|NCT02942277|FG010|Participant Flow|Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.~Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age~Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791037|NCT02942277|OG000|Outcome|Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791038|NCT02942277|OG001|Outcome|Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10965752|NCT00883675|OG000|Outcome|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
11195279|NCT02157506|FG001|Participant Flow|CXL-1427 3μg/kg/Min|Subjects received CXL-1427 3 microgram per kilogram per minute (μg/kg/min) IV infusion as 90 milliliter (mL) of dosing solution at a rate of 15 milliliter per hour (mL/hour) for six hours.
11195280|NCT02157506|FG002|Participant Flow|CXL-1427 5μg/kg/Min|Subjects received CXL-1427 5 μg/kg/min IV infusion as 90 mL of dosing solution at a rate of 15 mL/hour for six hours.
11195281|NCT02157506|FG003|Participant Flow|CXL-1427 7μg/kg/Min|Subjects received CXL-1427 7 μg/kg/min IV infusion as 150 mL of dosing solution at a rate of 25 mL/hour for six hours.
11195282|NCT02157506|FG004|Participant Flow|CXL-1427 12μg/kg/Min|Subjects received CXL-1427 12 μg/kg/min IV infusion as 180 mL of dosing solution at a rate of 30 mL/hour for six hours.
11195283|NCT02157506|OG000|Outcome|Placebo|Subjects received matching placebo intravenous (IV) infusion.
11195284|NCT02157506|OG001|Outcome|CXL-1427 3μg/kg/Min|Subjects received CXL-1427 3 microgram per kilogram per minute (μg/kg/min) IV infusion as 90 milliliter (mL) of dosing solution at a rate of 15 milliliter per hour (mL/hour) for six hours.
10791039|NCT02942277|OG002|Outcome|Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791040|NCT02942277|OG003|Outcome|Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791041|NCT02942277|OG004|Outcome|Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791042|NCT02942277|OG005|Outcome|Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791043|NCT02942277|OG006|Outcome|Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.~AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791044|NCT02942277|OG007|Outcome|Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791045|NCT02942277|OG008|Outcome|Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791046|NCT02942277|OG009|Outcome|Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791047|NCT02942277|OG010|Outcome|Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.~Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age~Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791048|NCT02942277|OG000|Outcome|Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791049|NCT02942277|OG001|Outcome|Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10802547|NCT03933449|EG001|Reported Event|Chemotherapy|Participants received Investigator's choice of chemotherapy for up to approximately 2 years: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle.
11195285|NCT02157506|OG002|Outcome|CXL-1427 5μg/kg/Min|Subjects received CXL-1427 5 μg/kg/min IV infusion as 90 mL of dosing solution at a rate of 15 mL/hour for six hours.
11195286|NCT02157506|OG003|Outcome|CXL-1427 7μg/kg/Min|Subjects received CXL-1427 7 μg/kg/min IV infusion as 150 mL of dosing solution at a rate of 25 mL/hour for six hours.
11195287|NCT02157506|OG004|Outcome|CXL-1427 12μg/kg/Min|Subjects received CXL-1427 12 μg/kg/min IV infusion as 180 mL of dosing solution at a rate of 30 mL/hour for six hours.
11195288|NCT02157506|EG000|Reported Event|Placebo|Subjects received matching placebo intravenous (IV) infusion.
10791050|NCT02942277|OG002|Outcome|Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.~Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age~Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791051|NCT02942277|EG000|Reported Event|Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791052|NCT02942277|EG001|Reported Event|Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.~The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791053|NCT02942277|EG002|Reported Event|Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791054|NCT02942277|EG003|Reported Event|Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791055|NCT02942277|EG004|Reported Event|Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10965753|NCT00883675|EG000|Reported Event|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
11338920|NCT03620162|OG001|Outcome|Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
10791056|NCT02942277|EG005|Reported Event|Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791057|NCT02942277|EG006|Reported Event|Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.~Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791058|NCT02942277|EG007|Reported Event|Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168~Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.~AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL."
10791059|NCT02942277|EG008|Reported Event|Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali."
10791060|NCT02942277|EG009|Reported Event|Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days|"Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.~Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10802548|NCT03826667|BG000|Baseline|Polyetheretherketone (PEEK) Shoulder Suture Anchors|"Participants who have received PEEK Suture Anchors in the shoulder which included:~HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device"
11195289|NCT02157506|EG001|Reported Event|CXL-1427 3 μg/kg/Min|Subjects received CXL-1427 3 microgram per kilogram per minute (μg/kg/min) IV infusion as 90 milliliter (mL) of dosing solution at a rate of 15 milliliter per hour (mL/hour) for six hours.
11195290|NCT02157506|EG002|Reported Event|CXL-1427 5 μg/kg/Min|Subjects received CXL-1427 5 μg/kg/min IV infusion as 90 mL of dosing solution at a rate of 15 mL/hour for six hours.
10791061|NCT02942277|EG010|Reported Event|Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days|"Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.~Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.~Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age~Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing"
10791062|NCT02942017|BG000|Baseline|Placebo|Participants received an infusion rate equivalent to the 90 μg/kg/h group.
10791063|NCT02942017|BG001|Baseline|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791064|NCT02942017|BG002|Baseline|Total|Total of all reporting groups
10791065|NCT02942017|FG000|Participant Flow|Placebo|Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.
10791066|NCT02942017|FG001|Participant Flow|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791067|NCT02942017|OG000|Outcome|Placebo|Participants received an infusion rate equivalent to the 90 μg/kg/h group.
10791068|NCT02942017|OG001|Outcome|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791069|NCT02942017|EG000|Reported Event|Placebo|Participants received an infusion rate equivalent to the 90 μg/kg/h group.
10791070|NCT02942017|EG001|Reported Event|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791071|NCT02942004|BG000|Baseline|Placebo|Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
10791072|NCT02942004|BG001|Baseline|SAGE-547 60 μg/kg/h|Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
10791073|NCT02942004|BG002|Baseline|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791074|NCT02942004|BG003|Baseline|Total|Total of all reporting groups
10791075|NCT02942004|FG000|Participant Flow|Placebo|Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.
10791076|NCT02942004|FG001|Participant Flow|SAGE-547 60 μg/kg/h|Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
10791077|NCT02942004|FG002|Participant Flow|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791078|NCT02942004|OG000|Outcome|Placebo|Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
10791079|NCT02942004|OG001|Outcome|SAGE-547 60 μg/kg/h|Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
10791080|NCT02942004|OG002|Outcome|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791081|NCT02942004|EG000|Reported Event|Placebo|Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
10791082|NCT02942004|EG001|Reported Event|SAGE-547 60 μg/kg/h|Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
10791083|NCT02942004|EG002|Reported Event|SAGE-547 90 μg/kg/h|Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
10791084|NCT02861014|BG000|Baseline|Ocrelizumab|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10791085|NCT02861014|FG000|Participant Flow|Ocrelizumab|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10791086|NCT02861014|OG000|Outcome|Ocrelizumab|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10791087|NCT02861014|OG001|Outcome|Ocrelizumab Safety Follow-up|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10791088|NCT02861014|EG000|Reported Event|Ocrelizumab|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10791089|NCT02861014|EG001|Reported Event|Ocrelizumab Safety Follow-up|Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
10802549|NCT03826667|FG000|Participant Flow|Polyetheretherketone (PEEK) Shoulder Suture Anchors|"Participants who have received PEEK Suture Anchors in the shoulder which included:~HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device"
10802550|NCT03826667|OG000|Outcome|Polyetheretherketone (PEEK) Shoulder Suture Anchors|"Participants who have received PEEK Suture Anchors in the shoulder which included:~HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device"
10802551|NCT03826667|EG000|Reported Event|HEALICOIL™ PK Preloaded Suture Anchors|"Participants who have received PEEK Suture Anchor:~HEALICOIL™ PK Preloaded Suture Anchors"
10802552|NCT03826667|EG001|Reported Event|BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors|"Participants who have received PEEK Suture Anchor:~BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors"
10802553|NCT03826667|EG002|Reported Event|MULTIFIX™ S Ultra Knotless Fixation System|"Participants who have received PEEK Suture Anchor:~MULTIFIX™ S Ultra Knotless Fixation System"
10802554|NCT03826667|EG003|Reported Event|FOOTPRINT™ Ultra PK Suture Anchors|"Participants who have received PEEK Suture Anchor:~FOOTPRINT™ Ultra PK Suture Anchors"
10802555|NCT03826667|EG004|Reported Event|TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles|"Participants who have received PEEK Suture Anchor:~TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles"
10802556|NCT03826667|EG005|Reported Event|SPEEDSCREW™ Knotless Fixation System|"Participants who have received PEEK Suture Anchor:~SPEEDSCREW™ Knotless Fixation System"
10802557|NCT03826667|EG006|Reported Event|SpeedLock Knotless Fixation Device|"Participants who have received PEEK Suture Anchor:~SpeedLock Knotless Fixation Device"
10802558|NCT03600909|BG000|Baseline|Good Risk Patients|Patients 18 years old or younger with marrow aplasia or single lineage cytopenias (Arm A) will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.6-0.8 mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802559|NCT03600909|BG001|Baseline|Intermediate Risk Patients|Patients 18 years old or younger with MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8-1.0mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802560|NCT03600909|BG002|Baseline|High Risk Patients|Patients 19 years old or older with marrow aplasia or MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.4mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802561|NCT03600909|BG003|Baseline|Total|Total of all reporting groups
10802562|NCT03600909|FG000|Participant Flow|Good Risk Patients|Patients 18 years old or younger with marrow aplasia or single lineage cytopenias (Arm A) will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.6-0.8 mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802563|NCT03600909|FG001|Participant Flow|Intermediate Risk Patients|Patients 18 years old or younger with MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8-1.0mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802564|NCT03600909|FG002|Participant Flow|High Risk Patients|Patients 19 years old or older with marrow aplasia or MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.4mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802565|NCT03600909|OG000|Outcome|Good Risk Patients|Patients 18 years old or younger with marrow aplasia or single lineage cytopenias (Arm A) will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.6-0.8 mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802566|NCT03600909|OG001|Outcome|Intermediate Risk Patients|Patients 18 years old or younger with MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8-1.0mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802567|NCT03600909|OG002|Outcome|High Risk Patients|Patients 19 years old or older with marrow aplasia or MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.4mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802568|NCT03600909|EG000|Reported Event|Good Risk Patients|Patients 18 years old or younger with marrow aplasia or single lineage cytopenias (Arm A) will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.6-0.8 mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
10802569|NCT03600909|EG001|Reported Event|Intermediate Risk Patients|Patients 18 years old or younger with MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8-1.0mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
11195291|NCT02157506|EG003|Reported Event|CXL-1427 7 μg/kg/Min|Subjects received CXL-1427 7 μg/kg/min IV infusion as 150 mL of dosing solution at a rate of 25 mL/hour for six hours.
11195292|NCT02157506|EG004|Reported Event|CXL-1427 12 μg/kg/Min|Subjects received CXL-1427 12 μg/kg/min IV infusion as 180 mL of dosing solution at a rate of 30 mL/hour for six hours.
10791090|NCT02775435|BG000|Baseline|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791091|NCT02775435|BG001|Baseline|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791092|NCT02775435|BG002|Baseline|Total|Total of all reporting groups
10791093|NCT02775435|FG000|Participant Flow|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791094|NCT02775435|FG001|Participant Flow|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791095|NCT02775435|OG000|Outcome|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791096|NCT02775435|OG001|Outcome|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791097|NCT02775435|EG000|Reported Event|Pembrolizumab+Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791098|NCT02775435|EG001|Reported Event|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10791099|NCT02767531|BG000|Baseline|Baseline Features of Patients Enrolled|"120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months.~The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence was then repeated for an additional 6 months"
10791100|NCT02767531|FG000|Participant Flow|Orlistat Then Off Therapy|Randomized to Orlistat for first 3 months, then cross over to no therapy for 3 months, followed by repeat sequence of Orlistat for additional 3 months, and no therapy for next 3 months
10791101|NCT02767531|FG001|Participant Flow|Off Orlistat Then Orlistat|Randomized to no therapy for first 3 months and then cross over to Orlistat for 3 months and then repeat sequence of no therapy for additional 3 months and then Orlistat for next 3 months
10791102|NCT02767531|OG000|Outcome|Orlistat and Then Off Therapy|"Randomized to Orlistat for first 3 months, then cross over to no therapy for 3 months, followed by repeat sequence of Orlistat for additional 3 months, and no therapy for next 3 months~120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months."
10791103|NCT02767531|OG001|Outcome|Off Therapy and Then Orlistat|Randomized to no therapy for first 3 months and then cross over to Orlistat for 3 months and then repeat sequence of no therapy for additional 3 months and then Orlistat for next 3 months
10791104|NCT02767531|EG000|Reported Event|Orlistat|"Each of the two patients, were randomized to receive Orlistat for 3 months in two periods.~Patient 1 took Orlistat 60 mg with the first and second meal and 120 mg with the third meal, whereas Patient 2 took 60 mg of Orlistat 3 times daily with meals."
10791105|NCT02767531|EG001|Reported Event|Off Therapy|"Each of the two patients, were randomized to Off therapy for 3 months in two periods."
10791106|NCT02726880|BG000|Baseline|Referral for Care|Referral for care: Referral for mental health issues and family support services
10791107|NCT02726880|BG001|Baseline|Behavioral Therapy|Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
10791108|NCT02726880|BG002|Baseline|Total|Total of all reporting groups
10791109|NCT02726880|FG000|Participant Flow|Referral for Care|Referral for care: Referral for mental health issues and family support services
10791110|NCT02726880|FG001|Participant Flow|Behavioral Therapy|Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
10791111|NCT02726880|OG000|Outcome|Behavioral Therapy|6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors
10791112|NCT02726880|OG000|Outcome|Referral for Care|Referral for care: Referral for mental health issues and family support services
10791113|NCT02726880|OG001|Outcome|Behavioral Therapy|Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
11382964|NCT02674061|BG000|Baseline|Cohort A: Pembrolizumab|Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
11382965|NCT02674061|BG001|Baseline|Cohort B: Pembrolizumab|Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
11382966|NCT02674061|BG002|Baseline|Total|Total of all reporting groups
11382967|NCT02674061|FG000|Participant Flow|Cohort A: Pembrolizumab|Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
11382968|NCT02674061|FG001|Participant Flow|Cohort B: Pembrolizumab|Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
11382969|NCT02674061|OG000|Outcome|Cohort A: Pembrolizumab|Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
11382970|NCT02674061|OG001|Outcome|Cohort B: Pembrolizumab|Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year)
11382971|NCT02674061|EG000|Reported Event|Cohort A: Pembrolizumab|Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
11382972|NCT02674061|EG001|Reported Event|Cohort B: Pembrolizumab|Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to ~1 additional year).
11382973|NCT02674061|EG002|Reported Event|Cohort A: Second Course Pembrolizumab|Eligible participants in Cohort A who stopped pembrolizumab with stable disease (SD) or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
11382974|NCT02674061|EG003|Reported Event|Cohort B: Second Course Pembrolizumab|Eligible participants in Cohort B who stopped pembrolizumab with SD or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
11382975|NCT02656706|BG000|Baseline|Adjuvant Treatment|Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
11382976|NCT02656706|FG000|Participant Flow|Adjuvant Treatment|Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
11382977|NCT02656706|OG000|Outcome|Adjuvant Treatment|Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
11382978|NCT02656706|EG000|Reported Event|Adjuvant Treatment|Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
11382979|NCT02654314|BG000|Baseline|Melatonin|"5 mg Melatonin nightly, beginning within 24 hours of admission~Melatonin"
11382980|NCT02654314|BG001|Baseline|Cellulose Microcrystylline|"Blue capsule matching the melatonin arm~Melatonin"
11382981|NCT02654314|BG002|Baseline|Total|Total of all reporting groups
11382982|NCT02654314|FG000|Participant Flow|Melatonin|"5 mg Melatonin nightly, beginning within 24 hours of admission~Melatonin"
11382983|NCT02654314|FG001|Participant Flow|Cellulose Microcrystylline|"Blue capsule matching the melatonin arm~Melatonin"
11382984|NCT02654314|OG000|Outcome|Melatonin|"5 mg Melatonin nightly, beginning within 24 hours of admission~Melatonin"
11382985|NCT02654314|OG001|Outcome|Cellulose Microcrystylline|"Blue capsule matching the melatonin arm~Melatonin"
11382986|NCT02654314|EG000|Reported Event|Melatonin|"5 mg Melatonin nightly, beginning within 24 hours of admission~Melatonin"
10791114|NCT02726880|EG000|Reported Event|Referral for Care|Referral for care: Referral for mental health issues and family support services
10791115|NCT02726880|EG001|Reported Event|Behavioral Therapy|Behavioral therapy: 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
10791116|NCT02614547|BG000|Baseline|Placebo|Participants received infusion rates of placebo matched to SAGE-547.
10791117|NCT02614547|BG001|Baseline|SAGE-547|Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
10791118|NCT02614547|BG002|Baseline|Total|Total of all reporting groups
10791119|NCT02614547|FG000|Participant Flow|Placebo|Participants received infusion rates of placebo matched to SAGE-547.
10791120|NCT02614547|FG001|Participant Flow|SAGE-547|Participants received a 4-hour dose titration period of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
10791121|NCT02614547|OG000|Outcome|Placebo|Participants received infusion rates of placebo matched to SAGE-547.
10791122|NCT02614547|OG001|Outcome|SAGE-547|Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
10791123|NCT02614547|OG001|Outcome|SAGE-547|Participants received a 4-hour dose titration period of 30 (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
10791124|NCT02614547|OG000|Outcome|Placebo|Participants received infusion rates of matching placebo identical to SAGE-547.
10791125|NCT02614547|OG001|Outcome|SAGE-547|Participants received a 4-hour dose titration period of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
10791126|NCT02614547|EG000|Reported Event|Placebo|Participants received infusion rates of placebo matched to SAGE-547.
10791127|NCT02614547|EG001|Reported Event|SAGE-547|Participants received a 4-hour dose titration period of 30 microgram per kilogram per hour (microgram/kg/hr) (0 to 4 hours), then 60 microgram/kg/hr (4 to 24 hours), then 90 microgram/kg/hr (24 to 52 hours), followed by a taper to 60 microgram/kg/hr (52 to 56 hours), and 30 microgram/kg/hr (56 to 60 hours).
10791128|NCT02592551|BG000|Baseline|MEDI4736|"8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0."
10791129|NCT02592551|BG001|Baseline|MEDI4736 + Tremelimumab|"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.~Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5."
10791130|NCT02592551|BG002|Baseline|Untreated Arm (Control)|"4 patients will not receive MEDI4736 or Tremelimumab.~no other name: Neither MEDI4736 nor Tremelimumab will be used."
10791131|NCT02592551|BG003|Baseline|Total|Total of all reporting groups
10791132|NCT02592551|FG000|Participant Flow|MEDI4736|"8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0."
10791133|NCT02592551|FG001|Participant Flow|MEDI4736 + Tremelimumab|"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.~Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5."
10791134|NCT02592551|FG002|Participant Flow|Untreated Arm (Control)|"4 patients will not receive MEDI4736 or Tremelimumab.~no other name: Neither MEDI4736 nor Tremelimumab will be used."
10791135|NCT02592551|OG000|Outcome|MEDI4736 + Tremelimumab|"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.~Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5."
10791136|NCT02592551|OG000|Outcome|MEDI4736|"8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0."
10791137|NCT02592551|OG001|Outcome|MEDI4736 + Tremelimumab|"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.~MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.~Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5."
10791138|NCT02592551|OG001|Outcome|Untreated Arm (Control)|"4 patients will not receive MEDI4736 or Tremelimumab.~no other name: Neither MEDI4736 nor Tremelimumab will be used."
11382987|NCT02654314|EG001|Reported Event|Cellulose Microcrystylline|"Blue capsule matching the melatonin arm~Melatonin"
10966702|NCT00888433|OG001|Outcome|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
10791139|NCT02592551|EG000|Reported Event|MEDI4736|MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
10791140|NCT02592551|EG001|Reported Event|MEDI4736 + Tremelimumab|"MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.~Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5."
10791141|NCT02592551|EG002|Reported Event|Untreated Arm (Control)|no other name: Neither MEDI4736 nor Tremelimumab will be used.
10791142|NCT02583048|BG000|Baseline|Arm 1: Bedaquiline|"Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791143|NCT02583048|BG001|Baseline|Arm 2: Delamanid|"Participants received 100 mg of delamanid twice a day for 24 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791144|NCT02583048|BG002|Baseline|Arm 3: Bedaquiline and Delamanid|"Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791145|NCT02583048|BG003|Baseline|Total|Total of all reporting groups
10791146|NCT02583048|FG000|Participant Flow|Arm 1: Bedaquiline|"Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791147|NCT02583048|FG001|Participant Flow|Arm 2: Delamanid|"Participants received 100 mg of delamanid twice a day for 24 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791148|NCT02583048|FG002|Participant Flow|Arm 3: Bedaquiline and Delamanid|"Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.~For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791149|NCT02583048|OG000|Outcome|Arm 1: Bedaquiline|"Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791150|NCT02583048|OG001|Outcome|Arm 2: Delamanid|"Participants received 100 mg of delamanid twice a day for 24 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791151|NCT02583048|OG002|Outcome|Arm 3: Bedaquiline and Delamanid|"Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)~Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791152|NCT02583048|OG000|Outcome|Arm 1: Bedaquiline|"Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791153|NCT02583048|OG001|Outcome|Arm 3: Bedaquiline and Delamanid|"Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791154|NCT02583048|OG000|Outcome|Arm 2: Delamanid|Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
10966703|NCT00888433|EG000|Reported Event|1. DENERVATION|Renal Denervation and maintenance of anti-hypertensive medications
11382988|NCT02628444|BG000|Baseline|STAGE-I Group 1: CYD Dengue Vaccine|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
11382989|NCT02628444|BG001|Baseline|STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)|Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3).
11195293|NCT02157519|BG000|Baseline|Mobile Application Intervention|Mobile Application Intervention: Participants assigned to the intervention group received the mobile application intervention for approximately three months after enrollment. The mobile app intervention consisted of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app were transmitted weekly to the participants' oncology clinicians via a HIPAA-compliant, secure email.
11195294|NCT02157519|BG001|Baseline|Standard Oncology Care|Participants in the control group received standard oncology care only, and completed baseline and post-assessments.
11195295|NCT02157519|BG002|Baseline|Total|Total of all reporting groups
11195296|NCT02157519|FG000|Participant Flow|Mobile Application Intervention|Mobile Application Intervention: Participants assigned to the intervention group received the mobile application intervention for approximately three months after enrollment. The mobile app intervention consisted of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app were transmitted weekly to the participants' oncology clinicians via a HIPAA-compliant, secure email.
11195297|NCT02157519|FG001|Participant Flow|Standard Oncology Care|Participants in the control group received standard oncology care only, and completed baseline and post-assessments.
10802570|NCT03600909|EG002|Reported Event|High Risk Patients|Patients 19 years old or older with marrow aplasia or MDS or AML will be will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.4mg/Kg/dose q 12 hours x 4 doses), cyclophosphamide (10 mg/Kg/dose x 4 doses) and fludarabine (35mg/m2/day x 4 doses).
11338921|NCT03620162|OG002|Outcome|Group 3: Prevnar 13™-Prevnar 13™-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338922|NCT03620162|OG003|Outcome|Group 4: Prevnar 13™-V114-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338923|NCT03620162|OG004|Outcome|Group 5: V114-V114-V114-V114|Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338924|NCT03620162|OG000|Outcome|Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338925|NCT03620162|OG005|Outcome|Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)|Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338926|NCT03620162|EG000|Reported Event|Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™|Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338927|NCT03620162|EG001|Reported Event|Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338928|NCT03620162|EG002|Reported Event|Group 3: Prevnar 13™-Prevnar 13™-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338929|NCT03620162|EG003|Reported Event|Group 4: Prevnar 13™-V114-V114-V114|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
11338930|NCT03620162|EG004|Reported Event|Group 5: V114-V114-V114-V114|Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
10791155|NCT02583048|EG000|Reported Event|Arm 1: Bedaquiline|"Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791156|NCT02583048|EG001|Reported Event|Arm 2: Delamanid|Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
10791157|NCT02583048|EG002|Reported Event|Arm 3: Bedaquiline and Delamanid|"Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.~For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study)."
10791158|NCT02546986|BG000|Baseline|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791159|NCT02546986|BG001|Baseline|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791160|NCT02546986|BG002|Baseline|Total|Total of all reporting groups
10791161|NCT02546986|FG000|Participant Flow|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791162|NCT02546986|FG001|Participant Flow|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791163|NCT02546986|OG000|Outcome|CC-486 and Pembrolizumab (CC-486 + PBZ)|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791164|NCT02546986|OG001|Outcome|Placebo and Pembrolizumab (PBO + PBZ)|Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791165|NCT02546986|EG000|Reported Event|CC-486+Pembrolizumab|Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791166|NCT02546986|EG001|Reported Event|Pembrolizumab+Placebo|Participants received placebo tablets orally on days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on day 1 of a 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
10791167|NCT02539160|BG000|Baseline|DM-Non-CKD (All Participants Regardless of Sequence)|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. Non-CKD was defined by a glomerular filtrate rate (GFR) ≥ 60 ml/min/1.73m2.~Non-CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2).~This is a crossover study where participants in each cohort received both treatments but in difference sequences. Therefore, baseline characteristics are presented for the two separate cohorts but combining patients together regardless of treatment sequence."
10791168|NCT02539160|BG001|Baseline|DM-CKD (All Participants Regardless of Sequence)|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. CKD was defined by a glomerular filtrate rate (GFR) < 60 ml/min/1.73m2.~CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2).~This is a crossover study where participants in each cohort received both treatments but in difference sequences. Therefore, baseline characteristics are presented for the two separate cohorts but combining patients together regardless of treatment sequence."
10791169|NCT02539160|BG002|Baseline|Total|Total of all reporting groups
10802571|NCT03368781|BG000|Baseline|AcQMap Imaging and Mapping|"Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.~AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures"
11338931|NCT03620383|BG000|Baseline|Heat|"Distal topical heat application~Topical Heat: Warm heat pack applied topically in participant hand."
10802572|NCT03368781|FG000|Participant Flow|AcQMap Imaging and Mapping|"Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.~AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures"
11338932|NCT03620383|BG001|Baseline|No Heat|Inactive heat pack to blind the investigator.
11338933|NCT03620383|BG002|Baseline|Total|Total of all reporting groups
11338934|NCT03620383|FG000|Participant Flow|Heat|"Distal topical heat application~Topical Heat: Warm heat pack applied topically in participant hand."
11338935|NCT03620383|FG001|Participant Flow|No Heat|Inactive heat pack to blind the investigator.
11338936|NCT03620383|OG000|Outcome|Heat|"Distal topical heat application~Topical Heat: Warm heat pack applied topically in participant hand."
11338937|NCT03620383|OG001|Outcome|No Heat|Inactive heat pack to blind the investigator.
11338938|NCT03620383|EG000|Reported Event|Heat|"Distal topical heat application~Topical Heat: Warm heat pack applied topically in participant hand."
11338939|NCT03620383|EG001|Reported Event|No Heat|Inactive heat pack to blind the investigator.
11338940|NCT03620708|BG000|Baseline|Motivational Interviewing|"35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line~Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment."
11338941|NCT03620708|BG001|Baseline|Nicotine Replacement Therapy Sampling|"Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment."
11338942|NCT03620708|BG002|Baseline|Referral Only|"Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Referral Only: Participants are provided with a written referral for tobacco dependence treatment."
11338943|NCT03620708|BG003|Baseline|Total|Total of all reporting groups
11338944|NCT03620708|FG000|Participant Flow|Motivational Interviewing|"35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line~Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment."
11338945|NCT03620708|FG001|Participant Flow|Nicotine Replacement Therapy Sampling|"Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment."
11338946|NCT03620708|FG002|Participant Flow|Referral Only|"Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Referral Only: Participants are provided with a written referral for tobacco dependence treatment."
11338947|NCT03620708|OG000|Outcome|Motivational Interviewing|"35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line~Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment."
11338948|NCT03620708|OG001|Outcome|Nicotine Replacement Therapy Sampling|"Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment."
11338949|NCT03620708|OG002|Outcome|Referral Only|"Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Referral Only: Participants are provided with a written referral for tobacco dependence treatment."
11338950|NCT03620708|EG000|Reported Event|Motivational Interviewing|"35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line~Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment."
11338951|NCT03620708|EG001|Reported Event|Nicotine Replacement Therapy Sampling|"Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment."
11338952|NCT03620708|EG002|Reported Event|Referral Only|"Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.~Referral Only: Participants are provided with a written referral for tobacco dependence treatment."
11338953|NCT03620890|BG000|Baseline|Detemir|Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
11338954|NCT03620890|BG001|Baseline|Neutral Protamine Hagedorn (NPH)|Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
11338955|NCT03620890|BG002|Baseline|Total|Total of all reporting groups
10791170|NCT02539160|FG000|Participant Flow|DM-Non-CKD Ticagrelor 90 First|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. Non-CKD was defined by a glomerular filtrate rate (GFR) ≥ 60 ml/min/1.73m2.~Non-CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2).No wash out was performed."
10791171|NCT02539160|FG001|Participant Flow|DM-Non-CKD Ticagrelor 60 First|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. CKD was defined by a glomerular filtrate rate (GFR) < 60 ml/min/1.73m2.~CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2). No wash out was performed."
10791172|NCT02539160|FG002|Participant Flow|DM-CKD Ticagrelor 90 First|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. CKD was defined by a glomerular filtrate rate (GFR) < 60 ml/min/1.73m2.~CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2). No wash out was performed."
10791173|NCT02539160|FG003|Participant Flow|DM-CKD Ticagrelor 60 First|"Patients with diabetes mellitus (DM) and coronary artery disease (CAD) were stratified according to chronic kidney disease (CKD) status. CKD was defined by a glomerular filtrate rate (GFR) < 60 ml/min/1.73m2.~CKD patients were randomized 1:1 to a) standard dose ticagrelor (90mg twice daily) for 7-10 days or b) low dose ticagrelor (60mg twice daily) for 7-10 days (phase 1). After 7-10 days of randomized treatment patients were crossed over to the alternative treatment, which was maintained for additional 7-10 days (phase 2). No wash out was performed."
10791174|NCT02539160|OG000|Outcome|CKD - Ticagrelor 90|Patients with chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
10791175|NCT02539160|OG001|Outcome|CKD - Ticagrelor 60|Patients with chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
10791176|NCT02539160|OG002|Outcome|Non-CKD - Ticagrelor 90|Patients without chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
10791177|NCT02539160|OG003|Outcome|Non-CKD - Ticagrelor 60|Patients without chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
10791178|NCT02539160|EG000|Reported Event|CKD - Ticagrelor 90|Patients with chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
10791179|NCT02539160|EG001|Reported Event|CKD - Ticagrelor 60|Patients with chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
10791180|NCT02539160|EG002|Reported Event|Non-CKD - Ticagrelor 90|Patients without chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
10791181|NCT02539160|EG003|Reported Event|Non-CKD - Ticagrelor 60|Patients without chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
10791182|NCT02507973|BG000|Baseline|LOTV Then APRV|"Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow."
10791183|NCT02507973|FG000|Participant Flow|LOTV, Then APRV|"Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow."
10791184|NCT02507973|OG000|Outcome|LOTV|"Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow."
10802573|NCT03368781|OG000|Outcome|AcQMap Imaging and Mapping|"Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.~AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures"
10802574|NCT03368781|OG000|Outcome|AcQMap Arm|Single arm study no randomized control
11195298|NCT02157519|OG000|Outcome|Mobile Application Intervention|Mobile Application Intervention: Participants assigned to the intervention group received the mobile application intervention for approximately three months after enrollment. The mobile app intervention consisted of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app were transmitted weekly to the participants' oncology clinicians via a HIPAA-compliant, secure email.
11195299|NCT02157519|OG001|Outcome|Standard Oncology Care|Participants in the control group received standard oncology care only, and completed baseline and post-assessments.
11195300|NCT02157519|EG000|Reported Event|Mobile Application Intervention|Mobile Application Intervention: Participants assigned to the intervention group received the mobile application intervention for approximately three months after enrollment. The mobile app intervention consisted of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app were transmitted weekly to the participants' oncology clinicians via a HIPAA-compliant, secure email.
11195301|NCT02157519|EG001|Reported Event|Standard Oncology Care|Participants in the control group received standard oncology care only, and completed baseline and post-assessments.
11195302|NCT02157623|BG000|Baseline|Red Light / Blue Light Participants|Subject will be receive red light PDT on one side of the body, and blue light PDT to the contralateral side after Levulan application
11195303|NCT02157623|FG000|Participant Flow|Red Light/Blue Light Participants|Subjects will receive Red Light PDT on one side of the body, and Blue Light PDT to the contralateral side.
11195304|NCT02157623|OG000|Outcome|Red Light Photodynamic Therapy|One side of patient received red light PDT
11195305|NCT02157623|OG001|Outcome|Blue Light Photodynamic Therapy|The other side of the patient received blue light PDT
11195306|NCT02157623|OG000|Outcome|Pain During Red Light|Pain during red light illumination (on a 0-10 visual analog scale)
11195307|NCT02157623|OG001|Outcome|Pain During Blue Light|Pain during blue light illumination (on a 0-10 visual analog scale)
11382990|NCT02628444|BG002|Baseline|STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)|Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3).
11382991|NCT02628444|BG003|Baseline|Total|Total of all reporting groups
11382992|NCT02628444|FG000|Participant Flow|STAGE-I Group 1: CYD Dengue Vaccine|Participants received 3 doses of CYD dengue vaccine 0.5 milliliters (mL) subcutaneously (SC) at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
11382993|NCT02628444|FG001|Participant Flow|STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)|Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3).
11195308|NCT02157623|OG000|Outcome|Red Light Treatment|RATING SCALE: 6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.
11195309|NCT02157623|OG001|Outcome|Blue Light Treatment|1 to 6 satisfaction scale
11195310|NCT02157623|EG000|Reported Event|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
11195311|NCT02157623|EG001|Reported Event|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
11195312|NCT02157779|BG000|Baseline|Cognitive Behavioral Intervention|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management"
10802575|NCT03368781|OG000|Outcome|Subjects Completing the AcQMap Procedure|Subjects completing the AcQMap Procedure
10802576|NCT03368781|OG000|Outcome|Subject Who Completed the AcQMap Procedure Receiving Pulmonary Vein Ablations|Subject who completed the AcQMap procedure receiving pulmonary vein ablations
10966704|NCT00888433|EG001|Reported Event|2. CONTROL|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
11195313|NCT02157779|BG001|Baseline|Supportive Intervention|"12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support~Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies."
11195314|NCT02157779|BG002|Baseline|Total|Total of all reporting groups
11195315|NCT02157779|FG000|Participant Flow|Cognitive Behavioral Intervention|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management"
11195316|NCT02157779|FG001|Participant Flow|Supportive Intervention|"12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support~Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies."
11195317|NCT02157779|OG000|Outcome|Cognitive Behavioral Intervention (CBI)|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management"
11195318|NCT02157779|OG001|Outcome|Supportive Intervention (SI)|"12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support~Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies."
11382994|NCT02628444|FG002|Participant Flow|STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)|Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3).
10791185|NCT02507973|OG001|Outcome|APRV|"Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow."
10791186|NCT02507973|EG000|Reported Event|LOTV|"All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.~Patient's volume statuses and cardiac functions were assessed during the study period~No data was analyzed to report."
10791187|NCT02507973|EG001|Reported Event|APRV|"All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.~Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.~Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.~Patient's volume statuses and cardiac functions were assessed during the study period~No data was analyzed to report."
10791188|NCT02477618|BG000|Baseline|Placebo|Placebo was administered over the course of 6 days, beginning with a 1-hour dose rate equivalent to 300 micrograms per kilogram per hour (μg/kg/h) of the active arm loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment), which included a step-wise taper during the last 24 hours of treatment.
10791189|NCT02477618|BG001|Baseline|SAGE-547|SAGE-547 Injection was administered over the course of 6 days, beginning with a 1-hour 300 μg/kg/h loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment) or 150 μg/kg/h (open-label treatment), both of which included a step-wise taper during the last 24 hours of treatment. Eligible participants, who did not respond to blinded study treatment, were allowed to enter an Open-label Treatment Period of identical duration.
10791190|NCT02477618|BG002|Baseline|Total|Total of all reporting groups
10791191|NCT02477618|FG000|Participant Flow|Placebo|Placebo was administered over the course of 6 days, beginning with a 1-hour dose rate equivalent to 300 micrograms per kilogram per hour (μg/kg/h) of the active arm loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment), which included a step-wise taper during the last 24 hours of treatment.
10791192|NCT02477618|FG001|Participant Flow|SAGE-547|SAGE-547 Injection was administered over the course of 6 days, beginning with a 1-hour 300 μg/kg/h loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment) or 150 μg/kg/h (open-label treatment), both of which included a step-wise taper during the last 24 hours of treatment. Eligible participants, who did not respond to blinded study treatment, were allowed to enter an Open-label Treatment Period of identical duration.
10791193|NCT02477618|OG000|Outcome|Placebo|Placebo was administered over the course of 6 days, beginning with a 1-hour dose rate equivalent to 300 micrograms per kilogram per hour (μg/kg/h) of the active arm loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment), which included a step-wise taper during the last 24 hours of treatment.
10791194|NCT02477618|OG001|Outcome|SAGE-547|SAGE-547 Injection was administered over the course of 6 days, beginning with a 1-hour 300 μg/kg/h loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment) or 150 μg/kg/h (open-label treatment), both of which included a step-wise taper during the last 24 hours of treatment. Eligible participants, who did not respond to blinded study treatment, were allowed to enter an Open-label Treatment Period of identical duration.
10791195|NCT02477618|EG000|Reported Event|Placebo|Placebo was administered over the course of 6 days, beginning with a 1-hour dose rate equivalent to 300 micrograms per kilogram per hour (μg/kg/h) of the active arm loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment), which included a step-wise taper during the last 24 hours of treatment.
11195319|NCT02157779|OG000|Outcome|Cognitive Behavioral Intervention|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management"
10791196|NCT02477618|EG001|Reported Event|SAGE-547|SAGE-547 Injection was administered over the course of 6 days, beginning with a 1-hour 300 μg/kg/h loading dose, followed by a maintenance period achieving a maximum of 90 μg/kg/h (double-blind treatment) or 150 μg/kg/h (open-label treatment), both of which included a step-wise taper during the last 24 hours of treatment. Eligible participants, who did not respond to blinded study treatment, were allowed to enter an Open-label Treatment Period of identical duration.
10802577|NCT03368781|OG000|Outcome|Subjects Completing the AcQMap Procedure and Receiving Ablations for Non-PV Triggers|Subjects completing the AcQMap procedure and receiving ablations for non-PV triggers
10966705|NCT00888459|BG000|Baseline|Active|4 mg nicotine lozenges
11195320|NCT02157779|OG001|Outcome|Supportive Intervention|"12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support~Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies."
11382995|NCT02628444|FG003|Participant Flow|STAGE-II Group 1a: CYD Vaccine + CYD Booster Vaccine (1 Year)|Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
11382996|NCT02628444|FG004|Participant Flow|STAGE-II Group 2a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
11382997|NCT02628444|FG005|Participant Flow|STAGE-II Group 3a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
11382998|NCT02628444|FG006|Participant Flow|STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years)|Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11382999|NCT02628444|FG007|Participant Flow|STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11383000|NCT02628444|FG008|Participant Flow|STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11383001|NCT02628444|OG000|Outcome|STAGE-I Group 1: CYD Dengue Vaccine|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
11383002|NCT02628444|OG001|Outcome|STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)|Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3).
11383003|NCT02628444|OG000|Outcome|Group 1: CYD Dengue Vaccine-28 Days Post-dose 3 in STAGE-I|Participants who received 3 doses of CYD dengue vaccine in STAGE-I, and were seropositive at Baseline were assessed 28 days after third CYD vaccine in STAGE-I.
11383004|NCT02628444|OG001|Outcome|Group 1a: CYD Dengue Vaccine-28 Days Post 12 Month Booster Dose|Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 1 year (or 12 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
11383005|NCT02628444|OG001|Outcome|Group 2a: CYD Dengue Vaccine-28 Days Post 12 Months Booster Dose|Participants from Group 2 (STAGE-I) who were seropositive at Baseline and received a booster dose at 1 year (or 12 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
11383006|NCT02628444|OG001|Outcome|Group 1b: CYD Dengue Vaccine-28 Days Post 24 Month Booster Dose|Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 2 years (or 24 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
11383007|NCT02628444|OG001|Outcome|Group 2b: CYD Dengue Vaccine-28 Days Post 24 Month Booster Dose|Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 2 years (or 24 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
11383008|NCT02628444|OG002|Outcome|STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)|Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3).
11383009|NCT02628444|OG000|Outcome|STAGE-II Group 1a: CYD Vaccine + CYD Booster Vaccine (1 Year)|Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
11383010|NCT02628444|OG001|Outcome|STAGE-II Group 2a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
11383011|NCT02628444|OG002|Outcome|STAGE-II Group 3a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
10965754|NCT00883688|BG000|Baseline|Bevacizumab + Lapatinib|"Bevacizumab 10 mg/kg intravenous over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week study cycle). Lapatinib 700 mg/m^2/dose given orally 2 times each day."
11383012|NCT02628444|OG003|Outcome|STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years)|Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11383013|NCT02628444|OG004|Outcome|STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11383014|NCT02628444|OG005|Outcome|STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
11383015|NCT02628444|EG000|Reported Event|STAGE-I Group 1: CYD Dengue Vaccine|Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
11383016|NCT02628444|EG001|Reported Event|STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)|Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3).
11383017|NCT02628444|EG002|Reported Event|STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)|Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3).
10791197|NCT02424851|BG000|Baseline|Arm A (BBD)|"Bortezomib, Bendamustine and Dexamethasone~Bortezomib: 1.3 mg/m2 subcutaneously* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791198|NCT02424851|BG001|Baseline|Arm B (BTD)|"Thalidomide, Bendamustine and Dexamethasone~Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791199|NCT02424851|BG002|Baseline|Total|Total of all reporting groups
10791200|NCT02424851|FG000|Participant Flow|Arm A (BBD)|"Bortezomib, Bendamustine and Dexamethasone~Bortezomib: 1.3 mg/m2 subcutaneously* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791201|NCT02424851|FG001|Participant Flow|Arm B (BTD)|"Thalidomide, Bendamustine and Dexamethasone~Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791202|NCT02424851|OG000|Outcome|Arm A (BBD)|"Bortezomib, Bendamustine and Dexamethasone~Bortezomib: 1.3 mg/m2 subcutaneously* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791203|NCT02424851|OG001|Outcome|Arm B (BTD)|"Thalidomide, Bendamustine and Dexamethasone~Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791204|NCT02424851|EG000|Reported Event|Arm A (BBD)|"Bortezomib, Bendamustine and Dexamethasone~Bortezomib: 1.3 mg/m2 subcutaneously* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791205|NCT02424851|EG001|Reported Event|Arm B (BTD)|"Thalidomide, Bendamustine and Dexamethasone~Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle"
10791206|NCT02285504|BG000|Baseline|SAGE-547|Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr [4 hrs], 43 mcg/kg/hr [4 hrs] and 64.5 mcg/kg/hr [4 hrs] on Day 1, followed by 13 to 48 hrs [36 hrs] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr [49 - 52 hrs], 43 mcg/kg/hr [53 - 56 hrs] and 21.5 mcg/kg/hr [57 - 60 hrs] on Day 3).
10791207|NCT02285504|FG000|Participant Flow|SAGE-547|Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour [mcg/kg/hr] [4 hrs], 43 mcg/kg/hr [4 hrs] and 64.5 mcg/kg/hr [4 hrs] on Day 1, followed by 13 to 48 hrs [36 hrs] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr [49 - 52 hrs], 43 mcg/kg/hr [53 - 56 hrs] and 21.5 mcg/kg/hr [57 - 60 hrs] on Day 3).
10791208|NCT02285504|OG000|Outcome|SAGE-547|Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr [4 hrs], 43 mcg/kg/hr [4 hrs] and 64.5 mcg/kg/hr [4 hrs] on Day 1, followed by 13 to 48 hrs [36 hrs] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr [49 - 52 hrs], 43 mcg/kg/hr [53 - 56 hrs] and 21.5 mcg/kg/hr [57 - 60 hrs] on Day 3).
10791209|NCT02285504|EG000|Reported Event|SAGE-547|Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms/kg/hr [4 hrs], 43 micrograms/kg/hr [4 hrs] and 64.5 micrograms/kg/hr [4 hrs] on Day 1, followed by 13 to 48 hrs [36 hrs] maintenance infusion of 86 micrograms/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 micrograms/kg/hr [49 - 52 hrs], 43 micrograms/kg/hr [53 - 56 hrs] and 21.5 micrograms/kg/hr [57 - 60 hrs] on Day 3).
10791210|NCT02227394|BG000|Baseline|All Patients|The results of demographic and baseline characteristics are presented for the safety population overall.
10966706|NCT00888459|BG001|Baseline|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
10966707|NCT00888459|BG002|Baseline|Total|Total of all reporting groups
10791211|NCT02227394|FG000|Participant Flow|Z7200 - Symbicort® Turbohaler|"the patients randomized to this sequence were to receive a single dose consisting of 2 inhalations of the test product (Z7200) on the first dosing day (Period 1, Visit 2), then, after a wash out period of at least 3 days but no more of 31 days, a single dose consisting of 2 inhalations of the reference treatment (Symbicort® Turbohaler) on the second dosing day (Period 2, Visit 3).~Patients were also to receive 2 inhalations with matching placebo to the alternate treatment as a dummy inhaler to achieve double-blinding.~Z7200 is contained in single dose capsules (HPMC) and it is administered through a single dose dry powder inhaler (DPI), that is structurally correspondent to Aerolizer/Cyclohaler device.~Strength: Each delivered dose contains budesonide 80 mcg/inhalation and formoterol fumarate dihydrate 2.25 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01) provided.~Z7200: Total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01).~At visit 2 or 3 (cross-over design)~Symbicort® Turbohaler®: Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)"
10791212|NCT02227394|FG001|Participant Flow|Symbicort® Turbohaler - Z7200|"the patients randomized to this sequence were to receive a single dose consisting of 2 inhalations of the reference treatment (Symbicort® Turbohaler) on the first dosing day (Period 1, Visit 2), then, after a washout period of at least 3 days but no more of 31 days, a single dose consisting of 2 inhalations of the test product (Z7200) on the second dosing day (Period 2, Visit 3).~Patients were also to receive 2 inhalations with a matching placebo to the alternate treatment as a dummy inhaler to achieve double-blinding.~Symbicort® Turbohaler® inhalation powder; AstraZeneca UK Limited. Budesonide and formoterol fumarate dihydrate concentration Strength: Each delivered dose contains budesonide 160 mcg/inhalation and formoterol fumarate dihydrate 4.5 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 320 mcg/9 mcg).~Z7200: Total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01).~At visit 2 or 3 (cross-over design)~Symbicort® Turbohaler®: Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)"
10791213|NCT02227394|OG000|Outcome|Z7200|"Z7200 is contained in single dose capsules (HPMC) and it is administered through a single dose - consisting of two inhalations - dry powder inhaler (DPI), that is structurally correspondent to Aerolizer/Cyclohaler device.~Strength: Each delivered dose contains budesonide 80 mcg/inhalation and formoterol fumarate dihydrate 2.25 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01) provided."
10791214|NCT02227394|OG001|Outcome|Symbicort Turbohaler|Symbicort® Turbohaler® inhalation powder; AstraZeneca UK Limited. Budesonide and formoterol fumarate dihydrate concentration Strength: Each delivered dose -- consisting of two inhalations for a total dose budesonide/formoterol is 320 mcg/9 mcg - contains budesonide 160 mcg/inhalation and formoterol fumarate dihydrate 4.5 mcg/inhalation; two inhalations
10791215|NCT02227394|EG000|Reported Event|Z7200|"Z7200 is contained in single dose capsules (HPMC) and it is administered through a single dose - consisting of two inhalations - dry powder inhaler (DPI), that is structurally correspondent to Aerolizer/Cyclohaler device.~Strength: Each delivered dose contains budesonide 80 mcg/inhalation and formoterol fumarate dihydrate 2.25 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01) provided."
10791216|NCT02227394|EG001|Reported Event|Symbicort Turbohaler|Symbicort® Turbohaler® inhalation powder; AstraZeneca UK Limited. Budesonide and formoterol fumarate dihydrate concentration Strength: Each delivered dose -- consisting of two inhalations for a total dose budesonide/formoterol is 320 mcg/9 mcg - contains budesonide 160 mcg/inhalation and formoterol fumarate dihydrate 4.5 mcg/inhalation; two inhalations
10791217|NCT02073968|BG000|Baseline|Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)|"RADIOTHERAPY: Patients undergo PET-adjusted IMRT five days a week for 5 weeks.~CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy.~CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy and when esophagitis and chemotherapy-induced neuropathy are grade 1 or less, ANC > 1500, and platelet count > 100,000, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians.~Carboplatin: Given IV~Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT~Paclitaxel: Given IV~Positron Emission Tomography: Undergo PET-adjusted IMRT"
10791218|NCT02073968|FG000|Participant Flow|Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)|"RADIOTHERAPY: Patients undergo PET-adjusted IMRT five days a week for 5 weeks.~CONCURRENT CHEMOTHERAPY: Patients receive carboplatin paclitaxel weekly for 5 weeks during thoracic radiotherapy.~OPTIONAL CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of radiotherapy, subjects may receive up to 3 cycles of consolidation carboplatin and paclitaxel."
10791219|NCT02073968|OG000|Outcome|Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)|"RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks.~CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy.~CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians.~Carboplatin: Given IV~Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT~Paclitaxel: Given IV~Positron Emission Tomography: Undergo PET-adjusted IMRT"
10791220|NCT02073968|EG000|Reported Event|Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)|"RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks.~CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy.~CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians.~Carboplatin: Given IV~Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT~Paclitaxel: Given IV~Positron Emission Tomography: Undergo PET-adjusted IMRT"
11383018|NCT02628444|EG003|Reported Event|STAGE-II Group 1a: CYD Vaccine + CYD Booster Vaccine (1 Year)|Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
11383019|NCT02628444|EG004|Reported Event|STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years)|Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
11383020|NCT02628444|EG005|Reported Event|STAGE-II Group 2a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
11383021|NCT02628444|EG006|Reported Event|STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
11383022|NCT02628444|EG007|Reported Event|STAGE-II Group 3a: Placebo + CYD + CYD Booster (1 Year)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
11383023|NCT02628444|EG008|Reported Event|STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years)|Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
11383024|NCT02623998|BG000|Baseline|Intervention|"Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy~insulin glargine: Dose is titrated to achieve fasting normoglycemia~sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose~lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11383025|NCT02623998|BG001|Baseline|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11383026|NCT02623998|BG002|Baseline|Total|Total of all reporting groups
11383027|NCT02623998|FG000|Participant Flow|Intervention|"Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy~insulin glargine: Dose is titrated to achieve fasting normoglycemia~sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose~lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11383028|NCT02623998|FG001|Participant Flow|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11383029|NCT02623998|OG000|Outcome|Intervention|"Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy~insulin glargine: Dose is titrated to achieve fasting normoglycemia~sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose~lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11383030|NCT02623998|OG001|Outcome|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11383031|NCT02623998|EG000|Reported Event|Intervention|"Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy~insulin glargine: Dose is titrated to achieve fasting normoglycemia~sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose~lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11383032|NCT02623998|EG001|Reported Event|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11383033|NCT02623725|BG000|Baseline|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
11383034|NCT02623725|BG001|Baseline|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
11383035|NCT02623725|BG002|Baseline|Total|Total of all reporting groups
11383036|NCT02623725|FG000|Participant Flow|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
11383037|NCT02623725|FG001|Participant Flow|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
11383038|NCT02623725|OG000|Outcome|CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).
11383039|NCT02623725|OG001|Outcome|CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
11383040|NCT02623725|OG000|Outcome|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
11383041|NCT02623725|OG001|Outcome|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
10791221|NCT02003924|BG000|Baseline|Enzalutamide 160 mg|Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
10966708|NCT00888459|FG000|Participant Flow|Active|4 mg nicotine lozenges
11338956|NCT03620890|FG000|Participant Flow|Detemir|Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
10966709|NCT00888459|FG001|Participant Flow|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
10966710|NCT00888459|OG000|Outcome|Active|4 mg nicotine lozenges
11338957|NCT03620890|FG001|Participant Flow|Neutral Protamine Hagedorn (NPH)|Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
11338958|NCT03620890|OG000|Outcome|Detemir|Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
11338959|NCT03620890|OG001|Outcome|Neutral Protamine Hagedorn (NPH)|Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
11338960|NCT03620890|EG000|Reported Event|Detemir|Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
11338961|NCT03620890|EG001|Reported Event|Neutral Protamine Hagedorn (NPH)|Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
11338962|NCT03621085|BG000|Baseline|All Participants|All participants
11338963|NCT03621085|FG000|Participant Flow|Ketamine First, Then Placebo|Ketamine visit (20 mg) first, then Placebo visit (saline)
11338964|NCT03621085|FG001|Participant Flow|Placebo First, Then Ketamine|Placebo visit (saline) first, then Ketamine visit (20 mg)
11338965|NCT03621085|OG000|Outcome|Ketamine|"Subjects will receive up to 20 mg Ketamine Hydrochloride while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.~Ketamine Hydrochloride: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously"
11338966|NCT03621085|OG001|Outcome|Placebo|"Subjects will receive placebo while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.~Placebo: Subjects will receive placebo"
11338967|NCT03621085|EG000|Reported Event|Ketamine|Ketamine trials
11338968|NCT03621085|EG001|Reported Event|Placebo|Placebo trials
11338969|NCT03621189|BG000|Baseline|Active-Active|"Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338970|NCT03621189|BG001|Baseline|Sham-Active|"Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338971|NCT03621189|BG002|Baseline|Total|Total of all reporting groups
11338972|NCT03621189|FG000|Participant Flow|Active-Active|"Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338973|NCT03621189|FG001|Participant Flow|Sham-Active|"Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338974|NCT03621189|OG000|Outcome|Active-Active|"Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338975|NCT03621189|OG001|Outcome|Sham-Active|"Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338976|NCT03621189|OG001|Outcome|Sham Control|"Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338977|NCT03621189|EG000|Reported Event|Active-Active|"Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338978|NCT03621189|EG001|Reported Event|Sham-Active|"Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).~*iTBS = intermittent theta burst stimulation"
11338979|NCT03621202|BG000|Baseline|Saranas Early Bird Bleed Monitoring System (EBBMS)|Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
11338980|NCT03621202|FG000|Participant Flow|Saranas Early Bird Bleed Monitoring System (EBBMS)|Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
11338981|NCT03621202|OG000|Outcome|Saranas Early Bird Bleed Monitoring System (EBBMS)|Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
11338982|NCT03621202|EG000|Reported Event|Saranas Early Bird Bleed Monitoring System (EBBMS)|Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
11338983|NCT03621787|BG000|Baseline|Single Arm Study: Implant Insertion|"Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire will assess bruising and infection risk. A final visit will assess bruising and infection risk by a physician.~Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately."
10791222|NCT02003924|BG001|Baseline|Placebo|Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791223|NCT02003924|BG002|Baseline|Total|Total of all reporting groups
10791224|NCT02003924|FG000|Participant Flow|Enzalutamide 160 mg|Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
10791225|NCT02003924|FG001|Participant Flow|Placebo|Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791226|NCT02003924|FG002|Participant Flow|Placebo Participants Crossover to Enzalutamide 160 mg|Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791227|NCT02003924|OG000|Outcome|Enzalutamide 160 mg|Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
11383042|NCT02623725|EG000|Reported Event|CYD Dengue Vaccine Booster Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
10791228|NCT02003924|OG001|Outcome|Placebo|Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791229|NCT02003924|EG000|Reported Event|Enzalutamide 160 mg|Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
10791230|NCT02003924|EG001|Reported Event|Placebo|Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791231|NCT02003924|EG002|Reported Event|Placebo Patients Crossover to Enzalutamide 160 mg|Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
10791232|NCT01971970|BG000|Baseline|Pediatric IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later."
10791233|NCT01971970|BG001|Baseline|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
11195321|NCT02157779|OG000|Outcome|Cognitive Behavioral Intervention|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management."
11383043|NCT02623725|EG001|Reported Event|Placebo Group|Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
11195322|NCT02157779|EG000|Reported Event|Cognitive Behavioral Intervention|"12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies~Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management."
11195323|NCT02157779|EG001|Reported Event|Supportive Intervention|"12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support~Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies."
11195324|NCT02157909|BG000|Baseline|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
11195325|NCT02157909|BG001|Baseline|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
11195326|NCT02157909|BG002|Baseline|Total|Total of all reporting groups
11195327|NCT02157909|FG000|Participant Flow|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
11195328|NCT02157909|FG001|Participant Flow|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
10791234|NCT01971970|BG002|Baseline|Total|Total of all reporting groups
10791235|NCT01971970|FG000|Participant Flow|Pediatric IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later."
10791236|NCT01971970|FG001|Participant Flow|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791237|NCT01971970|OG000|Outcome|Pediatric IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791238|NCT01971970|OG001|Outcome|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791239|NCT01971970|OG000|Outcome|Pediatric IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later."
10791240|NCT01971970|OG001|Outcome|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
11195329|NCT02157909|OG000|Outcome|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
11195330|NCT02157909|OG001|Outcome|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
11195331|NCT02157909|EG000|Reported Event|Pre-treatment|Includes all subjects / eyes prior to the exposure to the investigational or control products
11195332|NCT02157909|EG001|Reported Event|AOA Modified|Includes all subjects / eyes exposed to AOA Modified lenses
11195333|NCT02157909|EG002|Reported Event|AOA Sphere|Includes all subjects / eyes exposed to AOA Sphere lenses
11195334|NCT02157935|BG000|Baseline|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
11195335|NCT02157935|BG001|Baseline|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
11195336|NCT02157935|BG002|Baseline|Total|Total of all reporting groups
11195337|NCT02157935|FG000|Participant Flow|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
11195338|NCT02157935|FG001|Participant Flow|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
11195339|NCT02157935|OG000|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
11195340|NCT02157935|OG001|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
11195341|NCT02157935|EG000|Reported Event|Formoterol 4.5 ug x2 Bid|
11195342|NCT02157935|EG001|Reported Event|Symbicort 160/4.5 ug x2 Bid|
11195343|NCT02157948|BG000|Baseline|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
11195344|NCT02157948|BG001|Baseline|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
11195345|NCT02157948|BG002|Baseline|Total|Total of all reporting groups
11195346|NCT02157948|FG000|Participant Flow|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
10791241|NCT01971970|OG002|Outcome|Overall|Overall combined data for pediatric and adult IBD patients
10791242|NCT01971970|OG001|Outcome|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791243|NCT01971970|EG000|Reported Event|Pediatric IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791244|NCT01971970|EG001|Reported Event|Adult IBD Patients|"Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab~Infliximab: Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.~Adalimumab: ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2"
10791245|NCT01971970|EG002|Reported Event|Overall|Overall combined data for pediatric and adult IBD patients
10791246|NCT01969409|BG000|Baseline|Placebo|"These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.~Placebo: Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable."
10791247|NCT01969409|BG001|Baseline|Rituximab|"Rituximab i.v. given on two occasions, with 14 days between doses.~Rituximab: i.v. rituximab given on two occasions 14 days apart."
10791248|NCT01969409|BG002|Baseline|Total|Total of all reporting groups
10791249|NCT01969409|FG000|Participant Flow|Placebo|"These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.~Placebo: Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable."
10791250|NCT01969409|FG001|Participant Flow|Rituximab|"Rituximab i.v. given on two occasions, with 14 days between doses.~Rituximab: i.v. rituximab given on two occasions 14 days apart."
10791251|NCT01969409|OG000|Outcome|Placebo|"These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.~Placebo: Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable."
10791252|NCT01969409|OG001|Outcome|Rituximab|"Rituximab i.v. given on two occasions, with 14 days between doses.~Rituximab: i.v. rituximab given on two occasions 14 days apart."
10791253|NCT01969409|EG000|Reported Event|Placebo|"These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.~Placebo: Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable."
10791254|NCT01969409|EG001|Reported Event|Rituximab|"Rituximab i.v. given on two occasions, with 14 days between doses.~Rituximab: i.v. rituximab given on two occasions 14 days apart."
10791255|NCT01459497|BG000|Baseline|Radiation Therapy|"Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks~Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks"
10791256|NCT01459497|BG001|Baseline|Conventional Radiation|"Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks~Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks"
10791257|NCT01459497|BG002|Baseline|Total|Total of all reporting groups
11195347|NCT02157948|FG001|Participant Flow|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
11195348|NCT02157948|OG000|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
11195349|NCT02157948|OG001|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
10791258|NCT01459497|FG000|Participant Flow|Radiation Therapy|"Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks~Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks"
10791259|NCT01459497|FG001|Participant Flow|Conventional Radiation|"Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks~Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks"
10791260|NCT01459497|OG000|Outcome|Radiation Therapy|"Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks~Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks"
10791261|NCT01459497|OG001|Outcome|Conventional Radiation|"Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks~Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks"
10791262|NCT01459497|EG000|Reported Event|Radiation Therapy|"Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks~Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks"
10791263|NCT01459497|EG001|Reported Event|Conventional Radiation|"Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks~Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks"
10802578|NCT03368781|EG000|Reported Event|AcQMap Imaging and Mapping|"Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.~AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures"
10802579|NCT03366428|BG000|Baseline|DS-8201a|Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.
11195350|NCT02157948|EG000|Reported Event|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
11195351|NCT02157948|EG001|Reported Event|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
11383044|NCT02608684|BG000|Baseline|Cisplatin+Gemcitabine+Pembrolizumab|"2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).~Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle Standard of care~Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care~Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion~-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental~Pembrolizumab: Pembrolizumab IV solution~Gemcitabine: Gemcitabine IV solution~Cisplatin: Cisplatin IV solution"
11383045|NCT02608684|FG000|Participant Flow|Cisplatin+Gemcitabine+Pembrolizumab|"2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).~Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle Standard of care~Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care~Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion~-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental~Pembrolizumab: Pembrolizumab IV solution~Gemcitabine: Gemcitabine IV solution~Cisplatin: Cisplatin IV solution"
11383046|NCT02608684|OG000|Outcome|Cisplatin+Gemcitabine+Pembrolizumab|"2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).~Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle Standard of care~Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care~Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion~-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental~Pembrolizumab: Pembrolizumab IV solution~Gemcitabine: Gemcitabine IV solution~Cisplatin: Cisplatin IV solution"
11383047|NCT02608684|EG000|Reported Event|Cisplatin+Gemcitabine+Pembrolizumab|"2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).~Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle Standard of care~Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion~-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care~Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion~-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental~Pembrolizumab: Pembrolizumab IV solution~Gemcitabine: Gemcitabine IV solution~Cisplatin: Cisplatin IV solution"
11383048|NCT02603887|BG000|Baseline|Treatment (Pembrolizumab)|Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
11383049|NCT02603887|FG000|Participant Flow|Treatment (Pembrolizumab)|Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
11383050|NCT02603887|OG000|Outcome|Treatment (Pembrolizumab)|Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
11383051|NCT02603887|EG000|Reported Event|Single Arm, Intermediate-high Risk SMM Participants|Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
11383052|NCT02587520|BG000|Baseline|Adolescents: SP0173 Formulation 1|Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
10791264|NCT01307787|BG000|Baseline|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level."
10791265|NCT01307787|BG001|Baseline|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
11383053|NCT02587520|BG001|Baseline|Adolescents: SP0173 Formulation 2|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383054|NCT02587520|BG002|Baseline|Adolescents: SP0173 Formulation 3|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
10791266|NCT01307787|BG002|Baseline|Total|Total of all reporting groups
11383055|NCT02587520|BG003|Baseline|Adolescents: SP0173 Formulation 4|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383056|NCT02587520|BG004|Baseline|Adolescents: Adacel®|Healthy participants aged 10-18 years received Adacel®.
11383057|NCT02587520|BG005|Baseline|Adolescents: Boostrix®|Healthy participants aged 10-18 years received Boostrix®.
11383058|NCT02587520|BG006|Baseline|Adults: SP0173 Formulation 1|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383059|NCT02587520|BG007|Baseline|Adults: SP0173 Formulation 2|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
10791267|NCT01307787|FG000|Participant Flow|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level."
10791268|NCT01307787|FG001|Participant Flow|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
10791269|NCT01307787|OG000|Outcome|Intervention Fit Program|An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
10791270|NCT01307787|OG001|Outcome|Waiting List Control Group|No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
10791271|NCT01307787|OG000|Outcome|Intervention Fit Program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
10791272|NCT01307787|OG001|Outcome|Waiting List Control Group|no intervention. WLC was allowed to follow the program after the study.
10791273|NCT01307787|OG000|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
10791274|NCT01307787|OG001|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
10791275|NCT01307787|OG000|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
10791276|NCT01307787|EG000|Reported Event|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level."
11195352|NCT02158039|BG000|Baseline|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
10791277|NCT01307787|EG001|Reported Event|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
10791278|NCT01250912|BG000|Baseline|MIBG Imaging on Top of Standard of Care VT Ablation|MIBG/SPECT imaging prior to, and 6 months after the ablation. 123I-metaiodobenzylguanidine: FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection.
10791279|NCT01250912|FG000|Participant Flow|Patients Receiving MIBG Imaging|All patients received MIBG imaging before and 6 months after VT ablation
10791280|NCT01250912|OG000|Outcome|MIBG/SPECT|Assessment by MIBG/SPECT
10791281|NCT01250912|OG001|Outcome|Electroanatomic Imaging Assessment|Assessment electroanatomic by a bipolar voltage of <0.5 mV.
10791282|NCT01250912|OG000|Outcome|MIBG Imaging at Baseline|MIBG/SPECT imaging prior to the ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection.
10791283|NCT01250912|OG000|Outcome|MIBG Imaging at 6 Months|MIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection.
10791284|NCT01250912|EG000|Reported Event|MIBG Imaging on Top of Standard of Care VT Ablation|MIBG/SPECT imaging prior to, and 6 months after the ablation. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection.
10791285|NCT01218555|BG000|Baseline|Lenalidomide Combination With Everolimus|"Non-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.~Lenalidomide: Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.~Everolimus: 5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days."
10791286|NCT01218555|FG000|Participant Flow|Dose Level 1 Lenalidomide/Everolimus 10/5 mg|Participants were administered with lenalidomide 10 mg and everolimus 5mg once daily by mouth, every day of each 28-day cycle.
10791287|NCT01218555|FG001|Participant Flow|Dose Level 2 Lenalidomide/Everolimus|Participants were administered 15/5 of lenalidomide/everolimus once daily by mouth, every day of each 28-day cycle.
10791288|NCT01218555|FG002|Participant Flow|Dose Level 3: Lenalidomide/Everolimus|Patients were administered 20/5/mg of lenalidomide/everolimus once daily by mouth, every day of each 28-day cycle.
10791289|NCT01218555|FG003|Participant Flow|Dose Level 4: Lenalidomide/Everolimus 20/5/mg|Participants were administered with lenalidomide 25 mg and everolimus 5mg once daily by mouth, every day of each 28-day cycle.
10791290|NCT01218555|FG004|Participant Flow|Dose Level 5: Lenalidomide/Everolimus (25/10mg)|Participants were administered with lenalidomide 25 mg and everolimus 10mg once daily by mouth, every day of each 28-day cycle.
10791291|NCT01218555|FG005|Participant Flow|RP2D: L (25mg) and E (10mg)|Participants were administered with lenalidomide 25 mg and everolimus 10mg once daily by mouth, every day of each 28-day cycle.
10791292|NCT01218555|OG000|Outcome|Lenalidomide Combination With Everolimus|"Non-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.~Lenalidomide: Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.~Everolimus: 5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days."
10791293|NCT01218555|EG000|Reported Event|Lenalidomide Combination With Everolimus|Adverse Events were collected irrespective of dose administered and it is therefore not possible to report using separate Arms/Groups).
10791294|NCT01141712|BG000|Baseline|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
10791295|NCT01141712|FG000|Participant Flow|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day from Days -5 to -2, Cytarabine 100 mg/m^2 twice a day from Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
10791296|NCT01141712|OG000|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
10791297|NCT01141712|EG000|Reported Event|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
10791298|NCT01111305|BG000|Baseline|Reslizumab|"Reslizumab~Diethylcarbamazine"
10791299|NCT01111305|BG001|Baseline|Placebo|"Placebo~Diethylcarbamazine"
10791300|NCT01111305|BG002|Baseline|Total|Total of all reporting groups
11195353|NCT02158039|FG000|Participant Flow|Pancreatic Cyst Ethanol Injection|Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
11195354|NCT02158039|OG000|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
10791301|NCT01111305|FG000|Participant Flow|Reslizumab|"Reslizumab~Diethylcarbamazine"
10791302|NCT01111305|FG001|Participant Flow|Placebo|"Placebo~Diethylcarbamazine"
10791303|NCT01111305|OG000|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
10791304|NCT01111305|OG001|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
10791305|NCT01111305|OG000|Outcome|Reslizumab|"Reslizumab~Diethylcarbamazine"
10791306|NCT01111305|OG001|Outcome|Placebo|"Placebo~Diethylcarbamazine"
10791307|NCT01111305|EG000|Reported Event|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
10791308|NCT01111305|EG001|Reported Event|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
10802580|NCT03366428|FG000|Participant Flow|DS-8201a|Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
10802581|NCT03366428|OG000|Outcome|DS-8201a|Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.
10802582|NCT03366428|OG000|Outcome|HER2 Positive|Participants with HER2 positive expression (defined as immunohistochemistry 3+ or in situ hybridization positive) who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.
10802583|NCT03366428|OG001|Outcome|HER2 Low|Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.
10802584|NCT03366428|EG000|Reported Event|DS-8201a|Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.
10802585|NCT03221660|BG000|Baseline|F-Composite 2 System|"75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.~F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light."
10850749|NCT00304265|BG000|Baseline|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
10791309|NCT00659646|BG000|Baseline|Gentamicin Sponge|"Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours."
10791310|NCT00659646|BG001|Baseline|Levofloxacin|"Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours"
10791311|NCT00659646|BG002|Baseline|Total|Total of all reporting groups
10791312|NCT00659646|FG000|Participant Flow|Gentamicin-collagen Sponge and Levofloxacin|Gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.
10791313|NCT00659646|FG001|Participant Flow|Levofloxacin|Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
10791314|NCT00659646|OG000|Outcome|Gentamicin Sponge|"Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours."
10791315|NCT00659646|OG001|Outcome|Levofloxacin|"Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours"
10791316|NCT00659646|OG001|Outcome|No Sponge|"Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours"
10791317|NCT00659646|OG001|Outcome|No Sponge|"No Sponge~Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours"
10791318|NCT00659646|EG000|Reported Event|Gentamicin Sponge|"Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours."
10791319|NCT00659646|EG001|Reported Event|Levofloxacin|"Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing~Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours"
11383060|NCT02587520|BG008|Baseline|Adults: SP0173 Formulation 3|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383061|NCT02587520|BG009|Baseline|Adults: SP0173 Formulation 4|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
10966711|NCT00888459|OG001|Outcome|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
10966712|NCT00888459|EG000|Reported Event|Active|4 mg nicotine lozenges
11383062|NCT02587520|BG010|Baseline|Adults: Adacel®|Healthy participants aged 19-64 years received Adacel®.
11383063|NCT02587520|BG011|Baseline|Adults: Boostrix®|Healthy participants aged 19-64 years received Boostrix®.
11383064|NCT02587520|BG012|Baseline|Older Adults: SP0173 Formulation 1|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383065|NCT02587520|BG013|Baseline|Older Adults: SP0173 Formulation 2|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383066|NCT02587520|BG014|Baseline|Older Adults: SP0173 Formulation 3|Healthy subjects aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383067|NCT02587520|BG015|Baseline|Older Adults: SP0173 Formulation 4|Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383068|NCT02587520|BG016|Baseline|Older Adults: Adacel®|Healthy participants aged >=65 years received Adacel®.
11383069|NCT02587520|BG017|Baseline|Older Adults: Boostrix®|Healthy participants aged >=65 years received Boostrix®.
11383070|NCT02587520|BG018|Baseline|Total|Total of all reporting groups
11383071|NCT02587520|FG000|Participant Flow|Adolescents: SP0173 Formulation 1|Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
11383072|NCT02587520|FG001|Participant Flow|Adolescents: SP0173 Formulation 2|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383073|NCT02587520|FG002|Participant Flow|Adolescents: SP0173 Formulation 3|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383074|NCT02587520|FG003|Participant Flow|Adolescents: SP0173 Formulation 4|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383075|NCT02587520|FG004|Participant Flow|Adolescents: Adacel®|Healthy participants aged 10-18 years received Adacel®.
11383076|NCT02587520|FG005|Participant Flow|Adolescents: Boostrix®|Healthy participants aged 10-18 years received Boostrix®.
11383077|NCT02587520|FG006|Participant Flow|Adults: SP0173 Formulation 1|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383078|NCT02587520|FG007|Participant Flow|Adults: SP0173 Formulation 2|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383079|NCT02587520|FG008|Participant Flow|Adults: SP0173 Formulation 3|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
10791336|NCT00477412|BG000|Baseline|Phase I Bortezomib 0.7 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791337|NCT00477412|BG001|Baseline|Phase I Bortezomib 1.0 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791338|NCT00477412|BG002|Baseline|Phase 1 Maximum Tolerated Dose (MTD) 1.3 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10802586|NCT03221660|FG000|Participant Flow|F-Composite 2 System|"75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.~F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light."
11383080|NCT02587520|FG009|Participant Flow|Adults: SP0173 Formulation 4|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383081|NCT02587520|FG010|Participant Flow|Adults: Adacel®|Healthy participants aged 19-64 years received Adacel®.
11383082|NCT02587520|FG011|Participant Flow|Adults: Boostrix®|Healthy participants aged 19-64 years received Boostrix®.
11383083|NCT02587520|FG012|Participant Flow|Older Adults: SP0173 Formulation 1|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383084|NCT02587520|FG013|Participant Flow|Older Adults: SP0173 Formulation 2|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383085|NCT02587520|FG014|Participant Flow|Older Adults: SP0173 Formulation 3|Healthy subjects aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383086|NCT02587520|FG015|Participant Flow|Older Adults: SP0173 Formulation 4|Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383087|NCT02587520|FG016|Participant Flow|Older Adults: Adacel®|Healthy participants aged >=65 years received Adacel®.
11383088|NCT02587520|FG017|Participant Flow|Older Adults: Boostrix®|Healthy participants aged >=65 years received Boostrix®.
11383089|NCT02587520|OG000|Outcome|Adolescents: SP0173 Formulation 1|Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
11383090|NCT02587520|OG001|Outcome|Adolescents: SP0173 Formulation 2|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383091|NCT02587520|OG002|Outcome|Adolescents: SP0173 Formulation 3|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383092|NCT02587520|OG003|Outcome|Adolescents: SP0173 Formulation 4|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
11383093|NCT02587520|OG004|Outcome|Adolescents: Adacel®|Healthy participants aged 10-18 years received Adacel®.
11383094|NCT02587520|OG005|Outcome|Adolescents: Boostrix®|Healthy participants aged 10-18 years received Boostrix®.
11383095|NCT02587520|OG000|Outcome|Adults: SP0173 Formulation 1|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383096|NCT02587520|OG001|Outcome|Adults: SP0173 Formulation 2|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383097|NCT02587520|OG002|Outcome|Adults: SP0173 Formulation 3|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383098|NCT02587520|OG003|Outcome|Adults: SP0173 Formulation 4|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383099|NCT02587520|OG004|Outcome|Adults: Adacel®|Healthy participants aged 19-64 years received Adacel®.
11383100|NCT02587520|OG005|Outcome|Adults: Boostrix®|Healthy participants aged 19-64 years received Boostrix®.
11383101|NCT02587520|OG000|Outcome|Older Adults: SP0173 Formulation 1|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383102|NCT02587520|OG001|Outcome|Older Adults: SP0173 Formulation 2|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383103|NCT02587520|OG002|Outcome|Older Adults: SP0173 Formulation 3|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383104|NCT02587520|OG003|Outcome|Older Adults: SP0173 Formulation 4|Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
11383105|NCT02587520|OG004|Outcome|Older Adults: Adacel®|Healthy participants aged >=65 years received Adacel®.
10791339|NCT00477412|BG003|Baseline|Phase II- Treatment (Combination Chemotherapy)|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791340|NCT00477412|BG004|Baseline|Total|Total of all reporting groups
10791341|NCT00477412|FG000|Participant Flow|Phase I Bortezomib 0.7 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791342|NCT00477412|FG001|Participant Flow|Phase I Bortezomib 1.0 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791343|NCT00477412|FG002|Participant Flow|Phase 1 Maximum Tolerated Dose (MTD) 1.3 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791344|NCT00477412|FG003|Participant Flow|Phase II- Treatment (Combination Chemotherapy) 1.3 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791345|NCT00477412|OG000|Outcome|Phase 1 Maximum Tolerated Dose (MTD)|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791346|NCT00477412|OG000|Outcome|Phase II- Treatment (Combination Chemotherapy)|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10849946|NCT00299182|EG001|Reported Event|3 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10966713|NCT00888459|EG001|Reported Event|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
10849947|NCT00299182|EG002|Reported Event|10 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10791347|NCT00477412|EG000|Reported Event|Phase I Bortezomib 0.7 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791348|NCT00477412|EG001|Reported Event|Phase I Bortezomib 1.0 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791349|NCT00477412|EG002|Reported Event|Phase 1 Maximum Tolerated Dose (MTD) Bortezomib 1.3 mg/m^2|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791350|NCT00477412|EG003|Reported Event|Phase II- Treatment (Combination Chemotherapy)|"Participants receive Drug Combination I during courses 1, 3, 5, and 7 (if needed) and Drug Combination II during courses 2, 4, 6, and 8 (if needed) in the absence of disease progression or unacceptable toxicity.~Drug Combination I: Participants receive rituximab IV over 6 hours on day 1, cyclophosphamide IV over 3 hours BID on days 2-4, doxorubicin IV over 15-30 minutes on day 5, vincristine IV over 15-30 minutes on days 5 and 12, dexamethasone PO or IV on days 2-5 and 12-15, and bortezomib IV over a few seconds after the first dose of cyclophosphamide and immediately after vincristine and doxorubicin have been given on day 5.~Drug Combination II: Participants receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours every 12 hours on days 3-4."
10791351|NCT00369317|BG000|Baseline|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10791352|NCT00369317|FG000|Participant Flow|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10791353|NCT00369317|OG000|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
10850272|NCT00301067|OG000|Outcome|Temozolomide and Calcitriol (Cohort 1-3+Expansion)|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.2, 0.3, or 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
10966714|NCT00888511|BG000|Baseline|Concurrent Tarceva and RT in LA-NSCLC|"Tarceva: Tarceva 150 mg/day~Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks"
11383106|NCT02587520|OG005|Outcome|Older Adults: Boostrix®|Healthy participants aged >=65 years received Boostrix®.
11383107|NCT02587520|EG000|Reported Event|Adolescents: SP0173 Formulation 1|Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
10791354|NCT00369317|OG000|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10791355|NCT00369317|EG000|Reported Event|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
10791356|NCT00261807|BG000|Baseline|Single ARM Study|"It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.~Daptomycin 6mg/kg/day"
10791357|NCT00261807|FG000|Participant Flow|Single ARM Study|"It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.~Daptomycin 6mg/kg/day"
10791358|NCT00261807|OG000|Outcome|Single ARM Study|"It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.~Daptomycin 6mg/kg/day"
10791359|NCT00261807|OG000|Outcome|Single ARM Study|"It was a single arm study with higher dose of daptomycin used for patients with severe skin and soft tissue infections.~Daptomycin 6mg/kg/day"
10791360|NCT00261807|EG000|Reported Event|Single ARM Study|"It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.~Daptomycin 6mg/kg/day"
10802587|NCT03221660|OG000|Outcome|F-Composite 2 System|"75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling.~F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light."
10802588|NCT03221660|EG000|Reported Event|F-Composite 2 System|"Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system.~F-Composite 2 system: Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light."
10802589|NCT03131219|BG000|Baseline|Complement Inhibitor Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802590|NCT03131219|BG001|Baseline|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802591|NCT03131219|BG002|Baseline|Total|Total of all reporting groups
10802592|NCT03131219|FG000|Participant Flow|Complement Inhibitor Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802593|NCT03131219|FG001|Participant Flow|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802594|NCT03131219|OG000|Outcome|Complement Inhibitor Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802595|NCT03131219|OG001|Outcome|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802596|NCT03131219|EG000|Reported Event|Complement Inhibitor Treatment Naïve|Complement inhibitor treatment-naïve participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10802597|NCT03131219|EG001|Reported Event|Eculizumab Experienced|Eculizumab-experienced participants received weight-based doses of ravulizumab during the 26-week Initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participants continued their weight-based maintenance dose of ravulizumab.
10791361|NCT04964193|BG000|Baseline|Total Number of Participants|All participants received 2 mg cyproterone acetate + 0.035 mg ethinylestradiol tablet (new and marketed)
10791362|NCT04964193|FG000|Participant Flow|Test Drug First, Then Reference Drug|New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and marketed (reference) Diane®-35 sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).
10791363|NCT04964193|FG001|Participant Flow|Diane-35 Sugar-coated Tablet|Marketed (reference) Diane-35 Sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and new (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).
10791364|NCT04964193|OG000|Outcome|Elzsa Film-coated Tablet|"Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water~Elzsa film-coated tablet: Administered with 240 mL of water"
10791365|NCT04964193|OG001|Outcome|Diane-35 Sugar-coated Tablet|"Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water~Diane-35 Sugar-coated tablet: Administered with 240 mL of water"
10791366|NCT04964193|EG000|Reported Event|Elzsa Film-coated Tablet|New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.
10791367|NCT04964193|EG001|Reported Event|Diane-35 Sugar-coated Tablet|Marketed (reference) Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.
10791368|NCT04826731|BG000|Baseline|Incentive Spirometer Group|"Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under Incentive Spirometer Group.~Incentive Spirometer/Respiratory Exerciser: A patient is considered acceptable for the Incentive Spirometer Group if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device."
10791369|NCT04826731|BG001|Baseline|Standard Care Group|"Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under Standard Care Group."
10791370|NCT04826731|BG002|Baseline|Total|Total of all reporting groups
10791371|NCT04826731|FG000|Participant Flow|Incentive Spirometer Group|"Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under Incentive Spirometer Group.~Incentive Spirometer/Respiratory Exerciser: A patient is considered acceptable for the Incentive Spirometer Group if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device."
10791372|NCT04826731|FG001|Participant Flow|Standard Care Group|"Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under Standard Care Group."
10791373|NCT04826731|OG000|Outcome|Incentive Spirometer Group|"Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under Incentive Spirometer Group.~Incentive Spirometer/Respiratory Exerciser: A patient is considered acceptable for the Incentive Spirometer Group if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device."
10791374|NCT04826731|OG001|Outcome|Standard Care Group|"Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under Standard Care Group."
10791375|NCT04826731|EG000|Reported Event|Incentive Spirometer Group|"Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under Incentive Spirometer Group.~Incentive Spirometer/Respiratory Exerciser: A patient is considered acceptable for the Incentive Spirometer Group if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device."
11195355|NCT02158039|EG000|Reported Event|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
10791376|NCT04826731|EG001|Reported Event|Standard Care Group|"Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under Standard Care Group."
10791377|NCT04620798|BG000|Baseline|Intervention (Immediate Results)|Participants will be given their results of their antibody test immediately (within 24 hours).
10791378|NCT04620798|BG001|Baseline|Control (Delayed Results)|Participants will be given their results of their antibody test four weeks following the test.
10791379|NCT04620798|BG002|Baseline|Total|Total of all reporting groups
10791380|NCT04620798|FG000|Participant Flow|Intervention (Immediate Results)|Participants will be given their results of their antibody test immediately (within 24 hours).
10791381|NCT04620798|FG001|Participant Flow|Control (Delayed Results)|Participants will be given their results of their antibody test four weeks following the test.
10791382|NCT04620798|OG000|Outcome|Intervention (Immediate Results)|Participants will be given their results of their antibody test immediately (within 24 hours).
10791383|NCT04620798|OG001|Outcome|Control (Delayed Results)|Participants will be given their results of their antibody test four weeks following the test.
10791384|NCT04620798|EG000|Reported Event|Intervention (Immediate Results)|Participants will be given their results of their antibody test immediately (within 24 hours).
10791385|NCT04620798|EG001|Reported Event|Control (Delayed Results)|Participants will be given their results of their antibody test four weeks following the test.
11339982|NCT03643575|FG003|Participant Flow|Treatment Sequence 4|"Period 1: Treatment A~Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment B~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
10791386|NCT04507321|BG000|Baseline|GSK3640254 Tablet+[14C]-GSK3640254 IV/ [14C]-GSK3640254 Oral Suspension|Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. In Treatment Period 2 on Day 1, participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal. The treatment periods were separated by a washout period of at least 13 days between oral doses.
10791387|NCT04507321|FG000|Participant Flow|GSK3640254 Tablet+[14C]-GSK3640254 IV/ [14C]-GSK3640254 Oral Suspension|Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. In Treatment Period 2 on Day 1, participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal. The treatment periods were separated by a washout period of at least 13 days between oral doses.
10791388|NCT04507321|OG000|Outcome|GSK3640254 Tablet|Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1
10791389|NCT04507321|OG000|Outcome|[14C]-GSK3640254 IV|Eligible participants received an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.
10791390|NCT04507321|OG000|Outcome|[14C]-GSK3640254 IV|Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1
10791391|NCT04507321|OG000|Outcome|[14C]-GSK3640254 Oral Suspension|Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2
10791392|NCT04507321|OG000|Outcome|GSK3640254 Tablet|Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1
10791393|NCT04507321|OG000|Outcome|[14C]-GSK3640254 IV|Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.
10791394|NCT04507321|OG000|Outcome|GSK3640254 Tablet + [14C]-GSK3640254 IV|Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.
10791395|NCT04507321|OG001|Outcome|[14C]-GSK3640254 Oral Suspension|Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.
10791396|NCT04507321|OG000|Outcome|[14C]-GSK3640254 Oral Suspension|Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.
10791397|NCT04507321|EG000|Reported Event|GSK3640254 Tablet+[14C]-GSK3640254 IV|Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. The treatment periods were separated by a washout period of at least 13 days between oral doses.
10791398|NCT04507321|EG001|Reported Event|[14C]-GSK3640254 Oral Suspension|Participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal in Treatment Period 2 on Day 1. The treatment periods were separated by a washout period of at least 13 days between oral doses.
10802598|NCT03075527|BG000|Baseline|Tremelimumab + Durvalumab|"Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.~Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.~Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells."
10802599|NCT03075527|FG000|Participant Flow|Tremelimumab + Durvalumab|"Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.~Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.~Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells."
10802600|NCT03075527|OG000|Outcome|Tremelimumab + Durvalumab|"Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.~Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.~Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells."
10802601|NCT03075527|EG000|Reported Event|Tremelimumab + Durvalumab|"Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.~Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.~Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells."
11383108|NCT02587520|EG001|Reported Event|Adolescents: SP0173 Formulation 2|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
10802602|NCT02756611|BG000|Baseline|Venetoclax|Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
10802603|NCT02756611|FG000|Participant Flow|Venetoclax|Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
10966715|NCT00888511|FG000|Participant Flow|Concurrent Tarceva and RT in LA-NSCLC|"Tarceva: Tarceva 150 mg/day~Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks"
10791399|NCT04256629|BG000|Baseline|Treatment Sequence ABC|Randomised participants received single doses of all 3 study treatments (Treatment A: Verinurad 24 mg extended release [ER8] formulation co-administered with 300 mg allopurinol, Treatment B: Verinurad 40 mg immediate release [IR] formulation co-administered with 300 mg allopurinol, and Treatment C: Matching placebos for both verinurad and allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791400|NCT04256629|BG001|Baseline|Treatment Sequence BCA|Randomised participants received single doses of all 3 study treatments (Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, Treatment C: Matching placebos for both verinurad and allopurinol, and Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791401|NCT04256629|BG002|Baseline|Treatment Sequence CAB|Randomised participants received single doses of all 3 study treatments (Treatment C: Matching placebos for both verinurad and allopurinol, Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, and Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791402|NCT04256629|BG003|Baseline|Treatment Sequence ACB|Randomised participants received single doses of all 3 study treatments ( Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, Treatment C: Matching placebos for both verinurad and allopurinol, and Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791403|NCT04256629|BG004|Baseline|Treatment Sequence BAC|Randomised participants received single doses of all 3 study treatments (Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, and Treatment C: Matching placebos for both verinurad and allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791404|NCT04256629|BG005|Baseline|Treatment Sequence CBA|Randomised participants received single doses of all 3 study treatments (Treatment C: Matching placebos for both verinurad and allopurinol, Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, and Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791405|NCT04256629|BG006|Baseline|Total|Total of all reporting groups
10791406|NCT04256629|FG000|Participant Flow|Treatment Sequence ABC|Randomised participants received single doses of all 3 study treatments (Treatment A: Verinurad 24 mg extended release [ER8] formulation co-administered with 300 mg allopurinol, Treatment B: Verinurad 40 mg immediate release [IR] formulation co-administered with 300 mg allopurinol, and Treatment C: Matching placebos for both verinurad and allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791407|NCT04256629|FG001|Participant Flow|Treatment Sequence BCA|Randomised participants received single doses of all 3 study treatments (Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, Treatment C: Matching placebos for both verinurad and allopurinol, and Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791408|NCT04256629|FG002|Participant Flow|Treatment Sequence CAB|Randomised participants received single doses of all 3 study treatments (Treatment C: Matching placebos for both verinurad and allopurinol, Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, and Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791409|NCT04256629|FG003|Participant Flow|Treatment Sequence ACB|Randomised participants received single doses of all 3 study treatments ( Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, Treatment C: Matching placebos for both verinurad and allopurinol, and Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791410|NCT04256629|FG004|Participant Flow|Treatment Sequence BAC|Randomised participants received single doses of all 3 study treatments (Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol, and Treatment C: Matching placebos for both verinurad and allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791411|NCT04256629|FG005|Participant Flow|Treatment Sequence CBA|Randomised participants received single doses of all 3 study treatments (Treatment C: Matching placebos for both verinurad and allopurinol, Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol, and Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol) in a cross-over design with wash-out periods of at least 7 days between each study dose administration under fasted conditions.
10791412|NCT04256629|OG000|Outcome|Treatment A|Participants received a single dose of verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol
10791413|NCT04256629|OG001|Outcome|Treatment B|Participants received a single dose of verinurad 40 mg IR formulation co-administered with 300 mg allopurinol
10791414|NCT04256629|OG002|Outcome|Treatment C|Participants received matching placebos for both verinurad and allopurinol
11195356|NCT02158247|BG000|Baseline|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
11195357|NCT02158247|BG001|Baseline|Touch and Read Group(Female)|female
10791415|NCT04256629|EG000|Reported Event|Treatment A|Participants received a single dose of verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol
10791416|NCT04256629|EG001|Reported Event|Treatment B|Participants received a single dose of verinurad 40 mg IR formulation co-administered with 300 mg allopurinol
10791417|NCT04256629|EG002|Reported Event|Treatment C|Participants received matching placebos for both verinurad and allopurinol
10791418|NCT04174521|BG000|Baseline|Mother-Child|Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
10791419|NCT04174521|FG000|Participant Flow|Mother-Child|Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
10791420|NCT04174521|OG000|Outcome|Mother-Child|Mothers-child pairs whose delivery occurred at VUMC and who are seen by Vanderbilt-affiliated physicians.
10791421|NCT04174521|EG000|Reported Event|Mother-Child|Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
10791422|NCT04014075|BG000|Baseline|Trastuzumab Deruxtecan|Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
10791423|NCT04014075|FG000|Participant Flow|Trastuzumab Deruxtecan|Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
10791424|NCT04014075|OG000|Outcome|Trastuzumab Deruxtecan|Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
10791425|NCT04014075|EG000|Reported Event|Trastuzumab Deruxtecan|Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
10791426|NCT03284853|BG000|Baseline|Netarsudil/Latanoprost 0.02%/0.005%|"PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.~Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution"
10791427|NCT03284853|BG001|Baseline|GANFORT®|"GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.~GANFORT®: Topical sterile ophthalmic solution"
10791428|NCT03284853|BG002|Baseline|Total|Total of all reporting groups
11195358|NCT02158247|BG002|Baseline|Total|Total of all reporting groups
11383109|NCT02587520|EG002|Reported Event|Adolescents: SP0173 Formulation 3|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
10791429|NCT03284853|FG000|Participant Flow|Netarsudil/Latanoprost 0.02%/0.005%|"PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.~Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution"
10791430|NCT03284853|FG001|Participant Flow|GANFORT®|"GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.~GANFORT®: Topical sterile ophthalmic solution"
10791431|NCT03284853|OG000|Outcome|Netarsudil/Latanoprost 0.02%/0.005%|"PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.~Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution"
10791432|NCT03284853|OG001|Outcome|GANFORT®|"GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.~GANFORT®: Topical sterile ophthalmic solution"
10791433|NCT03284853|EG000|Reported Event|Netarsudil/Latanoprost 0.02%/0.005%|"PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.~Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution"
10791434|NCT03284853|EG001|Reported Event|GANFORT®|"GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.~GANFORT®: Topical sterile ophthalmic solution"
10802604|NCT02756611|OG000|Outcome|Venetoclax|Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
10802605|NCT02756611|EG000|Reported Event|Venetoclax|Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 2 additional years.
10802606|NCT02724878|BG000|Baseline|Bevacizumab And Atezolizumab Combination|"1200 mg of Atezolizumab intravenously x 3 weeks~15 mg/kg of Bevacizumab intravenously x 3 weeks.~One cycle will be 3 weeks in duration."
10802607|NCT02724878|FG000|Participant Flow|Bevacizumab And Atezolizumab Combination|"1200 mg of Atezolizumab intravenously x 3 weeks~15 mg/kg of Bevacizumab intravenously x 3 weeks.~One cycle will be 3 weeks in duration."
10802608|NCT02724878|OG000|Outcome|Bevacizumab And Atezolizumab Combination|"1200 mg of Atezolizumab intravenously x 3 weeks~15 mg/kg of Bevacizumab intravenously x 3 weeks.~One cycle will be 3 weeks in duration."
10802609|NCT02724878|EG000|Reported Event|Bevacizumab And Atezolizumab Combination|"1200 mg of Atezolizumab intravenously x 3 weeks~15 mg/kg of Bevacizumab intravenously x 3 weeks.~One cycle will be 3 weeks in duration."
10802610|NCT02605993|BG000|Baseline|Cohort 1|"During the Treatment Period, participants were administered ravulizumab 1400 mg on Day 1, ravulizumab 1000 mg on Day 15 and Day 29, and then ravulizumab 1000 mg every 4 weeks for 7 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10966716|NCT00888511|OG000|Outcome|Concurrent Tarceva and RT in LA-NSCLC|"Tarceva: Tarceva 150 mg/day~Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks"
11383110|NCT02587520|EG003|Reported Event|Adolescents: SP0173 Formulation 4|Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
10791435|NCT03032250|BG000|Baseline|Group I Supportive Care (Prepare to Care Kit)|"Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.~Communication Intervention: Attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791436|NCT03032250|BG001|Baseline|Group II Control Group|"Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791437|NCT03032250|BG002|Baseline|Total|Total of all reporting groups
10791438|NCT03032250|FG000|Participant Flow|Group I Supportive Care (Prepare to Care Kit)|"Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.~Communication Intervention: Attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791439|NCT03032250|FG001|Participant Flow|Group II Control Group|"Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791440|NCT03032250|OG000|Outcome|Group I Supportive Care (Prepare to Care Kit)|"Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.~Communication Intervention: Attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791441|NCT03032250|OG000|Outcome|All Participants|"Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.~Communication Intervention: Attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791442|NCT03032250|OG001|Outcome|Group II No Interventionist Sessions|"Caregivers receive educational intervention as in Group I but do not attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791443|NCT03032250|OG000|Outcome|Combination of Intervention and Control Groups to Assess Participation|Participation assessed by proportion of eligible participants who agreed to participate
10791444|NCT03032250|EG000|Reported Event|Group I Supportive Care (Prepare to Care Kit)|"Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.~Communication Intervention: Attend interventionist sessions~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10965755|NCT00883688|FG000|Participant Flow|Bevacizumab + Lapatinib|"Bevacizumab 10 mg/kg intravenous over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week study cycle). Lapatinib 700 mg/m^2/dose given orally 2 times each day."
10791445|NCT03032250|EG001|Reported Event|Group II Control Group|"Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.~Watch video: Watch video on a DVD~Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated."
10791446|NCT02942966|BG000|Baseline|Tack Endovascular System (4F)|Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
10791447|NCT02942966|FG000|Participant Flow|Tack Endovascular System (4F)|Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
10791448|NCT02942966|OG000|Outcome|Tack Endovascular System (4F)|Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
10791449|NCT02942966|EG000|Reported Event|Tack Endovascular System (4F)|Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
10791450|NCT02774889|BG000|Baseline|Stepping Online|Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.
10791451|NCT02774889|BG001|Baseline|Stepping On 'Usual Care'|Control Stepping On graduates did not have access to Stepping Online.
10791452|NCT02774889|BG002|Baseline|Total|Total of all reporting groups
10791453|NCT02774889|FG000|Participant Flow|Stepping Online|"Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes:~Fall prevention tips~Fall prevention exercise videos with narrations for proper technique and safety precautions~Guest expert videos with online access to the guest expert to ask questions~Tools to set exercise goals, reminders and track progress~Fall prevention specialist for feedback and group activities~Discussion and messaging (1:1, small and large group)~Fall prevention resources."
10791454|NCT02774889|FG001|Participant Flow|Stepping On Usual Care Control|Control Stepping On graduates did not have access to Stepping Online.
10791455|NCT02774889|OG000|Outcome|Stepping Online|Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.
10791456|NCT02774889|OG001|Outcome|Stepping On 'Usual Care'|Control Stepping On graduates did not have access to Stepping Online.
10791457|NCT02774889|OG001|Outcome|Stepping On Usual Care Control|Subjects control workshops in the condition will not have access to Stepping Online.
10791458|NCT02774889|OG001|Outcome|Stepping On Usual Care Control|Control Stepping On graduates did not have access to Stepping Online.
10791459|NCT02774889|EG000|Reported Event|Stepping Online|"Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes:~Fall prevention tips~Fall prevention exercise videos with narrations for proper technique and safety precautions~Guest expert videos with online access to the guest expert to ask questions~Tools to set exercise goals, reminders and track progress~Fall prevention specialist for feedback and group activities~Discussion and messaging (1:1, small and large group)~Fall prevention resources."
10791460|NCT02774889|EG001|Reported Event|Stepping On Usual Care Control|Control Stepping On graduates did not have access to Stepping Online.
11383111|NCT02587520|EG004|Reported Event|Adolescents: Adacel®|Healthy participants aged 10-18 years received Adacel®.
10791461|NCT02721069|BG000|Baseline|NRL-1|"Intranasal dose of NRL-1 will be administered at either 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight.~NRL-1"
10791462|NCT02721069|FG000|Participant Flow|NRL-1|"Intranasal dose of NRL-1 will be administered at either 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight.~NRL-1"
10791463|NCT02721069|OG000|Outcome|NRL-1 5mg|Intranasal dose of NRL-1 will be administered at 5 mg based on age and weight.
10791464|NCT02721069|OG001|Outcome|NRL-1 10mg|Intranasal dose of NRL-1 will be administered at 10 mg based on age and weight.
10791465|NCT02721069|OG002|Outcome|NRL-1 15 mg|Intranasal dose of NRL-1 will be administered at 15 mg based on age and weight.
10791466|NCT02721069|OG003|Outcome|NRL-1 20mg|Intranasal dose of NRL-1 will be administered at 20 mg based on age and weight.
10791467|NCT02721069|EG000|Reported Event|NRL-1 5mg|Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight.
10791468|NCT02721069|EG001|Reported Event|NRL-1 10mg|Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight.
10791469|NCT02721069|EG002|Reported Event|NRL-1 15mg|Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight.
10791470|NCT02721069|EG003|Reported Event|NRL-1 20mg|Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight.
10791471|NCT02297438|BG000|Baseline|Palbociclib + Letrozole|Participants were planned to receive palbociclib 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for palbociclib and for letrozole were 1872 days and 1872 days, respectively.
10791472|NCT02297438|BG001|Baseline|Placebo + Letrozole|Participants were planned to receive placebo 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for placebo and for letrozole were 1834 days and 1834 days, respectively.
10791473|NCT02297438|BG002|Baseline|Total|Total of all reporting groups
10791474|NCT02297438|FG000|Participant Flow|Palbociclib + Letrozole|Participants were planned to receive palbociclib 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for palbociclib and for letrozole were 1872 days and 1872 days, respectively.
11383112|NCT02587520|EG005|Reported Event|Adolescents: Boostrix®|Healthy participants aged 10-18 years received Boostrix®.
11383113|NCT02587520|EG006|Reported Event|Adults: SP0173 Formulation 1|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383114|NCT02587520|EG007|Reported Event|Adults: SP0173 Formulation 2|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383115|NCT02587520|EG008|Reported Event|Adults: SP0173 Formulation 3|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383116|NCT02587520|EG009|Reported Event|Adults: SP0173 Formulation 4|Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
11383117|NCT02587520|EG010|Reported Event|Adults: Adacel®|Healthy participants aged 19-64 years received Adacel®.
11383118|NCT02587520|EG011|Reported Event|Adults: Boostrix®|Healthy participants aged 19-64 years received Boostrix®.
11383119|NCT02587520|EG012|Reported Event|Older Adults: SP0173 Formulation 1|Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383120|NCT02587520|EG013|Reported Event|Older Adults: SP0173 Formulation 2|Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383121|NCT02587520|EG014|Reported Event|Older Adults: SP0173 Formulation 3|Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383122|NCT02587520|EG015|Reported Event|Older Adults: SP0173 Formulation 4|Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
11383123|NCT02587520|EG016|Reported Event|Older Adults: Adacel®|Healthy participants aged >= 65 years received Adacel®.
11383124|NCT02587520|EG017|Reported Event|Older Adults: Boostrix®|Healthy participants aged >= 65 years received Boostrix®.
11383125|NCT02584829|BG000|Baseline|Group 1 (Avelumab and MHC Class I Up-regulation)|"Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383126|NCT02584829|BG001|Baseline|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|"Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383127|NCT02584829|BG002|Baseline|Total|Total of all reporting groups
11383128|NCT02584829|FG000|Participant Flow|Group 1 (Avelumab and MHC Class I Up-regulation)|"Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383129|NCT02584829|FG001|Participant Flow|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|"Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383130|NCT02584829|OG000|Outcome|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|"Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383131|NCT02584829|OG000|Outcome|Group 1 (Avelumab and MHC Class I Up-regulation)|"Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383132|NCT02584829|OG001|Outcome|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|"Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
10791475|NCT02297438|FG001|Participant Flow|Placebo + Letrozole|Participants were planned to receive placebo 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for placebo and for letrozole were 1834 days and 1834 days, respectively.
10791476|NCT02297438|OG000|Outcome|Palbociclib + Letrozole|Participants were planned to receive palbociclib 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for palbociclib and for letrozole were 1872 days and 1872 days, respectively.
10791477|NCT02297438|OG001|Outcome|Placebo + Letrozole|Participants were planned to receive placebo 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for placebo and for letrozole were 1834 days and 1834 days, respectively.
10791478|NCT02297438|EG000|Reported Event|Palbociclib + Letrozole|Participants were planned to receive palbociclib 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for palbociclib and for letrozole were 1872 days and 1872 days, respectively.
10791479|NCT02297438|EG001|Reported Event|Placebo + Letrozole|Participants were planned to receive placebo 125 mg orally once a day (QD) for 21 days of every 28-day cycle followed by 7 days off treatment together with letrozole 2.5 mg orally QD continuously. The maximum duration of treatment for placebo and for letrozole were 1834 days and 1834 days, respectively.
10791480|NCT02297412|BG000|Baseline|Arm I (Minocycline Hydrochloride)|Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791481|NCT02297412|BG001|Baseline|Arm II (Placebo)|Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791482|NCT02297412|BG002|Baseline|Total|Total of all reporting groups
10791483|NCT02297412|FG000|Participant Flow|Arm I (Minocycline Hydrochloride)|Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791484|NCT02297412|FG001|Participant Flow|Arm II (Placebo)|Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791485|NCT02297412|OG000|Outcome|Arm I (Minocycline Hydrochloride)|Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791486|NCT02297412|OG001|Outcome|Arm II (Placebo)|Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791487|NCT02297412|EG000|Reported Event|Arm I (Minocycline Hydrochloride)|Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11339983|NCT03643575|FG004|Participant Flow|Treatment Sequence 5|"Period 1: Treatment B~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment A~Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
10791488|NCT02297412|EG001|Reported Event|Arm II (Placebo)|Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10791489|NCT02292758|BG000|Baseline|Arm I (Irinotecan, Cetuximab, Bevacizumab)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791490|NCT02292758|BG001|Baseline|Arm II (Irinotecan, Cetuximab, Placebo)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791491|NCT02292758|BG002|Baseline|Total|Total of all reporting groups
10791492|NCT02292758|FG000|Participant Flow|Arm I (Irinotecan, Cetuximab, Bevacizumab)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791493|NCT02292758|FG001|Participant Flow|Arm II (Irinotecan, Cetuximab, Placebo)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791494|NCT02292758|OG000|Outcome|Arm I (Irinotecan, Cetuximab, Bevacizumab)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791495|NCT02292758|OG001|Outcome|Arm II (Irinotecan, Cetuximab, Placebo)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791496|NCT02292758|EG000|Reported Event|Arm I (Irinotecan, Cetuximab, Bevacizumab)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10791497|NCT02292758|EG001|Reported Event|Arm II (Irinotecan, Cetuximab, Placebo)|Patients receive 500 mg/m^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10966717|NCT00888511|EG000|Reported Event|Concurrent Tarceva and RT in LA-NSCLC|"Tarceva: Tarceva 150 mg/day~Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks"
10791498|NCT02250326|BG000|Baseline|Nab-Paclitaxel + CC-486 Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791499|NCT02250326|BG001|Baseline|Nab-Paclitaxel + Durvalumab Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791500|NCT02250326|BG002|Baseline|Nab-Paclitaxel Monotherapy Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791501|NCT02250326|BG003|Baseline|Total|Total of all reporting groups
10791502|NCT02250326|FG000|Participant Flow|Nab-Paclitaxel + CC-486 Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791503|NCT02250326|FG001|Participant Flow|Nab-Paclitaxel + Durvalumab Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791504|NCT02250326|FG002|Participant Flow|Nab-Paclitaxel Monotherapy Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791505|NCT02250326|OG000|Outcome|Nab-Paclitaxel + CC-486 Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791506|NCT02250326|OG001|Outcome|Nab-Paclitaxel + Durvalumab Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11195359|NCT02158247|FG000|Participant Flow|Tough and Read Group|"This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
11195360|NCT02158247|OG000|Outcome|Airway Length for Male|
11195361|NCT02158247|OG001|Outcome|Airway Length of Female|
11195362|NCT02158247|OG000|Outcome|Conventional Method for Risk Group of Male|
11195363|NCT02158247|OG001|Outcome|Touch and Read for Risk Group of Male|
10791507|NCT02250326|OG002|Outcome|Nab-Paclitaxel Alone|Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
11195364|NCT02158247|OG000|Outcome|Conventional Method for Normal Group of Male|
10791508|NCT02250326|OG000|Outcome|Nab-Paclitaxel + Durvalumab Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791509|NCT02250326|EG000|Reported Event|Nab-Paclitaxel + CC-486 Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791510|NCT02250326|EG001|Reported Event|Nab-Paclitaxel + Durvalumab Combination Arm|Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10791511|NCT02250326|EG002|Reported Event|Nab-Paclitaxel Monotherapy Arm|Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
10850273|NCT00301067|EG000|Reported Event|Cohort 1 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11195365|NCT02158247|OG001|Outcome|Touch and Read for Normal Group of Male|
11195366|NCT02158247|OG000|Outcome|Conventional Method for Risk Group of Female|
11195367|NCT02158247|OG001|Outcome|Touch and Read for Risk Group of Female|
10791512|NCT01856270|BG000|Baseline|Amitriptyline Immediate|"The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
10791513|NCT01856270|BG001|Baseline|Amitriptyline Delayed|"The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and then reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
10791514|NCT01856270|BG002|Baseline|Total|Total of all reporting groups
10791515|NCT01856270|FG000|Participant Flow|Amitriptyline Immediate|"The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when receiving initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance/distribute study drug) and Day 90 (final outcome)."
10791516|NCT01856270|FG001|Participant Flow|Amitriptyline Delayed|"The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.~Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and Day 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome)."
10791517|NCT01856270|OG000|Outcome|Amitriptyline Sample|Individuals enrolled into the study and who have completed headache diaries through 3 months post injury.
10791518|NCT01856270|OG000|Outcome|Amitriptyline Study|Individuals enrolled into the current study.
10791519|NCT01856270|OG000|Outcome|Amitriptyline Immediate|The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
10791520|NCT01856270|OG001|Outcome|Amitriptyline Delayed|The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
10791521|NCT01856270|EG000|Reported Event|Amitriptyline Immediate|The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
10791522|NCT01856270|EG001|Reported Event|Amitriptyline Delayed|The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening to assess whether there is any cognitive impact of the medication (comparing to those who started immediately after enrollment. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
10791523|NCT01503515|BG000|Baseline|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Optional correlative studies"
10791524|NCT01503515|BG001|Baseline|Arm II (Fluconazole or Voriconazole)|"Patients receive fluconazole IV over 1-2 hours QD or PO QD; or voriconazole IV over 1-2 hours QD or PO BID beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Optional correlative studies~Voriconazole: Given IV or PO"
10791525|NCT01503515|BG002|Baseline|Total|Total of all reporting groups
10791526|NCT01503515|FG000|Participant Flow|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Optional correlative studies"
11195368|NCT02158247|OG000|Outcome|Conventional Method for Normal Group of Female|
11195369|NCT02158247|OG001|Outcome|Touch and Read for Normal Group of Female|
11195370|NCT02158247|OG000|Outcome|Airway Length vs Height in Male|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
10791527|NCT01503515|FG001|Participant Flow|Arm II (Fluconazole or Voriconazole)|"Patients receive fluconazole IV over 1-2 hours QD or PO QD; or voriconazole IV over 1-2 hours QD or PO BID beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Optional correlative studies~Voriconazole: Given IV or PO"
10791528|NCT01503515|OG000|Outcome|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Optional correlative studies"
10791529|NCT01503515|OG001|Outcome|Arm II (Fluconazole or Voriconazole)|"Patients receive fluconazole IV over 1-2 hours QD or PO QD; or voriconazole IV over 1-2 hours QD or PO BID beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Optional correlative studies~Voriconazole: Given IV or PO"
10791530|NCT01503515|EG000|Reported Event|Arm I (Caspofungin Acetate)|"Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Caspofungin Acetate: Given IV~Laboratory Biomarker Analysis: Optional correlative studies"
10791531|NCT01503515|EG001|Reported Event|Arm II (Fluconazole or Voriconazole)|"Patients receive fluconazole IV over 1-2 hours QD or PO QD; or voriconazole IV over 1-2 hours QD or PO BID beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.~Fluconazole: Given IV or PO~Laboratory Biomarker Analysis: Optional correlative studies~Voriconazole: Given IV or PO"
10791532|NCT01491893|BG000|Baseline|Recombinant Nonpathogenic Polio-Rhinovirus Chimera (PVSRIPO)|All participants who received a dose of PVSRIPO at any dose level
10791533|NCT01491893|FG000|Participant Flow|Dose Level 1 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791534|NCT01491893|FG001|Participant Flow|Dose Level 2 (Dose Escalation)|Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791535|NCT01491893|FG002|Participant Flow|Dose Level 3 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791536|NCT01491893|FG003|Participant Flow|Dose Level 4 (Dose Escalation)|Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791537|NCT01491893|FG004|Participant Flow|Dose Level 5 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791538|NCT01491893|FG005|Participant Flow|Dose Level 4 (Dose De-escalation)|Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791539|NCT01491893|FG006|Participant Flow|Dose Level 2 (Dose Expansion)|Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791540|NCT01491893|FG007|Participant Flow|Dose Level -1 (Dose Expansion)|Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791541|NCT01491893|FG008|Participant Flow|Dose Level -2 (Dose Expansion)|Participants received a single intratumoral infusion of 1.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791542|NCT01491893|FG009|Participant Flow|Dose Level -1 (Selected Dose Expansion)|Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791543|NCT01491893|OG000|Outcome|Dose Escalation Patients|Dose Escalation Patients
10791544|NCT01491893|OG000|Outcome|Dose Level 1 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791545|NCT01491893|OG001|Outcome|Dose Level 2 (Dose Escalation)|Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791546|NCT01491893|OG002|Outcome|Dose Level 3 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791547|NCT01491893|OG003|Outcome|Dose Level 4 (Dose Escalation)|Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791548|NCT01491893|OG004|Outcome|Dose Level 5 (Dose Escalation)|Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791549|NCT01491893|OG000|Outcome|All Participants|All Participants
10791550|NCT01491893|EG000|Reported Event|Dose Level 1 Patients|Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791551|NCT01491893|EG001|Reported Event|Dose Level 2 Patients|Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791552|NCT01491893|EG002|Reported Event|Dose Level 3 Patients|Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791553|NCT01491893|EG003|Reported Event|Dose Level 4 Patients|Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791554|NCT01491893|EG004|Reported Event|Dose Level 5 Patients|Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791555|NCT01491893|EG005|Reported Event|Dose Level -1 Patients|Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791556|NCT01491893|EG006|Reported Event|Dose Level -2 Patients|Participants received a single intratumoral infusion of 1.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
10791557|NCT00245960|BG000|Baseline|Etanercept BIW/QW|Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791558|NCT00245960|BG001|Baseline|Etanercept QW/QW|Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791559|NCT00245960|BG002|Baseline|Total|Total of all reporting groups
10791560|NCT00245960|FG000|Participant Flow|Etanercept BIW/QW|Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791561|NCT00245960|FG001|Participant Flow|Etanercept QW/QW|Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791562|NCT00245960|OG000|Outcome|Etanercept BIW/QW|Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791563|NCT00245960|OG001|Outcome|Etanercept QW/QW|Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791564|NCT00245960|EG000|Reported Event|Etanercept BIW/QW|Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10791565|NCT00245960|EG001|Reported Event|Etanercept QW/QW|Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
10802611|NCT02605993|BG001|Baseline|Cohort 2|"During the Treatment Period, participants were administered ravulizumab 2000 mg on Day 1, ravulizumab 1600 mg on Day 22 and Day 43, and then ravulizumab 1600 mg every 6 weeks for 4 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802612|NCT02605993|BG002|Baseline|Cohort 3|"During the Treatment Period, participants were administered ravulizumab 1600 mg on Day 1 and Day 15, ravulizumab 2400 mg on Day 29, and then ravulizumab 2400 mg every 8 weeks for 3 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
11195371|NCT02158247|OG000|Outcome|Female Airway Length vs Height|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
10802613|NCT02605993|BG003|Baseline|Cohort 4|"During the Treatment Period, participants were administered ravulizumab 3000 mg on Day 1, ravulizumab 5400 mg on Day 29, and then ravulizumab 5400 mg every 12 weeks for 2 doses.~During the Extension Period, participants were administered ravulizumab 5400 mg every 12 weeks for up to 5 years."
10802614|NCT02605993|BG004|Baseline|Total|Total of all reporting groups
10802615|NCT02605993|FG000|Participant Flow|Cohort 1|"During the Treatment Period, participants were administered ravulizumab 1400 milligrams (mg) on Day 1, ravulizumab 1000 mg on Day 15 and Day 29, and then ravulizumab 1000 mg every 4 weeks for 7 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kilograms (kg), 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802616|NCT02605993|FG001|Participant Flow|Cohort 2|"During the Treatment Period, participants were administered ravulizumab 2000 mg on Day 1, ravulizumab 1600 mg on Day 22 and Day 43, and then ravulizumab 1600 mg every 6 weeks for 4 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802617|NCT02605993|FG002|Participant Flow|Cohort 3|"During the Treatment Period, participants were administered ravulizumab 1600 mg on Day 1 and Day 15, ravulizumab 2400 mg on Day 29, and then ravulizumab 2400 mg every 8 weeks for 3 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802618|NCT02605993|FG003|Participant Flow|Cohort 4|"During the Treatment Period, participants were administered ravulizumab 3000 mg on Day 1, ravulizumab 5400 mg on Day 29, and then ravulizumab 5400 mg every 12 weeks for 2 doses.~During the Extension Period, participants were administered ravulizumab 5400 mg every 12 weeks for up to 5 years."
10965756|NCT00883688|OG000|Outcome|Bevacizumab + Lapatinib|"Bevacizumab 10 mg/kg intravenous over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week study cycle). Lapatinib 700 mg/m^2/dose given orally 2 times each day."
10791566|NCT04565353|BG000|Baseline|Holdout Control|Participants will only receive the standard appointment reminders from their providers.
10791567|NCT04565353|BG001|Baseline|Default Reservations Opt-Out Condition|"The day before their scheduled appointment, participants receive a text reading: A flu shot has been reserved for you to receive at your appointment tomorrow. Reply Y if you want this shot held for you, N if you don't. The text will include a picture of a vial that says Your Flu Shot on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791568|NCT04565353|BG002|Baseline|Default Reservations Opt-In Condition|"The day before their scheduled appointment, participants receive a text reading: Reply Y if you would like to receive a flu shot at your appointment tomorrow, N if not. The text will include a picture of vial with no text on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791569|NCT04565353|BG003|Baseline|Intergroup Competition Treatment Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind another region in flu shot rate last year (your region and another region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791570|NCT04565353|BG004|Baseline|Intergroup Competition Control Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind the target flu shot rate of 70% last year (your region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791571|NCT04565353|BG005|Baseline|Flu Shot for You Symbolic Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity to dedicate getting the flu shot to someone by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791572|NCT04565353|BG006|Baseline|Flu Shot for You Herd Immunity Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity of getting the flu shot to protect a vulnerable loved one by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791573|NCT04565353|BG007|Baseline|Flu Shot for You Control Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also receive a reminder message on the day of the appointment. They will not receive any further information, nor will they be asked to respond with initials of an individual.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791574|NCT04565353|BG008|Baseline|Prosocial Condition|"The day before their scheduled appointment, participants will receive a message describing the pro-social benefits of getting a flu shot, and a reminder to ask for their flu shot. The described pro-social benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting loved ones from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting loved ones from serious complications from the flu). Participants will also receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791575|NCT04565353|BG009|Baseline|Self-Oriented Condition|"The day before their scheduled appointment, participants will receive a message describing the self-oriented benefits of getting a flu shot, and a reminder to ask for their flu shot. The described self-oriented benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting oneself from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting oneself from serious complications from the flu).~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11339984|NCT03643575|FG005|Participant Flow|Treatment Sequence 6|"Period 1: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment B~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment A~Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
10791576|NCT04565353|BG010|Baseline|Information Vivid Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain vivid information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791577|NCT04565353|BG011|Baseline|Information Basic Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain basic information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791578|NCT04565353|BG012|Baseline|Information Control Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain information about exercising. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791579|NCT04565353|BG013|Baseline|Sharing Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791580|NCT04565353|BG014|Baseline|No Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791581|NCT04565353|BG015|Baseline|Healthy Habits Easy Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of easy health behaviors (e.g., whether they walked 500 feet yesterday, at least two serving of fruits and vegetables in the last week, and slept at least 6 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791582|NCT04565353|BG016|Baseline|Healthy Habits Difficult Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of difficult health behaviors (e.g., whether they walked 3 miles yesterday, ate 4-6 servings of fruits and vegetables yesterday, and slept at least 9 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791583|NCT04565353|BG017|Baseline|Healthy Habits Control Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791584|NCT04565353|BG018|Baseline|Just-In-Time Reminders 24-Hour Condition|"Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 24 hours before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791585|NCT04565353|BG019|Baseline|Just-In-Time Reminders 15-Minute Condition|"Just-In-Time Reminders 15-Minute Condition: Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 15 minutes before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791586|NCT04565353|BG020|Baseline|Total|Total of all reporting groups
10791587|NCT04565353|FG000|Participant Flow|Holdout Control|Participants will only receive the standard appointment reminders from their providers.
10791588|NCT04565353|FG001|Participant Flow|Default Reservations Opt-Out Condition|"The day before their scheduled appointment, participants receive a text reading: A flu shot has been reserved for you to receive at your appointment tomorrow. Reply Y if you want this shot held for you, N if you don't. The text will include a picture of a vial that says Your Flu Shot on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791589|NCT04565353|FG002|Participant Flow|Default Reservations Opt-In Condition|"The day before their scheduled appointment, participants receive a text reading: Reply Y if you would like to receive a flu shot at your appointment tomorrow, N if not. The text will include a picture of vial with no text on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195372|NCT02158247|EG000|Reported Event|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
10791590|NCT04565353|FG003|Participant Flow|Intergroup Competition Treatment Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind another region in flu shot rate last year (your region and another region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791591|NCT04565353|FG004|Participant Flow|Intergroup Competition Control Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind the target flu shot rate of 70% last year (your region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791592|NCT04565353|FG005|Participant Flow|Flu Shot for You Symbolic Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity to dedicate getting the flu shot to someone by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195373|NCT02158247|EG001|Reported Event|Touch and Read Group(Female)|female
11195374|NCT02158273|BG000|Baseline|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
10791593|NCT04565353|FG006|Participant Flow|Flu Shot for You Herd Immunity Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity of getting the flu shot to protect a vulnerable loved one by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791594|NCT04565353|FG007|Participant Flow|Flu Shot for You Control Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also receive a reminder message on the day of the appointment. They will not receive any further information, nor will they be asked to respond with initials of an individual.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791595|NCT04565353|FG008|Participant Flow|Prosocial Condition|"The day before their scheduled appointment, participants will receive a message describing the pro-social benefits of getting a flu shot, and a reminder to ask for their flu shot. The described pro-social benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting loved ones from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting loved ones from serious complications from the flu). Participants will also receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791596|NCT04565353|FG009|Participant Flow|Self-Oriented Condition|"The day before their scheduled appointment, participants will receive a message describing the self-oriented benefits of getting a flu shot, and a reminder to ask for their flu shot. The described self-oriented benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting oneself from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting oneself from serious complications from the flu).~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791597|NCT04565353|FG010|Participant Flow|Information Vivid Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain vivid information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791598|NCT04565353|FG011|Participant Flow|Information Basic Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain basic information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791599|NCT04565353|FG012|Participant Flow|Information Control Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain information about exercising. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791600|NCT04565353|FG013|Participant Flow|Sharing Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791601|NCT04565353|FG014|Participant Flow|No Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791602|NCT04565353|FG015|Participant Flow|Healthy Habits Easy Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of easy health behaviors (e.g., whether they walked 500 feet yesterday, at least two serving of fruits and vegetables in the last week, and slept at least 6 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791603|NCT04565353|FG016|Participant Flow|Healthy Habits Difficult Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of difficult health behaviors (e.g., whether they walked 3 miles yesterday, ate 4-6 servings of fruits and vegetables yesterday, and slept at least 9 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791604|NCT04565353|FG017|Participant Flow|Healthy Habits Control Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791605|NCT04565353|FG018|Participant Flow|Just-In-Time Reminders 24-Hour Condition|"Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 24 hours before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195375|NCT02158273|BG001|Baseline|Placebo|Matched Placebo
10791606|NCT04565353|FG019|Participant Flow|Just-In-Time Reminders 15-Minute Condition|"Just-In-Time Reminders 15-Minute Condition: Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 15 minutes before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791607|NCT04565353|OG000|Outcome|Holdout Control|Participants will only receive the standard appointment reminders from their providers.
10791608|NCT04565353|OG001|Outcome|Default Reservations Opt-Out Condition|"The day before their scheduled appointment, participants receive a text reading: A flu shot has been reserved for you to receive at your appointment tomorrow. Reply Y if you want this shot held for you, N if you don't. The text will include a picture of a vial that says Your Flu Shot on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791609|NCT04565353|OG002|Outcome|Default Reservations Opt-In Condition|"The day before their scheduled appointment, participants receive a text reading: Reply Y if you would like to receive a flu shot at your appointment tomorrow, N if not. The text will include a picture of vial with no text on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195376|NCT02158273|BG002|Baseline|Total|Total of all reporting groups
11195377|NCT02158273|FG000|Participant Flow|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
11195378|NCT02158273|FG001|Participant Flow|Placebo|Matched Placebo
10791610|NCT04565353|OG003|Outcome|Intergroup Competition Treatment Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind another region in flu shot rate last year (your region and another region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791611|NCT04565353|OG004|Outcome|Intergroup Competition Control Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind the target flu shot rate of 70% last year (your region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791612|NCT04565353|OG005|Outcome|Flu Shot for You Symbolic Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity to dedicate getting the flu shot to someone by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791613|NCT04565353|OG006|Outcome|Flu Shot for You Herd Immunity Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity of getting the flu shot to protect a vulnerable loved one by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791614|NCT04565353|OG007|Outcome|Flu Shot for You Control Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also receive a reminder message on the day of the appointment. They will not receive any further information, nor will they be asked to respond with initials of an individual.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791615|NCT04565353|OG008|Outcome|Prosocial Condition|"The day before their scheduled appointment, participants will receive a message describing the pro-social benefits of getting a flu shot, and a reminder to ask for their flu shot. The described pro-social benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting loved ones from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting loved ones from serious complications from the flu). Participants will also receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791616|NCT04565353|OG009|Outcome|Self-Oriented Condition|"The day before their scheduled appointment, participants will receive a message describing the self-oriented benefits of getting a flu shot, and a reminder to ask for their flu shot. The described self-oriented benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting oneself from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting oneself from serious complications from the flu).~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195379|NCT02158273|OG000|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
10791617|NCT04565353|OG010|Outcome|Information Vivid Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain vivid information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791618|NCT04565353|OG011|Outcome|Information Basic Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain basic information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791619|NCT04565353|OG012|Outcome|Information Control Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain information about exercising. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791620|NCT04565353|OG013|Outcome|Sharing Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791621|NCT04565353|OG014|Outcome|No Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791622|NCT04565353|OG015|Outcome|Healthy Habits Easy Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of easy health behaviors (e.g., whether they walked 500 feet yesterday, at least two serving of fruits and vegetables in the last week, and slept at least 6 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10850919|NCT03651622|BG000|Baseline|Hypocaloric, Low Carbohydrate|Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
11195380|NCT02158273|OG001|Outcome|Placebo|Matched Placebo
11195381|NCT02158273|EG000|Reported Event|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
10791623|NCT04565353|OG016|Outcome|Healthy Habits Difficult Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of difficult health behaviors (e.g., whether they walked 3 miles yesterday, ate 4-6 servings of fruits and vegetables yesterday, and slept at least 9 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791624|NCT04565353|OG017|Outcome|Healthy Habits Control Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791625|NCT04565353|OG018|Outcome|Just-In-Time Reminders 24-Hour Condition|"Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 24 hours before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791626|NCT04565353|OG019|Outcome|Just-In-Time Reminders 15-Minute Condition|"Just-In-Time Reminders 15-Minute Condition: Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 15 minutes before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791627|NCT04565353|EG000|Reported Event|Holdout Control|Participants will only receive the standard appointment reminders from their providers.
10791628|NCT04565353|EG001|Reported Event|Default Reservations Opt-Out Condition|"The day before their scheduled appointment, participants receive a text reading: A flu shot has been reserved for you to receive at your appointment tomorrow. Reply Y if you want this shot held for you, N if you don't. The text will include a picture of a vial that says Your Flu Shot on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11195382|NCT02158273|EG001|Reported Event|Placebo|Matched Placebo
10791629|NCT04565353|EG002|Reported Event|Default Reservations Opt-In Condition|"The day before their scheduled appointment, participants receive a text reading: Reply Y if you would like to receive a flu shot at your appointment tomorrow, N if not. The text will include a picture of vial with no text on it.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791630|NCT04565353|EG003|Reported Event|Intergroup Competition Treatment Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind another region in flu shot rate last year (your region and another region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791631|NCT04565353|EG004|Reported Event|Intergroup Competition Control Condition|"Three days before their scheduled appointment, participants will receive a text message with information about how much your region lagged behind the target flu shot rate of 70% last year (your region will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791632|NCT04565353|EG005|Reported Event|Flu Shot for You Symbolic Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity to dedicate getting the flu shot to someone by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791633|NCT04565353|EG006|Reported Event|Flu Shot for You Herd Immunity Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity of getting the flu shot to protect a vulnerable loved one by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791634|NCT04565353|EG007|Reported Event|Flu Shot for You Control Condition|"Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also receive a reminder message on the day of the appointment. They will not receive any further information, nor will they be asked to respond with initials of an individual.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791635|NCT04565353|EG008|Reported Event|Prosocial Condition|"The day before their scheduled appointment, participants will receive a message describing the pro-social benefits of getting a flu shot, and a reminder to ask for their flu shot. The described pro-social benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting loved ones from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting loved ones from serious complications from the flu). Participants will also receive a reminder message on the day of the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791636|NCT04565353|EG009|Reported Event|Self-Oriented Condition|"The day before their scheduled appointment, participants will receive a message describing the self-oriented benefits of getting a flu shot, and a reminder to ask for their flu shot. The described self-oriented benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting oneself from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting oneself from serious complications from the flu).~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10850920|NCT03651622|BG001|Baseline|Hypocaloric, Moderate Low Fat|Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10791637|NCT04565353|EG010|Reported Event|Information Vivid Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain vivid information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791638|NCT04565353|EG011|Reported Event|Information Basic Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain basic information about getting the flu. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791639|NCT04565353|EG012|Reported Event|Information Control Condition|"Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain information about exercising. Participants will also receive a reminder message the day before the appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791640|NCT04565353|EG013|Reported Event|Sharing Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791641|NCT04565353|EG014|Reported Event|No Humor Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791642|NCT04565353|EG015|Reported Event|Healthy Habits Easy Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of easy health behaviors (e.g., whether they walked 500 feet yesterday, at least two serving of fruits and vegetables in the last week, and slept at least 6 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
11339985|NCT03643575|OG000|Outcome|Treatment A|Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791643|NCT04565353|EG016|Reported Event|Healthy Habits Difficult Health Behavior Condition|"The day before their scheduled appointment, participants will be asked if they have completed a series of difficult health behaviors (e.g., whether they walked 3 miles yesterday, ate 4-6 servings of fruits and vegetables yesterday, and slept at least 9 hours the previous night). They will then be encouraged to get a flu shot at their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791644|NCT04565353|EG017|Reported Event|Healthy Habits Control Condition|"The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791645|NCT04565353|EG018|Reported Event|Just-In-Time Reminders 24-Hour Condition|"Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 24 hours before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791646|NCT04565353|EG019|Reported Event|Just-In-Time Reminders 15-Minute Condition|"Just-In-Time Reminders 15-Minute Condition: Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 15 minutes before their appointment.~Flu shot text messages: Participants will receive text messages per descriptions listed in the arms."
10791647|NCT04015336|BG000|Baseline|Arm 1-3x10^10 E7 T-Cell Receptor (TCR) T Cells|"Up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (based on the number of cells that can be generated in the shortened manufacturing process) will be administered intravenously over 20 to 30 minutes on day 0.~E7 T-Cell Receptor (TCR): The dose of E7 T-Cell Receptor (TCR) T cells will be 3 x 10^10 TCR+ T cells (unless fewer cells are generated) administered once."
10791648|NCT04015336|FG000|Participant Flow|Arm 1-3x10^10 E7 T-Cell Receptor (TCR) T Cells|"Up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (based on the number of cells that can be generated in the shortened manufacturing process) will be administered intravenously over 20 to 30 minutes on day 0.~E7 T-Cell Receptor (TCR): The dose of E7 T-Cell Receptor (TCR) T cells will be 3 x 10^10 TCR+ T cells (unless fewer cells are generated) administered once."
10791649|NCT04015336|OG000|Outcome|Arm 1-3x10^10 E7 T-Cell Receptor (TCR) T Cells|"Up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (based on the number of cells that can be generated in the shortened manufacturing process) will be administered intravenously over 20 to 30 minutes on day 0.~E7 T-Cell Receptor (TCR): The dose of E7 T-Cell Receptor (TCR) T cells will be 3 x 10^10 TCR+ T cells (unless fewer cells are generated) administered once."
10791650|NCT04015336|EG000|Reported Event|Arm 1-3x10^10 E7 T-Cell Receptor (TCR) T Cells|"Up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (based on the number of cells that can be generated in the shortened manufacturing process) will be administered intravenously over 20 to 30 minutes on day 0.~E7 T-Cell Receptor (TCR): The dose of E7 T-Cell Receptor (TCR) T cells will be 3 x 10^10 TCR+ T cells (unless fewer cells are generated) administered once."
10802619|NCT02605993|OG000|Outcome|Cohort 1|"During the Treatment Period, participants were administered ravulizumab 1400 mg on Day 1, ravulizumab 1000 mg on Day 15 and Day 29, and then ravulizumab 1000 mg every 4 weeks for 7 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10791651|NCT03972813|BG000|Baseline|Cervical Cancer - Sexually Transmitted (STD) - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791652|NCT03972813|BG001|Baseline|Cervical Cancer - STD - 12 Years Old (y.o.)|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791653|NCT03972813|BG002|Baseline|Cervical Cancer - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791654|NCT03972813|BG003|Baseline|Cervical Cancer - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791655|NCT03972813|BG004|Baseline|Cervical Cancer - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791656|NCT03972813|BG005|Baseline|Cervical Cancer - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791657|NCT03972813|BG006|Baseline|Cervical Cancer - Blank - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791658|NCT03972813|BG007|Baseline|Cervical Cancer - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791659|NCT03972813|BG008|Baseline|Cervical Cancer - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791660|NCT03972813|BG009|Baseline|Many Cancers - STD - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791661|NCT03972813|BG010|Baseline|Many Cancers - STD - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10850274|NCT00301067|EG001|Reported Event|Cohort 2 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
10791662|NCT03972813|BG011|Baseline|Many Cancers - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791663|NCT03972813|BG012|Baseline|Many Cancers - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791664|NCT03972813|BG013|Baseline|Many Cancers - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791665|NCT03972813|BG014|Baseline|Many Cancers - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791666|NCT03972813|BG015|Baseline|Many Cancers - Blank - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791667|NCT03972813|BG016|Baseline|Many Cancers - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791668|NCT03972813|BG017|Baseline|Many Cancers - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791669|NCT03972813|BG018|Baseline|Total|Total of all reporting groups
10791670|NCT03972813|FG000|Participant Flow|Cervical Cancer - Sexually Transmitted (STD) - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791671|NCT03972813|FG001|Participant Flow|Cervical Cancer - STD - 12 Years Old (y.o.)|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791672|NCT03972813|FG002|Participant Flow|Cervical Cancer - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10965757|NCT00883688|EG000|Reported Event|Bevacizumab + Lapatinib|"Bevacizumab 10 mg/kg intravenous over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week study cycle). Lapatinib 700 mg/m^2/dose given orally 2 times each day."
11339986|NCT03643575|OG001|Outcome|Treatment B|Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791673|NCT03972813|FG003|Participant Flow|Cervical Cancer - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791674|NCT03972813|FG004|Participant Flow|Cervical Cancer - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791675|NCT03972813|FG005|Participant Flow|Cervical Cancer - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791676|NCT03972813|FG006|Participant Flow|Cervical Cancer - Blank - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791677|NCT03972813|FG007|Participant Flow|Cervical Cancer - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791678|NCT03972813|FG008|Participant Flow|Cervical Cancer - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791679|NCT03972813|FG009|Participant Flow|Many Cancers - STD - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791680|NCT03972813|FG010|Participant Flow|Many Cancers - STD - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791681|NCT03972813|FG011|Participant Flow|Many Cancers - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791682|NCT03972813|FG012|Participant Flow|Many Cancers - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10965758|NCT00883740|BG000|Baseline|Entire Study Population|Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
11195383|NCT02158364|BG000|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
11339987|NCT03643575|OG002|Outcome|Treatment C|Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791683|NCT03972813|FG013|Participant Flow|Many Cancers - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791684|NCT03972813|FG014|Participant Flow|Many Cancers - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791685|NCT03972813|FG015|Participant Flow|Many Cancers - Blank - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791686|NCT03972813|FG016|Participant Flow|Many Cancers - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791687|NCT03972813|FG017|Participant Flow|Many Cancers - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791688|NCT03972813|OG000|Outcome|Cervical Cancer - Sexually Transmitted (STD) - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791689|NCT03972813|OG001|Outcome|Cervical Cancer - STD - 12 Years Old (y.o.)|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791690|NCT03972813|OG002|Outcome|Cervical Cancer - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791691|NCT03972813|OG003|Outcome|Cervical Cancer - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791692|NCT03972813|OG004|Outcome|Cervical Cancer - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791693|NCT03972813|OG005|Outcome|Cervical Cancer - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791694|NCT03972813|OG006|Outcome|Cervical Cancer - Blank - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791695|NCT03972813|OG007|Outcome|Cervical Cancer - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791696|NCT03972813|OG008|Outcome|Cervical Cancer - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791697|NCT03972813|OG009|Outcome|Many Cancers - STD - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791698|NCT03972813|OG010|Outcome|Many Cancers - STD - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791699|NCT03972813|OG011|Outcome|Many Cancers - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791700|NCT03972813|OG012|Outcome|Many Cancers - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791701|NCT03972813|OG013|Outcome|Many Cancers - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791702|NCT03972813|OG014|Outcome|Many Cancers - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791703|NCT03972813|OG015|Outcome|Many Cancers - Blank - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791704|NCT03972813|OG016|Outcome|Many Cancers - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791705|NCT03972813|OG017|Outcome|Many Cancers - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791706|NCT03972813|EG000|Reported Event|Cervical Cancer - Sexually Transmitted (STD) - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791707|NCT03972813|EG001|Reported Event|Cervical Cancer - STD - 12 Years Old (y.o.)|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791708|NCT03972813|EG002|Reported Event|Cervical Cancer - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791709|NCT03972813|EG003|Reported Event|Cervical Cancer - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791710|NCT03972813|EG004|Reported Event|Cervical Cancer - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791711|NCT03972813|EG005|Reported Event|Cervical Cancer - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer."
10791712|NCT03972813|EG006|Reported Event|Cervical Cancer - Blank - Standard|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791713|NCT03972813|EG007|Reported Event|Cervical Cancer - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791714|NCT03972813|EG008|Reported Event|Cervical Cancer - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Cervical cancer: Caregivers are told that HPV causes cervical cancer.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791715|NCT03972813|EG009|Reported Event|Many Cancers - STD - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10850750|NCT00304265|BG001|Baseline|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
10791716|NCT03972813|EG010|Reported Event|Many Cancers - STD - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791717|NCT03972813|EG011|Reported Event|Many Cancers - STD - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about STDs: Caregivers learn that HPV is an STD.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791718|NCT03972813|EG012|Reported Event|Many Cancers - Infectious - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations."
10791719|NCT03972813|EG013|Reported Event|Many Cancers - Infectious - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old."
10791720|NCT03972813|EG014|Reported Event|Many Cancers - Infectious - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old."
10791721|NCT03972813|EG015|Reported Event|Many Cancers - Blank - Standard|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791722|NCT03972813|EG016|Reported Event|Many Cancers - Blank - 12 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
11195384|NCT02158364|FG000|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
10791723|NCT03972813|EG017|Reported Event|Many Cancers - Blank - 18 y.o.|"The Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system.~Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.~Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.~Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.~Blank information about communicability: Caregivers are not given any information on how HPV is spread."
10791724|NCT03920280|BG000|Baseline|Biofinity|Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10791725|NCT03920280|BG001|Baseline|LID015385|LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10791726|NCT03920280|BG002|Baseline|Total|Total of all reporting groups
10791727|NCT03920280|FG000|Participant Flow|Biofinity|Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10791728|NCT03920280|FG001|Participant Flow|LID015385|LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10850751|NCT00304265|BG002|Baseline|Total|Total of all reporting groups
11195385|NCT02158364|OG000|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
10791729|NCT03920280|OG000|Outcome|Biofinity|Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10791730|NCT03920280|OG001|Outcome|LID015385|LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
10791731|NCT03920280|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
10791732|NCT03920280|EG001|Reported Event|Biofinity - Ocular|Events reported in this group occurred while exposed to the comfilcon A contact lenses
10791733|NCT03920280|EG002|Reported Event|Biofinity - Nonocular/Systemic|Events reported in this group occurred while exposed to the comfilcon A contact lenses
10791734|NCT03920280|EG003|Reported Event|LID015385 - Ocular|Events reported in this group occurred while exposed to the LID015385 contact lenses
10791735|NCT03920280|EG004|Reported Event|LID015385 - Nonocular/Systemic|Events reported in this group occurred while exposed to the LID015385 contact lenses
11195386|NCT02158364|EG000|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. Participants received interventions as part of routine medical care.
11195387|NCT02158442|BG000|Baseline|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
10791736|NCT03913091|BG000|Baseline|20 mL 0.5% Bupivacaine HCL|0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
10791737|NCT03913091|BG001|Baseline|Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%|"Administered in an Interscalene block for TSA~Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL"
10791738|NCT03913091|BG002|Baseline|Total|Total of all reporting groups
10791739|NCT03913091|FG000|Participant Flow|20 mL 0.5% Bupivacaine HCL|0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
10791740|NCT03913091|FG001|Participant Flow|Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%|"Administered in an Interscalene block for TSA~Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL"
10791741|NCT03913091|OG000|Outcome|20 mL 0.5% Bupivacaine HCL|0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
10791742|NCT03913091|OG001|Outcome|Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%|"Administered in an Interscalene block for TSA~Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL"
10791743|NCT03913091|EG000|Reported Event|20 mL 0.5% Bupivacaine HCL|0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
10791744|NCT03913091|EG001|Reported Event|Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%|"Administered in an Interscalene block for TSA~Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL"
10791745|NCT03802565|BG000|Baseline|Tolperisone 50 mg|"TID (150 mg/day)~Tolperisone: TID"
10791746|NCT03802565|BG001|Baseline|Tolperisone 100 mg|"TID (300 mg/day)~Tolperisone: TID"
10791747|NCT03802565|BG002|Baseline|Tolperisone 150 mg|"TID (450 mg/day)~Tolperisone: TID"
10791748|NCT03802565|BG003|Baseline|Tolperisone 200 mg|"TID (600 mg/day)~Tolperisone: TID"
10791749|NCT03802565|BG004|Baseline|Placebo|"TID~Placebo: Placebo"
10791750|NCT03802565|BG005|Baseline|Total|Total of all reporting groups
10791751|NCT03802565|FG000|Participant Flow|Tolperisone 50 mg|"TID (150 mg/day)~Tolperisone: TID"
10791752|NCT03802565|FG001|Participant Flow|Tolperisone 100 mg|"TID (300 mg/day)~Tolperisone: TID"
10791753|NCT03802565|FG002|Participant Flow|Tolperisone 150 mg|"TID (450 mg/day)~Tolperisone: TID"
10791754|NCT03802565|FG003|Participant Flow|Tolperisone 200 mg|"TID (600 mg/day)~Tolperisone: TID"
10791755|NCT03802565|FG004|Participant Flow|Placebo|"TID~Placebo: Placebo"
10791756|NCT03802565|OG000|Outcome|Tolperisone 50 mg|"TID (150 mg/day)~Tolperisone: TID"
10791757|NCT03802565|OG001|Outcome|Tolperisone 100 mg|"TID (300 mg/day)~Tolperisone: TID"
10791758|NCT03802565|OG002|Outcome|Tolperisone 150 mg|"TID (450 mg/day)~Tolperisone: TID"
10791759|NCT03802565|OG003|Outcome|Tolperisone 200 mg|"TID (600 mg/day)~Tolperisone: TID"
10791760|NCT03802565|OG004|Outcome|Placebo|"TID~Placebo: Placebo"
10791761|NCT03802565|EG000|Reported Event|Tolperisone 50 mg|"TID (150 mg/day)~Tolperisone: TID"
10791762|NCT03802565|EG001|Reported Event|Tolperisone 100 mg|"TID (300 mg/day)~Tolperisone: TID"
10791763|NCT03802565|EG002|Reported Event|Tolperisone 150 mg|"TID (450 mg/day)~Tolperisone: TID"
10791764|NCT03802565|EG003|Reported Event|Tolperisone 200 mg|"TID (600 mg/day)~Tolperisone: TID"
10791765|NCT03802565|EG004|Reported Event|Placebo|"TID~Placebo: Placebo"
10791766|NCT03769194|BG000|Baseline|VLA15 Low Dose|"VLA15 low dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791767|NCT03769194|BG001|Baseline|VLA15 Medium Dose|"VLA15 medium dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791768|NCT03769194|BG002|Baseline|VLA15 High Dose|"VLA15 high dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791769|NCT03769194|BG003|Baseline|Placebo|Placebo: Placebo: PBS (Phosphate Buffered Saline)
10791770|NCT03769194|BG004|Baseline|Total|Total of all reporting groups
10791771|NCT03769194|FG000|Participant Flow|VLA15 Low Dose|"VLA15 low dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791772|NCT03769194|FG001|Participant Flow|VLA15 Medium Dose|"VLA15 medium dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791773|NCT03769194|FG002|Participant Flow|VLA15 High Dose|"VLA15 high dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791774|NCT03769194|FG003|Participant Flow|Placebo|Placebo: Placebo: PBS (Phosphate Buffered Saline)
10791775|NCT03769194|OG000|Outcome|VLA15 Low Dose|"VLA15 low dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791776|NCT03769194|OG001|Outcome|VLA15 Medium Dose|"VLA15 medium dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791777|NCT03769194|OG002|Outcome|VLA15 High Dose|"VLA15 high dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791778|NCT03769194|OG003|Outcome|Placebo|Placebo: Placebo: PBS (Phosphate Buffered Saline)
10791779|NCT03769194|EG000|Reported Event|VLA15 Low Dose|"VLA15 low dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791780|NCT03769194|EG001|Reported Event|VLA15 Medium Dose|"VLA15 medium dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
11195388|NCT02158442|BG001|Baseline|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
11195389|NCT02158442|BG002|Baseline|Total|Total of all reporting groups
11195390|NCT02158442|FG000|Participant Flow|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
11195391|NCT02158442|FG001|Participant Flow|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
11195392|NCT02158442|OG000|Outcome|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
11195393|NCT02158442|OG001|Outcome|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
10791781|NCT03769194|EG002|Reported Event|VLA15 High Dose|"VLA15 high dose with Alum.~VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate"
10791782|NCT03769194|EG003|Reported Event|Placebo|Placebo: Placebo: PBS (Phosphate Buffered Saline)
10791783|NCT03738332|BG000|Baseline|Low-level Laser Therapy|"Single arm~Low-Level Laser: Low-level laser therapy"
10791784|NCT03738332|FG000|Participant Flow|Low-level Laser Therapy|"Single arm~Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)"
10791785|NCT03738332|OG000|Outcome|Low-level Laser Therapy|"Single arm~Low-Level Laser: Low-level laser therapy"
10791786|NCT03738332|OG000|Outcome|Low-level Laser Therapy|"Single arm~Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)"
10791787|NCT03738332|EG000|Reported Event|Low-level Laser Therapy|"Single arm~Low-Level Laser: Low-level laser therapy"
10791788|NCT03451786|BG000|Baseline|Treatment Group|IOL: Intraocular lens
10791789|NCT03451786|FG000|Participant Flow|Treatment Group|IOL: Intraocular lens
10791790|NCT03451786|OG000|Outcome|Treatment Group|IOL: Intraocular lens
10791791|NCT03451786|EG000|Reported Event|Treatment Group|IOL: Intraocular lens
10791792|NCT03416179|BG000|Baseline|Intensive Study: Glasdegib + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with less than (<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m^2) IV for adults greater than or equals to (>=) 60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791793|NCT03416179|BG001|Baseline|Intensive Study: Placebo + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with <5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m^2 IV for adults >=60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive CR MRD-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10850752|NCT00304265|FG000|Participant Flow|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
11195394|NCT02158442|EG000|Reported Event|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
11195395|NCT02158442|EG001|Reported Event|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
11195396|NCT02158494|BG000|Baseline|Neurostimulation|Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).
11195397|NCT02158494|BG001|Baseline|Control (Non-zero, Minimally Perceivable Stimulation)|Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).
10791794|NCT03416179|BG002|Baseline|Non-intensive Study: Glasdegib + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 subcutaneous (SC) injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791795|NCT03416179|BG003|Baseline|Non-intensive Study: Placebo + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791796|NCT03416179|BG004|Baseline|Total|Total of all reporting groups
10791797|NCT03416179|FG000|Participant Flow|Intensive Study: Glasdegib + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with less than (<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m^2) IV for adults greater than or equals to (>=) 60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791798|NCT03416179|FG001|Participant Flow|Intensive Study: Placebo + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with <5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m^2 IV for adults >=60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive CR MRD-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791799|NCT03416179|FG002|Participant Flow|Non-intensive Study: Glasdegib + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 subcutaneous (SC) injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791800|NCT03416179|FG003|Participant Flow|Non-intensive Study: Placebo + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10802620|NCT02605993|OG001|Outcome|Cohort 2|"During the Treatment Period, participants were administered ravulizumab 2000 mg on Day 1, ravulizumab 1600 mg on Day 22 and Day 43, and then ravulizumab 1600 mg every 6 weeks for 4 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
11195398|NCT02158494|BG002|Baseline|Total|Total of all reporting groups
10791801|NCT03416179|OG000|Outcome|Intensive Study: Glasdegib + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with less than (<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m^2) IV for adults greater than or equals to (>=) 60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791802|NCT03416179|OG001|Outcome|Intensive Study: Placebo + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with <5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m^2 IV for adults >=60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive CR MRD-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791803|NCT03416179|OG000|Outcome|Non-intensive Study: Glasdegib + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 subcutaneous (SC) injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791804|NCT03416179|OG001|Outcome|Non-intensive Study: Placebo + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791805|NCT03416179|EG000|Reported Event|Intensive Study: Glasdegib + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with less than (<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m^2) IV for adults greater than or equals to (>=) 60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10802621|NCT02605993|OG002|Outcome|Cohort 3|"During the Treatment Period, participants were administered ravulizumab 1600 mg on Day 1 and Day 15, ravulizumab 2400 mg on Day 29, and then ravulizumab 2400 mg every 8 weeks for 3 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802622|NCT02605993|OG003|Outcome|Cohort 4|"During the Treatment Period, participants were administered ravulizumab 3000 mg on Day 1, ravulizumab 5400 mg on Day 29, and then ravulizumab 5400 mg every 12 weeks for 2 doses.~During the Extension Period, participants were administered ravulizumab 5400 mg every 12 weeks for up to 5 years."
11339988|NCT03643575|EG000|Reported Event|Treatment A|Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791806|NCT03416179|EG001|Reported Event|Intensive Study: Placebo + Cytarabine + Daunorubicin|Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m^2 IV daily for 5 days and daunorubicin 60 mg/m^2 IV daily for 2 days. Participants with <5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m^2 IV for adults >=60 to <60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction and up to 2 years post randomization or until 2 consecutive CR MRD-negative central laboratory results, whichever came first. Participants were to be followed up for first 2 years from last dose and were to had long term survival follow-up for up to 5 years from randomization of last participant or until death/consent withdrawal.
10791807|NCT03416179|EG002|Reported Event|Non-intensive Study: Glasdegib + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 subcutaneous (SC) injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
10791808|NCT03416179|EG003|Reported Event|Non-intensive Study: Placebo + Azacitidine|Participants received chemotherapy with azacitidine 75 mg/m^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo up to 2 years following randomization unless 2 consecutive negative MRD assessments. Participants were to be followed up for first 2 years from last dose of drug and were to had long term follow-up for survival for up to 5 years from randomization of last participant in study, or until death, or consent withdrawal.
11195399|NCT02158494|FG000|Participant Flow|Neurostimulation|Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training)
10791809|NCT03353922|BG000|Baseline|All Study Participants|All Study Participants; n=33
10791810|NCT03353922|FG000|Participant Flow|ABC (Tolperisone, Cyclobenzaprine, Placebo)|1st intervention: 150 mg tolperisone tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: 10 mg cyclobenzaprine every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: placebo every 8 hours for 3 days, followed by release from clinic.
10791811|NCT03353922|FG001|Participant Flow|ACB (Tolperisone, Placebo, Cyclobenzaprine)|1st intervention: 150 mg tolperisone tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: placebo every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: 10 mg cyclobenzaprine every 8 hours for 3 days, followed by release from clinic.
10791812|NCT03353922|FG002|Participant Flow|BAC (Cyclobenzaprine, Tolperisone, Placebo)|1st intervention: 10 mg cyclobenzaprine tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: 150 mg tolperisone cyclobenzaprine every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: placebo every 8 hours for 3 days, followed by release from clinic.
10791813|NCT03353922|FG003|Participant Flow|BCA (Cyclobenzaprine, Placebo, Tolperisone)|1st intervention: 10 mg cyclobenzaprine tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: placebo every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: 150 mg tolperisone every 8 hours for 3 days, followed by release from clinic.
10791814|NCT03353922|FG004|Participant Flow|CAB (Placebo, Tolperisone, Cyclobenzaprine)|1st intervention: placebo tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: 150 mg tolperisone every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: 10 mg cyclobenzaprine every 8 hours for 3 days, followed by release from clinic.
10791815|NCT03353922|FG005|Participant Flow|CBA (Placebo, Cyclobenzaprine, Tolperisone)|1st intervention: placebo tablets administered every 8 hours for 3 days, followed by washout period of 4 days, then 2nd intervention: 10 mg cyclobenzaprine every 8 hours for 3 days, followed by 4 day washout, then 3rd intervention: 150 mg tolperisone every 8 hours for 3 days, followed by release from clinic.
10791816|NCT03353922|OG000|Outcome|Tolperisone HCl 150 mg|150 mg tolperisone tablets administered by mouth every 8 hours for 3 days
10791817|NCT03353922|OG001|Outcome|Placebo Oral Tablet|sugar pills administered by mouth every 8 hours for 3 days
10791818|NCT03353922|OG002|Outcome|Cyclobenzaprine 10 mg Oral Tablet|10 mg cyclobenzapine tablets administered by mouth every 8 hours for 3 days
10791819|NCT03353922|OG000|Outcome|Tolperisone HCl 150 mg|"150 mg tolperisone tablets or cyclobenzaprine 10 mg oral tablet administered by mouth every 8 hours for 3 days~Cyclobenzaprine 10 Mg Oral Tablet: cyclobenzaprine 10 mg tablets~Placebo Oral Tablet: sugar pill"
11195400|NCT02158494|FG001|Participant Flow|Control (Non-zero, Minimally Perceivable Stimulation)|Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).
11339989|NCT03643575|EG001|Reported Event|Treatment B|Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791820|NCT03353922|OG001|Outcome|Placebo Oral Tablet|"sugar pills administered by mouth every 8 hours for 3 days~Cyclobenzaprine 10 Mg Oral Tablet: cyclobenzaprine 10 mg tablets~Placebo Oral Tablet: sugar pill"
10791821|NCT03353922|OG002|Outcome|Cyclobenzaprine 10 mg Oral Tablet|"10 mg cyclobenzapine tablets administered by mouth every 8 hours for 3 days~Placebo Oral Tablet: sugar pill"
10791822|NCT03353922|EG000|Reported Event|Tolperisone HCl 150 mg|150 mg tolperisone tablets administered by mouth every 8 hours for 3 days
10791823|NCT03353922|EG001|Reported Event|Placebo Oral Tablet|sugar pills administered by mouth every 8 hours for 3 days
10791824|NCT03353922|EG002|Reported Event|Cyclobenzaprine 10 mg Oral Tablet|10 mg cyclobenzapine tablets administered by mouth every 8 hours for 3 days
10791825|NCT03322384|BG000|Baseline|Experimental|"All patients will begin epacadostat on day 1 of radiotherapy, which will consist of three threatments over one week. Epacadostat will continue until disease progression or intolerance occurs. On days 1, 8, 15, 22, 29, intralesional injectinons of SD101 will be given to patients.~epacadostat: Epacadostat will be administered orally, in pill form, twice daily until disease progression.~SD-101: Four milligrams of SD-101 will be delivered into the treatment lesion by intralesional injection on days 1, 8, 15, 22, and 29.~Radiotherapy: Radiotherapy will be delivered to the treatment lesion during the first week of ERS therapy."
10791826|NCT03322384|FG000|Participant Flow|Experimental|"All patients will begin epacadostat on day 1 of radiotherapy, which will consist of three threatments over one week. Epacadostat will continue until disease progression or intolerance occurs. On days 1, 8, 15, 22, 29, intralesional injectinons of SD101 will be given to patients.~epacadostat: Epacadostat will be administered orally, in pill form, twice daily until disease progression.~SD-101: Four milligrams of SD-101 will be delivered into the treatment lesion by intralesional injection on days 1, 8, 15, 22, and 29.~Radiotherapy: Radiotherapy will be delivered to the treatment lesion during the first week of ERS therapy."
10791827|NCT03322384|OG000|Outcome|Experimental|"All patients will begin epacadostat on day 1 of radiotherapy, which will consist of three threatments over one week. Epacadostat will continue until disease progression or intolerance occurs. On days 1, 8, 15, 22, 29, intralesional injectinons of SD101 will be given to patients.~epacadostat: Epacadostat will be administered orally, in pill form, twice daily until disease progression.~SD-101: Four milligrams of SD-101 will be delivered into the treatment lesion by intralesional injection on days 1, 8, 15, 22, and 29.~Radiotherapy: Radiotherapy will be delivered to the treatment lesion during the first week of ERS therapy."
10791828|NCT03322384|EG000|Reported Event|Experimental|"All patients will begin epacadostat on day 1 of radiotherapy, which will consist of three threatments over one week. Epacadostat will continue until disease progression or intolerance occurs. On days 1, 8, 15, 22, 29, intralesional injectinons of SD101 will be given to patients.~epacadostat: Epacadostat will be administered orally, in pill form, twice daily until disease progression.~SD-101: Four milligrams of SD-101 will be delivered into the treatment lesion by intralesional injection on days 1, 8, 15, 22, and 29.~Radiotherapy: Radiotherapy will be delivered to the treatment lesion during the first week of ERS therapy."
10791829|NCT03243071|BG000|Baseline|Intervention Group|"The intervention group (n=50) will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
11195401|NCT02158494|OG000|Outcome|Neurostimulation|This randomized double blind controlled study will enroll a total of 44 subjects (M & F) in 2 equal subgroups: 22 with an Active PoNS™, and 22 with a Control (non-zero, minimally perceivable stimulation) device. Subjects will participate in a 3-phase intervention beginning with a 2-week in-lab training program (ITP) (2 in-lab training sessions and 1 home training session daily), followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Subjects will return to the clinic weekly during the at-home phase for a single session of retraining and progression, and participate in periodic retesting.
10791830|NCT03243071|BG001|Baseline|Control Group|"Participants in the control group (n=50) will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791831|NCT03243071|BG002|Baseline|Total|Total of all reporting groups
10791832|NCT03243071|FG000|Participant Flow|Intervention Group|"The intervention group will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
10791833|NCT03243071|FG001|Participant Flow|Control Group|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
11339990|NCT03643575|EG002|Reported Event|Treatment C|Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
10791834|NCT03243071|OG000|Outcome|Intervention Group (Pair 1)|"The intervention group will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
10791835|NCT03243071|OG001|Outcome|Intervention Group (Pair 2)|"The intervention group will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
10791836|NCT03243071|OG002|Outcome|Control Group (Pair 3)|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791837|NCT03243071|OG003|Outcome|Control Group (Pair 4)|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791838|NCT03243071|OG001|Outcome|Control Group (Pair 3)|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791839|NCT03243071|OG000|Outcome|Intervention Group (Pair 2)|"The intervention group will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
10791840|NCT03243071|OG001|Outcome|Control Group (Pair 4)|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791841|NCT03243071|OG002|Outcome|Control Group (Pair 3)|"Participants in the control group (n=50) will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
10791842|NCT03243071|EG000|Reported Event|Intervention Group|"The intervention group will have access to culturally tailored website.~Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website."
10791843|NCT03243071|EG001|Reported Event|Control Group|"Participants in the control group will have access to NYU 's standard trial participation website.~Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment)."
11338984|NCT03621787|FG000|Participant Flow|Single Arm Study: Implant Insertion|"Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire will assess bruising and infection risk. A final visit will assess bruising and infection risk by a physician.~Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately."
10791844|NCT03173456|BG000|Baseline|Oxycodone/APAP|"5 mg oxycodone + 325 mg acetaminophen~oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet"
10791845|NCT03173456|BG001|Baseline|Hydrocodone/APAP|"5 mg hydrocodone + 300 mg acetaminophen~hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet"
10791846|NCT03173456|BG002|Baseline|Codeine/APAP|"30 mg codeine + 300 mg acetaminophen~codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet"
10791847|NCT03173456|BG003|Baseline|400 Ibuprofen/APAP|"400 mg ibuprofen + 1000 mg acetaminophen~400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet"
10791848|NCT03173456|BG004|Baseline|800 Ibuprofen/APAP|"800 mg ibuprofen + 1000 mg acetaminophen~800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet"
10791849|NCT03173456|BG005|Baseline|Total|Total of all reporting groups
10791850|NCT03173456|FG000|Participant Flow|Oxycodone/Acetaminophen (APAP)|"5 mg oxycodone + 325 mg acetaminophen~oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet"
10791851|NCT03173456|FG001|Participant Flow|Hydrocodone/APAP|"5 mg hydrocodone + 300 mg acetaminophen~hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet"
10791852|NCT03173456|FG002|Participant Flow|Codeine/APAP|"30 mg codeine + 300 mg acetaminophen~codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet"
10791853|NCT03173456|FG003|Participant Flow|400 Ibuprofen/APAP|"400 mg ibuprofen + 1000 mg acetaminophen~400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet"
10791854|NCT03173456|FG004|Participant Flow|800 Ibuprofen/APAP|"800 mg ibuprofen + 1000 mg acetaminophen~800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet"
10791855|NCT03173456|OG000|Outcome|400 Ibuprofen/APAP|"400 mg ibuprofen + 1000 mg acetaminophen~400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet"
10791856|NCT03173456|OG001|Outcome|800 Ibuprofen/APAP|"800 mg ibuprofen + 1000 mg acetaminophen~800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet"
10791857|NCT03173456|OG002|Outcome|Codeine/APAP|"30 mg codeine + 300 mg acetaminophen~codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet"
10791858|NCT03173456|OG003|Outcome|Hydrocodone/APAP|"5 mg hydrocodone + 300 mg acetaminophen~hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet"
10791859|NCT03173456|OG004|Outcome|Oxycodone/APAP|"5 mg oxycodone + 325 mg acetaminophen~oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet"
10791860|NCT03173456|EG000|Reported Event|400 Ibuprofen/APAP|"400 mg ibuprofen + 1000 mg acetaminophen~400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet"
10791861|NCT03173456|EG001|Reported Event|800 Ibuprofen/APAP|"800 mg ibuprofen + 1000 mg acetaminophen~800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet"
10791862|NCT03173456|EG002|Reported Event|Codeine/APAP|"30 mg codeine + 300 mg acetaminophen~codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet"
10791863|NCT03173456|EG003|Reported Event|Hydrocodone/APAP|"5 mg hydrocodone + 300 mg acetaminophen~hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet"
10791864|NCT03173456|EG004|Reported Event|Oxycodone/APAP|"5 mg oxycodone + 325 mg acetaminophen~oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet"
10802623|NCT02605993|EG000|Reported Event|Cohort 1|"During the Treatment Period, participants were administered ravulizumab 1400 mg on Day 1, ravulizumab 1000 mg on Day 15 and Day 29, and then ravulizumab 1000 mg every 4 weeks for 7 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802624|NCT02605993|EG001|Reported Event|Cohort 2|"During the Treatment Period, participants were administered ravulizumab 2000 mg on Day 1, ravulizumab 1600 mg on Day 22 and Day 43, and then ravulizumab 1600 mg every 6 weeks for 4 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802625|NCT02605993|EG002|Reported Event|Cohort 3|"During the Treatment Period, participants were administered ravulizumab 1600 mg on Day 1 and Day 15, ravulizumab 2400 mg on Day 29, and then ravulizumab 2400 mg every 8 weeks for 3 doses.~In the Extension Period, participants initially continued to receive their dose. During the second year of the study, participants were administered weight-based doses of ravulizumab every 8 weeks for up to 5 years: 3000 mg for participants weighing 40 to less than 60 kg, 3300 mg for participants weighing 60 to less than 100 kg, and 3600 mg for participants weighing 100 kg or more."
10802626|NCT02605993|EG003|Reported Event|Cohort 4|"During the Treatment Period, participants were administered ravulizumab 3000 mg on Day 1, ravulizumab 5400 mg on Day 29, and then ravulizumab 5400 mg every 12 weeks for 2 doses.~During the Extension Period, participants were administered ravulizumab 5400 mg every 12 weeks for up to 5 years."
10802627|NCT02522715|BG000|Baseline|Phase I - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10802628|NCT02522715|BG001|Baseline|Phase II - Treatment (Cabazitaxel, Enzalutamide)|Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.
10802629|NCT02522715|BG002|Baseline|Total|Total of all reporting groups
10802630|NCT02522715|FG000|Participant Flow|Phase I - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10802631|NCT02522715|FG001|Participant Flow|Phase II - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10802632|NCT02522715|OG000|Outcome|Phase I - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10802633|NCT02522715|OG000|Outcome|Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10850921|NCT03651622|BG002|Baseline|Mediterranean, no Caloric Restriction|Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
11195402|NCT02158494|OG001|Outcome|Control (Non-zero, Minimally Perceivable Stimulation)|This randomized double blind controlled study will enroll a total of 44 subjects (M & F) in 2 equal subgroups: 22 with an Active PoNS™, and 22 with a Control (non-zero, minimally perceivable stimulation) device. Subjects will participate in a 3-phase intervention beginning with a 2-week in-lab training program (ITP) (2 in-lab training sessions and 1 home training session daily), followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Subjects will return to the clinic weekly during the at-home phase for a single session of retraining and progression, and participate in periodic retesting.
11195403|NCT02158494|OG000|Outcome|Neurostimulation|"Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).~Balance and Gait Training using neurostimulation modulation.: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
11195404|NCT02158494|OG001|Outcome|Minimally Perceivable Stimulation|"Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).~Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
10791865|NCT03101566|BG000|Baseline|Gemcitabine + Cisplatin + Nivolumab|Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.
10791866|NCT03101566|BG001|Baseline|Nivolumab + Ipilimumab|Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
10791867|NCT03101566|BG002|Baseline|Total|Total of all reporting groups
10791868|NCT03101566|FG000|Participant Flow|Gemcitabine + Cisplatin + Nivolumab|Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.
10791869|NCT03101566|FG001|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
10791870|NCT03101566|OG000|Outcome|Gemcitabine + Cisplatin + Nivolumab|Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.
10791871|NCT03101566|OG001|Outcome|Nivolumab + Ipilimumab|Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
10791872|NCT03101566|EG000|Reported Event|Gemcitabine + Cisplatin + Nivolumab|Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.
10791873|NCT03101566|EG001|Reported Event|Nivolumab + Ipilimumab|Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
10791874|NCT03003520|BG000|Baseline|DUR + R-CHOP|On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP (IV rituximab 375 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2; and daily oral or IV prednisone/prednisolone 100 mg on Days 1 to 5. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.
10791875|NCT03003520|BG001|Baseline|DUR + R2-CHOP|"Participants start the study on durvalumab in combination with R-CHOP (as described in Arm DUR + R-CHOP). Based on their DLBCL Cell-of-Origin subtype (test typically done between cycles 1 and 2), participants with ABC subtype continue the study taking durvalumab in combination with R2-CHOP. On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg IV followed by R-CHOP. In addition, participants receive oral lenalidomide 15 mg by mouth on Days 1 to 14 of each 21-day cycle. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.~Enrollment into Arm B was discontinued."
10791876|NCT03003520|BG002|Baseline|Total|Total of all reporting groups
10791877|NCT03003520|FG000|Participant Flow|DUR + R-CHOP|On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP (IV rituximab 375 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2; and daily oral or IV prednisone/prednisolone 100 mg on Days 1 to 5. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.
10802634|NCT02522715|EG000|Reported Event|Phase I - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10791878|NCT03003520|FG001|Participant Flow|DUR + R2-CHOP|"Participants start the study on durvalumab in combination with R-CHOP (as described in Arm DUR + R-CHOP). Based on their DLBCL Cell-of-Origin subtype (test typically done between cycles 1 and 2), participants with ABC subtype continue the study taking durvalumab in combination with R2-CHOP. On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg IV followed by R-CHOP. In addition, participants receive oral lenalidomide 15 mg by mouth on Days 1 to 14 of each 21-day cycle. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.~Enrollment into Arm B was discontinued."
10791879|NCT03003520|OG000|Outcome|DUR + R-CHOP|On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP (IV rituximab 375 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2; and daily oral or IV prednisone/prednisolone 100 mg on Days 1 to 5. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.
10791880|NCT03003520|OG001|Outcome|DUR + R2-CHOP|"Participants start the study on durvalumab in combination with R-CHOP (as described in Arm DUR + R-CHOP). Based on their DLBCL Cell-of-Origin subtype (test typically done between cycles 1 and 2), participants with ABC subtype continue the study taking durvalumab in combination with R2-CHOP. On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg IV followed by R-CHOP. In addition, participants receive oral lenalidomide 15 mg by mouth on Days 1 to 14 of each 21-day cycle. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.~Enrollment into Arm B was discontinued."
10791881|NCT03003520|OG000|Outcome|High Group for CD8 Density|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their CD8 density evaluation was above threshold,defined as the median of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods. Participants with values above threshold were predicted to be responders.
10791882|NCT03003520|OG001|Outcome|Low Group for CD8 Density|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their CD8 density evaluation was below threshold,defined as the median of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods. Participants with values below threshold were predicted to be non-responders.
10791883|NCT03003520|OG000|Outcome|High Group for PDL1 % of Total Cells|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their PDL1 % of total cell evaluation was above threshold,defined as the median of 13.8% found in commercial DLBCL samples using matched analytical methods. Participants with values above threshold were predicted to be responders.
10791884|NCT03003520|OG001|Outcome|Low Group for PDL1 % of Total Cells|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their PDL1 % of total cell evaluation was below threshold,defined as the median of 13.8% found in commercial DLBCL samples using matched analytical methods. Participants with values below threshold were predicted to be non-responders.
10791885|NCT03003520|OG000|Outcome|High Group for PDL1 % of Tumor Cells|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their PD-1 % of tumor cell evaluation was above threshold,defined as the median of 6.2% found in commercial DLBCL samples using matched analytical methods. Participants with values above threshold were predicted to be responders.
10791886|NCT03003520|OG001|Outcome|Low Group for PDL1 % of Tumor Cells|Participants had IHC analysis performed on a biopsy sample collected before treatment on this protocol. The result of their PDL1 % of tumor cell evaluation was below threshold,defined as the median of 6.2% found in commercial DLBCL samples using matched analytical methods. Participants with values below threshold were predicted to be non-responders.
10791887|NCT03003520|OG000|Outcome|High Group for RNA IFN Gamma Score|Participants had RNA IFN Gamma Score calculated based on a biopsy sample collected before treatment on this protocol. The result of their RNA IFN Gamma Score was above threshold,defined as the median of 3.28 found in commercial DLBCL samples using matched analytical methods. Participants with values above threshold were predicted to be responders.
10791888|NCT03003520|OG001|Outcome|Low Group for RNA IFN Gamma Score|Participants had RNA IFN Gamma Score calculated based on a biopsy sample collected before treatment on this protocol. The result of their RNA IFN Gamma Score was below threshold,defined as the median of 3.28 found in commercial DLBCL samples using matched analytical methods. Participants with values below threshold were predicted to be non-responders.
10791889|NCT03003520|EG000|Reported Event|DUR + R-CHOP|On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg intravenously (IV) followed by R-CHOP (IV rituximab 375 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2; and daily oral or IV prednisone/prednisolone 100 mg on Days 1 to 5. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.
10791890|NCT03003520|EG001|Reported Event|DUR + R2-CHOP|"Participants start the study on durvalumab in combination with R-CHOP (as described in Arm DUR + R-CHOP). Based on their DLBCL Cell-of-Origin subtype (test typically done between cycles 1 and 2), participants with ABC subtype continue the study taking durvalumab in combination with R2-CHOP. On Day 1 of each 21-day cycle, participants received durvalumab 1125 mg IV followed by R-CHOP. In addition, participants receive oral lenalidomide 15 mg by mouth on Days 1 to 14 of each 21-day cycle. Induction treatment continued for a total of 6-8 cycles. Participants who achieve a complete response or partial response continue with consolidation therapy treatment and receive durvalumab monotherapy 1500 mg by IV on Day 1 of each 28-day cycle for up to a total of 12 months.~Enrollment into Arm B was discontinued."
10791891|NCT02862457|BG000|Baseline|Part A Cohort 1: Epacadostat 25 mg|Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791892|NCT02862457|BG001|Baseline|Part A Cohort 1: Epacadostat 100 mg|Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791893|NCT02862457|BG002|Baseline|Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791894|NCT02862457|BG003|Baseline|Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791895|NCT02862457|BG004|Baseline|Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791896|NCT02862457|BG005|Baseline|Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791897|NCT02862457|BG006|Baseline|Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791898|NCT02862457|BG007|Baseline|Total|Total of all reporting groups
10791899|NCT02862457|FG000|Participant Flow|Part A Cohort 1: Epacadostat 25 mg|Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
11195405|NCT02158494|OG000|Outcome|Neurostimulation|"Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).~Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
10791900|NCT02862457|FG001|Participant Flow|Part A Cohort 1: Epacadostat 100 mg|Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791901|NCT02862457|FG002|Participant Flow|Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791902|NCT02862457|FG003|Participant Flow|Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10850922|NCT03651622|BG003|Baseline|Total|Total of all reporting groups
11195406|NCT02158494|OG000|Outcome|Neurostimulation|Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training)
11195407|NCT02158494|OG001|Outcome|Control (Non-zero, Minimally Perceivable Stimulation)|Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).
11195408|NCT02158494|EG000|Reported Event|Neurostimulation|"Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).~Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
10791903|NCT02862457|FG004|Participant Flow|Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791904|NCT02862457|FG005|Participant Flow|Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791905|NCT02862457|FG006|Participant Flow|Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791906|NCT02862457|OG000|Outcome|Part A Cohort 1: Epacadostat 25 mg|Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791907|NCT02862457|OG001|Outcome|Part A Cohort 1: Epacadostat 100 mg|Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791908|NCT02862457|OG002|Outcome|Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791909|NCT02862457|OG003|Outcome|Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791910|NCT02862457|OG004|Outcome|Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791911|NCT02862457|OG005|Outcome|Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791912|NCT02862457|OG006|Outcome|Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791913|NCT02862457|OG000|Outcome|Part A Combined Cohort 1|All participants who received either dose (25 or 100 mg) of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat BID on Days 1-21.
10791914|NCT02862457|OG001|Outcome|Part A Combined Cohort 2|All participants who received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat orally BID on Days 1-21 for each 21-day cycle.
10791915|NCT02862457|OG002|Outcome|Part A Combined Cohorts 1 and 2|All participants in Cohorts 1 and 2 combined.
11195409|NCT02158494|EG001|Reported Event|Minimally Perceivable Stimulation|"Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training).~Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
10791916|NCT02862457|OG000|Outcome|Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791917|NCT02862457|OG001|Outcome|Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791918|NCT02862457|OG002|Outcome|Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791919|NCT02862457|OG003|Outcome|Part B Combined Cohorts 1, 2, and 3|All participants in Cohorts 1, 2, and 3 combined.
10791920|NCT02862457|OG002|Outcome|Part A Combined Cohorts 1 And 2|All participants in Cohorts 1 and 2 combined.
10791921|NCT02862457|EG000|Reported Event|Part A Cohort 1: Epacadostat 25 mg|Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791922|NCT02862457|EG001|Reported Event|Part A Cohort 1: Epacadostat 100 mg|Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791923|NCT02862457|EG002|Reported Event|Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791924|NCT02862457|EG003|Reported Event|Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
10791925|NCT02862457|EG004|Reported Event|Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791926|NCT02862457|EG005|Reported Event|Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791927|NCT02862457|EG006|Reported Event|Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel|For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
10791928|NCT02820753|BG000|Baseline|Enhanced Usual Care|"Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care.~Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles)."
10791929|NCT02820753|BG001|Baseline|Text or Portal|"Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.~EHR + (Text or Portal): Per protocol analysis:~Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey."
10791930|NCT02820753|BG002|Baseline|Total|Total of all reporting groups
10791931|NCT02820753|FG000|Participant Flow|Enhanced Usual Care|"Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care.~Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles)."
10791932|NCT02820753|FG001|Participant Flow|Text or Portal|"Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.~EHR + (Text or Portal): Per protocol analysis:~Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey."
10791933|NCT02820753|OG000|Outcome|Enhanced Usual Care|"Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care.~Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles)."
10791934|NCT02820753|OG001|Outcome|Text or Portal|"Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.~EHR + (Text or Portal): Per protocol analysis:~Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey."
10791935|NCT02820753|EG000|Reported Event|Enhanced Usual Care|"Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care.~Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles)."
10791936|NCT02820753|EG001|Reported Event|Text or Portal|"Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.~EHR + (Text or Portal): Per protocol analysis:~Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey."
10791937|NCT02733042|BG000|Baseline|Part 1, Arm A: DUR 1500 mg + LEN 20 mg|Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
10791938|NCT02733042|BG001|Baseline|Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791939|NCT02733042|BG002|Baseline|Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791940|NCT02733042|BG003|Baseline|Part 1, Arm B: DUR 1500 mg + IBR 420 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791941|NCT02733042|BG004|Baseline|Part 1, Arm B: DUR 1500 mg + IBR 560 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791942|NCT02733042|BG005|Baseline|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791943|NCT02733042|BG006|Baseline|Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.
10791944|NCT02733042|BG007|Baseline|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791945|NCT02733042|BG008|Baseline|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/mÂ² + BEN 90 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791946|NCT02733042|BG009|Baseline|Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mG|Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791947|NCT02733042|BG010|Baseline|Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791948|NCT02733042|BG011|Baseline|Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791949|NCT02733042|BG012|Baseline|Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791950|NCT02733042|BG013|Baseline|Part 2, Arm C CLL/SLL: DUR + RIT 375 mg/m² + BEN 70 mg/m²|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791951|NCT02733042|BG014|Baseline|Part 2, Arm D FL: DUR 1500 mg|Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791952|NCT02733042|BG015|Baseline|Part 2, Arm D DLBCL: DUR 1500 mg|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
11195410|NCT02158520|BG000|Baseline|Arm A (Bevacizumab and Nab-paclitaxel)|Patients receive bevacizumab 10mg/kg IV over 30-90 minutes on days 1 and 15 and nab-paclitaxel 150 mg/m^2 IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm B within 2-4 weeks.
10791953|NCT02733042|BG016|Baseline|Part 2, Arm D CLL/SLL: DUR 1500 mg|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791954|NCT02733042|BG017|Baseline|Part 2, Arm D MCL: DUR 1500 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791955|NCT02733042|BG018|Baseline|Part 2 Arm D HL: DUR 1500 mg|Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791956|NCT02733042|BG019|Baseline|Total|Total of all reporting groups
10791957|NCT02733042|FG000|Participant Flow|Part 1, Arm A: DUR 1500 mg + LEN 20 mg|Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
10791958|NCT02733042|FG001|Participant Flow|Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791959|NCT02733042|FG002|Participant Flow|Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791960|NCT02733042|FG003|Participant Flow|Part 1, Arm B: DUR 1500 mg + IBR 420 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib (IBR) 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791961|NCT02733042|FG004|Participant Flow|Part 1, Arm B: DUR 1500 mg + IBR 560 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791962|NCT02733042|FG005|Participant Flow|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791963|NCT02733042|FG006|Participant Flow|Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine (BEN) 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.
10791964|NCT02733042|FG007|Participant Flow|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791965|NCT02733042|FG008|Participant Flow|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791966|NCT02733042|FG009|Participant Flow|Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg|Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791967|NCT02733042|FG010|Participant Flow|Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791968|NCT02733042|FG011|Participant Flow|Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791969|NCT02733042|FG012|Participant Flow|Part 2 Arm C DLBCL: DUR mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791970|NCT02733042|FG013|Participant Flow|Part 2, Arm C CLL/SLL: DUR + RIT 375 mg/m² + BEN 70 mg/m²|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791971|NCT02733042|FG014|Participant Flow|Part 2, Arm D FL: DUR 1500 mg|Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791972|NCT02733042|FG015|Participant Flow|Part 2, Arm D DLBCL: DUR 1500 mg|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791973|NCT02733042|FG016|Participant Flow|Part 2, Arm D CLL/SLL: DUR 1500 mg|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791974|NCT02733042|FG017|Participant Flow|Part 2, Arm D MCL: DUR 1500 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791975|NCT02733042|FG018|Participant Flow|Part 2 Arm D HL: DUR 1500 mg|Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791976|NCT02733042|OG000|Outcome|Part 1, Arm A: DUR 1500 mg + LEN 20 mg|Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
10791977|NCT02733042|OG001|Outcome|Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791978|NCT02733042|OG002|Outcome|Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10791979|NCT02733042|OG003|Outcome|Part 1, Arm B: DUR 1500 mg + IBR 420 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791980|NCT02733042|OG004|Outcome|Part 1, Arm B: DUR 1500 mg + IBR 560 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791981|NCT02733042|OG005|Outcome|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791982|NCT02733042|OG006|Outcome|Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.
10791983|NCT02733042|OG007|Outcome|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791984|NCT02733042|OG008|Outcome|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791985|NCT02733042|OG009|Outcome|Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg|Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
11195411|NCT02158520|BG001|Baseline|Arm B (Ipilimumab)|Patients receive ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm A within 2-4 weeks.
11195412|NCT02158520|BG002|Baseline|Total|Total of all reporting groups
11195413|NCT02158520|FG000|Participant Flow|Arm A (Bevacizumab and Nab-paclitaxel)|Patients receive bevacizumab 10mg/kg IV over 30-90 minutes on days 1 and 15 and nab-paclitaxel 150 mg/m^2 IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm B within 2-4 weeks.
10791986|NCT02733042|OG010|Outcome|Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791987|NCT02733042|OG011|Outcome|Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791988|NCT02733042|OG012|Outcome|Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791989|NCT02733042|OG013|Outcome|Part 2, Arm C CLL/SLL: DUR + RIT 375 mg/m² + BEN 70 mg/m²|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791990|NCT02733042|OG014|Outcome|Part 2, Arm D FL: DUR 1500 mg|Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791991|NCT02733042|OG015|Outcome|Part 2, Arm D DLBCL: DUR 1500 mg|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791992|NCT02733042|OG016|Outcome|Part 2, Arm D CLL/SLL: DUR 1500 mg|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791993|NCT02733042|OG017|Outcome|Part 2, Arm D MCL: DUR 1500 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791994|NCT02733042|OG018|Outcome|Part 2 Arm D HL: DUR 1500 mg|Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10791995|NCT02733042|OG012|Outcome|Part 2 Arm C DLBCL: DUR + RIT 375 mg/m² + BEN 70 mg/m²|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10791996|NCT02733042|OG000|Outcome|Arm A: Durvalumab + Lenalidomide ± Rituximab|Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
10791997|NCT02733042|OG001|Outcome|Arm B: Durvalumab + Ibrutinib|Participants assigned to Arm B received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 420 or 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10791998|NCT02733042|OG002|Outcome|Arm C: Durvalumab + Bendamustine ± Rituximab|Participants assigned to Arm C received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, 70 or 90 mg/m² bendamustine IV on Days 1 and 2 of Cycles 1 to 6, and rituximab 375 mg/m² IV on Day 2 of Cycles 1 to 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10791999|NCT02733042|OG003|Outcome|Arm D: Durvalumab Monotherapy|Participants assigned to Arm D received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13.
10792000|NCT02733042|OG000|Outcome|Arm A: Durvalumab + Lenalidomide Â± Rituximab|Participants assigned to Arm A received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and 10 mg or 20 mg lenalidomide orally once daily on Days 1 to 21 of Cycles 1 to 13 in indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
10792001|NCT02733042|OG000|Outcome|Arm A: Lenalidomide 10 mg|Participants in Arm A received lenalidomide 10 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
10792002|NCT02733042|OG001|Outcome|Arm A: Lenalidomide 20 mg|Participants in Arm A received lenalidomide 20 mg orally once daily on Days 1 to 21 of Cycles 1 to 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 to 13, and rituximab 375 mg/m² IV weekly in Cycle 1 and on Day 1 of Cycles 2 to 5.
10792003|NCT02733042|OG000|Outcome|Arm B: Ibrutinib 420 mg|Participants assigned to Arm B received 420 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.
10792004|NCT02733042|OG001|Outcome|Arm B: Ibrutinib 560 mg|Participants assigned to Arm B received 560 mg ibrutinib orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason, and durvalumab 1500 mg IV on Day 1 of Cycles 1 to 13.
10792005|NCT02733042|EG000|Reported Event|Part 1, Arm A: DUR 1500 mg + LEN 20 mg|Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.
10792006|NCT02733042|EG001|Reported Event|Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10792007|NCT02733042|EG002|Reported Event|Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²|Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.
10792008|NCT02733042|EG003|Reported Event|Part 1, Arm B: DUR 1500 mg + IBR 420 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib orally 420 mg once daily until disease progression, unacceptable toxicity or discontinuation for any other reason
10792009|NCT02733042|EG004|Reported Event|Part 1, Arm B: DUR 1500 mg + IBR 560 mg|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib orally 560 mg once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10792010|NCT02733042|EG005|Reported Event|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10792011|NCT02733042|EG006|Reported Event|Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.
10792012|NCT02733042|EG007|Reported Event|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10792013|NCT02733042|EG008|Reported Event|Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²|Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10792014|NCT02733042|EG009|Reported Event|Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg|Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10792015|NCT02733042|EG010|Reported Event|Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.
10792016|NCT02733042|EG011|Reported Event|Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10792017|NCT02733042|EG012|Reported Event|Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.
10792018|NCT02733042|EG013|Reported Event|Part 2, Arm C CLL/SLL: DUR + RIT 375 mg/m² + BEN 70 mg/m²|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).
10792019|NCT02733042|EG014|Reported Event|Part 2, Arm D FL: DUR 1500 mg|Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10792020|NCT02733042|EG015|Reported Event|Part 2, Arm D DLBCL: DUR 1500 mg|Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10792021|NCT02733042|EG016|Reported Event|Part 2, Arm D CLL/SLL: DUR 1500 mg|Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10792022|NCT02733042|EG017|Reported Event|Part 2, Arm D MCL: DUR 1500 mg|Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10792023|NCT02733042|EG018|Reported Event|Part 2, Arm D hL: DUR 1500 mg|Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.
10792024|NCT02668874|BG000|Baseline|Overall Group|"The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants.~Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application."
10792025|NCT02668874|FG000|Participant Flow|Isolite System|The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.
10792026|NCT02668874|FG001|Participant Flow|Cotton Roll System|A cotton roll is placed between the cheek and tongue prior to sealant placement.
10792027|NCT02668874|OG000|Outcome|Isolite® Technique Device|"The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants.~Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application."
10792028|NCT02668874|OG001|Outcome|Cotton Roll Technique Device|"The resident dentist with whom the child is scheduled with apply the sealants after the cotton roll technique has been placed.~Cotton Roll technique: A cotton roll is placed between the cheek and tongue prior to sealant application"
11195414|NCT02158520|FG001|Participant Flow|Arm B (Ipilimumab)|Patients receive ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm A within 2-4 weeks.
10792029|NCT02668874|EG000|Reported Event|Isolite® Technique Device|"The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants.~Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application."
10792030|NCT02668874|EG001|Reported Event|Cotton Roll Technique Device|"The resident dentist with whom the child is scheduled with apply the sealants after the cotton roll technique has been placed.~Cotton Roll technique: A cotton roll is placed between the cheek and tongue prior to sealant application"
10792031|NCT02609737|BG000|Baseline|68Ga-DOTA-JR11 and 177Lu-DOTA-JR11|Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging & therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
10849948|NCT00299182|EG003|Reported Event|Placebo (Arm A & Arm B) With Chemotherapy|"Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy~Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10792032|NCT02609737|FG000|Participant Flow|68Ga-DOTA-JR11 and 177Lu-DOTA-JR11|Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging & therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
10792033|NCT02609737|OG000|Outcome|68Ga-DOTA-JR11 and 177Lu-DOTA-JR11|Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging & therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
10792034|NCT02609737|EG000|Reported Event|68Ga-DOTA-JR11 and 177Lu-DOTA-JR11|Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging & therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
10792035|NCT02574286|BG000|Baseline|Velaglucerase Alfa 60 U/kg|Participants received 60-minute intravenous (IV) infusion of 60 units per kilogram (U/kg) velaglucerase alfa EOW for 24 months (up to 101 weeks).
10792036|NCT02574286|FG000|Participant Flow|Velaglucerase Alfa 60 U/kg|Participants received 60-minute intravenous (IV) infusion of 60 units per kilogram (U/kg) velaglucerase alfa every other Week (EOW) for 24 months (up to 101 weeks).
10792037|NCT02574286|OG000|Outcome|Velaglucerase Alfa 60 U/kg|Participants received 60-minute intravenous (IV) infusion of 60 units per kilogram (U/kg) velaglucerase alfa every other Week (EOW) for 24 months (up to 101 weeks).
10792038|NCT02574286|EG000|Reported Event|Velaglucerase Alfa 60 U/kg|Subjects received 60-minute intravenous (IV) infusion of 60 units per kilogram (U/kg) velaglucerase alfa every other Week (EOW) for 24 months (up to 101 weeks).
10792039|NCT02471144|BG000|Baseline|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
10792040|NCT02471144|BG001|Baseline|AIN457 High Dose|Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
10792041|NCT02471144|BG002|Baseline|Placebo|Patients received matching placebo to secukinumab at each dosing
10792042|NCT02471144|BG003|Baseline|Etanercept|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792043|NCT02471144|BG004|Baseline|Total|Total of all reporting groups
10792044|NCT02471144|FG000|Participant Flow|AIN457 Low Dose (Induction Period)|Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
10792045|NCT02471144|FG001|Participant Flow|AIN457 High Dose (Induction Period)|Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
10792046|NCT02471144|FG002|Participant Flow|Placebo (Induction Period)|Patients received matching placebo to secukinumab at each dosing
10792047|NCT02471144|FG003|Participant Flow|Etanercept Comparator (Induction Period)|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792048|NCT02471144|FG004|Participant Flow|AIN457 Low Dose (Maintenance Period)|Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
10792049|NCT02471144|FG005|Participant Flow|AIN457 High Dose (Maintenance Period)|Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
10792050|NCT02471144|FG006|Participant Flow|Placebo-AIN457 Low Dose (Maintenance Period)|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study
10792051|NCT02471144|FG007|Participant Flow|Placebo-AIN457 High Dose (Maintenance Period|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study
10792052|NCT02471144|FG008|Participant Flow|Etanercept Comparator (Maintenance Period)|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792053|NCT02471144|FG009|Participant Flow|Any AIN457 Low Dose (Extension Period)|Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups
10792054|NCT02471144|FG010|Participant Flow|Any AIN457 High Dose (Extension Period)|Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups
10792055|NCT02471144|OG000|Outcome|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
10792056|NCT02471144|OG001|Outcome|AIN457 High Dose|Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
10792057|NCT02471144|OG002|Outcome|Placebo|Patients received matching placebo to secukinumab at each dosing
10792058|NCT02471144|OG003|Outcome|Etanercept|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792059|NCT02471144|OG002|Outcome|Placebo-AIN457 Low Dose|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study
10792060|NCT02471144|OG003|Outcome|Placebo- AIN457 High Dose|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study
10792061|NCT02471144|OG004|Outcome|Etanercept|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792062|NCT02471144|OG003|Outcome|Placebo-AIN457 High Dose|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study
10792063|NCT02471144|OG002|Outcome|Placebo- AIN457 Low Dose|Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study
10792064|NCT02471144|EG000|Reported Event|Any AIN457 Low Dose|Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups
10792065|NCT02471144|EG001|Reported Event|Any AIN457 High Dose|Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups
10792066|NCT02471144|EG002|Reported Event|Any AIN457 Dose|Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups
10792067|NCT02471144|EG003|Reported Event|Placebo|Patients received matching placebo to secukinumab at each dosing
10792068|NCT02471144|EG004|Reported Event|Etanercept|Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
10792069|NCT02440464|BG000|Baseline|Ixazomib Maintenance|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles."
10792070|NCT02440464|BG001|Baseline|Placebo|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles."
10792071|NCT02440464|BG002|Baseline|Total|Total of all reporting groups
10792072|NCT02440464|FG000|Participant Flow|Ixazomib Maintenance|"Allogeneic hematopoietic stem cell transplantation (HSCT) and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For graft-versus-host disease (GVHD) prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles."
10792073|NCT02440464|FG001|Participant Flow|Placebo|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles."
10850932|NCT03410992|BG000|Baseline|Placebo|Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11383133|NCT02584829|OG000|Outcome|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
11383134|NCT02584829|EG000|Reported Event|Group 1 (Avelumab and MHC Class I Up-regulation)|"Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383135|NCT02584829|EG001|Reported Event|Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)|"Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.~Avelumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV~Radiation Therapy: Undergo radiation therapy~Recombinant Interferon Beta: Given via intra-tumor injection"
11383136|NCT02570308|BG000|Baseline|Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383137|NCT02570308|BG001|Baseline|Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383138|NCT02570308|BG002|Baseline|Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383139|NCT02570308|BG003|Baseline|Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383140|NCT02570308|BG004|Baseline|Phase 2 Dose Expansion: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383141|NCT02570308|BG005|Baseline|Total|Total of all reporting groups
11383142|NCT02570308|FG000|Participant Flow|Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383143|NCT02570308|FG001|Participant Flow|Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383144|NCT02570308|FG002|Participant Flow|Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383145|NCT02570308|FG003|Participant Flow|Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383146|NCT02570308|FG004|Participant Flow|Phase 2 Dose Expansion: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383147|NCT02570308|OG000|Outcome|Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383148|NCT02570308|OG001|Outcome|Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383149|NCT02570308|OG002|Outcome|Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383150|NCT02570308|OG003|Outcome|Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383151|NCT02570308|OG000|Outcome|Phase 2 Dose Expansion: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383152|NCT02570308|OG000|Outcome|Phase 1 Dose Escalation|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383153|NCT02570308|OG001|Outcome|Phase 2 Dose Expansion|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
11383154|NCT02570308|OG002|Outcome|Phase 1 Dose Escalation Cohort 2: 73 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383155|NCT02570308|OG003|Outcome|Phase 1 Dose Escalation Cohort 2: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383156|NCT02570308|OG004|Outcome|Phase 2 Dose Expansion|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
11383157|NCT02570308|OG004|Outcome|Phase 2 Dose Expansion: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383158|NCT02570308|EG000|Reported Event|Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383159|NCT02570308|EG001|Reported Event|Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383160|NCT02570308|EG002|Reported Event|Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383161|NCT02570308|EG003|Reported Event|Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383162|NCT02570308|EG004|Reported Event|Phase 2 Dose Expansion: 68 mcg Tebentafusp|Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
11383163|NCT02516241|BG000|Baseline|Combination Therapy|MEDI4736 (Durvalumab) + Tremelimumab
11383164|NCT02516241|BG001|Baseline|Monotherapy|MEDI4736 (Durvalumab)
11383165|NCT02516241|BG002|Baseline|Standard of Care|Standard of Care Chemotherapy Treatment
11383166|NCT02516241|BG003|Baseline|Total|Total of all reporting groups
11383167|NCT02516241|FG000|Participant Flow|Combination Therapy|MEDI4736 (Durvalumab) + Tremelimumab
11383168|NCT02516241|FG001|Participant Flow|Monotherapy|MEDI4736 (Durvalumab)
11383169|NCT02516241|FG002|Participant Flow|Standard of Care|Standard of Care Chemotherapy Treatment
11383170|NCT02516241|OG000|Outcome|Combination Therapy|MEDI4736 (Durvalumab) + Tremelimumab
11383171|NCT02516241|OG001|Outcome|Standard of Care|Standard of Care Chemotherapy Treatment
11383172|NCT02516241|OG000|Outcome|Monotherapy|MEDI4736 (Durvalumab)
11383173|NCT02516241|OG001|Outcome|Monotherapy|MEDI4736 (Durvalumab)
11383174|NCT02516241|OG002|Outcome|Standard of Care|Standard of Care Chemotherapy Treatment
11383175|NCT02516241|OG000|Outcome|Monotherapy - PD-L1 High|MEDI4736 (Durvalumab) - PD-L1 high
11383176|NCT02516241|OG001|Outcome|Monotherapy - PD-L1 Low/Negative|MEDI4736 (Durvalumab) - PD-L1 low/negative
11383177|NCT02516241|OG002|Outcome|Monotherapy - Total|MEDI4736 (Durvalumab)
11383178|NCT02516241|EG000|Reported Event|Combination Therapy|MEDI4736 (Durvalumab) + Tremelimumab
11383179|NCT02516241|EG001|Reported Event|Monotherapy|MEDI4736 (Durvalumab)
11383180|NCT02516241|EG002|Reported Event|Standard of Care|Standard of Care Chemotherapy Treatment
11383181|NCT02514083|BG000|Baseline|Ibrutinib With Fludarabine in Patients With CLL or SLL|Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
11383182|NCT02514083|FG000|Participant Flow|Ibrutinib With Fludarabine in Patients With CLL or SLL|Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
11383183|NCT02514083|OG000|Outcome|Ibrutinib With Fludarabine in Patients With CLL or SLL|Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
11383184|NCT02514083|EG000|Reported Event|Ibrutinib With Fludarabine in Patients With CLL or SLL|Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for days 1-28 from Cycle 1 up to Cycle 27. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
11383185|NCT02497612|BG000|Baseline|Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
10792074|NCT02440464|OG000|Outcome|Ixazomib Maintenance|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles."
10792075|NCT02440464|OG001|Outcome|Placebo|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles."
10792076|NCT02440464|EG000|Reported Event|Ixazomib Maintenance|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles."
10792077|NCT02440464|EG001|Reported Event|Placebo|"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.~Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.~Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.~Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.~Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.~Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles."
10792078|NCT02440464|EG002|Reported Event|Enrolled Not Randomized|Participants who enrolled in the study but were not randomized to treatment.
10792079|NCT02384421|BG000|Baseline|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
10792080|NCT02384421|FG000|Participant Flow|Activa PC+S Neurostimulator|"Participants will be own controls and undergo both Adaptive DBS (Activa PC+S Neurostimulator) and Continuous DBS (Activa PC+S Neurostimulator) deep brain stimulation testing paradigms using Nexus D research tool~PC+S: Primary Cell+Sensing"
10792081|NCT02384421|OG000|Outcome|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
10792082|NCT02384421|OG000|Outcome|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive and Continuous deep brain stimulation. OFF refers to off therapy (i.e. withdrawn medication and no deep brain stimulation). aDBS refers to an adaptive DBS based on a neural controller.
10792083|NCT02384421|OG000|Outcome|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive and Continuous deep brain stimulation. OFF refers to off therapy (i.e. withdrawn medication and no deep brain stimulation). aDBS refers to an adaptive DBS based on a kinematic controller.
10792084|NCT02384421|OG000|Outcome|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive and Continuous deep brain stimulation. cDBS refers to Clinical Open Loop DBS. aDBS refers to an adaptive DBS based on a neural controller.
10792085|NCT02384421|EG000|Reported Event|Activa PC+S Neurostimulator|Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
10792086|NCT02366728|BG000|Baseline|Group I: Unpulsed DC Pre-conditioning|0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792087|NCT02366728|BG001|Baseline|Group II: Tetanus Pre-conditioning|Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792088|NCT02366728|BG002|Baseline|Group III: Basiliximab and Tetanus Pre-conditioning|Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
10792089|NCT02366728|BG003|Baseline|Total|Total of all reporting groups
10792090|NCT02366728|FG000|Participant Flow|Group I: Unpulsed DC Pre-conditioning|0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792091|NCT02366728|FG001|Participant Flow|Group II: Tetanus Pre-conditioning|Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
11195415|NCT02158520|OG000|Outcome|Arm A (Bevacizumab and Nab-paclitaxel)|Patients receive bevacizumab 10mg/kg IV over 30-90 minutes on days 1 and 15 and nab-paclitaxel 150 mg/m^2 IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm B within 2-4 weeks.
10792092|NCT02366728|FG002|Participant Flow|Group III: Basiliximab and Tetanus Pre-conditioning|Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
10792093|NCT02366728|OG000|Outcome|Group I: Unpulsed DC Pre-conditioning|0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792094|NCT02366728|OG001|Outcome|Group II: Tetanus Pre-conditioning|Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792095|NCT02366728|OG002|Outcome|Group III: Basiliximab and Tetanus Pre-conditioning|Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
10792096|NCT02366728|EG000|Reported Event|Group I: Unpulsed DC Pre-conditioning|0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792097|NCT02366728|EG001|Reported Event|Group II: Tetanus Pre-conditioning|Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
10792098|NCT02366728|EG002|Reported Event|Group III: Basiliximab and Tetanus Pre-conditioning|Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
10792099|NCT02236572|BG000|Baseline|Aromatase Inhibitor Plus Everolimus|"Aromatase inhibitor plus everolimus by mouth daily for 26 weeks~Everolimus: Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:~Anastrozole 1 mg~Letrozole 2.5 mg~Exemestane 25 mg"
10792100|NCT02236572|FG000|Participant Flow|Aromatase Inhibitor Plus Everolimus|"Aromatase inhibitor plus everolimus by mouth daily for 26 weeks~Everolimus: Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:~Anastrozole 1 mg~Letrozole 2.5 mg~Exemestane 25 mg"
10792101|NCT02236572|OG000|Outcome|Aromatase Inhibitor Plus Everolimus|"Aromatase inhibitor plus everolimus by mouth daily for 26 weeks~Everolimus: Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:~Anastrozole 1 mg~Letrozole 2.5 mg~Exemestane 25 mg"
10792102|NCT02236572|EG000|Reported Event|Aromatase Inhibitor Plus Everolimus|"Aromatase inhibitor plus everolimus by mouth daily for 26 weeks~Everolimus: Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:~Anastrozole 1 mg~Letrozole 2.5 mg~Exemestane 25 mg"
10792103|NCT02083354|BG000|Baseline|Arm 1|All subjects received the combination of dabrafenib (150 mg) and trametinib (2 mg) in the morning at approximately the same time every day. The second dose of dabrafenib (150 mg) alone was to be administered approximately 12 hours after the morning dose. Subjects were to continue study treatment until disease progression, death, unacceptable toxicity, withdrawal of consent, or study closure
11195416|NCT02158520|OG001|Outcome|Arm B (Ipilimumab)|Patients receive ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm A within 2-4 weeks.
10792104|NCT02083354|FG000|Participant Flow|Arm 1|All subjects received the combination of dabrafenib (150 mg) and trametinib (2 mg) in the morning at approximately the same time every day. The second dose of dabrafenib (150 mg) alone was to be administered approximately 12 hours after the morning dose. Subjects were to continue study treatment until disease progression, death, unacceptable toxicity, withdrawal of consent, or study closure
11195417|NCT02158520|EG000|Reported Event|Arm A (Bevacizumab and Nab-paclitaxel)|Patients receive bevacizumab 10mg/kg IV over 30-90 minutes on days 1 and 15 and nab-paclitaxel 150 mg/m^2 IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm B within 2-4 weeks.
11195418|NCT02158520|EG001|Reported Event|Arm B (Ipilimumab)|Patients receive ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm A within 2-4 weeks.
11195419|NCT02158520|EG002|Reported Event|Arm A Eligible for Crossover|Arm A patients who experienced progressive disease and eligible for crossover to Arm B AND evaluated for adverse events.
11195420|NCT02158520|EG003|Reported Event|Arm B Eligible for Crossover|Arm B patients who experienced progressive disease and eligible for crossover to Arm A AND evaluated for adverse events.
11195421|NCT02158533|BG000|Baseline|Placebo S1|Randomized to placebo in Stage 1
11195422|NCT02158533|BG001|Baseline|ALKS 5461 0.5mg/0.5mg S1|Randomized to ALKS 0.5mg/0.5mg in Stage 1
11195423|NCT02158533|BG002|Baseline|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2/2 in Stage 1
11195424|NCT02158533|BG003|Baseline|Total|Total of all reporting groups
11195425|NCT02158533|FG000|Participant Flow|Placebo S1|Randomized to placebo in Stage 1
11195426|NCT02158533|FG001|Participant Flow|ALKS 5461 0.5mg/0.5mg S1|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
11195427|NCT02158533|FG002|Participant Flow|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
11195428|NCT02158533|FG003|Participant Flow|Placebo S2|Randomized to placebo in Stage 2
11195429|NCT02158533|FG004|Participant Flow|ALKS 5461 0.5mg/0.5mg S2|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
11195430|NCT02158533|FG005|Participant Flow|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11195431|NCT02158533|OG000|Outcome|Placebo S1|Randomized to placebo in Stage 1
11195432|NCT02158533|OG001|Outcome|ALKS 5461 0.5mg/0.5mg S1|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
11195433|NCT02158533|OG002|Outcome|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
11195434|NCT02158533|OG003|Outcome|Placebo S2|Randomized to placebo in Stage 2
11195435|NCT02158533|OG004|Outcome|ALKS 5461 0.5mg/0.5mg S2|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
11195436|NCT02158533|OG005|Outcome|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11195437|NCT02158533|EG000|Reported Event|Placebo S1|Randomized to placebo in Stage 1
11195438|NCT02158533|EG001|Reported Event|ALKS 5461 0.5mg/0.5mg S1|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
11195439|NCT02158533|EG002|Reported Event|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
11195440|NCT02158533|EG003|Reported Event|Placebo S2|Randomized to placebo in Stage 2
11195441|NCT02158533|EG004|Reported Event|ALKS 5461 0.5mg/0.5mg S2|Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
11195442|NCT02158533|EG005|Reported Event|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11195443|NCT02158546|BG000|Baseline|Group 1 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195444|NCT02158546|BG001|Baseline|Group 1 Placebo|Randomized to placebo
11195445|NCT02158546|BG002|Baseline|Group 2 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195446|NCT02158546|BG003|Baseline|Group 2 Placebo|Randomized to placebo
11195447|NCT02158546|BG004|Baseline|Total|Total of all reporting groups
11195448|NCT02158546|FG000|Participant Flow|Group 1 - ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195449|NCT02158546|FG001|Participant Flow|Group 1 - Placebo|Randomized to Placebo
11195450|NCT02158546|FG002|Participant Flow|Group 2 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195451|NCT02158546|FG003|Participant Flow|Group 2 - Placebo|Randomized to placebo
11195452|NCT02158546|OG000|Outcome|ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195453|NCT02158546|OG001|Outcome|Placebo|Randomized to placebo
11195454|NCT02158546|OG002|Outcome|Group 2 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195455|NCT02158546|OG003|Outcome|Group 2 Placebo|Randomized to placebo
11195456|NCT02158546|EG000|Reported Event|Group 1 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195457|NCT02158546|EG001|Reported Event|Group 1 Placebo|Randomized to placebo
11195458|NCT02158546|EG002|Reported Event|Group 2 ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg
11195459|NCT02158546|EG003|Reported Event|Group 2 Placebo|Randomized to placebo
11195460|NCT02158572|BG000|Baseline|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
11195461|NCT02158572|FG000|Participant Flow|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
11195462|NCT02158572|OG000|Outcome|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
11195463|NCT02158572|EG000|Reported Event|AG200-15|"AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)~AG200-15: Transdermal contraceptive delivery system"
10792105|NCT02083354|OG000|Outcome|Arm 1|All subjects received the combination of dabrafenib (150 mg) and trametinib (2 mg) in the morning at approximately the same time every day. The second dose of dabrafenib (150 mg) alone was to be administered approximately 12 hours after the morning dose. Subjects were to continue study treatment until disease progression, death, unacceptable toxicity, withdrawal of consent, or study closure
10792106|NCT02083354|EG000|Reported Event|All Patients|All Patients
10792107|NCT01775813|BG000|Baseline|Normal Weight|Normal Weight by BMI. No treatment.
10792108|NCT01775813|BG001|Baseline|Obese - NT|Obese by BMI. Participants were not taking metformin or placebo
10792109|NCT01775813|BG002|Baseline|Obese - Placebo|Dosage form: Stamped placebo pill to look like the 1000 mg metformin pill Dosage: 1 pill taken orally twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792110|NCT01775813|BG003|Baseline|Obese - Metformin|Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792111|NCT01775813|BG004|Baseline|Total|Total of all reporting groups
10792112|NCT01775813|FG000|Participant Flow|Normal Weight|Normal Weight by BMI. No treatment.
10792113|NCT01775813|FG001|Participant Flow|Obese - NT|Obese by BMI. These participants were not prescribed any intervention (Non-treated).
10792114|NCT01775813|FG002|Participant Flow|Obese - Placebo|Dosage form: Stamped placebo pill to look like the 1000 mg metformin pill Dosage: 1 pill taken orally twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
11241184|NCT02485158|BG000|Baseline|Healthy Adult Volunteers|All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
10792115|NCT01775813|FG003|Participant Flow|Obese - Metformin|Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792116|NCT01775813|OG000|Outcome|Normal Weight|Normal Weight by BMI. No treatment.
10792117|NCT01775813|OG001|Outcome|Obese - NT|Obese by BMI. These participants were not assigned an intervention (non-treated).
10792118|NCT01775813|OG002|Outcome|Obese - Placebo|Dosage form: Stamped placebo pill to look like the 1000 mg metformin pill Dosage: 1 pill taken orally twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792119|NCT01775813|OG003|Outcome|Obese - Metformin|Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792120|NCT01775813|OG000|Outcome|Normal Weight|Normal Weight by BMI. No treatment
10792121|NCT01775813|OG001|Outcome|Obese - NT/Placebo|Obese by BMI. Mixture of non treated and placebo treated patients.
10792122|NCT01775813|OG000|Outcome|Normal Weight|Normal weight by BMI. No treatment.
10792123|NCT01775813|OG001|Outcome|Obese - NT/Placebo|Obese by BMI. Mix of untreated and Obese-placebo treated.
10792124|NCT01775813|OG002|Outcome|Obese - Metformin|Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792125|NCT01775813|OG003|Outcome|Obese - Placebo|Dosage form: Stamped placebo pill to look like the 1000 mg metformin pill Dosage: 1 pill taken orally twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792126|NCT01775813|OG001|Outcome|Obese NT/Placebo|Obese by BMI. Mix of untreated and Obese-placebo treated.
10792127|NCT01775813|EG000|Reported Event|Obese - Metformin|"Dosage form: Metformin 1000 mg tablets Dosage: 1000 mg by mouth twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years~Metformin: After randomization, the study drug (metformin or placebo) is gradually titrated to full dose of 1000 mg BID (or to maximum tolerated, at least 500 mg BID) over a period of 4 weeks to minimize adverse gastrointestinal effects. Participants are seen every three months to measure compliance and dispense new study drug. Every 6 months, they also have a physical examination in order to determine puberty staging. Study measurements (IVGTT, bloodwork, DXA) are performed at Tanner 4 puberty and Tanner 5 (puberty completion), at which time the study drug is stopped. Study measurements will be performed again 6 months after study drug is completed to assess if effects are persistent after study drug is stopped. During the treatment period, all participants receive standard lifestyle counseling."
10792128|NCT01775813|EG001|Reported Event|Obese - Placebo|Dosage form: Stamped placebo pill to look like the 1000 mg metformin pill Dosage: 1 pill taken orally twice daily Duration: From early puberty (Tanner 3-4) until puberty completion (Tanner 5), approximately 3 years
10792129|NCT01775813|EG002|Reported Event|Normal Weight (No Treatment)|Normal Weight by BMI. No treatment.
10792130|NCT01775813|EG003|Reported Event|Obese (No Treatment)|Obese by BMI. These participants were not prescribed any intervention (Non-treated).
10792131|NCT01694069|BG000|Baseline|All Study Participants|"Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms.~Continuous infusion piperacillin-tazobactam:~Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day~Continuous infusion piperacillin-tazobactam:~Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10965759|NCT00883740|FG000|Participant Flow|Placebo, Then Pregabalin|Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
10792132|NCT01694069|FG000|Participant Flow|All Study Participants|"Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms.~Continuous infusion piperacillin-tazobactam:~Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day~Continuous infusion piperacillin-tazobactam:~Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10792133|NCT01694069|OG000|Outcome|Intermittent Infusion Piperacillin-tazobactam|"Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10792134|NCT01694069|OG001|Outcome|Continuous Infusion Piperacillin-tazobactam|"Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10792135|NCT01694069|EG000|Reported Event|Intermittent Infusion Piperacillin-tazobactam|"Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10792136|NCT01694069|EG001|Reported Event|Continuous Infusion Piperacillin-tazobactam|"Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily~Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion"
10792137|NCT01446016|BG000|Baseline|Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy|"Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles.~Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.~Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks~Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.~Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks."
10792138|NCT01446016|FG000|Participant Flow|Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy|"Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles.~Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.~Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks~Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.~Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks."
10792139|NCT01446016|OG000|Outcome|Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy|"Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles.~Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.~Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks~Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.~Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks."
10792140|NCT01446016|EG000|Reported Event|Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy|"Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles.~Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.~Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks~Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.~Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks."
10792141|NCT01445327|BG000|Baseline|Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant."
10792142|NCT01445327|BG001|Baseline|Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant."
10792143|NCT01445327|BG002|Baseline|Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant."
10792144|NCT01445327|BG003|Baseline|Total|Total of all reporting groups
10792145|NCT01445327|FG000|Participant Flow|Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant."
10792146|NCT01445327|FG001|Participant Flow|Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant."
10792147|NCT01445327|FG002|Participant Flow|Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant."
10792148|NCT01445327|OG000|Outcome|Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant."
10792149|NCT01445327|OG001|Outcome|Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant."
10792150|NCT01445327|OG002|Outcome|Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant."
10792151|NCT01445327|EG000|Reported Event|Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant."
10792152|NCT01445327|EG001|Reported Event|Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant."
10792153|NCT01445327|EG002|Reported Event|Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda|"Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.~Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant."
10792154|NCT01411332|BG000|Baseline|Arm I: SIMRT|"'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.~SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV)."
10792155|NCT01411332|BG001|Baseline|Arm II: HTIMRT|"Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.~HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions."
10792156|NCT01411332|BG002|Baseline|Total|Total of all reporting groups
10792157|NCT01411332|FG000|Participant Flow|Arm I: SIMRT|"'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.~SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV)."
10792158|NCT01411332|FG001|Participant Flow|Arm II: HTIMRT|"All participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of a total of 38 fractions over 7.5 weeks.~HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions."
10792159|NCT01411332|OG000|Outcome|Arm I: SIMRT|"'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.~SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV)."
10792160|NCT01411332|OG001|Outcome|Arm II: HTIMRT|"Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.~HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions."
10792161|NCT01411332|EG000|Reported Event|Arm I: SIMRT|"'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.~SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV)."
10792162|NCT01411332|EG001|Reported Event|Arm II: HTIMRT|"Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.~HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions."
10792163|NCT01399918|BG000|Baseline|Everolimus and Bevacizumab|This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
10792164|NCT01399918|FG000|Participant Flow|Everolimus and Bevacizumab|This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
10792165|NCT01399918|OG000|Outcome|Everolimus and Bevacizumab|This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
10792166|NCT01399918|EG000|Reported Event|Everolimus and Bevacizumab|This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
10792167|NCT01377753|BG000|Baseline|Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation|"Eligible subjects will undergo MR thermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.~Visualase Thermal Therapy System: Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue."
10792168|NCT01377753|FG000|Participant Flow|Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation|"Eligible subjects will undergo MR thermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.~Visualase Thermal Therapy System: Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue."
10792169|NCT01377753|OG000|Outcome|Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation|"Eligible subjects will undergo MR thermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.~Visualase Thermal Therapy System: Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue."
10792170|NCT01377753|EG000|Reported Event|Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation|"Eligible subjects will undergo MR thermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.~Visualase Thermal Therapy System: Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue."
10792171|NCT01147653|BG000|Baseline|Autologous UCB First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
10792172|NCT01147653|BG001|Baseline|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
10792173|NCT01147653|BG002|Baseline|Total|Total of all reporting groups
10792174|NCT01147653|FG000|Participant Flow|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
10792175|NCT01147653|FG001|Participant Flow|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
10792176|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
10792177|NCT01147653|OG001|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
10792178|NCT01147653|OG000|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
10792179|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First,Then Placebo|"Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.~Autologous UCB Reinfusion: Autologous umbilical cord blood (UCB) reinfusion~Placebo: Placebo"
10792180|NCT01147653|OG001|Outcome|Placebo First, Then Autologous UCB Reinfusion|"Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.~Autologous UCB Reinfusion: Autologous umbilical cord blood (UCB) reinfusion~Placebo: Placebo"
10792181|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
10792182|NCT01147653|OG001|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
10792183|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
10792184|NCT01147653|OG001|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
10792185|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
10792186|NCT01147653|OG000|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than Placebo at Year 1.
10792187|NCT01147653|OG001|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
10792188|NCT01147653|OG000|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
10792189|NCT01147653|OG000|Outcome|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
10792190|NCT01147653|EG000|Reported Event|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
10792191|NCT01147653|EG001|Reported Event|Placebo|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
10792192|NCT01078454|BG000|Baseline|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
10792193|NCT01078454|BG001|Baseline|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
10792194|NCT01078454|BG002|Baseline|Total|Total of all reporting groups
10792195|NCT01078454|FG000|Participant Flow|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
10792196|NCT01078454|FG001|Participant Flow|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
10792197|NCT01078454|OG000|Outcome|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
10792198|NCT01078454|OG001|Outcome|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
10792199|NCT01078454|EG000|Reported Event|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
10792200|NCT01078454|EG001|Reported Event|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
10792201|NCT00687596|BG000|Baseline|TAC-101|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a dose of 20 mg/day of TAC-101 (as second line treatment) oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period on Days 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792202|NCT00687596|BG001|Baseline|Placebo|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a matching placebo for TAC-101 oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period from on 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792203|NCT00687596|BG002|Baseline|Total|Total of all reporting groups
10792204|NCT00687596|FG000|Participant Flow|TAC-101|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a dose of 20 milligram per day (mg/day) of TAC-101 (as second line treatment) oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period on Days 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792205|NCT00687596|FG001|Participant Flow|Placebo|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a matching placebo for TAC-101 oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period from on 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792206|NCT00687596|OG000|Outcome|TAC-101|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a dose of 20 mg/day of TAC-101 (as second line treatment) oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period on Days 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792207|NCT00687596|OG001|Outcome|Placebo|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a matching placebo for TAC-101 oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period from on 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792208|NCT00687596|EG000|Reported Event|TAC-101|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a dose of 20 mg/day of TAC-101 (as second line treatment) oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period on Days 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792209|NCT00687596|EG001|Reported Event|Placebo|Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a matching placebo for TAC-101 oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period from on 15 to 21 in 21-day cycle until disease progression or participant met a treatment discontinuation criterion.
10792210|NCT00458536|BG000|Baseline|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
10792211|NCT00458536|FG000|Participant Flow|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
10792212|NCT00458536|OG000|Outcome|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
10792213|NCT00458536|EG000|Reported Event|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
10792214|NCT00112840|BG000|Baseline|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792215|NCT00112840|BG001|Baseline|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792216|NCT00112840|BG002|Baseline|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10792217|NCT00112840|BG003|Baseline|Total|Total of all reporting groups
10792218|NCT00112840|FG000|Participant Flow|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792219|NCT00112840|FG001|Participant Flow|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792220|NCT00112840|FG002|Participant Flow|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
11241185|NCT02485158|FG000|Participant Flow|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
10792221|NCT00112840|OG000|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10792222|NCT00112840|OG001|Outcome|Phase 1 , Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792223|NCT00112840|OG002|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10965760|NCT00883740|FG001|Participant Flow|Pregabalin, Then Placebo|Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
10792224|NCT00112840|OG000|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10792225|NCT00112840|OG001|Outcome|Phase 1, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792226|NCT00112840|OG000|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10792227|NCT00112840|OG000|Outcome|Phase 1, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10792228|NCT00112840|OG001|Outcome|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792229|NCT00112840|EG000|Reported Event|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792230|NCT00112840|EG001|Reported Event|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10792231|NCT00112840|EG002|Reported Event|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
10802635|NCT02522715|EG001|Reported Event|Phase II - Treatment (Cabazitaxel, Enzalutamide)|"Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Prednisone: Given PO"
10802636|NCT02487095|BG000|Baseline|Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5|Phase I Dose Level (DL) 1 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 5
10802637|NCT02487095|BG001|Baseline|Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 2 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802638|NCT02487095|BG002|Baseline|Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 3 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802639|NCT02487095|BG003|Baseline|Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5
10802640|NCT02487095|BG004|Baseline|Phase II DL4 Topotecan 1.25mg/m^2 VX970 (M6620) 210mg/m^2 Recommended Phase II Dose|"Phase I Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5 Maximum Tolerated Dose/Recommended Phase II Dose~26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group."
10802641|NCT02487095|BG005|Baseline|Total|Total of all reporting groups
10965761|NCT00883740|OG000|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
11241186|NCT02485158|OG000|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11241187|NCT02485158|OG001|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11383186|NCT02497612|BG001|Baseline|Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
11383187|NCT02497612|BG002|Baseline|Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
11383188|NCT02497612|BG003|Baseline|Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg
11383189|NCT02497612|BG004|Baseline|Total|Total of all reporting groups
11383190|NCT02497612|FG000|Participant Flow|Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams [mg]) oral suspension as follows: BW greater than or equal to (>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
11383191|NCT02497612|FG001|Participant Flow|Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
11383192|NCT02497612|FG002|Participant Flow|Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
11383193|NCT02497612|FG003|Participant Flow|Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
11383194|NCT02497612|OG000|Outcome|Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
11383195|NCT02497612|OG001|Outcome|Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
11383196|NCT02497612|OG002|Outcome|Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
11383197|NCT02497612|OG003|Outcome|Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
11383198|NCT02497612|EG000|Reported Event|Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
11383199|NCT02497612|EG001|Reported Event|Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
11383200|NCT02497612|EG002|Reported Event|Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
11383201|NCT02497612|EG003|Reported Event|Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)|On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
11383202|NCT02460458|BG000|Baseline|Type 3 Von Willebrand's Disease (VWD3)|Patients with diagnosis of Type 3 Von Willebrand's Disease (VWD3)
11383203|NCT02460458|FG000|Participant Flow|Type 3 Von Willebrand's Disease (VWD3)|Patients with diagnosis of Type 3 Von Willebrand's Disease (VWD3). In the Retrospective Phase, the retrospective data of the participants were collected and analyzed, and a blood sample was drawn. During the Confirmatory Phase, local VWD3 diagnosis was verified using centralized tests. Participants with a confirmed case of VWD3 were then prospectively observed for two years (First Prospective Phase). After a Confirmation of the Clinical Phase Data, the participants started a Second Prospective Phase, being observed for two additional years.
11383204|NCT02460458|OG000|Outcome|Type 3 Von Willebrand's Disease (VWD3)|Patients with diagnosis of Type 3 Von Willebrand's Disease (VWD3)
11383205|NCT02460458|EG000|Reported Event|Type 3 Von Willebrand's Disease (VWD3)|Patients with diagnosis of Type 3 Von Willebrand's Disease (VWD3)
11383206|NCT02457559|BG000|Baseline|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.
11383207|NCT02457559|BG001|Baseline|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383208|NCT02457559|BG002|Baseline|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383209|NCT02457559|BG003|Baseline|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
11383210|NCT02457559|BG004|Baseline|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
11383211|NCT02457559|BG005|Baseline|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383212|NCT02457559|BG006|Baseline|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.
11383213|NCT02457559|BG007|Baseline|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study
11383214|NCT02457559|BG008|Baseline|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383215|NCT02457559|BG009|Baseline|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
11383216|NCT02457559|BG010|Baseline|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383217|NCT02457559|BG011|Baseline|Total|Total of all reporting groups
11383218|NCT02457559|FG000|Participant Flow|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 80 mg once daily for up to 96 months from first dose in parent study.
11383219|NCT02457559|FG001|Participant Flow|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383220|NCT02457559|FG002|Participant Flow|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383221|NCT02457559|FG003|Participant Flow|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
11383222|NCT02457559|FG004|Participant Flow|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
10792232|NCT04957732|BG000|Baseline|Standard of Care (SoC)|For subjects randomized to the control group, Standard of Care (SoC) (normal saline) was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
11383223|NCT02457559|FG005|Participant Flow|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383224|NCT02457559|FG006|Participant Flow|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.
11383225|NCT02457559|FG007|Participant Flow|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383226|NCT02457559|FG008|Participant Flow|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383227|NCT02457559|FG009|Participant Flow|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
11383228|NCT02457559|FG010|Participant Flow|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383229|NCT02457559|OG000|Outcome|Tirabrutinib 40 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.
11383230|NCT02457559|OG001|Outcome|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.
11383231|NCT02457559|OG002|Outcome|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383232|NCT02457559|OG003|Outcome|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383233|NCT02457559|OG004|Outcome|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
10792233|NCT04957732|BG001|Baseline|Irrisept|For subjects randomized to the investigational group, Irrisept was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
11383234|NCT02457559|OG005|Outcome|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
11383235|NCT02457559|OG006|Outcome|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383236|NCT02457559|OG007|Outcome|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily (BID) for up to 96 months from first dose in the parent study.
11383237|NCT02457559|OG008|Outcome|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383238|NCT02457559|OG009|Outcome|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383239|NCT02457559|OG010|Outcome|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
11383240|NCT02457559|OG011|Outcome|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383241|NCT02457559|OG007|Outcome|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.
11383242|NCT02457559|OG000|Outcome|Tirabrutinib 80 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.
11383243|NCT02457559|OG001|Outcome|Tirabrutinib 160 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383244|NCT02457559|OG002|Outcome|Tirabrutinib 320 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383245|NCT02457559|OG003|Outcome|Tirabrutinib 400 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
11383246|NCT02457559|OG004|Outcome|Tirabrutinib 500 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
11383247|NCT02457559|OG005|Outcome|Tirabrutinib 600 mg Once Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383248|NCT02457559|OG006|Outcome|Tirabrutinib 300 mg Twice Daily (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.
11383249|NCT02457559|OG007|Outcome|Tirabrutinib 160 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383250|NCT02457559|OG008|Outcome|Tirabrutinib 320 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383251|NCT02457559|OG009|Outcome|Tirabrutinib 480 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
11383252|NCT02457559|OG010|Outcome|Tirabrutinib 600 mg Once Daily (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
10792234|NCT04957732|BG002|Baseline|Total|Total of all reporting groups
10792235|NCT04957732|FG000|Participant Flow|Standard of Care (SoC)|"For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.~SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing."
10792236|NCT04957732|FG001|Participant Flow|Irrisept|"For subjects randomized to the investigational group, Irrisept was used.~Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The device has an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing."
10792237|NCT04957732|OG000|Outcome|Standard of Care (SoC)|"For subjects randomized to SoC, normal saline was used.~Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing."
10792238|NCT04957732|OG001|Outcome|Irrisept|"For subjects randomized to the investigational group, Irrisept was used.~Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing."
10792239|NCT04957732|OG000|Outcome|Standard of Care (SoC)|"For subjects randomized to SoC, normal saline was used.~Assessments were made at the initial visit and 48-hour visit interval."
10792240|NCT04957732|OG001|Outcome|Irrisept|"For subjects randomized to the investigational group, Irrisept was used.~Assessments were made at the initial visit and 48-hour visit interval."
10792241|NCT04957732|OG000|Outcome|Standard of Care|"For subjects randomized to SoC, normal saline was used.~Assessments were made at the initial visit and 48-hour visit interval."
10792242|NCT04957732|OG000|Outcome|Standard of Care (SoC)|"For subjects randomized to SoC, normal saline was used.~Assessments were made, beginning at the time of informed consent, until study completion."
10792243|NCT04957732|OG001|Outcome|Irrisept|"For subjects randomized to the investigational group, Irrisept was used.~Assessments were made, beginning at the time of informed consent, until study completion."
11195464|NCT02158663|BG000|Baseline|Right Slow Prefrontal rTMS|"For those randomized to 1 Hz frequency, the 1 Hz rTMS was continuous for 40 minutes for a total of 2400 pulses/session.~The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. Testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles."
10792244|NCT04957732|EG000|Reported Event|Standard of Care (SoC)|"For subjects randomized to SoC, normal saline was used.~Assessments were made anytime after consent, while the study participated in the trial."
10792245|NCT04957732|EG001|Reported Event|Irrisept|"For subjects randomized to the investigational group, Irrisept was used.~Assessments were made anytime after consent, while the study participated in the trial."
10802642|NCT02487095|FG000|Participant Flow|Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5|Phase I Dose Level (DL) 1 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 5
10802643|NCT02487095|FG001|Participant Flow|Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 2 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802644|NCT02487095|FG002|Participant Flow|Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 3 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802645|NCT02487095|FG003|Participant Flow|Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5
10802646|NCT02487095|FG004|Participant Flow|Phase II DL4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5 Maximum Tolerated Dose/ Recommended Phase II Dose.~26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group."
10802647|NCT02487095|OG000|Outcome|All Participants|All participants in phase I DL1-DL4.
10802648|NCT02487095|OG000|Outcome|Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose."
10802649|NCT02487095|OG001|Outcome|Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose."
10802650|NCT02487095|OG000|Outcome|Phase I DL 1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5|Phase I Dose Level (DL) 1 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 5
10802651|NCT02487095|OG001|Outcome|Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 2 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802652|NCT02487095|OG002|Outcome|Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 3 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802653|NCT02487095|OG003|Outcome|Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5
10965762|NCT00883740|OG001|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
10792246|NCT04207749|BG000|Baseline|Biofinity|Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792247|NCT04207749|BG001|Baseline|LID015385|LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792248|NCT04207749|BG002|Baseline|Total|Total of all reporting groups
10792249|NCT04207749|FG000|Participant Flow|Biofinity|Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792250|NCT04207749|FG001|Participant Flow|LID015385|LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792251|NCT04207749|OG000|Outcome|Biofinity|Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792252|NCT04207749|OG001|Outcome|LID015385|LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
10792253|NCT04207749|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
10792254|NCT04207749|EG001|Reported Event|Biofinity - Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
10792255|NCT04207749|EG002|Reported Event|Biofinity - Nonocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
10792256|NCT04207749|EG003|Reported Event|LID015385 - Ocular|Events reported in this group occurred while exposed to LID015385 contact lenses
10792257|NCT04207749|EG004|Reported Event|LID015385 - Nonocular|Events reported in this group occurred while exposed to LID015385 contact lenses
10802654|NCT02487095|OG004|Outcome|Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose.~26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group."
10802655|NCT02487095|OG000|Outcome|Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5|Phase I Dose Level (DL) 1 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 5
10802656|NCT02487095|OG001|Outcome|Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 2 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802657|NCT02487095|OG004|Outcome|Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose."
10802658|NCT02487095|OG005|Outcome|Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose."
10802659|NCT02487095|OG004|Outcome|Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose.~Small cell lung cancer (SCLC) participants only."
10802660|NCT02487095|EG000|Reported Event|Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5|Phase I Dose Level (DL) 1 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 5
10802661|NCT02487095|EG001|Reported Event|Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 2 Topotecan 1mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802662|NCT02487095|EG002|Reported Event|Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 3 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m^2 IV on day 2, 5
10802663|NCT02487095|EG003|Reported Event|Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5|Phase I Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5
10802664|NCT02487095|EG004|Reported Event|Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose|"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m^2 IV on day 2, 5.~Maximum Tolerated Dose/Recommended Phase II Dose.~26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group."
10802665|NCT02347917|BG000|Baseline|MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802666|NCT02347917|BG001|Baseline|MPM: BBI608 + Pem + CDDP (Phase 2 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802667|NCT02347917|BG002|Baseline|Total|Total of all reporting groups
10802668|NCT02347917|FG000|Participant Flow|MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10792258|NCT04167345|BG000|Baseline|Parts A1, A2 and B Combined: Placebo|Participants received placebo matched to VX-814 in the treatment period for 28 days.
10792259|NCT04167345|BG001|Baseline|Part A1: VX-814 100 mg|Participants received VX-814 100 mg q12h in the treatment period for 28 days.
10792260|NCT04167345|BG002|Baseline|Part A1: VX-814 200 mg|Participants received VX-814 200 mg q12h in the treatment period for 28 days.
10792261|NCT04167345|BG003|Baseline|Parts A1 and A2 Combined: VX-814 400 mg|Participants received VX-814 400 mg q12h in the treatment period for 28 days.
10792262|NCT04167345|BG004|Baseline|Part B: VX-814 600 mg|Participants received VX-814 600 mg q12h in the treatment period for 28 days.
10792263|NCT04167345|BG005|Baseline|Total|Total of all reporting groups
10792264|NCT04167345|FG000|Participant Flow|Parts A1, A2 and B Combined: Placebo|Participants received placebo matched to VX-814 in the treatment period for 28 days.
10792265|NCT04167345|FG001|Participant Flow|Part A1: VX-814 100 mg|Participants received VX-814 100 mg once every 12 hours (q12h) in the treatment period for 28 days.
10792266|NCT04167345|FG002|Participant Flow|Part A1: VX-814 200 mg|Participants received VX-814 200 mg q12h in the treatment period for 28 days.
10792267|NCT04167345|FG003|Participant Flow|Parts A1 and A2 Combined: VX-814 400 mg|Participants received VX-814 400 mg q12h in the treatment period for 28 days.
10792268|NCT04167345|FG004|Participant Flow|Part B: VX-814 600 mg|Participants received VX-814 600 mg q12h in the treatment period for 28 days.
10792269|NCT04167345|OG000|Outcome|Parts A1, A2 and B Combined: Placebo|Participants received placebo matched to VX-814 in the treatment period for 28 days.
10792270|NCT04167345|OG001|Outcome|Part A1: VX-814 100 mg|Participants received VX-814 100 mg q12h in the treatment period for 28 days.
10792271|NCT04167345|OG002|Outcome|Part A1: VX-814 200 mg|Participants received VX-814 200 mg q12h in the treatment period for 28 days.
10792272|NCT04167345|OG003|Outcome|Parts A1 and A2 Combined: VX-814 400 mg|Participants received VX-814 400 mg q12h in the treatment period for 28 days.
10792273|NCT04167345|OG004|Outcome|Part B: VX-814 600 mg|Participants received VX-814 600 mg q12h in the treatment period for 28 days.
10965763|NCT00883740|EG000|Reported Event|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
10792274|NCT04167345|OG000|Outcome|Part A1: VX-814 100 mg|Participants received VX-814 100 mg q12h in the treatment period for 28 days.
10792275|NCT04167345|OG001|Outcome|Part A1: VX-814 200 mg|Participants received VX-814 200 mg q12h in the treatment period for 28 days.
10792276|NCT04167345|OG002|Outcome|Parts A1 and A2 Combined: VX-814 400 mg|Participants received VX-814 400 mg q12h in the treatment period for 28 days.
10792277|NCT04167345|OG003|Outcome|Part B: VX-814 600 mg|Participants received VX-814 600 mg q12h in the treatment period for 28 days.
10792278|NCT04167345|EG000|Reported Event|Parts A1, A2 and B Combined: Placebo|Participants received placebo matched to VX-814 in the treatment period for 28 days.
10792279|NCT04167345|EG001|Reported Event|Part A1: VX-814 100 mg|Participants received VX-814 100 mg q12h in the treatment period for 28 days.
10792280|NCT04167345|EG002|Reported Event|Part A1: VX-814 200 mg|Participants received VX-814 200 mg q12h in the treatment period for 28 days.
10792281|NCT04167345|EG003|Reported Event|Parts A1 and A2 Combined: VX-814 400 mg|Participants received VX-814 400 mg q12h in the treatment period for 28 days.
10792282|NCT04167345|EG004|Reported Event|Part B: VX-814 600 mg|Participants received VX-814 600 mg q12h in the treatment period for 28 days.
10792283|NCT04042077|BG000|Baseline|Delafloxacin|Delafloxacin IV with the option to switch to OS
10792284|NCT04042077|BG001|Baseline|Best Available Therapy|Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
10792285|NCT04042077|BG002|Baseline|Total|Total of all reporting groups
10792286|NCT04042077|FG000|Participant Flow|Delafloxacin|"Delafloxacin IV, with the option to switch to delafloxacin oral~Delafloxacin: Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days"
10792287|NCT04042077|FG001|Participant Flow|Best Available Therapy|"Cardiothoracic / related leg SSI~Vancomycin IV~Linezolid IV, with the option to switch to linezolid oral.~In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice~Abdominal SSI~Piperacillin/Tazobactam IV, OR~Tigecycline IV~In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.~Vancomycin: Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days~Linezolid: Solution for infusion or tablet, 600 mg BID, for 5 to 14 days~Piperacillin/Tazobactam: Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days~Tigecycline: Powder for solution for infusion 50 mg, TID, for 5 to 14 days"
10792288|NCT04042077|OG000|Outcome|Delafloxacin|Delafloxacin IV with the option to switch to OS
10792289|NCT04042077|OG001|Outcome|Best Available Therapy|Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
10792290|NCT04042077|OG000|Outcome|Delafloxacin|Delafloxacin IV with the option to switch to delafloxacin OS
10792291|NCT04042077|OG001|Outcome|Best Available Therapy|"Vancomycin and Linezolid for cardiothoracic SSI~Piperacillin/Tazobactam and Tigecycline for abdominal SSI"
10792292|NCT04042077|EG000|Reported Event|Delafloxacin|Delafloxacin IV with the option to switch to delafloxacin OS
10792293|NCT04042077|EG001|Reported Event|Best Available Therapy|"Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI~The results are not reported per intervention since the study was not powered to highlight difference between delafloxacin and each reference treatment. The safety analysis aimed to demonstrate that delafloxacin, among the fluoroquinolone class, is atypical showing a favourable safety profile very similar to NON-fluoroquinoles."
10792294|NCT04042077|EG002|Reported Event|Linezolid|Linezolid IV with the option to switch to delafloxacin OS
10792295|NCT04042077|EG003|Reported Event|Vancomycin|Vancomycin IV
10792296|NCT04042077|EG004|Reported Event|Piperacillin/Tazobactam|Piperacillin/Tazobactam IV
10965764|NCT00883740|EG001|Reported Event|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
10792297|NCT04042077|EG005|Reported Event|Tigecycline|Tigecycline IV
10792298|NCT04001803|BG000|Baseline|Participants With HIV Infection|Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
10792299|NCT04001803|FG000|Participant Flow|Participants With HIV Infection|Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
10792300|NCT04001803|OG000|Outcome|Staff Study Participants|Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
10792301|NCT04001803|OG000|Outcome|Participants With HIV Infection|Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
10792302|NCT04001803|EG000|Reported Event|Participants With HIV Infection|Participants received one tablet of CAB 30 milligrams (mg) + RPV 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB LA + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until participants completed/discontinued the study intervention.
10792303|NCT03936699|BG000|Baseline|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Behavioral: Diet & Exercise Subjects to be instructed on a healthy 1200 calorie diet.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792304|NCT03936699|BG001|Baseline|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792305|NCT03936699|BG002|Baseline|Total|Total of all reporting groups
10792306|NCT03936699|FG000|Participant Flow|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Behavioral: Diet & Exercise Subjects to be instructed on a healthy 1200 calorie diet.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792307|NCT03936699|FG001|Participant Flow|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792308|NCT03936699|OG000|Outcome|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Behavioral: Diet & Exercise Subjects to be instructed on a healthy 1200 calorie diet.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792309|NCT03936699|OG001|Outcome|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792310|NCT03936699|EG000|Reported Event|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Behavioral: Diet & Exercise Subjects to be instructed on a healthy 1200 calorie diet.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792311|NCT03936699|EG001|Reported Event|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
10792312|NCT03925324|BG000|Baseline|Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|"Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.~Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg"
10792313|NCT03925324|BG001|Baseline|Placebo|"Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.~Placebo: 1.5 mL/kg Lactated Ringer's Solution"
10792314|NCT03925324|BG002|Baseline|Total|Total of all reporting groups
10792315|NCT03925324|FG000|Participant Flow|Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|"Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.~Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg"
10792316|NCT03925324|FG001|Participant Flow|Placebo|"Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.~Placebo: 1.5 mL/kg Lactated Ringer's Solution"
10792317|NCT03925324|OG000|Outcome|Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|"Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.~Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg"
10792318|NCT03925324|OG001|Outcome|Placebo|"Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.~Placebo: 1.5 mL/kg Lactated Ringer's Solution"
10792319|NCT03925324|EG000|Reported Event|Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|"Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.~Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC): Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg"
10792320|NCT03925324|EG001|Reported Event|Placebo|"Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.~Placebo: 1.5 mL/kg Lactated Ringer's Solution"
10792321|NCT03875092|BG000|Baseline|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792322|NCT03875092|BG001|Baseline|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792323|NCT03875092|BG002|Baseline|Total|Total of all reporting groups
10792324|NCT03875092|FG000|Participant Flow|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792325|NCT03875092|FG001|Participant Flow|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792326|NCT03875092|OG000|Outcome|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792327|NCT03875092|OG001|Outcome|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792328|NCT03875092|EG000|Reported Event|Pembrolizumab + Chemotherapy|Participants received pembrolizumab 200 mg by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792329|NCT03875092|EG001|Reported Event|Chemotherapy|Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
10792330|NCT03814382|BG000|Baseline|Acupuncture|"All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.~Acupuncture needle: Acupuncture needle"
10792331|NCT03814382|FG000|Participant Flow|Acupuncture|"All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.~Acupuncture needle: Acupuncture needle"
10792332|NCT03814382|OG000|Outcome|Acupuncture|"All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.~Acupuncture needle: Acupuncture needle"
10792333|NCT03814382|EG000|Reported Event|Acupuncture|"All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.~Acupuncture needle: Acupuncture needle"
10802669|NCT02347917|FG001|Participant Flow|MPM: BBI608 + Pem + CDDP (Phase 2 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802670|NCT02347917|OG000|Outcome|MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802671|NCT02347917|OG000|Outcome|MPM: BBI608 + Pem + CDDP (Phase 2 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10792334|NCT03740009|BG000|Baseline|Perimenopausal Women, Depressed|"Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks~Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets"
10792335|NCT03740009|FG000|Participant Flow|Perimenopausal Women, Depressed|"Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks~Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets"
10792336|NCT03740009|OG000|Outcome|Perimenopausal Women, Depressed|"Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks~Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets"
10792337|NCT03740009|EG000|Reported Event|Perimenopausal Women, Depressed|"Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks~Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets"
10792338|NCT03738397|BG000|Baseline|Dupilumab 300 mg EOW|Participants received a loading dose of 600 mg dupilumab by SC injection on Day 1 followed by 300 mg dupilumab SC EOW until Week 22 and placebo to upadacitinib orally QD up to Week 24.
10792339|NCT03738397|BG001|Baseline|Upadacitinib 30 mg QD|Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
10792340|NCT03738397|BG002|Baseline|Total|Total of all reporting groups
10792341|NCT03738397|FG000|Participant Flow|Dupilumab 300 mg EOW|Participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally once a day (QD) up to Week 24.
11195465|NCT02158663|BG001|Baseline|Right Fast Prefrontal rTMS|"For those randomized to 10 Hz, rTMS was 4 seconds on and 36 seconds off for 40 minutes for a total of 2400 pulses/session.~The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. Testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles."
11195466|NCT02158663|BG002|Baseline|Total|Total of all reporting groups
11195467|NCT02158663|FG000|Participant Flow|Right Slow Prefrontal rTMS|"Low frequency 1 Hz group TMS Device:~1 Hz rTMS will be continuous treatment at 110% MT for 40 minutes for a total of 2400 pulses. There are encouraging reports of success using rTMS to treat PTSD symptoms with both fast (greater than 1 Hz) and slow (1 Hz or less) frequency treatments. One unanswered question is whether fast or slow treatments result in a better outcome. This difference in response may be mediated through the moderator of the presence of depressive symptoms. Also, the tolerability of the two treatment parameters may be significantly different. . For those randomized to 1 Hz frequency, the 1 Hz rTMS will be continuous for 40 minutes for a total of 2400 pulses."
10792342|NCT03738397|FG001|Participant Flow|Upadacitinib 30 mg QD|Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
10792343|NCT03738397|OG000|Outcome|Dupilumab 300 mg EOW|Participants received a loading dose of 600 mg dupilumab by SC injection on Day 1 followed by 300 mg dupilumab SC EOW until Week 22 and placebo to upadacitinib orally QD up to Week 24.
10792344|NCT03738397|OG001|Outcome|Upadacitinib 30 mg QD|Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
10792345|NCT03738397|EG000|Reported Event|Dupilumab 300 mg EOW|Participants received a loading dose of 600 mg dupilumab by SC injection on Day 1 followed by 300 mg dupilumab SC EOW until Week 22 and placebo to upadacitinib orally QD up to Week 24.
10792346|NCT03738397|EG001|Reported Event|Upadacitinib 30 mg QD|Participants received 30 mg upadacitinib orally once a day up to Week 24 and placebo to dupilumab SC EOW up to Week 22.
10792347|NCT03666624|BG000|Baseline|Personalized Care Network|"9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks~Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges."
10792348|NCT03666624|BG001|Baseline|Routine Medical Care|No intervention
10792349|NCT03666624|BG002|Baseline|Total|Total of all reporting groups
10792350|NCT03666624|FG000|Participant Flow|Personalized Care Network|"9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks~Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges."
10792351|NCT03666624|FG001|Participant Flow|Routine Medical Care|No intervention
11195468|NCT02158663|FG001|Participant Flow|Right Fast Prefrontal rTMS|"Prefrontal high frequency 10Hz rTMS~The right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS will provide a significantly (two-sided, p ≤ 0.05) greater improvement in depressive symptoms as measured by change in QIDS score..~Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.~The 10 Hz rTMS will be 4 seconds on and 36 seconds off at 110% MT for 40 minutes for a total of 2400 pulses. Cohen et al. 2004 (n=24) reported that 10 Hz significantly improved PTSD symptoms over the right prefrontal cortex compared to sham."
11241188|NCT02485158|OG002|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11383253|NCT02457559|EG000|Reported Event|Tirabrutinib 40 mg QD (CLL)|Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 40 mg once daily (QD) for up to 96 months from first dose in the parent study.
10792352|NCT03666624|OG000|Outcome|Personalized Care Network|"9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks~Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges."
10792353|NCT03666624|OG001|Outcome|Routine Medical Care|No intervention
11195469|NCT02158663|OG000|Outcome|Right Slow Prefrontal rTMS|"Test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score.~Secondary objectives include: one, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; and three, testing whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS is better tolerated as measured by participant drop out and side effect profiles."
11195470|NCT02158663|OG001|Outcome|Right Fast Prefrontal rTMS|Right prefrontal high frequency 10 Hz rTMS; prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD symptoms using the CAPS measure score..
11195471|NCT02158663|OG000|Outcome|Right Slow Prefrontal rTMS|This study is designed to address this question with respect to clinical outcome, side effects, and whether depression is a significant moderator with regard to treatment frequency. In addition, in an exploratory manner pain scores will be recorded to determine if either frequency has an impact on subjective sense of global pain
11195472|NCT02158663|OG001|Outcome|Right Fast Prefrontal rTMS|This study is designed to address this question with respect to clinical outcome, side effects, and whether depression is a significant moderator with regard to treatment frequency. In addition, in an exploratory manner pain scores will be recorded to determine if either frequency has an impact on subjective sense of global pain.
11195473|NCT02158663|EG000|Reported Event|Right Slow Prefrontal rTMS|"Repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation: TMS Device"
11195474|NCT02158663|EG001|Reported Event|Right Fast Prefrontal rTMS|"Repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation: TMS Device"
11195475|NCT02158728|BG000|Baseline|ICD Indicated Subjects|Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-Invasive ElectroPhysiology Study [NIPS]).
11195476|NCT02158728|FG000|Participant Flow|ICD Indicated Subjects|"Subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-invasive EP study [NIPS])~ICD: implantable cardioverter defibrillator CRT-D: cardiac resynchronization therapy defibrillator"
11195477|NCT02158728|OG000|Outcome|ICD Indicated Subjects|From the initially 80 enrolled subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or EP study (including Non-invasive EP Study [NIPS]), 53 subjects provided SVT episode data which qualified for developing and testing new sensing and detection algorithms for a new MedtronicICD. SVT episodes with a ventricular response rate of ≥170 BPM are required in the development of the algorithms.
11195478|NCT02158728|EG000|Reported Event|ICD Indicated Subjects|Only ICD-indicated subjects undergoing standard ICD/CRT-D implant, ICD/CRT-D change-out, ablation, electrophysiology (EP) study or Non Invasive Programmed Stimulation (NIPS), and who provided a dataset which qualified for developing and testing the sensing and detection algorithms of the new ICD, are included in the analyses.
11195479|NCT02158806|BG000|Baseline|Aspirin|"150 mg capsule once daily for up to 24 weeks~Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks"
11195480|NCT02158806|BG001|Baseline|Placebo|"Matching inert capsule once daily for up to 24 weeks~Placebo: Matching placebo capsule containing inert bulking agent"
11195481|NCT02158806|BG002|Baseline|Total|Total of all reporting groups
11195482|NCT02158806|FG000|Participant Flow|Aspirin|"150 mg capsule once daily for up to 24 weeks~Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks"
11195483|NCT02158806|FG001|Participant Flow|Placebo|"Matching inert capsule once daily for up to 24 weeks~Placebo: Matching placebo capsule containing inert bulking agent"
11195484|NCT02158806|OG000|Outcome|Aspirin|"150 mg capsule once daily for up to 24 weeks~Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks"
11195485|NCT02158806|OG001|Outcome|Placebo|"Matching inert capsule once daily for up to 24 weeks~Placebo: Matching placebo capsule containing inert bulking agent"
11195486|NCT02158806|EG000|Reported Event|Aspirin|"150 mg capsule once daily for up to 24 weeks~Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks"
11195487|NCT02158806|EG001|Reported Event|Placebo|"Matching inert capsule once daily for up to 24 weeks~Placebo: Matching placebo capsule containing inert bulking agent"
11195488|NCT02158884|BG000|Baseline|IDEO Brace|"IDEO brace~IDEO brace: All participants will receive the IDEO brace and a 4 week integrated Return to Run physical therapy program."
11195489|NCT02158884|FG000|Participant Flow|IDEO Brace|"IDEO brace~IDEO brace: All participants will receive the IDEO brace and a 4 week integrated Return to Run physical therapy program."
11195490|NCT02158884|OG000|Outcome|IDEO Brace|"IDEO brace~IDEO brace: All participants will receive the IDEO brace."
11195491|NCT02158884|OG000|Outcome|IDEO Brace|"IDEO brace~IDEO brace: All participants will receive the IDEO brace and a 4 week integrated Return to Run physical therapy program."
11195492|NCT02158884|EG000|Reported Event|IDEO Brace|"IDEO brace~IDEO brace: All participants will receive the IDEO brace and a 4 week integrated Return to Run physical therapy program."
11195493|NCT02158936|BG000|Baseline|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
11241189|NCT02485158|OG003|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11195494|NCT02158936|BG001|Baseline|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
11195495|NCT02158936|BG002|Baseline|Total|Total of all reporting groups
11383254|NCT02457559|EG001|Reported Event|Tirabrutinib 80 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.
11383255|NCT02457559|EG002|Reported Event|Tirabrutinib 160 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383256|NCT02457559|EG003|Reported Event|Tirabrutinib 320 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11383257|NCT02457559|EG004|Reported Event|Tirabrutinib 400 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
11383258|NCT02457559|EG005|Reported Event|Tirabrutinib 500 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
11383259|NCT02457559|EG006|Reported Event|Tirabrutinib 600 mg QD (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383260|NCT02457559|EG007|Reported Event|Tirabrutinib 300 mg BID (CLL)|Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily (BID) for up to 96 months from first dose in the parent study.
11383261|NCT02457559|EG008|Reported Event|Tirabrutinib 160 mg QD (NHL)|Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
11383262|NCT02457559|EG009|Reported Event|Tirabrutinib 320 mg QD (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
11195496|NCT02158936|FG000|Participant Flow|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
11383263|NCT02457559|EG010|Reported Event|Tirabrutinib 480 mg QD (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
11383264|NCT02457559|EG011|Reported Event|Tirabrutinib 600 mg QD (NHL)|Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
11383265|NCT02442349|BG000|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
11383266|NCT02442349|FG000|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
11383267|NCT02442349|OG000|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
11383268|NCT02442349|EG000|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
11383269|NCT02417974|BG000|Baseline|Fecal Microbiota Transplant (FMT)|"Fecal Microbiota Transplant (FMT) via colonoscopy~Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)"
11383270|NCT02417974|BG001|Baseline|Control|No Fecal Microbiota Transplant (FMT) via colonoscopy
11383271|NCT02417974|BG002|Baseline|Total|Total of all reporting groups
11383272|NCT02417974|FG000|Participant Flow|Fecal Microbiota Transplant (FMT)|"Fecal Microbiota Transplant (FMT) via colonoscopy~Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)"
11383273|NCT02417974|FG001|Participant Flow|Control|No Fecal Microbiota Transplant (FMT) via colonoscopy
11383274|NCT02417974|OG000|Outcome|Fecal Microbiota Transplant (FMT)|"Fecal Microbiota Transplant (FMT) via colonoscopy~Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)"
11383275|NCT02417974|OG001|Outcome|Control|No Fecal Microbiota Transplant (FMT) via colonoscopy
11383276|NCT02417974|EG000|Reported Event|Fecal Microbiota Transplant (FMT)|"Fecal Microbiota Transplant (FMT) via colonoscopy~Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)"
11383277|NCT02417974|EG001|Reported Event|Control|No Fecal Microbiota Transplant (FMT) via colonoscopy
11383278|NCT02381652|BG000|Baseline|Cingal/Cingal|"Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383279|NCT02381652|BG001|Baseline|Cingal/Monovisc|"Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383280|NCT02381652|BG002|Baseline|Cingal/Saline|"Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383281|NCT02381652|BG003|Baseline|Total|Total of all reporting groups
11383282|NCT02381652|FG000|Participant Flow|Cingal/Cingal|"Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
10792354|NCT03666624|EG000|Reported Event|Personalized Care Network|"9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks~Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges."
10792355|NCT03666624|EG001|Reported Event|Routine Medical Care|No intervention
10792356|NCT03649217|BG000|Baseline|Wearing the iStride Device|"The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months~Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home."
10792357|NCT03649217|FG000|Participant Flow|Wearing the iStride Device|"The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months~Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home."
10792358|NCT03649217|OG000|Outcome|Wearing the iStride Device|"The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months~Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home."
10802672|NCT02347917|OG001|Outcome|MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)|"Participants orally received BBI608(480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10965765|NCT00883753|BG000|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
11195497|NCT02158936|FG001|Participant Flow|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
11195498|NCT02158936|OG000|Outcome|Eltrombopag|Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine
11195499|NCT02158936|OG001|Outcome|Placebo|Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine
11195500|NCT02158936|EG000|Reported Event|Eltrombopag|Eltrombopag
11195501|NCT02158936|EG001|Reported Event|Placebo|Placebo
11195502|NCT02158949|BG000|Baseline|mROAD|"1 week of twice daily text messages modeled after SBIRT interventions~mROAD"
11195503|NCT02158949|BG001|Baseline|Usual Care|Usual care in ED
11195504|NCT02158949|BG002|Baseline|Total|Total of all reporting groups
11195505|NCT02158949|FG000|Participant Flow|mROAD|"1 week of twice daily text messages modeled after SBIRT interventions~mROAD"
11195506|NCT02158949|FG001|Participant Flow|Usual Care|Usual care in ED
11195507|NCT02158949|OG000|Outcome|mROAD|"1 week of twice daily text messages modeled after SBIRT interventions~mROAD"
10792359|NCT03649217|EG000|Reported Event|Wearing the iStride Device|"The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months~Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home."
10792360|NCT03576976|BG000|Baseline|Clinic-based Cognitive Remediation|"Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792361|NCT03576976|BG001|Baseline|Hybrid Cognitive Remediation|"Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792362|NCT03576976|BG002|Baseline|Total|Total of all reporting groups
10792363|NCT03576976|FG000|Participant Flow|Clinic-based Cognitive Remediation|"Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792364|NCT03576976|FG001|Participant Flow|Hybrid Cognitive Remediation|"Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792365|NCT03576976|OG000|Outcome|Clinic-based Cognitive Remediation|"Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792366|NCT03576976|OG001|Outcome|Hybrid Cognitive Remediation|"Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792367|NCT03576976|EG000|Reported Event|Clinic-based Cognitive Remediation|"Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
10792368|NCT03576976|EG001|Reported Event|Hybrid Cognitive Remediation|"Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.~Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life."
11195508|NCT02158949|OG001|Outcome|Usual Care|Usual care in ED
10792369|NCT03569293|BG000|Baseline|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day for 16 weeks.
10792370|NCT03569293|BG001|Baseline|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.
10792371|NCT03569293|BG002|Baseline|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.
10792372|NCT03569293|BG003|Baseline|Adolescents: Placebo|Adolescent participants (12 - 17 years old) received placebo orally once a day for 16 weeks.
11195509|NCT02158949|EG000|Reported Event|mROAD|"1 week of twice daily text messages modeled after SBIRT interventions~mROAD"
11195510|NCT02158949|EG001|Reported Event|Usual Care|Usual care in ED
10792373|NCT03569293|BG004|Baseline|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
11195511|NCT02158975|BG000|Baseline|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
11195512|NCT02158975|FG000|Participant Flow|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
11195513|NCT02158975|OG000|Outcome|MLN9708|"MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.~MLN9708"
11195514|NCT02158975|OG000|Outcome|MLN9708|MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
11195515|NCT02158975|EG000|Reported Event|MLN9708|MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
10792374|NCT03569293|BG005|Baseline|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
10792375|NCT03569293|BG006|Baseline|Total|Total of all reporting groups
10792376|NCT03569293|FG000|Participant Flow|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day (QD) for 16 weeks.
10792377|NCT03569293|FG001|Participant Flow|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.
10792378|NCT03569293|FG002|Participant Flow|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.
10792379|NCT03569293|FG003|Participant Flow|Adolescents: Placebo|Adolescent participants (12 - 17 years old) received placebo orally once a day for 16 weeks.
10792380|NCT03569293|FG004|Participant Flow|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
10792381|NCT03569293|FG005|Participant Flow|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
10792382|NCT03569293|OG000|Outcome|Placebo|Participants received placebo orally once a day for 16 weeks.
10792383|NCT03569293|OG001|Outcome|Upadacitinib 15 mg QD|Participants received upadacitinib 15 mg orally once daily for 16 weeks.
10792384|NCT03569293|OG002|Outcome|Upadacitinib 30 mg QD|Participants received upadacitinib 30 mg orally once daily for 16 weeks.
10792385|NCT03569293|OG000|Outcome|Adolescents: Placebo|Adolescent participants received placebo orally once a day for 16 weeks.
10792386|NCT03569293|OG001|Outcome|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.
10792387|NCT03569293|OG002|Outcome|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.
10792388|NCT03569293|EG000|Reported Event|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day for 16 weeks.
11195516|NCT02159053|BG000|Baseline|Secukinumab 150 mg With Loading Dose|Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
10792389|NCT03569293|EG001|Reported Event|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once daily for 16 weeks.
10792390|NCT03569293|EG002|Reported Event|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once daily for 16 weeks.
10792391|NCT03569293|EG003|Reported Event|Adolescents: Placebo|Adolescent participants (12 - 17 years old) received placebo orally once a day (QD) for 16 weeks.
10792392|NCT03569293|EG004|Reported Event|Adolescents: Upadacitinib 15 mg QD|Adolescent participants (12 - 17 years old) received upadacitinib 15 mg orally once daily for 16 weeks.
10792393|NCT03569293|EG005|Reported Event|Adolescents: Upadacitinib 30 mg QD|Adolescent participants (12 - 17 years old) received upadacitinib 30 mg orally once daily for 16 weeks.
10792394|NCT03564353|BG000|Baseline|C2 Right|"memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation~tDCS: tDCS"
10792395|NCT03564353|BG001|Baseline|C2 Left|"memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation~tDCS: tDCS"
10792396|NCT03564353|BG002|Baseline|Trigeminal Nerve|"memory task paired with tDCS targeting the Trigeminal Nerve~tDCS: tDCS"
10792397|NCT03564353|BG003|Baseline|Cranial 5/6 Nerves|"memory task paired with tDCS targeting the fifth cranial nerve (C5)~tDCS: tDCS"
10792398|NCT03564353|BG004|Baseline|Total|Total of all reporting groups
10792399|NCT03564353|FG000|Participant Flow|C2 Right|"memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation~tDCS: tDCS"
10792400|NCT03564353|FG001|Participant Flow|C2 Left|"memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation~tDCS: tDCS"
10792401|NCT03564353|FG002|Participant Flow|Trigeminal Nerve|"memory task paired with tDCS targeting the Trigeminal Nerve~tDCS: tDCS"
10792402|NCT03564353|FG003|Participant Flow|Cranial 5/6 Nerves|"memory task paired with tDCS targeting the fifth cranial nerve (C5)~tDCS: tDCS"
10792403|NCT03564353|OG000|Outcome|C2 Right|"memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation~tDCS: tDCS"
10792404|NCT03564353|OG001|Outcome|C2 Left|"memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation~tDCS: tDCS"
10792405|NCT03564353|OG002|Outcome|Trigeminal Nerve|"memory task paired with tDCS targeting the Trigeminal Nerve~tDCS: tDCS"
10792406|NCT03564353|OG003|Outcome|Cranial 5/6 Nerves|"memory task paired with tDCS targeting the fifth cranial nerve (C5)~tDCS: tDCS"
10792407|NCT03564353|EG000|Reported Event|Memory Task With tDCS Location 1|"memory task paired with tDCS targeting location 1~tDCS: tDCS"
10792408|NCT03564353|EG001|Reported Event|Memory Task With tDCS Location 2|"memory task paired with tDCS targeting location 2~tDCS: tDCS"
10792409|NCT03564353|EG002|Reported Event|Memory Task With tDCS Location 3|"memory task paired with tDCS targeting location 3~tDCS: tDCS"
10792410|NCT03564353|EG003|Reported Event|Memory Task With tDCS Location 4|"memory task paired with tDCS targeting location 4~tDCS: tDCS"
10792411|NCT03541499|BG000|Baseline|BPZE1 10^7 CFU by VaxINator|800 microliters (10^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792412|NCT03541499|BG001|Baseline|BPZE1 10^9 CFU by VaxINator|800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792413|NCT03541499|BG002|Baseline|BPZE1 10^9 CFU by Syringe|800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
10792414|NCT03541499|BG003|Baseline|Placebo by VaxINator|800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
10792415|NCT03541499|BG004|Baseline|Total|Total of all reporting groups
10792416|NCT03541499|FG000|Participant Flow|BPZE1 10^7 CFU by VaxINator|"800 microliters (10^7 CFU) of B. pertussis vaccine (BPZE1) administered intranasally with the VaxINator device on Day 1.~BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10^7 colony forming units (CFU)."
11195517|NCT02159053|BG001|Baseline|Secukinumab 150 mg Without Loading Dose|Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.
10792417|NCT03541499|FG001|Participant Flow|BPZE1 10^9 CFU by VaxINator|"800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.~BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10^9 colony forming units (CFU)."
10792418|NCT03541499|FG002|Participant Flow|BPZE1 10^9 CFU by Syringe|"800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.~BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10^9 colony forming units (CFU) ."
10792419|NCT03541499|FG003|Participant Flow|Placebo by VaxINator|"800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.~Placebo: The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI)."
10792420|NCT03541499|OG000|Outcome|BPZE1 10^7 CFU by VaxINator|800 microliters (10^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792421|NCT03541499|OG001|Outcome|BPZE1 10^9 CFU by VaxINator|800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792422|NCT03541499|OG002|Outcome|BPZE1 10^9 CFU by Syringe|800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
10792423|NCT03541499|OG003|Outcome|Placebo by VaxINator|800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
11195518|NCT02159053|BG002|Baseline|Placebo|Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
10792424|NCT03541499|EG000|Reported Event|BPZE1 10^7 CFU by VaxINator|800 microliters (10^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792425|NCT03541499|EG001|Reported Event|BPZE1 10^9 CFU by VaxINator|800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
10792426|NCT03541499|EG002|Reported Event|BPZE1 10^9 CFU by Syringe|800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
10792427|NCT03541499|EG003|Reported Event|Placebo by VaxINator|800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
10792428|NCT03473977|BG000|Baseline|Benralizumab|Subcutaneous dose of 30 mg of Benralizumab every 4 weeks (total of 3 doses)
10792429|NCT03473977|BG001|Baseline|Placebo|Subcutaneous dose of Placebo every 4 weeks (total of 3 doses)
10792430|NCT03473977|BG002|Baseline|Total|Total of all reporting groups
10792431|NCT03473977|FG000|Participant Flow|Benralizumab|"Subcutaneous dose of 30 mg of Benralizumab every 4 weeks~Benralizumab: Benralizumab (anti-IL5Ra) will be injected in doses of 30 mg every 4 weeks (3 times) in subjects with active Eosinophilic Gastritis."
10792432|NCT03473977|FG001|Participant Flow|Placebo|"Subcutaneous dose of Placebo every 4 weeks~Placebo: Placebo will be injected every 4 weeks (3 times) as a comparator to Benralizumab in subjects with active Eosinophilic Gastritis."
10792433|NCT03473977|OG000|Outcome|Benralizumab|Subcutaneous dose of 30 mg of Benralizumab every 4 weeks (total of 3 injections)
10792434|NCT03473977|OG001|Outcome|Placebo|Subcutaneous dose of Placebo every 4 weeks (total of 3 injections)
10792435|NCT03473977|EG000|Reported Event|Benralizumab|Subcutaneous dose of 30 mg of Benralizumab every 4 weeks (total of 3 doses)
10792436|NCT03473977|EG001|Reported Event|Placebo|Subcutaneous dose of Placebo every 4 weeks (total of 3 doses)
10792437|NCT03373110|BG000|Baseline|Online Mindfulness Based Cognitive Therapy +Fitbit|"A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.~Online Mindfulness Based Cognitive Therapy: see arm description"
10792438|NCT03373110|BG001|Baseline|Online Cognitive Behavioral Therapy +Fitbit|"1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.~Online Cognitive Behavioral Therapy: see arm description"
10792439|NCT03373110|BG002|Baseline|Fitbit Alone|"Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.~Fitbit Alone: see arm description"
10792440|NCT03373110|BG003|Baseline|Total|Total of all reporting groups
10792441|NCT03373110|FG000|Participant Flow|Online Mindfulness Based Cognitive Therapy +Fitbit|"A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.~Online Mindfulness Based Cognitive Therapy: see arm description"
10792442|NCT03373110|FG001|Participant Flow|Online Cognitive Behavioral Therapy +Fitbit|"1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.~Online Cognitive Behavioral Therapy: see arm description"
11195519|NCT02159053|BG003|Baseline|Total|Total of all reporting groups
10792443|NCT03373110|FG002|Participant Flow|Fitbit Alone|"Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.~Fitbit Alone: see arm description"
10792444|NCT03373110|OG000|Outcome|Online Mindfulness Based Cognitive Therapy +Fitbit|"A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.~Online Mindfulness Based Cognitive Therapy: see arm description"
10792445|NCT03373110|OG001|Outcome|Online Cognitive Behavioral Therapy +Fitbit|"1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.~Online Cognitive Behavioral Therapy: see arm description"
10792446|NCT03373110|OG002|Outcome|Fitbit Alone|"Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.~Fitbit Alone: see arm description"
10792447|NCT03373110|EG000|Reported Event|Online Mindfulness Based Cognitive Therapy +Fitbit|"A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.~Online Mindfulness Based Cognitive Therapy: see arm description"
10792448|NCT03373110|EG001|Reported Event|Online Cognitive Behavioral Therapy +Fitbit|"1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.~Online Cognitive Behavioral Therapy: see arm description"
10792449|NCT03373110|EG002|Reported Event|Fitbit Alone|"Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.~Fitbit Alone: see arm description"
10792450|NCT03365102|BG000|Baseline|Anodal tDCS Over the rIFG,|"anodal tDCS over the rIFG,~anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792451|NCT03365102|BG001|Baseline|Anodal tDCS Over the lOFC|"anodal tDCS over the lOFC~anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792452|NCT03365102|BG002|Baseline|Sham tDCS Stimulation|"sham tDCS stimulation~sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792453|NCT03365102|BG003|Baseline|Total|Total of all reporting groups
10792454|NCT03365102|FG000|Participant Flow|Anodal tDCS Over the rIFG,|"anodal tDCS over the rIFG,~anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
11195520|NCT02159053|FG000|Participant Flow|Secukinumab 150 mg With Loading Dose|Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
11195521|NCT02159053|FG001|Participant Flow|Secukinumab 150 mg Without Loading Dose|Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.
11195522|NCT02159053|FG002|Participant Flow|Placebo|Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
11195523|NCT02159053|OG000|Outcome|Secukinumab 150 mg With Loading Dose|Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
10792455|NCT03365102|FG001|Participant Flow|Anodal tDCS Over the lOFC|"anodal tDCS over the lOFC~anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792456|NCT03365102|FG002|Participant Flow|Sham tDCS Stimulation|"sham tDCS stimulation~sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792457|NCT03365102|OG000|Outcome|Anodal tDCS Over the rIFG,|"anodal tDCS over the rIFG,~anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792458|NCT03365102|OG001|Outcome|Anodal tDCS Over the lOFC|"anodal tDCS over the lOFC~anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
11195524|NCT02159053|OG001|Outcome|Secukinumab 150 mg Without Loading Dose|Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.
11195525|NCT02159053|OG002|Outcome|Placebo|Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
10802673|NCT02347917|OG000|Outcome|NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
11195526|NCT02159053|OG003|Outcome|All Secukinumab 150 mg Treated Participants|All participants who were s.c. administered with secukinumab during the study.
11195527|NCT02159053|EG000|Reported Event|Secukinumab 150 mg Without Loading Dose|Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.
11195528|NCT02159053|EG001|Reported Event|Secukinumab 150 mg With Loading|Participants were s.c. administered with 150 mg of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
11195529|NCT02159053|EG002|Reported Event|All Secukinumab 150 mg Treated Participants|All participants who were s.c. administered with secukinumab during the study.
11195530|NCT02159053|EG003|Reported Event|Placebo|Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
11195531|NCT02159079|BG000|Baseline|Usual Care|Patients in the usual care arm will be managed exclusively by their treating clinician without input from study personnel.
11195532|NCT02159079|BG001|Baseline|Conservative Fluid Management Strategy|For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.
11195533|NCT02159079|BG002|Baseline|Total|Total of all reporting groups
11195534|NCT02159079|FG000|Participant Flow|Usual Care|Patients in the usual care arm will be managed exclusively by their treating clinician without input from study personnel.
11195535|NCT02159079|FG001|Participant Flow|Conservative Fluid Management Strategy|For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.
11195536|NCT02159079|OG000|Outcome|Usual Care|Patients in the usual care arm will be managed exclusively by their treating clinician without input from study personnel.
11195537|NCT02159079|OG001|Outcome|Conservative Fluid Management Strategy|For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.
10792459|NCT03365102|OG002|Outcome|Sham tDCS Stimulation|"sham tDCS stimulation~sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792460|NCT03365102|EG000|Reported Event|Anodal tDCS Over the rIFG,|"anodal tDCS over the rIFG,~anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792461|NCT03365102|EG001|Reported Event|Anodal tDCS Over the lOFC|"anodal tDCS over the lOFC~anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792462|NCT03365102|EG002|Reported Event|Sham tDCS Stimulation|"sham tDCS stimulation~sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition."
10792463|NCT03318003|BG000|Baseline|Auto-PAP Therapy|Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
10792464|NCT03318003|BG001|Baseline|No Therapy|No treatment
10792465|NCT03318003|BG002|Baseline|Total|Total of all reporting groups
10792466|NCT03318003|FG000|Participant Flow|Auto-PAP Therapy|Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
10792467|NCT03318003|FG001|Participant Flow|No Therapy|No treatment
10792468|NCT03318003|OG000|Outcome|Auto-PAP Therapy|Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
10792469|NCT03318003|OG001|Outcome|No Therapy|No treatment
10792470|NCT03318003|EG000|Reported Event|Auto-PAP Therapy|Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
10792471|NCT03318003|EG001|Reported Event|No Therapy|No treatment
11195538|NCT02159079|EG000|Reported Event|Usual Care|Patients in the usual care arm will be managed exclusively by their treating clinician without input from study personnel.
10792472|NCT03309072|BG000|Baseline|Active tDCS|"active tDCS with Face Name associate Memory task~tDCS: active tDCS"
10792473|NCT03309072|BG001|Baseline|Sham tDCS|"sham tDCS with Face Name associate Memory task~sham tDCS: sham tDCS"
10792474|NCT03309072|BG002|Baseline|Total|Total of all reporting groups
10792475|NCT03309072|FG000|Participant Flow|Active tDCS|"active tDCS with Face Name associate Memory task~tDCS: active tDCS"
10792476|NCT03309072|FG001|Participant Flow|Sham tDCS|"sham tDCS with Face Name associate Memory task~sham tDCS: sham tDCS"
10792477|NCT03309072|OG000|Outcome|Active tDCS|"active tDCS with Face Name associate Memory task~tDCS: active tDCS"
10792478|NCT03309072|OG001|Outcome|Sham tDCS|"sham tDCS with Face Name associate Memory task~sham tDCS: sham tDCS"
10792479|NCT03309072|EG000|Reported Event|Active tDCS|"active tDCS with Face Name associate Memory task~tDCS: active tDCS"
10792480|NCT03309072|EG001|Reported Event|Sham tDCS|"sham tDCS with Face Name associate Memory task~sham tDCS: sham tDCS"
10802674|NCT02347917|OG001|Outcome|MPM: BBI608 + Pem +CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802675|NCT02347917|OG002|Outcome|MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802676|NCT02347917|OG003|Outcome|MPM: BBI608 + Pem + CDDP (Phase 2 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802677|NCT02347917|OG004|Outcome|MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802678|NCT02347917|OG004|Outcome|MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10792481|NCT03138590|BG000|Baseline|Active tDCS|"Active transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792482|NCT03138590|BG001|Baseline|Sham tDCS|"Sham transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792483|NCT03138590|BG002|Baseline|Total|Total of all reporting groups
10792484|NCT03138590|FG000|Participant Flow|Active tDCS|"Active transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792485|NCT03138590|FG001|Participant Flow|Sham tDCS|"Sham transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792486|NCT03138590|OG000|Outcome|Active tDCS|"Active transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792487|NCT03138590|OG001|Outcome|Sham tDCS|"Sham transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792488|NCT03138590|EG000|Reported Event|Active tDCS|"Active transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792489|NCT03138590|EG001|Reported Event|Sham tDCS|"Sham transcranial Direct Current Stimulation targeting the trigeminal nerve~Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve"
10792490|NCT03132753|BG000|Baseline|SUPPORT Group|"Subjects enrolled in the intervention.~SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion."
10792491|NCT03132753|BG001|Baseline|Standard Care Group|Subjects enrolled in standard services.
10792492|NCT03132753|BG002|Baseline|Total|Total of all reporting groups
10792493|NCT03132753|FG000|Participant Flow|SUPPORT Group|"Subjects enrolled in the intervention.~SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion."
10792494|NCT03132753|FG001|Participant Flow|Standard Care Group|Subjects enrolled in standard services.
10792495|NCT03132753|OG000|Outcome|SUPPORT Group|"Subjects enrolled in the intervention.~SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion."
10792496|NCT03132753|OG001|Outcome|Standard Care Group|Subjects enrolled in standard services.
10792497|NCT03132753|EG000|Reported Event|SUPPORT Group|"Subjects enrolled in the intervention.~SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion."
10792498|NCT03132753|EG001|Reported Event|Standard Care Group|Subjects enrolled in standard services.
10792499|NCT03085680|BG000|Baseline|Curcumin|"Participants will be given identical capsules containing curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~Curcumin: Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792500|NCT03085680|BG001|Baseline|Placebo|"Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~microcrystalline cellulose: Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792501|NCT03085680|BG002|Baseline|Total|Total of all reporting groups
10792502|NCT03085680|FG000|Participant Flow|Curcumin|"Participants will be given identical capsules containing curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~Curcumin: Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792503|NCT03085680|FG001|Participant Flow|Placebo|"Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~microcrystalline cellulose: Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792504|NCT03085680|OG000|Outcome|Curcumin|"Participants will be given identical capsules containing curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~Curcumin: Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792505|NCT03085680|OG001|Outcome|Placebo|"Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~microcrystalline cellulose: Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792506|NCT03085680|EG000|Reported Event|Curcumin|"Participants will be given identical capsules containing curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~Curcumin: Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792507|NCT03085680|EG001|Reported Event|Placebo|"Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.~microcrystalline cellulose: Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits."
10792508|NCT03067077|BG000|Baseline|All Participants|Participants receive SMILE surgery in one eye and Wavefront-guided LASIK in the fellow eye.
10792509|NCT03067077|FG000|Participant Flow|SMILE|SMILE surgery
10792510|NCT03067077|FG001|Participant Flow|Wavefront-guided LASIK|Wavefront-guided LASIK
10792511|NCT03067077|OG000|Outcome|SMILE|SMILE surgery
10792512|NCT03067077|OG001|Outcome|Wavefront-guided LASIK|Wavefront-guided LASIK
10792513|NCT03067077|EG000|Reported Event|SMILE|SMILE surgery
10792514|NCT03067077|EG001|Reported Event|Wavefront-guided LASIK|Wavefront-guided LASIK
10792515|NCT03059446|BG000|Baseline|Cenicriviroc (CVC) 150 mg|Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
10792516|NCT03059446|FG000|Participant Flow|Cenicriviroc (CVC) 150 mg|Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
10792517|NCT03059446|OG000|Outcome|Cenicriviroc (CVC) 150 mg|Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
10792518|NCT03059446|EG000|Reported Event|Cenicriviroc (CVC) 150 mg|Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
10792519|NCT03019575|BG000|Baseline|Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)|Participants received 100 μg (if body weight was ≤60 kg) or 150 μg (if body weight was >60 kg) of CFA as a subcutaneous (SC) injection once every 2 weeks for 64 Weeks (Day 1, Week 0 through Week 64) and 500-5000 IU of hCG reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64). The total treatment duration was 64 Weeks.
10792520|NCT03019575|FG000|Participant Flow|Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)|Participants received 100 μg (if body weight was ≤60 kg) or 150 μg (if body weight was >60 kg) of CFA as a subcutaneous (SC) injection once every 2 weeks for 64 Weeks (Day 1, Week 0 through Week 64) and 500-5000 IU of hCG reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64). The total treatment duration was 64 Weeks.
10792521|NCT03019575|OG000|Outcome|Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)|Participants received 100 μg (if body weight was ≤60 kg) or 150 μg (if body weight was >60 kg) of CFA as a subcutaneous (SC) injection once every 2 weeks for 64 Weeks (Day 1, Week 0 through Week 64) and 500-5000 IU of hCG reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64). The total treatment duration was 64 Weeks.
10792522|NCT03019575|EG000|Reported Event|Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)|Participants received 100 μg (if body weight was ≤60 kg) or 150 μg (if body weight was >60 kg) of CFA as a subcutaneous (SC) injection once every 2 weeks for 64 Weeks (Day 1, Week 0 through Week 64) and 500-5000 IU of hCG reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64). The total treatment duration was 64 Weeks.
10792523|NCT03011034|BG000|Baseline|Talacotuzumab|Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).
10792524|NCT03011034|BG001|Baseline|Daratumumab|Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
10792525|NCT03011034|BG002|Baseline|Total|Total of all reporting groups
10792526|NCT03011034|FG000|Participant Flow|Talacotuzumab|Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).
10792527|NCT03011034|FG001|Participant Flow|Daratumumab|Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
10792528|NCT03011034|OG000|Outcome|Talacotuzumab|Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).
10792529|NCT03011034|OG001|Outcome|Daratumumab|Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
11241190|NCT02485158|OG004|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
10792530|NCT03011034|EG000|Reported Event|Talacotuzumab|Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).
10792531|NCT03011034|EG001|Reported Event|Daratumumab|Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
10792532|NCT02980666|BG000|Baseline|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.
10792533|NCT02980666|BG001|Baseline|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.
10792534|NCT02980666|BG002|Baseline|Total|Total of all reporting groups
10792535|NCT02980666|FG000|Participant Flow|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.
10792536|NCT02980666|FG001|Participant Flow|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.
10792537|NCT02980666|OG000|Outcome|Total Children (Aged: 1 to 15 Years)|Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.
10792538|NCT02980666|OG001|Outcome|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.
10792539|NCT02980666|EG000|Reported Event|Total Children (Aged: 1 - 15 Years)|Participants aged from 1 through 15 years received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.
10792540|NCT02980666|EG001|Reported Event|Infants (Corrected Gestational Age: 4 to < 12 Months)|Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.
10792541|NCT02962102|BG000|Baseline|Calcifediol|"Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4~Calcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4"
10792542|NCT02962102|BG001|Baseline|Calcitriol|"Calcitriol 4mcg orally daily x 5 days~Calcitriol: Calcitriol 4mcg orally daily x 5"
10792543|NCT02962102|BG002|Baseline|Placebo|"Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days~Placebos: Placebo (medium chain triglyceride oil) orally daily x 5"
10792544|NCT02962102|BG003|Baseline|Total|Total of all reporting groups
10792545|NCT02962102|FG000|Participant Flow|Calcifediol|"Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4~Calcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4"
10792546|NCT02962102|FG001|Participant Flow|Calcitriol|"Calcitriol 4mcg orally daily x 5 days~Calcitriol: Calcitriol 4mcg orally daily x 5"
10792547|NCT02962102|FG002|Participant Flow|Placebo|"Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days~Placebos: Placebo (medium chain triglyceride oil) orally daily x 5"
10792548|NCT02962102|OG000|Outcome|Calcifediol|"Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4~Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4"
10792549|NCT02962102|OG001|Outcome|Calcitriol|"Calcitriol 4mcg PO/NGT/OGT daily x 5 days~Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5"
10792550|NCT02962102|OG002|Outcome|Placebo|"Equal volume of medium chain triglyceride (MCT) oil daily x 5 days~Placebos: Placebo (medium chain triglyceride oil) daily x 5"
10792551|NCT02962102|EG000|Reported Event|Calcifediol|"Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4~Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4"
10792552|NCT02962102|EG001|Reported Event|Calcitriol|"Calcitriol 4mcg PO/NGT/OGT daily x 5 days~Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5"
10792553|NCT02962102|EG002|Reported Event|Placebo|"Equal volume of medium chain triglyceride (MCT) oil daily x 5 days~Placebos: Placebo (medium chain triglyceride oil) daily x 5"
10792554|NCT02853331|BG000|Baseline|Pembrolizumab + Axitinib|Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
10792555|NCT02853331|BG001|Baseline|Sunitinib|Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
10792556|NCT02853331|BG002|Baseline|Total|Total of all reporting groups
10792557|NCT02853331|FG000|Participant Flow|Pembrolizumab + Axitinib|Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
10792558|NCT02853331|FG001|Participant Flow|Sunitinib|Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
10792559|NCT02853331|OG000|Outcome|Pembrolizumab + Axitinib|Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
10792560|NCT02853331|OG001|Outcome|Sunitinib|Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
10792561|NCT02853331|EG000|Reported Event|Pembrolizumab + Axitinib|Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
10792562|NCT02853331|EG001|Reported Event|Sunitinib|Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
10792563|NCT02841644|BG000|Baseline|Traumatic Arthrotomy- Treated Nonoperatively|"Patient diagnosed with traumatic arthrotomy treated nonoperatively.~Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy."
10792564|NCT02841644|BG001|Baseline|Traumatic Arthrotomy- Treated Operatively|"Patient diagnosed with traumatic arthrotomy treated operatively.~Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy."
10792565|NCT02841644|BG002|Baseline|Total|Total of all reporting groups
10792566|NCT02841644|FG000|Participant Flow|Traumatic Arthrotomy- Treated Nonoperatively|"Patient diagnosed with traumatic arthrotomy treated nonoperatively.~Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy."
10792567|NCT02841644|FG001|Participant Flow|Traumatic Arthrotomy- Treated Operatively|"Patient diagnosed with traumatic arthrotomy treated operatively.~Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy."
10792568|NCT02841644|OG000|Outcome|Traumatic Arthrotomy- Treated Nonoperatively|"Patient diagnosed with traumatic arthrotomy treated nonoperatively.~Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy."
10792569|NCT02841644|OG001|Outcome|Traumatic Arthrotomy- Treated Operatively|"Patient diagnosed with traumatic arthrotomy treated operatively.~Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy."
10792570|NCT02841644|EG000|Reported Event|Traumatic Arthrotomy- Treated Nonoperatively|"Patient diagnosed with traumatic arthrotomy treated nonoperatively.~Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy."
10792571|NCT02841644|EG001|Reported Event|Traumatic Arthrotomy- Treated Operatively|"Patient diagnosed with traumatic arthrotomy treated operatively.~Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy."
10792572|NCT02749045|BG000|Baseline|Image Acquisition Arm|"Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.~SPECT imaging: myocardial perfusion imaging"
10792573|NCT02749045|FG000|Participant Flow|Image Acquisition Arm|"Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.~SPECT imaging: myocardial perfusion imaging"
10792574|NCT02749045|OG000|Outcome|Image Acquisition Arm|"Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.~SPECT imaging: myocardial perfusion imaging"
10792575|NCT02749045|EG000|Reported Event|Image Acquisition Arm|"Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.~SPECT imaging: myocardial perfusion imaging"
10792576|NCT02659605|BG000|Baseline|Delayed Cord Clamping Above the Perineum|Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
10792577|NCT02659605|BG001|Baseline|Delayed Cord Clamping Below the Perineum|Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
10792578|NCT02659605|BG002|Baseline|Total|Total of all reporting groups
10792579|NCT02659605|FG000|Participant Flow|Delayed Cord Clamping Above the Perineum|Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
10792580|NCT02659605|FG001|Participant Flow|Delayed Cord Clamping Below the Perineum|Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
10792581|NCT02659605|OG000|Outcome|Delayed Cord Clamping Above the Perineum|Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
10792582|NCT02659605|OG001|Outcome|Delayed Cord Clamping Below the Perineum|Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
10792583|NCT02659605|EG000|Reported Event|Delayed Cord Clamping Above the Perineum|Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
10792584|NCT02659605|EG001|Reported Event|Delayed Cord Clamping Below the Perineum|Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
10792585|NCT02601014|BG000|Baseline|Nivolumab and Ipilimumab|"Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV"
10792586|NCT02601014|BG001|Baseline|Enzalutamide Plus Nivolumab and Ipilimumab|"Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV~Enzalutamide: given orally per standard of care"
10792587|NCT02601014|BG002|Baseline|Total|Total of all reporting groups
10792588|NCT02601014|FG000|Participant Flow|Nivolumab and Ipilimumab|"Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV"
10792589|NCT02601014|FG001|Participant Flow|Enzalutamide Plus Nivolumab and Ipilimumab|"Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV~Enzalutamide: given orally per standard of care"
10792590|NCT02601014|OG000|Outcome|Nivolumab and Ipilimumab|"Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV"
11195539|NCT02159079|EG001|Reported Event|Conservative Fluid Management Strategy|For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.
10792591|NCT02601014|OG001|Outcome|Enzalutamide Plus Nivolumab and Ipilimumab|"Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV~Enzalutamide: given orally per standard of care"
10792592|NCT02601014|EG000|Reported Event|Nivolumab and Ipilimumab|"Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV"
10792593|NCT02601014|EG001|Reported Event|Enzalutamide Plus Nivolumab and Ipilimumab|"Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab: Given 1 mg/kg IV~Nivolumab: Given 3 mg/kg IV~Enzalutamide: given orally per standard of care"
10792594|NCT02579096|BG000|Baseline|Allopurinol / Sham Comparator (Febuxostat)|"Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling febuxostat will be given with allopurinol~allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (febuxostat-shaped): Placebo in the shape of febuxostat will be given with allopurinol"
10792595|NCT02579096|BG001|Baseline|Febuxostat / Sham Comparator (Allopurinol)|"febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with febuxostat~febuxostat: febuxostat will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (allopurinol-shaped): Placebo in the shape of allopurinol will be given with febuxostat"
10792596|NCT02579096|BG002|Baseline|Total|Total of all reporting groups
10792597|NCT02579096|FG000|Participant Flow|Allopurinol / Sham Comparator (Febuxostat)|"Patients will be up-titrated up to the dose required to reach target uric acid levels.~Allopurinol: allopurinol capsule, 100-800 mg by mouth once daily~Placebo: tablets resembling febuxostat will be given with allopurinol."
10792598|NCT02579096|FG001|Participant Flow|Febuxostat / Sham Comparator (Allopurinol)|"Patients will be up-titrated to the dose required to reach target uric acid levels.~Febuxostat: tablet 40-120 mg by mouth once daily~Placebo: capsules resembling allopurinol will be given with febuxostat."
10792599|NCT02579096|OG000|Outcome|Allopurinol / Sham Comparator (Febuxostat)|"Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol~Allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (Febuxostat-shaped): Placebo in the shape of Febuxostat will be given with Allopurinol"
10792600|NCT02579096|OG001|Outcome|Febuxostat / Sham Comparator (Allopurinol)|"Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat~Febuxostat: Febuxostat will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (Allopurinol-shaped): Placebo in the shape of Allopurinol will be given with Febuxostat"
10792601|NCT02579096|EG000|Reported Event|Allopurinol / Sham Comparator (Febuxostat)|"Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol~Allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (Febuxostat-shaped): Placebo in the shape of Febuxostat will be given with Allopurinol"
10792602|NCT02579096|EG001|Reported Event|Febuxostat / Sham Comparator (Allopurinol)|"Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat~Febuxostat: Febuxostat will be titrated up to the dose that will lower to target uric acid levels.~Placebo, vehicle control (Allopurinol-shaped): Placebo in the shape of Allopurinol will be given with Febuxostat"
10792603|NCT02538666|BG000|Baseline|Placebo (Pbo)|Nivo pbo: 100 mL and Ipi pbo: 100 mL
10792604|NCT02538666|BG001|Baseline|Nivolumab|nivolumab 240mg Q2W IV infusion
10792605|NCT02538666|BG002|Baseline|Nivolumab + Ipilimumab|nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV Q3W for Four (4) doses followed by nivolumab 240mg Q2W
10792606|NCT02538666|BG003|Baseline|Total|Total of all reporting groups
10792607|NCT02538666|FG000|Participant Flow|Placebo (Pbo)|Nivo pbo: 100 mL and Ipi pbo: 100 mL
10792608|NCT02538666|FG001|Participant Flow|Nivolumab|nivolumab 240mg Q2W IV infusion
10792609|NCT02538666|FG002|Participant Flow|Nivolumab + Ipilimumab|nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV Q3W for Four (4) doses followed by nivolumab 240mg Q2W
10792610|NCT02538666|OG000|Outcome|Placebo|Nivo pbo: 100 mL and Ipi pbo: 100 mL
10792611|NCT02538666|OG001|Outcome|Nivolumab + Ipilimumab|nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV Q3W for Four (4) doses followed by nivolumab 240mg Q2W
10792612|NCT02538666|OG001|Outcome|Nivolumab|nivolumab 240mg Q2W IV infusion
10792613|NCT02538666|OG002|Outcome|Nivolumab + Ipilimumab|nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV Q3W for Four (4) doses followed by nivolumab 240mg Q2W
10792614|NCT02538666|EG000|Reported Event|Placebo|Nivo pbo: 100 mL and Ipi pbo: 100 mL
11195540|NCT02159118|BG000|Baseline|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
10792615|NCT02538666|EG001|Reported Event|Nivolumab 240 mg|nivolumab 240mg Q2W IV infusion
10792616|NCT02538666|EG002|Reported Event|Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg|nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV Q3W for Four (4) doses followed by nivolumab 240mg Q2W
10792617|NCT02527200|BG000|Baseline|Part A: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).
10792618|NCT02527200|BG001|Baseline|Part A: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792619|NCT02527200|BG002|Baseline|Part B: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792620|NCT02527200|BG003|Baseline|Part B: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792621|NCT02527200|BG004|Baseline|Total|Total of all reporting groups
10792622|NCT02527200|FG000|Participant Flow|Part A: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).
10792623|NCT02527200|FG001|Participant Flow|Part A: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10965766|NCT00883753|FG000|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
10792624|NCT02527200|FG002|Participant Flow|Part B: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792625|NCT02527200|FG003|Participant Flow|Part B: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792626|NCT02527200|OG000|Outcome|Part A: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).
10792627|NCT02527200|OG001|Outcome|Part A: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792628|NCT02527200|OG002|Outcome|Part B: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792629|NCT02527200|OG003|Outcome|Part B: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792630|NCT02527200|OG004|Outcome|Part A+B: Liraglutide|Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792631|NCT02527200|OG005|Outcome|Part A+B: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
10792632|NCT02527200|OG001|Outcome|Part B: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792633|NCT02527200|OG002|Outcome|Part A+B: Liraglutide|Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792634|NCT02527200|EG000|Reported Event|Part A: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).
10792635|NCT02527200|EG001|Reported Event|Part B: Liraglutide|Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
10792636|NCT02527200|EG002|Reported Event|Part A: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792637|NCT02527200|EG003|Reported Event|Part B: Placebo|Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
10792638|NCT02511106|BG000|Baseline|AZD9291|Taken once daily
10792639|NCT02511106|BG001|Baseline|Placebo|Taken once daily
10792640|NCT02511106|BG002|Baseline|Total|Total of all reporting groups
10792641|NCT02511106|FG000|Participant Flow|AZD9291|Taken once daily
10792642|NCT02511106|FG001|Participant Flow|Placebo|Taken once daily
10792643|NCT02511106|OG000|Outcome|AZD9291 80mg Tablet|Taken once daily
10792644|NCT02511106|OG001|Outcome|Placebo Tablet|Taken once daily
10792645|NCT02511106|OG000|Outcome|AZ5104|AZD9291 metabolite
10792646|NCT02511106|OG000|Outcome|AZ7550|AZD9291 metabolite
10792647|NCT02511106|EG000|Reported Event|AZD9291|Taken once daily
10792648|NCT02511106|EG001|Reported Event|Placebo|Taken once daily
10792649|NCT02477358|BG000|Baseline|PRF Treatment|"All study participants are scheduled for teeth extraction (between 2 to 6 teeth per participant). Subjects will be randomized to either receive either left tooth PRF; right tooth re-implantation, OR right tooth PRF; left tooth re implantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for at least 3 months (up to 11 months) and then tested for vitality before extracting and examining histologically.~All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically."
10792650|NCT02477358|BG001|Baseline|No Treatment|"All study participants are scheduled for teeth extraction (between 2 to 6 teeth per participant). Subjects will be randomized to either receive either left tooth PRF; right tooth re-implantation, OR right tooth PRF; left tooth re-implantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months (up to 11 months) and then tested for vitality before extracting and examining histologically.~All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will be re implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically."
10792651|NCT02477358|BG002|Baseline|Total|Total of all reporting groups
10792652|NCT02477358|FG000|Participant Flow|PRF Treatment|"All study participants are scheduled for teeth extraction. Subjects will be randomized to either receive either left tooth PRF; right tooth reimplantation, OR right tooth PRF; left tooth reimplantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.~All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically."
10792653|NCT02477358|FG001|Participant Flow|No Treatment|"All study participants are scheduled for teeth extraction. Subjects will be randomized to either receive either left tooth PRF; right tooth reimplantation, OR right tooth PRF; left tooth reimplantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.~All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically."
10792654|NCT02477358|OG000|Outcome|Experimental: PRF Treated|Teeth Extracted and reimplanted after PRF endodontic revascularization therapy. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
11195541|NCT02159118|BG001|Baseline|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195542|NCT02159118|BG002|Baseline|Total|Total of all reporting groups
11195543|NCT02159118|FG000|Participant Flow|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195544|NCT02159118|FG001|Participant Flow|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195545|NCT02159118|OG000|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195546|NCT02159118|OG001|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195547|NCT02159118|EG000|Reported Event|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195548|NCT02159118|EG001|Reported Event|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
11195549|NCT02159183|BG000|Baseline|Standard Plus ESTA STL Roxolid Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).~Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded."
11195550|NCT02159183|BG001|Baseline|Standard Plus STL Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.~Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded."
10792655|NCT02477358|OG001|Outcome|No Intervention: Control|Teeth Extracted and reimplanted. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
10792656|NCT02477358|OG000|Outcome|PRF Treated|"Subjects will be randomized to either receive either left tooth platelet rich fibrin; right tooth implant alone, OR right tooth platelet rich fibrin; left tooth implant alone. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.~Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone: All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy will be applied to the left tooth socket only. The right tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.~Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone: All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy to the right tooth socket only. The left tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically."
10792657|NCT02477358|OG001|Outcome|Control|Subjects will be randomized to either receive either left tooth platelet rich fibrin; right tooth implant alone, OR right tooth platelet rich fibrin; left tooth implant alone. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
10792658|NCT02477358|EG000|Reported Event|Experimental: PRF Treated|Teeth Extracted and reimplanted after PRF endodontic revascularization therapy. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
10792659|NCT02477358|EG001|Reported Event|No Intervention: Control|Teeth Extracted and reimplanted. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
10792660|NCT02432209|BG000|Baseline|Intensive Lifestyle Mod. Intervention|"The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.~Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.~Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792661|NCT02432209|BG001|Baseline|Standard Lifestyle Intervention|"Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792662|NCT02432209|BG002|Baseline|Total|Total of all reporting groups
10792663|NCT02432209|FG000|Participant Flow|Intensive Lifestyle Mod. Intervention|"The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.~Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.~Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792664|NCT02432209|FG001|Participant Flow|Standard Lifestyle Intervention|"Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792665|NCT02432209|OG000|Outcome|Intensive Lifestyle Mod. Intervention|"The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.~Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.~Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
11195551|NCT02159183|BG002|Baseline|Total|Total of all reporting groups
11241191|NCT02485158|OG005|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
10792666|NCT02432209|OG001|Outcome|Standard Lifestyle Intervention|"Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792667|NCT02432209|EG000|Reported Event|Intensive Lifestyle Mod. Intervention|"The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.~Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.~Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792668|NCT02432209|EG001|Reported Event|Standard Lifestyle Intervention|"Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.~Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day."
10792669|NCT02392637|BG000|Baseline|High Dosage|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle.
10792670|NCT02392637|BG001|Baseline|Low Dosage|Gemcitabine 800mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 100mg/m2 on days 1 & 8 of a 21 day cycle.
10792671|NCT02392637|BG002|Baseline|Total|Total of all reporting groups
10792672|NCT02392637|FG000|Participant Flow|High Dosage|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle.
10792673|NCT02392637|FG001|Participant Flow|Low Dosage|Gemcitabine 800mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 100mg/m2 on days 1 & 8 of a 21 day cycle.
10792674|NCT02392637|OG000|Outcome|High Dosage|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle
10792675|NCT02392637|OG001|Outcome|Low Dosage|Gemcitabine 800mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 100mg/m2 on days 1 & 8 of a 21 day cycle.
10792676|NCT02392637|OG000|Outcome|High Dose|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle
10792677|NCT02392637|OG001|Outcome|Low Dose|Gemcitabine 800mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 100mg/m2 on days 1 & 8 of a 21 day cycle.
10792678|NCT02392637|OG000|Outcome|High Dose|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle.
10792679|NCT02392637|EG000|Reported Event|High Dose|Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 125mg/m2 on days 1 & 8 of a 21 day cycle.
10792680|NCT02392637|EG001|Reported Event|Low Dose|Gemcitabine 800mg/m2, Cisplatin 25mg/m2 & Nab-Paclitaxel 100mg/m2 on days 1 & 8 of a 21 day cycle.
10802679|NCT02347917|EG000|Reported Event|MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802680|NCT02347917|EG001|Reported Event|MPM: BBI608 + Pem + CDDP (Phase 2 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802681|NCT02347917|EG002|Reported Event|MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)|"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.~Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days."
10802682|NCT02344108|BG000|Baseline|Inspire® Upper Airway Simulation System|Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, underwent surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator was activated one month after surgery and subjects underwent repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects were followed for one year to determine safety and efficacy of the device.
10802683|NCT02344108|FG000|Participant Flow|Inspire® Upper Airway Simulation System|Subjects meeting inclusion criteria, including sleep study and drug induced sleep endoscopy criteria, underwent surgical placement of a hypoglossal nerve simulator (Inspire® Upper Airway Simulation System Model 3028 IPG). The simulator was activated one month after surgery and subjects underwent repeat sleep study evaluation and device titration at one, two, six and twelve months after implantation. Subjects were followed for one year to determine safety and efficacy of the device.
11195552|NCT02159183|FG000|Participant Flow|Standard Plus ESTA STL Roxolid Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).~Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded."
10802684|NCT02344108|OG000|Outcome|Inspire® Upper Airway Simulation System|Following hypoglossal nerve stimulator implantation, participants returned for a 1-week postoperative follow-up visit with their pediatric otolaryngologist. Titration polysomnography was performed 1, 3, 6, and 12 months after implantation. Quality-of-life assessments were completed at baseline and 12 months postoperatively. Adverse events were queried at every scheduled postoperative visit.
10792681|NCT02253316|BG000|Baseline|Consolidation: Ixazomib, Lenalidomide, & Dexamethasone|Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, & dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 55 mg of lenalidomide will be administered on daily on Days 1-21.
10792682|NCT02253316|FG000|Participant Flow|Consolidation: Ixazomib, Lenalidomide, & Dexamethasone|Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, & dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 55 mg of lenalidomide will be administered on daily on Days 1-21.
10792683|NCT02253316|FG001|Participant Flow|Maintenance Arm 1: Ixazomib|"Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.~09/23/2019: Upon review of the interim analysis, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator."
10792684|NCT02253316|FG002|Participant Flow|Maintenance Arm 2: Lenalidomide|Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
10792685|NCT02253316|OG000|Outcome|Consolidation: Ixazomib, Lenalidomide, & Dexamethasone|Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, & dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 55 mg of lenalidomide will be administered on daily on Days 1-21.
10792686|NCT02253316|OG001|Outcome|Maintenance Arm 1: Ixazomib|"Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.~09/23/2019: Upon review of the interim analysis, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator."
11195553|NCT02159183|FG001|Participant Flow|Standard Plus STL Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.~Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded."
11195554|NCT02159183|OG000|Outcome|Standard Plus ESTA STL Roxolid Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).~Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded."
11195555|NCT02159183|OG001|Outcome|Standard Plus STL Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.~Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded."
11195556|NCT02159183|EG000|Reported Event|Standard Plus ESTA STL Roxolid Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).~Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded."
10792687|NCT02253316|OG002|Outcome|Maintenance Arm 2: Lenalidomide|Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
10792688|NCT02253316|EG000|Reported Event|Consolidation: Ixazomib, Lenalidomide, & Dexamethasone|Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, & dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 55 mg of lenalidomide will be administered on daily on Days 1-21.
11195557|NCT02159183|EG001|Reported Event|Standard Plus STL Implant|"This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.~Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded."
10792689|NCT02253316|EG001|Reported Event|Maintenance Arm 1: Ixazomib|Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.
11195558|NCT02159352|BG000|Baseline|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195559|NCT02159352|BG001|Baseline|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
11195560|NCT02159352|BG002|Baseline|Total|Total of all reporting groups
11195561|NCT02159352|FG000|Participant Flow|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195562|NCT02159352|FG001|Participant Flow|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
11195563|NCT02159352|OG000|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
11195564|NCT02159352|OG001|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195565|NCT02159352|OG002|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
11195566|NCT02159352|OG003|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
10792690|NCT02253316|EG002|Reported Event|Maintenance Arm 2: Lenalidomide|Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
10792691|NCT02224573|BG000|Baseline|Dravet Syndrome|Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792692|NCT02224573|BG001|Baseline|Lennox-Gastaut Syndrome|Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792693|NCT02224573|BG002|Baseline|Total|Total of all reporting groups
10792694|NCT02224573|FG000|Participant Flow|Dravet Syndrome|Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792695|NCT02224573|FG001|Participant Flow|Lennox-Gastaut Syndrome|Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792696|NCT02224573|OG000|Outcome|Dravet Syndrome|Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792697|NCT02224573|OG001|Outcome|Lennox-Gastaut Syndrome|Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
11195567|NCT02159352|OG000|Outcome|Daclatasvir (60 mg) Days 1-4|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
11195568|NCT02159352|OG001|Outcome|Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195569|NCT02159352|OG002|Outcome|Daclatasvir (60 mg) Days 5-14|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
11195570|NCT02159352|OG003|Outcome|Daclatasvir (30 mg) + Lopinavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
11195571|NCT02159352|OG001|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195572|NCT02159352|OG002|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
11195573|NCT02159352|OG003|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
11195574|NCT02159352|OG002|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
11195575|NCT02159352|OG003|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
11195576|NCT02159352|OG003|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 -mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
10792698|NCT02224573|OG000|Outcome|Lennox-Gastaut Syndrome|Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792699|NCT02224573|EG000|Reported Event|Dravet Syndrome|Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], and GWEP1424 [NCT02224703]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792700|NCT02224573|EG001|Reported Event|Lennox-Gastaut Syndrome|Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 [NCT02224560] and GWEP1423 [NCT02224690]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
10792701|NCT01991067|BG000|Baseline|HSCT Patients / TBE Virus Vaccine|"Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792702|NCT01991067|BG001|Baseline|Healthy Volunteers / TBE Virus Vaccine|"Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792703|NCT01991067|BG002|Baseline|Total|Total of all reporting groups
10792704|NCT01991067|FG000|Participant Flow|HSCT Patients / TBE Virus Vaccine|"Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792705|NCT01991067|FG001|Participant Flow|Healthy Volunteers / TBE Virus Vaccine|"Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792706|NCT01991067|OG000|Outcome|HSCT Patients / TBE Virus Vaccine|"Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792707|NCT01991067|OG001|Outcome|Healthy Volunteers / TBE Virus Vaccine|"Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792708|NCT01991067|EG000|Reported Event|HSCT Patients / TBE Virus Vaccine|"Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10792709|NCT01991067|EG001|Reported Event|Healthy Volunteers / TBE Virus Vaccine|"Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination).~TBE virus vaccine: TBE virus vaccine FSME Immun is used in both arms for the study population and the control group"
10802685|NCT02344108|OG000|Outcome|Inspire® Upper Airway Simulation System|Following hypoglossal nerve stimulator implantation, participants returned for follow-up study visits 1 week, 1 month, 2 months, 6 months, and 12 months postoperatively. Adverse events were queried from the time of enrollment to the time of completing the 12 month visit.
10802686|NCT02344108|OG000|Outcome|Inspire® Upper Airway Simulation System|Following hypoglossal nerve stimulator implantation, participants returned for a 1-week postoperative follow-up visit with their pediatric otolaryngologist. Titration polysomnography was performed 1, 3, 6, and 12 months after implantation. Quality-of-life assessments were completed at baseline and 12 months postoperatively.
10792710|NCT01928732|BG000|Baseline|Behavioral: Prolonged Exposure (PE)|"PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."
10792711|NCT01928732|BG001|Baseline|Behavioral: Cognitive Processing Therapy (CPT)|CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
10792712|NCT01928732|BG002|Baseline|Total|Total of all reporting groups
10792713|NCT01928732|FG000|Participant Flow|Behavioral: Prolonged Exposure (PE)|"PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."
10792714|NCT01928732|FG001|Participant Flow|Behavioral: Cognitive Processing Therapy (CPT)|CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
10792715|NCT01928732|OG000|Outcome|Behavioral: Prolonged Exposure (PE)|"PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."
10792716|NCT01928732|OG001|Outcome|Behavioral: Cognitive Processing Therapy (CPT)|CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
10792717|NCT01928732|EG000|Reported Event|Behavioral: Prolonged Exposure (PE)|"Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."
11195577|NCT02159352|OG000|Outcome|Group 1: Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
11195578|NCT02159352|OG001|Outcome|Group 2: Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
11195579|NCT02159352|OG001|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14.
11195580|NCT02159352|EG000|Reported Event|Group 1: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and 30 mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
10792718|NCT01928732|EG001|Reported Event|Behavioral: Cognitive Processing Therapy (CPT)|Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
10792719|NCT01925573|BG000|Baseline|Optune+RT+Bevacuzimab|"Part 1:~Bevacizumab every 2 weeks plus Optune daily for 4 week cycles.~Part 2:~RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice.~Part 3:~Adjuvant Bevacizumab and Optune~Optune(NOVOTTF-100A)"
10792720|NCT01925573|FG000|Participant Flow|Optune+RT+Bevacuzimab|"Part 1:~Bevacizumab every 2 weeks plus Optune daily for 4 week cycles.~Part 2:~RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice.~Part 3:~Adjuvant Bevacizumab and Optune~Optune(NOVOTTF-100A)"
10792721|NCT01925573|OG000|Outcome|Optune+RT+Bevacuzimab|"Part 1:~Bevacizumab every 2 weeks plus Optune daily for 4 week cycles.~Part 2:~RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice.~Part 3:~Adjuvant Bevacizumab and Optune~Optune(NOVOTTF-100A)"
10792722|NCT01925573|EG000|Reported Event|Optune+RT+Bevacuzimab|"Part 1:~Bevacizumab every 2 weeks plus Optune daily for 4 week cycles.~Part 2:~RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice.~Part 3:~Adjuvant Bevacizumab and Optune~Optune(NOVOTTF-100A)"
10792723|NCT01774721|BG000|Baseline|Dacomitinib|Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792724|NCT01774721|BG001|Baseline|Gefitinib|Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792725|NCT01774721|BG002|Baseline|Total|Total of all reporting groups
10792726|NCT01774721|FG000|Participant Flow|Dacomitinib|Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792727|NCT01774721|FG001|Participant Flow|Gefitinib|Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792728|NCT01774721|OG000|Outcome|Dacomitinib|Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792729|NCT01774721|OG001|Outcome|Gefitinib|Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792730|NCT01774721|OG000|Outcome|Dacomitinib|Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792731|NCT01774721|OG001|Outcome|Gefitinib|Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792732|NCT01774721|EG000|Reported Event|Dacomitinib|Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792733|NCT01774721|EG001|Reported Event|Gefitinib|Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
10792734|NCT01747447|BG000|Baseline|Vitamin D Group|Received active Vitamin D
10792735|NCT01747447|BG001|Baseline|Placebo Group|Received placebo Vitamin D
10792736|NCT01747447|BG002|Baseline|Total|Total of all reporting groups
10792737|NCT01747447|FG000|Participant Flow|Vitamin D Group|Received active Vitamin D
10792738|NCT01747447|FG001|Participant Flow|Placebo Group|Received placebo Vitamin D
10792739|NCT01747447|OG000|Outcome|Vitamin D Group|Received active Vitamin D
10792740|NCT01747447|OG001|Outcome|Placebo Group|Received placebo Vitamin D
10792741|NCT01747447|EG000|Reported Event|Vitamin D Group|Received active Vitamin D
10792742|NCT01747447|EG001|Reported Event|Placebo Group|Received placebo Vitamin D
10792743|NCT01709331|BG000|Baseline|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
10802687|NCT02344108|OG000|Outcome|Inspire® Upper Airway Simulation System|Following hypoglossal nerve stimulator implantation, titration polysomnography was performed 1, 2, 6, and 12 months after implantation.
10792744|NCT01709331|FG000|Participant Flow|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
10792745|NCT01709331|OG000|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
10792746|NCT01709331|EG000|Reported Event|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
10792747|NCT01689740|BG000|Baseline|Lead in: 125 mg MDMA (Open Label) and Psychotherapy|Participants receive open MDMA with an initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
10792748|NCT01689740|BG001|Baseline|Active Placebo Dose MDMA (25 mg) and Psychotherapy|Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792749|NCT01689740|BG002|Baseline|Full Dose MDMA (125 mg) and Psychotherapy|Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792750|NCT01689740|BG003|Baseline|Total|Total of all reporting groups
10792751|NCT01689740|FG000|Participant Flow|Lead in: 125 mg MDMA (Open Label) and Psychotherapy|"Open label: Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.~125 mg MDMA (open label): Initial dose of MDMA administered orally at the start of each of two psychotherapy sessions, supplement administered 1.5 to 2.5 hours later.~Psychotherapy: Psychotherapy provided throughout course of main study"
10792752|NCT01689740|FG001|Participant Flow|Active Placebo Dose MDMA and Psychotherapy|"Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.~Active placebo dose MDMA: Initial dose of 25 mg MDMA administered orally at the start of each of two separate psychotherapy sessions scheduled three to five weeks apart possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.~Psychotherapy: Psychotherapy provided throughout course of main study"
10792753|NCT01689740|FG002|Participant Flow|Full Dose MDMA and Psychotherapy|"Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.~Full dose MDMA: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions scheduled three to five weeks apart. In each case, it may be followed 1.5 to 2.5 hours later with 62.5 mg MDMA.~Psychotherapy: Psychotherapy provided throughout course of main study"
10792754|NCT01689740|OG000|Outcome|Lead in: 125 mg MDMA (Open Label) and Psychotherapy|Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
10792755|NCT01689740|OG001|Outcome|Active Placebo Dose MDMA (25 mg) and Psychotherapy|Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792756|NCT01689740|OG002|Outcome|Full Dose MDMA (125 mg) and Psychotherapy|Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792757|NCT01689740|OG000|Outcome|Active Placebo Dose MDMA (25 mg)/ Stage 2 Crossover|"Stage 1: Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.~Stage 2: Participants crossover to receive two open-label sessions of MDMA-assisted psychotherapy with 125 mg MDMA followed by a supplemental dose of 62.5 mg."
10792758|NCT01689740|EG000|Reported Event|Lead in: 125 mg MDMA (Open Label) and Psychotherapy|Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
10792759|NCT01689740|EG001|Reported Event|Active Placebo Dose MDMA (25 mg) and Psychotherapy (Stage 1)|Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792760|NCT01689740|EG002|Reported Event|Full Dose MDMA (125 mg) and Psychotherapy (Stage 1)|Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792761|NCT01689740|EG003|Reported Event|Full Dose MDMA (125 mg) and Psychotherapy (Stage 2)|Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
10792762|NCT01656434|BG000|Baseline|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
10792763|NCT01656434|BG001|Baseline|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
10792764|NCT01656434|BG002|Baseline|Total|Total of all reporting groups
10792765|NCT01656434|FG000|Participant Flow|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
10792766|NCT01656434|FG001|Participant Flow|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
10792767|NCT01656434|OG000|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
10792768|NCT01656434|OG001|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
10792769|NCT01656434|EG000|Reported Event|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
10792770|NCT01656434|EG001|Reported Event|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
10792771|NCT01518517|BG000|Baseline|GRASPA (Non Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792772|NCT01518517|BG001|Baseline|Reference L-asparaginase (Non Allergic Population|"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).~•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).~NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)~•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).~L-asparaginase: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy"
10792773|NCT01518517|BG002|Baseline|GRASPA (Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792774|NCT01518517|BG003|Baseline|Total|Total of all reporting groups
10792775|NCT01518517|FG000|Participant Flow|GRASPA (Non Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792776|NCT01518517|FG001|Participant Flow|Reference L-asparaginase (Non Allergic Population)|"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).~•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).~NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)~•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).~L-asparaginase: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy"
10792777|NCT01518517|FG002|Participant Flow|GRASPA (Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10802688|NCT02344108|OG000|Outcome|Inspire® Upper Airway Simulation System|The quality of life instruments (OSA-18 and Epworth Sleepiness Scale [ESS]) were administered at baseline (preoperatively) and 12 months postoperatively.
10965767|NCT00883753|OG000|Outcome|Tocilizumab Monotherapy|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were not taking DMARDS at Core Baseline.
11195581|NCT02159352|EG001|Reported Event|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
11195582|NCT02159352|EG002|Reported Event|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
11195583|NCT02159352|EG003|Reported Event|Group 2: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100--mg ritonavir capsule once daily on Days 5 through 14.
11195584|NCT02159352|EG004|Reported Event|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
11195585|NCT02159352|EG005|Reported Event|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
11195586|NCT02159365|BG000|Baseline|E-Ld|E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
11195587|NCT02159365|FG000|Participant Flow|E-Ld|E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
11195588|NCT02159365|OG000|Outcome|E-Ld|E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
11195589|NCT02159365|EG000|Reported Event|E-Ld|E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
11195590|NCT02159469|BG000|Baseline|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg"
11195591|NCT02159469|FG000|Participant Flow|QST 50 mg / 75 mg / 100 mg|Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11195592|NCT02159469|OG000|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11195593|NCT02159469|OG000|Outcome|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg"
11195594|NCT02159469|EG000|Reported Event|Testosterone Enanthate Auto-injector|"Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.~Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg"
11195595|NCT02159482|BG000|Baseline|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
11195596|NCT02159482|FG000|Participant Flow|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
11195597|NCT02159482|OG000|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
11195598|NCT02159482|EG000|Reported Event|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
11195599|NCT02159521|BG000|Baseline|EkoSonic® Endovascular System|Thrombolytic infusion (Alteplase), at an infusion rate of 0.5-1.0 mg/hr was delivered to the participants with chronic lower extremity venous obstruction after DVT and PTS, through EkoSonic® Endovascular System for at least 12 hours and overnight as needed up to a maximum of 48 hrs. The alteplase dose could have been adjusted per investigator discretion, but was not exceeded 1 mg/hr or a total dose of 48 mg.
11195600|NCT02159521|FG000|Participant Flow|EkoSonic® Endovascular System|Thrombolytic infusion (Alteplase), at an infusion rate of 0.5-1.0 milligrams/hour (mg/hr) was delivered to the participants with chronic lower extremity venous obstruction after deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS), through EkoSonic® Endovascular System for at least 12 hours and overnight as needed up to a maximum of 48 hrs. The alteplase dose could have been adjusted per investigator discretion, but was not exceeded 1 mg/hr or a total dose of 48 mg.
11195601|NCT02159521|OG000|Outcome|EkoSonic® Endovascular System|Thrombolytic infusion (Alteplase), at an infusion rate of 0.5-1.0 mg/hr was delivered to the participants with chronic lower extremity venous obstruction after DVT and PTS, through EkoSonic® Endovascular System for at least 12 hours and overnight as needed up to a maximum of 48 hrs. The alteplase dose could have been adjusted per investigator discretion, but was not exceeded 1 mg/hr or a total dose of 48 mg.
11195602|NCT02159521|EG000|Reported Event|EkoSonic® Endovascular System|Thrombolytic infusion (Alteplase), at an infusion rate of 0.5-1.0 mg/hr was delivered to the participants with chronic lower extremity venous obstruction after DVT and PTS, through EkoSonic® Endovascular System for at least 12 hours and overnight as needed up to a maximum of 48 hrs. The alteplase dose could have been adjusted per investigator discretion, but was not exceeded 1 mg/hr or a total dose of 48 mg.
11202213|NCT02206061|EG000|Reported Event|School-Based Asthma Care for Teens (SB-ACT)|"SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.~The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.~School-Based Asthma Care for Teens (SB-ACT)"
11202214|NCT02206061|EG001|Reported Event|Directly Observed Therapy|"For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).~Directly Observed Therapy"
11202215|NCT02206061|EG002|Reported Event|Asthma Education|"Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.~Asthma Education"
11202216|NCT02206152|BG000|Baseline|All Subjects|All participants at baseline
11202217|NCT02206152|FG000|Participant Flow|All Participants|Crossover design: All participants included in baseline data.
11202218|NCT02206152|OG000|Outcome|Placebo|"Normal Saline IV infusion given during a controlled hyperinsulinemic hypoglycemic insulin clamp~Placebo"
10792778|NCT01518517|OG000|Outcome|GRASPA Non Allergic|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792779|NCT01518517|OG001|Outcome|Reference L-asparaginase|"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).~•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).~NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)~•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).~L-asparaginase: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy"
10792780|NCT01518517|OG000|Outcome|GRASPA (Non Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792781|NCT01518517|OG001|Outcome|Reference L-asparaginase (Non Allergic Population)|"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).~•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).~NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)~•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).~L-asparaginase: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy"
10792782|NCT01518517|OG002|Outcome|GRASPA (Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792783|NCT01518517|EG000|Reported Event|GRASPA (Non Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792784|NCT01518517|EG001|Reported Event|Reference L-asparaginase (Non Allergic Population)|"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).~•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).~NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)~•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).~L-asparaginase: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy"
10792785|NCT01518517|EG002|Reported Event|GRASPA (Allergic Population)|"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).~GRASPA® administration takes place as below:~for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)~for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)~GRASPA: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy"
10792786|NCT01496118|BG000|Baseline|Dose Level 1|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 27 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792787|NCT01496118|BG001|Baseline|Dose Level 2|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 36 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792788|NCT01496118|BG002|Baseline|Dose Level 3|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792789|NCT01496118|BG003|Baseline|Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792790|NCT01496118|BG004|Baseline|Dose Level 5|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19"
10792791|NCT01496118|BG005|Baseline|Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
11195603|NCT02159547|BG000|Baseline|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
11195604|NCT02159547|BG001|Baseline|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
10792792|NCT01496118|BG006|Baseline|Expansion Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792793|NCT01496118|BG007|Baseline|Expansion Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792794|NCT01496118|BG008|Baseline|Total|Total of all reporting groups
10792795|NCT01496118|FG000|Participant Flow|Dose Level 1|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 27 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 27 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792796|NCT01496118|FG001|Participant Flow|Dose Level 2|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 36 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 36 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792797|NCT01496118|FG002|Participant Flow|Dose Level 3|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792798|NCT01496118|FG003|Participant Flow|Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792799|NCT01496118|FG004|Participant Flow|Dose Level 5|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19"
10792800|NCT01496118|FG005|Participant Flow|Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792801|NCT01496118|FG006|Participant Flow|Expansion Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792802|NCT01496118|FG007|Participant Flow|Expansion Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792803|NCT01496118|OG000|Outcome|Dose Level 1|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 27 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792804|NCT01496118|OG001|Outcome|Dose Level 2|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 36 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792805|NCT01496118|OG002|Outcome|Dose Level 3|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792806|NCT01496118|OG003|Outcome|Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792807|NCT01496118|OG004|Outcome|Dose Level 5|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19"
10792808|NCT01496118|OG005|Outcome|Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792809|NCT01496118|OG000|Outcome|Dose Level 4 - Escalation and Expansion|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19"
10792810|NCT01496118|OG001|Outcome|Dose Level 6 - Escalation and Expansion|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19"
10792811|NCT01496118|EG000|Reported Event|Dose Level 1|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 27 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792812|NCT01496118|EG001|Reported Event|Dose Level 2|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 36 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
11195605|NCT02159547|BG002|Baseline|Total|Total of all reporting groups
10792813|NCT01496118|EG002|Reported Event|Dose Level 3|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792814|NCT01496118|EG003|Reported Event|Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792815|NCT01496118|EG004|Reported Event|Dose Level 5|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19"
10792816|NCT01496118|EG005|Reported Event|Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792817|NCT01496118|EG006|Reported Event|Expansion Dose Level 4|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 45 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792818|NCT01496118|EG007|Reported Event|Expansion Dose Level 6|"Carfilzomib : cycle 1 - 20 mg/m^2 IV D1, 2 ; 56 mg/m^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m^2 IV D 1, 2, 8, 9, 15, 16~Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19~panobinostat: Specified dose on specified days~carfilzomib: Specified dose on specified days"
10792819|NCT01350934|BG000|Baseline|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
10792820|NCT01350934|BG001|Baseline|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
10792821|NCT01350934|BG002|Baseline|Total|Total of all reporting groups
10792822|NCT01350934|FG000|Participant Flow|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
10792823|NCT01350934|FG001|Participant Flow|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
10792824|NCT01350934|OG000|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
11195606|NCT02159547|FG000|Participant Flow|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
11195607|NCT02159547|FG001|Participant Flow|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
10792825|NCT01350934|OG001|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
10792826|NCT01350934|EG000|Reported Event|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
10792827|NCT01350934|EG001|Reported Event|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
10792828|NCT01286207|BG000|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792829|NCT01286207|BG001|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792830|NCT01286207|BG002|Baseline|Standard Care|Standard care at onset of migraine attack
11195608|NCT02159547|OG000|Outcome|Dexketoprofen|50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
10792831|NCT01286207|BG003|Baseline|Total|Total of all reporting groups
10792832|NCT01286207|FG000|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792833|NCT01286207|FG001|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
11195609|NCT02159547|OG001|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
11195610|NCT02159547|OG000|Outcome|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
11195611|NCT02159547|EG000|Reported Event|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
10792834|NCT01286207|FG002|Participant Flow|Standard Care|Standard care at onset of migraine attack
11195612|NCT02159547|EG001|Reported Event|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
11195613|NCT02159703|BG000|Baseline|Single Arm Phase 2|"TORS~Adjuvant Radiation Therapy"
11195614|NCT02159703|FG000|Participant Flow|Single Arm Phase 2|Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy)
11195615|NCT02159703|OG000|Outcome|Single Arm Phase 2|"TORS~Adjuvant Radiation Therapy"
11195616|NCT02159703|EG000|Reported Event|Single Arm Phase 2|"TORS~Adjuvant Radiation Therapy"
11195617|NCT02159729|BG000|Baseline|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
10792835|NCT01286207|OG000|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792836|NCT01286207|OG001|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792837|NCT01286207|OG002|Outcome|Standard Care|Standard care at onset of migraine attack
11195618|NCT02159729|BG001|Baseline|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
11195619|NCT02159729|BG002|Baseline|Total|Total of all reporting groups
10792838|NCT01286207|EG000|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792839|NCT01286207|EG001|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
10792840|NCT01286207|EG002|Reported Event|Standard Care|Standard care at onset of migraine attack
10792841|NCT01263769|BG000|Baseline|Axitinib|5 mg by mouth twice each day for 12 weeks.
10792842|NCT01263769|FG000|Participant Flow|Axitinib|5 mg by mouth twice each day for 12 weeks.
10792843|NCT01263769|OG000|Outcome|Axitinib|5 mg by mouth twice each day for 12 weeks.
10792844|NCT01263769|EG000|Reported Event|Axitinib|5 mg by mouth twice each day for 12 weeks.
10792845|NCT01227187|BG000|Baseline|Infusion Rate of 12 mcg/kg/h|
10792846|NCT01227187|BG001|Baseline|Infusion Rate of 18 mcg/kg/h|
10792847|NCT01227187|BG002|Baseline|Infusion Rate of 24 mcg/kg/h|
10792848|NCT01227187|BG003|Baseline|Infusion Rate of 30 mcg/kg/h|
10792849|NCT01227187|BG004|Baseline|Total|Total of all reporting groups
11195620|NCT02159729|FG000|Participant Flow|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
10792850|NCT01227187|FG000|Participant Flow|APC Initiation Dose of 12 μg/kg/h|Activated protein C initiation dose of 12 μg/kg/h for the first patient
10792851|NCT01227187|FG001|Participant Flow|APC Initiation Dose of 18 μg/kg/h|Activated protein C initiation dose of 18 μg/kg/h
10792852|NCT01227187|FG002|Participant Flow|APC Initiation Dose of 24 μg/kg/h|Activated protein C initiation dose of 24 μg/kg/h
11195621|NCT02159729|FG001|Participant Flow|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
10792853|NCT01227187|FG003|Participant Flow|APC Initiation Dose of 30 μg/kg/h|Activated protein C initiation dose of 30 μg/kg/h
10792854|NCT01227187|OG000|Outcome|APC Initiation Dose 12 μg/kg/h|APC Initiation dose 12 μg/kg/h
10792855|NCT01227187|OG001|Outcome|APC Initiation Dose 18 μg/kg/h|APC Initiation dose 18 μg/kg/h
10792856|NCT01227187|OG002|Outcome|APC Initiation Dose 24 μg/kg/h|APC Initiation dose 24 μg/kg/h
11195622|NCT02159729|OG000|Outcome|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
10792857|NCT01227187|OG003|Outcome|APC Initiation Dose 30 μg/kg/h|APC Initiation dose 30 μg/kg/h
10792858|NCT01227187|EG000|Reported Event|APC Initiation Dose 12 μg/kg/h|APC initiation dose 12 μg/kg/h
10792859|NCT01227187|EG001|Reported Event|APC Initiation Dose 18 μg/kg/h|APC initiation dose 18 μg/kg/h
10792860|NCT01227187|EG002|Reported Event|APC Initiation Dose 24 μg/kg/h|APC initiation dose 24 μg/kg/h
10792861|NCT01227187|EG003|Reported Event|APC Initiation Dose 30 μg/kg/h|APC initiation dose 30 μg/kg/h
10792862|NCT01222247|BG000|Baseline|Betamethasone|"A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart~Betamethasone: The active study drug, betamethasone. 3 mg per ml betamethasone sodium phosphate 3 mg per milliliter betamethasone acetate The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later."
10792863|NCT01222247|BG001|Baseline|Placebo|"A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart~Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart."
10792864|NCT01222247|BG002|Baseline|Total|Total of all reporting groups
10792865|NCT01222247|FG000|Participant Flow|Betamethasone|A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart
10792866|NCT01222247|FG001|Participant Flow|Placebo|"A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart~Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart."
10792867|NCT01222247|OG000|Outcome|Betamethasone|A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart
10792868|NCT01222247|OG001|Outcome|Placebo|"A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart~Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart."
10792869|NCT01222247|EG000|Reported Event|Betamethasone|A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart
10792870|NCT01222247|EG001|Reported Event|Placebo|"A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart~Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart."
10792871|NCT01211405|BG000|Baseline|Low Dose MDMA (30 mg)|"Participants will receive 30 mg MDMA during each of two blinded experimental sessions.~Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later~Psychotherapy: Non-directive psychotherapy during each session"
11195623|NCT02159729|OG001|Outcome|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
10792872|NCT01211405|BG001|Baseline|Medium Dose MDMA (75 mg)|"Participants will receive 75 mg MDMA on each of two blinded experimental sessions~Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg~Psychotherapy: Non-directive psychotherapy during each session"
10792873|NCT01211405|BG002|Baseline|Full Dose MDMA (125 mg)|"Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.~Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.~Psychotherapy: Non-directive psychotherapy during each session"
10792874|NCT01211405|BG003|Baseline|Total|Total of all reporting groups
10792875|NCT01211405|FG000|Participant Flow|Low Dose MDMA (30 mg)|"Participants will receive 30 mg MDMA during each of two blinded experimental sessions.~Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later~Psychotherapy: Non-directive psychotherapy during each session"
10792876|NCT01211405|FG001|Participant Flow|Medium Dose MDMA (75 mg)|"Participants will receive 75 mg MDMA on each of two blinded experimental sessions~Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg~Psychotherapy: Non-directive psychotherapy during each session"
10792877|NCT01211405|FG002|Participant Flow|Full Dose MDMA (125 mg)|"Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.~Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.~Psychotherapy: Non-directive psychotherapy during each session"
10792878|NCT01211405|OG000|Outcome|Low Dose MDMA (30 mg)|"Participants will receive 30 mg MDMA during each of two blinded experimental sessions.~Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later~Psychotherapy: Non-directive psychotherapy during each session"
10792879|NCT01211405|OG001|Outcome|Medium Dose MDMA (75 mg)|"Participants will receive 75 mg MDMA on each of two blinded experimental sessions~Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg~Psychotherapy: Non-directive psychotherapy during each session"
10792880|NCT01211405|OG002|Outcome|Full Dose MDMA (125 mg)|"Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.~Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.~Psychotherapy: Non-directive psychotherapy during each session"
10792881|NCT01211405|EG000|Reported Event|Low Dose MDMA (30 mg)|"Participants will receive 30 mg MDMA during each of two blinded experimental sessions.~Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later~Psychotherapy: Non-directive psychotherapy during each session"
10792882|NCT01211405|EG001|Reported Event|Medium Dose MDMA (75 mg)|"Participants will receive 75 mg MDMA on each of two blinded experimental sessions~Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg~Psychotherapy: Non-directive psychotherapy during each session"
10792883|NCT01211405|EG002|Reported Event|Full Dose MDMA (125 mg)|"Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.~Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.~Psychotherapy: Non-directive psychotherapy during each session"
10792884|NCT01146418|BG000|Baseline|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792885|NCT01146418|BG001|Baseline|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792886|NCT01146418|BG002|Baseline|Total|Total of all reporting groups
10792887|NCT01146418|FG000|Participant Flow|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792888|NCT01146418|FG001|Participant Flow|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
11195624|NCT02159729|EG000|Reported Event|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
11195625|NCT02159729|EG001|Reported Event|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
11195626|NCT02159768|BG000|Baseline|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
11195627|NCT02159768|FG000|Participant Flow|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
10792889|NCT01146418|FG002|Participant Flow|Corifollitropin Alfa 150 μg Live-Born Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
10792890|NCT01146418|FG003|Participant Flow|recFSH 300 IU Live-Born Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
10792891|NCT01146418|OG000|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792892|NCT01146418|OG001|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792893|NCT01146418|EG000|Reported Event|Corifollitropin Alfa 150 μg Participants With ET|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792894|NCT01146418|EG001|Reported Event|recFSH 300 IU Participants With ET|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792895|NCT01146418|EG002|Reported Event|Corifollitropin Alfa 150 μg Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792896|NCT01146418|EG003|Reported Event|recFSH 300 IU Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
10792897|NCT01146418|EG004|Reported Event|Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
10792898|NCT01146418|EG005|Reported Event|recFSH 300 IU Follow-up Fetuses/Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
10792899|NCT01144416|BG000|Baseline|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
10792900|NCT01144416|BG001|Baseline|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
10792901|NCT01144416|BG002|Baseline|Total|Total of all reporting groups
10792902|NCT01144416|FG000|Participant Flow|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
10792903|NCT01144416|FG001|Participant Flow|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
10792904|NCT01144416|OG000|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
11195628|NCT02159768|OG000|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
11195629|NCT02159768|EG000|Reported Event|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
11195630|NCT02159807|BG000|Baseline|1.25 mg Bupivacaine|1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
11195631|NCT02159807|BG001|Baseline|1.66 mg Bupivacaine|1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10792905|NCT01144416|OG001|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
10792906|NCT01144416|OG000|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
10792907|NCT01144416|OG001|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
10792908|NCT01144416|EG000|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
10792909|NCT01144416|EG001|Reported Event|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
10792910|NCT01144416|EG002|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962-Follow-up|Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
10792911|NCT01144416|EG003|Reported Event|Daily 300 IU recFSH -Follow-up|Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
10792912|NCT01140048|BG000|Baseline|All Enrolled Participants|
10792913|NCT01140048|FG000|Participant Flow|All Enrolled Participants|
10792914|NCT01140048|OG000|Outcome|All Enrolled Participants|
10792915|NCT01140048|EG000|Reported Event|All Enrolled Participants|
11195632|NCT02159807|BG002|Baseline|2.5 mg Bupivacaine|2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10792916|NCT01077817|BG000|Baseline|Overall Study Population|
10792917|NCT01077817|FG000|Participant Flow|Overall Study Population|
10792918|NCT01077817|OG000|Outcome|Esophageal Cancer Cohort|Participants with any GPRD Medical Code for esophageal cancer (cases).
10792919|NCT01077817|OG001|Outcome|Comparison Sample (Case Cohort)|Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
11195633|NCT02159807|BG003|Baseline|Total|Total of all reporting groups
10792920|NCT01077817|OG000|Outcome|Comparators|Participants who did not initiate osteoporosis treatment with a study drug
10792921|NCT01077817|OG001|Outcome|Alendronate|Participants who initiated osteoporosis treatment with alendronate
10792922|NCT01077817|OG002|Outcome|Etidronate|Participants who initiated osteoporosis treatment with etidronate
10792923|NCT01077817|OG003|Outcome|Ibandronate|Participants who initiated osteoporosis treatment with ibandronate
10965768|NCT00883753|OG001|Outcome|Tocilizumab + 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking one DMARD at Core study Baseline.
11195634|NCT02159807|FG000|Participant Flow|1.25 mg Bupivacaine|1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10792924|NCT01077817|OG004|Outcome|Risendronate|Participants who initiated osteoporosis treatment with risedronate
10792925|NCT01077817|OG005|Outcome|Raloxifene|Participants who initiated osteoporosis treatment with raloxifene
10792926|NCT01077817|EG000|Reported Event|Overall Study Population|
10792927|NCT01065779|BG000|Baseline|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
10792928|NCT01065779|FG000|Participant Flow|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
10792929|NCT01065779|OG000|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
10792930|NCT01065779|EG000|Reported Event|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
10792931|NCT00974571|BG000|Baseline|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792932|NCT00974571|BG001|Baseline|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
10792933|NCT00974571|BG002|Baseline|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792934|NCT00974571|BG003|Baseline|Total|Total of all reporting groups
10792935|NCT00974571|FG000|Participant Flow|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792936|NCT00974571|FG001|Participant Flow|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
10792937|NCT00974571|FG002|Participant Flow|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792938|NCT00974571|OG000|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792939|NCT00974571|OG001|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
10792940|NCT00974571|OG002|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792941|NCT00974571|EG000|Reported Event|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792942|NCT00974571|EG001|Reported Event|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
10792943|NCT00974571|EG002|Reported Event|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
10792944|NCT00972738|BG000|Baseline|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792945|NCT00972738|BG001|Baseline|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792946|NCT00972738|BG002|Baseline|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792947|NCT00972738|BG003|Baseline|Total|Total of all reporting groups
10792948|NCT00972738|FG000|Participant Flow|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792949|NCT00972738|FG001|Participant Flow|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792950|NCT00972738|FG002|Participant Flow|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792951|NCT00972738|OG000|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792952|NCT00972738|OG001|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792953|NCT00972738|OG002|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792954|NCT00972738|EG000|Reported Event|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
11195635|NCT02159807|FG001|Participant Flow|1.66 mg Bupivacaine|1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10792955|NCT00972738|EG001|Reported Event|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792956|NCT00972738|EG002|Reported Event|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792957|NCT00968201|BG000|Baseline|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
10792958|NCT00968201|BG001|Baseline|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
10792959|NCT00968201|BG002|Baseline|Total|Total of all reporting groups
10792960|NCT00968201|FG000|Participant Flow|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
10792961|NCT00968201|FG001|Participant Flow|Usual Care|"Usual care, defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
10792962|NCT00968201|FG002|Participant Flow|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
10792963|NCT00968201|OG000|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
10792964|NCT00968201|OG001|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
10792965|NCT00968201|OG000|Outcome|Usual Care|"Usual care, defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
10792966|NCT00968201|OG001|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
10792967|NCT00968201|EG000|Reported Event|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
10792968|NCT00968201|EG001|Reported Event|Usual Care|"Usual care, defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
10802689|NCT02344108|EG000|Reported Event|Inspire® Upper Airway Simulation System|Following hypoglossal nerve stimulator implantation, participants returned for follow-up study visits 1 week, 1 month, 2 months, 6 months, and 12 months postoperatively. Adverse events were queried from the time of enrollment to the time of completing the 12 month visit.
10792969|NCT00968201|EG002|Reported Event|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
10792970|NCT00968149|BG000|Baseline|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
10792971|NCT00968149|BG001|Baseline|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
10792972|NCT00968149|BG002|Baseline|Total|Total of all reporting groups
10792973|NCT00968149|FG000|Participant Flow|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
10792974|NCT00968149|FG001|Participant Flow|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
10792975|NCT00968149|OG000|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
10792976|NCT00968149|OG001|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
10792977|NCT00968149|EG000|Reported Event|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
10792978|NCT00968149|EG001|Reported Event|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
10792979|NCT00963469|BG000|Baseline|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792980|NCT00963469|BG001|Baseline|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792981|NCT00963469|BG002|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
10792982|NCT00963469|BG003|Baseline|Total|Total of all reporting groups
10792983|NCT00963469|FG000|Participant Flow|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792984|NCT00963469|FG001|Participant Flow|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792985|NCT00963469|FG002|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
10792986|NCT00963469|OG000|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792987|NCT00963469|OG001|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792988|NCT00963469|OG002|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
10792989|NCT00963469|EG000|Reported Event|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792990|NCT00963469|EG001|Reported Event|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
10792991|NCT00963469|EG002|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
10792992|NCT00960141|BG000|Baseline|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
10792993|NCT00960141|BG001|Baseline|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792994|NCT00960141|BG002|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
10792995|NCT00960141|BG003|Baseline|Total|Total of all reporting groups
10792996|NCT00960141|FG000|Participant Flow|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
10792997|NCT00960141|FG001|Participant Flow|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10792998|NCT00960141|FG002|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
10792999|NCT00960141|OG000|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
10793000|NCT00960141|OG001|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10793001|NCT00960141|OG002|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
10793002|NCT00960141|EG000|Reported Event|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
10793003|NCT00960141|EG001|Reported Event|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
10793004|NCT00960141|EG002|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
10793005|NCT00943683|BG000|Baseline|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793006|NCT00943683|BG001|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793007|NCT00943683|BG002|Baseline|Total|Total of all reporting groups
10793008|NCT00943683|FG000|Participant Flow|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793009|NCT00943683|FG001|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793010|NCT00943683|OG000|Outcome|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793011|NCT00943683|OG001|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793012|NCT00943683|EG000|Reported Event|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
11195636|NCT02159807|FG002|Participant Flow|2.5 mg Bupivacaine|2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10793013|NCT00943683|EG001|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
10793014|NCT00943397|BG000|Baseline|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
10793015|NCT00943397|BG001|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
10793016|NCT00943397|BG002|Baseline|Total|Total of all reporting groups
10793017|NCT00943397|FG000|Participant Flow|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
10793018|NCT00943397|FG001|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
10793019|NCT00943397|OG000|Outcome|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
10793020|NCT00943397|OG001|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
10793021|NCT00943397|EG000|Reported Event|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
10793022|NCT00943397|EG001|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
10965769|NCT00883753|OG002|Outcome|Tocilizumab + > 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking more than one DMARD at Core study Baseline.
11195637|NCT02159807|OG000|Outcome|1.25 mg Bupivacaine|1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10793028|NCT00911547|BG000|Baseline|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793029|NCT00911547|BG001|Baseline|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793030|NCT00911547|BG002|Baseline|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793031|NCT00911547|BG003|Baseline|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793032|NCT00911547|BG004|Baseline|Total|Total of all reporting groups
10793033|NCT00911547|FG000|Participant Flow|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10802690|NCT02335658|BG000|Baseline|DSP-5423P (Cohort 1)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802691|NCT02335658|BG001|Baseline|DSP-5423P (Cohort 2)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802692|NCT02335658|BG002|Baseline|Total|Total of all reporting groups
10793034|NCT00911547|FG001|Participant Flow|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793035|NCT00911547|FG002|Participant Flow|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793036|NCT00911547|FG003|Participant Flow|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793037|NCT00911547|OG000|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793038|NCT00911547|OG001|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793039|NCT00911547|OG002|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793040|NCT00911547|OG003|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793041|NCT00911547|EG000|Reported Event|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793042|NCT00911547|EG001|Reported Event|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
10793043|NCT00911547|EG002|Reported Event|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
10793044|NCT00911547|EG003|Reported Event|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
11195638|NCT02159807|OG001|Outcome|1.66 mg Bupivacaine|1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10793045|NCT00899379|BG000|Baseline|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793046|NCT00899379|BG001|Baseline|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793047|NCT00899379|BG002|Baseline|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793048|NCT00899379|BG003|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793049|NCT00899379|BG004|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793050|NCT00899379|BG005|Baseline|Total|Total of all reporting groups
10793051|NCT00899379|FG000|Participant Flow|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793052|NCT00899379|FG001|Participant Flow|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10965770|NCT00883753|OG000|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
11195639|NCT02159807|OG002|Outcome|2.5 mg Bupivacaine|2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10793053|NCT00899379|FG002|Participant Flow|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793054|NCT00899379|FG003|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793055|NCT00899379|FG004|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
10793056|NCT00899379|OG000|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
10793057|NCT00899379|OG001|Outcome|Placebo|All Placebo patients from all Treatment Sequences
10793058|NCT00899379|EG000|Reported Event|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
10793059|NCT00899379|EG001|Reported Event|Placebo|All Placebo patients from all Treatment Sequences
10793060|NCT00898677|BG000|Baseline|Rizatriptan 5 mg|"Rizatriptan 5 mg orally once for treatment of single migraine attack.~Baseline measure Participants reported are those participants that recieved study treatment."
10793061|NCT00898677|BG001|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
10793062|NCT00898677|BG002|Baseline|Sumatriptan 100 mg|"Sumatriptan 100 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
10793063|NCT00898677|BG003|Baseline|Placebo|"Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
10793064|NCT00898677|BG004|Baseline|Total|Total of all reporting groups
10793065|NCT00898677|FG000|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793066|NCT00898677|FG001|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
11195640|NCT02159807|EG000|Reported Event|1.25 mg Bupivacaine|1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
11195641|NCT02159807|EG001|Reported Event|1.66 mg Bupivacaine|1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
11195642|NCT02159807|EG002|Reported Event|2.5 mg Bupivacaine|2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
10793067|NCT00898677|FG002|Participant Flow|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
10793068|NCT00898677|FG003|Participant Flow|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
10793069|NCT00898677|OG000|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793070|NCT00898677|OG001|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793071|NCT00898677|OG002|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
10793072|NCT00898677|OG003|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
10793073|NCT00898677|EG000|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793074|NCT00898677|EG001|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793075|NCT00898677|EG002|Reported Event|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
10793076|NCT00898677|EG003|Reported Event|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
10793077|NCT00897949|BG000|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793078|NCT00897949|BG001|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793079|NCT00897949|BG002|Baseline|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
10793080|NCT00897949|BG003|Baseline|Total|Total of all reporting groups
10793081|NCT00897949|FG000|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793082|NCT00897949|FG001|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793083|NCT00897949|FG002|Participant Flow|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
10793084|NCT00897949|OG000|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793085|NCT00897949|OG001|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793086|NCT00897949|OG002|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
10793087|NCT00897949|OG000|Outcome|Rizatriptan 5 mg / Rizatriptan 5 mg|Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
10793088|NCT00897949|OG001|Outcome|Rizatriptan 5 mg / Placebo|Rizatriptan 5 mg initially, prerandomized to placebo
10793089|NCT00897949|OG002|Outcome|Rizatriptan 10 mg / Rizatriptan 10 mg|Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
10793090|NCT00897949|OG003|Outcome|Rizatriptan 10 mg / Placebo|Rizatriptan 10 mg initially, prerandomized to placebo
10793091|NCT00897949|OG004|Outcome|Placebo / Rizatriptan 5 mg|Placebo initially, prerandomized to rizatriptan 5 mg
10793092|NCT00897949|OG005|Outcome|Placebo / Rizatriptan 10 mg|Placebo initially, prerandomized to rizatriptan 10 mg
10793093|NCT00897949|EG000|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
11195643|NCT02159859|BG000|Baseline|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
11383283|NCT02381652|FG001|Participant Flow|Cingal/Monovisc|"Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
10793094|NCT00897949|EG001|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
10793095|NCT00897949|EG002|Reported Event|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
10793096|NCT00897104|BG000|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793097|NCT00897104|BG001|Baseline|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
10793098|NCT00897104|BG002|Baseline|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
10793099|NCT00897104|BG003|Baseline|Total|Total of all reporting groups
10793100|NCT00897104|FG000|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793101|NCT00897104|FG001|Participant Flow|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
11195644|NCT02159859|FG000|Participant Flow|Ertapenem|"Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session~Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn"
10793102|NCT00897104|FG002|Participant Flow|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
10793103|NCT00897104|OG000|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793104|NCT00897104|OG001|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
10793105|NCT00897104|OG002|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
10793106|NCT00897104|EG000|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
10793107|NCT00897104|EG001|Reported Event|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
11195645|NCT02159859|OG000|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
11195646|NCT02159859|EG000|Reported Event|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
10793108|NCT00897104|EG002|Reported Event|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
10793109|NCT00803790|BG000|Baseline|Part 1|"Alendronate+vitamin D combo, then alendronate: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 70mg alendronate tablet. A washout of at least 12 days separated each treatment period.~Alendronate, then alendronate+vitamin D combo: In Period 1 participants received 70mg alendronate tablet, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
10793110|NCT00803790|BG001|Baseline|Part 2|"Alendronate+vitamin D combo, then vitamin D: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets. A washout of at least 12 days separated each treatment period.~Vitamin D, then alendronate+vitamin D combo: In Period 1 participants received a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
10965771|NCT00883753|EG000|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
10793111|NCT00803790|BG002|Baseline|Total|Total of all reporting groups
10793112|NCT00803790|FG000|Participant Flow|Part 1 Alendronate+Vitamin D Combo, Then Alendronate|Participants in Part 1 received a single dose of 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by a single dose of 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
10793113|NCT00803790|FG001|Participant Flow|Part 1 Alendronate, Then Alendronate+Vitamin D Combo|Participants in Part 1 received a single dose of 70mg alendronate tablet in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
10793114|NCT00803790|FG002|Participant Flow|Part 2 Alendronate+Vitamin D Combo, Then Vitamin D|Participants in Part 2 received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
10793115|NCT00803790|FG003|Participant Flow|Part 2 Vitamin D, Then Alendronate+Vitamin D Combo|Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
10793116|NCT00803790|OG000|Outcome|Alendronate+Vitamin D Combo|Single dose of 70mg alendronate+5600 IU vitamin D combination tablet
10793117|NCT00803790|OG001|Outcome|Alendronate|Single dose of 70mg alendronate tablet
10793118|NCT00803790|OG000|Outcome|Alendronate+Vitamin D Combo|A single dose of 70mg alendronate+5600 IU vitamin D combination tablet
10793119|NCT00803790|OG001|Outcome|Vitamin D|Single dose of 5600 IU vitamin D administered as 2 x 2800 IU tablets
10793120|NCT00803790|OG000|Outcome|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
10793121|NCT00803790|OG001|Outcome|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
10793122|NCT00803790|EG000|Reported Event|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
10793123|NCT00803790|EG001|Reported Event|Alendronate|Single dose of 70mg alendronate tablet
11195647|NCT02159872|BG000|Baseline|Omacetaxine|"Omacetaxine 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. Participant may continue taking the study drug for up to 24 cycles of treatment.~Omacetaxine: 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle."
10793124|NCT00803790|EG002|Reported Event|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
10793125|NCT00725491|BG000|Baseline|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
10793126|NCT00725491|BG001|Baseline|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
10793127|NCT00725491|BG002|Baseline|Total|Total of all reporting groups
10793128|NCT00725491|FG000|Participant Flow|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
10793129|NCT00725491|FG001|Participant Flow|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
10793130|NCT00725491|OG000|Outcome|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
10793131|NCT00725491|OG001|Outcome|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
10793132|NCT00725491|EG000|Reported Event|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
10793133|NCT00725491|EG001|Reported Event|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
10802693|NCT02335658|FG000|Participant Flow|DSP-5423P (Cohort 1)|Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 1 was corresponding to the final dose of DSP-5423 (tablet) in previous period.
10802694|NCT02335658|FG001|Participant Flow|DSP-5423P (Cohort 2)|Percutaneous DSP-5423P: 40-80mg/day, once daily The initial dose of DSP-5423P in Cohort 2 was 40 mg/day
10802695|NCT02335658|OG000|Outcome|DSP-5423P (Cohort 1)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802696|NCT02335658|OG001|Outcome|DSP-5423P (Cohort 2)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802697|NCT02335658|OG002|Outcome|DSP-5423P (Overall)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802698|NCT02335658|EG000|Reported Event|DSP-5423P (Cohort 1)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802699|NCT02335658|EG001|Reported Event|DSP-5423P (Cohort 2)|"Percutaneous~DSP-5423P: 40-80mg/day"
10802700|NCT02335658|EG002|Reported Event|DSP-5423P (Overall)|"Percutaneous~DSP-5423P: 40-80mg/day~Cohort 1 + Cohort 2"
10802701|NCT02287584|BG000|Baseline|DSP-5423P Placebo|"Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily"
10802702|NCT02287584|BG001|Baseline|DSP-5423P 40mg|"Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily"
10802703|NCT02287584|BG002|Baseline|DSP-5423P 80mg|"Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily"
10802704|NCT02287584|BG003|Baseline|Total|Total of all reporting groups
10802705|NCT02287584|FG000|Participant Flow|DSP-5423P Placebo|"Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily"
10802706|NCT02287584|FG001|Participant Flow|DSP-5423P 40mg|"Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily"
10802707|NCT02287584|FG002|Participant Flow|DSP-5423P 80mg|"Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily"
10802708|NCT02287584|FG003|Participant Flow|DSP-5423P Placebo-to-Flex|"Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.~DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day."
10802709|NCT02287584|FG004|Participant Flow|DSP-5423P 40mg-to-Flex|"Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.~DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day."
11195648|NCT02159872|FG000|Participant Flow|Omacetaxine|"Omacetaxine 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. Participant may continue taking the study drug for up to 24 cycles of treatment.~Omacetaxine: 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle."
11195649|NCT02159872|OG000|Outcome|Omacetaxine|"Omacetaxine 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. Participant may continue taking the study drug for up to 24 cycles of treatment.~Omacetaxine: 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle."
10793134|NCT00703014|BG000|Baseline|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793135|NCT00703014|BG001|Baseline|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793136|NCT00703014|BG002|Baseline|Total|Total of all reporting groups
10793137|NCT00703014|FG000|Participant Flow|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793138|NCT00703014|FG001|Participant Flow|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793139|NCT00703014|FG002|Participant Flow|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
10793140|NCT00703014|FG003|Participant Flow|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
10793141|NCT00703014|OG000|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793142|NCT00703014|OG001|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793143|NCT00703014|OG000|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
10793144|NCT00703014|OG001|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
10793145|NCT00703014|EG000|Reported Event|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10849949|NCT00299182|EG004|Reported Event|1 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10793146|NCT00703014|EG001|Reported Event|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
10793147|NCT00703014|EG002|Reported Event|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
10793148|NCT00703014|EG003|Reported Event|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
10793149|NCT00702845|BG000|Baseline|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
10793150|NCT00702845|BG001|Baseline|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
10793151|NCT00702845|BG002|Baseline|Total|Total of all reporting groups
10793152|NCT00702845|FG000|Participant Flow|100 μg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
10793153|NCT00702845|FG001|Participant Flow|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
10793154|NCT00702845|OG000|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
10793155|NCT00702845|OG001|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
10793156|NCT00702845|EG000|Reported Event|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
11338985|NCT03621787|OG000|Outcome|Single Arm Study: Implant Insertion|"Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire will assess bruising and infection risk. A final visit will assess bruising and infection risk by a physician.~Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately."
10793157|NCT00702845|EG001|Reported Event|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
10793158|NCT00702624|BG000|Baseline|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10793159|NCT00702624|BG001|Baseline|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
10793160|NCT00702624|BG002|Baseline|Total|Total of all reporting groups
10793161|NCT00702624|FG000|Participant Flow|Corifollitropin Alfa 100 μg Women/Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10793162|NCT00702624|FG001|Participant Flow|recFSH 150 IU Women/Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
10793163|NCT00702624|FG002|Participant Flow|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
10793164|NCT00702624|FG003|Participant Flow|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
10793165|NCT00702624|OG000|Outcome|Corifollitropin Alfa 100 μg Women|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10802710|NCT02287584|FG005|Participant Flow|DSP-5423P 80mg-to-Flex|"Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.~DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day."
11195650|NCT02159872|EG000|Reported Event|Omacetaxine|"Omacetaxine 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. Participant may continue taking the study drug for up to 24 cycles of treatment.~Omacetaxine: 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle."
11195651|NCT02159898|BG000|Baseline|EndoMAXX EVT|"EndoMAXX EVT Fully Covered Esophageal Stent with Valve~EndoMAXX EVT"
11195652|NCT02159898|BG001|Baseline|EndoMAXX|"EndoMAXX Fully Covered Esophageal Stent~EndoMAXX"
11195653|NCT02159898|BG002|Baseline|Total|Total of all reporting groups
11195654|NCT02159898|FG000|Participant Flow|EndoMAXX EVT|"EndoMAXX EVT Fully Covered Esophageal Stent with Valve~EndoMAXX EVT"
11195655|NCT02159898|FG001|Participant Flow|EndoMAXX|"EndoMAXX Fully Covered Esophageal Stent~EndoMAXX"
10793166|NCT00702624|OG001|Outcome|recFSH 150 IU Women|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
10793167|NCT00702624|OG000|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10793168|NCT00702624|OG001|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
10793169|NCT00702624|OG000|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10793170|NCT00702624|OG000|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
10793171|NCT00702624|OG001|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
10793172|NCT00702624|EG000|Reported Event|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
10802711|NCT02287584|OG000|Outcome|DSP-5423P Placebo|"Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily"
11195656|NCT02159898|OG000|Outcome|EndoMAXX EVT|"EndoMAXX EVT Fully Covered Esophageal Stent with Valve~EndoMAXX EVT"
11195657|NCT02159898|OG001|Outcome|EndoMAXX|"EndoMAXX Fully Covered Esophageal Stent~EndoMAXX"
11195658|NCT02159898|OG000|Outcome|EndoMAXX EVT|EndoMAXX EVT Fully Covered Esophageal Stent with Valve
11195659|NCT02159898|OG001|Outcome|EndoMAXX|EndoMAXX Fully Covered Esophageal Stent
11195660|NCT02159898|EG000|Reported Event|EndoMAXX Endoluminal Valve Technology (EVT)|EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
11195661|NCT02159898|EG001|Reported Event|EndoMAXX|EndoMAXX Fully Covered Esophageal Stent
11195662|NCT02159950|BG000|Baseline|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
11195663|NCT02159950|BG001|Baseline|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
11195664|NCT02159950|BG002|Baseline|Total|Total of all reporting groups
10793173|NCT00702624|EG001|Reported Event|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
10793174|NCT00702624|EG002|Reported Event|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
10793175|NCT00702624|EG003|Reported Event|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
10793176|NCT00702546|BG000|Baseline|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
10793177|NCT00702546|BG001|Baseline|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
11195665|NCT02159950|FG000|Participant Flow|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
11195666|NCT02159950|FG001|Participant Flow|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
11195667|NCT02159950|OG000|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
11195668|NCT02159950|OG001|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
10793178|NCT00702546|BG002|Baseline|Total|Total of all reporting groups
10966718|NCT00888615|BG000|Baseline|Treatment (Paclitaxel, Elesclomol Sodium)|"Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.~Elesclomol Sodium: Given IV~Paclitaxel: Given IV"
11195669|NCT02159950|EG000|Reported Event|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
11195670|NCT02159950|EG001|Reported Event|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
11195671|NCT02159976|BG000|Baseline|Sequential Therapy|"pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)~Pantoprazole~Amoxicillin~Clarithromycin~Metronidazole"
11195672|NCT02159976|BG001|Baseline|Modified Bismuth Quadruple Therapy|"pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)~Pantoprazole~Amoxicillin~Tetracycline~Bismuth"
11195673|NCT02159976|BG002|Baseline|Total|Total of all reporting groups
10793179|NCT00702546|FG000|Participant Flow|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
10793180|NCT00702546|FG001|Participant Flow|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793181|NCT00702546|OG000|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
10793182|NCT00702546|OG001|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793183|NCT00702546|EG000|Reported Event|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
10802712|NCT02287584|OG001|Outcome|DSP-5423P 40mg|"Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily"
11195674|NCT02159976|FG000|Participant Flow|Sequential Therapy|"pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)~Pantoprazole~Amoxicillin~Clarithromycin~Metronidazole"
11195675|NCT02159976|FG001|Participant Flow|Modified Bismuth Quadruple Therapy|"pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)~Pantoprazole~Amoxicillin~Tetracycline~Bismuth"
11195676|NCT02159976|OG000|Outcome|Sequential Therapy|"pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)~Pantoprazole~Amoxicillin~Clarithromycin~Metronidazole"
11195677|NCT02159976|OG001|Outcome|Modified Bismuth Quadruple Therapy|"pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)~Pantoprazole~Amoxicillin~Tetracycline~Bismuth"
11195678|NCT02159976|OG000|Outcome|In Eradication Success Group|functional dyspepsia symptom responses rate in eradication success group
11195679|NCT02159976|OG001|Outcome|In Eradication Failure Group|functional dyspepsia symptom responses rate in eradication failure group
11195680|NCT02159976|EG000|Reported Event|Sequential Therapy|"pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)~Pantoprazole~Amoxicillin~Clarithromycin~Metronidazole"
11195681|NCT02159976|EG001|Reported Event|Modified Bismuth Quadruple Therapy|"pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)~Pantoprazole~Amoxicillin~Tetracycline~Bismuth"
11195682|NCT02160002|BG000|Baseline|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
11195683|NCT02160002|BG001|Baseline|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
10793184|NCT00702546|EG001|Reported Event|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793185|NCT00702520|BG000|Baseline|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
10793186|NCT00702520|BG001|Baseline|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
10793187|NCT00702520|BG002|Baseline|Total|Total of all reporting groups
10793188|NCT00702520|FG000|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
10793189|NCT00702520|FG001|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
10793190|NCT00702520|FG002|Participant Flow|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
10793191|NCT00702520|FG003|Participant Flow|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
10793192|NCT00702520|OG000|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
10793193|NCT00702520|OG001|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
11195684|NCT02160002|BG002|Baseline|Total|Total of all reporting groups
11195685|NCT02160002|FG000|Participant Flow|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
10793194|NCT00702520|OG000|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
10793195|NCT00702520|OG001|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
10793196|NCT00702520|EG000|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
10793197|NCT00702520|EG001|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
10793198|NCT00702520|EG002|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug|Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
10793199|NCT00702520|EG003|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug|Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
11195686|NCT02160002|FG001|Participant Flow|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
11195687|NCT02160002|OG000|Outcome|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
11195688|NCT02160002|OG001|Outcome|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
11195689|NCT02160002|EG000|Reported Event|Lower Weight (1600 Grams)|Weaning from an incubator at a lower weight (1600 grams)
10793200|NCT00702338|BG000|Baseline|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
10793201|NCT00702338|FG000|Participant Flow|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
10793202|NCT00702338|FG001|Participant Flow|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
10793203|NCT00702338|FG002|Participant Flow|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
10793204|NCT00702338|OG000|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
10793205|NCT00702338|OG001|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
10793206|NCT00702338|OG000|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
10793207|NCT00702338|OG000|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers from study P05693 (NCT00697255) were followed for safety and efficacy on the current study according to standard practice.
10793208|NCT00702338|EG000|Reported Event|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
10793209|NCT00702338|EG001|Reported Event|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
10793210|NCT00702273|BG000|Baseline|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793211|NCT00702273|BG001|Baseline|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
11195690|NCT02160002|EG001|Reported Event|Higher Weight (1800 Grams)|Weaning from an incubator at a higher weight (1800 grams)
10793212|NCT00702273|BG002|Baseline|Total|Total of all reporting groups
10793213|NCT00702273|FG000|Participant Flow|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
10793214|NCT00702273|FG001|Participant Flow|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793215|NCT00702273|OG000|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793216|NCT00702273|OG001|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793217|NCT00702273|EG000|Reported Event|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793218|NCT00702273|EG001|Reported Event|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
10793219|NCT00702234|BG000|Baseline|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
10793220|NCT00702234|FG000|Participant Flow|Women/Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
11195691|NCT02160041|BG000|Baseline|BGJ398|BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
11195692|NCT02160041|FG000|Participant Flow|BGJ398|BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
10793221|NCT00702234|FG001|Participant Flow|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
10793222|NCT00702234|OG000|Outcome|Women - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
10793223|NCT00702234|OG000|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
10793224|NCT00702234|OG000|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
10793225|NCT00702234|EG000|Reported Event|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
10793226|NCT00702234|EG001|Reported Event|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
10793227|NCT00697255|BG000|Baseline|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793228|NCT00697255|BG001|Baseline|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793229|NCT00697255|BG002|Baseline|Total|Total of all reporting groups
10793230|NCT00697255|FG000|Participant Flow|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
11195693|NCT02160041|OG000|Outcome|BGJ398|BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
11195694|NCT02160041|EG000|Reported Event|BGJ398|BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
11195695|NCT02160145|BG000|Baseline|Tolvaptan|"Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
10793231|NCT00697255|FG001|Participant Flow|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793232|NCT00697255|OG000|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793233|NCT00697255|OG001|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793234|NCT00697255|EG000|Reported Event|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793235|NCT00697255|EG001|Reported Event|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
10793236|NCT00696878|BG000|Baseline|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
10793237|NCT00696878|FG000|Participant Flow|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
10793238|NCT00696878|OG000|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
11195696|NCT02160145|BG001|Baseline|Placebo|"Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
11195697|NCT02160145|BG002|Baseline|Total Title|
11195698|NCT02160145|FG000|Participant Flow|All Subjects Prerandomization|"Following screening, the single-blind prerandomization period (Day -42 to Day -1) consisted of:~Placebo Run-in: All subjects received a daily split-dose of placebo (0/0 milligrams [mg]) in a form identical to 15/15 mg tolvaptan split-dose for 1 week.~Tolvaptan Titration: Over 2 weeks all subjects received a split-dose of 30/15 mg (2 x 15mg tablets upon waking, then 1 x 15 mg tablet 8-9 hours later) which was titrated up every 3-4 days to 45/15 mg, then 60/30 mg, and up to a maximum dose of 90/30 mg.~Tolvaptan Run-in: Eligible subjects who tolerated at least 60/30 mg tolvaptan during titration entered the 3-week run-in period and continued on a stable dose of 60/30 mg or 90/30 mg tolvaptan to confirm eligibility and establish prerandomization baseline."
11195699|NCT02160145|FG001|Participant Flow|Tolvaptan|"Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
11195700|NCT02160145|FG002|Participant Flow|Placebo|"Double-blind Randomized Treatment Period (Day 0 to Month 12):~Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
11195701|NCT02160145|OG000|Outcome|Tolvaptan|"Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
11195702|NCT02160145|OG001|Outcome|Placebo|"Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.~Follow-up Period: A 3-week final follow-up for efficacy analysis."
11195703|NCT02160145|EG000|Reported Event|Tolvaptan (Single-blind Treatment Period)|The secondary safety population consisted of all subjects who took at least one dose of tolvaptan during the tolvaptan titration/run-in periods.
11195704|NCT02160145|EG001|Reported Event|Tolvaptan (Double-blind Treatment Period)|The tolvaptan primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of tolvaptan after randomization.
11195705|NCT02160145|EG002|Reported Event|Placebo (Double-blind Treatment Period)|The placebo primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of placebo after randomization.
11195706|NCT02160288|BG000|Baseline|Botulinum Toxin-A|"Patients will receive Botulinum Toxin-A (Botox) injected in the puborectalis muscle and external anal sphincter. We will use 100 units of Botox, a dose with a good safety profile that has been proven to work in previous studies performed in adults.~Botulinum Toxin-A: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL"
11195707|NCT02160288|BG001|Baseline|Normal Saline|"Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.~Normal Saline: Dispensed in a 5 cc syringe"
11195708|NCT02160288|BG002|Baseline|Total|Total of all reporting groups
11195709|NCT02160288|FG000|Participant Flow|Botulinum Toxin-A|"Patients will receive Botulinum Toxin-A (Botox) injected in the puborectalis muscle and external anal sphincter. We will use 100 units of Botox, a dose with a good safety profile that has been proven to work in previous studies performed in adults.~Botulinum Toxin-A: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL"
11195710|NCT02160288|FG001|Participant Flow|Normal Saline|"Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.~Normal Saline: Dispensed in a 5 cc syringe"
11195711|NCT02160288|OG000|Outcome|Botulinum Toxin-A|"Patients will receive Botulinum Toxin-A (Botox) injected in the puborectalis muscle and external anal sphincter. We will use 100 units of Botox, a dose with a good safety profile that has been proven to work in previous studies performed in adults.~Botulinum Toxin-A: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL"
11195712|NCT02160288|OG001|Outcome|Normal Saline|"Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.~Normal Saline: Dispensed in a 5 cc syringe"
11195713|NCT02160288|EG000|Reported Event|Botulinum Toxin-A|"Patients will receive Botulinum Toxin-A (Botox) injected in the puborectalis muscle and external anal sphincter. We will use 100 units of Botox, a dose with a good safety profile that has been proven to work in previous studies performed in adults.~Botulinum Toxin-A: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL"
11195714|NCT02160288|EG001|Reported Event|Normal Saline|"Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.~Normal Saline: Dispensed in a 5 cc syringe"
11195715|NCT02160314|BG000|Baseline|Pad Control|"absorbent pad control~Absorbent pad"
11195716|NCT02160314|BG001|Baseline|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
11195717|NCT02160314|BG002|Baseline|Total|Total of all reporting groups
11195718|NCT02160314|FG000|Participant Flow|Pad Control|absorbent pad control
11195719|NCT02160314|FG001|Participant Flow|Pessary|pessary: disposable, single-use
11195720|NCT02160314|OG000|Outcome|Pad Control|"absorbent pad control~Absorbent pad"
11195721|NCT02160314|OG001|Outcome|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
11195722|NCT02160314|EG000|Reported Event|Pad Control|absorbent pad control
11195723|NCT02160314|EG001|Reported Event|Pessary|disposable, single-use pessary
11195724|NCT02160535|BG000|Baseline|Treatment With OnabotulinumtoxinA|"OnabotulinumtoxinA~OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache"
11195725|NCT02160535|FG000|Participant Flow|Treatment With OnabotulinumtoxinA|"OnabotulinumtoxinA~OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache"
11195726|NCT02160535|OG000|Outcome|Treatment With OnabotulinumtoxinA|"OnabotulinumtoxinA~OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache"
11195727|NCT02160535|EG000|Reported Event|Treatment With OnabotulinumtoxinA|"OnabotulinumtoxinA~OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache"
11195728|NCT02160626|BG000|Baseline|A-101 Vehicle|"A-101 Vehicle (placebo) Topical Solution~A-101 Vehicle: Placebo control"
11195729|NCT02160626|BG001|Baseline|A-101 (40%) Topical Solution|"A-101 (40%) Topical Solution - high dose~A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose"
11195730|NCT02160626|BG002|Baseline|A-101 (32.5%) Topical Solution|"A-101 (32.5%) Topical Solution - low dose~A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose"
11195731|NCT02160626|BG003|Baseline|Total|Total of all reporting groups
11195732|NCT02160626|FG000|Participant Flow|A-101 Vehicle|"A-101 Vehicle (placebo) Topical Solution~A-101 Vehicle: Placebo control"
11195733|NCT02160626|FG001|Participant Flow|A-101 (40%) Topical Solution|"A-101 (40%) Topical Solution - high dose~A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose"
11195734|NCT02160626|FG002|Participant Flow|A-101 (32.5%) Topical Solution|"A-101 (32.5%) Topical Solution - low dose~A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose"
10793239|NCT00696878|EG000|Reported Event|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
10793240|NCT00696800|BG000|Baseline|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793241|NCT00696800|BG001|Baseline|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793242|NCT00696800|BG002|Baseline|Total|Total of all reporting groups
10793243|NCT00696800|FG000|Participant Flow|150 µg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793244|NCT00696800|FG001|Participant Flow|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793245|NCT00696800|OG000|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
11195735|NCT02160626|OG000|Outcome|A-101 Vehicle|"A-101 Vehicle (placebo) Topical Solution~A-101 Vehicle: Placebo control"
11195736|NCT02160626|OG001|Outcome|A-101 (32.5%) Topical Solution|"A-101 (32.5%) Topical Solution - low dose~A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose"
11195737|NCT02160626|OG002|Outcome|A-101 (40%) Topical Solution|"A-101 (40%) Topical Solution - high dose~A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose"
10793246|NCT00696800|OG001|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793247|NCT00696800|EG000|Reported Event|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
10793248|NCT00696800|EG001|Reported Event|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
11195738|NCT02160626|OG001|Outcome|A-101 (32.5%) Topical Solution|"A-101 (32.5%) Topical Solution - low dose~A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose"
11195739|NCT02160626|OG002|Outcome|A-101 (40%) Topical Solution|"A-101 (40%) Topical Solution - high dose~A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose"
11195740|NCT02160626|EG000|Reported Event|A-101 Vehicle|"A-101 Vehicle (placebo) Topical Solution~A-101 Vehicle: Placebo control"
11195741|NCT02160626|EG001|Reported Event|A-101 (32.5%) Topical Solution|"A-101 (32.5%) Topical Solution - low dose~A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose"
11195742|NCT02160626|EG002|Reported Event|A-101 (40%) Topical Solution|"A-101 (40%) Topical Solution - high dose~A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose"
11195743|NCT02160730|BG000|Baseline|R-roscovitine|• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.
11195744|NCT02160730|FG000|Participant Flow|R-roscovitine|• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.
10793249|NCT00616967|BG000|Baseline|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793250|NCT00616967|BG001|Baseline|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793251|NCT00616967|BG002|Baseline|Total|Total of all reporting groups
10793252|NCT00616967|FG000|Participant Flow|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV vorinostat: Given orally"
10793253|NCT00616967|FG001|Participant Flow|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793254|NCT00616967|FG002|Participant Flow|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793255|NCT00616967|OG000|Outcome|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793256|NCT00616967|OG001|Outcome|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793257|NCT00616967|OG000|Outcome|Run-in Phase (Arm 0)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793258|NCT00616967|OG001|Outcome|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793259|NCT00616967|OG002|Outcome|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793260|NCT00616967|OG000|Outcome|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793261|NCT00616967|OG001|Outcome|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793262|NCT00616967|OG000|Outcome|Responders|Pooled data from participants who received a pathologic complete response across arms.
10793263|NCT00616967|OG001|Outcome|Non-Responders|Pooled data from participants who did not receive a pathologic complete response across arms.
10793264|NCT00616967|OG000|Outcome|Combined Arm I and Arm II|Tissue and serum samples from all participants in the actual study (combination of both arms).
10793265|NCT00616967|OG000|Outcome|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV vorinostat: Given orally"
10793266|NCT00616967|OG001|Outcome|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
11195745|NCT02160730|OG000|Outcome|R-roscovitine|"• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.~R-roscovitine: See Arm Description"
11195746|NCT02160730|OG000|Outcome|R-roscovitine|• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.
11195747|NCT02160730|EG000|Reported Event|R-roscovitine|• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.
11195748|NCT02160782|BG000|Baseline|Open-label Period: Maralixibat|All participants received MRX at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.
11337727|NCT03592745|OG001|Outcome|Sham tVNS + Robotic Arm Therapy|"Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control."
10793267|NCT00616967|OG002|Outcome|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
11337728|NCT03592745|EG000|Reported Event|Active tVNS + Robotic Arm Therapy|"Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear."
11337729|NCT03592745|EG001|Reported Event|Sham tVNS + Robotic Arm Therapy|"Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.~Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control."
11337730|NCT03593200|BG000|Baseline|Pegcetacoplan 270 mg/Day|Subjects received SC infusions of pegcetacoplan 270 mg/day up to Day 364. Intrasubject dose escalation up to a dosage of 360 mg/day was permitted if clinically indicated.
11337731|NCT03593200|FG000|Participant Flow|Pegcetacoplan 270 mg/Day|Subjects received subcutaneous (SC) infusions of pegcetacoplan 270 milligrams (mg)/day up to Day 364. Intrasubject dose escalation up to a dosage of 360 mg/day was permitted if clinically indicated.
11337732|NCT03593200|OG000|Outcome|Pegcetacoplan 270 mg/Day|Subjects received SC infusions of pegcetacoplan 270 mg/day up to Day 364. Intrasubject dose escalation up to a dosage of 360 mg/day was permitted if clinically indicated.
11337733|NCT03593200|EG000|Reported Event|Pegcetacoplan 270 mg/Day|Subjects received SC infusions of pegcetacoplan 270 mg/day up to Day 364. Intrasubject dose escalation up to a dosage of 360 mg/day was permitted if clinically indicated.
11337734|NCT03593538|BG000|Baseline|Low Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day~Metformin: Metformin capsule~Placebo: Sucrose filler in gel capsules"
11337735|NCT03593538|BG001|Baseline|High Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day~Metformin: Metformin capsule"
11337736|NCT03593538|BG002|Baseline|Placebo|"Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day~Placebo: Sucrose filler in gel capsules"
11337737|NCT03593538|BG003|Baseline|Total|Total of all reporting groups
11337738|NCT03593538|FG000|Participant Flow|Low Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day~Metformin: Metformin capsule~Placebo: Sucrose filler in gel capsules"
11337739|NCT03593538|FG001|Participant Flow|High Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day~Metformin: Metformin capsule"
11337740|NCT03593538|FG002|Participant Flow|Placebo|"Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day~Placebo: Sucrose filler in gel capsules"
11337741|NCT03593538|OG000|Outcome|Low Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day~Metformin: Metformin capsule~Placebo: Sucrose filler in gel capsules"
11337742|NCT03593538|OG001|Outcome|High Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day~Metformin: Metformin capsule"
11337743|NCT03593538|OG002|Outcome|Placebo|"Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day~Placebo: Sucrose filler in gel capsules"
11337744|NCT03593538|EG000|Reported Event|Low Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day~Metformin: Metformin capsule~Placebo: Sucrose filler in gel capsules"
11337745|NCT03593538|EG001|Reported Event|High Dose Metformin|"Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day~Metformin: Metformin capsule"
11337746|NCT03593538|EG002|Reported Event|Placebo|"Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day~Placebo: Sucrose filler in gel capsules"
11337747|NCT03593681|BG000|Baseline|Cytuity Cytological Evaluation|Subjects from whom a signed informed consent form was obtained.
11337748|NCT03593681|FG000|Participant Flow|Cytuity Cytological Evaluation|Those subjects enrolled in the study, with hysteroscope placed, ostia visualized, and adequate Cytuity cell sample collected.
11337749|NCT03593681|OG000|Outcome|Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease|The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.
11337750|NCT03593681|OG001|Outcome|Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease|The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.
10793268|NCT00616967|EG000|Reported Event|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally~Events summarized in this arm are those that met 5% reporting threshold in Arms I and II."
10793269|NCT00616967|EG001|Reported Event|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
10793270|NCT00616967|EG002|Reported Event|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
10793271|NCT00461032|BG000|Baseline|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
10793272|NCT00461032|BG001|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
10793273|NCT00461032|BG002|Baseline|Total|Total of all reporting groups
10793274|NCT00461032|FG000|Participant Flow|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
10793275|NCT00461032|FG001|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
10793276|NCT00461032|OG000|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
10793277|NCT00461032|OG001|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
10793278|NCT00461032|EG000|Reported Event|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
10793279|NCT00461032|EG001|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
10793280|NCT00442338|BG000|Baseline|Montelukast 7 mg|Montelukast 7 mg IV Administration
10793281|NCT00442338|BG001|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793282|NCT00442338|BG002|Baseline|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
10793283|NCT00442338|BG003|Baseline|Total|Total of all reporting groups
10793284|NCT00442338|FG000|Participant Flow|Montelukast 7 mg|Montelukast 7 mg IV Administration
10793285|NCT00442338|FG001|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793286|NCT00442338|FG002|Participant Flow|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
10793287|NCT00442338|OG000|Outcome|Montelukast 7 mg|Montelukast 7 mg IV Administration
10793288|NCT00442338|OG001|Outcome|Montelukast 14 mg|Montelukast 14 mg IV Administration
10793289|NCT00442338|OG002|Outcome|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
10793290|NCT00442338|EG000|Reported Event|Montelukast 7 mg|Montelukast 7 mg IV Administration
10793291|NCT00442338|EG001|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793292|NCT00442338|EG002|Reported Event|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
10793293|NCT00289874|BG000|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
10793294|NCT00289874|BG001|Baseline|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
10793295|NCT00289874|BG002|Baseline|Total|Total of all reporting groups
10793296|NCT00289874|FG000|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
10793297|NCT00289874|FG001|Participant Flow|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
10793298|NCT00289874|OG000|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
10793299|NCT00289874|OG001|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
10793300|NCT00289874|EG000|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
10793301|NCT00289874|EG001|Reported Event|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
10793302|NCT00250458|BG000|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
10793303|NCT00250458|BG001|Baseline|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
10793304|NCT00250458|BG002|Baseline|Total|Total of all reporting groups
10793305|NCT00250458|FG000|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
10793306|NCT00250458|FG001|Participant Flow|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
10793307|NCT00250458|OG000|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
10793308|NCT00250458|OG001|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
10793309|NCT00250458|EG000|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
10793310|NCT00250458|EG001|Reported Event|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
10793311|NCT00245570|BG000|Baseline|Overall Study Population|All randomized patients
10802713|NCT02287584|OG002|Outcome|DSP-5423P 80mg|"Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily"
11383284|NCT02381652|FG002|Participant Flow|Cingal/Saline|"Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383285|NCT02381652|OG000|Outcome|Cingal 13-02 Adverse Events|All adverse events that occurred in Cingal 13-02 for 6 weeks post-injection, regardless if considered related to the study injection or not.
11383286|NCT02381652|EG000|Reported Event|Cingal/Cingal|"Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383287|NCT02381652|EG001|Reported Event|Cingal/Monovisc|"Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383288|NCT02381652|EG002|Reported Event|Cingal/Saline|"Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.~Cingal: Injection into the knee"
11383289|NCT02367794|BG000|Baseline|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383290|NCT02367794|BG001|Baseline|Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383291|NCT02367794|BG002|Baseline|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383292|NCT02367794|BG003|Baseline|Total|Total of all reporting groups
11383293|NCT02367794|FG000|Participant Flow|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383294|NCT02367794|FG001|Participant Flow|Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383295|NCT02367794|FG002|Participant Flow|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383296|NCT02367794|OG000|Outcome|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383297|NCT02367794|OG001|Outcome|Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
10793312|NCT00245570|FG000|Participant Flow|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
10793313|NCT00245570|FG001|Participant Flow|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
10793314|NCT00245570|FG002|Participant Flow|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
10793315|NCT00245570|FG003|Participant Flow|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
10793316|NCT00245570|FG004|Participant Flow|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
10793317|NCT00245570|FG005|Participant Flow|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
10793318|NCT00245570|OG000|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
11202219|NCT02206152|OG001|Outcome|Treatment With N-Acetyl Cysteine|"N-acetyl cysteine IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp~N-acetyl cysteine: N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp"
11202220|NCT02206152|EG000|Reported Event|Placebo|"Normal Saline IV infusion given during a controlled hyperinsulinemic hypoglycemic insulin clamp~Placebo"
11202221|NCT02206152|EG001|Reported Event|Treatment With N-Acetyl Cysteine|"N-acetyl cysteine IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp~N-acetyl cysteine: N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp"
11202222|NCT02206217|BG000|Baseline|Single Vision Spectacle Lens|Single vision lens with power for correcting distance refraction.
11337751|NCT03593681|OG000|Outcome|PPV - Proportion of True Positive Results for Fallopian Tube Involvement|The proportion of positive Cytuity cell samples that came from a fallopian tube found to have histology positive for malignancy and/or a corresponding ovary found to have histology positive for malignancy
11337752|NCT03593681|OG001|Outcome|NPV - Proportion of True Negative Results for Fallopian Tube Involvement|The proportion of negative Cytuity cell samples that came from a fallopian tube found to have histology negative for malignancy and a corresponding ovary found to have histology negative for malignancy
11337753|NCT03593681|OG002|Outcome|Diagnostic Accuracy - Proportion of Accurate Diagnoses|The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
11337754|NCT03593681|OG000|Outcome|Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease|The number of true positive Cytuity cell samples divided by the number of true positive and the number of false negatives
11337755|NCT03593681|OG001|Outcome|Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease|The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives
11337756|NCT03593681|OG002|Outcome|PPV - Proportion of True Positive Results for Fallopian Tube Pathology|The proportion of positive Cytuity cell samples that came from a fallopian tube also found to have histology positive for malignancy
11337757|NCT03593681|OG003|Outcome|NPV - Proportion of True Negative Results for Fallopian Tube Pathology|The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy
11337758|NCT03593681|OG004|Outcome|Diagnostic Accuracy - Proportion of Accurate Diagnoses|The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
11337759|NCT03593681|OG000|Outcome|Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease|Number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives
11337760|NCT03593681|OG002|Outcome|PPV - Proportion of True Positive Results for Ovary Pathology for Epithelial Malignancy|The proportion of positive Cytuity cell samples that came from a fallopian tube adjacent to a corresponding ovary found to have histology positive for malignancy
11337761|NCT03593681|OG003|Outcome|NPV - Proportion of True Negatives for Ovary Pathology for Epithelial Malignancy|The proportion of negative Cytuity cell samples that came from a fallopian tube adjacent to a corresponding ovary found to have histology truly negative for malignancy
11337762|NCT03593681|OG000|Outcome|Sensitivity - Subjects in Which the Cytuity Correctly Identified the Presence of Disease|Number of subjects with true positive Cytuity cell samples divided by the number of subjects with true positives and the number of subjects with false negatives
11337763|NCT03593681|OG001|Outcome|Specificity - Subjects in Which the Cytuity Correctly Identified the Absence of Disease|The number of subjects with true negative Cytuity cell samples divided by the number of subjects with true negatives and the number of subjects with false positives
11337764|NCT03593681|OG002|Outcome|PPV - True Positive Results for Fallopian Tube Involvement on Subject Level|The number of subjects with a positive Cytuity cell sample and a fallopian tube and/or corresponding ovary with histology positive for malignancy
11337765|NCT03593681|OG003|Outcome|NPV - True Negative Results for Fallopian Tube Involvement on Subject Level|The number of subjects with a negative Cytuity cell sample and a fallopian tube and corresponding ovary with histology negative for malignancy
11337766|NCT03593681|OG004|Outcome|Diagnostic Accuracy - Subjects With Accurate Diagnoses|The number of subjects with a Cytuity cell sample result that conformed to the correct diagnosis on a subject level as determined by the surgical histology results
11337767|NCT03593681|EG000|Reported Event|Treated Subjects|Subjects who signed the informed consent and had hysteroscope placement attempted
11337768|NCT03593876|BG000|Baseline|Strategy Training|"Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.~Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol."
11337769|NCT03593876|FG000|Participant Flow|Strategy Training|"Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.~Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol."
11337770|NCT03593876|OG000|Outcome|Strategy Training|"Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.~Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol."
11337771|NCT03593876|EG000|Reported Event|Strategy Training|"Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.~Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol."
10793319|NCT00245570|OG001|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
10793320|NCT00245570|OG002|Outcome|Placebo|All Placebo patients from all Treatment Periods.
10793321|NCT00245570|EG000|Reported Event|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
10793322|NCT00245570|EG001|Reported Event|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
10793323|NCT00245570|EG002|Reported Event|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
10793324|NCT00245570|EG003|Reported Event|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
10793325|NCT00245570|EG004|Reported Event|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
10793326|NCT00245570|EG005|Reported Event|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
10793327|NCT00229970|BG000|Baseline|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
10793328|NCT00229970|BG001|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793329|NCT00229970|BG002|Baseline|Placebo|Placebo Intravenous Administration
10793330|NCT00229970|BG003|Baseline|Total|Total of all reporting groups
10793331|NCT00229970|FG000|Participant Flow|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
10793332|NCT00229970|FG001|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793333|NCT00229970|FG002|Participant Flow|Placebo|Placebo Intravenous Administration
10793334|NCT00229970|OG000|Outcome|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
10793335|NCT00229970|OG001|Outcome|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
11337791|NCT03594227|BG002|Baseline|ATI-501 800mg BID Dosing|"ATI-501 800mg BID dosing - oral administration~ATI-501 800mg BID dosing: ATI-501 high dose for oral administration"
10793336|NCT00229970|OG002|Outcome|Placebo|Placebo Intravenous Administration
10793337|NCT00229970|EG000|Reported Event|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
11337792|NCT03594227|BG003|Baseline|Placebo|Placebo: BID - oral administration
10793338|NCT00229970|EG001|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
10793339|NCT00229970|EG002|Reported Event|Placebo|Placebo Intravenous Administration
10793340|NCT00092131|BG000|Baseline|Overall Study Population|All randomized patients
10793341|NCT00092131|FG000|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
10793342|NCT00092131|FG001|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
10793343|NCT00092131|OG000|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
10793344|NCT00092131|OG001|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
10793345|NCT00092131|EG000|Reported Event|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
10793346|NCT00092131|EG001|Reported Event|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
10793347|NCT00092118|BG000|Baseline|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
10793348|NCT00092118|BG001|Baseline|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
11337793|NCT03594227|BG004|Baseline|Total|Total of all reporting groups
10793349|NCT00092118|BG002|Baseline|Total|Total of all reporting groups
10793350|NCT00092118|FG000|Participant Flow|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
10793351|NCT00092118|FG001|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
10793352|NCT00092118|OG000|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
10793353|NCT00092118|OG001|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
10793354|NCT00092118|EG000|Reported Event|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
10793355|NCT00092118|EG001|Reported Event|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
10793356|NCT00090142|BG000|Baseline|Overall Study Population|All randomized patients
10793357|NCT00090142|FG000|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|"A montelukast 10-mg tablet (Treatment Period I) was taken orally in the~morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast~matching-image placebo tablet (Treatment Period II) was taken orally in the morning as a single witnessed~dose."
10793358|NCT00090142|FG001|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|"A montelukast matching-image placebo tablet (Treatment Period I) was taken~orally in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a~montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning as a single witnessed dose."
10793359|NCT00090142|OG000|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
10793360|NCT00090142|OG001|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
10793361|NCT00090142|EG000|Reported Event|Montelukast 10 mg|
10793362|NCT00090142|EG001|Reported Event|Placebo|
10793363|NCT00043108|BG000|Baseline|Treatment|"Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)~carboplatin~paclitaxel~conventional surgery~radiation therapy"
10793364|NCT00043108|FG000|Participant Flow|Treatment|"Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)~carboplatin~paclitaxel~conventional surgery~radiation therapy"
10793365|NCT00043108|OG000|Outcome|Treatment|"Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)~carboplatin~paclitaxel~conventional surgery~radiation therapy"
10793366|NCT00043108|EG000|Reported Event|Treatment|"Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)~carboplatin~paclitaxel~conventional surgery~radiation therapy"
10802714|NCT02287584|OG000|Outcome|DSP-5423P Placebo-to-Flex|Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
10802715|NCT02287584|OG001|Outcome|DSP-5423P 40 Mg-to-Flex|Percutaneous Subjects received DSP-5423P 40 mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
10802716|NCT02287584|OG002|Outcome|DSP-5423P 80 Mg-to-Flex|Percutaneous Subjects received DSP-5423P 80 mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
10802717|NCT02287584|EG000|Reported Event|DSP-5423P Placebo|"Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily"
11337794|NCT03594227|FG000|Participant Flow|ATI-501 400mg BID Dosing|"ATI-501 400mg BID dosing - oral administration~ATI-501 400mg BID dosing: ATI-501 oral low dose"
11337795|NCT03594227|FG001|Participant Flow|ATI-501 600mg BID Dosing|"ATI-501 600mg BID dosing - oral administration~ATI-501 600mg BID dosing: ATI-501 oral low dose"
10793367|NCT04771013|BG000|Baseline|Daily Oral Dose of Thymic Peptides|"Patients will receive a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment, for up to 20 days or until medical discharge.~Thymic peptides: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach."
10793368|NCT04771013|BG001|Baseline|Historic Control Group|"A participant-level comparison based on a control group by propensity score matching from registry data was performed.~For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020.~Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin)."
10793369|NCT04771013|BG002|Baseline|Total|Total of all reporting groups
10793370|NCT04771013|FG000|Participant Flow|Daily Oral Dose of Thymic Peptides|"Patients will receive a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment, for up to 20 days or until medical discharge.~Thymic peptides: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach."
10793371|NCT04771013|FG001|Participant Flow|Historic Control Group|"A participant-level comparison based on a control group by propensity score matching from registry data was performed.~For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020.~Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin)."
10793372|NCT04771013|OG000|Outcome|Daily Oral Dose of Thymic Peptides|"Patients will receive a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment, for up to 20 days or until medical discharge.~Thymic peptides: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach."
10793373|NCT04771013|OG001|Outcome|Historic Control Group|"A participant-level comparison based on a control group by propensity score matching from registry data was performed.~For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020.~Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin)."
10793374|NCT04771013|EG000|Reported Event|Daily Oral Dose of Thymic Peptides|"Patients will receive a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment, for up to 20 days or until medical discharge.~Thymic peptides: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach."
10793375|NCT04771013|EG001|Reported Event|Historic Control Group|"A participant-level comparison based on a control group by propensity score matching from registry data was performed.~For the comparison group, registry data from June 2020 to February 2021 was considered, as standardization of Stage IIB therapeutic management to its current guideline in Honduras occurred on May 2020.~Although highly controversial among the Honduran scientific community, guidelines approved by the Honduran Ministry of Health for the treatment of Covid-19 include the use of ivermectin, azithromycin, zinc, hydroxychloroquine or chloroquine, acetaminophen, ibuprofen, and oral disinfectants (sodium hypochlorite, hypochlorous acid, hydrogen peroxide, among others) for the initial phases of disease progression. On top of these, therapeutic options for patients presenting with pulmonary compromise before or during hospitalization for phase IIb include colchicine, dexamethasone or methylprednisolone, and anticoagulation (rivaroxaban, apixaban, heparin, or enoxaparin)."
10793376|NCT04497987|BG000|Baseline|Placebo|Participants received single IV infusion of Placebo.
10793377|NCT04497987|BG001|Baseline|4200 mg Bamlanivimab|Participants received single IV infusion of 4200 mg bamlanivimab.
10793378|NCT04497987|BG002|Baseline|Total|Total of all reporting groups
10793379|NCT04497987|FG000|Participant Flow|Placebo|Participants received single IV infusion of Placebo.
10793380|NCT04497987|FG001|Participant Flow|4200 mg Bamlanivimab|Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
11241192|NCT02485158|EG000|Reported Event|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
10793381|NCT04497987|OG000|Outcome|Placebo|Participants received single IV infusion of Placebo.
10793382|NCT04497987|OG001|Outcome|4200mg Bamlanivimab|Participants received single IV infusion of 4200mg bamlanivimab.
10793383|NCT04497987|OG000|Outcome|4200mg Bamlanivimab|Participants received single IV infusion of 4200mg bamlanivimab.
10793384|NCT04497987|EG000|Reported Event|Placebo|Participants received single IV infusion of Placebo.
10793385|NCT04497987|EG001|Reported Event|4200mg Bamlanivimab|Participants received single IV infusion of 4200mg bamlanivimab.
10802718|NCT02287584|EG001|Reported Event|DSP-5423P 40mg|"Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily"
10802719|NCT02287584|EG002|Reported Event|DSP-5423P 80mg|"Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.~DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily"
10802720|NCT02287584|EG003|Reported Event|DSP-5423P Placebo-to-Flex|"Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.~DSP-5423P Placebo-to-Flex: DSP-5423P Placebo:~DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily~DSP-5423P Flex:~DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily"
10802721|NCT02287584|EG004|Reported Event|DSP-5423P 40mg-to-Flex|"Percutaneous Subjects received DSP-5423P 40mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.~DSP-5423P Active-to-Flex: DSP-5423P Active:~DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily~DSP-5423P Flex:~DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily"
11202223|NCT02206217|BG001|Baseline|Multiple-Segment Spectacle Lens|"A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.~Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression."
10802722|NCT02287584|EG005|Reported Event|DSP-5423P 80mg-to-Flex|Percutaneous Subjects received DSP-5423P 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
10802723|NCT02178566|BG000|Baseline|Inhaled Treprostinil Placebo|A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .
10802724|NCT02178566|BG001|Baseline|Inhaled Treprostinil|A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
10802725|NCT02178566|BG002|Baseline|Total|Total of all reporting groups
10802726|NCT02178566|FG000|Participant Flow|Inhaled Treprostinil Placebo|A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .
10802727|NCT02178566|FG001|Participant Flow|Inhaled Treprostinil|A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
10802728|NCT02178566|OG000|Outcome|Inhaled Treprostinil Placebo|"A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .~No patient completed"
10802729|NCT02178566|OG001|Outcome|Inhaled Treprostinil|"A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .~no patient completed"
11202224|NCT02206217|BG002|Baseline|Total|Total of all reporting groups
11202225|NCT02206217|FG000|Participant Flow|Single Vision Spectacle Lens|Single vision lens with power for correcting distance refraction.
11241193|NCT02485301|BG000|Baseline|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
11383298|NCT02367794|OG002|Outcome|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383299|NCT02367794|OG000|Outcome|Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383300|NCT02367794|OG001|Outcome|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383301|NCT02367794|OG000|Outcome|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383302|NCT02367794|OG001|Outcome|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383303|NCT02367794|OG002|Outcome|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383304|NCT02367794|EG000|Reported Event|Arm C: Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care.
11383305|NCT02367794|EG001|Reported Event|Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383306|NCT02367794|EG002|Reported Event|Arm A: Atezolizumab + Paclitaxel + Carboplatin|The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant.
11383307|NCT02363998|BG000|Baseline|OL: Lofexidine HCl|"Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.~Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested."
11383308|NCT02363998|FG000|Participant Flow|OL: Lofexidine HCl|"Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.~Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested."
11241194|NCT02485301|BG001|Baseline|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
10793386|NCT04198584|BG000|Baseline|VC-CBCS Intervention|The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy patient Workbook and audio-recorded relaxation techniques.
10793387|NCT04198584|BG001|Baseline|Standard of Care (SC)|Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.
10793388|NCT04198584|BG002|Baseline|Total|Total of all reporting groups
10793389|NCT04198584|FG000|Participant Flow|VC-CBCS Intervention|The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that include group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques.
10793390|NCT04198584|FG001|Participant Flow|Standard of Care (SC)|Participants randomized to Standard of Care (SC) received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.
10793391|NCT04198584|OG000|Outcome|All Patients|All patients who were approached for the study.
10793392|NCT04198584|OG000|Outcome|All Participants|All participants who were consented for the study.
10793393|NCT04198584|OG000|Outcome|Standard of Care (SC)|Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
10793394|NCT04198584|OG000|Outcome|VC-CBCS Intervention|The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques.
10793395|NCT04198584|OG000|Outcome|All Enrolled Participants|All participants who were enrolled and completed the study.
10793396|NCT04198584|OG001|Outcome|Standard of Care (SC)|Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
10793397|NCT04198584|OG000|Outcome|VC-CBCS Intervention|"The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques.~VC-CBCS: A 14 module stress management and lifestyle group-based intervention delivered via videoconferencing Webex technology to patients who have had chronic hepatitis C and experience symptoms, stress or lifestyle requirements to promote liver health."
10793398|NCT04198584|EG000|Reported Event|VC-CBCS Intervention|The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques.
10793399|NCT04198584|EG001|Reported Event|Standard of Care (SC)|Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.
10793400|NCT04013932|BG000|Baseline|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients and 6 matched caregivers. The dyads will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10793401|NCT04013932|BG001|Baseline|Control - Standard of Care|Patients will receive the standard of care.
10793402|NCT04013932|BG002|Baseline|Total|Total of all reporting groups
11241195|NCT02485301|BG002|Baseline|Total|Total of all reporting groups
10802730|NCT02178566|EG000|Reported Event|Inhaled Treprostinil Placebo|"A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .~Inhaled Treprostinil: A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients ."
11241196|NCT02485301|FG000|Participant Flow|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
11241197|NCT02485301|FG001|Participant Flow|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
10793403|NCT04013932|FG000|Participant Flow|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients who will also be joined by their caregivers in their sessions. The patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop open to both the patients and their caregivers. Patient-participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks with their caregiver.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10793404|NCT04013932|FG001|Participant Flow|Control - Standard of Care|Patients will receive the standard of care.
10793405|NCT04013932|OG000|Outcome|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients (who attend with a matched caregiver). Participants first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10793406|NCT04013932|OG001|Outcome|Control - Standard of Care|Patients will receive the standard of care.
10793407|NCT04013932|OG000|Outcome|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients (with their matched caregivers). Patients participated in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10793408|NCT04013932|OG000|Outcome|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients (with their matched caregivers). Patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10802731|NCT02178566|EG001|Reported Event|Inhaled Treprostinil|"A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .~Inhaled Treprostinil: A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients ."
11195749|NCT02160782|FG000|Participant Flow|Open-label Period: Maralixibat (LUM001)|"All participants received Maralixibat (LUM001:MRX) at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.~Participants were randomized 1:1 to continue to receive MRX or placebo (Pbo) for 4 weeks between the start of Week 19 and the end of Week 22 (the double-blind, placebo-controlled study drug withdrawal period).~All participants, caregivers, monitors, and study center personnel related to the study, except for the central pharmacist who prepared the study drug, were blinded to the participants' study drug withdrawal period treatment assignment during the randomized withdrawal (RWD) period.~Participants who received placebo during the RWD period returned to MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment.~Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment."
10793409|NCT04013932|EG000|Reported Event|KUPAA Intervention + Standard of Care|"Patients will be assigned to a KUPAA group composed of approximately 6 patients per group (with matched caregivers also attending). Patients first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.~KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components:~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
10793410|NCT04013932|EG001|Reported Event|Control - Standard of Care|Patients will receive the standard of care.
10793411|NCT03840616|BG000|Baseline|Oteseconazole (VT-1161)|600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.
10793412|NCT03840616|BG001|Baseline|Fluconazole / Placebo|150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
10793413|NCT03840616|BG002|Baseline|Total|Total of all reporting groups
10793414|NCT03840616|FG000|Participant Flow|Oteseconazole (VT-1161)|600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.
10793415|NCT03840616|FG001|Participant Flow|Fluconazole / Placebo|150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
10793416|NCT03840616|OG000|Outcome|Oteseconazole (VT-1161)|600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.
10793417|NCT03840616|OG001|Outcome|Fluconazole / Placebo|150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
10793418|NCT03840616|EG000|Reported Event|Oteseconazole (Induction Phase)|600mg oteseconazole on Day 1 and 450mg oteseconazole on Day 2
10793419|NCT03840616|EG001|Reported Event|Oteseconazole (Maintenance Phase)|150mg oteseconazole once weekly for 11 weeks starting on Day 14.
10793420|NCT03840616|EG002|Reported Event|Fluconazole (Induction Phase)|150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1
10793421|NCT03840616|EG003|Reported Event|Placebo (Maintenance Phase)|Placebo once weekly for 11 weeks starting on Day 14.
10793422|NCT03623373|BG000|Baseline|Bendamustine/Rituximab/Acalabrutinib/Cytarabine|"Patients will receive (6) 28 day cycles~Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.~Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard~After Cycle 6, patients will undergo leukapheresis"
11195750|NCT02160782|FG001|Participant Flow|Randomized Withdrawal Period: MRX|Participants continued to receive MRX at 400 μg/kg QD during the RWD period
10793423|NCT03623373|FG000|Participant Flow|Bendamustine/Rituximab/Acalabrutinib/Cytarabine|"Patients will receive (6) 28 day cycles~Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.~Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard~After Cycle 6, patients will undergo leukapheresis"
10793424|NCT03623373|OG000|Outcome|Bendamustine/Rituximab/Acalabrutinib/Cytarabine|"Patients will receive (6) 28 day cycles~Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.~Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard~After Cycle 6, patients will undergo leukapheresis"
11195751|NCT02160782|FG002|Participant Flow|Randomized Withdrawal Period: Placebo|Participants received a corresponding placebo during the RWD period
10793425|NCT03623373|EG000|Reported Event|Bendamustine/Rituximab/Acalabrutinib/Cytarabine|"Patients will receive (6) 28 day cycles~Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.~Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard~After Cycle 6, patients will undergo leukapheresis"
10793426|NCT03581279|BG000|Baseline|EM Present|"All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793427|NCT03581279|BG001|Baseline|No EM Present|"All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793428|NCT03581279|BG002|Baseline|Total|Total of all reporting groups
10802732|NCT02173301|BG000|Baseline|XP23829 400 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period~XP23829 400 mg QD: active dose 1"
11202226|NCT02206217|FG001|Participant Flow|Multiple-Segment Spectacle Lens|"A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.~Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression."
10793429|NCT03581279|FG000|Participant Flow|EM Present|"All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793430|NCT03581279|FG001|Participant Flow|No EM Present|"All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793431|NCT03581279|OG000|Outcome|EM Present|"All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793432|NCT03581279|OG001|Outcome|No EM Present|"All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793433|NCT03581279|EG000|Reported Event|EM Present|"All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793434|NCT03581279|EG001|Reported Event|No EM Present|"All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.~T2Lyme Panel testing: The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples."
10793435|NCT03512210|BG000|Baseline|MINMON 24 Weeks With SOF/VEL 12 Weeks|"Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks~Sofosbuvir/Velpatasvir (SOF/VEL): 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.~Minimal Monitoring (MINMON) Strategy: MINMON Strategy:~No pre-treatment HCV genotyping~Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry~No scheduled on-treatment laboratory monitoring or clinic visits~Remote contact with participants at week 4 and week 22"
10793436|NCT03512210|FG000|Participant Flow|MINMON 24 Weeks With SOF/VEL 12 Weeks|"Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks~Sofosbuvir/Velpatasvir (SOF/VEL): 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.~Minimal Monitoring (MINMON) Strategy: MINMON Strategy:~No pre-treatment HCV genotyping~Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry~No scheduled on-treatment laboratory monitoring or clinic visits~Remote contact with participants at week 4 and week 22"
10793437|NCT03512210|OG000|Outcome|MINMON 24 Weeks With SOF/VEL 12 Weeks|"Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks~Sofosbuvir/Velpatasvir (SOF/VEL): 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.~Minimal Monitoring (MINMON) Strategy: MINMON Strategy:~No pre-treatment HCV genotyping~Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry~No scheduled on-treatment laboratory monitoring or clinic visits~Remote contact with participants at week 4 and week 22"
10793438|NCT03512210|EG000|Reported Event|MINMON 24 Weeks With SOF/VEL 12 Weeks|"Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks~Sofosbuvir/Velpatasvir (SOF/VEL): 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.~Minimal Monitoring (MINMON) Strategy: MINMON Strategy:~No pre-treatment HCV genotyping~Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry~No scheduled on-treatment laboratory monitoring or clinic visits~Remote contact with participants at week 4 and week 22"
11195752|NCT02160782|FG003|Participant Flow|After Randomized Withdrawal Period: Maralixibat|Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.
11195753|NCT02160782|FG004|Participant Flow|Long-term Extension Period: Maralixibat|The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.
11195754|NCT02160782|OG000|Outcome|Randomized Withdrawal Period: MRX|Participants continued to receive MRX at 400 μg/kg QD during the RWD period
11195755|NCT02160782|OG001|Outcome|Randomized Withdrawal Period: Placebo|Participants received a corresponding placebo during the RWD period
11195756|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in fasting sBA levels
11195757|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in fasting sBA levels
11195758|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ItchRO(Obs) and ItchRO(Pt)
11195759|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ItchRO(Obs) and ItchRO(Pt)
11202227|NCT02206217|OG000|Outcome|SV Group|single vision spectacle lens
10793439|NCT03506412|BG000|Baseline|Low Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP levels less than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793440|NCT03506412|BG001|Baseline|High Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP greater than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793441|NCT03506412|BG002|Baseline|Total|Total of all reporting groups
10793442|NCT03506412|FG000|Participant Flow|Low Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP levels less than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49 Mg-51 mg will be given twice daily orally for 5 weeks"
10793443|NCT03506412|FG001|Participant Flow|High Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP greater than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49 Mg-51 mg will be given twice daily orally for 5 weeks"
10793444|NCT03506412|OG000|Outcome|Low Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP levels less than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793445|NCT03506412|OG001|Outcome|High Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP greater than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793446|NCT03506412|EG000|Reported Event|Low Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP levels less than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793447|NCT03506412|EG001|Reported Event|High Serum Neprilysin (sNEP) Levels|"Subjects with baseline sNEP greater than or equal to 0.9 ng/ml~Entresto™ 49Mg-51 mg tablet: Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks"
10793448|NCT03420768|BG000|Baseline|BMS-986263 45 mg QW (Once Weekly)|BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793449|NCT03420768|BG001|Baseline|BMS-986263 90 mg QW (Once Weekly)|BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793450|NCT03420768|BG002|Baseline|Placebo QW (Once Weekly)|Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793451|NCT03420768|BG003|Baseline|Total|Total of all reporting groups
10793452|NCT03420768|FG000|Participant Flow|BMS-986263 45 mg QW (Once Weekly)|BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793453|NCT03420768|FG001|Participant Flow|BMS-986263 90 mg QW (Once Weekly)|BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793454|NCT03420768|FG002|Participant Flow|Placebo QW (Once Weekly)|Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793455|NCT03420768|OG000|Outcome|BMS-986263 45 mg QW (Once Weekly)|BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793456|NCT03420768|OG001|Outcome|BMS-986263 90 mg QW (Once Weekly)|BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793457|NCT03420768|OG002|Outcome|Placebo QW (Once Weekly)|Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793458|NCT03420768|EG000|Reported Event|BMS-986263 45 mg QW (Once Weekly)|BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793459|NCT03420768|EG001|Reported Event|BMS-986263 90 mg QW (Once Weekly)|BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793460|NCT03420768|EG002|Reported Event|Placebo QW (Once Weekly)|Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)
10793461|NCT03395288|BG000|Baseline|RCT Treatment Arm|"Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.~D-Mannose: A total of 2 g D-mannose daily"
10793462|NCT03395288|BG001|Baseline|RCT Control Arm|Participants in this arm will not use any additional intervention.
10793463|NCT03395288|BG002|Baseline|Observational Arm|"Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.~D-Mannose: A total of 2 g D-mannose daily"
10793464|NCT03395288|BG003|Baseline|Total|Total of all reporting groups
10793465|NCT03395288|FG000|Participant Flow|RCT Treatment Arm|"Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.~D-Mannose: A total of 2 g D-mannose daily"
10793466|NCT03395288|FG001|Participant Flow|RCT Control Arm|Participants in this arm will not use any additional intervention.
11241198|NCT02485301|OG000|Outcome|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
10793467|NCT03395288|FG002|Participant Flow|Observational Arm|"Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.~D-Mannose: A total of 2 g D-mannose daily"
10793468|NCT03395288|OG000|Outcome|RCT Treatment Arm|"Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.~D-Mannose: A total of 2 g D-mannose daily"
10793469|NCT03395288|OG001|Outcome|RCT Control Arm|Participants in this arm will not use any additional intervention.
10793470|NCT03395288|OG002|Outcome|Observational Arm|"Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.~D-Mannose: A total of 2 g D-mannose daily"
10793471|NCT03395288|EG000|Reported Event|RCT Treatment Arm|"Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.~D-Mannose: A total of 2 g D-mannose daily"
10793472|NCT03395288|EG001|Reported Event|RCT Control Arm|Participants in this arm will not use any additional intervention.
10793473|NCT03395288|EG002|Reported Event|Observational Arm|"Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.~D-Mannose: A total of 2 g D-mannose daily"
10793474|NCT03180307|BG000|Baseline|Experimental: OTL38 Injection and Near Infrared Imaging|"Patient injected with OTL38 and undergoes near infrared imaging.~Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes~Other Names:~OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence~Other Names:~Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery"
10793475|NCT03180307|BG001|Baseline|Sham Comparator: OTL38 Injection and No Fluorescent Imaging|"Patient injected with OTL38, but does not undergo fluorescent imaging.~Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes~Other Names:~OTL38 for Injection~Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery"
10793476|NCT03180307|BG002|Baseline|Total|Total of all reporting groups
10793477|NCT03180307|FG000|Participant Flow|Experimental: OTL38 Injection and Near Infrared Imaging|"Patient injected with OTL38 and undergoes near infrared imaging.~Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes~Other Names:~OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence~Other Names:~Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery"
10793478|NCT03180307|FG001|Participant Flow|Sham Comparator: OTL38 Injection and No Fluorescent Imaging|"Patient injected with OTL38, but does not undergo fluorescent imaging.~Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes~Other Names:~OTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery"
10793479|NCT03180307|OG000|Outcome|Full Analysis Set|"Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who:~Were evaluated under both normal light and NIR fluorescent light imaging~Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging"
11241199|NCT02485301|OG001|Outcome|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
10793480|NCT03180307|EG000|Reported Event|Safety Analysis Set|The Safety Analysis Set includes all subjects who received any amount of study drug.
10793481|NCT03151083|BG000|Baseline|Phase 1: Implementation As Usual (Implementation Through Research Team)|SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team (June 2017 - January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
10793482|NCT03151083|BG001|Baseline|Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care)|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (June 2018 to January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
10802733|NCT02173301|BG001|Baseline|XP23829 800 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period~XP 23829 800 mg QD: active dose 2"
11337796|NCT03594227|FG002|Participant Flow|ATI-501 800mg BID Dosing|"ATI-501 800mg BID dosing - oral administration~ATI-501 800mg BID dosing: ATI-501 high dose for oral administration"
10793483|NCT03151083|BG002|Baseline|Phase 3: Primary Care Mental Health Collaborative Care Implementation|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (April 2019 to November 2019). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated by the research team to provide education to patients about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow (Primary care provider placed consult in the medical record).
10793484|NCT03151083|BG003|Baseline|Total|Total of all reporting groups
10793485|NCT03151083|FG000|Participant Flow|Phase 1: Implementation As Usual (Implementation Through Research Team)|SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team (June 2017 - January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
10793486|NCT03151083|FG001|Participant Flow|Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care)|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (June 2018 to January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
10793487|NCT03151083|FG002|Participant Flow|Phase 3: Primary Care Mental Health Collaborative Care Implementation|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (April 2019 to November 2019). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated by the research team to provide education to patients about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow (Primary care provider placed consult in the medical record).
10793488|NCT03151083|OG000|Outcome|Phase 1: Implementation As Usual (Implementation Through Research Team)|SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
10793489|NCT03151083|OG001|Outcome|Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care)|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.
10793490|NCT03151083|OG002|Outcome|Phase 3: Primary Care Mental Health Collaborative Care Implementation|SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
10965772|NCT00883779|BG000|Baseline|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
10793491|NCT03151083|OG000|Outcome|All Enrollees|All enrollees are analyzed as a single group regardless of implementation period. The ISI will be the primary clinical outcome and is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia.
10793492|NCT03151083|OG000|Outcome|All Enrollees|All enrollees are analyzed as a single group regardless of implementation period.
10793493|NCT03151083|EG000|Reported Event|All Enrollees|All enrollees are analyzed as a single group regardless of implementation period.
10793494|NCT02668822|BG000|Baseline|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
10793495|NCT02668822|BG001|Baseline|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793496|NCT02668822|BG002|Baseline|Total|Total of all reporting groups
10793497|NCT02668822|FG000|Participant Flow|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of etonogestrel-17β-estradiol (ENG-E2) at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
10793498|NCT02668822|FG001|Participant Flow|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793499|NCT02668822|OG000|Outcome|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
10793500|NCT02668822|OG001|Outcome|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793501|NCT02668822|EG000|Reported Event|ENG 125 μg + E2 300 μg (MK-8342B)|Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.
10793502|NCT02668822|EG001|Reported Event|Placebo|Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793503|NCT02668783|BG000|Baseline|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
10793504|NCT02668783|BG001|Baseline|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793505|NCT02668783|BG002|Baseline|Total|Total of all reporting groups
10793506|NCT02668783|FG000|Participant Flow|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
10793507|NCT02668783|FG001|Participant Flow|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793508|NCT02668783|OG000|Outcome|ENG-E2 125 μg/300 μg|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
10793509|NCT02668783|OG001|Outcome|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793510|NCT02668783|EG000|Reported Event|ENG-E2 125 Microgram/300 Microgram|Participants received 4 (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle consisted of 21 days of vaginal ring use followed by 7 ring-free days.
10793511|NCT02668783|EG001|Reported Event|Placebo|Participants received 4 (or 6 cycles if also participating in the extension) of placebo. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
10793512|NCT02616146|BG000|Baseline|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793513|NCT02616146|BG001|Baseline|LNG-EE 150 μg/30 μg|Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
10793514|NCT02616146|BG002|Baseline|Total|Total of all reporting groups
10793515|NCT02616146|FG000|Participant Flow|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of etonogestrel + 17β-estradiol (ENG-E2) 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
11195760|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ItchRO(Pt)
10793516|NCT02616146|FG001|Participant Flow|LNG-EE 150 μg/30 μg|Participants were to receive up to 13 cycles of levonorgestrel-ethinyl estradiol (LNG-EE) 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
10793517|NCT02616146|OG000|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793518|NCT02616146|OG001|Outcome|LNG-EE 150 μg/30 μg|Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
10793519|NCT02616146|EG000|Reported Event|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
11195761|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ItchRO(Pt)
11195762|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in fasting ALP levels
11195763|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALP levels
11195764|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALT levels
11337797|NCT03594227|FG003|Participant Flow|Placebo|Placebo: BID - oral administration
11337798|NCT03594227|OG000|Outcome|ATI-501 400mg BID Dosing|"ATI-501 400mg BID dosing (low dose) - oral administration~ATI-501 Low dose: ATI-501 oral low dose"
11337799|NCT03594227|OG001|Outcome|ATI-501 600mg BID Dosing|"ATI-501 600mg BID dosing (mid dose) - oral administration~ATI-501 Mid dose"
11337800|NCT03594227|OG002|Outcome|ATI-501 800mg BID Dosing|"ATI-501 800mg BID dosing (high dose) - oral administration~ATI-501 high dose for oral administration"
11337801|NCT03594227|OG003|Outcome|Placebo|Placebo - oral administration
11337802|NCT03594227|OG000|Outcome|ATI-501 400mg BID Dosing|"ATI-501 400mg BID Dosing (low dose) - oral administration~ATI-501 Low dose: ATI-501 oral low dose"
11337803|NCT03594227|OG001|Outcome|ATI-501 600mg BID Dosing|"ATI-501 600mg BID Dosing (mid dose) - oral administration~ATI-501 Mid dose"
11337804|NCT03594227|OG002|Outcome|ATI-501 800mg BID Dosing|"ATI-501 800mg BID Dosing (high dose) - oral administration~ATI-501 high dose"
11337805|NCT03594227|OG000|Outcome|ATI-501 400mg BID|"ATI-501 400mg BID Dosing (low dose) - oral administration~ATI-501 Low dose"
11337806|NCT03594227|OG001|Outcome|ATI-501 600mg BID|"ATI-501 600mg BID (mid dose) - oral administration~ATI-501 Mid dose"
11337807|NCT03594227|OG002|Outcome|ATI-501 800mg BID|"ATI-501 800mg BID (high dose) - oral administration~ATI-501 high dose"
11337808|NCT03594227|OG000|Outcome|ATI-501 400mg BID|"ATI-501 400mg BID (low dose) - oral administration~ATI-501 Low dose"
11337809|NCT03594227|OG003|Outcome|Placebo|Vehicle - oral administration
11337810|NCT03594227|OG003|Outcome|Placebo|Placebos - oral administration
11337811|NCT03594227|OG001|Outcome|ATI-501 600mg BID|"ATI-501 600mg BID - oral administration~ATI-501 Mid dose"
11337812|NCT03594227|OG001|Outcome|ATI-501 600mg BID|"ATI-501 600mg BID (mid dose) - oral administration~ATI-501 Mid dose: ATI-501 oral low dose"
11337813|NCT03594227|EG000|Reported Event|ATI-501 400mg BID Dosing|"ATI-501 400mg BID dosing - oral administration~ATI-501 400mg BID dosing: ATI-501 oral low dose"
11337814|NCT03594227|EG001|Reported Event|ATI-501 600mg BID Dosing|"ATI-501 600mg BID dosing - oral administration~ATI-501 600mg BID dosing: ATI-501 oral low dose"
11337815|NCT03594227|EG002|Reported Event|ATI-501 800mg BID Dosing|"ATI-501 800mg BID dosing - oral administration~ATI-501 800mg BID dosing: ATI-501 high dose for oral administration"
11337816|NCT03594227|EG003|Reported Event|Placebo|Placebo: BID - oral administration
11337817|NCT03594500|BG000|Baseline|Intervention: PockeTalker|"Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department~PockeTalker: The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED"
11337818|NCT03594500|BG001|Baseline|Control: No PockeTalker|"Consenting participants will be randomly assigned to the control group while receiving care in the emergency department~No PockeTalker: The control group will not receive PockeTalkers while they receive care in the ED"
11337819|NCT03594500|BG002|Baseline|Total|Total of all reporting groups
11337820|NCT03594500|FG000|Participant Flow|Intervention: PockeTalker|"Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department~PockeTalker: The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED"
11337821|NCT03594500|FG001|Participant Flow|Control: No PockeTalker|"Consenting participants will be randomly assigned to the control group while receiving care in the emergency department~No PockeTalker: The control group will not receive PockeTalkers while they receive care in the ED"
11337822|NCT03594500|OG000|Outcome|Intervention: Received Hearing Assistance Device|(randomized to receive hearing assistance device)
11337823|NCT03594500|OG000|Outcome|Intervention|Veterans who received HAD in ED
11337824|NCT03594500|OG001|Outcome|Control|Veterans who did not receive HAD in ED
11337825|NCT03594500|OG000|Outcome|Intervention: PockeTalker|"Consenting participants will be randomly assigned to the intervention group while receiving care in the emergency department~PockeTalker: The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED"
11337826|NCT03594500|OG001|Outcome|Control: No PockeTalker|"Consenting participants will be randomly assigned to the control group while receiving care in the emergency department~No PockeTalker: The control group will not receive PockeTalkers while they receive care in the ED"
11337827|NCT03594500|EG000|Reported Event|Intervention|Veterans who received HAD in ED
11337828|NCT03594500|EG001|Reported Event|Control|Veterans who did not receive HAD in ED
11337829|NCT03595215|BG000|Baseline|TENS Treatment Arm|"This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.~TENS: Transcutaneous electrical nerve stimulation"
11337830|NCT03595215|FG000|Participant Flow|TENS Treatment Arm|"This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.~TENS: Transcutaneous electrical nerve stimulation"
11337831|NCT03595215|OG000|Outcome|TENS Treatment Arm|"This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.~TENS: Transcutaneous electrical nerve stimulation"
11337832|NCT03595215|EG000|Reported Event|TENS Treatment Arm|"This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.~TENS: Transcutaneous electrical nerve stimulation"
11337833|NCT03595280|BG000|Baseline|Control|Participants in the control group receive no study messages
11337834|NCT03595280|BG001|Baseline|Untailored Messages|"Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
11337835|NCT03595280|BG002|Baseline|Tailored Messages|"Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
11337836|NCT03595280|BG003|Baseline|Total|Total of all reporting groups
10793520|NCT02616146|EG001|Reported Event|LNG-EE 150 μg/30 μg|Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
10793521|NCT02538510|BG000|Baseline|Head and Neck Squamous Cell Carcinoma|Head and Neck Squamous Cell Carcinoma patients
10793522|NCT02538510|BG001|Baseline|Salivary Gland Carcinoma|Salivary Gland Carcinoma patients
10793523|NCT02538510|BG002|Baseline|Total|Total of all reporting groups
10793524|NCT02538510|FG000|Participant Flow|Head and Neck Squamous Cell Carcinoma|MK-3475 combined with vorinostat,HNSCC patients
10793525|NCT02538510|FG001|Participant Flow|Salivary Gland Carcinoma|MK-3475 combined with votinostat, SGC patients
10793526|NCT02538510|OG000|Outcome|Head and Neck Squamous Cell Carcinoma|AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
10793527|NCT02538510|OG001|Outcome|Salivary Gland Carcinoma|AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
10793528|NCT02538510|OG000|Outcome|Head and Neck Squamous Cell|Head and Neck Squamous Cell RECIST 1.1
10793529|NCT02538510|OG001|Outcome|Salivary Gland Carcinoma|RECIST 1.1 response rate salivary gland
10793530|NCT02538510|OG000|Outcome|Head and Neck Squamous Cell Carcinoma|Head and Neck Squamous Cell Carcinoma patients
10793531|NCT02538510|OG001|Outcome|Salivary Gland Carcinoma|Salivary Gland Carcinoma patients
10793532|NCT02538510|EG000|Reported Event|Head and Neck Squamous Cell Carcinoma|MK-3475 combined with vorinostat in HNSCC patients
10793533|NCT02538510|EG001|Reported Event|Salivary Gland Carcinoma|MK-3475 combined with vorinostat in SGC patients
10793534|NCT02524288|BG000|Baseline|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
11241200|NCT02485301|EG000|Reported Event|GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm.
10793535|NCT02524288|FG000|Participant Flow|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793536|NCT02524288|OG000|Outcome|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793537|NCT02524288|EG000|Reported Event|ENG-E2 125 μg/300 μg|Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10802734|NCT02173301|BG002|Baseline|XP23829 400 mg BID (Twice Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period~XP23829 400 mg BID: active dose 3"
10802735|NCT02173301|BG003|Baseline|Placebo|"After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks~Placebo: control"
10802736|NCT02173301|BG004|Baseline|Total|Total of all reporting groups
10802737|NCT02173301|FG000|Participant Flow|XP23829 400 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period~XP23829 400 mg QD: active dose 1"
10802738|NCT02173301|FG001|Participant Flow|XP23829 800 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period~XP 23829 800 mg QD: active dose 2"
10802739|NCT02173301|FG002|Participant Flow|XP23829 400 mg BID (Twice Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period~XP23829 400 mg BID: active dose 3"
10802740|NCT02173301|FG003|Participant Flow|Placebo|"After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks~Placebo: control"
10802741|NCT02173301|OG000|Outcome|XP23829 400 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period~XP23829 400 mg QD: active dose 1"
10802742|NCT02173301|OG001|Outcome|XP23829 800 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period~XP 23829 800 mg QD: active dose 2"
10802743|NCT02173301|OG002|Outcome|XP23829 400 mg BID (Twice Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period~XP23829 400 mg BID: active dose 3"
10802744|NCT02173301|OG003|Outcome|Placebo|"After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks~Placebo: control"
10802745|NCT02173301|EG000|Reported Event|XP23829 400 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period~XP23829 400 mg QD: active dose 1"
10802746|NCT02173301|EG001|Reported Event|XP23829 800 mg QD (Once Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period~XP 23829 800 mg QD: active dose 2"
10802747|NCT02173301|EG002|Reported Event|XP23829 400 mg BID (Twice Daily)|"After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period~XP23829 400 mg BID: active dose 3"
10802748|NCT02173301|EG003|Reported Event|Placebo|"After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks~Placebo: control"
10802749|NCT01986114|BG000|Baseline|SM-13496 20-120mg|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg"
10802750|NCT01986114|FG000|Participant Flow|SM-13496 20-120mg|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg"
10802751|NCT01986114|OG000|Outcome|SM-13496 20-120mg (Overall, 28 Weeks)|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks"
10802752|NCT01986114|OG001|Outcome|SM-13496 20-120mg (Japan, 52 Weeks)|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks"
10802753|NCT01986114|EG000|Reported Event|SM-13496 20-120mg (Overall, 28 Weeks)|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks"
10793538|NCT02489942|BG000|Baseline|JARDIANCE® User 10 Milligram (mg) or 25 mg|Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks.
10793539|NCT02489942|FG000|Participant Flow|JARDIANCE® User 10 Milligram (mg) or 25 mg|Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks.
10793540|NCT02489942|OG000|Outcome|JARDIANCE® User 10 Milligram (mg) or 25 mg|Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks.
10793541|NCT02489942|EG000|Reported Event|JARDIANCE® User 10 Milligram (mg) or 25 mg|Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks.
10793542|NCT02409342|BG000|Baseline|Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)|"Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).~Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months)."
10793543|NCT02409342|BG001|Baseline|Atezolizumab|Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
10793544|NCT02409342|BG002|Baseline|Total|Total of all reporting groups
10793545|NCT02409342|FG000|Participant Flow|Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)|"Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).~Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months)."
10793546|NCT02409342|FG001|Participant Flow|Atezolizumab|Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
10793547|NCT02409342|OG000|Outcome|Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)|"Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).~Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months)."
10793548|NCT02409342|OG001|Outcome|Atezolizumab|Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
10793549|NCT02409342|OG000|Outcome|Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)|Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
10802754|NCT01986114|EG001|Reported Event|SM-13496 20-120mg (Japan, 52 Weeks)|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks"
10802755|NCT01986101|BG000|Baseline|Placebo|"once daily orally~Placebo"
10793550|NCT02409342|OG000|Outcome|Atezolizumab|Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
10793551|NCT02409342|EG000|Reported Event|Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)|"Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).~Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months)."
10793552|NCT02409342|EG001|Reported Event|Atezolizumab|Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
10793553|NCT02293655|BG000|Baseline|MPH Discontinuation|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793554|NCT02293655|BG001|Baseline|Sustained MPH|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793555|NCT02293655|BG002|Baseline|Total|Total of all reporting groups
10793556|NCT02293655|FG000|Participant Flow|MPH Discontinuation|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793557|NCT02293655|FG001|Participant Flow|Sustained MPH|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793558|NCT02293655|OG000|Outcome|MPH Discontinuation|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793559|NCT02293655|OG001|Outcome|Sustained MPH|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
11202228|NCT02206217|OG001|Outcome|MS Group|Multi-segment lens (or called DIMS lens)
10793560|NCT02293655|EG000|Reported Event|MPH Discontinuation|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793561|NCT02293655|EG001|Reported Event|Sustained MPH|"Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children <25kg: 18mg, 27mg, 36mg; children >25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion.~DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks.~DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).~OROS-Methylphenidate (MPH): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA."
10793562|NCT02275546|BG000|Baseline|All Randomized Participants|
10793563|NCT02275546|FG000|Participant Flow|Applicator→No Applicator (Manual)|In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.
10793564|NCT02275546|FG001|Participant Flow|No Applicator (Manual)→Applicator|In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
10793565|NCT02275546|OG000|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
10793566|NCT02275546|OG001|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
10793567|NCT02275546|EG000|Reported Event|Applicator|Participants used the applicator to insert the vaginal ring.
10793568|NCT02275546|EG001|Reported Event|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
10793569|NCT02077166|BG000|Baseline|Phase 1: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793570|NCT02077166|BG001|Baseline|Phase 1: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
10793571|NCT02077166|BG002|Baseline|Phase 1: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793572|NCT02077166|BG003|Baseline|Phase 1: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793573|NCT02077166|BG004|Baseline|Phase 1: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793574|NCT02077166|BG005|Baseline|Phase 2: Enrolled at Lenalidomide Dose 20 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793575|NCT02077166|BG006|Baseline|Phase 2: Enrolled at Lenalidomide Dose 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793576|NCT02077166|BG007|Baseline|Total|Total of all reporting groups
10793577|NCT02077166|FG000|Participant Flow|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)|Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
10793578|NCT02077166|FG001|Participant Flow|Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)|De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
11241201|NCT02485301|EG001|Reported Event|Placebo+GSK3390107A Group|Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm.
11337837|NCT03595280|FG000|Participant Flow|Control|Participants in the control group receive no study messages
10793579|NCT02077166|FG002|Participant Flow|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)|Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793580|NCT02077166|FG003|Participant Flow|Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793581|NCT02077166|FG004|Participant Flow|Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793582|NCT02077166|FG005|Participant Flow|Phase 2: Enrolled at Lenalidomide Dose 20 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793583|NCT02077166|FG006|Participant Flow|Phase 2: Enrolled at Lenalidomide Dose 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793584|NCT02077166|OG000|Outcome|All Phase 1b Participants|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793585|NCT02077166|OG000|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793586|NCT02077166|OG001|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
10793587|NCT02077166|OG002|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793588|NCT02077166|OG003|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793589|NCT02077166|OG004|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793590|NCT02077166|OG000|Outcome|Phase 2: Enrolled at Lenalidomide Dose 20 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793591|NCT02077166|OG001|Outcome|Phase 2: Enrolled at Lenalidomide Dose 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
11241202|NCT02485353|BG000|Baseline|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
10793592|NCT02077166|OG002|Outcome|Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793593|NCT02077166|OG001|Outcome|Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793594|NCT02077166|OG005|Outcome|Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10, 15, 20, or 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10802756|NCT01986101|BG001|Baseline|SM-13496 20 - 60 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6"
10793595|NCT02077166|OG002|Outcome|Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 to 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793596|NCT02077166|EG000|Reported Event|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793597|NCT02077166|EG001|Reported Event|Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793598|NCT02077166|EG002|Reported Event|Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793599|NCT02077166|EG003|Reported Event|Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793600|NCT02077166|EG004|Reported Event|Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles
10793601|NCT02077166|EG005|Reported Event|Phase 2: Enrolled at Lenalidomide Dose 20 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793602|NCT02077166|EG006|Reported Event|Phase 2: Enrolled at Lenalidomide Dose 25 mg|Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
10793603|NCT01891344|BG000|Baseline|tBRCA|Patients with a deleterious BRCA mutation detected in their tumor.
10793604|NCT01891344|BG001|Baseline|Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH.
10793605|NCT01891344|BG002|Baseline|Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH.
10793606|NCT01891344|BG003|Baseline|Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
10793607|NCT01891344|BG004|Baseline|Total|Total of all reporting groups
10793608|NCT01891344|FG000|Participant Flow|Part 1: tBRCA|Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. Part 1 enrolled patients who received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
10793609|NCT01891344|FG001|Participant Flow|Part 1: Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH (loss of heterozygosity). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
10793610|NCT01891344|FG002|Participant Flow|Part 1: Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH. Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
10793611|NCT01891344|FG003|Participant Flow|Part 1: Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
10793612|NCT01891344|FG004|Participant Flow|Part 2: tBRCA|Patients with a deleterious BRCA mutation detected in their tumor. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
10793613|NCT01891344|FG005|Participant Flow|Part 2: Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
10793614|NCT01891344|FG006|Participant Flow|Part 2: Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
10793615|NCT01891344|FG007|Participant Flow|Part 2: Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
10793616|NCT01891344|OG000|Outcome|Part 1: tBRCA|Patients with a deleterious BRCA mutation detected in their tumor.
10793617|NCT01891344|OG001|Outcome|Part 1: Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH.
10793618|NCT01891344|OG002|Outcome|Part 1: Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH.
10793619|NCT01891344|OG003|Outcome|Part 1: Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
10793620|NCT01891344|OG000|Outcome|Part 2: tBRCA|Patients with a deleterious BRCA mutation detected in their tumor.
10793621|NCT01891344|OG001|Outcome|Part 2: Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH.
10793622|NCT01891344|OG002|Outcome|Part 2: Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH.
10793623|NCT01891344|OG003|Outcome|Part 2: Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
10793624|NCT01891344|OG004|Outcome|Part 2: tBRCA|Patients with a deleterious BRCA mutation detected in their tumor.
10793625|NCT01891344|OG005|Outcome|Part 2: Non-tBRCA LOH+|Patients without a BRCA mutation in their tumor, but have high LOH.
10793626|NCT01891344|OG006|Outcome|Part 2: Non-tBRCA LOH-|Patients without a BRCA mutation in their tumor, but have low LOH.
10793627|NCT01891344|OG007|Outcome|Part 2: Non-tBRCA LOH Unknown|Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
10793628|NCT01891344|OG000|Outcome|Part 1 Overall|Includes all Part 1 patients
10793629|NCT01891344|OG001|Outcome|Part 2 Overall|Includes all Part 2 patients
10793630|NCT01891344|EG000|Reported Event|Part 1 Overall|All patients who participated in Part 1 who received at least one dose of rucaparib
10793631|NCT01891344|EG001|Reported Event|Part 2 Overall|All patients who participated in Part 2 who received at least one dose of rucaparib
10793632|NCT01847274|BG000|Baseline|gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793633|NCT01847274|BG001|Baseline|gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793634|NCT01847274|BG002|Baseline|Non-gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793635|NCT01847274|BG003|Baseline|Non- gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793636|NCT01847274|BG004|Baseline|Total|Total of all reporting groups
10793637|NCT01847274|FG000|Participant Flow|gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793638|NCT01847274|FG001|Participant Flow|gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793639|NCT01847274|FG002|Participant Flow|Non-gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793640|NCT01847274|FG003|Participant Flow|Non-gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793641|NCT01847274|OG000|Outcome|gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793642|NCT01847274|OG001|Outcome|gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients with germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793643|NCT01847274|OG000|Outcome|Non-gBRCAmut HRD+ Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
10793644|NCT01847274|OG001|Outcome|Non-gBRCAmut HRD+ Placebo|Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
10793645|NCT01847274|OG000|Outcome|Non-gBRCA Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793646|NCT01847274|OG001|Outcome|Non-gBRCA Placebo|Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
10793647|NCT01847274|EG000|Reported Event|Niraparib|Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients. Niraparib vs. Placebo 2:1 ratio
10793648|NCT01847274|EG001|Reported Event|Placebo|Placebo once daily in 28-day cycles until disease progression in patients. Niraparib vs. Placebo 2:1 ratio
10793649|NCT01670656|BG000|Baseline|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793650|NCT01670656|BG001|Baseline|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793651|NCT01670656|BG002|Baseline|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793652|NCT01670656|BG003|Baseline|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793653|NCT01670656|BG004|Baseline|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793654|NCT01670656|BG005|Baseline|Total|Total of all reporting groups
10793655|NCT01670656|FG000|Participant Flow|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793656|NCT01670656|FG001|Participant Flow|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793657|NCT01670656|FG002|Participant Flow|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793658|NCT01670656|FG003|Participant Flow|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793659|NCT01670656|FG004|Participant Flow|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793660|NCT01670656|OG000|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793661|NCT01670656|OG001|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
11202229|NCT02206217|EG000|Reported Event|SV Group|single vision spectacle lens
10793662|NCT01670656|OG002|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793663|NCT01670656|OG003|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793664|NCT01670656|OG004|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793665|NCT01670656|EG000|Reported Event|NOMAC-E2 (700/300 mcg)|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days
10793666|NCT01670656|EG001|Reported Event|NOMAC-E2 (900/300 mcg)|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793667|NCT01670656|EG002|Reported Event|ENG-E2 (100/300 mcg)|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793668|NCT01670656|EG003|Reported Event|ENG-E2 (125/300 mcg)|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793669|NCT01670656|EG004|Reported Event|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10793670|NCT01501955|BG000|Baseline|Stanmore|Cemented Stanmore hip stem
10793671|NCT01501955|BG001|Baseline|MHP Hip Stem|Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
10793672|NCT01501955|BG002|Baseline|Total|Total of all reporting groups
10793673|NCT01501955|FG000|Participant Flow|Stanmore|Cemented Stanmore hip stem
10793674|NCT01501955|FG001|Participant Flow|MHP Hip Stem|Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
10793675|NCT01501955|OG000|Outcome|Stanmore|Cemented Stanmore hip stem
10793676|NCT01501955|OG001|Outcome|MHP Hip Stem|Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
10793677|NCT01501955|EG000|Reported Event|Stanmore|Cemented Stanmore hip stem
10793678|NCT01501955|EG001|Reported Event|MHP Hip Stem|Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
10793679|NCT01335399|BG000|Baseline|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793680|NCT01335399|BG001|Baseline|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793681|NCT01335399|BG002|Baseline|Total|Total of all reporting groups
10793682|NCT01335399|FG000|Participant Flow|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793683|NCT01335399|FG001|Participant Flow|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793684|NCT01335399|OG000|Outcome|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793685|NCT01335399|OG001|Outcome|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793686|NCT01335399|EG000|Reported Event|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793687|NCT01335399|EG001|Reported Event|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
10793688|NCT01277211|BG000|Baseline|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
10793689|NCT01277211|BG001|Baseline|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
10793690|NCT01277211|BG002|Baseline|Total|Total of all reporting groups
10793691|NCT01277211|FG000|Participant Flow|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
10793692|NCT01277211|FG001|Participant Flow|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
10793693|NCT01277211|OG000|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
10793694|NCT01277211|OG001|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
10793695|NCT01277211|EG000|Reported Event|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
11195765|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALT levels
11195766|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in total bilirubin
11202230|NCT02206217|EG001|Reported Event|MS Group|Multi-segment lens (or called DIMS lens)
10793696|NCT01277211|EG001|Reported Event|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
10793697|NCT01267812|BG000|Baseline|Treatment (Bortezomib and Rituximab)|"Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.~bortezomib: Given SC or IV~rituximab: Given IV~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~RNA analysis: Correlative studies~gene expression analysis: Correlative studies~DNA analysis: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~Questionnaire Administration"
10793698|NCT01267812|FG000|Participant Flow|Treatment (Bortezomib and Rituximab)|"Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.~bortezomib: Given SC or IV~rituximab: Given IV~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~RNA analysis: Correlative studies~gene expression analysis: Correlative studies~DNA analysis: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~Questionnaire Administration"
10793699|NCT01267812|OG000|Outcome|Treatment (Bortezomib and Rituximab)|"Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.~bortezomib: Given SC or IV rituximab: Given IV"
10793700|NCT01267812|EG000|Reported Event|Treatment (Bortezomib and Rituximab)|"Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.~bortezomib: Given SC or IV rituximab: Given IV"
10793701|NCT01244828|BG000|Baseline|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
10793702|NCT01244828|FG000|Participant Flow|Asenapine|All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
11195767|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in total bilirubin
11195768|NCT02160782|OG000|Outcome|Open-label Period: MRX Baseline|This secondary efficacy endpoint is the mean change from baseline to Week 18 in direct bilirubin
11195769|NCT02160782|OG001|Outcome|Open-label Period: MRX Week 18|This secondary efficacy endpoint is the mean change from baseline to Week 18 in direct bilirubin
10793703|NCT01244828|OG000|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
10793704|NCT01244828|EG000|Reported Event|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
10793705|NCT01207492|BG000|Baseline|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
10793706|NCT01207492|FG000|Participant Flow|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
10793707|NCT01207492|OG000|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
10793708|NCT01207492|EG000|Reported Event|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
11195770|NCT02160782|EG000|Reported Event|Open-label Period: Maralixibat (LUM001)|All participants received MRX at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.
11195771|NCT02160782|EG001|Reported Event|Randomized Withdrawal Period: MRX|Participants continued to receive MRX at 400 μg/kg QD during the RWD period
11195772|NCT02160782|EG002|Reported Event|Randomized Withdrawal Period: Placebo|Participants received a corresponding placebo during the RWD period
11195773|NCT02160782|EG003|Reported Event|After Randomized Withdrawal Period: Maralixibat|Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.
11195774|NCT02160782|EG004|Reported Event|Long-term Extension Period: Maralixibat|The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.
11195775|NCT02160782|EG005|Reported Event|Safety Population|The safety population was defined as all participants who were assigned and received at least one dose of the study drug.
11195776|NCT02160808|BG000|Baseline|Secretin|"Stimulate pancreatic secretion~Secretin: Drug to stimulate pancreatic secretion"
11195777|NCT02160808|BG001|Baseline|Saline|"Placebo should not stimulate the pancreas to release its fluids~Placebo"
11195778|NCT02160808|BG002|Baseline|Total|Total of all reporting groups
10793709|NCT01181778|BG000|Baseline|All Participants|All participants who were enrolled in the study
10793710|NCT01181778|FG000|Participant Flow|All Participants|All participants who were enrolled in the study
10793711|NCT01181778|OG000|Outcome|All Qualified Participants Before Counseling|Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
10793712|NCT01181778|OG001|Outcome|All Qualified Participants After Counseling|After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
10793713|NCT01181778|OG000|Outcome|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
10793714|NCT01181778|EG000|Reported Event|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
10793715|NCT01047540|BG000|Baseline|Dose Regimen 1|AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
10793716|NCT01047540|BG001|Baseline|Dose Regimen 2|AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
10793717|NCT01047540|BG002|Baseline|Dose Regimen 3|AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
10793718|NCT01047540|BG003|Baseline|Dose Regimen 4|AIC316: 400 mg QWK, Oral administration
11195779|NCT02160808|FG000|Participant Flow|Secretin|"Stimulate pancreatic secretion~Secretin: Drug to stimulate pancreatic secretion"
10793719|NCT01047540|BG004|Baseline|Placebo|Matching placebo: Oral administration
10793720|NCT01047540|BG005|Baseline|Total|Total of all reporting groups
10793721|NCT01047540|FG000|Participant Flow|Dose Regimen 1|AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
10793722|NCT01047540|FG001|Participant Flow|Dose Regimen 2|AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
10793723|NCT01047540|FG002|Participant Flow|Dose Regimen 3|AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
10793724|NCT01047540|FG003|Participant Flow|Dose Regimen 4|AIC316: 400 mg QWK, Oral administration
10793725|NCT01047540|FG004|Participant Flow|Placebo|Matching placebo: Oral administration
10793726|NCT01047540|OG000|Outcome|Dose Regimen 1|AIC316: Day 1 20 mg, Day 2-28, 5 mg QD, Oral administration
10793727|NCT01047540|OG001|Outcome|Dose Regimen 2|AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
10793728|NCT01047540|OG002|Outcome|Dose Regimen 3|AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
10793729|NCT01047540|OG003|Outcome|Dose Regimen 4|AIC316: 400 mg QWK, Oral administration
10793730|NCT01047540|OG004|Outcome|Placebo|Matching placebo: Oral administration
10793731|NCT01047540|EG000|Reported Event|Dose Regimen 1|AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
10793732|NCT01047540|EG001|Reported Event|Dose Regimen 2|AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
10793733|NCT01047540|EG002|Reported Event|Dose Regimen 3|AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
10793734|NCT01047540|EG003|Reported Event|Dose Regimen 4|AIC316: 400 mg QWK, Oral administration
10793735|NCT01047540|EG004|Reported Event|Placebo|Matching placebo: Oral administration
10793736|NCT01044056|BG000|Baseline|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
10793737|NCT01044056|BG001|Baseline|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
10793738|NCT01044056|BG002|Baseline|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
10793739|NCT01044056|BG003|Baseline|Total|Total of all reporting groups
10793740|NCT01044056|FG000|Participant Flow|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
10793741|NCT01044056|FG001|Participant Flow|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
10793742|NCT01044056|FG002|Participant Flow|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
10793743|NCT01044056|OG000|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
10793744|NCT01044056|OG001|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
11195780|NCT02160808|FG001|Participant Flow|Saline|"Placebo should not stimulate the pancreas to release its fluids~Placebo"
11195781|NCT02160808|OG000|Outcome|Secretin|"Stimulate pancreatic secretion~Secretin: Drug to stimulate pancreatic secretion"
11195782|NCT02160808|OG001|Outcome|Saline|"Placebo should not stimulate the pancreas to release its fluids~Placebo"
11195783|NCT02160808|EG000|Reported Event|Secretin|"Stimulate pancreatic secretion~Secretin: Drug to stimulate pancreatic secretion"
11195784|NCT02160808|EG001|Reported Event|Saline|"Placebo should not stimulate the pancreas to release its fluids~Placebo"
11202231|NCT02206607|BG000|Baseline|All Participants|Participants received at least 1 dose of PF-04937319.
10793745|NCT01044056|OG002|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
10793746|NCT01044056|EG000|Reported Event|Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days.
10793747|NCT01044056|EG001|Reported Event|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day.
10793748|NCT01044056|EG002|Reported Event|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
10793749|NCT00944216|BG000|Baseline|Treatment|Salkera foam twice a day
10793750|NCT00944216|FG000|Participant Flow|Treatment|Salkera foam twice a day
10793751|NCT00944216|OG000|Outcome|Treatment of Study Medication|Only one study subject was enrolled. No meaning statistical analysis could be performed.
10793752|NCT00944216|OG000|Outcome|Treatment|Only one study subject was enrolled. No meaning statistical analysis could be performed.
10793753|NCT00944216|EG000|Reported Event|Treatment|Salkera foam twice a day
10793754|NCT00886691|BG000|Baseline|Everolimus (RAD001) Plus Bevacizumab|EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
11195785|NCT02160847|BG000|Baseline|DRIVE Program|"Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.~DRIVE Program: The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity"
10793755|NCT00886691|BG001|Baseline|Placebo Plus Bevacizumab|ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793756|NCT00886691|BG002|Baseline|Total|Total of all reporting groups
10793757|NCT00886691|FG000|Participant Flow|Everolimus (RAD001) Plus Bevacizumab|EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793758|NCT00886691|FG001|Participant Flow|Placebo Plus Bevacizumab|ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793759|NCT00886691|OG000|Outcome|Everolimus (RAD001) Plus Bevacizumab|EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793760|NCT00886691|OG001|Outcome|Placebo Plus Bevacizumab|ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793761|NCT00886691|OG000|Outcome|PFS (Progression Free Survival) in Non-measurable Patients|Patients with non- measurable disease
11195786|NCT02160847|BG001|Baseline|Control Group|"The parents in the control group will be mailed information on nutrition, physical activity, and parent-child interactions. Information on nutrition will include guidelines provided by the MyPlate website (http://www.choosemyplate.gov/preschoolers.html) in addition to information on proper nutrition and suggest levels of physical activity for preschoolers. Lastly, parents will be provided with the free publication, Adventures in Parenting: How responding, Preventing, Monitoring, Mentoring, and Modeling Can Help You Be A Successful Parent, authored by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. Information covered in this document includes effective parenting strategies for children at specific ages."
10793762|NCT00886691|OG001|Outcome|PFS (Progression Free Survival) in Measurable Patients|Patients with measurable disease
10793763|NCT00886691|OG002|Outcome|OS (Overall Survival) in Non-measurable Patients|Patients with non- measurable disease
10793764|NCT00886691|OG003|Outcome|OS (Overall Survival) in Measurable Patients|Patients with measurable disease
10793765|NCT00886691|EG000|Reported Event|Everolimus (RAD001) Plus Bevacizumab|EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793766|NCT00886691|EG001|Reported Event|Placebo Plus Bevacizumab|ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
10793767|NCT00778999|BG000|Baseline|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
10793768|NCT00778999|BG001|Baseline|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
10793769|NCT00778999|BG002|Baseline|Total|Total of all reporting groups
10793770|NCT00778999|FG000|Participant Flow|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
10793771|NCT00778999|FG001|Participant Flow|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
10793772|NCT00778999|OG000|Outcome|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
10793773|NCT00778999|OG001|Outcome|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
10793774|NCT00778999|EG000|Reported Event|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
10793775|NCT00778999|EG001|Reported Event|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
10793776|NCT00620464|BG000|Baseline|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
10793777|NCT00620464|BG001|Baseline|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
10793778|NCT00620464|BG002|Baseline|Total|Total of all reporting groups
10793779|NCT00620464|FG000|Participant Flow|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
10793780|NCT00620464|FG001|Participant Flow|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
10793781|NCT00620464|OG000|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
10793782|NCT00620464|OG001|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
10793783|NCT00620464|EG000|Reported Event|Implanon|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
10793784|NCT00620464|EG001|Reported Event|Radiopaque Implanon|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
10793785|NCT00620035|BG000|Baseline|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
10793786|NCT00620035|FG000|Participant Flow|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
10793787|NCT00620035|OG000|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
10793788|NCT00620035|EG000|Reported Event|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
10793789|NCT00210249|BG000|Baseline|Eligible Patients|Patients satisfying eligibility criteria
10793790|NCT00210249|FG000|Participant Flow|Eligible Patients|Patients satisfying eligibility criteria
10793791|NCT00210249|OG000|Outcome|Eligible Patients|Patients satisfying eligibility criteria
10793792|NCT00210249|EG000|Reported Event|Eligible Patients|Patients satisfying eligibility criteria
10802757|NCT01986101|BG002|Baseline|SM-13496 80 - 120 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6"
10802758|NCT01986101|BG003|Baseline|Total|Total of all reporting groups
10802759|NCT01986101|FG000|Participant Flow|Placebo|"once daily orally~Placebo: Placebo comparator"
10802760|NCT01986101|FG001|Participant Flow|SM-13496 20 - 60 mg/Day|"once daily orally~SM-13496: SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60mg/day for Weeks 2-6"
10802761|NCT01986101|FG002|Participant Flow|SM-13496 80 - 120 mg/Day|"once daily orally~SM-13496: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6"
10802762|NCT01986101|OG000|Outcome|Placebo|"once daily orally~Placebo: Placebo comparator"
10802763|NCT01986101|OG001|Outcome|SM-13496 20 - 60 mg/Day|"once daily orally~SM-13496: SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6"
10802764|NCT01986101|OG002|Outcome|SM-13496 80 - 120 mg/Day|"once daily orally~SM-13496: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6"
10802765|NCT01986101|OG000|Outcome|Placebo|"once daily orally~Placebo"
10802766|NCT01986101|OG001|Outcome|SM-13496 20 - 60 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6"
10802767|NCT01986101|OG002|Outcome|SM-13496 80 - 120 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6"
10793793|NCT03704142|BG000|Baseline|Tweak Focus|"Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.~Tweak Focus: Participants will be tested using the Tweak Focus hearing devices."
10793794|NCT03704142|BG001|Baseline|IQ Earbuds|"Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.~IQ Earbuds: Participants will be tested using the IQ Earbuds hearing devices."
10793795|NCT03704142|BG002|Baseline|Sound World Solutions CS50+|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Sound World Solutions CS50+: Participants will be tested using the Sound World Solutions CS 50+ hearing devices."
10793796|NCT03704142|BG003|Baseline|Bose Hearphones|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Bose Hearphones: Participants will be tested using the Bose Hearphones hearing devices."
10793797|NCT03704142|BG004|Baseline|Total|Total of all reporting groups
10793798|NCT03704142|FG000|Participant Flow|Tweak Focus|"Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.~Tweak Focus: Participants will be tested using the Tweak Focus hearing devices."
10793799|NCT03704142|FG001|Participant Flow|IQ Earbuds|"Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.~IQ Earbuds: Participants will be tested using the IQ Earbuds hearing devices."
10793800|NCT03704142|FG002|Participant Flow|Sound World Solutions CS50+|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Sound World Solutions CS50+: Participants will be tested using the Sound World Solutions CS 50+ hearing devices."
10793801|NCT03704142|FG003|Participant Flow|Bose Hearphones|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Bose Hearphones: Participants will be tested using the Bose Hearphones hearing devices."
10793802|NCT03704142|OG000|Outcome|Tweak Focus|Group of participants assigned to use the Tweak Focus hearing device
10793803|NCT03704142|OG001|Outcome|CS50+|Group of participants who were assigned the Sound World Solutions CS50+ listening device
10793804|NCT03704142|OG002|Outcome|IQ Buds|Group of participants who were assigned the Nuheara IQ Buds listening device
10793805|NCT03704142|OG003|Outcome|Bose|Group of participants who were assigned the Bose Hearphones listening device
10793806|NCT03704142|EG000|Reported Event|Tweak Focus|"Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.~Tweak Focus: Participants will be tested using the Tweak Focus hearing devices."
10793807|NCT03704142|EG001|Reported Event|IQ Earbuds|"Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.~IQ Earbuds: Participants will be tested using the IQ Earbuds hearing devices."
10793808|NCT03704142|EG002|Reported Event|Sound World Solutions CS50+|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Sound World Solutions CS50+: Participants will be tested using the Sound World Solutions CS 50+ hearing devices."
10793809|NCT03704142|EG003|Reported Event|Bose Hearphones|"Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.~Bose Hearphones: Participants will be tested using the Bose Hearphones hearing devices."
10802768|NCT01986101|EG000|Reported Event|Placebo|"once daily orally~Placebo"
10802769|NCT01986101|EG001|Reported Event|SM-13496 20 - 60 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6"
10802770|NCT01986101|EG002|Reported Event|SM-13496 80 - 120 mg/Day|"once daily orally~SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6"
10802771|NCT01972035|BG000|Baseline|ValAcyclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valacyclovir: Experimental Arm"
10802772|NCT01972035|BG001|Baseline|ValGanciclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valganciclovir: Standard of care"
10802773|NCT01972035|BG002|Baseline|Total|Total of all reporting groups
10802774|NCT01972035|FG000|Participant Flow|ValAcyclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valacyclovir: Experimental Arm"
10802775|NCT01972035|FG001|Participant Flow|ValGanciclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valganciclovir: Standard of care"
10802776|NCT01972035|OG000|Outcome|ValAcyclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valacyclovir: Experimental Arm"
10802777|NCT01972035|OG001|Outcome|ValGanciclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valganciclovir: Standard of care"
10802778|NCT01972035|EG000|Reported Event|ValAcyclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valacyclovir: Experimental Arm"
10802779|NCT01972035|EG001|Reported Event|ValGanciclovir|"Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.~Valganciclovir: Standard of care"
11195787|NCT02160847|BG002|Baseline|Total|Total of all reporting groups
11383309|NCT02363998|OG000|Outcome|OL: Lofexidine HCl|Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383310|NCT02363998|OG000|Outcome|Inpatient: Pre 8AM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383311|NCT02363998|OG001|Outcome|Inpatient: 3.5 hr Post 8AM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383312|NCT02363998|OG002|Outcome|Inpatient: Pre 1PM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383313|NCT02363998|OG003|Outcome|Inpatient: 3.5 hr Post 1PM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383314|NCT02363998|OG004|Outcome|Inpatient: Pre 6PM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383315|NCT02363998|OG005|Outcome|Inpatient: 3.5 hr Post 6PM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383316|NCT02363998|OG006|Outcome|Inpatient: Pre 11PM|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383317|NCT02363998|OG007|Outcome|Outpatient: Predose|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383318|NCT02363998|OG008|Outcome|Outpatient: 3.5 hr Postdose|Lofexidine: All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
11383319|NCT02363998|OG000|Outcome|Below Baseline (End of Study)|"Shifts from normal at baseline to below baseline at the last post-baseline assessment for hematology parameters occurring in ≥3% of subjects.~Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator."
11383320|NCT02363998|OG001|Outcome|Normal (End of Study)|"Subjects whose normal baseline hematology parameters did not shift below or above baseline at the last post-baseline assessment occurring in ≥3% of subjects.~Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator."
11383321|NCT02363998|OG002|Outcome|Above Baseline (End of Study)|"Shifts from normal at baseline to above baseline at the last post-baseline assessment for hematology parameters occurring in ≥3% of subjects.~Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator."
11383322|NCT02363998|OG000|Outcome|Baseline Finding: Normal (OL: Lofexidine HCl)|
11383323|NCT02363998|OG001|Outcome|Baseline Finding: Abnormal (NCS) (OL: Lofexidine HCl)|
11383324|NCT02363998|OG002|Outcome|Baseline Finding: Abnormal (CS) (OL: Lofexidine HCl)|
11383325|NCT02363998|OG003|Outcome|Total (OL: Lofexidine HCl)|
11383326|NCT02363998|EG000|Reported Event|OL: Lofexidine HCl|"Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.~Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested."
11383327|NCT02353832|BG000|Baseline|Single Arm: Injectable Rectal Spacer|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
11383328|NCT02353832|FG000|Participant Flow|Single Arm: Injectable Rectal Spacer|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
10793810|NCT03692871|BG000|Baseline|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793811|NCT03692871|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793812|NCT03692871|BG002|Baseline|Total|Total of all reporting groups
10793813|NCT03692871|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793814|NCT03692871|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793815|NCT03692871|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793816|NCT03692871|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793817|NCT03692871|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10793818|NCT03692871|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
10802780|NCT01955980|BG000|Baseline|Buparid; Treatment A|"Buparid 1mg budesonide/2 ml nebulizer solution~Budesonide: Inhalation Solution"
10802781|NCT01955980|BG001|Baseline|Budes; Treatment B|"Budes Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal Spray"
10802782|NCT01955980|BG002|Baseline|Total|Total of all reporting groups
10802783|NCT01955980|FG000|Participant Flow|Buparid; Treatment A|"Buparid 1mg budesonide/2 ml nebulizer solution~Budesonide: Inhalation Solution"
10802784|NCT01955980|FG001|Participant Flow|Budes; Treatment B|"Budes Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal Spray"
10802785|NCT01955980|OG000|Outcome|Buparid; Treatment A|"Buparid 1mg budesonide/2 ml nebulizer solution~Budesonide: Inhalation"
10802786|NCT01955980|OG001|Outcome|Budes; Treatment B|"Budes Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal Spray"
10802787|NCT01955980|OG000|Outcome|Buparid; Treatment A|"Buparid 1mg budesonide/2 ml nebulizer solution~Budesonide: Inhalation Solution"
10802788|NCT01955980|EG000|Reported Event|Buparid; Treatment A|"Buparid 1mg budesonide/2 ml nebulizer solution~Budesonide: Inhalation Solution"
10802789|NCT01955980|EG001|Reported Event|Budes; Treatment B|"Budes Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal Spray"
10802790|NCT01946711|BG000|Baseline|Buparid; Treatment A|"Buparid 1 mg budesonide/2 ml nebuliser solution~Budesonide: Inhalation"
10802791|NCT01946711|BG001|Baseline|Budes; Treatment B|"Budes® Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal spray"
10802792|NCT01946711|BG002|Baseline|Total|Total of all reporting groups
10802793|NCT01946711|FG000|Participant Flow|Buparid; Treatment A|"Buparid 1 mg budesonide/2 ml nebuliser solution~Budesonide: Inhalation"
10802794|NCT01946711|FG001|Participant Flow|Budes; Treatment B|"Budes® Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal spray"
10802795|NCT01946711|OG000|Outcome|Buparid; Treatment A|"Buparid 1 mg budesonide/2 ml nebuliser solution~Budesonide: Inhalation"
10802796|NCT01946711|OG001|Outcome|Budes; Treatment B|"Budes® Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal spray"
10802797|NCT01946711|EG000|Reported Event|Buparid; Treatment A|"Buparid 1 mg budesonide/2 ml nebuliser solution~Budesonide: Inhalation"
10802798|NCT01946711|EG001|Reported Event|Budes; Treatment B|"Budes® Nasal Spray 50 µg budesonide/pump~Budesonide: Nasal spray"
10802799|NCT01891994|BG000|Baseline|Eltrombopag|Eltrombopag was administered for 6 months at a dose of 150mg daily in patients > 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age.
10802800|NCT01891994|FG000|Participant Flow|Eltrombopag|Eltrombopag was administered for 6 months at a dose of 150mg daily in patients > 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age. Dosing was reduced to 50% for patients of East Asian ethnicity.
11241203|NCT02485353|FG000|Participant Flow|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
10802801|NCT01891994|OG000|Outcome|Eltrombopag|Eltrombopag was administered for 6 months at a dose of 150mg daily in patients > 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age. Dosing was reduced to 50% for patients of East Asian ethnicity.
10802802|NCT01891994|EG000|Reported Event|Eltrombopag|Eltrombopag was administered for 6 months at a dose of 150mg daily in patients > 12 years of age, 75mg daily for patients 6 to 11 years of age, and 2.5 mg/kg/day for children 2-5 years of age.
10802803|NCT01839396|BG000|Baseline|Medium Continuous Dose of Stimulation|"Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802804|NCT01839396|BG001|Baseline|Low Intermittent Dose of Stimulation|"Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802805|NCT01839396|BG002|Baseline|Total|Total of all reporting groups
10793819|NCT03626168|BG000|Baseline|100% Watermelon Juice First, Then Placebo Beverage|"Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period~2-week washout period~Consumption of two 12-ounce doses of placebo beverage for a four-week period"
10793820|NCT03626168|BG001|Baseline|Placebo Beverage First, Then 100% Watermelon Juice|"Consumption of two 12-ounce doses of placebo beverage for a four-week period~2-week washout period~Consumption of two 12-ounce doses of 100% watermelon juice for a four-week period"
10793821|NCT03626168|BG002|Baseline|Total|Total of all reporting groups
10793822|NCT03626168|FG000|Participant Flow|100% Watermelon Juice First, Then Placebo Beverage|"Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period~2-week washout period~Consumption of two 12-ounce doses of placebo beverage for a four-week period"
10793823|NCT03626168|FG001|Participant Flow|Placebo Beverage First, Then 100% Watermelon Juice|"Consumption of two 12-ounce doses of placebo beverage for a four-week period~2-week washout period~Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period"
10793824|NCT03626168|OG000|Outcome|Consumption of 100% Watermelon Juice|"Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period~100% watermelon juice: Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period."
11195788|NCT02160847|FG000|Participant Flow|DRIVE Program|"Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.~DRIVE Program: The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity"
10793825|NCT03626168|OG001|Outcome|Consumption of a Placebo Beverage|"Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period~Placebo beverage: Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period."
10793826|NCT03626168|EG000|Reported Event|Consumption of 100% Watermelon Juice|Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
10793827|NCT03626168|EG001|Reported Event|Consumption of a Placebo Beverage|Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period
10793828|NCT03597035|BG000|Baseline|Patiromer Add-On|"Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.~Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day."
10793829|NCT03597035|FG000|Participant Flow|Patiromer Add-On|"Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.~Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day."
10793830|NCT03597035|OG000|Outcome|Spironolactone|Participants are to receive up to 25mg of spironolactone and 16.8g/d of patiromer.
10793831|NCT03597035|OG001|Outcome|Placebo|Participants are to receive up to 25mg of placebo and 16.8g/d of patiromer.
10793832|NCT03597035|EG000|Reported Event|Patiromer Add-On|"Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.~Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day."
10793833|NCT04823221|BG000|Baseline|Rezūm System|Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.
10793834|NCT04823221|FG000|Participant Flow|Rezūm System|Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.
10802806|NCT01839396|FG000|Participant Flow|Medium Continuous Dose of Stimulation|"Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802807|NCT01839396|FG001|Participant Flow|Low Intermittent Dose of Stimulation|"Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
11195789|NCT02160847|FG001|Participant Flow|Control Group|"The parents in the control group will be mailed information on nutrition, physical activity, and parent-child interactions. Information on nutrition will include guidelines provided by the MyPlate website (http://www.choosemyplate.gov/preschoolers.html) in addition to information on proper nutrition and suggest levels of physical activity for preschoolers. Lastly, parents will be provided with the free publication, Adventures in Parenting: How responding, Preventing, Monitoring, Mentoring, and Modeling Can Help You Be A Successful Parent, authored by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. Information covered in this document includes effective parenting strategies for children at specific ages."
10793835|NCT04823221|OG000|Outcome|Rezūm System|"The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.~Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra."
10793836|NCT04823221|EG000|Reported Event|Rezūm System|"The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.~Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra."
10802808|NCT01839396|OG000|Outcome|Medium Continuous Dose of Stimulation|"Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802809|NCT01839396|OG001|Outcome|Low Intermittent Dose of Stimulation|"Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802810|NCT01839396|EG000|Reported Event|Medium Continuous Dose of Stimulation|"Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802811|NCT01839396|EG001|Reported Event|Low Intermittent Dose of Stimulation|"Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.~Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period."
10802812|NCT01813305|BG000|Baseline|CSTC1|CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
10802813|NCT01813305|BG001|Baseline|CSTC1 Matched Vehicle|Matched vehicle, topical, two times daily
10802814|NCT01813305|BG002|Baseline|Total|Total of all reporting groups
10802815|NCT01813305|FG000|Participant Flow|CSTC1|CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
10802816|NCT01813305|FG001|Participant Flow|CSTC1 Matched Vehicle|Matched vehicle, topical, two times daily
10802817|NCT01813305|OG000|Outcome|CSTC1|CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
10802818|NCT01813305|OG001|Outcome|CSTC1 Matched Vehicle|Matched vehicle, topical, two times daily
10802819|NCT01813305|OG000|Outcome|CSTC1|"CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily~CSTC1: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof"
10802820|NCT01813305|OG001|Outcome|CSTC1 Matched Vehicle|"Matched vehicle, topical, two times daily~CSTC1 Matched vehicle"
10802821|NCT01813305|EG000|Reported Event|CSTC1|CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
10802822|NCT01813305|EG001|Reported Event|CSTC1 Matched Vehicle|Matched vehicle, topical, two times daily
10803898|NCT01146652|BG000|Baseline|Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)|Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase [ALT]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
11241204|NCT02485353|OG000|Outcome|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
11383329|NCT02353832|OG000|Outcome|Single Arm: Injectable Rectal Spacer|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
11383330|NCT02353832|EG000|Reported Event|Single Arm: Injectable Rectal Spacer|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
11383331|NCT02353728|BG000|Baseline|All Patients|"Nilotinib at a dose of 300 mg P.O. twice a day (BID) daily~Nilotinib"
11383332|NCT02353728|FG000|Participant Flow|All Patients|"Nilotinib at a dose of 300 mg P.O. twice a day (BID) daily~Nilotinib"
11383333|NCT02353728|OG000|Outcome|All Patients|"Nilotinib at a dose of 300 mg P.O. twice a day (BID) daily~Nilotinib"
11383334|NCT02353728|EG000|Reported Event|All Patients|"Nilotinib at a dose of 300 mg P.O. twice a day (BID) daily~Nilotinib"
11383335|NCT02345070|BG000|Baseline|Placebo qw|Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
11383336|NCT02345070|BG001|Baseline|SAR156597 200mg q2w|Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
11383337|NCT02345070|BG002|Baseline|SAR156597 200mg qw|Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
11383338|NCT02345070|BG003|Baseline|Total|Total of all reporting groups
11383339|NCT02345070|FG000|Participant Flow|Placebo qw|Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
11383340|NCT02345070|FG001|Participant Flow|SAR156597 200mg q2w|Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
11383341|NCT02345070|FG002|Participant Flow|SAR156597 200mg qw|Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
11383342|NCT02345070|OG000|Outcome|Placebo qw|Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
11383343|NCT02345070|OG001|Outcome|SAR156597 200mg q2w|Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
11383344|NCT02345070|OG002|Outcome|SAR156597 200mg qw|Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
11383345|NCT02345070|EG000|Reported Event|Placebo qw|Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
10802823|NCT01680965|BG000|Baseline|Phase 1 Cohort 1: Ofatumumab|Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
11383346|NCT02345070|EG001|Reported Event|SAR156597 200mg q2w|Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
11383347|NCT02345070|EG002|Reported Event|SAR156597 200mg qw|Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
11383348|NCT02325466|BG000|Baseline|All Participants|Two crossovers with all participants experiencing all 3 arms
11383349|NCT02325466|FG000|Participant Flow|Aspirin/Ticagrelor Placebo|"aspirin 81 mg daily and ticagrelor placebo twice daily~crossover order was never unblinded to PI and study team"
11383350|NCT02325466|FG001|Participant Flow|Aspirin/Ticagrelor|"aspirin 81 mg daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383351|NCT02325466|FG002|Participant Flow|Aspirin Placebo/Ticagrelor|"aspirin placebo daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383352|NCT02325466|OG000|Outcome|Aspirin/Ticagrelor Placebo|aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team
11383353|NCT02325466|OG001|Outcome|Aspirin/Ticagrelor|"aspirin 81 mg daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383354|NCT02325466|OG002|Outcome|Aspirin Placebo/Ticagrelor|"aspirin placebo daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383355|NCT02325466|OG000|Outcome|Aspirin/Ticagrelor Placebo|"aspirin 81 mg daily and ticagrelor placebo twice daily~crossover order was never unblinded to PI and study team"
11383356|NCT02325466|EG000|Reported Event|Aspirin/Ticagrelor Placebo|"aspirin 81 mg daily and ticagrelor placebo twice daily~crossover order was never unblinded to PI and study team"
11383357|NCT02325466|EG001|Reported Event|Aspirin/Ticagrelor|"aspirin 81 mg daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383358|NCT02325466|EG002|Reported Event|Aspirin Placebo/Ticagrelor|"aspirin placebo daily and ticagrelor 90 mg twice daily~crossover order was never unblinded to PI and study team"
11383359|NCT02322710|BG000|Baseline|TulleGras M.S.|"Sterile dressing that consists of viscose tissue coated with mineral vaseline~TulleGras M.S.: Vaseline gauze"
11383360|NCT02322710|BG001|Baseline|Urgotul|"Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline~Urgotul: Low-adherent dressing"
11383361|NCT02322710|BG002|Baseline|Total|Total of all reporting groups
11383362|NCT02322710|FG000|Participant Flow|TulleGras M.S.|"Sterile dressing that consists of viscose tissue coated with mineral vaseline~TulleGras M.S.: Vaseline gauze"
11383363|NCT02322710|FG001|Participant Flow|Urgotul|"Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline~Urgotul: Low-adherent dressing"
11383364|NCT02322710|OG000|Outcome|TulleGras M.S.|"Sterile dressing that consists of viscose tissue coated with mineral vaseline~TulleGras M.S.: Vaseline gauze"
11383365|NCT02322710|OG001|Outcome|Urgotul|"Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline~Urgotul: Low-adherent dressing"
11383366|NCT02322710|EG000|Reported Event|TulleGras M.S.|"Sterile dressing that consists of viscose tissue coated with mineral vaseline~TulleGras M.S.: Vaseline gauze"
11383367|NCT02322710|EG001|Reported Event|Urgotul|"Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline~Urgotul: Low-adherent dressing"
11383368|NCT02303548|BG000|Baseline|1 (Sodium Bicarbonate)|"Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min~Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes"
11383369|NCT02303548|BG001|Baseline|2 (Normal Saline)|"Normal saline 50cc intravenous injection over 2 min~Normal saline: Placebo"
10793846|NCT04579393|BG000|Baseline|Fostamatinib With Standard of Care for Treatment of COVID-19|Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793847|NCT04579393|BG001|Baseline|Placebo With Standard of Care for Treatment of COVID-19|Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793848|NCT04579393|BG002|Baseline|Total|Total of all reporting groups
10793849|NCT04579393|FG000|Participant Flow|Fostamatinib With Standard of Care for Treatment of COVID-19|Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
11195790|NCT02160847|OG000|Outcome|DRIVE Program|"Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.~DRIVE Program: The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity"
11195791|NCT02160847|OG001|Outcome|Control Group|"The parents in the control group will be mailed information on nutrition, physical activity, and parent-child interactions. Information on nutrition will include guidelines provided by the MyPlate website (http://www.choosemyplate.gov/preschoolers.html) in addition to information on proper nutrition and suggest levels of physical activity for preschoolers. Lastly, parents will be provided with the free publication, Adventures in Parenting: How responding, Preventing, Monitoring, Mentoring, and Modeling Can Help You Be A Successful Parent, authored by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. Information covered in this document includes effective parenting strategies for children at specific ages."
10793850|NCT04579393|FG001|Participant Flow|Placebo With Standard of Care for Treatment of COVID-19|Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
11195792|NCT02160847|EG000|Reported Event|DRIVE Program|"Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.~DRIVE Program: The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity"
11383370|NCT02303548|BG002|Baseline|Total|Total of all reporting groups
11383371|NCT02303548|FG000|Participant Flow|1 (Sodium Bicarbonate)|"Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min~Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes"
11383372|NCT02303548|FG001|Participant Flow|2 (Normal Saline)|"Normal saline 50cc intravenous injection over 2 min~Normal saline: Placebo"
10793851|NCT04579393|OG000|Outcome|Fostamatinib With Standard of Care for Treatment of COVID-19|Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793852|NCT04579393|OG001|Outcome|Placebo With Standard of Care for Treatment of COVID-19|Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793853|NCT04579393|OG001|Outcome|Placebo With Standard of Care for Treatment of COVID-19|Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793854|NCT04579393|EG000|Reported Event|Fostamatinib With Standard of Care for Treatment of COVID-19|Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793855|NCT04579393|EG001|Reported Event|Placebo With Standard of Care for Treatment of COVID-19|Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
10793856|NCT04426656|BG000|Baseline|Part 2 Standard of Care|Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
10802824|NCT01680965|BG001|Baseline|Phase 1 Cohort 2: Ofatumumab|Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
10802825|NCT01680965|BG002|Baseline|Phase 1 Cohort 3: Ofatumumab|Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
10802826|NCT01680965|BG003|Baseline|Phase 2: Maximum Tolerated Dose of Ofatumumab|"Phase II: Maximum tolerated dose (MTD) of Ofatumumab~Ofatumumab at 1000 mg on day 0 and 14"
10802827|NCT01680965|BG004|Baseline|Total|Total of all reporting groups
11383373|NCT02303548|OG000|Outcome|1 (Sodium Bicarbonate)|"Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min~Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes"
11383374|NCT02303548|OG001|Outcome|2 (Normal Saline)|"Normal saline 50cc intravenous injection over 2 min~Normal saline: Placebo"
11383375|NCT02303548|EG000|Reported Event|1 (Sodium Bicarbonate)|"Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min~Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes"
11383376|NCT02303548|EG001|Reported Event|2 (Normal Saline)|"Normal saline 50cc intravenous injection over 2 min~Normal saline: Placebo"
11383377|NCT02292654|BG000|Baseline|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to < 18 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0 , 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383378|NCT02292654|BG001|Baseline|Olipudase Alfa: Child Cohort|Participants aged 6 to <12 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383379|NCT02292654|BG002|Baseline|Olipudase Alfa: Infant/Early Child Cohort|Participants aged <6 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383380|NCT02292654|BG003|Baseline|Total|Total of all reporting groups
10793857|NCT04426656|BG001|Baseline|Part 2 Mini-app|"In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.~Phone application: The mini-app (used in Part 2) has four main functions:~a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;~an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);~an asynchronous message function that allows users to chat with a study staff (C.Li); and~a user profile page where users can manage all HIV test orders."
10793858|NCT04426656|BG002|Baseline|Total|Total of all reporting groups
10793859|NCT04426656|FG000|Participant Flow|Part 2 Standard of Care|Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
10793860|NCT04426656|FG001|Participant Flow|Part 2 Mini-app|"In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.~Phone application: The mini-app (used in Part 2) has four main functions:~a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;~an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);~an asynchronous message function that allows users to chat with a study staff (C.Li); and~a user profile page where users can manage all HIV test orders."
10793861|NCT04426656|OG000|Outcome|Part 2 Standard of Care|Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
10793862|NCT04426656|OG001|Outcome|Part 2 Mini-app|"In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.~Phone application: The mini-app (used in Part 2) has four main functions:~a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;~an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);~an asynchronous message function that allows users to chat with a study staff (C.Li); and~a user profile page where users can manage all HIV test orders."
10793863|NCT04426656|EG000|Reported Event|Part 2 Standard of Care|Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.
10793864|NCT04426656|EG001|Reported Event|Part 2 Mini-app|"In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.~Phone application: The mini-app (used in Part 2) has four main functions:~a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;~an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);~an asynchronous message function that allows users to chat with a study staff (C.Li); and~a user profile page where users can manage all HIV test orders."
10802828|NCT01680965|FG000|Participant Flow|Phase 1 Cohort 1:Ofatumumab|Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
10802829|NCT01680965|FG001|Participant Flow|Phase 1 Cohort 2: Ofatumumab|Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
10802830|NCT01680965|FG002|Participant Flow|Phase1 Cohort 3|Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
10802831|NCT01680965|FG003|Participant Flow|Phase 2: Maximum Tolerated Dose of Ofatumumab|"Phase II: Maximum tolerated dose (MTD) of Ofatumumab~Ofatumumab at 1000 mg on day 0 and 14"
11202232|NCT02206607|FG000|Participant Flow|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.
10802832|NCT01680965|OG000|Outcome|Phase 1: All Participants|All participants in phase 1 portion of study who received at least 1 dose of Ofatumumab either at 300 mg, 700 mg or 1000 mg.
10802833|NCT01680965|OG000|Outcome|Ofatumumab|"Phase I:~Escalating dose of ofatumumab~Phase II:~Maximum tolerated dose (MTD) of Ofatumumab~Ofatumumab: Phase I: test an escalating dose of ofatumumab at cohorts of 300 mg, 700 mg, and 1000 mg given on day 0 and 14 of study.~Phase II: Ofatumumab MTD on day 0 and 14; patients will be followed for total of 24 months (months 1, 3, 6, 12 after therapy, then at 18 and 24 months following therapy)"
10802834|NCT01680965|EG000|Reported Event|Phase 1 Cohort 1|Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
10802835|NCT01680965|EG001|Reported Event|Phase 1 Cohort 2|Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
10802836|NCT01680965|EG002|Reported Event|Phase 1 Cohort 3|Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
10802837|NCT01680965|EG003|Reported Event|Phase 2: MTD|Phase II: Maximum tolerated dose (MTD) of Ofatumumab Ofatumumab at 1000 mg on day 0 and 14
10802838|NCT01614912|BG000|Baseline|SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group|SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
10802839|NCT01614912|FG000|Participant Flow|SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group|SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
10802840|NCT01614912|OG000|Outcome|SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group|SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
10802841|NCT01614912|EG000|Reported Event|SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group|SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
10793865|NCT04325906|BG000|Baseline|High Flow Nasal Cannula Only|"Receive high flow nasal cannula only~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response."
10793866|NCT04325906|BG001|Baseline|HFNC Plus Prone Positioning|"Receive high flow nasal cannula plus prone positioning~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.~Prone positioning (PP): PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%."
10793867|NCT04325906|BG002|Baseline|Total|Total of all reporting groups
10793868|NCT04325906|FG000|Participant Flow|High Flow Nasal Cannula Only|"Receive high flow nasal cannula only~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response."
10793869|NCT04325906|FG001|Participant Flow|HFNC Plus Prone Positioning|"Receive high flow nasal cannula plus prone positioning~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.~Prone positioning (PP): PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%."
10793870|NCT04325906|OG000|Outcome|High Flow Nasal Cannula Only|"Receive high flow nasal cannula only~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response."
10793871|NCT04325906|OG001|Outcome|HFNC Plus Prone Positioning|"Receive high flow nasal cannula plus prone positioning~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.~Prone positioning (PP): PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%."
10793872|NCT04325906|EG000|Reported Event|High Flow Nasal Cannula Only|"Receive high flow nasal cannula only~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response."
10802842|NCT01614899|BG000|Baseline|SM-13496 (Lurasidone HCl) 40mg|SM-13496 40 mg was administered orally once daily.
10802843|NCT01614899|BG001|Baseline|SM-13496 (Lurasidone HCl) 80mg|SM-13496 80 mg was administered orally once daily.
10802844|NCT01614899|BG002|Baseline|Placebo|Placebo was administered orally once daily.
10802845|NCT01614899|BG003|Baseline|Total|Total of all reporting groups
10802846|NCT01614899|FG000|Participant Flow|SM-13496 (Lurasidone HCl) 40mg|SM-13496 40 mg was administered orally once daily.
10802847|NCT01614899|FG001|Participant Flow|SM-13496 (Lurasidone HCl) 80mg|SM-13496 80 mg was administered orally once daily.
11195793|NCT02160847|EG001|Reported Event|Control Group|"The parents in the control group will be mailed information on nutrition, physical activity, and parent-child interactions. Information on nutrition will include guidelines provided by the MyPlate website (http://www.choosemyplate.gov/preschoolers.html) in addition to information on proper nutrition and suggest levels of physical activity for preschoolers. Lastly, parents will be provided with the free publication, Adventures in Parenting: How responding, Preventing, Monitoring, Mentoring, and Modeling Can Help You Be A Successful Parent, authored by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. Information covered in this document includes effective parenting strategies for children at specific ages."
11195794|NCT02160873|BG000|Baseline|Chocolate Milk First, Then Placebo|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then placebo 7-8 hours prior to exercise trial.
11195795|NCT02160873|BG001|Baseline|Flavor-matched Placebo, Then Chocolate Milk|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then chocolate milk 7-8 hours prior to exercise trial.
11195796|NCT02160873|BG002|Baseline|Total|Total of all reporting groups
11195797|NCT02160873|FG000|Participant Flow|Chocolate Milk, Then Placebo|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
10793873|NCT04325906|EG001|Reported Event|HFNC Plus Prone Positioning|"Receive high flow nasal cannula plus prone positioning~high flow nasal cannula (HFNC): HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.~Prone positioning (PP): PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%."
10793874|NCT04319445|BG000|Baseline|Migraine Patients/Providers/Faculty/Staff/Other|Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
10793875|NCT04319445|FG000|Participant Flow|Migraine Patients/Providers/Faculty/Staff/Other|Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
10793876|NCT04319445|OG000|Outcome|Migraine Patients/Providers/Faculty/Staff/Other|Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
10793877|NCT04319445|EG000|Reported Event|Migraine Patients/Providers/Faculty/Staff/Other|Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
11195798|NCT02160873|FG001|Participant Flow|Flavor-matched Placebo, Then Chocolate Milk.|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
10793878|NCT04203667|BG000|Baseline|EndoRotor Resection Arm|"All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.~EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection."
10793879|NCT04203667|FG000|Participant Flow|EndoRotor Resection Arm|"All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.~EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection."
10793880|NCT04203667|OG000|Outcome|EndoRotor Resection Arm|"All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.~EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods.~The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter."
10793881|NCT04203667|OG000|Outcome|EndoRotor Resection Arm|"All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.~EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection."
10793882|NCT04203667|EG000|Reported Event|EndoRotor Resection Arm|"All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.~EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods.~The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter."
10802848|NCT01614899|FG002|Participant Flow|Placebo|Placebo was administered orally once daily.
11195799|NCT02160873|OG000|Outcome|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
10802849|NCT01614899|OG000|Outcome|SM-13496 (Lurasidone HCl) 40mg|SM-13496 40 mg was administered orally once daily.
10802850|NCT01614899|OG001|Outcome|SM-13496 (Lurasidone HCl) 80mg|SM-13496 80 mg was administered orally once daily.
10802851|NCT01614899|OG002|Outcome|Placebo|Placebo was administered orally once daily.
11195800|NCT02160873|OG001|Outcome|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
10793883|NCT03796637|BG000|Baseline|Ataluren|Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials.
10793884|NCT03796637|FG000|Participant Flow|Ataluren|Participants who had been receiving ataluren, were dosed daily 10 milligrams (mg)/kilogram (kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials.
10793885|NCT03796637|OG000|Outcome|Ataluren|Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials.
10793886|NCT03796637|EG000|Reported Event|Ataluren|Participants who had been receiving ataluren, were dosed daily 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening, for ≥9 months from ongoing PTC-sponsored nmDMD clinical trials.
10793887|NCT03679884|BG000|Baseline|Daridorexant 10 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 10 mg: Daridorexant 10 mg tablets"
10793888|NCT03679884|BG001|Baseline|Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793889|NCT03679884|BG002|Baseline|Daridorexant 50 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 50 mg: Daridorexant 50 mg tablets"
10793890|NCT03679884|BG003|Baseline|Placebo|"Film-coated tablets administered orally, once daily in the evening~Placebo: Daridorexant matching placebo tablets"
10793891|NCT03679884|BG004|Baseline|ExPlacebo/Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793892|NCT03679884|BG005|Baseline|Total|Total of all reporting groups
10793893|NCT03679884|FG000|Participant Flow|Daridorexant 10 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 10 mg: Daridorexant 10 mg tablets"
10793894|NCT03679884|FG001|Participant Flow|Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793895|NCT03679884|FG002|Participant Flow|Daridorexant 50 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 50 mg: Daridorexant 50 mg tablets"
10793896|NCT03679884|FG003|Participant Flow|Placebo|"Film-coated tablets administered orally, once daily in the evening~Placebo: Daridorexant matching placebo tablets"
10793897|NCT03679884|FG004|Participant Flow|ExPlacebo/Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793898|NCT03679884|OG000|Outcome|Daridorexant 10 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 10 mg: Daridorexant 10 mg tablets"
10793899|NCT03679884|OG001|Outcome|Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793900|NCT03679884|OG002|Outcome|Daridorexant 50 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 50 mg: Daridorexant 50 mg tablets"
10793901|NCT03679884|OG003|Outcome|Placebo|"Film-coated tablets administered orally, once daily in the evening~Placebo: Daridorexant matching placebo tablets"
10793902|NCT03679884|OG004|Outcome|ExPlacebo / Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793903|NCT03679884|EG000|Reported Event|Daridorexant 10 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 10 mg: Daridorexant 10 mg tablets"
10793904|NCT03679884|EG001|Reported Event|Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793905|NCT03679884|EG002|Reported Event|Daridorexant 50 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 50 mg: Daridorexant 50 mg tablets"
10793906|NCT03679884|EG003|Reported Event|Placebo|"Film-coated tablets administered orally, once daily in the evening~Placebo: Daridorexant matching placebo tablets"
10793907|NCT03679884|EG004|Reported Event|Ex-Placebo Daridorexant 25 mg|"Film-coated tablets administered orally, once daily in the evening~Daridorexant 25 mg: Daridorexant 25 mg tablets"
10793908|NCT03653026|BG000|Baseline|Upadacitinib 45 mg|Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.
10793909|NCT03653026|BG001|Baseline|Placebo|Participants received placebo matching to upadacitinib once daily for 8 weeks.
10793910|NCT03653026|BG002|Baseline|Total|Total of all reporting groups
11195801|NCT02160873|OG000|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk (in a cross-over design)~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
10793911|NCT03653026|FG000|Participant Flow|Part 1: Upadacitinib 45 mg|Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.
10793912|NCT03653026|FG001|Participant Flow|Part 1: Placebo|Participants received placebo matching to upadacitinib once daily for 8 weeks.
10793913|NCT03653026|FG002|Participant Flow|Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg|Participants initially assigned to upadacitinib who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
10793914|NCT03653026|FG003|Participant Flow|Part 2: Placebo / Upadacitinib 45 mg|Participants initially assigned to placebo who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
10793915|NCT03653026|OG000|Outcome|Upadacitinib 45 mg|Participants received 45 mg upadacitinib once daily for 8 weeks.
10793916|NCT03653026|OG001|Outcome|Placebo|Participants received placebo matching to upadacitinib once daily for 8 weeks.
10793917|NCT03653026|EG000|Reported Event|Part 1: Upadacitinib 45 mg|Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.
10793918|NCT03653026|EG001|Reported Event|Part 1: Placebo|Participants received placebo matching to upadacitinib once daily for 8 weeks.
10793919|NCT03653026|EG002|Reported Event|Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg|Participants initially assigned to upadacitinib who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
10802852|NCT01614899|EG000|Reported Event|SM-13496 (Lurasidone HCl) 40mg|SM-13496 40 mg was administered orally once daily.
10793920|NCT03653026|EG003|Reported Event|Part 2: Placebo / Upadacitinib 45 mg|Participants initially assigned to placebo who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
10793921|NCT03648827|BG000|Baseline|Ataluren|Participants received ataluren oral suspension 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 40 weeks.
10793922|NCT03648827|FG000|Participant Flow|Ataluren|Participants received ataluren oral suspension 10 milligrams per kilogram (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 40 weeks.
10793923|NCT03648827|OG000|Outcome|Ataluren|Participants received ataluren oral suspension 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 40 weeks.
10793924|NCT03648827|EG000|Reported Event|Ataluren|Participants received ataluren oral suspension 10 milligrams per kilogram (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 40 weeks.
10793925|NCT03553498|BG000|Baseline|IV Hydromorphone and IV Acetaminophen|"1000 mg IV acetaminophen administered over 5-10 minutes~IV acetaminophen: acetaminophen given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
10793926|NCT03553498|BG001|Baseline|IV Hydromorphone and Placebo|"100 ml IV normal saline administered over 5-10 minutes~IV placebo: given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
10793927|NCT03553498|BG002|Baseline|Total|Total of all reporting groups
10793928|NCT03553498|FG000|Participant Flow|IV Hydromorphone and IV Acetaminophen|"1000 mg IV acetaminophen administered over 5-10 minutes~IV acetaminophen: acetaminophen given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
10793929|NCT03553498|FG001|Participant Flow|IV Hydromorphone and Placebo|"100 ml IV normal saline administered over 5-10 minutes~IV placebo: given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
11195802|NCT02160873|OG001|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo (in a cross-over design)~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
10793930|NCT03553498|OG000|Outcome|IV Hydromorphone and IV Acetaminophen|"1000 mg IV acetaminophen administered over 5-10 minutes~IV acetaminophen: acetaminophen given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
11195803|NCT02160873|OG000|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
11195804|NCT02160873|OG001|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
10793931|NCT03553498|OG001|Outcome|IV Hydromorphone and Placebo|"100 ml IV normal saline administered over 5-10 minutes~IV placebo: given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
11195805|NCT02160873|OG000|Outcome|Chocolate Milk|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
11195806|NCT02160873|OG001|Outcome|Flavor-matched Placebo|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
10793932|NCT03553498|EG000|Reported Event|IV Hydromorphone and IV Acetaminophen|"1000 mg IV acetaminophen administered over 5-10 minutes~IV acetaminophen: acetaminophen given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
10793933|NCT03553498|EG001|Reported Event|IV Hydromorphone and Placebo|"100 ml IV normal saline administered over 5-10 minutes~IV placebo: given intravenously~1 mg hydromorphone: hydromorphone given intravenously"
10793934|NCT03530293|BG000|Baseline|Randomized Placebo|Participants received placebo (matching valbenazine) once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
10793935|NCT03530293|BG001|Baseline|Randomized Valbenazine|Participants received their optimized dose of valbenazine once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
10793936|NCT03530293|BG002|Baseline|Total|Total of all reporting groups
10793937|NCT03530293|FG000|Participant Flow|Pre-randomization Valbenazine|Participants received valbenazine once daily for up to 12 weeks, depending on if and when randomization occurred. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for participants <50 kg and 80 mg for participants ≥50 kg to achieve an optimal dose of valbenazine for each participant.
10793938|NCT03530293|FG001|Participant Flow|Randomized Placebo|Participants received placebo (matching valbenazine) once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
10793939|NCT03530293|FG002|Participant Flow|Randomized Valbenazine|Participants received their optimized dose of valbenazine once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.
10793940|NCT03530293|OG000|Outcome|Randomized Placebo|"Participants received placebo (matching valbenazine) once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.~Placebo oral capsule: non-active dosage form"
10793941|NCT03530293|OG001|Outcome|Randomized Valbenazine|"Participants received their optimized dose of valbenazine once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.~Valbenazine: vesicular monoamine transporter 2 (VMAT2) inhibitor"
10793942|NCT03530293|EG000|Reported Event|Pre-randomization Valbenazine|"Participants received valbenazine once daily for up to 12 weeks, depending on if and when randomization occurs. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects <50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.~Valbenazine: vesicular monoamine transporter 2 (VMAT2) inhibitor"
11195807|NCT02160873|EG000|Reported Event|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
10793943|NCT03530293|EG001|Reported Event|Randomized Placebo|"Participants received placebo (matching valbenazine) once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.~Placebo oral capsule: non-active dosage form"
10793944|NCT03530293|EG002|Reported Event|Randomized Valbenazine|"Participants received their optimized dose of valbenazine once daily from randomization (Week 8, 10, or 12) through Week 36. Randomization into this arm occurred after treatment with valbenazine once daily through randomization.~Valbenazine: vesicular monoamine transporter 2 (VMAT2) inhibitor"
10793945|NCT03505749|BG000|Baseline|TI-MBRP|Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.
10793946|NCT03505749|BG001|Baseline|Standard MBRP|The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
10793947|NCT03505749|BG002|Baseline|Total|Total of all reporting groups
10793948|NCT03505749|FG000|Participant Flow|TI-MBRP|Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.
10793949|NCT03505749|FG001|Participant Flow|Standard MBRP|The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
10793950|NCT03505749|OG000|Outcome|All Women Who Were Interested in Participation|All women who underwent informed consent and screening procedures.
10793951|NCT03505749|OG000|Outcome|TI-MBRP|Trauma Informed-Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT) into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance abuse, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events.
10793952|NCT03505749|OG001|Outcome|Standard MBRP|The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
10793953|NCT03505749|OG000|Outcome|TI-MBRP|Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.
11195808|NCT02160873|EG001|Reported Event|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
10802853|NCT01614899|EG001|Reported Event|SM-13496 (Lurasidone HCl) 80mg|SM-13496 80 mg was administered orally once daily.
10802854|NCT01614899|EG002|Reported Event|Placebo|Placebo was administered orally once daily.
10802855|NCT01592370|BG000|Baseline|Nivolumab Monotherapy (Expansion)|3mg/kg of nivolumab
10802856|NCT01592370|BG001|Baseline|Nivolumab + Ipilimumab|"3 mg/kg of nivolumab and~1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W"
10802857|NCT01592370|BG002|Baseline|Nivolumab + Lirilumab|3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
11383381|NCT02292654|FG000|Participant Flow|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to less than (<) 18 years received intravenous (IV) infusion of olipudase alfa once every 2 weeks (Q2W) for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 milligram per kilogram (mg/kg). Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383382|NCT02292654|FG001|Participant Flow|Olipudase Alfa: Child Cohort|Participants aged 6 to <12 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383383|NCT02292654|FG002|Participant Flow|Olipudase Alfa: Infant/Early Child Cohort|Participants aged <6 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383384|NCT02292654|OG000|Outcome|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to <18 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0 , 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383385|NCT02292654|OG001|Outcome|Olipudase Alfa: Child Cohort|Participants aged 6 to <12 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383386|NCT02292654|OG002|Outcome|Olipudase Alfa: Infant/Early Child Cohort|Participants aged <6 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383387|NCT02292654|OG003|Outcome|Total Participants|All participants received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. The target maintenance dose was 3.0 mg/kg, which was maintained for the remaining duration of 64 treatment weeks.
11383388|NCT02292654|OG000|Outcome|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to <18 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3,0.3, 0.6, 0.6, 1.0, 2.0 , 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383389|NCT02292654|OG000|Outcome|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to <18 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383390|NCT02292654|OG002|Outcome|Total Participants|All participants received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. The target maintenance dose was 3.0 mg/kg, which was maintained for the remaining duration of 64 treatment weeks.
11383391|NCT02292654|OG000|Outcome|Total Participants|All participants received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. The target maintenance dose was 3.0 mg/kg, which was maintained for the remaining duration of 64 treatment weeks.
10802858|NCT01592370|BG003|Baseline|Nivolumab + Daratumumab_Cohort A1|ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
10802859|NCT01592370|BG004|Baseline|Nivolumab + Daratumumab_Cohort A2|ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
11383392|NCT02292654|EG000|Reported Event|Olipudase Alfa: Adolescent Cohort|Participants aged 12 to <18 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383393|NCT02292654|EG001|Reported Event|Olipudase Alfa: Child Cohort|Participants aged 6 to <12 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383394|NCT02292654|EG002|Reported Event|Olipudase Alfa: Infant/Early Child Cohort|Participants aged <6 years received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 64 treatment weeks.
11383395|NCT02292654|EG003|Reported Event|Total Participants|All participants received IV infusion of olipudase alfa Q2W for 64 weeks. Each participant underwent a dose escalation according to the following paradigm: 0.03, 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0 mg/kg. The target maintenance dose was 3.0 mg/kg, which was maintained for the remaining duration of 64 treatment weeks.
11383396|NCT02251548|BG000|Baseline|FCR+ 420 mg Ibrutinib Daily|Patients received oral agent ibrutinib daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day ibrutinib run in, then will continue daily dosing.Fludarabine, cyclophosphamide, rituximab (FCR) will be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients will receive ibrutinib monotherapy indefinitely unless they are found to be minimal residual disease(MRD) negative in the bone marrow at the 24 months of ibrutinib maintenance timepoint, at which point they will discontinue ibrutinib to undergo active disease monitoring. If during active monitoring they develop MRD positivity in the blood, they may resume ibrutinib monotherapy. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities
10793954|NCT03505749|OG001|Outcome|Standard MBRP|"The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.~Treatment As Usual (TAU): The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use."
10793955|NCT03505749|EG000|Reported Event|TI-MBRP|Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.
10793956|NCT03505749|EG001|Reported Event|Standard MBRP|"The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.~Treatment As Usual (TAU): The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use."
10802860|NCT01592370|BG005|Baseline|Nivolumab + Daratumumab_Cohort B1|ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
10802861|NCT01592370|BG006|Baseline|Nivolumab + Daratumumab_Cohort B2|D regimen: Daratumumab alone
10802862|NCT01592370|BG007|Baseline|Total|Total of all reporting groups
10802863|NCT01592370|FG000|Participant Flow|Nivolumab Monotherapy (Expansion)|3mg/kg of nivolumab
10802864|NCT01592370|FG001|Participant Flow|Nivolumab + Ipilimumab|"3 mg/kg of nivolumab and~1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W"
10802865|NCT01592370|FG002|Participant Flow|Nivolumab + Lirilumab|3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
10802866|NCT01592370|FG003|Participant Flow|Nivolumab + Daratumumab_Cohort A1|ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
10802867|NCT01592370|FG004|Participant Flow|Nivolumab + Daratumumab_Cohort A2|ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
10802868|NCT01592370|FG005|Participant Flow|Nivolumab + Daratumumab_Cohort B1|ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
10802869|NCT01592370|FG006|Participant Flow|Nivolumab + Daratumumab_Cohort B2|D regimen: Daratumumab alone
10802870|NCT01592370|OG000|Outcome|Nivolumab Monotherapy (Expansion)|3mg/kg of nivolumab
10802871|NCT01592370|OG001|Outcome|Nivolumab + Ipilimumab|"3 mg/kg of nivolumab and~1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W"
10802872|NCT01592370|OG002|Outcome|Nivolumab + Lirilumab|3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
10802873|NCT01592370|OG000|Outcome|Nivolumab + Daratumumab_Cohort A1|"ND Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1~Pomalidomide:~4 mg po daily (Days 1-21) of each 28-day cycle~Dexamethasone:~Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old"
10802874|NCT01592370|OG001|Outcome|Nivolumab + Daratumumab_Cohort A2|"ND-Pd Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802875|NCT01592370|OG002|Outcome|Nivolumab + Daratumumab_Cohort B1|"ND Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802876|NCT01592370|OG003|Outcome|Nivolumab + Daratumumab_Cohort B2|"D Monotherapy Regimen~Each cycle is 28 days~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802877|NCT01592370|OG000|Outcome|Cohort A-1|"ND Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1~Pomalidomide:~4 mg po daily (Days 1-21) of each 28-day cycle~Dexamethasone:~Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old"
11195809|NCT02160899|BG000|Baseline|Cohort A: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10793957|NCT03472885|BG000|Baseline|Danicopan + Eculizumab|"Participants were administered 100, 150, or 200 mg danicopan TID in combination with eculizumab. Danicopan dose may have been increased within each participant, to a maximum of 200 mg TID based on safety and efficacy.~The study was based on a flexible dosing design. Data from all participants were pooled for analysis."
10793958|NCT03472885|FG000|Participant Flow|Danicopan + Eculizumab|"Participants were administered 100, 150, or 200 milligrams (mg) danicopan three times daily (TID) in combination with eculizumab. Danicopan dose may have been increased within each participant, to a maximum of 200 mg TID based on safety and efficacy.~The study was based on a flexible dosing design. Data from all participants were pooled for analysis."
10793959|NCT03472885|OG000|Outcome|Danicopan + Eculizumab|"Participants were administered 100, 150, or 200 mg danicopan TID in combination with eculizumab. Danicopan dose may have been increased within each participant, to a maximum of 200 mg TID based on safety and efficacy.~The study was based on a flexible dosing design. Data from all participants were pooled for analysis."
10793960|NCT03472885|EG000|Reported Event|Danicopan + Eculizumab|"Participants were administered 100, 150, or 200 mg danicopan TID in combination with eculizumab. Danicopan dose may have been increased within each participant, to a maximum of 200 mg TID based on safety and efficacy.~The study was based on a flexible dosing design. Data from all participants were pooled for analysis."
10793961|NCT03311269|BG000|Baseline|ClariVein RES 1% Injection|"Sodium Tetradecyl Sulfate 1% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection"
10793962|NCT03311269|BG001|Baseline|ClariVein RES 3% Injection|"Sodium Tetradecyl Sulfate 3% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection"
10793963|NCT03311269|BG002|Baseline|Total|Total of all reporting groups
10793964|NCT03311269|FG000|Participant Flow|ClariVein RES 1% Injection|"Sodium Tetradecyl Sulfate 1% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection"
10793965|NCT03311269|FG001|Participant Flow|ClariVein RES 3% Injection|"Sodium Tetradecyl Sulfate 3% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection"
10793966|NCT03311269|OG000|Outcome|ClariVein RES 1% Injection|"Sodium Tetradecyl Sulfate 1% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection"
10793967|NCT03311269|OG001|Outcome|ClariVein RES 3% Injection|"Sodium Tetradecyl Sulfate 3% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection"
10793968|NCT03311269|EG000|Reported Event|ClariVein RES 1% Injection|"Sodium Tetradecyl Sulfate 1% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection"
10793969|NCT03311269|EG001|Reported Event|ClariVein RES 3% Injection|"Sodium Tetradecyl Sulfate 3% Injection single administration~ClariVein RES: ClariVein system~Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection"
10793970|NCT03249376|BG000|Baseline|Lumateperone|"Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks~Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)"
10793971|NCT03249376|BG001|Baseline|Placebo|"Placebo administered once daily every evening for 6 weeks~Placebo: Placebo"
10793972|NCT03249376|BG002|Baseline|Total|Total of all reporting groups
10793973|NCT03249376|FG000|Participant Flow|Lumateperone|"Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks~Lumateperone: Lumateperone (ITI-007 60 mg tosylate)"
10793974|NCT03249376|FG001|Participant Flow|Placebo|"Placebo administered once daily every evening for 6 weeks~Placebo: Placebo"
10793975|NCT03249376|OG000|Outcome|Lumateperone|"Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks~Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)"
10793976|NCT03249376|OG001|Outcome|Placebo|"Placebo administered once daily every evening for 6 weeks~Placebo: Placebo"
10793977|NCT03249376|EG000|Reported Event|Lumateperone|"Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks~Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)"
10793978|NCT03249376|EG001|Reported Event|Placebo|"Placebo administered once daily every evening for 6 weeks~Placebo: Placebo"
11195810|NCT02160899|BG001|Baseline|Cohort A: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10802878|NCT01592370|OG001|Outcome|Cohort A-2|"ND-Pd Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802879|NCT01592370|OG002|Outcome|Cohort B-1|"ND Regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802880|NCT01592370|OG003|Outcome|Cohort B-2|"D Monotherapy Regimen~Each cycle is 28 days~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802881|NCT01592370|EG000|Reported Event|Nivolumab Monotherapy (Expansion)|3 mg/kg of nivolumab
10802882|NCT01592370|EG001|Reported Event|Nivolumab + Ipilimumab|"3 mg/kg of nivolumab and~1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W"
10802883|NCT01592370|EG002|Reported Event|Nivolumab + Lirilumab|3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
10802884|NCT01592370|EG003|Reported Event|Nivolumab + Daratumumab_Cohort A1|"ND regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1~Pomalidomide:~4 mg po daily (Days 1-21) of each 28-day cycle~Dexamethasone:~Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old"
10793979|NCT03118570|BG000|Baseline|Setrusumab 20 mg/kg (Blinded)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793980|NCT03118570|BG001|Baseline|Setrusumab 8 mg/kg (Blinded)|Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793981|NCT03118570|BG002|Baseline|Setrusumab 2 mg/kg (Blinded)|Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793982|NCT03118570|BG003|Baseline|Setrusumab 20 mg/kg (Open-Label)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
11195811|NCT02160899|BG002|Baseline|Cohort A: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10793983|NCT03118570|BG004|Baseline|Placebo|Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months.
10793984|NCT03118570|BG005|Baseline|Total|Total of all reporting groups
10793985|NCT03118570|FG000|Participant Flow|Setrusumab 20 mg/kg (Blinded)|Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793986|NCT03118570|FG001|Participant Flow|Setrusumab 8 mg/kg (Blinded)|Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793987|NCT03118570|FG002|Participant Flow|Setrusumab 2 mg/kg (Blinded)|Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793988|NCT03118570|FG003|Participant Flow|Setrusumab 20 mg/kg (Open-Label)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Participants were randomized to this group after amendment 4.
11195812|NCT02160899|BG003|Baseline|Cohort B: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
11195813|NCT02160899|BG004|Baseline|Cohort B: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10793989|NCT03118570|FG004|Participant Flow|Placebo|Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months. Participants originally randomized to the placebo group were reassigned to receive 20 mg/kg open-label setrusumab after amendment 4.
10793990|NCT03118570|OG000|Outcome|Setrusumab 20 mg/kg (Blinded)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
11195814|NCT02160899|BG005|Baseline|Cohort B: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195815|NCT02160899|BG006|Baseline|Total|Total of all reporting groups
11195816|NCT02160899|FG000|Participant Flow|Cohort A: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
11195817|NCT02160899|FG001|Participant Flow|Cohort A: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10793991|NCT03118570|OG001|Outcome|Setrusumab 8 mg/kg (Blinded)|Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793992|NCT03118570|OG002|Outcome|Setrusumab 2 mg/kg (Blinded)|Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793993|NCT03118570|OG000|Outcome|Setrusumab 20 mg/kg (Open-Label)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793994|NCT03118570|OG003|Outcome|Setrusumab 20 mg/kg (Open-Label)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793995|NCT03118570|OG004|Outcome|Placebo|Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months.
10793996|NCT03118570|EG000|Reported Event|Setrusumab 20 mg/kg (Blinded)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793997|NCT03118570|EG001|Reported Event|Setrusumab 8 mg/kg (Blinded)|Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793998|NCT03118570|EG002|Reported Event|Setrusumab 2 mg/kg (Blinded)|Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10793999|NCT03118570|EG003|Reported Event|Setrusumab 20 mg/kg (Open-Label)|Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10794000|NCT03118570|EG004|Reported Event|Placebo|Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
10794001|NCT03094416|BG000|Baseline|Tirosint Capsules|"During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion.~After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period).~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion."
10794002|NCT03094416|FG000|Participant Flow|Tirosint Capsules|"During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion.~After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period).~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion."
10794003|NCT03094416|OG000|Outcome|Tirosint Capsules|"During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion.~After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period).~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion."
10794004|NCT03094416|EG000|Reported Event|Treatment Period: Tirosint Capsules|"After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period).~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion."
10794005|NCT03094416|EG001|Reported Event|Run-in Period: LT4 Tablets|"During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion.~For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion."
10802885|NCT01592370|EG004|Reported Event|Nivolumab + Daratumumab_Cohort A2|"ND-PD regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802886|NCT01592370|EG005|Reported Event|Nivolumab + Daratumumab_Cohort B1|"ND regimen~Each cycle is 28 days~Nivolumab:~Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802887|NCT01592370|EG006|Reported Event|Nivolumab + Daratumumab_Cohort B2|"D Monotherapy Regimen~Each cycle is 28 days~Daratumumab:~Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1"
10802888|NCT00711269|BG000|Baseline|SM-13496 (Lurasidone HCl) 40-mg Group|SM-13496 40 mg was administered orally once daily.
10802889|NCT00711269|BG001|Baseline|SM-13496 (Lurasidone HCl) 80-mg Group|SM-13496 80 mg was administered orally once daily.
10802890|NCT00711269|BG002|Baseline|Placebo Group|Placebo was administered orally twice daily.
10802891|NCT00711269|BG003|Baseline|Risperidone Group|Risperidone 2 mg was administered orally twice daily.
10802892|NCT00711269|BG004|Baseline|Total|Total of all reporting groups
10802893|NCT00711269|FG000|Participant Flow|SM-13496 (Lurasidone HCl) 40-mg Group|SM-13496 40 mg was administered orally once daily.
10802894|NCT00711269|FG001|Participant Flow|SM-13496 (Lurasidone HCl) 80-mg Group|SM-13496 80 mg was administered orally once daily.
11195818|NCT02160899|FG002|Participant Flow|Cohort A: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195819|NCT02160899|FG003|Participant Flow|Cohort B: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10802895|NCT00711269|FG002|Participant Flow|Placebo Group|Placebo was administered orally twice daily.
11195820|NCT02160899|FG004|Participant Flow|Cohort B: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10802896|NCT00711269|FG003|Participant Flow|Risperidone Group|Risperidone was administered orally twice daily.
10802897|NCT00711269|OG000|Outcome|SM-13496 (Lurasidone HCl) 40-mg Group|SM-13496 40 mg was administered orally once daily.
10802898|NCT00711269|OG001|Outcome|SM-13496 (Lurasidone HCl) 80-mg Group|SM-13496 80 mg was administered orally once daily.
10802899|NCT00711269|OG002|Outcome|Placebo Group|Placebo was administered orally twice daily.
10802900|NCT00711269|OG003|Outcome|Risperidone Group|Risperidone was administered orally twice daily.
10802901|NCT00711269|OG003|Outcome|Risperidone Group|Placebo was administered orally twice daily.
10802902|NCT00711269|EG000|Reported Event|SM-13496 (Lurasidone HCl) 40-mg Group|SM-13496 40 mg was administered orally once daily, for 6 weeks.
10802903|NCT00711269|EG001|Reported Event|SM-13496 (Lurasidone HCl) 80-mg Group|SM-13496 40 mg was administered orally once daily on Days 1 to 7, SM-13496 60 mg on Days 8 to 14, and SM-13496 80 mg on Days 15 to 42.
10802904|NCT00711269|EG002|Reported Event|Placebo Group|Placebo was administered orally twice daily for 6 weeks.
10802905|NCT00711269|EG003|Reported Event|Risperidone Group|Risperidone 2 mg was administered orally twice daily on Days 1 to 7, risperidone 3 mg on Days 8 to 14, and risperidone 4 mg on Days 15 to 42.
10802906|NCT00152477|BG000|Baseline|Carboplatin/Paclitaxel|Carboplatin and paclitaxel alone
10802907|NCT00152477|BG001|Baseline|Carboplatin/Paclitaxel/CDP791 10mg|Carboplatin and paclitaxel plus CDP791 10mg/kg
10802908|NCT00152477|BG002|Baseline|Carboplatin/Paclitaxel/CDP791 20mg|Carboplatin and paclitaxel plus CDP791 20mg/kg
10802909|NCT00152477|BG003|Baseline|Total Title|
10802910|NCT00152477|FG000|Participant Flow|Carboplatin/Paclitaxel|Carboplatin and paclitaxel alone
10802911|NCT00152477|FG001|Participant Flow|Carboplatin/Paclitaxel/CDP791 10mg|Carboplatin and paclitaxel plus CDP791 10mg/kg
10802912|NCT00152477|FG002|Participant Flow|Carboplatin/Paclitaxel/CDP791 20mg|Carboplatin and paclitaxel plus CDP791 20mg/kg
10802913|NCT00152477|OG000|Outcome|Carboplatin/Paclitaxel (Randomized Part II SjS)|Carboplatin and paclitaxel alone (Randomized Part II Subjects Set [SjS])
10802914|NCT00152477|OG001|Outcome|Carboplatin/Paclitaxel/CDP791 (Randomized Part II SjS)|Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms
10802915|NCT00152477|OG002|Outcome|Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS)|Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set [SjS])
11195821|NCT02160899|FG005|Participant Flow|Cohort B: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195822|NCT02160899|OG000|Outcome|Cohort A: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10794006|NCT02811861|BG000|Baseline|Lenvatinib 18 mg Plus Everolimus 5 mg|Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794007|NCT02811861|BG001|Baseline|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10794008|NCT02811861|BG002|Baseline|Sunitinib 50 mg|Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794009|NCT02811861|BG003|Baseline|Total|Total of all reporting groups
10794010|NCT02811861|FG000|Participant Flow|Lenvatinib 18 mg Plus Everolimus 5 mg|Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794011|NCT02811861|FG001|Participant Flow|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10794012|NCT02811861|FG002|Participant Flow|Sunitinib 50 mg|Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794013|NCT02811861|OG000|Outcome|Lenvatinib 18 mg Plus Everolimus 5 mg|Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794014|NCT02811861|OG001|Outcome|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10794015|NCT02811861|OG002|Outcome|Sunitinib 50 mg|Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794016|NCT02811861|EG000|Reported Event|Lenvatinib 18 mg Plus Everolimus 5 mg|Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10794017|NCT02811861|EG001|Reported Event|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10794018|NCT02811861|EG002|Reported Event|Sunitinib 50 mg|Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
10802916|NCT00152477|OG003|Outcome|Carboplatin/Paclitaxel/CDP791 20mg (Randomized Part II SjS)|Carboplatin and paclitaxel plus CDP791 20mg/kg (Randomized Part II Subjects Set [SjS])
10802917|NCT00152477|OG002|Outcome|Carboplatin/Paclitaxel/CDP791 10mg (Randomized Part II SS)|Carboplatin and paclitaxel plus CDP791 10mg/kg (Randomized Part II Subjects Set [SS])
10802918|NCT00152477|EG000|Reported Event|Carboplatin/Paclitaxel (SS)|Carboplatin and paclitaxel alone.
10802919|NCT00152477|EG001|Reported Event|Carboplatin/Paclitaxel/CDP791 (SS)|Pooled CDP791 10 mg/kg or 20 mg/kg + CT treatment arms
10802920|NCT00152477|EG002|Reported Event|Carboplatin/Paclitaxel/CDP791 10mg (SS)|Carboplatin and paclitaxel plus CDP791 10mg/kg
10802921|NCT00152477|EG003|Reported Event|Carboplatin/Paclitaxel/CDP791 20mg (SS)|Carboplatin and paclitaxel plus CDP791 20mg/kg
10803899|NCT01146652|BG001|Baseline|Sarilumab Monotherapy|Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
10803900|NCT01146652|BG002|Baseline|Total Title|
10794019|NCT02734667|BG000|Baseline|CGM at Diagnosis of T1D|"Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.~CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D~Both groups followed through for up to 24 months"
10794020|NCT02734667|BG001|Baseline|Usual Care|"Participants receive usual care for T1D for 6 months post diagnosis.~Both groups followed through for up to 24 months"
10794021|NCT02734667|BG002|Baseline|Total|Total of all reporting groups
10794022|NCT02734667|FG000|Participant Flow|CGM at Diagnosis of T1D|"Participants start non-adjunctive use of continuous glucose monitoring (CGM) at diagnosis of type 1 diabetes (T1D) and continue for 6 months.~CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D~Both groups followed through for up to 24 months"
10794023|NCT02734667|FG001|Participant Flow|Usual Care|"Participants receive usual care for T1D for 6 months post diagnosis.~Both groups followed through for up to 24 months"
10794024|NCT02734667|OG000|Outcome|CGM at Diagnosis of T1D|"Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.~CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D~Both groups followed through for up to 24 months"
10794025|NCT02734667|OG001|Outcome|Usual Care|"Participants receive usual care for T1D for 6 months post diagnosis.~Both groups followed through for up to 24 months"
10794026|NCT02734667|EG000|Reported Event|CGM at Diagnosis of T1D|"Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.~CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D"
10794027|NCT02734667|EG001|Reported Event|Usual Care|Participants receive usual care for T1D for 6 months post diagnosis.
10794028|NCT02709317|BG000|Baseline|Standard Care|"In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.~Brief Intervention"
10794029|NCT02709317|BG001|Baseline|Prevention Intervention|"An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.~Prevention Intervention~Brief Intervention"
11195823|NCT02160899|OG001|Outcome|Cohort A: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195824|NCT02160899|OG002|Outcome|Cohort A: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195825|NCT02160899|OG003|Outcome|Cohort B: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10794030|NCT02709317|BG002|Baseline|Total|Total of all reporting groups
10794031|NCT02709317|FG000|Participant Flow|Standard Care|"In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.~Brief Intervention"
10794032|NCT02709317|FG001|Participant Flow|Prevention Intervention|"An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.~Prevention Intervention~Brief Intervention"
10794033|NCT02709317|OG000|Outcome|Standard Care|"In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.~Brief Intervention"
10802922|NCT04585646|BG000|Baseline|Overall Study|"Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks and then Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Orion daily disposable contact lens Gemini daily disposable contact lens"
10802923|NCT04585646|FG000|Participant Flow|Orion Then Gemini|Subjects were randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
11195826|NCT02160899|OG004|Outcome|Cohort B: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195827|NCT02160899|OG005|Outcome|Cohort B: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195828|NCT02160899|EG000|Reported Event|Cohort A: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
11195829|NCT02160899|EG001|Reported Event|Cohort A: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195830|NCT02160899|EG002|Reported Event|Cohort A: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
10794034|NCT02709317|OG001|Outcome|Prevention Intervention|"An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.~Prevention Intervention~Brief Intervention"
10794035|NCT02709317|EG000|Reported Event|Standard Care|"In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.~Brief Intervention"
10794036|NCT02709317|EG001|Reported Event|Prevention Intervention|"An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.~Prevention Intervention~Brief Intervention"
10794037|NCT02607930|BG000|Baseline|B/F/TAF|"Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food~Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first."
10794038|NCT02607930|BG001|Baseline|ABC/DTG/3TC|"Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food~Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first."
10794039|NCT02607930|BG002|Baseline|Total|Total of all reporting groups
10794040|NCT02607930|FG000|Participant Flow|B/F/TAF|Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food.
10794041|NCT02607930|FG001|Participant Flow|ABC/DTG/3TC|Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 144 weeks, without regard to food.
10794042|NCT02607930|FG002|Participant Flow|B/F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
11195831|NCT02160899|EG003|Reported Event|Cohort B: Placebo|Participants received placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10794043|NCT02607930|FG003|Participant Flow|ABC/DTG/3TC to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
10794044|NCT02607930|OG000|Outcome|B/F/TAF|Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
10794045|NCT02607930|OG001|Outcome|ABC/DTG/3TC|Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
10802924|NCT04585646|FG001|Participant Flow|Gemini Then Orion|Subjects were randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
10802925|NCT04585646|OG000|Outcome|Orion|"Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Orion daily disposable contact lens"
10802926|NCT04585646|OG001|Outcome|Gemini|"Subjects were randomized to wear Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Gemini daily disposable contact lens:"
11195832|NCT02160899|EG004|Reported Event|Cohort B: ISIS-APO(a)Rx < 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11383397|NCT02251548|FG000|Participant Flow|FCR +420mg Ibrutinib Daily|Patients received oral agent ibrutinib daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day ibrutinib run in, then will continue daily dosing.Fludarabine, cyclophosphamide, rituximab (FCR) will be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients will receive ibrutinib monotherapy indefinitely unless they are found to be minimal residual disease(MRD) negative in the bone marrow at the 24 months of ibrutinib maintenance timepoint, at which point they will discontinue ibrutinib to undergo active disease monitoring. If during active monitoring they develop MRD positivity in the blood, they may resume ibrutinib monotherapy. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities
11383398|NCT02251548|OG000|Outcome|FCR+ 420mg Ibrutinib Daily|Patients received oral agent ibrutinib daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day ibrutinib run in, then will continue daily dosing.Fludarabine, cyclophosphamide, rituximab (FCR) will be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients will receive ibrutinib monotherapy indefinitely unless they are found to be minimal residual disease(MRD) negative in the bone marrow at the 24 months of ibrutinib maintenance timepoint, at which point they will discontinue ibrutinib to undergo active disease monitoring. If during active monitoring they develop MRD positivity in the blood, they may resume ibrutinib monotherapy. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities
11383399|NCT02251548|OG000|Outcome|FCR +420mg Ibrutinib Daily|Patients received oral agent ipilimumab daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day ipilimumab run in, then will continue daily dosing.Fludarabine, cyclophosphamide, rituximab (FCR) will be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients will receive ibrutinib monotherapy indefinitely unless they are found to be minimal residual disease(MRD) negative in the bone marrow at the 24 months of ibrutinib maintenance timepoint, at which point they will discontinue ibrutinib to undergo active disease monitoring. If during active monitoring they develop MRD positivity in the blood, they may resume ibrutinib monotherapy. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities
11383400|NCT02251548|EG000|Reported Event|FCR+Ibrutinib 420mg Daily|Patients received oral agent ipilimumab daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day ipilimumab run in, then will continue daily dosing. Fludarabine, cyclophosphamide, rituximab (FCR) will be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients will receive ibrutinib monotherapy indefinitely unless they are found to be minimal residual disease(MRD) negative in the bone marrow at the 24 months of ibrutinib maintenance timepoint, at which point they will discontinue ibrutinib to undergo active disease monitoring. If during active monitoring they develop MRD positivity in the blood, they may resume ibrutinib monotherapy. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities
11383401|NCT02239354|BG000|Baseline|Cohort 1|"Up to 2 VC-01-250™ Combination Product implants~Up to 6 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383402|NCT02239354|BG001|Baseline|Cohort 2|"Up to 4 or 6 VC-01™ Combination Product implants~Up to 3 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11241205|NCT02485353|EG000|Reported Event|Vosaroxin and Cytarabine|Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L
11383403|NCT02239354|BG002|Baseline|Total|Total of all reporting groups
11383404|NCT02239354|FG000|Participant Flow|Cohort 1|"Up to 2 VC-01-250™ Combination Product implants~Up to 6 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383405|NCT02239354|FG001|Participant Flow|Cohort 2|"Up to 4 or 6 VC-01™ Combination Product implants~Up to 3 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383406|NCT02239354|OG000|Outcome|Cohort 1|"Up to 2 VC-01-250™ Combination Product implants~Up to 6 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
10802927|NCT04585646|OG000|Outcome|Overall Study|"Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks and then Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Orion daily disposable contact lens Gemini daily disposable contact lens"
11383407|NCT02239354|OG000|Outcome|Cohort 2|"Up to 4 or 6 VC-01™ Combination Product implants~Up to 3 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383408|NCT02239354|EG000|Reported Event|Cohort 1|"Up to 2 VC-01-250™ Combination Product implants~Up to 6 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383409|NCT02239354|EG001|Reported Event|Cohort 2|"Up to 4 or 6 VC-01™ Combination Product implants~Up to 3 VC-01-20 sentinel units~VC-01™ Combination Product: Biologic and Device"
11383410|NCT02234310|BG000|Baseline|Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc)|Participants received rFIXFc IV injection as follows: Prophylactic treatment regimen: started with rFIXFc 50 IU/kg weekly until a participant reached at least 50 exposure days (ED=24-hour period in which >=1 injection/dose of rFIXFc was given) to rFIXFc, withdrawal from study or end of study. Adjustments to dose and dosing interval was based on incremental recovery, subsequent Factor IX levels, physical activity, bleeding pattern, in accordance with local standards of care for prophylactic regimen (PR). Treatment with episodic (on demand) regimen can be initiated before PR at investigators discretion. Episodic (On demand; optional): rFIXFc at individual doses based on participant's clinical condition, type and severity of bleeding event until PR.
11383411|NCT02234310|FG000|Participant Flow|Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc)|Participants received rFIXFc intravenous (IV) injection as follows: Prophylactic treatment regimen: started with rFIXFc 50 International Units per kilogram (IU/kg) weekly until a participant reached at least 50 exposure days (ED=24-hour period in which greater than or equal to (>=1) injection/dose of rFIXFc was given) to rFIXFc, withdrawal from study or end of study. Adjustments to dose and dosing interval was based on incremental recovery, subsequent Factor IX levels, physical activity, bleeding pattern, in accordance with local standards of care for prophylactic regimen (PR). Treatment with episodic (on demand) regimen can be initiated before PR at investigators discretion. Episodic (On demand; optional): rFIXFc at individual doses based on participant's clinical condition, type and severity of bleeding event until PR.
11383412|NCT02234310|OG000|Outcome|Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc)|Participants received rFIXFc IV injection as follows: Prophylactic treatment regimen: started with rFIXFc 50 IU/kg weekly until a participant reached at least 50 exposure days (ED=24-hour period in which >=1 injection/dose of rFIXFc was given) to rFIXFc, withdrawal from study or end of study. Adjustments to dose and dosing interval was based on incremental recovery, subsequent Factor IX levels, physical activity, bleeding pattern, in accordance with local standards of care for prophylactic regimen (PR). Treatment with episodic (on demand) regimen can be initiated before PR at investigators discretion. Episodic (On demand; optional): rFIXFc at individual doses based on participant's clinical condition, type and severity of bleeding event until PR.
11383413|NCT02234310|EG000|Reported Event|Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc)|Participants received rFIXFc IV injection as follows: Prophylactic treatment regimen: started with rFIXFc 50 IU/kg weekly until a participant reached at least 50 exposure days (ED=24-hour period in which >=1 injection/dose of rFIXFc was given) to rFIXFc, withdrawal from study or end of study. Adjustments to dose and dosing interval was based on incremental recovery, subsequent Factor IX levels, physical activity, bleeding pattern, in accordance with local standards of care for prophylactic regimen (PR). Treatment with episodic (on demand) regimen can be initiated before PR at investigators discretion. Episodic (On demand; optional): rFIXFc at individual doses based on participant's clinical condition, type and severity of bleeding event until PR.
11383414|NCT02212015|BG000|Baseline|Pazopanib + Paclitaxel|"Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)~Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma."
11383415|NCT02212015|FG000|Participant Flow|Pazopanib + Paclitaxel|Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.
11383416|NCT02212015|OG000|Outcome|Pazopanib + Paclitaxel|"Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day~Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma."
11383417|NCT02212015|OG000|Outcome|Pazopanib + Paclitaxel|Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.
10802928|NCT04585646|EG000|Reported Event|Orion|"Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Orion daily disposable contact lens"
11383418|NCT02212015|OG000|Outcome|Pazopanib + Paclitaxel|"Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)~Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma."
11383419|NCT02212015|OG000|Outcome|Pazopanib + Paclitaxel|Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.
11383420|NCT02212015|EG000|Reported Event|Pazopanib + Paclitaxel|Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800 mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.
11383421|NCT02158091|BG000|Baseline|Phase I Cohort 1: IPI-145 25mg Once Daily + FCR|Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383422|NCT02158091|BG001|Baseline|Phase I Cohort 2: IPI-145 25mg Once Daily|Phase I Cohort 2 patients received oral agent IPI-145 25mg twice BID) daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383423|NCT02158091|BG002|Baseline|Phase II Dose Expansion ( MTD): IPI 145 25mg BID|Phase II (MTD) CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383424|NCT02158091|BG003|Baseline|Total|Total of all reporting groups
10794046|NCT02607930|OG000|Outcome|All B/F/TAF|"Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food.~Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first."
10794047|NCT02607930|OG001|Outcome|ABC/DTG/3TC to B/F/TAF|Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
10794048|NCT02607930|EG000|Reported Event|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
10794049|NCT02607930|EG001|Reported Event|ABC/DTG/3TC|ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
10794050|NCT02607930|EG002|Reported Event|B/F/TAF to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
10794051|NCT02607930|EG003|Reported Event|ABC/DTG/3TC to B/F/TAF|After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
10802929|NCT04585646|EG001|Reported Event|Gemini|"Subjects were randomized to wear Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.~Gemini daily disposable contact lens:"
10803901|NCT01146652|FG000|Participant Flow|Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)|Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase [ALT]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
10803902|NCT01146652|FG001|Participant Flow|Sarilumab Monotherapy|Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
10803903|NCT01146652|OG000|Outcome|Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)|Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase [ALT]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
11195833|NCT02160899|EG005|Reported Event|Cohort B: ISIS-APO(a)Rx >= 2000 mg|Participants received ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
11195834|NCT02160977|BG000|Baseline|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
11195835|NCT02160977|BG001|Baseline|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
11195836|NCT02160977|BG002|Baseline|Total|Total of all reporting groups
11195837|NCT02160977|FG000|Participant Flow|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
11195838|NCT02160977|FG001|Participant Flow|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
11195839|NCT02160977|OG000|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
11195840|NCT02160977|OG001|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
10794052|NCT02580058|BG000|Baseline|Avelumab|Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
10794053|NCT02580058|BG001|Baseline|Avelumab + PLD|Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
10794054|NCT02580058|BG002|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
10794055|NCT02580058|BG003|Baseline|Total|Total of all reporting groups
10794056|NCT02580058|FG000|Participant Flow|Avelumab|Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
10794057|NCT02580058|FG001|Participant Flow|Avelumab + PLD|Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
10794058|NCT02580058|FG002|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
10794059|NCT02580058|OG000|Outcome|Avelumab|Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
10794060|NCT02580058|OG001|Outcome|Avelumab + PLD|Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
10794061|NCT02580058|OG002|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
10794062|NCT02580058|EG000|Reported Event|Avelumab|Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
10794063|NCT02580058|EG001|Reported Event|Avelumab + PLD|Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
10794064|NCT02580058|EG002|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
11195841|NCT02160977|EG000|Reported Event|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
10794065|NCT02578680|BG000|Baseline|Pembrolizumab|Participants received pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10794066|NCT02578680|BG001|Baseline|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. With Amendment 10 (effective date: 23-Dec-2019), all participants will discontinue saline placebo. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10794067|NCT02578680|BG002|Baseline|Total|Total of all reporting groups
10794068|NCT02578680|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab (pembro) 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10794069|NCT02578680|FG001|Participant Flow|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. With Amendment 10 (effective date: 23-Dec-2019), all participants will discontinue saline placebo. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10794070|NCT02578680|OG000|Outcome|Pembrolizumab|Participants received pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10794071|NCT02578680|OG001|Outcome|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. With Amendment 10 (effective date: 23-Dec-2019), all participants will discontinue saline placebo. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
11195842|NCT02160977|EG001|Reported Event|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
10794072|NCT02578680|EG000|Reported Event|Pembrolizumab|Participants received pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembro 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.
10794073|NCT02578680|EG001|Reported Event|Control|Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. With Amendment 10 (effective date: 23-Dec-2019), all participants will discontinue saline placebo. If documented progression occurred, participants may have been able to receive pembrolizumab Q3W for the remainder of the study or until documented further progression.
10794103|NCT02454933|BG000|Baseline|Osimertinib 80 mg|Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 mg, orally, once daily).
10794104|NCT02454933|BG001|Baseline|Osimertinib 80 mg + Durvalumab 10mg/kg|Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
11195843|NCT02160990|BG000|Baseline|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
11195844|NCT02160990|BG001|Baseline|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
10794074|NCT02513485|BG000|Baseline|Sinemet/Placebo|"Subjects with major depression were given Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at one study visit and placebo at the other study visit. Sinemet was given first followed by placebo at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally at Visit 1 or Visit 2."
10794075|NCT02513485|BG001|Baseline|Placebo/Sinemet|"Subjects with major depression were given placebo at one study visit and Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at the other study visit. Placebo was given first followed by Sinemet at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally at Visit 1 or Visit 2."
10794076|NCT02513485|BG002|Baseline|Total|Total of all reporting groups
10794077|NCT02513485|FG000|Participant Flow|Sinemet/Placebo|"Subjects with major depression were given Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at one study visit and placebo at the other study visit. Sinemet was given first followed by placebo at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally at Visit 1 or Visit 2."
10794078|NCT02513485|FG001|Participant Flow|Placebo/Sinemet|"Subjects with major depression were given placebo at one study visit and Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at the other study visit. Placebo was given first followed by Sinemet at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally at Visit 1 or Visit 2."
10794079|NCT02513485|OG000|Outcome|Sinemet/Placebo|"Subjects with major depression were given Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at one study visit and placebo at the other study visit. Sinemet was given first followed by placebo at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally at Visit 1 or Visit 2."
10794080|NCT02513485|OG001|Outcome|Placebo/Sinemet|"Subjects with major depression will be given placebo at one study visit and Sinemet (a combination of 250 mg of levodopa and 50 mg of carbidopa) at the other study visit. Placebo will be given first followed by Sinemet at the subsequent visit.~Levodopa+carbidopa: Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet will be administered orally at Visit 1 or Visit 2.~Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally at Visit 1 or Visit 2."
11195845|NCT02160990|BG002|Baseline|Total|Total of all reporting groups
11195846|NCT02160990|FG000|Participant Flow|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
11195847|NCT02160990|FG001|Participant Flow|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
11195848|NCT02160990|OG000|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
11195849|NCT02160990|OG001|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
11195850|NCT02160990|EG000|Reported Event|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
11195851|NCT02160990|EG001|Reported Event|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
10794081|NCT02513485|EG000|Reported Event|Sinemet|Levodopa+carbidopa (Sinemet) is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet was administered orally either at Visit 1 if the subject was in the Sinemet/Placebo group or, at Visit 2 if the subject was in the Placebo/Sinemet group.
10794082|NCT02513485|EG001|Reported Event|Placebo|Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally either at Visit 1 if the subject was in the Placebo/Sinemet group or, at Visit 2 if the subject was in the Sinemet/Placebo group.
10794083|NCT02476201|BG000|Baseline|MPP ON|MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
10794084|NCT02476201|FG000|Participant Flow|MPP ON|Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead will be programmed with the MultiPoint Pacing (MPP) feature activated.
10794085|NCT02476201|OG000|Outcome|MPP ON|MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
11195852|NCT02161133|BG000|Baseline|Problem-Solving Therapy|"Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.~Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems."
11195853|NCT02161133|BG001|Baseline|Health Education|"Health education provides didactic information about Gulf War Illness~Health Education: Health Education provides didactic information about Gulf War Illness"
11195854|NCT02161133|BG002|Baseline|Total|Total of all reporting groups
11195855|NCT02161133|FG000|Participant Flow|Problem-Solving Therapy|"Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.~Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems."
11195856|NCT02161133|FG001|Participant Flow|Health Education|"Health education provides didactic information about Gulf War Illness~Health Education: Health Education provides didactic information about Gulf War Illness"
11195857|NCT02161133|OG000|Outcome|Problem-Solving Therapy|"Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.~Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems."
11195858|NCT02161133|OG001|Outcome|Health Education|"Health education provides didactic information about Gulf War Illness~Health Education: Health Education provides didactic information about Gulf War Illness"
10794086|NCT02476201|OG000|Outcome|All Enrolled Subjects|All subjects enrolled in the study are included in this outcome measure.
10794087|NCT02476201|EG000|Reported Event|Total Enrolled|All subjects enrolled in the study are included in the outcome measure.
10794105|NCT02454933|BG002|Baseline|Total|Total of all reporting groups
10794106|NCT02454933|FG000|Participant Flow|Osimertinib 80 mg|Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 milligrams [mg], orally, once daily).
10794107|NCT02454933|FG001|Participant Flow|Osimertinib 80 mg + Durvalumab 10 mg/kg|Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.
10794108|NCT02454933|OG000|Outcome|Osimertinib 80 mg + Durvalumab 10mg/kg|Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
10794109|NCT02454933|EG000|Reported Event|Osimertinib 80 mg|Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 mg, orally, once daily).
10794110|NCT02454933|EG001|Reported Event|Osimertinib 80 mg + Durvalumab 10 mg/kg|Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
10794111|NCT02426684|BG000|Baseline|IdeS® 0.24 mg/kg|patients who received 0.24mg/kg (n=17)
10794112|NCT02426684|FG000|Participant Flow|IdeS® 0.24mg/kg|Twenty patients were planned to receive 0.24mg/kg (n=20). 17 patients in total were enrolled in this study. The study closed to enrollment before completing the intended 20 participant enrollment; with 3 allocations remaining.
10794113|NCT02426684|OG000|Outcome|IdeS® 0.24 mg/kg|patients who received 0.24mg/kg (n=17)
10794114|NCT02426684|EG000|Reported Event|IdeS® 0.24 mg/kg|patients who received 0.24mg/kg (n=17)
10794115|NCT02337751|BG000|Baseline|Placebo + TVP-1012 Group|Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.
10794116|NCT02337751|BG001|Baseline|TVP-1012 + TVP-1012 Group|TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.
10794117|NCT02337751|BG002|Baseline|Total|Total of all reporting groups
10794118|NCT02337751|FG000|Participant Flow|Placebo + TVP-1012 Group|TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to Placebo group in preceding study.
10794119|NCT02337751|FG001|Participant Flow|TVP-1012 + TVP-1012 Group|TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to TVP-1012 group in preceding study.
10794120|NCT02337751|OG000|Outcome|Placebo + TVP-1012 Group|Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
10794121|NCT02337751|OG001|Outcome|TVP-1012 + TVP-1012 Group|TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
10794122|NCT02337751|OG001|Outcome|TVP-1012 +TVP-1012 Group|TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
10794123|NCT02337751|EG000|Reported Event|Placebo + TVP-1012 Group|Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
10794124|NCT02337751|EG001|Reported Event|TVP-1012 + TVP-1012 Group|TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
10794125|NCT02337725|BG000|Baseline|Placebo|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
10794126|NCT02337725|BG001|Baseline|TVP-1012 1mg|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
10794127|NCT02337725|BG002|Baseline|Total|Total of all reporting groups
10794128|NCT02337725|FG000|Participant Flow|Placebo|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
10794129|NCT02337725|FG001|Participant Flow|TVP-1012 1mg|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
10794130|NCT02337725|OG000|Outcome|Placebo|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
10794131|NCT02337725|OG001|Outcome|TVP-1012 1mg|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
10794132|NCT02337725|EG000|Reported Event|Placebo|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
10794133|NCT02337725|EG001|Reported Event|TVP-1012 1mg|For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
10794134|NCT02332655|BG000|Baseline|Cannabidiol|"All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 48 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of epilepsy in patients with Sturge-Weber syndrome.~Cannabidiol: Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.~The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed."
10794135|NCT02332655|FG000|Participant Flow|Cannabidiol|"All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 48 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of epilepsy in patients with Sturge-Weber syndrome.~Cannabidiol: Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.~The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed."
10794136|NCT02332655|OG000|Outcome|Cannabidiol|"All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 48 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of epilepsy in patients with Sturge-Weber syndrome.~Cannabidiol: Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.~The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed."
10794137|NCT02332655|EG000|Reported Event|Cannabidiol|"All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 48 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of epilepsy in patients with Sturge-Weber syndrome.~Cannabidiol: Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.~The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed."
10802930|NCT04451330|BG000|Baseline|Trifarotene + Doxycycline|Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802931|NCT04451330|BG001|Baseline|Trifarotene Vehicle + Doxycycline Placebo|Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802932|NCT04451330|BG002|Baseline|Total|Total of all reporting groups
10802933|NCT04451330|FG000|Participant Flow|Trifarotene (CD5789) Cream + Doxycycline|Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802934|NCT04451330|FG001|Participant Flow|Trifarotene Vehicle + Doxycycline Placebo|Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
11195859|NCT02161133|EG000|Reported Event|Problem-Solving Therapy|"Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.~Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems."
10802935|NCT04451330|OG000|Outcome|Trifarotene + Doxycycline|Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802936|NCT04451330|OG001|Outcome|Trifarotene Vehicle + Doxycycline Placebo|Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802937|NCT04451330|EG000|Reported Event|Trifarotene + Doxycycline|Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
10802938|NCT04451330|EG001|Reported Event|Trifarotene Vehicle + Doxycycline Placebo|Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
11195860|NCT02161133|EG001|Reported Event|Health Education|"Health education provides didactic information about Gulf War Illness~Health Education: Health Education provides didactic information about Gulf War Illness"
11195861|NCT02161146|BG000|Baseline|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
10794138|NCT02130687|BG000|Baseline|Amlodipine|"Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10794139|NCT02130687|BG001|Baseline|Ramipril|"Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10794140|NCT02130687|BG002|Baseline|Valsartan|"Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10794141|NCT02130687|BG003|Baseline|Total|Total of all reporting groups
10794142|NCT02130687|FG000|Participant Flow|Amlodipine|"Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10802939|NCT04300010|BG000|Baseline|Blue Light Therapy|Blue Light Therapy: Blue light therapy treatment for acne
10802940|NCT04300010|BG001|Baseline|5% Topical Benzoyl Peroxide Gel|5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
10802941|NCT04300010|BG002|Baseline|Light and Gel|"5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne~Blue Light Therapy: Blue light therapy treatment for acne"
11195862|NCT02161146|BG001|Baseline|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
10802942|NCT04300010|BG003|Baseline|Total|Total of all reporting groups
10803904|NCT01146652|OG001|Outcome|Sarilumab Monotherapy|Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
11195863|NCT02161146|BG002|Baseline|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
11195864|NCT02161146|BG003|Baseline|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
11195865|NCT02161146|BG004|Baseline|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
11195866|NCT02161146|BG005|Baseline|Total|Total of all reporting groups
11195867|NCT02161146|FG000|Participant Flow|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
11195868|NCT02161146|FG001|Participant Flow|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
10794143|NCT02130687|FG001|Participant Flow|Ramipril|"Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10794144|NCT02130687|FG002|Participant Flow|Valsartan|"Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.~Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.~Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.~Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal."
10794145|NCT02130687|OG000|Outcome|Amlodipine Plus Placebo/Placebo|Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
10794146|NCT02130687|OG001|Outcome|Amlodipine Plus Sitagliptin/Placebo|Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
10794147|NCT02130687|OG002|Outcome|Amlodipine Plus Sitagliptin/Aprepitant|Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
10794148|NCT02130687|OG003|Outcome|Ramipril Plus Placebo/Placebo|Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
10794149|NCT02130687|OG004|Outcome|Ramipril Plus Sitagliptin/Placebo|Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
10794150|NCT02130687|OG005|Outcome|Ramipril Plus Sitagliptin/Aprepitant|Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
10794151|NCT02130687|OG006|Outcome|Valsartan Plus Placebo/Placebo|Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
10794152|NCT02130687|OG007|Outcome|Valsartan Plus Sitagliptin/Placebo|Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
10794153|NCT02130687|OG008|Outcome|Valsartan Plus Sitagliptin/Aprepitant|Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
10794154|NCT02130687|EG000|Reported Event|Washout Prior to Amlodipine|Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. Subjects underwent washout prior to starting amlodipine.
10794155|NCT02130687|EG001|Reported Event|Amlodipine Alone|"Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~During the first four weeks and between crossover therapies, participants received amlodipine alone."
10794156|NCT02130687|EG002|Reported Event|Amlodipine Plus Sitagliptin/Placebo|Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
10794157|NCT02130687|EG003|Reported Event|Amlodipine Plus Placebo/Placebo|Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
10794158|NCT02130687|EG004|Reported Event|Amlodipine Plus Sitagliptin/Aprepitant|Participants received amlodipine 10mg/day for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
10794159|NCT02130687|EG005|Reported Event|Washout Prior to Ramipril|Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting ramipril.
10794160|NCT02130687|EG006|Reported Event|Ramipril Alone|"Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks.~After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~During the first four weeks and between crossover therapies, participants received ramipril alone."
10794161|NCT02130687|EG007|Reported Event|Ramipril Plus Placebo/Placebo|Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
10794162|NCT02130687|EG008|Reported Event|Ramipril Plus Sitagliptin/Placebo|Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
10794163|NCT02130687|EG009|Reported Event|Ramipril Plus Sitagliptin/Aprepitant|Participants in this group received ramipril 10mg/d for 15 days. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
10794164|NCT02130687|EG010|Reported Event|Washout Prior to Valsartan|Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting valsartan.
10794165|NCT02130687|EG011|Reported Event|Valsartan Alone|"Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.~During the first four weeks and between crossover therapies, participants received valsartan alone."
10794166|NCT02130687|EG012|Reported Event|Valsartan Plus Placebo/Placebo|Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
10794167|NCT02130687|EG013|Reported Event|Valsartan Plus Sitagliptin/Placebo|Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
10794168|NCT02130687|EG014|Reported Event|Valsartan Plus Sitagliptin/Aprepitant|Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
10802943|NCT04300010|FG000|Participant Flow|Blue Light Therapy|The blue light therapy device will be centered over the deltopectoral interval according to device standardized use instructions and a 23-minute treatment will be administered to dry skin. Following treatment, a skin swab culture of the treatment shoulder will be taken, then both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder.
10802944|NCT04300010|FG001|Participant Flow|5% Topical Benzoyl Peroxide Gel|A pea-sized amount, ~0.5 grams, will be applied to a 10cm strip over the deltopectoral interval beginning the morning 48 hours prior to schedule research visit to obtain cultures. The benzoyl peroxide will be applied on dry skin after a shower. The gel will be applied once in the morning and once in the evening for two consecutive days as well as the morning of the scheduled research visit. Following treatment, a skin swab culture of the treatment shoulder will be taken, both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder.
10802945|NCT04300010|FG002|Participant Flow|Light and Gel|Prior to treatment, a skin swab culture will be taken, 5% topical benzoyl peroxide treatment will be performed on dry skin immediately after a shower as described in the above paragraph. Again, five total treatments will be performed prior to research visit. On the day of the research visit, the blue light therapy protocol described above will be performed exactly the same followed by culture obtainment.
10802946|NCT04300010|FG003|Participant Flow|Control Shoulder|All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only)
10802947|NCT04300010|OG000|Outcome|Blue Light Therapy|Blue Light Therapy: Blue light therapy treatment for acne
10802948|NCT04300010|OG001|Outcome|5% Topical Benzoyl Peroxide Gel|5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
10802949|NCT04300010|OG002|Outcome|Light and Gel|"5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne~Blue Light Therapy: Blue light therapy treatment for acne"
10802950|NCT04300010|EG000|Reported Event|Blue Light Therapy|Blue Light Therapy: Blue light therapy treatment for acne
10802951|NCT04300010|EG001|Reported Event|5% Topical Benzoyl Peroxide Gel|5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
10802952|NCT04300010|EG002|Reported Event|Light and Gel|"5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne~Blue Light Therapy: Blue light therapy treatment for acne"
10802953|NCT04300010|EG003|Reported Event|Control Shoulder|All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only)
10802954|NCT04206670|BG000|Baseline|In-Home Technology System|"Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10803905|NCT01146652|OG000|Outcome|PFS-S Sarilumab 150 mg q2w|From Week 24 of main study, eligible participants entered sub-study and received sarilumab 150 mg SC q2w for 12 weeks (i.e., from main study Week 24 to Week 36) using PFS-S.
10803906|NCT01146652|OG001|Outcome|PFS-S Sarilumab 200 mg q2w|From Week 24 of main study, eligible participants entered sub-study and received sarilumab 200 mg SC q2w for 12 weeks (i.e., from main study Week 24 to Week 36) using PFS-S.
11195869|NCT02161146|FG002|Participant Flow|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
11383425|NCT02158091|FG000|Participant Flow|Phase I Cohort 1: IPI-145 25mg Once Daily + FCR|Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383426|NCT02158091|FG001|Participant Flow|Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR|Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383427|NCT02158091|FG002|Participant Flow|Phase II Dose Expansion(RP2D)-IPI-145 25mg Twice Daily + FCR|Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383428|NCT02158091|OG000|Outcome|Phase I Cohort 1: IPI-145 25mg Once Daily + FCR|Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383429|NCT02158091|OG001|Outcome|Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR|Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383430|NCT02158091|OG000|Outcome|Phase I MTD and Phase II RP2D: IPI 145 25 mg BID + FCR|Phase I Cohort 2 (MTD) patients and Dose Expansion patients (RP2D) received oral agent IPI-145 25mg twice daily (BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383431|NCT02158091|EG000|Reported Event|Phase 1 Cohort 1: IPI-145 25mg Once Daily + FCR|Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383432|NCT02158091|EG001|Reported Event|Phase 1 Cohort 2: IPI-145 25mg Twice Daily + FCR|Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11383433|NCT02158091|EG002|Reported Event|Phase II Dose Expansion(MTD)-IPI-145 25mg Twice Daily + FCR|Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11195870|NCT02161146|FG003|Participant Flow|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
11195871|NCT02161146|FG004|Participant Flow|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
11195872|NCT02161146|OG000|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
11195873|NCT02161146|OG001|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
11383434|NCT02139436|BG000|Baseline|FES-row-training|"Subjects will perform 6 months of FES-row-training.~FES-row-training"
11195874|NCT02161146|OG002|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
11383435|NCT02139436|BG001|Baseline|Wait-list Time Control|"Subjects perform 6 months of their standard of care~Time Control"
11383436|NCT02139436|BG002|Baseline|Arms-only-row-training|"Subjects will perform 6 months of arms-only row training~Arms-only-row training"
11383437|NCT02139436|BG003|Baseline|Total|Total of all reporting groups
11383438|NCT02139436|FG000|Participant Flow|FES-row-training|"Subjects will perform 6 months of FES-row-training.~FES-row-training"
11383439|NCT02139436|FG001|Participant Flow|Wait-list Time Control|"Subjects perform 6 months of their standard of care~Time Control"
11383440|NCT02139436|FG002|Participant Flow|Arms-only-row-training|"Subjects will perform 6 months of arms-only row training~Arms-only-row training"
11383441|NCT02139436|OG000|Outcome|Waitlist Controls|Controls (no structured exercise)
11383442|NCT02139436|OG001|Outcome|Arms Only|Arms Only Rowing
11383443|NCT02139436|OG002|Outcome|FES-Rowing|Functional Electrical Stimulation Rowing
11383444|NCT02139436|OG000|Outcome|Waitlist|Subjects continued with standard of care and did not perform and structured exercise
10794169|NCT01994382|BG000|Baseline|Phase 1: Cerdulatinib 15 mg QD|Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
11195875|NCT02161146|EG000|Reported Event|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
11195876|NCT02161146|EG001|Reported Event|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
11195877|NCT02161146|EG002|Reported Event|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
11195878|NCT02161146|EG003|Reported Event|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
11195879|NCT02161146|EG004|Reported Event|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
11195880|NCT02161185|BG000|Baseline|USL261|USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
11195881|NCT02161185|FG000|Participant Flow|USL261|USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
11195882|NCT02161185|OG000|Outcome|USL261|USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
11195883|NCT02161185|EG000|Reported Event|USL261|USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
11195884|NCT02161406|BG000|Baseline|Abatacept|"125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension~Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks"
11195885|NCT02161406|BG001|Baseline|Placebo|"125mg Placebo~Placebo: 125 mg of Placebo"
11195886|NCT02161406|BG002|Baseline|Total|Total of all reporting groups
11383445|NCT02139436|OG001|Outcome|FES Rowing|Subjects that performed FES-rowing
11383446|NCT02139436|OG002|Outcome|Arms-Only Rowing|Subjects that only performed Arms-only rowing
11383447|NCT02139436|OG000|Outcome|FES-row-training|"Subjects will perform 6 months of FES-row-training.~FES-row-training"
11383448|NCT02139436|OG001|Outcome|Wait-list Time Control|"Subjects perform 6 months of their standard of care~Time Control"
11383449|NCT02139436|OG002|Outcome|Arms-only-row-training|"Subjects will perform 6 months of arms-only row training~Arms-only-row training"
11383450|NCT02139436|EG000|Reported Event|FES-row-training|"Subjects will perform 6 months of FES-row-training.~FES-row-training"
11383451|NCT02139436|EG001|Reported Event|Wait-list Time Control|"Subjects perform 6 months of their standard of care~Time Control"
11383452|NCT02139436|EG002|Reported Event|Arms-only-row-training|"Subjects will perform 6 months of arms-only row training~Arms-only-row training"
11383453|NCT02120079|BG000|Baseline|Lotemax|"Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383454|NCT02120079|BG001|Baseline|Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)|"Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383455|NCT02120079|BG002|Baseline|Total|Total of all reporting groups
10794170|NCT01994382|BG001|Baseline|Phase 1: Cerdulatinib 30 mg QD|Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794171|NCT01994382|BG002|Baseline|Phase 1: Cerdulatinib 45 mg QD|Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794172|NCT01994382|BG003|Baseline|Phase 1: Cerdulatinib 15 mg BID|Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794173|NCT01994382|BG004|Baseline|Phase 1: Cerdulatinib 40 mg QD|Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794174|NCT01994382|BG005|Baseline|Phase 1: Cerdulatinib 20 mg BID|Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794175|NCT01994382|BG006|Baseline|Phase 1: Cerdulatinib 50 mg QD|Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794176|NCT01994382|BG007|Baseline|Phase 1: Cerdulatinib 65 mg QD|Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794177|NCT01994382|BG008|Baseline|Phase 1: Cerdulatinib 100 mg QD|Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794178|NCT01994382|BG009|Baseline|Phase 1: Cerdulatinib 45 mg BID|Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794179|NCT01994382|BG010|Baseline|Phase 2a: Cerdulatinib (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794180|NCT01994382|BG011|Baseline|Phase 2a: Cerdulatinib (MZL/WM Cohort)|Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794181|NCT01994382|BG012|Baseline|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
10794182|NCT01994382|BG013|Baseline|Phase 2a: Cerdulatinib (aNHL Cohort)|Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794183|NCT01994382|BG014|Baseline|Phase 2a: Cerdulatinib (CLL/SLL Cohort)|Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794184|NCT01994382|BG015|Baseline|Phase 2a: Cerdulatinib (PTCL Cohort)|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794185|NCT01994382|BG016|Baseline|Phase 2a: Cerdulatinib (CTCL Cohort)|Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794186|NCT01994382|BG017|Baseline|Total|Total of all reporting groups
10794187|NCT01994382|FG000|Participant Flow|Phase 1: Cerdulatinib 15 Milligrams (mg) Once Daily (QD)|Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
10794188|NCT01994382|FG001|Participant Flow|Phase 1: Cerdulatinib 30 mg QD|Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794189|NCT01994382|FG002|Participant Flow|Phase 1: Cerdulatinib 45 mg QD|Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794190|NCT01994382|FG003|Participant Flow|Phase 1: Cerdulatinib 15 mg Twice Daily (BID)|Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794191|NCT01994382|FG004|Participant Flow|Phase 1: Cerdulatinib 40 mg QD|Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794192|NCT01994382|FG005|Participant Flow|Phase 1: Cerdulatinib 20 mg BID|Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794193|NCT01994382|FG006|Participant Flow|Phase 1: Cerdulatinib 50 mg QD|Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794194|NCT01994382|FG007|Participant Flow|Phase 1: Cerdulatinib 65 mg QD|Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794195|NCT01994382|FG008|Participant Flow|Phase 1: Cerdulatinib 100 mg QD|Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794196|NCT01994382|FG009|Participant Flow|Phase 1: Cerdulatinib 45 mg BID|Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794197|NCT01994382|FG010|Participant Flow|Phase 2a: Cerdulatinib (FL Cohort)|Participants with follicular lymphoma (FL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794198|NCT01994382|FG011|Participant Flow|Phase 2a: Cerdulatinib (MZL/WM Cohort)|Participants with marginal zone lymphoma/Waldenström's macroglobulinemia (MZL/WM) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794199|NCT01994382|FG012|Participant Flow|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received intravenous (IV) injections of rituximab 375 milligrams (mg)/square meter (m^2) on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
10794200|NCT01994382|FG013|Participant Flow|Phase 2a: Cerdulatinib (aNHL Cohort)|Participants with aggressive non-Hodgkin lymphoma (aNHL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794201|NCT01994382|FG014|Participant Flow|Phase 2a: Cerdulatinib (CLL/SLL Cohort)|Participants with chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL/SLL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794202|NCT01994382|FG015|Participant Flow|Phase 2a: Cerdulatinib (PTCL Cohort)|Participants with peripheral T-cell lymphoma (PTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794203|NCT01994382|FG016|Participant Flow|Phase 2a: Cerdulatinib (CTCL Cohort)|Participants with cutaneous T-cell lymphoma (CTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794204|NCT01994382|OG000|Outcome|Phase 1: Cerdulatinib 15 mg QD|Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
10794205|NCT01994382|OG001|Outcome|Phase 1: Cerdulatinib 30 mg QD|Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794206|NCT01994382|OG002|Outcome|Phase 1: Cerdulatinib 45 mg QD|Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794207|NCT01994382|OG003|Outcome|Phase 1: Cerdulatinib 15 mg BID|Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794208|NCT01994382|OG004|Outcome|Phase 1: Cerdulatinib 40 mg QD|Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794209|NCT01994382|OG005|Outcome|Phase 1: Cerdulatinib 20 mg BID|Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794210|NCT01994382|OG006|Outcome|Phase 1: Cerdulatinib 50 mg QD|Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794211|NCT01994382|OG007|Outcome|Phase 1: Cerdulatinib 65 mg QD|Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794212|NCT01994382|OG008|Outcome|Phase 1: Cerdulatinib 100 mg QD|Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794213|NCT01994382|OG009|Outcome|Phase 1: Cerdulatinib 45 mg BID|Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794214|NCT01994382|OG000|Outcome|Phase 2a: Cerdulatinib (FL Cohort) With ≤3 Prior Regimen|Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
10794215|NCT01994382|OG001|Outcome|Phase 2a: Cerdulatinib (FL Cohort) With ≥4 Prior Regimen|Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
10794216|NCT01994382|OG002|Outcome|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≤3 Prior Regimen|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
10794217|NCT01994382|OG003|Outcome|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≥4 Prior Regimen|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
10794218|NCT01994382|OG004|Outcome|Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
10794219|NCT01994382|OG005|Outcome|Phase 2a: Cerdulatinib (PTCL Cohort) With NOS|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL not otherwise specified (NOS).
11195887|NCT02161406|FG000|Participant Flow|Abatacept|"125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension~Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks"
11383456|NCT02120079|FG000|Participant Flow|Lotemax|"Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383457|NCT02120079|FG001|Participant Flow|Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)|"Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383458|NCT02120079|OG000|Outcome|Lotemax|"Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383459|NCT02120079|OG001|Outcome|Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)|"Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383460|NCT02120079|OG000|Outcome|Lotemax|"Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch & Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383461|NCT02120079|EG000|Reported Event|Lotemax|"Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of"
11383462|NCT02120079|EG001|Reported Event|Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)|"Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.~In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus."
11383463|NCT02106195|BG000|Baseline|Belumosudil 200 mg PO QD|Belumosudil 200 mg (two 100 mg capsules) orally once daily for 28 days
11383464|NCT02106195|FG000|Participant Flow|Belumosudil 200 mg PO QD|8 subjects with moderately severe psoriasis who had failed at least 1 line of systemic therapy administered belumosudil 200 mg orally QD for 4 weeks
11195888|NCT02161406|FG001|Participant Flow|Placebo|"125mg Placebo~Placebo: 125 mg of Placebo"
10794220|NCT01994382|OG006|Outcome|Phase 2a: Cerdulatinib (PTCL Cohort) With Other|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of other PTCL pathology subgroups not included in AITL/TFH or NOS subgroups.
10794221|NCT01994382|OG010|Outcome|Phase 2a: Cerdulatinib (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794222|NCT01994382|OG011|Outcome|Phase 2a: Cerdulatinib (MZL/WM Cohort)|Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794223|NCT01994382|OG012|Outcome|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
10794224|NCT01994382|OG013|Outcome|Phase 2a: Cerdulatinib (aNHL Cohort)|Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794225|NCT01994382|OG014|Outcome|Phase 2a: Cerdulatinib (CLL/SLL Cohort)|Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794226|NCT01994382|OG015|Outcome|Phase 2a: Cerdulatinib (PTCL Cohort)|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794227|NCT01994382|OG016|Outcome|Phase 2a: Cerdulatinib (CTCL Cohort)|Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
10794228|NCT01994382|EG000|Reported Event|Phase 1: Cerdulatinib 15 mg QD|Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
10794229|NCT01994382|EG001|Reported Event|Phase 1: Cerdulatinib 30 mg QD|Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794230|NCT01994382|EG002|Reported Event|Phase 1: Cerdulatinib 45 mg QD|Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794231|NCT01994382|EG003|Reported Event|Phase 1: Cerdulatinib 15 mg BID|Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794232|NCT01994382|EG004|Reported Event|Phase 1: Cerdulatinib 40 mg QD|Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794233|NCT01994382|EG005|Reported Event|Phase 1: Cerdulatinib 20 mg BID|Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794234|NCT01994382|EG006|Reported Event|Phase 1: Cerdulatinib 50 mg QD|Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
11195889|NCT02161406|OG000|Outcome|Abatacept|"125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension~Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks"
11195890|NCT02161406|OG001|Outcome|Placebo|"125mg Placebo~Placebo: 125 mg of Placebo"
10794235|NCT01994382|EG007|Reported Event|Phase 1: Cerdulatinib 65 mg QD|Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794236|NCT01994382|EG008|Reported Event|Phase 1: Cerdulatinib 100 mg QD|Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
10794237|NCT01994382|EG009|Reported Event|Phase 1: Cerdulatinib 45 mg BID|Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
10794238|NCT01994382|EG010|Reported Event|Phase 2a: Cerdulatinib (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794239|NCT01994382|EG011|Reported Event|Phase 2a: Cerdulatinib (MZL/WM Cohort)|Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
11195891|NCT02161406|EG000|Reported Event|Abatacept|"125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension~Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks"
11195892|NCT02161406|EG001|Reported Event|Placebo|"125mg Placebo~Placebo: 125 mg of Placebo"
11383465|NCT02106195|OG000|Outcome|Belumosudil 200 mg PO QD|Subjects who received at least 1 dose of belumosudil 200 mg orally daily
10794240|NCT01994382|EG012|Reported Event|Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)|Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
10794241|NCT01994382|EG013|Reported Event|Phase 2a: Cerdulatinib (aNHL Cohort)|Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794242|NCT01994382|EG014|Reported Event|Phase 2a: Cerdulatinib (CLL/SLL Cohort)|Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794243|NCT01994382|EG015|Reported Event|Phase 2a: Cerdulatinib (PTCL Cohort)|Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794244|NCT01994382|EG016|Reported Event|Phase 2a: Cerdulatinib (CTCL Cohort)|Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
10794245|NCT01896531|BG000|Baseline|Ipatasertib + mFOLFOX6|Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10794246|NCT01896531|BG001|Baseline|Placebo + mFOLFOX6|Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10794247|NCT01896531|BG002|Baseline|Total|Total of all reporting groups
10794248|NCT01896531|FG000|Participant Flow|Ipatasertib + mFOLFOX6|Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10794249|NCT01896531|FG001|Participant Flow|Placebo + mFOLFOX6|Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10794250|NCT01896531|OG000|Outcome|Ipatasertib + mFOLFOX6|Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10794251|NCT01896531|OG001|Outcome|Placebo + mFOLFOX6|Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10803907|NCT01146652|OG002|Outcome|PFS-S Sarilumab 200 to 150 mg q2w|From Week 24 of main study, eligible participants entered sub-study and received sarilumab 200 mg SC q2w for 12 weeks (i.e., from main study Week 24 to Week 36) using PF-S. The dose might be reduced to 150 mg q2w due to neutropenia, thrombocytopenia, or an increase in liver enzymes.
11241206|NCT02485483|BG000|Baseline|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
10794252|NCT01896531|EG000|Reported Event|Ipatasertib + mFOLFOX6|Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
11195893|NCT02161458|BG000|Baseline|Escitalopram 20mg for 2 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 2 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195894|NCT02161458|BG001|Baseline|Placebo (Sugar Pill)|"30 cognitively normal adults aged 60-85 will receive placebo for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days) or 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 or 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Placebo: Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration."
11195895|NCT02161458|BG002|Baseline|Escitalopram 30mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 5 days; then 30 mg for 46 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 30mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11383466|NCT02106195|OG000|Outcome|Belumosudil 200 mg PO QD|Subjects receiving 200 mg of belumosudil daily
11195896|NCT02161458|BG003|Baseline|Escitalopram 20mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11383467|NCT02106195|OG000|Outcome|Belumosudil 200 mg PO QD|Subjects receiving belumosudil 200 mg orally once daily for up to 28 days
11383468|NCT02106195|OG000|Outcome|Parent Drug KD025|Study drug belumosudil
11383469|NCT02106195|OG001|Outcome|Metabolite M1|Metabolite KD025 M1 of parent drug KD025.
11383470|NCT02106195|OG002|Outcome|Metabolite M2|Metabolite KD025 M2 of parent drug KD025.
11195897|NCT02161458|BG004|Baseline|Total|Total of all reporting groups
11202233|NCT02206607|FG001|Participant Flow|Sequence ADBC: PF-04937319 150+100 mg IR First|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.
11383471|NCT02106195|OG001|Outcome|Metabolite M2|Metabolite KD025 M2 of parent drug KD025.
11383472|NCT02106195|EG000|Reported Event|Belumosudil 200 mg PO QD|Subjects who received belumosudil 200 mg orally daily
11383473|NCT02104180|BG000|Baseline|TulleGras MS - Urgotul|Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
11383474|NCT02104180|BG001|Baseline|Urgotul - TulleGras M.S.|Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
11383475|NCT02104180|BG002|Baseline|Total|Total of all reporting groups
11383476|NCT02104180|FG000|Participant Flow|TulleGras MS - Urgotul|Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
11383477|NCT02104180|FG001|Participant Flow|Urgotul - TulleGras MS|Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
11383478|NCT02104180|OG000|Outcome|TulleGras M.S.|TulleGras M.S.: Sterile dressing that consists of viscose tissue coated with mineral vaseline
11383479|NCT02104180|OG001|Outcome|Urgotul|Urgotul: sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
11383480|NCT02104180|EG000|Reported Event|TulleGras MS - Urgotul|Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks
11383481|NCT02104180|EG001|Reported Event|Urgotul - TulleGras MS|Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks
11383482|NCT02066181|BG000|Baseline|Arm I (Sorafenib Tosylate)|Patients receive sorafenib tosylate PO QD on days 1-28.
11383483|NCT02066181|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
11383484|NCT02066181|BG002|Baseline|Total|Total of all reporting groups
11383485|NCT02066181|FG000|Participant Flow|Arm I (Sorafenib Tosylate)|Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day
10794253|NCT01896531|EG001|Reported Event|Placebo + mFOLFOX6|Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued.
10802955|NCT04206670|BG001|Baseline|Waiting Control|"Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802956|NCT04206670|BG002|Baseline|Total|Total of all reporting groups
10802957|NCT04206670|FG000|Participant Flow|In-Home Technology System|"Participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802958|NCT04206670|FG001|Participant Flow|Waiting Control|"Participants will be assigned to receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) after they enter the study. During a 6-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional 6-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).~Waiting Control In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802959|NCT04206670|OG000|Outcome|In-Home Technology System|"Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802960|NCT04206670|OG001|Outcome|Waiting Control|"Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10794254|NCT01864603|BG000|Baseline|Intervention|Intervention arm first stage: Annual universal community- based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care
10794255|NCT01864603|BG001|Baseline|Control|Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
10794256|NCT01864603|BG002|Baseline|Total|Total of all reporting groups
10794257|NCT01864603|FG000|Participant Flow|Intervention|"Intervention arm first stage: annual universal community-based HIV and multi-disease testing; ART for all HIV+; ART delivery using streamlined patient-centered care~Intervention arm second stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP"
10794258|NCT01864603|FG001|Participant Flow|Control|"Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care~Active Comparator arm second stage"
10794259|NCT01864603|OG000|Outcome|Intervention|Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care
10794260|NCT01864603|OG001|Outcome|Control|Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
10794261|NCT01864603|OG000|Outcome|Intervention|Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP
10794262|NCT01864603|OG000|Outcome|Intervention|Patient-centered Phone call
10794263|NCT01864603|OG001|Outcome|Control|Standard of Care
11202234|NCT02206607|FG002|Participant Flow|Sequence BACD: PF-04937319 250 mg MR1 First|Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794264|NCT01864603|OG000|Outcome|Intervention Year 1|Third year of Stage 1 intervention
10794265|NCT01864603|OG001|Outcome|Intervention Year 3|First year of Stage 1 Intervention: Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care
10794266|NCT01864603|EG000|Reported Event|Intervention Arm Stage 1|"Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care~Adverse events monitored among persons initiating ART outside of National guidelines"
10794267|NCT01864603|EG001|Reported Event|Intervention Arm Stage II|"Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP~Adverse events monitored among persons initiating PrEP"
10802961|NCT04206670|OG001|Outcome|Waiting Control|"Participants (N=100) will be assigned to receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) after they enter the study. During a 6-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional 6-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).~Waiting Control In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802962|NCT04206670|EG000|Reported Event|In-Home Technology System|"Participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).~In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802963|NCT04206670|EG001|Reported Event|Waiting Control|"Participants will be assigned to receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) after they enter the study. During a 6-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional 6-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).~Waiting Control In-Home Technology System and Questionnaires: Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment."
10802964|NCT04173962|BG000|Baseline|Ketamine Group|"One 0.5mg/kg intravenous dose of ketamine~Ketamine: administered 1 week prior to a laboratory-induced stress"
11383486|NCT02066181|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
10794268|NCT01399658|BG000|Baseline|Image-Guided Brachytherapy|"Image-guided brachytherapy~Image-guided brachytherapy: MRI-guided application of brachytherapy~3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer"
10794269|NCT01399658|FG000|Participant Flow|Image-Guided Brachytherapy|"Image-guided brachytherapy~Image-guided brachytherapy: MRI-guided application of brachytherapy~3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer"
10794270|NCT01399658|OG000|Outcome|Image-Guided Brachytherapy|"Image-guided brachytherapy~Image-guided brachytherapy: MRI-guided application of brachytherapy~3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer"
10794271|NCT01399658|EG000|Reported Event|Image-Guided Brachytherapy|"Image-guided brachytherapy~Image-guided brachytherapy: MRI-guided application of brachytherapy~3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer"
10794272|NCT01397968|BG000|Baseline|YKP3089|YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day
10794273|NCT01397968|BG001|Baseline|Placebo|Placebo: capsule, dose to be titrated to a target dose of 200mg/day
10794274|NCT01397968|BG002|Baseline|Total|Total of all reporting groups
10794275|NCT01397968|FG000|Participant Flow|YKP3089|YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day
10794276|NCT01397968|FG001|Participant Flow|Placebo|Placebo: capsule, dose to be titrated to a target dose of 200mg/day
10794277|NCT01397968|OG000|Outcome|YKP3089|YKP3089: Capsule, dose to be titrated Tablet, dose to be titrated
10794278|NCT01397968|OG001|Outcome|Placebo|Placebo: Placebo capsule Placebo tablet
10794279|NCT01397968|OG000|Outcome|YKP3089|YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day
10794280|NCT01397968|OG001|Outcome|Placebo|Placebo: capsule, dose to be titrated to a target dose of 200mg/day
10794281|NCT01397968|EG000|Reported Event|YKP3089|YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day
10794282|NCT01397968|EG001|Reported Event|Placebo|Placebo: capsule, dose to be titrated to a target dose of 200mg/day
10794283|NCT01365195|BG000|Baseline|Control|"Loading and Infusion:~Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate"
10794284|NCT01365195|BG001|Baseline|Ketamine Low-dose|Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
10794285|NCT01365195|BG002|Baseline|Ketamine High-dose|Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
10794286|NCT01365195|BG003|Baseline|Total|Total of all reporting groups
10794287|NCT01365195|FG000|Participant Flow|Control|"Loading and Infusion:~Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate"
10794288|NCT01365195|FG001|Participant Flow|Ketamine Low-dose|Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
10794289|NCT01365195|FG002|Participant Flow|Ketamine High-dose|Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
10794290|NCT01365195|OG000|Outcome|Control|"Loading and Infusion:~Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate"
10794291|NCT01365195|OG001|Outcome|Ketamine Low-dose|Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
10794292|NCT01365195|OG002|Outcome|Ketamine High-dose|Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
10794293|NCT01365195|EG000|Reported Event|Control|"Loading and Infusion:~Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate"
10794294|NCT01365195|EG001|Reported Event|Ketamine Low-dose|Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
10794295|NCT01365195|EG002|Reported Event|Ketamine High-dose|Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
10794296|NCT00966953|BG000|Baseline|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
10794297|NCT00966953|BG001|Baseline|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
10794298|NCT00966953|BG002|Baseline|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
10794299|NCT00966953|BG003|Baseline|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
10794300|NCT00966953|BG004|Baseline|Total|Total of all reporting groups
10794301|NCT00966953|FG000|Participant Flow|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
10794302|NCT00966953|FG001|Participant Flow|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
10794303|NCT00966953|FG002|Participant Flow|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
10794304|NCT00966953|FG003|Participant Flow|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
10794305|NCT00966953|OG000|Outcome|Fluoride Only|Control toothopaste
10794306|NCT00966953|OG001|Outcome|Total/Whitening|Control toothpaste
10794307|NCT00966953|OG002|Outcome|Herbal Extract Toothpaste|Fluoride/Honokiol extract toothpaste
10794308|NCT00966953|OG003|Outcome|Herbal Extract Toothpaste|Fluoride/Magnolol extract toothpaste
10794309|NCT00961805|BG000|Baseline|Group Control|The waiting list
10794310|NCT00961805|BG001|Baseline|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
10794311|NCT00961805|BG002|Baseline|Total|Total of all reporting groups
10794312|NCT00961805|FG000|Participant Flow|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
11202235|NCT02206607|FG003|Participant Flow|Sequence CBDA: PF-04937319 300 mg MR2 First|Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.
11383487|NCT02066181|OG000|Outcome|Arm I (Sorafenib Tosylate)|Patients receive sorafenib tosylate PO QD on days 1-28, 400 mg/day.
11383488|NCT02066181|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
11383489|NCT02066181|OG000|Outcome|Arm I (Sorafenib Tosylate)|Patients receive sorafenib tosylate PO QD on days 1-28.
11383490|NCT02066181|OG002|Outcome|Crossover Patients|After progression from Arm II(Placebo), patients receive sorafenib tosylate PO QD on days 1-28. These patients are per protocol, excluded/censored from secondary analysis and endpoints.
11383491|NCT02066181|EG000|Reported Event|Arm I (Sorafenib Tosylate)|Patients receive sorafenib tosylate PO QD on days 1-28.
11383492|NCT02066181|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
11383493|NCT02066181|EG002|Reported Event|Crossover Group|Upon disease progression, patients treated with placebo will be allowed to crossover to the open label sorafenib arm.
11383494|NCT02050919|BG000|Baseline|Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)|"Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.~Epirubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sorafenib Tosylate: Given PO~Therapeutic Conventional Surgery: Undergo surgical resection"
11383495|NCT02050919|FG000|Participant Flow|Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)|"Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.~Epirubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sorafenib Tosylate: Given PO~Therapeutic Conventional Surgery: Undergo surgical resection"
11383496|NCT02050919|OG000|Outcome|Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)|"Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.~Epirubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sorafenib Tosylate: Given PO~Therapeutic Conventional Surgery: Undergo surgical resection"
11383497|NCT02050919|EG000|Reported Event|Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)|"Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.~Epirubicin Hydrochloride: Given IV~External Beam Radiation Therapy: Undergo EBRT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sorafenib Tosylate: Given PO~Therapeutic Conventional Surgery: Undergo surgical resection"
11383498|NCT02040857|BG000|Baseline|Palbociclib With Adjuvant Endocrine Therapy|"Palbociclib 125 mg PO qd 21 days on, 7 days off~Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd"
11383499|NCT02040857|FG000|Participant Flow|Palbociclib With Adjuvant Endocrine Therapy|Palbociclib: 125 mg PO qd 21 days on, 7 days off Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
11383500|NCT02040857|OG000|Outcome|Palbociclib With Adjuvant Endocrine Therapy|"Palbociclib 125 mg PO qd 21 days on, 7 days off~Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd"
11383501|NCT02040857|OG000|Outcome|Aromatase Inhibitor + Palbociclib|participants who received an Aromatase inhibitor as their endocrine therapy with Palbociclib
11383502|NCT02040857|OG001|Outcome|Tamoxifen + Palbociclib|participants who received Tamoxifen as their endocrine therapy with Palbociclib
11383503|NCT02040857|OG000|Outcome|Palbociclib With Adjuvant Endocrine Therapy|Palbociclib: 125 mg PO qd 21 days on, 7 days off Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
11383504|NCT02040857|EG000|Reported Event|Palbociclib With Adjuvant Endocrine Therapy|"Palbociclib 125 mg PO qd 21 days on, 7 days off~Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd"
11383505|NCT01997463|BG000|Baseline|Regular Therapy|Regular Asthma Therapy
11383506|NCT01997463|BG001|Baseline|Supervised Therapy|"Supervised asthma therapy in schools~Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association"
11383507|NCT01997463|BG002|Baseline|Total|Total of all reporting groups
11383508|NCT01997463|FG000|Participant Flow|Regular Therapy|Regular Asthma Therapy
11383509|NCT01997463|FG001|Participant Flow|Supervised Therapy|"Supervised asthma therapy in schools~Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association"
11383510|NCT01997463|OG000|Outcome|Regular Therapy|Regular Asthma Therapy
11202236|NCT02206607|FG004|Participant Flow|Sequence DCAB: PF-04937319 330 mg MR3 First|Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.
11383511|NCT01997463|OG001|Outcome|Supervised Therapy|"Supervised asthma therapy in schools~Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association"
11383512|NCT01997463|EG000|Reported Event|Regular Therapy|Regular Asthma Therapy
10794313|NCT00961805|FG001|Participant Flow|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
10794314|NCT00961805|OG000|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
10794315|NCT00961805|OG001|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
10794316|NCT00950937|BG000|Baseline|HIV Group|HIV infected persons
10794317|NCT00950937|BG001|Baseline|Control Group|Non HIV-infected persons
10794318|NCT00950937|BG002|Baseline|Total|Total of all reporting groups
10794319|NCT00950937|FG000|Participant Flow|HIV Group|HIV infected persons
10794320|NCT00950937|FG001|Participant Flow|Control Group|Non HIV-infected persons
10794321|NCT00950937|OG000|Outcome|HIV Group|HIV infected persons
10794322|NCT00950937|OG001|Outcome|Control Group|Non HIV-infected persons
10794323|NCT00948753|BG000|Baseline|Phase 1: 150mg Maraviroc|"150mg twice daily~Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
11202237|NCT02206607|OG000|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794324|NCT00948753|BG001|Baseline|Phase 1: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794325|NCT00948753|BG002|Baseline|Phase 2: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794326|NCT00948753|BG003|Baseline|Total|Total of all reporting groups
10794327|NCT00948753|FG000|Participant Flow|Phase 1: 150mg Maraviroc|"150mg twice daily~Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794328|NCT00948753|FG001|Participant Flow|Phase 1: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794329|NCT00948753|FG002|Participant Flow|Phase 2: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794330|NCT00948753|OG000|Outcome|Phase 1: 150mg Maraviroc|"150mg twice daily~Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794331|NCT00948753|OG001|Outcome|Phase 1: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794332|NCT00948753|OG002|Outcome|Phase 2: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794333|NCT00948753|OG002|Outcome|Phase 2: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg Phase II: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794334|NCT00948753|EG000|Reported Event|Phase 1: 150mg Maraviroc|"150mg twice daily~Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794335|NCT00948753|EG001|Reported Event|Phase 1: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794336|NCT00948753|EG002|Reported Event|Phase 2: 300mg Maraviroc|"300mg twice daily~Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion."
10794337|NCT00947518|BG000|Baseline|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
10794338|NCT00947518|BG001|Baseline|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
10794339|NCT00947518|BG002|Baseline|No Skin Cleansing|No skin application
10794340|NCT00947518|BG003|Baseline|Total|Total of all reporting groups
10802965|NCT04173962|BG001|Baseline|Midazolam Group|"One 0.045mg/kg intravenous dose of midazolam~Midazolam: administered 1 week prior to a laboratory-induced stress"
10794341|NCT00947518|FG000|Participant Flow|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
10794342|NCT00947518|FG001|Participant Flow|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
10794343|NCT00947518|FG002|Participant Flow|No Skin Cleansing|No skin application
10794344|NCT00947518|OG000|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
10794345|NCT00947518|OG001|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
10794346|NCT00947518|OG002|Outcome|No Skin Cleansing|No skin application
10802966|NCT04173962|BG002|Baseline|Total|Total of all reporting groups
10802967|NCT04173962|FG000|Participant Flow|Ketamine Group|"One 0.5mg/kg intravenous dose of ketamine~Ketamine: administered 1 week prior to a laboratory-induced stress"
10802968|NCT04173962|FG001|Participant Flow|Midazolam Group|"One 0.045mg/kg intravenous dose of midazolam~Midazolam: administered 1 week prior to a laboratory-induced stress"
10802969|NCT04173962|OG000|Outcome|Ketamine Group|"One 0.5mg/kg intravenous dose of ketamine~Ketamine: administered 1 week prior to a laboratory-induced stress"
10802970|NCT04173962|OG001|Outcome|Midazolam Group|"One 0.045mg/kg intravenous dose of midazolam~Midazolam: administered 1 week prior to a laboratory-induced stress"
10802971|NCT04173962|EG000|Reported Event|Ketamine Group|"One 0.5mg/kg intravenous dose of ketamine~Ketamine: administered 1 week prior to a laboratory-induced stress"
10802972|NCT04173962|EG001|Reported Event|Midazolam Group|"One 0.045mg/kg intravenous dose of midazolam~Midazolam: administered 1 week prior to a laboratory-induced stress"
10802973|NCT04115189|BG000|Baseline|Sunitinib: Switched From 4/2 to 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802974|NCT04115189|BG001|Baseline|Sunitinib 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
10802975|NCT04115189|BG002|Baseline|Total|Total of all reporting groups
10802976|NCT04115189|FG000|Participant Flow|Sunitinib: Switched From 4/2 to 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802977|NCT04115189|FG001|Participant Flow|Sunitinib 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
10802978|NCT04115189|OG000|Outcome|Sunitinib: Switched From 4/2 to 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802979|NCT04115189|OG001|Outcome|Sunitinib 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
10802980|NCT04115189|OG000|Outcome|Sunitinib: Switched From 4/2 to 2/1 Schedule (4/2 Schedule)|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802981|NCT04115189|OG001|Outcome|Sunitinib: Switched From 4/2 to 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802982|NCT04115189|OG002|Outcome|Sunitinib 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
10802983|NCT04115189|EG000|Reported Event|Sunitinib: Switched From 4/2 to 2/1 Schedule (4/2 Schedule)|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802984|NCT04115189|EG001|Reported Event|Sunitinib: Switched From 4/2 to 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
10802985|NCT04115189|EG002|Reported Event|Sunitinib 2/1 Schedule|Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
10802986|NCT04010695|BG000|Baseline|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
10802987|NCT04010695|FG000|Participant Flow|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff performed the Standard Diagnostics (SD) Biosensor point-of-care (POC) G6PD test assay and the POC HemoCue hemoglobin test on both finger-stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
10794347|NCT00934921|BG000|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
10794348|NCT00934921|BG001|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
10794349|NCT00934921|BG002|Baseline|Total|Total of all reporting groups
10794350|NCT00934921|FG000|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
10794351|NCT00934921|FG001|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
10794352|NCT00934921|OG000|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
10794353|NCT00934921|OG001|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
10794354|NCT00934180|BG000|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
10794355|NCT00934180|BG001|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
10794356|NCT00934180|BG002|Baseline|Total|Total of all reporting groups
10794357|NCT00934180|FG000|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
10794358|NCT00934180|FG001|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
10794359|NCT00934180|OG000|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
10794360|NCT00934180|OG001|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
10794361|NCT00924833|BG000|Baseline|Placebo|Placebo tablets. One tablet twice daily.
10794362|NCT00924833|BG001|Baseline|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
10794363|NCT00924833|BG002|Baseline|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
10794364|NCT00924833|BG003|Baseline|Total|Total of all reporting groups
10794365|NCT00924833|FG000|Participant Flow|Placebo|Placebo tablets. One tablet twice daily.
10794366|NCT00924833|FG001|Participant Flow|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
10794367|NCT00924833|FG002|Participant Flow|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
10794368|NCT00924833|OG000|Outcome|Placebo|Placebo tablets. One tablet twice daily.
10794369|NCT00924833|OG001|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
10794370|NCT00924833|OG002|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
10794371|NCT00919893|BG000|Baseline|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
10794372|NCT00919893|BG001|Baseline|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
10794373|NCT00919893|BG002|Baseline|Total|Total of all reporting groups
10794374|NCT00919893|FG000|Participant Flow|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
10794375|NCT00919893|FG001|Participant Flow|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
10794376|NCT00919893|OG000|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
10794377|NCT00919893|OG001|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
10794378|NCT00912158|BG000|Baseline|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
10794379|NCT00912158|BG001|Baseline|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
10794380|NCT00912158|BG002|Baseline|Standard Treatment|Standard medical therapy alone
10794381|NCT00912158|BG003|Baseline|Total|Total of all reporting groups
10794382|NCT00912158|FG000|Participant Flow|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
10794383|NCT00912158|FG001|Participant Flow|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
10794384|NCT00912158|FG002|Participant Flow|Standard Treatment|Standard medical therapy alone
10794385|NCT00912158|OG000|Outcome|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
10794386|NCT00912158|OG001|Outcome|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
10794387|NCT00912158|OG002|Outcome|Standard Treatment|Standard medical therapy alone
10794388|NCT00911443|BG000|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794389|NCT00911443|BG001|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794390|NCT00911443|BG002|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794391|NCT00911443|BG003|Baseline|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794392|NCT00911443|BG004|Baseline|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794393|NCT00911443|BG005|Baseline|Total|Total of all reporting groups
10794394|NCT00911443|FG000|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794395|NCT00911443|FG001|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794396|NCT00911443|FG002|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794397|NCT00911443|FG003|Participant Flow|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794398|NCT00911443|FG004|Participant Flow|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794399|NCT00911443|OG000|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794400|NCT00911443|OG001|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794401|NCT00911443|OG002|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794402|NCT00911443|OG003|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794403|NCT00911443|OG004|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
10794404|NCT00911274|BG000|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
11202238|NCT02206607|OG001|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
11202239|NCT02206607|OG002|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794405|NCT00911274|BG001|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
10794406|NCT00911274|BG002|Baseline|Total|Total of all reporting groups
10794407|NCT00911274|FG000|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
10794408|NCT00911274|FG001|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
10794409|NCT00911274|OG000|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
10794410|NCT00911274|OG001|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
10794411|NCT00909753|BG000|Baseline|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
10794412|NCT00909753|BG001|Baseline|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
10794413|NCT00909753|BG002|Baseline|Total|Total of all reporting groups
10794414|NCT00909753|FG000|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
10794415|NCT00909753|FG001|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
10794416|NCT00909753|OG000|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
10794417|NCT00909753|OG001|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
10794418|NCT00909649|BG000|Baseline|Fibrin Group|
10794419|NCT00909649|BG001|Baseline|Non Fibrin Group|
10794420|NCT00909649|BG002|Baseline|Total|Total of all reporting groups
10794421|NCT00909649|FG000|Participant Flow|Fibrin Group|
10794422|NCT00909649|FG001|Participant Flow|Non Fibrin Group|
10794423|NCT00909649|OG000|Outcome|Fibrin Group|
10794424|NCT00909649|OG001|Outcome|Non Fibrin Group|
10794425|NCT00909610|BG000|Baseline|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
10794426|NCT00909610|BG001|Baseline|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
10794427|NCT00909610|BG002|Baseline|Total|Total of all reporting groups
10794428|NCT00909610|FG000|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
10794429|NCT00909610|FG001|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
10794430|NCT00909610|OG000|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period
10794431|NCT00909610|OG001|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
10794432|NCT00909610|OG000|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
10794433|NCT00908648|BG000|Baseline|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
10794434|NCT00908648|BG001|Baseline|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
10794435|NCT00908648|BG002|Baseline|Total|Total of all reporting groups
10794436|NCT00908648|FG000|Participant Flow|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
10794437|NCT00908648|FG001|Participant Flow|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
10794438|NCT00908648|OG000|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
10794439|NCT00908648|OG001|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
10794440|NCT00908128|BG000|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794441|NCT00908128|BG001|Baseline|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794442|NCT00908128|BG002|Baseline|Total|Total of all reporting groups
10794443|NCT00908128|FG000|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794444|NCT00908128|FG001|Participant Flow|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794445|NCT00908128|OG000|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
10794446|NCT00908128|OG001|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
10794447|NCT00907907|BG000|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794448|NCT00907907|BG001|Baseline|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794449|NCT00907907|BG002|Baseline|Total|Total of all reporting groups
10794450|NCT00907907|FG000|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794451|NCT00907907|FG001|Participant Flow|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
10794452|NCT00907907|OG000|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
10794453|NCT00907907|OG001|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
10794454|NCT00905606|BG000|Baseline|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period
10794455|NCT00905606|BG001|Baseline|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period
11202240|NCT02206607|OG003|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794456|NCT00905606|BG002|Baseline|Total|Total of all reporting groups
10794457|NCT00905606|FG000|Participant Flow|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.
10794458|NCT00905606|FG001|Participant Flow|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
10794459|NCT00905606|OG000|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
10794460|NCT00905606|OG001|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
10794461|NCT00905567|BG000|Baseline|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
10794462|NCT00905567|BG001|Baseline|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
10794463|NCT00905567|BG002|Baseline|Total|Total of all reporting groups
10794464|NCT00905567|FG000|Participant Flow|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
10794465|NCT00905567|FG001|Participant Flow|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
10794466|NCT00905567|OG000|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
10794467|NCT00905567|OG001|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
10794468|NCT00905346|BG000|Baseline|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
10794469|NCT00905346|BG001|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
10794470|NCT00905346|BG002|Baseline|Total|Total of all reporting groups
10794471|NCT00905346|FG000|Participant Flow|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules 2 x 25 mg (reference) dosed in second period
10794472|NCT00905346|FG001|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
10794473|NCT00905346|OG000|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
10794474|NCT00905346|OG001|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
10794475|NCT00905164|BG000|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
10794476|NCT00905164|BG001|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules,2 x 25 mg (test) dosed in second period
10794477|NCT00905164|BG002|Baseline|Total|Total of all reporting groups
10794478|NCT00905164|FG000|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period
10794479|NCT00905164|FG001|Participant Flow|Topomax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
11202241|NCT02206607|OG000|Outcome|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
10794480|NCT00905164|OG000|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
10794481|NCT00905164|OG001|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
10794482|NCT00904943|BG000|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
10794483|NCT00904943|BG001|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
10794484|NCT00904943|BG002|Baseline|Total|Total of all reporting groups
10794485|NCT00904943|FG000|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
10794486|NCT00904943|FG001|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
10794487|NCT00904943|OG000|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
10794488|NCT00904943|OG001|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
10794489|NCT00890591|BG000|Baseline|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
10794490|NCT00890591|FG000|Participant Flow|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
10794491|NCT00890591|OG000|Outcome|Olmesartan Monotherapy|olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
10794492|NCT00890591|OG000|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
10794493|NCT00890591|OG000|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
10794494|NCT00890591|OG000|Outcome|Olmesartan + Hydrochlorothiazide + Amlodipine|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
10794495|NCT00890409|BG000|Baseline|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
10794496|NCT00890409|BG001|Baseline|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
10794497|NCT00890409|BG002|Baseline|Total|Total of all reporting groups
10794498|NCT00890409|FG000|Participant Flow|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
10794499|NCT00890409|FG001|Participant Flow|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
10794500|NCT00890409|OG000|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
10794501|NCT00890409|OG001|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
10794502|NCT00888355|BG000|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
10794503|NCT00888355|BG001|Baseline|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
10794504|NCT00888355|BG002|Baseline|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
10794505|NCT00888355|BG003|Baseline|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
10794506|NCT00888355|BG004|Baseline|Total|Total of all reporting groups
10794507|NCT00888355|FG000|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
10794508|NCT00888355|FG001|Participant Flow|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
10794509|NCT00888355|FG002|Participant Flow|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
10794510|NCT00888355|FG003|Participant Flow|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
10794511|NCT00888355|OG000|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
10794512|NCT00888355|OG001|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
10794513|NCT00888355|OG002|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
10794514|NCT00888355|OG003|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
10794515|NCT00887250|BG000|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
10794516|NCT00887250|BG001|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
10794517|NCT00887250|BG002|Baseline|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
11202242|NCT02206607|OG001|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794518|NCT00887250|BG003|Baseline|Total|Total of all reporting groups
10794519|NCT00887250|FG000|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
10794520|NCT00887250|FG001|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
10794521|NCT00887250|FG002|Participant Flow|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
10794522|NCT00887250|OG000|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
10794523|NCT00887250|OG001|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
10794524|NCT00887250|OG002|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
10794525|NCT00886600|BG000|Baseline|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794526|NCT00886600|BG001|Baseline|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794527|NCT00886600|BG002|Baseline|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
10794528|NCT00886600|BG003|Baseline|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794529|NCT00886600|BG004|Baseline|Total|Total of all reporting groups
10794530|NCT00886600|FG000|Participant Flow|Placebo / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks~Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
10794531|NCT00886600|FG001|Participant Flow|Losartan 50 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
10794532|NCT00886600|FG002|Participant Flow|Losartan 100 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks"
10794533|NCT00886600|FG003|Participant Flow|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
10794534|NCT00886600|OG000|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794535|NCT00886600|OG001|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794536|NCT00886600|OG002|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
10794537|NCT00886600|OG003|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
10794538|NCT00882440|BG000|Baseline|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
10794539|NCT00882440|BG001|Baseline|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
10794540|NCT00882440|BG002|Baseline|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
10794541|NCT00882440|BG003|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
10794542|NCT00882440|BG004|Baseline|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
10794543|NCT00882440|BG005|Baseline|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
10794544|NCT00882440|BG006|Baseline|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
10794545|NCT00882440|BG007|Baseline|Total|Total of all reporting groups
10794546|NCT00882440|FG000|Participant Flow|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
10794547|NCT00882440|FG001|Participant Flow|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
10794548|NCT00882440|FG002|Participant Flow|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
10794549|NCT00882440|FG003|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
10794550|NCT00882440|FG004|Participant Flow|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
11195898|NCT02161458|FG000|Participant Flow|Escitalopram 20mg for 2 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 2 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195899|NCT02161458|FG001|Participant Flow|Placebo (Sugar Pill)|"30 cognitively normal adults aged 60-85 will receive placebo for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days) or 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 or 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Placebo: Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration."
11195900|NCT02161458|FG002|Participant Flow|Escitalopram 30mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 5 days; then 30 mg for 46 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 30mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
10794551|NCT00882440|FG005|Participant Flow|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
10794552|NCT00882440|FG006|Participant Flow|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
10794553|NCT00882440|OG000|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
10794554|NCT00882440|OG001|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
10794555|NCT00882440|OG002|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
10794556|NCT00882440|OG003|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
10794557|NCT00882440|OG004|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
10794558|NCT00882440|OG005|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
10794559|NCT00882440|OG006|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
10802988|NCT04010695|OG000|Outcome|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
10802989|NCT04010695|OG000|Outcome|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff performed the SD Biosensor POC G6PD test assay and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
10802990|NCT04010695|EG000|Reported Event|G6PD Diagnostic Testing|"Participants provided whole blood samples as well as finger-stick capillary blood samples.~At the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.~At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer."
10802991|NCT04003623|BG000|Baseline|Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements|Participants will receive 13.5mg QD Pemigatinib
10802992|NCT04003623|BG001|Baseline|Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3|Participants will receive 13.5mg QD Pemigatinib
10802993|NCT04003623|BG002|Baseline|Total|Total of all reporting groups
10802994|NCT04003623|FG000|Participant Flow|Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements|Participants will receive 13.5mg QD Pemigatinib
10802995|NCT04003623|FG001|Participant Flow|Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3|Participants will receive 13.5mg QD Pemigatinib
10802996|NCT04003623|OG000|Outcome|Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements|Participants will receive 13.5mg QD Pemigatinib
10802997|NCT04003623|OG001|Outcome|Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3|Participants will receive 13.5mg QD Pemigatinib
10802998|NCT04003623|EG000|Reported Event|Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements|Participants will receive 13.5mg QD Pemigatinib
10802999|NCT04003623|EG001|Reported Event|Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3|Participants will receive 13.5mg QD Pemigatinib
10803000|NCT03967847|BG000|Baseline|Control|Control: no ketorolac
10803001|NCT03967847|BG001|Baseline|Ketorolac|Ketorolac: Oral Ketorolac
10803002|NCT03967847|BG002|Baseline|Total|Total of all reporting groups
10803003|NCT03967847|FG000|Participant Flow|Control|Control: no ketorolac
10803004|NCT03967847|FG001|Participant Flow|Ketorolac|Ketorolac: Oral Ketorolac
11383513|NCT01997463|EG001|Reported Event|Supervised Therapy|"Supervised asthma therapy in schools~Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association"
11383514|NCT01943825|BG000|Baseline|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
11383515|NCT01943825|BG001|Baseline|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
11383516|NCT01943825|BG002|Baseline|CYD Dengue and JE Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
11383517|NCT01943825|BG003|Baseline|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383518|NCT01943825|BG004|Baseline|Total|Total of all reporting groups
11383519|NCT01943825|FG000|Participant Flow|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
11383520|NCT01943825|FG001|Participant Flow|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
11383521|NCT01943825|FG002|Participant Flow|CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
11383522|NCT01943825|FG003|Participant Flow|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383523|NCT01943825|OG000|Outcome|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
11383524|NCT01943825|OG001|Outcome|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
11383525|NCT01943825|OG002|Outcome|CYD Dengue and JE Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
11383526|NCT01943825|OG003|Outcome|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383527|NCT01943825|OG002|Outcome|CYD Dengue and JE Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccines at 0 and 1 months, respectively.
11383528|NCT01943825|OG000|Outcome|CYD Dengue and JE Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
11383529|NCT01943825|OG001|Outcome|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383530|NCT01943825|OG003|Outcome|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccines at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383531|NCT01943825|EG000|Reported Event|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
11383532|NCT01943825|EG001|Reported Event|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
11383533|NCT01943825|EG002|Reported Event|CYD Dengue and JE Vaccine : Group 3|Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
11383534|NCT01943825|EG003|Reported Event|CYD Dengue and JE Vaccine: Group 4|Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
11383535|NCT01940471|BG000|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383536|NCT01940471|BG001|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383537|NCT01940471|BG002|Baseline|Total|Total of all reporting groups
11383538|NCT01940471|FG000|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383539|NCT01940471|FG001|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383540|NCT01940471|OG000|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383541|NCT01940471|OG001|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks per amendment 1 & 2) or 144 weeks (per amendment 3)
11383542|NCT01940471|OG001|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383543|NCT01940471|EG000|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383544|NCT01940471|EG001|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
11383545|NCT01874353|BG000|Baseline|Olaparib 300mg Tablets|Taken orally twice daily
11383546|NCT01874353|BG001|Baseline|Placebo Tablets|Taken orally twice daily
11383547|NCT01874353|BG002|Baseline|Total|Total of all reporting groups
11383548|NCT01874353|FG000|Participant Flow|Olaparib 300mg Tablets (Global Cohort)|Taken orally twice daily
11383549|NCT01874353|FG001|Participant Flow|Placebo Tablets (Global Cohort)|Taken orally twice daily
11383550|NCT01874353|FG002|Participant Flow|Olaparib 300mg Tablets (China Cohort)|Taken orally twice daily
11383551|NCT01874353|FG003|Participant Flow|Placebo Tablets (China Cohort)|Taken orally twice daily
11383552|NCT01874353|OG000|Outcome|Olaparib 300mg Tablets (Global Cohort)|Taken orally twice daily
11383553|NCT01874353|OG001|Outcome|Placebo Tablets (Global Cohort)|Taken orally twice daily
11383554|NCT01874353|OG002|Outcome|Olaparib 300mg Tablets (China Cohort)|Taken orally twice daily
11383555|NCT01874353|OG003|Outcome|Placebo Tablets (China Cohort)|Taken orally twice daily
10794560|NCT00872430|BG000|Baseline|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
10794561|NCT00872430|BG001|Baseline|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
10794562|NCT00872430|BG002|Baseline|Total|Total of all reporting groups
10794563|NCT00872430|FG000|Participant Flow|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
10794564|NCT00872430|FG001|Participant Flow|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
10794565|NCT00872430|OG000|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
10794566|NCT00872430|OG001|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
10794567|NCT00870688|BG000|Baseline|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
10794568|NCT00870688|FG000|Participant Flow|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
10794569|NCT00870688|OG000|Outcome|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
10794570|NCT00869128|BG000|Baseline|Entire Study Population|Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
10794571|NCT00869128|FG000|Participant Flow|Placebo First|Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
10794572|NCT00869128|FG001|Participant Flow|Circadin First|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
10794573|NCT00869128|OG000|Outcome|Placebo|Subjects were treated for 3 weeks with 1 tablet per night of Placebo
11383556|NCT01874353|OG002|Outcome|Olaparib 300mg Tablets (ChinaCohort)|Taken orally twice daily
11383557|NCT01874353|OG000|Outcome|Olaparib 300mg Tablets|Taken orally twice daily
11383558|NCT01874353|EG000|Reported Event|Olaparib 300 Tablets (Global Cohort)|Taken orally twice daily
11383559|NCT01874353|EG001|Reported Event|Placebo Tablets (Global Cohort)|Taken orally twice daily
11383560|NCT01874353|EG002|Reported Event|Olaparib 300 Tablets (China Cohort)|Taken orally twice daily
11383561|NCT01874353|EG003|Reported Event|Placebo Tablets (China Cohort)|Taken orally twice daily
11383562|NCT01863186|BG000|Baseline|DB: Lofexidine HCl 2.4mg Dose|Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
11383563|NCT01863186|BG001|Baseline|DB: Lofexidine HCl 3.2mg Dose|Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
10794574|NCT00869128|OG001|Outcome|Circadin|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
10794575|NCT00861705|BG000|Baseline|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
10794576|NCT00861705|BG001|Baseline|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10794577|NCT00861705|BG002|Baseline|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
10794578|NCT00861705|BG003|Baseline|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
10794579|NCT00861705|BG004|Baseline|Total|Total of all reporting groups
10794580|NCT00861705|FG000|Participant Flow|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
10794581|NCT00861705|FG001|Participant Flow|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10794582|NCT00861705|FG002|Participant Flow|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
10794583|NCT00861705|FG003|Participant Flow|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
10794584|NCT00861705|OG000|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
10794585|NCT00861705|OG001|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
10803005|NCT03967847|OG000|Outcome|Control|No ketorolac
10803006|NCT03967847|OG001|Outcome|Ketorolac|Ketorolac: Oral Ketorolac
10794586|NCT00861705|OG000|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
10794587|NCT00861705|OG001|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
10794588|NCT00861705|OG000|Outcome|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV"
10794589|NCT00861705|OG001|Outcome|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV"
10794590|NCT00861705|OG002|Outcome|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV"
10794591|NCT00861705|OG003|Outcome|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV"
10794592|NCT00861705|OG000|Outcome|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
10794593|NCT00861705|OG001|Outcome|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
10794594|NCT00861705|OG002|Outcome|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
10794595|NCT00861705|OG003|Outcome|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
10794596|NCT00861705|EG000|Reported Event|Arm 1 (Pac --> ddAC)|cyclophosphamide: Given IV
10794597|NCT00861705|EG001|Reported Event|Arm 2 (Pac + Bev --> ddAC + Bev)|bevacizumab: Given IV
10794598|NCT00861705|EG002|Reported Event|Arm 3 (Pac + Carboplatin --> ddAC)|carboplatin: Given IV
10794599|NCT00861705|EG003|Reported Event|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|carboplatin: Given IV
10794600|NCT00859521|BG000|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
10794601|NCT00859521|BG001|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
10794602|NCT00859521|BG002|Baseline|Total|Total of all reporting groups
10794603|NCT00859521|FG000|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
10794604|NCT00859521|FG001|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
10794605|NCT00859521|OG000|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
10794606|NCT00859521|OG001|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
10794607|NCT00859430|BG000|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
10794608|NCT00859430|BG001|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
10794609|NCT00859430|BG002|Baseline|Total|Total of all reporting groups
10794610|NCT00859430|FG000|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
10794611|NCT00859430|FG001|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
10794612|NCT00859430|OG000|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
10794613|NCT00859430|OG001|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
10794614|NCT00858702|BG000|Baseline|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
10794615|NCT00858702|BG001|Baseline|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
10794616|NCT00858702|BG002|Baseline|Total|Total of all reporting groups
10794617|NCT00858702|FG000|Participant Flow|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
10794618|NCT00858702|FG001|Participant Flow|Olmesartan Medoxomil Tablets and a Diuretic Tablet|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
10794619|NCT00858702|OG000|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
10794620|NCT00858702|OG001|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
10794621|NCT00858702|OG000|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
10794622|NCT00858702|OG001|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
10794623|NCT00857285|BG000|Baseline|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
10794624|NCT00857285|BG001|Baseline|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
10794625|NCT00857285|BG002|Baseline|Total|Total of all reporting groups
10794626|NCT00857285|FG000|Participant Flow|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
10794627|NCT00857285|FG001|Participant Flow|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
10794628|NCT00857285|OG000|Outcome|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
10794629|NCT00857285|OG001|Outcome|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
11195901|NCT02161458|FG003|Participant Flow|Escitalopram 20mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195902|NCT02161458|OG000|Outcome|Escitalopram 20mg for 2 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 2 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
10794630|NCT00856934|BG000|Baseline|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
10794631|NCT00856934|BG001|Baseline|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794632|NCT00856934|BG002|Baseline|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794633|NCT00856934|BG003|Baseline|Total|Total of all reporting groups
10794634|NCT00856934|FG000|Participant Flow|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
10794635|NCT00856934|FG001|Participant Flow|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794636|NCT00856934|FG002|Participant Flow|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794637|NCT00856934|OG000|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
10794638|NCT00856934|OG001|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794639|NCT00856934|OG002|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
10794640|NCT00850174|BG000|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
10794641|NCT00850174|BG001|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
10794642|NCT00850174|BG002|Baseline|Total|Total of all reporting groups
10794643|NCT00850174|FG000|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
10794644|NCT00850174|FG001|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
10794645|NCT00850174|OG000|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
10794646|NCT00850174|OG001|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
10794647|NCT00849862|BG000|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
10794648|NCT00849862|BG001|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
10794649|NCT00849862|BG002|Baseline|Total|Total of all reporting groups
10794650|NCT00849862|FG000|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
10794651|NCT00849862|FG001|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
10794652|NCT00849862|OG000|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
10794653|NCT00849862|OG001|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
10794654|NCT00849797|BG000|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
10794655|NCT00849797|BG001|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
10794656|NCT00849797|BG002|Baseline|Total|Total of all reporting groups
10794657|NCT00849797|FG000|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
10803007|NCT03967847|OG000|Outcome|Control|Control: no ketorolac
10794658|NCT00849797|FG001|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
10794659|NCT00849797|OG000|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
10794660|NCT00849797|OG001|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
10794661|NCT00849797|OG001|Outcome|Trileptal|Trileptal® 600 mg Tablet (reference) dosed in either period
10794662|NCT00849485|BG000|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
10794663|NCT00849485|BG001|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
10794664|NCT00849485|BG002|Baseline|Total|Total of all reporting groups
11202243|NCT02206607|OG002|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794665|NCT00849485|FG000|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
10794666|NCT00849485|FG001|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
10794667|NCT00849485|OG000|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
10794668|NCT00849485|OG001|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
10794669|NCT00847405|BG000|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
10794670|NCT00847405|BG001|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
10794671|NCT00847405|BG002|Baseline|Total|Total of all reporting groups
10794672|NCT00847405|FG000|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
10794673|NCT00847405|FG001|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
10794674|NCT00847405|OG000|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
10794675|NCT00847405|OG001|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
10794676|NCT00846885|BG000|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
10794677|NCT00846885|BG001|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
10794678|NCT00846885|BG002|Baseline|Total|Total of all reporting groups
10794679|NCT00846885|FG000|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
10794680|NCT00846885|FG001|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
10794681|NCT00846885|OG000|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
10794682|NCT00846885|OG001|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
10794683|NCT00841815|BG000|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
10794684|NCT00841815|BG001|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
10794685|NCT00841815|BG002|Baseline|Total|Total of all reporting groups
10794686|NCT00841815|FG000|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
10794687|NCT00841815|FG001|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
10794688|NCT00841815|OG000|Outcome|Amlodipine Besylate|Amlodipine Besylate 10 mg tablet (test) dosed in either period
10794689|NCT00841815|OG001|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
10794690|NCT00841815|OG000|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
10794691|NCT00841698|BG000|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
10794692|NCT00841698|BG001|Baseline|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
10794693|NCT00841698|BG002|Baseline|Total|Total of all reporting groups
10794694|NCT00841698|FG000|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
10794695|NCT00841698|FG001|Participant Flow|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
10794696|NCT00841698|OG000|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
10794697|NCT00841698|OG001|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
10794698|NCT00841659|BG000|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
10803008|NCT03967847|EG000|Reported Event|Control|No ketorolac
10803009|NCT03967847|EG001|Reported Event|Ketorolac|Ketorolac: Oral Ketorolac
10794699|NCT00841659|BG001|Baseline|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
10794700|NCT00841659|BG002|Baseline|Total|Total of all reporting groups
10794701|NCT00841659|FG000|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
10794702|NCT00841659|FG001|Participant Flow|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
10794703|NCT00841659|OG000|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
10794704|NCT00841659|OG001|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
10794705|NCT00841542|BG000|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
10794706|NCT00841542|BG001|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
10794707|NCT00841542|BG002|Baseline|Total|Total of all reporting groups
10794708|NCT00841542|FG000|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
10794709|NCT00841542|FG001|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
10794710|NCT00841542|OG000|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
10794711|NCT00841542|OG001|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
10794712|NCT00840879|BG000|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
10794713|NCT00840879|BG001|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
10794714|NCT00840879|BG002|Baseline|Total|Total of all reporting groups
10794715|NCT00840879|FG000|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
10794716|NCT00840879|FG001|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
10794717|NCT00840879|OG000|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
10794718|NCT00840879|OG001|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
10794719|NCT00840866|BG000|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
10794720|NCT00840866|BG001|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
10794721|NCT00840866|BG002|Baseline|Total|Total of all reporting groups
10794722|NCT00840866|FG000|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
10794723|NCT00840866|FG001|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
10794724|NCT00840866|OG000|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
10794725|NCT00840866|OG001|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
10794726|NCT00840840|BG000|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
10794727|NCT00840840|BG001|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
10794728|NCT00840840|BG002|Baseline|Total|Total of all reporting groups
10794729|NCT00840840|FG000|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
10794730|NCT00840840|FG001|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
10794731|NCT00840840|OG000|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
10794732|NCT00840840|OG001|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
10794733|NCT00840632|BG000|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
10794734|NCT00840632|BG001|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
10794735|NCT00840632|BG002|Baseline|Total|Total of all reporting groups
10794736|NCT00840632|FG000|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
10794737|NCT00840632|FG001|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
10794738|NCT00840632|OG000|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
10794739|NCT00840632|OG001|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
10794740|NCT00840476|BG000|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
10794741|NCT00840476|BG001|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
11202244|NCT02206607|OG003|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794742|NCT00840476|BG002|Baseline|Total|Total of all reporting groups
10794743|NCT00840476|FG000|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
10794744|NCT00840476|FG001|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
10794745|NCT00840476|OG000|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
10794746|NCT00840476|OG001|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
10794747|NCT00840411|BG000|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
10794748|NCT00840411|BG001|Baseline|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
10794749|NCT00840411|BG002|Baseline|Total|Total of all reporting groups
10794750|NCT00840411|FG000|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
10794751|NCT00840411|FG001|Participant Flow|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
10794752|NCT00840411|OG000|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
10794753|NCT00840411|OG001|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
10794754|NCT00840281|BG000|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
10794755|NCT00840281|BG001|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
10794756|NCT00840281|BG002|Baseline|Total|Total of all reporting groups
10794757|NCT00840281|FG000|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
10794758|NCT00840281|FG001|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
10794759|NCT00840281|OG000|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
10794760|NCT00840281|OG001|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
10794761|NCT00840216|BG000|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
10794762|NCT00840216|BG001|Baseline|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
10794763|NCT00840216|BG002|Baseline|Total|Total of all reporting groups
10794764|NCT00840216|FG000|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
10794765|NCT00840216|FG001|Participant Flow|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
10794766|NCT00840216|OG000|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
10794767|NCT00840216|OG001|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
10794768|NCT00840203|BG000|Baseline|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
10794769|NCT00840203|BG001|Baseline|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
10794770|NCT00840203|BG002|Baseline|Total|Total of all reporting groups
10794771|NCT00840203|FG000|Participant Flow|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
10794772|NCT00840203|FG001|Participant Flow|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
10794773|NCT00840203|OG000|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
10794774|NCT00840203|OG001|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
10794775|NCT00840099|BG000|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
10794776|NCT00840099|BG001|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
10794777|NCT00840099|BG002|Baseline|Total|Total of all reporting groups
10794778|NCT00840099|FG000|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
10794779|NCT00840099|FG001|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
10794780|NCT00840099|OG000|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
10794781|NCT00840099|OG001|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
10794782|NCT00840073|BG000|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
10794783|NCT00840073|BG001|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
10794784|NCT00840073|BG002|Baseline|Total|Total of all reporting groups
10794785|NCT00840073|FG000|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
10794786|NCT00840073|FG001|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
10794787|NCT00840073|OG000|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
10794788|NCT00840073|OG001|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
10794789|NCT00839930|BG000|Baseline|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
10794790|NCT00839930|BG001|Baseline|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
10794791|NCT00839930|BG002|Baseline|Total|Total of all reporting groups
10794792|NCT00839930|FG000|Participant Flow|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
10794793|NCT00839930|FG001|Participant Flow|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
10794794|NCT00839930|OG000|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
10794795|NCT00839930|OG001|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
10794796|NCT00838630|BG000|Baseline|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
10794797|NCT00838630|BG001|Baseline|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
10794798|NCT00838630|BG002|Baseline|Total|Total of all reporting groups
10794799|NCT00838630|FG000|Participant Flow|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
10794800|NCT00838630|FG001|Participant Flow|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
10794801|NCT00838630|OG000|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
10794802|NCT00838630|OG001|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
10794803|NCT00838279|BG000|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
10794804|NCT00838279|BG001|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
10794805|NCT00838279|BG002|Baseline|Total|Total of all reporting groups
10794806|NCT00838279|FG000|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
10794807|NCT00838279|FG001|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
10794808|NCT00838279|OG000|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
10794809|NCT00838279|OG001|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
10794810|NCT00838136|BG000|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
10794811|NCT00838136|BG001|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
10794812|NCT00838136|BG002|Baseline|Total|Total of all reporting groups
10794813|NCT00838136|FG000|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
10794814|NCT00838136|FG001|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
10794815|NCT00838136|OG000|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
10794816|NCT00838136|OG001|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
10794817|NCT00836901|BG000|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
10794818|NCT00836901|BG001|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
10794819|NCT00836901|BG002|Baseline|Total|Total of all reporting groups
10794820|NCT00836901|FG000|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
10794821|NCT00836901|FG001|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
10794822|NCT00836901|OG000|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
10794823|NCT00836901|OG001|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
10794824|NCT00836706|BG000|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
10794825|NCT00836706|BG001|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
10794826|NCT00836706|BG002|Baseline|Total|Total of all reporting groups
10794827|NCT00836706|FG000|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
10794828|NCT00836706|FG001|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
10794829|NCT00836706|OG000|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
10794830|NCT00836706|OG001|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
10794831|NCT00836472|BG000|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
10794832|NCT00836472|BG001|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
11195903|NCT02161458|OG001|Outcome|Placebo (Sugar Pill)|"30 cognitively normal adults aged 60-85 will receive placebo for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days) or 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 or 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Placebo: Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration."
11202245|NCT02206607|OG004|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
11241207|NCT02485483|BG001|Baseline|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
10794833|NCT00836472|BG002|Baseline|Total|Total of all reporting groups
10794834|NCT00836472|FG000|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
10794835|NCT00836472|FG001|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
10794836|NCT00836472|OG000|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
10794837|NCT00836472|OG001|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
10803010|NCT03828383|BG000|Baseline|In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display."
10803011|NCT03828383|BG001|Baseline|Limited In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur."
10803012|NCT03828383|BG002|Baseline|Total|Total of all reporting groups
10803013|NCT03828383|FG000|Participant Flow|In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display."
10803014|NCT03828383|FG001|Participant Flow|Limited In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur."
10794838|NCT00836056|BG000|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
10794839|NCT00836056|BG001|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
10794840|NCT00836056|BG002|Baseline|Total|Total of all reporting groups
10794841|NCT00836056|FG000|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
10794842|NCT00836056|FG001|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
10794843|NCT00836056|OG000|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
10794844|NCT00836056|OG001|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
10794845|NCT00836004|BG000|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
10794846|NCT00836004|BG001|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
10794847|NCT00836004|BG002|Baseline|Total|Total of all reporting groups
10794848|NCT00836004|FG000|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
10794849|NCT00836004|FG001|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
10794850|NCT00836004|OG000|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
10794851|NCT00836004|OG001|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
10794852|NCT00835991|BG000|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
10794853|NCT00835991|BG001|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
10794854|NCT00835991|BG002|Baseline|Total|Total of all reporting groups
10794855|NCT00835991|FG000|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
10794856|NCT00835991|FG001|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
10794857|NCT00835991|OG000|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
10794858|NCT00835991|OG001|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
11241208|NCT02485483|BG002|Baseline|Total|Total of all reporting groups
10794859|NCT00835796|BG000|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
10794860|NCT00835796|BG001|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
10794861|NCT00835796|BG002|Baseline|Total|Total of all reporting groups
10794862|NCT00835796|FG000|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
10794863|NCT00835796|FG001|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
10794864|NCT00835796|OG000|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
10794865|NCT00835796|OG001|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
10794866|NCT00835705|BG000|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
10794867|NCT00835705|BG001|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
10794868|NCT00835705|BG002|Baseline|Total|Total of all reporting groups
10794869|NCT00835705|FG000|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
10794870|NCT00835705|FG001|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
10794871|NCT00835705|OG000|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
10794872|NCT00835705|OG001|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
10794873|NCT00835692|BG000|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
10794874|NCT00835692|BG001|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
10794875|NCT00835692|BG002|Baseline|Total|Total of all reporting groups
10794876|NCT00835692|FG000|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
10794877|NCT00835692|FG001|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
10794878|NCT00835692|OG000|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
10794879|NCT00835692|OG001|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
10794880|NCT00835666|BG000|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
10794881|NCT00835666|BG001|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
11383564|NCT01863186|BG002|Baseline|DB: Placebo|"Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.~Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo."
11383565|NCT01863186|BG003|Baseline|Total|Total of all reporting groups
11383566|NCT01863186|FG000|Participant Flow|DB: Lofexidine HCl 2.4mg Dose|Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
11383567|NCT01863186|FG001|Participant Flow|DB: Lofexidine HCl 3.2mg Dose|Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
11383568|NCT01863186|FG002|Participant Flow|DB: Placebo|"Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.~Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo."
11383569|NCT01863186|FG003|Participant Flow|OL: All Lofexidine HCl|Participants were given the option to receive lofexidine HCl tablets for up to 7 additional days, following the double blind period. Dosing regimens are at the discretion of the Investigator, but total daily dose will not exceed 3.2 mg.
11383570|NCT01863186|OG000|Outcome|DB: Lofexidine HCl 2.4mg Dose|Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
11383571|NCT01863186|OG001|Outcome|DB: Lofexidine HCl 3.2mg Dose|Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
11383572|NCT01863186|OG002|Outcome|DB: Placebo|"Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.~Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo."
11383573|NCT01863186|EG000|Reported Event|DB: Lofexidine HCl 2.4mg Dose|Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
11383574|NCT01863186|EG001|Reported Event|DB: Lofexidine HCl 3.2mg Dose|Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
11383575|NCT01863186|EG002|Reported Event|DB: Placebo|"Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.~Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo."
11383576|NCT01863186|EG003|Reported Event|OL: All Lofexidine HCl|Participants were given the option to receive lofexidine HCl tablets for up to 7 additional days, following the double blind period. Dosing regimens are at the discretion of the Investigator, but total daily dose will not exceed 3.2 mg.
11383577|NCT01853748|BG000|Baseline|Trastuzumab Emtansine (T-DM1)|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383578|NCT01853748|BG001|Baseline|Paclitaxel + Trastuzumab (TH)|paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
11383579|NCT01853748|BG002|Baseline|Total|Total of all reporting groups
11383580|NCT01853748|FG000|Participant Flow|Trastuzumab Emtansine (T-DM1)|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383581|NCT01853748|FG001|Participant Flow|Paclitaxel + Trastuzumab (TH)|paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
11383582|NCT01853748|OG000|Outcome|Trastuzumab Emtansine (T-DM1)|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383583|NCT01853748|OG001|Outcome|Paclitaxel + Trastuzumab|paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
11383584|NCT01853748|OG001|Outcome|Paclitaxel + Trastuzumab (TH)|paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
11383585|NCT01853748|OG000|Outcome|T-DM1 With no Baseline Neuropathy|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. No neuropathy at baseline
11383586|NCT01853748|OG001|Outcome|TH With no Baseline Neuropathy|"paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments.~No neuropathy at baseline"
11383587|NCT01853748|OG002|Outcome|T-DM1 With Any Baseline Neuropathy|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. Neuropathy at baseline
11383588|NCT01853748|OG003|Outcome|TH With Any Baseline Neuropathy|"paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments.~Neuropathy at baseline"
11383589|NCT01853748|OG000|Outcome|Trastuzumab Emtansine (T-DM1)|"T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks~Trastuzumab emtansine"
10794882|NCT00835666|BG002|Baseline|Total|Total of all reporting groups
11383590|NCT01853748|OG001|Outcome|Paclitaxel + Trastuzumab|"paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments~Trastuzumab~Paclitaxel"
11383591|NCT01853748|OG000|Outcome|Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383592|NCT01853748|OG001|Outcome|Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383593|NCT01853748|EG000|Reported Event|Trastuzumab Emtansine (T-DM1)|T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
11383594|NCT01853748|EG001|Reported Event|Paclitaxel + Trastuzumab|paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
11383595|NCT01817751|BG000|Baseline|Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)|"Sorafenib 400 mg orally twice a day;~Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;~Sildenafil 50 mg orally twice a day~A cycle consists of 4 weeks.~*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)~sorafenib tosylate: Given by mouth~valproic acid: Given by mouth~sildenafil citrate: Given by mouth"
11383596|NCT01817751|FG000|Participant Flow|Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)|"Sorafenib 400 mg orally twice a day;~Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;~Sildenafil 50 mg orally twice a day~A cycle consists of 4 weeks.~*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)~sorafenib tosylate: Given by mouth~valproic acid: Given by mouth~sildenafil citrate: Given by mouth"
11383597|NCT01817751|OG000|Outcome|Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)|"Sorafenib 400 mg orally twice a day;~Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;~Sildenafil 50 mg orally twice a day~A cycle consists of 4 weeks.~*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)~sorafenib tosylate: Given by mouth~valproic acid: Given by mouth~sildenafil citrate: Given by mouth"
11383598|NCT01817751|EG000|Reported Event|Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)|"Sorafenib 400 mg orally twice a day;~Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;~Sildenafil 50 mg orally twice a day~A cycle consists of 4 weeks.~*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)~sorafenib tosylate: Given by mouth~valproic acid: Given by mouth~sildenafil citrate: Given by mouth"
11383599|NCT01722331|BG000|Baseline|Tildrakizumab 200 mg (Part 1)|Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
11383600|NCT01722331|BG001|Baseline|Tildrakizumab 100 mg (Part 1)|Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
11383601|NCT01722331|BG002|Baseline|Placebo (Part 1)|Matching placebo administered SC once a week at Weeks 0 and 4.
11383602|NCT01722331|BG003|Baseline|Total|Total of all reporting groups
11383603|NCT01722331|FG000|Participant Flow|Tildrakizumab 200 mg (Parts 1, 2 & 3)|Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
11383604|NCT01722331|FG001|Participant Flow|Tildrakizumab 100 mg (Parts 1, 2 & 3)|Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
11383605|NCT01722331|FG002|Participant Flow|Tildrakizumab 100 mg (Parts 1 & 2)|Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2).
11383606|NCT01722331|FG003|Participant Flow|Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)|Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3).
11383607|NCT01722331|FG004|Participant Flow|Placebo (Part 1)|Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1).
11383608|NCT01722331|FG005|Participant Flow|Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)|Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
11383609|NCT01722331|FG006|Participant Flow|Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)|Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
11383610|NCT01722331|OG000|Outcome|Tildrakizumab 200 mg (Part 1)|Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
11383611|NCT01722331|OG001|Outcome|Tildrakizumab 100 mg (Part 1)|Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
11383612|NCT01722331|OG002|Outcome|Placebo (Part 1)|Matching placebo administered SC once a week at Weeks 0 and 4.
11383613|NCT01722331|EG000|Reported Event|Tildrakizumab 200 mg (Part 1)|Tildrakizumab 200 mg administered once a week at Weeks 0 and 4.
11383614|NCT01722331|EG001|Reported Event|Tildrakizumab 100 mg (Part 1)|Tildrakizumab 100 mg administered once a week at Weeks 0 and 4.
11383615|NCT01722331|EG002|Reported Event|Placebo (Part 1)|Placebo administered once a week at Weeks 0 and 4.
11383616|NCT01722331|EG003|Reported Event|Tildrakizumab 200 mg (Part 2)|Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg).
11383617|NCT01722331|EG004|Reported Event|Tildrakizumab 100 mg (Part 2)|Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12.
11195904|NCT02161458|OG002|Outcome|Escitalopram 30mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 5 days; then 30 mg for 46 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 30mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195905|NCT02161458|OG003|Outcome|Escitalopram 20mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195906|NCT02161458|EG000|Reported Event|Escitalopram 20mg for 2 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 2 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195907|NCT02161458|EG001|Reported Event|Placebo (Sugar Pill)|"30 cognitively normal adults aged 60-85 will receive placebo for 2 weeks (upward titration as: 10mg for 5 days, then 20mg for 9 days) or 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 2 or 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Placebo: Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration."
11195908|NCT02161458|EG002|Reported Event|Escitalopram 30mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 5 days; then 30 mg for 46 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 30mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195909|NCT02161458|EG003|Reported Event|Escitalopram 20mg for 8 Weeks|"30 cognitively normal adults aged 60-85 will receive escitalopram 20mg for 8 weeks (upward titration as: 10mg for 5 days, then 20mg for 51 days); and amyloid beta levels in the CSF will be measured at baseline (before drug administration) and after 8 weeks of study drug (active or placebo). Participants will taper off medication following the 2nd CSF measurement.~Escitalopram 20mg for 8 weeks: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration."
11195910|NCT02161484|BG000|Baseline|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
11202246|NCT02206607|EG000|Reported Event|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
10794883|NCT00835666|FG000|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
10794884|NCT00835666|FG001|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
11202247|NCT02206607|EG001|Reported Event|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
10794885|NCT00835666|OG000|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
10794886|NCT00835666|OG001|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
10794887|NCT00835640|BG000|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
10794888|NCT00835640|BG001|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
10794889|NCT00835640|BG002|Baseline|Total|Total of all reporting groups
10794890|NCT00835640|FG000|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
10794891|NCT00835640|FG001|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
10794892|NCT00835640|OG000|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
10794893|NCT00835640|OG001|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
10794894|NCT00835614|BG000|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
10794895|NCT00835614|BG001|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
10794896|NCT00835614|BG002|Baseline|Total|Total of all reporting groups
10794897|NCT00835614|FG000|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
11195911|NCT02161484|BG001|Baseline|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
11195912|NCT02161484|BG002|Baseline|Total|Total of all reporting groups
11195913|NCT02161484|FG000|Participant Flow|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
11195914|NCT02161484|FG001|Participant Flow|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
11195915|NCT02161484|OG000|Outcome|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
11195916|NCT02161484|OG001|Outcome|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
10794898|NCT00835614|FG001|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
10794899|NCT00835614|OG000|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
10794900|NCT00835614|OG001|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
10794901|NCT00835588|BG000|Baseline|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
10794902|NCT00835588|BG001|Baseline|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
10794903|NCT00835588|BG002|Baseline|Total|Total of all reporting groups
10794904|NCT00835588|FG000|Participant Flow|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
10794905|NCT00835588|FG001|Participant Flow|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
10794906|NCT00835588|OG000|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
10794907|NCT00835588|OG001|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
10794908|NCT00835575|BG000|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
10794909|NCT00835575|BG001|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
10794910|NCT00835575|BG002|Baseline|Total|Total of all reporting groups
10794911|NCT00835575|FG000|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
11195917|NCT02161484|EG000|Reported Event|Continuous Lumbar Plexus Block With Parasacral Nerve Block|"Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected."
11195918|NCT02161484|EG001|Reported Event|Lumbar Plexus Nerve Block|"Arm: Active Comparator: Lumbar Plexus Nerve Block~Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.~No sham/placebo parasacral (sciatic) blocks will be performed in this group."
11195919|NCT02161536|BG000|Baseline|Motus CleanC System Rev 2.0|Motus CleanC System Rev 2.0
11195920|NCT02161536|BG001|Baseline|Motus Cleansing System Rev 2.5|Motus Cleansing System Rev 2.5
11195921|NCT02161536|BG002|Baseline|Motus Cleansing System Rev 3.0|Motus Cleansing System Rev 3.0
11195922|NCT02161536|BG003|Baseline|Total|Total of all reporting groups
11195923|NCT02161536|FG000|Participant Flow|Motus CleanC Syetem Rev 2.0|6 subjects used the second version of the device
11195924|NCT02161536|FG001|Participant Flow|Motus Cleansing System Rev 2.5|21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5
11195925|NCT02161536|FG002|Participant Flow|Motus Cleansing System Rev 3.0|20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0
11195926|NCT02161536|OG000|Outcome|Motus CleanC System|"Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0~Motus Cleansing System"
11195927|NCT02161536|OG001|Outcome|Motus Cleansing System Rev 2.5|"Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0~Motus Cleansing System"
11195928|NCT02161536|OG002|Outcome|Motus Cleansing System Rev 3.0|"Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0~Motus Cleansing System"
11195929|NCT02161536|EG000|Reported Event|Motus CleanC Syetem Rev 2.0|6 subjects used the second version of the device
11195930|NCT02161536|EG001|Reported Event|Motus Cleansing System Rev 2.5|21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5
11195931|NCT02161536|EG002|Reported Event|Motus Cleansing System Rev 3.0|20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0
11195932|NCT02161549|BG000|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
11195933|NCT02161549|BG001|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
11195934|NCT02161549|BG002|Baseline|Total|Total of all reporting groups
11195935|NCT02161549|FG000|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
11195936|NCT02161549|FG001|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
11195937|NCT02161549|OG000|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
11195938|NCT02161549|OG001|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
11195939|NCT02161549|EG000|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
11195940|NCT02161549|EG001|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
11195941|NCT02161562|BG000|Baseline|Omalizumab 150mg (A)|Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.
11195942|NCT02161562|BG001|Baseline|Omalizumab 300mg (B)|Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
11195943|NCT02161562|BG002|Baseline|Total|Total of all reporting groups
11195944|NCT02161562|FG000|Participant Flow|Omalizumab 150mg (A)|Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.
11195945|NCT02161562|FG001|Participant Flow|Omalizumab 300mg (B)|Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
11195946|NCT02161562|OG000|Outcome|All Retreatment (A2&B2)|omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group
11195947|NCT02161562|OG001|Outcome|Retreatment (A2)|omalizumab 150 mg retreatment group
11195948|NCT02161562|OG002|Outcome|Retreatment (B2)|omalizumab 300 mg retreatment
11195949|NCT02161562|OG000|Outcome|Step-up Treatment Group (A3)|Step-up treatment from omalizumab 150 mg to 300 mg
11383618|NCT01722331|EG005|Reported Event|Tildrakizumab 200 mg (Part 3)|Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
11195950|NCT02161562|OG000|Outcome|Extended Treatment (B3)|omalizumab 300 mg extended treatment
11195951|NCT02161562|OG000|Outcome|Omalizumab 300mg (B)|Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
11195952|NCT02161562|OG000|Outcome|Omalizumab 150mg (A)|Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.
10794912|NCT00835575|FG001|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
10794913|NCT00835575|OG000|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
10794914|NCT00835575|OG001|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
10794915|NCT00835549|BG000|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
10794916|NCT00835549|BG001|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
10794917|NCT00835549|BG002|Baseline|Total|Total of all reporting groups
10794918|NCT00835549|FG000|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
10794919|NCT00835549|FG001|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
10794920|NCT00835549|OG000|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
10794921|NCT00835549|OG001|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
10794922|NCT00835536|BG000|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
10794923|NCT00835536|BG001|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
10794924|NCT00835536|BG002|Baseline|Total|Total of all reporting groups
10794925|NCT00835536|FG000|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
10794926|NCT00835536|FG001|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
10794927|NCT00835536|OG000|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
10794928|NCT00835536|OG001|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
10794929|NCT00835497|BG000|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
10794930|NCT00835497|BG001|Baseline|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
10794931|NCT00835497|BG002|Baseline|Total|Total of all reporting groups
11195953|NCT02161562|OG001|Outcome|Omalizumab 300mg (B)|Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
11195954|NCT02161562|OG002|Outcome|Overall (A&B)|
11195955|NCT02161562|EG000|Reported Event|Omalizumab 150 mg (A)|Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.
10794932|NCT00835497|FG000|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
10794933|NCT00835497|FG001|Participant Flow|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
10794934|NCT00835497|OG000|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
10794935|NCT00835497|OG001|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
10794936|NCT00835484|BG000|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
10794937|NCT00835484|BG001|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
10794938|NCT00835484|BG002|Baseline|Total|Total of all reporting groups
10794939|NCT00835484|FG000|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
10794940|NCT00835484|FG001|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
10794941|NCT00835484|OG000|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
10794942|NCT00835484|OG001|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
11195956|NCT02161562|EG001|Reported Event|Maintained Response (A1)|omalizumab 150 mg maintained response group
11195957|NCT02161562|EG002|Reported Event|Retreatment (A2)|omalizumab 150 mg retreatment group
11195958|NCT02161562|EG003|Reported Event|Step-up Treatment Group (A3)|Step-up treatment from omalizumab 150 mg to 300 mg
11195959|NCT02161562|EG004|Reported Event|Omalizumab 300 mg (B)|Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
11195960|NCT02161562|EG005|Reported Event|Maintained Response(B1)|omalizumab 300 mg Maintained Response group
11195961|NCT02161562|EG006|Reported Event|Retreatment (B2)|omalizumab 300 mg retreatment
11195962|NCT02161562|EG007|Reported Event|Extended Treatment (B3)|omalizumab 300 mg extended treatment
11195963|NCT02161575|BG000|Baseline|Ranibizumab|All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
11383619|NCT01722331|EG006|Reported Event|Tildrakizumab 100 mg (Part 3)|Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
11383620|NCT01716117|BG000|Baseline|Surpass Flow Diverter (mITT)|The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.
11383621|NCT01716117|BG001|Baseline|Roll-In|"An additional 45 Roll-In subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 Roll-In and Enrolled but Not Treated subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes."
11383622|NCT01716117|BG002|Baseline|Total|Total of all reporting groups
11383623|NCT01716117|FG000|Participant Flow|Surpass Flow Diverter (mITT Population)|The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.
11383624|NCT01716117|FG001|Participant Flow|Surpass Flow Diverter (Roll-In Population)|"An additional 45 Roll-In subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 Roll-In and Enrolled but Not Treated subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes."
11383625|NCT01716117|OG000|Outcome|Surpass Flow Diverter (mITT Population)|The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.
11383626|NCT01716117|OG000|Outcome|Surpass Flow Diverter (mITT)|The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.
11383627|NCT01716117|OG000|Outcome|Device Not Fully Apposed to Vessel Wall at 12 Months|Subgroups of patients who did not have full apposition of the device to the vessel wall.
11383628|NCT01716117|OG001|Outcome|Device Fully Apposed to Vessel Wall at 12 Months|Subgroups of patients who had full apposition of the device to the vessel wall.
11383629|NCT01716117|OG001|Outcome|Surpass Flow Diverter (Roll-In Population)|"An additional 45 Roll-In subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 Roll-In and Enrolled but Not Treated subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes."
11383630|NCT01716117|OG000|Outcome|Under Age 65|Subjects below 65 years of age
11383631|NCT01716117|OG001|Outcome|Age 65 and Older|Subjects of at least 65 years of age
11383632|NCT01716117|OG000|Outcome|All Intracranial Aneurysm Sizes Except Giant|Intracranial aneurysms not considered giant
11383633|NCT01716117|OG001|Outcome|Giant Intracranial Aneurysms|Intracranial aneurysms considered giant
11383634|NCT01716117|OG001|Outcome|Roll-In|"An additional 45 Roll-In subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 Roll-In and Enrolled but Not Treated subjects."
11383635|NCT01716117|EG000|Reported Event|Surpass Flow Diverter (mITT Population)|The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.
11383636|NCT01716117|EG001|Reported Event|Surpass Flow Diverter (Roll-in Population)|The Roll-in population was defined in the clinical protocol as all subjects who were enrolled as training cases and not considered part of the mITT population, and in whom the Surpass™ Flow Diverter entered the body regardless of whether or not the device was successfully implanted.
11383637|NCT01698905|BG000|Baseline|NTCS Phase|Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
11383638|NCT01698905|FG000|Participant Flow|NTCS Phase|Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
11383639|NCT01698905|OG000|Outcome|NTCS Phase|Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
11383640|NCT01698905|EG000|Reported Event|NTCS Phase|Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
11383641|NCT01698905|EG001|Reported Event|TFR Phase|treatment-free remission
11383642|NCT01698905|EG002|Reported Event|NTRI Phase|nilotinib treatment re-initiation
11383643|NCT01698905|EG003|Reported Event|NTCT Phase|nilotinib treatment continuation
11383644|NCT01698905|EG004|Reported Event|TFR-2 Phase|treatment-free remission 2
11383645|NCT01698905|EG005|Reported Event|NTRI-2 Phase|nilotinib treatment re-initiation 2
11383646|NCT01698905|EG006|Reported Event|NTCT-P Phase|nilotinib treatment prolonged continuation
11383647|NCT01698905|EG007|Reported Event|All Patients|All patients enrolled in the study
11383648|NCT01676350|BG000|Baseline|Standard of Care|Standard of care
11383649|NCT01676350|BG001|Baseline|IO Access|IO access
11383650|NCT01676350|BG002|Baseline|Total|Total of all reporting groups
11383651|NCT01676350|FG000|Participant Flow|Standard of Care|If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
11383652|NCT01676350|FG001|Participant Flow|&Apos;IO Access Using EZ-IO®|"If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.~IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®."
11383653|NCT01676350|OG000|Outcome|Standard of Care|If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
11195964|NCT02161575|FG000|Participant Flow|Ranibizumab|All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
11383654|NCT01676350|OG001|Outcome|&Apos;IO Access Using EZ-IO®|"If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.~IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®."
11383655|NCT01676350|OG001|Outcome|IO Access Using EZ-IO®|"If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.~IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®."
11383656|NCT01676350|EG000|Reported Event|Standard of Care|If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
11383657|NCT01676350|EG001|Reported Event|&Apos;IO Access Using EZ-IO®|"If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.~IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®."
11383658|NCT01630590|BG000|Baseline|Cabozantinib + Androgen Ablation Therapy|"Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.~Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle.~Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor."
11383659|NCT01630590|FG000|Participant Flow|Cabozantinib + Androgen Ablation Therapy|"Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.~Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle.~Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor."
11383660|NCT01630590|OG000|Outcome|Cabozantinib + Androgen Ablation Therapy|"Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.~Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle.~Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor."
11383661|NCT01630590|EG000|Reported Event|Cabozantinib + Androgen Ablation Therapy|"Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.~Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle.~Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor."
11383662|NCT01619085|BG000|Baseline|Total (1199.32/.34)|"This group included patients originated from parent trials 1199.32/.34.~For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.~In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis."
10794943|NCT00835406|BG000|Baseline|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
11383663|NCT01619085|FG000|Participant Flow|Total (1199.32/.34/.35/.187)|For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
11383664|NCT01619085|OG000|Outcome|Total (1199.32/.34)|"This group included patients originated from parent trials 1199.32/.34.~For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.~In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis."
11383665|NCT01619085|EG000|Reported Event|Total (1199.32/.34)|"This group included patients originated from parent trials 1199.32/.34.~For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.~In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis."
11383666|NCT01619085|EG001|Reported Event|Placebo (1199.32/.34)|Patients in this group are those who were randomized to placebo arm in parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.
11383667|NCT01619085|EG002|Reported Event|Nintedanib 150 Bid (1199.32/.34)|Patients in this group are those who were randomized to 150 milligrams nintedanib twice daily (bid) arm in the parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.
11383668|NCT01619085|EG003|Reported Event|Placebo (1199.187)|Patients in this group are those who were randomized to placebo arm in parent trial 1199.187 and were treated with 150 milligrams or 100 milligrams of nintedanib twice daily in this study.
11383669|NCT01619085|EG004|Reported Event|Nintedanib 100 Bid (1199.35)|Patients in this group are those who were participated in the parent trial 1199.35 and were treated with 100 milligrams of nintedanib twice daily (bid) in this study.
11383670|NCT01619085|EG005|Reported Event|Nintedanib 150 Bid (1199.35/.187)|Patients in this group are those who were treated with 150 milligrams (mg) of nintedanib twice daily (bid) in this study and were participated in parent trial 1199.35 plus those who were randomized to 150 mg nintedanib bid arm in the parent trial 1199.187 and were treated with 150 mg or 100 mg nintedanib bid in this study.
11383671|NCT01619085|EG006|Reported Event|Total (1199.35/.187)|"This group included patients originated from parent trials 1199.35/.187. For patients participated in parent trials 1199.35/.187, they were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 milligrams (mg) twice daily (bid) or 150 mg bid) in this study.~In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis."
10794944|NCT00835406|BG001|Baseline|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
10794945|NCT00835406|BG002|Baseline|Total|Total of all reporting groups
10794946|NCT00835406|FG000|Participant Flow|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
10794947|NCT00835406|FG001|Participant Flow|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
10794948|NCT00835406|OG000|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
10794949|NCT00835406|OG001|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
10794950|NCT00835367|BG000|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
10794951|NCT00835367|BG001|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
10794952|NCT00835367|BG002|Baseline|Total|Total of all reporting groups
10794953|NCT00835367|FG000|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
10794954|NCT00835367|FG001|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
10794955|NCT00835367|OG000|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
10794956|NCT00835367|OG001|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
10794957|NCT00835354|BG000|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
10794958|NCT00835354|BG001|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
10794959|NCT00835354|BG002|Baseline|Total|Total of all reporting groups
10794960|NCT00835354|FG000|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
10794961|NCT00835354|FG001|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
10794962|NCT00835354|OG000|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
10794963|NCT00835354|OG001|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
10794964|NCT00835276|BG000|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
10794965|NCT00835276|BG001|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
10794966|NCT00835276|BG002|Baseline|Total|Total of all reporting groups
10794967|NCT00835276|FG000|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
10794968|NCT00835276|FG001|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
10794969|NCT00835276|OG000|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
10794970|NCT00835276|OG001|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
10794971|NCT00835263|BG000|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
10794972|NCT00835263|BG001|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
10794973|NCT00835263|BG002|Baseline|Total|Total of all reporting groups
10794974|NCT00835263|FG000|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
10794975|NCT00835263|FG001|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
10794976|NCT00835263|OG000|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
10794977|NCT00835263|OG001|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
10794978|NCT00835211|BG000|Baseline|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
10794979|NCT00835211|BG001|Baseline|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
10794980|NCT00835211|BG002|Baseline|Total|Total of all reporting groups
10794981|NCT00835211|FG000|Participant Flow|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
10794982|NCT00835211|FG001|Participant Flow|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
10794983|NCT00835211|OG000|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
10794984|NCT00835211|OG001|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
10794985|NCT00835172|BG000|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
10794986|NCT00835172|BG001|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
10794987|NCT00835172|BG002|Baseline|Total|Total of all reporting groups
10794988|NCT00835172|FG000|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
10794989|NCT00835172|FG001|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
10794990|NCT00835172|OG000|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
10794991|NCT00835172|OG001|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
10794992|NCT00835146|BG000|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
10794993|NCT00835146|BG001|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
10794994|NCT00835146|BG002|Baseline|Total|Total of all reporting groups
10794995|NCT00835146|FG000|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
10794996|NCT00835146|FG001|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
10794997|NCT00835146|OG000|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
10794998|NCT00835146|OG001|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
10794999|NCT00835081|BG000|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
10795000|NCT00835081|BG001|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
10795001|NCT00835081|BG002|Baseline|Total|Total of all reporting groups
10795002|NCT00835081|FG000|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
10795003|NCT00835081|FG001|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
10795004|NCT00835081|OG000|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
10795005|NCT00835081|OG001|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
10795006|NCT00835042|BG000|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
10795007|NCT00835042|BG001|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
10795008|NCT00835042|BG002|Baseline|Total|Total of all reporting groups
10795009|NCT00835042|FG000|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
10795010|NCT00835042|FG001|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
10795011|NCT00835042|OG000|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
10795012|NCT00835042|OG001|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
10795013|NCT00834990|BG000|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
10795014|NCT00834990|BG001|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
10795015|NCT00834990|BG002|Baseline|Total|Total of all reporting groups
10795016|NCT00834990|FG000|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
10795017|NCT00834990|FG001|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
10795018|NCT00834990|OG000|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
10795019|NCT00834990|OG001|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
10795020|NCT00834977|BG000|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
10795021|NCT00834977|BG001|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
10795022|NCT00834977|BG002|Baseline|Total|Total of all reporting groups
10795023|NCT00834977|FG000|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
10795024|NCT00834977|FG001|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
10795025|NCT00834977|OG000|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
10795026|NCT00834977|OG001|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
10795027|NCT00834964|BG000|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
10795028|NCT00834964|BG001|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
10795029|NCT00834964|BG002|Baseline|Total|Total of all reporting groups
10795030|NCT00834964|FG000|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
10795031|NCT00834964|FG001|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
10795032|NCT00834964|OG000|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
10795033|NCT00834964|OG001|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
10795034|NCT00834873|BG000|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
10795035|NCT00834873|BG001|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
10795036|NCT00834873|BG002|Baseline|Total|Total of all reporting groups
10795037|NCT00834873|FG000|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
10795038|NCT00834873|FG001|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
10795039|NCT00834873|OG000|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
10795040|NCT00834873|OG001|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
10795041|NCT00834795|BG000|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
10795042|NCT00834795|BG001|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
10795043|NCT00834795|BG002|Baseline|Total|Total of all reporting groups
10795044|NCT00834795|FG000|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
10795045|NCT00834795|FG001|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
10795046|NCT00834795|OG000|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
10795047|NCT00834795|OG001|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
10795048|NCT00834756|BG000|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
10795049|NCT00834756|BG001|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
10795050|NCT00834756|BG002|Baseline|Total|Total of all reporting groups
10795051|NCT00834756|FG000|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
10795052|NCT00834756|FG001|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
10795053|NCT00834756|OG000|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
10795054|NCT00834756|OG001|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
10795055|NCT00834743|BG000|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
10795056|NCT00834743|BG001|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
10795057|NCT00834743|BG002|Baseline|Total|Total of all reporting groups
10795058|NCT00834743|FG000|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
10795059|NCT00834743|FG001|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
10795060|NCT00834743|OG000|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
10795061|NCT00834743|OG001|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
10795062|NCT00834717|BG000|Baseline|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
10795063|NCT00834717|BG001|Baseline|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
10795064|NCT00834717|BG002|Baseline|Total|Total of all reporting groups
10795065|NCT00834717|FG000|Participant Flow|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
10795066|NCT00834717|FG001|Participant Flow|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
10795067|NCT00834717|OG000|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
10795068|NCT00834717|OG001|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
10795069|NCT00834639|BG000|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
10795070|NCT00834639|BG001|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
10795071|NCT00834639|BG002|Baseline|Total|Total of all reporting groups
10795072|NCT00834639|FG000|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
10795073|NCT00834639|FG001|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
10795074|NCT00834639|OG000|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
10795075|NCT00834639|OG001|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
10795076|NCT00834613|BG000|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
10795077|NCT00834613|BG001|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
10795078|NCT00834613|BG002|Baseline|Total|Total of all reporting groups
10795079|NCT00834613|FG000|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
10795080|NCT00834613|FG001|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
10795081|NCT00834613|OG000|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
10795082|NCT00834613|OG001|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
10795083|NCT00834587|BG000|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
10795084|NCT00834587|BG001|Baseline|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
10795085|NCT00834587|BG002|Baseline|Total|Total of all reporting groups
10795086|NCT00834587|FG000|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
10795087|NCT00834587|FG001|Participant Flow|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
10795088|NCT00834587|OG000|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
10795089|NCT00834587|OG001|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
10795090|NCT00834574|BG000|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
10795091|NCT00834574|BG001|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
10795092|NCT00834574|BG002|Baseline|Total|Total of all reporting groups
10795093|NCT00834574|FG000|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
10795094|NCT00834574|FG001|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
10795095|NCT00834574|OG000|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
10795096|NCT00834574|OG001|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
10795097|NCT00834561|BG000|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
10795098|NCT00834561|BG001|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
10795099|NCT00834561|BG002|Baseline|Total|Total of all reporting groups
10795100|NCT00834561|FG000|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
10795101|NCT00834561|FG001|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
10795102|NCT00834561|OG000|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
10795103|NCT00834561|OG001|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
10795104|NCT00834535|BG000|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
10795105|NCT00834535|BG001|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
10795106|NCT00834535|BG002|Baseline|Total|Total of all reporting groups
10795107|NCT00834535|FG000|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
10795108|NCT00834535|FG001|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
10795109|NCT00834535|OG000|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
10795110|NCT00834535|OG001|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
10795111|NCT00834522|BG000|Baseline|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
10795112|NCT00834522|BG001|Baseline|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
10795113|NCT00834522|BG002|Baseline|Total|Total of all reporting groups
10795114|NCT00834522|FG000|Participant Flow|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
10795115|NCT00834522|FG001|Participant Flow|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
10795116|NCT00834522|OG000|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
10795117|NCT00834522|OG001|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
10795118|NCT00834444|BG000|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
10795119|NCT00834444|BG001|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
10795120|NCT00834444|BG002|Baseline|Total|Total of all reporting groups
10795121|NCT00834444|FG000|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
10795122|NCT00834444|FG001|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
10795123|NCT00834444|OG000|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
11195965|NCT02161575|OG000|Outcome|Ranibizumab|All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
10795124|NCT00834444|OG001|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
10795125|NCT00834431|BG000|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
10795126|NCT00834431|BG001|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
10795127|NCT00834431|BG002|Baseline|Total|Total of all reporting groups
10795128|NCT00834431|FG000|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
10795129|NCT00834431|FG001|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
10795130|NCT00834431|OG000|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
10795131|NCT00834431|OG001|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
10795132|NCT00834418|BG000|Baseline|Leflunomide|Leflunomide 20 mg Tablet
10795133|NCT00834418|BG001|Baseline|Arava™|Arava™ 20 mg Tablet
10795134|NCT00834418|BG002|Baseline|Total|Total of all reporting groups
10795135|NCT00834418|FG000|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
10795136|NCT00834418|FG001|Participant Flow|Arava™|Arava™ 20 mg Tablet
10795137|NCT00834418|OG000|Outcome|Leflunomide|Leflunomide 20 mg Tablet
10795138|NCT00834418|OG001|Outcome|Arava™|Arava™ 20 mg Tablet
10795139|NCT00834405|BG000|Baseline|Leflunomide|Leflunomide 20 mg Tablet
10795140|NCT00834405|BG001|Baseline|Arava®|Arava® 20 mg Tablet
10795141|NCT00834405|BG002|Baseline|Total|Total of all reporting groups
10795142|NCT00834405|FG000|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
10795143|NCT00834405|FG001|Participant Flow|Arava®|Arava® 20 mg Tablet
10795144|NCT00834405|OG000|Outcome|Leflunomide|Leflunomide 20 mg Tablet
10795145|NCT00834405|OG001|Outcome|Arava®|Arava® 20 mg Tablet
10795146|NCT00834340|BG000|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
10795147|NCT00834340|BG001|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
10795148|NCT00834340|BG002|Baseline|Total|Total of all reporting groups
10795149|NCT00834340|FG000|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
10795150|NCT00834340|FG001|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
10795151|NCT00834340|OG000|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
10795152|NCT00834340|OG001|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
10795153|NCT00834275|BG000|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
10795154|NCT00834275|BG001|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
10795155|NCT00834275|BG002|Baseline|Total|Total of all reporting groups
10795156|NCT00834275|FG000|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
10795157|NCT00834275|FG001|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
10795158|NCT00834275|OG000|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
10795159|NCT00834275|OG001|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
10795160|NCT00834249|BG000|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
10795161|NCT00834249|BG001|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
10795162|NCT00834249|BG002|Baseline|Total|Total of all reporting groups
10795163|NCT00834249|FG000|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
10795164|NCT00834249|FG001|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
10795165|NCT00834249|OG000|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
10795166|NCT00834249|OG001|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
10795167|NCT00834197|BG000|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
10795168|NCT00834197|BG001|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
10795169|NCT00834197|BG002|Baseline|Total|Total of all reporting groups
10795170|NCT00834197|FG000|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
10795171|NCT00834197|FG001|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
10795172|NCT00834197|OG000|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
10795173|NCT00834197|OG001|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
10795174|NCT00834132|BG000|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
10795175|NCT00834132|BG001|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
11195966|NCT02161575|EG000|Reported Event|Ranibizumab|All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
10795176|NCT00834132|BG002|Baseline|Total|Total of all reporting groups
10795177|NCT00834132|FG000|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
10795178|NCT00834132|FG001|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
10795179|NCT00834132|OG000|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
10795180|NCT00834132|OG001|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
10795181|NCT00834067|BG000|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
10795182|NCT00834067|BG001|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
10795183|NCT00834067|BG002|Baseline|Total|Total of all reporting groups
10795184|NCT00834067|FG000|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
10795185|NCT00834067|FG001|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
10795186|NCT00834067|OG000|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
10795187|NCT00834067|OG001|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
10795188|NCT00833937|BG000|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
10795189|NCT00833937|BG001|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
10795190|NCT00833937|BG002|Baseline|Total|Total of all reporting groups
10795191|NCT00833937|FG000|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
10795192|NCT00833937|FG001|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
10795193|NCT00833937|OG000|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
10795194|NCT00833937|OG001|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
10795195|NCT00833664|BG000|Baseline|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
10795196|NCT00833664|BG001|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
10795197|NCT00833664|BG002|Baseline|Total|Total of all reporting groups
10795198|NCT00833664|FG000|Participant Flow|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
10795199|NCT00833664|FG001|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
10795200|NCT00833664|OG000|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
10795201|NCT00833664|OG001|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
10795202|NCT00833586|BG000|Baseline|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
10795203|NCT00833586|BG001|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
10795204|NCT00833586|BG002|Baseline|Total|Total of all reporting groups
10795205|NCT00833586|FG000|Participant Flow|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
10795206|NCT00833586|FG001|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
10795207|NCT00833586|OG000|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
10795208|NCT00833586|OG001|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
10795209|NCT00833521|BG000|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
10795210|NCT00833521|BG001|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
10795211|NCT00833521|BG002|Baseline|Total|Total of all reporting groups
10795212|NCT00833521|FG000|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
10795213|NCT00833521|FG001|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
10795214|NCT00833521|OG000|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
10795215|NCT00833521|OG001|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
10795216|NCT00830336|BG000|Baseline|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
10795217|NCT00830336|BG001|Baseline|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
10795218|NCT00830336|BG002|Baseline|Total|Total of all reporting groups
10795219|NCT00830336|FG000|Participant Flow|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
10795220|NCT00830336|FG001|Participant Flow|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
10795221|NCT00830336|OG000|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
11195967|NCT02161705|BG000|Baseline|Ropivacaine Group|"Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).~Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block"
11195968|NCT02161705|BG001|Baseline|Saline Group|"Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.~Saline: Up to 0.8 mL/kg of normal saline administered"
10795222|NCT00830336|OG001|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
10795223|NCT00830258|BG000|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
10795224|NCT00830258|BG001|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
10795225|NCT00830258|BG002|Baseline|Total|Total of all reporting groups
10795226|NCT00830258|FG000|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
10795227|NCT00830258|FG001|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
10795228|NCT00830258|OG000|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
10795229|NCT00830258|OG001|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
10795230|NCT00830219|BG000|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
10795231|NCT00830219|BG001|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
10795232|NCT00830219|BG002|Baseline|Total|Total of all reporting groups
10795233|NCT00830219|FG000|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
10795234|NCT00830219|FG001|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
10795235|NCT00830219|OG000|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
10795236|NCT00830219|OG001|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
10795237|NCT00830206|BG000|Baseline|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
10795238|NCT00830206|BG001|Baseline|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
10795239|NCT00830206|BG002|Baseline|Total|Total of all reporting groups
10795240|NCT00830206|FG000|Participant Flow|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
10795241|NCT00830206|FG001|Participant Flow|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
10795242|NCT00830206|OG000|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
10795243|NCT00830206|OG001|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
10795244|NCT00830024|BG000|Baseline|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
10795245|NCT00830024|BG001|Baseline|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
10795246|NCT00830024|BG002|Baseline|Total|Total of all reporting groups
10795247|NCT00830024|FG000|Participant Flow|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
10795248|NCT00830024|FG001|Participant Flow|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
10795249|NCT00830024|OG000|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
10795250|NCT00830024|OG001|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
10795251|NCT00829998|BG000|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
10795252|NCT00829998|BG001|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
10795253|NCT00829998|BG002|Baseline|Total|Total of all reporting groups
11195969|NCT02161705|BG002|Baseline|Total|Total of all reporting groups
10795254|NCT00829998|FG000|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
10795255|NCT00829998|FG001|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
10795256|NCT00829998|OG000|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
10795257|NCT00829998|OG001|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
10795258|NCT00829868|BG000|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
10795259|NCT00829868|BG001|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
10795260|NCT00829868|BG002|Baseline|Total|Total of all reporting groups
10795261|NCT00829868|FG000|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
10795262|NCT00829868|FG001|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
10795263|NCT00829868|OG000|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
10795264|NCT00829868|OG001|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
10795265|NCT00829790|BG000|Baseline|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
10795266|NCT00829790|BG001|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
10795267|NCT00829790|BG002|Baseline|Total|Total of all reporting groups
10795268|NCT00829790|FG000|Participant Flow|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
10795269|NCT00829790|FG001|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
10795270|NCT00829790|OG000|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
10795271|NCT00829790|OG001|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
10795272|NCT00829764|BG000|Baseline|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
10795273|NCT00829764|BG001|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
10795274|NCT00829764|BG002|Baseline|Total|Total of all reporting groups
10795275|NCT00829764|FG000|Participant Flow|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
10795276|NCT00829764|FG001|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
10795277|NCT00829764|OG000|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
10795278|NCT00829764|OG001|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
10795279|NCT00829712|BG000|Baseline|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
10795280|NCT00829712|BG001|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
10795281|NCT00829712|BG002|Baseline|Total|Total of all reporting groups
10795282|NCT00829712|FG000|Participant Flow|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
10795283|NCT00829712|FG001|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
10795284|NCT00829712|OG000|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
10795285|NCT00829712|OG001|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
10795286|NCT00829686|BG000|Baseline|No Intervention|No antibiotic
11195970|NCT02161705|FG000|Participant Flow|Ropivacaine Group|"Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).~Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block"
11195971|NCT02161705|FG001|Participant Flow|Saline Group|"Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.~Saline: Up to 0.8 mL/kg of normal saline administered"
10795287|NCT00829686|BG001|Baseline|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
10795288|NCT00829686|BG002|Baseline|Total|Total of all reporting groups
11195972|NCT02161705|OG000|Outcome|Ropivacaine Group|"Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).~Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block"
11195973|NCT02161705|OG001|Outcome|Saline Group|"Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.~Saline: Up to 0.8 mL/kg of normal saline administered"
10795289|NCT00829686|FG000|Participant Flow|No Intervention|No antibiotic
10795290|NCT00829686|FG001|Participant Flow|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
10795291|NCT00829686|OG000|Outcome|No Intervention|No antibiotic
10795292|NCT00829686|OG001|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
10795293|NCT00829673|BG000|Baseline|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
10795294|NCT00829673|BG001|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
10795295|NCT00829673|BG002|Baseline|Total|Total of all reporting groups
10795296|NCT00829673|FG000|Participant Flow|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
10795297|NCT00829673|FG001|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
10795298|NCT00829673|OG000|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
10795299|NCT00829673|OG001|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
10795300|NCT00829530|BG000|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
10795301|NCT00829530|BG001|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795302|NCT00829530|BG002|Baseline|Total|Total of all reporting groups
10795303|NCT00829530|FG000|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
10795304|NCT00829530|FG001|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795305|NCT00829530|OG000|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
10795306|NCT00829530|OG001|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
10795307|NCT00829504|BG000|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
10795308|NCT00829504|BG001|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
10795309|NCT00829504|BG002|Baseline|Total|Total of all reporting groups
10795310|NCT00829504|FG000|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
10795311|NCT00829504|FG001|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
10795312|NCT00829504|OG000|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
10795313|NCT00829504|OG001|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
10795314|NCT00829452|BG000|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
10795315|NCT00829452|BG001|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795316|NCT00829452|BG002|Baseline|Total|Total of all reporting groups
10795317|NCT00829452|FG000|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
10795318|NCT00829452|FG001|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795319|NCT00829452|OG000|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
10795320|NCT00829452|OG001|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
10795321|NCT00829426|BG000|Baseline|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
10795322|NCT00829426|BG001|Baseline|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
10795323|NCT00829426|BG002|Baseline|Total|Total of all reporting groups
10795324|NCT00829426|FG000|Participant Flow|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
10795325|NCT00829426|FG001|Participant Flow|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
11195974|NCT02161705|EG000|Reported Event|Ropivacaine Group|"Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).~Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block"
11195975|NCT02161705|EG001|Reported Event|Saline Group|"Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.~Saline: Up to 0.8 mL/kg of normal saline administered"
10795326|NCT00829426|OG000|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
10795327|NCT00829426|OG001|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
10795328|NCT00829309|BG000|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
10795329|NCT00829309|BG001|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
10795330|NCT00829309|BG002|Baseline|Total|Total of all reporting groups
10795331|NCT00829309|FG000|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
10795332|NCT00829309|FG001|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
10795333|NCT00829309|OG000|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
10795334|NCT00829309|OG001|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
10795335|NCT00828321|BG000|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
11195976|NCT02161718|BG000|Baseline|ALKS 3831|"Oral tablet, taken once daily~ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)"
11195977|NCT02161718|BG001|Baseline|Olanzapine + Placebo|"Oral tablet, taken once daily~Olanzapine dose level determined by investigator"
10795336|NCT00828321|BG001|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795337|NCT00828321|BG002|Baseline|Total|Total of all reporting groups
10795338|NCT00828321|FG000|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
10795339|NCT00828321|FG001|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
10795340|NCT00828321|OG000|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
10795341|NCT00828321|OG001|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
10803015|NCT03828383|OG000|Outcome|In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display."
10795342|NCT00806403|BG000|Baseline|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
10795343|NCT00806403|BG001|Baseline|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
10795344|NCT00806403|BG002|Baseline|Total|Total of all reporting groups
10795345|NCT00806403|FG000|Participant Flow|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
10795346|NCT00806403|FG001|Participant Flow|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
10795347|NCT00806403|OG000|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
10795348|NCT00806403|OG001|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
10795349|NCT00803517|BG000|Baseline|Photodynamic Therapy|
11195978|NCT02161718|BG002|Baseline|Total|Total of all reporting groups
11195979|NCT02161718|FG000|Participant Flow|Open-label ALKS 3831|Oral tablet, taken once daily ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)
11195980|NCT02161718|FG001|Participant Flow|ALKS 3831|"Oral tablet, taken once daily~ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)"
10795350|NCT00803517|BG001|Baseline|Focal Laser Photocoagulation|
10795351|NCT00803517|BG002|Baseline|Total|Total of all reporting groups
10795352|NCT00803517|FG000|Participant Flow|Photodynamic Therapy|
10795353|NCT00803517|FG001|Participant Flow|Focal Laser Photocoagulation|
10795354|NCT00803517|OG000|Outcome|Photodynamic Therapy|
10795355|NCT00803517|OG001|Outcome|Focal Laser Photocoagulation|
10795356|NCT00803413|BG000|Baseline|Back School|
10795357|NCT00803413|BG001|Baseline|Supervised Walking|
10795358|NCT00803413|BG002|Baseline|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
10795359|NCT00803413|BG003|Baseline|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
10795360|NCT00803413|BG004|Baseline|Total|Total of all reporting groups
10795361|NCT00803413|FG000|Participant Flow|Back School|
10795362|NCT00803413|FG001|Participant Flow|Supervised Walking|
10795363|NCT00803413|FG002|Participant Flow|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
10795364|NCT00803413|FG003|Participant Flow|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
10795365|NCT00803413|OG000|Outcome|Back School|
10795366|NCT00803413|OG001|Outcome|Supervised Walking|
10795367|NCT00803413|OG002|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
10795368|NCT00803413|OG003|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
10795369|NCT00803114|BG000|Baseline|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
10795370|NCT00803114|BG001|Baseline|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
10795371|NCT00803114|BG002|Baseline|Total|Total of all reporting groups
11195981|NCT02161718|FG002|Participant Flow|Olanzapine + Placebo|"Oral tablet, taken once daily~Olanzapine dose level determined by investigator"
11195982|NCT02161718|OG000|Outcome|ALKS 3831|"Oral tablet, taken once daily~ALKS 3831: Olanzapine (dose level determined by investigator) + Samidorphan (10mg)"
11195983|NCT02161718|OG001|Outcome|Olanzapine + Placebo|"Oral tablet, taken once daily~Olanzapine dose level determined by investigator"
10795372|NCT00803114|FG000|Participant Flow|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
10795373|NCT00803114|FG001|Participant Flow|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
10795374|NCT00803114|OG000|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
10795375|NCT00803114|OG001|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
10795376|NCT00799292|BG000|Baseline|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
10795377|NCT00799292|BG001|Baseline|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
10795378|NCT00799292|BG002|Baseline|Total|Total of all reporting groups
10795379|NCT00799292|FG000|Participant Flow|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
11195984|NCT02161718|EG000|Reported Event|Open- Label ALKS 3831|A 2-week open-label period; all subjects received olanzapine (dose determined by investigator) + 10 mg samidorphan
11195985|NCT02161718|EG001|Reported Event|Olanzapine + Placebo|All randomized subjects who received at least 1 dose of study drug (olanzapine + placebo) during the double-blind treatment period
11195986|NCT02161718|EG002|Reported Event|ALKS 3831|All randomized subjects who received at least 1 dose of ALKS 3831 (olanzapine + samidorphan) during the double-blind treatment period.
11195987|NCT02161731|BG000|Baseline|Warfarin Then Evacetrapib + Warfarin|15 mg warfarin administered as a single oral dose on Day 1. Evacetrapib administered QD, orally, for 16 days, Days 7- 22 with 15 mg warfarin co-administered once orally on Day 17.
11195988|NCT02161731|FG000|Participant Flow|Warfarin|15 milligram (mg) warfarin administered as a single oral dose on Day 1.
11195989|NCT02161731|FG001|Participant Flow|Evacetrapib + Warfarin|Evacetrapib administered once daily (QD), orally, for 16 days on Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
11195990|NCT02161731|OG000|Outcome|Warfarin|15 mg warfarin administered as a single oral dose on Day 1.
11195991|NCT02161731|OG001|Outcome|Evacetrapib + Warfarin|Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
11195992|NCT02161731|EG000|Reported Event|15 mg Warfarin|15 milligram (mg) warfarin administered as a single oral dose on Day 1.
10795380|NCT00799292|FG001|Participant Flow|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
10795381|NCT00799292|OG000|Outcome|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
10795382|NCT00799292|OG001|Outcome|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
10795383|NCT00796523|BG000|Baseline|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
10795384|NCT00796523|BG001|Baseline|Control Videotape|videotape with normal newborn instruction
10795385|NCT00796523|BG002|Baseline|Total|Total of all reporting groups
10795386|NCT00796523|FG000|Participant Flow|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
10795387|NCT00796523|FG001|Participant Flow|Control Videotape|videotape with normal newborn instruction
10795388|NCT00796523|OG000|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
10795389|NCT00796523|OG001|Outcome|Control Videotape|videotape with normal newborn instruction
10795390|NCT00794924|BG000|Baseline|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
10795391|NCT00794924|BG001|Baseline|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
10795392|NCT00794924|BG002|Baseline|Total|Total of all reporting groups
10795393|NCT00794924|FG000|Participant Flow|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
10795394|NCT00794924|FG001|Participant Flow|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
10795395|NCT00794924|OG000|Outcome|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
10795396|NCT00794924|OG001|Outcome|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
10795397|NCT00794677|BG000|Baseline|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
10795398|NCT00794677|BG001|Baseline|Placebo|Placebo once daily received as the first or second intervention
10795399|NCT00794677|BG002|Baseline|Total|Total of all reporting groups
10795400|NCT00794677|FG000|Participant Flow|Placebo First|Placebo once daily in first intervention period and ezetimibe (10 mg/day) in second intervention period
10795401|NCT00794677|FG001|Participant Flow|Ezetimibe First|Ezetimibe (10 mg/day) once daily in the first intervention period and placebo once daily in the second intervention period
10795402|NCT00794677|OG000|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
10795403|NCT00794677|OG001|Outcome|Placebo|Placebo once daily received as the first or second intervention
10795404|NCT00792116|BG000|Baseline|Gum Chewing|
10795405|NCT00792116|BG001|Baseline|Non-Gum Chewing|
10795406|NCT00792116|BG002|Baseline|Total|Total of all reporting groups
10795407|NCT00792116|FG000|Participant Flow|Gum Chewing|
10795408|NCT00792116|FG001|Participant Flow|Non-Gum Chewing|
10795409|NCT00792116|OG000|Outcome|Gum Chewing|
10795410|NCT00792116|OG001|Outcome|Non-Gum Chewing|
10795411|NCT00758563|BG000|Baseline|Fluoride|
10795412|NCT00758563|BG001|Baseline|Triclosan|
10795413|NCT00758563|BG002|Baseline|Total|Total of all reporting groups
10795414|NCT00758563|FG000|Participant Flow|Fluoride|
10795415|NCT00758563|FG001|Participant Flow|Triclosan|
10795416|NCT00758563|OG000|Outcome|Fluoride|
10795417|NCT00758563|OG001|Outcome|Triclosan|
10795418|NCT00758290|BG000|Baseline|Fluoride/Triclosan|
10795419|NCT00758290|BG001|Baseline|Triclosan/Fluoride|
10795420|NCT00758290|BG002|Baseline|Total|Total of all reporting groups
10795421|NCT00758290|FG000|Participant Flow|Fluoride/Triclosan|
10795422|NCT00758290|FG001|Participant Flow|Triclosan/Fluoride|
10795423|NCT00758290|OG000|Outcome|Fluoride/Triclosan|
11195993|NCT02161731|EG001|Reported Event|130 mg Evacetrapib|130 mg Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22.
10795424|NCT00758290|OG001|Outcome|Triclosan/Fluoride|
11195994|NCT02161731|EG002|Reported Event|15 mg Warfarin + 130 mg Evacetrapib|Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22 with 15 milligram (mg) warfarin co-administered once orally on Day 17.
10795425|NCT00756574|BG000|Baseline|1. Surgical|surgical mask
10795426|NCT00756574|BG001|Baseline|2. N95 Respirator|N95 respirator
10795427|NCT00756574|BG002|Baseline|Total|Total of all reporting groups
10795428|NCT00756574|FG000|Participant Flow|1. Surgical|surgical mask
10795429|NCT00756574|FG001|Participant Flow|2. N95 Respirator|N95 respirator
10795430|NCT00756574|OG000|Outcome|1. Surgical|surgical mask
10795431|NCT00756574|OG001|Outcome|2. N95 Respirator|N95 respirator
10795432|NCT00740727|BG000|Baseline|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
10795433|NCT00740727|FG000|Participant Flow|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
10795434|NCT00740727|OG000|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
10795435|NCT00740480|BG000|Baseline|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
10795436|NCT00740480|FG000|Participant Flow|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
10795437|NCT00740480|OG000|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
10795438|NCT00724698|BG000|Baseline|Desloratadine|Desloratadine 5 mg daily
10795439|NCT00724698|FG000|Participant Flow|Desloratadine|Desloratadine 5 mg daily
10795440|NCT00724698|OG000|Outcome|Desloratadine|Desloratadine 5 mg daily
10795441|NCT00711555|BG000|Baseline|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
10795442|NCT00711555|FG000|Participant Flow|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
10795443|NCT00711555|OG000|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
10803016|NCT03828383|OG001|Outcome|Limited In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur."
10803017|NCT03828383|EG000|Reported Event|In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display."
10803018|NCT03828383|EG001|Reported Event|Limited In-Home Technology System|"The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).~Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur."
10803019|NCT03817853|BG000|Baseline|All Participants|Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
10850753|NCT00304265|FG001|Participant Flow|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
10795444|NCT00676494|BG000|Baseline|All Patients|Patients meeting eligibility criteria and enrolled in the study.
10795445|NCT00676494|FG000|Participant Flow|All Patients|Patients meeting eligibility criteria and enrolled in the study.
10795446|NCT00676494|OG000|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
10795447|NCT00662389|BG000|Baseline|A--Thermal Wand Application|
10795448|NCT00662389|FG000|Participant Flow|A--Thermal Wand Application|
10795449|NCT00662389|OG000|Outcome|A--Thermal Wand Application|
10795464|NCT00581477|BG000|Baseline|Patients With Dopamine Beta-hydroxylase Deficiency|Patients with known or suspected dopamine beta-hydroxylase deficiency were treated with droxidopa up to 300 mg three time daily. Supine and upright blood pressures were subsequently measured and the length of time the patients were able to stand was ascertained.
10795465|NCT00581477|FG000|Participant Flow|Patients With Dopamine Beta-Hydroxylase Deficiency|Patients with known or suspected dopamine beta-hydroxylase deficiency were treated with droxidopa up to 300 mg three time daily. Supine and upright blood pressures were subsequently measured and the length of time the patients were able to stand was ascertained.
10795466|NCT00581477|OG000|Outcome|Droxidopa 25 mg|Participants received up to 3 doses of Droxidopa 25 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795467|NCT00581477|OG001|Outcome|Droxidopa 50 mg|Participants received up to 3 doses of Droxidopa 50 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795468|NCT00581477|OG002|Outcome|Droxidopa 100 mg|Participants received up to 3 doses of Droxidopa 100 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795469|NCT00581477|OG003|Outcome|Droxidopa 200 mg|Participants received up to 3 doses of Droxidopa 200 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795470|NCT00581477|OG004|Outcome|Droxidopa 250 mg|Participants received up to 3 doses of Droxidopa 250 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795471|NCT00581477|OG005|Outcome|Droxidopa 300 mg|Participants received up to 3 doses of Droxidopa 300 mg on Study Day 1, 2, 3 or 4. Individual dosing was dependent on how well the drug was tolerated and the degree of improvement in orthostatic signs and symptoms.
10795472|NCT00581477|EG000|Reported Event|Droxidopa 25 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
10795473|NCT00581477|EG001|Reported Event|Droxidopa 50 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
10795474|NCT00581477|EG002|Reported Event|Droxidopa 100 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
10795475|NCT00581477|EG003|Reported Event|Droxidopa 200 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
10795476|NCT00581477|EG004|Reported Event|Droxidopa 250 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
11195995|NCT02161757|BG000|Baseline|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.
11195996|NCT02161757|BG001|Baseline|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
10795477|NCT00581477|EG005|Reported Event|Droxidopa 300 mg|Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were treated with up to 3 doses per day.
10803020|NCT03817853|FG000|Participant Flow|All Participants|Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
10803021|NCT03817853|FG001|Participant Flow|Maintenance|Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
10803022|NCT03817853|FG002|Participant Flow|Follow-up|Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
10803023|NCT03817853|OG000|Outcome|All Participants|Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
10850754|NCT00304265|OG000|Outcome|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
11195997|NCT02161757|BG002|Baseline|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
11195998|NCT02161757|BG003|Baseline|Total|Total of all reporting groups
10795450|NCT00659061|BG000|Baseline|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795451|NCT00659061|BG001|Baseline|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795452|NCT00659061|BG002|Baseline|Total|Total of all reporting groups
10795453|NCT00659061|FG000|Participant Flow|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795454|NCT00659061|FG001|Participant Flow|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795455|NCT00659061|OG000|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795456|NCT00659061|OG001|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
10795457|NCT00654992|BG000|Baseline|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
10795458|NCT00654992|BG001|Baseline|Placebo Group|received normal saline intraveously following induction of anesthesia
10795459|NCT00654992|BG002|Baseline|Total|Total of all reporting groups
10795460|NCT00654992|FG000|Participant Flow|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
10795461|NCT00654992|FG001|Participant Flow|Placebo Group|received normal saline intraveously following induction of anesthesia
10795462|NCT00654992|OG000|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
11195999|NCT02161757|FG000|Participant Flow|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.
11196000|NCT02161757|FG001|Participant Flow|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
11202248|NCT02206607|EG002|Reported Event|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10795463|NCT00654992|OG001|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
10795478|NCT00554294|BG000|Baseline|Control Group|Schools did not receive any intervention.
10795479|NCT00554294|BG001|Baseline|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
10795480|NCT00554294|BG002|Baseline|Total|Total of all reporting groups
10795481|NCT00554294|FG000|Participant Flow|Control Group|Schools did not receive any intervention.
10795482|NCT00554294|FG001|Participant Flow|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
10795483|NCT00554294|OG000|Outcome|Control Group|Schools did not receive any intervention.
10795484|NCT00554294|OG001|Outcome|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
10795485|NCT00554190|BG000|Baseline|AdvaCoat and Merogel Injectable|AdvaCoat compared with Merogel Injectable
10795486|NCT00554190|FG000|Participant Flow|AdvaCoat and Merogel|AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.
10795487|NCT00554190|OG000|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
10795488|NCT00554190|OG001|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
10795489|NCT00546273|BG000|Baseline|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
10795490|NCT00546273|BG001|Baseline|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
10795491|NCT00546273|BG002|Baseline|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
10795492|NCT00546273|BG003|Baseline|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
10795493|NCT00546273|BG004|Baseline|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
10795494|NCT00546273|BG005|Baseline|Total|Total of all reporting groups
10795495|NCT00546273|FG000|Participant Flow|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
10795496|NCT00546273|FG001|Participant Flow|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
10795497|NCT00546273|FG002|Participant Flow|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
10795498|NCT00546273|FG003|Participant Flow|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
10795499|NCT00546273|FG004|Participant Flow|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
10795500|NCT00546273|OG000|Outcome|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
10795501|NCT00546273|OG001|Outcome|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
10795502|NCT00546273|OG002|Outcome|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
10795503|NCT00546273|OG003|Outcome|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
10795504|NCT00546273|OG004|Outcome|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
10795505|NCT00529152|BG000|Baseline|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
10795506|NCT00529152|FG000|Participant Flow|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
10795507|NCT00529152|OG000|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
10795508|NCT00526227|BG000|Baseline|Secura Implant|Patients implanted with Secura device
10795509|NCT00526227|FG000|Participant Flow|Secura ICD Implant|Participants were implanted with a Secura Implantable Cardiac Defibrillator (ICD)
10795510|NCT00526227|OG000|Outcome|Secura Implant|Patients implanted with a Secura device
10795511|NCT00526227|OG000|Outcome|Secura Implant|The first 21 patients implanted with a Secura device that has a successful Holter recording
10795512|NCT00526227|OG000|Outcome|Secura ICD Implant|Participants were implanted with a Secura ICD
10795513|NCT00513617|BG000|Baseline|Low Dose|0.05 g/kg/day of Arginine in capsule form
10795514|NCT00513617|BG001|Baseline|High Dose|0.10 g/kg/day of Arginine in capsule form
10795515|NCT00513617|BG002|Baseline|Placebo|
10795516|NCT00513617|BG003|Baseline|Total|Total of all reporting groups
10795517|NCT00513617|FG000|Participant Flow|Low Dose|0.05 g/kg/day of Arginine in capsule form
10795518|NCT00513617|FG001|Participant Flow|High Dose|0.10 g/kg/day of Arginine in capsule form
10795519|NCT00513617|FG002|Participant Flow|Placebo|
10795520|NCT00513617|OG000|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
10795521|NCT00513617|OG001|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
10795522|NCT00513617|OG002|Outcome|Placebo|
10803024|NCT03817853|OG001|Outcome|Maintenance: Obinutuzumab|"Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.~Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression)."
10803025|NCT03817853|OG002|Outcome|Follow-up|Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
10803026|NCT03817853|EG000|Reported Event|All Participants|Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
10803027|NCT03817853|EG001|Reported Event|Maintenance|Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
10803028|NCT03817853|EG002|Reported Event|Follow-up|Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
10803029|NCT03717480|BG000|Baseline|TCR α/β Reagent System|"The stem cell apheresis product was depleted of TCRαβ T cells by negative selection using the automated CliniMACS® Plus device.~CD34+ stem cell counts were obtained before and after processing with the Miltenyi ClinicMACs device.~ClinicMACs: The Reagent System removed certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it was given to participants."
10803030|NCT03717480|FG000|Participant Flow|TCR α/β Reagent System|"The stem cell apheresis product was depleted of TCRαβ T cells by negative selection using the automated CliniMACS® Plus device.~CD34+ stem cell counts were obtained before and after processing with the Miltenyi ClinicMACs device.~ClinicMACs: The Reagent System removed certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it was given to participants."
10803031|NCT03717480|OG000|Outcome|TCR α/β Reagent System|"The stem cell apheresis product was depleted of TCRαβ T cells by negative selection using the automated CliniMACS® Plus device.~CD34+ stem cell counts were obtained before and after processing with the Miltenyi ClinicMACs device.~ClinicMACs: The Reagent System removed certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it was given to participants."
10803032|NCT03717480|EG000|Reported Event|TCR α/β Reagent System|"The stem cell apheresis product was depleted of TCRαβ T cells by negative selection using the automated CliniMACS® Plus device.~CD34+ stem cell counts were obtained before and after processing with the Miltenyi ClinicMACs device.~ClinicMACs: The Reagent System removed certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it was given to participants."
10803033|NCT03615066|BG000|Baseline|Selgantolimod 3 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10849950|NCT00299182|EG005|Reported Event|3 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10795523|NCT00495222|BG000|Baseline|Tissue Plication|
10795524|NCT00495222|FG000|Participant Flow|Tissue Plication|
10795525|NCT00495222|OG000|Outcome|Tissue Plication|
10795526|NCT00495131|BG000|Baseline|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
10795527|NCT00495131|BG001|Baseline|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
10795528|NCT00495131|BG002|Baseline|Total|Total of all reporting groups
10795529|NCT00495131|FG000|Participant Flow|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
10795530|NCT00495131|FG001|Participant Flow|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
10795531|NCT00495131|OG000|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
10795532|NCT00495131|OG001|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
10795533|NCT00491738|BG000|Baseline|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795534|NCT00491738|BG001|Baseline|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795535|NCT00491738|BG002|Baseline|Total|Total of all reporting groups
10795536|NCT00491738|FG000|Participant Flow|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795537|NCT00491738|FG001|Participant Flow|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795538|NCT00491738|OG000|Outcome|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795539|NCT00491738|OG001|Outcome|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
10795540|NCT00484419|BG000|Baseline|Colesevelam|colesevelam tablets 625 mg
10795541|NCT00484419|BG001|Baseline|Rosiglitazone|rosiglitazone maleate 4mg
10795542|NCT00484419|BG002|Baseline|Sitagliptin|sitagliptin phosphate tablets 100mg
10795543|NCT00484419|BG003|Baseline|Total|Total of all reporting groups
10795544|NCT00484419|FG000|Participant Flow|Colesevelam|colesevelam tablets 625 mg
10795545|NCT00484419|FG001|Participant Flow|Rosiglitazone|rosiglitazone maleate 4mg
10795546|NCT00484419|FG002|Participant Flow|Sitagliptin|sitagliptin phosphate tablets 100mg
10795547|NCT00484419|OG000|Outcome|Colesevelam|colesevelam tablets 625 mg
10795548|NCT00484419|OG001|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
10795549|NCT00484419|OG002|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
10795550|NCT00479258|BG000|Baseline|Inhaled Insulin (Exubera)|No subjects received study medication.
10795551|NCT00479258|BG001|Baseline|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
10795552|NCT00479258|BG002|Baseline|Total|Total of all reporting groups
10795553|NCT00479258|FG000|Participant Flow|Inhaled Insulin (Exubera)|No subjects received study medication.
10795554|NCT00479258|FG001|Participant Flow|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
10795555|NCT00479258|OG000|Outcome|Inhaled Insulin (Exubera)|No subjects received study medication.
10795556|NCT00479258|OG001|Outcome|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
10795557|NCT00474188|BG000|Baseline|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
10795558|NCT00474188|FG000|Participant Flow|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
10795559|NCT00474188|OG000|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
10795560|NCT00440531|BG000|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
10795561|NCT00440531|BG001|Baseline|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
10795562|NCT00440531|BG002|Baseline|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
10795563|NCT00440531|BG003|Baseline|Total|Total of all reporting groups
10795564|NCT00440531|FG000|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
10795565|NCT00440531|FG001|Participant Flow|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
10795566|NCT00440531|FG002|Participant Flow|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
10795567|NCT00440531|OG000|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
10795568|NCT00440531|OG001|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
10795569|NCT00440531|OG000|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
10795570|NCT00440531|OG002|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
10795571|NCT00439738|BG000|Baseline|Valsartan/HCTZ (Hydrochlorothiazide)|
10795572|NCT00439738|BG001|Baseline|HCTZ +Amlodipine|
10795573|NCT00439738|BG002|Baseline|Total|Total of all reporting groups
10795574|NCT00439738|FG000|Participant Flow|Valsartan/HCTZ (Hydrochlorothiazide)|
10795575|NCT00439738|FG001|Participant Flow|HCTZ +Amlodipine|
10795576|NCT00439738|OG000|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
10795577|NCT00439738|OG001|Outcome|HCTZ +Amlodipine|
10795578|NCT00434226|BG000|Baseline|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
10795579|NCT00434226|BG001|Baseline|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
10795580|NCT00434226|BG002|Baseline|Total|Total of all reporting groups
10795581|NCT00434226|FG000|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
10795582|NCT00434226|FG001|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
10795583|NCT00434226|OG000|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
10795584|NCT00434226|OG001|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
10795585|NCT00430950|BG000|Baseline|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
10795586|NCT00430950|BG001|Baseline|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
10795587|NCT00430950|BG002|Baseline|Total|Total of all reporting groups
10795588|NCT00430950|FG000|Participant Flow|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
10795589|NCT00430950|FG001|Participant Flow|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
10795590|NCT00430950|OG000|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
10795591|NCT00430950|OG001|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
10795592|NCT00430508|BG000|Baseline|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
10795593|NCT00430508|BG001|Baseline|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
10795594|NCT00430508|BG002|Baseline|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
10795595|NCT00430508|BG003|Baseline|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
10795596|NCT00430508|BG004|Baseline|Total|Total of all reporting groups
10795597|NCT00430508|FG000|Participant Flow|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
10795598|NCT00430508|FG001|Participant Flow|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
10795599|NCT00430508|FG002|Participant Flow|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
10795600|NCT00430508|FG003|Participant Flow|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
10795601|NCT00430508|OG000|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
10795602|NCT00430508|OG001|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
10795603|NCT00430508|OG002|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
10795604|NCT00430508|OG003|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
10795605|NCT00430092|BG000|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
10795606|NCT00430092|BG001|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
10795607|NCT00430092|BG002|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795608|NCT00430092|BG003|Baseline|Total|Total of all reporting groups
10795609|NCT00430092|FG000|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
10795610|NCT00430092|FG001|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
10795611|NCT00430092|FG002|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795612|NCT00430092|OG000|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
10795613|NCT00430092|OG001|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
10795614|NCT00430092|OG002|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795615|NCT00429923|BG000|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
10795616|NCT00429923|BG001|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
10795617|NCT00429923|BG002|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795618|NCT00429923|BG003|Baseline|Total|Total of all reporting groups
10795619|NCT00429923|FG000|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
10795620|NCT00429923|FG001|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
10795621|NCT00429923|FG002|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795622|NCT00429923|OG000|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
10795623|NCT00429923|OG001|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
10795624|NCT00429923|OG002|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
10795625|NCT00425100|BG000|Baseline|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
10795626|NCT00425100|FG000|Participant Flow|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
10795627|NCT00425100|OG000|Outcome|Open Label Baseline|
10795628|NCT00425100|OG001|Outcome|Open Label Week 12|
10795629|NCT00425100|OG000|Outcome|Open Label Week 12|
10795630|NCT00415623|BG000|Baseline|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
10795631|NCT00415623|BG001|Baseline|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
11202249|NCT02206607|EG003|Reported Event|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10795632|NCT00415623|BG002|Baseline|Total|Total of all reporting groups
10795633|NCT00415623|FG000|Participant Flow|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
10795634|NCT00415623|FG001|Participant Flow|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
10795635|NCT00415623|OG000|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
10795636|NCT00415623|OG001|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
10795637|NCT00415623|OG000|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
10795638|NCT00415623|OG001|Outcome|Week 4|
10795639|NCT00415623|OG002|Outcome|Week 8|
10795640|NCT00412932|BG000|Baseline|Active Treatment Period|All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
10795641|NCT00412932|FG000|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
10795642|NCT00412932|OG000|Outcome|Overall Study|
10795643|NCT00397254|BG000|Baseline|Baseline Period - Rizatriptan 9 Tablets|Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
10795644|NCT00397254|FG000|Participant Flow|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
10795645|NCT00397254|FG001|Participant Flow|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
10795646|NCT00397254|OG000|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
10795647|NCT00397254|OG001|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
10803034|NCT03615066|BG001|Baseline|Selgantolimod 1.5 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10795648|NCT00393068|BG000|Baseline|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
10795649|NCT00393068|FG000|Participant Flow|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
10795650|NCT00393068|OG000|Outcome|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
10795651|NCT00393068|EG000|Reported Event|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
10795652|NCT00385515|BG000|Baseline|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
10795653|NCT00385515|BG001|Baseline|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
10795654|NCT00385515|BG002|Baseline|Total|Total of all reporting groups
10795655|NCT00385515|FG000|Participant Flow|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
10795656|NCT00385515|FG001|Participant Flow|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
10795657|NCT00385515|OG000|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
10795658|NCT00385515|OG001|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
10795659|NCT00362401|BG000|Baseline|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795660|NCT00362401|BG001|Baseline|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795661|NCT00362401|BG002|Baseline|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795662|NCT00362401|BG003|Baseline|Total|Total of all reporting groups
10795663|NCT00362401|FG000|Participant Flow|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795664|NCT00362401|FG001|Participant Flow|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795665|NCT00362401|FG002|Participant Flow|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795666|NCT00362401|OG000|Outcome|Group 1 - ATS|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795667|NCT00362401|OG001|Outcome|Group 2- Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795668|NCT00362401|OG002|Outcome|Group 3 - St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
10795669|NCT00338104|BG000|Baseline|40% Group|Glargine at 40% of insulin drip rate
10795670|NCT00338104|BG001|Baseline|60% Group|Glargine at 60% of insulin drip rate
10795671|NCT00338104|BG002|Baseline|80% Group|Glargine at 80% of insulin drip rate
10795672|NCT00338104|BG003|Baseline|Total|Total of all reporting groups
10795673|NCT00338104|FG000|Participant Flow|40% Group|Glargine at 40% of insulin drip rate
10795674|NCT00338104|FG001|Participant Flow|60% Group|Glargine at 60% of insulin drip rate
10795675|NCT00338104|FG002|Participant Flow|80% Group|Glargine at 80% of insulin drip rate
11196001|NCT02161757|FG002|Participant Flow|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
11196002|NCT02161757|OG000|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.
11196003|NCT02161757|OG001|Outcome|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
11196004|NCT02161757|OG002|Outcome|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
11196005|NCT02161757|EG000|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.
11196006|NCT02161757|EG001|Reported Event|Tralo 300 mg Q4W|Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.
11196007|NCT02161757|EG002|Reported Event|Placebo|Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
11196008|NCT02162433|BG000|Baseline|1. Awake Extubation/Dexmedetomidine|"Awake extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
10795676|NCT00338104|OG000|Outcome|40% Group|Glargine at 40% of insulin drip rate
10795677|NCT00338104|OG001|Outcome|60% Group|Glargine at 60% of insulin drip rate
10795678|NCT00338104|OG002|Outcome|80% Group|Glargine at 80% of insulin drip rate
11196009|NCT02162433|BG001|Baseline|2. Awake Extubation/Placebo|"Awake extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196010|NCT02162433|BG002|Baseline|3.Deep Extubation/Dexmedetomidine|"Deep extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196011|NCT02162433|BG003|Baseline|4. Deep Extubation/Placebo|"Deep extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196012|NCT02162433|BG004|Baseline|Total|Total of all reporting groups
11196013|NCT02162433|FG000|Participant Flow|1. Awake Extubation/Dexmedetomidine|"Awake extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196014|NCT02162433|FG001|Participant Flow|2. Awake Extubation/Placebo|"Awake extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196015|NCT02162433|FG002|Participant Flow|3.Deep Extubation/Dexmedetomidine|"Deep extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
10795679|NCT00336973|BG000|Baseline|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
10795680|NCT00336973|FG000|Participant Flow|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
10795681|NCT00336973|OG000|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
10803035|NCT03615066|BG002|Baseline|Placebo + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803036|NCT03615066|BG003|Baseline|Total|Total of all reporting groups
10803037|NCT03615066|FG000|Participant Flow|Selgantolimod 3 mg + TAF|Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the tenofovir alafenamide (TAF) 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.
11196016|NCT02162433|FG003|Participant Flow|4. Deep Extubation/Placebo|"Deep extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196017|NCT02162433|OG000|Outcome|1. Awake Extubation/Dexmedetomidine|"Awake extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196018|NCT02162433|OG001|Outcome|2. Awake Extubation/Placebo|"Awake extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196019|NCT02162433|OG002|Outcome|3.Deep Extubation/Dexmedetomidine|"Deep extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196020|NCT02162433|OG003|Outcome|4. Deep Extubation/Placebo|"Deep extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196021|NCT02162433|EG000|Reported Event|1. Awake Extubation/Dexmedetomidine|"Awake extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196022|NCT02162433|EG001|Reported Event|2. Awake Extubation/Placebo|"Awake extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11196023|NCT02162433|EG002|Reported Event|3.Deep Extubation/Dexmedetomidine|"Deep extubation receiving dexmedetomidine.~Dexmedetomidine: to arms 1,3"
11196024|NCT02162433|EG003|Reported Event|4. Deep Extubation/Placebo|"Deep extubation receiving placebo (normal saline).~Normal Saline: to arms 2,4. Serves as the placebo."
11202250|NCT02206607|EG004|Reported Event|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
10795682|NCT00326183|BG000|Baseline|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
10795683|NCT00326183|BG001|Baseline|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
10795684|NCT00326183|BG002|Baseline|Total|Total of all reporting groups
10795685|NCT00326183|FG000|Participant Flow|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
10795686|NCT00326183|FG001|Participant Flow|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
10795687|NCT00326183|OG000|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
10795688|NCT00326183|OG001|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
10795689|NCT00323037|BG000|Baseline|Coreg Immediate Release|
10795690|NCT00323037|BG001|Baseline|Coreg Controlled Release|
10795691|NCT00323037|BG002|Baseline|Total|Total of all reporting groups
10795692|NCT00323037|FG000|Participant Flow|Coreg Immediate Release|
10795693|NCT00323037|FG001|Participant Flow|Coreg Controlled Release|
11196025|NCT02162446|BG000|Baseline|All Participants|Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
11196026|NCT02162446|FG000|Participant Flow|All Participants|Participants received a single dose of the OPS202 peptide (15 [± 5] microgram (μg) on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 megabecquerel (MBq) (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to three dimensional (3D) positron emission tomography/computed tomography (PET/CT) scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
10795694|NCT00323037|OG000|Outcome|Coreg Immediate Release|
10795695|NCT00323037|OG001|Outcome|Coreg Controlled Release|
10795696|NCT00318656|BG000|Baseline|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
10795697|NCT00318656|BG001|Baseline|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
10795698|NCT00318656|BG002|Baseline|Total|Total of all reporting groups
10795699|NCT00318656|FG000|Participant Flow|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
10795700|NCT00318656|FG001|Participant Flow|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
10795701|NCT00318656|OG000|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
10795702|NCT00318656|OG001|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
10795703|NCT00301262|BG000|Baseline|Start : DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
10795704|NCT00301262|BG001|Baseline|Start : DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
10795705|NCT00301262|BG002|Baseline|Total|Total of all reporting groups
10795706|NCT00301262|FG000|Participant Flow|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
10795707|NCT00301262|FG001|Participant Flow|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
10795708|NCT00301262|OG000|Outcome|DB Viagra|
10795709|NCT00301262|OG001|Outcome|DB Placebo|
10795710|NCT00301262|OG000|Outcome|DB Viagra Week 8|
10795711|NCT00301262|OG001|Outcome|DB Viagra/OL Viagra Week 14|
10795712|NCT00301262|OG002|Outcome|DB Placebo Week 8|
10795713|NCT00301262|OG003|Outcome|DB Placebo/OL Viagra Week 14|
10795714|NCT00301262|OG001|Outcome|DB Viagra /OL Viagra Week 14|
10795715|NCT00301262|OG000|Outcome|Week 8 DB Viagra|
10795716|NCT00301262|OG001|Outcome|Week 8 DB Placebo|
10795717|NCT00301262|OG002|Outcome|Week 14 DB Viagra/OL Viagra|
10795718|NCT00301262|OG003|Outcome|Week 14 DB Placebo/OL Viagra|
10795719|NCT00301262|OG000|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
10795720|NCT00301262|OG001|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
10795721|NCT00301262|OG000|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
10795722|NCT00301262|OG001|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
10795723|NCT00301262|OG000|Outcome|DB Viagra / OL Viagra|
10795724|NCT00301262|OG001|Outcome|DB Placebo/ OL Viagra|
10795725|NCT00301262|OG001|Outcome|DB Placebo / OL Viagra|
10795726|NCT00301262|OG000|Outcome|DB Viagra Baseline < Week 8|
10795727|NCT00301262|OG001|Outcome|DB Placebo Baseline to < Week 8|
10795728|NCT00301262|OG002|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
10795729|NCT00301262|OG003|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
10795730|NCT00301262|OG001|Outcome|DB Placebo Baseline < Week 8|
10795731|NCT00283868|BG000|Baseline|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
10795732|NCT00283868|BG001|Baseline|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
10795733|NCT00283868|BG002|Baseline|Total|Total of all reporting groups
10795734|NCT00283868|FG000|Participant Flow|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
10795735|NCT00283868|FG001|Participant Flow|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
10795736|NCT00283868|OG000|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
10795737|NCT00283868|OG001|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
10795738|NCT00282867|BG000|Baseline|Tight Control Group|target glucose level 70-110 mg/dL
10795739|NCT00282867|BG001|Baseline|Loose Control Group|target glucose level 70 - 200 mg/dL
10795740|NCT00282867|BG002|Baseline|Usual Care Group|target level 70 - 300 mg/dL
10795741|NCT00282867|BG003|Baseline|Total|Total of all reporting groups
10795742|NCT00282867|FG000|Participant Flow|Tight Control Group|target glucose level 70-110 mg/dL
10795743|NCT00282867|FG001|Participant Flow|Loose Control Group|target glucose level 70 - 200 mg/dL
10795744|NCT00282867|FG002|Participant Flow|Usual Care Group|target level 70 - 300 mg/dL
10795745|NCT00282867|OG000|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
10795746|NCT00282867|OG001|Outcome|Loose Control Group|target glucose level 70 - 200 mg/dL
10795747|NCT00282867|OG002|Outcome|Usual Care Group|target level 70 - 300 mg/dL
10795748|NCT00275340|BG000|Baseline|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
10795749|NCT00275340|BG001|Baseline|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
10795750|NCT00275340|BG002|Baseline|Total|Total of all reporting groups
10795751|NCT00275340|FG000|Participant Flow|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
10795752|NCT00275340|FG001|Participant Flow|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
10795753|NCT00275340|OG000|Outcome|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
10795754|NCT00275340|OG001|Outcome|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
10795755|NCT00271544|BG000|Baseline|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
10795756|NCT00271544|FG000|Participant Flow|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
10795757|NCT00271544|OG000|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
10795758|NCT00271544|OG000|Outcome|4196 Lead|Subjects who underwent Model 4196 LV lead implant attempt
10795759|NCT00271544|OG000|Outcome|4196 Lead|Subjects with tip electrode threshold capture at 0.5ms at 1-month
10795760|NCT00271544|OG000|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month
10795761|NCT00271544|OG000|Outcome|4196 Lead|Subjects who underwent an implant attempt with successful CS cannulation
10795762|NCT00271544|OG000|Outcome|4196 Lead|Subjects who underwent an implant attempt
10795763|NCT00271544|OG000|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
10795764|NCT00271544|OG000|Outcome|4196 Lead|Subjects with tip electrode R-wave amplitude at 12-month
10795765|NCT00271544|OG000|Outcome|4196 Lead|Subjects with tip electrode threshold captured at 0.5ms at 12-month
10795766|NCT00271544|OG000|Outcome|4196 Lead|Subjects with tip electrode pacing impedance at 12-month
10795767|NCT00271544|OG000|Outcome|4196 Lead|Subjects with ring electrode R-wave amplitude at implant
10795768|NCT00271544|OG000|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 12-month
10795769|NCT00271544|OG000|Outcome|4196 Lead|Subjects with ring electrode pacing impedance at 12-month
10795770|NCT00271544|OG000|Outcome|4196 Lead|All enrolled subjects
10803038|NCT03615066|FG001|Participant Flow|Selgantolimod 1.5 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803039|NCT03615066|FG002|Participant Flow|Placebo + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
11196027|NCT02162446|OG000|Outcome|All Participants|Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
10803040|NCT03615066|OG000|Outcome|Selgantolimod 3 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803041|NCT03615066|OG001|Outcome|Selgantolimod 1.5 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803042|NCT03615066|OG002|Outcome|Placebo + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803043|NCT03615066|OG001|Outcome|Selgantolimod 1.5 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 doses. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803044|NCT03615066|OG000|Outcome|Selgantolimod 3 mg + TAF: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803045|NCT03615066|OG001|Outcome|Selgantolimod 1.5 mg + TAF: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10795771|NCT00240500|BG000|Baseline|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795772|NCT00240500|BG001|Baseline|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795773|NCT00240500|BG002|Baseline|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795774|NCT00240500|BG003|Baseline|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795775|NCT00240500|BG004|Baseline|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795776|NCT00240500|BG005|Baseline|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795777|NCT00240500|BG006|Baseline|Total|Total of all reporting groups
10795778|NCT00240500|FG000|Participant Flow|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795779|NCT00240500|FG001|Participant Flow|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795780|NCT00240500|FG002|Participant Flow|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795781|NCT00240500|FG003|Participant Flow|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795782|NCT00240500|FG004|Participant Flow|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795783|NCT00240500|FG005|Participant Flow|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795784|NCT00240500|OG000|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795785|NCT00240500|OG001|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795786|NCT00240500|OG002|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795787|NCT00240500|OG003|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795788|NCT00240500|OG004|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
10795789|NCT00240500|OG005|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
10795790|NCT00235326|BG000|Baseline|Unexposed to Gastroenteritis|
10795791|NCT00235326|BG001|Baseline|Exposed to Gastroenteritis|
10795792|NCT00235326|BG002|Baseline|Total|Total of all reporting groups
10795793|NCT00235326|FG000|Participant Flow|Unexposed to Gastroenteritis|
10795794|NCT00235326|FG001|Participant Flow|Exposed to Gastroenteritis|
10795795|NCT00235326|OG000|Outcome|Unexposed to Gastroenteritis|
10795796|NCT00235326|OG001|Outcome|Exposed to Gastroenteritis|
11196028|NCT02162446|OG000|Outcome|ITT Population (Pre-dose)|Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.
10795797|NCT00232141|BG000|Baseline|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
10795798|NCT00232141|BG001|Baseline|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
10795799|NCT00232141|BG002|Baseline|Total|Total of all reporting groups
10795800|NCT00232141|FG000|Participant Flow|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
10795801|NCT00232141|FG001|Participant Flow|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
10795802|NCT00232141|OG000|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
11196029|NCT02162446|OG001|Outcome|ITT Population (Day 0)|Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
10795803|NCT00232141|OG001|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
10795804|NCT00231153|BG000|Baseline|Omiganan 1% Gel|
10795805|NCT00231153|BG001|Baseline|Povidone-Iodine|
10795806|NCT00231153|BG002|Baseline|Total|Total of all reporting groups
10795807|NCT00231153|FG000|Participant Flow|Omiganan 1% Gel|"All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
10795808|NCT00231153|FG001|Participant Flow|Povidone-Iodine|"All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
10795809|NCT00231153|OG000|Outcome|Omiganan 1% Gel|
10795810|NCT00231153|OG001|Outcome|Povidone-Iodine|
10795811|NCT00224003|BG000|Baseline|Sodium Ferric Gluconate Complex|
10795812|NCT00224003|FG000|Participant Flow|Sodium Ferric Gluconate Complex|
10795813|NCT00224003|OG000|Outcome|Sodium Ferric Gluconate Complex|
10795814|NCT00162942|BG000|Baseline|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
10795815|NCT00162942|BG001|Baseline|Sham|Sham, ten apheresis sessions within 9 weeks
10795816|NCT00162942|BG002|Baseline|Total|Total of all reporting groups
10795817|NCT00162942|FG000|Participant Flow|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
10795818|NCT00162942|FG001|Participant Flow|Sham|Sham, ten apheresis sessions within 9 weeks
10795819|NCT00162942|OG000|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
10795820|NCT00162942|OG001|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
10795821|NCT00147290|BG000|Baseline|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
10795822|NCT00147290|BG001|Baseline|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
10795823|NCT00147290|BG002|Baseline|Total|Total of all reporting groups
10795824|NCT00147290|FG000|Participant Flow|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
10795825|NCT00147290|FG001|Participant Flow|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
10795826|NCT00147290|OG000|Outcome|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
10795827|NCT00147290|OG001|Outcome|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
11196030|NCT02162446|OG002|Outcome|ITT Population (Day 21)|Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
10795828|NCT00147277|BG000|Baseline|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
10795829|NCT00147277|BG001|Baseline|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
11196031|NCT02162446|OG000|Outcome|ITT Population (Day 0)|Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
10795830|NCT00147277|BG002|Baseline|Total|Total of all reporting groups
10795831|NCT00147277|FG000|Participant Flow|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
10795832|NCT00147277|FG001|Participant Flow|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
10795833|NCT00147277|OG000|Outcome|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
10795834|NCT00147277|OG001|Outcome|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
10795835|NCT00126776|BG000|Baseline|Disease Management for COPD|disease management for COPD
10795836|NCT00126776|BG001|Baseline|Usual Care|usual care
10795837|NCT00126776|BG002|Baseline|Total|Total of all reporting groups
10795838|NCT00126776|FG000|Participant Flow|Disease Management for COPD|disease management for COPD
10795839|NCT00126776|FG001|Participant Flow|Usual Care|usual care
10795840|NCT00126776|OG000|Outcome|Disease Management for COPD|disease management for COPD
10795841|NCT00126776|OG001|Outcome|Usual Care|usual care
10795842|NCT00120042|BG000|Baseline|1|No specific oxytocic to assist in placental delivery
10795843|NCT00120042|BG001|Baseline|2|Intramuscular oxytocin injection
10795844|NCT00120042|BG002|Baseline|3|Oral misoprostol to assist in placental delivery
10795845|NCT00120042|BG003|Baseline|Total|Total of all reporting groups
10795846|NCT00120042|FG000|Participant Flow|1|No specific oxytocic to assist in placental delivery
10795847|NCT00120042|FG001|Participant Flow|2|Intramuscular oxytocin injection
10795848|NCT00120042|FG002|Participant Flow|3|Oral misoprostol to assist in placental delivery
10795849|NCT00120042|OG000|Outcome|1|No specific oxytocic to assist in placental delivery
10795850|NCT00120042|OG001|Outcome|2|Intramuscular oxytocin injection
10795851|NCT00120042|OG002|Outcome|3|Oral misoprostol to assist in placental delivery
10795852|NCT00106626|BG000|Baseline|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
10795853|NCT00106626|BG001|Baseline|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
10795854|NCT00106626|BG002|Baseline|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
10795855|NCT00106626|BG003|Baseline|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
10795856|NCT00106626|BG004|Baseline|Total|Total of all reporting groups
10795857|NCT00106626|FG000|Participant Flow|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
10795858|NCT00106626|FG001|Participant Flow|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
10795859|NCT00106626|FG002|Participant Flow|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
10795860|NCT00106626|FG003|Participant Flow|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
10795861|NCT00106626|OG000|Outcome|Dose Level A.1|(Cohort A) Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
10795862|NCT00106626|OG001|Outcome|Dose Level A.2|(Cohort A) Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin
10795863|NCT00106626|OG002|Outcome|Dose Level B.1|(Cohort B) Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
10795864|NCT00106626|OG003|Outcome|Dose Level B.2|(Cohort B) Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
10795865|NCT00106626|OG004|Outcome|Dose Level C.1|(Cohort C) Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
10795866|NCT00106626|OG005|Outcome|Dose Level C.2|(Cohort C) Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
10795867|NCT00106626|OG006|Outcome|Dose Level C.3|(Cohort C) Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed
10795868|NCT00106626|OG007|Outcome|Dose Level D.1|(Cohort D) Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
10795869|NCT00106626|OG008|Outcome|Dose Level D.2|(Cohort D) Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed
10795870|NCT00106626|OG000|Outcome|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
10795871|NCT00106626|OG001|Outcome|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
10795872|NCT00106626|OG002|Outcome|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
10795873|NCT00106626|OG003|Outcome|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
10803046|NCT03615066|OG002|Outcome|Placebo + TAF: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803047|NCT03615066|EG000|Reported Event|Selgantolimod 3 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803048|NCT03615066|EG001|Reported Event|Selgantolimod 1.5 mg + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10795874|NCT00089141|BG000|Baseline|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
10795875|NCT00089141|BG001|Baseline|Placebo|Patients receive oral placebo twice daily
10795876|NCT00089141|BG002|Baseline|Total|Total of all reporting groups
10795877|NCT00089141|FG000|Participant Flow|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
10795878|NCT00089141|FG001|Participant Flow|Placebo|Patients receive oral placebo twice daily
10795879|NCT00089141|OG000|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
10795880|NCT00089141|OG001|Outcome|Placebo|Patients receive oral placebo twice daily
10795881|NCT00083759|BG000|Baseline|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
10795882|NCT00083759|BG001|Baseline|Placebo|Placebo IV infusions + methotrexate (MTX)
10795883|NCT00083759|BG002|Baseline|Total|Total of all reporting groups
10795884|NCT00083759|FG000|Participant Flow|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
10795885|NCT00083759|FG001|Participant Flow|Placebo|Placebo IV infusions + methotrexate (MTX)
10795886|NCT00083759|OG000|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
10795887|NCT00083759|OG001|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
10795888|NCT03513068|BG000|Baseline|Standard Of Care (SOC)|Standard of care long-term oxygen therapy
10795889|NCT03513068|BG001|Baseline|SOC + POC (Portable Oxygen Concentrator)|"Standard of care long-term oxygen therapy + POC~Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)"
10795890|NCT03513068|BG002|Baseline|Total|Total of all reporting groups
10795891|NCT03513068|FG000|Participant Flow|Standard Of Care (SOC)|Standard of care long-term oxygen therapy
11196032|NCT02162446|OG001|Outcome|ITT Population (Day 21)|Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
10795892|NCT03513068|FG001|Participant Flow|SOC + POC (Portable Oxygen Concentrator)|"Standard of care long-term oxygen therapy + POC~Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)"
11196033|NCT02162446|EG000|Reported Event|All Participants|Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
10795893|NCT03513068|OG000|Outcome|Standard Of Care (SOC)|Standard of care long-term oxygen therapy
10795894|NCT03513068|OG001|Outcome|SOC + POC (Portable Oxygen Concentrator)|"Standard of care long-term oxygen therapy + POC~Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)"
10795895|NCT03513068|EG000|Reported Event|Standard Of Care (SOC)|Standard of care long-term oxygen therapy
10795896|NCT03513068|EG001|Reported Event|SOC + POC (Portable Oxygen Concentrator)|"Standard of care long-term oxygen therapy + POC~Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)"
10795897|NCT03507127|BG000|Baseline|Varenicline|Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
10795898|NCT03507127|BG001|Baseline|Placebo|Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
10795899|NCT03507127|BG002|Baseline|Total|Total of all reporting groups
10795900|NCT03507127|FG000|Participant Flow|Varenicline|Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
10795901|NCT03507127|FG001|Participant Flow|Placebo|Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
10795902|NCT03507127|OG000|Outcome|Varenicline|Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
10795903|NCT03507127|OG001|Outcome|Placebo|Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
10795904|NCT03507127|EG000|Reported Event|Varenicline|Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
10795905|NCT03507127|EG001|Reported Event|Placebo|Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
10795906|NCT03502811|BG000|Baseline|MitraClip NTR/XTR System|Percutaneous mitral valve repair using the MitraClip NTR and XTR system
10795907|NCT03502811|FG000|Participant Flow|MitraClip NTR/XTR System|Percutaneous mitral valve repair using the MitraClip NTR and XTR system
10795908|NCT03502811|OG000|Outcome|MitraClip NTR/XTR System|Percutaneous mitral valve repair using the MitraClip NTR and XTR system
10795909|NCT03502811|EG000|Reported Event|MitraClip NTR/XTR System|Percutaneous mitral valve repair using the MitraClip NTR and XTR system
10795910|NCT04789382|BG000|Baseline|Sequence 1|LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
10795911|NCT04789382|BG001|Baseline|Sequence 2|Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
10795912|NCT04789382|BG002|Baseline|Sequence 3|LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.
10795913|NCT04789382|BG003|Baseline|Sequence 4|PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.
10795914|NCT04789382|BG004|Baseline|Total|Total of all reporting groups
10795915|NCT04789382|FG000|Participant Flow|Sequence 1|LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
10795916|NCT04789382|FG001|Participant Flow|Sequence 2|Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was be 2 hours.
10795917|NCT04789382|FG002|Participant Flow|Sequence 3|LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.
10795918|NCT04789382|FG003|Participant Flow|Sequence 4|PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.
10795919|NCT04789382|OG000|Outcome|LID018869+RepleniSH|LID018869+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
10795920|NCT04789382|OG001|Outcome|Biofinity+RepleniSH|Biofinity+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
10795921|NCT04789382|OG002|Outcome|LID018869+Biotrue|LID018869+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
10795922|NCT04789382|OG003|Outcome|PV+Biotrue|PV+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
10795923|NCT04789382|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
10795924|NCT04789382|EG001|Reported Event|LID018869+RepleniSH Ocular|Events reported in this group occurred while exposed to the study contact lenses
10795925|NCT04789382|EG002|Reported Event|Biofinity+RepleniSH Ocular|Events reported in this group occurred while exposed to the study contact lenses
10795926|NCT04789382|EG003|Reported Event|LID018869+Biotrue Ocular|Events reported in this group occurred while exposed to the study contact lenses
10795927|NCT04789382|EG004|Reported Event|PV+Biotrue Ocular|Events reported in this group occurred while exposed to the study contact lenses
10795928|NCT04789382|EG005|Reported Event|All Nonocular|Events reported in this group occurred while left and right eyes were exposed to different study lenses as per randomized regimen sequence
10803049|NCT03615066|EG002|Reported Event|Placebo + TAF|Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
10803050|NCT03557931|BG000|Baseline|Placebo|Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
10803051|NCT03557931|BG001|Baseline|ASP4345 50 mg|Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
10803052|NCT03557931|BG002|Baseline|ASP4345 150 mg|Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
10803053|NCT03557931|BG003|Baseline|Total|Total of all reporting groups
10803054|NCT03557931|FG000|Participant Flow|Placebo|Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
10803055|NCT03557931|FG001|Participant Flow|ASP4345 50 Milligrams (mg)|Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
10803056|NCT03557931|FG002|Participant Flow|ASP4345 150 mg|Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
10803057|NCT03557931|OG000|Outcome|Placebo|Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
10803058|NCT03557931|OG001|Outcome|ASP4345 50 mg|Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
10803059|NCT03557931|OG002|Outcome|ASP4345 150 mg|Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
10803060|NCT03557931|OG000|Outcome|ASP4345 50 mg|Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
10803061|NCT03557931|OG001|Outcome|ASP4345 150 mg|Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
10803062|NCT03557931|EG000|Reported Event|Placebo|Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
10803063|NCT03557931|EG001|Reported Event|ASP4345 50 mg|Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
10803064|NCT03557931|EG002|Reported Event|ASP4345 150 mg|Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
10803065|NCT03251144|BG000|Baseline|TAF Based ART|HIV infected persons who receive TAF based ART
10803066|NCT03251144|BG001|Baseline|TDF Based ART|HIV infected persons who receive TDF based ART
10803067|NCT03251144|BG002|Baseline|Total|Total of all reporting groups
10803068|NCT03251144|FG000|Participant Flow|TAF Based ART|HIV infected persons who receive TAF based ART
10803069|NCT03251144|FG001|Participant Flow|TDF Based ART|HIV infected persons who receive TDF based ART
10803070|NCT03251144|OG000|Outcome|TAF Based ART|HIV infected persons who receive TAF based ART
10795929|NCT04428333|BG000|Baseline|Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795930|NCT04428333|BG001|Baseline|Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795931|NCT04428333|BG002|Baseline|Total|Total of all reporting groups
10795932|NCT04428333|FG000|Participant Flow|Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795933|NCT04428333|FG001|Participant Flow|Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795934|NCT04428333|OG000|Outcome|Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795935|NCT04428333|OG001|Outcome|Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795936|NCT04428333|EG000|Reported Event|Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795937|NCT04428333|EG001|Reported Event|Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy|Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.
10795938|NCT03530995|BG000|Baseline|All Subjects Part 1: KD025 QD Dosing|Period 1: 200 mg KD025 QD alone; Period 2: 200 mg KD025 QD with Itraconazole; Period 3: 200 mg KD025 QD with Rabeprazole; Period 4: 200 mg KD025 QD with Rifampicin
10795939|NCT03530995|BG001|Baseline|All Subjects in Part 2: KD025 BID Dosing|Period 1: 200 mg KD025 BID alone; Period 2: 200 mg KD025 BID with Omeprazole
11337838|NCT03595280|FG001|Participant Flow|Untailored Messages|"Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
10795940|NCT03530995|BG002|Baseline|Total|Total of all reporting groups
10795941|NCT03530995|FG000|Participant Flow|Part 1 Belumosudil (KD025) QD Dosing|Subjects received a single dose of belumosudil 200 mg on 4 separate occasions, and multiple single doses of itraconazole, rabeprazole and rifampicin, on separate occasions, for 9,4 and 9 consecutive days, respectively.
10795942|NCT03530995|FG001|Participant Flow|Part 2 Belumosudil (KD025) BID Dosing|Subjects received a twice daily dose of belumosudil 200 mg on 2 separate occasions, and single doses of omeprazole for 4 consecutive days.
10795943|NCT03530995|OG000|Outcome|Part 1, Period 1: Belumosudil Alone|Belumosudil 200 mg single dose on Day 1
10795944|NCT03530995|OG001|Outcome|Part 1, Period 2: Belumosudil + Itraconazole|Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
10795945|NCT03530995|OG002|Outcome|Part 1, Period 3: Belumosudil + Rabeprazole|Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
10795946|NCT03530995|OG003|Outcome|Part 1, Period 4: Belumosudil + Rifampicin|Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
10795947|NCT03530995|OG001|Outcome|Part 1, Period 4: Belumosudil + Rifampicin|Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
10795948|NCT03530995|OG000|Outcome|Part 2, Period 1: Belumosudil Alone|Belumosudil 200 mg BID (Q12h) on Day 1
10795949|NCT03530995|OG001|Outcome|Part 2, Period 2: Belumosudil + Omeprazole|Omeprazole 20 mg QD fasted for 3 days (Period 2 Days -3 to -1), Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
10795950|NCT03530995|OG001|Outcome|Part 1, Period 2: Belumosudil + Itraconazole|Itraconazole 200 mg QD on Day 1-7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
10795951|NCT03530995|OG002|Outcome|Part 1, Period 3: Belumosudil + Rabeprazole|Rabeprazole 20 mg BID on Day 1-3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4.
10795952|NCT03530995|OG003|Outcome|Part 1, Period 4: Belumosudil + Rifampicin|Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10
10795953|NCT03530995|OG004|Outcome|Part 2, Period 1: Belumosudil Only|Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
10795954|NCT03530995|OG005|Outcome|Part 2, Period 2: Belumosudil + Omeprazole|Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
10795955|NCT03530995|OG002|Outcome|Part 2, Period 1: Belumosudil Alone|Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
10795956|NCT03530995|OG003|Outcome|Part 2, Period 2: Belumosudil + Omeprazole|Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
10795957|NCT03530995|EG000|Reported Event|Part 1, Period 1: Belumosudil Only|Belumosudil 200 mg single dose on Day 1
10795958|NCT03530995|EG001|Reported Event|Part 1, Period 2: Belumosudil + Itraconazole|Itraconazole 200 mg QD Day 1-7, Belumosudil 200 mg QD with itraconazole on Day 8, Itraconazole 200 mg QD on Day 9
10795959|NCT03530995|EG002|Reported Event|Part 1, Period 3: Belumosudil +Rabeprazole|Rabeprazole 20 mg BID on Day 1-3, Belumosudil 200 mg + rabeprazole 20 mg QD on Day 4
10795960|NCT03530995|EG003|Reported Event|Part 1, Period 4: Belumosudil + Rifampicin|Rifampicin 600 mg QD on Day 1-9, Belumosudil 200 mg on Day 10
10795961|NCT03530995|EG004|Reported Event|Part 2, Period 1: Belumosudil Only|Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1: KD025 200 mg BID
10795962|NCT03530995|EG005|Reported Event|Part 2, Period 2: Belumosudil + Omeprazole|Omeprazole 20 mg QD fasted for 3 days (Period 2 Days -3 to -10, Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
10795963|NCT03373006|BG000|Baseline|Men With Gleason Score 7 Prostate Cancer|"Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.~Axumin PET/CT: Synthetic amino acid uptake agent injection followed by imaging"
10795964|NCT03373006|FG000|Participant Flow|Men With Gleason Score 7 Prostate Cancer|"Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.~Axumin PET/CT: Synthetic amino acid uptake agent injection followed by imaging"
10795965|NCT03373006|OG000|Outcome|Axumin Arm|Men over 45 years of age with Gleason 3+4 or 4+3 prostate cancer
10795966|NCT03373006|EG000|Reported Event|Men With Gleason Score 7 Prostate Cancer|"Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.~Axumin PET/CT: Synthetic amino acid uptake agent injection followed by imaging~No adverse events were observed."
10795967|NCT03368937|BG000|Baseline|Tandem t:Slim X2 With Control-IQ Technology|"Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.~Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission."
10795968|NCT03368937|FG000|Participant Flow|Tandem t:Slim X2 With Control-IQ Technology|"Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.~Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission."
10795969|NCT03368937|OG000|Outcome|Tandem t:Slim X2 With Control-IQ Technology|"Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.~Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission."
10795970|NCT03368937|EG000|Reported Event|Tandem t:Slim X2 With Control-IQ Technology|"Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.~Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission."
11196034|NCT02162576|BG000|Baseline|Propeller Health Intervention Group|All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months (see intervention for description).
11196035|NCT02162576|FG000|Participant Flow|Propeller Health Intervention Group|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
11202251|NCT02206620|BG000|Baseline|All Study Participants|Donepezil was taken for 3 weeks at 5mg/day (1 tablet/day) and then increased to 10mg/day (2 tablets/day) for another 3 weeks. The same was done for the placebo (1 tablet for the first 3 weeks, then 2 tablets for the following 3 weeks). There was a washout period of 6 weeks between the interventions. Participants were randomized to start with donepezil or placebo.
11202252|NCT02206620|FG000|Participant Flow|Donepezil, Then Placebo|Donepezil 5 mg per day for weeks 1-3. 10 mg/day for weeks 4-6. Then 6 week washout followed by 6 weeks of placebo. Placebo (identical appearing capsules), two capsules per day for 2 weeks and four capsules per day for the following 2 weeks.
10795971|NCT03204812|BG000|Baseline|Treatment (Tremelimumab, Durvalumab)|Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
10795972|NCT03204812|FG000|Participant Flow|Treatment (Tremelimumab, Durvalumab)|Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
10795973|NCT03204812|OG000|Outcome|Treatment (Tremelimumab, Durvalumab)|Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
10795974|NCT03204812|EG000|Reported Event|Treatment (Tremelimumab, Durvalumab)|Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.
10795975|NCT03199391|BG000|Baseline|BioWick SureLock Implant|This arm will include all subjects who are implanted with the BioWick SureLock Implant.
10795976|NCT03199391|FG000|Participant Flow|BioWick SureLock Implant|This arm included all subjects who were implanted with the BioWick SureLock Implant.
10795977|NCT03199391|OG000|Outcome|BioWick SureLock Implant|This arm will include all subjects who are implanted with the BioWick SureLock Implant.
10795978|NCT03199391|EG000|Reported Event|BioWick SureLock Implant|This arm will include all subjects who are implanted with the BioWick SureLock Implant.
10795979|NCT03084471|BG000|Baseline|Durvalumab|All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
10795980|NCT03084471|FG000|Participant Flow|Durvalumab|All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
10795981|NCT03084471|OG000|Outcome|AESI|AESIs are defined as AEs with a likely inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab and/or tremelimumab and requiring more frequent monitoring and/or interventions, such as corticosteroids, immunosuppressants, and/or endocrine therapy.
10795982|NCT03084471|OG001|Outcome|AEPI|AEPIs are defined as AEs that could have a potential inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab but are more likely to have occurred due to other pathophysiological mechanisms, thus, the likelihood of the event being inflammatory or immune-mediated in nature is not high and/or is most often or usually explained by the other causes.
10795983|NCT03084471|OG002|Outcome|imAE|The imAEs that occurred during this study were determined by a programmatic algorithm that required specific treatment for AESIs to be considered imAEs; the same specific treatment was required for AEPIs as well.
10795984|NCT03084471|OG000|Outcome|Durvalumab|All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
10795985|NCT03084471|EG000|Reported Event|Durvalumab|All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
10795986|NCT03072459|BG000|Baseline|Navio Robotic-assisted Surgical System|Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.
10795987|NCT03072459|FG000|Participant Flow|Navio Robotic-assisted Surgical System|Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.
10795988|NCT03072459|OG000|Outcome|Navio Robotic-assisted Surgical System|Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.
10795989|NCT03072459|EG000|Reported Event|Navio Robotic-assisted Surgical System|Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.
10795990|NCT03029234|BG000|Baseline|Carfilzomib With Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23.~Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first."
10795991|NCT03029234|FG000|Participant Flow|Carfilzomib With Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23.~Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first."
10795992|NCT03029234|OG000|Outcome|Carfilzomib With Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23.~Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first."
10795993|NCT03029234|EG000|Reported Event|Carfilzomib With Dexamethasone|"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23.~Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first."
10795994|NCT03019406|BG000|Baseline|Cohort 1: Avalglucosidase Alfa 20 mg/kg|Avalglucosidase alfa, 20 mg/kg IV infusion qow for 25 weeks in the PAP, followed by same treatment from Week 26 up to Week 371 in extension treatment period (ETP).
10795995|NCT03019406|BG001|Baseline|Cohort 2: Avalglucosidase Alfa 40 mg/kg|Avalglucosidase alfa 40 mg/kg IV infusion qow for 25 weeks in the PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10795996|NCT03019406|BG002|Baseline|Cohort 3a: Avalglucosidase Alfa 40 mg//kg|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received avalglucosidase alfa 40 mg/kg (the highest tolerated dose) IV infusion qow for 25 weeks in PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10795997|NCT03019406|BG003|Baseline|Cohort 3b: Alglucosidase Alfa in PAP|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received alglucosidase alfa at their current stable dose (defined as dose [between 20 mg/kg qow and 40 mg/kg weekly as per physician] administered regularly for a minimum of 6 months immediately prior to entry in this study) IV infusion for 25 weeks in PAP. After PAP, participants received avalglucosidase alfa 40mg/kg IV infusion qow from Week 26 up to Week 371 in ETP.
10795998|NCT03019406|BG004|Baseline|Total|Total of all reporting groups
10795999|NCT03019406|FG000|Participant Flow|Cohort 1: Avalglucosidase Alfa 20 mg/kg|Avalglucosidase alfa, 20 mg/kg intravenous (IV) infusion qow for 25 weeks in the Primary Analysis Period (PAP), followed by same treatment from Week 26 up to Week 371 in extension treatment period (ETP).
10796000|NCT03019406|FG001|Participant Flow|Cohort 2: Avalglucosidase Alfa 40 mg/kg|Avalglucosidase alfa 40 mg/kg IV infusion qow for 25 weeks in the PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10803071|NCT03251144|OG001|Outcome|TDF Based ART|HIV infected persons who receive TDF based ART
10803072|NCT03251144|EG000|Reported Event|TAF Based ART|HIV infected persons who receive TAF based ART
10796001|NCT03019406|FG002|Participant Flow|Cohort 3a: Avalglucosidase Alfa 40 mg//kg|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received avalglucosidase alfa 40 mg/kg (the highest tolerated dose) IV infusion qow for 25 weeks in PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10796002|NCT03019406|FG003|Participant Flow|Cohort 3b: Alglucosidase Alfa in PAP|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received alglucosidase alfa at their current stable dose (defined as dose [between 20 mg/kg qow and 40 mg/kg weekly as per physician] administered regularly for a minimum of 6 months immediately prior to entry in this study) IV infusion for 25 weeks in PAP. After PAP, participants received avalglucosidase alfa 40mg/kg IV infusion qow from Week 26 up to Week 371 in ETP.
10796003|NCT03019406|OG000|Outcome|PAP: Cohort 1: Avalglucosidase Alfa 20 mg/kg|Avalglucosidase alfa 20 mg/kg IV infusion qow for 25 weeks in PAP.
10796004|NCT03019406|OG001|Outcome|PAP: Cohort 2: Avalglucosidase Alfa 40 mg/kg|Avalglucosidase alfa 40 mg/kg IV infusion qow for 25 weeks in PAP.
10796005|NCT03019406|OG002|Outcome|PAP: Cohort 3a: Avalglucosidase Alfa 40 mg/kg|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received avalglucosidase alfa 40 mg/kg (the highest tolerated dose) IV infusion qow for 25 weeks in PAP.
10796006|NCT03019406|OG003|Outcome|PAP: Cohort 3b: Alglucosidase Alfa|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received alglucosidase alfa at their current stable dose (defined as dose [between 20 mg/kg qow and 40 mg/kg weekly as per physician] administered regularly for a minimum of 6 months immediately prior to entry in this study) IV infusion for 25 weeks in PAP.
10796007|NCT03019406|EG000|Reported Event|PAP: Cohort 1: Avalglucosidase Alfa 20 mg/kg|Avalglucosidase alfa 20 mg/kg IV infusion qow for 25 weeks in PAP.
10796008|NCT03019406|EG001|Reported Event|PAP: Cohort 2: Avalglucosidase Alfa 40 mg/kg|Avalglucosidase alfa 40 mg/kg IV infusion qow for 25 weeks in PAP.
10796009|NCT03019406|EG002|Reported Event|PAP: Cohort 3a: Avalglucosidase Alfa 40 mg/kg|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received avalglucosidase alfa 40 mg/kg (the highest tolerated dose) IV infusion qow for 25 weeks in PAP.
10796010|NCT03019406|EG003|Reported Event|PAP: Cohort 3b: Alglucosidase Alfa|After determination of the highest tolerated avalglucosidase alfa dose in Cohort 1 and Cohort 2 (after at least 5 participants in each Cohort 1 and Cohort 2 had received the 7th dose of avalglucosidase alfa or completed Week 13 with a minimum of 6 infusions), participants received alglucosidase alfa at their current stable dose (defined as dose [between 20 mg/kg qow and 40 mg/kg weekly as per physician] administered regularly for a minimum of 6 months immediately prior to entry in this study) IV infusion for 25 weeks in PAP.
10796011|NCT03019406|EG004|Reported Event|ETP: Avalglucosidase Alfa 20 mg/kg|Included all participants of Cohort 1 who received avalglucosidase alfa 20 mg/kg IV infusion qow for 25 weeks in PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10796012|NCT03019406|EG005|Reported Event|Pooled Arm ETP: Avalglucosidase Alfa 40 mg/kg|Pooled arm included all participants of Cohorts 2 and 3a who received avalglucosidase alfa 40 mg/kg IV infusion qow for 25 weeks in PAP, followed by same treatment from Week 26 up to Week 371 in ETP.
10796013|NCT03019406|EG006|Reported Event|Alglucosidase Alfa in PAP Then Avalglucosidase Alfa 40 mg/kg in ETP|Included all participants of Cohort 3b who received alglucosidase alfa at their current stable dose (defined as dose [between 20 mg/kg qow and 40 mg/kg weekly as per physician] administered regularly for a minimum of 6 months immediately prior to entry in this study) IV infusion for 25 weeks in the PAP and after PAP, switched to receive avalglucosidase alfa 40 mg/kg IV infusion qow from Week 26 up to Week 371 in ETP.
10796014|NCT02874144|BG000|Baseline|AZD + INCS|AZD1981 40 mg 3 times a day orally, added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks.
10796015|NCT02874144|BG001|Baseline|PLACEBO + INCS|Placebo 3 times a day orally added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks.
10796016|NCT02874144|BG002|Baseline|Total|Total of all reporting groups
10796017|NCT02874144|FG000|Participant Flow|AZ Compound|"40 mg 12 weeks TID po~AZ compound: 40 mg three times daily po for 12 weeks~Collection of Biological Specimens: collection of biomarkers for analysis of nasal disease~Intranasal corticosteroid: QD Nasal Spray"
10796018|NCT02874144|FG001|Participant Flow|Placebo|"40 mg 12 weeks TID po~Collection of Biological Specimens: collection of biomarkers for analysis of nasal disease~Intranasal corticosteroid: QD Nasal Spray~Placebo: looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks"
10796019|NCT02874144|OG000|Outcome|AZD + INCS|AZD1981 40 mg three times a day , added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks.
10796020|NCT02874144|OG001|Outcome|PLACEBO + INCS|Matched Placebo (1:1 randomization) three times a day added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks.
10796021|NCT02874144|EG000|Reported Event|AZ+INCS|AZD1981 40 mg three times a day , added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks.
10796022|NCT02874144|EG001|Reported Event|Placebo + INCS|Matched Placebo (1:1 randomization) three times a day added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks
11202253|NCT02206620|FG001|Participant Flow|Placebo, Then Donepezil|Placebo (identical appearing capsules), two capsules per day for weeks 1-3 and four capsules per day for 4-6 weeks followed by washout for 6 weeks and then crossover to donepezil for six weeks. Donepezil 5 mg per day for 2 weeks, then 10 mg/day for the following 2 weeks.
10803073|NCT03251144|EG001|Reported Event|TDF Based ART|HIV infected persons who receive TDF based ART
10965773|NCT00883779|BG001|Baseline|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
10965774|NCT00883779|BG002|Baseline|Total|Total of all reporting groups
10965775|NCT00883779|FG000|Participant Flow|Placebo|Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
10965776|NCT00883779|FG001|Participant Flow|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
10965777|NCT00883779|OG000|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
10965778|NCT00883779|OG001|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
11196036|NCT02162576|OG000|Outcome|Propeller Health Intervention Group|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
11196037|NCT02162576|OG000|Outcome|Propeller Health Intervention|"All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months.~The Propeller sensor passively records inhaler actuations with a time stamp and location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via multiple platforms, providing an assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management (see intervention description for full details)."
11196038|NCT02162576|EG000|Reported Event|Propeller Health Intervention|"After the control period is completed at 1 month, all participants will continue using their sensors, and will begin to receive the full intervention for 12 months. The intervention includes access to all of the participant's sensor-collected data, trends, educational information and weekly reports. The 13-month term was chosen in order to eliminate any seasonal variation in asthma exacerbations.~Propeller Health: The digital sensor records rescue inhaler actuations, as well as time and date stamp, and location if available. Actuation data are then securely transmitted to Propeller Health where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. Each participant was invited to share reports with his or her healthcare provider, but this was not required."
11196039|NCT02162667|BG000|Baseline|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
11196040|NCT02162667|BG001|Baseline|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
11196041|NCT02162667|BG002|Baseline|Total|Total of all reporting groups
11196042|NCT02162667|FG000|Participant Flow|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
11196043|NCT02162667|FG001|Participant Flow|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
10803074|NCT02596035|BG000|Baseline|Clear Cell Histology|Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
11202254|NCT02206620|OG000|Outcome|Donepezil|"Donepezil 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.~Donepezil"
10803075|NCT02596035|BG001|Baseline|Non-Clear Cell Histology|Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803076|NCT02596035|BG002|Baseline|Brain Metastasis|Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803077|NCT02596035|BG003|Baseline|Total|Total of all reporting groups
10803078|NCT02596035|FG000|Participant Flow|Clear Cell Histology|Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803079|NCT02596035|FG001|Participant Flow|Non-Clear Cell Histology|Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803080|NCT02596035|FG002|Participant Flow|Brain Metastasis|Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803081|NCT02596035|OG000|Outcome|Clear Cell Histology|Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
11196044|NCT02162667|OG000|Outcome|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
11196045|NCT02162667|OG001|Outcome|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
10803082|NCT02596035|OG001|Outcome|Non-Clear Cell Histology|Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803083|NCT02596035|OG002|Outcome|Brain Metastasis|Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803084|NCT02596035|OG003|Outcome|Sarcomatoid|Participants with sarcomatoid feature defined by the presence of a distinct spindle-cell component occupying at least 1 microscopic low-power field (× 40) irrespective of clear cell histology, non-clear cell histology, and brain metastases were administered with nivolumab monotherapy at a dose of 240 mg Q2W by a 30-minute IV infusion.
10803085|NCT02596035|EG000|Reported Event|Nivolumab 240 mg|Participants received nivolumab 240 mg as a 30-minute intravenous (IV) infusion every 2 weeks.
10803086|NCT02576509|BG000|Baseline|Nivolumab 240 mg|Nivolumab 240 mg IV every 2 weeks until disease progression or unacceptable toxicity
10803087|NCT02576509|BG001|Baseline|Sorafenib 400 mg|Sorafenib 400 mg PO BID until disease progression or unacceptable toxicity
11196046|NCT02162667|OG000|Outcome|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.
10803088|NCT02576509|BG002|Baseline|Total|Total of all reporting groups
10803089|NCT02576509|FG000|Participant Flow|Nivolumab 240 mg|Nivolumab 240 mg IV every 2 weeks until disease progression or unacceptable toxicity
10803090|NCT02576509|FG001|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg PO BID until disease progression or unacceptable toxicity
10803091|NCT02576509|OG000|Outcome|Nivolumab 240 mg|Nivolumab 240 mg IV every 2 weeks until disease progression or unacceptable toxicity
10803092|NCT02576509|OG001|Outcome|Sorafenib 400 mg|Sorafenib 400 mg PO BID until disease progression or unacceptable toxicity
10803093|NCT02576509|EG000|Reported Event|NIVOLUMAB 240 mg|Nivolumab 240 mg IV every 2 weeks until disease progression or unacceptable toxicity
10803094|NCT02576509|EG001|Reported Event|SORAFENIB 400 mg|Sorafenib 400 mg PO BID until disease progression or unacceptable toxicity
10796044|NCT02611830|BG000|Baseline|Vedolizumab IV 300 mg, Induction Phase Only|Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.
10796045|NCT02611830|BG001|Baseline|Maintenance Phase: Induction IV + Placebo|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
10796046|NCT02611830|BG002|Baseline|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
10796047|NCT02611830|BG003|Baseline|Maintenance Phase: Induction IV + Vedolizumab 300 mg IV|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
10796048|NCT02611830|BG004|Baseline|Total|Total of all reporting groups
10796049|NCT02611830|FG000|Participant Flow|Open-Label Induction Phase: Vedolizumab 300 mg IV|Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.
10796050|NCT02611830|FG001|Participant Flow|Maintenance Phase: Induction IV + Placebo|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
10796051|NCT02611830|FG002|Participant Flow|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
10796052|NCT02611830|FG003|Participant Flow|Maintenance Phase: Induction IV + Vedolizumab 300 mg IV|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
10796053|NCT02611830|OG000|Outcome|Maintenance Phase: Induction IV + Placebo|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
10796054|NCT02611830|OG001|Outcome|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
11196047|NCT02162667|OG001|Outcome|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.
11202255|NCT02206620|OG001|Outcome|Placebo|"Placebo 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.~Donepezil"
10796055|NCT02611830|OG002|Outcome|Maintenance Phase: Induction IV + Vedolizumab 300 mg IV|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
10796056|NCT02611830|EG000|Reported Event|Vedolizumab IV 300 mg, Induction Phase Only|Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.
10796057|NCT02611830|EG001|Reported Event|Maintenance Phase: Induction IV + Placebo|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
10796058|NCT02611830|EG002|Reported Event|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
10796059|NCT02611830|EG003|Reported Event|Maintenance Phase: Induction IV + Vedolizumab 300 mg IV|Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
10796060|NCT02611817|BG000|Baseline|Induction Phase Only: Vedolizumab 300 mg IV|Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6.
11202256|NCT02206620|OG000|Outcome|Donepezil|Donepezil 5 mg per day for week 1-3. 10 mg/day for weeks 4-6. Then 6 week washout followed by 6 weeks of placebo.
11202257|NCT02206620|OG001|Outcome|Placebo|Placebo (identical appearing capsules), two capsules per day for week 1-3 and four capsules per day for 4-6 weeks followed by washout for 6 weeks and then crossover to donepezil for six weeks.
10796061|NCT02611817|BG001|Baseline|Maintenance Phase: Induction IV + Placebo|Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.
10796062|NCT02611817|BG002|Baseline|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
10796063|NCT02611817|BG003|Baseline|Total|Total of all reporting groups
10796064|NCT02611817|FG000|Participant Flow|Open-label Induction Phase: Vedolizumab 300 mg IV|Vedolizumab 300 milligram (mg), infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase.
10796065|NCT02611817|FG001|Participant Flow|Maintenance Phase: Induction IV + Placebo|Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.
10796066|NCT02611817|FG002|Participant Flow|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
10796067|NCT02611817|OG000|Outcome|Maintenance Phase: Induction IV + Placebo|Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.
10796068|NCT02611817|OG001|Outcome|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
10796069|NCT02611817|EG000|Reported Event|Induction Phase Only: Vedolizumab 300 mg IV|Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6.
10796070|NCT02611817|EG001|Reported Event|Maintenance Phase: Induction IV + Placebo|Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.
10796071|NCT02611817|EG002|Reported Event|Maintenance Phase: Induction IV + Vedolizumab 108 mg SC|Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
10796072|NCT02557139|BG000|Baseline|Cohort ABC|Period 1: Single-dose Belumosudil 200 mg tablet fasted (Regimen A); Washout; Period 2: Single-dose Belumosudil 200 mg tablet fed (Regimen B); Washout; Period 3: Single-dose Belumosudil two 100-mg capsules, i.e., 200 mg (Regimen C)
11202258|NCT02206620|EG000|Reported Event|Donepezil, Then Placebo (Phase I)|Participants took a donepezil 5mg tablet each day for 3 weeks, then increased the dose to 10mg (2 tablets each day) for 3 weeks. (This was followed by 6 weeks of a washout period and then taking the placebo in the same format -- 3 weeks of one tablet, followed by 3 weeks of 2 tablets to replicate the dosage increase.)
10796073|NCT02557139|BG001|Baseline|Cohort BCA|Period 1: Belumosudil 200 mg tablet fed; Washout; Period 2: Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 3: Belumosudil 200 mg tablet fasted
10796074|NCT02557139|BG002|Baseline|Cohort CAB|Period 1: Single-dose Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 2: Single-dose Belumosudil 200 mg tablet fasted; Washout; Period 3: Single-dose Belumosudil 200 mg tablet fed
10796075|NCT02557139|BG003|Baseline|Total|Total of all reporting groups
10796076|NCT02557139|FG000|Participant Flow|Cohort ABC|Period 1: Single-dose Belumosudil 200 mg tablet fasted (Regimen A); Washout; Period 2: Single-dose Belumosudil 200 mg tablet fed (Regimen B); Washout; Period 3: Single-dose Belumosudil two 100-mg capsules, i.e., 200 mg (Regimen C)
10796077|NCT02557139|FG001|Participant Flow|Cohort BCA|Period 1: Belumosudil 200 mg tablet fed; Washout; Period 2: Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 3: Belumosudil 200 mg tablet fasted
10796078|NCT02557139|FG002|Participant Flow|Cohort CAB|Period 1: Single-dose Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 2: Single-dose Belumosudil 200 mg tablet fasted; Washout; Period 3: Single-dose Belumosudil 200 mg tablet fed
10796079|NCT02557139|OG000|Outcome|Regimen A|Single-dose belumosudil 200 mg tablet in the fasting state
10796080|NCT02557139|OG001|Outcome|Regimen B|"Single-dose belumosudil 200 mg tablet in the fed state~Belumosudil Tablet"
10796081|NCT02557139|OG000|Outcome|Regimen B/Regimen A|Single-dose belumosudil 200 mg tablet fed (Regimen B) divided by single-dose belumosudil 200 mg tablet fasting (Regimen A)
10796082|NCT02557139|OG001|Outcome|Regimen B/Regimen C|Single-dose belumosudil 200 mg tablet fed (Regimen B) divided by single-dose belumosudil 200 mg capsule fed (Regimen C)
10796083|NCT02557139|OG000|Outcome|Regimen B/Regimen A|Single-dose belumosudil 200 mg tablet fed (Regimen B) divided by single-dose belumosudil 200 mg tablet fasted (Regimen A)
10796084|NCT02557139|OG002|Outcome|Regimen C|Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
10796085|NCT02557139|OG000|Outcome|Regimen A|Single-dose belumosudil 200 mg tablet in the fasted state
10796086|NCT02557139|OG001|Outcome|Regimen B|Single-dose belumosudil 200 mg tablet in the fed state
10796087|NCT02557139|OG002|Outcome|Regimen C|Single-dose belumosudil capsules (administered as two 100-mg capsules) in the fed state
10796088|NCT02557139|OG000|Outcome|Regimen A|"Single-dose belumosudil 200 mg tablet in the fasted state~Belumosudil Tablet"
10796089|NCT02557139|OG002|Outcome|Regimen C|"Single-dose belumosudil capsules (administered as two 100-mg capsules) in the fed state~Belumosudil Capsule"
10796090|NCT02557139|OG003|Outcome|Overall|Subjects who received Regimen A and/or Regimen B and/or Regimen C
10796091|NCT02557139|EG000|Reported Event|Regimen A|Single-dose belumosudil 200 mg tablet in the fasted state
10796092|NCT02557139|EG001|Reported Event|Regimen B|"Single-dose belumosudil 200 mg tablet in the fed state~Belumosudil Tablet"
10796093|NCT02557139|EG002|Reported Event|Regimen C|Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
10796094|NCT02488759|BG000|Baseline|Metastatic Monotherapy|Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796095|NCT02488759|BG001|Baseline|Metastatic Combo A|Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796096|NCT02488759|BG002|Baseline|Metastatic Combo B|Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796097|NCT02488759|BG003|Baseline|Metastatic Combo C|Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796098|NCT02488759|BG004|Baseline|Metastatic Combo D|Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796099|NCT02488759|BG005|Baseline|Neoadjuvant|Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
10796100|NCT02488759|BG006|Baseline|Total|Total of all reporting groups
10796101|NCT02488759|FG000|Participant Flow|Metastatic Monotherapy|Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796102|NCT02488759|FG001|Participant Flow|Metastatic Combo A|Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796103|NCT02488759|FG002|Participant Flow|Metastatic Combo B|Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796104|NCT02488759|FG003|Participant Flow|Metastatic Combo C|Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796105|NCT02488759|FG004|Participant Flow|Metastatic Combo D|Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796106|NCT02488759|FG005|Participant Flow|Neoadjuvant|Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
10796107|NCT02488759|OG000|Outcome|Neoadjuvant|Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
10796108|NCT02488759|OG000|Outcome|Metastatic Monotherapy|Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796109|NCT02488759|OG001|Outcome|Metastatic Combo A|Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796110|NCT02488759|OG002|Outcome|Metastatic Combo B|Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796111|NCT02488759|OG003|Outcome|Metastatic Combo C|Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796112|NCT02488759|OG004|Outcome|Metastatic Combo D|Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796113|NCT02488759|EG000|Reported Event|Metastatic Monotherapy|Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796114|NCT02488759|EG001|Reported Event|Metastatic Combo A|Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796115|NCT02488759|EG002|Reported Event|Metastatic Combo B|Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796116|NCT02488759|EG003|Reported Event|Metastatic Combo C|Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 month, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796117|NCT02488759|EG004|Reported Event|Metastatic Combo D|Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
10796118|NCT02488759|EG005|Reported Event|Neoadjuvant|Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
10796119|NCT02211131|BG000|Baseline|Surgery|Immediate surgical resection of melanoma lesion(s) any time during Weeks 1 to 6.
10796120|NCT02211131|BG001|Baseline|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796121|NCT02211131|BG002|Baseline|Total|Total of all reporting groups
10796122|NCT02211131|FG000|Participant Flow|Surgery|Immediate surgical resection of melanoma lesion(s) any time during Weeks 1 to 6.
10796123|NCT02211131|FG001|Participant Flow|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 plaque forming units (PFU)/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796124|NCT02211131|OG000|Outcome|Surgery|Immediate surgical resection of melanoma lesion(s) any time during Weeks 1 to 6.
10796125|NCT02211131|OG001|Outcome|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796126|NCT02211131|OG000|Outcome|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796127|NCT02211131|OG001|Outcome|Talimogene Laherparepvec: Pre-Surgery|"Talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesion(s).~Limited to participants who received at least 1 dose of talimogene laherparepvec and protocol-specified surgery."
10796128|NCT02211131|OG002|Outcome|Talimogene Laherparepvec: Post-Surgery|"Talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesion(s).~Limited to participants who received at least 1 dose of talimogene laherparepvec and protocol-specified surgery."
10796129|NCT02211131|OG003|Outcome|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796130|NCT02211131|OG000|Outcome|Talimogene Laherparepvec: Pre-Surgery|"Talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesion(s).~Limited to participants who received at least 1 dose of talimogene laherparepvec and protocol-specified surgery."
10796131|NCT02211131|OG001|Outcome|Talimogene Laherparepvec: Post-Surgery|"Talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesion(s).~Limited to participants who received at least 1 dose of talimogene laherparepvec and protocol-specified surgery."
10796132|NCT02211131|OG002|Outcome|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796133|NCT02211131|EG000|Reported Event|Surgery|Immediate surgical resection of melanoma lesion(s) any time during Weeks 1 to 6.
10796134|NCT02211131|EG001|Reported Event|Talimogene Laherparepvec Plus Surgery|"Talimogene laherparepvec up to 4.0 mL of 10^6 PFU/mL followed by up to 4.0 mL of 10^8 PFU/mL administered 21 (+5) days after the initial dose. Subsequent doses up to 4.0 mL of 10^8 PFU/mL every 14 (± 3) days until Week 12, all injectable tumors have disappeared, or intolerance of study treatment, whichever occurs first.~Followed by surgical resection of melanoma lesions(s) anytime during Weeks 13 to 18."
10796135|NCT02186847|BG000|Baseline|Chemoradiation|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796136|NCT02186847|BG001|Baseline|Metformin + Chemoradiation|Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796137|NCT02186847|BG002|Baseline|Total|Total of all reporting groups
10796138|NCT02186847|FG000|Participant Flow|Chemoradiation|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
11202259|NCT02206620|EG001|Reported Event|Placebo, Then Donepezil (Phase I)|Participants took the placebo at one tablet each day for 3 weeks, then increased the dosage to 2 tablets each day for 3 weeks. (This was followed by 6 weeks of a washout period and then taking donepezil in the same format -- donepezil 5mg tablet each day for 3 weeks, followed by 3 weeks of an increased dose of 10mg (2 tablets each day).)
11202260|NCT02206620|EG002|Reported Event|Donepezil, Then Placebo (Washout)|There were 6 weeks of a washout period after participants had taken donepezil for 6 weeks.
10796139|NCT02186847|FG001|Participant Flow|Metformin + Chemoradiation|Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796140|NCT02186847|OG000|Outcome|Chemoradiation|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796141|NCT02186847|OG001|Outcome|Metformin + Chemoradiation|Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796142|NCT02186847|EG000|Reported Event|Chemoradiation|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796143|NCT02186847|EG001|Reported Event|Metformin + Chemoradiation|Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10796144|NCT02101034|BG000|Baseline|Phase I: Dose Level 1|"PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796145|NCT02101034|BG001|Baseline|Phase I: Dose Level 2|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796146|NCT02101034|BG002|Baseline|Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796147|NCT02101034|BG003|Baseline|Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796148|NCT02101034|BG004|Baseline|Phase II Arm 3:|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796149|NCT02101034|BG005|Baseline|Total|Total of all reporting groups
10796150|NCT02101034|FG000|Participant Flow|Phase I: Dose Level 1|"PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796151|NCT02101034|FG001|Participant Flow|Phase I: Dose Level 2|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796152|NCT02101034|FG002|Participant Flow|Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796153|NCT02101034|FG003|Participant Flow|Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796154|NCT02101034|FG004|Participant Flow|Phase II Arm 3:|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796155|NCT02101034|OG000|Outcome|Phase I: Dose Level 1 and Dose Level 2|"PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.~Dose Level 1 PD 0332991 100 mg per day~Dose Level 2 PD 0332991 125 mg per day~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796156|NCT02101034|OG001|Outcome|Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796157|NCT02101034|OG002|Outcome|Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796158|NCT02101034|OG003|Outcome|Phase II Arm 3:|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
11202261|NCT02206620|EG003|Reported Event|Placebo, Then Donepezil (Washout)|There were 6 weeks of a washout period after participants had taken the placebo for 6 weeks.
10796159|NCT02101034|OG000|Outcome|Phase I: Dose Level 1|"PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796160|NCT02101034|OG001|Outcome|Phase I: Dose Level 2|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796161|NCT02101034|OG002|Outcome|Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796162|NCT02101034|OG003|Outcome|Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796163|NCT02101034|OG004|Outcome|Phase II Arm 3:|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796164|NCT02101034|OG000|Outcome|Phase II Arm 1, Arm 2, and Arm 3|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796165|NCT02101034|OG000|Outcome|Phase II: Arm 1, Arm 2, and Arm 3|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796166|NCT02101034|EG000|Reported Event|Phase I: Dose Level 1|"PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796167|NCT02101034|EG001|Reported Event|Phase I: Dose Level 2|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
11196048|NCT02162667|OG000|Outcome|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
11196049|NCT02162667|OG001|Outcome|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
10796168|NCT02101034|EG002|Reported Event|Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796169|NCT02101034|EG003|Reported Event|Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
11196050|NCT02162667|EG000|Reported Event|CT-P6|Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
11202262|NCT02206620|EG004|Reported Event|Donepezil, Then Placebo (Phase II)|After the washout period, participants took the placebo in the same format as the donepezil -- 3 weeks of one tablet, followed by 3 weeks of 2 tablets to replicate the dosage increase.
10796170|NCT02101034|EG004|Reported Event|Phase II Arm 3:|"PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.~Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study."
10796171|NCT02041533|BG000|Baseline|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
10796172|NCT02041533|BG001|Baseline|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
10796173|NCT02041533|BG002|Baseline|Total|Total of all reporting groups
10796174|NCT02041533|FG000|Participant Flow|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
10796175|NCT02041533|FG001|Participant Flow|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
10796176|NCT02041533|OG000|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
10796177|NCT02041533|OG001|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:~Squamous:~gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or~gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or~paclitaxel (200 mg/m2) with carboplatin (AUC 6)~Non-Squamous:~pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or~pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
10796178|NCT02041533|EG000|Reported Event|NIVOLUMAB 3 mg/kg|
10796179|NCT02041533|EG001|Reported Event|INVESTIGATOR CHOICE|
10796180|NCT01865617|BG000|Baseline|ALL (High Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796181|NCT01865617|BG001|Baseline|ALL (High Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796182|NCT01865617|BG002|Baseline|ALL (High Tumor Burden) Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796183|NCT01865617|BG003|Baseline|ALL (Low Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11196051|NCT02162667|EG001|Reported Event|Herceptin|Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
11196052|NCT02162680|BG000|Baseline|no Local Anesthetic|usual care practice of no local anesthetic administration
10796184|NCT01865617|BG004|Baseline|ALL (Low Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796185|NCT01865617|BG005|Baseline|CLL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796186|NCT01865617|BG006|Baseline|CLL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11196053|NCT02162680|BG001|Baseline|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
11196054|NCT02162680|BG002|Baseline|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
11196055|NCT02162680|BG003|Baseline|Total|Total of all reporting groups
10796187|NCT01865617|BG007|Baseline|CLL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796188|NCT01865617|BG008|Baseline|CLL (Ibrutinib) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796189|NCT01865617|BG009|Baseline|NHL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796190|NCT01865617|BG010|Baseline|NHL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796191|NCT01865617|BG011|Baseline|NHL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796192|NCT01865617|BG012|Baseline|NHL (Dose Dense) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796193|NCT01865617|BG013|Baseline|Total|Total of all reporting groups
10796194|NCT01865617|FG000|Participant Flow|ALL (High Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796195|NCT01865617|FG001|Participant Flow|ALL (High Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796196|NCT01865617|FG002|Participant Flow|ALL (High Tumor Burden) Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11196056|NCT02162680|FG000|Participant Flow|no Local Anesthetic|usual care practice of no local anesthetic administration
11196057|NCT02162680|FG001|Participant Flow|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
11196058|NCT02162680|FG002|Participant Flow|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
11196059|NCT02162680|OG000|Outcome|no Local Anesthetic|usual care practice of no local anesthetic administration
11196060|NCT02162680|OG001|Outcome|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
11196061|NCT02162680|OG002|Outcome|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
11196062|NCT02162680|EG000|Reported Event|no Local Anesthetic|usual care practice of no local anesthetic administration
11196063|NCT02162680|EG001|Reported Event|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
11196064|NCT02162680|EG002|Reported Event|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
11196065|NCT02162719|BG000|Baseline|Ipatasertib and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196066|NCT02162719|BG001|Baseline|Placebo and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196067|NCT02162719|BG002|Baseline|Total|Total of all reporting groups
10796197|NCT01865617|FG003|Participant Flow|ALL (Low Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796198|NCT01865617|FG004|Participant Flow|ALL (Low Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796199|NCT01865617|FG005|Participant Flow|CLL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796200|NCT01865617|FG006|Participant Flow|CLL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796201|NCT01865617|FG007|Participant Flow|CLL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796202|NCT01865617|FG008|Participant Flow|CLL (Ibrutinib) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796203|NCT01865617|FG009|Participant Flow|NHL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796204|NCT01865617|FG010|Participant Flow|NHL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796205|NCT01865617|FG011|Participant Flow|NHL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796206|NCT01865617|FG012|Participant Flow|NHL (Dose Dense) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796207|NCT01865617|OG000|Outcome|ALL (High Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796208|NCT01865617|OG001|Outcome|ALL (High Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796209|NCT01865617|OG002|Outcome|ALL (High Tumor Burden) Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796210|NCT01865617|OG003|Outcome|ALL (Low Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11202263|NCT02206620|EG005|Reported Event|Placebo, Then Donepezil (Phase II)|Then participants took donepezil in the same formats the placebo -- the donepezil 5mg tablet each day for 3 weeks, followed by 3 weeks of an increased dose of 10mg (2 tablets each day).
10796211|NCT01865617|OG004|Outcome|ALL (Low Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796212|NCT01865617|OG005|Outcome|CLL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796213|NCT01865617|OG006|Outcome|CLL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796214|NCT01865617|OG007|Outcome|CLL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796215|NCT01865617|OG008|Outcome|CLL (Ibrutinib) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796216|NCT01865617|OG009|Outcome|NHL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796217|NCT01865617|OG010|Outcome|NHL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796218|NCT01865617|OG011|Outcome|NHL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796219|NCT01865617|OG012|Outcome|NHL (Dose Dense) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796220|NCT01865617|OG000|Outcome|Acute Lymphocytic Leukemia Cohort|Cohort containing all ALL subtypes and treatment dose levels.
10796221|NCT01865617|OG001|Outcome|Non-Hodgkin Lymphoma Cohort|Cohort containing all NHL subtypes and treatment dose levels.
10796222|NCT01865617|OG002|Outcome|Chronic Lymphocytic Leukemia Cohort|Cohort containing all CLL subtypes and treatment dose levels.
10796223|NCT01865617|EG000|Reported Event|ALL (High Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796224|NCT01865617|EG001|Reported Event|ALL (High Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11196068|NCT02162719|FG000|Participant Flow|Ipatasertib and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196069|NCT02162719|FG001|Participant Flow|Placebo and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196070|NCT02162719|OG000|Outcome|Ipatasertib and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196071|NCT02162719|OG001|Outcome|Placebo and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
10796225|NCT01865617|EG002|Reported Event|ALL (High Tumor Burden) Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796226|NCT01865617|EG003|Reported Event|ALL (Low Tumor Burden) Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796227|NCT01865617|EG004|Reported Event|ALL (Low Tumor Burden) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796228|NCT01865617|EG005|Reported Event|CLL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796229|NCT01865617|EG006|Reported Event|CLL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796230|NCT01865617|EG007|Reported Event|CLL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796231|NCT01865617|EG008|Reported Event|CLL (Ibrutinib) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796232|NCT01865617|EG009|Reported Event|NHL Dose Level 1|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
11241209|NCT02485483|FG000|Participant Flow|VADERA I|Rheumatoid arthritis (RA) participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
10796233|NCT01865617|EG010|Reported Event|NHL Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796234|NCT01865617|EG011|Reported Event|NHL Dose Level 3|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796235|NCT01865617|EG012|Reported Event|NHL (Dose Dense) Dose Level 2|"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.~Disease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg~Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes: Given IV"
10796236|NCT01828112|BG000|Baseline|Ceritinib|Ceritinib 750 mg
10796237|NCT01828112|BG001|Baseline|Chemotherapy|Chemotherapy as determined by BIRC.
10796238|NCT01828112|BG002|Baseline|Total|Total of all reporting groups
10796239|NCT01828112|FG000|Participant Flow|Ceritinib|Ceritinib 750 mg
10796240|NCT01828112|FG001|Participant Flow|Chemotherapy|Chemotherapy as determined by BIRC.
10796241|NCT01828112|OG000|Outcome|Ceritinib|Ceritinib 750 mg
11241210|NCT02485483|FG001|Participant Flow|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
10796242|NCT01828112|OG001|Outcome|Chemotherapy|Chemotherapy as determined by BIRC.
10796243|NCT01828112|EG000|Reported Event|Ceritinib|Ceritinib 750 mg
10796244|NCT01828112|EG001|Reported Event|Chemotherapy|Chemotherapy as determined by BIRC.
10796245|NCT01733888|BG000|Baseline|In-office Bleaching|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
10796246|NCT01733888|BG001|Baseline|Resin Infiltration|Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
10796247|NCT01733888|BG002|Baseline|Resin Infiltration Twice|"Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant Icon is applied twice."
10796248|NCT01733888|BG003|Baseline|In-office Bleaching + Resin Infiltration|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
10796249|NCT01733888|BG004|Baseline|Total|Total of all reporting groups
10796250|NCT01733888|FG000|Participant Flow|In-office Bleaching|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
10796251|NCT01733888|FG001|Participant Flow|Resin Infiltration|Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
10796252|NCT01733888|FG002|Participant Flow|Resin Infiltration Twice|"Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant Icon is applied twice."
10796253|NCT01733888|FG003|Participant Flow|In-office Bleaching + Resin Infiltration|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
10796254|NCT01733888|OG000|Outcome|In-office Bleaching|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
10796255|NCT01733888|OG001|Outcome|Resin Infiltration|Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
10796256|NCT01733888|OG002|Outcome|Resin Infiltration Twice|"Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant Icon is applied twice."
10796257|NCT01733888|OG003|Outcome|In-office Bleaching + Resin Infiltration|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
10796258|NCT01733888|EG000|Reported Event|In-office Bleaching|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
10796259|NCT01733888|EG001|Reported Event|Resin Infiltration|Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
10796260|NCT01733888|EG002|Reported Event|Resin Infiltration Twice|"Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant Icon is applied twice."
10796261|NCT01733888|EG003|Reported Event|In-office Bleaching + Resin Infiltration|In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
11241211|NCT02485483|OG000|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
10796262|NCT01709981|BG000|Baseline|Colchicine|Colchicine
10796263|NCT01709981|BG001|Baseline|Placebo|Placebo
10796264|NCT01709981|BG002|Baseline|Total|Total of all reporting groups
10796265|NCT01709981|FG000|Participant Flow|Colchicine|"1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later~Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later"
10796266|NCT01709981|FG001|Participant Flow|Placebo|"Placebo 1-2 hours prior PCI, followed by placebo 1 hour later~Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later"
10796267|NCT01709981|OG000|Outcome|Colchicine|"1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later~Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later"
10796268|NCT01709981|OG001|Outcome|Placebo|"Placebo 1-2 hours prior PCI, followed by placebo 1 hour later~Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later"
10796269|NCT01709981|EG000|Reported Event|Colchicine|"1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later~Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later"
10796270|NCT01709981|EG001|Reported Event|Placebo|"Placebo 1-2 hours prior PCI, followed by placebo 1 hour later~Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later"
10796271|NCT01670500|BG000|Baseline|Doxorubicin-Cyclophosphamide|"Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4~Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses~Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses"
10796272|NCT01670500|BG001|Baseline|Cisplatin|"Cisplatin q 3 wk x 4~Cisplatin: administered intravenously every 3 weeks for 4 doses"
10796273|NCT01670500|BG002|Baseline|Total|Total of all reporting groups
10796274|NCT01670500|FG000|Participant Flow|Doxorubicin-Cyclophosphamide|"Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4~Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses~Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses"
10796275|NCT01670500|FG001|Participant Flow|Cisplatin|"Cisplatin q 3 wk x 4~Cisplatin: administered intravenously every 3 weeks for 4 doses"
10796276|NCT01670500|OG000|Outcome|Doxorubicin-Cyclophosphamide|"Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4~Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses~Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses"
10796277|NCT01670500|OG001|Outcome|Cisplatin|"Cisplatin q 3 wk x 4~Cisplatin: administered intravenously every 3 weeks for 4 doses"
10796278|NCT01670500|EG000|Reported Event|Doxorubicin-Cyclophosphamide|"Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4~Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses~Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses"
10796279|NCT01670500|EG001|Reported Event|Cisplatin|"Cisplatin q 3 wk x 4~Cisplatin: administered intravenously every 3 weeks for 4 doses"
10796280|NCT01593254|BG000|Baseline|Arm 1: Imatinib (≥400 mg)|Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. Participants randomized to Imatinib that crossover to Dasatinib (n= 42); Participants randomized to Imatinib, no crossover (n = 44)
10796281|NCT01593254|BG001|Baseline|Arm 2: Dasatinib (100 mg)|Dasatinib 100 mg tablet by mouth QD up to 60 months
10796282|NCT01593254|BG002|Baseline|Total|Total of all reporting groups
11241212|NCT02485483|OG000|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
10796283|NCT01593254|FG000|Participant Flow|Arm 1: Imatinib (≥400 mg)|Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. Participants randomized to Imatinib that crossover to Dasatinib (n= 42); Participants randomized to Imatinib, no crossover (n = 44)
10796284|NCT01593254|FG001|Participant Flow|Arm 2: Dasatinib (100 mg)|Dasatinib 100 mg tablet by mouth QD up to 60 months
10796285|NCT01593254|OG000|Outcome|Arm 1: Imatinib (≥400 mg)|Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. Participants randomized to Imatinib that crossover to Dasatinib (n= 42); Participants randomized to Imatinib, no crossover (n = 44)
10796286|NCT01593254|OG001|Outcome|Arm 2: Dasatinib (100 mg)|Dasatinib 100 mg tablet by mouth QD up to 60 months
10796287|NCT01593254|EG000|Reported Event|Randomized to Dasatinib|Dasatinib 100 mg tablet by mouth QD up to 60 months
10796288|NCT01593254|EG001|Reported Event|Rand to Imatinib(Crossover to Dasatinib)|Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
10796289|NCT01593254|EG002|Reported Event|Randomized to Imatinib (No Crossover)|Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
11241213|NCT02485483|EG000|Reported Event|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11241214|NCT02485483|EG001|Reported Event|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11241215|NCT02485561|BG000|Baseline|Information Only|"INTERVENTION: Information about colon cancer and screening tests.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
10796290|NCT01453101|BG000|Baseline|Fludarabine, Melphalan, Bortezomib|"Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.~Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2~Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan."
10796291|NCT01453101|FG000|Participant Flow|Fludarabine, Melphalan, Bortezomib|"Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.~Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2~Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan."
10796292|NCT01453101|OG000|Outcome|Fludarabine, Melphalan, Bortezomib|"Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.~Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2~Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan."
10796293|NCT01453101|EG000|Reported Event|Fludarabine, Melphalan, Bortezomib|"Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.~Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2~Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan."
10796294|NCT04604184|BG000|Baseline|BI 764198 Treatment Group|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796295|NCT04604184|BG001|Baseline|Placebo|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796296|NCT04604184|BG002|Baseline|Total|Total of all reporting groups
10796297|NCT04604184|FG000|Participant Flow|BI 764198 Treatment Group|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796298|NCT04604184|FG001|Participant Flow|Placebo|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796299|NCT04604184|OG000|Outcome|BI 764198 Treatment Group|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796300|NCT04604184|OG001|Outcome|Placebo|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796301|NCT04604184|EG000|Reported Event|BI 764198 Treatment Group|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
11196072|NCT02162719|EG000|Reported Event|Ipatasertib and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
11196073|NCT02162719|EG001|Reported Event|Placebo and Paclitaxel|Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
10796302|NCT04604184|EG001|Reported Event|Placebo|Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
10796303|NCT04368429|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
10796304|NCT04368429|BG001|Baseline|Group 2: Menactra® Vaccine|Participants received a single IM dose of Menactra® vaccine on Day 0.
10796305|NCT04368429|BG002|Baseline|Total|Total of all reporting groups
10796306|NCT04368429|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Participants received a single intramuscular (IM) dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 0.
10796307|NCT04368429|FG001|Participant Flow|Group 2: Menactra® Vaccine|Participants received a single IM dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine) on Day 0.
10796308|NCT04368429|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
10796309|NCT04368429|OG001|Outcome|Group 2: Menactra® Vaccine|Participants received a single IM dose of Menactra® vaccine on Day 0.
10796310|NCT04368429|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
10796311|NCT04368429|EG001|Reported Event|Group 2: Menactra® Vaccine|Participants received a single IM dose of Menactra® vaccine on Day 0.
10796312|NCT04266158|BG000|Baseline|0 - See Description Below|The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.non-randomized and administered to all subjects.
10796313|NCT04266158|FG000|Participant Flow|0 - See Description|The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.
10796314|NCT04266158|OG000|Outcome|0 - See Description Below|The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.
10796315|NCT04266158|EG000|Reported Event|0 - See Description Below|The PI is no longer at The Ohio State University and is not actively working at another institution for record transfer. We contacted remaining study team members and department chair to obtain updates for these records. We were told the PI was dismissed and there was alleged noncompliance and misconduct. The study team and department chair are unable to confirm if available documents for these records are accurate.
10796316|NCT04155840|BG000|Baseline|Treatment (Copanlisib, Rituximab, Bendamustine)|"Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.~Copanlisib: Given IV~Rituximab: Given IV~Bendamustine: Given IV"
10796317|NCT04155840|FG000|Participant Flow|Treatment (Copanlisib, Rituximab, Bendamustine)|"Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.~Copanlisib: Given IV~Rituximab: Given IV~Bendamustine: Given IV"
10796318|NCT04155840|OG000|Outcome|Treatment (Copanlisib, Rituximab, Bendamustine)|"Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.~Copanlisib: Given IV~Rituximab: Given IV~Bendamustine: Given IV"
10796319|NCT04155840|EG000|Reported Event|Treatment (Copanlisib, Rituximab, Bendamustine)|"Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.~Copanlisib: Given IV~Rituximab: Given IV~Bendamustine: Given IV"
11196074|NCT02162758|BG000|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
11196075|NCT02162758|BG001|Baseline|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
10803104|NCT02448225|BG000|Baseline|Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
11196076|NCT02162758|BG002|Baseline|Total|Total of all reporting groups
11196077|NCT02162758|FG000|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
11196078|NCT02162758|FG001|Participant Flow|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
11196079|NCT02162758|OG000|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
11196080|NCT02162758|OG001|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
11196081|NCT02162758|EG000|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
11196082|NCT02162758|EG001|Reported Event|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
11196083|NCT02162771|BG000|Baseline|CT-P10|"Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
10803105|NCT02448225|FG000|Participant Flow|Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
11196084|NCT02162771|BG001|Baseline|Rituxan|"Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
11196085|NCT02162771|BG002|Baseline|Total|Total of all reporting groups
11196086|NCT02162771|FG000|Participant Flow|CT-P10|"Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
10796320|NCT03865316|BG000|Baseline|SedLine Vs Comparator Test Group|SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
10796321|NCT03865316|FG000|Participant Flow|SedLine Vs Comparator Test Group|SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
10796322|NCT03865316|OG000|Outcome|SedLine Vs Comparator Test Group|SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
10796323|NCT03865316|EG000|Reported Event|SedLine Vs Comparator Test Group|SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
10796324|NCT03688555|BG000|Baseline|ACT-774312|Participants received ACT-774312 400 mg twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796325|NCT03688555|BG001|Baseline|Placebo|Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796326|NCT03688555|BG002|Baseline|Total|Total of all reporting groups
10796327|NCT03688555|FG000|Participant Flow|Mometasone Furoate|All participants were placed on non-investigational, standard background therapy: Mometasone furoate nasal spray 50 μg/actuation nasal spray, suspension for 4 weeks (Visit 1 to Visit 2). Dosing regimen: 2 actuations (50 μg/actuation) in each nostril twice daily (or once daily if twice daily was not tolerated).
10796328|NCT03688555|FG001|Participant Flow|ACT-774312|Participants received ACT-774312 400 mg twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796329|NCT03688555|FG002|Participant Flow|Placebo|Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
11337839|NCT03595280|FG002|Participant Flow|Tailored Messages|"Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
10796330|NCT03688555|OG000|Outcome|ACT-774312|Participants received ACT-774312 (400 mg twice daily) in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796331|NCT03688555|OG001|Outcome|Placebo|Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796332|NCT03688555|OG001|Outcome|Placebo|Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks.In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796333|NCT03688555|EG000|Reported Event|ACT-774312|Participants received ACT-774312 400 mg twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796334|NCT03688555|EG001|Reported Event|Placebo|Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray.
10796335|NCT03593213|BG000|Baseline|Placebo (Double-blind Treatment Period)|Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796336|NCT03593213|BG001|Baseline|Cariprazine 3.0 mg/Day (Double-blind Treatment Period)|Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796337|NCT03593213|BG002|Baseline|Cariprazine 4.5 mg/Day (Double-blind Treatment Period)|Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796338|NCT03593213|BG003|Baseline|Total|Total of all reporting groups
10796339|NCT03593213|FG000|Participant Flow|Cariprazine 4.5 mg/Day (Open-label Treatment Period)|Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
10796340|NCT03593213|FG001|Participant Flow|Placebo (Double-blind Treatment Period)|Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796341|NCT03593213|FG002|Participant Flow|Cariprazine 3.0 mg/Day (Double-blind Treatment Period)|Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796342|NCT03593213|FG003|Participant Flow|Cariprazine 4.5 mg/Day (Double-blind Treatment Period)|Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796343|NCT03593213|OG000|Outcome|Placebo (Double-blind Treatment Period)|Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796344|NCT03593213|OG001|Outcome|Cariprazine 3.0 mg/Day (Double-blind Treatment Period)|Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796345|NCT03593213|OG002|Outcome|Cariprazine 4.5 mg/Day (Double-blind Treatment Period)|Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796346|NCT03593213|EG000|Reported Event|Cariprazine 4.5 mg/Day (Open-label Treatment Period)|Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
10796347|NCT03593213|EG001|Reported Event|Cariprazine 4.5 mg/Day (Open-label Safety Follow-up)|Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Open-label Treatment Period for participants who did not continue to the Double-blind Treatment Period.
10796348|NCT03593213|EG002|Reported Event|Placebo (Double-blind Treatment Period)|Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796349|NCT03593213|EG003|Reported Event|Cariprazine 3.0 mg/Day (Double-blind Treatment Period)|Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796350|NCT03593213|EG004|Reported Event|Cariprazine 4.5 mg/Day (Double-blind Treatment Period)|Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
10796351|NCT03593213|EG005|Reported Event|Placebo (Double-blind Safety Follow-up)|Safety Follow-up Period following treatment with Placebo in the Double-blind Treatment Period.
10796352|NCT03593213|EG006|Reported Event|Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up)|Safety Follow-up Period following treatment with Cariprazine 3.0 mg/day in the Double-blind Treatment Period.
10796353|NCT03593213|EG007|Reported Event|Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up)|Safety Follow-up Period following treatment with Cariprazine 4.5 mg/day in the Double-blind Treatment Period.
10796354|NCT03349723|BG000|Baseline|3 Microgram BI 1265162|3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796355|NCT03349723|BG001|Baseline|10 Microgram BI 1265162|10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796356|NCT03349723|BG002|Baseline|30 Microgram BI 1265162|30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796357|NCT03349723|BG003|Baseline|100 Microgram BI 1265162|100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796358|NCT03349723|BG004|Baseline|300 Microgram BI 1265162|300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796359|NCT03349723|BG005|Baseline|600 Microgram BI 1265162|600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796360|NCT03349723|BG006|Baseline|1200 Microgram BI 1265162|1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796361|NCT03349723|BG007|Baseline|Placebo Matching BI 1265162|Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
11337840|NCT03595280|OG000|Outcome|Control|Participants in the control group receive no study messages
10796362|NCT03349723|BG008|Baseline|Total|Total of all reporting groups
10796363|NCT03349723|FG000|Participant Flow|3 Microgram BI 1265162|3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796364|NCT03349723|FG001|Participant Flow|10 Microgram BI 1265162|10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796365|NCT03349723|FG002|Participant Flow|30 Microgram BI 1265162|30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796366|NCT03349723|FG003|Participant Flow|100 Microgram BI 1265162|100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796367|NCT03349723|FG004|Participant Flow|300 Microgram BI 1265162|300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796368|NCT03349723|FG005|Participant Flow|600 Microgram BI 1265162|600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796369|NCT03349723|FG006|Participant Flow|1200 Microgram BI 1265162|1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796370|NCT03349723|FG007|Participant Flow|Placebo Matching BI 1265162|Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
10796371|NCT03349723|OG000|Outcome|3 Microgram BI 1265162|3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796372|NCT03349723|OG001|Outcome|10 Microgram BI 1265162|10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796373|NCT03349723|OG002|Outcome|30 Microgram BI 1265162|30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796374|NCT03349723|OG003|Outcome|100 Microgram BI 1265162|100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796375|NCT03349723|OG004|Outcome|300 Microgram BI 1265162|300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796376|NCT03349723|OG005|Outcome|600 Microgram BI 1265162|600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796377|NCT03349723|OG006|Outcome|1200 Microgram BI 1265162|1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796378|NCT03349723|OG007|Outcome|Placebo Matching BI 1265162|Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
10796379|NCT03349723|EG000|Reported Event|3 Microgram BI 1265162|3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796380|NCT03349723|EG001|Reported Event|10 Microgram BI 1265162|10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796381|NCT03349723|EG002|Reported Event|30 Microgram BI 1265162|30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796382|NCT03349723|EG003|Reported Event|100 Microgram BI 1265162|100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796383|NCT03349723|EG004|Reported Event|300 Microgram BI 1265162|300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796384|NCT03349723|EG005|Reported Event|600 Microgram BI 1265162|600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796385|NCT03349723|EG006|Reported Event|1200 Microgram BI 1265162|1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
10796386|NCT03349723|EG007|Reported Event|Placebo Matching BI 1265162|Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
10796387|NCT03248531|BG000|Baseline|Placebo|Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.
10796388|NCT03248531|BG001|Baseline|Adalimumab|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.
10796389|NCT03248531|BG002|Baseline|Bimekizumab|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.
10796390|NCT03248531|BG003|Baseline|Total Title|
10796391|NCT03248531|FG000|Participant Flow|Placebo|Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.
10796392|NCT03248531|FG001|Participant Flow|Adalimumab|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.
10796393|NCT03248531|FG002|Participant Flow|Bimekizumab|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.
10796394|NCT03248531|OG000|Outcome|Placebo (PPS)|Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).
10796395|NCT03248531|OG001|Outcome|Adalimumab (PPS)|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.
10796396|NCT03248531|OG002|Outcome|Bimekizumab (PPS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
10796397|NCT03248531|OG000|Outcome|Bimekizumab (PK-PPS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).
10796398|NCT03248531|OG000|Outcome|Bimekizumab (PK-PPS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
10796399|NCT03248531|OG000|Outcome|Placebo (SS)|Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
10796400|NCT03248531|OG001|Outcome|Adalimumab (SS)|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
10796401|NCT03248531|OG002|Outcome|Bimekizumab (SS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
10796402|NCT03248531|OG001|Outcome|Adalimumab (SS)|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
10796403|NCT03248531|OG002|Outcome|Bimekizumab (SS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
10796404|NCT03248531|EG000|Reported Event|Placebo (SS)|Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
10796405|NCT03248531|EG001|Reported Event|Adalimumab (SS)|Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
10796406|NCT03248531|EG002|Reported Event|Bimekizumab (SS)|Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
10796407|NCT03205605|BG000|Baseline|Oxybutynin Patch and Gel|First study session received one oxybutynin patch (Oxytrol for Women), then at least one week washout period Second study session received oxybutynin gel (Gelnique), then at least one week washout period Third study session received one oxybutynin patch (Oxytrol for Women) with early and late heat (90 minutes) exposure, then at least one week washout period Fourth study session received oxybutynin gel (Gelnique) with occlusion (3 hours)
10796408|NCT03205605|FG000|Participant Flow|Oxybutynin Patch and Gel|First study session received one oxybutynin patch (Oxytrol for Women), then at least one week washout period Second study session received oxybutynin gel (Gelnique), then at least one week washout period Third study session received one oxybutynin patch (Oxytrol for Women) with early and late heat (90 minutes) exposure, then at least one week washout period Fourth study session received oxybutynin gel (Gelnique) with occlusion (3 hours)
10796409|NCT03205605|OG000|Outcome|Oxytrol for Women Patch (Baseline)|baseline (no heat exposure)
10796410|NCT03205605|OG001|Outcome|Oxytrol for Women Patch (Heat Exposure)|external heat exposure at 24-25.5 h and 30-31.5 h
10796411|NCT03205605|OG000|Outcome|Gelnique Gel (Baseline)|Gelnique gel applied for 12 h duration; no occlusion
10796412|NCT03205605|OG001|Outcome|Gelnique Gel (Occlusion)|Gelnique gel applied for 12 h duration; occluded from 7-10 h
10796413|NCT03205605|EG000|Reported Event|Baseline Patch|"patch~oxybutynin: patch"
10796414|NCT03205605|EG001|Reported Event|Baseline Gel|"gel~oxybutynin: gel"
10796415|NCT03205605|EG002|Reported Event|Patch With Heat|"patch~oxybutynin: patch"
10796416|NCT03205605|EG003|Reported Event|Gel With Occlusion|"gel~oxybutynin: gel"
10803106|NCT02448225|OG000|Outcome|Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
10803107|NCT02448225|OG000|Outcome|Some Cancer Patients|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
10803108|NCT02448225|OG000|Outcome|Benign Patients|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
10803109|NCT02448225|OG001|Outcome|Cancer Patients|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT"
10803110|NCT02448225|EG000|Reported Event|Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)|"Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.~Computed Tomography: Undergo 18F-FDG PET/CT - standard of care~Computed Tomography: Undergo 18F-FSPG PET/CT~fluorodeoxyglucose F-18: Undergo 18F-FDG PET/CT - standard of care~Fluorine F 18 L-glutamate Derivative BAY94-9392: Undergo 18F-FSPG PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo 18F-FDG PET/CT - standard of care~Positron Emission Tomography (PET): Undergo 18F-FSPG PET/CT"
10803111|NCT02352948|BG000|Baseline|Sub-study A: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803112|NCT02352948|BG001|Baseline|Sub-study A: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803113|NCT02352948|BG002|Baseline|Sub-study B: Durvalumab+Tremelimumab|Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
10803114|NCT02352948|BG003|Baseline|Sub-study B: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803115|NCT02352948|BG004|Baseline|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803116|NCT02352948|BG005|Baseline|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
10803117|NCT02352948|BG006|Baseline|Total|Total of all reporting groups
10803118|NCT02352948|FG000|Participant Flow|Sub-study A: Durvalumab|Participants received durvalumab (MEDI4736) 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) for 12 months (up to 26 doses).
10803119|NCT02352948|FG001|Participant Flow|Sub-study A: Standard of Care (SoC)|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/meter square (m^2) IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until progression of disease (PD), initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803120|NCT02352948|FG002|Participant Flow|Sub-study B: Durvalumab+Tremelimumab|Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion every 4 weeks (Q4W) for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
10803121|NCT02352948|FG003|Participant Flow|Sub-study B: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803122|NCT02352948|FG004|Participant Flow|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10796417|NCT02556736|BG000|Baseline|RST-001|Single intravitreal injection of RST-001
10796418|NCT02556736|FG000|Participant Flow|RST-001|Single intravitreal injection of RST-001
10796419|NCT02556736|OG000|Outcome|RST-001|Single intravitreal injection of RST-001
10796420|NCT02556736|EG000|Reported Event|RST-001|Single intravitreal injection of RST-001
10796421|NCT02484456|BG000|Baseline|AV 101 (4-chlorokynurenine), Then Placebo|After a two-week drug-free period, participants received daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,080mg/day for seven days, then dose increased to AV 101 1,440mg/day for next seven days followed by a two-week washout period; then crossover to placebo phase with daily dose of placebo pill for two weeks.
10796422|NCT02484456|BG001|Baseline|Placebo, Then AV 101 (4-chlorokynurenine)|After a two-week drug-free period, participants received daily dose of placebo pill for two weeks followed by two-week washout period; then crossover to AV 101 (4-chlorokynurenine) treatment phase with daily oral dose of AV 101 monotherapy 1,080mg/day for seven days, then dose increased to AV 101 1,440mg/day for next seven days.
10796423|NCT02484456|BG002|Baseline|Total|Total of all reporting groups
10796424|NCT02484456|FG000|Participant Flow|AV 101 (4-chlorokynurenine), Then Placebo|After a two-week drug-free period, participants received daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,080mg/day for seven days, then dose increased to AV 101 1,440mg/day for next seven days followed by a two-week washout period; then crossover to placebo phase with daily dose of placebo pill for two weeks.
10796425|NCT02484456|FG001|Participant Flow|Placebo, Then AV 101 (4-chlorokynurenine)|After a two-week drug-free period, participants received daily dose of placebo pill for two weeks followed by two-week washout period; then crossover to AV 101 (4-chlorokynurenine) treatment phase with daily oral dose of AV 101 monotherapy 1,080mg/day for seven days, then dose increased to AV 101 1,440mg/day for next seven days.
10796426|NCT02484456|OG000|Outcome|AV 101 (4-chlorokynurenine)|Participants received daily oral dose of AV 101 monotherapy 1,080mg/day for seven days, then 1,440mg/day for next seven days.
10796427|NCT02484456|OG001|Outcome|Placebo|Participants received a daily oral dose of placebo pills for 2 weeks.
10796428|NCT02484456|EG000|Reported Event|AV 101 (4-chlorokynurenine) 1,080 mg for 1 Week|Daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,080mg/day for seven days
10796429|NCT02484456|EG001|Reported Event|AV 101 (4-chlorokynurenine) 1,440 mg for 1 Week|Daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,440 mg/day for seven days
10796430|NCT02484456|EG002|Reported Event|Placebo 2 Weeks|Daily dose of placebo pill for two weeks
10796431|NCT02481830|BG000|Baseline|Group A|Nivolumab 240mg
10796432|NCT02481830|BG001|Baseline|Group B|Chemotherapy (Topotecan/Amrubicin)
10796433|NCT02481830|BG002|Baseline|Total|Total of all reporting groups
10796434|NCT02481830|FG000|Participant Flow|Group A|Nivolumab 240mg
10796435|NCT02481830|FG001|Participant Flow|Group B|Chemotherapy (Topotecan/Amrubicin)
10796436|NCT02481830|OG000|Outcome|Group A|Nivolumab 240mg
10796437|NCT02481830|OG001|Outcome|Group B|Chemotherapy (Topotecan/Amrubicin)
10796438|NCT02481830|EG000|Reported Event|Group A|Nivolumab 240mg
10796439|NCT02481830|EG001|Reported Event|Group B|Chemotherapy (Topotecan/Amrubicin)
10796440|NCT02234323|BG000|Baseline|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -PR: rFVIIIFc 25-80 IU/kg, at 3- to 5-day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 BU/mL) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10796441|NCT02234323|FG000|Participant Flow|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -Prophylaxis regimen (PR): rFVIIIFc 25-80 international units per kilogram (IU/kg), at 3-5 day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER (Episodic regimen) can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 Bethesda Units per milliliter [BU/mL]) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10796442|NCT02234323|OG000|Outcome|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -PR (Prophylaxis regimen): rFVIIIFc 25-80 IU/kg, at 3- to 5-day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 BU/mL) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10796443|NCT02234323|OG000|Outcome|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -PR: rFVIIIFc 25-80 IU/kg, at 3- to 5-day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 BU/mL) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10803123|NCT02352948|FG005|Participant Flow|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by every 12 weeks (Q12W) for 24 weeks (up to 9 doses).
10803124|NCT02352948|OG000|Outcome|Sub-study A: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10796444|NCT02234323|OG000|Outcome|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -PR: rFVIIIFc 25-80 IU/kg, at 3- to 5-day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER (Episodic regimen) can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 BU/mL) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10796445|NCT02234323|EG000|Reported Event|Recombinant Coagulation Factor VIII Fc Fusion Protein|Participants were to receive rFVIIIFc as follows -PR: rFVIIIFc 25-80 IU/kg, at 3- to 5-day intervals until participant reached >= 50 exposure days (ED: 24-hour period in which >=1 injection/dose of rFVIIIFc was given), or study withdrawal/end of study. Adjustments to dose/dosing interval was done as needed by investigator; Treatment with an optional ER can be initiated before PR at investigators discretion; ITI: rFVIIIFc 200 IU/kg, daily for participants who, after exposure to rFVIIIFc, had positive high titer inhibitor (>=5.00 BU/mL) or positive low titer inhibitor (>=0.60 and <5.00 BU/mL) and had poorly controlled bleeding despite increased rFVIIIFc doses, or required bypassing agent to treat bleeding.
10796446|NCT02220855|BG000|Baseline|BKM120|BKM120, 100mg capsule for oral use, taken once daily for two or more months for a maximum of one year. Each cycle is 28 days.
10796447|NCT02220855|FG000|Participant Flow|BKM120|BKM120, 100mg capsule for oral use, taken once daily for two or more months for a maximum of one year. Each cycle is 28 days.
10796448|NCT02220855|OG000|Outcome|BKM120|BKM120, 100mg capsule for oral use, taken once daily for two or more months for a maximum of one year. Each cycle is 28 days.
10796449|NCT02220855|EG000|Reported Event|BKM120|BKM120, 100mg capsule for oral use, taken once daily for two or more months for a maximum of one year. Each cycle is 28 days.
10796450|NCT01791595|BG000|Baseline|AZD3965 Cohort 1 (5 mg OD)|"AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796451|NCT01791595|BG001|Baseline|AZD3965 Cohort 2 (10 mg OD)|"AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796452|NCT01791595|BG002|Baseline|AZD3965 Cohort 3 (20 mg OD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796453|NCT01791595|BG003|Baseline|AZD3965 Cohort 4 (30 mg OD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796454|NCT01791595|BG004|Baseline|AZD3965 Cohort 5 (15 mg BD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796455|NCT01791595|BG005|Baseline|AZD3965 Cohort 6 (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796456|NCT01791595|BG006|Baseline|AZD3965 Expansion Cohort (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796457|NCT01791595|BG007|Baseline|Total|Total of all reporting groups
10796458|NCT01791595|FG000|Participant Flow|AZD3965 Cohort 1 (5 mg OD)|"AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796459|NCT01791595|FG001|Participant Flow|AZD3965 Cohort 2 (10 mg OD)|"AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796460|NCT01791595|FG002|Participant Flow|AZD3965 Cohort 3 (20 mg OD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796461|NCT01791595|FG003|Participant Flow|AZD3965 Cohort 4 (30 mg OD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
11202264|NCT02206685|BG000|Baseline|Treatment Group|"The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.~Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes"
10796462|NCT01791595|FG004|Participant Flow|AZD3965 Cohort 5 (15 mg BD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796463|NCT01791595|FG005|Participant Flow|AZD3965 Cohort 6 (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796464|NCT01791595|FG006|Participant Flow|AZD3965 Expansion Cohort (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796465|NCT01791595|OG000|Outcome|Part 1 Dose Escalation (Cohorts 1-6)|All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
10796466|NCT01791595|OG000|Outcome|AZD3965 Cohort 1 (5 mg OD)|"AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796467|NCT01791595|OG001|Outcome|AZD3965 Cohort 2 (10 mg OD)|"AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796468|NCT01791595|OG002|Outcome|AZD3965 Cohort 3 (20 mg OD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796469|NCT01791595|OG003|Outcome|AZD3965 Cohort 4 (30 mg OD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796470|NCT01791595|OG004|Outcome|AZD3965 Cohort 5 (15 mg BD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796471|NCT01791595|OG005|Outcome|AZD3965 Cohort 6 (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796472|NCT01791595|OG006|Outcome|AZD3965 Expansion Cohort (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796473|NCT01791595|OG000|Outcome|AZD3965 Cohort 5 (15 mg BD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796474|NCT01791595|OG001|Outcome|AZD3965 Cohort 6 (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796475|NCT01791595|OG000|Outcome|AZD3965 Expansion Cohort (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796476|NCT01791595|EG000|Reported Event|AZD3965 Cohort 1 (5 mg OD)|"AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796477|NCT01791595|EG001|Reported Event|AZD3965 Cohort 2 (10 mg OD)|"AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796478|NCT01791595|EG002|Reported Event|AZD3965 Cohort 3 (20 mg OD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796479|NCT01791595|EG003|Reported Event|AZD3965 Cohort 4 (30 mg OD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796480|NCT01791595|EG004|Reported Event|AZD3965 Cohort 5 (15 mg BD)|"AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796481|NCT01791595|EG005|Reported Event|AZD3965 Cohort 6 (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796482|NCT01791595|EG006|Reported Event|AZD3965 Expansion Cohort (10 mg BD)|"AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).~Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.~Patients benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor."
10796483|NCT01192776|BG000|Baseline|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796484|NCT01192776|BG001|Baseline|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796485|NCT01192776|BG002|Baseline|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796486|NCT01192776|BG003|Baseline|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796487|NCT01192776|BG004|Baseline|Total|Total of all reporting groups
10796488|NCT01192776|FG000|Participant Flow|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796489|NCT01192776|FG001|Participant Flow|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796490|NCT01192776|FG002|Participant Flow|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796491|NCT01192776|FG003|Participant Flow|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796492|NCT01192776|OG000|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796493|NCT01192776|OG001|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796494|NCT01192776|OG002|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796495|NCT01192776|OG003|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796496|NCT01192776|OG001|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796497|NCT01192776|OG002|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796498|NCT01192776|EG000|Reported Event|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796499|NCT01192776|EG001|Reported Event|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796500|NCT01192776|EG002|Reported Event|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796501|NCT01192776|EG003|Reported Event|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs~Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
10796502|NCT00089791|BG000|Baseline|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
10796503|NCT00089791|BG001|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
10796504|NCT00089791|BG002|Baseline|Total|Total of all reporting groups
10796505|NCT00089791|FG000|Participant Flow|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
10796506|NCT00089791|FG001|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
10796507|NCT00089791|OG000|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
10796508|NCT00089791|OG001|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
10796509|NCT00089791|EG000|Reported Event|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
10796510|NCT00089791|EG001|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
10803125|NCT02352948|OG001|Outcome|Sub-study A: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803126|NCT02352948|OG002|Outcome|Sub-study B: Durvalumab+Tremelimumab|Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
10803127|NCT02352948|OG003|Outcome|Sub-study B: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803128|NCT02352948|OG000|Outcome|Sub-study B: Durvalumab+Tremelimumab|Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
10803129|NCT02352948|OG001|Outcome|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803130|NCT02352948|OG002|Outcome|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
10803131|NCT02352948|OG004|Outcome|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803132|NCT02352948|OG005|Outcome|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
10803133|NCT02352948|OG001|Outcome|Sub-study B: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803134|NCT02352948|OG002|Outcome|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803135|NCT02352948|OG003|Outcome|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
10803136|NCT02352948|EG000|Reported Event|Sub-study A: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803137|NCT02352948|EG001|Reported Event|Sub-study A: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803138|NCT02352948|EG002|Reported Event|Sub-study B: Durvalumab+Tremelimumab|Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
10803139|NCT02352948|EG003|Reported Event|Sub-study B: SoC|Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
10803140|NCT02352948|EG004|Reported Event|Sub-study B: Durvalumab|Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
10803141|NCT02352948|EG005|Reported Event|Sub-study B: Tremelimumab|Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
10803142|NCT02318095|BG000|Baseline|Chemotherapy/Radiation/Surgery|"Gemcitabine/nab-Paclitaxel: Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.~Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap"
10803143|NCT02318095|FG000|Participant Flow|Chemotherapy/Radiation/Surgery|"This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.~Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap"
11196087|NCT02162771|FG001|Participant Flow|Rituxan|"Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
10796511|NCT03397264|BG000|Baseline|Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796512|NCT03397264|BG001|Baseline|Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796513|NCT03397264|BG002|Baseline|Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796514|NCT03397264|BG003|Baseline|Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796515|NCT03397264|BG004|Baseline|Ph 2a: 2.0 mg Aflibercept With Sham|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection~Aflibercept: Intravitreal injection~Sham intravitreal injection: Sham (mock) intravitreal injection"
10796516|NCT03397264|BG005|Baseline|Total|Total of all reporting groups
10796517|NCT03397264|FG000|Participant Flow|Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796518|NCT03397264|FG001|Participant Flow|Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796519|NCT03397264|FG002|Participant Flow|Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796520|NCT03397264|FG003|Participant Flow|Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796521|NCT03397264|FG004|Participant Flow|Ph 2a: 2.0 mg Aflibercept With Sham|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection~Aflibercept: Intravitreal injection~Sham intravitreal injection: Sham (mock) intravitreal injection"
10796522|NCT03397264|OG000|Outcome|Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796523|NCT03397264|OG001|Outcome|Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796524|NCT03397264|OG002|Outcome|Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796525|NCT03397264|OG003|Outcome|Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796526|NCT03397264|OG004|Outcome|Ph 2a: 2.0 mg Aflibercept With Sham|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection~Aflibercept: Intravitreal injection~Sham intravitreal injection: Sham (mock) intravitreal injection"
10796527|NCT03397264|OG000|Outcome|Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed highest tested or maximum tolerated dose from Phase 1b OPT-302 intravitreal injection (0.05 mL) (2.0 mg)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796528|NCT03397264|EG000|Reported Event|Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796529|NCT03397264|EG001|Reported Event|Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796530|NCT03397264|EG002|Reported Event|Ph 1b: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796531|NCT03397264|EG003|Reported Event|Ph 2a: 2.0 mg Aflibercept With 2.0 mg OPT-302|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)~Aflibercept: Intravitreal injection~OPT-302: Intravitreal Injection"
10796532|NCT03397264|EG004|Reported Event|Ph 2a: 2.0 mg Aflibercept With Sham|"2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection~Aflibercept: Intravitreal injection~Sham intravitreal injection: Sham (mock) intravitreal injection"
10796533|NCT03392883|BG000|Baseline|Patients in Digital Health Assisted Mental Healthcare Intervention|"This Digital Health Assisted Mental Healthcare intervention will be based on the novel mobile-based platform (Laddr® from Square2 Systems).~Laddr: Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management."
10796534|NCT03392883|BG001|Baseline|Providers in Digital Health Assisted Mental Healthcare Intervention|Providers at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796535|NCT03392883|BG002|Baseline|Administrative Staff in Digital Health Assisted Mental Healthcare Intervention|Administrative staff at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796536|NCT03392883|BG003|Baseline|Total|Total of all reporting groups
10796537|NCT03392883|FG000|Participant Flow|Patients in Digital Health Assisted Mental Healthcare Intervention|"Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool.~Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management."
10796538|NCT03392883|FG001|Participant Flow|Providers in Digital Health Assisted Mental Healthcare Intervention|Providers at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796539|NCT03392883|FG002|Participant Flow|Administrative Staff in Digital Health Assisted Mental Healthcare Intervention|Administrative staff at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796540|NCT03392883|OG000|Outcome|Patients in Digital Health Assisted Mental Healthcare Intervention|"Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool.~Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management."
10796541|NCT03392883|OG000|Outcome|Providers in Digital Health Assisted Mental Healthcare Intervention|Providers at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796542|NCT03392883|OG000|Outcome|Administrative Staff in Digital Health Assisted Mental Healthcare Intervention|Administrative staff at partnering primary care sites will all be offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
10796543|NCT03392883|EG000|Reported Event|Patients in Digital Health Assisted Mental Healthcare Intervention|"Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool.~Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management."
10803144|NCT02318095|OG000|Outcome|Chemotherapy/Radiation/Surgery|"This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.~Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy."
10803145|NCT02318095|OG000|Outcome|Chemotherapy/Radiation/Surgery|"This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.~Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap"
10803146|NCT02318095|EG000|Reported Event|Chemotherapy/Radiation/Surgery|"This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.~Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap"
10803147|NCT02257528|BG000|Baseline|Treatment (Nivolumab)|Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
10803148|NCT02257528|FG000|Participant Flow|Treatment (Nivolumab)|Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
10803149|NCT02257528|OG000|Outcome|Treatment (Nivolumab)|Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
10803150|NCT02257528|EG000|Reported Event|Treatment (Nivolumab)|Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
10803151|NCT02155647|BG000|Baseline|Part A: Avelumab|Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803152|NCT02155647|BG001|Baseline|Part B: Avelumab|Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803153|NCT02155647|BG002|Baseline|Total|Total of all reporting groups
10796544|NCT03376789|BG000|Baseline|MYL-1501D (Process V Product)|"MYL-1501D (Process V Product)~MYL-1501D: Process V or Process VI"
10796545|NCT03376789|BG001|Baseline|MYL-1501D (Process VI Product)|"MYL-1501D (Process VI Product)~MYL-1501D: Process V or Process VI"
10796546|NCT03376789|BG002|Baseline|Total|Total of all reporting groups
10796547|NCT03376789|FG000|Participant Flow|MYL-1501D (Process V Product)|"MYL-1501D (Process V Product)~MYL-1501D: Process V or Process VI"
10796548|NCT03376789|FG001|Participant Flow|MYL-1501D (Process VI Product)|"MYL-1501D (Process VI Product)~MYL-1501D: Process V or Process VI"
10796549|NCT03376789|OG000|Outcome|MYL-1501D (Process V Product)|"MYL-1501D (Process V Product)~MYL-1501D: Process V or Process VI"
10796550|NCT03376789|OG001|Outcome|MYL-1501D (Process VI Product)|"MYL-1501D (Process VI Product)~MYL-1501D: Process V or Process VI"
10796551|NCT03376789|EG000|Reported Event|MYL-1501D (Process V Product)|"MYL-1501D (Process V Product)~MYL-1501D: Process V or Process VI"
10796552|NCT03376789|EG001|Reported Event|MYL-1501D (Process VI Product)|"MYL-1501D (Process VI Product)~MYL-1501D: Process V or Process VI"
10796553|NCT03342742|BG000|Baseline|Daily Caloric Restriction|"The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements.~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796554|NCT03342742|BG001|Baseline|Intermittent Fasting|"Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group).~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796555|NCT03342742|BG002|Baseline|Total|Total of all reporting groups
10796556|NCT03342742|FG000|Participant Flow|Daily Caloric Restriction|"The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements.~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796557|NCT03342742|FG001|Participant Flow|Intermittent Fasting|"Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group).~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796558|NCT03342742|OG000|Outcome|Overall Study|Pre-screened includes participants that were not randomized.
10796559|NCT03342742|OG000|Outcome|Overall Study (Screened)|Includes all participants screened, whether or not eventually enrolled into either study arm.
10796560|NCT03342742|OG000|Outcome|Daily Caloric Restriction|"The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements.~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796561|NCT03342742|OG001|Outcome|Intermittent Fasting|"Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group).~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796562|NCT03342742|EG000|Reported Event|Daily Caloric Restriction|"The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements.~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796563|NCT03342742|EG001|Reported Event|Intermittent Fasting|"Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group).~Weight Loss: Weight loss behavioral intervention via one of two strategies."
10796564|NCT03333590|BG000|Baseline|Cohort 1 (Minimal Efficacious Dose) rAAVrh74.MCK.GALGT2|"N = 3 [2.5 x E13 vg/kg per leg, delivered bilaterally (total 5.0 x E13 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796565|NCT03333590|BG001|Baseline|Cohort 2 (Dose Escalation) rAAVrh74.MCK.GALGT2|"N=3 [5 x E13 vg/kg per leg, delivered bilaterally (total 1.0 x E14 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796566|NCT03333590|BG002|Baseline|Total|Total of all reporting groups
10796567|NCT03333590|FG000|Participant Flow|Cohort 1 (Minimal Efficacious Dose) rAAVrh74.MCK.GALGT2|"N = 3 [2.5 x E13 vg/kg per leg, delivered bilaterally (total 5.0 x E13 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796568|NCT03333590|FG001|Participant Flow|Cohort 2 (Minimal Efficacious Dose) rAAVrh74.MCK.GALGT2|"N = 3 [5 x E13 vg/kg per leg, delivered bilaterally (total 1.0 x E14 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796569|NCT03333590|OG000|Outcome|Cohort 1 (Minimal Efficacious Dose)|"N = 1 [2.5 x E13 vg/kg per leg, delivered bilaterally (total 5.0 x E13 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796570|NCT03333590|OG001|Outcome|Cohort 2|"N = 1 [5 x E13 vg/kg per leg, delivered bilaterally (total 1.0 x E14 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796571|NCT03333590|OG001|Outcome|Cohort 2 (Minimal Efficacious Dose)|"N = 1 [5 x E13 vg/kg per leg, delivered bilaterally (total 1.0 x E14 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796572|NCT03333590|OG001|Outcome|Cohort 2|rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)
10796573|NCT03333590|EG000|Reported Event|Cohort 1 (Minimal Efficacious Dose) rAAVrh74.MCK.GALGT2|"N = 1 [2.5 x E13 vg/kg per leg, delivered bilaterally (total 5.0 x E13 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10796574|NCT03333590|EG001|Reported Event|Cohort 1 rAAVrh74.MCK.GALGT2|"N = 1 [5 x E13 vg/kg per leg, delivered bilaterally (total 1.0 x E14 vg/kg)]~rAAVrh74.MCK.GALGT2: Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)"
10803154|NCT02155647|FG000|Participant Flow|Part A: Avelumab|Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803155|NCT02155647|FG001|Participant Flow|Part B: Avelumab|Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803156|NCT02155647|OG000|Outcome|Part A: Avelumab|Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803157|NCT02155647|OG000|Outcome|Part B: Avelumab|Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803158|NCT02155647|EG000|Reported Event|Part A: Avelumab|Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803159|NCT02155647|EG001|Reported Event|Part B: Avelumab|Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
10803908|NCT01146652|OG000|Outcome|Sarilumab + DMARD: EFC11072 Part B|Participants who completed EFC11072 Part B were enrolled in LTS11210 and received sarilumab 150 mg SC qw. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
10803909|NCT01146652|OG000|Outcome|Sarilumab + DMARD: EFC11072, ACT11575 and EFC10832|Participants who completed any of the initial studies: Part A or Part B of EFC11072, ACT11575, and EFC10832 were enrolled in LTS11210 and received sarilumab 150 mg SC qw. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
11196088|NCT02162771|OG000|Outcome|CT-P10|"Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
10796575|NCT03307967|BG000|Baseline|SBIRT-PM|"Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.~SBIRT-PM: SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes."
10796576|NCT03307967|FG000|Participant Flow|SBIRT-PM|"Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.~SBIRT-PM: SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes."
10796577|NCT03307967|OG000|Outcome|SBIRT-PM|"Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.~SBIRT-PM: SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes."
10796578|NCT03307967|EG000|Reported Event|SBIRT-PM|"Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.~SBIRT-PM: SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes."
10796579|NCT03290326|BG000|Baseline|tACS|Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) was applied for 1 hour in 10 sessions on consecutive weekdays.
10796580|NCT03290326|FG000|Participant Flow|tACS|Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) was applied for 1 hour in 10 sessions on consecutive weekdays.
10796581|NCT03290326|OG000|Outcome|tACS|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid PET imaging as well as a clinical/cognitive evaluation. The assessment of adverse effects will constitute a Primary outcome measure. Changes in amyloid load in the stimulated brain region will be evaluated and constitute a secondary outcome of the study. Clinically relevant changes in cognitive and clinical scores will be also evaluated as secondary outcomes. Stimulation will be also preceded and followed by electroencephalography (EEG) recording aimed at assessing changes in spectral power in the gamma band.~tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10803164|NCT02032810|BG000|Baseline|Panobinostat 5 mg|Participants who received 5 mg of Panobinostat along with 3 mg Ipililumab
10803165|NCT02032810|BG001|Baseline|Panobinostat 10 mg|Participants who received 10 mg of Panobinostat along with 3 mg Ipililumab
10803166|NCT02032810|BG002|Baseline|Total|Total of all reporting groups
10796582|NCT03290326|OG000|Outcome|tACS 40Hz|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and cognitive function.~Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10796583|NCT03290326|OG000|Outcome|tACS|Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays.
10796584|NCT03290326|EG000|Reported Event|tACS|Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays.
10803167|NCT02032810|FG000|Participant Flow|Panobinostat 5 mg|Participants who received 5 mg of Panobinostat along with 3 mg Ipilimumab
11196089|NCT02162771|OG001|Outcome|Rituxan|"Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
11196090|NCT02162771|EG000|Reported Event|CT-P10|"Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
11196091|NCT02162771|EG001|Reported Event|Rituxan|"Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period."
11196092|NCT02162862|BG000|Baseline|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
11196093|NCT02162862|BG001|Baseline|Control Group|Individuals free of physical and psychiatric illness.
11196094|NCT02162862|BG002|Baseline|Behavioral Counseling + Bupropion|Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
11196095|NCT02162862|BG003|Baseline|Total|Total of all reporting groups
11196096|NCT02162862|FG000|Participant Flow|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
11196097|NCT02162862|FG001|Participant Flow|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling~Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
11196098|NCT02162862|FG002|Participant Flow|Behavioral Counseling + Bupropion|Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8 -week trial of bupropion-SR (target dose: 200-300mg/day). Bupropion-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement sleep (REM) in medically ill populations.
10803168|NCT02032810|FG001|Participant Flow|Panobinostat 10 mg|Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
10803169|NCT02032810|OG000|Outcome|Dose Escalation of Panobinostat, Plus Ipilimumab|Eligible participants with unresectable stage 3/4 MEL, up to 3 prior lines of therapy, and adequate laboratory values were treated with oral PAN 5 mg thrice weekly (TIW) plus IPI at 3 mg/kg IV every 3 weeks X 4 doses, followed by maintenance PAN until progression or intolerance. Using a modified Ji design, PAN dose escalation by 5 mg was planned in 3-12 participant cohorts up to a maximum dose of 20 mg TIW, without intra-participant dose escalation. Dose limiting toxicity (DLT) was assessed up to day 84 from start of therapy.
10803170|NCT02032810|OG000|Outcome|Panobinostat 5 mg|Participants who received 5 mg of Panobinostat along with 3 mg Ipilimumab
10803171|NCT02032810|OG001|Outcome|Panobinostat 10 mg|Participants who received Panobinostat 10 mg along with 3 mg Ipilimumab
10803172|NCT02032810|OG001|Outcome|Panobinostat 10 mg|Participants who received 10 mg of Panobinostat along with 3 mg of Ipilimumab
10803173|NCT02032810|OG000|Outcome|Panobinostat 5 mg|Participants who received 5 mg of Panobinostat along with 3 mg of Ipilimumab
10803174|NCT02032810|OG001|Outcome|Panobinostat 10 mg|Participants who received 10 mg Panobinostat along with 3 mg Ipilimumab
11196099|NCT02162862|OG000|Outcome|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling~Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
11196100|NCT02162862|OG001|Outcome|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
10796585|NCT03288129|BG000|Baseline|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
10796586|NCT03288129|FG000|Participant Flow|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 milligrams per day (mg/day) and were up-titrated in no less than 2-week intervals in increments of 2 milligram (mg) up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
10796587|NCT03288129|OG000|Outcome|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
10796588|NCT03288129|EG000|Reported Event|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
10803175|NCT02032810|EG000|Reported Event|Panobinostat 5 mg|Participants who received 5 mg of Panobinostat along with 3 mg Ipililumab
10803176|NCT02032810|EG001|Reported Event|Panobinostat 10 mg|Participants who received 10 mg of Panobinostat along with 3 mg Ipililumab
10803177|NCT01979211|BG000|Baseline|Cetuximab and Radiation|"Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions~Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7~Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab"
10803178|NCT01979211|FG000|Participant Flow|Cetuximab and Radiation|"Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions~Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7~Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab"
10803179|NCT01979211|OG000|Outcome|Cetuximab and Radiation|"Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions~Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7~Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab"
10803180|NCT01979211|EG000|Reported Event|Cetuximab and Radiation|"Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions~Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7~Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab"
10803181|NCT01904903|BG000|Baseline|HER2 Therapies, Cardiac Medications|"Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses~Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:~Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.~Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.~Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.~Trastuzumab: HER2 therapy~Pertuzumab: HER2 therapy~Ado Trastuzumab Emtansine: HER2 therapy"
10803182|NCT01904903|FG000|Participant Flow|HER2 Therapies, Cardiac Medications|"Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses~Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:~Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.~Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.~Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.~Trastuzumab: HER2 therapy~Pertuzumab: HER2 therapy~Ado Trastuzumab Emtansine: HER2 therapy"
10803183|NCT01904903|OG000|Outcome|HER2 Therapies, Cardiac Medications|"Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses~Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:~Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.~Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.~Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.~Trastuzumab: HER2 therapy~Pertuzumab: HER2 therapy~Ado Trastuzumab Emtansine: HER2 therapy"
10803184|NCT01904903|EG000|Reported Event|HER2 Therapies, Cardiac Medications|"Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses~Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:~Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.~Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.~Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.~Trastuzumab: HER2 therapy~Pertuzumab: HER2 therapy~Ado Trastuzumab Emtansine: HER2 therapy"
10803185|NCT01827384|BG000|Baseline|Treatment Assignment Code 1 (TAC1)|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10796589|NCT03272711|BG000|Baseline|Vortioxetine Plus Cognitive Training|"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day~Vortioxetine 10 mg~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796590|NCT03272711|BG001|Baseline|Placebo Plus Cognitive Training|"Placebo plus cognitive training 5 times weekly for 30 minutes a day~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796591|NCT03272711|BG002|Baseline|Total|Total of all reporting groups
10796592|NCT03272711|FG000|Participant Flow|Vortioxetine Plus Cognitive Training|"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day~Vortioxetine 10 mg~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796593|NCT03272711|FG001|Participant Flow|Placebo Plus Cognitive Training|"Placebo plus cognitive training 5 times weekly for 30 minutes a day~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796594|NCT03272711|OG000|Outcome|Vortioxetine Plus Cognitive Training|"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day~Vortioxetine 10 mg~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796595|NCT03272711|OG001|Outcome|Placebo Plus Cognitive Training|"Placebo plus cognitive training 5 times weekly for 30 minutes a day~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796596|NCT03272711|EG000|Reported Event|Vortioxetine Plus Cognitive Training|"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day~Vortioxetine 10 mg~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
10796597|NCT03272711|EG001|Reported Event|Placebo Plus Cognitive Training|"Placebo plus cognitive training 5 times weekly for 30 minutes a day~Cognitive training program: Online training program, 30 minutes a day, 5 times a week"
11241216|NCT02485561|BG001|Baseline|Screener Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
10796598|NCT03271983|BG000|Baseline|Topical Metronidazole|"Study session 1: metronidazole gel (RLD); followed by at least a one week washout period.~Study session 2: metronidazole gel (generic); followed by at least a one week washout period.~Study session 3: metronidazole cream (generic)"
10796599|NCT03271983|FG000|Participant Flow|Topical Metronidazole|"Study session 1: metronidazole gel (RLD); followed by at least a one week washout period.~Study session 2: metronidazole gel (generic); followed by at least a one week washout period.~Study session 3: metronidazole cream (generic)"
10796600|NCT03271983|OG000|Outcome|Study Session 1 (RLD Gel)|Metronidazole gel: RLD gel
10796601|NCT03271983|OG001|Outcome|Study Session 2 (Generic Gel)|Metronidazole gel: generic gel
10796602|NCT03271983|OG002|Outcome|Study Session 3 (Generic Cream)|Metronidazole cream: generic cream
10796603|NCT03271983|EG000|Reported Event|Study Session 1 (RLD Gel)|Metronidazole gel: RLD gel
10796604|NCT03271983|EG001|Reported Event|Study Session 2 (Generic Gel)|Metronidazole gel: generic gel
10796605|NCT03271983|EG002|Reported Event|Study Session 3 (Generic Cream)|Metronidazole cream: generic cream
10796606|NCT03246789|BG000|Baseline|Engage-M|"Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.~Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression."
10796607|NCT03246789|BG001|Baseline|Wellness in Mind and Body (W-MH)|"Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.~Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s."
10796608|NCT03246789|BG002|Baseline|Total|Total of all reporting groups
10796609|NCT03246789|FG000|Participant Flow|Engage-M|"Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.~Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression."
10796610|NCT03246789|FG001|Participant Flow|Wellness in Mind and Body (W-MH)|"Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.~Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s."
11337841|NCT03595280|OG001|Outcome|Untailored Messages|"Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
10796611|NCT03246789|OG000|Outcome|Engage-M|"Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.~Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression."
10796612|NCT03246789|OG001|Outcome|Wellness in Mind and Body (W-MH)|"Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.~Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s."
10796613|NCT03246789|EG000|Reported Event|Engage-M|"Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.~Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression."
10796614|NCT03246789|EG001|Reported Event|Wellness in Mind and Body (W-MH)|"Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.~Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s."
10803186|NCT01827384|BG001|Baseline|TAC1 -> TAC4|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803187|NCT01827384|BG002|Baseline|TAC2|TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803188|NCT01827384|BG003|Baseline|TAC2 -> TAC1|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803189|NCT01827384|BG004|Baseline|TAC2 -> TAC3|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803190|NCT01827384|BG005|Baseline|TAC3|TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803191|NCT01827384|BG006|Baseline|TAC3 -> TAC1|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803192|NCT01827384|BG007|Baseline|TAC3 -> TAC1 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803193|NCT01827384|BG008|Baseline|TAC3 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803194|NCT01827384|BG009|Baseline|TAC4|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803195|NCT01827384|BG010|Baseline|TAC4 -> TAC1|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803196|NCT01827384|BG011|Baseline|TAC4 -> TAC2|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803197|NCT01827384|BG012|Baseline|TAC4 -> TAC3|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803198|NCT01827384|BG013|Baseline|Participants Enrolled But Not Treated|Participants who signed consent and were enrolled but not treated.
10803199|NCT01827384|BG014|Baseline|Total|Total of all reporting groups
10803200|NCT01827384|FG000|Participant Flow|Treatment Assignment Code 1 (TAC1)|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
11196101|NCT02162862|OG002|Outcome|Behavioral Counseling + Bupropion|"8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
10796615|NCT03241225|BG000|Baseline|EM/PROTECT|"This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.~EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services"
10796616|NCT03241225|BG001|Baseline|EM/MH|"This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.~EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services."
10796617|NCT03241225|BG002|Baseline|Total|Total of all reporting groups
10796618|NCT03241225|FG000|Participant Flow|EM/PROTECT|"This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.~EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services"
10796619|NCT03241225|FG001|Participant Flow|EM/MH|"This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.~EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services."
10796620|NCT03241225|OG000|Outcome|EM/PROTECT|"This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.~EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services"
10796621|NCT03241225|OG001|Outcome|EM/MH|"This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.~EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services."
10796622|NCT03241225|EG000|Reported Event|EM/PROTECT|"This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.~EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services"
10796623|NCT03241225|EG001|Reported Event|EM/MH|"This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.~EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services."
10796624|NCT03225846|BG000|Baseline|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10796625|NCT03225846|BG001|Baseline|WVE-120102 (2 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796626|NCT03225846|BG002|Baseline|WVE-120102 (4 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796627|NCT03225846|BG003|Baseline|WVE-120102 (8 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796628|NCT03225846|BG004|Baseline|WVE-120102 (12 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796629|NCT03225846|BG005|Baseline|WVE-120102 (16 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796630|NCT03225846|BG006|Baseline|WVE-120102 (32 mg )|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796631|NCT03225846|BG007|Baseline|Total|Total of all reporting groups
10796632|NCT03225846|FG000|Participant Flow|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10796633|NCT03225846|FG001|Participant Flow|WVE-120102 (2 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796634|NCT03225846|FG002|Participant Flow|WVE-120102 (4 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796635|NCT03225846|FG003|Participant Flow|WVE-120102 (8 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796636|NCT03225846|FG004|Participant Flow|WVE-120102 (12 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796637|NCT03225846|FG005|Participant Flow|WVE-120102 (16 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796638|NCT03225846|FG006|Participant Flow|WVE-120102 (32 mg )|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796639|NCT03225846|OG000|Outcome|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10796640|NCT03225846|OG001|Outcome|WVE-120102 (2 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796641|NCT03225846|OG002|Outcome|WVE-120102 (4 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796642|NCT03225846|OG003|Outcome|WVE-120102 (8 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796643|NCT03225846|OG004|Outcome|WVE-120102 (12 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796644|NCT03225846|OG005|Outcome|WVE-120102 (16 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796645|NCT03225846|OG006|Outcome|WVE-120102 (32 mg )|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796646|NCT03225846|OG000|Outcome|WVE-120102 (2 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796647|NCT03225846|OG001|Outcome|WVE-120102 (4 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796648|NCT03225846|OG002|Outcome|WVE-120102 (8 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796649|NCT03225846|OG003|Outcome|WVE-120102 (12 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796650|NCT03225846|OG004|Outcome|WVE-120102 (16 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796651|NCT03225846|OG005|Outcome|WVE-120102 (32 mg )|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796652|NCT03225846|OG003|Outcome|WVE-120102 (12 mg)|WVE-12101: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796653|NCT03225846|EG000|Reported Event|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10796654|NCT03225846|EG001|Reported Event|WVE-120102 (2 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796655|NCT03225846|EG002|Reported Event|WVE-120102 (4 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796656|NCT03225846|EG003|Reported Event|WVE-120102 (8 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796657|NCT03225846|EG004|Reported Event|WVE-120102 (12 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796658|NCT03225846|EG005|Reported Event|WVE-120102 (16 mg)|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10796659|NCT03225846|EG006|Reported Event|WVE-120102 (32 mg )|WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
10803201|NCT01827384|FG001|Participant Flow|TAC1 -> TAC4|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803202|NCT01827384|FG002|Participant Flow|TAC2|TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803203|NCT01827384|FG003|Participant Flow|TAC2 -> TAC1|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803204|NCT01827384|FG004|Participant Flow|TAC2 -> TAC3|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803205|NCT01827384|FG005|Participant Flow|TAC3|TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803206|NCT01827384|FG006|Participant Flow|TAC3 -> TAC1|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803207|NCT01827384|FG007|Participant Flow|TAC3 -> TAC1 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803208|NCT01827384|FG008|Participant Flow|TAC3 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803209|NCT01827384|FG009|Participant Flow|TAC4|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803210|NCT01827384|FG010|Participant Flow|TAC4 -> TAC1|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803211|NCT01827384|FG011|Participant Flow|TAC4 -> TAC2|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803212|NCT01827384|FG012|Participant Flow|TAC4 -> TAC3|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803213|NCT01827384|FG013|Participant Flow|Participants Enrolled But Not Treated|Participants who signed consent and were enrolled but not treated.
10803214|NCT01827384|OG000|Outcome|Treatment Assignment Code 1 (TAC1)|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803215|NCT01827384|OG001|Outcome|TAC1 -> TAC4|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803216|NCT01827384|OG002|Outcome|TAC2|TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803217|NCT01827384|OG003|Outcome|TAC2 -> TAC1|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803218|NCT01827384|OG004|Outcome|TAC2 -> TAC3|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803219|NCT01827384|OG005|Outcome|TAC3|TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803220|NCT01827384|OG006|Outcome|TAC3 -> TAC1|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803221|NCT01827384|OG007|Outcome|TAC3 -> TAC1 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803222|NCT01827384|OG008|Outcome|TAC3 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803223|NCT01827384|OG009|Outcome|TAC4|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803224|NCT01827384|OG010|Outcome|TAC4 -> TAC1|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10796660|NCT03221270|BG000|Baseline|tACS Treatment & tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796661|NCT03221270|BG001|Baseline|Sham tACS Treatment & Sham tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796662|NCT03221270|BG002|Baseline|Sham tACS Treatment & tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796663|NCT03221270|BG003|Baseline|tACS Treatment & Sham tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796664|NCT03221270|BG004|Baseline|Total|Total of all reporting groups
10796665|NCT03221270|FG000|Participant Flow|tACS Treatment & tACS Maintenance|"10 Hz (alpha) transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796666|NCT03221270|FG001|Participant Flow|Sham tACS Treatment & Sham tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796667|NCT03221270|FG002|Participant Flow|Sham tACS Treatment & tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796668|NCT03221270|FG003|Participant Flow|tACS Treatment & Sham tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796669|NCT03221270|OG000|Outcome|tACS Treatment & tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796670|NCT03221270|OG001|Outcome|Sham tACS Treatment & Sham tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796671|NCT03221270|OG002|Outcome|Sham tACS Treatment & tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10803225|NCT01827384|OG011|Outcome|TAC4 -> TAC2|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10796672|NCT03221270|OG003|Outcome|tACS Treatment & Sham tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796673|NCT03221270|EG000|Reported Event|tACS Treatment & tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796674|NCT03221270|EG001|Reported Event|Sham tACS Treatment & Sham tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10796675|NCT03221270|EG002|Reported Event|Sham tACS Treatment & tACS Maintenance|"10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.~tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.~Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks."
10796676|NCT03221270|EG003|Reported Event|tACS Treatment & Sham tACS Maintenance|"10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.~tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.~Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks."
10803226|NCT01827384|OG012|Outcome|TAC4 -> TAC3|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803227|NCT01827384|OG013|Outcome|Participants Enrolled But Not Treated|Participants who signed consent and were enrolled but not treated.
10803228|NCT01827384|EG000|Reported Event|Treatment Assignment Code 1 (TAC1)|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803229|NCT01827384|EG001|Reported Event|TAC1 -> TAC4|TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803230|NCT01827384|EG002|Reported Event|TAC2|TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803231|NCT01827384|EG003|Reported Event|TAC2 -> TAC1|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803232|NCT01827384|EG004|Reported Event|TAC2 -> TAC3|TAC2: Everolimus 10 mg by mouth (PO) every day (QD) TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803233|NCT01827384|EG005|Reported Event|TAC3|TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803234|NCT01827384|EG006|Reported Event|TAC3 -> TAC1|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803235|NCT01827384|EG007|Reported Event|TAC3 -> TAC1 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5 TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803236|NCT01827384|EG008|Reported Event|TAC3 -> TAC4|TAC3: Trametinib 2mg by mouth (PO) every day (QD) TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803237|NCT01827384|EG009|Reported Event|TAC4|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1
10803238|NCT01827384|EG010|Reported Event|TAC4 -> TAC1|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC1: Veliparib (ABT-888) 40mg by mouth (PO) twice a day (BID) on days 1-7; Temozolomide 150 mg/m^2 PO every day (QD) on days 1-5
10803239|NCT01827384|EG011|Reported Event|TAC4 -> TAC2|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC2: Everolimus 10 mg by mouth (PO) every day (QD)
10803240|NCT01827384|EG012|Reported Event|TAC4 -> TAC3|TAC4: Adavosertib (MK-1775) 225 mg by mouth (PO) twice a day (BID) x 5 doses on days 1-3; Carboplatin area under the concentration (AUC) 5 intravenous (IV) over 30 min on day 1 TAC3: Trametinib 2mg by mouth (PO) every day (QD)
10803241|NCT01827384|EG013|Reported Event|Participants Enrolled But Not Treated|Participants who signed consent and were enrolled but not treated.
11196102|NCT02162862|OG000|Outcome|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
11196103|NCT02162862|OG002|Outcome|Behavioral Counseling + Bupropion|"Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.~bupropion-SR"
10796677|NCT03195088|BG000|Baseline|Placebo Matching BI 473494|Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
10796678|NCT03195088|BG001|Baseline|BI 473494 35 μg|Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796679|NCT03195088|BG002|Baseline|BI 473494 75 μg|Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796680|NCT03195088|BG003|Baseline|Total|Total of all reporting groups
10796681|NCT03195088|FG000|Participant Flow|Placebo Matching BI 473494|Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
10796682|NCT03195088|FG001|Participant Flow|BI 473494 35 μg|Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796683|NCT03195088|FG002|Participant Flow|BI 473494 75 μg|Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796684|NCT03195088|OG000|Outcome|Placebo Matching BI 473494|Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
10796685|NCT03195088|OG001|Outcome|BI 473494 35 μg|Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
11196104|NCT02162862|EG000|Reported Event|Healthy Control|The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
10796686|NCT03195088|OG002|Outcome|BI 473494 75 μg|Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796687|NCT03195088|OG000|Outcome|BI 473494 35 μg|Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796688|NCT03195088|OG001|Outcome|BI 473494 75 μg|Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796689|NCT03195088|EG000|Reported Event|Placebo Matching BI 473494|Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
10796690|NCT03195088|EG001|Reported Event|BI 473494 35 μg|Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796691|NCT03195088|EG002|Reported Event|BI 473494 75 μg|Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
10796692|NCT03191903|BG000|Baseline|Cingal|Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
10796693|NCT03191903|BG001|Baseline|Monovisc|Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
10796694|NCT03191903|BG002|Baseline|Triamcinolone Hexacetonide (TH)|Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
10796695|NCT03191903|BG003|Baseline|Total|Total of all reporting groups
10796696|NCT03191903|FG000|Participant Flow|Cingal|Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
10796697|NCT03191903|FG001|Participant Flow|Monovisc|Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
10796698|NCT03191903|FG002|Participant Flow|Triamcinolone Hexacetonide (TH)|Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
11196105|NCT02162862|EG001|Reported Event|Behavioral Counseling|"Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.~Behavioral Counseling"
11196106|NCT02162862|EG002|Reported Event|Behavioral Counseling + Bupropion|Participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). Bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
10796699|NCT03191903|OG000|Outcome|Cingal|Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
10796700|NCT03191903|OG001|Outcome|Monovisc|Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
10796701|NCT03191903|OG002|Outcome|Triamcinolone Hexacetonide (TH)|Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
10796702|NCT03191903|OG002|Outcome|Triamcinolone Hexacetonide (TH)|20 mg/ml supplied as 1 mL unit dose in a glass ampoule.
10796703|NCT03191903|OG002|Outcome|Triamcinolone Hexacetonide|Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
11196107|NCT02162992|BG000|Baseline|SLE and Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)~No intervention: Observational"
11196108|NCT02162992|BG001|Baseline|SLE Without Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)~No intervention: Observational"
11196109|NCT02162992|BG002|Baseline|Total|Total of all reporting groups
11196110|NCT02162992|FG000|Participant Flow|SLE and Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)~No intervention: Observational"
10796704|NCT03191903|OG000|Outcome|Cingal|"Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.~Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide"
10796705|NCT03191903|OG001|Outcome|Monovisc|"Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.~Monovisc: Hyaluronic acid"
10796706|NCT03191903|OG002|Outcome|Triamcinolone Hexacetonide (TH)|"Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.~Triamcinolone Hexacetonide: Triamcinolone Hexacetonide"
10796707|NCT03191903|EG000|Reported Event|Cingal|Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
10796708|NCT03191903|EG001|Reported Event|Monovisc|Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
10796709|NCT03191903|EG002|Reported Event|Triamcinolone Hexacetonide (TH)|Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
10803242|NCT01778946|BG000|Baseline|Nicotine|"Low Dose Nicotine (7mg) Moderate Dose Nicotine (14mg)~All participants in study will begin with the 7mg patch, titrating from 2 hours/day to a full 16 hours/day over the course of the first 7 days (based on individual tolerance).~Day 7 - Day 28 of the study, participants will apply a new nicotine patch daily. Depending on tolerance, some participants may increase to the moderate dose (14mg) patch.~All participants will apply a new patch daily for a total of 28 days (1 month)~Low Dose Nicotine (7mg)~Moderate Dose Nicotine (14mg)"
10803243|NCT01778946|FG000|Participant Flow|Nicotine|"Low Dose Nicotine (7mg) Moderate Dose Nicotine (14mg)~All participants in study will begin with the 7mg patch, titrating from 2 hours/day to a full 16 hours/day over the course of the first 7 days (based on individual tolerance).~Day 7 - Day 28 of the study, participants will apply a new nicotine patch daily. Depending on tolerance, some participants may increase to the moderate dose (14mg) patch.~All participants will apply a new patch daily for a total of 28 days (1 month)~Low Dose Nicotine (7mg)~Moderate Dose Nicotine (14mg)"
10803244|NCT01778946|OG000|Outcome|Nicotine|"Low Dose Nicotine (7mg) Moderate Dose Nicotine (14mg)~All participants in study will begin with the 7mg patch, titrating from 2 hours/day to a full 16 hours/day over the course of the first 7 days (based on individual tolerance).~Day 7 - Day 28 of the study, participants will apply a new nicotine patch daily. Depending on tolerance, some participants may increase to the moderate dose (14mg) patch.~All participants will apply a new patch daily for a total of 28 days (1 month)~Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)"
10803245|NCT01778946|EG000|Reported Event|Nicotine|"Low Dose Nicotine (7mg) Moderate Dose Nicotine (14mg)~All participants in study will begin with the 7mg patch, titrating from 2 hours/day to a full 16 hours/day over the course of the first 7 days (based on individual tolerance).~Day 7 - Day 28 of the study, participants will apply a new nicotine patch daily. Depending on tolerance, some participants may increase to the moderate dose (14mg) patch.~All participants will apply a new patch daily for a total of 28 days (1 month)~Low Dose Nicotine (7mg)~Moderate Dose Nicotine (14mg)"
10803246|NCT01636258|BG000|Baseline|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
10803247|NCT01636258|BG001|Baseline|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
10803248|NCT01636258|BG002|Baseline|Total|Total of all reporting groups
10803249|NCT01636258|FG000|Participant Flow|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
10803250|NCT01636258|FG001|Participant Flow|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
10803251|NCT01636258|OG000|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
10803252|NCT01636258|OG001|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
10803253|NCT01636258|OG001|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
10803254|NCT01636258|EG000|Reported Event|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
10803255|NCT01636258|EG001|Reported Event|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
10803256|NCT01597388|BG000|Baseline|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803257|NCT01597388|BG001|Baseline|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803258|NCT01597388|BG002|Baseline|75 mg QD Continuous|Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803259|NCT01597388|BG003|Baseline|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803260|NCT01597388|BG004|Baseline|125 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10796710|NCT03186794|BG000|Baseline|Aerobic Exercise Training (AET)|Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [(0.7 to 0.8 * peak heart rate - resting heart rate)+ resting heart rate]
10796711|NCT03186794|FG000|Participant Flow|Aerobic Exercise Training (AET)|Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [(0.7 to 0.8 * peak heart rate - resting heart rate)+ resting heart rate]
10796712|NCT03186794|OG000|Outcome|Aerobic Exercise Training (AET)|Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [0.7 to 0.8 * (peak heart rate - resting heart rate) + resting heart rate]
10796713|NCT03186794|OG000|Outcome|Aerobic Exercise Training (AET)|Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [(0.7 to 0.8 * peak heart rate - resting heart rate)+ resting heart rate]
10796714|NCT03186794|EG000|Reported Event|Aerobic Exercise Training (AET)|Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [(0.7 to 0.8 * peak heart rate - resting heart rate)+ resting heart rate]
10796715|NCT04289051|BG000|Baseline|Overall Participants|Subject disposition for all arms
10796716|NCT04289051|FG000|Participant Flow|HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse|"Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks.~First intervention: HYDRAL Oral Rinse Second intervention: Placebo Oral Rinse Third intervention: BIOTENE® Oral Rinse"
10796717|NCT04289051|FG001|Participant Flow|Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse|"Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of 2 weeks.~First intervention: Placebo Oral Rinse Second intervention: BIOTENE® Oral Rinse Third intervention: HYDRAL Oral Rinse"
10796718|NCT04289051|FG002|Participant Flow|BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse|"Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks.~First intervention: BIOTENE® Oral Rinse Second intervention: HYDRAL Oral Rinse Third intervention: Placebo Oral Rinse"
10796719|NCT04289051|OG000|Outcome|HYDRAL Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796720|NCT04289051|OG001|Outcome|Placebo Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796721|NCT04289051|OG002|Outcome|BIOTENE® Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796722|NCT04289051|EG000|Reported Event|HYDRAL Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796723|NCT04289051|EG001|Reported Event|Placebo Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796724|NCT04289051|EG002|Reported Event|BIOTENE® Oral Rinse|Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
10796725|NCT04210180|BG000|Baseline|Varenicline Plus E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. The FDA approved starter kit of varenicline will be provided to participants at V3 (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) along with additional G6 cartomizers. After the first week of varenicline, participants will receive the FDA-approved standard dose of varenicline (1 mg twice daily) and will continue to receive enough G6 cartomizers for the next 11 weeks.~Varenicline: 0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.~e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength."
10796726|NCT04210180|FG000|Participant Flow|Varenicline Plus E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. The FDA approved starter kit of varenicline will be provided to participants at V3 (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) along with additional G6 cartomizers. After the first week of varenicline, participants will receive the FDA-approved standard dose of varenicline (1 mg twice daily) and will continue to receive enough G6 cartomizers for the next 11 weeks.~Varenicline: 0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.~e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength."
10796727|NCT04210180|OG000|Outcome|Varenicline Plus E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. The FDA approved starter kit of varenicline will be provided to participants at V3 (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) along with additional G6 cartomizers. After the first week of varenicline, participants will receive the FDA-approved standard dose of varenicline (1 mg twice daily) and will continue to receive enough G6 cartomizers for the next 11 weeks.~Varenicline: 0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.~e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength."
10803261|NCT01597388|BG005|Baseline|125 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10796728|NCT04210180|EG000|Reported Event|Varenicline Plus E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. The FDA approved starter kit of varenicline will be provided to participants at V3 (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) along with additional G6 cartomizers. After the first week of varenicline, participants will receive the FDA-approved standard dose of varenicline (1 mg twice daily) and will continue to receive enough G6 cartomizers for the next 11 weeks.~Varenicline: 0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.~e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength."
10796729|NCT04097223|BG000|Baseline|COPD-FULL Sample|Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
10796730|NCT04097223|FG000|Participant Flow|COPD-FULL Sample|Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
10796731|NCT04097223|OG000|Outcome|COPD-12 - First Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date, who received first line therapy.
10796732|NCT04097223|OG001|Outcome|COPD-12 - Second Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date, who received second line therapy.
10796733|NCT04097223|OG002|Outcome|COPD-12 - Third Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date, who received third line therapy.
10796734|NCT04097223|OG003|Outcome|COPD-12 - Fourth Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date, who received fourth line therapy.
10796735|NCT04097223|OG000|Outcome|COPD-24 - First Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date, who received first line therapy.
10796736|NCT04097223|OG001|Outcome|COPD-24 - Second Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date, who received second line therapy.
10796737|NCT04097223|OG002|Outcome|COPD-24 - Third Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date, who received third line therapy.
10796738|NCT04097223|OG003|Outcome|COPD-24 - Fourth Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24), who received fourth line therapy.
10796739|NCT04097223|OG000|Outcome|COPD-36 - First Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received first line therapy.
10796740|NCT04097223|OG001|Outcome|COPD-36 - Second Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received second line therapy.
10796741|NCT04097223|OG002|Outcome|COPD-36 - Third Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received third line therapy.
10796742|NCT04097223|OG003|Outcome|COPD-36 - Fourth Line Therapy|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received fourth line therapy.
10796743|NCT04097223|OG000|Outcome|COPD-FULL Sample|Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
10796744|NCT04097223|OG001|Outcome|COPD-12 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date (COPD-12).
10796745|NCT04097223|OG002|Outcome|COPD-24 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date (COPD-24).
10796746|NCT04097223|OG003|Outcome|COPD-36 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36).
10796747|NCT04097223|OG000|Outcome|COPD-12 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date (COPD-12).
10796748|NCT04097223|OG000|Outcome|Overall COPD-sample|All observed patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database. Patients were censored in case of death or loss to follow-up.
10796749|NCT04097223|OG001|Outcome|COPD-24 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date (COPD-24).
10796750|NCT04097223|OG002|Outcome|COPD-36 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36).
10796751|NCT04097223|OG003|Outcome|COPD-12 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12).
11196111|NCT02162992|FG001|Participant Flow|SLE Without Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)~No intervention: Observational"
10796752|NCT04097223|OG003|Outcome|COPD-12 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12).
10796753|NCT04097223|OG004|Outcome|COPD-24 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
10796754|NCT04097223|OG005|Outcome|COPD-36 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
10796755|NCT04097223|OG003|Outcome|COPD-12 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date).
10796756|NCT04097223|OG003|Outcome|COPD-12 Patients With Available DMP-data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12).
10796757|NCT04097223|OG002|Outcome|COPD-36 Sample|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2014 and march 2019, with a follow-up of 36 months since index date (COPD-36).
10796758|NCT04097223|OG003|Outcome|COPD-12 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12).
10796759|NCT04097223|OG004|Outcome|COPD-24 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
10796760|NCT04097223|OG005|Outcome|COPD-36 Sample With DMP Data|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
10796761|NCT04097223|OG000|Outcome|COPD-FULL|Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
11196112|NCT02162992|OG000|Outcome|SLE and Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)~No intervention: Observational"
11196113|NCT02162992|OG001|Outcome|SLE Without Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)~No intervention: Observational"
10796762|NCT04097223|OG001|Outcome|COPD-12|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date (COPD-12).
10796763|NCT04097223|OG002|Outcome|COPD-24|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date (COPD-24).
10796764|NCT04097223|OG003|Outcome|COPD-36|Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36).
10796765|NCT04097223|EG000|Reported Event|COPD-FULL Sample|Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
10796766|NCT03675308|BG000|Baseline|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796767|NCT03675308|BG001|Baseline|Risankizumab|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796768|NCT03675308|BG002|Baseline|Total|Total of all reporting groups
10796769|NCT03675308|FG000|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
11196114|NCT02162992|EG000|Reported Event|SLE and Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)~No intervention: Observational"
10796770|NCT03675308|FG001|Participant Flow|Risankizumab|Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796771|NCT03675308|OG000|Outcome|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796772|NCT03675308|OG001|Outcome|Risankizumab|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796773|NCT03675308|EG000|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
10796774|NCT03675308|EG001|Reported Event|Risankizumab|Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
11196115|NCT02162992|EG001|Reported Event|SLE Without Anti-Ro Antibodies Group|"Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)~No intervention: Observational"
11196116|NCT02163057|BG000|Baseline|Cohort 1: Surgery Cohort|Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
10796775|NCT03573817|BG000|Baseline|Revefenacin + Formoterol|Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42).
10796776|NCT03573817|BG001|Baseline|Placebo + Formoterol|Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42).
10796777|NCT03573817|BG002|Baseline|Total|Total of all reporting groups
10796778|NCT03573817|FG000|Participant Flow|Revefenacin + Formoterol|Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42).
10796779|NCT03573817|FG001|Participant Flow|Placebo + Formoterol|Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42).
10796780|NCT03573817|OG000|Outcome|Period 1: Revefenacin + Formoterol (Sequential)|"Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.~."
10796781|NCT03573817|OG001|Outcome|Period 2: Revefenacin + Formoterol (Combo Solution)|Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
10796782|NCT03573817|OG002|Outcome|Period 1: Placebo + Formoterol (Sequential)|Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
10796783|NCT03573817|OG003|Outcome|Period 2: Placebo + Formoterol (Combo Solution)|Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
10796784|NCT03573817|OG000|Outcome|Period 1: Revefenacin + Formoterol (Sequential)|Days 1 to 21: Revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
10796785|NCT03573817|EG000|Reported Event|Period 1: Revefenacin + Formoterol (Sequential)|Days 1 to 21: Revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
10796786|NCT03573817|EG001|Reported Event|Period 2: Revefenacin + Formoterol (Combo Solution)|Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
10796787|NCT03573817|EG002|Reported Event|Period 1: Placebo + Formoterol (Sequential)|Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
10796788|NCT03573817|EG003|Reported Event|Period 2: Placebo + Formoterol (Combo Solution)|Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
10796789|NCT03318861|BG000|Baseline|Dose Escalation: 3 x 10^7 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796790|NCT03318861|BG001|Baseline|Dose Escalation: 1 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^8 3e7 transduced cells on Day 0.
10796791|NCT03318861|BG002|Baseline|Dose Escalation: 3 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^8 3e7 transduced cells on Day 0.
10796792|NCT03318861|BG003|Baseline|Dose Escalation: 1 x 10^9 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^9 3e7 transduced cells on Day 0.
10796793|NCT03318861|BG004|Baseline|Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585|RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min [Grade 2 chronic kidney disease]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 24 mg/m^2/day IV infusion for 3 days followed by single infusion of KITE-585 autologous anti-BCMA CAR T cells at a tolerable dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796794|NCT03318861|BG005|Baseline|Total|Total of all reporting groups
10796795|NCT03318861|FG000|Participant Flow|Dose Escalation: 3 x 10^7 KITE-585|Participants with relapsed/refractory multiple myeloma (RRMM), received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of KITE-585 autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells at a dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796796|NCT03318861|FG001|Participant Flow|Dose Escalation: 1 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^8 3e7 transduced cells on Day 0.
10796797|NCT03318861|FG002|Participant Flow|Dose Escalation: 3 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^8 3e7 transduced cells on Day 0.
10796798|NCT03318861|FG003|Participant Flow|Dose Escalation: 1 x 10^9 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^9 3e7 transduced cells on Day 0.
10803262|NCT01597388|BG006|Baseline|170 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11196117|NCT02163057|BG001|Baseline|Cohort 2: Chemoradiation|Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
11196118|NCT02163057|BG002|Baseline|Total|Total of all reporting groups
11196119|NCT02163057|FG000|Participant Flow|Cohort 1: Surgery Cohort|Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
11196120|NCT02163057|FG001|Participant Flow|Cohort 2: Chemoradiation|Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
11196121|NCT02163057|OG000|Outcome|Cohort 1: Surgery Cohort|Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
11196122|NCT02163057|OG001|Outcome|Cohort 2: Chemoradiation|Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
11196123|NCT02163057|OG000|Outcome|Cohort 1: Surgery Cohort|Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™ device.
11196124|NCT02163057|OG001|Outcome|Cohort 2: Chemoradiation|Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™ device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
11196125|NCT02163057|EG000|Reported Event|Cohort 1: Surgery Cohort|Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
11196126|NCT02163057|EG001|Reported Event|Cohort 2: Chemoradiation|Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
11196127|NCT02163226|BG000|Baseline|Arm 1: the Standard Hypofractionated Regimen (MFRT Group)|3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT)
11196128|NCT02163226|BG001|Baseline|Arm 2: Single-fraction Stereotactic Radiation (SBRT Group)|12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT
10796799|NCT03318861|FG004|Participant Flow|Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585|RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min [Grade 2 chronic kidney disease]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 24 mg/m^2/day IV infusion for 3 days followed by single infusion of KITE-585 autologous anti-BCMA CAR T cells at a tolerable dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796800|NCT03318861|OG000|Outcome|Dose Escalation: 3 x 10^7 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^7 3e7 transduced cells on Day 0.
11196129|NCT02163226|BG002|Baseline|Total|Total of all reporting groups
11196130|NCT02163226|FG000|Participant Flow|Arm 1: the Standard Hypofractionated Regimen (MFRT Group)|3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT)
11196131|NCT02163226|FG001|Participant Flow|Arm 2: Single-fraction Stereotactic Radiation (SBRT Group)|12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT
11196132|NCT02163226|OG000|Outcome|Arm 1: the Standard Hypofractionated Regimen (MFRT Group)|3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT)
11196133|NCT02163226|OG001|Outcome|Arm 2: Single-fraction Stereotactic Radiation (SBRT Group)|12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT
11196134|NCT02163226|EG000|Reported Event|Arm 1: the Standard Hypofractionated Regimen (MFRT Group)|3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT)
11196135|NCT02163226|EG001|Reported Event|Arm 2: Single-fraction Stereotactic Radiation (SBRT Group)|12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT
11196136|NCT02163421|BG000|Baseline|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
11196137|NCT02163421|BG001|Baseline|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196138|NCT02163421|BG002|Baseline|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196139|NCT02163421|BG003|Baseline|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196140|NCT02163421|BG004|Baseline|Total|Total of all reporting groups
11196141|NCT02163421|FG000|Participant Flow|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
11196142|NCT02163421|FG001|Participant Flow|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196143|NCT02163421|FG002|Participant Flow|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196144|NCT02163421|FG003|Participant Flow|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
10796801|NCT03318861|OG001|Outcome|Dose Escalation: 1 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^8 3e7 transduced cells on Day 0.
10796802|NCT03318861|OG002|Outcome|Dose Escalation: 3 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^8 3e7 transduced cells on Day 0.
10796803|NCT03318861|OG003|Outcome|Dose Escalation: 1 x 10^9 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^9 3e7 transduced cells on Day 0.
10796804|NCT03318861|OG004|Outcome|Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585|RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min [Grade 2 chronic kidney disease]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 24 mg/m^2/day IV infusion for 3 days followed by single infusion of KITE-585 autologous anti-BCMA CAR T cells at a tolerable dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796805|NCT03318861|EG000|Reported Event|Dose Escalation: 3 x 10^7 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^7 3e7 transduced cells on Day 0.
10796806|NCT03318861|EG001|Reported Event|Dose Escalation: 1 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^8 3e7 transduced cells on Day 0.
10796807|NCT03318861|EG002|Reported Event|Dose Escalation: 3 x 10^8 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 3 x 10^8 3e7 transduced cells on Day 0.
10796808|NCT03318861|EG003|Reported Event|Dose Escalation: 1 x 10^9 KITE-585|Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 30 mg/m^2/day IV infusion for 3 days followed by a single infusion of KITE-585 autologous anti-BCMA CAR T cells at a dose of 1 x 10^9 3e7 transduced cells on Day 0.
10796809|NCT03318861|EG004|Reported Event|Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585|RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min [Grade 2 chronic kidney disease]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m^2/day and fludarabine 24 mg/m^2/day IV infusion for 3 days followed by single infusion of KITE-585 autologous anti-BCMA CAR T cells at a tolerable dose of 3 x 10^7 3e7 transduced cells on Day 0.
10803263|NCT01597388|BG007|Baseline|170 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803264|NCT01597388|BG008|Baseline|125 mg BID Intermittent Days 1 and 4 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803265|NCT01597388|BG009|Baseline|Total|Total of all reporting groups
10803266|NCT01597388|FG000|Participant Flow|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803267|NCT01597388|FG001|Participant Flow|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803268|NCT01597388|FG002|Participant Flow|75 mg QD Continuous|Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803269|NCT01597388|FG003|Participant Flow|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803270|NCT01597388|FG004|Participant Flow|125 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803271|NCT01597388|FG005|Participant Flow|125 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803272|NCT01597388|FG006|Participant Flow|170 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803273|NCT01597388|FG007|Participant Flow|170 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803274|NCT01597388|FG008|Participant Flow|125 mg BID Intermittent Days 1 and 4 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803275|NCT01597388|OG000|Outcome|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11383672|NCT01619085|EG007|Reported Event|Total (1199.32/.34/.35/.187)|For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
11383673|NCT01499095|BG000|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
11383674|NCT01499095|BG001|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
11383675|NCT01499095|BG002|Baseline|Total|Total of all reporting groups
11383676|NCT01499095|FG000|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
11383677|NCT01499095|FG001|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
11383678|NCT01499095|OG000|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
10796810|NCT03170349|BG000|Baseline|Edwards PASCAL Transcatheter Mitral Valve Repair System|Mitral valve repair with PASCAL implanted via transcatheter procedure
10796811|NCT03170349|FG000|Participant Flow|Edwards PASCAL Transcatheter Mitral Valve Repair System|Mitral valve repair with PASCAL implanted via transcatheter procedure
11196145|NCT02163421|OG000|Outcome|Vedolizumab Subcutaneous|Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11383679|NCT01499095|OG001|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
11383680|NCT01499095|OG001|Outcome|Lantus|Lantus SC injection once daily for 12 months on in combination with antidiabetic drug(s).
11383681|NCT01499095|OG000|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
11383682|NCT01499095|OG001|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
11383683|NCT01499095|EG000|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
11383684|NCT01499095|EG001|Reported Event|LANTUS|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
11383685|NCT01499082|BG000|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
11383686|NCT01499082|BG001|Baseline|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
11383687|NCT01499082|BG002|Baseline|Total|Total of all reporting groups
11383688|NCT01499082|FG000|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.
11383689|NCT01499082|FG001|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
10796812|NCT03170349|OG000|Outcome|Edwards PASCAL Transcatheter Mitral Valve Repair System|Mitral valve repair with PASCAL implanted via transcatheter procedure
10796813|NCT03170349|EG000|Reported Event|Edwards PASCAL Transcatheter Mitral Valve Repair System|Multi-center, prospective study with intra-subject comparisons
10796814|NCT03119064|BG000|Baseline|Dose 1|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 1 50mg/m2 IV every 2 weeks"
11196146|NCT02163421|EG000|Reported Event|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
11196147|NCT02163421|EG001|Reported Event|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196148|NCT02163421|EG002|Reported Event|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11383690|NCT01499082|OG000|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
11383691|NCT01499082|OG001|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
11383692|NCT01499082|OG000|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
11383693|NCT01499082|OG001|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
11383694|NCT01499082|EG000|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
11383695|NCT01499082|EG001|Reported Event|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
10796815|NCT03119064|BG001|Baseline|Dose 2|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 2 70 mg/m2 IV every 2 weeks"
10796816|NCT03119064|BG002|Baseline|Total|Total of all reporting groups
10796817|NCT03119064|FG000|Participant Flow|Dose 1|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 1 50mg/m2 IV every 2 weeks"
10796818|NCT03119064|FG001|Participant Flow|Dose 2|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 2 70 mg/m2 IV every 2 weeks"
10796819|NCT03119064|FG002|Participant Flow|Dose 3|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 3 80mg/m2 IV every 2 weeks"
10796820|NCT03119064|OG000|Outcome|All Participants|"Temozolomide: until disease progression.~Nanoliposomal irinotecan : IV every 2 weeks"
10796821|NCT03119064|OG000|Outcome|Dose 1|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 1 50mg/m2 IV every 2 weeks"
10796822|NCT03119064|OG001|Outcome|Dose 2|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 2 70 mg/m2 IV every 2 weeks"
10796823|NCT03119064|EG000|Reported Event|Dose 1|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 1 50mg/m2 IV every 2 weeks"
10796824|NCT03119064|EG001|Reported Event|Dose 2|"Temozolomide: 50mg/m2/day until disease progression.~Nanoliposomal irinotecan :~Dose Level 2 70 mg/m2 IV every 2 weeks"
10796825|NCT03095456|BG000|Baseline|Revefenacin|"Active Revefenacin and placebo (in place of Spiriva Handihaler®)~Revefenacin: Revefenacin administered via nebulization.~Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®."
10796826|NCT03095456|BG001|Baseline|Spiriva Handihaler®|"Active Spiriva Handihaler® and placebo (in place of Revefenacin)~Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.~Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization."
10796827|NCT03095456|BG002|Baseline|Total|Total of all reporting groups
10796828|NCT03095456|FG000|Participant Flow|Revefenacin|"Active Revefenacin and placebo (in place of Spiriva Handihaler®)~Revefenacin: Revefenacin administered via nebulization.~Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®."
10796829|NCT03095456|FG001|Participant Flow|Spiriva Handihaler®|"Active Spiriva Handihaler® and placebo (in place of Revefenacin)~Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.~Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization."
10796830|NCT03095456|OG000|Outcome|Revefenacin|"Active Revefenacin and placebo (in place of Spiriva Handihaler®)~Revefenacin: Revefenacin administered via nebulization.~Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®."
10796831|NCT03095456|OG001|Outcome|Spiriva Handihaler®|"Active Spiriva Handihaler® and placebo (in place of Revefenacin)~Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.~Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization."
10796832|NCT03095456|EG000|Reported Event|Revefenacin|"Active Revefenacin and placebo (in place of Spiriva Handihaler®)~Revefenacin: Revefenacin administered via nebulization.~Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®."
10796833|NCT03095456|EG001|Reported Event|Spiriva Handihaler®|"Active Spiriva Handihaler® and placebo (in place of Revefenacin)~Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.~Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization."
10796834|NCT03064113|BG000|Baseline|Sequence 1|"Intervention 1 (Placebo) - [2 days], washout [7 days],~Intervention 2 (TD-4208 700 μg) - [2 days], washout [7 days],~Intervention 3 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 4 (Ipratropium 500 μg) - [2 days], washout [7 days]"
10796835|NCT03064113|BG001|Baseline|Sequence 2|"Intervention 1 (TD-4208 700 μg) - [2 days], washout [7 days],~Intervention 2 (Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 3 (Placebo) - [2 days], washout [7 days],~Intervention 4 (TD-4208 350 μg) - [2 days], washout [7 days]"
10796836|NCT03064113|BG002|Baseline|Sequence 3|"Intervention 1 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 2 (Placebo) - [2 days], washout [7 days],~Intervention 3 (Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 4 (TD-4208 700 μg) - [2 days], washout [7 days]"
10796837|NCT03064113|BG003|Baseline|Sequence 4|"Intervention 1 (Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 2 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 3 (TD-4208 700 μg) - [2 days], washout [7 days],~Intervention 4 (Placebo) - [2 days], washout [7 days]"
10796838|NCT03064113|BG004|Baseline|Total|Total of all reporting groups
10796839|NCT03064113|FG000|Participant Flow|Sequence 1|"Intervention 1 (Placebo) - [2 days], washout [7 days],~Intervention 2 (TD4208 700 μg) - [2 days], washout [7 days],~Intervention 3 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 4 (Ipratropium 500 μg) - [2 days], washout [7 days]"
10796840|NCT03064113|FG001|Participant Flow|Sequence 2|"Intervention 1 (TD-4208 700 μg) - [2 days], washout [7 days],~Intervention 2 (Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 3 (Placebo) - [2 days], washout [7 days],~Intervention 4 (TD-4208 350 μg) - [2 days], washout [7 days]"
10796841|NCT03064113|FG002|Participant Flow|Sequence 3|"Intervention 1 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 2 (Placebo) - [2 days], washout [7 days],~Intervention 3 (Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 4 (TD-4208 700 μg) - [2 days], washout [7 days]"
10796842|NCT03064113|FG003|Participant Flow|Sequence 4|"Intervention 1(Ipratropium 500 μg) - [2 days], washout [7 days],~Intervention 2 (TD-4208 350 μg) - [2 days], washout [7 days],~Intervention 3 (TD-4208 700 μg) - [2 days], washout [7 days],~Intervention 4 (Placebo) - [2 days], washout [7 days]"
10796843|NCT03064113|OG000|Outcome|Placebo|Single dose of placebo administered via nebulizer
10796844|NCT03064113|OG001|Outcome|TD-4208 700 μg|Single dose of TD-4208 700 μg administered via nebulizer
10796845|NCT03064113|OG002|Outcome|TD-4208 350 μg|Single dose of TD-4208 350 μg administered via nebulizer
10796846|NCT03064113|OG003|Outcome|Ipratropium 500 μg|Single dose of Ipratropium 500 μg administered via nebulizer
10796847|NCT03064113|EG000|Reported Event|Placebo|Single dose of placebo administered via nebulizer
10796848|NCT03064113|EG001|Reported Event|TD-4208 700 μg|Single dose of TD-4208 700 μg administered via nebulizer
10796849|NCT03064113|EG002|Reported Event|TD-4208 350 μg|Single dose of TD-4208 350 μg administered via nebulizer
10796850|NCT03064113|EG003|Reported Event|Ipratropium 500 μg|Single dose of Ipratropium 500 μg administered via nebulizer
10796851|NCT02938013|BG000|Baseline|Group A|Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
10796852|NCT02938013|BG001|Baseline|Group B|Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796853|NCT02938013|BG002|Baseline|Group C|HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796854|NCT02938013|BG003|Baseline|Total|Total of all reporting groups
10796855|NCT02938013|FG000|Participant Flow|Group A|Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
10796856|NCT02938013|FG001|Participant Flow|Group B|Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796857|NCT02938013|FG002|Participant Flow|Group C|HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796858|NCT02938013|OG000|Outcome|Group A|Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
10796859|NCT02938013|OG001|Outcome|Group B|Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796860|NCT02938013|OG002|Outcome|Group C|HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796861|NCT02938013|EG000|Reported Event|Group A|Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
10796862|NCT02938013|EG001|Reported Event|Group B|Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796863|NCT02938013|EG002|Reported Event|Group C|HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
10796864|NCT02919683|BG000|Baseline|Nivolumab With Ipilimumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Ipilimumab to be delivered at a pre-determine dose for one week~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Ipilimumab~Standard of Care Surgery"
10796865|NCT02919683|BG001|Baseline|Nivolumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Standard of Care Surgery"
10796866|NCT02919683|BG002|Baseline|Total|Total of all reporting groups
10796867|NCT02919683|FG000|Participant Flow|Nivolumab With Ipilimumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Ipilimumab to be delivered at a pre-determine dose for one week~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Ipilimumab~Standard of Care Surgery"
10796868|NCT02919683|FG001|Participant Flow|Nivolumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Standard of Care Surgery"
10796869|NCT02919683|OG000|Outcome|Nivolumab With Ipilimumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Ipilimumab to be delivered at a pre-determine dose for one week~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Ipilimumab~Standard of Care Surgery"
10796870|NCT02919683|OG001|Outcome|Nivolumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Standard of Care Surgery"
10796871|NCT02919683|OG000|Outcome|All Participants|All participants enrolled in both trial cohorts.
10796872|NCT02919683|EG000|Reported Event|Nivolumab With Ipilimumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Ipilimumab to be delivered at a pre-determine dose for one week~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Ipilimumab~Standard of Care Surgery"
10796873|NCT02919683|EG001|Reported Event|Nivolumab|"Nivolumab to be delivered at a pre-determine dose for two weeks~Blood Sample Collected~Standard of Care Surgery~Nivolumab~Standard of Care Surgery"
10803276|NCT01597388|OG001|Outcome|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11196149|NCT02163421|EG003|Reported Event|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
11196150|NCT02163434|BG000|Baseline|Gabapentin|"1800-2400mg/day divided tid or qid, orally.~Gabapentin"
10803277|NCT01597388|OG002|Outcome|75 mg QD Continuous|Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803278|NCT01597388|OG003|Outcome|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11196151|NCT02163434|BG001|Baseline|Metoclopramide|"45-60mg/day divided tid or qid, orally~Metoclopramide"
11196152|NCT02163434|BG002|Baseline|Total|Total of all reporting groups
11196153|NCT02163434|FG000|Participant Flow|Gabapentin|"1800-2400mg/day divided tid or qid, orally.~Gabapentin"
10796874|NCT02901548|BG000|Baseline|Durvalumab Plus Cystoscopy|"Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase.~Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.~Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy."
10796875|NCT02901548|FG000|Participant Flow|Durvalumab Plus Cystoscopy|"Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase.~Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.~Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy."
10796876|NCT02901548|OG000|Outcome|Durvalumab Plus Cystoscopy|"Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase.~Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.~Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy."
10796877|NCT02901548|EG000|Reported Event|Durvalumab Plus Cystoscopy|"Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase.~Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.~Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy."
10796878|NCT02790138|BG000|Baseline|Placebo IV|Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
11196154|NCT02163434|FG001|Participant Flow|Metoclopramide|"45-60mg/day divided tid or qid, orally~Metoclopramide"
11196155|NCT02163434|OG000|Outcome|Gabapentin|"1800-2400mg/day divided tid or qid, orally.~Gabapentin"
11196156|NCT02163434|OG001|Outcome|Metoclopramide|"45-60mg/day divided tid or qid, orally~Metoclopramide"
11196157|NCT02163434|EG000|Reported Event|Gabapentin|"1800-2400mg/day divided tid or qid, orally.~Gabapentin"
11196158|NCT02163434|EG001|Reported Event|Metoclopramide|"45-60mg/day divided tid or qid, orally~Metoclopramide"
11196159|NCT02163447|BG000|Baseline|Mothers - 3 Dose SP|Sulfadoxine-Pyrimethamine 500mg/25mg
11196160|NCT02163447|BG001|Baseline|Mothers - 3 Dose DP|Dihydrioartemisinin-Piperaquine 40mg/320mg
11196161|NCT02163447|BG002|Baseline|Mothers - Monthly DP|Dihydroartemisinin-Piperaquine 20mg/160mg
11196162|NCT02163447|BG003|Baseline|Total|Total of all reporting groups
11196163|NCT02163447|FG000|Participant Flow|Mothers - 3 Dose SP|Sulfadoxine-Pyrimethamine 500mg/25mg
11196164|NCT02163447|FG001|Participant Flow|Mothers - 3 Dose DP|Dihydrioartemisinin-Piperaquine 40mg/320mg
11196165|NCT02163447|FG002|Participant Flow|Mothers - Monthly DP|Dihydroartemisinin-Piperaquine 20mg/160mg
11202265|NCT02206685|BG001|Baseline|Control Group|"The control group will receive a 20 ml normal saline placebo infusion over 10 minutes~Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes"
11202266|NCT02206685|BG002|Baseline|Total|Total of all reporting groups
11202267|NCT02206685|FG000|Participant Flow|Treatment Group|"The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.~Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes"
10796879|NCT02790138|BG001|Baseline|Vedolizumab IV 300 mg|Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796880|NCT02790138|BG002|Baseline|Total|Total of all reporting groups
10796881|NCT02790138|FG000|Participant Flow|Placebo IV|Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796882|NCT02790138|FG001|Participant Flow|Vedolizumab IV 300 mg|Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796883|NCT02790138|OG000|Outcome|Placebo IV|Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796884|NCT02790138|OG001|Outcome|Vedolizumab IV 300 mg|Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796885|NCT02790138|OG000|Outcome|Placebo IV|Vedolizumab placebo-matching intravenous (IV) infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796886|NCT02790138|EG000|Reported Event|Placebo IV|Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796887|NCT02790138|EG001|Reported Event|Vedolizumab IV 300 mg|Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
10796888|NCT02642315|BG000|Baseline|Open-label|"open-label single arm study~Horizant, 600 mg oral once daily at 5 pm for 360 days.~Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."
10796889|NCT02642315|FG000|Participant Flow|Open-label|"open-label single arm study~Horizant, 600 mg oral once daily at 5 pm for 360 days.~Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."
10796890|NCT02642315|OG000|Outcome|Open-label|"open-label single arm study~Horizant, 600 mg oral once daily at 5 pm for 360 days.~Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."
11196166|NCT02163447|OG000|Outcome|Mothers - 3 Dose SP|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.~3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy~3-monthly dihydroartemisinin-piperaquine (DP) for infants"
10796891|NCT02642315|EG000|Reported Event|Open-label|"open-label single arm study~Horizant, 600 mg oral once daily at 5 pm for 360 days.~Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."
10796892|NCT02518139|BG000|Baseline|TD-4208-1|"88 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
10796893|NCT02518139|BG001|Baseline|TD-4208-2|"175 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
10796894|NCT02518139|BG002|Baseline|Tiotropium|"18 mcg~Tiotropium: Active comparator"
10796895|NCT02518139|BG003|Baseline|Total|Total of all reporting groups
10796896|NCT02518139|FG000|Participant Flow|TD-4208-1|"88 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
11202268|NCT02206685|FG001|Participant Flow|Control Group|"The control group will receive a 20 ml normal saline placebo infusion over 10 minutes~Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes"
11202269|NCT02206685|OG000|Outcome|Treatment Group|"The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.~Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes"
11196167|NCT02163447|OG001|Outcome|Mothers - 3 Dose DP|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.~3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~3-monthly dihydroartemisinin-piperaquine (DP) for infants"
11196168|NCT02163447|OG002|Outcome|Mothers - Monthly DP|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age.~3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11196169|NCT02163447|OG000|Outcome|Mothers - 3 Dose SP|Sulfadoxine-Pyrimethamine 500mg/25mg
11196170|NCT02163447|OG001|Outcome|Mothers - 3 Dose DP|Dihydrioartemisinin-Piperaquine 40mg/320mg
10796897|NCT02518139|FG001|Participant Flow|TD-4208-2|"175 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
10796898|NCT02518139|FG002|Participant Flow|Tiotropium|"18 mcg~Tiotropium: Active comparator"
10796899|NCT02518139|OG000|Outcome|TD-4208-1|"88 mcg~TD-4208"
10796900|NCT02518139|OG001|Outcome|TD-4208-2|"175 mcg~TD-4208"
10796901|NCT02518139|OG002|Outcome|Tiotropium|"18 mcg~Tiotropium: Active comparator"
10796902|NCT02518139|EG000|Reported Event|TD-4208-1|"88 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
10796903|NCT02518139|EG001|Reported Event|TD-4208-2|"175 mcg~TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium."
10796904|NCT02518139|EG002|Reported Event|Tiotropium|"18 mcg~Tiotropium: Active comparator"
10796905|NCT02514239|BG000|Baseline|Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)|Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796906|NCT02514239|BG001|Baseline|Intravenous Infusion of BI 836909 (3.2 μg/d)|Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796907|NCT02514239|BG002|Baseline|Intravenous Infusion of BI 836909 (6.5 μg/d)|Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796908|NCT02514239|BG003|Baseline|Intravenous Infusion of BI 836909 (13 μg/d)|Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796909|NCT02514239|BG004|Baseline|Intravenous Infusion of BI 836909 (25 μg/d)|Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796910|NCT02514239|BG005|Baseline|Intravenous Infusion of BI 836909 (50 μg/d)|Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796911|NCT02514239|BG006|Baseline|Intravenous Infusion of BI 836909 (100 μg/d)|Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796912|NCT02514239|BG007|Baseline|Intravenous Infusion of BI 836909 (200 μg/d)|Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796913|NCT02514239|BG008|Baseline|Intravenous Infusion of BI 836909 (400 μg/d)|Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796914|NCT02514239|BG009|Baseline|Intravenous Infusion of BI 836909 (800 μg/d)|Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796915|NCT02514239|BG010|Baseline|Total|Total of all reporting groups
10796916|NCT02514239|FG000|Participant Flow|Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)|Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796917|NCT02514239|FG001|Participant Flow|Intravenous Infusion of BI 836909 (3.2 μg/d)|Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796918|NCT02514239|FG002|Participant Flow|Intravenous Infusion of BI 836909 (6.5 μg/d)|Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796919|NCT02514239|FG003|Participant Flow|Intravenous Infusion of BI 836909 (13 μg/d)|Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796920|NCT02514239|FG004|Participant Flow|Intravenous Infusion of BI 836909 (25 μg/d)|Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796921|NCT02514239|FG005|Participant Flow|Intravenous Infusion of BI 836909 (50 μg/d)|Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796922|NCT02514239|FG006|Participant Flow|Intravenous Infusion of BI 836909 (100 μg/d)|Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796923|NCT02514239|FG007|Participant Flow|Intravenous Infusion of BI 836909 (200 μg/d)|Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796924|NCT02514239|FG008|Participant Flow|Intravenous Infusion of BI 836909 (400 μg/d)|Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796925|NCT02514239|FG009|Participant Flow|Intravenous Infusion of BI 836909 (800 μg/d)|Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
11196171|NCT02163447|OG002|Outcome|Mothers - Monthly DP|Dihydroartemisinin-Piperaquine 20mg/160mg
11383696|NCT01496976|BG000|Baseline|Immunotherapy|"Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide~High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.~Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment."
11383697|NCT01496976|FG000|Participant Flow|Immunotherapy|"Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide~High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.~Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment."
11383698|NCT01496976|OG000|Outcome|Immunotherapy|"Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide~High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.~Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment."
11383699|NCT01496976|EG000|Reported Event|Immunotherapy|"Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide~High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.~Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP.~Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment."
11383700|NCT01488890|BG000|Baseline|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
11383701|NCT01488890|BG001|Baseline|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
11383702|NCT01488890|BG002|Baseline|CYD Dengue and Yellow Fever Vaccine: Group 3|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
11383703|NCT01488890|BG003|Baseline|Yellow Fever Vaccine: Group 4|Participants received single dose of YF vaccine at Day 0.
11383704|NCT01488890|BG004|Baseline|Total|Total of all reporting groups
11383705|NCT01488890|FG000|Participant Flow|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
11383706|NCT01488890|FG001|Participant Flow|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
11383707|NCT01488890|FG002|Participant Flow|CYD Dengue and Yellow Fever (YF) Vaccine: Group 3|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
11383708|NCT01488890|FG003|Participant Flow|Yellow Fever Vaccine: Group 4|Participants received single dose of YF vaccine at Day 0.
11383709|NCT01488890|OG000|Outcome|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
11383710|NCT01488890|OG001|Outcome|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
11383711|NCT01488890|OG000|Outcome|CYD Dengue Vaccine Group 1 and 2: Pooled|All Participants who received 3 doses of CYD dengue vaccine in Group 1 and 2.
11383712|NCT01488890|OG001|Outcome|CYD Dengue and Yellow Fever Vaccine: Group 3|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
11383713|NCT01488890|OG000|Outcome|CYD Dengue Vaccine Group 1 and Group 2: Pooled|All participants who received 3 doses of CYD dengue vaccine in Group 1 and Group 2.
11383714|NCT01488890|OG002|Outcome|CYD Dengue and Yellow Fever Vaccine: Group 3|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
11383715|NCT01488890|OG000|Outcome|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine ; one each at 0, 6 and 12 months.
11383716|NCT01488890|OG003|Outcome|Yellow Fever Vaccine: Group 4|Participants received single dose of YF vaccine at Day 0.
11383717|NCT01488890|EG000|Reported Event|CYD Dengue Vaccine: Group 1|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
11383718|NCT01488890|EG001|Reported Event|CYD Dengue Vaccine: Group 2|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
11383719|NCT01488890|EG002|Reported Event|CYD Dengue and Yellow Fever Vaccine: Group 3|Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
11383720|NCT01488890|EG003|Reported Event|Yellow Fever Vaccine: Group 4|Participants received single dose of YF vaccine at Day 0.
11383721|NCT01436396|BG000|Baseline|CYD Dengue Vaccine Group|Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383722|NCT01436396|BG001|Baseline|Placebo Group|Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383723|NCT01436396|BG002|Baseline|Total|Total of all reporting groups
11383724|NCT01436396|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received the Stamaril® and the CYD dengue vaccine (Injection [Inj.] 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383725|NCT01436396|FG001|Participant Flow|Placebo Group|Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383726|NCT01436396|OG000|Outcome|CYD Dengue Vaccine Group|Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383727|NCT01436396|OG001|Outcome|Placebo Group|Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383728|NCT01436396|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383729|NCT01436396|EG001|Reported Event|Placebo Group|Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
11383730|NCT01411241|BG000|Baseline|CYD Dengue Vaccine Group 1|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383731|NCT01411241|BG001|Baseline|CYD Dengue Vaccine Group 2|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383732|NCT01411241|BG002|Baseline|Total|Total of all reporting groups
11383733|NCT01411241|FG000|Participant Flow|CYD Dengue Vaccine Group 1|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383734|NCT01411241|FG001|Participant Flow|CYD Dengue Vaccine Group 2|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383735|NCT01411241|OG000|Outcome|CYD Dengue Vaccine Group 1|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383736|NCT01411241|OG001|Outcome|CYD Dengue Vaccine Group 2|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383737|NCT01411241|EG000|Reported Event|CYD Dengue Vaccine Group 1|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383738|NCT01411241|EG001|Reported Event|CYD Dengue Vaccine Group 2|Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
11383739|NCT01374516|BG000|Baseline|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383740|NCT01374516|BG001|Baseline|Placebo Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383741|NCT01374516|BG002|Baseline|Total|Total of all reporting groups
10796926|NCT02514239|OG000|Outcome|Intravenous Infusion of BI 836909 (Total Dose Escalation)|BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
10796927|NCT02514239|OG000|Outcome|Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)|Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796928|NCT02514239|OG001|Outcome|Intravenous Infusion of BI 836909 (3.2 μg/d)|Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796929|NCT02514239|OG002|Outcome|Intravenous Infusion of BI 836909 (6.5 μg/d)|Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796930|NCT02514239|OG003|Outcome|Intravenous Infusion of BI 836909 (13 μg/d)|Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796931|NCT02514239|OG004|Outcome|Intravenous Infusion of BI 836909 (25 μg/d)|Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796932|NCT02514239|OG005|Outcome|Intravenous Infusion of BI 836909 (50 μg/d)|Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796933|NCT02514239|OG006|Outcome|Intravenous Infusion of BI 836909 (100 μg/d)|Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796934|NCT02514239|OG007|Outcome|Intravenous Infusion of BI 836909 (200 μg/d)|Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796935|NCT02514239|OG008|Outcome|Intravenous Infusion of BI 836909 (400 μg/d)|Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796936|NCT02514239|OG009|Outcome|Intravenous Infusion of BI 836909 (800 μg/d)|Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
11196172|NCT02163447|OG000|Outcome|3 Dose SP Pregnancy / 3 Monthly DP Infancy|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.~3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy~3-monthly dihydroartemisinin-piperaquine (DP) for infants"
11202270|NCT02206685|OG001|Outcome|Control Group|"The control group will receive a 20 ml normal saline placebo infusion over 10 minutes~Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes"
11383742|NCT01374516|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383743|NCT01374516|FG001|Participant Flow|Placebo Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383744|NCT01374516|OG000|Outcome|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
11383745|NCT01374516|OG001|Outcome|Placebo Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.
11383746|NCT01374516|OG000|Outcome|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383747|NCT01374516|OG001|Outcome|Placebo Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383748|NCT01374516|OG001|Outcome|Control Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383749|NCT01374516|OG000|Outcome|CYD Dengue Vaccine Group|Subset of participants who received at least one dose of CYD Dengue vaccine.
11383750|NCT01374516|OG001|Outcome|Placebo Group|Subset of participants who received at least one dose of placebo vaccine.
11383751|NCT01374516|OG001|Outcome|Placebo Group|Subset of participants who received at least one dose of the placebo vaccine.
11383752|NCT01374516|OG001|Outcome|Control Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.
11383753|NCT01374516|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
11383754|NCT01374516|EG001|Reported Event|Placebo Group|Participants received 3 doses of placebo vaccine; one each at 0, 6, and 12 months.
11383755|NCT01373281|BG000|Baseline|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383756|NCT01373281|BG001|Baseline|Placebo Group|Participants received 3 doses of placebo vaccine, one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383757|NCT01373281|BG002|Baseline|Total|Total of all reporting groups
11383758|NCT01373281|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383759|NCT01373281|FG001|Participant Flow|Placebo Group|Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
11383760|NCT01373281|OG000|Outcome|CYD Dengue Vaccine Group|Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
11383761|NCT01373281|OG001|Outcome|Placebo Group|Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
11383762|NCT01373281|OG000|Outcome|CYD Dengue Vaccine Group|Subset of participants who received at least one dose of CYD Dengue vaccine.
11383763|NCT01373281|OG001|Outcome|Placebo Group|Subset of participants who received at least one dose of the placebo vaccine.
11383764|NCT01373281|OG000|Outcome|CYD Dengue Vaccine Group|Subset of participants who received at least one dose of CYD Dengue vaccine
11383765|NCT01373281|OG001|Outcome|Placebo Group|Subset of participants who received at least one dose of placebo vaccine
11383766|NCT01373281|OG001|Outcome|Placebo Group|Participant were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
11383767|NCT01373281|OG000|Outcome|CYD Dengue Vaccine Group|Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
11383768|NCT01373281|OG001|Outcome|Placebo Group|Participants were to receive 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
11383769|NCT01373281|EG000|Reported Event|CYD Dengue Vaccine Group|Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
11383770|NCT01373281|EG001|Reported Event|Placebo Group|Participants were to receive 3 doses of placebo vaccine; one each at 0, 6, and 12 months.
11383771|NCT01302847|BG000|Baseline|Cohort I|"Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383772|NCT01302847|BG001|Baseline|Cohort IIA|"Children 6 to younger than 12 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383773|NCT01302847|BG002|Baseline|Cohort IIB|"Children 6 to younger than 12 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383774|NCT01302847|BG003|Baseline|Cohort III|"Children 2 to younger than 6 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383775|NCT01302847|BG004|Baseline|Cohort IV|"Children 6 months to younger than 2 years of age who received DTG granules for suspension.~DDTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383776|NCT01302847|BG005|Baseline|Cohort III-DT|"Children 2 to younger than 6 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily."
11383777|NCT01302847|BG006|Baseline|Cohort IV-DT|"Children 6 months to younger than 2 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11196173|NCT02163447|OG001|Outcome|3 Dose DP Pregnancy / 3 Monthly DP Infancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.~3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~3-monthly dihydroartemisinin-piperaquine (DP) for infants"
10796937|NCT02514239|OG000|Outcome|Intravenous Infusion of BI 836909 (0.2 μg/d)|Intravenous infusion of BI 836909 (0.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796938|NCT02514239|OG001|Outcome|Intravenous Infusion of BI 836909 (0.4 μg/d)|Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796939|NCT02514239|OG002|Outcome|Intravenous Infusion of BI 836909 (0.8 μg/d)|Intravenous infusion of BI 836909 (0.8 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796940|NCT02514239|OG003|Outcome|Intravenous Infusion of BI 836909 (1.6 μg/d)|Intravenous infusion of BI 836909 (1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796941|NCT02514239|OG004|Outcome|Intravenous Infusion of BI 836909 (3.2 μg/d)|Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796942|NCT02514239|OG005|Outcome|Intravenous Infusion of BI 836909 (6.5 μg/d)|Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796943|NCT02514239|OG006|Outcome|Intravenous Infusion of BI 836909 (13 μg/d)|Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles
10796944|NCT02514239|OG007|Outcome|Intravenous Infusion of BI 836909 (25 μg/d)|Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796945|NCT02514239|OG008|Outcome|Intravenous Infusion of BI 836909 (50 μg/d)|Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796946|NCT02514239|OG009|Outcome|Intravenous Infusion of BI 836909 (100 μg/d)|Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796947|NCT02514239|OG010|Outcome|Intravenous Infusion of BI 836909 (200 μg/d)|Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796948|NCT02514239|OG011|Outcome|Intravenous Infusion of BI 836909 (400 μg/d)|Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796949|NCT02514239|OG012|Outcome|Intravenous Infusion of BI 836909 (800 μg/d)|Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796950|NCT02514239|EG000|Reported Event|Intravenous Infusion of BI 836909 (0.2 μg/d)|Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796951|NCT02514239|EG001|Reported Event|Intravenous Infusion of BI 836909 (0.4 μg/d)|Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796952|NCT02514239|EG002|Reported Event|Intravenous Infusion of BI 836909 (0.8 μg/d)|Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796953|NCT02514239|EG003|Reported Event|Intravenous Infusion of BI 836909 (1.6 μg/d)|Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796954|NCT02514239|EG004|Reported Event|Intravenous Infusion of BI 836909 (3.2 μg/d)|Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796955|NCT02514239|EG005|Reported Event|Intravenous Infusion of BI 836909 (6.5 μg/d)|Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796956|NCT02514239|EG006|Reported Event|Intravenous Infusion of BI 836909 (13 μg/d)|Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796957|NCT02514239|EG007|Reported Event|Intravenous Infusion of BI 836909 (25 μg/d)|Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796958|NCT02514239|EG008|Reported Event|Intravenous Infusion of BI 836909 (50 μg/d)|Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796959|NCT02514239|EG009|Reported Event|Intravenous Infusion of BI 836909 (100 μg/d)|Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796960|NCT02514239|EG010|Reported Event|Intravenous Infusion of BI 836909 (200 μg/d)|Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796961|NCT02514239|EG011|Reported Event|Intravenous Infusion of BI 836909 (400 μg/d)|Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
10796962|NCT02514239|EG012|Reported Event|Intravenous Infusion of BI 836909 (800 μg/d)|Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
11383778|NCT01302847|BG007|Baseline|Cohort V-DT|"Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383779|NCT01302847|BG008|Baseline|Total|Total of all reporting groups
11383780|NCT01302847|FG000|Participant Flow|Cohort I|"Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383781|NCT01302847|FG001|Participant Flow|Cohort IIA|"Children 6 to younger than 12 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383782|NCT01302847|FG002|Participant Flow|Cohort III|"Children 2 to younger than 6 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383783|NCT01302847|FG003|Participant Flow|Cohort IIB|"Children 6 to younger than 12 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383784|NCT01302847|FG004|Participant Flow|Cohort IV|"Children 6 months to younger than 2 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383785|NCT01302847|FG005|Participant Flow|Cohort III-DT|"Children 2 to younger than 6 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily."
11383786|NCT01302847|FG006|Participant Flow|Cohort IV-DT|"Children 6 months to younger than 2 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383787|NCT01302847|FG007|Participant Flow|Cohort V-DT|"Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383788|NCT01302847|OG000|Outcome|Cohort I|"Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383789|NCT01302847|OG001|Outcome|Cohort IIA|"Children 6 to younger than 12 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383790|NCT01302847|OG002|Outcome|Cohort IIB|"Children 6 to younger than 12 years of age who received DTG granules for suspension~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383791|NCT01302847|OG003|Outcome|Cohort III|"Children 2 to younger than 6 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383792|NCT01302847|OG004|Outcome|Cohort IV|"Children 6 months to younger than 2 years of age who received DTG granules for suspension~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383793|NCT01302847|OG005|Outcome|Cohort III-DT|"Children 2 to younger than 6 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily."
11383794|NCT01302847|OG006|Outcome|Cohort IV-DT|"Children 6 months to younger than 2 years of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383795|NCT01302847|OG007|Outcome|Cohort V-DT|"Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383796|NCT01302847|OG002|Outcome|Cohort IIB|"Children 6 to younger than 12 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383797|NCT01302847|OG003|Outcome|Cohort III|"Children 2 to younger than 6 years of age who received DTG granules for suspension~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383798|NCT01302847|OG004|Outcome|Cohort IV|"Children 6 months to younger than 2 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383799|NCT01302847|OG000|Outcome|Cohort I|Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
11383800|NCT01302847|OG001|Outcome|Cohort IIA|Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
11383801|NCT01302847|OG002|Outcome|Cohort III-DT|Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
11383802|NCT01302847|OG003|Outcome|Cohort IV-DT|Children 6 months to younger than 2 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
11383803|NCT01302847|OG004|Outcome|Cohort V-DT|Infants 4 weeks to younger than 6 months of age who received weight band doing at ~1 mg/kg of DTG dispersible tablet orally once daily.
11383804|NCT01302847|OG007|Outcome|Cohort V-DT|"Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.~DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily."
11383805|NCT01302847|EG000|Reported Event|Cohort I|"Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383806|NCT01302847|EG001|Reported Event|Cohort IIA|"Children 6 to younger than 12 years of age who received DTG film-coated tablets.~DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily."
11383807|NCT01302847|EG002|Reported Event|Cohort IIB|"Children 6 to younger than 12 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
10796963|NCT02514239|EG013|Reported Event|Intravenous Infusion of BI 836909 (Total Dose Escalation)|BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
10796964|NCT02512510|BG000|Baseline|TD-4208-1|"88 mcg~TD-4208"
10796965|NCT02512510|BG001|Baseline|TD-4208-2|"175 mcg~TD-4208"
10796966|NCT02512510|BG002|Baseline|Placebo|"Placebo~Placebo"
10796967|NCT02512510|BG003|Baseline|Total|Total of all reporting groups
10796968|NCT02512510|FG000|Participant Flow|TD-4208-1|"88 mcg~TD-4208"
10796969|NCT02512510|FG001|Participant Flow|TD-4208-2|"175 mcg~TD-4208"
10796970|NCT02512510|FG002|Participant Flow|Placebo|"Placebo~Placebo"
10796971|NCT02512510|OG000|Outcome|TD-4208-1|"88 mcg~TD-4208"
10796972|NCT02512510|OG001|Outcome|TD-4208-2|"175 mcg~TD-4208"
10796973|NCT02512510|OG002|Outcome|Placebo|"Placebo~Placebo"
10796974|NCT02512510|EG000|Reported Event|TD-4208-1|"88 mcg~TD-4208"
10796975|NCT02512510|EG001|Reported Event|TD-4208-2|"175 mcg~TD-4208"
10796976|NCT02512510|EG002|Reported Event|Placebo|"Placebo~Placebo"
10796977|NCT02459080|BG000|Baseline|TD-4208-1|"88 mcg~TD-4208"
10796978|NCT02459080|BG001|Baseline|TD-4208-2|"175 mcg~TD-4208"
10796979|NCT02459080|BG002|Baseline|Placebo|"Placebo~Placebo"
10796980|NCT02459080|BG003|Baseline|Total|Total of all reporting groups
10796981|NCT02459080|FG000|Participant Flow|TD-4208-1|"88 mcg~TD-4208"
10796982|NCT02459080|FG001|Participant Flow|TD-4208-2|"175 mcg~TD-4208"
10796983|NCT02459080|FG002|Participant Flow|Placebo|"Placebo~Placebo"
10796984|NCT02459080|OG000|Outcome|TD-4208-1|"88 mcg~TD-4208"
10796985|NCT02459080|OG001|Outcome|TD-4208-2|"175 mcg~TD-4208"
10796986|NCT02459080|OG002|Outcome|Placebo|"Placebo~Placebo"
10796987|NCT02459080|EG000|Reported Event|TD-4208-1|"88 mcg~TD-4208"
10796988|NCT02459080|EG001|Reported Event|TD-4208-2|"175 mcg~TD-4208"
10796989|NCT02459080|EG002|Reported Event|Placebo|"Placebo~Placebo"
10796990|NCT02245672|BG000|Baseline|MGR001|"MGR001 administered two times per day by inhalation throughout the study~MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device"
10796991|NCT02245672|BG001|Baseline|Advair Diskus|"Advair Diskus administered two times per day by inhalation throughout the study~Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device"
10796992|NCT02245672|BG002|Baseline|Placebo|"Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study~Placebo: Placebo administered via the CRC749 and Diskus devices"
10796993|NCT02245672|BG003|Baseline|Total|Total of all reporting groups
10796994|NCT02245672|FG000|Participant Flow|MGR001|"MGR001 administered two times per day by inhalation throughout the study~MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device"
10796995|NCT02245672|FG001|Participant Flow|Advair Diskus|"Advair Diskus administered two times per day by inhalation throughout the study~Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device"
10796996|NCT02245672|FG002|Participant Flow|Placebo|"Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study~Placebo: Placebo administered via the CRC749 and Diskus devices"
10796997|NCT02245672|OG000|Outcome|MGR001|"MGR001 administered two times per day by inhalation throughout the study~MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device"
10796998|NCT02245672|OG001|Outcome|Advair Diskus|"Advair Diskus administered two times per day by inhalation throughout the study~Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device"
10796999|NCT02245672|OG002|Outcome|Placebo|"Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study~Placebo: Placebo administered via the CRC749 and Diskus devices"
10797000|NCT02245672|EG000|Reported Event|MGR001|"MGR001 administered two times per day by inhalation throughout the study~MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device"
10797001|NCT02245672|EG001|Reported Event|Advair Diskus|"Advair Diskus administered two times per day by inhalation throughout the study~Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device"
10797002|NCT02245672|EG002|Reported Event|Placebo|"Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study~Placebo: Placebo administered via the CRC749 and Diskus devices"
10797003|NCT02109172|BG000|Baseline|Entire Study Population|All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
10797004|NCT02109172|FG000|Participant Flow|Placebo First, Then 44mcg, Then 175mcg|Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
10797005|NCT02109172|FG001|Participant Flow|Placebo First, Then 175mcg, Then 44mcg|Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
10797006|NCT02109172|FG002|Participant Flow|44mcg First, Then 175mcg, Then Placebo|44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
10797007|NCT02109172|FG003|Participant Flow|44mcg First, Then Placebo, Then 175mcg|44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
10797008|NCT02109172|FG004|Participant Flow|175mcg First, Then 44mcg, Then Placebo|175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
10797009|NCT02109172|FG005|Participant Flow|175mcg First, Then Placebo, Then 44mcg|175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
10797010|NCT02109172|OG000|Outcome|Placebo|"Placebo inhalation solution twice daily for 7 days~Placebo"
10797011|NCT02109172|OG001|Outcome|TD-4208 44 mcg Twice Daily|"TD-4208 inhalation solution 44 mcg twice daily for 7 days~TD-4208"
10797012|NCT02109172|OG002|Outcome|TD-4208 175 mcg Once Daily|"TD-4208 inhalation solution 175 mcg once daily, placebo once daily~TD-4208~Placebo"
10797013|NCT02109172|EG000|Reported Event|Placebo|Placebo inhalation solution twice daily for 7 days
10797014|NCT02109172|EG001|Reported Event|TD-4208 44mcg Twice Daily|TD-4208 inhalation solution 44 mcg twice daily for 7 days
10797015|NCT02109172|EG002|Reported Event|TD-4208 175mcg Once Daily|TD-4208 inhalation solution 175 mcg once daily
10797016|NCT02040792|BG000|Baseline|Placebo|"Placebo~Placebo"
10797017|NCT02040792|BG001|Baseline|44 mcg|"TD-4208~TD-4208"
10797018|NCT02040792|BG002|Baseline|88 mcg|"TD-4208~TD-4208"
10797019|NCT02040792|BG003|Baseline|175 mcg|"TD-4208~TD-4208"
10797020|NCT02040792|BG004|Baseline|350 mcg|"TD-4208~TD-4208"
10797021|NCT02040792|BG005|Baseline|Total|Total of all reporting groups
10797022|NCT02040792|FG000|Participant Flow|Placebo|"Placebo~Placebo"
10797023|NCT02040792|FG001|Participant Flow|44 mcg|"TD-4208~TD-4208"
10797024|NCT02040792|FG002|Participant Flow|88 mcg|"TD-4208~TD-4208"
10797025|NCT02040792|FG003|Participant Flow|175 mcg|"TD-4208~TD-4208"
10797026|NCT02040792|FG004|Participant Flow|350 mcg|"TD-4208~TD-4208"
10797027|NCT02040792|OG000|Outcome|Placebo|"Placebo~Placebo"
10797028|NCT02040792|OG001|Outcome|44 mcg|"TD-4208~TD-4208"
10797029|NCT02040792|OG002|Outcome|88 mcg|"TD-4208~TD-4208"
10797030|NCT02040792|OG003|Outcome|175 mcg|"TD-4208~TD-4208"
10797031|NCT02040792|OG004|Outcome|350 mcg|"TD-4208~TD-4208"
10797032|NCT02040792|EG000|Reported Event|Placebo|"Placebo~Placebo"
10797033|NCT02040792|EG001|Reported Event|44 mcg|"TD-4208~TD-4208"
10797034|NCT02040792|EG002|Reported Event|88 mcg|"TD-4208~TD-4208"
10797035|NCT02040792|EG003|Reported Event|175 mcg|"TD-4208~TD-4208"
10797036|NCT02040792|EG004|Reported Event|350 mcg|"TD-4208~TD-4208"
10797037|NCT01979003|BG000|Baseline|Fluorescein Injection|"All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.~Fluorescein"
10797038|NCT01979003|FG000|Participant Flow|Fluorescein Injection|"All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.~Fluorescein"
10797039|NCT01979003|OG000|Outcome|Fluorescein Injection|"All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.~Fluorescein"
10797040|NCT01979003|EG000|Reported Event|Fluorescein Injection|"All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.~Fluorescein"
10797041|NCT01704404|BG000|Baseline|Entire Study Population|"All subjects received Placebo and 4 of 6 TD-4208 dose levels:~TD-4208 - 22 µg TD-4208 - 44 µg TD-4208 - 88 µg TD-4208 - 175 µg TD-4208 - 350 µg TD-4208 - 700 µg"
10797042|NCT01704404|FG000|Participant Flow|Treatment 1|Placebo, 44 µg, 88 µg, 350 µg, 700 µg
10797043|NCT01704404|FG001|Participant Flow|Treatment 2|Placebo, 22 µg, 88 µg, 350 µg, 700 µg
10797044|NCT01704404|FG002|Participant Flow|Treatment 3|Placebo, 22 µg, 88 µg, 175 µg, 700 µg
10797045|NCT01704404|FG003|Participant Flow|Treatment 4|22 µg, 44 µg, 175 µg, 700 µg
10797046|NCT01704404|FG004|Participant Flow|Treatment 5|22 µg, 44 µg, 175 µg, 350 µg
10797047|NCT01704404|FG005|Participant Flow|Treatment 6|Placebo, 44 µg, 88 µg, 175 µg, 350 µg
10797048|NCT01704404|OG000|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
10797049|NCT01704404|OG001|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
10797050|NCT01704404|OG002|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
10797051|NCT01704404|OG003|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
10797052|NCT01704404|OG004|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
10797053|NCT01704404|OG005|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
10797054|NCT01704404|OG006|Outcome|Placebo|"Placebo~Placebo"
10797055|NCT01704404|EG000|Reported Event|Dose 1 TD-4208|"22 µg~TD-4208"
10797056|NCT01704404|EG001|Reported Event|Dose 2 TD-4208|"44 µg~TD-4208"
10797057|NCT01704404|EG002|Reported Event|Dose 3 TD-4208|"88 µg~TD-4208"
10797058|NCT01704404|EG003|Reported Event|Dose 4 TD-4208|"175 µg~TD-4208"
10797059|NCT01704404|EG004|Reported Event|Dose 5 TD-4208|"350 µg~TD-4208"
10797060|NCT01704404|EG005|Reported Event|Dose 6 TD-4208|"700 µg~TD-4208"
10797061|NCT01704404|EG006|Reported Event|Placebo|"Placebo~Placebo"
10797062|NCT01307813|BG000|Baseline|Endoscopic Suturing Device|"Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model"
10803279|NCT01597388|OG004|Outcome|125 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10797063|NCT01307813|FG000|Participant Flow|Endoscopic Suturing Device|"Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model"
10797064|NCT01307813|OG000|Outcome|Endoscopic Suturing Device|"Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model."
10797065|NCT01307813|EG000|Reported Event|Endoscopic Suturing Device|"Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.~Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model"
10797066|NCT00799396|BG000|Baseline|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
10797067|NCT00799396|FG000|Participant Flow|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
10797068|NCT00799396|OG000|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
10797069|NCT00799396|EG000|Reported Event|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
10797070|NCT00069238|BG000|Baseline|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
10797071|NCT00069238|FG000|Participant Flow|Alemtuzumab 30 mg|Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
10797072|NCT00069238|FG001|Participant Flow|Alemtuzumab 60 mg|Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
10797073|NCT00069238|FG002|Participant Flow|Alemtuzumab 90 mg|Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
10797074|NCT00069238|OG000|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
10797075|NCT00069238|OG000|Outcome|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
10797076|NCT00069238|EG000|Reported Event|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
10803280|NCT01597388|OG005|Outcome|125 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803281|NCT01597388|OG006|Outcome|170 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10797077|NCT03138499|BG000|Baseline|Nivolumab + Brentuximab Vedotin (BV)|Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
10797078|NCT03138499|BG001|Baseline|Brentuximab Vedotin (BV)|BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
10797079|NCT03138499|BG002|Baseline|Total|Total of all reporting groups
10797080|NCT03138499|FG000|Participant Flow|Nivolumab + Brentuximab Vedotin (BV)|Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
10797081|NCT03138499|FG001|Participant Flow|Brentuximab Vedotin (BV)|BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
10797082|NCT03138499|OG000|Outcome|Nivolumab + Brentuximab Vedotin (BV)|Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
10797083|NCT03138499|OG001|Outcome|Brentuximab Vedotin (BV)|BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
10797084|NCT03138499|OG001|Outcome|Brentuximab Vedotin (BV)|BV alone 1.8 mg/kg every 3 weeks for 16 cycles, or until progression or unacceptable toxicity, whichever occurs first
10797085|NCT03138499|EG000|Reported Event|Nivolumab + Brentuximab Vedotin (BV)|Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
10797086|NCT03138499|EG001|Reported Event|Brentuximab Vedotin (BV)|BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
10797087|NCT03107208|BG000|Baseline|Early Glargine (Lantus)|"A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10797088|NCT03107208|BG001|Baseline|Control Group|"A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10797089|NCT03107208|BG002|Baseline|Total|Total of all reporting groups
10797090|NCT03107208|FG000|Participant Flow|Early Glargine (Lantus)|"A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10797091|NCT03107208|FG001|Participant Flow|Control Group|"A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
11202271|NCT02206685|EG000|Reported Event|Treatment Group|"The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.~Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes"
11202272|NCT02206685|EG001|Reported Event|Control Group|"The control group will receive a 20 ml normal saline placebo infusion over 10 minutes~Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes"
11202273|NCT02206776|BG000|Baseline|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
10797092|NCT03107208|OG000|Outcome|Early Glargine (Lantus)|"A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10803282|NCT01597388|OG007|Outcome|170 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11383808|NCT01302847|EG003|Reported Event|Cohort III|"Children 2 to younger than 6 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383809|NCT01302847|EG004|Reported Event|Cohort IV|"Children 6 months to younger than 2 years of age who received DTG granules for suspension.~DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily."
11383810|NCT01302847|EG005|Reported Event|Cohort III-DT|Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tables initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
11383811|NCT01302847|EG006|Reported Event|Cohort IV-DT|"Children 6 months to younger than 2 years of age who received DTG dispersible tablets.~DTG dispersible tables initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383812|NCT01302847|EG007|Reported Event|Cohort V-DT|"Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.~DTG dispersible tables initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily."
11383813|NCT01287611|BG000|Baseline|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
11383814|NCT01287611|BG001|Baseline|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
11383815|NCT01287611|BG002|Baseline|Total|Total of all reporting groups
11383816|NCT01287611|FG000|Participant Flow|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
11383817|NCT01287611|FG001|Participant Flow|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
11383818|NCT01287611|OG000|Outcome|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
11383819|NCT01287611|OG001|Outcome|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
11383820|NCT01287611|OG000|Outcome|Purse String Closure Technique|"Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.~Purse string closure technique: Uterine Kerr incision will be closed with purse string suture"
11383821|NCT01287611|OG001|Outcome|Continuously Locked Closure Technique|"Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.~Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing"
11383822|NCT01287611|EG000|Reported Event|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
11383823|NCT01287611|EG001|Reported Event|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
11383824|NCT01254422|BG000|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383825|NCT01254422|BG001|Baseline|Placebo Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383826|NCT01254422|BG002|Baseline|Total|Total of all reporting groups
11383827|NCT01254422|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections (Inj.) of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383828|NCT01254422|FG001|Participant Flow|Placebo Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383829|NCT01254422|OG000|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383830|NCT01254422|OG001|Outcome|Placebo Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383831|NCT01254422|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383832|NCT01254422|EG001|Reported Event|Placebo Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383833|NCT01187433|BG000|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383834|NCT01187433|BG001|Baseline|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383835|NCT01187433|BG002|Baseline|Total|Total of all reporting groups
11383836|NCT01187433|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383837|NCT01187433|FG001|Participant Flow|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383838|NCT01187433|OG000|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383839|NCT01187433|OG001|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383840|NCT01187433|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
11383841|NCT01187433|EG001|Reported Event|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
11383842|NCT01150045|BG000|Baseline|Arm A - FOLFOX and Placebo (12 Treatments)|The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383843|NCT01150045|BG001|Baseline|Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily|The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383844|NCT01150045|BG002|Baseline|Arm C - 6 Cycles of FOLFOX Plus Placebo Daily|The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383845|NCT01150045|BG003|Baseline|Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily|The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383846|NCT01150045|BG004|Baseline|Total|Total of all reporting groups
11383847|NCT01150045|FG000|Participant Flow|Arm A - 12 Cycles of FOLFOX Plus Placebo Daily|"The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383848|NCT01150045|FG001|Participant Flow|Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily|"The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383849|NCT01150045|FG002|Participant Flow|Arm C - 6 Cycles of FOLFOX Plus Placebo Daily|"The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383850|NCT01150045|FG003|Participant Flow|Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily|"The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383851|NCT01150045|OG000|Outcome|FOLFOX and Placebo (Arms A +C)|"Arm A~The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.~Arm C~The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383852|NCT01150045|OG001|Outcome|FOLFOX Plus Celecoxib Daily (Arms B + D)|"Arm B~The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.~Arm D~The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.~Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity."
11383853|NCT01150045|EG000|Reported Event|Arm A - FOLFOX and Placebo (12 Treatments)|Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383854|NCT01150045|EG001|Reported Event|Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily|Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383855|NCT01150045|EG002|Reported Event|Arm C - 6 Cycles of FOLFOX Plus Placebo Daily|Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383856|NCT01150045|EG003|Reported Event|Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily|Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
11383857|NCT01098032|BG000|Baseline|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
11383858|NCT01098032|BG001|Baseline|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
11383859|NCT01098032|BG002|Baseline|Total|Total of all reporting groups
11383860|NCT01098032|FG000|Participant Flow|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
11383861|NCT01098032|FG001|Participant Flow|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
11383862|NCT01098032|OG000|Outcome|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
11383863|NCT01098032|OG001|Outcome|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
11383864|NCT01098032|EG000|Reported Event|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure.
11383865|NCT01098032|EG001|Reported Event|Systemic Alone Therapy Group|Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration.
11383866|NCT01034306|BG000|Baseline|CF101 1mg|CF101 1mg q12 for 12 weeks
11383867|NCT01034306|BG001|Baseline|Placebo|MAtching placebo q12 for 12 weeks
11383868|NCT01034306|BG002|Baseline|Total|Total of all reporting groups
11383869|NCT01034306|FG000|Participant Flow|CF101 1mg|CF101 1mg q12 for 12 weeks
11383870|NCT01034306|FG001|Participant Flow|Placebo|Matching placebo q12 for 12 weeks
11383871|NCT01034306|OG000|Outcome|CF101 1mg|CF101 1mg q12 for 12 weeks
11383872|NCT01034306|OG001|Outcome|Placebo|Matching placebo q12 for 12 weeks
11383873|NCT01034306|EG000|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
11383874|NCT01034306|EG001|Reported Event|Placebo|Matching placebo q12 for 12 weeks
11383875|NCT01005745|BG000|Baseline|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
11383876|NCT01005745|FG000|Participant Flow|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
11383877|NCT01005745|OG000|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
11383878|NCT01005745|EG000|Reported Event|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
11383879|NCT00993447|BG000|Baseline|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
11383880|NCT00993447|BG001|Baseline|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
11383881|NCT00993447|BG002|Baseline|Total|Total of all reporting groups
10797093|NCT03107208|OG001|Outcome|Control Group|"A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
11383882|NCT00993447|FG000|Participant Flow|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
11383883|NCT00993447|FG001|Participant Flow|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
11383884|NCT00993447|OG000|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
11383885|NCT00993447|OG001|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
11202274|NCT02206776|BG001|Baseline|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
11383886|NCT00993447|EG000|Reported Event|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
11383887|NCT00993447|EG001|Reported Event|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
11383888|NCT00945009|BG000|Baseline|Arm 1 (Bilateral Wilms Tumors)|"Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11196174|NCT02163447|OG002|Outcome|3 Dose DP Pregnancy / Monthly DP Infancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age.~3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
10797094|NCT03107208|EG000|Reported Event|Early Glargine (Lantus)|"A dose of glargine (Lantus®) is given subcutaneously early in the management of DKA (i.e. while the participant is still receiving intravenous insulin). Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10797095|NCT03107208|EG001|Reported Event|Control Group|"A dose of glargine (Lantus®) is given subcutaneously after resolution of the DKA (i.e. when the intravenous insulin is stopped). This is currently the standard-of-care practice for children in DKA. Participants will also be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA.~Glargine: A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).~Continuous Glucose Monitor (Abbott FreeStyle Libre Pro): All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study."
10803283|NCT01597388|OG008|Outcome|125 mg BID Intermittent Days 1 and 4 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803284|NCT01597388|OG000|Outcome|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
10803285|NCT01597388|OG001|Outcome|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
10803286|NCT01597388|OG002|Outcome|75 mg QD Continuous|Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
10803287|NCT01597388|OG003|Outcome|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
10803288|NCT01597388|OG000|Outcome|125 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803289|NCT01597388|OG001|Outcome|125 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803290|NCT01597388|OG002|Outcome|170 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803291|NCT01597388|OG003|Outcome|170 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803292|NCT01597388|OG002|Outcome|75 mg QD Continuous|Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803293|NCT01597388|OG003|Outcome|100 mg QD Continuously|Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803294|NCT01597388|OG000|Outcome|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803295|NCT01597388|OG001|Outcome|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803296|NCT01597388|OG000|Outcome|35 mg|Participants received a single dose of 35 mg of AZD2014 in fasted condition.
10803297|NCT01597388|OG001|Outcome|50 mg|Participants received a single dose of 50 mg of AZD2014 in fasted condition.
10803298|NCT01597388|OG002|Outcome|75 mg|Participants received a single dose of 75 mg of AZD2014 in fasted condition.
10803299|NCT01597388|OG003|Outcome|100 mg|Participants received a single dose of 100 mg of AZD2014 in fasted condition.
11202275|NCT02206776|BG002|Baseline|Total|Total of all reporting groups
11202276|NCT02206776|FG000|Participant Flow|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
10803300|NCT01597388|OG003|Outcome|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803301|NCT01597388|EG000|Reported Event|35 mg BID Continuous|Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
11202277|NCT02206776|FG001|Participant Flow|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
11383889|NCT00945009|BG001|Baseline|Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)|"Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383890|NCT00945009|BG002|Baseline|Arm 3 (DHPLN)|"Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383891|NCT00945009|BG003|Baseline|Total|Total of all reporting groups
11383892|NCT00945009|FG000|Participant Flow|Arm 1 (Bilateral Wilms Tumors)|"Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383893|NCT00945009|FG001|Participant Flow|Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)|"Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383894|NCT00945009|FG002|Participant Flow|Arm 3 (DHPLN)|"Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383895|NCT00945009|OG000|Outcome|Arm 1 (Bilateral Wilms Tumors)|"Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383896|NCT00945009|OG000|Outcome|Arm 3 (DHPLN)|Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.
11383897|NCT00945009|OG000|Outcome|Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)|"Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383898|NCT00945009|EG000|Reported Event|Arm 1 (Bilateral Wilms Tumors)|"Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383899|NCT00945009|EG001|Reported Event|Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)|"Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383900|NCT00945009|EG002|Reported Event|Arm 3 (DHPLN)|"Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Radiation Therapy: Undergo radiation therapy~Therapeutic Conventional Surgery: Undergo surgical resection~Vincristine Sulfate: Given IV"
11383901|NCT00942877|BG000|Baseline|Adult Participants w/Alveolar Soft Part Sarcoma|"Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
10797100|NCT04391959|BG000|Baseline|AZR-MD-001 Vehicle|"AZR-MD-001 Vehicle will be dosed up to twice weekly.~AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment"
11196175|NCT02163447|OG003|Outcome|Monthly DP Pregnancy / 3 Monthly DP Infancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~3-monthly dihydroartemisinin-piperaquine (DP) for infants"
11383902|NCT00942877|BG001|Baseline|Pediatric Participants w/Alveolar Soft Part Sarcoma|"Pediatric participants will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383903|NCT00942877|BG002|Baseline|Total|Total of all reporting groups
11383904|NCT00942877|FG000|Participant Flow|Adult Participants w/Alveolar Soft Part Sarcoma|"Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383905|NCT00942877|FG001|Participant Flow|Pediatric Participants w/Alveolar Soft Part Sarcoma|"Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383906|NCT00942877|OG000|Outcome|Pediatric Participants w/Alveolar Soft Part Sarcoma|"Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383907|NCT00942877|OG000|Outcome|Adult Participants w/Alveolar Soft Part Sarcoma|"Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383908|NCT00942877|OG001|Outcome|Pediatric Participants w/Alveolar Soft Part Sarcoma|"Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383909|NCT00942877|EG000|Reported Event|Adult Participants w/Alveolar Soft Part Sarcoma|"Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383910|NCT00942877|EG001|Reported Event|Pediatric Participants w/Alveolar Soft Part Sarcoma|"Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles).~AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS)."
11383911|NCT00896389|BG000|Baseline|Salt-loading and Thiazide Diuretic (HCTZ)|"Salt loading: Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 L of 0.9% NaCl (sodium chloride) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.~Hydrochlorothiazide (HCTZ): After overnight fasting and having their height, weight, and BP measured, subjects are given 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure, blood and urine will be collected on both day 1 and day 8. After a wash-out period, the subjects will repeat the HCTZ intervention, taking 25 mg HCTZ instead."
11383912|NCT00896389|FG000|Participant Flow|Salt-loading and Thiazide Diuretics (HCTZ)|Salt loading: 2 liters (L) of 0.9% sodium chloride (NaCl). HCTZ:12.5 or 25 mg of HCTZ for 1 week
11383913|NCT00896389|OG000|Outcome|rs35929607 SNP|"Single nucleotide polymorphism (SNP) rs35929607, located in an intron of serine threonine kinase 39 (STK39) gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
11383914|NCT00896389|OG000|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
11383915|NCT00896389|EG000|Reported Event|Salt Loading|Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 L of 0.9% NaCl (sodium chloride) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.
10797096|NCT04509739|BG000|Baseline|Music Intervention|"Music intervention: At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.~The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study."
10797097|NCT04509739|FG000|Participant Flow|Music Intervention|"Music intervention: At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.~The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study."
10797098|NCT04509739|OG000|Outcome|Music Intervention|"Music intervention: At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.~The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study."
10797099|NCT04509739|EG000|Reported Event|Music Intervention|"Music intervention: At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.~The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study."
10797101|NCT04391959|BG001|Baseline|AZR-MD-001 Active|"AZR-MD-001 Active will be dosed up to twice weekly.~AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment"
10797102|NCT04391959|BG002|Baseline|Total|Total of all reporting groups
10797103|NCT04391959|FG000|Participant Flow|AZR-MD-001 Vehicle|"AZR-MD-001 Vehicle will be dosed up to twice weekly.~AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment"
10797104|NCT04391959|FG001|Participant Flow|AZR-MD-001 Active|"AZR-MD-001 Active will be dosed up to twice weekly.~AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment"
10797105|NCT04391959|OG000|Outcome|AZR-MD-001 Vehicle|"AZR-MD-001 Vehicle will be dosed up to twice weekly.~AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment"
10797106|NCT04391959|OG001|Outcome|AZR-MD-001 Active|"AZR-MD-001 Active will be dosed up to twice weekly.~AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment"
10797107|NCT04391959|EG000|Reported Event|AZR-MD-001 Vehicle|"AZR-MD-001 Vehicle will be dosed up to twice weekly.~AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment"
10797108|NCT04391959|EG001|Reported Event|AZR-MD-001 Active|"AZR-MD-001 Active will be dosed up to twice weekly.~AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment"
10797109|NCT04368364|BG000|Baseline|Group 1 (Control Group)|Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
10797110|NCT04368364|BG001|Baseline|Group 2(Bupivacaine Hydrochloride Group)|Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
10797111|NCT04368364|BG002|Baseline|Group 3 (Ropivacaine Hydrochloride Group)|ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
10797112|NCT04368364|BG003|Baseline|Total|Total of all reporting groups
10797113|NCT04368364|FG000|Participant Flow|Group 1 (Control Group)|Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
10797114|NCT04368364|FG001|Participant Flow|Group 2(Bupivacaine Hydrochloride Group)|Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
10797115|NCT04368364|FG002|Participant Flow|Group 3 (Ropivacaine Hydrochloride Group)|ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
10797116|NCT04368364|OG000|Outcome|Group 1 (Control Group)|Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
10797117|NCT04368364|OG001|Outcome|Group 2(Bupivacaine Hydrochloride Group)|Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
10797118|NCT04368364|OG002|Outcome|Group 3 (Ropivacaine Hydrochloride Group)|ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
10797119|NCT04368364|EG000|Reported Event|Group 1 (Control Group)|Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
10797120|NCT04368364|EG001|Reported Event|Group 2(Bupivacaine Hydrochloride Group)|Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
10797121|NCT04368364|EG002|Reported Event|Group 3 (Ropivacaine Hydrochloride Group)|ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
10797122|NCT04244084|BG000|Baseline|MMH-407|"Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.~Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.~MMH-407: Oral administration."
10797123|NCT04244084|BG001|Baseline|Placebo|"According to the scheme of receiving MMN-407 until the end of the study.~Placebo: Oral administration."
10797124|NCT04244084|BG002|Baseline|Total|Total of all reporting groups
10797125|NCT04244084|FG000|Participant Flow|MMH-407|"Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.~Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.~MMH-407: Oral administration."
10797126|NCT04244084|FG001|Participant Flow|Placebo|"According to the scheme of receiving MMN-407 until the end of the study.~Placebo: Oral administration."
10797127|NCT04244084|OG000|Outcome|MMH-407|"Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.~Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.~MMH-407: Oral administration."
10797128|NCT04244084|OG001|Outcome|Placebo|"According to the scheme of receiving MMN-407 until the end of the study.~Placebo: Oral administration."
10797129|NCT04244084|EG000|Reported Event|MMH-407|"Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.~Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.~MMH-407: Oral administration."
10797130|NCT04244084|EG001|Reported Event|Placebo|"According to the scheme of receiving MMN-407 until the end of the study.~Placebo: Oral administration."
10803302|NCT01597388|EG001|Reported Event|50 mg BID Continuous|Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803303|NCT01597388|EG002|Reported Event|75 mg QD Continuous|Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803304|NCT01597388|EG003|Reported Event|100 mg QD Continuous|Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
10803305|NCT01597388|EG004|Reported Event|125 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803306|NCT01597388|EG005|Reported Event|125 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803307|NCT01597388|EG006|Reported Event|170 mg BID Intermittent Days 1 and 2 (Fasted)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803308|NCT01597388|EG007|Reported Event|170 mg BID Intermittent Days 1 and 2 (Fed)|Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803309|NCT01597388|EG008|Reported Event|125 mg BID Intermittent Days 1 and 4 (Fasted)|Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
10803310|NCT01517802|BG000|Baseline|Abiraterone Acetate + Prednisone/Prednisolone|Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 [NCT00473512], COU-AA-002 [NCT00473746], COU-AA-006 [NCT00910754], COU-AA-206 [NCT01400555], COU-AA-301 [NCT00638690], COU-AA-302 [NCT00887198], COU-AA-BMA [NCT00544440]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
11202278|NCT02206776|OG000|Outcome|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
10797131|NCT04189588|BG000|Baseline|Cohort A|"Cetirizine HCl 10 mg/mL: a single 1 mL injection.~Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797132|NCT04189588|BG001|Baseline|Cohort B|"Diphenhydramine 50 mg/mL: a single 1 mL injection.~Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797133|NCT04189588|BG002|Baseline|Total|Total of all reporting groups
10797134|NCT04189588|FG000|Participant Flow|Cohort A|"Cetirizine HCl 10 mg/mL: a single 1 mL injection.~Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797135|NCT04189588|FG001|Participant Flow|Cohort B|"Diphenhydramine 50 mg/mL: a single 1 mL injection.~Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797136|NCT04189588|OG000|Outcome|Cohort A|"Cetirizine HCl 10 mg/mL: a single 1 mL injection.~Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797137|NCT04189588|OG001|Outcome|Cohort B|"Diphenhydramine 50 mg/mL: a single 1 mL injection.~Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797138|NCT04189588|EG000|Reported Event|Cohort A|"Cetirizine HCl 10 mg/mL: a single 1 mL injection.~Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797139|NCT04189588|EG001|Reported Event|Cohort B|"Diphenhydramine 50 mg/mL: a single 1 mL injection.~Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe~anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment."
10797140|NCT04150562|BG000|Baseline|Arm 1- Safety Run-in Dose Level 1|Interleukin 15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 4 cycles) with avelumab by intravenous (IV) infusion at a dose of 800mg on Day 8 and 22 of each cycle
10797141|NCT04150562|FG000|Participant Flow|Arm 1- Safety Run-in Dose Level 1|Interleukin 15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 4 cycles) with avelumab by intravenous (IV) infusion at a dose of 800mg on Day 8 and 22 of each cycle
10797142|NCT04150562|FG001|Participant Flow|Arm 2-Dose Expansion|Interleukin 15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28- day cycle (max 4 cycles) with avelumab by intravenous (IV) infusion at a dose of 800mg on Day 8 and 22 of each cycle to determine efficacy of treatment.
11202279|NCT02206776|OG001|Outcome|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
10797143|NCT04150562|OG000|Outcome|Arm 1- Safety Run-in Dose Level 1|Interleukin 15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 4 cycles) with avelumab by intravenous (IV) infusion at a dose of 800mg on Day 8 and 22 of each cycle
10797144|NCT04150562|EG000|Reported Event|Arm 1- Safety Run-in Dose Level 1|Interleukin 15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 4 cycles) with avelumab by intravenous (IV) infusion at a dose of 800mg on Day 8 and 22 of each cycle
10797145|NCT04115748|BG000|Baseline|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797146|NCT04115748|BG001|Baseline|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
10797147|NCT04115748|BG002|Baseline|Adalimumab 40 mg (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
10797148|NCT04115748|BG003|Baseline|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797149|NCT04115748|BG004|Baseline|Total|Total of all reporting groups
10797150|NCT04115748|FG000|Participant Flow|Filgotinib 200 mg (Main Study)|Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.
10797151|NCT04115748|FG001|Participant Flow|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
10797152|NCT04115748|FG002|Participant Flow|Adalimumab 40 mg (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
10797153|NCT04115748|FG003|Participant Flow|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797154|NCT04115748|FG004|Participant Flow|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|"Long term extension (LTE):~Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study."
10797155|NCT04115748|FG005|Participant Flow|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
10797156|NCT04115748|FG006|Participant Flow|Filgotinib 200 mg From Adalimumab 40 mg (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
10797157|NCT04115748|FG007|Participant Flow|Filgotinib 100 mg From Adalimumab 40 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
10797158|NCT04115748|FG008|Participant Flow|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
10797159|NCT04115748|FG009|Participant Flow|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
10797160|NCT04115748|OG000|Outcome|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797161|NCT04115748|OG001|Outcome|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
10797162|NCT04115748|OG002|Outcome|Adalimumab (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
10797163|NCT04115748|OG003|Outcome|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797164|NCT04115748|OG002|Outcome|Adalimumab 40 mg (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
10797165|NCT04115748|OG000|Outcome|Filgotinib 200 mg (Main Study)|Participants will receive filgotinib 200 mg orally once daily + placebo to match (PTM) filgotinib 100 mg orally once daily + PTM adalimumab injection every two weeks for 16 weeks.
10797166|NCT04115748|OG001|Outcome|Filgotinib 100 mg (Main Study)|Participants will receive PTM filgotinib 200 mg orally one daily + filgotinib 100 mg orally once daily + PTM adalimumab every two weeks for 16 weeks.
10797167|NCT04115748|OG002|Outcome|Adalimumab (Main Study)|Participants will receive PTM filgotinib 200 mg orally once daily + PTM filgotinib 100 mg orally once daily + adalimumab 40 mg injection every two weeks for 16 weeks.
10797168|NCT04115748|OG003|Outcome|Placebo (Main Study)|Participants will receive PTM filgotinib 200 mg orally once daily + PTM filgotinib 100 mg orally once daily + PTM adalimumab injection every two weeks for 16 weeks.
10797169|NCT04115748|OG001|Outcome|Filgotinib 100 mg (Main Study)|Participants will receive PTM filgotinib 200 mg orally once daily + filgotinib 100 mg orally once daily + PTM adalimumab every two weeks for 16 weeks.
10797170|NCT04115748|EG000|Reported Event|Filgotinib 200 mg (Main Study)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797171|NCT04115748|EG001|Reported Event|Filgotinib 100 mg (Main Study)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
10797172|NCT04115748|EG002|Reported Event|Adalimumab 40 mg (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
11202280|NCT02206776|EG000|Reported Event|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
10797173|NCT04115748|EG003|Reported Event|Placebo (Main Study)|PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
10797174|NCT04115748|EG004|Reported Event|Filgotinib 200 mg From Filgotinib 200 mg (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
10797175|NCT04115748|EG005|Reported Event|Filgotinib 100 mg From Filgotinib 100 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
10797176|NCT04115748|EG006|Reported Event|Filgotinib 200 mg From Adalimumab 40 mg (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
10797177|NCT04115748|EG007|Reported Event|Filgotinib 100 mg From Adalimumab 40 mg (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
10797178|NCT04115748|EG008|Reported Event|Filgotinib 200 mg From Placebo (LTE)|Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
10797179|NCT04115748|EG009|Reported Event|Filgotinib 100 mg From Placebo (LTE)|Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
10797180|NCT04044664|BG000|Baseline|Placebo|Placebo oral capsule: Matching placebo capsules.
10797181|NCT04044664|BG001|Baseline|NYX-783 High Dose (50 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797182|NCT04044664|BG002|Baseline|NYX-783 Low Dose (10 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797183|NCT04044664|BG003|Baseline|Total|Total of all reporting groups
10797184|NCT04044664|FG000|Participant Flow|Placebo|Placebo oral capsule: Matching placebo capsules.
10797185|NCT04044664|FG001|Participant Flow|NYX-783 High Dose (50 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797186|NCT04044664|FG002|Participant Flow|NYX-783 Low Dose (10 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797187|NCT04044664|OG000|Outcome|Placebo|Placebo oral capsule: Matching placebo capsules.
10797188|NCT04044664|OG001|Outcome|NYX-783 High Dose (50 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797189|NCT04044664|OG002|Outcome|NYX-783 Low Dose (10 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797190|NCT04044664|EG000|Reported Event|Placebo|Placebo oral capsule: Matching placebo capsules.
10797191|NCT04044664|EG001|Reported Event|NYX-783 High Dose (50 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797192|NCT04044664|EG002|Reported Event|NYX-783 Low Dose (10 mg QD)|NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
10797193|NCT04009850|BG000|Baseline|Menthol E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
10797194|NCT04009850|BG001|Baseline|Tobacco E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette~E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes"
10797195|NCT04009850|BG002|Baseline|Total|Total of all reporting groups
10797196|NCT04009850|FG000|Participant Flow|Menthol E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
10797197|NCT04009850|FG001|Participant Flow|Tobacco E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette~E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes"
10797198|NCT04009850|OG000|Outcome|Menthol E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
10797199|NCT04009850|OG001|Outcome|Tobacco E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette~E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes"
10797200|NCT04009850|EG000|Reported Event|Menthol E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
10797201|NCT04009850|EG001|Reported Event|Tobacco E-cigarette|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette~E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes"
10797202|NCT03994731|BG000|Baseline|Pegloticase + MTX|Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral MTX 15 mg, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797203|NCT03994731|BG001|Baseline|Pegloticase + Placebo|Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797204|NCT03994731|BG002|Baseline|Total|Total of all reporting groups
11202281|NCT02206776|EG001|Reported Event|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
11202282|NCT02206828|BG000|Baseline|Symbotex Composite Mesh|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797205|NCT03994731|FG000|Participant Flow|Pegloticase + MTX|Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + Immunomodulator (IMM) Period, in addition to oral MTX 15 mg, participants received intravenous (IV) pegloticase 8 mg every 2 weeks (Q2W) for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797206|NCT03994731|FG001|Participant Flow|Pegloticase + Placebo|Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797207|NCT03994731|OG000|Outcome|Pegloticase + MTX|Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral MTX 15 mg, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797208|NCT03994731|OG001|Outcome|Pegloticase + Placebo|Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797209|NCT03994731|EG000|Reported Event|MTX: Methotrexate Tolerability Assessment Period|Participants received open-label oral MTX 15 mg for 2 weeks. 7 participants who were unable to tolerate MTX in this period or who met other exclusion criteria were not randomized and were classified as screen failures per protocol section 9.4.6.3.2.2.
10797210|NCT03994731|EG001|Reported Event|MTX: Run-In Period|Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period.
10797211|NCT03994731|EG002|Reported Event|Placebo: Run-In Period|Participants were randomized to receive blinded oral placebo weekly during the Run-in Period.
10797212|NCT03994731|EG003|Reported Event|Pegloticase + MTX: Pegloticase + IMM Period|Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral MTX 15 mg, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10797213|NCT03994731|EG004|Reported Event|Pegloticase + Placebo: Pegloticase + IMM Period|Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit.
10803311|NCT01517802|FG000|Participant Flow|Abiraterone Acetate + Prednisone/Prednisolone|Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 [NCT00473512], COU-AA-002 [NCT00473746], COU-AA-006 [NCT00910754], COU-AA-206 [NCT01400555], COU-AA-301 [NCT00638690], COU-AA-302 [NCT00887198], COU-AA-BMA [NCT00544440]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
10803312|NCT01517802|OG000|Outcome|Abiraterone Acetate + Prednisone/Prednisolone|Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 [NCT00473512], COU-AA-002 [NCT00473746], COU-AA-006 [NCT00910754], COU-AA-206 [NCT01400555], COU-AA-301 [NCT00638690], COU-AA-302 [NCT00887198], COU-AA-BMA [NCT00544440]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
10803313|NCT01517802|EG000|Reported Event|Abiraterone Acetate + Prednisone/Prednisolone|Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 [NCT00473512], COU-AA-002 [NCT00473746], COU-AA-006 [NCT00910754], COU-AA-206 [NCT01400555], COU-AA-301 [NCT00638690], COU-AA-302 [NCT00887198], COU-AA-BMA [NCT00544440]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
10965779|NCT00883779|EG000|Reported Event|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
11202283|NCT02206828|FG000|Participant Flow|Symbotex Composite Mesh|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach.
10797214|NCT03963895|BG000|Baseline|AB002 (E-WE-thrombin) Dose 1|"Participants received a single dose of 1.5 mcg/kg E-WE thrombin.~AB002 Dose 1: AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion"
10797215|NCT03963895|BG001|Baseline|AB002 (E-WE-thrombin) Dose 2|"Participants received a single dose of 3.0 mcg/kg E-WE thrombin.~AB002 Dose 2: AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion"
10797216|NCT03963895|BG002|Baseline|Placebo|"Participants received a single dose of placebo~placebo: placebo administered on Day 1 as a single intravenous infusion"
10797217|NCT03963895|BG003|Baseline|Total|Total of all reporting groups
10797218|NCT03963895|FG000|Participant Flow|AB002 (E-WE-thrombin) Dose 1|"Participants received a single dose of 1.5 mcg/kg E-WE thrombin.~AB002 Dose 1: AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion"
10797219|NCT03963895|FG001|Participant Flow|AB002 (E-WE-thrombin) Dose 2|"Participants received a single dose of 3.0 mcg/kg E-WE thrombin.~AB002 Dose 2: AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion"
10797220|NCT03963895|FG002|Participant Flow|Placebo|"Participants received a single dose of placebo~placebo: placebo administered on Day 1 as a single intravenous infusion"
10797221|NCT03963895|OG000|Outcome|AB002 (E-WE-thrombin) Dose 1|"Participants received a single dose of 1.5 mcg/kg E-WE thrombin.~AB002 Dose 1: AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion"
10797222|NCT03963895|OG001|Outcome|AB002 (E-WE-thrombin) Dose 2|"Participants received a single dose of 3.0 mcg/kg E-WE thrombin.~AB002 Dose 2: AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion"
10797223|NCT03963895|OG002|Outcome|Placebo|"Participants received a single dose of placebo~placebo: placebo administered on Day 1 as a single intravenous infusion"
10797224|NCT03963895|EG000|Reported Event|AB002 (E-WE-thrombin) Dose 1|"Participants received a single dose of 1.5 mcg/kg E-WE thrombin.~AB002 Dose 1: AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion"
10797225|NCT03963895|EG001|Reported Event|AB002 (E-WE-thrombin) Dose 2|"Participants received a single dose of 3.0 mcg/kg E-WE thrombin.~AB002 Dose 2: AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion"
10797226|NCT03963895|EG002|Reported Event|Placebo|"Participants received a single dose of placebo~placebo: placebo administered on Day 1 as a single intravenous infusion"
10797227|NCT03924622|BG000|Baseline|Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest|"Intervention: Mepilex Study surface Litter + WELP mattress pad with 30 degree backrest.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797228|NCT03924622|BG001|Baseline|Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest|"Intervention: Control (no Mepilex)~Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex"
10797229|NCT03924622|BG002|Baseline|Group 3: Mepilex on VSB on WELP Mattress|"Intervention: Mepilex Litter + WELP mattress + Vacuum Spineboard.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797230|NCT03924622|BG003|Baseline|Group 4: Without Mepilex on VSB on WELP Mattress|"Intervention: Control (no Mepilex)~Litter + WELP mattress + Vacuum Spineboard. No Mepilex"
10797231|NCT03924622|BG004|Baseline|Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter|Intervention: LiquiCell mat Talon litter LiquiCell: LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches. Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up. LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom. The overlay is positioned from the shoulders to below the hips to minimize shear.
10797232|NCT03924622|BG005|Baseline|Group 6: PFC Without LiquiCell on Talon Litter|"Intervention: Control (no LiquiCell)~Talon litter"
10797233|NCT03924622|BG006|Baseline|Total|Total of all reporting groups
10797234|NCT03924622|FG000|Participant Flow|Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest|"Intervention: Mepilex~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797235|NCT03924622|FG001|Participant Flow|Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest|Intervention: Control (no Mepilex)
10797236|NCT03924622|FG002|Participant Flow|Group 3: Mepilex on VSB on WELP Mattress|"Intervention: Mepilex~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797237|NCT03924622|FG003|Participant Flow|Group 4: Without Mepilex on VSB on WELP Mattress|Intervention: Control (no Mepilex)
10797238|NCT03924622|FG004|Participant Flow|Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter|"Intervention: LiquiCell mat~LiquiCell: LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches. Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up. LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom. The overlay is positioned from the shoulders to below the hips to minimize shear."
10797239|NCT03924622|FG005|Participant Flow|Group 6: PFC Without LiquiCell on Talon Litter|Intervention: Control (no LiquiCell)
10797240|NCT03924622|OG000|Outcome|Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest|"Intervention: Mepilex Study surface Litter + WELP mattress pad with 30 degree backrest.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797241|NCT03924622|OG001|Outcome|Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest|"Intervention: Control (no Mepilex)~Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex"
10797242|NCT03924622|OG002|Outcome|Group 3: Mepilex on VSB on WELP Mattress|"Intervention: Mepilex Litter + WELP mattress + Vacuum Spineboard.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797243|NCT03924622|OG003|Outcome|Group 4: Without Mepilex on VSB on WELP Mattress|"Intervention: Control (no Mepilex)~Litter + WELP mattress + Vacuum Spineboard. No Mepilex"
10797244|NCT03924622|OG004|Outcome|Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter|Intervention: LiquiCell mat Talon litter LiquiCell: LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches. Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up. LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom. The overlay is positioned from the shoulders to below the hips to minimize shear.
10797245|NCT03924622|OG005|Outcome|Group 6: PFC Without LiquiCell on Talon Litter|"Intervention: Control (no LiquiCell)~Talon litter"
10797246|NCT03924622|EG000|Reported Event|Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest|"Intervention: Mepilex Study surface Litter + WELP mattress pad with 30 degree backrest.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797247|NCT03924622|EG001|Reported Event|Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest|"Intervention: Control (no Mepilex)~Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex"
10797248|NCT03924622|EG002|Reported Event|Group 3: Mepilex on VSB on WELP Mattress|"Intervention: Mepilex Litter + WELP mattress + Vacuum Spineboard.~Mepilex: Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum."
10797249|NCT03924622|EG003|Reported Event|Group 4: Without Mepilex on VSB on WELP Mattress|"Intervention: Control (no Mepilex)~Litter + WELP mattress + Vacuum Spineboard. No Mepilex"
10797250|NCT03924622|EG004|Reported Event|Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter|Intervention: LiquiCell mat Talon litter LiquiCell: LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches. Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up. LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom. The overlay is positioned from the shoulders to below the hips to minimize shear.
10797251|NCT03924622|EG005|Reported Event|Group 6: PFC Without LiquiCell on Talon Litter|"Intervention: Control (no LiquiCell)~Talon litter"
10797252|NCT03905811|BG000|Baseline|Active|"Terazosin administered 5 mg once daily p.o. for 12 weeks~Terazosin 5 MG: 5 milligrams by mouth daily at bedtime"
10797253|NCT03905811|BG001|Baseline|Placebo|"Placebo administered once daily p.o. for 12 weeks~Placebo oral capsule: 1 capsule by mouth daily at bedtime"
10797254|NCT03905811|BG002|Baseline|Total|Total of all reporting groups
10797255|NCT03905811|FG000|Participant Flow|Active|"Terazosin administered 5 mg once daily p.o. for 12 weeks~Terazosin 5 MG: 5 milligrams by mouth daily at bedtime"
10797256|NCT03905811|FG001|Participant Flow|Placebo|"Placebo administered once daily p.o. for 12 weeks~Placebo oral capsule: 1 capsule by mouth daily at bedtime"
10797257|NCT03905811|OG000|Outcome|Active|"Terazosin administered 5 mg once daily p.o. for 12 weeks~Terazosin 5 MG: 5 milligrams by mouth daily at bedtime"
10797258|NCT03905811|OG001|Outcome|Placebo|"Placebo administered once daily p.o. for 12 weeks~Placebo oral capsule: 1 capsule by mouth daily at bedtime"
10797259|NCT03905811|EG000|Reported Event|Active|"Terazosin administered 5 mg once daily p.o. for 12 weeks~Terazosin 5 MG: 5 milligrams by mouth daily at bedtime"
10797260|NCT03905811|EG001|Reported Event|Placebo|"Placebo administered once daily p.o. for 12 weeks~Placebo oral capsule: 1 capsule by mouth daily at bedtime"
10797261|NCT03867396|BG000|Baseline|All Participants|All participants in crossover study.
10797262|NCT03867396|FG000|Participant Flow|Cochlear Implant (CI) and Hearing Aid, Then CI and CROS, Then CI Alone|"Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.~Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.~Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear."
10797263|NCT03867396|FG001|Participant Flow|Cochlear Implant (CI) and Hearing Aid, Then CI Alone, Then CI and CROS|"Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.Hearing Aid: Advanced Bionics Naida hearing aid.~Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.~Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS."
10797264|NCT03867396|FG002|Participant Flow|Cochlear Implant (CI) and CROS, Then CI and Hearing Aid, Then CI Alone.|"Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.~Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.~Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear."
10797265|NCT03867396|FG003|Participant Flow|Cochlear Implant (CI) and CROS, Then CI Alone, Then CI and Hearing Aid|"Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.~Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.~Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid."
11383916|NCT00896389|EG001|Reported Event|HCTZ|After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
11383917|NCT00880893|BG000|Baseline|CYD Dengue Vaccine Group|Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
11383918|NCT00880893|BG001|Baseline|Placebo Group|All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
11383919|NCT00880893|BG002|Baseline|Total|Total of all reporting groups
11383920|NCT00880893|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
11383921|NCT00880893|FG001|Participant Flow|Placebo Group|All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
11383922|NCT00880893|OG000|Outcome|CYD Dengue Vaccine Group|Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
11383923|NCT00880893|OG001|Outcome|Placebo Group|All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
11383924|NCT00880893|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
11383925|NCT00880893|EG001|Reported Event|Placebo Group|All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
11383926|NCT00866918|BG000|Baseline|Standard Risk|WBC<10,000/MicroLiter
11202284|NCT02206828|OG000|Outcome|Recurence Rate at 1 Month|Recurrence rate following patients treated for ventral hernia
11202285|NCT02206828|OG001|Outcome|Recurrence Rate at 1 Year|Recurrence rate following patients treated for ventral hernia
11383927|NCT00866918|BG001|Baseline|High Risk|WBC>=10,000/MicroLiter
11383928|NCT00866918|BG002|Baseline|Total|Total of all reporting groups
11383929|NCT00866918|FG000|Participant Flow|Standard Risk|WBC<10,000/MicroLiter
11383930|NCT00866918|FG001|Participant Flow|High Risk|WBC>=10,000/MicroLiter
11383931|NCT00866918|OG000|Outcome|Standard Risk|WBC<10,000/MicroLiter
11383932|NCT00866918|OG001|Outcome|High Risk|WBC>=10,000/MicroLiter
11383933|NCT00866918|EG000|Reported Event|Standard Risk|WBC<10,000/MicroLiter
11383934|NCT00866918|EG001|Reported Event|High Risk|WBC>=10,000/MicroLiter
11383944|NCT00587301|BG000|Baseline|Lap-Band|"Lap-band surgery in treatment of morbidly obese adolescents~Lap-Band: Obesity and adolescents"
11383945|NCT00587301|FG000|Participant Flow|Lap-Band|"Lap-band surgery in treatment of morbidly obese adolescents~Lap-Band: Obesity and adolescents"
11383946|NCT00587301|OG000|Outcome|Lap-Band|"Lap-band surgery in treatment of morbidly obese adolescents~Lap-Band: Obesity and adolescents"
11383947|NCT00587301|EG000|Reported Event|Lap-Band|"Lap-band surgery in treatment of morbidly obese adolescents~Lap-Band: Obesity and adolescents"
11383948|NCT00579527|BG000|Baseline|Cultured Thymus Tissue Implantation With Immunosuppression|Participants enrolled into cultured thymus tissue for implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell number and function.
11383949|NCT00579527|FG000|Participant Flow|Cultured Thymus Tissue Implantation w/ Immunosuppression|"Participants enrolled in cultured thymus tissue implantation (CTTI) with immunosuppression were given immunosuppression based on results of flow cytometry without consideration of whether a parathyroid transplant would be given.~No participants were enrolled into Arm 2. No subjects received a parathyroid transplant.~No specific dose of cultured thymus tissue was assigned. The dose was the number of grams of cultured thymus tissue divided by the weight of the recipient in kg or per square meter of body surface area of the participant.~There was one administration of cultured thymus tissue. The dosage form was cultured thymus tissue."
11383950|NCT00579527|OG000|Outcome|Cultured Thymus Tissue With Immunosuppression|Participants enrolled into cultured thymus tissue for Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
11383951|NCT00579527|OG000|Outcome|Cultured Thymus Tissue Implantation With Immunosuppression|Participants enrolled into Cultured Thymus Tissue Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function.
10797266|NCT03867396|FG004|Participant Flow|Cochlear Implant (CI) Alone, Then CI and CROS, Then CI and Hearing Aid|"Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.~Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.~Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid."
10797267|NCT03867396|FG005|Participant Flow|Cochlear Implant (CI) Alone, Then CI and Hearing Aid, Then CI and CROS|"Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.~Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.~Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS."
10797268|NCT03867396|OG000|Outcome|No Contralateral Device (Cochlear Implant Alone)|"Subject only uses the cochlear implant; hearing on the contralateral side is unaided.~Cochlear Implant Alone: No hearing device on contralateral ear"
10797269|NCT03867396|OG001|Outcome|Cochlear Implant and Contralateral Device|Subject wears a contralateral device
10797270|NCT03867396|OG000|Outcome|No Contralateral Device (Cochlear Implant and CROS)|Cochlear Implant and CROS Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.
10797271|NCT03867396|OG001|Outcome|Contralateral Device (Cochlear Implant and CROS)|Cochlear Implant and CROS plus contralateral device.
10797272|NCT03867396|OG000|Outcome|No Contralateral Device (Cochlear Implant and Hearing Aid)|"Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.~Hearing Aid: Advanced Bionics Naida hearing aid"
10797273|NCT03867396|OG001|Outcome|Contralateral Device (Cochlear Implant and Hearing Aid)|"Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.~Subject wears a Contralateral Device"
10797274|NCT03867396|EG000|Reported Event|Cochlear Implant and Hearing Aid|"Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.~Hearing Aid: Advanced Bionics Naida hearing aid"
10797275|NCT03867396|EG001|Reported Event|Cochlear Implant Alone|"Subject only uses the cochlear implant; hearing on the contralateral side is unaided.~Cochlear Implant Alone: No hearing device on contralateral ear"
10797276|NCT03867396|EG002|Reported Event|Cochlear Implant and CROS|"Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.~CROS: Advanced Bionics CROS"
10797277|NCT03807843|BG000|Baseline|V184|Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.
10797278|NCT03807843|BG001|Baseline|Placebo|Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
10797279|NCT03807843|BG002|Baseline|Total|Total of all reporting groups
10797280|NCT03807843|FG000|Participant Flow|V184|Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.
10797281|NCT03807843|FG001|Participant Flow|Placebo|Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
10797282|NCT03807843|OG000|Outcome|V184|Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.
10797283|NCT03807843|OG001|Outcome|Placebo|Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
10797284|NCT03807843|EG000|Reported Event|V184|Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.
10797285|NCT03807843|EG001|Reported Event|Placebo|Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
10797286|NCT03802513|BG000|Baseline|Individualized Physiotherapy|"This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.~Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home."
10797287|NCT03802513|FG000|Participant Flow|Individualized Physiotherapy|"This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.~Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home."
10797288|NCT03802513|OG000|Outcome|Individualized Physiotherapy|"This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.~Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home."
10797289|NCT03802513|EG000|Reported Event|Individualized Physiotherapy|"This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.~Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home."
10797290|NCT03681184|BG000|Baseline|Placebo|Lumasiran-matching placebo was administered SC at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg, at Months 6, 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797291|NCT03681184|BG001|Baseline|Lumasiran|Lumasiran was administered SC, 3.0 mg/kg, at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg at Month 6, and lumasiran-matching placebo SC at Months 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797292|NCT03681184|BG002|Baseline|Total|Total of all reporting groups
11202286|NCT02206828|OG002|Outcome|Recurrence Rate at 2 Year|Recurrence rate following patients treated for ventral hernia
11202287|NCT02206828|OG000|Outcome|VAS Pain Assessment Day 0|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797293|NCT03681184|FG000|Participant Flow|Placebo|Lumasiran-matching placebo (normal saline [0.9% NaCl]) was administered subcutaneously (SC) at Day 1 and Months 1, 2 and 3 during the 6-Month Double-blind (DB) Period, followed by lumasiran SC, 3.0 mg/kg, at Months 6, 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month Open-label Extension (OLE) period.
10797294|NCT03681184|FG001|Participant Flow|Lumasiran|Lumasiran was administered SC, 3.0 mg/kg, at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg at Month 6, and lumasiran-matching placebo SC at Months 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797295|NCT03681184|OG000|Outcome|Placebo|Lumasiran-matching placebo was administered SC at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg, at Months 6, 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797296|NCT03681184|OG001|Outcome|Lumasiran|Lumasiran was administered SC, 3.0 mg/kg, at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg at Month 6, and lumasiran-matching placebo SC at Months 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797297|NCT03681184|EG000|Reported Event|Placebo|Lumasiran-matching placebo was administered SC at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg, at Months 6, 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797298|NCT03681184|EG001|Reported Event|Lumasiran|Lumasiran was administered SC, 3.0 mg/kg, at Day 1 and Months 1, 2 and 3 during the 6-Month DB Period, followed by lumasiran SC, 3.0 mg/kg at Month 6, and lumasiran-matching placebo SC at Months 7 and 8 during the 3-Month Blinded Treatment Extension Period, followed by lumasiran SC, 3.0 mg/kg, at Month 9 and then every three months during the 51-Month OLE period.
10797299|NCT03679767|BG000|Baseline|Melanoma|Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
10797300|NCT03679767|BG001|Baseline|Non-small Cell Lung Cancer|Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797301|NCT03679767|BG002|Baseline|Urethelial Carcinoma|Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797302|NCT03679767|BG003|Baseline|Renal Cell Carcinoma|Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797303|NCT03679767|BG004|Baseline|Total|Total of all reporting groups
10797304|NCT03679767|FG000|Participant Flow|Melanoma|Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
10797305|NCT03679767|FG001|Participant Flow|Non-small Cell Lung Cancer|Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797306|NCT03679767|FG002|Participant Flow|Urethelial Carcinoma|Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797307|NCT03679767|FG003|Participant Flow|Renal Cell Carcinoma|Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797308|NCT03679767|OG000|Outcome|Melanoma|Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
10797309|NCT03679767|OG001|Outcome|Non-small Cell Lung Cancer|Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797310|NCT03679767|OG002|Outcome|Urethelial Carcinoma|Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797311|NCT03679767|OG003|Outcome|Renal Cell Carcinoma|Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797312|NCT03679767|OG000|Outcome|All Participants|Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797313|NCT03679767|EG000|Reported Event|Melanoma|Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
10797314|NCT03679767|EG001|Reported Event|Non-small Cell Lung Cancer|Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797315|NCT03679767|EG002|Reported Event|Urethelial Carcinoma|Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797316|NCT03679767|EG003|Reported Event|Renal Cell Carcinoma|Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
10797317|NCT03679767|EG004|Reported Event|Total|Total
10797318|NCT03576716|BG000|Baseline|Healthy Controls|Healthy Controls (n = 10)
10797319|NCT03576716|BG001|Baseline|CKD Group|CKD Group (n = 8)
10797320|NCT03576716|BG002|Baseline|Total|Total of all reporting groups
10797321|NCT03576716|FG000|Participant Flow|Healthy Controls|Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2)
10797322|NCT03576716|FG001|Participant Flow|CKD Group|CKD group defined as those with eGFR (<60 ml/min per 1.73 m2)
10797323|NCT03576716|OG000|Outcome|Healthy Controls|Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2)
10797324|NCT03576716|OG001|Outcome|CKD Group|CKD group defined as those with eGFR (<60ml/min per 1.73m2)
10797325|NCT03576716|OG000|Outcome|Healthy Controls|Healthy controls defined as normal eGFR (>60ml/min per 1.73m2)
10797326|NCT03576716|EG000|Reported Event|All Participants|All Participants (N = 18). AEs were not collected by arm but altogether.
11202288|NCT02206828|OG001|Outcome|VAS Pain Assessment Day 1|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11383952|NCT00579527|EG000|Reported Event|Cultured Thymus Tissue Implantation With Immunosuppression|Participants enrolled into Cultured Thymus Tissue Implantation (previously described as transplantation) with immunosuppression were given immunosuppression based on the subject's pre-implantation T cell numbers and function. All adverse events were combined for this analysis regardless of the immunosuppression used.
11383953|NCT00576836|BG000|Baseline|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (CTTI) (previously described as transplantation) is done using allogenic cultured postnatal tissue from unrelated donors.
11383954|NCT00576836|FG000|Participant Flow|Cultured Thymus Tissue Implantation w Parathyroid Transplant|"Cultured Thymus Tissue Implantation (CTTI): Thymus tissue (from unrelated donor), thymus donor and thymus donor's birth mother screened for safety. CTTI done under general anesthesia. Cultured thymus tissue is implanted into quadriceps. Thymus dose at least 4grams/m2 body surface area (0.2 grams/kg body weight) and not >18 grams/m2 body surface area (1.0 grams/kg body weight). At time of CTTI, skin biopsy is obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy done to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. Allograft biopsy not done if subject medically unstable. Post-CTTI, subjects followed by immune evaluations, using blood samples.~Parathyroid Tissue for Transplantation: If both parents meet eligibility criteria, the parent chosen for donation will be the one sharing the parental HLA (Human Leukocyte Antigen)-DR allele that is not in the recipient but is in the thymus donor."
11383955|NCT00576836|FG001|Participant Flow|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (CTTI): Thymus tissue (from unrelated donor), thymus donor, and thymus donor's birth mother screened for safety. CTTI is done under general anesthesia. Cultured thymus tissue is implanted into quadriceps. Cultured thymus tissue dose at least 4grams/m2 body surface area (0.2 grams/kg body weight) and not >18 grams/m2 body surface area (1.0 grams/kg body weight). At time of CTTI, skin biopsy obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy done to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy is done to look for T cell clonal populations. (Allograft biopsy not done if subject medically unstable.) Post-CTTI, subjects followed by immune evaluations, using blood samples.
11383956|NCT00576836|OG000|Outcome|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (CTTI) (previously described as transplantation) is done using allogenic cultured postnatal tissue from unrelated donors.
11383957|NCT00576836|EG000|Reported Event|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (CTTI) (previously described as transplantation) is done using allogenic cultured postnatal tissue from unrelated donors.
11383958|NCT00576407|BG000|Baseline|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation is done using allogeneic cultured postnatal thymus tissue from unrelated donors.
11383959|NCT00576407|FG000|Participant Flow|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated donors.
11383960|NCT00576407|OG000|Outcome|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated donors.
11383961|NCT00576407|OG000|Outcome|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (previously described as transplantation)is done using allogeneic cultured postnatal tissue from unrelated donors.
11383962|NCT00576407|EG000|Reported Event|Cultured Thymus Tissue Implantation|Cultured Thymus Tissue Implantation (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated donors.
10797327|NCT03500692|BG000|Baseline|MitraClip NT System|"Percutaneous mitral valve repair using MitraClip NT System~MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System"
11383963|NCT00557193|BG000|Baseline|All Patients|All patients for Induction
11383964|NCT00557193|FG000|Participant Flow|Induction (All Patients)|All Patients for Induction (not assigned).
11383965|NCT00557193|FG001|Participant Flow|Arm A (Standard Risk MLL-G)|"Eligible patients with MLL-G (germline, or non-rearranged)~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383966|NCT00557193|FG002|Participant Flow|Arm B (IR/HR MLL-R Chemotherapy)|"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383967|NCT00557193|FG003|Participant Flow|Arm C (Safety/ Dose Level 1)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
11383968|NCT00557193|FG004|Participant Flow|ARM C (Safety/ Dose Level 2)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383969|NCT00557193|FG005|Participant Flow|Arm C (Efficacy/ Dose Level 2)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383970|NCT00557193|OG000|Outcome|Arm C (Safety/Efficacy Dose Level 2)|Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383971|NCT00557193|OG000|Outcome|Arm B (IR/HR MLL-R Chemotherapy)|"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383972|NCT00557193|OG001|Outcome|Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)|"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Lestaurtinib: Given PO~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383973|NCT00557193|OG000|Outcome|Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)|Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL1 (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
11383974|NCT00557193|OG001|Outcome|Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)|Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383975|NCT00557193|OG000|Outcome|Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)|"Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Lestaurtinib: Given PO~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383976|NCT00557193|OG000|Outcome|Arm A (Standard Risk MLL-G)|"Population Description: Eligible patients with MLL-G (germline, or non-rearranged)~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383977|NCT00557193|OG001|Outcome|Arm B (IR/HR MLL-R Chemotherapy)|"Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383978|NCT00557193|OG002|Outcome|Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)|"Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Lestaurtinib: Given PO~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383979|NCT00557193|OG000|Outcome|Arm A (MRD Negative)|Arm A, standard risk MLL-G
11383980|NCT00557193|OG001|Outcome|Arm A (MRD Positive)|Arm A, standard risk MLL-G
10797328|NCT03500692|FG000|Participant Flow|MitraClip NT System|"Percutaneous mitral valve repair using MitraClip NT System~MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System"
10797329|NCT03500692|OG000|Outcome|MitraClip NT System|"Percutaneous mitral valve repair using MitraClip NT System~MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System"
10797330|NCT03500692|EG000|Reported Event|MitraClip NT System|"Percutaneous mitral valve repair using MitraClip NT System~MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System"
10797331|NCT03367819|BG000|Baseline|mCRPC: Isatuximab + REGN2810|Participants with mCRPC received intravenous (IV) infusion of isatuximab 10 milligrams per kilogram (mg/kg) once weekly (QW) for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
11383981|NCT00557193|OG002|Outcome|Arm B (MRD Negative)|Arm B, IR/HR MLL-R chemotherapy
11383982|NCT00557193|OG003|Outcome|Arm B (MRD Positive)|Arm B, IR/HR MLL-R chemotherapy
11383983|NCT00557193|OG004|Outcome|Arm C (MRD Negative)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib
11383984|NCT00557193|OG005|Outcome|Arm C (MRD Positive)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib
11383985|NCT00557193|OG000|Outcome|Arm A (Standard Risk MLL-G)|"Eligible patients with MLL-G (germline, or non-rearranged)~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11202289|NCT02206828|OG002|Outcome|VAS Pain Assessment Day 8|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11383986|NCT00557193|EG000|Reported Event|Induction (All Patients)|All Patients for Induction (not assigned)
11383987|NCT00557193|EG001|Reported Event|Post Induction (Follow-up Only)|Post-Induction patients that did not receive therapy
11383988|NCT00557193|EG002|Reported Event|Arm A (Standard Risk MLL-G)|"Population Description: Eligible patients with MLL-G (germline, or non-rearranged)~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383989|NCT00557193|EG003|Reported Event|Arm B (IR/HR MLL-R Chemotherapy)|"Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.~Asparaginase: Given IV, IM, or PO~Cyclophosphamide: Given IV~Cytarabine: Given IV or IT~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IV, IT, or PO~Methylprednisolone: Given IV~Pegaspargase: Given IM~Pharmacological Study: Correlative studies~Prednisone: Given PO~Therapeutic Hydrocortisone: Given IT~Vincristine Sulfate: Given IV"
11383990|NCT00557193|EG004|Reported Event|Arm C (Safety/ Dose Level 1)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
11383991|NCT00557193|EG005|Reported Event|Arm C (Safety/ Dose Level 2)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383992|NCT00557193|EG006|Reported Event|Arm C (Efficacy/ Dose Level 2)|Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
11383993|NCT00547339|BG000|Baseline|Phase 1: SBRT- 45 Gy(SBRT) 45 Gy.|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
11383994|NCT00547339|BG001|Baseline|Phase 1: SBRT- 47.5 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
11383995|NCT00547339|BG002|Baseline|Phase 1: Stereotactic Body Radiation Therapy (SBRT) 50 Gy.|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
11383996|NCT00547339|BG003|Baseline|Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
11383997|NCT00547339|BG004|Baseline|Total|Total of all reporting groups
11383998|NCT00547339|FG000|Participant Flow|Phase 1: Dose Escalation 45 Gy Arm|Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 45 Gy).
11383999|NCT00547339|FG001|Participant Flow|Phase 1: Dose Escalation 47.5 Gy Arm|Dose escalation portion will be 9.5 Gy per fraction for 5 fractions (total dose = 47.5 Gy).
11384000|NCT00547339|FG002|Participant Flow|Phase 1: Dose Escalation 50 Gy Arm|Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
11384001|NCT00547339|FG003|Participant Flow|Phase 2: Dose Escalation 50 Gy Arm|Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
11384002|NCT00547339|OG000|Outcome|Phase 1: SBRT- 45 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
11384003|NCT00547339|OG001|Outcome|Phase 1: SBRT- 47.5 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
11384004|NCT00547339|OG002|Outcome|Phase 1: SBRT- 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
11384005|NCT00547339|OG003|Outcome|Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
11384006|NCT00547339|OG000|Outcome|Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
11384007|NCT00547339|OG000|Outcome|Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
11384008|NCT00547339|OG002|Outcome|Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
11384009|NCT00547339|OG000|Outcome|Phase 1: SBRT - 45 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
11384010|NCT00547339|OG001|Outcome|Phase 1: SBRT- 47.5 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is escalated to 47.5 Gy in Phase 1
11384011|NCT00547339|OG002|Outcome|Phase 1: SBRT- 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is escalated to 50 Gy in Phase 1
11384012|NCT00547339|OG003|Outcome|Phase 2: SBRT - 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is escalated to 50 Gy in Phase 2
11384013|NCT00547339|OG003|Outcome|Phase 2: SBRT- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
11384014|NCT00547339|OG003|Outcome|Phase 2: SBRT - 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is escalated - 50 Gy in Phase 2
11384015|NCT00547339|EG000|Reported Event|Phase 1: SBRT- 45 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
11384016|NCT00547339|EG001|Reported Event|Phase 1: SBRT- 47.5 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
11384017|NCT00547339|EG002|Reported Event|Phase 1: SBRT- 50 Gy|The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
11384018|NCT00547339|EG003|Reported Event|Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy|The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
11384019|NCT00531232|BG000|Baseline|Clofarabine 55 mg/Day|Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384020|NCT00531232|BG001|Baseline|Clofarabine 35 mg/Day|Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384021|NCT00531232|BG002|Baseline|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384022|NCT00531232|BG003|Baseline|Total|Total of all reporting groups
11384023|NCT00531232|FG000|Participant Flow|Clofarabine 55 mg/Day|Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384024|NCT00531232|FG001|Participant Flow|Clofarabine 35 mg/Day|Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384025|NCT00531232|FG002|Participant Flow|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384026|NCT00531232|OG000|Outcome|Clofarabine 35 mg/Day|Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384027|NCT00531232|OG001|Outcome|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384028|NCT00531232|OG000|Outcome|Clofarabine 55 mg/Day|Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384029|NCT00531232|OG001|Outcome|Clofarabine 35 mg/Day|Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384030|NCT00531232|OG002|Outcome|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384031|NCT00531232|OG002|Outcome|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384032|NCT00531232|EG000|Reported Event|Clofarabine 25 mg/Day|Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384033|NCT00531232|EG001|Reported Event|Clofarabine 35 mg/Day|Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384034|NCT00531232|EG002|Reported Event|Clofarabine 55 mg/Day|Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
11384035|NCT00379340|BG000|Baseline|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
11384036|NCT00379340|BG001|Baseline|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
11384037|NCT00379340|BG002|Baseline|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
11384038|NCT00379340|BG003|Baseline|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
10797332|NCT03367819|BG001|Baseline|NSCLC: Isatuximab + REGN2810|Participants with NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
11384039|NCT00379340|BG004|Baseline|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
11384040|NCT00379340|BG005|Baseline|Total|Total of all reporting groups
11384041|NCT00379340|FG000|Participant Flow|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
11384042|NCT00379340|FG001|Participant Flow|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
11384043|NCT00379340|FG002|Participant Flow|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
11384044|NCT00379340|FG003|Participant Flow|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
11384045|NCT00379340|FG004|Participant Flow|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
11384046|NCT00379340|OG000|Outcome|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
11384047|NCT00379340|OG000|Outcome|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|"Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
11384048|NCT00379340|OG000|Outcome|Stage III/IV With LOH 1p and 16q Treated With Regimen M|"Stage III/IV with LOH 1p and 16q treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
11384049|NCT00379340|OG001|Outcome|Stage IV With Non-lung Disease Treated With Regimen M|"Stage IV with non-lung disease treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
11384050|NCT00379340|OG000|Outcome|Lung Mets <= 1cm|Lung mets <= 1cm
11196176|NCT02163447|OG004|Outcome|Monthly DP Pregnancy / Monthly DP Infancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11196177|NCT02163447|EG000|Reported Event|Mothers - 3 Dose SP|Women were given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, DP placebo was used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and DP placebo) followed by one pill on days 2 and 3 (DP placebo).
11196178|NCT02163447|EG001|Reported Event|Mothers - 3 Dose DP|Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, SP and DP placebos were used to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP placebo).
11196179|NCT02163447|EG002|Reported Event|Mothers - Monthly DP|Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) monthly. In addition, SP placebo to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP).
11384051|NCT00379340|OG001|Outcome|Lung Mets > 1cm|Lung mets > 1cm
11384052|NCT00379340|EG000|Reported Event|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
11384053|NCT00379340|EG001|Reported Event|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
11384054|NCT00379340|EG002|Reported Event|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
11384055|NCT00379340|EG003|Reported Event|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
11384056|NCT00379340|EG004|Reported Event|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
11196180|NCT02163447|EG003|Reported Event|Infants - Monthly DP|DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines.
11196181|NCT02163447|EG004|Reported Event|Infants - 3 Monthly DP|DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines. Infants received placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.
11196182|NCT02163486|BG000|Baseline|Group U (UNIQUE)|"Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.~Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff."
11196183|NCT02163486|BG001|Baseline|Group I (I-GEL ): Group I-GEL|"Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For > 90 kg no.5. I-GEL~I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.~I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc"
11196184|NCT02163486|BG002|Baseline|Total|Total of all reporting groups
11202290|NCT02206828|OG003|Outcome|VAS Pain Assessment Month 1|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11384057|NCT00304070|BG000|Baseline|Stratum 1|Stage I Disease (surgery, observation)
11384058|NCT00304070|BG001|Baseline|Stratum 2|Stage II Disease (surgery, observation)
11384059|NCT00304070|BG002|Baseline|Stratum 3|Stage III OR IV Disease (chemotherapy)
11384060|NCT00304070|BG003|Baseline|Total|Total of all reporting groups
11384061|NCT00304070|FG000|Participant Flow|Stratum 1|Stage I Disease (surgery, observation)
10797333|NCT03367819|BG002|Baseline|Total Title|
10797334|NCT03367819|FG000|Participant Flow|mCRPC: Isatuximab + REGN2810|Participants with mCRPC received intravenous (IV) infusion of isatuximab 10 milligrams per kilogram (mg/kg) once weekly (QW) for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
11384062|NCT00304070|FG001|Participant Flow|Stratum 2|Stage II Disease (surgery, observation)
11384063|NCT00304070|FG002|Participant Flow|Stratum 3|Stage III OR IV Disease (chemotherapy)
11384064|NCT00304070|OG000|Outcome|Stratum 1|Stage I Disease (surgery, observation)
11384065|NCT00304070|OG001|Outcome|Stratum 2|Stage II Disease (surgery, observation)
11384066|NCT00304070|OG002|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
11384067|NCT00304070|OG000|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
11384068|NCT00304070|OG000|Outcome|All Patients|The complication rate is estimated as the proportion of evaluable patients that have a complication as it relates to surgery.
11384069|NCT00304070|OG000|Outcome|All Patients|Regardless of Arm/Group assignment, the frequency reflects the total number of patients who had lymph node involvement by imaging at study enrollment.
11384070|NCT00304070|OG000|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients from whom blood was obtained as well as the frequency of the relevant mutation in each group.
11384071|NCT00304070|OG000|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients who had surgery at study enrollment and have A43 del33bp mutation of (beta)-catenins.
11384072|NCT00304070|OG000|Outcome|All Patients|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.
10797335|NCT03367819|FG001|Participant Flow|NSCLC: Isatuximab + REGN2810|Participants with NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
11196185|NCT02163486|FG000|Participant Flow|Group U (UNIQUE)|"Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before LMA-U is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-Unique cuff was completely deflated. Group U (UNIQUE): Group Laryngeal Mask Airway-Unique.~Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff."
11196186|NCT02163486|FG001|Participant Flow|Group I (I-GEL ): Group I-GEL|"Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For > 90 kg no.5. I-GEL~I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.~I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc"
11196187|NCT02163486|OG000|Outcome|Group U (UNIQUE)|"Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.~Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff."
11196188|NCT02163486|OG001|Outcome|Group I (I-GEL ): Group I-GEL|"Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For > 90 kg no.5. I-GEL~I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.~I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc"
11196189|NCT02163486|EG000|Reported Event|Group U (UNIQUE)|"Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.~Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff."
11196190|NCT02163486|EG001|Reported Event|Group I (I-GEL ): Group I-GEL|"Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For > 90 kg no.5. I-GEL~I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.~I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc"
11196191|NCT02163499|BG000|Baseline|Acute Phase: ZS|
11196192|NCT02163499|FG000|Participant Flow|Subject Disposition|All Screened Subjects
11196193|NCT02163499|OG000|Outcome|Proportion|Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
11196194|NCT02163499|OG000|Outcome|Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12|
11196195|NCT02163499|OG000|Outcome|Percentage|Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
11196196|NCT02163499|OG000|Outcome|Percentage|Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
11196197|NCT02163499|EG000|Reported Event|Acute Phase: ZS|
11196198|NCT02163499|EG001|Reported Event|Extended Dosing Phase: ZS|
11196199|NCT02163538|BG000|Baseline|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
11196200|NCT02163538|BG001|Baseline|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
11196201|NCT02163538|BG002|Baseline|Total|Total of all reporting groups
11196202|NCT02163538|FG000|Participant Flow|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
11196203|NCT02163538|FG001|Participant Flow|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
11196204|NCT02163538|OG000|Outcome|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
11196205|NCT02163538|OG001|Outcome|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
11196206|NCT02163538|EG000|Reported Event|Articulating Enseal|"This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.~articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy."
11196207|NCT02163538|EG001|Reported Event|Ligasure Device|"This group of women undergoing hysterectomy is randomized to the Ligasure energy device.~Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy."
11196208|NCT02163577|BG000|Baseline|Burosumab Q2W|Burosumab SC injections every 2 weeks (Q2W). Dose is determined by the participant's weight and prescribed dose by their study doctor.
11196209|NCT02163577|BG001|Baseline|Burosumab Q4W Then Q2W|Burosumab subcutaneous (SC) injections every 4 weeks (Q4W). Dose is determined by the participant's weight and prescribed dose by their study doctor. Participants in Q4W were to switch to Q2W beginning with Week 64 dosing.
11196210|NCT02163577|BG002|Baseline|Total|Total of all reporting groups
11196211|NCT02163577|FG000|Participant Flow|Burosumab Q2W|Burosumab subcutaneous (SC) injections every 2 weeks (Q2W). Dose was determined by the participant's weight and prescribed dose by their study doctor.
11384073|NCT00304070|EG000|Reported Event|Stratum 3|Stage III OR IV Disease (chemotherapy)
11196212|NCT02163577|FG001|Participant Flow|Burosumab Q4W Then Q2W|Burosumab SC injections every 4 weeks (Q4W). Dose was determined by the participant's weight and prescribed dose by their study doctor. Participants in Q4W were to switch to Q2W beginning with Week 64 dosing.
11196213|NCT02163577|OG000|Outcome|Burosumab Q2W|Burosumab SC injections Q2W. Dose was determined by the participant's weight and prescribed dose by their study doctor.
11196214|NCT02163577|OG001|Outcome|Burosumab Q4W Then Q2W|Burosumab SC injections Q4W. Dose was determined by the participant's weight and prescribed dose by their study doctor. Participants in Q4W were to switch to Q2W beginning with Week 64 dosing.
11196215|NCT02163577|EG000|Reported Event|Burosumab Q2W|Burosumab SC injections Q2W. Dose was determined by the participant's weight and prescribed dose by their study doctor.
11196216|NCT02163577|EG001|Reported Event|Burosumab Q4W Then Q2W|Burosumab SC injections Q4W. Dose was determined by the participant's weight and prescribed dose by their study doctor. Participants in Q4W were to switch to Q2W beginning with Week 64 dosing.
11196217|NCT02163759|BG000|Baseline|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196218|NCT02163759|BG001|Baseline|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11196219|NCT02163759|BG002|Baseline|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196220|NCT02163759|BG003|Baseline|Total|Total of all reporting groups
11196221|NCT02163759|FG000|Participant Flow|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196222|NCT02163759|FG001|Participant Flow|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11196223|NCT02163759|FG002|Participant Flow|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196224|NCT02163759|OG000|Outcome|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196225|NCT02163759|OG001|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196226|NCT02163759|OG000|Outcome|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11196227|NCT02163759|OG001|Outcome|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11202291|NCT02206828|OG004|Outcome|VAS Pain Assessment Month 3|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797336|NCT03367819|OG000|Outcome|mCRPC: Isatuximab + REGN2810|Participants with mCRPC received intravenous (IV) infusion of isatuximab 10 milligrams per kilogram (mg/kg) once weekly (QW) for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
10797337|NCT03367819|OG001|Outcome|NSCLC: Isatuximab + REGN2810|Participants with NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
10797338|NCT03367819|OG000|Outcome|mCRPC + NSCLC : Isatuximab + REGN2810|Participants with mCRPC and NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15 of Cycle 1) and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
10797339|NCT03367819|OG000|Outcome|mCRPC: Isatuximab|Participants with mCRPC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15 of Cycle 1) and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days) (Maximum duration: up to 2 years).
10797340|NCT03367819|OG001|Outcome|NSCLC: Isatuximab|Participants with NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15 of Cycle 1) and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days)) (Maximum duration: up to 2 years).
10797341|NCT03367819|OG000|Outcome|mCRPC: REGN2810|Participants with mCRPC received IV infusion of REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (Maximum duration: up to 2 years).
10797342|NCT03367819|OG001|Outcome|NSCLC: REGN2810|Participants with NSCLC received IV infusion of REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (Maximum duration: up to 2 years).
10797343|NCT03367819|EG000|Reported Event|mCRPC: Isatuximab + REGN2810|Participants with mCRPC received intravenous (IV) infusion of isatuximab 10 milligrams per kilogram (mg/kg) once weekly (QW) for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
10797344|NCT03367819|EG001|Reported Event|NSCLC: Isatuximab + REGN2810|Participants with NSCLC received IV infusion of isatuximab 10 mg/kg QW for 3 weeks (i.e., on Days 1, 8 and 15) of Cycle 1 and then on Day 1 of Cycle 2 and subsequent cycles (each cycle of 21 days), along with REGN2810 350 mg IV infusion on Day 1 of each 21-day treatment Cycle (maximum duration: up to 2 years).
10797345|NCT03182868|BG000|Baseline|Repeatability Group|Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days.
10797346|NCT03182868|BG001|Baseline|Time of Day Group|Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days.
10797347|NCT03182868|BG002|Baseline|Learning Affect Group|Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect.
10797348|NCT03182868|BG003|Baseline|MSQ Group|Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness.
11196228|NCT02163759|OG002|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11196229|NCT02163759|OG000|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11202292|NCT02206828|OG005|Outcome|VAS Pain Assessment 1 Year|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797349|NCT03182868|BG004|Baseline|OKN Only Group|OKN Only Group is for exploratory aims only. Healthy participants will undergo goggle testing limited to Optokinetic Nystagmus (OKN) recordings at two stimulus speeds (20 and 60 deg/s) in both the counterclockwise and clockwise directions.
10797350|NCT03182868|BG005|Baseline|Total|Total of all reporting groups
10797351|NCT03182868|FG000|Participant Flow|Repeatability Group|Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days.
10797352|NCT03182868|FG001|Participant Flow|Time of Day Group|Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days.
10797353|NCT03182868|FG002|Participant Flow|Learning Affect Group|Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect.
10797354|NCT03182868|FG003|Participant Flow|MSQ Group|Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness.
10797355|NCT03182868|FG004|Participant Flow|OKN Only Group|OKN Only Group is for exploratory aims only. Healthy participants will undergo goggle testing limited to Optokinetic Nystagmus (OKN) recordings at two stimulus speeds (20 and 60 deg/s) in both the counterclockwise and clockwise directions.
10797356|NCT03182868|OG000|Outcome|Repeatability Group|Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days.
10797357|NCT03182868|OG001|Outcome|Time of Day Group|Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days.
10797358|NCT03182868|OG002|Outcome|Learning Affect Group|Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect.
10797359|NCT03182868|OG000|Outcome|MSQ Group|Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness.
10797360|NCT03182868|EG000|Reported Event|Repeatability Group|Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days.
10797361|NCT03182868|EG001|Reported Event|Time of Day Group|Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days.
10797362|NCT03182868|EG002|Reported Event|Learning Affect Group|Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect.
10797363|NCT03182868|EG003|Reported Event|MSQ Group|Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness.
10797364|NCT03182868|EG004|Reported Event|OKN Only Group|OKN Only Group is for exploratory aims only. Healthy participants will undergo goggle testing limited to Optokinetic Nystagmus (OKN) recordings at two stimulus speeds (20 and 60 deg/s) in both the counterclockwise and clockwise directions.
10797365|NCT03125902|BG000|Baseline|Placebo and Paclitaxel|Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797366|NCT03125902|BG001|Baseline|Atezolizumab and Paclitaxel|Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797367|NCT03125902|BG002|Baseline|Total|Total of all reporting groups
10797368|NCT03125902|FG000|Participant Flow|Placebo + Paclitaxel|Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797369|NCT03125902|FG001|Participant Flow|Atezolizumab + Paclitaxel|Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797370|NCT03125902|OG000|Outcome|Placebo and Paclitaxel|Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797371|NCT03125902|OG001|Outcome|Atezolizumab and Paclitaxel|Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
11202293|NCT02206828|OG006|Outcome|VAS Pain Assessment 2 Year|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797372|NCT03125902|OG000|Outcome|Atezolizumab and Paclitaxel|Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
11202294|NCT02206828|OG000|Outcome|Quality of Life at 1 Month|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797373|NCT03125902|EG000|Reported Event|Placebo + Paclitaxel|Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797374|NCT03125902|EG001|Reported Event|Atezolizumab + Paclitaxel|Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
10797375|NCT03077620|BG000|Baseline|Poor Sleep Group Control|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797376|NCT03077620|BG001|Baseline|Poor Sleep Group Treatment 1|"10mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797377|NCT03077620|BG002|Baseline|Poor Sleep Group Treatment 2|"20mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797378|NCT03077620|BG003|Baseline|Good Sleep Group|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797379|NCT03077620|BG004|Baseline|Total|Total of all reporting groups
10797380|NCT03077620|FG000|Participant Flow|Poor Sleep Group Control|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797381|NCT03077620|FG001|Participant Flow|Poor Sleep Group Treatment 1|"10mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797382|NCT03077620|FG002|Participant Flow|Poor Sleep Group Treatment 2|"20mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
11196230|NCT02163759|EG000|Reported Event|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
10797383|NCT03077620|FG003|Participant Flow|Good Sleep Group|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797384|NCT03077620|OG000|Outcome|Poor Sleep Group Control|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797385|NCT03077620|OG001|Outcome|Good Sleep Group|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797386|NCT03077620|OG001|Outcome|Poor Sleep Group Treatment 1|"10mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797387|NCT03077620|OG002|Outcome|Poor Sleep Group Treatment 2|"20mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797388|NCT03077620|EG000|Reported Event|Poor Sleep Group Control|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797389|NCT03077620|EG001|Reported Event|Poor Sleep Group Treatment 1|"10mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797390|NCT03077620|EG002|Reported Event|Poor Sleep Group Treatment 2|"20mg Suvorexant tablet h.s. for two consecutive nights~Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit."
10797391|NCT03077620|EG003|Reported Event|Good Sleep Group|"Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.~Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit."
10797392|NCT03027414|BG000|Baseline|Substudy 1 Active and Sham|"HVs that receive active and Sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797393|NCT03027414|BG001|Baseline|Substudy 2 Active and Sham|"HVs that receive active and Sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797394|NCT03027414|BG002|Baseline|Substudy 3 Active and Sham|"HVs will receive offline TMS to the lest IPS (FPN)~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797395|NCT03027414|BG003|Baseline|Total|Total of all reporting groups
10797396|NCT03027414|FG000|Participant Flow|Substudy 1 Active and Sham|"HVs that receive active and sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797397|NCT03027414|FG001|Participant Flow|Substudy 2 Active and Sham|"HVs that receive active and sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797398|NCT03027414|FG002|Participant Flow|Substudy 3 Active and Sham|"HVs will receive offline TMS to the lest IPS (FPN)~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797399|NCT03027414|OG000|Outcome|Substudy 1 Active and Sham|"HVs that receive active and sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797400|NCT03027414|OG001|Outcome|Substudy 3 Active and Sham|"HVs will receive offline TMS to the lest IPS (FPN)~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797401|NCT03027414|OG000|Outcome|Substudy 2|"HVs that receive TMS over the right dlFPC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797402|NCT03027414|EG000|Reported Event|Substudy 1 Active and Sham|"HVs that receive active and Sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797403|NCT03027414|EG001|Reported Event|Substudy 2 Active and Sham|"HVs that receive active and Sham TMS over the right dlPFC~Transcranial Magnetic Stimulation Sham: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797404|NCT03027414|EG002|Reported Event|Substudy 3|"HVs will receive offline TMS to the lest IPS (FPN)~Transcranial Magnetic Stimulation: TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects."
10797405|NCT02951052|BG000|Baseline|CAB LA+RPV LA (Q4W)|During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
10797406|NCT02951052|BG001|Baseline|Current ART|During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
10797407|NCT02951052|BG002|Baseline|Total|Total of all reporting groups
10797408|NCT02951052|FG000|Participant Flow|CAB LA+RPV LA (Q4W)|During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
10797409|NCT02951052|FG001|Participant Flow|Current ART|During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
10797410|NCT02951052|OG000|Outcome|CAB LA+RPV LA (Q4W)|During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
10797411|NCT02951052|OG001|Outcome|Current ART|During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
10797412|NCT02951052|OG000|Outcome|CAB LA|Participants received IM injections of CAB LA 400 mg every four weeks through Week 52.
10797413|NCT02951052|OG000|Outcome|RPV LA|Participants received IM injections of RPV LA 600 mg every four weeks through Week 52.
10797414|NCT02951052|OG000|Outcome|RPV LA|Participants received IM injections of RPV LA 900 mg every four weeks through Week 52.
10797415|NCT02951052|OG001|Outcome|RPV LA|Participants received IM injections of RPV LA 900 mg every four weeks through Week 52.
10797416|NCT02951052|EG000|Reported Event|CAB LA+RPV LA (Q4W)|During Maintenance phase (Day 1-Week 52), participants received oral CAB 30 milligram (mg)+RPV 25 mg once daily from Day 1 for 4 weeks. At Week 4B, the participants were given the last dose of oral CAB+RPV and the first dose of CAB LA 600 mg+RPV LA 900 mg injections within 2 hours of the final oral dose. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg every four weeks (Q4W) through Week 52. After completion of Maintenance phase, participants who chose to enter Extension phase continued to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period
10797417|NCT02951052|EG001|Reported Event|Current ART|During Maintenance phase (Day 1 - Week 52), participants continued to receive current antiretroviral therapy (ART) (protease inhibitor [PI] or integrase inhibitor [INI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus 2 NRTIs for 52 weeks. After completion of the Maintenance phase, participants who chose to enter the Extension phase switched to CAB LA+RPV LA
10797418|NCT02724410|BG000|Baseline|Home Intravenous Ertapenem and PICC|"Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)~Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics."
10797419|NCT02724410|BG001|Baseline|Home Oral Amoxicillin-clavulanate|Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
10797420|NCT02724410|BG002|Baseline|Total|Total of all reporting groups
10797421|NCT02724410|FG000|Participant Flow|Home Intravenous Ertapenem and PICC|"Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)~Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics."
11196231|NCT02163759|EG001|Reported Event|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11196232|NCT02163759|EG002|Reported Event|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
10797422|NCT02724410|FG001|Participant Flow|Home Oral Amoxicillin-clavulanate|Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
10797423|NCT02724410|OG000|Outcome|Home Intravenous Ertapenem and PICC|"Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)~Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics."
10797424|NCT02724410|OG001|Outcome|Home Oral Amoxicillin-clavulanate|Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
10797425|NCT02724410|EG000|Reported Event|Home Intravenous Ertapenem and PICC|"Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)~Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics."
10797426|NCT02724410|EG001|Reported Event|Home Oral Amoxicillin-clavulanate|Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
10797427|NCT02598583|BG000|Baseline|ALXN1210 Cohort 1|Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
10797428|NCT02598583|BG001|Baseline|ALXN1210 Cohort 2|Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
10797429|NCT02598583|BG002|Baseline|Total|Total of all reporting groups
10797430|NCT02598583|FG000|Participant Flow|ALXN1210 Cohort 1|Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
10797431|NCT02598583|FG001|Participant Flow|ALXN1210 Cohort 2|Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
10797432|NCT02598583|OG000|Outcome|ALXN1210 Cohort 1|Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
10797433|NCT02598583|OG001|Outcome|ALXN1210 Cohort 2|Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
10797434|NCT02598583|EG000|Reported Event|ALXN1210 Cohort 1|Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
10797435|NCT02598583|EG001|Reported Event|ALXN1210 Cohort 2|Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
10797436|NCT02550093|BG000|Baseline|All Study Participants|Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of either Oxytocin then Normal Saline or Normal Saline then Oxytocin prior to Thermal Evaluation System Testing.
10797437|NCT02550093|FG000|Participant Flow|Oxytocin, Then Normal Saline|Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 13 days the same subject will then receive a nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 2 (day 14).
10797438|NCT02550093|FG001|Participant Flow|Normal Saline, Then Oxytocin|Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 14 to 15 days the same subject will then receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 2 (day 14).
10797439|NCT02550093|OG000|Outcome|Oxytocin|Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
10797440|NCT02550093|OG001|Outcome|Normal Saline|Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
10797441|NCT02550093|OG000|Outcome|Oxytocin|"Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing.~Oxytocin: Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing."
10797442|NCT02550093|OG001|Outcome|Normal Saline|"Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing.~Normal Saline: Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing."
10797443|NCT02550093|EG000|Reported Event|Oxytocin|Subjects received nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing.
10797444|NCT02550093|EG001|Reported Event|Normal Saline|Subjects received nasal spray(s) into each nostril of Normal Saline prior to Thermal Evaluation System Testing.
10797445|NCT02536794|BG000|Baseline|Treatment (MEDI4736, Tremelimumab)|"Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.~Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tremelimumab: Given IV"
10797446|NCT02536794|FG000|Participant Flow|Treatment (MEDI4736, Tremelimumab)|"Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.~Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tremelimumab: Given IV"
10797447|NCT02536794|OG000|Outcome|Treatment (MEDI4736, Tremelimumab)|"Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.~Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tremelimumab: Given IV"
10797448|NCT02536794|EG000|Reported Event|Treatment (MEDI4736, Tremelimumab)|"Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.~Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Tremelimumab: Given IV"
11202295|NCT02206828|OG001|Outcome|Quality of Life at 1 Year|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797449|NCT02463773|BG000|Baseline|Ultrasound|"Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.~Ultrasound: Diaphragmatic excursion ultrasound assessment"
10797450|NCT02463773|FG000|Participant Flow|Ultrasound|"Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.~Ultrasound: Diaphragmatic excursion ultrasound assessment"
10797451|NCT02463773|OG000|Outcome|Ultrasound|"Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.~Ultrasound: Diaphragmatic excursion ultrasound assessment"
10797452|NCT02463773|EG000|Reported Event|Ultrasound|"Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.~Ultrasound: Diaphragmatic excursion ultrasound assessment"
10797453|NCT02356575|BG000|Baseline|Acupuncture Group|"In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.~Acupuncture"
10797454|NCT02356575|BG001|Baseline|CBT-I Group|"In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.~Cognitive Behavior Therapy"
10797455|NCT02356575|BG002|Baseline|Total|Total of all reporting groups
10797456|NCT02356575|FG000|Participant Flow|Acupuncture Group|"In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.~Acupuncture"
10797457|NCT02356575|FG001|Participant Flow|CBT-I Group|"In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.~Cognitive Behavior Therapy"
11196233|NCT02163811|BG000|Baseline|VETPALS|VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).
10797458|NCT02356575|OG000|Outcome|Acupuncture Group|"In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.~Acupuncture"
10797459|NCT02356575|OG001|Outcome|CBT-I Group|"In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.~Cognitive Behavior Therapy"
10797460|NCT02356575|EG000|Reported Event|Acupuncture Group|"In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.~Acupuncture"
10797461|NCT02356575|EG001|Reported Event|CBT-I Group|"In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.~Cognitive Behavior Therapy"
10797462|NCT02285114|BG000|Baseline|F/TAF+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797463|NCT02285114|BG001|Baseline|F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)|Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
10797464|NCT02285114|BG002|Baseline|F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)|Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797465|NCT02285114|BG003|Baseline|Total|Total of all reporting groups
10797466|NCT02285114|FG000|Participant Flow|F/TAF+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP])
11196234|NCT02163811|BG001|Baseline|Individual Education Support Program|Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care.
11196235|NCT02163811|BG002|Baseline|Total|Total of all reporting groups
11196236|NCT02163811|FG000|Participant Flow|VETPALS|VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).
11196237|NCT02163811|FG001|Participant Flow|Individual Education Support Program|Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care.
10797467|NCT02285114|FG001|Participant Flow|F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)|Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
10797468|NCT02285114|FG002|Participant Flow|F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)|Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797469|NCT02285114|OG000|Outcome|F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV)
10797470|NCT02285114|OG001|Outcome|F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797471|NCT02285114|OG000|Outcome|F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)|Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
10797472|NCT02285114|OG001|Outcome|F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)|Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797473|NCT02285114|OG000|Outcome|F/TAF+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797474|NCT02285114|OG001|Outcome|F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)|Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
10797475|NCT02285114|OG002|Outcome|F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)|Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
11202296|NCT02206828|OG002|Outcome|Quality of Life at 2 Year|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797476|NCT02285114|OG001|Outcome|F/TAF 200/25 mg +3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797477|NCT02285114|OG000|Outcome|F/TAF+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks.After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797478|NCT02285114|EG000|Reported Event|F/TAF+3rd ARV Agent (Cohort 1)|Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797479|NCT02285114|EG001|Reported Event|F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)|Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV)
10797480|NCT02285114|EG002|Reported Event|F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)|Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP)
10797481|NCT02263508|BG000|Baseline|Phase 1b: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ plaque-forming units (PFU)/mL by intralesional injection on day 1 of week 1. Subsequent doses of talimogene laherparepvec at up to 4 mL of 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until disappearance of injectable lesions, complete response (CR), confirmed disease progression (PD) per modified Immune-related Response Criteria (irRC), intolerance of study treatment, 24 months from the date of the first dose of pembrolizumab, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 2 weeks starting at the time of the third dose of talimogene laherparepvec (week 6) until confirmed PD per modified irRC, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797482|NCT02263508|BG001|Baseline|Phase 3: Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797483|NCT02263508|BG002|Baseline|Phase 3: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ PFU/mL by intralesional injection on day 1. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection of talimogene laherparepvec (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, iCR, confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797484|NCT02263508|BG003|Baseline|Total|Total of all reporting groups
11196238|NCT02163811|OG000|Outcome|VETPALS|VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).
10797485|NCT02263508|FG000|Participant Flow|Phase 1b: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ plaque-forming units (PFU)/mL by intralesional injection on day 1 of week 1. Subsequent doses of talimogene laherparepvec at up to 4 mL of 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until disappearance of injectable lesions, complete response (CR), confirmed disease progression (PD) per modified Immune-related Response Criteria (irRC), intolerance of study treatment, 24 months from the date of the first dose of pembrolizumab, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 2 weeks starting at the time of the third dose of talimogene laherparepvec (week 6) until confirmed PD per modified irRC, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797486|NCT02263508|FG001|Participant Flow|Phase 3: Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797487|NCT02263508|FG002|Participant Flow|Phase 3: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ PFU/mL by intralesional injection on day 1. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection of talimogene laherparepvec (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, iCR, confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797488|NCT02263508|OG000|Outcome|Phase 1b: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ plaque-forming units (PFU)/mL by intralesional injection on day 1 of week 1. Subsequent doses of talimogene laherparepvec at up to 4 mL of 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until disappearance of injectable lesions, complete response (CR), confirmed disease progression (PD) per modified Immune-related Response Criteria (irRC), intolerance of study treatment, 24 months from the date of the first dose of pembrolizumab, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 2 weeks starting at the time of the third dose of talimogene laherparepvec (week 6) until confirmed PD per modified irRC, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797489|NCT02263508|OG000|Outcome|Phase 3: Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797490|NCT02263508|OG001|Outcome|Phase 3: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ PFU/mL by intralesional injection on day 1. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection of talimogene laherparepvec (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, iCR, confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
11196239|NCT02163811|OG001|Outcome|Individual Education Support Program|Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care.
11196240|NCT02163811|EG000|Reported Event|VETPALS|VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).
11196241|NCT02163811|EG001|Reported Event|Individual Education Support Program|Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care.
10797491|NCT02263508|OG000|Outcome|Phase 3 : Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797492|NCT02263508|OG001|Outcome|Phase 3: Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797493|NCT02263508|OG002|Outcome|Phase 3: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ PFU/mL by intralesional injection on day 1. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection of talimogene laherparepvec (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, iCR, confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797494|NCT02263508|EG000|Reported Event|Phase 1b: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ plaque-forming units (PFU)/mL by intralesional injection on day 1 of week 1. Subsequent doses of talimogene laherparepvec at up to 4 mL of 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until disappearance of injectable lesions, complete response (CR), confirmed disease progression (PD) per modified Immune-related Response Criteria (irRC), intolerance of study treatment, 24 months from the date of the first dose of pembrolizumab, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 2 weeks starting at the time of the third dose of talimogene laherparepvec (week 6) until confirmed PD per modified irRC, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797495|NCT02263508|EG001|Reported Event|Phase 3: Placebo + Pembrolizumab|Participants received up to 4 mL placebo to talimogene laherparepvec by intralesional injection on day 1 of week 0. Subsequent doses of placebo (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, complete response per modified Immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) (iCR), confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of placebo, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797496|NCT02263508|EG002|Reported Event|Phase 3: Talimogene Laherparepvec + Pembrolizumab|Participants received talimogene laherparepvec at an initial dose of up to 4 mL 10⁶ PFU/mL by intralesional injection on day 1. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL (up to 4 mL) began 3 weeks after the first dose and were administered every 2 weeks until the fifth injection of talimogene laherparepvec (week 9), and then synchronously with pembrolizumab thereafter every 3 weeks until disappearance of injectable lesions, iCR, confirmed iPD per modified irRC-RECIST, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first. Participants also received 200 mg pembrolizumab administered intravenously every 3 weeks starting on day 1 of week 0, until confirmed iPD per modified irRC-RECIST, treatment intolerance, 24 months from the first dose, or end of study, whichever occurred first.
10797497|NCT02246530|BG000|Baseline|PRP Injection Into PTRCT|"Treatment - PRP injection~PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.~PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug."
10797498|NCT02246530|BG001|Baseline|Subacromial Steroid Bursal Injection|"Current standard of care for treatment of resistant partial thickness rotator cuff tears~Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound"
10797499|NCT02246530|BG002|Baseline|Total|Total of all reporting groups
11196242|NCT02163824|BG000|Baseline|KPI-121 0.25% QID|"KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11202297|NCT02206828|OG000|Outcome|Patient Satisfaction At 1 Year|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797500|NCT02246530|FG000|Participant Flow|PRP Injection Into PTRCT|"Treatment - PRP injection~PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.~PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug."
10797501|NCT02246530|FG001|Participant Flow|Subacromial Steroid Bursal Injection|"Current standard of care for treatment of resistant partial thickness rotator cuff tears~Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound"
10797502|NCT02246530|OG000|Outcome|PRP Injection Into PTRCT|"Treatment - PRP injection~PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.~PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug."
10797503|NCT02246530|OG001|Outcome|Subacromial Steroid Bursal Injection|"Current standard of care for treatment of resistant partial thickness rotator cuff tears~Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound"
10797504|NCT02246530|EG000|Reported Event|PRP Injection Into PTRCT|"Treatment - PRP injection~PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.~PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug."
10797505|NCT02246530|EG001|Reported Event|Subacromial Steroid Bursal Injection|"Current standard of care for treatment of resistant partial thickness rotator cuff tears~Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound"
10797506|NCT02002819|BG000|Baseline|Levetiracetam-Placebo|"This group receives levetiracetam for 4 weeks twice daily, then has a break where no treatment is given for 4 weeks, and then receives placebo for 4 weeks.~levetiracetam"
10797507|NCT02002819|BG001|Baseline|Placebo-Levetiracetam|"This group receives placebo for 4 weeks twice daily, then has a break where no treatment is given for 4 weeks, and then receives levetiracetam for 4 weeks.~levetiracetam"
10797508|NCT02002819|BG002|Baseline|Total|Total of all reporting groups
10797509|NCT02002819|FG000|Participant Flow|Levetiracetam-Placebo|"This group receives levetiracetam for 4 weeks twice daily, then has a break where no treatment is given for 4 weeks, and then receives placebo for 4 weeks.~levetiracetam"
10797510|NCT02002819|FG001|Participant Flow|Placebo-Levetiracetam|"This group receives placebo for 4 weeks twice daily, then has a break where no treatment is given for 4 weeks, and then receives levetiracetam for 4 weeks.~levetiracetam"
10797511|NCT02002819|OG000|Outcome|Levetiracetam|Those taking the test during their Levetiracetam treatment phase, whether it be before or after the crossover.
10797512|NCT02002819|OG001|Outcome|Placebo|THose receiving placebo treatment, whether before or after the crossover.
10797513|NCT02002819|OG001|Outcome|Placebo|Those taking the test during their placebo treatment phase, whether before or after the crossover.
10797514|NCT02002819|OG000|Outcome|Levetiracetam|Those doing the interview during their Levetiracetam treatment phase, whether it be before or after the crossover.
10797515|NCT02002819|OG001|Outcome|Placebo|Those doing the interview during their placebo treatment phase, whether before or after the crossover.
10797516|NCT02002819|OG000|Outcome|Levetiracetam|Activity measured during their Levetiracetam treatment phase, whether it be before or after the crossover.
10797517|NCT02002819|OG001|Outcome|Placebo|Activity during their placebo treatment phase, whether before or after the crossover.
10797518|NCT02002819|OG000|Outcome|Levetiracetam (Epileptiform Activity)|Those with epileptiform activity taking the test during their Levetiracetam treatment phase, whether it be before or after the crossover.o.
10797519|NCT02002819|OG001|Outcome|Placebo (Epileptiform Activity)|Those with epileptiform activity taking the test during their placebo treatment phase, whether before or after the crossover.
10797520|NCT02002819|OG000|Outcome|Levetiracetam (Epileptiform Activity)|Those with epileptiform activity taking the test during their Levetiracetam treatment phase, whether it be before or after the crossover.
10797521|NCT02002819|OG000|Outcome|No Epileptiform Activity|Those who did the task without any sign of epileptiform activity.
10797522|NCT02002819|OG001|Outcome|Epileptic Activity|Those who did the task who displayed epileptic activity
10797523|NCT02002819|OG000|Outcome|Levetiracetam|Those doing the assessment during their Levetiracetam treatment phase, whether it be before or after the crossover.
10797524|NCT02002819|OG001|Outcome|Placebo|Those doing the activity during their placebo treatment phase, whether before or after the crossover.
10797525|NCT02002819|OG000|Outcome|Levetiracetam|Those who were on Leviteracetam treatment.
10797526|NCT02002819|OG001|Outcome|Placebo|THose on placebo treatment.
10797527|NCT02002819|OG000|Outcome|No Epileptiform Activity|Those who took the test but displayed no evidence of epileptiform activity.
10797528|NCT02002819|OG001|Outcome|Epileptiform Activity|THose who took the test and show evidence of epileptiform activity.
10797529|NCT02002819|EG000|Reported Event|Levetiracetam|Adverse events occurring when participants were taking Levetiracetam.
10797530|NCT02002819|EG001|Reported Event|Placebo|Adverse events occurring when participants were taking Placebo.
10797531|NCT01936857|BG000|Baseline|Buprenorphine/Naloxone|"Office based treatment of opioid dependence with buprenorphine/naloxone~Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician."
10797532|NCT01936857|BG001|Baseline|Methadone Maintenance Therapy|"Referral to methadone maintenance therapy for treatment of opioid dependence.~Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT."
10797533|NCT01936857|BG002|Baseline|Total|Total of all reporting groups
10797534|NCT01936857|FG000|Participant Flow|Buprenorphine/Naloxone|"Office based treatment of opioid dependence with buprenorphine/naloxone~Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician."
10797535|NCT01936857|FG001|Participant Flow|Methadone Maintenance Therapy|"Referral to methadone maintenance therapy for treatment of opioid dependence.~Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT."
10797536|NCT01936857|OG000|Outcome|Buprenorphine/Naloxone|"Office based treatment of opioid dependence with buprenorphine/naloxone~Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician."
10797537|NCT01936857|OG001|Outcome|Methadone Maintenance Therapy|"Referral to methadone maintenance therapy for treatment of opioid dependence.~Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT."
10797538|NCT01936857|EG000|Reported Event|Buprenorphine/Naloxone|"Office based treatment of opioid dependence with buprenorphine/naloxone~Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician."
10797539|NCT01936857|EG001|Reported Event|Methadone Maintenance Therapy|"Referral to methadone maintenance therapy for treatment of opioid dependence.~Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT."
10797540|NCT01865539|BG000|Baseline|Custom Foot Orthotic|"Custom foot orthotic~Custom Foot Orthotic: Custom foot orthotic with custom design pads"
10797541|NCT01865539|BG001|Baseline|Sham Orthotic|"Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.~Sham Orthotic: Leather insert without the custom design pads"
10797542|NCT01865539|BG002|Baseline|Total|Total of all reporting groups
10797543|NCT01865539|FG000|Participant Flow|Custom Foot Orthotic|"Custom foot orthotic~Custom Foot Orthotic: Custom foot orthotic with custom design pads"
10797544|NCT01865539|FG001|Participant Flow|Sham Orthotic|"Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.~Sham Orthotic: Leather insert without the custom design pads"
10797545|NCT01865539|OG000|Outcome|Custom Foot Orthotic|"Custom foot orthotic~Custom Foot Orthotic: Custom foot orthotic with custom design pads"
10797546|NCT01865539|OG001|Outcome|Sham Orthotic|"Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.~Sham Orthotic: Leather insert without the custom design pads"
10797547|NCT01865539|EG000|Reported Event|Custom Foot Orthotic|"Custom foot orthotic~Custom Foot Orthotic: Custom foot orthotic with custom design pads"
10797548|NCT01865539|EG001|Reported Event|Sham Orthotic|"Sham Orthotic~Sham Orthotic: Leather insert without the custom design pads"
10797558|NCT01715285|BG000|Baseline|Abiraterone Acetate+Prednisone+ADT|Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
10797559|NCT01715285|BG001|Baseline|Placebo + ADT|Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
10797560|NCT01715285|BG002|Baseline|Total|Total of all reporting groups
10797561|NCT01715285|FG000|Participant Flow|Abiraterone Acetate+Prednisone+ADT|Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
10797562|NCT01715285|FG001|Participant Flow|Placebo + ADT|Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
10797563|NCT01715285|FG002|Participant Flow|Placebo to Abiraterone Acetate + Prednisone|Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate + Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
10797564|NCT01715285|OG000|Outcome|Abiraterone Acetate+Prednisone+ADT|Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
10797565|NCT01715285|OG001|Outcome|Placebo + ADT|Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
10797566|NCT01715285|EG000|Reported Event|Treatment Period: Abiraterone Acetate+Prednisone+ADT|Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
10797567|NCT01715285|EG001|Reported Event|Treatment Period: Placebo + ADT|Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
10797568|NCT01715285|EG002|Reported Event|OL Extension Phase: Placebo to Abiraterone Acetate+Prednisone|Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate + Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
10797569|NCT01613118|BG000|Baseline|RE-021 (Sparsentan) 200 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797570|NCT01613118|BG001|Baseline|RE-021 (Sparsentan) 400 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797571|NCT01613118|BG002|Baseline|RE-021 (Sparsentan) 800 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797572|NCT01613118|BG003|Baseline|Irbesartan 300 mg|"The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks.~Patients at </= 50kg will receive 150mg irbesartan for the 8 week duration.~Irbesartan: Oral, once-daily"
10797573|NCT01613118|BG004|Baseline|Total|Total of all reporting groups
10797574|NCT01613118|FG000|Participant Flow|RE-021 (Sparsentan) 200 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797575|NCT01613118|FG001|Participant Flow|RE-021 (Sparsentan) 400 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
11202298|NCT02206828|OG001|Outcome|Patient Satisfaction At 2 Year|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797576|NCT01613118|FG002|Participant Flow|RE-021 (Sparsentan) 800 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797577|NCT01613118|FG003|Participant Flow|Irbesartan 300 mg|"The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks.~Patients at </= 50kg will receive 150mg irbesartan for the 8 week duration.~Irbesartan: Oral, once-daily"
10797578|NCT01613118|OG000|Outcome|RE-021 (Sparsentan) 200, 400, 800 mg Pooled|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200, 400, or 800mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797579|NCT01613118|OG001|Outcome|Irbesartan 300 mg Pooled|"The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks.~Patients at </= 50kg will receive 150mg irbesartan for the 8 week duration.~Irbesartan: Oral, once-daily"
10797580|NCT01613118|OG002|Outcome|RE-021 (Sparsentan) 200mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose will be 200mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797581|NCT01613118|OG003|Outcome|RE-021 (Sparsentan) 400mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose will be 400mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797582|NCT01613118|OG004|Outcome|RE-021 (Sparsentan) 800mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose will be 800mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797583|NCT01613118|EG000|Reported Event|RE-021 (Sparsentan) 200 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797584|NCT01613118|EG001|Reported Event|RE-021 (Sparsentan) 400 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg.~Patients at </= 50kg will receive half the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797585|NCT01613118|EG002|Reported Event|RE-021 (Sparsentan) 800 mg|"RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg.~Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.~RE-021 (Sparsentan): Oral, once-daily"
10797586|NCT01613118|EG003|Reported Event|Irbesartan 300 mg|"The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks.~Patients at </= 50kg will receive 150mg irbesartan for the 8 week duration.~Irbesartan: Oral, once-daily"
11202299|NCT02206828|OG000|Outcome|Ease of Use - Mesh Flexibility|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202300|NCT02206828|OG001|Outcome|Ease of Use - Mesh Easy to Trim|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797587|NCT04585776|BG000|Baseline|LY900014 + Insulin Degludec|LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
10797588|NCT04585776|FG000|Participant Flow|LY900014 + Insulin Degludec|LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
10797589|NCT04585776|OG000|Outcome|LY900014 + Insulin Degludec|LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
10797590|NCT04585776|EG000|Reported Event|LY900014 + Insulin Degludec|LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
10797591|NCT04209725|BG000|Baseline|CPX-351 and Quizartinib Treatment|Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. CPX-351: To be given during the induction and consolidation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase. Quizartinib: To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
10797592|NCT04209725|FG000|Participant Flow|CPX-351 and Quizartinib Treatment|Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. CPX-351: To be given during the induction and consolidation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase. Quizartinib: To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
10797593|NCT04209725|OG000|Outcome|CPX-351 and Quizartinib Treatment|Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. CPX-351: To be given during the induction and consolidation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase. Quizartinib: To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
10797594|NCT04209725|EG000|Reported Event|CPX-351 and Quizartinib Treatment|Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. CPX-351: To be given during the induction and consolidation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase. Quizartinib: To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
10797595|NCT04185909|BG000|Baseline|Full-face Renuvion Dermal System Treatment|Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
10797596|NCT04185909|FG000|Participant Flow|Full-face Renuvion Dermal System Treatment|Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
10797597|NCT04185909|OG000|Outcome|Full-face Renuvion Dermal System Treatment|Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
10797598|NCT04185909|EG000|Reported Event|Full-face Renuvion Dermal System Treatment|Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
10797599|NCT04076943|BG000|Baseline|Roxadustat|Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
10797600|NCT04076943|FG000|Participant Flow|Roxadustat|Participants received roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 milligrams (mg)/kilogram (kg). The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved hemoglobin (Hb) response.
10797601|NCT04076943|OG000|Outcome|Roxadustat|Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
10797602|NCT04076943|EG000|Reported Event|Roxadustat|Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
10797603|NCT03982043|BG000|Baseline|Text2Connect|"Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.~Text2Connect: Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services."
10797604|NCT03982043|BG001|Baseline|Treatment As Usual (TAU)|Participants in the TAU group received a referral for mental health services from their Primary Care Physician (PCP) and did not receive the personalized text messaging intervention.
10797605|NCT03982043|BG002|Baseline|Total|Total of all reporting groups
10797606|NCT03982043|FG000|Participant Flow|Text2Connect|"Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.~Text2Connect: Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services."
10797607|NCT03982043|FG001|Participant Flow|Treatment As Usual (TAU)|Participants in the TAU group received a referral for mental health services from their Primary Care Physician (PCP) and did not receive the personalized text messaging intervention.
10797608|NCT03982043|OG000|Outcome|Text2Connect|"Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.~Text2Connect: Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services."
10797609|NCT03982043|OG001|Outcome|Treatment as Usual (TAU)|Participants in the treatment as usual (TAU) group received a referral for mental health services from their Primary Care Physician (PCP). Participants in this group did not receive the personalized text messaging intervention, Text2Connect.
10797610|NCT03982043|OG001|Outcome|Treatment As Usual (TAU)|Participants in the treatment as usual (TAU) group received a referral for mental health services from their Primary Care Physician (PCP). Participants in this group did not receive the personalized text messaging intervention, Text2Connect.
11196243|NCT02163824|BG001|Baseline|KPI-121 1.0% BID|"KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
10797611|NCT03982043|EG000|Reported Event|Text2Connect|"Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.~Text2Connect: Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services."
10797612|NCT03982043|EG001|Reported Event|Treatment As Usual (TAU)|Participants in the TAU group received a referral for mental health services from their Primary Care Physician (PCP) and did not receive the personalized text messaging intervention.
10797613|NCT03905694|BG000|Baseline|Lumasiran|"Participants weighing <10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Participants in maintenance dosing who transitioned from <10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for participants weighing ≥10 kg. Thereafter, participants followed every-3-months dosing until the end of the study.~Participants weighing ≥10 to <20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants with weight increases crossing the threshold for the next weight-based dosing category (<10 kg to ≥10 kg or <20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached."
10797614|NCT03905694|FG000|Participant Flow|Lumasiran|"Participants weighing <10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Participants in maintenance dosing who transitioned from <10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for participants weighing ≥10 kg. Thereafter, participants followed every-3-months dosing until the end of the study.~Participants weighing ≥10 to <20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants with weight increases crossing the threshold for the next weight-based dosing category (<10 kg to ≥10 kg or <20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached."
10797615|NCT03905694|OG000|Outcome|Lumasiran|"Participants weighing <10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Participants in maintenance dosing who transitioned from <10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for participants weighing ≥10 kg. Thereafter, participants followed every-3-months dosing until the end of the study.~Participants weighing ≥10 to <20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants with weight increases crossing the threshold for the next weight-based dosing category (<10 kg to ≥10 kg or <20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached."
10797616|NCT03905694|EG000|Reported Event|Lumasiran|"Participants weighing <10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Participants in maintenance dosing who transitioned from <10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for participants weighing ≥10 kg. Thereafter, participants followed every-3-months dosing until the end of the study.~Participants weighing ≥10 to <20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period.~Participants with weight increases crossing the threshold for the next weight-based dosing category (<10 kg to ≥10 kg or <20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached."
11196244|NCT02163824|BG002|Baseline|Vehicle of KPI-121|"Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11196245|NCT02163824|BG003|Baseline|Total|Total of all reporting groups
11196246|NCT02163824|FG000|Participant Flow|KPI-121 0.25% QID|"KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196247|NCT02163824|FG001|Participant Flow|KPI-121 1.0% BID|"KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196248|NCT02163824|FG002|Participant Flow|Vehicle of KPI-121|"Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11196249|NCT02163824|OG000|Outcome|KPI-121 0.25% QID|"KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196250|NCT02163824|OG001|Outcome|KPI-121 1.0% BID|"KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196251|NCT02163824|OG002|Outcome|Vehicle of KPI-121|"Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
10797617|NCT03332498|BG000|Baseline|Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
10797618|NCT03332498|BG001|Baseline|Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
10797619|NCT03332498|BG002|Baseline|Phase 2: Treatment at RP2D|"Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib~Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.~Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies."
10797620|NCT03332498|BG003|Baseline|Total|Total of all reporting groups
11196252|NCT02163824|EG000|Reported Event|KPI-121 0.25% QID|"KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 0.25%: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196253|NCT02163824|EG001|Reported Event|KPI-121 1.0% BID|"KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11196254|NCT02163824|EG002|Reported Event|Vehicle of KPI-121|"Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.~Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11196255|NCT02163837|BG000|Baseline|Rifaximine|rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires
11196256|NCT02163837|FG000|Participant Flow|Rifaximine|rifaximine was given to all included patients after one week of assesment of sleep disturbances by polysomnography, actigraphy and questionnaires
11196257|NCT02163837|OG000|Outcome|Rifaximine|rifaximine
11196258|NCT02163837|EG000|Reported Event|Rifaximine|rifaximine
11196259|NCT02163902|BG000|Baseline|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
11196260|NCT02163902|BG001|Baseline|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
11196261|NCT02163902|BG002|Baseline|Total|Total of all reporting groups
11196262|NCT02163902|FG000|Participant Flow|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
11196263|NCT02163902|FG001|Participant Flow|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
10797621|NCT03332498|FG000|Participant Flow|Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
10797622|NCT03332498|FG001|Participant Flow|Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
10797623|NCT03332498|FG002|Participant Flow|Phase 2: Treatment at RP2D|"Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib~Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.~Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies."
10797624|NCT03332498|OG000|Outcome|Pembrolizumab and Ibrutinib|"Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W).~Ibrutinib by mouth (PO): Phase I Dose Escalation at doses of 420 mg daily (cohort 0) and 560 mg daily (cohort 1)~Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.~Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies."
10797625|NCT03332498|OG000|Outcome|Phase 2: Treatment at RP2D|"Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib~Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.~Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies."
10797626|NCT03332498|EG000|Reported Event|Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
10797627|NCT03332498|EG001|Reported Event|Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)|Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
10797628|NCT03332498|EG002|Reported Event|Phase 2: Treatment at RP2D|"Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib~Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.~Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies."
10797629|NCT03122301|BG000|Baseline|Bupivicaine|"Stellate Ganglion Block Injection with bupivicaine~Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card."
10797630|NCT03122301|BG001|Baseline|Saline|"Saline injection~Saline: sham injection with saline"
10797631|NCT03122301|BG002|Baseline|Total|Total of all reporting groups
10797632|NCT03122301|FG000|Participant Flow|Bupivicaine|"Stellate Ganglion Block Injection with bupivicaine~Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card."
10797633|NCT03122301|FG001|Participant Flow|Saline|"Saline injection~Saline: sham injection with saline"
10797634|NCT03122301|OG000|Outcome|Bupivicaine|"Stellate Ganglion Block Injection with bupivicaine~Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card."
10797635|NCT03122301|OG001|Outcome|Saline|"Saline injection~Saline: sham injection with saline"
10797636|NCT03122301|EG000|Reported Event|Bupivicaine|"Stellate Ganglion Block Injection with bupivicaine~Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card."
10797637|NCT03122301|EG001|Reported Event|Saline|"Saline injection~Saline: sham injection with saline"
10797638|NCT02900976|BG000|Baseline|Arm I (RTX)|"Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.~Rituximab: Given IV"
10797639|NCT02900976|BG001|Baseline|Arm II (LMP-TC)|"Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.~Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV~Rituximab: Given IV"
10797640|NCT02900976|BG002|Baseline|Total|Total of all reporting groups
10797641|NCT02900976|FG000|Participant Flow|Arm I (RTX)|"Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.~Rituximab: Given IV"
11196264|NCT02163902|OG000|Outcome|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
10797642|NCT02900976|FG001|Participant Flow|Arm II (LMP-TC)|"Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.~Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV~Rituximab: Given IV"
10797643|NCT02900976|OG000|Outcome|Arm II (LMP-TC)|"Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.~Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV~Rituximab: Given IV"
10797644|NCT02900976|EG000|Reported Event|Arm I (RTX) Induction|Patients receive rituximab or biosimilar intravenously (IV) on days 1, 8, 15. Cycle continues for up to 21 days in the absence of disease progression or unacceptable toxicity.
10797645|NCT02900976|EG001|Reported Event|Arm II (LMP-TC) Induction|Patients receive rituximab or biosimilar intravenously (IV) on days 1, 8, 15. Cycle continues for up to 21 days in the absence of disease progression or unacceptable toxicity.
10797646|NCT02900976|EG002|Reported Event|Arm I (RTX)|"Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.~Rituximab: Given IV"
10797647|NCT02900976|EG003|Reported Event|Arm II (LMP-TC)|"Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.~Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV~Rituximab: Given IV"
10797648|NCT02807350|BG000|Baseline|Overminus Treatment|"spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere~Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere"
10797649|NCT02807350|BG001|Baseline|Non-overminus Treatment|"spectacles with full cycloplegic refraction without overminus~Non-overminus treatment: spectacles with full cycloplegic refraction without overminus"
10797650|NCT02807350|BG002|Baseline|Total|Total of all reporting groups
10797651|NCT02807350|FG000|Participant Flow|Overminus Treatment|"spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere~Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere"
10797652|NCT02807350|FG001|Participant Flow|Non-overminus Treatment|"spectacles with full cycloplegic refraction without overminus~Non-overminus treatment: spectacles with full cycloplegic refraction without overminus"
10797653|NCT02807350|OG000|Outcome|Overminus Treatment|"spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere~Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere"
10797654|NCT02807350|OG001|Outcome|Non-overminus Treatment|"spectacles with full cycloplegic refraction without overminus~Non-overminus treatment: spectacles with full cycloplegic refraction without overminus"
10797655|NCT02807350|EG000|Reported Event|Overminus Treatment|"spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere~Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere"
10797656|NCT02807350|EG001|Reported Event|Non-overminus Treatment|"spectacles with full cycloplegic refraction without overminus~Non-overminus treatment: spectacles with full cycloplegic refraction without overminus"
10797657|NCT02720185|BG000|Baseline|Dasatinib 100mg|"Dasatinib 100mg for 7-10 days until day prior to surgery~Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)~Conventional Surgery: Undergo surgery~Laboratory Biomarker Analysis: Correlative studies"
10797658|NCT02720185|FG000|Participant Flow|Dasatinib 100mg|"Dasatinib 100mg for 7-10 days until day prior to surgery~Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)~Conventional Surgery: Undergo surgery~Laboratory Biomarker Analysis: Correlative studies"
10797659|NCT02720185|OG000|Outcome|Dasatinib 100mg|"Dasatinib 100mg for 7-10 days until day prior to surgery~Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)~Conventional Surgery: Undergo surgery~Laboratory Biomarker Analysis: Correlative studies"
10797660|NCT02720185|EG000|Reported Event|Dasatinib 100mg|"Dasatinib 100mg for 7-10 days until day prior to surgery~Dasatinib: 100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)~Conventional Surgery: Undergo surgery~Laboratory Biomarker Analysis: Correlative studies"
10797661|NCT02710669|BG000|Baseline|(R)-Propafenone|"Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes~(R)-propafenone"
10797662|NCT02710669|BG001|Baseline|(S)-Propafenone|"Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes~(S)-Propafenone"
10797663|NCT02710669|BG002|Baseline|Placebo|"Placebo (normal saline) is infused over 10 minutes~Placebo"
10797664|NCT02710669|BG003|Baseline|Total|Total of all reporting groups
10797665|NCT02710669|FG000|Participant Flow|(R)-Propafenone|"Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes~(R)-propafenone"
10797666|NCT02710669|FG001|Participant Flow|(S)-Propafenone|"Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes~(S)-Propafenone"
10797667|NCT02710669|FG002|Participant Flow|Placebo|"Placebo (normal saline) is infused over 10 minutes~Placebo"
10797668|NCT02710669|OG000|Outcome|(R)-Propafenone|"Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes~(R)-propafenone"
10797669|NCT02710669|OG001|Outcome|(S)-Propafenone|"Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes~(S)-Propafenone"
10797670|NCT02710669|OG002|Outcome|Placebo|"Placebo (normal saline) is infused over 10 minutes~Placebo"
10797671|NCT02710669|EG000|Reported Event|(R)-Propafenone|"Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes~(R)-propafenone"
10797672|NCT02710669|EG001|Reported Event|(S)-Propafenone|"Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes~(S)-Propafenone"
10797673|NCT02710669|EG002|Reported Event|Placebo|"Placebo (normal saline) is infused over 10 minutes~Placebo"
10797674|NCT02684461|BG000|Baseline|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797675|NCT02684461|BG001|Baseline|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797676|NCT02684461|BG002|Baseline|Arm C: Concurrent Consolidation|"Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797677|NCT02684461|BG003|Baseline|Total|Total of all reporting groups
10797678|NCT02684461|FG000|Participant Flow|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797679|NCT02684461|FG001|Participant Flow|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797680|NCT02684461|FG002|Participant Flow|Arm C: Concurrent Consolidation|"Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797681|NCT02684461|OG000|Outcome|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797682|NCT02684461|OG001|Outcome|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797683|NCT02684461|OG002|Outcome|Arm C: Concurrent Consolidation|"Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797684|NCT02684461|OG000|Outcome|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles"
10797685|NCT02684461|OG000|Outcome|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797686|NCT02684461|OG001|Outcome|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21 Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797687|NCT02684461|OG002|Outcome|Arm C: Concurrent Consolidation|"Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797688|NCT02684461|OG000|Outcome|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles."
10797689|NCT02684461|OG001|Outcome|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles."
10797690|NCT02684461|EG000|Reported Event|Arm A: Sequential Consolidation|"Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797691|NCT02684461|EG001|Reported Event|Arm B: Sequential Consolidation|"Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797692|NCT02684461|EG002|Reported Event|Arm C: Concurrent Consolidation|"Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles~Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
10797693|NCT02657343|BG000|Baseline|Cohort A: Ribociclib + T-DM1 [Dose 1: 300mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 300 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797694|NCT02657343|BG001|Baseline|Cohort A: Ribociclib + T-DM1 [Dose 2: 400mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 400 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797695|NCT02657343|BG002|Baseline|Cohort A: Ribociclib + T-DM1 [Dose 3: 500mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 500 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797696|NCT02657343|BG003|Baseline|Cohort A: Ribociclib + T-DM1 [Dose 4: 600mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 600 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797697|NCT02657343|BG004|Baseline|Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study]|"Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment.~Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks."
10797698|NCT02657343|BG005|Baseline|Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study]|"Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle).~Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care."
10797699|NCT02657343|BG006|Baseline|Total|Total of all reporting groups
10797700|NCT02657343|FG000|Participant Flow|Cohort A: Ribociclib + T-DM1Cohort A: Ribociclib + T-DM1 [Dose 1: 300mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 300 mg (n = 3) Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797701|NCT02657343|FG001|Participant Flow|Cohort A: Ribociclib + T-DM1Cohort A: Ribociclib + T-DM1 [Dose 2: 400mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 400 mg (n = 3) Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797702|NCT02657343|FG002|Participant Flow|Cohort A: Ribociclib + T-DM1Cohort A: Ribociclib + T-DM1 [Dose: 500 mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 500 mg (n = 3) Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797703|NCT02657343|FG003|Participant Flow|Cohort A: Ribociclib + T-DM1Cohort A: Ribociclib + T-DM1 [Dose: 600mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 600 mg (n = 3) Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797704|NCT02657343|FG004|Participant Flow|Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study]|"Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment.~Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks."
10797705|NCT02657343|FG005|Participant Flow|Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study]|"Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle).~Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care."
10797706|NCT02657343|OG000|Outcome|Cohort A: Ribociclib + T-DM1|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 300 mg (n = 3), 400 mg (n = 3), 500 mg (n = 3), and 600 mg (n = 3).~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797707|NCT02657343|OG000|Outcome|Cohort B: Ribociclib + Trastuzumab|Ribociclib will be given orally once day continuously for a 21-day cycle of treatment (except at Dose Level -2, when Ribociclib is given Days 1-14 of a 21 day cycle). Trastuzumab will be given as IV infusions over a pre-determined period of time and dose.
10797708|NCT02657343|OG000|Outcome|Cohort C: Ribociclib + Trastuzumab + Fulvestrant|"Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle).~Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care."
10797709|NCT02657343|OG000|Outcome|Cohort A: Ribociclib + T-DM1|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 300 mg (n = 3), 400 mg (n = 3), 500 mg (n = 3), and 600 mg (n = 3).~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797710|NCT02657343|OG000|Outcome|Cohort B: Ribociclib + Trastuzumab|"Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment (except at Dose Level -2, when Ribociclib is given Days 1-14 of a 21 day cycle).~Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks."
10797711|NCT02657343|OG000|Outcome|Cohort C: Ribociclib + Trastuzumab + Fulvestrant|Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle). Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care.
10797712|NCT02657343|EG000|Reported Event|Cohort A: Ribociclib + T-DM1 [Dose 1: 300mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 300 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797713|NCT02657343|EG001|Reported Event|Cohort A: Ribociclib + T-DM1 [Dose 2: 400mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 400 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797714|NCT02657343|EG002|Reported Event|Cohort A: Ribociclib + T-DM1 [Dose 3: 500mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 500 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797715|NCT02657343|EG003|Reported Event|Cohort A: Ribociclib + T-DM1 [Dose 4: 600mg]|"Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of 600 mg (n = 3) Dose-escalation will stop if DLT exceed limit.~T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time."
10797716|NCT02657343|EG004|Reported Event|Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study]|"Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment.~Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks."
10797717|NCT02657343|EG005|Reported Event|Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study]|"Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle).~Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care."
11196265|NCT02163902|OG001|Outcome|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
11196266|NCT02163902|EG000|Reported Event|ATX-101 (Deoxycholic Acid) Injection|This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
11196267|NCT02163902|EG001|Reported Event|Placebo|This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
10797718|NCT02368132|BG000|Baseline|Usual Care|Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
10803323|NCT01081262|BG000|Baseline|Arm I (Carboplatin and Paclitaxel)|"Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11196268|NCT02163915|BG000|Baseline|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
11196269|NCT02163915|BG001|Baseline|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196270|NCT02163915|BG002|Baseline|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
11196271|NCT02163915|BG003|Baseline|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196272|NCT02163915|BG004|Baseline|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
11196273|NCT02163915|BG005|Baseline|Total|Total of all reporting groups
11196274|NCT02163915|FG000|Participant Flow|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
11196275|NCT02163915|FG001|Participant Flow|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196276|NCT02163915|FG002|Participant Flow|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
11196277|NCT02163915|FG003|Participant Flow|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196278|NCT02163915|FG004|Participant Flow|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
11196279|NCT02163915|OG000|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
11196280|NCT02163915|OG001|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196281|NCT02163915|OG002|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
11196282|NCT02163915|OG003|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196283|NCT02163915|OG004|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
11196284|NCT02163915|OG000|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196285|NCT02163915|OG001|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
10797719|NCT02368132|BG001|Baseline|Individual Delivered TEP Arm|Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
10797720|NCT02368132|BG002|Baseline|Group Delivered TEP Arm|All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
10797721|NCT02368132|BG003|Baseline|Total|Total of all reporting groups
10797722|NCT02368132|FG000|Participant Flow|Usual Care|Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
10797723|NCT02368132|FG001|Participant Flow|Individual Delivered TEP Arm|Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
10797724|NCT02368132|FG002|Participant Flow|Group Delivered TEP Arm|All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
10797725|NCT02368132|OG000|Outcome|Usual Care|Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
10797726|NCT02368132|OG001|Outcome|Individual Delivered TEP Arm|Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
10797727|NCT02368132|OG002|Outcome|Group Delivered TEP Arm|All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
11196286|NCT02163915|OG002|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
10797728|NCT02368132|EG000|Reported Event|Usual Care|Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
10797729|NCT02368132|EG001|Reported Event|Individual Delivered TEP Arm|Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
10797730|NCT02368132|EG002|Reported Event|Group Delivered TEP Arm|All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
10797731|NCT02063724|BG000|Baseline|HER-2 Pulsed Dendritic Cell Vaccine|"6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.~HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes."
11196287|NCT02163915|OG003|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
11196288|NCT02163915|EG000|Reported Event|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
11196289|NCT02163915|EG001|Reported Event|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196290|NCT02163915|EG002|Reported Event|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
11196291|NCT02163915|EG003|Reported Event|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
11196292|NCT02163915|EG004|Reported Event|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
11196293|NCT02163967|BG000|Baseline|All Study Participants|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation, stimulation for 20 minutes on 3 separate days. Subjects were randomized to order of stimulation dose on the 3 days.
11196294|NCT02163967|FG000|Participant Flow|Dose Sequence: Sham, Low, High|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 1milliamp stimulation intensity, Day 3 - 2 milliamp stimulation intensity
10797732|NCT02063724|FG000|Participant Flow|HER-2 Pulsed Dendritic Cell Vaccine|"6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.~HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes."
10797733|NCT02063724|OG000|Outcome|HER-2 Pulsed Dendritic Cell Vaccine|"6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.~HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes."
10797734|NCT02063724|EG000|Reported Event|HER-2 Pulsed Dendritic Cell Vaccine|"6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.~HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes."
10797735|NCT01776723|BG000|Baseline|Phase 1, Level 1: Ruxolitinib 10 mg|Phase 1 Level 1: Ruxolitinib 5 mg twice daily
10797736|NCT01776723|BG001|Baseline|Phase 1, Level 2: Ruxolitinib 20 mg|Phase 1 Level 2: Ruxolitinib 10 mg twice daily
10797737|NCT01776723|BG002|Baseline|Phase 1, Level 3: Ruxolitinib 30 mg|Phase 1 Level 3: Ruxolitinib 15 mg twice daily
10797738|NCT01776723|BG003|Baseline|Phase 1, Level 4: Ruxolitinib 40 mg|Phase 1 Level 4: Ruxolitinib 20 mg twice daily
10797739|NCT01776723|BG004|Baseline|Phase 2: Maximum Tolerated Dose - Ruxolitinib|Phase 2: Treatment at Maximum Tolerated Dose (MTD).
10797740|NCT01776723|BG005|Baseline|Total|Total of all reporting groups
10797741|NCT01776723|FG000|Participant Flow|Phase 1, Level 1: Ruxolitinib 10 mg|Phase 1, Level 1: Ruxolitinib 5 mg twice daily
10797742|NCT01776723|FG001|Participant Flow|Phase 1 Level 2: Ruxolitinib 20 mg|Phase 1 Level 2: Ruxolitinib 10 mg twice daily
10797743|NCT01776723|FG002|Participant Flow|Phase 1 Level 3: Ruxolitinib 30 mg|Phase 1 Level 3: Ruxolitinib 15 mg twice daily
10797744|NCT01776723|FG003|Participant Flow|Phase 1 Level 4: 40 mg Ruxolitinib|Phase 1 Level 4: 20 mg Ruxolitinib twice daily
10797745|NCT01776723|FG004|Participant Flow|Phase 2: Maximum Tolerated Dose - Ruxolitinib|Phase II: Treatment at Maximum Tolerated Dose (MTD).
10797746|NCT01776723|OG000|Outcome|I: Dose Escalation - Ruxolitinib|"Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day [BID] dosing) according to the rolling six Phase I design.~Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD."
10797747|NCT01776723|OG000|Outcome|II: Maximum Tolerated Dose - Ruxolitinib|"Phase II: Treatment at Maximum Tolerated Dose (MTD).~Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD."
11196295|NCT02163967|FG001|Participant Flow|Dose Sequence: Sham, High, Low|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 2 milliamp stimulation intensity, Day 3 - 1 milliamp stimulation intensity
11196296|NCT02163967|FG002|Participant Flow|Dose Sequence: Low, Sham, High|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - Sham stimulation, Day 3 - 2 milliamp stimulation intensity
11196297|NCT02163967|FG003|Participant Flow|Dose Sequence; Low, High, Sham|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - 2 milliamp stimulation intensity, Day 3 - Sham stimulation
11196298|NCT02163967|FG004|Participant Flow|Dose Sequence: High, Sham, Low|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 2 milliamp stimulation intensity , Day 2 - Sham stimulation, Day 3 - 1 milliamp stimulation intensity
11196299|NCT02163967|FG005|Participant Flow|Dose Sequence: High, Low, Sham|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 2 milliamp stimulation intensity , Day 2 - 1 milliamp stimulation intensity, Day 3 - Sham stimulation
11196300|NCT02163967|OG000|Outcome|Sham Stimulation|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes
11196301|NCT02163967|OG001|Outcome|Low Dose|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose
11196302|NCT02163967|OG002|Outcome|High Dose|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose
11202301|NCT02206828|OG002|Outcome|Ease of Use - Mesh Easy to Insert|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
10797748|NCT01776723|OG000|Outcome|All Participants|All participants who received at least one dose of Ruxuxolitinib
10797749|NCT01776723|OG000|Outcome|II: Maximum Tolerated Dose - Ruxolitinib|Phase II: Treatment at Maximum Tolerated Dose (MTD).
10797750|NCT01776723|OG000|Outcome|Phase 1, Level 1: Ruxolitinib 10 mg|Phase 1, Level 1: Ruxolitinib 5 mg twice daily
10797751|NCT01776723|OG001|Outcome|Phase 1, Level 2: Ruxolitinib 20 mg|Phase 1, Level 2: Ruxolitinib 10 mg twice daily
10797752|NCT01776723|OG002|Outcome|Phase 1, Level 3: Ruxolitinib 30 mg|Phase 1 Level 3: Ruxolitinib 15 mg twice daily
10797753|NCT01776723|OG003|Outcome|Phase 1, Level 4: Ruxolitinib 40 mg|Phase 1, Level 4: Ruxolitinib 20 mg twice daily
10797754|NCT01776723|OG004|Outcome|Maximum Tolerated Dose - Ruxolitinib|Treatment at Maximum Tolerated Dose (MTD).
10797755|NCT01776723|EG000|Reported Event|Phase 1, Level 1: Ruxolitinib 10 mg|Phase 1, Level 1: Ruxolitinib 5 mg twice daily
10797756|NCT01776723|EG001|Reported Event|Phase 1, Level 2: Ruxolitinib 20 mg|Phase 1, Level 1: Ruxolitinib 10 mg twice daily
10797757|NCT01776723|EG002|Reported Event|Phase 1, Level 3: Ruxolitinib 30 mg|Phase 1, Level 1: Ruxolitinib 15 mg twice daily
10797758|NCT01776723|EG003|Reported Event|Phase 1, Level 4: Ruxolitinib 40 mg|Phase 1, Level 1: Ruxolitinib 20 mg twice daily
10797759|NCT01776723|EG004|Reported Event|II: Maximum Tolerated Dose - Ruxolitinib|Phase II: Treatment at Maximum Tolerated Dose (MTD).
10797760|NCT01119807|BG000|Baseline|Intravenous|Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.
10797761|NCT01119807|BG001|Baseline|Humeral IO|Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.
10797762|NCT01119807|BG002|Baseline|Tibial IO|TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
10797763|NCT01119807|BG003|Baseline|Total|Total of all reporting groups
10797764|NCT01119807|FG000|Participant Flow|Intravenous|Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.
10797765|NCT01119807|FG001|Participant Flow|Humeral IO|Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.
10797766|NCT01119807|FG002|Participant Flow|Tibial IO|TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
10797767|NCT01119807|OG000|Outcome|Intravenous|Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.
10797768|NCT01119807|OG001|Outcome|Humeral IO|Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.
10797769|NCT01119807|OG002|Outcome|Tibial IO|TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
10797770|NCT01119807|EG000|Reported Event|Intravenous|Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.
10797771|NCT01119807|EG001|Reported Event|Humeral IO|Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.
10797772|NCT01119807|EG002|Reported Event|Tibial IO|TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
10797773|NCT00601900|BG000|Baseline|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797774|NCT00601900|BG001|Baseline|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797775|NCT00601900|BG002|Baseline|Total|Total of all reporting groups
10797776|NCT00601900|FG000|Participant Flow|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797777|NCT00601900|FG001|Participant Flow|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797778|NCT00601900|OG000|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797779|NCT00601900|OG001|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797780|NCT00601900|EG000|Reported Event|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10797781|NCT00601900|EG001|Reported Event|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11196303|NCT02163967|OG000|Outcome|Sham|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11196304|NCT02163967|OG001|Outcome|Low Dose|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 minutes, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11384074|NCT00001322|BG000|Baseline|Phase 1 - Lupron|Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly before randomization to estradiol or progesterone arm in the crossover phase of the study.
11384075|NCT00001322|FG000|Participant Flow|Phase 1 - Lupron|Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
10797782|NCT01295944|BG000|Baseline|1/Carboplatin and Bevacizumab for Recurrent Ependymoma|"The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.~Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician~Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician."
11196305|NCT02163967|OG002|Outcome|High Dose|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11196306|NCT02163967|EG000|Reported Event|Sham|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11196307|NCT02163967|EG001|Reported Event|Low Dose|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 mintues, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11196308|NCT02163967|EG002|Reported Event|High Dose|"Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once~Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation"
11384076|NCT00001322|FG001|Participant Flow|Phase 2, Arm 1 - Estradiol, Then Progesterone|12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly. Additionally, 4 weeks of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 5 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day). Followed by 1-2 weeks (weeks 6-7) washout period. Then crossover to 5 weeks (week 8-12) of Progesterone suppositories (200mg vaginally twice/day) and placebo patches.
10803324|NCT01081262|BG001|Baseline|Arm II (Oxaliplatin and Capecitabine)|"Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
11196309|NCT02163993|BG000|Baseline|Placebo|Placebo given as SQ injections once every 28 days during a 12 week treatment period.
11196310|NCT02163993|BG001|Baseline|5mg Galcanezumab|5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
11196311|NCT02163993|BG002|Baseline|50mg Galcanezumab|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196312|NCT02163993|BG003|Baseline|120mg Galcanezumab|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196313|NCT02163993|BG004|Baseline|300mg Galcanezumab|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196314|NCT02163993|BG005|Baseline|Total|Total of all reporting groups
11196315|NCT02163993|FG000|Participant Flow|Placebo|Placebo given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
11196316|NCT02163993|FG001|Participant Flow|5mg Galcanezumab|5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196317|NCT02163993|FG002|Participant Flow|50mg Galcanezumab|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196318|NCT02163993|FG003|Participant Flow|120mg Galcanezumab|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196319|NCT02163993|FG004|Participant Flow|300mg Galcanezumab|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196320|NCT02163993|OG000|Outcome|Placebo|Placebo given as SQ injections once every 28 days during a 12 week treatment period.
11196321|NCT02163993|OG001|Outcome|5mg Galcanezumab|5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
11196322|NCT02163993|OG002|Outcome|50mg Galcanezumab|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196323|NCT02163993|OG003|Outcome|120mg Galcanezumab|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11384077|NCT00001322|FG002|Participant Flow|Phase 2, Arm 2 - Progesterone, Then Estradiol|12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly. Additionally, 5 weeks of Progesterone suppositories (200mg vaginally twice/day) and placebo patches. Followed by 1-2 weeks (weeks 6-7) washout period. Then crossover to 4 weeks (weeks 8-11) of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 12 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day).
11384078|NCT00001322|OG000|Outcome|Phase 1 - Lupron|Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
10797783|NCT01295944|FG000|Participant Flow|1/Carboplatin and Bevacizumab for Recurrent Ependymoma|"The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.~Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician~Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician."
10797784|NCT01295944|OG000|Outcome|1/Carboplatin and Bevacizumab for Recurrent Ependymoma|"The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.~Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician~Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician."
10797785|NCT01295944|EG000|Reported Event|1/Carboplatin and Bevacizumab for Recurrent Ependymoma|"The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.~Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician~Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician."
10797786|NCT01285557|BG000|Baseline|S-1+Cisplatin|Participants received S-1 25 mg/m^2 orally BID every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797787|NCT01285557|BG001|Baseline|5FU+Cisplatin|Participants received 5-FU 800 mg/m^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797788|NCT01285557|BG002|Baseline|Total|Total of all reporting groups
10797789|NCT01285557|FG000|Participant Flow|S-1+Cisplatin|Participants received S-1 25 milligrams per meter square (mg/m^2) orally twice daily (BID) every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m^2 as a 1- to 3-hour intravenous (IV) infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until progression of disease (PD), adverse event (AE), withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797790|NCT01285557|FG001|Participant Flow|5FU+Cisplatin|Participants received 5-FU 800 mg/m^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797791|NCT01285557|OG000|Outcome|S-1+Cisplatin|Participants received S-1 25 mg/m^2 orally BID every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797792|NCT01285557|OG001|Outcome|5FU+Cisplatin|Participants received 5-FU 800 mg/m^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
11196324|NCT02163993|OG004|Outcome|300mg Galcanezumab|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196325|NCT02163993|OG000|Outcome|5mg Galcanezumab|5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
11196326|NCT02163993|OG001|Outcome|50mg Galcanezumab|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196327|NCT02163993|OG002|Outcome|120mg Galcanezumab|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196328|NCT02163993|OG003|Outcome|300mg Galcanezumab|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196329|NCT02163993|EG000|Reported Event|Placebo - Treatment Phase|Placebo given as SQ injections once every 28 days during a 12 week treatment period.
10797793|NCT01285557|EG000|Reported Event|S-1+Cisplatin|Participants received S-1 25 mg/m^2 orally BID every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797794|NCT01285557|EG001|Reported Event|5FU+Cisplatin|Participants received 5-FU 800 mg/m^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
10797795|NCT01032603|BG000|Baseline|Bilateral Lateral Rectus Recession|"Bilateral lateral rectus recession surgery~Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery"
10797796|NCT01032603|BG001|Baseline|Unilateral Lateral Rectus Recession|"Unilateral lateral rectus recession w/ medial rectus resection surgery~Unilateral lateral rectus recession with medial rectus resection (R&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded."
10797797|NCT01032603|BG002|Baseline|Total|Total of all reporting groups
10797798|NCT01032603|FG000|Participant Flow|Bilateral Lateral Rectus Recession|"Bilateral lateral rectus recession surgery~Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery"
10797799|NCT01032603|FG001|Participant Flow|Unilateral Lateral Rectus Recession|"Unilateral lateral rectus recession w/ medial rectus resection surgery~Unilateral lateral rectus recession with medial rectus resection (R&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded."
10797800|NCT01032603|OG000|Outcome|Bilateral Lateral Rectus Recession|"Bilateral lateral rectus recession surgery~Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery"
11384079|NCT00001322|OG001|Outcome|Phase 2 - Estradiol|4 weeks of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 5 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day).
10797801|NCT01032603|OG001|Outcome|Unilateral Lateral Rectus Recession|"Unilateral lateral rectus recession w/ medial rectus resection surgery~Unilateral lateral rectus recession with medial rectus resection (R&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded."
10797802|NCT01032603|EG000|Reported Event|Bilateral Lateral Rectus Recession|"Bilateral lateral rectus recession surgery~Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery"
10797803|NCT01032603|EG001|Reported Event|Unilateral Lateral Rectus Recession|"Unilateral lateral rectus recession w/ medial rectus resection surgery~Unilateral lateral rectus recession with medial rectus resection (R&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded."
10797804|NCT00977691|BG000|Baseline|PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and no posttransplant cyclophosphamide (PT-Cy).
10797805|NCT00977691|BG001|Baseline|PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 50 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797806|NCT00977691|BG002|Baseline|PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 100 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797807|NCT00977691|BG003|Baseline|Total|Total of all reporting groups
10797808|NCT00977691|FG000|Participant Flow|PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and no posttransplant cyclophosphamide (PT-Cy).
10797809|NCT00977691|FG001|Participant Flow|PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 50 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797810|NCT00977691|FG002|Participant Flow|PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 100 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797811|NCT00977691|OG000|Outcome|PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and no posttransplant cyclophosphamide (PT-Cy).
10797812|NCT00977691|OG001|Outcome|PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 50 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797813|NCT00977691|OG002|Outcome|PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 100 mg/kg posttransplant cyclophosphamide (PT-Cy).
11196330|NCT02163993|EG001|Reported Event|5mg Galcanezumab-Treatment Phase|5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11384080|NCT00001322|OG002|Outcome|Phase 2 - Progesterone|5 weeks of Progesterone suppositories (200mg vaginally twice/day) and placebo patches.
11384081|NCT00001322|EG000|Reported Event|Lupron|Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
10797814|NCT00977691|OG000|Outcome|Participants Who Engrafted Following Stem Cell Transplant|Engrafted participants received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and posttransplant cyclophosphamide (PT-Cy) from 0 to 100 mg/kg, followed by infusion of haploidentical stem cells.
10797815|NCT00977691|OG001|Outcome|Participants Who Rejected Engraftment Following Stem Cell Transplant|Engrafted participants received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and posttransplant cyclophosphamide (PT-Cy) from 0 to 100 mg/kg, followed by infusion of haploidentical stem cells.
10797816|NCT00977691|EG000|Reported Event|PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and no posttransplant cyclophosphamide (PT-Cy).
10797817|NCT00977691|EG001|Reported Event|PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 50 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797818|NCT00977691|EG002|Reported Event|PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy)|Patients received a regimen consisting of alemtuzumab, 400 cGy total body irradiation (TBI), sirolimus, and 100 mg/kg posttransplant cyclophosphamide (PT-Cy).
10797819|NCT00964002|BG000|Baseline|Efavirenz|"Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).~Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).~efavirenz"
10797820|NCT00964002|FG000|Participant Flow|Efavirenz|"Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).~Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days). As dose increase is protocol/standard and we are not in a dose escalation trial (Phase I), patients with dose escalation will not be described or analyzed for the primary endpoint."
10797821|NCT00964002|OG000|Outcome|Efavirenz|"Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).~Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).~efavirenz"
10797822|NCT00964002|EG000|Reported Event|Efavirenz|"Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).~Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).~efavirenz"
10803325|NCT01081262|BG002|Baseline|Arm III (Carboplatin, Paclitaxel, Bevacizumab)|"Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803326|NCT01081262|BG003|Baseline|Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)|"Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.~Bevacizumab: Given IV~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803327|NCT01081262|BG004|Baseline|Total|Total of all reporting groups
10803328|NCT01081262|FG000|Participant Flow|Arm I (Carboplatin and Paclitaxel)|"Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803329|NCT01081262|FG001|Participant Flow|Arm II (Oxaliplatin and Capecitabine)|"Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803330|NCT01081262|FG002|Participant Flow|Arm III (Carboplatin, Paclitaxel, Bevacizumab)|"Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11196331|NCT02163993|EG002|Reported Event|50mg Galcanezumab-Treatment Phase|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
10803331|NCT01081262|FG003|Participant Flow|Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)|"Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.~Bevacizumab: Given IV~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
11196332|NCT02163993|EG003|Reported Event|120mg Galcanezumab-Treatment Phase|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11384082|NCT00001322|EG001|Reported Event|Phase 2 - Estradiol|4 weeks of transdermal Estradiol (100mcg/day by skin patch)
11384083|NCT00001322|EG002|Reported Event|Phase 2 - Progesterone|5 weeks of Progesterone suppositories (200mg vaginally twice/day)
10797823|NCT00887783|BG000|Baseline|B: 66Gy/33F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).~Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)"
10797824|NCT00887783|BG001|Baseline|A: 60Gy/30F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)"
10797825|NCT00887783|BG002|Baseline|Total|Total of all reporting groups
10797826|NCT00887783|FG000|Participant Flow|B: 66Gy/33F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).~Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)"
10797827|NCT00887783|FG001|Participant Flow|A: 60Gy/30F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)"
10797828|NCT00887783|OG000|Outcome|B: 66Gy/33F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).~Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)"
10797829|NCT00887783|OG001|Outcome|A: 60Gy/30F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)"
10797830|NCT00887783|EG000|Reported Event|B: 66Gy/33F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).~Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)"
10797831|NCT00887783|EG001|Reported Event|A: 60Gy/30F+Navelbine Oral 150 mg q3w|"Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization~Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks~60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)"
10797832|NCT00790218|BG000|Baseline|CF102|CF102: CF102 capsules twice daily by mouth
10797833|NCT00790218|FG000|Participant Flow|CF102 1mg|CF102: CF102 tablets were given orally twice daily
10797834|NCT00790218|FG001|Participant Flow|CF102 5mg|CF102: CF102 tablets were given orally twice daily
10797835|NCT00790218|FG002|Participant Flow|CF102 25mg|CF102: CF102 tablets were given orally twice daily
10797836|NCT00790218|OG000|Outcome|CF102 1mg|CF102 tablets given orally, BID
10797837|NCT00790218|OG001|Outcome|CF102 5mg|CF102 tablets given orally, BID
10797838|NCT00790218|OG002|Outcome|CF102 25mg|CF102 tablets given orally, BID
10797839|NCT00790218|EG000|Reported Event|CF102 1mg|CF102: CF102 capsules twice daily by mouth
10797840|NCT00790218|EG001|Reported Event|CF102 5mg|CF102: CF102 capsules twice daily by mouth
10797841|NCT00790218|EG002|Reported Event|CF102 25mg|CF102: CF102 capsules twice daily by mouth
10797842|NCT00583778|BG000|Baseline|Levalbuterol|"levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797843|NCT00583778|BG001|Baseline|Levalbuterol Plus Ipratropium|"ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797844|NCT00583778|BG002|Baseline|Total|Total of all reporting groups
10797845|NCT00583778|FG000|Participant Flow|Levalbuterol|"levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797846|NCT00583778|FG001|Participant Flow|Levalbuterol Plus Ipratropium|"ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797847|NCT00583778|OG000|Outcome|Levalbuterol|levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)
10797848|NCT00583778|OG001|Outcome|Levalbuterol Plus Ipratropium|"ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797849|NCT00583778|EG000|Reported Event|Levalbuterol|"levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
10797850|NCT00583778|EG001|Reported Event|Levalbuterol Plus Ipratropium|"ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses~ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses"
11241217|NCT02485561|BG002|Baseline|Survivor Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241218|NCT02485561|BG003|Baseline|Total|Total of all reporting groups
11241219|NCT02485561|FG000|Participant Flow|Information Only|"INTERVENTION: Information about colon cancer and screening tests.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241220|NCT02485561|FG001|Participant Flow|Screener Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241221|NCT02485561|FG002|Participant Flow|Survivor Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241222|NCT02485561|OG000|Outcome|Information Only|"INTERVENTION: Information about colon cancer and screening tests.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241223|NCT02485561|OG001|Outcome|Screener Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241224|NCT02485561|OG002|Outcome|Survivor Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241225|NCT02485561|EG000|Reported Event|Information Only|"INTERVENTION: Information about colon cancer and screening tests.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241226|NCT02485561|EG001|Reported Event|Screener Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241227|NCT02485561|EG002|Reported Event|Survivor Narrative|"INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer~Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.~Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests."
11241228|NCT02485704|BG000|Baseline|Natroba (Spinosad)|"Spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~Spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
10797863|NCT00432094|BG000|Baseline|2 Transplants/1 Transplant Arms (Overall)|Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.
11241229|NCT02485704|BG001|Baseline|Placebo|"Placebo is a topical suspension that is the same formulation as Natroba without the active ingredient, spinosad (vehicle). Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient, spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241230|NCT02485704|BG002|Baseline|Total|Total of all reporting groups
11241231|NCT02485704|FG000|Participant Flow|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11384084|NCT01701583|BG000|Baseline|Omalizumab|Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
11384085|NCT01701583|BG001|Baseline|Controls|Control subjects without urticaria who did not receive omalizumab
11384086|NCT01701583|BG002|Baseline|Total|Total of all reporting groups
11384087|NCT01701583|FG000|Participant Flow|Omalizumab|Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks
11384088|NCT01701583|FG001|Participant Flow|Controls|Control subjects without urticaria who did not receive omalizumab
11384089|NCT01701583|OG000|Outcome|Omalizumab Responders|Subjects with chronic urticaria, treated with omalizumab who responded to the drug
11384090|NCT01701583|OG001|Outcome|Controls|Subjects without chronic urticaria, not treated with omalizumab
11384091|NCT01701583|OG002|Outcome|Omalizumab Non-responders|Subjects with chronic urticaria, treated with omalizumab who did not respond to the drug
11384092|NCT01701583|EG000|Reported Event|Omalizumab|Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks
11384093|NCT01701583|EG001|Reported Event|Controls|Control subjects without urticaria who did not receive omalizumab
11384094|NCT01714817|BG000|Baseline|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
11384095|NCT01714817|BG001|Baseline|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
11384096|NCT01714817|BG002|Baseline|Total|Total of all reporting groups
11384097|NCT01714817|FG000|Participant Flow|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
11384098|NCT01714817|FG001|Participant Flow|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
11384099|NCT01714817|OG000|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
11384100|NCT01714817|OG001|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
11384101|NCT01714817|OG000|Outcome|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.
11196333|NCT02163993|EG004|Reported Event|300mg Galcanezumab-Treatment Phase|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11384102|NCT01714817|OG001|Outcome|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.
11384103|NCT01714817|EG000|Reported Event|Abatacept IV|Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
11384104|NCT01714817|EG001|Reported Event|Placebo IV|Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
11384105|NCT01755689|BG000|Baseline|Nimenrix+Cervarix (1,2,7-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384106|NCT01755689|BG001|Baseline|Nimenrix+Cervarix (0,1,6-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384107|NCT01755689|BG002|Baseline|Cervarix Group|Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
11384108|NCT01755689|BG003|Baseline|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384109|NCT01755689|BG004|Baseline|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384110|NCT01755689|BG005|Baseline|Total|Total of all reporting groups
11384111|NCT01755689|FG000|Participant Flow|Nimenrix+Cervarix (1,2,7-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384112|NCT01755689|FG001|Participant Flow|Nimenrix+Cervarix (0,1,6-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384113|NCT01755689|FG002|Participant Flow|Cervarix Group|Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
11384114|NCT01755689|FG003|Participant Flow|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384115|NCT01755689|FG004|Participant Flow|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384116|NCT01755689|OG000|Outcome|Nimenrix+Cervarix (1,2,7-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384117|NCT01755689|OG001|Outcome|Nimenrix+Cervarix (0,1,6-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384118|NCT01755689|OG002|Outcome|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384119|NCT01755689|OG000|Outcome|Nimenrix+Cervarix (0,1,6-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384120|NCT01755689|OG001|Outcome|Cervarix Group|Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
11384121|NCT01755689|OG003|Outcome|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384122|NCT01755689|OG000|Outcome|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384123|NCT01755689|OG001|Outcome|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384124|NCT01755689|OG002|Outcome|Cervarix Group|Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
11384125|NCT01755689|OG003|Outcome|Nimenrix+Boostrix+Cervarix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384126|NCT01755689|OG004|Outcome|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384127|NCT01755689|OG003|Outcome|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384128|NCT01755689|OG000|Outcome|Nimenrix+Boostrix+Cervarix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384129|NCT01755689|EG000|Reported Event|Nimenrix+Cervarix (1,2,7-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384130|NCT01755689|EG001|Reported Event|Nimenrix+Cervarix (0,1,6-Month) Group|Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384131|NCT01755689|EG002|Reported Event|Cervarix Group|Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
11384132|NCT01755689|EG003|Reported Event|Nimenrix+Cervarix+Boostrix Group|Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11384133|NCT01755689|EG004|Reported Event|Boostrix+Cervarix Group|Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
11196334|NCT02163993|EG005|Reported Event|Placebo - Post-Treatment Phase|Placebo given as SQ injections once every 28 days during a 12 week treatment period.
11196335|NCT02163993|EG006|Reported Event|5mg Galcanezumab-Post-Treatment Phase|5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
10797864|NCT00432094|FG000|Participant Flow|2 Transplants|"Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.~carboplatin: Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes~etoposide: 600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3.~thiotepa: 150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4~autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)~filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days."
10797865|NCT00432094|FG001|Participant Flow|1 Transplant|"Patients with Germ cell tumors who receive one transplant only.~ifosfamide: 2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.~paclitaxel: 225 mg/m^2 intravenous over 3 hours on Day -7.~autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)~Mesna: 2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.~filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days."
10797866|NCT00432094|OG000|Outcome|2 Transplants|"Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.~carboplatin: Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes~etoposide: 600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3.~thiotepa: 150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4~autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)~filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days."
10797867|NCT00432094|OG001|Outcome|1 Transplant|"Patients with Germ cell tumors who receive one transplant only.~ifosfamide: 2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.~paclitaxel: 225 mg/m^2 intravenous over 3 hours on Day -7.~autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)~Mesna: 2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.~filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days."
10797868|NCT00432094|EG000|Reported Event|2 Transplants/1 Transplant Arms (Overall)|"Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.~Adverse events are not separable by number of transplants because they were not recorded in to the University of Minnesota's CTMS system. Below you will see AEs for patients with 1 and 2 transplants pooled together."
10797869|NCT00416351|BG000|Baseline|4 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797870|NCT00416351|BG001|Baseline|8 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797871|NCT00416351|BG002|Baseline|13.2 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797872|NCT00416351|BG003|Baseline|20 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797873|NCT00416351|BG004|Baseline|28 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797874|NCT00416351|BG005|Baseline|Total|Total of all reporting groups
10797875|NCT00416351|FG000|Participant Flow|4 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797876|NCT00416351|FG001|Participant Flow|8 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797877|NCT00416351|FG002|Participant Flow|13.2 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797878|NCT00416351|FG003|Participant Flow|20 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797879|NCT00416351|FG004|Participant Flow|28 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797880|NCT00416351|OG000|Outcome|Clofarabine|"Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.~clofarabine"
10797881|NCT00416351|OG000|Outcome|4 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797882|NCT00416351|OG001|Outcome|8 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
10797883|NCT00416351|OG002|Outcome|13.2 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
10797884|NCT00416351|OG003|Outcome|20 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
10797885|NCT00416351|OG004|Outcome|28 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
11196336|NCT02163993|EG007|Reported Event|50mg Galcanezumab-Post-Treatment Phase|50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11196337|NCT02163993|EG008|Reported Event|120mg Galcanezumab-Post-Treatment Phase|120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
10797886|NCT00416351|OG001|Outcome|8 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797887|NCT00416351|OG002|Outcome|13.2 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797888|NCT00416351|OG003|Outcome|20 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797889|NCT00416351|OG004|Outcome|28 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797890|NCT00416351|EG000|Reported Event|4 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797891|NCT00416351|EG001|Reported Event|8 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797892|NCT00416351|EG002|Reported Event|13.2 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797893|NCT00416351|EG003|Reported Event|20 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797894|NCT00416351|EG004|Reported Event|28 mg/m2/Day Clofarabine|Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
10797895|NCT00145600|BG000|Baseline|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
10797896|NCT00145600|BG001|Baseline|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
10797897|NCT00145600|BG002|Baseline|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
10797898|NCT00145600|BG003|Baseline|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
10797899|NCT00145600|BG004|Baseline|Total|Total of all reporting groups
10797900|NCT00145600|FG000|Participant Flow|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
10797901|NCT00145600|FG001|Participant Flow|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
10797902|NCT00145600|FG002|Participant Flow|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
10797903|NCT00145600|FG003|Participant Flow|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
10797904|NCT00145600|OG000|Outcome|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
10797905|NCT00145600|OG001|Outcome|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
10797906|NCT00145600|OG002|Outcome|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
10797907|NCT00145600|OG003|Outcome|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
10797908|NCT00145600|OG000|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
10797909|NCT00145600|OG001|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
10797910|NCT00145600|OG002|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
10797911|NCT00145600|OG003|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
10797912|NCT00145600|OG004|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
10797913|NCT00145600|OG005|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
10797914|NCT00145600|OG006|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
10797915|NCT00145600|OG007|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
10797916|NCT00145600|OG000|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
10797917|NCT00145600|OG001|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
11384134|NCT01762761|BG000|Baseline|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384135|NCT01762761|BG001|Baseline|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384136|NCT01762761|BG002|Baseline|Total|Total of all reporting groups
11384137|NCT01762761|FG000|Participant Flow|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384138|NCT01762761|FG001|Participant Flow|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384139|NCT01762761|OG000|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384140|NCT01762761|OG001|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384141|NCT01762761|OG000|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
11384142|NCT01762761|EG000|Reported Event|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384143|NCT01762761|EG001|Reported Event|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
11384161|NCT01774370|BG000|Baseline|Pradaxa Group|"Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:~Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )~Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)"
11384162|NCT01774370|FG000|Participant Flow|Pradaxa Group|"Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:~Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )~Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)"
11384163|NCT01774370|OG000|Outcome|Pradaxa Group|"Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:~Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )~Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)"
11384164|NCT01774370|EG000|Reported Event|Pradaxa Group|"Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:~Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )~Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)"
10797918|NCT00145600|OG002|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
10797919|NCT00145600|OG003|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
10797920|NCT00145600|OG004|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
11384165|NCT01777295|BG000|Baseline|HBsAg/AS_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384166|NCT01777295|BG001|Baseline|Engerix-B_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384167|NCT01777295|BG002|Baseline|Total|Total of all reporting groups
11384168|NCT01777295|FG000|Participant Flow|HBsAg/AS_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384169|NCT01777295|FG001|Participant Flow|Engerix-B_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
10797921|NCT00145600|OG005|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
11384144|NCT01763788|BG000|Baseline|Phase 1b: Cohort 1|"Gemcitabine at a dose of 1000 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384145|NCT01763788|BG001|Baseline|Phase 1b: Cohort 2|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384146|NCT01763788|BG002|Baseline|Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384147|NCT01763788|BG003|Baseline|Phase 2: GC (Gemcitabine, Cisplatin)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles."
11384148|NCT01763788|BG004|Baseline|Total|Total of all reporting groups
11384149|NCT01763788|FG000|Participant Flow|Phase 1b: Cohort 1|"Gemcitabine at a dose of 1000 mg/m^2 (milligrams per square meter) was administered over approximately 30 minutes intravenously (IV) on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384150|NCT01763788|FG001|Participant Flow|Phase 1b: Cohort 2|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384151|NCT01763788|FG002|Participant Flow|Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384152|NCT01763788|FG003|Participant Flow|Phase 2: GC (Gemcitabine, Cisplatin)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles."
11384153|NCT01763788|OG000|Outcome|Phase 1b: Cohort 1|"Gemcitabine at a dose of 1000 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384154|NCT01763788|OG001|Outcome|Phase 1b: Cohort 2|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384155|NCT01763788|OG000|Outcome|Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384156|NCT01763788|OG001|Outcome|Phase 2: GC (Gemcitabine, Cisplatin)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles."
11384157|NCT01763788|EG000|Reported Event|Phase 1b: Cohort 1|Gemcitabine at a dose of 1000 mg/m^2 (milligrams per square meter) was administered over approximately 30 minutes intravenously (IV) on Days 1 and 8 of each cycle for a maximum of 4 cycles.
11384158|NCT01763788|EG001|Reported Event|Phase 1b: Cohort 2|Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.
10797922|NCT00145600|EG000|Reported Event|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
10797923|NCT00145600|EG001|Reported Event|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
11384159|NCT01763788|EG002|Reported Event|Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles.~Necitumumab at a dose of 800 mg was administered over approximately 50 minutes intravenously IV on Days 1 and 8 of each 3-week cycle."
11384160|NCT01763788|EG003|Reported Event|Phase 2: GC (Gemcitabine, Cisplatin)|"Gemcitabine at a dose of 1250 mg/m^2 was administered over approximately 30 minutes IV on Days 1 and 8 of each cycle for a maximum of 4 cycles.~Cisplatin at a dose of 75 mg/m^2 was administered over approximately 120 minutes IV on Day 1 for a maximum of 4 cycles."
10797924|NCT00145600|EG002|Reported Event|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
10797925|NCT00145600|EG003|Reported Event|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
10797926|NCT00072358|BG000|Baseline|Participants With Refractory Bone Marrow Disease and High Risk of Recurrence|Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups
10797927|NCT00072358|FG000|Participant Flow|Participants With Refractory Bone Marrow Disease and High Risk of Recurrence|Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups
10797928|NCT00072358|OG000|Outcome|Participants With Refractory Bone Marrow Disease and High Risk of Recurrence|Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8
10797929|NCT00072358|EG000|Reported Event|Participants With Refractory Bone Marrow Disease and High Risk of Recurrence|Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups.
10803332|NCT01081262|OG000|Outcome|Arm I (Carboplatin and Paclitaxel)|"Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803333|NCT01081262|OG001|Outcome|Arm II (Oxaliplatin and Capecitabine)|"Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803334|NCT01081262|OG002|Outcome|Arm III (Carboplatin, Paclitaxel, Bevacizumab)|"Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803335|NCT01081262|OG003|Outcome|Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)|"Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.~Bevacizumab: Given IV~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803336|NCT01081262|EG000|Reported Event|Arm I (Carboplatin and Paclitaxel)|"Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803337|NCT01081262|EG001|Reported Event|Arm II (Oxaliplatin and Capecitabine)|"Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803338|NCT01081262|EG002|Reported Event|Arm III (Carboplatin, Paclitaxel, Bevacizumab)|"Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10803339|NCT01081262|EG003|Reported Event|Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)|"Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.~Bevacizumab: Given IV~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Oxaliplatin: Given IV~Quality-of-Life Assessment: Ancillary studies"
11196338|NCT02163993|EG009|Reported Event|300mg Galcanezumab-Post-Treatment Phase|300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
11384170|NCT01777295|OG000|Outcome|HBsAg/AS_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384171|NCT01777295|OG001|Outcome|Engerix-B_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384172|NCT01777295|OG000|Outcome|HBsAg/AS_2 Group|Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm
11384173|NCT01777295|OG001|Outcome|Engerix-B_2 Group|Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384174|NCT01777295|OG000|Outcome|Engerix-B_2 Group|Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384175|NCT01777295|OG001|Outcome|Engerix-B_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm
11384176|NCT01777295|OG000|Outcome|HBsAg/AS_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm
11384177|NCT01777295|OG000|Outcome|HBsAg/AS_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384178|NCT01777295|OG001|Outcome|Engerix-B_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384179|NCT01777295|OG000|Outcome|HBsAg/AS_2 Group|Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384180|NCT01777295|OG001|Outcome|Engerix-B_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384181|NCT01777295|OG000|Outcome|HBsAg/AS_1 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the nondominant upper arm.
11384182|NCT01777295|EG000|Reported Event|HBsAg/AS_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
11384183|NCT01777295|EG001|Reported Event|Engerix-B_1+2 Group|Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
10797930|NCT03089281|BG000|Baseline|SmartDelay™ Algorithm|AV Delay and pacing chamber were determined by SmartDelay algorithm
11241232|NCT02485704|FG001|Participant Flow|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad (vehicle). Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241233|NCT02485704|OG000|Outcome|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241234|NCT02485704|OG001|Outcome|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad (vehicle). Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241235|NCT02485704|EG000|Reported Event|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241236|NCT02485704|EG001|Reported Event|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad (vehicle). Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241237|NCT02485717|BG000|Baseline|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241238|NCT02485717|BG001|Baseline|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241239|NCT02485717|BG002|Baseline|PK Natroba (Spinosad)|"open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241240|NCT02485717|BG003|Baseline|Total|Total of all reporting groups
11241241|NCT02485717|FG000|Participant Flow|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241242|NCT02485717|FG001|Participant Flow|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241243|NCT02485717|FG002|Participant Flow|PK Natroba (Spinosad)|"open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241244|NCT02485717|OG000|Outcome|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241245|NCT02485717|OG001|Outcome|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241246|NCT02485717|OG000|Outcome|Pharmacokentic Study|Approximately 24 unique pediatric subjects participated in the PK study. The PK study included approximately 12 male or female subjects aged 4 to 9 years, with a minimum of 6 male or female subjects aged 4 to 6 years; and 12 male or female subjects aged 10 to 16 years. Natroba was applied at the study center during a single visit (Day 1 or Day 2 [only if screening assessments were completed on Day 1]) with assistance from a caregiver according to the same instructions and time restrictions as described for the primary study. Blood samples were collected at 0 hours (just prior to treatment), and then at 0.5, 1.0, 3.0, 6.0, and 12 hours post-treatment (with a ± 5-minute window for each post-treatment time point). The subjects remained at the study center until the 12-hour procedures were completed. Bathing must have occurred after the 6-hour blood draw but prior to the 12-hour blood draw.
10797931|NCT03089281|BG001|Baseline|Fixed AV Delay With BiV Pacing|Fixed AV Delay of 120ms with BiV pacing was programmed
10797932|NCT03089281|BG002|Baseline|Total|Total of all reporting groups
11196339|NCT02164240|BG000|Baseline|Sunitinib Alternated With Regorafenib|Sunitinib: Intervention Description: 3 days of once daily sunitinib alternating with 4 days of once daily regorafenib throughout each 28 day cycle.
11384184|NCT01787552|BG000|Baseline|LDE225 400mg + INC424 10 mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 10mg in the dose escalation phase.
11384185|NCT01787552|BG001|Baseline|LDE225 400mg + INC424 15 mg (Dose Escalation Phase)|Participants who took a combination of LDED225 400mg and INC424 15mg in the dose escalation phase
11384186|NCT01787552|BG002|Baseline|LDE225 400mg + INC424 20mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 20mg in the dose escalation phase.
11384187|NCT01787552|BG003|Baseline|LDED225 400mg + INC424 20mg (Dose Expansion Phase)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose expansion phase
11384188|NCT01787552|BG004|Baseline|Total|Total of all reporting groups
11384189|NCT01787552|FG000|Participant Flow|LDE225 400mg + INC424 10 mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 10mg in the dose escalation phase.
11384190|NCT01787552|FG001|Participant Flow|LDE225 400mg + INC424 15 mg (Dose Escalation Phase)|Participants who took a combination of LDED225 400mg and INC424 15mg in the dose escalation phase
11384191|NCT01787552|FG002|Participant Flow|LDE225 400mg + INC424 20mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 20mg in the dose escalation phase.
11384192|NCT01787552|FG003|Participant Flow|LDED225 400mg + INC424 20mg (Dose Expansion Phase)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose expansion phase
11384193|NCT01787552|OG000|Outcome|LDE225 400mg + INC424 10mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 10mg in the dose escalation phase.
11384194|NCT01787552|OG001|Outcome|LDE225 400mg + INC424 15mg (Dose Escalation Phase)|Participants who took a combination of LDED225 400mg and INC424 15mg in the dose escalation phase
11384195|NCT01787552|OG002|Outcome|LDE225 400mg + INC424 20mg (Dose Escalation Phase)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose escalation phase
11384196|NCT01787552|OG003|Outcome|LDED225 400mg + INC424 20mg (Dose Expansion Phase)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose expansion phase
11384197|NCT01787552|OG000|Outcome|LDED225 400mg + INC424 20mg (Dose Expansion Phase)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose expansion phase
10797933|NCT03089281|FG000|Participant Flow|SmartDelay™ Algorithm|AV Delay and pacing chamber were determined by SmartDelay algorithm
10797934|NCT03089281|FG001|Participant Flow|Fixed AV Delay With BiV Pacing|Fixed AV Delay of 120ms with BiV pacing was programmed
11196340|NCT02164240|FG000|Participant Flow|Sunitinib 37.5 and Regorafenib 120|Patients were enrolled and treated with sunitinib 37.5mg daily alternating with regorafenib 120mg daily
11384198|NCT01787552|OG002|Outcome|LDE225 400mg + INC424 20mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 20mg in the dose escalation phase.
11384199|NCT01787552|OG001|Outcome|LDE225 400mg + INC424 15mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 15mg in the dose escalation phase.
11384200|NCT01787552|OG000|Outcome|LDE225 400mg + INC424 10 mg (Dose Escalation Phase)|Participants who took a combination of LDE225 400mg and INC424 10mg in the dose escalation phase.
11384201|NCT01787552|EG000|Reported Event|LDE225 400 mg + INC424 10 mg|Participants who took a combination of LDE225 400mg and INC424 10mg in the dose escalation phase
11384202|NCT01787552|EG001|Reported Event|LDE225 400 mg + INC424 15 mg|Participants who took a combination of LDED225 400mg and INC424 15mg in the dose escalation phase
11384203|NCT01787552|EG002|Reported Event|LDE225 400 mg + INC424 20 mg|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose escalation phase
11384204|NCT01787552|EG003|Reported Event|LDE225 400 mg + INC424 20 mg (Dose Expansion)|Participants who took a combination of LDED225 400mg and INC424 20mg in the dose expansion phase
11384205|NCT01787552|EG004|Reported Event|All Patients|All Patients
11384206|NCT01807117|BG000|Baseline|Diagnostic (PET-CT and PET-MRI)|"Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384207|NCT01807117|FG000|Participant Flow|Diagnostic (PET-CT and PET-MRI)|"Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384208|NCT01807117|OG000|Outcome|Blood Pool|"Physiologic region - Diagnostic (PET-CT and PET-MRI) arm~Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384209|NCT01807117|OG001|Outcome|Liver|"Physiologic region - Diagnostic (PET-CT and PET-MRI) arm Physiologic region - Diagnostic (PET-CT and PET-MRI) arm~Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384210|NCT01807117|OG000|Outcome|Diagnostic (PET-CT and PET-MRI)|"Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384211|NCT01807117|EG000|Reported Event|Diagnostic (PET-CT and PET-MRI)|"Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.~positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI~fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI"
11384212|NCT01808261|BG000|Baseline|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384213|NCT01808261|BG001|Baseline|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384214|NCT01808261|BG002|Baseline|Total|Total of all reporting groups
11384215|NCT01808261|FG000|Participant Flow|Placebo|Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384216|NCT01808261|FG001|Participant Flow|GSK249320 15 mg/kg|Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384217|NCT01808261|OG000|Outcome|Placebo|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384218|NCT01808261|OG001|Outcome|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384219|NCT01808261|OG000|Outcome|Placebo - PP|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo - Per Protocol (PP) Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
10797935|NCT03089281|OG000|Outcome|SmartDelay™ Algorithm|AV Delay and pacing chamber were determined by SmartDelay algorithm
11384220|NCT01808261|OG001|Outcome|GSK249320 15 mg/kg - PP|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The GSK249320 15 mg/kg - PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
11384221|NCT01808261|OG000|Outcome|Placebo - PP|Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.
11384222|NCT01808261|OG000|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
11384223|NCT01808261|OG001|Outcome|GSK249320 15 mg/kg - Safety|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
11384224|NCT01808261|OG001|Outcome|GSK249320 15/mg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384225|NCT01808261|OG000|Outcome|Placebo - Safety|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product
11384226|NCT01808261|OG000|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
10797936|NCT03089281|OG001|Outcome|Fixed AV Delay With BiV Pacing|Fixed AV Delay of 120ms with BiV pacing was programmed
10797937|NCT03089281|EG000|Reported Event|SmartDelay™ Algorithm|AV Delay and pacing chamber were determined by SmartDelay algorithm
10797938|NCT03089281|EG001|Reported Event|Fixed AV Delay With BiV Pacing|Fixed AV Delay of 120ms with BiV pacing was programmed
11196341|NCT02164240|FG001|Participant Flow|Sunitinib 37.5 and Regorafenib 160|Patients were enrolled and treated with sunitinib 37.5mg daily alternating with regorafenib 160mg daily
11196342|NCT02164240|FG002|Participant Flow|Expansion Sunitinib 37.5 Regorafenib 120|Patients were enrolled and treated with sunitinib 37.5mg daily alternating with regorafenib 120mg daily
10797939|NCT03085563|BG000|Baseline|Nitrous Oxide|"Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.~Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%."
10797940|NCT03085563|BG001|Baseline|Intranasal Midazolam|"Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.~Midazolam: Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures."
10797941|NCT03085563|BG002|Baseline|Total|Total of all reporting groups
10797942|NCT03085563|FG000|Participant Flow|Nitrous Oxide|"Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.~Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%."
10797943|NCT03085563|FG001|Participant Flow|Intranasal Midazolam|"Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.~Midazolam: Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures."
10797944|NCT03085563|OG000|Outcome|Nitrous Oxide|"Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.~Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%."
10797945|NCT03085563|OG001|Outcome|Intranasal Midazolam|"Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.~Midazolam: Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures."
10797946|NCT03085563|EG000|Reported Event|Nitrous Oxide|"Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.~Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%."
10797947|NCT03085563|EG001|Reported Event|Intranasal Midazolam|"Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.~Midazolam: Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures."
11384227|NCT01808261|OG000|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384228|NCT01808261|OG000|Outcome|GSK249320 15 mg/kg - PK|Participants received GSK249320 15 mg/kg, administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.
11384229|NCT01808261|EG000|Reported Event|Placebo|Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
11384230|NCT01808261|EG001|Reported Event|GSK249320 15 mg/kg|Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
10797948|NCT03084367|BG000|Baseline|Diagnostic Test: iFR Pullback|iFR (instantaneous wave free ratio) pullback assessment post angiographically successful PCI
10797949|NCT03084367|FG000|Participant Flow|All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI|all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
10797950|NCT03084367|OG000|Outcome|All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI|all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
10797951|NCT03084367|OG000|Outcome|iFR >= 0.90|Participants with iFR >= 0.90 post-procedure
10797952|NCT03084367|OG001|Outcome|iFR < 0.90|Participants with iFR < 0.90 post-procedure
10797953|NCT03084367|OG000|Outcome|iFR <= 0.94|post-procedural iFR <= 0.94
10797954|NCT03084367|OG001|Outcome|iFR > 0.94|post-procedural iFR > 0.94
10797955|NCT03084367|OG000|Outcome|Residual Ischemia (Post-PCI iFR <0.90) After Angiographically Successful PCI|Residual ischemia (post-PCI iFR <0.90)
10797956|NCT03084367|EG000|Reported Event|All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI|all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
10803350|NCT00455325|BG000|Baseline|All Randomized Subject|All Randomized Subjects
10803351|NCT00455325|FG000|Participant Flow|Placebo Comparator: First Intervention (3 Weeks)|"Chloroquine placebo one tablet daily for 3 weeks~Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period"
10803352|NCT00455325|FG001|Participant Flow|Second Intervention (3 Weeks)|80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period
10803353|NCT00455325|FG002|Participant Flow|Third Intervention (3 Weeks)|80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
10803354|NCT00455325|FG003|Participant Flow|Fourth Intervention (3 Weeks)|250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
10803355|NCT00455325|OG000|Outcome|Placebo Comparator: First Intervention (3 Weeks)|"Chloroquine placebo one tablet daily for 3 weeks~Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period"
10803356|NCT00455325|OG001|Outcome|Second Intervention (3 Weeks)|80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period
10803357|NCT00455325|OG002|Outcome|Third Intervention (3 Weeks)|80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
10803358|NCT00455325|OG003|Outcome|Fourth Intervention (3 Weeks)|250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
10803359|NCT00455325|OG003|Outcome|Fourth Intervention (3 Weeks)|Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
10803360|NCT00455325|EG000|Reported Event|First Intervention|Placebo Comparator (3 weeks) followed by 5-7 week rest period
10803361|NCT00455325|EG001|Reported Event|Second Intervention|80mg Chloroquine weekly (3 weeks) followed by 5-7 week rest period
10803362|NCT00455325|EG002|Reported Event|Third Intervention|80mg chloroquine daily (3 weeks)followed by 5-7 week rest period
10803363|NCT00455325|EG003|Reported Event|Fourth Intervention|250mg chloroquine tablet daily(3 weeks) followed by 5-7 week rest period
10803364|NCT00321555|BG000|Baseline|LMB-2 to Treat Hairy Cell Leukemia|"LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.~Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin: LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks."
10803365|NCT00321555|FG000|Participant Flow|LMB-2 to Treat Hairy Cell Leukemia|"LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.~Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin: LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks."
10803366|NCT00321555|OG000|Outcome|LMB-2 to Treat Hairy Cell Leukemia|"LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.~Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin: LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks."
10803367|NCT00321555|EG000|Reported Event|LMB-2 to Treat Hairy Cell Leukemia|"LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.~Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin: LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks."
11384231|NCT01814826|BG000|Baseline|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).
11384232|NCT01814826|BG001|Baseline|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384233|NCT01814826|BG002|Baseline|MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 30 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384234|NCT01814826|BG003|Baseline|Total|Total of all reporting groups
11384235|NCT01814826|FG000|Participant Flow|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).
11384236|NCT01814826|FG001|Participant Flow|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384237|NCT01814826|FG002|Participant Flow|MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 30 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384238|NCT01814826|OG000|Outcome|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).
11384239|NCT01814826|OG001|Outcome|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384240|NCT01814826|OG002|Outcome|MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 30 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384241|NCT01814826|OG001|Outcome|MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 30 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384242|NCT01814826|EG000|Reported Event|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).
11384243|NCT01814826|EG001|Reported Event|MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous|MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384244|NCT01814826|EG002|Reported Event|MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous|MLN4924 30 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
11384245|NCT01829711|BG000|Baseline|Moxetumomab Pasudotox 40 µg/kg|Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
11384246|NCT01829711|FG000|Participant Flow|Moxetumomab Pasudotox 40 µg/kg|Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
11384247|NCT01829711|OG000|Outcome|Moxetumomab Pasudotox 40 µg/kg|Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
11384248|NCT01829711|EG000|Reported Event|Moxetumomab Pasudotox 40 µg/kg|Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
11384249|NCT01846273|BG000|Baseline|Ranibizumab 0.5 mg + vPDT|Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)
11241247|NCT02485717|EG000|Reported Event|Natroba (Spinosad)|"spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241248|NCT02485717|EG001|Reported Event|Placebo|"placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.~Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241249|NCT02485717|EG002|Reported Event|PK Natroba (Spinosad)|"open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours~open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours."
11241250|NCT02485834|BG000|Baseline|Randomized Patients|Patients on Arms A and B as detailed in the Participant Flow are summarized.
11241251|NCT02485834|FG000|Participant Flow|Arm A - Surgery, Chemotherapy and Radiation Therapy|Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
11241252|NCT02485834|FG001|Participant Flow|Arm B - Surgery, Chemotherapy and FDG-PET|Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
11241253|NCT02485834|OG000|Outcome|Randomized Patients|Patients on Arms A and B as detailed in the Participant Flow are summarized.
11241254|NCT02485834|EG000|Reported Event|Arm A - Surgery, Chemotherapy and Radiation Therapy|Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
11241255|NCT02485834|EG001|Reported Event|Arm B - Surgery, Chemotherapy and FDG-PET|Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
11241256|NCT02485912|BG000|Baseline|Group 1|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11241257|NCT02485912|BG001|Baseline|Group 2|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11241258|NCT02485912|BG002|Baseline|Total|Total of all reporting groups
11241259|NCT02485912|FG000|Participant Flow|Group 1|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11241260|NCT02485912|FG001|Participant Flow|Group 2|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11241261|NCT02485912|OG000|Outcome|Group 1|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11241262|NCT02485912|OG001|Outcome|Group 2|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
11384250|NCT01846273|BG001|Baseline|Ranibizumab 0.5 mg|Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
11384251|NCT01846273|BG002|Baseline|Ranibizumab 0.5 mg + vPDT (Switched)|Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
11384252|NCT01846273|BG003|Baseline|Total|Total of all reporting groups
11384253|NCT01846273|FG000|Participant Flow|Ranibizumab 0.5 mg + vPDT|Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)
11384254|NCT01846273|FG001|Participant Flow|Ranibizumab 0.5 mg|Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
11384255|NCT01846273|FG002|Participant Flow|Ranibizumab 0.5 mg + vPDT (Switched)|Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
11384256|NCT01846273|OG000|Outcome|Ranibizumab 0.5 mg + vPDT|Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)
11384257|NCT01846273|OG001|Outcome|Ranibizumab 0.5 mg|Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
11384258|NCT01846273|OG002|Outcome|Ranibizumab 0.5 mg + vPDT (Switched)|Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
11384259|NCT01846273|EG000|Reported Event|Ranibizumab 0.5 mg + vPDT|Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)
11384260|NCT01846273|EG001|Reported Event|Ranibizumab 0.5 mg|Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
11384261|NCT01846273|EG002|Reported Event|Ranibizumab 0.5 mg + vPDT (Switched)|Ranibizumab 0.5 mg + vPDT (Switched)
11196343|NCT02164240|OG000|Outcome|Sunitinib 37.5 and Regorafenib 120|Patients were enrolled and treated with sunitinib 37.5 mg daily alternating with regorafenib 120mg daily
11196344|NCT02164240|OG001|Outcome|Sunitinib 37.5 and Regorafenib 160|patients were enrolled and treated with sunitinib 37.5 mg daily and regorafenib 160mg daily
11384262|NCT01875185|BG000|Baseline|Premenopausal|Aspirin 81 mg PO daily x 7 days
11384263|NCT01875185|BG001|Baseline|Postmenopausal|Aspirin 81 mg PO daily x 7 days
11384264|NCT01875185|BG002|Baseline|Total|Total of all reporting groups
11384265|NCT01875185|FG000|Participant Flow|Premenopausal|Aspirin 81 mg PO daily x 7 days
11384266|NCT01875185|FG001|Participant Flow|Postmenopausal|Aspirin 81 mg PO daily x 7 days
11384267|NCT01875185|OG000|Outcome|Premenopausal|premenopausal Women in the cohort
11384268|NCT01875185|OG001|Outcome|Postmenopausal|Postmenopausal Women in the cohort
11384269|NCT01875185|OG000|Outcome|Premenopausal|Aspirin 81 mg PO daily x 7 days
11384270|NCT01875185|OG001|Outcome|Postmenopausal|Aspirin 81 mg PO daily x 7 days
11384271|NCT01875185|OG000|Outcome|Premenopausal|Premenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
11384272|NCT01875185|OG001|Outcome|Postmenopausal|Postmenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
11196345|NCT02164240|OG002|Outcome|Expansion Sunitinib 37.5 Regorafenib 120|RPD2 determined to be sunitinib 37.5mg daily and regorafenib 120mg daily and therefore, per protocol, the cohort was expanded at this dose level
11196346|NCT02164240|OG000|Outcome|Sunitinib and Regorafenib|Patients were enrolled and treated with sunitinib alternating with regorafenib
11384273|NCT01875185|EG000|Reported Event|Premenopausal|Aspirin 81 mg PO daily x 7 days
11384274|NCT01875185|EG001|Reported Event|Postmenopausal|Aspirin 81 mg PO daily x 7 days
11384275|NCT01887743|BG000|Baseline|Normal Weight|BMI10-84th percentile for age
11384276|NCT01887743|BG001|Baseline|Overweight|BMI 85-94th percentile for age
11384277|NCT01887743|BG002|Baseline|Obese|BMI at or above 95th percentile for age
11384278|NCT01887743|BG003|Baseline|Total|Total of all reporting groups
11384279|NCT01887743|FG000|Participant Flow|Obese|BMI for age at or above the 95th percentile
11196347|NCT02164240|EG000|Reported Event|Cohort 1: SuRe120|Patients were enrolled and treated with sunitinib 37.5mg/d alternating with regorafenib 120 mg/d
11196348|NCT02164240|EG001|Reported Event|Cohort 2: SuRe160|Patients were enrolled and treated with sunitinib 37.5mg/d alternating with regorafenib 160 mg/d
11196349|NCT02164240|EG002|Reported Event|Cohort 3: ExpSuRe120|Patients were enrolled and treated with sunitinib 37.5mg/d alternating with regorafenib 120 mg/d
11196350|NCT02164318|BG000|Baseline|Control Group|Standard of care
11196351|NCT02164318|BG001|Baseline|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
11196352|NCT02164318|BG002|Baseline|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
11384280|NCT01887743|FG001|Participant Flow|Overweight|BMI for age 85-94th percentile
11384281|NCT01887743|FG002|Participant Flow|Normal Weight|BMI for age <85th percentile
11384282|NCT01887743|OG000|Outcome|Normal Weight|BMI10-84th percentile for age
11384283|NCT01887743|OG001|Outcome|Overweight|BMI 85-94th percentile for age
11384284|NCT01887743|OG002|Outcome|Obese|BMI at or above 95th percentile for age
11384285|NCT01887743|OG000|Outcome|Breath Test|Children with evaluable breath data and the following CYP2C19 genotypes *1/*1, *1/17 (i.e., extensive metabolizer) and *1/*2 ,*2/*17 (i.e., intermediate metabolizer) were included in the breath test analyses (n=59) to assess how well the test could discriminate CYP2C19 extensive metablizers (EM) from intermediate metabolizers (IM).
11384286|NCT01887743|EG000|Reported Event|Normal Weight|BMI10-84th percentile for age
11384287|NCT01887743|EG001|Reported Event|Overweight|BMI 85-94th percentile for age
11384288|NCT01887743|EG002|Reported Event|Obese|BMI at or above 95th percentile for age
11384289|NCT01891643|BG000|Baseline|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384290|NCT01891643|BG001|Baseline|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384291|NCT01891643|BG002|Baseline|Total|Total of all reporting groups
11384292|NCT01891643|FG000|Participant Flow|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384293|NCT01891643|FG001|Participant Flow|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384294|NCT01891643|OG000|Outcome|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384295|NCT01891643|OG001|Outcome|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384296|NCT01891643|EG000|Reported Event|E-Ld Cohort|Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384297|NCT01891643|EG001|Reported Event|Ld Cohort|Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
11384298|NCT01900691|BG000|Baseline|Evolution® Esophageal Stent|Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
11384299|NCT01900691|FG000|Participant Flow|Evolution® Esophageal Stent|Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
11384300|NCT01900691|OG000|Outcome|Evolution® Esophageal Stent|Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
11384301|NCT01900691|OG000|Outcome|Evolution® Esophageal Stent|Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign fistulas, perforations or leaks with the intention of removal
11384302|NCT01900691|EG000|Reported Event|Evolution® Esophageal Stent|Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
10797957|NCT03082898|BG000|Baseline|AIS A or B Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797958|NCT03082898|BG001|Baseline|AIS C or D Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797959|NCT03082898|BG002|Baseline|Total|Total of all reporting groups
10797960|NCT03082898|FG000|Participant Flow|AIS A or B Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797961|NCT03082898|FG001|Participant Flow|AIS C or D Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797962|NCT03082898|OG000|Outcome|AIS A or B Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797963|NCT03082898|OG001|Outcome|AIS C or D Using Indego Exoskeleton|"Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.~Indego Exoskeleton: Regular dosing of Indego Exoskeleton walking."
10797964|NCT03082898|EG000|Reported Event|AIS A or B Using Indego Exoskeleton|Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of Indego Exoskeleton walking.
10797965|NCT03082898|EG001|Reported Event|AIS C or D Using Indego Exoskeleton|Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of Indego Exoskeleton walking.
10797966|NCT03082313|BG000|Baseline|Movement Intervention|"The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.~Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care."
10797967|NCT03082313|FG000|Participant Flow|Movement Intervention|"The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.~Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care."
11241263|NCT02485912|EG000|Reported Event|Group 1|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
10797968|NCT03082313|OG000|Outcome|Movement Intervention|"The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.~Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care."
10797969|NCT03082313|EG000|Reported Event|Movement Intervention|"The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.~Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care."
10797970|NCT03082391|BG000|Baseline|Heavy Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.~Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh."
11202302|NCT02206828|OG003|Outcome|Ease of Use - Mesh Memory Shape|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202303|NCT02206828|OG004|Outcome|Ease of Use - Minimizing Visceral Attachment Property|Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202304|NCT02206828|OG000|Outcome|Mesh Positioning and Deployment|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202305|NCT02206828|OG000|Outcome|Surgical Approach|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202306|NCT02206828|OG000|Outcome|Operative Time (Min)|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202307|NCT02206828|OG000|Outcome|Hospital Stay ( Days)|Hospital stay for patients treated for ventral hernia (Days)
11202308|NCT02206828|EG000|Reported Event|Symbotex Composite Mesh|Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
11202309|NCT02207088|BG000|Baseline|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
11202310|NCT02207088|FG000|Participant Flow|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
11202311|NCT02207088|OG000|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
11202312|NCT02207088|EG000|Reported Event|3-DAA +/- RBV|3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
11202313|NCT02207231|BG000|Baseline|Placebo Then Guselkumab 100 mg|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.
11202314|NCT02207231|BG001|Baseline|Guselkumab 100 mg|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.
11202315|NCT02207231|BG002|Baseline|Adalimumab Then Guselkumab 100 mg|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
11202316|NCT02207231|BG003|Baseline|Total|Total of all reporting groups
11202317|NCT02207231|FG000|Participant Flow|Placebo Then Guselkumab 100 mg|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.
11202318|NCT02207231|FG001|Participant Flow|Guselkumab 100 mg|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.
11202319|NCT02207231|FG002|Participant Flow|Adalimumab Then Guselkumab 100 mg|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
11202320|NCT02207231|FG003|Participant Flow|Guselkumab Combined|All participants who received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
11202321|NCT02207231|OG000|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
10797971|NCT03082391|BG001|Baseline|Medium Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.~Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.~Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh."
10797972|NCT03082391|BG002|Baseline|Total|Total of all reporting groups
10797973|NCT03082391|FG000|Participant Flow|Heavy Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.~Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh."
10797974|NCT03082391|FG001|Participant Flow|Medium Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.~Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.~Medium weight Mesh: Patients will undergo ventral hernia repair with medium weight mesh."
10797975|NCT03082391|OG000|Outcome|Heavy Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.~Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh."
10797976|NCT03082391|OG001|Outcome|Medium Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.~Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.~Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh."
10797977|NCT03082391|EG000|Reported Event|Heavy Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.~Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh."
10797978|NCT03082391|EG001|Reported Event|Medium Weight Mesh|"Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.~Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.~Medium weight Mesh: Patients will undergo ventral hernia repair with medium weight mesh."
11196353|NCT02164318|BG003|Baseline|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
11196354|NCT02164318|BG004|Baseline|Total|Total of all reporting groups
11196355|NCT02164318|FG000|Participant Flow|Control Group|Standard of care
11196356|NCT02164318|FG001|Participant Flow|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
10797979|NCT03081767|BG000|Baseline|Patients Undergoing Digital PET/CT|Patients referred to Nuclear Medicine undergo imaging on the standard PET/CT and also have imaging performed on the digital PET/CT.
10797980|NCT03081767|FG000|Participant Flow|Patients Undergoing Digital PET/CT|Patients referred to Nuclear Medicine undergo imaging on the standard positron emission tomography/computed tomography (PET/CT) and also have imaging performed on the digital PET/CT.
10797981|NCT03081767|OG000|Outcome|Digital PET/CT|Imaging using digital PET/CT.
10797982|NCT03081767|OG001|Outcome|Standard PET/CT|Imaging using standard PET/CT.
10797983|NCT03081767|EG000|Reported Event|Digital PET/CT|Imaging using digital PET/CT.
10797984|NCT03081767|EG001|Reported Event|Standard PET/CT|Imaging using standard PET/CT.
10797985|NCT03056443|BG000|Baseline|Continuous Positive Airway Pressure-CPAP|"CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.~Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP."
11384303|NCT01901432|BG000|Baseline|Givinostat DL0 (50 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL0 (50 mg twice daily [b.i.d.]). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 50 mg b.i.d. (DL0) was the third DL to be administered."
10797986|NCT03056443|FG000|Participant Flow|Continuous Positive Airway Pressure-CPAP|"CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.~Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP."
10797987|NCT03056443|OG000|Outcome|Continuous Positive Airway Pressure-CPAP|"CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.~Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP."
10797988|NCT03056443|EG000|Reported Event|Continuous Positive Airway Pressure-CPAP|"CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.~Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP."
10797989|NCT03020225|BG000|Baseline|White Cheese|"Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water~White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water"
10797990|NCT03020225|BG001|Baseline|Green Peas|"Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water~Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water"
10797991|NCT03020225|BG002|Baseline|Mankai|"Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water~Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water"
10797992|NCT03020225|BG003|Baseline|Total|Total of all reporting groups
10797993|NCT03020225|FG000|Participant Flow|White Cheese|"Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water~White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water"
10797994|NCT03020225|FG001|Participant Flow|Green Peas|"Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water~Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water"
10797995|NCT03020225|FG002|Participant Flow|Mankai|"Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water~Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water"
10797996|NCT03020225|OG000|Outcome|White Cheese|Essential amino acids (mmol/L)
10797997|NCT03020225|OG001|Outcome|Green Peas|Essential amino acids
10797998|NCT03020225|OG002|Outcome|Mankai|Essential amino acids
10797999|NCT03020225|OG000|Outcome|White Cheese|blood biomarkers of glycemia
10798000|NCT03020225|OG001|Outcome|Green Peas|blood biomarkers of glycemia
10798001|NCT03020225|OG002|Outcome|Mankai|blood biomarkers of glycemia
10798002|NCT03020225|OG000|Outcome|White Cheese|cholesterol fractions
10798003|NCT03020225|OG001|Outcome|Green Peas|cholesterol fractions
10798004|NCT03020225|OG002|Outcome|Mankai|cholesterol fractions
10798005|NCT03020225|OG000|Outcome|Soft Cheese|ALT measured in blood
10798006|NCT03020225|OG001|Outcome|Green Peas|ALT measured in blood
10798007|NCT03020225|OG002|Outcome|Mankai|ALT measured in blood
10798008|NCT03020225|OG000|Outcome|White Cheese|potassium levels
10798009|NCT03020225|OG001|Outcome|Green Peas|potassium levels
10798010|NCT03020225|OG002|Outcome|Mankai|potassium levels
10798011|NCT03020225|OG000|Outcome|White Cheese|Vitamin B12 (blood measures)
10798012|NCT03020225|OG001|Outcome|Green Peas|Vitamin B12 (blood measures)
10798013|NCT03020225|OG002|Outcome|Mankai|Vitamin B12 (blood measures)
10798014|NCT03020225|OG000|Outcome|White Cheese|Triglycerides
10798015|NCT03020225|OG001|Outcome|Green Peas|Triglycerides
10798016|NCT03020225|OG002|Outcome|Mankai|Triglycerides
10798017|NCT03020225|OG000|Outcome|Soft Cheese|ASATmeasured in blood
10798018|NCT03020225|OG001|Outcome|Green Peas|ASATmeasured in blood
10798019|NCT03020225|OG002|Outcome|Mankai|ASAT measured in blood
10798020|NCT03020225|OG000|Outcome|White Cheese|Magnesium levels
10798021|NCT03020225|OG001|Outcome|Green Peas|Magnesium levels
10798022|NCT03020225|OG002|Outcome|Mankai|Magnesium levels
10798023|NCT03020225|EG000|Reported Event|White Cheese|"Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water~White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water"
10798024|NCT03020225|EG001|Reported Event|Green Peas|"Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water~Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water"
10798025|NCT03020225|EG002|Reported Event|Mankai|"Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water~Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water"
10803910|NCT01146652|OG000|Outcome|Sarilumab + DMARD: EFC11072, and ACT11575|Participants who completed any of the initial studies: Part A or Part B of EFC11072, and ACT11575 were enrolled in LTS11210 and received sarilumab 150 mg SC qw. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
10803911|NCT01146652|OG000|Outcome|Sarilumab + DMARD: EFC10832|Participants who completed study EFC10832 were enrolled in LTS11210 and received sarilumab 150 mg SC qw. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
10803912|NCT01146652|EG000|Reported Event|Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD)|Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase [ALT]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking.
11196357|NCT02164318|FG002|Participant Flow|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
10798026|NCT03004586|BG000|Baseline|All Study Participants|Participants had their lymph nodes sampled both with 25-gauge needle first followed by the 22-gauge needle and 22-gauge needle first followed by the 25-gauge needle.
10798027|NCT03004586|FG000|Participant Flow|Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle|Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
10798028|NCT03004586|FG001|Participant Flow|Control Group: First Using a 22-gauge Needle Then 25-gauge Needle|Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
10798029|NCT03004586|OG000|Outcome|Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle|Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
10798030|NCT03004586|OG001|Outcome|Control Group: First Using a 22-gauge Needle Then 25-gauge Needle|Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
10798031|NCT03004586|OG000|Outcome|Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle|Participants lymph nodes were sampled first by two 25-gauge needles then two 22-gauge needles for a total of 4 needles per person.
10798032|NCT03004586|OG001|Outcome|Control Group: First Using a 22-gauge Needle Then 25-gauge Needle|Participants lymph nodes were sampled first by two 22-gauge needles then two 25-gauge needles for a total of 4 needles per person.
10798033|NCT03004586|EG000|Reported Event|Intervention Group: First Using a 25-gauge Needle Then 22 Gauge-needle|Participants lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle and sampled with 22-gauge needle first followed by the 25-gauge needle.
10798034|NCT03004586|EG001|Reported Event|Control Group: First Using a 22-gauge Needle Then 25 -Gauge Needle|Patients in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
10798035|NCT05110014|BG000|Baseline|Primary Care Office Visits - Before mPATH|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798036|NCT05110014|BG001|Baseline|Primary Care Office Visits - After mPATH|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798037|NCT05110014|BG002|Baseline|Total|Total of all reporting groups
10798038|NCT05110014|FG000|Participant Flow|Before mPATH Launch|"The number of participants screened prior to the mPATH intervention.~The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798039|NCT05110014|FG001|Participant Flow|After mPATH Launch|"The number of participants screened after MPATH intervention.~The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10803383|NCT04471935|BG000|Baseline|At Home Speech Hero Therapy|At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
10803384|NCT04471935|FG000|Participant Flow|At Home Speech Hero Therapy|At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
10798040|NCT05110014|OG000|Outcome|Primary Care Practices|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798041|NCT05110014|OG000|Outcome|Primary Care Office Visits|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798042|NCT05110014|OG000|Outcome|Primary Care Office Visits (Pre Intervention)|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798043|NCT05110014|OG001|Outcome|Primary Care Office Visits (Post Intervention)|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798044|NCT05110014|EG000|Reported Event|Primary Care Office Visits (Pre Intervention)|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798045|NCT05110014|EG001|Reported Event|Primary Care Office Visits (Post Intervention)|"The limited use dataset will contain the following data elements for each completed patient visit:~Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date)~Clinic (designated by a unique study clinic identifier)~Type of visit completed (for example, new patient visit, return patient visit, annual exam)~Patient age~Patient gender~Patient race/ethnicity~Patient primary insurance~Nursing staff who roomed the patient (designated by a unique study identifier)~Whether patient used mPATH-CheckIn program (Y/N)~Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N)~Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N)~Whether patient has an antidepressant medication listed in the active medication list ( (Y/N)~Results of depression screening items~Results of fall risk screening items~Results of safety at home screening items~Primary Care Office Visits: mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence"
10798046|NCT04980040|BG000|Baseline|Nesina® Tablet|Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
10798047|NCT04980040|FG000|Participant Flow|Nesina® Tablet|Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
10798048|NCT04980040|OG000|Outcome|Nesina® Tablet|Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
10798049|NCT04980040|EG000|Reported Event|Nesina® Tablet|Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
10803385|NCT04471935|OG000|Outcome|At Home Speech Hero Therapy|At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.
11384304|NCT01901432|BG001|Baseline|Givinostat DL1 (100 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL1 (100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
10803386|NCT04471935|EG000|Reported Event|At Home Speech Hero Therapy|At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
11196358|NCT02164318|FG003|Participant Flow|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
11384305|NCT01901432|BG002|Baseline|Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)|"Following initial assignment of 3 patients to DL1 in Part A, a further 3 patients were assigned to DL1 so this treatment group is referred to as DL1 expanded (patients received givinostat by oral administration at 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384306|NCT01901432|BG003|Baseline|Givinostat DL6 (100 mg + 50 mg) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL6 (100 mg in the morning and 50 mg in the evening, i.e. 12 hours after). Patients were treated for up to 6 cycles in (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg + 50 mg (DL6) was the second DL to be administered."
11384307|NCT01901432|BG004|Baseline|Givinostat at MTD (100 mg b.i.d.) (Part B)|In Part B, patients were assigned to receive the starting dose of givinostat by oral administration at the MTD determined in Part A (i.e. 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle). Based on evaluations performed as part of the visit procedures on Day 28 of each cycle up to Cycle 5 and/or in any necessary additional study visit, the givinostat dose was decreased if appropriate for any patients that met dose reduction criteria.
11384308|NCT01901432|BG005|Baseline|Total Title|
11384309|NCT01901432|FG000|Participant Flow|Givinostat DL0 (50 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at Dose Level 0 (DL0) (50 milligrams [mg] twice daily [b.i.d.]). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 50 mg b.i.d. (DL0) was the third DL to be administered."
11384310|NCT01901432|FG001|Participant Flow|Givinostat DL1 (100 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL1 (100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384311|NCT01901432|FG002|Participant Flow|Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)|"Following initial assignment of 3 patients to DL1 in Part A, a further 3 patients were assigned to DL1 so this treatment group is referred to as DL1 expanded (patients received givinostat by oral administration at 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384312|NCT01901432|FG003|Participant Flow|Givinostat DL6 (100 mg + 50 mg) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL6 (100 mg in the morning and 50 mg in the evening, i.e. 12 hours after). Patients were treated for up to 6 cycles in (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg + 50 mg (DL6) was the second DL to be administered."
11384313|NCT01901432|FG004|Participant Flow|Givinostat at MTD (100 mg b.i.d.) (Part B)|In Part B, patients were assigned to receive the starting dose of givinostat by oral administration at the MTD determined in Part A (i.e. 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle). Based on evaluations performed as part of the visit procedures on Day 28 of each cycle up to Cycle 5 and/or in any necessary additional study visit, the givinostat dose was decreased if appropriate for any patients that met dose reduction criteria.
11196359|NCT02164318|OG000|Outcome|Control Group|Standard of care
11384314|NCT01901432|OG000|Outcome|Givinostat DL0 (50 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL0 (50 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 50 mg b.i.d. (DL0) was the third DL to be administered."
11384315|NCT01901432|OG001|Outcome|Givinostat DL1 (100 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL1 (100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384316|NCT01901432|OG002|Outcome|Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)|"Following initial assignment of 3 patients to DL1 in Part A, a further 3 patients were assigned to DL1 so this treatment group is referred to as DL1 expanded (patients received givinostat by oral administration at 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384317|NCT01901432|OG003|Outcome|Givinostat DL6 (100 mg + 50 mg) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL6 (100 mg in the morning and 50 mg in the evening, i.e. 12 hours after). Patients were treated for up to 6 cycles in (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg + 50 mg (DL6) was the second DL to be administered."
11384318|NCT01901432|OG000|Outcome|Givinostat at MTD (100 mg b.i.d.) (Part B)|In Part B, patients were assigned to receive the starting dose of givinostat by oral administration at the MTD determined in Part A (i.e. 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle). Based on evaluations performed as part of the visit procedures on Day 28 of each cycle up to Cycle 5 and/or in any necessary additional study visit, the givinostat dose was decreased if appropriate for any patients that met dose reduction criteria.
10798050|NCT04218279|BG000|Baseline|Sleep Health Education|"At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798051|NCT04218279|BG001|Baseline|Wait List Control|"At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798052|NCT04218279|BG002|Baseline|Total|Total of all reporting groups
10798053|NCT04218279|FG000|Participant Flow|Sleep Health Education|"At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798054|NCT04218279|FG001|Participant Flow|Wait List Control|"At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798055|NCT04218279|OG000|Outcome|Sleep Health Education|"At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798056|NCT04218279|OG001|Outcome|Wait List Control|"At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798057|NCT04218279|EG000|Reported Event|Sleep Health Education|"At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798058|NCT04218279|EG001|Reported Event|Wait List Control|"At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..~Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website."
10798059|NCT04167670|BG000|Baseline|Vonoprazan Dual Therapy|Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
10798060|NCT04167670|BG001|Baseline|Vonoprazan Triple Therapy|Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798061|NCT04167670|BG002|Baseline|Lansoprazole Triple Therapy|Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798062|NCT04167670|BG003|Baseline|Total|Total of all reporting groups
10798063|NCT04167670|FG000|Participant Flow|Vonoprazan Dual Therapy|Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
10798064|NCT04167670|FG001|Participant Flow|Vonoprazan Triple Therapy|Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798065|NCT04167670|FG002|Participant Flow|Lansoprazole Triple Therapy|Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798066|NCT04167670|OG000|Outcome|Vonoprazan Dual Therapy|Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
11384319|NCT01901432|OG000|Outcome|Givinostat Total (Part A)|This dataset comprised all patients in the ITT analysis set who received givinostat in Part A of the study. It represents the 4 Part A treatment arms and includes patients who received givinostat at DL0 (50 mg b.i.d.), DL1 (100 mg b.i.d. [i.e. including DL1 expanded] and DL6 (100 mg + 50 mg) in Part A.
10798067|NCT04167670|OG001|Outcome|Vonoprazan Triple Therapy|Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798068|NCT04167670|OG002|Outcome|Lansoprazole Triple Therapy|Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798069|NCT04167670|EG000|Reported Event|Vonoprazan Dual Therapy|Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14.
10798070|NCT04167670|EG001|Reported Event|Vonoprazan Triple Therapy|Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798071|NCT04167670|EG002|Reported Event|Lansoprazole Triple Therapy|Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14.
10798072|NCT04076917|BG000|Baseline|BIOMONITOR III|Participants consented and inserted with a BIOMONITOR III
10798073|NCT04076917|FG000|Participant Flow|BIOMONITOR III|Participants consented and inserted with a BIOMONITOR III
11196360|NCT02164318|OG001|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
10798074|NCT04076917|OG000|Outcome|BIOMONITOR III|Participants consented and inserted with a BIOMONITOR III
10798075|NCT04076917|EG000|Reported Event|BIOMONITOR III|Participants consented and inserted with a BIOMONITOR III
10798076|NCT04000009|BG000|Baseline|Pimavanserin|Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
10798077|NCT04000009|FG000|Participant Flow|Pimavanserin|Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
10798078|NCT04000009|OG000|Outcome|Pimavanserin|Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
10798079|NCT04000009|EG000|Reported Event|Pimavanserin|Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
10798080|NCT03988335|BG000|Baseline|RIST4721|This arm was randomized to receive 300 mg of RIST4721 once daily for 28 days.
10798081|NCT03988335|BG001|Baseline|Placebo|This arm was randomized to receive placebo once daily for 28 days.
10798082|NCT03988335|BG002|Baseline|Total|Total of all reporting groups
10798083|NCT03988335|FG000|Participant Flow|RIST4721|Subjects were randomized to receive RIST4721 300 mg oral solution once daily for 28 days.
11196361|NCT02164318|OG002|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
10798084|NCT03988335|FG001|Participant Flow|Placebo|Subjects were randomized to receive Placebo oral solution once daily for 28 days.
10798085|NCT03988335|OG000|Outcome|RIST4721 300 mg|RIST4721 300 mg (mITT Analysis Set)
10798086|NCT03988335|OG001|Outcome|Placebo|Placebo (mITT Analysis Set)
10798087|NCT03988335|EG000|Reported Event|RIST4721 300 mg|All subjects who received at least one dose of RIST4721 300 mg (Safety Analysis Set).
10798088|NCT03988335|EG001|Reported Event|Placebo|All subjects who received at least one dose of Placebo (Safety Analysis Set).
10803403|NCT04180540|BG000|Baseline|Percutaneous Closure|"Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation."
10803404|NCT04180540|BG001|Baseline|Manual Compression|"Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician)."
10803405|NCT04180540|BG002|Baseline|Total|Total of all reporting groups
10803406|NCT04180540|FG000|Participant Flow|Percutaneous Closure|"Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation."
10803407|NCT04180540|FG001|Participant Flow|Manual Compression|"Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician)."
10803408|NCT04180540|OG000|Outcome|Percutaneous Closure|"Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation."
10803409|NCT04180540|OG001|Outcome|Manual Compression|"Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician)."
10803410|NCT04180540|EG000|Reported Event|Percutaneous Closure|"Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation."
10803411|NCT04180540|EG001|Reported Event|Manual Compression|"Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.~Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician)."
11196362|NCT02164318|OG003|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
11196363|NCT02164318|EG000|Reported Event|Control Group|Standard of care
11196364|NCT02164318|EG001|Reported Event|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
11196365|NCT02164318|EG002|Reported Event|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
11196366|NCT02164318|EG003|Reported Event|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
11196367|NCT02164383|BG000|Baseline|Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions~Mobile Games"
10798089|NCT03792737|BG000|Baseline|Investigational Group 1|Spiral PDS Plus
10798090|NCT03792737|BG001|Baseline|Investigational Group 2|Spiral MONOCRYL Plus
10798091|NCT03792737|BG002|Baseline|Control groupEdit|PDS Plus or Monocryl Plus
10798092|NCT03792737|BG003|Baseline|Total|Total of all reporting groups
10798093|NCT03792737|FG000|Participant Flow|Investigational Group 1|Spiral PDS Plus
10798094|NCT03792737|FG001|Participant Flow|Investigational Group 2|Spiral MONOCRYL Plus
10798095|NCT03792737|FG002|Participant Flow|Control groupEdit|PDS Plus or Monocryl Plus
10798096|NCT03792737|OG000|Outcome|Investigational group1|Spiral PDS Plus
10798097|NCT03792737|OG001|Outcome|Investigational group2|Spiral MONOCRYL Plus
10798098|NCT03792737|OG002|Outcome|Control Group|PDS Plus or Monocryl Plus
10798099|NCT03792737|EG000|Reported Event|Investigational Group 1|Spiral PDS Plus
10798100|NCT03792737|EG001|Reported Event|Investigational Group 2|Spiral MONOCRYL Plus
10798101|NCT03792737|EG002|Reported Event|Control groupEdit|PDS Plus or Monocryl Plus
10798102|NCT03674112|BG000|Baseline|A: P+H IV Followed by PH FDC SC|In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
11241264|NCT02485912|EG001|Reported Event|Group 2|"ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.~ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein~MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein"
10798103|NCT03674112|BG001|Baseline|B: PH FDC SC Followed by P+H IV|In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798104|NCT03674112|BG002|Baseline|Total|Total of all reporting groups
10798105|NCT03674112|FG000|Participant Flow|A: P+H IV Followed by PH FDC SC|In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798106|NCT03674112|FG001|Participant Flow|B: PH FDC SC Followed by P+H IV|In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798107|NCT03674112|OG000|Outcome|All Participants|In the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798108|NCT03674112|OG001|Outcome|A: P+H IV Followed by PH FDC SC|In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10803412|NCT03912298|BG000|Baseline|Chronic Pain Patients Undergoing Opioid Taper|Chronic pain patients undergoing opioid taper
10803413|NCT03912298|FG000|Participant Flow|Chronic Pain Patients Undergoing Opioid Taper|Chronic pain patients undergoing an individualized opioid taper to a safer daily dose of opioid for up to one year.
10803414|NCT03912298|OG000|Outcome|Chronic Pain Patients Undergoing Opioid Taper|Chronic pain patients undergoing opioid taper
10803415|NCT03912298|EG000|Reported Event|Chronic Pain Patients Undergoing Opioid Taper|Chronic pain patients undergoing opioid taper
11241265|NCT02485925|BG000|Baseline|THERMOCOOL® SMARTTOUCH™ Family of Catheters|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
11384320|NCT01901432|OG000|Outcome|Givinostat DL0 (50 mg b.i.d.) (Part A PK Analysis Set)|This dataset was used for PK analysis and included the patients who received givinostat at DL0 (50 mg b.i.d.) in Part A of the study and for whom PK data was available for analysis.
11384321|NCT01901432|OG001|Outcome|Givinostat DL1 (100 mg b.i.d.) (Part A PK Analysis Set)|This dataset was used for PK analysis and included the patients who received givinostat at DL1 (100 mg b.i.d. [i.e. including DL1 expanded]) in Part A of the study and for whom PK data was available for analysis.
11241266|NCT02485925|FG000|Participant Flow|THERMOCOOL® SMARTTOUCH™ Family of Catheters|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
11241267|NCT02485925|OG000|Outcome|THERMOCOOL® SMARTTOUCH™ Family of Catheters|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
11241268|NCT02485925|EG000|Reported Event|THERMOCOOL® SMARTTOUCH™ Family of Catheters|Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
11241269|NCT02485964|BG000|Baseline|Blood Draw Only|"One time blood draw at time of consent; No treatment~Blood draw: One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion."
11241270|NCT02485964|FG000|Participant Flow|Blood Draw Only|"One time blood draw at time of consent; No treatment~Blood draw: One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion."
11241271|NCT02485964|OG000|Outcome|Blood Draw Only|"One time blood draw at time of consent; No treatment~Blood draw: One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion."
11241272|NCT02485964|EG000|Reported Event|Blood Draw Only|"One time blood draw at time of consent; No treatment~Blood draw: One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion."
11241273|NCT02486016|BG000|Baseline|Fentanyl TDS|"Each volunteer participates in six procedure days.~Apotex generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour~Apotex generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour~Duragesic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour~Duragesic fentanyl TDS (25 µg/h) with heat at 18 h for one hour~Mylan generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour~Mylan generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour~Two week wash out period between each procedure day."
11241274|NCT02486016|FG000|Participant Flow|Fentanyl TDS|"Each volunteer participates in six procedure days. 1) Apotex generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 2) Apotex generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 3) Duragesic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 4) Duragesic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 5) Mylan generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 6) Mylan generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour~Two week wash out period between each procedure day."
11241275|NCT02486016|OG000|Outcome|Apotex Generic Fentanyl TDS|"Each volunteer participates in two procedure days using the Apotex generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Apotex generic fentanyl TDS: 25 µg/hour"
11241276|NCT02486016|OG001|Outcome|Duragesic Reference Fentanyl TDS|"Each volunteer participates in two procedure days using the Duragesic reference (RLD) fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Duragesic reference fentanyl TDS: 25 µg/hour"
11241277|NCT02486016|OG002|Outcome|Mylan Generic Fentanyl TDS|"Each volunteer participates in two procedure days using the Mylan generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Mylan generic fentanyl TDS: 25 µg/hour"
11241278|NCT02486016|EG000|Reported Event|Apotex Generic Fentanyl TDS|"Each volunteer participates in two procedure days using the Apotex generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Apotex generic fentanyl TDS: 25 µg/hour"
11241279|NCT02486016|EG001|Reported Event|Duragesic Reference Fentanyl TDS|"Each volunteer participates in two procedure days using the Duragesic reference (RLD) fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Duragesic reference fentanyl TDS: 25 µg/hour"
11241280|NCT02486016|EG002|Reported Event|Mylan Generic Fentanyl TDS|"Each volunteer participates in two procedure days using the Mylan generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.~Mylan generic fentanyl TDS: 25 µg/hour"
11241281|NCT02486211|BG000|Baseline|Placebo|"Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Placebo: Placebo comparator"
11384322|NCT01901432|OG002|Outcome|Givinostat DL6 (100 mg + 50 mg) (Part A PK Analysis Set)|This dataset was used for PK analysis and included the patients who received givinostat at DL6 (100 mg in the morning and 50 mg in the evening) in Part A of the study and for whom PK data was available for analysis.
11384323|NCT01901432|OG000|Outcome|Givinostat 100 mg b.i.d. (Part B PK Analysis Set)|This dataset was used for PK analysis and included patients who received givinostat at the MTD (100 mg b.i.d.) in Part B of the study and for whom PK data was available for analysis. This dataset was used for PK analysis after Cycle 1 Day 1 (34 patients) and after Cycle 2 Day 28 (17 patients remaining at this dose).
11384324|NCT01901432|OG001|Outcome|Givinostat 75 mg b.i.d. (Part B PK Analysis Set)|This dataset was used for PK analysis and included patients who received givinostat at the reduced dose of 75 mg b.i.d. in Part B of the study and for whom PK data was available for analysis. This dataset only applied for PK analysis from Cycle 2 onwards (i.e. Cycle 2 Day 28).
11384325|NCT01901432|OG002|Outcome|Givinostat 50 mg b.i.d. (Part B PK Analysis Set)|This dataset was used for PK analysis and included patients who received givinostat at the reduced dose of 50 mg b.i.d. in Part B of the study and for whom PK data was available for analysis. This dataset only applied for PK analysis from Cycle 2 onwards (i.e. Cycle 2 Day 28).
11384326|NCT01901432|EG000|Reported Event|Givinostat DL0 (50 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL0 (50 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 50 mg b.i.d. (DL0) was the third DL to be administered."
11384327|NCT01901432|EG001|Reported Event|Givinostat DL1 (100 mg b.i.d.) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL1 (100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384328|NCT01901432|EG002|Reported Event|Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)|"Following initial assignment of 3 patients to DL1 in Part A, a further 3 patients were assigned to DL1 so this treatment group is referred to as DL1 expanded (patients received givinostat by oral administration at 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg b.i.d. (DL1) was the initial DL to be administered."
11384329|NCT01901432|EG003|Reported Event|Givinostat DL6 (100 mg + 50 mg) (Part A)|"In Part A, 3 patients were assigned to receive givinostat by oral administration at DL6 (100 mg in the morning and 50 mg in the evening, i.e. 12 hours after). Patients were treated for up to 6 cycles in (28 days in each cycle).~There were 3 DLs used during Part A; 100 mg + 50 mg (DL6) was the second DL to be administered."
11384330|NCT01901432|EG004|Reported Event|Givinostat at MTD (100 mg b.i.d.) (Part B)|In Part B, patients were assigned to receive the starting dose of givinostat by oral administration at the MTD determined in Part A (i.e. 100 mg b.i.d.). Patients were treated for up to 6 cycles (28 days in each cycle). Based on evaluations performed as part of the visit procedures on Day 28 of each cycle up to Cycle 5 and/or in any necessary additional study visit, the givinostat dose was decreased if appropriate for any patients that met dose reduction criteria.
10965780|NCT00883779|EG001|Reported Event|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
10965781|NCT00884039|BG000|Baseline|30 mg Anecortave Acetate|
10965782|NCT00884039|BG001|Baseline|15 mg Anecortave Acetate|
10965783|NCT00884039|BG002|Baseline|Total|Total of all reporting groups
10965784|NCT00884039|FG000|Participant Flow|30 mg Anecortave Acetate|
10965785|NCT00884039|FG001|Participant Flow|15 mg Anecortave Acetate|
10965786|NCT00884039|OG000|Outcome|30 mg Anecortave Acetate|
10965787|NCT00884039|OG001|Outcome|15 mg Anecortave Acetate|
10965788|NCT00884039|EG000|Reported Event|30 mg Anecortave Acetate|
10965789|NCT00884039|EG001|Reported Event|15 mg Anecortave Acetate|
10965790|NCT00884052|BG000|Baseline|Levetiracetam Dose Escalation|"Escalation of dose after 6 patients treated to 40 mg/kg IV load and 10mg/kg/day maintenance~levetiracetam : 20 mg/kg loading dose; 5 mg/kg daily for 7 days.~levetiracetam : 40 mg/kg IV load; 10 mg/kg/day maintenance"
10965791|NCT00884052|FG000|Participant Flow|Levetiracetam Low Dose|Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6
10965792|NCT00884052|FG001|Participant Flow|Levetiracetam High Dose|Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12
10965793|NCT00884052|OG000|Outcome|All Participants|Participants in both low dose and high dose arms are reported together
10965794|NCT00884052|OG000|Outcome|Levetiracetam Low Dose|"6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily~levetiracetam: 20 mg/kg loading dose; 5 mg/kg daily for 7 days."
10965795|NCT00884052|OG001|Outcome|Levetiracetam High Dose|12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
10965796|NCT00884052|EG000|Reported Event|All Participants|There were two arms (1) Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6 and (2) Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12, however the data collected regarding adverse events was not recorded according to group, so all participants are reported together.
10965797|NCT00884065|BG000|Baseline|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
10965798|NCT00884065|BG001|Baseline|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
10803416|NCT04551677|BG000|Baseline|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10965799|NCT00884065|BG002|Baseline|Total|Total of all reporting groups
10965800|NCT00884065|FG000|Participant Flow|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
11384331|NCT01904279|BG000|Baseline|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
11384332|NCT01904279|BG001|Baseline|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
11384333|NCT01904279|BG002|Baseline|Total|Total of all reporting groups
11384334|NCT01904279|FG000|Participant Flow|TCZ SC 162 mg Q3W|Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
11384335|NCT01904279|FG001|Participant Flow|TCZ SC 162 mg Q2W|Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
11384336|NCT01904279|OG000|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
11384337|NCT01904279|OG001|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
11384338|NCT01904279|OG001|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
11384339|NCT01904279|EG000|Reported Event|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
11384340|NCT01904279|EG001|Reported Event|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
11196368|NCT02164383|BG001|Baseline|No Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention:~Nicotine patch plus behavioral cessation counseling without access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions"
11196369|NCT02164383|BG002|Baseline|Total|Total of all reporting groups
10798109|NCT03674112|OG002|Outcome|B: PH FDC SC Followed by P+H IV|In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798110|NCT03674112|OG000|Outcome|All Participants: TASQ-IV Completers|This analysis set includes all participants from Arms A and B who completed the TASQ-IV questionnaire, which was administered at the last IV treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798111|NCT03674112|OG001|Outcome|All Participants: TASQ-SC Completers|This analysis set includes all participants from Arms A and B who completed the TASQ-SC questionnaire, which was administered at the last SC treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798112|NCT03674112|OG000|Outcome|A: P+H IV Followed by PH FDC SC|In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798113|NCT03674112|OG001|Outcome|B: PH FDC SC Followed by P+H IV|In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
10798114|NCT03674112|OG000|Outcome|All Healthcare Professionals|This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
11196370|NCT02164383|FG000|Participant Flow|Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions~Mobile Games"
11196371|NCT02164383|FG001|Participant Flow|No Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention:~Nicotine patch plus behavioral cessation counseling without access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions"
11196372|NCT02164383|OG000|Outcome|Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions~Mobile Games"
10798115|NCT03674112|OG000|Outcome|Arm A: Treatment With P+H IV (Cycles 1 to 3)|This safety analysis population only includes the adverse events that occurred in Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
10798116|NCT03674112|OG001|Outcome|Arm A: Treatment With PH FDC SC (Cycles 4 to 6)|This safety analysis population only includes adverse events that occurred in Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
10798117|NCT03674112|OG002|Outcome|Arm B: Treatment With PH FDC SC (Cycles 1 to 3)|This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
10798118|NCT03674112|OG003|Outcome|Arm B: Treatment With P+H IV (Cycles 4 to 6)|This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
10798119|NCT03674112|OG000|Outcome|P+H IV: Treatment Cross-Over Period|This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.
10798120|NCT03674112|OG001|Outcome|PH FDC SC: Treatment Cross-Over Period|This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Cross-Over Period of the study.
10798121|NCT03674112|OG002|Outcome|P+H IV: Treatment Continuation Period|This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
10798122|NCT03674112|OG003|Outcome|PH FDC SC: Treatment Continuation Period|This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
11241282|NCT02486211|BG001|Baseline|Amantadine|"100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Amantadine: 100mg BID for 7 days at 0600 and 1200"
10798123|NCT03674112|OG000|Outcome|Arm A: Treatment With P+H IV (Cycles 1 to 3)|This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
10965801|NCT00884065|FG001|Participant Flow|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
10798124|NCT03674112|OG001|Outcome|Arm A: Treatment With PH FDC SC (Cycles 4 to 6)|This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
11241283|NCT02486211|BG002|Baseline|Total|Total of all reporting groups
10798125|NCT03674112|OG002|Outcome|Arm B: Treatment With PH FDC SC (Cycles 1 to 3)|This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
10798126|NCT03674112|OG003|Outcome|Arm B: Treatment With P+H IV (Cycles 4 to 6)|This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
10798127|NCT03674112|EG000|Reported Event|P+H IV: Treatment Cross-Over Period|This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.
10798128|NCT03674112|EG001|Reported Event|PH FDC SC: Treatment Cross-Over Period|This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Cross-Over Period of the study.
11241284|NCT02486211|FG000|Participant Flow|Amantadine|"100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Amantadine: 100mg twice per day for 7 days at 0600 and 1200"
10798129|NCT03674112|EG002|Reported Event|P+H IV: Treatment Continuation Period|This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
10798130|NCT03674112|EG003|Reported Event|PH FDC SC: Treatment Continuation Period|This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
10798131|NCT03618641|BG000|Baseline|Nivolumab and CMP-001 Combination|"Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7.~Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year."
10798132|NCT03618641|FG000|Participant Flow|Nivolumab and CMP-001 Combination|"Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7.~Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year."
10798133|NCT03618641|OG000|Outcome|Nivolumab and CMP-001 Combination|"Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7.~Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year."
10798134|NCT03618641|EG000|Reported Event|Nivolumab and CMP-001 Combination|"Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7.~Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year."
10798135|NCT03584464|BG000|Baseline|Bifurcation Cohort|"Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.~Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting."
10798136|NCT03584464|FG000|Participant Flow|Bifurcation Cohort|"Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.~Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm"
10798137|NCT03584464|OG000|Outcome|Bifurcation Cohort|"Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.~Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm"
11241285|NCT02486211|FG001|Participant Flow|Placebo|"Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Placebo: Placebo comparator"
10798138|NCT03584464|EG000|Reported Event|Bifurcation Cohort|"Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.~Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm"
10798139|NCT03441477|BG000|Baseline|NIDEK TONOREF III Comparison|Adults, 18 years old or older, were enrolled in this study. Participants were measured by the NIDEK TONOREF III and the Haag-Streit GAT and the NIDEK CEM-530, or the NIDEK TONOREF III and the NIDEK CEM-530.
10798140|NCT03441477|FG000|Participant Flow|NIDEK TONOREF III Comparison|Adults, 18 years old or older, were enrolled in this study. Participants were measured by the NIDEK TONOREF III and the Haag-Streit GAT and the NIDEK CEM-530, or the NIDEK TONOREF III and the NIDEK CEM-530.
10798141|NCT03441477|OG000|Outcome|NIDEK TONOREF III Comparison|IOP value were compared between NIDEK TONOREF III and Haag-Streit GAT
10798142|NCT03441477|OG000|Outcome|NIDEK TONOREFIII Comparison|CCT were compared between NIDEK TONOREF III and NIDEK CEM-530.
10798143|NCT03441477|OG000|Outcome|NIDEK TONOREF III Comparison|Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
10798144|NCT03441477|EG000|Reported Event|NIDEK TONOREF III Comparison|Adverse Events were monitored irrespective of specific device and therefore cannot be separated.
10798145|NCT03205371|BG000|Baseline|South Korea(Group1):MenACYW Conjugate +MMR+ Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798146|NCT03205371|BG001|Baseline|South Korea (Group 2): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798147|NCT03205371|BG002|Baseline|South Korea (Group 3): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798148|NCT03205371|BG003|Baseline|Thailand (Group 10): MenACYW Conjugate + MMR+Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798149|NCT03205371|BG004|Baseline|Thailand (Group 11): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798150|NCT03205371|BG005|Baseline|Thailand (Group 12): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798151|NCT03205371|BG006|Baseline|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
10798152|NCT03205371|BG007|Baseline|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798153|NCT03205371|BG008|Baseline|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
10798154|NCT03205371|BG009|Baseline|Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0.
10798155|NCT03205371|BG010|Baseline|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798156|NCT03205371|BG011|Baseline|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
10798157|NCT03205371|BG012|Baseline|Total|Total of all reporting groups
10798158|NCT03205371|FG000|Participant Flow|South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella (MMR) vaccine, and varicella vaccine on Day 0.
10798159|NCT03205371|FG001|Participant Flow|South Korea (Group 2): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798160|NCT03205371|FG002|Participant Flow|South Korea (Group 3): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798161|NCT03205371|FG003|Participant Flow|Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798162|NCT03205371|FG004|Participant Flow|Thailand (Group 11): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798163|NCT03205371|FG005|Participant Flow|Thailand (Group 12): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798164|NCT03205371|FG006|Participant Flow|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
10798165|NCT03205371|FG007|Participant Flow|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798166|NCT03205371|FG008|Participant Flow|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
10798167|NCT03205371|FG009|Participant Flow|Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.
10798168|NCT03205371|FG010|Participant Flow|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798169|NCT03205371|FG011|Participant Flow|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
10798170|NCT03205371|OG000|Outcome|Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798171|NCT03205371|OG001|Outcome|Groups 2 and 11: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine on Day 0.
10798172|NCT03205371|OG002|Outcome|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
10798173|NCT03205371|OG003|Outcome|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798174|NCT03205371|OG004|Outcome|Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
10798175|NCT03205371|OG005|Outcome|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798176|NCT03205371|OG000|Outcome|Groups 1and 10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798177|NCT03205371|OG000|Outcome|Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798178|NCT03205371|OG004|Outcome|Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and PCV13 vaccine on Day 0.
10798179|NCT03205371|OG001|Outcome|Groups 3 and 12: MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MMR vaccine and varicella vaccine on Day 0.
10798180|NCT03205371|OG000|Outcome|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
10798181|NCT03205371|OG001|Outcome|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
10798182|NCT03205371|OG000|Outcome|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate and DTaP-IPV-HB-Hib vaccine on Day 0.
10798183|NCT03205371|OG000|Outcome|Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
10798184|NCT03205371|OG001|Outcome|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
10798185|NCT03205371|OG000|Outcome|South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798186|NCT03205371|OG001|Outcome|South Korea (Group 2): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798187|NCT03205371|OG002|Outcome|South Korea (Group 3): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798188|NCT03205371|OG003|Outcome|Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798189|NCT03205371|OG004|Outcome|Thailand (Group 11): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798190|NCT03205371|OG005|Outcome|Thailand (Group 12): MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798191|NCT03205371|OG001|Outcome|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798192|NCT03205371|OG002|Outcome|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
10798193|NCT03205371|OG001|Outcome|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798194|NCT03205371|OG002|Outcome|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 Vaccine on Day 0.
11196373|NCT02164383|OG001|Outcome|No Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention:~Nicotine patch plus behavioral cessation counseling without access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions"
10798195|NCT03205371|OG005|Outcome|Thailand (Group 12): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798196|NCT03205371|OG006|Outcome|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
10798197|NCT03205371|OG007|Outcome|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798198|NCT03205371|OG008|Outcome|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
10798199|NCT03205371|OG009|Outcome|Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.
10798200|NCT03205371|OG010|Outcome|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798201|NCT03205371|OG011|Outcome|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
10798202|NCT03205371|EG000|Reported Event|South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798203|NCT03205371|EG001|Reported Event|South Korea (Group 2): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798204|NCT03205371|EG002|Reported Event|South Korea (Group 3): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10965802|NCT00884065|OG000|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
10965803|NCT00884065|OG001|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
10798205|NCT03205371|EG003|Reported Event|Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
10798206|NCT03205371|EG004|Reported Event|Thailand (Group 11): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798207|NCT03205371|EG005|Reported Event|Thailand (Group 12): MMR + Varicella Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
10798208|NCT03205371|EG006|Reported Event|Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.
11241286|NCT02486211|OG000|Outcome|Amantadine|"100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Amantadine: 100mg twice per day for 7 days at 0600 and 1200"
10798209|NCT03205371|EG007|Reported Event|Mexico (Group 5): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798210|NCT03205371|EG008|Reported Event|Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
10798211|NCT03205371|EG009|Reported Event|Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and PCV13 Vaccine on Day 0.
10798212|NCT03205371|EG010|Reported Event|Russian Federation (Group 8): MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
10798213|NCT03205371|EG011|Reported Event|Russian Federation (Group 9): PCV13 Vaccine|Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 Vaccine on Day 0.
10798214|NCT03165721|BG000|Baseline|Patients ≥ 12 Years of Age w/Wild-Type GIST|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Gastrointestinal stromal tumor (GIST)~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798215|NCT03165721|BG001|Baseline|Patients ≥ 12 Years of Age w/PHEO/PGL With SDH-deficient PHE|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798216|NCT03165721|BG002|Baseline|Patients ≥ 12 Years of Age w/HLRCC-associated Renal Cell Ca|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798217|NCT03165721|BG003|Baseline|Total|Total of all reporting groups
10798218|NCT03165721|FG000|Participant Flow|Patients ≥ 12 Years of Age w/Wild-Type GIST|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Gastrointestinal stromal tumor (GIST)~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798219|NCT03165721|FG001|Participant Flow|Patients ≥ 12 Years of Age w/PHEO/PGL With SDH-deficient PHE|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798220|NCT03165721|FG002|Participant Flow|Patients ≥ 12 Years of Age w/HLRCC-associated Renal Cell Ca|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798221|NCT03165721|OG000|Outcome|Patients ≥ 12 Years of Age w/Wild-Type GIST|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Gastrointestinal stromal tumor (GIST)~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
11241287|NCT02486211|OG001|Outcome|Placebo|"Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Placebo: Placebo comparator"
10798222|NCT03165721|OG001|Outcome|Patients ≥ 12 Years of Age w/PHEO/PGL With SDH-deficient PHE|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798223|NCT03165721|OG002|Outcome|Patients ≥ 12 Years of Age w/HLRCC-associated Renal Cell Ca|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10803417|NCT04551677|BG001|Baseline|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years|Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10965804|NCT00884065|EG000|Reported Event|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
11241288|NCT02486211|OG000|Outcome|Amantadine|"100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Amantadine: 100mg BID for 7 days at 0600 and 1200"
11241289|NCT02486211|EG000|Reported Event|Amantadine|"100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Amantadine: 100mg BID for 7 days at 0600 and 1200"
10798224|NCT03165721|OG000|Outcome|Patients≥12 Years of Age w/Wild-Type GIST, SDH-deficient PHEO/PGL, or HLRCC-associated Renal Cell Ca|"Gastrointestinal stromal tumor (GIST); Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE; or Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca~SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798225|NCT03165721|OG000|Outcome|Patients≥12 Years of Age w/Wild-Type GIST, SDH-deficient PHEO/PGL, or HLRCC-associated Renal Cell Ca|Gastrointestinal stromal tumor (GIST); Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE; or Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction.
10798226|NCT03165721|EG000|Reported Event|Patients ≥ 12 Years of Age w/Wild-Type GIST|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Gastrointestinal stromal tumor (GIST)~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798227|NCT03165721|EG001|Reported Event|Patients ≥ 12 Years of Age w/PHEO/PGL With SDH-deficient PHE|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Pheochromocytoma and Paraganglioma (PHEO/PGL) with succinate dehydrogenase (SDH)-deficient PHE~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798228|NCT03165721|EG002|Reported Event|Patients ≥ 12 Years of Age w/HLRCC-associated Renal Cell Ca|"SGI-110 administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle~Hereditary leiomyomatosis and renal cell carcinoma (HLRCC)-associated Renal Cell Ca~SGI-110 (guadecitabine): SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction."
10798229|NCT03130959|BG000|Baseline|Arm A1|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798230|NCT03130959|BG001|Baseline|Arm B1|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798231|NCT03130959|BG002|Baseline|Arm A2|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798232|NCT03130959|BG003|Baseline|Arm B2|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798233|NCT03130959|BG004|Baseline|Arm A3|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798234|NCT03130959|BG005|Baseline|Arm B3|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798235|NCT03130959|BG006|Baseline|Arm A4|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 4: participants with relapsed or resistant ependymoma."
10798236|NCT03130959|BG007|Baseline|Arm B4|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 4: participants with relapsed or resistant ependymoma."
10798237|NCT03130959|BG008|Baseline|Arm A5|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798238|NCT03130959|BG009|Baseline|Arm B5|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798239|NCT03130959|BG010|Baseline|Total|Total of all reporting groups
10798240|NCT03130959|FG000|Participant Flow|Arm A1|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798241|NCT03130959|FG001|Participant Flow|Arm B1|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798242|NCT03130959|FG002|Participant Flow|Arm A2|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798243|NCT03130959|FG003|Participant Flow|Arm B2|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798244|NCT03130959|FG004|Participant Flow|Arm A3|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798245|NCT03130959|FG005|Participant Flow|Arm B3|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798246|NCT03130959|FG006|Participant Flow|Arm A4|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 4: participants with relapsed or resistant ependymoma."
11384341|NCT01917318|BG000|Baseline|Iloperidone / Placebo|"During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384342|NCT01917318|BG001|Baseline|Placebo / Iloperidone|"During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384343|NCT01917318|BG002|Baseline|Total|Total of all reporting groups
11384344|NCT01917318|FG000|Participant Flow|Iloperidone / Placebo|"During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384345|NCT01917318|FG001|Participant Flow|Placebo / Iloperidone|"During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384346|NCT01917318|OG000|Outcome|Iloperidone / Placebo|"During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384347|NCT01917318|OG001|Outcome|Placebo / Iloperidone|"During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384348|NCT01917318|EG000|Reported Event|Iloperidone / Placebo|"During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
11384349|NCT01917318|EG001|Reported Event|Placebo / Iloperidone|"During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.~Iloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)~Placebo: During 8 weeks subjects will receive oral placebo"
10798247|NCT03130959|FG007|Participant Flow|Arm B4|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 4: participants with relapsed or resistant ependymoma."
10798248|NCT03130959|FG008|Participant Flow|Arm A5|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10965805|NCT00884065|EG001|Reported Event|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
11196374|NCT02164383|EG000|Reported Event|Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions~Mobile Games"
11241290|NCT02486211|EG001|Reported Event|Placebo|"Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.~Placebo: Placebo comparator"
11384350|NCT01921218|BG000|Baseline|Belatacept Treatment Group|Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
11384351|NCT01921218|BG001|Baseline|Control Group|Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
11384352|NCT01921218|BG002|Baseline|Total|Total of all reporting groups
11384353|NCT01921218|FG000|Participant Flow|Belatacept Treatment Group|Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
11384354|NCT01921218|FG001|Participant Flow|Control Group|Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
11196375|NCT02164383|EG001|Reported Event|No Mobile Games|"This arm of the project will address the following question:~How effective is the following intervention:~Nicotine patch plus behavioral cessation counseling without access to Mobile Games.~Nicotine patch: 4-week starter kit of nicotine patch~Cessation Counseling: 5 brief counseling sessions"
11196376|NCT02164396|BG000|Baseline|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
11196377|NCT02164396|BG001|Baseline|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
11196378|NCT02164396|BG002|Baseline|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
11196379|NCT02164396|BG003|Baseline|Total|Total of all reporting groups
11196380|NCT02164396|FG000|Participant Flow|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
11196381|NCT02164396|FG001|Participant Flow|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
11196382|NCT02164396|FG002|Participant Flow|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
11196383|NCT02164396|OG000|Outcome|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
11196384|NCT02164396|OG001|Outcome|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
11196385|NCT02164396|OG002|Outcome|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
11196386|NCT02164396|EG000|Reported Event|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
10803418|NCT04551677|BG002|Baseline|Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years|Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
11196387|NCT02164396|EG001|Reported Event|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
11196388|NCT02164396|EG002|Reported Event|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
11196389|NCT02164422|BG000|Baseline|Guanfacine 3mg/Day|"Guanfacine 3mg/day~Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196390|NCT02164422|BG001|Baseline|Guanfacine 1.5mg/Day|"Guanfacine 1.5mg/day~Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196391|NCT02164422|BG002|Baseline|Placebo|"Placebo~Placebo"
11196392|NCT02164422|BG003|Baseline|Total|Total of all reporting groups
11196393|NCT02164422|FG000|Participant Flow|Guanfacine 3mg/Day|"Guanfacine 3mg/day~Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196394|NCT02164422|FG001|Participant Flow|Guanfacine 1.5mg/Day|"Guanfacine 1.5mg/day~Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196395|NCT02164422|FG002|Participant Flow|Placebo|"Placebo~Placebo"
11196396|NCT02164422|OG000|Outcome|Guanfacine 3mg/Day|"Guanfacine 3mg/day~Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196397|NCT02164422|OG001|Outcome|Guanfacine 1.5mg/Day|"Guanfacine 1.5mg/day~Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196398|NCT02164422|OG002|Outcome|Placebo|"Placebo~Placebo"
11196399|NCT02164422|EG000|Reported Event|Guanfacine 3mg/Day|"Guanfacine 3mg/day~Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196400|NCT02164422|EG001|Reported Event|Guanfacine 1.5mg/Day|"Guanfacine 1.5mg/day~Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper."
11196401|NCT02164422|EG002|Reported Event|Placebo|"Placebo~Placebo"
11196402|NCT02164513|BG000|Baseline|FF/UMEC/VI|The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.
11196403|NCT02164513|BG001|Baseline|FF/VI|The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
10798249|NCT03130959|FG009|Participant Flow|Arm B5|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798250|NCT03130959|OG000|Outcome|Arm A1, Safety Lead-in|Module A, Cohort 1
10798251|NCT03130959|OG001|Outcome|Arms A2-A5, Safety Lead-in|Module A, Cohorts 2 through 5
10798252|NCT03130959|OG002|Outcome|Arms B2-B5, Safety Lead-in|Module B, Cohorts 2 through 5
10798253|NCT03130959|OG000|Outcome|Arm A1|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798254|NCT03130959|OG001|Outcome|Arm B1|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798255|NCT03130959|OG000|Outcome|Arm A2|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798256|NCT03130959|OG001|Outcome|Arm B2|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798257|NCT03130959|OG002|Outcome|Arm A3|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798258|NCT03130959|OG003|Outcome|Arm B3|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798259|NCT03130959|OG004|Outcome|Arm A4|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 4: participants with relapsed or resistant ependymoma."
10798260|NCT03130959|OG005|Outcome|Arm B4|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 4: participants with relapsed or resistant ependymoma."
11196404|NCT02164513|BG002|Baseline|UMEC/VI|The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
11196405|NCT02164513|BG003|Baseline|Total|Total of all reporting groups
11196406|NCT02164513|FG000|Participant Flow|FF/UMEC/VI|The eligible participants in this arm received Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) as a fixed dose combination (FDC) as 100 microgram (µcg)/62.5µcg/25µcg once daily (QD) via a dry powder inhaler (DPI), in the morning, for duration of 52 weeks.
10798261|NCT03130959|OG000|Outcome|Arm A5|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798262|NCT03130959|OG001|Outcome|Arm B5|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798263|NCT03130959|OG002|Outcome|Arm A2|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798264|NCT03130959|OG003|Outcome|Arm B2|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798265|NCT03130959|OG004|Outcome|Arm A3|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798266|NCT03130959|OG005|Outcome|Arm B3|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798267|NCT03130959|OG006|Outcome|Arm A4|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 4: participants with relapsed or resistant ependymoma."
10798268|NCT03130959|OG007|Outcome|Arm B4|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 4: participants with relapsed or resistant ependymoma."
10798269|NCT03130959|OG006|Outcome|Arm A5|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798270|NCT03130959|OG007|Outcome|Arm B5|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798271|NCT03130959|OG008|Outcome|Arm A5|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798272|NCT03130959|OG009|Outcome|Arm B5|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798273|NCT03130959|EG000|Reported Event|Cohort 1, Module A|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
10798274|NCT03130959|EG001|Reported Event|Cohort 1, Module B|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation."
11196407|NCT02164513|FG001|Participant Flow|FF/VI|The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
11196408|NCT02164513|FG002|Participant Flow|UMEC/VI|The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
11196409|NCT02164513|OG000|Outcome|FF/UMEC/VI|The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.
11196410|NCT02164513|OG001|Outcome|FF/VI|The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
11196411|NCT02164513|OG002|Outcome|UMEC/VI|The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
10798275|NCT03130959|EG002|Reported Event|Cohort 2, Module A|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798276|NCT03130959|EG003|Reported Event|Cohort 2, Module B|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma."
10798277|NCT03130959|EG004|Reported Event|Cohort 3, Module A|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798278|NCT03130959|EG005|Reported Event|Cohort 3, Module B|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 3: participants with relapsed or resistant medulloblastoma."
10798279|NCT03130959|EG006|Reported Event|Cohort 4, Module A|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 4: participants with relapsed or resistant ependymoma."
10798280|NCT03130959|EG007|Reported Event|Cohort 4, Module B|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 4: participants with relapsed or resistant ependymoma."
10798281|NCT03130959|EG008|Reported Event|Cohort 5, Module A|"Module A: nivolumab 3 mg/kg every 2 weeks.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798282|NCT03130959|EG009|Reported Event|Cohort 5, Module B|"Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.~Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others)."
10798283|NCT02955797|BG000|Baseline|Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798284|NCT02955797|BG001|Baseline|Group 2 (Meningococcal Vaccine-Naive): Nimenrix®|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10798285|NCT02955797|BG002|Baseline|Group 3 (MenC-Primed): MenACYW Conjugate Vaccine|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798286|NCT02955797|BG003|Baseline|Group 4 (MenC-Primed): Nimenrix®|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
11196412|NCT02164513|OG001|Outcome|UMEC/VI|The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
10798287|NCT02955797|BG004|Baseline|Total|Total of all reporting groups
10798288|NCT02955797|FG000|Participant Flow|Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
10798289|NCT02955797|FG001|Participant Flow|Group 2 (Meningococcal Vaccine-Naive): Nimenrix®|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine on Day 0.
10798290|NCT02955797|FG002|Participant Flow|Group 3 (MenC-Primed) MenACYW Conjugate Vaccine|Healthy, meningococcal C (MenC) vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798291|NCT02955797|FG003|Participant Flow|Group 4 (MenC-Primed): Nimenrix®|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10798292|NCT02955797|OG000|Outcome|MenACYW Conjugate Vaccine (Groups 1 and 3)|All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
10798293|NCT02955797|OG001|Outcome|Nimenrix® (Groups 2 and 4)|All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
11196413|NCT02164513|EG000|Reported Event|FF/UMEC/VI 100/62.5/25|The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.
11196414|NCT02164513|EG001|Reported Event|FF/VI 100/25|The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
11196415|NCT02164513|EG002|Reported Event|UMEC/VI 62.5/25|The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
10798294|NCT02955797|OG000|Outcome|Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798295|NCT02955797|OG001|Outcome|Group 2 (Meningococcal Vaccine-Naive): Nimenrix®|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10798296|NCT02955797|OG001|Outcome|Nimenrix® (Groups 2 and 4)|All meningococcal vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
10798297|NCT02955797|OG000|Outcome|Group 3 (MenC-Primed): MenACYW Conjugate Vaccine|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798298|NCT02955797|OG001|Outcome|Group 4 (MenC-Primed): Nimenrix®|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10798299|NCT02955797|EG000|Reported Event|Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798300|NCT02955797|EG001|Reported Event|Group 2 (Meningococcal Vaccine-Naive): Nimenrix®|Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10803419|NCT04551677|BG003|Baseline|Total|Total of all reporting groups
11196416|NCT02164539|BG000|Baseline|FF 100 µg|Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11384355|NCT01921218|OG000|Outcome|Belatacept Treatment Group|Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
11196417|NCT02164539|BG001|Baseline|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196418|NCT02164539|BG002|Baseline|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196419|NCT02164539|BG003|Baseline|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798301|NCT02955797|EG002|Reported Event|Group 3 (MenC-Primed): MenACYW Conjugate Vaccine|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10798302|NCT02955797|EG003|Reported Event|Group 4 (MenC-Primed): Nimenrix®|Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10798303|NCT02859415|BG000|Baseline|Phase I Dose Level 1 Mithramycin 60 mcg/kg|"Phase I Dose Level 1 Mithramycin 60 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.."
10798304|NCT02859415|BG001|Baseline|Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg|"Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses."
10798305|NCT02859415|BG002|Baseline|Total|Total of all reporting groups
10798306|NCT02859415|FG000|Participant Flow|Phase I Dose Level 1 Mithramycin 60 mcg/kg|"Phase I Dose Level 1 Mithramycin 60 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.."
10798307|NCT02859415|FG001|Participant Flow|Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg|"Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses."
10798308|NCT02859415|OG000|Outcome|All Participants|All participants in phase I dose level 1 and dose level -1.
10798309|NCT02859415|OG000|Outcome|Phase I Dose Level 1 Mithramycin 60 mcg/kg|"Phase I Dose Level 1 Mithramycin 60 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.."
10798310|NCT02859415|OG001|Outcome|Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg|"Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses."
10798311|NCT02859415|EG000|Reported Event|Phase I Dose Level 1 Mithramycin 60 mcg/kg|"Phase I Dose Level 1 Mithramycin 60 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.."
10798312|NCT02859415|EG001|Reported Event|Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg|"Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg~Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses."
10798313|NCT02842866|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
11384356|NCT01921218|OG001|Outcome|Control Group|Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
10798314|NCT02842866|BG001|Baseline|Group 2: Menomune® Vaccine|Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
10798315|NCT02842866|BG002|Baseline|Total|Total of all reporting groups
10798316|NCT02842866|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0.
10798317|NCT02842866|FG001|Participant Flow|Group 2: Menomune® Vaccine|Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0.
10798318|NCT02842866|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.
10798319|NCT02842866|OG001|Outcome|Group 2: Menomune® Vaccine|Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
10798320|NCT02842866|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.
10798321|NCT02842866|EG001|Reported Event|Group 2: Menomune® Vaccine|Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
10798322|NCT02842853|BG000|Baseline|MenACYW Conjugate Vaccine Lot 1|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
10798323|NCT02842853|BG001|Baseline|MenACYW Conjugate Vaccine Lot 2|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
11196420|NCT02164539|BG004|Baseline|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196421|NCT02164539|BG005|Baseline|FF/VI 100/25 µg|Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196422|NCT02164539|BG006|Baseline|Total|Total of all reporting groups
10798324|NCT02842853|BG002|Baseline|MenACYW Conjugate Vaccine Lot 3|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
10798325|NCT02842853|BG003|Baseline|Menactra®|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
10798326|NCT02842853|BG004|Baseline|Total|Total of all reporting groups
10798327|NCT02842853|FG000|Participant Flow|MenACYW Conjugate Vaccine Lot 1|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine from lot 1 on Day 0.
10798328|NCT02842853|FG001|Participant Flow|MenACYW Conjugate Vaccine Lot 2|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
10798329|NCT02842853|FG002|Participant Flow|MenACYW Conjugate Vaccine Lot 3|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
10798330|NCT02842853|FG003|Participant Flow|Menactra®|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
10798331|NCT02842853|OG000|Outcome|MenACYW Conjugate Vaccine Lot 1|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
10798332|NCT02842853|OG001|Outcome|MenACYW Conjugate Vaccine Lot 2|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
10798333|NCT02842853|OG002|Outcome|MenACYW Conjugate Vaccine Lot 3|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
11241291|NCT02486263|BG000|Baseline|Study|"Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions~Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)~Total fluid volume restriction (120-140 milliliters/kilogram/day)~Feeding duration over 30 minutes~Infant feeds with right side down~Infant is placed on back following feeds"
11241292|NCT02486263|BG001|Baseline|Conventional|Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
10798334|NCT02842853|OG000|Outcome|MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled)|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received single dose of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0.
10798335|NCT02842853|OG001|Outcome|Menactra®|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
10798336|NCT02842853|OG000|Outcome|MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled)|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received 0.5 mL of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0.
10798337|NCT02842853|EG000|Reported Event|MenACYW Conjugate Vaccine Lot 1|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
10798338|NCT02842853|EG001|Reported Event|MenACYW Conjugate Vaccine Lot 2|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
10798339|NCT02842853|EG002|Reported Event|MenACYW Conjugate Vaccine Lot 3|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
10798340|NCT02842853|EG003|Reported Event|Menactra|Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
10798341|NCT02752906|BG000|Baseline|MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
10798342|NCT02752906|BG001|Baseline|Menactra ®|Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
10798343|NCT02752906|BG002|Baseline|Total|Total of all reporting groups
10798344|NCT02752906|FG000|Participant Flow|MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine-primed adolescents (greater than or equal to [>=] 15 to less than [<] 18 years) or adults (>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
10798345|NCT02752906|FG001|Participant Flow|Menactra ®|Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ®) vaccine on Day 0.
10798346|NCT02752906|OG000|Outcome|MenACYW Conjugate Vaccine|Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
10798347|NCT02752906|OG001|Outcome|Menactra ®|Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
10798348|NCT02752906|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
10798349|NCT02752906|EG001|Reported Event|Group 2: Menactra ®|Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra vaccine on Day 0.
10798350|NCT02693691|BG000|Baseline|CardioMEMS HF System|"Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.~CardioMEMS HF System: Pulmonary Artery Pressure Monitoring"
10798351|NCT02693691|FG000|Participant Flow|CardioMEMS HF System|"Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.~CardioMEMS HF System: Pulmonary Artery Pressure Monitoring"
10798352|NCT02693691|OG000|Outcome|CardioMEMS HF System|"Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.~CardioMEMS HF System: Pulmonary Artery Pressure Monitoring"
10798353|NCT02693691|EG000|Reported Event|CardioMEMS HF System|"Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.~CardioMEMS HF System: Pulmonary Artery Pressure Monitoring"
10798354|NCT02540330|BG000|Baseline|Intramuscular Fulvestrant|"500mg fulvestrant administered intramuscularly~Fulvestrant"
10798355|NCT02540330|BG001|Baseline|Intraductal Fulvestrant|"up to 500mg fulvestrant administered intraductally~Fulvestrant"
10798356|NCT02540330|BG002|Baseline|Total|Total of all reporting groups
10798357|NCT02540330|FG000|Participant Flow|Intramuscular Fulvestrant|"500mg fulvestrant administered intramuscularly~Fulvestrant"
10798358|NCT02540330|FG001|Participant Flow|Intraductal Fulvestrant|"up to 500mg fulvestrant administered intraductally~Fulvestrant"
10798359|NCT02540330|OG000|Outcome|Intramuscular Route|500mg fulvestrant
11241293|NCT02486263|BG002|Baseline|Total|Total of all reporting groups
11241294|NCT02486263|FG000|Participant Flow|Study|"Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions~Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)~Total fluid volume restriction (120-140 milliliters/kilogram/day)~Feeding duration over 30 minutes~Infant feeds with right side down~Infant is placed on back following feeds"
10798360|NCT02540330|OG001|Outcome|Intraductal Route|up to 500mg fulvestrant
10798361|NCT02540330|EG000|Reported Event|Intramuscular Fulvestrant|"500mg fulvestrant administered intramuscularly~Fulvestrant"
10798362|NCT02540330|EG001|Reported Event|Intraductal Fulvestrant|"up to 500mg fulvestrant administered intraductally~Fulvestrant"
10798363|NCT02417701|BG000|Baseline|Treatment (Sapanisertib)|"Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sapanisertib: Given PO"
10798364|NCT02417701|FG000|Participant Flow|Treatment (Sapanisertib)|"Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sapanisertib: Given PO"
10798365|NCT02417701|OG000|Outcome|NFEL2 Squamous Cohort|Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10798366|NCT02417701|OG001|Outcome|KEAP1 Squamous Cohort|Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10798367|NCT02417701|OG002|Outcome|KRAS/NFE2L2 or KEAP1 NSCLC Cohort|Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10798368|NCT02417701|OG000|Outcome|Treatment (Sapanisertib)|"Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sapanisertib: Given PO"
10798369|NCT02417701|EG000|Reported Event|Treatment (Sapanisertib)|"Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Sapanisertib: Given PO"
10798370|NCT02388906|BG000|Baseline|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
10798371|NCT02388906|BG001|Baseline|Ipilimumab 10 mg/kg|Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
10798372|NCT02388906|BG002|Baseline|Total|Total of all reporting groups
10798373|NCT02388906|FG000|Participant Flow|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
10798374|NCT02388906|FG001|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
10798375|NCT02388906|OG000|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
10798376|NCT02388906|OG001|Outcome|Ipilimumab 10 mg/kg|Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
10798377|NCT02388906|EG000|Reported Event|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
10798378|NCT02388906|EG001|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
10798379|NCT02384993|BG000|Baseline|Usual Physical Activity|"Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging. These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program."
10803420|NCT04551677|FG000|Participant Flow|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months|Participants aged 6 to less than (<) 36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.
10803421|NCT04551677|FG001|Participant Flow|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years|Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
11384357|NCT01921218|EG000|Reported Event|Belatacept Treatment Group|Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
10798380|NCT02384993|BG001|Baseline|Enhanced Physical Activity|Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
10798381|NCT02384993|BG002|Baseline|Total|Total of all reporting groups
10798382|NCT02384993|FG000|Participant Flow|Usual Physical Activity|"Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging. These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program."
10798383|NCT02384993|FG001|Participant Flow|Enhanced Physical Activity|Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
10798384|NCT02384993|OG000|Outcome|Enhanced Physical Activity|Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
10798385|NCT02384993|OG000|Outcome|Usual Physical Activity|"Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging. These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program."
10798386|NCT02384993|OG001|Outcome|Enhanced Physical Activity|Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
10798387|NCT02384993|EG000|Reported Event|Enhanced Physical Activity|Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
10798388|NCT02384993|EG001|Reported Event|Usual Physical Activity|"Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging. These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program."
10803422|NCT04551677|FG002|Participant Flow|Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years|Participants aged greater than or equal to (>=) 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
11384358|NCT01921218|EG001|Reported Event|Control Group|Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
10798389|NCT02304302|BG000|Baseline|Placebo|"Identically looking placebo capsules to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)"
10798390|NCT02304302|BG001|Baseline|Memantine|"Memantine capsules were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798391|NCT02304302|BG002|Baseline|Total|Total of all reporting groups
10798392|NCT02304302|FG000|Participant Flow|Placebo|"Identically-looking placebo capsules to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)"
10798393|NCT02304302|FG001|Participant Flow|Memantine|"Memantine capsules were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798394|NCT02304302|OG000|Outcome|Placebo|"Identically looking placebo pills to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)"
10798395|NCT02304302|OG001|Outcome|Memantine|"Memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798396|NCT02304302|OG000|Outcome|Placebo|"Identically looking placebo capsules to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)"
10798397|NCT02304302|OG001|Outcome|Memantine|"Memantine capsules were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798398|NCT02304302|OG000|Outcome|Placebo|"Identically-looking placebo pills to memantine will be dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen after a four-week regimen designed to mimic standard dose titration protocol)"
10798399|NCT02304302|OG001|Outcome|Memantine|"Memantine will be dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798400|NCT02304302|EG000|Reported Event|Placebo|"Identically looking placebo capsules to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)"
10798401|NCT02304302|EG001|Reported Event|Memantine|"Memantine capsules were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3.~Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol)"
10798402|NCT02269670|BG000|Baseline|Treatment (Everolimus, Hormone Therapy)|"Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO~anastrozole: Given PO~letrozole: Given PO~tamoxifen citrate: Given PO~fulvestrant: Given IM or PO~megestrol acetate: Given PO"
10798403|NCT02269670|FG000|Participant Flow|Treatment (Everolimus, Hormone Therapy)|"Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO~anastrozole: Given PO~letrozole: Given PO~tamoxifen citrate: Given PO~fulvestrant: Given IM or PO~megestrol acetate: Given PO"
10798404|NCT02269670|OG000|Outcome|Treatment (Everolimus, Hormone Therapy)|"Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO~anastrozole: Given PO~letrozole: Given PO~tamoxifen citrate: Given PO~fulvestrant: Given IM or PO~megestrol acetate: Given PO"
10798405|NCT02269670|EG000|Reported Event|Treatment (Everolimus, Hormone Therapy)|"Patients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.~everolimus: Given PO~anastrozole: Given PO~letrozole: Given PO~tamoxifen citrate: Given PO~fulvestrant: Given IM or PO~megestrol acetate: Given PO"
10798406|NCT02086175|BG000|Baseline|Imprime PGG and Rituximab|"The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment~Imprime PGG~Rituximab"
11384359|NCT01923168|BG000|Baseline|Alpelisib + Letrozole|Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
10798407|NCT02086175|FG000|Participant Flow|Imprime PGG and Rituximab|"The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment~Imprime PGG~Rituximab"
10798408|NCT02086175|OG000|Outcome|Imprime PGG and Rituximab|"The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment~Imprime PGG~Rituximab"
10798409|NCT02086175|EG000|Reported Event|Imprime PGG and Rituximab|"The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment~Imprime PGG~Rituximab"
10798410|NCT01860976|BG000|Baseline|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
10798411|NCT01860976|BG001|Baseline|Placebo|Placebo, self-administered subcutaneously, once weekly.
10798412|NCT01860976|BG002|Baseline|Total|Total of all reporting groups
10798413|NCT01860976|FG000|Participant Flow|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
10798414|NCT01860976|FG001|Participant Flow|Placebo|Placebo, self-administered subcutaneously, once weekly.
10798415|NCT01860976|OG000|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
10798416|NCT01860976|OG001|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
10798417|NCT01860976|EG000|Reported Event|ABATACEPT DURING DOUBLE-BLIND PERIOD|
10798418|NCT01860976|EG001|Reported Event|PLACEBO DURING DOUBLE-BLIND PERIOD|
10798419|NCT01860976|EG002|Reported Event|ABATACEPT DURING OPEN-LABEL PERIOD|
10798420|NCT01860976|EG003|Reported Event|ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD|
10798421|NCT01860976|EG004|Reported Event|ABATACEPT DURING LONG-TERM EXTENSION PERIOD|
10798422|NCT01761266|BG000|Baseline|Lenvatinib|Participants received lenvatinib capsules 12 mg based on the participant's body weight >=60 kg or 8 mg based on the participant's body weight <60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798423|NCT01761266|BG001|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798424|NCT01761266|BG002|Baseline|Total|Total of all reporting groups
10798425|NCT01761266|FG000|Participant Flow|Lenvatinib|Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798426|NCT01761266|FG001|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798427|NCT01761266|OG000|Outcome|Lenvatinib|Participants received lenvatinib capsules 12 mg based on the participant's body weight >=60 kg or 8 mg based on the participant's body weight <60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798428|NCT01761266|OG001|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798429|NCT01761266|OG000|Outcome|Lenvatinib|Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798430|NCT01761266|OG000|Outcome|Lenvatinib 8 mg|Participants received lenvatinib capsules 12 mg based on the participant's body weight >=60 kg or 8 mg based on the participant's body weight <60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798431|NCT01761266|OG001|Outcome|Lenvatinib 12 mg|Participants received lenvatinib 12 mg capsules based on the participant's body weight (>=60 kg) at Baseline, orally, once daily in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798432|NCT01761266|EG000|Reported Event|Lenvatinib|Participants received lenvatinib capsules 12 mg based on the participant's body weight >=60 kg or 8 mg based on the participant's body weight <60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798433|NCT01761266|EG001|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
10798434|NCT01550289|BG000|Baseline|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
10798435|NCT01550289|BG001|Baseline|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
10798436|NCT01550289|BG002|Baseline|Total|Total of all reporting groups
10798437|NCT01550289|FG000|Participant Flow|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
10798438|NCT01550289|FG001|Participant Flow|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
10798439|NCT01550289|OG000|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
10798440|NCT01550289|OG001|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
10798441|NCT01550289|OG000|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
10798442|NCT01550289|OG001|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
10798443|NCT01550289|EG000|Reported Event|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
10798444|NCT01550289|EG001|Reported Event|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
10798445|NCT01346709|BG000|Baseline|In-patient Adult Non-obstetricSurgical|"Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).~All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible."
10798446|NCT01346709|FG000|Participant Flow|In-patient Adult Non-obstetricSurgical|"Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).~All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible."
11196423|NCT02164539|FG000|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
11196424|NCT02164539|FG001|Participant Flow|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196425|NCT02164539|FG002|Participant Flow|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196426|NCT02164539|FG003|Participant Flow|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196427|NCT02164539|FG004|Participant Flow|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798447|NCT01346709|OG000|Outcome|In-patient Adult Non-obstetricSurgical|"Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).~All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible."
10798448|NCT01346709|EG000|Reported Event|Observational Study Section Not Applicable|observational study section not applicable
10798449|NCT01081951|BG000|Baseline|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
10798450|NCT01081951|BG001|Baseline|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
10798451|NCT01081951|BG002|Baseline|Total|Total of all reporting groups
10798452|NCT01081951|FG000|Participant Flow|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
10798453|NCT01081951|FG001|Participant Flow|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
10798454|NCT01081951|OG000|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
11196428|NCT02164539|FG005|Participant Flow|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196429|NCT02164539|FG006|Participant Flow|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196430|NCT02164539|OG000|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
11384360|NCT01923168|BG001|Baseline|Buparlisib + Letrozole|Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
10798455|NCT01081951|OG001|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
10798456|NCT01081951|EG000|Reported Event|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
10798457|NCT01081951|EG001|Reported Event|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
10798458|NCT01074190|BG000|Baseline|Group 1|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL~Group 1: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798459|NCT01074190|BG001|Baseline|Group 2|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL~Group 2: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798460|NCT01074190|BG002|Baseline|Group 3|"spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL~Group 3: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798461|NCT01074190|BG003|Baseline|Total|Total of all reporting groups
10798462|NCT01074190|FG000|Participant Flow|Group 1|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL~Group 1: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798463|NCT01074190|FG001|Participant Flow|Group 2|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL~Group 2: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798464|NCT01074190|FG002|Participant Flow|Group 3|"spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL~Group 3: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798465|NCT01074190|OG000|Outcome|Group 1|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL~Group 1: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798466|NCT01074190|OG001|Outcome|Group 2|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL~Group 2: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798467|NCT01074190|OG002|Outcome|Group 3|"spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL~Group 3: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798468|NCT01074190|OG003|Outcome|Total|Cumulative Fentanyl Group 1-3
10798469|NCT01074190|OG003|Outcome|Total|Plasma fentanyl concentrations (ng/mL) Group 1-3
10798470|NCT01074190|OG003|Outcome|Total|Umbilical vein plasma fentanyl concentrations (ng/mL) Group 1-3
10798471|NCT01074190|EG000|Reported Event|Group 1|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL~Group 1: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798472|NCT01074190|EG001|Reported Event|Group 2|"spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL~Group 2: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798473|NCT01074190|EG002|Reported Event|Group 3|"spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL~Group 3: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl."
10798474|NCT00875524|BG000|Baseline|CYD Dengue Vaccine Group|Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
10798475|NCT00875524|BG001|Baseline|Control Group|Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
10798476|NCT00875524|BG002|Baseline|Total|Total of all reporting groups
10798477|NCT00875524|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injection. Participants were followed for 4 years after the third injection.
10798478|NCT00875524|FG001|Participant Flow|Control Vaccine Group|Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
10798479|NCT00875524|OG000|Outcome|CYD Dengue Vaccine Group|Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
10798480|NCT00875524|OG001|Outcome|Control Vaccine Group|Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
10798481|NCT00875524|EG000|Reported Event|CYD Dengue Vaccine Group|Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
10798482|NCT00875524|EG001|Reported Event|Control Vaccine Group|Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
10798483|NCT00842530|BG000|Baseline|CYD Dengue Vaccine Group|Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6 months, and 12 months.
10798484|NCT00842530|BG001|Baseline|Control Group|Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (Cohort 2) received placebo at 0, 6, and 12 months.
10798485|NCT00842530|BG002|Baseline|Total|Total of all reporting groups
10798486|NCT00842530|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6 months, and 12 months.
10798487|NCT00842530|FG001|Participant Flow|Control Group|Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (Cohort 2) received placebo at 0, 6, and 12 months.
10798488|NCT00842530|OG000|Outcome|CYD Dengue Vaccine Group|Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6, and 12 months.
11196431|NCT02164539|OG001|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798489|NCT00842530|OG001|Outcome|Control Group|Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (Cohort 2) received placebo at 0, 6, and 12 months.
11196432|NCT02164539|OG002|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798490|NCT00842530|OG000|Outcome|CYD Dengue Vaccine Group|Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6 months, and 12 months.
10798491|NCT00842530|EG000|Reported Event|CYD Dengue Vaccine Group|Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6, and 12 months.
10798492|NCT00842530|EG001|Reported Event|Control Group|Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (Cohort 2) received placebo at 0, 6, and 12 months.
10798493|NCT00788151|BG000|Baseline|CYD Dengue Vaccine Group|Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798494|NCT00788151|BG001|Baseline|Control Group|Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798495|NCT00788151|BG002|Baseline|Total|Total of all reporting groups
10798496|NCT00788151|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798497|NCT00788151|FG001|Participant Flow|Control Group|Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798498|NCT00788151|OG000|Outcome|CYD Dengue Vaccine Group|Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798499|NCT00788151|OG001|Outcome|Control Group|Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798500|NCT00788151|EG000|Reported Event|CYD Dengue Vaccine Group|Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
10798501|NCT00788151|EG001|Reported Event|Control Group|Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
11196433|NCT02164539|OG003|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196434|NCT02164539|OG004|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196435|NCT02164539|OG005|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196436|NCT02164539|EG000|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
11196437|NCT02164539|EG001|Reported Event|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196438|NCT02164539|EG002|Reported Event|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798502|NCT00539591|BG000|Baseline|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
10798503|NCT00539591|BG001|Baseline|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
10798504|NCT00539591|BG002|Baseline|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
10798505|NCT00539591|BG003|Baseline|Total|Total of all reporting groups
10798506|NCT00539591|FG000|Participant Flow|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
11196439|NCT02164539|EG003|Reported Event|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196440|NCT02164539|EG004|Reported Event|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
10798507|NCT00539591|FG001|Participant Flow|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
11196441|NCT02164539|EG005|Reported Event|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196442|NCT02164539|EG006|Reported Event|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
11196443|NCT02164721|BG000|Baseline|CRT-D (Defibrillator)|"Implantation of a three-lead CRT-D (Defibrillator) in all registered patients~Three-lead CRT-D (Defibrillator): The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead."
11196444|NCT02164721|FG000|Participant Flow|CRT-D (Defibrillator)|"Implantation of a three-lead Cardiac Resynchronization Therapy -Defibrillator (CRT-D) in all registered patients~Three-lead CRT-D (Defibrillator): The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead."
11196445|NCT02164721|OG000|Outcome|CRT-D (Defibrillator)|Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
11384361|NCT01923168|BG002|Baseline|Placebo + Letrozole|Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
11196446|NCT02164721|OG000|Outcome|CRT-D (Defibrillator)|"Implantation of a three-lead CRT-D (Defibrillator) in all registered patients~Three-lead CRT-D (Defibrillator): The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead."
11196447|NCT02164721|EG000|Reported Event|CRT-D (Defibrillator)|Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
11196448|NCT02164864|BG000|Baseline|Dabigatran Etexilate 110mg|Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
11196449|NCT02164864|BG001|Baseline|Dabigatran Etexilate 150mg|Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
11196450|NCT02164864|BG002|Baseline|Warfarin|Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
10798508|NCT00539591|FG002|Participant Flow|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
10798509|NCT00539591|OG000|Outcome|Stratum B1|"Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease~Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.~Interventions: Temozolomide, peginterferon ɑ-2b"
10798510|NCT00539591|OG000|Outcome|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
10798511|NCT00539591|OG001|Outcome|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
10798512|NCT00539591|OG000|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
10798513|NCT00539591|OG000|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
11196451|NCT02164864|BG003|Baseline|Total|Total of all reporting groups
11196452|NCT02164864|FG000|Participant Flow|Dabigatran Etexilate 110mg|Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
11196453|NCT02164864|FG001|Participant Flow|Dabigatran Etexilate 150mg|Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
11196454|NCT02164864|FG002|Participant Flow|Warfarin|Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
11196455|NCT02164864|OG000|Outcome|Dabigatran Etexilate 110mg|Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
11196456|NCT02164864|OG001|Outcome|Dabigatran Etexilate 150mg|Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
11196457|NCT02164864|OG002|Outcome|Warfarin|Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
11196458|NCT02164864|OG003|Outcome|Warfarin (Excluding Elder Patients Outside USA)|Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
11196459|NCT02164864|OG003|Outcome|Warfarin (Excluding Elder Patients Outside USA|Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
11196460|NCT02164864|OG004|Outcome|All Dabigatran Etexilate|Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
11196461|NCT02164864|EG000|Reported Event|Dabigatran Etexilate 110mg|Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
11196462|NCT02164864|EG001|Reported Event|Dabigatran Etexilate 150mg|Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
11196463|NCT02164864|EG002|Reported Event|Warfarin|Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
11196464|NCT02164916|BG000|Baseline|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
10798514|NCT00539591|OG000|Outcome|Week 5 - First Dose|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
10798515|NCT00539591|OG001|Outcome|Week 28 - Steady State|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
10798516|NCT00539591|OG000|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
10798517|NCT00539591|OG000|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
10798518|NCT00539591|OG000|Outcome|Pretherapy|QoL assessment completed before start of therapy.
10798519|NCT00539591|OG001|Outcome|Week 2|QoL assessment completed at Week 2.
10798520|NCT00539591|OG002|Outcome|Week 4|QoL assessment completed at Week 4.
10798521|NCT00539591|OG003|Outcome|Week 8|QoL assessment completed at Week 8.
10798522|NCT00539591|OG004|Outcome|Week 12|QoL assessment completed at Week 12.
10798523|NCT00539591|OG005|Outcome|Week 24|QoL assessment completed at Week 24.
10798524|NCT00539591|OG006|Outcome|End of Therapy|QoL assessment completed at end of therapy.
10798525|NCT00539591|OG007|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
10798526|NCT00539591|OG008|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
10798527|NCT00539591|OG000|Outcome|Week 2|QoL assessment completed at Week 2.
10798528|NCT00539591|OG001|Outcome|Week 4|QoL assessment completed at Week 4.
10798529|NCT00539591|OG002|Outcome|Week 8|QoL assessment completed at Week 8.
10798530|NCT00539591|OG003|Outcome|Week 12|QoL assessment completed at Week 12.
10798531|NCT00539591|OG004|Outcome|Week 24|QoL assessment completed at Week 24.
10798532|NCT00539591|OG005|Outcome|End of Therapy|QoL assessment completed at end of therapy.
10798533|NCT00539591|OG006|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
10798534|NCT00539591|OG007|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
10798535|NCT00539591|OG000|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
10798536|NCT00539591|OG001|Outcome|Week 4|Psychological assessment completed at Week 4
10798537|NCT00539591|OG002|Outcome|Week 24|Psychological assessment completed at Week 24
10798538|NCT00539591|OG003|Outcome|End of Therapy|QoL assessment completed at end of therapy.
10798539|NCT00539591|OG004|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
10798540|NCT00539591|EG000|Reported Event|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
10798541|NCT00539591|EG001|Reported Event|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
10798542|NCT00539591|EG002|Reported Event|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
11202322|NCT02207231|OG001|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
10803423|NCT04551677|OG000|Outcome|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803424|NCT04551677|OG001|Outcome|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years|Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803425|NCT04551677|OG000|Outcome|Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years|Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
10803426|NCT04551677|EG000|Reported Event|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803427|NCT04551677|EG001|Reported Event|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years|Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803428|NCT04551677|EG002|Reported Event|Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years|Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
10803429|NCT04498832|BG000|Baseline|QIV-HD|Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
10803430|NCT04498832|BG001|Baseline|QIV-SD|Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
10803431|NCT04498832|BG002|Baseline|Total Title|
10803432|NCT04498832|FG000|Participant Flow|QIV-HD|Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
11196465|NCT02164916|BG001|Baseline|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
11196466|NCT02164916|BG002|Baseline|Total|Total of all reporting groups
11196467|NCT02164916|FG000|Participant Flow|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
11196468|NCT02164916|FG001|Participant Flow|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
11196469|NCT02164916|OG000|Outcome|Arm I (Cetuximab, Irinotecan Hydrochloride)|"Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.~cetuximab: Given IV~irinotecan hydrochloride: Given IV"
11196470|NCT02164916|OG001|Outcome|Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)|"Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~irinotecan hydrochloride: Given IV~vemurafenib: Given PO"
11196471|NCT02164916|OG000|Outcome|Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196472|NCT02164916|OG001|Outcome|Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196473|NCT02164916|OG002|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196474|NCT02164916|OG000|Outcome|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196475|NCT02164916|EG000|Reported Event|Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196476|NCT02164916|EG001|Reported Event|Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196477|NCT02164916|EG002|Reported Event|Crossover: Vemurafenib + Cetuximab + Irinotecan|Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11196478|NCT02164929|BG000|Baseline|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196479|NCT02164929|BG001|Baseline|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196480|NCT02164929|BG002|Baseline|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
11202323|NCT02207231|OG000|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
11384362|NCT01923168|BG003|Baseline|Total|Total of all reporting groups
11384363|NCT01923168|FG000|Participant Flow|Alpelisib + Letrozole|Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
11196481|NCT02164929|BG003|Baseline|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196482|NCT02164929|BG004|Baseline|Total|Total of all reporting groups
10798543|NCT04794751|BG000|Baseline|Dispensed Subjects|All subjects dispensed a study lens.
10798544|NCT04794751|FG000|Participant Flow|Delefilcon A/Senofilcon A C3/Senofilcon A C3|Subjects randomized to this sequence received the delefilcon A lens during the first period and then received the senofilcon A C3 lenses during the second and third periods.
10798545|NCT04794751|FG001|Participant Flow|Senofilcon A C3/Delefilcon A/Delefilcon A|Subjects randomized to this sequence received the senofilcon A C3 lens during the first period and then received the delefilcon A lenses during the second and third periods.
10798546|NCT04794751|OG000|Outcome|Senofilcon A C3|Subjects that wore the Test lens in either of the three study periods.
10798547|NCT04794751|OG001|Outcome|Delefilcon A|Subjects that wore the Control lens in either of the three study periods.
10798548|NCT04794751|EG000|Reported Event|Senofilcon A C3|Subjects that wore the Test lens in either of the three study periods.
10798549|NCT04794751|EG001|Reported Event|Delefilcon A|Subjects that wore the Control lens in either of the three study periods.
10798550|NCT04584645|BG000|Baseline|Cardiovascular Disorders Digital Intervention Arm (CVD-I)|"Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination~Targeted digital intervention: Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors."
10798551|NCT04584645|BG001|Baseline|Cardiovascular Disorders Without Digital Intervention Arm|Individuals with cardiovascular disease who receive no intervention
10798552|NCT04584645|BG002|Baseline|Total|Total of all reporting groups
11196483|NCT02164929|FG000|Participant Flow|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11202324|NCT02207231|OG001|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
11202325|NCT02207231|OG000|Outcome|Guselkumab|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
10798553|NCT04584645|FG000|Participant Flow|Cardiovascular Disorders Digital Intervention Arm (CVD-I)|"Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination~Targeted digital intervention: Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors."
10798554|NCT04584645|FG001|Participant Flow|Cardiovascular Disorders Without Digital Intervention Arm|Individuals with cardiovascular disease who receive no intervention
10798555|NCT04584645|OG000|Outcome|Cardiovascular Disorders Digital Intervention Arm (CVD-I)|"Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination~Targeted digital intervention: Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors."
10798556|NCT04584645|OG001|Outcome|Cardiovascular Disorders Without Digital Intervention Arm|Individuals with cardiovascular disease who receive no intervention
10798557|NCT04584645|OG000|Outcome|Participants Who Reported Influenza Vaccine After Completing 0 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 0 Intervention Messages Through Study Close
10798558|NCT04584645|OG001|Outcome|Participants Who Reported Influenza Vaccine After Completing 1 Intervention|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 1 Intervention Message Through Study Close
10798559|NCT04584645|OG002|Outcome|Participants Who Reported Influenza Vaccine After Completing 2 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close
10798560|NCT04584645|OG003|Outcome|Participants Who Reported Influenza Vaccine After Completing 3 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close
10798561|NCT04584645|OG004|Outcome|Participants Who Reported Influenza Vaccine After Completing 4 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close
10798562|NCT04584645|OG005|Outcome|Participants Who Reported Influenza Vaccine After Completing 5 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close
10798563|NCT04584645|OG006|Outcome|Participants Who Reported Influenza Vaccine After Completing 6 Interventions|Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
10798564|NCT04584645|OG000|Outcome|Completion Rate of Educational Videos|"Percentage of Participants that Completed the Intervention Educational Videos"
10798565|NCT04584645|OG001|Outcome|Completion Rate of Knowledge Quiz|"Percentage of Participants that Completed the Intervention Knowledge Quiz"
10798566|NCT04584645|OG002|Outcome|Completion Rate of Cost Article|"Percentage of Participants that Completed the Intervention Cost Article"
10798567|NCT04584645|OG003|Outcome|Completion Rate of CDC Heart-Focused Article|"Percentage of Participants that Completed the Intervention CDC Heart-Focused Article"
10798568|NCT04584645|OG004|Outcome|Completion Rate of Location Finder|"Percentage of Participants that Completed the Intervention Location Finder"
10798569|NCT04584645|OG005|Outcome|Completion Rate of Date Setter|"Percentage of Participants that Completed the Intervention Date Setter"
10798570|NCT04584645|OG000|Outcome|Influenza Vaccine Offered|"The health behavior Influenza Vaccine Offered as a predictor of influenza vaccination"
10798571|NCT04584645|OG001|Outcome|High Risk Group Informed|"The health behavior High Risk Group Informed as a predictor of influenza vaccination"
10798572|NCT04584645|OG002|Outcome|Sees Primary Care Physician|"The health behavior Sees Primary Care Physician as a predictor of influenza vaccination"
10798573|NCT04584645|OG003|Outcome|Hospitalized|"The health behavior Hospitalized as a predictor of influenza vaccination"
10798574|NCT04584645|OG004|Outcome|Sees Cardiologist|"The health behavior Sees Cardiologist as a predictor of influenza vaccination"
11202326|NCT02207231|OG001|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
11202327|NCT02207231|OG000|Outcome|Guselkumab Combined|All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
10798575|NCT04584645|EG000|Reported Event|Cardiovascular Disorders Digital Intervention Arm (CVD-I)|"Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination~Targeted digital intervention: Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors."
10798576|NCT04584645|EG001|Reported Event|Cardiovascular Disorders Without Digital Intervention Arm|Individuals with cardiovascular disease who receive no intervention
10798577|NCT04538170|BG000|Baseline|ORC Group Orchidectomy Following Cancer|"Group orchidectomy following cancer~pain after surgery"
10798578|NCT04538170|BG001|Baseline|GAC Group Sex Reassignment Surgery|"Group sex reassignment surgery~pain after surgery"
10798579|NCT04538170|BG002|Baseline|Total|Total of all reporting groups
10798580|NCT04538170|FG000|Participant Flow|(ORC) Orchiectomy Following Cancer|158 men who had undergone tumor orchidectomy between 2010 and 2014
10798581|NCT04538170|FG001|Participant Flow|(GAC) Group Sex Reassignment Surgery|265 transsexual women who had undergone surgery between 2002 and 2014
10798582|NCT04538170|OG000|Outcome|ORC Group Orchidectomy Following Cancer|phantom pain of testis after surgically removal
10798583|NCT04538170|OG001|Outcome|GAC Group Sex Reassignment Surgery|pantom pain of testes after surgically removal
10798584|NCT04538170|OG000|Outcome|ORC Group Orchidectomy Following Cancer|patients should give information about any type of incontinence
10798585|NCT04538170|OG001|Outcome|GAC Group Sex Reassignment Surgery|patients should give information about any type of incontinence
10798586|NCT04538170|OG000|Outcome|ORC Group Orchidectomy Following Cancer|chronic pain in the region of surgery but not phantom pain
10798587|NCT04538170|OG001|Outcome|GAC Group Sex Reassignment Surgery|chronic pain in the region of surgery but not phantom pain
10798588|NCT04538170|EG000|Reported Event|GAC Gender Reassignment Surgery|55 transsexual women who had undergone gender reassignment surgery answer a questionnaire
10798589|NCT04538170|EG001|Reported Event|ORC Patients After Inguinal Orchidectomy for Testicular Tumor|54 patients after inguinal orchidectomy for testicular tumor, answer a questionnaire
10798590|NCT04461015|BG000|Baseline|0.4 Then 0.8|"Subjects will undergo the 0.4 clamp first during which insulin is infused at 0.4mU/Kg/Min~following a suitable washout period,~Subjects will undergo the 0.8 clamp second during which insulin is infused at 0.8mU/Kg/Min"
10798591|NCT04461015|BG001|Baseline|0.8 Then 0.4|"Subjects will undergo the 0.8 clamp first during which insulin is infused at 0.8mU/Kg/Min~following a suitable washout period,~Subjects will undergo the 0.4 clamp second during which insulin is infused at 0.4mU/Kg/Min"
10798592|NCT04461015|BG002|Baseline|Total|Total of all reporting groups
10798593|NCT04461015|FG000|Participant Flow|0.4 Then 0.8|"During the first euglycemic clamp insulin will be infused at 0.4mU/Kg/Min~Subjects will undergo a 15 day 'withdrawal period'~During the second euglycemic clamp insulin will be infused at 0.8mU/Kg/Min"
10798594|NCT04461015|FG001|Participant Flow|0.8 Then 0.4|"During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min~Subjects will undergo a 15 day 'withdrawal period'~During the second euglycemic clamp insulin will be infused at 0.4mU/Kg/Min"
10798595|NCT04461015|OG000|Outcome|0.4mU Insulin|"During the euglycemic clamp insulin will be infused at 0.4mU/Kg/Min~0.4mU Insulin: Insulin infused at 0.4 mU/Kg/min"
10798596|NCT04461015|OG001|Outcome|0.8mU Insulin|"During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min~0.8mU Insulin: Insulin infused at 0.8 mU/Kg/min"
10798597|NCT04461015|EG000|Reported Event|0.4 Events|Events occurring during the 0.4 euglycemic clamp when insulin was infused at 0.4mU/Kg/Min
10798598|NCT04461015|EG001|Reported Event|0.8 Events|Events occurring during the 0.8 euglycemic clamp when insulin was infused at 0.8mU/Kg/Min
11196484|NCT02164929|FG001|Participant Flow|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196485|NCT02164929|FG002|Participant Flow|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
11196486|NCT02164929|FG003|Participant Flow|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196487|NCT02164929|OG000|Outcome|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196488|NCT02164929|OG001|Outcome|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11384364|NCT01923168|FG001|Participant Flow|Buparlisib + Letrozole|Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
10798599|NCT04380961|BG000|Baseline|Sirukumab + SOC|Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
10798600|NCT04380961|BG001|Baseline|Placebo + SOC|Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
10798601|NCT04380961|BG002|Baseline|Total|Total of all reporting groups
10798602|NCT04380961|FG000|Participant Flow|Sirukumab + SOC|Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
10798603|NCT04380961|FG001|Participant Flow|Placebo + SOC|Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
10798604|NCT04380961|OG000|Outcome|Sirukumab + SOC|Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
10798605|NCT04380961|OG001|Outcome|Placebo + SOC|Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
10798606|NCT04380961|EG000|Reported Event|Sirukumab + Standard of Care (SOC): Treatment Phase|Hospitalized participants with confirmed coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with SOC treatment per the discretion of the Investigator.
10798607|NCT04380961|EG001|Reported Event|Sirukumab + SOC: Follow-up Phase|Hospitalized participants with confirmed COVID-19 received IV single dose infusion of sirukumab 5 mg/kg on Day 1 along with SOC treatment per the discretion of the Investigator.
10798608|NCT04380961|EG002|Reported Event|Placebo + SOC: Treatment Phase|Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
10798609|NCT04380961|EG003|Reported Event|Placebo + SOC: Follow-up Phase|Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
10798626|NCT04341441|BG000|Baseline|Study Drug - Daily Dose|"200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798627|NCT04341441|BG001|Baseline|Study Drug - Weekly Dose|"6.5 mg/kg per dose (maximum of 400mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798628|NCT04341441|BG002|Baseline|Placebo|"Placebo oral tablet: Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day.~All treatment groups will receive placebo pills to have the patients take 2 pills a day. The randomized placebo arm will receive placebo pills made to resemble the daily dosing of HCQ. Similarly, the once a week treatment arm will receive placebo pills for the days not on HCQ medication."
10798629|NCT04341441|BG003|Baseline|Non-Randomized Active Comparator|"This will be an open enrollment group and will provide information of chronic weight-based daily therapy of HCQ effectiveness as a prophylactic/preventive strategy.~This non-randomized comparator group will be enrolled in the study comprising of healthcare workers and first responders who are chronically on oral hydroxychloroquine as part of their standard of care for their autoimmune disease(s)."
10798630|NCT04341441|BG004|Baseline|Total|Total of all reporting groups
10798631|NCT04341441|FG000|Participant Flow|Study Drug - Daily Dose|"200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798632|NCT04341441|FG001|Participant Flow|Study Drug - Weekly Dose|"6.5 mg/kg per dose (maximum of 400mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798633|NCT04341441|FG002|Participant Flow|Placebo|"Placebo oral tablet: Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day.~All treatment groups will receive placebo pills to have the patients take 2 pills a day. The randomized placebo arm will receive placebo pills made to resemble the daily dosing of HCQ. Similarly, the once a week treatment arm will receive placebo pills for the days not on HCQ medication."
10798634|NCT04341441|FG003|Participant Flow|Non-Randomized Active Comparator (HCQ Cohort)|This non-randomized comparator group is comprised of healthcare workers and first responders who are chronically on oral hydroxychloroquine as part of standard of care for autoimmune disease(s).
10798635|NCT04341441|OG000|Outcome|Study Drug - Daily Dose|"200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798636|NCT04341441|OG001|Outcome|Study Drug - Weekly Dose|"6.5 mg/kg per dose (maximum of 400mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798637|NCT04341441|OG002|Outcome|Placebo|"Placebo oral tablet: Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day.~All treatment groups will receive placebo pills to have the patients take 2 pills a day. The randomized placebo arm will receive placebo pills made to resemble the daily dosing of HCQ. Similarly, the once a week treatment arm will receive placebo pills for the days not on HCQ medication."
10798638|NCT04341441|OG003|Outcome|Non-Randomized Active Comparator|"This will be an open enrollment group and will provide information of chronic weight-based daily therapy of HCQ effectiveness as a prophylactic/preventive strategy.~This non-randomized comparator group will be enrolled in the study comprising of healthcare workers and first responders who are chronically on oral hydroxychloroquine as part of their standard of care for their autoimmune disease(s)."
10798639|NCT04341441|EG000|Reported Event|Study Drug - Daily Dose|"200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798640|NCT04341441|EG001|Reported Event|Study Drug - Weekly Dose|"6.5 mg/kg per dose (maximum of 400mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria.~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
10798641|NCT04341441|EG002|Reported Event|Placebo|"Placebo oral tablet: Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day.~All treatment groups will receive placebo pills to have the patients take 2 pills a day. The randomized placebo arm will receive placebo pills made to resemble the daily dosing of HCQ. Similarly, the once a week treatment arm will receive placebo pills for the days not on HCQ medication."
10798642|NCT04341441|EG003|Reported Event|Non-Randomized Active Comparator (HCQ Cohort)|This non-randomized comparator group is comprised of healthcare workers and first responders who are chronically on oral hydroxychloroquine as part of their standard of care for autoimmune disease(s).
10798643|NCT04332419|BG000|Baseline|PET/CT & PET/MR|"One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.~PET/CT: Standard Imaging~PET/MR: Additional Imaging~SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy."
11196489|NCT02164929|OG002|Outcome|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
11196490|NCT02164929|OG003|Outcome|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11202328|NCT02207231|OG001|Outcome|Adalimumab Then Guselkumab 100 mg|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
11202329|NCT02207231|EG000|Reported Event|Placebo (PCP)|Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
10798644|NCT04332419|FG000|Participant Flow|PET/CT & PET/MR|"One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.~PET/CT: Standard Imaging~PET/MR: Additional Imaging~SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy."
10798645|NCT04332419|OG000|Outcome|PET/CT & PET/MR|"One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.~PET/CT: Standard Imaging~PET/MR: Additional Imaging~SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy."
10798646|NCT04332419|EG000|Reported Event|PET/CT & PET/MR|"One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.~PET/CT: Standard Imaging~PET/MR: Additional Imaging~SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy."
10803433|NCT04498832|FG001|Participant Flow|QIV-SD|Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
10798647|NCT04239872|BG000|Baseline|Participants With Normal Salivary Flow to Dry Mouth|"Participants were randomly assigned to two arms, with varying sequence of treatment used, under a crossover design: Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash; OR Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone~Fluoride mouthwash consisted of Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), used to rinse the mouth for 1 minute and expectorated.~Calcium and fluoride mouthwash: Calcium lactate, at a concentration of 150 millimoles per liter, used to rinse the mouth for 1 minute and expectorated; immediately after, a sodium fluoride rinse, at a concentration of 0.05% (226 ppm of fluoride), used to rinse the mouth for 1 minute, and expectorated."
10798648|NCT04239872|FG000|Participant Flow|Fluoride Mouthwash Alone, Then Calcium Mouthwash Before a Fluoride Mouthwash|Participants with normal to dry mouth first tested a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. After a washout period of at least 3 days, they then tested a Calcium mouthwash (150 millimoles per liter of calcium) immediately before the Fluoride mouthwash, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours.
10798649|NCT04239872|FG001|Participant Flow|Calcium Mouthwash Before a Fluoride Mouthwash, Then Fluoride Mouthwash Alone|Participants with normal to dry mouth first tested a Calcium mouthwash (150 millimoles per liter of calcium) immediately before a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. After a washout period of at least 3 days, they then tested the Fluoride mouthwash alone, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours.
10798650|NCT04239872|OG000|Outcome|Fluoride Mouthwash|"Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash.~Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase.~This arm refers to the use of the fluoride mouthwash: Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), was used to rinse the mouth for 1 minute and expectorated."
10798651|NCT04239872|OG001|Outcome|Calcium Mouthwash Before Fluoride Mouthwash|"Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash.~Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase.~This arm refers to the use of the calcium mouthwash before the fluoride mouthwash: Calcium lactate, at a concentration of 150 millimolar, was used to rinse the mouth for 1 minute and expectorated; immediately after, a sodium fluoride rinse, at a concentration of 0.05% (226 ppm of fluoride), was used to rinse the mouth for 1 minute, and expectorated."
10798652|NCT04239872|EG000|Reported Event|Fluoride Mouthwash|"Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash.~Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase.~This arm refers to the use of the fluoride mouthwash: Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), was used to rinse the mouth for 1 minute and expectorated."
10798653|NCT04239872|EG001|Reported Event|Calcium Mouthwash Before Fluoride Mouthwash|"Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash.~Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase.~This arm refers to the use of the calcium mouthwash before the fluoride mouthwash: Calcium lactate, at a concentration of 150 millimolar, was used to rinse the mouth for 1 minute and expectorated; immediately after, a sodium fluoride rinse, at a concentration of 0.05% (226 ppm of fluoride), was used to rinse the mouth for 1 minute, and expectorated."
10798654|NCT04141917|BG000|Baseline|Standard Influenza Surveillance Period|"Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.~These are all participants that enrolled when only standard surveillance, no intervention, was available at their shelter given the randomized sequence."
10798655|NCT04141917|BG001|Baseline|Point-of-care Molecular Testing and Treatment of Influenza Period|"Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.~These are all participants that enrolled when both standard surveillance and the intervention was available at their shelter given the randomized sequence."
10798656|NCT04141917|BG002|Baseline|Total|Total of all reporting groups
10803434|NCT04498832|OG000|Outcome|QIV-HD|Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
10803435|NCT04498832|OG001|Outcome|QIV-SD|Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
10803436|NCT04498832|EG000|Reported Event|QIV-HD|Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
10803437|NCT04498832|EG001|Reported Event|QIV-SD|Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
11202330|NCT02207231|EG001|Reported Event|Guselkumab 100 mg (PCP)|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
10798657|NCT04141917|FG000|Participant Flow|Sequence A|"5 months of standard surveillance + test and treat protocol~Standard influenza surveillance period: Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.~Point-of-care molecular testing and treatment of influenza period:~Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798658|NCT04141917|FG001|Participant Flow|Sequence B|"1 month standard surveillance then 4 months standard surveillance + test and treat protocol~Standard influenza surveillance period: Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.~Point-of-care molecular testing and treatment of influenza period:~Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798659|NCT04141917|FG002|Participant Flow|Sequence C|"2 months standard surveillance then 3 months standard surveillance + test and treat protocol~Standard influenza surveillance period: Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.~Point-of-care molecular testing and treatment of influenza period:~Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798660|NCT04141917|FG003|Participant Flow|Sequence D|"3 months standard surveillance then 2 months standard surveillance + test and treat protocol~Standard influenza surveillance period: Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.~Point-of-care molecular testing and treatment of influenza period:~Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798661|NCT04141917|OG000|Outcome|Standard Influenza Surveillance Period|Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.
10798662|NCT04141917|OG001|Outcome|Point-of-care Molecular Testing and Treatment of Influenza Period|"Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798663|NCT04141917|EG000|Reported Event|Standard Influenza Surveillance Period|Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.
10803438|NCT04109222|BG000|Baseline|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803439|NCT04109222|BG001|Baseline|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years|Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10798664|NCT04141917|EG001|Reported Event|Point-of-care Molecular Testing and Treatment of Influenza Period|"Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A & B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .~Point-of-care molecular testing and treatment of influenza: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving."
10798665|NCT04128696|BG000|Baseline|Participants Receiving Feladilimab and Pembrolizumab|Participants were administered feladilimab (GSK3359609-humanized anti-ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798666|NCT04128696|BG001|Baseline|Participants Receiving Placebo and Pembrolizumab|Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798667|NCT04128696|BG002|Baseline|Total|Total of all reporting groups
10798668|NCT04128696|FG000|Participant Flow|Participants Receiving Feladilimab and Pembrolizumab|Participants were administered feladilimab (GSK3359609-humanized anti-ICOS immunoglobulin G4 [IgG4] monoclonal antibody [mAb]) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an intravenous (IV) infusion once every three weeks (Q3W).
10798669|NCT04128696|FG001|Participant Flow|Participants Receiving Placebo and Pembrolizumab|Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798670|NCT04128696|OG000|Outcome|Participants Receiving Feladilimab and Pembrolizumab|Participants were administered feladilimab (GSK3359609-humanized anti-ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798671|NCT04128696|OG001|Outcome|Participants Receiving Placebo and Pembrolizumab|Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798672|NCT04128696|EG000|Reported Event|Participants Receiving Feladilimab and Pembrolizumab|Participants were administered feladilimab (GSK3359609-humanized anti-ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798673|NCT04128696|EG001|Reported Event|Participants Receiving Placebo and Pembrolizumab|Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W.
10798674|NCT04091581|BG000|Baseline|Non-Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled.
10798675|NCT04091581|BG001|Baseline|Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled.
10798676|NCT04091581|BG002|Baseline|Total|Total of all reporting groups
10798677|NCT04091581|FG000|Participant Flow|Non-Dry Eye|Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete was instilled in people with an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye.
10798678|NCT04091581|FG001|Participant Flow|Dry Eye|Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete in people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye.
10798679|NCT04091581|OG000|Outcome|Non-Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled in people without dry eye.
10798680|NCT04091581|OG001|Outcome|Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled in people with dry eye.
10798681|NCT04091581|EG000|Reported Event|Non-Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people without dry eye that had an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye.
10798682|NCT04091581|EG001|Reported Event|Dry Eye|Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people with dry eye that had an Ocular Surface Disease Index score >/=13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye.
10798683|NCT03986671|BG000|Baseline|Normal Subjects|A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI < 2.
10798684|NCT03986671|BG001|Baseline|Amyotrophic Lateral Sclerosis|Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
10798685|NCT03986671|BG002|Baseline|Obstructive Sleep Apnea (OSA)|Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
10798686|NCT03986671|BG003|Baseline|Total|Total of all reporting groups
10798687|NCT03986671|FG000|Participant Flow|Normal Subjects|A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI < 2.
10798688|NCT03986671|FG001|Participant Flow|Amyotrophic Lateral Sclerosis|Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
10798689|NCT03986671|FG002|Participant Flow|Obstructive Sleep Apnea (OSA)|Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
10798690|NCT03986671|OG000|Outcome|Normal Subjects|A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI < 2.
10798691|NCT03986671|OG001|Outcome|Amyotrophic Lateral Sclerosis|Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
10798692|NCT03986671|OG002|Outcome|Obstructive Sleep Apnea (OSA)|Subjects with a confirmed diagnosis of moderate to severe OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
10798693|NCT03986671|EG000|Reported Event|Normal Subjects|A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI < 2.
10798694|NCT03986671|EG001|Reported Event|Amyotrophic Lateral Sclerosis|Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
10798695|NCT03986671|EG002|Reported Event|Obstructive Sleep Apnea (OSA)|Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
10798696|NCT03850535|BG000|Baseline|Dose-Escalation Cohort 1|200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798697|NCT03850535|BG001|Baseline|Dose Escalation Cohort 2|350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798698|NCT03850535|BG002|Baseline|Dose Escalation Cohort 3|250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798699|NCT03850535|BG003|Baseline|Post Consolidation Cohort|150 mg idasanultin day 1 to 5 in maintenance of first remission
10798700|NCT03850535|BG004|Baseline|Total|Total of all reporting groups
10798701|NCT03850535|FG000|Participant Flow|Dose-Escalation Cohort 1|200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798702|NCT03850535|FG001|Participant Flow|Dose Escalation Cohort 2|350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798703|NCT03850535|FG002|Participant Flow|Dose Escalation Cohort 3|250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798704|NCT03850535|FG003|Participant Flow|Post Consolidation Cohort|150 mg idasanultin day 1 to 5 in maintenance of first remission
10798705|NCT03850535|OG000|Outcome|Dose-Escalation Cohort 1|200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798706|NCT03850535|OG001|Outcome|Dose Escalation Cohort 2|350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798707|NCT03850535|OG002|Outcome|Dose Escalation Cohort 3|250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798708|NCT03850535|OG003|Outcome|Post Consolidation Cohort|150 mg idasanultin day 1 to 5 in maintenance of first remission
10798709|NCT03850535|EG000|Reported Event|DOSE ESCALATION COHORT 1|For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin of 200 mg
10798710|NCT03850535|EG001|Reported Event|Dose Escalation Cohort 2|350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798711|NCT03850535|EG002|Reported Event|Dose Escalation Cohort 3|250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
10798712|NCT03850535|EG003|Reported Event|POST CONSOLIDATION PHASE COHORT|Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin of 150 mg
10798713|NCT03839628|BG000|Baseline|Reduced Physical Activity|"Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity~Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity."
10798714|NCT03839628|FG000|Participant Flow|Reduced Physical Activity|"Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity~Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity."
10798715|NCT03839628|OG000|Outcome|Reduced Physical Activity|"Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity~Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity."
10798716|NCT03839628|EG000|Reported Event|Reduced Physical Activity|"Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity~Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity."
10798717|NCT03791398|BG000|Baseline|ONC201 Level 1 (Starting Dose Level)|"625mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose"
10798718|NCT03791398|BG001|Baseline|ONC201 Level 2|"500 mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 2 ONC201 500mg: ONC201 500mg + Nivolumab 240mg IV flat dose"
10798719|NCT03791398|BG002|Baseline|ONC201 Level 3|"375 mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 3 ONC201 375mg: ONC201 375mg + Nivolumab 240mg IV flat dose"
10798720|NCT03791398|BG003|Baseline|Total|Total of all reporting groups
10798721|NCT03791398|FG000|Participant Flow|ONC201 Level 1 (Starting Dose Level)|"625mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose"
10798722|NCT03791398|FG001|Participant Flow|ONC201 Level 2|"500 mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 2 ONC201 500mg: ONC201 500mg + Nivolumab 240mg IV flat dose"
10798723|NCT03791398|FG002|Participant Flow|ONC201 Level 3|"375 mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 3 ONC201 375mg: ONC201 375mg + Nivolumab 240mg IV flat dose"
10798724|NCT03791398|OG000|Outcome|ONC201 Level 1 (Starting Dose Level)|"625mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose"
10798725|NCT03791398|EG000|Reported Event|ONC201 Level 1 (Starting Dose Level)|"625mg ONC201 Cycle 1 Day -7 dose then once week~Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose"
10798726|NCT03759041|BG000|Baseline|Placebo (After Placebo Pre-treatment)|"Once-daily dosing of Placebo (after placebo pre-treatment)~Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment~Placebo for SER-287: Once-daily dosing of Placebo for SER-287"
11241295|NCT02486263|FG001|Participant Flow|Conventional|Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
10798727|NCT03759041|BG001|Baseline|SER-287 Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798728|NCT03759041|BG002|Baseline|SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798729|NCT03759041|BG003|Baseline|Total|Total of all reporting groups
10798730|NCT03759041|FG000|Participant Flow|Placebo (After Placebo Pre-treatment)|"Once-daily dosing of Placebo (after placebo pre-treatment)~Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment~Placebo for SER-287: Once-daily dosing of Placebo for SER-287"
10798731|NCT03759041|FG001|Participant Flow|SER-287 Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798732|NCT03759041|FG002|Participant Flow|SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798733|NCT03759041|OG000|Outcome|Placebo (After Placebo Pre-treatment)|"Once-daily dosing of Placebo (after placebo pre-treatment)~Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment~Placebo for SER-287: Once-daily dosing of Placebo for SER-287"
10798734|NCT03759041|OG001|Outcome|SER-287 Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798735|NCT03759041|OG002|Outcome|SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798736|NCT03759041|EG000|Reported Event|Placebo (After Placebo Pre-treatment)|"Once-daily dosing of Placebo (after placebo pre-treatment)~Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment~Placebo for SER-287: Once-daily dosing of Placebo for SER-287"
10798737|NCT03759041|EG001|Reported Event|SER-287 Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798738|NCT03759041|EG002|Reported Event|SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)|"Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)~Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment~SER-287: Once-daily dosing of SER-287"
10798739|NCT03726879|BG000|Baseline|Atezolizumab +ddAC-PacHP|Participants received atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo was discontinued.
11241296|NCT02486263|OG000|Outcome|Study|"Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions~Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)~Total fluid volume restriction (120-140 milliliters/kilogram/day)~Feeding duration over 30 minutes~Infant feeds with right side down~Infant is placed on back following feeds"
10798740|NCT03726879|BG001|Baseline|Placebo + ddAC-PacHP|Participants received placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo was discontinued.
10798741|NCT03726879|BG002|Baseline|Total|Total of all reporting groups
10798742|NCT03726879|FG000|Participant Flow|Atezolizumab +ddAC-PacHP|Participants received atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo was discontinued.
10803440|NCT04109222|BG002|Baseline|Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years|Participants aged >=65 years received 1 dose of 0.5-mL Fluzone high-dose vaccine intramuscular injection at Day 0.
10803441|NCT04109222|BG003|Baseline|Total|Total of all reporting groups
10798743|NCT03726879|FG001|Participant Flow|Placebo + ddAC-PacHP|Participants received placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo was discontinued.
10798744|NCT03726879|OG000|Outcome|Atezolizumab +ddAC-PacHP|Participants received atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo was discontinued.
10798745|NCT03726879|OG001|Outcome|Placebo + ddAC-PacHP|Participants received placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo was discontinued.
10798746|NCT03726879|EG000|Reported Event|Atezolizumab +ddAC-PacHP|Participants received atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo was discontinued.
10798747|NCT03726879|EG001|Reported Event|Placebo + ddAC-PacHP|Participants received placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants continued to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who did not achieve pCR had option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo was discontinued.
10798748|NCT03726346|BG000|Baseline|Toffee Full Face Mask|"Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.~Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm."
10798749|NCT03726346|FG000|Participant Flow|Toffee Full Face Mask|"Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.~Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm."
10798750|NCT03726346|OG000|Outcome|Toffee Full Face Mask|"Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.~Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm."
10798751|NCT03726346|EG000|Reported Event|Toffee Full Face Mask|"Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.~Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm."
10798752|NCT03714425|BG000|Baseline|High Frequency Device|"Subjects will use high frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798753|NCT03714425|BG001|Baseline|Low Frequency Device|"Subjects will use low frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798754|NCT03714425|BG002|Baseline|Total|Total of all reporting groups
10798755|NCT03714425|FG000|Participant Flow|High Frequency Device|"Subjects will use high frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798756|NCT03714425|FG001|Participant Flow|Low Frequency Device|"Subjects will use low frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798757|NCT03714425|OG000|Outcome|High Frequency Device|"Subjects will use high frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798758|NCT03714425|OG001|Outcome|Low Frequency Device|"Subjects will use low frequency Quell devices.~Quell: Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids."
10798759|NCT03714425|EG000|Reported Event|High Frequency Device|High frequency active device
10798760|NCT03714425|EG001|Reported Event|Low Frequency Device|Low frequency sham device
10798761|NCT03703882|BG000|Baseline|Dose 1|"Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day.~Edasalonexent: 100 mg/kg/day"
10798762|NCT03703882|BG001|Baseline|Placebo|"Matching placebo~Placebo: Placebo"
10798763|NCT03703882|BG002|Baseline|Total|Total of all reporting groups
10798764|NCT03703882|FG000|Participant Flow|Dose 1|"Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day.~Edasalonexent: 100 mg/kg/day"
10798765|NCT03703882|FG001|Participant Flow|Placebo|"Matching placebo~Placebo: Placebo"
10798766|NCT03703882|OG000|Outcome|Dose 1|"Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day.~Edasalonexent: 100 mg/kg/day"
10798767|NCT03703882|OG001|Outcome|Placebo|"Matching placebo~Placebo: Placebo"
10798768|NCT03703882|EG000|Reported Event|Dose 1|"Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day.~Edasalonexent: 100 mg/kg/day"
10798769|NCT03703882|EG001|Reported Event|Placebo|"Matching placebo~Placebo: Placebo"
10798770|NCT03615040|BG000|Baseline|Anti-ST2|"Anti-ST2 (MSTT1041A*) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Anti-ST2 was presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It was formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2.~*Official USAN name for MSTT1041A is now astegolimab"
10798771|NCT03615040|BG001|Baseline|Placebo|"Placebo (no active component) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Placebo for Anti-ST2 (MSTT1041A) was formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and was supplied in an identical vial configuration."
10798772|NCT03615040|BG002|Baseline|Total|Total of all reporting groups
11241297|NCT02486263|OG001|Outcome|Conventional|Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
10798773|NCT03615040|FG000|Participant Flow|Anti-ST2|"Anti-ST2 (MSTT1041A*) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Anti-ST2 was presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It was formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2.~*Official USAN name for MSTT1041A is now astegolimab"
10798774|NCT03615040|FG001|Participant Flow|Placebo|"Placebo (no active component) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Placebo for Anti-ST2 (MSTT1041A) was formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and was supplied in an identical vial configuration."
10798775|NCT03615040|OG000|Outcome|Anti-ST2|"Anti-ST2 (MSTT1041A) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~MSTT1041A: MSTT1041A (RO7187807; formerly made by Amgen [AMG] and referred to as AMG 282) is a novel biopharmaceutical that blocks signaling of interleukin (IL)-33, an inflammatory cytokine of the IL-1 family and member of the newly discovered alarmin class of molecules. IL-33 is released from airway epithelial cells in response to allergens, irritants, and infection. IL-33 release can trigger acute exacerbations in both asthma and COPD. MSTT1041A has the ability to block inflammation,prevent exacerbations, and improve lung function and quality of life.~Anti-ST2 is presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It is formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2."
10798776|NCT03615040|OG001|Outcome|Placebo|"Placebo (no active component) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Placebo: Placebo for Anti-ST2 (MSTT1041A) is formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and is supplied in an identical vial configuration."
10798777|NCT03615040|EG000|Reported Event|Anti-ST2|"Anti-ST2 (MSTT1041A*) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Anti-ST2 was presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It was formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2.~*Official USAN name for MSTT1041A is now astegolimab"
10798778|NCT03615040|EG001|Reported Event|Placebo|"Placebo (no active component) received as subcutaneous injection by infusion pump at 490mg every 4 weeks over a 48 week treatment period.~Placebo for Anti-ST2 (MSTT1041A) was formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and was supplied in an identical vial configuration."
10798779|NCT03611075|BG000|Baseline|Low-Functioning Autism Spectrum Disorder (ASD) Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798780|NCT03611075|BG001|Baseline|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798781|NCT03611075|BG002|Baseline|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798782|NCT03611075|BG003|Baseline|High-Functioning ASD Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798783|NCT03611075|BG004|Baseline|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798784|NCT03611075|BG005|Baseline|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798785|NCT03611075|BG006|Baseline|Healthy Control Participants Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798786|NCT03611075|BG007|Baseline|Healthy Control Participants Adolescence|Participants will be 13-17 years old, with IQ scores of 70 or above
10798787|NCT03611075|BG008|Baseline|Healthy Control Participants Adults|High-Functioning ASD AdultsEdit Participants will be 18-45 years old, with IQ scores of 70 or above
10798788|NCT03611075|BG009|Baseline|Total|Total of all reporting groups
10798789|NCT03611075|FG000|Participant Flow|High-Functioning Autism Spectrum Disorder (ASD) Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798790|NCT03611075|FG001|Participant Flow|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798791|NCT03611075|FG002|Participant Flow|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798792|NCT03611075|FG003|Participant Flow|Low-Functioning Autism Spectrum Disorder (ASD) Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798793|NCT03611075|FG004|Participant Flow|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798794|NCT03611075|FG005|Participant Flow|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798795|NCT03611075|FG006|Participant Flow|Healthy Control Participants Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798796|NCT03611075|FG007|Participant Flow|Healthy Control Participants Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798797|NCT03611075|FG008|Participant Flow|Healthy Control Participants Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798798|NCT03611075|OG000|Outcome|High-Functioning ASD Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798799|NCT03611075|OG001|Outcome|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798800|NCT03611075|OG002|Outcome|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798801|NCT03611075|OG003|Outcome|Low-Functioning ASD Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798802|NCT03611075|OG004|Outcome|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798803|NCT03611075|OG005|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798804|NCT03611075|OG000|Outcome|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798805|NCT03611075|OG001|Outcome|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798806|NCT03611075|OG002|Outcome|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798807|NCT03611075|OG003|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798808|NCT03611075|OG002|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798809|NCT03611075|OG003|Outcome|Low-Functioning Autism Spectrum Disorder (ASD) Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798810|NCT03611075|OG000|Outcome|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798811|NCT03611075|OG001|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798812|NCT03611075|OG002|Outcome|Low-Functioning ASD Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798813|NCT03611075|OG003|Outcome|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798814|NCT03611075|OG000|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798815|NCT03611075|OG002|Outcome|Typically Developing Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798816|NCT03611075|OG004|Outcome|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798817|NCT03611075|OG005|Outcome|Typically Developing Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798818|NCT03611075|OG006|Outcome|Low-Functioning ASD Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798819|NCT03611075|OG007|Outcome|High-Functioning ASD Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798820|NCT03611075|OG008|Outcome|Typically Developing Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798821|NCT03611075|OG002|Outcome|Low-Functioning (ASD Children|Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798822|NCT03611075|OG000|Outcome|High-Functioning ASD Children-1|Participants will be 5-7 years old, with IQ scores of 70 or above
10798823|NCT03611075|OG001|Outcome|High-Functioning ASD Children-2|Participants will be 8-12 years old, with IQ scores of 70 or above
10798824|NCT03611075|OG002|Outcome|High-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798825|NCT03611075|OG003|Outcome|High-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798826|NCT03611075|OG004|Outcome|Low-Functioning ASD Children-1|Participants will be 5-7 years old, with Intelligence Quotient (IQ) scores between 50-70
10798827|NCT03611075|OG005|Outcome|Low-Functioning ASD Children-2|Participants will be 8-12 years old, with Intelligence Quotient (IQ) scores between 50-70
10798828|NCT03611075|OG006|Outcome|Low-Functioning ASD Adolescents|Participants will be 13-17 years old, with IQ scores between 50-70
10798829|NCT03611075|OG007|Outcome|Low-Functioning ASD Adults|Participants will be 18-45 years old, with IQ scores between 50-70
10798830|NCT03611075|EG000|Reported Event|High-Functioning ASD Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798831|NCT03611075|EG001|Reported Event|High-Functioning ASD Adolescent|Participants will be 13-17 years old, with IQ scores of 70 or above
10798832|NCT03611075|EG002|Reported Event|High-Functioning ASD Adults|Participants will be 13-17 years old, with IQ scores of 70 or above
10798833|NCT03611075|EG003|Reported Event|Low-Functioning ASD Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798834|NCT03611075|EG004|Reported Event|Low-Functioning ASD Adolescent|Participants will be 13-17 years old, with IQ scores of 70 or above
10798835|NCT03611075|EG005|Reported Event|Low-Functioning ASD Adults|Participants will be 13-17 years old, with IQ scores of 70 or above
10798836|NCT03611075|EG006|Reported Event|Healthy Control Children|Participants will be 5-12 years old, with IQ scores of 70 or above
10798837|NCT03611075|EG007|Reported Event|Healthy Control Adolescents|Participants will be 13-17 years old, with IQ scores of 70 or above
10798838|NCT03611075|EG008|Reported Event|Healthy Control Adults|Participants will be 18-45 years old, with IQ scores of 70 or above
10798839|NCT03595176|BG000|Baseline|Coronary IVL System (Roll-In)|The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
10798840|NCT03595176|BG001|Baseline|Coronary IVL System (Pivotal)|The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is ongoing.
10798841|NCT03595176|BG002|Baseline|Total|Total of all reporting groups
10798842|NCT03595176|FG000|Participant Flow|Coronary IVL System (Roll-In)|The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
10798843|NCT03595176|FG001|Participant Flow|Coronary IVL System (Pivotal)|The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is ongoing.
10798844|NCT03595176|OG000|Outcome|Coronary IVL System (Pivotal)|The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on pivotal subjects was collected through 30 days for primary endpoints. Long-term follow-up for pivotal subjects to 24 months is ongoing.
10798845|NCT03595176|EG000|Reported Event|Coronary IVL System (Roll-In) Through 30 Days|Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30 days, at which time subject participation was complete.
10798846|NCT03595176|EG001|Reported Event|Coronary IVL System (Pivotal) Through 30 Days|Adverse events reported through 30 days post-procedure for Pivotal subjects. The pivotal analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints.
10798847|NCT03595176|EG002|Reported Event|Coronary IVL System (Pivotal) Through 12 Months|Adverse events reported through 12 months post-procedure for Pivotal subjects. Adverse event data on pivotal subjects was collected through 12 months for long-term follow-up.
10798848|NCT03541317|BG000|Baseline|Stage 1 Strategy: REP:|Stage 1 Strategy: REP. This includes all three arms listed in Participant Flow as not receiving Coaching
10798849|NCT03541317|BG001|Baseline|Stage 1 Strategy: REP + Coaching|Stage 1 Strategy: REP + Coaching This includes all three arms listed in Participant Flow as receiving Coaching.
10798850|NCT03541317|BG002|Baseline|Total|Total of all reporting groups
10798851|NCT03541317|FG000|Participant Flow|REP Only, Responders, Continue|"This group included schools who responded sufficiently to REP only in Stage 1, and then were assigned to Continue REP only in Stage 2."
10798852|NCT03541317|FG001|Participant Flow|REP Only, Non-responders, Continue|"This group included schools who did not respond sufficiently to REP only in Stage 1, and then were assigned to Continue REP only in Stage 2."
10798853|NCT03541317|FG002|Participant Flow|REP Only, Non-responders, Facilitation|"This group included schools who did not respond sufficiently to REP only in Stage 1, and then were assigned to Augment REP with Facilitation in Stage 2."
10798854|NCT03541317|FG003|Participant Flow|REP + Coaching, Responders, Continue|"This group included schools who responded sufficiently to REP + Coaching in Stage 1, and then were assigned to Continue REP + Coaching in Stage 2."
10798855|NCT03541317|FG004|Participant Flow|REP + Coaching, Non-responders, Continue|"This group included schools who did not respond sufficiently to REP + Coaching in Stage 1, and then were assigned to Continue REP + Coaching in Stage 2."
10798856|NCT03541317|FG005|Participant Flow|REP + Coaching, Non-responders, Facilitation|"This group included schools who did not respond sufficiently to REP + Coaching in Stage 1, and then were assigned to Augment REP + Coaching with Facilitation in Stage 2."
10798857|NCT03541317|OG000|Outcome|Group 1: REP Only|"This arm consists of only those professionals in schools that received REP only: including those who were originally randomized to receive REP only and never re-randomized to receive facilitation (responders to REP) and those who were non-responders to REP but randomized to continue with REP only in Stage 2. Thus, it corresponds in Participant Flow to both the REP only, Responders Continue and REP Only, Non-Responders Continue. The 43 professionals represent 26 schools."
10798858|NCT03541317|OG001|Outcome|Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation|"This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive Facilitation in Stage 2. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator.~Thus, this arm represents REP + Coaching Responders, Continue and REP + Coaching, Non-Responders, Facilitation from the Participant Flow. The 45 professionals represent 26 schools."
11202331|NCT02207231|EG002|Reported Event|Adalimumab (PCP)|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.
10798859|NCT03541317|OG000|Outcome|Group 1: REP Only|"This arm consists of only those professionals in schools that received REP only: including those who were originally randomized to receive REP only and never re-randomized to receive facilitation (Responders to REP) and those who were Non-Responders to REP but randomized to continue with REP only in Stage 2. Thus, it corresponds in Participant Flow to both the REP only, Responders Continue and REP Only, Non-Responders Continue. The 43 professionals represent 26 schools."
10798860|NCT03541317|OG001|Outcome|Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation|"This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive Facilitation in Stage 2. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator.~Thus, this arm represents REP + Coaching Responders and REP + Coaching with Facilitation from the Participant Flow. The 45 professionals represent 26 schools."
10798861|NCT03541317|EG000|Reported Event|REP Only, Responders, Continue|"This group included schools who responded sufficiently to REP only in Stage 1, and then were assigned to continue REP only in Stage 2."
10798862|NCT03541317|EG001|Reported Event|REP Only, Non-Responders, Continue|"This group included schools who did not respond sufficiently to REP only in Stage 1, and were assigned to continue REP only in Stage 2."
10798863|NCT03541317|EG002|Reported Event|REP Only, Non-Responders, Facilitation|"This group included schools who did not respond sufficiently to REP only in Stage 1, and then were assigned to augment REP with Facilitation in Stage 2."
10798864|NCT03541317|EG003|Reported Event|REP + Coaching Responders, Continue|"This group included schools who responded sufficiently to REP + Coaching in Stage 1 and were assigned to continue REP + Coaching in Stage 2."
10798865|NCT03541317|EG004|Reported Event|REP+ Coaching Non-Responders, Continue|"This group included schools who did not respond sufficiently to REP + Coaching in Stage 1 and were assigned to continue REP + Coaching in Stage 2."
10798866|NCT03541317|EG005|Reported Event|REP + Coaching, Non-Responders, Facilitation|"This group included schools who did not respond sufficiently to REP + Coaching in Stage 1, and then were assigned to augment REP+ Coaching with Facilitation in Stage 2."
11196491|NCT02164929|EG000|Reported Event|Paravertebral Block|"Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).~Paravertebral block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
10798867|NCT03523117|BG000|Baseline|Ferric Caroboxymaltose|"Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.~Ferric carboxymaltose: Intravenous iron"
10798868|NCT03523117|BG001|Baseline|Oral Ferrous Sulfate|"Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron.~Ferrous Sulfate: oral iron therapy"
10798869|NCT03523117|BG002|Baseline|Total|Total of all reporting groups
10798870|NCT03523117|FG000|Participant Flow|Ferric Caroboxymaltose|"Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.~Ferric carboxymaltose: Intravenous iron"
10798871|NCT03523117|FG001|Participant Flow|Oral Ferrous Sulfate|"Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron.~Ferrous Sulfate: oral iron therapy"
10798872|NCT03523117|OG000|Outcome|Ferric Caroboxymaltose|"Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.~Ferric carboxymaltose: Intravenous iron"
10798873|NCT03523117|OG001|Outcome|Oral Ferrous Sulfate|"Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron.~Ferrous Sulfate: oral iron therapy"
10798874|NCT03523117|EG000|Reported Event|Ferric Caroboxymaltose|"Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.~Ferric carboxymaltose: Intravenous iron"
10798875|NCT03523117|EG001|Reported Event|Oral Ferrous Sulfate|"Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron.~Ferrous Sulfate: oral iron therapy"
10798876|NCT03412565|BG000|Baseline|Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
10798877|NCT03412565|BG001|Baseline|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
10798878|NCT03412565|BG002|Baseline|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798879|NCT03412565|BG003|Baseline|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798880|NCT03412565|BG004|Baseline|Total|Total of all reporting groups
10798881|NCT03412565|FG000|Participant Flow|Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
11196492|NCT02164929|EG001|Reported Event|TAP Block|"Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~TAP block~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
10798882|NCT03412565|FG001|Participant Flow|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
10798883|NCT03412565|FG002|Participant Flow|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798884|NCT03412565|FG003|Participant Flow|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798885|NCT03412565|OG000|Outcome|Daratumumab (D) + Bortezomib + Melphalan + Prednisone (D-VMP)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
10798886|NCT03412565|OG001|Outcome|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798887|NCT03412565|OG002|Outcome|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798888|NCT03412565|OG000|Outcome|Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
10798889|NCT03412565|OG001|Outcome|D-VMP|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
10798890|NCT03412565|OG002|Outcome|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798891|NCT03412565|OG003|Outcome|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798892|NCT03412565|OG000|Outcome|D-VMP|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
11196493|NCT02164929|EG002|Reported Event|Epidural|"An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).~A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.~Epidural~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropi"
10798893|NCT03412565|OG000|Outcome|D-VMP|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
10798894|NCT03412565|EG000|Reported Event|Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
10798895|NCT03412565|EG001|Reported Event|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
11202332|NCT02207231|EG003|Reported Event|Placebo Then Guselkumab 100 mg (ACP)|Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).
11337842|NCT03595280|OG002|Outcome|Tailored Messages|"Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
11337843|NCT03595280|EG000|Reported Event|Control|Participants in the control group receive no study messages
11337844|NCT03595280|EG001|Reported Event|Untailored Messages|"Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
11337845|NCT03595280|EG002|Reported Event|Tailored Messages|"Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs.~Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use."
11337846|NCT03595449|BG000|Baseline|Lidocaine Jelly|"This group had lidocaine jelly applied during Mohs surgery~Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery"
11337847|NCT03595449|BG001|Baseline|Surgilube|"This group had surgilube (placebo) applied during Mohs surgery~Surgilube: surgilube (placebo) applied during Mohs surgery"
11337848|NCT03595449|BG002|Baseline|Total|Total of all reporting groups
11337849|NCT03595449|FG000|Participant Flow|Lidocaine Jelly|"This group had lidocaine jelly applied during Mohs surgery~Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery"
11337850|NCT03595449|FG001|Participant Flow|Surgilube|"This group had surgilube (placebo) applied during Mohs surgery~Surgilube: surgilube (placebo) applied during Mohs surgery"
11337851|NCT03595449|OG000|Outcome|Lidocaine Jelly|"This group had lidocaine jelly applied during Mohs surgery~Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery"
11337852|NCT03595449|OG001|Outcome|Surgilube|"This group had surgilube (placebo) applied during Mohs surgery~Surgilube: surgilube (placebo) applied during Mohs surgery"
11337853|NCT03595449|EG000|Reported Event|Lidocaine Jelly|"This group had lidocaine jelly applied during Mohs surgery~Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery"
11337854|NCT03595449|EG001|Reported Event|Surgilube|"This group had surgilube (placebo) applied during Mohs surgery~Surgilube: surgilube (placebo) applied during Mohs surgery"
11337855|NCT03595579|BG000|Baseline|AXS-05|AXS-05: AXS-05 taken twice daily for 6 weeks.
11337856|NCT03595579|BG001|Baseline|Bupropion|Bupropion: Bupropion taken twice daily for 6 weeks.
11337857|NCT03595579|BG002|Baseline|Total|Total of all reporting groups
11337858|NCT03595579|FG000|Participant Flow|AXS-05|AXS-05: AXS-05 taken twice daily for 6 weeks.
11337859|NCT03595579|FG001|Participant Flow|Bupropion|Bupropion: Bupropion taken twice daily for 6 weeks.
11337860|NCT03595579|OG000|Outcome|AXS-05|AXS-05: AXS-05 taken twice daily for 6 weeks.
11337861|NCT03595579|OG001|Outcome|Bupropion|Bupropion: Bupropion taken twice daily for 6 weeks.
11337862|NCT03595579|EG000|Reported Event|AXS-05|AXS-05: AXS-05 taken twice daily for 6 weeks.
11337863|NCT03595579|EG001|Reported Event|Bupropion|Bupropion: Bupropion taken twice daily for 6 weeks.
11337864|NCT03595618|BG000|Baseline|GLPG1972 75 mg|Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337865|NCT03595618|BG001|Baseline|GLPG1972 150 mg|Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337866|NCT03595618|BG002|Baseline|GLPG1972 300 mg|Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
11337867|NCT03595618|BG003|Baseline|Placebo|Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
11337868|NCT03595618|BG004|Baseline|Total|Total of all reporting groups
11337869|NCT03595618|FG000|Participant Flow|GLPG1972 75 mg|Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337870|NCT03595618|FG001|Participant Flow|GLPG1972 150 mg|Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337871|NCT03595618|FG002|Participant Flow|GLPG1972 300 mg|Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
11337872|NCT03595618|FG003|Participant Flow|Placebo|Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
11337873|NCT03595618|OG000|Outcome|GLPG1972 75 mg|Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337874|NCT03595618|OG001|Outcome|GLPG1972 150 mg|Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
11337875|NCT03595618|OG002|Outcome|GLPG1972 300 mg|Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
11337876|NCT03595618|OG003|Outcome|Placebo|Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
11337877|NCT03595618|EG000|Reported Event|GLPG1972 75 mg|Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
10798896|NCT03412565|EG002|Reported Event|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798897|NCT03412565|EG003|Reported Event|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)|Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
10798898|NCT03400943|BG000|Baseline|Vilaprisan (A1)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798899|NCT03400943|BG001|Baseline|Vilaprisan (A2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
10798900|NCT03400943|BG002|Baseline|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798901|NCT03400943|BG003|Baseline|Vilaprisan+Placebo (B2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798902|NCT03400943|BG004|Baseline|Total|Total of all reporting groups
10798903|NCT03400943|FG000|Participant Flow|Vilaprisan (A1)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798904|NCT03400943|FG001|Participant Flow|Vilaprisan (A2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
10798905|NCT03400943|FG002|Participant Flow|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798906|NCT03400943|FG003|Participant Flow|Vilaprisan+Placebo (B2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798907|NCT03400943|OG000|Outcome|Vilaprisan (A1)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798908|NCT03400943|OG001|Outcome|Vilaprisan (A2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
10798909|NCT03400943|OG002|Outcome|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798910|NCT03400943|OG003|Outcome|Vilaprisan+Placebo (B2)|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798911|NCT03400943|EG000|Reported Event|Vilaprisan - Treatment Emergent AEs|Participants who received the treatment of Vilaprisan in the study.
10798912|NCT03400943|EG001|Reported Event|Placebo - Treatment Emergent AEs|Participants who received placebo in the study.
10798913|NCT03400943|EG002|Reported Event|Vilaprisan (A1) - Post Treatment AEs|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798914|NCT03400943|EG003|Reported Event|Vilaprisan (A2) - Post Treatment AEs|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
10798915|NCT03400943|EG004|Reported Event|Placebo+ Vilaprisan (B1) - Post Treatment AEs|Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11384365|NCT01923168|FG002|Participant Flow|Placebo + Letrozole|Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
10798916|NCT03400943|EG005|Reported Event|Vilaprisan+ Placebo (B2) - Post Treatment AEs|Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
10798917|NCT03396952|BG000|Baseline|Treatment (Pembrolizumab, Ipilimumab, Aspirin)|"Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Aspirin: Given PO~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
10798918|NCT03396952|FG000|Participant Flow|Treatment (Pembrolizumab, Ipilimumab, Aspirin)|"Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin orally, twice a day (PO BID) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Aspirin: Given orally (PO)~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
10798919|NCT03396952|OG000|Outcome|Treatment (Pembrolizumab, Ipilimumab, Aspirin)|"Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Aspirin: Given PO~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11384366|NCT01923168|OG000|Outcome|Alpelisib + Letrozole|Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
11384367|NCT01923168|OG001|Outcome|Placebo + Letrozole|Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
11384368|NCT01923168|OG000|Outcome|Buparlisib + Letrozole|Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
11384369|NCT01923168|EG000|Reported Event|Alpelisib + Letrozole|Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
10798920|NCT03396952|EG000|Reported Event|Treatment (Pembrolizumab, Ipilimumab, Aspirin)|"Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Aspirin: Given PO~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
10798938|NCT03302234|BG000|Baseline|Pembrolizumab + Ipilimumab|Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798939|NCT03302234|BG001|Baseline|Pembrolizumab + Placebo|Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798940|NCT03302234|BG002|Baseline|Total|Total of all reporting groups
10798941|NCT03302234|FG000|Participant Flow|Pembrolizumab + Ipilimumab|Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798942|NCT03302234|FG001|Participant Flow|Pembrolizumab + Placebo|Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798943|NCT03302234|OG000|Outcome|Pembrolizumab + Ipilimumab|Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
11196494|NCT02164929|EG003|Reported Event|No Block (PCA Alone)|"Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure~Acetaminophen 1g IV~Dexamethasone 4mg~Midazolam up to 2mg~Propofol 1-2.5 mg/kg~Sevoflurane to keep a bispectral index of between 40-60~Local infiltration with 10 mL of plain ropivacaine 0.25%"
11196495|NCT02164981|BG000|Baseline|Drug - Drug|"Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)"
11196496|NCT02164981|BG001|Baseline|Placebo - Drug|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)"
11384370|NCT01923168|EG001|Reported Event|Buparlisib + Letrozole|Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
11384371|NCT01923168|EG002|Reported Event|Placebo + Letrozole|Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
11384372|NCT01923480|BG000|Baseline|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11384373|NCT01923480|BG001|Baseline|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11384374|NCT01923480|BG002|Baseline|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11384375|NCT01923480|BG003|Baseline|Total|Total of all reporting groups
11384376|NCT01923480|FG000|Participant Flow|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid) Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384377|NCT01923480|FG001|Participant Flow|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384378|NCT01923480|FG002|Participant Flow|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384379|NCT01923480|FG003|Participant Flow|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11196497|NCT02164981|BG002|Baseline|Placebo - Placebo|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2)."
11196498|NCT02164981|BG003|Baseline|Total|Total of all reporting groups
11196499|NCT02164981|FG000|Participant Flow|Drug - Drug|"Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)"
11196500|NCT02164981|FG001|Participant Flow|Placebo - Drug|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)"
11196501|NCT02164981|FG002|Participant Flow|Placebo - Placebo|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2)."
11196502|NCT02164981|OG000|Outcome|Drug|"Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11196503|NCT02164981|OG001|Outcome|Placebo|"Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose~Placebo:"
11384380|NCT01923480|FG004|Participant Flow|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384381|NCT01923480|FG005|Participant Flow|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384382|NCT01923480|OG000|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11196504|NCT02164981|OG000|Outcome|Drug|"Phase 1 - intravenous sodium Nitroprusside or placebo Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11384383|NCT01923480|OG001|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384384|NCT01923480|OG002|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384385|NCT01923480|OG003|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)"
11384386|NCT01923480|OG004|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384387|NCT01923480|OG005|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384388|NCT01923480|OG003|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
11384389|NCT01923480|EG000|Reported Event|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11384390|NCT01923480|EG001|Reported Event|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11384391|NCT01923480|EG002|Reported Event|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
11196505|NCT02164981|OG001|Outcome|Placebo - Placebo|"Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose~Placebo:"
11196506|NCT02164981|OG000|Outcome|Drug - Drug|"Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11384392|NCT01931098|BG000|Baseline|Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384393|NCT01931098|BG001|Baseline|Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384394|NCT01931098|BG002|Baseline|Total|Total of all reporting groups
11384395|NCT01931098|FG000|Participant Flow|Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384396|NCT01931098|FG001|Participant Flow|Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384397|NCT01931098|OG000|Outcome|Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384398|NCT01931098|OG001|Outcome|Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384399|NCT01931098|OG000|Outcome|Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure|Participants received imaging and corresponding MDSAI-BT at baseline and even-numbered cycles.
11384400|NCT01931098|OG001|Outcome|Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure|Participants received imaging and corresponding MDSAI-BT at baseline and cycle 1 thru cycle 3, and subsequent odd-numbered cycles.
11384401|NCT01931098|EG000|Reported Event|Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384402|NCT01931098|EG001|Reported Event|Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure|"Topotecan and pazopanib are administered orally daily.~topotecan: Taken .25 mg orally, daily continuous until progression up to one year.~pazopanib: 600 mg orally, daily until progression, up to one year."
11384403|NCT01945021|BG000|Baseline|Crizotinib 250 mg|Participants received crizotinib 250 mg orally twice a day in a cycle of 28 days. Dose was modified by investigator if there was treatment-related toxicity. Maximum treatment exposure time was of 291.9 weeks up to final analysis date.
11384404|NCT01945021|FG000|Participant Flow|Crizotinib 250 mg|Participants received crizotinib 250 mg orally twice a day in a cycle of 28 days. Dose was modified by investigator if there was treatment-related toxicity. Maximum treatment exposure time was of 291.9 weeks up to final analysis date.
11384405|NCT01945021|OG000|Outcome|Crizotinib 250 mg|Participants received crizotinib 250 mg orally twice a day in a cycle of 28 days. Dose was modified by investigator if there was treatment-related toxicity. Maximum treatment exposure time was of 291.9 weeks up to final analysis date.
11384406|NCT01945021|EG000|Reported Event|Crizotinib 250 mg|Participants received crizotinib 250 mg orally twice a day in a cycle of 28 days. Dose was modified by investigator if there was treatment-related toxicity. Maximum treatment exposure time was of 291.9 weeks up to final analysis date.
11384407|NCT04747808|BG000|Baseline|LL-BMT1|"Group 4 extended-wear contact lens printed with bimatoprost~LL-BMT1: Drug-printed contact lens in both eyes"
11196507|NCT02164981|OG001|Outcome|Placebo - Drug|"Phase 1 - intravenous dextrose Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11196508|NCT02164981|OG002|Outcome|Placebo - Placebo|"Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose~Placebo: Placebo"
11196509|NCT02164981|OG000|Outcome|Drug-Drug|"Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11384408|NCT04747808|FG000|Participant Flow|LL-BMT1|"Group 4 extended-wear contact lens printed with bimatoprost~LL-BMT1: Drug-printed contact lens in both eyes"
11384409|NCT04747808|OG000|Outcome|LL-BMT1|"Group 4 extended-wear contact lens printed with bimatoprost~LL-BMT1: Drug-printed contact lens in both eyes"
11384410|NCT04747808|EG000|Reported Event|LL-BMT1|"Group 4 extended-wear contact lens printed with bimatoprost~LL-BMT1: Drug-printed contact lens in both eyes"
11384411|NCT04466384|BG000|Baseline|Randomized Study Participants|Baseline measures are reported for subjects who were enrolled and randomized to Propofol first or First Propofol with Remifentanil arms (n=24). Baseline measurements are not reported for subjects who were screen failures (n=6) or withdrawn due to safety events (n=4).
11384412|NCT04466384|FG000|Participant Flow|Propofol First|Participants first received two regimens of Propofol (first phase). After a 1-week washout period, then received two regimens of Propofol with 4 ng/ml Remifentanil (cross over phase).
11384413|NCT04466384|FG001|Participant Flow|First Propofol With Remifentanil|Participants first received two regimens of Propofol with 4 ng/ml Remifentanil (first phase). After a 1-week washout period, then received two regimens of Propofol (cross over phase).
10803442|NCT04109222|FG000|Participant Flow|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months|Participants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.
11196510|NCT02164981|OG001|Outcome|Placebo-Drug|Phase 1 - intravenous dextrose Phase 2 - intravenous sodium nitroprusside
11196511|NCT02164981|OG002|Outcome|Placebo - Placebo|"Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose~Placebo:"
11196512|NCT02164981|OG000|Outcome|Drug - Drug|"Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)"
10798944|NCT03302234|OG001|Outcome|Pembrolizumab + Placebo|Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798945|NCT03302234|EG000|Reported Event|Pembrolizumab + Ipilimumab (First Course)|Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798946|NCT03302234|EG001|Reported Event|Pembrolizumab + Placebo (First Course)|Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only.
10798947|NCT03302234|EG002|Reported Event|Pembrolizumab + Placebo (Second Course)|Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).
10798948|NCT03292588|BG000|Baseline|Mepolizumab|"Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment.~Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
10798949|NCT03292588|BG001|Baseline|Placebo|"Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment.~Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
10798950|NCT03292588|BG002|Baseline|Total|Total of all reporting groups
10798951|NCT03292588|FG000|Participant Flow|Mepolizumab|"Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment.~Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
10798952|NCT03292588|FG001|Participant Flow|Placebo|"Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment.~Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
11196513|NCT02164981|OG001|Outcome|Placebo - Drug|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)"
10798953|NCT03292588|OG000|Outcome|Mepolizumab|"Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment.~Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
10798954|NCT03292588|OG001|Outcome|Placebo|"Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment.~Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of:~100 mg for participants ≥12 years of age and~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
11196514|NCT02164981|OG002|Outcome|Placebo - Placebo|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2)."
11196515|NCT02164981|OG000|Outcome|Drug - Drug|"Phase 1 - intravenous sodium Nitroprusside (SNP) Phase 2 - intravenous sodium Nitroprusside (SNP)~Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 and Day 14"
10798955|NCT03292588|OG000|Outcome|Mepolizumab|Mepolizumab (anti-IL-5 antagonist monoclonal antibody) by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
10798956|NCT03292588|OG001|Outcome|Placebo|Placebo by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
10798957|NCT03292588|EG000|Reported Event|Mepolizumab|Mepolizumab (anti-IL-5 antagonist monoclonal antibody) by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
10798958|NCT03292588|EG001|Reported Event|Placebo|Placebo by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
10798959|NCT03277105|BG000|Baseline|Daratumumab IV|Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798960|NCT03277105|BG001|Baseline|Daratumumab SC|Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798961|NCT03277105|BG002|Baseline|Total|Total of all reporting groups
10798962|NCT03277105|FG000|Participant Flow|Daratumumab IV|Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798963|NCT03277105|FG001|Participant Flow|Daratumumab SC|Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798964|NCT03277105|OG000|Outcome|Daratumumab IV|Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798965|NCT03277105|OG001|Outcome|Daratumumab SC|Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798966|NCT03277105|EG000|Reported Event|Daratumumab IV|Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798967|NCT03277105|EG001|Reported Event|Daratumumab SC|Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
10798968|NCT03272763|BG000|Baseline|F&P Toffee Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.~F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes."
10798969|NCT03272763|FG000|Participant Flow|F&P Toffee Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.~F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes."
10798970|NCT03272763|OG000|Outcome|F&P Toffee Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.~F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes."
10798971|NCT03272763|EG000|Reported Event|F&P Toffee Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.~F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes."
10798972|NCT03251326|BG000|Baseline|Nabilone/Propranolol/Placebo + Smoked Cannabis/Placebo Placebo|Nabilone capsules (4 mg) Propranolol (40mg) Placebo (0mg nabilone or propranolol) Placebo cannabis (0.0% THC) Smoked cannabis (5.6% THC)
10798973|NCT03251326|FG000|Participant Flow|Active Nab > Plac Prop > Plac Cann|Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798974|NCT03251326|FG001|Participant Flow|Plac Nab > Act Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)
10798975|NCT03251326|FG002|Participant Flow|Plac Nab > Plac Prop > Act Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)
10798976|NCT03251326|FG003|Participant Flow|Plac Nab > Plac Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798977|NCT03251326|OG000|Outcome|Active Nab > Plac Prop > Plac Cann|Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798978|NCT03251326|OG001|Outcome|Plac Nab > Act Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)
10798979|NCT03251326|OG002|Outcome|Plac Nab > Plac Prop > Act Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)
10798980|NCT03251326|OG003|Outcome|Plac Nab > Plac Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798981|NCT03251326|EG000|Reported Event|Active Nab > Plac Prop > Plac Cann|Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798982|NCT03251326|EG001|Reported Event|Plac Nab > Act Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)
10798983|NCT03251326|EG002|Reported Event|Plac Nab > Plac Prop > Act Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)
10798984|NCT03251326|EG003|Reported Event|Plac Nab > Plac Prop > Plac Cann|Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
10798985|NCT03232346|BG000|Baseline|Regimen 1|"Rapid Monday to Friday oral naltrexone-induction procedure~Vivitrol: Oral naltrexone induction procedure followed by Vivitrol"
10798986|NCT03232346|BG001|Baseline|Regimen 2|"5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg~Buprenorphine: 5-week buprenorphine taper"
10798987|NCT03232346|BG002|Baseline|Total|Total of all reporting groups
10798988|NCT03232346|FG000|Participant Flow|Regimen 1|"Rapid Monday to Friday oral naltrexone-induction procedure~Vivitrol: Oral naltrexone induction procedure followed by Vivitrol"
10798989|NCT03232346|FG001|Participant Flow|Regimen 2|"5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg~Buprenorphine: 5-week buprenorphine taper"
10798990|NCT03232346|OG000|Outcome|Regimen 1|"Rapid Monday to Friday oral naltrexone-induction procedure~Vivitrol: Oral naltrexone induction procedure followed by Vivitrol"
10798991|NCT03232346|OG001|Outcome|Regimen 2|"5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg~Buprenorphine: 5-week buprenorphine taper"
10798992|NCT03232346|EG000|Reported Event|Regimen 1|"Rapid Monday to Friday oral naltrexone-induction procedure~Vivitrol: Oral naltrexone induction procedure followed by Vivitrol"
11337878|NCT03595618|EG001|Reported Event|GLPG1972 150 mg|Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
10798993|NCT03232346|EG001|Reported Event|Regimen 2|"5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg~Buprenorphine: 5-week buprenorphine taper"
10798994|NCT03208244|BG000|Baseline|Treatment With Direct Acting Antiviral for HCV|"12 weeks of treatment with HCV Direct Acting Antiviral tablet~Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks"
10798995|NCT03208244|FG000|Participant Flow|Treatment With Direct Acting Antiviral for HCV|"12 weeks of treatment with HCV Direct Acting Antiviral tablet~Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks"
10798996|NCT03208244|OG000|Outcome|Treatment With Direct Acting Antiviral for HCV|"12 weeks of treatment with HCV Direct Acting Antiviral tablet~Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks"
10798997|NCT03208244|EG000|Reported Event|Treatment With Direct Acting Antiviral for HCV|"12 weeks of treatment with HCV Direct Acting Antiviral tablet~Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks"
10798998|NCT03201965|BG000|Baseline|Run-In: Daratumumab Plus CyBorD|Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment.
10798999|NCT03201965|BG001|Baseline|CyBorD|Participants received dexamethasone (40 mg weekly dose) in every 28-day cycle followed by cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m^2 SC injection once weekly for a maximum of 6 cycles (24 weeks). All cycles were of 28 days.
10799000|NCT03201965|BG002|Baseline|Daratumumab Plus CyBorD|Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly in cycles 1 and 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 24 months from the first dose of study treatment. All cycles were of 28 days.
10799001|NCT03201965|BG003|Baseline|Total|Total of all reporting groups
10799002|NCT03201965|FG000|Participant Flow|Run-In: Daratumumab Plus CyBorD|Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment.
10799003|NCT03201965|FG001|Participant Flow|CyBorD|Participants received dexamethasone (40 mg weekly dose) in every 28-day cycle followed by cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m^2 SC injection once weekly for a maximum of 6 cycles (24 weeks). All cycles were of 28 days.
10799004|NCT03201965|FG002|Participant Flow|Daratumumab Plus CyBorD|Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly in cycles 1 and 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 24 months from the first dose of study treatment. All cycles were of 28 days.
10799005|NCT03201965|OG000|Outcome|CyBorD|Participants received dexamethasone (40 mg weekly dose) in every 28-day cycle followed by cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m^2 SC injection once weekly for a maximum of 6 cycles (24 weeks). All cycles were of 28 days.
10799006|NCT03201965|OG001|Outcome|Daratumumab Plus CyBorD|Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly in cycles 1 and 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 24 months from the first dose of study treatment. All cycles were of 28 days.
10799007|NCT03201965|EG000|Reported Event|Run-In: Daratumumab Plus CyBorD|Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment.
10799008|NCT03201965|EG001|Reported Event|CyBorD|Participants received dexamethasone (40 mg weekly dose) in every 28-day cycle followed by cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m^2 SC injection once weekly for a maximum of 6 cycles (24 weeks). All cycles were of 28 days.
10799009|NCT03201965|EG002|Reported Event|Daratumumab Plus CyBorD|Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly in cycles 1 and 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 24 months from the first dose of study treatment. All cycles were of 28 days.
10799010|NCT03187379|BG000|Baseline|Exparel, Liposomal Bupivacaine|"Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing~Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine"
10799011|NCT03187379|BG001|Baseline|Control|"Subjects in this arm will receive 0.25% bupivacaine alone~Bupivacaine: 60cc Bupivacaine"
10799012|NCT03187379|BG002|Baseline|Total|Total of all reporting groups
10799013|NCT03187379|FG000|Participant Flow|Exparel, Liposomal Bupivacaine|"Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing~Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine"
10799014|NCT03187379|FG001|Participant Flow|Control|"Subjects in this arm will receive 0.25% bupivacaine alone~Bupivacaine: 60cc Bupivacaine"
10799015|NCT03187379|OG000|Outcome|Exparel, Liposomal Bupivacaine|"Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing~Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine"
10799016|NCT03187379|OG001|Outcome|Control|"Subjects in this arm will receive 0.25% bupivacaine alone~Bupivacaine: 60cc Bupivacaine"
10799017|NCT03187379|EG000|Reported Event|Exparel, Liposomal Bupivacaine|"Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing~Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine"
10799018|NCT03187379|EG001|Reported Event|Control|"Subjects in this arm will receive 0.25% bupivacaine alone~Bupivacaine: 60cc Bupivacaine"
10799019|NCT03122886|BG000|Baseline|Group I (Fat Emulsion)|Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
11196516|NCT02164981|OG001|Outcome|Placebo - Drug|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (SNP)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14"
10799020|NCT03122886|BG001|Baseline|Group II (Placebo)|Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799021|NCT03122886|BG002|Baseline|Total|Total of all reporting groups
10799022|NCT03122886|FG000|Participant Flow|Group I (Fat Emulsion)|Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799023|NCT03122886|FG001|Participant Flow|Group II (Placebo)|Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799024|NCT03122886|OG000|Outcome|Group I (Fat Emulsion)|Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799025|NCT03122886|OG001|Outcome|Group II (Placebo)|Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799026|NCT03122886|EG000|Reported Event|Group I (Fat Emulsion)|Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799027|NCT03122886|EG001|Reported Event|Group II (Placebo)|Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
10799028|NCT03077360|BG000|Baseline|Weight Loss Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799029|NCT03077360|BG001|Baseline|Exercise Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799030|NCT03077360|BG002|Baseline|Delayed Intervention Control|Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
10799031|NCT03077360|BG003|Baseline|Total|Total of all reporting groups
10799032|NCT03077360|FG000|Participant Flow|Weight Loss Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799033|NCT03077360|FG001|Participant Flow|Exercise Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799034|NCT03077360|FG002|Participant Flow|Delayed Intervention Control|Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
10799035|NCT03077360|OG000|Outcome|Weight Loss Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799036|NCT03077360|OG001|Outcome|Exercise Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799037|NCT03077360|OG002|Outcome|Delayed Intervention Control|Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
10799038|NCT03077360|OG002|Outcome|Delayed Intervention Control|Free living control group which performed intervention of their choice after finishing
10799039|NCT03077360|EG000|Reported Event|Weight Loss Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799040|NCT03077360|EG001|Reported Event|Exercise Only|Lifestyle: Lifestyle changes to lose weight or become more fit
10799041|NCT03077360|EG002|Reported Event|Delayed Intervention Control|Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
10799042|NCT03050060|BG000|Baseline|Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)|"Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution.~Atezolizumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Nelfinavir Mesylate: Given PO~Nivolumab: Given IV~Pembrolizumab: Given IV"
10799043|NCT03050060|FG000|Participant Flow|Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)|"Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution.~Atezolizumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Nelfinavir Mesylate: Given PO~Nivolumab: Given IV~Pembrolizumab: Given IV"
10799044|NCT03050060|OG000|Outcome|Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)|"Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution.~Atezolizumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Nelfinavir Mesylate: Given PO~Nivolumab: Given IV~Pembrolizumab: Given IV"
10799045|NCT03050060|EG000|Reported Event|Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)|"Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution.~Atezolizumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Nelfinavir Mesylate: Given PO~Nivolumab: Given IV~Pembrolizumab: Given IV"
10799046|NCT02968381|BG000|Baseline|Imagery Intervention|"Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.~Imagery Intervention: Telephone coaching sessions, use of guided imagery and website."
10799047|NCT02968381|BG001|Baseline|Control Condition|"Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.~Control Condition: Telephone coaching using standard cognitive behavioral methods"
10799048|NCT02968381|BG002|Baseline|Total|Total of all reporting groups
11196517|NCT02164981|OG002|Outcome|Placebo - Placebo|"Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)~Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 and again at Day 14."
10799049|NCT02968381|FG000|Participant Flow|Imagery Intervention|"Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.~Imagery Intervention: Telephone coaching sessions, use of guided imagery and website."
10799050|NCT02968381|FG001|Participant Flow|Control Condition|"Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.~Control Condition: Telephone coaching using standard cognitive behavioral methods"
10799051|NCT02968381|OG000|Outcome|Imagery Intervention|"Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.~Imagery Intervention: Telephone coaching sessions, use of guided imagery and website."
10799052|NCT02968381|OG001|Outcome|Control Condition|"Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.~Control Condition: Telephone coaching using standard cognitive behavioral methods"
10799053|NCT02968381|EG000|Reported Event|Imagery Intervention|"Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.~Imagery Intervention: Telephone coaching sessions, use of guided imagery and website."
10799054|NCT02968381|EG001|Reported Event|Control Condition|"Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.~Control Condition: Telephone coaching using standard cognitive behavioral methods"
10799055|NCT02847637|BG000|Baseline|C: No Prophylaxis|Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis.
10799056|NCT02847637|BG001|Baseline|A: Emicizumab 1.5 mg/kg/Week|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799057|NCT02847637|BG002|Baseline|B: Emicizumab 3 mg/kg/2 Weeks|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study.
10799058|NCT02847637|BG003|Baseline|D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis)|Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799059|NCT02847637|BG004|Baseline|Total|Total of all reporting groups
10799060|NCT02847637|FG000|Participant Flow|C: No Prophylaxis|Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis.
10799061|NCT02847637|FG001|Participant Flow|A: Emicizumab 1.5 mg/kg/Week|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799062|NCT02847637|FG002|Participant Flow|B: Emicizumab 3 mg/kg/2 Weeks|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study.
11196518|NCT02164981|EG000|Reported Event|Drug - Drug|"Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
11196519|NCT02164981|EG001|Reported Event|Placebo - Drug|"Phase 1 - intravenous dextrose Phase 2 - intravenous sodium nitroprusside~sodium nitroprusside: intravenous"
10799063|NCT02847637|FG003|Participant Flow|D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis)|Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799064|NCT02847637|OG000|Outcome|C: No Prophylaxis|Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis.
10799065|NCT02847637|OG001|Outcome|A: Emicizumab 1.5 mg/kg/Week|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799066|NCT02847637|OG002|Outcome|B: Emicizumab 3 mg/kg/2 Weeks|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study.
11196520|NCT02164981|EG002|Reported Event|Placebo - Placebo|"Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose~Placebo: Placebo"
11196521|NCT02165072|BG000|Baseline|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
11196522|NCT02165072|FG000|Participant Flow|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
10799067|NCT02847637|OG003|Outcome|D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis)|Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799068|NCT02847637|OG000|Outcome|Dnisp: Pre-Study FVIII Prophylaxis in NIS BH29768|This arm includes historical data from participants in the non-interventional study (NIS) BH29768 who had received FVIII prophylaxis and were followed for a minimum of 24 weeks on the NIS prior to enrollment in Arm D of this study.
10799069|NCT02847637|OG001|Outcome|Dnisp: Emicizumab Prophylaxis (Pre-Study FVIII Prophylaxis)|This arm includes data from the same participants who had received FVIII prophylaxis in NIS BH29768 prior to study entry and then enrolled in Arm D of this study to receive emicizumab prophylaxis at a dose of 3 mg/kg/week subcutaneously (SC) for 4 weeks, followed by emicizumab 1.5 mg/kg/week SC until the end of study. The data reported was collected only during emicizumab prophylaxis treatment.
10799070|NCT02847637|OG000|Outcome|A+Bnise: Pre-Study Episodic FVIII in NIS BH29768|This arm includes historical data from participants in the non-interventional study (NIS) BH29768 who had received episodic FVIII treatment and were followed for a minimum of 24 weeks on the NIS prior to randomization to Arms A or B of this study. A pooled analysis, as opposed to two separate analyses, was performed due to the small number of NIS episodic patients (NISE) randomized to either Arm A or B.
10799071|NCT02847637|OG001|Outcome|A+Bnise: Emicizumab Prophylaxis (Pre-study Episodic FVIII)|This arm includes data from the same participants who had received episodic FVIII treatment in NIS BH29768 prior to study entry and then were randomized to Arms A or B of this study to receive emicizumab prophylaxis at a dose of 3 mg/kg/week subcutaneously (SC) for 4 weeks, followed by either emicizumab 1.5 mg/kg/week SC (Arm A) or emicizumab 3 mg/kg/2 weeks SC (Arm B) until the end of study. A pooled analysis, as opposed to two separate analyses, was performed due to the small number of NIS episodic patients (NISE) randomized to either Arm A or B. The data reported was collected only during emicizumab prophylaxis treatment.
10799072|NCT02847637|OG003|Outcome|Cemi: Emicizumab 3 mg/kg/2 Weeks (Switch From No Prophylaxis)|This arm includes all participants from Arm C who switched to emicizumab prophylaxis after completing at least 24 weeks on No Prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 3 mg/kg/2 weeks SC up to the end of study. The data reported was collected only during emicizumab prophylaxis treatment.
10799073|NCT02847637|OG004|Outcome|D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis)|Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799074|NCT02847637|OG000|Outcome|A: Emicizumab 1.5 mg/kg/Week|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799075|NCT02847637|OG001|Outcome|B: Emicizumab 3 mg/kg/2 Weeks|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study.
11196523|NCT02165072|OG000|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
11196524|NCT02165072|EG000|Reported Event|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
11196525|NCT02165111|BG000|Baseline|Onabotulinumtoxin A|"One hand of each patient was be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
11196526|NCT02165111|BG001|Baseline|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
11196527|NCT02165111|BG002|Baseline|Total|Total of all reporting groups
11196528|NCT02165111|FG000|Participant Flow|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand."
11196529|NCT02165111|FG001|Participant Flow|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each)."
11202333|NCT02207231|EG004|Reported Event|Guselkumab 100 mg (ACP)|Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
11196530|NCT02165111|OG000|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
11196531|NCT02165111|OG001|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
11196532|NCT02165111|OG000|Outcome|Onabotulinumtoxin A|"One hand of each patient were randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
11196533|NCT02165111|OG001|Outcome|Placebo|"One hand of each patient were randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
11196534|NCT02165111|EG000|Reported Event|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
11196535|NCT02165111|EG001|Reported Event|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
10799076|NCT02847637|OG002|Outcome|Cemi: Emicizumab 3 mg/kg/2 Weeks (Switch From No Prophylaxis)|This arm includes all participants from Arm C who switched to emicizumab prophylaxis after completing at least 24 weeks on No Prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 3 mg/kg/2 weeks SC up to the end of study. The data reported was collected only during emicizumab prophylaxis treatment.
11196536|NCT02165124|BG000|Baseline|Intervention/Bariatric Embolization|Artificial Embolization Device: Embosphere Microspheres
11196537|NCT02165124|FG000|Participant Flow|Intervention/Bariatric Embolization|Artificial Embolization Device: Embosphere Microspheres
11196538|NCT02165124|OG000|Outcome|Intervention/Bariatric Embolization|Artificial Embolization Device: Embosphere Microspheres
11196539|NCT02165124|EG000|Reported Event|Intervention/Bariatric Embolization|Artificial Embolization Device: Embosphere Microspheres
11196540|NCT02165202|BG000|Baseline|Rilpivirine|"Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."
11196541|NCT02165202|BG001|Baseline|Placebo|"Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit."
11196542|NCT02165202|BG002|Baseline|Total|Total of all reporting groups
11202334|NCT02207231|EG005|Reported Event|Adalimumab (ACP)|Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
11202335|NCT02207231|EG006|Reported Event|Adalimumab Then Guselkumab 100 mg (After ACP)|Participants initially randomized to adalimumab entered a washout period after their final dose at Week 47 and crossed over to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252. This arm reports safety data for participants that crossed over to guselkumab from adalimumab.
10799077|NCT02847637|EG000|Reported Event|C: No Prophylaxis|Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis.
10799078|NCT02847637|EG001|Reported Event|A: Emicizumab 1.5 mg/kg/Week|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799079|NCT02847637|EG002|Reported Event|B: Emicizumab 3 mg/kg/2 Weeks|Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study.
10799080|NCT02847637|EG003|Reported Event|Cemi: Emicizumab 3 mg/kg/2 Weeks (Switch From No Prophylaxis)|This arm includes all participants from Arm C who switched to emicizumab prophylaxis after completing at least 24 weeks on No Prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 3 mg/kg/2 weeks SC up to the end of study. The data reported was collected only during emicizumab prophylaxis treatment.
10799081|NCT02847637|EG004|Reported Event|D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis)|Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study.
10799082|NCT02837042|BG000|Baseline|Pembrolizumab 200 mg|"Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.~Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks."
10799083|NCT02837042|FG000|Participant Flow|Pembrolizumab 200 mg|"Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.~Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks."
10799084|NCT02837042|OG000|Outcome|Pembrolizumab 200 mg|"Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.~Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks."
10799085|NCT02837042|EG000|Reported Event|Pembrolizumab 200 mg|"Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.~Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks."
10799086|NCT02770391|BG000|Baseline|Apalutamide + Leuprolide Acetate|"All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to Apalutamide 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. Apalutamide may be continued up to and including the day before~Leuprolide acetate: Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3~Apalutamide: Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.~Radical prostatectomy"
10799087|NCT02770391|FG000|Participant Flow|Apalutamide + Leuprolide Acetate|"All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to Apalutamide 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. Apalutamide may be continued up to and including the day before~Leuprolide acetate: Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3~Apalutamide: Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.~Radical prostatectomy"
10799088|NCT02770391|OG000|Outcome|Apalutamide + Leuprolide Acetate|"All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to Apalutamide 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. Apalutamide may be continued up to and including the day before~Leuprolide acetate: Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3~Apalutamide: Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.~Radical prostatectomy"
10799089|NCT02770391|EG000|Reported Event|Apalutamide + Leuprolide Acetate|"All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to Apalutamide 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. Apalutamide may be continued up to and including the day before~Leuprolide acetate: Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3~Apalutamide: Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.~Radical prostatectomy"
10799090|NCT02650986|BG000|Baseline|Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^7"
10803443|NCT04109222|FG001|Participant Flow|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years|Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10799091|NCT02650986|BG001|Baseline|Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^8"
10799092|NCT02650986|BG002|Baseline|Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799093|NCT02650986|BG003|Baseline|Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Decitabine: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799094|NCT02650986|BG004|Baseline|Total|Total of all reporting groups
10799095|NCT02650986|FG000|Participant Flow|Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^7"
10799096|NCT02650986|FG001|Participant Flow|Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^8"
10799097|NCT02650986|FG002|Participant Flow|Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799098|NCT02650986|FG003|Participant Flow|Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Decitabine: Given IV at 20 mg/m^2 x 3 days~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799099|NCT02650986|OG000|Outcome|Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV at 1 x 10^7~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV"
10799100|NCT02650986|OG001|Outcome|Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV at 1 x 10^8~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV"
10799101|NCT02650986|OG002|Outcome|Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV at 1 x 10^9~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV"
11337879|NCT03595618|EG002|Reported Event|GLPG1972 300 mg|Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
11384414|NCT04466384|OG000|Outcome|Propofol|"Subjects will be sequentially assigned to start with propofol or propofol with remifentanil. Propofol will be started at a concentration of 0.5 µg/ml followed by incremental increases in the target effect-site concentrations of 1.5, 2, 2.5, 3, 4, 6, and 8 µg/ml until a MOAA/S score less than 2 is reached.~BIS: Subjects will be sequentially assigned to the propofol or propofol and remifentanil group. The purpose is to capture the BIS value in association with these anesthetics."
11384415|NCT04466384|OG001|Outcome|Propofol With Remifentanil|"Subjects will be sequentially assigned to start with propofol or propofol with remifentanil. Approximately 2 minutes before starting propofol, to attain an effect-site targeted concentration of remifentanil of 4 ng/ml, remifentanil will be given by a continuous infusion. Within approximately 7 minutes, the infusion rate of Remifentanil may be adjusted to maintain the effect-site concentration of remifentanil of 4 ng/ml throughout the study.~BIS: Subjects will be sequentially assigned to the propofol or propofol and remifentanil group. The purpose is to capture the BIS value in association with these anesthetics."
11384416|NCT04466384|EG000|Reported Event|Propofol First (First Phase)|Participants first received two regimens of Propofol (first phase). After a 1-week washout period, then received two regimens of Propofol with 4 ng/ml Remifentanil (cross over phase).
11384417|NCT04466384|EG001|Reported Event|First Propofol With Remifentanil (First Phase)|Participants first received two regimens of Propofol with 4 ng/ml Remifentanil (first phase). After a 1-week washout period, then received two regimens of Propofol (cross over phase).
11384418|NCT04466384|EG002|Reported Event|Propofol First (Cross Over Phase)|Participants first received two regimens of Propofol (first phase). After a 1-week washout period, then received two regimens of Propofol with 4 ng/ml Remifentanil (cross over phase).
11384419|NCT04466384|EG003|Reported Event|First Propofol With Remifentanil (Cross Over Phase)|Participants first received two regimens of Propofol with 4 ng/ml Remifentanil (first phase). After a 1-week washout period, then received two regimens of Propofol (cross over phase).
11384420|NCT04411953|BG000|Baseline|Sequence AB|"Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet~Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384421|NCT04411953|BG001|Baseline|Sequence BA|"Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet~Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384422|NCT04411953|BG002|Baseline|Total|Total of all reporting groups
11384423|NCT04411953|FG000|Participant Flow|Reference Product (Treatment A), Then Test Product (Treatment B)|"Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, United States Pharmacopeia (USP) (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with Investigational Medicinal Product (IMP) and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet~Then~Treatment B:"
10803444|NCT04109222|FG002|Participant Flow|Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years|Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
11384424|NCT04411953|FG001|Participant Flow|Test Product (Treatment B), Then Reference Product (Treatment A)|"Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet~Then~Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP."
11384425|NCT04411953|OG000|Outcome|Reference Product (Treatment A)|"Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384426|NCT04411953|OG001|Outcome|Test Product (Treatment B)|"Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11196543|NCT02165202|FG000|Participant Flow|Rilpivirine|"Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."
11202336|NCT02207231|EG007|Reported Event|Guselkumab Combined|All participants who crossed over to receive guselkumab (GUS) 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab. Participants that discontinued treatment prematurely were followed up for safety and hence were included in the safety data. Therefore, combined safety results are reported for this arm. This arm reports safety data for guselkumab.
11337880|NCT03595618|EG003|Reported Event|Placebo|Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
11337881|NCT03595904|BG000|Baseline|E-Motivate Group|Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
11337882|NCT03595904|BG001|Baseline|Usual Care Group|Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions).
11337883|NCT03595904|BG002|Baseline|Total|Total of all reporting groups
11337884|NCT03595904|FG000|Participant Flow|E-Motivate Group|Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
11337885|NCT03595904|FG001|Participant Flow|Usual Care Group|Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions).
11337886|NCT03595904|OG000|Outcome|E-Motivate Group|Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
11337887|NCT03595904|OG001|Outcome|Usual Care Group|Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions).
11337888|NCT03595904|EG000|Reported Event|E-Motivate Group|Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
11337889|NCT03595904|EG001|Reported Event|Usual Care Group|Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions).
11337890|NCT03596151|BG000|Baseline|Click Device|The study population was comprised of female participants >=14 years of age who visited any of the participating clinics for any reason, who performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
11337891|NCT03596151|FG000|Participant Flow|Click Device|"The study population was comprised of female participants >=14 years of age who visited any of the participating clinics for any reason, who may have been symptomatic or asymptomatic for STIs at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics.~Participants who met the inclusion/exclusion criteria were offered enrollment into the study. Participants who enrolled in the study provided clinical and demographic information, performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods. Participants completed the study in a single visit."
11337892|NCT03596151|OG000|Outcome|Click Device|The study population was comprised female participants >=14 years of age who visited any of the participating clinics for any reason, who performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
11337893|NCT03596151|EG000|Reported Event|Click Device|The study population was comprised female participants >=14 years of age who visited any of the participating clinics for any reason, who performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
10799102|NCT02650986|OG003|Outcome|Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV at 1 x 10^9~Decitabine: Given IV at 20 mg/m^2 x 3 days~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis"
10799103|NCT02650986|EG000|Reported Event|Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^7"
10799104|NCT02650986|EG001|Reported Event|Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^8"
10799105|NCT02650986|EG002|Reported Event|Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799106|NCT02650986|EG003|Reported Event|Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)|"Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.~Cyclophosphamide: Given IV~Decitabine: Given IV at 20 mg/m^2 x 3 days~Laboratory Biomarker Analysis: Correlative studies~Leukapheresis: Undergo leukapheresis~TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV at 1 x 10^9"
10799107|NCT02648724|BG000|Baseline|Part 1: Dose-Escalation, 6 mg/kg|"Sym015 was tested in four dose titration cohorts. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799108|NCT02648724|BG001|Baseline|Part 1: Dose-Escalation, 12 mg/kg|"Sym015 was tested in four dose titration cohorts. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799109|NCT02648724|BG002|Baseline|Part 1: Dose-Escalation 18 mg/kg|"Sym015 was tested in four dose titration cohorts. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799110|NCT02648724|BG003|Baseline|Part 1: Dose-Escalation 24 mg/kg|"Sym015 was tested in four dose titration cohorts. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799111|NCT02648724|BG004|Baseline|Part 2: Dose-Expansion, Basket Cohort|"Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799112|NCT02648724|BG005|Baseline|Part 2: Dose-Expansion, NSCLC MET-Amplified Cohort|"Patients with advanced NSCLC with MET-amplification received Sym015 at the RP2D. Patients may have received prior therapy with METtargeting and/or EGFR-targeting agents.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
11196544|NCT02165202|FG001|Participant Flow|Placebo|"Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit."
11202337|NCT02207244|BG000|Baseline|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
11337894|NCT03596177|BG000|Baseline|Placebo|Participants received subcutaneous (SC) injection of placebo for 16 days in the single-blind treatment period, and then SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period.
10799113|NCT02648724|BG006|Baseline|Part 2: Dose-Expansion, NSCLC METex14del Cohort|"Patients with advanced NSCLC with METex14del received Sym015 at the RP2D. Tumors need not be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799114|NCT02648724|BG007|Baseline|Total|Total of all reporting groups
10799115|NCT02648724|FG000|Participant Flow|Part 1: Dose-Escalation; Period 1: 6 mg/kg|"Patients received 6 mg/kg Symp015.~Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799116|NCT02648724|FG001|Participant Flow|Part 1: Dose-Escalation; Period 2: 12mg/kg|"Patients received 12 mg/kg Symp015.~Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799117|NCT02648724|FG002|Participant Flow|Part 1: Dose-Escalation; Period 3:18mg/kg|"Patients received 18 mg/kg Symp015.~Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799118|NCT02648724|FG003|Participant Flow|Part 1: Dose-Escalation; Period 4: 24 mg/kg|"Patients received 24 mg/kg Symp015-.~Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799119|NCT02648724|FG004|Participant Flow|Part 2: Dose-Expansion, Basket Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~Basket Cohort:~Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799120|NCT02648724|FG005|Participant Flow|Part 2: Dose-Expansion, NSCLC MET-Amplified Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~NSCLC MET-Amplified Cohort:~Patients with advanced NSCLC with MET-amplification were to receive Sym015 at the RP2D. Patients may have received prior therapy with METtargeting and/or EGFR-targeting agents.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799121|NCT02648724|FG006|Participant Flow|Part 2: Dose-Expansion, NSCLC METEx14Del Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~NSCLC METex14del Cohort:~Patients with advanced NSCLC with METex14del were to receive Sym015 at the RP2D. Tumors need not be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents. mutation.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799122|NCT02648724|OG000|Outcome|Part 1: Dose-Escalation; Period 1, 6 mg/kg|"Patients received 6 mg/kg Sym015.~Sym015 was tested in four dose titration cohorts. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799123|NCT02648724|OG001|Outcome|Part 1: Dose-Escalation; Period 2: 12mg/kg|"Patients received 12 mg/kg Symp015. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET"
10799124|NCT02648724|OG002|Outcome|Part 1: Dose-Escalation; Period 3:18mg/kg|"Patients received 18 mg/kg Symp015. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799125|NCT02648724|OG003|Outcome|Part 1: Dose-Escalation; Period 4: 24 mg/kg|"Patients received 24 mg/kg Symp015-. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799126|NCT02648724|OG000|Outcome|Part 2: Basket Cohort|"Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799127|NCT02648724|OG001|Outcome|Part 2: Patients in NSCLC MET-Amplified Cohort|"Patients had MET-amplified advanced NSCLC without available therapeutic options. Patients could have received prior therapy with MET-targeting and/or epidermal growth factor receptor (EGFR)-targeting agents.~NSCL = non-small cell lung cancer. MET = MET proto-oncogene tyrosine kinase, hepatocyte growth factor receptor."
11384427|NCT04411953|EG000|Reported Event|Reference Product (Treatment A)|"Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384428|NCT04411953|EG001|Reported Event|Test Product (Treatment B)|"Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384429|NCT04411940|BG000|Baseline|Sequence AB|"Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet~Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384430|NCT04411940|BG001|Baseline|Sequence BA|"Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet~Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384431|NCT04411940|BG002|Baseline|Total|Total of all reporting groups
11384432|NCT04411940|FG000|Participant Flow|Reference Product (Treatment A), Then Test Product (Treatment B)|"Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, United States Pharmacopeia (USP) (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with Investigational Medicinal Product (IMP) and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet~Then~Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384433|NCT04411940|FG001|Participant Flow|Test Product (Treatment B), Then Reference Product (Treatment A)|"Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet~Then~Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384434|NCT04411940|OG000|Outcome|Reference Product (Treatment A)|"Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384435|NCT04411940|OG001|Outcome|Test Product (Treatment B)|"Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384436|NCT04411940|EG000|Reported Event|Reference Product (Treatment A)|"Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet"
11384437|NCT04411940|EG001|Reported Event|Test Product (Treatment B)|"Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.~Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet"
11384438|NCT04068792|BG000|Baseline|Placebo|As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 [greater than or equal to {>=} 28 days and less than {<} 3 months], for Age Group 2 [>=3 and <6 months], and for Age Group 3 [>=6 months]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
10799128|NCT02648724|OG002|Outcome|Part 2: Patients in NSCLC METEx14Del Cohort|Patients had advanced NSCLC with METEx14Del, and without available therapeutic options. Tumors did not need to be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents. NSCLC = non-small cell lung cancer. METEx14Del = MET exon 14 skipping alteration. EGFR = epidermal growth factor receptor.
10799129|NCT02648724|OG000|Outcome|Part 1: Dose-Escalation (4 Arms Combined)|"Sym015 was tested in four dose titration cohorts (6, 12, 18 and 24 mg/kg) with 3 patients per dose level. A substitute or an additional dose level could potentially be evaluated.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799130|NCT02648724|OG000|Outcome|6 mg/kg|Cohort of subjects receiving a dose of 6 mg/kg of Sym015 administered by intravenous infusion Q2W. Q2W = every second week.
10799131|NCT02648724|OG001|Outcome|12 mg/kg|Cohort of subjects receiving a dose of 12 mg/kg of Sym015 administered by intravenous infusion Q2W. Q2W = every second week.
10799132|NCT02648724|OG002|Outcome|18 mg/kg|Cohort of subjects receiving a dose of 18 mg/kg of Sym015 administered by intravenous infusion Q2W. Q2W = every second week.
10799133|NCT02648724|OG003|Outcome|24 mg/kg|Cohort of subjects receiving a dose of 24 mg/kg of Sym015 administered by intravenous infusion Q2W. Q2W = every second week.
10799134|NCT02648724|OG000|Outcome|Part 2 (Dose Expansion): Basket Cohort|"Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.~Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI)."
10799135|NCT02648724|OG001|Outcome|Part 2 (Dose Expansion): Patients in NSCLC MET-Amplified Cohort|"Patients had MET-amplified advanced NSCLC without available therapeutic options. Patients could have received prior therapy with MET-targeting and/or epidermal growth factor receptor (EGFR)-targeting agents.~Sym015 was administered at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.~NSCL = non-small cell lung cancer. MET = MET proto-oncogene tyrosine kinase, hepatocyte growth factor receptor."
10799136|NCT02648724|OG002|Outcome|Part 2 (Dose Expansion): Patients in NSCLC METEx14Del Cohort|"Patients had advanced NSCLC with METEx14Del, and without available therapeutic options. Tumors did not need to be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents.~Sym015 was administered at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.~NSCLC = non-small cell lung cancer. METEx14Del = MET exon 14 skipping alteration. EGFR = epidermal growth factor receptor."
10799137|NCT02648724|OG000|Outcome|Part 2 (Dose-Expansion): Basket Cohort|Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).
11202338|NCT02207244|BG001|Baseline|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
10799138|NCT02648724|OG001|Outcome|Part 2 (Dose-Expansion): Patients in NSCLC MET-Amplified Cohort|"Patients had MET-amplified advanced NSCLC without available therapeutic options. Patients could have received prior therapy with MET-targeting and/or epidermal growth factor receptor (EGFR)-targeting agents.~Sym015 was administered at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.~NSCL = non-small cell lung cancer. MET = MET proto-oncogene tyrosine kinase, hepatocyte growth factor receptor."
10799139|NCT02648724|OG002|Outcome|Part 2 (Dose-Expansion): Patients in NSCLC METEx14Del Cohort|"Patients had advanced NSCLC with METEx14Del, and without available therapeutic options. Tumors did not need to be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents.~Sym015 was administered at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.~NSCLC = non-small cell lung cancer. METEx14Del = MET exon 14 skipping alteration. EGFR = epidermal growth factor receptor."
10799140|NCT02648724|OG000|Outcome|Part 2 (Dose-Expansion): Basket Cohort|"Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose.. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799141|NCT02648724|OG000|Outcome|Part 2 (Dose-Expansion): Basket Cohort|Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).
10799142|NCT02648724|OG000|Outcome|Part 2 (Dose-Expansion): Basket Cohort|"Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose: 18 mg/kg loading dose followed by 12 mg/kg Q2W maintenance dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799143|NCT02648724|OG000|Outcome|Patients With Prior MET-targeting TKI Therapy (Basket Cohort)|Patients in Basket Cohort, with prior MET-targeting TKI therapy. MET = MET proto-oncogene tyrosine kinase, hepatocyte growth factor receptor. TKI = tyrosine kinase inhibitor.
10799144|NCT02648724|OG001|Outcome|Patients Without Prior MET-targeting TKI Therapy (Basket Cohort)|Patients in Basket Cohort, without prior MET-targeting TKI therapy. MET = MET proto-oncogene tyrosine kinase, hepatocyte growth factor receptor. TKI = tyrosine kinase inhibitor.
10799145|NCT02648724|EG000|Reported Event|Part 1: Dose-Escalation; Period 1: 6 mg/kg|"Patients received 6 mg/kg Symp015. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
11202339|NCT02207244|BG002|Baseline|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and thereafter through week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
11384439|NCT04068792|BG001|Baseline|JNJ-53718678|As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 [>= 28 days and < 3 months]: 5 milligrams/kilogram [mg/kg]; for Age Group 2 [>=3 and <6 months]: 6 mg/kg and for Age Group 3 [>=6 months]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
11384440|NCT04068792|BG002|Baseline|Total|Total of all reporting groups
11384441|NCT04068792|FG000|Participant Flow|Placebo|As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 [greater than or equal to {>=} 28 days and less than {<} 3 months], for Age Group 2 [>=3 and <6 months], and for Age Group 3 [>=6 months]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
11384442|NCT04068792|FG001|Participant Flow|JNJ-53718678|As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 [>= 28 days and < 3 months]: 5 milligrams/kilogram [mg/kg]; for Age Group 2 [>=3 and <6 months]: 6 mg/kg and for Age Group 3 [>=6 months]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
11384443|NCT04068792|OG000|Outcome|Placebo|As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 [greater than or equal to {>=} 28 days and less than {<} 3 months], for Age Group 2 [>=3 and <6 months], and for Age Group 3 [>=6 months]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
11384444|NCT04068792|OG001|Outcome|JNJ-53718678|As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 [>= 28 days and < 3 months]: 5 milligrams/kilogram [mg/kg]; for Age Group 2 [>=3 and <6 months]: 6 mg/kg and for Age Group 3 [>=6 months]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
11384445|NCT04068792|EG000|Reported Event|Placebo|As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 [greater than or equal to {>=} 28 days and less than {<} 3 months], for Age Group 2 [>=3 and <6 months], and for Age Group 3 [>=6 months]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
11384446|NCT04068792|EG001|Reported Event|JNJ-53718678|As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 [>= 28 days and < 3 months]: 5 milligrams/kilogram [mg/kg]; for Age Group 2 [>=3 and <6 months]: 6 mg/kg and for Age Group 3 [>=6 months]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
11202340|NCT02207244|BG003|Baseline|Total|Total of all reporting groups
10799146|NCT02648724|EG001|Reported Event|Part 1: Dose-Escalation; Period 2: 12mg/kg|"Patients received 12 mg/kg Symp015. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799147|NCT02648724|EG002|Reported Event|Part 1: Dose-Escalation; Period 3:18mg/kg|"Patients received 18 mg/kg Symp015. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799148|NCT02648724|EG003|Reported Event|Part 1: Dose-Escalation; Period 4: 24 mg/kg|"Patients received 24 mg/kg Symp015-. Sym015 was tested in four dose titration cohorts. Patients received increasing doses of 6, 12, 18 and 24 mg/kg every second week (Q2W). A substitute or an additional dose level could potentially be evaluated.~Dose-escalation followed a standard 3+3 design with escalation dependent upon the occurrence of dose level toxicity.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799149|NCT02648724|EG004|Reported Event|Part 2: Dose-Expansion, Basket Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~Basket Cohort:~Patients with KRAS proto-oncogene wild-type (KRAS WT) advanced solid tumor malignancies with MET-amplification received Sym015 at the recommended Phase 2 dose. Included in this group was a subset of patients who received prior therapy with a MET-targeting tyrosine kinase inhibitor (TKI).~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799150|NCT02648724|EG005|Reported Event|Part 2: Dose-Expansion, NSCLC MET-Amplified Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~NSCLC MET-Amplified Cohort:~Patients with advanced NSCLC with MET-amplification were to receive Sym015 at the RP2D. Patients may have received prior therapy with METtargeting and/or EGFR-targeting agents.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799151|NCT02648724|EG006|Reported Event|Part 2: Dose-Expansion, NSCLC METEx14Del Cohort|"During Part 2, three Cohorts received Sym015 at the recommended phase 2 dose on a every second week dosing schedule:~NSCLC METex14del Cohort:~Patients with advanced NSCLC with METex14del were to receive Sym015 at the RP2D. Tumors need not be MET-amplified, and patients may have received prior therapy with MET-targeting and/or EGFR-targeting agents. mutation.~Sym015: Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET."
10799152|NCT02614794|BG000|Baseline|Tuc+Cap+Tra|Tucatinib in combination with capecitabine & trastuzumab
10799153|NCT02614794|BG001|Baseline|Pbo+Cap+Tra|Placebo in combination with capecitabine & trastuzumab
10799154|NCT02614794|BG002|Baseline|Total|Total of all reporting groups
10799155|NCT02614794|FG000|Participant Flow|Tuc+Cap+Tra|Tucatinib in combination with capecitabine & trastuzumab
10799156|NCT02614794|FG001|Participant Flow|Pbo+Cap+Tra|Placebo in combination with capecitabine & trastuzumab
10799157|NCT02614794|OG000|Outcome|Tuc+Cap+Tra|Tucatinib in combination with capecitabine & trastuzumab
10799158|NCT02614794|OG001|Outcome|Pbo+Cap+Tra|Placebo in combination with capecitabine & trastuzumab
10799159|NCT02614794|EG000|Reported Event|Tuc+Cap+Tra|Tucatinib in combination with capecitabine & trastuzumab
10799160|NCT02614794|EG001|Reported Event|Pbo+Cap+Tra|Placebo in combination with capecitabine & trastuzumab
10799161|NCT02554474|BG000|Baseline|Immediate Group|Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
10799162|NCT02554474|BG001|Baseline|Delay Group|Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
10799163|NCT02554474|BG002|Baseline|Total|Total of all reporting groups
10799164|NCT02554474|FG000|Participant Flow|Immediate Group|"Education, Fitbit/FitViz, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls.~Education, Fitbit/FitViz, physiotherapist counselling.: Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately."
10799165|NCT02554474|FG001|Participant Flow|Delay Group|"Same intervention with a 2 month delay: The full intervention will be initiated in Month 3 and 4 with a brief education session, use of a Fitbit paired with the FitViz app, and counseling by a PT. In Month 5-6, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed.~Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay."
10803445|NCT04109222|OG000|Outcome|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10799166|NCT02554474|OG000|Outcome|Immediate Group|Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
10799167|NCT02554474|OG001|Outcome|Delay Group|Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
10799168|NCT02554474|EG000|Reported Event|Immediate Group|Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.
10799169|NCT02554474|EG001|Reported Event|Delay Group|Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.
10799170|NCT02554318|BG000|Baseline|Intervention|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~and 166.5 grams cooked fermented soybean (tempeh) daily for two months~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol~Fermented soybean"
10799171|NCT02554318|BG001|Baseline|Control|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol"
10799172|NCT02554318|BG002|Baseline|Total|Total of all reporting groups
10799173|NCT02554318|FG000|Participant Flow|Intervention|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~and 166.5 grams cooked fermented soybean (tempeh) daily for two months~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol~Fermented soybean"
10799174|NCT02554318|FG001|Participant Flow|Control|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol"
10799175|NCT02554318|OG000|Outcome|Intervention|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~and 166.5 grams cooked fermented soybean (tempeh) daily for two months~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol~Fermented soybean"
10799176|NCT02554318|OG001|Outcome|Control|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol"
10799177|NCT02554318|EG000|Reported Event|Intervention|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~and 166.5 grams cooked fermented soybean (tempeh) daily for two months~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol~Fermented soybean"
10799178|NCT02554318|EG001|Reported Event|Control|"TB standard therapy with fixed dose combination :~once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,~Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets~Rifampicin~Isoniazid~Pyrazinamide~Ethambutol"
10803446|NCT04109222|OG001|Outcome|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years|Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
11384447|NCT03960541|BG000|Baseline|CD24Fc 240 mg|Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28.
11384448|NCT03960541|BG001|Baseline|Placebo|Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28.
11384449|NCT03960541|BG002|Baseline|Total|Total of all reporting groups
11384450|NCT03960541|FG000|Participant Flow|CD24Fc 240 mg|Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28.
11384451|NCT03960541|FG001|Participant Flow|Placebo|Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28.
11384452|NCT03960541|OG000|Outcome|CD24Fc 240 mg|Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28.
11384453|NCT03960541|OG001|Outcome|Placebo|Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28.
11384454|NCT03960541|EG000|Reported Event|CD24Fc 240 mg|Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28.
11384455|NCT03960541|EG001|Reported Event|Placebo|Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28.
11384456|NCT03951077|BG000|Baseline|Placebo|Placebo taken orally BID
11384457|NCT03951077|BG001|Baseline|Elagolix 25 mg BID|Elagolix 25 mg taken orally BID plus placebo
11384458|NCT03951077|BG002|Baseline|Elagolix 50 mg QD|Elagolix 50 mg taken orally QD plus placebo
11384459|NCT03951077|BG003|Baseline|Elagolix 75 mg BID|Elagolix 75 mg taken orally BID plus placebo
11384460|NCT03951077|BG004|Baseline|Elagolix 150 mg QD|Elagolix 150 mg taken orally QD plus placebo
11384461|NCT03951077|BG005|Baseline|Elagolix 300 mg QD|Elagolix 300 mg taken orally QD plus placebo
11384462|NCT03951077|BG006|Baseline|Total|Total of all reporting groups
11384463|NCT03951077|FG000|Participant Flow|Placebo|Placebo taken orally BID
11384464|NCT03951077|FG001|Participant Flow|Elagolix 25 mg BID|Elagolix 25 mg taken orally BID plus placebo
11384465|NCT03951077|FG002|Participant Flow|Elagolix 50 mg QD|Elagolix 50 mg taken orally QD plus placebo
11384466|NCT03951077|FG003|Participant Flow|Elagolix 75 mg BID|Elagolix 75 mg taken orally BID plus placebo
11384467|NCT03951077|FG004|Participant Flow|Elagolix 150 mg QD|Elagolix 150 mg taken orally QD plus placebo
11384468|NCT03951077|FG005|Participant Flow|Elagolix 300 mg QD|Elagolix 300 mg taken orally QD plus placebo
11384469|NCT03951077|OG000|Outcome|Placebo|Placebo taken orally BID
11384470|NCT03951077|OG001|Outcome|Elagolix 25 mg BID|Elagolix 25 mg taken orally BID plus placebo
11384471|NCT03951077|OG002|Outcome|Elagolix 50 mg QD|Elagolix 50 mg taken orally QD plus placebo
11384472|NCT03951077|OG003|Outcome|Elagolix 75 mg BID|Elagolix 75 mg taken orally BID plus placebo
11384473|NCT03951077|OG004|Outcome|Elagolix 150 mg QD|Elagolix 150 mg taken orally QD plus placebo
11384474|NCT03951077|OG005|Outcome|Elagolix 300 mg QD|Elagolix 300 mg taken orally QD plus placebo
11384475|NCT03951077|EG000|Reported Event|Placebo|Placebo taken orally BID
11384476|NCT03951077|EG001|Reported Event|Elagolix 25 mg BID|Elagolix 25 mg taken orally BID plus placebo
10803447|NCT04109222|OG000|Outcome|Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years|Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
11384477|NCT03951077|EG002|Reported Event|Elagolix 50 mg QD|Elagolix 50 mg taken orally QD plus placebo
11384478|NCT03951077|EG003|Reported Event|Elagolix 75 mg BID|Elagolix 75 mg taken orally BID plus placebo
11384479|NCT03951077|EG004|Reported Event|Elagolix 150 mg QD|Elagolix 150 mg taken orally QD plus placebo
11384480|NCT03951077|EG005|Reported Event|Elagolix 300 mg QD|Elagolix 300 mg taken orally QD plus placebo
11384481|NCT03873246|BG000|Baseline|OC-01 0.1%, 0.6 mg/ml|"OC-01 (varenicline) nasal spray, 0.6 mg/mL~OC-01 0.1% 0.6 mg/ml: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)"
11384482|NCT03873246|BG001|Baseline|OC-01 0.2%, 1.2 mg/ml|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml): OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)"
11384483|NCT03873246|BG002|Baseline|Placebo|"vehicle control~placebo comparator: vehicle control"
11384484|NCT03873246|BG003|Baseline|Total|Total of all reporting groups
11384485|NCT03873246|FG000|Participant Flow|OC-01 0.1%, 0.6 mg/ml|"OC-01 (varenicline) nasal spray, 0.6 mg/mL~OC-01 0.1% 0.6 mg/ml: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)"
11384486|NCT03873246|FG001|Participant Flow|OC-01 0.2%, 1.2 mg/ml|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml): OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)"
11384487|NCT03873246|FG002|Participant Flow|Placebo|"vehicle control~placebo comparator: vehicle control"
11384488|NCT03873246|OG000|Outcome|OC-01 0.1%, 0.6 mg/ml|"OC-01 (varenicline) nasal spray, 0.6 mg/mL~OC-01 0.1% 0.6 mg/ml: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)"
11384489|NCT03873246|OG001|Outcome|OC-01 0.2%. 1.2 mg/ml|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml): OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)"
11384490|NCT03873246|OG002|Outcome|Placebo|"vehicle control~placebo comparator: vehicle control"
11384491|NCT03873246|OG001|Outcome|OC-01 0.2%, 1.2 mg/ml|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml): OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)"
11384492|NCT03873246|EG000|Reported Event|OC-01 0.1%, 0.6 mg/ml|"OC-01 (varenicline) nasal spray, 0.6 mg/mL~OC-01 0.1% 0.6 mg/ml: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)"
11384493|NCT03873246|EG001|Reported Event|OC-01 0.2%, 1.2 mg/ml|"OC-01 (varenicline) nasal spray, 1.2 mg/mL~OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml): OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)"
11384494|NCT03873246|EG002|Reported Event|Placebo|"vehicle control~placebo comparator: vehicle control"
11384495|NCT03807349|BG000|Baseline|N-Force Screws|"N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.~N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)"
11384496|NCT03807349|FG000|Participant Flow|N-Force Screws|"N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.~N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)"
11384497|NCT03807349|OG000|Outcome|N-Force Screws|"N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.~N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)"
11384498|NCT03807349|EG000|Reported Event|N-Force Screws|"N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.~N-Force Screws Augmented with N-Force Blue: N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)"
11384499|NCT03769649|BG000|Baseline|Treatment Arm|"Subjects receive CelluTite treatment followed by Morpheus8 treatment~CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF"
11384500|NCT03769649|FG000|Participant Flow|Treatment Arm|"Subjects receive CelluTite treatment followed by Morpheus8 treatment~CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF"
11384501|NCT03769649|OG000|Outcome|Treatment Arm|"Subjects receive CelluTite treatment followed by Morpheus8 treatment~CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF"
11384502|NCT03769649|EG000|Reported Event|Treatment Arm|"Subjects receive CelluTite treatment followed by Morpheus8 treatment~CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF"
11384503|NCT03714880|BG000|Baseline|Mifepristone|"Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement~Mifepristone 200 MG: Ingestion of study medication"
11384504|NCT03714880|BG001|Baseline|Placebo|"Participants ingest placebo oral medication once 18-24 hours prior to dilator placement~Placebo Oral Tablet: Ingestion of placebo"
11384505|NCT03714880|BG002|Baseline|Total|Total of all reporting groups
11384506|NCT03714880|FG000|Participant Flow|Mifepristone|"Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement~Mifepristone 200 MG: Ingestion of study medication"
11384507|NCT03714880|FG001|Participant Flow|Placebo|"Participants ingest placebo oral medication once 18-24 hours prior to dilator placement~Placebo Oral Tablet: Ingestion of placebo"
11384508|NCT03714880|OG000|Outcome|Mifepristone|"Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement~Mifepristone 200 MG: Ingestion of study medication"
11384509|NCT03714880|OG001|Outcome|Placebo|"Participants ingest placebo oral medication once 18-24 hours prior to dilator placement~Placebo Oral Tablet: Ingestion of placebo"
11384510|NCT03714880|OG000|Outcome|Mifepristone|Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement
11384511|NCT03714880|OG001|Outcome|Placebo|Participants ingest placebo oral medication once 18-24 hours prior to dilator placement
11384512|NCT03714880|EG000|Reported Event|Mifepristone|"Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement~Mifepristone 200 MG: Ingestion of study medication"
11384513|NCT03714880|EG001|Reported Event|Placebo|"Participants ingest placebo oral medication once 18-24 hours prior to dilator placement~Placebo Oral Tablet: Ingestion of placebo"
11384514|NCT03645941|BG000|Baseline|Quitline/Treatment Referral|Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)
11384515|NCT03645941|BG001|Baseline|Facebook+Quitline/Treatment Referral|"Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months~Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement~Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)~Facebook Group: The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up."
11384516|NCT03645941|BG002|Baseline|Total|Total of all reporting groups
11384517|NCT03645941|FG000|Participant Flow|Quitline/Treatment Referral|Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)
10799194|NCT02508532|BG000|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD|"Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799195|NCT02508532|BG001|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD|"Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799196|NCT02508532|BG002|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD|"Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799197|NCT02508532|BG003|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD|"Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799198|NCT02508532|BG004|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD|"Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation. ."
10799199|NCT02508532|BG005|Baseline|Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD|"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799200|NCT02508532|BG006|Baseline|Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD|"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis.~Patients received avapritinib in continuous 28 day cycles until discontinuation.~Includes 13 patients from Part 1"
10799201|NCT02508532|BG007|Baseline|Total|Total of all reporting groups
10799202|NCT02508532|FG000|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD|"Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799203|NCT02508532|FG001|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD|"Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799204|NCT02508532|FG002|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD|"Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799205|NCT02508532|FG003|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD|"Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799206|NCT02508532|FG004|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD|"Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation. ."
10799207|NCT02508532|FG005|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD|"Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799208|NCT02508532|FG006|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD|"Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799209|NCT02508532|FG007|Participant Flow|Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD|"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799210|NCT02508532|FG008|Participant Flow|Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD|"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799211|NCT02508532|OG000|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD|"Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799212|NCT02508532|OG001|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD|"Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799213|NCT02508532|OG002|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD|"Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799214|NCT02508532|OG003|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD|"Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799215|NCT02508532|OG004|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD|"Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation. ."
10799216|NCT02508532|OG005|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD|"Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis."
10799217|NCT02508532|OG006|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD|"Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation.~Patients that received at least one dose of avapritinib were included in the Part 2 analysis."
10799218|NCT02508532|OG007|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD|"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799219|NCT02508532|OG005|Outcome|Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD|"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
11202341|NCT02207244|FG000|Participant Flow|Placebo (Week 0 - 16)|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
10799220|NCT02508532|OG006|Outcome|Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD|"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. 13 patients in this group were enrolled in Part 1~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799221|NCT02508532|OG000|Outcome|Patients With a PDGFRA D842V Mutation|Patients with a PDGFRA D842V Mutation, any line of treatment
10799222|NCT02508532|OG001|Outcome|2L Patients Without a PDGFRA D842V Mutation|Patients that do not have a PDGFRA D842V mutation and have received 1 prior line of therapy
10799223|NCT02508532|OG002|Outcome|3L Patients Without a PDGFRA D842V Mutation|Patients that do not have a PDGFRA D842V mutation and have had 2 or more prior lines of therapy
10799224|NCT02508532|OG000|Outcome|Part 1 Avapritinib (Formerly BLU-285) 300 mg QD|Part 1 and Part 2: Patients received a starting dose of 300 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
10799225|NCT02508532|OG001|Outcome|Part 1 Avapritinib (Formerly BLU-285) 400 mg QD|Part 1 and Part 2: Patients received a starting dose of 400 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
10799226|NCT02508532|OG000|Outcome|Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD|Part 1 and Part 2: Patients received a starting dose of 300 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
10799227|NCT02508532|OG001|Outcome|Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD|Part 1 and Part 2: Patients received a starting dose of 400 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
10799228|NCT02508532|OG000|Outcome|Patients With a PDGFRA D842V Mutation|Patients with a PDGFRA D842V mutation, any line of treatment
10799229|NCT02508532|OG000|Outcome|Patients With PDGFRA D842V Mutation|Patients with a PDGFRA D842V mutation, any line of treatment
10799230|NCT02508532|OG000|Outcome|Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD|"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799231|NCT02508532|EG000|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD|"Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799232|NCT02508532|EG001|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD|"Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799233|NCT02508532|EG002|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD|"Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799234|NCT02508532|EG003|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD|"Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799235|NCT02508532|EG004|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD|"Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799236|NCT02508532|EG005|Reported Event|Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD|"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799237|NCT02508532|EG006|Reported Event|Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD|"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis.~Patients received avapritinib in continuous 28 day cycles until discontinuation."
10799238|NCT02489318|BG000|Baseline|Placebo + Androgen Deprivation Therapy (ADT)|Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799239|NCT02489318|BG001|Baseline|Apalutamide + ADT|Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799240|NCT02489318|BG002|Baseline|Total|Total of all reporting groups
10799241|NCT02489318|FG000|Participant Flow|Placebo + Androgen Deprivation Therapy (ADT)|Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
11337895|NCT03596177|BG001|Baseline|MEDI0382|Participants received SC injection of placebo for 16 days in the single-blind treatment period, and then SC injection of MEDI0382 titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
11337896|NCT03596177|BG002|Baseline|Total|Total of all reporting groups
10799242|NCT02489318|FG001|Participant Flow|Apalutamide + ADT|Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799243|NCT02489318|OG000|Outcome|Placebo + Androgen Deprivation Therapy (ADT)|Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799244|NCT02489318|OG001|Outcome|Apalutamide + ADT|Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799245|NCT02489318|EG000|Reported Event|Placebo + Androgen Deprivation Therapy (ADT)|Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799246|NCT02489318|EG001|Reported Event|Placebo + ADT to Apalutamide + ADT|After interim analysis and unblinding, participants receiving placebo +ADT crossed over to receive 240 mg apalutamide orally qd along with ADT in open-label extension phase.
10799247|NCT02489318|EG002|Reported Event|Apalutamide + ADT|Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799248|NCT02421939|BG000|Baseline|Gilteritinib|Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.
10799249|NCT02421939|BG001|Baseline|Salvage Chemotherapy|Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.
10799250|NCT02421939|BG002|Baseline|Total|Total of all reporting groups
10799251|NCT02421939|FG000|Participant Flow|Gilteritinib|Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.
10799252|NCT02421939|FG001|Participant Flow|Salvage Chemotherapy|Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.
10799253|NCT02421939|OG000|Outcome|Gilteritinib|Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.
10799254|NCT02421939|OG001|Outcome|Salvage Chemotherapy|Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.
10799255|NCT02421939|EG000|Reported Event|Gilteritinib|Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.
10799256|NCT02421939|EG001|Reported Event|Salvage Chemotherapy|Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.
10799257|NCT02358031|BG000|Baseline|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months.
10799258|NCT02358031|BG001|Baseline|Pembrolizumab + Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months; plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799259|NCT02358031|BG002|Baseline|Cetuximab + Chemotherapy (Control)|Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799260|NCT02358031|BG003|Baseline|Total|Total of all reporting groups
10799261|NCT02358031|FG000|Participant Flow|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months.
10799262|NCT02358031|FG001|Participant Flow|Pembrolizumab + Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months; plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799263|NCT02358031|FG002|Participant Flow|Cetuximab + Chemotherapy (Control)|Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799264|NCT02358031|OG000|Outcome|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months.
10799265|NCT02358031|OG001|Outcome|Pembrolizumab + Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months; plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799266|NCT02358031|OG002|Outcome|Cetuximab + Chemotherapy (Control)|Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799267|NCT02358031|EG000|Reported Event|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months.
10799268|NCT02358031|EG001|Reported Event|Pembrolizumab + Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months; plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799269|NCT02358031|EG002|Reported Event|Cetuximab + Chemotherapy (Control)|Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
10799270|NCT02317705|BG000|Baseline|OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer|Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
10799271|NCT02317705|FG000|Participant Flow|OTL38 for Intra-operativeImaging of Folate Receptor-alpha Positive Ovarian Cancer|Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
10799272|NCT02317705|OG000|Outcome|Experimental|Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
10799273|NCT02317705|EG000|Reported Event|Patients Receiving OTL38|"All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.~OTL38~Near infrared camera imaging system: Near infrared camera imaging system~Laparotomy: primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery"
10799274|NCT02277444|BG000|Baseline|Golimumab|Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
10799275|NCT02277444|FG000|Participant Flow|Golimumab|Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
10799276|NCT02277444|OG000|Outcome|Golimumab|Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
10799277|NCT02277444|EG000|Reported Event|Golimumab|Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted.
10799278|NCT02272803|BG000|Baseline|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Lenalidomide~25 mg taken orally once daily, Days 1 - 21 of each cycle~Dexamethasone~Administered on Days 1, 8, 15, and 22 of each cycle:~On weeks when elotuzumab is administered:~28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND~8 mg IV (at least 45 minutes prior to elotuzumab administration)~On weeks when elotuzumab is NOT administered:~- 40 mg taken orally~Elotuzumab (BMS-901608)~Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22~Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15~Cycle 19 and beyond: 20 mg/kg IV, Day 1"
10799279|NCT02272803|BG001|Baseline|Arm B: Lenalidomide + Dexamethasone|"Lenalidomide~25 mg taken orally once a day, Days 1 - 21 of each cycle~Dexamethasone~40 mg taken orally, Days 1, 8, 15, and 22 of each cycle"
10799280|NCT02272803|BG002|Baseline|Total|Total of all reporting groups
10799281|NCT02272803|FG000|Participant Flow|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Lenalidomide~25 mg taken orally once daily, Days 1 - 21 of each cycle~Dexamethasone~Administered on Days 1, 8, 15, and 22 of each cycle:~On weeks when elotuzumab is administered:~28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND~8 mg IV (at least 45 minutes prior to elotuzumab administration)~On weeks when elotuzumab is NOT administered:~- 40 mg taken orally~Elotuzumab (BMS-901608)~Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22~Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15~Cycle 19 and beyond: 20 mg/kg IV, Day 1"
10799282|NCT02272803|FG001|Participant Flow|Arm B: Lenalidomide + Dexamethasone|"Lenalidomide~25 mg taken orally once a day, Days 1 - 21 of each cycle~Dexamethasone~40 mg taken orally, Days 1, 8, 15, and 22 of each cycle"
10799283|NCT02272803|OG000|Outcome|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Lenalidomide~25 mg taken orally once daily, Days 1 - 21 of each cycle~Dexamethasone~Administered on Days 1, 8, 15, and 22 of each cycle:~On weeks when elotuzumab is administered:~28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND~8 mg IV (at least 45 minutes prior to elotuzumab administration)~On weeks when elotuzumab is NOT administered:~- 40 mg taken orally~Elotuzumab (BMS-901608)~Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22~Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15~Cycle 19 and beyond: 20 mg/kg IV, Day 1"
10799284|NCT02272803|OG001|Outcome|Arm B: Lenalidomide + Dexamethasone|"Lenalidomide~25 mg taken orally once a day, Days 1 - 21 of each cycle~Dexamethasone~40 mg taken orally, Days 1, 8, 15, and 22 of each cycle"
10799285|NCT02272803|EG000|Reported Event|Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)|"Lenalidomide~25 mg taken orally once daily, Days 1 - 21 of each cycle~Dexamethasone~Administered on Days 1, 8, 15, and 22 of each cycle:~On weeks when elotuzumab is administered:~28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND~8 mg IV (at least 45 minutes prior to elotuzumab administration)~On weeks when elotuzumab is NOT administered:~- 40 mg taken orally~Elotuzumab (BMS-901608)~Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22~Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15~Cycle 19 and beyond: 20 mg/kg IV, Day 1"
10799286|NCT02272803|EG001|Reported Event|Arm B: Lenalidomide + Dexamethasone|"Lenalidomide~25 mg taken orally once a day, Days 1 - 21 of each cycle~Dexamethasone~40 mg taken orally, Days 1, 8, 15, and 22 of each cycle"
10799287|NCT02257736|BG000|Baseline|Placebo+ Abiraterone Acetate - Prednisolone|Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799288|NCT02257736|BG001|Baseline|Apalutamide + Abiraterone Acetate - Prednisolone|Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799289|NCT02257736|BG002|Baseline|Total|Total of all reporting groups
10799290|NCT02257736|FG000|Participant Flow|Placebo+ Abiraterone Acetate - Prednisolone|Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10803448|NCT04109222|EG000|Reported Event|Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months|Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
11384518|NCT03645941|FG001|Participant Flow|Facebook+Quitline/Treatment Referral|"Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months~Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement~Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)~Facebook Group: The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up."
11384519|NCT03645941|OG000|Outcome|Quitline/Treatment Referral|Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)
11384520|NCT03645941|OG001|Outcome|Facebook+Quitline/Treatment Referral|"Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months~Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement~Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)~Facebook Group: The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up."
11384521|NCT03645941|EG000|Reported Event|Quitline/Treatment Referral|Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)
11384522|NCT03645941|EG001|Reported Event|Facebook+Quitline/Treatment Referral|"Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months~Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement~Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)~Facebook Group: The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up."
11384523|NCT03598088|BG000|Baseline|All Enrolled Population|Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene and the Caya diaphragm throughout the course of the trial. The purpose of the Caya PCT cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated.
11384524|NCT03598088|FG000|Participant Flow|Healthy Sexually Active Women|"Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene (3 rings over 3 cycles (1 ring per cycle)) and the Caya diaphragm (to be used for intercourse at 1 time for 1 cycle) throughout the course of the trial. Each cycle was 28-35 days long. The purpose of the Caya PCT cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated.~Ovaprene: non-hormonal contraceptive ring"
11384525|NCT03598088|OG000|Outcome|Ovaprene Population|All Enrolled Participants that used the Ovaprene device during the study for one PCT cycle.
11384526|NCT03598088|OG000|Outcome|Ovaprene Population|All Enrolled Participants that used the Ovaprene device during the study.
11384527|NCT03598088|OG000|Outcome|Ovaprene Population, PCT A|All Enrolled Participants that used the Ovaprene device during OVP PCT Cycle A.
11384528|NCT03598088|OG001|Outcome|Ovaprene Population, PCT B|All Enrolled Participants that used the Ovaprene device during OVP PCT Cycle B.
11384529|NCT03598088|OG000|Outcome|Ovaprene Population|All Enrolled Participants that used the Ovaprene device
11384530|NCT03598088|OG000|Outcome|Ovaprene Population, Nugent Score|All Enrolled Participants that used the Ovaprene device
11202342|NCT02207244|FG001|Participant Flow|Guselkumab 100 mg (Week 0 - 16)|Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
11202343|NCT02207244|FG002|Participant Flow|Adalimumab (Week 0 - 16)|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
10799291|NCT02257736|FG001|Participant Flow|Apalutamide + Abiraterone Acetate - Prednisolone|Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799292|NCT02257736|OG000|Outcome|Placebo+ Abiraterone Acetate - Prednisolone|Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799293|NCT02257736|OG001|Outcome|Apalutamide + Abiraterone Acetate - Prednisolone|Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799294|NCT02257736|EG000|Reported Event|Placebo+ Abiraterone Acetate - Prednisolone|Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799295|NCT02257736|EG001|Reported Event|Apalutamide + Abiraterone Acetate - Prednisolone|Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
10799296|NCT02252172|BG000|Baseline|Lenalidomide + Dexamethasone (Rd)|Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
10799297|NCT02252172|BG001|Baseline|Daratumumab + Lenalidomide + Dexamethasone (DRd)|Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
10799298|NCT02252172|BG002|Baseline|Total|Total of all reporting groups
10799299|NCT02252172|FG000|Participant Flow|Lenalidomide + Dexamethasone (Rd)|Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
10799300|NCT02252172|FG001|Participant Flow|Daratumumab + Lenalidomide + Dexamethasone (DRd)|Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
10799301|NCT02252172|OG000|Outcome|Lenalidomide + Dexamethasone (Rd)|Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
10799302|NCT02252172|OG001|Outcome|Daratumumab + Lenalidomide + Dexamethasone (DRd)|Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
10799303|NCT02252172|EG000|Reported Event|Lenalidomide + Dexamethasone (Rd)|Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
10799304|NCT02252172|EG001|Reported Event|Daratumumab + Lenalidomide + Dexamethasone (DRd)|Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
10799305|NCT02240134|BG000|Baseline|Education Intervention (Tx1)|"The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.~Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently."
10803449|NCT04109222|EG001|Reported Event|Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years|Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
10803450|NCT04109222|EG002|Reported Event|Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years|Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
11202344|NCT02207244|FG003|Participant Flow|Placebo Then Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
10799306|NCT02240134|BG001|Baseline|Air Filtration Unit Treatment (Tx2)|"Within each randomly assigned home, a 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.~Air Filtration Unit Treatment (Tx2): A 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the high setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency."
10799307|NCT02240134|BG002|Baseline|Placebo Intervention (Tx3)|"Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.~Placebo Intervention (Tx3): Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
10799308|NCT02240134|BG003|Baseline|Total|Total of all reporting groups
10799309|NCT02240134|FG000|Participant Flow|Education Intervention (Tx1)|"The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.~Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently."
10799310|NCT02240134|FG001|Participant Flow|Air Filtration Unit Treatment (Tx2)|"Within each randomly assigned home, a 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.~Air Filtration Unit Treatment (Tx2): A 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the high setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency."
10799311|NCT02240134|FG002|Participant Flow|Placebo Intervention (Tx3)|"Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.~Placebo Intervention (Tx3): Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
10799312|NCT02240134|OG000|Outcome|Education Intervention (Tx1)|"The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.~Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently."
10799313|NCT02240134|OG001|Outcome|Air Filtration Unit Treatment (Tx2)|"Within each randomly assigned home, a 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.~Air Filtration Unit Treatment (Tx2): A 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the high setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency."
11196545|NCT02165202|OG000|Outcome|Rilpivirine|"Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."
10803451|NCT04046939|BG000|Baseline|Placebo BID|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.~Placebo: placebo twice daily oral dosing for up to 12 weeks"
11196546|NCT02165202|OG001|Outcome|Placebo|"Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit."
10799314|NCT02240134|OG002|Outcome|Placebo Intervention (Tx3)|"Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.~Placebo Intervention (Tx3): Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
10799315|NCT02240134|EG000|Reported Event|Education Intervention (Tx1)|"The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.~Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently."
10799316|NCT02240134|EG001|Reported Event|Air Filtration Unit Treatment (Tx2)|"Within each randomly assigned home, a 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.~Air Filtration Unit Treatment (Tx2): A 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the high setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency."
10799317|NCT02240134|EG002|Reported Event|Placebo Intervention (Tx3)|"Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.~Placebo Intervention (Tx3): Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
10799318|NCT02197234|BG000|Baseline|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
10799319|NCT02197234|FG000|Participant Flow|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
10799320|NCT02197234|OG000|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
10799321|NCT02197234|OG001|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
10799322|NCT02197234|EG000|Reported Event|Overall Safety Population|Parts A and B of the study combined.
10799323|NCT02197234|EG001|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.
10799324|NCT02197234|EG002|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
10799325|NCT02195479|BG000|Baseline|Velcade, Melphalan and Prednisone (VMP)|Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
10799326|NCT02195479|BG001|Baseline|Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)|Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
10799327|NCT02195479|BG002|Baseline|Total|Total of all reporting groups
10799328|NCT02195479|FG000|Participant Flow|Velcade, Melphalan and Prednisone (VMP)|Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
10799329|NCT02195479|FG001|Participant Flow|Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)|Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
10803452|NCT04046939|BG001|Baseline|37.5 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
10799330|NCT02195479|OG000|Outcome|Velcade, Melphalan and Prednisone (VMP)|Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
10799331|NCT02195479|OG001|Outcome|Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)|Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
10799332|NCT02195479|EG000|Reported Event|Velcade, Melphalan and Prednisone (VMP)|Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
10799333|NCT02195479|EG001|Reported Event|Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)|Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
10799334|NCT02158585|BG000|Baseline|Placebo|The placebo will match the lamotrigine dosage, frequency and duration.
10799335|NCT02158585|BG001|Baseline|Lamotrigine|Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
10799336|NCT02158585|BG002|Baseline|Total|Total of all reporting groups
10799337|NCT02158585|FG000|Participant Flow|Placebo|The placebo will match the lamotrigine dosage, frequency and duration.
10799338|NCT02158585|FG001|Participant Flow|Lamotrigine|Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
11202345|NCT02207244|FG004|Participant Flow|Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
11202346|NCT02207244|FG005|Participant Flow|Adalimumab (Week 16 - 28)|Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
10799339|NCT02158585|OG000|Outcome|Placebo|The placebo will match the lamotrigine dosage, frequency and duration.
10799340|NCT02158585|OG001|Outcome|Lamotrigine|Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
10799341|NCT02158585|OG000|Outcome|Lamotrigine|Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
10799342|NCT02158585|EG000|Reported Event|Placebo|The placebo will match the lamotrigine dosage, frequency and duration.
10799343|NCT02158585|EG001|Reported Event|Lamotrigine|Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, 100 mg twice a day and 150mg twice a day during titration; 150mg twice a day or 100mg twice a day for the 12-week study period; 150mg once a day, or 100mg once a day for Week 1 of the taper; and 75mg once a day, or 50mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
10799344|NCT02136134|BG000|Baseline|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10803453|NCT04046939|BG002|Baseline|75 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
10799345|NCT02136134|BG001|Baseline|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799346|NCT02136134|BG002|Baseline|Total|Total of all reporting groups
10799347|NCT02136134|FG000|Participant Flow|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799348|NCT02136134|FG001|Participant Flow|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799349|NCT02136134|OG000|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799350|NCT02136134|OG001|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799351|NCT02136134|EG000|Reported Event|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799352|NCT02136134|EG001|Reported Event|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
10799353|NCT02076009|BG000|Baseline|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
10799354|NCT02076009|BG001|Baseline|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
10799355|NCT02076009|BG002|Baseline|Total|Total of all reporting groups
10799356|NCT02076009|FG000|Participant Flow|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
10799357|NCT02076009|FG001|Participant Flow|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
10799358|NCT02076009|OG000|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
10803454|NCT04046939|BG003|Baseline|150 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
11196547|NCT02165202|EG000|Reported Event|Rilpivirine|"Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."
11241298|NCT02486263|OG000|Outcome|Study|"Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions~Study Arm - acid suppression plus feeding bundle: -Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)~Total fluid volume restriction (120-140 milliliters/kilogram/day)~Feeding duration over 30 minutes~Infant feeds with right side down~Infant is placed on back following feeds"
11337897|NCT03596177|FG000|Participant Flow|Placebo|Participants received subcutaneous (SC) injection of placebo for 16 days in the single-blind treatment period, and then SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period.
10799359|NCT02076009|OG001|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
10799360|NCT02076009|EG000|Reported Event|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
10799361|NCT02076009|EG001|Reported Event|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
10799362|NCT02043678|BG000|Baseline|Radium-223 Dichloride + Abi/Pred|Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
10799363|NCT02043678|BG001|Baseline|Placebo + Abi/Pred|Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
10799364|NCT02043678|BG002|Baseline|Total|Total of all reporting groups
10799365|NCT02043678|FG000|Participant Flow|Radium-223 Dichloride + Abi/Pred|Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
10799366|NCT02043678|FG001|Participant Flow|Placebo + Abi/Pred|Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
10799367|NCT02043678|OG000|Outcome|Radium-223 Dichloride + Abi/Pred|Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
10799368|NCT02043678|OG001|Outcome|Placebo + Abi/Pred|Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
10799369|NCT02043678|EG000|Reported Event|Radium-223 Dichloride + Abi/Pred|Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
10799370|NCT02043678|EG001|Reported Event|Placebo + Abi/Pred|Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
10799371|NCT01828099|BG000|Baseline|Ceritinib|Ceritinib 750 mg
10799372|NCT01828099|BG001|Baseline|Chemotherapy|Chemotherapy patients (Induction per Investigator's choice)
10799373|NCT01828099|BG002|Baseline|Total|Total of all reporting groups
10799374|NCT01828099|FG000|Participant Flow|Ceritinib|Ceritinib 750 mg
10799375|NCT01828099|FG001|Participant Flow|Chemotherapy|Chemotherapy patients (Induction per Investigator's choice)
10799376|NCT01828099|OG000|Outcome|Ceritinib|Ceritinib 750 mg
10799377|NCT01828099|OG001|Outcome|Chemotherapy|Chemotherapy patients (Induction per Investigator's choice)
11384531|NCT03598088|OG000|Outcome|Ovaprene Population, IL-1Beta|All Enrolled Participants that used the Ovaprene device
10799378|NCT01828099|EG000|Reported Event|Ceritinib|Ceritinib 750 mg
10799379|NCT01828099|EG001|Reported Event|Chemotherapy|Chemotherapy patients (Induction per Investigator's choice)
10799380|NCT01757535|BG000|Baseline|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
10799381|NCT01757535|BG001|Baseline|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
10799382|NCT01757535|BG002|Baseline|Total|Total of all reporting groups
10803455|NCT04046939|BG004|Baseline|Total|Total of all reporting groups
10799383|NCT01757535|FG000|Participant Flow|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
10799384|NCT01757535|FG001|Participant Flow|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
10799385|NCT01757535|OG000|Outcome|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
10799386|NCT01757535|OG001|Outcome|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
10799387|NCT01757535|EG000|Reported Event|Oral Azacitidine|Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
10799388|NCT01757535|EG001|Reported Event|Placebo|Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
10799389|NCT01719744|BG000|Baseline|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
10799390|NCT01719744|FG000|Participant Flow|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
10799391|NCT01719744|OG000|Outcome|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
10799392|NCT01719744|EG000|Reported Event|ENMD-2076|"ENMD-2076 capsules, 275 mg once daily, by mouth.~ENMD-2076"
10799393|NCT01684722|BG000|Baseline|Vitamin D + Fish Oil Placebo|"Vitamin D and fish oil placebo~Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day.~Fish oil placebo: Fish oil placebo"
10799394|NCT01684722|BG001|Baseline|Vitamin D Placebo + Fish Oil|"Vitamin D placebo and omega-3 fatty acids (fish oil)~Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).~Vitamin D placebo: Vitamin D3 placebo"
10799395|NCT01684722|BG002|Baseline|Vitamin D Placebo + Fish Oil Placebo|"Vitamin D placebo and fish oil placebo~Vitamin D placebo: Vitamin D3 placebo~Fish oil placebo: Fish oil placebo"
10799396|NCT01684722|BG003|Baseline|Vitamin D + Fish Oil|"Vitamin D and omega-3 fatty acids (fish oil)~Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day.~Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])."
10799397|NCT01684722|BG004|Baseline|Total|Total of all reporting groups
10799398|NCT01684722|FG000|Participant Flow|Vitamin D + Fish Oil Placebo|"Vitamin D and fish oil placebo~Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day.~Fish oil placebo: Fish oil placebo"
10799399|NCT01684722|FG001|Participant Flow|Vitamin D Placebo + Fish Oil|"Vitamin D placebo and omega-3 fatty acids (fish oil)~Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).~Vitamin D placebo: Vitamin D3 placebo"
10799400|NCT01684722|FG002|Participant Flow|Vitamin D Placebo + Fish Oil Placebo|"Vitamin D placebo and fish oil placebo~Vitamin D placebo: Vitamin D3 placebo~Fish oil placebo: Fish oil placebo"
10799401|NCT01684722|FG003|Participant Flow|Vitamin D + Fish Oil|"Vitamin D and omega-3 fatty acids (fish oil)~Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day.~Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])."
10799402|NCT01684722|OG000|Outcome|Vitamin D|Vitamin D 2000IU daily
10799403|NCT01684722|OG001|Outcome|Vitamin D Placebo|Matching placebo daily
10799404|NCT01684722|OG002|Outcome|Fish Oil|Fish oil one capsule daily
10799405|NCT01684722|OG003|Outcome|Fish Oil Placebo|Matching placebo daily
10799406|NCT01684722|OG000|Outcome|Vitamin D|Vitamin D3 (cholecalciferol), 2000 IU per day.
10799407|NCT01684722|OG001|Outcome|Vitamin D Placebo|Vitamin D placebo group
10799408|NCT01684722|OG002|Outcome|Fish Oil|Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10799409|NCT01684722|OG003|Outcome|Fish Oil Placebo|Fish oil placebo group
10799410|NCT01684722|OG000|Outcome|Vitamin D|Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day
10799411|NCT01684722|EG000|Reported Event|Vitamin D + Fish Oil Placebo|Vitamin D and fish oil placebo Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day. Fish oil placebo: Fish oil placebo
10799412|NCT01684722|EG001|Reported Event|Vitamin D Placebo + Fish Oil|"Vitamin D placebo and omega-3 fatty acids (fish oil) Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).~Vitamin D placebo: Vitamin D3 placebo"
11384532|NCT03598088|OG001|Outcome|Ovaprene Population, IL-8|All Enrolled Participants that used the Ovaprene device.
10799413|NCT01684722|EG002|Reported Event|Vitamin D Placebo + Fish Oil Placebo|Vitamin D placebo and fish oil placebo Vitamin D placebo: Vitamin D3 placebo Fish oil placebo: Fish oil placebo
10799414|NCT01684722|EG003|Reported Event|Vitamin D + Fish Oil|Vitamin D and omega-3 fatty acids (fish oil) Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day. Omega-3 fatty acids (fish oil): Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
10799415|NCT01615029|BG000|Baseline|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799416|NCT01615029|BG001|Baseline|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799417|NCT01615029|BG002|Baseline|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799418|NCT01615029|BG003|Baseline|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799419|NCT01615029|BG004|Baseline|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799420|NCT01615029|BG005|Baseline|Total|Total of all reporting groups
10799421|NCT01615029|FG000|Participant Flow|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799422|NCT01615029|FG001|Participant Flow|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799423|NCT01615029|FG002|Participant Flow|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799424|NCT01615029|FG003|Participant Flow|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799425|NCT01615029|FG004|Participant Flow|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
11241299|NCT02486263|OG001|Outcome|Conventional|"Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.~Conventional arm - acid suppression only: -Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)"
10799426|NCT01615029|OG000|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799427|NCT01615029|OG001|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
11384533|NCT03598088|OG002|Outcome|Ovaprene Population, SLPI|All Enrolled Participants that used the Ovaprene device.
10799428|NCT01615029|OG002|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799429|NCT01615029|OG003|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799430|NCT01615029|OG000|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799431|NCT01615029|EG000|Reported Event|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799432|NCT01615029|EG001|Reported Event|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799433|NCT01615029|EG002|Reported Event|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799434|NCT01615029|EG003|Reported Event|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799435|NCT01615029|EG004|Reported Event|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
10799436|NCT01516346|BG000|Baseline|Isosorbide Dinitrate|Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.
10799437|NCT01516346|BG001|Baseline|Isosorbide Dinitrate + Hydralazine|"Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Dosage of Hydralazine will be 37.5mg (if Stage 1) OR 75mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily, to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Isosorbide Dinitrate + Hydralazine: Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 hydralazine capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm."
10799438|NCT01516346|BG002|Baseline|Placebo|Placebo: Enrolled subjects will be randomized in a blinded fashion to 2 placebo capsules TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs.
10799439|NCT01516346|BG003|Baseline|Total|Total of all reporting groups
10799440|NCT01516346|FG000|Participant Flow|Isosorbide Dinitrate|Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.
10799441|NCT01516346|FG001|Participant Flow|Isosorbide Dinitrate + Hydralazine|"Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Dosage of Hydralazine will be 37.5mg (if Stage 1) OR 75mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing if they tolerate Stage 1 dosing. Frequency is three times daily, to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Isosorbide Dinitrate + Hydralazine: Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 hydralazine capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm."
10803456|NCT04046939|FG000|Participant Flow|Placebo BID|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.~Placebo: placebo twice daily oral dosing for up to 12 weeks"
10799442|NCT01516346|FG002|Participant Flow|Placebo|Placebo: Enrolled subjects will be randomized in a blinded fashion to 2 placebo capsules TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs.
10799443|NCT01516346|OG000|Outcome|Isosorbide Dinitrate|Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.
10799444|NCT01516346|OG001|Outcome|Isosorbide Dinitrate + Hydralazine|"Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Dosage of Hydralazine will be 37.5mg (if Stage 1) OR 75mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing if they tolerate Stage 1 dosing. Frequency is three times daily, to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Isosorbide Dinitrate + Hydralazine: Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 hydralazine capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm."
10799445|NCT01516346|OG002|Outcome|Placebo|Placebo: Enrolled subjects will be randomized in a blinded fashion to 2 placebo capsules TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs.
10799446|NCT01516346|EG000|Reported Event|Isosorbide Dinitrate|"Research pharmacy-formulated capsules will be given to the subjects in two bottles. For this interventional arm, one of the bottles will contain the active ingredient Isosorbide Dinitrate and the other will contain placebo capsules.~Dosage of Isosorbide Dinitrate will be 20mg (if Stage 1) OR 40mg (if Stage 2). All the subjects will be uptitrated to Stage 2 dosing, if they tolerate Stage 1 dosing. Frequency is three times daily to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Isosorbide Dinitrate: Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 placebo capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm."
10799447|NCT01516346|EG001|Reported Event|Isosorbide Dinitrate + Hydralazine|Isosorbide Dinitrate + Hydralazine: Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 hydralazine capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm. Subjects receiving hydralazine will be given 37.5mg PO q8am, 2pm, and 8pm and will be titrated up to 75mg PO q8am, 2pm, and 8pm.
10799448|NCT01516346|EG002|Reported Event|Placebo|"Research pharmacy-formulated capsules will be given to subjects in two bottles. For this interventional arm, both the bottles will contain placebo capsules.~Dosage will be same regardless of up-titration from Stage 1 dosing to Stage 2 dosing. Frequency is three times daily, to be taken at 8 AM, 2 PM and 8 PM. Duration is for 24 weeks.~Placebo: Enrolled subjects will be randomized in a blinded fashion to 2 placebo capsules TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs."
10799449|NCT01399372|BG000|Baseline|Chemotherapy|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799450|NCT01399372|BG001|Baseline|Chemotherapy + Low-Dose WBRT|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799451|NCT01399372|BG002|Baseline|Total|Total of all reporting groups
10799452|NCT01399372|FG000|Participant Flow|Chemotherapy|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
11196548|NCT02165202|EG001|Reported Event|Placebo|"Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).~Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit."
10799453|NCT01399372|FG001|Participant Flow|Chemotherapy + Low-Dose WBRT|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799454|NCT01399372|OG000|Outcome|Chemotherapy|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799455|NCT01399372|OG001|Outcome|Chemotherapy + Low-Dose WBRT|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799456|NCT01399372|EG000|Reported Event|Chemotherapy|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
10803457|NCT04046939|FG001|Participant Flow|37.5 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
10799457|NCT01399372|EG001|Reported Event|Chemotherapy + Low-Dose WBRT|Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
10799458|NCT01314118|BG000|Baseline|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
10799459|NCT01314118|FG000|Participant Flow|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
10799460|NCT01314118|OG000|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
10799461|NCT01314118|EG000|Reported Event|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
10799462|NCT01303796|BG000|Baseline|Sapacitabine-decitabine Alternating|"Arm A sapacitabine administered in alternating cycles with decitabine~Sapacitabine: Oral sapacitabine capsules~Decitabine: Decitabine intravenous"
10799463|NCT01303796|BG001|Baseline|Decitabine|"Arm C Decitabine~Decitabine: Decitabine intravenous"
10799464|NCT01303796|BG002|Baseline|Total|Total of all reporting groups
10799465|NCT01303796|FG000|Participant Flow|Lead In Phase|Decitabine alternating with sapacitabine (n=21). Patients followed for safety. Lead in group is not included in ITT analysis of randomized portion of the trial.
10799466|NCT01303796|FG001|Participant Flow|Sapacitabine-decitabine Alternating|"Arm A patients received sapacitabine capsules in alternating cycles with decitabine i.e., Cycle 1=decitabine, Cycle 2=sapacitabine, Cycle 3=decitabine, Cycle 4=sapacitabine, etc. Arm A is preceded by a Lead-in phase in selected patients.~Sapacitabine: Oral capsules; 300 mg twice daily (b.i.d.) orally x 3 consecutive days/week x 2 weeks every 8 weeks Decitabine: Decitabine intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor."
10799467|NCT01303796|FG002|Participant Flow|Decitabine|"Arm C patients received decitabine infusion.~Decitabine: Intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks~Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment that it was in the best interest of the patient to withdraw; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor."
10799468|NCT01303796|OG000|Outcome|Sapacitabine-decitabine Alternating|"Arm A sapacitabine administered in alternating cycles with decitabine~Sapacitabine: Oral sapacitabine capsules~Decitabine: Decitabine intravenous"
10799469|NCT01303796|OG001|Outcome|Decitabine|"Arm C Decitabine~Decitabine: Decitabine intravenous"
10799470|NCT01303796|EG000|Reported Event|Lead In Phase|"Sapacitabine administered in alternating cycles with decitabine~Sapacitabine: Oral sapacitabine capsules~Decitabine: Decitabine intravenous~(n=21, not included in randomization)"
10799471|NCT01303796|EG001|Reported Event|Sapacitabine-decitabine Alternating|"Arm A sapacitabine administered in alternating cycles with decitabine~Sapacitabine: Oral sapacitabine capsules~Decitabine: Decitabine intravenous"
10799472|NCT01303796|EG002|Reported Event|Decitabine|"Arm C Decitabine~Decitabine: Decitabine intravenous"
11196549|NCT02165384|BG000|Baseline|Hummingbird TTS|Treatment only surgical instrument study
10799473|NCT01235923|BG000|Baseline|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
10799474|NCT01235923|BG001|Baseline|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
10799475|NCT01235923|BG002|Baseline|Total|Total of all reporting groups
10799476|NCT01235923|FG000|Participant Flow|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
10799477|NCT01235923|FG001|Participant Flow|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
10799478|NCT01235923|OG000|Outcome|Weekly Epo|
10799479|NCT01235923|OG001|Outcome|Three Times a Week Epo|
11196550|NCT02165384|FG000|Participant Flow|Hummingbird TTS|Treatment only surgical instrument study
11196551|NCT02165384|OG000|Outcome|Hummingbird TTS|Treatment only HTTS was used to make incision and deliver ear tube
11196552|NCT02165384|EG000|Reported Event|Hummingbird TTS|Treatment only HTTS was used to make incision and deliver ear tube
10799480|NCT01235923|EG000|Reported Event|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
10799481|NCT01235923|EG001|Reported Event|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
10799482|NCT01171898|BG000|Baseline|Dose Escalation Cohort (Phase 1)|Participants received apalutamide at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily (up to 240 mg once daily and at higher doses of 300/390/480 mg twice daily dosing). Once Recommended Phase 2 Dose (RP2D) was selected, Phase 1 participants being treated at the lower dose levels were allowed to escalate to the RP2D level (240 mg) at the discretion of the primary investigator.
10799483|NCT01171898|BG001|Baseline|Cohort 1: Non-metastatic CRPC (Phase 2)|Participants with non-metastatic, treatment naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) enrolled in Cohort 1 of Phase 2, received apalutamide at Maximum Tolerated Dose (MTD) and/or RP2D of 240 mg, determined in Phase 1.
10799484|NCT01171898|BG002|Baseline|Cohort 2: Treatment-naive Metastatic CRPC (Phase 2)|CRPC (Phase 2) Participants with metastatic CRPC who had not received chemotherapy for metastatic disease or prior abiraterone acetate (treatmentnaive) were enrolled in Cohort 2 of Phase 2, received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799485|NCT01171898|BG003|Baseline|Cohort 3: Post-Abiraterone Metastatic CRPC (Phase 2)|Participants with metastatic CRPC that were chemotherapynaive, but had been previously treated with abiraterone acetate enrolled in Cohort 3 of Phase 2 received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799486|NCT01171898|BG004|Baseline|Total|Total of all reporting groups
11384534|NCT03598088|OG000|Outcome|All Enrolled Population|Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization.
11384535|NCT03598088|OG000|Outcome|Ovaprene Population at BP3|All Enrolled Participants that used the Ovaprene device
11384536|NCT03598088|OG001|Outcome|Ovaprene Population at OS1|All Enrolled Participants that used the Ovaprene device
11384537|NCT03598088|OG002|Outcome|Ovaprene Population at OP1A|All Enrolled Participants that used the Ovaprene device
10799487|NCT01171898|FG000|Participant Flow|Dose Escalation Cohort (Phase 1)|Participants received apalutamide (ARN-509) at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily (up to 240 mg once daily and at higher doses of 300/390/480 mg twice daily dosing). Once Recommended Phase 2 Dose (RP2D) was selected, Phase 1 participants being treated at the lower dose levels were allowed to escalate to the RP2D level (240 mg) at the discretion of the primary investigator.
10799488|NCT01171898|FG001|Participant Flow|Cohort 1: Non-metastatic CRPC (Phase 2)|Participants with non-metastatic, treatment naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) enrolled in Cohort 1 of Phase 2, received apalutamide at Maximum Tolerated Dose (MTD) and/or RP2D of 240 mg, determined in Phase 1.
10799489|NCT01171898|FG002|Participant Flow|Cohort 2: Treatment-naive Metastatic CRPC (Phase 2)|CRPC (Phase 2) Participants with metastatic CRPC who had not received chemotherapy for metastatic disease or prior abiraterone acetate (treatmentnaive) were enrolled in Cohort 2 of Phase 2, received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799490|NCT01171898|FG003|Participant Flow|Cohort 3: Post-Abiraterone Metastatic CRPC (Phase 2)|Participants with metastatic CRPC that were chemotherapynaive, but had been previously treated with abiraterone acetate enrolled in Cohort 3 of Phase 2 received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799491|NCT01171898|OG000|Outcome|Dose Escalation Cohort (Phase 1)|Participants received apalutamide at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily (up to 240 mg once daily and at higher doses of 300/390/480 mg twice daily dosing). Once Recommended Phase 2 Dose (RP2D) was selected, Phase 1 participants being treated at the lower dose levels were allowed to escalate to the RP2D level (240 mg) at the discretion of the primary investigator.
10799492|NCT01171898|OG001|Outcome|Cohort 1: Non-metastatic CRPC (Phase 2)|Participants with non-metastatic, treatment naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) enrolled in Cohort 1 of Phase 2, received apalutamide at Maximum Tolerated Dose (MTD) and/or RP2D of 240 mg, determined in Phase 1.
10799493|NCT01171898|OG002|Outcome|Cohort 2: Treatment-naive Metastatic CRPC (Phase 2)|Participants with metastatic CRPC who had not received chemotherapy for metastatic disease or prior abiraterone acetate (treatment-naive) were enrolled in Cohort 2 of Phase 2, received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799494|NCT01171898|OG003|Outcome|Cohort 3: Post-Abiraterone Metastatic CRPC (Phase 2)|Participants with metastatic CRPC that were chemotherapy-naive, but had been previously treated with abiraterone acetate enrolled in Cohort 3 of Phase 2 received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
11384538|NCT03598088|OG003|Outcome|Ovaprene Population at OP2A|All Enrolled Participants that used the Ovaprene device
11384539|NCT03598088|OG004|Outcome|Ovaprene Population at OP1B|All Enrolled Participants that used the Ovaprene device
11384540|NCT03598088|OG005|Outcome|Ovaprene Population at Unscheduled Visit|All Enrolled Participants that used the Ovaprene device
11384541|NCT03598088|OG000|Outcome|Ovaprene Population at Screening|All Enrolled Participants that used the Ovaprene device
11384542|NCT03598088|OG001|Outcome|Ovaprene Population at BP3|All Enrolled Participants that used the Ovaprene device
11384543|NCT03598088|OG002|Outcome|Ovaprene Population at OS1|All Enrolled Participants that used the Ovaprene device
11384544|NCT03598088|OG003|Outcome|Ovaprene Population at OS2|All Enrolled Participants that used the Ovaprene device
11384545|NCT03598088|OG004|Outcome|Ovaprene Population at OS3|All Enrolled Participants that used the Ovaprene device
11384546|NCT03598088|OG005|Outcome|Ovaprene Population at OS4|All Enrolled Participants that used the Ovaprene device
11384547|NCT03598088|OG006|Outcome|Ovaprene Population at OS5|All Enrolled Participants that used the Ovaprene device
11384548|NCT03598088|OG007|Outcome|Ovaprene Population at OP1A|All Enrolled Participants that used the Ovaprene device
11384549|NCT03598088|OG008|Outcome|Ovaprene Population at OP2A|All Enrolled Participants that used the Ovaprene device
11384550|NCT03598088|OG009|Outcome|Ovaprene Population at OP3A|All Enrolled Participants that used the Ovaprene device
10799495|NCT01171898|OG000|Outcome|Cohort 1: Non-metastatic CRPC (Phase 2)|Participants with non-metastatic, treatment naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) enrolled in Cohort 1 of Phase 2, received apalutamide at Maximum Tolerated Dose (MTD) and/or RP2D of 240 mg, determined in Phase 1.
10799496|NCT01171898|OG001|Outcome|Cohort 2: Treatment-naive Metastatic CRPC (Phase 2)|Participants with metastatic CRPC who had not received chemotherapy for metastatic disease or prior abiraterone acetate (treatment-naive) were enrolled in Cohort 2 of Phase 2, received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799497|NCT01171898|OG002|Outcome|Cohort 3: Post-Abiraterone Metastatic CRPC (Phase 2)|Participants with metastatic CRPC that were chemotherapy-naive, but had been previously treated with abiraterone acetate enrolled in Cohort 3 of Phase 2 received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799498|NCT01171898|EG000|Reported Event|Dose Escalation Cohort (Phase 1)|Participants received apalutamide at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily (up to 240 mg once daily and at higher doses of 300/390/480 mg twice daily dosing). Once Recommended Phase 2 Dose (RP2D) was selected, Phase 1 participants being treated at the lower dose levels were allowed to escalate to the RP2D level (240 mg) at the discretion of the primary investigator.
10799499|NCT01171898|EG001|Reported Event|Cohort 1: Non-metastatic CRPC (Phase 2)|Participants with non-metastatic, treatment naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) enrolled in Cohort 1 of Phase 2, received apalutamide at Maximum Tolerated Dose (MTD) and/or RP2D of 240 mg, determined in Phase 1.
10799500|NCT01171898|EG002|Reported Event|Cohort 2: Treatment-naive Metastatic CRPC (Phase 2)|CRPC (Phase 2) Participants with metastatic CRPC who had not received chemotherapy for metastatic disease or prior abiraterone acetate (treatmentnaive) were enrolled in Cohort 2 of Phase 2, received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799501|NCT01171898|EG003|Reported Event|Cohort 3: Post-Abiraterone Metastatic CRPC (Phase 2)|Participants with metastatic CRPC that were chemotherapynaive, but had been previously treated with abiraterone acetate enrolled in Cohort 3 of Phase 2 received apalutamide at MTD and/or RP2D of 240 mg, determined in Phase 1.
10799502|NCT01120964|BG000|Baseline|Intravenous L-Citrulline|"IV bolus of 150 mg/kg L-citrulline at the initiation of bypass, followed by L-citrulline (200 μmol/L) addition to the filtration or hemoconcentration replacement fluid used during bypass. Plus L-citrulline (20 mg/kg) bolus 30 minutes after decannulation from bypass, immediately followed by 9 mg/kg/h continuous L-citrulline infusion for 48 hours.~Intravenous L-Citrulline"
10799503|NCT01120964|BG001|Baseline|Placebo of Intravenous L-Citrulline|"Placebo administered according to the same schedule as L-citrulline~Placebo of Intravenous L-Citrulline: Placebo of intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug"
10799504|NCT01120964|BG002|Baseline|Total|Total of all reporting groups
10799505|NCT01120964|FG000|Participant Flow|Intravenous L-Citrulline|"IV bolus of 150 mg/kg L-citrulline at the initiation of bypass, followed by L-citrulline (200 μmol/L) addition to the filtration or hemoconcentration replacement fluid used during bypass. Plus L-citrulline (20 mg/kg) bolus 30 minutes after decannulation from bypass, immediately followed by 9 mg/kg/h continuous L-citrulline infusion for 48 hours.~Intravenous L-Citrulline"
10799506|NCT01120964|FG001|Participant Flow|Placebo of Intravenous L-Citrulline|"Placebo administered according to the same schedule as L-citrulline~Placebo of Intravenous L-Citrulline: Placebo of intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug"
10799507|NCT01120964|OG000|Outcome|Intravenous L-Citrulline|"IV bolus of 150 mg/kg L-citrulline at the initiation of bypass, followed by L-citrulline (200 μmol/L) addition to the filtration or hemoconcentration replacement fluid used during bypass. Plus L-citrulline (20 mg/kg) bolus 30 minutes after decannulation from bypass, immediately followed by 9 mg/kg/h continuous L-citrulline infusion for 48 hours.~Intravenous L-Citrulline"
10799508|NCT01120964|OG001|Outcome|Placebo of Intravenous L-Citrulline|"Placebo administered according to the same schedule as L-citrulline~Placebo of Intravenous L-Citrulline: Placebo of intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug"
10799509|NCT01120964|EG000|Reported Event|Intravenous L-Citrulline|"IV bolus of 150 mg/kg L-citrulline at the initiation of bypass, followed by L-citrulline (200 μmol/L) addition to the filtration or hemoconcentration replacement fluid used during bypass. Plus L-citrulline (20 mg/kg) bolus 30 minutes after decannulation from bypass, immediately followed by 9 mg/kg/h continuous L-citrulline infusion for 48 hours.~Intravenous L-Citrulline"
10799510|NCT01120964|EG001|Reported Event|Placebo of Intravenous L-Citrulline|"Placebo administered according to the same schedule as L-citrulline~Placebo of Intravenous L-Citrulline: Placebo of intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug"
10799511|NCT01082211|BG000|Baseline|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
10799512|NCT01082211|FG000|Participant Flow|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
10799513|NCT01082211|OG000|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
10799514|NCT01082211|OG000|Outcome|Functional Score|Patient-Reported: 12-Month Functional Score
10799515|NCT01082211|OG001|Outcome|Cosmetic Score|Patient-Reported: 12-Month Cosmetic Score
10799516|NCT01082211|OG002|Outcome|Breast-Specific Pain Score|Patient-Reported: 12-Month Breast-Specific Pain Score
10799517|NCT01082211|EG000|Reported Event|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
10799518|NCT01080196|BG000|Baseline|RENEW|"RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
10799519|NCT01080196|BG001|Baseline|TRADITIONAL|"The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A target resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period."
10799520|NCT01080196|BG002|Baseline|Total|Total of all reporting groups
10799521|NCT01080196|FG000|Participant Flow|RENEW|"RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
10799522|NCT01080196|FG001|Participant Flow|TRADITIONAL|"The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their multicomponent exercise fall reduction program (MCERFP). The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (1RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A target resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period."
10799523|NCT01080196|OG000|Outcome|RENEW|"RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
10799524|NCT01080196|OG001|Outcome|TRADITIONAL|"The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A target resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period."
10799525|NCT01080196|OG000|Outcome|RENEW|"Resistance Exercise via Negative Work (RENEW) will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
10799526|NCT01080196|OG001|Outcome|TRADITIONAL|"The Traditional (TRAD) group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A target resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period."
10799527|NCT01080196|EG000|Reported Event|RENEW|"RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
10799528|NCT01080196|EG001|Reported Event|TRADITIONAL|"The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their MCERFP. The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A target resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period."
11196553|NCT02165397|BG000|Baseline|Ibrutinib + Rituximab|"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11384551|NCT03598088|OG010|Outcome|Ovaprene Population at OP4A|All Enrolled Participants that used the Ovaprene device
10799529|NCT00976911|BG000|Baseline|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
10799530|NCT00976911|BG001|Baseline|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
10799531|NCT00976911|BG002|Baseline|Total|Total of all reporting groups
10799532|NCT00976911|FG000|Participant Flow|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
10799533|NCT00976911|FG001|Participant Flow|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
10799534|NCT00976911|OG000|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
10799535|NCT00976911|OG001|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
10799536|NCT00976911|EG000|Reported Event|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
10799537|NCT00976911|EG001|Reported Event|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
10799538|NCT00746590|BG000|Baseline|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
10799539|NCT00746590|FG000|Participant Flow|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
10799540|NCT00746590|OG000|Outcome|Prolarix Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
10799541|NCT00746590|EG000|Reported Event|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
10799542|NCT00712582|BG000|Baseline|Consolidation A|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is < 80% will receive 3 cycles of standard dose ICE Chemotherapy.~Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one."
10799543|NCT00712582|BG001|Baseline|Consolidation B|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).~Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles."
10799544|NCT00712582|BG002|Baseline|Consolidation C|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic[m3] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic[m4] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.~Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.~Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital."
10799545|NCT00712582|BG003|Baseline|Total|Total of all reporting groups
10799546|NCT00712582|FG000|Participant Flow|Consolidation A|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is < 80% will receive 3 cycles of standard dose ICE Chemotherapy.~Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one."
10799547|NCT00712582|FG001|Participant Flow|Consolidation B|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).~Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles."
10799548|NCT00712582|FG002|Participant Flow|Consolidation C|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic[m3] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic[m4] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.~Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.~Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital."
10799549|NCT00712582|OG000|Outcome|Consolidation A|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is < 80% will receive 3 cycles of standard dose ICE Chemotherapy.~Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one."
10799550|NCT00712582|OG001|Outcome|Consolidation B|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).~Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles."
10799551|NCT00712582|OG002|Outcome|Consolidation C|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic[m3] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic[m4] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.~Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.~Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital."
11384552|NCT03598088|OG011|Outcome|Ovaprene Population at OP5A|All Enrolled Participants that used the Ovaprene device
10799552|NCT00712582|EG000|Reported Event|Consolidation A|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is < 80% will receive 3 cycles of standard dose ICE Chemotherapy.~Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one."
10799553|NCT00712582|EG001|Reported Event|Consolidation B|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).~Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles."
10799554|NCT00712582|EG002|Reported Event|Consolidation C|"Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.~Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic[m3] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic[m4] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.~Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.~Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital."
10799555|NCT00693238|BG000|Baseline|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
10799556|NCT00693238|BG001|Baseline|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
10799557|NCT00693238|BG002|Baseline|Total|Total of all reporting groups
10799558|NCT00693238|FG000|Participant Flow|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
10799559|NCT00693238|FG001|Participant Flow|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
10799560|NCT00693238|OG000|Outcome|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
10799561|NCT00693238|OG001|Outcome|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
10799562|NCT00693238|EG000|Reported Event|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
10799563|NCT00693238|EG001|Reported Event|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
10799564|NCT00679783|BG000|Baseline|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
10799565|NCT00679783|BG001|Baseline|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
10799566|NCT00679783|BG002|Baseline|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799567|NCT00679783|BG003|Baseline|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799568|NCT00679783|BG004|Baseline|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
10799569|NCT00679783|BG005|Baseline|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)"
10799570|NCT00679783|BG006|Baseline|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
10799571|NCT00679783|BG007|Baseline|Total|Total of all reporting groups
10799572|NCT00679783|FG000|Participant Flow|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
10799573|NCT00679783|FG001|Participant Flow|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
10799574|NCT00679783|FG002|Participant Flow|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799575|NCT00679783|FG003|Participant Flow|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799576|NCT00679783|FG004|Participant Flow|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
10799577|NCT00679783|FG005|Participant Flow|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)"
10799578|NCT00679783|FG006|Participant Flow|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
11384553|NCT03598088|OG012|Outcome|Ovaprene Population at OP1B|All Enrolled Participants that used the Ovaprene device
10799579|NCT00679783|OG000|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
10799580|NCT00679783|OG001|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
10799581|NCT00679783|OG002|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799582|NCT00679783|OG003|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799583|NCT00679783|OG004|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
10799584|NCT00679783|OG005|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)"
10799585|NCT00679783|OG006|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
11241300|NCT02486263|EG000|Reported Event|Study|"Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions~Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)~Total fluid volume restriction (120-140 milliliters/kilogram/day)~Feeding duration over 30 minutes~Infant feeds with right side down~Infant is placed on back following feeds"
10799586|NCT00679783|EG000|Reported Event|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
10799587|NCT00679783|EG001|Reported Event|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
10799588|NCT00679783|EG002|Reported Event|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799589|NCT00679783|EG003|Reported Event|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
10799590|NCT00679783|EG004|Reported Event|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
10799591|NCT00679783|EG005|Reported Event|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)"
10799592|NCT00679783|EG006|Reported Event|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
10799593|NCT00573131|BG000|Baseline|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799594|NCT00573131|BG001|Baseline|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799595|NCT00573131|BG002|Baseline|Total|Total of all reporting groups
10799596|NCT00573131|FG000|Participant Flow|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799597|NCT00573131|FG001|Participant Flow|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799598|NCT00573131|OG000|Outcome|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799599|NCT00573131|OG001|Outcome|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799600|NCT00573131|EG000|Reported Event|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799601|NCT00573131|EG001|Reported Event|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
10799602|NCT00533949|BG000|Baseline|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799603|NCT00533949|BG001|Baseline|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799604|NCT00533949|BG002|Baseline|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799605|NCT00533949|BG003|Baseline|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799606|NCT00533949|BG004|Baseline|Total|Total of all reporting groups
10799607|NCT00533949|FG000|Participant Flow|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799608|NCT00533949|FG001|Participant Flow|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799609|NCT00533949|FG002|Participant Flow|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799610|NCT00533949|FG003|Participant Flow|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799611|NCT00533949|OG000|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)
10799612|NCT00533949|OG001|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
10799613|NCT00533949|OG002|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
10799614|NCT00533949|OG003|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
10799615|NCT00533949|OG000|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
10799616|NCT00533949|OG000|Outcome|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799617|NCT00533949|OG001|Outcome|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799618|NCT00533949|OG002|Outcome|60 Gy RT + Cetuximab|60 gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799619|NCT00533949|OG003|Outcome|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799620|NCT00533949|OG000|Outcome|EGFR H-Score < 200|
10799621|NCT00533949|OG001|Outcome|EGFR H-Score >= 200|
10799622|NCT00533949|OG000|Outcome|All Patients|
10799623|NCT00533949|EG000|Reported Event|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799624|NCT00533949|EG001|Reported Event|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
10799625|NCT00533949|EG002|Reported Event|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799626|NCT00533949|EG003|Reported Event|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
10799627|NCT00529763|BG000|Baseline|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799628|NCT00529763|BG001|Baseline|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799629|NCT00529763|BG002|Baseline|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799630|NCT00529763|BG003|Baseline|Total|Total of all reporting groups
10799631|NCT00529763|FG000|Participant Flow|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799632|NCT00529763|FG001|Participant Flow|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799633|NCT00529763|FG002|Participant Flow|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799634|NCT00529763|OG000|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799635|NCT00529763|OG000|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799636|NCT00529763|OG001|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10803458|NCT04046939|FG002|Participant Flow|75 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
11241301|NCT02486263|EG001|Reported Event|Conventional|Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
11384554|NCT03598088|OG013|Outcome|Ovaprene Population At OP2B|All Enrolled Participants that used the Ovaprene device
11384555|NCT03598088|OG014|Outcome|Ovaprene Population at OP3B|All Enrolled Participants that used the Ovaprene device
11384556|NCT03598088|OG015|Outcome|Ovaprene Population at OP4B|All Enrolled Participants that used the Ovaprene device
11384557|NCT03598088|OG016|Outcome|Ovaprene Population at OP5B|All Enrolled Participants that used the Ovaprene device
11384558|NCT03598088|EG000|Reported Event|Ovaprene Device|All Enrolled Participants that used the Ovaprene device
11384559|NCT03598088|EG001|Reported Event|Caya Cycle|All Enrolled Participants that used the Caya diaphragm.
11384560|NCT03408444|BG000|Baseline|Test 1|Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
11384561|NCT03408444|BG001|Baseline|Test 2|Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
11384562|NCT03408444|BG002|Baseline|Test 3|Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
11384563|NCT03408444|BG003|Baseline|Control|Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
11384564|NCT03408444|BG004|Baseline|Total|Total of all reporting groups
11384565|NCT03408444|FG000|Participant Flow|Test 1|Subjects randomized to receive senofilcon A (Test 1) lens throughout the entire duration of the study
11384566|NCT03408444|FG001|Participant Flow|Test 2|Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
11384567|NCT03408444|FG002|Participant Flow|Test 3|Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
11384568|NCT03408444|FG003|Participant Flow|Control|Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
11384569|NCT03408444|OG000|Outcome|Test 1|Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
11384570|NCT03408444|OG001|Outcome|Test 2|Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
11384571|NCT03408444|OG002|Outcome|Test 3|Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
11384572|NCT03408444|OG003|Outcome|Control|Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
11384573|NCT03408444|EG000|Reported Event|Test 1|Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
11384574|NCT03408444|EG001|Reported Event|Test 2|Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
11384575|NCT03408444|EG002|Reported Event|Test 3|Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
11384576|NCT03408444|EG003|Reported Event|Control|Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
11241302|NCT02486302|BG000|Baseline|Etanercept|All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10803459|NCT04046939|FG003|Participant Flow|150 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
11196554|NCT02165397|BG001|Baseline|Placebo + Rituximab|"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196555|NCT02165397|BG002|Baseline|Open-Label Substudy: Ibrutinib|Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
11196556|NCT02165397|BG003|Baseline|Total|Total of all reporting groups
11196557|NCT02165397|FG000|Participant Flow|Ibrutinib + Rituximab|"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 intravenous (IV) per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196558|NCT02165397|FG001|Participant Flow|Placebo + Rituximab|"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196559|NCT02165397|FG002|Participant Flow|Open-Label Substudy: Ibrutinib|Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
11196560|NCT02165397|OG000|Outcome|Ibrutinib + Rituximab|"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11384577|NCT03282123|BG000|Baseline|MDMA-assisted Psychotherapy|"Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later~MDMA: 80 to 120 mg MDMA~Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session"
11384578|NCT03282123|FG000|Participant Flow|MDMA-assisted Psychotherapy|"Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later~MDMA: 80 to 120 mg MDMA~Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session"
11384579|NCT03282123|OG000|Outcome|MDMA-assisted Therapy|"Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later~MDMA: 80 to 120 mg MDMA~Psychotherapy: Non-directive therapy conducted during MDMA-assisted therapy session"
11384580|NCT03282123|OG000|Outcome|MDMA-assisted Psychotherapy|"Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later~MDMA: 80 to 120 mg MDMA~Psychotherapy: Non-directive therapy conducted during MDMA-assisted therapy session"
11384581|NCT03282123|EG000|Reported Event|MDMA-assisted Psychotherapy|"Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later~MDMA: 80 to 120 mg MDMA~Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session"
11384582|NCT03112590|BG000|Baseline|Phase 1 Level 1|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 50 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384583|NCT03112590|BG001|Baseline|Phase 1 Level 2|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384584|NCT03112590|BG002|Baseline|Phase 2|"Interferon-gamma (IFN-γ): Phase 2: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384585|NCT03112590|BG003|Baseline|Total|Total of all reporting groups
11384586|NCT03112590|FG000|Participant Flow|Phase 1 Level 1|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 50 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
10799637|NCT00529763|OG000|Outcome|CP CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799638|NCT00529763|OG002|Outcome|Total|All treated Participants with Advanced Disease CML - Accelerated Phase (AP) and Blast Phase/PH+ ALL
10799639|NCT00529763|OG000|Outcome|Chronic Phase (CP) CML|Participants with Ph+ CP CML who have received prior treatment with Imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants with chronic phase CML with QD dosing were permitted to take their dose either in the morning or evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799640|NCT00529763|OG001|Outcome|Accelerated CML|Participants with Ph+ AP who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance.Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799641|NCT00529763|OG002|Outcome|Blast Phase CML/Ph+ ALL|Participants with MyBP or LyBP CML or Ph+ALL who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799642|NCT00529763|OG000|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
10799643|NCT00529763|OG001|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
10799644|NCT00529763|EG000|Reported Event|Accelerated Phase|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799645|NCT00529763|EG001|Reported Event|Blast Phase / Ph+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799646|NCT00529763|EG002|Reported Event|Chronic Phase|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
10799647|NCT00479765|BG000|Baseline|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
10799648|NCT00479765|FG000|Participant Flow|OncoGel|"OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
10799649|NCT00479765|OG000|Outcome|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
10803460|NCT04046939|OG000|Outcome|Placebo BID|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.~Placebo: placebo twice daily oral dosing for up to 12 weeks"
11196561|NCT02165397|OG001|Outcome|Placebo + Rituximab|"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196562|NCT02165397|OG002|Outcome|Open-Label Substudy: Ibrutinib|Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
11196563|NCT02165397|OG000|Outcome|Ibrutinib + Rituximab|"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196564|NCT02165397|OG001|Outcome|Placebo + Rituximab|"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11241303|NCT02486302|FG000|Participant Flow|Etanercept|All participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), or plaque psoriasis (PsO) taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799650|NCT00479765|EG000|Reported Event|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
10799651|NCT00450411|BG000|Baseline|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
10799652|NCT00450411|FG000|Participant Flow|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
10799653|NCT00450411|OG000|Outcome|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
10799654|NCT00450411|EG000|Reported Event|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
10799655|NCT00412880|BG000|Baseline|BI 2536 200 mg|Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
10799656|NCT00412880|FG000|Participant Flow|BI 2536 200 mg|Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
10799657|NCT00412880|OG000|Outcome|BI 2536 200 mg|Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
10799658|NCT00412880|EG000|Reported Event|BI 2536 200 mg|Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
10799659|NCT00376623|BG000|Baseline|200 Milligram (mg) BI 2536 (Day 1)|A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10803461|NCT04046939|OG001|Outcome|37.5 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
11196565|NCT02165397|EG000|Reported Event|Ibrutinib + Rituximab|"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196566|NCT02165397|EG001|Reported Event|Placebo + Rituximab|"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.~Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab."
11196567|NCT02165397|EG002|Reported Event|Open-Label Substudy: Ibrutinib|Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.
11196568|NCT02165462|BG000|Baseline|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
11196569|NCT02165462|FG000|Participant Flow|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
11196570|NCT02165462|OG000|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
11196571|NCT02165462|EG000|Reported Event|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
11196572|NCT02165605|BG000|Baseline|Hylacare-Experimental|HylaCare cream-Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. The patient is her own control.
11241304|NCT02486302|OG000|Outcome|Etanercept|All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799660|NCT00376623|BG001|Baseline|50 Milligram BI 2536 (Day 1 - Day 3)|A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799661|NCT00376623|BG002|Baseline|60 Milligram BI 2536 (Day 1 - Day 3)|After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799662|NCT00376623|BG003|Baseline|Total|Total of all reporting groups
10799663|NCT00376623|FG000|Participant Flow|200 Milligram (mg) BI 2536 (Day 1)|A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799664|NCT00376623|FG001|Participant Flow|50 Milligram BI 2536 (Day 1 - Day 3)|A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799665|NCT00376623|FG002|Participant Flow|60 Milligram BI 2536 (Day 1 - Day 3)|After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
11196573|NCT02165605|FG000|Participant Flow|HA Serum Vs. Control Cream (Placebo)|Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the other breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within 4 hours prior to radiation treatment.
11196574|NCT02165605|OG000|Outcome|HylaCare|Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
11196575|NCT02165605|OG001|Outcome|Placebo|Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.
11241305|NCT02486302|OG000|Outcome|Etanercept|All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
11196576|NCT02165605|OG000|Outcome|HylaCare|"HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.~HylaCare: cream"
11384587|NCT03112590|FG001|Participant Flow|Phase 1 Level 2|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384588|NCT03112590|FG002|Participant Flow|Phase 2|"Interferon-gamma (IFN-γ): Phase 2: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384589|NCT03112590|OG000|Outcome|Combination Therapy|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 50 or 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Phase 2: IFN-γ at Recommended Phase II Dose (RP2D) subcutaneously (SQ) x 3 days/week, for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384590|NCT03112590|OG000|Outcome|Combination Therapy|"Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks.~Post Therapy Surgery: Phase 2: Participants will be assessed for surgery following the fourth cycle of study therapy (or earlier if study treatment is cancelled due to unmanageable side effects)."
11384591|NCT03112590|OG000|Outcome|Phase 2|"Interferon-gamma (IFN-γ): Phase 2: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384592|NCT03112590|EG000|Reported Event|Phase 1 Level 1|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 50 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384593|NCT03112590|EG001|Reported Event|Phase 1 Level 2|"Interferon-gamma (IFN-γ): Phase 1: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384594|NCT03112590|EG002|Reported Event|Phase 2|"Interferon-gamma (IFN-γ): Phase 2: IFN-γ 75 mcg/m^2 SQ x 3 days/week for 12 weeks.~Paclitaxel: Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.~Trastuzumab: Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.~Pertuzumab: Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks."
11384595|NCT03070444|BG000|Baseline|Group A: CTC Retainer + Essix Retainer|"The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384596|NCT03070444|BG001|Baseline|Group B: Essix Retainer + Essix Retainer|"The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384597|NCT03070444|BG002|Baseline|Total|Total of all reporting groups
10803462|NCT04046939|OG002|Outcome|75 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
11196577|NCT02165605|OG001|Outcome|Placebo|"The patient is her own control.~Placebo: placebo"
11196578|NCT02165605|EG000|Reported Event|Expected Adverse Events With and Without Skin Cream(Hylacare)|"Expected adverse event due to radiation with and without the skin cream (Hylacare).~Erythema~Pain~Tenderness~Irritability~Burning"
11384598|NCT03070444|FG000|Participant Flow|Group A: CTC Retainer + Essix Retainer|"The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384599|NCT03070444|FG001|Participant Flow|Group B: Essix Retainer + Essix Retainer|"The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384600|NCT03070444|OG000|Outcome|Group A: CTC Retainer + Essix Retainer|"The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384601|NCT03070444|OG001|Outcome|Group B: Essix Retainer + Essix Retainer|"The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384602|NCT03070444|EG000|Reported Event|Group A: CTC Retainer + Essix Retainer|"The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384603|NCT03070444|EG001|Reported Event|Group B: Essix Retainer + Essix Retainer|"The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.~Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.~Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.~Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.~Questionnaire: A questionnaire is completed at the follow-up visits."
11384604|NCT02952534|BG000|Baseline|BRCA Mutation|Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
11384605|NCT02952534|BG001|Baseline|ATM Mutation|Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
11384606|NCT02952534|BG002|Baseline|CDK12 Mutation|Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
11384607|NCT02952534|BG003|Baseline|CHEK2 Mutation|Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
11384608|NCT02952534|BG004|Baseline|Other Gene Mutation|Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
11384609|NCT02952534|BG005|Baseline|Total|Total of all reporting groups
11384610|NCT02952534|FG000|Participant Flow|BRCA Mutation|Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
10799666|NCT00376623|OG000|Outcome|200 Milligram (mg) BI 2536 (Day 1)|A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799667|NCT00376623|OG001|Outcome|50 Milligram BI 2536 (Day 1 - Day 3)|A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799668|NCT00376623|OG002|Outcome|60 Milligram BI 2536 (Day 1 - Day 3)|After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799669|NCT00376623|OG003|Outcome|"Combination of Treatment Group 50 mg BI 2536 (Day 1 - Day 3) and 60 mg BI 2536 (Day 1 - Day 3)"|A single dose of 50 mg or 60 mg (following implementation of protocol amendment 2) on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799670|NCT00376623|OG000|Outcome|200 Milligram BI 2536 (Day 1)|A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799671|NCT00376623|OG003|Outcome|Combination of 50 mg BI 2536 (Day 1 - Day 3) and 60 mg BI 2536 (Day 1 - Day 3)|A single dose of 50 mg or 60 mg (following implementation of protocol amendment 2) on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10803463|NCT04046939|OG003|Outcome|150 mg BID Dexpramipexole|"Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
10803464|NCT04046939|OG004|Outcome|Combined 150 mg BID and 75 mg BID Arms|"Following a 2-4 week placebo run-in, randomized subjects in this combined treatment group received 1 tablet of either 150 mg dexpramipexole twice daily for 12 weeks or 75 mg dexpramipexole trice daily for 12 weeks.~Dexpramipexole: dexpramipexole twice daily oral dosing for up to 12 weeks"
10799672|NCT00376623|OG000|Outcome|50 Milligram BI 2536 (Day 1 - Day 3)|A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799673|NCT00376623|OG001|Outcome|60 Milligram BI 2536 (Day 1 - Day 3)|After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799674|NCT00376623|EG000|Reported Event|200 Milligram (mg) BI 2536 (Day 1)|A single dose of 200 mg BI 2536 on day one of each treatment course (comprising 21 days including the day of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 50 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799675|NCT00376623|EG001|Reported Event|50 Milligram BI 2536 (Day 1 - Day 3)|A single dose of 50 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799676|NCT00376623|EG002|Reported Event|60 Milligram BI 2536 (Day 1 - Day 3)|After implementation of protocol amendment 2 a single dose of 60 mg BI 2536 on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10799677|NCT00376623|EG003|Reported Event|"Combination of Treatment Group 50 mg BI 2536 (Day 1 - Day 3) and 60 mg BI 2536 (Day 1 - Day 3)"|A single dose of 50 mg or 60 mg (following implementation of protocol amendment 2) on days 1, 2 and 3 of each treatment course (comprising 21 days including the days of administration) was administered as an intravenous infusion over a period of 60 minutes. Each participant was planned to receive at least 2 treatment courses, in case of clinical benefit (i.e., at least stable disease and acceptable tolerability) the participants could continue therapy with the trial drug. Trial drug administration was stopped temporarily in case of dose limiting toxicity (DLT). Participants could continue therapy only if recovery from DLT (to CTCAE levels which allowed further therapy) occurred and only with a dose reduced by up to 10 mg. Dose reduction was allowed only once for a participant during the whole trial. If a participant had experienced a second episode of DLT with the reduced dose or the participant had not recovered from DLT then the participant was withdrawn from the trial. A participant who continued therapy with BI 2536 beyond course 2 could be treated with a higher dose in case of non-progression and good tolerability.
10803465|NCT04046939|EG000|Reported Event|Screening Period|All subjects who signed informed consent and entered the Primary Assessment Period
11241306|NCT02486302|OG000|Outcome|Etanercept|All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799678|NCT00288080|BG000|Baseline|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
10799679|NCT00288080|BG001|Baseline|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
10799680|NCT00288080|BG002|Baseline|Total|Total of all reporting groups
10799681|NCT00288080|FG000|Participant Flow|Androgen Suppression + Radiation Therapy (RT)|Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
10799682|NCT00288080|FG001|Participant Flow|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
10799683|NCT00288080|OG000|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
10799684|NCT00288080|OG001|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
10799685|NCT00288080|EG000|Reported Event|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
10799686|NCT00288080|EG001|Reported Event|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
10799687|NCT00194714|BG000|Baseline|Treatment (HER-2/Neu Peptide Vaccine)|"Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.~HER-2/neu Peptide Vaccine: Given ID~Laboratory Biomarker Analysis: Correlative studies"
10799688|NCT00194714|FG000|Participant Flow|Treatment (HER-2/Neu Peptide Vaccine)|"Patients receive a HER-2/neu (HER2) specific cytotoxic T cell (CTL) generating peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. The final dose of peptide vaccine delivered is 1.5 mg (500 mcg/each peptide) admixed with 100 mcg GM-CSF as an adjuvant.~HER-2/neu Peptide Vaccine: Given ID~Laboratory Biomarker Analysis: Correlative studies"
10799689|NCT00194714|OG000|Outcome|Treatment (HER-2/Neu Peptide Vaccine)|"Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.~HER-2/neu Peptide Vaccine: Given ID~Laboratory Biomarker Analysis: Correlative studies"
10799690|NCT00194714|EG000|Reported Event|Treatment (HER-2/Neu Peptide Vaccine)|"Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.~HER-2/neu Peptide Vaccine: Given ID~Laboratory Biomarker Analysis: Correlative studies"
11196579|NCT02165722|BG000|Baseline|Intervention Sites|"Clinical practices: 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1.~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015)."
11196580|NCT02165722|BG001|Baseline|Control Sites|"Clinical practices: 11 Clinical Practices [control sites] were not actively intervened upon but continued their standard clinical practices regarding provision of vaccinations.~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015)."
11196581|NCT02165722|BG002|Baseline|Total|Total of all reporting groups
11241307|NCT02486302|OG000|Outcome|Etanercept|All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799691|NCT00099437|BG000|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
10799692|NCT00099437|BG001|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
10799693|NCT00099437|BG002|Baseline|Total|Total of all reporting groups
10799694|NCT00099437|FG000|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
10799695|NCT00099437|FG001|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
10799696|NCT00099437|OG000|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
10799697|NCT00099437|OG001|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
10799698|NCT00099437|EG000|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
10799699|NCT00099437|EG001|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
10803466|NCT04046939|EG001|Reported Event|Primary Assessment Period: Placebo BID|"Following the 2-4 week placebo Run-in Period, randomized subjects continued to receive 1 tablet placebo twice daily for 12 weeks during the Primary Assessment Period.~Placebo: 1 placebo tablet twice daily"
11196582|NCT02165722|FG000|Participant Flow|Intervention Sites|"9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1. Two practices dropped out of the intervention (11-2=9).~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~The 4 Pillars Toolkit is built around 4 pillars which include evidence-based strategies to increase vaccination rates:~Pillar 1: Convenient Vaccination Services~Pillar 2: Patient Notification~Pillar 3: Enhanced Office Systems~Pillar 4: Motivation"
11196583|NCT02165722|FG001|Participant Flow|Control Sites|"11 Clinical Practices [control sites] were not actively intervened upon.~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015)."
11196584|NCT02165722|OG000|Outcome|Intervention Group: HPV Series Initiation 11-13 Years of Age|"Practices: Represents 9 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11196585|NCT02165722|OG001|Outcome|Control Group: HPV Series Initiation 11-13 Years of Age|"Practices: Represents 11 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11196586|NCT02165722|OG002|Outcome|Intervention Group: HPV Series Initiation 14-17 Years of Age|"Practices: Represents 9 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11384611|NCT02952534|FG001|Participant Flow|ATM Mutation|Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
11384612|NCT02952534|FG002|Participant Flow|CDK12 Mutation|Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
11384613|NCT02952534|FG003|Participant Flow|CHEK2 Mutation|Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
11384614|NCT02952534|FG004|Participant Flow|Other Gene Mutation|Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
11384615|NCT02952534|OG000|Outcome|BRCA Mutation|Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
11384616|NCT02952534|OG001|Outcome|ATM Mutation|Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
11384617|NCT02952534|OG002|Outcome|CDK12 Mutation|Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
11241308|NCT02486302|OG000|Outcome|Etanercept|All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
11384618|NCT02952534|OG003|Outcome|CHEK2 Mutation|Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
11384619|NCT02952534|OG004|Outcome|Other Gene Mutation|Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
11384620|NCT02952534|OG001|Outcome|Other Gene Mutation|Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
11384621|NCT02952534|OG002|Outcome|CHEK2 Mutation|Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
11384622|NCT02952534|OG003|Outcome|Other Gene Mutation|Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
11384623|NCT02952534|EG000|Reported Event|All Patients|All patients received open-label oral rucaparib 600 mg BID (twice a day) in continuous 28-day cycles.
11384624|NCT02862548|BG000|Baseline|TAF 25 mg|"Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks~OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks"
11384625|NCT02862548|BG001|Baseline|TDF-Containing Regimens|"Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks~OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks"
11384626|NCT02862548|BG002|Baseline|Total|Total of all reporting groups
11384627|NCT02862548|FG000|Participant Flow|TAF 25 mg|"Randomized Phase: Tenofovir alafenamide (TAF) 25 mg tablet orally once daily for 48 weeks~Open-Label Extension (OLE) Phase: TAF 25 mg tablet orally once daily for additional 144 weeks"
11384628|NCT02862548|FG001|Participant Flow|TDF-Containing Regimens|"Randomized Phase: Tenofovir disoproxil fumarate (TDF) alone or in combination with other approved antivirals per local practice for 48 weeks~OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks"
11384629|NCT02862548|OG000|Outcome|TAF 25 mg|Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
11384630|NCT02862548|OG001|Outcome|TDF-Containing Regimens|Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
11384631|NCT02862548|EG000|Reported Event|Randomized Phase: TAF 25 mg|TAF 25 mg tablet orally once daily for 48 weeks
11384632|NCT02862548|EG001|Reported Event|Randomized Phase: TDF-Containing Regimens|TDF alone or in combination with other approved antivirals per local practice for 48 weeks
11384633|NCT02862548|EG002|Reported Event|OLE Phase: TAF 25 mg From TAF|Participants who received TAF 25 mg in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
11384634|NCT02862548|EG003|Reported Event|OLE Phase: TAF 25 mg From TDF|Participants who received TDF alone o in combination with approved antivirals per local practice in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
10799704|NCT02883673|BG000|Baseline|Jada Arm|Treatment Arm
10799705|NCT02883673|FG000|Participant Flow|Intervention|"Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.~Jada System: It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops."
10799706|NCT02883673|OG000|Outcome|ITT Population|Group where Jada treatment was applied
10799707|NCT02883673|OG000|Outcome|Intervention|"Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.~Jada System: It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops."
10799708|NCT02883673|EG000|Reported Event|ITT Population|Group where Jada treatment was applied
10799709|NCT02878785|BG000|Baseline|Phase 1: Decitabine and Talazoparib Combo|"Phase 1:~Decitabine by IV daily for 5 days every 28 days. Talazoparib orally daily days 1-28.~The 'outer layer' of this nested dose escalation trial will escalate the dose of the two drugs by sequentially going through dose levels 1-6 in the table found in the protocol. The standard algorithm of the 3+3 design will be applied.~Decitabine: DNA methyltransferase inhibitor~talazoparib: poly ADP ribose polymerase (PARP) inhibitor"
10799710|NCT02878785|FG000|Participant Flow|Cohort 1: Decitabine and Talazoparib Combo: Decitabine :10 mg/m^2: Period 1:|Participants were administered 10 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799711|NCT02878785|FG001|Participant Flow|Cohort 8: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2: Period 1a:|Participants were administered 10 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.50 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799712|NCT02878785|FG002|Participant Flow|Cohort 9: Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2;Period 2:|Participants were administered 15 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.25 mg of Talazopzrib orally diaily Days 1-28 at the same time each day
10799713|NCT02878785|FG003|Participant Flow|Cohort 10: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2;Period 1b:|Participants were administered 10 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.75 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799714|NCT02878785|FG004|Participant Flow|Cohort 11: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2;Period 1c:|Participants were administered 10 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799715|NCT02878785|FG005|Participant Flow|Cohort 12: Decitabine and Talazoparib Combo:Decitabine :15 mg/m^2;Period 2a|Participants were administered 15 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.50 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799716|NCT02878785|FG006|Participant Flow|Cohort 13: Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2;Period 2b:|Participants were administered 15 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.75 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799717|NCT02878785|FG007|Participant Flow|Cohort 14: Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2;Period 2c:|Participants were administered 15 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799718|NCT02878785|FG008|Participant Flow|Cohort 3: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 3:|Participants were administered 20 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799719|NCT02878785|FG009|Participant Flow|Cohort 4: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 4:|Participants were administered 20 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.50 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799720|NCT02878785|FG010|Participant Flow|Cohort 5: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 5:|Participants were administered 20 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.75 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799721|NCT02878785|FG011|Participant Flow|Cohort 6: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 6:|Participants were administered 20 mg/m^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799722|NCT02878785|FG012|Participant Flow|Cohort 7: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 7:|Participants were administered 20 mg/m^2 of Decitabine intravenously (IV) daily for 10 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
10799723|NCT02878785|FG013|Participant Flow|Cohort 2:Decitabine 15 mg/m2 x 5 Days|Participants were administered 15 mg/m2 x 5 days every 28 days. Participants were administered .25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
11384635|NCT02377089|BG000|Baseline|Sham|"The stimulators are the same device for the active and sham treatment conditions.~Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384636|NCT02377089|BG001|Baseline|Active|"The stimulators are the same device for the active and sham treatment conditions.~Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384637|NCT02377089|BG002|Baseline|Total|Total of all reporting groups
11384638|NCT02377089|FG000|Participant Flow|Sham|"The stimulators are the same device for the active and sham treatment conditions.~Placebo: Subjects will be randomized to treatment with either active or sham Trigeminal Nerve Stimulation (TNS) for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384639|NCT02377089|FG001|Participant Flow|Active|"The stimulators are the same device for the active and sham treatment conditions.~Trigeminal Nerve Stimulation (TNS): Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384640|NCT02377089|OG000|Outcome|Sham|"The stimulators are the same device for the active and sham treatment conditions.~Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=31 in sham group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384641|NCT02377089|OG001|Outcome|Active|"The stimulators are the same device for the active and sham treatment conditions.~Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=29 in active group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384642|NCT02377089|EG000|Reported Event|Sham|"The stimulators are the same device for the active and sham treatment conditions.~Placebo: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384643|NCT02377089|EG001|Reported Event|Active|"The stimulators are the same device for the active and sham treatment conditions.~Trigeminal Nerve Stimulation: Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work."
11384644|NCT02335099|BG000|Baseline|Treatment|90 mg of Ticagrelor to be given orally twice a day for 6 months
11384645|NCT02335099|BG001|Baseline|Placebo|Placebo drug to be given twice a day for 6 months
11384646|NCT02335099|BG002|Baseline|Total|Total of all reporting groups
11384647|NCT02335099|FG000|Participant Flow|Treatment|90 mg of Ticagrelor to be given orally twice a day for 6 months
11384648|NCT02335099|FG001|Participant Flow|Placebo|Placebo drug to be given twice a day for 6 months
11384649|NCT02335099|OG000|Outcome|Treatment|90 mg of Ticagrelor to be given orally twice a day for 6 months
11384650|NCT02335099|OG001|Outcome|Placebo|Placebo drug to be given twice a day for 6 months
11384651|NCT02335099|EG000|Reported Event|Treatment|90 mg of Ticagrelor to be given orally twice a day for 6 months
11384652|NCT02335099|EG001|Reported Event|Placebo|Placebo drug to be given twice a day for 6 months
11384653|NCT02330562|BG000|Baseline|Part 1 Cohort 1|Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384654|NCT02330562|BG001|Baseline|Part 1 Cohort 2|Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384655|NCT02330562|BG002|Baseline|Part 1 MTD + Dose Expansion Cohort|"Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.~MTD = Maximum Tolerated Dose"
11384656|NCT02330562|BG003|Baseline|Part 2 Cohort|Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
11384657|NCT02330562|BG004|Baseline|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384658|NCT02330562|BG005|Baseline|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
10799724|NCT02878785|OG000|Outcome|Cohort 1|Decitabine 10 mg/m^2 x 5 days Talazoparib 0.25 mg
11384659|NCT02330562|BG006|Baseline|Part 4 Cohort 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384660|NCT02330562|BG007|Baseline|Part 4 Cohort 2|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
10799725|NCT02878785|OG001|Outcome|Cohort 2|Decitabine 15 mg/m^2 x 5 days Talazoparib 0.25 mg
10799726|NCT02878785|OG002|Outcome|Cohort 3|Decitabine 20 mg/m^2 x 5 days Talazoparib 0.25 mg
10799727|NCT02878785|OG003|Outcome|Cohort 4|Decitabine 20 mg/m^2 x 5 days Talazoparib 0.50 mg
10799728|NCT02878785|OG004|Outcome|Cohort 5|Decitabine 20 mg/m^2 x 5 days Talazoparib 0.75 mg
10799729|NCT02878785|OG005|Outcome|Cohort 6|Decitabine 20 mg/m^2 x 5 days Talazoparib 1.0 mg
10799730|NCT02878785|OG006|Outcome|Cohort 7|Decitabine 20 mg/m^2 x 10 days Talazoparib 1.0 mg
10799731|NCT02878785|OG007|Outcome|Cohort 8|Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2
10799732|NCT02878785|OG008|Outcome|Cohort 9|Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2
10799733|NCT02878785|OG009|Outcome|Cohort 10|Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2
10799734|NCT02878785|OG010|Outcome|Cohort 11|Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2
10799735|NCT02878785|OG011|Outcome|Cohort 12|Decitabine and Talazoparib Combo:Decitabine :15 mg/m^2
10799736|NCT02878785|OG012|Outcome|Cohort 13|Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2
10799737|NCT02878785|OG013|Outcome|Cohort 14|Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2
10799738|NCT02878785|EG000|Reported Event|Phase 1 Dose Escalation|Decitabine in combination with Talazoparib
10803467|NCT04046939|EG002|Reported Event|Primary Assessment Period: 37.5 mg BID|"Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 37.5 mg twice daily for 12 weeks during the Primary Assessment Period.~Dexpramipexole: 1 dexpramipexole tablet twice daily"
10803468|NCT04046939|EG003|Reported Event|Primary Assessment Period: 75 mg BID|"Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 75 mg twice daily for 12 weeks during the Primary Assessment Period.~Dexpramipexole: 1 dexpramipexole tablet twice daily"
10803469|NCT04046939|EG004|Reported Event|Primary Assessment Period: 150 mg BID|"Following the 2-4 week placebo Run-in Period, randomized subjects received 1 tablet dexpramipexole 150 mg twice daily for 12 weeks during the Primary Assessment Period.~Dexpramipexole: 1 dexpramipexole tablet twice daily"
10803470|NCT04046939|EG005|Reported Event|Eosinophil Recovery Period: Assigned to Placebo BID During Primary Assessment Period|Following the Primary Assessment Period, subjects were followed within their randomized treatment group
10803471|NCT04046939|EG006|Reported Event|Eosinophil Recovery Period: Assigned to 37.5 mg BID During Primary Assessment Period|Following the Primary Assessment Period, subjects were followed within their randomized treatment group
10803472|NCT04046939|EG007|Reported Event|Eosinophil Recovery Period: Assigned to 75 mg BID During Primary Assessment Period|Following the Primary Assessment Period, subjects were followed within their randomized treatment group
10803473|NCT04046939|EG008|Reported Event|Eosinophil Recovery Period: Assigned to 150 mg BID During Primary Assessment Period|Following the Primary Assessment Period, subjects were followed within their randomized treatment group
10803474|NCT03912259|BG000|Baseline|Placebo Q2W|Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg Q2W for 16 weeks.
10803475|NCT03912259|BG001|Baseline|Dupilumab 300 mg Q2W|Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
10803476|NCT03912259|BG002|Baseline|Total|Total of all reporting groups
10803477|NCT03912259|FG000|Participant Flow|Placebo Q2W|Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.
10803478|NCT03912259|FG001|Participant Flow|Dupilumab 300 mg Q2W|Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
10803479|NCT03912259|OG000|Outcome|Placebo Q2W|Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.
10803480|NCT03912259|OG001|Outcome|Dupilumab 300 mg Q2W|Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
10803481|NCT03912259|OG000|Outcome|Placebo Q2W|Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg Q2W for 16 weeks.
10803482|NCT03912259|EG000|Reported Event|Placebo Q2W|Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.
10803483|NCT03912259|EG001|Reported Event|Dupilumab 300 mg Q2W|Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
10803484|NCT03890367|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10803485|NCT03890367|BG001|Baseline|Group 2: Nimenrix® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10803486|NCT03890367|BG002|Baseline|Group 3: NeisVac-C® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
10803487|NCT03890367|BG003|Baseline|Total|Total of all reporting groups
10803488|NCT03890367|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10803489|NCT03890367|FG001|Participant Flow|Group 2: Nimenrix® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10803490|NCT03890367|FG002|Participant Flow|Group 3: NeisVac-C® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
10803491|NCT03890367|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10803492|NCT03890367|OG001|Outcome|Group 2: Nimenrix® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10803493|NCT03890367|OG001|Outcome|Group 3: NeisVac-C® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
10803494|NCT03890367|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
10803495|NCT03890367|EG001|Reported Event|Group 2: Nimenrix® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
10803496|NCT03890367|EG002|Reported Event|Group 3: NeisVac-C® Vaccine|Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
10799739|NCT04794270|BG000|Baseline|Dispensed Subject|All subjects dispensed a study article.
11384661|NCT02330562|BG008|Baseline|Part 4 Cohort 3|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384662|NCT02330562|BG009|Baseline|Part 4 Cohort 4|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384663|NCT02330562|BG010|Baseline|Part 4 Cohort 5|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384664|NCT02330562|BG011|Baseline|Total|Total of all reporting groups
11384665|NCT02330562|FG000|Participant Flow|Part 1 Cohort 1|Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384666|NCT02330562|FG001|Participant Flow|Part 1 Cohort 2|Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384667|NCT02330562|FG002|Participant Flow|Part 1 MTD + Dose Expansion Cohort|"Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.~MTD = Maximum Tolerated Dose"
11384668|NCT02330562|FG003|Participant Flow|Part 2 Cohort|Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
11384669|NCT02330562|FG004|Participant Flow|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384670|NCT02330562|FG005|Participant Flow|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
11384671|NCT02330562|FG006|Participant Flow|Part 4 Cohort 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384672|NCT02330562|FG007|Participant Flow|Part 4 Cohort 2|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384673|NCT02330562|FG008|Participant Flow|Part 4 Cohort 3|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384674|NCT02330562|FG009|Participant Flow|Part 4 Cohort 4|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384675|NCT02330562|FG010|Participant Flow|Part 4 Cohort 5|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384676|NCT02330562|OG000|Outcome|Part 2 Cohort|Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
11384677|NCT02330562|OG000|Outcome|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384678|NCT02330562|OG001|Outcome|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
11384679|NCT02330562|OG000|Outcome|Part 1 Cohort 1|Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384680|NCT02330562|OG001|Outcome|Part 1 Cohort 2|Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384681|NCT02330562|OG002|Outcome|Part 1 MTD + Dose Expansion Cohort|"Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.~MTD = Maximum Tolerated Dose"
11384682|NCT02330562|OG003|Outcome|Part 2 Cohort|Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
11384683|NCT02330562|OG004|Outcome|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384684|NCT02330562|OG005|Outcome|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
11384685|NCT02330562|OG006|Outcome|Part 4 Cohort 1 - Cycle 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384686|NCT02330562|OG007|Outcome|Part 4 Cohort 2 - Cycle 1|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384687|NCT02330562|OG008|Outcome|Part 4 Cohort 3 - Cycle 1|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384688|NCT02330562|OG009|Outcome|Part 4 Cohort 4 - Cycle 1|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384689|NCT02330562|OG010|Outcome|Part 4 Cohort 5 - Cycle 1|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384690|NCT02330562|OG011|Outcome|Part 4 All Cohorts - Cycles 2 and Subsequent|Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384691|NCT02330562|OG003|Outcome|Part 4 Cohort 1 - Cycle 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
10799740|NCT04794270|FG000|Participant Flow|Control/Test|Subjects that wore the Control lens in a bilateral fashion during Period 1 and the Test lens during Period 2.
11384692|NCT02330562|OG004|Outcome|Part 4 Cohort 2 - Cycle 1|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384693|NCT02330562|OG005|Outcome|Part 4 Cohort 3 - Cycle 1|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384694|NCT02330562|OG006|Outcome|Part 4 Cohort 4 - Cycle 1|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384695|NCT02330562|OG007|Outcome|Part 4 Cohort 5 - Cycle 1|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
11384696|NCT02330562|OG003|Outcome|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384697|NCT02330562|OG004|Outcome|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
11384698|NCT02330562|OG006|Outcome|Part 4 Cohort 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384699|NCT02330562|OG007|Outcome|Part 4 Cohort 2|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
10799741|NCT04794270|FG001|Participant Flow|Test/Control|Subjects that wore the Test lens in a bilateral fashion during Period 1 and the Control lens during Period 2.
11384700|NCT02330562|OG008|Outcome|Part 4 Cohort 3|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384701|NCT02330562|OG009|Outcome|Part 4 Cohort 4|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384702|NCT02330562|OG010|Outcome|Part 4 Cohort 5|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384703|NCT02330562|OG004|Outcome|Part 4 Cohort 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384704|NCT02330562|OG005|Outcome|Part 4 Cohort 2|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384705|NCT02330562|OG006|Outcome|Part 4 Cohort 3|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384706|NCT02330562|OG007|Outcome|Part 4 Cohort 4|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384707|NCT02330562|OG008|Outcome|Part 4 Cohort 5|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384708|NCT02330562|EG000|Reported Event|Part 1 Cohort 1|Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384709|NCT02330562|EG001|Reported Event|Part 1 Cohort 2|Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
11384710|NCT02330562|EG002|Reported Event|Part 1 MTD + Dose Expansion Cohort|"Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.~MTD = Maximum Tolerated Dose"
11384711|NCT02330562|EG003|Reported Event|Part 2 Cohort|Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
11384712|NCT02330562|EG004|Reported Event|Part 3 Cohort 1|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
11384713|NCT02330562|EG005|Reported Event|Part 3 Cohort 2|Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
11384714|NCT02330562|EG006|Reported Event|Part 4 Cohort 1|Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384715|NCT02330562|EG007|Reported Event|Part 4 Cohort 2|Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384716|NCT02330562|EG008|Reported Event|Part 4 Cohort 3|Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384717|NCT02330562|EG009|Reported Event|Part 4 Cohort 4|Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
10799742|NCT04794270|OG000|Outcome|Test|All subjects that wore the Test lens during any of the 2 wear periods.
10799743|NCT04794270|OG001|Outcome|Control|All subjects that wore the Control lens during any of the 2 wear periods.
10799744|NCT04794270|EG000|Reported Event|Test|All subjects that wore the Test lens during any of the 2 wear periods.
10799745|NCT04794270|EG001|Reported Event|Control|All subjects that wore the Control lens during any of the 2 wear periods.
10803497|NCT03784898|BG000|Baseline|Participants Diagnosed With ITP|Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
10803498|NCT03784898|FG000|Participant Flow|Participants Diagnosed With ITP|Participants with Relapsing Forms of Multiple Sclerosis (RMS) who developed Immune thrombocytopenic purpura (ITP) after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
10803499|NCT03784898|OG000|Outcome|Participants Diagnosed With ITP|Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
10803500|NCT03784898|EG000|Reported Event|Participants Diagnosed With ITP|Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
10803913|NCT01146652|EG001|Reported Event|Sarilumab Monotherapy|Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks).
10803914|NCT01049035|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
10803915|NCT01049035|BG001|Baseline|Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
10803916|NCT01049035|BG002|Baseline|Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
10803917|NCT01049035|BG003|Baseline|Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months|Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
10803918|NCT01049035|BG004|Baseline|Group 5: MenACYW Conjugate Vaccine: 12 Months|Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
10803919|NCT01049035|BG005|Baseline|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
10803920|NCT01049035|BG006|Baseline|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
10803921|NCT01049035|BG007|Baseline|Total|Total of all reporting groups
10803922|NCT01049035|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
10803923|NCT01049035|FG001|Participant Flow|Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
10803924|NCT01049035|FG002|Participant Flow|Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
10803925|NCT01049035|FG003|Participant Flow|Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months|Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
10799746|NCT04701814|BG000|Baseline|Group A (Controlled Group)|received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.
10799747|NCT04701814|BG001|Baseline|Group B(Study Group)|"All patients in group B received same treatment as group A with biomechanical scapular mobilization with movement and motor learning.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799748|NCT04701814|BG002|Baseline|Total|Total of all reporting groups
10799749|NCT04701814|FG000|Participant Flow|Group A (Controlled Group)|received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.
10799750|NCT04701814|FG001|Participant Flow|Group B(Study Group)|"All patients in group B received same treatment as group A with adding biomechanical scapular mobilization with movement and motor learning.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799751|NCT04701814|OG000|Outcome|Group A (Controlled Group)|received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.
10799752|NCT04701814|OG001|Outcome|Group B(Study Group)|"All patients in group B received same treatment as group A but adding biomechanical scapular mobilization with movement and motor learning to treatment.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799753|NCT04701814|OG000|Outcome|Group A (Controlled Group)|"received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799754|NCT04701814|OG001|Outcome|Group B(Study Group)|"All patients in group B received biomechanical scapular mobilization with movement and motor learning and traditional methods.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799755|NCT04701814|EG000|Reported Event|Group A (Controlled Group)|received passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM) exercises, strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). This treatment was repeated three times per weeks with 24 hours rest for 3 weeks.
10799756|NCT04701814|EG001|Reported Event|Group B(Study Group)|"All patients in group B received same treatment as group A but adding biomechanical scapular mobilization with movement and motor learning to treatment.~biomechanical scapular mobilization with movement and motor learning: the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula."
10799757|NCT04650282|BG000|Baseline|Lidocaine in SphenoCath Device|"One treatment was given.~Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10803501|NCT03607422|BG000|Baseline|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day for 16 weeks.
11196587|NCT02165722|OG003|Outcome|Control Group: HPV Series Initiation 14-17 Years of Age|"Practices: Represents 11 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11196588|NCT02165722|OG000|Outcome|Intervention Group: HPV Series Completion 11-13 Years of Age|"Practices: Represents 9 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11241309|NCT02486302|OG000|Outcome|Etanercept|All participants with RA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799758|NCT04650282|BG001|Baseline|Saline Solution in SphenoCath Device|"One treatment was given.~Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799759|NCT04650282|BG002|Baseline|Total|Total of all reporting groups
10799760|NCT04650282|FG000|Participant Flow|Lidocaine in SphenoCath Device|"One treatment was given.~Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799761|NCT04650282|FG001|Participant Flow|Saline Solution in SphenoCath Device|"One treatment was given.~Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799762|NCT04650282|OG000|Outcome|Lidocaine in SphenoCath Device|"One treatment was given.~Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799763|NCT04650282|OG001|Outcome|Saline Solution in SphenoCath Device|"One treatment was given.~Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799764|NCT04650282|EG000|Reported Event|Lidocaine in SphenoCath Device|"One treatment was given.~Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10799765|NCT04650282|EG001|Reported Event|Saline Solution in SphenoCath Device|"One treatment was given.~Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds."
10803502|NCT03607422|BG001|Baseline|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.
10803503|NCT03607422|BG002|Baseline|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.
10803504|NCT03607422|BG003|Baseline|Adolescents: Placebo|Adolescent participants received placebo orally once a day for 16 weeks.
11196589|NCT02165722|OG001|Outcome|Control Group: HPV Series Completion 11-13 Years of Age|"Practices: Represents 11 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11196590|NCT02165722|OG002|Outcome|Intervention Group: HPV Series Completion 14-17 Years of Age|"Practices: Represents 9 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
11196591|NCT02165722|OG003|Outcome|Control Group: HPV Series Completion 14-17 Years of Age|"Practices: Represents 11 clinical practices~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015).~Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015."
10803505|NCT03607422|BG004|Baseline|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
10803506|NCT03607422|BG005|Baseline|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
10803507|NCT03607422|BG006|Baseline|Total|Total of all reporting groups
10803508|NCT03607422|FG000|Participant Flow|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day (QD) for 16 weeks.
10803509|NCT03607422|FG001|Participant Flow|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.
10803510|NCT03607422|FG002|Participant Flow|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.
10803511|NCT03607422|FG003|Participant Flow|Adolescents: Placebo|Adolescent participants (12 - 17 years old) received placebo orally once a day for 16 weeks.
10803512|NCT03607422|FG004|Participant Flow|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
10803513|NCT03607422|FG005|Participant Flow|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
10803514|NCT03607422|OG000|Outcome|Placebo|Participants received placebo orally once a day for 16 weeks.
10803515|NCT03607422|OG001|Outcome|Upadacitinib 15 mg QD|Participants received upadacitinib 15 mg orally once a day for 16 weeks.
10803516|NCT03607422|OG002|Outcome|Upadacitinib 30 mg QD|Participants received upadacitinib 30 mg orally once a day for 16 weeks.
10803517|NCT03607422|OG000|Outcome|Adolescents: Placebo|Adolescent participants received placebo orally once a day for 16 weeks.
10803518|NCT03607422|OG001|Outcome|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
10803519|NCT03607422|OG002|Outcome|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
10803520|NCT03607422|EG000|Reported Event|Adults: Placebo|Participants ≥ 18 years old received placebo orally once a day for 16 weeks.
10803521|NCT03607422|EG001|Reported Event|Adults: Upadacitinib 15 mg QD|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.
10803522|NCT03607422|EG002|Reported Event|Adults: Upadacitinib 30 mg QD|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.
10803523|NCT03607422|EG003|Reported Event|Adolescents: Placebo|Adolescent participants received placebo orally once a day for 16 weeks.
10803524|NCT03607422|EG004|Reported Event|Adolescents: Upadacitinib 15 mg QD|Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.
10803525|NCT03607422|EG005|Reported Event|Adolescents: Upadacitinib 30 mg QD|Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.
11384718|NCT02330562|EG010|Reported Event|Part 4 Cohort 5|Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
11384719|NCT02053363|BG000|Baseline|High Dose/Study Group|"Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384720|NCT02053363|BG001|Baseline|Standard of Care/Control|"Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384721|NCT02053363|BG002|Baseline|Total|Total of all reporting groups
11384722|NCT02053363|FG000|Participant Flow|High Dose/Study Group|"Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11196592|NCT02165722|EG000|Reported Event|Intervention Sites|"Clinical practices: 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1.~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015)."
11384723|NCT02053363|FG001|Participant Flow|Standard of Care/Control|"Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384724|NCT02053363|OG000|Outcome|High Dose/Study Group|"Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384725|NCT02053363|OG001|Outcome|Standard of Care/Control|"Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384726|NCT02053363|EG000|Reported Event|High Dose/Study Group|"Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
10799775|NCT04394286|BG000|Baseline|Cohort 1: SHP648|Cohort 1 participants were planned to receive a single IV infusion of SHP648 at dose 4.0*10^11 vg/kg BW on the day of dosing (Day 0).
11384727|NCT02053363|EG001|Reported Event|Standard of Care/Control|"Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.~Tranexamic Acid (Cyklokapron)"
11384728|NCT02035137|BG000|Baseline|Single-Agent 131I-MIBG|"Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG"
11384729|NCT02035137|BG001|Baseline|131I-MIBG With Vincristine/Irinotecan|"Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vincristine~Irinotecan"
11384730|NCT02035137|BG002|Baseline|131I-MIBG With Vorinostat|"Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vorinostat"
11384731|NCT02035137|BG003|Baseline|Total|Total of all reporting groups
11384732|NCT02035137|FG000|Participant Flow|Single-Agent 131I-MIBG|"Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG"
11384733|NCT02035137|FG001|Participant Flow|131I-MIBG With Vincristine/Irinotecan|"Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vincristine~Irinotecan"
11384734|NCT02035137|FG002|Participant Flow|131I-MIBG With Vorinostat|"Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vorinostat"
11384735|NCT02035137|OG000|Outcome|Single-Agent 131I-MIBG|"Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG"
11384736|NCT02035137|OG001|Outcome|131I-MIBG With Vincristine/Irinotecan|"Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vincristine~Irinotecan"
11384737|NCT02035137|OG002|Outcome|131I-MIBG With Vorinostat|"Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vorinostat"
11384738|NCT02035137|EG000|Reported Event|Single-Agent 131I-MIBG|"Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG"
11384739|NCT02035137|EG001|Reported Event|131I-MIBG With Vincristine/Irinotecan|"Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vincristine~Irinotecan"
11384740|NCT02035137|EG002|Reported Event|131I-MIBG With Vorinostat|"Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.~131I-MIBG~Vorinostat"
11384741|NCT01975571|BG000|Baseline|Adult|"Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384742|NCT01975571|BG001|Baseline|Children and Adolescents (L24)|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
10799776|NCT04394286|BG001|Baseline|Cohort 2: SHP648|Cohort 2 participants were planned to receive a single IV infusion of SHP648 at dose 8.0*10^11 vg/kg BW or 1.2*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 2 was to be decided upon evaluation of Cohort 1 data and recommendation from an external Data Monitoring Committee.
10799777|NCT04394286|BG002|Baseline|Cohort 3: SHP648|Cohort 3 participants were planned to receive a single IV infusion of SHP648 at dose 1.6*10^12 vg/kg BW or 2.4*10^12 vg/kg BW or 3.6*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 3 was to be decided upon evaluation of Cohort 2 data and recommendation from an external Data Monitoring Committee.
11384743|NCT01975571|BG002|Baseline|Children and Adolescents S12|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid S12 cochlear implant.~Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy."
11384744|NCT01975571|BG003|Baseline|Total|Total of all reporting groups
11384745|NCT01975571|FG000|Participant Flow|Adult|"Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384746|NCT01975571|FG001|Participant Flow|Children and Adolescents (L24)|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384747|NCT01975571|FG002|Participant Flow|Children and Adolescents S12|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid S12 cochlear implant.~Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy."
11384748|NCT01975571|OG000|Outcome|Adult|"Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384749|NCT01975571|OG001|Outcome|Children and Adolescents (L24)|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
10799778|NCT04394286|BG003|Baseline|Total|Total of all reporting groups
10799779|NCT04394286|FG000|Participant Flow|Cohort 1: SHP648|Cohort 1 participants were planned to receive a single intravenous (IV) infusion of SHP648 at dose 4.0*10^11 vector genome (vg) per kilogram (kg) body weight (BW) on the day of dosing (Day 0).
10799780|NCT04394286|FG001|Participant Flow|Cohort 2: SHP648|Cohort 2 participants were planned to receive a single IV infusion of SHP648 at dose 8.0*10^11 vg/kg BW or 1.2*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 2 was to be decided upon evaluation of Cohort 1 data and recommendation from an external Data Monitoring Committee.
10799781|NCT04394286|FG002|Participant Flow|Cohort 3: SHP648|Cohort 3 participants were planned to receive a single IV infusion of SHP648 at dose 1.6*10^12 vg/kg BW or 2.4*10^12 vg/kg BW or 3.6*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 3 was to be decided upon evaluation of Cohort 2 data and recommendation from an external Data Monitoring Committee.
10799782|NCT04394286|OG000|Outcome|Cohort 1: SHP648|Cohort 1 participants were planned to receive a single IV infusion of SHP648 at dose 4.0*10^11 vg/kg BW on the day of dosing (Day 0).
10799783|NCT04394286|OG001|Outcome|Cohort 2: SHP648|Cohort 2 participants were planned to receive a single IV infusion of SHP648 at dose 8.0*10^11 vg/kg BW or 1.2*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 2 was to be decided upon evaluation of Cohort 1 data and recommendation from an external Data Monitoring Committee.
10799784|NCT04394286|OG002|Outcome|Cohort 3: SHP648|Cohort 3 participants were planned to receive a single IV infusion of SHP648 at dose 1.6*10^12 vg/kg BW or 2.4*10^12 vg/kg BW or 3.6*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 3 was to be decided upon evaluation of Cohort 2 data and recommendation from an external Data Monitoring Committee.
10799785|NCT04394286|EG000|Reported Event|Cohort 1: SHP648|Cohort 1 participants were planned to receive a single IV infusion of SHP648 at dose 4.0*10^11 vg/kg BW on the day of dosing (Day 0).
10799786|NCT04394286|EG001|Reported Event|Cohort 2: SHP648|Cohort 2 participants were planned to receive a single IV infusion of SHP648 at dose 8.0*10^11 vg/kg BW or 1.2*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 2 was to be decided upon evaluation of Cohort 1 data and recommendation from an external Data Monitoring Committee.
10799787|NCT04394286|EG002|Reported Event|Cohort 3: SHP648|Cohort 3 participants were planned to receive a single IV infusion of SHP648 at dose 1.6*10^12 vg/kg BW or 2.4*10^12 vg/kg BW or 3.6*10^12 vg/kg BW on the day of dosing (Day 0). The dosing of Cohort 3 was to be decided upon evaluation of Cohort 2 data and recommendation from an external Data Monitoring Committee.
10803526|NCT03600805|BG000|Baseline|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
10803527|NCT03600805|BG001|Baseline|Placebo+26 Week Taper|Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803528|NCT03600805|BG002|Baseline|Sarilumab 150mg q2w+26 Week Taper|Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803529|NCT03600805|BG003|Baseline|Sarilumab 200mg q2w+26 Week Taper|Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
11241310|NCT02486302|OG000|Outcome|Etanercept|All participants with RA, axSpA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10803530|NCT03600805|BG004|Baseline|Total Title|
10803531|NCT03600805|FG000|Participant Flow|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
10803532|NCT03600805|FG001|Participant Flow|Placebo+26 Week Taper|Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803533|NCT03600805|FG002|Participant Flow|Sarilumab 150mg q2w+26 Week Taper|Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803534|NCT03600805|FG003|Participant Flow|Sarilumab 200mg q2w+26 Week Taper|Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803535|NCT03600805|OG000|Outcome|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
10803536|NCT03600805|OG001|Outcome|Placebo+26 Week Taper|Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803537|NCT03600805|OG002|Outcome|Sarilumab 150mg q2w+26 Week Taper|Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10799788|NCT04327986|BG000|Baseline|Cohort 1 Phase 1A/Arm 1A Dose Level 0 De-Escalation|"De-escalating doses of NHS-IL12 (M9241) in combination with bintrafusp alfa (M7824)~M7824: Intravenous (IV) on Days 1 and 15 of every cycle~M9241: Subcutaneous injection on Day 1 of every cycle~M7824, 1200mg intravenous every 2 weeks; M9241, 16.8g/kg, subcutaneously, every 4 weeks"
10799789|NCT04327986|FG000|Participant Flow|Cohort 1 Phase 1A/Arm 1A Dose Level 0 De-Escalation|"De-escalating doses of NHS-IL12 (M9241) in combination with bintrafusp alfa (M7824)~M7824: Intravenous (IV) on Days 1 and 15 of every cycle~M9241: Subcutaneous injection on Day 1 of every cycle~M7824, 1200mg intravenous every 2 weeks; M9241, 16.8g/kg, subcutaneously, every 4 weeks"
10799790|NCT04327986|FG001|Participant Flow|Cohort 2 Phase 1B Arm 1B|No participants were enrolled on Cohort 2 Phase 1B Arm 1B. The study never progressed beyond stage 1A.
11196593|NCT02165722|EG001|Reported Event|Control Sites|"Clinical practices: 11 Clinical Practices [control sites] were not actively intervened upon but continued their standard clinical practices regarding provision of vaccinations.~Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015)."
11384750|NCT01975571|OG002|Outcome|Children and Adolescents S12|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid S12 cochlear implant.~Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy."
11384751|NCT01975571|EG000|Reported Event|Adult|"Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384752|NCT01975571|EG001|Reported Event|Children and Adolescents (L24)|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid L24 cochlear implant.~Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne."
11384753|NCT01975571|EG002|Reported Event|Children and Adolescents S12|"Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.~Intervention: These patients will receive a Hybrid S12 cochlear implant.~Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy."
10799791|NCT04327986|FG002|Participant Flow|Phase II Cohort 3 Arm 2|No participants were enrolled on Phase II Cohort 3 Arm 2. The study never progressed beyond stage 1A.
10799792|NCT04327986|OG000|Outcome|Cohort 1 Phase 1A/Arm 1A Dose Level 0 De-Escalation|"De-escalating doses of NHS-IL12 (M9241) in combination with bintrafusp alfa (M7824)~M7824: Intravenous (IV) on Days 1 and 15 of every cycle~M9241: Subcutaneous injection on Day 1 of every cycle~M7824, 1200mg intravenous every 2 weeks; M9241, 16.8g/kg, subcutaneously, every 4 weeks"
10799793|NCT04327986|EG000|Reported Event|Cohort 1 Phase 1A/Arm 1A Dose Level 0 De-Escalation|"De-escalating doses of NHS-IL12 (M9241) in combination with bintrafusp alfa (M7824)~M7824: Intravenous (IV) on Days 1 and 15 of every cycle~M9241: Subcutaneous injection on Day 1 of every cycle~M7824, 1200mg intravenous every 2 weeks; M9241, 16.8g/kg, subcutaneously, every 4 weeks"
10803538|NCT03600805|OG003|Outcome|Sarilumab 200mg q2w+26 Week Taper|Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803539|NCT03600805|OG000|Outcome|Sarilumab 150mg q2w+26 Week Taper|Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10799794|NCT04086121|BG000|Baseline|Spesolimab 600 mg|"600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks, up to 4 years (204 weeks) of End of Treatment (EOT).~All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit."
10799795|NCT04086121|FG000|Participant Flow|Spesolimab 600 mg|"600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks, up to 4 years (204 weeks) of End of Treatment (EOT).~All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit."
10799796|NCT04086121|OG000|Outcome|Spesolimab 600 mg|"600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks, up to 4 years (204 weeks) of End of Treatment (EOT).~All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit."
10799797|NCT04086121|EG000|Reported Event|Spesolimab 600 mg|"600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks, up to 4 years (204 weeks) of End of Treatment (EOT).~All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit."
10799798|NCT04067843|BG000|Baseline|Photodynamic Treatment|Skin microbiome analysis after photodynamic treatment before and after skin antisepsis
10799799|NCT04067843|BG001|Baseline|Control Group|No photodynamic treatment: Skin microbiome before and after skin antisepsis without photodynamic treatment
10799800|NCT04067843|BG002|Baseline|Total|Total of all reporting groups
10799801|NCT04067843|FG000|Participant Flow|Photodynamic Treatment|"Skin microbiome after photodynamic treatment before and after skin antisepsis~Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes"
10799802|NCT04067843|FG001|Participant Flow|Control Group|Skin microbiome before and after skin antisepsis, no photodynamic treatment
10799803|NCT04067843|OG000|Outcome|Photodynamic Treatment|"Skin swabs were taken before photodynamic treatment as baseline, after photodynamic treatment and after skin antisepsis to analyse the skin microbiome~Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes"
10799804|NCT04067843|OG001|Outcome|Control Group|Skin swabs were taken before and after skin antisepsis
10799805|NCT04067843|OG000|Outcome|Photodynamic Treatment|"Skin microbiome after photodynamic treatment before and after skin antisepsis~Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes"
10799806|NCT04067843|OG000|Outcome|Phylogenetic Comparisons of Isolated Bacteria|was not performed due to clear results in aim 1 and 2.
11241311|NCT02486302|OG000|Outcome|Etanercept|All participants with axSpA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
11241312|NCT02486302|OG000|Outcome|Etanercept|All participants with PsO, PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
10799807|NCT04067843|EG000|Reported Event|Photodynamic Treatment|Participants were treated with photodynamic treatment
10799808|NCT04067843|EG001|Reported Event|Control Group|Participants were not treated with photodynamic treatment
10799809|NCT04066738|BG000|Baseline|Patients With Myocardial Scar|"Patient with previous STEMI resulting in myocardial scar, elected to CRT implant~Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system~3D reconstruction and location of coronary sinus venous system relative to myocardial scar: Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar~Acute haemodynamic measurements during CRT implant: Advancement of pressure wire to LV cavity via femoral/radial arterial access.~Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)"
10799810|NCT04066738|FG000|Participant Flow|Patients With Myocardial Scar|"Patient with previous STEMI resulting in myocardial scar, elected to CRT implant~Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system~3D reconstruction and location of coronary sinus venous system relative to myocardial scar: Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar~Acute haemodynamic measurements during CRT implant: Advancement of pressure wire to LV cavity via femoral/radial arterial access.~Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)"
10799811|NCT04066738|OG000|Outcome|Patients With Myocardial Scar|"Patient with previous STEMI resulting in myocardial scar, elected to CRT implant~Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system~3D reconstruction and location of coronary sinus venous system relative to myocardial scar: Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar~Acute haemodynamic measurements during CRT implant: Advancement of pressure wire to LV cavity via femoral/radial arterial access.~Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)"
10803540|NCT03600805|OG001|Outcome|Sarilumab 200mg q2w+26 Week Taper|Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
11241313|NCT02486302|OG000|Outcome|Etanercept|All participants with RA, axSpA, or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
11241314|NCT02486302|EG000|Reported Event|Etanercept|All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
11196594|NCT02165735|BG000|Baseline|Patient Empowerment|"Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships.~Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.~Patient Empowerment and Autonomy Training"
11384754|NCT01660451|BG000|Baseline|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384755|NCT01660451|BG001|Baseline|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384756|NCT01660451|BG002|Baseline|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384757|NCT01660451|BG003|Baseline|Total|Total of all reporting groups
11384758|NCT01660451|FG000|Participant Flow|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384759|NCT01660451|FG001|Participant Flow|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384760|NCT01660451|FG002|Participant Flow|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384761|NCT01660451|OG000|Outcome|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384762|NCT01660451|OG001|Outcome|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384763|NCT01660451|OG000|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384764|NCT01660451|OG002|Outcome|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384765|NCT01660451|EG000|Reported Event|Part A: Indolent NHL/CLL|Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11384766|NCT01660451|EG001|Reported Event|Part A: Aggressive NHL|Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
10803541|NCT03600805|EG000|Reported Event|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
11196595|NCT02165735|BG001|Baseline|Standard Care|Participants will be followed through usual source of care, without receiving the empowerment training.
11196596|NCT02165735|BG002|Baseline|Total|Total of all reporting groups
11196597|NCT02165735|FG000|Participant Flow|Patient Empowerment|"Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships.~Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.~Patient Empowerment and Autonomy Training"
11196598|NCT02165735|FG001|Participant Flow|Standard Care|Participants will be followed through usual source of care, without receiving the empowerment training.
11196599|NCT02165735|OG000|Outcome|Patient Empowerment|"Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships.~Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships."
11196600|NCT02165735|OG001|Outcome|Standard Care|Participants will be followed through usual source of care, without receiving the empowerment training.
11196601|NCT02165735|EG000|Reported Event|Patient Empowerment|"Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships.~Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.~Patient Empowerment and Autonomy Training"
11196602|NCT02165735|EG001|Reported Event|Standard Care|Participants will be followed through usual source of care, without receiving the empowerment training.
11196603|NCT02165761|BG000|Baseline|GORE® Hybrid Vascular Graft|"GORE® Hybrid Vascular Graft>~> GORE® Hybrid Vascular Graft"
11196604|NCT02165761|BG001|Baseline|Non-heparin Bonded Synthetic Graft|"Non-heparin bonded synthetic graft>~> Non-heparin bonded synthetic graft"
11196605|NCT02165761|BG002|Baseline|Total|Total of all reporting groups
11196606|NCT02165761|FG000|Participant Flow|GORE® Hybrid Vascular Graft|Subjects Randomized to the GORE® Hybrid Vascular Graft
11196607|NCT02165761|FG001|Participant Flow|Non-heparin Bonded Synthetic Graft|Subjects Randomized to the Non-heparin bonded synthetic graft
11196608|NCT02165761|OG000|Outcome|GORE® Hybrid Vascular Graft|"GORE® Hybrid Vascular Graft >~> GORE® Hybrid Vascular Graft"
11196609|NCT02165761|OG001|Outcome|Non-heparin Bonded Synthetic Graft|"Non-heparin bonded synthetic graft >~> Non-heparin bonded synthetic graft"
11196610|NCT02165761|EG000|Reported Event|Hybrid Vascular Graft (Test)|Hybrid Vascular Graft (Test)
11196611|NCT02165761|EG001|Reported Event|Non-Heparin Synthetic Graft (Control)|Non-Heparin Synthetic Graft (Control)
11196612|NCT02165826|BG000|Baseline|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196613|NCT02165826|BG001|Baseline|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196614|NCT02165826|BG002|Baseline|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
11196615|NCT02165826|BG003|Baseline|Total|Total of all reporting groups
11196616|NCT02165826|FG000|Participant Flow|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196617|NCT02165826|FG001|Participant Flow|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196618|NCT02165826|FG002|Participant Flow|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
11196619|NCT02165826|OG000|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196620|NCT02165826|OG001|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196621|NCT02165826|OG002|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
11196622|NCT02165826|OG000|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11241315|NCT02486328|BG000|Baseline|Group MM|"2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3~Midazolam: Dosage adjustment~Meperidine: Dosage adjustment"
11241316|NCT02486328|BG001|Baseline|Group RP|"100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3~Remifentanil: Dosage adjustment~Propofol: Dosage adjustment"
11241317|NCT02486328|BG002|Baseline|Total|Total of all reporting groups
11241318|NCT02486328|FG000|Participant Flow|Group MM|"2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when facial pain scale (FPS) greater than 3~Midazolam: Dosage adjustment~Meperidine: Dosage adjustment"
11241319|NCT02486328|FG001|Participant Flow|Group RP|"100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3~Remifentanil: Dosage adjustment~Propofol: Dosage adjustment"
11241320|NCT02486328|OG000|Outcome|Group MM|"2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3~Midazolam: Dosage adjustment~Meperidine: Dosage adjustment"
11241321|NCT02486328|OG001|Outcome|Group RP|"100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3~Remifentanil: Dosage adjustment~Propofol: Dosage adjustment"
11241322|NCT02486328|EG000|Reported Event|Group MM|"2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3~Midazolam: Dosage adjustment~Meperidine: Dosage adjustment"
11241323|NCT02486328|EG001|Reported Event|Group RP|"100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3~Remifentanil: Dosage adjustment~Propofol: Dosage adjustment"
11384767|NCT01660451|EG002|Reported Event|Part B: Indolent NHL|Participants with indolent B-cell NHL received copanlisib 60 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
11241324|NCT02486406|BG000|Baseline|Adult Tablet, 12-17 yr, Part 1|Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
11241325|NCT02486406|BG001|Baseline|Adult Tablet, 12-17 yr, Part 2|Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
11241326|NCT02486406|BG002|Baseline|Mini Tablet, 9-11 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
11241327|NCT02486406|BG003|Baseline|Mini Tablet, 3-8 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
11241328|NCT02486406|BG004|Baseline|Total|Total of all reporting groups
11241329|NCT02486406|FG000|Participant Flow|Adult Tablet, 12-17 yr, Part 1|Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
11241330|NCT02486406|FG001|Participant Flow|Adult Tablet, 12-17 yr, Part 2|Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
11241331|NCT02486406|FG002|Participant Flow|Mini Tablet, 9-11 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
11384768|NCT01589523|BG000|Baseline|Glycocholic Acid|15 milligrams/kilograms (mg/kg) of body weight/day (bw/day)
11384769|NCT01589523|FG000|Participant Flow|Glycocholic Acid|15 milligrams/kilograms (mg/kg) of body weight/day (bw/day)
11384770|NCT01589523|OG000|Outcome|15 mg/Kg Body Weight/Day|Open-label, no placebo group. Participants with bile acid conjugation defect confirmed by urine mass spectrometry analysis receiving glycocholic acid (15 mg/kg bw/day)
11384771|NCT01589523|OG000|Outcome|10-15 mg/Kg Body Weight/Day|Open-label, no placebo group. Participants with bile acid conjugation defect confirmed by urine mass spectrometry analysis receiving glycocholic acid (10-15 mg/kg bw/day)
11384772|NCT01589523|OG000|Outcome|Glycocholic Acid|15 milligrams/kilograms (mg/kg) of body weight/day (bw/day)
11384773|NCT01589523|EG000|Reported Event|Glycocholic Acid|15 mg/kg bw/day
11384774|NCT01566695|BG000|Baseline|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell [pRBC] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
11384775|NCT01566695|BG001|Baseline|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
11384776|NCT01566695|BG002|Baseline|Total|Total of all reporting groups
11384777|NCT01566695|FG000|Participant Flow|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell [pRBC] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
11384778|NCT01566695|FG001|Participant Flow|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
11384779|NCT01566695|OG000|Outcome|Oral Azacitidine and Best Supportive Care|Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell [pRBC] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
11384780|NCT01566695|OG001|Outcome|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
11384781|NCT01566695|EG000|Reported Event|Oral Azacitidine Plus Best Supportive Care|Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell [pRBC] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
11384782|NCT01566695|EG001|Reported Event|Placebo Plus Best Supportive Care|Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
11196623|NCT02165826|OG001|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196624|NCT02165826|OG002|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11384783|NCT01256398|BG000|Baseline|Treatment (Chemotherapy, Transplant)|"All enrolled patients.>~> Alemtuzumab: Given IV> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT> Cyclophosphamide: Given IV> Cytarabine: Given IV> Dasatinib: Given PO> Daunorubicin Hydrochloride: Given IV> Dexamethasone: Given PO or IV> Etoposide Phosphate: Given IV> Filgrastim: Given SC> Fludarabine Phosphate: Given IV> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT> Laboratory Biomarker Analysis: Correlative studies> Leucovorin Calcium: Given IV or PO> Melphalan: Given IV> Mercaptopurine: Given PO> Methotrexate: Given IT, IV, or PO> Pegfilgrastim: Given SC> Pharmacological Study: Correlative studies> Tacrolimus: Given IV or PO> Vincristine Sulfate: Given IV"
11384784|NCT01256398|FG000|Participant Flow|Treatment (Chemotherapy, Transplant)|"All enrolled patients.>~> Alemtuzumab: Given IV> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT> Cyclophosphamide: Given IV> Cytarabine: Given IV> Dasatinib: Given PO> Daunorubicin Hydrochloride: Given IV> Dexamethasone: Given PO or IV> Etoposide Phosphate: Given IV> Filgrastim: Given SC> Fludarabine Phosphate: Given IV> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT> Laboratory Biomarker Analysis: Correlative studies> Leucovorin Calcium: Given IV or PO> Melphalan: Given IV> Mercaptopurine: Given PO> Methotrexate: Given IT, IV, or PO> Pegfilgrastim: Given SC> Pharmacological Study: Correlative studies> Tacrolimus: Given IV or PO> Vincristine Sulfate: Given IV"
11384785|NCT01256398|OG000|Outcome|Treatment (Chemotherapy, Transplant)|"All enrolled patients that reached CR during induction and continued to course 5.>~> Alemtuzumab: Given IV> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT> Cyclophosphamide: Given IV> Cytarabine: Given IV> Dasatinib: Given PO> Daunorubicin Hydrochloride: Given IV> Dexamethasone: Given PO or IV> Etoposide Phosphate: Given IV> Filgrastim: Given SC> Fludarabine Phosphate: Given IV> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT> Laboratory Biomarker Analysis: Correlative studies> Leucovorin Calcium: Given IV or PO> Melphalan: Given IV> Mercaptopurine: Given PO> Methotrexate: Given IT, IV, or PO> Pegfilgrastim: Given SC> Pharmacological Study: Correlative studies> Tacrolimus: Given IV or PO> Vincristine Sulfate: Given IV"
11384786|NCT01256398|EG000|Reported Event|Treatment (Chemotherapy, Transplant)|Vincristine Sulfate: Given IV
11384787|NCT01157091|BG000|Baseline|Arm I|"Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
11384788|NCT01157091|FG000|Participant Flow|Oral Pazopanib HCl|"Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
11384789|NCT01157091|OG000|Outcome|Arm I|"Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
11384790|NCT01157091|EG000|Reported Event|Arm I|"Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
11384791|NCT01100775|BG000|Baseline|All Study Participants|All participants that were included in the study
11384792|NCT01100775|FG000|Participant Flow|Galantamine, Then Placebo|"Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.~Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.~Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing."
11384793|NCT01100775|FG001|Participant Flow|Placebo, Then Galantamine|"Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.~Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.~Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing."
11384794|NCT01100775|OG000|Outcome|Galantamine|Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
11384795|NCT01100775|OG001|Outcome|Placebo|Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
11384796|NCT01100775|EG000|Reported Event|Galantamine|Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
11384797|NCT01100775|EG001|Reported Event|Placebo|Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing.
11384798|NCT00777036|BG000|Baseline|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384799|NCT00777036|BG001|Baseline|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384800|NCT00777036|BG002|Baseline|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
10799812|NCT04066738|EG000|Reported Event|Patients With Myocardial Scar|"Patient with previous STEMI resulting in myocardial scar, elected to CRT implant~Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system~3D reconstruction and location of coronary sinus venous system relative to myocardial scar: Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar~Acute haemodynamic measurements during CRT implant: Advancement of pressure wire to LV cavity via femoral/radial arterial access.~Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)"
11384801|NCT00777036|BG003|Baseline|Total|Total of all reporting groups
11384802|NCT00777036|FG000|Participant Flow|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384803|NCT00777036|FG001|Participant Flow|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384804|NCT00777036|FG002|Participant Flow|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384805|NCT00777036|OG000|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384806|NCT00777036|OG000|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384807|NCT00777036|OG000|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384808|NCT00777036|OG001|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384809|NCT00777036|OG001|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384810|NCT00777036|OG002|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384811|NCT00777036|OG003|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384812|NCT00777036|OG004|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384813|NCT00777036|EG000|Reported Event|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384814|NCT00777036|EG001|Reported Event|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
11384815|NCT00777036|EG002|Reported Event|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
11384816|NCT00777036|EG003|Reported Event|Cohort 2: BP-CML Only|Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384817|NCT00777036|EG004|Reported Event|Cohort 2: Ph+ ALL Only|Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
11384818|NCT00504712|BG000|Baseline|Active|"Testosterone 200 mg intramuscular every 2 weeks~Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks"
11384819|NCT00504712|BG001|Baseline|Placebo|"Saline~saline: Saline injection every two weeks"
11384820|NCT00504712|BG002|Baseline|Total|Total of all reporting groups
11384821|NCT00504712|FG000|Participant Flow|Active|"Testosterone 200 mg intramuscular every 2 weeks~Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks"
11384822|NCT00504712|FG001|Participant Flow|Placebo|"Saline~saline: Saline injection every two weeks"
11384823|NCT00504712|OG000|Outcome|Active|"Testosterone 200 mg intramuscular every 2 weeks~Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks"
11384824|NCT00504712|OG001|Outcome|Placebo|"Saline~saline: Saline injection every two weeks"
11384825|NCT00504712|EG000|Reported Event|Active|"Testosterone 200 mg intramuscular every 2 weeks~Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks"
11384826|NCT00504712|EG001|Reported Event|Placebo|"Saline~saline: Saline injection every two weeks"
11384827|NCT05097157|BG000|Baseline|Treatment With Device|"Subjects received up to 5 treatments with the device, spaced 4 weeks apart.~Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body."
11384828|NCT05097157|FG000|Participant Flow|Treatment With Device|"Subjects received up to 5 treatments with the device, spaced 4 weeks apart.~Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body."
11384829|NCT05097157|OG000|Outcome|Treatment With Device|"Subjects received up to 5 treatments with the device, spaced 4 weeks apart.~Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body."
11384830|NCT05097157|EG000|Reported Event|Treatment With Device|"Subjects received up to 5 treatments with the device, spaced 4 weeks apart.~Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body."
11384831|NCT04331795|BG000|Baseline|Group A|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation~Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384832|NCT04331795|BG001|Baseline|Group B|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation~Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384833|NCT04331795|BG002|Baseline|Total|Total of all reporting groups
11384834|NCT04331795|FG000|Participant Flow|Group A|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation~Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384835|NCT04331795|FG001|Participant Flow|Group B|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation~Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384836|NCT04331795|OG000|Outcome|Group A|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation~Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384837|NCT04331795|OG001|Outcome|Group B|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation~Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384838|NCT04331795|EG000|Reported Event|Group A|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation~Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384839|NCT04331795|EG001|Reported Event|Group B|"Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation~Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.~Second dose is provisioned if:~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
11384840|NCT04175730|BG000|Baseline|MRI and Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies~Ultrasound and MRI: A single subsequent ultrasound guided prostate biopsy with MRI fusion"
11384841|NCT04175730|BG001|Baseline|Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies~Ultrasound: A single subsequent ultrasound guided prostate biopsy"
11384842|NCT04175730|BG002|Baseline|Total|Total of all reporting groups
11384843|NCT04175730|FG000|Participant Flow|MRI and Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies~Ultrasound and MRI: A single subsequent ultrasound guided prostate biopsy with MRI fusion"
11384844|NCT04175730|FG001|Participant Flow|Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies~Ultrasound: A single subsequent ultrasound guided prostate biopsy"
11384845|NCT04175730|OG000|Outcome|MRI and Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies~Ultrasound and MRI: A single subsequent ultrasound guided prostate biopsy with MRI fusion"
11384846|NCT04175730|OG001|Outcome|Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies~Ultrasound: A single subsequent ultrasound guided prostate biopsy"
11384847|NCT04175730|EG000|Reported Event|MRI and Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies~Ultrasound and MRI: A single subsequent ultrasound guided prostate biopsy with MRI fusion"
11384848|NCT04175730|EG001|Reported Event|Ultrasound|"men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies~Ultrasound: A single subsequent ultrasound guided prostate biopsy"
10799813|NCT03933020|BG000|Baseline|All Participants|The enrolled participants were lost to follow up before being assigned to any intervention.
10799814|NCT03933020|FG000|Participant Flow|All Participants|The enrolled participants were lost to follow up before being assigned to any intervention.
10799815|NCT03933020|OG000|Outcome|Exercise Group|"Virtual reality (VR) active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise~Educational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence."
10799816|NCT03933020|OG001|Outcome|Control Group|Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits
10799817|NCT03933020|OG000|Outcome|Exercise Group|"VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise~Educational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence."
10799818|NCT03933020|EG000|Reported Event|All Participants|The enrolled participants were lost to follow up before being assigned to any intervention.
10799819|NCT03793608|BG000|Baseline|Dupilumab|Participants enrolled under open-label treatment protocol with weight of greater than or equal to (>=) 20 kilograms (kg) and less than (<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of >=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
10799820|NCT03793608|FG000|Participant Flow|Placebo|Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
10799821|NCT03793608|FG001|Participant Flow|Dupilumab|Participants enrolled under open-label treatment protocol with weight of greater than or equal to (>=) 20 kilograms (kg) and less than (<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of >=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
10799822|NCT03793608|OG000|Outcome|Dupilumab|Participants enrolled under open-label treatment protocol with weight of greater than or equal to (>=) 20 kilograms (kg) and less than (<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of >=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
10799823|NCT03793608|EG000|Reported Event|Placebo|Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
11196625|NCT02165826|OG000|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
11196626|NCT02165826|OG001|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
11196627|NCT02165826|OG000|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
11196628|NCT02165826|OG001|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, tablets, orally, every other day (EOD) in the Main Period.
11196629|NCT02165826|OG002|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg tablets, orally, once daily in the Main Period.
11196630|NCT02165826|OG003|Outcome|Roflumilast 250 µg Down-Titration|250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
10799824|NCT03793608|EG001|Reported Event|Dupilumab|Participants enrolled under open-label treatment protocol with weight of greater than or equal to (>=) 20 kilograms (kg) and less than (<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of >=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
10799825|NCT03655054|BG000|Baseline|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
10799826|NCT03655054|FG000|Participant Flow|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
10799827|NCT03655054|OG000|Outcome|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
10799828|NCT03655054|EG000|Reported Event|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
10799829|NCT03601117|BG000|Baseline|Dorsolateral Prefrontal Cortex|The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
10799830|NCT03601117|BG001|Baseline|Anterior Cingulate Cortex (ACC)|The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
10799831|NCT03601117|BG002|Baseline|Total|Total of all reporting groups
11196631|NCT02165826|OG001|Outcome|Roflumilast 250 μg OD|Roflumilast 500 μg at least one dose in the Main Period followed by Roflumilast 250 μg tablets, orally, once daily in the Down -Titration Period.
11196632|NCT02165826|OG000|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
11196633|NCT02165826|OG001|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, orally, every other day (EOD) at least 1 dose in the Main Period
11384849|NCT03724487|BG000|Baseline|Coachman|"The first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support over 12 weeks.~TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure~Total of 30 individuals who:~self-identified as African American,~were 30 years of age or older,~had been diagnosed with hypertension (BP >140/90 mmHg) and prescribed an antihypertensive drug,~were able to read/understand English, and (5) owned a smartphone."
11384850|NCT03724487|BG001|Baseline|Enhanced Usual Care|"The second study condition, Enhanced Usual Care (EUC) will be exposed to routine and standard hypertension education materials and one session on self-monitoring blood pressure.~Enhanced Usual Care (EUC): Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.~30 individuals who:~self-identified as African American,~were 30 years of age or older,~had been diagnosed with hypertension (BP >140/90 mmHg) and prescribed an antihypertensive drug,~were able to read/understand English, and (5) owned a smartphone."
11384851|NCT03724487|BG002|Baseline|Total|Total of all reporting groups
11384852|NCT03724487|FG000|Participant Flow|Coachman|"The first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.~Coachman: Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure."
11384853|NCT03724487|FG001|Participant Flow|Enhanced Usual Care|"The second study condition, Enhanced Usual Care (EUC) will be exposed to routine and standard hypertension education materials and one session on self-monitoring blood pressure.~Enhanced Usual Care (EUC): Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure."
11384854|NCT03724487|OG000|Outcome|Coachman|This group was exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.
11384855|NCT03724487|OG001|Outcome|Enhanced Usual Care (EUC)|Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.
11384856|NCT03724487|OG000|Outcome|Coachman|"The first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.~Coachman: Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure."
11384857|NCT03724487|EG000|Reported Event|Coachman|"The first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.~Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure."
11384858|NCT03724487|EG001|Reported Event|Enhanced Usual Care|"The second study condition, Enhanced Usual Care (EUC) will be exposed to routine and standard hypertension education materials and one session on self-monitoring blood pressure.~Enhanced Usual Care (EUC): Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure."
11384859|NCT03703102|BG000|Baseline|KHK4083 150 mg SC Q4W|"Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384860|NCT03703102|BG001|Baseline|KHK4083 600 mg SC Q4W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384861|NCT03703102|BG002|Baseline|KHK4083 300 mg SC Q2W|Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384862|NCT03703102|BG003|Baseline|KHK4083 600 mg SC Q2W|Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384863|NCT03703102|BG004|Baseline|Placebo/KHK4083 600 mg|Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
11384864|NCT03703102|BG005|Baseline|Total|Total of all reporting groups
11384865|NCT03703102|FG000|Participant Flow|KHK4083 150 mg SC Q4W|"Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384866|NCT03703102|FG001|Participant Flow|KHK4083 600 mg SC Q4W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384867|NCT03703102|FG002|Participant Flow|KHK4083 300 mg SC Q2W|Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384868|NCT03703102|FG003|Participant Flow|KHK4083 600 mg SC Q2W|Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384869|NCT03703102|FG004|Participant Flow|Placebo/KHK4083 600 mg|Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
11384870|NCT03703102|OG000|Outcome|KHK4083 150 mg SC Q4W|"Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384871|NCT03703102|OG001|Outcome|KHK4083 600 mg SC Q4W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384872|NCT03703102|OG002|Outcome|KHK4083 300 mg SC Q2W|Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384873|NCT03703102|OG003|Outcome|KHK4083 600 mg SC Q2W|Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384874|NCT03703102|OG004|Outcome|Placebo/KHK4083 600 mg|Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
11384875|NCT03703102|OG000|Outcome|KHK4083 150 mg SC Q4W|"Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.~Weeks 40-56 visits are off-treatment."
11384876|NCT03703102|OG001|Outcome|KHK4083 600 mg SC Q4W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.~Weeks 40-56 visits are off-treatment."
11384877|NCT03703102|OG002|Outcome|KHK4083 300 mg SC Q2W|"Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.~Weeks 40-56 visits are off-treatment."
11384878|NCT03703102|OG003|Outcome|KHK4083 600 mg SC Q2W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.~Weeks 40-56 visits are off-treatment."
11384879|NCT03703102|OG004|Outcome|Placebo/KHK4083 600 mg|"Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.~Weeks 40-56 visits are off-treatment."
11384880|NCT03703102|EG000|Reported Event|KHK4083 150 mg SC Q4W|"Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11196634|NCT02165826|OG000|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 4|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 4.
11196635|NCT02165826|OG001|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 12|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 12.
11384881|NCT03703102|EG001|Reported Event|KHK4083 600 mg SC Q4W|"Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.~To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34."
11384882|NCT03703102|EG002|Reported Event|KHK4083 300 mg SC Q2W|Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384883|NCT03703102|EG003|Reported Event|KHK4083 600 mg SC Q2W|Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
11384884|NCT03703102|EG004|Reported Event|Placebo/KHK4083 600 mg|Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
11384885|NCT03395704|BG000|Baseline|LJPC-401|"LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial~LJPC-401: LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg."
11384886|NCT03395704|BG001|Baseline|Placebo|"0.9% Sodium Chloride Injection, USP, or equivalent~Placebo: 0.9% Sodium Chloride Injection, USP, or equivalent"
11384887|NCT03395704|BG002|Baseline|Total|Total of all reporting groups
11384888|NCT03395704|FG000|Participant Flow|LJPC-401|"LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial~LJPC-401: LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg."
11384889|NCT03395704|FG001|Participant Flow|Placebo|"0.9% Sodium Chloride Injection, USP, or equivalent~Placebo: 0.9% Sodium Chloride Injection, USP, or equivalent"
11384890|NCT03395704|OG000|Outcome|LJPC-401|"LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial~LJPC-401: LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg."
11384891|NCT03395704|OG001|Outcome|Placebo|"0.9% Sodium Chloride Injection, USP, or equivalent~Placebo: 0.9% Sodium Chloride Injection, USP, or equivalent"
11384892|NCT03395704|EG000|Reported Event|LJPC-401|"LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial~LJPC-401: LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg."
11384893|NCT03395704|EG001|Reported Event|Placebo|"0.9% Sodium Chloride Injection, USP, or equivalent~Placebo: 0.9% Sodium Chloride Injection, USP, or equivalent"
11384894|NCT03335813|BG000|Baseline|Brachytherapy With Multichannel Balloon Applicator|"6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors~Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation"
11384895|NCT03335813|FG000|Participant Flow|Brachytherapy With Multichannel Balloon Applicator|"6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors~Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation"
11384896|NCT03335813|OG000|Outcome|Brachytherapy With Multichannel Balloon Applicator|"6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors~Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation"
11384897|NCT03335813|EG000|Reported Event|Brachytherapy With Multichannel Balloon Applicator|"6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors~Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation"
11384898|NCT03246503|BG000|Baseline|Newborns|"Newborns will be enrolled in the study in 2 different ways. At Staged Enrollment sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At Simultaneous Enrollment sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.~BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care"
11384899|NCT03246503|FG000|Participant Flow|Newborns|"Newborns will be enrolled in the study in 2 different ways. At Staged Enrollment sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At Simultaneous Enrollment sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.~BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care"
10799832|NCT03601117|FG000|Participant Flow|Dorsolateral Prefrontal Cortex|The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
10799833|NCT03601117|FG001|Participant Flow|Anterior Cingulate Cortex (ACC)|The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
11384900|NCT03246503|OG000|Outcome|Newborns|"Newborns will be enrolled in the study in 2 different ways. At Staged Enrollment sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At Simultaneous Enrollment sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.~BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care"
11384901|NCT03246503|EG000|Reported Event|Newborns|"Newborns will be enrolled in the study in 2 different ways. At Staged Enrollment sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At Simultaneous Enrollment sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.~BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care"
11384902|NCT03039595|BG000|Baseline|Patients|All patients
11384903|NCT03039595|FG000|Participant Flow|Patients|All patients. This is an observational study; no interventions were used.
11384904|NCT03039595|OG000|Outcome|Patients|All patients
11384905|NCT03039595|EG000|Reported Event|Patients|All patients
10799834|NCT03601117|OG000|Outcome|Dorsolateral Prefrontal Cortex (L-DLPFC)|The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
10799835|NCT03601117|OG001|Outcome|Anterior Cingulate Cortex (ACC)|The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
10799836|NCT03601117|OG000|Outcome|Dorsolateral Prefrontal Cortex|The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
10799837|NCT03601117|OG001|Outcome|Anterior Cingulate Cortex|The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
10799838|NCT03601117|EG000|Reported Event|Dorsolateral Prefrontal Cortex (L-DLPFC)|"The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)~Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC (if participants do not respond to L-DLPFC stimulation, they may be offered stimulation at the ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered using the Brainsway TMS system."
10799839|NCT03601117|EG001|Reported Event|Anterior Cingulate Cortex (ACC)|"The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC)~Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the ACC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).~Stimulation will be delivered using the Brainsway TMS system."
10799840|NCT03542266|BG000|Baseline|CC486 +CHOP|"CC486 +CHOP~CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.~CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:~Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5"
10799841|NCT03542266|FG000|Participant Flow|CC486 +CHOP|"CC486 +CHOP~CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.~CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:~Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5"
10799842|NCT03542266|OG000|Outcome|CC486 +CHOP|"CC486 +CHOP~CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.~CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:~Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5"
10803542|NCT03600805|EG001|Reported Event|Placebo+26 Week Taper|Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
11196636|NCT02165826|EG000|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Main Treatment Period|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
10803543|NCT03600805|EG002|Reported Event|Sarilumab 150mg q2w+26 Week Taper|Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
11337898|NCT03596177|FG001|Participant Flow|MEDI0382|Participants received SC injection of placebo for 16 days in the single-blind treatment period, and then SC injection of MEDI0382 titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
11337899|NCT03596177|OG000|Outcome|Placebo|Participants received subcutaneous (SC) injection of placebo for 16 days in the single-blind treatment period, and then SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period.
11337900|NCT03596177|OG001|Outcome|MEDI0382|Participants received SC injection of placebo for 16 days in the single-blind treatment period, and then SC injection of MEDI0382 titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
11337901|NCT03596177|EG000|Reported Event|Placebo|Participants received subcutaneous (SC) injection of placebo for 16 days in the single-blind treatment period, and then SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period.
11337902|NCT03596177|EG001|Reported Event|MEDI0382|Participants received SC injection of placebo for 16 days in the single-blind treatment period, and then SC injection of MEDI0382 titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
11337903|NCT03596723|BG000|Baseline|KPI-121 1% BID (Twice Daily)|KPI-121 1%: eye drops
11337904|NCT03596723|BG001|Baseline|Prednisolone Acetate QID (Four Times Daily)|Prednisolone acetate: eye drops
11337905|NCT03596723|BG002|Baseline|Total|Total of all reporting groups
11337906|NCT03596723|FG000|Participant Flow|KPI-121 1% BID (Twice Daily)|Subjects randomized to KPI-121 1% eye drops
11337907|NCT03596723|FG001|Participant Flow|Prednisolone Acetate QID (Four Times Daily)|Subjects randomized to Prednisolone acetate eye drops
11337908|NCT03596723|OG000|Outcome|KPI-121 1% BID|KPI-121 1%: eye drops
11337909|NCT03596723|OG001|Outcome|Prednisolone Acetate QID|Prednisolone acetate: eye drops
11337910|NCT03596723|EG000|Reported Event|KPI-121 1% BID|KPI-121 1%: eye drops
11337911|NCT03596723|EG001|Reported Event|Prednisolone Acetate QID|Prednisolone acetate: eye drops
11337912|NCT03597009|BG000|Baseline|Open-label, Single-arm Phase I|"Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab~Talimogene laherparepvec (TVEC): Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab~Nivolumab: Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort"
11337913|NCT03597009|FG000|Participant Flow|Open-label, Single-arm Phase I|"Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab~Talimogene laherparepvec (TVEC): Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab~Nivolumab: Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort"
11337914|NCT03597009|OG000|Outcome|Open-label, Single-arm Phase I|"Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab~Talimogene laherparepvec (TVEC): Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab~Nivolumab: Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort"
11337915|NCT03597009|EG000|Reported Event|Open-label, Single-arm Phase I|"Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab~Talimogene laherparepvec (TVEC): Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab~Nivolumab: Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort"
11337916|NCT03597022|BG000|Baseline|BAY1093884 100mg|Subjects received BAY1093884 100 mg once a week until premature termination of the study
11337917|NCT03597022|BG001|Baseline|BAY1093884 225mg|Subjects received BAY1093884 225 mg once a week until premature termination of the study
11337918|NCT03597022|BG002|Baseline|BAY1093884 400mg|Subjects received BAY1093884 400mg once a week until premature termination of the study
11337919|NCT03597022|BG003|Baseline|Total|Total of all reporting groups
11337920|NCT03597022|FG000|Participant Flow|BAY1093884 100mg|Subjects received BAY1093884 100 mg once a week until premature termination of the study
11337921|NCT03597022|FG001|Participant Flow|BAY1093884 225mg|Subjects received BAY1093884 225 mg once a week until premature termination of the study
11337922|NCT03597022|FG002|Participant Flow|BAY1093884 400mg|Subjects received BAY1093884 400mg once a week until premature termination of the study
11337923|NCT03597022|OG000|Outcome|BAY1093884 100mg|Subjects received BAY1093884 100 mg once a week until premature termination of the study
11337924|NCT03597022|OG001|Outcome|BAY1093884 225mg|Subjects received BAY1093884 225 mg once a week until premature termination of the study
11337925|NCT03597022|OG002|Outcome|BAY1093884 400mg|Subjects received BAY1093884 400mg once a week until premature termination of the study
11337926|NCT03597022|EG000|Reported Event|BAY1093884 100mg|Subjects received BAY1093884 100 mg once a week until premature termination of the study
11337927|NCT03597022|EG001|Reported Event|BAY1093884 225mg|Subjects received BAY1093884 225 mg once a week until premature termination of the study
11337928|NCT03597022|EG002|Reported Event|BAY1093884 400mg|Subjects received BAY1093884 400 mg once a week until premature termination of the study
11196637|NCT02165826|EG001|Reported Event|Roflumilast 500 μg EOD Then 500 μg OD_Main Treatment Period|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196638|NCT02165826|EG002|Reported Event|Roflumilast 500 μg OD_Main Treatment Period|Roflumilast 500 μg tablets, orally, once daily for 12 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196639|NCT02165826|EG003|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196640|NCT02165826|EG004|Reported Event|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11384906|NCT02864368|BG000|Baseline|5-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384907|NCT02864368|BG001|Baseline|21-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384908|NCT02864368|BG002|Baseline|5-day TMZ: Safety Cohort|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384909|NCT02864368|BG003|Baseline|5-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11196641|NCT02165826|EG005|Reported Event|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
11196642|NCT02165839|BG000|Baseline|Healthy Eating Education Learning (HEAL)|Control group. Healthy Eating Education Learning (HEAL)
11196643|NCT02165839|BG001|Baseline|Brief Behavioral Therapy for Insomnia (BBT-I)|Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
10799843|NCT03542266|EG000|Reported Event|CC486 +CHOP|"CC486 +CHOP~CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.~CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:~Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5"
10799844|NCT03529409|BG000|Baseline|Project Khanya|"Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.~Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence."
10799845|NCT03529409|BG001|Baseline|ESOC|Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
10799846|NCT03529409|BG002|Baseline|Pre-Randomization|Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and did not continue with the study.
10799847|NCT03529409|BG003|Baseline|Total|Total of all reporting groups
10799848|NCT03529409|FG000|Participant Flow|Project Khanya|"Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.~Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence."
10799849|NCT03529409|FG001|Participant Flow|ESOC|Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
10799850|NCT03529409|FG002|Participant Flow|Pre-Randomization|Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and therefore did not continue with the study.
10799851|NCT03529409|OG000|Outcome|Project Khanya|"Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.~Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence."
10799852|NCT03529409|OG001|Outcome|ESOC|Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
10799853|NCT03529409|EG000|Reported Event|Project Khanya|"Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.~Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence."
11196644|NCT02165839|BG002|Baseline|Total|Total of all reporting groups
11196645|NCT02165839|FG000|Participant Flow|Healthy Eating Education Learning (HEAL)|Control group. Healthy Eating Education Learning (HEAL)
11196646|NCT02165839|FG001|Participant Flow|Brief Behavioral Therapy for Insomnia (BBT-I)|Experimental Group. Brief Behavioral Therapy for Insomnia (BBT-I)
11196647|NCT02165839|OG000|Outcome|Healthy Eating Education Learning (HEAL)|Control group. Healthy Eating Education Learning (HEAL)
11196648|NCT02165839|OG001|Outcome|Brief Behavioral Therapy for Insomnia (BBT-I)|Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
11196649|NCT02165839|OG001|Outcome|Brief Behavioral Therapy for Insomnia (BBT-I)|Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I).
11196650|NCT02165839|EG000|Reported Event|Healthy Eating Education Learning (HEAL)|Control group. Healthy Eating Education Learning (HEAL)
11196651|NCT02165839|EG001|Reported Event|Brief Behavioral Therapy for Insomnia (BBT-I)|Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
10799854|NCT03529409|EG001|Reported Event|ESOC|Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
11384910|NCT02864368|BG004|Baseline|21-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11384911|NCT02864368|BG005|Baseline|Total|Total of all reporting groups
11384912|NCT02864368|FG000|Participant Flow|5-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384913|NCT02864368|FG001|Participant Flow|21-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384914|NCT02864368|FG002|Participant Flow|5-day TMZ: Safety Cohort|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384915|NCT02864368|FG003|Participant Flow|5-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
10799855|NCT03529409|EG002|Reported Event|Pre-Randomization|Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and did not continue with the study.
10799856|NCT03516812|BG000|Baseline|Treatment (Olaparib, Testosterone Enanthate or Cypionate)|"Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Olaparib: Given PO~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Testosterone Enanthate: Given IM~Testosterone Cypionate: Given IM"
10799857|NCT03516812|FG000|Participant Flow|Treatment (Olaparib, Testosterone Enanthate or Cypionate)|"Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Olaparib: Given PO~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Testosterone Enanthate: Given IM~Testosterone Cypionate: Given IM"
10799858|NCT03516812|OG000|Outcome|Treatment (Olaparib, Testosterone Enanthate or Cypionate)|"Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Olaparib: Given PO~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Testosterone Enanthate: Given IM~Testosterone Cypionate: Given IM"
10799859|NCT03516812|EG000|Reported Event|Treatment (Olaparib, Testosterone Enanthate or Cypionate)|"Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Olaparib: Given PO~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Testosterone Enanthate: Given IM~Testosterone Cypionate: Given IM"
10799860|NCT03477396|BG000|Baseline|Treatment (Ribociclib, Aromatase Inhibitor)|"Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion~Laboratory Biomarker Analysis: Correlative studies~Pharmacokinetic Study: Correlative studies~Questionnaire Administration: Ancillary studies~Ribociclib: Given PO"
10799861|NCT03477396|FG000|Participant Flow|Treatment (Ribociclib, Aromatase Inhibitor)|"Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion~Laboratory Biomarker Analysis: Correlative studies~Pharmacokinetic Study: Correlative studies~Questionnaire Administration: Ancillary studies~Ribociclib: Given PO"
10799862|NCT03477396|OG000|Outcome|Treatment (Ribociclib, Aromatase Inhibitor)|"Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion~Laboratory Biomarker Analysis: Correlative studies~Pharmacokinetic Study: Correlative studies~Questionnaire Administration: Ancillary studies~Ribociclib: Given PO"
10799863|NCT03477396|EG000|Reported Event|Treatment (Ribociclib, Aromatase Inhibitor)|"Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion~Laboratory Biomarker Analysis: Correlative studies~Pharmacokinetic Study: Correlative studies~Questionnaire Administration: Ancillary studies~Ribociclib: Given PO"
10799864|NCT03463577|BG000|Baseline|Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10799865|NCT03463577|BG001|Baseline|Unexposed Historical Cohort Women|This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
11241332|NCT02486406|FG003|Participant Flow|Mini Tablet, 3-8 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
11241333|NCT02486406|OG000|Outcome|15 - 29 kg Body Weight|Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
11241334|NCT02486406|OG001|Outcome|30 - 44 kg Body Weight|Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
10799866|NCT03463577|BG002|Baseline|Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10799867|NCT03463577|BG003|Baseline|Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
10799868|NCT03463577|BG004|Baseline|Unexposed Historical Cohort Infants|This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
10799869|NCT03463577|BG005|Baseline|Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
10799870|NCT03463577|BG006|Baseline|Total|Total of all reporting groups
10799871|NCT03463577|FG000|Participant Flow|Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
11241335|NCT02486406|OG002|Outcome|≥ 45 kg Body Weight|Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
10799872|NCT03463577|FG001|Participant Flow|Unexposed Historical Cohort Women|This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
11384916|NCT02864368|FG004|Participant Flow|21-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11384917|NCT02864368|OG000|Outcome|5-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384918|NCT02864368|OG001|Outcome|21-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384919|NCT02864368|OG002|Outcome|5-day TMZ: Safety Cohort|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
10965806|NCT00884117|BG000|Baseline|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965807|NCT00884117|FG000|Participant Flow|All Participants Infected With Influenza|Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11241336|NCT02486406|OG000|Outcome|All Participants, Total|All participants who received at least one dose of study drug in Part 1 or Part 2
10799873|NCT03463577|FG002|Participant Flow|Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10799874|NCT03463577|FG003|Participant Flow|Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
10799875|NCT03463577|FG004|Participant Flow|Unexposed Historical Cohort Infants|This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
10965808|NCT00884117|OG000|Outcome|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10799876|NCT03463577|FG005|Participant Flow|Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
10799877|NCT03463577|OG000|Outcome|Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10965809|NCT00884117|OG000|Outcome|Children <1 Year of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965810|NCT00884117|OG001|Outcome|Children 1 to 5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 1 to 5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965811|NCT00884117|OG002|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965812|NCT00884117|OG003|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965813|NCT00884117|OG004|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965814|NCT00884117|OG005|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11196652|NCT02165904|BG000|Baseline|Autologous Mesenchymal Bone Marrow Cell|Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
11384920|NCT02864368|OG003|Outcome|5-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
10799878|NCT03463577|OG001|Outcome|Unexposed Historical Cohort Women|This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
10799879|NCT03463577|OG000|Outcome|Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
10799880|NCT03463577|OG001|Outcome|Unexposed Historical Cohort Infants|This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
11384921|NCT02864368|OG004|Outcome|21-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11384922|NCT02864368|OG000|Outcome|5-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed) Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384923|NCT02864368|OG001|Outcome|21-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle) PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed) Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384924|NCT02864368|OG002|Outcome|5-day TMZ: Safety Cohort|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed) Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384925|NCT02864368|OG000|Outcome|5-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11384926|NCT02864368|OG001|Outcome|21-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11241337|NCT02486406|OG000|Outcome|Adult Tablet, 12-17 YR, ≥ 45 kg|Participants age 12-17 years old who received the adult formulation and weighed ≥ 45 kg
11196653|NCT02165904|FG000|Participant Flow|Autologous Mesenchymal Bone Marrow Cell|Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
11384927|NCT02864368|EG000|Reported Event|5-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384928|NCT02864368|EG001|Reported Event|21-day TMZ: Components A and B|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384929|NCT02864368|EG002|Reported Event|5-day TMZ: Safety Cohort|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine. Vaccine components A and B were administered separately, with a delay between them, to determine if it was an individual component or a combination of the components that resulted in adverse reactions.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ~PEP-CMV: Component B: 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered"
11384930|NCT02864368|EG003|Reported Event|5-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~5-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
10799881|NCT03463577|OG000|Outcome|Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10799882|NCT03463577|OG000|Outcome|Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
10799883|NCT03463577|EG000|Reported Event|Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
11241338|NCT02486406|OG001|Outcome|Mini-tablet, 9-11 YR, 15 to 29 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed 15 to 29 kg
11241339|NCT02486406|OG002|Outcome|Mini-tablet, 9-11 YR, 30 to 44 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed 30 to 44 kg
11196654|NCT02165904|OG000|Outcome|Autologous Mesenchymal Bone Marrow Cell|Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
11196655|NCT02165904|EG000|Reported Event|Autologous Mesenchymal Bone Marrow Cell|Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
11196656|NCT02166047|BG000|Baseline|Vesatolimod 1 mg 4 Weeks (Cohort A)|Vesatolimod 1 mg tablet once a week for 4 weeks
11384931|NCT02864368|EG004|Reported Event|21-day TMZ: Component A Alone|"All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.~21-day TMZ: Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)~PEP-CMV: Component A: 500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered~Tetanus-Diphtheria booster: At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)~Tetanus Pre-Conditioning: All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ"
11384932|NCT02856698|BG000|Baseline|Midazolam|"The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.~Midazolam: Dose use according to the product technical sheet"
11384933|NCT02856698|BG001|Baseline|Morphine|"The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE~Morphine: Dose use according to the product technical sheet"
11384934|NCT02856698|BG002|Baseline|Total|Total of all reporting groups
11384935|NCT02856698|FG000|Participant Flow|Midazolam|"The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.~Midazolam: Dose use according to the product technical sheet"
11384936|NCT02856698|FG001|Participant Flow|Morphine|"The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE~Morphine: Dose use according to the product technical sheet"
11196657|NCT02166047|BG001|Baseline|Vesatolimod 2 mg 4 Weeks (Cohort A)|Vesatolimod 2 mg tablet once a week for 4 weeks
11196658|NCT02166047|BG002|Baseline|Vesatolimod 4 mg 4 Weeks (Cohort A)|Vesatolimod 4 mg tablet once a week for 4 weeks
11196659|NCT02166047|BG003|Baseline|Placebo 4 Weeks (Cohort A)|Placebo tablet once a week for 4 weeks
11196660|NCT02166047|BG004|Baseline|Vesatolimod 1 mg 8 Weeks (Cohort B)|Vesatolimod 1 mg tablet once a week for 8 weeks
11196661|NCT02166047|BG005|Baseline|Vesatolimod 2 mg 8 Weeks (Cohort B)|Vesatolimod 2 mg tablet once a week for 8 weeks
11196662|NCT02166047|BG006|Baseline|Vesatolimod 4 mg 8 Weeks (Cohort B)|Vesatolimod 4 mg tablet once a week for 8 weeks
11196663|NCT02166047|BG007|Baseline|Placebo 8 Weeks (Cohort B)|Placebo tablet once a week for 8 weeks
11196664|NCT02166047|BG008|Baseline|Vesatolimod 1 mg 12 Weeks (Cohort C)|Vesatolimod 1 mg tablet once a week for 12 weeks
11196665|NCT02166047|BG009|Baseline|Vesatolimod 2 mg 12 Weeks (Cohort C)|Vesatolimod 2 mg tablet once a week for 12 weeks
11196666|NCT02166047|BG010|Baseline|Vesatolimod 4 mg 12 Weeks (Cohort C)|Vesatolimod 4 mg tablet once a week for 12 weeks
11196667|NCT02166047|BG011|Baseline|Placebo 12 Weeks (Cohort C)|Placebo tablet once a week for 12 weeks
11196668|NCT02166047|BG012|Baseline|Total|Total of all reporting groups
11196669|NCT02166047|FG000|Participant Flow|Vesatolimod 1 mg 4 Weeks (Cohort A)|Vesatolimod 1 mg tablet once a week for 4 weeks
11196670|NCT02166047|FG001|Participant Flow|Vesatolimod 2 mg 4 Weeks (Cohort A)|Vesatolimod 2 mg tablet once a week for 4 weeks
11196671|NCT02166047|FG002|Participant Flow|Vesatolimod 4 mg 4 Weeks (Cohort A)|Vesatolimod 4 mg tablet once a week for 4 weeks
11384937|NCT02856698|OG000|Outcome|Midazolam|"The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.~Midazolam: Dose use according to the product technical sheet"
11384938|NCT02856698|OG001|Outcome|Morphine|"The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE~Morphine: Dose use according to the product technical sheet"
11384939|NCT02856698|EG000|Reported Event|Midazolam|"The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.~Midazolam: Dose use according to the product technical sheet"
11384940|NCT02856698|EG001|Reported Event|Morphine|"The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE~Morphine: Dose use according to the product technical sheet"
11384941|NCT02625610|BG000|Baseline|Chemotherapy + Best Supportive Care (BSC)|Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
11196672|NCT02166047|FG003|Participant Flow|Placebo 4 Weeks (Cohort A)|Placebo tablet once a week for 4 weeks
11196673|NCT02166047|FG004|Participant Flow|Vesatolimod 1 mg 8 Weeks (Cohort B)|Vesatolimod 1 mg tablet once a week for 8 weeks
11384942|NCT02625610|BG001|Baseline|Avelumab|"Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase.~In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation."
11384943|NCT02625610|BG002|Baseline|Total|Total of all reporting groups
11384944|NCT02625610|FG000|Participant Flow|Chemotherapy + Best Supportive Care (BSC)|Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
10799884|NCT03463577|EG001|Reported Event|Unexposed Historical Cohort Women|This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
11384945|NCT02625610|FG001|Participant Flow|Avelumab|"Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase.~In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation."
10799885|NCT03463577|EG002|Reported Event|Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy|This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
10799886|NCT03463577|EG003|Reported Event|Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
10799887|NCT03463577|EG004|Reported Event|Unexposed Historical Cohort Infants|This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
10799888|NCT03463577|EG005|Reported Event|Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy|This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
10799889|NCT03373760|BG000|Baseline|Primary PD-(L)1 Resistance Cohort|Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.
10799890|NCT03373760|BG001|Baseline|Acquired PD-(L)1 Resistance Cohort|Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.
10799891|NCT03373760|BG002|Baseline|Total|Total of all reporting groups
11196674|NCT02166047|FG005|Participant Flow|Vesatolimod 2 mg 8 Weeks (Cohort B)|Vesatolimod 2 mg tablet once a week for 8 weeks
11196675|NCT02166047|FG006|Participant Flow|Vesatolimod 4 mg 8 Weeks (Cohort B)|Vesatolimod 4 mg tablet once a week for 8 weeks
11196676|NCT02166047|FG007|Participant Flow|Placebo 8 Weeks (Cohort B)|Placebo tablet once a week for 8 weeks
11196677|NCT02166047|FG008|Participant Flow|Vesatolimod 1 mg 12 Weeks (Cohort C)|Vesatolimod 1 mg tablet once a week for 12 weeks
11196678|NCT02166047|FG009|Participant Flow|Vesatolimod 2 mg 12 Weeks (Cohort C)|Vesatolimod 2 mg tablet once a week for 12 weeks
11196679|NCT02166047|FG010|Participant Flow|Vesatolimod 4 mg 12 Weeks (Cohort C)|Vesatolimod 4 mg tablet once a week for 12 weeks
11196680|NCT02166047|FG011|Participant Flow|Placebo 12 Weeks (Cohort C)|Placebo tablet once a week for 12 weeks
11196681|NCT02166047|OG000|Outcome|Vesatolimod 1 mg 4 Weeks (Cohort A)|Vesatolimod 1 mg tablet once a week for 4 weeks
11196682|NCT02166047|OG001|Outcome|Vesatolimod 2 mg 4 Weeks (Cohort A)|Vesatolimod 2 mg tablet once a week for 4 weeks
11196683|NCT02166047|OG002|Outcome|Vesatolimod 4 mg 4 Weeks (Cohort A)|Vesatolimod 4 mg tablet once a week for 4 weeks
11196684|NCT02166047|OG003|Outcome|Placebo 4 Weeks (Cohort A)|Placebo tablet once a week for 4 weeks
11196685|NCT02166047|OG004|Outcome|Vesatolimod 1 mg 8 Weeks (Cohort B)|Vesatolimod 1 mg tablet once a week for 8 weeks
10799892|NCT03373760|FG000|Participant Flow|Treatment (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Tremelimumab: Given IV"
10799893|NCT03373760|OG000|Outcome|Primary PD-(L)1 Resistance Cohort|Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.
10799894|NCT03373760|OG001|Outcome|Acquired PD-(L)1 Resistance Cohort|Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.
10799895|NCT03373760|OG000|Outcome|Treatment (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Durvalumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Tremelimumab: Given IV"
10799896|NCT03373760|OG000|Outcome|MEDI4736 + Tremelimumab|"Participants receive tremelimumab and durvalumab on day 1 of each 28-day cycle for four cycles. Starting at cycle 5, participants receive durvalumab on day 1 of each cycle until disease progression or unacceptable toxicity.~Tremelimumab: Given IV Durvalumab: Given IV"
10799897|NCT03373760|EG000|Reported Event|MEDI4736 + Tremelimumab|"Participants receive tremelimumab and durvalumab on day 1 of each 28-day cycle for four cycles. Starting at cycle 5, participants receive durvalumab on day 1 of each cycle until disease progression or unacceptable toxicity.~Tremelimumab: Given IV Durvalumab: Given IV"
10803544|NCT03600805|EG003|Reported Event|Sarilumab 200mg q2w+26 Week Taper|Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
10803545|NCT03584724|BG000|Baseline|Norflo Oro|"The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes"
10803546|NCT03584724|BG001|Baseline|Placebo for Norflo Oro|"The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo."
10803547|NCT03584724|BG002|Baseline|Total|Total of all reporting groups
10803548|NCT03584724|FG000|Participant Flow|Norflo Oro|"The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes"
10803549|NCT03584724|FG001|Participant Flow|Placebo for Norflo Oro|"The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo."
10803550|NCT03584724|OG000|Outcome|Norflo Oro|"The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes"
10803551|NCT03584724|OG001|Outcome|Placebo for Norflo Oro|"The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo."
10803552|NCT03584724|EG000|Reported Event|Norflo Oro|"The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Norflo Oro: Norflo Oro is highly bioavailable curcumin complexed into phytosomes"
10803553|NCT03584724|EG001|Reported Event|Placebo for Norflo Oro|"The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.~Placebo for Norflo Oro: Placebo consist of look-alike single foil pouches without active ingredient of Norflo."
11196686|NCT02166047|OG005|Outcome|Vesatolimod 2 mg 8 Weeks (Cohort B)|Vesatolimod 2 mg tablet once a week for 8 weeks
10803554|NCT03434119|BG000|Baseline|Soliqua 100/33|Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.
10803555|NCT03434119|BG001|Baseline|Lantus|Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
10803556|NCT03434119|BG002|Baseline|Total|Total of all reporting groups
10803557|NCT03434119|FG000|Participant Flow|Soliqua 100/33|Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
11196687|NCT02166047|OG006|Outcome|Vesatolimod 4 mg 8 Weeks (Cohort B)|Vesatolimod 4 mg tablet once a week for 8 weeks
10803558|NCT03434119|FG001|Participant Flow|Lantus|Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
10803559|NCT03434119|OG000|Outcome|Soliqua 100/33|Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.
11196688|NCT02166047|OG007|Outcome|Placebo 8 Weeks (Cohort B)|Placebo tablet once a week for 8 weeks
10799898|NCT03253627|BG000|Baseline|MBSR|"Mindfulness-Based Stress Reduction~Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning."
10799899|NCT03253627|BG001|Baseline|Health Enhancement Program|"Health Enhancement Program~Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule."
10799900|NCT03253627|BG002|Baseline|Total|Total of all reporting groups
10799901|NCT03253627|FG000|Participant Flow|MBSR|"Mindfulness-Based Stress Reduction~Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning."
10799902|NCT03253627|FG001|Participant Flow|Health Enhancement Program|"Health Enhancement Program~Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule."
10799903|NCT03253627|OG000|Outcome|MBSR|"Mindfulness-Based Stress Reduction~Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning."
10799904|NCT03253627|OG001|Outcome|Health Enhancement Program|"Health Enhancement Program~Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule."
10799905|NCT03253627|EG000|Reported Event|MBSR|"Mindfulness-Based Stress Reduction~Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning."
10799906|NCT03253627|EG001|Reported Event|Health Enhancement Program|"Health Enhancement Program~Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule."
10799907|NCT03202628|BG000|Baseline|Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)|"INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity.> > TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT.>~> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity.>~> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.>~> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT>~> Dexamethasone: Given PO>~> Ixazomib Citrate: Given PO>~> Laboratory Biomarker Analysis: Correlative studies>~> Pomalidomide: Given PO"
10799908|NCT03202628|FG000|Participant Flow|Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)|"INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity.~>~> TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT.~>~> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity.~>~> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~>~> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~>~> Dexamethasone: Given PO~>~> Ixazomib Citrate: Given PO~>~> Laboratory Biomarker Analysis: Correlative studies~>~> Pomalidomide: Given PO"
10803560|NCT03434119|OG001|Outcome|Lantus|Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
10803561|NCT03434119|EG000|Reported Event|Soliqua 100/33|Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.
10803562|NCT03434119|EG001|Reported Event|Lantus|Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
11196689|NCT02166047|OG008|Outcome|Vesatolimod 1 mg 12 Weeks (Cohort C)|Vesatolimod 1 mg tablet once a week for 12 weeks
11196690|NCT02166047|OG009|Outcome|Vesatolimod 2 mg 12 Weeks (Cohort C)|Vesatolimod 2 mg tablet once a week for 12 weeks
11196691|NCT02166047|OG010|Outcome|Vesatolimod 4 mg 12 Weeks (Cohort C)|Vesatolimod 4 mg tablet once a week for 12 weeks
11196692|NCT02166047|OG011|Outcome|Placebo 12 Weeks (Cohort C)|Placebo tablet once a week for 12 weeks
11196693|NCT02166047|EG000|Reported Event|Vesatolimod 1 mg 4 Weeks (Cohort A)|Vesatolimod 1 mg tablet once a week for 4 weeks
11384946|NCT02625610|OG000|Outcome|Chemotherapy + Best Supportive Care (BSC)|Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
11384947|NCT02625610|OG001|Outcome|Avelumab|"Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase.~In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation."
11384948|NCT02625610|EG000|Reported Event|Chemotherapy + Best Supportive Care (BSC)|Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
11384949|NCT02625610|EG001|Reported Event|Avelumab|"Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase.~In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation."
11384950|NCT02514447|BG000|Baseline|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebos~Topotecan"
11384951|NCT02514447|BG001|Baseline|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11384952|NCT02514447|BG002|Baseline|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11384953|NCT02514447|BG003|Baseline|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²)."
11384954|NCT02514447|BG004|Baseline|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²)."
11384955|NCT02514447|BG005|Baseline|Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384956|NCT02514447|BG006|Baseline|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11196694|NCT02166047|EG001|Reported Event|Vesatolimod 2 mg 4 Weeks (Cohort A)|Vesatolimod 2 mg tablet once a week for 4 weeks
11196695|NCT02166047|EG002|Reported Event|Vesatolimod 4 mg 4 Weeks (Cohort A)|Vesatolimod 4 mg tablet once a week for 4 weeks
11196696|NCT02166047|EG003|Reported Event|Placebo 4 Weeks (Cohort A)|Placebo tablet once a week for 4 weeks
10799909|NCT03202628|OG000|Outcome|Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)|"INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity.~>~> TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT.~>~> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity.~>~> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~>~> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~>~> Dexamethasone: Given PO~>~> Ixazomib Citrate: Given PO~>~> Laboratory Biomarker Analysis: Correlative studies~>~> Pomalidomide: Given PO"
10799910|NCT03202628|EG000|Reported Event|Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)|Pomalidomide: Given PO
10799911|NCT03168555|BG000|Baseline|Intervention|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799912|NCT03168555|FG000|Participant Flow|Intervention|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799913|NCT03168555|OG000|Outcome|Visit 1|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799914|NCT03168555|OG001|Outcome|Visit 2|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799915|NCT03168555|OG000|Outcome|Intervention|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
11384957|NCT02514447|BG007|Baseline|Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1|"Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384958|NCT02514447|BG008|Baseline|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²)."
10799916|NCT03168555|EG000|Reported Event|Visit 1|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799917|NCT03168555|EG001|Reported Event|Visit 2|"chenodeoxycholic acid 1250mg po.~chenodeoxycholic acid: 1250 mg CDCA is given with a study meal"
10799918|NCT03135119|BG000|Baseline|TF-CBT|"Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy~TF-CBT: TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development."
10799919|NCT03135119|BG001|Baseline|TF-CBT+AAT|"Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.~TF-CBT+AAT: TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions."
10799920|NCT03135119|BG002|Baseline|Total|Total of all reporting groups
10799921|NCT03135119|FG000|Participant Flow|TF-CBT|"Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy~TF-CBT: TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development."
10799922|NCT03135119|FG001|Participant Flow|TF-CBT+AAT|"Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.~TF-CBT+AAT: TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions."
10799923|NCT03135119|OG000|Outcome|TF-CBT|"Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy~TF-CBT: TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development."
10799924|NCT03135119|OG001|Outcome|TF-CBT+AAT|"Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.~TF-CBT+AAT: TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions."
11196697|NCT02166047|EG004|Reported Event|Vesatolimod 1 mg 8 Weeks (Cohort B)|Vesatolimod 1 mg tablet once a week for 8 weeks
11384959|NCT02514447|BG009|Baseline|Total|Total of all reporting groups
11196698|NCT02166047|EG005|Reported Event|Vesatolimod 2 mg 8 Weeks (Cohort B)|Vesatolimod 2 mg tablet once a week for 8 weeks
11384960|NCT02514447|FG000|Participant Flow|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebo~Topotecan"
11384961|NCT02514447|FG001|Participant Flow|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11384962|NCT02514447|FG002|Participant Flow|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11384963|NCT02514447|FG003|Participant Flow|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²)."
11384964|NCT02514447|FG004|Participant Flow|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²)."
11384965|NCT02514447|FG005|Participant Flow|Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384966|NCT02514447|FG006|Participant Flow|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384967|NCT02514447|FG007|Participant Flow|Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1|"Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384968|NCT02514447|FG008|Participant Flow|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²)."
11384969|NCT02514447|OG000|Outcome|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebo~Topotecan"
11384970|NCT02514447|OG001|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11384971|NCT02514447|OG002|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11384972|NCT02514447|OG003|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²)."
11384973|NCT02514447|OG004|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²)."
11384974|NCT02514447|OG005|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384975|NCT02514447|OG006|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
10803563|NCT03417245|BG000|Baseline|Factor On-demand|Participants received on-demand factor concentrates (as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion for the treatment of breakthrough bleeding episodes from Day 1 up to a total of 9 months.
11196699|NCT02166047|EG006|Reported Event|Vesatolimod 4 mg 8 Weeks (Cohort B)|Vesatolimod 4 mg tablet once a week for 8 weeks
11196700|NCT02166047|EG007|Reported Event|Placebo 8 Weeks (Cohort B)|Placebo tablet once a week for 8 weeks
11196701|NCT02166047|EG008|Reported Event|Vesatolimod 1 mg 12 Weeks (Cohort C)|Vesatolimod 1 mg tablet once a week for 12 weeks
11196702|NCT02166047|EG009|Reported Event|Vesatolimod 2 mg 12 Weeks (Cohort C)|Vesatolimod 2 mg tablet once a week for 12 weeks
11196703|NCT02166047|EG010|Reported Event|Vesatolimod 4 mg 12 Weeks (Cohort C)|Vesatolimod 4 mg tablet once a week for 12 weeks
11384976|NCT02514447|OG007|Outcome|Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1|"Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11384977|NCT02514447|OG008|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²)."
11384978|NCT02514447|OG000|Outcome|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebos~Topotecan"
11384979|NCT02514447|OG000|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384980|NCT02514447|OG001|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 2|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384981|NCT02514447|OG002|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 3|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384982|NCT02514447|OG003|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 6|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384983|NCT02514447|OG004|Outcome|Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 5|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384984|NCT02514447|OG005|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 7|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
10803564|NCT03417245|BG001|Baseline|Fitusiran 80 mg Prophylaxis|Participants received open-label fitusiran 80 milligram (mg) administered subcutaneously (SC) as prophylaxis once monthly from Day 1 up to a total of 9 months. Participants received on-demand factor concentrates (per investigator's discretion and within bleeding dosing guidelines) for the treatment of breakthrough bleeding episodes.
10803565|NCT03417245|BG002|Baseline|Total Title|
11196704|NCT02166047|EG011|Reported Event|Placebo 12 Weeks (Cohort C)|Placebo tablet once a week for 12 weeks
11196705|NCT02166333|BG000|Baseline|200 IU/d|The 200 IU/d group is the control group.
11196706|NCT02166333|BG001|Baseline|1000 IU/d|During dose-finding, the 1000 IU/d dose was identified as the best of the non-control doses for fall prevention.
11384985|NCT02514447|OG000|Outcome|Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384986|NCT02514447|OG001|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384987|NCT02514447|OG002|Outcome|Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384988|NCT02514447|OG003|Outcome|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebos~Topotecan"
11384989|NCT02514447|OG004|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11384990|NCT02514447|OG005|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11384991|NCT02514447|OG000|Outcome|Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11196707|NCT02166333|BG002|Baseline|2000 IU/d|Randomization to the 2000 IU/d group was stopped in February 2018 as part of planned dose-finding.
11384992|NCT02514447|OG001|Outcome|Trilaciclib (G1T28) + Topotecan 1 mg/m²- Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384993|NCT02514447|OG002|Outcome|Trilaciclib (G1T28) + Topotecan 1.25 mg/m²- Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).~Trilaciclib~Topotecan"
11384994|NCT02514447|OG003|Outcome|Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- Part 1|"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²)."
11384995|NCT02514447|OG004|Outcome|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebos~Topotecan"
11384996|NCT02514447|OG005|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11384997|NCT02514447|OG006|Outcome|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11384998|NCT02514447|EG000|Reported Event|Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b|"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Placebos~Topotecan"
11384999|NCT02514447|EG001|Reported Event|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a|"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).~Trilaciclib~Topotecan"
11385000|NCT02514447|EG002|Reported Event|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b|"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).~Trilaciclib~Topotecan"
11385001|NCT02514447|EG003|Reported Event|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²)."
11385002|NCT02514447|EG004|Reported Event|Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²)."
10799925|NCT03135119|EG000|Reported Event|TF-CBT|"Youth will receive standard Trauma-Focused Cognitive-Behavioral Therapy~TF-CBT: TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development."
11196708|NCT02166333|BG003|Baseline|4000 IU/d|Randomization to the 4000 IU/d group was stopped in March 2018 as part of planned dose-finding.
11196709|NCT02166333|BG004|Baseline|Total|Total of all reporting groups
11241340|NCT02486406|OG003|Outcome|Mini-tablet, 9-11 YR, ≥ 45 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed ≥ 45 kg
11385003|NCT02514447|EG005|Reported Event|Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1|"Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11385004|NCT02514447|EG006|Reported Event|Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11385005|NCT02514447|EG007|Reported Event|Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1|"Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²)."
11385006|NCT02514447|EG008|Reported Event|Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1|"Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²)."
11385007|NCT02288247|BG000|Baseline|Enzalutamide|Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules/placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB treatment in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385008|NCT02288247|FG000|Participant Flow|Enzalutamide|Participants received an OL treatment with enzalutamide 160 milligrams (mg) capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 milligrams per square meter (mg/m^2) in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB treatment in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385009|NCT02288247|FG001|Participant Flow|Placebo|Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385010|NCT02288247|OG000|Outcome|Enzalutamide|Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385011|NCT02288247|OG001|Outcome|Placebo|Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385012|NCT02288247|OG001|Outcome|Placebo|Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in DB treatment period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants could continue the extension period if they were still receiving study drug in Period 1 when enrollment to Period 2 closed or when the data cut-off for analysis was reached in Period 2, until the investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death, whichever occurred first
11385013|NCT02288247|EG000|Reported Event|Period 1: Enzalutamide|Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first.
11241341|NCT02486406|OG004|Outcome|Mini-tablet, 3-8 YR, 15 to 29 kg|Participants age 3-8 years old who received the mini-tablet formulation and weighed 15 to 29 kg
11385014|NCT02288247|EG001|Reported Event|Period 2: Enzalutamide|Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB treatment in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385015|NCT02288247|EG002|Reported Event|Period 2: Placebo|Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle= 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first.
11385016|NCT02031978|BG000|Baseline|WIC Participants|Mothers and their child (mother-child dyads)
11385017|NCT02031978|FG000|Participant Flow|WIC Participants|Mothers and their child (mother-child dyads)
11385018|NCT02031978|OG000|Outcome|WIC Participants|Mothers and their child (mother-child dyads)
11385019|NCT02031978|EG000|Reported Event|WIC Participants|Mothers and their child (mother-child dyads)
11385020|NCT01785563|BG000|Baseline|Nasal Non-Invasive NAVA Group|Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
11385021|NCT01785563|FG000|Participant Flow|Nasal Non-Invasive NAVA Group|Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
11385022|NCT01785563|OG000|Outcome|Nasal Non-Invasive NAVA Group|Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
11385023|NCT01785563|EG000|Reported Event|Nasal Non-Invasive NAVA Group|Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
11385024|NCT01732120|BG000|Baseline|Off-clamp Partial Nephrectomy|"Partial nephrectomy will be performed without clamping of the renal blood vessels.~Off-clamp partial nephrectomy"
11385025|NCT01732120|BG001|Baseline|Traditional Partial Nephrectomy|Partial nephrectomy will be performed with clamping of the renal blood vessels.
11385026|NCT01732120|BG002|Baseline|Total|Total of all reporting groups
11385027|NCT01732120|FG000|Participant Flow|Off-clamp Partial Nephrectomy|"Partial nephrectomy will be performed without clamping of the renal blood vessels.~Off-clamp partial nephrectomy"
11385028|NCT01732120|FG001|Participant Flow|Traditional Partial Nephrectomy|Partial nephrectomy will be performed with clamping of the renal blood vessels.
11385029|NCT01732120|OG000|Outcome|Off-clamp Partial Nephrectomy|"Partial nephrectomy will be performed without clamping of the renal blood vessels.~Off-clamp partial nephrectomy"
11385030|NCT01732120|OG001|Outcome|Traditional Partial Nephrectomy|Partial nephrectomy will be performed with clamping of the renal blood vessels.
11385031|NCT01732120|EG000|Reported Event|Off-clamp Partial Nephrectomy|"Partial nephrectomy will be performed without clamping of the renal blood vessels.~Off-clamp partial nephrectomy"
11385032|NCT01732120|EG001|Reported Event|Traditional Partial Nephrectomy|Partial nephrectomy will be performed with clamping of the renal blood vessels.
11385033|NCT01434290|BG000|Baseline|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
11385034|NCT01434290|BG001|Baseline|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
11385035|NCT01434290|BG002|Baseline|Total|Total of all reporting groups
11385036|NCT01434290|FG000|Participant Flow|5 Fractions|36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
11385037|NCT01434290|FG001|Participant Flow|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
11385038|NCT01434290|OG000|Outcome|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
10799926|NCT03135119|EG001|Reported Event|TF-CBT+AAT|"Youth will received Trauma-Focused Cognitive-Behavioral Therapy with Animal-Assisted Therapy as an adjunct.~TF-CBT+AAT: TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions."
11385039|NCT01434290|OG001|Outcome|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
11385040|NCT01434290|OG000|Outcome|5 Fractions|36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
11385041|NCT01434290|EG000|Reported Event|5 Fractions|36.25 Gy IMRT in 5 fractions over two and a half weeks
11385042|NCT01434290|EG001|Reported Event|12 Fractions|51.6 Gy IMRT in 12 fractions over two and a half weeks
11385043|NCT01062399|BG000|Baseline|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385044|NCT01062399|BG001|Baseline|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385045|NCT01062399|BG002|Baseline|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385046|NCT01062399|BG003|Baseline|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
11385047|NCT01062399|BG004|Baseline|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385048|NCT01062399|BG005|Baseline|Total|Total of all reporting groups
11385049|NCT01062399|FG000|Participant Flow|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385050|NCT01062399|FG001|Participant Flow|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385051|NCT01062399|FG002|Participant Flow|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385052|NCT01062399|FG003|Participant Flow|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
11385053|NCT01062399|FG004|Participant Flow|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385054|NCT01062399|OG000|Outcome|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385055|NCT01062399|OG001|Outcome|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385056|NCT01062399|OG002|Outcome|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385057|NCT01062399|OG000|Outcome|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
11385058|NCT01062399|OG001|Outcome|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385059|NCT01062399|EG000|Reported Event|Ph I: RT + TMZ + RAD001 2.5 mg/Day|Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385060|NCT01062399|EG001|Reported Event|Ph I: RT + TMZ + RAD001 5 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385061|NCT01062399|EG002|Reported Event|Ph I: RT + TMZ + RAD001 10 mg/Day|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385062|NCT01062399|EG003|Reported Event|Ph II: RT + TMZ|Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
11385063|NCT01062399|EG004|Reported Event|Ph II: RT + TMZ + RAD001|Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
11385064|NCT00750269|BG000|Baseline|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
11385065|NCT00750269|BG001|Baseline|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
11385066|NCT00750269|BG002|Baseline|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
11385067|NCT00750269|BG003|Baseline|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
11385068|NCT00750269|BG004|Baseline|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
11385069|NCT00750269|BG005|Baseline|Total|Total of all reporting groups
11196710|NCT02166333|FG000|Participant Flow|Randomized to 200 IU/d in Stage 1|These participants received 200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their trial participation; those who continued to Stage 2 (neither completed the trial [completed the 2-year visit], nor died, nor dropped out during Stage 1) continued to receive 200 IU/d cholecalciferol during Stage 2.
11385070|NCT00750269|FG000|Participant Flow|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
11385071|NCT00750269|FG001|Participant Flow|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
11385072|NCT00750269|FG002|Participant Flow|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
11385073|NCT00750269|FG003|Participant Flow|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
11385074|NCT00750269|FG004|Participant Flow|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
11385075|NCT00750269|OG000|Outcome|All Participants|
11385076|NCT00750269|OG000|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
11385077|NCT00750269|OG001|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
11385078|NCT00750269|OG000|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
11385079|NCT00750269|OG001|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
11385080|NCT00750269|OG002|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
11385081|NCT00750269|OG003|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
11385082|NCT00750269|OG004|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
11385083|NCT00750269|OG000|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
11385084|NCT00750269|OG000|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
11385085|NCT00750269|OG001|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
11385086|NCT00750269|OG002|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
11385087|NCT00750269|EG000|Reported Event|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
11385088|NCT00750269|EG001|Reported Event|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
11385089|NCT00750269|EG002|Reported Event|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
11385090|NCT00750269|EG003|Reported Event|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
11385091|NCT00750269|EG004|Reported Event|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
11385092|NCT00712322|BG000|Baseline|Cohort 1 (Darifenacin 0.030 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
11385093|NCT00712322|BG001|Baseline|Cohort 2 (Darifenacin 0.0625 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
11385094|NCT00712322|BG002|Baseline|Cohort 3 (Darifenacin 0.125 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
11385095|NCT00712322|BG003|Baseline|Total|Total of all reporting groups
11385096|NCT00712322|FG000|Participant Flow|Cohort 1 (Darifenacin 0.030 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 milligrams/kilogram/day (mg/kg/day) dispensed per twice a day (BID) dosing, for 14 days.
11385097|NCT00712322|FG001|Participant Flow|Cohort 2 (Darifenacin 0.0625 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
11385098|NCT00712322|FG002|Participant Flow|Cohort 3 (Darifenacin 0.125 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
11385099|NCT00712322|OG000|Outcome|Cohort 1 (Darifenacin 0.030 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
11385100|NCT00712322|OG001|Outcome|Cohort 2 (Darifenacin 0.0625 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
11385101|NCT00712322|OG002|Outcome|Cohort 3 (Darifenacin 0.125 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
11385102|NCT00712322|EG000|Reported Event|Cohort 1 (Darifenacin 0.030 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
11385103|NCT00712322|EG001|Reported Event|Cohort 2 (Darifenacin 0.0625 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
11385104|NCT00712322|EG002|Reported Event|Cohort 3 (Darifenacin 0.125 mg/kg/Day)|Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
11385105|NCT00323856|BG000|Baseline|Alphanate|Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen.
11196711|NCT02166333|FG001|Participant Flow|Additional Participants Randomized to 200 IU/d in Stage 2|These participants began their study participation in Stage 2 and received 200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their participation.
11385106|NCT00323856|FG000|Participant Flow|Alphanate|Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen.
11385107|NCT00323856|OG000|Outcome|Alphanate|Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen.
11385108|NCT00323856|EG000|Reported Event|Alphanate|Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen.
11196712|NCT02166333|FG002|Participant Flow|Randomized to 1000 IU/d in Stage 1|These participants received 1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their trial participation; those who continued to Stage 2 (neither completed the trial [completed the 2-year visit], nor died, nor dropped out during Stage 1) continued to receive 1000 IU/d cholecalciferol during Stage 2.
11196713|NCT02166333|FG003|Participant Flow|Additional Participants Randomized to 1000 IU/d in Stage 2|These participants began their study participation in Stage 2 and received 1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their participation.
11196714|NCT02166333|FG004|Participant Flow|Randomized to 2000 IU/d in Stage 1 and Switched to 1000 IU/d in Stage 2|These participants received 2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually in Stage 1; those who continued to Stage 2 were switched to 1000 IU/d cholecalciferol (vitamin D3) tablets during Stage 2.
11196715|NCT02166333|FG005|Participant Flow|Randomized to 4000 IU/d in Stage 1 and Switched to 1000 IU/d in Stage 2|These participants received 4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually in Stage 1; those who continued to Stage 2 were switched to 1000 IU/d cholecalciferol (vitamin D3) tablets during Stage 2.
11196716|NCT02166333|OG000|Outcome|Experience on Best Dose|The Experience on Best Dose group includes 121 participants randomized to 1000 IU/d during dose-finding and 96 participants randomized to 2000 or 4000 IU/d during dose-finding who were issued at least one bottle of 1000 IU after dose-finding ended, plus 91 participants randomized to 1000 IU/d after dose-finding ended, for a total of 308 participants who had experience on the dose selected as best of the non-control doses for preventing falls. This group excludes 41 participants randomized to 2000 or 4000 IU/d who were never issued a bottle of 1000 IU/d because they completed the trial, died, dropped out, or stopped using study pills without ever being switched to 1000 IU/d.
11196717|NCT02166333|OG001|Outcome|200 IU/d|The 200 IU/d group is the control group and includes participants randomized to 200 IU/d during Stage 1 and participants randomized to 200 IU/d during Stage 2.
11196718|NCT02166333|OG002|Outcome|Pooled Higher Doses|All participants randomized to 1000, 2000, or 4000 IU/d during Stage 1 and all participants randomized to 1000 IU/d during Stage 2.
11196719|NCT02166333|OG000|Outcome|Pooled Higher Doses|The Pooled Higher Doses group includes all participants randomized to 1000, 2000, or 4000 IU/d (n=349).
11196720|NCT02166333|OG001|Outcome|200 IU/Day|The 200 IU/d group is the control group.
11196721|NCT02166333|EG000|Reported Event|Pooled Higher Doses|The Pooled Higher Doses group includes all participants randomized to 1000, 2000, or 4000 IU/d.
11196722|NCT02166333|EG001|Reported Event|200 IU/d|The 200 IU/d group is the control group.
11196723|NCT02166333|EG002|Reported Event|Those With Experience on 1000 IU|This group includes those randomized to 1000 IU and 96 participants randomized to 2000 or 4000 who were issued at least 1 bottle of 1000 IU. Note that participants who switched doses during the trial may have an event while in their original group as well as in the 1000 group if the event recurred after switching to 1000 IU.
11196724|NCT02166333|EG003|Reported Event|Those With Experience on 2000 IU|Only those randomized to 2000 IU are in this group.
11196725|NCT02166333|EG004|Reported Event|Those With Experience on 4000 IU|Only those randomized to 4000 IU are in this group.
10803566|NCT03417245|FG000|Participant Flow|Factor On-demand|Participants received on-demand factor concentrates (as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion for the treatment of breakthrough bleeding episodes from Day 1 up to a total of 9 months.
11196726|NCT02166346|BG000|Baseline|Whole Study Population|This is a crossover trial. At baseline prior to randomization into an intervention, the baseline measures are provided.
11196727|NCT02166346|FG000|Participant Flow|Dalfampridine Then Placebo|"All subjects were randomized for the first double-blinded 8-week part of the study to the dalfampridine group. Then subjects were crossed over to the placebo arm for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
11196728|NCT02166346|FG001|Participant Flow|Placebo Then Dalfampridine|"All subjects were randomized for the first double-blinded 8-week part of the study to the placebo arm. Then subjects were crossed over to the dalfampridine arm for another 8 weeks.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
11196729|NCT02166346|OG000|Outcome|Dalfampridine|"All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
11196730|NCT02166346|OG001|Outcome|Placebo|"Placebo controlled arm.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
11196731|NCT02166346|EG000|Reported Event|Dalfampridine|"All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.~Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks"
11196732|NCT02166346|EG001|Reported Event|Placebo|"Placebo controlled arm.~Placebo: Placebo pill 1 tablet twice daily for 8 weeks"
11196733|NCT02166476|BG000|Baseline|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
11196734|NCT02166476|BG001|Baseline|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
10799927|NCT03128411|BG000|Baseline|Bosutinib|Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
10799928|NCT03128411|FG000|Participant Flow|Bosutinib|Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
11196735|NCT02166476|BG002|Baseline|Total|Total of all reporting groups
11385109|NCT00103038|BG000|Baseline|Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11385110|NCT00103038|FG000|Participant Flow|Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11385111|NCT00103038|OG000|Outcome|Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11385112|NCT00103038|OG000|Outcome|Malignant Brain Tumor Patients Undergoing Brain MRI|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11196736|NCT02166476|FG000|Participant Flow|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
11196737|NCT02166476|FG001|Participant Flow|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
11241342|NCT02486406|OG005|Outcome|Mini-tablet Total|All participants who received the mini-tablet formulation
11241343|NCT02486406|OG000|Outcome|Participants in Parts 1 and 2 of the Study|Participants in Parts 1 and 2 who were part of the ITT population (those who received at least one dose of study drug in Part 1 or Part 2)
11241344|NCT02486406|OG001|Outcome|Adult Tablet, 12-17 YR, ≥ 45 kg|Participants age 12-17 years old who received the adult formulation and weighed ≥ 45 kg
11385113|NCT00103038|OG000|Outcome|Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced MRI|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11385114|NCT00103038|OG001|Outcome|Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI|"Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
11385115|NCT00103038|EG000|Reported Event|Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)|"Study patients: adult patients with high grade primary malignant brain tumors~Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.~3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI~Ferumoxytol: Given IV~Gadolinium: Given IV~MRI-Based Angiogram: Undergo MRA"
10799929|NCT03128411|OG000|Outcome|Bosutinib|Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
10965815|NCT00884117|OG000|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11241345|NCT02486406|OG002|Outcome|Mini-tablet, 9-11 YR, 15 to 29 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed 15 to 29 kg
11241346|NCT02486406|OG003|Outcome|Mini-tablet, 9-11 YR, 30 to 44 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed 30 to 44 kg
11385116|NCT05086835|BG000|Baseline|Stage 1A Intervention Development|Using the NIH Stage Model of Intervention Development, this study will consist of a non-randomized Stage 1A project designed to gather feedback from adults receiving treatments for OUD. This feedback will help our research team finalize a working memory intervention in preparation for a future Stage 1B trial using a randomized design.
11385117|NCT05086835|FG000|Participant Flow|Stage 1A Intervention Development|Adults receiving treatments for OUD. No randomization, and no intervention administered.
11385118|NCT05086835|OG000|Outcome|Working Memory App (Active Intervention)|"A visual-spatial app-based working memory intervention.~Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study."
11385119|NCT05086835|OG001|Outcome|Visual Search App (Control Condition)|"An app-based visual search task to be used as a control condition.~Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study."
11385120|NCT05086835|EG000|Reported Event|Working Memory App (Active Intervention)|"A visual-spatial app-based working memory intervention.~Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study."
11385121|NCT05086835|EG001|Reported Event|Visual Search App (Control Condition)|"An app-based visual search task to be used as a control condition.~Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study."
11385122|NCT05086835|EG002|Reported Event|Stage 1A Intervention Development|Using the NIH Stage Model of Intervention Development, this study will consist of a non-randomized Stage 1A project designed to gather feedback from adults receiving treatments for OUD. This feedback will help our research team finalize a working memory intervention in preparation for a future Stage 1B trial using a randomized design.
11385123|NCT04524663|BG000|Baseline|Camostat Mesilate|Camostat mesilate for 10 days in addition to standard of care treatment.
11385124|NCT04524663|BG001|Baseline|Placebo|Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
11385125|NCT04524663|BG002|Baseline|Total|Total of all reporting groups
11385126|NCT04524663|FG000|Participant Flow|Camostat Mesilate|Camostat mesilate for 10 days in addition to standard of care treatment.
11385127|NCT04524663|FG001|Participant Flow|Placebo|Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
11385128|NCT04524663|OG000|Outcome|Camostat Mesilate|Camostat mesilate for 10 days in addition to standard of care treatment.
11385129|NCT04524663|OG001|Outcome|Placebo|Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
11385130|NCT04524663|EG000|Reported Event|Camostat Mesilate|Camostat mesilate for 10 days in addition to standard of care treatment.
11385131|NCT04524663|EG001|Reported Event|Placebo|Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
11385132|NCT04435795|BG000|Baseline|Ciclesonide Inhaled and Nasal|"Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days~Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber~Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE"
11385133|NCT04435795|BG001|Baseline|Placebo|"Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID~Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID"
10965816|NCT00884117|OG000|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11196738|NCT02166476|OG000|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
11385134|NCT04435795|BG002|Baseline|Total|Total of all reporting groups
11385135|NCT04435795|FG000|Participant Flow|Ciclesonide Inhaled and Nasal|"Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days~Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber~Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE"
11385136|NCT04435795|FG001|Participant Flow|Placebo|"Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID~Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID"
11385137|NCT04435795|OG000|Outcome|Ciclesonide Inhaled and Nasal|"Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days~Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber~Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE"
11385138|NCT04435795|OG001|Outcome|Placebo|"Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID~Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID"
11385139|NCT04435795|EG000|Reported Event|Ciclesonide Inhaled and Nasal|"Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days~Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber~Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE"
11385140|NCT04435795|EG001|Reported Event|Placebo|"Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID~Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID"
11385141|NCT04350593|BG000|Baseline|Dapagliflozin 10mg|"Dapagliflozin 10 mg daily~Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg"
11385142|NCT04350593|BG001|Baseline|Placebo|"Dapagliflozin matching placebo 10 mg daily~Placebo: Placebo Comparator"
11385143|NCT04350593|BG002|Baseline|Total|Total of all reporting groups
11385144|NCT04350593|FG000|Participant Flow|Dapagliflozin 10mg|"Dapagliflozin 10 mg daily~Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg"
11385145|NCT04350593|FG001|Participant Flow|Placebo|"Dapagliflozin matching placebo 10 mg daily~Placebo: Placebo Comparator"
11385146|NCT04350593|OG000|Outcome|Dapagliflozin 10mg|"Dapagliflozin 10 mg daily~Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg"
11385147|NCT04350593|OG001|Outcome|Placebo|"Dapagliflozin matching placebo 10 mg daily~Placebo: Placebo Comparator"
11385148|NCT04350593|EG000|Reported Event|Dapagliflozin 10mg|"Dapagliflozin 10 mg daily~Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg"
11385149|NCT04350593|EG001|Reported Event|Placebo|"Dapagliflozin matching placebo 10 mg daily~Placebo: Placebo Comparator"
10799930|NCT03128411|EG000|Reported Event|Bosutinib|Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
10799931|NCT03097328|BG000|Baseline|TAK228|Subjects will receive treatment with TAK-228 30mg by mouth weekly on day 1, 8, 15 and 22 of a 28-day cycle. Dose can be reduced by the study team. Treatment will continue until disease progression, unaccepted toxicity or other reasons for discontinuation defined by protocol.
10799932|NCT03097328|FG000|Participant Flow|TAK-228|Subjects will receive treatment with TAK-228 30mg by mouth weekly on day 1, 8, 15 and 22 of a 28-day cycle. Dose can be reduced by the study team. Treatment will continue until disease progression, unaccepted toxicity or other reasons for discontinuation defined by protocol.
10799933|NCT03097328|OG000|Outcome|TAK-228|Subjects will receive treatment with TAK-228 30mg by mouth weekly on day 1, 8, 15 and 22 of a 28-day cycle. Dose can be reduced by the study team. Treatment will continue until disease progression, unaccepted toxicity or other reasons for discontinuation defined by protocol.
10799934|NCT03097328|EG000|Reported Event|TAK-228|Subjects will receive treatment with TAK-228 30mg by mouth weekly on day 1, 8, 15 and 22 of a 28-day cycle. Dose can be reduced by the study team. Treatment will continue until disease progression, unaccepted toxicity or other reasons for discontinuation defined by protocol
10799935|NCT03070600|BG000|Baseline|Universal PrEP Counselling|"All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP.~Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown."
10799936|NCT03070600|BG001|Baseline|Targeted PrEP Clinics|"All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling.~Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:~Risk Score >6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors~participant declines partner self-tests regardless of partner HIV status, and/or~their partner declines self-testing or tests positive."
10799937|NCT03070600|BG002|Baseline|Total|Total of all reporting groups
11196739|NCT02166476|OG001|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
11196740|NCT02166476|OG001|Outcome|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after piperacillin-tazobactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
11196741|NCT02166476|OG000|Outcome|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 grams [g] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.
11196742|NCT02166476|OG000|Outcome|Meropenem-Vaborbactam|"Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Treatment was administered for up to 14 days.~AUC0-24 Steady-State estimates not available for 2 participants who received >3 doses."
11196743|NCT02166476|EG000|Reported Event|Meropenem-Vaborbactam|Meropenem-vaborbactam (meropenem 2 g plus vaborbactam 2 g), infused in 250 mL normal saline, administered IV over 3 hours, q8h, with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
10803567|NCT03417245|FG001|Participant Flow|Fitusiran 80 mg Prophylaxis|Participants received open-label fitusiran 80 milligram (mg) administered subcutaneously (SC) as prophylaxis once monthly from Day 1 up to a total of 9 months. Participants received on-demand factor concentrates (per investigator's discretion and within bleeding dosing guidelines) for the treatment of breakthrough bleeding episodes.
10803568|NCT03417245|OG000|Outcome|Factor On-demand|Participants received on-demand factor concentrates (as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion for the treatment of breakthrough bleeding episodes from Day 1 up to a total of 9 months.
11241347|NCT02486406|OG004|Outcome|Mini-tablet, 9-11 YR, ≥ 45 kg|Participants age 9-11 years old who received the mini-tablet formulation and weighed ≥ 45 kg
11196744|NCT02166476|EG001|Reported Event|Piperacillin-Tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
11241348|NCT02486406|OG005|Outcome|Mini-tablet, 3-8 YR, 15 to 29 kg|Participants age 3-8 years old who received the mini-tablet formulation and weighed 15 to 29 kg
11241349|NCT02486406|OG006|Outcome|Mini-tablet Total|All participants who received the mini-tablet formulation
11385150|NCT04208243|BG000|Baseline|Oncology Patient|"Any Oncology patient in the CCBD who has not previously received more than two sessions of CAT in the outpatient unit and who will be receiving approximately weekly infusions of at least one hour in the infusion center will be identified by a research assistant.~Creative Arts Therapy: The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The dose of CAT will be recorded (number and type of sessions) and will be factored into the analysis."
11385151|NCT04208243|FG000|Participant Flow|Oncology Patient|"Any Oncology patient in the CCBD who has not previously received more than two sessions of CAT in the outpatient unit and who will be receiving approximately weekly infusions of at least one hour in the infusion center will be identified by a research assistant.~Creative Arts Therapy: The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The dose of CAT will be recorded (number and type of sessions) and will be factored into the analysis."
11385152|NCT04208243|OG000|Outcome|Oncology Patient|"Any Oncology patient in the CCBD who has not previously received more than two sessions of CAT in the outpatient unit and who will be receiving approximately weekly infusions of at least one hour in the infusion center will be identified by a research assistant.~Creative Arts Therapy: The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The dose of CAT will be recorded (number and type of sessions) and will be factored into the analysis."
11385153|NCT04208243|EG000|Reported Event|Oncology Patient|"Any Oncology patient in the CCBD who has not previously received more than two sessions of CAT in the outpatient unit and who will be receiving approximately weekly infusions of at least one hour in the infusion center will be identified by a research assistant.~Creative Arts Therapy: The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The dose of CAT will be recorded (number and type of sessions) and will be factored into the analysis."
11385154|NCT04067518|BG000|Baseline|Part 1: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4) in the 5-week tolerability assessment period, Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385155|NCT04067518|BG001|Baseline|Part 2: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385156|NCT04067518|BG002|Baseline|Total|Total of all reporting groups
11241350|NCT02486406|OG000|Outcome|Adult Tablet,12-17 YR, ≥ 45 kg, ALT Normalization|Participants age 12-17 years old with alanine aminotransferase > upper limit of normal at baseline who received the adult formulation and weighed ≥ 45 kg
11385157|NCT04067518|FG000|Participant Flow|Part 1: SHP674|Participants with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674, 2500 international units per square meter (IU/m^2) (if body surface area [BSA] ≥0.6 m^2) or 82.5 international units per kilogram (IU/kg) (if BSA <0.6 m^2) intravenously (IV) on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period and who were stratified into the high risk (HR) group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4) in the 5-week tolerability assessment period, Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385158|NCT04067518|FG001|Participant Flow|Part 2: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385159|NCT04067518|OG000|Outcome|Part 1: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4) in the 5-week tolerability assessment period, Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385160|NCT04067518|OG000|Outcome|Part 2: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385161|NCT04067518|OG001|Outcome|Part 2: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385162|NCT04067518|EG000|Reported Event|Part 1: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4) in the 5-week tolerability assessment period, Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385163|NCT04067518|EG001|Reported Event|Part 2: SHP674|Participants with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
11385164|NCT03866473|BG000|Baseline|Photobiomodulation (PBM)|"670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).~Retilux: 670nm wavelength light"
11385165|NCT03866473|BG001|Baseline|Placebo|"Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)~Sham Light Device: Broad spectrum light device"
11385166|NCT03866473|BG002|Baseline|Total|Total of all reporting groups
11385167|NCT03866473|FG000|Participant Flow|Photobiomodulation (PBM) Intervention|"670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).~Retilux: 670nm wavelength light"
10799938|NCT03070600|FG000|Participant Flow|Universal PrEP Counselling|"All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP.~Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown."
10799939|NCT03070600|FG001|Participant Flow|Targeted PrEP Clinics|"All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling.~Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:~Risk Score >6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors~participant declines partner self-tests regardless of partner HIV status, and/or~their partner declines self-testing or tests positive."
10799940|NCT03070600|OG000|Outcome|Universal PrEP Counselling|"All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP.~Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown."
10799941|NCT03070600|OG001|Outcome|Targeted PrEP Clinics|"All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling.~Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:~Risk Score >6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors~participant declines partner self-tests regardless of partner HIV status, and/or~their partner declines self-testing or tests positive."
10799942|NCT03070600|OG000|Outcome|Universal Arm- PrEP Initiated|Participants in the Universal Arm that initiated PrEP at any point during the study
10799943|NCT03070600|OG001|Outcome|Targeted Arm- PrEP Initiated|Participants in the Targeted Arm that initiated PrEP at any point during the study period
10799944|NCT03070600|OG000|Outcome|Universal Arm- PrEP Initiated|This analysis is restricted to participants who initiated PrEP during the study period.
11196745|NCT02166606|BG000|Baseline|Pacemaker/Lead Implant|"All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an all-comers consecutive basis.~ImageReady MR Conditional Pacing System Implant: Implant according to standard-of-care.~No study-specific interventions in that registry."
10799945|NCT03070600|OG001|Outcome|Targeted Arm- PrEP Initiated|This analysis is restricted to participants who initiated PrEP during the study period.
10799946|NCT03070600|EG000|Reported Event|Universal PrEP Counselling|"All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP.~Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown."
10799947|NCT03070600|EG001|Reported Event|Targeted PrEP Clinics|"All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling.~Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:~Risk Score >6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors~participant declines partner self-tests regardless of partner HIV status, and/or~their partner declines self-testing or tests positive."
10803569|NCT03417245|OG001|Outcome|Fitusiran 80 mg Prophylaxis|Participants received open-label fitusiran 80 milligram (mg) administered subcutaneously (SC) as prophylaxis once monthly from Day 1 up to a total of 9 months. Participants received on-demand factor concentrates (per investigator's discretion and within bleeding dosing guidelines) for the treatment of breakthrough bleeding episodes.
10799948|NCT03068715|BG000|Baseline|Active TBS-DLPFC|"The active group will receive theta-burst TMS stimulation.~Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator."
10799949|NCT03068715|BG001|Baseline|Sham TBS-DLPFC|"The sham group will receive sham theta-burst TMS stimulation.~Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion."
10799950|NCT03068715|BG002|Baseline|Total|Total of all reporting groups
10799951|NCT03068715|FG000|Participant Flow|Active TBS-DLPFC|"The active group will receive theta-burst TMS stimulation.~Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator.~Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
10799952|NCT03068715|FG001|Participant Flow|Sham TBS-DLPFC|"The sham group will receive sham theta-burst TMS stimulation.~Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.~Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
10799953|NCT03068715|OG000|Outcome|Active TBS-DLPFC|"The active group will receive theta-burst TMS stimulation.~Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator."
10799954|NCT03068715|OG001|Outcome|Sham TBS-DLPFC|"The sham group will receive sham theta-burst TMS stimulation.~Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion."
10799955|NCT03068715|OG000|Outcome|Active TBS-DLPFC|"The active group will receive theta-burst TMS stimulation.~Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator.~Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
11385168|NCT03866473|FG001|Participant Flow|Placebo Intervention|"Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)~Sham Light Device: Broad spectrum light device"
11385169|NCT03866473|OG000|Outcome|Photobiomodulation (PBM)|"670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).~Retilux: 670nm wavelength light"
10799956|NCT03068715|OG001|Outcome|Sham TBS-DLPFC|"The sham group will receive sham theta-burst TMS stimulation.~Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.~Open label TBS-DLPFC: All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
10799957|NCT03068715|EG000|Reported Event|Active TBS-DLPFC|"The active group will receive theta-burst TMS stimulation.~Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator."
10799958|NCT03068715|EG001|Reported Event|Sham TBS-DLPFC|"The sham group will receive sham theta-burst TMS stimulation.~Sham TBS-DLPFC: The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion."
11196746|NCT02166606|FG000|Participant Flow|Pacemaker/Lead Implant|"All enrolled subjects received an ImageReady Magnet Resonant (MR) Conditional Pacing System according to standard-of-care. No study-specific interventions were performed in the registry. The treatment assignment was based on an all-comers consecutive basis."
10803570|NCT03417245|EG000|Reported Event|Factor On-demand|Participants received on-demand factor concentrates (as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion for the treatment of breakthrough bleeding episodes from Day 1 up to a total of 9 months.
11385170|NCT03866473|OG001|Outcome|Placebo|"Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)~Sham Light Device: Broad spectrum light device"
11196747|NCT02166606|OG000|Outcome|Pacemaker/Lead Implant|All enrolled subjects successfully implanted with a complete ImageReady™ System.
11196748|NCT02166606|EG000|Reported Event|Pacemaker/Lead Implant|All enrolled subjects successfully implanted with a complete ImageReady™ System.
11385171|NCT03866473|OG000|Outcome|Phase 2 Photobiomodulation (PBM)|"670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).~Retilux: 670nm wavelength light"
11385172|NCT03866473|OG001|Outcome|Phase 2 Placebo|"Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)~Sham Light Device: Broad spectrum light device"
11385173|NCT03866473|EG000|Reported Event|Phase 1 Photobiomodulation (PBM) Intervention|670nm wavelength device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device).
11385174|NCT03866473|EG001|Reported Event|Phase 1 Placebo Intervention|Broad spectrum light device twice a day for 90 seconds through 4 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
11385175|NCT03866473|EG002|Reported Event|Phase 2 Photobiomodulation (PBM) Intervention|670nm wavelength device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
11385176|NCT03866473|EG003|Reported Event|Phase 2 Placebo Intervention|Broad spectrum light device twice a day for 90 seconds 4 to 8 months. At the 4-month visit, participants who have not already received alternative treatments for DME will return the original device and receive the alternative treatment group device (i.e. the sham group will receive an active treatment device and the active treatment group will receive a sham device)
11385177|NCT03738423|BG000|Baseline|Placebo Q2W|Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385178|NCT03738423|BG001|Baseline|REGN3500 30 mg Q8W|Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385179|NCT03738423|BG002|Baseline|REGN3500 100 mg Q4W|Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385180|NCT03738423|BG003|Baseline|REGN3500 300 mg Q4W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385181|NCT03738423|BG004|Baseline|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
11385182|NCT03738423|BG005|Baseline|Total|Total of all reporting groups
11385183|NCT03738423|FG000|Participant Flow|Placebo Q2W|Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385184|NCT03738423|FG001|Participant Flow|REGN3500 30 mg Q8W|Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385185|NCT03738423|FG002|Participant Flow|REGN3500 100 mg Q4W|Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385186|NCT03738423|FG003|Participant Flow|REGN3500 300 mg Q4W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11196749|NCT02166697|BG000|Baseline|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
11196750|NCT02166697|FG000|Participant Flow|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
11196751|NCT02166697|OG000|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
11196752|NCT02166697|EG000|Reported Event|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
11196753|NCT02167035|BG000|Baseline|Combigan Twice Daily (BID)|"Combigan 0.2%/0.5% one drop Twice Daily (BID)~Combigan Twice Daily (BID)"
11196754|NCT02167035|BG001|Baseline|Simbrinza Three Times Daily (TID)|"Simbrinza 1/0.2% one drop Three Times Daily (TID)~Simbrinza Three Times Daily (TID)"
11196755|NCT02167035|BG002|Baseline|Total|Total of all reporting groups
11196756|NCT02167035|FG000|Participant Flow|Combigan Two Times Daily (BID)|"Combigan 0.2%/0.5% one drop Two Times Daily (BID)~Combigan Two Times Daily (BID)"
11196757|NCT02167035|FG001|Participant Flow|Simbrinza Three Times Daily (TID)|"Simbrinza 1/0.2% one drop Three Times Daily (TID)~Simbrinza Three Times Daily (TID)"
10799959|NCT02981472|BG000|Baseline|Apixaban|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.~Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID)."
10799960|NCT02981472|BG001|Baseline|Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)|"Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH."
10799961|NCT02981472|BG002|Baseline|Total|Total of all reporting groups
10799962|NCT02981472|FG000|Participant Flow|Apixaban|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.~Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID)."
10799963|NCT02981472|FG001|Participant Flow|Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)|"Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH."
10799964|NCT02981472|OG000|Outcome|Apixaban|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.~Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID)."
10799965|NCT02981472|OG001|Outcome|Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)|"Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH."
10799966|NCT02981472|OG000|Outcome|Participants Weight Range 6 to < 9 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between 6 to < 9 kg will be administered 1mg apixaban twice daily (BID)."
11385187|NCT03738423|FG004|Participant Flow|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
11385188|NCT03738423|OG000|Outcome|Placebo Q2W|Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385189|NCT03738423|OG001|Outcome|REGN3500 30 mg Q8W|Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385190|NCT03738423|OG002|Outcome|REGN3500 100 mg Q4W|Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385191|NCT03738423|OG003|Outcome|REGN3500 300 mg Q4W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385192|NCT03738423|OG004|Outcome|REGN3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
11385193|NCT03738423|EG000|Reported Event|Placebo Q2W|Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385194|NCT03738423|EG001|Reported Event|R3500 30 mg Q8W|Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
11385195|NCT03738423|EG002|Reported Event|R3500 100 mg Q4W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385196|NCT03738423|EG003|Reported Event|R3500 300 mg Q4W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14.
11385197|NCT03738423|EG004|Reported Event|R3500 300 mg Q2W|Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14.
10799967|NCT02981472|OG001|Outcome|Participants Weight Range 9 to < 12 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between 9 to < 12 kg will be administered 1.5mg apixaban twice daily (BID)."
10799968|NCT02981472|OG002|Outcome|Participants Weight Range 12 to < 18 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between 12 to < 18 kg will be administered 2mg apixaban twice daily (BID)."
11385198|NCT03600818|BG000|Baseline|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
11385199|NCT03600818|BG001|Baseline|Sarilumab 200mg q2w+14 Week Taper|Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
11385200|NCT03600818|BG002|Baseline|Total Title|
11385201|NCT03600818|FG000|Participant Flow|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
11385202|NCT03600818|FG001|Participant Flow|Sarilumab 200mg q2w+14 Week Taper|Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
11385203|NCT03600818|OG000|Outcome|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
11385204|NCT03600818|OG001|Outcome|Sarilumab 200mg q2w+14 Week Taper|Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
11385205|NCT03600818|OG000|Outcome|Sarilumab 200mg q2w+14 Week Taper|Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
11385206|NCT03600818|EG000|Reported Event|Placebo+52 Week Taper|Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
11385207|NCT03600818|EG001|Reported Event|Sarilumab 200mg q2w+14 Week Taper|Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
11196758|NCT02167035|OG000|Outcome|Combigan BID|"Combigan 0.2%/0.5% one drop Twice Daily (BID)~Combigan Twice Daily (BID)"
11196759|NCT02167035|OG001|Outcome|Simbrinza TID|"Simbrinza 1/0.2% one drop Three Times Daily (TID)~Simbrinza Three Times Daily (TID)"
11196760|NCT02167035|OG000|Outcome|Combigan BID|"Combigan 0.2%/0.5% one drop BID~Combigan BID"
11196761|NCT02167035|OG001|Outcome|Simbrinza TID|"Simbrinza 1/0.2% one drop TID~Simbrinza TID"
11385208|NCT03578276|BG000|Baseline|LessDrops|"Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.~Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%"
11385209|NCT03578276|BG001|Baseline|Standard of Care|"Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.~Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory~Gatifloxacin Ophthalmic: Antibiotic~Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory"
11385210|NCT03578276|BG002|Baseline|Total|Total of all reporting groups
11385211|NCT03578276|FG000|Participant Flow|LessDrops|"Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.~Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%"
11385212|NCT03578276|FG001|Participant Flow|Standard of Care|"Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.~Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory~Gatifloxacin Ophthalmic: Antibiotic~Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory"
11385213|NCT03578276|OG000|Outcome|LessDrops|"Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.~Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%"
11385214|NCT03578276|OG001|Outcome|Standard of Care|"Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.~Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory~Gatifloxacin Ophthalmic: Antibiotic~Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory"
11385215|NCT03578276|EG000|Reported Event|LessDrops|"Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.~Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%"
11385216|NCT03578276|EG001|Reported Event|Standard of Care|"Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.~Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory~Gatifloxacin Ophthalmic: Antibiotic~Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory"
11385217|NCT03257696|BG000|Baseline|Reliable|Patients who respond reliably to closed questions, according to the speech therapist classification
11385218|NCT03257696|BG001|Baseline|Unreliable|Patients who do not respond reliably to closed questions, according to the speech therapist classification
11385219|NCT03257696|BG002|Baseline|Total|Total of all reporting groups
11385220|NCT03257696|FG000|Participant Flow|Reliable|Patients who respond reliably to closed questions, according to the speech therapist classification
11196762|NCT02167035|EG000|Reported Event|Combigan BID|"Combigan 0.2%/0.5% one drop BID~Combigan BID"
11385221|NCT03257696|FG001|Participant Flow|Unreliable|Patients who do not respond reliably to closed questions, according to the speech therapist classification
11385222|NCT03257696|OG000|Outcome|Reliable|Patients who respond reliably to closed questions, according to the speech therapist classification
11385223|NCT03257696|OG001|Outcome|Unreliable|Patients who do not respond reliably to closed questions, according to the speech therapist classification
11385224|NCT03257696|EG000|Reported Event|Reliable|Patients who respond reliably to closed questions, according to the speech therapist classification
11385225|NCT03257696|EG001|Reported Event|Unreliable|Patients who do not respond reliably to closed questions, according to the speech therapist classification
11385226|NCT03035409|BG000|Baseline|Anamorelin|Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
11385227|NCT03035409|FG000|Participant Flow|Anamorelin|Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
11385228|NCT03035409|OG000|Outcome|Anamorelin|Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
11385229|NCT03035409|EG000|Reported Event|Anamorelin|Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
11385230|NCT02971761|BG000|Baseline|Treatment (Pembrolizumab, Enobosarm)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~Enobosarm: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11385231|NCT02971761|FG000|Participant Flow|Treatment (Pembrolizumab, Enobosarm)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~Enobosarm: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11385232|NCT02971761|OG000|Outcome|Treatment (Pembrolizumab, Enobosarm)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~Enobosarm: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11385233|NCT02971761|EG000|Reported Event|Treatment (Pembrolizumab, Enobosarm)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~Enobosarm: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11385234|NCT02900560|BG000|Baseline|Cohort 1|"CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385235|NCT02900560|BG001|Baseline|Cohort 2|"CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385236|NCT02900560|BG002|Baseline|Cohort 3|"CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385237|NCT02900560|BG003|Baseline|Cohort 4|"CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385238|NCT02900560|BG004|Baseline|Total|Total of all reporting groups
11385239|NCT02900560|FG000|Participant Flow|Cohort 1|"CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385240|NCT02900560|FG001|Participant Flow|Cohort 2|"CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385241|NCT02900560|FG002|Participant Flow|Cohort 3|"CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385242|NCT02900560|FG003|Participant Flow|Cohort 4|"CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385243|NCT02900560|OG000|Outcome|Cohort 1|"CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
10799969|NCT02981472|OG003|Outcome|Participants Weight Range 18 to < 25 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between 18 to < 25 kg will be administered 3mg apixaban twice daily (BID)."
11196763|NCT02167035|EG001|Reported Event|Simbrinza TID|"Simbrinza 1/0.2% one drop TID~Simbrinza TID"
11196764|NCT02167074|BG000|Baseline|25G FNA Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~25G FNA needle"
11196765|NCT02167074|BG001|Baseline|20G ProCore FNB Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~20G ProCore FNB needle"
11196766|NCT02167074|BG002|Baseline|Total|Total of all reporting groups
11385244|NCT02900560|OG001|Outcome|Cohort 2|"CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11196767|NCT02167074|FG000|Participant Flow|25G FNA Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~25G FNA needle"
11196768|NCT02167074|FG001|Participant Flow|20G ProCore FNB Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~20G ProCore FNB needle"
11196769|NCT02167074|OG000|Outcome|25G FNA Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~25G FNA needle"
11196770|NCT02167074|OG001|Outcome|20G ProCore FNB Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~20G ProCore FNB needle"
11385245|NCT02900560|OG002|Outcome|Cohort 3|"CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385246|NCT02900560|OG003|Outcome|Cohort 4|"CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385247|NCT02900560|EG000|Reported Event|Cohort 1|"CC-486 100 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385248|NCT02900560|EG001|Reported Event|Cohort 2|"CC-486 100 mg twice a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385249|NCT02900560|EG002|Reported Event|Cohort 3|"CC-486 300 mg once a day, 14 days on and 14 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385250|NCT02900560|EG003|Reported Event|Cohort 4|"CC-486 300 mg once a day, 21 days on, 7 days off combined with Pembrolizumab 200 mg IV every 21 days~CC-486: CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet~Pembrolizumab: Pembrolizumab 200 mg IV every 21 days"
11385251|NCT02366403|BG000|Baseline|Sudarshan Kriya Yoga|"a standardized meditation program~SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment."
11385252|NCT02366403|BG001|Baseline|CPT-C|"CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.~CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques."
11385253|NCT02366403|BG002|Baseline|Total|Total of all reporting groups
11385254|NCT02366403|FG000|Participant Flow|Sudarshan Kriya Yoga|"a standardized meditation program~SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment."
11385255|NCT02366403|FG001|Participant Flow|CPT-C|"CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.~CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques."
11385256|NCT02366403|OG000|Outcome|Sudarshan Kriya Yoga|"a standardized meditation program~SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment."
11385257|NCT02366403|OG001|Outcome|CPT-C|"CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.~CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques."
11385258|NCT02366403|EG000|Reported Event|Sudarshan Kriya Yoga|"a standardized meditation program~SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment."
11385259|NCT02366403|EG001|Reported Event|CPT-C|"CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.~CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques."
11385260|NCT02220894|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
11385261|NCT02220894|BG001|Baseline|Chemotherapy (SOC Treatment)|Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11385262|NCT02220894|BG002|Baseline|Total|Total of all reporting groups
11385263|NCT02220894|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles)
11196771|NCT02167074|EG000|Reported Event|25G FNA Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~25G FNA needle"
11385264|NCT02220894|FG001|Participant Flow|Chemotherapy (Standard of Care [SOC] Treatment)|Participants received carboplatin at target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11385265|NCT02220894|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
11385266|NCT02220894|OG001|Outcome|Chemotherapy (SOC Treatment)|Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11385267|NCT02220894|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
11385268|NCT02220894|EG001|Reported Event|Chemotherapy (SOC Treatment)|Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m^2 by IV infusion on Day 1 Q3W
11385269|NCT02112526|BG000|Baseline|Cohort 1 - Relapse Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11385270|NCT02112526|BG001|Baseline|Cohort 2 - Refractory Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11196772|NCT02167074|EG001|Reported Event|20G ProCore FNB Needle|"Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).~20G ProCore FNB needle"
11385271|NCT02112526|BG002|Baseline|Total|Total of all reporting groups
11385272|NCT02112526|FG000|Participant Flow|Cohort 1 - Relapse Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11241351|NCT02486406|OG001|Outcome|Mini-tablet, 9-11 YR, 15 to 29 kg, ALT Normalization|Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg
11385273|NCT02112526|FG001|Participant Flow|Cohort 2 - Refractory Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11385274|NCT02112526|OG000|Outcome|Cohort 1 - Relapse Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11385275|NCT02112526|OG001|Outcome|Cohort 2 - Refractory Subjects|Acalabrutinib 100mg administered orally (PO) twice daily (BID)
11385276|NCT02112526|EG000|Reported Event|Cohort 1 - Relapse Subjects|Acalabrutinib 100mg administered orally (PO) twice daily
11241352|NCT02486406|OG002|Outcome|Mini-tablet, 9-11 YR, 30 to 44 kg, ALT Normalization|Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 30 to 44 kg
11241353|NCT02486406|OG003|Outcome|Mini-tablet, 3-8 YR, 15 to 29 kg, ALT Normalization|Participants age 3-8 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg
11385277|NCT02112526|EG001|Reported Event|Cohort 2 - Refractory Subjects|Acalabrutinib 100mg administered orally (PO) twice daily
11385278|NCT01968213|BG000|Baseline|Rucaparib 600 mg Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385279|NCT01968213|BG001|Baseline|Placebo Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385280|NCT01968213|BG002|Baseline|Total|Total of all reporting groups
11385281|NCT01968213|FG000|Participant Flow|Rucaparib 600 mg Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385282|NCT01968213|FG001|Participant Flow|Placebo Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385283|NCT01968213|OG000|Outcome|Rucaparib 600 mg Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385284|NCT01968213|OG001|Outcome|Placebo Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385285|NCT01968213|EG000|Reported Event|Rucaparib 600 mg Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385286|NCT01968213|EG001|Reported Event|Placebo Tablets|Taken orally twice daily (continuous 28 day treatment cycles)
11385287|NCT01843374|BG000|Baseline|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
11385288|NCT01843374|BG001|Baseline|PLACEBO|Placebo.
11385289|NCT01843374|BG002|Baseline|Total|Total of all reporting groups
11385290|NCT01843374|FG000|Participant Flow|PLACEBO|Placebo.
11385291|NCT01843374|FG001|Participant Flow|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
11385292|NCT01843374|OG000|Outcome|PLACEBO|Placebo.
11385293|NCT01843374|OG001|Outcome|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
11385294|NCT01843374|OG000|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
11385295|NCT01843374|OG001|Outcome|PLACEBO|Placebo.
11385296|NCT01843374|OG001|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
11385297|NCT01843374|EG000|Reported Event|PLACEBO|Placebo.
11385298|NCT01843374|EG001|Reported Event|TREMELIMUMAB|Tremelimumab 10mg/kg
11385299|NCT01656486|BG000|Baseline|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
11385300|NCT01656486|FG000|Participant Flow|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
11385301|NCT01656486|OG000|Outcome|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
11385302|NCT01656486|EG000|Reported Event|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
11385303|NCT01627574|BG000|Baseline|Motivational Intervention|"There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up."
11385304|NCT01627574|BG001|Baseline|Didactic Educational Intervention|"There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up."
11385305|NCT01627574|BG002|Baseline|Total|Total of all reporting groups
11385306|NCT01627574|FG000|Participant Flow|Motivational Intervention|"There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up."
11385307|NCT01627574|FG001|Participant Flow|Didactic Educational Intervention|"There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up."
11385308|NCT01627574|OG000|Outcome|Motivational Intervention|"There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up."
11241354|NCT02486406|OG004|Outcome|Mini-tablet Total, ALT Normalization|All participants with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation
11385309|NCT01627574|OG001|Outcome|Didactic Educational Intervention|"There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up."
11385310|NCT01627574|EG000|Reported Event|Motivational Intervention|"There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up."
11385311|NCT01627574|EG001|Reported Event|Didactic Educational Intervention|"There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.~Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up."
11385312|NCT01498458|BG000|Baseline|Pazopanib Plus Capecitabine|pazopanib plus capecitabine
11385313|NCT01498458|FG000|Participant Flow|Pazopanib Plus Capecitabine|The baseline refers only to the 8 patients who received Pazopanib.
11385314|NCT01498458|OG000|Outcome|Pazopanib Plus Capecitabine|A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
11385315|NCT01498458|OG000|Outcome|Pazopanib Plus Capecitabine|The following DLTs resulted in permanent discontinuation of the study therapy: hypertension, (DLT 1), mucositis CTC grade 3, hand-foot-syndrome CTC grade 3, increase of liver enzymes (GOT,- and GPT) CTC grade 2 (DLT 2), and increase of liver enzymes (GOT-, GPT) CTC grade 3 (DLT 3).
11385316|NCT01498458|OG000|Outcome|Pazopanib + Capecitabine|Pazopanib and Capecitabine
11385317|NCT01498458|OG000|Outcome|Pazopanib Plus Capecitabine|pazopanib together with capecitabine
11385318|NCT01498458|OG000|Outcome|Pazopanib Plus Capecitabine|
11385319|NCT01498458|OG000|Outcome|Pazopanib Plus Capecitabine|2 patients were on study treatment for a long time.
11385320|NCT01498458|EG000|Reported Event|Pazopanib Plus Capecitabine|There was only one arm in this study as this was a dose escalation study.
11241355|NCT02486406|OG005|Outcome|Participants in Parts 1 and 2 of the Study, ALT Normalization|All participants with alanine aminotransferase > upper limit of normal at baseline
11385321|NCT01427712|BG000|Baseline|LipaCreon|"In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.~Also, the dose was adjusted appropriately according to the patient's condition.~Pancrelipase"
11385322|NCT01427712|FG000|Participant Flow|LipaCreon|"In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.~Also, the dose was adjusted appropriately according to the patient's condition.~Pancrelipase"
11385323|NCT01427712|OG000|Outcome|LipaCreon|"In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.~Also, the dose was adjusted appropriately according to the patient's condition.~Pancrelipase"
11385324|NCT01427712|EG000|Reported Event|LipaCreon|"In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.~Also, the dose was adjusted appropriately according to the patient's condition.~Pancrelipase"
11385325|NCT01369147|BG000|Baseline|Parenteral Nutrition Energy Dose at 0.6 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385326|NCT01369147|BG001|Baseline|Parenteral Nutrition Energy Dose at 1.0 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385327|NCT01369147|BG002|Baseline|Parenteral Nutrition Energy Dose at 1.3 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385328|NCT01369147|BG003|Baseline|Total|Total of all reporting groups
11385329|NCT01369147|FG000|Participant Flow|Parenteral Nutrition Energy Dose at 0.6 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x resting energy expenditure (REE) for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385330|NCT01369147|FG001|Participant Flow|Parenteral Nutrition Energy Dose at 1.0 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385331|NCT01369147|FG002|Participant Flow|Parenteral Nutrition Energy Dose at 1.3 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385332|NCT01369147|OG000|Outcome|Parenteral Nutrition Energy Dose at 0.6 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385333|NCT01369147|OG001|Outcome|Parenteral Nutrition Energy Dose at 1.0 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385334|NCT01369147|OG002|Outcome|Parenteral Nutrition Energy Dose at 1.3 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385335|NCT01369147|EG000|Reported Event|Parenteral Nutrition Energy Dose at 0.6 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385336|NCT01369147|EG001|Reported Event|Parenteral Nutrition Energy Dose at 1.0 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385337|NCT01369147|EG002|Reported Event|Parenteral Nutrition Energy Dose at 1.3 x Measured REE|Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
11385338|NCT01097746|BG000|Baseline|Treatment (Paclitaxel, Carboplatin, Bevacizumab)|Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11196773|NCT02167139|BG000|Baseline|SB5 (Proposed Biosimilar to Adalimumab)|"SB5 40 mg every other week via subcutaneous injection~SB5 (proposed biosimilar to adalimumab)"
11196774|NCT02167139|BG001|Baseline|Humira (Adalimumab)|"Humira 40 mg every other week via subcutaneous injection~Humira (adalimumab)~SB5 (proposed biosimilar to adalimumab)"
11196775|NCT02167139|BG002|Baseline|Total|Total of all reporting groups
11196776|NCT02167139|FG000|Participant Flow|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
11196777|NCT02167139|FG001|Participant Flow|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11385339|NCT01097746|FG000|Participant Flow|Treatment (Paclitaxel, Carboplatin, Bevacizumab)|Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11385340|NCT01097746|OG000|Outcome|Treatment (Paclitaxel, Carboplatin, Bevacizumab)|Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11385341|NCT01097746|EG000|Reported Event|Treatment (Paclitaxel, Carboplatin, Bevacizumab)|Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
11385342|NCT01079780|BG000|Baseline|Arm A (IC)|Patients receive cetuximab (500 mg/m^2) intravenously (IV) over 60-120 minutes and irinotecan hydrochloride (180 mg/m^2) over 60-90 minutes on day 1. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11196778|NCT02167139|FG002|Participant Flow|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11196779|NCT02167139|FG003|Participant Flow|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
11385343|NCT01079780|BG001|Baseline|Arm B (ICR)|Patients receive ramucirumab (8 mg/kg) IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385344|NCT01079780|BG002|Baseline|Arm C (mICR)|Patients receive reduced dose of ramucirumab (6 mg/kg) IV over 60 minutes on day 1 and cetuximab (150 mg/m^2) and irinotecan hydrochloride (400 mg/m^2) as in arm B. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385345|NCT01079780|BG003|Baseline|Total|Total of all reporting groups
11385346|NCT01079780|FG000|Participant Flow|Arm A (IC)|Patients receive cetuximab (500 mg/m^2) intravenously (IV) over 60-120 minutes and irinotecan hydrochloride (180 mg/m^2) over 60-90 minutes on day 1. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385347|NCT01079780|FG001|Participant Flow|Arm B (ICR)|Patients receive ramucirumab (8 mg/kg) IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385348|NCT01079780|FG002|Participant Flow|Arm C (mICR)|Patients receive reduced dose of ramucirumab (6 mg/kg) IV over 60 minutes on day 1 and cetuximab (150 mg/m^2) and irinotecan hydrochloride (400 mg/m^2) as in arm B. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385349|NCT01079780|OG000|Outcome|Arm A (IC)|Patients receive cetuximab (500 mg/m^2) intravenously (IV) over 60-120 minutes and irinotecan hydrochloride (180 mg/m^2) over 60-90 minutes on day 1. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385350|NCT01079780|OG001|Outcome|Arm B (ICR)|Patients receive ramucirumab (8 mg/kg) IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385351|NCT01079780|OG002|Outcome|Arm C (mICR)|Patients receive reduced dose of ramucirumab (6 mg/kg) IV over 60 minutes on day 1 and cetuximab (150 mg/m^2) and irinotecan hydrochloride (400 mg/m^2) as in arm B. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385352|NCT01079780|EG000|Reported Event|Arm A (IC)|Patients receive cetuximab (500 mg/m^2) intravenously (IV) over 60-120 minutes and irinotecan hydrochloride (180 mg/m^2) over 60-90 minutes on day 1. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385353|NCT01079780|EG001|Reported Event|Arm B (ICR)|Patients receive ramucirumab (8 mg/kg) IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385354|NCT01079780|EG002|Reported Event|Arm C (mICR)|Patients receive reduced dose of ramucirumab (6 mg/kg) IV over 60 minutes on day 1 and cetuximab (150 mg/m^2) and irinotecan hydrochloride (400 mg/m^2) as in arm B. Treatment repeats every 2 weeks until disease progression or unacceptable toxicities.
11385355|NCT00075946|BG000|Baseline|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11385356|NCT00075946|BG001|Baseline|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385357|NCT00075946|BG002|Baseline|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11196780|NCT02167139|OG000|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection up to Week 24
11196781|NCT02167139|OG001|Outcome|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection up to Week 24
11196782|NCT02167139|OG000|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
11196783|NCT02167139|OG001|Outcome|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11196784|NCT02167139|OG002|Outcome|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
11196785|NCT02167139|OG000|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 24|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
11385358|NCT00075946|BG003|Baseline|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385359|NCT00075946|BG004|Baseline|Total|Total of all reporting groups
11385360|NCT00075946|FG000|Participant Flow|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11385361|NCT00075946|FG001|Participant Flow|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385362|NCT00075946|FG002|Participant Flow|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11385363|NCT00075946|FG003|Participant Flow|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385364|NCT00075946|FG004|Participant Flow|Enrolled But Not Randomized|Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
11385365|NCT00075946|OG000|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11385366|NCT00075946|OG001|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385367|NCT00075946|OG002|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
11385368|NCT00075946|OG003|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
11385369|NCT00075946|OG000|Outcome|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
11385370|NCT00075946|OG001|Outcome|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
11385371|NCT00075946|EG000|Reported Event|Arm I: Induction Rituximab|Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
11385372|NCT00075946|EG001|Reported Event|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
11385373|NCT00075946|EG002|Reported Event|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
11385374|NCT00003641|BG000|Baseline|Observation|Patients undergo observation for 4 weeks.
11385375|NCT00003641|BG001|Baseline|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
11385376|NCT00003641|BG002|Baseline|Total|Total of all reporting groups
11385377|NCT00003641|FG000|Participant Flow|Observation|Patients undergo observation for 4 weeks.
11385378|NCT00003641|FG001|Participant Flow|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
11385379|NCT00003641|OG000|Outcome|Observation|Patients undergo observation for 4 weeks.
11385380|NCT00003641|OG001|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
11385381|NCT00003641|EG000|Reported Event|Observation|Patients undergo observation for 4 weeks
11385382|NCT00003641|EG001|Reported Event|Interferon Alfa-2b|Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
10799970|NCT02981472|OG004|Outcome|Participants Weight Range 25 to < 35 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between 25 to < 35 kg will be administered 4mg apixaban twice daily (BID)."
11385383|NCT01956669|BG000|Baseline|Cohort 1: Rhabdomyosarcoma (RMS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385384|NCT01956669|BG001|Baseline|Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385385|NCT01956669|BG002|Baseline|Cohort 3: Ewing Sarcoma/pPNET (Ewing)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385386|NCT01956669|BG003|Baseline|Cohort 4 (Osteosarcoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385387|NCT01956669|BG004|Baseline|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385388|NCT01956669|BG005|Baseline|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385389|NCT01956669|BG006|Baseline|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385390|NCT01956669|BG007|Baseline|Total|Total of all reporting groups
11385391|NCT01956669|FG000|Participant Flow|Cohort 1: Rhabdomyosarcoma (RMS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385392|NCT01956669|FG001|Participant Flow|Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385393|NCT01956669|FG002|Participant Flow|Cohort 3: Ewing Sarcoma/pPNET (Ewing)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385394|NCT01956669|FG003|Participant Flow|Cohort 4 (Osteosarcoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385395|NCT01956669|FG004|Participant Flow|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385396|NCT01956669|FG005|Participant Flow|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385397|NCT01956669|FG006|Participant Flow|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385398|NCT01956669|OG000|Outcome|Cohort 1: Rhabdomyosarcoma (RMS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385399|NCT01956669|OG001|Outcome|Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385400|NCT01956669|OG002|Outcome|Cohort 3: Ewing Sarcoma/pPNET (Ewing)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385401|NCT01956669|OG000|Outcome|Cohort 4 (Osteosarcoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385402|NCT01956669|OG001|Outcome|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385403|NCT01956669|OG002|Outcome|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385404|NCT01956669|OG003|Outcome|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385405|NCT01956669|OG003|Outcome|Cohort 4 (Osteosarcoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385406|NCT01956669|OG004|Outcome|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385407|NCT01956669|OG005|Outcome|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385408|NCT01956669|OG006|Outcome|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385409|NCT01956669|OG001|Outcome|Cohort 3: Ewing Sarcoma/pPNET (Ewing)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385410|NCT01956669|OG002|Outcome|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11196786|NCT02167139|OG001|Outcome|Humira (Adalimumab) at Week 24|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11196787|NCT02167139|OG002|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 52|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
11196788|NCT02167139|OG003|Outcome|Humira (Adalimumab), Switch to SB5 at Week 52|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11196789|NCT02167139|OG004|Outcome|Humira (Adalimumab), Continue as Humira at Week 52|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
11196790|NCT02167139|EG000|Reported Event|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
11196791|NCT02167139|EG001|Reported Event|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
11196792|NCT02167204|BG000|Baseline|Diagnostic (18F-FLT PET/CT)|Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
11196793|NCT02167204|FG000|Participant Flow|Diagnostic (18F-FLT PET/CT)|Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
11196794|NCT02167204|OG000|Outcome|2 Diagnostic (18F-FLT PET/CT)Scans|Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy
11385411|NCT01956669|OG003|Outcome|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385412|NCT01956669|OG004|Outcome|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385413|NCT01956669|EG000|Reported Event|Cohort 1: Rhabdomyosarcoma (RMS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11196795|NCT02167204|OG001|Outcome|2 or 3 Diagnostic (18F-FLT PET/CT) Scans|Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
11196796|NCT02167204|OG000|Outcome|2 Diagnostic (18F-FLT PET/CT) Scans|Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy
11196797|NCT02167204|OG001|Outcome|2 or 3 Diagnostic (18F-FLT PET/CT) Scans|Patients completing three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
11196798|NCT02167204|OG000|Outcome|2 Diagnostic (18F-FLT PET/CT) Scans|Patients undergo two 18F-FLT PET/CT at baseline (pre-therapy) and mid-therapy
11196799|NCT02167204|OG001|Outcome|2 or 3 Diagnostic (18F-FLT PET/CT) Scans|Patients undergo three 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy and completion of therapy
11196800|NCT02167204|OG000|Outcome|Diagnostic (18F-FLT PET/CT)|Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
11196801|NCT02167204|EG000|Reported Event|Diagnostic (18F-FLT PET/CT)|Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
11196802|NCT02167217|BG000|Baseline|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast~Twenty-five steroid naïve boys four to 30 months of age with genetically confirmed Duchenne Muscular Dystrophy (DMD) were enrolled. 25 infants and boys were enrolled and 23 completed the study. One boy was lost to follow-up and one discontinued treatment after six months secondary to side effects."
11196803|NCT02167217|FG000|Participant Flow|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
11196804|NCT02167217|OG000|Outcome|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
11196805|NCT02167217|EG000|Reported Event|Oral Prednisolone|"Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast~Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast"
11196806|NCT02167256|BG000|Baseline|AZD0530 100mg Daily|"Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of <100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.~AZD0530 100mg daily: All patients in experimental group (50%) will be started on 100mg AZD0530 daily~AZD0530 125mg daily: Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530."
11385414|NCT01956669|EG001|Reported Event|Cohort 2: Nonrhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385415|NCT01956669|EG002|Reported Event|Cohort 3: Ewing Sarcoma/pPNET (Ewing)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385416|NCT01956669|EG003|Reported Event|Cohort 4 (Osteosarcoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385417|NCT01956669|EG004|Reported Event|Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385418|NCT01956669|EG005|Reported Event|Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385419|NCT01956669|EG006|Reported Event|Cohort 7 (Hepatoblastoma)|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
11385420|NCT01956669|EG007|Reported Event|All Subjects|Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m^2/dose or as a powder in suspension at a dose of 225 mg/m^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m^2/dose was not tolerated (>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
10799971|NCT02981472|OG005|Outcome|Participants Weight Range ≥ 35 kg|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between ≥ 35 kg will be administered 5mg apixaban twice daily (BID)."
11385421|NCT01967823|BG000|Baseline|Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes|"Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.~Fludarabine: Days -7 to -3: Fludarabine 25 mg /m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)."
11385422|NCT01967823|FG000|Participant Flow|Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes|"Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.~Fludarabine: Days -7 to -3: Fludarabine 25 mg /m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)."
11385423|NCT01967823|OG000|Outcome|Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes|"Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.~Fludarabine: Days -7 to -3: Fludarabine 25 mg /m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)."
11385424|NCT01967823|OG000|Outcome|T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells on Day of Infusion.|T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells on day of infusion.
11385425|NCT01967823|OG001|Outcome|T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 3 (± 1) Months|"T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 3 (±~1) Months"
11385426|NCT01967823|OG002|Outcome|T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 6 (± 2) Months|T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 6 (± 2) Months
11385427|NCT01967823|OG003|Outcome|T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at ≥ 1 Year|T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at ≥ 1 Year
11385428|NCT01967823|EG000|Reported Event|Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes|"Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin~Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.~Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.~Fludarabine: Days -7 to -3: Fludarabine 25 mg /m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.~Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)."
11385429|NCT01989676|BG000|Baseline|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385430|NCT01989676|BG001|Baseline|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385431|NCT01989676|BG002|Baseline|Total|Total of all reporting groups
11196807|NCT02167256|BG001|Baseline|AZD0530 Placebo|"50% of patients will receive placebo treatment for the duration of the study,~Placebo: 50% of patients will receive placebo treatment for the duration of the study."
11196808|NCT02167256|BG002|Baseline|Total|Total of all reporting groups
11196809|NCT02167256|FG000|Participant Flow|AZD0530 100mg/125mg Daily|"AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily~AZD0530 125mg daily: Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530."
11385432|NCT01989676|FG000|Participant Flow|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385433|NCT01989676|FG001|Participant Flow|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385434|NCT01989676|OG000|Outcome|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385435|NCT01989676|OG001|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385436|NCT01989676|OG000|Outcome|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385437|NCT01989676|EG000|Reported Event|PF-05280014|Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
11385438|NCT01989676|EG001|Reported Event|Trastuzumab-EU|Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
10799972|NCT02981472|EG000|Reported Event|Apixaban|"Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight.~Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID)."
11385439|NCT01992653|BG000|Baseline|Polatuzumab Vedotin (1.0mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385440|NCT01992653|BG001|Baseline|Polatuzumab Vedotin (1.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385441|NCT01992653|BG002|Baseline|Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385442|NCT01992653|BG003|Baseline|Polatuzumab Vedotin (2.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
11385443|NCT01992653|BG004|Baseline|Polatuzumab Vedotin (1.4mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385444|NCT01992653|BG005|Baseline|Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385445|NCT01992653|BG006|Baseline|Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385446|NCT01992653|BG007|Baseline|Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385447|NCT01992653|BG008|Baseline|Total|Total of all reporting groups
11385448|NCT01992653|FG000|Participant Flow|Polatuzumab Vedotin (1.0mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385449|NCT01992653|FG001|Participant Flow|Polatuzumab Vedotin (1.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385450|NCT01992653|FG002|Participant Flow|Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385451|NCT01992653|FG003|Participant Flow|Polatuzumab Vedotin (2.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
11385452|NCT01992653|FG004|Participant Flow|Polatuzumab Vedotin (1.4mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385453|NCT01992653|FG005|Participant Flow|Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385454|NCT01992653|FG006|Participant Flow|Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385455|NCT01992653|FG007|Participant Flow|Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385456|NCT01992653|OG000|Outcome|Polatuzumab Vedotin (1.0mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385457|NCT01992653|OG001|Outcome|Polatuzumab Vedotin (1.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385458|NCT01992653|OG002|Outcome|Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385459|NCT01992653|OG003|Outcome|Polatuzumab Vedotin (2.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
11385460|NCT01992653|OG004|Outcome|Polatuzumab Vedotin (1.4mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385461|NCT01992653|OG005|Outcome|Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385462|NCT01992653|OG006|Outcome|Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385463|NCT01992653|OG007|Outcome|Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385464|NCT01992653|EG000|Reported Event|Polatuzumab Vedotin (1.0mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385465|NCT01992653|EG001|Reported Event|Polatuzumab Vedotin (1.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385466|NCT01992653|EG002|Reported Event|Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
11385467|NCT01992653|EG003|Reported Event|Polatuzumab Vedotin (2.4mg) + R-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
11385468|NCT01992653|EG004|Reported Event|Polatuzumab Vedotin (1.4mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385469|NCT01992653|EG005|Reported Event|Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
11385470|NCT01992653|EG006|Reported Event|Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
11385471|NCT01992653|EG007|Reported Event|Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP|Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
10799973|NCT02981472|EG001|Reported Event|Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)|"Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first.~Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH."
10803571|NCT03417245|EG001|Reported Event|Fitusiran 80 mg Prophylaxis|Participants received open-label fitusiran 80 milligram (mg) administered subcutaneously (SC) as prophylaxis once monthly from Day 1 up to a total of 9 months. Participants received on-demand factor concentrates (per investigator's discretion and within bleeding dosing guidelines) for the treatment of breakthrough bleeding episodes.
10803572|NCT03417102|BG000|Baseline|Bypassing Agents (BPA) On-demand|Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11196810|NCT02167256|FG001|Participant Flow|AZD0530 Placebo|Placebo: 50% of patients will receive placebo treatment for the duration of the study.
11385472|NCT02001974|BG000|Baseline|Group 1|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)
11385473|NCT02001974|BG001|Baseline|Group 2|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)
11385474|NCT02001974|BG002|Baseline|Group 3|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 50% increase to 1200 mg t.i.d. if no toxicity in previous group (800 mg) three weeks on one week off (three to six patients).
11385475|NCT02001974|BG003|Baseline|Total|Total of all reporting groups
11385476|NCT02001974|FG000|Participant Flow|Paclitaxel 80 mg/m2 i.v.+Reparixin Oral 400 mg t.i.d.|"Paclitaxel+reparixin three weeks on one week off (three to six patients)~Paclitaxel+Reparixin: Association of Paclitaxel at fixed dosage with three increasing dosage of Reparixin"
11385477|NCT02001974|FG001|Participant Flow|Paclitaxel 80 mg/m2 i.v.+Reparixin Oral 800 mg t.i.d.|"Paclitaxel+reparixin three weeks on one week off (three to six patients)~Paclitaxel+Reparixin: Association of Paclitaxel at fixed dosage with three increasing dosage of Reparixin"
11385478|NCT02001974|FG002|Participant Flow|Paclitaxel 80 mg/m2 i.v.+Reparixin Oral 1200 mg t.i.d.|"Paclitaxel+reparixin oral three weeks on one week off (three to six patients).~Paclitaxel+Reparixin: Association of Paclitaxel at fixed dosage with three increasing dosage of Reparixin"
11385479|NCT02001974|OG000|Outcome|Group 1|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)
10799974|NCT02853760|BG000|Baseline|All Study Participants|
10799975|NCT02853760|FG000|Participant Flow|Sequence Group MTC|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was M, followed by T, followed by C."
11385480|NCT02001974|OG001|Outcome|Group 2|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)
11385481|NCT02001974|OG002|Outcome|Group 3|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 50% increase to 1200 mg t.i.d. if no toxicity in previous group (800 mg) three weeks on one week off (three to six patients).
11385482|NCT02001974|EG000|Reported Event|Group 1|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 400 mg three times daily (t.i.d.) three weeks on one week off (three to six patients)
11385483|NCT02001974|EG001|Reported Event|Group 2|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 100% increase to 800 mg t.i.d. if no toxicity in previous group (400 mg) three weeks on one week off (three to six patients)
11385484|NCT02001974|EG002|Reported Event|Group 3|Paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + reparixin oral 50% increase to 1200 mg t.i.d. if no toxicity in previous group (800 mg) three weeks on one week off (three to six patients).
11385485|NCT02014558|BG000|Baseline|Gilteritinib 20 mg in Escalation Phase|Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385486|NCT02014558|BG001|Baseline|Gilteritinib 40 mg in Escalation Phase|Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385487|NCT02014558|BG002|Baseline|Gilteritinib 80 mg in Escalation Phase|Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385488|NCT02014558|BG003|Baseline|Gilteritinib 120 mg in Escalation Phase|Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385489|NCT02014558|BG004|Baseline|Gilteritinib 200 mg in Escalation Phase|Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385490|NCT02014558|BG005|Baseline|Gilteritinib 300 mg in Escalation Phase|Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385491|NCT02014558|BG006|Baseline|Gilteritinib 450 mg in Escalation Phase|Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
10799976|NCT02853760|FG001|Participant Flow|Sequence Group MCT|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was M, followed by C followed by T."
10799977|NCT02853760|FG002|Participant Flow|Sequence Group TMC|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was T, followed by M, followed by C."
11385492|NCT02014558|BG007|Baseline|Gilteritinib 20 mg in Expansion Phase|Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
11385493|NCT02014558|BG008|Baseline|Gilteritinib 40 mg in Expansion Phase|Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385494|NCT02014558|BG009|Baseline|Gilteritinib 80 mg in Expansion Phase|Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385495|NCT02014558|BG010|Baseline|Gilteritinib 120 mg in Expansion Phase|Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385496|NCT02014558|BG011|Baseline|Gilteritinib 200 mg in Expansion Phase|Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
11385497|NCT02014558|BG012|Baseline|Gilteritinib 300 mg in Expansion Phase|Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
11385498|NCT02014558|BG013|Baseline|Total|Total of all reporting groups
11385499|NCT02014558|FG000|Participant Flow|Gilteritinib 20 mg in Escalation Phase|Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385500|NCT02014558|FG001|Participant Flow|Gilteritinib 40 mg in Escalation Phase|Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385501|NCT02014558|FG002|Participant Flow|Gilteritinib 80 mg in Escalation Phase|Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385502|NCT02014558|FG003|Participant Flow|Gilteritinib 120 mg in Escalation Phase|Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385503|NCT02014558|FG004|Participant Flow|Gilteritinib 200 mg in Escalation Phase|Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385504|NCT02014558|FG005|Participant Flow|Gilteritinib 300 mg in Escalation Phase|Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385505|NCT02014558|FG006|Participant Flow|Gilteritinib 450 mg in Escalation Phase|Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385506|NCT02014558|FG007|Participant Flow|Gilteritinib 20 mg in Expansion Phase|Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
11385507|NCT02014558|FG008|Participant Flow|Gilteritinib 40 mg in Expansion Phase|Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385508|NCT02014558|FG009|Participant Flow|Gilteritinib 80 mg in Expansion Phase|Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385509|NCT02014558|FG010|Participant Flow|Gilteritinib 120 mg in Expansion Phase|Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385510|NCT02014558|FG011|Participant Flow|Gilteritinib 200 mg in Expansion Phase|Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
11385511|NCT02014558|FG012|Participant Flow|Gilteritinib 300 mg in Expansion Phase|Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
11196811|NCT02167256|OG000|Outcome|AZD0530 100mg/125mg Daily|"AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily~AZD0530 125mg daily: Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530."
11196812|NCT02167256|OG001|Outcome|AZD0530 Placebo|Placebo: 50% of patients will receive placebo treatment for the duration of the study.
11196813|NCT02167256|EG000|Reported Event|AZD0530 100mg/125mg Daily|"AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily~AZD0530 125mg daily: Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530."
11196814|NCT02167256|EG001|Reported Event|AZD0530 Placebo|Placebo: 50% of patients will receive placebo treatment for the duration of the study.
11385512|NCT02014558|OG000|Outcome|Gilteritinib 20 mg in Escalation Phase|Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385513|NCT02014558|OG001|Outcome|Gilteritinib 40 mg in Escalation Phase|Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385514|NCT02014558|OG002|Outcome|Gilteritinib 80 mg in Escalation Phase|Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385515|NCT02014558|OG003|Outcome|Gilteritinib 120 mg in Escalation Phase|Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385516|NCT02014558|OG004|Outcome|Gilteritinib 200 mg in Escalation Phase|Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385517|NCT02014558|OG005|Outcome|Gilteritinib 300 mg in Escalation Phase|Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385518|NCT02014558|OG006|Outcome|Gilteritinib 450 mg in Escalation Phase|Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385519|NCT02014558|OG007|Outcome|Gilteritinib 20 mg in Expansion Phase|Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
11385520|NCT02014558|OG008|Outcome|Gilteritinib 40 mg in Expansion Phase|Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385521|NCT02014558|OG009|Outcome|Gilteritinib 80 mg in Expansion Phase|Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385522|NCT02014558|OG010|Outcome|Gilteritinib 120 mg in Expansion Phase|Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385523|NCT02014558|OG011|Outcome|Gilteritinib 200 mg in Expansion Phase|Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
10799978|NCT02853760|FG003|Participant Flow|Sequence Group TCM|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was T, followed by C, followed by M."
11196815|NCT02167451|BG000|Baseline|Maraviroc|"Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).~Maraviroc"
11196816|NCT02167451|FG000|Participant Flow|Maraviroc|"Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).~Maraviroc"
11196817|NCT02167451|OG000|Outcome|Maraviroc|"Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).~Maraviroc"
11196818|NCT02167451|EG000|Reported Event|Maraviroc|"Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).~Maraviroc"
11385524|NCT02014558|OG012|Outcome|Gilteritinib 300 mg in Expansion Phase|Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
11385525|NCT02014558|OG003|Outcome|Gilteritinib 120 mg in Escalation Phase|Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385526|NCT02014558|OG000|Outcome|Gilteritinib 20 mg in Escalation Phase|Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..
11196819|NCT02167594|BG000|Baseline|PSP Subjects|"Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11196820|NCT02167594|BG001|Baseline|CBD Subjects|"Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11385527|NCT02014558|OG001|Outcome|Gilteritinib 40 mg in Escalation Phase|Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..
11385528|NCT02014558|OG006|Outcome|Gilteritinib 450 mg in Escalation Phase|Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in in the escalation phase of the study.28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385529|NCT02014558|OG000|Outcome|Gilteritinib 20 mg|Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385530|NCT02014558|OG001|Outcome|Gilteritinib 40 mg|Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385531|NCT02014558|OG002|Outcome|Gilteritinib 80 mg|Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385532|NCT02014558|OG003|Outcome|Gilteritinib 120 mg|Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11196821|NCT02167594|BG002|Baseline|Healthy Volunteers|"Healthy volunteers receiving a flortaucipir PET scan at baseline.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11196822|NCT02167594|BG003|Baseline|Total|Total of all reporting groups
11196823|NCT02167594|FG000|Participant Flow|PSP Subjects|Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan
11196824|NCT02167594|FG001|Participant Flow|CBD Subjects|Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan
11196825|NCT02167594|FG002|Participant Flow|Healthy Volunteers|Healthy volunteers receiving a flortaucipir PET scan
11196826|NCT02167594|OG000|Outcome|PSP Subjects|"Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11196827|NCT02167594|OG001|Outcome|CBD Subjects|"Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11196828|NCT02167594|OG002|Outcome|Healthy Volunteers|"Healthy volunteers receiving a flortaucipir PET scan at baseline.~Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)"
11196829|NCT02167594|OG003|Outcome|All Subjects|All subjects combined
11196830|NCT02167594|EG000|Reported Event|PSP Subjects|Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan
11196831|NCT02167594|EG001|Reported Event|CBD Subjects|Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan
11196832|NCT02167594|EG002|Reported Event|Healthy Volunteers|Healthy volunteers receiving a flortaucipir PET scan
11385533|NCT02014558|OG004|Outcome|Gilteritinib 200 mg|Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385534|NCT02014558|OG005|Outcome|Gilteritinib 300 mg|Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385535|NCT02014558|OG006|Outcome|Gilteritinib 450 mg|Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
11385536|NCT02014558|OG000|Outcome|Gilteritinib 20 mg in Expansion Phase|Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
10799979|NCT02853760|FG004|Participant Flow|Sequence Group CTM|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was C, followed by T, followed by M."
10799980|NCT02853760|FG005|Participant Flow|Sequence Group CMT|"All participants were exposed to three different conditions in a randomized starting order: outdoor mountain hiking (M), indoor treadmill walking (T), and sedentary control situation (C) (approximately three hours each).~The order of conditions of the present group was C, followed by M, followed by T."
10799981|NCT02853760|OG000|Outcome|Outdoor Mountain Hiking (M)|"First part of the intervention: an uphill walking phase on single trails and forest roads in a sparse forest with view on the mountainous region around Innsbruck for 6 km in around 1.5 hours together with the test leader. Regarding the walking intensity, the participants were instructed to choose a brisk without overspending pace (average speed: 4 km/h).~In the second part of the intervention, the participants were walking downhill on the same track for around 70 minutes back to the starting point to respond to the post-test (average speed: 5.2 km/h).~walking"
10799982|NCT02853760|OG001|Outcome|Indoor Treadmill Walking (T)|"To ensure that all physical parameters were simultaneous to the outdoor mountain hiking condition, the distance, the difference in height, the average inclination of the track, and the time needed for the outdoor mountain hiking situation were measured in a pilot study.~First part: uphill walking, inclination: 10%, time: 1.5 hours, and speed: 4 km/h (resulting in 600 m difference in height). In accordance to possible differences in outdoor speed, the participants were allowed to change the treadmill's speed in a small range (3.8 to 4.2 km/h) to adapt to the wording brisk without overspending. Second part of the intervention contained 70 minutes of level walking on the same treadmills (5.2 km/h, 6km).~walking~Treadmill"
10799983|NCT02853760|OG002|Outcome|Sedentary Control Condition (C)|The sedentary control situation was located in a quiet room at the university with access to computers. The participants were allowed to use the computers, to read, and to talk, but had to remain in a sedentary position. To control for possible differences in affective response due to the daytime, the sedentary control condition contained the same timing of the measurements than the intervention condition. Sociodemographic data were collected for 5 to 10 minutes in this condition using a web-based questionnaire.
10799984|NCT02853760|EG000|Reported Event|Outdoor Mountain Hiking (M)|"First part of the intervention: an uphill walking phase on single trails and forest roads in a sparse forest with view on the mountainous region around Innsbruck for 6 km in around 1.5 hours together with the test leader. Regarding the walking intensity, the participants were instructed to choose a brisk without overspending pace (average speed: 4 km/h).~In the second part of the intervention, the participants were walking downhill on the same track for around 70 minutes back to the starting point to respond to the post-test (average speed: 5.2 km/h).~walking"
10799985|NCT02853760|EG001|Reported Event|Indoor Treadmill Walking (T)|"To ensure that all physical parameters were simultaneous to the outdoor mountain hiking condition, the distance, the difference in height, the average inclination of the track, and the time needed for the outdoor mountain hiking situation were measured in a pilot study.~First part: uphill walking, inclination: 10%, time: 1.5 hours, and speed: 4 km/h (resulting in 600 m difference in height). In accordance to possible differences in outdoor speed, the participants were allowed to change the treadmill's speed in a small range (3.8 to 4.2 km/h) to adapt to the wording brisk without overspending. Second part of the intervention contained 70 minutes of level walking on the same treadmills (5.2 km/h, 6km).~walking~Treadmill"
10799986|NCT02853760|EG002|Reported Event|Sedentary Control Condition (C)|The sedentary control situation was located in a quiet room at the university with access to computers. The participants were allowed to use the computers, to read, and to talk, but had to remain in a sedentary position. To control for possible differences in affective response due to the daytime, the sedentary control condition contained the same timing of the measurements than the intervention condition. Sociodemographic data were collected for 5 to 10 minutes in this condition using a web-based questionnaire.
10799987|NCT02789657|BG000|Baseline|Experimental: Optimal- 18 Weeks|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10799988|NCT02789657|BG001|Baseline|Experimental: Sub-optimal With AC|12 weeks (4 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post 12 weeks, initiation of doxorubicin and cyclophosphamide for 4 cycles (6 weeks), followed by surgery.
10799989|NCT02789657|BG002|Baseline|Experimental: Optimal With AC|Less than 18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab, followed by initiation of doxorubicin and cyclophosphamide. Post treatment, patients will undergo surgery.
10799990|NCT02789657|BG003|Baseline|Experimental: Sub-optimal no AC|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10799991|NCT02789657|BG004|Baseline|Total|Total of all reporting groups
10799992|NCT02789657|FG000|Participant Flow|Experimental: Optimal- 18 Weeks|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10799993|NCT02789657|FG001|Participant Flow|Experimental: Sub-optimal With AC|12 weeks (4 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post 12 weeks, initiation of doxorubicin and cyclophosphamide for 4 cycles (6 weeks), followed by surgery.
10799994|NCT02789657|FG002|Participant Flow|Experimental: Optimal With AC|Less than 18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab, followed by initiation of doxorubicin and cyclophosphamide. Post treatment, patients will undergo surgery.
11196833|NCT02167815|BG000|Baseline|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
10799995|NCT02789657|FG003|Participant Flow|Experimental: Sub-optimal no AC|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10799996|NCT02789657|OG000|Outcome|Experimental: Optimal- 18 Weeks|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
11196834|NCT02167815|BG001|Baseline|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
11196835|NCT02167815|BG002|Baseline|Total|Total of all reporting groups
11196836|NCT02167815|FG000|Participant Flow|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
11196837|NCT02167815|FG001|Participant Flow|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
11196838|NCT02167815|OG000|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
11196839|NCT02167815|OG001|Outcome|Standard Care|observation group, treating according to investigation sites standard care
11196840|NCT02167815|OG001|Outcome|Standard Care|observation group, treated according to investigation sites standard care
11196841|NCT02167815|OG001|Outcome|Standard Care|observation group, treated according to investigation sites, standard care
11385537|NCT02014558|OG000|Outcome|Gilteritinib 300 mg in Expansion Phase|Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
11385538|NCT02014558|OG000|Outcome|Gilteritinib 200 mg in Expansion Phase|Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
11385539|NCT02014558|EG000|Reported Event|Gilterinib 20 mg in Escalation Phase|Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385540|NCT02014558|EG001|Reported Event|Gilterinib 40 mg in Escalation Phase|Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385541|NCT02014558|EG002|Reported Event|Gilterinib 80 mg in Escalation Phase|Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385542|NCT02014558|EG003|Reported Event|Gilterinib 120 mg in Escalation Phase|Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385543|NCT02014558|EG004|Reported Event|Gilterinib 200 mg in Escalation Phase|Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385544|NCT02014558|EG005|Reported Event|Gilterinib 300 mg in Escalation Phase|Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385545|NCT02014558|EG006|Reported Event|Gilterinib 450 mg in Escalation Phase|Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
11385546|NCT02014558|EG007|Reported Event|Gilterinib 20 mg in Expansion Phase|Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
11385547|NCT02014558|EG008|Reported Event|Gilterinib 40 mg in Expansion Phase|Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
10799997|NCT02789657|OG001|Outcome|Experimental: Sub-optimal With AC|12 weeks (4 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post 12 weeks, initiation of doxorubicin and cyclophosphamide for 4 cycles (6 weeks), followed by surgery.
11196842|NCT02167815|EG000|Reported Event|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
11196843|NCT02167815|EG001|Reported Event|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
11196844|NCT02167867|BG000|Baseline|Lay End Users|Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
11196845|NCT02167867|BG001|Baseline|Treatment Subject Group|Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
11196846|NCT02167867|BG002|Baseline|Total|Total of all reporting groups
11196847|NCT02167867|FG000|Participant Flow|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject.
11196848|NCT02167867|FG001|Participant Flow|Treatment Subject Group|Subjects who received active treatments with the study device administered by the Lay End Users.
11196849|NCT02167867|OG000|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
11196850|NCT02167867|OG000|Outcome|Treatment Subject Group|Individuals who got the active treatments with the ZERONA Z6.
11385548|NCT02014558|EG009|Reported Event|Gilterinib 80 mg in Expansion Phase|Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11196851|NCT02167867|EG000|Reported Event|ZERONA Z6|"ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.~ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs."
11196852|NCT02167893|BG000|Baseline|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
11385549|NCT02014558|EG010|Reported Event|Gilterinib 120 mg in Expansion Phase|Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
11385550|NCT02014558|EG011|Reported Event|Gilterinib 200 mg in Expansion Phase|Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
11385551|NCT02014558|EG012|Reported Event|Gilterinib 300 mg in Expansion Phase|Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
11196853|NCT02167893|FG000|Participant Flow|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
11196854|NCT02167893|OG000|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
11385552|NCT02015455|BG000|Baseline|Control|Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
11385553|NCT02015455|BG001|Baseline|Intervention|Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
11385554|NCT02015455|BG002|Baseline|Total|Total of all reporting groups
11385555|NCT02015455|FG000|Participant Flow|Control|Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
11385556|NCT02015455|FG001|Participant Flow|Intervention|Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
11385557|NCT02015455|OG000|Outcome|Control|Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
11385558|NCT02015455|OG001|Outcome|Intervention|Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
11385559|NCT02015455|OG000|Outcome|Control|Participants with plain film index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
11385560|NCT02015455|OG001|Outcome|Intervention|Participants with plain film index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
11385561|NCT02015455|EG000|Reported Event|Control|Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
11385562|NCT02015455|EG001|Reported Event|Intervention|Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
11196855|NCT02167893|EG000|Reported Event|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
11196856|NCT02168062|BG000|Baseline|Arm I (Standard of Care)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11196857|NCT02168062|BG001|Baseline|Arm II (STAND Clinic)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.~Behavioral Dietary Intervention: Receive individualized nutrition counseling~Counseling: Receive individualized symptom management service counseling~Educational Intervention: Review educational modules~Exercise Intervention: Receive individualized exercise counseling~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11196858|NCT02168062|BG002|Baseline|Non-Randomized Pilot Cohort|A non-randomized pilot cohort of 20 patients receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
11385563|NCT02024555|BG000|Baseline|Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin|"Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD~Levofloxacin~Ethambutol~Azithromycin~Rifampin"
11385564|NCT02024555|BG001|Baseline|Placebo|"Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.~The pill count will be the same as the comparator regimen.~Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy."
11385565|NCT02024555|BG002|Baseline|Total|Total of all reporting groups
11385566|NCT02024555|FG000|Participant Flow|Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin|"Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD~Levofloxacin~Ethambutol~Azithromycin~Rifampin"
11385567|NCT02024555|FG001|Participant Flow|Placebo|"Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.~The pill count will be the same as the comparator regimen.~Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy."
11196859|NCT02168062|BG003|Baseline|Total|Total of all reporting groups
11196860|NCT02168062|FG000|Participant Flow|Arm I (Standard of Care)|"Patients receive leuprolide acetate subcutaneous (SC) or intramuscular (IM), or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies"
11196861|NCT02168062|FG001|Participant Flow|Arm II (STAND Clinic)|"Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.~Behavioral Dietary Intervention: Receive individualized nutrition counseling~Counseling: Receive individualized symptom management service counseling~Educational Intervention: Review educational modules~Exercise Intervention: Receive individualized exercise counseling~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies"
11196862|NCT02168062|FG002|Participant Flow|Non-Randomized Pilot Cohort|A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
11196863|NCT02168062|OG000|Outcome|Arm I (Standard of Care)|"Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies"
11385568|NCT02024555|OG000|Outcome|Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin|"Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD~Levofloxacin~Ethambutol~Azithromycin~Rifampin"
11241356|NCT02486406|EG000|Reported Event|Adult Tablet, 12-17 yr, Part 1|Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
11385569|NCT02024555|OG001|Outcome|Placebo|"Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.~The pill count will be the same as the comparator regimen.~Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy."
11385570|NCT02024555|EG000|Reported Event|Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin|"Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD~Levofloxacin~Ethambutol~Azithromycin~Rifampin"
11385571|NCT02024555|EG001|Reported Event|Placebo|"Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.~The pill count will be the same as the comparator regimen.~Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy."
10799998|NCT02789657|OG002|Outcome|Experimental: Optimal With AC|Less than 18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab, followed by initiation of doxorubicin and cyclophosphamide. Post treatment, patients will undergo surgery.
10799999|NCT02789657|OG003|Outcome|Experimental: Sub-optimal no AC|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10800000|NCT02789657|EG000|Reported Event|Experimental: Optimal- 18 Weeks|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10800001|NCT02789657|EG001|Reported Event|Experimental: Sub-optimal With AC|12 weeks (4 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post 12 weeks, initiation of doxorubicin and cyclophosphamide for 4 cycles (6 weeks), followed by surgery.
10800002|NCT02789657|EG002|Reported Event|Experimental: Sub-optimal no AC|18 weeks (6 cycles) of paclitaxel, carboplatin, trastuzumab and pertuzumab. Post treatment, patients will undergo surgery.
10800003|NCT02743871|BG000|Baseline|Part 1 Cohort 1: PF-06817024 10 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
10800004|NCT02743871|BG001|Baseline|Part 1 Cohort 2: PF-06817024 30 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
10800005|NCT02743871|BG002|Baseline|Part 1 Cohort 7: PF-06817024 30 mg SC SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
10800006|NCT02743871|BG003|Baseline|Part 1 Cohort 3: PF-06817024 100 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
10800007|NCT02743871|BG004|Baseline|Part 1 Cohort 3: PF-06817024 100 mg IV MD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
10800008|NCT02743871|BG005|Baseline|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
11196864|NCT02168062|OG001|Outcome|Arm II (STAND Clinic)|"Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.~Behavioral Dietary Intervention: Receive individualized nutrition counseling~Counseling: Receive individualized symptom management service counseling~Educational Intervention: Review educational modules~Exercise Intervention: Receive individualized exercise counseling~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies"
11196865|NCT02168062|OG000|Outcome|Non-Randomized Pilot Cohort|A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
10800009|NCT02743871|BG006|Baseline|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
10800010|NCT02743871|BG007|Baseline|Part 1: Placebo IV SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800011|NCT02743871|BG008|Baseline|Part 1 Cohort 3: Placebo IV MD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
10800012|NCT02743871|BG009|Baseline|Part 1 Cohort 7: Placebo SC SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
10800013|NCT02743871|BG010|Baseline|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
10800014|NCT02743871|BG011|Baseline|Part 2 Cohort 8: Placebo IV CRSwNP|Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800015|NCT02743871|BG012|Baseline|Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD|Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
10800016|NCT02743871|BG013|Baseline|Part 3 Cohort 13: Placebo IV AD|Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
10800017|NCT02743871|BG014|Baseline|Total|Total of all reporting groups
10800018|NCT02743871|FG000|Participant Flow|Part 1 Cohort 1: PF-06817024 10 mg Intravenously (IV) Single Dose (SD)|Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
10800019|NCT02743871|FG001|Participant Flow|Part 1 Cohort 2: PF-06817024 30 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
10800020|NCT02743871|FG002|Participant Flow|Part 1 Cohort 7: PF-06817024 30 mg Subcutaneously (SC) SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
10800021|NCT02743871|FG003|Participant Flow|Part 1 Cohort 3: PF-06817024 100 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
10800022|NCT02743871|FG004|Participant Flow|Part 1 Cohort 3: PF-06817024 100 mg IV Multiple Doses (MD)|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
10800023|NCT02743871|FG005|Participant Flow|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
10800024|NCT02743871|FG006|Participant Flow|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
10800025|NCT02743871|FG007|Participant Flow|Part 1: Placebo IV SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800026|NCT02743871|FG008|Participant Flow|Part 1 Cohort 3: Placebo IV MD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
10800027|NCT02743871|FG009|Participant Flow|Part 1 Cohort 7: Placebo SC SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
10800028|NCT02743871|FG010|Participant Flow|Part 2 Cohort 8: PF-06817024 300 mg IV Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)|Participants with chronic rhinosinusitis with nasal polyps (CRSwNP) received PF-06817024 300 mg IV for a SD on Study Day 1.
11385572|NCT02034123|BG000|Baseline|Part 1:GSK2879552 0.25 mg Daily|Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385573|NCT02034123|BG001|Baseline|Part 1:GSK2879552 0.5 mg Daily|Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385574|NCT02034123|BG002|Baseline|Part 1:GSK2879552 1.0 mg Daily|Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385575|NCT02034123|BG003|Baseline|Part 1:GSK2879552 1.5 mg Daily|Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385576|NCT02034123|BG004|Baseline|Part 1: GSK2879552 2.0 mg Daily|Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385577|NCT02034123|BG005|Baseline|Part 1: GSK2879552 3.0 mg Daily|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385578|NCT02034123|BG006|Baseline|Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385579|NCT02034123|BG007|Baseline|Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385580|NCT02034123|BG008|Baseline|Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385581|NCT02034123|BG009|Baseline|Part 2:GSK2879552 0.25 mg Daily|Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385582|NCT02034123|BG010|Baseline|Part 2:GSK2879552 0.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385583|NCT02034123|BG011|Baseline|Part 2:GSK2879552 1.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385584|NCT02034123|BG012|Baseline|Part 2:GSK2879552 1.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385585|NCT02034123|BG013|Baseline|Part 2: GSK2879552 2.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385586|NCT02034123|BG014|Baseline|Part 2: GSK2879552 3.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385587|NCT02034123|BG015|Baseline|Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385588|NCT02034123|BG016|Baseline|Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385589|NCT02034123|BG017|Baseline|Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385590|NCT02034123|BG018|Baseline|Total|Total of all reporting groups
11385591|NCT02034123|FG000|Participant Flow|Part 1:GSK2879552 0.25 mg Daily|Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385592|NCT02034123|FG001|Participant Flow|Part 1:GSK2879552 0.5 mg Daily|Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385593|NCT02034123|FG002|Participant Flow|Part 1:GSK2879552 1.0 mg Daily|Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385594|NCT02034123|FG003|Participant Flow|Part 1:GSK2879552 1.5 mg Daily|Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385595|NCT02034123|FG004|Participant Flow|Part 1: GSK2879552 2.0 mg Daily|Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385596|NCT02034123|FG005|Participant Flow|Part 1: GSK2879552 3.0 mg Daily|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385597|NCT02034123|FG006|Participant Flow|Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385598|NCT02034123|FG007|Participant Flow|Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385599|NCT02034123|FG008|Participant Flow|Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385600|NCT02034123|FG009|Participant Flow|Part 2:GSK2879552 0.25 mg Daily|Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
10800029|NCT02743871|FG011|Participant Flow|Part 2 Cohort 8: Placebo IV CRSwNP|Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
11385601|NCT02034123|FG010|Participant Flow|Part 2:GSK2879552 0.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385602|NCT02034123|FG011|Participant Flow|Part 2:GSK2879552 1.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385603|NCT02034123|FG012|Participant Flow|Part 2:GSK2879552 1.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385604|NCT02034123|FG013|Participant Flow|Part 2: GSK2879552 2.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385605|NCT02034123|FG014|Participant Flow|Part 2: GSK2879552 3.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385606|NCT02034123|FG015|Participant Flow|Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385607|NCT02034123|FG016|Participant Flow|Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385608|NCT02034123|FG017|Participant Flow|Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
10800030|NCT02743871|FG012|Participant Flow|Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV Atopic Dermatitis (AD)|Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
10800031|NCT02743871|FG013|Participant Flow|Part 3 Cohort 13: Placebo IV AD|Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
11385609|NCT02034123|OG000|Outcome|Part 1:GSK2879552 0.25 mg Daily|Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385610|NCT02034123|OG001|Outcome|Part 1:GSK2879552 0.5 mg Daily|Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385611|NCT02034123|OG002|Outcome|Part 1:GSK2879552 1.0 mg Daily|Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385612|NCT02034123|OG003|Outcome|Part 1:GSK2879552 1.5 mg Daily|Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385613|NCT02034123|OG004|Outcome|Part 1: GSK2879552 2.0 mg Daily|Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385614|NCT02034123|OG005|Outcome|Part 1: GSK2879552 3.0 mg Daily|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385615|NCT02034123|OG006|Outcome|Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385616|NCT02034123|OG007|Outcome|Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385617|NCT02034123|OG008|Outcome|Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385618|NCT02034123|OG000|Outcome|Part 2:GSK2879552 0.25 mg Daily|Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385619|NCT02034123|OG001|Outcome|Part 2:GSK2879552 0.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385620|NCT02034123|OG002|Outcome|Part 2:GSK2879552 1.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385621|NCT02034123|OG003|Outcome|Part 2:GSK2879552 1.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385622|NCT02034123|OG004|Outcome|Part 2: GSK2879552 2.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385623|NCT02034123|OG005|Outcome|Part 2: GSK2879552 3.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385624|NCT02034123|OG006|Outcome|Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385625|NCT02034123|OG007|Outcome|Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11196866|NCT02168062|OG000|Outcome|Arm I (Standard of Care)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11385626|NCT02034123|OG008|Outcome|Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385627|NCT02034123|OG000|Outcome|Part 1:GSK2879552 1.0 mg Daily|Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385628|NCT02034123|OG001|Outcome|Part 1: GSK2879552 2.0 mg Daily|Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385629|NCT02034123|OG002|Outcome|Part 1: GSK2879552 3.0 mg Daily|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385630|NCT02034123|OG000|Outcome|Part 1: Participants With Repeat Daily Dosing|Participants received repeat daily dosing with GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were escalated to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
11385631|NCT02034123|OG000|Outcome|Part 2 :Participants With Repeat Daily Dosing|Participants with repeat daily dosing were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were planned to escalate to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
11385632|NCT02034123|EG000|Reported Event|Part 1:GSK2879552 0.25 mg Daily|Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385633|NCT02034123|EG001|Reported Event|Part 1:GSK2879552 0.5 mg Daily|Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385634|NCT02034123|EG002|Reported Event|Part 1:GSK2879552 1.0 mg Daily|Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385635|NCT02034123|EG003|Reported Event|Part 1:GSK2879552 1.5 mg Daily|Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385636|NCT02034123|EG004|Reported Event|Part 1: GSK2879552 2.0 mg Daily|Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385637|NCT02034123|EG005|Reported Event|Part 1: GSK2879552 3.0 mg Daily|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385638|NCT02034123|EG006|Reported Event|Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385639|NCT02034123|EG007|Reported Event|Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385640|NCT02034123|EG008|Reported Event|Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385641|NCT02034123|EG009|Reported Event|Part 2:GSK2879552 0.25 mg Daily|Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385642|NCT02034123|EG010|Reported Event|Part 2:GSK2879552 0.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385643|NCT02034123|EG011|Reported Event|Part 2:GSK2879552 1.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385644|NCT02034123|EG012|Reported Event|Part 2:GSK2879552 1.5 mg Daily|Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385645|NCT02034123|EG013|Reported Event|Part 2: GSK2879552 2.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385646|NCT02034123|EG014|Reported Event|Part 2: GSK2879552 3.0 mg Daily|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
11385647|NCT02034123|EG015|Reported Event|Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
11385648|NCT02034123|EG016|Reported Event|Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11385649|NCT02034123|EG017|Reported Event|Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off|Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
11337951|NCT03597347|BG000|Baseline|Group 1|"Participants with chronic pulmonary MAC or MABSC infection who have not consistently achieved negative NTM sputum cultures while currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337952|NCT03597347|BG001|Baseline|Group 2|"Participants with chronic pulmonary MAC or MABSC infection who remain sputum culture positive but have stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337953|NCT03597347|BG002|Baseline|Group 3|"Participants with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF).~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337954|NCT03597347|BG003|Baseline|Total|Total of all reporting groups
11337955|NCT03597347|FG000|Participant Flow|Not Consistently NTM Sputum Negative|"Participants with chronic pulmonary MAC or MABSC infection who have not consistently achieved negative NTM sputum cultures while currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337956|NCT03597347|FG001|Participant Flow|NTM Sputum Positive|"Participants with chronic pulmonary MAC or MABSC infection who remain sputum culture positive but have stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337957|NCT03597347|FG002|Participant Flow|Did Not Meet Recommendations for Treatment With a Multidrug NTM Antimycobacterial Treatment|"Participants with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF).~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337958|NCT03597347|OG000|Outcome|Group 1|"Participants with chronic pulmonary MAC or MABSC infection who have not consistently achieved negative NTM sputum cultures while currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337959|NCT03597347|OG001|Outcome|Group 2|"Participants with chronic pulmonary MAC or MABSC infection who remain sputum culture positive but have stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337960|NCT03597347|OG002|Outcome|Group 3|"Participants with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF).~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337961|NCT03597347|EG000|Reported Event|Group 1|"Participants with chronic pulmonary MAC or MABSC infection who have not consistently achieved negative NTM sputum cultures while currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337962|NCT03597347|EG001|Reported Event|Group 2|"Participants with chronic pulmonary MAC or MABSC infection who remain sputum culture positive but have stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance.~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337963|NCT03597347|EG002|Reported Event|Group 3|"Participants with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF).~Molgramostim nebulizer solution: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation~PARI eFlow nebulizer system: PARI eFlow nebulizer system"
11337964|NCT03597529|BG000|Baseline|Low-Dose Melatonin (mg)|"melatonin 2mg (equal to or over 40kg)~melatonin 1mg (under 40kg)~Melatonin: melatonin"
11337965|NCT03597529|BG001|Baseline|High-Dose Melatonin (mg)|"melatonin 8mg (equal to or over 40kg)~melatonin 4mg (under 40kg)~Melatonin: melatonin"
11337966|NCT03597529|BG002|Baseline|Total|Total of all reporting groups
11337967|NCT03597529|FG000|Participant Flow|Low-Dose Melatonin (mg)|"melatonin 2mg (equal to or over 40kg)~melatonin 1mg (under 40kg)~Melatonin: melatonin"
11337968|NCT03597529|FG001|Participant Flow|High-Dose Melatonin (mg)|"melatonin 8mg (equal to or over 40kg)~melatonin 4mg (under 40kg)~Melatonin: melatonin"
11337969|NCT03597529|OG000|Outcome|Low-Dose Melatonin (mg)|"melatonin 2mg (equal to or over 40kg)~melatonin 1mg (under 40kg)~Melatonin: melatonin"
11337970|NCT03597529|OG001|Outcome|High-Dose Melatonin (mg)|"melatonin 8mg (equal to or over 40kg)~melatonin 4mg (under 40kg)~Melatonin: melatonin"
11337971|NCT03597529|EG000|Reported Event|Low-Dose Melatonin (mg)|"melatonin 2mg (equal to or over 40kg)~melatonin 1mg (under 40kg)~Melatonin: melatonin"
11385650|NCT02040584|BG000|Baseline|Experimental Group|Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids
11385651|NCT02040584|BG001|Baseline|Control Group|Treatment with TAC + MMF + corticosteroids
10800032|NCT02743871|OG000|Outcome|Part 1 Cohort 1: PF-06817024 10 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
10800033|NCT02743871|OG001|Outcome|Part 1 Cohort 2: PF-06817024 30 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
10800034|NCT02743871|OG002|Outcome|Part 1 Cohort 3: PF-06817024 30 mg SC SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
11337972|NCT03597529|EG001|Reported Event|High-Dose Melatonin (mg)|"melatonin 8mg (equal to or over 40kg)~melatonin 4mg (under 40kg)~Melatonin: melatonin"
11337973|NCT03597789|BG000|Baseline|Helping the NonCompliant Child Treatment|"Families will participate in approximately 10 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program Helping the Noncompliant Child (HNC) via weekly sessions and mid-week calls.~Helping the Noncompliant Child (HNC): HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior."
11337974|NCT03597789|FG000|Participant Flow|Helping the NonCompliant Child Treatment|"Families will participate in approximately 10 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program Helping the Noncompliant Child (HNC) via weekly sessions and mid-week calls.~Helping the Noncompliant Child (HNC): HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior."
11337975|NCT03597789|OG000|Outcome|Helping the NonCompliant Child Treatment|"Families will participate in approximately 10 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program Helping the Noncompliant Child (HNC) via weekly sessions and mid-week calls.~Helping the Noncompliant Child (HNC): HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior."
11337976|NCT03597789|EG000|Reported Event|Helping the NonCompliant Child Treatment|"Families will participate in approximately 10 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program Helping the Noncompliant Child (HNC) via weekly sessions and mid-week calls.~Helping the Noncompliant Child (HNC): HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior."
11337977|NCT03598647|BG000|Baseline|Exercisers|Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337978|NCT03598647|BG001|Baseline|Non-exercisers|Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337979|NCT03598647|BG002|Baseline|Total|Total of all reporting groups
11337980|NCT03598647|FG000|Participant Flow|Exercisers|Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337981|NCT03598647|FG001|Participant Flow|Non-exercisers|Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337982|NCT03598647|FG002|Participant Flow|Physical Activity Information|After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received basic information about physical activity, including the national physical activity guidelines, clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program.
11337983|NCT03598647|FG003|Participant Flow|Affect and Physical Activity|After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received the same basic information about physical activity as the 'physical activity information' group but they also received a brief intervention focused on affective responses to exercise. The focus of this intervention was to help the participant to become more aware of their positive feelings and experiences related to exercise. They learned about typical affective responses to exercise, viewed their own affective responses to exercise, and were taught cognitive strategies for altering affective responses to exercise.
11337984|NCT03598647|OG000|Outcome|Exercisers|Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337985|NCT03598647|OG001|Outcome|Non-exercisers|Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337986|NCT03598647|OG000|Outcome|Physical Activity Information|"Non-exercisers randomized to this condition will receive basic information about physical activity. This includes the national physical activity guidelines,clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program.~Physical activity information: Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity."
11337987|NCT03598647|OG001|Outcome|Affect and Physical Activity|"Non-exercisers randomized to this condition will receive the same basic information about physical activity as described above, but they will also receive a brief intervention focused on affective responses to exercise.~Affect and physical activity: The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity."
11337988|NCT03598647|EG000|Reported Event|Exercisers|Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337989|NCT03598647|EG001|Reported Event|Non-exercisers|Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
11337990|NCT03598647|EG002|Reported Event|Physical Activity Information|"Non-exercisers randomized to this condition will receive basic information about physical activity. This includes the national physical activity guidelines, clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program.~Physical activity information: Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity."
10800035|NCT02743871|OG003|Outcome|Part 1 Cohort 3: PF-06817024 100 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
10800036|NCT02743871|OG004|Outcome|Part 1 Cohort 3: PF-06817024 100 mg IV MD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
10800037|NCT02743871|OG005|Outcome|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
10800038|NCT02743871|OG006|Outcome|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
11196867|NCT02168062|OG001|Outcome|Arm II (STAND Clinic)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.~Behavioral Dietary Intervention: Receive individualized nutrition counseling~Counseling: Receive individualized symptom management service counseling~Educational Intervention: Review educational modules~Exercise Intervention: Receive individualized exercise counseling~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11385652|NCT02040584|BG002|Baseline|Total|Total of all reporting groups
11385653|NCT02040584|FG000|Participant Flow|Experimental Group|Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids
11385654|NCT02040584|FG001|Participant Flow|Control Group|Treatment with TAC + MMF + corticosteroids
11385655|NCT02040584|OG000|Outcome|Experimental Group|Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids
10800039|NCT02743871|OG007|Outcome|Part 1: Placebo IV SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
11385656|NCT02040584|OG001|Outcome|Control Group|Treatment with TAC + MMF + corticosteroids
10800040|NCT02743871|OG008|Outcome|Part 1 Cohort 3: Placebo IV MD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
10800041|NCT02743871|OG009|Outcome|Part 1 Cohort 7: Placebo SC SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
10800042|NCT02743871|OG002|Outcome|Part 1 Cohort 7: PF-06817024 30 mg SC SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
10800043|NCT02743871|OG000|Outcome|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
11385657|NCT02040584|OG000|Outcome|<= 14|Experimental group (Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids) with MELD score <= 14
11385658|NCT02040584|OG001|Outcome|15 to 19|Experimental group (Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids) with MELD score 15-19
11385659|NCT02040584|OG002|Outcome|20 to 24|Experimental group (Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids) with MELD score 20 to 24
11385660|NCT02040584|OG003|Outcome|25 to 29|Experimental group (Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids) with MELD score 25 to 29
11385661|NCT02040584|OG004|Outcome|> = 30|Experimental group (Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids) with MELD score > = 30
11385662|NCT02040584|OG005|Outcome|<= 14 Control Group|Control group (Treatment with TAC + MMF + corticosteroids) with MELD score <= 14
11385663|NCT02040584|OG006|Outcome|15 to 19 Control Group|Control group (Treatment with TAC + MMF + corticosteroids) with MELD score 15 to 19
11385664|NCT02040584|OG007|Outcome|20 to 24 Control Group|Control group (Treatment with TAC + MMF + corticosteroids) with MELD score 20 to 24
10800044|NCT02743871|OG001|Outcome|Part 2 Cohort 8: Placebo IV CRSwNP|Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800045|NCT02743871|OG000|Outcome|Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD|Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
10800046|NCT02743871|OG001|Outcome|Part 3 Cohort 13: Placebo IV AD|Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
10800047|NCT02743871|OG004|Outcome|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
10800048|NCT02743871|OG005|Outcome|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
10800049|NCT02743871|OG000|Outcome|Part 1 Cohort 3: PF-06817024 100 mg IV MD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
10800050|NCT02743871|OG006|Outcome|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
10800051|NCT02743871|OG000|Outcome|Part 1 Cohort 7: PF-06817024 30 mg SC SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
10800052|NCT02743871|OG002|Outcome|Part 1 Cohort 3: PF-06817024 100 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
10800053|NCT02743871|OG003|Outcome|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
10800054|NCT02743871|OG004|Outcome|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
11385665|NCT02040584|OG008|Outcome|25 to 29 Control Group|Control group (Treatment with TAC + MMF + corticosteroids) with MELD score 25 to 29
11385666|NCT02040584|OG009|Outcome|> = 30 Control Group|Control group (Treatment with TAC + MMF + corticosteroids) with MELD score > = 30
11385667|NCT02040584|EG000|Reported Event|Experimental Group|Minimisation of TAC: Treatment with rTAC+EVR+corticosteroids
11385668|NCT02040584|EG001|Reported Event|Control Group|Treatment with TAC + MMF + corticosteroids.
11385669|NCT02045797|BG000|Baseline|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
11385670|NCT02045797|BG001|Baseline|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
11385671|NCT02045797|BG002|Baseline|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
11385672|NCT02045797|BG003|Baseline|Total|Total of all reporting groups
11385673|NCT02045797|FG000|Participant Flow|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 milligrams (mg) intravenous (IV) every 12 hours (q12h; twice daily [BID]) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
11385674|NCT02045797|FG001|Participant Flow|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
11385675|NCT02045797|FG002|Participant Flow|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV every 8 hours (q8h) three times a day (TID) on Day 1 and Day 2 . Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
11385676|NCT02045797|OG000|Outcome|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
11385677|NCT02045797|OG001|Outcome|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
11385678|NCT02045797|OG002|Outcome|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
11385679|NCT02045797|EG000|Reported Event|Gepotidacin 750 mg q12h|Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
11385680|NCT02045797|EG001|Reported Event|Gepotidacin 1000 mg q12h|Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
10800055|NCT02743871|OG005|Outcome|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
11385681|NCT02045797|EG002|Reported Event|Gepotidacin 1000 mg q8h|Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
11385682|NCT02049710|BG000|Baseline|Sexual Behavior Intervention|Seventeen Days: Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception
11385683|NCT02049710|BG001|Baseline|Driving Behavior Intervention|Driving Skills for Life: Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.
11385684|NCT02049710|BG002|Baseline|Total|Total of all reporting groups
11385685|NCT02049710|FG000|Participant Flow|Sexual Behavior Intervention|Seventeen Days: Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception
11385686|NCT02049710|FG001|Participant Flow|Driving Behavior Intervention|Driving Skills for Life: Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.
11385687|NCT02049710|OG000|Outcome|Sexual Behavior Intervention|"Video based intervention based on changing risky behavior associated with sexual behavior.~Seventeen Days: Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception"
11385688|NCT02049710|OG001|Outcome|Driving Behavior Intervention|"Video based intervention based on changing risky behavior associate with driving~Driving Skills for Life: Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games."
11385689|NCT02049710|EG000|Reported Event|Sexual Behavior Intervention|Seventeen Days: Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception
11385690|NCT02049710|EG001|Reported Event|Driving Behavior Intervention|Driving Skills for Life: Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.
10800056|NCT02743871|OG007|Outcome|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
10800057|NCT02743871|OG008|Outcome|Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD|Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
11385691|NCT02055547|BG000|Baseline|Part 1 - 3, Panel A, B, C, D, E, F, and H|All participants who received a dose of MK-8521 or placebo in any study period.
11196868|NCT02168062|EG000|Reported Event|Arm I (Standard of Care)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11385692|NCT02055547|FG000|Participant Flow|Part 1 - Panel A - MK-8521 100μg > PBO|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and matching placebo (PBO) in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385693|NCT02055547|FG001|Participant Flow|Part 1 - Panel A - PBO > MK-8521 300μg|Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385694|NCT02055547|FG002|Participant Flow|Part 1 - Panel A - MK-8521 100μg > MK-8521 300μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385695|NCT02055547|FG003|Participant Flow|Part 1 - Panel B - MK-8521 150μg > PBO > MK-8521 175μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, PBO in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385696|NCT02055547|FG004|Participant Flow|Part 1 - Panel B - MK-8521 150μg > 200μg > MK-8521 175μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385697|NCT02055547|FG005|Participant Flow|Part 1 - Panel B - MK-8521 150μg > MK-8521 200μg > PBO|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385698|NCT02055547|FG006|Participant Flow|Part 1 - Panel B - PBO > MK-8521 200μg > MK-8521 175μg|Healthy male participants of 18 to 45 years of age received PBO in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385699|NCT02055547|FG007|Participant Flow|Part 2 - Panel C - MK-8521 50μg > MK-8521 72μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 50μg Days 1 to 5 and MK-8521 72μg Days 6 to 10 in a single treatment period.
11385700|NCT02055547|FG008|Participant Flow|Part 2 - Panel D - MK-8521 100μg > MK-8521 150μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
11385701|NCT02055547|FG009|Participant Flow|Part 2 - Panel E - MK-8521 125μg > MK-8521 150μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
11385702|NCT02055547|FG010|Participant Flow|Part 2 - Panels C, D, and E - Pooled PBO|Healthy young lean male participants received matching placebo for MK-8521 once daily for 10 days.
11385703|NCT02055547|FG011|Participant Flow|Part 2 - Panel F - MK-8521 72μg > MK-8521 125μg or PBO|Obese male participants of 45 to 65 years of age received a single dose of MK-8521 72μg Days 1 to 7 and MK-8521 125μg Days 8 to 14 or placebo in a single treatment period.
11385704|NCT02055547|FG012|Participant Flow|Part 2 - Panel F - Placebo|Obese male participants of 45 to 65 years of age received a single dose of matching placebo for MK-8521 Days 1 to 14.
11385705|NCT02055547|FG013|Participant Flow|Part 3 - Panel H - MK-8521 125μg > 35μg > PBO|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385706|NCT02055547|FG014|Participant Flow|Part 3 - Panel H - MK-8521 35μg > PBO > MK-8521 125μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, PBO in the second treatment period, and 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385707|NCT02055547|FG015|Participant Flow|Part 3 - Panel H - PBO > MK-8521 125μg > 35μg|Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385708|NCT02055547|FG016|Participant Flow|Part 3 - Panel H - PBO > MK-8521 35μg > 125μg|Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and MK-8521 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385709|NCT02055547|FG017|Participant Flow|Part 3 - Panel H - MK-8521 125μg > PBO > MK-8521 35μg|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, PBO in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385710|NCT02055547|FG018|Participant Flow|Part 3 - Panel H - MK-8521 35μg > 125μg > PBO|Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
11385711|NCT02055547|OG000|Outcome|Part 1 Panel A MK-8521 100μg|MK-8521 100μg in healthy male participants of 18 to 45 years of age
11385712|NCT02055547|OG001|Outcome|Part 1 Panel A MK-8521 300μg|MK-8521 300μg in healthy male participants of 18 to 45 years of age
10800058|NCT02743871|EG000|Reported Event|Part 1 Cohort 1: PF-06817024 10 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
10800059|NCT02743871|EG001|Reported Event|Part 1 Cohort 2: PF-06817024 30 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
10800060|NCT02743871|EG002|Reported Event|Part 1 Cohort 7: PF-06817024 30 mg SC SD|Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
10800061|NCT02743871|EG003|Reported Event|Part 1 Cohort 3: PF-06817024 100 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
11385713|NCT02055547|OG002|Outcome|Part 1 Panel B MK-8521 150μg|MK-8521 150μg in healthy male participants of 18 to 45 years of age
11385714|NCT02055547|OG003|Outcome|Part 1 Panel B MK-8521 175μg|MK-8521 175μg in healthy male participants of 18 to 45 years of age
11385715|NCT02055547|OG004|Outcome|Part 1 Panel B MK-8521 200μg|MK-8521 200μg in healthy male participants of 18 to 45 years of age
11385716|NCT02055547|OG005|Outcome|Part 1, Pooled Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385717|NCT02055547|OG000|Outcome|Part 2 Panel C MK-8521 50/72μg|MK-8521 50μg Days 1-5 and 72μg Days 6-10 or Placebo in healthy male participants of 18 to 45 years of age
10800062|NCT02743871|EG004|Reported Event|Part 1 Cohort 3: PF-06817024 100 mg IV MD|Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
10800063|NCT02743871|EG005|Reported Event|Part 1 Cohort 4: PF-06817024 300 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
11385718|NCT02055547|OG001|Outcome|Part 2 Panel D MK-8521 100/150μg|MK-8521 100μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
11385719|NCT02055547|OG002|Outcome|Part 2 Panel E MK-8521 125/150μg|MK-8521 125μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
10800064|NCT02743871|EG006|Reported Event|Part 1 Cohort 5: PF-06817024 1000 mg IV SD|Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
10800065|NCT02743871|EG007|Reported Event|Part 1: Placebo IV SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800066|NCT02743871|EG008|Reported Event|Part 1 Cohort 3: Placebo IV MD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
10800067|NCT02743871|EG009|Reported Event|Part 1 Cohort 7: Placebo SC SD|Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
10800068|NCT02743871|EG010|Reported Event|Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP|Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
11385720|NCT02055547|OG003|Outcome|Part 2 Panel F MK-8521 72/125μg|MK-8521 72μg Days 1-7 and 125μg Days 8-14 in obese male participants of 45 to 65 years of age
10800069|NCT02743871|EG011|Reported Event|Part 2 Cohort 8: Placebo IV CRSwNP|Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
10800070|NCT02743871|EG012|Reported Event|Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD|Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
10800071|NCT02743871|EG013|Reported Event|Part 3 Cohort 13: Placebo IV AD|Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
10800072|NCT02707198|BG000|Baseline|Group A|Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
10800073|NCT02707198|BG001|Baseline|Group B|"Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
10800074|NCT02707198|BG002|Baseline|Group C|"Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
11385721|NCT02055547|OG004|Outcome|Part 2, Pooled Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385722|NCT02055547|OG000|Outcome|Part 2 Panel F MK-8521 72/125μg|MK-8521 72μg Days 1-7 and 125μg Days 8-14 in obese male participants of 45 to 65 years of age
11385723|NCT02055547|OG000|Outcome|Part 2 Panel F MK-8521 72/125μgEdit|MK-8521 72μg Days 1-7 and 125μg Days 8-14 in obese male participants of 45 to 65 years of age
11385724|NCT02055547|OG000|Outcome|Part 3 Panel H MK-8521 35μg|MK-8521 35μg in healthy male participants of 18 to 45 years of age
11385725|NCT02055547|OG001|Outcome|Part 3 Panel H MK-8521 125μg|MK-8521 125μg in healthy male participants of 18 to 45 years of age
11385726|NCT02055547|OG002|Outcome|Part 3, Pooled Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385727|NCT02055547|OG005|Outcome|Part 1 - Pooled Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385728|NCT02055547|OG003|Outcome|Part 2 - Panel C, D, E - Pooled Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385729|NCT02055547|OG001|Outcome|Part 2 - Panel F - Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385730|NCT02055547|OG002|Outcome|Part 3 - Panel H - Placebo|Healthy male participants of 18 to 45 years of age received PBO.
11385731|NCT02055547|EG000|Reported Event|Part 1, Panel A, MK-8521 100μg|MK-8521 100μg in healthy male participants of 18 to 45 years of age
11385732|NCT02055547|EG001|Reported Event|Part 1, Panel A, MK-8521 300μg|MK-8521 300μg in healthy male participants of 18 to 45 years of age
11385733|NCT02055547|EG002|Reported Event|Part 1, Panel B, MK-8521 150μg|MK-8521 150μg in healthy male participants of 18 to 45 years of age
11385734|NCT02055547|EG003|Reported Event|Part 1, Panel B, MK-8521 175μg|MK-8521 175μg in healthy male participants of 18 to 45 years of age
11385735|NCT02055547|EG004|Reported Event|Part 1, Panel B, MK-8521 200μg|MK-8521 200μg in healthy male participants of 18 to 45 years of age
11385736|NCT02055547|EG005|Reported Event|Part 2, Panel C, MK-8521 50μg/72μg|MK-8521 50μg Days 1-5 and 72μg Days 6-10 or Placebo in healthy male participants of 18 to 45 years of age
11385737|NCT02055547|EG006|Reported Event|Part 2, Panel D, MK-8521 100μg/150μg|MK-8521 100μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
11385738|NCT02055547|EG007|Reported Event|Part 2, Panel E, MK-8521 125μg/150μg|MK-8521 125μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
11385739|NCT02055547|EG008|Reported Event|Part 2, Panel F, MK-8521 72μg/125μg|MK-8521 72μg Days 1-7 and 125μg Days 8-14 in obese male participants of 45 to 65 years of age
11385740|NCT02055547|EG009|Reported Event|Part 3, Panel H, MK-8521 35μg|MK-8521 35μg in healthy male participants of 18 to 45 years of age
11385741|NCT02055547|EG010|Reported Event|Part 3, Panel H, MK-8521 125μg|MK-8521 125μg in healthy male participants of 18 to 45 years of age
11385742|NCT02055547|EG011|Reported Event|Pooled Placebo|Placebo in healthy male participants of 18 to 45 years of age and obese male participants 45 to 65 years of age
10800075|NCT02707198|BG003|Baseline|Total|Total of all reporting groups
10800076|NCT02707198|FG000|Participant Flow|Group A|Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
11385743|NCT02064387|BG000|Baseline|Part 1: GSK2857916 0.03 mg/kg|Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385744|NCT02064387|BG001|Baseline|Part 1: GSK2857916 0.06 mg/kg|Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385745|NCT02064387|BG002|Baseline|Part 1: GSK2857916 0.12 mg/kg|Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385746|NCT02064387|BG003|Baseline|Part 1: GSK2857916 0.24 mg/kg|Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385747|NCT02064387|BG004|Baseline|Part 1: GSK2857916 0.48 mg/kg|Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385748|NCT02064387|BG005|Baseline|Part 1: GSK2857916 0.96 mg/kg|Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385749|NCT02064387|BG006|Baseline|Part 1: GSK2857916 1.92 mg/kg|Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385750|NCT02064387|BG007|Baseline|Part 1: GSK2857916 2.50 mg/kg|Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385751|NCT02064387|BG008|Baseline|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385752|NCT02064387|BG009|Baseline|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385753|NCT02064387|BG010|Baseline|Part 2: GSK2857916 3.40 mg/kg (MM)|Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
11385754|NCT02064387|BG011|Baseline|Part 2: GSK2857916 3.40 mg/kg (NHL)|Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
11385755|NCT02064387|BG012|Baseline|Total|Total of all reporting groups
11385756|NCT02064387|FG000|Participant Flow|Part 1: GSK2857916 0.03 mg/kg|Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385757|NCT02064387|FG001|Participant Flow|Part 1: GSK2857916 0.06 mg/kg|Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385758|NCT02064387|FG002|Participant Flow|Part 1: GSK2857916 0.12 mg/kg|Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385759|NCT02064387|FG003|Participant Flow|Part 1: GSK2857916 0.24 mg/kg|Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385760|NCT02064387|FG004|Participant Flow|Part 1: GSK2857916 0.48 mg/kg|Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385761|NCT02064387|FG005|Participant Flow|Part 1: GSK2857916 0.96 mg/kg|Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385762|NCT02064387|FG006|Participant Flow|Part 1: GSK2857916 1.92 mg/kg|Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385763|NCT02064387|FG007|Participant Flow|Part 1: GSK2857916 2.50 mg/kg|Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385764|NCT02064387|FG008|Participant Flow|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385765|NCT02064387|FG009|Participant Flow|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385766|NCT02064387|FG010|Participant Flow|Part 2: GSK2857916 3.40 mg/kg (MM)|Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
11385767|NCT02064387|FG011|Participant Flow|Part 2: GSK2857916 3.40 mg/kg (NHL)|Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
11385768|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.03 mg/kg|Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385769|NCT02064387|OG001|Outcome|Part 1: GSK2857916 0.06 mg/kg|Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385770|NCT02064387|OG002|Outcome|Part 1: GSK2857916 0.12 mg/kg|Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385771|NCT02064387|OG003|Outcome|Part 1: GSK2857916 0.24 mg/kg|Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385772|NCT02064387|OG004|Outcome|Part 1: GSK2857916 0.48 mg/kg|Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385773|NCT02064387|OG005|Outcome|Part 1: GSK2857916 0.96 mg/kg|Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385774|NCT02064387|OG006|Outcome|Part 1: GSK2857916 1.92 mg/kg|Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385775|NCT02064387|OG007|Outcome|Part 1: GSK2857916 2.50 mg/kg|Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385776|NCT02064387|OG008|Outcome|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385777|NCT02064387|OG009|Outcome|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385778|NCT02064387|OG000|Outcome|Part 2: GSK2857916 3.40 mg/kg (MM)|Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
11385779|NCT02064387|OG000|Outcome|Part 2: GSK2857916 3.40 mg/kg (NHL)|Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
11385780|NCT02064387|OG000|Outcome|Part 2: GSK2857916 3.40 mg/kg (NHL)|Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
11385781|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.06 mg/kg|Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385782|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.12 mg/kg|Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385783|NCT02064387|OG001|Outcome|Part 1: GSK2857916 0.03 mg/kg|Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385784|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.24 mg/kg|Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385785|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.48 mg/kg|Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385786|NCT02064387|OG000|Outcome|Part 1: GSK2857916 0.96 mg/kg|Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385787|NCT02064387|OG000|Outcome|Part 1: GSK2857916 1.92 mg/kg|Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385788|NCT02064387|OG000|Outcome|Part 1: GSK2857916 2.50 mg/kg|Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385789|NCT02064387|OG000|Outcome|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385790|NCT02064387|OG001|Outcome|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385791|NCT02064387|OG007|Outcome|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385792|NCT02064387|OG008|Outcome|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385793|NCT02064387|EG000|Reported Event|Part 1: GSK2857916 0.03 mg/kg|Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385794|NCT02064387|EG001|Reported Event|Part 1: GSK2857916 0.06 mg/kg|Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385795|NCT02064387|EG002|Reported Event|Part 1: GSK2857916 0.12 mg/kg|Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385796|NCT02064387|EG003|Reported Event|Part 1: GSK2857916 0.24 mg/kg|Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385797|NCT02064387|EG004|Reported Event|Part 1: GSK2857916 0.48 mg/kg|Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385798|NCT02064387|EG005|Reported Event|Part 1: GSK2857916 0.96 mg/kg|Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385799|NCT02064387|EG006|Reported Event|Part 1: GSK2857916 1.92 mg/kg|Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385800|NCT02064387|EG007|Reported Event|Part 1: GSK2857916 2.50 mg/kg|Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385801|NCT02064387|EG008|Reported Event|Part 1: GSK2857916 3.40 mg/kg|Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385802|NCT02064387|EG009|Reported Event|Part 1: GSK2857916 4.60 mg/kg|Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
11385803|NCT02064387|EG010|Reported Event|Part 2: GSK2857916 3.40 mg/kg (MM)|Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
11385804|NCT02064387|EG011|Reported Event|Part 2: GSK2857916 3.40 mg/kg (NHL)|Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
11385805|NCT02076178|BG000|Baseline|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
11385806|NCT02076178|BG001|Baseline|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
11385807|NCT02076178|BG002|Baseline|Total|Total of all reporting groups
11385808|NCT02076178|FG000|Participant Flow|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received intramuscular (IM) injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
11385809|NCT02076178|FG001|Participant Flow|Cabotegravir|Eligible participants received daily oral cabotegravir 30 milligrams (mg) tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
11385810|NCT02076178|OG000|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
11385811|NCT02076178|OG001|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
11385812|NCT02076178|OG000|Outcome|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12W intervals (W5, W17, and W29). The IM injection consisted of 800 mg of placebo.
11385813|NCT02076178|OG000|Outcome|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
11385814|NCT02076178|EG000|Reported Event|Placebo|Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
11385815|NCT02076178|EG001|Reported Event|Cabotegravir|Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
11385816|NCT02079766|BG000|Baseline|High Risk of CTE|Subjects at high risk of developing CTE (former National Football League players)
11385817|NCT02079766|BG001|Baseline|Controls|Former non-contact athletes
11385818|NCT02079766|BG002|Baseline|Total|Total of all reporting groups
11385819|NCT02079766|FG000|Participant Flow|High Risk of CTE|Subjects at high risk of developing CTE (chronic traumatic encephalopathy) - former National Football League players
11385820|NCT02079766|FG001|Participant Flow|Controls|Former non-contact athletes
11385821|NCT02079766|OG000|Outcome|High Risk of CTE|Subjects at high risk of developing CTE (former National Football League players)
11385822|NCT02079766|OG001|Outcome|Controls|Former non-contact athletes
11385823|NCT02079766|EG000|Reported Event|High Risk of CTE|Subjects at high risk of developing CTE (former National Football League players)
11385824|NCT02079766|EG001|Reported Event|Controls|Former non-contact athletes
11385825|NCT02081391|BG000|Baseline|Tapentadol (From 2 to <18 Years) - 12-h Treatm. Completion|"Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA.~This arm includes all participants aged 2 years to less than 18 years who received at least 1 dose of tapentadol oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours."
11385826|NCT02081391|BG001|Baseline|Placebo (From 2 to <18 Years) - 12-h Treatm. Completion|"Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA.~This arm includes all participants aged 2 years to less than 18 years who received at least 1 dose of placebo.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours."
11385827|NCT02081391|BG002|Baseline|Tapentadol (From Birth to <2 Years) - 12-h Treatm. Completion|"Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA.~This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who received at least 1 dose of tapentadol oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours."
11385828|NCT02081391|BG003|Baseline|Placebo (From Birth to <2 Years) - 12-h Treatm. Completion|"Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA.~This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who received at least 1 dose of placebo.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours."
11385829|NCT02081391|BG004|Baseline|Total|Total of all reporting groups
11385830|NCT02081391|FG000|Participant Flow|Tapentadol (From 2 to <18 Years)|"This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of tapentadol oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit."
11385831|NCT02081391|FG001|Participant Flow|Placebo (From 2 to <18 Years)|"This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of placebo oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit."
11385832|NCT02081391|FG002|Participant Flow|Tapentadol (From Birth to <2 Years)|"This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of tapentadol oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit."
11385833|NCT02081391|FG003|Participant Flow|Placebo (From Birth to <2 Years)|"This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of placebo oral solution.~12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit."
11385834|NCT02081391|OG000|Outcome|Tapentadol (From 2 to <18 Years)|This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
11385835|NCT02081391|OG001|Outcome|Placebo (From 2 to <18 Years)|This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
11385836|NCT02081391|OG002|Outcome|Tapentadol (From Birth to <2 Years)|This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
11385837|NCT02081391|OG003|Outcome|Placebo (From Birth to <2 Years)|This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
11385838|NCT02081391|OG000|Outcome|Tapentadol (From 2 to <6 Years)|This analysis subset included all participants aged 2 years to less than 6 years old who were allocated to tapentadol and received at least one dose of IMP.
11385839|NCT02081391|OG001|Outcome|Placebo (From 2 to <6 Years)|This analysis subset included all participants aged 2 years to less than 6 years old who were allocated to placebo and received at least one dose of IMP.
11385840|NCT02081391|OG000|Outcome|Tapentadol (6 to <12 Years)|This analysis subset included all participants aged 6 years to less than 12 years old who were allocated to tapentadol and received at least one dose of IMP.
11385841|NCT02081391|OG001|Outcome|Placebo (6 to <12 Years)|This analysis subset included all participants aged 6 years to less than 12 years old who were allocated to placebo and received at least one dose of IMP.
10800077|NCT02707198|FG001|Participant Flow|Group B|"Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
11385842|NCT02081391|OG000|Outcome|Tapentadol (12 to <18 Years)|This analysis subset included all participants aged 12 years to less than 18 years old who were allocated to Tapentadol and received at least one dose of IMP.
11385843|NCT02081391|OG001|Outcome|Placebo (12 to <18 Years)|This analysis subset included all participants aged 12 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
11385844|NCT02081391|OG000|Outcome|Tapentadol (From Birth to <2 Years)|This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
11385845|NCT02081391|OG001|Outcome|Placebo (From Birth to <2 Years)|This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
11385846|NCT02081391|EG000|Reported Event|Overall (From 2 to <18 Years)|All participants aged 2 years to below 18 years who received at least 1 dose of IMP.
11385847|NCT02081391|EG001|Reported Event|Tapentadol (From 2 to <18 Years)|All participants aged 2 years to below 18 years who received at least 1 dose of tapentadol oral solution.
11385848|NCT02081391|EG002|Reported Event|Placebo (From 2 to <18 Years)|All participants aged 2 years to below 18 years who received at least 1 dose of placebo oral solution.
11385849|NCT02081391|EG003|Reported Event|Overall (From Birth to <2 Years)|All participants from birth to below 2 years who received at least 1 dose of IMP.
11385850|NCT02081391|EG004|Reported Event|Tapentadol (From Birth to <2 Years)|All participants from birth to below 2 years who received at least 1 dose of tapentadol oral solution.
11385851|NCT02081391|EG005|Reported Event|Placebo (From Birth to <2 Years)|All participants from birth to below 2 years who received at least 1 dose of placebo oral solution.
11385852|NCT02087189|BG000|Baseline|ICD/ CRT-D Therapy With TD01 as ICD Lead|patients with TD01 as implanted ICD lead
11385853|NCT02087189|FG000|Participant Flow|ICD/ CRT-D Therapy With TD01 as ICD Lead|enrolled as a patient planned with ICD and TD01 implantation
11385854|NCT02087189|OG000|Outcome|ICD/ CRT-D Therapy With TD01 as ICD Lead|patients with TD01 as implanted ICD lead
11385855|NCT02087189|EG000|Reported Event|ICD/ CRT-D Therapy With TD01 as ICD Lead|patient with TD01 as implanted ICD lead
11385856|NCT02096055|BG000|Baseline|Arm I (Guadecitabine) x 5 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385857|NCT02096055|BG001|Baseline|Arm II (CLOSED) (Guadecitabine) x 10 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385858|NCT02096055|BG002|Baseline|Arm III (Guadecitabine, Idarubicin)|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC~Idarubicin: Given IV"
11385859|NCT02096055|BG003|Baseline|Arm IV (CLOSED) (Guadecitabine, Cladribine)|"INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Guadecitabine: Given SC"
11385860|NCT02096055|BG004|Baseline|Total|Total of all reporting groups
11385861|NCT02096055|FG000|Participant Flow|Arm I (Guadecitabine) x 5 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385862|NCT02096055|FG001|Participant Flow|Arm II (CLOSED) (Guadecitabine) x 10 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385863|NCT02096055|FG002|Participant Flow|Arm III (Guadecitabine, Idarubicin)|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC~Idarubicin: Given IV"
11385864|NCT02096055|FG003|Participant Flow|Arm IV (CLOSED) (Guadecitabine, Cladribine)|"INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Guadecitabine: Given SC"
11385865|NCT02096055|OG000|Outcome|Arm I (Guadecitabine) x 5 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
10800078|NCT02707198|FG002|Participant Flow|Group C|"Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
10800079|NCT02707198|OG000|Outcome|Group A|Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
11338004|NCT03599089|OG003|Outcome|Placebo|"Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~Placebo: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338005|NCT03599089|EG000|Reported Event|CA-008 0.7 mg (0.05 mg/mL Concentration)|"Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
10800080|NCT02707198|OG001|Outcome|Group B|"Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
11338006|NCT03599089|EG001|Reported Event|CA-008 2.1 mg (0.15 mg/mL Concentration)|"Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338007|NCT03599089|EG002|Reported Event|CA-008 4.2 mg (0.3 mg/mL Concentration)|"Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338008|NCT03599089|EG003|Reported Event|Placebo|"Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~Placebo: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338009|NCT03599193|BG000|Baseline|DFD-03 Lotion|"DFD-03 Lotion were applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study.~Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off"
11338010|NCT03599193|BG001|Baseline|Tazorac Cream|"Tazorac Cream were applied to the affected areas once daily and left on for ~12 hours. Twenty four (24) subjects were enrolled into this arm, of whom 21 completed the study.~Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours"
11338011|NCT03599193|BG002|Baseline|Total|Total of all reporting groups
11338012|NCT03599193|FG000|Participant Flow|DFD-03 Lotion|DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off.
11338013|NCT03599193|FG001|Participant Flow|Tazorac Cream|Tazorac Cream was applied to the affected areas once daily and left on for ~12 hours.
11338014|NCT03599193|OG000|Outcome|DFD-03 Lotion|"DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study.~Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off"
11338015|NCT03599193|OG001|Outcome|Tazorac Cream|"Tazorac Cream was applied to the affected areas once daily and left on for ~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study.~Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours"
11338016|NCT03599193|OG001|Outcome|Tazorac Cream|"Tazorac Cream will be applied to the affected areas once daily and left on for ~12 hours. Twenty four (24) subjects were enrolled into this arm, of whom 21 completed the study.~Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours"
11338017|NCT03599193|EG000|Reported Event|DFD-03 Lotion|"DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study.~Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off"
11338018|NCT03599193|EG001|Reported Event|Tazorac Cream|"Tazorac Cream was applied to the affected areas once daily and left on for ~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study.~Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours"
11338019|NCT03599271|BG000|Baseline|Randomized Cohort|"Randomized cohort (n=70) used a randomized intra-patient desgin which received Drug-Coated Device to dilate randomized frontal sinus ostium and control device in the randomized contralateral frontal sinus ostium.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug."
11338020|NCT03599271|BG001|Baseline|PK Cohort- Safety|"PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device."
11338021|NCT03599271|BG002|Baseline|Total|Total of all reporting groups
11338022|NCT03599271|FG000|Participant Flow|Randomized Cohort|"Randomized cohort (n=70) used a randomized intra-patient design in which the Drug-Coated Device was used to dilate randomized frontal sinus ostium and Control Device was used to dilate contralateral frontal sinus ostium.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug."
10800081|NCT02707198|OG002|Outcome|Group C|"Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
10800082|NCT02707198|EG000|Reported Event|Group A|Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
11338023|NCT03599271|FG001|Participant Flow|PK Cohort-Safety|"PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device."
11338024|NCT03599271|OG000|Outcome|Randomized Cohort - Treatment Arm|"Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device"
11338025|NCT03599271|OG001|Outcome|Randomized Cohort - Control Arm|"Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium.~Control Device: Sinus dilation device without drug"
11338026|NCT03599271|OG000|Outcome|PK Cohort-Safety|"PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device"
11338027|NCT03599271|OG000|Outcome|PK Cohort-Safety|"PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device."
11338028|NCT03599271|EG000|Reported Event|All Participants From Randomized Cohort|"Randomized cohort (n=70) used a randomized intra-patient design in which the Drug-Coated Device was used to dilate randomized frontal sinus ostium and Control Device was used to dilate contralateral frontal sinus ostium.~Each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events are reported per patient in the Randomized Cohort. The adverse events were not collected per intervention.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug."
11338029|NCT03599271|EG001|Reported Event|PK Cohort-Safety|"PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia.~Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device"
11338030|NCT03599349|BG000|Baseline|Microfocused Ultrasound w/ Visualization|Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
11338031|NCT03599349|FG000|Participant Flow|Microfocused Ultrasound w/ Visualization|Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
11338032|NCT03599349|OG000|Outcome|Microfocused Ultrasound w/ Visualization|Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
11338033|NCT03599349|EG000|Reported Event|Microfocused Ultrasound w/ Visualization|Subject were treated on the full-face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer). Ultrasound images were captured at the beginning, middle, and end of each treatment section during treatment.
11338034|NCT03599362|BG000|Baseline|Multi Agent Chemotherapy Cancer Patients|"Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.~Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.~Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used."
11338035|NCT03599362|FG000|Participant Flow|Multi Agent Chemotherapy Cancer Patients|"Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.~Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.~Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used."
11338036|NCT03599362|OG000|Outcome|Multi Agent Chemotherapy Cancer Patients|"Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.~Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.~Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used."
11338037|NCT03599362|EG000|Reported Event|Multi Agent Chemotherapy Cancer Patients|"Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.~Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.~Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used."
11338038|NCT03599687|BG000|Baseline|Group AAB|In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.
11338039|NCT03599687|BG001|Baseline|Group ABB|Participants randomised into making one pre-training and two post-training intubation attempts.
11385866|NCT02096055|OG001|Outcome|Arm II (CLOSED) (Guadecitabine) x 10 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385867|NCT02096055|OG002|Outcome|Arm III (Guadecitabine, Idarubicin)|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC~Idarubicin: Given IV"
11385868|NCT02096055|OG003|Outcome|Arm IV (CLOSED) (Guadecitabine, Cladribine)|"INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Guadecitabine: Given SC"
11385869|NCT02096055|EG000|Reported Event|Arm I (Guadecitabine) x 5 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385870|NCT02096055|EG001|Reported Event|Arm II (CLOSED) (Guadecitabine) x 10 Days|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC"
11385871|NCT02096055|EG002|Reported Event|Arm III (Guadecitabine, Idarubicin)|"INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Guadecitabine: Given SC~Idarubicin: Given IV"
11385872|NCT02096055|EG003|Reported Event|Arm IV (CLOSED) (Guadecitabine, Cladribine)|"INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.~MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Cladribine: Given IV~Guadecitabine: Given SC"
11385873|NCT02112916|BG000|Baseline|Arm A (Combination Chemotherapy): T-ALL|Patients receive combination chemotherapy without bortezomib.
11385874|NCT02112916|BG001|Baseline|Arm B (Combination Chemotherapy, Bortezomib): T-ALL|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11338040|NCT03599687|BG002|Baseline|Total|Total of all reporting groups
11338041|NCT03599687|FG000|Participant Flow|Group AAB|In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.
11338042|NCT03599687|FG001|Participant Flow|Group ABB|Participants randomised into making one pre-training and two post-training intubation attempts.
11338043|NCT03599687|OG000|Outcome|Group AAB|In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.
11338044|NCT03599687|OG001|Outcome|Group ABB|Participants randomised into making one pre-training and two post-training intubation attempts.
11338045|NCT03599687|EG000|Reported Event|Group AAB|In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.
11338046|NCT03599687|EG001|Reported Event|Group ABB|Participants randomised into making one pre-training and two post-training intubation attempts.
11338047|NCT03599986|BG000|Baseline|Single Arm|Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months.
11338048|NCT03599986|FG000|Participant Flow|Single Arm|Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months.
11338049|NCT03599986|OG000|Outcome|Single Arm|Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months.
11338050|NCT03599986|OG000|Outcome|Single Arm|Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed for 9 months.
11338051|NCT03599986|EG000|Reported Event|Single Arm|Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months.
11338052|NCT03600194|BG000|Baseline|Screening Population|All participants that were consented.
11338053|NCT03600194|FG000|Participant Flow|All Participants Consented|All participants consented to the study but not enter into the In-lab phase.
11338054|NCT03600194|FG001|Participant Flow|PowerSleep First, Northwestern Second|"Participants in this arm received the PowerSleep device first and the Northwestern device second. Participants were randomized to receive PowerSleep Stim or Sham first. Participants and study staff were blinded to assignment. In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device. T~PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.~PowerSleep Sham: the same device as stim with audio turned off."
11338055|NCT03600194|FG002|Participant Flow|Northwestern First, PowerSleep Second|"In this arm participants were randomized to received Stim or Sham of the Northwestern device first and the PowerSleep device second. The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used.~Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard polysomnogram (PSG) electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals.~Northwestern Sham: Exact same set-up as the stim version but with audio tones turned off."
11338056|NCT03600194|OG000|Outcome|PowerSleep Stim|"In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device.~PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time."
11385875|NCT02112916|BG002|Baseline|Arm A (Combination Chemotherapy): T-LLy|Patients receive combination chemotherapy without bortezomib.
11338068|NCT03600376|FG000|Participant Flow|Ryanodex and Standard of Care|"In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.~Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push"
11338069|NCT03600376|FG001|Participant Flow|Standard of Care Only (SOC)|"Standard of Care treatment will consist of the immediate start of cooling measures.~Standard of Care: Body cooling measures and supportive measures"
11338070|NCT03600376|OG000|Outcome|Ryanodex and Standard of Care|"In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.~Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push"
11338071|NCT03600376|OG001|Outcome|Standard of Care Only (SOC)|"Standard of Care treatment will consist of the immediate start of cooling measures.~Standard of Care: Body cooling measures and supportive measures"
11338072|NCT03600376|EG000|Reported Event|Ryanodex and Standard of Care|"In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.~Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push"
11338073|NCT03600376|EG001|Reported Event|Standard of Care Only (SOC)|"Standard of Care treatment will consist of the immediate start of cooling measures.~Standard of Care: Body cooling measures and supportive measures"
11338074|NCT03600428|BG000|Baseline|Live Attenuated Influenza Vaccine (LAIV4)|"Participants will receive one dose of quadrivalent live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)).~Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration"
11338075|NCT03600428|BG001|Baseline|Inactivated Influenza Vaccine (IIV4)|"Participants will receive one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).~Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration"
11338076|NCT03600428|BG002|Baseline|Total|Total of all reporting groups
11338077|NCT03600428|FG000|Participant Flow|Live Attenuated Influenza Vaccine (LAIV4)|"Participants will receive one dose of quadrivalent live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)).~Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration"
11338078|NCT03600428|FG001|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Participants will receive one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).~Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration"
11338079|NCT03600428|OG000|Outcome|Live Attenuated Influenza Vaccine (LAIV4)|"Participants received one dose of quadrivalent live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)).~Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration"
11338080|NCT03600428|OG001|Outcome|Inactivated Influenza Vaccine (IIV4)|"Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).~Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration"
11338081|NCT03600428|EG000|Reported Event|Live Attenuated Influenza Vaccine (LAIV4)|"Participants received one dose of quadrivalent live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)).~Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration"
11338082|NCT03600428|EG001|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).~Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration"
11338083|NCT03601052|BG000|Baseline|Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound|Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.
11338084|NCT03601052|FG000|Participant Flow|Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound|Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.
11338085|NCT03601052|OG000|Outcome|Remlarsen-Treated Excisional Skin Wound|Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.
11338086|NCT03601052|OG001|Outcome|Placebo-Treated Excisional Skin Wound|Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.
11338087|NCT03601052|OG000|Outcome|Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound|Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.
11338088|NCT03601052|OG000|Outcome|Remlarsen-Treated Excisional Skin Wound|"Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.~Remlarsen: Intradermal injection at site of one excisional wound"
11338089|NCT03601052|OG001|Outcome|Placebo-Treated Excisional Skin Wound|"Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control.~Placebo: Intradermal injection at site of second excisional wound"
11338090|NCT03601052|EG000|Reported Event|Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events|All subjects; all treatment-emergent adverse events, excluding wound or injection site-related events
11385876|NCT02112916|BG003|Baseline|Arm B (Combination Chemotherapy, Bortezomib): T-LLy|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385877|NCT02112916|BG004|Baseline|Total|Total of all reporting groups
11385878|NCT02112916|FG000|Participant Flow|Arm A (Combination Chemotherapy): T-ALL|Patients receive combination chemotherapy without bortezomib.
11385879|NCT02112916|FG001|Participant Flow|Arm B (Combination Chemotherapy, Bortezomib): T-ALL|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385880|NCT02112916|FG002|Participant Flow|Arm A (Combination Chemotherapy): T-LLy|Patients receive combination chemotherapy without bortezomib.
11385881|NCT02112916|FG003|Participant Flow|Arm B (Combination Chemotherapy, Bortezomib): T-LLy|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385882|NCT02112916|OG000|Outcome|Arm A (Combination Chemotherapy)|Patients receive combination chemotherapy without bortezomib.
11385883|NCT02112916|OG001|Outcome|Arm B (Combination Chemotherapy, Bortezomib)|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385884|NCT02112916|OG000|Outcome|Total Patients|All the eligible patients enrolled on the study
10800083|NCT02707198|EG001|Reported Event|Group B|"Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
11196869|NCT02168062|EG001|Reported Event|Arm II (STAND Clinic)|"Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.~Behavioral Dietary Intervention: Receive individualized nutrition counseling~Counseling: Receive individualized symptom management service counseling~Educational Intervention: Review educational modules~Exercise Intervention: Receive individualized exercise counseling~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given SC or IM~Quality-of-Life Assessment: Ancillary studies~Triptorelin Pamoate: Given IM"
11196870|NCT02168062|EG002|Reported Event|Non-Randomized Pilot Cohort|A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
11196871|NCT02168101|BG000|Baseline|MLN9708 - 2.3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
10800084|NCT02707198|EG002|Reported Event|Group C|"Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.~kefir: 4 ounces of kefir 3 times a day, with or without food."
11196872|NCT02168101|BG001|Baseline|MLN9708 - 3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196873|NCT02168101|BG002|Baseline|MLN9708 - 4 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196874|NCT02168101|BG003|Baseline|Total|Total of all reporting groups
11385885|NCT02112916|OG000|Outcome|AALL1231 T-ALL Patients|T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
11385886|NCT02112916|OG001|Outcome|AALL0434 T-ALL Patients|T-ALL patients on AALL0434 [NCT00408005] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD >0.1%);
11385887|NCT02112916|OG000|Outcome|VHR T-ALL MRD Undetectable|VHR T-ALL patients (with end of consolidation [EOC] MRD >= 0.1%) who become MRD negative (MRD undetectable) after the three high-risk BFM blocks of therapy
11385888|NCT02112916|OG001|Outcome|VHR T-ALL MRD Detectable|VHR T-ALL patients (with end of consolidation [EOC] MRD >= 0.1%) who continue to have detectable MRD after the three high-risk BFM blocks of therapy.
11385889|NCT02112916|OG000|Outcome|VHR T-LLy (CR/PR)|VHR T-LLy patients who achieved complete or partial response (CR/PR) at the end of the high-risk blocks
11385890|NCT02112916|OG001|Outcome|VHR T-LLy (NR)|VHR T-LLy patients who did not respond (NR) at the end of the high-risk blocks
11385891|NCT02112916|EG000|Reported Event|Arm A (Combination Chemotherapy): T-ALL|Patients receive combination chemotherapy without bortezomib.
11385892|NCT02112916|EG001|Reported Event|Arm B (Combination Chemotherapy, Bortezomib): T-ALL|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385893|NCT02112916|EG002|Reported Event|Arm A (Combination Chemotherapy): T-LLy|Patients receive combination chemotherapy without bortezomib.
11385894|NCT02112916|EG003|Reported Event|Arm B (Combination Chemotherapy, Bortezomib): T-LLy|Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
11385895|NCT02114697|BG000|Baseline|Lifestyle Modification|Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
11385896|NCT02114697|BG001|Baseline|Statin Therapy|Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
11385897|NCT02114697|BG002|Baseline|Total|Total of all reporting groups
11385898|NCT02114697|FG000|Participant Flow|Lifestyle Modification|Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
11385899|NCT02114697|FG001|Participant Flow|Statin Therapy|Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
11385900|NCT02114697|OG000|Outcome|Lifestyle Modification|Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
11196875|NCT02168101|FG000|Participant Flow|MLN9708 - 2.3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196876|NCT02168101|FG001|Participant Flow|MLN9708 - 3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11385901|NCT02114697|OG001|Outcome|Statin Therapy|Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
11385902|NCT02114697|EG000|Reported Event|Lifestyle Modification|Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
11385903|NCT02114697|EG001|Reported Event|Statin Therapy|Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
10800085|NCT02673398|BG000|Baseline|Treatment (Neratinib)|"Patients receive neratinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Comprehensive Geriatric Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~Neratinib: Given PO~Pharmacological Study: Correlative studies"
11196877|NCT02168101|FG002|Participant Flow|MLN9708 - 4 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196878|NCT02168101|OG000|Outcome|MLN9708 - 2.3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196879|NCT02168101|OG001|Outcome|MLN9708 - 3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196880|NCT02168101|OG002|Outcome|MLN9708 - 4 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196881|NCT02168101|OG000|Outcome|MLN9708 Combined Dose Escalation|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of either 2.3, 3, or 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11338091|NCT03601052|EG001|Reported Event|Wound or Injection Site-related Treatment-emergent Adverse Events|All subjects; wound or injection site-related treatment-emergent adverse events
11338092|NCT03601715|BG000|Baseline|Coplanar First, Then Contraplanar and at Last Longitudinal|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Coplanar arrangement application, then, after a washout period of at least one day received Contraplanar application and after a washout period of at least one day received Longitudinal application.
11338093|NCT03601715|BG001|Baseline|Contraplanar First, Then Coplanar and at Last Longitudinal|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Contraplanar arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Longitudinal application.
11338094|NCT03601715|BG002|Baseline|Longitudinal First, Then Coplanar and at Last Contraplanar|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Longitudinal arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Contraplanar application.
11338095|NCT03601715|BG003|Baseline|Total|Total of all reporting groups
11338096|NCT03601715|FG000|Participant Flow|Coplanar First, Then Contraplanar and at Last Longitudinal|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Coplanar arrangement application, then, after a washout period of at least one day received Contraplanar application and after a washout period of at least one day received Longitudinal application.
11338097|NCT03601715|FG001|Participant Flow|Contraplanar First, Then Coplanar and at Last Longitudinal|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Contraplanar arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Longitudinal application.
11338098|NCT03601715|FG002|Participant Flow|Longitudinal First, Then Coplanar and at Last Contraplanar|After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Longitudinal arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Contraplanar application.
11338099|NCT03601715|OG000|Outcome|Coplanar|"Electrode placed as far apart as the cross-sectional diameter of the pad electrode on the same aspect of the right tight.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338100|NCT03601715|OG001|Outcome|Contraplanar|"Electrode placed over opposite aspects in the right tight centre.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338101|NCT03601715|OG002|Outcome|Longitudinal|"Each electrode is placed at the final portion of the limb in opposite aspects of the right tight.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338102|NCT03601715|EG000|Reported Event|Coplanar|"Electrode placed as far apart as the cross-sectional diameter of the pad electrode on the same aspect of the right tight.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338103|NCT03601715|EG001|Reported Event|Contraplanar|"Electrode placed over opposite aspects in the right tight centre.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338104|NCT03601715|EG002|Reported Event|Longitudinal|"Each electrode is placed at the final portion of the limb in opposite aspects of the right tight.~After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject."
11338105|NCT03602053|BG000|Baseline|ROTAVAC 5D®|ROTAVAC 5D® administered at 6, 10 and 14 weeks of age.
11338106|NCT03602053|BG001|Baseline|ROTAVAC®|ROTAVAC® administered at 6, 10 and 14 weeks of age.
11338107|NCT03602053|BG002|Baseline|Rotarix®|Rotarix® administered at 6 and 10 weeks of age.
11338108|NCT03602053|BG003|Baseline|Total|Total of all reporting groups
11338109|NCT03602053|FG000|Participant Flow|ROTAVAC 5D®|ROTAVAC 5D® administered at 6, 10 and 14 weeks of age.
11338110|NCT03602053|FG001|Participant Flow|ROTAVAC®|ROTAVAC® administered at 6, 10 and 14 weeks of age.
11338111|NCT03602053|FG002|Participant Flow|Rotarix®|Rotarix® administered at 6 and 10 weeks of age.
11338112|NCT03602053|OG000|Outcome|ROTAVAC 5D®|ROTAVAC 5D® administered at 6, 10 and 14 weeks of age.
11338113|NCT03602053|OG001|Outcome|ROTAVAC®|ROTAVAC® administered at 6, 10 and 14 weeks of age.
11338114|NCT03602053|OG001|Outcome|ROTAVAC®|ROTAVAC ® administered at 6, 10 and 14 weeks of age.
11338115|NCT03602053|OG002|Outcome|Rotarix®|Rotarix® administered at 6 and 10 weeks of age.
11338116|NCT03602053|OG002|Outcome|Rotarix®|Rotarix® administered at6 and 10 weeks of age
11338117|NCT03602053|OG000|Outcome|ROTAVAC 5D®|ROTAVAC 5D® administered at 6,10 and14 weeks of age.
11338118|NCT03602053|OG001|Outcome|ROTAVAC®|ROTAVAC® administered at 6,10 and14 weeks of age.
11338119|NCT03602053|EG000|Reported Event|ROTAVAC 5D®|ROTAVAC 5D® administered at 6, 10 and 14 weeks of age.
11196882|NCT02168101|EG000|Reported Event|MLN9708 - 2.3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196883|NCT02168101|EG001|Reported Event|MLN9708 - 3 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11196884|NCT02168101|EG002|Reported Event|MLN9708 - 4 mg|Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
11338120|NCT03602053|EG001|Reported Event|ROTAVAC®|ROTAVAC® administered at 6, 10 and 14 weeks of age.
11338121|NCT03602053|EG002|Reported Event|Rotarix®|Rotarix® administered at 6 and 10 weeks of age.
11338122|NCT03602339|BG000|Baseline|Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW|Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
11338123|NCT03602339|FG000|Participant Flow|Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW|Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
11338124|NCT03602339|OG000|Outcome|Gadoterate 0.1 mmol/kg BW|Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.
11338125|NCT03602339|OG001|Outcome|Gadobutrol 0.075 mmol/kg BW|Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
11338126|NCT03602339|OG000|Outcome|Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW|Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
11338127|NCT03602339|EG000|Reported Event|Gadobutrol 0.075 mmol/kg BW|Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
11338128|NCT03602339|EG001|Reported Event|Gadoterate 0.1 mmol/kg BW|Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.
11338129|NCT03602482|BG000|Baseline|POTS|Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted were enrolled
11338130|NCT03602482|BG001|Baseline|Control|Healthy volunteers that were free of chronic illness were enrolled
11338131|NCT03602482|BG002|Baseline|Total|Total of all reporting groups
11338132|NCT03602482|FG000|Participant Flow|POTS- Supine First, Then Standing|Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
11338133|NCT03602482|FG001|Participant Flow|POTS- Standing First, Then Supine|Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
11338134|NCT03602482|FG002|Participant Flow|Controls- Supine First, Then Standing|Healthy volunteers with no chronic or systemic illness, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
11338135|NCT03602482|FG003|Participant Flow|Controls- Standing First, Then Supine|Healthy volunteers with no chronic or systemic illness, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
11338136|NCT03602482|OG000|Outcome|POTS- Supine, Standing|Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
11338137|NCT03602482|OG001|Outcome|POTS- Standing, Supine|Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
11338138|NCT03602482|OG002|Outcome|Control- Supine, Standing|Healthy volunteers that were free of chronic illness. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
11338139|NCT03602482|OG003|Outcome|Control- Standing, Supine|Healthy volunteers, free of chronic illness. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
11338140|NCT03602482|OG000|Outcome|POTS|POTS participants completed a screening for hypermobile EDS
11338141|NCT03602482|OG000|Outcome|POTS|Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted.
11338142|NCT03602482|OG001|Outcome|Control-|Healthy volunteers that were free of chronic illness.
11338143|NCT03602482|EG000|Reported Event|POTS- Supine|Participants previously diagnosed with postural tachycardia syndrome age 13-60 years. Participants completed supine testing first, then standing.
11338144|NCT03602482|EG001|Reported Event|Control- Supine|Healthy volunteers with no chronic/systemic illness age 13-60 years. Participants completed supine testing first, then standing.
11338145|NCT03602482|EG002|Reported Event|POTS- Standing|Participants previously diagnosed with postural tachycardia syndrome age 13-60 years. Participants completed standing testing first, then supine.
11338146|NCT03602482|EG003|Reported Event|Control- Standing|Healthy volunteers with no chronic/systemic illness age 13-60 years.Participants completed standing testing first, then supine.
11338147|NCT03603028|BG000|Baseline|Exergaming|Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
11338148|NCT03603028|FG000|Participant Flow|Exergaming|Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
11338149|NCT03603028|OG000|Outcome|Exergaming|Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
11338150|NCT03603028|EG000|Reported Event|Exergaming|Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
11338151|NCT03603106|BG000|Baseline|Part I (Phase I) P03277 0.025 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11385904|NCT02134717|BG000|Baseline|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
11385905|NCT02134717|FG000|Participant Flow|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
11385906|NCT02134717|OG000|Outcome|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
11385907|NCT02134717|EG000|Reported Event|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.~all subjects will receive maraviroc 300mg orally twice a day for 6 weeks~Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.~venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.~Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
11385908|NCT02135029|BG000|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385909|NCT02135029|BG001|Baseline|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11196885|NCT02168153|BG000|Baseline|Chiropractic Manipulative Therapy|"Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.~Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture."
11385910|NCT02135029|BG002|Baseline|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
11385911|NCT02135029|BG003|Baseline|Total|Total of all reporting groups
11385912|NCT02135029|FG000|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385913|NCT02135029|FG001|Participant Flow|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385914|NCT02135029|FG002|Participant Flow|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
11385915|NCT02135029|OG000|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
10965817|NCT00884117|OG000|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11196886|NCT02168153|BG001|Baseline|Wait-List Control Group|"Participants will complete questionnaires and biomechanical assessments~Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits."
11196887|NCT02168153|BG002|Baseline|Total|Total of all reporting groups
11385916|NCT02135029|OG001|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385917|NCT02135029|OG002|Outcome|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
11385918|NCT02135029|OG000|Outcome|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385919|NCT02135029|EG000|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385920|NCT02135029|EG001|Reported Event|PF-04950615 150 Milligram (mg) + Placebo|Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.
11385921|NCT02135029|EG002|Reported Event|Atorvastatin 40 mg + Placebo|Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
11196888|NCT02168153|FG000|Participant Flow|Chiropractic Manipulative Therapy|"Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.~Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture."
10800086|NCT02673398|FG000|Participant Flow|Treatment (Neratinib)|"Patients receive neratinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Comprehensive Geriatric Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~Neratinib: Given PO~Pharmacological Study: Correlative studies"
11196889|NCT02168153|FG001|Participant Flow|Wait-List Control Group|"Participants will complete questionnaires and biomechanical assessments~Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits."
11338152|NCT03603106|BG001|Baseline|Part I (Phase I) P03277 0.05 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11338153|NCT03603106|BG002|Baseline|Part I (Phase I) P03277 0.075 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11338154|NCT03603106|BG003|Baseline|Part I (Phase I) P03277 0.1 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11338155|NCT03603106|BG004|Baseline|Part I (Phase I) P03277 0.2 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11338156|NCT03603106|BG005|Baseline|Part I (Phase I) P03277 0.3 mmol/kg|"6 subjects received P03277 in one single administration.~P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s."
11338157|NCT03603106|BG006|Baseline|Part I (Phase I) Placebo|"3 healthy subjects per dose group received placebo in one single administration.~Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s."
11338158|NCT03603106|BG007|Baseline|Part II (Phase IIA) P03277 0.05 mmol/kg|"3 patients received one single administration of P03277.~P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s."
11338159|NCT03603106|BG008|Baseline|Part II (Phase IIA) P03277 0.075 mmol/kg|"3 patients received one single administration of P03277.~P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s."
11338160|NCT03603106|BG009|Baseline|Part II (Phase IIA) P03277 0.1 mmol/kg|"3 patients received one single administration of P03277.~P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s."
11338161|NCT03603106|BG010|Baseline|Part II (Phase IIA) P03277 0.2 mmol/kg|"3 patients received one single administration of P03277.~P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s."
11338162|NCT03603106|BG011|Baseline|Total|Total of all reporting groups
11338163|NCT03603106|FG000|Participant Flow|Part I (Phase I) P03277 0.025 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338164|NCT03603106|FG001|Participant Flow|Part I (Phase I) P03277 0.05 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338165|NCT03603106|FG002|Participant Flow|Part I (Phase I) P03277 0.075 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338166|NCT03603106|FG003|Participant Flow|Part I (Phase I) P03277 0.1 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338167|NCT03603106|FG004|Participant Flow|Part I (Phase I) P03277 0.2 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338168|NCT03603106|FG005|Participant Flow|Part I (Phase I) P03277 0.3 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338169|NCT03603106|FG006|Participant Flow|Part I (Phase I) Placebo|"3 healthy subjects per dose group received placebo in one single administration.~Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s."
11338170|NCT03603106|FG007|Participant Flow|Part II (Phase IIA) P03277 0.05 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
11338171|NCT03603106|FG008|Participant Flow|Part II (Phase IIA) P03277 0.075 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
11338172|NCT03603106|FG009|Participant Flow|Part II (Phase IIA) P03277 0.1 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
11338173|NCT03603106|FG010|Participant Flow|Part II (Phase IIA) P03277 0.2 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
11338174|NCT03603106|OG000|Outcome|Part I (Phase I) P03277 0.025 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338175|NCT03603106|OG001|Outcome|Part I (Phase I) P03277 0.05 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338176|NCT03603106|OG002|Outcome|Part I (Phase I) P03277 0.075 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338177|NCT03603106|OG003|Outcome|Part I (Phase I) P03277 0.1 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338178|NCT03603106|OG004|Outcome|Part I (Phase I) P03277 0.2 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338179|NCT03603106|OG005|Outcome|Part I (Phase I) P03277 0.3 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338180|NCT03603106|OG006|Outcome|Part II (Phase IIA) 0.05 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
11338181|NCT03603106|OG007|Outcome|Part II (Phase IIA) 0.075 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
11338182|NCT03603106|OG008|Outcome|Part II (Phase IIA) 0.1 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
11338183|NCT03603106|OG009|Outcome|Part II (Phase IIA) 0.2 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
11196890|NCT02168153|OG000|Outcome|Chiropractic Manipulative Therapy|"Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.~Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture."
11196891|NCT02168153|OG001|Outcome|Wait-List Control Group|"Participants will complete questionnaires and biomechanical assessments~Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits."
11196892|NCT02168153|EG000|Reported Event|Chiropractic Manipulative Therapy|"Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.~Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture."
11196893|NCT02168153|EG001|Reported Event|Wait-List Control Group|"Participants will complete questionnaires and biomechanical assessments~Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits."
11196894|NCT02168309|BG000|Baseline|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
11196895|NCT02168309|BG001|Baseline|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
11196896|NCT02168309|BG002|Baseline|Total|Total of all reporting groups
11196897|NCT02168309|FG000|Participant Flow|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
11196898|NCT02168309|FG001|Participant Flow|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
11196899|NCT02168309|OG000|Outcome|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
11196900|NCT02168309|OG001|Outcome|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
11196901|NCT02168309|EG000|Reported Event|Labetalol|"Labetalol 200mg PO BID starting dose~Labetalol: Titrate up for blood pressure control"
11196902|NCT02168309|EG001|Reported Event|Nifedipine|"Nifedpine XL starting at dose 30mg PO daily~Nifedipine: Titrate up to achieve blood pressure control"
11196903|NCT02168361|BG000|Baseline|Oral Therapy Arm|
11196904|NCT02168361|BG001|Baseline|Interferon-containing Arm|
11196905|NCT02168361|BG002|Baseline|Total|Total of all reporting groups
11196906|NCT02168361|FG000|Participant Flow|All Oral Therapy|Simeprevir-sofosbuvir
11196907|NCT02168361|FG001|Participant Flow|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
11196908|NCT02168361|OG000|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
11196909|NCT02168361|OG001|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
11196910|NCT02168361|EG000|Reported Event|All Oral|
11196911|NCT02168361|EG001|Reported Event|Interferon-containing|
11196912|NCT02168387|BG000|Baseline|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
11196913|NCT02168387|BG001|Baseline|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
11196914|NCT02168387|BG002|Baseline|Total|Total of all reporting groups
11196915|NCT02168387|FG000|Participant Flow|Medication|"Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.~Acetylcysteine~dornase alfa"
11196916|NCT02168387|FG001|Participant Flow|Continuous High Frequency Oscillator (CHFO)|"Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.~continuous high frequency oscillator (CHFO)"
11196917|NCT02168387|OG000|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
11196918|NCT02168387|OG001|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
11196919|NCT02168387|EG000|Reported Event|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
11196920|NCT02168387|EG001|Reported Event|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
11196921|NCT02168439|BG000|Baseline|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: ."
11196922|NCT02168439|BG001|Baseline|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: ."
11196923|NCT02168439|BG002|Baseline|Total|Total of all reporting groups
11196924|NCT02168439|FG000|Participant Flow|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
11196925|NCT02168439|FG001|Participant Flow|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
11196926|NCT02168439|OG000|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
11196927|NCT02168439|OG001|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
11196928|NCT02168439|EG000|Reported Event|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
11196929|NCT02168439|EG001|Reported Event|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
11196930|NCT02168478|BG000|Baseline|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae."
11196931|NCT02168478|FG000|Participant Flow|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Saline is applied to the absorbent pad portion of a"
11196932|NCT02168478|OG000|Outcome|Patch Test Group|"Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours."
11196933|NCT02168478|EG000|Reported Event|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.~Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae."
11196934|NCT02168491|BG000|Baseline|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
11196935|NCT02168491|FG000|Participant Flow|Lixisenatide With Basal Insulin (LixiBIT)|"Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide~Lixisenatide: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.~Insulin glargine: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of"
11196936|NCT02168491|OG000|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
11196937|NCT02168491|EG000|Reported Event|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
11196938|NCT02168660|BG000|Baseline|Control Group|"Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196939|NCT02168660|BG001|Baseline|Low-Normal Group|"Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11338184|NCT03603106|OG000|Outcome|Part I (Phase I) P03277 0.025 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11385922|NCT02137239|BG000|Baseline|Treatment A|BELA + EVL
11196940|NCT02168660|BG002|Baseline|High-Normal Group|"Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196941|NCT02168660|BG003|Baseline|Total|Total of all reporting groups
11196942|NCT02168660|FG000|Participant Flow|Control Group|"Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196943|NCT02168660|FG001|Participant Flow|Low-Normal Group|"Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196944|NCT02168660|FG002|Participant Flow|High-Normal Group|"Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196945|NCT02168660|OG000|Outcome|Control Group|"Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196946|NCT02168660|OG001|Outcome|Low-Normal Group|"Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196947|NCT02168660|OG002|Outcome|High-Normal Group|"Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196948|NCT02168660|OG000|Outcome|Control Group|"Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI z-score, 25-OH D level.~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196949|NCT02168660|OG001|Outcome|Low-Normal Group|"Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI z-score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196950|NCT02168660|OG002|Outcome|High-Normal Group|"Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI z-score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196951|NCT02168660|EG000|Reported Event|Control Group|"Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196952|NCT02168660|EG001|Reported Event|Low-Normal Group|"Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196953|NCT02168660|EG002|Reported Event|High-Normal Group|"Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).~Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL."
11196954|NCT02168777|BG000|Baseline|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
11196955|NCT02168777|BG001|Baseline|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
11196956|NCT02168777|BG002|Baseline|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
11196957|NCT02168777|BG003|Baseline|Total|Total of all reporting groups
11196958|NCT02168777|FG000|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
11385923|NCT02137239|BG001|Baseline|Treatment B|TAC + MMF
11385924|NCT02137239|BG002|Baseline|Total|Total of all reporting groups
11385925|NCT02137239|FG000|Participant Flow|Treatment A|BELA + EVL
11196959|NCT02168777|FG001|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
11196960|NCT02168777|FG002|Participant Flow|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
11196961|NCT02168777|OG000|Outcome|Ph1b-Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
11196962|NCT02168777|OG001|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
11196963|NCT02168777|OG002|Outcome|Ph1b-Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
11196964|NCT02168777|OG000|Outcome|Ph2 - Refametinib/Regorafenib (CRC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be metastatic colorectal cancer (CRC).
11196965|NCT02168777|OG001|Outcome|Ph2 - Refametinib/Regorafenib (NSCLC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be non-small-cell lung cancer (NSCLC).
11196966|NCT02168777|OG002|Outcome|Ph2 - Refametinib/Regorafenib (BC)|Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC).
11196967|NCT02168777|EG000|Reported Event|Ph1b - Refametinib/Regorafenib Cohort 0|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off.
11196968|NCT02168777|EG001|Reported Event|Ph1b - Refametinib/Regorafenib Cohort -1|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off.
11196969|NCT02168777|EG002|Reported Event|Ph1b - Refametinib/Regorafenib Cohort -1a|Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
11196970|NCT02168803|BG000|Baseline|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
11196971|NCT02168803|BG001|Baseline|Evacetrapib: Multiple Dose 24 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
11196972|NCT02168803|BG002|Baseline|Evacetrapib: Multiple Dose 52 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
11196973|NCT02168803|BG003|Baseline|Total|Total of all reporting groups
11196974|NCT02168803|FG000|Participant Flow|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12 consecutive weeks.
11196975|NCT02168803|FG001|Participant Flow|Evacetrapib: Multiple Dose 24 Weeks|130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 24 consecutive weeks.
11196976|NCT02168803|FG002|Participant Flow|Evacetrapib: Multiple Dose 52 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
11196977|NCT02168803|OG000|Outcome|Evacetrapib: Single Dose, All Participants|A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
11196978|NCT02168803|OG001|Outcome|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
11196979|NCT02168803|OG002|Outcome|Evacetrapib: Multiple Dose 24 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
11196980|NCT02168803|OG003|Outcome|Evacetrapib: Multiple Dose 52 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
11196981|NCT02168803|OG001|Outcome|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
11196982|NCT02168803|OG000|Outcome|Evacetrapib: Single, Multiple Dose 12, 24, and 52 Weeks|A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
11196983|NCT02168803|OG000|Outcome|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
11196984|NCT02168803|OG001|Outcome|Evacetrapib: Multiple Dose 24 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
11196985|NCT02168803|OG002|Outcome|Evacetrapib: Multiple Dose 52 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
11196986|NCT02168803|EG000|Reported Event|Evacetrapib: Single Dose, All Participants|A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
11385926|NCT02137239|FG001|Participant Flow|Treatment B|TAC + MMF
11385927|NCT02137239|OG000|Outcome|Treatment A|BELA + EVL
11385928|NCT02137239|OG001|Outcome|Treatment B|TAC + MMF
11385929|NCT02137239|EG000|Reported Event|BELA+EVL|BELA + EVL
11385930|NCT02137239|EG001|Reported Event|TAC+MMF|TAC + MMF
11196987|NCT02168803|EG001|Reported Event|Evacetrapib: Multiple Dose 12 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
11196988|NCT02168803|EG002|Reported Event|Evacetrapib: Multiple Dose 24 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
11196989|NCT02168803|EG003|Reported Event|Evacetrapib: Multiple Dose 52 Weeks|130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
11196990|NCT02168816|BG000|Baseline|Intravenous Antibacterial Agent|Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
11196991|NCT02168816|BG001|Baseline|Oral Antibacterial Agent|Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
11196992|NCT02168816|BG002|Baseline|Total|Total of all reporting groups
11196993|NCT02168816|FG000|Participant Flow|Oral Antibacterial Agent|Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
11196994|NCT02168816|FG001|Participant Flow|Intravenous Antibacterial Agent|Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
11196995|NCT02168816|OG000|Outcome|Intravenous Antibacterial Agent|Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
11196996|NCT02168816|OG001|Outcome|Oral Antibacterial Agent|Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
11196997|NCT02168816|EG000|Reported Event|Intravenous Antibacterial Agent|Individuals in this arm were randomized to an intravenous antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
11196998|NCT02168816|EG001|Reported Event|Oral Antibacterial Agent|Individuals in this arm were randomized to an oral antibacterial agent. They were not assigned to specific medications. Instead, individuals in this arm received an oral antibacterial agent as determined by their primary healthcare provider. This therapy was usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
11196999|NCT02168842|BG000|Baseline|Isradipine|"Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.~Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily"
11197000|NCT02168842|BG001|Baseline|Placebo (for Isradipine)|"Oral capsule taken twice daily for 36 months.~Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients"
11197001|NCT02168842|BG002|Baseline|Total|Total of all reporting groups
11197002|NCT02168842|FG000|Participant Flow|Isradipine|Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
11197003|NCT02168842|FG001|Participant Flow|Placebo (for Isradipine)|Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
11197004|NCT02168842|OG000|Outcome|Isradipine|"Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.~Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily"
11197005|NCT02168842|OG001|Outcome|Placebo (for Isradipine)|"Oral capsule taken twice daily for 36 months.~Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients"
11197006|NCT02168842|OG000|Outcome|Isradipine|Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
11197007|NCT02168842|OG001|Outcome|Placebo (for Isradipine)|Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
11197008|NCT02168842|EG000|Reported Event|Isradipine|"Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.~Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily"
11197009|NCT02168842|EG001|Reported Event|Placebo (for Isradipine)|"Oral capsule taken twice daily for 36 months.~Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients"
11197010|NCT02168855|BG000|Baseline|Active Nicotine Gum|"active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum~Standard behavioral therapy: Standard behavioral therapy for smoking cessation"
11197011|NCT02168855|BG001|Baseline|Inactive Gum|Standard behavioral therapy: Standard behavioral therapy for smoking cessation
11197012|NCT02168855|BG002|Baseline|Total|Total of all reporting groups
11197013|NCT02168855|FG000|Participant Flow|Active Nicotine Gum|"active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum~Standard behavioral therapy: Standard behavioral therapy for smoking cessation"
11197014|NCT02168855|FG001|Participant Flow|Inactive Gum|Standard behavioral therapy: Standard behavioral therapy for smoking cessation
11197015|NCT02168855|OG000|Outcome|Active Nicotine Gum|"active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum~Standard behavioral therapy: Standard behavioral therapy for smoking cessation"
11197016|NCT02168855|OG001|Outcome|Inactive Gum|Standard behavioral therapy: Standard behavioral therapy for smoking cessation
11197017|NCT02168855|OG000|Outcome|Inactive Gum|Momentary real-time report of situational and mood and craving factors, randomly assessed throughout the day, at times not associated with smoking, use of other nicotine products, temptation to smoke, or use of gum
11197018|NCT02168855|OG000|Outcome|Background|Momentary real-time report of situational and mood and craving factors, randomly assessed throughout the day, at times not associated with smoking, use of other nicotine products, temptation to smoke, or use of gum
11197019|NCT02168855|EG000|Reported Event|Active Nicotine Gum|"active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum~Standard behavioral therapy: Standard behavioral therapy for smoking cessation"
11197020|NCT02168855|EG001|Reported Event|Inactive Gum|Standard behavioral therapy: Standard behavioral therapy for smoking cessation
11197021|NCT02168933|BG000|Baseline|All Study Participants|"all study participants received 308 nm excimer laser treatment to one hand and sham laser to the other hand.~308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks"
11197022|NCT02168933|FG000|Participant Flow|All Study Participants|"all participants received 308 nm excimer laser treatment on one hand, and sham laser treatment on the other hand~308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks"
11197023|NCT02168933|OG000|Outcome|Active|"308 nm excimer laser treatment~308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks~308 nm excimer laser: Laser to the non-control side"
11197024|NCT02168933|OG001|Outcome|Sham|"Sham laser treatment.~Sham laser: Biweekly treatments with Sham laser for a total of 8 weeks.~Sham laser: Sham laser treatment to the control side (308 nm excimer laser with cover in place preventing patient from exposure to laser energy)."
11197025|NCT02168933|OG000|Outcome|Active|"308 nm excimer laser treatment~308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks"
11197026|NCT02168933|OG001|Outcome|Sham|"Sham 308 nm excimer laser treatment~Sham laser: Sham laser treatment to the control side."
11385931|NCT02148133|BG000|Baseline|Eltrombopag|Subjects were assigned the investigational product (eltrombopag 25 mg/day) orally once a day under fasting condition. The dose adjustment was done every 2 weeks according to the platelet count (increased by eltrombopag 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day).
11385932|NCT02148133|FG000|Participant Flow|Eltrombopag|Subjects were assigned the investigational product (eltrombopag 25 mg/day) orally once a day under fasting condition. The dose adjustment was done every 2 weeks according to the platelet count (increased by eltrombopag 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day).
11385933|NCT02148133|OG000|Outcome|Eltrombopag|Subjects were assigned the investigational product (eltrombopag 25 mg/day) orally once a day under fasting condition. The dose adjustment was done every 2 weeks according to the platelet count (increased by eltrombopag 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day).
11197027|NCT02168933|EG000|Reported Event|Active|"308 nm excimer laser treatment~308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks"
11197028|NCT02168933|EG001|Reported Event|Sham|"Sham laser treatment (laser covered with cap so that the patient is not exposed to laser energy)~Sham laser: Biweekly treatments with Sham laser for a total of 8 weeks"
11197029|NCT02168946|BG000|Baseline|Vabomere|Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
11197030|NCT02168946|BG001|Baseline|Best Available Therapy|Best Available Therapy: Antibiotic(s) chosen by Investigator
11197031|NCT02168946|BG002|Baseline|Total|Total of all reporting groups
11197032|NCT02168946|FG000|Participant Flow|Vabomere|"Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days~Vabomere: Vabomere for IV injection, administered as a 2 g/2 g dose"
11197033|NCT02168946|FG001|Participant Flow|Best Available Therapy|"Subjects will receive Best Available Therapy (IV antibiotics)~Best Available Therapy: Antibiotic(s) chosen by Investigator"
11197034|NCT02168946|OG000|Outcome|Vabomere|Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
11197035|NCT02168946|OG001|Outcome|Best Available Therapy|Best Available Therapy: Antibiotic(s) chosen by Investigator
11197036|NCT02168946|EG000|Reported Event|Vabomere|Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
11197037|NCT02168946|EG001|Reported Event|Best Available Therapy|Best Available Therapy: Antibiotic(s) chosen by Investigator
11197038|NCT02169115|BG000|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11197039|NCT02169115|BG001|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11197040|NCT02169115|BG002|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
11197041|NCT02169115|BG003|Baseline|Total|Total of all reporting groups
11197042|NCT02169115|FG000|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11197043|NCT02169115|FG001|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11385934|NCT02148133|EG000|Reported Event|Eltrombopag|Subjects were assigned the investigational product (eltrombopag 25 mg/day) orally once a day under fasting condition. The dose adjustment was done every 2 weeks according to the platelet count (increased by eltrombopag 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day).
11197044|NCT02169115|FG002|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
11197045|NCT02169115|OG000|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11197046|NCT02169115|OG001|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11197047|NCT02169115|OG002|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
11197048|NCT02169115|OG002|Outcome|Placebo|Placebo: s.c., every 4 weeks
11197049|NCT02169115|EG000|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
11197050|NCT02169115|EG001|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
11197051|NCT02169115|EG002|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
11197052|NCT02169219|BG000|Baseline|Glucocorticoids and Rituximab|"This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.~Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.~Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2"
11197053|NCT02169219|FG000|Participant Flow|Glucocorticoids and Rituximab|All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
11197054|NCT02169219|OG000|Outcome|Glucocorticoids and Rituximab|"Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.~Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab will be administered in four weekly doses at 375mg/m2"
11197055|NCT02169219|OG000|Outcome|Rituximab and Glucocorticoids|"Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab administered in 4 weekly doses at 375 mg/m2"
11197056|NCT02169219|OG000|Outcome|Glucocorticoids and Rituximab|All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
11197057|NCT02169219|OG000|Outcome|Glucocorticoids and Rituximab|"Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.~Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2"
11338185|NCT03603106|OG001|Outcome|Part I (Phase I) P03277 0.05 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11338186|NCT03603106|OG002|Outcome|Part I (Phase I) P03277 0.075 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11338187|NCT03603106|OG003|Outcome|Part I (Phase I) P03277 0.1 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11338188|NCT03603106|OG004|Outcome|Part I (Phase I) P03277 0.2 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11338189|NCT03603106|OG005|Outcome|Part I (Phase I) P03277 0.3 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
11338190|NCT03603106|OG006|Outcome|Part II (Phase IIA) 0.05 mmol/kg|"In each dose group, all 3 patients received one single administration of P03277.~P03277 was administered intravenously with a flow rate of 2 mL/s."
11338191|NCT03603106|OG007|Outcome|Part II (Phase IIA) 0.075 mmol/kg|"In each dose group, all 3 patients received one single administration of P03277.~P03277 was administered intravenously with a flow rate of 2 mL/s."
11338192|NCT03603106|OG008|Outcome|Part II (Phase IIA) 0.1 mmol/kg|"In each dose group, all 3 patients received one single administration of P03277.~P03277 was administered intravenously with a flow rate of 2 mL/s."
11338193|NCT03603106|OG009|Outcome|Part II (Phase IIA) 0.2 mmol/kg|"In each dose group, all 3 patients received one single administration of P03277.~P03277 was administered intravenously with a flow rate of 2 mL/s."
11338194|NCT03603106|EG000|Reported Event|Part I (Phase I) P03277 0.025 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338195|NCT03603106|EG001|Reported Event|Part I (Phase I) P03277 0.05 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338196|NCT03603106|EG002|Reported Event|Part I (Phase I) P03277 0.075 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338197|NCT03603106|EG003|Reported Event|Part I (Phase I) P03277 0.1 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338198|NCT03603106|EG004|Reported Event|Part I (Phase I) P03277 0.2 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338199|NCT03603106|EG005|Reported Event|Part I (Phase I) P03277 0.3 mmol/kg|6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
11338200|NCT03603106|EG006|Reported Event|Part I (Phase I) Placebo|"3 healthy subjects per dose group received placebo in one single administration.~Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s."
11338201|NCT03603106|EG007|Reported Event|Part II (Phase IIA) P03277 0.05 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
11338202|NCT03603106|EG008|Reported Event|Part II (Phase IIA) P03277 0.075 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
11338203|NCT03603106|EG009|Reported Event|Part II (Phase IIA) P03277 0.1 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
11338204|NCT03603106|EG010|Reported Event|Part II (Phase IIA) P03277 0.2 mmol/kg|3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
11338205|NCT03603652|BG000|Baseline|Microwave Ablation|Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
11338206|NCT03603652|FG000|Participant Flow|Microwave Ablation|Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
11338207|NCT03603652|OG000|Outcome|Microwave Ablation|Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
11338208|NCT03603652|EG000|Reported Event|Microwave Ablation|Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
11338209|NCT03604263|BG000|Baseline|Treatment Arm|"Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter~ArcticLine Cardiac Cryoablation Catheter: Cryoablation"
11338210|NCT03604263|FG000|Participant Flow|Treatment Arm|"Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter~ArcticLine Cardiac Cryoablation Catheter: Cryoablation"
11338211|NCT03604263|OG000|Outcome|Treatment Arm|"Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter~ArcticLine Cardiac Cryoablation Catheter: Cryoablation"
11338212|NCT03604263|EG000|Reported Event|Treatment Arm|"Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter~ArcticLine Cardiac Cryoablation Catheter: Cryoablation"
11338213|NCT03604341|BG000|Baseline|Gestational Age up to 10w0d - Dronabinol|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain"
11338214|NCT03604341|BG001|Baseline|Gestational Age up to 10w0d - Placebo|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain"
11338215|NCT03604341|BG002|Baseline|Total|Total of all reporting groups
11385935|NCT02151383|BG000|Baseline|Serelaxin: Cohort 1|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 1, patients in age group of 6 to <18 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385936|NCT02151383|BG001|Baseline|Serelaxin: Cohort 2|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 2, patients in age group of 1 to <6 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385937|NCT02151383|BG002|Baseline|Serelaxin: Cohort 3|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 3, patients in age group of 1 month to <1 year were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. In this cohort, high- dose group was planned to receive twice the number of patients in low-dose group.
11385938|NCT02151383|BG003|Baseline|Total|Total of all reporting groups
11385939|NCT02151383|FG000|Participant Flow|Serelaxin: Cohort 1|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 1, patients in age group of 6 to <18 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385940|NCT02151383|FG001|Participant Flow|Serelaxin: Cohort 2|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 2, patients in age group of 1 to <6 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385941|NCT02151383|FG002|Participant Flow|Serelaxin: Cohort 3|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 3, patients in age group of 1 month to <1 year were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. In this cohort, high- dose group was planned to receive twice the number of patients in low-dose group.
11385942|NCT02151383|OG000|Outcome|Serelaxin: Cohort 1|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 1, patients in age group of 6 to <18 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385943|NCT02151383|OG001|Outcome|Serelaxin: Cohort 2|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 2, patients in age group of 1 to <6 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385944|NCT02151383|OG002|Outcome|Serelaxin: Cohort 3|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 3, patients in age group of 1 month to <1 year were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. In this cohort, high- dose group was planned to receive twice the number of patients in low-dose group.
11385945|NCT02151383|EG000|Reported Event|Serelaxin: Cohort 1|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 1, patients in age group of 6 to <18 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385946|NCT02151383|EG001|Reported Event|Serelaxin: Cohort 2|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 2, patients in age group of 1 to <6 years were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. Both the low-dose and high- dose groups were planned to receive equal number of patients.
11385947|NCT02151383|EG002|Reported Event|Serelaxin: Cohort 3|Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours. In Cohort 3, patients in age group of 1 month to <1 year were enrolled either into a low-dose or a high-dose group. During this 48-hour treatment period, the serelaxin dose rates to be administered were 3 μg/kg/day, 10 μg/kg/day and 30 μg/kg/day in the low -dose group; 10 μg/kg/day, 30 μg/kg/day and 100 μg/kg/day in the high-dose group. In this cohort, high- dose group was planned to receive twice the number of patients in low-dose group.
11385948|NCT02165215|BG000|Baseline|Open-Label Induction Phase: Etrolizumab|All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
11385949|NCT02165215|BG001|Baseline|Double-Blind Maintenance Phase: Etrolizumab|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
11385950|NCT02165215|BG002|Baseline|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385951|NCT02165215|BG003|Baseline|Total|Total of all reporting groups
11385952|NCT02165215|FG000|Participant Flow|Open-Label Induction Phase: Etrolizumab|All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
11385953|NCT02165215|FG001|Participant Flow|Double-Blind Maintenance Phase: Etrolizumab|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
11385954|NCT02165215|FG002|Participant Flow|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385955|NCT02165215|OG000|Outcome|Double-Blind Maintenance Phase: Etrolizumab|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
11385956|NCT02165215|OG001|Outcome|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385957|NCT02165215|OG000|Outcome|Open-Label Induction Phase: Etrolizumab|All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
11385958|NCT02165215|OG001|Outcome|Double-Blind Maintenance Phase: Etrolizumab|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
11385959|NCT02165215|OG002|Outcome|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385960|NCT02165215|OG000|Outcome|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385961|NCT02165215|EG000|Reported Event|Open-Label Induction Phase: Etrolizumab|All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
11385962|NCT02165215|EG001|Reported Event|Double-Blind Maintenance Phase: Etrolizumab|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
11385963|NCT02165215|EG002|Reported Event|Double-Blind Maintenance Phase: Placebo|Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
11385964|NCT02180217|BG000|Baseline|Osilodrostat (LCI699)|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then osilodrostat during a double-blind, placebo controlled RW Period.
11385965|NCT02180217|BG001|Baseline|LCI699 Placebo|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then placebo during a double-blind, placebo controlled RW Period.
11385966|NCT02180217|BG002|Baseline|Non-randomized|All participants in this group took open label osilodrostat, before and after randomization.
11385967|NCT02180217|BG003|Baseline|Total|Total of all reporting groups
11385968|NCT02180217|FG000|Participant Flow|Osilodrostat (LCI699)|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then osilodrostat during a double-blind, placebo controlled RW Period.
11385969|NCT02180217|FG001|Participant Flow|LCI699 Placebo|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then placebo during a double-blind, placebo controlled RW Period.
11385970|NCT02180217|FG002|Participant Flow|Non-randomized|All participants in this group took open label osilodrostat, before and after randomization.
11385971|NCT02180217|OG000|Outcome|Osilodrostat (LCI699)|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then osilodrostat during a double-blind, placebo controlled RW Period.
11385972|NCT02180217|OG001|Outcome|LCI699 Placebo|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then placebo during a double-blind, placebo controlled RW Period.
11385973|NCT02180217|OG000|Outcome|All Participants|Consisted of all participants who were enrolled and treated in the open label osilodrostat.
11385974|NCT02180217|OG002|Outcome|Non-randomized|All participants in this group took open label osilodrostat, before and after randomization.
11385975|NCT02180217|OG000|Outcome|All Participants|Consisted of all participants in the study under osilodrostat treatment
11385976|NCT02180217|OG000|Outcome|Osilodrostat (LCI699) 2 mg|Participants received 2mg of osilodrostat
11385977|NCT02180217|OG001|Outcome|Osilodrostat (LCI699) 3 mg|Participants received 3mg of osilodrostat
11385978|NCT02180217|OG002|Outcome|Osilodrostat (LCI699) 5 mg|Participants received 5 mg of osilodrostat
11385979|NCT02180217|OG003|Outcome|Osilodrostat (LCI699) 7 mg|Participants received 7 mg of osilodrostat
11385980|NCT02180217|EG000|Reported Event|Osilodrostat|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then osilodrostat during a double-blind, placebo controlled RW Period.
11385981|NCT02180217|EG001|Reported Event|LCI699 Placebo|Consisted of a single-arm, open-label, osilodrostat dose-titration in individual patients and then placebo during a double-blind, placebo controlled RW Period.
11385982|NCT02180217|EG002|Reported Event|Non-randomized|All participants in this group took open label osilodrostat, before and after randomization.
11385983|NCT02180217|EG003|Reported Event|All Participants|Consisted of all participants who were enrolled and treated with open label osilodrostat.
11385984|NCT02186457|BG000|Baseline|Polymyxin B in Normal Saline|"Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline~Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage"
11385985|NCT02186457|BG001|Baseline|Placebo: Normal Saline|"0.9 % Normal Saline~Placebo: Normal Saline: Placebo irrigation via peritoneal lavage"
11385986|NCT02186457|BG002|Baseline|Total|Total of all reporting groups
11385987|NCT02186457|FG000|Participant Flow|Polymyxin B in Normal Saline|"Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline~Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage"
11385988|NCT02186457|FG001|Participant Flow|Placebo: Normal Saline|"0.9 % Normal Saline~Placebo: Normal Saline: Placebo irrigation via peritoneal lavage"
11385989|NCT02186457|OG000|Outcome|Polymyxin B in Normal Saline|"Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline~Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage"
11385990|NCT02186457|OG001|Outcome|Placebo: Normal Saline|"0.9 % Normal Saline~Placebo: Normal Saline: Placebo irrigation via peritoneal lavage"
11385991|NCT02186457|EG000|Reported Event|Polymyxin B in Normal Saline|"Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline~Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage"
11385992|NCT02186457|EG001|Reported Event|Placebo: Normal Saline|"0.9 % Normal Saline~Placebo: Normal Saline: Placebo irrigation via peritoneal lavage"
11385993|NCT02193867|BG000|Baseline|Open-Label Sebelipase Alfa|All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
11385994|NCT02193867|FG000|Participant Flow|Open-Label Sebelipase Alfa|All participants initiated once weekly (qw) intravenous (IV) infusions with sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
11385995|NCT02193867|OG000|Outcome|Open-Label Sebelipase Alfa|All participants initiated qw IV infusions with sebelipase alfa at a dose of 1 mg/kg qw. A participant who met protocol defined dose escalation criteria at a dose of 1 mg/kg qw could be considered for a dose escalation to 3 mg/kg qw. If a participant continued to meet dose escalation criteria after at least 4 infusions at a dose of 3 mg/kg qw, the participant could be considered for a further dose escalation to 5 mg/kg qw. Under country-specific provisions (UK only), participants could be considered for a further dose escalation to 7.5 mg/kg qw if a thorough case review indicated that a participant continued to have evidence of disease progression at a dose of 5 mg/kg qw. All dose escalations were contingent upon acceptable safety and tolerability of preceding infusions and were undertaken by mutual agreement of the Investigator and Sponsor and after approval by an independent safety committee.
11385996|NCT02193867|EG000|Reported Event|Sebelipase Alfa: 1.0 mg/kg qw|This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw. All 10 participants in the FAS received sebelipase alfa at a dose of 1.0 mg/kg qw.
11385997|NCT02193867|EG001|Reported Event|Sebelipase Alfa: 3.0 mg/kg qw|This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw. Nine of the 10 participants in the FAS received sebelipase alfa at a dose of 3.0 mg/kg qw.
11385998|NCT02193867|EG002|Reported Event|Sebelipase Alfa: 5.0 mg/kg qw|This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 5.0 mg/kg qw. Seven of the 10 participants in the FAS received sebelipase alfa at a dose of 5.0 mg/kg qw.
11385999|NCT02193867|EG003|Reported Event|Sebelipase Alfa: 7.5 mg/kg qw|This reporting group is based on the FAS and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 7.5 mg/kg qw (UK only). One of the 10 participants in the FAS received sebelipase alfa at a dose of 7.5 mg/kg qw.
11386000|NCT02215096|BG000|Baseline|All Participants|Participant received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. In combination treatment period, participants received GSK2636771 200 mg or 300 mg or 400 mg once daily orally in combination with enzalutamide 160 mg once daily orally in dose escalation/ expansion cohorts.
11386001|NCT02215096|FG000|Participant Flow|Enzalutamide Only (run-in Period)|Participants received enzalutamide monotherapy at the approved dose of 160 milligrams (mg) once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.
11386002|NCT02215096|FG001|Participant Flow|GSK2636771 200mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386003|NCT02215096|FG002|Participant Flow|GSK2636771 200mg/Enzalutamide 160mg Expansion|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.
11386004|NCT02215096|FG003|Participant Flow|GSK2636771 300mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386005|NCT02215096|FG004|Participant Flow|GSK2636771 400mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386006|NCT02215096|OG000|Outcome|Enzalutamide Only (run-in Period)|Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.
11386007|NCT02215096|OG000|Outcome|GSK2636771 200mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386008|NCT02215096|OG001|Outcome|GSK2636771 200mg/Enzalutamide 160mg Expansion|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.
11386009|NCT02215096|OG002|Outcome|GSK2636771 300mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386010|NCT02215096|OG003|Outcome|GSK2636771 400mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386011|NCT02215096|OG000|Outcome|GSK2636771 200mg/Enzalutamide 160mg - Overall|Participants received GSK2636771 200 mg with enzalutamide 160 mg either in dose escalation cohort or in dose expansion cohort. This arm contain combined data for dose escalation and dose expansion cohorts of GSK2636771 200 mg/ Enzalutamide 160 mg.
11386012|NCT02215096|OG000|Outcome|GSK2636771 200mg/Enzalutamide 160mg Expansion|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.
11386013|NCT02215096|OG001|Outcome|GSK2636771 300mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386014|NCT02215096|OG002|Outcome|GSK2636771 400mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386015|NCT02215096|EG000|Reported Event|Enzalutamide Only (run-in Period)|Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the Enzalutamide run-in period continued with the combination therapy with GSK2636771.
11386016|NCT02215096|EG001|Reported Event|GSK2636771 200mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386017|NCT02215096|EG002|Reported Event|GSK2636771 200mg/Enzalutamide 160mg Expansion|Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.
10800087|NCT02673398|OG000|Outcome|Treatment (Neratinib)|"Patients receive neratinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Comprehensive Geriatric Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~Neratinib: Given PO~Pharmacological Study: Correlative studies"
11386018|NCT02215096|EG003|Reported Event|GSK2636771 300mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386019|NCT02215096|EG004|Reported Event|GSK2636771 400mg/Enzalutamide 160mg Escalation|Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
11386020|NCT02218697|BG000|Baseline|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
11386021|NCT02218697|BG001|Baseline|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
11386022|NCT02218697|BG002|Baseline|Total|Total of all reporting groups
11386023|NCT02218697|FG000|Participant Flow|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
11386024|NCT02218697|FG001|Participant Flow|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
11386025|NCT02218697|OG000|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
11386026|NCT02218697|OG001|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
11386027|NCT02218697|EG000|Reported Event|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
11386028|NCT02218697|EG001|Reported Event|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
11386029|NCT02221037|BG000|Baseline|Placebo (BAL Collapsed Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386030|NCT02221037|BG001|Baseline|Placebo (BAL Ventilated Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386031|NCT02221037|BG002|Baseline|GSK2862277 26 mg (BAL Collapsed Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386032|NCT02221037|BG003|Baseline|GSK2862277 26 mg (BAL Ventilated Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386033|NCT02221037|BG004|Baseline|Total|Total of all reporting groups
11386034|NCT02221037|FG000|Participant Flow|Placebo (BAL Collapsed Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung broncho-alveolar lavage (BAL) procedure on Day 1.
11386035|NCT02221037|FG001|Participant Flow|Placebo (BAL Ventilated Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386036|NCT02221037|FG002|Participant Flow|GSK2862277 26 mg (BAL Collapsed Lung)|Eligible participants received a single dose of GSK2862277 26 milligrams (mg) on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386037|NCT02221037|FG003|Participant Flow|GSK2862277 26 mg (BAL Ventilated Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386038|NCT02221037|OG000|Outcome|Placebo (BAL Collapsed Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386039|NCT02221037|OG001|Outcome|Placebo (BAL Ventilated Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386040|NCT02221037|OG002|Outcome|GSK2862277 26 mg (BAL Collapsed Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386041|NCT02221037|OG003|Outcome|GSK2862277 26 mg (BAL Ventilated Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386042|NCT02221037|OG000|Outcome|GSK2862277 26 mg (BAL Collapsed Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386043|NCT02221037|OG001|Outcome|GSK2862277 26 mg (BAL Ventilated Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386044|NCT02221037|OG000|Outcome|Placebo (Pooling BAL Collapsed and Ventilated Lungs)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent either collapsed lung BAL procedure or ventilated lung BAL procedure on Day 1.
11386045|NCT02221037|OG001|Outcome|GSK2862277 26 mg (Pooling BAL Collapsed and Ventilated Lungs)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent either collapsed lung BAL procedure or ventilated lung BAL procedure on Day 1.
11386046|NCT02221037|EG000|Reported Event|Placebo (BAL Collapsed Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386047|NCT02221037|EG001|Reported Event|Placebo (BAL Ventilated Lung)|Eligible participants received a single dose of matching placebo on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386048|NCT02221037|EG002|Reported Event|GSK2862277 26 mg (BAL Collapsed Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent collapsed lung BAL procedure on Day 1.
11386049|NCT02221037|EG003|Reported Event|GSK2862277 26 mg (BAL Ventilated Lung)|Eligible participants received a single dose of GSK2862277 26 mg on Day 1 via oral inhalation route over approximately 3 to 5 minutes; approximately 1 to 3 hours prior to scheduled surgery. After surgery, participants in this arm underwent ventilated lung BAL procedure on Day 1.
11386050|NCT02224456|BG000|Baseline|Tenofovir Disoproxil Fumarate 300 mg|Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
11386051|NCT02224456|FG000|Participant Flow|Tenofovir Disoproxil Fumarate 300 mg|Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
11386052|NCT02224456|OG000|Outcome|Tenofovir Disoproxil Fumarate 300 mg|Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
11386053|NCT02224456|EG000|Reported Event|Tenofovir Disoproxil Fumarate 300 mg|Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
11386054|NCT02231762|BG000|Baseline|Combination Phase|"All subjects received lanreotide ATG 120 mg plus temozolomide in combination for 6 months.~Subjects received 1 injection of lanreotide ATG 120 mg and temozolomide capsules for 5 consecutive days, in a 28 day treatment cycle. The temozolomide dose was adapted to the subject body surface area (BSA) and the dose in the 1st treatment cycle was 150 mg/metres squared (m^2) per day. Depending on the safety laboratory values, the temozolomide dose was increased to 200 mg/m^2 per day from cycle 2 to cycle 6."
11386055|NCT02231762|FG000|Participant Flow|Combination Phase|"All subjects received lanreotide ATG 120 mg plus temozolomide in combination for 6 months.~Subjects received 1 injection of lanreotide ATG 120 mg and temozolomide capsules for 5 consecutive days, in a 28 day treatment cycle. The temozolomide dose was adapted to the subject body surface area (BSA) and the dose in the 1st treatment cycle was 150 mg/metres squared (m^2) per day. Depending on the safety laboratory values, the temozolomide dose was increased to 200 mg/m^2 per day from cycle 2 to cycle 6."
11386056|NCT02231762|FG001|Participant Flow|Maintenance Phase - Functioning NET, Lanreotide|In case of clinical benefit, defined as either complete response (CR), partial response (PR) or stable disease (SD) after the first 6 months combination phase, all subjects with functioning (serotonin producing) NET continued to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386057|NCT02231762|FG002|Participant Flow|Maintenance Phase - Non-functioning NET, Lanreotide|Following completion of the 6-month combination phase, all subjects with non-functioning NET and clinical benefit were randomised to continue to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386058|NCT02231762|FG003|Participant Flow|Maintenance Phase - Non-functioning NET, No Treatment|Following completion of the 6-month combination phase, all subjects with non-functioning NET and clinical benefit were randomised to receive no treatment for 6 months. This maintenance phase started with visit 8, week 24.
11386059|NCT02231762|OG000|Outcome|Combination Phase|"All subjects received lanreotide ATG 120 mg plus temozolomide in combination for 6 months.~Subjects received 1 injection of lanreotide ATG 120 mg and temozolomide capsules for 5 consecutive days, in a 28 day treatment cycle. The temozolomide dose was adapted to the subject body surface area (BSA) and the dose in the 1st treatment cycle was 150 mg/metres squared (m^2) per day. Depending on the safety laboratory values, the temozolomide dose was increased to 200 mg/m^2 per day from cycle 2 to cycle 6."
11386060|NCT02231762|OG000|Outcome|Maintenance Phase - Functioning NET, Lanreotide|In case of clinical benefit, defined as either complete response (CR), partial response (PR) or stable disease (SD) after the first 6 months combination phase, all subjects with functioning (serotonin producing) NET continued to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386061|NCT02231762|OG001|Outcome|Maintenance Phase - Non-functioning NET, Lanreotide|After the first 6 months combination phase, subjects with non-functioning NET and clinical benefit were randomised to continue to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386062|NCT02231762|OG002|Outcome|Maintenance Phase - Non-functioning NET, No Treatment|After the first 6 months combination phase, subjects with non-functioning NET and clinical benefit were randomised to receive no treatment for 6 months. This maintenance phase started with visit 8, week 24.
11386063|NCT02231762|OG000|Outcome|Intention-to-treat (ITT) Population|All treated subjects having at least one baseline and at least one post baseline assessment of the primary efficacy parameter.
11386064|NCT02231762|OG000|Outcome|Combination Phase - Functioning NET|All subjects in the combination phase who were categorised at baseline as having functioning NET.
11386065|NCT02231762|OG000|Outcome|Combination Phase|"All subjects received lanreotide ATG 120 mg plus temozolomide in combination for 6 months.~Subjects received 1 injection of lanreotide ATG 120 mg and temozolomide capsules for 5 consecutive days, in a 28 day treatment cycle. The temozolomide dose was adapted to the subject body surface area (BSA) and the dose in the 1st treatment cycle was 150 mg/metres squared (m^2) per day. Depending on the safety laboratory values, the temozolomide dose was increased to 200 mg/m^2 per day from cycle 2 to cycle 6"
11386066|NCT02231762|OG000|Outcome|PK Subset|All subjects for whom PK assessments were performed and with evaluable PK data.
11386067|NCT02231762|EG000|Reported Event|Combination Phase|"All subjects received lanreotide ATG 120 mg plus temozolomide in combination for 6 months.~Subjects received 1 injection of lanreotide ATG 120 mg and temozolomide capsules for 5 consecutive days, in a 28 day treatment cycle. The temozolomide dose was adapted to the subject body surface area (BSA) and the dose in the 1st treatment cycle was 150 mg/metres squared (m^2) per day. Depending on the safety laboratory values, the temozolomide dose was increased to 200 mg/m^2 per day from cycle 2 to cycle 6."
11386068|NCT02231762|EG001|Reported Event|Maintenance Phase - Functioning NET, Lanreotide|In case of clinical benefit, defined as either CR, PR or SD, after the first 6 months combination phase all subjects with functioning NET continued to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386069|NCT02231762|EG002|Reported Event|Maintenance Phase - Non-functioning NET, Lanreotide|Following completion of the 6-month combination phase, all subjects with non-functioning NET and clinical benefit were randomised to continue to receive lanreotide ATG 120 mg for another 6 months. This maintenance phase started with visit 8, week 24.
11386070|NCT02231762|EG003|Reported Event|Maintenance Phase - Non-functioning NET, No Treatment|Following completion of the 6-month combination phase, all subjects with non-functioning NET and clinical benefit were randomised to receive no treatment for 6 months. This maintenance phase started with visit 8, week 24.
11386071|NCT02234843|BG000|Baseline|Rivaroxaban, Aged 12-<18|Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
11386072|NCT02234843|BG001|Baseline|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386073|NCT02234843|BG002|Baseline|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386074|NCT02234843|BG003|Baseline|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386075|NCT02234843|BG004|Baseline|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386076|NCT02234843|BG005|Baseline|Comparator, Aged 12-<18|Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386077|NCT02234843|BG006|Baseline|Comparator, Aged 6-<12|Children aged 6-<12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386078|NCT02234843|BG007|Baseline|Comparator, Aged 2-<6|Children aged 2-<6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386079|NCT02234843|BG008|Baseline|Comparator, Aged 0.5-<2|Children aged 0.5-<2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386080|NCT02234843|BG009|Baseline|Comparator, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386081|NCT02234843|BG010|Baseline|Total|Total of all reporting groups
11386082|NCT02234843|FG000|Participant Flow|Rivaroxaban, Aged 12-<18|Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
11241357|NCT02486406|EG001|Reported Event|Adult Tablet, 12-17 yr, Part 2|Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
11241358|NCT02486406|EG002|Reported Event|Adult Tablet, 12-17 yr, Total|Participants age 12-17 years old who received at least one dose of the adult formulation
11386083|NCT02234843|FG001|Participant Flow|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386084|NCT02234843|FG002|Participant Flow|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386085|NCT02234843|FG003|Participant Flow|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386086|NCT02234843|FG004|Participant Flow|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386087|NCT02234843|FG005|Participant Flow|Comparator, Aged 12-<18|Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to Vitamin K Antagonist (VKA) therapy. VKA dosages were adjusted to maintain the international normalized ratio (INR) within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386088|NCT02234843|FG006|Participant Flow|Comparator, Aged 6-<12|Children aged 6-<12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386089|NCT02234843|FG007|Participant Flow|Comparator, Aged 2-<6|Children aged 2-<6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386090|NCT02234843|FG008|Participant Flow|Comparator, Aged 0.5-<2|Children aged 0.5-<2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386091|NCT02234843|FG009|Participant Flow|Comparator, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386092|NCT02234843|OG000|Outcome|Rivaroxaban Group|Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386093|NCT02234843|OG001|Outcome|Comparator Group|Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart
11386094|NCT02234843|OG000|Outcome|Rivaroxaban, Aged 12-<18|Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
11386095|NCT02234843|OG001|Outcome|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386096|NCT02234843|OG002|Outcome|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386097|NCT02234843|OG003|Outcome|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386098|NCT02234843|OG004|Outcome|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386099|NCT02234843|OG005|Outcome|Comparator, Aged 12-<18|Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386100|NCT02234843|OG006|Outcome|Comparator, Aged 6-<12|Children aged 6-<12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386101|NCT02234843|OG007|Outcome|Comparator, Aged 2-<6|Children aged 2-<6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386102|NCT02234843|OG008|Outcome|Comparator, Aged 0.5-<2|Children aged 0.5-<2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386103|NCT02234843|OG009|Outcome|Comparator, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386104|NCT02234843|OG001|Outcome|Comparator, Aged 12-<18|Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386105|NCT02234843|OG002|Outcome|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386106|NCT02234843|OG003|Outcome|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386107|NCT02234843|OG004|Outcome|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386108|NCT02234843|OG005|Outcome|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386109|NCT02234843|OG001|Outcome|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386110|NCT02234843|OG002|Outcome|Comparator, Aged 12-<18|Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386111|NCT02234843|OG003|Outcome|Comparator, Aged 0.5-<2|Children aged 0.5-<2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386112|NCT02234843|OG004|Outcome|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386113|NCT02234843|OG005|Outcome|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386114|NCT02234843|OG006|Outcome|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386115|NCT02234843|OG007|Outcome|Comparator, Aged 6-<12|Children aged 6-<12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386116|NCT02234843|OG008|Outcome|Comparator, Aged 2-<6|Children aged 2-<6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
11386117|NCT02234843|OG000|Outcome|Rivaroxaban, Aged 6-<12|Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386118|NCT02234843|OG000|Outcome|Rivaroxaban, Aged 2-<6|Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386119|NCT02234843|OG000|Outcome|Rivaroxaban, Aged 0.5-<2|Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386120|NCT02234843|OG000|Outcome|Rivaroxaban, Aged Birth-<0.5|Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386121|NCT02234843|EG000|Reported Event|Comparator Group|Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart
11386122|NCT02234843|EG001|Reported Event|Rivaroxaban Group|Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
11386123|NCT02243306|BG000|Baseline|Participants Undergoing CAPD|Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.
11386124|NCT02243306|BG001|Baseline|Participants Undergoing APD|Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.
11386125|NCT02243306|BG002|Baseline|Total|Total of all reporting groups
11386126|NCT02243306|FG000|Participant Flow|Participants Undergoing CAPD|Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day 14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.
11386127|NCT02243306|FG001|Participant Flow|Participants Undergoing APD|Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day 14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.
11386128|NCT02243306|OG000|Outcome|Participants Undergoing CAPD|Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.
11386129|NCT02243306|OG001|Outcome|Participants Undergoing APD|Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.
11386130|NCT02243306|OG000|Outcome|All Participants|Participants received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days.
11241359|NCT02486406|EG003|Reported Event|Mini Tablet, 9-11 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
11386131|NCT02243306|EG000|Reported Event|Participants Undergoing CAPD|Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.
11386132|NCT02243306|EG001|Reported Event|Participants Undergoing APD|Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.
11386133|NCT02246621|BG000|Baseline|Abemaciclib + NSAI|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386134|NCT02246621|BG001|Baseline|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386135|NCT02246621|BG002|Baseline|Total|Total of all reporting groups
11386136|NCT02246621|FG000|Participant Flow|Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors)|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386137|NCT02246621|FG001|Participant Flow|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386138|NCT02246621|OG000|Outcome|Abemaciclib + NSAI|150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386139|NCT02246621|OG001|Outcome|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386140|NCT02246621|EG000|Reported Event|Abemaciclib + NSAI|150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386141|NCT02246621|EG001|Reported Event|Placebo + NSAI|Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
11386142|NCT04093843|BG000|Baseline|Open Label|"Open label single arm study to determine safety and effectiveness of TMS for post stroke depression~TMS: NeuroStar TMS Therapy"
11386143|NCT04093843|FG000|Participant Flow|TMS: NeuroStar TMS Therapy|"Open label single arm study to determine safety and effectiveness of TMS for post stroke depression~TMS: NeuroStar TMS Therapy"
11386144|NCT04093843|OG000|Outcome|Open Label|"Open label single arm study to determine safety and effectiveness of TMS for post stroke depression~TMS: NeuroStar TMS Therapy"
11386145|NCT04093843|EG000|Reported Event|Open Label|"Open label single arm study to determine safety and effectiveness of TMS for post stroke depression~TMS: NeuroStar TMS Therapy"
11386146|NCT03926611|BG000|Baseline|LOU064 Arm 1|10 mg LOU064 qd capsule once daily
11386147|NCT03926611|BG001|Baseline|LOU064 Arm 2|35 mg capsule qd LOU064 once daily
11386148|NCT03926611|BG002|Baseline|LOU064 Arm 3|100 mg capsule qd LOU064 once daily
11386149|NCT03926611|BG003|Baseline|LOU064 Arm 4|10 mg capsule LOU064 bid
11386150|NCT03926611|BG004|Baseline|LOU064 Arm 5|25 mg capsule LOU064 bid
11386151|NCT03926611|BG005|Baseline|LOU064 Arm 6|100 mg capsule LOU064 bid
11386152|NCT03926611|BG006|Baseline|Placebo Arm|Participants took matching placebo twice daily
11386153|NCT03926611|BG007|Baseline|Total|Total of all reporting groups
11386154|NCT03926611|FG000|Participant Flow|LOU064 Arm 1|10 mg LOU064 qd capsule once daily
11386155|NCT03926611|FG001|Participant Flow|LOU064 Arm 2|35 mg capsule qd LOU064 once daily
11386156|NCT03926611|FG002|Participant Flow|LOU064 Arm 3|100 mg capsule qd LOU064 once daily
11386157|NCT03926611|FG003|Participant Flow|LOU064 Arm 4|10 mg capsule LOU064 bid
11386158|NCT03926611|FG004|Participant Flow|LOU064 Arm 5|25 mg capsule LOU064 bid
11386159|NCT03926611|FG005|Participant Flow|LOU064 Arm 6|100 mg capsule LOU064 bid
11386160|NCT03926611|FG006|Participant Flow|Placebo Arm|Took matching placebo twice daily
11386161|NCT03926611|OG000|Outcome|LOU064 Arm 1|10 mg LOU064 q.d. capsule once daily
11386162|NCT03926611|OG001|Outcome|LOU064 Arm 2|35 mg capsule q.d. LOU064 once daily
11386163|NCT03926611|OG002|Outcome|LOU064 Arm 3|100 mg capsule q.d. LOU064 once daily
11386164|NCT03926611|OG003|Outcome|LOU064 Arm 4|10 mg capsule LOU064 bid
11386165|NCT03926611|OG004|Outcome|LOU064 Arm 5|25 mg capsule LOU064 bid
11386166|NCT03926611|OG005|Outcome|LOU064 Arm 6|100 mg capsule LOU064 bid
11386167|NCT03926611|OG006|Outcome|Placebo Arm|Participants took matching placebo twice daily
11386168|NCT03926611|OG002|Outcome|LOU064 Arm 3|100 mg capsule qd LOU064 once daily
11386169|NCT03926611|OG000|Outcome|LOU064 Arm 1|10 mg LOU064 qd capsule once daily
11386170|NCT03926611|OG001|Outcome|LOU064 Arm 2|35 mg capsule qd LOU064 once daily
11386171|NCT03926611|EG000|Reported Event|LOU064 10mg q.d.|10 mg LOU064 qd capsule once daily
11386172|NCT03926611|EG001|Reported Event|LOU064 35mg q.d.|35 mg capsule qd LOU064 once daily
11386173|NCT03926611|EG002|Reported Event|LOU064 100mg q.d.|100 mg capsule qd LOU064 once daily
11386174|NCT03926611|EG003|Reported Event|LOU064 10mg b.i.d.|10 mg capsule LOU064 bid
11386175|NCT03926611|EG004|Reported Event|LOU064 25mg b.i.d.|25 mg capsule LOU064 bid
11386176|NCT03926611|EG005|Reported Event|LOU064 100mg b.i.d.|100 mg capsule LOU064 bid
11386177|NCT03926611|EG006|Reported Event|Any LOU064|Any LOU064
11386178|NCT03926611|EG007|Reported Event|Placebo|Participants took matching placebo twice daily
11386179|NCT03838484|BG000|Baseline|Healthy: Placebo First, Nicotine Last|Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386180|NCT03838484|BG001|Baseline|Healthy: Nicotine First, Placebo Last|Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386181|NCT03838484|BG002|Baseline|SCZ: Placebo First, Nicotine Last|Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386182|NCT03838484|BG003|Baseline|SCZ: Nicotine First, Placebo Last|Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386183|NCT03838484|BG004|Baseline|Total|Total of all reporting groups
11386184|NCT03838484|FG000|Participant Flow|Healthy: Placebo First, Nicotine Last|Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386185|NCT03838484|FG001|Participant Flow|Healthy: Nicotine First, Placebo Last|Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386186|NCT03838484|FG002|Participant Flow|SCZ: Placebo First, Nicotine Last|Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386187|NCT03838484|FG003|Participant Flow|SCZ: Nicotine First, Placebo Last|Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386188|NCT03838484|OG000|Outcome|Healthy: Placebo|Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
11386189|NCT03838484|OG001|Outcome|Healthy: Nicotine|Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
11386190|NCT03838484|OG002|Outcome|SCZ: Placebo|Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
11386191|NCT03838484|OG003|Outcome|SCZ: Nicotine|Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
11386192|NCT03838484|OG000|Outcome|Healthy: Nicotine|Healthy controls will apply nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386193|NCT03838484|OG001|Outcome|Healthy: Placebo|Healthy controls will apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386194|NCT03838484|OG002|Outcome|SCZ: Nicotine|Subjects with schizophrenia (SCZ) will apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386195|NCT03838484|OG003|Outcome|SCZ: Placebo|Subjects with schizophrenia (SCZ) will apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386196|NCT03838484|OG000|Outcome|Healthy: Nicotine|Healthy controls will apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386197|NCT03838484|OG003|Outcome|SCZ: Placebo|Subjects with schizophrenia (SCZ) will apply placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
11386198|NCT03838484|EG000|Reported Event|Healthy: Placebo|Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task.
11386199|NCT03838484|EG001|Reported Event|Healthy: Nicotine|Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.
11386200|NCT03838484|EG002|Reported Event|SCZ: Placebo|Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task.
11386201|NCT03838484|EG003|Reported Event|SCZ: Nicotine|Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.
11386202|NCT03814720|BG000|Baseline|Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years|"H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11197058|NCT02169219|OG000|Outcome|Glucocorticoids and Rituximab|"This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.~Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.~Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2"
11386203|NCT03814720|BG001|Baseline|Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386204|NCT03814720|BG002|Baseline|Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386205|NCT03814720|BG003|Baseline|Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386206|NCT03814720|BG004|Baseline|Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386207|NCT03814720|BG005|Baseline|Total|Total of all reporting groups
11386208|NCT03814720|FG000|Participant Flow|Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years|"H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386209|NCT03814720|FG001|Participant Flow|Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386210|NCT03814720|FG002|Participant Flow|Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386211|NCT03814720|FG003|Participant Flow|Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11197059|NCT02169219|OG000|Outcome|Glucocorticoids and Rituximab|Measure Description: Disease damage was assessed by the Vasculitis Damage Index (VDI) at baseline and end of study
11386212|NCT03814720|FG004|Participant Flow|Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386213|NCT03814720|OG000|Outcome|Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years|"H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386214|NCT03814720|OG001|Outcome|Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386215|NCT03814720|OG002|Outcome|Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386216|NCT03814720|OG003|Outcome|Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386217|NCT03814720|OG004|Outcome|Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years|"H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)~VRC-FLUNPF099-00-VP (H1ssF_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes."
11386218|NCT03814720|OG005|Outcome|Overall Incidence H1ssF_3928 (20 mcg and 60 mcg)|H1ssF_3928 dose groups included adults who received at least one dose of H1ssF_3928.
11386219|NCT03814720|EG000|Reported Event|Overall Incidence H1ssF_3928 (20 mcg), Ages 18-40 Years|"H1ssF_3928 (20 mcg) dose group included adults (ages 18-40 years) who received a single 20 mcg dose of H1ssF_3928.~Population included all enrolled subjects who received a H1ssF_3928 (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5)."
11386220|NCT03814720|EG001|Reported Event|Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years|"H1ssF_3928 (60 mcg) dose groups included adults (ages 18-40 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.~Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12)."
11386221|NCT03814720|EG002|Reported Event|Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years|"H1ssF_3928 (60 mcg) dose groups included adults (ages 41-49 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.~Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12)."
11386222|NCT03814720|EG003|Reported Event|Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years|"H1ssF_3928 (60 mcg) dose groups included adults (ages 50-59 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.~Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=12)."
11386223|NCT03814720|EG004|Reported Event|Group 2D: H1ssF_3928 (60 mcg), Ages 60-70|"H1ssF_3928 (60 mcg) dose groups included adults (ages 60-70 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.~Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=11)."
11386224|NCT03814720|EG005|Reported Event|Overall Incidence H1ssF_3928 (60 mcg)|"H1ssF_3928 (60 mcg) dose groups included adults stratified by age (ages 18-40 years, ages 41-49 years, ages 50-59 years, and ages 60-70 years) who were randomized to receive two doses of 60 mcg H1ssF_3928 16 weeks apart.~Population included all enrolled subjects who received at least one H1ssF_3928 (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47)."
11386225|NCT03635424|BG000|Baseline|Medtronic TAVR Systems|Treatment with Medtronic Evolut PRO and Evolut R systems
11386226|NCT03635424|FG000|Participant Flow|Medtronic TAVR Systems|Treatment with Medtronic Evolut PRO and Evolut R systems
11386227|NCT03635424|OG000|Outcome|Medtronic TAVR Systems|Treatment with Medtronic Evolut PRO and Evolut R systems
11386228|NCT03635424|EG000|Reported Event|Medtronic TAVR Systems|Treatment with Medtronic Evolut PRO and Evolut R systems
11386229|NCT03529110|BG000|Baseline|Trastuzumab Deruxtecan (T-DXd)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
11386230|NCT03529110|BG001|Baseline|Ado-trastuzumab Emtansine (T-DM1)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
11386231|NCT03529110|BG002|Baseline|Total|Total of all reporting groups
11386232|NCT03529110|FG000|Participant Flow|Trastuzumab Deruxtecan (T-DXd)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
11386233|NCT03529110|FG001|Participant Flow|Ado-trastuzumab Emtansine (T-DM1)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
11386234|NCT03529110|OG000|Outcome|Trastuzumab Deruxtecan (T-DXd)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
11386235|NCT03529110|OG001|Outcome|Ado-trastuzumab Emtansine (T-DM1)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
11386236|NCT03529110|EG000|Reported Event|Trastuzumab Deruxtecan (T-DXd)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
11386237|NCT03529110|EG001|Reported Event|Ado-trastuzumab Emtansine (T-DM1)|Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
11386238|NCT03517540|BG000|Baseline|Arm A: Tropifexor (LJN452) - Dose 1|tropifexor 140 mg, once daily
11386239|NCT03517540|BG001|Baseline|Arm B: Cenicriviroc (CVC)|CVC 150 mg, once daily
11197060|NCT02169219|EG000|Reported Event|Glucocorticoids and Rituximab|"Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.~Prednisone will be tapered over 8 weeks as follows:~60mg for 2 weeks~40mg for 2 weeks~30mg for 1 week~20mg for 1 week~10mg for 1 week~5mg for 1 week~Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2"
11197061|NCT02169271|BG000|Baseline|Aspirin|1 tablet of aspirin 100 mg a day for one year
11197062|NCT02169271|BG001|Baseline|Placebo|1 tablet of placebo a day for one year
11197063|NCT02169271|BG002|Baseline|Total|Total of all reporting groups
11197064|NCT02169271|FG000|Participant Flow|Aspirin|1 tablet of aspirin 100 mg a day for one year
11197065|NCT02169271|FG001|Participant Flow|Placebo|1 tablet of placebo a day for one year
11386240|NCT03517540|BG002|Baseline|Arm C: Tropifexor (LJN452) Dose 1 + CVC|tropifexor 140 mg + CVC 150 mg, once daily
11386241|NCT03517540|BG003|Baseline|Arm D: Tropifexor Dose 2 + CVC|tropifexor 90 mg + CVC 150 mg, once daily
11386242|NCT03517540|BG004|Baseline|Total|Total of all reporting groups
11386243|NCT03517540|FG000|Participant Flow|Arm A: Tropifexor (LJN452) - Dose 1|tropifexor 140 mg, once daily
11386244|NCT03517540|FG001|Participant Flow|Arm B: Cenicriviroc (CVC)|CVC 150 mg, once daily
11386245|NCT03517540|FG002|Participant Flow|Arm C: Tropifexor (LJN452) Dose 1 + CVC|tropifexor 140 mg + CVC 150 mg, once daily
11386246|NCT03517540|FG003|Participant Flow|Arm D: Tropifexor Dose 2 + CVC|tropifexor 90 mg + CVC 150 mg, once daily
11197066|NCT02169271|OG000|Outcome|Aspirin|1 tablet of aspirin 100 mg a day for one year
11197067|NCT02169271|OG001|Outcome|Placebo|1 tablet of placebo a day for one year
11197068|NCT02169271|EG000|Reported Event|Aspirin|1 tablet of aspirin 100 mg a day for one year
11197069|NCT02169271|EG001|Reported Event|Placebo|1 tablet of placebo a day for one year
11197070|NCT02169284|BG000|Baseline|Group I (Erlotinib Hydrochloride)|Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197071|NCT02169284|BG001|Baseline|Group II (Placebo)|Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197072|NCT02169284|BG002|Baseline|Total|Total of all reporting groups
11197073|NCT02169284|FG000|Participant Flow|Group I (Erlotinib Hydrochloride)|Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11386247|NCT03517540|OG000|Outcome|Arm A: Tropifexor (LJN452) - Dose 1|tropifexor 140 mg, once daily
11386248|NCT03517540|OG001|Outcome|Arm B: Cenicriviroc (CVC)|CVC 150 mg, once daily
11386249|NCT03517540|OG002|Outcome|Arm C: Tropifexor (LJN452) Dose 1 + CVC|tropifexor 140 mg + CVC 150 mg, once daily
11386250|NCT03517540|OG003|Outcome|Arm D: Tropifexor Dose 2 + CVC|tropifexor 90 mg + CVC 150 mg, once daily
11386251|NCT03517540|EG000|Reported Event|Tropifexor 140mg|Tropifexor 140mg
11386252|NCT03517540|EG001|Reported Event|CVC 150mg|CVC 150mg
11386253|NCT03517540|EG002|Reported Event|Tropifexor 140mcg + CVC 150mg|Tropifexor 140mg + CVC 150mg
11197074|NCT02169284|FG001|Participant Flow|Group II (Placebo)|Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197075|NCT02169284|OG000|Outcome|Group I (Erlotinib Hydrochloride)|Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197076|NCT02169284|OG001|Outcome|Group II (Placebo)|Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197077|NCT02169284|OG000|Outcome|Group I (Erlotinib Hydrochloride)|"Patients receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo TURBT or cystectomy"
11386254|NCT03517540|EG003|Reported Event|Tropifexor 90 mg + CVC 150 mg|Tropifexor 90 mg + CVC 150 mg
11386255|NCT03443635|BG000|Baseline|Treatment|"Subjects receiving hands-on cooking and nutrition education classes~Treatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use."
11386256|NCT03443635|BG001|Baseline|Control|Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
11386257|NCT03443635|BG002|Baseline|Total|Total of all reporting groups
11386258|NCT03443635|FG000|Participant Flow|Treatment|"Subjects receiving hands-on cooking and nutrition education classes~Treatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use."
11386259|NCT03443635|FG001|Participant Flow|Control|Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
11386260|NCT03443635|OG000|Outcome|Treatment|"Subjects receiving hands-on cooking and nutrition education classes~Treatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use."
11386261|NCT03443635|OG001|Outcome|Control|Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees/providers) or medical care (for patients)
11386262|NCT03443635|EG000|Reported Event|Treatment|"Subjects receiving hands-on cooking and nutrition education classes~Treatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use."
11386263|NCT03443635|EG001|Reported Event|Control|Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees/providers) or medical care (for patients)
11386264|NCT03437278|BG000|Baseline|Ligelizumab 24 mg|Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386265|NCT03437278|BG001|Baseline|Ligelizumab 120 mg|Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386266|NCT03437278|BG002|Baseline|Placebo + Ligelizumab 120 mg|Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
11386267|NCT03437278|BG003|Baseline|Total|Total of all reporting groups
11386268|NCT03437278|FG000|Participant Flow|Ligelizumab 24 mg|Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386269|NCT03437278|FG001|Participant Flow|Ligelizumab 120 mg|Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386270|NCT03437278|FG002|Participant Flow|Placebo + Ligelizumab 120 mg|Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
11386271|NCT03437278|OG000|Outcome|Ligelizumab 24 mg|Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11197078|NCT02169284|OG001|Outcome|Group II (Placebo)|"Patients receive placebo PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies~Therapeutic Conventional Surgery: Undergo TURBT or cystectomy"
11197079|NCT02169284|EG000|Reported Event|Group I (Erlotinib Hydrochloride)|Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11386272|NCT03437278|OG001|Outcome|Ligelizumab 120 mg|Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386273|NCT03437278|OG002|Outcome|Placebo + Ligelizumab 120 mg|Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
11386274|NCT03437278|OG000|Outcome|All Participants With PK Data|Participants in the study (low dose, high dose and placebo+high dose) with available pharmacokinetic data
11386275|NCT03437278|EG000|Reported Event|Ligelizumab 24 mg|Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386276|NCT03437278|EG001|Reported Event|Ligelizumab 120 mg|Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
11386277|NCT03437278|EG002|Reported Event|Placebo + Ligelizumab 120 mg|Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
11386278|NCT03437278|EG003|Reported Event|Total|Total
11386279|NCT03350815|BG000|Baseline|Secukinumab 150 mg - 150 mg|AIN457 150 mg - 150 mg
11386280|NCT03350815|FG000|Participant Flow|Period 1: Secukinumab 150 mg|Participants received Secukinumab 150 mg in Period 1
11386281|NCT03350815|FG001|Participant Flow|Period 2: Secukinumab 300 mg (Period 1 Inadequate Responders)|Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and randomized to receive Secukinumab 300 mg in Period 2
11386282|NCT03350815|FG002|Participant Flow|Secukinumab 150 mg (Period 1 Inadequate Responders)|Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and continued with Secukinumab 150 mg in Period 2
11386283|NCT03350815|FG003|Participant Flow|Secukinumab 150 mg (Period 1 Responders)|Participants received Secukinumab 150 mg in Period 1 were assessed as responders and continued with Secukinumab 150 mg in Period 2
11386284|NCT03350815|OG000|Outcome|Secukinumab 150 mg - 300 mg (IR)|AIN457 150 mg - 300 mg
11386285|NCT03350815|OG001|Outcome|Secukinumab 150 mg - 150 mg (IR)|AIN457 150 mg - 150 mg (IR)
11386286|NCT03350815|OG000|Outcome|Secukinumab 150 mg - 300 mg (IR)|"AIN457 150 mg - 300 mg~This Arm represents inadequate responders who received 150 mg of the intervention in Period 1 and 2"
11386287|NCT03350815|OG001|Outcome|Secukinumab 150 mg - 150 mg (IR)|AIN457 150 mg - 150 mg
11386288|NCT03350815|OG001|Outcome|Secukinumab 150 mg - 150 mg|AIN457 150 mg - 150 mg
11386289|NCT03350815|EG000|Reported Event|Treatment Period 2 Secukinumab 150 mg - 150 mg (R)|Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
11386290|NCT03350815|EG001|Reported Event|Treatment Period 1 Secukinumab 150 mg|Treatment Period 1 Secukinumab 150 mg
11386291|NCT03350815|EG002|Reported Event|Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)|Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
11386292|NCT03350815|EG003|Reported Event|Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)|Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
11197080|NCT02169284|EG001|Reported Event|Group II (Placebo)|Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
11197081|NCT02169336|BG000|Baseline|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197082|NCT02169336|BG001|Baseline|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
10800088|NCT02673398|EG000|Reported Event|Treatment (Neratinib)|"Patients receive neratinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Comprehensive Geriatric Assessment: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies~Neratinib: Given PO~Pharmacological Study: Correlative studies"
11197083|NCT02169336|BG002|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
11197084|NCT02169336|BG003|Baseline|Total|Total of all reporting groups
11197085|NCT02169336|FG000|Participant Flow|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197086|NCT02169336|FG001|Participant Flow|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197087|NCT02169336|FG002|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
11197088|NCT02169336|OG000|Outcome|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197089|NCT02169336|OG001|Outcome|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197090|NCT02169336|OG002|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
11197091|NCT02169336|EG000|Reported Event|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197092|NCT02169336|EG001|Reported Event|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
11197093|NCT02169336|EG002|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
11197094|NCT02169414|BG000|Baseline|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197095|NCT02169414|BG001|Baseline|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11386293|NCT03249714|BG000|Baseline|OMB 20 mg|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
11386294|NCT03249714|BG001|Baseline|Placebo|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
11386295|NCT03249714|BG002|Baseline|Total|Total of all reporting groups
11386296|NCT03249714|FG000|Participant Flow|OMB 20 mg|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
11386297|NCT03249714|FG001|Participant Flow|Placebo - OMB 20 mg|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
11386298|NCT03249714|OG000|Outcome|OMB 20 mg|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
11386299|NCT03249714|OG001|Outcome|Placebo|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
11386300|NCT03249714|OG000|Outcome|OMB 20 mg Japan|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients
11386301|NCT03249714|OG001|Outcome|Placebo Japan|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - Japanese patients
11386302|NCT03249714|OG002|Outcome|OMB 20 mg Non-Japan|"CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter~- non-Japanese patients"
11386303|NCT03249714|OG003|Outcome|Placebo Non-Japan|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
11386304|NCT03249714|OG000|Outcome|OMB 20 mg|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
11386305|NCT03249714|OG001|Outcome|Placebo|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
11386306|NCT03249714|OG000|Outcome|OMB 20 mg|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
11386307|NCT03249714|OG001|Outcome|OMB 20 mg Non-Japan|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non - Japanese patients
11386308|NCT03249714|OG002|Outcome|OMB 20 mg - All Patients|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
11386309|NCT03249714|OG002|Outcome|OMB 20 mg Non-Japan|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter- non-Japanese participants
11386310|NCT03249714|OG001|Outcome|Placebo (Core) - OMB 20 mg (Extension)|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
11386311|NCT03249714|OG000|Outcome|OMB 20 mg Japan|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks - Japanese patients
11386312|NCT03249714|OG001|Outcome|OMB 20 mg Non-Japan|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks - non-Japanese patients
11386313|NCT03249714|OG001|Outcome|Placebo (Core) - OMB 20mg (Extension)|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
11386314|NCT03249714|EG000|Reported Event|OMB 20mg Core|CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
10803573|NCT03417102|BG001|Baseline|Fitusiran 80 mg Prophylaxis|Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months.
10803574|NCT03417102|BG002|Baseline|Total Title|
11386315|NCT03249714|EG001|Reported Event|Placebo Core|CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
11386316|NCT03249714|EG002|Reported Event|OMB 20mg Continued|EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
11386317|NCT03249714|EG003|Reported Event|OMB 20mg Switched (From Placebo)|EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
11386318|NCT03170882|BG000|Baseline|Pomalidomide 4 mg + Dexamethasone 40 mg|Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386319|NCT03170882|BG001|Baseline|Ixazomib 4 mg + Dexamethasone 20 mg|Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386320|NCT03170882|BG002|Baseline|Total|Total of all reporting groups
11386321|NCT03170882|FG000|Participant Flow|Pomalidomide 4 mg + Dexamethasone 40 mg|Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386322|NCT03170882|FG001|Participant Flow|Ixazomib 4 mg + Dexamethasone 20 mg|Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386323|NCT03170882|OG000|Outcome|Pomalidomide 4 mg + Dexamethasone 40 mg|Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386324|NCT03170882|OG001|Outcome|Ixazomib 4 mg + Dexamethasone 20 mg|Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386325|NCT03170882|EG000|Reported Event|Pomalidomide 4 mg + Dexamethasone 40 mg|Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386326|NCT03170882|EG001|Reported Event|Ixazomib 4 mg + Dexamethasone 20 mg|Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
11386327|NCT03074318|BG000|Baseline|Phase 1 (1.5 mg/m^2 Trabectedin)|"Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386328|NCT03074318|BG001|Baseline|Phase 1 (1.0 mg/m^2 Trabectedin)|"Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386329|NCT03074318|BG002|Baseline|Phase 1 (1.2 mg/m^2 Trabectedin)|"Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386330|NCT03074318|BG003|Baseline|Phase 2 (Avelumab, Trabectedin)|"Phase 2: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386331|NCT03074318|BG004|Baseline|Total|Total of all reporting groups
11386332|NCT03074318|FG000|Participant Flow|Phase 1 Dose Level 1|Subjects received 1.5 mg/m^2 of trabectedin plus avelumab.
11386333|NCT03074318|FG001|Participant Flow|Phase 1 Dose Level 2|Subjects received 1.0 mg/m^2 of trabectedin plus avelumab
11386334|NCT03074318|FG002|Participant Flow|Phase 1 Dose Level 3|Subjects received 1.2 mg/m^2 of trabectedin plus avelumab.
11386335|NCT03074318|FG003|Participant Flow|Phase 2|Subjects received 1.0 mg/m^2 trabectedin plus avelumab.
11386336|NCT03074318|OG000|Outcome|Phase 1 - 1.5 mg/m^2 Trabectedin|Subjects received 1.5 mg/m2 of trabectedin plus avelumab.
11386337|NCT03074318|OG001|Outcome|Phase 1 - 1.0 mg/m^2 Trabectedin|Subjects received 1.0 mg/m^2 trabectedin plus avelumab.
11386338|NCT03074318|OG002|Outcome|Phase 1 - 1.2 mg/m^2 Trabectedin|Subjects received 1.2 mg/m^2 trabectedin plus avelumab.
11386339|NCT03074318|OG003|Outcome|Phase 2 - 1.0 mg/m^2 Trabectedin|Subjects received 1.0 mg/m^2 trabectedin plus avelumab.
11386340|NCT03074318|OG000|Outcome|Treatment (Avelumab, Trabectedin)|Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 dose.
11197096|NCT02169414|BG002|Baseline|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11386341|NCT03074318|OG000|Outcome|Phase 1 - 1.5 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11338216|NCT03604341|FG000|Participant Flow|Gestational Age up to 10w0d - Dronabinol|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain"
11338217|NCT03604341|FG001|Participant Flow|Gestational Age up to 10w0d - Placebo|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain"
11338218|NCT03604341|OG000|Outcome|Gestational Age up to 10w0d - Dronabinol|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain"
11338219|NCT03604341|OG001|Outcome|Gestational Age up to 10w0d - Placebo|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain"
11338220|NCT03604341|EG000|Reported Event|Gestational Age up to 10w0d - Dronabinol|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain"
11338221|NCT03604341|EG001|Reported Event|Gestational Age up to 10w0d - Placebo|"Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo~Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain"
11338222|NCT03604497|BG000|Baseline|All Study Participants|"baseline - participants do not receive any alerts on their mobile smartphone when near intersections~active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections (beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection)~retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior (no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage)"
11338223|NCT03604497|FG000|Participant Flow|All Study Participants|"baseline - participants do not receive any alerts on their mobile smartphone when near intersections~active intervention phase - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections (beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection)~retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior (no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage)~All participants engaged in all three phrases in the same order"
11338224|NCT03604497|OG000|Outcome|Beacon Alerts|"active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections~beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection"
11338225|NCT03604497|OG001|Outcome|no Alerts Baseline|baseline - participants do not receive any alerts on their mobile smartphone when near intersections
11338226|NCT03604497|OG002|Outcome|no Alerts Retention|"retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior~no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage"
11338227|NCT03604497|EG000|Reported Event|Beacon Alerts|"active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections~beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection"
11338228|NCT03604497|EG001|Reported Event|no Alerts Baseline|baseline - participants do not receive any alerts on their mobile smartphone when near intersections
11338229|NCT03604497|EG002|Reported Event|no Alerts Retention|"retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior~no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage"
11338230|NCT03604523|BG000|Baseline|Dilation by Balloon|"Esophageal dilation by balloon device.~Dilation by Balloon: Esophageal dilation by balloon device."
11338231|NCT03604523|BG001|Baseline|Dilation by Semi-rigid Savary|"Esophageal dilation by semi-rigid savary device.~Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device"
11338232|NCT03604523|BG002|Baseline|Total|Total of all reporting groups
11338233|NCT03604523|FG000|Participant Flow|Dilation by Balloon|"Esophageal dilation by balloon device.~Dilation by Balloon: Esophageal dilation by balloon device."
11338234|NCT03604523|FG001|Participant Flow|Dilation by Semi-rigid Savary|"Esophageal dilation by semi-rigid savary device.~Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device"
11338235|NCT03604523|OG000|Outcome|Dilation by Balloon|"Esophageal dilation by balloon device.~Dilation by Balloon: Esophageal dilation by balloon device."
11338236|NCT03604523|OG001|Outcome|Dilation by Semi-rigid Savary|"Esophageal dilation by semi-rigid savary device.~Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device"
11338237|NCT03604523|EG000|Reported Event|Dilation by Balloon|"Esophageal dilation by balloon device.~Dilation by Balloon: Esophageal dilation by balloon device."
11338238|NCT03604523|EG001|Reported Event|Dilation by Semi-rigid Savary|"Esophageal dilation by semi-rigid savary device.~Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device"
11338239|NCT03604705|BG000|Baseline|Treatment Period - MITT|Evaluation of APX001 for the first-line treatment for candidemia, including suspected or confirmed antifungal-resistant candidemia, in non-neutropenic patients ≥ 18 years of age who had at least 1 positive blood culture within the 96 hours prior to starting study drug. Modified Intent-to-Treat (MITT) Population. The MITT Population contained 20 (95.2%) patients.
11338240|NCT03604705|FG000|Participant Flow|APX001 Treatment|APX001: APX001 IV administration followed by APX001 oral tablet administration
11338241|NCT03604705|OG000|Outcome|Treatment Period - MITT|Treatment Success was defined as meeting all of the following criteria: 1) 2 consecutive blood cultures were negative for Candida spp.; 2) Alive at EOST; and 3) No concomitant use of any other systemic antifungal therapies through EOST. Treatment Failure is defined as any case that does not meet the criteria for Treatment Success.
11338242|NCT03604705|OG000|Outcome|MITT Population|MITT = Modified Intent-to-Treat population
11386342|NCT03074318|OG001|Outcome|Phase 1 - 1.0 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11197097|NCT02169414|BG003|Baseline|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11386343|NCT03074318|OG002|Outcome|Phase 1 - 1.2 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386344|NCT03074318|OG003|Outcome|Phase 2 - 1.0 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386345|NCT03074318|OG000|Outcome|Phase 1, 1.5 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386346|NCT03074318|OG001|Outcome|Phase 1, 1.0 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386347|NCT03074318|OG002|Outcome|Phase 1, 1.2 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386348|NCT03074318|OG003|Outcome|Phase 2, 1.0 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11197098|NCT02169414|BG004|Baseline|Total|Total of all reporting groups
11197099|NCT02169414|FG000|Participant Flow|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197100|NCT02169414|FG001|Participant Flow|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197101|NCT02169414|FG002|Participant Flow|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11338243|NCT03604705|OG000|Outcome|EOST (End of Study Drug Treatment)|Eradication
11338244|NCT03604705|OG001|Outcome|EOT (End of Antifungal Treatment)|Eradication
11338245|NCT03604705|OG002|Outcome|Follow-up 2 Weeks After EOT|Recurrence
11338246|NCT03604705|OG003|Outcome|Follow-up 4 Weeks After EOT|Recurrence
11338247|NCT03604705|OG000|Outcome|Treatment Success 2 Weeks After EOT|Treatment Success determined by the DRC by visit for the MITT Population.
11338248|NCT03604705|OG001|Outcome|Treatment Success 4 Weeks After EOT|Treatment success determined by the DRC by visit for the MITT Population.
11338249|NCT03604705|OG000|Outcome|Safety Population|Twenty-one patients were dosed with APX001 and composed the ITT/Safety Population.
11338250|NCT03604705|EG000|Reported Event|Safety Population|Twenty-one patients were dosed with APX001 and composed the ITT/Safety Population.
11338251|NCT03605212|BG000|Baseline|Cohort 1|"Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338252|NCT03605212|BG001|Baseline|Cohort 2|"Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338253|NCT03605212|BG002|Baseline|Cohort 3|"Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338254|NCT03605212|BG003|Baseline|Cohort 4|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338255|NCT03605212|BG004|Baseline|Adults|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338256|NCT03605212|BG005|Baseline|Total|Total of all reporting groups
11338257|NCT03605212|FG000|Participant Flow|Cohort 1|"Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338258|NCT03605212|FG001|Participant Flow|Cohort 2|"Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338259|NCT03605212|FG002|Participant Flow|Cohort 3|"Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338260|NCT03605212|FG003|Participant Flow|Cohort 4|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338261|NCT03605212|FG004|Participant Flow|Adults|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338262|NCT03605212|OG000|Outcome|Cohort 1|"Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338263|NCT03605212|OG001|Outcome|Cohort 2|"Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338264|NCT03605212|OG002|Outcome|Cohort 3|"Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338265|NCT03605212|OG003|Outcome|Cohort 4|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338266|NCT03605212|OG004|Outcome|Adults|"Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338267|NCT03605212|OG004|Outcome|Adults|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338268|NCT03605212|EG000|Reported Event|Cohort 1|"Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338269|NCT03605212|EG001|Reported Event|Cohort 2|"Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days~Febuxostat: Intervention is orally administered to patients in this arm."
11338270|NCT03605212|EG002|Reported Event|Cohort 3|"Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338271|NCT03605212|EG003|Reported Event|Cohort 4|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338272|NCT03605212|EG004|Reported Event|Adults|"Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)~Febuxostat: Intervention is orally administered to patients in this arm."
11338273|NCT03605693|BG000|Baseline|Early Psychological Intervention|"Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner.~Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner."
11338274|NCT03605693|BG001|Baseline|Usual Care|Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
11338275|NCT03605693|BG002|Baseline|Total|Total of all reporting groups
11338276|NCT03605693|FG000|Participant Flow|Early Psychological Intervention|"Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner.~Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner."
11338277|NCT03605693|FG001|Participant Flow|Usual Care|Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
11338278|NCT03605693|OG000|Outcome|Early Psychological Intervention|"Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner.~Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner."
11338279|NCT03605693|OG001|Outcome|Usual Care|Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
11386349|NCT03074318|EG000|Reported Event|Phase 1 - 1.5 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386350|NCT03074318|EG001|Reported Event|Phase 1 - 1.0 mg/m^2 Trabectedin|Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.
11386351|NCT03074318|EG002|Reported Event|Phase 1 - 1.2mg/m^2 Trabectedin|Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.
11386352|NCT03074318|EG003|Reported Event|Phase 2 - 1.0 mg/m^2 Trabectedin|"Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.~Avelumab: Given IV~Trabectedin: Given IV"
11386353|NCT03010319|BG000|Baseline|PriMatrix|"Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.~PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386354|NCT03010319|BG001|Baseline|Standard of Care|"Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386355|NCT03010319|BG002|Baseline|Total|Total of all reporting groups
11386356|NCT03010319|FG000|Participant Flow|PriMatrix|"Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.~PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386357|NCT03010319|FG001|Participant Flow|Standard of Care|"Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386358|NCT03010319|OG000|Outcome|PriMatrix|"Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.~PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386359|NCT03010319|OG001|Outcome|Standard of Care|"Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386360|NCT03010319|EG000|Reported Event|PriMatrix|"Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.~PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11386361|NCT03010319|EG001|Reported Event|Standard of Care|"Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.~Secondary Dressings: Dressings to ensure moist wound environment~Offloading device: Offloading device to decrease pressure to wound area"
11197102|NCT02169414|FG003|Participant Flow|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197103|NCT02169414|OG000|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
11386362|NCT02915016|BG000|Baseline|Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386363|NCT02915016|BG001|Baseline|Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386364|NCT02915016|BG002|Baseline|Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386365|NCT02915016|BG003|Baseline|Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386366|NCT02915016|BG004|Baseline|Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386367|NCT02915016|BG005|Baseline|Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386368|NCT02915016|BG006|Baseline|Group 7: Placebo + Protein/AS01B|Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386369|NCT02915016|BG007|Baseline|Group 8: Placebo|Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386370|NCT02915016|BG008|Baseline|Total|Total of all reporting groups
11386371|NCT02915016|FG000|Participant Flow|Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386372|NCT02915016|FG001|Participant Flow|Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386373|NCT02915016|FG002|Participant Flow|Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386374|NCT02915016|FG003|Participant Flow|Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386375|NCT02915016|FG004|Participant Flow|Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386376|NCT02915016|FG005|Participant Flow|Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386377|NCT02915016|FG006|Participant Flow|Group 7: Placebo + Protein/AS01B|"Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11197104|NCT02169414|OG001|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
11386378|NCT02915016|FG007|Participant Flow|Group 8: Placebo|"Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386379|NCT02915016|OG000|Outcome|Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386380|NCT02915016|OG001|Outcome|Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386381|NCT02915016|OG002|Outcome|Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386382|NCT02915016|OG003|Outcome|Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386383|NCT02915016|OG004|Outcome|Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386384|NCT02915016|OG005|Outcome|Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B|"Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386385|NCT02915016|OG006|Outcome|Group 7: Placebo + Protein/AS01B|"Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.~Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11386386|NCT02915016|OG007|Outcome|Group 8: Placebo|"Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.~Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products."
11197105|NCT02169414|OG002|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
11197106|NCT02169414|OG003|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
11386387|NCT02915016|EG000|Reported Event|Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386388|NCT02915016|EG001|Reported Event|Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386389|NCT02915016|EG002|Reported Event|Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386390|NCT02915016|EG003|Reported Event|Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11197107|NCT02169414|OG000|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
11197108|NCT02169414|OG001|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
11197109|NCT02169414|OG002|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
11197110|NCT02169414|OG003|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
11197111|NCT02169414|EG000|Reported Event|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197112|NCT02169414|EG001|Reported Event|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
10800089|NCT02614261|BG000|Baseline|Placebo|"Double-blind treatment phase: Participants received placebo once a month by subcutaneous injection for 3 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
11386391|NCT02915016|EG004|Reported Event|Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386392|NCT02915016|EG005|Reported Event|Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B|Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386393|NCT02915016|EG006|Reported Event|Group 7: Placebo + Protein/AS01B|Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386394|NCT02915016|EG007|Reported Event|Group 8: Placebo|Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
11386395|NCT02871401|BG000|Baseline|Valganciclovir|"Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks~Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386396|NCT02871401|BG001|Baseline|Placebo|"Placebo, 2 pills by mouth one time per day x 12 weeks~Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386397|NCT02871401|BG002|Baseline|Total|Total of all reporting groups
11386398|NCT02871401|FG000|Participant Flow|Valganciclovir|"Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks~Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386399|NCT02871401|FG001|Participant Flow|Placebo|"Placebo, 2 pills by mouth one time per day x 12 weeks~Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386400|NCT02871401|OG000|Outcome|Valganciclovir|"Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks~Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386401|NCT02871401|OG001|Outcome|Placebo|"Placebo, 2 pills by mouth one time per day x 12 weeks~Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386402|NCT02871401|EG000|Reported Event|Valganciclovir|"Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks~Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386403|NCT02871401|EG001|Reported Event|Placebo|"Placebo, 2 pills by mouth one time per day x 12 weeks~Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks."
11386404|NCT02811913|BG000|Baseline|Stroke Cohort|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions~session 1 - High frequency rTMS targeting contralesional sensory cortex~session 2 - Low frequency rTMS~session 3 - sham rTMS~peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386405|NCT02811913|FG000|Participant Flow|Stroke Cohort|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions~session 1 - High frequency rTMS targeting contralesional sensory cortex~session 2 - Low frequency rTMS~session 3 - sham rTMS~peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386406|NCT02811913|OG000|Outcome|High Frequency rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386407|NCT02811913|OG001|Outcome|Low Frequency rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386408|NCT02811913|OG002|Outcome|Sham rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received sham Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386409|NCT02811913|OG002|Outcome|Sham rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received sham rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386410|NCT02811913|EG000|Reported Event|High Frequency rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386411|NCT02811913|EG001|Reported Event|Low Frequency rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386412|NCT02811913|EG002|Reported Event|Sham rTMS|"Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study~For these sessions, participants received sham rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS"
11386413|NCT02701283|BG000|Baseline|Randomized Controlled Trial - Medtronic TAVR Systems|Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial
11386414|NCT02701283|BG001|Baseline|Randomized Controlled Trial - SAVR|Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial
11386415|NCT02701283|BG002|Baseline|Continued Access Study - Medtronic TAVR Systems|Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
11386416|NCT02701283|BG003|Baseline|Total|Total of all reporting groups
11386417|NCT02701283|FG000|Participant Flow|Randomized Controlled Trial - Medtronic TAVR Systems|Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial
11386418|NCT02701283|FG001|Participant Flow|Randomized Controlled Trial - SAVR|Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial
11386419|NCT02701283|FG002|Participant Flow|Continued Access Study - Medtronic TAVR Systems|Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
11386420|NCT02701283|OG000|Outcome|Randomized Controlled Trial - Medtronic TAVR Systems|Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial
11386421|NCT02701283|OG001|Outcome|Randomized Controlled Trial - SAVR|Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial
11386422|NCT02701283|OG002|Outcome|Continued Access Study - Medtronic TAVR Systems|Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
11386423|NCT02701283|OG000|Outcome|Medtronic TAVR Systems|Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems
11386424|NCT02701283|OG001|Outcome|SAVR|Surgical Aortic Valve Replacement (SAVR)
11386425|NCT02701283|OG001|Outcome|Continued Access Study - Medtronic TAVR Systems|Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
11386426|NCT02701283|EG000|Reported Event|Randomized Controlled Trial - Medtronic TAVR Systems|Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial
11386427|NCT02701283|EG001|Reported Event|Randomized Controlled Trial - SAVR|Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial
11386428|NCT02701283|EG002|Reported Event|Continued Access Study - Medtronic TAVR Systems|Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
10803575|NCT03417102|FG000|Participant Flow|Bypassing Agents (BPA) On-demand|Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months.
10965818|NCT00884117|OG001|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11386429|NCT02696031|BG000|Baseline|Secukinumab, Load, Core Phase|AIN457 150 mg s.c. load, Core Phase
11386430|NCT02696031|BG001|Baseline|Secukinumab, No Load, Core Phase|AIN457 150 mg s.c. no load, Core Phase
11386431|NCT02696031|BG002|Baseline|Placebo, Core Phase|Placebo s.c., Core Phase
11386432|NCT02696031|BG003|Baseline|Total|Total of all reporting groups
11386433|NCT02696031|FG000|Participant Flow|Secukinumab, Load, Core Phase|AIN457 150 mg s.c. load, Core Phase
11386434|NCT02696031|FG001|Participant Flow|Secukinumab, No Load, Core Phase|AIN457 150 mg s.c. no load, Core Phase
11386435|NCT02696031|FG002|Participant Flow|Placebo, Core Phase|Placebo s.c., Core Phase
11386436|NCT02696031|FG003|Participant Flow|AIN457 150 mg Extension Phase|AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 150 mg in the Extension phase (from Week 104 to week 208).
11386437|NCT02696031|FG004|Participant Flow|AIN457 300 mg Extension Phase|AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 300 mg in the Extension phase (from Week 104 to week 208).
11386438|NCT02696031|FG005|Participant Flow|AIN457 300 mg Open Label Extension Phase|AIN457 150 mg Open Label Core Phase Non-Responders who were assigned at week 104 to the 300 mg Open Label in the Extension phase (from Week 104 to week 208).
11386439|NCT02696031|OG000|Outcome|Secukinumab, Load, Core Phase|AIN457 150 mg s.c. load, Core Phase
11386440|NCT02696031|OG001|Outcome|Secukinumab, No Load, Core Phase|AIN457 150 mg s.c. no load, Core Phase
11386441|NCT02696031|OG002|Outcome|Placebo, Core Phase|Placebo s.c., Core Phase
11386442|NCT02696031|EG000|Reported Event|Any AIN457 150 mg, in Core Phase and Extension Phase|Includes patients originally randomized to AIN457 150 mg (Load and No Load) at baseline and placebo patients switched to AIN457 150 mg before or at W52 (AEs occurring after the switch) who either were re-randomized (Core Phase Responders) to AIN457 150 mg at W104 or did not participate in the Extension Phase.
11386443|NCT02696031|EG001|Reported Event|Any AIN457 300 mg in Extension Phase|Includes patients re-randomized (Core Phase Responders) or re-assigned (Core Phase Non-Responders) to AIN457 300 mg at W104 (Extension Phase) and patients re-randomized (Core Phase Responders) to AIN457 150 mg at W104 who up-titrated to AIN457 300 mg (only AEs occurring after up-titration).
11386444|NCT02696031|EG002|Reported Event|Any AIN457, In Core Phase and Extension Phase|Includes patients randomized or switched (AEs occurring after the switch) to AIN457 150 mg (Load and No Load) who either were re-randomized (Core Phase Responders) to AIN457 150 mg or AIN457 300 mg at W104 or did not participate in the Extension Phase.
11386445|NCT02696031|EG003|Reported Event|Placebo, Core Phase|Includes patients originally randomized to Placebo (AEs until the time of a switch to AIN457 150 mg)
11386446|NCT02689453|BG000|Baseline|Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)|"IL-15 for 10 doses over two weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks."
11386447|NCT02689453|BG001|Baseline|Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386448|NCT02689453|BG002|Baseline|Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386449|NCT02689453|BG003|Baseline|Total|Total of all reporting groups
10800090|NCT02614261|BG001|Baseline|Galcanezumab 120mg|"Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
10803576|NCT03417102|FG001|Participant Flow|Fitusiran 80 mg Prophylaxis|Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11386450|NCT02689453|FG000|Participant Flow|Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)|"IL-15 for 10 doses over two weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks."
11386451|NCT02689453|FG001|Participant Flow|Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386452|NCT02689453|FG002|Participant Flow|Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386453|NCT02689453|OG000|Outcome|All Participants|All participants who received at least one dose of subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) followed by Alemtuzumab
11386454|NCT02689453|OG000|Outcome|Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks per dosing schema to determine the maximum tolerated dose (MTD)~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386455|NCT02689453|OG001|Outcome|Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386456|NCT02689453|OG002|Outcome|Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386457|NCT02689453|OG000|Outcome|Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)|"IL-15 for 10 doses over two weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks."
11386458|NCT02689453|EG000|Reported Event|Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks per dosing schema to determine the maximum tolerated dose (MTD)~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386459|NCT02689453|EG001|Reported Event|Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386460|NCT02689453|EG002|Reported Event|Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab|"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks~IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.~alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment."
11386461|NCT02476851|BG000|Baseline|POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly)|Donors in this arm were randomized to have approximately half of their blood collection pass first through the POLFA Needle Assembly, and then through the Kawasumi Needle Assembly.
11386462|NCT02476851|BG001|Baseline|Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly|Donors in this arm were randomized to have approximately half of their blood collection pass first through the Kawasumi Needle Assembly, and then through the POLFA Needle Assembly.
11386463|NCT02476851|BG002|Baseline|Total|Total of all reporting groups
11386464|NCT02476851|FG000|Participant Flow|POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly)|"Ensure that whole blood passed through the POLFA needle assembly (the investigational needle assembly or INA) has a supernatant hemoglobin within the acceptable range of < 100mg/dL. Each subject receives the same intervention (Standard of Care blood draw) and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied."
11386465|NCT02476851|FG001|Participant Flow|Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly)|"Ensure that whole blood passed through the POLFA needle assembly (the investigational needle assembly or INA) has a supernatant hemoglobin within the acceptable range of < 100mg/dL. Each subject receives the same intervention (Standard of Care blood draw) and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied."
11386466|NCT02476851|OG000|Outcome|POLFA (Experimental Needle Assembly)|Blood was drawn through the experimental assembly and the hemoglobin levels were measured.
11386467|NCT02476851|OG001|Outcome|Kawasumi (Control Needle Assembly)|Blood was drawn through the control assembly and the hemoglobin levels were measured.
11386468|NCT02476851|EG000|Reported Event|POLFA (Experimental Needle Assembly)|Blood was drawn through the experimental assembly and the hemoglobin levels were measured.
11386469|NCT02476851|EG001|Reported Event|Kawasumi (Control Needle Assembly)|Blood was drawn through the Control assembly and the hemoglobin levels were measured.
11386470|NCT02389946|BG000|Baseline|Orsiro Sirolimus Coronary Stent System|"Intervention with a Orsiro DES.~Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating."
11386471|NCT02389946|BG001|Baseline|Xience Everolimus Coronary Stent System|"Intervention with a Xience DES.~Xience DES"
11386472|NCT02389946|BG002|Baseline|Total|Total of all reporting groups
11386473|NCT02389946|FG000|Participant Flow|Orsiro Sirolimus Coronary Stent System|"Intervention with a Orsiro DES.~Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating."
11386474|NCT02389946|FG001|Participant Flow|Xience Everolimus Coronary Stent System|"Intervention with a Xience DES.~Xience DES"
11386475|NCT02389946|OG000|Outcome|Orsiro Sirolimus Coronary Stent System|"Intervention with a Orsiro DES.~Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating."
11386476|NCT02389946|OG001|Outcome|Xience Everolimus Coronary Stent System|"Intervention with a Xience DES.~Xience DES"
11386477|NCT02389946|EG000|Reported Event|Orsiro Sirolimus Coronary Stent System|"Intervention with a Orsiro DES.~Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating."
11386478|NCT02389946|EG001|Reported Event|Xience Everolimus Coronary Stent System|"Intervention with a Xience DES.~Xience DES"
11386479|NCT02310919|BG000|Baseline|Low Dose hCG Plus FSH Co-trigger|On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
10800091|NCT02614261|BG002|Baseline|Galcanezumab 240mg|"Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
10800092|NCT02614261|BG003|Baseline|Total|Total of all reporting groups
11386480|NCT02310919|BG001|Baseline|Standard Dose of hCG Alone|On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
11386481|NCT02310919|BG002|Baseline|Total|Total of all reporting groups
11386482|NCT02310919|FG000|Participant Flow|Low Dose hCG Plus FSH Co-trigger|"On the day of ovulation trigger the patient will receive hCG 1,500 IU SQ plus FSH 450 IU SQ~Low dose hCG plus FSH co-trigger: Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger"
11386483|NCT02310919|FG001|Participant Flow|Standard Dose of hCG Alone|"On the day of ovulation trigger the patient will receive standard dose of hCG (10,000 or 5,000 IU SQ)~Standard dose of hCG: Standard dose of hCG (10,000 or 5,000 IU) trigger"
11386484|NCT02310919|OG000|Outcome|Low Dose hCG Plus FSH Co-trigger|On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
11386485|NCT02310919|OG001|Outcome|Standard Dose of hCG Alone|On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
11386486|NCT02310919|OG001|Outcome|Standard Dose of hCG Alone|On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously.
11386487|NCT02310919|EG000|Reported Event|Low Dose hCG Plus FSH Co-trigger|On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
11386488|NCT02310919|EG001|Reported Event|Standard Dose of hCG Alone|On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
11386489|NCT02208024|BG000|Baseline|Stereotactic Body Radiation Therapy|"5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days~Stereotactic Body Radiation Therapy"
11386490|NCT02208024|FG000|Participant Flow|Stereotactic Body Radiation Therapy|"5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days~Stereotactic Body Radiation Therapy"
11386491|NCT02208024|OG000|Outcome|Stereotactic Body Radiation Therapy|"5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days~Stereotactic Body Radiation Therapy"
11386492|NCT02208024|EG000|Reported Event|Stereotactic Body Radiation Therapy|"5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days~Stereotactic Body Radiation Therapy"
11386493|NCT02180867|BG000|Baseline|Dose-Finding Level 1 CR|"Dose-Finding Level 1 CR:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386494|NCT02180867|BG001|Baseline|Dose-Finding Level 1 RT|"Dose-Finding Level 1 RT:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386495|NCT02180867|BG002|Baseline|Dose-Finding Level 2 RT|"Dose-Finding Level 2 RT:~Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2"
11386496|NCT02180867|BG003|Baseline|Regimen A|Regimen A: Chemoradiation plus pazopanib
11386497|NCT02180867|BG004|Baseline|Regimen B|Regimen B: Chemoradiation alone
11386498|NCT02180867|BG005|Baseline|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386499|NCT02180867|BG006|Baseline|Regimen D|Regimen D: Radiation therapy alone
11386500|NCT02180867|BG007|Baseline|Total|Total of all reporting groups
10800093|NCT02614261|FG000|Participant Flow|Placebo|"Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
11386501|NCT02180867|FG000|Participant Flow|Dose-Finding Level 1 CR|"Dose-Finding Level 1 CR:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386502|NCT02180867|FG001|Participant Flow|Dose-Finding Level 1 RT|"Dose-Finding Level 1 RT:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386503|NCT02180867|FG002|Participant Flow|Dose-Finding Level 2 RT|"Dose-Finding Level 2 RT:~Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2"
11386504|NCT02180867|FG003|Participant Flow|Regimen A|Regimen A: Chemoradiation plus pazopanib
11386505|NCT02180867|FG004|Participant Flow|Regimen B|Regimen B: Chemoradiation alone
11386506|NCT02180867|FG005|Participant Flow|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386507|NCT02180867|FG006|Participant Flow|Regimen D|Regimen D: Radiation therapy alone
11386508|NCT02180867|OG000|Outcome|All Pediatric Dose Finding CR Cohorts|Dose-Finding CR: Chemoradiation plus pazopanib
11386509|NCT02180867|OG001|Outcome|All Pediatric Dose Finding RT Cohorts|Dose-Finding RT: Radiation therapy plus pazopanib
11386510|NCT02180867|OG000|Outcome|All Adult Dose Finding CR Cohorts|Dose-Finding CR: Chemoradiation plus pazopanib
11386511|NCT02180867|OG001|Outcome|All Adult Dose Finding RT Cohorts|Dose-Finding RT: Radiation therapy plus pazopanib
11386512|NCT02180867|OG000|Outcome|Dose-Finding Level 1 CR|"Dose-Finding Level 1 CR:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386513|NCT02180867|OG001|Outcome|Regimen A|Regimen A: Chemoradiation plus pazopanib
11386514|NCT02180867|OG002|Outcome|Regimen B|Regimen B: Chemoradiation alone
11386515|NCT02180867|OG000|Outcome|Dose-Finding Level 1 RT|"Dose-Finding Level 1 RT:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386516|NCT02180867|OG001|Outcome|Dose-Finding Level 2 RT|"Dose-Finding Level 2 RT:~Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2"
11386517|NCT02180867|OG002|Outcome|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386518|NCT02180867|OG003|Outcome|Regimen D|Regimen D: Radiation therapy alone
11386519|NCT02180867|OG000|Outcome|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386520|NCT02180867|OG001|Outcome|Regimen D|Regimen D: Radiation therapy alone
11386521|NCT02180867|OG001|Outcome|Dose-Finding Level 1 RT|"Dose-Finding Level 1 RT:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386522|NCT02180867|OG002|Outcome|Dose-Finding Level 2 RT|"Dose-Finding Level 2 RT:~Adult: Pazopanib 800 mg; Pediatric:~Pazopanib 450 mg/m2"
11386523|NCT02180867|OG003|Outcome|Regimen A|Regimen A: Chemoradiation plus pazopanib
11386524|NCT02180867|OG004|Outcome|Regimen B|Regimen B: Chemoradiation alone
11386525|NCT02180867|OG005|Outcome|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386526|NCT02180867|OG006|Outcome|Regimen D|Regimen D: Radiation therapy alone
11386527|NCT02180867|EG000|Reported Event|Dose-Finding Level 1 CR|"Dose-Finding Level 1 CR:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386528|NCT02180867|EG001|Reported Event|Dose-Finding Level 1 RT|"Dose-Finding Level 1 RT:~Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2"
11386529|NCT02180867|EG002|Reported Event|Dose-Finding Level 2 RT|"Dose-Finding Level 2 RT:~Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2"
11386530|NCT02180867|EG003|Reported Event|Regimen A|Regimen A: Chemoradiation plus pazopanib
11386531|NCT02180867|EG004|Reported Event|Regimen B|Regimen B: Chemoradiation alone
11386532|NCT02180867|EG005|Reported Event|Regimen C|Regimen C: Radiation therapy plus pazopanib
11386533|NCT02180867|EG006|Reported Event|Regimen D|Regimen D: Radiation therapy alone
11386534|NCT01866111|BG000|Baseline|Placebo|Subjects treated with identical appearing study drug.
11386535|NCT01866111|BG001|Baseline|Cenobamate 100 mg/Day|Subjects titrated to a target dose of 100 mg/day
11386536|NCT01866111|BG002|Baseline|Cenobamate 200 mg/Day|Subjects titrated to a target dose of 200 mg/day
11386537|NCT01866111|BG003|Baseline|Cenobamate 400 mg/Day|Subjects titrated to a target dose of 400 mg/day
11386538|NCT01866111|BG004|Baseline|Total|Total of all reporting groups
11386539|NCT01866111|FG000|Participant Flow|Placebo|Subjects treated with identical appearing study drug.
11386540|NCT01866111|FG001|Participant Flow|Cenobamate 100 mg/Day|Subjects titrated to a target dose of 100 mg/day
11386541|NCT01866111|FG002|Participant Flow|Cenobamate 200 mg/Day|Subjects titrated to a target dose of 200 mg/day
11386542|NCT01866111|FG003|Participant Flow|Cenobamate 400 mg/Day|Subjects titrated to a target dose of 400 mg/day
11386543|NCT01866111|OG000|Outcome|Placebo|Subjects treated with identical appearing study drug.
11386544|NCT01866111|OG001|Outcome|Cenobamate 100 mg/Day|Subjects titrated to a target dose of 100 mg/day
11386545|NCT01866111|OG002|Outcome|Cenobamate 200 mg/Day|Subjects titrated to a target dose of 200 mg/day
11386546|NCT01866111|OG003|Outcome|Cenobamate 400 mg/Day|Subjects titrated to a target dose of 400 mg/day
11386547|NCT01866111|EG000|Reported Event|Placebo|Subjects treated with identical appearing study drug.
11386548|NCT01866111|EG001|Reported Event|Cenobamate 100 mg/Day|Subjects titrated to a target dose of 100 mg/day
11386549|NCT01866111|EG002|Reported Event|Cenobamate 200 mg/Day|Subjects titrated to a target dose of 200 mg/day
11386550|NCT01866111|EG003|Reported Event|Cenobamate 400 mg/Day|Subjects titrated to a target dose of 400 mg/day
11386551|NCT01767129|BG000|Baseline|All Study Participants|Participants were randomized to receive AVP-923-45 (45 milligrams [mg] dextromethorphan hydrobromide [DM]/10 mg quinidine sulfate [Q]) and placebo in one of two treatment sequences: AVP-923-45 in Treatment Period 1, placebo in Treatment Period 2; or placebo in Treatment Period 1, AVP-923-45 in Treatment Period 2. The two treatment periods were separated by a 14-day washout period. In both treatment periods, participants received either one AVP-923-45 capsule or one placebo capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days.
11386552|NCT01767129|FG000|Participant Flow|AVP-923-45; Placebo|In Treatment Period 1, participants received one AVP-923-45 (45 milligrams [mg] dextromethorphan hydrobromide [DM]/10 mg quinidine sulfate [Q]) capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days. In Treatment Period 2, participants received one placebo capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days. The two treatment periods were separated by a 14-day washout period.
11386553|NCT01767129|FG001|Participant Flow|Placebo; AVP-923-45|In Treatment Period 1, participants received one placebo capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days. In Treatment Period 2, participants received one AVP-923-45 capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days. The two treatment periods were separated by a 14-day washout period.
11386554|NCT01767129|OG000|Outcome|AVP-923-45|Participants received one AVP-923-45 capsule (45 milligrams [mg] dextromethorphan hydrobromide [DM]/10 mg quinidine sulfate [Q]) once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days in either Treatment Period 1 or Treatment Period 2. The two treatment periods were separated by a 14-day washout period.
11386555|NCT01767129|OG001|Outcome|Placebo|Participants received one placebo capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days in either Treatment Period 1 or Treatment Period 2. The two treatment periods were separated by a 14-day washout period.
11386556|NCT01767129|OG000|Outcome|AVP-923-45|Participants received one AVP-923-45 capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days in either Treatment Period 1 or Treatment Period 2. The two treatment periods were separated by a 14-day washout period.
11386557|NCT01767129|EG000|Reported Event|AVP-923-45|Participants received one AVP-923-45 capsule (45 milligrams [mg] dextromethorphan hydrobromide [DM]/10 mg quinidine sulfate [Q]) once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days in either Treatment Period 1 or Treatment Period 2. The two treatment periods were separated by a 14-day washout period.
11386558|NCT01767129|EG001|Reported Event|Placebo|Participants received one placebo capsule once daily in the morning for 3 days, then twice daily, approximately 12 hours apart, for 11 days in either Treatment Period 1 or Treatment Period 2. The two treatment periods were separated by a 14-day washout period.
11386559|NCT01622868|BG000|Baseline|Radiation Therapy|Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)
11386560|NCT01622868|BG001|Baseline|Lapatinib and Radiation Therapy|1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))
11386561|NCT01622868|BG002|Baseline|Total|Total of all reporting groups
11386562|NCT01622868|FG000|Participant Flow|Radiation Therapy|Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)
11386563|NCT01622868|FG001|Participant Flow|Lapatinib and Radiation Therapy|1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))
11386564|NCT01622868|OG000|Outcome|Radiation Therapy|Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)
11386565|NCT01622868|OG001|Outcome|Lapatinib and Radiation Therapy|1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))
11386566|NCT01622868|EG000|Reported Event|Radiation Therapy|Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)
11386567|NCT01622868|EG001|Reported Event|Lapatinib and Radiation Therapy|1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))
11386568|NCT01609790|BG000|Baseline|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386569|NCT01609790|BG001|Baseline|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
11386570|NCT01609790|BG002|Baseline|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386571|NCT01609790|BG003|Baseline|Total|Total of all reporting groups
11197113|NCT02169414|EG002|Reported Event|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197114|NCT02169414|EG003|Reported Event|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
11197115|NCT02169427|BG000|Baseline|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
11197116|NCT02169427|FG000|Participant Flow|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
11197117|NCT02169427|OG000|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
11197118|NCT02169427|EG000|Reported Event|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
11197119|NCT02169440|BG000|Baseline|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
11197120|NCT02169440|BG001|Baseline|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
11197121|NCT02169440|BG002|Baseline|Total|Total of all reporting groups
10803577|NCT03417102|OG000|Outcome|Bypassing Agents (BPA) On-demand|Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11197122|NCT02169440|FG000|Participant Flow|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
11197123|NCT02169440|FG001|Participant Flow|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
11197124|NCT02169440|OG000|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
11197125|NCT02169440|OG000|Outcome|Warfarin Alone|Warfarin 25 mg
11197126|NCT02169440|OG000|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
11197127|NCT02169440|EG000|Reported Event|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg Warfarin 25 mg
11197128|NCT02169440|EG001|Reported Event|Warfarin|Warfarin 25 mg
11197129|NCT02169453|BG000|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197130|NCT02169453|BG001|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197131|NCT02169453|BG002|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197132|NCT02169453|BG003|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197133|NCT02169453|BG004|Baseline|Total|Total of all reporting groups
11197134|NCT02169453|FG000|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197135|NCT02169453|FG001|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197136|NCT02169453|FG002|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197137|NCT02169453|FG003|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
11197138|NCT02169453|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197139|NCT02169453|OG001|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
10803578|NCT03417102|OG001|Outcome|Fitusiran 80 mg Prophylaxis|Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11386572|NCT01609790|FG000|Participant Flow|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386573|NCT01609790|FG001|Participant Flow|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
11386574|NCT01609790|FG002|Participant Flow|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386575|NCT01609790|OG000|Outcome|Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386576|NCT01609790|OG000|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
11386577|NCT01609790|OG001|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386578|NCT01609790|EG000|Reported Event|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386579|NCT01609790|EG001|Reported Event|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
11386580|NCT01609790|EG002|Reported Event|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
11386581|NCT01586910|BG000|Baseline|Medtronic CoreValve® System TAVI|"Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)"
11386582|NCT01586910|BG001|Baseline|SAVR|Surgical Aortic Valve Replacement (SAVR)
11386583|NCT01586910|BG002|Baseline|Total|Total of all reporting groups
11386584|NCT01586910|FG000|Participant Flow|Medtronic CoreValve® System TAVI|"Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)"
11386585|NCT01586910|FG001|Participant Flow|SAVR|Surgical Aortic Valve Replacement (SAVR)
11386586|NCT01586910|OG000|Outcome|Medtronic CoreValve® System TAVI|"Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)"
11386587|NCT01586910|OG001|Outcome|SAVR|Surgical Aortic Valve Replacement (SAVR)
11386588|NCT01586910|OG000|Outcome|Medtronic CoreValve® System TAVI|"Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)"
11386589|NCT01586910|OG000|Outcome|Medtronic CoreValve® System TAVI|Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
11386590|NCT01586910|EG000|Reported Event|Medtronic CoreValve® System TAVI|"Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)"
11386591|NCT01586910|EG001|Reported Event|SAVR|Surgical Aortic Valve Replacement (SAVR)
11386592|NCT01236560|BG000|Baseline|Feasibility (Vorinostat)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at 230 mg/m2/day. In the event of 2 or more DLTs, participants will de-escalate to vorinostat at 180 mg/m2/day. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386593|NCT01236560|BG001|Baseline|Arm I (Vorinostat, Phase II Arm A)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386594|NCT01236560|BG002|Baseline|Arm II (Temozolomide, Phase II Arm B)|"Patients undergo RT as in the feasibility arm and receive temozolomide PO once daily for 42 days by day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386595|NCT01236560|BG003|Baseline|Arm III (Bevacizumab, Phase II Arm C)|"Patients undergo RT as in the feasibility arm and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386596|NCT01236560|BG004|Baseline|Arm IV (Temozolomide, Phase III Arm B)|"Patients undergo RT as in the Arm II and receive temozolomide PO once daily for 42 days beginning on day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386597|NCT01236560|BG005|Baseline|Arm V (Vorinostat/Bevacizumab, Phase III, Chemoradiotherapy|"Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as superior in phase II. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386598|NCT01236560|BG006|Baseline|Total|Total of all reporting groups
11386599|NCT01236560|FG000|Participant Flow|Feasibility (Vorinostat)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at 230 mg/m2/day. In the event of 2 or more DLTs, participants will de-escalate to vorinostat at 180 mg/m2/day. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11197140|NCT02169453|OG002|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197141|NCT02169453|OG003|Outcome|Placebo|Placebo, PLC
11197142|NCT02169453|EG000|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197143|NCT02169453|EG001|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
11386600|NCT01236560|FG001|Participant Flow|Arm I (Vorinostat, Phase II Arm A)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386601|NCT01236560|FG002|Participant Flow|Arm II (Temozolomide, Phase II Arm B)|"Patients undergo RT as in the feasibility arm and receive temozolomide PO once daily for 42 days by day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386602|NCT01236560|FG003|Participant Flow|Arm III (Bevacizumab, Phase II Arm C)|"Patients undergo RT as in the feasibility arm and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386603|NCT01236560|FG004|Participant Flow|Arm IV (Temozolomide, Phase III Arm B)|"Patients undergo RT as in the Arm II and receive temozolomide PO once daily for 42 days beginning on day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386604|NCT01236560|FG005|Participant Flow|Arm V (Vorinostat/Bevacizumab, Phase III, Chemoradiotherapy|"Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as superior in phase II. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386605|NCT01236560|OG000|Outcome|Feasibility (Vorinostat)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at 230 mg/m2/day. In the event of 2 or more DLTs, participants will de-escalate to vorinostat at 180 mg/m2/day. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386606|NCT01236560|OG001|Outcome|Arm I (Vorinostat, Phase II Arm A)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386607|NCT01236560|OG002|Outcome|Arm II (Temozolomide, Phase II Arm B)|"Patients undergo RT as in the feasibility arm and receive temozolomide PO once daily for 42 days by day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386608|NCT01236560|OG003|Outcome|Arm III (Bevacizumab, Phase II Arm C)|"Patients undergo RT as in the feasibility arm and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386609|NCT01236560|EG000|Reported Event|Feasibility (Vorinostat)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at 230 mg/m2/day. In the event of 2 or more DLTs, participants will de-escalate to vorinostat at 180 mg/m2/day. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386610|NCT01236560|EG001|Reported Event|Arm I (Vorinostat, Phase II Arm A)|"Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO~Vorinostat: Given PO"
11386611|NCT01236560|EG002|Reported Event|Arm II (Temozolomide, Phase II Arm B)|"Patients undergo RT as in the feasibility arm and receive temozolomide PO once daily for 42 days by day 5 of RT. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386612|NCT01236560|EG003|Reported Event|Arm III (Bevacizumab, Phase II Arm C)|"Patients undergo RT as in the feasibility arm and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients receive Maintenance therapy of bevacizumab 10mg/kg/dose every 2 weeks and temozolomide 200 mg/m2/dose Days 1-5, for up to twelve cycles in the absence of progressive disease and unacceptable toxicities.~Bevacizumab: Given IV~Temozolomide: Given PO"
11386613|NCT01236547|BG000|Baseline|(Run-in 1) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT.~Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.~Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy"
11386614|NCT01236547|BG001|Baseline|(Run-in 2) Pazopanib, Paclitaxil, IMRT|"Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386615|NCT01236547|BG002|Baseline|(Run-in 3) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11197144|NCT02169453|EG002|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197145|NCT02169453|EG003|Reported Event|Placebo|Placebo, PLC
11197146|NCT02169466|BG000|Baseline|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197147|NCT02169466|BG001|Baseline|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197148|NCT02169466|BG002|Baseline|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197149|NCT02169466|BG003|Baseline|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197150|NCT02169466|BG004|Baseline|Total|Total of all reporting groups
11197151|NCT02169466|FG000|Participant Flow|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197152|NCT02169466|FG001|Participant Flow|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197153|NCT02169466|FG002|Participant Flow|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197154|NCT02169466|FG003|Participant Flow|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
11197155|NCT02169466|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
11197156|NCT02169466|OG001|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
11197157|NCT02169466|OG002|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197158|NCT02169466|OG003|Outcome|Placebo|Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
11197159|NCT02169466|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
11197160|NCT02169466|OG003|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
11197161|NCT02169466|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197162|NCT02169466|OG003|Outcome|Placebo|Placebo, PLC
11197163|NCT02169466|EG000|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197164|NCT02169466|EG001|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
11197165|NCT02169466|EG002|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197166|NCT02169466|EG003|Reported Event|Placebo|Placebo, PLC
11197167|NCT02169479|BG000|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197168|NCT02169479|BG001|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197169|NCT02169479|BG002|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197170|NCT02169479|BG003|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11386616|NCT01236547|BG003|Baseline|(Phase II) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386617|NCT01236547|BG004|Baseline|(Phase II) Placebo, Paclitaxel, IMRT|"Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386618|NCT01236547|BG005|Baseline|Total|Total of all reporting groups
11386619|NCT01236547|FG000|Participant Flow|(Run-in 1) Pazopanib, Paclitaxel, IMRT|"Pre-Intensity-modulated radiation therapy (IMRT) pazopanib 800 mg oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT.~Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease."
11386620|NCT01236547|FG001|Participant Flow|(Run-in 2) Pazopanib, Paclitaxil, IMRT|"Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386621|NCT01236547|FG002|Participant Flow|(Run-in 3) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386622|NCT01236547|FG003|Participant Flow|(Phase II) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386623|NCT01236547|FG004|Participant Flow|(Phase II) Placebo, Paclitaxel, IMRT|"Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386624|NCT01236547|OG000|Outcome|(Phase II) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386625|NCT01236547|OG001|Outcome|(Phase II) Placebo, Paclitaxel, IMRT|"Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386626|NCT01236547|OG000|Outcome|(Run-in 1) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT.~Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease."
11386627|NCT01236547|OG001|Outcome|(Run-in 2) Pazopanib, Paclitaxil, IMRT|"Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386628|NCT01236547|OG002|Outcome|(Run-in 3) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386629|NCT01236547|OG003|Outcome|(Phase II) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT.~Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy"
10803579|NCT03417102|EG000|Reported Event|Bypassing Agents (BPA) On-demand|Participants received On-demand BPAs (use of these agents, as needed, for episodic bleeding episodes, and not on a regular regimen intended to prevent spontaneous bleeding) per Investigator discretion from Day 1 for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11197171|NCT02169479|BG004|Baseline|Total|Total of all reporting groups
11386630|NCT01236547|EG000|Reported Event|(Run-in 1) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT.~Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease."
11386631|NCT01236547|EG001|Reported Event|(Run-in 2) Pazopanib, Paclitaxil, IMRT|"Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386632|NCT01236547|EG002|Reported Event|(Run-in 3) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386633|NCT01236547|EG003|Reported Event|(Phase II) Pazopanib, Paclitaxel, IMRT|"Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386634|NCT01236547|EG004|Reported Event|(Phase II) Placebo, Paclitaxel, IMRT|"Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m^2 IV weekly for 2-3 weeks.~Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m^2 IV weekly during 6.5 weeks of IMRT."
11386635|NCT01062425|BG000|Baseline|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
11386636|NCT01062425|BG001|Baseline|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
11386637|NCT01062425|BG002|Baseline|Total|Total of all reporting groups
11386638|NCT01062425|FG000|Participant Flow|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
11197172|NCT02169479|FG000|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197173|NCT02169479|FG001|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197174|NCT02169479|FG002|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197175|NCT02169479|FG003|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
11197176|NCT02169479|OG000|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197177|NCT02169479|OG001|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
11197178|NCT02169479|OG002|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197179|NCT02169479|OG003|Outcome|Placebo|Placebo, PLC
11197180|NCT02169479|EG000|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
11197181|NCT02169479|EG001|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
11197182|NCT02169479|EG002|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
11197183|NCT02169479|EG003|Reported Event|Placebo|Placebo, PLC
11197184|NCT02169505|BG000|Baseline|Safety and Efficacy of Brentuximab Vedotin Maintenance After A|Study the safety of Brentuximab in patients with HL or ALCL who have had an allo or haplo stem cell transplant. Also learn if drug prevents the disease from coming back.
11197185|NCT02169505|FG000|Participant Flow|Safety and Efficacy of Brentuximab Vedotin Maintenance After A|Study the safety of Brentuximab in patients with HL or ALCL who have had an allo or haplo stem cell transplant. Also learn if drug prevents the disease from coming back.
11197186|NCT02169505|OG000|Outcome|1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6|"Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:~Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.~Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.~Dose will be reduced to 1 mg/kg if:~Creatinine clearance < 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml~Hepatic impairment defined as bilirubin > 2 mg/dL.~If the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade </= 1 and restart at lower dose."
11197187|NCT02169505|EG000|Reported Event|Treatment Arm|1.2 mg/kg for C1-2 then 1.8mg/kg for C3-6
11197188|NCT02169674|BG000|Baseline|10-11 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197189|NCT02169674|BG001|Baseline|15-16 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197190|NCT02169674|BG002|Baseline|Total|Total of all reporting groups
11197191|NCT02169674|FG000|Participant Flow|10-11 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11386639|NCT01062425|FG001|Participant Flow|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
11197192|NCT02169674|FG001|Participant Flow|15-16 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197193|NCT02169674|OG000|Outcome|10-11 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197194|NCT02169674|OG001|Outcome|15-16 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197195|NCT02169674|EG000|Reported Event|10-11 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197196|NCT02169674|EG001|Reported Event|15-16 Year-olds|Single challenge dose of HBV vaccine (10 mcg, Engerix B, GSK)
11197197|NCT02169739|BG000|Baseline|Medical Therapy Only|Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
11197198|NCT02169739|BG001|Baseline|Ischemic Preconditioning + Medical|"Patients will receive treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year. The procedure will consist of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients will also receive intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.~Ischemic Preconditioning: Patients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion."
11197199|NCT02169739|BG002|Baseline|Total|Total of all reporting groups
11197200|NCT02169739|FG000|Participant Flow|Medical Therapy Only|Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
11197201|NCT02169739|FG001|Participant Flow|Ischemic Preconditioning + Medical|Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
11386640|NCT01062425|OG000|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
11386641|NCT01062425|OG001|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
11386642|NCT01062425|EG000|Reported Event|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
11386643|NCT01062425|EG001|Reported Event|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
11386644|NCT00559936|BG000|Baseline|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
11386645|NCT00559936|FG000|Participant Flow|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
11386646|NCT00559936|OG000|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
11386647|NCT00559936|EG000|Reported Event|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
11386648|NCT00504582|BG000|Baseline|Treatment Arm|Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
11386649|NCT00504582|BG001|Baseline|Control Arm|No Intervention: No Fibrin Sealant
11386650|NCT00504582|BG002|Baseline|Questionnaire Only|Questionnaire only
11386651|NCT00504582|BG003|Baseline|Total|Total of all reporting groups
11386652|NCT00504582|FG000|Participant Flow|Treatment Arm|Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
11197202|NCT02169739|OG000|Outcome|Ischemic Preconditioning + Medical|Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
11197203|NCT02169739|OG000|Outcome|Medical Therapy Only|Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
11386653|NCT00504582|FG001|Participant Flow|Control Arm|No Intervention: No Fibrin Sealant
11386654|NCT00504582|FG002|Participant Flow|Questionnaire Only|Questionnaire only
11386655|NCT00504582|OG000|Outcome|Treatment Arm|Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
11386656|NCT00504582|OG001|Outcome|Control Arm|No Intervention: No Fibrin Sealant
11386657|NCT00504582|OG002|Outcome|Questionnaire Only|Questionnaire Only
11386658|NCT00504582|EG000|Reported Event|Treatment Arm|Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
11386659|NCT00504582|EG001|Reported Event|Control Arm|No Intervention: No Fibrin Sealant
11386660|NCT00504582|EG002|Reported Event|Questionnaire Only|Questionnaire Only
11386661|NCT02255487|BG000|Baseline|Irrisept|For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
11386662|NCT02255487|BG001|Baseline|Standard of Care (SoC)|For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
11386663|NCT02255487|BG002|Baseline|Total|Total of all reporting groups
11386664|NCT02255487|FG000|Participant Flow|Irrisept|"For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.~Irrisept consists of two containers: (1) a sterile bottle of 450 mL of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% sterile water and (2) a sterile bottle of 450 mL of sterile 0.9% normal saline."
11386665|NCT02255487|FG001|Participant Flow|Standard of Care (SoC)|For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.
11386666|NCT02255487|OG000|Outcome|Irrisept|For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
11386667|NCT02255487|OG001|Outcome|Standard of Care (SoC)|For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.
11386668|NCT02255487|OG001|Outcome|Standard of Care (SoC)|For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.
11386669|NCT02255487|EG000|Reported Event|Irrisept|For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
11386670|NCT02255487|EG001|Reported Event|Standard of Care (SoC)|For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.
11197204|NCT02169739|OG001|Outcome|Ischemic Preconditioning + Medical|Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
11197205|NCT02169739|EG000|Reported Event|Medical Therapy Only|Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
11386671|NCT02257918|BG000|Baseline|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
11386672|NCT02257918|BG001|Baseline|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
11386673|NCT02257918|BG002|Baseline|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
11386674|NCT02257918|BG003|Baseline|Total|Total of all reporting groups
11386675|NCT02257918|FG000|Participant Flow|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
11386676|NCT02257918|FG001|Participant Flow|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
11386677|NCT02257918|FG002|Participant Flow|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
11386678|NCT02257918|OG000|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
11386679|NCT02257918|OG001|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
11386680|NCT02257918|OG002|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
11386681|NCT02257918|EG000|Reported Event|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
11386682|NCT02257918|EG001|Reported Event|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
11386683|NCT02257918|EG002|Reported Event|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
11386684|NCT02258542|BG000|Baseline|SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386685|NCT02258542|BG001|Baseline|SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386686|NCT02258542|BG002|Baseline|ZONDA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386687|NCT02258542|BG003|Baseline|ZONDA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386688|NCT02258542|BG004|Baseline|Total|Total of all reporting groups
11386689|NCT02258542|FG000|Participant Flow|SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386690|NCT02258542|FG001|Participant Flow|SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386691|NCT02258542|FG002|Participant Flow|ZONDA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386692|NCT02258542|FG003|Participant Flow|ZONDA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386693|NCT02258542|OG000|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386694|NCT02258542|OG001|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386695|NCT02258542|OG002|Outcome|ZONDA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386696|NCT02258542|OG003|Outcome|ZONDA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386697|NCT02258542|OG000|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4|Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
11386698|NCT02258542|OG001|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo|Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
11386699|NCT02258542|OG002|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386700|NCT02258542|OG003|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8|Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
11386701|NCT02258542|OG004|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo|Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
11386702|NCT02258542|OG005|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386703|NCT02258542|OG006|Outcome|ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4|Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
11386704|NCT02258542|OG007|Outcome|ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo|Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
11386705|NCT02258542|OG008|Outcome|ZONDA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11386706|NCT02258542|OG009|Outcome|ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8|Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
11386707|NCT02258542|OG010|Outcome|ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo|Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
11386708|NCT02258542|OG011|Outcome|ZONDA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11386709|NCT02258542|OG002|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8|Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
11386710|NCT02258542|OG003|Outcome|SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo|Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
11386711|NCT02258542|OG004|Outcome|ZONDA - Benra 30 mg q.4 Weeks - Pre Benra q.4|Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
11386712|NCT02258542|OG005|Outcome|ZONDA - Benra 30 mg q.4 wk - Predecessor Placebo|Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
11386713|NCT02258542|OG006|Outcome|ZONDA - Benra 30 mg q.8 Weeks - Pre Benra q.8|Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
11386714|NCT02258542|OG007|Outcome|ZONDA - Benra 30 mg q.8 wk - Predecessor Placebo|Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
11386715|NCT02258542|EG000|Reported Event|SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 Weeks
11386716|NCT02258542|EG001|Reported Event|SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 Weeks
11386717|NCT02258542|EG002|Reported Event|ZONDA - Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 Weeks
11386718|NCT02258542|EG003|Reported Event|ZONDA - Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 Weeks
11386719|NCT02290431|BG000|Baseline|LBH589 + Bortezomib + Dexamethasone|Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
11386720|NCT02290431|FG000|Participant Flow|LBH589 + Bortezomib + Dexamethasone|Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
11386721|NCT02290431|OG000|Outcome|LBH589 + Bortezomib + Dexamethasone|Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
11386722|NCT02290431|EG000|Reported Event|LBH589 + Bortezomib + Dexamethasone|Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
11386723|NCT02314923|BG000|Baseline|3x10^3 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0
11386724|NCT02314923|BG001|Baseline|3x10^4 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
11386725|NCT02314923|BG002|Baseline|3x10^5 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
11386726|NCT02314923|BG003|Baseline|3x10^6 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
11386727|NCT02314923|BG004|Baseline|Placebo Cohort 1|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
11386728|NCT02314923|BG005|Baseline|3x10^6 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
11386729|NCT02314923|BG006|Baseline|9x10^6 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
11386730|NCT02314923|BG007|Baseline|2x10^7 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
11386731|NCT02314923|BG008|Baseline|1x10^8 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
11386732|NCT02314923|BG009|Baseline|Placebo: Cohort 2|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
11386733|NCT02314923|BG010|Baseline|Total|Total of all reporting groups
11386734|NCT02314923|FG000|Participant Flow|3x10^3 Plaque-forming Units (Pfu) V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
11386735|NCT02314923|FG001|Participant Flow|3x10^4 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
11386736|NCT02314923|FG002|Participant Flow|3x10^5 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
11386737|NCT02314923|FG003|Participant Flow|3x10^6 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
11386738|NCT02314923|FG004|Participant Flow|Placebo: Cohort 1|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
11386739|NCT02314923|FG005|Participant Flow|3x10^6 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
11386740|NCT02314923|FG006|Participant Flow|9x10^6 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
11386741|NCT02314923|FG007|Participant Flow|2x10^7 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
11386742|NCT02314923|FG008|Participant Flow|1x10^8 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
11386743|NCT02314923|FG009|Participant Flow|Placebo: Cohort 2|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
11386744|NCT02314923|OG000|Outcome|3x10^3 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
11386745|NCT02314923|OG001|Outcome|3x10^4 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
11386746|NCT02314923|OG002|Outcome|3x10^5 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
11386747|NCT02314923|OG003|Outcome|3x10^6 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
11386748|NCT02314923|OG004|Outcome|Placebo: Cohort 1|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
11386749|NCT02314923|OG005|Outcome|3x10^6 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
11386750|NCT02314923|OG006|Outcome|9x10^6 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
11386751|NCT02314923|OG007|Outcome|2x10^7 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
11386752|NCT02314923|OG008|Outcome|1x10^8 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
11386753|NCT02314923|OG009|Outcome|Placebo: Cohort 2|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
11386754|NCT02314923|OG000|Outcome|All Vaccinated Participants|All participants that received study vaccine.
11386755|NCT02314923|EG000|Reported Event|3x10^3 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
11386756|NCT02314923|EG001|Reported Event|3x10^4 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
11386757|NCT02314923|EG002|Reported Event|3x10^5 Pfu V920: Cohort 1|Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
11386758|NCT02314923|EG003|Reported Event|3x10^6 Pfu V920: Cohort 1|Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
11386759|NCT02314923|EG004|Reported Event|Placebo: Cohort 1|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
11386760|NCT02314923|EG005|Reported Event|3x10^6 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
11386761|NCT02314923|EG006|Reported Event|9x10^6 Pfu V920: Cohort 2|Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
11386762|NCT02314923|EG007|Reported Event|2x10^7 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
11386763|NCT02314923|EG008|Reported Event|1x10^8 Pfu V920: Cohort 2|Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
11386764|NCT02314923|EG009|Reported Event|Placebo: Cohort 2|Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
11197206|NCT02169739|EG001|Reported Event|Ischemic Preconditioning + Medical|"Patients will receive treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year. The procedure will consist of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients will also receive intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.~Ischemic Preconditioning: Patients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion."
11197207|NCT02169791|BG000|Baseline|Haploidentical Transplant|"All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.~MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant."
11197208|NCT02169791|FG000|Participant Flow|Haploidentical Transplant|"All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.~MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant."
11197209|NCT02169791|OG000|Outcome|Haploidentical Transplant|"All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.~MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant."
11197210|NCT02169791|EG000|Reported Event|Haploidentical Transplant|"All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.~MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant."
11386765|NCT04821362|BG000|Baseline|Standard Technique Group|In this group, peripheral intravenous catheter insertion will be performed routinely.
11386766|NCT04821362|BG001|Baseline|Ultrasound Group|"In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.~Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe."
11386767|NCT04821362|BG002|Baseline|Near Infrared Device Group|"In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.~Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400."
11386768|NCT04821362|BG003|Baseline|Total|Total of all reporting groups
11386769|NCT04821362|FG000|Participant Flow|Standard Technique Group|In this group, peripheral intravenous catheter insertion will be performed routinely.
11386770|NCT04821362|FG001|Participant Flow|Ultrasound Group|"In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.~Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe."
11386771|NCT04821362|FG002|Participant Flow|Near Infrared Device Group|"In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.~Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400."
11386772|NCT04821362|OG000|Outcome|Standard Technique Group|In this group, peripheral intravenous catheter insertion will be performed routinely.
11386773|NCT04821362|OG001|Outcome|Ultrasound Group|"In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.~Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe."
11386774|NCT04821362|OG002|Outcome|Near Infrared Device Group|"In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.~Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400."
11386775|NCT04821362|OG000|Outcome|Standard Technique Group|The number of patients who need a rescue method in patients who cannot achieve success with the standard method
11386776|NCT04821362|OG001|Outcome|Ultrasound Group|The number of patients who need a rescue method in patients who cannot achieve success with the ultrasound method.
11386777|NCT04821362|OG002|Outcome|Near Infrared Device Group|The number of patients who need a rescue method in patients who cannot achieve success with the near infrared method
11386778|NCT04821362|EG000|Reported Event|Standard Technique Group|In this group, peripheral intravenous catheter insertion will be performed routinely.
11386779|NCT04821362|EG001|Reported Event|Ultrasound Group|"In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.~Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe."
11386780|NCT04821362|EG002|Reported Event|Near Infrared Device Group|"In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.~Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400."
11386810|NCT04166214|EG000|Reported Event|Dental Providers|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386811|NCT04166214|EG001|Reported Event|Dental Patients|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386812|NCT03947788|BG000|Baseline|Interventional Practices|"The staff at these two clinics which included physicians, clinical and administrative staff; received the One Key Question in-person training program, delivered by Power to Decide.~OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care."
11386813|NCT03947788|BG001|Baseline|Control Practices|These two clinics did not receive the One Key Question training program during the study period. They were offered the training after the study period was over.
11386814|NCT03947788|BG002|Baseline|Total|Total of all reporting groups
11386815|NCT03947788|FG000|Participant Flow|Interventional Practices|"These clinics, including physicians, clinical and administrative staff, will receive the One Key Question training program, delivered by Power to Decide, via an in-person group training session.~OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care."
11386816|NCT03947788|FG001|Participant Flow|Control Practices|These clinics will not receive the OKQ training program during the study period. They will have the opportunity to receive the training after the study period is over.
11386817|NCT03947788|OG000|Outcome|Interventional Practices|"Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).~Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks."
11386818|NCT03947788|OG001|Outcome|Control Practices|"Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).~Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program."
11386819|NCT03947788|OG000|Outcome|Interventional Practices|"Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (did not receive One Key Question training program).~Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks."
11386781|NCT04524507|BG000|Baseline|High-Titer (CCP1)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment.~High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386782|NCT04524507|BG001|Baseline|Standard-Titer (CCP2)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment.~Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386783|NCT04524507|BG002|Baseline|Total|Total of all reporting groups
11386784|NCT04524507|FG000|Participant Flow|High-Titer (CCP1)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment.~High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386785|NCT04524507|FG001|Participant Flow|Standard-Titer (CCP2)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment.~Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386786|NCT04524507|OG000|Outcome|High-Titer (CCP1)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment.~High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386787|NCT04524507|OG001|Outcome|Standard-Titer (CCP2)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment.~Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386788|NCT04524507|EG000|Reported Event|High-Titer (CCP1)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment.~High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386789|NCT04524507|EG001|Reported Event|Standard-Titer (CCP2)|"Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment.~Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available."
11386790|NCT04382924|BG000|Baseline|Treatment Arm A|NP-120 (Ifenprodil) 20 mg TID + Standard of Care
11386791|NCT04382924|BG001|Baseline|Treatment Arm B|NP-120 (Ifenprodil) 40 mg TID + Standard of Care
11386792|NCT04382924|BG002|Baseline|Control Arm|Standard of Care only
11386793|NCT04382924|BG003|Baseline|Total|Total of all reporting groups
11386794|NCT04382924|FG000|Participant Flow|Treatment Arm A|NP-120 (Ifenprodil) 20 mg TID + Standard of Care
11386795|NCT04382924|FG001|Participant Flow|Treatment Arm B|NP-120 (Ifenprodil) 40 mg TID + Standard of Care
11386796|NCT04382924|FG002|Participant Flow|Control Arm|Standard of Care only
11386797|NCT04382924|OG000|Outcome|Treatment Arm A|NP-120 (Ifenprodil) 20 mg TID + Standard of Care
11386798|NCT04382924|OG001|Outcome|Treatment Arm B|NP-120 (Ifenprodil) 40 mg TID + Standard of Care
11386799|NCT04382924|OG002|Outcome|Control Arm|Standard of Care only
11386800|NCT04382924|EG000|Reported Event|Treatment Arm A|NP-120 (Ifenprodil) 20 mg TID + Standard of Care
11386801|NCT04382924|EG001|Reported Event|Treatment Arm B|NP-120 (Ifenprodil) 40 mg TID + Standard of Care
11386802|NCT04382924|EG002|Reported Event|Control Arm|Standard of Care only
11386803|NCT04166214|BG000|Baseline|Dental Providers|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386804|NCT04166214|BG001|Baseline|Dental Patients|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386805|NCT04166214|BG002|Baseline|Total|Total of all reporting groups
11386806|NCT04166214|FG000|Participant Flow|Dental Providers|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386807|NCT04166214|FG001|Participant Flow|Dental Patients|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386808|NCT04166214|OG000|Outcome|Dental Patients|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386809|NCT04166214|OG000|Outcome|Dental Providers|The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
11386820|NCT03947788|OG000|Outcome|Interventional Practices, Clinics Receiving One Key Question Training|"Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received One Key Question training program).~Patients at the intervention practices were surveyed to determine if there was an improved rate of received preconception counseling, following each clinic's implementation of the intervention for 4-6 weeks."
11386821|NCT03947788|OG001|Outcome|Control Practices, Clinics Not Receiving One Key Question Training|"Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).~Patients at the control practices were surveyed to demonstrate that preconception counseling rates remained unchanged at clinics not receiving the One Key Question training program."
11386822|NCT03947788|OG000|Outcome|Interventional Practices|"The intervention group consisted of two clinics (one Family Medicine, one OB/GYN), where physicians and staff received the One Key Question training program, delivered by Power to Decide, via an in-person group training session.~OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.~Patients at the two clinics were surveyed to determine if patient satisfaction increased following the clinics' implementation of the One Key Question program for 4-6 weeks."
11386823|NCT03947788|OG001|Outcome|Control Practices|"The control group consisted of two clinics (one Family Medicine, one OB/GYN), that did not receive the intervention (the One Key Question training program).~Patients at the two clinics in the control group were surveyed to demonstrate that patient satisfaction remained unchanged among clinics not receiving the One Key Question training intervention."
11386824|NCT03947788|EG000|Reported Event|Interventional Practices|"These clinics, including physicians, clinical and administrative staff, will receive the One Key Question training program, delivered by Power to Decide, via an in-person group training session.~OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care."
11386825|NCT03947788|EG001|Reported Event|Control Practices|These clinics will not receive the OKQ training program during the study period. They will have the opportunity to receive the training after the study period is over.
11386826|NCT03842436|BG000|Baseline|Digital Pills|"Digital Pills containing Truvada ingested once daily as PrEP~Digital pill: Digital pills over encapsulating Truvada~Truvada: Truvada prescribed with digital pills for PrEP"
11386827|NCT03842436|FG000|Participant Flow|Digital Pills|"Digital Pills containing Truvada ingested once daily as PrEP~Digital pill: Digital pills over encapsulating Truvada~Truvada: Truvada prescribed with digital pills for PrEP"
11386828|NCT03842436|OG000|Outcome|Digital Pills|"Digital Pills containing Truvada ingested once daily as PrEP~Digital pill: Digital pills over encapsulating Truvada~Truvada: Truvada prescribed with digital pills for PrEP"
11386829|NCT03842436|EG000|Reported Event|Digital Pills|"Digital Pills containing Truvada ingested once daily as PrEP~Digital pill: Digital pills over encapsulating Truvada~Truvada: Truvada prescribed with digital pills for PrEP"
11386830|NCT03646162|BG000|Baseline|Veru-944 10 mg|"Veru-944 10 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386831|NCT03646162|BG001|Baseline|Veru-944 50 mg|"Veru-944 50 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386832|NCT03646162|BG002|Baseline|Placebo|"Placebo daily~Placebo: Placebo"
11386833|NCT03646162|BG003|Baseline|Total|Total of all reporting groups
11386834|NCT03646162|FG000|Participant Flow|Veru-944 10 mg|"Veru-944 10 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386835|NCT03646162|FG001|Participant Flow|Veru-944 50 mg|"Veru-944 50 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386836|NCT03646162|FG002|Participant Flow|Placebo|"Placebo daily~Placebo: Placebo"
11386837|NCT03646162|OG000|Outcome|Veru-944 10 mg|"Veru-944 10 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386838|NCT03646162|OG001|Outcome|Veru-944 50 mg|"Veru-944 50 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386839|NCT03646162|OG002|Outcome|Placebo|"Placebo daily~Placebo: Placebo"
11386840|NCT03646162|OG000|Outcome|PK ≥195ng/mL|Subjects who had trough plasma concentrations ≥195 ng/mL at Day 84 change in moderate and severe hot flash frequency at Week 12,
11386841|NCT03646162|OG001|Outcome|PK <195 ng/mL|Subjects who had trough plasma concentrations <195 ng/mL at Day 84 change in moderate and severe hot flash frequency at Week 12,
11386842|NCT03646162|EG000|Reported Event|Veru-944 10 mg|"Veru-944 10 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386843|NCT03646162|EG001|Reported Event|Veru-944 50 mg|"Veru-944 50 mg daily~Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT"
11386844|NCT03646162|EG002|Reported Event|Placebo|"Placebo daily~Placebo: Placebo"
11386845|NCT03462030|BG000|Baseline|Baked Milk Immunotherapy|"Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Baked non-fat cow's milk powder: Oral immunotherapy with increasing quantities of baked milk."
11386846|NCT03462030|BG001|Baseline|Placebo|"Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Placebo: Tapioca Powder: Placebo control."
11386847|NCT03462030|BG002|Baseline|Total|Total of all reporting groups
11386848|NCT03462030|FG000|Participant Flow|Baked Milk Immunotherapy|"Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Baked non-fat cow's milk powder: Oral immunotherapy with increasing quantities of baked milk."
11386849|NCT03462030|FG001|Participant Flow|Placebo|"Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Placebo: Tapioca Powder: Placebo control."
11386850|NCT03462030|OG000|Outcome|Baked Milk Immunotherapy|"Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Baked non-fat cow's milk powder: Oral immunotherapy with increasing quantities of baked milk."
11386851|NCT03462030|OG001|Outcome|Placebo|"Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Placebo: Tapioca Powder: Placebo control."
11386852|NCT03462030|EG000|Reported Event|Baked Milk Immunotherapy|"Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Baked non-fat cow's milk powder: Oral immunotherapy with increasing quantities of baked milk."
11386853|NCT03462030|EG001|Reported Event|Placebo|"Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.~Placebo: Tapioca Powder: Placebo control."
11386854|NCT03446768|BG000|Baseline|Reactive Care (RC)|"Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support.~Peer support: Access to educational and informational support by a trained peer coach"
11386855|NCT03446768|BG001|Baseline|Proactive Care (PC)|"Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates.~Peer support: Access to educational and informational support by a trained peer coach~Online platform: An online platform that provides educational, informational and access to several therapeutic device metrics~Respiratory Therapist support: Limited medical support provided by trained Respiratory Therapists."
11386856|NCT03446768|BG002|Baseline|Total|Total of all reporting groups
11386857|NCT03446768|FG000|Participant Flow|Reactive Care (RC)|"Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support.~Peer support: Access to educational and informational support by a trained peer coach"
11338280|NCT03605693|EG000|Reported Event|Early Psychological Intervention|"Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner.~Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner."
11338281|NCT03605693|EG001|Reported Event|Usual Care|Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
10803580|NCT03417102|EG001|Reported Event|Fitusiran 80 mg Prophylaxis|Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months.
11338282|NCT03605745|BG000|Baseline|Treatment|"Prostatic Vapor Ablation with Rezum~Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."
11338283|NCT03605745|FG000|Participant Flow|Treatment|"Prostatic Vapor Ablation with Rezum~Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."
11338284|NCT03605745|OG000|Outcome|Treatment|"Prostatic Vapor Ablation with Rezum~Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."
11338285|NCT03605745|EG000|Reported Event|Treatment|"Prostatic Vapor Ablation with Rezum~Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."
11338286|NCT03605836|BG000|Baseline|Placebo: Single-blind Run-in Period Only|Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1) in the Single-blind Run-in Period only. Participants did not continue to Double-blind Treatment Period.
11338287|NCT03605836|BG001|Baseline|Double-blind Treatment Period: Placebo + Centanafadine SR 200 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338288|NCT03605836|BG002|Baseline|Double-blind Treatment Period: Placebo + Centanafadine SR 400 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
11338289|NCT03605836|BG003|Baseline|Double-blind Treatment Period: Placebo + Placebo|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338290|NCT03605836|BG004|Baseline|Total|Total of all reporting groups
11338291|NCT03605836|FG000|Participant Flow|Single-blind Run-in Period: Placebo|Placebo-matching tablets twice daily (BID) on Day -7 through Baseline (Day -1).
11338292|NCT03605836|FG001|Participant Flow|Double-blind Treatment Period: Centanafadine SR 200 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338293|NCT03605836|FG002|Participant Flow|Double-blind Treatment Period: Centanafadine SR 400 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target total daily dose (TDD) of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
11338294|NCT03605836|FG003|Participant Flow|Double-blind Treatment Period: Placebo|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine matching placebo SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11386858|NCT03446768|FG001|Participant Flow|Proactive Care (PC)|"Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates.~Peer support: Access to educational and informational support by a trained peer coach~Online platform: An online platform that provides educational, informational and access to several therapeutic device metrics~Respiratory Therapist support: Limited medical support provided by trained Respiratory Therapists."
11386859|NCT03446768|OG000|Outcome|Reactive Care (RC)|"Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support.~Peer support: Access to educational and informational support by a trained peer coach"
11386860|NCT03446768|OG001|Outcome|Proactive Care (PC)|"Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates.~Peer support: Access to educational and informational support by a trained peer coach~Online platform: An online platform that provides educational, informational and access to several therapeutic device metrics~Respiratory Therapist support: Limited medical support provided by trained Respiratory Therapists."
11386861|NCT03446768|EG000|Reported Event|Reactive Care (RC)|"Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support.~Peer support: Access to educational and informational support by a trained peer coach"
11386862|NCT03446768|EG001|Reported Event|Proactive Care (PC)|"Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates.~Peer support: Access to educational and informational support by a trained peer coach~Online platform: An online platform that provides educational, informational and access to several therapeutic device metrics~Respiratory Therapist support: Limited medical support provided by trained Respiratory Therapists."
11386863|NCT03348514|BG000|Baseline|CPX-POM - 30 mg/m^2|Period1, Dose Cohort - 30 mg/m^2
11386864|NCT03348514|BG001|Baseline|CPX-POM - 60 mg/m^2|Period 2, Dose Cohort - 60 mg/m^2
11386865|NCT03348514|BG002|Baseline|CPX-POM - 120 mg/m^2|Period 3, Dose Cohort - 120 mg/m^2
11386866|NCT03348514|BG003|Baseline|CPX-POM - 240 mg/m^2|Period 4, Dose Cohort - 240 mg/m^2
11386867|NCT03348514|BG004|Baseline|CPX-POM - 360 mg/m^2|Period 5, Dose Cohort - 360 mg/m^2
11386868|NCT03348514|BG005|Baseline|CPX-POM - 600 mg/m^2|Period 6, Dose Cohort - 600 mg/m^2
11386869|NCT03348514|BG006|Baseline|CPX-POM - 900 mg/m^2|Period 7, Dose Cohort - 900 mg/m^2
11386870|NCT03348514|BG007|Baseline|CPX-POM - 1200 mg/m^2|Period 8, Dose Cohort - 1200 mg/m^2
11386871|NCT03348514|BG008|Baseline|Total|Total of all reporting groups
11386872|NCT03348514|FG000|Participant Flow|CPX-POM - 30 mg/m^2|Period 1, Dose Cohort - 30 mg/m^2
11386873|NCT03348514|FG001|Participant Flow|CPX-POM - 60 mg/m^2|Period 2, Dose Cohort - 60 mg/m^2
11386874|NCT03348514|FG002|Participant Flow|CPX-POM - 120 mg/m^2|Period 3, Dose Cohort - 120 mg/m^2
11386875|NCT03348514|FG003|Participant Flow|CPX-POM - 240 mg/m^2|Period 4, Dose Cohort - 240 mg/m^2
11386876|NCT03348514|FG004|Participant Flow|CPX-POM - 360 mg/m^2|Period 5, Dose Cohort - 360 mg/m^2
11386877|NCT03348514|FG005|Participant Flow|CPX-POM - 600 mg/m^2|Period 6, Dose Cohort - 600 mg/m^2
11386878|NCT03348514|FG006|Participant Flow|CPX-POM - 900 mg/m^2|Period 7, Dose Cohort - 900 mg/m^2
11386879|NCT03348514|FG007|Participant Flow|CPX-POM - 1200 mg/m^2|Period 8, Dose Cohort - 1200 mg/m^2
11386880|NCT03348514|OG000|Outcome|CPX-POM - 30 mg/m^2|Period 1, Dose Cohort - 30 mg/m^2
11386881|NCT03348514|OG001|Outcome|CPX-POM - 60 mg/m^2|Period 2, Dose Cohort - 60 mg/m^2
11386882|NCT03348514|OG002|Outcome|CPX-POM - 120 mg/m^2|Period 3, Dose Cohort - 120 mg/m^2
11386883|NCT03348514|OG003|Outcome|CPX-POM - 240 mg/m^2|Period 4, Dose Cohort - 240 mg/m^2
11386884|NCT03348514|OG004|Outcome|CPX-POM - 360 mg/m^2|Period 5, Dose Cohort - 360 mg/m^2
11386885|NCT03348514|OG005|Outcome|CPX-POM - 600 mg/m^2|Period 6, Dose Cohort - 600 mg/m^2
11386886|NCT03348514|OG006|Outcome|CPX-POM - 900 mg/m^2|Period 7, Dose Cohort - 900 mg/m^2
11386887|NCT03348514|OG007|Outcome|CPX-POM - 1200 mg/m^2|Period 8, Dose Cohort - 1200 mg/m^2
11386888|NCT03348514|OG000|Outcome|All Participants|All participants who received at least one dose of CPX-POM either at 30 mg/m^2, 60 mg/m^2, 120 mg/m^2, 240 mg/m^2, 360 mg/m^2, 600 mg/m^2, 900 mg/m^2 and 1200 mg/m^2 via IV.
11386889|NCT03348514|OG002|Outcome|CPX-POM - 120 mg/m^2|Period 3, Cohort Dose - 120 mg/m^2
11386890|NCT03348514|OG003|Outcome|CPX-POM - 240 mg/m^2|Period 4, Cohort Dose - 240 mg/m^2
11386891|NCT03348514|EG000|Reported Event|CPX-POM - 30 mg/m^2|Period 1, Dose Cohort - 30 mg/m^2
11386892|NCT03348514|EG001|Reported Event|CPX-POM - 60 mg/m^2|Period 2, Dose Cohort - 60 mg/m^2
11386893|NCT03348514|EG002|Reported Event|CPX-POM - 120 mg/m^2|Period 3, Dose Cohort - 120 mg/m^2
11386894|NCT03348514|EG003|Reported Event|CPX-POM - 240 mg/m^2|Period 4, Dose Cohort - 240 mg/m^2
11386895|NCT03348514|EG004|Reported Event|CPX-POM - 360 mg/m^2|Period 5, Dose Cohort - 360 mg/m^2
11386896|NCT03348514|EG005|Reported Event|CPX-POM - 600 mg/m^2|Period 6, Dose Cohort - 600 mg/m^2
11386897|NCT03348514|EG006|Reported Event|CPX-POM - 900 mg/m^2|Period 7 Dose Cohort - 900 mg/m^2
11386898|NCT03348514|EG007|Reported Event|CPX-POM - 1200 mg/m^2|Period 8, Dose Cohort - 1200 mg/m^2
11197211|NCT02169869|BG000|Baseline|Immediate Postplacental IUD Insertion|"Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11197212|NCT02169869|BG001|Baseline|6 Weeks Postpartum IUD Insertion|"Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11197213|NCT02169869|BG002|Baseline|Total|Total of all reporting groups
11338295|NCT03605836|OG000|Outcome|Double-blind Treatment Period: Centanafadine SR 200 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338296|NCT03605836|OG001|Outcome|Double-blind Treatment Period: Centanafadine SR 400 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
11338297|NCT03605836|OG002|Outcome|Double-blind Treatment Period: Placebo|Following Single-blind Run-in Period, participants with <30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine matching placebo SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338298|NCT03605836|EG000|Reported Event|Placebo: Single-blind Run-in Period Only|Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1) in the Single-blind Run-in Period only. Participants did not continue to Double-blind Treatment Period.
11338299|NCT03605836|EG001|Reported Event|Placebo + Centanafadine SR 200 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338300|NCT03605836|EG002|Reported Event|Placebo + Centanafadine SR 400 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
11338301|NCT03605836|EG003|Reported Event|Placebo + Placebo|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
11338302|NCT03605914|BG000|Baseline|NSAID|"The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.~diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac."
11338303|NCT03605914|BG001|Baseline|Opioid|"The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).~Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen)."
11338304|NCT03605914|BG002|Baseline|Total|Total of all reporting groups
11338305|NCT03605914|FG000|Participant Flow|NSAID|"The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.~diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac."
11338306|NCT03605914|FG001|Participant Flow|Opioid|"The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).~Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen)."
11338307|NCT03605914|OG000|Outcome|NSAID|"The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.~diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac."
11338308|NCT03605914|OG001|Outcome|Opioid|"The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).~Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen)."
11338309|NCT03605914|EG000|Reported Event|NSAID|"The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.~diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac."
11386899|NCT03253393|BG000|Baseline|SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch|Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.
11386900|NCT03253393|BG001|Baseline|H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch|Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.
11386901|NCT03253393|BG002|Baseline|SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch|Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.
11386902|NCT03253393|BG003|Baseline|Total|Total of all reporting groups
11386903|NCT03253393|FG000|Participant Flow|SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch|"Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.~Smart Touch Technology packaging: midafilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel, with EDTA)~Conventional lens packaging: hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)"
11386904|NCT03253393|FG001|Participant Flow|H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch|Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.
11386905|NCT03253393|FG002|Participant Flow|SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch|Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.
11386906|NCT03253393|OG000|Outcome|Silicone Hydrogel (With EDTA) in Smart Touch|Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).
11386907|NCT03253393|OG001|Outcome|Silicone Hydrogel (With EDTA) in Conventional Packaging|Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging
11386908|NCT03253393|OG002|Outcome|Silicone Hydrogel (no EDTA) in Smart Touch|Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).
11386909|NCT03253393|OG003|Outcome|Hydrogel (no EDTA) in Smart Touch|Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).
11386910|NCT03253393|OG004|Outcome|Hydrogel (no EDTA) in Conventional Packaging|Lens Contamination for Hydrogel in Conventional packaging (no EDTA).
11386911|NCT03253393|OG005|Outcome|Hydrogel (With EDTA) in Smart Touch|Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).
11386912|NCT03253393|EG000|Reported Event|Silicone Hydrogel (With EDTA) in Smart Touch|Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).
11386913|NCT03253393|EG001|Reported Event|Silicone Hydrogel (With EDTA) in Conventional Packaging|Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging
11386914|NCT03253393|EG002|Reported Event|Silicone Hydrogel (no EDTA) in Smart Touch|Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).
11386915|NCT03253393|EG003|Reported Event|Hydrogel (no EDTA) in Smart Touch|Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).
11386916|NCT03253393|EG004|Reported Event|Hydrogel (no EDTA) in Conventional Packaging|Lens Contamination for Hydrogel in Conventional packaging (no EDTA).
11386917|NCT03253393|EG005|Reported Event|Hydrogel (With EDTA) in Smart Touch|Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).
11386918|NCT03188822|BG000|Baseline|Bioabsorbable Steroid Releasing Sinus Implant|"Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid~Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days."
11386919|NCT03188822|FG000|Participant Flow|Bioabsorbable Steroid Releasing Sinus Implant|"Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid~Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days."
11386920|NCT03188822|OG000|Outcome|Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid|"Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid~Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.~Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days."
11386921|NCT03188822|EG000|Reported Event|Bioabsorbable Steroid Releasing Sinus Implant|"Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid~Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days."
11386922|NCT03128671|BG000|Baseline|FAVoR Intervention Group|"In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.~FAVoR Intervention: The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family."
11386923|NCT03128671|BG001|Baseline|Control Group|The control group will not receive the FAVoR intervention. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.
11386924|NCT03128671|BG002|Baseline|Total|Total of all reporting groups
11386925|NCT03128671|FG000|Participant Flow|FAVoR Intervention Group|"In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.~FAVoR Intervention: The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family."
11386926|NCT03128671|FG001|Participant Flow|Control Group|The control group will not receive the FAVoR intervention. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.
11386927|NCT03128671|OG000|Outcome|FAVoR Intervention Group|"In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.~FAVoR Intervention: The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family."
11386928|NCT03128671|OG001|Outcome|Control Group|The control group will not receive the FAVoR intervention. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.
10800094|NCT02614261|FG001|Participant Flow|Galcanezumab 120mg|"Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
10800095|NCT02614261|FG002|Participant Flow|Galcanezumab 240mg|"Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.~Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.~Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered."
11197214|NCT02169869|FG000|Participant Flow|Immediate Postplacental IUD Insertion|"Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11338310|NCT03605914|EG001|Reported Event|Opioid|"The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).~Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen)."
11338311|NCT03606187|BG000|Baseline|Test Arm|"Subjects randomized to this arm will receive test treatment~Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system"
11338312|NCT03606187|BG001|Baseline|Control Arm|"Subjects randomized to this arm will receive control treatment~Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system"
11338313|NCT03606187|BG002|Baseline|Total|Total of all reporting groups
11338314|NCT03606187|FG000|Participant Flow|Test Arm|"Subjects randomized to this arm will receive test treatment~Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system"
11338315|NCT03606187|FG001|Participant Flow|Control Arm|"Subjects randomized to this arm will receive control treatment~Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system"
11338316|NCT03606187|OG000|Outcome|Test Arm|"Subjects randomized to this arm will receive test treatment~Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system"
11338317|NCT03606187|OG001|Outcome|Control Arm|"Subjects randomized to this arm will receive test treatment~Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system"
11338318|NCT03606187|EG000|Reported Event|Test Arm|"Subjects randomized to this arm will receive test treatment~Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system"
11338319|NCT03606187|EG001|Reported Event|Control Arm|"Subjects randomized to this arm will receive test treatment~Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system"
11338320|NCT03606343|BG000|Baseline|Open Trial|"Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens~Teaching Academic Skills to Kids: Group treatment"
11338321|NCT03606343|FG000|Participant Flow|Open Trial|"Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens~Teaching Academic Skills to Kids: Group treatment"
11338322|NCT03606343|OG000|Outcome|Open Trial|"Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens~Teaching Academic Skills to Kids: Group treatment"
11338323|NCT03606343|EG000|Reported Event|Open Trial|"Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens~Teaching Academic Skills to Kids: Group treatment"
11338324|NCT03606460|BG000|Baseline|Cohort 1|This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion.
11338325|NCT03606460|BG001|Baseline|Cohort 2|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
11338326|NCT03606460|BG002|Baseline|Total|Total of all reporting groups
11338327|NCT03606460|FG000|Participant Flow|Cohort 1|This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion.
10800096|NCT02614261|FG003|Participant Flow|Israel Addendum|Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
10800097|NCT02614261|OG000|Outcome|Placebo|Participants received placebo once a month by subcutaneous injection for 3 months.
10800098|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
10800099|NCT02614261|OG002|Outcome|Galcanezumab 240mg|Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
10800100|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg of galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
10800101|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
10800102|NCT02614261|OG002|Outcome|Galcanezumab 240mg|Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
10800103|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
10800104|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240 mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
11386929|NCT03128671|EG000|Reported Event|FAVoR Intervention Group|"In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.~FAVoR Intervention: The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family."
11386930|NCT03128671|EG001|Reported Event|Control Group|The control group will not receive the FAVoR intervention. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.
10800105|NCT02614261|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month by subcutaneous injection for 2 months.
10800106|NCT02614261|OG000|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
10800107|NCT02614261|OG001|Outcome|Galcanezumab 240mg|Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
10800108|NCT02614261|EG000|Reported Event|Placebo - Double-Blind Treatment Phase|Participants received placebo once a month by subcutaneous injection for 3 months.
10800109|NCT02614261|EG001|Reported Event|Galcanezumab 120mg - Double-Blind Treatment Phase|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
10800110|NCT02614261|EG002|Reported Event|Galcanezumab 240mg - Double-Blind Treatment Phase|Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
10800111|NCT02614261|EG003|Reported Event|Placebo/Galcanezumab - Open-Label Extension Phase|After completion of Placebo double-blind phase, participants had an option to enter open-label extension phase where they received 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
10800112|NCT02614261|EG004|Reported Event|Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase|After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
10800113|NCT02614261|EG005|Reported Event|Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase|After completion of Galcanezumab 240mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
10800114|NCT02614261|EG006|Reported Event|Placebo - Follow-up Phase|Participants entered follow-up phase from placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
10800115|NCT02614261|EG007|Reported Event|Galcanezumab 120mg - Follow-up Phase|Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
10800116|NCT02614261|EG008|Reported Event|Galcanezumab 240mg - Follow-up Phase|Participants entered follow-up phase from from Galcanezumab 240mg double-blind treatment phase and were observed for 4 months. No treatments administered.
10800117|NCT02614261|EG009|Reported Event|Placebo/Galcanezumab - Follow-up Phase|Participants entered follow-up phase from Placebo/Galcanezumabopen-label extension phase and were observed for 4 months. No treatments administered.
10800118|NCT02614261|EG010|Reported Event|Galcanezumab 120mg/Galcanezumab - Follow-up Phase|Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
10800119|NCT02614261|EG011|Reported Event|Galcanezumab 240mg/Galcanezumab - Follow-up Phase|Participants entered follow-up phase from Galcanezumab 240mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
11386931|NCT03111732|BG000|Baseline|1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine|"Pembrolizumab plus Oxaliplatin plus Capecitabine~Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle~Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6~Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6"
11386932|NCT03111732|FG000|Participant Flow|1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine|"Pembrolizumab plus Oxaliplatin plus Capecitabine~Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle~Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6~Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6"
11386933|NCT03111732|OG000|Outcome|1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine|"Pembrolizumab plus Oxaliplatin plus Capecitabine~Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle~Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6~Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6"
11386934|NCT03111732|OG000|Outcome|Unrelated|Unrelated to drug.
11386935|NCT03111732|OG001|Outcome|Unlikely|Unlikely related to drug.
11386936|NCT03111732|OG002|Outcome|Possibly|Possibly related to drug.
11386937|NCT03111732|OG003|Outcome|Probably|Probably related to drug.
11386938|NCT03111732|OG004|Outcome|Definitely|Definitely related to drug.
11386939|NCT03111732|EG000|Reported Event|1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine|"Pembrolizumab plus Oxaliplatin plus Capecitabine~Pembrolizumab (MK-3475): 200 mg will be administered as an intravenous (IV) infusion on Day 1 of each 21 day cycle~Oxaliplatin: 130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6~Capecitabine: 750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6"
11386940|NCT03065244|BG000|Baseline|IVIG|"Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion~IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours"
11386941|NCT03065244|BG001|Baseline|Infliximab|"Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours~Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours"
11386942|NCT03065244|BG002|Baseline|Total|Total of all reporting groups
11386943|NCT03065244|FG000|Participant Flow|IVIG|"Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion~IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours"
11386944|NCT03065244|FG001|Participant Flow|Infliximab|"Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours~Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours"
10800120|NCT02614261|EG012|Reported Event|Israel Addendum|Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
11386945|NCT03065244|OG000|Outcome|IVIG|"Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion~IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours"
11386946|NCT03065244|OG001|Outcome|Infliximab|"Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours~Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours"
11386947|NCT03065244|EG000|Reported Event|IVIG|"Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion~IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours"
11386948|NCT03065244|EG001|Reported Event|Infliximab|"Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours~Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours"
11386949|NCT02879305|BG000|Baseline|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received daprodustat tablets at dose levels of 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily until the required number of major adverse cardiovascular event (MACE) occurred, at approximately 45.1 months of randomized treatment. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]).
11386950|NCT02879305|BG001|Baseline|rhEPO|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received treatment with rhEPO. Participants on hemodialysis received epoetin alfa as intravenous (IV) injection once weekly or three-times weekly with total weekly dose levels ranging from 1500 to 60,000 Units. Participants on peritoneal dialysis received subcutaneous (SC) injection of darbepoetin alfa every 1, 2, or 4 weeks with 4-weekly total dose levels ranging from 20 to 400 microgram (mcg). Darbepoetin could be given by IV injection for peritoneal dialysis participants switching to hemodialysis. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL) and administered until the required number of MACE events occurred, at approximately 45.1 months of randomized treatment.
11386951|NCT02879305|BG002|Baseline|Total|Total of all reporting groups
11386952|NCT02879305|FG000|Participant Flow|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received daprodustat tablets at dose levels of 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily until the required number of major adverse cardiovascular event (MACE) occurred, at approximately 45.1 months of randomized treatment. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]).
11386953|NCT02879305|FG001|Participant Flow|rhEPO|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received treatment with rhEPO. Participants on hemodialysis received epoetin alfa as intravenous (IV) injection once weekly or three-times weekly with total weekly dose levels ranging from 1500 to 60,000 Units. Participants on peritoneal dialysis received subcutaneous (SC) injection of darbepoetin alfa every 1, 2, or 4 weeks with 4-weekly total dose levels ranging from 20 to 400 microgram (mcg). Darbepoetin could be given by IV injection for peritoneal dialysis participants switching to hemodialysis. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL) and administered until the required number of MACE events occurred, at approximately 45.1 months of randomized treatment.
11386954|NCT02879305|OG000|Outcome|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received daprodustat tablets at dose levels of 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily until the required number of major adverse cardiovascular event (MACE) occurred, at approximately 45.1 months of randomized treatment. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]).
11386955|NCT02879305|OG001|Outcome|rhEPO|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received treatment with rhEPO. Participants on hemodialysis received epoetin alfa as intravenous (IV) injection once weekly or three-times weekly with total weekly dose levels ranging from 1500 to 60,000 Units. Participants on peritoneal dialysis received subcutaneous (SC) injection of darbepoetin alfa every 1, 2, or 4 weeks with 4-weekly total dose levels ranging from 20 to 400 microgram (mcg). Darbepoetin could be given by IV injection for peritoneal dialysis participants switching to hemodialysis. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL) and administered until the required number of MACE events occurred, at approximately 45.1 months of randomized treatment.
11386956|NCT02879305|EG000|Reported Event|Daprodustat|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received daprodustat tablets at dose levels of 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily until the required number of major adverse cardiovascular event (MACE) occurred, at approximately 45.1 months of randomized treatment. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]).
11386957|NCT02879305|EG001|Reported Event|rhEPO|Participants received placebo tablets orally once daily in run-in period from Week -4 up to randomization (Day 1) and subsequently received treatment with rhEPO. Participants on hemodialysis received epoetin alfa as intravenous (IV) injection once weekly or three-times weekly with total weekly dose levels ranging from 1500 to 60,000 Units. Participants on peritoneal dialysis received subcutaneous (SC) injection of darbepoetin alfa every 1, 2, or 4 weeks with 4-weekly total dose levels ranging from 20 to 400 microgram (mcg). Darbepoetin could be given by IV injection for peritoneal dialysis participants switching to hemodialysis. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL) and administered until the required number of MACE events occurred, at approximately 45.1 months of randomized treatment.
11386958|NCT02816736|BG000|Baseline|LCZ696 (Entresto) + Placebo|"LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks~LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.~valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)"
11197215|NCT02169869|FG001|Participant Flow|6 Weeks Postpartum IUD Insertion|"Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11197216|NCT02169869|OG000|Outcome|Immediate Postplacental IUD Insertion|"Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11197217|NCT02169869|OG001|Outcome|6 Weeks Postpartum IUD Insertion|"Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11386959|NCT02816736|BG001|Baseline|Valsartan + Placebo|"valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks~valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).~LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)"
11386960|NCT02816736|BG002|Baseline|Total|Total of all reporting groups
11386961|NCT02816736|FG000|Participant Flow|LCZ696 (Entresto) + Placebo|"LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks~LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.~valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)"
10800121|NCT02527434|BG000|Baseline|UBC Cohort|"Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
10800122|NCT02527434|BG001|Baseline|TNBC Cohort|"Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
10803926|NCT01049035|FG004|Participant Flow|Group 5: MenACYW Conjugate Vaccine: 12 Months|Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
11197218|NCT02169869|EG000|Reported Event|Immediate Postplacental IUD Insertion|"Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11386962|NCT02816736|FG001|Participant Flow|Valsartan + Placebo|"valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks~valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).~LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)"
11386963|NCT02816736|OG000|Outcome|LCZ696 (Entresto) + Placebo|"LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks~LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.~valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)"
11386964|NCT02816736|OG001|Outcome|Valsartan + Placebo|"valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks~valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).~LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)"
11386965|NCT02816736|EG000|Reported Event|LCZ696 (Entresto) + Placebo|"LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks~LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.~valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)"
11386966|NCT02816736|EG001|Reported Event|Valsartan + Placebo|"valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks~valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).~LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)"
11386967|NCT02787850|BG000|Baseline|CoolSculpting Treatment Cohort A|"The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts.~The CoolSculpting device will be used to perform treatments."
11386968|NCT02787850|BG001|Baseline|CoolSculpting Treatment Cohort B|"The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts.~The CoolSculpting device will be used to perform treatments."
11386969|NCT02787850|BG002|Baseline|Total|Total of all reporting groups
11386970|NCT02787850|FG000|Participant Flow|CoolSculpting Treatment Cohort A|CoolSculpting device with and without Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort A will receive treatments on one side of the abdomen without the Crown Cooling Insert with a protocol-defined temperature for 60 minutes. The contralateral side of the abdomen will be treated with the Crown Cooling Insert using a protocol-defined temperature for 45 minutes.
11241360|NCT02486406|EG004|Reported Event|Mini Tablet, 3-8 yr, Part 1|Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
10803927|NCT01049035|FG005|Participant Flow|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11241361|NCT02486406|EG005|Reported Event|Mini Tablet, Total|Participants who received at least one dose of the mini-tablet formulation
11197219|NCT02169869|EG001|Reported Event|6 Weeks Postpartum IUD Insertion|"Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.~Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.~Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes."
11197220|NCT02169895|BG000|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25"
11197221|NCT02169895|BG001|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
11197222|NCT02169895|BG002|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
11197223|NCT02169895|BG003|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
11197224|NCT02169895|BG004|Baseline|Total|Total of all reporting groups
11197225|NCT02169895|FG000|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
11386971|NCT02787850|FG001|Participant Flow|CoolSculpting Treatment Cohort B|CoolSculpting device with the Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort B subjects will be treated one one half of the abdomen with the Crown Cooling Insert at a protocol-defined temperature for 45 minutes. The contralateral side of the abdomen will also be treated with the Cron Cooling Insert at a protocol-defined temperature for 60 minutes.
11386972|NCT02787850|OG000|Outcome|Overall Study Population-Both Cohorts|The analysis population included subjects enrolled in both cohorts of the study.
11386973|NCT02787850|OG001|Outcome|Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature|The abdomen was treated for a duration of 60 minutes per a protocol-defined temperature using the CCI applicator accessory.
11386974|NCT02787850|OG002|Outcome|Abdomen Sites Treated With CCI for 45 Minutes|1 side of the abdomen was treated for 45 minutes at a protocol defined temperature with the CCI applicator accessory.
11386975|NCT02787850|OG003|Outcome|Abdomen Site Treated for 60 Minutes|One abdomen site was treated with a lower protocol-defined temperature for 60 minutes with the CCI accessory.
11197226|NCT02169895|FG001|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
11197227|NCT02169895|FG002|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
11197228|NCT02169895|FG003|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
11197229|NCT02169895|OG000|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11197230|NCT02169895|OG001|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11197231|NCT02169895|OG002|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11197232|NCT02169895|OG003|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
11386976|NCT02787850|OG000|Outcome|Cohort A|One side of the abdomen was treated using the CoolMax applicator and the Crown Cooling Insert for 60 minutes at a protocol-defined temperature. The contralateral side of the abdomen was treated was treated using the CoolMax applicator and Crown Cooling Insert for 45 minutes at a protocol-defined temperature.
11386977|NCT02787850|OG001|Outcome|Cohort B|One side of the abdomen was treated with the CoolMax applicator and Crown Cooling Insert for 45 minutes at a protocol-defined temperature; the contralateral side of the abdomen was treated with the CoolMax applicator and the Crown Cooling Insert for 60 minutes at a protocol-defined temperature.
11386978|NCT02787850|OG000|Outcome|Subgroup 1 Treatment Parameters|Abdomen areas treated with CoolSculpting without the Crown Cooling Inser for 60 minutes.
11386979|NCT02787850|OG001|Outcome|Subgroup 2 Treatment Parameters|Abdomen areas treated with CoolSculpting with the Crown Cooling Insert for 45 minutes at a protocol defined temperature
11386980|NCT02787850|OG002|Outcome|Subgroup 3 Treatment Parameters|Abdomen areas treated with CoolSculpting and the Crown Cooling insert for 60 minutes at a protocol-defined temperature
11386981|NCT02787850|EG000|Reported Event|Cohort A-Abdomen Side 1|Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes without the Crown Cooling Insert.
11386982|NCT02787850|EG001|Reported Event|Cohort A-Abdomen Side 2|Abdomen side 2 will be treated using the CoolMax applicator and the Crown Cooling Insert for 45 minutes at a protocol-defined temperature.
11386983|NCT02787850|EG002|Reported Event|Cohort B-Abdomen Side 1|Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes with the CoolMax Applicator and Crown Cooling Insert.
11386984|NCT02787850|EG003|Reported Event|Cohort B- Abdomen Side 2|Abdomen side 2 will be treated with the CoolMAx applicator at a second protocol-defined temperature for 60 minutes, with the Crown Cooling Insert.
11386985|NCT02713373|BG000|Baseline|Arm I (Cetuximab and Pembrolizumab)|"Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11386986|NCT02713373|FG000|Participant Flow|Arm I (Cetuximab and Pembrolizumab)|"Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11386987|NCT02713373|OG000|Outcome|Arm I (Cetuximab and Pembrolizumab)|"Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11386988|NCT02713373|EG000|Reported Event|Arm I (Cetuximab and Pembrolizumab)|"Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11386989|NCT02676284|BG000|Baseline|DUROLANE SJ|Sodium hyaluronate, 20 mg/mL, single injection
11386990|NCT02676284|FG000|Participant Flow|DUROLANE SJ|Sodium hyaluronate, 20 mg/mL, single injection
11386991|NCT02676284|OG000|Outcome|DUROLANE SJ|Sodium hyaluronate, 20 mg/mL, single injection
11386992|NCT02676284|EG000|Reported Event|DUROLANE SJ|Sodium hyaluronate, 20 mg/mL, single injection
11386993|NCT02431702|BG000|Baseline|Part 1-Oral Antipsychotics (OAP)|All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator.
11386994|NCT02431702|FG000|Participant Flow|Part 1-Run-in: Oral Antipsychotics (OAP)|All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator.
11386995|NCT02431702|FG001|Participant Flow|Part 2-Paliperidone Palmitate (PP)|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months.
11386996|NCT02431702|FG002|Participant Flow|Part 2-OAP|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
11386997|NCT02431702|FG003|Participant Flow|Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification)|Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
11386998|NCT02431702|FG004|Participant Flow|Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification)|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M or PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
10803587|NCT03278626|BG000|Baseline|Nivolimumab+Carboplatin/Paclitaxel+Radiation|"240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation~Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64))."
11386999|NCT02431702|FG005|Participant Flow|Part 3-OAP to OAP (EDP and Disease Modification)|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
11387000|NCT02431702|FG006|Participant Flow|Healthy Controls|Participants did not receive any study medication and did not fall into any of the 3 parts of the study. For reporting purposes, the completion of the Healthy Controls were entered in Part 1 and not in the other parts.
11387001|NCT02431702|OG000|Outcome|Part-2: Paliperidone Palmitate (PP)|Participants who completed part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
11387002|NCT02431702|OG001|Outcome|Part-2: OAP|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
11387003|NCT02431702|OG000|Outcome|Part 3-PP to PP|Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
11387004|NCT02431702|OG001|Outcome|Part 3-OAP to OAP|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
11387005|NCT02431702|OG000|Outcome|Part 3- PP to PP|Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
11387006|NCT02431702|OG001|Outcome|Part 3- OAP to PP (or Delayed-Start PP)|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M and PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
11387007|NCT02431702|OG002|Outcome|Part 3-OAP to OAP|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
11387008|NCT02431702|OG000|Outcome|Part-2: Paliperidone Palmitate (PP)|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
11387009|NCT02431702|EG000|Reported Event|Part 1-Run-in: Oral Antipsychotics (OAP)|All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator.
11387010|NCT02431702|EG001|Reported Event|Part 2-Paliperidone Palmitate (PP)|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months.
11197233|NCT02169895|EG000|Reported Event|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11387011|NCT02431702|EG002|Reported Event|Part 2-OAP|Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
11387012|NCT02431702|EG003|Reported Event|Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification)|Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
11387013|NCT02431702|EG004|Reported Event|Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification)|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M or PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
11387014|NCT02431702|EG005|Reported Event|Part 3-OAP to OAP (EDP and Disease Modification)|Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
11197234|NCT02169895|EG001|Reported Event|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11197235|NCT02169895|EG002|Reported Event|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
11387015|NCT02368002|BG000|Baseline|Week 3 Treatment Response Assessment|Participants randomized to have their weight assessed at their 3rd session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment.
11387016|NCT02368002|BG001|Baseline|Week 7 Treatment Response Assessment|Participants randomized to have their weight assessed at their 7th session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment.
11387017|NCT02368002|BG002|Baseline|Portion Controlled Meals|Portion controlled meals: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to continue with behavioral weight loss therapy that is augmented with portion controlled meals (PCM).
11387018|NCT02368002|BG003|Baseline|Acceptance-based Treatment|Acceptance-based treatment: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to switching the therapeutic approach to an acceptance-based treatment.
11387019|NCT02368002|BG004|Baseline|Total|Total of all reporting groups
11387020|NCT02368002|FG000|Participant Flow|Session 3 Treatment Response Assessment|Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
11387021|NCT02368002|FG001|Participant Flow|Session 3 Treatment Response Assessment & ABT|Participants randomized to treatment response assessment at session 3 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to switch to ABT.
11197236|NCT02169895|EG003|Reported Event|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
11387022|NCT02368002|FG002|Participant Flow|Session 3 Treatment Response Assessment & PCM|Participants randomized to treatment response assessment at session 3 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM.
11387023|NCT02368002|FG003|Participant Flow|Session 7 Treatment Response Assessment|Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
11387024|NCT02368002|FG004|Participant Flow|Session 7 Treatment Response Assessment & ABT|Participants randomized to treatment response assessment at session 7 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to switch to ABT.
11387025|NCT02368002|FG005|Participant Flow|Session 7 Treatment Response Assessment & PCM|Participants randomized to treatment response assessment at session 7 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM.
11387026|NCT02368002|OG000|Outcome|Portion-controlled Meals|Portion-controlled meals: Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM).
11387027|NCT02368002|OG001|Outcome|Acceptance-based Treatment|Acceptance-based treatment: Participants switch to treatment teaching acceptance-based behavioral skills.
11387028|NCT02368002|OG000|Outcome|3 Week Treatment Response Assessment (Early TRA)|Participants all began by receiving Standard Behavioral Weight Loss Treatment (SBT) sessions. Participants were randomized to treatment response assessment (TRA) at Week 3.
11387029|NCT02368002|OG001|Outcome|7 Week Treatment Response Assessment (Late TRA)|Participants all began by receiving Standard Behavioral Weight Loss Treatment (SBT) sessions. Participants were randomized to treatment response assessment (TRA) at Week 7.
11387030|NCT02368002|EG000|Reported Event|Week 3 Treatment Response Assessment|Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
11387031|NCT02368002|EG001|Reported Event|Week 7 Treatment Response Assessment|Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs.
11387032|NCT02368002|EG002|Reported Event|Portion Controlled Meals|Portion controlled meals: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to portion controlled meals.
11387033|NCT02368002|EG003|Reported Event|Acceptance-based Treatment|Acceptance-based treatment: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to acceptance-based treatment.
11387034|NCT02200770|BG000|Baseline|Placebo/Inebilizumab|Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387035|NCT02200770|BG001|Baseline|Inebilizumab/Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387036|NCT02200770|BG002|Baseline|Total|Total of all reporting groups
11387037|NCT02200770|FG000|Participant Flow|Placebo/Inebilizumab|Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
10803588|NCT03278626|FG000|Participant Flow|Nivolimumab+Carboplatin/Paclitaxel+Radiation|"240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation~Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64))."
10965819|NCT00884117|OG002|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965820|NCT00884117|OG000|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965821|NCT00884117|EG000|Reported Event|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
11197237|NCT02170025|BG000|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
11197238|NCT02170025|BG001|Baseline|Placebo|Participants received matching placebo tid
11387038|NCT02200770|FG001|Participant Flow|Inebilizumab/Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387039|NCT02200770|OG000|Outcome|Placebo/Inebilizumab|Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387040|NCT02200770|OG001|Outcome|Inebilizumab/Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387041|NCT02200770|OG000|Outcome|Any Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 in RCP or IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP ; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
10965822|NCT00884117|EG001|Reported Event|Participants Not Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
10965823|NCT00884221|BG000|Baseline|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
11197239|NCT02170025|BG002|Baseline|Total|Total of all reporting groups
11197240|NCT02170025|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
11197241|NCT02170025|FG001|Participant Flow|Placebo|Participants received matching placebo tid
11241362|NCT02486406|EG006|Reported Event|All Participants, Total|All participants who received at least one dose of study drug in Part 1 or Part 2
11387042|NCT02200770|OG000|Outcome|Inebilizumab/Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387043|NCT02200770|EG000|Reported Event|Placebo/Inebilizumab|Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387044|NCT02200770|EG001|Reported Event|Inebilizumab/Inebilizumab|AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
11387045|NCT02136069|BG000|Baseline|Etrolizumab + Placebo (IV)|Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
11387046|NCT02136069|BG001|Baseline|Infliximab + Placebo (Injection)|Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
11387047|NCT02136069|BG002|Baseline|Total|Total of all reporting groups
11387048|NCT02136069|FG000|Participant Flow|Etrolizumab + Placebo (IV)|Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
11387049|NCT02136069|FG001|Participant Flow|Infliximab + Placebo (Injection)|Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
11387050|NCT02136069|OG000|Outcome|Etrolizumab + Placebo (IV)|Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
11387051|NCT02136069|OG001|Outcome|Infliximab + Placebo (Injection)|Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
11387052|NCT02136069|EG000|Reported Event|Etrolizumab + Placebo (IV)|Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
11387053|NCT02136069|EG001|Reported Event|Infliximab + Placebo (Injection)|Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
11387054|NCT02086552|BG000|Baseline|Treatment (Sonidegib, Lenalidomide)|Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11387055|NCT02086552|FG000|Participant Flow|Treatment (Sonidegib, Lenalidomide)|Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11387056|NCT02086552|OG000|Outcome|Treatment (Sonidegib, Lenalidomide)|Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11387057|NCT02086552|EG000|Reported Event|Treatment (Sonidegib, Lenalidomide)|Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
11387058|NCT01517659|BG000|Baseline|Fat Reduction in Inner Thighs|The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11387059|NCT01517659|FG000|Participant Flow|Fat Reduction in Inner Thighs|The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11387060|NCT01517659|OG000|Outcome|Fat Reduction in Inner Thighs|The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11387061|NCT01517659|OG000|Outcome|Inner Thigh Treated With CoolSculpting|The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11387062|NCT01517659|EG000|Reported Event|Fat Reduction in Inner Thighs|The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
11387063|NCT01209767|BG000|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
11197242|NCT02170025|OG000|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
11387064|NCT01209767|FG000|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
11387065|NCT01209767|OG000|Outcome|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
11387066|NCT01209767|OG001|Outcome|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
11387067|NCT01209767|OG002|Outcome|Control|Area that received no treatment
11387068|NCT01209767|EG000|Reported Event|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
11387069|NCT01209767|EG001|Reported Event|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
11387070|NCT01209767|EG002|Reported Event|Control|Nothing was done to the area.
11387071|NCT01186848|BG000|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
11387072|NCT01186848|FG000|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
11387073|NCT01186848|OG000|Outcome|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
11387074|NCT01186848|OG001|Outcome|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
11387075|NCT01186848|EG000|Reported Event|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
11387076|NCT01186848|EG001|Reported Event|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
11387077|NCT01040624|BG000|Baseline|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387078|NCT01040624|BG001|Baseline|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387079|NCT01040624|BG002|Baseline|Total|Total of all reporting groups
11387080|NCT01040624|FG000|Participant Flow|HR-A|"< 15% risk of + lymph nodes (LN)~< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months."
11387081|NCT01040624|FG001|Participant Flow|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387082|NCT01040624|OG000|Outcome|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387083|NCT01040624|OG001|Outcome|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387084|NCT01040624|EG000|Reported Event|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
11387085|NCT01040624|EG001|Reported Event|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
10803928|NCT01049035|FG006|Participant Flow|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11197243|NCT02170025|OG001|Outcome|Placebo|Participants received matching placebo tid
11197244|NCT02170025|EG000|Reported Event|Placebo|Participants received matching placebo tid
11387086|NCT01024608|BG000|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387087|NCT01024608|BG001|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387088|NCT01024608|BG002|Baseline|Total|Total of all reporting groups
11387089|NCT01024608|FG000|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387090|NCT01024608|FG001|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387091|NCT01024608|OG000|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387092|NCT01024608|OG001|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387093|NCT01024608|EG000|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387094|NCT01024608|EG001|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387095|NCT00988247|BG000|Baseline|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387096|NCT00988247|BG001|Baseline|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11197245|NCT02170025|EG001|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
11197246|NCT02170051|BG000|Baseline|CBSST-CCT|"Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training~CBSST-CCT"
11197247|NCT02170051|BG001|Baseline|Goal-focused Supportive Contact|"Goal-focused supportive contact~Goal focused supportive contact"
11387097|NCT00988247|BG002|Baseline|Total|Total of all reporting groups
11387098|NCT00988247|FG000|Participant Flow|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387099|NCT00988247|FG001|Participant Flow|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387100|NCT00988247|OG000|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387101|NCT00988247|OG001|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387102|NCT00988247|EG000|Reported Event|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
11387103|NCT00988247|EG001|Reported Event|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
11387104|NCT00838981|BG000|Baseline|Modafinil Plus CM|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
11387105|NCT00838981|BG001|Baseline|Modafinil Plus Voucher Control|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
11387106|NCT00838981|BG002|Baseline|Sugar Pill Plus CM|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug"
11387107|NCT00838981|BG003|Baseline|Sugar Pill Plus Voucher Control|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug"
11387108|NCT00838981|BG004|Baseline|Total|Total of all reporting groups
11387109|NCT00838981|FG000|Participant Flow|Modafinil Plus Contingency Management|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
11387110|NCT00838981|FG001|Participant Flow|Modafinil Plus Voucher Control|Modafinil from 200mg up to 400mg plus the voucher control
11197248|NCT02170051|BG002|Baseline|Total|Total of all reporting groups
11387111|NCT00838981|FG002|Participant Flow|Placebo Plus Voucher Control|Sugar pill plus voucher control
11387112|NCT00838981|FG003|Participant Flow|Placebo Plus Contingency Management|Sugar pill plus contingency management
11387113|NCT00838981|OG000|Outcome|Modafinil Plus Contingency Magagement|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
11387114|NCT00838981|OG001|Outcome|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
11387115|NCT00838981|OG002|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the"
11387116|NCT00838981|OG003|Outcome|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b"
11387117|NCT00838981|OG000|Outcome|Modafinil Plus Contingency Magagement|"Modafinil from 200mg up to 400mg plus Contingency Management~Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
11387118|NCT00838981|OG002|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Methadone: Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
11387119|NCT00838981|OG003|Outcome|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
11387120|NCT00838981|OG002|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
11387121|NCT00838981|EG000|Reported Event|Modafinil Plus Contingency Magagement|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
11387122|NCT00838981|EG001|Reported Event|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
11387123|NCT00838981|EG002|Reported Event|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the"
11387124|NCT00838981|EG003|Reported Event|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b"
11387125|NCT00730639|BG000|Baseline|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387126|NCT00730639|BG001|Baseline|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387127|NCT00730639|BG002|Baseline|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11197249|NCT02170051|FG000|Participant Flow|CBSST-CCT|"Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training~CBSST-CCT"
11197250|NCT02170051|FG001|Participant Flow|Goal-focused Supportive Contact|"Goal-focused supportive contact~Goal focused supportive contact"
11387128|NCT00730639|BG003|Baseline|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387129|NCT00730639|BG004|Baseline|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387130|NCT00730639|BG005|Baseline|Total|Total of all reporting groups
11387131|NCT00730639|FG000|Participant Flow|0.1 mg/kg Nivolumab|0.1 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg)was administered intravenously (IV) every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, partial response (PR), or stable disease (SD), who subsequently experienced confirmed PD.
11387132|NCT00730639|FG001|Participant Flow|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
11387133|NCT00730639|FG002|Participant Flow|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
11387134|NCT00730639|FG003|Participant Flow|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
11387135|NCT00730639|FG004|Participant Flow|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
11387136|NCT00730639|OG000|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387137|NCT00730639|OG001|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387138|NCT00730639|OG002|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387139|NCT00730639|OG003|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387140|NCT00730639|OG004|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387141|NCT00730639|OG000|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
11387142|NCT00730639|OG001|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
11387143|NCT00730639|OG002|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
11387144|NCT00730639|OG003|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
11387145|NCT00730639|OG004|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
10803589|NCT03278626|OG000|Outcome|Nivolimumab+Carboplatin/Paclitaxel+Radiation|"240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation~Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64))."
11387146|NCT00730639|OG005|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
11387147|NCT00730639|OG000|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
11387148|NCT00730639|OG001|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
11387149|NCT00730639|OG002|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
11387150|NCT00730639|OG003|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
11387151|NCT00730639|OG004|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
11387152|NCT00730639|EG000|Reported Event|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387153|NCT00730639|EG001|Reported Event|0.3 mg/kg Nivolumab|IV solution of 0.3 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387154|NCT00730639|EG002|Reported Event|1 mg/kg Nivolumab|IV solution of 1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387155|NCT00730639|EG003|Reported Event|3 mg/kg Nivolumab|IV solution of 3 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387156|NCT00730639|EG004|Reported Event|10 mg/kg Nivolumab|IV solution of 10 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
11387157|NCT00363038|BG000|Baseline|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
11387158|NCT00363038|FG000|Participant Flow|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
11387159|NCT00363038|OG000|Outcome|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
11387160|NCT00363038|EG000|Reported Event|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
11197251|NCT02170051|OG000|Outcome|CBSST-CCT|"Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training~CBSST-CCT"
11387161|NCT04834362|BG000|Baseline|Analog Insulin Arm|"Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.~Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.~For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L."
11387162|NCT04834362|BG001|Baseline|Human Insulin Arm|"Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm~Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm."
11387163|NCT04834362|BG002|Baseline|Total|Total of all reporting groups
11387164|NCT04834362|FG000|Participant Flow|Analog Insulin Arm|"Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.~Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.~For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L."
11387165|NCT04834362|FG001|Participant Flow|Human Insulin Arm|"Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm~Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm."
11387166|NCT04834362|OG000|Outcome|Analog Insulin Arm|"Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.~Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.~For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L."
11387167|NCT04834362|OG001|Outcome|Human Insulin Arm|"Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm~Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm."
11387168|NCT04834362|EG000|Reported Event|Analog Insulin Arm|"Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.~Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.~For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L."
11387169|NCT04834362|EG001|Reported Event|Human Insulin Arm|"Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm~Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm."
11387170|NCT04681482|BG000|Baseline|Warfarin|Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
11387171|NCT04681482|BG001|Baseline|Apixaban|Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387172|NCT04681482|BG002|Baseline|Dabigatran|Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387173|NCT04681482|BG003|Baseline|Rivaroxaban|Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387174|NCT04681482|BG004|Baseline|Total|Total of all reporting groups
11387175|NCT04681482|FG000|Participant Flow|Warfarin|Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
11387176|NCT04681482|FG001|Participant Flow|Apixaban|Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387177|NCT04681482|FG002|Participant Flow|Dabigatran|Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387178|NCT04681482|FG003|Participant Flow|Rivaroxaban|Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387179|NCT04681482|OG000|Outcome|Warfarin|Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
11387180|NCT04681482|OG001|Outcome|Apixaban|Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387181|NCT04681482|OG002|Outcome|Dabigatran|Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387182|NCT04681482|OG003|Outcome|Rivaroxaban|Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387183|NCT04681482|EG000|Reported Event|Warfarin|Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
11387184|NCT04681482|EG001|Reported Event|Apixaban|Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387185|NCT04681482|EG002|Reported Event|Dabigatran|Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387186|NCT04681482|EG003|Reported Event|Rivaroxaban|Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
11387187|NCT04611789|BG000|Baseline|Placebo|Participants received single subcutaneous dose of Placebo.
11387188|NCT04611789|BG001|Baseline|350 mg LY3832479|Participants received single subcutaneous dose of 350 mg LY3832479.
11387189|NCT04611789|BG002|Baseline|1000 mg LY3832479|Participants received single subcutaneous dose of 1000 mg LY3832479.
11387190|NCT04611789|BG003|Baseline|Total|Total of all reporting groups
11387191|NCT04611789|FG000|Participant Flow|Placebo|Participants received single subcutaneous dose of Placebo.
11387192|NCT04611789|FG001|Participant Flow|350 mg LY3832479|Participants received single subcutaneous dose of 350 mg LY3832479.
11197252|NCT02170051|OG001|Outcome|Goal-focused Supportive Contact|"Goal-focused supportive contact~Goal focused supportive contact"
11387193|NCT04611789|FG002|Participant Flow|1000 mg LY3832479|Participants received single subcutaneous dose of 1000 mg LY3832479.
11387194|NCT04611789|OG000|Outcome|350 mg LY3832479|Participants received single subcutaneous dose of 350 mg LY3832479.
11387195|NCT04611789|OG001|Outcome|1000 mg LY3832479|Participants received single subcutaneous dose of 1000 mg LY3832479.
11387196|NCT04611789|EG000|Reported Event|Placebo SC|Participants received single subcutaneous dose of Placebo.
11387197|NCT04611789|EG001|Reported Event|350 mg LY3832479 SC|Participants received single subcutaneous dose of 350 mg LY3832479.
11387198|NCT04611789|EG002|Reported Event|1000 mg LY3832479 SC|Participants received single subcutaneous dose of 1000 mg LY3832479.
11387199|NCT04537910|BG000|Baseline|Placebo SC|Participants received a single SC dose of Placebo.
11387200|NCT04537910|BG001|Baseline|150 mg LY3819253 SC|Participants received a single SC dose of 150 mg LY3819253.
11387201|NCT04537910|BG002|Baseline|350 mg LY3819253 SC|Participants received a single SC dose of 350 mg LY3819253.
11387202|NCT04537910|BG003|Baseline|700 mg LY3819253 SC|Participants received a single SC dose of 700 mg LY3819253.
11387203|NCT04537910|BG004|Baseline|Total|Total of all reporting groups
11387204|NCT04537910|FG000|Participant Flow|Placebo SC|Participants received a single subcutaneous (SC) dose of Placebo.
11387205|NCT04537910|FG001|Participant Flow|150 Milligram (mg) LY3819253 SC|Participants received a single SC dose of 150 mg LY3819253.
11387206|NCT04537910|FG002|Participant Flow|350 mg LY3819253 SC|Participants received a single SC dose of 350 mg LY3819253.
11387207|NCT04537910|FG003|Participant Flow|700 mg LY3819253 SC|Participants received a single SC dose of 700 mg LY3819253.
11387208|NCT04537910|OG000|Outcome|150 mg LY3819253 SC|Participants received a single SC dose of 150 mg LY3819253.
11387209|NCT04537910|OG001|Outcome|350 mg LY3819253 SC|Participants received a single SC dose of 350 mg LY3819253.
11387210|NCT04537910|OG002|Outcome|700 mg LY3819253 SC|Participants received a single SC dose of 700 mg LY3819253.
11387211|NCT04537910|EG000|Reported Event|Placebo SC|Participants received a single SC dose of Placebo.
11387212|NCT04537910|EG001|Reported Event|150 mg LY3819253 SC|Participants received a single SC dose of 150 mg LY3819253.
11387213|NCT04537910|EG002|Reported Event|350 mg LY3819253 SC|Participants received a single SC dose of 350 mg LY3819253.
11387214|NCT04537910|EG003|Reported Event|700 mg LY3819253 SC|Participants received a single SC dose of 700 mg LY3819253.
11387215|NCT04441931|BG000|Baseline|Pooled Placebo|Participants received single Intravenous (IV) dose of Placebo.
11387216|NCT04441931|BG001|Baseline|700 mg LY3832479 IV|Participants received single IV dose of 700 mg LY3832479.
11387217|NCT04441931|BG002|Baseline|2800 mg LY3832479 IV|Participants received single IV dose of 2800 mg LY3832479.
11387218|NCT04441931|BG003|Baseline|7000 mg LY3832479 IV|Participants received single IV dose of 7000 mg LY3832479.
11387219|NCT04441931|BG004|Baseline|Total|Total of all reporting groups
11387220|NCT04441931|FG000|Participant Flow|Pooled Placebo|Participants received single Intravenous (IV) dose of Placebo.
11387221|NCT04441931|FG001|Participant Flow|700 mg LY3832479 IV|Participants received single IV dose of 700 mg LY3832479.
11387222|NCT04441931|FG002|Participant Flow|2800 mg LY3832479 IV|Participants received single IV dose of 2800 mg LY3832479.
11387223|NCT04441931|FG003|Participant Flow|7000 mg LY3832479 IV|Participants received single IV dose of 7000 mg LY3832479.
11387224|NCT04441931|OG000|Outcome|Pooled Placebo|Participants received single Intravenous (IV) dose of Placebo.
11387225|NCT04441931|OG001|Outcome|700 mg LY3832479 IV|Participants received single IV dose of 700 mg LY3832479.
11387226|NCT04441931|OG002|Outcome|2800 mg LY3832479 IV|Participants received single IV dose of 2800 mg LY3832479.
11387227|NCT04441931|OG003|Outcome|7000 mg LY3832479 IV|Participants received single IV dose of 7000 mg LY3832479.
11197253|NCT02170051|EG000|Reported Event|CBSST-CCT|"Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training~CBSST-CCT"
11387228|NCT04441931|OG000|Outcome|700 mg LY3832479 IV|Participants received single IV dose of 700 mg LY3832479.
11387229|NCT04441931|OG001|Outcome|2800 mg LY3832479 IV|Participants received single IV dose of 2800 mg LY3832479.
11387230|NCT04441931|OG002|Outcome|7000 mg LY3832479 IV|Participants received single IV dose of 7000 mg LY3832479.
11387231|NCT04441931|EG000|Reported Event|Pooled Placebo IV|Participants received single Intravenous (IV) dose of Placebo.
11387232|NCT04441931|EG001|Reported Event|700 mg LY3832479 IV|Participants received single IV dose of 700 mg LY3832479.
11387233|NCT04441931|EG002|Reported Event|2800 mg LY3832479 IV|Participants received single IV dose of 2800 mg LY3832479.
11387234|NCT04441931|EG003|Reported Event|7000 mg LY3832479 IV|Participants received single IV dose of 7000 mg LY3832479.
11241363|NCT02486588|BG000|Baseline|10% Cash, no Weekly SMS, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11241364|NCT02486588|BG001|Baseline|10% Cash, General Weekly SMS, Standard Monthly SMS|"10% cash back, general weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241365|NCT02486588|BG002|Baseline|10% Cash Back, Personal Weekly SMS, Standard Monthly SMS|"10 % cash back, personalized weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241366|NCT02486588|BG003|Baseline|25% Cash Back, Personal Weekly SMS, Standard Monthly SMS|"25% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241367|NCT02486588|BG004|Baseline|10+15%NET Cash, Personal Weekly SMS, Standard Weekly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241368|NCT02486588|BG005|Baseline|10+15%NET Cash, Personal Weekly SMS, Unbundled Monthly SMS|"10%+15% cash back, personal weekly message, unbundled monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241369|NCT02486588|BG006|Baseline|Total|Total of all reporting groups
11241370|NCT02486588|FG000|Participant Flow|10% Cash, no Weekly Message, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11241371|NCT02486588|FG001|Participant Flow|10% Cash, General Weekly SMS, Standard Monthly SMS|"10% cash back, general weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241372|NCT02486588|FG002|Participant Flow|10% Cash, Personal Weekly SMS, Standard Monthly SMS|"10 % cash back, personalized weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241373|NCT02486588|FG003|Participant Flow|25% Cash, Personal Weekly SMS, Standard Monthly SMS|"25% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241374|NCT02486588|FG004|Participant Flow|10+15%NET Cash, Personal Weekly SMS, Standard Monthly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241375|NCT02486588|FG005|Participant Flow|10+15%NET, Personal Weekly SMS, Unbundled Monthly SMS|"10%+15% cash back, personal weekly message, unbundled monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241376|NCT02486588|OG000|Outcome|10% Cash, no Weekly SMS, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11241377|NCT02486588|OG001|Outcome|10% Cash, General Weekly SMS, Standard Monthly SMS|"10% cash back, general weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11387235|NCT04355728|BG000|Baseline|UC-MSCs Group|"Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment."
11241378|NCT02486588|OG002|Outcome|10% Cash, Personal Weekly SMS, Standard Monthly SMS|"10 % cash back, personalized weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241379|NCT02486588|OG003|Outcome|25% Cash, Personal Weekly SMS, Standard Monthly SMS|"25% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241380|NCT02486588|OG004|Outcome|10+15% Cash, Personal Weekly SMS, Standard Monthly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241381|NCT02486588|OG005|Outcome|10+15%NET Cash, Personal Weekly SMS, Unbundled Monthly SMS|"10%+15% cash back, personal weekly message, unbundled monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11387236|NCT04355728|BG001|Baseline|Control Group|"Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol."
11387237|NCT04355728|BG002|Baseline|Total|Total of all reporting groups
11387238|NCT04355728|FG000|Participant Flow|UC-MSCs Group|"Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment."
11387239|NCT04355728|FG001|Participant Flow|Control Group|"Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol."
11387240|NCT04355728|OG000|Outcome|UC-MSCs Group|"Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment."
11387241|NCT04355728|OG001|Outcome|Control Group|"Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol."
11387242|NCT04355728|EG000|Reported Event|UC-MSCs Group|"Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment."
11387243|NCT04355728|EG001|Reported Event|Control Group|"Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.~Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol."
11387244|NCT04344535|BG000|Baseline|Convalescent Donor Plasma|Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
11387245|NCT04344535|BG001|Baseline|Standard Donor Plasma|Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
11387246|NCT04344535|BG002|Baseline|Total|Total of all reporting groups
11387247|NCT04344535|FG000|Participant Flow|Convalescent Donor Plasma|Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
11387248|NCT04344535|FG001|Participant Flow|Standard Donor Plasma|Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
11387249|NCT04344535|OG000|Outcome|Convalescent Donor Plasma|Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
11387250|NCT04344535|OG001|Outcome|Standard Donor Plasma|Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
11387251|NCT04344535|EG000|Reported Event|Convalescent Donor Plasma|Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
11387252|NCT04344535|EG001|Reported Event|Standard Donor Plasma|Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
11387253|NCT04254809|BG000|Baseline|Re-Evaluating Suicidal Thoughts|"Participants in this condition will complete the experimental intervention at the baseline appointment.~Re-Evaluating Suicidal Thoughts: Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them."
11387254|NCT04254809|BG001|Baseline|Healthy Social Living|"Participants in this condition will complete the sham control intervention at the baseline appointment, and given the option to complete the experimental intervention at the conclusion of the follow-up period.~Healthy Social Living: To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension."
11387255|NCT04254809|BG002|Baseline|Total|Total of all reporting groups
11387256|NCT04254809|FG000|Participant Flow|Re-Evaluating Suicidal Thoughts|"Participants in this condition will complete the experimental intervention at the baseline appointment.~Re-Evaluating Suicidal Thoughts: Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them."
11387257|NCT04254809|FG001|Participant Flow|Healthy Social Living|"Participants in this condition will complete the sham control intervention at the baseline appointment, and given the option to complete the experimental intervention at the conclusion of the follow-up period.~Healthy Social Living: To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension."
11387258|NCT04254809|OG000|Outcome|Re-Evaluating Suicidal Thoughts|"Participants in this condition will complete the experimental intervention at the baseline appointment.~Re-Evaluating Suicidal Thoughts: Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them."
11387259|NCT04254809|OG001|Outcome|Healthy Social Living|"Participants in this condition will complete the sham control intervention at the baseline appointment, and given the option to complete the experimental intervention at the conclusion of the follow-up period.~Healthy Social Living: To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension."
11387260|NCT04254809|EG000|Reported Event|Re-Evaluating Suicidal Thoughts|"Participants in this condition will complete the experimental intervention at the baseline appointment.~Re-Evaluating Suicidal Thoughts: Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them."
11387261|NCT04254809|EG001|Reported Event|Healthy Social Living|"Participants in this condition will complete the sham control intervention at the baseline appointment, and given the option to complete the experimental intervention at the conclusion of the follow-up period.~Healthy Social Living: To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension."
11387262|NCT04230122|BG000|Baseline|10 mg LY3478006 - IV|Participants received single dose of 10 mg LY3478006 administered IV.
11387263|NCT04230122|BG001|Baseline|Placebo - IV|Participants received single dose of placebo administered IV.
11387264|NCT04230122|BG002|Baseline|Total|Total of all reporting groups
11387265|NCT04230122|FG000|Participant Flow|10 Milligram (mg) LY3478006 - Intravenous (IV)|Participants received single dose of 10 mg LY3478006 administered IV.
11387266|NCT04230122|FG001|Participant Flow|Placebo - IV|Participants received single dose of placebo administered IV.
11387267|NCT04230122|OG000|Outcome|10 mg LY3478006 - IV|Participants received single dose of 10 mg LY3478006 administered IV.
11387268|NCT04230122|OG001|Outcome|Placebo - IV|Participants received single dose of placebo administered IV.
11387269|NCT04230122|EG000|Reported Event|10 mg LY3478006 IV|Participants received single dose of placebo administered IV.
11387270|NCT04230122|EG001|Reported Event|Placebo IV|Participants received single dose of 10 mg LY3478006 administered IV.
11197254|NCT02170051|EG001|Reported Event|Goal-focused Supportive Contact|"Goal-focused supportive contact~Goal focused supportive contact"
11197255|NCT02170064|BG000|Baseline|Group 1 (2-6 Yrs)|Efficacy population (EP)
11197256|NCT02170064|BG001|Baseline|Group 2 (7-11 Yrs)|Efficacy population (EP)
11197257|NCT02170064|BG002|Baseline|Group 3 (12-17 Yrs)|Efficacy population (EP)
11197258|NCT02170064|BG003|Baseline|Total|Total of all reporting groups
11387271|NCT04110366|BG000|Baseline|Live Attenuated Influenza Vaccine|Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.
11387272|NCT04110366|BG001|Baseline|Mucosal Immune Stability Cohort|In the placebo/vehicle challenge 'Mucosal immune stability' arm, a further n=8 participants attended for a single visit at which repeat nasal samples were collected to match the LAIV arm.
11387273|NCT04110366|BG002|Baseline|Total|Total of all reporting groups
11387274|NCT04110366|FG000|Participant Flow|Live Attenuated Influenza Vaccine|Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.
11387275|NCT04110366|FG001|Participant Flow|Mucosal Immune Stability Cohort|Vehicle control nasal challenge recipients n=8
11387276|NCT04110366|OG000|Outcome|Live Attenuated Influenza Vaccine|"Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.~n=31 participants (78%) shed at least one vaccine virus, measured by qPCR, on at least one study timepoint."
11387277|NCT04110366|OG001|Outcome|Mucosal Immune Stability Cohort|Stability of cytokine levels measured in nasosorption samples collected from participants for the 8 hour duration of this arm. Cytokines measured by multiplex immunoassays.
11387278|NCT04110366|OG000|Outcome|Live Attenuated Influenza Vaccine|Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.
11387279|NCT04110366|EG000|Reported Event|Live Attenuated Influenza Vaccine|Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.
11387280|NCT04110366|EG001|Reported Event|Mucosal Immune Stability Cohort|In the placebo/vehicle challenge 'Mucosal immune stability' arm, a further n=8 participants attended for a single 8 hour visit at which repeat nasal samples were collected to match the LAIV arm.
11387281|NCT04086693|BG000|Baseline|Standard IV Dressing|"Polyurethane dressing with clear tape~Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV"
11387282|NCT04086693|BG001|Baseline|Standard IV Dressing Plus Adhezion SecurePortIV|"Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device).~Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV"
11387283|NCT04086693|BG002|Baseline|Total|Total of all reporting groups
11387284|NCT04086693|FG000|Participant Flow|Standard IV Dressing|"Polyurethane dressing with clear tape~Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV"
11387285|NCT04086693|FG001|Participant Flow|Standard IV Dressing Plus Adhezion SecurePortIV|"Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device).~Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV"
11387286|NCT04086693|OG000|Outcome|Standard IV Dressing|"Polyurethane dressing with clear tape~Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV"
11387287|NCT04086693|OG001|Outcome|Standard IV Dressing Plus Adhezion SecurePortIV|"Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device).~Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV"
11387288|NCT04086693|EG000|Reported Event|Standard IV Dressing|"Polyurethane dressing with clear tape~Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV"
11387289|NCT04086693|EG001|Reported Event|Standard IV Dressing Plus Adhezion SecurePortIV|"Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device).~Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV"
11387290|NCT04033068|BG000|Baseline|Group A: V187 (High Dose) - V187 (High Dose)|Participants receive V187 at a high dose of 1x10^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.
11387291|NCT04033068|BG001|Baseline|Group B: V187 (Low Dose) - V187 (Low Dose)|Participants receive V187 at a low dose of 2.5x10^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387292|NCT04033068|BG002|Baseline|Group C: V187 (High Dose) - Placebo|Participants receive V187 at a high dose of 1x10^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.
11387293|NCT04033068|BG003|Baseline|Group D: Placebo - Placebo|Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387294|NCT04033068|BG004|Baseline|Total|Total of all reporting groups
10803929|NCT01049035|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
11387295|NCT04033068|FG000|Participant Flow|Group A: V187 (High Dose) - V187 (High Dose)|Participants receive V187 at a high dose of 1x10^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.
11197259|NCT02170064|FG000|Participant Flow|Group 1 (2-6 Yrs)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (compassionate use) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.~For Group 1 (2-6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit."
11241382|NCT02486588|OG004|Outcome|10+15%NET, Personal Weekly SMS, Standard Monthly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11387296|NCT04033068|FG001|Participant Flow|Group B: V187 (Low Dose) - V187 (Low Dose)|Participants receive V187 at a low dose of 2.5x10^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387297|NCT04033068|FG002|Participant Flow|Group C: V187 (High Dose) - Placebo|Participants receive V187 at a high dose of 1x10^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.
11387298|NCT04033068|FG003|Participant Flow|Group D: Placebo - Placebo|Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387299|NCT04033068|OG000|Outcome|Group A: V187 (High Dose) - V187 (High Dose)|Participants receive V187 at a high dose of 1x10^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.
11387300|NCT04033068|OG001|Outcome|Group B: V187 (Low Dose) - V187 (Low Dose)|Participants receive V187 at a low dose of 2.5x10^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387301|NCT04033068|OG002|Outcome|Group C: V187 (High Dose) - Placebo|Participants receive V187 at a high dose of 1x10^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.
11387302|NCT04033068|OG003|Outcome|Group D: Placebo - Placebo|Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387303|NCT04033068|EG000|Reported Event|Group A: V187 (High Dose) - V187 (High Dose)|Participants receive V187 at a high dose of 1x10^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.
11387304|NCT04033068|EG001|Reported Event|Group B: V187 (Low Dose) - V187 (Low Dose)|Participants receive V187 at a low dose of 2.5x10^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387305|NCT04033068|EG002|Reported Event|Group C: V187 (High Dose) - Placebo|Participants receive V187 at a high dose of 1x10^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.
11387306|NCT04033068|EG003|Reported Event|Group D: Placebo - Placebo|Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
11387307|NCT03561597|BG000|Baseline|Mobile Health Application|"Participants will undergo Kurbo program, a Mobile health application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. The patient's progress will be reviewed by the nurse clinician at one month post intervention to determine whether the BMI percentile has shown a reduction through the Kurbo Program. Patients that declined Kurbo intervention, has a BMI of more than 99th percentile or continue to have increase in their BMI percentile in Kurbo program, will be offered the high risk weight management clinic appointment for a more detailed multidisciplinary evaluation for targeted intervention. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic (WMC). There will be a month 3 and month 6 visit for study measurements in this study.~Mobile health intervention: The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period."
11387308|NCT03561597|FG000|Participant Flow|Mobile Health Application|"Participants will undergo Kurbo program, a Mobile health application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. The patient's progress will be reviewed by the nurse clinician at one month post intervention to determine whether the BMI percentile has shown a reduction through the Kurbo Program. Patients that declined Kurbo intervention, has a BMI of more than 99th percentile or continue to have increase in their BMI percentile in Kurbo program, will be offered the high risk weight management clinic appointment for a more detailed multidisciplinary evaluation for targeted intervention. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic (WMC). There will be a month 3 and month 6 visit for study measurements in this study.~Mobile health intervention: The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period."
11387309|NCT03561597|OG000|Outcome|Mobile Health Application|"Participants will undergo Kurbo program, a Mobile health application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. The patient's progress will be reviewed by the nurse clinician at one month post intervention to determine whether the BMI percentile has shown a reduction through the Kurbo Program. Patients that declined Kurbo intervention, has a BMI of more than 99th percentile or continue to have increase in their BMI percentile in Kurbo program, will be offered the high risk weight management clinic appointment for a more detailed multidisciplinary evaluation for targeted intervention. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic (WMC). There will be a month 3 and month 6 visit for study measurements in this study.~Mobile health intervention: The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period."
11387310|NCT03561597|EG000|Reported Event|Mobile Health Application|"Participants will undergo Kurbo program, a Mobile health application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. The patient's progress will be reviewed by the nurse clinician at one month post intervention to determine whether the BMI percentile has shown a reduction through the Kurbo Program. Patients that declined Kurbo intervention, has a BMI of more than 99th percentile or continue to have increase in their BMI percentile in Kurbo program, will be offered the high risk weight management clinic appointment for a more detailed multidisciplinary evaluation for targeted intervention. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic (WMC). There will be a month 3 and month 6 visit for study measurements in this study.~Mobile health intervention: The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period."
11387311|NCT03402607|BG000|Baseline|Percutaneous Local Abalation (PLA)|"A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.~Percutaneous Local Abalation: Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk."
11387312|NCT03402607|BG001|Baseline|Hypofractionated Image-Guided Radiation Therapy (HIGRT)|"HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.~Hypofractionated Image Guided Radiation Therapy: HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted."
11387313|NCT03402607|BG002|Baseline|Total|Total of all reporting groups
11387314|NCT03402607|FG000|Participant Flow|Percutaneous Local Abalation (PLA)|"A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.~Percutaneous Local Abalation: Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk."
11387315|NCT03402607|FG001|Participant Flow|Hypofractionated Image-Guided Radiation Therapy (HIGRT)|"HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.~Hypofractionated Image Guided Radiation Therapy: HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted."
11387316|NCT03402607|OG000|Outcome|Percutaneous Local Abalation (PLA)|"A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.~Percutaneous Local Abalation: Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk."
11387317|NCT03402607|OG001|Outcome|Hypofractionated Image-Guided Radiation Therapy (HIGRT)|"HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.~Hypofractionated Image Guided Radiation Therapy: HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted."
11387318|NCT03402607|EG000|Reported Event|Percutaneous Local Abalation (PLA)|"A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.~Percutaneous Local Abalation: Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk."
11387319|NCT03402607|EG001|Reported Event|Hypofractionated Image-Guided Radiation Therapy (HIGRT)|"HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.~Hypofractionated Image Guided Radiation Therapy: HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted."
11387320|NCT03350984|BG000|Baseline|NPH Insulin Group|"Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin~NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL."
11387321|NCT03350984|BG001|Baseline|Glargine and Lispro Insulin Group|"Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.~Intervention drug: Glargine and Lispro~Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner."
11387322|NCT03350984|BG002|Baseline|Total|Total of all reporting groups
11387323|NCT03350984|FG000|Participant Flow|NPH Insulin Group|"Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin~NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL."
11387324|NCT03350984|FG001|Participant Flow|Glargine and Lispro Insulin Group|"Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.~Intervention drug: Glargine and Lispro~Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner."
11387325|NCT03350984|OG000|Outcome|NPH Insulin Group|"Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin~NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL."
11387326|NCT03350984|OG001|Outcome|Glargine and Lispro Insulin Group|"Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.~Intervention drug: Glargine and Lispro~Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner."
11387327|NCT03350984|EG000|Reported Event|NPH Insulin Group|"Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin~NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL."
11387328|NCT03350984|EG001|Reported Event|Glargine and Lispro Insulin Group|"Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.~Intervention drug: Glargine and Lispro~Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner."
11387329|NCT03277261|BG000|Baseline|Ublituximab + Oral Placebo|Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.
11387330|NCT03277261|BG001|Baseline|Teriflunomide + IV Placebo|Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387331|NCT03277261|BG002|Baseline|Total|Total of all reporting groups
11387332|NCT03277261|FG000|Participant Flow|Ublituximab + Oral Placebo|Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95.
11387333|NCT03277261|FG001|Participant Flow|Teriflunomide + IV Placebo|Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387334|NCT03277261|OG000|Outcome|Ublituximab + Oral Placebo|Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.
11387335|NCT03277261|OG001|Outcome|Teriflunomide + IV Placebo|Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387336|NCT03277261|OG001|Outcome|Teriflunomide + IV Placebo|Participants were administered Teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387337|NCT03277261|EG000|Reported Event|Ublituximab + Oral Placebo|Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.
11387338|NCT03277261|EG001|Reported Event|Teriflunomide + IV Placebo|Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387339|NCT03277248|BG000|Baseline|Ublituximab + Oral Placebo|Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
11387340|NCT03277248|BG001|Baseline|Teriflunomide + IV Placebo|Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387341|NCT03277248|BG002|Baseline|Total|Total of all reporting groups
11197260|NCT02170064|FG001|Participant Flow|Group 2 (7-11 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (compassionate use) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.~For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
11387342|NCT03277248|FG000|Participant Flow|Ublituximab + Oral Placebo|Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.
11387343|NCT03277248|FG001|Participant Flow|Teriflunomide + IV Placebo|Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387344|NCT03277248|OG000|Outcome|Ublituximab + Oral Placebo|Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
11387345|NCT03277248|OG001|Outcome|Teriflunomide + IV Placebo|Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11387346|NCT03277248|EG000|Reported Event|Ublituximab + Oral Placebo|Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
11387347|NCT03277248|EG001|Reported Event|Teriflunomide + IV Placebo|Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
11241383|NCT02486588|OG005|Outcome|10+15%NET, Personal Weekly SMS, Unbundled Monthly SMS|"10%+15% cash back, personal weekly message, unbundled monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241384|NCT02486588|OG000|Outcome|10% Cash, no Weekly SNS, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11387348|NCT03179462|BG000|Baseline|Pork Intake|"Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.~Pork intake: Each participant will consume 2 ounces of cooked lean pork."
11387349|NCT03179462|BG001|Baseline|Mixed Nuts Intake|"Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.~Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts."
11387350|NCT03179462|BG002|Baseline|Tofu Intake|"Subjects will consume 2 ounces of tofu following diet normalization for 3 days.~Tofu intake: Each participant will consume 2 ounces of tofu."
11387351|NCT03179462|BG003|Baseline|Total|Total of all reporting groups
11387352|NCT03179462|FG000|Participant Flow|Pork Intake|"Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.~Pork intake: Each participant will consume 2 ounces of cooked lean pork."
11387353|NCT03179462|FG001|Participant Flow|Mixed Nuts Intake|"Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.~Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts."
11387354|NCT03179462|FG002|Participant Flow|Tofu Intake|"Subjects will consume 2 ounces of tofu following diet normalization for 3 days.~Tofu intake: Each participant will consume 2 ounces of tofu."
11387355|NCT03179462|OG000|Outcome|Pork Intake|"Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.~Pork intake: Each participant will consume 2 ounces of cooked lean pork."
11387356|NCT03179462|OG001|Outcome|Mixed Nuts Intake|"Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.~Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts."
11387357|NCT03179462|OG002|Outcome|Tofu Intake|"Subjects will consume 2 ounces of tofu following diet normalization for 3 days.~Tofu intake: Each participant will consume 2 ounces of tofu."
11387358|NCT03179462|EG000|Reported Event|Pork Intake|"Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.~Pork intake: Each participant will consume 2 ounces of cooked lean pork."
11387359|NCT03179462|EG001|Reported Event|Mixed Nuts Intake|"Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.~Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts."
11387360|NCT03179462|EG002|Reported Event|Tofu Intake|"Subjects will consume 2 ounces of tofu following diet normalization for 3 days.~Tofu intake: Each participant will consume 2 ounces of tofu."
11387361|NCT03099707|BG000|Baseline|Standard of Care|Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only. This group will not receive any additional engagement to care intervention. Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).
11387362|NCT03099707|BG001|Baseline|Treatment Ambassador Intervention|"Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys). For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation. The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.~Treatment Ambassador: This multi-component intervention, titled the Treatment Ambassador Program, will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support."
11387363|NCT03099707|BG002|Baseline|Total|Total of all reporting groups
11387364|NCT03099707|FG000|Participant Flow|Standard of Care|Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only. This group will not receive any additional engagement to care intervention. Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).
11387365|NCT03099707|FG001|Participant Flow|Treatment Ambassador Intervention|"Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys). For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation. The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.~Treatment Ambassador: This multi-component intervention, titled the Treatment Ambassador Program, will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support."
11387366|NCT03099707|OG000|Outcome|Standard of Care|Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only. This group will not receive any additional engagement to care intervention. Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).
11387367|NCT03099707|OG001|Outcome|Treatment Ambassador Intervention|"Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys). For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation. The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.~Treatment Ambassador: This multi-component intervention, titled the Treatment Ambassador Program, will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support."
11387368|NCT03099707|EG000|Reported Event|Standard of Care|Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only. This group will not receive any additional engagement to care intervention. Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).
11241385|NCT02486588|OG004|Outcome|10+15%NET Cash, Personal Weekly SMS, Standard Monthly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11387369|NCT03099707|EG001|Reported Event|Treatment Ambassador Intervention|"Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys). For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation. The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.~Treatment Ambassador: This multi-component intervention, titled the Treatment Ambassador Program, will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support."
11387370|NCT03064763|BG000|Baseline|Talimogene Laherparepvec|"Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.~On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10^8 or 10^7 PFU/mL. The second dose was to be administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were to be given every 2 weeks (+ 3 days). Participants can receive talimogene laherparepvec for a maximum treatment duration of 48 months. At the time of data cutoff the median treatment duration was 23.14 weeks (min = 3.1 weeks; max = 89.1 weeks)."
11387371|NCT03064763|FG000|Participant Flow|Talimogene Laherparepvec|"Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.~On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10^8 or 10^7 PFU/mL. The second dose was to be administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were to be given every 2 weeks (+ 3 days). Participants can receive talimogene laherparepvec for a maximum treatment duration of 48 months. At the time of data cutoff the median treatment duration was 23.14 weeks (min = 3.1 weeks; max = 89.1 weeks)."
11387372|NCT03064763|OG000|Outcome|Talimogene Laherparepvec|"Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.~On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10^8 or 10^7 PFU/mL. The second dose was to be administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were to be given every 2 weeks (+ 3 days). Participants can receive talimogene laherparepvec for a maximum treatment duration of 48 months. At the time of data cutoff the median treatment duration was 23.14 weeks (min = 3.1 weeks; max = 89.1 weeks)."
11387373|NCT03064763|EG000|Reported Event|Talimogene Laherparepvec|"Participants received talimogene laherparepvec administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance.~On Day 1 (Week 0), the initial dose of talimogene laherparepvec was up to 4.0 mL of 10^6 Plaque forming units per millilitre (PFU/mL). Subsequent doses of talimogene laherparepvec were up to 4.0 mL of 10^8 or 10^7 PFU/mL. The second dose was to be administered 3 weeks (+ 5 days) after the initial dose, and subsequent doses were to be given every 2 weeks (+ 3 days). Participants can receive talimogene laherparepvec for a maximum treatment duration of 48 months. At the time of data cutoff the median treatment duration was 23.14 weeks (min = 3.1 weeks; max = 89.1 weeks)."
11387374|NCT03036267|BG000|Baseline|Focus Groups|Six focus group were held with adults with asthma and their (adult) loved ones
11387375|NCT03036267|FG000|Participant Flow|Focus Groups|Six focus group were held with adults with asthma and their (adult) loved ones
11387376|NCT03036267|OG000|Outcome|Focus Groups|Six focus group were held with adults with asthma and their (adult) loved ones
11387377|NCT03036267|EG000|Reported Event|Focus Groups|Six focus group were held with adults with asthma and their (adult) loved ones
11387378|NCT02941146|BG000|Baseline|CoolSculpting of the Abdomen With Dual Applicators|Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
11387379|NCT02941146|FG000|Participant Flow|CoolSculpting of the Abdomen|Non-invasive fat reduction of the abdomen will be performed using the Zeltiq CoolSculpting System.
11387380|NCT02941146|OG000|Outcome|CoolSculpting of the Abdomen With Dual Applicators|Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
11387381|NCT02941146|EG000|Reported Event|CoolSculpting of the Abdomen With Dual Applicators|Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
11387382|NCT02922985|BG000|Baseline|Placebo Control Group|"Patients will receive a placebo dose of all three study medications~Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group."
11387383|NCT02922985|BG001|Baseline|Multimodal Pain Regimen Group|"Patients will receive the actual study medication for all three study medications.~Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery~Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure~Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision."
11387384|NCT02922985|BG002|Baseline|Total|Total of all reporting groups
11387385|NCT02922985|FG000|Participant Flow|Placebo Control Group|"Patients will receive a placebo dose of all three study medications~Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group."
11241386|NCT02486588|OG000|Outcome|10% Cash, no Weekly Message, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11241387|NCT02486588|EG000|Reported Event|10% Cash, no Weekly SMS, Standard Monthly SMS|10% cash back level, no weekly message, and the standard monthly message
11387386|NCT02922985|FG001|Participant Flow|Multimodal Pain Regimen Group|"Patients will receive the actual study medication for all three study medications.~Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery~Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure~Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision."
11387387|NCT02922985|OG000|Outcome|Placebo Control Group|"Patients will receive a placebo dose of all three study medications~Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group."
11387388|NCT02922985|OG001|Outcome|Multimodal Pain Regimen Group|"Patients will receive the actual study medication for all three study medications.~Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery~Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure~Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision."
11387389|NCT02922985|OG000|Outcome|Placebo Control Group|"Patients will receive a placebo dose of all three study medications: Patients will receive the pre-operative dose of IV normal saline placebo within 30 minutes of going to the OR for CD. The patient will receive the subcutaneous infiltration of 20 mL of subcutaneous normal saline placebo after positioning and preparation but prior to skin incision. At the time of fascial closure, the patient will receive an IM dose of normal saline placebo.~Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group."
11387390|NCT02922985|OG001|Outcome|Multimodal Pain Regimen Group|"Patients will receive the actual study medication for all three study medications: Patients will receive the pre-operative dose of IV acetaminophen 1 g within 30 minutes of going to the OR for CD. The patient will receive the subcutaneous infiltration of either 20 mL of bupivacaine 0.25% after positioning and preparation but prior to skin incision. At the time of fascial closure, the patient will receive 60 mg of IM ketorolac.~Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery~Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure~Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision."
11387391|NCT02922985|EG000|Reported Event|Placebo Control Group|"Patients will receive a placebo dose of all three study medications~Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group."
11387392|NCT02922985|EG001|Reported Event|Multimodal Pain Regimen Group|"Patients will receive the actual study medication for all three study medications.~Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery~Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure~Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision."
11387393|NCT02906033|BG000|Baseline|Intervention Group|"New perioperative practice model.~New perioperative practice model: The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery."
11387394|NCT02906033|BG001|Baseline|Control Group|Traditional practice model.
11387395|NCT02906033|BG002|Baseline|Total|Total of all reporting groups
11387396|NCT02906033|FG000|Participant Flow|Intervention Group|"New perioperative practice model.~New perioperative practice model: The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery."
11387397|NCT02906033|FG001|Participant Flow|Control Group|Traditional practice model.
11387398|NCT02906033|OG000|Outcome|Intervention Group|"New perioperative practice model.~New perioperative practice model: The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery."
11387399|NCT02906033|OG001|Outcome|Control Group|Traditional practice model.
11387400|NCT02906033|EG000|Reported Event|Intervention Group|"New perioperative practice model.~New perioperative practice model: The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery."
11387401|NCT02906033|EG001|Reported Event|Control Group|Traditional practice model.
11387402|NCT02837783|BG000|Baseline|Matching Placebo|Placebo once daily for 4 weeks
11387403|NCT02837783|BG001|Baseline|290 μg Linaclotide|290 μg linaclotide once daily for 4 weeks
11387404|NCT02837783|BG002|Baseline|Total|Total of all reporting groups
11387405|NCT02837783|FG000|Participant Flow|Matching Placebo|Placebo once daily for 4 weeks
11387406|NCT02837783|FG001|Participant Flow|290 μg Linaclotide|290 µg linaclotide once daily for 4 weeks
11387407|NCT02837783|OG000|Outcome|Matching Placebo|Placebo once daily for 4 weeks
11387408|NCT02837783|OG001|Outcome|290 μg Linaclotide|290 μg linaclotide once daily for 4 weeks
11387409|NCT02837783|EG000|Reported Event|Matching Placebo|Placebo once daily for 4 weeks
11387410|NCT02837783|EG001|Reported Event|290 μg Linaclotide|290 μg linaclotide once daily for 4 weeks
11387411|NCT02786537|BG000|Baseline|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily with RBV for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet) once daily with or without food with or without RBV for 12 to 16 weeks (with RBV)"
11387412|NCT02786537|BG001|Baseline|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily without RBV for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet): 1 tablet once daily with or without food with or without RBV for 12 to 16 weeks (without RBV)"
11387413|NCT02786537|BG002|Baseline|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks with Ribavirin (RBV) (treatment duration and use of ribavirin is per discretion of HCV provider)"
11387414|NCT02786537|BG003|Baseline|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (per discretion of provider)~SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg tablet ) 1 tablet orally once daily for approximately 12 to 24 weeks"
11387415|NCT02786537|BG004|Baseline|PROD With RBV (Phase 1 Only)|"Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks +/- RBV (provider discretion)~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir: 250 mg daily for 12 to 24 weeks"
11387416|NCT02786537|BG005|Baseline|PROD (Phase 1 Only)|"Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks Dasabuvir: 250 mg daily for 12 to 24 weeks"
11387417|NCT02786537|BG006|Baseline|Total|Total of all reporting groups
11387418|NCT02786537|FG000|Participant Flow|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily with RBV for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food and with RBV: Ribavirin (200 mg pill) 1-3 pills/day, once or twice daily. Total daily dosage ranged from 200 to 1200 mg."
11387419|NCT02786537|FG001|Participant Flow|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily (without RBV) for 12 to 16 weeks~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks. Duration of treatment according to HCV treatment provider."
11387420|NCT02786537|FG002|Participant Flow|SOF/LDV With RBV|"Patients received SOF/LDV(sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV/sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) 1 tablet daily for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) RBV (200 mg pill): 1-3 pills, once or twice daily (dosing per discretion of HCV provider). Total daily dosage ranged from 200 to 1200 mg."
11387421|NCT02786537|FG003|Participant Flow|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks~SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider)"
11387422|NCT02786537|FG004|Participant Flow|PrOD/RBV(Phase 1 Only)|"PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir (Viekira) once or twice daily with a meal for 12 to 24 weeks + RBV (provider discretion). Randomization to PrOD discontinued January 2017.~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks with food (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir: 250 mg twice daily for 12 to 24 weeks with a meal RBV: Ribavirin 200 to 600 mg once or twice daily"
11387423|NCT02786537|FG005|Participant Flow|PrOD (Phase 1 Only)|"Randomization to Prod discontinued January 2017 (defining end of Phase 1) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration as per HCV provider)~Dasabuvir: 250 mg daily for 12 to 24 weeks"
11387424|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387425|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks~EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks"
11197261|NCT02170064|FG002|Participant Flow|Group 3 (12-17 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (compassionate use) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.~For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
11387426|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387427|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387428|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received elbasvir/grazoprevir (EBR/GZR) tablet orally once daily with or without Ribavirin (RBV) for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks Ribavirin (RBV) (200 mg pill)- 1-3 pills orally once or twice daily (dosage at provider discretion)"
11387429|NCT02786537|OG001|Outcome|EBR/GZR|Patients received elbasvir/grazoprevir (EBR/GZR) once daily for 12 to 16 weeks EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks
11387430|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (treatment duration per discretion of provider)~sofosbuvir/ledipasvir: 1 Sofosbuvir/Ledipasvir (400/90 mg) tablet once daily with or without food for approximately 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (treatment duration and dosage of ribavirin as per discretion of HCV provider)"
11387431|NCT02786537|OG003|Outcome|SOF/LDV|Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily for 12 to 24 weeks (treatment duration as per discretion of HCV treatment provider) SOF/LDV (400/90 MG TABLET): 1 tablet orally once daily for 12 to 24 weeks
11387432|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks~EBR/GZR (50/100mg) tablet: 1 tablet once daily with or without food 12 to 16 weeks"
11387433|NCT02786537|OG004|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV)~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider)~RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)"
11387434|NCT02786537|OG005|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks"
11387435|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily with Ribavirin (RBV) for 12 to 16 weeks (provider discretion)~EBR/GZR: Elbasvir/grazoprevir (50/100mg) 1 tablet once daily with or without food with or without RBV for 12 to 16 weeks~Ribavirin at dosages ranging from 200mg to 600 mg daily (or twice daily) can be added to HCV DAA treatment regimen at discretion of HCV treatment provider"
11387436|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily without RBV for 12 to 16 weeks (provider discretion)~EBR/GZR: 1 Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food for 12 to 16 weeks"
11387437|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) tablet orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)~RBV: At discretion of provider, 200 mg pill, 1-3 pills/day, 1-2 times/day (daily dosing ranging from 200mg to 1200 mg daily) added to HCV treatment regimen"
11387438|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV (Sofosbuvir/Ledipasvir 400/90 mg tablet): 1 tablet daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)"
11387439|NCT02786537|OG004|Outcome|PrOD With RBV|"Patients received PrOD (ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily) for 12 to 24 weeks with Ribavirin (RBV) (use and dosage at provider discretion)~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet ) 2 tablets daily for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 500 mg tablet once or twice daily (morning and evening)~RBV: At discretion of provider, 200 mg pill, 1-3 pills/day, 1-2 times/day (daily dosing ranging from 200mg to 1200 mg daily) added to HCV treatment regimen"
11387440|NCT02786537|OG005|Outcome|PrOD (Phase 1 Only)|"Patients received ProD (ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily) for 12 to 24 weeks without Ribavirin (at provider discretion)~ombitasvir/paritaprevir/ritonavir (Phase 1 only): Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir: 250 mg tablet twice daily for 12 to 24 weeks"
11387441|NCT02786537|OG000|Outcome|EBR/GZR With Ribavirin (RBV)|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily withRBV (at discretion of provider) for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg - 1 tablet once daily with or without food for 12 to 16 weeks RBV: Ribavirin (200 mg pills) 1-3 pills/day, 1-2 times/day (Total dosage 200-1200 mg day)"
11387442|NCT02786537|OG001|Outcome|EBR/GZR Regimen|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily without RBV (at discretion of provider) for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg - 1 tablet once daily with or without food for 12 to 16 weeks"
11197262|NCT02170064|OG000|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
11197263|NCT02170064|OG001|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
11387443|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387444|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387445|NCT02786537|OG004|Outcome|PrOD With RBV Regimen|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~RBV (200 mg pill): 1-3 pills once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)"
11387446|NCT02786537|OG005|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)"
11387447|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg to 600mg tablet): 1 to 3 tablets once or twice daily (dosage and duration per discretion of provider)"
11387448|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir ) once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks"
11197264|NCT02170064|OG002|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
11197265|NCT02170064|EG000|Reported Event|Group 1 (2-6 Yrs)|Safety population (SP)
11197266|NCT02170064|EG001|Reported Event|Group 2 (7-11 Yrs)|Safety population (SP)
11197267|NCT02170064|EG002|Reported Event|Group 3 (12-17 Yrs)|Safety population (SP)
11197268|NCT02170077|BG000|Baseline|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
11197269|NCT02170077|BG001|Baseline|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
11197270|NCT02170077|BG002|Baseline|PLG - Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
11197271|NCT02170077|BG003|Baseline|Total|Total of all reporting groups
11197272|NCT02170077|FG000|Participant Flow|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
11197273|NCT02170077|FG001|Participant Flow|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
11197274|NCT02170077|FG002|Participant Flow|PLG - Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
11197275|NCT02170077|OG000|Outcome|ODG - Once Daily Group|Intent to treat (TT) Population
11197276|NCT02170077|OG001|Outcome|TDG - Twice Daily Group|Intent to treat (TT) Population
11197277|NCT02170077|OG002|Outcome|PLG - Placebo Group|Intent to treat (TT) Population
11197278|NCT02170077|EG000|Reported Event|ODG - Once Daily Group|Intent to treat (TT) Population
11197279|NCT02170077|EG001|Reported Event|TDG - Twice Daily Group|Intent to treat (TT) Population
11197280|NCT02170077|EG002|Reported Event|PLG - Placebo Group|Intent to treat (TT) Population
11197281|NCT02170207|BG000|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
11197282|NCT02170207|FG000|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
11197283|NCT02170207|OG000|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
11197284|NCT02170207|EG000|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
11197285|NCT02170220|BG000|Baseline|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
11197286|NCT02170220|BG001|Baseline|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
11197287|NCT02170220|BG002|Baseline|Total|Total of all reporting groups
11197288|NCT02170220|FG000|Participant Flow|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
11197289|NCT02170220|FG001|Participant Flow|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
11197290|NCT02170220|OG000|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
11197291|NCT02170220|OG001|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
11197292|NCT02170220|EG000|Reported Event|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
11197293|NCT02170220|EG001|Reported Event|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
11197300|NCT02170376|BG000|Baseline|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197301|NCT02170376|BG001|Baseline|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197302|NCT02170376|BG002|Baseline|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197303|NCT02170376|BG003|Baseline|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11387449|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387450|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387451|NCT02786537|OG000|Outcome|EBR/GZR (Elbasvir/Grazoprevir) With RBV|"Patients received 1 EBR/GZR (elbasvir/grazoprevir) (Zepatier) tablet (50/100mg) once daily for 12 to 16 weeks (provider discretion) with Ribavirin (RBV)~EBR/GZR (elbasvir/grazoprevir): Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks~Ribavirin: 200 mg/tablet, 1-3/day, taken 1-2 times per day (dosage at discretion of provider)."
11387452|NCT02786537|OG001|Outcome|EBR/GZR (Elbasvir/Grazoprevir)|"Patients received 1 EBR/GZR (elbasvir/grazoprevir) tablet (50/100 mg) once daily for 12 to 16 weeks (treatment duration per provider discretion)~EBR/GZR (elbasvir/grazoprevir): Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food for 12 to 16 weeks"
11387453|NCT02786537|OG002|Outcome|SOF/LDV (Sofosbuvir/Ledipasvir) With RBV|"Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) (Harvoni) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (duration and usage of RBV at discretion of provider).~SOF/LDV (sofosbuvir/ledipasvir): Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks~Ribavirin (RBV): 200 mg/tablet(capsule), 1-3 pills/day, 1-2 times/day."
11387454|NCT02786537|OG003|Outcome|SOF/LDV (Sofosbuvir/Ledipasvir)|"Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV (sofosbuvir/ledipasvir): Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration at discretion of HCV provider)"
11387455|NCT02786537|OG004|Outcome|PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) With RBV (Phase 1 Only)|"Patients received Pr0D (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) orally daily with food for 12 to 24 weeks with RBV (Ribavirin).~Ombitasvir/Paritaprevir/Ritonavir (12.5/75/50 mg/tablet) -2 tablets once daily with food for 12 to 24 weeks and 1 dasabuvir tablet (250 mg) twice daily with food for 12 to 24 weeks.~RBV (200 mg/pill) 1-3 pills/day, 1-2 times/day (use and dosage at provider discretion). Total daily RBV dosage ranged from 200 to 1200 mg."
11387456|NCT02786537|OG005|Outcome|PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir)|"Patients received 2 ombitasvir/paritaprevir/ritonavir tablets (12.5/75/50 mg) once daily and 1 dasabuvir (250 mg) tablet twice daily with food for 12 to 24 weeks without Ribavirin (as per provider instructions)~PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only): Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)"
11387457|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks.~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387458|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks (duration per investigator's discretion)~EBR/GZR (50/100mg) tablet: 1 tablet once daily with or without food 12 to 16 weeks"
11387459|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without RBV~SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387460|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir ) once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg to 600mg tablet): 1 to 3 tablets once or twice daily (dosage and duration per discretion of provider)"
11387461|NCT02786537|OG004|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387462|NCT02786537|OG005|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)"
11387463|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg tablet): 1 to 3 tablets once or twice daily (dosage and duration per discretion of provider)"
11387464|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks"
11387465|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage 200 mg- 1200 mg."
11387466|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387467|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)"
11387468|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks"
11387469|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)~RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)"
11387470|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration as per discretion of HCV provider)"
11387471|NCT02786537|OG004|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)"
11387472|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)"
11387473|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)"
11387474|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg tablet): 1 to 3 tablets, once or twice daily (dosage and duration per discretion of provider). Total daily dosage ranged from 200 to 1200 mg daily."
11387475|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)~RBV (Ribavirin) 200mg tablet: 1 to 3 tablets, once or twice daily at discretion of provider. Total daily dosage ranged from 200 to 1200 mg."
11197304|NCT02170376|BG004|Baseline|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197305|NCT02170376|BG005|Baseline|Total|Total of all reporting groups
11387476|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387477|NCT02786537|OG004|Outcome|PrOD With RBV|"Patients received PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV).~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~RBV (200 mg tablet): 1-3 tablets, 1-2 times per day, daily for 12 to 24 weeks (dosage and duration at discretion of provider)"
11387478|NCT02786537|OG005|Outcome|PrOD|"Patients received PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV).~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)"
11387479|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV (at discretion of provider) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion)~Ribavirin (RBV) 200 mg tablet: 1 - 3 tablets,1-2 times per day, daily for 12 to 16 weeks (dosage and duration per discretion of provider)."
11387480|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily without RBV (at discretion of provider) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion)"
11387481|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food, daily for 12 - 24 weeks (use of RBV and dosage at discretion of provider)"
11387482|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387483|NCT02786537|OG001|Outcome|EBR/GZR Regimen|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks"
11387484|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks with or without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387485|NCT02786537|OG004|Outcome|PrOD Regimen With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387486|NCT02786537|OG005|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV).~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)"
11387487|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received elbasvir/grazoprevir (EBR/GZR) tablet orally once daily with or without Ribavirin (RBV) for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks Ribavirin (RBV) (200 mg tablet)- 1-3 tablets orally, once or twice daily (dosage at provider discretion). Total daily dosage 200 -1200 mg."
11387488|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (treatment duration per discretion of provider)~sofosbuvir/ledipasvir: 1 Sofosbuvir/Ledipasvir (400/90 mg) tablet once daily with or without food for approximately 12 to 24 weeks Ribavirin (200 mg tablet): 1-3 tablets, once or twice daily (treatment duration and dosage of ribavirin as per discretion of HCV provider)."
11387489|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV (at discretion of provider) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet orally once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dose ranging from 200 mg to 1200 mg."
11387490|NCT02786537|OG001|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily without RBV (at discretion of provider) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet orally once daily with or without food for 12 to 16 weeks (duration per provider discretion)"
11387491|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)"
11387492|NCT02786537|OG004|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~RBV (200 mg tablet): 1-3 tablets, once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)."
11387493|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Subjects will take EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg tablet): 1 to 3 tablets, once or twice daily (dosage and duration per discretion of provider)"
11387494|NCT02786537|OG001|Outcome|EBR/GZR|"Subjects will take EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks"
11387495|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration as HCV provider discretion)"
11387496|NCT02786537|OG004|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranging from 200 - 1200 mg."
11387497|NCT02786537|OG000|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV (at discretion of provider) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet orally once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dose ranging from 200 mg to 1200 mg."
11387498|NCT02786537|OG002|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranged from 200 to 1200 mg."
11197306|NCT02170376|FG000|Participant Flow|Group 1: Placebo Then Entacapone/Levodopa|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11387499|NCT02786537|OG003|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387500|NCT02786537|OG000|Outcome|EBR/GZR With RBV-16 Weeks|"Subjects received EBR/GZR (elbasvir/grazoprevir) once daily with Ribavirin (RBV) for 16 weeks (as per provider discretion)~EBR/GZR: Elbasvir/grazoprevir (50/100mg tablet) 1 tablet once daily with or without food~RBV (200 mg tablet): 1-3 tablets once or twice daily for 16 weeks (dosage and duration at discretion of provider). Total dosage ranging from 200 mg to 1200 mg daily."
11387501|NCT02786537|OG000|Outcome|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with or without RBV for 12 to 16 weeks (provider discretion)~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranging from 200-1200 mg."
11387502|NCT02786537|OG001|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with or without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387503|NCT02786537|OG002|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with or without Ribavirin~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)"
11387504|NCT02786537|OG000|Outcome|EBR/GZR Regimen|"Patients received elbasvir/grazoprevir tablet tablet once daily with or without RBV (at discretion of provider) for 12 to 16 weeks (provider discretion)~elbasvir/grazoprevir: Elbasvir/grazoprevir (50/100mg) tablet once daily with food and with RBV: Ribavirin (200 mg/pill) 1-3 pills/day, 1-2 times/day. Total daily dosage ranged from 200 to 1200 mg."
11387505|NCT02786537|OG001|Outcome|SOF/LDV Regimen|"Patients received 1 tablet SOF/LDV(sofosbuvir/ledipasvir) orally once daily with or without ribavirin (RBV) (per discretion of provider) with or without food 12 to 24 weeks~SOF/LDV/sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) RBV: Ribavirin (200mg pill) 1-3 pills, once or twice/day -dosage at discretion of provider. Total daily dosage ranged from 200 to 1200 mg."
11387506|NCT02786537|OG000|Outcome|EBR/GZR, SOF/LDV or PrOD Based HCV Treatment|"Elbasvir/grazoprevir (EBR/GZR): (50/100mg) tablet once daily with food for 12 to 16 weeks with or without RBV (Ribavirin usage as per provider discretion).~Sofosbuvir/ledipasvir (SOF/LDV)/ (400/90 mg) 1 tablet once daily for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) with or without RBV (RBV usage as per provider discretion):~PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks + RBV (provider discretion)~ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir: 250 mg daily for 12 to 24 weeks RBV: Ribavirin 200 to 600 mg once or twice daily RBV (Ribavirin)- 200mg pill, 1-3 pills/day once or twice daily (use and dosing per discretion of HCV provider)."
11387507|NCT02786537|OG000|Outcome|EBR/GZR Regimen|"Subjects will take EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with or without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg to 600mg tablet): 1 to 3 tablets once or twice daily (dosage and duration per discretion of provider)"
11387508|NCT02786537|OG001|Outcome|SOF/LDV Regimen|"Subjects will take 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with or without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387509|NCT02786537|OG000|Outcome|EBR/GZR Regimen|"Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with or without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg to 600mg pill): 1 to 3 pill once or twice daily (dosage and duration per discretion of provider)"
11387510|NCT02786537|OG001|Outcome|SOF/LDV Regimen|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with or without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg pill: 1 to 3 pills once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranged from 200 to 1200 mg."
11387511|NCT02786537|OG000|Outcome|EBR/GZR|"Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks~EBR/GZV (50/100mg) tablet: 1 tablet once daily with or without food 12 to 16 weeks"
11387512|NCT02786537|OG001|Outcome|EBR/GZR With Ribavirin|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387513|NCT02786537|OG002|Outcome|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)"
11387514|NCT02786537|OG003|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranged from 200 to 1200 mg."
11387515|NCT02786537|OG004|Outcome|PrOD|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks"
11387516|NCT02786537|OG005|Outcome|PrOD With RBV|"PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV)~ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider)~RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)"
11387517|NCT02786537|OG000|Outcome|EBR/GZR|"Patients received EBR/GZR tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks~EBR/GZR (50/100mg) tablet: 1 tablet once daily with or without food 12 to 16 weeks"
11387518|NCT02786537|OG001|Outcome|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV (Ribavirin) for 12 to 16 weeks~EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387519|NCT02786537|OG003|Outcome|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387520|NCT02786537|OG000|Outcome|EBR/GZR Regimen|"Patients received EBR/GZR (elbasvir/grazoprevir) once daily for 12 to 16 weeks (duration of treatment per provider discretion) with or without Ribavirin (RBV) (per provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks~RBV(Ribavirin) (200mg to 600mg tablet): 1 to 3 tablets once or twice daily (usage, dosage and duration per discretion of provider) (Total dosage ranging from 200 mg to 1200 mg daily)"
11387521|NCT02786537|OG001|Outcome|SOF/LDV Regimen|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with or without ribavirin (RBV) (per discretion of provider)~SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)~Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)"
11387522|NCT02786537|EG000|Reported Event|EBR/GZR|"Patients received EBR/GZR (elbasvir/grazoprevir) tablet once daily without RBV for 12 to 16 weeks (provider discretion)~EBR/GZR: Elbasvir/grazoprevir (50/100mg tablet) 1 tablet once daily with or without food"
11387523|NCT02786537|EG001|Reported Event|EBR/GZR With RBV|"Patients received EBR/GZR (elbasvir/grazoprevir tablet) tablet once daily with Ribavirin (RBV) for 12 to 16 weeks (provider discretion)~EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food with RBV (200 to 600 mg once or twice daily) for 12 to 16 weeks"
11387524|NCT02786537|EG002|Reported Event|SOF/LDV With RBV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)~SOF/LDV (Sofosbuvir/Ledipasvir) (400/90 mg tablet) 1 tablet taken daily for approximately 12 to 24 weeks with RBV (Ribavirin) 200 mg: 1-3 pills, one to two times daily (dosage at discretion of HCV provider). Total daily dosage ranged fro 200 to 1200 mg."
11387525|NCT02786537|EG003|Reported Event|SOF/LDV|"Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks (treatment duration per discretion of provider)~SOF/LDV (Sofosbuvir/Ledipasvir )(400/90 mg tablet) 1 tablet orally taken daily for approximately 12 to 24 weeks"
11387526|NCT02786537|EG004|Reported Event|PrOD With RBV|"PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) (treatment at duration provider discretion)~ombitasvir/paritaprevir/ritonavir: 2 tablets orally once daily (12.5/75/50mg) for 12 to 24 weeks~Dasabuvir (250 mg tablet): 1 tablet orally once or twice daily for 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (dosage at provider discretion). Total daily dosage ranged from 200 to 1200 mg."
11387527|NCT02786537|EG005|Reported Event|PrOD|"Patients received PrOD orally (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV) (provider discretion)~Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg): 2 tablets taken once orally daily for 12 to 24 weeks (treatment duration as per HCV provider)~Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks"
11387528|NCT02740231|BG000|Baseline|Reference Product|Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
11387529|NCT02740231|BG001|Baseline|JTA-004 50 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387530|NCT02740231|BG002|Baseline|JTA-004 50 (4 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387531|NCT02740231|BG003|Baseline|JTA-004 100 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387532|NCT02740231|BG004|Baseline|Total|Total of all reporting groups
11387533|NCT02740231|FG000|Participant Flow|Reference Product|Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
11387534|NCT02740231|FG001|Participant Flow|JTA-004 50 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387535|NCT02740231|FG002|Participant Flow|JTA-004 50 (4 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387536|NCT02740231|FG003|Participant Flow|JTA-004 100 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387537|NCT02740231|OG000|Outcome|JTA-004 100 (2 mL)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387538|NCT02740231|OG001|Outcome|Reference Product|Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
11387539|NCT02740231|OG000|Outcome|JTA-004 100 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387540|NCT02740231|OG000|Outcome|JTA-004 (All Strenghts)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387541|NCT02740231|EG000|Reported Event|Reference Product|Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
11387542|NCT02740231|EG001|Reported Event|JTA-004 50 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387543|NCT02740231|EG002|Reported Event|JTA-004 50 (4 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11387544|NCT02740231|EG003|Reported Event|JTA-004 100 (2 ml)|JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
11197307|NCT02170376|FG001|Participant Flow|Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11387545|NCT02710084|BG000|Baseline|Saline Then Oxytocin|During the first phase, patients randomized to the placebo group received intranasal saline solution in doses of 24 IU two times daily, for a total of 48 IU. During the second phase of the study, all participants received intranasal oxytocin, in identical doses.
11387546|NCT02710084|BG001|Baseline|Intranasal Oxytocin|The first phase of the study followed a double-blind, placebo-controlled design. Participants randomized to the experimental group received intranasal oxytocin started the trial with a dose of 24 international units (IU) twice daily (BID), which was adjusted to 12 IU BID, subsequently the dose was increased to 24IU BID. Each insufflation delivered 4 IU and three insufflations (12 IU) in each nostril were given twice daily for a total daily dose of 48 IU. The second phase was a 12-week open-label extension phase during which all participants received intranasal oxytocin.
11387547|NCT02710084|BG002|Baseline|Total|Total of all reporting groups
11387548|NCT02710084|FG000|Participant Flow|Saline Then Oxytocin|During the first phase, patients randomized to the placebo group received intranasal saline solution in doses of 24 IU two times daily, for a total of 48 IU. During the second phase of the study, all participants received intranasal oxytocin, in identical doses.
11387549|NCT02710084|FG001|Participant Flow|Intranasal Oxytocin|The first phase of the study followed a double-blind, placebo-controlled design. Participants randomized to the experimental group received intranasal oxytocin started the trial with a dose of 24 international units (IU) twice daily (BID), which was adjusted to 12 IU BID, subsequently the dose was increased to 24IU BID. Each insufflation delivered 4 IU and three insufflations (12 IU) in each nostril were given twice daily for a total daily dose of 48 IU. The second phase was a 12-week open-label extension phase during which all participants received intranasal oxytocin.
11387550|NCT02710084|OG000|Outcome|Saline Then Oxytocin|During the first phase, patients randomized to the placebo group received intranasal saline solution in doses of 24 IU two times daily, for a total of 48 IU. During the second phase of the study, all participants received intranasal oxytocin, in identical doses.
11387551|NCT02710084|OG001|Outcome|Intranasal Oxytocin|The first phase of the study followed a double-blind, placebo-controlled design. Participants randomized to the experimental group received intranasal oxytocin started the trial with a dose of 24 international units (IU) twice daily (BID), which was adjusted to 12 IU BID, subsequently the dose was increased to 24IU BID. Each insufflation delivered 4 IU and three insufflations (12 IU) in each nostril were given twice daily for a total daily dose of 48 IU. The second phase was a 12-week open-label extension phase during which all participants received intranasal oxytocin.
11387552|NCT02710084|OG001|Outcome|Intranasal Oxytocin|The first phase of the study will follow a double-blind, placebo-controlled design. Participants randomized to the experimental group will receive intranasal oxytocin started the trial with a dose of 24 international units (IU) twice daily (BID), which was adjusted to 12 IU BID, subsequently the dose was increased to 24IU BID. Each insufflation delivered 4 IU and three insufflations (12 IU) in each nostril were given twice daily for a total daily dose of 48 IU.
11197308|NCT02170376|FG002|Participant Flow|Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11387553|NCT02710084|EG000|Reported Event|Saline|During the first phase, patients randomized to the placebo group received intranasal saline solution in doses of 24 IU two times daily, for a total of 48 IU.
11387554|NCT02710084|EG001|Reported Event|Intranasal Oxytocin|The first phase of the study followed a double-blind, placebo-controlled design. Participants randomized to the experimental group received intranasal oxytocin started the trial with a dose of 24 international units (IU) twice daily (BID), which was adjusted to 12 IU BID, subsequently the dose was increased to 24IU BID. Each insufflation delivered 4 IU and three insufflations (12 IU) in each nostril were given twice daily for a total daily dose of 48 IU. During the second phase of the study, all participants received oxytocin, in identical doses.
11387555|NCT02660034|BG000|Baseline|Part A: Dose Escalation Phase - Cohort 1|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387556|NCT02660034|BG001|Baseline|Part A: Dose Escalation Phase - Cohort 2|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387557|NCT02660034|BG002|Baseline|Part A: Dose Escalation Phase - Cohort 3|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387558|NCT02660034|BG003|Baseline|Part A: Dose Escalation Phase - Cohort 4|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387559|NCT02660034|BG004|Baseline|Part A: Dose Escalation Phase - Cohort 5|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387560|NCT02660034|BG005|Baseline|Part B: Dose Expansion Phase - Arm 1a|Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387561|NCT02660034|BG006|Baseline|Part B: Dose Expansion Phase - Arm 1b|Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.
11387562|NCT02660034|BG007|Baseline|Part B: Dose Expansion Phase - Arm 2|Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.
11387563|NCT02660034|BG008|Baseline|Part B: Dose Expansion Phase - Arm 3|Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.
11387564|NCT02660034|BG009|Baseline|Part B: Dose Expansion Phase - Arm 4|Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387565|NCT02660034|BG010|Baseline|Part B: Dose Expansion Phase - Arm 5|Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.
11387566|NCT02660034|BG011|Baseline|Part B: Dose Expansion Phase - Arm 6|Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387567|NCT02660034|BG012|Baseline|Part B: Dose Expansion Phase - Arm 7|Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.
11387568|NCT02660034|BG013|Baseline|Part B: Dose Expansion Phase - Arm 8|Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
11387569|NCT02660034|BG014|Baseline|Total|Total of all reporting groups
11387570|NCT02660034|FG000|Participant Flow|Part A: Dose Escalation Phase - Cohort 1|Participants received tislelizumab (2 milligrams/kilogram [mg/kg] once every 3 weeks [Q3W] intravenously [IV]) with pamiparib (20 mg twice daily) (dose escalation) until determination of the maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D).
11387571|NCT02660034|FG001|Participant Flow|Part A: Dose Escalation Phase - Cohort 2|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11241388|NCT02486588|EG001|Reported Event|10% Cash, General Weekly SMS, Standard Monthly SMS|"10% cash back, general weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11387572|NCT02660034|FG002|Participant Flow|Part A: Dose Escalation Phase - Cohort 3|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387573|NCT02660034|FG003|Participant Flow|Part A: Dose Escalation Phase - Cohort 4|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387574|NCT02660034|FG004|Participant Flow|Part A: Dose Escalation Phase - Cohort 5|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387575|NCT02660034|FG005|Participant Flow|Part B: Dose Expansion Phase - Arm 1a|Participants with relapsed, platinum-sensitive, high-grade epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) with either known germline or somatic breast cancer susceptibility gene 1/2 (BRCA1/2) mutations or with homologous recombination deficiency (HRD) received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387576|NCT02660034|FG006|Participant Flow|Part B: Dose Expansion Phase - Arm 1b|Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.
11387577|NCT02660034|FG007|Participant Flow|Part B: Dose Expansion Phase - Arm 2|Participants with triple negative breast cancer (TNBC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.
11387578|NCT02660034|FG008|Participant Flow|Part B: Dose Expansion Phase - Arm 3|Participants with metastatic castration-resistant prostate cancer (mCRPC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.
11387579|NCT02660034|FG009|Participant Flow|Part B: Dose Expansion Phase - Arm 4|Participants with extensive-stage disease small cell lung cancer (SCLC) treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387580|NCT02660034|FG010|Participant Flow|Part B: Dose Expansion Phase - Arm 5|Participants with human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.
11387581|NCT02660034|FG011|Participant Flow|Part B: Dose Expansion Phase - Arm 6|Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387582|NCT02660034|FG012|Participant Flow|Part B: Dose Expansion Phase - Arm 7|Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.
11387583|NCT02660034|FG013|Participant Flow|Part B: Dose Expansion Phase - Arm 8|Participants who were expected to benefit from the combination of a poly (ADP-ribose) polymerase (PARP) inhibitor and a programmed cell death 1 (PD-1) inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be mismatch repair [MMR] deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
11387584|NCT02660034|OG000|Outcome|Part A: Dose Escalation Phase - Cohort 1|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387585|NCT02660034|OG001|Outcome|Part A: Dose Escalation Phase - Cohort 2|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387586|NCT02660034|OG002|Outcome|Part A: Dose Escalation Phase - Cohort 3|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387587|NCT02660034|OG003|Outcome|Part A: Dose Escalation Phase - Cohort 4|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387588|NCT02660034|OG004|Outcome|Part A: Dose Escalation Phase - Cohort 5|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387589|NCT02660034|OG000|Outcome|Part B: Dose Expansion Phase - Arm 1a|Participants with relapsed, platinum-sensitive, high-grade EOC with either known germline or somatic BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387590|NCT02660034|OG001|Outcome|Part B: Dose Expansion Phase - Arm 1b|Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.
11387591|NCT02660034|OG002|Outcome|Part B: Dose Expansion Phase - Arm 2|Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.
11387592|NCT02660034|OG003|Outcome|Part B: Dose Expansion Phase - Arm 3|Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.
11387593|NCT02660034|OG004|Outcome|Part B: Dose Expansion Phase - Arm 4|Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387594|NCT02660034|OG005|Outcome|Part B: Dose Expansion Phase - Arm 5|Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.
11387595|NCT02660034|OG006|Outcome|Part B: Dose Expansion Phase - Arm 6|Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387596|NCT02660034|OG007|Outcome|Part B: Dose Expansion Phase - Arm 7|Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.
11387597|NCT02660034|OG008|Outcome|Part B: Dose Expansion Phase - Arm 8|Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
11387598|NCT02660034|OG000|Outcome|Part B: Dose Expansion Phase - Arm 1a|Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387599|NCT02660034|OG007|Outcome|Part B: Dose Expansion Phase - Arm 8|Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
11387600|NCT02660034|OG000|Outcome|Part B: Dose Expansion Phase|Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387601|NCT02660034|OG000|Outcome|Part B: Dose Expansion Phase|Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily
11387602|NCT02660034|EG000|Reported Event|Part A: Dose Escalation Phase - Cohort 1|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387603|NCT02660034|EG001|Reported Event|Part A: Dose Escalation Phase - Cohort 2|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387604|NCT02660034|EG002|Reported Event|Part A: Dose Escalation Phase - Cohort 3|Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387605|NCT02660034|EG003|Reported Event|Part A: Dose Escalation Phase - Cohort 4|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387606|NCT02660034|EG004|Reported Event|Part A: Dose Escalation Phase - Cohort 5|Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
11387607|NCT02660034|EG005|Reported Event|Part B: Dose Expansion Phase - Arm 1a|Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387608|NCT02660034|EG006|Reported Event|Part B: Dose Expansion Phase - Arm 1b|Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.
11387609|NCT02660034|EG007|Reported Event|Part B: Dose Expansion Phase - Arm 2|Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.
11241389|NCT02486588|EG002|Reported Event|10% Cash, Personal Weekly SMS, Standard Monthly SMS|"10 % cash back, personalized weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241390|NCT02486588|EG003|Reported Event|25% Cash, Personal Weekly SMS, Standard Monthly SMS|"25% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241391|NCT02486588|EG004|Reported Event|10+15%NET Cash, Personal Weekly SMS, Standard Monthly SMS|"10%+15% cash back, personal weekly message, standard monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241392|NCT02486588|EG005|Reported Event|10+15%NET Cash, Personal Weekly SMS, Unbundled Monthly SMS|"10%+15% cash back, personal weekly message, unbundled monthly message~Messaging: See detailed study description for overview of the different messaging interventions in this study~Financial incentives: See detailed study description for overview of the different financial incentive-based interventions in this study"
11241393|NCT02486627|BG000|Baseline|Plazomicin|Patients received up to 15 mg/kg plazomicin as an IV infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11387610|NCT02660034|EG008|Reported Event|Part B: Dose Expansion Phase - Arm 3|Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.
11387611|NCT02660034|EG009|Reported Event|Part B: Dose Expansion Phase - Arm 4|Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387612|NCT02660034|EG010|Reported Event|Part B: Dose Expansion Phase - Arm 5|Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.
11387613|NCT02660034|EG011|Reported Event|Part B: Dose Expansion Phase - Arm 6|Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
11387614|NCT02660034|EG012|Reported Event|Part B: Dose Expansion Phase - Arm 7|Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum-naïve.
11387615|NCT02660034|EG013|Reported Event|Part B: Dose Expansion Phase - Arm 8|Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
11387616|NCT02640625|BG000|Baseline|Probiotic Intervention|HIV positive on cART >4 years with CD4 <400 cells/ml and HIV RNA <50 copies/ml
11197309|NCT02170376|FG003|Participant Flow|Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197310|NCT02170376|FG004|Participant Flow|Group 5: Placebo Then Levodopa/Carbidopa|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197311|NCT02170376|OG000|Outcome|Placebo|Placebo: PLC, placebo
11197312|NCT02170376|OG001|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
11197313|NCT02170376|OG002|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
11197314|NCT02170376|OG003|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
11197315|NCT02170376|OG004|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
11197316|NCT02170376|EG000|Reported Event|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197317|NCT02170376|EG001|Reported Event|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197318|NCT02170376|EG002|Reported Event|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197319|NCT02170376|EG003|Reported Event|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197320|NCT02170376|EG004|Reported Event|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
11197321|NCT02170389|BG000|Baseline|Treatment (AGS-003 Immunotherapy, Nephrectomy)|"Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.~Laboratory Biomarker Analysis: Correlative studies~Nephrectomy: Undergo partial or radical nephrectomy~Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID"
11197322|NCT02170389|FG000|Participant Flow|Treatment (AGS-003 Immunotherapy, Nephrectomy)|"Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.~Laboratory Biomarker Analysis: Correlative studies~Nephrectomy: Undergo partial or radical nephrectomy~Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID"
11197323|NCT02170389|OG000|Outcome|Treatment (AGS-003 Immunotherapy, Nephrectomy)|"Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.~Laboratory Biomarker Analysis: Correlative studies~Nephrectomy: Undergo partial or radical nephrectomy~Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID"
11197324|NCT02170389|EG000|Reported Event|Treatment (AGS-003 Immunotherapy, Nephrectomy)|"Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.~Laboratory Biomarker Analysis: Correlative studies~Nephrectomy: Undergo partial or radical nephrectomy~Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003: Given ID"
11197325|NCT02170519|BG000|Baseline|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11387617|NCT02640625|FG000|Participant Flow|Probiotic Compound|"Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.~Probiotic compound: Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus."
11387618|NCT02640625|OG000|Outcome|Probiotic Intervention|HIV positive on cART >4 years with CD4 <400 cells/ml and HIV RNA <50 copies/ml
11387619|NCT02640625|OG000|Outcome|Probiotic Compound|"Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.~Probiotic compound: Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus."
11387620|NCT02640625|EG000|Reported Event|Probiotic Intervention|HIV positive on cART >4 years with CD4 <400 cells/ml and HIV RNA <50 copies/ml
11387621|NCT02561962|BG000|Baseline|Dose Exploration: AMG 224 Dose A|Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
11387622|NCT02561962|BG001|Baseline|Dose Exploration: AMG 224 Dose B|Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387623|NCT02561962|BG002|Baseline|Dose Exploration: AMG 224 Dose C|Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387624|NCT02561962|BG003|Baseline|Dose Exploration: AMG 224 Dose D|Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387625|NCT02561962|BG004|Baseline|Dose Exploration: AMG 224 Dose E|Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387626|NCT02561962|BG005|Baseline|Dose Exploration: AMG 224 Dose F|Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387627|NCT02561962|BG006|Baseline|Dose Exploration: AMG 224 Dose G|Participants were administered AMG 224 Dose G as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
11387628|NCT02561962|BG007|Baseline|Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment|Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387629|NCT02561962|BG008|Baseline|Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment|Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387630|NCT02561962|BG009|Baseline|Total|Total of all reporting groups
11387631|NCT02561962|FG000|Participant Flow|Dose Exploration: AMG 224 Dose A|Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
11387632|NCT02561962|FG001|Participant Flow|Dose Exploration: AMG 224 Dose B|Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387633|NCT02561962|FG002|Participant Flow|Dose Exploration: AMG 224 Dose C|Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387634|NCT02561962|FG003|Participant Flow|Dose Exploration: AMG 224 Dose D|Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387635|NCT02561962|FG004|Participant Flow|Dose Exploration: AMG 224 Dose E|Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387636|NCT02561962|FG005|Participant Flow|Dose Exploration: AMG 224 Dose F|Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387637|NCT02561962|FG006|Participant Flow|Dose Exploration: AMG 224 Dose G|Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387638|NCT02561962|FG007|Participant Flow|Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment|Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387639|NCT02561962|FG008|Participant Flow|Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment|Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387640|NCT02561962|OG000|Outcome|Dose Exploration: AMG 224 Dose A|Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
11387641|NCT02561962|OG001|Outcome|Dose Exploration: AMG 224 Dose B|Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387642|NCT02561962|OG002|Outcome|Dose Exploration: AMG 224 Dose C|Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387643|NCT02561962|OG003|Outcome|Dose Exploration: AMG 224 Dose D|Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387644|NCT02561962|OG004|Outcome|Dose Exploration: AMG 224 Dose E|Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387645|NCT02561962|OG005|Outcome|Dose Exploration: AMG 224 Dose F|Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387646|NCT02561962|OG006|Outcome|Dose Exploration: AMG 224 Dose G|Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387647|NCT02561962|OG007|Outcome|Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment|Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387648|NCT02561962|OG008|Outcome|Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment|Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387649|NCT02561962|EG000|Reported Event|Dose Exploration: AMG 224 Dose A|Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
11241394|NCT02486627|BG001|Baseline|Meropenem|Patients received 1.0 g meropenem as an IV infusion q8h. After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241395|NCT02486627|BG002|Baseline|Total|Total of all reporting groups
11387650|NCT02561962|EG001|Reported Event|Dose Exploration: AMG 224 Dose B|Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387651|NCT02561962|EG002|Reported Event|Dose Exploration: AMG 224 Dose C|Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11241396|NCT02486627|FG000|Participant Flow|Plazomicin|Patients received 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241397|NCT02486627|FG001|Participant Flow|Meropenem|Patients received 1.0 g meropenem as an IV infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241398|NCT02486627|OG000|Outcome|Plazomicin|Patients received up to 15 mg/kg plazomicin as an IV infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241399|NCT02486627|OG001|Outcome|Meropenem|Patients received 1.0 g meropenem as an IV infusion q8h. After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241400|NCT02486627|EG000|Reported Event|Plazomicin|Patients received up to 15 mg/kg plazomicin as an IV infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241401|NCT02486627|EG001|Reported Event|Meropenem|Patients received 1.0 g meropenem as an IV infusion q8h. After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
11241402|NCT02486653|BG000|Baseline|Tamsulosin|"Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: tamsulosin 0.4mg in the evening~Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11241403|NCT02486653|BG001|Baseline|Placebo|"Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: placebo in the evening~Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11241404|NCT02486653|BG002|Baseline|Total|Total of all reporting groups
11241405|NCT02486653|FG000|Participant Flow|Tamsulosin|"Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: tamsulosin 0.4mg in the evening~Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11241406|NCT02486653|FG001|Participant Flow|Placebo|"Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: placebo in the evening~Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11241407|NCT02486653|OG000|Outcome|Tamsulosin|Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
11241408|NCT02486653|OG001|Outcome|Placebo|Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
11241409|NCT02486653|EG000|Reported Event|Tamsulosin|"Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: tamsulosin 0.4mg in the evening~Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11387652|NCT02561962|EG003|Reported Event|Dose Exploration: AMG 224 Dose D|Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387653|NCT02561962|EG004|Reported Event|Dose Exploration: AMG 224 Dose E|Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387654|NCT02561962|EG005|Reported Event|Dose Exploration: AMG 224 Dose F|Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387655|NCT02561962|EG006|Reported Event|Dose Exploration: AMG 224 Dose G|Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387656|NCT02561962|EG007|Reported Event|Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment|Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387657|NCT02561962|EG008|Reported Event|Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment|Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
11387658|NCT02500589|BG000|Baseline|Mood Management Enhancement|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the mood management enhanced smoking cessation arm
11387659|NCT02500589|BG001|Baseline|Health Education Control|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the health education attention control smoking cessation arm
11387660|NCT02500589|BG002|Baseline|Total|Total of all reporting groups
11387661|NCT02500589|FG000|Participant Flow|Mood Management Enhancement|"In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling.~Behavioral mood management: The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls."
11387662|NCT02500589|FG001|Participant Flow|Health Education Control|"In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information.~Health education: In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information."
11387663|NCT02500589|OG000|Outcome|Mood Management Enhancement|"In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling.~Behavioral mood management: The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls."
11387664|NCT02500589|OG001|Outcome|Health Education Control|"In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information.~Health education: In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information."
11387665|NCT02500589|OG000|Outcome|Health Education Control|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms
11387666|NCT02500589|OG001|Outcome|Mood Management Enhancement|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms
11387667|NCT02500589|OG000|Outcome|Mood Management Enhancement|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms
11387668|NCT02500589|OG001|Outcome|Health Education Control|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms
11387669|NCT02500589|EG000|Reported Event|Mood Management Enhancement|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms
11387670|NCT02500589|EG001|Reported Event|Health Education Control|US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptom
11387671|NCT02474329|BG000|Baseline|Cohort 1|"Dutch Parkinson's patients who fulfill the eligibility criteria.~Interventions/Exposures to be administered:~PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling."
11387672|NCT02474329|FG000|Participant Flow|Cohort 1|"Dutch Parkinson's patients who fulfill the eligibility criteria.~Interventions/Exposures to be administered:~PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling."
11387673|NCT02474329|OG000|Outcome|Cohort 1|"Dutch Parkinson's patients resident in the region of Noord-Holland whose fulfill the eligibility criteria.~Interventions/Exposures to be administered:~PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling.~Clinical assessment: During the 13 week follow-up, trained physiotherapists will perform a standardized clinical assessment, based on the PPMI protocol (www.ppmi-info.ors) for every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector: Patients will be asked to wear a smartwatch and a pendant movement sensor, both with triaxial accelerometers, during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling."
11387674|NCT02474329|OG000|Outcome|Cohort 1|"Dutch Parkinson's patients who fulfill the eligibility criteria.~Interventions/Exposures to be administered:~PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling."
11387675|NCT02474329|EG000|Reported Event|Cohort 1 (The Study Only Included 1 Cohort).|"Dutch Parkinson's patients who fulfill the eligibility criteria.~Interventions/Exposures to be administered:~PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.~Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling."
11387676|NCT01976273|BG000|Baseline|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
11387677|NCT01976273|BG001|Baseline|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
11387678|NCT01976273|BG002|Baseline|Total|Total of all reporting groups
11387679|NCT01976273|FG000|Participant Flow|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
11387680|NCT01976273|FG001|Participant Flow|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.~Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
11387681|NCT01976273|OG000|Outcome|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
11387682|NCT01976273|OG001|Outcome|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.~Glycolic Acid Peels"
11387683|NCT01976273|EG000|Reported Event|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
11197326|NCT02170519|BG001|Baseline|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197327|NCT02170519|BG002|Baseline|Total|Total of all reporting groups
11197328|NCT02170519|FG000|Participant Flow|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197329|NCT02170519|FG001|Participant Flow|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197330|NCT02170519|OG000|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197331|NCT02170519|OG000|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197332|NCT02170519|OG001|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197333|NCT02170519|EG000|Reported Event|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197334|NCT02170519|EG001|Reported Event|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
11197335|NCT02170532|BG000|Baseline|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
11197336|NCT02170532|FG000|Participant Flow|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
11387684|NCT01976273|EG001|Reported Event|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.~Glycolic Acid Peels"
11197337|NCT02170532|OG000|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
11197338|NCT02170532|OG001|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
11197339|NCT02170532|OG002|Outcome|Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs|"levalbuterol metered dose inhaler (MDI) 2 puffs~levalbuterol MDI"
11197340|NCT02170532|OG003|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
11197341|NCT02170532|OG004|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
11197342|NCT02170532|OG002|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
11197343|NCT02170532|OG003|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
11197344|NCT02170532|OG004|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
11387685|NCT01722929|BG000|Baseline|Surgery Side and Non-surgery Side|All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound.
11387686|NCT01722929|FG000|Participant Flow|Surgery Side and Non-surgery Side|"This is a split-body, parallel-designed study. All study participants had the skin sensor (the same intervention) placed near the site of their surgery wound, and also on a site without any surgery wound.~Since this is split-body design with one intervention, participant flow will be limited to all study participants as one group to not double-count the number of participants."
11387687|NCT01722929|OG000|Outcome|Skin Sensor on Surgery Side|"Skin sensor will be placed on the side that had surgery.~Sensor on surgery side.~This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side."
11387688|NCT01722929|OG001|Outcome|Skin Sensor on Non-surgery Side|"Skin sensor will be placed on the contralateral side from surgery site.~Sensor on non-surgery side~This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side."
11387689|NCT01722929|EG000|Reported Event|Surgery Side and Non-surgery Side|"The skin sensor intervention was placed on both a surgery site and a non-surgery site in the same participant. This reflects all participants that received the intervention. The Arms/Groups Surgery Side and Non-surgery Side are combined because they both received the same intervention (skin sensor)."
11387690|NCT01500733|BG000|Baseline|Elderly Cohort|Chronic lymphocytic leukemia patients 65 years or older
11387691|NCT01500733|BG001|Baseline|TP53 Cohort|Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
11387692|NCT01500733|BG002|Baseline|Total|Total of all reporting groups
11387693|NCT01500733|FG000|Participant Flow|Elderly Cohort|Chronic lymphocytic leukemia patients 65 years or older
11387694|NCT01500733|FG001|Participant Flow|TP53 Cohort|Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
11387695|NCT01500733|OG000|Outcome|Elderly Cohort|Chronic lymphocytic leukemia patients 65 years or older
11387696|NCT01500733|OG001|Outcome|TP53 Cohort|Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
11387697|NCT01500733|EG000|Reported Event|Elderly Cohort|Chronic lymphocytic leukemia patients 65 years or older
11387698|NCT01500733|EG001|Reported Event|TP53 Cohort|Chronic lymphocytic leukemia patients having T53 aberration, either due to deletion of chromosome 17p or TP53 mutation
11387699|NCT01388491|BG000|Baseline|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
11387700|NCT01388491|BG001|Baseline|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
11387701|NCT01388491|BG002|Baseline|Total|Total of all reporting groups
11387702|NCT01388491|FG000|Participant Flow|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
11387703|NCT01388491|FG001|Participant Flow|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
11387704|NCT01388491|OG000|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
11387705|NCT01388491|OG001|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
11387706|NCT01388491|EG000|Reported Event|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
11387707|NCT01388491|EG001|Reported Event|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
11387708|NCT01373151|BG000|Baseline|Placebo+MTX|"BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo~BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387709|NCT01373151|BG001|Baseline|Clazakizumab(25)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387710|NCT01373151|BG002|Baseline|Clazakizumab(100)|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387711|NCT01373151|BG003|Baseline|Clazakizumab(100)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387712|NCT01373151|BG004|Baseline|Clazakizumab(200)|"BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11197345|NCT02170532|EG000|Reported Event|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
11197346|NCT02170649|BG000|Baseline|Fasting Period|single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
11241410|NCT02486653|EG001|Reported Event|Placebo|"Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.~Outline of schedule:~Day 1-7: placebo in the evening~Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol~Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
11241411|NCT02486692|BG000|Baseline|Phase II-Experimental|"Participants using AboutFace~AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD."
11241412|NCT02486692|BG001|Baseline|Phase II- Usual Care Condition|Education and Print materials only
11241413|NCT02486692|BG002|Baseline|Total|Total of all reporting groups
11241414|NCT02486692|FG000|Participant Flow|Phase II-Experimental|"Participants using AboutFace~AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD."
11241415|NCT02486692|FG001|Participant Flow|Phase II- Usual Care Condition|Education and Print materials only
11241416|NCT02486692|OG000|Outcome|Phase II-Experimental|"Participants using AboutFace~AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD."
11241417|NCT02486692|OG001|Outcome|Phase II- Usual Care Condition|Education and Print materials only
11241418|NCT02486692|EG000|Reported Event|Phase II- Experimental|"Participants using AboutFace~AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD."
11241419|NCT02486692|EG001|Reported Event|Phase II- Usual Care Condition|Education and Print materials only
11241420|NCT02486757|BG000|Baseline|Interventional|"estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days~micronized progesterone~transdermal estradiol"
11241421|NCT02486757|FG000|Participant Flow|Interventional|"estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days~micronized progesterone~transdermal estradiol"
11387713|NCT01373151|BG005|Baseline|Clazakizumab(200)+MTX|"BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11241422|NCT02486757|OG000|Outcome|Interventional|"estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days~micronized progesterone~transdermal estradiol"
11241423|NCT02486757|EG000|Reported Event|Interventional|"estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days~micronized progesterone~transdermal estradiol"
11241424|NCT02486796|BG000|Baseline|Immediate and Continuous Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241425|NCT02486796|BG001|Baseline|Delayed Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241426|NCT02486796|BG002|Baseline|Total|Total of all reporting groups
11241427|NCT02486796|FG000|Participant Flow|Immediate and Continuous Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241428|NCT02486796|FG001|Participant Flow|Delayed Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241429|NCT02486796|OG000|Outcome|Immediate and Continuous Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241430|NCT02486796|OG001|Outcome|Delayed Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241431|NCT02486796|EG000|Reported Event|Immediate and Continuous Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241432|NCT02486796|EG001|Reported Event|Delayed Dosing|"Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.~Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction.~Coenzyme Q10: Preparation of coenzyme Q10~Melatonin: Preparation of melatonin"
11241433|NCT02486939|BG000|Baseline|CHS-0214-02-RA|RA Participants
11241434|NCT02486939|BG001|Baseline|CHS-0214-04-PsO|PsO Participants
11241435|NCT02486939|BG002|Baseline|Total|Total of all reporting groups
11241436|NCT02486939|FG000|Participant Flow|CHS-0214-02 -RA|RA Participants
11241437|NCT02486939|FG001|Participant Flow|CHS-0214-04 - PsO|PsO Participants
11387714|NCT01373151|BG006|Baseline|ADA+MTX|"Adalimumab(ADA) + Methotrexate~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks"
11387715|NCT01373151|BG007|Baseline|Total|Total of all reporting groups
11387716|NCT01373151|FG000|Participant Flow|Placebo+MTX|"BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo~BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387717|NCT01373151|FG001|Participant Flow|Clazakizumab(25)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387718|NCT01373151|FG002|Participant Flow|Clazakizumab(100)|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387719|NCT01373151|FG003|Participant Flow|Clazakizumab(100)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387720|NCT01373151|FG004|Participant Flow|Clazakizumab(200)|"BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387721|NCT01373151|FG005|Participant Flow|Clazakizumab(200)+MTX|"BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387722|NCT01373151|FG006|Participant Flow|ADA+MTX|"Adalimumab(ADA) + Methotrexate~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks"
11387723|NCT01373151|OG000|Outcome|Placebo+MTX|"BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo~BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387724|NCT01373151|OG001|Outcome|Clazakizumab(25)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387725|NCT01373151|OG002|Outcome|Clazakizumab(100)|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387726|NCT01373151|OG003|Outcome|Clazakizumab(100)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387727|NCT01373151|OG004|Outcome|Clazakizumab(200)|"BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387728|NCT01373151|OG005|Outcome|Clazakizumab(200)+MTX|"BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
10850933|NCT03410992|BG001|Baseline|Bimekizumab 320 mg Q4W|Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11241438|NCT02486939|OG000|Outcome|CHS-0214-02 -RA|RA Participants
11241439|NCT02486939|OG000|Outcome|CHS-0214-04 - PsO|PsO Participants
11241440|NCT02486939|EG000|Reported Event|CHS-0214-02-RA|RA Participants
11387729|NCT01373151|OG006|Outcome|ADA+MTX|"Adalimumab(ADA) + Methotrexate~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks"
11387730|NCT01373151|EG000|Reported Event|Placebo+MTX|"BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo~BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387731|NCT01373151|EG001|Reported Event|Clazakizumab(25)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387732|NCT01373151|EG002|Reported Event|Clazakizumab(100)|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387733|NCT01373151|EG003|Reported Event|Clazakizumab(100)+MTX|"BMS-945429 + Methotrexate + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387734|NCT01373151|EG004|Reported Event|Clazakizumab(200)|"BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387735|NCT01373151|EG005|Reported Event|Clazakizumab(200)+MTX|"BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo~BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks~Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only~Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only~Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks"
11387736|NCT01373151|EG006|Reported Event|ADA+MTX|"Adalimumab(ADA) + Methotrexate~Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks~Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks"
11387737|NCT01328587|BG000|Baseline|Eltrombopag|Patients will receive Eltrombopag ( thrombopoietin receptor agonist) by mouth once a day.
11387738|NCT01328587|FG000|Participant Flow|Eltrombopag|Patients will receive Eltrombopag ( thrombopoietin receptor agonist) by mouth once a day.
11387739|NCT01328587|OG000|Outcome|Eltrombopag|"Eltrombopag will be administered for 16 to 20 weeks at a starting dose of 50mg/day (East Asian ancestry 25mg/day). The dose will decreased and increased (maximum dose 300mg/day) based on safety and response.~Eltrombopag: Eltrombopag will be administered for 16 to 20 weeks at a starting dose of 150mg/day (East Asian ancestry 75mg /day). The dose will decreased and increased (maximum dose 300mg/day) based on safety and response."
11387740|NCT01328587|EG000|Reported Event|Eltrombopag|Patients will receive Eltrombopag ( thrombopoietin receptor agonist) by mouth once a day.
11387741|NCT01285947|BG000|Baseline|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
11387742|NCT01285947|BG001|Baseline|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
11387743|NCT01285947|BG002|Baseline|Total|Total of all reporting groups
11387744|NCT01285947|FG000|Participant Flow|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
11387745|NCT01285947|FG001|Participant Flow|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
11387746|NCT01285947|OG000|Outcome|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
11387747|NCT01285947|OG001|Outcome|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
11387748|NCT01285947|EG000|Reported Event|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
11387749|NCT01285947|EG001|Reported Event|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
11387750|NCT01281644|BG000|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
11387751|NCT01281644|FG000|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
11387752|NCT01281644|OG000|Outcome|No Laser Treatment|
11387753|NCT01281644|OG001|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
11387754|NCT01281644|EG000|Reported Event|No Laser Treatment|
11387755|NCT01281644|EG001|Reported Event|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
11387756|NCT01274611|BG000|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
11387757|NCT01274611|FG000|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
11387758|NCT01274611|OG000|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
11387759|NCT01274611|OG001|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
11387760|NCT01274611|EG000|Reported Event|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
11387761|NCT01274611|EG001|Reported Event|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
10850934|NCT03410992|BG002|Baseline|Total Title|
11241441|NCT02486939|EG001|Reported Event|CHS-0214-04-PsO|PsO Participants
11387762|NCT00960297|BG000|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
11387763|NCT00960297|FG000|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
11387764|NCT00960297|OG000|Outcome|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
11387765|NCT00960297|EG000|Reported Event|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
11387766|NCT00910650|BG000|Baseline|F5 TCR Transgenic Cells|"F5 TCR transgenic cell adoptive transfer therapy~F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.~non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days"
11387767|NCT00910650|FG000|Participant Flow|F5 T-cell Receptor (TCR) Transgenic Cells|"F5 TCR transgenic cell adoptive transfer therapy~F5 TCR transgenic cells and Melanoma antigen recognized by T-cells (MART-1) peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose Interleukin-2 (IL-2) 500,000 IU/m2 s.c. twice daily for 14 days.~non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days"
11387768|NCT00910650|OG000|Outcome|F5 TCR Transgenic Cells|"F5 TCR transgenic cell adoptive transfer therapy~F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.~non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days"
11387769|NCT00910650|EG000|Reported Event|F5 TCR Transgenic Cells|"F5 TCR transgenic cell adoptive transfer therapy~F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.~non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days"
11387770|NCT00793169|BG000|Baseline|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
11387771|NCT00793169|FG000|Participant Flow|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
11387772|NCT00793169|OG000|Outcome|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
11387773|NCT00793169|EG000|Reported Event|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
11387774|NCT00703326|BG000|Baseline|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387775|NCT00703326|BG001|Baseline|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387776|NCT00703326|BG002|Baseline|Total|Total of all reporting groups
11387777|NCT00703326|FG000|Participant Flow|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387778|NCT00703326|FG001|Participant Flow|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387779|NCT00703326|OG000|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387780|NCT00703326|OG001|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387781|NCT00703326|OG001|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day~1 of each 21-day cycle."
11387782|NCT00703326|EG000|Reported Event|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387783|NCT00703326|EG001|Reported Event|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
11387784|NCT00602667|BG000|Baseline|Low-Risk Group|Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
11387785|NCT00602667|BG001|Baseline|Intermediate-Risk Group|Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
11387786|NCT00602667|BG002|Baseline|High-Risk Group|Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
11387787|NCT00602667|BG003|Baseline|Total|Total of all reporting groups
11387788|NCT00602667|FG000|Participant Flow|Low-Risk Group|Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
11387789|NCT00602667|FG001|Participant Flow|Intermediate-Risk Group|Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
11387790|NCT00602667|FG002|Participant Flow|High-Risk Group|Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
11387791|NCT00602667|OG000|Outcome|Low-Risk Group|Medulloblastoma patients <3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) [R0])
11387792|NCT00602667|OG001|Outcome|Intermediate-Risk Group|Medulloblastoma patients <3 years of age, M0, and either R0 resection with any other medullo histology other than DN/MBEN (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of >1 cm^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group High Risk
11387793|NCT00602667|OG002|Outcome|High-Risk Group|Medulloblastoma patients <3 years of age with evidence of metastatic disease
11387794|NCT00602667|OG000|Outcome|Low-risk SHH Patients|Sonic hedgehog (SHH) medulloblastoma subgroup patients in the low-risk group
11387795|NCT00602667|OG001|Outcome|Intermediate-risk SHH Patients|Sonic hedgehog (SHH) medulloblastoma subgroup patients in the intermediate-risk group
11387796|NCT00602667|OG002|Outcome|High-risk SHH Patients|Sonic hedgehog (SHH) medulloblastoma subgroup patients in the high-risk group
11387797|NCT00602667|OG003|Outcome|Low-risk Group 3 Patients|Group 3 (G3) medulloblastoma subgroup patients in the low-risk group
11387798|NCT00602667|OG004|Outcome|Intermediate-risk Group 3 Patients|Group 3 medulloblastoma subgroup patients in the intermediate-risk group
11387799|NCT00602667|OG005|Outcome|High-risk Group 3 Patients|Group 3 medulloblastoma subgroup patients in the high-risk group
11387800|NCT00602667|OG006|Outcome|Low-risk Group 4 Patients|Group 4 (G4) medulloblastoma subgroup patients in the low-risk group
11387801|NCT00602667|OG007|Outcome|Intermediate-risk Group 4 Patients|Group 4 (G4) medulloblastoma subgroup patients in the intermediate-risk group
11387802|NCT00602667|OG008|Outcome|High-risk Group 4 Patients|Group 4 medulloblastoma subgroup patients in the high-risk group
11387803|NCT00602667|OG000|Outcome|Low-Risk Group|Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
11387804|NCT00602667|OG001|Outcome|Intermediate-Risk Group|Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
11387805|NCT00602667|OG002|Outcome|High-Risk Group|Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
11197347|NCT02170649|FG000|Participant Flow|BIA 2-093 (Fasting & Fed)|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
11197348|NCT02170649|OG000|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
11387806|NCT00602667|OG000|Outcome|SJYC07 Low-risk Medulloblastoma Patients|Medulloblastoma patients <3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) [R0])
11197349|NCT02170649|EG000|Reported Event|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
11387807|NCT00602667|OG001|Outcome|SJYC07 Intermediate-risk Medulloblastoma Patients|SJYC07 medulloblastoma patients <3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of >1 cm^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group
11387808|NCT00602667|OG002|Outcome|SJYC07 High-risk Medulloblastoma Patients|SJYC07 medulloblastoma patients <3 years of age with evidence of metastatic disease
11387809|NCT00602667|OG000|Outcome|Intermediate-Risk Group|Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
11387810|NCT00602667|OG001|Outcome|High-Risk Group|Patients with central nervous system (CNS) metastatic disease
11387811|NCT00602667|OG000|Outcome|High-Risk Group|Patients with central nervous system (CNS) metastatic disease
11387812|NCT00602667|OG000|Outcome|Low-Risk Group|Patients <3 years of age with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
11387813|NCT00602667|OG001|Outcome|Intermediate-Risk Group|Patients <3 years of age with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
11387814|NCT00602667|OG002|Outcome|High-Risk Group|Patients <3 years of age with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy
11387815|NCT00602667|OG000|Outcome|Intermediate Risk Group|Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease
11387816|NCT00602667|OG000|Outcome|Low-Risk Group|Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
11387817|NCT00602667|OG001|Outcome|Intermediate-Risk Group|Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
11387818|NCT00602667|OG002|Outcome|High-Risk Group|Patients with central nervous system (CNS) metastatic disease
11387819|NCT00602667|OG000|Outcome|Intermediate-risk Patients Who Received Focal Radiation|Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a surgical gross total resection (GTR), other histologic diagnoses with no metastatic disease who received induction chemotherapy and intermediate-risk therapy that included focal radiation.
11387820|NCT00602667|OG000|Outcome|Intermediate-risk Patients Who Received Focal Radiation|Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease who received induction chemotherapy and intermediate-risk therapy that included focal radiation.
11387821|NCT00602667|EG000|Reported Event|Low-Risk Group|Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
11387822|NCT00602667|EG001|Reported Event|Intermediate-Risk Group|Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
11387823|NCT00602667|EG002|Reported Event|High-Risk Group|Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
11387824|NCT00535990|BG000|Baseline|Surgical Intervention|All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
11387825|NCT00535990|FG000|Participant Flow|Surgical Intervention|All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
11387826|NCT00535990|OG000|Outcome|Surgical Intervention|All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
11387827|NCT00535990|EG000|Reported Event|Surgical Intervention|All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
11387828|NCT00472186|BG000|Baseline|1: Post-operative Administration of Lansoprazole|Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
11387829|NCT00472186|BG001|Baseline|2: Placebo|Placebo: Placebo will also be administered based on weight.
11387830|NCT00472186|BG002|Baseline|Total|Total of all reporting groups
11387831|NCT00472186|FG000|Participant Flow|1: Post-operative Administration of Lansoprazole|Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
11387832|NCT00472186|FG001|Participant Flow|2: Placebo|Placebo: Placebo will also be administered based on weight.
11387833|NCT00472186|OG000|Outcome|1: Post-operative Administration of Lansoprazole|Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
11387834|NCT00472186|OG001|Outcome|2: Placebo|Placebo: Placebo will also be administered based on weight.
11387835|NCT00472186|OG000|Outcome|Lansoprazole|Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
11387836|NCT00472186|OG001|Outcome|Placebo|Placebo: Placebo will also be administered based on weight.
11387837|NCT00472186|EG000|Reported Event|1: Post-operative Administration of Lansoprazole|Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
11387838|NCT00472186|EG001|Reported Event|2: Placebo|Placebo: Placebo will also be administered based on weight.
11197350|NCT02170662|BG000|Baseline|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
11387839|NCT03996876|BG000|Baseline|Threat ABM Training|All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received.
11387840|NCT03996876|BG001|Baseline|Neutral Attention Training|All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received.
11387841|NCT03996876|BG002|Baseline|Total|Total of all reporting groups
11387842|NCT03996876|FG000|Participant Flow|Threat ABM Training|"Attention Bias Modification Training with threatening words~RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile app will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user."
11387843|NCT03996876|FG001|Participant Flow|Neutral Attention Training|"Non-active version of ABM Training~RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words."
11387844|NCT03996876|OG000|Outcome|Threat ABM Training|"Attention Bias Modification Training with threatening words~RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile app will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user."
11387845|NCT03996876|OG001|Outcome|Neutral Attention Training|"Non-active version of ABM Training~RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words."
11387846|NCT03996876|OG000|Outcome|Threat ABM Training|All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received.
11387847|NCT03996876|EG000|Reported Event|Threat ABM Training|"Attention Bias Modification Training with threatening words~RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile app will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user."
11241442|NCT02486952|BG000|Baseline|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11387848|NCT03996876|EG001|Reported Event|Neutral Attention Training|"Non-active version of ABM Training~RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words."
11387849|NCT03589976|BG000|Baseline|Sirolimus|"2 mg/day (one 2-mg tablet/day). The dose of sirolimus will be adjusted throughout the trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose of sirolimus will be6 mg/day (three 2-mg tablets/day).~Sirolimus 2 MG: Dose will be adjusted throughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose will be 6mg/day."
11387850|NCT03589976|BG001|Baseline|Placebo|"Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.~Placebo: Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial."
11387851|NCT03589976|BG002|Baseline|Total|Total of all reporting groups
11387852|NCT03589976|FG000|Participant Flow|Sirolimus|"2 mg/day (one 2-mg tablet/day). The dose of sirolimus will be adjusted throughout the trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose of sirolimus will be6 mg/day (three 2-mg tablets/day).~Sirolimus 2 MG: Dose will be adjusted throughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose will be 6mg/day."
11387853|NCT03589976|FG001|Participant Flow|Placebo|"Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.~Placebo: Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial."
11387854|NCT03589976|OG000|Outcome|Sirolimus|"2 mg/day (one 2-mg tablet/day). The dose of sirolimus will be adjusted throughout the trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose of sirolimus will be6 mg/day (three 2-mg tablets/day).~Sirolimus 2 MG: Dose will be adjusted throughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose will be 6mg/day."
11387855|NCT03589976|OG001|Outcome|Placebo|"Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.~Placebo: Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial."
11387856|NCT03589976|EG000|Reported Event|Sirolimus|"2 mg/day (one 2-mg tablet/day). The dose of sirolimus will be adjusted throughout the trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose of sirolimus will be6 mg/day (three 2-mg tablets/day).~Sirolimus 2 MG: Dose will be adjusted throughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose will be 6mg/day."
11387857|NCT03589976|EG001|Reported Event|Placebo|"Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.~Placebo: Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial."
11387858|NCT03490227|BG000|Baseline|All Participants|This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
11387859|NCT03490227|FG000|Participant Flow|All Participants|This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
11387860|NCT03490227|OG000|Outcome|All Participants|This is an observational study where all participants did DXA once in order to assess infant body composition.
11387861|NCT03490227|OG000|Outcome|All Participants|This is an observational study where all participants did MRI twice in order to assess infant brown adipose tissue volume.
11387862|NCT03490227|OG000|Outcome|All Participants|This is an observational study where all participants did MRI twice in order to assess the reliability of measuring brown adipose tissue in infants.
11387863|NCT03490227|EG000|Reported Event|All Participants|This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
11387864|NCT03401190|BG000|Baseline|Low Dose Group|Consisted of 8 patients, 5 female and 3 male, who were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours.
11387865|NCT03401190|BG001|Baseline|High Dose Group|Consisted of 6 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
11387866|NCT03401190|BG002|Baseline|Standard of Care Group|Consisted of 7 patients, 4 female and 3 male, who received local standard of care.
11387867|NCT03401190|BG003|Baseline|Total|Total of all reporting groups
10800123|NCT02527434|BG002|Baseline|PDAC Cohort|"Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
10800124|NCT02527434|BG003|Baseline|Total|Total of all reporting groups
10850935|NCT03410992|FG000|Participant Flow|Placebo|Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11387868|NCT03401190|FG000|Participant Flow|Low Dose Group|Patients were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours.
11387869|NCT03401190|FG001|Participant Flow|High Dose Group|Patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
11387870|NCT03401190|FG002|Participant Flow|Standard of Care Group|Patients were randomized to receive local standard of care.
11387871|NCT03401190|OG000|Outcome|Low Dose Group + SC|Consisted of 8 patients, 5 female and 3 male, who were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours. All patients were also to receive standard of care (SC).
11387872|NCT03401190|OG001|Outcome|High Dose Group + SC|Consisted of 6 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. All patients were also to receive standard of care (SC).
11387873|NCT03401190|OG002|Outcome|Standard of Care Group (SC)|Consisted of 7 patients, 4 female and 3 male, who received local standard of care.
11387874|NCT03401190|OG001|Outcome|High Dose Group + SC|Consisted of 5 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. All patients were also to receive standard of care (SC).
11387875|NCT03401190|OG002|Outcome|Standard of Care (SC)|Consisted of 7 patients, 4 female and 3 male, who received local standard of care.
11387876|NCT03401190|OG000|Outcome|Low Dose Group + SC|Consisted of 8 patients, 5 female and 3 male, who were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours. All patients also were to receive standard of care (SC).
11387877|NCT03401190|OG001|Outcome|High Dose Group + SC|Consisted of 6 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. All patients also were to receive standard of care (SC).
11387878|NCT03401190|EG000|Reported Event|Low Dose Group|Consisted of 8 patients, 5 female and 3 male, who were randomized to receive CM4620-IE 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. All doses of CM4620-IE were administered intravenously (IV) over 4 hours.
11387879|NCT03401190|EG001|Reported Event|High Dose Group|Consisted of 6 male patients were randomized to receive CM4620-IE 2.08 mg/kg on Days 1 and 2, and 1.6 mg/kg on Days 3-4. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
11387880|NCT03401190|EG002|Reported Event|Standard of Care Group|Consisted of 7 patients, 4 female and 3 male, who received local standard of care.
11387881|NCT03392753|BG000|Baseline|Mechanochemical Ablation (MOCA)|"Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).~Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)"
11387882|NCT03392753|BG001|Baseline|Cyanoacrylate Adhesive (CAE)|"Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).~Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)"
11387883|NCT03392753|BG002|Baseline|Total|Total of all reporting groups
11387884|NCT03392753|FG000|Participant Flow|Mechanochemical Ablation (MOCA)|"Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).~Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)"
11387885|NCT03392753|FG001|Participant Flow|Cyanoacrylate Adhesive (CAE)|"Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).~Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)"
11387886|NCT03392753|OG000|Outcome|Mechanochemical Ablation (MOCA)|"Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).~Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)"
11387887|NCT03392753|OG001|Outcome|Cyanoacrylate Adhesive (CAE)|"Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).~Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)"
11387888|NCT03392753|EG000|Reported Event|Mechanochemical Ablation (MOCA)|"Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).~Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)"
11387889|NCT03392753|EG001|Reported Event|Cyanoacrylate Adhesive (CAE)|"Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).~Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)"
10800125|NCT02527434|FG000|Participant Flow|UBC Cohort|"Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via intravenous (IV) infusion at a dose of 750 milligrams (mg) once every 4 weeks (q4w) for 7 doses (cycles), then every 12 weeks (q12w) for 2 additional cycles, for up to a total of 12 months or until confirmed progressive disease (PD).~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive MEDI4736 (durvalumab) + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
11387890|NCT03212963|BG000|Baseline|Halobetasol Lotion Treatment Arm|"All subjects will receive Halobetasol Topical Lotion, 0.05%.~Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis."
11387891|NCT03212963|FG000|Participant Flow|Halobetasol Lotion Treatment Arm|"All subjects will receive Halobetasol Topical Lotion, 0.05%.~Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis."
11387892|NCT03212963|OG000|Outcome|Halobetasol Lotion Treatment Arm|"All subjects will receive Halobetasol Topical Lotion, 0.05%.~Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis."
11387893|NCT03212963|EG000|Reported Event|Halobetasol Lotion Treatment Arm|"All subjects will receive Halobetasol Topical Lotion, 0.05%.~Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis."
11387894|NCT03135262|BG000|Baseline|Dose-Escalation DLBCL and FL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387895|NCT03135262|BG001|Baseline|Dose-Escalation DLBCL and FL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387896|NCT03135262|BG002|Baseline|Dose Escaltion DLBCL and FL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387897|NCT03135262|BG003|Baseline|Dose Escalation DLBCL and FL Cohort 3|Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
11387898|NCT03135262|BG004|Baseline|Not Defined for DLBCL or FL Subgroups Cohort 3|Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
11387899|NCT03135262|BG005|Baseline|Total|Total of all reporting groups
11387900|NCT03135262|FG000|Participant Flow|Dose Escalation DLBCL and FL Safety Cohort|Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387901|NCT03135262|FG001|Participant Flow|Dose Escalation DLBCL and FL Cohort 1|Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387902|NCT03135262|FG002|Participant Flow|Dose Escalation DLBCL and FL Cohort 2|Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387903|NCT03135262|FG003|Participant Flow|Dose Escalation DLBCL and FL Cohort 3|Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
11387904|NCT03135262|FG004|Participant Flow|Not Defined for DLBCL or FL Subgroups Cohort 3|Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
11387905|NCT03135262|OG000|Outcome|Dose Escalation DLBCL and FL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387906|NCT03135262|OG001|Outcome|Dose Escaltion DLBCL and FL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387907|NCT03135262|OG002|Outcome|Dose Escaltion DLBCL and FL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387908|NCT03135262|OG003|Outcome|Dose Escalation DLBCL and FL Cohort 3|Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
11387909|NCT03135262|OG004|Outcome|Not Defined for DLBCL or FL Subgroups Cohort 3|Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
11387910|NCT03135262|OG001|Outcome|Dose Escalation DLBCL and FL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387911|NCT03135262|OG000|Outcome|Dose Escaltion DLBCL and FL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387912|NCT03135262|OG002|Outcome|Dose Escalation DLBCL and FL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387913|NCT03135262|OG000|Outcome|Dose-Escalation DLBCL and FL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387914|NCT03135262|OG001|Outcome|Dose-Escalation DLBCL and FL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387915|NCT03135262|OG002|Outcome|Dose Escalation DLBCL and FL Cohort 2|Idasanutlin 150 mg + venetoclax 400 mg + obinutuzumab 1000 mg
11387916|NCT03135262|OG000|Outcome|Dose Escalation FL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387917|NCT03135262|OG001|Outcome|Dose Escalation FL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387918|NCT03135262|OG002|Outcome|Dose Escalation FL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387919|NCT03135262|OG003|Outcome|Dose Escalation FL Cohort 3|Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
11387920|NCT03135262|OG000|Outcome|Dose Escalation DLBCL Safety Cohort 2|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387921|NCT03135262|OG001|Outcome|Dose Escalation DLBCL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387922|NCT03135262|OG002|Outcome|Dose Escaltion DLBCL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387923|NCT03135262|OG003|Outcome|Dose Escalation DLBCL Cohort 3|Idasanutlin 100 mg + venetoclax 400 mg + obinutuzumab 1000 mg
11387924|NCT03135262|OG000|Outcome|Dose Escaltion DLBCL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387925|NCT03135262|OG000|Outcome|Dose Escalation DLBCL Safety Cohort|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387926|NCT03135262|OG001|Outcome|Dose Escaltion DLBCL Cohort 1|Idasanutlin 100 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387927|NCT03135262|OG002|Outcome|Dose Escalation DLBCL Cohort 2|Idasanutlin 150 mg + venetoclax 200 mg + obinutuzumab 1000 mg
11387928|NCT03135262|EG000|Reported Event|Dose Escalation DLBCL and FL Safety Cohort|Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387929|NCT03135262|EG001|Reported Event|Dose Escalation DLBCL and FL Cohort 1|Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387930|NCT03135262|EG002|Reported Event|Dose Escalation DLBCL and FL Cohort 2|Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
11387931|NCT03135262|EG003|Reported Event|Dose Escalation DLBCL and FL Cohort 3|Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
11387932|NCT03135262|EG004|Reported Event|Not Defined for DLBCL or FL Subgroups Cohort 3|Idasanutlin 100 mg+ Venetoclax 200mg + obinutuzumab 1000 mg
11387933|NCT03104075|BG000|Baseline|Prevnar 13|"Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care.~Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23"
11387934|NCT03104075|BG001|Baseline|Pneumovax 23|"Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care.~Pneumococcal Vaccine Polyvalent: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13"
11387935|NCT03104075|BG002|Baseline|Total|Total of all reporting groups
11387936|NCT03104075|FG000|Participant Flow|Prevnar 13|"Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care.~Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23"
11387937|NCT03104075|FG001|Participant Flow|Pneumovax 23|"Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care.~Pneumococcal Vaccine Polyvalent: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13"
11387938|NCT03104075|OG000|Outcome|Prevnar 13|"Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care. [Data analyzed and shown below for the first vaccine i.e. Prevnar 13]~Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23. [Second vaccine i.e. Pneumovax 23 administered at study endpoint (Visit 7), no further data collected post-second vaccination]"
11387939|NCT03104075|OG001|Outcome|Pneumovax 23|"Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care. [Data analyzed and shown below for the first vaccine i.e. Pneumovax 23]~Pneumococcal Vaccine Polyvalent: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13. [Second vaccine i.e. Prevnar 13 administered at study endpoint (Visit 7), no further data collected post-second vaccination]"
11387940|NCT03104075|OG001|Outcome|Pneumovax 23|Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care. [Data analyzed and shown below for the first vaccine i.e. Pneumovax 23] Pneumococcal Vaccine Polyvalent: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13. [Second vaccine i.e. Prevnar 13 administered at study endpoint (Visit 7), no further data collected post-second vaccination]
11387941|NCT03104075|EG000|Reported Event|Prevnar 13|Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care.
11387942|NCT03104075|EG001|Reported Event|Pneumovax 23|Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care.
11387943|NCT03038087|BG000|Baseline|SENSE Device Monitoring in ICH Patients|"The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:~A molded plastic headpiece containing the antenna array, and~A processing control unit that contains:~The driving electronics for the array;~A spectrum analyzer coupled with a computer; and,~The operating software that controls the device function and data acquisition, processing and archiving.~For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.~The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device."
11387944|NCT03038087|FG000|Participant Flow|SENSE Device Monitoring in ICH Patients|"The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:~A molded plastic headpiece containing the antenna array, and~A processing control unit that contains:~The driving electronics for the array;~A spectrum analyzer coupled with a computer; and,~The operating software that controls the device function and data acquisition, processing and archiving.~For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.~The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device."
11387945|NCT03038087|OG000|Outcome|Subjects Who Experienced Serious Device-related Adverse Events or Seizure.|The number of subjects who experienced a device related serious AE and/or seizures will be tabulated and summarized.
11387946|NCT03038087|OG000|Outcome|ICH Patients With Hemorrhage Expansion|The primary aim was to determine determine the ability of the SENSE device to detect a clinically significant (>= 3 ml) hemorrhage expansion in ICH patients. ICH volume was determined by CT measurements at 0, 12, and up to 72 hours (if available).
11197351|NCT02170662|BG001|Baseline|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
11387947|NCT03038087|OG000|Outcome|SENSE Device Monitoring in ICH Patients|"The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:~A molded plastic headpiece containing the antenna array, and~A processing control unit that contains:~The driving electronics for the array;~A spectrum analyzer coupled with a computer; and,~The operating software that controls the device function and data acquisition, processing and archiving.~For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.~The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device."
11387948|NCT03038087|EG000|Reported Event|SENSE Device Monitoring in ICH Patients|"The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:~A molded plastic headpiece containing the antenna array, and~A processing control unit that contains:~The driving electronics for the array;~A spectrum analyzer coupled with a computer; and,~The operating software that controls the device function and data acquisition, processing and archiving.~For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.~The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device."
11387949|NCT02880540|BG000|Baseline|Control Group|"Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor~Fentanyl~Morphine"
11387950|NCT02880540|BG001|Baseline|Dexmedetomidine Treated|"Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery~Dexmedetomidine"
11387951|NCT02880540|BG002|Baseline|Total|Total of all reporting groups
11387952|NCT02880540|FG000|Participant Flow|Control Group|"Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor~Fentanyl~Morphine"
11387953|NCT02880540|FG001|Participant Flow|Dexmedetomidine Treated|"Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery~Dexmedetomidine"
11387954|NCT02880540|OG000|Outcome|Control Group|"Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor~Fentanyl~Morphine"
11387955|NCT02880540|OG001|Outcome|Dexmedetomidine Treated|"Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery~Dexmedetomidine"
11387956|NCT02880540|EG000|Reported Event|Control Group|"Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor~Fentanyl~Morphine"
11387957|NCT02880540|EG001|Reported Event|Dexmedetomidine Treated|"Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery~Dexmedetomidine"
11387958|NCT02740972|BG000|Baseline|NS-065/NCNP-01 40mg/kg|Patients with confirmed DMD with genetic deletions amenable to exon 53 skipping will be administered an intravenous infusion of NS-065/NCNP-01 40mg/kg once a week for 24 weeks
11387959|NCT02740972|BG001|Baseline|NS-065/NCNP-01 80mg/kg|Patients with confirmed DMD with genetic deletions amenable to exon 53 skipping will be administered an intravenous infusion of NS-065/NCNP-01 80mg/kg once a week for 24 weeks
11387960|NCT02740972|BG002|Baseline|Total|Total of all reporting groups
11387961|NCT02740972|FG000|Participant Flow|Placebo (Period 1)|4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4
11387962|NCT02740972|FG001|Participant Flow|NS-065/NCNP-01 40mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4
11197352|NCT02170662|BG002|Baseline|Total|Total of all reporting groups
11197353|NCT02170662|FG000|Participant Flow|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
11197354|NCT02170662|FG001|Participant Flow|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
11197355|NCT02170662|OG000|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
11387963|NCT02740972|FG002|Participant Flow|NS-065/NCNP-01 80mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4
11387964|NCT02740972|FG003|Participant Flow|NS-065/NCNP-01 40mg/kg (Period 2)|20-week Open-label treatment period (Period 2) Week 5 - Week 24
11387965|NCT02740972|FG004|Participant Flow|NS-065/NCNP-01 80mg/kg (Period 2)|20-week Open-label treatment period (Period 2) Week 5 - Week 24
11387966|NCT02740972|OG000|Outcome|Placebo (Period 1)|"4-week Double-blinded placebo-controlled period (Period 1)~Two patients in each of the dose groups will be administered placebo as an intravenous infusion once a week for 4 weeks followed by 20 weeks of open label treatment"
11387967|NCT02740972|OG001|Outcome|NS-065/NCNP-01 40mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1)
11387968|NCT02740972|OG002|Outcome|NS-065/NCNP-01 80mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1)
11387969|NCT02740972|OG003|Outcome|NS-065/NCNP-01 40mg/kg (Period 2)|20-week Open-label treatment period (Period 2)
11387970|NCT02740972|OG004|Outcome|NS-065/NCNP-01 80mg/kg (Period 2)|20-week Open-label treatment period (Period 2)
11387971|NCT02740972|OG005|Outcome|Total|Total of all reporting groups
11387972|NCT02740972|OG000|Outcome|NS-065/NCNP-01 40mg/kg|NS-065/NCNP-01 40mg/kg dose once a week for 20-24 weeks
11387973|NCT02740972|OG001|Outcome|NS-065/NCNP-01 80mg/kg|NS-065/NCNP-01 80mg/kg dose once a week for 20-24 weeks
11338328|NCT03606460|FG001|Participant Flow|Cohort 2|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
11338329|NCT03606460|OG000|Outcome|Cohort 1|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who have already received one or two doses of ocrelizumab according to the approved infusion protocol and have reported no serious infusion-related reactions (IRRs) will be enrolled. They will then receive the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 is administered at Week 24, Dose 3 is administered at Week 48 after initial infusion.
11338330|NCT03606460|OG001|Outcome|Cohort 2|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
11387974|NCT02740972|OG002|Outcome|Total NS-065/NCNP-01 Group|Of the 16 patients randomized, all patients received treatment with NS-065/NCNP-01 and all patients completed treatment with NS-065/NCNP-01.
11387975|NCT02740972|EG000|Reported Event|Placebo (Period 1)|"4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4~Two patients in each of the dose groups will be administered placebo as an intravenous infusion once a week for 4 weeks followed by 20 weeks of open label treatment"
11387976|NCT02740972|EG001|Reported Event|NS-065/NCNP-01 40mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4
11387977|NCT02740972|EG002|Reported Event|NS-065/NCNP-01 80mg/kg (Period 1)|4-week Double-blinded placebo-controlled period (Period 1) Week 0 - Week 4
11387978|NCT02740972|EG003|Reported Event|NS-065/NCNP-01 40mg/kg (Period 2)|20-week Open-label treatment period (Period 2) Week 5 - Week 24
11387979|NCT02740972|EG004|Reported Event|NS-065/NCNP-01 80mg/kg (Period 2)|20-week Open-label treatment period (Period 2) Week 5 - Week 24
11387980|NCT02740972|EG005|Reported Event|Total|Total of all reporting groups
11338331|NCT03606460|OG000|Outcome|Cohort 2|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
11338332|NCT03606460|EG000|Reported Event|Cohort 1|This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion.
11338333|NCT03606460|EG001|Reported Event|Cohort 2|This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
11338334|NCT03607539|BG000|Baseline|Sintilimab Combination|Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
11338335|NCT03607539|BG001|Baseline|Placebo Combination|Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
11338336|NCT03607539|BG002|Baseline|Total|Total of all reporting groups
11338337|NCT03607539|FG000|Participant Flow|Sintilimab Combination|Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
11338338|NCT03607539|FG001|Participant Flow|Placebo Combination|Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
11338339|NCT03607539|OG000|Outcome|Sintilimab Combination|Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
11338340|NCT03607539|OG001|Outcome|Placebo Combination|Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
11338341|NCT03607539|EG000|Reported Event|Sintilimab Combination|Sintilimab 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then sintilimab 200mg, pemetrexed 500mg/m2 IV infusion q3w
11338342|NCT03607539|EG001|Reported Event|Placebo Combination|Placebo 200mg, pemetrexed 500mg/m2, cisplatin 75mg/m2 or carboplatin AUC 5 IV infusion q3w for 4 cycles, then placebo, pemetrexed 500mg/m2 IV infusion q3w
11387981|NCT02662985|BG000|Baseline|Group 1 - Secukinumab (150 mg + 300 mg)|"In Treatment Period-1:~Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.~In Treatment Period-2:~Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24 (although primary outcome was to week 12 only)~In Treatment Period 3 (extension period):~the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52"
11387982|NCT02662985|BG001|Baseline|Group 2 - Placebo/Secukinumab (150 mg + 300 mg)|"In Treatment Period-1:~Patients received placebo at baseline and same time points as secukinumab until Week 8.~In Treatment Period-2:~Patients commenced open-label secukinumab 150 or 300 mg every 4 weeks from Week 12, as follows, based on their severity of skin disease at Week 12~In Treatment Period-3:~Open-label secukinumab continued to be assigned to patients"
11387983|NCT02662985|BG002|Baseline|Total|Total of all reporting groups
11387984|NCT02662985|FG000|Participant Flow|Group 1 - Secukinumab (150 mg + 300 mg)|"In Treatment Period-1:~Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.~In Treatment Period-2:~Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24 (although primary outcome was to week 12 only)~In Treatment Period 3 (extension period):~the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52"
11387985|NCT02662985|FG001|Participant Flow|Group 2 - Placebo/Secukinumab|"In Treatment Period-1:~Patients received placebo at baseline and same time points as secukinumab until Week 8.~In Treatment Period-2:~Patients commenced open-label 150 or 300 mg secukinumab every 4 weeks from Week 12, as follows, based on their severity of skin disease at Week 12~In Treatment Period-3:~Open-label secukinumab continued to be assigned to patients"
11387986|NCT02662985|OG000|Outcome|Group 1 - Secukinumab (150 mg + 300 mg)|"In Treatment Period-1:~Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.~In Treatment Period-2:~Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24 (although primary outcome was to week 12 only)~In Treatment Period 3 (extension period):~the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52"
11387987|NCT02662985|OG001|Outcome|Group 2 - Placebo/Secukinumab|"In Treatment Period-1:~Patients received placebo at baseline and same time points as secukinumab until Week 8.~In Treatment Period-2:~Patients commenced open-label 150 or 300 mg secukinumab every 4 weeks from Week 12, as follows, based on their severity of skin disease at Week 12~In Treatment Period-3:~Open-label secukinumab continued to be assigned to patients"
11387988|NCT02662985|EG000|Reported Event|Treatment Group 1 - Secukinumab (150+300 mg)|"In Treatment Period-1:~Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.~In Treatment Period-2:~Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24 (although primary outcome was to week 12 only)~In Treatment Period 3 (extension period):~the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52"
11387989|NCT02662985|EG001|Reported Event|Treatnent Group 2 - Placebo/Secukinumab|"In Treatment Period-1:~Patients received placebo at baseline and same time points as secukinumab until Week 8.~In Treatment Period-2:~Patients commenced open-label 150 or 300 mg secukinumab every 4 weeks from Week 12, as follows, based on their severity of skin disease at Week 12~In Treatment Period-3:~Open-label secukinumab continued to be assigned to patients"
11387990|NCT02606461|BG000|Baseline|Phase 2 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 milligram (mg) selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11387991|NCT02606461|BG001|Baseline|Phase 2 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11387992|NCT02606461|BG002|Baseline|Phase 3 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 38 months until PD.
11387993|NCT02606461|BG003|Baseline|Phase 3 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 14 months until PD or development of unacceptable toxicity.
11387994|NCT02606461|BG004|Baseline|Total|Total of all reporting groups
11197356|NCT02170662|OG001|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
11387995|NCT02606461|FG000|Participant Flow|Phase 2 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11387996|NCT02606461|FG001|Participant Flow|Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.
11387997|NCT02606461|FG002|Participant Flow|Phase 3 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 38 months until PD.
11387998|NCT02606461|FG003|Participant Flow|Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 14 months until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.
11387999|NCT02606461|OG000|Outcome|Phase 3 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 38 months until PD.
11388000|NCT02606461|OG001|Outcome|Phase 3 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 14 months until PD or development of unacceptable toxicity.
10965824|NCT00884221|BG001|Baseline|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
10965825|NCT00884221|BG002|Baseline|Total|Total of all reporting groups
10965826|NCT00884221|FG000|Participant Flow|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
10965827|NCT00884221|FG001|Participant Flow|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
11197357|NCT02170662|EG000|Reported Event|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
11197358|NCT02170662|EG001|Reported Event|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
11388001|NCT02606461|OG000|Outcome|Phase 2 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 milligram (mg) selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11388002|NCT02606461|OG001|Outcome|Phase 2 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11388003|NCT02606461|OG000|Outcome|Phase 2 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11388004|NCT02606461|EG000|Reported Event|Phase 2 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11388005|NCT02606461|EG001|Reported Event|Phase 2 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 13 months until PD.
11388006|NCT02606461|EG002|Reported Event|Phase 3 Double-blinded: Selinexor|Participants received a fixed blinding dose of 60 mg selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 38 months until PD.
11388007|NCT02606461|EG003|Reported Event|Phase 3 Double-blinded: Placebo|Participants received a fixed blinding dose of placebo matched to selinexor twice weekly on Day 1 and 3 during each 6 Week cycle (42 days) up to 14 months until PD or development of unacceptable toxicity.
11388008|NCT02606461|EG004|Reported Event|Phase 2 Open-label: Selinexor|Participants received open-label selinexor 60 mg twice-weekly during Weeks 1-6 of each 6-week cycle (42-day), based on the decision by Investigator in collaboration with the sponsor, on the clinical judgment if the participants derive benefit from continued treatment with selinexor.
11388009|NCT02606461|EG005|Reported Event|Phase 3: Open-label: Selinexor|Participants received open-label selinexor 60 mg twice-weekly during Weeks 1-6 of each 6-week cycle (42-day), based on the decision by Investigator in collaboration with the sponsor, on the clinical judgment if the participants derive benefit from continued treatment with selinexor.
11388010|NCT02536339|BG000|Baseline|Pertuzumab + Trastuzumab|Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.
11388011|NCT02536339|FG000|Participant Flow|Pertuzumab + Trastuzumab|Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.
10803930|NCT01049035|OG001|Outcome|Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11197359|NCT02170688|BG000|Baseline|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
11338343|NCT03607682|BG000|Baseline|Prevention (TTF Therapy, NovoTTF-200A Device)|"Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy~NovoTTF-200A Device: Undergo TTF therapy~Quality-of-Life Assessment: Ancillary studies"
11338344|NCT03607682|FG000|Participant Flow|Prevention (TTF Therapy, NovoTTF-200A Device)|"Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy~NovoTTF-200A Device: Undergo TTF therapy~Quality-of-Life Assessment: Ancillary studies"
11338345|NCT03607682|OG000|Outcome|Prevention (TTF Therapy, NovoTTF-200A Device)|"Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy~NovoTTF-200A Device: Undergo TTF therapy~Quality-of-Life Assessment: Ancillary studies"
11338346|NCT03607682|EG000|Reported Event|Prevention (TTF Therapy, NovoTTF-200A Device)|"Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy~NovoTTF-200A Device: Undergo TTF therapy~Quality-of-Life Assessment: Ancillary studies"
11338347|NCT03607695|BG000|Baseline|Gait Training|"1 hour walking exercise on a treadmill~Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality"
11338348|NCT03607695|FG000|Participant Flow|Gait Training|"1 hour walking exercise on a treadmill~Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality"
11338349|NCT03607695|OG000|Outcome|Gait Training|"1 hour walking exercise on a treadmill~Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality"
11338350|NCT03607695|EG000|Reported Event|Gait Training|"1 hour walking exercise on a treadmill~Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality"
11338351|NCT03608488|BG000|Baseline|Vitamin D<10 ng/ml; Vitamin D Replacement|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks
11338352|NCT03608488|BG001|Baseline|Vitamin D<10 ng/ml; Exercise|Exercise: Core stability, balance exercises
11338353|NCT03608488|BG002|Baseline|Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises
11338354|NCT03608488|BG003|Baseline|Vitamin D>30ng/ml; Exercise|Exercise: Core stability, balance exercises
11338355|NCT03608488|BG004|Baseline|Total|Total of all reporting groups
11338356|NCT03608488|FG000|Participant Flow|Vitamin D<10 ng/ml; Vitamin D Replacement|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks
11338357|NCT03608488|FG001|Participant Flow|Vitamin D<10 ng/ml; Exercise|Exercise: Core stability, balance exercises
11338358|NCT03608488|FG002|Participant Flow|Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises
11338359|NCT03608488|FG003|Participant Flow|Vitamin D>30ng/ml; Exercise|Exercise: Core stability, balance exercises
11338360|NCT03608488|OG000|Outcome|Vitamin D<10 ng/ml; Vitamin D Replacement|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks
11338361|NCT03608488|OG001|Outcome|Vitamin D<10 ng/ml; Exercise|Exercise: Core stability, balance exercises
11338362|NCT03608488|OG002|Outcome|Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises
11338363|NCT03608488|OG003|Outcome|Vitamin D>30ng/ml; Exercise|Exercise: Core stability, balance exercises
11338364|NCT03608488|EG000|Reported Event|Vitamin D<10 ng/ml; Vitamin D Replacement|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks
11338365|NCT03608488|EG001|Reported Event|Vitamin D<10 ng/ml; Exercise|Exercise: Core stability, balance exercises
11338366|NCT03608488|EG002|Reported Event|Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise|Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises
11338367|NCT03608488|EG003|Reported Event|Vitamin D>30ng/ml; Exercise|Exercise: Core stability, balance exercises
11338368|NCT03608774|BG000|Baseline|Azithromycin + Doxycycline Placebo|"1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89~Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.~Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days."
11338369|NCT03608774|BG001|Baseline|Doxycycline + Azithromycin Placebo|"100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88~Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.~Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose."
11338370|NCT03608774|BG002|Baseline|Total|Total of all reporting groups
11338371|NCT03608774|FG000|Participant Flow|Azithromycin + Doxycycline Placebo|"1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89~Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.~Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days."
11338372|NCT03608774|FG001|Participant Flow|Doxycycline + Azithromycin Placebo|"100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88~Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.~Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose."
11338373|NCT03608774|OG000|Outcome|Azithromycin + Doxycycline Placebo|"1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89~Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.~Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days."
11388012|NCT02536339|OG000|Outcome|Pertuzumab + Trastuzumab|Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.
11388013|NCT02536339|EG000|Reported Event|Pertuzumab + Trastuzumab|Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.
11388014|NCT02323295|BG000|Baseline|Non Surgical-Radiation Only|"Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)"
11388015|NCT02323295|BG001|Baseline|Malignant Tumor Surgery And Radiation|"The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)~Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor"
11388016|NCT02323295|BG002|Baseline|Total|Total of all reporting groups
11388017|NCT02323295|FG000|Participant Flow|Non Surgical-Radiation Only|"Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)"
11388018|NCT02323295|FG001|Participant Flow|Malignant Tumor Surgery And Radiation|"The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)~Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor"
11388019|NCT02323295|OG000|Outcome|Non Surgical-Radiation Only|"Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)"
11388020|NCT02323295|OG001|Outcome|Malignant Tumor Surgery And Radiation|"The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)~Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor"
11388021|NCT02323295|EG000|Reported Event|Non Surgical-Radiation Only|"Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)"
11388022|NCT02323295|EG001|Reported Event|Malignant Tumor Surgery And Radiation|"The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.~Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)~Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor"
11388023|NCT02050308|BG000|Baseline|Honoring the Gift of Heart Health|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388024|NCT02050308|BG001|Baseline|Internet-All Nations Breath of Life (I-ANBL)|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388025|NCT02050308|BG002|Baseline|Total|Total of all reporting groups
11388026|NCT02050308|FG000|Participant Flow|Honoring the Gift of Heart Health|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388027|NCT02050308|FG001|Participant Flow|Internet-All Nations Breath of Life (I-ANBL)|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388028|NCT02050308|OG000|Outcome|Honoring the Gift of Heart Health|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11197360|NCT02170688|BG001|Baseline|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11340457|NCT03654560|FG001|Participant Flow|Surgicel|"Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.~Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use."
11340458|NCT03654560|OG000|Outcome|HemoStyp|"Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.~HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use."
11340459|NCT03654560|OG001|Outcome|Surgicel|"Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.~Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use."
11340460|NCT03654560|EG000|Reported Event|HemoStyp|"Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.~HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use."
11340461|NCT03654560|EG001|Reported Event|Surgicel|"Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.~Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use."
11340462|NCT03655080|BG000|Baseline|Nab-Paclitaxel and Radiation Therapy|"10 fractions of 3Gy radiation therapy will be delivered.~A total of 4 chemoradiation blocks should be delivered ideally in consecutive days~On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel)~On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day~There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks"
11340463|NCT03655080|FG000|Participant Flow|Nab-Paclitaxel and Radiation Therapy|"10 fractions of 3Gy radiation therapy will be delivered.~A total of 4 chemoradiation blocks should be delivered ideally in consecutive days~On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel)~On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day~There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks"
11340464|NCT03655080|OG000|Outcome|Nab-Paclitaxel and Radiation Therapy|"10 fractions of 3Gy radiation therapy will be delivered.~A total of 4 chemoradiation blocks should be delivered ideally in consecutive days~On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel)~On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day~There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks"
11340465|NCT03655080|EG000|Reported Event|Nab-Paclitaxel and Radiation Therapy|"10 fractions of 3Gy radiation therapy will be delivered.~A total of 4 chemoradiation blocks should be delivered ideally in consecutive days~On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel)~On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day~There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks"
11340466|NCT03655106|BG000|Baseline|Standard Long IV 4.78 cm 20 g Catheter|"Placement of Standard Long IV 4.78 cm 20 g catheter~Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter"
11340467|NCT03655106|BG001|Baseline|Ultra-Long IV 6.35 cm 20 g Catheter|"Placement of Ultra-Long length IV 6.35 cm 20 g catheter~Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter"
11340468|NCT03655106|BG002|Baseline|Total|Total of all reporting groups
11340469|NCT03655106|FG000|Participant Flow|Standard Long IV 4.78 cm 20 g Catheter|"Placement of Standard Long IV 4.78 cm 20 g catheter~Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter"
11340470|NCT03655106|FG001|Participant Flow|Ultra-Long IV 6.35 cm 20 g Catheter|"Placement of Ultra-Long length IV 6.35 cm 20 g catheter~Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter"
11340471|NCT03655106|OG000|Outcome|Standard Long IV 4.78 cm 20 g Catheter|"Placement of Standard Long IV 4.78 cm 20 g catheter~Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter"
11340472|NCT03655106|OG001|Outcome|Ultra-Long IV 6.35 cm 20 g Catheter|"Placement of Ultra-Long length IV 6.35 cm 20 g catheter~Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter"
11340473|NCT03655106|EG000|Reported Event|Standard Long IV 4.78 cm 20 g Catheter|"Placement of Standard Long IV 4.78 cm 20 g catheter~Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter"
11340474|NCT03655106|EG001|Reported Event|Ultra-Long IV 6.35 cm 20 g Catheter|"Placement of Ultra-Long length IV 6.35 cm 20 g catheter~Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter"
11388029|NCT02050308|OG001|Outcome|Internet-All Nations Breath of Life (I-ANBL)|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388030|NCT02050308|OG000|Outcome|Internet All Nations Breath of Life|Internet based All Nations Breath of Life Smoking Cessation program
11388031|NCT02050308|OG001|Outcome|Honoring the Gift of Heart Health|Internet based heart healthy program to increase fruits and vegetables
11388032|NCT02050308|OG000|Outcome|I-ANBL|Internet All Nations Breath of Life
11388033|NCT02050308|OG001|Outcome|Honoring the Gift of Heart Health|Increasing fruit and vegetable consumption
11388034|NCT02050308|OG000|Outcome|Internet All Nations Breath of Life|Internet Based All Nations Breath of Life Smoking Cessation Program
11388035|NCT02050308|EG000|Reported Event|Honoring the Gift of Heart Health|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388036|NCT02050308|EG001|Reported Event|Internet-All Nations Breath of Life (I-ANBL)|"The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).~Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy."
11388037|NCT02036970|BG000|Baseline|Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.
11388038|NCT02036970|BG001|Baseline|Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.
11388039|NCT02036970|BG002|Baseline|Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 wer eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.
11388040|NCT02036970|BG003|Baseline|Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.
11388041|NCT02036970|BG004|Baseline|Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.
11388042|NCT02036970|BG005|Baseline|Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.
11388043|NCT02036970|BG006|Baseline|Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
11388044|NCT02036970|BG007|Baseline|Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.
11388045|NCT02036970|BG008|Baseline|Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received the same bardoxolone methyl dose once-daily from Week 16 and onwards.
11388046|NCT02036970|BG009|Baseline|Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.
11388047|NCT02036970|BG010|Baseline|Total|Total of all reporting groups
10803931|NCT01049035|OG002|Outcome|Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
11388048|NCT02036970|FG000|Participant Flow|Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label|Participants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards)
11388049|NCT02036970|FG001|Participant Flow|Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label|Participants received bardoxolone methyl 5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards)
11388050|NCT02036970|FG002|Participant Flow|Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label|Participants received bardoxolone methyl 10 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards)
11388051|NCT02036970|FG003|Participant Flow|Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label|Participants received bardoxolone methyl 20 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards)
11388052|NCT02036970|FG004|Participant Flow|Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg|Participants received bardoxolone methyl 2.5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards)
11388053|NCT02036970|FG005|Participant Flow|Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg|Participants received bardoxolone methyl 5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards)
11388054|NCT02036970|FG006|Participant Flow|Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Participants received bardoxolone methyl 10 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards)
11388055|NCT02036970|FG007|Participant Flow|Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg|Participants received bardoxolone methyl 20 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards)
11388056|NCT02036970|FG008|Participant Flow|Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg|Participants in Part 1 started with bardoxolone methyl 5 mg once-daily from Day 1 and escalated to bardoxolone methyl 10 mg once-daily starting at Week 4 thru Week 16. Participants who continued to Part 2 continued to receive the same bardoxolone methyl dose once-daily in Part 2 (Week 16 and onwards)
11388057|NCT02036970|FG009|Participant Flow|Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Participants in Part 1 received Placebo once-daily from Day 1 thru Week 16. Participants who continued to Part 2 initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from week 20 onwards
11388058|NCT02036970|OG000|Outcome|Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.
11388059|NCT02036970|OG001|Outcome|Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.
11388060|NCT02036970|OG002|Outcome|Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 wer eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.
11388061|NCT02036970|OG003|Outcome|Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.
11388062|NCT02036970|OG004|Outcome|Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.
11388063|NCT02036970|OG005|Outcome|Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.
11388064|NCT02036970|OG006|Outcome|Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
11388065|NCT02036970|OG007|Outcome|Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.
11388066|NCT02036970|OG008|Outcome|Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received the same bardoxolone methyl dose once-daily from Week 16 and onwards.
11388067|NCT02036970|OG009|Outcome|Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.
11388068|NCT02036970|EG000|Reported Event|Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16.
11388069|NCT02036970|EG001|Reported Event|Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16.
11388070|NCT02036970|EG002|Reported Event|Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16.
11388071|NCT02036970|EG003|Reported Event|Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label|Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16.
11388072|NCT02036970|EG004|Reported Event|Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16.
11388073|NCT02036970|EG005|Reported Event|Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16.
11388074|NCT02036970|EG006|Reported Event|Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16.
11388075|NCT02036970|EG007|Reported Event|Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16.
11388076|NCT02036970|EG008|Reported Event|Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16.
11388077|NCT02036970|EG009|Reported Event|Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16.
11388078|NCT02036970|EG010|Reported Event|Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label|Part 2: Participants who completed treatment receiving bardoxolone methyl 2.5 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.
11388079|NCT02036970|EG011|Reported Event|Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label|Part 2: Participants who completed treatment receiving bardoxolone methyl 5 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.
11388080|NCT02036970|EG012|Reported Event|Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label|Part 2: Participants who completed treatment receiving bardoxolone methyl 10 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.
11388081|NCT02036970|EG013|Reported Event|Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label|Part 2: Participants who completed treatment receiving bardoxolone methyl 20 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.
11388082|NCT02036970|EG014|Reported Event|Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg|Part 2: Participants who completed bardoxolone methyl matching placebo 2.5 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.
11388083|NCT02036970|EG015|Reported Event|Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg|Part 2: Participants who completed bardoxolone methyl matching placebo 5 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.
11388084|NCT02036970|EG016|Reported Event|Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 2: Participants who completed bardoxolone methyl matching placebo 10 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
11388085|NCT02036970|EG017|Reported Event|Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg|Part 2: Participants who completed bardoxolone methyl matching placebo 20 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.
11388086|NCT02036970|EG018|Reported Event|Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 2: Participants who completed treatment titrated to 10 mg bardoxolone methyl in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
11388087|NCT02036970|EG019|Reported Event|Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg|Part 2: Participants who completed bardoxolone methyl matching placebo 10 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.
11388088|NCT01941719|BG000|Baseline|Standard Foot Care Education|"Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams."
11388089|NCT01941719|BG001|Baseline|Enhanced Foot Care Education|"In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure~Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications."
11388090|NCT01941719|BG002|Baseline|Total|Total of all reporting groups
11388091|NCT01941719|FG000|Participant Flow|Standard Foot Care Education|"Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282). In addition, a 1-page diabetic footwear selection criteria is provided."
11388092|NCT01941719|FG001|Participant Flow|Enhanced Foot Care Education|In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure
11388093|NCT01941719|OG000|Outcome|Standard Foot Care Education|"Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282). Also, a 1-page supplementary diabetic footwear educational material was reviewed. The aims of education are to emphasize the importance of checking feet daily, highlighting diabetic foot complications that can arise from repetitive trauma and inappropriate footwear in the absence of protective sensation."
11388094|NCT01941719|OG001|Outcome|Enhanced Foot Care Education|"In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure~Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications."
11388095|NCT01941719|OG000|Outcome|Standard Foot Care Education|"Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams."
11388096|NCT01941719|EG000|Reported Event|Standard Foot Care Education|"Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams."
11388097|NCT01941719|EG001|Reported Event|Enhanced Foot Care Education|"In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure~Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications."
11388098|NCT01578967|BG000|Baseline|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
10803590|NCT03278626|EG000|Reported Event|Nivolimumab+Carboplatin/Paclitaxel+Radiation|"240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation~Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64))."
11388099|NCT01578967|FG000|Participant Flow|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11388100|NCT01578967|OG000|Outcome|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11388101|NCT01578967|OG000|Outcome|Grade 3|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11197361|NCT02170688|BG002|Baseline|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197362|NCT02170688|BG003|Baseline|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197363|NCT02170688|BG004|Baseline|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197364|NCT02170688|BG005|Baseline|Total|Total of all reporting groups
11388102|NCT01578967|OG001|Outcome|Grade 4|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11388103|NCT01578967|OG002|Outcome|Grade 5|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11388104|NCT01578967|EG000|Reported Event|ABVD Followed by Brentuximab Vedotin|"Single arm trial~Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.~ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
11388105|NCT01186003|BG000|Baseline|Standard Insulin Drip Therapy|Continuous IV insulin infusion without added detemir
11197365|NCT02170688|FG000|Participant Flow|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
11388106|NCT01186003|BG001|Baseline|Insulin Drip and Detemir|Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
11388107|NCT01186003|BG002|Baseline|Total|Total of all reporting groups
11388108|NCT01186003|FG000|Participant Flow|Standard Insulin Drip Therapy|Continuous IV insulin infusion without added detemir
11388109|NCT01186003|FG001|Participant Flow|Insulin Drip and Detemir|Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
11388110|NCT01186003|OG000|Outcome|Standard Insulin Drip Therapy|Continuous IV insulin infusion without added detemir
10803591|NCT03211858|BG000|Baseline|SAR341402|SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11388111|NCT01186003|OG001|Outcome|Insulin Drip and Detemir|Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
11388112|NCT01186003|EG000|Reported Event|Standard Insulin Drip Therapy|Continuous IV insulin infusion without added detemir
10803592|NCT03211858|BG001|Baseline|NovoLog/NovoRapid|NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
10803593|NCT03211858|BG002|Baseline|Total|Total of all reporting groups
11340475|NCT03655301|BG000|Baseline|Copanlisib (Aliqopa, BAY80-6946) + Metformin|Participants received 2 oral doses of metformin, 1 dose (1000 milligram [mg]) on Day 1 and 1 dose (1000 mg) on Day 8, and a single dose of copanlisib (60 mg, 1 h infusion) on Day 8. A wash-out period of 7 days was maintained between the 2 doses of metformin.
11340476|NCT03655301|FG000|Participant Flow|Copanlisib (Aliqopa, BAY80-6946) + Metformin|Participants received 2 oral doses of metformin, 1 dose (1000 milligram [mg]) on Day 1 and 1 dose (1000 mg) on Day 8, and a single dose of copanlisib (60 mg, 1 h infusion) on Day 8. A wash-out period of 7 days was maintained between the 2 doses of metformin.
11340477|NCT03655301|OG000|Outcome|Copanlisib (Aliqopa, BAY80-6946) + Metformin|Participants received 2 oral doses of metformin, 1 dose (1000 milligram [mg]) on Day 1 and 1 dose (1000 mg) on Day 8, and a single dose of copanlisib (60 mg, 1 h infusion) on Day 8. A wash-out period of 7 days was maintained between the 2 doses of metformin.
11340478|NCT03655301|EG000|Reported Event|Copanlisib (Aliqopa, BAY80-6946) + Metformin|Participants received 2 oral doses of metformin, 1 dose (1000 milligram [mg]) on Day 1 and 1 dose (1000 mg) on Day 8, and a single dose of copanlisib (60 mg, 1 h infusion) on Day 8. A wash-out period of 7 days was maintained between the 2 doses of metformin.
11340479|NCT03655405|BG000|Baseline|Individual Deprescribing Intervention|"Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).~Individual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval."
11340480|NCT03655405|BG001|Baseline|Control|Participants allocated to the control group will receive usual care.
11340481|NCT03655405|BG002|Baseline|Total|Total of all reporting groups
11340482|NCT03655405|FG000|Participant Flow|Individual Deprescribing Intervention|"Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).~Individual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval."
11340483|NCT03655405|FG001|Participant Flow|Control|Participants allocated to the control group will receive usual care.
11340484|NCT03655405|OG000|Outcome|Individual Deprescribing Intervention|"Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).~Individual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval."
11340485|NCT03655405|OG001|Outcome|Control|Participants allocated to the control group will receive usual care.
11340486|NCT03655405|EG000|Reported Event|0.911 0.911 Individual Deprescribing Intervention|"Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).~Individual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval."
11340487|NCT03655405|EG001|Reported Event|Control|Participants allocated to the control group will receive usual care.
11340488|NCT03655444|BG000|Baseline|Phase I: Abemaciclib + Nivolumab|"Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle~Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle."
11340489|NCT03655444|BG001|Baseline|Phase II: Abemaciclib + Nivolumab|"Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.~Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle."
11340490|NCT03655444|BG002|Baseline|Total|Total of all reporting groups
11340491|NCT03655444|FG000|Participant Flow|Phase I: Abemaciclib + Nivolumab|"Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle~Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle."
11340492|NCT03655444|FG001|Participant Flow|Phase II: Abemaciclib + Nivolumab|"Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.~Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle."
11340493|NCT03655444|OG000|Outcome|Phase I: Abemaciclib + Nivolumab|"Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle~Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle."
11340494|NCT03655444|OG001|Outcome|Phase II: Abemaciclib + Nivolumab|"Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.~Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle."
11388113|NCT01186003|EG001|Reported Event|Insulin Drip and Detemir|Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
11388114|NCT00943618|BG000|Baseline|Varenicline + Bupropion|Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
11388115|NCT00943618|BG001|Baseline|Varenicline|Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
11388116|NCT00943618|BG002|Baseline|Placebo|Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
11388117|NCT00943618|BG003|Baseline|Total|Total of all reporting groups
11388118|NCT00943618|FG000|Participant Flow|Varenicline + Bupropion|Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
11388119|NCT00943618|FG001|Participant Flow|Varenicline|Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
11388120|NCT00943618|FG002|Participant Flow|Placebo|Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
11388121|NCT00943618|OG000|Outcome|Varenicline + Bupropion|Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
11388122|NCT00943618|OG001|Outcome|Varenicline|Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
11388123|NCT00943618|OG002|Outcome|Placebo|Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
11388124|NCT00943618|EG000|Reported Event|Varenicline + Bupropion|Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
11388125|NCT00943618|EG001|Reported Event|Varenicline|Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
11388126|NCT00943618|EG002|Reported Event|Placebo|Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
10803594|NCT03211858|FG000|Participant Flow|SAR341402|SAR341402 100 units per milliliter (U/mL) subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
10803595|NCT03211858|FG001|Participant Flow|NovoLog/NovoRapid|NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine,up to Week 52.
11388127|NCT03938272|BG000|Baseline|Oxabact OC5 Capsules; OC5 in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388128|NCT03938272|BG001|Baseline|Oxabact OC5 Capsules; Placebo in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388129|NCT03938272|BG002|Baseline|Total|Total of all reporting groups
11388130|NCT03938272|FG000|Participant Flow|Oxabact OC5 Capsules; OC5 in ePHex|Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria was received in both the Core study OC-DB-02 (ePHex) and this open label extension
11388131|NCT03938272|FG001|Participant Flow|Oxabact OC5 Capsules; Placebo in ePHex|Placebo in the Core study OC-DB-02; and Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria in this open label extension
11388132|NCT03938272|OG000|Outcome|Oxabact OC5 Capsules; OC5 in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388133|NCT03938272|OG001|Outcome|Oxabact OC5 Capsules; Placebo in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388134|NCT03938272|EG000|Reported Event|Oxabact OC5 Capsules; OC5 in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388135|NCT03938272|EG001|Reported Event|Oxabact OC5 Capsules; Placeob in ePHex|"Oxabact OC5 - Oxalobacter formigenes Strain HC-1~Oxabact OC5 - Oxalobacter formigenes Strain HC-1: Live, commensal bacteria"
11388136|NCT03641339|BG000|Baseline|Single Exposure Cohort A: Aedes Aegypti|One vector feeding: Participants will undergo one feeding by Aedes aegypti mosquitoes and then three biopsies on Day 0 were performed
11388137|NCT03641339|BG001|Baseline|Multiple Exposure Cohort B: Aedes Aegypti|Four vector feeding: Participants will undergo four feedings by Aedes aegypti mosquitos each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388138|NCT03641339|BG002|Baseline|Single Exposure Cohort A: Anopheles Gambiae|One vector feeding: Participants will undergo one feeding by Anopheles gambiae mosquitoes and then three biopsies on Day 0 were performed
11388139|NCT03641339|BG003|Baseline|Multiple Exposure Cohort B: Anopheles Gambiae|Four vector feeding: Participants will undergo four feedings by Anopheles gambiae mosquitoes each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388140|NCT03641339|BG004|Baseline|Single Exposure Cohort A: Lutzomyia Longipalpis|One vector feeding: Participants will undergo one feeding by Lutzomyia longipalpis and then three biopsies on Day 0 were performed
11388141|NCT03641339|BG005|Baseline|Multiple Exposure Cohort B: Lutzomyia Longipalpis|Four vector feeding: Participants will undergo four feedings by Lutzomyia longipalpis each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388142|NCT03641339|BG006|Baseline|Total|Total of all reporting groups
11388143|NCT03641339|FG000|Participant Flow|Single Exposure Cohort A: Aedes Aegypti|One vector feeding: Participants will undergo one feeding by Aedes aegypti mosquitoes and then three biopsies on Day 0 were performed
11388144|NCT03641339|FG001|Participant Flow|Multiple Exposure Cohort B: Aedes Aegypti|Four vector feeding: Participants will undergo four feedings by Aedes aegypti mosquitos each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388145|NCT03641339|FG002|Participant Flow|Single Exposure Cohort A: Anopheles Gambiae|One vector feeding: Participants will undergo one feeding by Anopheles gambiae mosquitoes and then three biopsies on Day 0 were performed
11388146|NCT03641339|FG003|Participant Flow|Multiple Exposure Cohort B: Anopheles Gambiae|Four vector feeding: Participants will undergo four feedings by Anopheles gambiae mosquitoes each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388147|NCT03641339|FG004|Participant Flow|Single Exposure Cohort A: Lutzomyia Longipalpis|One vector feeding: Participants will undergo one feeding by Lutzomyia longipalpis and then three biopsies on Day 0 were performed
11388148|NCT03641339|FG005|Participant Flow|Multiple Exposure Cohort B: Lutzomyia Longipalpis|Four vector feeding: Participants will undergo four feedings by Lutzomyia longipalpis each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388149|NCT03641339|OG000|Outcome|Single Exposure Cohort A: Aedes Aegypti|One vector feeding: Participants will undergo one feeding by Aedes aegypti mosquitoes and then three biopsies on Day 0 were performed
11388150|NCT03641339|OG001|Outcome|Multiple Exposure Cohort B: Aedes Aegypti|Four vector feeding: Participants will undergo four feedings by Aedes aegypti mosquitos each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388151|NCT03641339|OG002|Outcome|Single Exposure Cohort A: Anopheles Gambiae|One vector feeding: Participants will undergo one feeding by Anopheles gambiae mosquitoes and then three biopsies on Day 0 were performed
11388152|NCT03641339|OG003|Outcome|Multiple Exposure Cohort B: Anopheles Gambiae|Four vector feeding: Participants will undergo four feedings by Anopheles gambiae mosquitoes each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388153|NCT03641339|OG004|Outcome|Single Exposure Cohort A: Lutzomyia Longipalpis|One vector feeding: Participants will undergo one feeding by Lutzomyia longipalpis and then three biopsies on Day 0 were performed
11388154|NCT03641339|OG005|Outcome|Multiple Exposure Cohort B: Lutzomyia Longipalpis|Four vector feeding: Participants will undergo four feedings by Lutzomyia longipalpis each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388155|NCT03641339|EG000|Reported Event|Single Exposure Cohort A: Aedes Aegypti|One vector feeding: Participants will undergo one feeding by Aedes aegypti mosquitoes and then three biopsies on Day 0 were performed
11388156|NCT03641339|EG001|Reported Event|Multiple Exposure Cohort B: Aedes Aegypti|Four vector feeding: Participants will undergo four feedings by Aedes aegypti mosquitos each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388157|NCT03641339|EG002|Reported Event|Single Exposure Cohort A: Anopheles Gambiae|One vector feeding: Participants will undergo one feeding by Anopheles gambiae mosquitoes and then three biopsies on Day 0 were performed
11388158|NCT03641339|EG003|Reported Event|Multiple Exposure Cohort B: Anopheles Gambiae|Four vector feeding: Participants will undergo four feedings by Anopheles gambiae mosquitoes each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388159|NCT03641339|EG004|Reported Event|Single Exposure Cohort A: Lutzomyia Longipalpis|One vector feeding: Participants will undergo one feeding by Lutzomyia longipalpis and then three biopsies on Day 0 were performed
11388160|NCT03641339|EG005|Reported Event|Multiple Exposure Cohort B: Lutzomyia Longipalpis|Four vector feeding: Participants will undergo four feedings by Lutzomyia longipalpis each about 2 weeks apart, with the same vector type. 3 biopsy procedures were performed after the 4th and final feeding
11388161|NCT03625466|BG000|Baseline|Part 1: Placebo|Participants received placebo matched to LUM/IVA in placebo-controlled period for 48 weeks.
11388162|NCT03625466|BG001|Baseline|Part 1: LUM/IVA|Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg FDC q12h in placebo-controlled period for 48 weeks. Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg FDC q12h in placebo-controlled period for 48 weeks.
10803596|NCT03211858|OG000|Outcome|SAR341402|SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11388163|NCT03625466|BG002|Baseline|Total|Total of all reporting groups
11388164|NCT03625466|FG000|Participant Flow|Part 1: Placebo|Participants received placebo matched to LUM/IVA in placebo-controlled period for 48 weeks.
11388165|NCT03625466|FG001|Participant Flow|Part 1: LUM/IVA|Participants weighing less than (<)14 kilograms (kg) at screening received LUM 100 milligrams (mg)/IVA 125 mg fixed-dose combination (FDC) every 12 hours (q12h) in placebo-controlled period for 48 weeks. Participants weighing greater than or equals to (>=)14 kg at screening received LUM 150 mg/IVA 188 mg FDC q12h in placebo-controlled period for 48 weeks.
11388166|NCT03625466|OG000|Outcome|Part 1: Placebo|Participants received placebo matched to LUM/IVA in placebo-controlled period for 48 weeks.
11388167|NCT03625466|OG001|Outcome|Part 1: LUM/IVA|Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg FDC q12h in placebo-controlled period for 48 weeks. Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg FDC q12h in placebo-controlled period for 48 weeks.
11388168|NCT03625466|EG000|Reported Event|Part 1: Placebo|Participants received placebo matched to LUM/IVA in placebo-controlled period for 48 weeks.
11388169|NCT03625466|EG001|Reported Event|Part 1: LUM/IVA|Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg FDC q12h in placebo-controlled period for 48 weeks. Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg FDC q12h in placebo-controlled period for 48 weeks.
11388170|NCT03317795|BG000|Baseline|Levonorgestrel IUS|"Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.~Levonorgestrel IUS: LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density."
11388171|NCT03317795|BG001|Baseline|Tranexamic Acid|"Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).~Tranexamic Acid: Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period."
11388172|NCT03317795|BG002|Baseline|Total|Total of all reporting groups
11388173|NCT03317795|FG000|Participant Flow|Levonorgestrel IUS|"Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.~Levonorgestrel IUS: LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density."
11388174|NCT03317795|FG001|Participant Flow|Tranexamic Acid|"Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).~Tranexamic Acid: Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period."
11388175|NCT03317795|OG000|Outcome|Levonorgestrel IUS|"Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.~Levonorgestrel IUS: LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density."
11388176|NCT03317795|OG001|Outcome|Tranexamic Acid|"Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).~Tranexamic Acid: Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period."
11388177|NCT03317795|EG000|Reported Event|Levonorgestrel IUS|"Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.~Levonorgestrel IUS: LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density."
11388178|NCT03317795|EG001|Reported Event|Tranexamic Acid|"Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).~Tranexamic Acid: Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period."
11388179|NCT03287245|BG000|Baseline|Ruxolitinib-naïve Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388180|NCT03287245|BG001|Baseline|Ruxolitinib-naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388181|NCT03287245|BG002|Baseline|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388182|NCT03287245|BG003|Baseline|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388183|NCT03287245|BG004|Baseline|Total|Total of all reporting groups
11388184|NCT03287245|FG000|Participant Flow|Ruxolitinib-naïve Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388185|NCT03287245|FG001|Participant Flow|Ruxolitinib-naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388186|NCT03287245|FG002|Participant Flow|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388187|NCT03287245|FG003|Participant Flow|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388188|NCT03287245|OG000|Outcome|Ruxolitinib-Naïve Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388189|NCT03287245|OG000|Outcome|Ruxolitinib-Naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388190|NCT03287245|OG001|Outcome|Ruxolitinib-Naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388191|NCT03287245|OG002|Outcome|Total Ruxolitinib-Naïve Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388192|NCT03287245|OG000|Outcome|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388193|NCT03287245|OG001|Outcome|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388194|NCT03287245|OG002|Outcome|Total Ruxolitinib-Resistant or Intolerant Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388195|NCT03287245|OG000|Outcome|Ruxolitinib-naïve Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388196|NCT03287245|OG001|Outcome|Ruxolitinib-naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388197|NCT03287245|OG002|Outcome|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388198|NCT03287245|OG003|Outcome|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388199|NCT03287245|OG001|Outcome|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388200|NCT03287245|OG000|Outcome|Ruxolitinib-naïve Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388201|NCT03287245|OG001|Outcome|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388202|NCT03287245|OG000|Outcome|All Ruxolitinib-Naïve Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388203|NCT03287245|OG001|Outcome|All Ruxolitinib-Resistant or Intolerant Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388204|NCT03287245|OG002|Outcome|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388205|NCT03287245|OG003|Outcome|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388206|NCT03287245|OG001|Outcome|Ruxolitinib-naïve Participants Without SplenomegalyEdit|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388207|NCT03287245|OG002|Outcome|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|t Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388208|NCT03287245|OG000|Outcome|Ruxolitinib-Naïve ParticipantsEditEdit|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388209|NCT03287245|OG001|Outcome|Ruxolitinib-Resistant or Intolerant Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years)
11388210|NCT03287245|OG000|Outcome|Ruxolitinib-Naïve Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388211|NCT03287245|OG001|Outcome|Ruxolitinib-Resistant or Intolerant Participants|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388212|NCT03287245|EG000|Reported Event|Ruxolitinib Naive-With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388213|NCT03287245|EG001|Reported Event|Ruxolitinib Naive-Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388214|NCT03287245|EG002|Reported Event|Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388215|NCT03287245|EG003|Reported Event|Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly|Participants received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years).
11388216|NCT03165916|BG000|Baseline|Reconstruction With Stent Placement|"Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.~Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own."
11388217|NCT03165916|BG001|Baseline|Reconstruction Without Stent Placement|Subjects will undergo biliary reconstruction without stent placement.
11388218|NCT03165916|BG002|Baseline|Total|Total of all reporting groups
11388219|NCT03165916|FG000|Participant Flow|Reconstruction With Stent Placement|"Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.~Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own."
11388220|NCT03165916|FG001|Participant Flow|Reconstruction Without Stent Placement|Subjects will undergo biliary reconstruction without stent placement.
11388221|NCT03165916|OG000|Outcome|Reconstruction With Stent Placement|"Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.~Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own."
11388222|NCT03165916|OG001|Outcome|Reconstruction Without Stent Placement|Subjects will undergo biliary reconstruction without stent placement.
11388223|NCT03165916|EG000|Reported Event|Reconstruction With Stent Placement|"Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.~Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own."
11388224|NCT03165916|EG001|Reported Event|Reconstruction Without Stent Placement|Subjects will undergo biliary reconstruction without stent placement.
11388225|NCT03092219|BG000|Baseline|TEOSYAL RHA Redensity|"Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL).~TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles."
11388226|NCT03092219|BG001|Baseline|No Treatment|No treatment control group
11388227|NCT03092219|BG002|Baseline|Total|Total of all reporting groups
11388228|NCT03092219|FG000|Participant Flow|TEOSYAL RHA Redensity|"Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL).~TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles."
11388229|NCT03092219|FG001|Participant Flow|No Treatment|No treatment control group.
10803597|NCT03211858|OG001|Outcome|NovoLog/NovoRapid|NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
10803598|NCT03211858|OG000|Outcome|Prior NovoLog/NovoRapid Use: SAR341402|Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11388230|NCT03092219|OG000|Outcome|TEOSYAL RHA Redensity|"Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL).~TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles."
11388231|NCT03092219|OG001|Outcome|No Treatment|No treatment control group.
11388232|NCT03092219|OG000|Outcome|SAFT Population|"The SAFT Population consisted of all subjects who were randomized and received at least one treatment with the study device during the course of the study (i.e. all subjects in the No-Treatment control group and all subjects in the TEOSYAL RHA® Redensity treatment group).~Of the 202 randomized subjects, 2 subjects did not receive any treatment during the whole study, resulting in a SAFT population of n=200.~It is to be remembered that subjects randomized to the No-Treatment control group received their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then followed the same schedule as the initial TEOSYAL RHA® Redensity treatment group."
11388233|NCT03092219|OG000|Outcome|Intent-to-Treat Pooled Population|The ITT Pooled Population consisted of all the subjects randomized.
11388234|NCT03092219|EG000|Reported Event|SAFT Population After Initial Treatment - V1/V1B to V9|"The SAFT Population consisted of all subjects who were randomized and received at least one treatment with the study device during the course of the study (i.e. all subjects in the No-Treatment control group and all subjects in the TEOSYAL RHA® Redensity treatment group).~Of the 202 randomized subjects, 2 subjects did not receive any treatment during the whole study, resulting in a SAFT population of n=200.~For this pooled analysis, only AEs onset on or after initial study treatment are included : from V1/V1B to V9 (W52 or 56 weeks for patients receiving a re-treatment at W52). Therefore, for No-Treatment group, all AEs with onset date before initial treatment, i.e. V1b date, are excluded from this summary table."
11388235|NCT03092219|EG001|Reported Event|No Treatment - V1 to V4|"No-Treatment group, before receiving initial treatment.~For this pooled analysis, only AEs of subjects from the non-treatment group from V1(Baseline) to V4 (Week 8) are included."
11388236|NCT03092219|EG002|Reported Event|Treatment Group - V1 to V4|RHA Redensity group (Treatment group) from V1(Baseline) to V4 (Week 8) are included.
11388237|NCT03033069|BG000|Baseline|Brexpiprazole + Sertraline|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388238|NCT03033069|BG001|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
11388239|NCT03033069|BG002|Baseline|Sertraline|Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388240|NCT03033069|BG003|Baseline|Placebo|Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week12.
11388241|NCT03033069|BG004|Baseline|Total|Total of all reporting groups
11388242|NCT03033069|FG000|Participant Flow|Brexpiprazole + Sertraline|Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388243|NCT03033069|FG001|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
11388244|NCT03033069|FG002|Participant Flow|Sertraline|Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388245|NCT03033069|FG003|Participant Flow|Placebo|Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.
11388246|NCT03033069|OG000|Outcome|Brexpiprazole + Sertraline|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388247|NCT03033069|OG001|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
11197366|NCT02170688|FG001|Participant Flow|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197367|NCT02170688|FG002|Participant Flow|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197368|NCT02170688|FG003|Participant Flow|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197369|NCT02170688|FG004|Participant Flow|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197370|NCT02170688|OG000|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
11197371|NCT02170688|OG001|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11340495|NCT03655444|OG000|Outcome|Phase I and Phase II: Abemaciclib + Nivolumab|"Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle~Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle."
11340496|NCT03655444|EG000|Reported Event|Phase I and Phase II: Abemaciclib + Nivolumab|"Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle~Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle."
11340497|NCT03655951|BG000|Baseline|Resource 1|"Web-based resource on adolescent sexual health~Web-based resource on adolescent sexual health: Web-based resource on adolescent sexual health than the intervention."
11340498|NCT03655951|BG001|Baseline|Resource 2|"Alternate web-based resource on adolescent sexual health~Alternate web-based resource on adolescent sexual health: This is a different web-based resource on adolescent sexual health than the intervention."
11340499|NCT03655951|BG002|Baseline|Total|Total of all reporting groups
11340500|NCT03655951|FG000|Participant Flow|Resource 1|"Web-based resource on adolescent sexual health~Web-based resource on adolescent sexual health: Web-based resource on adolescent sexual health than the intervention."
11340501|NCT03655951|FG001|Participant Flow|Resource 2|"Alternate web-based resource on adolescent sexual health~Alternate web-based resource on adolescent sexual health: This is a different web-based resource on adolescent sexual health than the intervention."
11340502|NCT03655951|OG000|Outcome|Resource 1|"Web-based resource on adolescent sexual health~Web-based resource on adolescent sexual health: Web-based resource on adolescent sexual health than the intervention."
11340503|NCT03655951|OG001|Outcome|Resource 2|"Alternate web-based resource on adolescent sexual health~Alternate web-based resource on adolescent sexual health: This is a different web-based resource on adolescent sexual health than the intervention."
10803599|NCT03211858|OG001|Outcome|Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid|Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11340504|NCT03655951|EG000|Reported Event|Resource 1|"Web-based resource on adolescent sexual health~Web-based resource on adolescent sexual health: Web-based resource on adolescent sexual health than the intervention."
11340505|NCT03655951|EG001|Reported Event|Resource 2|"Alternate web-based resource on adolescent sexual health~Alternate web-based resource on adolescent sexual health: This is a different web-based resource on adolescent sexual health than the intervention."
11340506|NCT03656939|BG000|Baseline|Prevenar 13|Main study cohort included participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Prospective study cohort included eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
11388248|NCT03033069|OG002|Outcome|Sertraline|Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388249|NCT03033069|OG003|Outcome|Placebo|Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.
11388250|NCT03033069|EG000|Reported Event|Brexpiprazole + Sertraline|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388251|NCT03033069|EG001|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
11388252|NCT03033069|EG002|Reported Event|Sertraline|Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
11388253|NCT03033069|EG003|Reported Event|Placebo|Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.
11388254|NCT02956434|BG000|Baseline|Brief Family Intervention - Veterans|"Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.~Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE."
11388255|NCT02956434|BG001|Baseline|Usual-care CPT/PE - Veterans|"Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.~Their chosen family member will NOT receive the BFI."
11388256|NCT02956434|BG002|Baseline|Brief Family Intervention - Family Members|"Family members will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.~Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."
11388257|NCT02956434|BG003|Baseline|No Intervention - Family Members|Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
11388258|NCT02956434|BG004|Baseline|Total|Total of all reporting groups
11388259|NCT02956434|FG000|Participant Flow|Brief Family Intervention - Veterans|"The family members of these veterans will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.~Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."
11388260|NCT02956434|FG001|Participant Flow|No Intervention - Veterans|The family members of these veterans will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
11388261|NCT02956434|FG002|Participant Flow|Brief Family Intervention - Family Members|"Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.~Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."
11388262|NCT02956434|FG003|Participant Flow|No Intervention - Family Members|These family members will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
11388263|NCT02956434|OG000|Outcome|Brief Family Intervention|"Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.~Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."
11388264|NCT02956434|OG001|Outcome|No Intervention|Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
11388265|NCT02956434|EG000|Reported Event|Brief Family Intervention - Veterans|"Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.~Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE."
11388266|NCT02956434|EG001|Reported Event|Usual-care CPT/PE - Veterans|"Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.~Their chosen family member will NOT receive the BFI."
11388267|NCT02956434|EG002|Reported Event|Brief Family Intervention - Family Members|"Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.~Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."
11388268|NCT02956434|EG003|Reported Event|No Intervention - Family Members|Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
11388269|NCT02609503|BG000|Baseline|Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388270|NCT02609503|FG000|Participant Flow|Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388271|NCT02609503|OG000|Outcome|Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388272|NCT02609503|OG000|Outcome|Baseline Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"Baseline Quality of life Measurements~All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388273|NCT02609503|OG001|Outcome|Week 10 Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"Week 10 Quality of life Measurements~All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388274|NCT02609503|OG002|Outcome|Week 20 Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"Week 20 Quality of life Measurements~All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388275|NCT02609503|EG000|Reported Event|Pembrolizumab Concomitant With and Post 7 Weeks of Radiation|"All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks.~Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses."
11388276|NCT02587598|BG000|Baseline|Parts 1 and 2: INCB053914 100 mg QD|INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
11388277|NCT02587598|BG001|Baseline|Parts 1 and 2: INCB053914 50 mg BID|INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
11388278|NCT02587598|BG002|Baseline|Parts 1 and 2: INB053914 65 mg BID|INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose.
11388279|NCT02587598|BG003|Baseline|Parts 1 and 2: INB053914 80 mg BID|INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose.
11388280|NCT02587598|BG004|Baseline|Parts 1 and 2: INB053914 100 mg BID|INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose.
11388281|NCT02587598|BG005|Baseline|Parts 1 and 2: INB053914 115 mg BID|INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
11388282|NCT02587598|BG006|Baseline|Parts 3 and 4: INCB053914 50 mg BID + Cytarabine|Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
11388283|NCT02587598|BG007|Baseline|Parts 3 and 4: INCB053914 50 mg BID + Azacitidine|Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID.
11388284|NCT02587598|BG008|Baseline|Part 3 and 4 - INCB053914 80 mg BID + Azacitidine|Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
11388285|NCT02587598|BG009|Baseline|Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
11388286|NCT02587598|BG010|Baseline|Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
11388287|NCT02587598|BG011|Baseline|Total|Total of all reporting groups
11388288|NCT02587598|FG000|Participant Flow|Parts 1 and 2: INCB053914 100 mg QD|INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.
11388289|NCT02587598|FG001|Participant Flow|Parts 1 and 2: INCB053914 50 mg BID|INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.
11388290|NCT02587598|FG002|Participant Flow|Parts 1 and 2: INB053914 65 mg BID|INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.
11388291|NCT02587598|FG003|Participant Flow|Parts 1 and 2: INB053914 80 mg BID|INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.
11388292|NCT02587598|FG004|Participant Flow|Parts 1 and 2: INB053914 100 mg BID|INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.
11388293|NCT02587598|FG005|Participant Flow|Parts 1 and 2: INB053914 115 mg BID|INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.
11388294|NCT02587598|FG006|Participant Flow|Parts 3 and 4: INCB053914 50 mg BID + Cytarabine|Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.
11388295|NCT02587598|FG007|Participant Flow|Parts 3 and 4: INCB053914 50 mg BID + Azacitidine|Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
11388296|NCT02587598|FG008|Participant Flow|Part 3 and 4 - INCB053914 80 mg BID + Azacitidine|Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
11388297|NCT02587598|FG009|Participant Flow|Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
11388298|NCT02587598|FG010|Participant Flow|Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
11388299|NCT02587598|OG000|Outcome|Parts 1 and 2: INCB053914 100 mg QD|INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose.
11388300|NCT02587598|OG001|Outcome|Parts 1 and 2: INCB053914 50 mg BID|INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose.
11388301|NCT02587598|OG002|Outcome|Parts 1 and 2: INB053914 65 mg BID|INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose
11388302|NCT02587598|OG003|Outcome|Parts 1 and 2: INB053914 80 mg BID|INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose.
11388303|NCT02587598|OG004|Outcome|Parts 1 and 2: INB053914 100 mg BID|INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose.
11388304|NCT02587598|OG005|Outcome|Parts 1 and 2: INB053914 115 mg BID|INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
11388305|NCT02587598|OG006|Outcome|Parts 3 and 4: INCB053914 50 mg BID + Cytarabine|Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
11388306|NCT02587598|OG007|Outcome|Parts 3 and 4: INCB053914 50 mg BID + Azacitidine|Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine
11388307|NCT02587598|OG008|Outcome|Parts 3 and 4: INCB053914 80 mg BID + Azacitine|Combination Treatment Group B: INCB053914 80 mg BID + Azacitine
11388308|NCT02587598|OG009|Outcome|Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib
11388309|NCT02587598|OG010|Outcome|Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib|Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
11388310|NCT02587598|OG000|Outcome|Part 4: INCB053914 50 mg BID + Cytarabine)|Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
11388311|NCT02587598|OG000|Outcome|Part 4: INCB053914 50 mg BID + Azacitidine|Combination Treatment Group B INCB053914 50 mg BID + Azacitidine
11388312|NCT02587598|OG001|Outcome|Part 4: INB053914 80 mg BID + Azactidine|Combination Treatment Group B: B053914 80 mg BID + Azactidine
11388313|NCT02587598|OG000|Outcome|Parts 1 and 2: INCB053914 100 mg QD|INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
11388314|NCT02587598|OG001|Outcome|Parts 1 and 2: INCB053914 50 mg BID|INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
11388315|NCT02587598|OG002|Outcome|Parts 1 and 2: INB053914 65 mg BID|INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.
11388316|NCT02587598|OG003|Outcome|Parts 1 and 2: INB053914 80 mg BID|INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.
11388317|NCT02587598|OG004|Outcome|Parts 1 and 2: INB053914 100 mg BID|INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.
11388318|NCT02587598|OG005|Outcome|Parts 1 and 2: INB053914 115 mg BID|INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.
11388319|NCT02587598|OG000|Outcome|Parts 3 & 4: INCB053914 50 mg BID + Cytarabine|Combination Group A: INCB053914 50 mg BID + Cytarabine
11388320|NCT02587598|OG000|Outcome|Parts 3 & 4: INCB053914 80 mg BID + Azacitidine|Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
11388321|NCT02587598|OG000|Outcome|Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib|Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
11388322|NCT02587598|EG000|Reported Event|Part 1 and 2 - INCB053914: 100 mg QD|Part 1 and 2 - INCB053914: 100 mg QD
11388323|NCT02587598|EG001|Reported Event|Part 1 and 2 - INCB053914: 50 mg BID|Part 1 and 2 - INCB053914: 50 mg BID
11388324|NCT02587598|EG002|Reported Event|Part 1 and 2 - INCB053914: 65 mg BID|Part 1 and 2 - INCB053914: 65 mg BID
11388325|NCT02587598|EG003|Reported Event|Part 1 and 2 - INCB053914: 80 mg BID|Part 1 and 2 - INCB053914: 80 mg BID
11388326|NCT02587598|EG004|Reported Event|Part 1 and 2 - INCB053914: 100 mg BID|Part 1 and 2 - INCB053914: 100 mg BID
11388327|NCT02587598|EG005|Reported Event|Part 1 and 2 - INCB053914: 115 mg BID|Part 1 and 2 - INCB053914: 115 mg BID
11388328|NCT02587598|EG006|Reported Event|Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine|Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine
11388329|NCT02587598|EG007|Reported Event|Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine|Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine
11388330|NCT02587598|EG008|Reported Event|Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine|Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine
11388331|NCT02587598|EG009|Reported Event|Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib|Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib
11388332|NCT02587598|EG010|Reported Event|Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib|Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
11388333|NCT02485574|BG000|Baseline|All Study Participants|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted. We compared the anterior bone bridging patterns of two cages in each patient.
11388334|NCT02485574|FG000|Participant Flow|All Study Participants - Single Group|"Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted in same segment. We compared the anterior bone bridging patterns of two cages at single operated segment in each patient."
11388335|NCT02485574|OG000|Outcome|Left Cage- Auto Bone|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.
11388336|NCT02485574|OG001|Outcome|Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
11388337|NCT02485574|OG000|Outcome|Left Cage- Auto Bonegroup|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.
11388338|NCT02485574|OG000|Outcome|Interbody Fused Group|"We determined the interbody fusion as in cases with at least one or more complete InCBB and/or ExCBB on both sagittal and coronal views simultaneously without subsidence.~This group was classified as having achieved interbody fusion."
11388339|NCT02485574|OG001|Outcome|Interbody Unfused Group|"We determined the interbody fusion in cases with at least one or more complete InCBB and/or ExCBB on both sagittal and coronal views simultaneously without subsidence.~This group was classified as not having achieved interbody fusion."
11388340|NCT02485574|EG000|Reported Event|Left Cage- Auto Bone|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.
11388341|NCT02485574|EG001|Reported Event|Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite|Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
11388342|NCT02214160|BG000|Baseline|UX007-CL201-Rollover Cohort|Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388343|NCT02214160|BG001|Baseline|IST/Other Cohort|Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388344|NCT02214160|BG002|Baseline|Triheptanoin-Naïve Cohort|Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388345|NCT02214160|BG003|Baseline|Total|Total of all reporting groups
11388346|NCT02214160|FG000|Participant Flow|UX007-CL201-Rollover Cohort|Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388347|NCT02214160|FG001|Participant Flow|IST/Other Cohort|Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
10803600|NCT03211858|OG002|Outcome|Prior Humalog/Liprolog Use: SAR341402|Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
10803601|NCT03211858|OG003|Outcome|Prior Humalog/Liprolog Use: NovoLog/NovoRapid|Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11388348|NCT02214160|FG002|Participant Flow|Triheptanoin-Naïve Cohort|Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388349|NCT02214160|OG000|Outcome|UX007-CL201-Rollover Cohort|Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388350|NCT02214160|OG000|Outcome|IST/Other Cohort|Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388351|NCT02214160|OG001|Outcome|Triheptanoin-Naïve Cohort|Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388352|NCT02214160|OG001|Outcome|IST/Other Cohort|Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388353|NCT02214160|OG002|Outcome|Triheptanoin-Naïve Cohort|Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388354|NCT02214160|OG002|Outcome|Triheptanoin-Naïve Cohort|"Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.~-"
11388355|NCT02214160|EG000|Reported Event|UX007-CL201-Rollover Cohort|Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388356|NCT02214160|EG001|Reported Event|IST/Other Cohort|Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388357|NCT02214160|EG002|Reported Event|Triheptanoin-Naïve Cohort|Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388358|NCT02214160|EG003|Reported Event|All Participants|All participants received UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.
11388359|NCT01899261|BG000|Baseline|Treatment (SBRT)|"Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.~Stereotactic Radiosurgery: Undergo SBRT"
11388360|NCT01899261|FG000|Participant Flow|Treatment (SBRT)|"Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.~Stereotactic Radiosurgery: Undergo SBRT"
11388361|NCT01899261|OG000|Outcome|Treatment (SBRT)|"Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.~Stereotactic Radiosurgery: Undergo SBRT"
11388362|NCT01899261|EG000|Reported Event|Treatment (SBRT)|"Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.~Stereotactic Radiosurgery: Undergo SBRT"
11388363|NCT01595503|BG000|Baseline|rTMS With fMRI-based Targeting or Landmark Based Targeting|rTMS: Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
11388364|NCT01595503|FG000|Participant Flow|rTMS With Either fMRI-based Targeting or Landmark Based Targeting.|rTMS Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
11388365|NCT01595503|OG000|Outcome|rTMS|rTMS : Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
11388366|NCT01595503|EG000|Reported Event|rTMS|rTMS : Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
11388367|NCT01460160|BG000|Baseline|Dasatinib Cohort|Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
10803602|NCT03211858|EG000|Reported Event|SAR341402|SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
10803603|NCT03211858|EG001|Reported Event|NovoLog/NovoRapid|NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11388368|NCT01460160|FG000|Participant Flow|Dasatinib Cohort|Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
11388369|NCT01460160|OG000|Outcome|Dasatinib Cohort|Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
11388370|NCT01460160|EG000|Reported Event|Dasatinib Cohort|Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
11388371|NCT01170702|BG000|Baseline|Group 1|"TAP Block utilizing 15mL of 0.9% normal saline per side~0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388372|NCT01170702|BG001|Baseline|Group 2|"TAP Block utilizing 15ml of 0.2% ropivacaine per side~0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388373|NCT01170702|BG002|Baseline|Group 3|"TAP Block utilizing 15ml of 0.5% ropivacaine per side~0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388374|NCT01170702|BG003|Baseline|Group 4|"TAP Block utilizing 15ml of 0.75% ropivacaine per side~0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388375|NCT01170702|BG004|Baseline|Total|Total of all reporting groups
11388376|NCT01170702|FG000|Participant Flow|Group 1|"TAP Block utilizing 15mL of 0.9% normal saline per side~0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388377|NCT01170702|FG001|Participant Flow|Group 2|"TAP Block utilizing 15ml of 0.2% ropivacaine per side~0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388378|NCT01170702|FG002|Participant Flow|Group 3|"TAP Block utilizing 15ml of 0.5% ropivacaine per side~0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388379|NCT01170702|FG003|Participant Flow|Group 4|"TAP Block utilizing 15ml of 0.75% ropivacaine per side~0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388380|NCT01170702|OG000|Outcome|Group 1|"TAP Block utilizing 15mL of 0.9% normal saline per side~0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11338374|NCT03608774|OG001|Outcome|Doxycycline + Azithromycin Placebo|"100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88~Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.~Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose."
11338375|NCT03608774|EG000|Reported Event|Azithromycin + Doxycycline Placebo|"1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89~Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.~Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days."
11338376|NCT03608774|EG001|Reported Event|Doxycycline + Azithromycin Placebo|"100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88~Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.~Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose."
11338377|NCT03608839|BG000|Baseline|0,01ml Dexamethasone Solution|"One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection."
11338378|NCT03608839|BG001|Baseline|0,03 ml Dexamethasone Solution|"One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection."
11338379|NCT03608839|BG002|Baseline|0,05 ml Dexamethasone Solution|"One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection."
11338380|NCT03608839|BG003|Baseline|Total|Total of all reporting groups
11338381|NCT03608839|FG000|Participant Flow|0,01ml Dexamethasone Solution|"One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection."
11338382|NCT03608839|FG001|Participant Flow|0,03 ml Dexamethasone Solution|"One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection."
11338383|NCT03608839|FG002|Participant Flow|0,05 ml Dexamethasone Solution|"One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection."
11338384|NCT03608839|OG000|Outcome|0,01ml Dexamethasone Solution|"One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection."
11338385|NCT03608839|OG001|Outcome|0,03 ml Dexamethasone Solution|"One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection."
11338386|NCT03608839|OG002|Outcome|0,05 ml Dexamethasone Solution|"One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection."
11338387|NCT03608839|EG000|Reported Event|0,01ml Dexamethasone Solution|"One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection."
11338388|NCT03608839|EG001|Reported Event|0,03 ml Dexamethasone Solution|"One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection."
11338389|NCT03608839|EG002|Reported Event|0,05 ml Dexamethasone Solution|"One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.~Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection."
11338390|NCT03609619|BG000|Baseline|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
11338391|NCT03609619|BG001|Baseline|Placebo|Oral doses of Placebo administered b.i.d.
11338392|NCT03609619|BG002|Baseline|Total|Total of all reporting groups
11338393|NCT03609619|FG000|Participant Flow|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
11338394|NCT03609619|FG001|Participant Flow|Placebo|Oral doses of Placebo administered b.i.d.
11338395|NCT03609619|OG000|Outcome|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
11338396|NCT03609619|OG001|Outcome|Placebo|Oral doses of Placebo administered b.i.d.
11338397|NCT03609619|EG000|Reported Event|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg administered b.i.d.
11338398|NCT03609619|EG001|Reported Event|Placebo|Oral doses of Placebo administered b.i.d.
11338399|NCT03609658|BG000|Baseline|Nurse Navigator Pathway Group|"Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)~Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."
11338400|NCT03609658|BG001|Baseline|Usual Care Group|"Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).~Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm."
11338401|NCT03609658|BG002|Baseline|Total|Total of all reporting groups
11340507|NCT03656939|FG000|Participant Flow|Prevenar 13|Main study cohort included participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Prospective study cohort included eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
11340508|NCT03656939|OG000|Outcome|Prevenar 13: Main Study Cohort|Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
11340509|NCT03656939|OG001|Outcome|Prevenar 13 Cohort: Prospective Cohort Study|In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
11340510|NCT03656939|EG000|Reported Event|Prevenar 13: Main Study Cohort|Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
11340511|NCT03656939|EG001|Reported Event|Prevenar 13 Cohort: Prospective Cohort Study|In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
11340512|NCT03657095|BG000|Baseline|Esuberaprost|Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).
11340513|NCT03657095|BG001|Baseline|Placebo/Esuberaprost|Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
11340514|NCT03657095|BG002|Baseline|Total|Total of all reporting groups
11340515|NCT03657095|FG000|Participant Flow|Esuberaprost|Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 microgram (μg) esuberaprost sodium tablets for oral administration 4 times daily (QID) for up to 7 months (which included the 4 weeks of blinded transition).
11340516|NCT03657095|FG001|Participant Flow|Placebo/Esuberaprost|Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
11340517|NCT03657095|OG000|Outcome|Esuberaprost|Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).
11340518|NCT03657095|OG001|Outcome|Placebo/Esuberaprost|Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
11340519|NCT03657095|EG000|Reported Event|Esuberaprost|Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).
11340520|NCT03657095|EG001|Reported Event|Placebo/Esuberaprost|Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
11340521|NCT03657134|BG000|Baseline|EP Procedure|"Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively.~CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively."
11340522|NCT03657134|FG000|Participant Flow|EP Procedure|"Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively.~CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively."
11340523|NCT03657134|OG000|Outcome|EP Procedure|"Patient will continuously wear the CoVa-2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively.~CoVa-2 Sensor: Upon completion of EP procedure, CoVa 2-sensor will be applied until discharge."
11340524|NCT03657134|OG000|Outcome|EP Procedure|"Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively.~CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively."
11340525|NCT03657134|EG000|Reported Event|EP Procedure|"Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively.~CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively."
11388381|NCT01170702|OG001|Outcome|Group 2|"TAP Block utilizing 15ml of 0.2% ropivacaine per side~0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388382|NCT01170702|OG002|Outcome|Group 3|"TAP Block utilizing 15ml of 0.5% ropivacaine per side~0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388383|NCT01170702|OG003|Outcome|Group 4|"TAP Block utilizing 15ml of 0.75% ropivacaine per side~0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388384|NCT01170702|EG000|Reported Event|Group 1|"TAP Block utilizing 15mL of 0.9% normal saline per side~0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388385|NCT01170702|EG001|Reported Event|Group 2|"TAP Block utilizing 15ml of 0.2% ropivacaine per side~0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388386|NCT01170702|EG002|Reported Event|Group 3|"TAP Block utilizing 15ml of 0.5% ropivacaine per side~0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11388387|NCT01170702|EG003|Reported Event|Group 4|"TAP Block utilizing 15ml of 0.75% ropivacaine per side~0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side."
11197372|NCT02170688|OG002|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197373|NCT02170688|OG003|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197374|NCT02170688|OG004|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197375|NCT02170688|EG000|Reported Event|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
11388388|NCT01018563|BG000|Baseline|Farletuzumab- All Participants|Participants received farletuzumab 62.5 or 100 mg/m^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to 37.7 months in this study.
11388389|NCT01018563|FG000|Participant Flow|Farletuzumab 62.5 mg/m^2|Participants received farletuzumab 62.5 milligram per meter square (mg/m^2), intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
11388390|NCT01018563|FG001|Participant Flow|Farletuzumab 100 mg/m^2|Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388391|NCT01018563|OG000|Outcome|Farletuzumab 62.5 mg/m^2|Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
11388392|NCT01018563|OG001|Outcome|Farletuzumab 100 mg/m^2|Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
11388393|NCT01018563|OG000|Outcome|Farletuzumab 62.5 mg/m^2|Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388394|NCT01018563|OG001|Outcome|Farletuzumab 100 mg/m^2|Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388395|NCT01018563|OG000|Outcome|Farletuzumab 62.5 mg/m^2|Participants received chemotherapy plus farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388396|NCT01018563|OG001|Outcome|Farletuzumab 100 mg/m^2|Participants received chemotherapy plus farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388397|NCT01018563|EG000|Reported Event|Farletuzumab 62.5 mg/m^2|Participants received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388398|NCT01018563|EG001|Reported Event|Farletuzumab 100 mg/m^2|Participants received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
11388399|NCT00805961|BG000|Baseline|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
11388400|NCT00805961|FG000|Participant Flow|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
11388401|NCT00805961|OG000|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
11388402|NCT00805961|EG000|Reported Event|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
11340526|NCT03657264|BG000|Baseline|Sequence 1|"The sequence of administration is: P/ScD/PC/CD~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340527|NCT03657264|BG001|Baseline|Sequence 2|"The sequence of administration is: CD/PC/ScD/P~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340528|NCT03657264|BG002|Baseline|Sequence 3|"The sequence of administration is: ScD/CD/P/PC~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340529|NCT03657264|BG003|Baseline|Sequence 4|"The sequence of administration is: PC/P/CD/ScD~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340530|NCT03657264|BG004|Baseline|Total|Total of all reporting groups
11340531|NCT03657264|FG000|Participant Flow|Sequence 1|"The sequence of administration is: P/ScD/PC/CD~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340532|NCT03657264|FG001|Participant Flow|Sequence 2|"The sequence of administration is: CD/PC/ScD/P~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340533|NCT03657264|FG002|Participant Flow|Sequence 3|"The sequence of administration is: ScD/CD/P/PC~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340534|NCT03657264|FG003|Participant Flow|Sequence 4|"The sequence of administration is: PC/P/CD/ScD~Where:~P = Placebo (Nacl 0.9%)~CD = P03277 tested at 0.1 mmol/kg~ScD = P03277 tested at 0.3 mmol/kg~PC = Positive control (moxifloxacin 400 mg - per os)."
11340535|NCT03657264|OG000|Outcome|P03277 0.1 mmol/kg|All subjects who received P03277 at 0.1 mmol/kg.
11340536|NCT03657264|OG001|Outcome|P03277 0.3 mmol/kg|All subjects who received P03277 at 0.3 mmol/kg.
11340537|NCT03657264|OG002|Outcome|Placebo|All subjects who received placebo.
11340538|NCT03657264|OG000|Outcome|Positive Control (Moxifloxacin)|All subjects who received moxifloxacin.
11340539|NCT03657264|OG001|Outcome|Placebo|All subjects who received placebo.
11340540|NCT03657264|EG000|Reported Event|P03277 0.1 mmol/kg|All subjects who received P03277 at 0.1 mmol/kg.
11340541|NCT03657264|EG001|Reported Event|P03277 0.3 mmol/kg|All subjects who received P03277 at 0.3 mmol/kg.
11340542|NCT03657264|EG002|Reported Event|Positive Control (Moxifloxacin)|All subjects who received Moxifloxacin.
11340543|NCT03657264|EG003|Reported Event|Placebo|All subjects who received placebo.
11340544|NCT03657277|BG000|Baseline|Micropatch Application|This is the only study arm, which all participants complete. Five sites each on each the upper arm, forearm, and abdomen will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and skin color will be made. Micropatches will be applied at three sites (at each body location). This only occurs on the first study day. Trans-epidermal water loss and electrical resistance are re-measured immediately after micropatch application. The sites will be covered with a small patch secured with medical tape. One site at each location will just be covered with a patch. The last site will not have micropatch application or patches. Electrical resistance will be re-measured at all sites for 3 days. Measurements from the 4th and 5th sites allow each subject to serve as their own control in data analysis.
11340545|NCT03657277|FG000|Participant Flow|Micropatch Application|This is the only study arm, which all participants complete. Five sites each on each the upper arm, forearm, and abdomen will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and skin color will be made. Micropatches will be applied at three sites (at each body location). This only occurs on the first study day. Trans-epidermal water loss and electrical resistance are re-measured immediately after micropatch application. The sites will be covered with a small patch secured with medical tape. One site at each location will just be covered with a patch. The last site will not have micropatch application or patches. Electrical resistance will be re-measured at all sites for 3 days. Measurements from the 4th and 5th sites allow each subject to serve as their own control in data analysis.
11340546|NCT03657277|OG000|Outcome|Micropatch Application|This is the only study arm, which all participants complete. Five sites each on each the upper arm, forearm, and abdomen will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and skin color will be made. Micropatches will be applied at three sites (at each body location). This only occurs on the first study day. Trans-epidermal water loss and electrical resistance are re-measured immediately after micropatch application. The sites will be covered with a small patch secured with medical tape. One site at each location will just be covered with a patch. The last site will not have micropatch application or patches. Electrical resistance will be re-measured at all sites for 3 days. Measurements from the 4th and 5th sites allow each subject to serve as their own control in data analysis.
11340547|NCT03657277|EG000|Reported Event|Micropatch Application|This is the only study arm, which all participants complete. Five sites each on each the upper arm, forearm, and abdomen will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and skin color will be made. Micropatches will be applied at three sites (at each body location). This only occurs on the first study day. Trans-epidermal water loss and electrical resistance are re-measured immediately after micropatch application. The sites will be covered with a small patch secured with medical tape. One site at each location will just be covered with a patch. The last site will not have micropatch application or patches. Electrical resistance will be re-measured at all sites for 3 days. Measurements from the 4th and 5th sites allow each subject to serve as their own control in data analysis.
11340548|NCT03657407|BG000|Baseline|Belladonna & Opium|"29 women randomized to Belladonna & Opium suppository~Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository"
11340549|NCT03657407|BG001|Baseline|Placebo|"27 women randomized to Glycerin suppository~Glycerin Suppository: Glycerine rectal suppository"
11340550|NCT03657407|BG002|Baseline|Total|Total of all reporting groups
11340551|NCT03657407|FG000|Participant Flow|Belladonna & Opium|"29 women randomized to Belladonna & Opium suppository~Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository"
11388403|NCT04056182|BG000|Baseline|Lofexidine|"Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.~Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol."
11388404|NCT04056182|FG000|Participant Flow|Lofexidine|"Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.~Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol."
11388405|NCT04056182|OG000|Outcome|Lofexidine|"Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.~Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol."
11388406|NCT04056182|EG000|Reported Event|Lofexidine|"Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.~Lofexidine 0.18 MG: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol."
11388407|NCT03954106|BG000|Baseline|Part 1: Safety Lead-In, Defibrotide 2.5 mg/kg/Dose|Participants who received the safety (lead in) dose of 2.5 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11388408|NCT03954106|BG001|Baseline|Phase 2: RP2D, Defibrotide 6.25 mg/kg/Dose|Participants who received the recommended phase 2 dose of 6.25 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11388409|NCT03954106|BG002|Baseline|Total|Total of all reporting groups
11388410|NCT03954106|FG000|Participant Flow|Part 1: Safety Lead-In, Defibrotide 2.5 mg/kg/Dose|Participants who received the safety (lead in) dose of 2.5 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11197376|NCT02170688|EG001|Reported Event|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197377|NCT02170688|EG002|Reported Event|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11388411|NCT03954106|FG001|Participant Flow|Phase 2: RP2D, Defibrotide 6.25 mg/kg/Dose|Participants who received the recommended phase 2 dose of 6.25 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11388412|NCT03954106|OG000|Outcome|Stage 1: Defibrotide, 6.25 mg/kg/Dose|Participants who either received the safety (lead in) dose of 6.25 mg/kg/dose defibrotide in Part 1 (n=4) or received the RP2D of 6.25 mg/kg/dose defibrotide in Part 2 (n=6) once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7). Stage 1 participants are the first 10 efficacy evaluable participants.
11388413|NCT03954106|OG001|Outcome|Stage 2: Defibrotide, 6.25 mg/kg/Dose|Participants who received the RP2D of 6.25 mg/kg/dose defibrotide in Part 2 (n=10) once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7). Stage 2 participants include the additional efficacy evaluable participants enrolled after the completion of Stage 1.
11388414|NCT03954106|OG002|Outcome|Overall: Defibrotide, 6.25 mg/kg/Dose|All participants who received 6.25 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7) in Stage 1 and Stage 2.
11388415|NCT03954106|OG000|Outcome|Overall: Defibrotide, 6.25 mg/kg/Dose|All participants who received 6.25 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7) in Stage 1 and Stage 2.
11388416|NCT03954106|EG000|Reported Event|Part 1: Safety Lead-In, Defibrotide 2.5 mg/kg/Dose|Participants who received the safety (lead in) dose of 2.5 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11388417|NCT03954106|EG001|Reported Event|Phase 2: RP2D, 6.25 mg/kg/Dose|Participants who received the recommended phase 2 dose of 6.25 mg/kg/dose defibrotide once daily as a single dose on CAR-T Day -5, -4, and -3 prior to lymphodepletion and then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
11388418|NCT03921424|BG000|Baseline|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388419|NCT03921424|BG001|Baseline|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388420|NCT03921424|BG002|Baseline|Total|Total of all reporting groups
11388421|NCT03921424|FG000|Participant Flow|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11197378|NCT02170688|EG003|Reported Event|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197379|NCT02170688|EG004|Reported Event|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
11197380|NCT02170727|BG000|Baseline|Treatment-Naive: DCV/ASV/BMS-791325|Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197381|NCT02170727|BG001|Baseline|Treatment-Experianced:|Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197382|NCT02170727|BG002|Baseline|Total|Total of all reporting groups
11197383|NCT02170727|FG000|Participant Flow|Treatment-Naive: DCV/ASV/BMS-791325|Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197384|NCT02170727|FG001|Participant Flow|Treatment-Experianced:|Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197385|NCT02170727|OG000|Outcome|Treatment-Naive: DCV/ASV/BMS-791325|Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197386|NCT02170727|OG001|Outcome|Treatment-Experianced:|Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197387|NCT02170727|OG000|Outcome|On-Treatment Safety of DCV 3DAA - Cirrhotic|
11197388|NCT02170727|OG001|Outcome|On-Treatment Safety - Noncirrhotic|
11197389|NCT02170727|OG001|Outcome|On-Treatment Safety of DCV 3DAA - Noncirrhotic|
11197390|NCT02170727|EG000|Reported Event|Treatment-Naive: DCV/ASV/BMS-791325|Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197391|NCT02170727|EG001|Reported Event|Treatment-Experianced:|Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
11197392|NCT02170779|BG000|Baseline|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
11197393|NCT02170779|BG001|Baseline|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
11197394|NCT02170779|BG002|Baseline|Total|Total of all reporting groups
11197395|NCT02170779|FG000|Participant Flow|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
11197396|NCT02170779|FG001|Participant Flow|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
11197397|NCT02170779|OG000|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
11197398|NCT02170779|OG001|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
11197399|NCT02170779|EG000|Reported Event|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
11197400|NCT02170779|EG001|Reported Event|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
11197401|NCT02170870|BG000|Baseline|Healthy Controls Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197402|NCT02170870|BG001|Baseline|Healthy Controls Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197403|NCT02170870|BG002|Baseline|Diabetics Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197404|NCT02170870|BG003|Baseline|Diabetics Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197405|NCT02170870|BG004|Baseline|Functional Dyspepsia Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197406|NCT02170870|BG005|Baseline|Functional Dyspepsia Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197407|NCT02170870|BG006|Baseline|Total|Total of all reporting groups
11340552|NCT03657407|FG001|Participant Flow|Placebo|"27 women randomized to Glycerin suppository~Glycerin Suppository: Glycerine rectal suppository"
11197408|NCT02170870|FG000|Participant Flow|Healthy Controls Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197409|NCT02170870|FG001|Participant Flow|Healthy Controls Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)
11197410|NCT02170870|FG002|Participant Flow|Diabetics Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)"
11197411|NCT02170870|FG003|Participant Flow|Diabetics Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11388422|NCT03921424|FG001|Participant Flow|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388423|NCT03921424|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388424|NCT03921424|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388425|NCT03921424|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
11388426|NCT03921424|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
11388427|NCT03921424|EG002|Reported Event|V114 (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11197412|NCT02170870|FG004|Participant Flow|Functional Dyspepsia Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197413|NCT02170870|FG005|Participant Flow|Functional Dyspepsia Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197414|NCT02170870|OG000|Outcome|Healthy Controls Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197415|NCT02170870|OG001|Outcome|Healthy Controls Placebo|"Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).~Microlipid: Lipid infusion {66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11388428|NCT03921424|EG003|Reported Event|Prevnar 13™ (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
11388429|NCT03598777|BG000|Baseline|Placebo|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11197416|NCT02170870|OG002|Outcome|Diabetics Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11388430|NCT03598777|BG001|Baseline|Dysport 100 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388431|NCT03598777|BG002|Baseline|Dysport 300 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388432|NCT03598777|BG003|Baseline|Dysport 400 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11197417|NCT02170870|OG003|Outcome|Diabetics Placebo|"Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).~Microlipid: Lipid infusion {66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197418|NCT02170870|OG004|Outcome|Functional Dyspepsia Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197419|NCT02170870|OG005|Outcome|Functional Dyspepsia Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197420|NCT02170870|OG000|Outcome|Healthy Controls|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197421|NCT02170870|OG001|Outcome|Healthy Controls Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11388433|NCT03598777|BG004|Baseline|Dysport 500 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388434|NCT03598777|BG005|Baseline|Total|Total of all reporting groups
11388435|NCT03598777|FG000|Participant Flow|Placebo|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388436|NCT03598777|FG001|Participant Flow|Dysport 100 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388437|NCT03598777|FG002|Participant Flow|Dysport 300 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388438|NCT03598777|FG003|Participant Flow|Dysport 400 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388439|NCT03598777|FG004|Participant Flow|Dysport 500 U|"Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388440|NCT03598777|OG000|Outcome|Placebo|Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388441|NCT03598777|OG001|Outcome|Dysport 100 U|Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388442|NCT03598777|OG002|Outcome|Dysport 300 U|Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388443|NCT03598777|OG003|Outcome|Dysport 400 U|Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388444|NCT03598777|OG004|Outcome|Dysport 500 U|Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388445|NCT03598777|OG000|Outcome|Placebo|Stage 2: On Cycle 1 Day 1 in the DB treatment period, participants were to receive placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388446|NCT03598777|OG001|Outcome|Dysport High Dose|Stage 2: On Cycle 1 Day 1 in the DB treatment period, participants were to receive Dysport high dose, corresponding to the optimal highest safe and efficacious dose selected from Stage 1, injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388447|NCT03598777|OG002|Outcome|Dysport Low Dose|Stage 2: On Cycle 1 Day 1 in the DB treatment period, participants were to receive Dysport low dose, selected based on safety and efficacy considerations observed in Stage 1, injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
11388448|NCT03598777|EG000|Reported Event|Placebo|"Stage 1:~On Cycle 1 Day 1 in the DB treatment period, participants received placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388449|NCT03598777|EG001|Reported Event|Dysport 100 U|"Stage 1:~On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11197422|NCT02170870|OG003|Outcome|Diabetics Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11388450|NCT03598777|EG002|Reported Event|Dysport 300 U|"Stage 1:~On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388451|NCT03598777|EG003|Reported Event|Dysport 400 U|"Stage 1:~On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388452|NCT03598777|EG004|Reported Event|Dysport 500 U|"Stage 1:~On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.~Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety)."
11388453|NCT03406078|BG000|Baseline|Tezepelumab|Tezepelumab 210 mg administered every 4 weeks subcutaneously
11388454|NCT03406078|BG001|Baseline|Placebo|Placebo administered every 4 weeks subcutaneously
11388455|NCT03406078|BG002|Baseline|Total|Total of all reporting groups
11388456|NCT03406078|FG000|Participant Flow|Tezepelumab|Tezepelumab 210 mg administered every 4 weeks subcutaneously
11388457|NCT03406078|FG001|Participant Flow|Placebo|Placebo administered every 4 weeks subcutaneously
11388458|NCT03406078|OG000|Outcome|Tezepelumab|Tezepelumab 210 mg administered every 4 weeks subcutaneously
11388459|NCT03406078|OG001|Outcome|Placebo|Placebo administered every 4 weeks subcutaneously
11388460|NCT03406078|EG000|Reported Event|Tezepelumab|Tezepelumab 210 mg administered every 4 weeks subcutaneously
11388461|NCT03406078|EG001|Reported Event|Placebo|Placebo administered every 4 weeks subcutaneously
11388462|NCT03397589|BG000|Baseline|CHW Arm|"The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.~Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families."
11388463|NCT03397589|BG001|Baseline|Wait-list Control Arm|This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
11197423|NCT02170870|EG000|Reported Event|Healthy Controls Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11388464|NCT03397589|BG002|Baseline|Total|Total of all reporting groups
11388465|NCT03397589|FG000|Participant Flow|CHW Arm|"The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.~Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families."
11388466|NCT03397589|FG001|Participant Flow|Wait-list Control Arm|This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
11388467|NCT03397589|OG000|Outcome|CHW Arm|"The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.~Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families."
11388468|NCT03397589|OG001|Outcome|Wait-list Control Arm|This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
11388469|NCT03397589|EG000|Reported Event|CHW Arm|"The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.~Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families."
11388470|NCT03397589|EG001|Reported Event|Wait-list Control Arm|This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
11388471|NCT03368066|BG000|Baseline|Hospitalized Cirrhosis Patients|"Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency~Cosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency"
11388472|NCT03368066|FG000|Participant Flow|Normal Adrenal Response|Delta cortisol response to 250mcg Cosyntropin > 9 micrograms/dL
11388473|NCT03368066|FG001|Participant Flow|Relative Adrenal Insufficiency|Delta cortisol response to 250mcg Cosyntropin < 9 micrograms/dL
11388474|NCT03368066|OG000|Outcome|Normal Adrenal Response|Delta cortisol response to 250mcg Cosyntropin > 9 micrograms/dL
11388475|NCT03368066|OG001|Outcome|Relative Adrenal Insufficiency|Delta cortisol response to 250mcg Cosyntropin < 9 micrograms/dL
11388476|NCT03368066|OG000|Outcome|Hospitalized Cirrhosis Patients|"Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency~Cosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency"
11388477|NCT03368066|EG000|Reported Event|Hospitalized Cirrhosis Patients|"Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency~Cosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency"
11388478|NCT03345342|BG000|Baseline|Open-Label (OL) PP1M/PP3M|Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.
11388479|NCT03345342|FG000|Participant Flow|Open-Label (OL) PP1M/PP3M|Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.
11388480|NCT03345342|FG001|Participant Flow|Double-blind PP3M|Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.
11388481|NCT03345342|FG002|Participant Flow|Double-blind PP6M|Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
11197424|NCT02170870|EG001|Reported Event|Healthy Controls Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11197425|NCT02170870|EG002|Reported Event|Diabetics Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11388482|NCT03345342|FG003|Participant Flow|Follow-up (FU) Phase PP3M|Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
11388483|NCT03345342|FG004|Participant Flow|Follow-up Phase PP6M|Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
11388484|NCT03345342|OG000|Outcome|DB PP3M|Participants received 4 doses of PP3M (350 or 525 milligrams equivalent [mg eq.]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.
11388485|NCT03345342|OG001|Outcome|DB PP6M|Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
11388486|NCT03345342|OG000|Outcome|DB PP3M|Participants received 4 doses of PP3M (350 or 525 mg eq.) IM injection for up to 12 months (1 dose every 3 month) during DB phase.
11388487|NCT03345342|OG000|Outcome|Double-blind (DB) PP3M|Participants received 4 doses of PP3M (350 or 525 mg eq.) IM injection for up to 12 months (1 dose every 3 month) during DB phase.
11388488|NCT03345342|OG001|Outcome|Double-blind (DB) PP6M|Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
11388489|NCT03345342|EG000|Reported Event|Open-Label (OL) PP1M/PP3M|Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.
11388490|NCT03345342|EG001|Reported Event|Double-blind PP3M|Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.
11388491|NCT03345342|EG002|Reported Event|Double-blind PP6M|Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
11388492|NCT03345342|EG003|Reported Event|Follow-up (FU) Phase PP3M|Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
11388493|NCT03345342|EG004|Reported Event|Follow-up Phase PP6M|Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
11388494|NCT03218995|BG000|Baseline|Overall Study|Eteplirsen was administered once every 7 days by IV infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388495|NCT03218995|FG000|Participant Flow|Eteplirsen|Eteplirsen was administered once every 7 days by intravenous (IV) infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 milligrams/kilogram (mg/kg) eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388496|NCT03218995|OG000|Outcome|Cohort 1: Age 24 to 48 Months|Participants aged 24 to 48 months old were administered eteplirsen once every 7 days by IV infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388497|NCT03218995|OG001|Outcome|Cohort 2: Age 6 to <24 Months|Participants aged 6 to <24 months old were administered eteplirsen once every 7 days by IV infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388498|NCT03218995|EG000|Reported Event|Cohort 1: Age 24 to 48 Months|Participants aged 24 to 48 months old were administered eteplirsen once every 7 days by IV infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388499|NCT03218995|EG001|Reported Event|Cohort 2: Age 6 to <24 Months|Participants aged 6 to <24 months old were administered eteplirsen once every 7 days by IV infusion starting on Day 1 for up to 96 weeks. The starting dose was 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg for 10 weeks, and then participants continued to receive eteplirsen at 30 mg/kg for the duration of the study.
11388500|NCT03030222|BG000|Baseline|Empagliflozin|"Empagliflozin 10 mg tab, once daily, for 12 weeks~Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab"
11388501|NCT03030222|BG001|Baseline|Placebo|"Empagliflozin matching placebo oral tablet, once daily for 12 weeks~Placebo Oral Tablet: Empagliflozin matching placebo"
11388502|NCT03030222|BG002|Baseline|Total|Total of all reporting groups
11388503|NCT03030222|FG000|Participant Flow|Empagliflozin|"Empagliflozin 10 mg tab, once daily, for 12 weeks~Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab"
11388504|NCT03030222|FG001|Participant Flow|Placebo|"Empagliflozin matching placebo oral tablet, once daily for 12 weeks~Placebo Oral Tablet: Empagliflozin matching placebo"
11388505|NCT03030222|OG000|Outcome|Empagliflozin|"Empagliflozin 10 mg tab, once daily, for 12 weeks~Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab"
11388506|NCT03030222|OG001|Outcome|Placebo|"Empagliflozin matching placebo oral tablet, once daily for 12 weeks~Placebo Oral Tablet: Empagliflozin matching placebo"
11388507|NCT03030222|EG000|Reported Event|Empagliflozin|"Empagliflozin 10 mg tab, once daily, for 12 weeks~Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab"
11388508|NCT03030222|EG001|Reported Event|Placebo|"Empagliflozin matching placebo oral tablet, once daily for 12 weeks~Placebo Oral Tablet: Empagliflozin matching placebo"
11388509|NCT02880241|BG000|Baseline|Cohort 1A - P. Vivax Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388510|NCT02880241|BG001|Baseline|Cohort 1B - P. Falciparum Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388511|NCT02880241|BG002|Baseline|Cohort 2A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388512|NCT02880241|BG003|Baseline|Cohort 2B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388513|NCT02880241|BG004|Baseline|Cohort 3A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388514|NCT02880241|BG005|Baseline|Cohort 3B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388515|NCT02880241|BG006|Baseline|Total|Total of all reporting groups
11388516|NCT02880241|FG000|Participant Flow|Cohort 1A - P. Vivax Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388517|NCT02880241|FG001|Participant Flow|Cohort 1B - P. Falciparum Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388518|NCT02880241|FG002|Participant Flow|Cohort 2A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388519|NCT02880241|FG003|Participant Flow|Cohort 2B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388520|NCT02880241|FG004|Participant Flow|Cohort 3A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388521|NCT02880241|FG005|Participant Flow|Cohort 3B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388522|NCT02880241|OG000|Outcome|Cohort 1B - P. Falciparum Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388523|NCT02880241|OG001|Outcome|Cohort 1A - P. Vivax Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388524|NCT02880241|OG002|Outcome|Cohort 2A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388525|NCT02880241|OG003|Outcome|Cohort 2B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388526|NCT02880241|OG004|Outcome|Cohort 3A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388527|NCT02880241|OG005|Outcome|Cohort 3B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388528|NCT02880241|OG000|Outcome|Cohort 1A - P. Vivax Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388529|NCT02880241|OG001|Outcome|Cohort 1B - P. Falciparum Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388530|NCT02880241|EG000|Reported Event|Cohort 1B - P. Falciparum Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388531|NCT02880241|EG001|Reported Event|Cohort 1A - P. Vivax Malaria|"A single oral dose of up to 120mg MMV390048~MMV390048: Tablets of 20mg each"
11388532|NCT02880241|EG002|Reported Event|Cohort 2A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388533|NCT02880241|EG003|Reported Event|Cohort 2B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388534|NCT02880241|EG004|Reported Event|Cohort 3A - P. Vivax Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388535|NCT02880241|EG005|Reported Event|Cohort 3B - P. Falciparum Malaria|"A single oral dose (to be determined) of MMV390048~MMV390048: Tablets of 20mg each"
11388536|NCT02832687|BG000|Baseline|Normal Saline|"Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.~normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL"
11388537|NCT02832687|BG001|Baseline|Acetaminophen|"Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline~Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours."
11388538|NCT02832687|BG002|Baseline|Total|Total of all reporting groups
11388539|NCT02832687|FG000|Participant Flow|Normal Saline|"Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.~normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL"
11388540|NCT02832687|FG001|Participant Flow|Acetaminophen|"Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline~Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours."
11388541|NCT02832687|OG000|Outcome|Normal Saline|"Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.~normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL"
11388542|NCT02832687|OG001|Outcome|Acetaminophen|"Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline~Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours."
11388543|NCT02832687|EG000|Reported Event|Normal Saline|"Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.~normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL"
11388544|NCT02832687|EG001|Reported Event|Acetaminophen|"Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline~Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours."
11388545|NCT02568449|BG000|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11388546|NCT02568449|FG000|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11388547|NCT02568449|OG000|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11388548|NCT02568449|EG000|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nintedanib: Given PO"
11388549|NCT02499900|BG000|Baseline|Copaxone® 20 mg/mL QD|Subcutaneous Injections 20 mg/mL daily (QD) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11388550|NCT02499900|BG001|Baseline|Copaxone® 40 mg/mL TIW|Subcutaneous Injections 40 mg/mL three times a week (TIW) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11388551|NCT02499900|BG002|Baseline|Total|Total of all reporting groups
11388552|NCT02499900|FG000|Participant Flow|Copaxone® 20 mg/mL QD|Subcutaneous Injections 20 mg/mL daily (QD) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11388553|NCT02499900|FG001|Participant Flow|Copaxone® 40 mg/mL TIW|Subcutaneous Injections 40 mg/mL three times a week (TIW) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11388554|NCT02499900|OG000|Outcome|Copaxone® 20 mg/mL QD|Subcutaneous Injections 20 mg/mL daily (QD) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11388555|NCT02499900|OG001|Outcome|Copaxone® 40 mg/mL TIW|Subcutaneous Injections 40 mg/mL three times a week (TIW) for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
11197426|NCT02170870|EG003|Reported Event|Diabetics Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11388556|NCT02499900|OG000|Outcome|Copaxone® 20 mg/mL QD (Core)|Subcutaneous injections of Copaxone 20 mg/mL daily (QD) for the core period from Day 1 to Month 6.
11340553|NCT03657407|OG000|Outcome|Belladonna & Opium|"29 women randomized to Belladonna & Opium suppository~Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository"
11340554|NCT03657407|OG001|Outcome|Placebo|"27 women randomized to Glycerin suppository~Glycerin Suppository: Glycerine rectal suppository"
11340555|NCT03657407|EG000|Reported Event|Belladonna & Opium|"29 women randomized to Belladonna & Opium suppository~Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository"
11340556|NCT03657407|EG001|Reported Event|Placebo|"27 women randomized to Glycerin suppository~Glycerin Suppository: Glycerine rectal suppository"
11340557|NCT03658811|BG000|Baseline|Upper Eyelid Meibomian Gland Dysfunction|"Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments~intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose"
11340558|NCT03658811|FG000|Participant Flow|Upper Eyelid Meibomian Gland Dysfunction|"Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments~intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose"
11340559|NCT03658811|OG000|Outcome|Upper Eyelid Meibomian Gland Dysfunction|"Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments~intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose"
11340560|NCT03658811|EG000|Reported Event|Upper Eyelid Meibomian Gland Dysfunction|"Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments~intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose"
11340561|NCT03658876|BG000|Baseline|Iron Group|Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
11340562|NCT03658876|BG001|Baseline|EPO Group|Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
11340563|NCT03658876|BG002|Baseline|Total|Total of all reporting groups
11340564|NCT03658876|FG000|Participant Flow|Iron Group|Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
11340565|NCT03658876|FG001|Participant Flow|EPO Group|Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
11340566|NCT03658876|OG000|Outcome|EPO Group|Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
11340567|NCT03658876|OG001|Outcome|Iron Group|Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
11340568|NCT03658876|EG000|Reported Event|Iron Group|Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions
11340569|NCT03658876|EG001|Reported Event|EPO Group|Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
11340570|NCT03658889|BG000|Baseline|Patients Under Treatment(s) for GCA|Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
11340571|NCT03658889|BG001|Baseline|Physicians|Physicians who recruited the patients with Giant Cell Arteritis (GCA)
11340572|NCT03658889|BG002|Baseline|Total|Total of all reporting groups
11340573|NCT03658889|FG000|Participant Flow|Patients Under Treatment(s) for GCA|Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
11340574|NCT03658889|FG001|Participant Flow|Physicians|Physicians who recruited the patients with Giant Cell Arteritis (GCA)
11340575|NCT03658889|OG000|Outcome|Patients Under Treatment(s) for GCA|Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
11340576|NCT03658889|OG000|Outcome|Physician Population|Physicians who recruited the patients with Giant Cell Arteritis (GCA)
11340577|NCT03658889|EG000|Reported Event|Patients Under Treatment(s) for GCA|Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
11340578|NCT03660787|BG000|Baseline|Placebo, 1.5 mL/kg|"each subject received the placebo at the dose of 1.5 mL/kg of body weight;~Placebo: Saline"
11340579|NCT03660787|BG001|Baseline|Placebo, 2.4 mL/kg|"each subject received the placebo at the dose of 2.4 mL/kg of body weight;~Placebo: Saline"
11340580|NCT03660787|BG002|Baseline|Seroguard, 1.5 mL/kg|"each subject received the test drug at the dose of 1.5 mL/kg of body weight;~Seroguard: Seroguard 0.41 g/L solution"
11340581|NCT03660787|BG003|Baseline|Seroguard, 2.4 mL/kg|"each subject received the test drug at the dose of 2.4 mL/kg of body weight.~Seroguard: Seroguard 0.41 g/L solution"
11340582|NCT03660787|BG004|Baseline|Total|Total of all reporting groups
11340583|NCT03660787|FG000|Participant Flow|Placebo, 1.5 mL/kg|"each subject received the placebo at the dose of 1.5 mL/kg of body weight;~Placebo: Saline"
11340584|NCT03660787|FG001|Participant Flow|Placebo, 2.4 mL/kg|"each subject received the placebo at the dose of 2.4 mL/kg of body weight;~Placebo: Saline"
11340585|NCT03660787|FG002|Participant Flow|Seroguard, 1.5 mL/kg|"each subject received the test drug at the dose of 1.5 mL/kg of body weight;~Seroguard: Seroguard 0.41 g/L solution"
11340586|NCT03660787|FG003|Participant Flow|Seroguard, 2.4 mL/kg|"each subject received the test drug at the dose of 2.4 mL/kg of body weight.~Seroguard: Seroguard 0.41 g/L solution"
11340587|NCT03660787|OG000|Outcome|Placebo, 1.5 mL/kg|"each subject received the placebo at the dose of 1.5 mL/kg of body weight;~Placebo: Saline"
11340588|NCT03660787|OG001|Outcome|Placebo, 2.4 mL/kg|"each subject received the placebo at the dose of 2.4 mL/kg of body weight;~Placebo: Saline"
11340589|NCT03660787|OG002|Outcome|Seroguard, 1.5 mL/kg|"each subject received the test drug at the dose of 1.5 mL/kg of body weight;~Seroguard: Seroguard 0.41 g/L solution"
11340590|NCT03660787|OG003|Outcome|Seroguard, 2.4 mL/kg|"each subject received the test drug at the dose of 2.4 mL/kg of body weight.~Seroguard: Seroguard 0.41 g/L solution"
11340591|NCT03660787|EG000|Reported Event|Placebo, 1.5 mL/kg|"each subject received the placebo at the dose of 1.5 mL/kg of body weight;~Placebo: Saline"
11340592|NCT03660787|EG001|Reported Event|Placebo, 2.4 mL/kg|"each subject received the placebo at the dose of 2.4 mL/kg of body weight;~Placebo: Saline"
11340593|NCT03660787|EG002|Reported Event|Seroguard, 1.5 mL/kg|"each subject received the test drug at the dose of 1.5 mL/kg of body weight;~Seroguard: Seroguard 0.41 g/L solution"
11340594|NCT03660787|EG003|Reported Event|Seroguard, 2.4 mL/kg|"each subject received the test drug at the dose of 2.4 mL/kg of body weight.~Seroguard: Seroguard 0.41 g/L solution"
11340595|NCT03661346|BG000|Baseline|Esmolol|"Patients receiving esmolol when intra-operative MAP > 80 mmHg.~Esmolol: Infusion - 0.1mg/kg/min~• Maximum Dose - after 30 minutes, 0.3mg/kg/min"
11340596|NCT03661346|BG001|Baseline|Labetalol|"Patients receiving labetalol when intra-operative MAP > 80 mmHg~Labetalol: Aliquots of 20mg of Labetol~• Maximum Dose - 300mg total for case"
11340597|NCT03661346|BG002|Baseline|Total|Total of all reporting groups
11340598|NCT03661346|FG000|Participant Flow|Esmolol|"Patients receiving esmolol when intra-operative MAP > 80 mmHg.~Esmolol: Infusion - 0.1mg/kg/min~• Maximum Dose - after 30 minutes, 0.3mg/kg/min"
11340599|NCT03661346|FG001|Participant Flow|Labetalol|"Patients receiving labetalol when intra-operative MAP > 80 mmHg~Labetalol: Aliquots of 20mg of Labetol~• Maximum Dose - 300mg total for case"
11340600|NCT03661346|OG000|Outcome|Esmolol|"Patients receiving esmolol when intra-operative MAP > 80 mmHg.~Esmolol: Infusion - 0.1mg/kg/min~• Maximum Dose - after 30 minutes, 0.3mg/kg/min"
11340601|NCT03661346|OG001|Outcome|Labetalol|"Patients receiving labetalol when intra-operative MAP > 80 mmHg~Labetalol: Aliquots of 20mg of Labetol~• Maximum Dose - 300mg total for case"
11340602|NCT03661346|EG000|Reported Event|Esmolol|"Patients receiving esmolol when intra-operative MAP > 80 mmHg.~Esmolol: Infusion - 0.1mg/kg/min~• Maximum Dose - after 30 minutes, 0.3mg/kg/min"
11340603|NCT03661346|EG001|Reported Event|Labetalol|"Patients receiving labetalol when intra-operative MAP > 80 mmHg~Labetalol: Aliquots of 20mg of Labetol~• Maximum Dose - 300mg total for case"
11340604|NCT03661541|BG000|Baseline|6 or More Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11340605|NCT03661541|BG001|Baseline|1 or 2 Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340606|NCT03661541|BG002|Baseline|Zero Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group C: 12 subjects with zero outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340607|NCT03661541|BG003|Baseline|Total|Total of all reporting groups
11340608|NCT03661541|FG000|Participant Flow|6 or More Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11340609|NCT03661541|FG001|Participant Flow|1 to 2 Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340610|NCT03661541|FG002|Participant Flow|Zero Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group C: 12 subjects with zero outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340611|NCT03661541|OG000|Outcome|Group A: 6 or More Herpes Labialis Outbreaks, Day 1|"Group A: 12 subjects positive for Ab against HSV-1 and self-reporting 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples on day 1 are obtained. Group A subjects had blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11388557|NCT02499900|OG001|Outcome|Copaxone® 40 mg/mL TIW (Core)|Subcutaneous injections of Copaxone 40 mg/mL three times a week (TIW) for the core period from Day 1 to Month 6.
11388558|NCT02499900|OG002|Outcome|Copaxone® 40 mg/mL TIW (Switch-Extension)|Participants who were administered daily Copaxone 20 mg/mL daily injections during the core period, were switched to 40 mg/mL three times a week (TIW) injections for the extension period (Months 7-12)
11388559|NCT02499900|OG003|Outcome|Copaxone® 40 mg/mL TIW (Extension)|Participants who were administered Copaxone 40 mg/mL three times a week (TIW) injections during the core period, continued Copaxone at that same dosage for the extension period (Months 7-12)
11388560|NCT02499900|EG000|Reported Event|Copaxone® 20 mg/mL QD (Core)|Subcutaneous injections of Copaxone 20 mg/mL daily (QD) for the core period from Day 1 to Month 6.
11388561|NCT02499900|EG001|Reported Event|Copaxone® 40 mg/mL TIW (Core)|Subcutaneous injections of Copaxone 40 mg/mL three times a week (TIW) for the core period from Day 1 to Month 6.
11388562|NCT02499900|EG002|Reported Event|Copaxone® 40 mg/mL TIW (Switch-Extension)|Participants who were administered daily Copaxone 20 mg/mL daily injections during the core period, were switched to 40 mg/mL three times a week (TIW) injections for the extension period (Months 7-12)
11388563|NCT02499900|EG003|Reported Event|Copaxone® 40 mg/mL TIW (Extension)|Participants who were administered Copaxone 40 mg/mL three times a week (TIW) injections during the core period, continued Copaxone at that same dosage for the extension period (Months 7-12)
11388564|NCT02481986|BG000|Baseline|Community Health Worker|"Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.~Community Health Worker: A community health worker is para-professional who performs education, case management, and social support."
11388565|NCT02481986|BG001|Baseline|Certified Asthma Educator|"Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.~Certified asthma educator: A certified asthma educator has is certified and performs asthma education."
11388566|NCT02481986|BG002|Baseline|Total|Total of all reporting groups
11388567|NCT02481986|FG000|Participant Flow|Community Health Worker|"Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.~Community Health Worker: A community health worker is para-professional who performs education, case management, and social support."
11388568|NCT02481986|FG001|Participant Flow|Certified Asthma Educator|"Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.~Certified asthma educator: A certified asthma educator has is certified and performs asthma education."
11388569|NCT02481986|OG000|Outcome|Community Health Worker|"Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.~Community Health Worker: A community health worker is para-professional who performs education, case management, and social support."
11388570|NCT02481986|OG001|Outcome|Certified Asthma Educator|"Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.~Certified asthma educator: A certified asthma educator has is certified and performs asthma education."
11388571|NCT02481986|EG000|Reported Event|Community Health Worker|"Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.~Community Health Worker: A community health worker is para-professional who performs education, case management, and social support."
11388572|NCT02481986|EG001|Reported Event|Certified Asthma Educator|"Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.~Certified asthma educator: A certified asthma educator has is certified and performs asthma education."
11388573|NCT02394548|BG000|Baseline|Contralateral Esophagus Sparing Technique (CEST)|"IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen)~Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis"
11388574|NCT02394548|FG000|Participant Flow|Contralateral Esophagus Sparing Technique (CEST)|"IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen)~Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis"
11388575|NCT02394548|OG000|Outcome|Contralateral Esophagus Sparing Technique (CEST)|"IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen)~Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis"
11388576|NCT02394548|EG000|Reported Event|Contralateral Esophagus Sparing Technique (CEST)|"IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen)~Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis"
11388577|NCT02269917|BG000|Baseline|D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])|Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
11388578|NCT02269917|BG001|Baseline|Control (Baseline to Switch)|Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
11388579|NCT02269917|BG002|Baseline|Total|Total of all reporting groups
11388580|NCT02269917|FG000|Participant Flow|D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])|Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
11388581|NCT02269917|FG001|Participant Flow|Control (Baseline to Switch)|Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
11388582|NCT02269917|FG002|Participant Flow|Switch to D/C/F/TAF|After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
11388583|NCT02269917|OG000|Outcome|D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])|Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available up to 42 months (end of extension).
11388584|NCT02269917|OG001|Outcome|Control (Baseline to Switch)|Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
11388585|NCT02269917|OG001|Outcome|Switch to D/C/F/TAF|After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
11388586|NCT02269917|OG002|Outcome|Switch to D/C/F/TAF|After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF treatment up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until D/C/F/TAF became commercially available for up to 42 months.
11388587|NCT02269917|EG000|Reported Event|D/C/F/TAF (Test) (Baseline to End of Extension [EOE])|Participants received a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily up to Week 48. After Week 48, all participants continued to receive D/C/F/TAF treatment (that is, initial switch to D/C/F/TAF group) up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF became commercially available up to 42 months
11388588|NCT02269917|EG001|Reported Event|Control (Baseline to Switch)|Participants received a boosted protease inhibitor (bPI) (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) up to Week 48.
11197427|NCT02170870|EG004|Reported Event|Functional Dyspepsia Exendin 9-39|"Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).~Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)."
11197428|NCT02170870|EG005|Reported Event|Functional Dyspepsia Placebo|Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
11388589|NCT02269917|EG002|Reported Event|Switch to D/C/F/TAF Group|After Week 52, participants earlier receiving treatment with bPI+F/TDF switched to D/C/F/TAF up to Week 96. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF became commercially available for up to 42 months.
11388590|NCT02225366|BG000|Baseline|Cohort 1|This cohort received starting dose of 250 ug/tumor injection once a week
11388591|NCT02225366|BG001|Baseline|Cohort 2|This cohort received 500 ug/tumor injection once a week
11388592|NCT02225366|BG002|Baseline|Total|Total of all reporting groups
11388593|NCT02225366|FG000|Participant Flow|Cohort 1|This cohort received starting dose of 250 ug/tumor injection once a week
11388594|NCT02225366|FG001|Participant Flow|Cohort 2|This cohort received 500 ug/tumor injection once a week
11388595|NCT02225366|OG000|Outcome|Cohort 1|This cohort received starting dose of 250 ug/tumor injection once a week
11388596|NCT02225366|OG001|Outcome|Cohort 2|This cohort received 500 ug/tumor injection once a week
11388597|NCT02225366|EG000|Reported Event|Cohort 1|This cohort received starting dose of 250 ug/tumor injection once a week
11388598|NCT02225366|EG001|Reported Event|Cohort 2|This cohort received 500 ug/tumor injection once a week
11388599|NCT01530997|BG000|Baseline|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
11388600|NCT01530997|FG000|Participant Flow|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
11388601|NCT01530997|OG000|Outcome|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
11388602|NCT01530997|OG000|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
11388603|NCT01530997|OG000|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
11388604|NCT01530997|OG001|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
11388605|NCT01530997|OG002|Outcome|Post-Surgery|This data was collected at the first follow-up post-surgery.
11388606|NCT01530997|OG002|Outcome|Post-Surgery|This data was collected at the first follow-up post surgery.
11388607|NCT01530997|OG000|Outcome|Pre-treatment|This data was collected before the treatment.
11388608|NCT01530997|OG001|Outcome|Post-treatment|This data was collected 4-8 weeks after chemoradiation therapy
11388609|NCT01530997|EG000|Reported Event|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.~Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively"
11388610|NCT01109004|BG000|Baseline|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388611|NCT01109004|BG001|Baseline|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388612|NCT01109004|BG002|Baseline|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388613|NCT01109004|BG003|Baseline|Total|Total of all reporting groups
11388614|NCT01109004|FG000|Participant Flow|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388615|NCT01109004|FG001|Participant Flow|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388616|NCT01109004|FG002|Participant Flow|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388617|NCT01109004|OG000|Outcome|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388618|NCT01109004|OG001|Outcome|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388619|NCT01109004|OG002|Outcome|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388620|NCT01109004|EG000|Reported Event|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388621|NCT01109004|EG001|Reported Event|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11388622|NCT01109004|EG002|Reported Event|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms."
11197429|NCT02171065|BG000|Baseline|Guideline Directed Medical Therapy (GDMT) in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.
11197430|NCT02171065|BG001|Baseline|ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.
11197431|NCT02171065|BG002|Baseline|PROSPECT II Only|Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
11388623|NCT01067521|BG000|Baseline|Early Start: GA 40 mg / GA 40 mg|Participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended.
11388624|NCT01067521|BG001|Baseline|Delayed Start: Placebo / GA 40 mg|Participants were administered placebo subcutaneous injections three times a week for 12 months during the double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week during the Open-Label Period from Month 13 up to Year 6.5 until the study ended.
11388625|NCT01067521|BG002|Baseline|Total|Total of all reporting groups
11388626|NCT01067521|FG000|Participant Flow|Early Start: GA 40 mg / GA 40 mg|Participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended.
11388627|NCT01067521|FG001|Participant Flow|Delayed Start: Placebo / GA 40 mg|Participants were administered placebo subcutaneous injections three times a week for 12 months during the double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week during the Open-Label Period from Month 13 up to Year 6.5 until the study ended.
11388628|NCT01067521|OG000|Outcome|Early Start: GA 40 mg / GA 40 mg|Participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended.
11388629|NCT01067521|OG001|Outcome|Delayed Start: Placebo / GA 40 mg|Participants were administered placebo subcutaneous injections three times a week for 12 months during the double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week during the Open-Label Period from Month 13 up to Year 6.5 until the study ended.
11388630|NCT01067521|OG000|Outcome|Early Start: GA 40 mg / GA 40 mg|RParticipants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended.
11388631|NCT01067521|OG000|Outcome|Early Start: GA 40 mg / GA 40 mg|Participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended
11388632|NCT01067521|OG001|Outcome|Delayed Start: GA 40 mg|After completing the double-blind Placebo-Controlled Period, participants had the option of continuing in the study on glatiramer acetate (GA) 40 mg/ml by subcutaneous injection three times a week until the study ended. This 'Delayed Start' treatment began at Month 13 and continued until the study ended (up to about 6.5 years).
11388633|NCT01067521|OG002|Outcome|Delayed Start: Placebo|Participants were administered placebo subcutaneous injections three times a week from Day 1 to Month 12 during the double-blind Placebo-Controlled Period.
11388634|NCT01067521|EG000|Reported Event|Delayed Start: GA 40 mg|After completing the double-blind Placebo-Controlled Period, participants had the option of continuing in the study on glatiramer acetate (GA) 40 mg/ml by subcutaneous injection three times a week until the study ended. This 'Delayed Start' treatment started at Month 13 and continued until the study ended (up to about 6.5 years).
11388635|NCT01067521|EG001|Reported Event|Delayed Start: Placebo|Participants were administered placebo subcutaneous injections three times a week from Day 1 to Month 12 during the double-blind Placebo-Controlled Period.
11388636|NCT01067521|EG002|Reported Event|Early Start: GA 40 mg / GA 40 mg|Participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the double-blind Placebo-Controlled Period, and then continued that treatment in the Open-label Period from Month 13 up to Year 6.5 until the study ended
11388637|NCT01047319|BG000|Baseline|Early Laquinimod|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388638|NCT01047319|BG001|Baseline|Switch From Placebo|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months."
11388639|NCT01047319|BG002|Baseline|Switch From Avonex|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months."
11388640|NCT01047319|BG003|Baseline|Total|Total of all reporting groups
11388641|NCT01047319|FG000|Participant Flow|Early Laquinimod|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388642|NCT01047319|FG001|Participant Flow|Switch From Placebo|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months."
11388643|NCT01047319|FG002|Participant Flow|Switch From Avonex|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months."
11388644|NCT01047319|OG000|Outcome|Early Laquinimod|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388645|NCT01047319|OG001|Outcome|Switch From Placebo|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months."
11388646|NCT01047319|OG002|Outcome|Switch From Avonex|"All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months."
11388647|NCT01047319|EG000|Reported Event|Early Laquinimod|"All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388648|NCT01047319|EG001|Reported Event|Switch From Placebo|"All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from Placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months."
11388649|NCT01047319|EG002|Reported Event|Switch From Avonex|All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
11388650|NCT00988052|BG000|Baseline|Early Laquinimod|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388651|NCT00988052|BG001|Baseline|Switch From Placebo|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months."
11388652|NCT00988052|BG002|Baseline|Total|Total of all reporting groups
11388653|NCT00988052|FG000|Participant Flow|Early Laquinimod|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388654|NCT00988052|FG001|Participant Flow|Switch From Placebo|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months."
11388655|NCT00988052|OG000|Outcome|Early Laquinimod|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388656|NCT00988052|OG001|Outcome|Switch From Placebo|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months."
11388657|NCT00988052|EG000|Reported Event|Early Laquinimod 0.6 mg|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Early laquinimod subgroup included participants in MS-LAQ-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months."
11388658|NCT00988052|EG001|Reported Event|Switch From Placebo to Laquinimod 0.6 mg|"All participants in MS-LAQ-301E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.~The Switch from placebo subgroup included participants in MS-LAQ-301 double-blind study who were administered placebo daily for 24 months."
11388659|NCT02021773|BG000|Baseline|Placebo|Participants received subcutaneous placebo injections at one visit per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388660|NCT02021773|BG001|Baseline|LBR-101 Low Dose|Participants received one subcutaneous loading dose of 675 mg LBR-101 (fremanezumab) on Day 1/week 0 followed by one subcutaneous dose of 225 mg LBR-101 (fremanezumab) once per month for two months (Day 29/week 4 and Day 57/week 8).
11388661|NCT02021773|BG002|Baseline|LBR-101 High Dose|Participants received one subcutaneous dose of 900 mg LBR-101 (fremanezumab) once per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388662|NCT02021773|BG003|Baseline|Total|Total of all reporting groups
11388663|NCT02021773|FG000|Participant Flow|Placebo|Participants received subcutaneous placebo injections at one visit per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388664|NCT02021773|FG001|Participant Flow|LBR-101 Low Dose|Participants received one subcutaneous loading dose of 675 mg LBR-101 (fremanezumab) on Day 1/week 0 followed by one subcutaneous dose of 225 mg LBR-101 (fremanezumab) once per month for two months (Day 29/week 4 and Day 57/week 8).
11388665|NCT02021773|FG002|Participant Flow|LBR-101 High Dose|Participants received one subcutaneous dose of 900 mg LBR-101 (fremanezumab) once per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388666|NCT02021773|OG000|Outcome|Placebo|Participants received subcutaneous placebo injections at one visit per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388667|NCT02021773|OG001|Outcome|LBR-101 Low Dose|Participants received one subcutaneous loading dose of 675 mg LBR-101 (fremanezumab) on Day 1/week 0 followed by one subcutaneous dose of 225 mg LBR-101 (fremanezumab) once per month for two months (Day 29/week 4 and Day 57/week 8).
11388668|NCT02021773|OG002|Outcome|LBR-101 High Dose|Participants received one subcutaneous dose of 900 mg LBR-101 (fremanezumab) once per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388669|NCT02021773|EG000|Reported Event|Placebo|Participants received subcutaneous placebo injections at one visit per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388670|NCT02021773|EG001|Reported Event|LBR-101 Low Dose|Participants received one subcutaneous loading dose of 675 mg LBR-101 (fremanezumab) on Day 1/week 0 followed by one subcutaneous dose of 225 mg LBR-101 (fremanezumab) once per month for two months (Day 29/week 4 and Day 57/week 8).
11388671|NCT02021773|EG002|Reported Event|LBR-101 High Dose|Participants received one subcutaneous dose of 900 mg LBR-101 (fremanezumab) once per month for three months (Day 1/week 0, Day 29/week 4, and Day 57/week 8).
11388672|NCT04689932|BG000|Baseline|Pre- Dialyzer Infusion and Post- Dialyzer Infusion|"On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line. On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.~Triferic AVNU: Ferric Pyrophosphate Citrate"
11388673|NCT04689932|FG000|Participant Flow|Pre- Dialyzer Infusion and Post- Dialyzer Infusion|"On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line. On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.~Triferic AVNU: Ferric Pyrophosphate Citrate"
11388674|NCT04689932|OG000|Outcome|Pre- Dialyzer Infusion and Post- Dialyzer Infusion|"On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line. On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.~Triferic AVNU: Ferric Pyrophosphate Citrate"
11388675|NCT04689932|EG000|Reported Event|Pre- Dialyzer Infusion|"On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line.~Triferic AVNU: Ferric Pyrophosphate Citrate"
11388676|NCT04689932|EG001|Reported Event|Post- Dialyzer Infusion|"On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.~Triferic AVNU: Ferric Pyrophosphate Citrate"
11388677|NCT04635579|BG000|Baseline|Anterior Cruciate Ligament Reconstruction Group|"Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388678|NCT04635579|BG001|Baseline|Control Group|"Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388679|NCT04635579|BG002|Baseline|Total|Total of all reporting groups
11388680|NCT04635579|FG000|Participant Flow|Anterior Cruciate Ligament Reconstruction Group|"Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388681|NCT04635579|FG001|Participant Flow|Control Group|"Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388682|NCT04635579|OG000|Outcome|Anterior Cruciate Ligament Reconstruction Group|"Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388683|NCT04635579|OG001|Outcome|Control Group|"Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388684|NCT04635579|EG000|Reported Event|Anterior Cruciate Ligament Reconstruction Group|"Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388685|NCT04635579|EG001|Reported Event|Control Group|"Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries~Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure"
11388686|NCT04553406|BG000|Baseline|SPR720 500 mg|SPR720 500 mg administered orally once daily for 28 days.
11388687|NCT04553406|BG001|Baseline|Placebo|Placebo administered orally once daily for 28 days.
11388688|NCT04553406|BG002|Baseline|Total|Total of all reporting groups
11388689|NCT04553406|FG000|Participant Flow|SPR720 500 mg|SPR720 500 mg administered orally once daily for 28 days.
11388690|NCT04553406|FG001|Participant Flow|Placebo|Placebo administered orally once daily for 28 days.
11388691|NCT04553406|OG000|Outcome|SPR720 500 mg|SPR720 500 mg administered orally once daily for 28 days.
11388692|NCT04553406|OG001|Outcome|Placebo|Placebo administered orally once daily for 28 days.
11388693|NCT04553406|EG000|Reported Event|SPR720 500 mg|SPR720 500 mg administered orally once daily for 28 days.
11388694|NCT04553406|EG001|Reported Event|Placebo|Placebo administered orally once daily for 28 days.
11388695|NCT03792750|BG000|Baseline|BMS-986205 in Combination With Nivolumab|Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles.
11388696|NCT03792750|FG000|Participant Flow|BMS-986205 in Combination With Nivolumab|Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles.
11388697|NCT03792750|OG000|Outcome|BMS-986205 in Combination With Nivolumab|Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles.
11388698|NCT03792750|OG000|Outcome|BMS-986205 Monotherapy and in Combination With Nivolumab|The treatment phase consists of the 2-week monotherapy lead-in (Cycle 0) and up to twelve 4-week combination therapy cycles. The 2-week lead-in treatment consists of a single oral daily dose of BMS-986205. The combination therapy cycles are comprised of an oral daily dose of BMS-986205 and one dose of nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. Total study treatment period is up to 50 weeks
11388699|NCT03792750|EG000|Reported Event|BMS-986205 in Combination With Nivolumab|Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles.
11388700|NCT03739593|BG000|Baseline|AR-1105-CF1 Initial Phase|Single dose of AR-1105-CF1 (dexamethasone 340 mcg) administered as an intravitreal implant into a single eye
11388701|NCT03739593|BG001|Baseline|AR-1105-CF1 Randomization Phase|Single dose of AR-1105-CF1 (dexamethasone 340 mcg) administered as an intravitreal implant into a single eye
11388702|NCT03739593|BG002|Baseline|AR-1105-CF2 Randomization Phase|Single dose of AR-1105-CF2 (dexamethasone, 340 mcg) administered as an intravitreal implant into a single eye
11388703|NCT03739593|BG003|Baseline|Total|Total of all reporting groups
11388704|NCT03739593|FG000|Participant Flow|Initial Phase: AR-1105-CF1|Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388705|NCT03739593|FG001|Participant Flow|Randomization Phase: AR-1105-CF1|Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388706|NCT03739593|FG002|Participant Flow|Randomization Phase: AR-1105-CF2|Single dose of AR- 1105-clinical formulation 2 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388707|NCT03739593|OG000|Outcome|Initial Phase: AR-1105-CF1|Single dose of AR-1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388708|NCT03739593|OG001|Outcome|Randomization Phase: AR-1105-CF1|Single dose of AR-1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388709|NCT03739593|OG002|Outcome|Randomization Phase: AR-1105-CF2|Single dose of AR-1105-clinical formulation 2 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388710|NCT03739593|EG000|Reported Event|Initial Phase: AR-1105-CF1|Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388711|NCT03739593|EG001|Reported Event|Randomization Phase: AR-1105-CF1|Single dose of AR- 1105-clinical formulation 1 (CF1) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388712|NCT03739593|EG002|Reported Event|Randomization Phase: AR-1105-CF2|Single dose of AR- 1105-clinical formulation 1 (CF2) dexamethasone 340 mcg administered as an intravitreal implant into a single eye
11388713|NCT03739138|BG000|Baseline|MK-4621 0.4 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388714|NCT03739138|BG001|Baseline|MK-4621 0.6 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388715|NCT03739138|BG002|Baseline|MK-4621 0.8 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388716|NCT03739138|BG003|Baseline|Total|Total of all reporting groups
11388717|NCT03739138|FG000|Participant Flow|MK-4621 Monotherapy (Arm 1)|Participants were to receive MK-4621 monotherapy once a week (Q1W) during each 21-day cycle for a maximum duration of 6 cycles. No participants were enrolled in this arm.
11388718|NCT03739138|FG001|Participant Flow|MK-4621 0.4 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388719|NCT03739138|FG002|Participant Flow|MK-4621 0.6 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388720|NCT03739138|FG003|Participant Flow|MK-4621 0.8 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388721|NCT03739138|FG004|Participant Flow|Intrahepatic MK-4621 + Pembrolizumab (Arm 3)|Participants were to receive MK-4621 monotherapy via intrahepatic administration on Day 1 only of the first 21-day cycle (run-in phase). After the run-in phase, participants were to receive MK-4621 Q3W in combination with pembrolizumab 200 mg Q3W for a maximum duration of 5 cycles (Cycles 2-6). No participants were enrolled in this arm.
11388722|NCT03739138|OG000|Outcome|MK-4621 0.4 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11197432|NCT02171065|BG003|Baseline|Total|Total of all reporting groups
11388723|NCT03739138|OG001|Outcome|MK-4621 0.6 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388724|NCT03739138|OG002|Outcome|MK-4621 0.8 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388725|NCT03739138|EG000|Reported Event|MK-4621 0.4 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388726|NCT03739138|EG001|Reported Event|MK-4621 0.6 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388727|NCT03739138|EG002|Reported Event|MK-4621 0.8 mg + Pembrolizumab (Arm 2)|Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment.
11388728|NCT03518086|BG000|Baseline|Placebo IV Q4W|Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388729|NCT03518086|BG001|Baseline|300 mg Mirikizumab IV Q4W|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388730|NCT03518086|BG002|Baseline|Total|Total of all reporting groups
11388731|NCT03518086|FG000|Participant Flow|Placebo IV Q4W|Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388732|NCT03518086|FG001|Participant Flow|300 mg Mirikizumab IV Q4W|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388733|NCT03518086|FG002|Participant Flow|Placebo IV Q4W ME2 Cohort|Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388734|NCT03518086|FG003|Participant Flow|300 mg Mirikizumab IV Q4W ME2 Cohort|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388735|NCT03518086|OG000|Outcome|Placebo IV Q4W|Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388736|NCT03518086|OG001|Outcome|300 mg Mirikizumab IV Q4W|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388737|NCT03518086|OG000|Outcome|300 mg Mirikizumab IV Q4W|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388738|NCT03518086|EG000|Reported Event|Placebo IV Q4W|Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388739|NCT03518086|EG001|Reported Event|300 mg Mirikizumab IV Q4W|300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
11388740|NCT03468309|BG000|Baseline|Genecept Assay and G-DIG Decision Tool|"Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis.~Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding or removing medications will be determined by the provider."
11388741|NCT03468309|FG000|Participant Flow|Genecept Assay and G-DIG Decision Tool|"Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis.~Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider."
11388742|NCT03468309|OG000|Outcome|Genecept Assay and G-DIG Decision Tool|"Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis.~Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider."
11388743|NCT03468309|EG000|Reported Event|Genecept Assay and G-DIG Decision Tool|"Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis.~Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding or removing medications will be determined by the provider."
11388744|NCT03347123|BG000|Baseline|Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388745|NCT03347123|BG001|Baseline|Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388746|NCT03347123|BG002|Baseline|Total|Total of all reporting groups
11388747|NCT03347123|FG000|Participant Flow|Phase 1: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388748|NCT03347123|FG001|Participant Flow|Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388749|NCT03347123|FG002|Participant Flow|Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388750|NCT03347123|FG003|Participant Flow|Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388751|NCT03347123|FG004|Participant Flow|Phase 2: Dose Expansion: Treatment Group A: Cohort A1|Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
11388752|NCT03347123|FG005|Participant Flow|Phase 2: Dose Expansion: Treatment Group A: Cohort A2|Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
11388753|NCT03347123|FG006|Participant Flow|Phase 2: Dose Expansion: Treatment Group B: Cohort B1|Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.
11388754|NCT03347123|OG000|Outcome|Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388755|NCT03347123|OG001|Outcome|Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388756|NCT03347123|OG000|Outcome|Phase 2: Dose Expansion: Treatment Group A: Cohort A1|Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
11388757|NCT03347123|OG001|Outcome|Phase 2: Dose Expansion: Treatment Group A: Cohort A2|Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
11388758|NCT03347123|OG002|Outcome|Phase 2: Dose Expansion: Treatment Group B: Cohort B1|Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.
11388759|NCT03347123|OG001|Outcome|Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388760|NCT03347123|EG000|Reported Event|Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388761|NCT03347123|EG001|Reported Event|Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID|Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
11388762|NCT03347123|EG002|Reported Event|Total|Total
11388763|NCT03318523|BG000|Baseline|PC Period: Placebo|Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388764|NCT03318523|BG001|Baseline|PC Period: BIIB054 250 mg (Early Start)|Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388765|NCT03318523|BG002|Baseline|PC Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388766|NCT03318523|BG003|Baseline|PC Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388767|NCT03318523|BG004|Baseline|Total|Total of all reporting groups
11388768|NCT03318523|FG000|Participant Flow|PC Period: Placebo|Participants received BIIB054-matching placebo, intravenous (IV) infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388769|NCT03318523|FG001|Participant Flow|PC Period: BIIB054 250 mg (Early Start)|Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388770|NCT03318523|FG002|Participant Flow|PC Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388771|NCT03318523|FG003|Participant Flow|PC Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388772|NCT03318523|FG004|Participant Flow|DBE Period: Placebo to BIIB054 250 mg (Delayed Start)|Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388773|NCT03318523|FG005|Participant Flow|DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)|Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388774|NCT03318523|FG006|Participant Flow|DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)|Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388775|NCT03318523|FG007|Participant Flow|DBE Period: BIIB054 250 mg (Early Start)|Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
11388776|NCT03318523|FG008|Participant Flow|DBE Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
11388777|NCT03318523|FG009|Participant Flow|DBE Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
11388778|NCT03318523|OG000|Outcome|PC Period: Placebo|Participants received BIIB054-matching placebo, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388779|NCT03318523|OG001|Outcome|PC Period: BIIB054 250 mg (Early Start)|Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388780|NCT03318523|OG002|Outcome|PC Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
11388781|NCT03318523|OG003|Outcome|PC Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
11388782|NCT03318523|OG000|Outcome|PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)|Participants who received BIIB054-matching placebo in Year 1 followed by BIIB054 250 mg or 1250 mg or 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) were pooled in this arm.
11388783|NCT03318523|OG001|Outcome|PC Period: Early Start BIIB054 250 mg|Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388784|NCT03318523|OG002|Outcome|PC Period: Early Start BIIB054 1250 mg|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
11388785|NCT03318523|OG003|Outcome|PC Period: Early Start BIIB054 3500 mg|Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in PC Period.
11388786|NCT03318523|OG000|Outcome|BIIB054 250 mg|Participants received BIIB054, 250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
11388787|NCT03318523|OG001|Outcome|BIIB054 1250 mg|Participants received BIIB054, 1250 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
11388788|NCT03318523|OG002|Outcome|BIIB054 3500 mg|Participants received BIIB054, 3500 mg, IV infusion, from Day 1 up to EOS (approximately 3 years).
11388789|NCT03318523|OG002|Outcome|PC Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388790|NCT03318523|EG000|Reported Event|PC Period: Placebo|Participants received BIIB054-matching placebo, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388791|NCT03318523|EG001|Reported Event|PC Period: BIIB054 250 mg (Early Start)|Participants received BIIB054, 250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388792|NCT03318523|EG002|Reported Event|PC Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054, 1250 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388793|NCT03318523|EG003|Reported Event|PC Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054, 3500 mg, IV infusion, on Day 1 and then every 4 weeks for Year 1 in the PC Period.
11388794|NCT03318523|EG004|Reported Event|DBE Period: Placebo to BIIB054 250 mg (Delayed Start)|Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388795|NCT03318523|EG005|Reported Event|DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)|Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388796|NCT03318523|EG006|Reported Event|DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)|Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received placebo in the PC period were included in this arm.
11388797|NCT03318523|EG007|Reported Event|DBE Period: BIIB054 250 mg (Early Start)|Participants received BIIB054 250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 250 mg in the PC period were included in this arm.
11388798|NCT03318523|EG008|Reported Event|DBE Period: BIIB054 1250 mg (Early Start)|Participants received BIIB054 1250 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 1250 mg in the PC period were included in this arm.
11388799|NCT03318523|EG009|Reported Event|DBE Period: BIIB054 3500 mg (Early Start)|Participants received BIIB054 3500 mg, IV infusion from Year 2 up to EOS (approximately 3 years) in the DBE Period. Participants who received BIIB054 3500 mg in the PC period were included in this arm.
11388800|NCT02906020|BG000|Baseline|Part 1: Placebo (ROW)|Participants from rest of world (ROW, except Japan), received placebo (matched to venglustat) capsule orally once daily (QD) for up to 36 weeks in Part 1.
11241443|NCT02486952|FG000|Participant Flow|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11388801|NCT02906020|BG001|Baseline|Part 1: Venglustat 4 mg (ROW)|Participants from ROW (except Japan), received venglustat 4 milligrams (mg) capsule orally QD for up to 36 weeks in Part 1.
11388802|NCT02906020|BG002|Baseline|Part 1: Venglustat 8 mg (ROW)|Participants from ROW (except Japan), received venglustat 8 mg capsule orally QD for up to 36 weeks in Part 1.
11388803|NCT02906020|BG003|Baseline|Part 1: Venglustat 15 mg (ROW)|Participants from ROW (except Japan), received venglustat 15 mg capsule orally QD for up to 36 weeks in Part 1.
11388804|NCT02906020|BG004|Baseline|Part 1: Placebo (Japan Only)|Japanese participants received placebo (matched to venglustat) capsule orally QD for up to 52 weeks in Part 1.
11388805|NCT02906020|BG005|Baseline|Part 1: Venglustat 4 mg (Japan Only)|Japanese participants received venglustat 4 mg capsule orally QD for up to 52 weeks in Part 1.
11388806|NCT02906020|BG006|Baseline|Part 1: Venglustat 8 mg (Japan Only)|Japanese participants received venglustat 8 mg capsule orally QD for up to 52 weeks in Part 1.
11388807|NCT02906020|BG007|Baseline|Part 1: Venglustat 15 mg (Japan Only)|Japanese participants received venglustat 15 mg capsule orally QD for up to 52 weeks in Part 1.
11388808|NCT02906020|BG008|Baseline|Part 2, DB Period: Placebo|Participants received placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388809|NCT02906020|BG009|Baseline|Part 2, DB Period: Venglustat 15 mg|Participants received venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388810|NCT02906020|BG010|Baseline|Total Title|
11388811|NCT02906020|FG000|Participant Flow|Part 1: Placebo (ROW)|Participants from rest of world (ROW, except Japan), received placebo (matched to venglustat) capsule orally once daily (QD) for up to 36 weeks in Part 1.
11388812|NCT02906020|FG001|Participant Flow|Part 1: Venglustat 4 mg (ROW)|Participants from ROW (except Japan), received venglustat 4 milligrams (mg) capsule orally QD for up to 36 weeks in Part 1.
11388813|NCT02906020|FG002|Participant Flow|Part 1: Venglustat 8 mg (ROW)|Participants from ROW (except Japan), received venglustat 8 mg capsule orally QD for up to 36 weeks in Part 1.
11388814|NCT02906020|FG003|Participant Flow|Part 1: Venglustat 15 mg (ROW)|Participants from ROW (except Japan), received venglustat 15 mg capsule orally QD for up to 36 weeks in Part 1.
11388815|NCT02906020|FG004|Participant Flow|Part 1: Placebo (Japan Only)|Japanese participants received placebo (matched to venglustat) capsule orally QD for up to 52 weeks in Part 1.
11388816|NCT02906020|FG005|Participant Flow|Part 1: Venglustat 4 mg (Japan Only)|Japanese participants received venglustat 4 mg capsule orally QD for up to 52 weeks in Part 1.
11388817|NCT02906020|FG006|Participant Flow|Part 1: Venglustat 8 mg (Japan Only)|Japanese participants received venglustat 8 mg capsule orally QD for up to 52 weeks in Part 1.
11388818|NCT02906020|FG007|Participant Flow|Part 1: Venglustat 15 mg (Japan Only)|Japanese participants received venglustat 15 mg capsule orally QD for up to 52 weeks in Part 1.
11388819|NCT02906020|FG008|Participant Flow|Part 2, DB Period: Placebo|Participants received placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388820|NCT02906020|FG009|Participant Flow|Part 2, DB Period: Venglustat 15 mg|Participants received venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388821|NCT02906020|FG010|Participant Flow|Part 2, DB Period: Placebo (Re-randomized From Part 1)|Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388822|NCT02906020|FG011|Participant Flow|Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)|Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388823|NCT02906020|FG012|Participant Flow|Part 2, LTFU Period: Placebo Then Venglustat 15 mg|Participants who were enrolled in the study in Part 2, received placebo (matched to venglustat), completed Part 2 DB period, entered long-term follow-up (LTFU) period to receive venglustat 15 mg capsule orally QD for 156 weeks.
11388824|NCT02906020|FG013|Participant Flow|Part 2, LTFU Period: Venglustat 15 mg|Participants who were enrolled in the study in Part 2, received venglustat 15 mg, completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
11388825|NCT02906020|FG014|Participant Flow|Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)|Participants from Part 1 who were re-randomized in the study in Part 2, received placebo (matched to venglustat) and completed Part 2 DB period, entered LTFU period to receive venglustat (Veng) 15 mg capsule orally QD for 156 weeks.
11388826|NCT02906020|FG015|Participant Flow|Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)|Participants from Part 1 who were re-randomized in the study in Part 2, received venglustat 15 mg and completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
11388827|NCT02906020|OG000|Outcome|Part 1: Placebo (ROW)|Participants from rest of world (ROW, except Japan), received placebo (matched to venglustat) capsule orally once daily (QD) for up to 36 weeks in Part 1.
11388828|NCT02906020|OG001|Outcome|Part 1: Venglustat 4 mg (ROW)|Participants from ROW (except Japan), received venglustat 4 milligrams (mg) capsule orally QD for up to 36 weeks in Part 1.
11388829|NCT02906020|OG002|Outcome|Part 1: Venglustat 8 mg (ROW)|Participants from ROW (except Japan), received venglustat 8 mg capsule orally QD for up to 36 weeks in Part 1.
11388830|NCT02906020|OG003|Outcome|Part 1: Venglustat 15 mg (ROW)|Participants from ROW (except Japan), received venglustat 15 mg capsule orally QD for up to 36 weeks in Part 1.
11388831|NCT02906020|OG004|Outcome|Part 1: Placebo (Japan Only)|Japanese participants received placebo (matched to venglustat) capsule orally QD for up to 52 weeks in Part 1.
11388832|NCT02906020|OG005|Outcome|Part 1: Venglustat 4 mg (Japan Only)|Japanese participants received venglustat 4 mg capsule orally QD for up to 52 weeks in Part 1.
11388833|NCT02906020|OG006|Outcome|Part 1: Venglustat 8 mg (Japan Only)|Japanese participants received venglustat 8 mg capsule orally QD for up to 52 weeks in Part 1.
11388834|NCT02906020|OG007|Outcome|Part 1: Venglustat 15 mg (Japan Only)|Japanese participants received venglustat 15 mg capsule orally QD for up to 52 weeks in Part 1.
11388835|NCT02906020|OG000|Outcome|Part 2, DB Period: Placebo|Participants received placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388836|NCT02906020|OG001|Outcome|Part 2, DB Period: Venglustat 15 mg|Participants received venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388837|NCT02906020|EG000|Reported Event|Part 1: Placebo (ROW)|Participants from rest of world (ROW, except Japan), received placebo (matched to venglustat) capsule orally once daily (QD) for up to 36 weeks in Part 1.
11388838|NCT02906020|EG001|Reported Event|Part 1: Venglustat 4 mg (ROW)|Participants from ROW (except Japan), received venglustat 4 milligrams (mg) capsule orally QD for up to 36 weeks in Part 1.
11388839|NCT02906020|EG002|Reported Event|Part 1: Venglustat 8 mg (ROW)|Participants from ROW (except Japan), received venglustat 8 mg capsule orally QD for up to 36 weeks in Part 1.
11388840|NCT02906020|EG003|Reported Event|Part 1: Venglustat 15 mg (ROW)|Participants from ROW (except Japan), received venglustat 15 mg capsule orally QD for up to 36 weeks in Part 1.
11388841|NCT02906020|EG004|Reported Event|Part 1: Placebo (Japan Only)|Japanese participants received placebo (matched to venglustat) capsule orally QD for up to 52 weeks in Part 1.
11388842|NCT02906020|EG005|Reported Event|Part 1: Venglustat 4 mg (Japan Only)|Japanese participants received venglustat 4 mg capsule orally QD for up to 52 weeks in Part 1.
11388843|NCT02906020|EG006|Reported Event|Part 1: Venglustat 8 mg (Japan Only)|Japanese participants received venglustat 8 mg capsule orally QD for up to 52 weeks in Part 1.
11388844|NCT02906020|EG007|Reported Event|Part 1: Venglustat 15 mg (Japan Only)|Japanese participants received venglustat 15 mg capsule orally QD for up to 52 weeks in Part 1.
11388845|NCT02906020|EG008|Reported Event|Part 2, DB Period: Placebo|Participants received placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388846|NCT02906020|EG009|Reported Event|Part 2, DB Period: Venglustat 15 mg|Participants received venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388847|NCT02906020|EG010|Reported Event|Part 2, DB Period: Placebo (Re-randomized From Part 1)|Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
11388848|NCT02906020|EG011|Reported Event|Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)|Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
11388849|NCT02906020|EG012|Reported Event|Part 2, LTFU Period: Placebo Then Venglustat 15 mg|Participants who were enrolled in the study in Part 2, received placebo (matched to venglustat), completed Part 2 DB period, entered long-term follow-up (LTFU) period to receive venglustat 15 mg capsule orally QD for 156 weeks.
11388850|NCT02906020|EG013|Reported Event|Part 2, LTFU Period: Venglustat 15 mg|Participants who were enrolled in the study in Part 2, received venglustat 15 mg, completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
11388851|NCT02906020|EG014|Reported Event|Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)|Participants from Part 1 who were re-randomized in the study in Part 2, received placebo (matched to venglustat) and completed Part 2 DB period, entered LTFU period to receive venglustat (Veng) 15 mg capsule orally QD for 156 weeks.
11388852|NCT02906020|EG015|Reported Event|Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)|Participants from Part 1 who were re-randomized in the study in Part 2, received venglustat 15 mg and completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
10803932|NCT01049035|OG003|Outcome|Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months|Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
11388853|NCT02891226|BG000|Baseline|Placebo IV Q4W|Participants received placebo administered IV Q4W.
11388854|NCT02891226|BG001|Baseline|200 mg Mirikizumab IV Q4W|Participants received 200 mg mirikizumab administered IV Q4W.
11388855|NCT02891226|BG002|Baseline|600 mg Mirikizumab IV Q4W|Participants received 600 mg mirikizumab administered IV Q4W.
11388856|NCT02891226|BG003|Baseline|1000 mg Mirikizumab IV Q4W|Participants received 1000 mg mirikizumab administered IV Q4W.
11388857|NCT02891226|BG004|Baseline|Total|Total of all reporting groups
11388858|NCT02891226|FG000|Participant Flow|Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)|Participants received placebo administered intravenously (IV) Q4W.
11388859|NCT02891226|FG001|Participant Flow|Period 1: 200 Milligram (mg) Mirikizumab IV Q4W|Participants received 200 mg mirikizumab administered IV Q4W.
11388860|NCT02891226|FG002|Participant Flow|Period 1: 600 mg Mirikizumab IV Q4W|Participants received 600 mg mirikizumab administered IV Q4W.
11388861|NCT02891226|FG003|Participant Flow|Period 1: 1000 mg Mirikizumab IV Q4W|Participants received 1000 mg mirikizumab administered IV Q4W.
11388862|NCT02891226|FG004|Participant Flow|Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388863|NCT02891226|FG005|Participant Flow|Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388864|NCT02891226|FG006|Participant Flow|Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388865|NCT02891226|FG007|Participant Flow|Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)|Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
11388866|NCT02891226|FG008|Participant Flow|Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)|Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
11388867|NCT02891226|FG009|Participant Flow|Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)|Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
10965828|NCT00884221|OG000|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
10965829|NCT00884221|OG001|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
10965830|NCT00884221|OG000|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
11388868|NCT02891226|FG010|Participant Flow|Period 3: 300 mg Mirikizumab SC Q4W|Participants received 300 mg mirikizumab administered SC Q4W.
11388869|NCT02891226|FG011|Participant Flow|Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2|Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
11388870|NCT02891226|FG012|Participant Flow|Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)|Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
11388871|NCT02891226|FG013|Participant Flow|Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)|Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
11388872|NCT02891226|FG014|Participant Flow|Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)|Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
11388873|NCT02891226|FG015|Participant Flow|Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3|Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
11388874|NCT02891226|OG000|Outcome|Placebo IV Q4W|Participants received placebo administered IV Q4W.
11388875|NCT02891226|OG001|Outcome|200 mg Mirikizumab IV Q4W|Participants received 200 mg mirikizumab administered IV Q4W.
11388876|NCT02891226|OG002|Outcome|600 mg Mirikizumab IV Q4W|Participants received 600 mg mirikizumab administered IV Q4W.
11388877|NCT02891226|OG003|Outcome|1000 mg Mirikizumab IV Q4W|Participants received 1000 mg mirikizumab administered IV Q4W.
11388878|NCT02891226|OG000|Outcome|Placebo IV Q4W|Participants received placebo administered IV Q4W
11388879|NCT02891226|OG000|Outcome|Mirikizumab IV Q4W|Participants received 200 mg, 600 mg, 1000 mg mirikizumab administered IV Q4W.
11388880|NCT02891226|EG000|Reported Event|Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)|Participants received placebo administered intravenously (IV) Q4W.
11388881|NCT02891226|EG001|Reported Event|Period 1: 200 Milligram (mg) Mirikizumab IV Q4W|Participants received 200 mg mirikizumab administered IV Q4W.
11388882|NCT02891226|EG002|Reported Event|Period 1: 600 mg Mirikizumab IV Q4W|Participants received 600 mg mirikizumab administered IV Q4W.
11388883|NCT02891226|EG003|Reported Event|Period 1: 1000 mg Mirikizumab IV Q4W|Participants received 1000 mg mirikizumab administered IV Q4W.
11388884|NCT02891226|EG004|Reported Event|Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388885|NCT02891226|EG005|Reported Event|Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388886|NCT02891226|EG006|Reported Event|Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)|Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
11388887|NCT02891226|EG007|Reported Event|Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)|Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
11388888|NCT02891226|EG008|Reported Event|Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)|Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
11388889|NCT02891226|EG009|Reported Event|Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)|Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
11388890|NCT02891226|EG010|Reported Event|Period 3: 300 mg Mirikizumab SC Q4W|Participants received 300 mg mirikizumab administered SC Q4W.
11388891|NCT02891226|EG011|Reported Event|Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2|Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
11388892|NCT02891226|EG012|Reported Event|Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)|Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
11388893|NCT02891226|EG013|Reported Event|Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)|Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
11388894|NCT02891226|EG014|Reported Event|Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)|Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
11388895|NCT02891226|EG015|Reported Event|Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3|Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
11388896|NCT02703480|BG000|Baseline|All Study Participants|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane~Ti-mesh: Titanium mesh"
11388897|NCT02703480|FG000|Participant Flow|All Study Participants - d-PTFE|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.~d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane"
11388898|NCT02703480|FG001|Participant Flow|All Study Participants - Ti-mesh|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane~Ti-mesh: Titanium mesh"
11388899|NCT02703480|OG000|Outcome|All Study Participants - d-PTFE|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.~d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane"
11388900|NCT02703480|OG001|Outcome|All Study Participants - Ti-mesh|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane~Ti-mesh: Titanium mesh"
11388901|NCT02703480|EG000|Reported Event|All Study Participants - d-PTFE|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.~d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane"
11388902|NCT02703480|EG001|Reported Event|All Study Participants - Ti-mesh|"The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane~Ti-mesh: Titanium mesh"
11388903|NCT02549092|BG000|Baseline|Optimized Medical Treatment|"Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.~Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG."
11388904|NCT02549092|BG001|Baseline|LCIG|"Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.~The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.~Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG."
11388905|NCT02549092|BG002|Baseline|Total|Total of all reporting groups
11388906|NCT02549092|FG000|Participant Flow|Optimized Medical Treatment|"Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.~Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG."
11388907|NCT02549092|FG001|Participant Flow|LCIG|"Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.~The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.~Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG."
11388908|NCT02549092|OG000|Outcome|Optimized Medical Treatment|Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.
11388909|NCT02549092|OG001|Outcome|LCIG|"Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.~The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day."
11388910|NCT02549092|OG001|Outcome|LCIG|"Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.~The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day"
11388911|NCT02549092|EG000|Reported Event|Optimized Medical Treatment (OMT)|Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.
11388912|NCT02549092|EG001|Reported Event|LCIG|"Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated.~The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day."
11388913|NCT02549092|EG002|Reported Event|Extension/Transition OMT->LCIG|Participants randomized to continue OMT in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.
11388914|NCT02549092|EG003|Reported Event|Extension/Transition LCIG->LCIG|Participants randomized to LCIG in the United States or South Korea who elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.
11388915|NCT02506465|BG000|Baseline|iTind Arm|"iTind implant is implant during the study for 5-7 days.~iTIND: Temporary Implantable Nitinol Device (iTIND)"
11388916|NCT02506465|BG001|Baseline|Sham Arm|"Foley catheter is used during the study~Sham Arm: Foley catheter will be placed and immediately removed."
11388917|NCT02506465|BG002|Baseline|Total|Total of all reporting groups
11388918|NCT02506465|FG000|Participant Flow|iTind Arm|"iTind implant is implant during the study for 5-7 days.~iTIND: Temporary Implantable Nitinol Device (iTIND)"
11388919|NCT02506465|FG001|Participant Flow|Sham Arm|"Foley catheter is used during the study~Sham Arm: Foley catheter will be placed and immediately removed."
11388920|NCT02506465|OG000|Outcome|iTind Arm|"iTind implant is implant during the study for 5-7 days.~iTIND: Temporary Implantable Nitinol Device (iTIND)"
11388921|NCT02506465|OG001|Outcome|Sham Arm|"Foley catheter is used during the study~Sham Arm: Foley catheter will be placed and immediately removed."
11388922|NCT02506465|EG000|Reported Event|iTind Arm|iTind implant is implant during the study for 5-7 days. Temporary Implantable Nitinol Device (iTIND).
11388923|NCT02506465|EG001|Reported Event|Sham Arm|Foley catheter is used during the study. Foley catheter will be placed and immediately removed.
11388924|NCT02323126|BG000|Baseline|Nivolumab and EGF816|Group 1: EGF816 150 mg QD + Nivolumab 3 mg/kg Q2W
11388925|NCT02323126|BG001|Baseline|Nivolumab and INC280, High cMet|Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
11388926|NCT02323126|BG002|Baseline|Nivolumab and INC280, Low cMet|Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W
11388927|NCT02323126|BG003|Baseline|Total|Total of all reporting groups
11388928|NCT02323126|FG000|Participant Flow|Nivolumab and EGF816|Group 1: EGF816 150 mg QD + Nivolumab 3 mg/kg Q2W
11388929|NCT02323126|FG001|Participant Flow|Nivolumab and INC280, High cMet|Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
11388930|NCT02323126|FG002|Participant Flow|Nivolumab and INC280, Low cMet|Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W
11388931|NCT02323126|OG000|Outcome|Nivolumab and EGF816|Group 1: EGF816 150 mg QD + Nivolumab 3 mg/kg Q2W
11388932|NCT02323126|OG001|Outcome|Nivolumab and INC280, High cMet|Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
11388933|NCT02323126|OG002|Outcome|Nivolumab and INC280, Low cMet|Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W
11388934|NCT02323126|OG000|Outcome|Nivolumab and INC280, High cMet|Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
11388935|NCT02323126|OG001|Outcome|Nivolumab and INC280, Low cMet|Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W
11388936|NCT02323126|EG000|Reported Event|Nivolumab and EGF816|Group 1: EGF816 150 mg QD + Nivolumab 3 mg/kg Q2W
11388937|NCT02323126|EG001|Reported Event|Nivolumab and INC280, High cMet|Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
11388938|NCT02323126|EG002|Reported Event|Nivolumab and INC280, Low cMet|Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W
11388939|NCT02323126|EG003|Reported Event|Nivolumab and INC280, High+Low cMet|Group 2A+2B (low and high cMet): INC280 400 mg BID + Nivolumab 3 mg/kg Q2W
11388940|NCT01902290|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388941|NCT01902290|BG001|Baseline|Brodalumab 210 mg|Participants received brodalumab 210 mg administered by subcutaneous injection on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388942|NCT01902290|BG002|Baseline|Total|Total of all reporting groups
10965831|NCT00884221|OG001|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
10965832|NCT00884221|EG000|Reported Event|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
10965833|NCT00884221|EG001|Reported Event|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
10965834|NCT00884273|BG000|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10965835|NCT00884273|BG001|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
10965836|NCT00884273|BG002|Baseline|Total|Total of all reporting groups
11388943|NCT01902290|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injections on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
10965837|NCT00884273|FG000|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10965838|NCT00884273|FG001|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
11241444|NCT02486952|OG000|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11388944|NCT01902290|FG001|Participant Flow|Brodalumab 210 mg|Participants received brodalumab 210 mg administered by subcutaneous injection on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
10965839|NCT00884273|OG000|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
11388945|NCT01902290|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388946|NCT01902290|OG001|Outcome|Brodalumab 210 mg|Participants received brodalumab 210 mg administered by subcutaneous injection on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388947|NCT01902290|OG000|Outcome|Brodalumab 210 mg|Participants received brodalumab 210 mg administered by subcutaneous injection on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388948|NCT01902290|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388949|NCT01902290|EG001|Reported Event|Brodalumab 210 mg|Participants received brodalumab 210 mg administered by subcutaneous injection on day 1 and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22.
11388950|NCT01126749|BG000|Baseline|Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 0.7 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388951|NCT01126749|BG001|Baseline|Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388952|NCT01126749|BG002|Baseline|Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388953|NCT01126749|BG003|Baseline|Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388954|NCT01126749|BG004|Baseline|Total|Total of all reporting groups
11388955|NCT01126749|FG000|Participant Flow|Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 0.7 milligram per square meter (mg/m^2), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of disease progression (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388956|NCT01126749|FG001|Participant Flow|Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388957|NCT01126749|FG002|Participant Flow|Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388958|NCT01126749|FG003|Participant Flow|Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388959|NCT01126749|OG000|Outcome|Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 0.7 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388960|NCT01126749|OG001|Outcome|Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
10803933|NCT01049035|OG004|Outcome|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11388961|NCT01126749|OG000|Outcome|Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388962|NCT01126749|OG001|Outcome|Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388963|NCT01126749|EG000|Reported Event|Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 0.7 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388964|NCT01126749|EG001|Reported Event|Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388965|NCT01126749|EG002|Reported Event|Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Eribulin Mesylate 1.0 mg/m^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388966|NCT01126749|EG003|Reported Event|Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2|Participants received Gemcitabine 1000 mg/m^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
11388967|NCT01111110|BG000|Baseline|Anti-static/Static|albuterol with anti-static chamber then Static on another night
11388968|NCT01111110|BG001|Baseline|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
11388969|NCT01111110|BG002|Baseline|Total|Total of all reporting groups
11388970|NCT01111110|FG000|Participant Flow|Anti-static/Static|albuterol with anti-static chamber then Static on another night
11388971|NCT01111110|FG001|Participant Flow|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
11388972|NCT01111110|OG000|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
11388973|NCT01111110|OG001|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
11388974|NCT01111110|EG000|Reported Event|Static|albuterol with static chamber
11388975|NCT01111110|EG001|Reported Event|Antistatic|albuterol with antistatic chamber.
11388976|NCT01059448|BG000|Baseline|Placebo Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388977|NCT01059448|BG001|Baseline|70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388978|NCT01059448|BG002|Baseline|140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK|"Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388979|NCT01059448|BG003|Baseline|210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388980|NCT01059448|BG004|Baseline|Total|Total of all reporting groups
11388981|NCT01059448|FG000|Participant Flow|Placebo Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388982|NCT01059448|FG001|Participant Flow|70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388983|NCT01059448|FG002|Participant Flow|140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK|"Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388984|NCT01059448|FG003|Participant Flow|210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388985|NCT01059448|OG000|Outcome|Placebo Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388986|NCT01059448|OG001|Outcome|70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388987|NCT01059448|OG002|Outcome|140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK|"Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388988|NCT01059448|OG003|Outcome|210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388989|NCT01059448|EG000|Reported Event|Placebo / AMG 827 210 mg Q2WK|"Participants who were administered matching placebo in parent study 2009061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).~Participants also received weekly intramuscular, oral or SC doses of methotrexate."
11388990|NCT01059448|EG001|Reported Event|70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388991|NCT01059448|EG002|Reported Event|140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK|"Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388992|NCT01059448|EG003|Reported Event|210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK|"Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.~Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate."
11388993|NCT00821587|BG000|Baseline|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08- 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter.
11388994|NCT00821587|BG001|Baseline|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
11388995|NCT00821587|BG002|Baseline|Total|Total of all reporting groups
11388996|NCT00821587|FG000|Participant Flow|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08- 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter.
11388997|NCT00821587|FG001|Participant Flow|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
11388998|NCT00821587|OG000|Outcome|Tacrolimus (TAC)|Tacrolimus 0.08-0.12 mg/kg/day orally in two divided doses
11388999|NCT00821587|OG001|Outcome|Cyclosporine (CsA)|Cyclosporine 2.0-4.0 mg/kg/day orally in two divided doses
11389000|NCT00821587|EG000|Reported Event|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08- 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter.
11389001|NCT00821587|EG001|Reported Event|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
11389002|NCT00585195|BG000|Baseline|Low Dose Escalation Cohort: Crizotinib 50 mg QD|Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
11389003|NCT00585195|BG001|Baseline|Low Dose Escalation Cohort: Crizotinib 100 mg QD|Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389004|NCT00585195|BG002|Baseline|Low Dose Escalation Cohort: Crizotinib 200 mg QD|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
11389005|NCT00585195|BG003|Baseline|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389006|NCT00585195|BG004|Baseline|Low Dose Escalation Cohort: Crizotinib 250 mg BID|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
11389007|NCT00585195|BG005|Baseline|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389008|NCT00585195|BG006|Baseline|High Dose Escalation Cohort: Crizotinib 300 mg QD|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389009|NCT00585195|BG007|Baseline|High Dose Escalation Cohort: Crizotinib 400 mg QD|Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389010|NCT00585195|BG008|Baseline|High Dose Escalation Cohort: Crizotinib 500 mg QD|Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389011|NCT00585195|BG009|Baseline|High Dose Escalation Cohort: Crizotinib 650 mg QD|Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
11389012|NCT00585195|BG010|Baseline|High Dose Escalation Cohort: Crizotinib 800 mg QD|Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389013|NCT00585195|BG011|Baseline|RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
11389014|NCT00585195|BG012|Baseline|RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
11389015|NCT00585195|BG013|Baseline|RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
11389016|NCT00585195|BG014|Baseline|RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).
11389017|NCT00585195|BG015|Baseline|RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
11389018|NCT00585195|BG016|Baseline|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389019|NCT00585195|BG017|Baseline|RP2D Cohort: Enriched Other: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
11389020|NCT00585195|BG018|Baseline|RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole|Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.
11389021|NCT00585195|BG019|Baseline|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.
11389022|NCT00585195|BG020|Baseline|RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID with or without food from Day 1 Cycle 1 up to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1
11389023|NCT00585195|BG021|Baseline|Total|Total of all reporting groups
11389024|NCT00585195|FG000|Participant Flow|Low Dose Escalation Cohort: Crizotinib 50 mg QD|Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
11389025|NCT00585195|FG001|Participant Flow|Low Dose Escalation Cohort: Crizotinib 100 mg QD|Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389026|NCT00585195|FG002|Participant Flow|Low Dose Escalation Cohort: Crizotinib 200 mg QD|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
10803934|NCT01049035|OG005|Outcome|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
10965840|NCT00884273|OG001|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
11389027|NCT00585195|FG003|Participant Flow|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389028|NCT00585195|FG004|Participant Flow|Low Dose Escalation Cohort: Crizotinib 250 mg BID|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
11389029|NCT00585195|FG005|Participant Flow|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389030|NCT00585195|FG006|Participant Flow|High Dose Escalation Cohort: Crizotinib 300 mg QD|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389031|NCT00585195|FG007|Participant Flow|High Dose Escalation Cohort: Crizotinib 400 mg QD|Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389032|NCT00585195|FG008|Participant Flow|High Dose Escalation Cohort: Crizotinib 500 mg QD|Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11197433|NCT02171065|FG000|Participant Flow|Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to guideline-directed medical therapy (GDMT) group. Patients remain in PROSPECT II cohort.
11197434|NCT02171065|FG001|Participant Flow|ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.
11389033|NCT00585195|FG009|Participant Flow|High Dose Escalation Cohort: Crizotinib 650 mg QD|Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
11389034|NCT00585195|FG010|Participant Flow|High Dose Escalation Cohort: Crizotinib 800 mg QD|Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389035|NCT00585195|FG011|Participant Flow|RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
11389036|NCT00585195|FG012|Participant Flow|RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
11389037|NCT00585195|FG013|Participant Flow|RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
11389038|NCT00585195|FG014|Participant Flow|RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).
11389039|NCT00585195|FG015|Participant Flow|RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
11389040|NCT00585195|FG016|Participant Flow|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389041|NCT00585195|FG017|Participant Flow|RP2D Cohort: Enriched Other: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
11389042|NCT00585195|FG018|Participant Flow|RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole|Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.
11389043|NCT00585195|FG019|Participant Flow|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.
11389044|NCT00585195|FG020|Participant Flow|RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID with or without food from Day 1 Cycle 1 up to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1
11389045|NCT00585195|OG000|Outcome|Low Dose Escalation Cohort: Crizotinib 50 mg QD|Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
11389046|NCT00585195|OG001|Outcome|Low Dose Escalation Cohort: Crizotinib 100 mg QD|Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389047|NCT00585195|OG002|Outcome|Low Dose Escalation Cohort: Crizotinib 200 mg QD|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
10965841|NCT00884273|EG000|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
10965842|NCT00884273|EG001|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
10965843|NCT00884286|BG000|Baseline|Aplidin® (Cohort Non-cutaneous)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389048|NCT00585195|OG003|Outcome|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389049|NCT00585195|OG004|Outcome|Low Dose Escalation Cohort: Crizotinib 250 mg BID|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
11389050|NCT00585195|OG005|Outcome|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389051|NCT00585195|OG006|Outcome|High Dose Escalation Cohort: Crizotinib 300 mg QD|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389052|NCT00585195|OG007|Outcome|High Dose Escalation Cohort: Crizotinib 400 mg QD|Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389053|NCT00585195|OG008|Outcome|High Dose Escalation Cohort: Crizotinib 500 mg QD|Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389054|NCT00585195|OG009|Outcome|High Dose Escalation Cohort: Crizotinib 650 mg QD|Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
11389055|NCT00585195|OG010|Outcome|High Dose Escalation Cohort: Crizotinib 800 mg QD|Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389056|NCT00585195|OG001|Outcome|Low Dose Escalation Cohort: Crizotinib 200 mg QD|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
11389057|NCT00585195|OG002|Outcome|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389058|NCT00585195|OG003|Outcome|Low Dose Escalation Cohort: Crizotinib 250 mg BID|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
11389059|NCT00585195|OG004|Outcome|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389060|NCT00585195|OG005|Outcome|High Dose Escalation Cohort: Crizotinib 300 mg QD|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389061|NCT00585195|OG006|Outcome|High Dose Escalation Cohort: Crizotinib 400 mg QD|Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389062|NCT00585195|OG007|Outcome|High Dose Escalation Cohort: Crizotinib 500 mg QD|Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389063|NCT00585195|OG008|Outcome|High Dose Escalation Cohort: Crizotinib 650 mg QD|Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
11389064|NCT00585195|OG009|Outcome|High Dose Escalation Cohort: Crizotinib 800 mg QD|Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389065|NCT00585195|OG010|Outcome|RP2D Cohort: Crizotinib 250 mg|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
11389066|NCT00585195|OG000|Outcome|Low Dose Escalation Cohort: Crizotinib 100 mg QD|Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389067|NCT00585195|OG001|Outcome|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389068|NCT00585195|OG002|Outcome|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389069|NCT00585195|OG003|Outcome|RP2D Cohort: Crizotinib 250 mg|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
11389070|NCT00585195|OG011|Outcome|RP2D Cohort: Crizotinib 250 mg|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
11389071|NCT00585195|OG006|Outcome|RP2D Cohort: Crizotinib 250 mg|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
11389072|NCT00585195|OG011|Outcome|RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days)
11389073|NCT00585195|OG012|Outcome|RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
11389074|NCT00585195|OG013|Outcome|RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
11389075|NCT00585195|OG014|Outcome|RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).
11389076|NCT00585195|OG015|Outcome|RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
10803935|NCT01049035|OG000|Outcome|Group 5: MenACYW Conjugate Vaccine: 12 Months|Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
11389077|NCT00585195|OG016|Outcome|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389078|NCT00585195|OG017|Outcome|RP2D Cohort: Enriched Other: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
11389079|NCT00585195|OG018|Outcome|RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole|Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.
11389080|NCT00585195|OG019|Outcome|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.
11389081|NCT00585195|OG020|Outcome|RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID with or without food from Day 1 Cycle 1 up to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1
11389082|NCT00585195|OG000|Outcome|Low Dose Escalation Cohort: Crizotinib 100 mg QD (Midazolam Alone)|Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389083|NCT00585195|OG001|Outcome|Low Dose Escalation Cohort: Crizotinib 100 mg QD + Midazolam|Participants received Crizotinib 100 mg capsule or tablet orally QD along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.
11389084|NCT00585195|OG002|Outcome|Low Dose Escalation Cohort: Crizotinib 300 mg BID (Midazolam Alone)|Participants who did not receive Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet BID on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389085|NCT00585195|OG003|Outcome|Low Dose Escalation Cohort: Crizotinib 300 mg BID + Midazolam|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID along with 2 mg oral dose of Midazolam on Cycle 2 Day 1.
11389086|NCT00585195|OG004|Outcome|RP2D Cohort: Crizotinib 250 mg (Midazolam Alone)|Participants who did not receive Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389087|NCT00585195|OG005|Outcome|RP2D Cohort: Crizotinib 250 mg + Midazolam|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) BID along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.
11389088|NCT00585195|OG004|Outcome|RP2D Cohort: Crizotinib 250 mg (Midazolam Alone)|Participants who did not receive Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet on Day -7, received single 2 mg oral dose of Midazolam on Day -7
11389089|NCT00585195|OG005|Outcome|RP2D Cohort: Crizotinib 250 mg +Midazolam|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) BID along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.
11389090|NCT00585195|OG000|Outcome|RP2D Cohort: Crizotinib 250 mg With Food|Participants who were enrolled in enriched RP2D cohort received single dose of Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally with food on Day -7.
10965844|NCT00884286|BG001|Baseline|Aplidin® (Cohort Other Lymphoma)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389091|NCT00585195|OG000|Outcome|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days).
11389092|NCT00585195|OG001|Outcome|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after a meal.
11389093|NCT00585195|OG000|Outcome|RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone|Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days).
11389094|NCT00585195|OG001|Outcome|Itraconazole Interaction Cohort: Crizotinib 250 mg + Itraconazole|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16. (each cycle 28 days).
11389095|NCT00585195|OG001|Outcome|RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16. (each cycle 28 days).
11389096|NCT00585195|OG000|Outcome|RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
11389097|NCT00585195|OG001|Outcome|RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
11389098|NCT00585195|OG002|Outcome|RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
11389099|NCT00585195|OG003|Outcome|RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
11389100|NCT00585195|OG004|Outcome|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389101|NCT00585195|OG005|Outcome|RP2D Cohort: Enriched Other: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
11389102|NCT00585195|OG003|Outcome|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389103|NCT00585195|OG002|Outcome|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389104|NCT00585195|OG000|Outcome|RP2D Cohort: Crizotinib 250 mg|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
11389105|NCT00585195|EG000|Reported Event|Low Dose Escalation Cohort: Crizotinib 50 mg QD|Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
11389106|NCT00585195|EG001|Reported Event|Low Dose Escalation Cohort: Crizotinib 100 mg QD|Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389107|NCT00585195|EG002|Reported Event|Low Dose Escalation Cohort: Crizotinib 200 mg QD|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
11389108|NCT00585195|EG003|Reported Event|Low Dose Escalation Cohort: Crizotinib 200 mg BID|Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
11389109|NCT00585195|EG004|Reported Event|Low Dose Escalation Cohort: Crizotinib 250 mg BID|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
11389110|NCT00585195|EG005|Reported Event|Low Dose Escalation Cohort: Crizotinib 300 mg BID|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
11389111|NCT00585195|EG006|Reported Event|High Dose Escalation Cohort: Crizotinib 300 mg QD|Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389112|NCT00585195|EG007|Reported Event|High Dose Escalation Cohort: Crizotinib 400 mg QD|Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389113|NCT00585195|EG008|Reported Event|High Dose Escalation Cohort: Crizotinib 500 mg QD|Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389114|NCT00585195|EG009|Reported Event|High Dose Escalation Cohort: Crizotinib 650 mg QD|Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
11389115|NCT00585195|EG010|Reported Event|High Dose Escalation Cohort: Crizotinib 800 mg QD|Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
11389116|NCT00585195|EG011|Reported Event|RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
11389117|NCT00585195|EG012|Reported Event|RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
11389118|NCT00585195|EG013|Reported Event|RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
11389119|NCT00585195|EG014|Reported Event|RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).
10965845|NCT00884286|BG002|Baseline|Total|Total of all reporting groups
11197435|NCT02171065|FG002|Participant Flow|PROSPECT II Only|Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
11389120|NCT00585195|EG015|Reported Event|RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
11389121|NCT00585195|EG016|Reported Event|RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
11389122|NCT00585195|EG017|Reported Event|RP2D Cohort: Enriched Other: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
11389123|NCT00585195|EG018|Reported Event|Itraconazole Interaction Sub-study: Crizotinib 250 mg|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.
11389124|NCT00585195|EG019|Reported Event|RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin|Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.
11389125|NCT00585195|EG020|Reported Event|Midazolam Interaction Cohort: Crizotinib 250|Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID from Day 1Cycle 1 up to p to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1.
11389126|NCT04446429|BG000|Baseline|Usual Care|"Usual care as determined by the PI~Usual Care: Care as determined by the PI"
11389127|NCT04446429|BG001|Baseline|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by the PI~Proxalutamide: 200 mg q.d."
11389128|NCT04446429|BG002|Baseline|Total|Total of all reporting groups
11389129|NCT04446429|FG000|Participant Flow|Usual Care|"Usual care as determined by the PI~Usualf Care: Care as determined by the PI"
11389130|NCT04446429|FG001|Participant Flow|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by the PI~Proxalutamide: 200 mg q.d."
11389131|NCT04446429|OG000|Outcome|Usual Care|"Usual care as determined by the PI~Usual Care: Care as determined by the PI"
11389132|NCT04446429|OG001|Outcome|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by the PI~Proxalutamide: 200 mg q.d."
11389133|NCT04446429|EG000|Reported Event|Usual Care|"Usual care as determined by the PI~Usual Care: Care as determined by the PI"
11389134|NCT04446429|EG001|Reported Event|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by the PI~Proxalutamide: 200 mg q.d."
11389135|NCT04372017|BG000|Baseline|Cohort A: Healthcare Worker (Hydroxychloroquine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389136|NCT04372017|BG001|Baseline|Cohort A: Healthcare Worker (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389137|NCT04372017|BG002|Baseline|Cohort B: High-Risk Participant (Hydroxychloroqine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389138|NCT04372017|BG003|Baseline|Cohort B: High-Risk Participant (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389139|NCT04372017|BG004|Baseline|Total|Total of all reporting groups
11389140|NCT04372017|FG000|Participant Flow|Cohort A: Healthcare Worker (Hydroxychloroquine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389141|NCT04372017|FG001|Participant Flow|Cohort A: Healthcare Worker (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389142|NCT04372017|FG002|Participant Flow|Cohort B: High-Risk Participant (Hydroxychloroqine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389143|NCT04372017|FG003|Participant Flow|Cohort B: High-Risk Participant (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389144|NCT04372017|OG000|Outcome|Cohort A: Healthcare Worker (Hydroxychloroquine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389145|NCT04372017|OG001|Outcome|Cohort A: Healthcare Worker (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389146|NCT04372017|OG002|Outcome|Cohort B: High-Risk Participant (Hydroxychloroqine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389147|NCT04372017|OG003|Outcome|Cohort B: High-Risk Participant (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389148|NCT04372017|EG000|Reported Event|Cohort A: Healthcare Worker (Hydroxychloroquine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389149|NCT04372017|EG001|Reported Event|Cohort A: Healthcare Worker (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389150|NCT04372017|EG002|Reported Event|Cohort B: High-Risk Participant (Hydroxychloroqine)|Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
11389151|NCT04372017|EG003|Reported Event|Cohort B: High-Risk Participant (Placebo)|Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
11389152|NCT04194528|BG000|Baseline|Oxycodone/Acetaminophen (5/325 mg) DMP|"The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Oxycodone/acetaminophen 5/325 mg: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Proteus digital medicine program: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks."
11389153|NCT04194528|FG000|Participant Flow|Oxycodone/Acetaminophen (5/325 mg) DMP|"The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Oxycodone/acetaminophen 5/325 mg: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Proteus digital medicine program: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks."
11389154|NCT04194528|OG000|Outcome|Oxycodone/Acetaminophen (5/325 mg) DMP|"The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Oxycodone/acetaminophen 5/325 mg: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Proteus digital medicine program: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks."
11389155|NCT04194528|EG000|Reported Event|Oxycodone/Acetaminophen (5/325 mg) DMP|"The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Oxycodone/acetaminophen 5/325 mg: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.~Proteus digital medicine program: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks."
11389156|NCT04147650|BG000|Baseline|0.05% Voclosporin Ophthalmic Solution (VOS)|"0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389157|NCT04147650|BG001|Baseline|0.10% VOS|"0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389158|NCT04147650|BG002|Baseline|0.20% VOS|"0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389159|NCT04147650|BG003|Baseline|Vehicle Ophthalmic Solution|"Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks~Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks"
11389160|NCT04147650|BG004|Baseline|Total|Total of all reporting groups
11389161|NCT04147650|FG000|Participant Flow|0.05% Voclosporin Ophthalmic Solution (VOS)|"0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389162|NCT04147650|FG001|Participant Flow|0.10% VOS|"0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389163|NCT04147650|FG002|Participant Flow|0.20% VOS|"0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389164|NCT04147650|FG003|Participant Flow|Vehicle Ophthalmic Solution|"Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks~Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks"
11389165|NCT04147650|OG000|Outcome|0.05% Voclosporin Ophthalmic Solution (VOS)|"0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389166|NCT04147650|OG001|Outcome|0.10% VOS|"0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389167|NCT04147650|OG002|Outcome|0.20% VOS|"0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389168|NCT04147650|OG003|Outcome|Vehicle Ophthalmic Solution|"Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks~Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks"
11389169|NCT04147650|EG000|Reported Event|0.05% Voclosporin Ophthalmic Solution (VOS)|"0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389170|NCT04147650|EG001|Reported Event|0.10% VOS|"0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389171|NCT04147650|EG002|Reported Event|0.20% VOS|"0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks~0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks"
11389172|NCT04147650|EG003|Reported Event|Vehicle Ophthalmic Solution|"Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks~Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks"
11389173|NCT03527238|BG000|Baseline|Standard of Care|"Standard of Care Tacrolimus Drug Dosing~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389174|NCT03527238|BG001|Baseline|Phenotypic Precision Medicine (PPM)|"PPM-based Computation Assisted Drug Dosing~PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM.~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389175|NCT03527238|BG002|Baseline|Total|Total of all reporting groups
11389176|NCT03527238|FG000|Participant Flow|Standard of Care|"Standard of Care Tacrolimus Drug Dosing~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389177|NCT03527238|FG001|Participant Flow|Phenotypic Precision Medicine (PPM)|"PPM-based Computation Assisted Drug Dosing~PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM.~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389178|NCT03527238|OG000|Outcome|Standard of Care|"Standard of Care Tacrolimus Drug Dosing~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389179|NCT03527238|OG001|Outcome|Phenotypic Precision Medicine (PPM)|"PPM-based Computation Assisted Drug Dosing~PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM.~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389180|NCT03527238|EG000|Reported Event|Standard of Care|"Standard of Care Tacrolimus Drug Dosing~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389181|NCT03527238|EG001|Reported Event|Phenotypic Precision Medicine (PPM)|"PPM-based Computation Assisted Drug Dosing~PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM.~Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus"
11389182|NCT03116685|BG000|Baseline|Oxabact OC5 Capsules|"Oxabact OC5 - Oxalobacter formigenes HC-1~Oxabact OC5 - Oxalobacter formigenes HC-1: Active study drug"
11389183|NCT03116685|BG001|Baseline|Placebo Capsules|"Placebo~Placebo: Placebo"
11389184|NCT03116685|BG002|Baseline|Total|Total of all reporting groups
11389185|NCT03116685|FG000|Participant Flow|Oxabact OC5 Capsules|"Oxabact OC5 - Oxalobacter formigenes HC-1~Oxabact OC5 - Oxalobacter formigenes HC-1: Active study drug"
11389186|NCT03116685|FG001|Participant Flow|Placebo Capsules|"Placebo~Placebo: Placebo"
11389187|NCT03116685|OG000|Outcome|Oxabact OC5 Capsules|"Oxabact OC5 - Oxalobacter formigenes HC-1~Oxabact OC5 - Oxalobacter formigenes HC-1: Active study drug"
11389188|NCT03116685|OG001|Outcome|Placebo Capsules|"Placebo~Placebo: Placebo"
11389189|NCT03116685|EG000|Reported Event|Oxabact OC5 Capsules|"Oxabact OC5 - Oxalobacter formigenes HC-1~Oxabact OC5 - Oxalobacter formigenes HC-1: Active study drug"
11389190|NCT03116685|EG001|Reported Event|Placebo Capsules|"Placebo~Placebo: Placebo"
11389191|NCT03099304|BG000|Baseline|Vehicle Twice Daily (BID)|Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389192|NCT03099304|BG001|Baseline|Ruxolitinib Cream 0.15% Once Daily (QD)|Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389193|NCT03099304|BG002|Baseline|Ruxolitinib Cream 0.5% Once Daily (QD)|Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389194|NCT03099304|BG003|Baseline|Ruxolitinib Cream 1.5% Once Daily (QD)|Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389195|NCT03099304|BG004|Baseline|Ruxolitinib Cream 1.5% Twice Daily (BID)|Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389196|NCT03099304|BG005|Baseline|Total|Total of all reporting groups
11389197|NCT03099304|FG000|Participant Flow|Vehicle Twice Daily (BID)|Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389198|NCT03099304|FG001|Participant Flow|Ruxolitinib Cream 0.15% Once Daily (QD)|Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389199|NCT03099304|FG002|Participant Flow|Ruxolitinib Cream 0.5% Once Daily (QD)|Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389200|NCT03099304|FG003|Participant Flow|Ruxolitinib Cream 1.5% Once Daily (QD)|Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389201|NCT03099304|FG004|Participant Flow|Ruxolitinib Cream 1.5% Twice Daily (BID)|Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389202|NCT03099304|OG000|Outcome|Vehicle Twice Daily (BID)|Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389203|NCT03099304|OG001|Outcome|Ruxolitinib Cream 0.15% QD|Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389204|NCT03099304|OG002|Outcome|Ruxolitinib Cream 0.5% QD|Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
10965846|NCT00884286|FG000|Participant Flow|Aplidin® (Cohort Non-cutaneous PTCL)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389205|NCT03099304|OG003|Outcome|Ruxolitinib Cream 1.5% Once Daily (QD)|Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389206|NCT03099304|OG004|Outcome|Ruxolitinib Cream 1.5% Twice Daily (BID)|Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389207|NCT03099304|OG000|Outcome|Ruxolitinib Cream 0.15% QD|Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks in participants who saw greater than 25% improvement in F-VASI score at week 24.
11389208|NCT03099304|OG001|Outcome|Ruxoltinib Cream 0.5% QD|Subjects who were randomized to 0.15% QD and vehicle groups in vehicle-controlled period (Day 1 to Week 24) crossed over to Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks.
11389209|NCT03099304|OG002|Outcome|Ruxolitinib Cream 1.5% QD|Subjects who were randomized to 1.5% QD and vehicle groups in vehicle-controlled period (Day 1 to Week 24) crossed over to Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks.
11389210|NCT03099304|OG003|Outcome|Ruxolitinib Cream 1.5% BID|Subjects who were randomized to 1.5% BID and vehicle groups in vehicle-controlled period (Day 1 to Week 24) crossed over to Ruxolitinib cream 1.5% BID in the morning (vehicle cream in the evening) for 52 weeks.
11389211|NCT03099304|OG004|Outcome|Ruxolitinib Cream 0.5% QD|Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389212|NCT03099304|OG005|Outcome|Ruxolitinib Cream 1.5% Once Daily (QD)|Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389213|NCT03099304|OG006|Outcome|Ruxolitinib Cream 1.5% Twice Daily (BID)|Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389214|NCT03099304|EG000|Reported Event|Vehicle Twice Daily (BID)|Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
11389215|NCT03099304|EG001|Reported Event|INCB018424 0.15% Once Daily (QD)|INCB018424 0.15% QD
11389216|NCT03099304|EG002|Reported Event|INCB018424 0.5% Once Daily (QD)|INCB018424 0.5% QD
11389217|NCT03099304|EG003|Reported Event|INCB018424 1.5% Once Daily (QD)|INCB018424 1.5% QD
11389218|NCT03099304|EG004|Reported Event|INCB018424 1.5% Twice Daily (BID)|INCB018424 1.5% BID
11389219|NCT03034863|BG000|Baseline|SAFER|"SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.~Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation."
11389220|NCT03034863|BG001|Baseline|I-SPI|"The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), the currently mandated Individual Safety Planning Intervention (I-SPI). I-SPI incorporates weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran's primary mental health provider.~Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI)."
11389221|NCT03034863|BG002|Baseline|Total|Total of all reporting groups
11389222|NCT03034863|FG000|Participant Flow|SAFER|"Safe Actions for Families to Encourage Recovery (SAFER): A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.~Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation."
11389223|NCT03034863|FG001|Participant Flow|I-SPI|"The comparison condition will be an assessment-only enhanced treatment-as-usual, the currently mandated Individual Safety Planning Intervention (I-SPI). I-SPI incorporates update and use of the safety plan, which will then be uploaded to the Computerized Patient Record System (CPRS) so the Veterans' primary mental health providers can access.~Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI)."
11389224|NCT03034863|OG000|Outcome|Veterans in SAFER|Veteran participants in the SAFER (intervention) condition
11389225|NCT03034863|OG001|Outcome|Veterans in I-SPI|Veterans in the I-SPI (control) condition
11389226|NCT03034863|OG000|Outcome|Caregivers in SAFER|Caregivers in the SAFER (intervention) condition
11389227|NCT03034863|OG001|Outcome|Caregivers in I-SPI|Caregivers in the I-SPI (control) condition
11389228|NCT03034863|OG000|Outcome|Veterans in SAFER|Veteran participants in the SAFER (treatment) condition
11389229|NCT03034863|EG000|Reported Event|SAFER: Veterans|"SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.~Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation."
11389230|NCT03034863|EG001|Reported Event|I-SPI: Veterans|"The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access.~Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU)."
11389231|NCT03034863|EG002|Reported Event|SAFER: Caregivers|SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
11389232|NCT03034863|EG003|Reported Event|I-SPI: Caregivers|"The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access.~Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU)."
11389233|NCT02819050|BG000|Baseline|Sprinting|"Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)~NCPAP: Nasal Continuous Positive Airway Pressure"
11389234|NCT02819050|BG001|Baseline|Non-Sprinting|"If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~NCPAP: Nasal Continuous Positive Airway Pressure"
11389235|NCT02819050|BG002|Baseline|Total|Total of all reporting groups
11389236|NCT02819050|FG000|Participant Flow|Sprinting|"Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)~NCPAP: Nasal Continuous Positive Airway Pressure"
11389237|NCT02819050|FG001|Participant Flow|Non-Sprinting|"If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~NCPAP: Nasal Continuous Positive Airway Pressure"
11389238|NCT02819050|OG000|Outcome|Sprinting|"Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)~NCPAP: Nasal Continuous Positive Airway Pressure"
11389239|NCT02819050|OG001|Outcome|Non-Sprinting|"If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~NCPAP: Nasal Continuous Positive Airway Pressure"
11389240|NCT02819050|OG000|Outcome|Non-Sprinting|"If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~NCPAP: Nasal Continuous Positive Airway Pressure"
11389241|NCT02819050|OG001|Outcome|Sprinting|"Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)~NCPAP: Nasal Continuous Positive Airway Pressure"
11389242|NCT02819050|EG000|Reported Event|Sprinting|"Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)~NCPAP: Nasal Continuous Positive Airway Pressure"
11389243|NCT02819050|EG001|Reported Event|Non-Sprinting|"If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.~NCPAP: Nasal Continuous Positive Airway Pressure"
11389244|NCT02682901|BG000|Baseline|Cycloset (Bromocriptine-QR)|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus bromocriptine-QR. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (0.8 mg bromocriptine-QR) per day on a weekly basis until a maximal tolerated dose of at least two tablets (1.6 mg/day bromocriptine-QR) and no more than four tablets (3.2 mg/per day b-QR) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (1.6 to 3.2 mg bromocriptine-QR per day) for the duration of the study (24 weeks). Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Cycloset: Cycloset 1.6 -3.2 mg/day"
11389245|NCT02682901|BG001|Baseline|Placebo|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus placebo. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (1 matching placebo tablet) per day on a weekly basis until a maximal tolerated dose of at least two tablets (2 placebo tablets) and no more than four tablets (4 placebo tablets) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (2 to 4 placebo tablets) for the duration of the study. Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Placebo: Non-active placebo for cycloset"
11389246|NCT02682901|BG002|Baseline|Total|Total of all reporting groups
11389247|NCT02682901|FG000|Participant Flow|Cycloset (Bromocriptine-QR)|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus bromocriptine-QR. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (0.8 mg bromocriptine-QR) per day on a weekly basis until a maximal tolerated dose of at least two tablets (1.6 mg/day bromocriptine-QR) and no more than four tablets (3.2 mg/per day b-QR) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (1.6 to 3.2 mg bromocriptine-QR per day) for the duration of the study (24 weeks). Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Cycloset: Cycloset 1.6 -3.2 mg/day"
11389248|NCT02682901|FG001|Participant Flow|Placebo|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus placebo. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (1 matching placebo tablet) per day on a weekly basis until a maximal tolerated dose of at least two tablets (2 placebo tablets) and no more than four tablets (4 placebo tablets) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (2 to 4 placebo tablets) for the duration of the study. Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Placebo: Non-active placebo for cycloset"
11389249|NCT02682901|OG000|Outcome|Cycloset (Bromocriptine-QR)|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus bromocriptine-QR. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (0.8 mg bromocriptine-QR) per day on a weekly basis until a maximal tolerated dose of at least two tablets (1.6 mg/day bromocriptine-QR) and no more than four tablets (3.2 mg/per day b-QR) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (1.6 to 3.2 mg bromocriptine-QR per day) for the duration of the study (24 weeks). Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Cycloset: Cycloset 1.6 -3.2 mg/day"
11389250|NCT02682901|OG001|Outcome|Placebo|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus placebo. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (1 matching placebo tablet) per day on a weekly basis until a maximal tolerated dose of at least two tablets (2 placebo tablets) and no more than four tablets (4 placebo tablets) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (2 to 4 placebo tablets) for the duration of the study. Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Placebo: Non-active placebo for cycloset"
11389251|NCT02682901|EG000|Reported Event|Cycloset (Bromocriptine-QR)|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus bromocriptine-QR. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (0.8 mg bromocriptine-QR) per day on a weekly basis until a maximal tolerated dose of at least two tablets (1.6 mg/day bromocriptine-QR) and no more than four tablets (3.2 mg/per day b-QR) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (1.6 to 3.2 mg bromocriptine-QR per day) for the duration of the study (24 weeks). Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Cycloset: Cycloset 1.6 -3.2 mg/day"
11389252|NCT02682901|EG001|Reported Event|Placebo|"Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus placebo. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (1 matching placebo tablet) per day on a weekly basis until a maximal tolerated dose of at least two tablets (2 placebo tablets) and no more than four tablets (4 placebo tablets) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (2 to 4 placebo tablets) for the duration of the study. Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).~Placebo: Non-active placebo for cycloset"
11389253|NCT02567825|BG000|Baseline|Surgical Management|"Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops~Tympanostomy tube placement: As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.~Ofloxacin Otic: Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later."
11389254|NCT02567825|BG001|Baseline|Non-Surgical Management|"Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone~Amoxicillin-Clavulanate and/or Ceftriaxone: Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines."
11389255|NCT02567825|BG002|Baseline|Total|Total of all reporting groups
11389256|NCT02567825|FG000|Participant Flow|Surgical Management|"Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops~Tympanostomy tube placement: As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.~Ofloxacin Otic: Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later."
11389257|NCT02567825|FG001|Participant Flow|Non-Surgical Management|"Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone~Amoxicillin-Clavulanate and/or Ceftriaxone: Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines."
11389258|NCT02567825|OG000|Outcome|Surgical Management|"Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops~Tympanostomy tube placement: As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.~Ofloxacin Otic: Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later."
11389259|NCT02567825|OG001|Outcome|Non-Surgical Management|"Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone~Amoxicillin-Clavulanate and/or Ceftriaxone: Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines."
10800126|NCT02527434|FG001|Participant Flow|TNBC Cohort|"Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
11389260|NCT02567825|EG000|Reported Event|Surgical Management|"Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops~Tympanostomy tube placement: As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.~Ofloxacin Otic: Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later."
11389261|NCT02567825|EG001|Reported Event|Non-Surgical Management|"Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone~Amoxicillin-Clavulanate and/or Ceftriaxone: Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines."
11389262|NCT02555657|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to ~1 year).
11389263|NCT02555657|BG001|Baseline|Chemotherapy|Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
11389264|NCT02555657|BG002|Baseline|Total|Total of all reporting groups
11389265|NCT02555657|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to ~1 year).
11389266|NCT02555657|FG001|Participant Flow|Chemotherapy|Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
11389267|NCT02555657|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).
11389268|NCT02555657|OG001|Outcome|Chemotherapy|Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
11389269|NCT02555657|EG000|Reported Event|Pembrolizumab First Course|Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to ~2 years).
11389270|NCT02555657|EG001|Reported Event|Chemotherapy|Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
11389271|NCT02555657|EG002|Reported Event|Pembrolizumab Second Course|Qualified participants who received the first course of pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to ~2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 17 administrations (up to ~1 year).
11389272|NCT02190721|BG000|Baseline|Infants (1 Month to <2 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389273|NCT02190721|BG001|Baseline|Children (2 to <12 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389274|NCT02190721|BG002|Baseline|Adolescents (12 to <16 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389275|NCT02190721|BG003|Baseline|Total|Total of all reporting groups
11389276|NCT02190721|FG000|Participant Flow|Infants (1 Month to <2 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389277|NCT02190721|FG001|Participant Flow|Children (2 to <12 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389278|NCT02190721|FG002|Participant Flow|Adolescents (12 to <16 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389279|NCT02190721|OG000|Outcome|Infants (1 Month to <2 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389280|NCT02190721|OG001|Outcome|Children (2 to <12 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389281|NCT02190721|OG002|Outcome|Adolescents (12 to <16 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389282|NCT02190721|EG000|Reported Event|Infants (1 Month to <2 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389283|NCT02190721|EG001|Reported Event|Children (2 to <12 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389284|NCT02190721|EG002|Reported Event|Adolescents (12 to <16 Years)|Tbo-filgrastim administration was started at approximately 24 hours (±3 hours) after the end of the last chemotherapy (CTX) treatment in the first week of the CTX cycle. Daily dosing with tbo-filgrastim at a dose of 5 μg/kg/day of body weight continued until the expected neutrophil nadir was passed and the neutrophil count had recovered to 2.0 × 10^9/L but not longer than 14 consecutive days. An immunogenicity sample was collected 30 days and 3 months after the last tbo-filgrastim administration in the first cycle.
11389285|NCT00908687|BG000|Baseline|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
11389286|NCT00908687|BG001|Baseline|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389287|NCT00908687|BG002|Baseline|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389288|NCT00908687|BG003|Baseline|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
11389289|NCT00908687|BG004|Baseline|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389290|NCT00908687|BG005|Baseline|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389291|NCT00908687|BG006|Baseline|Total|Total of all reporting groups
11389292|NCT00908687|FG000|Participant Flow|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
11389293|NCT00908687|FG001|Participant Flow|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389294|NCT00908687|FG002|Participant Flow|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389295|NCT00908687|FG003|Participant Flow|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
11389296|NCT00908687|FG004|Participant Flow|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389297|NCT00908687|FG005|Participant Flow|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389298|NCT00908687|OG000|Outcome|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
11389299|NCT00908687|OG001|Outcome|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389300|NCT00908687|OG002|Outcome|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389301|NCT00908687|OG003|Outcome|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
11389302|NCT00908687|OG004|Outcome|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389303|NCT00908687|OG005|Outcome|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389304|NCT00908687|EG000|Reported Event|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
11389305|NCT00908687|EG001|Reported Event|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389306|NCT00908687|EG002|Reported Event|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389307|NCT00908687|EG003|Reported Event|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
11389308|NCT00908687|EG004|Reported Event|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
11389309|NCT00908687|EG005|Reported Event|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
11389310|NCT00739401|BG000|Baseline|Suprarenal Proximal Cuff Extension|"Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.~Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft"
11389311|NCT00739401|FG000|Participant Flow|Suprarenal Proximal Cuff Extension|"Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.~Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft"
11389312|NCT00739401|OG000|Outcome|Suprarenal Proximal Cuff Extension|"Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.~Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft"
11389313|NCT00739401|EG000|Reported Event|Suprarenal Proximal Cuff Extension|"Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.~Suprarenal Proximal Cuff Extension: Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft"
11389314|NCT00651742|BG000|Baseline|S-1 30 mg/m^2|Participants received 30 mg/m^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
11389315|NCT00651742|FG000|Participant Flow|S-1 30 mg/m^2|Participants received 30 milligrams per meter square (mg/m^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
11389316|NCT00651742|OG000|Outcome|S-1 30 mg/m^2|Participants received 30 mg/m^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
11389317|NCT00651742|EG000|Reported Event|S-1 30 mg/m^2|Participants received 30 mg/m^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
11389318|NCT00308516|BG000|Baseline|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389319|NCT00308516|BG001|Baseline|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389320|NCT00308516|BG002|Baseline|Total|Total of all reporting groups
11389321|NCT00308516|FG000|Participant Flow|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389322|NCT00308516|FG001|Participant Flow|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389323|NCT00308516|OG000|Outcome|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389324|NCT00308516|OG001|Outcome|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389325|NCT00308516|EG000|Reported Event|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389326|NCT00308516|EG001|Reported Event|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
11389327|NCT04331366|BG000|Baseline|GO2 PEEP MOUTHPIECE|Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
11389328|NCT04331366|FG000|Participant Flow|GO2 PEEP MOUTHPIECE|Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
11389329|NCT04331366|OG000|Outcome|GO2 PEEP MOUTHPIECE|Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
11389330|NCT04331366|EG000|Reported Event|GO2 PEEP MOUTHPIECE|Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
11389331|NCT04930263|BG000|Baseline|Aerobic Exercise|"Behavioral: walking exercise~The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section~individualized education~telephone and social media counselling~booklet guidance~Aerobic exercise: The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down."
11389332|NCT04930263|BG001|Baseline|Control Group|Given routine care and life health manual for the participants.
11389333|NCT04930263|BG002|Baseline|Total|Total of all reporting groups
11389334|NCT04930263|FG000|Participant Flow|Aerobic Exercise|"Behavioral: walking exercise~The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section~individualized education~telephone and social media counselling~booklet guidance~Aerobic exercise: The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down."
11389335|NCT04930263|FG001|Participant Flow|Control Group|Given routine care and life health manual for the participants.
11389336|NCT04930263|OG000|Outcome|Aerobic Exercise|"Behavioral: walking exercise~The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section~individualized education~telephone and social media counselling~booklet guidance~Aerobic exercise: The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down."
11389337|NCT04930263|OG001|Outcome|Control Group|Given routine care and life health manual for the participants.
11389338|NCT04930263|EG000|Reported Event|Aerobic Exercise|"Behavioral: walking exercise~The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section~individualized education~telephone and social media counselling~booklet guidance~Aerobic exercise: The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down."
11389339|NCT04930263|EG001|Reported Event|Control Group|Given routine care and life health manual for the participants.
11389340|NCT04321252|BG000|Baseline|Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)|Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
11389341|NCT04321252|BG001|Baseline|Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)|Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
11389342|NCT04321252|BG002|Baseline|Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)|Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
11389343|NCT04321252|BG003|Baseline|Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)|Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
11389344|NCT04321252|BG004|Baseline|Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)|Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
11389345|NCT04321252|BG005|Baseline|Part A (Single-ascending Dose (SAD): Pooled Placebo|All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11389346|NCT04321252|BG006|Baseline|Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)|Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389347|NCT04321252|BG007|Baseline|Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)|Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389348|NCT04321252|BG008|Baseline|Part B (Multiple-ascending Dose (MAD): Pooled Placebo|All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389349|NCT04321252|BG009|Baseline|Total|Total of all reporting groups
11389350|NCT04321252|FG000|Participant Flow|Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)|Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
11389351|NCT04321252|FG001|Participant Flow|Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)|Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
11389352|NCT04321252|FG002|Participant Flow|Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)|Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
11389353|NCT04321252|FG003|Participant Flow|Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)|Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
11389354|NCT04321252|FG004|Participant Flow|Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)|Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
11389355|NCT04321252|FG005|Participant Flow|Part A (Single-ascending Dose (SAD): Pooled Placebo|All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11389356|NCT04321252|FG006|Participant Flow|Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)|Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389357|NCT04321252|FG007|Participant Flow|Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)|Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389358|NCT04321252|FG008|Participant Flow|Part B (Multiple-ascending Dose (MAD): Pooled Placebo|All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389359|NCT04321252|OG000|Outcome|Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)|Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
11389360|NCT04321252|OG001|Outcome|Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)|Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
11389361|NCT04321252|OG002|Outcome|Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)|Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
11389362|NCT04321252|OG003|Outcome|Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)|Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
11389363|NCT04321252|OG004|Outcome|Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)|Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
11389364|NCT04321252|OG005|Outcome|Part A (Single-ascending Dose (SAD): Pooled KAE609|All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11389365|NCT04321252|OG006|Outcome|Part A (Single-ascending Dose (SAD): Pooled Placebo|All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11389366|NCT04321252|OG007|Outcome|Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)|Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389367|NCT04321252|OG008|Outcome|Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)|Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389368|NCT04321252|OG009|Outcome|Part B (Multiple-ascending Dose (MAD): Pooled KAE609|All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389369|NCT04321252|OG010|Outcome|Part B (Multiple-ascending Dose (MAD): Pooled Placebo|All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389370|NCT04321252|OG000|Outcome|Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)|Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389371|NCT04321252|OG001|Outcome|Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)|Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389372|NCT04321252|EG000|Reported Event|Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)|Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
11389373|NCT04321252|EG001|Reported Event|Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)|Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
11389374|NCT04321252|EG002|Reported Event|Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)|Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
11389375|NCT04321252|EG003|Reported Event|Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)|Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
11389376|NCT04321252|EG004|Reported Event|Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)|Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
11389377|NCT04321252|EG005|Reported Event|Part A (Single-ascending Dose (SAD): Pooled KAE609|All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11197436|NCT02171065|OG000|Outcome|Guideline Directed Medical Therapy (GDMT) in PROSPECT-ABSORB and PROSPECT II|Patient were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.
11197437|NCT02171065|OG001|Outcome|ABSORB + GDMT in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB + BVS + GDMT group. Patients remain in PROSPECT II cohort.
11197438|NCT02171065|OG002|Outcome|PROSPECT II Only|Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
11197439|NCT02171065|OG000|Outcome|Guideline Directed Medical Therapy|Guideline Directed Medical Therapy
11197440|NCT02171065|OG001|Outcome|ABSORB BVS + Guideline Directed Medical Therapy|ABSORB BVS + Guideline Directed Medical Therapy
11389378|NCT04321252|EG006|Reported Event|Part A (Single-ascending Dose (SAD): Pooled Placebo|All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
11389379|NCT04321252|EG007|Reported Event|Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)|Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389380|NCT04321252|EG008|Reported Event|Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)|Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
11389381|NCT04321252|EG009|Reported Event|Part B (Multiple-ascending Dose (MAD): Pooled KAE609|All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389382|NCT04321252|EG010|Reported Event|Part B (Multiple-ascending Dose (MAD): Pooled Placebo|All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
11389383|NCT04285684|BG000|Baseline|Ketamine During Lactation|Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
11389384|NCT04285684|FG000|Participant Flow|Ketamine During Lactation|Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
11389385|NCT04285684|OG000|Outcome|Ketamine During Lactation|Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
11389386|NCT04285684|EG000|Reported Event|Ketamine During Lactation|Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
11389387|NCT04176445|BG000|Baseline|All Study Participants|"Study participants were randomized to Bedside sitting (first intervention) posture protocol followed by orthostatic board (second intervention) posture protocol or Orthostatic board (first intervention) posture protocol followed by bedside sitting posture (second intervention) protocol.~Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes~Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes."
11389388|NCT04176445|FG000|Participant Flow|Bedside Sitting (First Intervention) Followed by Orthostatic Board (Second Intervention)|"Bedside sitting posture protocol followed by orthostatic board posture protocol.~Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes~Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes."
11197441|NCT02171065|EG000|Reported Event|Guideline Directed Medical Therapy in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to GDMT group. Patients remain in PROSPECT II cohort.
11197442|NCT02171065|EG001|Reported Event|ABSORB BVS + GDMT in PROSPECT-ABSORB and PROSPECT II|Patients were enrolled in PROSPECT-ABSORB and randomized to ABSORB-BVS + GDMT group. Patients remain in PROSPECT II cohort.
11197443|NCT02171065|EG002|Reported Event|PROSPECT II Only|Patients were not enrolled in PROSPECT-ABSORB. Patients remain in PROSPECT II.
11197444|NCT02171130|BG000|Baseline|Nasal Glucagon|Nasal Glucagon powder (3mg)
11197445|NCT02171130|FG000|Participant Flow|Nasal Glucagon (NG)|Nasal Glucagon powder (3 milligram [mg])
11197446|NCT02171130|OG000|Outcome|Nasal Glucagon|Nasal Glucagon powder (3mg)
11197447|NCT02171130|EG000|Reported Event|Nasal Glucagon|Nasal Glucagon powder (3mg)
11197448|NCT02171195|BG000|Baseline|Placebo|Placebo, PLC
11197449|NCT02171195|BG001|Baseline|Group 1 20 mg|BIA 2-093 20mg or placebo.
11197450|NCT02171195|BG002|Baseline|Group 2 50 mg|BIA 2-093 50mg or placebo
11197451|NCT02171195|BG003|Baseline|Group 3 100 mg|BIA 2-093 100mg or placebo
11197452|NCT02171195|BG004|Baseline|Group 4 200 mg|BIA 2-093 200mg or placebo
11197453|NCT02171195|BG005|Baseline|Group 5 400 mg|BIA 2-093 or 400mg or placebo
11389389|NCT04176445|FG001|Participant Flow|Orthostatic Board (First Intervention) Followed by Bedside Sitting (Second Intervention)|"Orthostatic board posture protocol followed by bedside sitting posture protocol.~Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes~Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes."
11389390|NCT04176445|OG000|Outcome|Bedside Sitting|Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.
11389391|NCT04176445|OG001|Outcome|Orthostatic Board|Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
11389392|NCT04176445|EG000|Reported Event|Bedside Sitting|Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.
11389393|NCT04176445|EG001|Reported Event|Orthostatic Board|Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
11389394|NCT04126213|BG000|Baseline|RSV MAT 60 Group-Mother|Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
11389395|NCT04126213|BG001|Baseline|RSV MAT 120 Group-Mother|Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
11389396|NCT04126213|BG002|Baseline|Control Group-Mother|Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
11389397|NCT04126213|BG003|Baseline|RSV MAT 60 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
11389398|NCT04126213|BG004|Baseline|RSV MAT 120 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
11389399|NCT04126213|BG005|Baseline|Control Group-Infant|This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
11389400|NCT04126213|BG006|Baseline|Total|Total of all reporting groups
11389401|NCT04126213|FG000|Participant Flow|RSV MAT 60 Group-Mother|Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
11389402|NCT04126213|FG001|Participant Flow|RSV MAT 120 Group-Mother|Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
11389403|NCT04126213|FG002|Participant Flow|Control Group-Mother|Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
11389404|NCT04126213|FG003|Participant Flow|RSV MAT 60 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
11389405|NCT04126213|FG004|Participant Flow|RSV MAT 120 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
11389406|NCT04126213|FG005|Participant Flow|Control Group-Infant|This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
11389407|NCT04126213|OG000|Outcome|RSV MAT 60 Group-Mother|Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
11389408|NCT04126213|OG001|Outcome|RSV MAT 120 Group-Mother|Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
11389409|NCT04126213|OG002|Outcome|Control Group-Mother|Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
11389410|NCT04126213|OG000|Outcome|RSV MAT 60 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
11389411|NCT04126213|OG001|Outcome|RSV MAT 120 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
11389412|NCT04126213|OG002|Outcome|Control Group-Infant|This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
11389413|NCT04126213|OG000|Outcome|RSV MAT 60 Group|This group consisted of pairs of maternal subjects from RSV MAT 60- Mother Group and infant subjects from RSV MAT 60-Infants Group.
11389414|NCT04126213|OG001|Outcome|RSV MAT 120 Group|This group consisted of pairs of maternal subjects from RSV MAT 120- Mother Group and infant subjects from RSV MAT 120-Infants Group.
11389415|NCT04126213|OG002|Outcome|Control Group|This group consisted of pairs of maternal subjects from Control- Mother Group and infant subjects from Control-Infants Group.
11389416|NCT04126213|EG000|Reported Event|RSV MAT 60 Group-Mother|Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
11389417|NCT04126213|EG001|Reported Event|RSV MAT 120 Group-Mother|Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
11389418|NCT04126213|EG002|Reported Event|Control Group-Mother|Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
11389419|NCT04126213|EG003|Reported Event|RSV MAT 60 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
11389420|NCT04126213|EG004|Reported Event|RSV MAT 120 Group-Infant|This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
11197454|NCT02171195|BG006|Baseline|Group 6 600 mg|BIA 2-093 600mg or placebo
11197455|NCT02171195|BG007|Baseline|Group 7 900 mg|BIA 2-093 900mg or placebo
11197456|NCT02171195|BG008|Baseline|Group 8 1200 mg|BIA 2-093 1200mg or placebo
11389421|NCT04126213|EG005|Reported Event|Control Group-Infant|This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
11389422|NCT03916458|BG000|Baseline|Sunitinib|Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
11389423|NCT03916458|FG000|Participant Flow|Sunitinib|Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 milligrams (mg) capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
11389424|NCT03916458|OG000|Outcome|Sunitinib|Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
11389425|NCT03916458|EG000|Reported Event|Sunitinib|Participants who received sunitinib as first line therapy (treatment with prior cytokine therapy was accepted) in real world clinical practices, between 2007 and 30 October 2018, either alone or with subsequent local treatment (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) and achieved a complete response were observed in the study. The participants were administered with sunitinib 50 mg capsule orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (4/2 regimen) or 2 weeks on treatment followed by 1 week off treatment (2/1 regimen), or with 37.5 mg capsule orally once daily of 4/2 regimen.
11389426|NCT03672188|BG000|Baseline|Part A: SAD VIR-2218 50 mg|"Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389427|NCT03672188|BG001|Baseline|Part A: SAD VIR-2218 100 mg|"Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389428|NCT03672188|BG002|Baseline|Part A: SAD VIR-2218 200 mg|"Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389429|NCT03672188|BG003|Baseline|Part A: SAD VIR-2218 400 mg|"Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389430|NCT03672188|BG004|Baseline|Part A: SAD VIR-2218 600 mg|"Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389431|NCT03672188|BG005|Baseline|Part A: SAD VIR-2218 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389432|NCT03672188|BG006|Baseline|Part A: SAD Placebo|"Healthy subjects received a single dose of placebo administered SC~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389433|NCT03672188|BG007|Baseline|Part B: MAD VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389434|NCT03672188|BG008|Baseline|Part B: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389435|NCT03672188|BG009|Baseline|Part B: MAD VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389436|NCT03672188|BG010|Baseline|Part B: MAD VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389437|NCT03672188|BG011|Baseline|Part C: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389438|NCT03672188|BG012|Baseline|Part C: MAD VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389439|NCT03672188|BG013|Baseline|Part B: MAD Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11197457|NCT02171195|BG009|Baseline|Total|Total of all reporting groups
11197458|NCT02171195|FG000|Participant Flow|Placebo|Placebo, PLC
11197459|NCT02171195|FG001|Participant Flow|Group 1 20 mg|BIA 2-093 20mg or placebo.
11197460|NCT02171195|FG002|Participant Flow|Group 2 50 mg|BIA 2-093 50mg or placebo
11197461|NCT02171195|FG003|Participant Flow|Group 3 100 mg|BIA 2-093 100mg or placebo
11197462|NCT02171195|FG004|Participant Flow|Group 4 200 mg|BIA 2-093 200mg or placebo
11197463|NCT02171195|FG005|Participant Flow|Group 5 400 mg|BIA 2-093 or 400mg or placebo
11197464|NCT02171195|FG006|Participant Flow|Group 6 600 mg|BIA 2-093 600mg or placebo
11197465|NCT02171195|FG007|Participant Flow|Group 7 900 mg|BIA 2-093 900mg or placebo
11197466|NCT02171195|FG008|Participant Flow|Group 8 1200 mg|BIA 2-093 1200mg or placebo
11197467|NCT02171195|OG000|Outcome|Placebo|Placebo, PLC
11389440|NCT03672188|BG014|Baseline|Part C: MAD Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389441|NCT03672188|BG015|Baseline|Total|Total of all reporting groups
11389442|NCT03672188|FG000|Participant Flow|Part A: SAD VIR-2218 50 mg|"Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389443|NCT03672188|FG001|Participant Flow|Part A: SAD VIR-2218 100 mg|"Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389444|NCT03672188|FG002|Participant Flow|Part A: SAD VIR-2218 200 mg|"Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389445|NCT03672188|FG003|Participant Flow|Part A: SAD VIR-2218 400 mg|"Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389446|NCT03672188|FG004|Participant Flow|Part A: SAD VIR-2218 600 mg|"Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389447|NCT03672188|FG005|Participant Flow|Part A SAD VIR-2218 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389448|NCT03672188|FG006|Participant Flow|Part A: SAD Placebo|"Healthy subjects received a single dose of placebo administered SC~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389449|NCT03672188|FG007|Participant Flow|Part B: MAD VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389450|NCT03672188|FG008|Participant Flow|Part B: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389451|NCT03672188|FG009|Participant Flow|Part B: MAD VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389452|NCT03672188|FG010|Participant Flow|Part B: MAD VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389453|NCT03672188|FG011|Participant Flow|Part C: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389454|NCT03672188|FG012|Participant Flow|Part C: MAD 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389455|NCT03672188|FG013|Participant Flow|Part B: MAD Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389456|NCT03672188|FG014|Participant Flow|Part C: MAD Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389457|NCT03672188|OG000|Outcome|Part A: SAD VIR-2218 50 mg|"Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389458|NCT03672188|OG001|Outcome|Part A: SAD VIR-2218 100 mg|"Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389459|NCT03672188|OG002|Outcome|Part A: SAD VIR-2218 200 mg|"Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389460|NCT03672188|OG003|Outcome|Part A: SAD VIR-2218 400 mg|"Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389461|NCT03672188|OG004|Outcome|Part A: SAD VIR-2218 600 mg|"Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389462|NCT03672188|OG005|Outcome|Part A: SAD VIR-2219 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389463|NCT03672188|OG006|Outcome|Part A: SAD Placebo|"Healthy subjects received a single dose of placebo administered SC~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389464|NCT03672188|OG007|Outcome|Part B: MAD VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389465|NCT03672188|OG008|Outcome|Part B: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389466|NCT03672188|OG009|Outcome|Part B: MAD VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389467|NCT03672188|OG010|Outcome|Part B: MAD VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389468|NCT03672188|OG011|Outcome|Part C: MAD VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389469|NCT03672188|OG012|Outcome|Part C: MAD VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389470|NCT03672188|OG013|Outcome|Part B: MAD Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389471|NCT03672188|OG014|Outcome|Part C: MAD Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389472|NCT03672188|OG005|Outcome|Part A: SAD VIR-2218 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389473|NCT03672188|OG006|Outcome|Part B/C: MAD VIR-2218 20 mg|"Chronic HBV subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389474|NCT03672188|OG007|Outcome|Part B/C: MAD VIR-2218 50 mg|"Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389475|NCT03672188|OG008|Outcome|Part B/C: MAD VIR-2218 100 mg|"Chronic HBV, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389476|NCT03672188|OG009|Outcome|Parts B/C: MAD VIR-2218 200 mg|"Chronic HBV subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389477|NCT03672188|OG006|Outcome|Part B/C: MAD VIR-2218 20 mg|"Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389478|NCT03672188|OG008|Outcome|Part B/C: MAD VIR-2218 100 mg|"Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389479|NCT03672188|OG009|Outcome|Part B/C: MAD VIR-2218 200 mg|"Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389480|NCT03672188|OG006|Outcome|Part B/C: MAD VIR-2218 20mg|"Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389481|NCT03672188|OG000|Outcome|Part A SAD: VIR-2218 50 mg|"Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389482|NCT03672188|OG001|Outcome|Part A SAD: VIR-2218 100 mg|"Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389483|NCT03672188|OG002|Outcome|Part A SAD: VIR-2218 200 mg|"Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389484|NCT03672188|OG003|Outcome|Part A SAD: VIR-2218 400 mg|"Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389485|NCT03672188|OG004|Outcome|Part A SAD: VIR-2218 600 mg|"Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389486|NCT03672188|OG005|Outcome|Part A SAD: VIR-2218 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389487|NCT03672188|OG000|Outcome|Part B MAD: VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389488|NCT03672188|OG001|Outcome|Part B MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389489|NCT03672188|OG002|Outcome|Part B MAD: VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389490|NCT03672188|OG003|Outcome|Part B MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389491|NCT03672188|OG004|Outcome|Part C MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389492|NCT03672188|OG005|Outcome|Part C MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389493|NCT03672188|OG006|Outcome|Part B MAD: Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389494|NCT03672188|OG007|Outcome|Part C MAD: Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart~VIR-2218: VIR-2218 given by subcutaneous injection"
11389495|NCT03672188|OG001|Outcome|Part B MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389496|NCT03672188|OG002|Outcome|Part B MAD: VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389497|NCT03672188|OG003|Outcome|Part B MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389498|NCT03672188|OG004|Outcome|Part C MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389499|NCT03672188|OG005|Outcome|Part C MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389500|NCT03672188|OG006|Outcome|Part B MAD: Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389501|NCT03672188|OG007|Outcome|Part C MAD: Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389502|NCT03672188|OG000|Outcome|Part B MAD: VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389503|NCT03672188|OG000|Outcome|Part C MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389504|NCT03672188|OG001|Outcome|Part C MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389505|NCT03672188|OG002|Outcome|Part C MAD: Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11197468|NCT02171195|OG001|Outcome|Group 1 20 mg|BIA 2-093 20mg or placebo.
11197469|NCT02171195|OG002|Outcome|Group 2 50 mg|BIA 2-093 50mg or placebo
11197470|NCT02171195|OG003|Outcome|Group 3 100 mg|BIA 2-093 100mg or placebo
11197471|NCT02171195|OG004|Outcome|Group 4 200 mg|BIA 2-093 200mg or placebo
11197472|NCT02171195|OG005|Outcome|Group 5 400 mg|BIA 2-093 or 400mg or placebo
11197473|NCT02171195|OG006|Outcome|Group 6 600 mg|BIA 2-093 600mg or placebo
11389506|NCT03672188|EG000|Reported Event|Part A SAD: VIR-2218 50 mg|"Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389507|NCT03672188|EG001|Reported Event|Part A SAD: VIR-2218 100 mg|"Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389508|NCT03672188|EG002|Reported Event|Part A SAD: VIR-2218 200 mg|"Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389509|NCT03672188|EG003|Reported Event|Part A SAD: VIR-2218 400 mg|"Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389510|NCT03672188|EG004|Reported Event|Part A SAD: VIR-2218 600 mg|"Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389511|NCT03672188|EG005|Reported Event|Part A SAD: VIR-2218 900 mg|"Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC~VIR-2218: VIR-2218 given by subcutaneous injection"
11389512|NCT03672188|EG006|Reported Event|Part A SAD: Placebo|"Healthy subjects received a single dose of placebo administered SC~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389513|NCT03672188|EG007|Reported Event|Part B MAD: VIR-2218 20 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
10850936|NCT03410992|FG001|Participant Flow|Bimekizumab 320 mg Q4W|Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11197474|NCT02171195|OG007|Outcome|Group 7 900 mg|BIA 2-093 900mg or placebo
11197475|NCT02171195|OG008|Outcome|Group 8 1200 mg|BIA 2-093 1200mg or placebo
11197476|NCT02171195|EG000|Reported Event|Placebo|Placebo, PLC
11197477|NCT02171195|EG001|Reported Event|Group 1 20 mg|BIA 2-093 20mg or placebo.
11197478|NCT02171195|EG002|Reported Event|Group 2 50 mg|BIA 2-093 50mg or placebo
11197479|NCT02171195|EG003|Reported Event|Group 3 100 mg|BIA 2-093 100mg or placebo
11197480|NCT02171195|EG004|Reported Event|Group 4 200 mg|BIA 2-093 200mg or placebo
11197481|NCT02171195|EG005|Reported Event|Group 5 400 mg|BIA 2-093 or 400mg or placebo
11197482|NCT02171195|EG006|Reported Event|Group 6 600 mg|BIA 2-093 600mg or placebo
11197483|NCT02171195|EG007|Reported Event|Group 7 900 mg|BIA 2-093 900mg or placebo
11197484|NCT02171195|EG008|Reported Event|Group 8 1200 mg|BIA 2-093 1200mg or placebo
11197485|NCT02171234|BG000|Baseline|Placebo|PLC, Placebo
11197486|NCT02171234|BG001|Baseline|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
11197487|NCT02171234|BG002|Baseline|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
11197488|NCT02171234|BG003|Baseline|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
11197489|NCT02171234|BG004|Baseline|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
11197490|NCT02171234|BG005|Baseline|Total|Total of all reporting groups
11197491|NCT02171234|FG000|Participant Flow|Placebo|PLC, Placebo
11197492|NCT02171234|FG001|Participant Flow|Group 1 - 200 mg b.i.d.|BIA 2-093 200mg (twice daily)
11197493|NCT02171234|FG002|Participant Flow|Group 2 - 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 400mg
11197494|NCT02171234|FG003|Participant Flow|Group 3 - 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 800mg
11197495|NCT02171234|FG004|Participant Flow|Group 4 - 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 1200mg
11197496|NCT02171234|OG000|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
11197497|NCT02171234|OG001|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
11197498|NCT02171234|OG002|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
11197499|NCT02171234|OG003|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
11197500|NCT02171234|OG004|Outcome|Placebo|PLC, Placebo
11197501|NCT02171234|EG000|Reported Event|Placebo|PLC, Placebo
11197502|NCT02171234|EG001|Reported Event|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
11197503|NCT02171234|EG002|Reported Event|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
11197504|NCT02171234|EG003|Reported Event|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
11197505|NCT02171234|EG004|Reported Event|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
11197506|NCT02171247|BG000|Baseline|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
11197507|NCT02171247|BG001|Baseline|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
11197508|NCT02171247|BG002|Baseline|Total|Total of all reporting groups
11197509|NCT02171247|FG000|Participant Flow|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
11197510|NCT02171247|FG001|Participant Flow|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
11197511|NCT02171247|OG000|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
11389514|NCT03672188|EG008|Reported Event|Part B MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389515|NCT03672188|EG009|Reported Event|Part B MAD: VIR-2218 100 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389516|NCT03672188|EG010|Reported Event|Part B MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389517|NCT03672188|EG011|Reported Event|Part C MAD: VIR-2218 50 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389518|NCT03672188|EG012|Reported Event|Part C MAD: VIR-2218 200 mg|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.~VIR-2218: VIR-2218 given by subcutaneous injection"
11389519|NCT03672188|EG013|Reported Event|Part B MAD: Placebo|"Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389520|NCT03672188|EG014|Reported Event|Part C MAD: Placebo|"Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.~Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection"
11389521|NCT03637959|BG000|Baseline|Mechanical Vibrations With Ultrasound Shear Wave Imaging|"Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness~Mechanical Vibrations with Ultrasound Shear Wave Imaging: Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination."
11389522|NCT03637959|FG000|Participant Flow|Mechanical Vibrations With Ultrasound Shear Wave Imaging|"Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness~Mechanical Vibrations with Ultrasound Shear Wave Imaging: Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination."
11389523|NCT03637959|OG000|Outcome|Mechanical Vibrations With Ultrasound Shear Wave Imaging|"Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness~Mechanical Vibrations with Ultrasound Shear Wave Imaging: Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination."
11389524|NCT03637959|EG000|Reported Event|Mechanical Vibrations With Ultrasound Shear Wave Imaging|"Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness~Mechanical Vibrations with Ultrasound Shear Wave Imaging: Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination."
11389525|NCT03230916|BG000|Baseline|Cohort 1: IMI/REL 15/7.5 mg/kg|Adolescents (age 12 to <18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
11389526|NCT03230916|BG001|Baseline|Cohort 2: IMI/REL 15/7.5 mg/kg|Older children (6 to <12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
11389527|NCT03230916|BG002|Baseline|Cohort 3: IMI/REL 15/7.5 mg/kg|Younger children (2 to <6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389528|NCT03230916|BG003|Baseline|Cohort 4: IMI/REL 10/5 mg/kg|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389529|NCT03230916|BG004|Baseline|Cohort 4: IMI/REL 15/7.5 mg/kg|Toddlers (1 to <2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389530|NCT03230916|BG005|Baseline|Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
11389531|NCT03230916|BG006|Baseline|Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389532|NCT03230916|BG007|Baseline|Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389533|NCT03230916|BG008|Baseline|Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389534|NCT03230916|BG009|Baseline|Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389535|NCT03230916|BG010|Baseline|Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389536|NCT03230916|BG011|Baseline|Total|Total of all reporting groups
11389537|NCT03230916|FG000|Participant Flow|Cohort 1: IMI/REL 15/7.5 mg/kg|Adolescents (age 12 to <18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
11389538|NCT03230916|FG001|Participant Flow|Cohort 2: IMI/REL 15/7.5 mg/kg|Older children (6 to <12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
11389539|NCT03230916|FG002|Participant Flow|Cohort 3: IMI/REL 15/7.5 mg/kg|Younger children (2 to <6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389540|NCT03230916|FG003|Participant Flow|Cohort 4: IMI/REL 10/5 mg/kg|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11197512|NCT02171247|OG001|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
11197513|NCT02171247|EG000|Reported Event|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
11389541|NCT03230916|FG004|Participant Flow|Cohort 4: IMI/REL 15/7.5 mg/kg|Toddlers (1 to <2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389542|NCT03230916|FG005|Participant Flow|Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
11389543|NCT03230916|FG006|Participant Flow|Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389544|NCT03230916|FG007|Participant Flow|Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389545|NCT03230916|FG008|Participant Flow|Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389546|NCT03230916|FG009|Participant Flow|Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389547|NCT03230916|FG010|Participant Flow|Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389548|NCT03230916|OG000|Outcome|Cohort 1: IMI/REL 500/250 mg 30-minute Infusion|Adolescents (age 12 to <18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
11389549|NCT03230916|OG001|Outcome|Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion|Older children (6 to <12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389550|NCT03230916|OG002|Outcome|Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion|Older children (6 to <12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389551|NCT03230916|OG003|Outcome|Cohort 2: IMI/REL 500/250 mg 30-minute Infusion|Older children (6 to <12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
11389552|NCT03230916|OG004|Outcome|Cohort 2: IMI/REL 500/250 mg 60-minute Infusion|Older children (6 to <12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
11389553|NCT03230916|OG005|Outcome|Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion|Younger children (2 to <6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389554|NCT03230916|OG006|Outcome|Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion|Younger children (2 to <6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389555|NCT03230916|OG007|Outcome|Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389556|NCT03230916|OG008|Outcome|Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion|Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389557|NCT03230916|OG009|Outcome|Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion|Neonates to infants (birth to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389558|NCT03230916|OG010|Outcome|Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion|Neonates to infants (birth to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389559|NCT03230916|OG010|Outcome|Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion|Neonates to Infants (birth to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389560|NCT03230916|OG000|Outcome|Cohort 1: IMI/REL 500-250 mg 30-minute Infusion|Cohort 1: IMI/REL 500/250 mg 30-minute infusion Adolescents (age 12 to <18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
11389561|NCT03230916|OG007|Outcome|Cohort 4: IMI/REL 10/5 mg/kg|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389562|NCT03230916|OG008|Outcome|Cohort 4: IMI/REL 15/7.5 mg/kg|Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389563|NCT03230916|OG009|Outcome|Cohort 5: IMI/REL 10/5 mg/kg|Neonates to infants (birth to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389564|NCT03230916|OG010|Outcome|Cohort 5: IMI/REL 15/7.5 mg/kg|Neonates to infants (birth to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389565|NCT03230916|OG000|Outcome|Cohort 1: IMI/REL 15/7.5 mg/kg|Adolescents (age 12 to <18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
11389566|NCT03230916|OG001|Outcome|Cohort 2: IMI/REL 15/7.5 mg/kg|Older children (6 to <12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
11389567|NCT03230916|OG002|Outcome|Cohort 3: IMI/REL 15/7.5 mg/kg|Younger children (2 to <6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389568|NCT03230916|OG003|Outcome|Cohort 4: IMI/REL 10/5 mg/kg|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389569|NCT03230916|OG004|Outcome|Cohort 4: IMI/REL 15/7.5 mg/kg|Toddlers (1 to <2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389570|NCT03230916|OG005|Outcome|Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
11389571|NCT03230916|OG006|Outcome|Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389572|NCT03230916|OG007|Outcome|Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389573|NCT03230916|OG008|Outcome|Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389574|NCT03230916|OG009|Outcome|Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389575|NCT03230916|OG010|Outcome|Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389576|NCT03230916|EG000|Reported Event|Cohort 1: IMI/REL 15/7.5 mg/kg|Adolescents (age 12 to <18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
11389577|NCT03230916|EG001|Reported Event|Cohort 2: IMI/REL 15/7.5 mg/kg|Older children (6 to <12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
11389578|NCT03230916|EG002|Reported Event|Cohort 3: IMI/REL 15/7.5 mg/kg|Younger children (2 to <6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389579|NCT03230916|EG003|Reported Event|Cohort 4: IMI/REL 10/5 mg/kg|Infants (3 months to <1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389580|NCT03230916|EG004|Reported Event|Cohort 4: IMI/REL 15/7.5 mg/kg|Toddlers (1 to <2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389581|NCT03230916|EG005|Reported Event|Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
11389582|NCT03230916|EG006|Reported Event|Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389583|NCT03230916|EG007|Reported Event|Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
11389584|NCT03230916|EG008|Reported Event|Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg|Young infants (4 weeks to <3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389585|NCT03230916|EG009|Reported Event|Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg|Older neonates (1 to <4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389586|NCT03230916|EG010|Reported Event|Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg|Younger neonates (<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
11389587|NCT03195894|BG000|Baseline|Conventional Treatment and TripleA|Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA.
11389588|NCT03195894|BG001|Baseline|Conventional Treatment|Conventional treatment which is medication or a 12-step addiction treatment according to the Minnesota model.
11389589|NCT03195894|BG002|Baseline|Total|Total of all reporting groups
11389590|NCT03195894|FG000|Participant Flow|Conventional Treatment and TripleA|Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver
11389591|NCT03195894|FG001|Participant Flow|Conventional Treatment|Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.
11389592|NCT03195894|OG000|Outcome|Conventional Treatment and TripleA|"Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver~TripleA"
11389593|NCT03195894|OG001|Outcome|Conventional Treatment|Conventional treatment only.
11389594|NCT03195894|OG000|Outcome|Conventional Treatment and TripleA|Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver
11389595|NCT03195894|OG001|Outcome|Conventional Treatment|Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.
11389596|NCT03195894|OG001|Outcome|Conventional Treatment|Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment
11389597|NCT03195894|EG000|Reported Event|Conventional Treatment and TripleA|Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver
11389598|NCT03195894|EG001|Reported Event|Conventional Treatment|Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment
11389599|NCT03032705|BG000|Baseline|SonicFill™ 2|"Composite: SonicFill™ 2; Bonding Agent: Optibond XRT~SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer."
11389600|NCT03032705|BG001|Baseline|Filtek™ Supreme|"Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive~Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class."
11389601|NCT03032705|BG002|Baseline|Total|Total of all reporting groups
11389602|NCT03032705|FG000|Participant Flow|SonicFill™ 2|"Composite: SonicFill™ 2; Bonding Agent: Optibond XRT~SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer."
11389603|NCT03032705|FG001|Participant Flow|Filtek™ Supreme|"Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive~Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class."
11389604|NCT03032705|OG000|Outcome|SonicFill™ 2|"Composite: SonicFill™ 2; Bonding Agent: Optibond XRT~SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer."
10803604|NCT03093480|BG000|Baseline|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
10965847|NCT00884286|FG001|Participant Flow|Aplidin®(Other Lymphoma)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389605|NCT03032705|OG001|Outcome|Filtek™ Supreme|"Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive~Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class."
11389606|NCT03032705|EG000|Reported Event|SonicFill™ 2|"Composite: SonicFill™ 2; Bonding Agent: Optibond XRT~SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer."
11389607|NCT03032705|EG001|Reported Event|Filtek™ Supreme|"Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive~Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class."
11389608|NCT02573259|BG000|Baseline|Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])|Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
11389609|NCT02573259|BG001|Baseline|Part 1: PF-06801591 1 mg/kg (IV)|Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
11389610|NCT02573259|BG002|Baseline|Part 1: PF-06801591 3 mg/kg (IV)|Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
11389611|NCT02573259|BG003|Baseline|Part 1: PF-06801591 10 mg/kg (IV)|Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
11389612|NCT02573259|BG004|Baseline|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389613|NCT02573259|BG005|Baseline|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389614|NCT02573259|BG006|Baseline|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389615|NCT02573259|BG007|Baseline|Total|Total of all reporting groups
11389616|NCT02573259|FG000|Participant Flow|Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])|Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
11389617|NCT02573259|FG001|Participant Flow|Part 1: PF-06801591 1 mg/kg (IV)|Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
11389618|NCT02573259|FG002|Participant Flow|Part 1: PF-06801591 3 mg/kg (IV)|Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
11389619|NCT02573259|FG003|Participant Flow|Part 1: PF-06801591 10 mg/kg (IV)|Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
11389620|NCT02573259|FG004|Participant Flow|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389621|NCT02573259|FG005|Participant Flow|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389622|NCT02573259|FG006|Participant Flow|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389623|NCT02573259|OG000|Outcome|Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])|Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
11389624|NCT02573259|OG001|Outcome|Part 1: PF-06801591 1 mg/kg (IV)|Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
11389625|NCT02573259|OG002|Outcome|Part 1: PF-06801591 3 mg/kg (IV)|Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
11389626|NCT02573259|OG003|Outcome|Part 1: PF-06801591 10 mg/kg (IV)|Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
11389627|NCT02573259|OG004|Outcome|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389628|NCT02573259|OG005|Outcome|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389629|NCT02573259|OG006|Outcome|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389630|NCT02573259|OG000|Outcome|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389631|NCT02573259|OG001|Outcome|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389632|NCT02573259|OG000|Outcome|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389633|NCT02573259|OG001|Outcome|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389634|NCT02573259|OG002|Outcome|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389635|NCT02573259|OG003|Outcome|Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])|Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
11389636|NCT02573259|OG004|Outcome|Part 1: PF-06801591 1 mg/kg (IV)|Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
11389637|NCT02573259|OG005|Outcome|Part 1: PF-06801591 3 mg/kg (IV)|Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
11389638|NCT02573259|OG006|Outcome|Part 1: PF-06801591 10 mg/kg (IV)|Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
11389639|NCT02573259|OG000|Outcome|Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])|This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).
11389640|NCT02573259|OG001|Outcome|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389641|NCT02573259|OG002|Outcome|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389642|NCT02573259|OG003|Outcome|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
10850937|NCT03410992|FG002|Participant Flow|Placebo/Placebo|Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.
11389643|NCT02573259|EG000|Reported Event|Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])|Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
11389644|NCT02573259|EG001|Reported Event|Part 1: PF-06801591 1 mg/kg (IV)|Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
11389645|NCT02573259|EG002|Reported Event|Part 1: PF-06801591 3 mg/kg (IV)|Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
11389646|NCT02573259|EG003|Reported Event|Part 1: PF-06801591 10 mg/kg (IV)|Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
11389647|NCT02573259|EG004|Reported Event|Part 1: PF-06801591 300 mg (Subcutaneously [SC])|Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
11389648|NCT02573259|EG005|Reported Event|Part 1: PF-06801591 IV Total|Participants received PF-06801591 IV every 3 weeks for 21-day cycles in Part 1. (up to a maximum of of 233 weeks)
11389649|NCT02573259|EG006|Reported Event|Part 1: PF-06801591 IV and SC Total|Participants received PF-06801591 IV every 3 weeks for 21-day cycles or SC every 4 weeks for 28-day cycles in Part 1. (up to a maximum of 233 weeks)
11389650|NCT02573259|EG007|Reported Event|Part 2: PF-06801591 300 mg (SC) for NSCLC|Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
11389651|NCT02573259|EG008|Reported Event|Part 2: PF-06801591 300 mg (SC) for UC|Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
11389652|NCT02573259|EG009|Reported Event|Part 2: PF-06801591 NSCLC and UC Total|Participants with NSCLC or UC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles in Part 2. (up to a maximum of 126 weeks)
11389653|NCT02318329|BG000|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg|3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389654|NCT02318329|BG001|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg|3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389655|NCT02318329|BG002|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg|3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles..
11389656|NCT02318329|BG003|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg|3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389657|NCT02318329|BG004|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg|3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389658|NCT02318329|BG005|Baseline|Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg|3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389659|NCT02318329|BG006|Baseline|Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
11389660|NCT02318329|BG007|Baseline|Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
11389661|NCT02318329|BG008|Baseline|Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles.
11389662|NCT02318329|BG009|Baseline|Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389663|NCT02318329|BG010|Baseline|Total|Total of all reporting groups
11389664|NCT02318329|FG000|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg|3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389665|NCT02318329|FG001|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg|A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 1.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389666|NCT02318329|FG002|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg|A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 3.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389667|NCT02318329|FG003|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg|A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389668|NCT02318329|FG004|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg|A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389669|NCT02318329|FG005|Participant Flow|Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg|A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 15 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389670|NCT02318329|FG006|Participant Flow|Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
11389671|NCT02318329|FG007|Participant Flow|Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg|Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389672|NCT02318329|FG008|Participant Flow|Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg|Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.
11389673|NCT02318329|FG009|Participant Flow|Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389674|NCT02318329|OG000|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg|3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389675|NCT02318329|OG001|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg|3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389676|NCT02318329|OG002|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg|3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389677|NCT02318329|OG003|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg|3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389678|NCT02318329|OG004|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg|3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389679|NCT02318329|OG005|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg|3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389680|NCT02318329|OG006|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
11197514|NCT02171247|EG001|Reported Event|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
11389681|NCT02318329|OG007|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
11389682|NCT02318329|OG008|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
11389683|NCT02318329|OG000|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles..
11389684|NCT02318329|OG001|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
11389685|NCT02318329|OG002|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
11389686|NCT02318329|OG003|Outcome|Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389687|NCT02318329|OG000|Outcome|Phase 1a Dose Escalation 0.3 mg/kg|3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389688|NCT02318329|OG001|Outcome|Phase 1a Dose Escalation 1 mg/kg|3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389689|NCT02318329|OG002|Outcome|Phase 1a Dose Escalation 3 mg/kg|3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389690|NCT02318329|OG003|Outcome|Phase 1a Dose Escalation 6 mg/kg|3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389691|NCT02318329|OG004|Outcome|Phase 1a Dose Escalation 10 mg/kg|3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389692|NCT02318329|OG005|Outcome|Phase 1a Dose Escalation 15 mg/kg|3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389693|NCT02318329|OG006|Outcome|Phase 1b Dose Escalation in Gastric Cancer 3 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
11389694|NCT02318329|OG007|Outcome|Phase 1b Dose Escalation in Gastric Cancer 6 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
11389695|NCT02318329|OG008|Outcome|Phase 1b Dose Escalation in Gastric Cancer 10 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
11389696|NCT02318329|OG009|Outcome|Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389697|NCT02318329|OG001|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg|3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389698|NCT02318329|OG002|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg|3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389699|NCT02318329|OG003|Outcome|Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg|3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389700|NCT02318329|OG007|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 6mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
11389701|NCT02318329|OG008|Outcome|Part 1B: FPA144 Dose Escalation Gastric Cancer 10mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
11389702|NCT02318329|OG000|Outcome|Part 1/2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389703|NCT02318329|EG000|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg|3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389704|NCT02318329|EG001|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg|3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389705|NCT02318329|EG002|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg|3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389706|NCT02318329|EG003|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg|3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389707|NCT02318329|EG004|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg|3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389708|NCT02318329|EG005|Reported Event|Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg|3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles.
11389709|NCT02318329|EG006|Reported Event|Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles
11389710|NCT02318329|EG007|Reported Event|Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles
11389711|NCT02318329|EG008|Reported Event|Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg|3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles
11389712|NCT02318329|EG009|Reported Event|Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors|Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
11389713|NCT01602666|BG000|Baseline|Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)|Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
11389714|NCT01602666|BG001|Baseline|Stratum 2 Localized Germinoma|Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
11389715|NCT01602666|BG002|Baseline|Total|Total of all reporting groups
11389716|NCT01602666|FG000|Participant Flow|Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)|Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
11389717|NCT01602666|FG001|Participant Flow|Stratum 2 Localized Germinoma|Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
11389718|NCT01602666|OG000|Outcome|Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)|Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
11389719|NCT01602666|OG000|Outcome|Stratum 2 Localized Germinoma|Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
11389720|NCT01602666|OG000|Outcome|hCGbeta <= 50 mIU/mL|CSF/serum hCGbeta <= 50 mIU/mL
11389721|NCT01602666|OG001|Outcome|50 mIU/mL < hCGbeta <= 100 mIU/mL|50 mIU/mL < CSF /serum hCGbeta <= 100 mIU/mL
11389722|NCT01602666|EG000|Reported Event|Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)|Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
11389723|NCT01602666|EG001|Reported Event|Stratum 2 Localized Germinoma|Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
11389724|NCT01375959|BG000|Baseline|Resveratrol First|"resveratrol 500 mg capsules, 3 each day for 6 weeks~resveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks"
11389725|NCT01375959|BG001|Baseline|Placebo First|"matching placebo capsule containing lactose, 3 each day for 6 weeks~Placebo: 3 placebo capsules orally twice a day for 6 weeks"
11389726|NCT01375959|BG002|Baseline|Total|Total of all reporting groups
11389727|NCT01375959|FG000|Participant Flow|Resveratrol First, Then Placebo|"resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks~wash-out period for 2 weeks~matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks"
11389728|NCT01375959|FG001|Participant Flow|Placebo First, Then Resveratrol|"matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks~wash-out period for 2 weeks~resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks"
11389729|NCT01375959|OG000|Outcome|Resveratrol|Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.
11389730|NCT01375959|OG001|Outcome|Placebo|Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.
11389731|NCT01375959|EG000|Reported Event|Resveratrol|resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
11389732|NCT01375959|EG001|Reported Event|Placebo|matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks
11389733|NCT01224106|BG000|Baseline|Placebo (Parts 1 and 2)|Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389734|NCT01224106|BG001|Baseline|Gantenerumab 105 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389735|NCT01224106|BG002|Baseline|Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389736|NCT01224106|BG003|Baseline|Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389737|NCT01224106|BG004|Baseline|Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389738|NCT01224106|BG005|Baseline|Total|Total of all reporting groups
11389739|NCT01224106|FG000|Participant Flow|Placebo (Parts 1 and 2)|Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389740|NCT01224106|FG001|Participant Flow|Gantenerumab 105 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389741|NCT01224106|FG002|Participant Flow|Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389742|NCT01224106|FG003|Participant Flow|Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389743|NCT01224106|FG004|Participant Flow|Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389744|NCT01224106|OG000|Outcome|Placebo (Parts 1 and 2)|Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389745|NCT01224106|OG001|Outcome|Gantenerumab 105 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389746|NCT01224106|OG002|Outcome|Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389747|NCT01224106|OG000|Outcome|Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389748|NCT01224106|OG001|Outcome|Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389749|NCT01224106|OG003|Outcome|Placebo Match Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received matching Placebo to Gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389750|NCT01224106|OG000|Outcome|Placebo (Parts 1 and 2)|Participants with Alzheimer's disease received Placebo SC injection (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389751|NCT01224106|OG000|Outcome|Gantenerumab 105 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389752|NCT01224106|OG001|Outcome|Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389753|NCT01224106|OG000|Outcome|Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389754|NCT01224106|OG000|Outcome|Gantenerumab 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at a dose of 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389755|NCT01224106|EG000|Reported Event|Placebo (Parts 1 and 2)|Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389756|NCT01224106|EG001|Reported Event|Gantenerumab 105 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389757|NCT01224106|EG002|Reported Event|Gantenerumab 225 mg (Parts 1 and 2)|Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
11389758|NCT01224106|EG003|Reported Event|Placebo (Parts 1 and 2) Switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389759|NCT01224106|EG004|Reported Event|Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])|Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
11389760|NCT00999609|BG000|Baseline|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
11389761|NCT00999609|BG001|Baseline|Control|Control group did not receive voretigene neparvovec-rzyl. The control group became eligible to receive voretigene neparvovec-rzyl 1 year after their baseline evaluations, provided they still met all eligibility criteria.
11389762|NCT00999609|BG002|Baseline|Total|Total of all reporting groups
11389763|NCT00999609|FG000|Participant Flow|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
11389764|NCT00999609|FG001|Participant Flow|Control|No intervention, no sham; uninjected control group
11389765|NCT00999609|OG000|Outcome|Intervention|Bilateral, subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2)
11389766|NCT00999609|OG001|Outcome|Control|No intervention, no sham; uninjected control group
11389767|NCT00999609|EG000|Reported Event|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
11389768|NCT00999609|EG001|Reported Event|Control|No intervention, no sham; uninjected control group
11389769|NCT00354835|BG000|Baseline|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389770|NCT00354835|BG001|Baseline|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389771|NCT00354835|BG002|Baseline|Total|Total of all reporting groups
11389772|NCT00354835|FG000|Participant Flow|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
11389773|NCT00354835|FG001|Participant Flow|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389774|NCT00354835|OG000|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
11389775|NCT00354835|OG001|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389776|NCT00354835|OG000|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389777|NCT00354835|OG000|Outcome|VAC (Weeks 1-15)|Reporting period 1 (acute)
11389778|NCT00354835|OG001|Outcome|VAC (Weeks 31 - 43)|Reporting period 3 (late)
10965848|NCT00884286|OG000|Outcome|Arm One|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389779|NCT00354835|OG000|Outcome|% Change in SUVmax From Baseline to Week 4 < 40%|
11389780|NCT00354835|OG001|Outcome|% Change in SUVmax From Baseline to Week 4 >= 40%|
10965849|NCT00884286|OG000|Outcome|Arm One (Non-cutaneous PTCL Cohort)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389781|NCT00354835|OG000|Outcome|% Change in SUVmax From Baseline to Week 15 < 40%|
11389782|NCT00354835|OG001|Outcome|% Change in SUVmax From Baseline to Week 15 >= 40%|
11389783|NCT00354835|OG000|Outcome|UGT1A1 Genotype 6/6|
11389784|NCT00354835|OG001|Outcome|UGT1A1 Genotype 6/7|
11389785|NCT00354835|OG002|Outcome|UGT1A1 Genotype 7/7|
11389786|NCT00354835|OG000|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389787|NCT00354835|OG000|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|
11389788|NCT00354835|OG000|Outcome|PAX3|Fusion positive with PAX3 partner
11389789|NCT00354835|OG001|Outcome|PAX7|Fusion positive with PAX7 partner
11389790|NCT00354835|OG001|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
11389791|NCT00354835|EG000|Reported Event|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11389792|NCT00354835|EG001|Reported Event|VAC Alternating With VI|"Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Irinotecan Hydrochloride: Given IV~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11389793|NCT04531241|BG000|Baseline|Dispensed Subjects|All subjects dispensed a study lens.
11389794|NCT04531241|FG000|Participant Flow|Senofilcon A (Test)/ Senofilcon A (Control)|subjects that wore the senofilcon A (Test) lens in period 1 and the senofilcon A (Control) in period 2.
11389795|NCT04531241|FG001|Participant Flow|Senofilcon A (Control)/ Senofilcon A (Test)|subjects that wore the senofilcon A (Control) lens in period 1 and the senofilcon A (Test) in period 2.
11389796|NCT04531241|OG000|Outcome|Senofilcon A (Test)|Subjects that wore the Test lens in either the first or second period of the study.
11389797|NCT04531241|OG001|Outcome|Senofilcon A (Control)|Subjects that wore the Control lens in either the first or second period of the study.
11389798|NCT04531241|EG000|Reported Event|Senofilcon A (Test)|Subjects that wore the Test lens in either the first or second period of the study.
11389799|NCT04531241|EG001|Reported Event|Senofilcon A (Control)|Subjects that wore the Control lens in either the first or second period of the study.
11389800|NCT04456153|BG000|Baseline|Standard of Care Therapy With Atovaquone|The first treatment group will receive continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days.
11389801|NCT04456153|BG001|Baseline|Standard of Care Therapy With Matching Placebo|The second treatment group will receive continued standard of care therapy together with matching placebo.
11389802|NCT04456153|BG002|Baseline|Total|Total of all reporting groups
11389803|NCT04456153|FG000|Participant Flow|Standard of Care Therapy With Matching Placebo|"The second treatment group will receive continued standard of care therapy together with matching placebo.~Placebo Group: Continued standard of care therapy together with matching placebo"
11389804|NCT04456153|FG001|Participant Flow|Standard of Care Therapy With Atovaquone|"The first treatment group will receive continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days.~Experimental Group: Continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days"
11389805|NCT04456153|OG000|Outcome|Overall Group|Comparison of experimental group to placebo
11389806|NCT04456153|OG001|Outcome|Atovaquone Group With Standard of Care Treatment|This arm received atovaquone 2: 1 in addition to the standard of care.
11389807|NCT04456153|OG002|Outcome|Placebo Plus Standard of Care|This arm received matched placebo in addition to the standard of care.
11389808|NCT04456153|OG000|Outcome|Difference Between Atovaquone and Placebo|Comparison of experimental group to placebo
11389809|NCT04456153|OG001|Outcome|Atovaquone Plus Standard of Care|Log 10 viral load of atovaquone group at Day 3, 5, 7
11389810|NCT04456153|OG002|Outcome|Placebo Plus Standard of Care|Log 10 viral load of placebo group at Day 3, 5, and 7
11389811|NCT04456153|OG000|Outcome|Stratified by Sex: Men|Comparison of change in viral load from Day 1 to day 10 between placebo and atovaquone
11389812|NCT04456153|OG001|Outcome|Stratified by Sex: Women|Comparison of change in viral load from Day 1 to day 10 between placebo and atovaquone
11389813|NCT04456153|OG000|Outcome|Atovaquone|Atovaquone plus standard of care therapy. Proportion who had 2 log drop at Day 3
11389814|NCT04456153|OG001|Outcome|Placebo|Matching placebo plus standard of care therapy. Proportion who had 2 log drop at Day 3
11389815|NCT04456153|OG000|Outcome|Atovaquone|Atovaquone group at Day 15. Number of participants who had > or = 2 point change in ordinal score
11389816|NCT04456153|OG001|Outcome|Placebo|Matching placebo at Day 15. Number of participants who had > or = 2 point change in ordinal score
11389817|NCT04456153|OG000|Outcome|Atovaquone|Atovaquone plus standard of care
11389818|NCT04456153|OG001|Outcome|Placebo|Matching placebo plus standard of care
11389819|NCT04456153|OG000|Outcome|Stratified With Remdesivir|Participants who received remdesivir as part of standard of care
11389820|NCT04456153|OG001|Outcome|Stratified Without Remdesivir|Participants who did not receive remdesivir as part of standard of care
11389821|NCT04456153|EG000|Reported Event|Atovaquone|Atovaquone plus standard of care. Grade 3 and 4 adverse events were collected.
11389822|NCT04456153|EG001|Reported Event|Placebo|Matching placebo plus standard of care
11389823|NCT04351243|BG000|Baseline|Gimsilumab|"Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8~Gimsilumab: Gimsilumab is a fully human monoclonal antibody (mAb)."
11389824|NCT04351243|BG001|Baseline|Placebo|"Normal saline on Day 1 Normal saline on Day 8~Placebo: Normal saline"
11389825|NCT04351243|BG002|Baseline|Total|Total of all reporting groups
11389826|NCT04351243|FG000|Participant Flow|Gimsilumab|"Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8~Gimsilumab: Gimsilumab is a fully human monoclonal antibody (mAb)."
11389827|NCT04351243|FG001|Participant Flow|Placebo|"Normal saline on Day 1 Normal saline on Day 8~Placebo: Normal saline"
11389828|NCT04351243|OG000|Outcome|Gimsilumab|Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
11389829|NCT04351243|OG001|Outcome|Placebo|Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
11389830|NCT04351243|EG000|Reported Event|Gimsilumab|Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
11389831|NCT04351243|EG001|Reported Event|Placebo|Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
11389832|NCT04312256|BG000|Baseline|Dominant Hand and Great Toe|"Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes."
11389833|NCT04312256|FG000|Participant Flow|Dominant Hand and Great Toe|"Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes."
11389834|NCT04312256|OG000|Outcome|Flexor Hallucis Brevis (Great Toe)|TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.
11389835|NCT04312256|OG001|Outcome|Adductor Pollicis (Thumb)|TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.
11389836|NCT04312256|EG000|Reported Event|Dominant Hand and Great Toe|"Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes."
11197515|NCT02171260|BG000|Baseline|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
10965850|NCT00884286|OG001|Outcome|Arm One (Subset of Treated Patients With Other Lymphomas)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11197516|NCT02171260|BG001|Baseline|Part A1: Eribulin Mesylate 1.4 mg/m^2|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197517|NCT02171260|BG002|Baseline|Part A1: Eribulin Mesylate 1.8 mg/m^2|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11389837|NCT04185220|BG000|Baseline|Dose Level 1 (Interleukin-15 2mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389838|NCT04185220|BG001|Baseline|Dose Level 2 (Interleukin-15 4mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389839|NCT04185220|BG002|Baseline|Total|Total of all reporting groups
11389840|NCT04185220|FG000|Participant Flow|Dose Level 1 (Interleukin-15 2mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389841|NCT04185220|FG001|Participant Flow|Dose Level 2 (Interleukin-15 4mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389842|NCT04185220|OG000|Outcome|All Participants|All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389843|NCT04185220|OG000|Outcome|Dose Level 1 (Interleukin-15 2mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389844|NCT04185220|OG001|Outcome|Dose Level 2 (Interleukin-15 4mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389845|NCT04185220|EG000|Reported Event|Dose Level 1 (Interleukin-15 2mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389846|NCT04185220|EG001|Reported Event|Dose Level 2 (Interleukin-15 4mcg/kg/Day)|Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
11389847|NCT03851107|BG000|Baseline|Community-based Activity Program|A 22-week individual-based interrupted time series design with multiple baselines was used (Clinical Trials identifier NCT03851107). The time-point in which the intervention, that is engagement in a chosen 8-week activity, was introduced varied. This resulted in different lengths of baselines, of 6 to 11 weeks, across participants.
11389848|NCT03851107|FG000|Participant Flow|Community-based Activity Program|"Engagement in 8-week community-based activity program~Engagement in 8-week community-based activity program: Participants engage in a 8-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 8 weeks - the actual intervention phase."
11389849|NCT03851107|OG000|Outcome|Change in Behavioural Assessment System for Children|Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
11389850|NCT03851107|OG000|Outcome|Change in Range of Motion Measure|Range of Motion was measured repeatedly (biweekly for up to 22 weeks) throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-point, 4 wks).
11389851|NCT03851107|OG000|Outcome|Change in Trunk Impairment Scale|Trunk Impairment Scale was measured repeatedly (biweekly for up to 22 weeks) throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-point, 4 wks).
11389852|NCT03851107|OG000|Outcome|Change in Functional Reach Test|Functional Reach Test was measured repeatedly (biweekly for up to 22 weeks) throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-point, 4 wks).
11389853|NCT03851107|OG000|Outcome|Change in Jamar Dynamometer Strength Test|Jamar dynamometer strength test was measured repeatedly (biweekly for up to 22 weeks) throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-point, 4 wks).
11389854|NCT03851107|OG000|Outcome|Change in Canadian Occupational Performance Measure|Canadian Occupational Performance Measure was assessed repeatedly (weekly) throughout the phases of the study over a period of 18-weeks: baseline (11 time-points; 8 wks) intervention (8 time-points; 6 wks) and follow-up (2-points, 4 wks) resulting in a total of 22 data-points.
10850938|NCT03410992|FG003|Participant Flow|Bimekizumab 320 mg Q4W/Placebo|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.
11389855|NCT03851107|OG000|Outcome|Change in Motor Outcomes|Changes in outcomes of range of motion (ROM), trunk impairment scale (TIS), functional reach test and Jamar dynamometer strength test were measured repeatedly (biweekly for up to 22 weeks) throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-point, 4 wks).
11389856|NCT03851107|EG000|Reported Event|Community-based Activity Program|"Engagement in 6-week community-based activity program~Engagement in 6-week community-based activity program: Participants engage in a 6-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 6 weeks - the actual intervention phase."
11389857|NCT03600714|BG000|Baseline|Treatment|Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
11389858|NCT03600714|FG000|Participant Flow|Treatment|Patients were treated with lonafarnib 50 mg orally twice daily, ritonavir 100 mg orally twice daily and lambda 180 mcg subcutaneously weekly for 24 weeks
11389859|NCT03600714|OG000|Outcome|Treatment|Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
11389860|NCT03600714|EG000|Reported Event|Treatment|Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
11389861|NCT03479307|BG000|Baseline|Bilastine Ophthalmic Solution 0.6%|Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
11389862|NCT03479307|BG001|Baseline|Ketotifen Ophthalmic Solution 0.025% (Zaditen)|Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
11389863|NCT03479307|BG002|Baseline|Vehicle of Bilastine Ophthalmic Solution|Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
11389864|NCT03479307|BG003|Baseline|Total|Total of all reporting groups
11197518|NCT02171260|BG003|Baseline|Part A1: Eribulin Mesylate PK Expansion|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
11389865|NCT03479307|FG000|Participant Flow|Bilastine Ophthalmic Solution 0.6%|Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
11389866|NCT03479307|FG001|Participant Flow|Ketotifen Ophthalmic Solution 0.025% (Zaditen)|Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
11389867|NCT03479307|FG002|Participant Flow|Vehicle of Bilastine Ophthalmic Solution|Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
11389868|NCT03479307|OG000|Outcome|Bilastine Ophthalmic Solution 0.6%|Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
11389869|NCT03479307|OG001|Outcome|Ketotifen Ophthalmic Solution 0.025% (Zaditen)|Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
11389870|NCT03479307|OG002|Outcome|Vehicle of Bilastine Ophthalmic Solution|Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
11389871|NCT03479307|EG000|Reported Event|Bilastine Ophthalmic Solution 0.6%|Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
11389872|NCT03479307|EG001|Reported Event|Ketotifen Ophthalmic Solution 0.025% (Zaditen)|Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
11389873|NCT03479307|EG002|Reported Event|Vehicle of Bilastine Ophthalmic Solution|Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
11389874|NCT03470441|BG000|Baseline|Experimental FDY-5301 Low Dose|0.5 mg/kg FDY-5301
11389875|NCT03470441|BG001|Baseline|Experimental FDY-5301 Intermediate Dose|1.0 mg/kg FDY-5301
11197519|NCT02171260|BG004|Baseline|Total|Total of all reporting groups
11197520|NCT02171260|FG000|Participant Flow|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate (E7389) 1.1 milligram per square meter (mg/m^2), intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until progressive disease (PD) or unacceptable toxicity or drug related dose-limiting toxicities (DLT's).
11197521|NCT02171260|FG001|Participant Flow|Part A1: Eribulin Mesylate 1.4 mg/m^2|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11389876|NCT03470441|BG002|Baseline|Experimental FDY-5301 High Dose|2.0 mg/kg FDY-5301
11389877|NCT03470441|BG003|Baseline|Placebo|Placebo
11389878|NCT03470441|BG004|Baseline|Total|Total of all reporting groups
11389879|NCT03470441|FG000|Participant Flow|Experimental FDY-5301 Low Dose|0.5 mg/kg FDY-5301
11389880|NCT03470441|FG001|Participant Flow|Experimental FDY-5301 Intermediate Dose|1.0 mg/kg FDY-5301
11389881|NCT03470441|FG002|Participant Flow|Experimental FDY-5301 High Dose|2.0 mg/kg FDY-5301
11389882|NCT03470441|FG003|Participant Flow|Placebo|Placebo
11389883|NCT03470441|OG000|Outcome|Experimental FDY-5301 Low Dose|0.5 mg/kg FDY-5301
11389884|NCT03470441|OG001|Outcome|Experimental FDY-5301 Intermediate Dose|1.0 mg/kg FDY-5301
11389885|NCT03470441|OG002|Outcome|Experimental FDY-5301 High Dose|2.0 mg/kg FDY-5301
11389886|NCT03470441|OG003|Outcome|Placebo|Placebo
11389887|NCT03470441|EG000|Reported Event|Experimental FDY-5301 Low Dose|0.5 mg/kg FDY-5301
11389888|NCT03470441|EG001|Reported Event|Experimental FDY-5301 Intermediate Dose|1.0 mg/kg FDY-5301
11389889|NCT03470441|EG002|Reported Event|Experimental FDY-5301 High Dose|2.0 mg/kg FDY-5301
11389890|NCT03470441|EG003|Reported Event|Placebo|Placebo
11389891|NCT03452397|BG000|Baseline|0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL)|0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
11389892|NCT03452397|BG001|Baseline|1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)|1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
11389893|NCT03452397|BG002|Baseline|2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL)|2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
11389894|NCT03452397|BG003|Baseline|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11389895|NCT03452397|BG004|Baseline|Total|Total of all reporting groups
11389896|NCT03452397|FG000|Participant Flow|0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL)|0.2% hemigalactarate (0.11% free base) 0.2% OC-02 Mid Dose (1.1 mg/mL)
11389897|NCT03452397|FG001|Participant Flow|1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL)|"1% hemigalactarate (0.11% free base)~1% OC-02 Mid Dose (5.5 mg/mL)"
11389898|NCT03452397|FG002|Participant Flow|2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL)|2% hemigalactarate (0.11% free base) 2% OC-02 High Dose (11.1 mg/mL)
11389899|NCT03452397|FG003|Participant Flow|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11389900|NCT03452397|OG000|Outcome|0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL)|0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
11389901|NCT03452397|OG001|Outcome|1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)|1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
11389902|NCT03452397|OG002|Outcome|2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL)|2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
11389903|NCT03452397|OG003|Outcome|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11389904|NCT03452397|OG001|Outcome|1 % Hemigalactarate (0.11% Free Base) 1 % OC-02 Mid Dose (5.5 mg/mL)|"1 % hemigalactarate (0.11% free base)~1 % OC-02 Mid Dose (5.5 mg/mL)"
11389905|NCT03452397|OG002|Outcome|2 % Hemigalactarate (0.11% Free Base) 2 % OC-02 High Dose (11.1 mg/mL)|2 % hemigalactarate (0.11% free base) 2 % OC-02 High Dose (11.1 mg/mL)
11389906|NCT03452397|EG000|Reported Event|0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL)|0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
11389907|NCT03452397|EG001|Reported Event|1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)|1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
11389908|NCT03452397|EG002|Reported Event|2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL)|2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
11389909|NCT03452397|EG003|Reported Event|Placebo (Vehicle) Nasal Spray|"Placebo (vehicle) nasal spray~Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray"
11389910|NCT03448939|BG000|Baseline|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11389911|NCT03448939|BG001|Baseline|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
10803936|NCT01049035|OG002|Outcome|Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months|Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
11389912|NCT03448939|BG002|Baseline|Total|Total of all reporting groups
11389913|NCT03448939|FG000|Participant Flow|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11389914|NCT03448939|FG001|Participant Flow|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11389915|NCT03448939|OG000|Outcome|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11389916|NCT03448939|OG001|Outcome|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11389917|NCT03448939|EG000|Reported Event|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11389918|NCT03448939|EG001|Reported Event|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11389919|NCT03410108|BG000|Baseline|Brigatinib 90 mg/180 mg|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 34 cycles till data cut-off date: 29 September 2020.
11389920|NCT03410108|FG000|Participant Flow|Brigatinib 90 mg/180 mg|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed progressive disease (PD) or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 34 cycles till data cut-off date: 29 September 2020.
11389921|NCT03410108|OG000|Outcome|Refractory Expansion Part: Main Cohort|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 31 cycles till data cut-off date: 29 September 2020. Participants who had previously received only alectinib or both alectinib and crizotinib formed a part of the Main Cohort of the Refractory Expansion Part.
11389922|NCT03410108|OG000|Outcome|TKI-Naive Expansion Cohort|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 22 cycles till data cut-off date: 29 September 2020. Participants who had not received any prior TKIs including ALK-TKIs formed a part of the TKI-Naive Expansion Cohort.
11389923|NCT03410108|OG000|Outcome|Brigatinib 90 mg/180 mg|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 34 cycles till data cut-off date: 29 September 2020.
11389924|NCT03410108|OG000|Outcome|Safety Evaluation Lead-in Part|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 34 cycles till data cut-off date: 29 September 2020. Participants with or without prior ALK-TKI treatment formed a part of the Safety Evaluation Lead-in Part.
11389925|NCT03410108|EG000|Reported Event|Brigatinib 90 mg/180 mg|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onwards in 28-day cycles until investigator-assessed PD or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to 34 cycles till data cut-off date: 29 September 2020.
11389926|NCT03377803|BG000|Baseline|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389927|NCT03377803|BG001|Baseline|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo to be applied via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389928|NCT03377803|BG002|Baseline|Total|Total of all reporting groups
11389929|NCT03377803|FG000|Participant Flow|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389930|NCT03377803|FG001|Participant Flow|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo to be applied via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389931|NCT03377803|OG000|Outcome|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389932|NCT03377803|OG001|Outcome|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo to be applied via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389933|NCT03377803|EG000|Reported Event|VP-102|"VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days~VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389934|NCT03377803|EG001|Reported Event|Placebo|"Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days~Placebo: Placebo to be applied via the applicator to Molluscum lesions~Applicator: Used to apply the topical film forming Active or Placebo to Molluscum."
11389935|NCT03283371|BG000|Baseline|Placebo (Placebo-controlled Phase)|Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389936|NCT03283371|BG001|Baseline|Natalizumab 300 mg (Placebo-controlled Phase)|Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389937|NCT03283371|BG002|Baseline|Total|Total of all reporting groups
11389938|NCT03283371|FG000|Participant Flow|Placebo (Placebo-controlled Phase)|Participants received natalizumab-matching placebo intravenous (IV) infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389939|NCT03283371|FG001|Participant Flow|Natalizumab 300 mg (Placebo-controlled Phase)|Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389940|NCT03283371|FG002|Participant Flow|Placebo to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389941|NCT03283371|FG003|Participant Flow|Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389942|NCT03283371|OG000|Outcome|Placebo (Placebo-controlled Phase)|Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389943|NCT03283371|OG001|Outcome|Natalizumab 300 mg (Placebo-controlled Phase)|Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389944|NCT03283371|OG002|Outcome|Placebo to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389945|NCT03283371|OG003|Outcome|Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389946|NCT03283371|EG000|Reported Event|Placebo (Placebo-controlled Phase)|Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389947|NCT03283371|EG001|Reported Event|Natalizumab 300 mg (Placebo- Controlled Phase)|Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24.
11389948|NCT03283371|EG002|Reported Event|Placebo to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab-matching placebo in Placebo-controlled Phase, received natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389949|NCT03283371|EG003|Reported Event|Natalizumab 300 mg to Natalizumab 300 mg (Open-label Phase)|Participants who received natalizumab 300 mg in Placebo-controlled Phase, continued to receive natalizumab 300 mg IV infusion every 4 weeks in Open-label Phase for up to Week 48.
11389950|NCT03257254|BG000|Baseline|Prospective Registry Cohort|Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.
11389951|NCT03257254|FG000|Participant Flow|Prospective Registry Cohort|Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.
11389952|NCT03257254|OG000|Outcome|Prospective Registry Cohort|Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.
11389953|NCT03257254|EG000|Reported Event|Prospective Registry Cohort|Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.
11389954|NCT03084718|BG000|Baseline|Treatment A|CHF 718 pMDI 100 µg TDD
11389955|NCT03084718|BG001|Baseline|Treatment B|CHF 718 pMDI 400 µg TDD
11389956|NCT03084718|BG002|Baseline|Treatment C|CHF 718 pMDI 800 µg TDD
11389957|NCT03084718|BG003|Baseline|Treatment D|Placebo Control
11389958|NCT03084718|BG004|Baseline|Treatment E|"Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR^®), Active Control~Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg;~QVAR® 80 μg/actuation: 2 inhalations BID, Total Daily Dose (TDD) of BDP: 320 μg;"
11389959|NCT03084718|BG005|Baseline|Total|Total of all reporting groups
11389960|NCT03084718|FG000|Participant Flow|Treatment A (CHF 718 pMDI 100 µg TDD)|"CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;~CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); TDD of BDP: 100 μg;"
11389961|NCT03084718|FG001|Participant Flow|Treatment B (CHF 718 pMDI 400 µg TDD)|"CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;~CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; TDD of BDP: 400 μg;"
11389962|NCT03084718|FG002|Participant Flow|Treatment C (CHF 718 pMDI 800 µg TDD)|"CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;~CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; TDD of BDP: 800 μg;"
11389963|NCT03084718|FG003|Participant Flow|Treatment D (Placebo)|Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID);
11389964|NCT03084718|FG004|Participant Flow|Treatment E (QVAR^® 320 µg TDD)|"Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR^®), Active Control~Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID;"
11389965|NCT03084718|OG000|Outcome|Treatment A (CHF 718 pMDI 100 µg TDD)|"CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;~CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);"
11389966|NCT03084718|OG001|Outcome|Treatment B (CHF 718 pMDI 400 µg TDD)|"CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;~CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;"
11389967|NCT03084718|OG002|Outcome|Treatment C (CHF 718 pMDI 800 µg TDD)|"CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;~CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;"
11389968|NCT03084718|OG003|Outcome|Treatment D (Placebo)|Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
11389969|NCT03084718|OG004|Outcome|Treatment E (QVAR^®, 320 µg TDD)|"Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control~Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;"
11389970|NCT03084718|OG000|Outcome|Treatment A (CHF 718 pMDI 100 µg TDD)|"CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;~CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID);"
11389971|NCT03084718|OG003|Outcome|Treatment D (Placebo)|Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID);
11389972|NCT03084718|OG004|Outcome|Treatment E (QVAR^®, 320 µg TDD)|"Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR^®), Active Control~Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR^® 80 μg/actuation: 2 inhalations BID;"
11389973|NCT03084718|EG000|Reported Event|Treatment A (CHF 718 pMDI 100 µg TDD)|"CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;~CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID);"
11389974|NCT03084718|EG001|Reported Event|Treatment B (CHF 718 pMDI 400 µg TDD)|"CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;~CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;"
11389975|NCT03084718|EG002|Reported Event|Treatment C (CHF 718 pMDI 800 µg TDD)|"CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;~CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;"
11389976|NCT03084718|EG003|Reported Event|Treatment D (Placebo)|Placebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID;
11389977|NCT03084718|EG004|Reported Event|Treatment E (QVAR^®, 320 µg TDD)|"QVAR^®, : Active Control~Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg;~QVAR® 80 μg/actuation: 2 inhalations BID;"
11389978|NCT03069417|BG000|Baseline|Intervention: INSPireD|"This 5-8 session group intervention, Integrating Nuanced Support for Perinatal adherence and Depression, aimed to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and CBT for adherence and depression."
11389979|NCT03069417|BG001|Baseline|Control: Treatment-as-usual + Abbreviated Intervention|The control group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study.
11389980|NCT03069417|BG002|Baseline|Total|Total of all reporting groups
11389981|NCT03069417|FG000|Participant Flow|Intervention: INSPireD|"This 5-8 session, group-based intervention, Integrating Nuanced Support for Perinatal Adherence and Depression, had three primary goals: (1) improving adherence to ART during pregnancy and the postpartum period; (2) planning for contraceptive use; and (3) improving depressive symptoms among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and CBT for adherence and depression.The intervention was delivered by a trained lay counselor, who completed a five-day training on counseling skills and intervention content, and received bi-monthly clinical supervision throughout the study."
11389982|NCT03069417|FG001|Participant Flow|Treatment-as-usual + Abbreviated Intervention|The control group received treatment-as usual (standard of care counseling services), plus the option of completing an abbreviated version of the intervention (i.e., one session of problem-solving related to adherence and depression) at the conclusion of study.
11389983|NCT03069417|OG000|Outcome|Intervention: INSPireD|"This 5-8 session group intervention, Integrating Nuanced Support for Perinatal adherence and Depression, aimed to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and Cognitive Behavioral Therapy for Adherence and Depression."
11389984|NCT03069417|OG001|Outcome|Control: Treatment-as-usual + Abbreviated Intervention|The control group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study.
11389985|NCT03069417|OG001|Outcome|Control: Treatment-as-usual + Abbreviated Intervention|The control group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study
11389986|NCT03069417|EG000|Reported Event|Intervention: INSPireD|"This 5-8 session group intervention, Integrating Nuanced Support for Perinatal adherence and Depression, aimed to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and Cognitive Behavioral Therapy for Adherence and Depression."
10965851|NCT00884286|EG000|Reported Event|Aplidin® (Cohort Non-cutaneous PTCL)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
11389987|NCT03069417|EG001|Reported Event|Control: Treatment-as-usual + Abbreviated Intervention|The control group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study.
11389988|NCT03063164|BG000|Baseline|All Participants|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389989|NCT03063164|FG000|Participant Flow|Intralase IFS Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389990|NCT03063164|FG001|Participant Flow|Visumax Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389991|NCT03063164|OG000|Outcome|Intralase IFS Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389992|NCT03063164|OG001|Outcome|Visumax Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389993|NCT03063164|OG000|Outcome|All Participants|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389994|NCT03063164|EG000|Reported Event|Intralase IFS Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389995|NCT03063164|EG001|Reported Event|Visumax Eye|Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
11389996|NCT02952365|BG000|Baseline|Eyes Undergoing LASIK Enhancement|Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
11389997|NCT02952365|FG000|Participant Flow|Eyes Undergoing LASIK Enhancement|Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
11389998|NCT02952365|OG000|Outcome|Eyes Undergoing LASIK Enhancement|Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
11389999|NCT02952365|EG000|Reported Event|Eyes Undergoing LASIK Enhancement|Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth.
11390000|NCT02936323|BG000|Baseline|Phase 1 Dose Escalation (Cohort 1)|Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).
11390001|NCT02936323|BG001|Baseline|Phase 1 Dose Escalation (Cohort 2)|Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).
11390002|NCT02936323|BG002|Baseline|Phase 1 Dose Escalation (Cohort 3)|Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).
11390003|NCT02936323|BG003|Baseline|Phase 1 Dose Escalation (Cohort 4)|Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).
11390004|NCT02936323|BG004|Baseline|Phase 1 Dose Escalation (Cohort 5)|Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).
11390005|NCT02936323|BG005|Baseline|Phase 1 Dose Escalation (Cohort 6)|Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).
11390006|NCT02936323|BG006|Baseline|Phase 1 Dose Escalation (Cohort 7)|Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).
11390007|NCT02936323|BG007|Baseline|Phase 2a Dose Expansion (GI Mid-gut NET Cohort)|"Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET).~Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy [PRRT] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent)."
11390008|NCT02936323|BG008|Baseline|Phase 2a Dose Expansion (PNET Cohort)|Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).
11390009|NCT02936323|BG009|Baseline|Phase 2a Dose Expansion (SCLC Cohort)|Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
11390010|NCT02936323|BG010|Baseline|Total|Total of all reporting groups
11390011|NCT02936323|FG000|Participant Flow|Phase 1 Dose Escalation (Cohort 1)|Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).
11390012|NCT02936323|FG001|Participant Flow|Phase 1 Dose Escalation (Cohort 2)|Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).
11390013|NCT02936323|FG002|Participant Flow|Phase 1 Dose Escalation (Cohort 3)|Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).
11390014|NCT02936323|FG003|Participant Flow|Phase 1 Dose Escalation (Cohort 4)|Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).
11390015|NCT02936323|FG004|Participant Flow|Phase 1 Dose Escalation (Cohort 5)|Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).
11390016|NCT02936323|FG005|Participant Flow|Phase 1 Dose Escalation (Cohort 6)|Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).
11390017|NCT02936323|FG006|Participant Flow|Phase 1 Dose Escalation (Cohort 7)|Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).
11390018|NCT02936323|FG007|Participant Flow|Phase 2a Dose Expansion (GI Mid-gut NET Cohort)|"Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET).~Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy [PRRT] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent)."
11390019|NCT02936323|FG008|Participant Flow|Phase 2a Dose Expansion (PNET Cohort)|Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).
11390020|NCT02936323|FG009|Participant Flow|Phase 2a Dose Expansion (SCLC Cohort)|Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
11390021|NCT02936323|OG000|Outcome|All Participants in Phase 1 Dose Escalation (Cohorts 1-7)|All participants who received at least 1 dose of PEN-221, either at 1.0 mg, 2.0 mg, 4.0 mg, 8.0 mg, 12.0 mg, 18.0 mg, 25.0 mg via IV.
11390022|NCT02936323|OG000|Outcome|Phase 1 Dose Escalation (Cohort 1)|Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg on an every 3-week cycle (21 days +/-2 days).
11390023|NCT02936323|OG001|Outcome|Phase 1 Dose Escalation (Cohort 2)|Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg on an every 3-week cycle (21 days +/-2 days).
11390024|NCT02936323|OG002|Outcome|Phase 1 Dose Escalation (Cohort 3)|Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg on an every 3-week cycle (21 days +/-2 days).
11390025|NCT02936323|OG003|Outcome|Phase 1 Dose Escalation (Cohort 4)|Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg on an every 3-week cycle (21 days +/-2 days).
11390026|NCT02936323|OG004|Outcome|Phase 1 Dose Escalation (Cohort 5)|Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg on an every 3-week cycle (21 days +/-2 days).
11390027|NCT02936323|OG005|Outcome|Phase 1 Dose Escalation (Cohort 6)|Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg on an every 3-week cycle (21 days +/-2 days).
11390028|NCT02936323|OG006|Outcome|Phase 1 Dose Escalation (Cohort 7)|Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg on an every 3-week cycle (21 days +/-2 days).
11390029|NCT02936323|OG000|Outcome|Phase 2a Dose Expansion (GI Mid-gut NET Cohort)|"Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade gastrointestinal mid-gut Neuroendocrine Tumor (GINET).~Participants in the GINET cohort were enrolled into one of two groups which included 25 participants without prior Peptide Receptor Radionuclide Therapy [PRRT] (GINET PRRT Naïve) and 7 participants with prior PRRT (GINET PRRT Recurrent)."
11390030|NCT02936323|OG001|Outcome|Phase 2a Dose Expansion (PNET Cohort|Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).
11390031|NCT02936323|OG000|Outcome|Phase 2a Dose Expansion (SCLC Cohort)|Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
11390032|NCT02936323|OG000|Outcome|Phase 2a Dose Expansion (SCLC Cohort)|Outcome measured by cancer type. SCLC participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment. No participants in the SCLC cohort had an objective response, so no data is presented for this Outcome Measure.
11390033|NCT02936323|OG007|Outcome|Phase 2a Dose Expansion (<8.8 mg/m^2)|"Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)~All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m^2 or > 8.8 mg/m^2 dose groups based on the BSA conversion of the initial study dose."
11390034|NCT02936323|OG008|Outcome|Phase 2a Dose Expansion (8.8 mg/m^2)|Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)
11390035|NCT02936323|OG009|Outcome|Phase 2a Dose Expansion (>8.8 mg/m^2)|"Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)~All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m^2 or > 8.8 mg/m^2 dose groups based on the BSA conversion of the initial study dose."
11390036|NCT02936323|OG000|Outcome|All Phase 2a Dose Expansion Participants|"All GINET, PNET, and SCLC participants who received at least 1 PEN-221 BSA calculated starting dose of either < 8.8 mg/m^2, 8.8 mg/m^2, or > 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)~All non-BSA based doses (flat dose) in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD flat dosing regimen were assigned to the < 8.8 mg/m^2 or > 8.8 mg/m^2 dose groups based on the BSA conversion of the initial study flat dose."
11390037|NCT02936323|OG001|Outcome|Phase 2a Dose Expansion (PNET Cohort)|Participants were enrolled with advanced or metastatic, well-differentiated, low or intermediate grade pancreatic Neuroendocrine Tumor (PNET).
11390038|NCT02936323|OG002|Outcome|Phase 2a Dose Expansion (SCLC Cohort)|Participants were enrolled with advanced or metastatic Small Cell Lung Cancer (SCLC).
11390039|NCT02936323|OG007|Outcome|Phase 2a Dose Expansion (<8.8 mg/m^2)|Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m^2 or > 8.8 mg/m^2 dose groups based on the BSA conversion of the initial study dose.
11390040|NCT02936323|OG009|Outcome|Phase 2a Dose Expansion (>8.8 mg/m^2)|Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days) All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m^2 or > 8.8 mg/m^2 dose groups based on the BSA conversion of the initial study dose.
11390041|NCT02936323|EG000|Reported Event|Phase 1 Dose Escalation (Cohort 1)|Participants in Cohort 1 received PEN-221 administered IV over 1 hour at the starting dose of 1.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390042|NCT02936323|EG001|Reported Event|Phase 1 Dose Escalation (Cohort 2)|Participants in Cohort 2 received PEN-221 administered IV over 1 hour at the starting dose of 2.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390043|NCT02936323|EG002|Reported Event|Phase 1 Dose Escalation (Cohort 3)|Participants in Cohort 3 received PEN-221 administered IV over 1 hour at the starting dose of 4.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390044|NCT02936323|EG003|Reported Event|Phase 1 Dose Escalation (Cohort 4)|Participants in Cohort 4 received PEN-221 administered IV over 1 hour at the starting dose of 8.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390045|NCT02936323|EG004|Reported Event|Phase 1 Dose Escalation (Cohort 5)|Participants in Cohort 5 received PEN-221 administered IV over 1 hour at the starting dose of 12.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390046|NCT02936323|EG005|Reported Event|Phase 1 Dose Escalation (Cohort 6)|Participants in Cohort 6 received PEN-221 administered IV over 1 hour at the starting dose of 18.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390047|NCT02936323|EG006|Reported Event|Phase 1 Dose Escalation (Cohort 7)|Participants in Cohort 7 received PEN-221 administered IV over 1 hour at the starting dose of 25.0 mg1 on an every 3-week cycle (21 days +/-2 days).
11390048|NCT02936323|EG007|Reported Event|Phase 2a Dose Expansion (<8.8 mg/m^2)|"Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of less than 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)~All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m2 or > 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose."
11390049|NCT02936323|EG008|Reported Event|Phase 2a Dose Expansion (8.8 mg/m^2)|Participants in GINET, PNET, and SCLC received PEN-221 BSA starting dose of 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)
11390050|NCT02936323|EG009|Reported Event|Phase 2a Dose Expansion (>8.8 mg/m^2)|"Participants in GINET, PNET, and SCLC received PEN-221 BSA calculated starting dose of more than 8.8 mg/m^2 on an every 3-week cycle (21 days +/-2 days)~All non-BSA based doses in Phase 2a were converted to BSA dosing units. Participants dosed under the initial MTD dosing regimen were assigned to the < 8.8 mg/m2 or > 8.8 mg/m2 dose groups based on the BSA conversion of the initial study dose."
11390051|NCT02631837|BG000|Baseline|vNOTES Hysterectomy|"vaginal Natural Orifice Transluminal Endoscopic Surgery~vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy"
10803937|NCT01049035|OG003|Outcome|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11390052|NCT02631837|BG001|Baseline|LSC Hysterectomy|"Laparoscopic hysterectomy~LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy"
11390053|NCT02631837|BG002|Baseline|Total|Total of all reporting groups
11390054|NCT02631837|FG000|Participant Flow|vNOTES Hysterectomy|"vaginal Natural Orifice Transluminal Endoscopic Surgery~vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy"
11390055|NCT02631837|FG001|Participant Flow|LSC Hysterectomy|"Laparoscopic hysterectomy~LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy"
11390056|NCT02631837|OG000|Outcome|vNOTES Hysterectomy|"vaginal Natural Orifice Transluminal Endoscopic Surgery~vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy"
11390057|NCT02631837|OG001|Outcome|LSC Hysterectomy|"Laparoscopic hysterectomy~LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy"
11390058|NCT02631837|EG000|Reported Event|vNOTES Hysterectomy|"vaginal Natural Orifice Transluminal Endoscopic Surgery~vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy"
11390059|NCT02631837|EG001|Reported Event|LSC Hysterectomy|"Laparoscopic hysterectomy~LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy"
11390060|NCT02437318|BG000|Baseline|Alpelisib qd + Fulvestrant|Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390061|NCT02437318|BG001|Baseline|Placebo qd + Fulvestrant|Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390062|NCT02437318|BG002|Baseline|Total|Total of all reporting groups
11390063|NCT02437318|FG000|Participant Flow|Alpelisib qd + Fulvestrant|Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390064|NCT02437318|FG001|Participant Flow|Placebo qd + Fulvestrant|Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390065|NCT02437318|OG000|Outcome|Alpelisib qd + Fulvestrant|Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390066|NCT02437318|OG001|Outcome|Placebo qd + Fulvestrant|Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390067|NCT02437318|EG000|Reported Event|Alpelisib qd + Fulvestrant|Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390068|NCT02437318|EG001|Reported Event|Placebo qd + Fulvestrant|Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
11390069|NCT02429791|BG000|Baseline|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390070|NCT02429791|BG001|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390071|NCT02429791|BG002|Baseline|Total|Total of all reporting groups
11390072|NCT02429791|FG000|Participant Flow|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
10803605|NCT03093480|FG000|Participant Flow|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
11390073|NCT02429791|FG001|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390074|NCT02429791|OG000|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390075|NCT02429791|OG001|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390076|NCT02429791|OG000|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390077|NCT02429791|OG000|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390078|NCT02429791|OG001|Outcome|RPV 25 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390079|NCT02429791|OG000|Outcome|CAR-DTG 50 mg|Participants from CAR arm received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
11390080|NCT02429791|OG001|Outcome|CAR-RPV 25 mg|Participants from CAR arm received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
11390081|NCT02429791|EG000|Reported Event|DTG + RPV (Early Switch)|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390082|NCT02429791|EG001|Reported Event|CAR (Early Switch)|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
11390083|NCT02429791|EG002|Reported Event|DTG + RPV (Early + Late Switch)|Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390084|NCT02429791|EG003|Reported Event|CAR (Late Switch)|At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390085|NCT02422797|BG000|Baseline|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390086|NCT02422797|BG001|Baseline|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390087|NCT02422797|BG002|Baseline|Total|Total of all reporting groups
11390088|NCT02422797|FG000|Participant Flow|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390089|NCT02422797|FG001|Participant Flow|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390090|NCT02422797|OG000|Outcome|DTG + RPV|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390091|NCT02422797|OG001|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390092|NCT02422797|OG001|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390093|NCT02422797|OG000|Outcome|Current Antiretroviral Regimen|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with (human immunodeficiency virus-1) HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390094|NCT02422797|OG000|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.
11390095|NCT02422797|OG001|Outcome|RPV 25 mg|Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 148 during early switch and late switch phase.
11390096|NCT02422797|OG000|Outcome|CAR-DTG 50 mg|Participants from CAR arm received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
11241445|NCT02486952|EG000|Reported Event|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11241446|NCT02487030|BG000|Baseline|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
11241447|NCT02487030|BG001|Baseline|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
11241448|NCT02487030|BG002|Baseline|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
11241449|NCT02487030|BG003|Baseline|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
11241450|NCT02487030|BG004|Baseline|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
11241451|NCT02487030|BG005|Baseline|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
11241452|NCT02487030|BG006|Baseline|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
11241453|NCT02487030|BG007|Baseline|Total|Total of all reporting groups
11241454|NCT02487030|FG000|Participant Flow|LDV/SOF 8 wk TN (Cohort 1, Group 1)|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants
11390097|NCT02422797|OG001|Outcome|CAR-RPV 25 mg|Participants from CAR arm received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
11241455|NCT02487030|FG001|Participant Flow|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
11241456|NCT02487030|FG002|Participant Flow|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
11241457|NCT02487030|FG003|Participant Flow|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
11241458|NCT02487030|FG004|Participant Flow|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants
11241459|NCT02487030|FG005|Participant Flow|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
11241460|NCT02487030|FG006|Participant Flow|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2.
11241461|NCT02487030|OG000|Outcome|LDV/SOF 8 wk TN (Cohort 1, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
11241462|NCT02487030|OG001|Outcome|LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
11241463|NCT02487030|OG002|Outcome|LDV/SOF 12 wk TN (Cohort 1, Group 3)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
11241464|NCT02487030|OG003|Outcome|LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
11241465|NCT02487030|OG004|Outcome|LDV/SOF 12 wk TE (Cohort 3, Group 1)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
11241466|NCT02487030|OG005|Outcome|LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
11241467|NCT02487030|OG006|Outcome|LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
11241468|NCT02487030|OG000|Outcome|LDV/SOF 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
11390098|NCT02422797|OG000|Outcome|DTG 50 mg|Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390099|NCT02422797|OG001|Outcome|RPV 25 mg|Participants received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390100|NCT02422797|EG000|Reported Event|DTG + RPV (Early Switch)|Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
11390101|NCT02422797|EG001|Reported Event|CAR (Early Switch)|Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
11390102|NCT02422797|EG002|Reported Event|DTG + RPV (Early + Late Switch)|Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
11390103|NCT02422797|EG003|Reported Event|CAR (Late Switch)|At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
11390104|NCT02287493|BG000|Baseline|Meropenem|Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
11390105|NCT02287493|BG001|Baseline|Ceftazidim|Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
11390106|NCT02287493|BG002|Baseline|Total|Total of all reporting groups
11390107|NCT02287493|FG000|Participant Flow|Meropenem|Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
11390108|NCT02287493|FG001|Participant Flow|Ceftazidim|Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
11390109|NCT02287493|OG000|Outcome|Meropenem|"Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.~Pharmacokinetic Analysis"
11390110|NCT02287493|OG001|Outcome|Ceftazidim|"Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.~Pharmacokinetic Analysis"
11390111|NCT02287493|OG000|Outcome|Meropenem|Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
11390112|NCT02287493|OG001|Outcome|Ceftazidim|Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
11390113|NCT02287493|OG000|Outcome|Meropenem|Adult ICU patients receiving meropenem during SLED will be analyzed
11390114|NCT02287493|OG001|Outcome|Ceftazidim|Adult ICU patients receiving ceftazidim during SLED will be analyzed
11390115|NCT02287493|EG000|Reported Event|Meropenem|Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
11390116|NCT02287493|EG001|Reported Event|Ceftazidim|Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
11390117|NCT02132611|BG000|Baseline|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
11390118|NCT02132611|FG000|Participant Flow|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
11390119|NCT02132611|OG000|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
11390120|NCT02132611|EG000|Reported Event|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
11390121|NCT01147822|BG000|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390122|NCT01147822|BG001|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390123|NCT01147822|BG002|Baseline|Total|Total of all reporting groups
11390124|NCT01147822|FG000|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390125|NCT01147822|FG001|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390126|NCT01147822|OG000|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390127|NCT01147822|OG001|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390128|NCT01147822|EG000|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390129|NCT01147822|EG001|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
11390130|NCT00328653|BG000|Baseline|NOVA22007 0.05%|Cyclosporine NOVA22007 0.05% four times daily
11390131|NCT00328653|BG001|Baseline|NOVA22007 0.1%|Cyclosporine NOVA22007 0.1% four times daily
11390132|NCT00328653|BG002|Baseline|Vehicle|Vehicle administered four times daily
11390133|NCT00328653|BG003|Baseline|Total|Total of all reporting groups
11390134|NCT00328653|FG000|Participant Flow|Vehicle|Vehicle administered four times daily
11390135|NCT00328653|FG001|Participant Flow|NOVA22007 0.05%|Cyclosporine NOVA22007 0.05% four times daily
11390136|NCT00328653|FG002|Participant Flow|NOVA22007 0.1%|Cyclosporine NOVA22007 0.1% four times daily
11390137|NCT00328653|OG000|Outcome|Vehicle|Vehicle administered four times daily
11390138|NCT00328653|OG001|Outcome|NOVA22007 0.05%|Cyclosporine NOVA22007 0.05% four times daily
11390139|NCT00328653|OG002|Outcome|NOVA22007 0.1%|Cyclosporine NOVA22007 0.1% four times daily
11390140|NCT00328653|EG000|Reported Event|Placebo|
11390141|NCT00328653|EG001|Reported Event|Period I- NOVA22007 0.05%|Low Dose Regimen
11390142|NCT00328653|EG002|Reported Event|Period I-NOVA22007 0.1%|High Dose Regimen
11390143|NCT00328653|EG003|Reported Event|Period II- NOVA22007 0.05%|
11390144|NCT00328653|EG004|Reported Event|Period II-NOVA22007 0.1%|
11390145|NCT04476251|BG000|Baseline|Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy|"E7 TCR T Cell Therapy~E7 TCR: Patients will receive up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells)."
11390146|NCT04476251|FG000|Participant Flow|Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy|"E7 TCR T Cell Therapy~E7 TCR: Patients will receive up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells)."
11390147|NCT04476251|OG000|Outcome|Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy|"E7 TCR T Cell Therapy~E7 TCR: Patients will receive up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells)."
11390148|NCT04476251|EG000|Reported Event|Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy|"E7 TCR T Cell Therapy~E7 TCR: Patients will receive up to 3x10^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells)."
11241469|NCT02487030|OG001|Outcome|LDV/SOF + RBV 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
11241470|NCT02487030|OG002|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
11197522|NCT02171260|FG002|Participant Flow|Part A1: Eribulin Mesylate 1.8 mg/m^2|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197523|NCT02171260|FG003|Participant Flow|Part A1: Eribulin Mesylate PK Expansion|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of pharmacokinetics (PK).
11197524|NCT02171260|OG000|Outcome|Part A1: All Participants|All participants received eribulin mesylate 1.1 mg/m^2 or 1.4 mg/m^2 or 1.8 mg/m^2 or 1.4 mg/m^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
11197525|NCT02171260|OG000|Outcome|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
11197526|NCT02171260|OG001|Outcome|Part A1: Eribulin Mesylate 1.4 mg/m^2|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197527|NCT02171260|OG002|Outcome|Part A1: Eribulin Mesylate 1.8 mg/m^2|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197528|NCT02171260|OG003|Outcome|Part A1: Eribulin Mesylate PK Expansion|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
11197529|NCT02171260|OG000|Outcome|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up 4 cycles, or until PD or unacceptable toxicity or DLT's.
10800127|NCT02527434|FG002|Participant Flow|PDAC Cohort|"Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.~Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months."
11197530|NCT02171260|OG000|Outcome|Part A1: Eribulin Mesylate 1.1 mg/m2|Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
11197531|NCT02171260|OG001|Outcome|Part A1: Eribulin Mesylate 1.4 mg/m2|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197532|NCT02171260|OG002|Outcome|Part A1: Eribulin Mesylate 1.8 mg/m2|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197533|NCT02171260|OG000|Outcome|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's
11197534|NCT02171260|EG000|Reported Event|Part A1: Eribulin Mesylate 1.1 mg/m^2|Participants received eribulin mesylate 1.1 milligram mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
11197535|NCT02171260|EG001|Reported Event|Part A1: Eribulin Mesylate 1.4 mg/m^2|Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197536|NCT02171260|EG002|Reported Event|Part A1: Eribulin Mesylate 1.8 mg/m^2|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
11197537|NCT02171260|EG003|Reported Event|Part A1: Eribulin Mesylate PK Expansion|Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
11197538|NCT02171429|BG000|Baseline|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197539|NCT02171429|BG001|Baseline|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11197540|NCT02171429|BG002|Baseline|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11390149|NCT03924765|BG000|Baseline|Individuals Post-stroke Using a Powered Hip Exoskeleton|"This study was conducted on a sample population of stroke subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion in stroke survivors."
11390150|NCT03924765|FG000|Participant Flow|Individuals Post-stroke Using a Powered Hip Exoskeleton|"This study was conducted on a sample population of stroke subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion in stroke survivors."
11390151|NCT03924765|OG000|Outcome|Individuals Post-stroke Using a Powered Hip Exoskeleton|"This study was conducted on a sample population of stroke subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion in stroke survivors."
11390152|NCT03924765|EG000|Reported Event|Individuals Post-stroke Using a Powered Hip Exoskeleton|"This study was conducted on a sample population of stroke subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion in stroke survivors."
11390153|NCT03915860|BG000|Baseline|Trifarotene|Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
11390154|NCT03915860|FG000|Participant Flow|Trifarotene|Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
11390155|NCT03915860|OG000|Outcome|Trifarotene|Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
11390156|NCT03915860|EG000|Reported Event|Trifarotene|Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
11390157|NCT03817606|BG000|Baseline|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.~Study not completed due to COVID-19"
11390158|NCT03817606|BG001|Baseline|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure~Study not completed due to COVID-19."
11390159|NCT03817606|BG002|Baseline|Total|Total of all reporting groups
11390160|NCT03817606|FG000|Participant Flow|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure"
11197541|NCT02171429|BG003|Baseline|Total|Total of all reporting groups
11390161|NCT03817606|FG001|Participant Flow|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure."
11390162|NCT03817606|OG000|Outcome|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure."
11390163|NCT03817606|OG001|Outcome|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure"
11390164|NCT03817606|OG000|Outcome|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.~Study not completed due to COVID-19"
11390165|NCT03817606|OG001|Outcome|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure~Study not completed due to COVID-19."
11390166|NCT03817606|OG000|Outcome|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure"
11390167|NCT03817606|OG001|Outcome|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure."
11390168|NCT03817606|EG000|Reported Event|Tritanium Posterior Lumbar Cage|"Surgical placement of the Tritanium Posterior Lumbar Cage~Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure"
11390169|NCT03817606|EG001|Reported Event|AVS PEEK UniLIF|"Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage~AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure."
11390170|NCT03795233|BG000|Baseline|Fecal Microbiota Transplantation|"Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.~Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation"
11390171|NCT03795233|BG001|Baseline|Oral Vancomycin Alone (Control)|"Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.~Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy."
11390172|NCT03795233|BG002|Baseline|Total|Total of all reporting groups
11390173|NCT03795233|FG000|Participant Flow|Fecal Microbiota Transplantation|"Fecal microbiota transplant (FMT) G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.~Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation"
11390174|NCT03795233|FG001|Participant Flow|Oral Vancomycin Alone (Control)|"Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.~Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy."
11197542|NCT02171429|FG000|Participant Flow|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197543|NCT02171429|FG001|Participant Flow|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11197544|NCT02171429|FG002|Participant Flow|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197545|NCT02171429|OG000|Outcome|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11390175|NCT03795233|OG000|Outcome|Fecal Microbiota Transplantation|"Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.~Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation"
11390176|NCT03795233|OG001|Outcome|Oral Vancomycin Alone (Control)|"Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.~Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy."
11390177|NCT03795233|EG000|Reported Event|Fecal Microbiota Transplantation|"Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection.~Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation"
11390178|NCT03795233|EG001|Reported Event|Oral Vancomycin Alone (Control)|"Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection.~Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy."
11390179|NCT03786380|BG000|Baseline|Relamorelin/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11197546|NCT02171429|OG001|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11390180|NCT03786380|BG001|Baseline|Relamorelin/Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
11390181|NCT03786380|BG002|Baseline|Placebo/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11241471|NCT02487030|OG003|Outcome|LDV/SOF + RBV 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
11390182|NCT03786380|BG003|Baseline|Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390183|NCT03786380|BG004|Baseline|Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390184|NCT03786380|BG005|Baseline|Total|Total of all reporting groups
11390185|NCT03786380|FG000|Participant Flow|Relamorelin/Relamorelin/Relamorelin|Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week randomized withdrawal period (RWP) of RLM-MD-03.
11390186|NCT03786380|FG001|Participant Flow|Relamorelin/Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
11390187|NCT03786380|FG002|Participant Flow|Placebo/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11390188|NCT03786380|FG003|Participant Flow|Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390189|NCT03786380|FG004|Participant Flow|Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390190|NCT03786380|OG000|Outcome|Relamorelin/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11390191|NCT03786380|OG001|Outcome|Relamorelin/Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
11390192|NCT03786380|OG002|Outcome|Placebo/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11390193|NCT03786380|OG003|Outcome|Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390194|NCT03786380|OG004|Outcome|Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390195|NCT03786380|EG000|Reported Event|Relamorelin/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11390196|NCT03786380|EG001|Reported Event|Relamorelin/Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
11197547|NCT02171429|OG000|Outcome|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11241472|NCT02487030|EG000|Reported Event|LDV/SOF 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
11390197|NCT03786380|EG002|Reported Event|Placebo/Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
11390198|NCT03786380|EG003|Reported Event|Relamorelin/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390199|NCT03786380|EG004|Reported Event|Placebo/Relamorelin|Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
11390200|NCT03769376|BG000|Baseline|Bio-Oss®|"Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390201|NCT03769376|BG001|Baseline|Salvin-Oss®|"Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390202|NCT03769376|BG002|Baseline|Total|Total of all reporting groups
11390203|NCT03769376|FG000|Participant Flow|Bio-Oss®|"Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390204|NCT03769376|FG001|Participant Flow|Salvin-Oss®|"Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390205|NCT03769376|OG000|Outcome|Bio-Oss®|"Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390206|NCT03769376|OG001|Outcome|Salvin-Oss®|"Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390207|NCT03769376|EG000|Reported Event|Bio-Oss®|"Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390208|NCT03769376|EG001|Reported Event|Salvin-Oss®|"Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).~Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction."
11390209|NCT03645863|BG000|Baseline|Cohort 1|Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
11390210|NCT03645863|BG001|Baseline|Cohort 2|Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
11390211|NCT03645863|BG002|Baseline|Cohort 3|Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
11390212|NCT03645863|BG003|Baseline|Total|Total of all reporting groups
11390213|NCT03645863|FG000|Participant Flow|Cohort 1|Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
11390214|NCT03645863|FG001|Participant Flow|Cohort 2|Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
11390215|NCT03645863|FG002|Participant Flow|Cohort 3|Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
11390216|NCT03645863|OG000|Outcome|Cohort 1|Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
11390217|NCT03645863|OG001|Outcome|Cohort 2|Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
11390218|NCT03645863|OG002|Outcome|Cohort 3|Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
11241473|NCT02487030|EG001|Reported Event|LDV/SOF + RBV 8 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
11241474|NCT02487030|EG002|Reported Event|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
11390219|NCT03645863|EG000|Reported Event|Cohort 1|Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
11390220|NCT03645863|EG001|Reported Event|Cohort 2|Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
11390221|NCT03645863|EG002|Reported Event|Cohort 3|Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
11390222|NCT03564145|BG000|Baseline|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
11390223|NCT03564145|FG000|Participant Flow|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
11390224|NCT03564145|OG000|Outcome|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
11390225|NCT03564145|EG000|Reported Event|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
11390226|NCT03564119|BG000|Baseline|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11390227|NCT03564119|BG001|Baseline|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11390228|NCT03564119|BG002|Baseline|Total|Total of all reporting groups
11390229|NCT03564119|FG000|Participant Flow|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11390230|NCT03564119|FG001|Participant Flow|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11390231|NCT03564119|OG000|Outcome|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11390232|NCT03564119|OG001|Outcome|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11390233|NCT03564119|EG000|Reported Event|S5G4T-1|Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
11390234|NCT03564119|EG001|Reported Event|S5G4T-2 Vehicle Cream|Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
11390235|NCT03365635|BG000|Baseline|Genotype 1a -Rx Naive -no NS5A Polymorph|"Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390236|NCT03365635|BG001|Baseline|Genotype 1a, Rx Naive + NS5A Polymorph|"Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390237|NCT03365635|BG002|Baseline|Genotype 1b - Rx Naive|"Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390238|NCT03365635|BG003|Baseline|Genotype 1a/1b -Prior INF or NS3/4A|"Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390239|NCT03365635|BG004|Baseline|Genotype4 - Treatment Naive|"(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390240|NCT03365635|BG005|Baseline|Genotype 4- Prior Treatment|"Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390241|NCT03365635|BG006|Baseline|Total|Total of all reporting groups
11390242|NCT03365635|FG000|Participant Flow|Genotype 1a -Rx Naive -no NS5A Polymorph|"Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390243|NCT03365635|FG001|Participant Flow|Genotype 1a, Rx Naive + NS5A Polymorph|"Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390244|NCT03365635|FG002|Participant Flow|Genotype 1b - Rx Naive|"Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390245|NCT03365635|FG003|Participant Flow|Genotype 1a/1b -Prior INF or NS3/4A|"Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390246|NCT03365635|FG004|Participant Flow|Genotype4 - Treatment Naive|"(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390247|NCT03365635|FG005|Participant Flow|Genotype 4- Prior Treatment|"Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390248|NCT03365635|OG000|Outcome|Genotype 1a -Rx Naive -no NS5A Polymorph|"Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390249|NCT03365635|OG001|Outcome|Genotype 1a, Rx Naive + NS5A Polymorph|"Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390250|NCT03365635|OG002|Outcome|Genotype 1b - Rx Naive|"Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390251|NCT03365635|OG003|Outcome|Genotype 1a/1b -Prior INF or NS3/4A|"Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390252|NCT03365635|OG004|Outcome|Genotype4 - Treatment Naive|"(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390253|NCT03365635|OG005|Outcome|Genotype 4- Prior Treatment|"Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390254|NCT03365635|EG000|Reported Event|Genotype 1a -Rx Naive -no NS5A Polymorph|"Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390255|NCT03365635|EG001|Reported Event|Genotype 1a, Rx Naive + NS5A Polymorph|"Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390256|NCT03365635|EG002|Reported Event|Genotype 1b - Rx Naive|"Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390257|NCT03365635|EG003|Reported Event|Genotype 1a/1b -Prior INF or NS3/4A|"Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11197548|NCT02171429|OG001|Outcome|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11390258|NCT03365635|EG004|Reported Event|Genotype4 - Treatment Naive|"(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390259|NCT03365635|EG005|Reported Event|Genotype 4- Prior Treatment|"Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks~Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description"
11390260|NCT03287050|BG000|Baseline|Pembrolizumab + SBRT|"Pembrolizumab: 200 mg IV q 21 days~SBRT: Stereotactic body radiation therapy (SBRT) that will commence not later than the initiation of the second cycle of pembrolizumab. SBRT dose and fractionation will be at the discretion of the treating radiation oncologist, and will be selected to respect the normal tissue tolerance of adjacent organs at risk."
11390261|NCT03287050|FG000|Participant Flow|Pembrolizumab + SBRT|"Pembrolizumab: 200 mg IV q 21 days~SBRT: Stereotactic body radiation therapy (SBRT) that will commence not later than the initiation of the second cycle of pembrolizumab. SBRT dose and fractionation will be at the discretion of the treating radiation oncologist, and will be selected to respect the normal tissue tolerance of adjacent organs at risk."
11197549|NCT02171429|OG002|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197550|NCT02171429|OG000|Outcome|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197551|NCT02171429|EG000|Reported Event|Placebo|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive placebo matching to etrolizumab subcutaneously (SC) once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC once every 2 weeks (Q2W) up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197552|NCT02171429|EG001|Reported Event|Adalimumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive adalimumab subcutaneously (SC) Q2W up to Week 8 (160 mg at Week 0 [Day 1], 80 mg at Week 2, 40 mg at Weeks 4, 6, and 8) and placebo matching to etrolizumab SC Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
11197553|NCT02171429|EG002|Reported Event|Etrolizumab|The double-blinded treatment period consisted of a 10-week induction period and an additional 4-week treatment period for participants who met the definition of clinical remission at Week 10. Participants with moderate-to-severe ulcerative colitis who were naive to TNF inhibitors were randomized to this arm to receive etrolizumab 105 mg subcutaneously (SC) Q4W up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]) and placebo matching to adalimumab SC Q2W up to Week 8 (at Weeks 0 [Day 1], 2, 4, 6, and 8).
11197554|NCT02171611|BG000|Baseline|Overall|This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C)
11197555|NCT02171611|FG000|Participant Flow|A/B/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
11197556|NCT02171611|FG001|Participant Flow|A/C/B|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject.~Treatments were separated by washout period of at least 7 days after drug administration."
11197557|NCT02171611|FG002|Participant Flow|B/A/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
11197558|NCT02171611|FG003|Participant Flow|B/C/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
11197559|NCT02171611|FG004|Participant Flow|C/A/B|Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration.
11197560|NCT02171611|FG005|Participant Flow|C/B/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
11197561|NCT02171611|OG000|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
11241475|NCT02487030|EG003|Reported Event|LDV/SOF + RBV 12 Weeks|LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
11390262|NCT03287050|OG000|Outcome|Pembrolizumab + SBRT|"Pembrolizumab: 200 mg IV q 21 days~SBRT: Stereotactic body radiation therapy (SBRT) that will commence not later than the initiation of the second cycle of pembrolizumab. SBRT dose and fractionation will be at the discretion of the treating radiation oncologist, and will be selected to respect the normal tissue tolerance of adjacent organs at risk."
11390263|NCT03287050|EG000|Reported Event|Pembrolizumab + SBRT|"Pembrolizumab: 200 mg IV q 21 days~SBRT: Stereotactic body radiation therapy (SBRT) that will commence not later than the initiation of the second cycle of pembrolizumab. SBRT dose and fractionation will be at the discretion of the treating radiation oncologist, and will be selected to respect the normal tissue tolerance of adjacent organs at risk."
11390264|NCT03223350|BG000|Baseline|Capsaicin|"0.1% capsaicin cream, one application~Capsaicin 0.1% Cream: Topical application"
11390265|NCT03223350|BG001|Baseline|Placebo|"Topical cream with no active drug~Placebos: placebo cream"
11390266|NCT03223350|BG002|Baseline|Total|Total of all reporting groups
10965852|NCT00884286|EG001|Reported Event|Aplidin® (Cohort Other Lymphomas)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
10965853|NCT00884312|BG000|Baseline|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
10965854|NCT00884312|BG001|Baseline|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11390267|NCT03223350|FG000|Participant Flow|Capsaicin|"0.1% capsaicin cream, one application~Capsaicin 0.1% Cream: Topical application"
11390268|NCT03223350|FG001|Participant Flow|Placebo|"Topical cream with no active drug~Placebos: placebo cream"
11390269|NCT03223350|OG000|Outcome|Capsaicin|"0.1% capsaicin cream, one application~Capsaicin 0.1% Cream: Topical application"
11390270|NCT03223350|OG001|Outcome|Placebo|"Topical cream with no active drug~Placebos: placebo cream"
11390271|NCT03223350|EG000|Reported Event|Capsaicin|"0.1% capsaicin cream, one application~Capsaicin 0.1% Cream: Topical application"
11390272|NCT03223350|EG001|Reported Event|Placebo|"Topical cream with no active drug~Placebos: placebo cream"
11390273|NCT03181828|BG000|Baseline|No Intervention Then Acetohydroxamic Acid Oral Tablet|Participants completed a 4-h study in the fasted state without acetohydroxamic acid. 3 days later, participants then completed an identical 4-h study in the fasted state, after having received a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg).
11390274|NCT03181828|BG001|Baseline|Acetohydroxamic Acid Oral Tablet Then No Intervention|Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study. After completion of the 4-h study, participants then enter a wash-out period of 3 days. Participants then completed an identical 4-h study in the fasted state without acetohydroxamic acid.
11390275|NCT03181828|BG002|Baseline|Total|Total of all reporting groups
11390276|NCT03181828|FG000|Participant Flow|No Intervention, Then Acetohydroxamic Acid Oral Tablet [Lithostat]|Cross over from No Intervention- Non AHA; Period 1. Subjects (healthy adults and UCD patients) will receive a single oral dose of 60 mg/kg acetohydroxamic acid during one of the treatment periods, based on the randomization assignment determining whether treatment occurs in the first or the second treatment cycle; doses will be rounded to the nearest 250 mg to coincide with the available dosage form since the tablets cannot be scored.
11390277|NCT03181828|FG001|Participant Flow|Acetohydroxamic Acid Oral Tablet [Lithostat], Then No Intervention|"All subjects (healthy adults and UCD patients) will receive a single oral dose of 60 mg/kg acetohydroxamic acid during one of the treatment periods, based on the randomization assignment determining whether treatment occurs in the first or the second treatment cycle; doses will be rounded to the nearest 250 mg to coincide with the available dosage form since the tablets cannot be scored. Patients will be instructed to fast for 4 hours prior to the study; subsequently, the 13C-Urea tracer will be administered 60 minutes after the ingestion of the acetohydroxamic acid dose.~Acetohydroxamic Acid Oral Tablet [Lithostat]: AHA:~Acetohydroxamic acid has been an FDA approved medication for the treatment of struvite nephrolithiasis for over 25 years. According to the prescribing information, about 150 patients, including children, have been treated, most for periods of more than 1 year."
11390278|NCT03181828|OG000|Outcome|Acetohydroxamic Acid Oral Tablet|Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study.
11390279|NCT03181828|OG001|Outcome|No Intervention|Participants completed a 4-h study in the fasted state without acetohydroxamic acid.
11390280|NCT03181828|EG000|Reported Event|Acetohydroxamic Acid Oral Tablet|Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study.
11390281|NCT03181828|EG001|Reported Event|No Intervention|Participants completed a 4-h study in the fasted state without acetohydroxamic acid.
10965855|NCT00884312|BG002|Baseline|Total|Total of all reporting groups
10965856|NCT00884312|FG000|Participant Flow|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11390282|NCT03181529|BG000|Baseline|Immediate Treatment|"Participants will begin psilocybin intervention immediately after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session."
11390283|NCT03181529|BG001|Baseline|Delayed Treatment|"Participants will begin the psilocybin intervention 8 weeks after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session."
11390284|NCT03181529|BG002|Baseline|Total|Total of all reporting groups
11390285|NCT03181529|FG000|Participant Flow|Immediate Treatment|"Participants will begin psilocybin intervention immediately after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session (20 mg/70 kg) and a high dose in the second session (30 mg/70 kg), spaced approximately 1-week apart."
11390286|NCT03181529|FG001|Participant Flow|Delayed Treatment|"Participants will begin the psilocybin intervention 8 weeks after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session (20 mg/70 kg) and a high dose in the second session (30 mg/70 kg), spaced approximately 1-week apart."
11390287|NCT03181529|OG000|Outcome|Immediate Treatment|"Participants will begin psilocybin intervention immediately after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session."
11390288|NCT03181529|OG001|Outcome|Delayed Treatment|"Participants will begin the psilocybin intervention 8 weeks after study enrollment.~Psilocybin: Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session."
11390289|NCT03181529|EG000|Reported Event|Session #1 Through 1-week Post-session #1 Follow-up|Participants received a moderately high psilocybin dose (20 mg/70 kg) in the first session, and were assessed for adverse events at follow-up visits.
11390290|NCT03181529|EG001|Reported Event|Session #2 Through 1-week Post-session #2 Follow-up|Participants received a high psilocybin dose (30 mg/70 kg) in the second session, and were assessed for adverse events at follow-up visits.
11197562|NCT02171611|OG001|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
11197563|NCT02171611|OG002|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
11390291|NCT02946931|BG000|Baseline|Prizbind® for Intravenous Solution|Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
11390292|NCT02946931|FG000|Participant Flow|Prizbind® for Intravenous Solution|Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
11390293|NCT02946931|OG000|Outcome|Prizbind® for Intravenous Solution|Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
11390294|NCT02946931|EG000|Reported Event|Prizbind® for Intravenous Solution|Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
11390295|NCT02779556|BG000|Baseline|Enhanced Usual Care|"ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months~ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook"
11390296|NCT02779556|BG001|Baseline|Intervention|"ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months~ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide"
11390297|NCT02779556|BG002|Baseline|Total|Total of all reporting groups
11390298|NCT02779556|FG000|Participant Flow|Enhanced Usual Care|"ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months~ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook"
11390299|NCT02779556|FG001|Participant Flow|Intervention|"ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months~ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide"
11390300|NCT02779556|OG000|Outcome|Enhanced Usual Care|"ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months~ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook"
11390301|NCT02779556|OG001|Outcome|Intervention|"ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months~ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide"
11390302|NCT02779556|EG000|Reported Event|Enhanced Usual Care|"ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months~ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook"
11390303|NCT02779556|EG001|Reported Event|Intervention|"ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months~ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide"
11390304|NCT02724774|BG000|Baseline|Promoting First Relationships® (PFR)|"10 week home visiting program~Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting."
10800128|NCT02527434|OG000|Outcome|UBC - Tremelimumab Monotherapy|Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11390305|NCT02724774|BG001|Baseline|Parent Information Packet|A packet is mailed to the families, including handouts related to child development, health, and local resources.
11390306|NCT02724774|BG002|Baseline|Total|Total of all reporting groups
11390307|NCT02724774|FG000|Participant Flow|Promoting First Relationships® (PFR)|"10 week home visiting program~Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting."
11390308|NCT02724774|FG001|Participant Flow|Parent Information Packet|A packet is mailed to the families, including handouts related to child development, health, and local resources.
11390309|NCT02724774|OG000|Outcome|Promoting First Relationships® (PFR)|"10 week home visiting program~Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting."
11390310|NCT02724774|OG001|Outcome|Parent Information Packet|A packet is mailed to the families, including handouts related to child development, health, and local resources.
11390311|NCT02724774|EG000|Reported Event|Promoting First Relationships® (PFR)|"10 week home visiting program~Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting."
11390312|NCT02724774|EG001|Reported Event|Parent Information Packet|A packet is mailed to the families, including handouts related to child development, health, and local resources.
11390313|NCT02675751|BG000|Baseline|PRK Correction With iDesign System and STAR S4 IR Laser|Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
11390314|NCT02675751|FG000|Participant Flow|PRK Correction With iDesign System and STAR S4 IR Laser|Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
11390315|NCT02675751|OG000|Outcome|PRK Correction With iDesign System and STAR S4 IR Laser|Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
11390316|NCT02675751|EG000|Reported Event|PRK Correction With iDesign System and STAR S4 IR Laser|Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
11390317|NCT02643381|BG000|Baseline|Etomidate|"Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390318|NCT02643381|BG001|Baseline|Ketamine|"Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390319|NCT02643381|BG002|Baseline|Total|Total of all reporting groups
11390320|NCT02643381|FG000|Participant Flow|Etomidate|"Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390321|NCT02643381|FG001|Participant Flow|Ketamine|"Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390322|NCT02643381|OG000|Outcome|Etomidate|"Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11241476|NCT02487056|BG000|Baseline|JourneyHF-TR|The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.
11390323|NCT02643381|OG001|Outcome|Ketamine|"Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390324|NCT02643381|EG000|Reported Event|Etomidate|"Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Etomidate: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390325|NCT02643381|EG001|Reported Event|Ketamine|"Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Ketamine: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.~Emergency Endotracheal Intubation: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.~Mechanical Ventilation: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators."
11390326|NCT02621424|BG000|Baseline|RTMS|"repetitive transcranial magnetic stimulation~RTMS: stimulation of the brain with magnetic pulses"
11390327|NCT02621424|BG001|Baseline|Sham|"sham noise to block the sound of treatment~sham: sham noise to block the sound of stimulation"
11390328|NCT02621424|BG002|Baseline|Total|Total of all reporting groups
11390329|NCT02621424|FG000|Participant Flow|RTMS|"repetitive transcranial magnetic stimulation~RTMS: stimulation of the brain with magnetic pulses"
11390330|NCT02621424|FG001|Participant Flow|Sham|"sham noise to block the sound of treatment~sham: sham noise to block the sound of stimulation"
11390331|NCT02621424|OG000|Outcome|RTMS|"repetitive transcranial magnetic stimulation~RTMS: stimulation of the brain with magnetic pulses"
11390332|NCT02621424|OG001|Outcome|Sham|"sham noise to block the sound of treatment~sham: sham noise to block the sound of stimulation"
11390333|NCT02621424|EG000|Reported Event|RTMS|"repetitive transcranial magnetic stimulation~mild headache and irritation at the site of stimulation were reported and thought to be treatment-related. These event were mild and only lasted a day or two.~There were other reported events and were reviewed with the IRB. They were determined to be not related to RTMS treatment."
11390334|NCT02621424|EG001|Reported Event|Sham|"sham noise to block the sound of treatment Low amplitude electrical stimulation was used to simulate the sensation of RTMS. The electrical stimulation to the scalp can cause mild sense of irritation, which only occurs when the stimulation is turned on.~There were other reported events and were reviewed with the IRB. They were determined to be not related to RTMS treatment."
11390335|NCT02595372|BG000|Baseline|High Dose Omeprazole Treatment|Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
11390336|NCT02595372|FG000|Participant Flow|High Dose Omeprazole Treatment|Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
11390337|NCT02595372|OG000|Outcome|High Dose Omeprazole Treatment|Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
11390338|NCT02595372|EG000|Reported Event|High Dose Omeprazole Treatment|Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
11390339|NCT02334722|BG000|Baseline|1 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.~Levetiracetam"
11390340|NCT02334722|BG001|Baseline|6 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.~Levetiracetam"
11390341|NCT02334722|BG002|Baseline|Total|Total of all reporting groups
11390342|NCT02334722|FG000|Participant Flow|1 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.~Levetiracetam"
11390343|NCT02334722|FG001|Participant Flow|6 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.~Levetiracetam"
11390344|NCT02334722|OG000|Outcome|1 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.~Levetiracetam"
11390345|NCT02334722|OG001|Outcome|6 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.~Levetiracetam"
11390346|NCT02334722|EG000|Reported Event|1 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.~Levetiracetam"
11390347|NCT02334722|EG001|Reported Event|6 Week Levetiracetam|"Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.~Levetiracetam"
11390348|NCT02259725|BG000|Baseline|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO~laboratory biomarker analysis: Correlative studies"
11390349|NCT02259725|FG000|Participant Flow|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO~laboratory biomarker analysis: Correlative studies"
11390350|NCT02259725|OG000|Outcome|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO~laboratory biomarker analysis: Correlative studies"
11390351|NCT02259725|EG000|Reported Event|Treatment (Regorafenib)|"Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~regorafenib: Given PO~laboratory biomarker analysis: Correlative studies"
11390352|NCT01966731|BG000|Baseline|Hydroxyurea|Hydroxyurea administered at 15-20 mg/kg/ day as a single daily dose.
11390353|NCT01966731|FG000|Participant Flow|Hydroxyurea|Hydroxyurea dosing was administered as a single daily dose, in 200mg, 300mg, 400mg, or 500mg sizes
11390354|NCT01966731|OG000|Outcome|Hydroxyurea|Hydroxyurea dosing was administered as a single daily dose, in 200mg, 300mg, 400mg, or 500mg sizes
11390355|NCT01966731|EG000|Reported Event|Hydroxyurea|Hydroxyurea administered at 15-20 mg/kg/ day as a single daily dose.
11390356|NCT01952288|BG000|Baseline|Simvastatin|"simvastatin 40 mg/day~simvastatin: simvastatin 40 mg/day for 12 months"
11390357|NCT01952288|BG001|Baseline|Placebo|"placebo~Placebo Oral Tablet: placebo comparator"
11390358|NCT01952288|BG002|Baseline|Total|Total of all reporting groups
11390359|NCT01952288|FG000|Participant Flow|Simvastatin|"simvastatin 40 mg/day~simvastatin: simvastatin 40 mg/day for 12 months"
11390360|NCT01952288|FG001|Participant Flow|Placebo|"placebo~Placebo Oral Tablet: placebo comparator"
11390361|NCT01952288|OG000|Outcome|Simvastatin|"simvastatin 40 mg/day~simvastatin: simvastatin 40 mg/day for 12 months"
11390362|NCT01952288|OG001|Outcome|Placebo|"placebo~Placebo Oral Tablet: placebo comparator"
11390363|NCT01952288|EG000|Reported Event|Simvastatin|"simvastatin 40 mg/day~simvastatin: simvastatin 40 mg/day for 12 months"
11390364|NCT01952288|EG001|Reported Event|Placebo|"placebo~Placebo Oral Tablet: placebo comparator"
10800129|NCT02527434|OG001|Outcome|TNBC - Tremelimumab Monotherapy|Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11197564|NCT02171611|EG000|Reported Event|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
11390365|NCT01850082|BG000|Baseline|Endoscopic Vein Harvest (EVH)|"An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390366|NCT01850082|BG001|Baseline|Open Vein Harvest (OVH)|"Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as bridging technique) along the course of the vein.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390367|NCT01850082|BG002|Baseline|Total|Total of all reporting groups
11390368|NCT01850082|FG000|Participant Flow|Endoscopic Vein Harvest (EVH)|"An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
10800130|NCT02527434|OG002|Outcome|PDAC - Tremelimumab Monotherapy|Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11390369|NCT01850082|FG001|Participant Flow|Open Vein Harvest (OVH)|"Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as bridging technique) along the course of the vein.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390370|NCT01850082|OG000|Outcome|Endoscopic Vein Harvest (EVH)|"An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390371|NCT01850082|OG001|Outcome|Open Vein Harvest (OVH)|"Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as bridging technique) along the course of the vein.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390372|NCT01850082|EG000|Reported Event|Endoscopic Vein Harvest (EVH)|"An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390373|NCT01850082|EG001|Reported Event|Open Vein Harvest (OVH)|"Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as bridging technique) along the course of the vein.~Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
11390374|NCT01844518|BG000|Baseline|SC Abatacept Ages 6 to 17|SC abatacept administered by PFS once weekly according to weight-tiered dose regimen as follows: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390375|NCT01844518|BG001|Baseline|SC Abatacept Ages 2 to 5|SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390376|NCT01844518|BG002|Baseline|Total|Total of all reporting groups
11390377|NCT01844518|FG000|Participant Flow|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390378|NCT01844518|FG001|Participant Flow|SC Abatacept Ages 2 to 5|SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390379|NCT01844518|OG000|Outcome|SC Abatacept Ages 6 to 17|SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390380|NCT01844518|OG000|Outcome|10 to <25 kg Dosing Group|Weight-tiered dosing group received 50 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.
11390381|NCT01844518|OG001|Outcome|25 to <50 kg Dosing Group|Weight-tiered dosing group received 87.5 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.
11390382|NCT01844518|OG002|Outcome|>=50 kg Dosing Group|Weight-tiered dosing group received 125 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly
11390383|NCT01844518|OG001|Outcome|SC Abatacept Ages 2 to 5|SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390384|NCT01844518|EG000|Reported Event|SC Abatacept Ages 6 to 17|SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11390385|NCT01844518|EG001|Reported Event|SC Abatacept Ages 2 to 5|SC abatacept administered by PFS once weekly according to weight-tiered dose regimen as follows: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
11241477|NCT02487056|FG000|Participant Flow|JourneyHF-TR|The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.
11390386|NCT01675479|BG000|Baseline|Wavefront-Guided LASIK|LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
11241478|NCT02487056|OG000|Outcome|Hospitalized Patients With Acute Heart Failure|The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units
11241479|NCT02487056|OG000|Outcome|JourneyHF-TR|The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.
11241480|NCT02487056|EG000|Reported Event|Hospitalized Patients With Acute Heart Failure|The Journey HF-TR study is a cross-sectional, multicenter, non-invasive and observational trial that was conducted in intensive/coronary care units and cardiology wards. The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.
11241481|NCT02487199|BG000|Baseline|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11241482|NCT02487199|BG001|Baseline|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
11241483|NCT02487199|BG002|Baseline|Total|Total of all reporting groups
11241484|NCT02487199|FG000|Participant Flow|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11241485|NCT02487199|FG001|Participant Flow|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
11241486|NCT02487199|OG000|Outcome|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11241487|NCT02487199|OG001|Outcome|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
11241488|NCT02487199|EG000|Reported Event|HCV GT1a (3-DAA)|Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11241489|NCT02487199|EG001|Reported Event|HCV GT4 (2-DAA)|Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
11241490|NCT02487225|BG000|Baseline|Pentoxifylline|"Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Pentoxifylline: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors"
11390387|NCT01675479|FG000|Participant Flow|Wavefront-Guided LASIK|LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
11390388|NCT01675479|OG000|Outcome|Wavefront-Guided LASIK|LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
11241491|NCT02487225|BG001|Baseline|Placebo|"Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Placebo: A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug"
11241492|NCT02487225|BG002|Baseline|Total|Total of all reporting groups
11241493|NCT02487225|FG000|Participant Flow|Pentoxifylline|"Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Pentoxifylline: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors"
11241494|NCT02487225|FG001|Participant Flow|Placebo|"Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Placebo: A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug"
11241495|NCT02487225|OG000|Outcome|Pentoxifylline|"Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Pentoxifylline: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors"
11390389|NCT01675479|EG000|Reported Event|Wavefront-Guided LASIK|LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
11241496|NCT02487225|OG001|Outcome|Placebo|"Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Placebo: A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug"
11390390|NCT00812708|BG000|Baseline|Morcher Iris Diaphragm Study Group|Seventy two patients signed consent forms to participate in the Morcher iris diaphragm study.
11390391|NCT00812708|FG000|Participant Flow|Morcher Iris Diaphragm Study Group|This group consists of all patients enrolled in the Morcher iris diaphragm study.
11390392|NCT00812708|OG000|Outcome|Morcher Iris Diaphragm Implantation Group|All patients implanted with Morcher iris diaphragms.
11390393|NCT00812708|OG000|Outcome|Morcher Iris Diaphragm Implantation Group|Glare sensitivity was assessed by a questionnaire that was scored on a 0 to 10 scale under daytime and nighttime lighting conditions.
11390394|NCT00812708|EG000|Reported Event|Morcher Iris Diaphragm Implantation Group|All patients implanted with Morcher iris diaphragms
11390395|NCT00741988|BG000|Baseline|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
11390396|NCT00741988|BG001|Baseline|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
11390397|NCT00741988|BG002|Baseline|Total|Total of all reporting groups
11390398|NCT00741988|FG000|Participant Flow|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
11390399|NCT00741988|FG001|Participant Flow|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
11390400|NCT00741988|OG000|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
11390401|NCT00741988|OG001|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
11390402|NCT00741988|EG000|Reported Event|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
11390403|NCT00741988|EG001|Reported Event|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
11390404|NCT00563576|BG000|Baseline|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
11390405|NCT00563576|BG001|Baseline|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
11390406|NCT00563576|BG002|Baseline|Total|Total of all reporting groups
11390407|NCT00563576|FG000|Participant Flow|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
11390408|NCT00563576|FG001|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
11390409|NCT00563576|OG000|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
11390410|NCT00563576|OG001|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
11390411|NCT00563576|EG000|Reported Event|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
11390412|NCT00563576|EG001|Reported Event|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
11390413|NCT00515671|BG000|Baseline|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390414|NCT00515671|BG001|Baseline|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390415|NCT00515671|BG002|Baseline|Total|Total of all reporting groups
11390416|NCT00515671|FG000|Participant Flow|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390417|NCT00515671|FG001|Participant Flow|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390418|NCT00515671|OG000|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390419|NCT00515671|OG001|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390420|NCT00515671|EG000|Reported Event|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390421|NCT00515671|EG001|Reported Event|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
11390422|NCT00455403|BG000|Baseline|Chloroquine Subjects|"Participants will receive 80 mg of chloroquine on a daily basis.~Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24"
11390423|NCT00455403|BG001|Baseline|Placebo Subjects|"Participants will receive a placebo comparator tablet on a daily basis.~Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24"
11390424|NCT00455403|BG002|Baseline|Total|Total of all reporting groups
11390425|NCT00455403|FG000|Participant Flow|Chloroquine Subjects|"Participants will receive 80 mg of chloroquine on a daily basis.~Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24"
11390426|NCT00455403|FG001|Participant Flow|Placebo Subjects|"Participants will receive a placebo comparator tablet on a daily basis.~Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24"
11390427|NCT00455403|OG000|Outcome|Chloroquine Subjects|"Participants will receive 80 mg of chloroquine on a daily basis.~Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24"
11390428|NCT00455403|OG001|Outcome|Placebo Subjects|"Participants will receive a placebo comparator tablet on a daily basis.~Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24"
11390429|NCT00455403|EG000|Reported Event|Chloroquine Subjects|"Participants will receive 80 mg of chloroquine on a daily basis.~Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24"
11390430|NCT00455403|EG001|Reported Event|Placebo Subjects|"Participants will receive a placebo comparator tablet on a daily basis.~Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24"
11390431|NCT00238420|BG000|Baseline|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
11390432|NCT00238420|BG001|Baseline|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
11390433|NCT00238420|BG002|Baseline|Total|Total of all reporting groups
11390434|NCT00238420|FG000|Participant Flow|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
11390435|NCT00238420|FG001|Participant Flow|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
11390436|NCT00238420|OG000|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
11390437|NCT00238420|OG001|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
11390438|NCT00238420|EG000|Reported Event|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
11390439|NCT00238420|EG001|Reported Event|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
10965857|NCT00884312|FG001|Participant Flow|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11197565|NCT02171611|EG001|Reported Event|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
11197566|NCT02171611|EG002|Reported Event|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
11197567|NCT02171819|BG000|Baseline|IVACFLU-A/H5N1, 7.5 mcg|IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
11197568|NCT02171819|BG001|Baseline|IVACFLU-A/H5N1, 15 mcg|IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
11197569|NCT02171819|BG002|Baseline|Placebo|phosphate buffered saline, given IM at Day 0 and Day 21.
11197570|NCT02171819|BG003|Baseline|Total|Total of all reporting groups
11197571|NCT02171819|FG000|Participant Flow|IVACFLU-A/H5N1, 7.5 mcg|IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
11197572|NCT02171819|FG001|Participant Flow|IVACFLU-A/H5N1, 15 mcg|IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
11197573|NCT02171819|FG002|Participant Flow|Placebo|phosphate buffered saline, given IM at Day 0 and Day 21.
11197574|NCT02171819|OG000|Outcome|IVACFLU-A/H5N1, 7.5 mcg|IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
11197575|NCT02171819|OG001|Outcome|IVACFLU-A/H5N1, 15 mcg|IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
11197576|NCT02171819|OG002|Outcome|Combined Vaccine|Results of low and high doses combined
11197577|NCT02171819|OG003|Outcome|Placebo|phosphate buffered saline, given IM at Day 0 and Day 21
11197578|NCT02171819|OG002|Outcome|Combined Vaccine|The high- and low-dose vaccine participants combined
11197579|NCT02171819|OG002|Outcome|Placebo|phosphate buffered saline, given at Day 0 and Day 21
11197580|NCT02171819|OG002|Outcome|Combined Vaccine|Low and high dose groups combined
11197581|NCT02171819|EG000|Reported Event|IVACFLU-A/H5N1, 7.5 mcg|IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
11197582|NCT02171819|EG001|Reported Event|IVACFLU-A/H5N1, 15 mcg|IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
11197583|NCT02171819|EG002|Reported Event|Placebo|phosphate buffered saline, given IM at Day 0 and Day 21.
11197584|NCT02172040|BG000|Baseline|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
11197585|NCT02172040|BG001|Baseline|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
11197586|NCT02172040|BG002|Baseline|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197587|NCT02172040|BG003|Baseline|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197588|NCT02172040|BG004|Baseline|Total|Total of all reporting groups
11197589|NCT02172040|FG000|Participant Flow|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
11197590|NCT02172040|FG001|Participant Flow|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
11197591|NCT02172040|FG002|Participant Flow|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197592|NCT02172040|FG003|Participant Flow|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197593|NCT02172040|OG000|Outcome|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
11197594|NCT02172040|OG001|Outcome|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
11197595|NCT02172040|OG002|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197596|NCT02172040|OG003|Outcome|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197597|NCT02172040|OG001|Outcome|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197598|NCT02172040|EG000|Reported Event|Amlodipine+Celecoxib|"Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks"
11197599|NCT02172040|EG001|Reported Event|Amlodipine+Placebo|"Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks"
11197600|NCT02172040|EG002|Reported Event|Placebo+Celecoxib|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197601|NCT02172040|EG003|Reported Event|Placebo+Placebo|"Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks~Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks"
11197602|NCT02172625|BG000|Baseline|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
11197603|NCT02172625|BG001|Baseline|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
11197604|NCT02172625|BG002|Baseline|Total|Total of all reporting groups
11197605|NCT02172625|FG000|Participant Flow|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
11197606|NCT02172625|FG001|Participant Flow|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
11197607|NCT02172625|OG000|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
11197608|NCT02172625|OG001|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
11197609|NCT02172625|OG001|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
11390440|NCT04328961|BG000|Baseline|Ascorbic Acid|"Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days~Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy."
11390441|NCT04328961|BG001|Baseline|Hydroxychloroquine|"Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days~Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy"
11390442|NCT04328961|BG002|Baseline|Total|Total of all reporting groups
11390443|NCT04328961|FG000|Participant Flow|Ascorbic Acid|"Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days~Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy."
11390444|NCT04328961|FG001|Participant Flow|Hydroxychloroquine|"Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days~Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy"
11390445|NCT04328961|OG000|Outcome|Ascorbic Acid|"Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days~Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy."
11390446|NCT04328961|OG001|Outcome|Hydroxychloroquine|"Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days~Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy"
11390447|NCT04328961|EG000|Reported Event|Ascorbic Acid|"Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days~Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy."
11390448|NCT04328961|EG001|Reported Event|Hydroxychloroquine|"Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days~Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy"
10800131|NCT02527434|OG000|Outcome|UBC - COMBO|Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
11390449|NCT04128319|BG000|Baseline|T-Guard Treatment|"Patients will receive T-Guard for treatment of steroid-refractory acute GVHD.~T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA)."
11390450|NCT04128319|FG000|Participant Flow|T-Guard Treatment|"Patients will receive T-Guard for treatment of steroid-refractory acute GVHD.~T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA)."
11390451|NCT04128319|OG000|Outcome|T-Guard Treatment|"Patients will receive T-Guard for treatment of steroid-refractory acute GVHD.~T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA)."
11390452|NCT04128319|EG000|Reported Event|T-Guard Treatment|"Patients will receive T-Guard for treatment of steroid-refractory acute GVHD.~T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA)."
11390453|NCT03761810|BG000|Baseline|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390454|NCT03761810|BG001|Baseline|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390455|NCT03761810|BG002|Baseline|Total|Total of all reporting groups
11390456|NCT03761810|FG000|Participant Flow|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390457|NCT03761810|FG001|Participant Flow|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390458|NCT03761810|OG000|Outcome|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390459|NCT03761810|OG001|Outcome|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390460|NCT03761810|EG000|Reported Event|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390461|NCT03761810|EG001|Reported Event|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390462|NCT03761784|BG000|Baseline|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390463|NCT03761784|BG001|Baseline|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390464|NCT03761784|BG002|Baseline|Total|Total of all reporting groups
11390465|NCT03761784|FG000|Participant Flow|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390466|NCT03761784|FG001|Participant Flow|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390467|NCT03761784|OG000|Outcome|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390468|NCT03761784|OG001|Outcome|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390469|NCT03761784|EG000|Reported Event|S6G5T-3|Participants topically applied S6G5T-3, once daily to face for 12 weeks.
11390470|NCT03761784|EG001|Reported Event|S6G5T-8 Vehicle Cream|Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
11390471|NCT03361865|BG000|Baseline|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11390472|NCT03361865|BG001|Baseline|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously every 3 weeks. Matching placebo administered orally twice daily.
11390473|NCT03361865|BG002|Baseline|Total|Total of all reporting groups
11390474|NCT03361865|FG000|Participant Flow|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11197610|NCT02172625|OG001|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
11197611|NCT02172625|OG000|Outcome|Placebo Group|"Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
11197612|NCT02172625|OG001|Outcome|Protandim Group|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
11197613|NCT02172625|EG000|Reported Event|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
11197614|NCT02172625|EG001|Reported Event|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
11197615|NCT02172664|BG000|Baseline|All Study Participants|All participants received both interventions.
11197616|NCT02172664|FG000|Participant Flow|Adhese Universal With Self Etch Enamel Etching|"patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching~Self etch enamel etching: The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.~Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions"
11197617|NCT02172664|FG001|Participant Flow|Selective Etch Protocol Followed by Adhese Universal|"patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)~selective etch protocol: Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.~Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions"
11197618|NCT02172664|OG000|Outcome|Adhese Universal With Self Etch Enamel Etching|"patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching~Self etch enamel etching: The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.~Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions"
11197619|NCT02172664|OG001|Outcome|Selective Etch Protocol Followed by Adhese Universal|"patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)~selective etch protocol: Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.~Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions"
10965858|NCT00884312|OG000|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11197620|NCT02172664|EG000|Reported Event|All Study Participants|Adverse events were not monitored per intervention.
11197621|NCT02172742|BG000|Baseline|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
11197622|NCT02172742|BG001|Baseline|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
11197623|NCT02172742|BG002|Baseline|Total|Total of all reporting groups
11197624|NCT02172742|FG000|Participant Flow|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
11197625|NCT02172742|FG001|Participant Flow|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
11197626|NCT02172742|OG000|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
11197627|NCT02172742|EG000|Reported Event|BIA 2-093+Digoxin|BIA 2-093 + Digoxin
11197628|NCT02172742|EG001|Reported Event|Placebo+Digoxin|Placebo + Digoxin
11197629|NCT02172755|BG000|Baseline|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11390475|NCT03361865|FG001|Participant Flow|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously every 3 weeks. Matching placebo administered orally twice daily.
11390476|NCT03361865|OG000|Outcome|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11390477|NCT03361865|OG001|Outcome|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously every 3 weeks. Matching placebo administered orally twice daily.
11390478|NCT03361865|EG000|Reported Event|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously every 3 weeks. Epacadostat administered orally twice daily.
11390479|NCT03361865|EG001|Reported Event|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously every 3 weeks. Matching placebo administered orally twice daily.
11390480|NCT03361865|EG002|Reported Event|Total|Total
11390481|NCT03294304|BG000|Baseline|Nivolumab, Cisplatin, & Gemcitabine|"Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.~Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.~Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles."
11390482|NCT03294304|FG000|Participant Flow|Nivolumab, Cisplatin, & Gemcitabine|"Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.~Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.~Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles."
11390483|NCT03294304|OG000|Outcome|Nivolumab, Cisplatin, & Gemcitabine|"Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.~Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.~Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles."
11390484|NCT03294304|EG000|Reported Event|Nivolumab, Cisplatin, & Gemcitabine|"Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.~Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.~Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles."
11390485|NCT03122431|BG000|Baseline|Inactive SLE With Standard Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
11390486|NCT03122431|BG001|Baseline|Inactive SLE With Reduced Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight).
11390487|NCT03122431|BG002|Baseline|SLE/Cutaneous Lupus With Thalidomide|This subproject includes only one arm of lupus patients with active and refractory cutaneous disease and eligible for Thalidomide 100mg/day for 12 months.
11390488|NCT03122431|BG003|Baseline|Total|Total of all reporting groups
11390489|NCT03122431|FG000|Participant Flow|Inactive SLE With Standard Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
11390490|NCT03122431|FG001|Participant Flow|Inactive SLE With Reduced Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight)
11390491|NCT03122431|FG002|Participant Flow|SLE/Cutaneous Lupus With Thalidomide|"Adult patients with CLE (biopsy proven)/SLE (American College of Rheumatology classification criteria, 1997) treated with thalidomide.~Inclusion criteria:~absence of pregnancy potential for females;~agreement of male patients to use condoms throughout the treatment period with thalidomide and up to 30 days after its ending, even though they had already undergone vasectomy;~active skin lesions;~no response to previous use of HCQ, prednisone 20 mg/day, and immunosuppressants/dapsone or indication of thalidomide according to the attending physician; 5) agreement of recruited patients to participate in the study according to signed informed consent form, and agreement to thalidomide use according to signed responsibility term at starting treatment and at each renewal of the prescription; 6) a normal NCS;~7) normal serum vitamin B12 levels; 8) negative tests for hepatitis B/C and HIV; 9) negative antiphospholipid antibodies.~Exclusion criteria:~other associated autoimmune diseases, such as Sjogren's syndrome;~previous or current alcoholism;~diabetes mellitus;~history of PN;~previous use of thalidomide;~previous or current use of leflunomide, TNF-alpha inhibitors, chemotherapy and other neurotoxic drugs;~history of cancer or thrombosis;~current renal or nervous system lupus activities, autoimmune haemolytic anaemia and/or thrombocytopenia <50,000/mm3;~inability to understand the study."
11390492|NCT03122431|OG000|Outcome|SLE/Cutaneous Lupus With Thalidomide|Adult patients with CLE (biopsy proven)/SLE (American College of Rheumatology classification criteria, 1997) treated with thalidomide.
11390493|NCT03122431|OG000|Outcome|Inactive SLE With Standard Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
11390494|NCT03122431|OG001|Outcome|Inactive SLE With Reduced Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight)
11390495|NCT03122431|EG000|Reported Event|SLE/Cutaneous Lupus With Thalidomide|SLE/cutaneous lupus with thalidomide arm (12 months).
11390496|NCT03122431|EG001|Reported Event|Inactive SLE With Standard Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
11390497|NCT03122431|EG002|Reported Event|Inactive SLE With Reduced Dose of HCQ|Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight).
11390498|NCT02929056|BG000|Baseline|SOC Alginate Dressing|"SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement~SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing"
11390499|NCT02929056|BG001|Baseline|AmnioExCel Dressing|"AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement~AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers"
11390500|NCT02929056|BG002|Baseline|Total|Total of all reporting groups
11390501|NCT02929056|FG000|Participant Flow|SOC Alginate Dressing|"SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement~SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing"
11390502|NCT02929056|FG001|Participant Flow|AmnioExCel Dressing|"AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement~AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers"
11390503|NCT02929056|OG000|Outcome|SOC Alginate Dressing|"SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement~SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing"
11390504|NCT02929056|OG001|Outcome|AmnioExCel Dressing|"AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement~AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers"
11390505|NCT02929056|EG000|Reported Event|SOC Alginate Dressing|"SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement~SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing"
11390506|NCT02929056|EG001|Reported Event|AmnioExCel Dressing|"AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement~AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers"
11390507|NCT02896855|BG000|Baseline|Arm A: Placebo + Trastuzumab + Docetaxel|Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.
11390508|NCT02896855|BG001|Baseline|Arm B: Pertuzumab + Trastuzumab + Docetaxel|Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390509|NCT02896855|BG002|Baseline|Total|Total of all reporting groups
11390510|NCT02896855|FG000|Participant Flow|Arm A: Placebo + Trastuzumab + Docetaxel|Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.
11390511|NCT02896855|FG001|Participant Flow|Arm B: Pertuzumab + Trastuzumab + Docetaxel|Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390512|NCT02896855|OG000|Outcome|Arm A: Placebo + Trastuzumab + Docetaxel|Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity. Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel.
11390513|NCT02896855|OG001|Outcome|Arm B: Pertuzumab + Trastuzumab + Docetaxel|Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390514|NCT02896855|OG000|Outcome|Arm A: Placebo + Trastuzumab + Docetaxel|Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity.
10965859|NCT00884312|OG001|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11197630|NCT02172755|BG001|Baseline|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11390515|NCT02896855|OG002|Outcome|Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel|Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel. Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390516|NCT02896855|EG000|Reported Event|Arm A: Placebo + Trastuzumab + Docetaxel|Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]) were administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity.
11390517|NCT02896855|EG001|Reported Event|Arm B: Pertuzumab + Trastuzumab + Docetaxel|Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390518|NCT02896855|EG002|Reported Event|Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel|Following the primary analysis and upon approval of protocol version 4 (07-March-2020), the treatment assignment of participants in Arm A who were still on study treatment was unblinded, allowing the investigators to present those participants with the option to cross over and receive pertuzumab (in place of placebo) in addition to trastuzumab and docetaxel. Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2) were administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
11390519|NCT02871778|BG000|Baseline|Part A: VX-371 in HS, Then HS|Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS twice daily through oral nebulized inhalation from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390520|NCT02871778|BG001|Baseline|Part A: HS, Then VX-371 in HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390521|NCT02871778|BG002|Baseline|Part A: VX-371, Then Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390522|NCT02871778|BG003|Baseline|Part A: Placebo, Then VX-371|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390523|NCT02871778|BG004|Baseline|Total|Total of all reporting groups
11390524|NCT02871778|FG000|Participant Flow|Part A: VX-371 in Hypertonic Saline (HS), Then HS|Participants received 85 microgram (mcg) VX-371 diluted in 3 milliliter (mL) 4.2 percent (%) HS twice daily through oral nebulized inhalation from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390525|NCT02871778|FG001|Participant Flow|Part A: HS, Then VX-371 in HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390526|NCT02871778|FG002|Participant Flow|Part A: VX-371, Then Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390527|NCT02871778|FG003|Participant Flow|Part A: Placebo, Then VX-371|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
11390528|NCT02871778|FG004|Participant Flow|Part B: VX-371 in HS + Ivacaftor|Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
10965860|NCT00884312|EG000|Reported Event|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11197631|NCT02172755|BG002|Baseline|Total|Total of all reporting groups
11390529|NCT02871778|FG005|Participant Flow|Part B: HS + Ivacaftor|Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390530|NCT02871778|FG006|Participant Flow|Part B: VX-371 + Ivacaftor|Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390531|NCT02871778|FG007|Participant Flow|Part B: Placebo + Ivacaftor|Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390532|NCT02871778|OG000|Outcome|Part A: VX-371 in HS|Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390533|NCT02871778|OG001|Outcome|Part A: HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390534|NCT02871778|OG002|Outcome|Part A: VX-371|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390535|NCT02871778|OG003|Outcome|Part A: Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390536|NCT02871778|OG000|Outcome|Part B: VX-371 in HS + IVA|Participants who received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390537|NCT02871778|OG001|Outcome|Part B: HS + IVA|Participants who received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11197632|NCT02172755|FG000|Participant Flow|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11390538|NCT02871778|OG002|Outcome|Part B: VX-371 + IVA|Participants who received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390539|NCT02871778|OG003|Outcome|Part B: Placebo + IVA|Participants who received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390540|NCT02871778|OG000|Outcome|Part B: VX-371 in HS + Ivacaftor|Participants who received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390541|NCT02871778|OG001|Outcome|Part B: HS + Ivacaftor|Participants who received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390542|NCT02871778|OG002|Outcome|Part B: VX-371 + Ivacaftor|Participants who received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390543|NCT02871778|OG003|Outcome|Part B: Placebo + Ivacaftor|Participants who received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 to Day 85) in treatment period 2, continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 to Day 113) in treatment period 3 (Part B).
11390544|NCT02871778|EG000|Reported Event|Part A: VX-371 in HS|Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390545|NCT02871778|EG001|Reported Event|Part A: HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390546|NCT02871778|EG002|Reported Event|Part A: VX-371|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390547|NCT02871778|EG003|Reported Event|Part A: Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11390548|NCT02871778|EG004|Reported Event|Part B: VX-371 in HS + Ivacaftor|Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11197633|NCT02172755|FG001|Participant Flow|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
10965861|NCT00884312|EG001|Reported Event|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
11197634|NCT02172755|OG000|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11197635|NCT02172755|OG001|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11197636|NCT02172755|EG000|Reported Event|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11197637|NCT02172755|EG001|Reported Event|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
11197638|NCT02172820|BG000|Baseline|Financial Incentives|"Participants receive financial incentives for completing exercise sessions.~Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions."
11197639|NCT02172820|BG001|Baseline|Control|Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
11197640|NCT02172820|BG002|Baseline|Total|Total of all reporting groups
11197641|NCT02172820|FG000|Participant Flow|Financial Incentives|"Participants receive financial incentives for completing exercise sessions.~Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions."
11197642|NCT02172820|FG001|Participant Flow|Control|Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
11197643|NCT02172820|OG000|Outcome|Financial Incentives|"Participants receive financial incentives for completing exercise sessions.~Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions."
11197644|NCT02172820|OG001|Outcome|Control|Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
11197645|NCT02172820|EG000|Reported Event|Financial Incentives|"Participants receive financial incentives for completing exercise sessions.~Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.~39% fewer hospital contacts in the incentive condition (p=0.079)"
11197646|NCT02172820|EG001|Reported Event|Control|Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
11197647|NCT02172911|BG000|Baseline|Cohort I: INO-3112: Curative Intent|Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197648|NCT02172911|BG001|Baseline|Cohort II: INO-3112: Salvage Therapy|Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197649|NCT02172911|BG002|Baseline|Total|Total of all reporting groups
11197650|NCT02172911|FG000|Participant Flow|Cohort I: INO-3112: Curative Intent|Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197651|NCT02172911|FG001|Participant Flow|Cohort II: INO-3112: Salvage Therapy|Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197652|NCT02172911|OG000|Outcome|Cohort I: INO-3112: Curative Intent|Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11390549|NCT02871778|EG005|Reported Event|Part B: HS + Ivacaftor|Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390550|NCT02871778|EG006|Reported Event|Part B: VX-371 + Ivacaftor|Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390551|NCT02871778|EG007|Reported Event|Part B: Placebo + Ivacaftor|Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
11390552|NCT02769000|BG000|Baseline|Subjects 1-15|10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
11390553|NCT02769000|BG001|Baseline|Subjects 16 - 30|20 GY in 10 daily fractions: Subjects 16-30 20 GY in 10 daily fractions
11390554|NCT02769000|BG002|Baseline|Total|Total of all reporting groups
11390555|NCT02769000|FG000|Participant Flow|Subjects 1-15|10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
11390556|NCT02769000|FG001|Participant Flow|Subjects 16 - 30|20 GY in 10 daily fractions: Subjects 16-30 20 GY in 10 daily fractions
11390557|NCT02769000|OG000|Outcome|Subjects 1-15|10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
11390558|NCT02769000|EG000|Reported Event|Subjects 1-15|10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
11390559|NCT02756208|BG000|Baseline|300 ug FLSC Vaccine|Highest dose vaccine group
11390560|NCT02756208|BG001|Baseline|150 ug FLSC Vaccine|Middle dose vaccine group
11390561|NCT02756208|BG002|Baseline|75 ug FLSC Vaccine|Lowest dose vaccine group
11390562|NCT02756208|BG003|Baseline|Placebo|Placebo control group
11390563|NCT02756208|BG004|Baseline|Total|Total of all reporting groups
11390564|NCT02756208|FG000|Participant Flow|300 ug FLSC Vaccine|Highest dose vaccine group
11390565|NCT02756208|FG001|Participant Flow|150 ug FLSC Vaccine|Middle dose vaccine group
11390566|NCT02756208|FG002|Participant Flow|75 ug FLSC Vaccine|Lowest dose vaccine group
11390567|NCT02756208|FG003|Participant Flow|Placebo|Placebo control group
11390568|NCT02756208|OG000|Outcome|300 ug FLSC Vaccine|Highest dose vaccine group
11390569|NCT02756208|OG001|Outcome|150 ug FLSC Vaccine|Middle dose vaccine group
11390570|NCT02756208|OG002|Outcome|75 ug FLSC Vaccine|Lowest dose vaccine group
11390571|NCT02756208|OG003|Outcome|Placebo|Placebo control group
11390572|NCT02756208|EG000|Reported Event|300 ug FLSC Vaccine|Highest dose vaccine group
11390573|NCT02756208|EG001|Reported Event|150 ug FLSC Vaccine|Middle dose vaccine group
11390574|NCT02756208|EG002|Reported Event|75 ug FLSC Vaccine|Lowest dose vaccine group
11390575|NCT02756208|EG003|Reported Event|Placebo|Control group
11390576|NCT02149121|BG000|Baseline|CT-P10 (Main Study Period)|This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390577|NCT02149121|BG001|Baseline|Rituxan (Main Study Period)|This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390578|NCT02149121|BG002|Baseline|MabThera (Main Study Period)|This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390579|NCT02149121|BG003|Baseline|CT-P10/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390580|NCT02149121|BG004|Baseline|Rituxan/Rituxan (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
10965862|NCT00884325|BG000|Baseline|Subjects Receiving Xyzal|
10965863|NCT00884325|BG001|Baseline|Subjects Receiving Placebo|
11197653|NCT02172911|OG001|Outcome|Cohort II: INO-3112: Salvage Therapy|Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197654|NCT02172911|EG000|Reported Event|Cohort I: INO-3112: Curative Intent|Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197655|NCT02172911|EG001|Reported Event|Cohort II: INO-3112: Salvage Therapy|Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
11197656|NCT02172950|BG000|Baseline|Previously Treated Patients (PTPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197657|NCT02172950|BG001|Baseline|Previously Untreated Patients (PUPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197658|NCT02172950|BG002|Baseline|Total|Total of all reporting groups
11197659|NCT02172950|FG000|Participant Flow|Previously Treated Patients (PTPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197660|NCT02172950|FG001|Participant Flow|Previously Untreated Patients (PUPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197661|NCT02172950|OG000|Outcome|CSL627: Previously Treated Patients (PTPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197662|NCT02172950|OG000|Outcome|CSL627: Previously Untreated Patients (PUPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197663|NCT02172950|OG001|Outcome|CSL627: Previously Untreated Patients (PUPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197664|NCT02172950|EG000|Reported Event|CSL627: Previously Treated Patients (PTPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197665|NCT02172950|EG001|Reported Event|CSL627: Previously Untreated Patients (PUPs)|"The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.~rVIII-SingleChain: Recombinant single-chain coagulation factor VIII"
11197666|NCT02173054|BG000|Baseline|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11197667|NCT02173054|BG001|Baseline|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
10965864|NCT00884325|BG002|Baseline|Total|Total of all reporting groups
11390581|NCT02149121|BG005|Baseline|Rituxan/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390582|NCT02149121|BG006|Baseline|MabThera/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390583|NCT02149121|BG007|Baseline|Total|Total of all reporting groups
11390584|NCT02149121|FG000|Participant Flow|CT-P10 (Main Study Period)|This group received 1000mg rituximab (CT-P10; experimental drug) by intravenous (IV) infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, Methotrexate (MTX) (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390585|NCT02149121|FG001|Participant Flow|Rituxan (Main Study Period)|This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390586|NCT02149121|FG002|Participant Flow|MabThera (Main Study Period)|This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390587|NCT02149121|FG003|Participant Flow|CT-P10/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390588|NCT02149121|FG004|Participant Flow|Rituxan/Rituxan (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390589|NCT02149121|FG005|Participant Flow|Rituxan/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390590|NCT02149121|FG006|Participant Flow|MabThera/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US-licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
10800132|NCT02527434|OG001|Outcome|TNBC - COMBO|Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
11390591|NCT02149121|OG000|Outcome|CT-P10 (Main Study Period)|This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390592|NCT02149121|OG001|Outcome|Rituxan (Main Study Period)|This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390593|NCT02149121|OG002|Outcome|MabThera (Main Study Period)|This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390594|NCT02149121|OG001|Outcome|Rituxan (Main Study Period)|This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered..
11390595|NCT02149121|OG001|Outcome|Reference Products (Main Study Period)|Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390596|NCT02149121|OG003|Outcome|Reference Products (Main Study Period)|"Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and~1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered."
11390597|NCT02149121|OG000|Outcome|CT-P10/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (CT-P10; experimental drug) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390598|NCT02149121|OG001|Outcome|Rituxan/Rituxan (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/Rituxan group and received 1000mg rituximab (Rituxan; US licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390599|NCT02149121|OG002|Outcome|Rituxan/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group is for participants who were assigned as Rituxan/CT-P10 group and received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390600|NCT02149121|OG003|Outcome|MabThera/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course in the Extension Study Period followed by 1000mg rituximab (Rituxan; US licensed reference product) infusions in the Main Study Period. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390601|NCT02149121|OG003|Outcome|Reference Products (Main Study Period)|"Reference products group: The combined Rituxan and MabThera groups. This group received 1000mg rituximab (Rituxan and MabThera) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and~1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX(7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered."
10965865|NCT00884325|FG000|Participant Flow|Subjects Receiving Xyzal|one tablet, 5 mg, taken orally at night for 28 days
11390602|NCT02149121|OG000|Outcome|CT-P10 (Main Study Period)|This group received 1000mg rituximab (CT-P10; experimental drug) by IV) infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390603|NCT02149121|EG000|Reported Event|CT-P10 (Main Study Period)|This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390604|NCT02149121|EG001|Reported Event|Rituxan (Main Study Period)|This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390605|NCT02149121|EG002|Reported Event|MabThera (Main Study Period)|This group received 1000mg rituximab (MabThera; EU-approved reference product) by IV infusion. Each participant received up to 3 treatment courses (2 treatment courses in the Main Study Period, and 1 additional treatment course in the Extension Study Period), if they met predefined eligibility criteria. Each course consisted of 2 infusions with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390606|NCT02149121|EG003|Reported Event|CT-P10/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive CT-P10 with their first infusion in the Main Study Period, were considered as CT-P10/CT-P10 group and maintained CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10; experimental drug) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390607|NCT02149121|EG004|Reported Event|Rituxan/Rituxan (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (Rituxan; US-licensed reference product) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390608|NCT02149121|EG005|Reported Event|Rituxan/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive Rituxan with their first infusion in the Main Study Period, were randomized in a 1:1 ratio to Rituxan/Rituxan group and Rituxan/CT-P10 group at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390609|NCT02149121|EG006|Reported Event|MabThera/CT-P10 (Extension Study Period)|For the Extension Study Period, participants, who were assigned to receive MabThera with their first infusion in the Main Study Period, were considered as MabThera/CT-P10 group and received CT-P10 for the treatment course of the Extension Study Period at Extension Week 0. This group received 1000mg rituximab (CT-P10) by IV infusion with a 2-week interval between the first and second infusions of a 24-week course. Throughout the study, MTX (7.5-25 mg/week orally or parenterally) and folic acid (≥ 5 mg/week) were coadministered.
11390610|NCT01889186|BG000|Baseline|Main Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390611|NCT01889186|BG001|Baseline|Safety Expansion Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
10965866|NCT00884325|FG001|Participant Flow|Subjects Receiving Placebo|one tablet taken orally at night for 28 days
11390612|NCT01889186|BG002|Baseline|Total|Total of all reporting groups
11390613|NCT01889186|FG000|Participant Flow|Main Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390614|NCT01889186|FG001|Participant Flow|Safety Expansion Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390615|NCT01889186|OG000|Outcome|Main Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390616|NCT01889186|OG000|Outcome|Safety Expansion Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
10965867|NCT00884325|OG000|Outcome|Subjects Receiving Xyzal|
10965868|NCT00884325|OG001|Outcome|Subjects Receiving Placebo|
10965869|NCT00884325|EG000|Reported Event|Subjects Receiving Xyzal|
10965870|NCT00884325|EG001|Reported Event|Subjects Receiving Placebo|
11390617|NCT01889186|OG001|Outcome|Safety Expansion Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390618|NCT01889186|OG001|Outcome|All Treated Participants|Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, the starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390619|NCT01889186|EG000|Reported Event|Main Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390620|NCT01889186|EG001|Reported Event|Safety Expansion Cohort|Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
11390621|NCT01850004|BG000|Baseline|Total|Off-treatment and On-treatment after restarting Dasatinib
11390622|NCT01850004|FG000|Participant Flow|Total|Off treatment and On treatment after restarting Dasatinib
11390623|NCT01850004|OG000|Outcome|Total|All evaluable participants
11390624|NCT01850004|OG000|Outcome|Total|All Evaluable Subjects
11390625|NCT01850004|EG000|Reported Event|Dasatinib|All evaluable participants
11390626|NCT01510184|BG000|Baseline|Zevalin|Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).
11390627|NCT01510184|BG001|Baseline|Observation|Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
11390628|NCT01510184|BG002|Baseline|Total|Total of all reporting groups
11390629|NCT01510184|FG000|Participant Flow|Zevalin|Participants received rituximab 250 milligram per meter square (mg/m^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter [μL] to 149,000/μL).
11390630|NCT01510184|FG001|Participant Flow|Observation|Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
11390631|NCT01510184|OG000|Outcome|Zevalin|Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).
10965871|NCT00884377|BG000|Baseline|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
11390632|NCT01510184|OG001|Outcome|Observation|Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
11390633|NCT01510184|EG000|Reported Event|Zevalin|Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).
11390634|NCT01510184|EG001|Reported Event|Observation|Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
11390635|NCT01471444|BG000|Baseline|Arm A (Flu+Bu)|Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0.
11390636|NCT01471444|BG001|Baseline|Arm B (Flu+Clo+Bu)|FlFludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0.
11390637|NCT01471444|BG002|Baseline|Total|Total of all reporting groups
11390638|NCT01471444|FG000|Participant Flow|Arm A (Flu+Bu)|Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0.
11390639|NCT01471444|FG001|Participant Flow|Arm B (Flu+Clo+Bu)|Fludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0.
11390640|NCT01471444|OG000|Outcome|Arm A (Flu+Bu)|Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0.
11390641|NCT01471444|OG001|Outcome|Arm B (Flu+Clo+Bu)|Fludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0.
11390642|NCT01471444|OG000|Outcome|Arm A (Flu+Bu)|Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0..
11390643|NCT01471444|EG000|Reported Event|Arm A (Flu+Bu)|Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0.
11390644|NCT01471444|EG001|Reported Event|Arm B (Flu+Clo+Bu)|Fludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0.
11390645|NCT00545766|BG000|Baseline|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
11390646|NCT00545766|FG000|Participant Flow|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
11390647|NCT00545766|OG000|Outcome|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
11390648|NCT00545766|EG000|Reported Event|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
11390649|NCT04101890|BG000|Baseline|Routine Diaper Care Followed by Diaper Care With Theraworx|"Participants continue their typical diaper care for 4 weeks followed immediately by 4 weeks of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.~Diaper care with Theraworx: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes"
11390650|NCT04101890|FG000|Participant Flow|Routine Diaper Care Followed by Diaper Care With Theraworx|Participants continue their typical diaper care for a period of 4 weeks. This is directly followed by 4 weeks of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size).
11390651|NCT04101890|OG000|Outcome|Routine Diaper Care Followed by Diaper Care With Theraworx|Participants continue their typical diaper care x4 weeks, immediately followed by a 4 week period of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.
11390652|NCT04101890|OG000|Outcome|Routine Diaper Care Followed by Diaper Care With Theraworx|Participants continued their typical diaper care for 4 weeks immediately followed by 4 weeks of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During the second period, participants applied a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size).
11390653|NCT04101890|EG000|Reported Event|Diaper Care With Theraworx|"Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.~Diaper care with Theraworx: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes"
11390654|NCT04101890|EG001|Reported Event|Routine Diaper Care|Participants continue their typical diaper care.
11390655|NCT03993314|BG000|Baseline|Bupivacaine|"1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)~Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural"
11390656|NCT03993314|BG001|Baseline|Chloroprocaine|"5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)~Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural"
11390657|NCT03993314|BG002|Baseline|Total|Total of all reporting groups
11390658|NCT03993314|FG000|Participant Flow|Bupivacaine|"1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)~Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural"
11390659|NCT03993314|FG001|Participant Flow|Chloroprocaine|"5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)~Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural"
11390660|NCT03993314|OG000|Outcome|Bupivacaine|"1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)~Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural"
11197668|NCT02173054|BG002|Baseline|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390661|NCT03993314|OG001|Outcome|Chloroprocaine|"5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)~Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural"
11197669|NCT02173054|BG003|Baseline|Total|Total of all reporting groups
11390662|NCT03993314|EG000|Reported Event|Bupivacaine|"1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)~Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural"
11390663|NCT03993314|EG001|Reported Event|Chloroprocaine|"5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)~Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural"
11390664|NCT03874351|BG000|Baseline|Active tDCS|"The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390665|NCT03874351|BG001|Baseline|Sham tDCS|"Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390666|NCT03874351|BG002|Baseline|Total|Total of all reporting groups
11390667|NCT03874351|FG000|Participant Flow|Active tDCS|"The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390668|NCT03874351|FG001|Participant Flow|Sham tDCS|"Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390669|NCT03874351|OG000|Outcome|Active tDCS|"The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390670|NCT03874351|OG001|Outcome|Sham tDCS|"Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390671|NCT03874351|EG000|Reported Event|Active tDCS|"The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390672|NCT03874351|EG001|Reported Event|Sham tDCS|"Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.~non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right."
11390673|NCT03856359|BG000|Baseline|Rifaximin|"rifaximin 550 milligrams (mg) orally twice daily for 3 months~Rifaximin 550 milligrams (MG): Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease."
11390674|NCT03856359|FG000|Participant Flow|Rifaximin|"rifaximin 550 milligrams (mg) orally twice daily for 3 months~Rifaximin 550 milligrams (MG): Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease."
11390675|NCT03856359|OG000|Outcome|Rifaximin|"rifaximin 550 milligrams (mg) orally twice daily for 3 months~Rifaximin 550 milligrams (MG): Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease."
11390676|NCT03856359|EG000|Reported Event|Rifaximin|"rifaximin 550 milligrams (mg) orally twice daily for 3 months~Rifaximin 550 milligrams (MG): Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease."
11390677|NCT03769519|BG000|Baseline|Control (Group 1)|This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.
11390678|NCT03769519|BG001|Baseline|ARICA Intervention (Group 2)|"This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.~ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package."
11390679|NCT03769519|BG002|Baseline|Total|Total of all reporting groups
11197670|NCT02173054|FG000|Participant Flow|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390680|NCT03769519|FG000|Participant Flow|Control (Group 1)|This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.
11390681|NCT03769519|FG001|Participant Flow|ARICA Intervention (Group 2)|"This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.~ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package."
11390682|NCT03769519|OG000|Outcome|Control (Group 1)|This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.
11197671|NCT02173054|FG001|Participant Flow|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390683|NCT03769519|OG001|Outcome|ARICA Intervention (Group 2)|"This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.~ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package."
11390684|NCT03769519|EG000|Reported Event|Control (Group 1)|This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.
11390685|NCT03769519|EG001|Reported Event|ARICA Intervention (Group 2)|"This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.~ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package."
10965872|NCT00884377|BG001|Baseline|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
10965873|NCT00884377|BG002|Baseline|Total|Total of all reporting groups
10965874|NCT00884377|FG000|Participant Flow|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
10965875|NCT00884377|FG001|Participant Flow|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
10965876|NCT00884377|OG000|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
10965877|NCT00884377|OG001|Outcome|ThermoMed Device|ThermoMed device group
11197672|NCT02173054|FG002|Participant Flow|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11197673|NCT02173054|OG000|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11197674|NCT02173054|OG001|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390686|NCT03745651|BG000|Baseline|VC Period: Vehicle Cream BID|Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390687|NCT03745651|BG001|Baseline|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390688|NCT03745651|BG002|Baseline|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390689|NCT03745651|BG003|Baseline|Total|Total of all reporting groups
11390690|NCT03745651|FG000|Participant Flow|VC Period: Vehicle Cream BID|Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390691|NCT03745651|FG001|Participant Flow|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390692|NCT03745651|FG002|Participant Flow|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
10965878|NCT00884377|OG000|Outcome|Sodium Stibogluconate|Sodium Stibogluconate Groups
10965879|NCT00884377|OG001|Outcome|ThermoMed Treatment|ThermoMed Treatment Groups
10965880|NCT00884377|OG000|Outcome|Study Day 1: Sodium Stibogluconate|Day 1: Sodium Stibogluconate group
10965881|NCT00884377|OG001|Outcome|Study Day 10: Sodium Stibogluconate|Day 10: Sodium Stibogluconate group
10965882|NCT00884377|OG002|Outcome|Study Day 1: ThermoMed|Day 1: TherrmoMed group
10965883|NCT00884377|OG003|Outcome|Study Day 10: ThermoMed|Day 10: ThermoMed group
10965884|NCT00884377|EG000|Reported Event|Sodium Stibogluconate Intravenous|"20 mg/kg/day Sodium stibogluconate intravenous~Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days"
10965885|NCT00884377|EG001|Reported Event|ThermoMed Device|"ThermoMed device, single heat treatment at 50 degrees Celsius~ThermoMed: ThermoMed heat treatment device, one treatment"
10965886|NCT00884390|BG000|Baseline|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
11197675|NCT02173054|OG002|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390693|NCT03745651|FG003|Participant Flow|LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID|Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390694|NCT03745651|FG004|Participant Flow|LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID|Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390695|NCT03745651|FG005|Participant Flow|LTS Period: Ruxolitinib 0.75% Cream BID|Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390696|NCT03745651|FG006|Participant Flow|LTS Period: Ruxolitinib 1.5% Cream BID|Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390697|NCT03745651|OG000|Outcome|VC Period: Vehicle Cream BID|Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390698|NCT03745651|OG001|Outcome|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390699|NCT03745651|OG002|Outcome|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390700|NCT03745651|OG000|Outcome|VC Period: Vehicle Cream BID|Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390701|NCT03745651|OG000|Outcome|LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID|Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390702|NCT03745651|OG001|Outcome|LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID|Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390703|NCT03745651|OG002|Outcome|LTS Period: Ruxolitinib 0.75% Cream BID|Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390704|NCT03745651|OG003|Outcome|LTS Period: Ruxolitinib 1.5% Cream BID|Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390705|NCT03745651|OG000|Outcome|LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID|Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390706|NCT03745651|OG000|Outcome|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390707|NCT03745651|OG001|Outcome|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390708|NCT03745651|EG000|Reported Event|Vehicle Cream BID|Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.
10965887|NCT00884390|BG001|Baseline|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
10965888|NCT00884390|BG002|Baseline|Total|Total of all reporting groups
10965889|NCT00884390|FG000|Participant Flow|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
10965890|NCT00884390|FG001|Participant Flow|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
10965891|NCT00884390|OG000|Outcome|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
10965892|NCT00884390|OG001|Outcome|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
11390709|NCT03745651|EG001|Reported Event|Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390710|NCT03745651|EG002|Reported Event|Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390711|NCT03745638|BG000|Baseline|VC Period: Vehicle Cream BID|Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390712|NCT03745638|BG001|Baseline|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390713|NCT03745638|BG002|Baseline|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390714|NCT03745638|BG003|Baseline|Total|Total of all reporting groups
11390715|NCT03745638|FG000|Participant Flow|VC Period: Vehicle Cream BID|Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390716|NCT03745638|FG001|Participant Flow|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390717|NCT03745638|FG002|Participant Flow|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390718|NCT03745638|FG003|Participant Flow|LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID|Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11197676|NCT02173054|EG000|Reported Event|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11197677|NCT02173054|EG001|Reported Event|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11197678|NCT02173054|EG002|Reported Event|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
11390719|NCT03745638|FG004|Participant Flow|LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID|Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390720|NCT03745638|FG005|Participant Flow|LTS Period: Ruxolitinib 0.75% Cream|Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390721|NCT03745638|FG006|Participant Flow|LTS Period: Ruxolitinib 1.5% Cream|Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390722|NCT03745638|OG000|Outcome|VC Period: Vehicle Cream BID|Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390723|NCT03745638|OG001|Outcome|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390724|NCT03745638|OG002|Outcome|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390725|NCT03745638|OG000|Outcome|LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID|Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390726|NCT03745638|OG001|Outcome|LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID|Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
10965893|NCT00884390|OG000|Outcome|Annualized Bleed Rate|ABR by regimen at baseline is summarized for all participants for on-demand regimen, preventive regimen and prophylaxis regimen, respectively
11390727|NCT03745638|OG002|Outcome|LTS Period: Ruxolitinib 0.75% Cream|Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390728|NCT03745638|OG003|Outcome|LTS Period: Ruxolitinib 1.5% Cream|Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
11390729|NCT03745638|OG000|Outcome|VC Period: Vehicle Cream BID|Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
11390730|NCT03745638|OG001|Outcome|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
11390731|NCT03745638|OG002|Outcome|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.
11390732|NCT03745638|OG000|Outcome|VC Period: Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390733|NCT03745638|OG001|Outcome|VC Period: Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390734|NCT03745638|EG000|Reported Event|Vehicle Cream BID|Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390735|NCT03745638|EG001|Reported Event|Ruxolitinib 0.75% Cream BID|Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390736|NCT03745638|EG002|Reported Event|Ruxolitinib 1.5% Cream BID|Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 52 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
11390737|NCT03715764|BG000|Baseline|Physical Therapy Assessment|"Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to.~Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care."
11390738|NCT03715764|BG001|Baseline|Physician Assessment|"Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician.~Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care."
11390739|NCT03715764|BG002|Baseline|Total|Total of all reporting groups
11390740|NCT03715764|FG000|Participant Flow|Physical Therapy Assessment|"Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to.~Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care."
10965894|NCT00884390|OG000|Outcome|First Infusion Per Bleed|Includes the first infusion for an associated bleeding episode
11390741|NCT03715764|FG001|Participant Flow|Physician Assessment|"Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician.~Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care."
11390742|NCT03715764|OG000|Outcome|Physical Therapy Assessment|"Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to.~Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care."
10965895|NCT00884390|OG000|Outcome|All Participants With Bleeds|Includes any infusion with an associated bleeding episode, regardless of the reason for treatment indicated on the case report form
11390743|NCT03715764|OG001|Outcome|Physician Assessment|"Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician.~Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care."
11390744|NCT03715764|EG000|Reported Event|Physical Therapy Assessment|"Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to.~Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care."
11390745|NCT03715764|EG001|Reported Event|Physician Assessment|"Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician.~Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care."
11390746|NCT03663855|BG000|Baseline|Cystinuria Patients|Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
11390747|NCT03663855|FG000|Participant Flow|Cystinuria Patients|Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
11390748|NCT03663855|OG000|Outcome|Cystinuria Patients|Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
11390749|NCT03663855|EG000|Reported Event|Cystinuria Patients|Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
11390750|NCT03654729|BG000|Baseline|PledOx (2 µmol/kg)|"Calmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (2 µmol/kg): Solution in 20 mL single dose glass vial"
11390751|NCT03654729|BG001|Baseline|PledOx (5 µmol/kg)|"Calmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (5 µmol/kg): Solution in 20 mL single dose glass vial"
11390752|NCT03654729|BG002|Baseline|Placebo|"Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.~Placebo: Solution in 20 mL single dose glass vial"
11390753|NCT03654729|BG003|Baseline|Total|Total of all reporting groups
11390754|NCT03654729|FG000|Participant Flow|PledOx (2 µmol/kg)|"Calmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (2 µmol/kg): Solution in 20 mL single dose glass vial"
11390755|NCT03654729|FG001|Participant Flow|PledOx (5 µmol/kg)|"Calmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (5 µmol/kg): Solution in 20 mL single dose glass vial"
11390756|NCT03654729|FG002|Participant Flow|Placebo|"Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.~Placebo: Solution in 20 mL single dose glass vial"
11390757|NCT03654729|OG000|Outcome|PledOx (2 µmol/kg)|"Calmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (2 µmol/kg): Solution in 20 mL single dose glass vial"
11390758|NCT03654729|OG001|Outcome|PledOx (5 µmol/kg)|"Calmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (5 µmol/kg): Solution in 20 mL single dose glass vial"
11390759|NCT03654729|OG002|Outcome|Placebo|"Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.~Placebo: Solution in 20 mL single dose glass vial"
11390760|NCT03654729|EG000|Reported Event|PledOx (2 µmol/kg)|"Calmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (2 µmol/kg): Solution in 20 mL single dose glass vial"
11390761|NCT03654729|EG001|Reported Event|PledOx (5 µmol/kg)|"Calmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.~Calmangafodipir (5 µmol/kg): Solution in 20 mL single dose glass vial"
10965896|NCT00884390|OG000|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
10965897|NCT00884390|OG000|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
11390762|NCT03654729|EG002|Reported Event|Placebo|"Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.~Placebo: Solution in 20 mL single dose glass vial"
11390763|NCT03531112|BG000|Baseline|Appetite Awareness Treatment + Lifestyle Modification|Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
11390764|NCT03531112|BG001|Baseline|Control|Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
11390765|NCT03531112|BG002|Baseline|Total|Total of all reporting groups
11390766|NCT03531112|FG000|Participant Flow|Appetite Awareness Treatment + Lifestyle Modification|Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM): The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
11390767|NCT03531112|FG001|Participant Flow|Control|Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
11390768|NCT03531112|OG000|Outcome|Appetite Awareness Treatment + Lifestyle Modification|Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
11390769|NCT03531112|OG001|Outcome|Control|Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
11390770|NCT03531112|EG000|Reported Event|Appetite Awareness Treatment + Lifestyle Modification|Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
11390771|NCT03531112|EG001|Reported Event|Control|Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
11390772|NCT03112902|BG000|Baseline|Effects of tACS During SWS- Standard/Nested 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a triple crossover: standard tACS, then nested tACS, then sham."
11390773|NCT03112902|BG001|Baseline|Effects of tACS During SWS- Standard/Nested 2|This is a triple crossover: nested tACS, then standard tACS, then sham.
11390774|NCT03112902|BG002|Baseline|Effects of tACS During SWS- Standard/Nested 3|This is a triple crossover: sham, then nested tACS, then standard tACS.
11390775|NCT03112902|BG003|Baseline|Effects of tACS During SWS- Standard/Nested 4|This is a triple crossover: sham, then standard tACS, then nested tACS
11390776|NCT03112902|BG004|Baseline|Effects of tACS During SWS- Standard/Nested 5|This is a triple crossover: nested tACS, then sham, then standard tACS
11390777|NCT03112902|BG005|Baseline|Effects of tACS During SWS- Standard/Nested 6|This is a triple crossover: nested tACS, then standard tACS, then sham.
11390778|NCT03112902|BG006|Baseline|Effects of tACS During SWS- Older Adults Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover: standard tACS, then sham."
11390779|NCT03112902|BG007|Baseline|Effects of tACS During SWS- Older Adults Active 2|This is a crossover: sham, then tACS.
11390780|NCT03112902|BG008|Baseline|Effects of tACS During SWS- MCI Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover: standard tACS, then sham."
11390781|NCT03112902|BG009|Baseline|Effects of tACS During SWS- MCI Active 2|This is a crossover: sham, then tACS.
11390782|NCT03112902|BG010|Baseline|Total|Total of all reporting groups
11390783|NCT03112902|FG000|Participant Flow|Effects of tACS During SWS- Standard/Nested 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a triple crossover study design: standard tACS first, then nested tACS, then sham."
11390784|NCT03112902|FG001|Participant Flow|Effects of tACS During SWS- Standard/Nested 2|This is a triple crossover study design: standard tACS first, then sham, then nested tACS.
11390785|NCT03112902|FG002|Participant Flow|Effects of tACS During SWS- Standard/Nested 3|This is a triple crossover study design: sham first, then nested tACS, then standard tACS.
11390786|NCT03112902|FG003|Participant Flow|Effects of tACS During SWS- Standard/Nested 4|This is a triple crossover study design: sham first, then standard tACS, then nested tACS.
11390787|NCT03112902|FG004|Participant Flow|Effects of tACS During SWS- Standard/Nested 5|This is a triple crossover study design: nested tACS first, then sham, then standard tACS.
11390788|NCT03112902|FG005|Participant Flow|Effects of tACS During SWS- Standard/Nested 6|This is a triple crossover study design: nested tACS first, then standard tACS, then sham.
11390789|NCT03112902|FG006|Participant Flow|Effects of tACS During SWS- Older Adults Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover study design: standard tACS first, then sham."
11197679|NCT02173158|BG000|Baseline|Lomitapide|Maximum tolerated dose of lomitapide (up to 60mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.
11197680|NCT02173158|FG000|Participant Flow|Lomitapide|Maximum tolerated dose of lomitapide (up to 60mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.
11390790|NCT03112902|FG007|Participant Flow|Effects of tACS During SWS- Older Adults Active 2|This is a crossover study design: sham first, then standard tACS.
11390791|NCT03112902|FG008|Participant Flow|Effects of tACS During SWS- MCI Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover study design: standard tACS first, then sham."
11390792|NCT03112902|FG009|Participant Flow|Effects of tACS During SWS- MCI Active 2|This is a crossover study design: sham first, then standard tACS.
11390793|NCT03112902|OG000|Outcome|Effects of tACS During SWS- Standard|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This was part of a triple crossover"
11390794|NCT03112902|OG001|Outcome|Effects of tACS During SWS- Nested|This was part of a triple crossover
11390795|NCT03112902|OG002|Outcome|Effects of tACS During SWS- Older Adults Active|"This is a cross-over with a sham control condition~Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture."
10965898|NCT00884390|OG000|Outcome|Participants Following a Non-prophylaxis Regimen at Baseline|All enrolled participants following an on-demand or preventive regimen at baseline
11197681|NCT02173158|OG000|Outcome|Lomitapide|Maximum tolerated dose of lomitapide (up to 60mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.
11390796|NCT03112902|OG003|Outcome|Effects of tACS During SWS- MCI Active|"This is a cross-over with a sham control condition~Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture."
11390797|NCT03112902|EG000|Reported Event|Effects of tACS During SWS- Standard/Nested 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a triple crossover: standard tACS, then nested, then sham"
11390798|NCT03112902|EG001|Reported Event|Effects of tACS During SWS- Standard/Nested 2|This is a triple crossover: standard tACS, then sham, then nested tACS
11390799|NCT03112902|EG002|Reported Event|Effects of tACS During SWS- Standard/Nested 3|This is a triple crossover: sham, then nested tACS, then standard tACS,
11390800|NCT03112902|EG003|Reported Event|Effects of tACS During SWS- Standard/Nested 4|This is a triple crossover: sham, then standard tACS, then nested tACS,
11390801|NCT03112902|EG004|Reported Event|Effects of tACS During SWS- Standard/Nested 5|This is a triple crossover: nested tACS, then sham, then standard tACS,
11390802|NCT03112902|EG005|Reported Event|Effects of tACS During SWS- Standard/Nested 6|This is a triple crossover: nested tACS, then standard tACS then sham.
11390803|NCT03112902|EG006|Reported Event|Effects of tACS During SWS- Older Adults Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover: standard tACS, then sham"
11390804|NCT03112902|EG007|Reported Event|Effects of tACS During SWS- Older Adults Active 2|This is a crossover: sham and then standard tACS
11390805|NCT03112902|EG008|Reported Event|Effects of tACS During SWS- MCI Active 1|"Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.~This is a crossover: standard tACS, then sham"
11390806|NCT03112902|EG009|Reported Event|Effects of tACS During SWS- MCI Active 2|This is a crossover: sham and then standard tACS
11390807|NCT02976038|BG000|Baseline|Elamipretide|"Open-label once daily subcutaneous injection of 40mg elamipretide~elamipretide: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD."
11390808|NCT02976038|FG000|Participant Flow|Elamipretide|"Open-label once daily subcutaneous injection of 40mg elamipretide~elamipretide: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD."
11197682|NCT02173158|EG000|Reported Event|Efficacy Phase|Baseline to Week 26
11390809|NCT02976038|OG000|Outcome|Elamipretide|"Open-label once daily subcutaneous injection of 40mg elamipretide~elamipretide: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD."
10965899|NCT00884390|OG001|Outcome|Participants Following a Prophylaxis Regimen at Baseline|All enrolled participants following a prophylaxis regimen at baseline
10965900|NCT00884390|OG000|Outcome|All Participants With at Least One Bleed|All enrolled participants with at least one bleed.
10965901|NCT00884390|OG000|Outcome|All Participants With at Least One Prophylaxis Infusion|All enrolled participants with at least one prophylaxis infusion
10965902|NCT00884390|EG000|Reported Event|All Participants|The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
10965903|NCT00884585|BG000|Baseline|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
10965904|NCT00884585|BG001|Baseline|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
10965905|NCT00884585|BG002|Baseline|Total|Total of all reporting groups
10965906|NCT00884585|FG000|Participant Flow|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
10965907|NCT00884585|FG001|Participant Flow|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
10965908|NCT00884585|OG000|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
10965909|NCT00884585|OG001|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
10965910|NCT00884585|EG000|Reported Event|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
10965911|NCT00884585|EG001|Reported Event|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
10965912|NCT00884611|BG000|Baseline|Predictive Suspend|Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.
11197683|NCT02173158|EG001|Reported Event|Safety Phase|Week 26 to Week 56
11390810|NCT02976038|OG000|Outcome|No Problem|"Participant reports symptom is no problem"
11390811|NCT02976038|OG001|Outcome|Slight Problem|"Participant reports symptom is a slight problem"
11390812|NCT02976038|OG002|Outcome|Moderate Problem|"Participant reports symptom is a moderate problem"
11390813|NCT02976038|OG003|Outcome|Severe Problem|"Participant reports symptom is a severe problem"
11390814|NCT02976038|OG004|Outcome|Extreme Problem|"Participant reports symptom is an extreme problem"
11390815|NCT02976038|OG000|Outcome|Excellent|Number of participants the Physician rated current disease status as Excellent
11390816|NCT02976038|OG001|Outcome|Fair|Number of participants Physician rated current disease status as Fair
11197684|NCT02173392|BG000|Baseline|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197685|NCT02173392|BG001|Baseline|(Treatment B Days 1-28 + Treatment 8 Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11390817|NCT02976038|OG002|Outcome|Good|Number of participants Physician rated current disease status as Good
11390818|NCT02976038|OG003|Outcome|Poor|Number of participants Physician rated current disease status as Poor
11390819|NCT02976038|OG004|Outcome|Very Good|Number of participants the Physician rated current disease status as Very Good
11390820|NCT02976038|EG000|Reported Event|Elamipretide|"Open-label once daily subcutaneous injection of 40mg elamipretide~elamipretide: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD."
11390821|NCT02631070|BG000|Baseline|Luspatercept|Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
11390822|NCT02631070|BG001|Baseline|Placebo|Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
11390823|NCT02631070|BG002|Baseline|Total|Total of all reporting groups
11390824|NCT02631070|FG000|Participant Flow|Luspatercept|Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
11390825|NCT02631070|FG001|Participant Flow|Placebo|Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
11390826|NCT02631070|OG000|Outcome|Luspatercept|Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
11390827|NCT02631070|OG001|Outcome|Placebo|Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
11390828|NCT02631070|EG000|Reported Event|Luspatercept|Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
11390829|NCT02631070|EG001|Reported Event|Placebo|Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
11390830|NCT02281955|BG000|Baseline|De-escalated Radiation and Chemotherapy|All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
11197686|NCT02173392|BG002|Baseline|Total|Total of all reporting groups
11197687|NCT02173392|FG000|Participant Flow|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11390831|NCT02281955|FG000|Participant Flow|De-escalated Radiation and Chemotherapy|All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
11390832|NCT02281955|OG000|Outcome|De-escalated Radiation and Chemotherapy|All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
11197688|NCT02173392|FG001|Participant Flow|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197689|NCT02173392|OG000|Outcome|Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197690|NCT02173392|OG001|Outcome|Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197691|NCT02173392|OG000|Outcome|Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197692|NCT02173392|OG001|Outcome|Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197693|NCT02173392|EG000|Reported Event|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197694|NCT02173392|EG001|Reported Event|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)~Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
11197695|NCT02173522|BG000|Baseline|Prostate Artery Embolization (PAE)|"10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).~Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres."
11197696|NCT02173522|BG001|Baseline|Control|10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center.
11197697|NCT02173522|BG002|Baseline|Total|Total of all reporting groups
11197698|NCT02173522|FG000|Participant Flow|Prostate Artery Embolization (PAE)|"10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).~Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres."
11197699|NCT02173522|FG001|Participant Flow|Control|10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center.
11197700|NCT02173522|OG000|Outcome|Prostate Artery Embolization (PAE)|"10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).~Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres."
11197701|NCT02173522|EG000|Reported Event|Prostate Artery Embolization (PAE)|"10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).~Prostate artery embolization (PAE): Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres."
11197702|NCT02173535|BG000|Baseline|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197703|NCT02173535|BG001|Baseline|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197704|NCT02173535|BG002|Baseline|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197705|NCT02173535|BG003|Baseline|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197706|NCT02173535|BG004|Baseline|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197707|NCT02173535|BG005|Baseline|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197708|NCT02173535|BG006|Baseline|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197709|NCT02173535|BG007|Baseline|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197710|NCT02173535|BG008|Baseline|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197711|NCT02173535|BG009|Baseline|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197712|NCT02173535|BG010|Baseline|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197713|NCT02173535|BG011|Baseline|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197714|NCT02173535|BG012|Baseline|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197715|NCT02173535|BG013|Baseline|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197716|NCT02173535|BG014|Baseline|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197717|NCT02173535|BG015|Baseline|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11390833|NCT02281955|EG000|Reported Event|De-escalated Radiation and Chemotherapy|All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
11390834|NCT02202434|BG000|Baseline|Lotus Valve System - Randomized|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390835|NCT02202434|BG001|Baseline|CoreValve TAVR System - Randomized|"Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System~CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390836|NCT02202434|BG002|Baseline|Lotus Valve System - Single-arm Roll-in Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390837|NCT02202434|BG003|Baseline|Lotus Valve System - Single-arm Continued Access Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390838|NCT02202434|BG004|Baseline|Total|Total of all reporting groups
11390839|NCT02202434|FG000|Participant Flow|Lotus Valve System - Randomized|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390840|NCT02202434|FG001|Participant Flow|CoreValve TAVR System - Randomized|"Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System~CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390841|NCT02202434|FG002|Participant Flow|Lotus Valve System - Single-arm Roll-in Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390842|NCT02202434|FG003|Participant Flow|Lotus Valve System - Single-arm Continued Access Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390843|NCT02202434|OG000|Outcome|Lotus Valve System - Randomized|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390844|NCT02202434|OG001|Outcome|CoreValve TAVR System - Randomized|"Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System~CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390845|NCT02202434|OG002|Outcome|Lotus Valve System - Single-arm Roll-in Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390846|NCT02202434|OG003|Outcome|Lotus Valve System - Single-arm Continued Access Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390847|NCT02202434|EG000|Reported Event|Lotus Valve System - Randomized|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390848|NCT02202434|EG001|Reported Event|CoreValve TAVR System - Randomized|"Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System~CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390849|NCT02202434|EG002|Reported Event|Lotus Valve System - Single-arm Roll-in Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11390850|NCT02202434|EG003|Reported Event|Lotus Valve System - Single-arm Continued Access Cohort|"Transcatheter aortic valve replacement (TAVR) with Lotus Valve System~Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)"
11197718|NCT02173535|BG016|Baseline|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11390851|NCT01727011|BG000|Baseline|IPAS|"Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction~IPAS"
11390852|NCT01727011|FG000|Participant Flow|Irradiation and Accelerated Partial Breast (IPAS)|"Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction~IPAS"
11390853|NCT01727011|OG000|Outcome|IPAS|"Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction~IPAS"
11390854|NCT01727011|EG000|Reported Event|IPAS|"Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction~IPAS"
11390855|NCT01230242|BG000|Baseline|Mirena IUD Placement Immediately Post-delivery|Subjects to have Mirena IUD Placement Immediately Post-delivery
11390856|NCT01230242|FG000|Participant Flow|Mirena IUD Placement Immediately Post-delivery|Subjects to have Mirena IUD Placement Immediately Post-delivery
11197719|NCT02173535|BG017|Baseline|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11390857|NCT01230242|OG000|Outcome|Mirena IUD Placement Immediately Post-delivery|"Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.~Levonorgestrel Intrauterine Device: levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol"
11390858|NCT01230242|EG000|Reported Event|Mirena IUD Placement Immediately Post-delivery|Subjects to have Mirena IUD Placement Immediately Post-delivery
11390859|NCT00983437|BG000|Baseline|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
11390860|NCT00983437|FG000|Participant Flow|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
11390861|NCT00983437|OG000|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
11390862|NCT00983437|EG000|Reported Event|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
11390863|NCT00965757|BG000|Baseline|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
11390864|NCT00965757|BG001|Baseline|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
11390865|NCT00965757|BG002|Baseline|Total|Total of all reporting groups
11390866|NCT00965757|FG000|Participant Flow|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
11390867|NCT00965757|FG001|Participant Flow|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
11390868|NCT00965757|FG002|Participant Flow|T-614 (Extension, 29-52 Weeks)|T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
11390869|NCT00965757|FG003|Participant Flow|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
11390870|NCT00965757|OG000|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
11390871|NCT00965757|OG001|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
11390872|NCT00965757|OG002|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
11390873|NCT00965757|EG000|Reported Event|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
11390874|NCT00965757|EG001|Reported Event|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
11390875|NCT00965757|EG002|Reported Event|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
11390876|NCT00928447|BG000|Baseline|Overall Study (rHuPH20 and Placebo)|Participant's upper back was divided into two equal spaces and received Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening, was applied to the upper space at Day 1. After 48 hours (Day 3), the patches were removed and the reactions were graded on the ICDRG scale. A 0.25 mL intradermal injection containing rHuPH20 (3,000 U) or placebo (excipient) was administered once daily for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space was injected intradermally with 0.25 mL of study material drug rHuPH20 (3,000 U) or placebo (excipient), in a randomly assigned 2:2 ratio at Day 1. Exactly ten minutes after the injections, patches with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening were applied to the injection sites. After 48 hours (Day 3), the patches were removed and the reactions graded on the ICDRG scale. As during pretreatment, a 0.25 mL intradermal injection containing rHuPH20 or placebo was then administered once daily for 5 days at the center of each area of reaction.
11390877|NCT00928447|FG000|Participant Flow|Overall Study (rHuPH20 and Placebo)|Participant's upper back was divided into two equal spaces and received Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening, was applied to the upper space at Day 1. After 48 hours (Day 3), the patches were removed and the reactions were graded on the ICDRG scale. A 0.25 milliliters (mL) intradermal injection containing rHuPH20 (3,000 units [U]) or placebo (excipient) was administered once daily for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space was injected intradermally with 0.25 mL of study material drug rHuPH20 (3,000 U) or placebo (excipient), in a randomly assigned 2:2 ratio at Day 1. Exactly ten minutes after the injections, patches with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening were applied to the injection sites. After 48 hours (Day 3), the patches were removed and the reactions graded on the ICDRG scale. As during pretreatment, a 0.25 mL intradermal injection containing rHuPH20 or placebo was then administered once daily for 5 days at the center of each area of reaction.
11390878|NCT00928447|OG000|Outcome|Overall Study (rHuPH20 and Placebo)|Participant's upper back was divided into two equal spaces and received Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening, was applied to the upper space at Day 1. After 48 hours (Day 3), the patches were removed and the reactions were graded on the ICDRG scale. A 0.25 mL intradermal injection containing rHuPH20 (3,000 U) or placebo (excipient) was administered once daily for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space was injected intradermally with 0.25 mL of study material drug rHuPH20 (3,000 U) or placebo (excipient), in a randomly assigned 2:2 ratio at Day 1. Exactly ten minutes after the injections, patches with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening were applied to the injection sites. After 48 hours (Day 3), the patches were removed and the reactions graded on the ICDRG scale. As during pretreatment, a 0.25 mL intradermal injection containing rHuPH20 or placebo was then administered once daily for 5 days at the center of each area of reaction.
11390879|NCT00928447|EG000|Reported Event|Overall Study (rHuPH20 and Placebo)|Participant's upper back was divided into two equal spaces and received Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening, was applied to the upper space at Day 1. After 48 hours (Day 3), the patches were removed and the reactions were graded on the ICDRG scale. A 0.25 mL intradermal injection containing rHuPH20 (3,000 U) or placebo (excipient) was administered once daily for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space was injected intradermally with 0.25 mL of study material drug rHuPH20 (3,000 U) or placebo (excipient), in a randomly assigned 2:2 ratio at Day 1. Exactly ten minutes after the injections, patches with the nickel sulfate concentration (1, 2.5, or 5%) determined at screening were applied to the injection sites. After 48 hours (Day 3), the patches were removed and the reactions graded on the ICDRG scale. As during pretreatment, a 0.25 mL intradermal injection containing rHuPH20 or placebo was then administered once daily for 5 days at the center of each area of reaction.
11390880|NCT00893789|BG000|Baseline|Placebo|Oral placebo tablets, once daily (QD)
11390881|NCT00893789|BG001|Baseline|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
11390882|NCT00893789|BG002|Baseline|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
11390883|NCT00893789|BG003|Baseline|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
11390884|NCT00893789|BG004|Baseline|Total|Total of all reporting groups
11390885|NCT00893789|FG000|Participant Flow|Placebo|Oral placebo tablets, once daily (QD)
11390886|NCT00893789|FG001|Participant Flow|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
11390887|NCT00893789|FG002|Participant Flow|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
11390888|NCT00893789|FG003|Participant Flow|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
11390889|NCT00893789|OG000|Outcome|Placebo|Oral placebo tablets, once daily (QD)
11390890|NCT00893789|OG001|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
11390891|NCT00893789|OG002|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
11390892|NCT00893789|OG003|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
11390893|NCT00893789|EG000|Reported Event|Placebo|Oral placebo tablets, once daily (QD)
11390894|NCT00893789|EG001|Reported Event|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
11390895|NCT00893789|EG002|Reported Event|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
11390896|NCT00893789|EG003|Reported Event|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
10965913|NCT00884611|FG000|Participant Flow|Predictive Suspend|Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.
10800133|NCT02527434|OG002|Outcome|PDAC - COMBO|Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
11197720|NCT02173535|BG018|Baseline|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197721|NCT02173535|BG019|Baseline|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197722|NCT02173535|BG020|Baseline|Total|Total of all reporting groups
11197723|NCT02173535|FG000|Participant Flow|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197724|NCT02173535|FG001|Participant Flow|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197725|NCT02173535|FG002|Participant Flow|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197726|NCT02173535|FG003|Participant Flow|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197727|NCT02173535|FG004|Participant Flow|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197728|NCT02173535|FG005|Participant Flow|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197729|NCT02173535|FG006|Participant Flow|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197730|NCT02173535|FG007|Participant Flow|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197731|NCT02173535|FG008|Participant Flow|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197732|NCT02173535|FG009|Participant Flow|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197733|NCT02173535|FG010|Participant Flow|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197734|NCT02173535|FG011|Participant Flow|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197735|NCT02173535|FG012|Participant Flow|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197736|NCT02173535|FG013|Participant Flow|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197737|NCT02173535|FG014|Participant Flow|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197738|NCT02173535|FG015|Participant Flow|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197739|NCT02173535|FG016|Participant Flow|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197740|NCT02173535|FG017|Participant Flow|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197741|NCT02173535|FG018|Participant Flow|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197742|NCT02173535|FG019|Participant Flow|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197743|NCT02173535|OG000|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
11197744|NCT02173535|OG001|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
11197745|NCT02173535|OG002|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
11197746|NCT02173535|OG003|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
11197747|NCT02173535|OG004|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
11197748|NCT02173535|EG000|Reported Event|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197749|NCT02173535|EG001|Reported Event|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197750|NCT02173535|EG002|Reported Event|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197751|NCT02173535|EG003|Reported Event|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197752|NCT02173535|EG004|Reported Event|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197753|NCT02173535|EG005|Reported Event|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197754|NCT02173535|EG006|Reported Event|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197755|NCT02173535|EG007|Reported Event|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197756|NCT02173535|EG008|Reported Event|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197757|NCT02173535|EG009|Reported Event|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197758|NCT02173535|EG010|Reported Event|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197759|NCT02173535|EG011|Reported Event|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
10800134|NCT02527434|OG003|Outcome|UBC- MEDI|Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
11197760|NCT02173535|EG012|Reported Event|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197761|NCT02173535|EG013|Reported Event|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197762|NCT02173535|EG014|Reported Event|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197763|NCT02173535|EG015|Reported Event|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197764|NCT02173535|EG016|Reported Event|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197765|NCT02173535|EG017|Reported Event|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197766|NCT02173535|EG018|Reported Event|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197767|NCT02173535|EG019|Reported Event|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
11197768|NCT02173548|BG000|Baseline|Anakinra|"Anakinra 100 mg given subcutaneously once daily for 12 weeks~Anakinra"
11197769|NCT02173548|BG001|Baseline|Placebo|"Matching Placebo~Placebo"
11197770|NCT02173548|BG002|Baseline|Total|Total of all reporting groups
11197771|NCT02173548|FG000|Participant Flow|Anakinra|"Anakinra 100 mg given subcutaneously once daily for 12 weeks~Anakinra"
11197772|NCT02173548|FG001|Participant Flow|Placebo|"Matching Placebo~Placebo"
11197773|NCT02173548|OG000|Outcome|Anakinra|"Anakinra 100 mg given subcutaneously once daily for 12 weeks~Anakinra"
11197774|NCT02173548|OG001|Outcome|Placebo|"Matching Placebo~Placebo"
11197775|NCT02173548|EG000|Reported Event|Anakinra|"Anakinra 100 mg given subcutaneously once daily for 12 weeks~Anakinra"
11197776|NCT02173548|EG001|Reported Event|Placebo|"Matching Placebo~Placebo"
11197777|NCT02173704|BG000|Baseline|Bexsero + Routine Group|Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.
11197778|NCT02173704|BG001|Baseline|Routine Group|Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
11197779|NCT02173704|BG002|Baseline|Total|Total of all reporting groups
11197780|NCT02173704|FG000|Participant Flow|Bexsero + Routine Group|Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.
11197781|NCT02173704|FG001|Participant Flow|Routine Group|Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
11197782|NCT02173704|OG000|Outcome|Bexsero + Routine Group|Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.
11197783|NCT02173704|OG001|Outcome|Routine Group|Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
11197784|NCT02173704|EG000|Reported Event|Bexsero + Routine Group|Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.
11197785|NCT02173704|EG001|Reported Event|Routine Group|Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
11197786|NCT02173769|BG000|Baseline|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
11390897|NCT04349150|BG000|Baseline|Virtual Reality|"Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics~Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy"
11390898|NCT04349150|FG000|Participant Flow|Virtual Reality|"Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics~Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy"
11390899|NCT04349150|OG000|Outcome|Virtual Reality|"Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics~Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy"
11390900|NCT04349150|EG000|Reported Event|Virtual Reality|"Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics~Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy"
10800135|NCT02527434|OG004|Outcome|PDAC - MEDI|Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
11197787|NCT02173769|FG000|Participant Flow|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
11197788|NCT02173769|OG000|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
11197789|NCT02173769|EG000|Reported Event|Spiriva Respimat + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
11197790|NCT02173769|EG001|Reported Event|Spiriva 18 mcg + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
11197791|NCT02174198|BG000|Baseline|BioOss Collagen|"Intervention: BioOss Collagen at the time of implant placement~BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen"
11197792|NCT02174198|BG001|Baseline|No Bone Graft|No placement of BioOss at the time of implant placement
11197793|NCT02174198|BG002|Baseline|Total|Total of all reporting groups
11197794|NCT02174198|FG000|Participant Flow|BioOss Collagen|"Intervention: BioOss Collagen at the time of implant placement~BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen"
11197795|NCT02174198|FG001|Participant Flow|No Bone Graft|No placement of BioOss at the time of implant placement
11197796|NCT02174198|OG000|Outcome|BioOss Collagen|"Intervention: BioOss Collagen at the time of implant placement~BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen"
11197797|NCT02174198|OG001|Outcome|No Bone Graft|No placement of BioOss at the time of implant placement
11197798|NCT02174198|EG000|Reported Event|BioOss Collagen|"Intervention: BioOss Collagen at the time of implant placement~BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen"
11197799|NCT02174198|EG001|Reported Event|No Bone Graft|No placement of BioOss at the time of implant placement
11197800|NCT02174276|BG000|Baseline|TDF 48 Weeks|Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197801|NCT02174276|BG001|Baseline|TDF + GS-4774 2 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197802|NCT02174276|BG002|Baseline|TDF + GS-4774 10 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197803|NCT02174276|BG003|Baseline|TDF + GS-4774 40 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197804|NCT02174276|BG004|Baseline|Total|Total of all reporting groups
11197805|NCT02174276|FG000|Participant Flow|TDF 48 Weeks|Participants received tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in optional treatment extension phase [OTEP]).
11197806|NCT02174276|FG001|Participant Flow|TDF + GS-4774 2 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197807|NCT02174276|FG002|Participant Flow|TDF + GS-4774 10 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197808|NCT02174276|FG003|Participant Flow|TDF + GS-4774 40 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197809|NCT02174276|OG000|Outcome|TDF 48 Weeks|Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197810|NCT02174276|OG001|Outcome|TDF + GS-4774 2 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197811|NCT02174276|OG002|Outcome|TDF + GS-4774 10 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197812|NCT02174276|OG003|Outcome|TDF + GS-4774 40 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11390901|NCT03948698|BG000|Baseline|CaP TB TIPPI Study|No new information to report
11390902|NCT03948698|FG000|Participant Flow|CaP TB TIPPI Study|No new information to report
11390903|NCT03948698|OG000|Outcome|CaP TB TIPPI Study|No new information to report
10800136|NCT02527434|EG000|Reported Event|UBC- Tremelimumab Monotherapy|Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11241497|NCT02487225|EG000|Reported Event|Pentoxifylline|"Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Pentoxifylline: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors"
11241498|NCT02487225|EG001|Reported Event|Placebo|"Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.~Placebo: A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug"
11241499|NCT02487303|BG000|Baseline|Acetaminophen Intravenous|"(group 1) 1 gram IV acetaminophen every 8 hours for three doses~Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours"
11241500|NCT02487303|BG001|Baseline|Acetaminophen Oral|"(group 2) 1 gram oral acetaminophen every 8 hours for three doses~Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours"
11241501|NCT02487303|BG002|Baseline|No Acetaminophen|(group 3) no acetaminophen
11241502|NCT02487303|BG003|Baseline|Total|Total of all reporting groups
11241503|NCT02487303|FG000|Participant Flow|Acetaminophen Intravenous|"(group 1) 1 gram IV acetaminophen every 8 hours for three doses~Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours"
11241504|NCT02487303|FG001|Participant Flow|Acetaminophen Oral|"(group 2) 1 gram oral acetaminophen every 8 hours for three doses~Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours"
11241505|NCT02487303|FG002|Participant Flow|No Acetaminophen|(group 3) no acetaminophen
11241506|NCT02487303|OG000|Outcome|Acetaminophen Intravenous|"(group 1) 1 gram IV acetaminophen every 8 hours for three doses~Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours"
11241507|NCT02487303|OG001|Outcome|Acetaminophen Oral|"(group 2) 1 gram oral acetaminophen every 8 hours for three doses~Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours"
11241508|NCT02487303|OG002|Outcome|No Acetaminophen|(group 3) no acetaminophen
11241509|NCT02487303|OG000|Outcome|Acetaminophen Intravenous|1 gram IV acetaminophen every 8 hours for three doses
11241510|NCT02487303|OG001|Outcome|Acetaminophen Oral|1 gram oral acetaminophen every 8 hours for three doses
11241511|NCT02487303|OG002|Outcome|No Acetaminophen|No acetaminophen
11241512|NCT02487303|EG000|Reported Event|Acetaminophen Intravenous|"(group 1) 1 gram IV acetaminophen every 8 hours for three doses~Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours"
11241513|NCT02487303|EG001|Reported Event|Acetaminophen Oral|"(group 2) 1 gram oral acetaminophen every 8 hours for three doses~Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours"
11241514|NCT02487303|EG002|Reported Event|No Acetaminophen|(group 3) no acetaminophen
11241515|NCT02487446|BG000|Baseline|Overall Participants|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
11241516|NCT02487446|FG000|Participant Flow|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
11241517|NCT02487446|FG001|Participant Flow|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
11241518|NCT02487446|OG000|Outcome|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
11241519|NCT02487446|OG001|Outcome|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
11241520|NCT02487446|EG000|Reported Event|QVA149|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
11241521|NCT02487446|EG001|Reported Event|Umeclidinium/Vilanterol|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
11241522|NCT02487446|EG002|Reported Event|All Patients|All Patients
11241523|NCT02487472|BG000|Baseline|HZ Cohort|All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
11241524|NCT02487472|FG000|Participant Flow|HZ Cohort|All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
11241525|NCT02487472|OG000|Outcome|HZ Cohort|All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
11241526|NCT02487472|OG001|Outcome|PHN Cohort|All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
11241527|NCT02487472|OG000|Outcome|PHN Cohort|All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
11241528|NCT02487472|EG000|Reported Event|HZ Cohort|All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
11241529|NCT02487485|BG000|Baseline|Ketamine + Sirolimus First, Then Ketamine + Placebo|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of sirolimus 6 mg orally. After two weeks, they received another infusion of ketamine, and a single dose of placebo.
11241530|NCT02487485|BG001|Baseline|Ketamine + Placebo First, Then Ketamine + Sirolimus|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of placebo. After two weeks, they received another infusion of ketamine, and a single dose of sirolimus 6 mg.
11241531|NCT02487485|BG002|Baseline|Total|Total of all reporting groups
11390904|NCT03948698|EG000|Reported Event|CaP TB TIPPI Study|No arms to report
11241532|NCT02487485|FG000|Participant Flow|Ketamine + Sirolimus First, Then Ketamine + Placebo|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of sirolimus 6 mg orally. After two weeks, they received another infusion of ketamine, and a single dose of placebo.
11241533|NCT02487485|FG001|Participant Flow|Ketamine + Placebo First, Then Ketamine + Sirolimus|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of placebo. After two weeks, they received another infusion of ketamine, and a single dose of sirolimus 6 mg.
11241534|NCT02487485|OG000|Outcome|Ketamine + Sirolimus|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of sirolimus 6 mg orally.
11241535|NCT02487485|OG001|Outcome|Ketamine + Placebo|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of placebo.
11241536|NCT02487485|EG000|Reported Event|Ketamine + Sirolimus|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of sirolimus 6 mg orally.
11241537|NCT02487485|EG001|Reported Event|Ketamine + Placebo|Participants received ketamine 0.5 mg/kg infused over 40 minutes, combined with a single dose of placebo.
11241538|NCT02487498|BG000|Baseline|Overall Participants|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
11241539|NCT02487498|FG000|Participant Flow|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
11241540|NCT02487498|FG001|Participant Flow|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
11241541|NCT02487498|OG000|Outcome|First QVA149, Then Umeclidinium/Vilanterol|Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
11241542|NCT02487498|OG001|Outcome|First Umeclidinium/Vilanterol, Then QVA149|Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
11241543|NCT02487498|EG000|Reported Event|QVA 27.5/12.5 Bid|QVA149 capsules for inhalation, delivered via QVA149 SDDPI
11241544|NCT02487498|EG001|Reported Event|U/V 62.5/25 od|Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
11241545|NCT02487498|EG002|Reported Event|All Patients|All Patients
11241546|NCT02487563|BG000|Baseline|Experimental Group 1|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3), combined with rhTPO 15000 U daily subcutaneously beginning on day 4 and continuing until the response was achieved or the time of initial evaluation.
11241547|NCT02487563|BG001|Baseline|Experimental Group 2|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3) alone.
11241548|NCT02487563|BG002|Baseline|Control Group|Conventional therapies with recommended options including rhTPO, eltrombopag, immunoglobulin, rituximab, interleukin-11 and glucocorticoids, alone or in combination.
11241549|NCT02487563|BG003|Baseline|Total|Total of all reporting groups
11241550|NCT02487563|FG000|Participant Flow|Experimental Group 1|"Decitabine in combination with rhTPO.~Decitabine: Decitabine~rhTPO: rhTPO"
11241551|NCT02487563|FG001|Participant Flow|Experimental Group 2|"Decitabine~Decitabine: Decitabine"
11241552|NCT02487563|FG002|Participant Flow|Control Group|"Conventional treatment except decitabine.~Conventional Treatment: immunoglobulin, glucocorticoid etc"
11241553|NCT02487563|OG000|Outcome|Experimental Group 1|"Decitabine in combination with rhTPO.~Decitabine: Decitabine~rhTPO: rhTPO"
11241554|NCT02487563|OG001|Outcome|Experimental Group 2|"Decitabine~Decitabine: Decitabine"
11241555|NCT02487563|OG002|Outcome|Control Group|"Conventional treatment except decitabine.~Conventional Treatment: immunoglobulin, glucocorticoid etc"
11241556|NCT02487563|OG000|Outcome|Experimental Group 1|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3), combined with rhTPO 15000 U daily subcutaneously beginning on day 4 and continuing until the response was achieved or the time of initial evaluation.
11241557|NCT02487563|OG001|Outcome|Experimental Group 2|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3) alone.
11241558|NCT02487563|OG002|Outcome|Control Group|Conventional therapies with recommended options including rhTPO, eltrombopag, immunoglobulin, rituximab, interleukin-11 and glucocorticoids, alone or in combination.
11241559|NCT02487563|EG000|Reported Event|Experimental Group 1|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3), combined with rhTPO 15000 U daily subcutaneously beginning on day 4 and continuing until the response was achieved or the time of initial evaluation.
11390905|NCT03901144|BG000|Baseline|Subject Using 3 Creams|Each subject used three creams on their volar forearms and had one skin area untreated 4 treated skin areas: Test cream Glycerol cream Cream without humectants Untreated
11241560|NCT02487563|EG001|Reported Event|Experimental Group 2|Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3) alone.
11241561|NCT02487563|EG002|Reported Event|Control Group|Conventional therapies with recommended options including rhTPO, eltrombopag, immunoglobulin, rituximab, interleukin-11 and glucocorticoids, alone or in combination.
11241562|NCT02487771|BG000|Baseline|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
11241563|NCT02487771|BG001|Baseline|DHA Capsule|DHA: 600 mg DHA capsule
11241564|NCT02487771|BG002|Baseline|Total|Total of all reporting groups
11241565|NCT02487771|FG000|Participant Flow|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
11241566|NCT02487771|FG001|Participant Flow|DHA Capsule|DHA: 600 mg DHA capsule
11241567|NCT02487771|OG000|Outcome|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
11241568|NCT02487771|OG001|Outcome|DHA Capsule|DHA: 600 mg DHA capsule
11390906|NCT03901144|FG000|Participant Flow|Test Cream (2% Urea/20% Glycerol)|All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days
11390907|NCT03901144|FG001|Participant Flow|Reference Cream 1: Miniderm® 20% Cream (20% Glycerol)|All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days
11390908|NCT03901144|FG002|Participant Flow|Reference Cream 2: Diprobase® Cream (Cream Without Humectants)|All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days
11390909|NCT03901144|FG003|Participant Flow|Untreated|All participants used 3 creams on their lower volar forearms and one area was left untreated. No cream was applied on this area
11390910|NCT03901144|OG000|Outcome|Test Cream (2% Urea/20% Glycerol)|"Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days~Test cream: Moisturizing cream for topical application"
11390911|NCT03901144|OG001|Outcome|Reference Cream 1: Miniderm® 20% Cream (20% Glycerol)|"Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days~Glycerol cream: Moisturizing cream for topical application"
11390912|NCT03901144|OG002|Outcome|Reference Cream 2: Diprobase® Cream (Cream Without Humectants)|"Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days~Cream without humectants: Emollient cream for topical application"
11390913|NCT03901144|OG003|Outcome|Untreated|Untreated are on the volar forearm
11390914|NCT03901144|EG000|Reported Event|Test Cream (2% Urea/20% Glycerol)|1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days
11390915|NCT03901144|EG001|Reported Event|Reference Cream 1: Miniderm® 20% Cream (20% Glycerol)|1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days
11390916|NCT03901144|EG002|Reported Event|Reference Cream 2: Diprobase® Cream (Cream Without Humectants)|1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days
11390917|NCT03901144|EG003|Reported Event|Untreated|1 of 4 skin areas on the lower volar forearm of the participant was left untreated
11390918|NCT03561701|BG000|Baseline|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390919|NCT03561701|BG001|Baseline|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390920|NCT03561701|BG002|Baseline|Total|Total of all reporting groups
11390921|NCT03561701|FG000|Participant Flow|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390922|NCT03561701|FG001|Participant Flow|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390923|NCT03561701|OG000|Outcome|Oteseconazole (VT-1161)|1 oteseconazole150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390924|NCT03561701|OG001|Outcome|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390925|NCT03561701|EG000|Reported Event|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390926|NCT03561701|EG001|Reported Event|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
11390927|NCT03525808|BG000|Baseline|AXIOS Stent and Electrocautery Enhanced Delivery System|"Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.~AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall."
11390928|NCT03525808|FG000|Participant Flow|AXIOS Stent and Electrocautery Enhanced Delivery System|"Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.~AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall."
11390929|NCT03525808|OG000|Outcome|AXIOS|"Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.~AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall."
11390930|NCT03525808|EG000|Reported Event|AXIOS|"Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.~AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall."
11390931|NCT03461211|BG000|Baseline|Teprotumumab (OPTIC Placebo)|Participants who received placebo in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390932|NCT03461211|BG001|Baseline|Teprotumumab (OPTIC Teprotumumab)|Participants who received teprotumumab in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390933|NCT03461211|BG002|Baseline|Total|Total of all reporting groups
11390934|NCT03461211|FG000|Participant Flow|Teprotumumab (OPTIC Placebo)|Participants who received placebo in OPTIC received 8 infusions of open-label teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390935|NCT03461211|FG001|Participant Flow|Teprotumumab (OPTIC Teprotumumab)|Participants who received teprotumumab in OPTIC received 8 infusions of open-label teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390936|NCT03461211|OG000|Outcome|Teprotumumab (OPTIC Placebo)|Participants who received placebo in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390937|NCT03461211|OG001|Outcome|Teprotumumab (OPTIC Teprotumumab)|Participants who received teprotumumab in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390938|NCT03461211|EG000|Reported Event|Treatment Period: Teprotumumab (OPTIC Placebo)|Participants who received placebo in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390939|NCT03461211|EG001|Reported Event|Treatment Period: Teprotumumab (OPTIC Teprotumumab)|Participants who received teprotumumab in OPTIC received 8 infusions of teprotumumab every 3 weeks (q3W) for a total of 21 weeks: teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
11390940|NCT03461211|EG002|Reported Event|Follow-Up Period: No Treatment (OPTIC Placebo)|Participants who received placebo in OPTIC and were proptosis non-responders. Participants received 8 infusions of teprotumumab q3W for a total of 21 weeks in OPTIC-X and entered a 24-week Follow-up Period; no trial drug was administered.
11390941|NCT03461211|EG003|Reported Event|Follow-Up Period: No Treatment (OPTIC Teprotumumab)|Participants who received teprotumumab in OPTIC and were proptosis non-responders. Participants received 8 infusions of teprotumumab q3W for a total of 21 weeks in OPTIC-X and entered a 24-week Follow-up Period; no trial drug was administered.
11390942|NCT03276780|BG000|Baseline|In Vivo|"Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390943|NCT03276780|BG001|Baseline|Standard of Care|"Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390944|NCT03276780|BG002|Baseline|Total|Total of all reporting groups
11390945|NCT03276780|FG000|Participant Flow|In Vivo|"Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390946|NCT03276780|FG001|Participant Flow|Standard of Care|"Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390947|NCT03276780|OG000|Outcome|In Vivo|"Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390948|NCT03276780|OG001|Outcome|Standard of Care|"Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390949|NCT03276780|OG000|Outcome|Total Participants Screened|The total number of participants who were screened for potential enrollment in the study.
11390950|NCT03276780|OG000|Outcome|Total Participants Enrolled|The total number of participants enrolled in the study.
11197813|NCT02174276|EG000|Reported Event|TDF 48 Weeks|Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197814|NCT02174276|EG001|Reported Event|TDF + GS-4774 2 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197815|NCT02174276|EG002|Reported Event|TDF + GS-4774 10 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11241569|NCT02487771|EG000|Reported Event|Placebo Capsule|Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
11390951|NCT03276780|EG000|Reported Event|In Vivo|"Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390952|NCT03276780|EG001|Reported Event|Standard of Care|"Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.~Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking~combination NRT: Both groups will receive combination NRT to help with smoking cessation"
11390953|NCT03205553|BG000|Baseline|Standard of Care (SoC) Treatment Group|"The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.~SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days."
11390954|NCT03205553|BG001|Baseline|Direct Peritoneal Resuscitation (DPR) Treatment Group|"The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement).~SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties.~Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain."
11390955|NCT03205553|BG002|Baseline|Total|Total of all reporting groups
11390956|NCT03205553|FG000|Participant Flow|Standard of Care (SoC) Treatment Group|"The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.~SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days."
11390957|NCT03205553|FG001|Participant Flow|Direct Peritoneal Resuscitation (DPR) Treatment Group|"The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement).~SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties.~Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain."
11390958|NCT03205553|OG000|Outcome|Standard of Care (SoC) Treatment Group|"The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.~SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days."
10965914|NCT00884611|OG000|Outcome|Algorithm 1 - Control Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
11390959|NCT03205553|OG001|Outcome|Direct Peritoneal Resuscitation (DPR) Treatment Group|"The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement).~SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties.~Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain."
11390960|NCT03205553|EG000|Reported Event|Standard of Care (SoC) Treatment Group|"The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.~SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days."
11390961|NCT03205553|EG001|Reported Event|Direct Peritoneal Resuscitation (DPR) Treatment Group|"The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement).~SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties.~Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain."
11390962|NCT03104205|BG000|Baseline|Evaluate Home-based MOWI|"Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.~Evaluate home-based MOWI: MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192)."
11390963|NCT03104205|FG000|Participant Flow|MOWI Group|Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
11390964|NCT03104205|OG000|Outcome|MOWI Group|Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
11390965|NCT03104205|EG000|Reported Event|MOWI Group|Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
11390966|NCT03050814|BG000|Baseline|Standard of Care (SOC) - Arm A|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine until disease progression.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day.~5-Fluorouracil (FU): 400mg/m^2 intravenous (IV) bolus on day 1.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 1.~Oxaliplatin: 85mg/m^2 intravenous (IV) over 2 hours on day 1.~Capecitabine: 625 mg/m^2 twice a day by mouth. 5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on Day 1."
11390967|NCT03050814|BG001|Baseline|Standard of Care (SOC) - Arm B + Lead in|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + avelumab + Ad-CEA vaccine (given weeks 0,2,4,8,12,16 and then every 12 weeks) for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine + avelumab + Ad-CEA vaccine (following the every 12-week dosing schedule) until disease progression.~Avelumab: 10 mg/kg intravenous (IV) over 30-60 min on day 1~Ad-CEA vaccine: Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day 2.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 2.~Oxaliplatin: 68mg/m^2 intravenous (IV) over 2 hours on day 2.~Capecitabine: 625 mg/m^2 twice a day by mouth.~5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on day 2."
11390968|NCT03050814|BG002|Baseline|Enrolled But Not Assigned to a Treatment Arm|4 participants were enrolled but not treated on Arm A or Arm B. Only baseline data were captured.
11390969|NCT03050814|BG003|Baseline|Total|Total of all reporting groups
11390970|NCT03050814|FG000|Participant Flow|Standard of Care (SOC) - Arm A|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine until disease progression.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day.~5-Fluorouracil (FU): 400mg/m^2 intravenous (IV) bolus on day 1.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 1.~Oxaliplatin: 85mg/m^2 intravenous (IV) over 2 hours on day 1.~Capecitabine: 625 mg/m^2 twice a day by mouth. 5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on Day 1."
11390971|NCT03050814|FG001|Participant Flow|Standard of Care (SOC) - Arm B + Lead in|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + avelumab + Ad-CEA vaccine (given weeks 0,2,4,8,12,16 and then every 12 weeks) for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine + avelumab + Ad-CEA vaccine (following the every 12-week dosing schedule) until disease progression.~Avelumab: 10 mg/kg intravenous (IV) over 30-60 min on day 1~Ad-CEA vaccine: Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day 2.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 2.~Oxaliplatin: 68mg/m^2 intravenous (IV) over 2 hours on day 2.~Capecitabine: 625 mg/m^2 twice a day by mouth.~5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on day 2."
11390972|NCT03050814|FG002|Participant Flow|Enrolled But Not Assigned to a Treatment Arm|4 participants were enrolled but not treated on Arm A or Arm B. Only baseline data were captured.
11390973|NCT03050814|OG000|Outcome|Standard of Care (SOC) - Arm A|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine until disease progression.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day.~5-Fluorouracil (FU): 400mg/m^2 intravenous (IV) bolus on day 1.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 1.~Oxaliplatin: 85mg/m^2 intravenous (IV) over 2 hours on day 1.~Capecitabine: 625 mg/m^2 twice a day by mouth. 5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on Day 1."
11390974|NCT03050814|OG001|Outcome|Standard of Care (SOC) - Arm B + Lead in|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + avelumab + Ad-CEA vaccine (given weeks 0,2,4,8,12,16 and then every 12 weeks) for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine + avelumab + Ad-CEA vaccine (following the every 12-week dosing schedule) until disease progression.~Avelumab: 10 mg/kg intravenous (IV) over 30-60 min on day 1~Ad-CEA vaccine: Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day 2.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 2.~Oxaliplatin: 68mg/m^2 intravenous (IV) over 2 hours on day 2.~Capecitabine: 625 mg/m^2 twice a day by mouth.~5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on day 2."
11390975|NCT03050814|EG000|Reported Event|Standard of Care (SOC) - Arm A|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine until disease progression.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day.~5-Fluorouracil (FU): 400mg/m^2 intravenous (IV) bolus on day 1.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 1.~Oxaliplatin: 85mg/m^2 intravenous (IV) over 2 hours on day 1.~Capecitabine: 625 mg/m^2 twice a day by mouth. 5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on Day 1."
11390976|NCT03050814|EG001|Reported Event|Standard of Care (SOC) - Arm B + Lead in|"Participants will receive leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX)- + bevacizumab + avelumab + Ad-CEA vaccine (given weeks 0,2,4,8,12,16 and then every 12 weeks) for up to 12 2-week cycles followed by maintenance therapy with bevacizumab + capecitabine + avelumab + Ad-CEA vaccine (following the every 12-week dosing schedule) until disease progression.~Avelumab: 10 mg/kg intravenous (IV) over 30-60 min on day 1~Ad-CEA vaccine: Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.~Bevacizumab: 5mg/kg intravenous (IV) over 30-90 min on day 2.~Leucovorin: 400mg/m^2 intravenous (IV) over 2 hours on day 2.~Oxaliplatin: 68mg/m^2 intravenous (IV) over 2 hours on day 2.~Capecitabine: 625 mg/m^2 twice a day by mouth.~5-Fluorouracil (FU): 2400 mg/m^2 intravenous (IV) over 46 hours (+/-2 hours) to start on day 2."
11390977|NCT02797262|BG000|Baseline|Intervention|"Building on the available Proteus devices, the investigators will design and create a Proteus digital health feedback (PDHF) system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).~The investigators will test overall utility (including feasibility, acceptability and sustainability) of the PDHF system, its accuracy for measuring adherence and its impact on enhancing patients' level of adherence and the effect on virologic and clinical outcomes (exploratory), the retention of its impact on keeping up with adherence and improvement of plasma HIV RNA and CD4 cell count after the 16-week usage of the PDHF system.~Proteus digital health feedback (PDHF) system: Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT)."
11390978|NCT02797262|BG001|Baseline|Control|UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. Eligible patients will be randomized to one of the two conditions using a stratified urn randomization procedure to increase the likelihood of balanced allocation of prognostic variables at baseline.
11390979|NCT02797262|BG002|Baseline|Total|Total of all reporting groups
10800137|NCT02527434|EG001|Reported Event|TNBC - Tremelimumab Monotherapy|Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11390980|NCT02797262|FG000|Participant Flow|Intervention|"Building on the available Proteus devices, the investigators will design and create a Proteus digital health feedback (PDHF) system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).~The investigators will test overall utility (including feasibility, acceptability and sustainability) of the PDHF system, its accuracy for measuring adherence and its impact on enhancing patients' level of adherence and the effect on virologic and clinical outcomes (exploratory), the retention of its impact on keeping up with adherence and improvement of plasma HIV RNA and CD4 cell count after the 16-week usage of the PDHF system.~Proteus digital health feedback (PDHF) system: Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT)."
11390981|NCT02797262|FG001|Participant Flow|Control|Usual care (UC) is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. Eligible patients will be randomized to one of the two conditions using a stratified urn randomization procedure to increase the likelihood of balanced allocation of prognostic variables at baseline.
11390982|NCT02797262|OG000|Outcome|Intervention|"Building on the available Proteus devices, the investigators will design and create a Proteus digital health feedback (PDHF) system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).~The investigators will test overall utility (including feasibility, acceptability and sustainability) of the PDHF system, its accuracy for measuring adherence and its impact on enhancing patients' level of adherence and the effect on virologic and clinical outcomes (exploratory), the retention of its impact on keeping up with adherence and improvement of plasma HIV RNA and CD4 cell count after the 16-week usage of the PDHF system.~Proteus digital health feedback (PDHF) system: Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT)."
11390983|NCT02797262|OG001|Outcome|Control|UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. Eligible patients will be randomized to one of the two conditions using a stratified urn randomization procedure to increase the likelihood of balanced allocation of prognostic variables at baseline.
11390984|NCT02797262|EG000|Reported Event|Intervention|"Building on the available Proteus devices, the investigators will design and create a Proteus digital health feedback (PDHF) system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).~The investigators will test overall utility (including feasibility, acceptability and sustainability) of the PDHF system, its accuracy for measuring adherence and its impact on enhancing patients' level of adherence and the effect on virologic and clinical outcomes (exploratory), the retention of its impact on keeping up with adherence and improvement of plasma HIV RNA and CD4 cell count after the 16-week usage of the PDHF system.~Proteus digital health feedback (PDHF) system: Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT)."
11390985|NCT02797262|EG001|Reported Event|Control|UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. Eligible patients will be randomized to one of the two conditions using a stratified urn randomization procedure to increase the likelihood of balanced allocation of prognostic variables at baseline.
11390986|NCT02639910|BG000|Baseline|Cohort A (Tafasitamab+Idelalisib)|Tafasitamab in combination with idelalisib
11390987|NCT02639910|BG001|Baseline|Cohort B (Tafasitamab+Venetoclax)|Tafasitamab in combination with venetoclax
11390988|NCT02639910|BG002|Baseline|Total|Total of all reporting groups
11390989|NCT02639910|FG000|Participant Flow|Cohort A (Tafasitamab+Idelalisib)|"Tafasitamab (MOR208) in combination with idelalisib~Tafasitamab dose: 12 mg/kg intravenous infusion~Idelalisib dose: 150 mg twice daily orally"
11390990|NCT02639910|FG001|Participant Flow|Cohort B (Tafasitamab+Venetoclax)|"Tafasitamab (MOR208) in combination with venetoclax~Tafasitamab dose: 12 mg/kg intravenous infusion~Venetoclax dose: 400 mg once daily orally"
11390991|NCT02639910|OG000|Outcome|Cohort A (Tafasitamab+Idelalisib)|Tafasitamab in combination with idelalisib
11390992|NCT02639910|OG001|Outcome|Cohort B (Tafasitamab+Venetoclax)|Tafasitamab in combination with venetoclax
11390993|NCT02639910|EG000|Reported Event|Cohort A (Tafasitamab+Idelalisib)|Tafasitamab in combination with idelalisib
11390994|NCT02639910|EG001|Reported Event|Cohort B (Tafasitamab+Venetoclax)|Tafasitamab in combination with venetoclax
11390995|NCT02409368|BG000|Baseline|ECOG (PS0)|"ECOG Performance Status 0~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11390996|NCT02409368|BG001|Baseline|ECOG (PS1)|"ECOG Performance Status 1~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11390997|NCT02409368|BG002|Baseline|ECOG (PS 2)|"ECOG Performance Status 2~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11390998|NCT02409368|BG003|Baseline|Total|Total of all reporting groups
11390999|NCT02409368|FG000|Participant Flow|ECOG (PS0)|"ECOG Performance Status 0~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391000|NCT02409368|FG001|Participant Flow|ECOG (PS1)|"ECOG Performance Status 1~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391001|NCT02409368|FG002|Participant Flow|ECOG (PS 2)|"ECOG Performance Status 2~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391002|NCT02409368|OG000|Outcome|ECOG (PS0)|"ECOG Performance Status 0~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391003|NCT02409368|OG001|Outcome|ECOG (PS1)|"ECOG Performance Status 1~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391004|NCT02409368|OG002|Outcome|ECOG (PS 2)|"ECOG Performance Status 2~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391005|NCT02409368|EG000|Reported Event|ECOG PS 0|"ECOG Performance Status 0~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391006|NCT02409368|EG001|Reported Event|ECOG PS 1|"ECOG Performance Status 1~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391007|NCT02409368|EG002|Reported Event|ECOG PS 2|"ECOG Performance Status 2~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391008|NCT02409368|EG003|Reported Event|Total|"Total~nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks"
11391009|NCT02322593|BG000|Baseline|TAS-118/Oxaliplatin|"TAS-118 plus Oxaliplatin~L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391010|NCT02322593|BG001|Baseline|S-1/Cisplatin|"S-1 plus Cisplatin~CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391011|NCT02322593|BG002|Baseline|Total|Total of all reporting groups
11391012|NCT02322593|FG000|Participant Flow|TAS-118/Oxaliplatin|"TAS-118 plus Oxaliplatin~L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391013|NCT02322593|FG001|Participant Flow|S-1/Cisplatin|"S-1 plus Cisplatin~CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391014|NCT02322593|OG000|Outcome|TAS-118/Oxaliplatin|"TAS-118 plus Oxaliplatin~L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391015|NCT02322593|OG001|Outcome|S-1/Cisplatin|"S-1 plus Cisplatin~CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391016|NCT02322593|EG000|Reported Event|TAS-118/Oxaliplatin|"TAS-118 plus Oxaliplatin~L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391017|NCT02322593|EG001|Reported Event|S-1/Cisplatin|"S-1 plus Cisplatin~CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met."
11391018|NCT02124824|BG000|Baseline|Arm 1: Control|"Control~BQ-123: Endothelin subtype A antagonist"
11391019|NCT02124824|BG001|Baseline|Arm 2: Heart Failure|"Heart Failure~BQ-123: Endothelin subtype A antagonist"
11391020|NCT02124824|BG002|Baseline|Total|Total of all reporting groups
11391021|NCT02124824|FG000|Participant Flow|Arm 1: Control|"Control~BQ-123: Endothelin subtype A antagonist"
11391022|NCT02124824|FG001|Participant Flow|Arm 2: Heart Failure|"Heart Failure~BQ-123: Endothelin subtype A antagonist"
11391023|NCT02124824|OG000|Outcome|Arm 1: Control|"Control~BQ-123: Endothelin subtype A antagonist"
11391024|NCT02124824|OG001|Outcome|Arm 2: Heart Failure|"Heart Failure~BQ-123: Endothelin subtype A antagonist"
11391025|NCT02124824|EG000|Reported Event|Arm 1: Control|"Control~BQ-123: Endothelin subtype A antagonist"
11391026|NCT02124824|EG001|Reported Event|Arm 2: Heart Failure|"Heart Failure~BQ-123: Endothelin subtype A antagonist"
11391027|NCT01772004|BG000|Baseline|Dose Escalation Cohort: Avelumab 1.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391028|NCT01772004|BG001|Baseline|Dose Escalation Cohort: Avelumab 3.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
11391029|NCT01772004|BG002|Baseline|Dose Escalation Cohort: Avelumab 10.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391030|NCT01772004|BG003|Baseline|Dose Escalation Cohort: Avelumab 20.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391031|NCT01772004|BG004|Baseline|Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391032|NCT01772004|BG005|Baseline|Primary Expansion Cohort: NSCLC, Post-platinum Doublet|Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391033|NCT01772004|BG006|Baseline|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391034|NCT01772004|BG007|Baseline|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391035|NCT01772004|BG008|Baseline|Primary Expansion Cohort: GC/GEJC Progressed|Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391036|NCT01772004|BG009|Baseline|Primary Expansion Cohort: GC/GEJC Non Progressed|Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391037|NCT01772004|BG010|Baseline|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391038|NCT01772004|BG011|Baseline|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391039|NCT01772004|BG012|Baseline|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391040|NCT01772004|BG013|Baseline|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391041|NCT01772004|BG014|Baseline|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391042|NCT01772004|BG015|Baseline|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391043|NCT01772004|BG016|Baseline|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391044|NCT01772004|BG017|Baseline|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391045|NCT01772004|BG018|Baseline|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391046|NCT01772004|BG019|Baseline|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11197816|NCT02174276|EG003|Reported Event|TDF + GS-4774 40 YU|Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
11197817|NCT02174419|BG000|Baseline|Nalbuphine HCl ER 90mg|"nalbuphine HCl ER tablets 90 mg BID~nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks"
11241570|NCT02487771|EG001|Reported Event|DHA Capsule|DHA: 600 mg DHA capsule
11391047|NCT01772004|BG020|Baseline|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391048|NCT01772004|BG021|Baseline|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391049|NCT01772004|BG022|Baseline|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391050|NCT01772004|BG023|Baseline|Total|Total of all reporting groups
11391051|NCT01772004|FG000|Participant Flow|Dose Escalation Cohort: Avelumab 1.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
11391052|NCT01772004|FG001|Participant Flow|Dose Escalation Cohort: Avelumab 3.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391053|NCT01772004|FG002|Participant Flow|Dose Escalation Cohort: Avelumab 10.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391054|NCT01772004|FG003|Participant Flow|Dose Escalation Cohort: Avelumab 20.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391055|NCT01772004|FG004|Participant Flow|Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391056|NCT01772004|FG005|Participant Flow|Primary Expansion Cohort: NSCLC, Post-platinum Doublet|Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11197818|NCT02174419|BG001|Baseline|Nalbuphine HCl ER 180 mg|"nalbuphine HCl ER tablets 180 mg BID~nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks"
11197819|NCT02174419|BG002|Baseline|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 10 weeks"
11197820|NCT02174419|BG003|Baseline|Total|Total of all reporting groups
11391057|NCT01772004|FG006|Participant Flow|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11197821|NCT02174419|FG000|Participant Flow|Nalbuphine HCl ER 90mg|"nalbuphine HCl ER tablets 90 mg BID~nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks"
11197822|NCT02174419|FG001|Participant Flow|Nalbuphine HCl ER 180 mg|"nalbuphine HCl ER tablets 180 mg BID~nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks"
11197823|NCT02174419|FG002|Participant Flow|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 10 weeks"
11391058|NCT01772004|FG007|Participant Flow|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391059|NCT01772004|FG008|Participant Flow|Primary Expansion Cohort: GC/GEJC Progressed|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391060|NCT01772004|FG009|Participant Flow|Primary Expansion Cohort: GC/GEJC Non Progressed|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11197824|NCT02174419|OG000|Outcome|Nalbuphine HCl ER 90mg|"nalbuphine HCl ER tablets 90 mg BID~nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks"
11197825|NCT02174419|OG001|Outcome|Nalbuphine HCl ER 180 mg|"nalbuphine HCl ER tablets 180 mg BID~nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks"
11197826|NCT02174419|OG002|Outcome|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 10 weeks"
11197827|NCT02174419|EG000|Reported Event|Nalbuphine HCl ER 90mg|"nalbuphine HCl ER tablets 90 mg BID~nalbuphine HCl ER tablets 90 mg BID: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks"
11197828|NCT02174419|EG001|Reported Event|Nalbuphine HCl ER 180 mg|"nalbuphine HCl ER tablets 180 mg BID~nalbuphine HCl ER tablets 180 mg BID: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks"
11391061|NCT01772004|FG010|Participant Flow|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391062|NCT01772004|FG011|Participant Flow|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391063|NCT01772004|FG012|Participant Flow|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391064|NCT01772004|FG013|Participant Flow|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391065|NCT01772004|FG014|Participant Flow|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391066|NCT01772004|FG015|Participant Flow|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391067|NCT01772004|FG016|Participant Flow|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391068|NCT01772004|FG017|Participant Flow|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391069|NCT01772004|FG018|Participant Flow|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391070|NCT01772004|FG019|Participant Flow|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391071|NCT01772004|FG020|Participant Flow|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391072|NCT01772004|FG021|Participant Flow|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391073|NCT01772004|FG022|Participant Flow|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391074|NCT01772004|OG000|Outcome|Dose Escalation Cohort: Avelumab 1.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
11391075|NCT01772004|OG001|Outcome|Dose Escalation Cohort: Avelumab 3.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391076|NCT01772004|OG002|Outcome|Dose Escalation Cohort: Avelumab 10.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391077|NCT01772004|OG003|Outcome|Dose Escalation Cohort: Avelumab 20.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391078|NCT01772004|OG000|Outcome|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391079|NCT01772004|OG000|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
10800138|NCT02527434|EG002|Reported Event|PDAC- Tremelimumab Monotherapy|Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
11391080|NCT01772004|OG000|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391081|NCT01772004|OG000|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391082|NCT01772004|OG004|Outcome|Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391083|NCT01772004|OG005|Outcome|Primary Expansion Cohort: NSCLC, Post-platinum Doublet|Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391084|NCT01772004|OG006|Outcome|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391085|NCT01772004|OG007|Outcome|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391086|NCT01772004|OG008|Outcome|Primary Expansion Cohort: GC/GEJC Progressed|Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391087|NCT01772004|OG009|Outcome|Primary Expansion Cohort: GC/GEJC Non Progressed|Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391088|NCT01772004|OG010|Outcome|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391089|NCT01772004|OG011|Outcome|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391090|NCT01772004|OG012|Outcome|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391091|NCT01772004|OG013|Outcome|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391092|NCT01772004|OG014|Outcome|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391093|NCT01772004|OG015|Outcome|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391094|NCT01772004|OG016|Outcome|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391095|NCT01772004|OG017|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391096|NCT01772004|OG018|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391097|NCT01772004|OG019|Outcome|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11197829|NCT02174419|EG002|Reported Event|Sugar Pill|"Placebo tablets BID~Placebo tablets BID: Placebo tablets BID administered for 10 weeks"
11197830|NCT02174432|BG000|Baseline|Nalbuphine HCl ER|"nalbuphine HCl ER~nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks"
11197831|NCT02174432|FG000|Participant Flow|Nalbuphine HCl ER|"nalbuphine HCl ER~nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks"
11197832|NCT02174432|OG000|Outcome|Nalbuphine HCl ER|"nalbuphine HCl ER~nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks"
11197833|NCT02174432|EG000|Reported Event|Nalbuphine HCl ER|"nalbuphine HCl ER~nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks"
11197834|NCT02174510|BG000|Baseline|20mg Lurasidone|20mg lurasidone: single oral lurasidone.
11197835|NCT02174510|BG001|Baseline|40mg Lurasidone|40mg lurasidone: single oral lurasidone.
11197836|NCT02174510|BG002|Baseline|80mg Lurasidone|80mg lurasidone: single oral lurasidone.
11197837|NCT02174510|BG003|Baseline|Placebo|Subjects administered placebo tablet at the same time with each lurasidone group.
11197838|NCT02174510|BG004|Baseline|Total|Total of all reporting groups
11197839|NCT02174510|FG000|Participant Flow|20mg Lurasidone|20mg lurasidone: single oral lurasidone.
11197840|NCT02174510|FG001|Participant Flow|40mg Lurasidone|40mg lurasidone: single oral lurasidone.
11197841|NCT02174510|FG002|Participant Flow|80mg Lurasidone|80mg lurasidone: single oral lurasidone.
11197842|NCT02174510|FG003|Participant Flow|Placebo|Subjects administered placebo tablet at the same time with each lurasidone group.
11197843|NCT02174510|OG000|Outcome|20mg Lurasidone|20mg lurasidone: single oral lurasidone.
11197844|NCT02174510|OG001|Outcome|40mg Lurasidone|40mg lurasidone: single oral lurasidone.
11197845|NCT02174510|OG002|Outcome|80mg Lurasidone|80mg lurasidone: single oral lurasidone.
11197846|NCT02174510|EG000|Reported Event|20mg Lurasidone|20mg lurasidone: single oral lurasidone.
11197847|NCT02174510|EG001|Reported Event|40mg Lurasidone|40mg lurasidone: single oral lurasidone.
11197848|NCT02174510|EG002|Reported Event|80mg Lurasidone|80mg lurasidone: single oral lurasidone.
11197849|NCT02174510|EG003|Reported Event|Placebo|Subjects administered placebo tablet at the same time with each lurasidone group.
11197850|NCT02174523|BG000|Baseline|40mg Lurasidone|Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8.
11197851|NCT02174523|BG001|Baseline|Placebo|Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.
11197852|NCT02174523|BG002|Baseline|Total|Total of all reporting groups
11197853|NCT02174523|FG000|Participant Flow|40mg Lurasidone|Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8.
11197854|NCT02174523|FG001|Participant Flow|Placebo|Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.
11197855|NCT02174523|OG000|Outcome|40mg Lurasidone|Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8.
11197856|NCT02174523|EG000|Reported Event|40mg Lurasidone|Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8.
11197857|NCT02174523|EG001|Reported Event|Placebo|Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.
11197858|NCT02174562|BG000|Baseline|Primary Care-Occupational Therapy|"PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).~Primary Care-Occupational Therapy: PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet)."
11197859|NCT02174562|BG001|Baseline|Enhanced Usual Care|"Usual care enhanced with education and controls for attention~Enhanced Usual Care: Usual care enhanced with education and attention"
11197860|NCT02174562|BG002|Baseline|Total|Total of all reporting groups
11197861|NCT02174562|FG000|Participant Flow|Primary Care-Occupational Therapy|"PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).~Primary Care-Occupational Therapy: PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet)."
11197862|NCT02174562|FG001|Participant Flow|Enhanced Usual Care|"Usual care enhanced with education and controls for attention~Enhanced Usual Care: Usual care enhanced with education and attention"
11197863|NCT02174562|OG000|Outcome|Primary Care-Occupational Therapy|"PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).~Primary Care-Occupational Therapy: PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet)."
11197864|NCT02174562|OG001|Outcome|Enhanced Usual Care|"Usual care enhanced with education and controls for attention~Enhanced Usual Care: Usual care enhanced with education and attention"
11241571|NCT02487810|BG000|Baseline|Intuitive|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions."
11241572|NCT02487810|BG001|Baseline|Deliberative|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions"
11241573|NCT02487810|BG002|Baseline|Total|Total of all reporting groups
11241574|NCT02487810|FG000|Participant Flow|Intuitive|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions."
11241575|NCT02487810|FG001|Participant Flow|Deliberative|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions"
11241576|NCT02487810|OG000|Outcome|Intuitive Arm|
11241577|NCT02487810|OG001|Outcome|Deliberative Arm|
11241578|NCT02487810|EG000|Reported Event|Intuitive|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions."
11241579|NCT02487810|EG001|Reported Event|Deliberative|"Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions.~Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions"
11241580|NCT02487966|BG000|Baseline|Active tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist."
11241581|NCT02487966|BG001|Baseline|Active tDCS and Sham Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241582|NCT02487966|BG002|Baseline|Sham tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation."
11340612|NCT03661541|OG001|Outcome|Group B: 1 or 2 Herpes Labialis Outbreaks in Prior 12 Months, Day 1|"Group B: Subjects positive for Ab against HSV-1 and self-reporting 1 or 2 herpes labialis outbreaks in the prior 12 months.~Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Results from blood draw on day 1."
11241583|NCT02487966|BG003|Baseline|Sham tDCS and Sham Mirrory Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241584|NCT02487966|BG004|Baseline|Total|Total of all reporting groups
11241585|NCT02487966|FG000|Participant Flow|Active tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist."
11241586|NCT02487966|FG001|Participant Flow|Active tDCS and Sham Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241587|NCT02487966|FG002|Participant Flow|Sham tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation."
11241588|NCT02487966|FG003|Participant Flow|Sham tDCS and Sham Mirrory Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241589|NCT02487966|OG000|Outcome|Active tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist."
10803938|NCT01049035|OG004|Outcome|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11391098|NCT01772004|OG020|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391099|NCT01772004|OG021|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391100|NCT01772004|OG022|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391101|NCT01772004|OG000|Outcome|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391102|NCT01772004|OG001|Outcome|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391103|NCT01772004|OG002|Outcome|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391104|NCT01772004|OG003|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma (Second line) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391105|NCT01772004|OG004|Outcome|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391106|NCT01772004|OG005|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391107|NCT01772004|OG006|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric and gastroesophageal cancer treated with a first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391108|NCT01772004|OG007|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391109|NCT01772004|OG000|Outcome|Primary Expansion Cohort: NSCLC, Post-platinum Doublet|Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391110|NCT01772004|OG001|Outcome|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391111|NCT01772004|OG002|Outcome|Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed)|Participants with gastric and gastroesophageal cancer who progressed/non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391112|NCT01772004|OG003|Outcome|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391113|NCT01772004|OG004|Outcome|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391114|NCT01772004|OG005|Outcome|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391115|NCT01772004|OG006|Outcome|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391116|NCT01772004|OG007|Outcome|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391117|NCT01772004|OG008|Outcome|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391118|NCT01772004|OG009|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391119|NCT01772004|OG010|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391120|NCT01772004|OG011|Outcome|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391121|NCT01772004|OG012|Outcome|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391122|NCT01772004|OG013|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391123|NCT01772004|OG014|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391124|NCT01772004|OG015|Outcome|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391125|NCT01772004|OG016|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391126|NCT01772004|OG002|Outcome|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391127|NCT01772004|OG003|Outcome|Primary Expansion Cohort: GC/GEJC Progressed|Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391128|NCT01772004|OG004|Outcome|Primary Expansion Cohort: GC/GEJC Non Progressed|Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391129|NCT01772004|OG007|Outcome|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391130|NCT01772004|OG008|Outcome|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391131|NCT01772004|OG009|Outcome|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391132|NCT01772004|OG010|Outcome|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391133|NCT01772004|OG011|Outcome|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391134|NCT01772004|OG012|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391135|NCT01772004|OG013|Outcome|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391136|NCT01772004|OG014|Outcome|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391137|NCT01772004|OG015|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391138|NCT01772004|OG016|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391139|NCT01772004|OG017|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391140|NCT01772004|OG000|Outcome|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391141|NCT01772004|OG001|Outcome|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391142|NCT01772004|OG002|Outcome|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391143|NCT01772004|OG003|Outcome|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391144|NCT01772004|EG000|Reported Event|Dose Escalation Cohort: Avelumab 1.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391145|NCT01772004|EG001|Reported Event|Dose Escalation Cohort: Avelumab 3.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
11391146|NCT01772004|EG002|Reported Event|Dose Escalation Cohort: Avelumab 10.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391147|NCT01772004|EG003|Reported Event|Dose Escalation Cohort: Avelumab 20.0 mg/kg|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
10965915|NCT00884611|OG001|Outcome|Algorithm 1 - Intervention Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
10965916|NCT00884611|OG002|Outcome|Algorithm 2 - Control Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
11391148|NCT01772004|EG004|Reported Event|Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly|Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391149|NCT01772004|EG005|Reported Event|Primary Expansion Cohort: NSCLC, Post-platinum Doublet|Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391150|NCT01772004|EG006|Reported Event|Primary Expansion Cohort: NSCLC, First Line|Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391151|NCT01772004|EG007|Reported Event|Primary Expansion Cohort: Metastatic Breast Cancer|Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11340613|NCT03661541|OG002|Outcome|Group C: Zero Herpes Labialis Outbreaks in Prior 12 Months, Day 1|Group C: 12 subjects positive for Ab against HSV-1 nad self-reporting zero herpes labialis outbreaks in the past 12 months. Blood draw is on day 1. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.
11340614|NCT03661541|OG003|Outcome|Group A, Day 57. Subjects With 6 or More Outbreaks, 8 Weeks After Single Dose of SADBE.|Group A, day 57. Subjects positive for Ab against HSV-1, self-reporting 6 or more herpes labialis outbreaks in the prior 12 months. Blood was collected on day 57 after a single topical dose of SADBE applied to the upper arm on day 1.
11340747|NCT03663179|FG001|Participant Flow|Sham TMS|"Participants will receive 20 sessions of sham TMS over the left DLPFC.~Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340748|NCT03663179|OG000|Outcome|Active TMS|"Participants will receive 20 sessions of active TMS targeting the left DLPFC.~Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340749|NCT03663179|OG001|Outcome|Sham TMS|"Participants will receive 20 sessions of sham TMS over the left DLPFC.~Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340750|NCT03663179|EG000|Reported Event|Active TMS|"Participants will receive 20 sessions of active TMS targeting the left DLPFC.~Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340751|NCT03663179|EG001|Reported Event|Sham TMS|"Participants will receive 20 sessions of sham TMS over the left DLPFC.~Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340752|NCT03663231|BG000|Baseline|Biotene Then Placebo|"People who present with dry mouth and will receive a single dose of Biotene.~Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL."
11340753|NCT03663231|BG001|Baseline|Placebo Then Biotene|"People who present with dry mouth and will receive a single dose of an alternative agent.~Placebo: IND/IDE exempt device primarily water"
11340754|NCT03663231|BG002|Baseline|Total|Total of all reporting groups
11340755|NCT03663231|FG000|Participant Flow|Biotene Then Placebo|"People who present with dry mouth and will receive a single dose of Biotene.~Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL."
11340756|NCT03663231|FG001|Participant Flow|Placebo Then Biotene|"People who present with dry mouth and will receive a single dose of an alternative agent.~Placebo: IND/IDE exempt device primarily water"
11340757|NCT03663231|OG000|Outcome|Biotene|"People who present with dry mouth and will receive a single dose of Biotene.~Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL."
11340758|NCT03663231|OG001|Outcome|Placebo|"People who present with dry mouth and will receive a single dose of an alternative agent.~Placebo: IND/IDE exempt device primarily water"
11340759|NCT03663231|EG000|Reported Event|Biotene|"People who present with dry mouth and will receive a single dose of Biotene.~Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL."
11340760|NCT03663231|EG001|Reported Event|Placebo|"People who present with dry mouth and will receive a single dose of an alternative agent.~Placebo: IND/IDE exempt device primarily water"
11391152|NCT01772004|EG008|Reported Event|Primary Expansion Cohort: GC/GEJC Progressed|Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391153|NCT01772004|EG009|Reported Event|Primary Expansion Cohort: GC/GEJC Non Progressed|Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391154|NCT01772004|EG010|Reported Event|Secondary Expansion Cohort: Colorectal Cancer|Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391155|NCT01772004|EG011|Reported Event|Secondary Expansion Cohort: Castrate-resistant Prostate Cancer|Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391156|NCT01772004|EG012|Reported Event|Secondary Expansion Cohort: Adrenocortical Carcinoma|Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391157|NCT01772004|EG013|Reported Event|Secondary Expansion Cohort: Melanoma|Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391158|NCT01772004|EG014|Reported Event|Secondary Expansion Cohort: Mesothelioma|Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391159|NCT01772004|EG015|Reported Event|Secondary Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391160|NCT01772004|EG016|Reported Event|Secondary Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391161|NCT01772004|EG017|Reported Event|Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)|Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391162|NCT01772004|EG018|Reported Event|Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)|Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391163|NCT01772004|EG019|Reported Event|Efficacy Expansion Cohort: Ovarian Cancer|Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391164|NCT01772004|EG020|Reported Event|Efficacy Expansion Cohort: Urothelial Carcinoma|Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391165|NCT01772004|EG021|Reported Event|Efficacy Expansion Cohort: GC/GEJC, Third Line|Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391166|NCT01772004|EG022|Reported Event|Efficacy Expansion Cohort: HNSCC|Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
11391167|NCT01322971|BG000|Baseline|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
11391168|NCT01322971|BG001|Baseline|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
11391169|NCT01322971|BG002|Baseline|Total|Total of all reporting groups
11391170|NCT01322971|FG000|Participant Flow|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
11391171|NCT01322971|FG001|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
11391172|NCT01322971|OG000|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
11391173|NCT01322971|OG001|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
11391174|NCT01322971|EG000|Reported Event|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
11391175|NCT01322971|EG001|Reported Event|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
11391176|NCT01285102|BG000|Baseline|DEBIRI With Hepatic Artery Embolization|Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
11391177|NCT01285102|FG000|Participant Flow|DEBIRI With Hepatic Artery Embolization|Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
11391178|NCT01285102|OG000|Outcome|DEBIRI With Hepatic Artery Embolization|Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
11391179|NCT01285102|EG000|Reported Event|DEBIRI With Hepatic Artery Embolization|Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
11391180|NCT00952692|BG000|Baseline|dHER2 + AS15 ASCI + Lapatinib|Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
11391181|NCT00952692|FG000|Participant Flow|dHER2 + AS15 ASCI + Lapatinib|Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
11391182|NCT00952692|OG000|Outcome|dHER2 + AS15 ASCI + Lapatinib|Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
11391183|NCT00952692|EG000|Reported Event|dHER2 + AS15 ASCI + Lapatinib|Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
11391184|NCT00804713|BG000|Baseline|All Study Participants|Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
11391185|NCT00804713|FG000|Participant Flow|All Study Participants|Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
11391186|NCT00804713|OG000|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
11391187|NCT00804713|OG000|Outcome|QFT-GIT|"Subjects administered the QFT-GIT TB test~QFT-GIT: Perform QFT-GIT TB test"
11391188|NCT00804713|OG000|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
11391189|NCT00804713|EG000|Reported Event|All Study Participants|Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
11391190|NCT00677560|BG000|Baseline|Normal Subjects|This group consisted of 29 never-smokers with no history of respiratory disease
11391191|NCT00677560|BG001|Baseline|Healthy Smokers|The healthy smoking group consisted of 20 current smokers with no history of respiratory disease
11391192|NCT00677560|BG002|Baseline|Mild-moderate Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391193|NCT00677560|BG003|Baseline|Severe Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391194|NCT00677560|BG004|Baseline|COPD (Gold Stage I - III)|COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
11391195|NCT00677560|BG005|Baseline|Total|Total of all reporting groups
11391196|NCT00677560|FG000|Participant Flow|Mild-moderate Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391197|NCT00677560|FG001|Participant Flow|Severe Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391198|NCT00677560|FG002|Participant Flow|Normal Subjects|This group consisted of 29 never-smokers with no history of respiratory disease.
11391199|NCT00677560|FG003|Participant Flow|Healthy Smokers|Healthy smokers had no history of respiratory disease, and were all current smokers
11391200|NCT00677560|FG004|Participant Flow|COPD (Gold Stage I - III)|COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
11391201|NCT00677560|OG000|Outcome|Mild-moderate Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391202|NCT00677560|OG001|Outcome|Severe Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391203|NCT00677560|OG002|Outcome|Normal Subjects|This group consisted of 29 never-smokers with no history of respiratory disease
11391204|NCT00677560|OG003|Outcome|Healthy Smokers|The healthy smoking group consisted of 20 current smokers with no history of respiratory disease
11391205|NCT00677560|OG004|Outcome|COPD (Gold Stage I-III)|COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
11391206|NCT00677560|OG004|Outcome|COPD (Gold Stage I - III)|COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
11391207|NCT00677560|OG002|Outcome|Normal Subjects|This group consisted of 29 never-smokers with no history of respiratory disease.
11391208|NCT00677560|OG004|Outcome|COPD (Gold Stage I - III)|1357
11391209|NCT00677560|OG000|Outcome|Normal Subjects|This group consisted of 29 never-smokers with no history of respiratory disease
11391210|NCT00677560|OG001|Outcome|Healthy Smokers|The healthy smoking group consisted of 20 current smokers with no history of respiratory disease
11391211|NCT00677560|OG002|Outcome|Mild-moderate Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391212|NCT00677560|OG003|Outcome|Severe Asthma|Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).
11391213|NCT00677560|EG000|Reported Event|Mild-moderate Asthma|Mild-moderate asthma recruited at baseline
11391214|NCT00677560|EG001|Reported Event|Sever Asthma|Sever Asthma recruited at baseline
11391215|NCT00677560|EG002|Reported Event|Normal Subjects|Normal subjects at baseline
11391216|NCT00677560|EG003|Reported Event|Healthy Smokers|Healthy smokers at baseline
11391217|NCT00677560|EG004|Reported Event|COPD (Gold Stage I - III)|COPD (Gold stage I - III) baseline
11391218|NCT00389649|BG000|Baseline|60,75,90|HR set at 60 for 1 month, then 75, then 90
11391219|NCT00389649|BG001|Baseline|60,90,75|HR set at 60 for 1 month, then 90, then 60
11391220|NCT00389649|BG002|Baseline|75, 60, 90|HR set at 75 for 1 month, then 60, then 90
11391221|NCT00389649|BG003|Baseline|75, 90, 60|HR set at 75 for 1 month, then 90, then 60
11391222|NCT00389649|BG004|Baseline|90, 60, 75|HR set at 90 for 1 month, then 60, then 75
11391223|NCT00389649|BG005|Baseline|90, 75,60|HR set at 90 for 1 month, then 75, then 60
11391224|NCT00389649|BG006|Baseline|Total|Total of all reporting groups
11391225|NCT00389649|FG000|Participant Flow|60, 75, 90|Pacemaker set at HR=60 for 1 month, 75 for 1 month and 90 for 1 month
11391226|NCT00389649|FG001|Participant Flow|60, 90, 75|HR=60 for 1 month, 90 for 1 month and 75 for 1 month
11391227|NCT00389649|FG002|Participant Flow|75, 60, 90|HR=75 for 1 month, 60 for 1 month and 90 for 1 month
11391228|NCT00389649|FG003|Participant Flow|75, 90, 60|HR=75 for 1 month, 90 for 1 month and 60 for 1 month
11391229|NCT00389649|FG004|Participant Flow|90, 60, 75|HR=90 for 1 month, 60 for 1 month and 75 for 1 month
11391230|NCT00389649|FG005|Participant Flow|90, 75, 60|HR=90 for 1 month, 75 for 1 month and 60 for 1 month
11391231|NCT00389649|OG000|Outcome|HR=60|"Pacemaker set at 60~heart rate setting"
11391232|NCT00389649|OG001|Outcome|HR=75|"Pacemaker set at 75~heart rate setting"
11391233|NCT00389649|OG002|Outcome|HR=90|"Pacemaker set at 90~heart rate setting"
11391234|NCT00389649|EG000|Reported Event|HR=60|"Pacemaker set at 60~heart rate setting"
11391235|NCT00389649|EG001|Reported Event|HR=75|"Pacemaker set at 75~heart rate setting"
11391236|NCT00389649|EG002|Reported Event|HR=90|"Pacemaker set at 90~heart rate setting"
11391237|NCT04644328|BG000|Baseline|High-Intensity Counties|"Treatment: Individuals received approximately 3 Facebook ads over a 2-week period. Each ad contained a short video recorded by a physician using a script that discusses the importance of staying safe during Thanksgiving or Christmas by considering not traveling and using a mask when appropriate.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391238|NCT04644328|BG001|Baseline|Low-Intensity Counties|"Control: Individuals did not receive ads containing short physician-recorded videos.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391239|NCT04644328|BG002|Baseline|Total|Total of all reporting groups
11391240|NCT04644328|FG000|Participant Flow|High-Intensity Counties|"Treatment: Individuals received approximately 3 Facebook ads over a 2-week period. Each ad contained a short video recorded by a physician using a script that discusses the importance of staying safe during Thanksgiving or Christmas by considering not traveling and using a mask when appropriate.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391241|NCT04644328|FG001|Participant Flow|Low-Intensity Counties|"Control: Individuals did not receive ads containing short physician-recorded videos.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391242|NCT04644328|OG000|Outcome|High-Intensity Counties|"Treatment: Individuals received approximately 3 Facebook ads over a 2-week period. Each ad contained a short video recorded by a physician using a script that discusses the importance of staying safe during Thanksgiving or Christmas by considering not traveling and using a mask when appropriate.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391243|NCT04644328|OG001|Outcome|Low-Intensity Counties|"Control: Individuals did not receive ads containing short physician-recorded videos.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391244|NCT04644328|OG000|Outcome|Treatment ZCTAs|"Treatment: Individuals received approximately 3 Facebook ads over a 2-week period. Each ad contained a short video recorded by a physician using a script that discusses the importance of staying safe during Thanksgiving or Christmas by considering not traveling and using a mask when appropriate.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391245|NCT04644328|OG001|Outcome|Control ZCTAs|"Control: Individuals did not receive ads containing short physician-recorded videos.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391246|NCT04644328|EG000|Reported Event|High-Intensity Counties|"Treatment: Individuals received approximately 3 Facebook ads over a 2-week period. Each ad contained a short video recorded by a physician using a script that discusses the importance of staying safe during Thanksgiving or Christmas by considering not traveling and using a mask when appropriate.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391247|NCT04644328|EG001|Reported Event|Low-Intensity Counties|"Control: Individuals did not receive ads containing short physician-recorded videos.~Randomization to treatment: The investigators randomized exposure to the ad campaign as follows. The 13 states which centrally report COVID-19 cases at the ZCTA level contained 829 counties. At Thanksgiving, 9 counties were excluded due to data limitations; at Christmas, 62 counties were excluded due to data limitations and potential negative impacts of treatment in rural, conservative areas resulting from polarization in the wake of the 2020 presidential election. Approximately half of the counties were randomized to high-intensity treatment with the remaining randomized to low-intensity treatment. In high-intensity counties, 3/4 of ZCTAs were treated (i.e., Facebook users in those ZCTAs received ads) and 1/4 were not. In low-intensity counties, 1/4 of ZCTAs were treated and 3/4 were not."
11391248|NCT04246554|BG000|Baseline|Control|"Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery~Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control"
11391249|NCT04246554|BG001|Baseline|Ketorolac|"Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control~Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery"
11391250|NCT04246554|BG002|Baseline|Total|Total of all reporting groups
11391251|NCT04246554|FG000|Participant Flow|Control|"Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery~Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control"
11391252|NCT04246554|FG001|Participant Flow|Ketorolac|"Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control~Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery"
11391253|NCT04246554|OG000|Outcome|Control|"Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery~Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control"
11391254|NCT04246554|OG001|Outcome|Ketorolac|"Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control~Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery"
11391255|NCT04246554|EG000|Reported Event|Control|"Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery~Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control"
11391256|NCT04246554|EG001|Reported Event|Ketorolac|"Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control~Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery"
11391257|NCT03877926|BG000|Baseline|AV7909 Lot 1|Eligible participants randomized to receive AV7909 Lot 1.
11391258|NCT03877926|BG001|Baseline|AV7909 Lot 2|Eligible participants randomized to receive AV7909 Lot 2.
11391259|NCT03877926|BG002|Baseline|AV7909 Lot 3|Eligible participants randomized to receive AV7909 Lot 3.
11391260|NCT03877926|BG003|Baseline|BioThrax|Eligible participants randomized to receive BioThrax vaccine.
11391261|NCT03877926|BG004|Baseline|Total|Total of all reporting groups
11391262|NCT03877926|FG000|Participant Flow|AV7909 Lot 1|"Eligible participants randomized to receive AV7909 Lot 1.~AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant."
11391263|NCT03877926|FG001|Participant Flow|AV7909 Lot 2|"Eligible participants randomized to receive AV7909 Lot 2.~AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant."
11391264|NCT03877926|FG002|Participant Flow|AV7909 Lot 3|"Eligible participants randomized to receive AV7909 Lot 3.~AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant."
11391265|NCT03877926|FG003|Participant Flow|BioThrax|"Eligible participants randomized to receive BioThrax vaccine.~BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease."
11391266|NCT03877926|OG000|Outcome|AV7909 Lot 1|Eligible participants who received AV7909 vaccine lot 1.
11391267|NCT03877926|OG001|Outcome|AV7909 Lot 2|Eligible participants who received AV7909 vaccine lot 2.
11391268|NCT03877926|OG002|Outcome|AV7909 Lot 3|Eligible participants who received AV7909 vaccine lot 3.
11391269|NCT03877926|OG003|Outcome|BioThrax|Eligible participants who received BioThrax vaccine.
11391270|NCT03877926|OG000|Outcome|Pooled AV7909|Participants from groups 1-3 [.e., AV7909 Lot 1 (group 1), AV7909 Lot 2 (group 2) and AV7909 Lot 3 (group 3)] were pooled to assess TNA NF50 response at Day 64.
11391271|NCT03877926|OG000|Outcome|AV7909 Lot 1|Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.29 at Day 64.
11391272|NCT03877926|OG001|Outcome|AV7909 Lot 2|Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.29 at Day 64.
11391273|NCT03877926|OG002|Outcome|AV7909 Lot 3|Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.29 at Day 64.
11391274|NCT03877926|OG003|Outcome|BioThrax|Eligible participants who received BioThrax vaccine and achieved TNA NF50 ≥0.29 at Day 64.
11391275|NCT03877926|OG000|Outcome|AV7909 Lot 1|Eligible participants who received at least one dose of AV7909 Lot 1.
11197865|NCT02174562|EG000|Reported Event|Primary Care-Occupational Therapy|"PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).~Primary Care-Occupational Therapy: PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet)."
11391276|NCT03877926|OG001|Outcome|AV7909 Lot 2|Eligible participants who received at least one dose of AV7909 Lot 2.
11391277|NCT03877926|OG002|Outcome|AV7909 Lot 3|Eligible participants who received at least one dose of AV7909 Lot 3.
11391278|NCT03877926|OG003|Outcome|BioThrax|Eligible participants who received at least one dose of BioThrax vaccine.
11391279|NCT03877926|OG000|Outcome|AV7909 Lot 1|Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
11391280|NCT03877926|OG001|Outcome|AV7909 Lot 2|Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
11391281|NCT03877926|OG002|Outcome|AV7909 Lot 3|Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
11391282|NCT03877926|OG003|Outcome|BioThrax|Eligible participants randomized to receive BioThrax vaccine.
11391283|NCT03877926|EG000|Reported Event|AV7909 Lot 1|Eligible participants who received at least one dose of AV7909 Lot 1.
11391284|NCT03877926|EG001|Reported Event|AV7909 Lot 2|Eligible participants who received at least one dose of AV7909 Lot 2.
11391285|NCT03877926|EG002|Reported Event|AV7909 Lot 3|Eligible participants who received at least one dose of AV7909 Lot 3.
11391286|NCT03877926|EG003|Reported Event|BioThrax|Eligible participants who received at least one dose of BioThrax vaccine.
11391287|NCT03862807|BG000|Baseline|Patisiran|Participants received patisiran 0.3 milligrams/kilogram (mg/kg) via intravenous (IV) infusion once every 3 weeks (q3w) for 12 months. Dosing was based on actual body weight. For participants weighing 100 kg or more, patisiran was administered at a total dose of 30 mg IV q3w.
11391288|NCT03862807|FG000|Participant Flow|Patisiran|Participants received patisiran 0.3 milligrams/kilogram (mg/kg) via intravenous (IV) infusion once every 3 weeks (q3w) for 12 months. Dosing was based on actual body weight. For participants weighing 100 kg or more, patisiran was administered at a total dose of 30 mg IV q3w.
11391289|NCT03862807|OG000|Outcome|Patisiran|Participants received patisiran 0.3 milligrams/kilogram (mg/kg) via intravenous (IV) infusion once every 3 weeks (q3w) for 12 months. Dosing was based on actual body weight. For participants weighing 100 kg or more, patisiran was administered at a total dose of 30 mg IV q3w.
11391290|NCT03862807|EG000|Reported Event|Patisiran|Participants received patisiran 0.3 milligrams/kilogram (mg/kg) via intravenous (IV) infusion once every 3 weeks (q3w) for 12 months. Dosing was based on actual body weight. For participants weighing 100 kg or more, patisiran was administered at a total dose of 30 mg IV q3w.
11391291|NCT03857867|BG000|Baseline|Tactile Stimulation Glove|Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months.
11391292|NCT03857867|FG000|Participant Flow|Tactile Stimulation Glove|Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months. The glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
11391293|NCT03857867|OG000|Outcome|Tactile Stimulation Glove|Patients receive Tactile Stimulation for 3 months
11391294|NCT03857867|OG000|Outcome|Tactile Stimulation Glove|"Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months~Tactile Stimulation Glove: A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients."
11391295|NCT03857867|EG000|Reported Event|Tactile Stimulation Glove|Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months.
11391296|NCT03691571|BG000|Baseline|Esophageal Cooling|"Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).~Esophageal Cooling: The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage."
11391297|NCT03691571|BG001|Baseline|Control|"Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).~Control: Standard of care involves standard temperature probe monitoring."
11391298|NCT03691571|BG002|Baseline|Total|Total of all reporting groups
11391299|NCT03691571|FG000|Participant Flow|Esophageal Cooling|"Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).~Esophageal Cooling: The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage."
11391300|NCT03691571|FG001|Participant Flow|Control|"Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).~Control: Standard of care involves standard temperature probe monitoring."
11391301|NCT03691571|OG000|Outcome|Esophageal Cooling|"Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).~Esophageal Cooling: The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage."
11391302|NCT03691571|OG001|Outcome|Control|"Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).~Control: Standard of care involves standard temperature probe monitoring."
11391303|NCT03691571|OG002|Outcome|Total|Total number of participants with esophageal thermal injury
11391304|NCT03691571|EG000|Reported Event|Esophageal Cooling|"Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).~Esophageal Cooling: The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage."
11391305|NCT03691571|EG001|Reported Event|Control|"Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).~Control: Standard of care involves standard temperature probe monitoring."
11391306|NCT03436199|BG000|Baseline|ADS-5102 137 mg|ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
11391307|NCT03436199|BG001|Baseline|ADS-5102 274 mg|ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
11391308|NCT03436199|BG002|Baseline|Placebo|"placebo capsules~Placebo: Oral capsules to be administered once daily at bedtime"
11391309|NCT03436199|BG003|Baseline|Total|Total of all reporting groups
11391310|NCT03436199|FG000|Participant Flow|ADS-5102 137 mg|ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
11391311|NCT03436199|FG001|Participant Flow|ADS-5102 274 mg|ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
11391312|NCT03436199|FG002|Participant Flow|Placebo|"placebo capsules~Placebo: Oral capsules to be administered once daily at bedtime"
11391313|NCT03436199|OG000|Outcome|ADS-5102 137 mg|ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
11391314|NCT03436199|OG001|Outcome|ADS-5102 274 mg|ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
11391315|NCT03436199|OG002|Outcome|Placebo|"placebo capsules~Placebo: Oral capsules to be administered once daily at bedtime"
11391316|NCT03436199|EG000|Reported Event|ADS-5102 137 mg|ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
11391317|NCT03436199|EG001|Reported Event|ADS-5102 274 mg|ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
11391318|NCT03436199|EG002|Reported Event|Placebo|"placebo capsules~Placebo: Oral capsules to be administered once daily at bedtime"
11391319|NCT03353233|BG000|Baseline|iPACK Block Group|"A nerve block technique using a numbing medication called ropivacaine.~Ropivacaine: Local anesthetic (numbing drug)~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee."
11391320|NCT03353233|BG001|Baseline|Sham Group|"The same nerve block technique as above, however using an inactive solution of salt water.~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.~Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water."
11391321|NCT03353233|BG002|Baseline|Total|Total of all reporting groups
11391322|NCT03353233|FG000|Participant Flow|iPACK Block Group|"A nerve block technique using a numbing medication called ropivacaine.~Ropivacaine: Local anesthetic (numbing drug)~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee."
11391323|NCT03353233|FG001|Participant Flow|Sham Group|"The same nerve block technique as above, however using an inactive solution of salt water.~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.~Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water."
11391324|NCT03353233|OG000|Outcome|iPACK Block Group|"A nerve block technique using a numbing medication called ropivacaine.~Ropivacaine: Local anesthetic (numbing drug)~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee."
11391325|NCT03353233|OG001|Outcome|Sham Group|"The same nerve block technique as above, however using an inactive solution of salt water.~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.~Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water."
11391326|NCT03353233|EG000|Reported Event|iPACK Block Group|"A nerve block technique using a numbing medication called ropivacaine.~Ropivacaine: Local anesthetic (numbing drug)~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee."
11391327|NCT03353233|EG001|Reported Event|Sham Group|"The same nerve block technique as above, however using an inactive solution of salt water.~Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.~Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water."
11391328|NCT03250273|BG000|Baseline|Arm A - Cholangiocarcinoma|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391329|NCT03250273|BG001|Baseline|ARM B - Pancreatic Cancer|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391330|NCT03250273|BG002|Baseline|Total|Total of all reporting groups
11391331|NCT03250273|FG000|Participant Flow|Arm A - Cholangiocarcinoma|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391332|NCT03250273|FG001|Participant Flow|ARM B - Pancreatic Cancer|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391333|NCT03250273|OG000|Outcome|Arm A - Cholangiocarcinoma|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391334|NCT03250273|OG001|Outcome|ARM B - Pancreatic Cancer|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
10800139|NCT02527434|EG003|Reported Event|UBC - COMBO|Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
11197866|NCT02174562|EG001|Reported Event|Enhanced Usual Care|"Usual care enhanced with education and controls for attention~Enhanced Usual Care: Usual care enhanced with education and attention"
11391335|NCT03250273|EG000|Reported Event|Arm A - Cholangiocarcinoma|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391336|NCT03250273|EG001|Reported Event|ARM B - Pancreatic Cancer|"Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle)."
11391337|NCT03217136|BG000|Baseline|Ceftolozane/Tazobactam + Metronidazole|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose), plus metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 hours for 5 to 14 days.
11391338|NCT03217136|BG001|Baseline|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for metronidazole administered IV every 8 hours for 5 to 14 days.
11391339|NCT03217136|BG002|Baseline|Total|Total of all reporting groups
11391340|NCT03217136|FG000|Participant Flow|Ceftolozane/Tazobactam + Metronidazole|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose), plus metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 hours for 5 to 14 days.
11391341|NCT03217136|FG001|Participant Flow|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for metronidazole administered IV every 8 hours for 5 to 14 days.
11241590|NCT02487966|OG001|Outcome|Active tDCS and Sham Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241591|NCT02487966|OG002|Outcome|Sham tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation."
11241592|NCT02487966|OG003|Outcome|Sham tDCS and Sham Mirrory Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241593|NCT02487966|EG000|Reported Event|Active tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist."
11241594|NCT02487966|EG001|Reported Event|Active tDCS and Sham Mirror Therapy|"Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241595|NCT02487966|EG002|Reported Event|Sham tDCS and Active Mirror Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.~Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation."
11338402|NCT03609658|FG000|Participant Flow|Nurse Navigator Pathway Group|"Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)~Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."
11391342|NCT03217136|OG000|Outcome|Ceftolozane/Tazobactam + Metronidazole|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose), plus metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 hours for 5 to 14 days.
11391343|NCT03217136|OG001|Outcome|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for metronidazole administered IV every 8 hours for 5 to 14 days.
11391344|NCT03217136|EG000|Reported Event|Ceftolozane/Tazobactam + Metronidazole|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose), plus metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 hours for 5 to 14 days.
11391345|NCT03217136|EG001|Reported Event|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for metronidazole administered IV every 8 hours for 5 to 14 days.
11391346|NCT03181542|BG000|Baseline|Infrared Vein Illumination|"Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line~Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device."
11391347|NCT03181542|BG001|Baseline|Standard Technique|Standard vein location techniques will be used when inserting an intravenous access line
11391348|NCT03181542|BG002|Baseline|Total|Total of all reporting groups
11391349|NCT03181542|FG000|Participant Flow|Infrared Vein Illumination|"Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line~Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device."
11391350|NCT03181542|FG001|Participant Flow|Standard Technique|Standard vein location techniques will be used when inserting an intravenous access line
10800140|NCT02527434|EG004|Reported Event|TNBC - COMBO|Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
11243311|NCT02502149|FG002|Participant Flow|15K rFVIIIFc (6000 IU/Vial Strength) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with15K rFVIIIFc, participants will be re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants will resume to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11391351|NCT03181542|OG000|Outcome|Infrared Vein Illumination|"Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line~Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device."
11391352|NCT03181542|OG001|Outcome|Standard Technique|Standard vein location techniques will be used when inserting an intravenous access line
11391353|NCT03181542|EG000|Reported Event|Infrared Vein Illumination|"Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line~Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device."
11391354|NCT03181542|EG001|Reported Event|Standard Technique|Standard vein location techniques will be used when inserting an intravenous access line
11241596|NCT02487966|EG003|Reported Event|Sham tDCS and Sham Mirrory Therapy|"Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.~transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.~Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities."
11241597|NCT02488005|BG000|Baseline|Small Bowel Ultrasound|Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
11241598|NCT02488005|FG000|Participant Flow|Small Bowel Ultrasound|Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
11241599|NCT02488005|OG000|Outcome|Small Bowel Ultrasound|Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
11241600|NCT02488005|EG000|Reported Event|Small Bowel Ultrasound|Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.
11241601|NCT02488018|BG000|Baseline|Provision of Experimental Honeys|Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
11241602|NCT02488018|FG000|Participant Flow|Honey Glycemic Index|"Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.~Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
11241603|NCT02488018|OG000|Outcome|Provision of Experimental Honeys|"Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.~25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
11241604|NCT02488018|EG000|Reported Event|Honey Glycemic Index|Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.
11241605|NCT02488070|BG000|Baseline|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11241606|NCT02488070|FG000|Participant Flow|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Undergo PET/CT~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV~Laboratory Biomarker Analysis: Correlative studies~Magnetic Resonance Imaging: Undergo PET/MRI~Positron Emission Tomography: Undergo PET/CT~Positron Emission Tomography: Undergo PET/MRI"
11241607|NCT02488070|OG000|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11241608|NCT02488070|OG000|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
11241609|NCT02488070|EG000|Reported Event|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11241610|NCT02488109|BG000|Baseline|Higher Calorie Refeeding (HCR) Protocol|Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal
11241611|NCT02488109|BG001|Baseline|Lower Calorie Refeeding (LCR) Protocol|Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal
11241612|NCT02488109|BG002|Baseline|Total|Total of all reporting groups
11241613|NCT02488109|FG000|Participant Flow|Higher Calorie Refeeding (HCR) Protocol|Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal
11241614|NCT02488109|FG001|Participant Flow|Lower Calorie Refeeding (LCR) Protocol|Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal
11241615|NCT02488109|OG000|Outcome|Higher Calorie Refeeding (HCR) Protocol|Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal
11391355|NCT04458467|BG000|Baseline|Continuous Infusion|"Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).~Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room."
11391356|NCT04458467|BG001|Baseline|Automated Boluses|"Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).~Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours)."
11391357|NCT04458467|BG002|Baseline|Total|Total of all reporting groups
11391358|NCT04458467|FG000|Participant Flow|Continuous Infusion|"Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).~Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room."
11391359|NCT04458467|FG001|Participant Flow|Automated Boluses|"Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).~Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours)."
11391360|NCT04458467|OG000|Outcome|Continuous Infusion|"Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).~Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room."
11391361|NCT04458467|OG001|Outcome|Automated Boluses|"Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).~Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours)."
11391362|NCT04458467|EG000|Reported Event|Continuous Infusion|"Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).~Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room."
11391363|NCT04458467|EG001|Reported Event|Automated Boluses|"Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).~Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours)."
11241616|NCT02488109|OG001|Outcome|Lower Calorie Refeeding (LCR) Protocol|Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal
11241617|NCT02488109|OG000|Outcome|Higher Calorie Refeeding (HCR)|Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal
11391364|NCT04411082|BG000|Baseline|TDT High Dose|TDT High dose
11391365|NCT04411082|BG001|Baseline|TDT Low Dose|TDT Low dose
11391366|NCT04411082|BG002|Baseline|TDT Placebo|TDT Placebo
11391367|NCT04411082|BG003|Baseline|NTDT High Dose|NTDT High dose
11391368|NCT04411082|BG004|Baseline|NTDT Low Dose|NTDT Low dose
11391369|NCT04411082|BG005|Baseline|NTDT Placebo|NTDT Placebo
11391370|NCT04411082|BG006|Baseline|Total|Total of all reporting groups
11391371|NCT04411082|FG000|Participant Flow|TDT High Dose|TDT High dose
11391372|NCT04411082|FG001|Participant Flow|TDT Low Dose|TDT Low dose
11391373|NCT04411082|FG002|Participant Flow|TDT Placebo|TDT Placebo
11391374|NCT04411082|FG003|Participant Flow|NTDT High Dose|NTDT High dose
11391375|NCT04411082|FG004|Participant Flow|NTDT Low Dose|NTDT Low dose
11391376|NCT04411082|FG005|Participant Flow|NTDT Placebo|NTDT Placebo
11391377|NCT04411082|OG000|Outcome|TDT High Dose|TDT High dose
11391378|NCT04411082|OG001|Outcome|TDT Low Dose|TDT Low dose
11391379|NCT04411082|OG002|Outcome|TDT Placebo|TDT Placebo
11391380|NCT04411082|OG003|Outcome|NTDT High Dose|NTDT High dose
11391381|NCT04411082|OG004|Outcome|NTDT Low Dose|NTDT Low dose
11391382|NCT04411082|OG005|Outcome|NTDT Placebo|NTDT Placebo
11391383|NCT04411082|OG000|Outcome|NTDT High Dose|NTDT High dose
11391384|NCT04411082|OG001|Outcome|NTDT Low Dose|NTDT Low dose
11391385|NCT04411082|OG002|Outcome|NTDT Placebo|NTDT Placebo
11391386|NCT04411082|EG000|Reported Event|TDT High Dose|TDT High dose
11391387|NCT04411082|EG001|Reported Event|TDT Low Dose|TDT Low dose
11391388|NCT04411082|EG002|Reported Event|TDT Placebo|TDT Placebo
11391389|NCT04411082|EG003|Reported Event|NTDT High Dose|NTDT High dose
11391390|NCT04411082|EG004|Reported Event|NTDT Low Dose|NTDT Low dose
11391391|NCT04411082|EG005|Reported Event|NTDT Placebo|NTDT Placebo
11391392|NCT04100590|BG000|Baseline|Cannabis|"In this session, the participant will smoke two-thirds of one cannabis cigarette (7% THC or 0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)"
11241618|NCT02488109|OG001|Outcome|Lower Calorie Refeeding (LCR)|Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal
11241619|NCT02488109|EG000|Reported Event|Higher Calorie Refeeding (HCR)|Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal
11241620|NCT02488109|EG001|Reported Event|Lower Calorie Refeeding (LCR)|Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal. Of the 56 participants originally randomized to this treatment, 5 never received treatment and were therefore excluded from mITT analyses.
11241621|NCT02488239|BG000|Baseline|Actively Enrolled Patients|Patients actively enrolled and implanted with a 3-lead CRT-P system.
11241622|NCT02488239|FG000|Participant Flow|Actively Enrolled Patients|Patients actively enrolled and implanted with a 3-lead CRT-P system.
11241623|NCT02488239|OG000|Outcome|Actively Enrolled Patients|Subjects actively enrolled and implanted with a 3-lead CRT-P system.
11241624|NCT02488239|OG000|Outcome|Actively Enrolled Patients|Patients actively enrolled and implanted with a 3-lead CRT-P system.
11241625|NCT02488239|EG000|Reported Event|Actively Enrolled Patients|Patients actively enrolled and implanted with a 3-lead CRT-P system.
11241626|NCT02488317|BG000|Baseline|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241627|NCT02488317|BG001|Baseline|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241628|NCT02488317|BG002|Baseline|Total|Total of all reporting groups
11241629|NCT02488317|FG000|Participant Flow|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241630|NCT02488317|FG001|Participant Flow|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241631|NCT02488317|OG000|Outcome|Intervention Pre-test|Intervention arm responses prior to accessing the decision aid (N=70)
11241632|NCT02488317|OG001|Outcome|Intervention Post-test|Intervention arm responses after accessing the decision aid (N=63)
11241633|NCT02488317|OG002|Outcome|Control|Control arm with no decision aid.
11241634|NCT02488317|OG000|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241635|NCT02488317|OG001|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241636|NCT02488317|OG000|Outcome|Intervention Post-test|Intervention arm after reviewing the decision aid
11241637|NCT02488317|EG000|Reported Event|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11243312|NCT02502149|FG003|Participant Flow|15K rFVIIIFc (1000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 1000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
11243313|NCT02502149|FG004|Participant Flow|15K rFVIIIFc (6000 IU/Vial Strength) (PK3)|Participants who were randomized to receive 15K rFVIIIFc 6000 IU/vial for PK2 assessment were re-evaluated after 13 weeks on treatment for PK3 assessment at same vial strength.
11391393|NCT04100590|FG000|Participant Flow|Cannabis|"In this session, the participant will smoke two-thirds of one cannabis cigarette (7% THC or 0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)"
11391394|NCT04100590|OG000|Outcome|Active Cannabis|"In this session, the participant will smoke two-thirds of one active cannabis cigarette (7% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)"
11391395|NCT04100590|OG001|Outcome|Placebo Cannabis|"In this session, the participant will smoke two-thirds of one inactive placebo cannabis cigarette (0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)"
11391396|NCT04100590|EG000|Reported Event|Active Cannabis|"In this session, the participant will smoke two-thirds of one cannabis cigarette (7% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked active cannabis (7% THC)"
11391397|NCT04100590|EG001|Reported Event|Inactive Cannabis|"In this session, the participant will smoke two-thirds of one placebo cannabis cigarette (0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.~Cannabis: Smoked placebo cannabis (0% THC)"
11391398|NCT03985293|BG000|Baseline|Placebo|Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391399|NCT03985293|BG001|Baseline|PF-06882961 2.5mg BID|PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391400|NCT03985293|BG002|Baseline|PF-06882961 10mg BID|PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391401|NCT03985293|BG003|Baseline|PF-06882961 40mg BID|PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391402|NCT03985293|BG004|Baseline|PF-06882961 80mg BID|PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391403|NCT03985293|BG005|Baseline|PF-06882961 120mg BID|PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391404|NCT03985293|BG006|Baseline|Total|Total of all reporting groups
11391405|NCT03985293|FG000|Participant Flow|Placebo|Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391406|NCT03985293|FG001|Participant Flow|PF-06882961 2.5mg BID|PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391407|NCT03985293|FG002|Participant Flow|PF-06882961 10mg BID|PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391408|NCT03985293|FG003|Participant Flow|PF-06882961 40mg BID|PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391409|NCT03985293|FG004|Participant Flow|PF-06882961 80mg BID|PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391410|NCT03985293|FG005|Participant Flow|PF-06882961 120mg BID|PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391411|NCT03985293|OG000|Outcome|Placebo|Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391412|NCT03985293|OG001|Outcome|PF-06882961 2.5 BID|PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391413|NCT03985293|OG002|Outcome|PF-06882961 10 mg BID|PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391414|NCT03985293|OG003|Outcome|PF-06882961 40 mg BID|PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391415|NCT03985293|OG004|Outcome|PF-06882961 80 mg BID|PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391416|NCT03985293|OG005|Outcome|PF-06882961 120 mg BID|PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391417|NCT03985293|EG000|Reported Event|Placebo|Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391418|NCT03985293|EG001|Reported Event|PF-06882961 2.5mg BID|PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11241638|NCT02488317|EG001|Reported Event|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11241639|NCT02488330|BG000|Baseline|Control and/or Onartuzumab Treatment|Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).
11241640|NCT02488330|FG000|Participant Flow|Control and/or Onartuzumab Treatment|Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).
11241641|NCT02488330|OG000|Outcome|Control and/or Onartuzumab Treatment|Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).
11241642|NCT02488330|EG000|Reported Event|Control and/or Onartuzumab Treatment|Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).
11241643|NCT02488681|BG000|Baseline|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11241644|NCT02488681|FG000|Participant Flow|Micra Pacemaker Implant|Patients who underwent a Micra implant attempt
11241645|NCT02488681|OG000|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11241646|NCT02488681|EG000|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
11241647|NCT02488824|BG000|Baseline|Experimental: Warm Temperature Exposure in Tetraplegia|"Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241648|NCT02488824|BG001|Baseline|Active Comparator: Warm Temperature Exposure in Able-Bodied|"Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241649|NCT02488824|BG002|Baseline|Total|Total of all reporting groups
11241650|NCT02488824|FG000|Participant Flow|Experimental: Warm Temperature Exposure in Tetraplegia|"Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241651|NCT02488824|FG001|Participant Flow|Active Comparator: Warm Temperature Exposure in Able-Bodied|"Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241652|NCT02488824|OG000|Outcome|Experimental: Warm Temperature Exposure in Tetraplegia|"Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241653|NCT02488824|OG001|Outcome|Active Comparator: Warm Temperature Exposure in Able-Bodied|"Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241654|NCT02488824|EG000|Reported Event|Experimental: Warm Temperature Exposure in Tetraplegia|"Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11243314|NCT02502149|OG000|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|"All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).~."
11391419|NCT03985293|EG002|Reported Event|PF-06882961 10mg BID|PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
11391420|NCT03985293|EG003|Reported Event|PF-06882961 40mg BID|PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391421|NCT03985293|EG004|Reported Event|PF-06882961 80mg BID|PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391422|NCT03985293|EG005|Reported Event|PF-06882961 120mg BID|PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
11391423|NCT03846427|BG000|Baseline|Zanubrutinib|Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
11391424|NCT03846427|FG000|Participant Flow|Zanubrutinib|Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
11391425|NCT03846427|OG000|Outcome|Zanubrutinib|Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
11391426|NCT03846427|EG000|Reported Event|Zanubrutinib|Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
11391427|NCT03785340|BG000|Baseline|OCU-310|Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks
11391428|NCT03785340|BG001|Baseline|Placebo|Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
11391429|NCT03785340|BG002|Baseline|Total|Total of all reporting groups
11391430|NCT03785340|FG000|Participant Flow|OCU-310|Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks
11391431|NCT03785340|FG001|Participant Flow|Placebo|Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
11391432|NCT03785340|OG000|Outcome|OCU-310|Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks
11391433|NCT03785340|OG001|Outcome|Placebo|Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
11197867|NCT02174627|BG000|Baseline|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was 70 mg TIW and was titrated to achieve and maintain Hb 11±1 g/dL. Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11391434|NCT03785340|EG000|Reported Event|OCU-310|Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks
11391435|NCT03785340|EG001|Reported Event|Placebo|Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
11391436|NCT03776357|BG000|Baseline|Experimental|Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
11391437|NCT03776357|FG000|Participant Flow|Experimental|Participants utilize FDA cleared Virtual Exercise Rehabilitation Assistant (VERA™) platform during pre-operative visit to obtain functional outcome scores.
11391438|NCT03776357|OG000|Outcome|Experimental|Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
11391439|NCT03776357|EG000|Reported Event|Experimental|Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
11391440|NCT03656068|BG000|Baseline|NTZ 500 mg BID|Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks.
11391441|NCT03656068|FG000|Participant Flow|NTZ 500 mg BID|Open label group: all patients were to receive study drug Nitazoxanide (Alinia) 500 mg BID for 24 weeks.
11391442|NCT03656068|OG000|Outcome|NTZ 500 mg BID|Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks.
11391443|NCT03656068|EG000|Reported Event|NTZ 500 mg BID|Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks.
11391444|NCT03595982|BG000|Baseline|Procardia XL 30 mg|"Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.~Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h"
11391445|NCT03595982|BG001|Baseline|Procardia XL 60 mg|"Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.~Procardia XL 60Mg: Procardia XL 60 mg Q 24h"
11391446|NCT03595982|BG002|Baseline|Total|Total of all reporting groups
11391447|NCT03595982|FG000|Participant Flow|Procardia XL 30 mg|"Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.~Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h"
11391448|NCT03595982|FG001|Participant Flow|Procardia XL 60 mg|"Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.~Procardia XL 60Mg: Procardia XL 60 mg Q 24h"
11391449|NCT03595982|OG000|Outcome|Procardia XL 30 mg|"Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.~Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h"
11391450|NCT03595982|OG001|Outcome|Procardia XL 60 mg|"Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.~Procardia XL 60Mg: Procardia XL 60 mg Q 24h"
11391451|NCT03595982|EG000|Reported Event|Procardia XL 30 mg|"Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.~Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h"
11391452|NCT03595982|EG001|Reported Event|Procardia XL 60 mg|"Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.~Procardia XL 60Mg: Procardia XL 60 mg Q 24h"
11391453|NCT03400956|BG000|Baseline|Vilaprisan (A1)|Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391454|NCT03400956|BG001|Baseline|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391455|NCT03400956|BG002|Baseline|Vilaprisan+Placebo (B2)|Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391456|NCT03400956|BG003|Baseline|Total|Total of all reporting groups
11391457|NCT03400956|FG000|Participant Flow|Vilaprisan (A1)|Vilaprisan in treatment period (TP) 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391458|NCT03400956|FG001|Participant Flow|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391459|NCT03400956|FG002|Participant Flow|Vilaprisan+Placebo (B2)|Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391460|NCT03400956|OG000|Outcome|Vilaprisan (A1)|Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391461|NCT03400956|OG001|Outcome|Placebo+Vilaprisan (B1)|Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391462|NCT03400956|OG002|Outcome|Vilaprisan+Placebo (B2)|Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
11391463|NCT03400956|EG000|Reported Event|Vilaprisan (A1) - Treatment Emergent AEs|"Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that started from the first application of study medication up to 60 calendar days after end of treatment with study medication."
11391464|NCT03400956|EG001|Reported Event|Placebo+Vilaprisan (B1) - Treatment Emergent AEs|"Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that started from the first application of study medication up to 60 calendar days after end of treatment with study medication."
11197868|NCT02174627|BG001|Baseline|Placebo|Participants received placebo tablets orally TIW. Dosing instructions were matched to instructions provided for roxadustat (ie, initial dose matched to 70 mg TIW). Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11197869|NCT02174627|BG002|Baseline|Total|Total of all reporting groups
11197870|NCT02174627|FG000|Participant Flow|Roxadustat|Participants received roxadustat tablets orally three times a week (TIW). The initial dose was 70 milligram (mg) TIW and was titrated to achieve and maintain haemoglobin (Hb) 11±1 grams per deciliter (g/dL). Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11197871|NCT02174627|FG001|Participant Flow|Placebo|Participants received placebo tablets orally TIW. Dosing instructions were matched to instructions provided for roxadustat (ie, initial dose matched to 70 mg TIW). Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11197872|NCT02174627|OG000|Outcome|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was 70 mg TIW and was titrated to achieve and maintain Hb 11±1 g/dL. Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11197873|NCT02174627|OG001|Outcome|Placebo|Participants received placebo tablets orally TIW. Dosing instructions were matched to instructions provided for roxadustat (ie, initial dose matched to 70 mg TIW). Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11197874|NCT02174627|EG000|Reported Event|Roxadustat|Participants received roxadustat tablets orally TIW. The initial dose was 70 mg TIW and was titrated to achieve and maintain Hb 11±1 g/dL. Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11391465|NCT03400956|EG002|Reported Event|Vilaprisan +Placebo (B2) - Treatment Emergent AEs|"Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that started from the first application of study medication up to 60 calendar days after end of treatment with study medication."
11391466|NCT03400956|EG003|Reported Event|Vilaprisan (A1) - Post Treatment AEs|Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
11391467|NCT03400956|EG004|Reported Event|Placebo+Vilaprisan (B1) - Post Treatment AEs|Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
11391468|NCT03400956|EG005|Reported Event|Vilaprisan+Placebo (B2) - Post Treatment AEs|Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
11391469|NCT03338790|BG000|Baseline|Arm A1|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
11391470|NCT03338790|BG001|Baseline|Arm A2|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
11391471|NCT03338790|BG002|Baseline|Arm B|Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
11391472|NCT03338790|BG003|Baseline|Arm C|Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
11391473|NCT03338790|BG004|Baseline|Total|Total of all reporting groups
11391474|NCT03338790|FG000|Participant Flow|Arm A1|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
11391475|NCT03338790|FG001|Participant Flow|Arm A2|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
11391476|NCT03338790|FG002|Participant Flow|Arm B|Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
11391477|NCT03338790|FG003|Participant Flow|Arm C|Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
11391478|NCT03338790|OG000|Outcome|Arm A1|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
11197875|NCT02174627|EG001|Reported Event|Placebo|Participants received placebo tablets orally TIW. Dosing instructions were matched to instructions provided for roxadustat (ie, initial dose matched to 70 mg TIW). Treatment started on Day 1 and treatment duration was variable for individual participants (estimated up to 4 years). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks until Week 52, every 8 weeks thereafter using a dose adjustment algorithm; all dose adjustments were based on Hb values.
11391479|NCT03338790|OG001|Outcome|Arm A2|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have not received prior chemotherapy regimen
11391480|NCT03338790|OG002|Outcome|Arm B|Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
11391481|NCT03338790|OG003|Outcome|Arm C|Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
11391482|NCT03338790|EG000|Reported Event|Arm A1: Nivolumab 480 mg and Rucaparib 600 mg|Nivolumab 480 mg IV Q4W + Rucaparib 600 mg PO BID for participants who have at lease 1 but no more than 2 prior chemotherapy regimens
11391483|NCT03338790|EG001|Reported Event|Arm A2: Nivolumab 480 mg and Rucaparib 600 mg|Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
11391484|NCT03338790|EG002|Reported Event|Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2|Nivolumab 360 mg IV Q3W + Docetaxel 75 mg/m2 IV Q3W + Prednisone 5 mg PO BID
11391485|NCT03338790|EG003|Reported Event|Arm C: Nivolumab 480 mg and Enzalutamide 160 mg|Nivolumab 480 mg IV Q4W + Enzalutamide 160 mg PO QD
11391486|NCT03126539|BG000|Baseline|Group A: No UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391487|NCT03126539|BG001|Baseline|Group B With UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.~Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications"
11391488|NCT03126539|BG002|Baseline|Total|Total of all reporting groups
11391489|NCT03126539|FG000|Participant Flow|Group A: No UV Exposure - Sulforaphane|"One photoexposed site will be identified. 500nmol Sulforaphane in jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391490|NCT03126539|FG001|Participant Flow|Group A: No UV Exposure - Placebo|"One photoexposed site will be identified. Jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391491|NCT03126539|FG002|Participant Flow|Group A: No UV Exposure - No Treatment Control|"One photoprotected site and two photoexposed sites will be identified. No treatment will be administered at this site. A 4mm punch biopsy will be obtained from this site as a control.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391492|NCT03126539|FG003|Participant Flow|Group B With UV Exposure - Sulforaphane|One photoprotected site will be identified. 500nmol sulforaphane in jojoba oil will be applied topically to the site for up to 7 consecutive nights. Site will be exposed to UV. Biopsy of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and typically heals well without complications.
11391493|NCT03126539|FG004|Participant Flow|Group B With UV Exposure - Placebo|One photoprotected sites will be identified. Jojoba Oil will be applied topically to a single selected site for up to 7 consecutive nights. Site will be exposed to UV. Biopsies of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications.
11391494|NCT03126539|OG000|Outcome|Group A: No UV Exposure - Sulforaphane|"One photoexposed site will be identified. 500nmol Sulforaphane in jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391495|NCT03126539|OG001|Outcome|Group A: No UV Exposure - Placebo|"One photoexposed site will be identified. Jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11197876|NCT02174731|BG000|Baseline|Roxadustat|Participants received roxadustat tablets orally TIW throughout the treatment period (up to 4 years). For HD participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain Hb values of 11±1 g/dL. Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.
11197877|NCT02174731|BG001|Baseline|Epoetin Alfa|Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) SC or IV injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 IU/kg TIW. Dose adjustments were to be consistent with local approved prescribing information.
11391496|NCT03126539|OG002|Outcome|Group A: No UV Exposure - No Treatment Control|"One photoprotected site and two photoexposed sites will be identified. No treatment will be administered at this site. A 4mm punch biopsy will be obtained from this site as a control.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than five total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391497|NCT03126539|OG003|Outcome|Group B With UV Exposure - Sulforaphane|One photoprotected site will be identified. 500nmol sulforaphane in jojoba oil will be applied topically to the site for up to 7 consecutive nights. Site will be exposed to UV. Biopsy of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and typically heals well without complications.
11391498|NCT03126539|OG004|Outcome|Group B With UV Exposure - Placebo|One photoprotected sites will be identified. Jojoba Oil will be applied topically to a single selected site for up to 7 consecutive nights. Site will be exposed to UV. Biopsies of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications.
11391499|NCT03126539|OG000|Outcome|Group A: No UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391500|NCT03126539|OG001|Outcome|Group B With UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.~Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications"
11391501|NCT03126539|OG000|Outcome|Group A|"Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.~Sulforaphane: Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11391502|NCT03126539|OG001|Outcome|Group B|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.~Sulforaphane: Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.~Narrow-band Ultraviolet B exposure: The investigators will use a Lumera ultraviolet B (UVB) light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the c"
11391503|NCT03126539|EG000|Reported Event|Group A: No UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin."
11338403|NCT03609658|FG001|Participant Flow|Usual Care Group|"Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).~Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm."
11197878|NCT02174731|BG002|Baseline|Total|Total of all reporting groups
11338404|NCT03609658|OG000|Outcome|Nurse Navigator Pathway Group|"Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)~Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."
11338405|NCT03609658|OG001|Outcome|Usual Care Group|"Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).~Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm."
11338406|NCT03609658|EG000|Reported Event|Nurse Navigator Pathway Group|"Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)~Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."
11338407|NCT03609658|EG001|Reported Event|Usual Care Group|"Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).~Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm."
11338408|NCT03610048|BG000|Baseline|ALKS 5461|"All subjects assigned to ALKS 5461~Sublingual tablets~ALKS 5461: samidorphan + buprenorphine administered sublingually"
11338409|NCT03610048|FG000|Participant Flow|ALKS 5461|"All subjects assigned to ALKS 5461~Sublingual tablets~ALKS 5461: samidorphan + buprenorphine administered sublingually"
11338410|NCT03610048|OG000|Outcome|ALKS 5461|"All subjects assigned to ALKS 5461~Sublingual tablets~ALKS 5461: samidorphan + buprenorphine administered sublingually"
11338411|NCT03610048|EG000|Reported Event|ALKS 5461|"All subjects assigned to ALKS 5461~Sublingual tablets~ALKS 5461: samidorphan + buprenorphine administered sublingually"
11338412|NCT03610165|BG000|Baseline|Arterial Line - Control|"Arterial line waveform and pressure~Control: Arterial waveform and pressures"
11338413|NCT03610165|BG001|Baseline|Acumen HPI-enabled EV1000 Screen|"Arterial line waveform and pressure + HPI alert from EV1000 monitor~Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen."
11338414|NCT03610165|BG002|Baseline|Total|Total of all reporting groups
11338415|NCT03610165|FG000|Participant Flow|Arterial Line - Control|"Arterial line waveform and pressure~Control: Arterial waveform and pressures"
11338416|NCT03610165|FG001|Participant Flow|Acumen HPI-enabled EV1000 Screen|"Arterial line waveform and pressure + HPI alert from EV1000 monitor~Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen."
11338417|NCT03610165|OG000|Outcome|Arterial Line - Control|"Arterial line waveform and pressure~Control: Arterial waveform and pressures"
11338418|NCT03610165|OG001|Outcome|Acumen HPI-enabled EV1000 Screen|"Arterial line waveform and pressure + HPI alert from EV1000 monitor~Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen."
11338419|NCT03610165|EG000|Reported Event|Arterial Line - Control|"Arterial line waveform and pressure~Control: Arterial waveform and pressures"
11338420|NCT03610165|EG001|Reported Event|Acumen HPI-enabled EV1000 Screen|"Arterial line waveform and pressure + HPI alert from EV1000 monitor~Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen."
11338421|NCT03610269|BG000|Baseline|INVSENSOR00026|All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
11338422|NCT03610269|FG000|Participant Flow|INVSENSOR00026|All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
11338423|NCT03610269|OG000|Outcome|INVSENSOR00026|All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
11338424|NCT03610269|EG000|Reported Event|INVSENSOR00026|All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
11338425|NCT03610399|BG000|Baseline|Primaquine Regular Dose Unsupervised|"This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy.~Primaquine: Different total dose and supervision."
11338426|NCT03610399|BG001|Baseline|Primaquine Regular Dose Supervised|"This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy.~Primaquine: Different total dose and supervision."
11338427|NCT03610399|BG002|Baseline|Primaquine Double Dose Unsupervised|"This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy.~Primaquine: Different total dose and supervision."
11338428|NCT03610399|BG003|Baseline|Total|Total of all reporting groups
11338429|NCT03610399|FG000|Participant Flow|Primaquine Regular Dose Unsupervised|"This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy.~Primaquine: Different total dose and supervision."
11338430|NCT03610399|FG001|Participant Flow|Primaquine Regular Dose Supervised|"This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy.~Primaquine: Different total dose and supervision."
11338431|NCT03610399|FG002|Participant Flow|Primaquine Double Dose Unsupervised|"This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy.~Primaquine: Different total dose and supervision."
11391504|NCT03126539|EG001|Reported Event|Group B With UV Exposure|"Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.~Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).~4 mm skin punch biopsy: All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications"
11391505|NCT03057613|BG000|Baseline|Pembrolizumab + Post Operative Radiotherapy|"IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks~Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion~IMRT 60-66Gy: 60-66Gy for 6 weeks"
11391506|NCT03057613|FG000|Participant Flow|Pembrolizumab + Post Operative Radiotherapy|"IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks~Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion~IMRT 60-66Gy: 60-66Gy for 6 weeks"
11391507|NCT03057613|OG000|Outcome|Pembrolizumab + Post Operative Radiotherapy|"IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks~Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion~IMRT 60-66Gy: 60-66Gy for 6 weeks"
11391508|NCT03057613|EG000|Reported Event|Pembrolizumab + Post Operative Radiotherapy|"IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks~Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion~IMRT 60-66Gy: 60-66Gy for 6 weeks"
11391509|NCT02898259|BG000|Baseline|DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391510|NCT02898259|BG001|Baseline|DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391511|NCT02898259|BG002|Baseline|DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391512|NCT02898259|BG003|Baseline|Expansion Cohort 1: Follicular Lymphoma at MTD|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391513|NCT02898259|BG004|Baseline|Expansion Cohort 2: Non-Follicular Lymphoma at MTD|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391514|NCT02898259|BG005|Baseline|Total|Total of all reporting groups
11391515|NCT02898259|FG000|Participant Flow|DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391516|NCT02898259|FG001|Participant Flow|DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391517|NCT02898259|FG002|Participant Flow|DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391518|NCT02898259|FG003|Participant Flow|Expansion Cohort I: Follicular Lymphoma at MTD|Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391519|NCT02898259|FG004|Participant Flow|Expansion Cohort 2: Non-Follicular Lymphoma at MTD|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391520|NCT02898259|OG000|Outcome|Lenalidomide + Ixazomib + Rituximab|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391521|NCT02898259|OG000|Outcome|DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391522|NCT02898259|OG001|Outcome|DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391523|NCT02898259|OG002|Outcome|DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391524|NCT02898259|OG003|Outcome|Expansion Cohort I: Follicular Lymphoma at MTD|Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391525|NCT02898259|OG004|Outcome|Expansion Cohort 2: Non-Follicular Lymphoma at MTD|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391526|NCT02898259|EG000|Reported Event|DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11241655|NCT02488824|EG001|Reported Event|Active Comparator: Warm Temperature Exposure in Able-Bodied|"Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance~Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort)."
11241656|NCT02488915|BG000|Baseline|EmboTrap® Revascularization Device|"Mechanical Thrombectomy with EmboTrap~EmboTrap® Revascularization Device"
11241657|NCT02488915|FG000|Participant Flow|EmboTrap® Revascularization Device|"Mechanical Thrombectomy with EmboTrap~EmboTrap® Revascularization Device"
11241658|NCT02488915|OG000|Outcome|EmboTrap® Revascularization Device|"Mechanical Thrombectomy with EmboTrap~EmboTrap® Revascularization Device"
11241659|NCT02488915|EG000|Reported Event|EmboTrap® Revascularization Device|"Mechanical Thrombectomy with EmboTrap~EmboTrap® Revascularization Device"
11241660|NCT02488980|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11241661|NCT02488980|BG001|Baseline|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11241662|NCT02488980|BG002|Baseline|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11241663|NCT02488980|BG003|Baseline|Total|Total of all reporting groups
11241664|NCT02488980|FG000|Participant Flow|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11241665|NCT02488980|FG001|Participant Flow|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11241666|NCT02488980|FG002|Participant Flow|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11241667|NCT02488980|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11241668|NCT02488980|OG001|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11241669|NCT02488980|OG002|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11241670|NCT02488980|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11241671|NCT02488980|EG001|Reported Event|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11241672|NCT02488980|EG002|Reported Event|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11241673|NCT02489045|BG000|Baseline|SHAPE Measurement|"48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.~SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min."
11241674|NCT02489045|FG000|Participant Flow|SHAPE Measurement|"48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.~SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min."
11241675|NCT02489045|OG000|Outcome|SHAPE Measurement|"48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.~SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min."
11241676|NCT02489045|EG000|Reported Event|SHAPE Measurement|"48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.~SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min."
11241677|NCT02489110|BG000|Baseline|Webnovela|"Caregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access.~Webnovela"
11241678|NCT02489110|BG001|Baseline|Control|"Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language.~Information"
11241679|NCT02489110|BG002|Baseline|Total|Total of all reporting groups
11241680|NCT02489110|FG000|Participant Flow|Webnovela|"Caregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access.~Webnovela"
11241681|NCT02489110|FG001|Participant Flow|Control|"Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language.~Information"
11391527|NCT02898259|EG001|Reported Event|DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391528|NCT02898259|EG002|Reported Event|DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2)|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391529|NCT02898259|EG003|Reported Event|Expansion Cohort I: Follicular Lymphoma at MTD|Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration
11391530|NCT02898259|EG004|Reported Event|Expansion Cohort 2: Non-Follicular Lymphoma at MTD|Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
11391531|NCT02830594|BG000|Baseline|Treatment (Pembrolizumab, RT)|"INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.~External Beam Radiation Therapy: Undergo palliative external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11391532|NCT02830594|FG000|Participant Flow|Treatment (Pembrolizumab, RT)|"INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.~External Beam Radiation Therapy: Undergo palliative external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11391533|NCT02830594|OG000|Outcome|Treatment (Pembrolizumab, RT)|"INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.~External Beam Radiation Therapy: Undergo palliative external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11391534|NCT02830594|EG000|Reported Event|Treatment (Pembrolizumab, RT)|"INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.~SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.~External Beam Radiation Therapy: Undergo palliative external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11391535|NCT02819635|BG000|Baseline|SS1: Placebo|During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391536|NCT02819635|BG001|Baseline|SS1: Upadacitinib 7.5 mg|During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391537|NCT02819635|BG002|Baseline|SS1: Upadacitinib 15 mg|During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11241682|NCT02489110|OG000|Outcome|Webnovela|"Caregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access.~Webnovela"
11241683|NCT02489110|OG001|Outcome|Control|"Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language.~Information"
11241684|NCT02489110|EG000|Reported Event|Webnovela|"Caregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access.~Webnovela"
11241685|NCT02489110|EG001|Reported Event|Control|"Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language.~Information"
11241686|NCT02489123|BG000|Baseline|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11241687|NCT02489123|FG000|Participant Flow|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11241688|NCT02489123|OG000|Outcome|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11241689|NCT02489123|EG000|Reported Event|Treatment (Enzalutamide)|"Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11241690|NCT02489227|BG000|Baseline|CHS-1420|"CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.~CHS-1420"
11241691|NCT02489227|BG001|Baseline|Humira (Adalimumab) Reassigned to CHS-1420|"Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.~Adalimumab~CHS-1420"
11241692|NCT02489227|BG002|Baseline|Humira (Adalimumab)|"Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.~Adalimumab~CHS-1420"
11241693|NCT02489227|BG003|Baseline|Total|Total of all reporting groups
11241694|NCT02489227|FG000|Participant Flow|CHS-1420|"CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.~CHS-1420"
11241695|NCT02489227|FG001|Participant Flow|Humira (Adalimumab) Reassigned to CHS-1420|"Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.open label until study end.~Adalimumab~CHS-1420"
11241696|NCT02489227|FG002|Participant Flow|Humira (Adalimumab)|"Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end..~Adalimumab~CHS-1420"
11241697|NCT02489227|OG000|Outcome|Humira (Adalimumab)|"Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420 open label until study end.~CHS-1420~Adalimumab"
11241698|NCT02489227|OG001|Outcome|CHS-1420|"CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.~CHS-1420"
11241699|NCT02489227|EG000|Reported Event|Treatment Period 1: CHS-1420|CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15
11241700|NCT02489227|EG001|Reported Event|Treatment Period 1: Humira (Adalimumab)|Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15.
11241701|NCT02489227|EG002|Reported Event|Treatment Period 2: CHS-1420/CHS-1420|At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
11241702|NCT02489227|EG003|Reported Event|Treatment Period 2: Humira/CHS-1420|At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
11241703|NCT02489227|EG004|Reported Event|Teatment Period 2: Humira/Humira|At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
11241704|NCT02489227|EG005|Reported Event|Treatment Period 3: Open Label CHS-1420 Extension|At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end
11241705|NCT02489279|BG000|Baseline|Active|"Behavioral training with the Attentional Intelligence Method mobile software to increase sustained attention skills and self-awareness of attention control.~Attentional Intelligence Method: Participants use the mobile software, Attentional Intelligence Method, on their mobile device to develop sustained attention control and executive control skills that provides self-awareness of attention control. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241706|NCT02489279|BG001|Baseline|Control|"Behavioral training with the mobile software game Scrabble to increase concentration.~Scrabble: Participants play Scrabble on their mobile device to develop concentration and executive control skills. They use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241707|NCT02489279|BG002|Baseline|Total|Total of all reporting groups
11241708|NCT02489279|FG000|Participant Flow|Active|"Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control.~Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241709|NCT02489279|FG001|Participant Flow|Control|"Behavioral learning using the mobile software game Scrabble to exercise word processing and executive control functions.~Participants in both groups are told that the study is assessing the impact on cognitive tests from exercising with games that include cognitive processing. Scrabble serves as an active control with similar face value, equivalent usage and experimenter contact.~Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241710|NCT02489279|OG000|Outcome|Active - SAC|"Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control.~Sustained Attention Control (SAC) Method: Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241711|NCT02489279|OG001|Outcome|Control - Scrabble|"Behavioral learning using the mobile software game Scrabble to exercise word processing and executive control functions.~Scrabble: Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241712|NCT02489279|EG000|Reported Event|Active|"Behavioral training with the Attentional Intelligence Method mobile software to increase sustained attention skills and self-awareness of attention control.~Attentional Intelligence Method: Participants use the mobile software, Attentional Intelligence Method, on their mobile device to develop sustained attention control and executive control skills that provides self-awareness of attention control. Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241713|NCT02489279|EG001|Reported Event|Control|"Behavioral training with the mobile software game Scrabble to increase concentration.~Scrabble: Participants play Scrabble on their mobile device to develop concentration and executive control skills. They use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks."
11241714|NCT02489344|BG000|Baseline|GZ/SAR402671|Participants received GZ/SAR402671 15 mg once daily orally for 36 months during combined ACT13739/LTS14116 treatment period.
11241715|NCT02489344|FG000|Participant Flow|GZ/SAR402671|Participants received GZ/SAR402671 15 mg once daily orally for 36 months during combined ACT13739/LTS14116 treatment period.
11241716|NCT02489344|OG000|Outcome|GZ/SAR402671|Participants received GZ/SAR402671 15 mg once daily orally for 36 months during combined ACT13739/LTS14116 treatment period.
11241717|NCT02489344|EG000|Reported Event|GZ/SAR402671|Participants received GZ/SAR402671 15 mg once daily orally for 36 months during combined ACT13739/LTS14116 treatment period.
11241718|NCT02489357|BG000|Baseline|Treatment (Pembrolizumab, Cryosurgery)|"Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving pembrolizumab, patients undergo whole gland cryoablation of the prostate.~Cryosurgery: Undergo whole gland cryoablation~Degarelix: Given SC~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11241719|NCT02489357|FG000|Participant Flow|Treatment (Pembrolizumab, Cryosurgery)|"Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving pembrolizumab, patients undergo whole gland cryoablation of the prostate.~Cryosurgery: Undergo whole gland cryoablation~Degarelix: Given SC~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11241720|NCT02489357|OG000|Outcome|Treatment (Pembrolizumab, Cryosurgery)|"Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving pembrolizumab, patients undergo whole gland cryoablation of the prostate.~Cryosurgery: Undergo whole gland cryoablation~Degarelix: Given SC~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11241721|NCT02489357|EG000|Reported Event|Treatment (Pembrolizumab, Cryosurgery)|"Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving pembrolizumab, patients undergo whole gland cryoablation of the prostate.~Cryosurgery: Undergo whole gland cryoablation~Degarelix: Given SC~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11241722|NCT02489500|BG000|Baseline|Melphalan|"Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241723|NCT02489500|BG001|Baseline|Melphalan + Bortezomib|"Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion~Bortezomib: Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241724|NCT02489500|BG002|Baseline|Total|Total of all reporting groups
11241725|NCT02489500|FG000|Participant Flow|Melphalan|"Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241726|NCT02489500|FG001|Participant Flow|Melphalan + Bortezomib|"Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion~Bortezomib: Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241727|NCT02489500|OG000|Outcome|Melphalan|"Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241728|NCT02489500|OG001|Outcome|Melphalan + Bortezomib|"Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion~Bortezomib: Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241729|NCT02489500|EG000|Reported Event|Melphalan|"Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241730|NCT02489500|EG001|Reported Event|Melphalan + Bortezomib|"Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion~Bortezomib: Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells"
11241731|NCT02489630|BG000|Baseline|Ketamine|"0.1 mg/kg ketamine + opiate analgesic~Ketamine: 0.1mg/kg ketamine IV~opiate analgesic: 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request"
11241732|NCT02489630|BG001|Baseline|Placebo|"0.1 mL/kg normal saline + opiate analgesic~Normal Saline: 1ml/kg normal saline placebo~opiate analgesic: 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request"
11241733|NCT02489630|BG002|Baseline|Total|Total of all reporting groups
11241734|NCT02489630|FG000|Participant Flow|Ketamine|"0.1 mg/kg ketamine + opiate analgesic~Ketamine: 0.1mg/kg ketamine IV~opiate analgesic: 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request"
11241735|NCT02489630|FG001|Participant Flow|Placebo|"0.1 mL/kg normal saline + opiate analgesic~Normal Saline: 1ml/kg normal saline placebo~opiate analgesic: 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request"
11241736|NCT02489630|OG000|Outcome|Ketamine|Patients receiving study intervention
11241737|NCT02489630|OG001|Outcome|Placebo|Patients not receiving study intervention
11241738|NCT02489630|EG000|Reported Event|Ketamine|Patients receiving study intervention
11241739|NCT02489630|EG001|Reported Event|Placebo|Patients not receiving study intervention
11241740|NCT02489734|BG000|Baseline|Low Concentration (LC)|In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
11241741|NCT02489734|BG001|Baseline|High Concentration (HC)|In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
11241742|NCT02489734|BG002|Baseline|Total|Total of all reporting groups
11241743|NCT02489734|FG000|Participant Flow|Low Concentration (LC)|"low concentration group~sevoflurane: extubation when end-tidal concentration of sevoflurane < 0.5%."
11241744|NCT02489734|FG001|Participant Flow|High Concentration (HC)|"high concentration group~Sevoflurane: extubation when end-tidal concentration of sevoflurane >= 0.5%."
11338432|NCT03610399|OG000|Outcome|Primaquine Regular Dose Unsupervised|"This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy.~Primaquine: Different total dose and supervision."
11338433|NCT03610399|OG001|Outcome|Primaquine Regular Dose Supervised|"This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy.~Primaquine: Different total dose and supervision."
11338434|NCT03610399|OG002|Outcome|Primaquine Double Dose Unsupervised|"This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy.~Primaquine: Different total dose and supervision."
11241745|NCT02489734|OG000|Outcome|Low Concentration (LC)|In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
11241746|NCT02489734|OG001|Outcome|High Concentration (HC)|In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
11241747|NCT02489734|EG000|Reported Event|Low Concentration (LC)|In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
11241748|NCT02489734|EG001|Reported Event|High Concentration (HC)|In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
11241749|NCT02489773|BG000|Baseline|Group 1|Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
11241750|NCT02489773|BG001|Baseline|Group 2|Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
11241751|NCT02489773|BG002|Baseline|Total|Total of all reporting groups
11241752|NCT02489773|FG000|Participant Flow|HbA1c Values Ranged From ≥7.5% to 12% (or Higher)|Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
11241753|NCT02489773|FG001|Participant Flow|HbA1c Values <7.5%|Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
11241754|NCT02489773|OG000|Outcome|HbA1c Values Ranged From ≥7.5% to 12% (or Higher)|Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
11241755|NCT02489773|OG001|Outcome|HbA1c Values <7.5%|Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
11241756|NCT02489773|EG000|Reported Event|Group 1|Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
11241757|NCT02489773|EG001|Reported Event|Group 2|Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
11241758|NCT02489799|BG000|Baseline|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11241759|NCT02489799|BG001|Baseline|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11241760|NCT02489799|BG002|Baseline|Total|Total of all reporting groups
11241761|NCT02489799|FG000|Participant Flow|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11241762|NCT02489799|FG001|Participant Flow|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11241763|NCT02489799|OG000|Outcome|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11391538|NCT02819635|BG003|Baseline|SS1: Upadacitinib 30 mg|During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11241764|NCT02489799|OG001|Outcome|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11241765|NCT02489799|EG000|Reported Event|Intervention|"Advance care planning video~Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11241766|NCT02489799|EG001|Reported Event|Control|"Control video - no advance care planning content~Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11241767|NCT02489968|BG000|Baseline|Empagliflozin 10 mg OL|Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11241768|NCT02489968|BG001|Baseline|Empagliflozin 25 mg OL|Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11241769|NCT02489968|BG002|Baseline|Total|Total of all reporting groups
11241770|NCT02489968|FG000|Participant Flow|Empagliflozin 10 mg OL|Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11241771|NCT02489968|FG001|Participant Flow|Empagliflozin 25 mg OL|Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11241772|NCT02489968|FG002|Participant Flow|Empagliflozin 10 mg + Linagliptin 5 mg|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241773|NCT02489968|FG003|Participant Flow|Empagliflozin 10 mg + Placebo|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241774|NCT02489968|FG004|Participant Flow|Empagliflozin 25 mg + Linagliptin 5 mg|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241775|NCT02489968|FG005|Participant Flow|Empagliflozin 25 mg + Placebo|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241776|NCT02489968|OG000|Outcome|Empagliflozin 10 mg + Linagliptin 5 mg|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241777|NCT02489968|OG001|Outcome|Empagliflozin 10 mg + Placebo|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241778|NCT02489968|OG002|Outcome|Empagliflozin 25 mg + Linagliptin 5 mg|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241779|NCT02489968|OG003|Outcome|Empagliflozin 25 mg + Placebo|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241780|NCT02489968|EG000|Reported Event|Empagliflozin 25 mg + Linagliptin 5 mg|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241781|NCT02489968|EG001|Reported Event|Empagliflozin 10 mg + Linagliptin 5 mg|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241782|NCT02489968|EG002|Reported Event|Empagliflozin 25 mg + Placebo|Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
11241783|NCT02489968|EG003|Reported Event|Empagliflozin 10 mg + Placebo|Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
11241784|NCT02489968|EG004|Reported Event|Empagliflozin 25 mg OL|Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11391539|NCT02819635|BG004|Baseline|SS1: Upadacitinib 45 mg|During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11241785|NCT02489968|EG005|Reported Event|Empagliflozin 10 mg OL|Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.
11241786|NCT02489981|BG000|Baseline|Spiriva® Respimat®|Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
11241787|NCT02489981|FG000|Participant Flow|Spiriva® Respimat®|Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
11241788|NCT02489981|OG000|Outcome|Spiriva® Respimat®|Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
11241789|NCT02489981|EG000|Reported Event|Spiriva® Respimat®|Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
11241790|NCT02490293|BG000|Baseline|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11241791|NCT02490293|BG001|Baseline|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11241792|NCT02490293|BG002|Baseline|Total|Total of all reporting groups
11241793|NCT02490293|FG000|Participant Flow|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11241794|NCT02490293|FG001|Participant Flow|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11241795|NCT02490293|OG000|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11391540|NCT02819635|BG005|Baseline|SS2: Placebo/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391541|NCT02819635|BG006|Baseline|SS2: Upadacitinib 45 mg/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391542|NCT02819635|BG007|Baseline|SS3: M14-675 Clinical Responders|Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
11391543|NCT02819635|BG008|Baseline|Total|Total of all reporting groups
11391544|NCT02819635|FG000|Participant Flow|SS1: Placebo|During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391545|NCT02819635|FG001|Participant Flow|SS1: Upadacitinib 7.5 mg|During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391546|NCT02819635|FG002|Participant Flow|SS1: Upadacitinib 15 mg|During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391547|NCT02819635|FG003|Participant Flow|SS1: Upadacitinib 30 mg|During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391548|NCT02819635|FG004|Participant Flow|SS1: Upadacitinib 45 mg|During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391549|NCT02819635|FG005|Participant Flow|SS2: Placebo/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391550|NCT02819635|FG006|Participant Flow|SS2: Upadacitinib 45 mg/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391551|NCT02819635|FG007|Participant Flow|SS3: M14-675 Clinical Responders|Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
11391552|NCT02819635|FG008|Participant Flow|SS3: Placebo|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
11391553|NCT02819635|FG009|Participant Flow|SS3: UPA 7.5 mg|Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
11391554|NCT02819635|FG010|Participant Flow|SS3: UPA 15 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
11391555|NCT02819635|FG011|Participant Flow|SS3: UPA 30 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
11391556|NCT02819635|OG000|Outcome|SS1: Placebo|During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391557|NCT02819635|OG001|Outcome|SS1: Upadacitinib 7.5 mg|During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391558|NCT02819635|OG002|Outcome|SS1: Upadacitinib 15 mg|During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391559|NCT02819635|OG003|Outcome|SS1: Upadacitinib 30 mg|During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391560|NCT02819635|OG004|Outcome|SS1: Upadacitinib 45 mg|During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391561|NCT02819635|OG000|Outcome|SS2: Placebo|During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391562|NCT02819635|OG001|Outcome|SS2: Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391563|NCT02819635|OG000|Outcome|SS3: Placebo|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
11391564|NCT02819635|OG001|Outcome|SS3: UPA 15 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
11391565|NCT02819635|OG002|Outcome|SS3: UPA 30 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
11391566|NCT02819635|OG000|Outcome|SS3: Placebo|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
11338435|NCT03610399|EG000|Reported Event|Primaquine Regular Dose Unsupervised|"This is the regular primaquine dose (3.5 mg/kg) Brazil without directly observed therapy.~Primaquine: Different total dose and supervision."
11338436|NCT03610399|EG001|Reported Event|Primaquine Regular Dose Supervised|"This is the regular primaquine dose (3.5 mg/kg) in Brazil but with directly observed therapy.~Primaquine: Different total dose and supervision."
11338437|NCT03610399|EG002|Reported Event|Primaquine Double Dose Unsupervised|"This is the double total primaquine dose (14 days) (7.0 mg/kg) in Brazil with directly observed therapy.~Primaquine: Different total dose and supervision."
11338438|NCT03610464|BG000|Baseline|Study Patients (AMPH EROS)|"All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base~Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis"
11338439|NCT03610464|FG000|Participant Flow|Study Patients (AMPH EROS)|"All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base~Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis"
11338440|NCT03610464|OG000|Outcome|Plasma Concentration of d-Amphetamine|"All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base~Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis"
11338441|NCT03610464|OG001|Outcome|Plasma Concentration of l-Amphetamine|"All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base~Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis"
11338442|NCT03610464|EG000|Reported Event|Study Patients (AMPH EROS)|"All patients treated with extended-release oral suspension (AMPH EROS) that contains 2.5 mg/mL amphetamine base~Amphetamine Extended Release Suspension [Dyanavel]: 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis"
11338443|NCT03610581|BG000|Baseline|Regimen 1|Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57.
11338444|NCT03610581|BG001|Baseline|Placebo|Participants received matching placebo on Day 1 and Day 57.
11338445|NCT03610581|BG002|Baseline|Total|Total of all reporting groups
11338446|NCT03610581|FG000|Participant Flow|Regimen 1|Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57.
11338447|NCT03610581|FG001|Participant Flow|Placebo|Participants received matching placebo on Day 1 and Day 57.
11338448|NCT03610581|OG000|Outcome|Regimen 1|Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57.
11338449|NCT03610581|OG001|Outcome|Placebo|Participants received matching placebo on Day 1 and Day 57.
11338450|NCT03610581|EG000|Reported Event|Regimen 1|Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57.
11338451|NCT03610581|EG001|Reported Event|Placebo|Participants received matching placebo on Day 1 and Day 57.
11338452|NCT03610633|BG000|Baseline|Oxytocin/Alcohol Use Disorder|"Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures.~Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress."
11338453|NCT03610633|BG001|Baseline|Placebo/Alcohol Use Disorder|"Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.~Placebo: Saline solution."
11338454|NCT03610633|BG002|Baseline|Total|Total of all reporting groups
11338455|NCT03610633|FG000|Participant Flow|Oxytocin/Alcohol Use Disorder|"Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures.~Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress."
11338456|NCT03610633|FG001|Participant Flow|Placebo/Alcohol Use Disorder|"Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.~Placebo: Saline solution."
11338457|NCT03610633|OG000|Outcome|Oxytocin/Alcohol Use Disorder|"Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures.~Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress."
11338458|NCT03610633|OG001|Outcome|Placebo/Alcohol Use Disorder|"Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.~Placebo: Saline solution."
11338459|NCT03610633|EG000|Reported Event|Oxytocin/Alcohol Use Disorder|"Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures.~Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress."
11338460|NCT03610633|EG001|Reported Event|Placebo/Alcohol Use Disorder|"Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.~Placebo: Saline solution."
11338461|NCT03611062|BG000|Baseline|VR Executive Functions Training|"Participants will receive training of executive functions in a virtual reality environment.~VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named Lubdub from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs."
11338462|NCT03611062|BG001|Baseline|Control|"Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions.~VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience."
11338463|NCT03611062|BG002|Baseline|Total|Total of all reporting groups
11391567|NCT02819635|OG002|Outcome|SS3: UPA 30 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks.
11391568|NCT02819635|OG001|Outcome|SS3: UPA 15 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks.
11391569|NCT02819635|EG000|Reported Event|SS1: Placebo|During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391570|NCT02819635|EG001|Reported Event|SS1: Upadacitinib 7.5 mg|During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391571|NCT02819635|EG002|Reported Event|SS1: Upadacitinib 15 mg|During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11197879|NCT02174731|FG000|Participant Flow|Roxadustat|Participants received roxadustat tablets orally three times a week (TIW) throughout the treatment period (up to 4 years). For hemodialysis (HD) participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain hemoglobin (Hb) values of 11±1 grams per deciliter (g/dL). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.
11197880|NCT02174731|FG001|Participant Flow|Epoetin Alfa|Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) subcutaneous (SC) or intravenous (IV) injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 international unit per kilogram (IU/kg) TIW. Dose adjustments were to be consistent with local approved prescribing information.
11197881|NCT02174731|OG000|Outcome|Roxadustat|Participants received roxadustat tablets orally TIW throughout the treatment period (up to 4 years). For HD participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain Hb values of 11±1 g/dL. Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.
11197882|NCT02174731|OG001|Outcome|Epoetin Alfa|Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) SC or IV injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 IU/kg TIW. Dose adjustments were to be consistent with local approved prescribing information.
11197883|NCT02174731|EG000|Reported Event|Roxadustat|Participants received roxadustat tablets orally TIW throughout the treatment period (up to 4 years). For HD participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain Hb values of 11±1 g/dL. Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.
11197884|NCT02174731|EG001|Reported Event|Epoetin Alfa|Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) SC or IV injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 IU/kg TIW. Dose adjustments were to be consistent with local approved prescribing information.
11391572|NCT02819635|EG003|Reported Event|SS1: Upadacitinib 30 mg|During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391573|NCT02819635|EG004|Reported Event|SS1: Upadacitinib 45 mg|During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
11391574|NCT02819635|EG005|Reported Event|SS2: Placebo|During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391575|NCT02819635|EG006|Reported Event|SS2: Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
11391576|NCT02819635|EG007|Reported Event|SS2: Placebo/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391577|NCT02819635|EG008|Reported Event|SS2: Upadacitinib 45 mg/Upadacitinib 45 mg|During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
11391578|NCT02819635|EG009|Reported Event|SS3: Placebo|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
11391579|NCT02819635|EG010|Reported Event|SS3: Upadacitinib 7.5 mg|Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
11391580|NCT02819635|EG011|Reported Event|SS3: Upadacitinib 15 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
11391581|NCT02819635|EG012|Reported Event|SS3: Upadacitinib 30 mg|Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
11391582|NCT02756013|BG000|Baseline|Paclitaxel + Carboplatin|"Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.~Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles~Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles"
11391583|NCT02756013|FG000|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel dosed by actual body surface area (BSA) and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.~Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles~Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles"
11391584|NCT02756013|OG000|Outcome|Paclitaxel + Carboplatin|"Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.~Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles~Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles"
11391585|NCT02756013|EG000|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.~Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles~Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles"
11391586|NCT02681614|BG000|Baseline|Uronav|"Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation~o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.~Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.~Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study."
11391587|NCT02681614|FG000|Participant Flow|Uronav|"Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation~o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.~Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.~Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study."
11391588|NCT02681614|OG000|Outcome|Uronav|"Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation~o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.~Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.~Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study."
11391589|NCT02681614|OG000|Outcome|Uronav|"Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation.~All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.~Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia.~Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.~Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study."
11391590|NCT02681614|EG000|Reported Event|Uronav|"Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation~o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.~Uronav guided biopsy: All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.~Magnetic resonance imaging: An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study."
11391591|NCT02667067|BG000|Baseline|Anterior Cervical Discectomy & Fusion (ACDF)|"Anterior Cervical Discectomy & Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial."
11391592|NCT02667067|BG001|Baseline|Simplify Disc|"Simplify Disc~Simplify Disc: Simplify Disc at one level in the cervical spine."
11391593|NCT02667067|BG002|Baseline|Total|Total of all reporting groups
11391594|NCT02667067|FG000|Participant Flow|Anterior Cervical Discectomy & Fusion (ACDF)|"Anterior Cervical Discectomy & Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial."
11391595|NCT02667067|FG001|Participant Flow|Simplify Disc|"Simplify Disc~Simplify Disc: Simplify Disc at one level in the cervical spine."
11391596|NCT02667067|OG000|Outcome|Anterior Cervical Discectomy & Fusion (ACDF)|"Anterior Cervical Discectomy & Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial."
11391597|NCT02667067|OG001|Outcome|Simplify Disc|"Simplify Disc~Simplify Disc: Simplify Disc at one level in the cervical spine."
11391598|NCT02667067|OG000|Outcome|Simplify Disc|"Simplify Disc~Simplify Disc: Simplify Disc at one level in the cervical spine."
11391599|NCT02667067|EG000|Reported Event|Anterior Cervical Discectomy & Fusion (ACDF)|"Anterior Cervical Discectomy & Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial."
11391600|NCT02667067|EG001|Reported Event|Simplify Disc|"Simplify Disc~Simplify Disc: Simplify Disc at one level in the cervical spine."
11391601|NCT02601209|BG000|Baseline|Phase I - Dose Level 0|Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391602|NCT02601209|BG001|Baseline|Phase I - Dose Level 1|Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391603|NCT02601209|BG002|Baseline|Phase I - Dose Level 2|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391604|NCT02601209|BG003|Baseline|Phase II - Analysis Group 1 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391605|NCT02601209|BG004|Baseline|Phase II - Analysis Group 1 Pazopanib|Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
11391606|NCT02601209|BG005|Baseline|Phase II - Analysis Group 2 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391607|NCT02601209|BG006|Baseline|Phase II - Analysis Group 2 Pazopanib|Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
11391608|NCT02601209|BG007|Baseline|Total|Total of all reporting groups
11391609|NCT02601209|FG000|Participant Flow|Phase I - Dose Level 0|Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391610|NCT02601209|FG001|Participant Flow|Phase I - Dose Level 1|Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391611|NCT02601209|FG002|Participant Flow|Phase I - Dose Level 2|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
10800141|NCT02527434|EG005|Reported Event|PDAC - COMBO|Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
10800142|NCT02527434|EG006|Reported Event|UBC- MEDI|Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
10965917|NCT00884611|OG003|Outcome|Algorithm 2 - Intervention Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
10965918|NCT00884611|OG004|Outcome|Algorithm 3 - Control Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
10965919|NCT00884611|OG005|Outcome|Algorithm 3 - Intervention Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
10965920|NCT00884611|EG000|Reported Event|Control Night (PLGS Algorithm OFF)|"Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.~Data for control night are reported in this group."
10800143|NCT02527434|EG007|Reported Event|PDAC - MEDI|Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
10800144|NCT02513667|BG000|Baseline|ALK-inhibitor Naive Patients|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
11197885|NCT02174848|BG000|Baseline|Placebo-DFP|Patients who received 18 months of placebo treatment in the TIRCON2012V1 study and were then switched to deferiprone in the extension study, so received up to 18 months of deferiprone treatment.
11197886|NCT02174848|BG001|Baseline|DFP-DFP|Patients who received 18 months of deferiprone treatment in the TIRCON2012V1 study and continued to receive it in the extension study, so received up to 36 months of deferiprone treatment.
11197887|NCT02174848|BG002|Baseline|Total|Total of all reporting groups
11197888|NCT02174848|FG000|Participant Flow|Placebo-DFP|Patients in this group had been randomized to placebo treatment in the TIRCON2012V1 study and were then switched to deferiprone in the extension study. Accordingly, they received up to 18 months of deferiprone treatment over the duration of the two studies.
11197889|NCT02174848|FG001|Participant Flow|DFP-DFP|Patients in this group had been randomized to deferiprone treatment in the TIRCON2012V1 study and then continued on deferiprone in the extension study. Accordingly, they received up to 36 months of deferiprone treatment over the duration of the two studies.
11197890|NCT02174848|OG000|Outcome|Placebo-DFP|Patients in this group had been randomized to placebo treatment in the TIRCON2012V1 study and were then switched to deferiprone in the extension study. Accordingly, they received up to 18 months of deferiprone treatment.
11197891|NCT02174848|OG001|Outcome|DFP-DFP|Patients in this group had been randomized to deferiprone treatment in the TIRCON2012V1 study and then continued on deferiprone in the extension study. Accordingly, they received up to 36 months of deferiprone treatment.
11197892|NCT02174848|OG000|Outcome|Placebo-DFP|Patients in this group had been randomized to placebo treatment in the TIRCON2012V1 study and were then switched to deferiprone in the extension study. Accordingly, they received up to 18 months of deferiprone treatment over the duration of the two studies.
11391612|NCT02601209|FG003|Participant Flow|Phase II - Analysis Group 1 Pazopanib|Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
11391613|NCT02601209|FG004|Participant Flow|Phase II - Analysis Group 1 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391614|NCT02601209|FG005|Participant Flow|Phase II - Analysis Group 2 Pazopanib|Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
11391615|NCT02601209|FG006|Participant Flow|Phase II - Analysis Group 2 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391616|NCT02601209|FG007|Participant Flow|Phase II - Analysis Group 1 Pazopanib Crossover|Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
11391617|NCT02601209|FG008|Participant Flow|Phase II - Analysis Group 2 Pazopanib Crossover|Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
11391618|NCT02601209|OG000|Outcome|Phase I - Dose Level 0|Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391619|NCT02601209|OG001|Outcome|Phase I - Dose Level 1|Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391620|NCT02601209|OG002|Outcome|Phase I - Dose Level 2|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391621|NCT02601209|OG000|Outcome|Phase II - Analysis Group 2 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391622|NCT02601209|OG001|Outcome|Phase II - Analysis Group 2 Pazopanib|Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
11391623|NCT02601209|EG000|Reported Event|Phase I - Dose Level 0|Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391624|NCT02601209|EG001|Reported Event|Phase I - Dose Level 1|Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391625|NCT02601209|EG002|Reported Event|Phase I - Dose Level 2|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
11391626|NCT02601209|EG003|Reported Event|Phase II - Analysis Group 1 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391627|NCT02601209|EG004|Reported Event|Phase II - Analysis Group 1 Pazopanib|Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
11391628|NCT02601209|EG005|Reported Event|Phase II - Analysis Group 2 MLN0128|Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
11391629|NCT02601209|EG006|Reported Event|Phase II - Analysis Group 2 Pazopanib|Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
11391630|NCT02551718|BG000|Baseline|Chemosensitivity Testing|"Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.~Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations~Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection~Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets~Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets~In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs:~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
11391631|NCT02551718|FG000|Participant Flow|Chemosensitivity Testing|"Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.~Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations~Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection~Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets~Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets~In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs:~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
11197893|NCT02174848|OG001|Outcome|DFP-DFP|Patients in this group had been randomized to deferiprone treatment in the TIRCON2012V1 study and then continued on deferiprone in the extension study. Accordingly, they received up to 36 months of deferiprone treatment over the duration of the two studies.
11197894|NCT02174848|OG000|Outcome|Placebo-DFP in Initial Study|During the initial study, patients in the placebo-DFP group received 18 months of treatment with placebo
11197895|NCT02174848|OG001|Outcome|Placebo-DFP in Extension Study|During the extension study, patients in the placebo-DFP group received up to 18 months of treatment with deferiprone
11197896|NCT02174848|OG000|Outcome|DFP-DFP Group in Initial Study|During the initial study, patients in the DFP-DFP group received 18 months of treatment with deferiprone
11197897|NCT02174848|OG001|Outcome|DFP-DFP Group in Extension Study|During the extension study, patients in the DFP-DFP group received up to an additional 18 months of treatment with deferiprone
11197898|NCT02174848|EG000|Reported Event|All Patients|All participants received deferiprone during the extension study
11197899|NCT02174913|BG000|Baseline|Bispectral Index|Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
11197900|NCT02174913|BG001|Baseline|Clinical Signs|Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
11197901|NCT02174913|BG002|Baseline|Total|Total of all reporting groups
11197902|NCT02174913|FG000|Participant Flow|Bispectral Index|Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
11197903|NCT02174913|FG001|Participant Flow|Clinical Signs|Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
11197904|NCT02174913|OG000|Outcome|Bispectral Index|Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
11197905|NCT02174913|OG001|Outcome|Clinical Signs|Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
11197906|NCT02174913|EG000|Reported Event|Bispectral Index|Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
11197907|NCT02174913|EG001|Reported Event|Clinical Signs|Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
11197908|NCT02175121|BG000|Baseline|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
11197909|NCT02175121|BG001|Baseline|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197910|NCT02175121|BG002|Baseline|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
11197911|NCT02175121|BG003|Baseline|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197912|NCT02175121|BG004|Baseline|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
11197913|NCT02175121|BG005|Baseline|Total|Total of all reporting groups
11197914|NCT02175121|FG000|Participant Flow|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
11197915|NCT02175121|FG001|Participant Flow|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197916|NCT02175121|FG002|Participant Flow|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
11197917|NCT02175121|FG003|Participant Flow|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197918|NCT02175121|FG004|Participant Flow|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
11197919|NCT02175121|OG000|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
11197920|NCT02175121|OG001|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197921|NCT02175121|OG002|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
11197922|NCT02175121|OG003|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197923|NCT02175121|OG004|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
11197924|NCT02175121|OG000|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197925|NCT02175121|OG001|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
11197926|NCT02175121|OG002|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197927|NCT02175121|OG003|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
11197928|NCT02175121|EG000|Reported Event|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
11197929|NCT02175121|EG001|Reported Event|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197930|NCT02175121|EG002|Reported Event|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
11197931|NCT02175121|EG003|Reported Event|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
11197932|NCT02175121|EG004|Reported Event|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
11391632|NCT02551718|OG000|Outcome|Chemosensitivity Testing and Treatment Initiation Within 21 Days|"Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.~Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations~Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection~Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets~Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets~In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs:~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
11391633|NCT02551718|OG000|Outcome|Treatment (Chemosensitivity Testing, Chemotherapy)|"Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.~Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations~Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection~Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets~Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets~In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs:~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
11391634|NCT02551718|EG000|Reported Event|Chemosensitivity Testing|"Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.~Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations~Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection~Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets~Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets~In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs:~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
11391635|NCT02419807|BG000|Baseline|Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)|Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
11391636|NCT02419807|FG000|Participant Flow|Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)|Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
11391637|NCT02419807|OG000|Outcome|Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)|Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
11391638|NCT02419807|EG000|Reported Event|Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)|Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
11197933|NCT02175199|BG000|Baseline|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
10965921|NCT00884611|EG001|Reported Event|Intervention Night (PLGS Algorithm ON)|"Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.~Data for intervention nights are reported in this group."
10965922|NCT00884650|BG000|Baseline|Group 1|Group 1 will receive oral analgesia only
10965923|NCT00884650|BG001|Baseline|Group 2|Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
10965924|NCT00884650|BG002|Baseline|Total|Total of all reporting groups
11197934|NCT02175199|BG001|Baseline|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
11197935|NCT02175199|BG002|Baseline|Total|Total of all reporting groups
11197936|NCT02175199|FG000|Participant Flow|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
11391639|NCT02278120|BG000|Baseline|LEE011 + NSAI/Tamoxifen + Goserelin|LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391640|NCT02278120|BG001|Baseline|LEE011 Placebo + NSAI/Tamoxifen+ Goserelin|LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391641|NCT02278120|BG002|Baseline|Total|Total of all reporting groups
11391642|NCT02278120|FG000|Participant Flow|LEE011 + NSAI/Tamoxifen + Goserelin|LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391643|NCT02278120|FG001|Participant Flow|LEE011 Placebo + NSAI/Tamoxifen+ Goserelin|LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391644|NCT02278120|OG000|Outcome|LEE011 + NSAI/Tamoxifen + Goserelin|LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391645|NCT02278120|OG001|Outcome|LEE011 Placebo + NSAI/Tamoxifen+ Goserelin|LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391646|NCT02278120|EG000|Reported Event|LEE011 + NSAI/Tamoxifen + Goserelin|LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391647|NCT02278120|EG001|Reported Event|LEE011 Placebo + NSAI/Tamoxifen + Goserelin|LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
11391648|NCT02242942|BG000|Baseline|Obinutuzumab + Chlorambucil|Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
11391649|NCT02242942|BG001|Baseline|Obinutuzumab + Venetoclax|Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
11391650|NCT02242942|BG002|Baseline|Safety Run-in Obinutuzumab + Venetoclax|Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
11391651|NCT02242942|BG003|Baseline|Total|Total of all reporting groups
11391652|NCT02242942|FG000|Participant Flow|Obinutuzumab + Chlorambucil|Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
11391653|NCT02242942|FG001|Participant Flow|Obinutuzumab + Venetoclax|Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
11391654|NCT02242942|FG002|Participant Flow|Safety Run-in Obinutuzumab + Venetoclax|Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
11391655|NCT02242942|OG000|Outcome|Obinutuzumab + Chlorambucil|Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
11391656|NCT02242942|OG001|Outcome|Obinutuzumab + Venetoclax|Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
11391657|NCT02242942|OG000|Outcome|Obinutuzumab + Chlorambucil|Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
11391658|NCT02242942|OG001|Outcome|Obinutuzumab + Venetoclax|Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
11391659|NCT02242942|OG000|Outcome|Obinutuzumab + Venetoclax|Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
11391660|NCT02242942|EG000|Reported Event|Obinutuzumab + Chlorambucil|Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
11391661|NCT02242942|EG001|Reported Event|Obinutuzumab + Venetoclax|Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
11391662|NCT02242942|EG002|Reported Event|Safety Run-in Obinutuzumab + Venetoclax|Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
11391663|NCT02231749|BG000|Baseline|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
11391664|NCT02231749|BG001|Baseline|Sunitinib|Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
11391665|NCT02231749|BG002|Baseline|Total|Total of all reporting groups
11391666|NCT02231749|FG000|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
11391667|NCT02231749|FG001|Participant Flow|Sunitinib|Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
10965925|NCT00884650|FG000|Participant Flow|Oral Analgesia Only|Group 1 will receive oral analgesia only
11197937|NCT02175199|FG001|Participant Flow|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
11197938|NCT02175199|OG000|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
11197939|NCT02175199|OG001|Outcome|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
11197940|NCT02175199|EG000|Reported Event|Pre-treatment|Includes all subjects prior to the exposure to the investigational or control products
11197941|NCT02175199|EG001|Reported Event|AIR OPTIX COLORS|Includes all eyes exposed to AIR OPTIX® COLORS contact lenses
11197942|NCT02175199|EG002|Reported Event|FreshLook COLORBLENDS|Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
11197943|NCT02175212|BG000|Baseline|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197944|NCT02175212|BG001|Baseline|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197945|NCT02175212|BG002|Baseline|Total|Total of all reporting groups
11197946|NCT02175212|FG000|Participant Flow|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197947|NCT02175212|FG001|Participant Flow|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197948|NCT02175212|OG000|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197949|NCT02175212|OG001|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197950|NCT02175212|EG000|Reported Event|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197951|NCT02175212|EG001|Reported Event|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)"
11197952|NCT02175225|BG000|Baseline|Deferoxamine Mesylate|"Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days~Deferoxamine Mesylate"
11197953|NCT02175225|BG001|Baseline|Normal Saline|"Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days~Placebo (for Deferoxamine Mesylate)"
11197954|NCT02175225|BG002|Baseline|Total|Total of all reporting groups
11197955|NCT02175225|FG000|Participant Flow|Deferoxamine Mesylate|"Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days~Deferoxamine Mesylate"
11197956|NCT02175225|FG001|Participant Flow|Normal Saline|"Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days~Placebo (for Deferoxamine Mesylate)"
11197957|NCT02175225|OG000|Outcome|Deferoxamine Mesylate|"Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days~Deferoxamine Mesylate"
11197958|NCT02175225|OG001|Outcome|Normal Saline|"Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days~Placebo (for Deferoxamine Mesylate)"
11197959|NCT02175225|EG000|Reported Event|Deferoxamine Mesylate|"Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days~Deferoxamine Mesylate"
11197960|NCT02175225|EG001|Reported Event|Normal Saline|"Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days~Placebo (for Deferoxamine Mesylate)"
11391668|NCT02231749|OG000|Outcome|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
11391669|NCT02231749|OG001|Outcome|Sunitinib|Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
11391670|NCT02231749|EG000|Reported Event|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
11391671|NCT02231749|EG001|Reported Event|Sunitinib|"Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks"
11391672|NCT02227199|BG000|Baseline|Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.2mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391673|NCT02227199|BG001|Baseline|Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391674|NCT02227199|BG002|Baseline|Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391675|NCT02227199|BG003|Baseline|Total|Total of all reporting groups
11391676|NCT02227199|FG000|Participant Flow|Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391677|NCT02227199|FG001|Participant Flow|Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391678|NCT02227199|FG002|Participant Flow|Phase 2: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391679|NCT02227199|OG000|Outcome|Treatment (Brentuximab, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
10965926|NCT00884650|FG001|Participant Flow|Anesthetic Continuous-Infusion + Oral Analgesia|Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
11197961|NCT02175277|BG000|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
11391680|NCT02227199|OG000|Outcome|Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391681|NCT02227199|OG001|Outcome|Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391682|NCT02227199|OG002|Outcome|Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391683|NCT02227199|OG000|Outcome|Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391684|NCT02227199|OG001|Outcome|Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391685|NCT02227199|OG002|Outcome|Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391686|NCT02227199|EG000|Reported Event|Phase 1: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391687|NCT02227199|EG001|Reported Event|Phase 1: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|"Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.~Brentuximab Vedotin: Given IV~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11391688|NCT02227199|EG002|Reported Event|Phase 2: Dose Expansion, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)|Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.
11391689|NCT02181413|BG000|Baseline|Placebo|Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
10965927|NCT00884650|OG000|Outcome|Oral Analgesia Only|Group 1 will receive oral analgesia only
11197962|NCT02175277|FG000|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
11197963|NCT02175277|OG000|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
10965928|NCT00884650|OG001|Outcome|Anesthetic Continuous-Infusion + Oral Analgesia|Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
11197964|NCT02175277|EG000|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
11197965|NCT02175368|BG000|Baseline|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
11197966|NCT02175368|FG000|Participant Flow|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
11197967|NCT02175368|OG000|Outcome|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
11197968|NCT02175368|EG000|Reported Event|Adhese One F Upgrade|"Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).~Adhese One F Upgrade"
11197969|NCT02175472|BG000|Baseline|Spectramax Light Therapy Device|"Light therapy device which emits a specific bandwidth combination and intensity of light.~Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light."
11197970|NCT02175472|BG001|Baseline|Control Light Device|"Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.~Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response."
11197971|NCT02175472|BG002|Baseline|Total|Total of all reporting groups
11197972|NCT02175472|FG000|Participant Flow|Spectramax Light Therapy Device|"Light therapy device which emits a specific bandwidth combination and intensity of light.~Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light."
11197973|NCT02175472|FG001|Participant Flow|Control Light Device|"Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.~Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response."
11197974|NCT02175472|OG000|Outcome|Spectramax Light Therapy Device|"Light therapy device which emits a specific bandwidth combination and intensity of light.~Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light."
11197975|NCT02175472|OG001|Outcome|Control Light Device|"Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.~Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response."
11197976|NCT02175472|EG000|Reported Event|Spectramax Light Therapy Device|"Light therapy device which emits a specific bandwidth combination and intensity of light.~Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light."
11197977|NCT02175472|EG001|Reported Event|Control Light Device|"Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.~Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response."
11197978|NCT02175641|BG000|Baseline|Peer-led Group Lifestyle Balance|"Group-based behavioral healthy lifestyle program~Peer-Led Group Lifestyle Balance: The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197979|NCT02175641|BG001|Baseline|Usual Care Services|"Usual wellness and health care services offered to clients at the two supportive housing agencies.~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197980|NCT02175641|BG002|Baseline|Total|Total of all reporting groups
11197981|NCT02175641|FG000|Participant Flow|Peer-led Group Lifestyle Balance|"Group-based behavioral healthy lifestyle program~Peer-Led Group Lifestyle Balance: The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197982|NCT02175641|FG001|Participant Flow|Usual Care Services|"Usual wellness and health care services offered to clients at the two supportive housing agencies.~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11338464|NCT03611062|FG000|Participant Flow|VR Executive Functions Training|"Participants will receive training of executive functions in a virtual reality environment.~VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named Lubdub from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs."
11197983|NCT02175641|OG000|Outcome|Peer-led Group Lifestyle Balance|"Group-based behavioral healthy lifestyle program~Peer-Led Group Lifestyle Balance: The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197984|NCT02175641|OG001|Outcome|Usual Care Services|"Usual wellness and health care services offered to clients at the two supportive housing agencies.~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197985|NCT02175641|EG000|Reported Event|Peer-led Group Lifestyle Balance|"Group-based behavioral healthy lifestyle program~Peer-Led Group Lifestyle Balance: The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197986|NCT02175641|EG001|Reported Event|Usual Care Services|"Usual wellness and health care services offered to clients at the two supportive housing agencies.~Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness."
11197987|NCT02175745|BG000|Baseline|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
11197988|NCT02175745|FG000|Participant Flow|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
11197989|NCT02175745|OG000|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
11197990|NCT02175745|EG000|Reported Event|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
11197991|NCT02175758|BG000|Baseline|12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11197992|NCT02175758|BG001|Baseline|12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11197993|NCT02175758|BG002|Baseline|6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11197994|NCT02175758|BG003|Baseline|6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11197995|NCT02175758|BG004|Baseline|3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11197996|NCT02175758|BG005|Baseline|3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11197997|NCT02175758|BG006|Baseline|Total|Total of all reporting groups
11197998|NCT02175758|FG000|Participant Flow|12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11197999|NCT02175758|FG001|Participant Flow|12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11340628|NCT03661697|EG000|Reported Event|Lytera Arm|"4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340629|NCT03661697|EG001|Reported Event|Placebo Arm|"4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Basic Skin Care Regimen Only and Laser Therapy: Not Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11391690|NCT02181413|BG001|Baseline|Ixazomib Citrate|Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated.
11391691|NCT02181413|BG002|Baseline|Total|Total of all reporting groups
11391692|NCT02181413|FG000|Participant Flow|Placebo|Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
11391693|NCT02181413|FG001|Participant Flow|Ixazomib Citrate|Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated.
11391694|NCT02181413|OG000|Outcome|Placebo|Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
11391695|NCT02181413|OG001|Outcome|Ixazomib Citrate|Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated.
11391696|NCT02181413|EG000|Reported Event|Placebo|Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
11391697|NCT02181413|EG001|Reported Event|Ixazomib Citrate|Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated.
11391698|NCT02095678|BG000|Baseline|Dynamic Contrast Enhanced MRI|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results~free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391699|NCT02095678|BG001|Baseline|Free-Breathing Quantification of Relaxation Parameters|"Patients with benign liver lesions will be referred to the study team. 3-5 days after a clinical MRI an experimental, free-breathing MRI will be performed on these patients. The results will be compared to their clinical MRI images and to images of HCC or metastatic lesions~free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391700|NCT02095678|BG002|Baseline|Total|Total of all reporting groups
11391701|NCT02095678|FG000|Participant Flow|Dynamic Contrast Enhanced MRI|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results~free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391702|NCT02095678|FG001|Participant Flow|Free-Breathing Quantification of Relaxation Parameters|"Patients with benign liver lesions will be referred to the study team. 3-5 days after a clinical MRI an experimental, free-breathing MRI will be performed on these patients. The results will be compared to their clinical MRI images and to images of HCC or metastatic lesions~free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391703|NCT02095678|OG000|Outcome|Dynamic Contrast Enhanced MRI - HCC Lesions|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391704|NCT02095678|OG001|Outcome|Dynamic Contrast Enhanced MRI - Metastatic Lesions|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11340630|NCT03661762|BG000|Baseline|Healthy Volunteers|"All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.~CAVA: prototype device for monitoring dizziness"
10965929|NCT00884650|OG000|Outcome|Group I & Group II|Group I: Allocated to receive oral analgesics only Group II: Anesthetic Continuous Infusion + Oral Analgesia
10965930|NCT00884650|EG000|Reported Event|Oral Analgesia Only|Group 1 will receive oral analgesia only
11340631|NCT03661762|FG000|Participant Flow|Healthy Volunteers|All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.
11340632|NCT03661762|OG000|Outcome|Healthy Volunteers|All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.
11340633|NCT03661762|OG000|Outcome|Healthy Volunteers|"All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.~CAVA: prototype device for monitoring dizziness"
11340634|NCT03661762|EG000|Reported Event|Healthy Volunteers|All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.
11340635|NCT03661814|BG000|Baseline|Prevena|Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
11340636|NCT03661814|BG001|Baseline|Standard of Care|This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
11340637|NCT03661814|BG002|Baseline|Total|Total of all reporting groups
11340638|NCT03661814|FG000|Participant Flow|Prevena|Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
11340639|NCT03661814|FG001|Participant Flow|Standard of Care|This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
11340640|NCT03661814|OG000|Outcome|Prevena|Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
11340641|NCT03661814|OG001|Outcome|Standard of Care|This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
11340642|NCT03661814|EG000|Reported Event|Prevena|Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
11340643|NCT03661814|EG001|Reported Event|Standard of Care|This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
11340644|NCT03661983|BG000|Baseline|Open Label Stabilization Phase: Aripiprazole|Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
11340645|NCT03661983|FG000|Participant Flow|Open Label Stabilization Phase: Aripiprazole|Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
11340646|NCT03661983|FG001|Participant Flow|Double Blind Phase: Aripiprazole Full Dose|Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
11340647|NCT03661983|FG002|Participant Flow|Double Blind Phase: Aripiprazole Half Dose|Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
11340648|NCT03661983|FG003|Participant Flow|Double Blind Phase: Placebo|Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
11340649|NCT03661983|OG000|Outcome|Double Blind Phase: Aripiprazole Full Dose|Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
11340650|NCT03661983|OG001|Outcome|Double Blind Phase: Aripiprazole Half Dose|Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
11340651|NCT03661983|OG002|Outcome|Double Blind Phase: Placebo|Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
11340761|NCT03663283|BG000|Baseline|Liposomal Bupivacaine|"Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Liposomal Bupivacaine: Interscalene Nerve Blocks"
11391705|NCT02095678|OG002|Outcome|Dynamic Contrast Enhanced MRI - Benign Lesions|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391706|NCT02095678|OG000|Outcome|Dynamic Contrast Enhanced MRI|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391707|NCT02095678|OG001|Outcome|Free-Breathing Quantification of Relaxation Parameters|Patients with benign liver lesions will be referred to the study team. 3-5 days after a clinical MRI an experimental, free-breathing MRI will be performed on these patients. The results will be compared to their clinical MRI images and to images of HCC or metastatic lesions free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality
11391708|NCT02095678|EG000|Reported Event|Dynamic Contrast Enhanced MRI|"Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.~liver biopsy: patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality"
11391709|NCT02095678|EG001|Reported Event|Free-Breathing Quantification of Relaxation Parameters|Patients with benign liver lesions will be referred to the study team. 3-5 days after a clinical MRI an experimental, free-breathing MRI will be performed on these patients. The results will be compared to their clinical MRI images and to images of HCC or metastatic lesions free-breathing MRI: All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality
11391710|NCT01990209|BG000|Baseline|Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors|Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
11391711|NCT01990209|BG001|Baseline|Cohort 2: AR+/HR+/HER2 +/- Tumors|Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
11391712|NCT01990209|BG002|Baseline|Total|Total of all reporting groups
10965931|NCT00884650|EG001|Reported Event|An Anesthetic Infusion Device With Supplement|Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
11198000|NCT02175758|FG002|Participant Flow|6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11391713|NCT01990209|FG000|Participant Flow|Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors|Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
11391714|NCT01990209|FG001|Participant Flow|Cohort 2: AR+/HR+/HER2 +/- Tumors|Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
11391715|NCT01990209|OG000|Outcome|Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors|Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
11391716|NCT01990209|OG001|Outcome|Cohort 2: AR+/HR+/HER2 +/- Tumors|Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
11391717|NCT01990209|EG000|Reported Event|Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors|Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/AR-positive (+) MBC with 1 to 3 previous treatments for metastatic disease
11391718|NCT01990209|EG001|Reported Event|Cohort 2: AR+/HR+/HER2 +/- Tumors|Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
11391719|NCT01958021|BG000|Baseline|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
11391720|NCT01958021|BG001|Baseline|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
11391721|NCT01958021|BG002|Baseline|Total|Total of all reporting groups
11391722|NCT01958021|FG000|Participant Flow|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
11391723|NCT01958021|FG001|Participant Flow|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
11391724|NCT01958021|OG000|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
11391725|NCT01958021|OG001|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
11391726|NCT01958021|EG000|Reported Event|Ribociclib 600mg + Letrozole 2.5mg|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
11391727|NCT01958021|EG001|Reported Event|Placebo + Letrozole 2.5mg|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
11391728|NCT01955109|BG000|Baseline|VIPES Initial Treatment Group: All Viaskin Peanut Doses|Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
11391729|NCT01955109|BG001|Baseline|VIPES Initial Treatment Group: Placebo|Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
11391730|NCT01955109|BG002|Baseline|Total|Total of all reporting groups
11198001|NCT02175758|FG003|Participant Flow|6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11198002|NCT02175758|FG004|Participant Flow|3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11198003|NCT02175758|FG005|Participant Flow|3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11198004|NCT02175758|OG000|Outcome|PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks|Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198005|NCT02175758|OG001|Outcome|PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks|Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198006|NCT02175758|OG002|Outcome|PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks|Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11391731|NCT01955109|FG000|Participant Flow|VIPES Initial Treatment Group: All Viaskin Peanut Doses|Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
11391732|NCT01955109|FG001|Participant Flow|VIPES Initial Treatment Group: Placebo|Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
11391733|NCT01955109|OG000|Outcome|VIPES Initial Treatment Group: All Viaskin Peanut Doses|Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
11391734|NCT01955109|OG001|Outcome|VIPES Initial Treatment Group: Placebo|Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
11391735|NCT01955109|EG000|Reported Event|VIPES Initial Treatment Group: All Viaskin Peanut Doses|Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
11391736|NCT01955109|EG001|Reported Event|VIPES Initial Treatment Group: Placebo|Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
11198007|NCT02175758|OG000|Outcome|12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11391737|NCT01935934|BG000|Baseline|Experimental (Endometriod + Serous)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391738|NCT01935934|BG001|Baseline|Exploratory (Uncommon Histology)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391739|NCT01935934|BG002|Baseline|Total|Total of all reporting groups
11391740|NCT01935934|FG000|Participant Flow|Experimental (Endometriod + Serous)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391741|NCT01935934|FG001|Participant Flow|Exploratory (Uncommon Histology)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391742|NCT01935934|OG000|Outcome|Experimental (Endometriod + Serous)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391743|NCT01935934|OG001|Outcome|Exploratory (Uncommon Histology)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391744|NCT01935934|OG000|Outcome|Endometrioid|"Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391745|NCT01935934|OG001|Outcome|Serous|"Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11241796|NCT02490293|OG001|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11391746|NCT01935934|OG002|Outcome|Carcinosarcoma|"Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391747|NCT01935934|OG003|Outcome|Other Histology|"Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391748|NCT01935934|EG000|Reported Event|Treatment (Cabozantinib S-malate)|"Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cabozantinib S-malate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11391749|NCT01902173|BG000|Baseline|Dabrafenib + GSK2141795 50 mg|Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily.
11391750|NCT01902173|BG001|Baseline|Dabrafenib + GSK2141795 75 mg|Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily
11391751|NCT01902173|BG002|Baseline|Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg|Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily.
11391752|NCT01902173|BG003|Baseline|Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg|Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily
11391753|NCT01902173|BG004|Baseline|Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg|Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily.
11391754|NCT01902173|BG005|Baseline|Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg|Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
11391755|NCT01902173|BG006|Baseline|Total|Total of all reporting groups
11391756|NCT01902173|FG000|Participant Flow|Dabrafenib + GSK2141795 50 mg|Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily.
11391757|NCT01902173|FG001|Participant Flow|Dabrafenib + GSK2141795 75 mg|Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily.
11391758|NCT01902173|FG002|Participant Flow|Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg|Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily.
11391759|NCT01902173|FG003|Participant Flow|Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg|Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily.
11391760|NCT01902173|FG004|Participant Flow|Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg|Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily.
11391761|NCT01902173|FG005|Participant Flow|Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg|Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
11391762|NCT01902173|OG000|Outcome|Phase 1 Doublet Regimen|All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib for 28 days in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle 1 and 50% of dabrafenib in Cycle 1
11391763|NCT01902173|OG000|Outcome|Phase 1 Triplet Regimen|All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib and trametinib for 28 days each in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle1 and 50% of dabrafenib and trametinib each in Cycle 1
11391764|NCT01902173|OG000|Outcome|Dabrafenib + GSK2141795 at MTD|Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
11391765|NCT01902173|OG000|Outcome|Dabrafenib + Trametinib + GSK2141795 at MTD|Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
11391766|NCT01902173|OG000|Outcome|GSK2141795 + Dabrafenib at the Phase I Determined MTD|Patients who received at least 1 dose of protocol therapy at the Phase I determined MTD
11391767|NCT01902173|OG000|Outcome|GSK2141795 + Dabrafenib + Trametinib at Phase I Determined MTD|Patients who received at least 1 dose of protocol therapy at the Phase I determined MTD
11391768|NCT01902173|OG000|Outcome|Dabrafenib + GSK2141795 at Phase I Determined MTD|Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
11391769|NCT01902173|OG000|Outcome|Dabrafenib + Trametinib + GSK2141795 at Phase I Determined MTD|Patients who received at least one dose of protocol therapy at the phase I determined MTD
11391770|NCT01902173|OG000|Outcome|Dabrafenib + GSK2141795 75 mg|All participants on the Phase II triplet combination of dabrafenib, trametinib and GSK2141795 MTD .
11391771|NCT01902173|EG000|Reported Event|Dabrafenib + GSK2141795 50 mg|Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GK2141795 once daily.
11391772|NCT01902173|EG001|Reported Event|Dabrafenib + GSK2141795 75 mg|Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GK2141795 once daily.
11391773|NCT01902173|EG002|Reported Event|Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg|Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25 mg of GK2141795 once daily.
11391774|NCT01902173|EG003|Reported Event|Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg|Triplet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 50 mg of GK2141795 once daily.
11391775|NCT01902173|EG004|Reported Event|Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg|Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75 mg of GK2141795 once daily.
11391776|NCT01902173|EG005|Reported Event|Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg|Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GK2141795 once daily.
11391777|NCT01854775|BG000|Baseline|Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg|HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391778|NCT01854775|BG001|Baseline|Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg|Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391779|NCT01854775|BG002|Baseline|Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg|Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391780|NCT01854775|BG003|Baseline|Total|Total of all reporting groups
11391781|NCT01854775|FG000|Participant Flow|Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg|Human immunodeficiency virus (HIV)-infected, antiretroviral (ARV) treatment-naive adolescents (12 to < 18 years of age) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391782|NCT01854775|FG001|Participant Flow|Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg|Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391783|NCT01854775|FG002|Participant Flow|Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg|Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391784|NCT01854775|OG000|Outcome|Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg|HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391785|NCT01854775|OG000|Outcome|Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg|Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391786|NCT01854775|OG000|Outcome|Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg|Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391787|NCT01854775|EG000|Reported Event|Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg|HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391788|NCT01854775|EG001|Reported Event|Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg|Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391789|NCT01854775|EG002|Reported Event|Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg|Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
11391790|NCT01849263|BG000|Baseline|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
11391791|NCT01849263|FG000|Participant Flow|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
11391792|NCT01849263|OG000|Outcome|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
11391793|NCT01849263|EG000|Reported Event|Treatment (Ibrutinib)|Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
11391794|NCT01841736|BG000|Baseline|Arm I (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391795|NCT01841736|BG001|Baseline|Arm II (Placebo)|Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
11391796|NCT01841736|BG002|Baseline|Total|Total of all reporting groups
11391797|NCT01841736|FG000|Participant Flow|Arm I (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391798|NCT01841736|FG001|Participant Flow|Arm II (Placebo)|Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
11391799|NCT01841736|OG000|Outcome|Arm I (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391800|NCT01841736|OG001|Outcome|Arm II (Placebo)|Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
11391801|NCT01841736|EG000|Reported Event|Arm I (Pazopanib Hydrochloride)|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391802|NCT01841736|EG001|Reported Event|Arm II (Placebo)|Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
11391803|NCT01841736|EG002|Reported Event|Placebo Crossover|Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride.
11391804|NCT01839331|BG000|Baseline|Ampion 4 mL Dose|4 mL Injection of Ampion
11391805|NCT01839331|BG001|Baseline|Placebo 4 mL Dose|4 mL Injection of Placebo
11391806|NCT01839331|BG002|Baseline|Ampion 10 mL Dose|10 mL Injection of Ampion
11391807|NCT01839331|BG003|Baseline|Placebo 10 mL Dose|10 mL Injection of Placebo
11391808|NCT01839331|BG004|Baseline|Total|Total of all reporting groups
11391809|NCT01839331|FG000|Participant Flow|Ampion 4 mL Dose|4 mL Injection of Ampion
11391810|NCT01839331|FG001|Participant Flow|Placebo 4 mL Dose|4 mL Injection of Placebo
11391811|NCT01839331|FG002|Participant Flow|Ampion 10 mL Dose|10 mL Injection of Ampion
11391812|NCT01839331|FG003|Participant Flow|Placebo 10 mL Dose|10 mL Injection of Placebo
11391813|NCT01839331|OG000|Outcome|Ampion Combined (4 mL & 10 mL Dose)|Combined results of 4 mL and 10 mL Ampion dose
11391814|NCT01839331|OG001|Outcome|Placebo Combined (4 mL and 10 mL Dose)|Combined results of 4 mL and 10 mL Placebo dose
11391815|NCT01839331|OG002|Outcome|Ampion 4 mL Dose|4 mL Injection of Ampion
11391816|NCT01839331|OG003|Outcome|Placebo 4 mL Dose|4 mL Injection of Placebo
11391817|NCT01839331|OG004|Outcome|Ampion 10 mL Dose|10 mL Injection of Ampion
11391818|NCT01839331|OG005|Outcome|Placebo 10 mL Dose|10 mL Injection of Placebo
11391819|NCT01839331|OG000|Outcome|Ampion Combined (4 mL and 10 mL) Dose|Combined results of 4 mL and 10 mL Ampion Dose
11391820|NCT01839331|OG001|Outcome|Placebo Combined (4 mL and 10 mL) Dose|Combined results of 4 mL and 10 mL Placebo dose results
11391821|NCT01839331|OG000|Outcome|Ampion Combined (4 mL and 10 mL) Dose|Combined results of 4 mL and 10 mL Ampion dose
11391822|NCT01839331|OG001|Outcome|Placebo Combined (4 mL and 10 mL) Dose|Combined results of 4 mL and 10 mL Placebo dose
11391823|NCT01839331|EG000|Reported Event|Ampion 4 mL Dose|4 mL Injection of Ampion
11391824|NCT01839331|EG001|Reported Event|Placebo 4 mL Dose|4 mL Injection of Placebo
11391825|NCT01839331|EG002|Reported Event|Ampion 10 mL Dose|10 mL Injection of Ampion
11391826|NCT01839331|EG003|Reported Event|Placebo 10 mL Dose|10 mL Injection of Placebo
11391827|NCT01835145|BG000|Baseline|Arm I (Cabozantinib-s-malate)|Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391828|NCT01835145|BG001|Baseline|Arm II (Temozolomide or Dacarbazine)|"Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. >>~>> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11391829|NCT01835145|BG002|Baseline|Total|Total of all reporting groups
11391830|NCT01835145|FG000|Participant Flow|Arm I (Cabozantinib-s-malate)|Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391831|NCT01835145|FG001|Participant Flow|Arm II (Temozolomide or Dacarbazine)|"Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11391832|NCT01835145|OG000|Outcome|Arm I (Cabozantinib-s-malate)|Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391833|NCT01835145|OG001|Outcome|Arm II (Temozolomide or Dacarbazine)|"Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~>~> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11391834|NCT01835145|OG001|Outcome|Arm II (Temozolomide or Dacarbazine)|"Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity."
11391835|NCT01835145|EG000|Reported Event|Arm I (Cabozantinib-s-malate)|Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11198008|NCT02175758|OG001|Outcome|12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198009|NCT02175758|OG002|Outcome|6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11391836|NCT01835145|EG001|Reported Event|Arm II (Temozolomide)|Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11391837|NCT01835145|EG002|Reported Event|Arm II (Dacarbazine)|Patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11391838|NCT01709123|BG000|Baseline|Placebo|"Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.~placebo: Placebo pill for chromium niacinate"
11391839|NCT01709123|BG001|Baseline|Chromium Niacinate|"Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period~chromium niacinate: 200ug or 500ug supplementation in pill form"
11391840|NCT01709123|BG002|Baseline|Total|Total of all reporting groups
11391841|NCT01709123|FG000|Participant Flow|Placebo|"Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.~placebo: Placebo pill for chromium niacinate"
11391842|NCT01709123|FG001|Participant Flow|Chromium Niacinate|"Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period~chromium niacinate: 200ug or 500ug supplementation in pill form"
11391843|NCT01709123|OG000|Outcome|Placebo|"Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.~placebo: Placebo pill for chromium niacinate"
11391844|NCT01709123|OG001|Outcome|Chromium Niacinate|"Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period~chromium niacinate: 200ug or 500ug supplementation in pill form"
11391845|NCT01709123|EG000|Reported Event|Placebo|"Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.~placebo: Placebo pill for chromium niacinate"
11391846|NCT01709123|EG001|Reported Event|Chromium Niacinate|"Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period~chromium niacinate: 200ug or 500ug supplementation in pill form"
11391847|NCT01235234|BG000|Baseline|CF101 0.1 mg|CF101: orally q12h
11391848|NCT01235234|BG001|Baseline|CF101 1 mg|CF101: orally q12h
11391849|NCT01235234|BG002|Baseline|Placebo|CF101: orally q12h
11391850|NCT01235234|BG003|Baseline|Total|Total of all reporting groups
11391851|NCT01235234|FG000|Participant Flow|CF101 0.1 mg|CF101: orally q12h
11391852|NCT01235234|FG001|Participant Flow|CF101 1 mg|CF101: orally q12h
11391853|NCT01235234|FG002|Participant Flow|Placebo|CF101: orally q12h
11391854|NCT01235234|OG000|Outcome|CF101 0.1 mg|CF101: orally q12h
11391855|NCT01235234|OG001|Outcome|CF101 1 mg|CF101: orally q12h
11391856|NCT01235234|OG002|Outcome|Placebo|CF101: orally q12h
11391857|NCT01235234|EG000|Reported Event|CF101 0.1 mg|CF101: orally q12h
11391858|NCT01235234|EG001|Reported Event|CF101 1 mg|CF101: orally q12h
11391859|NCT01235234|EG002|Reported Event|Placebo|CF101: orally q12h
11391860|NCT01160211|BG000|Baseline|Lapatinib+Trastuzumab+Al|lapatinib (1000mg) plus trastuzumab (6mg/kg) plus an AI (Aromatase Inhibitors)
11391861|NCT01160211|BG001|Baseline|Lapatinib+AI|Lapatinib (1500mg) plus AI (Aromatase Inhibitors)
11391862|NCT01160211|BG002|Baseline|Trastuzumab+AI|Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)
11391863|NCT01160211|BG003|Baseline|Total|Total of all reporting groups
11391864|NCT01160211|FG000|Participant Flow|Lapatinib+Trastuzumab+Al|lapatinib (1000mg) plus trastuzumab (6mg/kg) plus an AI (Aromatase Inhibitors)
11391865|NCT01160211|FG001|Participant Flow|Lapatinib+AI|Lapatinib (1500mg) plus AI (Aromatase Inhibitors)
11391866|NCT01160211|FG002|Participant Flow|Trastuzumab+AI|Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)
11391867|NCT01160211|OG000|Outcome|Lapatinib+Trastuzumab+Al|lapatinib (1000mg) plus trastuzumab (6mg/kg) plus an AI (Aromatase Inhibitors)
11198010|NCT02175758|OG003|Outcome|6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198011|NCT02175758|OG004|Outcome|3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198012|NCT02175758|OG005|Outcome|3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11391868|NCT01160211|OG001|Outcome|Trastuzumab+AI|Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)
11391869|NCT01160211|OG001|Outcome|Lapatinib+AI|Lapatinib (1500mg) plus AI (Aromatase Inhibitors)
11391870|NCT01160211|OG002|Outcome|Trastuzumab+AI|Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)
11391871|NCT01160211|EG000|Reported Event|Lapatinib+Trastuzumab+Al|lapatinib (1000mg) plus trastuzumab (6mg/kg) plus an AI (Aromatase Inhibitors)
11391872|NCT01160211|EG001|Reported Event|Lapatinib+AI|Lapatinib (1500mg) plus AI (Aromatase Inhibitors)
11391873|NCT01160211|EG002|Reported Event|Trastuzumab+AI|Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)
11391874|NCT01093573|BG000|Baseline|Dose Level 1|Aza at 75 mg/m2 D1-7 & Midostaurin 25 mg BID D 8-21
11391875|NCT01093573|BG001|Baseline|Dose Level 2|Aza at 75 mg/m2 D1-7 & Midostaurin 50 mg BID D 8-21
11391876|NCT01093573|BG002|Baseline|Dose Level 3|Azacitidine 75 mg/m2 IV D1-7 & Midostaurin 75 mg PO BID D 8-21
11391877|NCT01093573|BG003|Baseline|Total|Total of all reporting groups
11391878|NCT01093573|FG000|Participant Flow|Dose Level 1|"Aza at 75 mg/m2 D1-7 & Midostaurin 25 mg BID D 8-21~midostaurin: Given orally~azacitidine: Given IV~bone marrow aspiration"
11391879|NCT01093573|FG001|Participant Flow|Dose Level 2|Aza at 75 mg/m2 D1-7 & Midostaurin 50 mg BID D 8-21
11391880|NCT01093573|FG002|Participant Flow|Dose Level 3|Azacitidine 75 mg/m2 IV D1-7 & Midostaurin 75 mg PO BID D 8-21
11391881|NCT01093573|OG000|Outcome|Midostaurin Dose Escalation|"Patients receive Azacitidine at 75 mg/m2 D1-7 & Midostaurin (25 mg bid, 50 mg bid, and 75 mg bid) mg BID D 8-21~midostaurin: Given orally~azacitidine: Given IV"
11391882|NCT01093573|OG000|Outcome|Dose Level 1|"Patients receive azacitidine at 75 mg/m2 D1-7 & Midostaurin 25 mg BID D 8-21~midostaurin: Given orally~azacitidine: Given IV~."
11391883|NCT01093573|OG001|Outcome|Dose Level 2|Patients receive azacitidine at 75 mg/m2 D1-7 & Midostaurin 50 mg BID D 8-21
11391884|NCT01093573|OG002|Outcome|Dose Level 3|Patients receive azacitidine at 75 mg/m2 D1-7 & Midostaurin 75mg BID D 8-21
11391885|NCT01093573|OG000|Outcome|Dose Level 3|"Patients receive azacitidine at 75 mg/m2 D1-7 & Midostaurin 75 mg BID D 8-21~midostaurin: Given orally~azacitidine: Given IV"
11391886|NCT01093573|OG000|Outcome|Azacitidine and Midostaurin|"Patients receive azacitidine IV over 10-20 minutes on days 1-7 and oral midostaurin twice daily on days 8-21.~midostaurin: Given orally~azacitidine: Given IV~bone marrow aspiration: Correlative study: Pretreatment bone marrow aspirates or blood [(3 ml in EDTA tube (purple top)] will be analyzed according to local institution guidelines to determine whether blasts contain wild type Flt3, ITD, or Flt 3 mutations.~mutation analysis: Correlative study~Pharmacokinetic study: Correlative study: Concentrations of unchanged midostaurin and its major metabolites, CGP52421 and CGP62221 in plasma samples will be determined using a validated liquid chromatography / mass spectrometry method."
11391887|NCT01093573|EG000|Reported Event|Dose Level 1|"Patients receive azacitidine IV over 10-20 minutes on days 1-7 and oral midostaurin twice daily on days 8-21.~midostaurin: Given orally~azacitidine: Given IV"
11391888|NCT01093573|EG001|Reported Event|Dose Level 2|"Patients receive azacitidine IV over 10-20 minutes on days 1-7 and oral midostaurin twice daily on days 8-21.~midostaurin: Given orally~azacitidine: Given IV"
11391889|NCT01093573|EG002|Reported Event|Dose Level 3|"Patients receive azacitidine IV over 10-20 minutes on days 1-7 and oral midostaurin twice daily on days 8-21.~midostaurin: Given orally~azacitidine: Given IV"
11391890|NCT00828854|BG000|Baseline|Entinostat 5 mg + AI|Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
11391891|NCT00828854|FG000|Participant Flow|Entinostat 5 mg + AI|Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
11391892|NCT00828854|OG000|Outcome|Entinostat 5 mg + AI|Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
11391893|NCT00828854|EG000|Reported Event|Entinostat 5 mg + AI|Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
11391894|NCT00753545|BG000|Baseline|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
11391895|NCT00753545|BG001|Baseline|Placebo bd|olaparib matching placebo oral capsules twice daily
11391896|NCT00753545|BG002|Baseline|Total|Total of all reporting groups
11391897|NCT00753545|FG000|Participant Flow|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
11391898|NCT00753545|FG001|Participant Flow|Placebo bd|olaparib matching placebo oral capsules twice daily
11391899|NCT00753545|OG000|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
11391900|NCT00753545|OG001|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
11391901|NCT00753545|EG000|Reported Event|Olaparib 400 mg bd|
11391902|NCT00753545|EG001|Reported Event|Placebo|
11391903|NCT00494234|BG000|Baseline|AZD2281 100 mg|
11391904|NCT00494234|BG001|Baseline|AZD2281 400 mg|
10965932|NCT00884741|BG000|Baseline|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
11391905|NCT00494234|BG002|Baseline|Total|Total of all reporting groups
11391906|NCT00494234|FG000|Participant Flow|Olaparib 100 mg bd|Full Analysis Set
11391907|NCT00494234|FG001|Participant Flow|Olaparib 400 mg bd|Full Analysis Set
11391908|NCT00494234|OG000|Outcome|Olaparib 100 mg bd|Per Protocol Set
11391909|NCT00494234|OG001|Outcome|Olaparib 400 mg bd|Per Protocol Set
11391910|NCT00494234|OG000|Outcome|Olaparib 100 mg bd|Number of responders
11391911|NCT00494234|OG001|Outcome|Olaparib 400 mg bd|Number of responders
11391912|NCT00494234|OG000|Outcome|Olaparib 100 mg bd|Patients who compled 6 cycles of treatment
11391913|NCT00494234|OG001|Outcome|Olaparib 400 mg bd|Patients who compled 6 cycles of treatment
11391914|NCT00494234|EG000|Reported Event|AZD2281 100 mg|
11391915|NCT00494234|EG001|Reported Event|AZD2281 400 mg|
11198013|NCT02175758|OG000|Outcome|12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks|Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198014|NCT02175758|OG001|Outcome|3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks|"Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.~Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks."
11198015|NCT02175758|OG002|Outcome|12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198016|NCT02175758|OG003|Outcome|12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198017|NCT02175758|OG004|Outcome|6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198018|NCT02175758|OG005|Outcome|6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198019|NCT02175758|OG006|Outcome|3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198020|NCT02175758|OG007|Outcome|3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198021|NCT02175758|OG000|Outcome|PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11241797|NCT02490293|EG000|Reported Event|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11241798|NCT02490293|EG001|Reported Event|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11241799|NCT02490371|BG000|Baseline|(1) rTMS- PT Ex Group|"1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.~After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
11241800|NCT02490371|BG001|Baseline|(2) Placebo- PT Ex Group|"placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.~Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
11241801|NCT02490371|BG002|Baseline|Total|Total of all reporting groups
11241802|NCT02490371|FG000|Participant Flow|(1) rTMS- PT Ex Group|"1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.~After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
11241803|NCT02490371|FG001|Participant Flow|(2) Placebo- PT Ex Group|"placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.~Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
11241804|NCT02490371|OG000|Outcome|rTMS Group + Exercise|Patient with rTMS and 30 minutes exercise
11241805|NCT02490371|OG001|Outcome|Placebo+ Exercise|Placebo stimulation with exercise
11241806|NCT02490371|EG000|Reported Event|(1) rTMS- PT Ex Group|"1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.~After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
11241807|NCT02490371|EG001|Reported Event|(2) Placebo- PT Ex Group|"placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.~Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).~Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.~structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes"
10965933|NCT00884741|BG001|Baseline|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
11198022|NCT02175758|OG001|Outcome|PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198023|NCT02175758|OG002|Outcome|PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
10965934|NCT00884741|BG002|Baseline|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
11198024|NCT02175758|OG003|Outcome|PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198025|NCT02175758|OG004|Outcome|PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198026|NCT02175758|OG005|Outcome|PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198027|NCT02175758|OG000|Outcome|12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks|Male participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198028|NCT02175758|OG001|Outcome|6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks|Male participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198029|NCT02175758|OG002|Outcome|3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks|Male participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198030|NCT02175758|OG000|Outcome|12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks|Female participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198031|NCT02175758|OG001|Outcome|6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks|Female participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198032|NCT02175758|OG002|Outcome|3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks|Female participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198033|NCT02175758|OG000|Outcome|12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks|Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198034|NCT02175758|OG001|Outcome|6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks|Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198035|NCT02175758|OG002|Outcome|3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks|Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
11198036|NCT02175758|EG000|Reported Event|12 to < 18 Years Old - SOF+RBV 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198037|NCT02175758|EG001|Reported Event|12 to < 18 Years Old - SOF+RBV 24 Weeks|Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198038|NCT02175758|EG002|Reported Event|6 to < 12 Years Old - SOF+RBV 12 Weeks|Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198039|NCT02175758|EG003|Reported Event|6 to < 12 Years Old - SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198040|NCT02175758|EG004|Reported Event|3 to < 6 Years Old - SOF+RBV 12 Weeks|Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
11198041|NCT02175758|EG005|Reported Event|3 to < 6 Years Old - SOF+RBV 24 Weeks|Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
11198042|NCT02175771|BG000|Baseline|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198043|NCT02175771|BG001|Baseline|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198044|NCT02175771|BG002|Baseline|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198045|NCT02175771|BG003|Baseline|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10965935|NCT00884741|BG003|Baseline|Total|Total of all reporting groups
10800145|NCT02513667|BG001|Baseline|Patients Recieved Prior ALK Inhibitor|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10800146|NCT02513667|BG002|Baseline|Total|Total of all reporting groups
10800147|NCT02513667|FG000|Participant Flow|ALK-inhibitor Naive Patients|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10800148|NCT02513667|FG001|Participant Flow|Patients Recieved Prior ALK Inhibitor|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10800149|NCT02513667|OG000|Outcome|ALK-inhibitor Naive Patients|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10800150|NCT02513667|OG001|Outcome|Patients Recieved Prior ALK Inhibitor|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10800151|NCT02513667|EG000|Reported Event|ALK-inhibitor Naive Patients|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
10850755|NCT00304265|OG001|Outcome|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
11198046|NCT02175771|BG004|Baseline|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198047|NCT02175771|BG005|Baseline|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198048|NCT02175771|BG006|Baseline|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198049|NCT02175771|BG007|Baseline|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800152|NCT02513667|EG001|Reported Event|Patients Recieved Prior ALK Inhibitor|"Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months.~Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.~Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination)."
11198050|NCT02175771|BG008|Baseline|Total|Total of all reporting groups
11198051|NCT02175771|FG000|Participant Flow|Enrolled Patients|During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
11198052|NCT02175771|FG001|Participant Flow|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198053|NCT02175771|FG002|Participant Flow|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198054|NCT02175771|FG003|Participant Flow|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198055|NCT02175771|FG004|Participant Flow|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198056|NCT02175771|FG005|Participant Flow|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198057|NCT02175771|FG006|Participant Flow|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198058|NCT02175771|FG007|Participant Flow|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11340762|NCT03663283|BG001|Baseline|Plain Bupivacaine|"Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Bupivacaine Hydrochloride: Interscalene Nerve Blocks"
11340763|NCT03663283|BG002|Baseline|Total|Total of all reporting groups
11340764|NCT03663283|FG000|Participant Flow|Liposomal Bupivacaine|"Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Liposomal Bupivacaine: Interscalene Nerve Blocks"
11340765|NCT03663283|FG001|Participant Flow|Plain Bupivacaine|"Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Bupivacaine Hydrochloride: Interscalene Nerve Blocks"
11340766|NCT03663283|OG000|Outcome|Liposomal Bupivacaine|"Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Liposomal Bupivacaine: Interscalene Nerve Blocks"
11340767|NCT03663283|OG001|Outcome|Plain Bupivacaine|"Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Bupivacaine Hydrochloride: Interscalene Nerve Blocks"
11340768|NCT03663283|EG000|Reported Event|Liposomal Bupivacaine|"Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Liposomal Bupivacaine: Interscalene Nerve Blocks"
11340769|NCT03663283|EG001|Reported Event|Plain Bupivacaine|"Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.~Bupivacaine Hydrochloride: Interscalene Nerve Blocks"
11340770|NCT03663569|BG000|Baseline|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
11340771|NCT03663569|FG000|Participant Flow|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
11340772|NCT03663569|OG000|Outcome|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
11340773|NCT03663569|EG000|Reported Event|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
11340774|NCT03663582|BG000|Baseline|Teduglutide|Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
11340775|NCT03663582|FG000|Participant Flow|Teduglutide|Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
11340776|NCT03663582|OG000|Outcome|Teduglutide|Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
11340777|NCT03663582|EG000|Reported Event|Teduglutide|Participants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.
11340778|NCT03663816|BG000|Baseline|Healthy Men and Women|"Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device~experimental foot device: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people."
11340779|NCT03663816|FG000|Participant Flow|Healthy Men and Women|"Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device~experimental foot device: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people."
11340780|NCT03663816|OG000|Outcome|Healthy Men and Women|"Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device~experimental foot device: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people."
11340781|NCT03663816|EG000|Reported Event|Healthy Men and Women|"Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device~experimental foot device: Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people."
11340782|NCT03664193|BG000|Baseline|Single Arm|"Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.~SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy."
11340783|NCT03664193|FG000|Participant Flow|Single Arm|"Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.~SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy."
11340784|NCT03664193|OG000|Outcome|Single Arm|"Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.~SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy."
11340785|NCT03664193|EG000|Reported Event|Single Arm|"Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.~SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy."
11340786|NCT03664544|BG000|Baseline|HP PK MCI-186|Subjects with severe hepatic impairment
11340787|NCT03664544|BG001|Baseline|NHV PK MCI-186|Subjects with normal hepatic function
11340788|NCT03664544|BG002|Baseline|Total|Total of all reporting groups
11340789|NCT03664544|FG000|Participant Flow|HP PK MCI-186|Subjects with severe hepatic impairment
11340790|NCT03664544|FG001|Participant Flow|NHV PK MCI-186|Subjects with normal hepatic function
11340791|NCT03664544|OG000|Outcome|HP PK MCI-186|Subjects with severe hepatic impairment
11340792|NCT03664544|OG001|Outcome|NHV PK MCI-186|Subjects with normal hepatic function
11340793|NCT03664544|EG000|Reported Event|HP PK MCI-186|Subjects with severe hepatic impairment
11340794|NCT03664544|EG001|Reported Event|NHV PK MCI-186|Subjects with normal hepatic function
11340795|NCT03665155|BG000|Baseline|Phase I: Dose Escalation 1-5 mCi in 50mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 50mg of antibody
11340796|NCT03665155|BG001|Baseline|Phase I: Dose Escalation 1-5 mCi in 20mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 20mg of antibody
11340797|NCT03665155|BG002|Baseline|Phase I: Dose Escalation 1-5 mCi in 3-50mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 3-50mg of antibody
11340798|NCT03665155|BG003|Baseline|Total|Total of all reporting groups
11340799|NCT03665155|FG000|Participant Flow|Phase I: Dose Escalation 1-5 mCi in 50mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 50mg of antibody
11340800|NCT03665155|FG001|Participant Flow|Phase I: Dose Escalation 1-5 mCi in 20mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 20mg of antibody
11340801|NCT03665155|FG002|Participant Flow|Phase I: Dose Escalation 1-5 mCi in 3-50mg of Antibody|Phase I: Dose Escalation 1-5 mCi in 3-50mg of antibody
11340802|NCT03665155|OG000|Outcome|89Zr-daratumumab|The Phase I portion of the study has concluded. The Phase II portion has not yet opened to accrual.
10800170|NCT02415556|BG000|Baseline|Type 2 Diabetes Mellitus - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800171|NCT02415556|BG001|Baseline|Type 2 Diabetes Mellitus - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
10800172|NCT02415556|BG002|Baseline|Control - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800173|NCT02415556|BG003|Baseline|Control - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
10800174|NCT02415556|BG004|Baseline|Total|Total of all reporting groups
10800175|NCT02415556|FG000|Participant Flow|Type 2 Diabetes Mellitus - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800176|NCT02415556|FG001|Participant Flow|Type 2 Diabetes Mellitus - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
10800177|NCT02415556|FG002|Participant Flow|Control - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800178|NCT02415556|FG003|Participant Flow|Control - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
10800179|NCT02415556|OG000|Outcome|Type 2 Diabetes Mellitus - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
11198059|NCT02175771|FG008|Participant Flow|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800180|NCT02415556|OG001|Outcome|Type 2 Diabetes Mellitus - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
10800181|NCT02415556|OG002|Outcome|Control - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800182|NCT02415556|OG003|Outcome|Control - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
11198060|NCT02175771|OG000|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198061|NCT02175771|OG001|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
10800183|NCT02415556|EG000|Reported Event|Type 2 Diabetes Mellitus - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
11241808|NCT02490475|BG000|Baseline|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241809|NCT02490475|BG001|Baseline|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241810|NCT02490475|BG002|Baseline|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241811|NCT02490475|BG003|Baseline|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241812|NCT02490475|BG004|Baseline|Total|Total of all reporting groups
11241813|NCT02490475|FG000|Participant Flow|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241814|NCT02490475|FG001|Participant Flow|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241815|NCT02490475|FG002|Participant Flow|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241816|NCT02490475|FG003|Participant Flow|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241817|NCT02490475|OG000|Outcome|Entire Study Population|Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
11241818|NCT02490475|OG000|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11241819|NCT02490475|OG001|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11241820|NCT02490475|OG002|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11241821|NCT02490475|OG000|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
10800184|NCT02415556|EG001|Reported Event|Type 2 Diabetes Mellitus - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
11241822|NCT02490475|OG001|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241823|NCT02490475|OG002|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241824|NCT02490475|OG003|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241825|NCT02490475|OG000|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241826|NCT02490475|OG001|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241827|NCT02490475|OG002|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241828|NCT02490475|OG003|Outcome|Docetaxel 75+ Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241829|NCT02490475|OG004|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241830|NCT02490475|OG005|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241831|NCT02490475|OG003|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241832|NCT02490475|EG000|Reported Event|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
10965936|NCT00884741|FG000|Participant Flow|Step 1 Registration|No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
11241833|NCT02490475|EG001|Reported Event|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241834|NCT02490475|EG002|Reported Event|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241835|NCT02490475|EG003|Reported Event|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11241836|NCT02490631|BG000|Baseline|Standard of Care Pre-operative Cleansing|Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
11241837|NCT02490631|BG001|Baseline|2% Chlorhexidine Gluconate|"2% chlorhexidine gluconate cloths the night before and morning of surgery~2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths"
11241838|NCT02490631|BG002|Baseline|Total|Total of all reporting groups
11241839|NCT02490631|FG000|Participant Flow|Standard of Care Pre-operative Cleansing|Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
11241840|NCT02490631|FG001|Participant Flow|2% Chlorhexidine Gluconate|"2% chlorhexidine gluconate cloths the night before and morning of surgery~2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths"
11241841|NCT02490631|OG000|Outcome|Standard of Care Pre-operative Cleansing|Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
11241842|NCT02490631|OG001|Outcome|2% Chlorhexidine Gluconate|"2% chlorhexidine gluconate cloths the night before and morning of surgery~2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths"
11241843|NCT02490631|EG000|Reported Event|Standard of Care Pre-operative Cleansing|Standard of care pre-operative cleansing with soap and water the night before and morning of surgery
11241844|NCT02490631|EG001|Reported Event|2% Chlorhexidine Gluconate|"2% chlorhexidine gluconate cloths the night before and morning of surgery~2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths"
11241845|NCT02490670|BG000|Baseline|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
11241846|NCT02490670|BG001|Baseline|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).
11241847|NCT02490670|BG002|Baseline|Total|Total of all reporting groups
11241848|NCT02490670|FG000|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
11241849|NCT02490670|FG001|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).
11241850|NCT02490670|OG000|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11241851|NCT02490670|OG001|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
11241852|NCT02490670|EG000|Reported Event|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11241853|NCT02490670|EG001|Reported Event|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
11241854|NCT02490878|BG000|Baseline|Arm A: Bevacizumab|The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241855|NCT02490878|BG001|Baseline|Arm B: Placebo|The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241856|NCT02490878|BG002|Baseline|Total|Total of all reporting groups
11241857|NCT02490878|FG000|Participant Flow|Arm A: Bevacizumab|The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
10800185|NCT02415556|EG002|Reported Event|Control - Insulin|"40 IU of regular human insulin once daily over 24 weeks~Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks"
10800186|NCT02415556|EG003|Reported Event|Control - Placebo|"Intranasal sterile saline once daily over 24 weeks~Placebo: Intranasal sterile saline 40 IU daily over 24 weeks"
11241858|NCT02490878|FG001|Participant Flow|Arm B: Placebo|The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241859|NCT02490878|OG000|Outcome|Arm A: Bevacizumab|The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241860|NCT02490878|OG001|Outcome|Arm B: Placebo|The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241861|NCT02490878|EG000|Reported Event|Arm A: Bevacizumab|The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241862|NCT02490878|EG001|Reported Event|Arm B: Placebo|The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
11241863|NCT02491073|BG000|Baseline|Eslicarbazepine Acetate Treated|blood draw: Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
11241864|NCT02491073|BG001|Baseline|Non-Eslicarbazepine Acetate Treated|blood draw: Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
11241865|NCT02491073|BG002|Baseline|Total|Total of all reporting groups
11241866|NCT02491073|FG000|Participant Flow|Eslicarbazepine Acetate Exposed Subjects|Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
11241867|NCT02491073|FG001|Participant Flow|Healthy Volunteers|Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
11241868|NCT02491073|OG000|Outcome|Automated Kit Assay (AK) - ESL-exposed Subjects|Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
11241869|NCT02491073|OG001|Outcome|Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects|Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
11241870|NCT02491073|OG000|Outcome|Non-spiked Serum(NS) Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was not spiked with ESL metabolites
11241871|NCT02491073|OG001|Outcome|Low-spiked Serum(LS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
11241872|NCT02491073|OG002|Outcome|Mid-spiked Serum(MS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
11241873|NCT02491073|OG003|Outcome|High-spiked Serum(HS)Healthy Volunteers|Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
11241874|NCT02491073|OG000|Outcome|Non-spiked Serum(NS) Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was not spiked with ESL metabolites
11241875|NCT02491073|OG001|Outcome|Low-spiked Serum(LS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
11241876|NCT02491073|OG002|Outcome|Mid-spiked Serum(MS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
11241877|NCT02491073|OG003|Outcome|High-spiked Serum(HS)Healthy Volunteers|thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
11241878|NCT02491073|OG000|Outcome|Automated Kit Assay(AK)Non-spiked Serum(NS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was not spiked with ESL metabolites
11241879|NCT02491073|OG001|Outcome|Optimized Equilibrium Dialysis Method(ED)(NS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was not spiked with ESL metabolites
11241880|NCT02491073|OG002|Outcome|Automated Kit Assay(AK)Low-spiked Serum(LS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
11241881|NCT02491073|OG003|Outcome|Optimized Equilibrium Dialysis Method(ED)(LS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with low level of ESL metabolites
10800187|NCT02389374|BG000|Baseline|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
11198062|NCT02175771|OG002|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198063|NCT02175771|OG003|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198064|NCT02175771|OG004|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198065|NCT02175771|OG005|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198066|NCT02175771|OG006|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198067|NCT02175771|OG007|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198068|NCT02175771|EG000|Reported Event|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198069|NCT02175771|EG001|Reported Event|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198070|NCT02175771|EG002|Reported Event|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198071|NCT02175771|EG003|Reported Event|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198072|NCT02175771|EG004|Reported Event|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198073|NCT02175771|EG005|Reported Event|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198074|NCT02175771|EG006|Reported Event|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11198075|NCT02175771|EG007|Reported Event|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
11241882|NCT02491073|OG004|Outcome|Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
11241883|NCT02491073|OG005|Outcome|Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
10800188|NCT02389374|BG001|Baseline|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
10800189|NCT02389374|BG002|Baseline|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
10800190|NCT02389374|BG003|Baseline|Total|Total of all reporting groups
10800191|NCT02389374|FG000|Participant Flow|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
10965937|NCT00884741|FG001|Participant Flow|Step 2 Registration: Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization
11241884|NCT02491073|OG006|Outcome|Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers|Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
11241885|NCT02491073|OG007|Outcome|Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer|Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
11241886|NCT02491073|EG000|Reported Event|Eslicarbazepine Acetate Exposed Subjects|Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
11241887|NCT02491073|EG001|Reported Event|Healthy Volunteers|Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
11241888|NCT02491359|BG000|Baseline|Treatment (Carfilzomib)|Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11241889|NCT02491359|FG000|Participant Flow|Treatment (Carfilzomib)|Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11241890|NCT02491359|OG000|Outcome|Treatment (Carfilzomib)|Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11241891|NCT02491359|OG000|Outcome|Response Evaluated by MD|Participants who receive carfilzomib
11241892|NCT02491359|OG001|Outcome|Response Evaluated by NIH|Participants who receive carfilzomib
11241893|NCT02491359|EG000|Reported Event|Treatment (Carfilzomib)|Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11241894|NCT02491437|BG000|Baseline|Dydrogesterone Tablets 3x10 mg|"Dydrogesterone tablets 3x10 mg~Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid"
11241895|NCT02491437|BG001|Baseline|Crinone 8% Intravaginal Progesterone Gel 90 mg|"Crinone 8% intravaginal progesterone gel 90 mg~intravaginal progesterone gel 90 mg OD"
11241896|NCT02491437|BG002|Baseline|Total|Total of all reporting groups
11241897|NCT02491437|FG000|Participant Flow|Dydrogesterone Tablets 3x10 mg|"Dydrogesterone tablets 3x10 mg~Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid"
11241898|NCT02491437|FG001|Participant Flow|Crinone 8% Intravaginal Progesterone Gel 90 mg|"Crinone 8% intravaginal progesterone gel 90 mg~intravaginal progesterone gel 90 mg OD"
11241899|NCT02491437|OG000|Outcome|Dydrogesterone Tablets 3x10 mg|"Dydrogesterone tablets 3x10 mg~Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid"
11241900|NCT02491437|OG001|Outcome|Crinone 8% Intravaginal Progesterone Gel 90 mg|"Crinone 8% intravaginal progesterone gel 90 mg~intravaginal progesterone gel 90 mg OD"
11241901|NCT02491437|EG000|Reported Event|Dydrogesterone Tablets 3x10 mg (Maternal)|"Dydrogesterone tablets 3x10 mg~Dydrogesterone 30 mg: Oral Dydrogesterone 10 mg tablets tid"
11241902|NCT02491437|EG001|Reported Event|Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal)|"Crinone 8% intravaginal progesterone gel 90 mg~Intravaginal progesterone gel 90 mg OD"
11241903|NCT02491437|EG002|Reported Event|Dydrogesterone Tablets (Fetus/Newborn)|"Maternal dosing of Dydrogesterone tablets 3x10 mg~221 subjects at risk=205 live births + 16 abortions/stillbirths"
11241904|NCT02491437|EG003|Reported Event|Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn)|"Maternal dosing of Crinone 8% intravaginal progesterone gel 90 mg~201 subjects at risk = 188 live births + 13 abortions/stillbirths"
11241905|NCT02491463|BG000|Baseline|GSK3389245A_LD Group|Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
11241906|NCT02491463|BG001|Baseline|GSK3389245A_HD Group|Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
11241907|NCT02491463|BG002|Baseline|Placebo Group|Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
11241908|NCT02491463|BG003|Baseline|Bexsero Group|Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
11241909|NCT02491463|BG004|Baseline|Total|Total of all reporting groups
11241910|NCT02491463|FG000|Participant Flow|GSK3389245A_LD Group|Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
11241911|NCT02491463|FG001|Participant Flow|GSK3389245A_HD Group|Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
11241912|NCT02491463|FG002|Participant Flow|Placebo Group|Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
11241913|NCT02491463|FG003|Participant Flow|Bexsero Group|Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
11241914|NCT02491463|OG000|Outcome|GSK3389245A_LD Group|Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
11241915|NCT02491463|OG001|Outcome|GSK3389245A_HD Group|Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
11241916|NCT02491463|OG002|Outcome|Placebo Group|Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
11241917|NCT02491463|OG003|Outcome|Bexsero Group|Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
11241918|NCT02491463|EG000|Reported Event|GSK3389245A_LD Group|Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
11241919|NCT02491463|EG001|Reported Event|GSK3389245A_HD Group|Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
11241920|NCT02491463|EG002|Reported Event|Placebo Group|Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
11241921|NCT02491463|EG003|Reported Event|Bexsero Group|Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
10800192|NCT02389374|FG001|Participant Flow|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
10800193|NCT02389374|FG002|Participant Flow|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
11241922|NCT02491671|BG000|Baseline|Experimental Group|"Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.~Hemopatch~standard preventive measures"
11241923|NCT02491671|BG001|Baseline|Control Group|"Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat~standard preventive measures"
11241924|NCT02491671|BG002|Baseline|Total|Total of all reporting groups
11241925|NCT02491671|FG000|Participant Flow|Experimental Group|"Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.~Hemopatch~standard preventive measures"
11241926|NCT02491671|FG001|Participant Flow|Control Group|"Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat~standard preventive measures"
11241927|NCT02491671|OG000|Outcome|Experimental Group|"Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.~Hemopatch~standard preventive measures"
11241928|NCT02491671|OG001|Outcome|Control Group|"Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat~standard preventive measures"
11241929|NCT02491671|EG000|Reported Event|Experimental Group|"Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.~Hemopatch~standard preventive measures"
11241930|NCT02491671|EG001|Reported Event|Control Group|"Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat~standard preventive measures"
11241931|NCT02491684|BG000|Baseline|AZD9412|"Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.~Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
11241932|NCT02491684|BG001|Baseline|Placebo|"Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
10800194|NCT02389374|OG000|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
11241933|NCT02491684|BG002|Baseline|Total|Total of all reporting groups
11241934|NCT02491684|FG000|Participant Flow|AZD9412|"Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.~Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home."
11241935|NCT02491684|FG001|Participant Flow|Placebo|"Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
10800195|NCT02389374|OG001|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
10800196|NCT02389374|OG002|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
10800197|NCT02389374|OG000|Outcome|All Malaria Patients|single Arm/Group for all participants
11198076|NCT02175966|BG000|Baseline|4 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198077|NCT02175966|BG001|Baseline|6 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
10800198|NCT02389374|EG000|Reported Event|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines~chloroquine: standard dose~Primaquine: 14 days"
11198078|NCT02175966|BG002|Baseline|Total|Total of all reporting groups
11198079|NCT02175966|FG000|Participant Flow|4 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198080|NCT02175966|FG001|Participant Flow|6 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198081|NCT02175966|OG000|Outcome|4 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11241936|NCT02491684|OG000|Outcome|AZD9412|"Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.~Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
11241937|NCT02491684|OG001|Outcome|Placebo|"Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
11241938|NCT02491684|EG000|Reported Event|AZD9412|"Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.~Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home."
11241939|NCT02491684|EG001|Reported Event|Placebo|"Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.~Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.~Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home."
11241940|NCT02491788|BG000|Baseline|Drug|"10 mg of suvorexant 30 minutes prior to daytime sleep opportunity~Suvorexant"
11241941|NCT02491788|BG001|Baseline|Placebo|"Placebo pill 30 minutes prior to daytime sleep opportunity~Placebo"
11241942|NCT02491788|BG002|Baseline|Total|Total of all reporting groups
11241943|NCT02491788|FG000|Participant Flow|Drug|"10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity~Suvorexant"
11241944|NCT02491788|FG001|Participant Flow|Placebo|"Placebo pill 30 minutes prior to daytime sleep opportunity~Placebo"
11241945|NCT02491788|OG000|Outcome|Drug|"10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity~Suvorexant"
11241946|NCT02491788|OG001|Outcome|Placebo|"Placebo pill 30 minutes prior to daytime sleep opportunity~Placebo"
11241947|NCT02491788|EG000|Reported Event|Drug|"10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity~Suvorexant"
11241948|NCT02491788|EG001|Reported Event|Placebo|"Placebo pill 30 minutes prior to daytime sleep opportunity~Placebo"
11241949|NCT02491892|BG000|Baseline|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
10800199|NCT02389374|EG001|Reported Event|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: single dose"
11241950|NCT02491892|BG001|Baseline|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11241951|NCT02491892|BG002|Baseline|Total|Total of all reporting groups
11241952|NCT02491892|FG000|Participant Flow|Pertuzumab 420 mg|Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11241953|NCT02491892|FG001|Participant Flow|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11241954|NCT02491892|OG000|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11241955|NCT02491892|OG001|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11241956|NCT02491892|EG000|Reported Event|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11198082|NCT02175966|OG001|Outcome|6 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198083|NCT02175966|EG000|Reported Event|4 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198084|NCT02175966|EG001|Reported Event|6 Weeks DCV 3DAA + SOF|Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
11198085|NCT02175979|BG000|Baseline|Standard|"standard of care~standard: standard of care"
11198086|NCT02175979|BG001|Baseline|Enriched Enteral Nutrition|"enriched enteral tube feeding 1.5ml/ minute perioperative~enriched enteral nutrition: enriched enteral tube feeding perioperative"
11198087|NCT02175979|BG002|Baseline|Total|Total of all reporting groups
11198088|NCT02175979|FG000|Participant Flow|Standard|standard of care
11198089|NCT02175979|FG001|Participant Flow|Enriched Enteral Nutrition|enriched enteral tube feeding 1.5ml/ minute perioperative
11198090|NCT02175979|OG000|Outcome|Standard|standard of care
11198091|NCT02175979|OG001|Outcome|Enriched Enteral Nutrition|enriched enteral tube feeding
11198092|NCT02175979|EG000|Reported Event|Standard|standard of care
11198093|NCT02175979|EG001|Reported Event|Enriched Enteral Nutrition|enriched enteral tube feeding
11198094|NCT02176005|BG000|Baseline|Moxifloxacin|Moxifloxacin (400mg x1/day taken orally for 5 days) used alone
11198095|NCT02176005|BG001|Baseline|DAV132 + Moxifloxacin|DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)
11198096|NCT02176005|BG002|Baseline|DAV132|DAV132 (7.5g x3/day taken orally for 7 days) used alone
11198097|NCT02176005|BG003|Baseline|Negative Control|Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)
11198098|NCT02176005|BG004|Baseline|Total|Total of all reporting groups
11198099|NCT02176005|FG000|Participant Flow|Moxifloxacin|Moxifloxacin (oral tablets, 400mg x1/day for 5 days) used alone
11198100|NCT02176005|FG001|Participant Flow|DAV132 + Moxifloxacin|DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)
11198101|NCT02176005|FG002|Participant Flow|DAV132|DAV132 (7.5g x3/day taken orally for 7 days) used alone
11198102|NCT02176005|FG003|Participant Flow|Negative Control|Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)
11198103|NCT02176005|OG000|Outcome|Moxifloxacin|"Moxifloxacin, oral tablets, 400mg/day, once daily 5 days~Moxifloxacin: Moxifloxacin is used alone or associated to DAV132"
11198104|NCT02176005|OG001|Outcome|Moxifloxacin + DAV132|"Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days~DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone~Moxifloxacin: Moxifloxacin is used alone or associated to DAV132"
10965938|NCT00884741|FG002|Participant Flow|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
11198105|NCT02176005|OG002|Outcome|DAV132|"DAV132 oral, 7.5g x3/day for 7 days~DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone"
11198106|NCT02176005|OG003|Outcome|Negative Control|"Negative control: 7.5g x3/day for 7 days~Negative Control: Moxifloxacin is used alone"
11198107|NCT02176005|EG000|Reported Event|Moxifloxacin|Moxifloxacin (400mg x1/day taken orally for 5 days) used alone
11198108|NCT02176005|EG001|Reported Event|Moxifloxacin + DAV132|DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)
11198109|NCT02176005|EG002|Reported Event|DAV132|DAV132 (7.5g x3/day taken orally for 7 days) used alone
11198110|NCT02176005|EG003|Reported Event|Negative Control|Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)
11198111|NCT02176018|BG000|Baseline|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
11198112|NCT02176018|BG001|Baseline|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
11198113|NCT02176018|BG002|Baseline|Total|Total of all reporting groups
11198114|NCT02176018|FG000|Participant Flow|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
11198115|NCT02176018|FG001|Participant Flow|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
11198116|NCT02176018|OG000|Outcome|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
11198117|NCT02176018|OG001|Outcome|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
11198118|NCT02176018|EG000|Reported Event|Nuedexta|"One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Dextromethorphan and quinidine"
11198119|NCT02176018|EG001|Reported Event|Placebo|"One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.~Placebo"
10800200|NCT02389374|EG002|Reported Event|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines~Artemether-lumefantrine combination: standard dose~Primaquine: 14 days"
11198120|NCT02176031|BG000|Baseline|Natalizumab|"Natalizumab-~(Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion~At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab.~If participants have no response after one dose, they will be not be given a second dose.~Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered.~Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365.~Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert"
11198121|NCT02176031|FG000|Participant Flow|Natalizumab|"Natalizumab-~(Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion~At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab.~If participants have no response after one dose, they will be not be given a second dose.~Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered.~Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365.~Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert"
11198122|NCT02176031|OG000|Outcome|Natalizumab|"Natalizumab-~(Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion~At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab.~If participants have no response after one dose, they will be not be given a second dose.~Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered.~Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365.~Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert."
11198123|NCT02176031|OG000|Outcome|Natalizumab|"Natalizumab-~(Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion~At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab.~If participants have no response after one dose, they will be not be given a second dose.~Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered.~Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365.~Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert~Natalizumab~Methylprednisolone"
11198124|NCT02176031|EG000|Reported Event|Natalizumab|"Natalizumab-~(Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion~At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab.~If participants have no response after one dose, they will be not be given a second dose.~Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered.~Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365.~Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert."
11198125|NCT02176083|BG000|Baseline|Intervention|"Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness~Text message management prompts"
11198126|NCT02176083|BG001|Baseline|Control|Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
11198127|NCT02176083|BG002|Baseline|Total|Total of all reporting groups
11198128|NCT02176083|FG000|Participant Flow|Intervention|"Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness~Text message management prompts"
11198129|NCT02176083|FG001|Participant Flow|Control|Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
11198130|NCT02176083|OG000|Outcome|Intervention|"Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness~Text message management prompts"
11198131|NCT02176083|OG001|Outcome|Control|Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
11198132|NCT02176083|EG000|Reported Event|Intervention|"Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness~Text message management prompts"
11198133|NCT02176083|EG001|Reported Event|Control|Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
11198134|NCT02176226|BG000|Baseline|8-Week Single Arm Field Trial|"Use of IntelliCare program for 8 weeks.~IntelliCare: Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare."
11198135|NCT02176226|FG000|Participant Flow|8-Week Single Arm Field Trial|"Use of IntelliCare program for 8 weeks.~IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare."
11198136|NCT02176226|OG000|Outcome|8-Week Single Arm Field Trial|"Use of IntelliCare program for 8 weeks.~IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare."
11198137|NCT02176226|EG000|Reported Event|8-Week Single Arm Field Trial|"Use of IntelliCare program for 8 weeks.~IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare."
11198138|NCT02176291|BG000|Baseline|Buprenorphine|"Buprenorphine~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)"
11198139|NCT02176291|BG001|Baseline|Placebo|"Placebo~Placebo: matched placebo"
11198140|NCT02176291|BG002|Baseline|Total|Total of all reporting groups
11198141|NCT02176291|FG000|Participant Flow|Buprenorphine|"Buprenorphine~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)"
11198142|NCT02176291|FG001|Participant Flow|Placebo|"Placebo~Placebo: matched placebo"
11198143|NCT02176291|OG000|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)
11198144|NCT02176291|OG001|Outcome|Placebo|Placebo: matched placebo
11241957|NCT02491892|EG001|Reported Event|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11241958|NCT02491944|BG000|Baseline|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11241959|NCT02491944|FG000|Participant Flow|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11241960|NCT02491944|OG000|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11241961|NCT02491944|EG000|Reported Event|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11241962|NCT02492100|BG000|Baseline|Multi-modality Sexual Dysfunction Intervention|"- Patients in remission > 6 months after allogeneic bone marrow transplant~Patient Enrollment and Baseline Data Collection~First Intervention Visit:~Comprehensive assessment of sexual dysfunction~Normalization & Education~Therapeutic interventions~Referral to Sexual Health Clinic if applicable~Follow-Up Intervention Visit --- Referral to Sexual Health Clinic if applicable~Multi-modality sexual dysfunction intervention"
11241963|NCT02492100|FG000|Participant Flow|Single Arm Pre and Post Sexual Health Intervention|A total of 47 patients who screened positive for sexual dysfunction causing distress agreed to participate in this pre-/post- design single-arm study
11241964|NCT02492100|OG000|Outcome|Single Arm Study|single arm study, pre/post design
11241965|NCT02492100|OG000|Outcome|Singe Arm Pre/Post Design|single arm pre/post design
11241966|NCT02492100|EG000|Reported Event|Single Arm Study|single arm study, pre/post design
11241967|NCT02492451|BG000|Baseline|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
11241968|NCT02492451|BG001|Baseline|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
11241969|NCT02492451|BG002|Baseline|Control Group|Only intrauterine insemination
10800201|NCT02386839|BG000|Baseline|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784).
11241970|NCT02492451|BG003|Baseline|Total|Total of all reporting groups
11241971|NCT02492451|FG000|Participant Flow|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
11241972|NCT02492451|FG001|Participant Flow|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
11241973|NCT02492451|FG002|Participant Flow|Control Group|Only intrauterine insemination
10800202|NCT02386839|BG001|Baseline|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784).
10800203|NCT02386839|BG002|Baseline|Total|Total of all reporting groups
11241974|NCT02492451|OG000|Outcome|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
11241975|NCT02492451|OG001|Outcome|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
11241976|NCT02492451|OG002|Outcome|Control Group|Only intrauterine insemination
11241977|NCT02492451|EG000|Reported Event|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
11241978|NCT02492451|EG001|Reported Event|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
11241979|NCT02492451|EG002|Reported Event|Control Group|Only intrauterine insemination
11241980|NCT02492750|BG000|Baseline|Phase I - Dose Level 1|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
10965939|NCT00884741|FG003|Participant Flow|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
11198145|NCT02176291|EG000|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)
10965940|NCT00884741|OG000|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
11198146|NCT02176291|EG001|Reported Event|Placebo|Placebo: matched placebo
11198147|NCT02176343|BG000|Baseline|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
11198148|NCT02176343|FG000|Participant Flow|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
11198149|NCT02176343|OG000|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
11198150|NCT02176343|EG000|Reported Event|ReSTOR Toric +2.5|All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
11198151|NCT02176356|BG000|Baseline|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
11198152|NCT02176356|FG000|Participant Flow|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
11198153|NCT02176356|OG000|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
11198154|NCT02176356|EG000|Reported Event|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
11198155|NCT02176382|BG000|Baseline|Standard Dose Teriparatide|"teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198156|NCT02176382|BG001|Baseline|High Dose Teriparatide|"teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198157|NCT02176382|BG002|Baseline|Total|Total of all reporting groups
11198158|NCT02176382|FG000|Participant Flow|Standard Dose Teriparatide|"teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198159|NCT02176382|FG001|Participant Flow|High Dose Teriparatide|"teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198160|NCT02176382|OG000|Outcome|Standard Dose Teriparatide|"teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198161|NCT02176382|OG001|Outcome|High Dose Teriparatide|"teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198162|NCT02176382|EG000|Reported Event|Standard Dose Teriparatide|"teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198163|NCT02176382|EG001|Reported Event|High Dose Teriparatide|"teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15~denosumab: denosumab subcutaneous injection~teriparatide: teriparatide daily subcutaneous injection~Zoledronic acid: zoledronic acid infusion"
11198164|NCT02176408|BG000|Baseline|Behavioral Activation Plus Exercise|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week's progress."
11198165|NCT02176408|BG001|Baseline|Behavioral Activation Plus Stretching|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week's progress."
11198166|NCT02176408|BG002|Baseline|Total|Total of all reporting groups
11198167|NCT02176408|FG000|Participant Flow|Behavioral Activation Plus Exercise|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week's progress."
10800204|NCT02386839|FG000|Participant Flow|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784).
10800205|NCT02386839|FG001|Participant Flow|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784).
10800206|NCT02386839|OG000|Outcome|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784).
10800207|NCT02386839|OG001|Outcome|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784).
11241981|NCT02492750|BG001|Baseline|Phase I - Dose Level 2|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
10800208|NCT02386839|OG000|Outcome|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784)
10800209|NCT02386839|OG001|Outcome|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784) .
10800210|NCT02386839|OG000|Outcome|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.
10965941|NCT00884741|OG001|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
11241982|NCT02492750|BG002|Baseline|Phase I - Dose Level 3|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11198168|NCT02176408|FG001|Participant Flow|Behavioral Activation Plus Stretching|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week's progress."
11198169|NCT02176408|OG000|Outcome|Behavioral Activation Plus Exercise|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week's progress."
11198170|NCT02176408|OG001|Outcome|Behavioral Activation Plus Stretching|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week's progress."
11198171|NCT02176408|EG000|Reported Event|Behavioral Activation Plus Exercise|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week's progress."
11198172|NCT02176408|EG001|Reported Event|Behavioral Activation Plus Stretching|"Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment~Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)~Behavioral Activation Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.~Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week's progress."
11198173|NCT02176421|BG000|Baseline|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
11198174|NCT02176421|FG000|Participant Flow|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
11198175|NCT02176421|OG000|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
11198176|NCT02176421|EG000|Reported Event|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
11198177|NCT02176486|BG000|Baseline|Pooled Placebo|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198178|NCT02176486|BG001|Baseline|Cohort A: Ixazomib 0.5 mg|Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198179|NCT02176486|BG002|Baseline|Cohort B: Ixazomib 2 mg|Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198180|NCT02176486|BG003|Baseline|Total|Total of all reporting groups
11198181|NCT02176486|FG000|Participant Flow|Pooled Placebo|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198182|NCT02176486|FG001|Participant Flow|Cohort A: Ixazomib 0.5 mg|Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198183|NCT02176486|FG002|Participant Flow|Cohort B: Ixazomib 2 mg|Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198184|NCT02176486|OG000|Outcome|Pooled Placebo|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198185|NCT02176486|OG001|Outcome|Cohort A: Ixazomib 0.5 mg|Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198186|NCT02176486|OG002|Outcome|Cohort B: Ixazomib 2 mg|Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198187|NCT02176486|OG000|Outcome|Cohort A: Ixazomib 0.5 mg|Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198188|NCT02176486|OG001|Outcome|Cohort B: Ixazomib 2 mg|Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198189|NCT02176486|EG000|Reported Event|Pooled Placebo|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198190|NCT02176486|EG001|Reported Event|Cohort A: Ixazomib 0.5 mg|Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198191|NCT02176486|EG002|Reported Event|Cohort B: Ixazomib 2 mg|Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
11198192|NCT02176525|BG000|Baseline|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198193|NCT02176525|BG001|Baseline|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
10965942|NCT00884741|EG000|Reported Event|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
11241983|NCT02492750|BG003|Baseline|Total|Total of all reporting groups
11241984|NCT02492750|FG000|Participant Flow|Phase I - Dose Level 1|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241985|NCT02492750|FG001|Participant Flow|Phase I - Dose Level 2|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241986|NCT02492750|FG002|Participant Flow|Phase I - Dose Level 3|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241987|NCT02492750|OG000|Outcome|Phase I - Dose Level 1|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241988|NCT02492750|OG001|Outcome|Phase I - Dose Level 2|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241989|NCT02492750|OG002|Outcome|Phase I - Dose Level 3|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241990|NCT02492750|EG000|Reported Event|Phase I - Dose Level 1|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241991|NCT02492750|EG001|Reported Event|Phase I - Dose Level 2|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241992|NCT02492750|EG002|Reported Event|Phase I - Dose Level 3|Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
11241993|NCT02492763|BG000|Baseline|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
11241994|NCT02492763|BG001|Baseline|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
11241995|NCT02492763|BG002|Baseline|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
11241996|NCT02492763|BG003|Baseline|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
11241997|NCT02492763|BG004|Baseline|Total|Total of all reporting groups
11241998|NCT02492763|FG000|Participant Flow|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
11241999|NCT02492763|FG001|Participant Flow|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
11242000|NCT02492763|FG002|Participant Flow|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
11242001|NCT02492763|FG003|Participant Flow|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
11242002|NCT02492763|OG000|Outcome|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
11242003|NCT02492763|OG001|Outcome|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
11242004|NCT02492763|OG002|Outcome|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
10965943|NCT00884741|EG001|Reported Event|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
11242005|NCT02492763|OG003|Outcome|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
11242006|NCT02492763|EG000|Reported Event|MK-8521 180 μg|Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
11242007|NCT02492763|EG001|Reported Event|MK-8521 300 μg|Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
11242008|NCT02492763|EG002|Reported Event|Placebo|Participants receive matching double-blind placebo QD over 12 weeks.
11242009|NCT02492763|EG003|Reported Event|Liraglutide 1.8 mg|Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
11242010|NCT02492802|BG000|Baseline|Patients on Posaconazole|Patient characteristics and drug dosing information (oral and intravenous dosing, daily dose of posaconazole)
11242011|NCT02492802|FG000|Participant Flow|Patients on Posaconazole|Hematology patients receiving posaconazole for routine care.
11242012|NCT02492802|OG000|Outcome|Posaconazole|Patients who received posaconazole for routine care
11198194|NCT02176525|BG002|Baseline|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198195|NCT02176525|BG003|Baseline|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198196|NCT02176525|BG004|Baseline|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198197|NCT02176525|BG005|Baseline|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198198|NCT02176525|BG006|Baseline|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198199|NCT02176525|BG007|Baseline|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198200|NCT02176525|BG008|Baseline|Total|Total of all reporting groups
11242013|NCT02492802|EG000|Reported Event|Posaconazole|"Route of administration:~Oral (MDR tablet), intravenous (infusion) Daily dose (mg/kg body weight): 3.75 (3.4-4.9)"
10965944|NCT00884741|EG002|Reported Event|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
10965945|NCT00884754|BG000|Baseline|Rigid GlideScope Specific Stylet|
10965946|NCT00884754|BG001|Baseline|90º Curvature, Malleable Stylet|
10965947|NCT00884754|BG002|Baseline|Total|Total of all reporting groups
10965948|NCT00884754|FG000|Participant Flow|Rigid GlideScope Specific Stylet|
10965949|NCT00884754|FG001|Participant Flow|90º Curvature, Malleable Stylet|
10965950|NCT00884754|OG000|Outcome|Rigid GlideScope Specific Stylet|
10965951|NCT00884754|OG001|Outcome|90º Curvature, Malleable Stylet|
10965952|NCT00884754|EG000|Reported Event|Rigid GlideScope Specific Stylet|
10965953|NCT00884754|EG001|Reported Event|90º Curvature, Malleable Stylet|
11198201|NCT02176525|FG000|Participant Flow|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198202|NCT02176525|FG001|Participant Flow|DBV 100mg Fibrosis|Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198203|NCT02176525|FG002|Participant Flow|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198204|NCT02176525|FG003|Participant Flow|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198205|NCT02176525|FG004|Participant Flow|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
10800211|NCT02386839|OG001|Outcome|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.
11198206|NCT02176525|FG005|Participant Flow|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
10800212|NCT02386839|EG000|Reported Event|Antecedent Standard of Care|Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784).
10800213|NCT02386839|EG001|Reported Event|Antecedent rhIGF-1/rhIGFBP-3|Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784).
11198207|NCT02176525|FG006|Participant Flow|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198208|NCT02176525|FG007|Participant Flow|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
10800214|NCT02362503|BG000|Baseline|Randomized Cohort-Placebo|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
11198209|NCT02176525|OG000|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198210|NCT02176525|OG001|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198211|NCT02176525|OG002|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198212|NCT02176525|OG003|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198213|NCT02176525|OG004|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198214|NCT02176525|OG005|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198215|NCT02176525|OG006|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198216|NCT02176525|OG007|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198217|NCT02176525|OG000|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198218|NCT02176525|OG001|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198219|NCT02176525|OG002|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
10800215|NCT02362503|BG001|Baseline|Randomized Cohort-fostemsavir 600 mg BID|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
11242014|NCT02492841|BG000|Baseline|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
10800216|NCT02362503|BG002|Baseline|Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period|Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
10800217|NCT02362503|BG003|Baseline|Total|Total of all reporting groups
10800218|NCT02362503|FG000|Participant Flow|Randomized Cohort-Placebo|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
10800219|NCT02362503|FG001|Participant Flow|Randomized Cohort-fostemsavir 600 mg BID|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
10800220|NCT02362503|FG002|Participant Flow|Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period|Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
11198220|NCT02176525|OG003|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198221|NCT02176525|OG004|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198222|NCT02176525|OG005|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198223|NCT02176525|OG006|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198224|NCT02176525|OG003|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
11198225|NCT02176525|EG000|Reported Event|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198226|NCT02176525|EG001|Reported Event|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11242015|NCT02492841|BG001|Baseline|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
11242016|NCT02492841|BG002|Baseline|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
11242017|NCT02492841|BG003|Baseline|Total|Total of all reporting groups
11242018|NCT02492841|FG000|Participant Flow|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
11242019|NCT02492841|FG001|Participant Flow|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
11242020|NCT02492841|FG002|Participant Flow|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
11242021|NCT02492841|OG000|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate~Three failed up to 12 months follow up.~one endodontic~one pulpotomy~one pulp capping"
11242022|NCT02492841|OG001|Outcome|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.~Three failed up to 12 months follow up~two endodontic~one tooth extraction"
11242023|NCT02492841|OG002|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.~Cero failed up to 12 months follow up"
11242024|NCT02492841|OG000|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
11242025|NCT02492841|OG001|Outcome|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
11242026|NCT02492841|OG002|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
11242027|NCT02492841|EG000|Reported Event|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material~Mineral trioxide aggregate: Mineral trioxide aggregate"
11242028|NCT02492841|EG001|Reported Event|Calcium Hydroxide|"-material for pulp capping~Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
11242029|NCT02492841|EG002|Reported Event|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping~Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
11242030|NCT02492854|BG000|Baseline|Standard Sterile Gauze Dressings|"In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.~Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively."
11242031|NCT02492854|BG001|Baseline|PICO Negative Pressure Dressings|"In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.~PICO Single-Use Negative Pressure Dressings: Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved."
11242032|NCT02492854|BG002|Baseline|Total|Total of all reporting groups
11242033|NCT02492854|FG000|Participant Flow|Standard Sterile Gauze Dressings|"In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.~Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively."
11242034|NCT02492854|FG001|Participant Flow|PICO Negative Pressure Dressings|"In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.~PICO Single-Use Negative Pressure Dressings: Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of surgical-site infections (SSIs) post-lower extremity (LE) bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved."
11242035|NCT02492854|OG000|Outcome|Standard Sterile Gauze Dressings|"In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.~Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively."
10800221|NCT02362503|OG000|Outcome|Randomized Cohort-Placebo|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
11198227|NCT02176525|EG002|Reported Event|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198228|NCT02176525|EG003|Reported Event|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198229|NCT02176525|EG004|Reported Event|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198230|NCT02176525|EG005|Reported Event|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
11198231|NCT02176525|EG006|Reported Event|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198232|NCT02176525|EG007|Reported Event|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
11198233|NCT02176642|BG000|Baseline|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
11242036|NCT02492854|OG001|Outcome|PICO Negative Pressure Dressings|"In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.~PICO Single-Use Negative Pressure Dressings: Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved."
11242037|NCT02492854|EG000|Reported Event|Standard Sterile Gauze Dressings|"In this arm, pts. will be randomized to receive standard sterile gauze dressing post-operatively.~Sterile Gauze Dressings: Current standard-of-care dressings used to cover surgical wounds post-operatively."
11242038|NCT02492854|EG001|Reported Event|PICO Negative Pressure Dressings|"In this arm, pts. will be randomized to receive PICO single-use negative pressure dressings.~PICO Single-Use Negative Pressure Dressings: Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved."
11242039|NCT02492880|BG000|Baseline|Precision Spectra™ SCS System Programming Features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
11242040|NCT02492880|FG000|Participant Flow|Precision Spectra™ SCS System Programming Features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
11242041|NCT02492880|OG000|Outcome|Precision Spectra™ SCS System Programming Features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
11242042|NCT02492880|EG000|Reported Event|Precision Spectra™ SCS System Programming Features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
11242043|NCT02492958|BG000|Baseline|Placebo (20 to <65 Years)|Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242044|NCT02492958|BG001|Baseline|SA4Ag (20 to <65 Years)|Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242045|NCT02492958|BG002|Baseline|Placebo (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242046|NCT02492958|BG003|Baseline|SA4Ag (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242047|NCT02492958|BG004|Baseline|Total|Total of all reporting groups
11242048|NCT02492958|FG000|Participant Flow|Placebo (20 to <65 Years)|Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242049|NCT02492958|FG001|Participant Flow|SA4Ag (20 to <65 Years)|Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242050|NCT02492958|FG002|Participant Flow|Placebo (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242051|NCT02492958|FG003|Participant Flow|SA4Ag (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242052|NCT02492958|OG000|Outcome|Placebo (20 to <65 Years)|Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242053|NCT02492958|OG001|Outcome|SA4Ag (20 to <65 Years)|Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242054|NCT02492958|OG002|Outcome|Placebo (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242055|NCT02492958|OG003|Outcome|SA4Ag (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242056|NCT02492958|EG000|Reported Event|Placebo (20 to <65 Years)|Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242057|NCT02492958|EG001|Reported Event|SA4Ag (20 to <65 Years)|Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242058|NCT02492958|EG002|Reported Event|Placebo (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242059|NCT02492958|EG003|Reported Event|SA4Ag (65 to <86 Years)|Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
11242060|NCT02492984|BG000|Baseline|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
11242061|NCT02492984|BG001|Baseline|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242062|NCT02492984|BG002|Baseline|Total|Total of all reporting groups
11242063|NCT02492984|FG000|Participant Flow|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
11242064|NCT02492984|FG001|Participant Flow|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242065|NCT02492984|OG000|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
11242066|NCT02492984|OG001|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242067|NCT02492984|OG000|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242068|NCT02492984|OG000|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242069|NCT02492984|EG000|Reported Event|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
11242070|NCT02492984|EG001|Reported Event|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
11242071|NCT02492984|EG002|Reported Event|Total|Treatment Group Description TBD
11242072|NCT02492997|BG000|Baseline|Treatment Group|Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
11242073|NCT02492997|BG001|Baseline|Control Group|Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
11242074|NCT02492997|BG002|Baseline|Total|Total of all reporting groups
11242075|NCT02492997|FG000|Participant Flow|Treatment Group|"Group treated with the active Venus Versa octipolar applicator and the glycerin gel.~Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.~Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution"
11242076|NCT02492997|FG001|Participant Flow|Control Group|"Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.~Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.~Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution"
11242077|NCT02492997|OG000|Outcome|Treatment Group|Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
11242078|NCT02492997|OG001|Outcome|Control Group|Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
11242079|NCT02492997|EG000|Reported Event|Treatment Group|Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
11242080|NCT02492997|EG001|Reported Event|Control Group|Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
11242081|NCT02493036|BG000|Baseline|42-mg SYN-010/42-mg SYN-010|42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
11242082|NCT02493036|BG001|Baseline|21-mg SYN-010/42-mg SYN-010|21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
11242083|NCT02493036|BG002|Baseline|Placebo/42-mg SYN-010|Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study
11242084|NCT02493036|BG003|Baseline|Total|Total of all reporting groups
11242085|NCT02493036|FG000|Participant Flow|High Dose SYN-010|42-mg SYN-010
11242086|NCT02493036|FG001|Participant Flow|Low Dose SYN-010|21-mg SYN-010
11242087|NCT02493036|FG002|Participant Flow|Placebo|Placebo
11242088|NCT02493036|OG000|Outcome|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
11242089|NCT02493036|OG001|Outcome|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
10800222|NCT02362503|OG001|Outcome|Randomized Cohort-fostemsavir 600 mg BID|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
11242090|NCT02493036|OG002|Outcome|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
11198234|NCT02176642|BG001|Baseline|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
11198235|NCT02176642|BG002|Baseline|Total|Total of all reporting groups
11198236|NCT02176642|FG000|Participant Flow|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
11198237|NCT02176642|FG001|Participant Flow|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
11198238|NCT02176642|OG000|Outcome|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
11198239|NCT02176642|OG001|Outcome|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
11198240|NCT02176642|EG000|Reported Event|Oxybutynin Plus PTNS|"Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks"
11198241|NCT02176642|EG001|Reported Event|Placebo Plus PTNS|"Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.~Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks~Placebo: Tablet taken by mouth daily for 6 weeks"
11198242|NCT02176655|BG000|Baseline|Cross-Over Group|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
11198243|NCT02176655|FG000|Participant Flow|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
11198244|NCT02176655|OG000|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
11198245|NCT02176655|OG001|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
11198246|NCT02176655|EG000|Reported Event|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
11198247|NCT02176837|BG000|Baseline|Sodium Nitrite|64 nmol/min/kg sodium nitrite
11198248|NCT02176837|FG000|Participant Flow|Sodium Nitrite|64 nmol/min/kg sodium nitrite
11198249|NCT02176837|OG000|Outcome|Sodium Nitrite|64 nmol/min/kg sodium nitrite
11198250|NCT02176837|EG000|Reported Event|Sodium Nitrite|64 nmol/min/kg sodium nitrite
11198251|NCT02176928|BG000|Baseline|AutoPAP|"PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP: PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP treatment 7 nights a week for four months (16 weeks)."
11198252|NCT02176928|BG001|Baseline|Sham PAP|"Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.~Sham PAP: Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.~Sham PAP treatment 7 nights a week for four months (16 weeks)./"
11198253|NCT02176928|BG002|Baseline|Total|Total of all reporting groups
11198254|NCT02176928|FG000|Participant Flow|AutoPAP|"PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP: PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP treatment 7 nights a week for four months (16 weeks)."
11198255|NCT02176928|FG001|Participant Flow|Sham PAP|"Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.~Sham PAP: Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.~Sham PAP treatment 7 nights a week for four months (16 weeks)./"
11198256|NCT02176928|OG000|Outcome|AutoPAP|"PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP: PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP treatment 7 nights a week for four months (16 weeks)."
11198257|NCT02176928|OG001|Outcome|Sham PAP|"Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.~Sham PAP: Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.~Sham PAP treatment 7 nights a week for four months (16 weeks)./"
11198258|NCT02176928|EG000|Reported Event|AutoPAP|"PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP: PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP treatment 7 nights a week for four months (16 weeks)."
11198259|NCT02176928|EG001|Reported Event|Sham PAP|"Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.~Sham PAP: Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.~Sham PAP treatment 7 nights a week for four months (16 weeks)./"
11198260|NCT02177032|BG000|Baseline|4-sites, 1-week WITHOUT HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11242091|NCT02493036|EG000|Reported Event|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
11198261|NCT02177032|BG001|Baseline|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight"
11198262|NCT02177032|BG002|Baseline|2-sites, TRC WITHOUT HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen."
11198263|NCT02177032|BG003|Baseline|2-sites, TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly"
11198264|NCT02177032|BG004|Baseline|Total|Total of all reporting groups
11198265|NCT02177032|FG000|Participant Flow|4-sites, 1-week WITHOUT HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11198266|NCT02177032|FG001|Participant Flow|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly"
11198267|NCT02177032|FG002|Participant Flow|2-sites, TRC WITHOUT HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen"
11198268|NCT02177032|FG003|Participant Flow|2-sites, TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly"
11198269|NCT02177032|OG000|Outcome|TOTAL 4-sites, 1-week|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen with and without HRIG administered on day 1"
11198270|NCT02177032|OG001|Outcome|TOTAL 2-sites, TRC|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen, with or without HRIG administered on day 1"
11198271|NCT02177032|OG000|Outcome|TOTAL 4-sites, 1-week|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1"
11198272|NCT02177032|OG000|Outcome|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight"
11198273|NCT02177032|OG001|Outcome|4-sites, 1-week WITHOUT HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11198274|NCT02177032|OG000|Outcome|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight"
11198275|NCT02177032|OG000|Outcome|4-sites, 1-week Without HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11198276|NCT02177032|OG001|Outcome|2-sites, TRC Without HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen."
11198277|NCT02177032|OG000|Outcome|4-sites, 1-week WITHOUT HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11198278|NCT02177032|OG001|Outcome|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight"
11198279|NCT02177032|OG002|Outcome|2-sites, TRC WITHOUT HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen."
11198280|NCT02177032|OG003|Outcome|2-sites, TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly"
11198281|NCT02177032|OG002|Outcome|2-sites, TRC WITHOUT HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen"
11198282|NCT02177032|OG001|Outcome|2-sites TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen, with or without HRIG administered on day 1"
11198283|NCT02177032|OG001|Outcome|2-sites, TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen, with or without HRIG administered on day 1"
11198284|NCT02177032|EG000|Reported Event|4-sites, 1-week WITHOUT HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen"
11198285|NCT02177032|EG001|Reported Event|4-sites, 1-week WITH HRIG|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight"
11198286|NCT02177032|EG002|Reported Event|2-sites, TRC WITHOUT HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen."
11242092|NCT02493036|EG001|Reported Event|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
11198287|NCT02177032|EG003|Reported Event|2-sites, TRC WITH HRIG|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly"
11198288|NCT02177123|BG000|Baseline|Subjects Suffering From Primary Open Angle Glaucoma|Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery.
11198289|NCT02177123|FG000|Participant Flow|Subjects Suffering From Primary Open Angle Glaucoma|Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
11198290|NCT02177123|OG000|Outcome|Success With Respect for IOP|The rates of success reflected sustained control of IOP
11198291|NCT02177123|OG000|Outcome|IOP Changes From Baseline|IOP Changes from Baseline thur all timepoints
11198292|NCT02177123|OG000|Outcome|Need for Glaucoma Supplemental Treatment at M12|Patients Taking Glaucoma Supplemental Treatment (Study Eye)
11198293|NCT02177123|OG001|Outcome|Need for Glaucoma Supplemental Treatment at M24|Patients Taking Glaucoma Supplemental Treatment (Study Eye)
11198294|NCT02177123|EG000|Reported Event|Subjects Suffering From Primary Open Angle Glaucoma|Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
11198295|NCT02177136|BG000|Baseline|1.5 mg OCA Titrating to 3 mg OCA|Participants randomized to 1.5 mg OCA took 1.5 mg OCA daily for 12 weeks. If tolerated, the dose was increased to 3 mg OCA daily for an additional 12 weeks.
11198296|NCT02177136|BG001|Baseline|5 mg OCA Titrating to 10 mg OCA|Participants randomized to 5 mg OCA took 5 mg OCA daily for 12 weeks. If tolerated, the dose was increased to 10 mg OCA daily for an additional 12 weeks.
11198297|NCT02177136|BG002|Baseline|Placebo|Participants randomized to placebo took placebo for 24 weeks.
11198298|NCT02177136|BG003|Baseline|Total|Total of all reporting groups
11198299|NCT02177136|FG000|Participant Flow|1.5 mg OCA Titrating to 3 mg OCA|Participants randomized to 1.5 mg OCA took 1.5 mg OCA daily for 12 weeks during the DB phase. If tolerated, the dose was increased to 3 mg OCA daily for an additional 12 weeks.
11198300|NCT02177136|FG001|Participant Flow|5 mg OCA Titrating to 10 mg OCA|Participants randomized to 5 mg OCA took 5 mg OCA daily for 12 weeks during the DB phase. If tolerated, the dose was increased to 10 mg OCA daily for an additional 12 weeks.
11198301|NCT02177136|FG002|Participant Flow|Placebo|Participants randomized to placebo took placebo daily for 24 weeks during the DB phase.
11198302|NCT02177136|FG003|Participant Flow|LTSE OCA Total|Following completion of the DB phase, participants were asked to reconfirm their consent for participation in the LTSE phase (planned as a further 24 months) beginning at 5 or 10 mg OCA, based on the last treatment received during the DB phase. Doses up to 10 mg daily were evaluated. All participants received open-label OCA during the LTSE phase of the study.
11198303|NCT02177136|OG000|Outcome|1.5 mg OCA Titrating to 3 mg OCA|Participants randomized to 1.5 mg OCA took 1.5 mg OCA daily for 12 weeks. If tolerated, the dose was increased to 3 mg OCA daily for an additional 12 weeks.
11198304|NCT02177136|OG001|Outcome|5 mg OCA Titrating to 10 mg OCA|Participants randomized to 5 mg OCA took 5 mg OCA daily for 12 weeks. If tolerated, the dose was increased to 10 mg OCA daily for an additional 12 weeks.
11198305|NCT02177136|OG002|Outcome|Placebo|Participants randomized to placebo took placebo daily for 24 weeks.
11198306|NCT02177136|OG000|Outcome|LTSE OCA Total|Following completion of the DB phase, participants were asked to reconfirm their consent for participation in the LTSE phase (planned as a further 24 months) beginning at 5 or 10 mg OCA, based on the last treatment received during the DB phase. Doses up to 10 mg daily were evaluated. All participants received open-label OCA during the LTSE phase of the study.
11198307|NCT02177136|OG002|Outcome|Placebo|Participants randomized to placebo took placebo for 24 weeks.
11198308|NCT02177136|EG000|Reported Event|1.5 mg OCA Titrating to 3 mg OCA|Participants randomized to 1.5 mg OCA took 1.5 mg OCA daily for 12 weeks during the DB phase. If tolerated, the dose was increased to 3 mg OCA daily for an additional 12 weeks.
11198309|NCT02177136|EG001|Reported Event|5 mg OCA Titrating to 10 mg OCA|Participants randomized to 5 mg OCA took 5 mg OCA daily for 12 weeks during the DB phase. If tolerated, the dose was increased to 10 mg OCA daily for an additional 12 weeks.
11198310|NCT02177136|EG002|Reported Event|Placebo|Participants randomized to placebo took placebo daily for 24 weeks during the DB phase.
11198311|NCT02177136|EG003|Reported Event|LTSE OCA Total|Following completion of the DB phase, participants were asked to reconfirm their consent for participation in the LTSE phase (planned as a further 24 months) beginning at 5 or 10 mg OCA, based on the last treatment received during the DB phase. Doses up to 10 mg daily were evaluated. All participants received open-label OCA during the LTSE phase of the study.
11198312|NCT02177201|BG000|Baseline|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
11198313|NCT02177201|BG001|Baseline|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
11198314|NCT02177201|BG002|Baseline|Total|Total of all reporting groups
11198315|NCT02177201|FG000|Participant Flow|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
11198316|NCT02177201|FG001|Participant Flow|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
11198317|NCT02177201|OG000|Outcome|10 ml/kg/h 0.9 %Saline Solution|"Group 1, intravenous 10 ml/kg/h 0.9% saline solution ,~0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;"
11198318|NCT02177201|OG001|Outcome|20 ml/kg/h 0.9% Saline Solution|"Group 2, intravenous 20 ml/kg/h 0.9% saline solution~0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively"
11242093|NCT02493036|EG002|Reported Event|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
11242094|NCT02493062|BG000|Baseline|Single-arm Study|"This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery.~Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies."
11198319|NCT02177201|EG000|Reported Event|Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution|Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
11198320|NCT02177201|EG001|Reported Event|Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution|Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
11198321|NCT02177786|BG000|Baseline|Selonsertib 2 mg|Selonsertib 2 mg tablet once daily for 48 weeks
11198322|NCT02177786|BG001|Baseline|Selonsertib 6 mg|Selonsertib 6 mg tablet once daily for 48 weeks
11198323|NCT02177786|BG002|Baseline|Selonsertib 18 mg|Selonsertib 18 mg tablet once daily for 48 weeks
11198324|NCT02177786|BG003|Baseline|Placebo|Placebo tablet once daily for 48 weeks
11198325|NCT02177786|BG004|Baseline|Total|Total of all reporting groups
11198326|NCT02177786|FG000|Participant Flow|Selonsertib 2 mg|Selonsertib 2 mg tablet once daily for 48 weeks
11198327|NCT02177786|FG001|Participant Flow|Selonsertib 6 mg|Selonsertib 6 mg tablet once daily for 48 weeks
11198328|NCT02177786|FG002|Participant Flow|Selonsertib 18 mg|Selonsertib 18 mg tablet once daily for 48 weeks
11198329|NCT02177786|FG003|Participant Flow|Placebo|Placebo tablet once daily for 48 weeks
11198330|NCT02177786|OG000|Outcome|Selonsertib 2 mg|Selonsertib 2 mg tablet once daily for 48 weeks
11198331|NCT02177786|OG001|Outcome|Selonsertib 6 mg|Selonsertib 6 mg tablet once daily for 48 weeks
11198332|NCT02177786|OG002|Outcome|Selonsertib 18 mg|Selonsertib 18 mg tablet once daily for 48 weeks
11198333|NCT02177786|OG003|Outcome|Placebo|Placebo tablet once daily for 48 weeks
11198334|NCT02177786|EG000|Reported Event|Selonsertib 2 mg|Selonsertib 2 mg tablet once daily for 48 weeks
11198335|NCT02177786|EG001|Reported Event|Selonsertib 6 mg|Selonsertib 6 mg tablet once daily for 48 weeks
11198336|NCT02177786|EG002|Reported Event|Selonsertib 18 mg|Selonsertib 18 mg tablet once daily for 48 weeks
11198337|NCT02177786|EG003|Reported Event|Placebo|Placebo tablet once daily for 48 weeks
11198338|NCT02177812|BG000|Baseline|Part 1:GSK2879552 1mg QD|Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.
11198339|NCT02177812|BG001|Baseline|Part 1: GSK2879552 2mg QD|Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.
11198340|NCT02177812|BG002|Baseline|Part 1: GSK2879552 4mg QD|Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.
11198341|NCT02177812|BG003|Baseline|Part 1: GSK2879552 8mg QD|Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.
11198342|NCT02177812|BG004|Baseline|Part 1: GSK2879552 12mg QD|Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.
11198343|NCT02177812|BG005|Baseline|Part 1: GSK2879552 20mg QD|Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.
11198344|NCT02177812|BG006|Baseline|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m^2/day.
11198345|NCT02177812|BG007|Baseline|Part 1: GSK2879552 20mg QD PK/PD Expansion|Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
11198346|NCT02177812|BG008|Baseline|Part 2: Expansion Cohort|In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.
11198347|NCT02177812|BG009|Baseline|Total|Total of all reporting groups
11198348|NCT02177812|FG000|Participant Flow|Part 1:GSK2879552 1mg QD|Participants received GSK2879552 1 milligram (mg) orally once daily (QD) in fasted condition with approximately 200 milliliter (mL) of water
11198349|NCT02177812|FG001|Participant Flow|Part 1: GSK2879552 2mg QD|Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water
11198350|NCT02177812|FG002|Participant Flow|Part 1: GSK2879552 4mg QD|Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.
11198351|NCT02177812|FG003|Participant Flow|Part 1: GSK2879552 8mg QD|Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water
11198352|NCT02177812|FG004|Participant Flow|Part 1: GSK2879552 12mg QD|Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.
11198353|NCT02177812|FG005|Participant Flow|Part 1: GSK2879552 20mg QD|Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.
11198354|NCT02177812|FG006|Participant Flow|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with All-Trans Retinoic Acid (ATRA) at a dose of 45 mg per meter square per day (mg/m^2/day).
11198355|NCT02177812|FG007|Participant Flow|Part 1: GSK2879552 20mg QD PK/PD Expansion|Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in Pharmacokinetic/Pharmacodynamics (PK/PD) Expansion cohort to collect adequate data on safety, PK or PD.
11198356|NCT02177812|FG008|Participant Flow|Part 2: Expansion Cohort|In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA
11198357|NCT02177812|OG000|Outcome|Part 1:GSK2879552 1mg QD|Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.
11198358|NCT02177812|OG001|Outcome|Part 1: GSK2879552 2mg QD|Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.
11198359|NCT02177812|OG002|Outcome|Part 1: GSK2879552 4mg QD|Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.
11198360|NCT02177812|OG003|Outcome|Part 1: GSK2879552 8mg QD|Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.
11198361|NCT02177812|OG004|Outcome|Part 1: GSK2879552 12mg QD|Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.
11198362|NCT02177812|OG005|Outcome|Part 1: GSK2879552 20mg QD|Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.
11198363|NCT02177812|OG006|Outcome|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m^2/day.
11198364|NCT02177812|OG007|Outcome|Part 1: GSK2879552 20mg QD PK/PD Expansion|Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
10800223|NCT02362503|OG000|Outcome|Randomized Cohort|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
11198365|NCT02177812|OG000|Outcome|Part 2: Expansion Cohort|In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.
11198366|NCT02177812|OG000|Outcome|Part 1: GSK2879552 2mg QD|Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.
11198367|NCT02177812|OG001|Outcome|Part 1: GSK2879552 4mg QD|Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.
11198368|NCT02177812|OG002|Outcome|Part 1: GSK2879552 8mg QD|Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.
11198369|NCT02177812|OG003|Outcome|Part 1: GSK2879552 12mg QD|Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.
11198370|NCT02177812|OG004|Outcome|Part 1: GSK2879552 20mg QD|Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.
11198371|NCT02177812|OG005|Outcome|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m^2/day.
11198372|NCT02177812|OG006|Outcome|Part 1: GSK2879552 20mg QD PK/PD Expansion|Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
11198373|NCT02177812|OG000|Outcome|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m^2/day.
11198374|NCT02177812|OG000|Outcome|Part 2: Expansion Cohort|All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.
11198375|NCT02177812|EG000|Reported Event|Part 1:GSK2879552 1mg QD|Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.
11198376|NCT02177812|EG001|Reported Event|Part 1: GSK2879552 2mg QD|Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.
11198377|NCT02177812|EG002|Reported Event|Part 1: GSK2879552 4mg QD|Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.
11198378|NCT02177812|EG003|Reported Event|Part 1: GSK2879552 8mg QD|Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.
11198379|NCT02177812|EG004|Reported Event|Part 1: GSK2879552 12mg QD|Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.
11198380|NCT02177812|EG005|Reported Event|Part 1: GSK2879552 20mg QD|Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.
11198381|NCT02177812|EG006|Reported Event|Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day|Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m^2/day.
11198382|NCT02177812|EG007|Reported Event|Part 1: GSK2879552 20mg QD PK/PD Expansion|Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
11198383|NCT02177812|EG008|Reported Event|Part 2: Expansion Cohort|In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.
11198384|NCT02177838|BG000|Baseline|Treatment (Cetuximab, Cisplatin, EBRT)|"Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.~cetuximab: Given IV~cisplatin: Given IV~external beam radiation therapy: Undergo EBRT~laboratory biomarker analysis: Correlative studies"
11198385|NCT02177838|FG000|Participant Flow|Treatment (Cetuximab, Cisplatin, EBRT)|"Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.~cetuximab: Given IV~cisplatin: Given IV~external beam radiation therapy: Undergo EBRT~laboratory biomarker analysis: Correlative studies"
10800224|NCT02362503|OG000|Outcome|Randomized Cohort|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks
11198386|NCT02177838|OG000|Outcome|Treatment (Cetuximab, Cisplatin, EBRT)|"Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.~cetuximab: Given IV~cisplatin: Given IV~external beam radiation therapy: Undergo EBRT~laboratory biomarker analysis: Correlative studies"
11198387|NCT02177838|EG000|Reported Event|Treatment (Cetuximab, Cisplatin, EBRT)|"Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.~cetuximab: Given IV~cisplatin: Given IV~external beam radiation therapy: Undergo EBRT~laboratory biomarker analysis: Correlative studies"
11198388|NCT02177942|BG000|Baseline|Test|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198389|NCT02177942|BG001|Baseline|Control|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198390|NCT02177942|BG002|Baseline|Total|Total of all reporting groups
11198391|NCT02177942|FG000|Participant Flow|Test|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mililiters (mL) drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198392|NCT02177942|FG001|Participant Flow|Control|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198393|NCT02177942|OG000|Outcome|Test|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198394|NCT02177942|OG001|Outcome|Control|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198395|NCT02177942|OG000|Outcome|Test|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday
11198396|NCT02177942|OG001|Outcome|Control|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday
11198397|NCT02177942|OG000|Outcome|Test Beverage Powder|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198398|NCT02177942|OG001|Outcome|Control Beverage Powder|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198399|NCT02177942|EG000|Reported Event|Test|30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198400|NCT02177942|EG001|Reported Event|Control|30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
11198401|NCT02178059|BG000|Baseline|Randomized Subjects|All randomized subjects
11198402|NCT02178059|FG000|Participant Flow|M3 First, Then M2|Sequence 1: M3 first then M2
11198403|NCT02178059|FG001|Participant Flow|M2 First, Then M3|Sequence 2: M2 first, then M3
11198404|NCT02178059|OG000|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
11198405|NCT02178059|OG001|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
11198406|NCT02178059|EG000|Reported Event|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
11198407|NCT02178059|EG001|Reported Event|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
11198408|NCT02178241|BG000|Baseline|Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)|"Patients receive 1000mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Gemcitabine Hydrochloride: Given IV"
11198409|NCT02178241|FG000|Participant Flow|Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)|"Patients receive 1000mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Gemcitabine Hydrochloride: Given IV"
11198410|NCT02178241|OG000|Outcome|Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)|"Patients receive 1000mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Gemcitabine Hydrochloride: Given IV"
11198411|NCT02178241|EG000|Reported Event|Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)|"Patients receive 1000mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Eribulin Mesylate: Given IV~Gemcitabine Hydrochloride: Given IV"
11198412|NCT02178475|BG000|Baseline|Chemotherapy + Pegfilgrastim|Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
11198413|NCT02178475|FG000|Participant Flow|Chemotherapy + Pegfilgrastim|Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
11198414|NCT02178475|OG000|Outcome|Chemotherapy + Pegfilgrastim|Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
11198415|NCT02178475|EG000|Reported Event|Chemotherapy + Pegfilgrastim|Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
11198416|NCT02178540|BG000|Baseline|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
11198417|NCT02178540|FG000|Participant Flow|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
11198418|NCT02178540|OG000|Outcome|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
11198419|NCT02178540|EG000|Reported Event|Open Label (6-10) Years Old|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
11198420|NCT02178540|EG001|Reported Event|Total - All Participants|
11198421|NCT02178540|EG002|Reported Event|Open Label (11-17)Years Old|
11198422|NCT02178540|EG003|Reported Event|Open Label (>=18) Years Old|
11198423|NCT02178553|BG000|Baseline|Epidural|In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.
11198424|NCT02178553|BG001|Baseline|Intercostal Bupivicaine (Exparel)|In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
11198425|NCT02178553|BG002|Baseline|Total|Total of all reporting groups
11242095|NCT02493062|FG000|Participant Flow|Single-arm Study|"This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery.~Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies."
11242096|NCT02493062|OG000|Outcome|Single-arm Study|"This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery.~Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies."
11198426|NCT02178553|FG000|Participant Flow|Epidural|In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.
11198427|NCT02178553|FG001|Participant Flow|Intercostal Bupivicaine (Exparel)|In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
11198428|NCT02178553|OG000|Outcome|Epidural|In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.
11198429|NCT02178553|OG001|Outcome|Intercostal Bupivicaine (Exparel)|In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
11198430|NCT02178553|EG000|Reported Event|Epidural|"In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.~Epidural"
11198431|NCT02178553|EG001|Reported Event|Intercostal Bupivicaine (Exparel)|"In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.~Intercostal Bupivicaine (Exparel)"
11198432|NCT02178592|BG000|Baseline|DTG 50 mg|Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).
11198433|NCT02178592|BG001|Baseline|EFV 600 mg|Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
11198434|NCT02178592|BG002|Baseline|Total|Total of all reporting groups
11198435|NCT02178592|FG000|Participant Flow|DTG 50 mg|Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).
11198436|NCT02178592|FG001|Participant Flow|EFV 600 mg|Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
11242097|NCT02493062|EG000|Reported Event|Single-arm Study|"This single-arm study is described by women who have undergone prenatal fetal open (uterus was opened to perform a fetal intervention/surgery) surgery and cesarean section delivery.~Sonohysterogram: The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies."
11198437|NCT02178592|OG000|Outcome|DTG 50 mg|Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).
11198438|NCT02178592|OG000|Outcome|EFV 600 mg|Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
11198439|NCT02178592|OG001|Outcome|EFV 600 mg|Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
11198440|NCT02178592|EG000|Reported Event|DTG 50 mg- Randomized Phase|In randomized phase, participants received DTG 50 mg tablet with or without food twice-daily with 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through 52 weeks.
11198441|NCT02178592|EG001|Reported Event|EFV 600 mg- Randomized Phase|In randomized phase, participants received EFV 600 mg tablet administered without food plus 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions through 52 weeks.
11198442|NCT02178592|EG002|Reported Event|DTG 50 mg- OLE Phase|In OLE Phase, participants received DTG 50 mg tablet until DTG became locally approved and commercially available.
11198443|NCT02178592|EG003|Reported Event|EFV 600 mg- OLE Phase|In OLE Phase, participants received EFV 600 mg tablet.
11198444|NCT02178696|BG000|Baseline|Total Study Population|
11198445|NCT02178696|FG000|Participant Flow|Known Placebo First|"This arm gets a placebo that they know is a placebo (called inactive), then has 2 scans performed (FMRI and PET), then a 2-3 day washout, and then gets a so-called active medication (which is also actually a placebo), and another pair of scans. Following these, participants receive 10 weeks of open-label antidepressant administration (Celexa or alternative as explained in intervention description). First line antidepressant will be Celexa unless not clinically indicated.~Placebo, identified as placebo to participants: White tablets~Celexa or other antidepressant as clinically indicated: Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg~Placebo, identifed to participants as Active medication: Blue Capsule"
11242098|NCT02493088|BG000|Baseline|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
11198446|NCT02178696|FG001|Participant Flow|"Active (Blinded) Placebo First Group"|"This arm gets a placebo that they don't know is a placebo (called Active), then has 2 scans performed (FMRI and PET), then a 2-3 day washout, and then gets a so-called inactive medication (which participants know is a placebo), and another pair of scans. Following these, participants receive 10 weeks of open-label antidepressant administration (Celexa as explained in intervention description). First line antidepressant will be Celexa unless not clinically indicated.~Placebo, identified as placebo to participants: White tablets~Celexa or other antidepressant as clinically indicated: Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg~Placebo, identifed to participants as Active medication: Blue Capsule"
11198447|NCT02178696|OG000|Outcome|Changes in Mu-opioid Binding (Inactive -Active Placebo)|Average regional changes in mu-opioid binding potential from the Inactive to the Active Placebo Condition.
11198448|NCT02178696|OG000|Outcome|Changes in BOLD Responses During the MID After Placebo|Changes in BOLD response from the Inactive to the Active condition during the Monetary Incentive Delayed Task in the Nucleus Accumbens.
11198449|NCT02178696|OG000|Outcome|Average Regional Changes in D2/3 Binding (Inactive-Active Plac|Average regional changes in D2/3 binding potential from the Inactive to the Active placebo condition.
11198450|NCT02178696|OG000|Outcome|Active Placebo|
11198451|NCT02178696|OG001|Outcome|Inactive Placebo|
11198452|NCT02178696|OG000|Outcome|Open-label Antidepressant Treatment After Placebo Experiment|
11198453|NCT02178696|OG000|Outcome|MADRS Scores During the Open-label Antidepressant Treatment|
11198454|NCT02178696|EG000|Reported Event|Placebo (Unknown)|
11198455|NCT02178696|EG001|Reported Event|Known Placebo|
11198456|NCT02178787|BG000|Baseline|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
11198457|NCT02178787|BG001|Baseline|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
11198458|NCT02178787|BG002|Baseline|Total|Total of all reporting groups
11198459|NCT02178787|FG000|Participant Flow|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
11198460|NCT02178787|FG001|Participant Flow|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
11198461|NCT02178787|OG000|Outcome|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
11198462|NCT02178787|OG001|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
11198463|NCT02178787|OG000|Outcome|Type 2 Diabetes Mellitus|Head-up tilt, vasoreactivity, standing up.
11198464|NCT02178787|OG001|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, standing up.
11198465|NCT02178787|EG000|Reported Event|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
11198466|NCT02178787|EG001|Reported Event|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
11198467|NCT02178800|BG000|Baseline|Group 1: GSK1265744|"Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~GSK1265744 Tablets: 30-mg tablets, taken orally~Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections~Cohort 2: 600-mg injection, administered as one IM gluteal injection"
11198468|NCT02178800|BG001|Baseline|Group 2: Placebo|"Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~Placebo for GSK1265744 Tablets: Taken orally~Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections~Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
11198469|NCT02178800|BG002|Baseline|Total|Total of all reporting groups
11198470|NCT02178800|FG000|Participant Flow|Group 1: GSK1265744|"Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~GSK1265744 Tablets: 30-mg tablets, taken orally~Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections~Cohort 2: 600-mg injection, administered as one IM gluteal injection"
11198471|NCT02178800|FG001|Participant Flow|Group 2: Placebo|"Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~Placebo for GSK1265744 Tablets: Taken orally~Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections~Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
11198472|NCT02178800|OG000|Outcome|Group 1: GSK1265744|"Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~GSK1265744 Tablets: 30-mg tablets, taken orally~Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections~Cohort 2: 600-mg injection, administered as one IM gluteal injection"
11198473|NCT02178800|OG001|Outcome|Group 2: Placebo|"Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~Placebo for GSK1265744 Tablets: Taken orally~Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections~Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
11198474|NCT02178800|OG000|Outcome|Female, Cohort 1|Female, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
11198475|NCT02178800|OG001|Outcome|Male, Cohort 1|Male, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
11198476|NCT02178800|OG002|Outcome|Female, Cohort 2|Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
11198477|NCT02178800|OG003|Outcome|Male, Cohort 2|Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
10965954|NCT00884793|BG000|Baseline|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
11242099|NCT02493088|FG000|Participant Flow|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
11198478|NCT02178800|OG000|Outcome|Cohort 1|Participants who were planned to receive IM injections of 744LA or placebo at three time points at 12 week intervals.Two sequential 400 mg gluteal injections were given at each injection visit (if not discontinued).
11198479|NCT02178800|OG001|Outcome|Cohort 2|participants who were planned to receive IM injections of 744LA or placebo at five time points at 4 and 8 week intervals.One 600 mg gluteal injection was given at each injection visit (if not discontinued).
11198480|NCT02178800|OG000|Outcome|Group 1: GSK1265744|"Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection"
11198481|NCT02178800|OG001|Outcome|Group 2: Placebo|"Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
11198482|NCT02178800|EG000|Reported Event|Group 1: GSK1265744|"Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~GSK1265744 Tablets: 30-mg tablets, taken orally~Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections~Cohort 2: 600-mg injection, administered as one IM gluteal injection"
11198483|NCT02178800|EG001|Reported Event|Group 2: Placebo|"Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.~Placebo for GSK1265744 Tablets: Taken orally~Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections~Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
11198484|NCT02178995|BG000|Baseline|Participants With Epilepsy|"Participants received three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time. Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed."
11198485|NCT02178995|BG001|Baseline|Healthy Controls|Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
11198486|NCT02178995|BG002|Baseline|Total|Total of all reporting groups
11198487|NCT02178995|FG000|Participant Flow|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
11198488|NCT02178995|FG001|Participant Flow|Healthy Controls|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
11198489|NCT02178995|FG002|Participant Flow|10mg, 20mg, Then Placebo (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11242100|NCT02493088|OG000|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
11242101|NCT02493088|EG000|Reported Event|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder were recorded during the study.~Adverse events were not related to the study.~Recorded adverse events were situations where subjects were harmed and required medical intervention."
11338465|NCT03611062|FG001|Participant Flow|Control|"Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions.~VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience."
11338466|NCT03611062|OG000|Outcome|VR Executive Functions Training|"Participants will receive training of executive functions in a virtual reality environment.~VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named Lubdub from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs."
11338467|NCT03611062|OG001|Outcome|Control|"Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions.~VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience."
11338468|NCT03611062|EG000|Reported Event|VR Executive Functions Training|"Participants will receive training of executive functions in a virtual reality environment.~VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named Lubdub from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs."
11338469|NCT03611062|EG001|Reported Event|Control|"Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions.~VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience."
11338470|NCT03611582|BG000|Baseline|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.
11338471|NCT03611582|BG001|Baseline|Placebo|Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
11338472|NCT03611582|BG002|Baseline|Total|Total of all reporting groups
11338473|NCT03611582|FG000|Participant Flow|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.
11338474|NCT03611582|FG001|Participant Flow|Placebo|Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
11338475|NCT03611582|OG000|Outcome|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.
11338476|NCT03611582|OG001|Outcome|Placebo|Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
11198490|NCT02178995|FG003|Participant Flow|10mg, Placebo, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11242102|NCT02493127|BG000|Baseline|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
11198491|NCT02178995|FG004|Participant Flow|Placebo, 20mg, Then 10mg (Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11198492|NCT02178995|FG005|Participant Flow|Placebo, 10mg, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
10800225|NCT02362503|EG000|Reported Event|Randomized Cohort-Placebo|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
11242103|NCT02493127|BG001|Baseline|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
11242104|NCT02493127|BG002|Baseline|Total|Total of all reporting groups
11242105|NCT02493127|FG000|Participant Flow|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
10800226|NCT02362503|EG001|Reported Event|Randomized Cohort-fostemsavir 600 mg BID|Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
10800227|NCT02362503|EG002|Reported Event|Non-randomized Cohort-fostemsavir 600 mg BID|This reporting group includes HTE HIV-1 infected participants who were assigned to the Non-randomized Cohort and received fostemsavir 600 mg BID and OBT. Non-randomized Cohort participants are assigned based on their screening status of having no remaining classes of fully active antiretroviral that can combined in a new drug regimen. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
10800228|NCT02362503|EG003|Reported Event|Randomized Cohort-Total|This reporting group includes all participants in the Randomized Cohort. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
10800229|NCT02362503|EG004|Reported Event|Total Fostemsavir|This reporting group included all enrolled participants (Randomized Cohort and Non-randomized Cohort) and who received fostemsavir 600 mg during the open-label period. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
10803606|NCT03093480|OG000|Outcome|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
11198493|NCT02178995|FG006|Participant Flow|20mg, Placebo, Then 10mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11198494|NCT02178995|FG007|Participant Flow|20mg, 10mg, Then Placebo - Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11242106|NCT02493127|FG001|Participant Flow|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
11198495|NCT02178995|FG008|Participant Flow|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
11198496|NCT02178995|OG000|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11198497|NCT02178995|OG001|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11198498|NCT02178995|OG002|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
11198499|NCT02178995|OG000|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
11198500|NCT02178995|OG001|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
11198501|NCT02178995|OG002|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
11198502|NCT02178995|OG003|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
11198503|NCT02178995|OG000|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198504|NCT02178995|OG001|Outcome|Participants With Epilepsy (Open-label Portion)|
11198505|NCT02178995|OG001|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
11198506|NCT02178995|OG001|Outcome|Participants With Epilepsy (Double-blind Portion)|
11198507|NCT02178995|OG001|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the questionnaire is specific to epilepsy populations, and the side-effects to AEDs, healthy controls did not complete the QOLIE-89.
11198508|NCT02178995|OG001|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the SSC is specific to medication side effects, healthy controls did not complete the questionnaire.
11198509|NCT02178995|EG000|Reported Event|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
11198510|NCT02178995|EG001|Reported Event|Placebo, 20mg, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 20mg of methylphenidate, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198511|NCT02178995|EG002|Reported Event|Placebo, 10mg, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 10mg of methylphenidate, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198512|NCT02178995|EG003|Reported Event|10mg, 20mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, 20mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198513|NCT02178995|EG004|Reported Event|10mg, Placebo, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, Placebo, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198514|NCT02178995|EG005|Reported Event|20mg, 10mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, 10mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198515|NCT02178995|EG006|Reported Event|20mg, Placebo, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, Placebo, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
11198516|NCT02178995|EG007|Reported Event|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
11198517|NCT02178995|EG008|Reported Event|Healthy Controls|Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only.
11198518|NCT02179047|BG000|Baseline|Stable Angina|receive coronary angiogram
11198519|NCT02179047|BG001|Baseline|Placebo|healthy subjects
11198520|NCT02179047|BG002|Baseline|Total|Total of all reporting groups
11198521|NCT02179047|FG000|Participant Flow|Intervention|patients with stable angina who received coronary angiography and percutaneous coronary intervention.
11198522|NCT02179047|FG001|Participant Flow|Placebo|healthy subjects
11198523|NCT02179047|OG000|Outcome|NGAL|biomarker
11198524|NCT02179047|OG001|Outcome|Cystatin C|biomarker
11198525|NCT02179047|OG002|Outcome|Galectin-3|biomarker
11198526|NCT02179047|OG003|Outcome|Copeptin|biomarker
11198527|NCT02179047|OG004|Outcome|MR-Pro ANP|biomarker
11198528|NCT02179047|OG005|Outcome|sST2|biomarker
11198529|NCT02179047|OG000|Outcome|NGAL|patients with stable angina who received coronary angiography.
11198530|NCT02179047|OG001|Outcome|Cystatin C|patients with stable angina who received coronary angiography.
11198531|NCT02179047|OG002|Outcome|Galectin-3|patients with stable angina who received coronary angiography.
11198532|NCT02179047|OG003|Outcome|Copeptin|patients with stable angina who received coronary angiography.
11242107|NCT02493127|OG000|Outcome|Standard Pain Catastrophizing Scale (PCS)|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
11242108|NCT02493127|OG000|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10800230|NCT02312258|BG000|Baseline|Placebo|Ixazomib placebo-matching capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
11242109|NCT02493127|OG000|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
11242110|NCT02493127|OG001|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
11198533|NCT02179047|OG004|Outcome|MR-Pro ANP|patients with stable angina who received coronary angiography.
11198534|NCT02179047|OG005|Outcome|sST2|patients with stable angina who received coronary angiography.
11198535|NCT02179047|OG006|Outcome|Placebo(Healthy Subjects)|patients without stable angina who received coronary angiography.
11198536|NCT02179047|EG000|Reported Event|Intervention|patients with worsen of angina symptoms after percutaneous coronary intervention.
11198537|NCT02179047|EG001|Reported Event|Placebo|patients with worsen of angina symptoms after percutaneous coronary intervention.
11198538|NCT02179177|BG000|Baseline|Apixaban|"Active drug Apixaban 2.5mg taken by mouth twice a day~Apixaban: Drug is taken by mouth twice a day for 6 months"
11198539|NCT02179177|BG001|Baseline|Placebo|"Sugar pills that look like Apixaban that will be taken by mouth twice a day~Placebo"
11198540|NCT02179177|BG002|Baseline|Total|Total of all reporting groups
10800231|NCT02312258|BG001|Baseline|Ixazomib|Ixazomib 3 mg, capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib 3 or 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800232|NCT02312258|BG002|Baseline|Total|Total of all reporting groups
10800233|NCT02312258|FG000|Participant Flow|Placebo|Ixazomib placebo-matching capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800234|NCT02312258|FG001|Participant Flow|Ixazomib|Ixazomib 3 mg, capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib 3 or 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800235|NCT02312258|OG000|Outcome|Placebo|Ixazomib placebo-matching capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800236|NCT02312258|OG001|Outcome|Ixazomib|Ixazomib 3 mg, capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib 3 or 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800237|NCT02312258|EG000|Reported Event|Placebo|Ixazomib placebo-matching capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
10800238|NCT02312258|EG001|Reported Event|Ixazomib|Ixazomib 3 mg, capsule, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib 3 or 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 (1st interim analysis data cut-off 12 August 2019).
11198541|NCT02179177|FG000|Participant Flow|Apixaban|"Active drug Apixaban 2.5mg taken by mouth twice a day~Apixaban: Drug is taken by mouth twice a day for 6 months"
10850756|NCT00304265|EG000|Reported Event|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
11198542|NCT02179177|FG001|Participant Flow|Placebo|"Sugar pills that look like Apixaban that will be taken by mouth twice a day~Placebo"
11198543|NCT02179177|OG000|Outcome|Apixaban|"Active drug Apixaban 2.5mg taken by mouth twice a day~Apixaban: Drug is taken by mouth twice a day for 6 months"
11198544|NCT02179177|OG001|Outcome|Placebo|"Sugar pills that look like Apixaban that will be taken by mouth twice a day~Placebo"
11198545|NCT02179177|EG000|Reported Event|Apixaban|"Active drug Apixaban 2.5mg taken by mouth twice a day~Apixaban: Drug is taken by mouth twice a day for 6 months"
11198546|NCT02179177|EG001|Reported Event|Placebo|"Sugar pills that look like Apixaban that will be taken by mouth twice a day~Placebo"
11198547|NCT02179190|BG000|Baseline|BARREL VRD|The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
11198548|NCT02179190|FG000|Participant Flow|BARREL VRD|The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
11198549|NCT02179190|OG000|Outcome|BARREL VRD|The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
11198550|NCT02179190|EG000|Reported Event|BARREL VRD|The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
11198551|NCT02179398|BG000|Baseline|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
11198552|NCT02179398|BG001|Baseline|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
11198553|NCT02179398|BG002|Baseline|Total|Total of all reporting groups
11198554|NCT02179398|FG000|Participant Flow|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
11198555|NCT02179398|FG001|Participant Flow|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
11198556|NCT02179398|OG000|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
11198557|NCT02179398|OG001|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.~(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
11198558|NCT02179398|OG000|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
11198559|NCT02179398|OG001|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
11198560|NCT02179398|OG000|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
11198561|NCT02179398|OG001|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
11198562|NCT02179398|EG000|Reported Event|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
11198563|NCT02179398|EG001|Reported Event|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
11198564|NCT02179424|BG000|Baseline|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198565|NCT02179424|BG001|Baseline|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198566|NCT02179424|BG002|Baseline|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198567|NCT02179424|BG003|Baseline|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198568|NCT02179424|BG004|Baseline|Total|Total of all reporting groups
11198569|NCT02179424|FG000|Participant Flow|Health Talk + Workshop + Booklet + SMS|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198570|NCT02179424|FG001|Participant Flow|Face-to-face Counseling + Booklet + SMS|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198571|NCT02179424|FG002|Participant Flow|Phone Counseling + Health Talk + Booklet + SMS|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198572|NCT02179424|FG003|Participant Flow|Phone Counseling + Booklet + SMS|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198573|NCT02179424|OG000|Outcome|Employers' KAP|Employers' knowledge on smoking and quitting
11198574|NCT02179424|OG000|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198575|NCT02179424|OG001|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198576|NCT02179424|OG002|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
10850939|NCT03410992|FG004|Participant Flow|Bimekizumab 320 mg Q4W/Q8W|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11198577|NCT02179424|OG003|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198578|NCT02179424|EG000|Reported Event|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198579|NCT02179424|EG001|Reported Event|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
10850940|NCT03410992|FG005|Participant Flow|Bimekizumab 320 mg Q4W/Q4W|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period.
11198580|NCT02179424|EG002|Reported Event|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198581|NCT02179424|EG003|Reported Event|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
11198582|NCT02179515|BG000|Baseline|Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 1 injection (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11242111|NCT02493127|EG000|Reported Event|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
10850757|NCT00304265|EG001|Reported Event|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
10800239|NCT02243605|BG000|Baseline|Ewing Sarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising."
10803939|NCT01049035|OG000|Outcome|Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11242112|NCT02493127|EG001|Reported Event|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
11198583|NCT02179515|BG001|Baseline|Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 2 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
10803940|NCT01049035|OG001|Outcome|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11338499|NCT03611829|EG000|Reported Event|Standard Care|"Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating.~Standard Care"
11338500|NCT03611829|EG001|Reported Event|ACT Intervention|"In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week.~ACT Intervention~Standard Care"
11338501|NCT03613129|BG000|Baseline|D0.01|Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
11338502|NCT03613129|BG001|Baseline|D0.03|Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
11338503|NCT03613129|BG002|Baseline|D0.06|Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
11338504|NCT03613129|BG003|Baseline|D0.20|Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
11338505|NCT03613129|BG004|Baseline|Total|Total of all reporting groups
11338506|NCT03613129|FG000|Participant Flow|Screen Failures|Patient enrolled, but screened-out before receiving treatment
11338507|NCT03613129|FG001|Participant Flow|D0.01|Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
11338508|NCT03613129|FG002|Participant Flow|D0.03|Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
11338509|NCT03613129|FG003|Participant Flow|D0.06|Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
11338510|NCT03613129|FG004|Participant Flow|D0.20|Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
11338511|NCT03613129|OG000|Outcome|Intent-to-treat|All patients receiving test drug
11338512|NCT03613129|OG001|Outcome|D0.01|Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
11338513|NCT03613129|OG002|Outcome|D0.03|Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
11338514|NCT03613129|OG003|Outcome|D0.06|Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
11338515|NCT03613129|OG004|Outcome|D0.20|Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
11338516|NCT03613129|EG000|Reported Event|Intent-to-treat|All patients receiving test drug
11338517|NCT03613129|EG001|Reported Event|D0.01|Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
11338518|NCT03613129|EG002|Reported Event|D0.03|Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
11338519|NCT03613129|EG003|Reported Event|D0.06|Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
11338520|NCT03613129|EG004|Reported Event|D0.20|Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
11338521|NCT03613454|BG000|Baseline|Splenic Artery Embolization With Vascular Embolic Coils|Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
11338522|NCT03613454|BG001|Baseline|Splenic Artery Embolization With Vascular Embolic Plugs|Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
11338523|NCT03613454|BG002|Baseline|Total|Total of all reporting groups
11338524|NCT03613454|FG000|Participant Flow|Splenic Artery Embolization With Vascular Embolic Coils|Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
11338525|NCT03613454|FG001|Participant Flow|Splenic Artery Embolization With Vascular Embolic Plugs|Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
11338526|NCT03613454|OG000|Outcome|Splenic Artery Embolization With Vascular Embolic Coils|Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
11338527|NCT03613454|OG001|Outcome|Splenic Artery Embolization With Vascular Embolic Plugs|Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
11338528|NCT03613454|EG000|Reported Event|Splenic Artery Embolization With Vascular Embolic Coils|Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
11338529|NCT03613454|EG001|Reported Event|Splenic Artery Embolization With Vascular Embolic Plugs|Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
11338530|NCT03613493|BG000|Baseline|HPV Self-sampling Kit + Interview|"Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative)."
11242113|NCT02493257|BG000|Baseline|Intranasal Capsaicin|"The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the MAD, 0.8 millimeters (0.8mL) will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Capsaicin"
11242114|NCT02493257|BG001|Baseline|Vehicle Solution|"100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Placebo"
10803607|NCT03093480|EG000|Reported Event|Recombinant Coagulation Factor VIII Fc (rFVIIIFc)|Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
10803608|NCT03077438|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10803609|NCT03077438|BG001|Baseline|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
10803610|NCT03077438|BG002|Baseline|Total|Total of all reporting groups
11242115|NCT02493257|BG002|Baseline|Total|Total of all reporting groups
10965955|NCT00884793|FG000|Participant Flow|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
10965956|NCT00884793|OG000|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
11198584|NCT02179515|BG002|Baseline|Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 4 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198585|NCT02179515|BG003|Baseline|Total|Total of all reporting groups
10803611|NCT03077438|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
10803612|NCT03077438|FG001|Participant Flow|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate vaccine on Day 0.
10803613|NCT03077438|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10803614|NCT03077438|OG001|Outcome|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
10803615|NCT03077438|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 5 years received a single dose of MenACYW Conjugate vaccine on Day 0.
10803616|NCT03077438|OG001|Outcome|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 5 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
10803617|NCT03077438|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 6 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
11198586|NCT02179515|FG000|Participant Flow|Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 1 injection (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
10803618|NCT03077438|OG001|Outcome|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 6 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
10803619|NCT03077438|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
11198587|NCT02179515|FG001|Participant Flow|Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOMvaccine administered subcutaneously as 2 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198588|NCT02179515|FG002|Participant Flow|Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 4 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198589|NCT02179515|OG000|Outcome|Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-TRICOM vaccine administered subcutaneously as 1 injection (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198590|NCT02179515|OG001|Outcome|Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-TRICOM vaccine administered subcutaneously as 2 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198591|NCT02179515|OG002|Outcome|Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-TRICOM vaccine administered subcutaneously as 4 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198592|NCT02179515|OG000|Outcome|All Participants|All participants in Dose Level 1 - 1 injection - Total Dose 2 x 10^8 IU, Dose Level 2 - 2 injections - Total Dose 4 x 10^8 IU, and Dose Level 3 - 4 injections - Total Dose 8 x 10^8 IU.
11198593|NCT02179515|OG000|Outcome|Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 1 injection (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198594|NCT02179515|OG001|Outcome|Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 2 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198595|NCT02179515|OG002|Outcome|Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 4 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198596|NCT02179515|EG000|Reported Event|Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 1 injection (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198597|NCT02179515|EG001|Reported Event|Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 2 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198598|NCT02179515|EG002|Reported Event|Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU|Participants received Modified Vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine administered subcutaneously as 4 injections (I injection = 2 x 10^8 IU) of study drug at monthly (28 days +/- 4 days) intervals for 3 months. Patients with stable disease may continue to receive vaccine for up to 6 monthly doses.
11198599|NCT02179671|BG000|Baseline|Gefitinib With a Seq. Switch to a MEDI4736|Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
11198600|NCT02179671|BG001|Baseline|Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736|Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
11198601|NCT02179671|BG002|Baseline|Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736|Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
11198602|NCT02179671|BG003|Baseline|Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736|TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
11198603|NCT02179671|BG004|Baseline|AZD9291 With a Seq. Switch to a MEDI4736|The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
11198604|NCT02179671|BG005|Baseline|Total|Total of all reporting groups
11198605|NCT02179671|FG000|Participant Flow|Gefitinib With a Seq. Switch to a MEDI4736|Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
11198606|NCT02179671|FG001|Participant Flow|AZD9291 With a Seq. Switch to a MEDI4736|The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
11198607|NCT02179671|FG002|Participant Flow|Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736|Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
11198608|NCT02179671|FG003|Participant Flow|Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736|Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
11198609|NCT02179671|FG004|Participant Flow|Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736|Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
10803620|NCT03077438|EG001|Reported Event|Group 2: MENVEO® Vaccine|Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
11198610|NCT02179671|OG000|Outcome|Gefitinib With a Seq. Switch to a MEDI4736|Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
11198611|NCT02179671|OG001|Outcome|AZD9291 With a Seq. Switch to a MEDI4736|The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
11198612|NCT02179671|OG002|Outcome|Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736|Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
10965957|NCT00884793|EG000|Reported Event|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
10803621|NCT03045653|BG000|Baseline|Treatment Arm|"receiving a treatment of tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy~Tamoxifen Oral Product: Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy"
10803622|NCT03045653|FG000|Participant Flow|Treatment Arm|receiving a treatment of tamoxifen 100 mg/d
10803623|NCT03045653|OG000|Outcome|Treatment Arm|receiving a treatment of tamoxifen 100 mg/d
10803624|NCT03045653|EG000|Reported Event|Treatment Arm|receiving a treatment of tamoxifen 100 mg/d
10965958|NCT00884806|BG000|Baseline|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
11198613|NCT02179671|OG003|Outcome|Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736|Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
11198614|NCT02179671|OG004|Outcome|Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736|Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
11198615|NCT02179671|EG000|Reported Event|Gefitinib With a Seq. Switch to a MEDI4736|Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
11198616|NCT02179671|EG001|Reported Event|Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736|Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
11198617|NCT02179671|EG002|Reported Event|AZD9291 With a Seq. Switch to MEDI4736|The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database.
10850941|NCT03410992|FG006|Participant Flow|Placebo Escape|Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
10850942|NCT03410992|FG007|Participant Flow|Bimekizumab 320 mg Q4W Escape|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11198618|NCT02179671|EG003|Reported Event|Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736|Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
11198619|NCT02179671|EG004|Reported Event|Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736|TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
11198620|NCT02179788|BG000|Baseline|Standard Care Plus Metformin|"10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.~Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.~Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, one 750 mg capsule with evening meal (750 mg/day)~Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)~Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)~The trial duration was28 days (with a +/- 3 day cushion)"
11198621|NCT02179788|BG001|Baseline|Standard Care Plus Placebo|"5 Stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm consumed methylcellulose USP Powder encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, take 1 capsule with evening meal~Days 8-14, take 3 capsules with evening meal~Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Standard care: Mothers were instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump."
11198622|NCT02179788|BG002|Baseline|Total|Total of all reporting groups
11198623|NCT02179788|FG000|Participant Flow|Standard Care Plus Metformin|"10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.~Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.~Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, one 750 mg capsule with evening meal (750 mg/day)~Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)~Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)~The trial duration was28 days (with a +/- 3 day cushion)"
11198624|NCT02179788|FG001|Participant Flow|Standard Care Plus Placebo|"5 Stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm consumed methylcellulose USP Powder encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, take 1 capsule with evening meal~Days 8-14, take 3 capsules with evening meal~Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Standard care: Mothers were instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump."
10800240|NCT02243605|BG001|Baseline|Osteosarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :~a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).~a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising."
10800241|NCT02243605|BG002|Baseline|Total|Total of all reporting groups
10803625|NCT02948959|BG000|Baseline|Placebo|Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
10965959|NCT00884806|FG000|Participant Flow|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
10965960|NCT00884806|OG000|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
11242116|NCT02493257|FG000|Participant Flow|Intranasal Capsaicin|"The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the mucosal atomizer device (MAD), 0.8 millimeters (mL) will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Capsaicin"
10850943|NCT03410992|FG008|Participant Flow|Bimekizumab 320 mg Q4W/ Placebo Escape|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
11198625|NCT02179788|OG000|Outcome|Standard Care Plus Metformin|"10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.~Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.~Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, one 750 mg capsule with evening meal (750 mg/day)~Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)~Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)~The trial duration was28 days (with a +/- 3 day cushion)"
11242117|NCT02493257|FG001|Participant Flow|Vehicle Solution|"100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Placebo"
10965961|NCT00884806|EG000|Reported Event|FID 114675A|Investigational multi-purpose contact lens solution
11242118|NCT02493257|OG000|Outcome|Intranasal Capsaicin|"The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the MAD, 0.8mL will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Capsaicin"
11242119|NCT02493257|OG001|Outcome|Vehicle Solution|"100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Placebo"
11198626|NCT02179788|OG001|Outcome|Standard Care Plus Placebo|"5 Stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm consumed methylcellulose USP Powder encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, take 1 capsule with evening meal~Days 8-14, take 3 capsules with evening meal~Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Standard care: Mothers were instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump."
11242120|NCT02493257|EG000|Reported Event|Intranasal Capsaicin|"The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the MAD, 0.8mL will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Capsaicin"
11242121|NCT02493257|EG001|Reported Event|Vehicle Solution|"100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.~Placebo"
10965962|NCT00884832|BG000|Baseline|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
11198627|NCT02179788|EG000|Reported Event|Standard Care Plus Metformin|"10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.~Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.~Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, one 750 mg capsule with evening meal (750 mg/day)~Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)~Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)~The trial duration was28 days (with a +/- 3 day cushion)"
11242122|NCT02493361|BG000|Baseline|Pembrolizumab and Intratumoral pIL-12 Electroporation|"Treatments of pembrolizumab and pIL-12 were given in three week cycles that repeated as long as there was benefit, for up to 24 months or until disease worsened. Some subjects had the option of continuing treatment beyond 24 months or after worsening of disease under limited circumstances.~Pembrolizumab: 200 mg dose is given intravenously, Day 1 of each cycle. pIL-12: Given by injection into the tumor at 1/4 tumor volume at concentration of 0.5 mg/mL, Days 1, 5, and 8 of each odd numbered cycle."
10965963|NCT00884832|BG001|Baseline|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
10965964|NCT00884832|BG002|Baseline|Total|Total of all reporting groups
10803626|NCT02948959|BG001|Baseline|Dupilumab|Dupilumab 200 mg (in 1.14 mL for >30 kg BW) or 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11242123|NCT02493361|FG000|Participant Flow|Pembrolizumab and Intratumoral pIL-12 Electroporation|"Treatments of pembrolizumab and pIL-12 were given in three week cycles that repeated as long as there was benefit, for up to 24 months or until disease worsened. Some subjects had the option of continuing treatment beyond 24 months or after worsening of disease under limited circumstances.~Pembrolizumab: 200 mg dose is given intravenously, Day 1 of each cycle. pIL-12: Given by injection into the tumor at 1/4 tumor volume at concentration of 0.5 mg/mL, Days 1, 5, and 8 of each odd numbered cycle."
10803627|NCT02948959|BG002|Baseline|Total|Total of all reporting groups
11198628|NCT02179788|EG001|Reported Event|Standard Care Plus Placebo|"5 Stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm consumed methylcellulose USP Powder encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~Days 1-7, take 1 capsule with evening meal~Days 8-14, take 3 capsules with evening meal~Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Standard care: Mothers were instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump."
10803628|NCT02948959|FG000|Participant Flow|Placebo|Placebo (for Dupilumab), subcutaneous (SC) injection every 2 weeks (q2w) for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., long-acting β2 agonist [LABA], long acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
10803629|NCT02948959|FG001|Participant Flow|Dupilumab|Dupilumab 200 milligrams (mg) (in 1.14 milliliters [mL] for >30 kilograms (kg) bodyweight [BW]) or 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11198629|NCT02179892|BG000|Baseline|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
11198630|NCT02179892|BG001|Baseline|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
11198631|NCT02179892|BG002|Baseline|Total|Total of all reporting groups
11198632|NCT02179892|FG000|Participant Flow|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) were administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block."
11198633|NCT02179892|FG001|Participant Flow|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection were administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
11198634|NCT02179892|OG000|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
10965965|NCT00884832|FG000|Participant Flow|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
11198635|NCT02179892|OG001|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
10965966|NCT00884832|FG001|Participant Flow|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
10965967|NCT00884832|OG000|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
10965968|NCT00884832|OG001|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
10965969|NCT00884832|EG000|Reported Event|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
10965970|NCT00884832|EG001|Reported Event|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
11198636|NCT02179892|EG000|Reported Event|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure~Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
10803630|NCT02948959|OG000|Outcome|Placebo|Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11198637|NCT02179892|EG001|Reported Event|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.~Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
11198638|NCT02179918|BG000|Baseline|PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198639|NCT02179918|BG001|Baseline|PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198640|NCT02179918|BG002|Baseline|PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198641|NCT02179918|BG003|Baseline|PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198642|NCT02179918|BG004|Baseline|PF-05082566 5 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198643|NCT02179918|BG005|Baseline|Total|Total of all reporting groups
11198644|NCT02179918|FG000|Participant Flow|PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg every 3 weeks (q3wks) on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198645|NCT02179918|FG001|Participant Flow|PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
10965971|NCT00884897|BG000|Baseline|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
10965972|NCT00884897|BG001|Baseline|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
10965973|NCT00884897|BG002|Baseline|Total|Total of all reporting groups
11198646|NCT02179918|FG002|Participant Flow|PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198647|NCT02179918|FG003|Participant Flow|PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198648|NCT02179918|FG004|Participant Flow|PF-05082566 5 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198649|NCT02179918|OG000|Outcome|PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198650|NCT02179918|OG001|Outcome|PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198651|NCT02179918|OG002|Outcome|PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198652|NCT02179918|OG003|Outcome|PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198653|NCT02179918|OG004|Outcome|PF-05082566 5 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198654|NCT02179918|OG005|Outcome|Total|Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
11198655|NCT02179918|EG000|Reported Event|PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198656|NCT02179918|EG001|Reported Event|PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198657|NCT02179918|EG002|Reported Event|PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198658|NCT02179918|EG003|Reported Event|PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.
11198659|NCT02179918|EG004|Reported Event|PF-05082566 5 mg/kg + MK-3475 2 mg/kg|PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
11198660|NCT02180061|BG000|Baseline|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198661|NCT02180061|BG001|Baseline|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198662|NCT02180061|BG002|Baseline|Total|Total of all reporting groups
11198663|NCT02180061|FG000|Participant Flow|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
11198664|NCT02180061|FG001|Participant Flow|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198665|NCT02180061|OG000|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198666|NCT02180061|OG001|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198667|NCT02180061|EG000|Reported Event|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198668|NCT02180061|EG001|Reported Event|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
11198669|NCT02180100|BG000|Baseline|Terconazole Vaginal Suppository|"Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days~Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days"
11198670|NCT02180100|BG001|Baseline|Fluconazole|"Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.~Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4."
11198671|NCT02180100|BG002|Baseline|Total|Total of all reporting groups
10965974|NCT00884897|FG000|Participant Flow|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
11198672|NCT02180100|FG000|Participant Flow|Terconazole Vaginal Suppository|"Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days~Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days"
11198673|NCT02180100|FG001|Participant Flow|Fluconazole|"Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.~Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4."
11198674|NCT02180100|OG000|Outcome|Terconazole Vaginal Suppository|"Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days~Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days"
11198675|NCT02180100|OG001|Outcome|Fluconazole|"Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.~Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4."
11198676|NCT02180100|EG000|Reported Event|Terconazole Vaginal Suppository|"Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days~Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days"
11198677|NCT02180100|EG001|Reported Event|Fluconazole|"Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.~Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4."
11198678|NCT02180165|BG000|Baseline|Cohort 1: Posaconazole|Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11242124|NCT02493361|OG000|Outcome|Pembrolizumab and Intratumoral pIL-12 Electroporation|"Treatments of pembrolizumab and pIL-12 were given in three week cycles that repeated as long as there was benefit, for up to 24 months or until disease worsened. Some subjects had the option of continuing treatment beyond 24 months or after worsening of disease under limited circumstances.~Pembrolizumab: 200 mg dose is given intravenously, Day 1 of each cycle. pIL-12: Given by injection into the tumor at 1/4 tumor volume at concentration of 0.5 mg/mL, Days 1, 5, and 8 of each odd numbered cycle."
11198679|NCT02180165|BG001|Baseline|Cohort 1: Voriconazole|Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198680|NCT02180165|BG002|Baseline|Cohort 2: Posaconazole|Participants from cohort 2 with invasive aspergillosis and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198681|NCT02180165|BG003|Baseline|Cohort 2: Voriconazole|Participants from cohort 2 with invasive aspergillosis and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198682|NCT02180165|BG004|Baseline|Total|Total of all reporting groups
11198683|NCT02180165|FG000|Participant Flow|Cohort 1: Posaconazole|Participants with chronic pulmonary aspergillosis or with fusariosis or zygomycosis, received 300 mg posaconazole oral tablet (or 300 mg intravenous [IV] solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198684|NCT02180165|FG001|Participant Flow|Cohort 1: Voriconazole|Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198685|NCT02180165|FG002|Participant Flow|Cohort 2: Posaconazole|Participants with aspergillosis or with fusariosis or zygomycosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198686|NCT02180165|FG003|Participant Flow|Cohort 2: Voriconazole|Participants with aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198687|NCT02180165|OG000|Outcome|Cohort 1: Posaconazole|Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198688|NCT02180165|OG001|Outcome|Cohort 1: Voriconazole|Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198689|NCT02180165|OG002|Outcome|Cohort 2: Posaconazole|Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198690|NCT02180165|OG003|Outcome|Cohort 2: Voriconazole|Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198691|NCT02180165|OG000|Outcome|Cohort 1: Posaconazole|Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198692|NCT02180165|OG002|Outcome|Cohort 2: Posaconazole|Participants from cohort 2 with zygomycosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198693|NCT02180165|EG000|Reported Event|Cohort 1: Posaconazole|Participants with chronic pulmonary aspergillosis or with fusariosis or zygomycosis, received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
11198694|NCT02180165|EG001|Reported Event|Cohort 1: Voriconazole|Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198695|NCT02180165|EG002|Reported Event|Cohort 2: Posaconazole|Participants with aspergillosis or with fusariosis or zygomycosis,received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days. Participants with fusariosis or zygomycosis, were also assigned to this treatment group
11198696|NCT02180165|EG003|Reported Event|Cohort 2: Voriconazole|Participants with aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
11198697|NCT02180230|BG000|Baseline|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
11198698|NCT02180230|FG000|Participant Flow|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
11198699|NCT02180230|OG000|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
11198700|NCT02180230|EG000|Reported Event|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
11198701|NCT02180438|BG000|Baseline|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
11198702|NCT02180438|FG000|Participant Flow|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
11198703|NCT02180438|OG000|Outcome|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
11198704|NCT02180438|EG000|Reported Event|Open Label Prospective Single Arm Study of Stribild|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
11198705|NCT02180646|BG000|Baseline|High Carb Then High Protein Breakfast|A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
11198706|NCT02180646|BG001|Baseline|High Protein Then High Carb Breakfast|A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
11198707|NCT02180646|BG002|Baseline|Total|Total of all reporting groups
11198708|NCT02180646|FG000|Participant Flow|High Carb Then High Protein Breakfast|A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
11198709|NCT02180646|FG001|Participant Flow|High Protein Then High Carb Breakfast|A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
11198710|NCT02180646|OG000|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
11198711|NCT02180646|OG001|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
11198712|NCT02180646|OG000|Outcome|High Carb Then High Protein Breakfast|"A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).~High protein breakfast: a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~High carb breakfast: a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)"
11198713|NCT02180646|OG001|Outcome|High Protein Then High Carb Breakfast|"A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~High protein breakfast: a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~High carb breakfast: a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)"
11198714|NCT02180646|EG000|Reported Event|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
11198715|NCT02180646|EG001|Reported Event|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
11198716|NCT02180659|BG000|Baseline|Buprenorphine Implants + Placebo Tablets|"Four 80 mg Probuphine implants + daily SL placebo tablets~Buprenorphine implant~sublingual placebo tablets"
11198717|NCT02180659|BG001|Baseline|Buprenorphine Tablets + Placebo Implants|"Daily SL BPN tablets (≤8 mg/daily) + four placebo implants~sublingual buprenorphine tablets~placebo implants"
11198718|NCT02180659|BG002|Baseline|Total|Total of all reporting groups
11198719|NCT02180659|FG000|Participant Flow|Buprenorphine Implants + Placebo Tablets|"Four 80 mg Probuphine implants + daily SL placebo tablets~Buprenorphine implant~sublingual placebo tablets"
11198720|NCT02180659|FG001|Participant Flow|Buprenorphine Tablets + Placebo Implants|"Daily SL BPN tablets (≤8 mg/daily) + four placebo implants~sublingual buprenorphine tablets~placebo implants"
11198721|NCT02180659|OG000|Outcome|Buprenorphine Implants + Placebo Tablets|"Four 80 mg Probuphine implants + daily SL placebo tablets~Buprenorphine implant~sublingual placebo tablets"
11198722|NCT02180659|OG001|Outcome|Buprenorphine Tablets + Placebo Implants|"Daily SL BPN tablets (≤8 mg/daily) + four placebo implants~sublingual buprenorphine tablets~placebo implants"
11198723|NCT02180659|EG000|Reported Event|Buprenorphine Implants + Placebo Tablets|"Four 80 mg Probuphine implants + daily SL placebo tablets~Buprenorphine implant~sublingual placebo tablets"
11198724|NCT02180659|EG001|Reported Event|Buprenorphine Tablets + Placebo Implants|"Daily SL BPN tablets (≤8 mg/daily) + four placebo implants~sublingual buprenorphine tablets~placebo implants"
11198725|NCT02180672|BG000|Baseline|Nasal Steroids|"Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).~Nasal Fluticasone: One spray per nostril, per day."
11198726|NCT02180672|BG001|Baseline|Placebo|"Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).~Placebo: One spray per nostril, per day."
11198727|NCT02180672|BG002|Baseline|Total|Total of all reporting groups
11198728|NCT02180672|FG000|Participant Flow|Nasal Steroids|"Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).~Nasal Fluticasone: One spray per nostril, per day."
11198729|NCT02180672|FG001|Participant Flow|Placebo|"Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).~Placebo: One spray per nostril, per day."
11198730|NCT02180672|OG000|Outcome|Nasal Steroids|"Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).~Nasal Fluticasone: One spray per nostril, per day."
11198731|NCT02180672|OG001|Outcome|Placebo|"Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).~Placebo: One spray per nostril, per day."
11198732|NCT02180672|EG000|Reported Event|Nasal Steroids|"Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).~Nasal Fluticasone: One spray per nostril, per day."
11198733|NCT02180672|EG001|Reported Event|Placebo|"Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).~Placebo: One spray per nostril, per day."
11198734|NCT02180828|BG000|Baseline|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
11198735|NCT02180828|BG001|Baseline|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
11198736|NCT02180828|BG002|Baseline|Total|Total of all reporting groups
11198737|NCT02180828|FG000|Participant Flow|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
11198738|NCT02180828|FG001|Participant Flow|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
11198739|NCT02180828|OG000|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
11198740|NCT02180828|OG001|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
11198741|NCT02180828|EG000|Reported Event|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
11198742|NCT02180828|EG001|Reported Event|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
11198743|NCT02180893|BG000|Baseline|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
11198744|NCT02180893|BG001|Baseline|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
11198745|NCT02180893|BG002|Baseline|Total|Total of all reporting groups
11198746|NCT02180893|FG000|Participant Flow|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
11198747|NCT02180893|FG001|Participant Flow|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
11198748|NCT02180893|OG000|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
11198749|NCT02180893|OG001|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
11198750|NCT02180893|EG000|Reported Event|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
11198751|NCT02180893|EG001|Reported Event|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
11198752|NCT02181075|BG000|Baseline|Part I|Arm I Patients
11198753|NCT02181075|BG001|Baseline|Part II|Arm II Patients
11198754|NCT02181075|BG002|Baseline|Total|Total of all reporting groups
11198755|NCT02181075|FG000|Participant Flow|Part I (Patients Enrolled Between March 2015-April 2017)|"Part I of the study was designed to identify optimal focused ultrasound (FUS) exposure parameters for a range of tumour locations within the liver, using real-time thermometry data from an implanted thermometry device (a thermistor or thermocouple). Patients in Part I receive a single cycle of Lyso- Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) intravenously, at a dose of of 50 mg/m2. After a minimum of five patients have received the Part I intervention with real-time thermometry, data was reviewed by the Trial Management Group (TMG) to confirm readiness to proceed without real-time thermometry in Part II of the study. Plasma and biopsy samples of the target liver tumour were taken pre-LTLD, post-LTLD and post- LTLD+FUS.~Parts I and II of the study were not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198756|NCT02181075|FG001|Participant Flow|Part II (Patients Enrolled Between June 2016-Feb 2017)|"Following a minimum of 5 Part I cases, and subject to Trial Management Group approval, Part II of the study was opened to run in parallel to Part I. Part II did not require implantation of a thermometry device, and instead used predictions from Part I data to set the FUS parameters. Targeted drug delivery in Part II thus proceeded completely non-invasively, and this part of the study was designed to more closely reflect how the therapy might be implemented in routine clinical practice.~Plasma samples were taken pre-LTLD, post-LTLD and post-LTLD+FUS. Biopsy samples of the target liver tumour were taken only post-LTLD+FUS.~Parts I and II of the study are not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198757|NCT02181075|OG000|Outcome|Part I (Patients Enrolled Between March 2015-April 2017)|"Part I of the study was designed to identify optimal focused ultrasound (FUS) exposure parameters for a range of tumour locations within the liver, using real-time thermometry data from an implanted thermometry device (a thermistor or thermocouple). Patients in Part I receive a single cycle of Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) intravenously, at a dose of of 50 mg/m2. After a minimum of five patients have received the Part I intervention with real-time thermometry, data was reviewed by the Trial Management Group (TMG) to confirm readiness to proceed without real-time thermometry in Part II of the study. Plasma and biopsy samples of the target liver tumour were taken pre-LTLD, post-LTLD and post-LTLD+FUS.~Parts I and II of the study were not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198758|NCT02181075|OG001|Outcome|Part II (Patients Enrolled Between June 2016-Feb 2017)|"Following a minimum of 5 Part I cases, and subject to Trial Management Group approval, Part II of the study was opened to run in parallel to Part I. Part II did not require implantation of a thermometry device, and instead used predictions from Part I data to set the FUS parameters. Targeted drug delivery in Part II thus proceeded completely non-invasively, and this part of the study was designed to more closely reflect how the therapy might be implemented in routine clinical practice.~Plasma samples were taken pre-LTLD, post-LTLD and post-LTLD+FUS. Biopsy samples of the target liver tumour were taken only post-LTLD+FUS. Parts I and II of the study are not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198759|NCT02181075|OG000|Outcome|Part I (Patients Enrolled Between March 2015-April 2017)|Arm 1 - see above
11198760|NCT02181075|OG001|Outcome|Part II (Patients Enrolled Between June 2016-Feb 2017)|Arm 2 - see above
11198761|NCT02181075|OG000|Outcome|Part I (July 2014-July 2017)|"Part I of the study was designed to identify optimal focused ultrasound (FUS) exposure parameters for a range of tumour locations within the liver, using real-time thermometry data from an implanted thermometry device (a thermistor or thermocouple). Patients in Part I receive a single cycle of Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®) intravenously, at a dose of of 50 mg/m2. After a minimum of five patients have received the Part I intervention with real-time thermometry, data was reviewed by the Trial Management Group (TMG) to confirm readiness to proceed without real-time thermometry in Part II of the study. Plasma and biopsy samples of the target liver tumour were taken pre-LTLD, post-LTLD and post-LTLD+FUS.~Parts I and II of the study were not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198762|NCT02181075|OG001|Outcome|Part II (May 2016-July 2017)|"Following a minimum of 5 Part I cases, and subject to Trial Management Group approval, Part II of the study was opened to run in parallel to Part I. Part II did not require implantation of a thermometry device, and instead used predictions from Part I data to set the FUS parameters. Targeted drug delivery in Part II thus proceeded completely non-invasively, and this part of the study was designed to more closely reflect how the therapy might be implemented in routine clinical practice.~Plasma samples were taken pre-LTLD, post-LTLD and post-LTLD+FUS. Biopsy samples of the target liver tumour were taken only post-LTLD+FUS. Parts I and II of the study are not randomised, and both Parts of the study are detailed further in the published protocol summary (https://doi.org/10.1186/s40349-017-0104-0)."
11198763|NCT02181075|EG000|Reported Event|Part I (Patients Enrolled Between March 2015-April 2017)|Arm 1 - see above
10965975|NCT00884897|FG001|Participant Flow|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
11198764|NCT02181075|EG001|Reported Event|Part II (Patients Enrolled Between June 2016-Feb 2017)|Arm 2 - see above
11198765|NCT02181127|BG000|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11198766|NCT02181127|FG000|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11198767|NCT02181127|OG000|Outcome|Glucagon-only Bionic Pancreas|Glucagon-only Bionic Pancreas delivered glucagon during 7 of the 14 days. The order of the glucagon days was randomized in blocks of 2, with no more than 2 days in a row of glucagon.
11198768|NCT02181127|OG001|Outcome|Placebo|Glucagon-only Bionic Pancreas delivered placebo during 7 of the 14 days. The order of the placebo days was randomized in blocks of 2, with no more than 2 days in a row of placebo.
11198769|NCT02181127|OG000|Outcome|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11198770|NCT02181127|OG000|Outcome|All Participants|All participants in the study, on both glucagon and placebo days
11198771|NCT02181127|EG000|Reported Event|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
10965976|NCT00884897|OG000|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
11198772|NCT02181140|BG000|Baseline|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
11198773|NCT02181140|FG000|Participant Flow|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
11198774|NCT02181140|OG000|Outcome|EUS Guided Pro Core FNA|EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
11198775|NCT02181140|OG000|Outcome|EUS Guided Pro Core FNA|EUS guided Pro core FNA: Histology samples (not cytology)
11198776|NCT02181140|OG000|Outcome|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
11198777|NCT02181140|EG000|Reported Event|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
11198778|NCT02181231|BG000|Baseline|Buprenorphine|Drug: buprenorphine Low-dose buprenorphine (range 0.2mg/day-2.0mg/day)
11198779|NCT02181231|BG001|Baseline|Placebo|Drug: matched placebo
11198780|NCT02181231|BG002|Baseline|Total|Total of all reporting groups
11198781|NCT02181231|FG000|Participant Flow|Buprenorphine|Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
11198782|NCT02181231|FG001|Participant Flow|Placebo|Drug: placebo Matched placebo
11198783|NCT02181231|OG000|Outcome|Buprenorphine|Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
11198784|NCT02181231|OG001|Outcome|Placebo|Drug: placebo Matched placebo
11198785|NCT02181231|EG000|Reported Event|Buprenorphine|Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
11198786|NCT02181231|EG001|Reported Event|Placebo|Drug: placebo Matched placebo
11198787|NCT02181296|BG000|Baseline|High Concentration Group|"0.2% ropivacaine~ropivacaine"
11198788|NCT02181296|BG001|Baseline|Lower Concentration Group|"0.1% ropivacaine~ropivacaine"
11198789|NCT02181296|BG002|Baseline|Total|Total of all reporting groups
11198790|NCT02181296|FG000|Participant Flow|High Concentration Group|"0.2% ropivacaine~ropivacaine"
11198791|NCT02181296|FG001|Participant Flow|Lower Concentration Group|"0.1% ropivacaine~ropivacaine"
11198792|NCT02181296|OG000|Outcome|High Concentration Group|"0.2% ropivacaine~ropivacaine"
11198793|NCT02181296|OG001|Outcome|Lower Concentration Group|"0.1% ropivacaine~ropivacaine"
11198794|NCT02181296|EG000|Reported Event|High Concentration Group|"0.2% ropivacaine~ropivacaine"
11198795|NCT02181296|EG001|Reported Event|Lower Concentration Group|"0.1% ropivacaine~ropivacaine"
11198796|NCT02181387|BG000|Baseline|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
11198797|NCT02181387|BG001|Baseline|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
11198798|NCT02181387|BG002|Baseline|Total|Total of all reporting groups
11242125|NCT02493361|EG000|Reported Event|Pembrolizumab and Intratumoral pIL-12 Electroporation|"Treatments of pembrolizumab and pIL-12 were given in three week cycles that repeated as long as there was benefit, for up to 24 months or until disease worsened. Some subjects had the option of continuing treatment beyond 24 months or after worsening of disease under limited circumstances.~Pembrolizumab: 200 mg dose is given intravenously, Day 1 of each cycle. pIL-12: Given by injection into the tumor at 1/4 tumor volume at concentration of 0.5 mg/mL, Days 1, 5, and 8 of each odd numbered cycle."
11198799|NCT02181387|FG000|Participant Flow|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
11198800|NCT02181387|FG001|Participant Flow|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
11198801|NCT02181387|OG000|Outcome|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
11198802|NCT02181387|OG001|Outcome|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
11198803|NCT02181387|EG000|Reported Event|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses~Acetaminophen: administered every 6 hours by mouth up to 3 doses"
11198804|NCT02181387|EG001|Reported Event|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses~Placebo"
11198805|NCT02181400|BG000|Baseline|NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198806|NCT02181400|BG001|Baseline|NIR Laser Treatment 100mW/cm2 Dose|"The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11242126|NCT02493452|BG000|Baseline|Matching Placebo|Placebo Tablets dosed once daily for 12 weeks
11242127|NCT02493452|BG001|Baseline|3.0 mg Plecanatide|Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
11242128|NCT02493452|BG002|Baseline|6.0 mg Plecanatide|Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
11242129|NCT02493452|BG003|Baseline|Total|Total of all reporting groups
11198807|NCT02181400|BG002|Baseline|NIR Laser Treatment 200mW/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198808|NCT02181400|BG003|Baseline|Total|Total of all reporting groups
11242130|NCT02493452|FG000|Participant Flow|Matching Placebo|Placebo Tablets dosed once daily for 12 weeks
11242131|NCT02493452|FG001|Participant Flow|3.0 mg Plecanatide|Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
11242132|NCT02493452|FG002|Participant Flow|6.0 mg Plecanatide|Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
10803631|NCT02948959|OG001|Outcome|Dupilumab|Dupilumab 200 mg (in 1.14 mL for >30 kg BW) or 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11242133|NCT02493452|OG000|Outcome|Matching Placebo|Placebo Tablets dosed once daily for 12 weeks
11242134|NCT02493452|OG001|Outcome|3.0 mg Plecanatide|Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
11198809|NCT02181400|FG000|Participant Flow|NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198810|NCT02181400|FG001|Participant Flow|NIR Laser Treatment 100mW/cm2 Dose|"The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198811|NCT02181400|FG002|Participant Flow|NIR Laser Treatment 200mW/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198812|NCT02181400|OG000|Outcome|NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198813|NCT02181400|OG001|Outcome|NIR Laser Treatment 100mW/cm2 Dose|"The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198814|NCT02181400|OG002|Outcome|NIR Laser Treatment 200mW/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198815|NCT02181400|EG000|Reported Event|NIR Laser Treatment 25 Miiliwatts (mW)/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11242135|NCT02493452|OG002|Outcome|6.0 mg Plecanatide|Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
11242136|NCT02493452|EG000|Reported Event|Matching Placebo|Placebo Tablets dosed once daily for 12 weeks
11242137|NCT02493452|EG001|Reported Event|3.0 mg Plecanatide|Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
11242138|NCT02493452|EG002|Reported Event|6.0 mg Plecanatide|Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
11242139|NCT02493517|BG000|Baseline|Lanreotide Autogel|Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
11242140|NCT02493517|BG001|Baseline|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242141|NCT02493517|BG002|Baseline|Total Title|
11242142|NCT02493517|FG000|Participant Flow|Lanreotide Autogel|Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered subcutaneously (s.c.) at a fixed dose of 90 milligrams (mg) every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg, administered every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by End of Study Treatment (EOST) / Early Withdrawal (EW) Visit at Week 33.
11242143|NCT02493517|FG001|Participant Flow|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered intramuscularly (i.m.) every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242144|NCT02493517|OG000|Outcome|Lanreotide Autogel|Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
11242145|NCT02493517|OG001|Outcome|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242146|NCT02493517|OG001|Outcome|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was adminsitered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242147|NCT02493517|OG001|Outcome|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m.every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242148|NCT02493517|EG000|Reported Event|Lanreotide Autogel|Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
11242149|NCT02493517|EG001|Reported Event|Lanreotide PR|Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
11242150|NCT02493608|BG000|Baseline|Scalpel Group|"Scalpel is the device used to make abdominal wall incision in this group of patient.~scalpel: used to cut the abdominal wall."
11242151|NCT02493608|BG001|Baseline|Diathermy Group|"In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.~Diathermy: Diathermy used to cut , coagulate the tissue"
11242152|NCT02493608|BG002|Baseline|Total|Total of all reporting groups
11242153|NCT02493608|FG000|Participant Flow|Scalpel Group|"Scalpel is the device used to make abdominal wall incision in this group of patient.~scalpel: used to cut the abdominal wall."
11242154|NCT02493608|FG001|Participant Flow|Diathermy Group|"In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.~Diathermy: Diathermy used to cut , coagulate the tissue"
11242155|NCT02493608|OG000|Outcome|Scalpel Group|"Scalpel is the device used to make abdominal wall incision in this group of patient.~scalpel: used to cut the abdominal wall."
11242156|NCT02493608|OG001|Outcome|Diathermy Group|"In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.~Diathermy: Diathermy used to cut , coagulate the tissue"
11242157|NCT02493608|EG000|Reported Event|Scalpel Group|"Scalpel is the device used to make abdominal wall incision in this group of patient.~scalpel: used to cut the abdominal wall."
11242158|NCT02493608|EG001|Reported Event|Diathermy Group|"In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.~Diathermy: Diathermy used to cut , coagulate the tissue"
11242159|NCT02493621|BG000|Baseline|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.
10803632|NCT02948959|OG000|Outcome|Placebo|Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11198816|NCT02181400|EG001|Reported Event|NIR Laser Treatment 100mW/cm2 Dose|"The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11242160|NCT02493621|BG001|Baseline|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11242161|NCT02493621|BG002|Baseline|Total|Total of all reporting groups
11242162|NCT02493621|FG000|Participant Flow|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.
11242163|NCT02493621|FG001|Participant Flow|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11242164|NCT02493621|OG000|Outcome|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.
11242165|NCT02493621|OG001|Outcome|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11242166|NCT02493621|EG000|Reported Event|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management.
11242167|NCT02493621|EG001|Reported Event|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11242168|NCT02493712|BG000|Baseline|High Dose|"High dose, twice a day for 6 weeks.~High dose: 6 capsules of IBD98-M, twice a day"
11242169|NCT02493712|BG001|Baseline|Placebo: C|"Placebo, twice a day~Placebo: Placebo"
11242170|NCT02493712|BG002|Baseline|Low Dose|"Low dose, twice a day for 6 weeks~Low dose: 4 capsules of IBD98-M"
11242171|NCT02493712|BG003|Baseline|Total|Total of all reporting groups
11242172|NCT02493712|FG000|Participant Flow|High Dose|"High dose, twice a day for 6 weeks.~High dose: 6 capsules of IBD98-M, twice a day"
11242173|NCT02493712|FG001|Participant Flow|Placebo: C|"Placebo, twice a day~Placebo: Placebo"
11242174|NCT02493712|FG002|Participant Flow|Low Dose|"Low dose, twice a day for 6 weeks~Low dose: 4 capsules of IBD98-M"
11242175|NCT02493712|OG000|Outcome|High Dose Group|IBD98-M 1.2 g/day group
11242176|NCT02493712|OG001|Outcome|Low Dose Group|IBD98-M 0.8 g/day group
11242177|NCT02493712|OG002|Outcome|Placebo|Placebo capsule, 6 capsules/day
11242178|NCT02493712|EG000|Reported Event|High Dose Group|IBD98-M 1.2 g/day group
11242179|NCT02493712|EG001|Reported Event|Low Dose Group|IBD98-M 0.8 g/day group
11242180|NCT02493712|EG002|Reported Event|Placebo|Placebo capsule, 6 capsules/day
11242181|NCT02493764|BG000|Baseline|IMI/REL|Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242182|NCT02493764|BG001|Baseline|PIP/TAZ|Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242183|NCT02493764|BG002|Baseline|Total|Total of all reporting groups
11242184|NCT02493764|FG000|Participant Flow|IMI/REL|Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a fixed dose combination (FDC) administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242185|NCT02493764|FG001|Participant Flow|PIP/TAZ|Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242186|NCT02493764|OG000|Outcome|IMI/REL|Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242187|NCT02493764|OG001|Outcome|PIP/TAZ|Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242188|NCT02493764|EG000|Reported Event|IMI/REL|Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242189|NCT02493764|EG001|Reported Event|PIP/TAZ|Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
11242190|NCT02493777|BG000|Baseline|HLD200 (Methylphenidate)|
11242191|NCT02493777|BG001|Baseline|Placebo|
11242192|NCT02493777|BG002|Baseline|Total|Total of all reporting groups
11242193|NCT02493777|FG000|Participant Flow|HLD200 (Methylphenidate)|Participants received HLD200 capsules (containing beads with methylphenidate in a dual-coated drug-layered core; optimzed at 20, 40, 60, 80 or 100 mg) orally once daily in the evening during a 1-week randomized (1:1), placebo-controlled, double-blind-period that followed a 6-week open-label HLD200 treatment-optimization period.
11242194|NCT02493777|FG001|Participant Flow|Placebo|Participants recieved placebo (matched to their dose-optimzed HLD200 capsules, but containing microcrystalline cellulose beads in place of methylphenidate) orally once daily in the evening during a 1-week randomized (1:1), placebo-controlled, double-blind period that followed a 6-week open-label HLD200 treatment-optimization period.
11198817|NCT02181400|EG002|Reported Event|NIR Laser Treatment 200mW/cm2 Dose|"The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.~Ellex Integre NIR laser: Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
11198818|NCT02181426|BG000|Baseline|0 mg of Ketorolac|"participant receives 0 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198819|NCT02181426|BG001|Baseline|7.5 mg of Ketorolac|"participant receives 7.5 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198820|NCT02181426|BG002|Baseline|15 mg Ketorolac|"participant receives 15 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198821|NCT02181426|BG003|Baseline|30 mg Ketorolac|"participant receives 30mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198822|NCT02181426|BG004|Baseline|Total|Total of all reporting groups
11242195|NCT02493777|OG000|Outcome|HLD200 (Methylphenidate)|
11242196|NCT02493777|OG001|Outcome|Placebo|
11198823|NCT02181426|FG000|Participant Flow|0 mg of Ketorolac|"participant receives 0 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11242197|NCT02493777|EG000|Reported Event|HLD200 (Methylphenidate)|
11242198|NCT02493777|EG001|Reported Event|Placebo|
10965977|NCT00884897|OG001|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
11198824|NCT02181426|FG001|Participant Flow|7.5 mg of Ketorolac|"participant receives 7.5 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198825|NCT02181426|FG002|Participant Flow|15 mg Ketorolac|"participant receives 15 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198826|NCT02181426|FG003|Participant Flow|30 mg Ketorolac|"participant receives 30mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198827|NCT02181426|OG000|Outcome|0 mg of Ketorolac|"participant receives 0 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198828|NCT02181426|OG001|Outcome|7.5 mg of Ketorolac|"participant receives 7.5 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198829|NCT02181426|OG002|Outcome|15 mg Ketorolac|"participant receives 15 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198830|NCT02181426|OG003|Outcome|30 mg Ketorolac|"participant receives 30mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198831|NCT02181426|EG000|Reported Event|0 mg of Ketorolac|"participant receives 0 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198832|NCT02181426|EG001|Reported Event|7.5 mg of Ketorolac|"participant receives 7.5 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198833|NCT02181426|EG002|Reported Event|15 mg Ketorolac|"participant receives 15 mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198834|NCT02181426|EG003|Reported Event|30 mg Ketorolac|"participant receives 30mg of Ketorolac~Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg)."
11198835|NCT02181504|BG000|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198836|NCT02181504|BG001|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198837|NCT02181504|BG002|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198838|NCT02181504|BG003|Baseline|Total|Total of all reporting groups
11198839|NCT02181504|FG000|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198840|NCT02181504|FG001|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198841|NCT02181504|FG002|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198842|NCT02181504|OG000|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198843|NCT02181504|OG001|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198844|NCT02181504|OG002|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198845|NCT02181504|OG000|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198846|NCT02181504|EG000|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198847|NCT02181504|EG001|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198848|NCT02181504|EG002|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198849|NCT02181517|BG000|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198850|NCT02181517|BG001|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11242199|NCT02493855|BG000|Baseline|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
10965978|NCT00884897|EG000|Reported Event|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
11198851|NCT02181517|BG002|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198852|NCT02181517|BG003|Baseline|Total|Total of all reporting groups
11198853|NCT02181517|FG000|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198854|NCT02181517|FG001|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198855|NCT02181517|FG002|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198856|NCT02181517|OG000|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198857|NCT02181517|OG001|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198858|NCT02181517|OG002|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198859|NCT02181517|EG000|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198860|NCT02181517|EG001|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
11198861|NCT02181517|EG002|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
11198862|NCT02181530|BG000|Baseline|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
11198863|NCT02181530|FG000|Participant Flow|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
11198864|NCT02181530|OG000|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
10965979|NCT00884897|EG001|Reported Event|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
11198865|NCT02181530|EG000|Reported Event|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
11198866|NCT02181556|BG000|Baseline|FOLFIRI + Aflibercept|"FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease~FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease~Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease"
11198867|NCT02181556|FG000|Participant Flow|FOLFIRI + Aflibercept|"FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease~FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease~Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease"
11198868|NCT02181556|OG000|Outcome|FOLFIRI + Aflibercept|"FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease~FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease~Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease"
11198869|NCT02181556|EG000|Reported Event|FOLFIRI and Aflibercept|"FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease~FOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease"
11198870|NCT02181634|BG000|Baseline|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
11198871|NCT02181634|FG000|Participant Flow|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
11198872|NCT02181634|OG000|Outcome|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
11198873|NCT02181634|EG000|Reported Event|Nab-Paclitaxel and Gemcitabine|"Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.~Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes."
11198874|NCT02181673|BG000|Baseline|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
11198875|NCT02181673|BG001|Baseline|Golimumab 2 mg/kg|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
11198876|NCT02181673|BG002|Baseline|Total|Total of all reporting groups
11198877|NCT02181673|FG000|Participant Flow|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
11198878|NCT02181673|FG001|Participant Flow|Placebo Then Golimumab 2 mg/kg (Week 24-60)|Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
11198879|NCT02181673|FG002|Participant Flow|Golimumab 2 mg/kg (Week 0-60)|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
11198880|NCT02181673|OG000|Outcome|Placebo|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
11198881|NCT02181673|OG001|Outcome|Golimumab|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
11198882|NCT02181673|EG000|Reported Event|Placebo (Week 0-24)|Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
11198883|NCT02181673|EG001|Reported Event|Placebo Then Golimumab 2 mg/kg (Week 24-60)|Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
11198884|NCT02181673|EG002|Reported Event|Golimumab 2 mg/kg (Week 0-60)|Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
11198885|NCT02181738|BG000|Baseline|Cohort A|Nivolumab 3mg/kg Q2wk, Brentuximab vedotin Naive
11198886|NCT02181738|BG001|Baseline|Cohort B|Nivolumab 3mg/kg Q2wk, Post Transplant Brentuximab vedotin
11198887|NCT02181738|BG002|Baseline|Cohort C|Nivolumab 3mg/kg Q2wk, Post Transplant with Brentuximab vedotin prior and or after ASCT
11198888|NCT02181738|BG003|Baseline|Cohort D|Nivolumab 240 mg IV Q2wk 8 doses monotherapy followed by twelve doses in combination with AVD
11198889|NCT02181738|BG004|Baseline|Total|Total of all reporting groups
11198890|NCT02181738|FG000|Participant Flow|Cohort A|Nivolumab 3mg/kg Q2wk, Brentuximab vedotin Naive
11198891|NCT02181738|FG001|Participant Flow|Cohort B|Nivolumab 3mg/kg Q2wk, Post Transplant Brentuximab vedotin
11198892|NCT02181738|FG002|Participant Flow|Cohort C|Nivolumab 3mg/kg Q2wk, Post Transplant with Brentuximab vedotin prior and or after ASCT
11198893|NCT02181738|FG003|Participant Flow|Cohort D|Nivolumab 240 mg IV Q2wk 8 doses monotherapy followed by twelve doses in combination with AVD
11198894|NCT02181738|OG000|Outcome|Cohort A|Nivolumab 3mg/kg Q2wk, Brentuximab vedotin Naive
11198895|NCT02181738|OG001|Outcome|Cohort B|Nivolumab 3mg/kg Q2wk, Post Transplant Brentuximab vedotin
11198896|NCT02181738|OG002|Outcome|Cohort C|Nivolumab 3mg/kg Q2wk, Post Transplant with Brentuximab vedotin prior and or after ASCT
11198897|NCT02181738|OG000|Outcome|Cohort D|Nivolumab 240 mg IV Q2wk 8 doses monotherapy followed by twelve doses in combination with AVD
11198898|NCT02181738|EG000|Reported Event|COHORT A|Nivolumab 3mg/kg Q2wk, Brentuximab vedotin Naive
11198899|NCT02181738|EG001|Reported Event|COHORT B|Nivolumab 3mg/kg Q2wk, Post Transplant Brentuximab vedotin
11198900|NCT02181738|EG002|Reported Event|COHORT C|Nivolumab 3mg/kg Q2wk, Post Transplant with Brentuximab vedotin prior and or after ASCT
11198901|NCT02181738|EG003|Reported Event|Cohort D|Nivolumab 240 mg IV Q2wk 8 doses monotherapy followed by twelve doses in combination with AVD
11198902|NCT02181803|BG000|Baseline|Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic|Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
11198903|NCT02181803|BG001|Baseline|Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic|Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14.
11198904|NCT02181803|BG002|Baseline|Part 1 Panel A & B Placebo Monotherapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11242200|NCT02493855|BG001|Baseline|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
11242201|NCT02493855|BG002|Baseline|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
11242202|NCT02493855|BG003|Baseline|Total|Total of all reporting groups
11198905|NCT02181803|BG003|Baseline|Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198906|NCT02181803|BG004|Baseline|Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
10803633|NCT02948959|OG000|Outcome|Placebo|Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dos medication ICS with second controller. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
10965980|NCT00884910|BG000|Baseline|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
11198907|NCT02181803|BG005|Baseline|Part 2 Panel C Placebo Add-on Therapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
11198908|NCT02181803|BG006|Baseline|Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy|Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198909|NCT02181803|BG007|Baseline|Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy|Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
11242203|NCT02493855|FG000|Participant Flow|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
11198910|NCT02181803|BG008|Baseline|Part 3 Panel D Placebo Monotherapy: Healthy|Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198911|NCT02181803|BG009|Baseline|Total|Total of all reporting groups
11198912|NCT02181803|FG000|Participant Flow|Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic|Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
11198913|NCT02181803|FG001|Participant Flow|Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic|Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198914|NCT02181803|FG002|Participant Flow|Part 1 Panel A & B Placebo Monotherapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198915|NCT02181803|FG003|Participant Flow|Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198916|NCT02181803|FG004|Participant Flow|Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
11198917|NCT02181803|FG005|Participant Flow|Part 2 Panel C Placebo Add-on Therapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
11198918|NCT02181803|FG006|Participant Flow|Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy|Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11242204|NCT02493855|FG001|Participant Flow|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
11242205|NCT02493855|FG002|Participant Flow|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
11242206|NCT02493855|OG000|Outcome|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
11242207|NCT02493855|OG001|Outcome|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
11242208|NCT02493855|OG002|Outcome|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
11242209|NCT02493855|EG000|Reported Event|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
11242210|NCT02493855|EG001|Reported Event|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
11242211|NCT02493855|EG002|Reported Event|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
11242212|NCT02493868|BG000|Baseline|All Participants|All Participants (direct entry and transferred entry) who were enrolled in this study and received intranasal esketamine, matching placebo and oral antidepressant as per the assigned treatment.
11242213|NCT02493868|FG000|Participant Flow|Intranasal Esketamine + Oral AD|Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.
11242214|NCT02493868|FG001|Participant Flow|Oral AD + Intranasal Placebo|Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance (MA) phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.
11242215|NCT02493868|OG000|Outcome|Intranasal Esketamine + Oral AD|Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.
11242216|NCT02493868|OG001|Outcome|Oral AD+ Intranasal Placebo|Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.
11242217|NCT02493868|EG000|Reported Event|IND: Intranasal Esketamine + Oral AD|Open-label induction (IND) phase (direct-entry participants only): received 56 milligram (mg) or 84 mg intranasal esketamine solution twice weekly with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]), once daily for 4 weeks.
11242218|NCT02493868|EG001|Reported Event|OP: Intranasal Esketamine + Oral AD|Optimization (OP) phase (both direct-entry and transferred-entry participants): received 56 mg or 84 mg intranasal esketamine solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks.
11242219|NCT02493868|EG002|Reported Event|MA: Intranasal Esketamine + Oral AD|Maintenance (MA) phase (both direct-entry and transferred-entry participants): received 56 mg or 84 mg intranasal esketamine solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily until relapse or study termination.
11198919|NCT02181803|FG007|Participant Flow|Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy|Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
11198920|NCT02181803|FG008|Participant Flow|Part 3 Panel D Placebo Monotherapy: Healthy|Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198921|NCT02181803|OG000|Outcome|Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198922|NCT02181803|OG001|Outcome|Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
11198923|NCT02181803|OG002|Outcome|Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
11198924|NCT02181803|OG003|Outcome|Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
11198925|NCT02181803|OG004|Outcome|Part 1 Panel A & B Placebo Monotherapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198926|NCT02181803|OG005|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198927|NCT02181803|OG006|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
11198928|NCT02181803|OG007|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
11198929|NCT02181803|OG008|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
11198930|NCT02181803|OG009|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
11198931|NCT02181803|OG010|Outcome|Part 2 Panel C Placebo Add-on Therapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
11198932|NCT02181803|OG011|Outcome|Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198933|NCT02181803|OG012|Outcome|Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
11198934|NCT02181803|OG013|Outcome|Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
11198935|NCT02181803|OG014|Outcome|Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
11198936|NCT02181803|OG015|Outcome|Part 3 Panel D Placebo Monotherapy: Healthy|Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198937|NCT02181803|OG000|Outcome|Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic|Participants received MK-8189 escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14 or alternatively 2 mg QD Days 1-4 and 4 mg QD Days 5-14
11198938|NCT02181803|OG001|Outcome|Part 1 Panel A & B Placebo Monotherapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198939|NCT02181803|OG002|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198940|NCT02181803|OG003|Outcome|Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
11198941|NCT02181803|OG004|Outcome|Part 2 Panel C Placebo Add-on Therapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
11198942|NCT02181803|OG005|Outcome|Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy|Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
11198943|NCT02181803|OG006|Outcome|Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy|Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
11198944|NCT02181803|OG007|Outcome|Part 3 Panel D Placebo Monotherapy: Healthy|Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198945|NCT02181803|EG000|Reported Event|Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198946|NCT02181803|EG001|Reported Event|Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
11198947|NCT02181803|EG002|Reported Event|Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
11198948|NCT02181803|EG003|Reported Event|Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic|Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
11198949|NCT02181803|EG004|Reported Event|Part 1 Panel A & B Placebo Monotherapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198950|NCT02181803|EG005|Reported Event|Part 1 Panel A & B Post Study: Schizophrenic|Participants with Schizophrenia who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
11198951|NCT02181803|EG006|Reported Event|Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198952|NCT02181803|EG007|Reported Event|Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
11198953|NCT02181803|EG008|Reported Event|Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
11198954|NCT02181803|EG009|Reported Event|Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
11198955|NCT02181803|EG010|Reported Event|Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic|Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
11198956|NCT02181803|EG011|Reported Event|Part 2 Panel C Placebo Add-on Therapy: Schizophrenic|Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
11198957|NCT02181803|EG012|Reported Event|Part 2 Panel C Post Study: Schizophrenic|Participants with Schizophrenia who received add-on therapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
11198958|NCT02181803|EG013|Reported Event|Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
11198959|NCT02181803|EG014|Reported Event|Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
11198960|NCT02181803|EG015|Reported Event|Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
11198961|NCT02181803|EG016|Reported Event|Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy|Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
11198962|NCT02181803|EG017|Reported Event|Part 3 Panel D Placebo Monotherapy: Healthy|Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
11198963|NCT02181803|EG018|Reported Event|Part 1 Panel D Post Study: Healthy|Healthy participants who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
11198964|NCT02181816|BG000|Baseline|Azilsartan/Amlodipine|Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
10800242|NCT02243605|FG000|Participant Flow|Ewing Sarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising."
11198965|NCT02181816|FG000|Participant Flow|Azilsartan/Amlodipine|Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11198966|NCT02181816|OG000|Outcome|Azilsartan/Amlodipine|Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
10965981|NCT00884910|FG000|Participant Flow|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
10965982|NCT00884910|OG000|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
11198967|NCT02181816|EG000|Reported Event|Azilsartan/Amlodipine|Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11242220|NCT02493868|EG003|Reported Event|MA: Oral AD + Intranasal Placebo|Maintenance phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), until relapse or study termination.
11242221|NCT02493868|EG004|Reported Event|FU: Intranasal Esketamine + Oral AD|Participants (who were non-responders in IND phase and who were in OP and MA phase at study termination) who received at least 1 dose of 56 mg or 84 mg intranasal esketamine participated in the follow-up (FU) phase. No intranasal esketamine was administered during FU phase. Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate.
10965983|NCT00884910|EG000|Reported Event|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
10965984|NCT00884949|BG000|Baseline|BMN 110|Dose-Escalation Period:
10965985|NCT00884949|FG000|Participant Flow|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
11198968|NCT02181829|BG000|Baseline|Whole Lung IMRT|"This is a single institution study involving patients with synovial sarcoma who have completed all standard therapy (e.g. surgery +/- radiation to the primary site) +/- any adjuvant chemotherapy. The sequence and types of therapy offered prior to WLI will likely vary based on primary tumor site, tumor resectability, extent of metastatic disease, performance status, and comorbidity. Each patient's therapy will be determined by the disease management team irrespective of participation on this protocol.~Whole Lung IMRT: External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments."
11198969|NCT02181829|FG000|Participant Flow|Whole Lung IMRT|"This is a single institution study involving patients with synovial sarcoma who have completed all standard therapy (e.g. surgery +/- radiation to the primary site) +/- any adjuvant chemotherapy. The sequence and types of therapy offered prior to WLI will likely vary based on primary tumor site, tumor resectability, extent of metastatic disease, performance status, and comorbidity. Each patient's therapy will be determined by the disease management team irrespective of participation on this protocol.~Whole Lung IMRT: External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments."
11198970|NCT02181829|OG000|Outcome|Whole Lung IMRT|"This is a single institution study involving patients with synovial sarcoma who have completed all standard therapy (e.g. surgery +/- radiation to the primary site) +/- any adjuvant chemotherapy. The sequence and types of therapy offered prior to WLI will likely vary based on primary tumor site, tumor resectability, extent of metastatic disease, performance status, and comorbidity. Each patient's therapy will be determined by the disease management team irrespective of participation on this protocol.~Whole Lung IMRT: External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments."
11198971|NCT02181829|EG000|Reported Event|Whole Lung IMRT|"This is a single institution study involving patients with synovial sarcoma who have completed all standard therapy (e.g. surgery +/- radiation to the primary site) +/- any adjuvant chemotherapy. The sequence and types of therapy offered prior to WLI will likely vary based on primary tumor site, tumor resectability, extent of metastatic disease, performance status, and comorbidity. Each patient's therapy will be determined by the disease management team irrespective of participation on this protocol.~Whole Lung IMRT: External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments."
11198972|NCT02181842|BG000|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11198973|NCT02181842|FG000|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11198974|NCT02181842|OG000|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11198975|NCT02181842|EG000|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
11198976|NCT02182115|BG000|Baseline|Standard of Care|"Surgeon's routine for preoperative showering. Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.~Other Name: Follow surgeon's instructions for pre-operative bathing."
11198977|NCT02182115|BG001|Baseline|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. Nasal mupirocin to applied inside nostrils twice daily."
11198978|NCT02182115|BG002|Baseline|Total|Total of all reporting groups
11198979|NCT02182115|FG000|Participant Flow|Standard of Care|"Surgeon's routine for preoperative showering.~standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery."
11198980|NCT02182115|FG001|Participant Flow|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily.~Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.~Nasal mupirocin to applied inside nostrils twice daily."
11198981|NCT02182115|OG000|Outcome|Standard of Care|"Surgeon's routine for preoperative showering.~standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery."
11198982|NCT02182115|OG001|Outcome|Antiseptic Bundle|"Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.~Chlorhexidine gluconate soap applied for bathing daily.~Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.~Nasal mupirocin to applied inside nostrils twice daily.~antiseptic bundle: 1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily."
11198983|NCT02182115|EG000|Reported Event|Standard of Care|Used surgeon recommended soap for two pre-op showers, one the night before and one the morning of surgery.
11198984|NCT02182115|EG001|Reported Event|Antiseptic Bundle|Used three drug antiseptic bundle for 5 days.
11198985|NCT02182440|BG000|Baseline|Placebo|One hour IV infusion of placebo once daily for 3 consecutive days
11198986|NCT02182440|BG001|Baseline|0.4 mg/kg (250 U/kg) recAP|One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
11198987|NCT02182440|BG002|Baseline|0.8 mg/kg (500 U/kg) recAP|One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
10965986|NCT00884949|OG000|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
10965987|NCT00884949|OG000|Outcome|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
11198988|NCT02182440|BG003|Baseline|1.6 mg/kg (1000 U/kg) recAP|One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
11198989|NCT02182440|BG004|Baseline|Total|Total of all reporting groups
10965988|NCT00884949|OG001|Outcome|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
10965989|NCT00884949|OG002|Outcome|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
10965990|NCT00884949|OG003|Outcome|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
10965991|NCT00884949|OG004|Outcome|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
10965992|NCT00884949|EG000|Reported Event|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
10965993|NCT00884949|EG001|Reported Event|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
10965994|NCT00884949|EG002|Reported Event|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
10965995|NCT00884949|EG003|Reported Event|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
10965996|NCT00884949|EG004|Reported Event|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
10965997|NCT00885079|BG000|Baseline|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
11198990|NCT02182440|FG000|Participant Flow|Placebo|One hour IV infusion of Placebo once daily for three consecutive days
10965998|NCT00885079|BG001|Baseline|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
10965999|NCT00885079|BG002|Baseline|Total|Total of all reporting groups
10966000|NCT00885079|FG000|Participant Flow|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
10966001|NCT00885079|FG001|Participant Flow|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
10966002|NCT00885079|OG000|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
10966003|NCT00885079|OG001|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
10966004|NCT00885079|EG000|Reported Event|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
10966005|NCT00885079|EG001|Reported Event|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
10966006|NCT00885092|BG000|Baseline|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
11198991|NCT02182440|FG001|Participant Flow|0.4 mg/kg (250 U/kg) recAP|One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
11198992|NCT02182440|FG002|Participant Flow|0.8 mg/kg (500 U/kg) recAP|One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
10966007|NCT00885092|BG001|Baseline|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
10966008|NCT00885092|BG002|Baseline|Total|Total of all reporting groups
10966009|NCT00885092|FG000|Participant Flow|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
10966010|NCT00885092|FG001|Participant Flow|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
10966011|NCT00885092|OG000|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
11198993|NCT02182440|FG003|Participant Flow|1.6 mg/kg (1000 U/kg) recAP|One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
11198994|NCT02182440|OG000|Outcome|Placebo|One hour IV infusion of Placebo once daily for three consecutive days
11198995|NCT02182440|OG001|Outcome|0.4 mg/kg (250 U/kg) recAP|One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
11198996|NCT02182440|OG002|Outcome|0.8 mg/kg (500 U/kg) recAP|One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
10966012|NCT00885092|OG001|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
10966013|NCT00885092|EG000|Reported Event|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
10966014|NCT00885092|EG001|Reported Event|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
10966015|NCT00885105|BG000|Baseline|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966016|NCT00885105|BG001|Baseline|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966017|NCT00885105|BG002|Baseline|Total|Total of all reporting groups
10966018|NCT00885105|FG000|Participant Flow|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966019|NCT00885105|FG001|Participant Flow|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966020|NCT00885105|OG000|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966021|NCT00885105|OG001|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966022|NCT00885105|EG000|Reported Event|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
11198997|NCT02182440|OG003|Outcome|1.6 mg/kg (1000 U/kg) recAP|One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
11198998|NCT02182440|OG002|Outcome|0.8 mg/kg (500U/kg) recAP|One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
11198999|NCT02182440|OG000|Outcome|Placebo|One hour IV infusion of placebo once daily for three consecutive days
11199000|NCT02182440|EG000|Reported Event|Placebo|One hour IV infusion of Placebo once daily for three consecutive days
11199001|NCT02182440|EG001|Reported Event|0.4 mg/kg (250 U/kg) recAP|One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
11199002|NCT02182440|EG002|Reported Event|0.8 mg/kg (500 U/kg) recAP|One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
11199003|NCT02182440|EG003|Reported Event|1.6 mg/kg (1000 U/kg) recAP|One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
11199004|NCT02182492|BG000|Baseline|Glucocorticoid|"Fluticasone propionate nasal spray~Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months"
10966023|NCT00885105|EG001|Reported Event|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
10966024|NCT00885118|BG000|Baseline|Placebo|Treatment with placebo once daily
10966025|NCT00885118|BG001|Baseline|Empa 1 mg|Treatment with Empa 1 mg once daily
10966026|NCT00885118|BG002|Baseline|Empa 5 mg|Treatment with Empa 5 mg once daily
10966027|NCT00885118|BG003|Baseline|Empa 10 mg|Treatment with Empa 10 mg once daily
10966028|NCT00885118|BG004|Baseline|Empa 25 mg|Treatment with Empa 25 mg once daily
10966029|NCT00885118|BG005|Baseline|Total|Total of all reporting groups
10966030|NCT00885118|FG000|Participant Flow|Placebo|Treatment with placebo once daily
11199005|NCT02182492|BG001|Baseline|Clarithromycin|"Clarithromycin tablet~Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months"
11199006|NCT02182492|BG002|Baseline|Total|Total of all reporting groups
11199007|NCT02182492|FG000|Participant Flow|Glucocorticoid|"Fluticasone propionate nasal spray~Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months"
11199008|NCT02182492|FG001|Participant Flow|Clarithromycin|"Clarithromycin tablet~Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months"
11199009|NCT02182492|OG000|Outcome|Glucocorticoid|"Fluticasone propionate nasal spray~Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months"
11199010|NCT02182492|OG001|Outcome|Clarithromycin|"Clarithromycin tablet~Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months"
11199011|NCT02182492|EG000|Reported Event|Glucocorticoid|"Fluticasone propionate nasal spray~Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months"
11199012|NCT02182492|EG001|Reported Event|Clarithromycin|"Clarithromycin tablet~Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months"
11199013|NCT02182804|BG000|Baseline|Study Arm|Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
11199014|NCT02182804|FG000|Participant Flow|Study Arm|Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
11199015|NCT02182804|OG000|Outcome|Study Arm|Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
11199016|NCT02182804|EG000|Reported Event|Study Arm|Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
11199017|NCT02182830|BG000|Baseline|Placebo|Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
11199018|NCT02182830|BG001|Baseline|Empagliflozin 10 Mg-25mg|Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
11199019|NCT02182830|BG002|Baseline|Total|Total of all reporting groups
11199020|NCT02182830|FG000|Participant Flow|Placebo|Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
11199021|NCT02182830|FG001|Participant Flow|Empagliflozin 10 Mg-25mg|Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
11199022|NCT02182830|OG000|Outcome|Placebo|Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
11199023|NCT02182830|OG001|Outcome|Empagliflozin 10 Mg-25mg|Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
11199024|NCT02182830|EG000|Reported Event|Placebo|Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
11199025|NCT02182830|EG001|Reported Event|Empagliflozin 10 Mg-25mg|Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
10966031|NCT00885118|FG001|Participant Flow|Empa 1 mg|Treatment with Empa 1 mg once daily
11199026|NCT02182843|BG000|Baseline|Cellentra VCBM|Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
11199027|NCT02182843|FG000|Participant Flow|Cellentra VCBM|Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
10966032|NCT00885118|FG002|Participant Flow|Empa 5 mg|Treatment with Empa 5 mg once daily
10966033|NCT00885118|FG003|Participant Flow|Empa 10 mg|Treatment with Empa 10 mg once daily
10966034|NCT00885118|FG004|Participant Flow|Empa 25 mg|Treatment with Empa 25 mg once daily
10966035|NCT00885118|OG000|Outcome|Placebo|Treatment with placebo once daily
10966036|NCT00885118|OG001|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
10966037|NCT00885118|OG002|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
10966038|NCT00885118|OG003|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
10966039|NCT00885118|OG004|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
10966040|NCT00885118|OG000|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
10966041|NCT00885118|OG001|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
11199028|NCT02182843|OG000|Outcome|Cellentra VCBM|Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
11199029|NCT02182843|EG000|Reported Event|Cellentra VCBM|Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
11199030|NCT02182895|BG000|Baseline|Saxagliptin Group|"DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.~Saxagliptin: 2.5-5 mg daily"
11199031|NCT02182895|BG001|Baseline|Standard Therapy Group|Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.
11199032|NCT02182895|BG002|Baseline|Total|Total of all reporting groups
11199033|NCT02182895|FG000|Participant Flow|Saxagliptin Group|saxagliptin 2.5-5 mg daily
11199034|NCT02182895|FG001|Participant Flow|Standard Therapy Group|No saxagliptin treatment
11199035|NCT02182895|OG000|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
11199036|NCT02182895|OG001|Outcome|Standard Therapy Group|No saxagliptin treatment
11199037|NCT02182895|EG000|Reported Event|Saxagliptin Group|saxagliptin 2.5-5 mg daily
11199038|NCT02182895|EG001|Reported Event|Standard Therapy Group|No saxagliptin treatment
10966042|NCT00885118|OG002|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
10966043|NCT00885118|OG003|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
10966044|NCT00885118|EG000|Reported Event|Placebo|Treatment with placebo once daily
10966045|NCT00885118|EG001|Reported Event|Empa 1 mg|Treatment with Empa 1 mg once daily
10966046|NCT00885118|EG002|Reported Event|Empa 5 mg|Treatment with Empa 5 mg once daily
10966047|NCT00885118|EG003|Reported Event|Empa 10 mg|Treatment with Empa 10 mg once daily
10966048|NCT00885118|EG004|Reported Event|Empa 25 mg|Treatment with Empa 25 mg once daily
10966049|NCT00885170|BG000|Baseline|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
11242222|NCT02493868|EG005|Reported Event|FU: Oral AD + Intranasal Placebo|Participants (who were non-responders in IND phase and who were in OP and MA phase at study termination) who received intranasal esketamine matching placebo with oral AD participated in the FU phase. Participants received oral AD for at least the 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate.
11242223|NCT02493868|EG006|Reported Event|OP_TEP: Oral AD + Intranasal Placebo|OP phase (transferred-entry participants [TEP]): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks.
11242224|NCT02493868|EG007|Reported Event|MA_TEP: Oral AD + Intranasal Placebo|Maintenance phase (transferred-entry participants): Participants were randomized (at the end of optimization phase) to intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR).
11242225|NCT02493946|BG000|Baseline|BTX-A-HAC Solution 50 U - DB Period|"During the DB period, subjects were randomised to receive a single treatment of BTX-A-HAC solution 50 U.~50 U (0.25 mL) BTX-A-HAC was administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive further BTX-A-HAC treatment."
10966050|NCT00885170|BG001|Baseline|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966051|NCT00885170|BG002|Baseline|Total|Total of all reporting groups
10966052|NCT00885170|FG000|Participant Flow|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
11242226|NCT02493946|BG001|Baseline|Placebo -DB Period|"During the DB period, subjects were randomised to receive a single treatment of placebo. 0.25 mL placebo was administered as five injections of 0.05 mL each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive BTX-A-HAC treatment."
11199039|NCT02182947|BG000|Baseline|Overall Study|Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
10966053|NCT00885170|FG001|Participant Flow|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966054|NCT00885170|OG000|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966055|NCT00885170|OG001|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966056|NCT00885170|EG000|Reported Event|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966057|NCT00885170|EG001|Reported Event|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
10966058|NCT00885352|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg once daily
10966059|NCT00885352|BG001|Baseline|Placebo|Placebo to sitagliptin once daily
10966060|NCT00885352|BG002|Baseline|Total|Total of all reporting groups
10966061|NCT00885352|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily
10966062|NCT00885352|FG001|Participant Flow|Placebo|Placebo to sitagliptin once daily
10966063|NCT00885352|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
10966064|NCT00885352|OG001|Outcome|Placebo|Placebo to sitagliptin once daily
10966065|NCT00885352|EG000|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
10966066|NCT00885352|EG001|Reported Event|Placebo|Placebo to sitagliptin once daily
10966067|NCT00885365|BG000|Baseline|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
10966068|NCT00885365|BG001|Baseline|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
10966069|NCT00885365|BG002|Baseline|Total|Total of all reporting groups
10966070|NCT00885365|FG000|Participant Flow|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
10966071|NCT00885365|FG001|Participant Flow|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
10966072|NCT00885365|OG000|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
10966073|NCT00885365|OG001|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
10966074|NCT00885365|EG000|Reported Event|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
10966075|NCT00885365|EG001|Reported Event|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
11242227|NCT02493946|BG002|Baseline|BTX-A-HAC Solution 50 U - LT Analyses de Novo Subjects|"Additional BTX-naïve (de novo) subjects were enrolled into the OL period to receive treatment with BTX-A-HAC during OL Cycle 1, and if eligible for retreatment de novo subjects received retreatment in OL Cycles 2 to 5.~Each treatment cycle included a single treatment with 50 U (0.25 mL) BTX-A-HAC administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region, and treatments were separated by at least 12 weeks."
10966076|NCT00885378|BG000|Baseline|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
10966077|NCT00885378|BG001|Baseline|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
10966078|NCT00885378|BG002|Baseline|Total|Total of all reporting groups
10966079|NCT00885378|FG000|Participant Flow|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
11199040|NCT02182947|FG000|Participant Flow|Overall Study|Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
11242228|NCT02493946|BG003|Baseline|Total|Total of all reporting groups
10966080|NCT00885378|FG001|Participant Flow|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
10966081|NCT00885378|OG000|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
11242229|NCT02493946|FG000|Participant Flow|BTX-A-HAC Solution 50 U - DB Period|"During the DB period, subjects were randomised to receive a single treatment of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC) solution 50 Units (U).~50 U (0.25 millilitres [mL]) BTX-A-HAC was administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive further BTX-A-HAC treatment."
10966082|NCT00885378|OG001|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
10966083|NCT00885378|EG000|Reported Event|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
10966084|NCT00885378|EG001|Reported Event|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
10966085|NCT00885482|BG000|Baseline|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
10966086|NCT00885482|FG000|Participant Flow|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
10966087|NCT00885482|OG000|Outcome|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
10966088|NCT00885482|EG000|Reported Event|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
11199041|NCT02182947|OG000|Outcome|Overall Study|Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
11199042|NCT02182947|EG000|Reported Event|Overall Study|Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE).
11199043|NCT02182973|BG000|Baseline|Donor Human Milk|"Term infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk~Donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks.~GI-subscores from the Finnegan NAS Scoring system will be computed."
11199044|NCT02182973|BG001|Baseline|Historical Control|Term infants identified with NAS requiring pharmacologic management in the previous year receiving formula feedings.
11199045|NCT02182973|BG002|Baseline|Total|Total of all reporting groups
11199046|NCT02182973|FG000|Participant Flow|Donor Human Milk|"Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk~donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks.~GI-subscores from the Finnegan NAS Scoring system will be computed."
11199047|NCT02182973|FG001|Participant Flow|Historical Control|Infants from the previous year with NAS but fed formula.
11199048|NCT02182973|OG000|Outcome|Donor Human Milk|"Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk~donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks.~GI-subscores from the Finnegan NAS Scoring system will be computed."
11199049|NCT02182973|OG001|Outcome|Historical Controls|Historical groups with NAS and receiving formula
11199050|NCT02182973|OG001|Outcome|Historical Control|Historical groups with NAS and receiving formula
11199051|NCT02182973|EG000|Reported Event|Donor Human Milk|"Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk~donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks.~GI-subscores from the Finnegan NAS Scoring system will be computed."
11199052|NCT02182973|EG001|Reported Event|Historical Control|Historical groups with NAS and receiving formula
11199053|NCT02182999|BG000|Baseline|NaCl 0,9%|"Continuous wound infiltration NaCl 0,9% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~NaCl 0,9%: The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11242230|NCT02493946|FG001|Participant Flow|Placebo - DB Period|"During the DB period, subjects were randomised to receive a single treatment of placebo. 0.25 mL placebo was administered as five injections of 0.05 mL each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive BTX-A-HAC treatment."
11199054|NCT02182999|BG001|Baseline|Ropivacaine|"Continuous wound infiltration with Ropivacaine 0,2% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~Ropivacaine: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11199055|NCT02182999|BG002|Baseline|Total|Total of all reporting groups
11199056|NCT02182999|FG000|Participant Flow|NaCl 0,9%|"Continuous wound infiltration NaCl 0,9% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~NaCl 0,9%: The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
10803634|NCT02948959|OG001|Outcome|Dupilumab|Dupilumab 200 mg (1.14 mL; for >30 kg bodyweight) or 100 mg (0.67 mL; for <=30 kg body weight), SC injection q2w for 50 weeks in combination with stable-dose background therapy of medium-dose ICS therapy with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
10803635|NCT02948959|OG000|Outcome|Placebo|Placebo (for Dupilumab), SC injection q2w for 50 weeks in combination with stable-dose background therapy of medium-dose ICS therapy with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11199057|NCT02182999|FG001|Participant Flow|Ropivacaine|"Continuous wound infiltration with Ropivacaine 0,2% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~Ropivacaine: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11199058|NCT02182999|OG000|Outcome|NaCl 0,9%|"Continuous wound infiltration NaCl 0,9% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~NaCl 0,9%: The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11199059|NCT02182999|OG001|Outcome|Ropivacaine|"Continuous wound infiltration with Ropivacaine 0,2% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~Ropivacaine: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11199060|NCT02182999|EG000|Reported Event|NaCl 0,9%|"Continuous wound infiltration NaCl 0,9% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~NaCl 0,9%: The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
10803636|NCT02948959|OG000|Outcome|Dupilumab 100mg q2w|Dupilumab 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
10803637|NCT02948959|OG001|Outcome|Dupilumab 200mg q2w|Dupilumab 200 mg (in 1.14 mL for >30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11338531|NCT03613493|BG001|Baseline|Culturally-targeted Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit."
11338532|NCT03613493|BG002|Baseline|Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit."
11338533|NCT03613493|BG003|Baseline|HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling."
11338534|NCT03613493|BG004|Baseline|Total|Total of all reporting groups
11338535|NCT03613493|FG000|Participant Flow|HPV Self-sampling Kit + Interview|"Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative)."
11338536|NCT03613493|FG001|Participant Flow|Culturally-targeted Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit."
11338537|NCT03613493|FG002|Participant Flow|Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit."
11338538|NCT03613493|FG003|Participant Flow|HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling."
11338539|NCT03613493|OG000|Outcome|Culturally-targeted Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit."
11338540|NCT03613493|OG001|Outcome|Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit."
11338541|NCT03613493|OG002|Outcome|HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling."
11338542|NCT03613493|OG003|Outcome|HPV Self-sampling Kit + Interview|"Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative)."
11338543|NCT03613493|EG000|Reported Event|HPV Self-sampling Kit + Interview|"Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative)."
11338544|NCT03613493|EG001|Reported Event|Culturally-targeted Fear Appeal Message HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.~Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit."
11338545|NCT03613493|EG002|Reported Event|HPV Self-sampling Kit|"Participants will receive an HPV self-sampling kit to screen for HPV~HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling."
11340652|NCT03661983|EG000|Reported Event|Open Label Stabilization Phase: Aripiprazole|Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
11199061|NCT02182999|EG001|Reported Event|Ropivacaine|"Continuous wound infiltration with Ropivacaine 0,2% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)~InfiltraLong-Katheter 19G x 420mm, Pajunk: Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.~Ropivacaine: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours."
11338587|NCT03613818|BG000|Baseline|eCHECKUP TO GO|"Brief, web-based alcohol intervention~eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking"
11338588|NCT03613818|BG001|Baseline|Control|Assessment only
11338589|NCT03613818|BG002|Baseline|Total|Total of all reporting groups
11338590|NCT03613818|FG000|Participant Flow|eCHECKUP TO GO|"Brief, web-based alcohol intervention~eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking"
11338591|NCT03613818|FG001|Participant Flow|Control|Assessment only
11338592|NCT03613818|OG000|Outcome|eCHECKUP TO GO|"Brief, web-based alcohol intervention~eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking"
11338593|NCT03613818|OG001|Outcome|Control|Assessment only
11338594|NCT03613818|EG000|Reported Event|eCHECKUP TO GO|"Brief, web-based alcohol intervention~eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking"
11338595|NCT03613818|EG001|Reported Event|Control|Assessment only
11338596|NCT03614078|BG000|Baseline|PRCL-02 25 Milligrams (mg)|"Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338597|NCT03614078|BG001|Baseline|PRCL-02 50 mg|"Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338598|NCT03614078|BG002|Baseline|Placebo|"Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks~Placebo: Oral tablets"
11338599|NCT03614078|BG003|Baseline|Total|Total of all reporting groups
11338600|NCT03614078|FG000|Participant Flow|PRCL-02 25 Milligrams (mg)|"Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338601|NCT03614078|FG001|Participant Flow|PRCL-02 50 mg|"Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338602|NCT03614078|FG002|Participant Flow|Placebo|"Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks~Placebo: Oral tablets"
11338603|NCT03614078|OG000|Outcome|PRCL-02 25 Milligrams (mg)|"Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338604|NCT03614078|OG001|Outcome|PRCL-02 50 mg|"Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338605|NCT03614078|OG002|Outcome|Placebo|"Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks~Placebo: Oral tablets"
11338606|NCT03614078|EG000|Reported Event|PRCL-02 25 Milligrams (mg)|"Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338607|NCT03614078|EG001|Reported Event|PRCL-02 50 mg|"Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks~PRCL-02: Oral tablets"
11338608|NCT03614078|EG002|Reported Event|Placebo|"Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks~Placebo: Oral tablets"
11338609|NCT03614130|BG000|Baseline|LID011121 (OD) / Biofinity (OS)|LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338610|NCT03614130|BG001|Baseline|Biofinity (OD) / LID011121 (OS)|Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338611|NCT03614130|BG002|Baseline|Total|Total of all reporting groups
11338612|NCT03614130|FG000|Participant Flow|LID011121 (OD) / Biofinity (OS)|LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338613|NCT03614130|FG001|Participant Flow|Biofinity (OD) / LID011121 (OS)|Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338614|NCT03614130|OG000|Outcome|LID011121|LID011121 contact lens worn in the right eye or left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338615|NCT03614130|OG001|Outcome|Biofinity|Comfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 6 nights of extended (overnight) wear
11338616|NCT03614130|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
11338617|NCT03614130|EG001|Reported Event|LID011121 - Ocular|Events reported in this group occurred while exposed to the LID011121 contact lenses
11338618|NCT03614130|EG002|Reported Event|Biofinity - Ocular|Events reported in this group occurred while exposed to the comfilcon A contact lenses
11338619|NCT03614130|EG003|Reported Event|Nonocular/Systemic|Events reported in this group occurred during exposure to the study contact lenses
11338620|NCT03614156|BG000|Baseline|DBTP Placebo Weekly|Placebo (prefilled syringe, weekly IV administration)
11338621|NCT03614156|BG001|Baseline|DBTP Rapastinel Clinically Driven Schedule|Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
11338622|NCT03614156|BG002|Baseline|DBTP Rapastinel Weekly|Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
11338623|NCT03614156|BG003|Baseline|Total|Total of all reporting groups
11338624|NCT03614156|FG000|Participant Flow|Open-Label Treatment Period (OLTP) Weekly Rapastinel|Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
11199062|NCT02183519|BG000|Baseline|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199063|NCT02183519|BG001|Baseline|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199064|NCT02183519|BG002|Baseline|Total|Total of all reporting groups
11199065|NCT02183519|FG000|Participant Flow|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199066|NCT02183519|FG001|Participant Flow|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11338625|NCT03614156|FG001|Participant Flow|DBTP Placebo Weekly|Placebo (prefilled syringe, weekly IV administration)
11338626|NCT03614156|FG002|Participant Flow|DBTP Rapastinel Clinically Driven Schedule|Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
11338627|NCT03614156|FG003|Participant Flow|DBTP Rapastinel Weekly|Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
11338628|NCT03614156|OG000|Outcome|DBTP Placebo Weekly|Placebo (prefilled syringe, weekly IV administration)
11338629|NCT03614156|OG001|Outcome|DBTP Rapastinel Clinically Driven Schedule|Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
11338630|NCT03614156|OG002|Outcome|DBTP Rapastinel Weekly|Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
11338631|NCT03614156|EG000|Reported Event|Open-Label Treatment Period|Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
11338632|NCT03614156|EG001|Reported Event|DBTP Placebo Weekly|Placebo (prefilled syringe, weekly IV administration)
11338633|NCT03614156|EG002|Reported Event|DBTP Rapastinel Clinically Driven Schedule|Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
11338634|NCT03614156|EG003|Reported Event|DBTP Rapastinel Weekly|Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
11338635|NCT03614416|BG000|Baseline|EOXY Device and Gold Standard Oximeter and SaO2 Measures|"Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11338636|NCT03614416|FG000|Participant Flow|EOXY Device and Gold Standard Oximeter and SaO2 Measures|"Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11338637|NCT03614416|OG000|Outcome|EOXY Device and Gold Standard Oximeter and SaO2 Measures|"Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11199067|NCT02183519|OG000|Outcome|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11338661|NCT03615183|BG003|Baseline|Panel D: ≤50 mg MK-8527|Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
11338662|NCT03615183|BG004|Baseline|Panel E: ≤50 mg MK-8527|Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
11338663|NCT03615183|BG005|Baseline|Total|Total of all reporting groups
11338664|NCT03615183|FG000|Participant Flow|Panel A: MK-8527 10 mg|Single oral dose of 10 mg MK-8527 in capsule form after an 8-hour fast
11338665|NCT03615183|FG001|Participant Flow|Panel B: MK-8527 3 mg|Single oral dose of 3 mg MK-8527 in capsule form after an 8-hour fast
11338666|NCT03615183|FG002|Participant Flow|Panel C: MK-8527 1 mg|Single oral dose of 1 mg MK-8527 in capsule form after an 8-hour fast
11338667|NCT03615183|FG003|Participant Flow|Panel D: ≤50 mg MK-8527|Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
11338668|NCT03615183|FG004|Participant Flow|Panel E: ≤50 mg MK-8527|Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
11338669|NCT03615183|OG000|Outcome|Panel A: MK-8527 10 mg|Single oral dose of 10 mg MK-8527 in capsule form after an 8-hour fast
11338670|NCT03615183|OG001|Outcome|Panel B: MK-8527 3 mg|Single oral dose of 3 mg MK-8527 in capsule form after an 8-hour fast
11338671|NCT03615183|OG002|Outcome|Panel C: MK-8527 1 mg|Single oral dose of 1 mg MK-8527 in capsule form after an 8-hour fast
11338672|NCT03615183|EG000|Reported Event|Panel A: MK-8527 10 mg|Single oral dose of 10 mg MK-8527 in capsule form after an 8-hour fast
11338673|NCT03615183|EG001|Reported Event|Panel B: MK-8527 3 mg|Single oral dose of 3 mg MK-8527 in capsule form after an 8-hour fast
11338674|NCT03615183|EG002|Reported Event|Panel C: MK-8527 1 mg|Single oral dose of 1 mg MK-8527 in capsule form after an 8-hour fast
11338675|NCT03615404|BG000|Baseline|CMV-DCs With GM-CSF and Td (Tetanus Toxoid)|CMV-DCs are autologous dendritic cells derived from peripheral blood mononuclear cells (PBMCs) loaded with ribonucleic acid (RNA) encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF and Td vaccine as adjuvants.
11338676|NCT03615404|FG000|Participant Flow|CMV-DCs With GM-CSF and Td (Tetanus Toxoid)|CMV-DCs are autologous dendritic cells derived from peripheral blood mononuclear cells (PBMCs) loaded with ribonucleic acid (RNA) encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF and Td vaccine as adjuvants.
11338677|NCT03615404|OG000|Outcome|CMV-DCs With GM-CSF and Td (Tetanus Toxoid)|CMV-DCs are autologous dendritic cells derived from peripheral blood mononuclear cells (PBMCs) loaded with ribonucleic acid (RNA) encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF and Td vaccine as adjuvants.
11338678|NCT03615404|EG000|Reported Event|CMV-DCs With GM-CSF and Td (Tetanus Toxoid)|CMV-DCs are autologous dendritic cells derived from peripheral blood mononuclear cells (PBMCs) loaded with ribonucleic acid (RNA) encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF and Td vaccine as adjuvants.
11338679|NCT03615482|BG000|Baseline|Concomitant Group|Participants received a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.
11338680|NCT03615482|BG001|Baseline|Non-Concomitant Group|Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30.
11338681|NCT03615482|BG002|Baseline|Total|Total of all reporting groups
11338682|NCT03615482|FG000|Participant Flow|Concomitant Group|Participants received a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of quadrivalent influenza vaccine (QIV) on Day 1 and a single 0.5 mL injection of placebo on Day 30.
11338683|NCT03615482|FG001|Participant Flow|Non-Concomitant Group|Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30.
11338684|NCT03615482|OG000|Outcome|Concomitant Group|Participants received a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.
11338685|NCT03615482|OG001|Outcome|Non-Concomitant Group|Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30.
11338686|NCT03615482|EG000|Reported Event|Concomitant Group (V114, QIV, Placebo)|Participants received a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.
11338687|NCT03615482|EG001|Reported Event|Noncomitant Group (Placebo, QIV, V114)|Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30.
11338688|NCT03615534|BG000|Baseline|Placebo|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Placebo"
11338689|NCT03615534|BG001|Baseline|Fenofibrate Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate"
11340653|NCT03661983|EG001|Reported Event|Double Blind Phase: Aripiprazole Full Dose|Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-blind Phase.
11340654|NCT03661983|EG002|Reported Event|Double Blind Phase: Aripiprazole Half Dose|Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
11340655|NCT03661983|EG003|Reported Event|Double Blind Phase: Placebo|Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
11340656|NCT03662074|BG000|Baseline|Treatment (Gemcitabine, Nivolumab)|"Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity~Gemcitabine: Given IV~Nivolumab: Given IV"
11340657|NCT03662074|FG000|Participant Flow|Treatment (Gemcitabine, Nivolumab)|"Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity~Gemcitabine: Given IV~Nivolumab: Given IV"
11340658|NCT03662074|OG000|Outcome|Treatment (Gemcitabine, Nivolumab)|"Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity~Gemcitabine: Given IV~Nivolumab: Given IV"
11340659|NCT03662074|EG000|Reported Event|Treatment (Gemcitabine, Nivolumab)|"Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity~Gemcitabine: Given IV~Nivolumab: Given IV"
11340660|NCT03662139|BG000|Baseline|Cerebral Palsy Group|"16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340661|NCT03662139|BG001|Baseline|Healthy Control Group|"16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340662|NCT03662139|BG002|Baseline|Total|Total of all reporting groups
11340663|NCT03662139|FG000|Participant Flow|Cerebral Palsy Group|"16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340664|NCT03662139|FG001|Participant Flow|Healthy Control Group|"16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340665|NCT03662139|OG000|Outcome|Cerebral Palsy Group|"16 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340666|NCT03662139|OG001|Outcome|Healthy Control Group|"16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators~Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions"
11340667|NCT03662139|OG000|Outcome|Cerebral Palsy Group|16 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators
11340668|NCT03662139|OG001|Outcome|Healthy Control Group|16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators
11340669|NCT03662139|EG000|Reported Event|Cerebral Palsy Group|16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other balance assessments will be performed twice with a 7 - 10 day interval by two evaluators
11340670|NCT03662139|EG001|Reported Event|Healthy Control Group|16 healthy children will be included. Dynamic Gait Index and other balance assessments will be performed twice with a 7 - 10 day interval by two evaluators
11340671|NCT03662282|BG000|Baseline|Drug - Omegaven®|These infants were more than one month old with history of long-term TPN dependence due to intestinal problem.
11340672|NCT03662282|FG000|Participant Flow|Drug - Omegaven®|Participants were screened based on inclusion and exclusion criteria. If and when a participant was qualified for Omegaven treatment, we sent FDA and application for IND approval. After the approval, the participant received Omegaven daily per protocol until cholestatsis resolved.
11340673|NCT03662282|OG000|Outcome|Drug - Omegaven®|Omegaven treatment group
11340674|NCT03662282|EG000|Reported Event|Drug - Omegaven®|Omegaven treatment group
11340675|NCT03662334|BG000|Baseline|Hyaluronidase Human Injection/Sham Injection|Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
11340676|NCT03662334|BG001|Baseline|Sham Injection/Hyaluronidase Human Injection|Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
11340677|NCT03662334|BG002|Baseline|Total|Total of all reporting groups
11340678|NCT03662334|FG000|Participant Flow|Hyaluronidase Human Injection/Sham Injection|Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
11199068|NCT02183519|OG001|Outcome|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199069|NCT02183519|EG000|Reported Event|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199070|NCT02183519|EG001|Reported Event|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
11199071|NCT02183675|BG000|Baseline|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
11340679|NCT03662334|FG001|Participant Flow|Sham Injection/Hyaluronidase Human Injection|Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
11340680|NCT03662334|OG000|Outcome|Hyaluronidase Human Injection/Sham Injection|Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
11340681|NCT03662334|OG001|Outcome|Sham Injection/Hyaluronidase Human Injection|Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
11340682|NCT03662334|EG000|Reported Event|Hyaluronidase Human Injection|Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.
11340683|NCT03662334|EG001|Reported Event|Sham Injection|Participants received pretreatment of 1 mL sham injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.
11340684|NCT03662360|BG000|Baseline|GROUP A - Control Group|16 patients who respect the inclusion criteria, treated with psychotropic drugs.
11340685|NCT03662360|BG001|Baseline|GROUP B - Aromatherapy Group|"16 patients included in the inclusion criteria, treated with psychotropic drugs and, in a complementary way, with diffusion aromatherapy~essential oils: Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders"
11340686|NCT03662360|BG002|Baseline|Total|Total of all reporting groups
11340687|NCT03662360|FG000|Participant Flow|GROUP A - Control Group|16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
11340688|NCT03662360|FG001|Participant Flow|GROUP B - Aromatherapy Group|"16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy~essential oils: Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders"
11340689|NCT03662360|OG000|Outcome|GROUP A - Control Group|16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
11340690|NCT03662360|OG001|Outcome|GROUP B - Aromatherapy Group|"16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy~essential oils: Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders"
11340691|NCT03662360|OG001|Outcome|GROUP B - Aromatherapy Group|16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy
11340692|NCT03662360|EG000|Reported Event|GROUP A - Control Group|16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
11340693|NCT03662360|EG001|Reported Event|GROUP B - Aromatherapy Group|"14 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy~essential oils: Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders"
11340694|NCT03662750|BG000|Baseline|Acute Stroke Cohort|Participants with recent stroke
11340695|NCT03662750|FG000|Participant Flow|Acute Stroke Cohort|Participants with recent stroke
11340696|NCT03662750|OG000|Outcome|Acute Stroke Cohort|Participants with recent stroke
11340697|NCT03662750|EG000|Reported Event|Acute Stroke Cohort|Participants with recent stroke
11199072|NCT02183675|BG001|Baseline|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
10803941|NCT01049035|OG001|Outcome|Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
10803638|NCT02948959|OG001|Outcome|Dupilumab 100mg q2w|Dupilumab 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11340698|NCT03662789|BG000|Baseline|Iron Isomaltoside 1000|"The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer (on-label treatment).~Iron Isomaltoside 1000: Intravenous infusion"
11340699|NCT03662789|BG001|Baseline|Placebo|"Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%~Placebo: NaCl 0,9%: Intravenous infusion"
11340700|NCT03662789|BG002|Baseline|Total|Total of all reporting groups
11340701|NCT03662789|FG000|Participant Flow|Iron Isomaltoside 1000|"The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer (on-label treatment).~Iron Isomaltoside 1000: Intravenous infusion"
11340702|NCT03662789|FG001|Participant Flow|Placebo|"Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%~Placebo: NaCl 0,9%: Intravenous infusion"
11340703|NCT03662789|OG000|Outcome|Iron Isomaltoside 1000|"The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer (on-label treatment).~Iron Isomaltoside 1000: Intravenous infusion"
11340704|NCT03662789|OG001|Outcome|Placebo|"Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%~Placebo: NaCl 0,9%: Intravenous infusion"
11340705|NCT03662789|EG000|Reported Event|Iron Isomaltoside 1000|"The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer (on-label treatment).~Iron Isomaltoside 1000: Intravenous infusion"
11340706|NCT03662789|EG001|Reported Event|Placebo|"Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%~Placebo: NaCl 0,9%: Intravenous infusion"
11340707|NCT03662997|BG000|Baseline|Hydropolymer vs Five-layer|Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks
11340708|NCT03662997|BG001|Baseline|Five-layer vs Hydropolymer|Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks
11340709|NCT03662997|BG002|Baseline|Hydrocellular vs Five-layer|Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks
11340710|NCT03662997|BG003|Baseline|Five-layer vs Hydrocellular|Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks
11340711|NCT03662997|BG004|Baseline|Total|Total of all reporting groups
11340712|NCT03662997|FG000|Participant Flow|Hydropolymer vs Five-layer|Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks
11340713|NCT03662997|FG001|Participant Flow|Five-layer vs Hydropolymer|Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks
11340714|NCT03662997|FG002|Participant Flow|Hydrocellular vs Five-layer|Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks
11340715|NCT03662997|FG003|Participant Flow|Five-layer vs Hydrocellular|Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks
11340716|NCT03662997|OG000|Outcome|Five-layer vs Hydropolymer|"The following two arms were combined into one cohort:~Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks"
11340717|NCT03662997|OG001|Outcome|Five-layer vs Hydrocellular|"The following two arms were combined into one cohort:~Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks"
11340718|NCT03662997|OG000|Outcome|Five-layer vs Hydropolymer|"This arm was divided into 2 treatment groups:~Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks"
11340719|NCT03662997|OG001|Outcome|Five-layer vs Hydrocellular|"This arm was divided into 2 treatment groups:~Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks"
11340720|NCT03662997|OG000|Outcome|Five-layer vs Hydropolymer|"This arm was divided into 2 treatment groups:~Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.~Bordered Five-Layer Foam Dressing: Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology~Hydropolymer Foam Dressing: Hydropolymer, adhesive foam island dressing"
11340721|NCT03662997|OG001|Outcome|Five-layer vs Hydrocellular|"This arm was divided into 2 treatment groups:~Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks~Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.~Bordered Five-Layer Foam Dressing: Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology~Hydrocellular Multi-Layer Foam Dressing: Multi-layered, hydrocellular foam dressing with silicone adhesive"
11340722|NCT03662997|EG000|Reported Event|Hydropolymer, Then Five-layer|Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
11340723|NCT03662997|EG001|Reported Event|Five-layer, Then Hydropolymer|Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
11340724|NCT03662997|EG002|Reported Event|Hydrocellular, Then Five-layer|Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
11340725|NCT03662997|EG003|Reported Event|Five-layer, Then Hydrocellular|Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
11340726|NCT03663101|BG000|Baseline|Placebo|Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.
11340727|NCT03663101|BG001|Baseline|Dysport 2.5 U/Injection Site|Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.
10803639|NCT02948959|OG002|Outcome|Dupilumab 200mg q2w|Dupilumab 200 mg (in 1.14 mL for >30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11340728|NCT03663101|BG002|Baseline|Dysport 10 U/Injection Site|Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.
11340729|NCT03663101|BG003|Baseline|Dysport 20 U/Injection Site|Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
11340730|NCT03663101|BG004|Baseline|Total|Total of all reporting groups
11340731|NCT03663101|FG000|Participant Flow|Placebo|Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 milliliters (mL).
11340732|NCT03663101|FG001|Participant Flow|Dysport 2.5 U/Injection Site|Participants received a single dose of Dysport 2.5 units (U) intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.
11340733|NCT03663101|FG002|Participant Flow|Dysport 10 U/Injection Site|Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.
11340734|NCT03663101|FG003|Participant Flow|Dysport 20 U/Injection Site|Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
11340735|NCT03663101|OG000|Outcome|Placebo|Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.
11340736|NCT03663101|OG001|Outcome|Dysport 2.5 U/Injection Site|Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.
11340737|NCT03663101|OG002|Outcome|Dysport 10 U/Injection Site|Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.
11340738|NCT03663101|OG003|Outcome|Dysport 20 U/Injection Site|Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
11340739|NCT03663101|EG000|Reported Event|Placebo|Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1. Injections were performed under a constant volume of 0.2 mL.
11340740|NCT03663101|EG001|Reported Event|Dysport 2.5 U/Injection Site|Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U. Injections were performed under a constant volume of 0.2 mL.
11340741|NCT03663101|EG002|Reported Event|Dysport 10 U/Injection Site|Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U. Injections were performed under a constant volume of 0.2 mL.
11340742|NCT03663101|EG003|Reported Event|Dysport 20 U/Injection Site|Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U. Injections were performed under a constant volume of 0.2 mL.
11340743|NCT03663179|BG000|Baseline|Active TMS|"Participants will receive 20 sessions of active TMS targeting the left DLPFC.~Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340744|NCT03663179|BG001|Baseline|Sham TMS|"Participants will receive 20 sessions of sham TMS over the left DLPFC.~Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11340745|NCT03663179|BG002|Baseline|Total|Total of all reporting groups
11340746|NCT03663179|FG000|Participant Flow|Active TMS|"Participants will receive 20 sessions of active TMS targeting the left DLPFC.~Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks)."
11199073|NCT02183675|BG002|Baseline|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
11199074|NCT02183675|BG003|Baseline|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
11199075|NCT02183675|BG004|Baseline|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
11199076|NCT02183675|BG005|Baseline|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
11199077|NCT02183675|BG006|Baseline|Total|Total of all reporting groups
11199078|NCT02183675|FG000|Participant Flow|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
11199079|NCT02183675|FG001|Participant Flow|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
11199080|NCT02183675|FG002|Participant Flow|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
11199081|NCT02183675|FG003|Participant Flow|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
11338690|NCT03615534|BG002|Baseline|WMER Niacin Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338691|NCT03615534|BG003|Baseline|Combination Therapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338692|NCT03615534|BG004|Baseline|Total|Total of all reporting groups
11338693|NCT03615534|FG000|Participant Flow|Placebo|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Placebo"
11338694|NCT03615534|FG001|Participant Flow|Fenofibrate Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate"
11338695|NCT03615534|FG002|Participant Flow|WMER Niacin Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338696|NCT03615534|FG003|Participant Flow|Combination Therapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338697|NCT03615534|OG000|Outcome|Placebo|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Placebo"
11338698|NCT03615534|OG001|Outcome|Fenofibrate Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate"
11338699|NCT03615534|OG002|Outcome|WMER Niacin Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338700|NCT03615534|OG003|Outcome|Combination Therapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate~Wax Matrix Extended Release Niacin (WMER Niacin)"
11338701|NCT03615534|EG000|Reported Event|Placebo|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Placebo"
11338702|NCT03615534|EG001|Reported Event|Fenofibrate Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate"
11338703|NCT03615534|EG002|Reported Event|WMER Niacin Monotherapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Wax Matrix Extended Release Niacin (WMER Niacin)"
11342302|NCT03704467|BG000|Baseline|Part A: Carboplatin + M6620 + Avelumab|Participants received intravenous infusion of Carboplatin area under the concentration-time curve 5 on Day 1 in combination with 90 milligrams per square meter (mg/m^2) of M6620 on Day 2 and avelumab at an established dose of 1600 mg over 60 minutes on Day 1 for every 3 weeks cycle for a maximum of 6 cycles. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11342303|NCT03704467|FG000|Participant Flow|Part A: Carboplatin + M6620 + Avelumab|Participants received intravenous infusion of Carboplatin area under the concentration-time curve 5 on Day 1 in combination with 90 milligrams per square meter (mg/m^2) of M6620 on Day 2 and avelumab at an established dose of 1600 mg over 60 minutes on Day 1 for every 3 weeks cycle for a maximum of 6 cycles. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11342304|NCT03704467|OG000|Outcome|Part A: Carboplatin + M6620 + Avelumab|Participants received intravenous infusion of Carboplatin area under the concentration-time curve 5 on Day 1 in combination with 90 milligrams per square meter (mg/m^2) of M6620 on Day 2 and avelumab at an established dose of 1600 mg over 60 minutes on Day 1 for every 3 weeks cycle for a maximum of 6 cycles. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11342305|NCT03704467|EG000|Reported Event|Part A: Carboplatin + M6620 + Avelumab|Participants received intravenous infusion of Carboplatin area under the concentration-time curve 5 on Day 1 in combination with 90 milligrams per square meter (mg/m^2) of M6620 on Day 2 and avelumab at an established dose of 1600 mg over 60 minutes on Day 1 for every 3 weeks cycle for a maximum of 6 cycles. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
11342306|NCT03705273|BG000|Baseline|Dexamethasone IV for PO|"Dexamethasone IV for PO solution mixed with sugar syrup to be given orally~Dexamethasone IV for PO: Common pediatric emergency department practice"
11342307|NCT03705273|BG001|Baseline|Dexamethasone Crushed Tablets|Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup
11342308|NCT03705273|BG002|Baseline|Total|Total of all reporting groups
11342309|NCT03705273|FG000|Participant Flow|Dexamethasone Tablets|Dexamethasone tablets crushed and administered in apple sauce or pudding at a dose of 0.6 mg/kg
11342310|NCT03705273|FG001|Participant Flow|Dexamethasone-IV Solution-in-syrup|Dexamethasone-IV solution-in-syrup at a dose of 0.6 mg/kg
11342311|NCT03705273|OG000|Outcome|Dexamethasone Tablets|Dexamethasone tablets crushed and mixed in apple sauce
11342312|NCT03705273|OG001|Outcome|Dexamethasone IV for PO|Dexamethasone IV solution mixed with cherry syrup
11342313|NCT03705273|EG000|Reported Event|Dexamethasone IV for PO|"Dexamethasone IV for PO solution mixed with sugar syrup to be given orally~Dexamethasone IV for PO: Common pediatric emergency department practice"
11342314|NCT03705273|EG001|Reported Event|Dexamethasone Crushed Tablets|"Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally~Dexamethasone crushed tablets: Alternative route of administration for patients unable to swallow tablet whole"
11342315|NCT03705481|BG000|Baseline|Age at Time of Consent|Age at the time of consent for the subjects that had a CorPath robotic PCI procedure performed remotely.
11342316|NCT03705481|FG000|Participant Flow|Remote Treatment of PCI.|"5 sequential subjects presenting for remote PCI who have signed informed consent.~Remote treatment of PCI.: To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures."
11342317|NCT03705481|OG000|Outcome|Device Technical Success|Number of participants that had a successful completion of the ReMOTE robotic-assisted PCI absent unplanned conversion to manual.
11342318|NCT03705481|OG000|Outcome|In-hospital MACE|MACE that occurs within 48 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with CorPath GRX.
11342319|NCT03705481|OG000|Outcome|Clinical Procedural Success|Defined as less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX POP System
11342320|NCT03705481|OG000|Outcome|All Serious Adverse Events|ll Serious Adverse Events (SAEs) from the start of the Re- MOTE CorPath procedure until the end of the study.
11342321|NCT03705481|EG000|Reported Event|Remote Treatment of PCI.|"5 sequential subjects presenting for remote PCI who have signed informed consent.~Remote treatment of PCI.: To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures."
11342322|NCT03705494|BG000|Baseline|Home-based Peer Counselling Intervention|"Women planning to breastfeed who meet the study's inclusion criteria~Home-based peer counselling intervention: The intervention consists of 5-6 home based visits over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme."
11342323|NCT03705494|BG001|Baseline|Standard Usual Care|Women planning to breastfeed who meet the study's inclusion criteria
11342324|NCT03705494|BG002|Baseline|Total|Total of all reporting groups
11342325|NCT03705494|FG000|Participant Flow|Home-based Peer Counselling Intervention|"Women planning to breastfeed who meet the study's inclusion criteria~Home-based peer counselling intervention: The intervention consists of 5-6 home based visits over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme."
11342326|NCT03705494|FG001|Participant Flow|Standard Usual Care|Women planning to breastfeed who meet the study's inclusion criteria
11342327|NCT03705494|OG000|Outcome|Home-based Peer Counselling Intervention|"Women planning to breastfeed who meet the study's inclusion criteria~Home-based peer counselling intervention: The intervention consists of 5-6 home based visits over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme."
11342328|NCT03705494|OG001|Outcome|Standard Usual Care|Women planning to breastfeed who meet the study's inclusion criteria
11342329|NCT03705494|EG000|Reported Event|Home-based Peer Counselling Intervention|"Women planning to breastfeed who meet the study's inclusion criteria~Home-based peer counselling intervention: The intervention consists of 5-6 home based visits over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme."
11342330|NCT03705494|EG001|Reported Event|Standard Usual Care|Women planning to breastfeed who meet the study's inclusion criteria
11342331|NCT03705793|BG000|Baseline|Mometasone Furoate Nasal Irrigation|"The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Furoate Nasal Irrigation: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray."
11342332|NCT03705793|BG001|Baseline|Mometasone Nasal Spray|"The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray."
11342333|NCT03705793|BG002|Baseline|Total|Total of all reporting groups
11342334|NCT03705793|FG000|Participant Flow|Mometasone Furoate Nasal Irrigation|"The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Furoate Nasal Irrigation: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray."
11342335|NCT03705793|FG001|Participant Flow|Mometasone Nasal Spray|"The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray."
11342336|NCT03705793|OG000|Outcome|Mometasone Furoate Nasal Irrigation|"The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Furoate Nasal Irrigation: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray."
11342337|NCT03705793|OG001|Outcome|Mometasone Nasal Spray|"The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray."
11342338|NCT03705793|EG000|Reported Event|Mometasone Furoate Nasal Irrigation|"The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Furoate Nasal Irrigation: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray."
11242231|NCT02493946|FG002|Participant Flow|BTX-A-HAC Solution 50 U - Long Term (LT) Analyses|"Eligible subjects who completed the DB Cycle 1 treatment were able to receive further treatment in the OL period (OL Cycles 2 to 5). Additional BTX-naïve (de novo) subjects were enrolled into the OL period to receive treatment with BTX-A-HAC during OL Cycle 1, and if eligible for retreatment de novo subjects received retreatment in OL Cycles 2 to 5.~Each treatment cycle included a single treatment with 50 U (0.25 mL) BTX-A-HAC administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region, and treatments were separated by at least 12 weeks."
11199082|NCT02183675|FG004|Participant Flow|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
11199083|NCT02183675|FG005|Participant Flow|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
10803640|NCT02948959|EG000|Reported Event|Placebo|Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11199084|NCT02183675|OG000|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
11199085|NCT02183675|OG001|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
10803942|NCT01049035|OG001|Outcome|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11199086|NCT02183675|OG002|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
11199087|NCT02183675|OG001|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
11199088|NCT02183675|EG000|Reported Event|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
11199089|NCT02183675|EG001|Reported Event|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
11199090|NCT02183675|EG002|Reported Event|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
11199091|NCT02183675|EG003|Reported Event|All Patients|"All participants in the study. Participants received three treatments in a randomised order~T80-A5-H12.5~T80-A5~T80-H12.5"
11199092|NCT02183792|BG000|Baseline|Tolvaptan|"Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)~Tolvaptan"
11199093|NCT02183792|BG001|Baseline|Furosemide|"Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)~Furosemide"
11199094|NCT02183792|BG002|Baseline|Total|Total of all reporting groups
11199095|NCT02183792|FG000|Participant Flow|Tolvaptan|"Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)~Tolvaptan"
11199096|NCT02183792|FG001|Participant Flow|Furosemide|"Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)~Furosemide"
11199097|NCT02183792|OG000|Outcome|Tolvaptan|"Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)~Tolvaptan"
11199098|NCT02183792|OG001|Outcome|Furosemide|"Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)~Furosemide"
11199099|NCT02183792|EG000|Reported Event|Tolvaptan|"Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)~Tolvaptan"
11199100|NCT02183792|EG001|Reported Event|Furosemide|"Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)~Furosemide"
11199101|NCT02184143|BG000|Baseline|CBPT Intervention|Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject will receive a binder to follow along with study therapist.
11199102|NCT02184143|BG001|Baseline|Education Intervention|Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject will receive a binder to follow along with study therapist.
11199103|NCT02184143|BG002|Baseline|Total|Total of all reporting groups
11199104|NCT02184143|FG000|Participant Flow|CBPT Intervention|Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject received a binder to follow along with study therapist.
11199105|NCT02184143|FG001|Participant Flow|Education Intervention|Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject received a binder to follow along with study therapist.
11199106|NCT02184143|OG000|Outcome|CBPT Intervention|Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject will receive a binder to follow along with study therapist.
11199107|NCT02184143|OG001|Outcome|Education Intervention|Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject will receive a binder to follow along with study therapist.
11199108|NCT02184143|OG000|Outcome|CBPT Intervention|Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject received a binder to follow along with study therapist.
11199109|NCT02184143|OG001|Outcome|Education Intervention|Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject received a binder to follow along with study therapist.
11199110|NCT02184143|EG000|Reported Event|CBPT Intervention|Subjects participate in the cognitive behavioral physical therapy (CBPT) program focusing on a patient-oriented self-management approach to reduce pain and disability and improve physical activity and function, through reductions in fear of movement and increases in self-efficacy. Program consists of six weekly telephone sessions with a trained physical therapist. The first session is 45 minutes and the remaining 5 sessions are 30 minutes. Each subject received a binder to follow along with study therapist.
11242232|NCT02493946|OG000|Outcome|BTX-A-HAC Solution 50 U - DB Period|"During the DB period, subjects were randomised to receive a single treatment of BTX-A-HAC solution 50 U.~50 U (0.25 mL) BTX-A-HAC was administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive further BTX-A-HAC treatment."
11242233|NCT02493946|OG001|Outcome|Placebo - DB Period|"During the DB period, subjects were randomised to receive a single treatment of placebo. 0.25 mL placebo was administered as five injections of 0.05 mL each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive BTX-A-HAC treatment."
11242234|NCT02493946|OG000|Outcome|BTX-A-HAC Solution 50 U - LT Analyses|"Eligible subjects who completed the DB Cycle 1 treatment were able to receive further treatment in the OL period (OL Cycles 2 to 5). Additional BTX-naïve (de novo) subjects were enrolled into the OL period to receive treatment with BTX-A-HAC during OL Cycle 1, and if eligible for retreatment de novo subjects received retreatment in OL Cycles 2 to 5.~Each treatment cycle included a single treatment with 50 U (0.25 mL) BTX-A-HAC administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region, and treatments were separated by at least 12 weeks."
11242235|NCT02493946|EG000|Reported Event|BTX-A-HAC Solution 50 U - DB Period|"During the DB period, subjects were randomised to receive a single treatment of BTX-A-HAC solution 50 U.~50 U (0.25 mL) BTX-A-HAC was administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive further BTX-A-HAC treatment."
11242236|NCT02493946|EG001|Reported Event|Placebo - DB Period|"During the DB period, subjects were randomised to receive a single treatment of placebo. 0.25 mL placebo was administered as five injections of 0.05 mL each into one of five predefined sites across the glabellar region.~Subjects who completed the DB treatment (Cycle 1) were eligible to continue to the OL period to receive BTX-A-HAC treatment."
11242237|NCT02493946|EG002|Reported Event|BTX-A-HAC Solution 50 U - LT Analyses|"Eligible subjects who completed the DB Cycle 1 treatment were able to receive further treatment in the OL period (OL Cycles 2 to 5). Additional BTX-naïve (de novo) subjects were enrolled into the OL period to receive treatment with BTX-A-HAC during OL Cycle 1, and if eligible for retreatment de novo subjects received retreatment in OL Cycles 2 to 5.~Each treatment cycle included a single treatment with 50 U (0.25 mL) BTX-A-HAC administered as five injections of 10 U (0.05 mL) each into one of five predefined sites across the glabellar region, and treatments were separated by at least 12 weeks."
11242238|NCT02494076|BG000|Baseline|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
11242239|NCT02494076|BG001|Baseline|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
11242240|NCT02494076|BG002|Baseline|Total|Total of all reporting groups
11242241|NCT02494076|FG000|Participant Flow|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
11242242|NCT02494076|FG001|Participant Flow|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
11242243|NCT02494076|OG000|Outcome|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
11242244|NCT02494076|OG001|Outcome|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
11242245|NCT02494076|EG000|Reported Event|EzPAP|"Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.~EzPAP"
11242246|NCT02494076|EG001|Reported Event|Standard Care|"Patients randomized to the control arm will receive first-line therapies and standard therapy.~Standard Care"
11242247|NCT02494102|BG000|Baseline|Placebo|"Administered Placebo day of surgery immediately prior to general anesthesia and surgery~Placebo"
11242248|NCT02494102|BG001|Baseline|Modafinil|"Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery~Modafinil: Atypical Psychomotor stimulant"
11242249|NCT02494102|BG002|Baseline|Total|Total of all reporting groups
11242250|NCT02494102|FG000|Participant Flow|Placebo|"Administered Placebo day of surgery immediately prior to general anesthesia and surgery~Placebo"
11242251|NCT02494102|FG001|Participant Flow|Modafinil|"Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery~Modafinil: Atypical Psychomotor stimulant"
11242252|NCT02494102|OG000|Outcome|Placebo|"Administered Placebo day of surgery immediately prior to general anesthesia and surgery~Placebo"
11242253|NCT02494102|OG001|Outcome|Modafinil|"Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery~Modafinil: Atypical Psychomotor stimulant"
11242254|NCT02494102|EG000|Reported Event|Placebo|"Administered Placebo day of surgery immediately prior to general anesthesia and surgery~Placebo"
11242255|NCT02494102|EG001|Reported Event|Intervention|"Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery~Modafinil: Atypical Psychomotor stimulant"
11242256|NCT02494180|BG000|Baseline|A: Intravenous Fentanyl, Midazolam|"group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval~fentanyl: arm A receiving iv fentanyl~Midazolam: arm A receiving iv midazolam"
11242257|NCT02494180|BG001|Baseline|B: Intravenous Pethidine, Diazepam|"group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval~pethidine: arm B receiving iv pethidine~Diazepam: arm B receiving iv diazepam"
11242258|NCT02494180|BG002|Baseline|Total|Total of all reporting groups
10800243|NCT02243605|FG001|Participant Flow|Osteosarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :~a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).~a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising."
11242259|NCT02494180|FG000|Participant Flow|A: Intravenous Fentanyl, Midazolam|"group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval~fentanyl: arm A receiving iv fentanyl~Midazolam: arm A receiving iv midazolam"
11199111|NCT02184143|EG001|Reported Event|Education Intervention|Subjects participate in an education program focusing on postoperative recovery. Sessions address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, ways to promote healing, stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury. Treatment Group 2 is matched to the Treatment Group 1 in terms of session frequency, length and contact with the study therapist. Each subject received a binder to follow along with study therapist.
11199112|NCT02184169|BG000|Baseline|HLHS|"Patients undergoing palliative repair.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199113|NCT02184169|BG001|Baseline|TGA/IVS|"Surgical repair of TGA.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199114|NCT02184169|BG002|Baseline|Total|Total of all reporting groups
11199115|NCT02184169|FG000|Participant Flow|HLHS|"Patients undergoing palliative repair.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199116|NCT02184169|FG001|Participant Flow|TGA With/Without VSD|"Surgical repair of TGA.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199117|NCT02184169|OG000|Outcome|HLHS|"Patients undergoing palliative repair.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199118|NCT02184169|OG001|Outcome|TGA With/Without VSD|"Surgical repair of TGA.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199119|NCT02184169|OG000|Outcome|Hypoplastic Left Heart Syndrome|"Patients undergoing palliative repair.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199120|NCT02184169|OG001|Outcome|Transposition of the Great Arteries|"Surgical repair of TGA.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199121|NCT02184169|EG000|Reported Event|HLHS|"Patients undergoing palliative repair.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199122|NCT02184169|EG001|Reported Event|TGA/IVS|"Surgical repair of TGA.~General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements~Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system"
11199123|NCT02184208|BG000|Baseline|Patient Categorization|We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
11242260|NCT02494180|FG001|Participant Flow|B: Intravenous Pethidine, Diazepam|"group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval~pethidine: arm B receiving iv pethidine~Diazepam: arm B receiving iv diazepam"
11199124|NCT02184208|FG000|Participant Flow|Patient Categorization|We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
11199125|NCT02184208|OG000|Outcome|Device Utlization Following Extubation|The ERT score predicted device utilization
11199126|NCT02184208|OG001|Outcome|Pulmonary Mechanics|Heart rate (HR), respiratory rate (RR), spontaneous respiratory rate (Spont. RR) and modified ventilation index (MVI) subcategory.
11199127|NCT02184208|EG000|Reported Event|Device Utlization Following Extubation|Patients who were extubated were evaluated.
11199128|NCT02184208|EG001|Reported Event|Pulmonary Mechanics|All patients on mechanical ventilation were evaluated.
11199129|NCT02184442|BG000|Baseline|TAVR - SAPIEN XT|"TAVR (transaortic valve replacement) with SAPIEN XT~TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199130|NCT02184442|BG001|Baseline|TAVR - SAPIEN|"TAVR (transaortic valve replacement) with SAPIEN is the control arm~TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199131|NCT02184442|BG002|Baseline|Total|Total of all reporting groups
11199132|NCT02184442|FG000|Participant Flow|TAVR - SAPIEN XT|"TAVR (transaortic valve replacement) with SAPIEN XT~TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199133|NCT02184442|FG001|Participant Flow|TAVR - SAPIEN|"TAVR (transaortic valve replacement) with SAPIEN is the control arm~TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199134|NCT02184442|OG000|Outcome|TAVR - SAPIEN XT|"TAVR (transaortic valve replacement) with SAPIEN XT~TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199135|NCT02184442|OG001|Outcome|TAVR - SAPIEN|"TAVR (transaortic valve replacement) with SAPIEN is the control arm~TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199136|NCT02184442|EG000|Reported Event|TAVR - SAPIEN XT|"TAVR (transaortic valve replacement) with SAPIEN XT~TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11199137|NCT02184442|EG001|Reported Event|TAVR - SAPIEN|"TAVR (transaortic valve replacement) with SAPIEN is the control arm~TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement"
11202347|NCT02207244|FG006|Participant Flow|Placebo Then Guselkumab 100 mg (Week 28 - 264)|Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
10966089|NCT00885534|BG000|Baseline|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
10966090|NCT00885534|FG000|Participant Flow|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
11199138|NCT02184455|BG000|Baseline|DermGEN Decellularized Dermal Matrix|"DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.~DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue."
11199139|NCT02184455|FG000|Participant Flow|DermGEN Decellularized Dermal Matrix|"DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.~DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue."
10803943|NCT01049035|OG004|Outcome|Group 5: MenACYW Conjugate Vaccine: 12 Months|Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
11199140|NCT02184455|OG000|Outcome|DermGEN Decellularized Dermal Matrix|"DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.~DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue."
11199141|NCT02184455|EG000|Reported Event|DermGEN Decellularized Dermal Matrix|"DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.~DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue."
11199142|NCT02184494|BG000|Baseline|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199143|NCT02184494|BG001|Baseline|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199144|NCT02184494|BG002|Baseline|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199145|NCT02184494|BG003|Baseline|Total|Total of all reporting groups
11199146|NCT02184494|FG000|Participant Flow|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199147|NCT02184494|FG001|Participant Flow|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199148|NCT02184494|FG002|Participant Flow|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199149|NCT02184494|OG000|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199150|NCT02184494|OG001|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199151|NCT02184494|OG002|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199152|NCT02184494|EG000|Reported Event|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199153|NCT02184494|EG001|Reported Event|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199154|NCT02184494|EG002|Reported Event|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
11199155|NCT02184572|BG000|Baseline|INV_MMR|Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199156|NCT02184572|BG001|Baseline|COM_MMR|Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199157|NCT02184572|BG002|Baseline|Total|Total of all reporting groups
11199158|NCT02184572|FG000|Participant Flow|INV_MMR|Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199159|NCT02184572|FG001|Participant Flow|COM_MMR|Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199160|NCT02184572|OG000|Outcome|INV_MMR Group|Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199161|NCT02184572|OG001|Outcome|COM_MMR Group|Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199162|NCT02184572|OG000|Outcome|INV_MMR|Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199163|NCT02184572|OG001|Outcome|COM_MMR|Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199164|NCT02184572|EG000|Reported Event|INV_MMR Group|Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199165|NCT02184572|EG001|Reported Event|COM_MMR Group|Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
11199166|NCT02184611|BG000|Baseline|Placebo|Participants received matching placebo to UMEC via ELLIPTA® novel DPI once daily in the morning for the 24-week treatment period.
11199167|NCT02184611|BG001|Baseline|UMEC 62.5 mcg|Participants received UMEC 62.5 mcg via ELLIPTA® DPI once daily in the morning for the 24-week treatment period.
11199168|NCT02184611|BG002|Baseline|Total|Total of all reporting groups
11199169|NCT02184611|FG000|Participant Flow|Placebo|Participants received matching placebo to umeclidinium (UMEC) via ELLIPTA® novel dry powder inhaler (DPI) once daily in the morning for the 24-week treatment period.
11199170|NCT02184611|FG001|Participant Flow|UMEC 62.5 mcg|Participants received UMEC 62.5 micrograms (mcg) via ELLIPTA® DPI once daily in the morning for the 24-week treatment period.
11199171|NCT02184611|OG000|Outcome|Placebo|Participants received matching placebo to UMEC via ELLIPTA® novel DPI once daily in the morning for the 24-week treatment period.
11199172|NCT02184611|OG001|Outcome|UMEC 62.5 mcg|Participants received UMEC 62.5 mcg via ELLIPTA® DPI once daily in the morning for the 24-week treatment period.
11199173|NCT02184611|EG000|Reported Event|Placebo|Participants received matching placebo to UMEC via ELLIPTA® novel DPI once daily in the morning for the 24-week treatment period.
11199174|NCT02184611|EG001|Reported Event|UMEC 62.5 mcg|Participants received UMEC 62.5 mcg via ELLIPTA® DPI once daily in the morning for the 24-week treatment period.
11199175|NCT02184624|BG000|Baseline|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199176|NCT02184624|BG001|Baseline|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199177|NCT02184624|BG002|Baseline|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199178|NCT02184624|BG003|Baseline|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199179|NCT02184624|BG004|Baseline|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199180|NCT02184624|BG005|Baseline|Total|Total of all reporting groups
11199181|NCT02184624|FG000|Participant Flow|Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.
11199182|NCT02184624|FG001|Participant Flow|Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199183|NCT02184624|FG002|Participant Flow|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199184|NCT02184624|FG003|Participant Flow|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199185|NCT02184624|FG004|Participant Flow|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199186|NCT02184624|OG000|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199187|NCT02184624|OG001|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199188|NCT02184624|OG002|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199189|NCT02184624|OG003|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199190|NCT02184624|OG004|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
10803944|NCT01049035|OG005|Outcome|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11199191|NCT02184624|EG000|Reported Event|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199192|NCT02184624|EG001|Reported Event|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11242261|NCT02494180|OG000|Outcome|A: Intravenous Fentanyl, Midazolam|"group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval~fentanyl: arm A receiving iv fentanyl~Midazolam: arm A receiving iv midazolam"
11242262|NCT02494180|OG001|Outcome|B: Intravenous Pethidine, Diazepam|"group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval~pethidine: arm B receiving iv pethidine~Diazepam: arm B receiving iv diazepam"
11199193|NCT02184624|EG002|Reported Event|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199194|NCT02184624|EG003|Reported Event|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
10803945|NCT01049035|OG006|Outcome|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11199195|NCT02184624|EG004|Reported Event|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
11199196|NCT02184988|BG000|Baseline|Botulinum Neurotoxin, Type A|"DWP-450 (Botulinum purified neurotoxin, Type A) Injection~Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml."
11242263|NCT02494180|EG000|Reported Event|A: Intravenous Fentanyl, Midazolam|"group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval~fentanyl: arm A receiving iv fentanyl~Midazolam: arm A receiving iv midazolam"
11242264|NCT02494180|EG001|Reported Event|B: Intravenous Pethidine, Diazepam|"group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval~pethidine: arm B receiving iv pethidine~Diazepam: arm B receiving iv diazepam"
11242265|NCT02494297|BG000|Baseline|Cyproterone Acetate and Ethinyl Estradiol|Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
11199197|NCT02184988|FG000|Participant Flow|Botulinum Neurotoxin, Type A|"DWP-450 (Botulinum purified neurotoxin, Type A) Injection~Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml."
11199198|NCT02184988|OG000|Outcome|Botulinum Neurotoxin, Type A|"DWP-450 (Botulinum purified neurotoxin, Type A) Injection~Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml."
11199199|NCT02184988|EG000|Reported Event|Botulinum Neurotoxin, Type A|"DWP-450 (Botulinum purified neurotoxin, Type A) Injection~Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml."
11199200|NCT02185014|BG000|Baseline|Adalimumab|Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
11199201|NCT02185014|FG000|Participant Flow|Adalimumab|Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
11199202|NCT02185014|OG000|Outcome|Adalimumab|Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
11199203|NCT02185014|EG000|Reported Event|Adalimumab|Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
11199204|NCT02185040|BG000|Baseline|Part 1: Placebo|Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
11199205|NCT02185040|BG001|Baseline|Part 1: Iberdomide 0.3 mg QOD|Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
11199206|NCT02185040|BG002|Baseline|Part 1: Iberdomide 0.3 mg QD|Participants received 0.3 mg iberdomide capsules QD up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules QD during ATEP up to 2 years.
11242266|NCT02494297|FG000|Participant Flow|Cyproterone Acetate and Ethinyl Estradiol|Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
11242267|NCT02494297|OG000|Outcome|Cyproterone Acetate and Ethinyl Estradiol|Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
11199207|NCT02185040|BG003|Baseline|Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants received iberdomide 0.6 mg capsules on alternating (ALT) days with 0.3 mg iberdomide capsules on alternating days up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days during the ATEP up to 2 years.
11199208|NCT02185040|BG004|Baseline|Part 1: Iberdomide 0.6 mg QD|Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
11199209|NCT02185040|BG005|Baseline|Total|Total of all reporting groups
11199210|NCT02185040|FG000|Participant Flow|Part 1: Placebo|Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
11199211|NCT02185040|FG001|Participant Flow|Part 1: Iberdomide 0.3 mg QOD|Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
11199212|NCT02185040|FG002|Participant Flow|Part 1: Iberdomide 0.3 mg QD|Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
11199213|NCT02185040|FG003|Participant Flow|Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
11199214|NCT02185040|FG004|Participant Flow|Part 1: Iberdomide 0.6 mg QD|Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
11199215|NCT02185040|FG005|Participant Flow|ATEP: Iberdomide 0.3 mg QD|Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
11199216|NCT02185040|FG006|Participant Flow|ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
11199217|NCT02185040|OG000|Outcome|Part 1: Placebo|Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
11199218|NCT02185040|OG001|Outcome|Part 1: Iberdomide 0.3 mg QOD|Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
11199219|NCT02185040|OG002|Outcome|Part 1: Iberdomide 0.3 mg QD|Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.
11199220|NCT02185040|OG003|Outcome|Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
11199221|NCT02185040|OG004|Outcome|Part 1: Iberdomide 0.6 mg QD|Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
11199222|NCT02185040|OG000|Outcome|ATEP: Iberdomide 0.3 mg QD|Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
11199223|NCT02185040|OG001|Outcome|ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
11199224|NCT02185040|OG000|Outcome|Part 1: Iberdomide 0.3 mg QOD|Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
11199225|NCT02185040|OG001|Outcome|Part 1: Iberdomide 0.3 mg QD|Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.
11199226|NCT02185040|OG002|Outcome|Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days|Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.
11199227|NCT02185040|OG003|Outcome|Part 1: Iberdomide 0.6 mg QD|Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
11199228|NCT02185040|EG000|Reported Event|Part 1: Placebo|Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
11199229|NCT02185040|EG001|Reported Event|Part 1: Iberdomide 0.3 mg QOD|Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
11199230|NCT02185040|EG002|Reported Event|Part 1: Iberdomide 0.3 mg QD|Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.
11199231|NCT02185040|EG003|Reported Event|Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD|Participants received iberdomide 0.6 mg and 0.3 mg on alternating days for up to 84 days during the Part 1 treatment phase.
11199232|NCT02185040|EG004|Reported Event|Part 1: Iberdomide 0.6 mg QD|Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
11199233|NCT02185040|EG005|Reported Event|ATEP: Iberdomide 0.3 mg QD|Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
11199234|NCT02185040|EG006|Reported Event|ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD|Participants originally randomized to iberdomide 0.6 mg capsules QD or 0.6 mg Iberdomide capsules alternating days with 0.3 mg iberdomide capsules or placebo capsules QD chorts (in these respective groups), during the Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days when entered into the active treatment extension phase up to 2 years.
11199235|NCT02185053|BG000|Baseline|Safety Population|All subjects who received at least one dose of any study drug.
11199236|NCT02185053|FG000|Participant Flow|Solifenacin Dose Escalation|Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)
11199237|NCT02185053|FG001|Participant Flow|Donepezil Dose Escalation|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
11199238|NCT02185053|FG002|Participant Flow|Donepezil Dose Maintenance|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
11199239|NCT02185053|OG000|Outcome|Donepezil Dose Escalation|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
11199240|NCT02185053|OG001|Outcome|Donepezil Dose Maintenance|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
11199241|NCT02185053|OG000|Outcome|Safety Population|All subjects who received at least one dose of any study drug.
11199242|NCT02185053|OG000|Outcome|Solifenain Dose Escalation|Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day)
11199243|NCT02185053|OG001|Outcome|Donepezil Dose Escalation|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase.
11199244|NCT02185053|OG002|Outcome|Donepezil Dose Maintenance|Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase.
11199245|NCT02185053|EG000|Reported Event|Safety Population|All subjects who received at least one dose of any study drug.
11199246|NCT02185105|BG000|Baseline|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199247|NCT02185105|FG000|Participant Flow|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199248|NCT02185105|OG000|Outcome|Comfilcon A XR (Extended Range) Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199249|NCT02185105|OG001|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199250|NCT02185105|OG000|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199251|NCT02185105|OG000|Outcome|Comfilcon A XR Toric (Extended Range)|
11199252|NCT02185105|OG001|Outcome|Comfilcon A Toric|
11242268|NCT02494297|EG000|Reported Event|Cyproterone Acetate and Ethinyl Estradiol|Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
11199253|NCT02185105|OG002|Outcome|No Preference|
11199254|NCT02185105|OG000|Outcome|Comflicon A XR Toric (Extended Range)|
11199255|NCT02185105|EG000|Reported Event|Comfilcon A MTO|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199256|NCT02185105|EG001|Reported Event|Comfilcon A|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair."
11199257|NCT02185131|BG000|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199258|NCT02185131|BG001|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199259|NCT02185131|BG002|Baseline|Total|Total of all reporting groups
11242269|NCT02494323|BG000|Baseline|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
11242270|NCT02494323|FG000|Participant Flow|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
11242271|NCT02494323|OG000|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10803641|NCT02948959|EG001|Reported Event|Dupilumab|Dupilumab 200 mg (in 1.14 mL for >30 kg BW) or 100 mg (in 0.67 mL for <=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
11242272|NCT02494323|EG000|Reported Event|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10803946|NCT01049035|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
11243315|NCT02502149|OG001|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for pharmacokinetic assessment 2 (PK2). Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at Pharmacokinetic assessment 3 (PK3) at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11199260|NCT02185131|FG000|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199261|NCT02185131|FG001|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199262|NCT02185131|OG000|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199263|NCT02185131|OG001|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199264|NCT02185131|EG000|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
10803947|NCT01049035|EG001|Reported Event|Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
11243316|NCT02502149|OG000|Outcome|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
11342370|NCT03706313|OG000|Outcome|Genicular Nerve Block With Bupivacaine and Dexamethasone|The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.
11342371|NCT03706313|OG001|Outcome|Genicular Nerve Block With Saline|The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
11342372|NCT03706313|EG000|Reported Event|Genicular Nerve Block With Bupivacaine and Dexamethasone|The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.
11342373|NCT03706313|EG001|Reported Event|Genicular Nerve Block With Saline|The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
11342374|NCT03706456|BG000|Baseline|Darvadstrocel 24 mL|Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1.
11342375|NCT03706456|FG000|Participant Flow|Darvadstrocel 24 mL|Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1.
11342376|NCT03706456|OG000|Outcome|Darvadstrocel 24 mL|Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1.
11342377|NCT03706456|EG000|Reported Event|Darvadstrocel 24 mL|Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1.
11342378|NCT03706469|BG000|Baseline|Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)|TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342379|NCT03706469|BG001|Baseline|Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)|TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342380|NCT03706469|BG002|Baseline|Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)|TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342381|NCT03706469|BG003|Baseline|Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)|TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342382|NCT03706469|BG004|Baseline|Total|Total of all reporting groups
11342383|NCT03706469|FG000|Participant Flow|Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)|TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342488|NCT03708393|FG000|Participant Flow|Overall (Subjects Randomly Selected From PIONEER-01 Study)|Each subject in all 3 cohorts had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. All subjects for all 3 cohorts were included in safety analysis. All subjects for all 3 cohorts were followed and completed in the same manner. Cohort 1 (n=120 was representative of the subject population for the primary analysis, Cohort 2 (n=30) was special population for internal study of FN's and Cohort 3 (n=5) was for internal study of DCIS masses.
11342489|NCT03708393|OG000|Outcome|IUS Alone|IUS alone imaging
11342490|NCT03708393|OG001|Outcome|Imagio (IUS+OA)|IUS+OA imaging
11342491|NCT03708393|OG000|Outcome|Imagio IUS|"Read 1 - Mammo (as available) + Imagio Ultrasound~Imagio Ultrasound: Imagio ultrasound images to be reviewed as part of the reader study~Mammography: Mammography images as available per standard of care"
11342492|NCT03708393|OG001|Outcome|Imagio (IUS+OA)|"Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)~Imagio (IUS+OA): The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study~Mammography: Mammography images as available per standard of care"
11342493|NCT03708393|OG000|Outcome|IUS Alone|Results for IUS alone readings
11342494|NCT03708393|OG001|Outcome|Imagio (IUS+OA)|"IUS+OA imaging~Results for Imagio readings"
11342495|NCT03708393|EG000|Reported Event|Overall (Masses Randomly Selected From PIONEER-01 Study)|Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.
11342496|NCT03708562|BG000|Baseline|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11342497|NCT03708562|FG000|Participant Flow|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11342498|NCT03708562|OG000|Outcome|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11342499|NCT03708562|EG000|Reported Event|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11342500|NCT03708744|BG000|Baseline|Entire Study Population|"Each subject received each of the four treatments below in one of four treatment sequences.~A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg"
11342501|NCT03708744|FG000|Participant Flow|ABCD|A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg
11342502|NCT03708744|FG001|Participant Flow|BDAC|B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) D: Intranasal zolmitriptan 2.5 mg A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
11342503|NCT03708744|FG002|Participant Flow|CADB|C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
11342504|NCT03708744|FG003|Participant Flow|DCBA|D: Intranasal zolmitriptan 2.5 mg C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
11342505|NCT03708744|OG000|Outcome|Treatment A|"Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)~A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)"
11342506|NCT03708744|OG001|Outcome|Treatment B|"Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)~B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)"
11342507|NCT03708744|OG002|Outcome|Treatment C|"Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)~C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)"
11342508|NCT03708744|OG003|Outcome|Treatment D|"Treatment D: Intranasal zolmitriptan 2.5 mg~D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan"
11342509|NCT03708744|EG000|Reported Event|Treatment A|"Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)~A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)"
11342510|NCT03708744|EG001|Reported Event|Treatment B|"Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)~B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)"
11342511|NCT03708744|EG002|Reported Event|Treatment C|"Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)~C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)"
11342512|NCT03708744|EG003|Reported Event|Treatment D|"Treatment D: Intranasal zolmitriptan 2.5 mg~D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan"
11342513|NCT03708770|BG000|Baseline|endoAVF|everlinQ endoAVF System
11342514|NCT03708770|FG000|Participant Flow|endoAVF|everlinQ arteriovenous fistula (endoAVF) System
11342515|NCT03708770|OG000|Outcome|endoAVF|everlinQ arteriovenous fistula (endoAVF) System
11342516|NCT03708770|EG000|Reported Event|endoAVF|everlinQ arteriovenous fistula (endoAVF) System
11342517|NCT03709602|BG000|Baseline|Adolescents Ages 11 to 14 Years|Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who did not receive two vaccine doses). Qualitative sample.
11342518|NCT03709602|BG001|Baseline|Parent of Adolescents|Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample.
11342519|NCT03709602|BG002|Baseline|Cohort of Adolescents From Electronic Health Record (EHR)|A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample.
11342520|NCT03709602|BG003|Baseline|Total|Total of all reporting groups
11342521|NCT03709602|FG000|Participant Flow|Adolescents Ages 11 to 14 Years|Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who received only one vaccine dose within 14-month period). Qualitative sample.
11342522|NCT03709602|FG001|Participant Flow|Parent of Adolescents|Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample.
11342523|NCT03709602|FG002|Participant Flow|Cohort of Adolescents From Electronic Health Record (EHR)|A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample.
11342524|NCT03709602|OG000|Outcome|Cohort of Adolescents From Electronic Health Record (EHR)|A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period.
11342525|NCT03709602|OG000|Outcome|Cohort of Adolescents From EHR|A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period.
11342526|NCT03709602|EG000|Reported Event|Adolescents Ages 11 to 14 Years|Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who did not receive two vaccine doses).
11342527|NCT03709602|EG001|Reported Event|Parent of Adolescents|Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status.
11342528|NCT03709654|BG000|Baseline|Treatment Arm|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.~NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01"
11342529|NCT03709654|BG001|Baseline|Vehicle Control|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.~Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control"
11342530|NCT03709654|BG002|Baseline|Total|Total of all reporting groups
11342531|NCT03709654|FG000|Participant Flow|Treatment Arm|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.~NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01"
11342532|NCT03709654|FG001|Participant Flow|Vehicle Control|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.~Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control"
11342533|NCT03709654|OG000|Outcome|Treatment Arm|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.~NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01"
11342534|NCT03709654|OG001|Outcome|Vehicle Control|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.~Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control"
11342535|NCT03709654|EG000|Reported Event|Treatment Arm|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.~NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01"
11342536|NCT03709654|EG001|Reported Event|Vehicle Control|"Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.~Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control"
11342537|NCT03709810|BG000|Baseline|Overall|Included participants randomized in both the treatment arms
11342538|NCT03709810|FG000|Participant Flow|Sequence 1|Participants received interventions in a crossover manner: A (experimental denture adhesive) in period 1, then intervention B (no adhesive) in period 2.
11342539|NCT03709810|FG001|Participant Flow|Sequence 2|Participants received interventions in a crossover manner: B (no adhesive) in period 1, then intervention A (experimental denture adhesive) in period 2.
11342540|NCT03709810|OG000|Outcome|Experimental Denture Adhesive|Participants randomized in this arm received 1.6 grams (g) of adhesive which was applied as 1.0 g (+/-0.1 g) on maxillary denture and 0.6 g (+/-0.1 g) on mandibular denture by dispensing staff. The adhesive was applied to upper and lower denture using a continuous strip pattern which was then placed in mouth for 60+/-5 min.
11342541|NCT03709810|OG001|Outcome|No Adhesive|Participants did not receive any denture adhesive treatment randomized in this arm.
11342542|NCT03709810|EG000|Reported Event|Experimental Denture Adhesive|Participants randomized in this arm received 1.6 grams (g) of adhesive which was applied as 1.0 g (+/-0.1 g) on maxillary denture and 0.6 g (+/-0.1 g) on mandibular denture by dispensing staff. The adhesive was applied to upper and lower denture using a continuous strip pattern which was then placed in mouth for 60+/-5 min.
11342543|NCT03709810|EG001|Reported Event|No Adhesive|Participants did not receive any denture adhesive treatment randomized in this arm.
11342544|NCT03709823|BG000|Baseline|1.5 mg Cytisine, Commercial Schedule|1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342545|NCT03709823|BG001|Baseline|3.0 mg Cytisine, Commercial Schedule|3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342546|NCT03709823|BG002|Baseline|Placebo, Commercial Schedule|Placebo tablets using the commercial 25-day titration schedule + behavioral support
11342547|NCT03709823|BG003|Baseline|1.5 mg Cytisine, TID Schedule|1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342548|NCT03709823|BG004|Baseline|3.0 mg Cytisine, TID Schedule|3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342549|NCT03709823|BG005|Baseline|Placebo, TID Schedule|Placebo tablets for 25 days using a simplified TID schedule + behavioral support
11342550|NCT03709823|BG006|Baseline|Total|Total of all reporting groups
11342551|NCT03709823|FG000|Participant Flow|1.5 mg Cytisine, Commercial Schedule|1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342552|NCT03709823|FG001|Participant Flow|3.0 mg Cytisine, Commercial Schedule|3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342553|NCT03709823|FG002|Participant Flow|Placebo, Commercial Schedule|Placebo tablets using the commercial 25-day titration schedule + behavioral support
11342554|NCT03709823|FG003|Participant Flow|1.5 mg Cytisine, TID Schedule|1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support
11342555|NCT03709823|FG004|Participant Flow|3.0 mg Cytisine, TID Schedule|3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342556|NCT03709823|FG005|Participant Flow|Placebo, TID Schedule|Placebo tablets for 25 days using a simplified TID schedule + behavioral support
11342557|NCT03709823|OG000|Outcome|1.5 mg Cytisine, Commercial Schedule|1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342558|NCT03709823|OG001|Outcome|3.0 mg Cytisine, Commercial Schedule|3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342559|NCT03709823|OG002|Outcome|Placebo, Commercial Schedule|Placebo tablets using the commercial 25-day titration schedule + behavioral support
11342560|NCT03709823|OG003|Outcome|1.5 mg Cytisine, TID Schedule|1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342561|NCT03709823|OG004|Outcome|3.0 mg Cytisine, TID Schedule|3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342562|NCT03709823|OG005|Outcome|Placebo, TID Schedule|Placebo tablets for 25 days using a simplified TID schedule + behavioral support
11342563|NCT03709823|OG002|Outcome|Pooled Placebo|Placebo tablets using the commercial 25-day titration schedule + behavioral support pooled with Placebo tablets for 25 days using a simplified TID schedule + behavioral support
11342564|NCT03709823|OG000|Outcome|1.5 mg Cytisine, TID Schedule|1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342565|NCT03709823|OG001|Outcome|3.0 mg Cytisine, TID Schedule|3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342566|NCT03709823|EG000|Reported Event|1.5 mg Cytisine, Commercial Schedule|1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342567|NCT03709823|EG001|Reported Event|3.0 mg Cytisine, Commercial Schedule|3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
11342568|NCT03709823|EG002|Reported Event|Placebo, Commercial Schedule|Placebo tablets using the commercial 25-day titration schedule + behavioral support
11342569|NCT03709823|EG003|Reported Event|1.5 mg Cytisine, TID Schedule|1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342570|NCT03709823|EG004|Reported Event|3.0 mg Cytisine, TID Schedule|3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
11342571|NCT03709823|EG005|Reported Event|Placebo, TID Schedule|Placebo tablets for 25 days using a simplified TID schedule + behavioral support
11342572|NCT03710083|BG000|Baseline|Study Arm|"Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7).~Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days."
11342573|NCT03710083|FG000|Participant Flow|Study Arm|"Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7).~Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days."
11199265|NCT02185131|EG001|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11199266|NCT02185183|BG000|Baseline|AlequelTM|"AlequelTM~Alequel: Alequel"
11199267|NCT02185183|FG000|Participant Flow|AlequelTM 30 ng Once a Day Orally|"AlequelTM 30 ng once a day orally~Alequel: Alequel"
11199268|NCT02185183|OG000|Outcome|AlequelTM|"AlequelTM~Alequel: Alequel"
11199269|NCT02185183|EG000|Reported Event|AlequelTM|"AlequelTM~Alequel: Alequel"
11342407|NCT03707041|FG004|Participant Flow|P218 100 mg (Oral Capsules) - Cohort 3|"One administration of 100 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 100 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (100 mg) Oral Capsules: 100 mg P218 (2 x 50 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342408|NCT03707041|FG005|Participant Flow|P218 Placebo Oral Capsule - Cohort 3|"One administration of P218 placebo (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of P218 placebo (capsules p.o.), 48 hours after first administration.~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342409|NCT03707041|OG000|Outcome|P218 1000 mg (Oral Capsules) - Cohort 1|"Two administrations of 1000 mg P218 (capsules p.o.), 48 hours apart~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)"
11342410|NCT03707041|OG001|Outcome|P218 Placebo Oral Capsules - Cohort 1|"Two administrations of P218 placebo (capsules p.o.), 48 hours apart~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste"
11342411|NCT03707041|OG000|Outcome|P218 1000 mg (Oral Capsules) - Cohort 2|"One administration of 1000 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 1000 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342412|NCT03707041|OG001|Outcome|P218 100 mg (Oral Capsules) - Cohort 3|"One administration of 100 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 100 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (100 mg) Oral Capsules: 100 mg P218 (2 x 50 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342413|NCT03707041|OG002|Outcome|P218 Placebo Oral Capsule - Cohorts 2 and 3|"One administration of P218 placebo (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of P218 placebo (capsules p.o.), 48 hours after first administration.~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342414|NCT03707041|OG001|Outcome|P218 1000 mg (Oral Capsules) - Cohort 2|"One administration of 1000 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 1000 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342415|NCT03707041|OG002|Outcome|P218 100 mg (Oral Capsules) - Cohort 3|"One administration of 100 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 100 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (100 mg) Oral Capsules: 100 mg P218 (2 x 50 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342416|NCT03707041|OG000|Outcome|P218 1000 mg - Cohort 1|"Two administrations of 1000 mg P218 (capsules p.o.), 48 hours apart~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)"
11342417|NCT03707041|EG000|Reported Event|P218 1000 mg - Cohort 1|"Two administrations of 1000 mg P218 (capsules p.o.), 48 hours apart~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)"
11342418|NCT03707041|EG001|Reported Event|P218 Placebo - Cohort 1|"Two administrations of P218 placebo (capsules p.o.), 48 hours apart~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste"
11342419|NCT03707041|EG002|Reported Event|P218 1000 mg - Challenge - Cohort 2|"One administration of 1000 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 1000 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342420|NCT03707041|EG003|Reported Event|P218 100 mg - Challenge - Cohort 3|"One administration of 100 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 100 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (100 mg) Oral Capsules: 100 mg P218 (2 x 50 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342421|NCT03707041|EG004|Reported Event|P218 Placebo - Challenge - Cohorts 2 and 3|"One administration of P218 placebo (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of P218 placebo (capsules p.o.), 48 hours after first administration.~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342422|NCT03707522|BG000|Baseline|Growth Mindset + MRF Information|"Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes~Growth mindset: 10 minute interactive article describing neuroplasticity~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety"
11342423|NCT03707522|BG001|Baseline|Control + MRF Information|"Online daily activity scheduling interactive article (control) followed by equal length interactive article describing the relationship between modifiable risk factors and mental health outcomes~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety~Control: 10 minute interactive article describing activity scheduling"
11342424|NCT03707522|BG002|Baseline|Control + Growth Mindset|"Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)~Growth mindset: 10 minute interactive article describing neuroplasticity~Control: 10 minute interactive article describing activity scheduling"
11342425|NCT03707522|BG003|Baseline|Control + Control|"2 doses online daily activity scheduling interactive article (control)~Control: 10 minute interactive article describing activity scheduling"
11342426|NCT03707522|BG004|Baseline|Total|Total of all reporting groups
11342427|NCT03707522|FG000|Participant Flow|Growth Mindset + MRF Information|"Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes~Growth mindset: 10 minute interactive article describing neuroplasticity~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety"
11242273|NCT02494336|BG000|Baseline|Trans-incisional Rectus Sheath Block|"rectus sheath block under direct visualization through the umbilical incision by the attending surgeon~Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11242274|NCT02494336|BG001|Baseline|Laparoscopic Guided Rectus Sheath Block|"rectus sheath block under direct laparoscopic visualization by the attending surgeon~Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11242275|NCT02494336|BG002|Baseline|Total|Total of all reporting groups
10803948|NCT01049035|EG002|Reported Event|Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months|Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
11199270|NCT02185339|BG000|Baseline|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199271|NCT02185339|BG001|Baseline|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11338704|NCT03615534|EG003|Reported Event|Combination Therapy|"Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.~Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.~Fenofibrate~Wax Matrix Extended Release Niacin (WMER Niacin)"
11199272|NCT02185339|BG002|Baseline|Total|Total of all reporting groups
11338705|NCT03615807|BG000|Baseline|Short Antibiotic Arm|"10 days for soft tissue infections 3 weeks for osteomyelitis~Surgical debridement (if needed): Surgical debridement~Microbiological sampling: Microbiological sampling~Revascularisation (if needed).: Revascularisation (if needed).~Off-loading: Off-loading by Special shoes~Patient's education and instructions: Patient's education and instructions by specialized nurses~Wound debridement: Regular wound debridement by specialized nurses~Antibiotic duration: Systemic antibiotic duration according to the study arms"
11338706|NCT03615807|BG001|Baseline|Standard Antibiotic Arm|"20 days for soft tissue infections 6 weeks for osteomyelitis~Surgical debridement (if needed): Surgical debridement~Microbiological sampling: Microbiological sampling~Revascularisation (if needed).: Revascularisation (if needed).~Off-loading: Off-loading by Special shoes~Patient's education and instructions: Patient's education and instructions by specialized nurses~Wound debridement: Regular wound debridement by specialized nurses~Antibiotic duration: Systemic antibiotic duration according to the study arms"
11338707|NCT03615807|BG002|Baseline|Total|Total of all reporting groups
11338708|NCT03615807|FG000|Participant Flow|Short Antibiotic Arm|"10 days for soft tissue infections 3 weeks for osteomyelitis~Surgical debridement (if needed): Surgical debridement~Microbiological sampling: Microbiological sampling~Revascularisation (if needed).: Revascularisation (if needed).~Off-loading: Off-loading by Special shoes~Patient's education and instructions: Patient's education and instructions by specialized nurses~Wound debridement: Regular wound debridement by specialized nurses~Antibiotic duration: Systemic antibiotic duration according to the study arms"
11338709|NCT03615807|FG001|Participant Flow|Standard Antibiotic Arm|"20 days for soft tissue infections 6 weeks for osteomyelitis~Surgical debridement (if needed): Surgical debridement~Microbiological sampling: Microbiological sampling~Revascularisation (if needed).: Revascularisation (if needed).~Off-loading: Off-loading by Special shoes~Patient's education and instructions: Patient's education and instructions by specialized nurses~Wound debridement: Regular wound debridement by specialized nurses~Antibiotic duration: Systemic antibiotic duration according to the study arms"
11338710|NCT03615807|OG000|Outcome|Short Antibiotic Arm|For soft tissue infection: 10 days of systemic antibiotics For osteomyelitis: 3 weeks
11338711|NCT03615807|OG001|Outcome|Long Antibiotic Arm|For soft tissue infections: 20 days For osteomyelitis: 6 weeks
11338712|NCT03615807|EG000|Reported Event|Short Antibiotic Arm|10 days antibiotic for soft tissue infections 3 weeks antibiotic for osteomyelitis
11338713|NCT03615807|EG001|Reported Event|Long Antibiotic Arm|20 days antibiotic for soft tissue infections 6 weeks antibiotic for osteomyelitis
11338714|NCT03615911|BG000|Baseline|Vaccination With 10^7 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.~vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes"
11338715|NCT03615911|BG001|Baseline|Vaccination With 10^8 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.~vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes"
11338716|NCT03615911|BG002|Baseline|Total|Total of all reporting groups
11338717|NCT03615911|FG000|Participant Flow|Vaccination With 10^7 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.~vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes"
11338718|NCT03615911|FG001|Participant Flow|Vaccination With 10^8 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.~vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes"
11338719|NCT03615911|OG000|Outcome|Vaccination With 10^7 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28.~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338720|NCT03615911|OG001|Outcome|Vaccination With 10^8 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28.~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338721|NCT03615911|OG000|Outcome|Vaccination With 10^7 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338722|NCT03615911|OG001|Outcome|Vaccination With 10^8 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338723|NCT03615911|EG000|Reported Event|Vaccination With 10^7 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28.~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338724|NCT03615911|EG001|Reported Event|Vaccination With 10^8 PFU MVA-MERS-S|"Vaccinations occur on days 0 and 28.~A subgroup will additionally receive a late booster immunization with 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization."
11338725|NCT03615924|BG000|Baseline|Ticagrelor 15/30/45 mg bd|"Pediatric participants received ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The dose of ticagrelor was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of ticagrelor 15 mg (1x15 mg) bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of ticagrelor 15 mg (2x15 mg) bd.~Participants with a body weight >48 kg received 3 tablets of ticagrelor 15 mg (3x15 mg) bd."
11338726|NCT03615924|BG001|Baseline|Placebo|"Pediatric participants received placebo matching with ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The number of placebo tablets was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of placebo matching with ticagrelor 15 mg bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of placebo matching with ticagrelor 30 mg bd.~Participants with a body weight >48 kg received 3 tablets of placebo matching with ticagrelor 45 mg bd."
11338727|NCT03615924|BG002|Baseline|Total|Total of all reporting groups
11338728|NCT03615924|FG000|Participant Flow|Ticagrelor 15/30/45 mg bd|"Pediatric participants received ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally twice daily (bd) for at least 12 months but no longer than 24 months. The dose of ticagrelor was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of ticagrelor 15 mg (1x15 mg) bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of ticagrelor 15 mg (2x15 mg) bd.~Participants with a body weight >48 kg received 3 tablets of ticagrelor 15 mg (3x15 mg) bd."
11338729|NCT03615924|FG001|Participant Flow|Placebo|"Pediatric participants received placebo matching with ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The number of placebo tablets was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of placebo matching with ticagrelor 15 mg bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of placebo matching with ticagrelor 30 mg bd.~Participants with a body weight >48 kg received 3 tablets of placebo matching with ticagrelor 45 mg bd."
11338730|NCT03615924|OG000|Outcome|Ticagrelor 15/30/45 mg bd|"Pediatric participants received ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The dose of ticagrelor was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of ticagrelor 15 mg (1x15 mg) bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of ticagrelor 15 mg (2x15 mg) bd.~Participants with a body weight >48 kg received 3 tablets of ticagrelor 15 mg (3x15 mg) bd."
11338731|NCT03615924|OG001|Outcome|Placebo|"Pediatric participants received placebo matching with ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The number of placebo tablets was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of placebo matching with ticagrelor 15 mg bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of placebo matching with ticagrelor 30 mg bd.~Participants with a body weight >48 kg received 3 tablets of placebo matching with ticagrelor 45 mg bd."
11338732|NCT03615924|EG000|Reported Event|Ticagrelor 15/30/45 mg bd|"Pediatric participants received ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The dose of ticagrelor was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of ticagrelor 15 mg (1x15 mg) bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of ticagrelor 15 mg (2x15 mg) bd.~Participants with a body weight >48 kg received 3 tablets of ticagrelor 15 mg (3x15 mg) bd."
11338733|NCT03615924|EG001|Reported Event|Placebo|"Pediatric participants received placebo matching with ticagrelor 15 mg, or 30 mg, or 45 mg tablets orally bd for at least 12 months but no longer than 24 months. The number of placebo tablets was determined based on body weight at randomization:~Participants with a body weight ≥12 to ≤24 kg received 1 tablet of placebo matching with ticagrelor 15 mg bd.~Participants with a body weight >24 to ≤48 kg received 2 tablets of placebo matching with ticagrelor 30 mg bd.~Participants with a body weight >48 kg received 3 tablets of placebo matching with ticagrelor 45 mg bd."
11338734|NCT03616106|BG000|Baseline|Providers|This group is comprised of the health care providers who administered the infographic intervention to patient participants.
11338735|NCT03616106|BG001|Baseline|Intervention (Patient Participants)|The intervention group is comprised of the patient participants who received the intervention during clinic visits.
11338736|NCT03616106|BG002|Baseline|Total|Total of all reporting groups
11338737|NCT03616106|FG000|Participant Flow|Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.~Infographic intervention: All study participants will receive health education using infographics during their regularly scheduled clinic appointments."
11338738|NCT03616106|FG001|Participant Flow|Interventionists|Interventionists were the three health care providers who administered the infographic intervention to patient participants.
11338739|NCT03616106|OG000|Outcome|Intervention (Patient Participants)|The intervention group is comprised of the patient participants who received the intervention during clinic visits.
11338740|NCT03616106|EG000|Reported Event|Intervention Group|"Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.~Infographic intervention: All study participants will receive health education using infographics during their regularly scheduled clinic appointments."
11338741|NCT03616106|EG001|Reported Event|Interventionists|Interventionists were the three health care providers who administered the infographic intervention to patient participants.
11338742|NCT03616171|BG000|Baseline|SLEEP-Extend Intervention|Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.
11338743|NCT03616171|BG001|Baseline|Control Group|Participants receiving one educational session consisting of safety practices used for an urban environment.
11338744|NCT03616171|BG002|Baseline|Total|Total of all reporting groups
11338745|NCT03616171|FG000|Participant Flow|SLEEP-Extend Intervention|Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.
11338746|NCT03616171|FG001|Participant Flow|Control Group|Participants receiving one educational session consisting of safety practices used for an urban environment.
11338747|NCT03616171|OG000|Outcome|SLEEP-Extend Intervention|Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.
11338748|NCT03616171|OG001|Outcome|Control Group|Participants receiving one educational session consisting of safety practices used for an urban environment.
11338749|NCT03616171|OG001|Outcome|Control Group|Participants receiving one educational session consisting of safety practices for an urban environment.
11338750|NCT03616171|EG000|Reported Event|SLEEP-Extend Intervention|Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.
11338751|NCT03616171|EG001|Reported Event|Control Group|Participants receiving one educational session consisting of safety practices used for an urban environment.
11338752|NCT03616600|BG000|Baseline|Treatment|"Wearing the orthokeratology lenses for 3 months~Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material"
11338753|NCT03616600|BG001|Baseline|Control|Not wearing any contact lenses
11338754|NCT03616600|BG002|Baseline|Total|Total of all reporting groups
11338755|NCT03616600|FG000|Participant Flow|Treatment|"Wearing the orthokeratology lenses for 3 months~Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material"
11338756|NCT03616600|FG001|Participant Flow|Control|Not wearing any contact lenses
11338757|NCT03616600|OG000|Outcome|Treatment|"Group randomly selected to wear the Breath-O Correct lenses~Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material"
11338758|NCT03616600|OG001|Outcome|Control|Group randomly selected not to wear any contact lenses
11338759|NCT03616600|OG000|Outcome|Treatment|Group randomly selected to wear the Breath-O Correct lenses
11338760|NCT03616600|EG000|Reported Event|Treatment|"Wearing the orthokeratology lenses for 3 months~Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material"
11338761|NCT03616600|EG001|Reported Event|Control|Not wearing any contact lenses
11338762|NCT03616899|BG000|Baseline|KPI-121 0.25% Ophthalmic Suspension|KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
11338763|NCT03616899|BG001|Baseline|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
11338764|NCT03616899|BG002|Baseline|Total|Total of all reporting groups
11338765|NCT03616899|FG000|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
11338766|NCT03616899|FG001|Participant Flow|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
11338767|NCT03616899|OG000|Outcome|KPI-121 0.25% Ophthalmic Suspension|KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
11338768|NCT03616899|OG001|Outcome|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
11338769|NCT03616899|EG000|Reported Event|KPI-121 0.25% Ophthalmic Suspension|KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
11338770|NCT03616899|EG001|Reported Event|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
11338771|NCT03616977|BG000|Baseline|Overall|Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. Single SC dose of LY900014 U-100 in two of four study periods.
11338772|NCT03616977|FG000|Participant Flow|Sequence 1|Single SC dose of LY900014 U-200 in Periods 1 and 3. Single SC dose of LY900014 U-100 in Periods 2 and 4.
11338773|NCT03616977|FG001|Participant Flow|Sequence 2|Single SC dose of LY900014 U-100 in Periods 1 and 3. Single SC dose of LY900014 U-200 in Periods 2 and 4.
11338774|NCT03616977|OG000|Outcome|LY900014 U-100|"Single SC dose of LY900014 U-100 in two of four study periods.~LY900014 U-100: Administered SC"
11338775|NCT03616977|OG001|Outcome|LY900014 U-200|"Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.~LY900014 U-200: Administered SC"
11338776|NCT03616977|OG001|Outcome|LY900014 U-200|"Single SC dose of LY900014 U-200 in two of four study periods.~LY900014 U-200: Administered SC"
11338777|NCT03616977|EG000|Reported Event|LY900014 U-100|Single SC dose of LY900014 U-100.
11338778|NCT03616977|EG001|Reported Event|LY900014 U-200|Single SC dose of LY900014 U-200.
11338779|NCT03617419|BG000|Baseline|VScan Access R2 Ultrasound System|"Pre-market: Vscan Access R2 Ultrasound System~The following post-market products will be used on label:~GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement~GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.~GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.~GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart."
11342428|NCT03707522|FG001|Participant Flow|Control + MRF Information|"Online daily activity scheduling interactive article (control) followed by equal length interactive article describing the relationship between modifiable risk factors and mental health outcomes~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety~Control: 10 minute interactive article describing activity scheduling"
11342429|NCT03707522|FG002|Participant Flow|Control + Growth Mindset|"Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)~Growth mindset: 10 minute interactive article describing neuroplasticity~Control: 10 minute interactive article describing activity scheduling"
11342430|NCT03707522|FG003|Participant Flow|Control + Control|"2 doses online daily activity scheduling interactive article (control)~Control: 10 minute interactive article describing activity scheduling"
11342431|NCT03707522|OG000|Outcome|Growth Mindset + MRF Information|"Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes~Growth mindset: 10 minute interactive article describing neuroplasticity~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety"
11342432|NCT03707522|OG001|Outcome|Control + MRF Information|"Online daily activity scheduling interactive article (control) followed by equal length interactive article describing the relationship between modifiable risk factors and mental health outcomes~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety~Control: 10 minute interactive article describing activity scheduling"
11342433|NCT03707522|OG002|Outcome|Control + Growth Mindset|"Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)~Growth mindset: 10 minute interactive article describing neuroplasticity~Control: 10 minute interactive article describing activity scheduling"
11342434|NCT03707522|OG003|Outcome|Control + Control|"2 doses online daily activity scheduling interactive article (control)~Control: 10 minute interactive article describing activity scheduling"
11342435|NCT03707522|EG000|Reported Event|Growth Mindset + MRF Information|"Online growth mindset interactive article followed by equal length interactive article describing the relationship between modifiable risk factors (MRF) and mental health outcomes~Growth mindset: 10 minute interactive article describing neuroplasticity~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety"
11342436|NCT03707522|EG001|Reported Event|Control + MRF Information|"Online daily activity scheduling interactive article (control) followed by equal length interactive article describing the relationship between modifiable risk factors and mental health outcomes~Modifiable risk factor (MRF) information: 10 minute interactive article describing modifiable risk factors for depression and anxiety~Control: 10 minute interactive article describing activity scheduling"
11342437|NCT03707522|EG002|Reported Event|Control + Growth Mindset|"Online growth mindset interactive article followed by equal length online daily activity scheduling interactive article (control)~Growth mindset: 10 minute interactive article describing neuroplasticity~Control: 10 minute interactive article describing activity scheduling"
11342438|NCT03707522|EG003|Reported Event|Control + Control|"2 doses online daily activity scheduling interactive article (control)~Control: 10 minute interactive article describing activity scheduling"
11342439|NCT03707587|BG000|Baseline|Cohort 1 - Checkpoint Inhibitor Naive Patients|Patients with Recurrent Respiratory Papillomatosis (RRP) who are checkpoint inhibitor naïve will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342440|NCT03707587|BG001|Baseline|Cohort 2 - Patients Refractory to Checkpoint Inhibition|Patients with Recurrent Respiratory Papillomatosis (RRP) who are refractory to checkpoint inhibition will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342441|NCT03707587|BG002|Baseline|Total|Total of all reporting groups
11342442|NCT03707587|FG000|Participant Flow|Cohort 1 - Checkpoint Inhibitor Naive Patients|Patients with Recurrent Respiratory Papillomatosis (RRP) who are checkpoint inhibitor naïve will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342443|NCT03707587|FG001|Participant Flow|Cohort 2 - Patients Refractory to Checkpoint Inhibition|Patients with Recurrent Respiratory Papillomatosis (RRP) who are refractory to checkpoint inhibition will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342444|NCT03707587|OG000|Outcome|Cohort 1 - Checkpoint Inhibitor Naive Patients|Patients with Recurrent Respiratory Papillomatosis (RRP) who are checkpoint inhibitor naïve will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342445|NCT03707587|OG001|Outcome|Cohort 2 - Patients Refractory to Checkpoint Inhibition|Patients with Recurrent Respiratory Papillomatosis (RRP) who are refractory to checkpoint inhibition will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342446|NCT03707587|EG000|Reported Event|Cohort 1 - Checkpoint Inhibitor Naive Patients|Patients with Recurrent Respiratory Papillomatosis (RRP) who are checkpoint inhibitor naïve will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342447|NCT03707587|EG001|Reported Event|Cohort 2 - Patients Refractory to Checkpoint Inhibition|Patients with Recurrent Respiratory Papillomatosis (RRP) who are refractory to checkpoint inhibition will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week.
11342448|NCT03707821|BG000|Baseline|Test|Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
11342449|NCT03707821|BG001|Baseline|Control|All subjects dispensed the Control lens in both eyes throughout the entire duration of the study.
11342450|NCT03707821|BG002|Baseline|Total|Total of all reporting groups
11342451|NCT03707821|FG000|Participant Flow|Test|Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
11342452|NCT03707821|FG001|Participant Flow|Control|Subjects that wore the Control lens in both eyes throughout the entire duration of the study.
11342453|NCT03707821|OG000|Outcome|Test|Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
11342454|NCT03707821|OG001|Outcome|Control|Subjects that wore the Control lens in both eyes during the entire duraiton of the study.
11342455|NCT03707821|EG000|Reported Event|Test|Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
11342456|NCT03707821|EG001|Reported Event|Control|Subjects that wore the Control lens at any point during the study.
11242276|NCT02494336|FG000|Participant Flow|Trans-incisional Rectus Sheath Block|"rectus sheath block under direct visualization through the umbilical incision by the attending surgeon~Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11340803|NCT03665155|EG000|Reported Event|Phase I: Dose Escalation 1-5 mCi in 50mg of Antibody|"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.~Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients)."
11340804|NCT03665155|EG001|Reported Event|Phase I: Dose Escalation 1-5 mCi in 20mg of Antibody|"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.~Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients)."
11340805|NCT03665155|EG002|Reported Event|Phase I: Dose Escalation 1-5 mCi in 3-50mg of Antibody|"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.~Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients)."
11340806|NCT03666026|BG000|Baseline|Standard of Care Control|Participants in this group will not receive any MyChart influenza vaccination reminders
11340807|NCT03666026|BG001|Baseline|1 MyChart R/R|"Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account~1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340808|NCT03666026|BG002|Baseline|2 MyChart R/R|"Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account~2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340809|NCT03666026|BG003|Baseline|3 MyChart R/R|"Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account~3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340810|NCT03666026|BG004|Baseline|Total|Total of all reporting groups
11340811|NCT03666026|FG000|Participant Flow|Standard of Care Control|Participants in this group will not receive any MyChart influenza vaccination reminders
11340812|NCT03666026|FG001|Participant Flow|1 MyChart R/R|"Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account~1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340813|NCT03666026|FG002|Participant Flow|2 MyChart R/R|"Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account~2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340814|NCT03666026|FG003|Participant Flow|3 MyChart R/R|"Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account~3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340815|NCT03666026|OG000|Outcome|Standard of Care Control|Participants in this group will not receive any MyChart influenza vaccination reminders
11340816|NCT03666026|OG001|Outcome|1 MyChart R/R|"Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account~1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340817|NCT03666026|OG002|Outcome|2 MyChart R/R|"Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account~2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340818|NCT03666026|OG003|Outcome|3 MyChart R/R|"Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account~3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340819|NCT03666026|EG000|Reported Event|Standard of Care Control|Participants in this group will not receive any MyChart influenza vaccination reminders
11340820|NCT03666026|EG001|Reported Event|1 MyChart R/R|"Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account~1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340821|NCT03666026|EG002|Reported Event|2 MyChart R/R|"Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account~2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340822|NCT03666026|EG003|Reported Event|3 MyChart R/R|"Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account~3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system."
11340823|NCT03666663|BG000|Baseline|Lidocaine|"Participants will receive SPG blocks with lidocaine.~Lidocaine: Nasal application using the Sphenocath device- cleared by FDA"
11340824|NCT03666663|BG001|Baseline|Bupivacaine|"Participants will receive SPG blocks with bupivacaine~Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340825|NCT03666663|BG002|Baseline|Ropivacaine|"Participants will receive SPG blocks with ropivacaine~Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340826|NCT03666663|BG003|Baseline|Placebo (Saline)|"Participants will receive SPG blocks with placebo (saline)~Placebo: Placebo Saline using the Sphenocath device- cleared by FDA"
11340827|NCT03666663|BG004|Baseline|Total|Total of all reporting groups
11340828|NCT03666663|FG000|Participant Flow|Lidocaine|"Participants will receive SPG blocks with lidocaine.~Lidocaine: Nasal application using the Sphenocath device- cleared by FDA"
11340829|NCT03666663|FG001|Participant Flow|Bupivacaine|"Participants will receive SPG blocks with bupivacaine~Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340830|NCT03666663|FG002|Participant Flow|Ropivacaine|"Participants will receive SPG blocks with ropivacaine~Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340831|NCT03666663|FG003|Participant Flow|Placebo (Saline)|"Participants will receive SPG blocks with placebo (saline)~Placebo: Placebo Saline using the Sphenocath device- cleared by FDA"
11340832|NCT03666663|OG000|Outcome|Lidocaine|"Participants will receive SPG blocks with lidocaine.~Lidocaine: Nasal application using the Sphenocath device- cleared by FDA"
11340833|NCT03666663|OG001|Outcome|Bupivacaine|"Participants will receive SPG blocks with bupivacaine~Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340834|NCT03666663|OG002|Outcome|Ropivacaine|"Participants will receive SPG blocks with ropivacaine~Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340835|NCT03666663|OG003|Outcome|Placebo (Saline)|"Participants will receive SPG blocks with placebo (saline)~Placebo: Placebo Saline using the Sphenocath device- cleared by FDA"
11340836|NCT03666663|EG000|Reported Event|Lidocaine|"Participants will receive SPG blocks with lidocaine.~Lidocaine: Nasal application using the Sphenocath device- cleared by FDA"
11340837|NCT03666663|EG001|Reported Event|Bupivacaine|"Participants will receive SPG blocks with bupivacaine~Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340838|NCT03666663|EG002|Reported Event|Ropivacaine|"Participants will receive SPG blocks with ropivacaine~Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA"
11340839|NCT03666663|EG003|Reported Event|Placebo (Saline)|"Participants will receive SPG blocks with placebo (saline)~Placebo: Placebo Saline using the Sphenocath device- cleared by FDA"
11340840|NCT03666858|BG000|Baseline|Cohort 1 (All Participants): Neosaldina|All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340841|NCT03666858|FG000|Participant Flow|Cohort 1 (All Participants): Neosaldina|All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340842|NCT03666858|FG001|Participant Flow|Cohort 2 (Participants From Cohort 1): Neosaldina|All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340843|NCT03666858|OG000|Outcome|Cohort 2 (Participants From Cohort 1): Neosaldina|All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340844|NCT03666858|OG000|Outcome|Cohort 1 (All Participants): Neosaldina|All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340845|NCT03666858|OG001|Outcome|Cohort 2 (Participants From Cohort 1): Neosaldina|All participants from Cohort 1 who reported pain intensity at 0 and 120 minutes after Neosaldina intake or reported 0 pain before 120 minutes in their first headache report and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340846|NCT03666858|EG000|Reported Event|Cohort 1 (All Participants): Neosaldina|All healthy participants with at least one TTH episode and who were prescribed with 2 tablets of Neosaldina, orally, at maximum of 8 tablets per day for episodic TTH as per regular clinical practice were enrolled in this observational study on Day 1. Participants were instructed to insert the data in an application, downloaded onto mobile phone, whenever they had an episode of TTH and use Neosaldina. Participants were observed from Day 1 until Day 45. Data were also collected from medical charts and during the routine clinical appointment.
11340847|NCT03667053|BG000|Baseline|Dasiglucagon 0.6 mg|"Single fixed dose (subcutaneous injection) of dasiglucagon~dasiglucagon: glucagon analog"
10803949|NCT01049035|EG003|Reported Event|Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months|Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
11340848|NCT03667053|BG001|Baseline|Placebo|"Single fixed dose (subcutaneous injection) of placebo~placebo: placebo for dasiglucagon"
11340849|NCT03667053|BG002|Baseline|GlucaGen® 1.0 mg|"Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)~GlucaGen HypoKit: native glucagon"
11340850|NCT03667053|BG003|Baseline|Total|Total of all reporting groups
11340851|NCT03667053|FG000|Participant Flow|Dasiglucagon 0.6 mg|"Single fixed dose (subcutaneous injection) of dasiglucagon~dasiglucagon: glucagon analog"
11340852|NCT03667053|FG001|Participant Flow|Placebo|"Single fixed dose (subcutaneous injection) of placebo~placebo: placebo for dasiglucagon"
11340853|NCT03667053|FG002|Participant Flow|GlucaGen® 1.0 mg|"Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)~GlucaGen HypoKit: native glucagon"
11340854|NCT03667053|OG000|Outcome|Dasiglucagon 0.6 mg|"Single fixed dose (subcutaneous injection) of dasiglucagon~dasiglucagon: glucagon analog"
11340855|NCT03667053|OG001|Outcome|Placebo|"Single fixed dose (subcutaneous injection) of placebo~placebo: placebo for dasiglucagon"
11340856|NCT03667053|OG002|Outcome|GlucaGen® 1.0 mg|"Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)~GlucaGen HypoKit: native glucagon"
11340857|NCT03667053|OG001|Outcome|GlucaGen® 1.0 mg|"Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)~GlucaGen HypoKit: native glucagon"
11340858|NCT03667053|EG000|Reported Event|Age Group 6-11 Years - Dasiglucagon|Patients in the dasiglucagon group in the age group 6-11 years
11340859|NCT03667053|EG001|Reported Event|Age Group 6-11 Years - Placebo|Patients in the placebo group in the age group 6-11 years
11340860|NCT03667053|EG002|Reported Event|Age Group 6-11 Years - GlucaGen|Patients in the GlucaGen group in the age group 6-11 years
11340861|NCT03667053|EG003|Reported Event|Age Group 12-17 Years - Dasiglucagon|Patients in the dasiglucagon group in the age group 12-17 years
11340862|NCT03667053|EG004|Reported Event|Age Group 12-17 Years - Placebo|Patients in the placebo group in the age group 12-17 years
11340863|NCT03667053|EG005|Reported Event|Age Group 12-17 Years - Glucagen|Patients in the GlucaGen group in the age group 12-17 years
11340864|NCT03667053|EG006|Reported Event|Dasiglucagon 0.6 mg|Full population. Single fixed dose (subcutaneous injection) of dasiglucagon
11340865|NCT03667053|EG007|Reported Event|Placebo|Full population. Single fixed dose (subcutaneous injection) of placebo
11340866|NCT03667053|EG008|Reported Event|GlucaGen® 1.0 mg|Full population. Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)
11340867|NCT03667547|BG000|Baseline|Raltegravir|Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks
11340868|NCT03667547|FG000|Participant Flow|Raltegravir|Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks
11340869|NCT03667547|OG000|Outcome|Raltegravir|Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks
11340870|NCT03667547|EG000|Reported Event|Raltegravir|Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks
11340871|NCT03668600|BG000|Baseline|Rapastinel|Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
11340872|NCT03668600|FG000|Participant Flow|Rapastinel|Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
11340873|NCT03668600|OG000|Outcome|Rapastinel|Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
11340874|NCT03668600|EG000|Reported Event|Rapastinel|Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
11340875|NCT03668613|BG000|Baseline|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing <50 kg) or 150 mg (if weighing >=50 kg) at each dosing
11340876|NCT03668613|BG001|Baseline|AIN457 High Dose|Patients received secukinumab 75 mg (if weighing < 25 kg) or 150 mg (if weighing 25 to < 50 kg ) or 300 mg (if weighing >=50 kg) at each dosing
11340877|NCT03668613|BG002|Baseline|Total|Total of all reporting groups
11340878|NCT03668613|FG000|Participant Flow|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing <50 kg) or 150 mg (if weighing >=50 kg) at each dosing
11340879|NCT03668613|FG001|Participant Flow|AIN457 High Dose|Patients received secukinumab 75 mg (if weighing < 25 kg) or 150 mg (if weighing 25 to < 50 kg ) or 300 mg (if weighing >=50 kg) at each dosing
11340880|NCT03668613|OG000|Outcome|AIN457 Low Dose|Patients received secukinumab 75 mg (if weighing <50 kg) or 150 mg (if weighing >=50 kg) at each dosing
11340881|NCT03668613|OG001|Outcome|AIN457 High Dose|Patients received secukinumab 75 mg (if weighing < 25 kg) or 150 mg (if weighing 25 to < 50 kg ) or 300 mg (if weighing >=50 kg) at each dosing
11340882|NCT03668613|OG000|Outcome|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing <50 kg) or 150 mg (if weighing >=50 kg) at each dosing
11340883|NCT03668613|EG000|Reported Event|AIN457 Low Dose|Patients received secukinumab 75mg (if weighing <50 kg) or 150 mg (if weighing >=50 kg) at each dosing
11340884|NCT03668613|EG001|Reported Event|AIN457 High Dose|Patients received secukinumab 75 mg (if weighing < 25 kg) or 150 mg (if weighing 25 to < 50 kg ) or 300 mg (if weighing >=50 kg) at each dosing
11340885|NCT03669081|BG000|Baseline|Toradol and Lyrica|"Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).~Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.~Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation."
10803950|NCT01049035|EG004|Reported Event|Group 5: MenACYW Conjugate Vaccine: 12 Months|Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
10803951|NCT01049035|EG005|Reported Event|Group 6: Control: 2, 4, 6, and 12 Months|Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
11199273|NCT02185339|FG000|Participant Flow|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
10803952|NCT01049035|EG006|Reported Event|Group 7: Control: 2, 4, 6, 12, and 15 Months|Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
10803953|NCT00728884|BG000|Baseline|Certain Prevail Implants|Osseotite surfaced implants with internal connection
10803954|NCT00728884|FG000|Participant Flow|Certain Prevail Implants|Osseotite surfaced implants with internal connection
10803955|NCT00728884|OG000|Outcome|Certain Prevail Implants|Osseotite surfaced implants with internal connection
10803956|NCT00728884|EG000|Reported Event|Certain Prevail Implants|Osseotite surfaced implants with internal connection
11338780|NCT03617419|FG000|Participant Flow|VScan Access R2 Ultrasound System|"Pre-market: Vscan Access R2 Ultrasound System~The following post-market products will be used on label:~GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement~GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.~GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.~GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart."
11338781|NCT03617419|OG000|Outcome|VScan Access R2 Ultrasound System|"Pre-market: Vscan Access R2 Ultrasound System~The following post-market products will be used on label:~GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement~GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.~GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.~GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart."
11338782|NCT03617419|EG000|Reported Event|VScan Access R2 Ultrasound System|"Pre-market: Vscan Access R2 Ultrasound System~The following post-market products will be used on label:~GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement~GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.~GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.~GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart."
11338783|NCT03617588|BG000|Baseline|Group A|Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.
11338784|NCT03617588|BG001|Baseline|Groups B and C|"Group B: Patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent).~Group C: Patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent)."
11338785|NCT03617588|BG002|Baseline|Total|Total of all reporting groups
11338786|NCT03617588|FG000|Participant Flow|Group A|Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.
11338787|NCT03617588|FG001|Participant Flow|Groups B and C|"Group B: Patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent).~Group C: Patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent)."
11338788|NCT03617588|OG000|Outcome|Group A|Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.
11338789|NCT03617588|OG001|Outcome|Groups B and C|"Group B: Patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent).~Group C: Patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent)."
11338790|NCT03617588|OG002|Outcome|Full Analysis Set|A subset of the safety population who underwent the Visit 2 68Ga-THP-PSMA PET/CT scan, regardless of whether the scan was a technical success or failure.
11338791|NCT03617588|OG003|Outcome|Per Protocol Set|A subset of the Full Analysis Set with at least one technically successful post baseline 68Ga-THP-PSMA PET/CT scan and without any major protocol deviations.
11338792|NCT03617588|OG002|Outcome|Safety Evaluable Population|All patients who received a 68Ga-THP-PSMA PET/CT dose, regardless of whether they received the full intended dose, or proceeded to undergo the intended 68Ga-THP-PSMA PET/CT scan.
11338793|NCT03617588|EG000|Reported Event|Group A|Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.
11338794|NCT03617588|EG001|Reported Event|Groups B and C|"Group B: Patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent).~Group C: Patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent)."
11338795|NCT03617588|EG002|Reported Event|Safety Evaluable Population|All patients who received a 68Ga-THP-PSMA PET/CT dose, regardless of whether they received the full intended dose, or proceeded to undergo the intended 68Ga-THP-PSMA PET/CT scan.
11338796|NCT03617770|BG000|Baseline|Sleep-Opt-In|"Sleep optimization intervention~Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling"
11338797|NCT03617770|BG001|Baseline|Healthy Living|"Health education~Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living."
11338798|NCT03617770|BG002|Baseline|Total|Total of all reporting groups
11338799|NCT03617770|FG000|Participant Flow|Sleep-Opt-In|"Sleep optimization intervention~Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling"
11338800|NCT03617770|FG001|Participant Flow|Healthy Living|"Health education~Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living."
11338801|NCT03617770|OG000|Outcome|Sleep-Opt-In|"Sleep optimization intervention~Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling"
11338802|NCT03617770|OG001|Outcome|Healthy Living|"Health education~Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living."
11338803|NCT03617770|EG000|Reported Event|Sleep-Opt-In|"Sleep optimization intervention~Sleep Opt-In: 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling"
11338804|NCT03617770|EG001|Reported Event|Healthy Living|"Health education~Healthy Living: 8-week intervention that includes weekly telephone counseling on healthy living."
10803957|NCT00727090|BG000|Baseline|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
10800244|NCT02243605|OG000|Outcome|Osteosarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :~a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).~a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising."
11338805|NCT03617861|BG000|Baseline|Healthy Controls|Healthy controls were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.
11338806|NCT03617861|BG001|Baseline|Functional Dyspepsia|Functional Dyspepsia subjects were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.
11338807|NCT03617861|BG002|Baseline|Total|Total of all reporting groups
11338808|NCT03617861|FG000|Participant Flow|Healthy Controls: Secretin Then Placebo|Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
11338809|NCT03617861|FG001|Participant Flow|Healthy Controls: Placebo Then Secretin|Healthy subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
11338810|NCT03617861|FG002|Participant Flow|Functional Dyspepsia: Secretin Then Placebo|Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
11338811|NCT03617861|FG003|Participant Flow|Functional Dyspepsia: Placebo Then Secretin|Functional Dyspepsia subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
11338812|NCT03617861|OG000|Outcome|Healthy Controls: Secretin|Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
11338813|NCT03617861|OG001|Outcome|Healthy Controls: Placebo|Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
11338814|NCT03617861|OG002|Outcome|Functional Dyspepsia: Secretin|Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
11338815|NCT03617861|OG003|Outcome|Functional Dyspepsia: Placebo|Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
11338816|NCT03617861|EG000|Reported Event|Healthy Controls: Secretin|Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min.
11338817|NCT03617861|EG001|Reported Event|Healthy Controls: Placebo|Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
11338818|NCT03617861|EG002|Reported Event|Functional Dyspepsia: Secretin|Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min.
11338819|NCT03617861|EG003|Reported Event|Functional Dyspepsia: Placebo|Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
11338820|NCT03617913|BG000|Baseline|Avelumab and Cisplatin IV|Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
11338821|NCT03617913|FG000|Participant Flow|Avelumab and Cisplatin IV|Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
11338822|NCT03617913|OG000|Outcome|Avelumab and Cisplatin IV|Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
11338823|NCT03617913|EG000|Reported Event|Avelumab and Cisplatin IV|Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
11338824|NCT03618017|BG000|Baseline|Static Care Plan|"The control arm will receive a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care."
11338825|NCT03618017|BG001|Baseline|CCC Website|ConnectedCancerCare (CCC) is a web- based guide to support survivorship care for women who have been treated for early- stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
11338826|NCT03618017|BG002|Baseline|Total|Total of all reporting groups
11338827|NCT03618017|FG000|Participant Flow|Control: Static Care Plan|"The control arm will receive is a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care."
10803958|NCT00727090|BG001|Baseline|Usual Medical Care|Usual care by the attending physician staff
10803959|NCT00727090|BG002|Baseline|Total|Total of all reporting groups
10803960|NCT00727090|FG000|Participant Flow|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
10803961|NCT00727090|FG001|Participant Flow|Usual Medical Care|Usual care by the attending physician staff
10803962|NCT00727090|OG000|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
10803963|NCT00727090|OG001|Outcome|Usual Medical Care|Usual care by the attending physician staff
10803964|NCT00727090|OG000|Outcome|Conivaptan|"Conivaptan in addition to usual care at the discretion of the attending medical staff~Conivaptan: Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours"
10803965|NCT00727090|OG001|Outcome|Usual Care|Usual care by the attending physician staff
10803966|NCT00727090|EG000|Reported Event|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
10803967|NCT00727090|EG001|Reported Event|Usual Medical Care|Usual care by the attending physician staff
10803968|NCT00726063|BG000|Baseline|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
10803969|NCT00726063|BG001|Baseline|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
10800245|NCT02243605|OG000|Outcome|Ewing Sarcoma|"Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).~Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.~Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising."
10800246|NCT02243605|EG000|Reported Event|Osteosarcoma|Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11338828|NCT03618017|FG001|Participant Flow|Intervention: CCC Website|ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
10800247|NCT02243605|EG001|Reported Event|Ewing Sarcoma|Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10803970|NCT00726063|BG002|Baseline|Total|Total of all reporting groups
10803971|NCT00726063|FG000|Participant Flow|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
11338829|NCT03618017|OG000|Outcome|Recruitment Population|Pre-randomization recruitment and enrollment
11338830|NCT03618017|OG000|Outcome|Intervention: CCC Website|ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
11338831|NCT03618017|OG000|Outcome|Control: Static Care Plan|"The control arm will receive a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care."
11338832|NCT03618017|OG001|Outcome|Intervention: CCC Website|ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
11338833|NCT03618017|EG000|Reported Event|Control: Static Care Plan|"The control arm will receive a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care."
11338834|NCT03618017|EG001|Reported Event|Intervention: CCC Website|ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
11338835|NCT03618030|BG000|Baseline|Active Treatment|"PRC-063 (all doses combined)~PRC-063 oral capsules: Daily dose"
11338836|NCT03618030|BG001|Baseline|Placebo Treatment|"Matched placebo~Placebo oral capsules: Daily dose"
11338837|NCT03618030|BG002|Baseline|Total|Total of all reporting groups
11338838|NCT03618030|FG000|Participant Flow|PRC-063 25 mg|PRC-063 oral capsules: Daily dose
11338839|NCT03618030|FG001|Participant Flow|PRC-063 35 mg|PRC-063 oral capsules: Daily dose
11338840|NCT03618030|FG002|Participant Flow|PRC-063 45 mg|PRC-063 oral capsules: Daily dose
11338841|NCT03618030|FG003|Participant Flow|PRC-063 55 mg|PRC-063 oral capsules: Daily dose
11338842|NCT03618030|FG004|Participant Flow|PRC-063 70 mg|PRC-063 oral capsules: Daily dose
11338843|NCT03618030|FG005|Participant Flow|PRC-063 85 mg|PRC-063 oral capsules: Daily dose
11338844|NCT03618030|FG006|Participant Flow|PRC-063 100 mg|PRC-063 oral capsules: Daily dose
11338845|NCT03618030|FG007|Participant Flow|Placebo Treatment|"Matched placebo~Placebo oral capsules: Daily dose"
11338846|NCT03618030|OG000|Outcome|Double-Blind Active Treatment|"PRC-063 (all doses combined)~PRC-063 oral capsules: Daily dose"
11338847|NCT03618030|OG001|Outcome|Double-Blind Placebo Treatment|"Matched placebo~Placebo oral capsules: Daily dose"
11338848|NCT03618030|EG000|Reported Event|Dose-Optimization|PRC-063 25, 35, 45, 55, 70, 85, or 100 mg oral capsules: Daily dose
11338849|NCT03618030|EG001|Reported Event|Double-Blind PRC-063 25 mg|PRC-063 oral capsules: Daily dose
11338850|NCT03618030|EG002|Reported Event|Double-Blind PRC-063 35 mg|PRC-063 oral capsules: Daily dose
11338851|NCT03618030|EG003|Reported Event|Double-Blind PRC-063 45 mg|PRC-063 oral capsules: Daily dose
11338852|NCT03618030|EG004|Reported Event|Double-Blind PRC-063 55 mg|PRC-063 oral capsules: Daily dose
11338853|NCT03618030|EG005|Reported Event|Double-Blind PRC-063 70 mg|PRC-063 oral capsules: Daily dose
11338854|NCT03618030|EG006|Reported Event|Double-Blind PRC-063 85 mg|PRC-063 oral capsules: Daily dose
11338855|NCT03618030|EG007|Reported Event|Double-Blind PRC-063 100 mg|PRC-063 oral capsules: Daily dose
11338856|NCT03618030|EG008|Reported Event|Double-Blind Placebo Treatment|Matched placebo Placebo oral capsules: Daily dose
11338857|NCT03618147|BG000|Baseline|PID Arab Patients|All patients diagnosed with PID
11338858|NCT03618147|FG000|Participant Flow|PID Patients|All patients who were diagnosed with primary immunodeficiency
11338859|NCT03618147|OG000|Outcome|PID Patients|All patients who were diagnosed with primary immunodeficiency
11338860|NCT03618147|OG000|Outcome|PID Patients|PID Arab patients
11338861|NCT03618147|EG000|Reported Event|PID Patients|All patients who were diagnosed with primary immunodeficiency
11338862|NCT03618628|BG000|Baseline|People Using a CFO|"People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.~Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO."
11340886|NCT03669081|BG001|Baseline|Placebo and Standard of Care|"Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.~Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation.~Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively."
11340887|NCT03669081|BG002|Baseline|Total|Total of all reporting groups
11199274|NCT02185339|FG001|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199275|NCT02185339|OG000|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199276|NCT02185339|OG001|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199277|NCT02185339|EG000|Reported Event|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199278|NCT02185339|EG001|Reported Event|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
11199279|NCT02185404|BG000|Baseline|Wearing the iStride Device|The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
11199280|NCT02185404|FG000|Participant Flow|Wearing the iStride Device|The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
11199281|NCT02185404|OG000|Outcome|Wearing the iStride Device|The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
11199282|NCT02185404|EG000|Reported Event|Wearing the iStride Device|The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
11199283|NCT02185521|BG000|Baseline|Visible HII - Patient Assessment|"Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system.~If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.~Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII."
10803972|NCT00726063|FG001|Participant Flow|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
10803973|NCT00726063|OG000|Outcome|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
11242277|NCT02494336|FG001|Participant Flow|Laparoscopic Guided Rectus Sheath Block|"rectus sheath block under direct laparoscopic visualization by the attending surgeon~Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
10803974|NCT00726063|OG001|Outcome|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
10803975|NCT00726063|EG000|Reported Event|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
10803976|NCT00726063|EG001|Reported Event|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
11242278|NCT02494336|OG000|Outcome|Trans-incisional Rectus Sheath Block|"rectus sheath block under direct visualization through the umbilical incision by the attending surgeon~Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
10803977|NCT00725049|BG000|Baseline|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
10803978|NCT00725049|BG001|Baseline|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
10803979|NCT00725049|BG002|Baseline|Total|Total of all reporting groups
10803980|NCT00725049|FG000|Participant Flow|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
10803981|NCT00725049|FG001|Participant Flow|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
10803982|NCT00725049|OG000|Outcome|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
10803983|NCT00725049|OG001|Outcome|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
10966091|NCT00885534|OG000|Outcome|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
10966092|NCT00885534|EG000|Reported Event|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
10966093|NCT00885638|BG000|Baseline|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
11199284|NCT02185521|FG000|Participant Flow|Visible HII - Patient Assessment|"Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system.~If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.~Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII."
11199285|NCT02185521|OG000|Outcome|Visible HII - Patient Assessment|"Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system for individual subjects randomized into HII group arm.~If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.~patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII."
11199286|NCT02185521|OG000|Outcome|Visible HII - Patient Assessment|"Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system.~If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.~Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII."
11199287|NCT02185521|EG000|Reported Event|Visible HII - Patient Assessment|"Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system.~If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.~Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII."
11199288|NCT02185534|BG000|Baseline|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
11199289|NCT02185534|BG001|Baseline|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
11199290|NCT02185534|BG002|Baseline|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
11199291|NCT02185534|BG003|Baseline|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
11199292|NCT02185534|BG004|Baseline|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
11199293|NCT02185534|BG005|Baseline|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
11199294|NCT02185534|BG006|Baseline|Total|Total of all reporting groups
11199295|NCT02185534|FG000|Participant Flow|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
11199296|NCT02185534|FG001|Participant Flow|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
11199297|NCT02185534|FG002|Participant Flow|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
11199298|NCT02185534|FG003|Participant Flow|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
11199299|NCT02185534|FG004|Participant Flow|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
11199300|NCT02185534|FG005|Participant Flow|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
11199301|NCT02185534|OG000|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
11199302|NCT02185534|OG001|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
11199303|NCT02185534|OG002|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
10803984|NCT00725049|EG000|Reported Event|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
10803985|NCT00725049|EG001|Reported Event|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
10803986|NCT00713206|BG000|Baseline|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
11199304|NCT02185534|EG000|Reported Event|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
11199305|NCT02185534|EG001|Reported Event|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
11199306|NCT02185534|EG002|Reported Event|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
11199307|NCT02185534|EG003|Reported Event|Total Number of Participants|total number of subjects exposed to any treatment
11199308|NCT02185729|BG000|Baseline|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
11199309|NCT02185729|FG000|Participant Flow|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
11199310|NCT02185729|OG000|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
11199311|NCT02185729|OG001|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
11199312|NCT02185729|OG002|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
11199313|NCT02185729|OG003|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
11199314|NCT02185729|EG000|Reported Event|Healthy Volunteer|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
11199315|NCT02185794|BG000|Baseline|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.
11199316|NCT02185794|BG001|Baseline|Voxilaprevir 50 mg|Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199317|NCT02185794|BG002|Baseline|Voxilaprevir 100 mg|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199318|NCT02185794|BG003|Baseline|Voxilaprevir 300 mg|Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199319|NCT02185794|BG004|Baseline|Voxilaprevir 100 mg Fed|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199320|NCT02185794|BG005|Baseline|Voxilaprevir 100 mg + SOF/VEL 400/100 mg|Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.
11199321|NCT02185794|BG006|Baseline|Total|Total of all reporting groups
11199322|NCT02185794|FG000|Participant Flow|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.
11199323|NCT02185794|FG001|Participant Flow|Voxilaprevir 50 mg|Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199324|NCT02185794|FG002|Participant Flow|Voxilaprevir 100 mg|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199325|NCT02185794|FG003|Participant Flow|Voxilaprevir 300 mg|Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199326|NCT02185794|FG004|Participant Flow|Voxilaprevir 100 mg Fed|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199327|NCT02185794|FG005|Participant Flow|Voxilaprevir 100 mg + SOF/VEL 400/100 mg|Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10.
11199328|NCT02185794|OG000|Outcome|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
11199329|NCT02185794|OG001|Outcome|Voxilaprevir 50 mg|Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199330|NCT02185794|OG002|Outcome|Voxilaprevir 100 mg|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199331|NCT02185794|OG003|Outcome|Voxilaprevir 300 mg|Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199332|NCT02185794|OG004|Outcome|Voxilaprevir 100 mg Fed|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199333|NCT02185794|OG005|Outcome|Voxilaprevir 100 mg + SOF/VEL 400/100 mg|Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.
11199334|NCT02185794|OG000|Outcome|Placebo (GT 1a, Cohort 1)|Participants with genotype (GT) 1a HCV infection received placebo once daily for 3 days under fasted conditions.
10803987|NCT00713206|BG001|Baseline|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
10803988|NCT00713206|BG002|Baseline|Total|Total of all reporting groups
11199335|NCT02185794|OG001|Outcome|Voxilaprevir 50 mg (GT 1a, Cohort 1)|Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.
11199336|NCT02185794|OG002|Outcome|Voxilaprevir 100 mg (GT 1a, Cohort 1)|Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
11199337|NCT02185794|OG003|Outcome|Voxilaprevir 300 mg (GT 1a, Cohort 1)|Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
11199338|NCT02185794|OG004|Outcome|Placebo (GT 3, Cohort 2)|Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.
11199339|NCT02185794|OG005|Outcome|Voxilaprevir 50 mg (GT 3, Cohort 2)|Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.
11199340|NCT02185794|OG006|Outcome|Voxilaprevir 100 mg (GT 3, Cohort 2)|Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
11199341|NCT02185794|OG007|Outcome|Voxilaprevir 300 mg (GT 3, Cohort 2)|Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
11199342|NCT02185794|OG008|Outcome|Placebo (GT 2, Cohort 3)|Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
11199343|NCT02185794|OG009|Outcome|Voxilaprevir 100 mg (GT 2, Cohort 3)|Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
11199344|NCT02185794|OG010|Outcome|Voxilaprevir 100 mg (GT 4, Cohort 4)|Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
11199345|NCT02185794|OG011|Outcome|Voxilaprevir 100 mg (GT 1b, Cohort 5)|Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
11199346|NCT02185794|OG012|Outcome|Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)|Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
11199347|NCT02185794|OG000|Outcome|Placebo (GT 1a, Cohort 1)|Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.
11199348|NCT02185794|EG000|Reported Event|Placebo|Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
11199349|NCT02185794|EG001|Reported Event|Voxilaprevir 50 mg|Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199350|NCT02185794|EG002|Reported Event|Voxilaprevir 100 mg|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199351|NCT02185794|EG003|Reported Event|Voxilaprevir 300 mg|Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
11199352|NCT02185794|EG004|Reported Event|Voxilaprevir 100 mg Fed|Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
11199353|NCT02185794|EG005|Reported Event|Voxilaprevir 100 mg + SOF/VEL 400/100 mg|Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.
11199354|NCT02186015|BG000|Baseline|Cholecalciferol|Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks
11199355|NCT02186015|BG001|Baseline|No Cholecalciferol|Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
11199356|NCT02186015|BG002|Baseline|Total|Total of all reporting groups
11199357|NCT02186015|FG000|Participant Flow|Cholecalciferol|"All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.~Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks."
11199358|NCT02186015|FG001|Participant Flow|No Cholecalciferol|Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
11199359|NCT02186015|OG000|Outcome|Cholecalciferol|Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.
11199360|NCT02186015|OG001|Outcome|No Cholecalciferol|Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
11199361|NCT02186015|OG000|Outcome|Cholecalciferol|"All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.~Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks."
11199362|NCT02186015|EG000|Reported Event|Intervention|Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks
11199363|NCT02186015|EG001|Reported Event|No Intervention|Enrolled women without serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
11199364|NCT02186171|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections once a month (QM) for 12 months.
11199365|NCT02186171|BG001|Baseline|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11199366|NCT02186171|BG002|Baseline|Total|Total of all reporting groups
11199367|NCT02186171|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a month (QM) for 12 months.
11199368|NCT02186171|FG001|Participant Flow|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11199369|NCT02186171|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections once a month (QM) for 12 months.
11199370|NCT02186171|OG001|Outcome|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11199371|NCT02186171|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections once a month (QM) for 12 months.
11199372|NCT02186171|EG001|Reported Event|Romosozumab 210 mg|Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
11199373|NCT02186210|BG000|Baseline|Prewarming|"prewarming during induction of anesthesia~prewarming: recovery slope StO2"
11199374|NCT02186210|BG001|Baseline|Control|no prewarming during induction of anesthesia
11199375|NCT02186210|BG002|Baseline|Total|Total of all reporting groups
11199376|NCT02186210|FG000|Participant Flow|Prewarming|"prewarming during induction of anesthesia~prewarming: recovery slope StO2"
11199377|NCT02186210|FG001|Participant Flow|Control|no prewarming during induction of anesthesia
11199378|NCT02186210|OG000|Outcome|Prewarming|"prewarming during induction of anesthesia~prewarming: recovery slope StO2"
11199379|NCT02186210|OG001|Outcome|Control|no prewarming during induction of anesthesia
11199380|NCT02186210|OG000|Outcome|Prewarming|prewarming during induction of anesthesia at 3 hr after induction
11199381|NCT02186210|OG001|Outcome|Control|no prewarming during induction of anesthesia at 3 hr after induction
11199382|NCT02186210|EG000|Reported Event|Prewarming|"prewarming during induction of anesthesia~prewarming: recovery slope StO2"
11199383|NCT02186210|EG001|Reported Event|Control|no prewarming during induction of anesthesia
11199384|NCT02186223|BG000|Baseline|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
10966094|NCT00885638|FG000|Participant Flow|Placebo First, Then Sitagliptin|First intervention 1 day, washout 14 days, second intervention 1 day
10966095|NCT00885638|FG001|Participant Flow|Sitagliptin First, Then Placebo|First intervention 1 day, washout 14 days, second intervention 1 day
10803989|NCT00713206|FG000|Participant Flow|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
10966096|NCT00885638|OG000|Outcome|Placebo|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo
10966097|NCT00885638|OG001|Outcome|Sitagliptin|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
10966098|NCT00885638|OG000|Outcome|Placebo|A placebo tablet is given before ingestion of meal
10966099|NCT00885638|OG001|Outcome|Sitagliptin|Sitagliptin is given before ingestion of meal
10803990|NCT00713206|FG001|Participant Flow|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
10803991|NCT00713206|OG000|Outcome|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
11199385|NCT02186223|FG000|Participant Flow|The Angel® Catheter|"All eligible subjects will receive an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
11199386|NCT02186223|OG000|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
11199387|NCT02186223|OG000|Outcome|Angel® Catheter Pre-Removal Cavogram|Number analyzed includes all subjects that had an Angel® Catheter placed, and a cavogram was performed prior to removal.
11199388|NCT02186223|EG000|Reported Event|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
11199389|NCT02186301|BG000|Baseline|Rociletinib 500mg Tablets|Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199390|NCT02186301|BG001|Baseline|Rociletinib 625mg Tablets|Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199391|NCT02186301|BG002|Baseline|Erlotinib 150mg Tablets|Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199392|NCT02186301|BG003|Baseline|Total|Total of all reporting groups
11199393|NCT02186301|FG000|Participant Flow|Rociletinib 500mg Tablets|Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199394|NCT02186301|FG001|Participant Flow|Rociletinib 625mg Tablets|Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199395|NCT02186301|FG002|Participant Flow|Erlotinib 150mg Tablets|Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199396|NCT02186301|OG000|Outcome|Rociletinib 500mg Tablets|Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199397|NCT02186301|OG001|Outcome|Rociletinib 625mg Tablets|Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199398|NCT02186301|OG002|Outcome|Erlotinib 150mg Tablets|Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199399|NCT02186301|EG000|Reported Event|Rociletinib 500mg Tablets|Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199400|NCT02186301|EG001|Reported Event|Rociletinib 625mg Tablets|Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199401|NCT02186301|EG002|Reported Event|Erlotinib 150mg Tablets|Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11199402|NCT02186301|EG003|Reported Event|Crossover From Erlotinib 150mg to Rociletinib 500mg|"Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686.~Starting dose of 500mg CO-1686. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression."
11199403|NCT02186301|EG004|Reported Event|Crossover From Erlotinib 150mg to Rociletinib 625mg|"Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686.~Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression."
11340888|NCT03669081|FG000|Participant Flow|Toradol and Lyrica|"Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).~Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.~Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation."
11340889|NCT03669081|FG001|Participant Flow|Placebo and Standard of Care|"Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.~Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation.~Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively."
11340890|NCT03669081|OG000|Outcome|Toradol and Lyrica|"Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).~Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.~Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation."
10803992|NCT00713206|OG001|Outcome|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
11199404|NCT02186509|BG000|Baseline|Alisertib, Fractionated Stereotactic Radiosurgery|"CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days.~MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy~Stereotactic radiosurgery: Undergo stereotactic radiosurgery~Alisertib: Given PO~Quality-of-life assessment: Ancillary studies"
11199405|NCT02186509|FG000|Participant Flow|Alisertib, Fractionated Stereotactic Radiosurgery|"CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days.~MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy~Stereotactic radiosurgery: Undergo stereotactic radiosurgery~Alisertib: Given PO~Quality-of-life assessment: Ancillary studies"
11199406|NCT02186509|OG000|Outcome|Alisertib, Fractionated Stereotactic Radiosurgery|"CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days.~MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy~Stereotactic radiosurgery: Undergo stereotactic radiosurgery~Alisertib: Given PO~Quality-of-life assessment: Ancillary studies"
11199407|NCT02186509|EG000|Reported Event|Alisertib, Fractionated Stereotactic Radiosurgery|"CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days.~MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy~Stereotactic radiosurgery: Undergo stereotactic radiosurgery~Alisertib: Given PO~Quality-of-life assessment: Ancillary studies"
11199408|NCT02186561|BG000|Baseline|PREMIER|The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
11199409|NCT02186561|FG000|Participant Flow|PREMIER|The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
11199410|NCT02186561|OG000|Outcome|PREMIER|The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
11199411|NCT02186561|EG000|Reported Event|CEC Adjudicated Adverse Events Through 1-Year|Participants who received the Investigational Device followed through 1 Year
11199412|NCT02186561|EG001|Reported Event|CEC Adjudicated Adverse Events Through 2-Year|Participants who received the Investigational Device followed through 2 Year
11199413|NCT02186561|EG002|Reported Event|CEC Adjudicated Adverse Events Through 3-Year|Participants who received the Investigational Device followed through 3 Year
11199414|NCT02186587|BG000|Baseline|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
11199415|NCT02186587|BG001|Baseline|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.~Off-the-shelf total knee implant"
11199416|NCT02186587|BG002|Baseline|Total|Total of all reporting groups
11199417|NCT02186587|FG000|Participant Flow|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
11199418|NCT02186587|FG001|Participant Flow|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
11199419|NCT02186587|OG000|Outcome|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
10803993|NCT00713206|EG000|Reported Event|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
11199420|NCT02186587|EG000|Reported Event|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
11199421|NCT02186587|EG001|Reported Event|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
11199422|NCT02186652|BG000|Baseline|Pantoprazole 6-11 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11342457|NCT03707912|BG000|Baseline|Anaferon|"1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.~Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.~Anaferon: Oral administration."
11342458|NCT03707912|BG001|Baseline|Placebo|"Placebo using Anaferon regimen until the end of the study.~Placebo: Oral administration."
11342459|NCT03707912|BG002|Baseline|Total|Total of all reporting groups
10803994|NCT00713206|EG001|Reported Event|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
10800252|NCT02213380|BG000|Baseline|Group GA|General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
10966100|NCT00885638|EG000|Reported Event|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
11199423|NCT02186652|BG001|Baseline|Pantoprazole 12-17 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11199424|NCT02186652|BG002|Baseline|Total|Total of all reporting groups
10800253|NCT02213380|BG001|Baseline|Group RA|Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
10800254|NCT02213380|BG002|Baseline|Total|Total of all reporting groups
10800255|NCT02213380|FG000|Participant Flow|Group RA|Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
10966101|NCT00885677|BG000|Baseline|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
11199425|NCT02186652|FG000|Participant Flow|Pantoprazole 6-11 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11199426|NCT02186652|FG001|Participant Flow|Pantoprazole 12-17 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11199427|NCT02186652|OG000|Outcome|Pantoprazole 6-11 Year Old|same as the participant flow wording.
11199428|NCT02186652|OG001|Outcome|Pantoprazole 12-17 Year Old|same as participant flow wording.
11199429|NCT02186652|OG000|Outcome|Pantoprazole 6-11 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11199430|NCT02186652|OG001|Outcome|Pantoprazole 12-17 Year Old|"The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.~During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information."
11199431|NCT02186652|OG000|Outcome|Pantoprazole 6-11 Year Old|Edit to include: dosing and any info about the participants experience and how they were treated.
11199432|NCT02186652|OG001|Outcome|Pantoprazole 12-17 Year Old|same as other arm description
11199433|NCT02186652|OG000|Outcome|*2*2 Allele|Poor metabolizer
11199434|NCT02186652|OG001|Outcome|*1/*2 Allele|Intermediate Metabolizer
11199435|NCT02186652|OG002|Outcome|*1/*1 Allele or *1/*17 Allele|Extensive Metabolizer
11199436|NCT02186652|EG000|Reported Event|6-11 Year Old Adverse Events|Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.
11199437|NCT02186652|EG001|Reported Event|12-17 Year Old Adverse Events|Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.
10966102|NCT00885677|BG001|Baseline|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
10966103|NCT00885677|BG002|Baseline|Total|Total of all reporting groups
11199438|NCT02186665|BG000|Baseline|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
11199439|NCT02186665|BG001|Baseline|Placebo|Placebo comparator
11199440|NCT02186665|BG002|Baseline|Total|Total of all reporting groups
11199441|NCT02186665|FG000|Participant Flow|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
11199442|NCT02186665|FG001|Participant Flow|Placebo|Placebo comparator
11199443|NCT02186665|OG000|Outcome|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
11199444|NCT02186665|OG001|Outcome|Placebo|Placebo Comparator
11199445|NCT02186665|EG000|Reported Event|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
11199446|NCT02186665|EG001|Reported Event|Placebo|Placebo Comparator
11199447|NCT02186795|BG000|Baseline|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
11199448|NCT02186795|BG001|Baseline|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11199449|NCT02186795|BG002|Baseline|Total|Total of all reporting groups
11199450|NCT02186795|FG000|Participant Flow|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
11199451|NCT02186795|FG001|Participant Flow|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
10800256|NCT02213380|FG001|Participant Flow|Group GA|General anesthesia (general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
11199452|NCT02186795|OG000|Outcome|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
11199453|NCT02186795|OG001|Outcome|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11199454|NCT02186795|EG000|Reported Event|Lumbar Plexus|Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
11199455|NCT02186795|EG001|Reported Event|Lumbar Epidural|Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
11199456|NCT02186808|BG000|Baseline|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
11199457|NCT02186808|FG000|Participant Flow|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
11199458|NCT02186808|OG000|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
11199459|NCT02186808|EG000|Reported Event|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
11199460|NCT02186821|BG000|Baseline|Ceritinib 750 mg|Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
11199461|NCT02186821|FG000|Participant Flow|Ceritinib 750 mg|Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
11199462|NCT02186821|OG000|Outcome|Ceritinib 750 mg|Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
11199463|NCT02186821|EG000|Reported Event|Ceritinib 750 mg|Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
11199464|NCT02186873|BG000|Baseline|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
10966104|NCT00885677|FG000|Participant Flow|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
11199465|NCT02186873|BG001|Baseline|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
11199466|NCT02186873|BG002|Baseline|Total|Total of all reporting groups
11199467|NCT02186873|FG000|Participant Flow|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
11199468|NCT02186873|FG001|Participant Flow|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
11199469|NCT02186873|OG000|Outcome|Group 1: Placebo Then Golimumab|Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
11199470|NCT02186873|OG001|Outcome|Group 2: Golimumab|Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
11199471|NCT02186873|EG000|Reported Event|Placebo|Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.
11199472|NCT02186873|EG001|Reported Event|Placebo Then Golimumab 2 mg/kg|Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.
11199473|NCT02186873|EG002|Reported Event|Golimumab 2 mg/kg|Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.
11199474|NCT02186938|BG000|Baseline|Treatment Group|FloTrac device was used to manage blood pressure during surgery.
11199475|NCT02186938|BG001|Baseline|Control Group|FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
11199476|NCT02186938|BG002|Baseline|Total|Total of all reporting groups
11199477|NCT02186938|FG000|Participant Flow|Treatment Group|FloTrac device was used to manage blood pressure during surgery.
11199478|NCT02186938|FG001|Participant Flow|Control Group|FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
11199479|NCT02186938|OG000|Outcome|Treatment Group|FloTrac device was used to manage blood pressure during surgery.
11199480|NCT02186938|OG001|Outcome|Control Group|FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
11199481|NCT02186938|EG000|Reported Event|Treatment Group|FloTrac device was used to manage blood pressure during surgery.
11199482|NCT02186938|EG001|Reported Event|Control Group|FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
11199483|NCT02187016|BG000|Baseline|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199484|NCT02187016|BG001|Baseline|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199485|NCT02187016|BG002|Baseline|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
11199486|NCT02187016|BG003|Baseline|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
11199487|NCT02187016|BG004|Baseline|Total|Total of all reporting groups
11199488|NCT02187016|FG000|Participant Flow|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199489|NCT02187016|FG001|Participant Flow|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199490|NCT02187016|FG002|Participant Flow|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
11199491|NCT02187016|FG003|Participant Flow|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
11199492|NCT02187016|OG000|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199493|NCT02187016|OG001|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199494|NCT02187016|OG002|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
11199495|NCT02187016|OG003|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
11199496|NCT02187016|EG000|Reported Event|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199497|NCT02187016|EG001|Reported Event|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
11199498|NCT02187016|EG002|Reported Event|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
11199499|NCT02187016|EG003|Reported Event|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
11199500|NCT02187029|BG000|Baseline|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
11199501|NCT02187029|BG001|Baseline|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
11199502|NCT02187029|BG002|Baseline|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
11199503|NCT02187029|BG003|Baseline|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
11199504|NCT02187029|BG004|Baseline|Total|Total of all reporting groups
11199505|NCT02187029|FG000|Participant Flow|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
11199506|NCT02187029|FG001|Participant Flow|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
11199507|NCT02187029|FG002|Participant Flow|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
11199508|NCT02187029|FG003|Participant Flow|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
11199509|NCT02187029|OG000|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
11199510|NCT02187029|OG001|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
11199511|NCT02187029|OG002|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
11199512|NCT02187029|OG003|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
11199513|NCT02187029|EG000|Reported Event|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
11199514|NCT02187029|EG001|Reported Event|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
11199515|NCT02187029|EG002|Reported Event|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
11199516|NCT02187029|EG003|Reported Event|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
11199517|NCT02187042|BG000|Baseline|Call Center|Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.
11199518|NCT02187042|BG001|Baseline|Standard of Care|Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
11199519|NCT02187042|BG002|Baseline|Total|Total of all reporting groups
11199520|NCT02187042|FG000|Participant Flow|Call Center|Participants with advanced/metastatic renal cell carcinoma (a/mRCC) being treated first line with sunitinib (dose as per the recommendations in the summary or product characteristics [SmPC]) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.
11199521|NCT02187042|FG001|Participant Flow|Standard of Care|Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
11199522|NCT02187042|OG000|Outcome|Call Center|Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.
11199523|NCT02187042|OG001|Outcome|Standard of Care|Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
11199524|NCT02187042|OG000|Outcome|Physicians|Physicians who were investigating the participants being followed up by call center along with conventional method in the study.
11199525|NCT02187042|EG000|Reported Event|Call Center|Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.
11199526|NCT02187042|EG001|Reported Event|Standard of Care|Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
11199527|NCT02187055|BG000|Baseline|Tofacitinib 5 mg BID|One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
11199528|NCT02187055|BG001|Baseline|Tofacitinib 5 mg BID + MTX|One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
11199529|NCT02187055|BG002|Baseline|Adalimumab 40 mg + MTX|One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
11199530|NCT02187055|BG003|Baseline|Total|Total of all reporting groups
11199531|NCT02187055|FG000|Participant Flow|Tofacitinib 5 mg BID|One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
11199532|NCT02187055|FG001|Participant Flow|Tofacitinib 5 mg BID + MTX|One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
11199533|NCT02187055|FG002|Participant Flow|Adalimumab 40 mg + MTX|One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
11199534|NCT02187055|OG000|Outcome|Tofacitinib 5 mg BID|One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
11199535|NCT02187055|OG001|Outcome|Tofacitinib 5 mg BID + MTX|One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
11199536|NCT02187055|OG002|Outcome|Adalimumab 40 mg + MTX|One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
11199537|NCT02187055|EG000|Reported Event|Tofacitinib 5 mg BID|One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.
11199538|NCT02187055|EG001|Reported Event|Tofacitinib 5 mg BID + MTX|One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.
11199539|NCT02187055|EG002|Reported Event|Adalimumab 40 mg + MTX|One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.
11199540|NCT02187159|BG000|Baseline|Placebo|Participants take one each of placebo tablet and capsule BID)
11199541|NCT02187159|BG001|Baseline|Pregabalin|Participants take one pregabalin capsule and one placebo tablet BID
11199542|NCT02187159|BG002|Baseline|DS-5565 QD|Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
11199543|NCT02187159|BG003|Baseline|DS-5565 BID|Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)
11199544|NCT02187159|BG004|Baseline|Total|Total of all reporting groups
11199545|NCT02187159|FG000|Participant Flow|Placebo|Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).
11199546|NCT02187159|FG001|Participant Flow|Pregabalin 150 mg BID|Participants who received oral pregabalin 150 mg twice daily (BID).
11199547|NCT02187159|FG002|Participant Flow|DS-5565 15 mg QD|Participants who received oral DS5565 15 mg once daily (QD).
11199548|NCT02187159|FG003|Participant Flow|DS-5565 15 mg BID|Participants who received DS-5565 15 mg twice daily (BID).
11199549|NCT02187159|OG000|Outcome|Placebo|Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).
11199550|NCT02187159|OG001|Outcome|Pregabalin 150 mg BID|Participants who received oral pregabalin 150 mg twice daily (BID).
11199551|NCT02187159|OG002|Outcome|DS-5565 15 mg QD|Participants who received oral DS5565 15 mg once daily (QD).
11199552|NCT02187159|OG003|Outcome|DS-5565 15 mg BID|Participants who received DS-5565 15 mg twice daily (BID).
11242279|NCT02494336|OG001|Outcome|Laparoscopic Guided Rectus Sheath Block|"rectus sheath block under direct laparoscopic visualization by the attending surgeon~Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11242280|NCT02494336|EG000|Reported Event|Trans-incisional Rectus Sheath Block|"rectus sheath block under direct visualization through the umbilical incision by the attending surgeon~Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11242281|NCT02494336|EG001|Reported Event|Laparoscopic Guided Rectus Sheath Block|"rectus sheath block under direct laparoscopic visualization by the attending surgeon~Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms."
11242282|NCT02494401|BG000|Baseline|Internet-based Self-management Program|"Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.~Internet-based self-management program"
11242283|NCT02494401|BG001|Baseline|Education Book Group|"Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.~Scleroderma book"
11242284|NCT02494401|BG002|Baseline|Total|Total of all reporting groups
11242285|NCT02494401|FG000|Participant Flow|Internet-based Self-management Program|"Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.~Internet-based self-management program"
11242286|NCT02494401|FG001|Participant Flow|Education Book Group|"Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.~Scleroderma book"
11242287|NCT02494401|OG000|Outcome|Internet-based Self-management Program|"Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.~Internet-based self-management program"
11242288|NCT02494401|OG001|Outcome|Education Book Group|"Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.~Scleroderma book"
11242289|NCT02494401|EG000|Reported Event|Internet-based Self-management Program|"Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.~Internet-based self-management program"
11242290|NCT02494401|EG001|Reported Event|Education Book Group|"Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.~Scleroderma book"
11242291|NCT02494440|BG000|Baseline|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
11242292|NCT02494440|FG000|Participant Flow|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
11242293|NCT02494440|OG000|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
11242294|NCT02494440|EG000|Reported Event|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
11242295|NCT02494518|BG000|Baseline|Forced Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Forced Exercise & Upper Extremity Repetitive Task Practice"
11199553|NCT02187159|EG000|Reported Event|Placebo|Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).
11199554|NCT02187159|EG001|Reported Event|Pregabalin 150 mg BID|Participants who received oral pregabalin 150 mg twice daily (BID).
11199555|NCT02187159|EG002|Reported Event|DS-5565 15 mg QD|Participants who received oral DS5565 15 mg once daily (QD).
11199556|NCT02187159|EG003|Reported Event|DS-5565 15 mg BID|Participants who received DS-5565 15 mg twice daily (BID).
11199557|NCT02187172|BG000|Baseline|Ustekinumab (Stelara)|"Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter.~Ustekinumab"
11199558|NCT02187172|BG001|Baseline|Placebo|"Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator.~Ustekinumab~Placebo"
11199559|NCT02187172|BG002|Baseline|Total|Total of all reporting groups
11199560|NCT02187172|FG000|Participant Flow|Ustekinumab|Randomized to receive Ustekinumab (Stelara) from day 0 until week 12 (randomized controlled trial (RCT) phase). Continue to receive ustekinumab for additional 40 weeks for a total of 52 weeks of ustekinumab. The end of study is at Week 52 for this arm.
11199561|NCT02187172|FG001|Participant Flow|Placebo|Randomized to receive Placebo from day 0 until week 12 (RCT phase). Receive ustekinumab from week 12 until week 64 for a total of 52 weeks of ustekinumab. The end of study is at Week 64 for this arm.
11199562|NCT02187172|OG000|Outcome|Ustekinumab (RCT Period)|Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.
11199563|NCT02187172|OG001|Outcome|Placebo (RCT Period)|Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.
11199564|NCT02187172|OG002|Outcome|Total (Active Treatment Period)|Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
11199565|NCT02187172|EG000|Reported Event|Ustekinumab (Stelara)|Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. From Baseline to Week 52.
11199566|NCT02187172|EG001|Reported Event|Placebo (RCT Period)|Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator. From Baseline to Week 12 (RCT period only).
11199567|NCT02187172|EG002|Reported Event|Placebo (Active Treatment Period)|Placebo arm after crossing over to receive ustekinumab, following the same dosing schedule of the Ustekinumab arm. From Week 12 to Week 64 (52 weeks of active treatment period).
11199568|NCT02187471|BG000|Baseline|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11199569|NCT02187471|BG001|Baseline|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11199570|NCT02187471|BG002|Baseline|DS-5565 15 mg QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11199571|NCT02187471|BG003|Baseline|DS-5565 15 mg BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11199572|NCT02187471|BG004|Baseline|Total|Total of all reporting groups
11199573|NCT02187471|FG000|Participant Flow|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11199574|NCT02187471|FG001|Participant Flow|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11199575|NCT02187471|FG002|Participant Flow|DS-5565 15 mg QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11199576|NCT02187471|FG003|Participant Flow|DS-5565 15 mg BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11199577|NCT02187471|OG000|Outcome|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11199578|NCT02187471|OG001|Outcome|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11199579|NCT02187471|OG002|Outcome|DS-5565 15 mg QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11199580|NCT02187471|OG003|Outcome|DS-5565 15 mg BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11199581|NCT02187471|OG001|Outcome|Pregabalin|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11199582|NCT02187471|EG000|Reported Event|Placebo|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and evening.
11199583|NCT02187471|EG001|Reported Event|Pregabalin 150 mg BID|Participants who received oral DS-5565 placebo and pregabalin 150 mg BID in the morning and evening.
11199584|NCT02187471|EG002|Reported Event|DS-5565 15 mg QD|Participants who received oral DS-5565 placebo and pregabalin placebo in the morning and DS-5565 15 mg and pregabalin placebo in the evening.
11199585|NCT02187471|EG003|Reported Event|DS-5565 15 mg BID|Participants who received oral DS-5565 15 mg and pregabalin placebo in the morning and evening.
11199586|NCT02187744|BG000|Baseline|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199587|NCT02187744|BG001|Baseline|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199588|NCT02187744|BG002|Baseline|Total|Total of all reporting groups
11199589|NCT02187744|FG000|Participant Flow|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.
11199590|NCT02187744|FG001|Participant Flow|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199591|NCT02187744|OG000|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199592|NCT02187744|OG001|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199593|NCT02187744|EG000|Reported Event|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
11199594|NCT02187744|EG001|Reported Event|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
10966105|NCT00885677|FG001|Participant Flow|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
11199595|NCT02187783|BG000|Baseline|Ribociclib 600 mg|LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
11199596|NCT02187783|FG000|Participant Flow|Ribociclib 600 mg|LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
11199597|NCT02187783|OG000|Outcome|Ribociclib 600 mg|LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
11199598|NCT02187783|EG000|Reported Event|Ribociclib 600 mg|LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
11199599|NCT02187809|BG000|Baseline|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
11199600|NCT02187809|FG000|Participant Flow|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
11199601|NCT02187809|OG000|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
11199602|NCT02187809|EG000|Reported Event|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
11199603|NCT02187861|BG000|Baseline|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199604|NCT02187861|BG001|Baseline|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
11199605|NCT02187861|BG002|Baseline|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199606|NCT02187861|BG003|Baseline|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199607|NCT02187861|BG004|Baseline|Total|Total of all reporting groups
11199608|NCT02187861|FG000|Participant Flow|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199609|NCT02187861|FG001|Participant Flow|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
11199610|NCT02187861|FG002|Participant Flow|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199611|NCT02187861|FG003|Participant Flow|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199612|NCT02187861|OG000|Outcome|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199613|NCT02187861|OG001|Outcome|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
11199614|NCT02187861|OG002|Outcome|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199615|NCT02187861|OG003|Outcome|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199616|NCT02187861|EG000|Reported Event|Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)|Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199617|NCT02187861|EG001|Reported Event|Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)|Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
10800257|NCT02213380|OG000|Outcome|Group RA|"Method of anesthesia: regional anesthesia~method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.~General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.~Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA"
11199618|NCT02187861|EG002|Reported Event|Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)|Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199619|NCT02187861|EG003|Reported Event|Chemotherapy-Containing Cohort: Arm C (BR)|Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
11199620|NCT02187887|BG000|Baseline|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
11199621|NCT02187887|BG001|Baseline|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
11199622|NCT02187887|BG002|Baseline|Total|Total of all reporting groups
11199623|NCT02187887|FG000|Participant Flow|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
11199624|NCT02187887|FG001|Participant Flow|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
11242296|NCT02494518|BG001|Baseline|Voluntary Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike at your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Voluntary Exercise & Upper Extremity Repetitive Task Practice"
11242297|NCT02494518|BG002|Baseline|Stroke Education & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of stroke education~45 minutes of upper extremity repetitive arm exercises~Stroke Education & Upper Extremity Repetitive Task Practice"
11242298|NCT02494518|BG003|Baseline|Total|Total of all reporting groups
11242299|NCT02494518|FG000|Participant Flow|Forced Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Forced Exercise & Upper Extremity Repetitive Task Practice"
11242300|NCT02494518|FG001|Participant Flow|Voluntary Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike at your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Voluntary Exercise & Upper Extremity Repetitive Task Practice"
11242301|NCT02494518|FG002|Participant Flow|Stroke Education & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of stroke education~45 minutes of upper extremity repetitive arm exercises~Stroke Education & Upper Extremity Repetitive Task Practice"
11242302|NCT02494518|OG000|Outcome|Forced Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Forced Exercise & Upper Extremity Repetitive Task Practice"
11242303|NCT02494518|OG001|Outcome|Voluntary Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike at your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Voluntary Exercise & Upper Extremity Repetitive Task Practice"
11242304|NCT02494518|OG002|Outcome|Stroke Education & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of stroke education~45 minutes of upper extremity repetitive arm exercises~Stroke Education & Upper Extremity Repetitive Task Practice"
11242305|NCT02494518|EG000|Reported Event|Forced Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Forced Exercise & Upper Extremity Repetitive Task Practice"
11242306|NCT02494518|EG001|Reported Event|Voluntary Exercise & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of cycling on a recumbent stationary bike at your self-selected speed~45 minutes of upper extremity repetitive arm exercises~Voluntary Exercise & Upper Extremity Repetitive Task Practice"
11242307|NCT02494518|EG002|Reported Event|Stroke Education & Upper Extremity Repetitive Task Practice|"Participants will perform the following:~45 minutes of stroke education~45 minutes of upper extremity repetitive arm exercises~Stroke Education & Upper Extremity Repetitive Task Practice"
11242308|NCT02494583|BG000|Baseline|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg IV Q3W.
11242309|NCT02494583|BG001|Baseline|Pembrolizumab + SOC Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242310|NCT02494583|BG002|Baseline|Placebo + SOC Chemotherapy (SOC)|Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242311|NCT02494583|BG003|Baseline|Total|Total of all reporting groups
11242312|NCT02494583|FG000|Participant Flow|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W)
11242313|NCT02494583|FG001|Participant Flow|Pembrolizumab + SOC Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242314|NCT02494583|FG002|Participant Flow|Placebo + SOC Chemotherapy (SOC)|Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242315|NCT02494583|OG000|Outcome|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg IV Q3W.
11242316|NCT02494583|OG001|Outcome|Pembrolizumab + SOC Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242317|NCT02494583|OG002|Outcome|Placebo + SOC Chemotherapy (SOC)|Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242318|NCT02494583|EG000|Reported Event|Pembrolizumab Monotherapy (Pembro Mono)|Participants received pembrolizumab 200 mg IV Q3W.
11242319|NCT02494583|EG001|Reported Event|Pembrolizumab + SOC Chemotherapy (Pembro Combo)|Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
11242320|NCT02494583|EG002|Reported Event|Placebo + SOC Chemotherapy (SOC)|Participants received placebo IV Q3W plus cisplatin 80 mg/m^2 Q3W plus 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
10800258|NCT02213380|OG001|Outcome|Group GA|"Method of anesthesia: general anesthesia~method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.~General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.~Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA"
11242321|NCT02494596|BG000|Baseline|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242322|NCT02494596|FG000|Participant Flow|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242323|NCT02494596|FG001|Participant Flow|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242324|NCT02494596|FG002|Participant Flow|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242325|NCT02494596|OG000|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242326|NCT02494596|OG000|Outcome|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242327|NCT02494596|OG001|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242328|NCT02494596|OG002|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242329|NCT02494596|OG000|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242330|NCT02494596|OG000|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242331|NCT02494596|EG000|Reported Event|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242332|NCT02494596|EG001|Reported Event|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242333|NCT02494596|EG002|Reported Event|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
11242334|NCT02494713|BG000|Baseline|ADT + Chemotherapy|"Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.~Degarelix: Subcutaneous injection, once/month for 4 months~Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5~Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5~Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6~Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6"
11340891|NCT03669081|OG001|Outcome|Placebo and Standard of Care|"Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.~Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation.~Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively."
11242335|NCT02494713|FG000|Participant Flow|ADT + Chemotherapy|"Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.~Degarelix: Subcutaneous injection, once/month for 4 months~Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5~Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5~Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6~Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6"
11242336|NCT02494713|OG000|Outcome|ADT + Chemotherapy|"Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.~Degarelix: Subcutaneous injection, once/month for 4 months~Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5~Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5~Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6~Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6"
11242337|NCT02494713|EG000|Reported Event|ADT + Chemotherapy|"Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.~Degarelix: Subcutaneous injection, once/month for 4 months~Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5~Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5~Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6~Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6"
11242338|NCT02494778|BG000|Baseline|Pridopidine 45 mg BID|Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
11242339|NCT02494778|FG000|Participant Flow|Pridopidine 45 mg BID|Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
11242340|NCT02494778|OG000|Outcome|Pridopidine 45 mg BID|Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
11242341|NCT02494778|EG000|Reported Event|Pridopidine 45 mg BID|Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
11242342|NCT02494817|BG000|Baseline|Control Group|Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
11242343|NCT02494817|BG001|Baseline|Intervention Group|Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
11242344|NCT02494817|BG002|Baseline|Total|Total of all reporting groups
11242345|NCT02494817|FG000|Participant Flow|Control Group|Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
11242346|NCT02494817|FG001|Participant Flow|Intervention Group|Couples assigned to the intervention group will first, as individuals, view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
11242347|NCT02494817|OG000|Outcome|Control Group|Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
11242348|NCT02494817|OG001|Outcome|Intervention Group|Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
10800259|NCT02213380|EG000|Reported Event|Group RA|"Method of anesthesia: regional anesthesia~method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.~General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.~Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA"
11242349|NCT02494817|EG000|Reported Event|Control Group|Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
11242350|NCT02494817|EG001|Reported Event|Intervention Group|Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
11242351|NCT02495025|BG000|Baseline|Telephone-based Screening|"Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone. Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT). If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services. A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.~Telephone-based developmental screening and care coordination"
11242352|NCT02495025|BG001|Baseline|Usual Care|Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination. Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
11242353|NCT02495025|BG002|Baseline|Total|Total of all reporting groups
11242354|NCT02495025|FG000|Participant Flow|Telephone-based Screening|"Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone. Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT). If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services. A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.~Telephone-based developmental screening and care coordination"
11242355|NCT02495025|FG001|Participant Flow|Usual Care|Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination. Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
11242356|NCT02495025|OG000|Outcome|Telephone-based Screening|"Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone. Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT). If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services. A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.~Telephone-based developmental screening and care coordination"
11242357|NCT02495025|OG001|Outcome|Usual Care|Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination. Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
11242358|NCT02495025|EG000|Reported Event|Telephone-based Screening|"Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone. Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT). If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services. A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.~Telephone-based developmental screening and care coordination"
11242359|NCT02495025|EG001|Reported Event|Usual Care|Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination. Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
11242360|NCT02495038|BG000|Baseline|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
11338986|NCT03621787|EG000|Reported Event|Single Arm Study: Implant Insertion|"Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire will assess bruising and infection risk. A final visit will assess bruising and infection risk by a physician.~Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately."
10800260|NCT02213380|EG001|Reported Event|Group GA|"Method of anesthesia: general anesthesia~method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.~General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.~Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA"
10800261|NCT02184195|BG000|Baseline|Olaparib 300 mg Twice Daily (bd)|Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
11338987|NCT03621878|BG000|Baseline|Control Group|"patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338988|NCT03621878|BG001|Baseline|Tensioner Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.~Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338989|NCT03621878|BG002|Baseline|Slider Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.~Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338990|NCT03621878|BG003|Baseline|Total|Total of all reporting groups
11338991|NCT03621878|FG000|Participant Flow|Control Group|"patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338992|NCT03621878|FG001|Participant Flow|Tensioner Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.~Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338993|NCT03621878|FG002|Participant Flow|Slider Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.~Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338994|NCT03621878|OG000|Outcome|Control Group|"patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338995|NCT03621878|OG001|Outcome|Slider Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.~Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338996|NCT03621878|OG002|Outcome|Tensioner Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.~Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338997|NCT03621878|EG000|Reported Event|Control Group|"patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338998|NCT03621878|EG001|Reported Event|Tensioner Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.~Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11338999|NCT03621878|EG002|Reported Event|Slider Group|"patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.~Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures~Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management"
11339000|NCT03622112|BG000|Baseline|AZD7594 50 μg|Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily.
11339001|NCT03622112|BG001|Baseline|AZD7594 90 μg|Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily.
11339002|NCT03622112|BG002|Baseline|AZD7594 180 μg|Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
11339003|NCT03622112|BG003|Baseline|AZD7594 360 μg|Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
11339004|NCT03622112|BG004|Baseline|AZD7594 720 μg|Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily.
11339005|NCT03622112|BG005|Baseline|Placebo to AZD7594|Oral inhalation of placebo to AZD7594 once daily.
11339006|NCT03622112|BG006|Baseline|Fluticasone Furoate|Oral inhalation of fluticasone furoate 100 microgram once daily.
11339007|NCT03622112|BG007|Baseline|Total|Total of all reporting groups
11339008|NCT03622112|FG000|Participant Flow|AZD7594 50 μg|Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily.
11339009|NCT03622112|FG001|Participant Flow|AZD7594 90 μg|Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily.
11339010|NCT03622112|FG002|Participant Flow|AZD7594 180 μg|Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
11339011|NCT03622112|FG003|Participant Flow|AZD7594 360 μg|Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
11339012|NCT03622112|FG004|Participant Flow|AZD7594 720 μg|Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily.
11339013|NCT03622112|FG005|Participant Flow|Placebo to AZD7594|Oral inhalation of placebo to AZD7594 once daily.
11339014|NCT03622112|FG006|Participant Flow|Fluticasone Furoate|Oral inhalation of fluticasone furoate 100 microgram once daily.
11339015|NCT03622112|OG000|Outcome|AZD7594 50 μg|Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily.
11339016|NCT03622112|OG001|Outcome|AZD7594 90 μg|Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily.
10966106|NCT00885677|OG000|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
10966107|NCT00885677|OG001|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
11339017|NCT03622112|OG002|Outcome|AZD7594 180 μg|Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
11339018|NCT03622112|OG003|Outcome|AZD7594 360 μg|Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
11339019|NCT03622112|OG004|Outcome|AZD7594 720 μg|Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily.
11339020|NCT03622112|OG005|Outcome|Placebo to AZD7594|Oral inhalation of placebo to AZD7594 once daily.
11339021|NCT03622112|OG006|Outcome|Fluticasone Furoate|Oral inhalation of fluticasone furoate 100 microgram once daily.
11339022|NCT03622112|EG000|Reported Event|AZD7594 50 μg|Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily.
11339023|NCT03622112|EG001|Reported Event|AZD7594 90 μg|Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily.
11339024|NCT03622112|EG002|Reported Event|AZD7594 180 μg|Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
11339025|NCT03622112|EG003|Reported Event|AZD7594 360 μg|Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
11339026|NCT03622112|EG004|Reported Event|AZD7594 720 μg|Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily.
11339027|NCT03622112|EG005|Reported Event|Placebo to AZD7594|Oral inhalation of placebo to AZD7594 once daily.
11339028|NCT03622112|EG006|Reported Event|Fluticasone Furoate|Oral inhalation of fluticasone furoate 100 microgram once daily.
11339029|NCT03622619|BG000|Baseline|Manuka Eye Drops|Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
11339030|NCT03622619|BG001|Baseline|Systane Ultra|Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
11339031|NCT03622619|BG002|Baseline|Total|Total of all reporting groups
11339032|NCT03622619|FG000|Participant Flow|Manuka Eye Drops|Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
11339033|NCT03622619|FG001|Participant Flow|Systane Ultra|Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
11339034|NCT03622619|OG000|Outcome|Manuka Eye Drops|Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
11339035|NCT03622619|OG001|Outcome|Systane Ultra|Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
11339036|NCT03622619|EG000|Reported Event|Manuka Eye Drops|Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
11339037|NCT03622619|EG001|Reported Event|Systane Ultra|Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
11339038|NCT03623035|BG000|Baseline|Lumbar Plexus Block Group|This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
11339039|NCT03623035|FG000|Participant Flow|Lumbar Plexus Block Group|This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
11339040|NCT03623035|OG000|Outcome|Lumbar Plexus Block Group|This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
11339041|NCT03623035|EG000|Reported Event|Lumbar Plexus Block Group|This group includes participants that received Lumbar Plexus blocks (LPB) as the regional analgesic technique in a direct anterior approach (DAA) Total Hip Arthroplasty.
11339042|NCT03623334|BG000|Baseline|Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50Gy)|Image-guided radiation therapy (IGRT) does of 3.33Gy for 15 fractions (total dose = 50 Gy) which is given over the course of about 3 weeks
11339043|NCT03623334|BG001|Baseline|Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55Gy)|Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 55 Gy) which is given over the course of about 3 weeks
11339044|NCT03623334|BG002|Baseline|Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy)|"4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks~Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy."
11339045|NCT03623334|BG003|Baseline|Total|Total of all reporting groups
11339046|NCT03623334|FG000|Participant Flow|Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50 Gy)|"Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks~Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy."
11339047|NCT03623334|FG001|Participant Flow|Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55-Gy )|"Image-guided radiation therapy (IGRT) which is given over the course of about 3 weeks~Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy."
10800262|NCT02184195|BG001|Baseline|Placebo|Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
10800263|NCT02184195|BG002|Baseline|Total|Total of all reporting groups
10800264|NCT02184195|FG000|Participant Flow|Olaparib 300 mg Twice Daily (bd)|Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
10800265|NCT02184195|FG001|Participant Flow|Placebo|Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
11199625|NCT02187887|OG000|Outcome|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
11199626|NCT02187887|OG001|Outcome|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
11199627|NCT02187887|EG000|Reported Event|Personalized Normative Feedback|"Intervention participants receive feedback correcting their misperceptions of the drinking behavior and attitudes of fellow veterans~Personalized normative feedback: Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans."
11199628|NCT02187887|EG001|Reported Event|Control|Control participants receive feedback correcting their misperceptions of the video game playing behavior and attitudes of fellow veterans
11199629|NCT02188160|BG000|Baseline|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease~KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11199630|NCT02188160|BG001|Baseline|Vehicle|"Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease~Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11199631|NCT02188160|BG002|Baseline|Total|Total of all reporting groups
11199632|NCT02188160|FG000|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease~KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11199633|NCT02188160|FG001|Participant Flow|Vehicle|"Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease~Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11199634|NCT02188160|OG000|Outcome|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease~KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11199635|NCT02188160|OG001|Outcome|Vehicle|"Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease~Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11199636|NCT02188160|EG000|Reported Event|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease~KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11199637|NCT02188160|EG001|Reported Event|Vehicle|"Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease~Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11199638|NCT02188303|BG000|Baseline|Part A / Cohorts 1-3 - Placebo|Placebo, Single Dose Administered SC
11199639|NCT02188303|BG001|Baseline|Part A / Cohort 1 - 10 mg LY2944876|LY2944876 10 mg, Single Dose Administered SC
11199640|NCT02188303|BG002|Baseline|Part A / Cohort 2 - 30 mg LY2944876|LY2944876 30 mg, Single Dose Administered SC
11199641|NCT02188303|BG003|Baseline|Part A / Cohort 3 - 50 mg LY2944876|LY2944876 50 mg, Single Dose Administered SC
11199642|NCT02188303|BG004|Baseline|Part B / Cohort 4 - Placebo|Placebo Administered QD SC, Days 1-7
11199643|NCT02188303|BG005|Baseline|Part B / Cohort 4 - 40 mg LY2944876|LY2944876 40 mg, Administered QD SC, Days 1-7
11199644|NCT02188303|BG006|Baseline|Part B / Cohort 5 - Placebo|Placebo, Administered QD SC, Days 1, 4 and 6.
11199645|NCT02188303|BG007|Baseline|Part B / Cohort 5 - 15-60 mg Titrated LY2944876|LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
11199646|NCT02188303|BG008|Baseline|Total|Total of all reporting groups
11199647|NCT02188303|FG000|Participant Flow|Part A / Cohorts 1-3 - Placebo|Placebo, Single Dose Administered Subcutaneously (SC) on Day 1
11199648|NCT02188303|FG001|Participant Flow|Part A / Cohort 1 - 10 mg LY2944876|10 milligram (mg) LY2944876, Single Dose Administered SC on Day 1
11199649|NCT02188303|FG002|Participant Flow|Part A / Cohort 2 - 30 mg LY2944876|30 mg LY2944876, Single Dose Administered SC on Day 1
11199650|NCT02188303|FG003|Participant Flow|Part A / Cohort 3 - 50 mg LY2944876|50 mg LY2944876, Single Dose Administered SC on Day 1
11199651|NCT02188303|FG004|Participant Flow|Part B / Cohort 4 - Placebo|Placebo Administered Once Daily (QD) SC, Days 1-7
11199652|NCT02188303|FG005|Participant Flow|Part B / Cohort 4 - 40 mg LY2944876|40 mg LY2944876 Administered QD SC, Days 1-7
11199653|NCT02188303|FG006|Participant Flow|Part B / Cohort 5 - Placebo|Placebo Administered QD SC, Day 1, 4 and 6.
11199654|NCT02188303|FG007|Participant Flow|Part B / Cohort 5 - 15-60 mg Titrated LY2944876|LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
11339048|NCT03623334|FG002|Participant Flow|Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy)|"4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks~Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy."
11339049|NCT03623334|OG000|Outcome|Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)|In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
11339050|NCT03623334|OG001|Outcome|Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)|In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
11339051|NCT03623334|OG002|Outcome|Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)|In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
11339052|NCT03623334|EG000|Reported Event|Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)|
11339053|NCT03623334|EG001|Reported Event|Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)|
11339054|NCT03623334|EG002|Reported Event|Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy|
11339055|NCT03623698|BG000|Baseline|Children and Young People With Neuromuscular Disease|Children and young people with neuromuscular disease before nebulised saline was prescribed to them.
11339056|NCT03623698|FG000|Participant Flow|Children and Young People With Neuromuscular Disease|Children and young people with neuromuscular disease 18 years old or younger, who had been at least 12 months on prescribed nebulised saline (0.9%, 3%, 6%, and/or 7%) between 2011 and 2019.
11339057|NCT03623698|OG000|Outcome|Before Treatment|Children and young people with neuromuscular disease during the 12 months before being prescribed treatment with nebulised saline
11339058|NCT03623698|OG001|Outcome|After Treatment|Children and young people with neuromuscular disease during the 12 months after being prescribed treatment with nebulised saline (0.9%, 3%, 6%, and/or 7%)
11339059|NCT03623698|OG000|Outcome|Children and Young People With Neuromuscular Disease|Children and young people with neuromuscular disease 18 years old or younger, who had been at least 12 months on prescribed nebulised saline (0.9%, 3%, 6%, and/or 7%) between 2011 and 2019.
11339060|NCT03623698|OG000|Outcome|Parent's or Legal Guardians|One parent or legal guardian for each of the study participants
11339061|NCT03623698|OG000|Outcome|Before Treatment|Children and young people with neuromuscular disease during the 12 months before being prescribed treatment with nebulised saline (0.9% - 7%)
11339062|NCT03623698|OG001|Outcome|After Treatment|Children and young people with neuromuscular disease during the 12 months after being prescribed treatment with nebulised saline (0.9% - 7%)
11339063|NCT03623698|OG000|Outcome|Before Treatment|Parents of children and young people with neuromuscular disease during the 12 months before being prescribed treatment with nebulised saline (0.9% - 7%)
11339064|NCT03623698|OG001|Outcome|After Treatment|Parents pf children and young people with neuromuscular disease during the 12 months after being prescribed treatment with nebulised saline (0.9% - 7%)
11339065|NCT03623698|EG000|Reported Event|Children and Young People With Neuromuscular Disease|Children and young people with neuromuscular disease 18 years old or younger, who had been at least 12 months on prescribed nebulised saline (0.9%, 3%, 6%, and/or 7%) between 2011 and 2019.
11339066|NCT03624192|BG000|Baseline|Experimental: All Participants (Within Patient Control)|All subjects receive both RECELL and Control. Each subject serves as their own control.
11339067|NCT03624192|FG000|Participant Flow|RECELL|"Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.~RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
11339068|NCT03624192|FG001|Participant Flow|Control|"very subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.~RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
11339069|NCT03624192|OG000|Outcome|RECELL|"Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.~RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
11339070|NCT03624192|OG001|Outcome|Control|"Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.~RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
11339071|NCT03624192|OG000|Outcome|All Participants|"Treatment: RECELL + Telfa™ Clear and Xeroform™ dressings. RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Control: Telfa and Xeroform only"
11339072|NCT03624192|OG000|Outcome|RECELL® Autologous Cell Harvesting Device|"RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings"
11339073|NCT03624192|OG001|Outcome|Telfa™ Clear and Xeroform™ Dressings|"Telfa™ Clear and Xeroform™ dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
10800266|NCT02184195|OG000|Outcome|Olaparib 300 mg Twice Daily (bd)|Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
10800267|NCT02184195|OG001|Outcome|Placebo|Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
11199655|NCT02188303|OG000|Outcome|Cohorts 1-3 - Placebo|Placebo, Single Dose Administered SC
11199656|NCT02188303|OG001|Outcome|Cohort 1 - 10 mg LY2944876|10 mg LY2944876, Single Dose Administered SC
11199657|NCT02188303|OG002|Outcome|Cohort 2 - 30 mg LY2944876|30 mg LY2944876, Single Dose Administered SC
11199658|NCT02188303|OG003|Outcome|Cohort 3 - 50 mg LY2944876|50 mg LY2944876, Single Dose Administered SC
11199659|NCT02188303|OG004|Outcome|Cohort 4 - Placebo|Placebo Administered QD SC, Days 1-7
11199660|NCT02188303|OG005|Outcome|Cohort 4 - 40 mg LY2944876|40 mg LY2944876 Administered QD SC, Days 1-7
11199661|NCT02188303|OG006|Outcome|Cohort 5 - Placebo|Placebo Administered QD SC, Day 1, Day 4 and Day 6.
11199662|NCT02188303|OG007|Outcome|Cohort 5 - 15-60 mg Titrated LY2944876|LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
11199663|NCT02188303|OG000|Outcome|Cohort 1 - 10 mg LY2944876|10 mg LY2944876, Single Dose Administered SC
11199664|NCT02188303|OG001|Outcome|Cohort 2 - 30 mg LY2944876|30 mg LY2944876, Single Dose Administered SC
11199665|NCT02188303|OG002|Outcome|Cohort 3 - 50 mg LY2944876|50 mg LY2944876, Single Dose Administered SC
11199666|NCT02188303|OG003|Outcome|Cohort 4 - 40 mg LY2944876|40 mg LY2944876 Administered QD SC, Day 7
11199667|NCT02188303|OG004|Outcome|Cohort 5 - 15-60 mg Titrated LY2944876|LY2944876 Administered QD SC, titrated up to 60 mg on Day 6
11199668|NCT02188303|OG002|Outcome|Cohort 3 - LY2944876 50 mg|50 mg LY2944876, Single Dose Administered SC
11199669|NCT02188303|EG000|Reported Event|Cohorts 1-3 - Placebo|Placebo, Single Dose Administered Subcutaneously (SC)
10800268|NCT02184195|EG000|Reported Event|Olaparib 300 mg Twice Daily (bd)|Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
10800269|NCT02184195|EG001|Reported Event|Placebo|Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
11199670|NCT02188303|EG001|Reported Event|Cohort 1 - LY2944876 10 mg|LY2944876 10 mg, Single Dose Administered SC
11199671|NCT02188303|EG002|Reported Event|Cohort 2 - LY2944876 30 mg|LY2944876 30 mg, Single Dose Administered SC
11199672|NCT02188303|EG003|Reported Event|Cohort 3 - LY2944876 50 mg|LY2944876 50 mg, Single Dose Administered SC
10800270|NCT02113592|BG000|Baseline|Cognitive Behavioral Therapy (CBT) Intervention|Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
11199673|NCT02188303|EG004|Reported Event|Cohort 4 - Placebo|Placebo Administered QD SC, Days 1-7
11199674|NCT02188303|EG005|Reported Event|Cohort 4 - LY2944876 40 mg|LY2944876 40 mg Administered QD SC, Days 1-7
11199675|NCT02188303|EG006|Reported Event|Cohort 5 - Placebo|Placebo Administered QD SC, Day 1, Day 4, and Day 6.
11199676|NCT02188303|EG007|Reported Event|Cohort 5 - 15-80 mg Titrated LY2944876|LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
11199677|NCT02188459|BG000|Baseline|Placebo|Placebo BID, PO for 10 weeks.
11199678|NCT02188459|BG001|Baseline|Bupropion|Bupropion 150 mg BID, PO for 10 weeks
11199679|NCT02188459|BG002|Baseline|Total|Total of all reporting groups
11199680|NCT02188459|FG000|Participant Flow|Bupropion|"Bupropion 150 mg BID, PO for 10 weeks~Bupropion: A total of 360 participants will be randomly assigned to one of two treatment conditions: Bupropion 300 mg/day (n = 180) or placebo (n = 180). We will use small-block randomization by site (Penn). A PHQ-9 score of 10 or greater will be used to identify major depression and stratify the randomization on it. Study site (Penn) will be the second of the two stratification variables."
11199681|NCT02188459|FG001|Participant Flow|Placebo|"Placebo BID, PO for 10 weeks. The formulation appears identical to the bupropion capsules.~Bupropion: A total of 360 participants will be randomly assigned to one of two treatment conditions: Bupropion 300 mg/day (n = 180) or placebo (n = 180). We will use small-block randomization by site (Penn). A PHQ-9 score of 10 or greater will be used to identify major depression and stratify the randomization on it. Study site (Penn) will be the second of the two stratification variables."
11199682|NCT02188459|OG000|Outcome|Placebo Group|10 mg placebo daily 10 weeks
11199683|NCT02188459|OG001|Outcome|Bupropion Group|10 mg buproprion 10 weeks
11199684|NCT02188459|OG000|Outcome|Placebo|Placebo BID, PO for 10 weeks.
11199685|NCT02188459|OG001|Outcome|Bupropion|Bupropion 150 mg BID, PO for 10 weeks
11199686|NCT02188459|OG000|Outcome|Bupropion|Bupropion 150 mg BID, PO for 10 weeks
11199687|NCT02188459|OG001|Outcome|Placebo|Placebo BID, PO for 10 weeks.
11199688|NCT02188459|EG000|Reported Event|Placebo|Placebo BID, PO for 10 weeks.
11199689|NCT02188459|EG001|Reported Event|Bupropion|Bupropion 150 mg BID, PO for 10 weeks
11199690|NCT02188485|BG000|Baseline|ENGAGE: a Social Engagement Intervention|"ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).~ENGAGE: Up to 10 sessions delivered in the home."
11199691|NCT02188485|BG001|Baseline|Care-as-Usual|Care as usual in primary care with study assessments.
11199692|NCT02188485|BG002|Baseline|Total|Total of all reporting groups
11199693|NCT02188485|FG000|Participant Flow|ENGAGE: a Social Engagement Intervention|"ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).~ENGAGE: Up to 10 sessions delivered in the home."
11199694|NCT02188485|FG001|Participant Flow|Care-as-Usual|Care as usual in primary care with study assessments.
11199695|NCT02188485|OG000|Outcome|ENGAGE: a Social Engagement Intervention|"ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).~ENGAGE: Up to 10 sessions delivered in the home."
11199696|NCT02188485|OG001|Outcome|Care-as-Usual|Care as usual in primary care with study assessments.
11199697|NCT02188485|EG000|Reported Event|ENGAGE: a Social Engagement Intervention|"ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).~ENGAGE: Up to 10 sessions delivered in the home."
11199698|NCT02188485|EG001|Reported Event|Care-as-Usual|Care as usual in primary care with study assessments.
11199699|NCT02188576|BG000|Baseline|High Dose TXA|"High dose TXA is the intervention.~A higher dose of tranexamic acid will be given to this arm as follows:~50 mg/kg loading dose and 5 mg/kg/h infusion~high dose TXA"
11199700|NCT02188576|BG001|Baseline|Low Dose TXA|"Low dose TXA is the intervention.~A lower dose of TXa will be given as follows:~10 mg/kg loading dose and 5 mg/kg/h infusion~Low dose TXA"
11199701|NCT02188576|BG002|Baseline|Total|Total of all reporting groups
11199702|NCT02188576|FG000|Participant Flow|High Dose TXA|"High dose TXA is the intervention.~A higher dose of tranexamic acid will be given to this arm as follows:~50 mg/kg loading dose and 5 mg/kg/h infusion~high dose TXA"
11199703|NCT02188576|FG001|Participant Flow|Low Dose TXA|"Low dose TXA is the intervention.~A lower dose of TXa will be given as follows:~10 mg/kg loading dose and 5 mg/kg/h infusion~Low dose TXA"
11199704|NCT02188576|OG000|Outcome|High Dose TXA|"High dose TXA is the intervention.~A higher dose of tranexamic acid will be given to this arm as follows:~50 mg/kg loading dose and 5 mg/kg/h infusion~high dose TXA~Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery."
11199705|NCT02188576|OG001|Outcome|Low Dose TXA|"Low dose TXA is the intervention.~A lower dose of TXa will be given as follows:~10 mg/kg loading dose and 5 mg/kg/h infusion~Low dose TXA~Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery."
11199706|NCT02188576|EG000|Reported Event|High Dose TXA|"High dose TXA is the intervention.~A higher dose of tranexamic acid will be given to this arm as follows:~50 mg/kg loading dose and 5 mg/kg/h infusion~high dose TXA"
11199707|NCT02188576|EG001|Reported Event|Low Dose TXA|"Low dose TXA is the intervention.~A lower dose of TXa will be given as follows:~10 mg/kg loading dose and 5 mg/kg/h infusion~Low dose TXA"
11199708|NCT02188589|BG000|Baseline|Treatment Group|Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
11199709|NCT02188589|FG000|Participant Flow|Treatment Group|Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
11342574|NCT03710083|OG000|Outcome|Study Arm|"Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7).~Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days."
10800271|NCT02113592|BG001|Baseline|Usual Care|Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
10800272|NCT02113592|BG002|Baseline|Total|Total of all reporting groups
11342575|NCT03710083|EG000|Reported Event|Study Arm|"Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7).~Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days."
11342576|NCT03710161|BG000|Baseline|4000 IU Vitamin D|"4000 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342577|NCT03710161|BG001|Baseline|800 IU Vitamin D|"800 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342578|NCT03710161|BG002|Baseline|Total|Total of all reporting groups
11342579|NCT03710161|FG000|Participant Flow|4000 IU Vitamin D|"4000 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342580|NCT03710161|FG001|Participant Flow|800 IU Vitamin D|"800 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342581|NCT03710161|OG000|Outcome|4000 IU Vitamin D|"4000 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342582|NCT03710161|OG001|Outcome|800 IU Vitamin D|"800 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342583|NCT03710161|EG000|Reported Event|4000 IU Vitamin D|"4000 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342584|NCT03710161|EG001|Reported Event|800 IU Vitamin D|"800 IU Vitamin D taken daily for six months~Vitamin D: Vitamin D taken in two different dosages daily for six months."
11342585|NCT03710187|BG000|Baseline|Combination|"Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h~Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h"
11342586|NCT03710187|BG001|Baseline|Hydrocortisone Only|"Hydrocortisone 50 mg IV Q6h~Hydrocortisone: Hydrocortisone 50 mg IV Q6h"
11342587|NCT03710187|BG002|Baseline|Total|Total of all reporting groups
11342588|NCT03710187|FG000|Participant Flow|Combination|Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h
11342589|NCT03710187|FG001|Participant Flow|Hydrocortisone Only|Hydrocortisone 50 mg IV Q6h
11342590|NCT03710187|OG000|Outcome|Combination|"Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h~Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h"
11342591|NCT03710187|OG001|Outcome|Hydrocortisone Only|"Hydrocortisone 50 mg IV Q6h~Hydrocortisone: Hydrocortisone 50 mg IV Q6h"
11342592|NCT03710187|EG000|Reported Event|Combination|"Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h~Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h"
11342593|NCT03710187|EG001|Reported Event|Hydrocortisone Only|"Hydrocortisone 50 mg IV Q6h~Hydrocortisone: Hydrocortisone 50 mg IV Q6h"
11342594|NCT03710577|BG000|Baseline|Yoga, the Quiet Rest|"40 minutes of Vinyasa yoga Yoga: 1 session~2-5 days between sessions~40 minutes of Quiet Rest Quiet Rest: 1 session"
11342595|NCT03710577|BG001|Baseline|Quiet Rest, Then Yoga|"40 minutes of quiet rest Quiet Rest: 1 session~2-5 days between sessions~40 minutes of Yoga Yoga: 1 session"
11342596|NCT03710577|BG002|Baseline|Total|Total of all reporting groups
11342597|NCT03710577|FG000|Participant Flow|Yoga, Then Quiet Rest|"40 minutes of Vinyasa yoga Yoga: 1 session~2-5 days between sessions~40 minutes of quiet rest Quiet Rest: 1 session"
11342598|NCT03710577|FG001|Participant Flow|Quiet Rest, Then Yoga|"40 minutes of quiet rest Quiet Rest: 1 session~2-5 days between sessions~40 minutes of Yoga Yoga: 1 session"
11342599|NCT03710577|OG000|Outcome|Yoga|"40 minutes of Vinyasa yoga~Yoga: 1 session"
11342600|NCT03710577|OG001|Outcome|Quiet Rest|"40 minutes of quiet rest~Quiet Rest: 1 session"
11342601|NCT03710577|EG000|Reported Event|Yoga|"40 minutes of Vinyasa yoga~Yoga: 1 session"
11342602|NCT03710577|EG001|Reported Event|Quiet Rest|"40 minutes of quiet rest~Quiet Rest: 1 session"
11342603|NCT03710590|BG000|Baseline|Cigarette Smokers|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342604|NCT03710590|BG001|Baseline|E-cigarette Users|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342605|NCT03710590|BG002|Baseline|Total|Total of all reporting groups
11342606|NCT03710590|FG000|Participant Flow|Cigarette Smokers|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11199710|NCT02188589|OG000|Outcome|Treatment Group|Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
11199711|NCT02188589|OG000|Outcome|Nasal Implant Group|Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
11199712|NCT02188589|EG000|Reported Event|Treatment Group|Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
10800273|NCT02113592|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT) Intervention|Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
10800274|NCT02113592|FG001|Participant Flow|Usual Care|Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
10800275|NCT02113592|OG000|Outcome|Cognitive Behavioral Therapy (CBT) Intervention|Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
10800276|NCT02113592|OG001|Outcome|Usual Care|Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
10800277|NCT02113592|EG000|Reported Event|Cognitive Behavioral Therapy (CBT) Intervention|Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
10800278|NCT02113592|EG001|Reported Event|Usual Care|Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
11199713|NCT02188719|BG000|Baseline|Cohort 1|Participants received Thymoglobulin®+EVR IS but will not receive darTregs
11199714|NCT02188719|BG001|Baseline|Cohort 2|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
11199715|NCT02188719|BG002|Baseline|Cohort 3|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
11199716|NCT02188719|BG003|Baseline|Cohort 4|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
11199717|NCT02188719|BG004|Baseline|Total|Total of all reporting groups
11199718|NCT02188719|FG000|Participant Flow|Cohort 1|Participants received Thymoglobulin®+EVR IS but will not receive darTregs
11199719|NCT02188719|FG001|Participant Flow|Cohort 2|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
11199720|NCT02188719|FG002|Participant Flow|Cohort 3|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
11199721|NCT02188719|FG003|Participant Flow|Cohort 4|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
11199722|NCT02188719|OG000|Outcome|Cohort 1|Participants received Thymoglobulin®+EVR IS but will not receive darTregs
11199723|NCT02188719|OG001|Outcome|Cohort 2|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
11199724|NCT02188719|OG002|Outcome|Cohort 3|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
11199725|NCT02188719|OG003|Outcome|Cohort 4|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
11199726|NCT02188719|EG000|Reported Event|Cohort 1|Participants received Thymoglobulin® +EVR IS but will not receive darTregs
11199727|NCT02188719|EG001|Reported Event|Cohort 2|Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
11199728|NCT02188784|BG000|Baseline|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
11199729|NCT02188784|BG001|Baseline|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
11199730|NCT02188784|BG002|Baseline|Total|Total of all reporting groups
11199731|NCT02188784|FG000|Participant Flow|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
11199732|NCT02188784|FG001|Participant Flow|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
11199733|NCT02188784|OG000|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
11199734|NCT02188784|OG001|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
11199735|NCT02188784|EG000|Reported Event|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
11199736|NCT02188784|EG001|Reported Event|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
11199737|NCT02188849|BG000|Baseline|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
11199738|NCT02188849|BG001|Baseline|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
11199739|NCT02188849|BG002|Baseline|Total|Total of all reporting groups
11199740|NCT02188849|FG000|Participant Flow|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
10800279|NCT02089685|BG000|Baseline|Part 1A Pembrolizumab + IPI 1 mg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199741|NCT02188849|FG001|Participant Flow|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
11199742|NCT02188849|OG000|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
11199743|NCT02188849|OG001|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
11199744|NCT02188849|EG000|Reported Event|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
11199745|NCT02188849|EG001|Reported Event|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
11199746|NCT02189122|BG000|Baseline|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
11199747|NCT02189122|BG001|Baseline|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
11199748|NCT02189122|BG002|Baseline|Total|Total of all reporting groups
11199749|NCT02189122|FG000|Participant Flow|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg."
11199750|NCT02189122|FG001|Participant Flow|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg."
11199751|NCT02189122|OG000|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
11199752|NCT02189122|OG001|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
11199753|NCT02189122|OG000|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
11199754|NCT02189122|OG001|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
11199755|NCT02189122|EG000|Reported Event|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
11199756|NCT02189122|EG001|Reported Event|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
11199757|NCT02189161|BG000|Baseline|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
11199758|NCT02189161|FG000|Participant Flow|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
11199759|NCT02189161|OG000|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
11199760|NCT02189161|EG000|Reported Event|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
11199761|NCT02189213|BG000|Baseline|Sertraline|"Sertraline will be administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:~Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or the titration will stop at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration."
11199762|NCT02189213|BG001|Baseline|Control|There will be no intervention in this arm.
11199763|NCT02189213|BG002|Baseline|Total|Total of all reporting groups
11199764|NCT02189213|FG000|Participant Flow|Sertraline|"Sertraline was administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:~Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or, the titration was stopped at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration."
11199765|NCT02189213|FG001|Participant Flow|Healthy Control|Healthy control will not be treated.
11199766|NCT02189213|OG000|Outcome|Sertraline Responders|"Responders will have either a score of 1 or 2 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.~The following one query is rated on a seven-point scale: Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment."
11199767|NCT02189213|OG001|Outcome|Sertraline Non-Responders|"Non-Responders will have a score of 3 or greater than 3 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.~The following one query is rated on a seven-point scale: Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment."
11199768|NCT02189213|EG000|Reported Event|Sertraline|"Sertraline was administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:~Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or, the titration was stopped at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration."
11199769|NCT02189213|EG001|Reported Event|Healthy Control|Healthy control will not be treated.
10800280|NCT02089685|BG001|Baseline|Part 1A Pembrolizumab + Pegylated Interferon Alfa-2b (PEG-IFN) 1 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg SC once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
10800281|NCT02089685|BG002|Baseline|Part 1A Pembrolizumab + PEG-IFN 2 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 2 µg/kg SC once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
11199770|NCT02189252|BG000|Baseline|Treatment Sequence 1|Epanova 4 g per day:Lovaza 4 g per day
11199771|NCT02189252|BG001|Baseline|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
11199772|NCT02189252|BG002|Baseline|Treatment Sequence 3|Epanova 2 g per day:Lovaza 4 g per day
11199773|NCT02189252|BG003|Baseline|Treatment Sequence 4|Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
11199774|NCT02189252|BG004|Baseline|Total|Total of all reporting groups
11199775|NCT02189252|FG000|Participant Flow|Treatment Sequence 1|Epanova 4g per day: Lovaza 4g per day
11199776|NCT02189252|FG001|Participant Flow|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
11199777|NCT02189252|FG002|Participant Flow|Treatment Sequence 3|Epanova 2g per day:Lovaza 4g per day:
11199778|NCT02189252|FG003|Participant Flow|Treatment Sequence 4|Lovaza 4g per day:Epanova 2g per day:
11199779|NCT02189252|OG000|Outcome|Epanova 2 g|Once daily (QD)
10800282|NCT02089685|BG003|Baseline|Part 1B Pembrolizumab + IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800283|NCT02089685|BG004|Baseline|Part 1C Pembrolizumab + IPI 50 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 50 mg Q6W for up to ~24 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800284|NCT02089685|BG005|Baseline|Part 1C Pembrolizumab + IPI 100 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 100 mg Q12W for up to 48 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800285|NCT02089685|BG006|Baseline|Total|Total of all reporting groups
11199780|NCT02189252|OG001|Outcome|Epanova 4 g|Once daily (QD)
11199781|NCT02189252|OG002|Outcome|Lovaza 4 g|Once daily (QD)
11199782|NCT02189252|EG000|Reported Event|Epanova 2 g (I)|Treatment period I
11199783|NCT02189252|EG001|Reported Event|Epanova 4 g (I)|Treatment period I
11199784|NCT02189252|EG002|Reported Event|Lovaza 4 g (I)|Treatment period I
11199785|NCT02189252|EG003|Reported Event|Epanova 2 g (II)|Treatment period II
11199786|NCT02189252|EG004|Reported Event|Epanova 4 g (II)|Treatment period II
11199787|NCT02189252|EG005|Reported Event|Lovaza 4 g (II)|Treatment period II
11199788|NCT02189317|BG000|Baseline|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199789|NCT02189317|BG001|Baseline|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199790|NCT02189317|BG002|Baseline|Total|Total of all reporting groups
11199791|NCT02189317|FG000|Participant Flow|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199792|NCT02189317|FG001|Participant Flow|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199793|NCT02189317|OG000|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199794|NCT02189317|OG001|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199795|NCT02189317|EG000|Reported Event|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199796|NCT02189317|EG001|Reported Event|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
11199797|NCT02189382|BG000|Baseline|Potassium Oxalate Gel|"Self Applied~Potassium Oxalate"
11199798|NCT02189382|BG001|Baseline|Water|"Self Applied~Water"
11199799|NCT02189382|BG002|Baseline|Total|Total of all reporting groups
11199800|NCT02189382|FG000|Participant Flow|Potassium Oxalate Gel|"Self Applied~Potassium Oxalate"
11199801|NCT02189382|FG001|Participant Flow|Water|"Self Applied~Water"
11199802|NCT02189382|OG000|Outcome|Potassium Oxalate Gel|"Self Applied~Potassium Oxalate"
11199803|NCT02189382|OG001|Outcome|Water|"Self Applied~Water"
11199804|NCT02189382|EG000|Reported Event|Potassium Oxalate Gel|"Self Applied~Potassium Oxalate"
11199805|NCT02189382|EG001|Reported Event|Water|"Self Applied~Water"
11199806|NCT02189473|BG000|Baseline|5 x 4 Gy in 1 Week|"radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199807|NCT02189473|BG001|Baseline|10 x 3 Gy in 2 Weeks|"radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199808|NCT02189473|BG002|Baseline|Total|Total of all reporting groups
11199809|NCT02189473|FG000|Participant Flow|5 x 4 Gy in 1 Week|"radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199810|NCT02189473|FG001|Participant Flow|10 x 3 Gy in 2 Weeks|"radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199811|NCT02189473|OG000|Outcome|5 x 4 Gy in 1 Week|"radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199812|NCT02189473|OG001|Outcome|10 x 3 Gy in 2 Weeks|"radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199813|NCT02189473|EG000|Reported Event|5 x 4 Gy in 1 Week|"radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199814|NCT02189473|EG001|Reported Event|10 x 3 Gy in 2 Weeks|"radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)~radiotherapy: external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)"
11199815|NCT02189629|BG000|Baseline|CD5789 Cream|CD5789 Trifarotene 50 microgram/gram
11199816|NCT02189629|FG000|Participant Flow|CD5789 Cream|CD5789 Trifarotene 50 microgram/gram cream
11199817|NCT02189629|OG000|Outcome|CD5789 Cream|CD5789 Trifarotene 50 microgram/gram
11199818|NCT02189629|EG000|Reported Event|CD5789 Cream|CD5789 Trifarotene 50 microgram/gram
11199819|NCT02189668|BG000|Baseline|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
11199820|NCT02189668|BG001|Baseline|Surgery|Usual care with urgent appendectomy
11199821|NCT02189668|BG002|Baseline|Total|Total of all reporting groups
11199822|NCT02189668|FG000|Participant Flow|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
11199823|NCT02189668|FG001|Participant Flow|Surgery|Usual care with urgent appendectomy
11199824|NCT02189668|OG000|Outcome|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
11199825|NCT02189668|OG001|Outcome|Surgery|Usual care with urgent appendectomy
11199826|NCT02189668|EG000|Reported Event|Non-operative|"Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic~Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic"
11199827|NCT02189668|EG001|Reported Event|Surgery|Usual care with urgent appendectomy
10966108|NCT00885677|EG000|Reported Event|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
10966109|NCT00885677|EG001|Reported Event|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
11199828|NCT02189759|BG000|Baseline|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
10800286|NCT02089685|FG000|Participant Flow|Part 1A Pembrolizumab + IPI 1 mg/kg|Participants in Part 1A received pembrolizumab intravenously (IV) 200 mg every 3 weeks (Q3W) for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199829|NCT02189759|BG001|Baseline|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
11199830|NCT02189759|BG002|Baseline|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
11199831|NCT02189759|BG003|Baseline|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
11199832|NCT02189759|BG004|Baseline|Total|Total of all reporting groups
11199833|NCT02189759|FG000|Participant Flow|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
11339074|NCT03624192|EG000|Reported Event|Experimental: All Participants (Within Patient Control)|"Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.~RECELL + Telfa™ Clear and Xeroform™ dressings~RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings~Telfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings"
11339075|NCT03624504|BG000|Baseline|Micra Implant Group|"Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)~Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements"
11339076|NCT03624504|FG000|Participant Flow|Micra Implant Group|Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
11339077|NCT03624504|OG000|Outcome|Micra Implant Group|Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
11339078|NCT03624504|EG000|Reported Event|Micra Implant Group|Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
11339079|NCT03624920|BG000|Baseline|Sequence ABC|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339080|NCT03624920|BG001|Baseline|Sequence BCA|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339081|NCT03624920|BG002|Baseline|Sequence CAB|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339082|NCT03624920|BG003|Baseline|Sequence ACB|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339083|NCT03624920|BG004|Baseline|Sequence CBA|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339084|NCT03624920|BG005|Baseline|Sequence BAC|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339085|NCT03624920|BG006|Baseline|Total|Total of all reporting groups
11339086|NCT03624920|FG000|Participant Flow|Sequence ABC|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339087|NCT03624920|FG001|Participant Flow|Sequence BCA|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339088|NCT03624920|FG002|Participant Flow|Sequence CAB|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11199834|NCT02189759|FG001|Participant Flow|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
11199835|NCT02189759|FG002|Participant Flow|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
11199836|NCT02189759|FG003|Participant Flow|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
11199837|NCT02189759|OG000|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
11199838|NCT02189759|OG001|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
11199839|NCT02189759|OG000|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
11199840|NCT02189759|OG001|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
10800287|NCT02089685|FG001|Participant Flow|Part 1A Pembrolizumab + Pegylated Interferon Alfa-2b (PEG-IFN) 1 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg subcutaneously (SC) once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
11339089|NCT03624920|FG003|Participant Flow|Sequence ACB|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339090|NCT03624920|FG004|Participant Flow|Sequence CBA|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339091|NCT03624920|FG005|Participant Flow|Sequence BAC|"A : 2 weeks under Placebo~B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)~C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)"
11339092|NCT03624920|OG000|Outcome|Placebo|THN102 Placebo (Dosage A)
11339093|NCT03624920|OG001|Outcome|THN102 200/2|THN102 200 mg/2 mg (Dosage B)
11339094|NCT03624920|OG002|Outcome|THN102 200/18|THN102 200 mg/18 mg (Dosage C)
11339095|NCT03624920|EG000|Reported Event|THN102 Placebo|THN102 Placebo (Dosage A)
11339096|NCT03624920|EG001|Reported Event|THN102 200/2|THN102 200 mg/2 mg (Dosage B)
11339097|NCT03624920|EG002|Reported Event|THN102 200/18|THN102 200 mg/18 mg (Dosage C)
11339098|NCT03624946|BG000|Baseline|Zika Virus Immune Globulin (ZIKV-IG)|"Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes.~Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus."
11339099|NCT03624946|BG001|Baseline|Placebo (Saline Solution)|"Single dose of 50 mL placebo will be administered intravenously over 33 minutes.~Placebo: Placebo is a normal saline solution (0.9% sodium chloride)."
11339100|NCT03624946|BG002|Baseline|Total|Total of all reporting groups
11339101|NCT03624946|FG000|Participant Flow|Zika Virus Immune Globulin (ZIKV-IG)|"Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG).~Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus."
11339102|NCT03624946|FG001|Participant Flow|Placebo (Saline Solution)|"Single dose of 50 mL placebo will be administered intravenously over 33 minutes.~Placebo: Placebo is a normal saline solution (0.9% sodium chloride)."
11339103|NCT03624946|OG000|Outcome|Zika Virus Immune Globulin (ZIKV-IG)|"Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes.~Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus."
11339104|NCT03624946|OG001|Outcome|Placebo (Saline Solution)|"Single dose of 50 mL placebo will be administered intravenously over 33 minutes.~Placebo: Placebo is a normal saline solution (0.9% sodium chloride)."
11339105|NCT03624946|OG000|Outcome|PK Population ZIKV-IG|Subjects who received ZIKV-IG with adequate number of PK samples (a suitable pre-dose sample and at least one measurable post-dose sample), are ZIKV-negative by nucleic acid testing and serology testing and have anti-ZIKV E-protein binding antibodies <12 U/mL.
11339106|NCT03624946|OG001|Outcome|PK Population Excluding Subject 01-127 ZIKV-IG|Subjects who received ZIKV-IG with adequate number of PK samples (a suitable pre-dose sample and at least one measurable post-dose sample), are ZIKV-negative by nucleic acid testing and serology testing and have anti-ZIKV E-protein binding antibodies <12 U/mL excluding subject 01-127.
11339107|NCT03624946|OG000|Outcome|PK Population ZIKV-IG|Subjects who received ZIKV-IG with adequate number of PK samples (a suitable pre-dose sample and at least one measurable post-dose sample)
11339108|NCT03624946|OG001|Outcome|PK Population Excluding Subject 01-127 ZIKV-IG|Subjects who received ZIKV-IG with adequate number of PK samples (a suitable pre-dose sample and at least one measurable post-dose sample) excluding subject 01-127 who likely did not receive the dose intravenously.
11339109|NCT03624946|EG000|Reported Event|Zika Virus Immune Globulin (ZIKV-IG)|"Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes.~Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus."
11339110|NCT03624946|EG001|Reported Event|Placebo (Saline Solution)|"Single dose of 50 mL placebo will be administered intravenously over 33 minutes.~Placebo: Placebo is a normal saline solution (0.9% sodium chloride)."
11339111|NCT03624972|BG000|Baseline|Resources Only|"Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339112|NCT03624972|BG001|Baseline|Resources + Video|"Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called Starting the Conversation and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.~Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339113|NCT03624972|BG002|Baseline|Clinician Arm|Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data was not collected from clinician participants.
11339114|NCT03624972|BG003|Baseline|Total|Total of all reporting groups
11339115|NCT03624972|FG000|Participant Flow|Resources Only|"Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339134|NCT03626415|OG002|Outcome|PF-04965842 (Moderate Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339135|NCT03626415|EG000|Reported Event|PF-04965842 (Normal Hepatic Function Cohort)|Participants with normal hepatic function were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339136|NCT03626415|EG001|Reported Event|PF-04965842 (Mild Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339137|NCT03626415|EG002|Reported Event|PF-04965842 (Moderate Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339138|NCT03626623|BG000|Baseline|Standard of Care (SOC)|"The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.~Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings."
11339139|NCT03626623|BG001|Baseline|Cytal Wound Matrix 1-Layer|"The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).~Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use."
11339140|NCT03626623|BG002|Baseline|Total|Total of all reporting groups
11339141|NCT03626623|FG000|Participant Flow|Standard of Care (SOC)|"The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.~Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings."
11339142|NCT03626623|FG001|Participant Flow|Cytal Wound Matrix 1-Layer|"The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).~Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use."
11339143|NCT03626623|OG000|Outcome|Standard of Care (SOC)|"The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.~Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings."
11339144|NCT03626623|OG001|Outcome|Cytal Wound Matrix 1-Layer|"The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).~Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use."
11339145|NCT03626623|EG000|Reported Event|Standard of Care (SOC)|"The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.~Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings."
11339146|NCT03626623|EG001|Reported Event|Cytal Wound Matrix 1-Layer|"The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).~Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use."
11339147|NCT03626714|BG000|Baseline|Experimental: Sustained Release Injectable Tacrolimus|All subjects will be treated with a single dose injection of sustained-release Tacrolimus.
11339148|NCT03626714|FG000|Participant Flow|Experimental: Sustained Release Injectable Tacrolimus|All subjects will be treated with a single dose injection of sustained-release Tacrolimus.
11339149|NCT03626714|OG000|Outcome|Experimental: Sustained Release Injectable Tacrolimus|All subjects were subcutaneously injected a single dose (0.1 mg/kg) of sustained-release tacrolimus.
11339150|NCT03626714|EG000|Reported Event|Experimental: Sustained Release Injectable Tacrolimus|All subjects were subcutaneously injected a single dose (0.1 mg/kg) of sustained-release tacrolimus.
11339151|NCT03627065|BG000|Baseline|Parsaclisib|parsaclisib was administered orally once a day for up to 12 weeks.
11339152|NCT03627065|FG000|Participant Flow|Parsaclisib|parsaclisib was administered orally once a day.
11339153|NCT03627065|OG000|Outcome|Parsaclisib|parsaclisib was administered orally once a day for up to 12 weeks.
11339154|NCT03627065|EG000|Reported Event|Parsaclisib|parsaclisib was administered orally once a day.
11339155|NCT03627195|BG000|Baseline|Lurasidone 30 mg|Lurasidone injection suspension 30 mg
11339156|NCT03627195|BG001|Baseline|Lurasidone 75 mg|Lurasidone injection suspension 75 mg
11339157|NCT03627195|BG002|Baseline|Lurasidone 150 mg|Lurasidone injection suspension 150 mg
11339158|NCT03627195|BG003|Baseline|Lurasidone 300 mg|Lurasidone injection suspension 300 mg
11339159|NCT03627195|BG004|Baseline|Lurasidone 450 mg|Lurasidone injection suspension 450 mg
11339160|NCT03627195|BG005|Baseline|Placebo|Placebo Injection
11339161|NCT03627195|BG006|Baseline|Total|Total of all reporting groups
11339162|NCT03627195|FG000|Participant Flow|Lurasidone 30 mg|Lurasidone injection suspension 30 mg
11339163|NCT03627195|FG001|Participant Flow|Lurasidone 75 mg|Lurasidone injection suspension 75 mg
11339164|NCT03627195|FG002|Participant Flow|Lurasidone 150 mg|Lurasidone injection suspension 150 mg
11339165|NCT03627195|FG003|Participant Flow|Lurasidone 300 mg|Lurasidone injection suspension 300 mg
11339166|NCT03627195|FG004|Participant Flow|Lurasidone 450 mg|Lurasidone injection suspension 450 mg
11339167|NCT03627195|FG005|Participant Flow|Placebo|Placebo Injection
11339168|NCT03627195|OG000|Outcome|Lurasidone 30 mg|Lurasidone injection suspension 30 mg
11339169|NCT03627195|OG001|Outcome|Lurasidone 75 mg|Lurasidone injection suspension 75 mg
10800288|NCT02089685|FG002|Participant Flow|Part 1A Pembrolizumab + PEG-IFN 2 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 2 µg/kg SC once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
11339170|NCT03627195|OG002|Outcome|Lurasidone 150 mg|Lurasidone injection suspension 150 mg
11339171|NCT03627195|OG003|Outcome|Lurasidone 300 mg|Lurasidone injection suspension 300 mg
11339172|NCT03627195|OG004|Outcome|Lurasidone 450 mg|Lurasidone injection suspension 450 mg
11339173|NCT03627195|OG005|Outcome|Placebo|Placebo Injection
11339174|NCT03627195|EG000|Reported Event|Lurasidone 30 mg|Lurasidone injection suspension 30 mg
11339175|NCT03627195|EG001|Reported Event|Lurasidone 75 mg|Lurasidone injection suspension 75 mg
11339176|NCT03627195|EG002|Reported Event|Lurasidone 150 mg|Lurasidone injection suspension 150 mg
11339177|NCT03627195|EG003|Reported Event|Lurasidone 300 mg|Lurasidone injection suspension 300 mg
11339178|NCT03627195|EG004|Reported Event|Lurasidone 450 mg|Lurasidone injection suspension 450 mg
11339179|NCT03627195|EG005|Reported Event|Placebo|Placebo Injection
11339180|NCT03627299|BG000|Baseline|Deceased Donor HCV RNA PCR+|"Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks~300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant"
11339181|NCT03627299|FG000|Participant Flow|Deceased Donor HCV RNA PCR+|"Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks~300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant"
11339182|NCT03627299|OG000|Outcome|Deceased Donor HCV RNA PCR+|"Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks~300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant"
11339183|NCT03627299|EG000|Reported Event|Deceased Donor HCV RNA PCR+|"Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks~300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant"
11339184|NCT03627416|BG000|Baseline|Active rTMS, Then Sham rTMS|"First intervention:~10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~The washout period will last at least one month.~Second intervention:~Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339185|NCT03627416|BG001|Baseline|Sham rTMS, Then Active rTMS|"First intervention:~Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~The washout period will last at least one month.~Second intervention:~10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339186|NCT03627416|BG002|Baseline|Total|Total of all reporting groups
11339187|NCT03627416|FG000|Participant Flow|Active rTMS First, Then Sham rTMS|"First intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~The washout will last at least one month.~Second intervention:~Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339188|NCT03627416|FG001|Participant Flow|Sham rTMS, Then Active rTMS|"First intervention: Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~The washout will last at least one month.~Second intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339189|NCT03627416|OG000|Outcome|Active rTMS|"10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339190|NCT03627416|OG001|Outcome|Sham rTMS|"Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339191|NCT03627416|EG000|Reported Event|Active rTMS|"10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11199841|NCT02189759|OG002|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
11199842|NCT02189759|OG003|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
11199843|NCT02189759|EG000|Reported Event|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
11199844|NCT02189759|EG001|Reported Event|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
11199845|NCT02189759|EG002|Reported Event|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
11199846|NCT02189759|EG003|Reported Event|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
11199847|NCT02189837|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199848|NCT02189837|BG001|Baseline|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199849|NCT02189837|BG002|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199850|NCT02189837|BG003|Baseline|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199851|NCT02189837|BG004|Baseline|Total|Total of all reporting groups
11199852|NCT02189837|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199853|NCT02189837|FG001|Participant Flow|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199854|NCT02189837|FG002|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199855|NCT02189837|FG003|Participant Flow|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199856|NCT02189837|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199857|NCT02189837|OG001|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199858|NCT02189837|OG002|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199859|NCT02189837|OG003|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199860|NCT02189837|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199861|NCT02189837|EG001|Reported Event|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199862|NCT02189837|EG002|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
11199863|NCT02189837|EG003|Reported Event|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
11199864|NCT02189850|BG000|Baseline|BLI800 - Dose 1|"BLI800 oral solution~BLI800 - Dose 1: BLI800 oral solution (6 oz)"
11199865|NCT02189850|BG001|Baseline|BLI800 - Dose 2|"BLI800 oral solution~BLI800 - Dose 2: BLI800 oral solution (4.5 oz)"
11199866|NCT02189850|BG002|Baseline|Total|Total of all reporting groups
11199867|NCT02189850|FG000|Participant Flow|BLI800 - Dose 1|"BLI800 oral solution~BLI800 - Dose 1: BLI800 oral solution (6 oz)"
11199868|NCT02189850|FG001|Participant Flow|BLI800 - Dose 2|"BLI800 oral solution~BLI800 - Dose 2: BLI800 oral solution (4.5 oz)"
11199869|NCT02189850|OG000|Outcome|BLI800 - Dose 1|"BLI800 oral solution~BLI800 - Dose 1: BLI800 oral solution (6 oz)"
11199870|NCT02189850|OG001|Outcome|BLI800 - Dose 2|"BLI800 oral solution~BLI800 - Dose 2: BLI800 oral solution (4.5 oz)"
11199871|NCT02189850|EG000|Reported Event|BLI800 - Dose 1|"BLI800 oral solution~BLI800 - Dose 1: BLI800 oral solution (6 oz)"
11199872|NCT02189850|EG001|Reported Event|BLI800 - Dose 2|"BLI800 oral solution~BLI800 - Dose 2: BLI800 oral solution (4.5 oz)"
11199873|NCT02189863|BG000|Baseline|Overall|Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
11199874|NCT02189863|FG000|Participant Flow|AOAMV, Then AOAMF|Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2
11199875|NCT02189863|FG001|Participant Flow|AOAMF, Then AOAMV|Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
11339192|NCT03627416|EG001|Reported Event|Sham rTMS|"Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.~rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities"
11339193|NCT03627494|BG000|Baseline|GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg|Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339194|NCT03627494|BG001|Baseline|Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339195|NCT03627494|BG002|Baseline|GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo|Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339196|NCT03627494|BG003|Baseline|GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo|Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339197|NCT03627494|BG004|Baseline|Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339198|NCT03627494|BG005|Baseline|GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg|Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339199|NCT03627494|BG006|Baseline|Placebo|Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339200|NCT03627494|BG007|Baseline|GSK3439171A 5 mg|Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339201|NCT03627494|BG008|Baseline|GSK3439171A 11 mg|Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339202|NCT03627494|BG009|Baseline|GSK3439171A 40 mg|Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339203|NCT03627494|BG010|Baseline|GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed|Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339204|NCT03627494|BG011|Baseline|GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted|Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339205|NCT03627494|BG012|Baseline|Total|Total of all reporting groups
11339206|NCT03627494|FG000|Participant Flow|GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg|Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339207|NCT03627494|FG001|Participant Flow|Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339208|NCT03627494|FG002|Participant Flow|GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo|Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11199876|NCT02189863|OG000|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
11199877|NCT02189863|OG001|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
10800289|NCT02089685|FG003|Participant Flow|Part 1B Pembrolizumab + IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199878|NCT02189863|EG000|Reported Event|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
11199879|NCT02189863|EG001|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
11199880|NCT02189863|EG002|Reported Event|Lotra B SVD|Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment
11199881|NCT02189863|EG003|Reported Event|Biofinity MF|Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment
11199882|NCT02189863|EG004|Reported Event|Habitual|Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
11199883|NCT02189889|BG000|Baseline|EPO and Feraheme|"Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.~EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.~Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO."
11199884|NCT02189889|BG001|Baseline|Control|The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
11199885|NCT02189889|BG002|Baseline|Total|Total of all reporting groups
11199886|NCT02189889|FG000|Participant Flow|EPO and Feraheme|"Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.~EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.~Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO."
11199887|NCT02189889|FG001|Participant Flow|Control|The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
11199888|NCT02189889|OG000|Outcome|EPO and Feraheme|"Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.~EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.~Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO."
11199889|NCT02189889|OG001|Outcome|Control|The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
11199890|NCT02189889|EG000|Reported Event|EPO and Feraheme|"Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.~EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.~Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO."
11199891|NCT02189889|EG001|Reported Event|Control|The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
11199892|NCT02189915|BG000|Baseline|Creatine Monohydrate|Creatine monohydrate
11199893|NCT02189915|FG000|Participant Flow|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
11199894|NCT02189915|OG000|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
11199895|NCT02189915|EG000|Reported Event|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
11199896|NCT02189941|BG000|Baseline|Healthy Volunteers|Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart
11199897|NCT02189941|FG000|Participant Flow|DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release (IR) tablets under fasting conditions"
11199898|NCT02189941|FG001|Participant Flow|DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions"
11199899|NCT02189941|FG002|Participant Flow|Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions"
11199900|NCT02189941|OG000|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
11199901|NCT02189941|OG001|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
11199902|NCT02189941|OG002|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
11199903|NCT02189941|EG000|Reported Event|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
11199904|NCT02189941|EG001|Reported Event|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
11199905|NCT02189941|EG002|Reported Event|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
11199906|NCT02189954|BG000|Baseline|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
11199907|NCT02189954|BG001|Baseline|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
11199908|NCT02189954|BG002|Baseline|Total|Total of all reporting groups
11199909|NCT02189954|FG000|Participant Flow|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
10800290|NCT02089685|FG004|Participant Flow|Part 1C Pembrolizumab + IPI 50 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 50 mg every 6 weeks (Q6W) for up to ~24 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199910|NCT02189954|FG001|Participant Flow|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)"
11199911|NCT02189954|OG000|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
11199912|NCT02189954|OG001|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
10800291|NCT02089685|FG005|Participant Flow|Part 1C Pembrolizumab + IPI 100 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 100 mg every 12 weeks (Q12W) for up to 48 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800292|NCT02089685|OG000|Outcome|Part 1A Pembrolizumab + IPI 1 mg/kg (MEL)|Participants in Part 1A with MEL received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800293|NCT02089685|OG001|Outcome|Part 1A Pembrolizumab + IPI 1 mg/kg (RCC)|Participants in Part 1A with RCC received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800294|NCT02089685|OG002|Outcome|Part 1A Pembrolizumab + PEG-IFN 1 µg/kg (MEL)|Participants in Part 1A with MEL received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg SC once a week for up to ~2 years.
10800295|NCT02089685|OG003|Outcome|Part 1A Pembrolizumab + PEG-IFN 1 µg/kg (RCC)|Participants in Part 1A with RCC received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg SC once a week for up to ~2 years.
10800296|NCT02089685|OG004|Outcome|Part 1A Pembrolizumab + PEG-IFN 2 µg/kg (RCC)|Participants in Part 1A with RCC received pembrolizumab IV 200 mg Q3W + PEG-IFN 2 µg/kg SC once a week for up to ~2 years.
10800297|NCT02089685|OG005|Outcome|Part 1B Pembrolizumab+ IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800298|NCT02089685|OG006|Outcome|Part 1C Pembrolizumab + IPI 50 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 50 mg Q6W for up to ~24 weeks.
10800299|NCT02089685|OG007|Outcome|Part 1C Pembrolizumab + IPI 100 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 100 mg Q12W for up to ~48 weeks.
10800300|NCT02089685|OG000|Outcome|Part 1A Pembrolizumab + IPI 1 mg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800301|NCT02089685|OG001|Outcome|Part 1A Pembrolizumab + PEG-IFN 1 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg SC once a week for up to ~2 years.
10800302|NCT02089685|OG002|Outcome|Part 1A Pembrolizumab + PEG-IFN 2 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 2 µg/kg SC once a week for up to ~2 years.
10800303|NCT02089685|OG003|Outcome|Part 1B Pembrolizumab+ IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800304|NCT02089685|OG004|Outcome|Part 1C Pembrolizumab + IPI 50 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 50 mg Q6W for up to ~24 weeks.
10800305|NCT02089685|OG005|Outcome|Part 1C Pembrolizumab + IPI 100 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 100 mg Q12W for up to ~48 weeks.
10800306|NCT02089685|OG000|Outcome|Part 1A Pembrolizumab + IPI 1mg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800307|NCT02089685|OG003|Outcome|Part 1B Pembrolizumab + IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks.
10800308|NCT02089685|EG000|Reported Event|Part 1A Pembrolizumab + IPI 1 mg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800309|NCT02089685|EG001|Reported Event|Part 1A Pembrolizumab + PEG-IFN 1 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 1 µg/kg SC once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
11199913|NCT02189954|EG000|Reported Event|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
11199914|NCT02189954|EG001|Reported Event|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
11199915|NCT02190045|BG000|Baseline|Wii-Fit Program|"Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199916|NCT02190045|BG001|Baseline|Cognitive Remediation Program|"Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199917|NCT02190045|BG002|Baseline|Total|Total of all reporting groups
11199918|NCT02190045|FG000|Participant Flow|Wii-Fit Program|"Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199919|NCT02190045|FG001|Participant Flow|Cognitive Remediation Program|"Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199920|NCT02190045|OG000|Outcome|Wii-Fit Program|"Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199921|NCT02190045|OG001|Outcome|Cognitive Remediation Program|"Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199922|NCT02190045|EG000|Reported Event|Wii-Fit Program|"Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199923|NCT02190045|EG001|Reported Event|Cognitive Remediation Program|"Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks~Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks"
11199924|NCT02190279|BG000|Baseline|Suspected Localized Prostate Cancer|"Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.~N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199925|NCT02190279|BG001|Baseline|Biochemical Recurrence|"Patients with biochemical prostate cancer relapse after definitive treatment~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199926|NCT02190279|BG002|Baseline|Known Metastatic Disease|"Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199927|NCT02190279|BG003|Baseline|Total|Total of all reporting groups
11199928|NCT02190279|FG000|Participant Flow|Suspected Localized Prostate Cancer|"Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.~N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199929|NCT02190279|FG001|Participant Flow|Biochemical Recurrence|"Patients with biochemical prostate cancer relapse after definitive treatment~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199930|NCT02190279|FG002|Participant Flow|Known Metastatic Disease|"Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199931|NCT02190279|OG000|Outcome|Suspected Localized Prostate Cancer|"Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.~N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199932|NCT02190279|OG001|Outcome|Biochemical Recurrence|"Patients with biochemical prostate cancer relapse after definitive treatment~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199933|NCT02190279|OG002|Outcome|Known Metastatic Disease|"Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11242361|NCT02495038|BG001|Baseline|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
10966110|NCT00885703|BG000|Baseline|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966111|NCT00885703|BG001|Baseline|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
11199934|NCT02190279|OG000|Outcome|Known Metastatic Disease|"Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199935|NCT02190279|OG000|Outcome|Biochemical Recurrence|"Patients with biochemical prostate cancer relapse after definitive treatment~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199936|NCT02190279|EG000|Reported Event|Suspected Localized Prostate Cancer|"Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.~N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199937|NCT02190279|EG001|Reported Event|Biochemical Recurrence|"Patients with biochemical prostate cancer relapse after definitive treatment~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
11199938|NCT02190279|EG002|Reported Event|Known Metastatic Disease|"Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.~18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."
10800310|NCT02089685|EG002|Reported Event|Part 1A Pembrolizumab + PEG-IFN 2 µg/kg|Participants in Part 1A received pembrolizumab IV 200 mg Q3W + PEG-IFN 2 µg/kg SC once a week for up to ~2 years. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year.
10800311|NCT02089685|EG003|Reported Event|Part 1B Pembrolizumab + IPI 1 mg/kg|Participants in Part 1B received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 1 mg/kg Q3W for up to ~12 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199939|NCT02190435|BG000|Baseline|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
11199940|NCT02190435|BG001|Baseline|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
11199941|NCT02190435|BG002|Baseline|Total|Total of all reporting groups
11199942|NCT02190435|FG000|Participant Flow|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
11199943|NCT02190435|FG001|Participant Flow|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
11199944|NCT02190435|OG000|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
11199945|NCT02190435|OG001|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
11199946|NCT02190435|EG000|Reported Event|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
10800312|NCT02089685|EG004|Reported Event|Part 1C Pembrolizumab + IPI 50 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 50 mg Q6W for up to ~24 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
11199947|NCT02190435|EG001|Reported Event|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
11199948|NCT02190552|BG000|Baseline|EmboTrap® Revascularization Device|"The EmboTrap® Revascularization Device is the investigational device~EmboTrap® Revascularization Device"
11199949|NCT02190552|FG000|Participant Flow|EmboTrap® Revascularization Device|"The EmboTrap® Revascularization Device is the investigational device~EmboTrap® Revascularization Device"
11199950|NCT02190552|OG000|Outcome|EmboTrap® Revascularization Device|The EmboTrap® Revascularization Device is the investigational device
11199951|NCT02190552|OG000|Outcome|EmboTrap® Revascularization Device|"The EmboTrap® Revascularization Device is the investigational device~EmboTrap® Revascularization Device"
10966112|NCT00885703|BG002|Baseline|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966113|NCT00885703|BG003|Baseline|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966114|NCT00885703|BG004|Baseline|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966115|NCT00885703|BG005|Baseline|Stage 2, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
11199952|NCT02190552|EG000|Reported Event|EmboTrap® Revascularization Device|"The EmboTrap® Revascularization Device is the investigational device~EmboTrap® Revascularization Device"
11199953|NCT02190591|BG000|Baseline|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
11199954|NCT02190591|BG001|Baseline|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
11199955|NCT02190591|BG002|Baseline|Total|Total of all reporting groups
11199956|NCT02190591|FG000|Participant Flow|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
11242362|NCT02495038|BG002|Baseline|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
11242363|NCT02495038|BG003|Baseline|Total|Total of all reporting groups
11199957|NCT02190591|FG001|Participant Flow|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
11199958|NCT02190591|OG000|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
10966116|NCT00885703|BG006|Baseline|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966117|NCT00885703|BG007|Baseline|Total|Total of all reporting groups
10966118|NCT00885703|FG000|Participant Flow|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
11199959|NCT02190591|OG001|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
11199960|NCT02190591|EG000|Reported Event|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
11199961|NCT02190591|EG001|Reported Event|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
11199962|NCT02190604|BG000|Baseline|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11242364|NCT02495038|FG000|Participant Flow|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
11199963|NCT02190604|BG001|Baseline|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199964|NCT02190604|BG002|Baseline|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
10800313|NCT02089685|EG005|Reported Event|Part 1C Pembrolizumab + IPI 100 mg|Participants in Part 1C received pembrolizumab IV 200 mg Q3W for up to ~2 years + IPI IV 100 mg Q12W for up to 48 weeks. Qualified participants who received the first course but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year + IPI at the same dose and schedule for up ~12 additional weeks.
10800314|NCT02075320|BG000|Baseline|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
11199965|NCT02190604|BG003|Baseline|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199966|NCT02190604|BG004|Baseline|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
10804008|NCT00569127|BG000|Baseline|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10804009|NCT00569127|BG001|Baseline|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11199967|NCT02190604|BG005|Baseline|Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199968|NCT02190604|BG006|Baseline|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
10804010|NCT00569127|BG002|Baseline|Total|Total of all reporting groups
11199969|NCT02190604|BG007|Baseline|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199970|NCT02190604|BG008|Baseline|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199971|NCT02190604|BG009|Baseline|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199972|NCT02190604|BG010|Baseline|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
10804011|NCT00569127|FG000|Participant Flow|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11199973|NCT02190604|BG011|Baseline|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199974|NCT02190604|BG012|Baseline|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199975|NCT02190604|BG013|Baseline|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199976|NCT02190604|BG014|Baseline|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199977|NCT02190604|BG015|Baseline|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199978|NCT02190604|BG016|Baseline|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199979|NCT02190604|BG017|Baseline|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199980|NCT02190604|BG018|Baseline|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199981|NCT02190604|BG019|Baseline|Total|Total of all reporting groups
11199982|NCT02190604|FG000|Participant Flow|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199983|NCT02190604|FG001|Participant Flow|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199984|NCT02190604|FG002|Participant Flow|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199985|NCT02190604|FG003|Participant Flow|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199986|NCT02190604|FG004|Participant Flow|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199987|NCT02190604|FG005|Participant Flow|Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199988|NCT02190604|FG006|Participant Flow|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199989|NCT02190604|FG007|Participant Flow|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199990|NCT02190604|FG008|Participant Flow|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11199991|NCT02190604|FG009|Participant Flow|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199992|NCT02190604|FG010|Participant Flow|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199993|NCT02190604|FG011|Participant Flow|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199994|NCT02190604|FG012|Participant Flow|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199995|NCT02190604|FG013|Participant Flow|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199996|NCT02190604|FG014|Participant Flow|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11199997|NCT02190604|FG015|Participant Flow|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199998|NCT02190604|FG016|Participant Flow|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11199999|NCT02190604|FG017|Participant Flow|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11200000|NCT02190604|FG018|Participant Flow|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11200001|NCT02190604|OG000|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200002|NCT02190604|OG001|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200003|NCT02190604|OG002|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200004|NCT02190604|OG003|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200005|NCT02190604|OG004|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200006|NCT02190604|OG005|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200007|NCT02190604|OG006|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200008|NCT02190604|OG007|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200009|NCT02190604|OG008|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200010|NCT02190604|OG009|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200011|NCT02190604|OG010|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200012|NCT02190604|OG011|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200013|NCT02190604|OG012|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200014|NCT02190604|OG013|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15
11200015|NCT02190604|OG014|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200016|NCT02190604|OG015|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200017|NCT02190604|OG000|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11200018|NCT02190604|OG001|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11200019|NCT02190604|OG002|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
11200020|NCT02190604|OG003|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
10966119|NCT00885703|FG001|Participant Flow|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966120|NCT00885703|FG002|Participant Flow|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966719|NCT00888615|FG000|Participant Flow|Treatment (Paclitaxel, Elesclomol Sodium)|"Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.~Elesclomol Sodium: Given IV~Paclitaxel: Given IV"
11200021|NCT02190604|OG000|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200022|NCT02190604|OG001|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200023|NCT02190604|OG002|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200024|NCT02190604|OG003|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200025|NCT02190604|OG004|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200026|NCT02190604|OG005|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200027|NCT02190604|OG006|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200028|NCT02190604|OG007|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200029|NCT02190604|OG008|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200030|NCT02190604|OG009|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
11200031|NCT02190604|OG000|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200032|NCT02190604|OG001|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200033|NCT02190604|OG002|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200034|NCT02190604|OG003|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200035|NCT02190604|OG004|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200036|NCT02190604|OG005|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
11200037|NCT02190604|EG000|Reported Event|Part 1 Placebo|Part 1 Placebo
11200038|NCT02190604|EG001|Reported Event|Part 1 QBW251 10mg|Part 1 QBW251 10mg
11200039|NCT02190604|EG002|Reported Event|Part 1 QBW251 25mg|Part 1 QBW251 25mg
11200040|NCT02190604|EG003|Reported Event|Part 1 QBW251 150mg|Part 1 QBW251 150mg
11200041|NCT02190604|EG004|Reported Event|Part 1 QBW251 300mg|Part 1 QBW251 300mg
11200042|NCT02190604|EG005|Reported Event|Part 1 QBW251 500mg|Part 1 QBW251 500mg
11200043|NCT02190604|EG006|Reported Event|Part 1 QBW251 500mg (Fed)|Part 1 QBW251 500mg (fed)
11200044|NCT02190604|EG007|Reported Event|Part 1 QBW251 750mg|Part 1 QBW251 750mg
11200045|NCT02190604|EG008|Reported Event|Part 1 QBW251 1000mg|Part 1 QBW251 1000mg
11200046|NCT02190604|EG009|Reported Event|Part 2 Placebo|Part 2 Placebo
11200047|NCT02190604|EG010|Reported Event|Part 2 QBW251 150mg|Part 2 QBW251 150mg
11200048|NCT02190604|EG011|Reported Event|Part 2 QBW251 400mg|Part 2 QBW251 400mg
11200049|NCT02190604|EG012|Reported Event|Part 2 QBW251 750mg|Part 2 QBW251 750mg
11200050|NCT02190604|EG013|Reported Event|Part 2 QBW251 450mg BID|Part 2 QBW251 450mg BID
11200051|NCT02190604|EG014|Reported Event|Part 2 QBW251 750mg BID|Part 2 QBW251 750mg BID
11200052|NCT02190604|EG015|Reported Event|Part 3 Placebo C1/C2/C3|Part 3 Placebo C1/C2/C3
11200053|NCT02190604|EG016|Reported Event|Part 3 QBW251 150mg BID C1|Part 3 QBW251 150mg BID C1
11200054|NCT02190604|EG017|Reported Event|Part 3 QBW251 450mg BID C2|Part 3 QBW251 450mg BID C2
11200055|NCT02190604|EG018|Reported Event|Part 3 QBW251 450mg BID C3|Part 3 QBW251 450mg BID C3
11200056|NCT02190747|BG000|Baseline|Palovarotene 10/5 mg|Subjects received palovarotene 10 mg orally for 14 days followed by 5 mg orally for 28 days during flare-ups (10/5 mg regimen). The subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200057|NCT02190747|BG001|Baseline|Palovarotene 5/2.5 mg|Subjects received palovarotene 5 mg orally for 14 days followed by 2.5 mg orally for 28 days during flare-ups (5/2.5 mg regimen). The subjects were followed for an additional 42 days without treatment. Only subjects in Cohort 2 contributed to this arm.
11200058|NCT02190747|BG002|Baseline|Placebo|Subjects received placebo (matching with palovarotene) for 42 days during flare-ups. Subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200059|NCT02190747|BG003|Baseline|Total|Total of all reporting groups
11200060|NCT02190747|FG000|Participant Flow|Palovarotene 10/5 mg|Subjects received palovarotene 10 milligram (mg) orally for 14 days followed by 5 mg orally for 28 days during flare-ups (10/5 mg regimen). The subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200061|NCT02190747|FG001|Participant Flow|Palovarotene 5/2.5 mg|Subjects received palovarotene 5 mg orally for 14 days followed by 2.5 mg orally for 28 days during flare-ups (5/2.5 mg regimen). The subjects were followed for an additional 42 days without treatment. Only subjects in Cohort 2 contributed to this arm.
11200062|NCT02190747|FG002|Participant Flow|Placebo|Subjects received placebo (matching with palovarotene) for 42 days during flare-ups. Subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200063|NCT02190747|OG000|Outcome|Palovarotene 10/5 mg|Subjects received palovarotene 10 mg orally for 14 days followed by 5 mg orally for 28 days during flare-ups (10/5 mg regimen). The subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200064|NCT02190747|OG001|Outcome|Palovarotene 5/2.5 mg|Subjects received palovarotene 5 mg orally for 14 days followed by 2.5 mg orally for 28 days during flare-ups (5/2.5 mg regimen). The subjects were followed for an additional 42 days without treatment. Only subjects in Cohort 2 contributed to this arm.
11200065|NCT02190747|OG002|Outcome|Placebo|Subjects received placebo (matching with palovarotene) for 42 days during flare-ups. Subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200066|NCT02190747|EG000|Reported Event|Palovarotene 10/5 mg|Subjects received palovarotene 10 mg orally for 14 days followed by 5 mg orally for 28 days during flare-ups (10/5 mg regimen). The subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200067|NCT02190747|EG001|Reported Event|Palovarotene 5/2.5 mg|Subjects received palovarotene 5 mg orally for 14 days followed by 2.5 mg orally for 28 days during flare-ups (5/2.5 mg regimen). The subjects were followed for an additional 42 days without treatment. Only subjects in Cohort 2 contributed to this arm.
11200068|NCT02190747|EG002|Reported Event|Placebo|Subjects received placebo (matching with palovarotene) for 42 days during flare-ups. Subjects were followed for an additional 42 days without treatment. Subjects in Cohort 1 and Cohort 2 contributed to this arm.
11200069|NCT02190903|BG000|Baseline|General Endotracheal Anesthesia|"Standard care general endotracheal anesthesia~General endotracheal anesthesia: General Anesthesia~Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol."
11200070|NCT02190903|BG001|Baseline|Regional (Spinal) Anesthesia|"Standard care spinal anesthesia~Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen."
11200071|NCT02190903|BG002|Baseline|Total|Total of all reporting groups
11200072|NCT02190903|FG000|Participant Flow|General Endotracheal Anesthesia|"Standard care general endotracheal anesthesia~General endotracheal anesthesia: General Anesthesia~Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol."
11200073|NCT02190903|FG001|Participant Flow|Regional (Spinal) Anesthesia|"Standard care spinal anesthesia~Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen."
11200074|NCT02190903|OG000|Outcome|General Endotracheal Anesthesia|"Standard care general endotracheal anesthesia~General endotracheal anesthesia: General Anesthesia~Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol."
11242365|NCT02495038|FG001|Participant Flow|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
11242366|NCT02495038|FG002|Participant Flow|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
11242367|NCT02495038|OG000|Outcome|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response."
11242368|NCT02495038|OG001|Outcome|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe."
11242369|NCT02495038|OG002|Outcome|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95."
11242370|NCT02495038|EG000|Reported Event|Intubating Dose, Group I|"combined ED95 rocuronium and ED95 cisatracurium~ED95, dose causing on average 95% suppression of neuromuscular response.~The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation."
11242371|NCT02495038|EG001|Reported Event|10% Reduction of Combination of Esmeron® and Nimbex®, Group S|"This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium~10% reduction of combination of Esmeron® and Nimbex®: Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.~The duration of intubation did not differ between groups. Group I and S were intubation Grade 0 (Excellent) intubation"
11242372|NCT02495038|EG002|Reported Event|20% Reduction of Combination of Esmeron® and Nimbex®, Group L|"This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium~20% reduction of combination of Esmeron® and Nimbex®: The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.~Group L included 1 patient with Grade 1 (Good) intubation and 2 patients with Grade 2 (Poor) intubation. The patients with Grade 2 intubation coughed during intubation and 1 of these patients produced small arm movements during coughing."
11242373|NCT02495103|BG000|Baseline|Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib"
11242374|NCT02495103|BG001|Baseline|Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib"
11242375|NCT02495103|BG002|Baseline|Total|Total of all reporting groups
11242376|NCT02495103|FG000|Participant Flow|Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib"
11242377|NCT02495103|FG001|Participant Flow|Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib"
11242378|NCT02495103|OG000|Outcome|All Participants|All participants that received Phase I, Dose Level 1 - Metformin 250mg daily/Vandetanib 300mg daily; and Phase I, Dose Level 2 - Metformin 250mg twice daily/Vandetanib 300mg daily.
11242379|NCT02495103|OG000|Outcome|Phase II Component- Vandetanib/Metformin|Phase II Component- Vandetanib/Metformin
11242380|NCT02495103|OG000|Outcome|Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib"
11242381|NCT02495103|OG001|Outcome|Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib"
11242382|NCT02495103|EG000|Reported Event|Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib"
10966121|NCT00885703|FG003|Participant Flow|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
11242383|NCT02495103|EG001|Reported Event|Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily|"Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib"
11242384|NCT02495168|BG000|Baseline|Generic Budesonide/Formoterol Fumarate Dihydrate|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242385|NCT02495168|BG001|Baseline|Symbicort (Budesonide/Formoterol Fumarate Dihydrate)|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242386|NCT02495168|BG002|Baseline|Placebo|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
11242387|NCT02495168|BG003|Baseline|Total|Total of all reporting groups
11242388|NCT02495168|FG000|Participant Flow|Generic Budesonide/Formoterol Fumarate Dihydrate|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 microgram [μg]/4.5 μg) pMDI for up to 50 days.
11242389|NCT02495168|FG001|Participant Flow|Symbicort (Budesonide/Formoterol Fumarate Dihydrate)|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242390|NCT02495168|FG002|Participant Flow|Placebo|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
11242391|NCT02495168|OG000|Outcome|Generic Budesonide/Formoterol Fumarate Dihydrate|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242392|NCT02495168|OG001|Outcome|Symbicort (Budesonide/Formoterol Fumarate Dihydrate)|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242393|NCT02495168|OG002|Outcome|Placebo|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
11242394|NCT02495168|EG000|Reported Event|Generic Budesonide/Formoterol Fumarate Dihydrate|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
10804012|NCT00569127|FG001|Participant Flow|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11242395|NCT02495168|EG001|Reported Event|Symbicort (Budesonide/Formoterol Fumarate Dihydrate)|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
11242396|NCT02495168|EG002|Reported Event|Placebo|After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
11242397|NCT02495233|BG000|Baseline|Gilteritinib 120mg + Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242398|NCT02495233|BG001|Baseline|Gilteritinib 80mg+ Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242399|NCT02495233|BG002|Baseline|Total|Total of all reporting groups
11242400|NCT02495233|FG000|Participant Flow|Gilteritinib 120mg + Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242401|NCT02495233|FG001|Participant Flow|Gilteritinib 80mg+ Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242402|NCT02495233|OG000|Outcome|Gilteritinib 120mg + Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242403|NCT02495233|OG001|Outcome|Gilteritinib 80mg+ Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242404|NCT02495233|EG000|Reported Event|Gilteritinib 120mg + Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242405|NCT02495233|EG001|Reported Event|Gilteritinib 80mg+ Erlotinib 150mg|Gilteritinib was administered in combination with erlotinib orally once daily.
11242406|NCT02495259|BG000|Baseline|ZU-bend Stylet With GlideScope Technique|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
10804013|NCT00569127|OG000|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11242407|NCT02495259|BG001|Baseline|GlideScope With the GlideRite Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
10804014|NCT00569127|OG001|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
10966122|NCT00885703|FG004|Participant Flow|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966123|NCT00885703|FG005|Participant Flow|Stage 2, Fulconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10804015|NCT00569127|EG000|Reported Event|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11242408|NCT02495259|BG002|Baseline|Macintosh Blade and a Regular DLT Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
10966720|NCT00888615|OG000|Outcome|Treatment (Paclitaxel, Elesclomol Sodium)|"Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.~Elesclomol Sodium: Given IV~Paclitaxel: Given IV"
11242409|NCT02495259|BG003|Baseline|Total|Total of all reporting groups
11242410|NCT02495259|FG000|Participant Flow|ZU-bend Stylet With GlideScope Technique|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
10804016|NCT00569127|EG001|Reported Event|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
11339209|NCT03627494|FG003|Participant Flow|GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo|Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339210|NCT03627494|FG004|Participant Flow|Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339211|NCT03627494|FG005|Participant Flow|GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg|Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339212|NCT03627494|FG006|Participant Flow|Placebo|Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339213|NCT03627494|FG007|Participant Flow|GSK3439171A 5 mg|Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339214|NCT03627494|FG008|Participant Flow|GSK3439171A 11 mg|Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339215|NCT03627494|FG009|Participant Flow|GSK3439171A 40 mg|Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339216|NCT03627494|FG010|Participant Flow|GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed|Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339217|NCT03627494|FG011|Participant Flow|GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted|Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339218|NCT03627494|OG000|Outcome|Part A: Placebo|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
11339219|NCT03627494|OG001|Outcome|Part A: GSK3439171A 5 mg|Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
11339220|NCT03627494|OG002|Outcome|Part A: GSK3439171A 10 mg|Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
11339221|NCT03627494|OG003|Outcome|Part A: GSK3439171A 30 mg|Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
11339222|NCT03627494|OG004|Outcome|Part A: GSK3439171A 60 mg|Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
11339223|NCT03627494|OG005|Outcome|Part A: GSK3439171A 120 mg|Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
11339224|NCT03627494|OG006|Outcome|Part A: GSK3439171A 180 mg|Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
11339225|NCT03627494|OG000|Outcome|Part B: Placebo|Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339226|NCT03627494|OG001|Outcome|Part B: GSK3439171A 5 mg|Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339227|NCT03627494|OG002|Outcome|Part B: GSK3439171A 11 mg|Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339228|NCT03627494|OG003|Outcome|Part B: GSK3439171A 40 mg|Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339229|NCT03627494|OG000|Outcome|Part C: GSK3439171A 60 mg Fasted|Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2.
11339230|NCT03627494|OG001|Outcome|Part C: GSK3439171A 60 mg Fed|Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2.
11339231|NCT03627494|OG000|Outcome|Part A: GSK3439171A 5 mg|Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
11339232|NCT03627494|OG000|Outcome|Part A: GSK3439171A 10 mg|Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
11339233|NCT03627494|OG001|Outcome|Part A: GSK3439171A 30 mg|Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
11339234|NCT03627494|OG002|Outcome|Part A: GSK3439171A 60 mg|Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
11339235|NCT03627494|OG003|Outcome|Part A: GSK3439171A 120 mg|Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
11339236|NCT03627494|OG004|Outcome|Part A: GSK3439171A 180 mg|Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
11339237|NCT03627494|OG000|Outcome|Part B: GSK3439171A 5 mg|Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339238|NCT03627494|OG001|Outcome|Part B: GSK3439171A 11 mg|Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339239|NCT03627494|OG000|Outcome|Part B: GSK3439171A 40 mg|Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339240|NCT03627494|OG000|Outcome|GSK3439171A 5 mg to 180 mg|Participants were administered single oral doses of GSK3439171A 5 mg, 10 mg, 30 mg, 60 mg, 120 mg and 180 mg in either treatment period 1, 2 or 3.
11339241|NCT03627494|OG000|Outcome|GSK3439171A 5 mg to 40 mg|Participants were administered once daily oral doses of GSK3439171A 5 mg, 11 mg and 40 mg for up to 14 days.
11339242|NCT03627494|EG000|Reported Event|Part A: Placebo|Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
11339243|NCT03627494|EG001|Reported Event|Part A: GSK3439171A 5 mg|Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
11339244|NCT03627494|EG002|Reported Event|Part A: GSK3439171A 10 mg|Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
11339245|NCT03627494|EG003|Reported Event|Part A: GSK3439171A 30 mg|Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
11339246|NCT03627494|EG004|Reported Event|Part A: GSK3439171A 60 mg|Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
11339247|NCT03627494|EG005|Reported Event|Part A: GSK3439171A 120 mg|Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
11339248|NCT03627494|EG006|Reported Event|Part A: GSK3439171A 180 mg|Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
11339249|NCT03627494|EG007|Reported Event|Part B: Placebo|Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339250|NCT03627494|EG008|Reported Event|Part B: GSK3439171A 5 mg|Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339251|NCT03627494|EG009|Reported Event|Part B: GSK3439171A 11 mg|Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339252|NCT03627494|EG010|Reported Event|Part B: GSK3439171A 40 mg|Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
11339253|NCT03627494|EG011|Reported Event|Part C: GSK3439171A 60 mg Fasted|Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2.
11339254|NCT03627494|EG012|Reported Event|Part C: GSK3439171A 60 mg Fed|Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2.
11339255|NCT03627767|BG000|Baseline|PF-04965842 200 mg OL to Placebo DB|Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339256|NCT03627767|BG001|Baseline|PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB|Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339257|NCT03627767|BG002|Baseline|PF-04965842 200 mg OL to PF-04965842 200 mg DB|Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339258|NCT03627767|BG003|Baseline|Total|Total of all reporting groups
11339991|NCT03643692|BG000|Baseline|ARISES|ARISES: The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform. Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support. Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios. Ultimately, ARISES aims to empower self-management of chronic illness and limit the complic
11340020|NCT03644173|OG000|Outcome|Personal Resilience Empowerment Program|Participants who were enrolled and attended at least one visit
11340021|NCT03644173|EG000|Reported Event|Personal Resilience Empowerment Program (All Visits and Follow up)|Participants who were enrolled, completed all visits and completed the two follow-up visits (1 month and 3 months post-op)
11340022|NCT03644173|EG001|Reported Event|Personal Resilience Empowerment Program (Visits Only)|Participants who were enrolled and completed the first three visits (but not follow-up)
11340023|NCT03644212|BG000|Baseline|Vitamin D Treatment|"Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.~Vitamin D3: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment."
11340024|NCT03644212|BG001|Baseline|Non Treated|Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
11340025|NCT03644212|BG002|Baseline|Total|Total of all reporting groups
11340026|NCT03644212|FG000|Participant Flow|Vitamin D Treatment|"Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.~Vitamin D3: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment."
11340027|NCT03644212|FG001|Participant Flow|Non Treated|Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
11340028|NCT03644212|OG000|Outcome|Vitamin D Treatment|"Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.~Vitamin D3: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment."
11340029|NCT03644212|OG001|Outcome|Non Treated|Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
11340030|NCT03644212|EG000|Reported Event|Vitamin D Treatment|"Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.~Vitamin D3: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment."
11340031|NCT03644212|EG001|Reported Event|Non Treated|Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
11340032|NCT03645421|BG000|Baseline|Placebo|Patients were randomised to receive MEDI0382 matched placebo for 48 days.
11340033|NCT03645421|BG001|Baseline|MEDI0382 100 mcg|Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days.
11340034|NCT03645421|BG002|Baseline|MEDI0382 200 mcg|Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days.
11340035|NCT03645421|BG003|Baseline|MEDI0382 300 mcg|Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days.
11340036|NCT03645421|BG004|Baseline|Total|Total of all reporting groups
11340037|NCT03645421|FG000|Participant Flow|Placebo|Patients were randomised to receive MEDI0382 matched placebo for 48 days.
11340038|NCT03645421|FG001|Participant Flow|MEDI0382 100 mcg|Patients were randomised to receive 100 micrograms (mcg) MEDI0382 per day by subcutaneous (SC) injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days.
11340039|NCT03645421|FG002|Participant Flow|MEDI0382 200 mcg|Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days.
11340040|NCT03645421|FG003|Participant Flow|MEDI0382 300 mcg|Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days.
11340041|NCT03645421|OG000|Outcome|Placebo|Patients were randomised to receive MEDI0382 matched placebo for 48 days.
11340042|NCT03645421|OG001|Outcome|MEDI0382 100 mcg|Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days.
11340043|NCT03645421|OG002|Outcome|MEDI0382 200 mcg|Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days.
11340044|NCT03645421|OG003|Outcome|MEDI0382 300 mcg|Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days.
11340045|NCT03645421|OG000|Outcome|MEDI0382 100 mcg|Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days.
11340046|NCT03645421|OG001|Outcome|MEDI0382 200 mcg|Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days.
11340047|NCT03645421|OG002|Outcome|MEDI0382 300 mcg|Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days.
10966721|NCT00888615|EG000|Reported Event|Treatment (Paclitaxel, Elesclomol Sodium)|"Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.~Elesclomol Sodium: Given IV~Paclitaxel: Given IV"
11340048|NCT03645421|EG000|Reported Event|Placebo|Patients were randomised to receive MEDI0382 matched placebo for 48 days.
10850758|NCT00304278|BG000|Baseline|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
11340049|NCT03645421|EG001|Reported Event|MEDI0382 100 mcg|Patients were randomised to receive 100 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days and then 100 mcg/day for 43 days.
11340050|NCT03645421|EG002|Reported Event|MEDI0382 200 mcg|Patients were randomised to receive 200 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days and then 200 mcg/day for 36 days.
11340051|NCT03645421|EG003|Reported Event|MEDI0382 300 mcg|Patients were randomised to receive 300 mcg MEDI0382 per day by SC injection, titrated as follows: 50 mcg/day for 5 days, 100 mcg/day for 7 days, 200 mcg/day for 7 days and then 300 mcg/day for 29 days.
11340052|NCT03645434|BG000|Baseline|All Participants|Subjects received AZD8871 inhalation powder 600 μg, 1 inhalation per day; umeclidinium 55 μg / vilanterol 22 μg. as oral inhalation once per day; Placebo to AZD8871 via oral inhalation, 1 inhalation per day.
11340053|NCT03645434|FG000|Participant Flow|Treatment Sequence A|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®."
11340054|NCT03645434|FG001|Participant Flow|Treatment Sequence B|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg."
11340055|NCT03645434|FG002|Participant Flow|Treatment Sequence C|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.~Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: Matching placebo of AZD8871 and Anoro® Ellipta®."
11340056|NCT03645434|FG003|Participant Flow|Treament Sequence D|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg.~Treatment period 2: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo."
11340057|NCT03645434|FG004|Participant Flow|Treatment Sequence E|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 600 μg and Anoro® Ellipta® matching placebo. Treatment period 3: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg."
11340058|NCT03645434|FG005|Participant Flow|Treatment Sequence F|"Randomized subjects received 14 repeated daily oral doses of inhalation powder via DPI as follows:~Treatment period 1: Matching placebo of AZD8871 and Anoro® Ellipta®. Treatment period 2: AZD8871 matching placebo and Anoro® Ellipta® 55 μg / 22 μg. Treatment period 3: AZD8871 600 μg and Anoro® Ellipta® matching placebo."
11340059|NCT03645434|OG000|Outcome|AZD8871|Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
11340060|NCT03645434|OG001|Outcome|Anoro® Ellipta®|Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
11340061|NCT03645434|OG002|Outcome|Placebo|Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
11340062|NCT03645434|EG000|Reported Event|AZD8871|Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F.
11340063|NCT03645434|EG001|Reported Event|Anoro® Ellipta®|Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E.
11340064|NCT03645434|EG002|Reported Event|Placebo|Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F.
11340065|NCT03645785|BG000|Baseline|Non-Stone Forming Cohort|"All 23 patients completed both interventions, and were used as their own control for baseline vs increased fluid/citrate intake comparisons in this cross over study.~The same cohort underwent the following 2 periods, and all participants competed both~Period 1: Normal drinking habits and diet. This was for a total of 24 hours (i.e. Day 1). Urine was collected throughout day 1~Period 2: Increased fluid intake and citrate supplement (I.e. day 2-4). Participants all were encouraged to double their baseline fluid intake compared to day 1, and drink 1 bottle of Poland Spring 16.9oz with 1 packet of True lemon per day. Urine was collected throughout day 4."
11340066|NCT03645785|FG000|Participant Flow|Non-Stone Forming|"All 23 patients completed both interventions, and were used as their own control for baseline vs increased fluid/citrate intake comparisons in this cross over study.~The same cohort underwent the following 2 periods, and all participants competed both~Period 1: Normal drinking habits and diet. This was for a total of 24 hours (i.e. Day 1). Urine was collected throughout day 1~Period 2: Increased fluid intake and citrate supplement (I.e. day 2-4). Participants all were encouraged to double their baseline fluid intake compared to day 1, and drink 1 bottle of Poland Spring 16.9oz with 1 packet of True lemon per day. Urine was collected throughout day 4."
11340067|NCT03645785|OG000|Outcome|5pm Void Post|increased fluid intake cohort 5p.m void
11340068|NCT03645785|OG001|Outcome|5p.m. Pre|normal fluid intake 5 p.m void
11340069|NCT03645785|OG002|Outcome|1-2 pm Post|void time post intervention
11340070|NCT03645785|OG003|Outcome|1-2pm Void Pre|void time pre intervention
11340071|NCT03645785|OG004|Outcome|9-10AM Post|void time post intervention
11340072|NCT03645785|OG005|Outcome|9-10AM Pre|void time pre intervention
11340073|NCT03645785|OG006|Outcome|First Void Pre|pre intervention, first void
11340074|NCT03645785|OG007|Outcome|First Void Post|post intervention post void
11340075|NCT03645785|OG000|Outcome|Day 1|(Baseline)
11340076|NCT03645785|OG001|Outcome|Day 2|(Increased Fluid + Citrate)
11340077|NCT03645785|OG002|Outcome|Day 3|(Increased Fluid + Citrate)
11340078|NCT03645785|OG003|Outcome|Day 4|(Increased Fluid + Citrate)
11340079|NCT03645785|EG000|Reported Event|Normal Drinking Habits|There were no adverse effects noted. Data was collected for the 4 day study period.
11340080|NCT03645785|EG001|Reported Event|Increased Fluid Intake and Citrate Supplementation|There were no adverse effects noted. Data was collected for the 4 day study period.
11340081|NCT03645811|BG000|Baseline|Implementation of Music Therapy|"For the music therapy, lecturers specializing in music therapy were consulted and accordingly a mahur maqam, an instrumental piece of traditional Turkish music played on the saz, was chosen. The mahur maqam has a descending scale, which has a relaxing impact as it moves along a 1-2 octave sound spectrum. It elicits feelings of joy and positivity, and immediately draws the attention of the listener, helping keep the mind clear. The mahur maqam belongs to the rast maqam family. Rast maqams are usually evocative of feelings of peacefulness, surrender, tranquility, trust, and mystical sentiments.~Music Therapy: Music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player."
11340082|NCT03645811|BG001|Baseline|Implementation of EFT|"The EFT application protocol was explained to the students with the help of the image in the picture for 5 minutes. The method was applied through the investigator tapping on their bodies and the students repeating the steps for three sessions. Each of the treatment sessions was approximately three minutes, resulting in a nine-minute treatment for intervention. Each EFT session was performed by following the steps below.~The content of each EFT session was as follows:~Preparation~Tapping Series~The Nine Gamut Sequence and Eye Movements~EFT: EFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions."
11340083|NCT03645811|BG002|Baseline|Control|For the control group, 15 minutes of free time was given.
11340084|NCT03645811|BG003|Baseline|Total|Total of all reporting groups
11340085|NCT03645811|FG000|Participant Flow|Music Therapy|"In the study, music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 15 minutes under the supervision of the investigators using an MP3 player.~Music Therapy: Music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player."
11340086|NCT03645811|FG001|Participant Flow|Emotional Freedom Technique|"The EFT application protocol was explained to the students with the help of the image in the picture. The method was applied through the investigators tapping on their bodies and the students repeating the steps.~EFT: EFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions."
11340087|NCT03645811|FG002|Participant Flow|Control|For the control group, 15 minutes of free time was given.
11340088|NCT03645811|OG000|Outcome|Music Therapy|"In the study, music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 15 minutes under the supervision of the investigators using an MP3 player.~Music Therapy: Music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player."
11340089|NCT03645811|OG001|Outcome|Emotional Freedom Technique|"The EFT application protocol was explained to the students with the help of the image in the picture. The method was applied through the investigators tapping on their bodies and the students repeating the steps.~EFT: EFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions."
11340090|NCT03645811|OG002|Outcome|Control|For the control group, 15 minutes of free time was given.
11340091|NCT03645811|EG000|Reported Event|Music Therapy|"For the music therapy, lecturers specializing in music therapy were consulted and accordingly a mahur maqam, an instrumental piece of traditional Turkish music played on the saz, was chosen. The students listened to this music for about 15 minutes. There was no adverse event during and after the intervention."
11340092|NCT03645811|EG001|Reported Event|Emotional Freedom Technique (EFT)|EFT was applied as follows: first, the researcher tapped on different parts of students' bodies and the students repeated the steps for three sessions. Each of the treatment sessions took approximately three minutes, nine minutes in total. There was no adverse event during and after the intervention.
11340093|NCT03645811|EG002|Reported Event|Control|For the control group, 15 minutes of free time was given. There was no adverse event during and after the intervention.
11340094|NCT03645954|BG000|Baseline|Femoral Nerve Block|The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
11340095|NCT03645954|BG001|Baseline|Femoral Triangle & Adductor Canal Blocks|These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
11340096|NCT03645954|BG002|Baseline|Total|Total of all reporting groups
11340097|NCT03645954|FG000|Participant Flow|Femoral Nerve Block|The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
11340098|NCT03645954|FG001|Participant Flow|Femoral Triangle & Adductor Canal Blocks|These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
11340099|NCT03645954|OG000|Outcome|Femoral Nerve Block|The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
11340100|NCT03645954|OG001|Outcome|Femoral Triangle & Adductor Canal Blocks|These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
11340101|NCT03645954|EG000|Reported Event|Femoral Nerve Block|"The femoral nerve block will be performed under the ultrasound guidance by a single injection of local anesthetic around all the femoral nerve branches inside the proximal part of the femoral triangle.~Femoral Nerve Block: Procedure: Femoral Nerve Block~The femoral nerve block will be performed as described in Arms section.~Device: Ultrasound~Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement.~Device: Needle~20-gauge 50 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral nerve block.~Drug: Local anesthetic~Bupivacaine 0.125% 20 mL will be used to perform the femoral nerve block."
11340102|NCT03645954|EG001|Reported Event|Femoral Triangle & Adductor Canal Blocks|"These two blocks will be performed together.~Firstly, the femoral triangle block will be performed under the ultrasound guidance by a single injection of local anesthetic at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery.~Secondly, the adductor canal block will be performed under the ultrasound guidance by a single injection of local anesthetic at the level where the femoral vessels (artery and vein) dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.~Femoral Triangle & Adductor Canal Blocks: Procedure: Femoral Triangle & Adductor Canal Blocks~These two blocks will be performed as described in Arms section.~Device: Ultrasound~Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement.~Device: Needle~20-gauge 100 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral triangle block and adductor canal block.~Drug: Local anesthetic~Bupivacaine 0.125% 20 mL will be used to perform the femoral triangle block and adductor canal block (10 mL for each block)."
11340103|NCT03646305|BG000|Baseline|Verbally Repeat Body-related Thoughts|"A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340104|NCT03646305|BG001|Baseline|Sing Negative Body-related Thoughts|"A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340105|NCT03646305|BG002|Baseline|Verbally Repeat Body-unrelated Thoughts|"A control condition in which participants repeat the phrase I am talking out loud and as quickly as possible for 60 seconds."
11340106|NCT03646305|BG003|Baseline|Sing Body-unrelated Thoughts|"A control condition in which participants sing the phrase I am singing to the tune of 'twinkle, twinkle' for 60 seconds"
11340107|NCT03646305|BG004|Baseline|Total|Total of all reporting groups
11340108|NCT03646305|FG000|Participant Flow|Verbally Repeat Body-related Thoughts|"A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340413|NCT03653351|OG000|Outcome|Sham tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.~Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes)."
11339270|NCT03627767|EG002|Reported Event|PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB|Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339271|NCT03627767|EG003|Reported Event|PF-04965842 200 mg OL to PF-04965842 200 mg DB|Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339272|NCT03627767|EG004|Reported Event|PF-04965842 200 mg Rescue Period|Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
11339273|NCT03627832|BG000|Baseline|CBT-I|"Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.~Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.~Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."
11339274|NCT03627832|BG001|Baseline|Sleep Hygiene|Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
11339275|NCT03627832|BG002|Baseline|Total|Total of all reporting groups
11339276|NCT03627832|FG000|Participant Flow|CBT-I|"Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.~Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.~Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."
11339277|NCT03627832|FG001|Participant Flow|Sleep Hygiene|Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
11339278|NCT03627832|OG000|Outcome|CBT-I|"Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.~Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.~Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."
11339279|NCT03627832|OG001|Outcome|Sleep Hygiene|Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
11339280|NCT03627832|EG000|Reported Event|CBT-I|"Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.~Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.~Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."
11339281|NCT03627832|EG001|Reported Event|Sleep Hygiene|Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
11339282|NCT03628417|BG000|Baseline|All Study Participants|All participants receiving Calcium Electroporation and Bleomycin Based Electrochemotherapy.
11339283|NCT03628417|FG000|Participant Flow|Calcium Electroporation|"Volume of calcium chloride (220 mmol/L) was dependent on tumor volume. Smaller tumors should have bigger volume per cm³, as smaller tumors were expected to have a bigger loss of injected medicine into the surrounding tissue.The dose volume was calculated according to the 'European Standard Operating Procedure of the Electrochemotherapy'.~Tumor < 0.5 cm³ - 1 ml/cm³ tumor volume~Tumor > 0.5 cm³ - 0,5 ml/cm³ tumor volume Tumor volume = ab²π/6 (a = longest diameter, b = longest diameter perpendicular to a) Biopsies were performed from the tumor area before and after electroporation. Maximum of 8 biopsies were done, depending on the patient's number of metastases. All patient's regardless of the number of metastases had one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code was revealed at day 180.~All biopsies were handled and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."
11339310|NCT03628599|OG000|Outcome|TOTAL1|Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
11339311|NCT03628599|OG001|Outcome|1-DAY|Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
11339312|NCT03628599|EG000|Reported Event|TOTAL1 Ocular - Right Eye|Right eyes exposed to delefilcon A contact lenses
11339313|NCT03628599|EG001|Reported Event|TOTAL1 Ocular - Left Eye|Left eyes exposed to delefilcon A contact lenses
11339314|NCT03628599|EG002|Reported Event|TOTAL1 Non-ocular|All subjects exposed to delefilcon A contact lenses
11339315|NCT03628599|EG003|Reported Event|1-DAY Ocular - Right Eye|Right eyes exposed to senofilcon A contact lenses
11339316|NCT03628599|EG004|Reported Event|1-DAY Ocular - Left Eye|Left eyes exposed to senofilcon A contact lenses
11339317|NCT03628599|EG005|Reported Event|1-DAY Non-ocular|All subjects exposed to senofilcon A contact lenses
11339318|NCT03628885|BG000|Baseline|General Vaccine Information|Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
11339319|NCT03628885|BG001|Baseline|Top Concern Tailored Intervention|"Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above. For those indicating #6, they will receive the same video as those indicating #1 (need more information).~Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns."
11339320|NCT03628885|BG002|Baseline|All Concerns Tailored Intervention|"Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above.~All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns."
11339321|NCT03628885|BG003|Baseline|Total|Total of all reporting groups
11339322|NCT03628885|FG000|Participant Flow|General Vaccine Information|Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
11339323|NCT03628885|FG001|Participant Flow|Top Concern Tailored Intervention|"Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above. For those indicating #6, they will receive the same video as those indicating #1 (need more information).~Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns."
11339324|NCT03628885|FG002|Participant Flow|All Concerns Tailored Intervention|"Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above.~All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns."
11339325|NCT03628885|OG000|Outcome|General Vaccine Information|Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
11339326|NCT03628885|OG001|Outcome|Top Concern Tailored Intervention|"Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above. For those indicating #6, they will receive the same video as those indicating #1 (need more information).~Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns."
11339327|NCT03628885|OG002|Outcome|All Concerns Tailored Intervention|"Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above.~All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns."
11339328|NCT03628885|EG000|Reported Event|General Vaccine Information|Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
11340125|NCT03646656|BG001|Baseline|Peer Coach|Veterans with at least one cardiovascular disease risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
11340126|NCT03646656|BG002|Baseline|Total|Total of all reporting groups
11242411|NCT02495259|FG001|Participant Flow|GlideScope With the GlideRite Stylet|"Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.~GlideScope: Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique. The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation. GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner."
11242412|NCT02495259|FG002|Participant Flow|Macintosh Blade and a Regular DLT Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
11242413|NCT02495259|OG000|Outcome|ZU-bend Stylet With GlideScope Technique|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
11242414|NCT02495259|OG001|Outcome|GlideScope With the GlideRite Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
11242415|NCT02495259|OG002|Outcome|Macintosh Blade and a Regular DLT Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
11340127|NCT03646656|FG000|Participant Flow|Reciprocal Peer Partner|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340128|NCT03646656|FG001|Participant Flow|Peer Coach|Veterans with at least one cardiovascular disease risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
11340129|NCT03646656|OG000|Outcome|Reciprocal Peer Partner|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340130|NCT03646656|OG001|Outcome|Peer Coach|Veterans with at least one cardiovascular disease risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
11340131|NCT03646656|OG000|Outcome|Reciprocal Peer Partner|Veterans with at least one CVD risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340132|NCT03646656|OG001|Outcome|Peer Coach|Veterans with at least one CVD risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
11340133|NCT03646656|OG000|Outcome|Reciprocal Peer Partner - Female|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340134|NCT03646656|OG001|Outcome|Reciprocal Peer Partner - Male|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340135|NCT03646656|EG000|Reported Event|Reciprocal Peer Partner|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340136|NCT03646656|EG001|Reported Event|Peer Coach|Veterans with at least one cardiovascular disease risk factor who have made and sustained changes in diet or exercise in the past 3-6 months prior to enrollment serve as peer coaches and provide supplemental one-way support to reciprocal peer partners as needed.
11340137|NCT03647033|BG000|Baseline|Phacoemulsification Alone|routine phacoemulsification cataract surgery with intraocular lens implantation
11340138|NCT03647033|BG001|Baseline|Phacoemulsification and iStent|"phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation~iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted."
11340139|NCT03647033|BG002|Baseline|Total|Total of all reporting groups
11340140|NCT03647033|FG000|Participant Flow|Phacoemulsification Alone|routine phacoemulsification cataract surgery with intraocular lens implantation
11340141|NCT03647033|FG001|Participant Flow|Phacoemulsification and iStent|"phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation~iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted."
11340142|NCT03647033|OG000|Outcome|Phacoemulsification Alone|routine phacoemulsification cataract surgery with intraocular lens implantation
11340143|NCT03647033|OG001|Outcome|Phacoemulsification and iStent|"phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation~iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted."
11340144|NCT03647033|EG000|Reported Event|Phacoemulsification Alone|routine phacoemulsification cataract surgery with intraocular lens implantation
11340145|NCT03647033|EG001|Reported Event|Phacoemulsification and iStent|"phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation~iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted."
11340146|NCT03647046|BG000|Baseline|Customized Scleral Lens|"A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.~Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens."
11242416|NCT02495259|EG000|Reported Event|ZU-bend Stylet With GlideScope Technique|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
11242417|NCT02495259|EG001|Reported Event|GlideScope With the GlideRite Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
11200075|NCT02190903|OG001|Outcome|Regional (Spinal) Anesthesia|"Standard care spinal anesthesia~Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen."
11200076|NCT02190903|EG000|Reported Event|General Endotracheal Anesthesia|"Standard care general endotracheal anesthesia~General endotracheal anesthesia: General Anesthesia~Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol."
11200077|NCT02190903|EG001|Reported Event|Regional (Spinal) Anesthesia|"Standard care spinal anesthesia~Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen."
11200078|NCT02191033|BG000|Baseline|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Text messaging~Nicotine patch"
11200079|NCT02191033|BG001|Baseline|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
11200080|NCT02191033|BG002|Baseline|Total|Total of all reporting groups
11200081|NCT02191033|FG000|Participant Flow|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
11200082|NCT02191033|FG001|Participant Flow|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
11200083|NCT02191033|OG000|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
11200084|NCT02191033|OG001|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
11200085|NCT02191033|EG000|Reported Event|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
11200086|NCT02191033|EG001|Reported Event|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
11200087|NCT02191046|BG000|Baseline|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
11200088|NCT02191046|BG001|Baseline|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
11200089|NCT02191046|BG002|Baseline|Total|Total of all reporting groups
11200090|NCT02191046|FG000|Participant Flow|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
11200091|NCT02191046|FG001|Participant Flow|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
11200092|NCT02191046|OG000|Outcome|Syringe 20 ml|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect
11200093|NCT02191046|OG001|Outcome|Squeezable Bottle|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
11200094|NCT02191046|EG000|Reported Event|Syringe 20 ml|record adverse event at baseline and daily adverse events until 2 weeks after treatment
11200095|NCT02191046|EG001|Reported Event|Squeezable Bottle|record adverse event at baseline and daily adverse events until 2 weeks after treatment
11200096|NCT02191137|BG000|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
11200097|NCT02191137|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
11200098|NCT02191137|OG000|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
11200099|NCT02191137|EG000|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
11200100|NCT02191267|BG000|Baseline|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200101|NCT02191267|BG001|Baseline|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200102|NCT02191267|BG002|Baseline|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200103|NCT02191267|BG003|Baseline|Total|Total of all reporting groups
11200104|NCT02191267|FG000|Participant Flow|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200105|NCT02191267|FG001|Participant Flow|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200106|NCT02191267|FG002|Participant Flow|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200107|NCT02191267|OG000|Outcome|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200108|NCT02191267|OG001|Outcome|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200109|NCT02191267|OG002|Outcome|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200110|NCT02191267|EG000|Reported Event|Presumed CTE Group|"Interventions administered to the Presumed CTE Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200111|NCT02191267|EG001|Reported Event|Control Group|"Interventions administered to the Control Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
11200112|NCT02191267|EG002|Reported Event|AD Dementia Group|"Interventions administered to the AD Dementia Group include: [F-18]-T807 PET Scan and [F18]-Florbetapir PET Scan.~[F18]-T807: [F18]-T807 PET Scan to measure tau deposition in the brain.~[F18]-Florbetapir: [F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain."
10804017|NCT04654351|BG000|Baseline|TAK-667 10-30 mg|TAK-667 five-weight-band dosing of up to maximum of 30 mg injection, SC, once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).00
11200113|NCT02191397|BG000|Baseline|Bupropion XL|In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200114|NCT02191397|BG001|Baseline|Escitalopram|In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200115|NCT02191397|BG002|Baseline|Total|Total of all reporting groups
11200116|NCT02191397|FG000|Participant Flow|Bupropion XL|In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200117|NCT02191397|FG001|Participant Flow|Escitalopram|In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200118|NCT02191397|OG000|Outcome|Bupropion XL|In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11242418|NCT02495259|EG002|Reported Event|Macintosh Blade and a Regular DLT Stylet|Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
11242419|NCT02495389|BG000|Baseline|Mirabegron|This arm comprises women who received mirabegron
11242420|NCT02495389|FG000|Participant Flow|Mirabegron|This arm comprises women who received mirabegron
10850759|NCT00304278|FG000|Participant Flow|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
11200119|NCT02191397|OG001|Outcome|Escitalopram|In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11242421|NCT02495389|OG000|Outcome|Mirabegron|This arm comprises women who received mirabegron
11242422|NCT02495389|EG000|Reported Event|Mirabegron|This arm comprises women who received mirabegron
11242423|NCT02495454|BG000|Baseline|Single Arm|6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101)
11242424|NCT02495454|FG000|Participant Flow|Single Arm|6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101) miniCHOP: an attenuated version of the standard CHOP, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
11242425|NCT02495454|OG000|Outcome|Single Arm|6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101)
11200120|NCT02191397|EG000|Reported Event|Bupropion XL|In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200121|NCT02191397|EG001|Reported Event|Escitalopram|In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
11200122|NCT02191579|BG000|Baseline|BOTOX®|155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
11200123|NCT02191579|BG001|Baseline|Topiramate|Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
11200124|NCT02191579|BG002|Baseline|Total|Total of all reporting groups
11200125|NCT02191579|FG000|Participant Flow|BOTOX®|155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
11200126|NCT02191579|FG001|Participant Flow|Topiramate/BOTOX®|Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
11200127|NCT02191579|OG000|Outcome|BOTOX®|155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
11200128|NCT02191579|OG001|Outcome|Topiramate|Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
11200129|NCT02191579|EG000|Reported Event|BOTOX®|"155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.~The 80 participants originally treated with topiramate who then received BOTOX® are included in this arm."
11200130|NCT02191579|EG001|Reported Event|Topiramate|Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks.
11242426|NCT02495454|OG000|Outcome|Single Arm|6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101) miniCHOP: an attenuated version of the standard CHOP, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
11200131|NCT02191605|BG000|Baseline|Electronic SBIRT (eSBIRT)|"Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant."
11242427|NCT02495454|EG000|Reported Event|Single Arm|"6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101).~NOTE: One SAE (atrial fibrillation) was recorded in patient excluded from analysis (not eligible for transformed lymphoma), exit before starting the 1st cycle of treatment."
10966722|NCT00888628|BG000|Baseline|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
11200132|NCT02191605|BG001|Baseline|Tailored Texting|"Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200133|NCT02191605|BG002|Baseline|eSBIRT & Texting|"Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200134|NCT02191605|BG003|Baseline|Assessment Only|Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
11200135|NCT02191605|BG004|Baseline|Screening Only|Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.
11200136|NCT02191605|BG005|Baseline|Total|Total of all reporting groups
11200137|NCT02191605|FG000|Participant Flow|Electronic SBIRT (eSBIRT)|"Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant."
11200138|NCT02191605|FG001|Participant Flow|Tailored Texting|"Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200139|NCT02191605|FG002|Participant Flow|eSBIRT & Texting|"Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200140|NCT02191605|FG003|Participant Flow|Assessment Only|Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
11339355|NCT03628924|EG006|Reported Event|Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)|Participants who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339356|NCT03629028|BG000|Baseline|Single Layer|uterus will be sutured by single layer
11200141|NCT02191605|FG004|Participant Flow|Screening Only|Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.
11200142|NCT02191605|OG000|Outcome|Electronic SBIRT (eSBIRT)|"Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant."
11339357|NCT03629028|BG001|Baseline|Double Layer|uterus will be sutured by double layer
11339358|NCT03629028|BG002|Baseline|Total|Total of all reporting groups
11339359|NCT03629028|FG000|Participant Flow|Single Layer|Age:18-45 Years,Only women who underwent cesarean section Inclusion Criteria:Primary cesarean, singleton pregnancy, Exclusion Criteria:Multiple pregnancy, History of any uterine surgery, wound healing diseases (insulin dependent diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease) Uterus will be sutured in locked single layer during cesarean Diagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
11242428|NCT02495467|BG000|Baseline|MED Placebo Then MED2005|Participants first receive MED Placebo to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).
10849951|NCT00299182|EG006|Reported Event|10 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11200143|NCT02191605|OG001|Outcome|Tailored Texting|"Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200144|NCT02191605|OG002|Outcome|eSBIRT & Texting|"Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200145|NCT02191605|OG003|Outcome|Assessment Only|Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
11200146|NCT02191605|OG004|Outcome|Screening Only|Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.
10966124|NCT00885703|FG006|Participant Flow|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966125|NCT00885703|OG000|Outcome|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966126|NCT00885703|OG001|Outcome|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966127|NCT00885703|OG002|Outcome|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966128|NCT00885703|OG003|Outcome|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
11200147|NCT02191605|EG000|Reported Event|Electronic SBIRT (eSBIRT)|"Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant."
11200148|NCT02191605|EG001|Reported Event|Tailored Texting|"Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11242429|NCT02495467|BG001|Baseline|MED2005 Then MED Placebo|Participants first receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED Placebo to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).
11242430|NCT02495467|BG002|Baseline|Total|Total of all reporting groups
11200149|NCT02191605|EG002|Reported Event|eSBIRT & Texting|"Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.~eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.~Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them."
11200150|NCT02191605|EG003|Reported Event|Assessment Only|Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
11200151|NCT02191605|EG004|Reported Event|Screening Only|Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.
11200152|NCT02191618|BG000|Baseline|WEB Aneurysm Embolization Device|"The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.~The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant."
11200153|NCT02191618|FG000|Participant Flow|WEB Aneurysm Embolization Device|"The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.~The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant."
11200154|NCT02191618|OG000|Outcome|WEB Aneurysm Embolization Device|"The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.~The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant."
11200155|NCT02191618|EG000|Reported Event|CEC Adjudicated Adverse Events Through 1-Year|"The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.~The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant."
11200156|NCT02191865|BG000|Baseline|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
11200157|NCT02191865|BG001|Baseline|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
11200158|NCT02191865|BG002|Baseline|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
11200159|NCT02191865|BG003|Baseline|Total|Total of all reporting groups
11200160|NCT02191865|FG000|Participant Flow|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
11200161|NCT02191865|FG001|Participant Flow|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
11200162|NCT02191865|FG002|Participant Flow|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
11200163|NCT02191865|OG000|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
10849952|NCT00299221|BG000|Baseline|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
11200164|NCT02191865|OG001|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
11200165|NCT02191865|OG002|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
11200166|NCT02191865|OG003|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
11200167|NCT02191865|OG001|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
11200168|NCT02191865|OG002|Outcome|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
11200169|NCT02191865|EG000|Reported Event|Child Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
11200170|NCT02191865|EG001|Reported Event|Child Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
11200171|NCT02191865|EG002|Reported Event|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
11200172|NCT02192099|BG000|Baseline|Rapastinel (GLYX-13) 225mg or 450 mg IV Administration|Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.
10849953|NCT00299221|BG001|Baseline|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
10849954|NCT00299221|BG002|Baseline|Total|Total of all reporting groups
11340147|NCT03647046|FG000|Participant Flow|Customized Scleral Lens|"A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.~Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens."
11340148|NCT03647046|OG000|Outcome|Customized Scleral Lens|"A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.~Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens."
11340149|NCT03647046|EG000|Reported Event|Customized Scleral Lens|"A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.~Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens."
11340150|NCT03647267|BG000|Baseline|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11340151|NCT03647267|BG001|Baseline|Sham|For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
11340152|NCT03647267|BG002|Baseline|Total|Total of all reporting groups
11340153|NCT03647267|FG000|Participant Flow|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11340154|NCT03647267|FG001|Participant Flow|Sham|For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
11340155|NCT03647267|OG000|Outcome|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11340156|NCT03647267|OG001|Outcome|Sham|For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
11340157|NCT03647267|OG000|Outcome|Pneumatic Vitreolysis|"Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.~Pneumatic Vitreolysis (C3F8 injection): Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina."
11340158|NCT03647267|OG001|Outcome|Observation|"Participants randomized to the observation group will receive a sham injection.~Observation: No intervention; sham injection only"
11340159|NCT03647267|EG000|Reported Event|Pneumatic Vitreolysis|"Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.~Pneumatic Vitreolysis (C3F8 injection): Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina."
11340160|NCT03647267|EG001|Reported Event|Observation|"Participants randomized to the observation group will receive a sham injection.~Observation: No intervention; sham injection only"
11340161|NCT03647475|BG000|Baseline|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent|"Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.~Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment."
11340162|NCT03647475|FG000|Participant Flow|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent|"Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.~Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment."
11340163|NCT03647475|OG000|Outcome|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent|"Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.~Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment."
11340164|NCT03647475|EG000|Reported Event|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent|"Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.~Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment."
11340165|NCT03647709|BG000|Baseline|Total Knee Arthroplasty|Number of patients that had total knee arthroplasty after meeting study inclusion criteria
11340166|NCT03647709|FG000|Participant Flow|Total Knee Arthoplasty|"All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center.~The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office."
11242431|NCT02495467|FG000|Participant Flow|MED Placebo Then MED2005|Participants first receive MED Placebo to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).
11200173|NCT02192099|FG000|Participant Flow|Rapastinel (GLYX-13) 225mg or 450 mg IV Administration|Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.
11200174|NCT02192099|OG000|Outcome|Rapastinel (GLYX-13) 225mg or 450 mg IV Administration|Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.
11200175|NCT02192099|EG000|Reported Event|Rapastinel (GLYX-13) 225mg or 450 mg IV Administration|Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.
11200176|NCT02192164|BG000|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician's discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
10849955|NCT00299221|FG000|Participant Flow|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
11200177|NCT02192164|FG000|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician's discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
10849956|NCT00299221|FG001|Participant Flow|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
11200178|NCT02192164|OG000|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
11200179|NCT02192164|OG001|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
11200180|NCT02192164|OG000|Outcome|Etanercept: Former Smoker + Smoker|Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
11200181|NCT02192164|EG000|Reported Event|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
11200182|NCT02192164|EG001|Reported Event|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
11200183|NCT02192190|BG000|Baseline|Placebo|Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
11200184|NCT02192190|BG001|Baseline|Celecoxib|Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
11200185|NCT02192190|BG002|Baseline|LY2951742 5 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
11200186|NCT02192190|BG003|Baseline|LY2951742 50 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
11200187|NCT02192190|BG004|Baseline|LY2951742 120 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
11200188|NCT02192190|BG005|Baseline|LY2951742 300 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
11200189|NCT02192190|BG006|Baseline|Total|Total of all reporting groups
11200190|NCT02192190|FG000|Participant Flow|Placebo|Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
11200191|NCT02192190|FG001|Participant Flow|Celecoxib|Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
11200192|NCT02192190|FG002|Participant Flow|LY2951742 5 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
11200193|NCT02192190|FG003|Participant Flow|LY2951742 50 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
11200194|NCT02192190|FG004|Participant Flow|LY2951742 120 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
11200195|NCT02192190|FG005|Participant Flow|LY2951742 300 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
11200196|NCT02192190|OG000|Outcome|Placebo|Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
11200197|NCT02192190|OG001|Outcome|Celecoxib|Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
11200198|NCT02192190|OG002|Outcome|LY2951742 5 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
11200199|NCT02192190|OG003|Outcome|LY2951742 50 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
11200200|NCT02192190|OG004|Outcome|LY2951742 120 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
11200201|NCT02192190|OG005|Outcome|LY2951742 300 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
11200202|NCT02192190|OG000|Outcome|Placebo|Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks
11200203|NCT02192190|EG000|Reported Event|Placebo|Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
11200204|NCT02192190|EG001|Reported Event|Celecoxib|Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
11200205|NCT02192190|EG002|Reported Event|LY2951742 5 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
11200206|NCT02192190|EG003|Reported Event|LY2951742 50 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
11200207|NCT02192190|EG004|Reported Event|LY2951742 120 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
11200208|NCT02192190|EG005|Reported Event|LY2951742 300 mg + Placebo|Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
11200209|NCT02192307|BG000|Baseline|Potassium Oxalate Gel|"Professional application~Potassium oxalate gel"
11200210|NCT02192307|BG001|Baseline|Potassium Oxalate Liquid|"Professional application~Potassium oxalate liquid"
11200211|NCT02192307|BG002|Baseline|Total|Total of all reporting groups
11200212|NCT02192307|FG000|Participant Flow|Dipotassium Oxalate Gel|"Professional application~DiPotassium oxalate"
11200213|NCT02192307|FG001|Participant Flow|Oxalic Acid Potassium Salt Liquid|"Professional application~Oxalic Acid Potassium Salt Liquid"
11200214|NCT02192307|OG000|Outcome|Potassium Oxalate Gel|"Professional application~Potassium oxalate"
11200215|NCT02192307|OG001|Outcome|Potassium Oxalate Liquid|"Professional application~Potassium oxalate"
11200216|NCT02192307|EG000|Reported Event|Potassium Oxalate Gel|"Professional application~Potassium oxalate gel"
11200217|NCT02192307|EG001|Reported Event|Potassium Oxalate Liquid|"Professional application~Potassium oxalate liquid"
11200218|NCT02192541|BG000|Baseline|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
11200219|NCT02192541|BG001|Baseline|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
11200220|NCT02192541|BG002|Baseline|Total|Total of all reporting groups
11200221|NCT02192541|FG000|Participant Flow|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
11200222|NCT02192541|FG001|Participant Flow|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
11200223|NCT02192541|OG000|Outcome|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
10800315|NCT02075320|FG000|Participant Flow|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis (s-DCT): The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest computed tomography (CT) and chest radiograph (CR). There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
10800316|NCT02075320|OG000|Outcome|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
10800317|NCT02075320|EG000|Reported Event|Stationary Digital Chest Tomosynthesis|"All patients will be included in the experimental group.~Stationary Digital Chest Tomosynthesis: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
10800318|NCT02007512|BG000|Baseline|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800319|NCT02007512|BG001|Baseline|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11242432|NCT02495467|FG001|Participant Flow|MED2005 Then MED Placebo|Participants first receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED Placebo to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).
11242433|NCT02495467|OG000|Outcome|MED Placebo|Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.
11200224|NCT02192541|OG001|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
11200225|NCT02192541|OG001|Outcome|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
11200226|NCT02192541|EG000|Reported Event|Dose Level 1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 4 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m^2 and ziv-aflibercept at 4 mg/kg.
11200227|NCT02192541|EG001|Reported Event|Dose Level -1: Ganetespib 100 mg/m^2 + Ziv-Aflibercept 3 mg/kg|Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was administered at a level of 100 mg/m^2 and ziv-aflibercept at 3 mg/kg.
11200228|NCT02192606|BG000|Baseline|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
11200229|NCT02192606|BG001|Baseline|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
11200230|NCT02192606|BG002|Baseline|Total|Total of all reporting groups
11200231|NCT02192606|FG000|Participant Flow|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
11200232|NCT02192606|FG001|Participant Flow|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
11200233|NCT02192606|OG000|Outcome|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
11200234|NCT02192606|OG001|Outcome|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
10800320|NCT02007512|BG002|Baseline|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10849957|NCT00299221|OG000|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
11242434|NCT02495467|OG001|Outcome|MED2005|Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
10804018|NCT04654351|FG000|Participant Flow|TAK-667 10-30 mg|TAK-667 five-weight-band dosing of up to maximum of 10-30 mg injection, subcutaneously (SC), once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).
11242435|NCT02495467|EG000|Reported Event|MED Placebo|Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.
11200235|NCT02192606|EG000|Reported Event|2D Laparoscopy|"The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy~2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy."
11200236|NCT02192606|EG001|Reported Event|3D Laparoscopy|"The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.~Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system."
11200237|NCT02192684|BG000|Baseline|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
11200238|NCT02192684|BG001|Baseline|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
11200239|NCT02192684|BG002|Baseline|Total|Total of all reporting groups
11200240|NCT02192684|FG000|Participant Flow|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
11200241|NCT02192684|FG001|Participant Flow|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
11200242|NCT02192684|OG000|Outcome|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
11200243|NCT02192684|OG001|Outcome|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
11200244|NCT02192684|EG000|Reported Event|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
11200245|NCT02192684|EG001|Reported Event|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
11200246|NCT02192814|BG000|Baseline|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
11200247|NCT02192814|FG000|Participant Flow|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
11200248|NCT02192814|OG000|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
11200249|NCT02192814|EG000|Reported Event|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
11242436|NCT02495467|EG001|Reported Event|MED2005|Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
11242437|NCT02495623|BG000|Baseline|Low Dose|21 mg SYN-010
11242438|NCT02495623|BG001|Baseline|High Dose|42 mg SYN-010
11242439|NCT02495623|BG002|Baseline|Placebo|Placebo
11242440|NCT02495623|BG003|Baseline|Total|Total of all reporting groups
11242441|NCT02495623|FG000|Participant Flow|Low Dose|21 mg SYN-010
11242442|NCT02495623|FG001|Participant Flow|High Dose|42 mg SYN-010
11242443|NCT02495623|FG002|Participant Flow|Placebo|Placebo
11242444|NCT02495623|OG000|Outcome|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
11242445|NCT02495623|OG001|Outcome|High Dose|"42 mg SYN-010~SYN-010 42 mg"
11242446|NCT02495623|OG002|Outcome|Placebo|"Placebo~Placebo"
11242447|NCT02495623|EG000|Reported Event|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
11242448|NCT02495623|EG001|Reported Event|High Dose|"42 mg SYN-010~SYN-010 42 mg"
11242449|NCT02495623|EG002|Reported Event|Placebo|"Placebo~Placebo"
11242450|NCT02495779|BG000|Baseline|Intervention|"Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence~emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.~CBT-based counseling: Brief CBT-based counseling to promote adherence"
11242451|NCT02495779|FG000|Participant Flow|Intervention|"Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence~emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.~CBT-based counseling: Brief CBT-based counseling to promote adherence"
11242452|NCT02495779|OG000|Outcome|Intervention|"Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence~emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.~CBT-based counseling: Brief CBT-based counseling to promote adherence"
11200250|NCT02192879|BG000|Baseline|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
11200251|NCT02192879|BG001|Baseline|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
11200252|NCT02192879|BG002|Baseline|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
11200253|NCT02192879|BG003|Baseline|Total|Total of all reporting groups
11200254|NCT02192879|FG000|Participant Flow|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
11242453|NCT02495779|EG000|Reported Event|Intervention|"Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence~emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.~CBT-based counseling: Brief CBT-based counseling to promote adherence"
10849958|NCT00299221|OG001|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
11242454|NCT02495831|BG000|Baseline|Intervention|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose"
11242455|NCT02495831|FG000|Participant Flow|Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
11242456|NCT02495831|FG001|Participant Flow|Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
10849959|NCT00299221|EG000|Reported Event|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
10849960|NCT00299221|EG001|Reported Event|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
11242457|NCT02495831|OG000|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
11242458|NCT02495831|OG001|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
11242459|NCT02495831|EG000|Reported Event|Diclofenac Sodium|Diclofenac sodium 50 mg oral tablets, single dose
11242460|NCT02495831|EG001|Reported Event|Diclofenac Sodium and Safinamide|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
11242461|NCT02495844|BG000|Baseline|Placebo/UCB0942|After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
11242462|NCT02495844|BG001|Baseline|UCB0942/UCB0942|Subjects received UCB0942.
11242463|NCT02495844|BG002|Baseline|Total Title|
11242464|NCT02495844|FG000|Participant Flow|Placebo/UCB0942|After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
11242465|NCT02495844|FG001|Participant Flow|UCB0942/UCB0942|Subjects received UCB0942.
11242466|NCT02495844|OG000|Outcome|Placebo/UCB0942 (FAS)|After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
11242467|NCT02495844|OG001|Outcome|UCB0942/UCB0942 (FAS)|Subjects received UCB0942.
11242468|NCT02495844|OG000|Outcome|Placebo/UCB0942 (SS)|After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
11242469|NCT02495844|OG001|Outcome|UCB0942/UCB0942 (SS)|Subjects received UCB0942.
11242470|NCT02495844|EG000|Reported Event|Placebo/UCB0942|After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
11242471|NCT02495844|EG001|Reported Event|UCB0942/UCB0942|Subjects received UCB0942.
11242472|NCT02495857|BG000|Baseline|Generic Hyaluronate Injectable, 1%|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242473|NCT02495857|BG001|Baseline|Euflexxa Injection 1%|Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242474|NCT02495857|BG002|Baseline|Vehicle Solution|Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
11242475|NCT02495857|BG003|Baseline|Total|Total of all reporting groups
11242476|NCT02495857|FG000|Participant Flow|Hyaluronate Injectable Viscosupplement|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242477|NCT02495857|FG001|Participant Flow|Euflexxa IA Injection|Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242478|NCT02495857|FG002|Participant Flow|Placebo Solution|Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
11242479|NCT02495857|OG000|Outcome|Generic Hyaluronate Injectable, 1%|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242480|NCT02495857|OG001|Outcome|Euflexxa Injection 1%|Patients received intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242481|NCT02495857|OG002|Outcome|Vehicle Solution|Patients received intra-articular (IA) injection of 2mL to the knee once weekly for 3 weeks.
11242482|NCT02495857|EG000|Reported Event|Generic Hyaluronate Injectable, 1%|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242483|NCT02495857|EG001|Reported Event|Euflexxa Injection 1%|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242484|NCT02495857|EG002|Reported Event|Vehicle Solution|Patients were administered intra-articular (IA) injection of 2 mL to the knee once weekly for 3 weeks.
11242485|NCT02495883|BG000|Baseline|Essential Tremor Group|"50ml of 40% ethanol will be administered to participants diagnosed with Essential Tremor.~Propranolol SR 60-120mg will be administered daily to participants over an estimated period of two weeks.~Ethanol: 50ml of 40% Ethanol~Propranolol: Beta blocker"
11242486|NCT02495883|BG001|Baseline|Health Volunteer Group|Healthy Volunteers
11242487|NCT02495883|BG002|Baseline|Total|Total of all reporting groups
11242488|NCT02495883|FG000|Participant Flow|Essential Tremor Group|"50ml of 40% ethanol will be administered to participants diagnosed with Essential Tremor.~Propranolol SR 60-120mg will be administered daily to participants over an estimated period of two weeks.~Ethanol: 50ml of 40% Ethanol~Propranolol: Beta blocker"
11242489|NCT02495883|FG001|Participant Flow|Health Volunteer Group|Healthy Volunteers
11242490|NCT02495883|OG000|Outcome|All Subjects|All subject data
11242491|NCT02495883|EG000|Reported Event|ET Group|Patient Cohort
11242492|NCT02495883|EG001|Reported Event|Healthy Volunteers|Control Cohort
11242493|NCT02495948|BG000|Baseline|Overall|Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11242494|NCT02495948|FG000|Participant Flow|AOA Then ULTRA|Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
11242495|NCT02495948|FG001|Participant Flow|ULTRA Then AOA|Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
11242496|NCT02495948|OG000|Outcome|AIR OPTIX AQUA (AOA)|Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
11242497|NCT02495948|OG001|Outcome|ULTRA|Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
11242498|NCT02495948|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11242499|NCT02495948|EG001|Reported Event|AIR OPTIX AQUA|All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2
11242500|NCT02495948|EG002|Reported Event|ULTRA|All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
11242501|NCT02496000|BG000|Baseline|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
11242502|NCT02496000|BG001|Baseline|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
11242503|NCT02496000|BG002|Baseline|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
11242504|NCT02496000|BG003|Baseline|Total|Total of all reporting groups
11242505|NCT02496000|FG000|Participant Flow|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
10849961|NCT00299416|BG000|Baseline|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
10849962|NCT00299416|FG000|Participant Flow|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
11242506|NCT02496000|FG001|Participant Flow|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
11242507|NCT02496000|FG002|Participant Flow|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
10966129|NCT00885703|OG004|Outcome|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
11242508|NCT02496000|OG000|Outcome|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
11242509|NCT02496000|OG001|Outcome|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
11242510|NCT02496000|OG002|Outcome|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
10849963|NCT00299416|OG000|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
10849964|NCT00299416|EG000|Reported Event|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
10849965|NCT00299494|BG000|Baseline|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849966|NCT00299494|BG001|Baseline|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11242511|NCT02496000|OG003|Outcome|ORMD-0801 Doses 1 and 2 Combined|The combined measurements of dose 1 and dose 2, in units of mg/dL
10849967|NCT00299494|BG002|Baseline|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11242512|NCT02496000|EG000|Reported Event|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
10850760|NCT00304278|OG000|Outcome|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
11200255|NCT02192879|FG001|Participant Flow|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
11200256|NCT02192879|FG002|Participant Flow|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
11200257|NCT02192879|OG000|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
11200258|NCT02192879|OG001|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
11200259|NCT02192879|OG002|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
11200260|NCT02192879|EG000|Reported Event|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
11200261|NCT02192879|EG001|Reported Event|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
11242513|NCT02496000|EG001|Reported Event|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
11242514|NCT02496000|EG002|Reported Event|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
11200262|NCT02192879|EG002|Reported Event|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
11242515|NCT02496091|BG000|Baseline|ATLANTIS Abutment|ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
11242516|NCT02496091|FG000|Participant Flow|ATLANTIS Abutment|ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
11242517|NCT02496091|OG000|Outcome|ATLANTIS Abutment|ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
11242518|NCT02496091|OG000|Outcome|ATLANTIS Abutment|ATLANTIS Abutment, component used in permanent dental prosthetic restorations.
11242519|NCT02496091|EG000|Reported Event|ATLANTIS Abutment|ATLANTIS Abutment, component used in permanent dental prosthetic restorations. Used for connecting the dental implant with the dental restoration.
10966130|NCT00885703|OG005|Outcome|Stage 2, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966131|NCT00885703|OG006|Outcome|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
11200263|NCT02192905|BG000|Baseline|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
11200264|NCT02192905|FG000|Participant Flow|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
10966132|NCT00885703|OG000|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
11200265|NCT02192905|OG000|Outcome|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
11200266|NCT02192905|OG000|Outcome|Behavioral Weight Loss + Habit|"Individuals randomized to this condition will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
11200267|NCT02192905|EG000|Reported Event|Behavioral Weight Loss + Habit|"Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.~Diabetes Prevention Program Lifestyle Intervention"
11200268|NCT02192970|BG000|Baseline|Bevacizumab|"Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.~Bevacizumab"
11200269|NCT02192970|BG001|Baseline|Chart Review|Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
11200270|NCT02192970|BG002|Baseline|Total|Total of all reporting groups
11200271|NCT02192970|FG000|Participant Flow|Bevacizumab|"Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.~Bevacizumab"
11200272|NCT02192970|FG001|Participant Flow|Chart Review|Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
11200273|NCT02192970|OG000|Outcome|Bevacizumab|"Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.~Bevacizumab"
11200274|NCT02192970|OG001|Outcome|Chart Review|Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
11200275|NCT02192970|EG000|Reported Event|Bevacizumab|"Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.~Bevacizumab"
11200276|NCT02192970|EG001|Reported Event|Chart Review|Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
11200277|NCT02193074|BG000|Baseline|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
11200278|NCT02193074|BG001|Baseline|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
11200279|NCT02193074|BG002|Baseline|Total|Total of all reporting groups
11200280|NCT02193074|FG000|Participant Flow|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
11200281|NCT02193074|FG001|Participant Flow|Nusinersen|Nusinersen (2.4 mg/mL) administered as an intrathecal (IT) lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
11200282|NCT02193074|OG000|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
11200283|NCT02193074|OG001|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
11200284|NCT02193074|EG000|Reported Event|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
11200285|NCT02193074|EG001|Reported Event|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
11242520|NCT02496221|BG000|Baseline|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
11200286|NCT02193087|BG000|Baseline|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
11200287|NCT02193087|BG001|Baseline|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200288|NCT02193087|BG002|Baseline|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200289|NCT02193087|BG003|Baseline|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200290|NCT02193087|BG004|Baseline|Total|Total of all reporting groups
11200291|NCT02193087|FG000|Participant Flow|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
11200292|NCT02193087|FG001|Participant Flow|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200293|NCT02193087|FG002|Participant Flow|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200294|NCT02193087|FG003|Participant Flow|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200295|NCT02193087|OG000|Outcome|Group A + Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
11200296|NCT02193087|OG001|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200297|NCT02193087|OG000|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200298|NCT02193087|OG000|Outcome|Group A + Group B Combined|"Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
11200299|NCT02193087|OG000|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
11200300|NCT02193087|OG001|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200301|NCT02193087|OG002|Outcome|Group A and Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
11200302|NCT02193087|OG003|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200303|NCT02193087|OG004|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200304|NCT02193087|OG002|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200305|NCT02193087|OG003|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200306|NCT02193087|EG000|Reported Event|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
11200307|NCT02193087|EG001|Reported Event|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200308|NCT02193087|EG002|Reported Event|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200309|NCT02193087|EG003|Reported Event|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
11200310|NCT02193152|BG000|Baseline|Treatment: Pazopanib|"Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.~One cycle of pazopanib is 28 days."
11200311|NCT02193152|FG000|Participant Flow|Treatment: Pazopanib|"Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.~One cycle of pazopanib is 28 days."
11200312|NCT02193152|OG000|Outcome|Treatment: Pazopanib|"Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.~One cycle of pazopanib is 28 days."
11200313|NCT02193152|EG000|Reported Event|Treatment: Pazopanib|"Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.~One cycle of pazopanib is 28 days."
11200314|NCT02193165|BG000|Baseline|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
10966133|NCT00885703|OG001|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966134|NCT00885703|OG002|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966135|NCT00885703|OG003|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966136|NCT00885703|EG000|Reported Event|Stage 1: 1200mg Fluconazole|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966137|NCT00885703|EG001|Reported Event|Stage 1: 1600mg Fluconazole|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966138|NCT00885703|EG002|Reported Event|Stage 1: 2000mg Fluconazole|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966139|NCT00885703|EG003|Reported Event|Stage 1: Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966140|NCT00885703|EG004|Reported Event|Stage 2: 1600mg Fluconazole|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966141|NCT00885703|EG005|Reported Event|Stage 2: 2000mg Fluconazole|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
10966142|NCT00885703|EG006|Reported Event|Stage 2: Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
10966143|NCT00885742|BG000|Baseline|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
10966144|NCT00885742|FG000|Participant Flow|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
10966145|NCT00885742|OG000|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
10966146|NCT00885742|EG000|Reported Event|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
10966147|NCT00885755|BG000|Baseline|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966148|NCT00885755|BG001|Baseline|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966149|NCT00885755|BG002|Baseline|No Group|This group included participants who died before any on study disease assessments or post-baseline biopsies. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
10966150|NCT00885755|BG003|Baseline|Total|Total of all reporting groups
10966151|NCT00885755|FG000|Participant Flow|Group A:Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 milligrams per square meter (mg/m^2) or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on Body Surface Area (BSA) on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966152|NCT00885755|FG001|Participant Flow|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
11200315|NCT02193165|BG001|Baseline|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
10966153|NCT00885755|FG002|Participant Flow|No Group|This group included participants who died before any study disease assessments or post-baseline biopsies. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
10966154|NCT00885755|OG000|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966155|NCT00885755|OG001|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966156|NCT00885755|OG000|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966157|NCT00885755|OG001|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966158|NCT00885755|OG000|Outcome|Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966159|NCT00885755|EG000|Reported Event|All Participants|In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Trastuzumab was administered according to SMPC. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
10966160|NCT00885768|BG000|Baseline|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
10966161|NCT00885768|FG000|Participant Flow|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
10966162|NCT00885768|OG000|Outcome|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
10850761|NCT00304278|EG000|Reported Event|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
10850762|NCT00304356|BG000|Baseline|Nitazoxanide|Patients with C. difficle who exhibit diarrhea and received nitazoxanide.
10850763|NCT00304356|FG000|Participant Flow|Nitazoxanide|
10850764|NCT00304356|OG000|Outcome|Nitazoxanide|time diarrhea from C. difficile stopped.
10850765|NCT00304356|EG000|Reported Event|Nitazoxanide|
10850766|NCT00304512|BG000|Baseline|Migalastat Low Dose 50 mg|Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850767|NCT00304512|BG001|Baseline|Migalastat Middle Dose 150 mg|Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850768|NCT00304512|BG002|Baseline|Migalastat High Dose 250 mg|Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850769|NCT00304512|BG003|Baseline|Total|Total of all reporting groups
10850770|NCT00304512|FG000|Participant Flow|Migalastat Low Dose 50 mg|Migalastat 50 milligrams (mg) was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850771|NCT00304512|FG001|Participant Flow|Migalastat Middle Dose 150 mg|Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850772|NCT00304512|FG002|Participant Flow|Migalastat High Dose 250 mg|Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850773|NCT00304512|OG000|Outcome|Migalastat Low Dose 50 mg|Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850774|NCT00304512|OG001|Outcome|Migalastat Middle Dose 150 mg|Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850775|NCT00304512|OG002|Outcome|Migalastat High Dose 250 mg|Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850776|NCT00304512|EG000|Reported Event|Migalastat Low Dose 50 mg|Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850777|NCT00304512|EG001|Reported Event|Migalastat Middle Dose 150 mg|Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850778|NCT00304512|EG002|Reported Event|Migalastat High Dose 250 mg|Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
10850779|NCT00304707|BG000|Baseline|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
10850780|NCT00304707|BG001|Baseline|Placebo|"placebo~placebo: placebo"
10850781|NCT00304707|BG002|Baseline|Total|Total of all reporting groups
10850782|NCT00304707|FG000|Participant Flow|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
10850783|NCT00304707|FG001|Participant Flow|Placebo|"placebo~placebo: placebo"
10850784|NCT00304707|OG000|Outcome|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
10850785|NCT00304707|OG001|Outcome|Placebo|"placebo~placebo: placebo"
10850786|NCT00304707|EG000|Reported Event|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
10850787|NCT00304707|EG001|Reported Event|Placebo|"placebo~placebo: placebo"
10850788|NCT00304746|BG000|Baseline|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
10850789|NCT00304746|BG001|Baseline|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
10850790|NCT00304746|BG002|Baseline|Total|Total of all reporting groups
10850791|NCT00304746|FG000|Participant Flow|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
10850792|NCT00304746|FG001|Participant Flow|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
10850793|NCT00304746|OG000|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
10850794|NCT00304746|OG001|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
10850795|NCT00304746|EG000|Reported Event|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
10850796|NCT00304746|EG001|Reported Event|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
10850944|NCT03410992|FG009|Participant Flow|Bimekizumab 320 mg Q4W/Q8W Escape|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
10850945|NCT03410992|FG010|Participant Flow|Bimekizumab 320 mg Q4W/Q4W Escape|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
10850946|NCT03410992|OG000|Outcome|Placebo (RS)|Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).
10966163|NCT00885768|EG000|Reported Event|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
10966164|NCT00885846|BG000|Baseline|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966165|NCT00885846|BG001|Baseline|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966166|NCT00885846|BG002|Baseline|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
10966167|NCT00885846|BG003|Baseline|Total|Total of all reporting groups
10966168|NCT00885846|FG000|Participant Flow|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966169|NCT00885846|FG001|Participant Flow|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966170|NCT00885846|FG002|Participant Flow|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
10966171|NCT00885846|OG000|Outcome|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966172|NCT00885846|OG001|Outcome|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
10966173|NCT00885846|OG002|Outcome|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
11200316|NCT02193165|BG002|Baseline|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
11200317|NCT02193165|BG003|Baseline|Total|Total of all reporting groups
11200318|NCT02193165|FG000|Participant Flow|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
11200319|NCT02193165|FG001|Participant Flow|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
11200320|NCT02193165|FG002|Participant Flow|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
11200321|NCT02193165|OG000|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
11200322|NCT02193165|OG001|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
10850797|NCT04721171|BG000|Baseline|Intervention Group|The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
11200323|NCT02193165|OG002|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
11200324|NCT02193165|EG000|Reported Event|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
11200325|NCT02193165|EG001|Reported Event|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
11200326|NCT02193165|EG002|Reported Event|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
11200327|NCT02193178|BG000|Baseline|Overall Baseline Characteristics|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
10850798|NCT04721171|BG001|Baseline|Placebo Group|The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days.
11200328|NCT02193178|FG000|Participant Flow|Overall Participants|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200329|NCT02193178|OG000|Outcome|Habitual Lenses|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200330|NCT02193178|OG001|Outcome|Comfilcon A - Baseline|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200331|NCT02193178|OG002|Outcome|Comfilcon A - 2 Weeks|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200332|NCT02193178|OG001|Outcome|Baseline|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200333|NCT02193178|OG002|Outcome|2 Weeks|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200334|NCT02193178|OG000|Outcome|Comfilcon A - Baseline|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200335|NCT02193178|OG001|Outcome|Comfilcon A - 2 Weeks|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200336|NCT02193178|OG000|Outcome|Conjunctival Staining (Baseline)|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200337|NCT02193178|OG001|Outcome|Conjunctival Indentation (Baseline)|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200338|NCT02193178|OG002|Outcome|Conjunctival Staining (2 Weeks)|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200339|NCT02193178|OG003|Outcome|Conjunctival Indentation (2 Weeks)|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200340|NCT02193178|OG000|Outcome|Comfilcon A- Baseline|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
10850799|NCT04721171|BG002|Baseline|Total|Total of all reporting groups
10966174|NCT00885846|EG000|Reported Event|Qigong Therapy|Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
10966175|NCT00885846|EG001|Reported Event|Progressive Resistance Training|Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
10966176|NCT00885846|EG002|Reported Event|Control|Wait list group; no activity at this arm. On list to start Qigong
10966177|NCT00886015|BG000|Baseline|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
11200341|NCT02193178|OG001|Outcome|Comfilcon A-2 Weeks|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200342|NCT02193178|OG000|Outcome|Comfilcon A Baseline|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200343|NCT02193178|OG001|Outcome|Comfilcon A 2 Weeks|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
11200344|NCT02193178|EG000|Reported Event|Comfilcon A Toric XR MTO|"Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.~comfilcon A Toric XR (MTO) contact lenses"
11200345|NCT02193347|BG000|Baseline|PEPIDH1M Vaccine|"PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.~PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.~Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.~Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles."
11200346|NCT02193347|FG000|Participant Flow|PEPIDH1M Vaccine|"PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.~PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.~Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.~Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles."
11200347|NCT02193347|OG000|Outcome|PEPIDH1M Vaccine|"PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.~PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.~Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.~Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles."
11242521|NCT02496221|FG000|Participant Flow|Albiglutide 50 mg Followed by Placebo|Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
10966178|NCT00886015|BG001|Baseline|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
10966179|NCT00886015|BG002|Baseline|Total|Total of all reporting groups
10850868|NCT04493931|EG006|Reported Event|Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg|Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 and Period 2 in Cohort 3.
10966180|NCT00886015|FG000|Participant Flow|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
10850869|NCT04493931|EG007|Reported Event|Cohort 4: Placebo|Japanese participants received a single oral dose of placebo matching gepotidacin under fed conditions in Period 1 or a single dose of placebo matching gepotidacin under fasted conditions in Period 2 or two doses of placebo (given 12 hours apart) matching gepotidacin under fed conditions in Period 3 in Cohort 4.
11242522|NCT02496221|FG001|Participant Flow|Placebo Followed by Albiglutide 50 mg|Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
11242523|NCT02496221|OG000|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10966181|NCT00886015|FG001|Participant Flow|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
10966182|NCT00886015|OG000|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
10966183|NCT00886015|OG001|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
10966184|NCT00886015|EG000|Reported Event|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
10966185|NCT00886015|EG001|Reported Event|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
11242524|NCT02496221|OG001|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10966186|NCT00886119|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
11242525|NCT02496221|OG000|Outcome|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of a cholecystokinin (sincalide) in each period.
11242526|NCT02496221|OG002|Outcome|Albiglutide 50 mg and Placebo|Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
11242527|NCT02496221|EG000|Reported Event|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
11242528|NCT02496221|EG001|Reported Event|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
11342460|NCT03707912|FG000|Participant Flow|Anaferon|"1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.~Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.~Anaferon: Oral administration."
11342461|NCT03707912|FG001|Participant Flow|Placebo|"Placebo using Anaferon regimen until the end of the study.~Placebo: Oral administration."
11342462|NCT03707912|OG000|Outcome|Anaferon|"1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.~Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.~Anaferon: Oral administration."
11342463|NCT03707912|OG001|Outcome|Placebo|"Placebo using Anaferon regimen until the end of the study.~Placebo: Oral administration."
11342464|NCT03707912|EG000|Reported Event|Anaferon|"1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.~Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.~Anaferon: Oral administration."
11342465|NCT03707912|EG001|Reported Event|Placebo|"Placebo using Anaferon regimen until the end of the study.~Placebo: Oral administration."
10966187|NCT00886119|FG000|Participant Flow|Lotrafilcon B / Omafilcon A|Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis.
10966188|NCT00886119|FG001|Participant Flow|Omafilcon A / Lotrafilcon B|Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
10966189|NCT00886119|OG000|Outcome|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear use
10966190|NCT00886119|OG001|Outcome|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
11242529|NCT02496533|BG000|Baseline|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
11242530|NCT02496533|BG001|Baseline|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
11242531|NCT02496533|BG002|Baseline|Total|Total of all reporting groups
10966191|NCT00886119|EG000|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear
10850870|NCT04493931|EG008|Reported Event|Cohort 4: Gepotidacin 1500 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
11242532|NCT02496533|FG000|Participant Flow|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10966192|NCT00886119|EG001|Reported Event|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
11242533|NCT02496533|FG001|Participant Flow|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10850871|NCT04493931|EG009|Reported Event|Cohort 4: Gepotidacin 1500 mg Fasted|Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
11202348|NCT02207244|FG007|Participant Flow|Guselkumab 100 mg (Week 28 - 264)|Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
10850872|NCT04493931|EG010|Reported Event|Cohort 4: Gepotidacin 3000 mg Fed|Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
10966193|NCT00886145|BG000|Baseline|Vibration- Right Leg and No Vibration-left Leg|"The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.~At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
11200348|NCT02193347|EG000|Reported Event|PEPIDH1M Vaccine|"PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.~PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.~Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.~Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles."
11200349|NCT02193490|BG000|Baseline|DNase|"DNase 0.1% eye drops four times a day for 8 weeks~DNase: DNase 0.1% eye drops four times a day for 8 weeks"
11200350|NCT02193490|BG001|Baseline|Vehicle|"Drug vehicle eye drops four times a day for 8 weeks~Vehicle: Drug vehicle eye drops four times a day for 8 weeks"
11200351|NCT02193490|BG002|Baseline|Total|Total of all reporting groups
11200352|NCT02193490|FG000|Participant Flow|DNase|"DNase 0.1% eye drops four times a day for 8 weeks~DNase: DNase 0.1% eye drops four times a day for 8 weeks"
11242534|NCT02496533|OG000|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10850275|NCT00301067|EG002|Reported Event|Cohort 3 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11200353|NCT02193490|FG001|Participant Flow|Vehicle|"Drug vehicle eye drops four times a day for 8 weeks~Vehicle: Drug vehicle eye drops four times a day for 8 weeks"
11200354|NCT02193490|OG000|Outcome|DNase|"DNase 0.1% eye drops four times a day for 8 weeks~DNase: DNase 0.1% eye drops four times a day for 8 weeks"
11200355|NCT02193490|OG001|Outcome|Vehicle|"Drug vehicle eye drops four times a day for 8 weeks~Vehicle: Drug vehicle eye drops four times a day for 8 weeks"
11200356|NCT02193490|EG000|Reported Event|DNase|"DNase 0.1% eye drops four times a day for 8 weeks~DNase: DNase 0.1% eye drops four times a day for 8 weeks"
11200357|NCT02193490|EG001|Reported Event|Vehicle|"Drug vehicle eye drops four times a day for 8 weeks~Vehicle: Drug vehicle eye drops four times a day for 8 weeks"
11200358|NCT02193776|BG000|Baseline|DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11242535|NCT02496533|OG001|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
11340167|NCT03647709|OG000|Outcome|Total Knee Arthoplasty|"All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center.~The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office."
11340168|NCT03647709|OG000|Outcome|No Opiates and Physical Therapy Adherence|Physical therapy adherence and non adherence for follow-up visits (1) post surgery days 10-14; (2) 3 weeks post surgery; (3) 6 weeks post surgery; (4) 12 weeks post surgery
11340169|NCT03647709|OG001|Outcome|Opiates and Physical Therapy Adherence|physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
11340170|NCT03647709|EG000|Reported Event|Total Knee Arthoplasty|"All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center.~The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office."
11340171|NCT03648853|BG000|Baseline|Intervention|All subjects received the same intervention
11340172|NCT03648853|FG000|Participant Flow|Intervention|All subjects received the same intervention
11340173|NCT03648853|OG000|Outcome|Intervention|All subjects received the same intervention
11340174|NCT03648853|EG000|Reported Event|Intervention|All subjects received the same intervention. There were no adverse effects
11340175|NCT03648879|BG000|Baseline|1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy|"Upper white-light endoscopy and confocal endoscopic microscopy~Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones."
11340176|NCT03648879|FG000|Participant Flow|1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy|"Upper white-light endoscopy and confocal endoscopic microscopy~Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones."
11340177|NCT03648879|OG000|Outcome|1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy|"Upper white-light endoscopy and confocal endoscopic microscopy~Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones."
11340178|NCT03648879|EG000|Reported Event|1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy|"Upper white-light endoscopy and confocal endoscopic microscopy~Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones."
11340179|NCT03649412|BG000|Baseline|MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast|Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent [%] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.
11340180|NCT03649412|BG001|Baseline|MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)|Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
11340181|NCT03649412|BG002|Baseline|Total|Total of all reporting groups
11340182|NCT03649412|FG000|Participant Flow|MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast|Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent [%] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.
11340892|NCT03669081|EG000|Reported Event|Toradol and Lyrica|"Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).~Ketorolac: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.~Pregabalin: Pregabalin was administered orally: 75 mg 30 minutes prior to operation."
10850877|NCT04262947|BG000|Baseline|Conventional Method|"Placement of peripheral venous catheter using conventional methods~Conventional IV placement: IV placement utilizing conventional methods"
11340213|NCT03649412|EG000|Reported Event|Part A: IR 240 mg Fasted|Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
11340214|NCT03649412|EG001|Reported Event|Part A: MR-12h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
11340215|NCT03649412|EG002|Reported Event|Part A: MR-18h 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
11340216|NCT03649412|EG003|Reported Event|Part A: MR-12h 240mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
11340217|NCT03649412|EG004|Reported Event|Part A: MR-18h 240mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
11340218|NCT03649412|EG005|Reported Event|Part A: MR-16h 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
11340219|NCT03649412|EG006|Reported Event|Part B: MR-16h 480mg Fasted|Participants received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340220|NCT03649412|EG007|Reported Event|Part B: MR-16h 480 mg Fed (Std)|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast (fed state)
11340221|NCT03649412|EG008|Reported Event|Part B: MR-16h 480mg Fed (High-fat)|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
11340222|NCT03649412|EG009|Reported Event|Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
11340223|NCT03649412|EG010|Reported Event|Part B: MR-16h 960mg Fasted|Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state
11340224|NCT03649412|EG011|Reported Event|Part B: MR-16h 120mg Fasted|Participants received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340225|NCT03649477|BG000|Baseline|9.6 mg of LV-101|"9.6 mg of LV-101 during the 8-week placebo-controlled period~9.6 mg intranasal carbetocin: three times per day with meals"
11340226|NCT03649477|BG001|Baseline|3.2 mg of LV-101|"3.2 mg of LV-101 during the 8-week placebo controlled period~3.2 mg intranasal carbetocin: three times per day with meals"
11340227|NCT03649477|BG002|Baseline|Placebo|"Matched intranasal placebo during the 8-week placebo controlled period~placebo: three times per day with meals"
11340228|NCT03649477|BG003|Baseline|Total|Total of all reporting groups
11340229|NCT03649477|FG000|Participant Flow|9.6 mg of LV-101|"9.6 mg of LV-101 during the 8-week placebo-controlled period~9.6 mg intranasal carbetocin: three times per day with meals"
11340230|NCT03649477|FG001|Participant Flow|3.2 mg of LV-101|"3.2 mg of LV-101 during the 8-week placebo controlled period~3.2 mg intranasal carbetocin: three times per day with meals"
11340231|NCT03649477|FG002|Participant Flow|Placebo|"Matched intranasal placebo during the 8-week placebo controlled period~placebo: three times per day with meals"
11340232|NCT03649477|OG000|Outcome|9.6 mg of LV-101|"9.6 mg of LV-101 during the 8-week placebo-controlled period~9.6 mg intranasal carbetocin: three times per day with meals"
11340233|NCT03649477|OG001|Outcome|3.2 mg of LV-101|"3.2 mg of LV-101 during the 8-week placebo controlled period~3.2 mg intranasal carbetocin: three times per day with meals"
11340234|NCT03649477|OG002|Outcome|Placebo|"Matched intranasal placebo during the 8-week placebo controlled period~placebo: three times per day with meals"
11340235|NCT03649477|EG000|Reported Event|9.6 mg of LV-101|"9.6 mg of LV-101 during the 8-week placebo controlled period~9.6 mg intranasal carbetocin: three times per day with meals"
11340236|NCT03649477|EG001|Reported Event|3.2 mg of LV-101|"3.2 mg of LV-101 during the 8-weeks placebo-controlled period~3.2 mg intranasal carbetocin: three times per day with meals"
11340237|NCT03649477|EG002|Reported Event|Placebo|"Matched intranasal placebo during 8-week placebo-controlled period~placebo: three times per day with meals"
11340238|NCT03649646|BG000|Baseline|Patients|Patients with hypertension uncontrolled by antihypertensive drug
11340239|NCT03649646|FG000|Participant Flow|Patients|Patients with hypertension uncontrolled by antihypertensive drug
11340240|NCT03649646|OG000|Outcome|Patients|Patients with hypertension uncontrolled by antihypertensive drug
11340241|NCT03649646|EG000|Reported Event|Patients|Patients with hypertension uncontrolled by antihypertensive drug
11340242|NCT03649750|BG000|Baseline|Pharmacokinetic (PK) Dataset|"Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.~Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.~Cohort 1~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug doses.~Cohort 2~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug doses."
11340243|NCT03649750|FG000|Participant Flow|Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2)|"Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.~Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.~Cohort 1~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug doses."
11340244|NCT03649750|FG001|Participant Flow|Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2)|"Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.~Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.~Cohort 2~Period 1 - Treatment A or Treatment B at Sequence AB.~Period 2 - Treatment B or Treatment A at Sequence BA.~Scheduled Washout of 7 days between drug doses."
11340245|NCT03649750|OG000|Outcome|Treatment A: Mucinex® 600 mg (Fast)|Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
11340246|NCT03649750|OG001|Outcome|Treatment B: Mucinex® 600 mg (Fed)|Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
10966194|NCT00886145|FG000|Participant Flow|Vibration: Right Leg and No Vibration: Left Leg|"The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g.~In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords."
10966195|NCT00886145|OG000|Outcome|Vibration- Right Leg|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
11340247|NCT03649750|OG000|Outcome|All Study Participants|Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting and fed.
11340248|NCT03649750|EG000|Reported Event|Treatment A: Mucinex® 600 mg (Fast)|Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
11340249|NCT03649750|EG001|Reported Event|Treatment B: Mucinex® 600 mg (Fed)|Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
11340250|NCT03649815|BG000|Baseline|Use of mHealth Technology|"This single arm of the study involves the provision of the mobile health technology entitled App4Independence.~App4Independence: The mobile, app-based platform was designed to:~Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement~Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)~Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness~Provide basic health/safety functionality and track level of wellness~Provide an anonymous peer-peer online network for strategy sharing~Provide an ambient sound detector to assist with identifying hallucinations"
11340251|NCT03649815|FG000|Participant Flow|Use of mHealth Technology|"This single arm of the study involves the provision of the mobile health technology entitled App4Independence.~App4Independence: The mobile, app-based platform was designed to:~Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement~Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)~Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness~Provide basic health/safety functionality and track level of wellness~Provide an anonymous peer-peer online network for strategy sharing~Provide an ambient sound detector to assist with identifying hallucinations"
11340252|NCT03649815|OG000|Outcome|Use of mHealth Technology|"This single arm of the study involves the provision of the mobile health technology entitled App4Independence.~App4Independence: The mobile, app-based platform was designed to:~Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement~Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)~Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness~Provide basic health/safety functionality and track level of wellness~Provide an anonymous peer-peer online network for strategy sharing~Provide an ambient sound detector to assist with identifying hallucinations"
11340253|NCT03649815|EG000|Reported Event|Use of mHealth Technology|"This single arm of the study involves the provision of the mobile health technology entitled App4Independence.~App4Independence: The mobile, app-based platform was designed to:~Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement~Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)~Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness~Provide basic health/safety functionality and track level of wellness~Provide an anonymous peer-peer online network for strategy sharing~Provide an ambient sound detector to assist with identifying hallucinations"
11340254|NCT03649867|BG000|Baseline|Semi-structured Interview|"Each female patient who attended the Survive & Thrive course designed for survivors of interpersonal trauma who meets the inclusion criteria will be invited to take part in a semi-structured interview. This interview will explore their experience of this psychoeducational course.~Semi-structured interviews: Each participant will attend a 30-45 minute semi-structured interview conducted by the CI"
11340255|NCT03649867|FG000|Participant Flow|Semi-structured Interview|"Each female patient who attended the Survive & Thrive course designed for survivors of interpersonal trauma who meets the inclusion criteria will be invited to take part in a semi-structured interview. This interview will explore their experience of this psychoeducational course.~Semi-structured interviews: Each participant will attend a 30-45 minute semi-structured interview conducted by the CI"
11340256|NCT03649867|OG000|Outcome|Semi-structured Interview|"Each female patient who attended the Survive & Thrive course designed for survivors of interpersonal trauma who meets the inclusion criteria will be invited to take part in a semi-structured interview. This interview will explore their experience of this psychoeducational course.~Semi-structured interviews: Each participant will attend a 30-45 minute semi-structured interview conducted by the CI"
11340257|NCT03649867|EG000|Reported Event|Semi-structured Interview|"Each female patient who attended the Survive & Thrive course designed for survivors of interpersonal trauma who meets the inclusion criteria will be invited to take part in a semi-structured interview. This interview will explore their experience of this psychoeducational course.~Semi-structured interviews: Each participant will attend a 30-45 minute semi-structured interview conducted by the CI"
11200359|NCT02193776|BG001|Baseline|DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200360|NCT02193776|BG002|Baseline|DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)|Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
11200361|NCT02193776|BG003|Baseline|MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide|Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200362|NCT02193776|BG004|Baseline|Total|Total of all reporting groups
10850878|NCT04262947|BG001|Baseline|VeinViewer Visualization Only|"Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement~Conventional IV placement: IV placement utilizing conventional methods"
11200363|NCT02193776|FG000|Participant Flow|DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 400 milligrams (mg) bedaquiline once daily on Days 1 to 14, 200 mg three times a week (t.i.w) during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200364|NCT02193776|FG001|Participant Flow|DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200365|NCT02193776|FG002|Participant Flow|DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)|Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kilograms (kg): 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
10850879|NCT04262947|BG002|Baseline|Constant Imaging With VeinViewer|"Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement"
10800321|NCT02007512|BG003|Baseline|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800322|NCT02007512|BG004|Baseline|Total|Total of all reporting groups
10800323|NCT02007512|FG000|Participant Flow|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10850880|NCT04262947|BG003|Baseline|Total|Total of all reporting groups
10850881|NCT04262947|FG000|Participant Flow|Conventional Method|"Placement of peripheral venous catheter using conventional methods~Conventional IV placement: IV placement utilizing conventional methods"
11200366|NCT02193776|FG003|Participant Flow|MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide|Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200367|NCT02193776|OG000|Outcome|DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200368|NCT02193776|OG001|Outcome|DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200369|NCT02193776|OG002|Outcome|DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)|Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
11200370|NCT02193776|OG003|Outcome|MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide|Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11242536|NCT02496533|EG000|Reported Event|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
11242537|NCT02496533|EG001|Reported Event|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10804019|NCT04654351|OG000|Outcome|TAK-667 10-30 mg|TAK-667 five-weight-band dosing of up to maximum of 30 mg injection, SC, once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).
10966196|NCT00886145|OG001|Outcome|No Vibration- Left Leg|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
10966197|NCT00886145|EG000|Reported Event|Vibration- Right Leg:|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
10966198|NCT00886145|EG001|Reported Event|No Vibration-left Leg:|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
10966199|NCT00886236|BG000|Baseline|1 Preoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966200|NCT00886236|BG001|Baseline|2 Preoperative and Postoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966201|NCT00886236|BG002|Baseline|3 Preoperative and Postoperative Placebo Liquid|"Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
11242538|NCT02496702|BG000|Baseline|Training|"The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.~The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).~Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles"
10966202|NCT00886236|BG003|Baseline|Total|Total of all reporting groups
11242539|NCT02496702|BG001|Baseline|Control|No training.
11242540|NCT02496702|BG002|Baseline|Total|Total of all reporting groups
11242541|NCT02496702|FG000|Participant Flow|Training|"The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.~The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).~Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles"
11242542|NCT02496702|FG001|Participant Flow|Control|No training.
11242543|NCT02496702|OG000|Outcome|Training|"The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.~The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).~Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles"
11242544|NCT02496702|OG001|Outcome|Control|No training.
10804020|NCT04654351|OG000|Outcome|TAK-667 10-30 mg|TAK-667 five-weight-band dosing of up to maximum of 30 mg injection, subcutaneously SC, once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).
10966203|NCT00886236|FG000|Participant Flow|1 Preoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966204|NCT00886236|FG001|Participant Flow|2 Preoperative and Postoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
11200371|NCT02193776|EG000|Reported Event|DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200372|NCT02193776|EG001|Reported Event|DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide|Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200373|NCT02193776|EG002|Reported Event|DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)|Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
11200374|NCT02193776|EG003|Reported Event|MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide|Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
11200375|NCT02193815|BG000|Baseline|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
11200376|NCT02193815|FG000|Participant Flow|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
11200377|NCT02193815|OG000|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
11200378|NCT02193815|OG001|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
11200379|NCT02193815|OG001|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
11200380|NCT02193815|OG000|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
11200381|NCT02193815|OG001|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
11200382|NCT02193815|OG001|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
11200383|NCT02193815|OG002|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
11200384|NCT02193815|OG003|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
11200385|NCT02193815|OG004|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
11200386|NCT02193815|OG005|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
11200387|NCT02193815|OG000|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
11200388|NCT02193815|EG000|Reported Event|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
11200389|NCT02193828|BG000|Baseline|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
11200390|NCT02193828|BG001|Baseline|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
11200391|NCT02193828|BG002|Baseline|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
11200392|NCT02193828|BG003|Baseline|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
11200393|NCT02193828|BG004|Baseline|Total|Total of all reporting groups
11200394|NCT02193828|FG000|Participant Flow|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
11200395|NCT02193828|FG001|Participant Flow|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
11200396|NCT02193828|FG002|Participant Flow|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
11200397|NCT02193828|FG003|Participant Flow|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
11200398|NCT02193828|OG000|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
11200399|NCT02193828|OG001|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
11200400|NCT02193828|OG002|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
11200401|NCT02193828|OG003|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
11200402|NCT02193828|EG000|Reported Event|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
11200403|NCT02193828|EG001|Reported Event|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
11200404|NCT02193828|EG002|Reported Event|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
11200405|NCT02193828|EG003|Reported Event|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
11200406|NCT02193880|BG000|Baseline|Alpha-beta Depleted T-cell Infusion|"Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.~Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide."
11200407|NCT02193880|FG000|Participant Flow|Alpha-beta Depleted T-cell Infusion|"Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.~Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide."
11200408|NCT02193880|OG000|Outcome|Alpha-beta Depleted T-cell Infusion|"Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.~Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide."
11200409|NCT02193880|EG000|Reported Event|Alpha-beta Depleted T-cell Infusion|"Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.~Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide."
11200410|NCT02194062|BG000|Baseline|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
10800324|NCT02007512|FG001|Participant Flow|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11200411|NCT02194062|BG001|Baseline|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
10800325|NCT02007512|FG002|Participant Flow|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11200412|NCT02194062|BG002|Baseline|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
11200413|NCT02194062|BG003|Baseline|Total|Total of all reporting groups
11200414|NCT02194062|FG000|Participant Flow|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
10850276|NCT00301067|EG003|Reported Event|Expansion - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11200415|NCT02194062|FG001|Participant Flow|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
11200416|NCT02194062|FG002|Participant Flow|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
11340893|NCT03669081|EG001|Reported Event|Placebo and Standard of Care|"Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.~Placebo oral capsule: Placebo oral capsule was administered orally 30 minutes prior to operation.~Saline: Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively."
11340894|NCT03669354|BG000|Baseline|Cohort SMT|Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
11340895|NCT03669354|BG001|Baseline|Cohort OAT|Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
11340896|NCT03669354|BG002|Baseline|Cohort SMTX|Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
11340897|NCT03669354|BG003|Baseline|Cohort OATX|Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
11340898|NCT03669354|BG004|Baseline|Total|Total of all reporting groups
11340899|NCT03669354|FG000|Participant Flow|Cohort SMT|Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
11340900|NCT03669354|FG001|Participant Flow|Cohort OAT|Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
11340901|NCT03669354|FG002|Participant Flow|SMTX|Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
11340902|NCT03669354|FG003|Participant Flow|OATX|Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
11340903|NCT03669354|OG000|Outcome|Cohort SMT|Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
11340904|NCT03669354|OG001|Outcome|Cohort OAT|Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
11340905|NCT03669354|OG002|Outcome|Cohort SMTX|Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
11340906|NCT03669354|OG003|Outcome|Cohort OATX|Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
11340907|NCT03669354|OG003|Outcome|Cohort OATX|Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
11340908|NCT03669354|EG000|Reported Event|Cohort SMT|Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
11340909|NCT03669354|EG001|Reported Event|Cohort OAT|Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
11340910|NCT03669354|EG002|Reported Event|Cohort SMTX|Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
11340911|NCT03669354|EG003|Reported Event|Cohort OATX|Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
11340912|NCT03669549|BG000|Baseline|Nevanimibe HCl|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340913|NCT03669549|FG000|Participant Flow|Nevanimibe HCl|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340914|NCT03669549|OG000|Outcome|Nevanimibe HCl|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340915|NCT03669549|EG000|Reported Event|Nevanimibe HCl Dose Level: <500 mg BID|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340916|NCT03669549|EG001|Reported Event|Nevanimibe HCl Dose Level:500 to <1000 mg BID|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340917|NCT03669549|EG002|Reported Event|Nevanimibe HCl Dose Level: 1000 to <1500 mg BID|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340918|NCT03669549|EG003|Reported Event|Nevanimibe HCl Dose Level: 1500 to <2000 mg BID|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340919|NCT03669549|EG004|Reported Event|Nevanimibe HCl Dose Level:2000 mg BID|"Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID~Nevanimibe hydrochloride: During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks."
11340920|NCT03669861|BG000|Baseline|Abatacept|To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD. Abatacept: Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks). The protocol called for a final study visit at 36 weeks, three months after the patients discontinued their active treatment, primarily for safety
10850277|NCT00301366|BG000|Baseline|Entered Study|
10850278|NCT00301366|FG000|Participant Flow|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
10850279|NCT00301366|OG000|Outcome|Alpha-1 MP Treatment Group|
11340921|NCT03669861|FG000|Participant Flow|Abatacept|"To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD~Abatacept: Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks)"
10850280|NCT00301366|EG000|Reported Event|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
11340922|NCT03669861|OG000|Outcome|Abatacept|"To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD~Abatacept: Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks)"
11340923|NCT03669861|EG000|Reported Event|Abatacept|"To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD~Abatacept: Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks)"
11340924|NCT03670017|BG000|Baseline|Time In Range During OptiScanner Connection|"Participants will be connected to the OptiScanner 5000 for up to 72 hours.~OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed."
11340925|NCT03670017|FG000|Participant Flow|Time In Range During OptiScanner Connection|"Participants will be connected to the OptiScanner 5000 for up to 72 hours.~OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed."
11340926|NCT03670017|OG000|Outcome|Time In Range During OptiScanner Connection|"Participants will be connected to the OptiScanner 5000 for up to 72 hours.~OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed."
11340927|NCT03670017|EG000|Reported Event|Time In Range During OptiScanner Connection|"Participants will be connected to the OptiScanner 5000 for up to 72 hours.~OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed."
11340928|NCT03670030|BG000|Baseline|ABI-009|"In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.~ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)"
11340929|NCT03670030|FG000|Participant Flow|ABI-009|"In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.~ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)"
11340930|NCT03670030|OG000|Outcome|ABI-009|"In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.~ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)"
11340931|NCT03670030|EG000|Reported Event|ABI-009|"In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.~ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)"
11340932|NCT03670160|BG000|Baseline|Phenobarbital|"Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.~Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge."
11340933|NCT03670160|BG001|Baseline|Clonidine|"Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.~Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine."
11340934|NCT03670160|BG002|Baseline|Total|Total of all reporting groups
11340935|NCT03670160|FG000|Participant Flow|Phenobarbital|"Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.~Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge."
11340936|NCT03670160|FG001|Participant Flow|Clonidine|"Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.~Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine."
10804021|NCT04654351|EG000|Reported Event|TAK-667 10-30 mg|TAK-667 five-weight-band dosing of up to maximum of 30 mg injection, SC, once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).
11242545|NCT02496702|EG000|Reported Event|Training|"The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.~The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).~Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles"
11242546|NCT02496702|EG001|Reported Event|Control|No training.
11242547|NCT02496767|BG000|Baseline|Double-blind, Placebo-controlled: Group 1 - Placebo|Day 1 through Week 48: 2 placebo tablets twice daily
11242548|NCT02496767|BG001|Baseline|Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv|Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM
11242549|NCT02496767|BG002|Baseline|Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242550|NCT02496767|BG003|Baseline|Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242551|NCT02496767|BG004|Baseline|Total|Total of all reporting groups
11242552|NCT02496767|FG000|Participant Flow|Open-label Lead-in: 250 mg Tirasemtiv|Open-label tirasemiv (125 mg twice daily) for 2 weeks
11242553|NCT02496767|FG001|Participant Flow|Double-blind, Placebo-controlled: Group 1 - Placebo|Day 1 through Week 48: 2 placebo tablets twice daily
11242554|NCT02496767|FG002|Participant Flow|Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv|Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM
11242555|NCT02496767|FG003|Participant Flow|Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv|Day 1 through Week 2: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242556|NCT02496767|FG004|Participant Flow|Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242557|NCT02496767|FG005|Participant Flow|Double-blind, Withdrawal: Placebo|Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.
11242558|NCT02496767|FG006|Participant Flow|Double-blind, Withdrawal: Tirasemtiv to Placebo|Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.
11242559|NCT02496767|FG007|Participant Flow|Double-blind, Withdrawal: Tirasemtiv|Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
11242560|NCT02496767|OG000|Outcome|Double-blind, Placebo-controlled: Group 1 - Placebo|Day 1 through Week 48: 2 placebo tablets twice daily
11242561|NCT02496767|OG001|Outcome|Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv|Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM
10804022|NCT04422990|BG000|Baseline|Biofinity|Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
11242562|NCT02496767|OG002|Outcome|Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242563|NCT02496767|OG003|Outcome|Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11242564|NCT02496767|EG000|Reported Event|Open-label Lead-in: 250 mg Tirasemtiv|Open-label tirasemiv (125 mg twice daily) for 2 weeks
11242565|NCT02496767|EG001|Reported Event|Double-blind, Placebo-controlled: Group 1 - Placebo|Day 1 through Week 48: 2 placebo tablets twice daily
11242566|NCT02496767|EG002|Reported Event|Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv|Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM
11200417|NCT02194062|OG000|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
11200418|NCT02194062|OG001|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
11200419|NCT02194062|OG002|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
11200420|NCT02194062|EG000|Reported Event|Fluticasone Group|Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
11200421|NCT02194062|EG001|Reported Event|Budesonide Respule in Head Upright|Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
11200422|NCT02194062|EG002|Reported Event|Budesonide Head Forward|budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
11200423|NCT02194088|BG000|Baseline|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
11200424|NCT02194088|BG001|Baseline|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
11200425|NCT02194088|BG002|Baseline|Total|Total of all reporting groups
10850328|NCT00302042|FG001|Participant Flow|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
11200426|NCT02194088|FG000|Participant Flow|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
11200427|NCT02194088|FG001|Participant Flow|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
11200428|NCT02194088|OG000|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
11200429|NCT02194088|OG001|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
11200430|NCT02194088|OG000|Outcome|Pain Medication:Diclofenac an Atropine|
11200431|NCT02194088|OG001|Outcome|Placebo|
10804023|NCT04422990|BG001|Baseline|LID018869|Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
10804024|NCT04422990|BG002|Baseline|Total|Total of all reporting groups
10966205|NCT00886236|FG002|Participant Flow|3 Preoperative and Postoperative Placebo Liquid|"Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
11200432|NCT02194088|EG000|Reported Event|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
11200433|NCT02194088|EG001|Reported Event|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
11200434|NCT02194439|BG000|Baseline|Hematopoietic Stem Cell Transplant|4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
10966206|NCT00886236|OG000|Outcome|1 Preoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
11200435|NCT02194439|FG000|Participant Flow|Hematopoietic Stem Cell Transplant|4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
11200436|NCT02194439|OG000|Outcome|Hematopoietic Stem Cell Transplant|4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
11200437|NCT02194439|EG000|Reported Event|Hematopoietic Stem Cell Transplant|4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
11200438|NCT02194465|BG000|Baseline|Placebo|Placebo for blinding administered orally once daily for 4 weeks.
11200439|NCT02194465|BG001|Baseline|6 mg LY2623091|6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200440|NCT02194465|BG002|Baseline|13 mg LY2623091|13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200441|NCT02194465|BG003|Baseline|24.5 mg LY2623091|24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200442|NCT02194465|BG004|Baseline|13 mg LY2623091 + 20 mg Tadalafil|13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200443|NCT02194465|BG005|Baseline|20 mg Tadalafil|20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200444|NCT02194465|BG006|Baseline|Spironolactone|25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
11200445|NCT02194465|BG007|Baseline|Total|Total of all reporting groups
11200446|NCT02194465|FG000|Participant Flow|Placebo|Placebo for blinding administered orally once daily for 4 weeks.
11200447|NCT02194465|FG001|Participant Flow|6 Milligrams (mg) LY2623091|6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200448|NCT02194465|FG002|Participant Flow|13 mg LY2623091|13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200449|NCT02194465|FG003|Participant Flow|24.5 mg LY2623091|24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200450|NCT02194465|FG004|Participant Flow|13 mg LY2623091 + 20 mg Tadalafil|13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200451|NCT02194465|FG005|Participant Flow|20 mg Tadalafil|20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200452|NCT02194465|FG006|Participant Flow|Spironolactone|25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
11200453|NCT02194465|OG000|Outcome|Placebo|Placebo for blinding administered orally once daily for 4 weeks.
11200454|NCT02194465|OG001|Outcome|6 mg LY2623091|6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200455|NCT02194465|OG002|Outcome|13 mg LY2623091|13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
10850329|NCT00302042|OG000|Outcome|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
11200456|NCT02194465|OG003|Outcome|24.5 mg LY2623091|24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200457|NCT02194465|OG004|Outcome|13 mg LY2623091 + 20 mg Tadalafil|13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200458|NCT02194465|OG005|Outcome|20 mg Tadalafil|20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200459|NCT02194465|OG006|Outcome|Spironolactone|25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
11200460|NCT02194465|OG000|Outcome|6 mg LY2623091|6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200461|NCT02194465|OG001|Outcome|13 mg LY2623091|13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200462|NCT02194465|OG002|Outcome|24.5 mg LY2623091|24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200463|NCT02194465|OG003|Outcome|13 mg LY2623091 + 20 mg Tadalafil|13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200464|NCT02194465|EG000|Reported Event|Placebo|Placebo for blinding administered orally once daily for 4 weeks.
11200465|NCT02194465|EG001|Reported Event|6 mg LY2623091|6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200466|NCT02194465|EG002|Reported Event|13 mg LY2623091|13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200467|NCT02194465|EG003|Reported Event|24.5 mg LY2623091|24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
11200468|NCT02194465|EG004|Reported Event|13 mg LY2623091 + 20 mg Tadalafil|13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200469|NCT02194465|EG005|Reported Event|20 mg Tadalafil|20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
11200470|NCT02194465|EG006|Reported Event|Spironolactone|25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
11200471|NCT02194621|BG000|Baseline|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
11200472|NCT02194621|BG001|Baseline|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
11200473|NCT02194621|BG002|Baseline|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
11200474|NCT02194621|BG003|Baseline|Total|Total of all reporting groups
11200475|NCT02194621|FG000|Participant Flow|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
11200476|NCT02194621|FG001|Participant Flow|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
11200477|NCT02194621|FG002|Participant Flow|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
10850330|NCT00302042|OG001|Outcome|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
10850331|NCT00302042|EG000|Reported Event|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
11200478|NCT02194621|OG000|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
11200479|NCT02194621|OG001|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
11200480|NCT02194621|OG002|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
11200481|NCT02194621|EG000|Reported Event|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
11200482|NCT02194621|EG001|Reported Event|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
11200483|NCT02194621|EG002|Reported Event|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
11200484|NCT02194699|BG000|Baseline|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200485|NCT02194699|BG001|Baseline|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200486|NCT02194699|BG002|Baseline|Total|Total of all reporting groups
11200487|NCT02194699|FG000|Participant Flow|Tralo 300 mg Q2W|Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 52-week treatment period (up to 26 doses).
11200488|NCT02194699|FG001|Participant Flow|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200489|NCT02194699|OG000|Outcome|Biomarker Positive - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
11200490|NCT02194699|OG001|Outcome|Biomarker Positive - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.
11200491|NCT02194699|OG002|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
11200492|NCT02194699|OG003|Outcome|Biomarker Negative - Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
11200493|NCT02194699|OG004|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200494|NCT02194699|OG005|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200495|NCT02194699|OG001|Outcome|Biomarker Negative - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO <37 ppb.
11200496|NCT02194699|OG002|Outcome|Total - Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). 'Total' treatment arm represents all patients receiving tralokinumab in both the biomarker positive and biomarker negative patient populations.
11200497|NCT02194699|OG000|Outcome|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200498|NCT02194699|OG001|Outcome|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200499|NCT02194699|EG000|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200500|NCT02194699|EG001|Reported Event|Placebo|Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
11200501|NCT02194933|BG000|Baseline|Brexpiprazole 2 mg|Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
11200502|NCT02194933|BG001|Baseline|Brexpiprazole 4 mg|Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
11200503|NCT02194933|BG002|Baseline|Total|Total of all reporting groups
11200504|NCT02194933|FG000|Participant Flow|Brexpiprazole 2 mg|Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
11200505|NCT02194933|FG001|Participant Flow|Brexpiprazole 4 mg|Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
11200506|NCT02194933|OG000|Outcome|Brexpiprazole 2 mg|Participants received Brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day until week 6 (Day 42)/early termination (ET)
11200507|NCT02194933|OG001|Outcome|Brexpiprazole 4 mg|Participants received brexpiprazole 1 mg orally per day for 4 days followed by 2 mg per day for 3 days, 3 mg per day for 7 days and 4 mg per day until week 6 (Day 42)/ET.
10804025|NCT04422990|FG000|Participant Flow|Biofinity|Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
11200508|NCT02194933|OG000|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2 mg/day, once daily dose, tablet, orally~Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks"
11200509|NCT02194933|OG001|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4 mg/day, once daily dose, tablet, orally~Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks"
11200510|NCT02194933|EG000|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2 mg/day, once daily dose, tablet, orally~Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks"
11200511|NCT02194933|EG001|Reported Event|Brexpiprazole 4 mg|"Brexpiprazole 4 mg/day, once daily dose, tablet, orally~Brexpiprazole: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks"
11200512|NCT02194985|BG000|Baseline|Migalastat HCl 150 mg|Migalastat HCl 150 mg was administered orally once every other day for a median duration of 3.1 years (ranged from approximately 1 month to 4.3 years).
11200513|NCT02194985|FG000|Participant Flow|Migalastat HCl 150 mg|Migalastat hydrochloride (HCl) 150 milligram (mg) was administered orally once every other day for a median duration of 3.1 years (ranged from approximately 1 month to 4.3 years).
11200514|NCT02194985|OG000|Outcome|Migalastat HCl 150 mg|Migalastat HCl 150 mg was administered orally once every other day for a median duration of 3.1 years (ranged from approximately 1 month to 4.3 years).
11200515|NCT02194985|EG000|Reported Event|Migalastat HCl 150 mg|Migalastat HCl 150 mg was administered orally every other day.
11200516|NCT02194998|BG000|Baseline|Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200517|NCT02194998|BG001|Baseline|Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200518|NCT02194998|BG002|Baseline|Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200519|NCT02194998|BG003|Baseline|Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for participants with HCV genotype 1a only; participants with HCV genotype 1b did not receive RBV).
11200520|NCT02194998|BG004|Baseline|Total|Total of all reporting groups
11200521|NCT02194998|FG000|Participant Flow|Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200522|NCT02194998|FG001|Participant Flow|Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200523|NCT02194998|FG002|Participant Flow|Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200524|NCT02194998|FG003|Participant Flow|Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200525|NCT02194998|OG000|Outcome|Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200526|NCT02194998|OG001|Outcome|Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200527|NCT02194998|OG002|Outcome|Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200528|NCT02194998|OG003|Outcome|Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200529|NCT02194998|EG000|Reported Event|Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200530|NCT02194998|EG001|Reported Event|Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200531|NCT02194998|EG002|Reported Event|Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200532|NCT02194998|EG003|Reported Event|Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]|Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
11200533|NCT02195011|BG000|Baseline|Cohort 1: Regorafenib/SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.~Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200534|NCT02195011|BG001|Baseline|Cohort 2: SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.~Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200535|NCT02195011|BG002|Baseline|Total|Total of all reporting groups
11200536|NCT02195011|FG000|Participant Flow|Cohort 1: Regorafenib/SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.~Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200537|NCT02195011|FG001|Participant Flow|Cohort 2: SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.~Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200538|NCT02195011|OG000|Outcome|Cohort 1: Regorafenib/SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.~Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200539|NCT02195011|OG001|Outcome|Cohort 2: SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.~Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
10850332|NCT00302042|EG001|Reported Event|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
10804026|NCT04422990|FG001|Participant Flow|LID018869|Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
11242567|NCT02496767|EG003|Reported Event|Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11200540|NCT02195011|EG000|Reported Event|Cohort 1: Regorafenib/SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.~Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
10800326|NCT02007512|FG003|Participant Flow|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800327|NCT02007512|OG000|Outcome|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800328|NCT02007512|OG001|Outcome|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800329|NCT02007512|OG002|Outcome|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800330|NCT02007512|OG003|Outcome|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11200541|NCT02195011|EG001|Reported Event|Cohort 2: SIR-Spheres/Regorafenib|"Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.~Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle"
11200542|NCT02195232|BG000|Baseline|Cohort A (Isoquercetin 500 mg)|Patients will receive isoquercetin 500 mg once daily (2 capsules).
11200543|NCT02195232|BG001|Baseline|Cohort B (Isoquercetin 1000 mg)|Patients will receive isoquercetin 1000 mg once daily (4 capsules).
11200544|NCT02195232|BG002|Baseline|Total|Total of all reporting groups
11200545|NCT02195232|FG000|Participant Flow|Cohort A (Isoquercetin 500 mg)|Patients will receive isoquercetin 500 mg once daily (2 capsules).
11200546|NCT02195232|FG001|Participant Flow|Cohort B (Isoquercetin 1000 mg)|Patients will receive isoquercetin 1000 mg once daily (4 capsules).
11200547|NCT02195232|OG000|Outcome|Cohort A (Isoquercetin 500 mg)|Patients will receive isoquercetin 500 mg once daily (2 capsules).
11200548|NCT02195232|OG001|Outcome|Cohort B (Isoquercetin 1000 mg)|Patients will receive isoquercetin 1000 mg once daily (4 capsules).
11200549|NCT02195232|OG000|Outcome|Cohort A (Isoquercetin 500 mg)|"Cohort A: Patients will receive isoquercetin 500 mg once daily (2 capsules) for 28 days.~Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days."
11200550|NCT02195232|OG001|Outcome|Cohort B (Isoquercetin 1000 mg)|"Cohort B: Patients will receive isoquercetin 1000 mg once daily (4 capsules) for 28 days.~Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days."
11200551|NCT02195232|OG000|Outcome|Cohort A - Isoquercetin|"-- Cohort A: 500 mg, Once daily, 28 days~- For both cohorts A and B, lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days.~Isoquercetin"
11200552|NCT02195232|OG001|Outcome|Cohort B - Isoquercetin|"--Cohort B: 1000 mg, Once daily, 28 days~- For both cohorts A and B, lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days.~Isoquercetin"
11200553|NCT02195232|EG000|Reported Event|Cohort A (Isoquercetin 500 mg)|"Cohort A: Patients will receive isoquercetin 500 mg once daily (2 capsules) for 28 days.~Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days."
11200554|NCT02195232|EG001|Reported Event|Cohort B (Isoquercetin 1000 mg)|"Cohort B: Patients will receive isoquercetin 1000 mg once daily (4 capsules) for 28 days.~Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days."
11200555|NCT02195310|BG000|Baseline|Prevena™ Incision Management System|"Subjects will receive sternal wound treatment in the operating room with Prevena™ IMS according to the intended use~Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision"
11200556|NCT02195310|BG001|Baseline|Conventional Sterile Wound Dressings|"Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze)~Conventional sterile wound dressings are placed after sternotomy on the closed incision"
11200557|NCT02195310|BG002|Baseline|Total|Total of all reporting groups
10850333|NCT00302055|BG000|Baseline|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
10804027|NCT04422990|OG000|Outcome|Biofinity|Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
11200558|NCT02195310|FG000|Participant Flow|Prevena™ Incision Management System|"Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use~Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision"
10800331|NCT02007512|OG000|Outcome|Enzalutamide 160 mg|Participants received enzalutamide 160 mg dose orally, once daily, either in double blind treatment period or in open label treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after the last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800332|NCT02007512|OG000|Outcome|Exemestane 25 mg|Participants received exemestane 25 mg dose orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after the last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800333|NCT02007512|OG001|Outcome|Exemestane 50 mg|Participants received exemestane 50 mg dose orally, once daily until disease progression or permanent treatment discontinuation, either in double blind treatment period or in open label treatment period. Participants were followed-up until 30 days after the last dose of study drug, the date of death, or before initiation of a new antitumor treatment, whichever occurred first.
10804028|NCT04422990|OG001|Outcome|LID018869|Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
10804029|NCT04422990|EG000|Reported Event|Pre-Treatment|Events reported in this group occurred prior to exposure to the study contact lenses
10804030|NCT04422990|EG001|Reported Event|Biofinity Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11200559|NCT02195310|FG001|Participant Flow|Conventional Sterile Wound Dressings|"Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).~Conventional sterile wound dressings are placed after sternotomy on the closed incision"
11200560|NCT02195310|OG000|Outcome|Prevena™ Incision Management System|"Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use~Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision"
11200561|NCT02195310|OG001|Outcome|Conventional Sterile Wound Dressings|"Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).~Conventional sterile wound dressings are placed after sternotomy on the closed incision"
11200562|NCT02195310|EG000|Reported Event|Prevena™ Incision Management System|"Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use~Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision"
11200563|NCT02195310|EG001|Reported Event|Conventional Sterile Wound Dressings|"Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).~Conventional sterile wound dressings: Conventional sterile wound dressings are placed after sternotomy on the closed incision"
11200564|NCT02195349|BG000|Baseline|Placebo for Healthy Volunteer Combined|Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200565|NCT02195349|BG001|Baseline|GSK2831781 0.0003 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
10804031|NCT04422990|EG002|Reported Event|Biofinity Non-Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
10804032|NCT04422990|EG003|Reported Event|LID018869 Ocular|Events reported in this group occurred while exposed to LID018869 contact lenses
10804033|NCT04422990|EG004|Reported Event|LID018869 Non-Ocular|Events reported in this group occurred while exposed to LID018869 contact lenses
10804034|NCT04388319|BG000|Baseline|Combination Zonisamide and Bupropion With E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.~Zonisamide: Zonisamide (100 mg/daily) for 12 weeks.~Bupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.~Halo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."
10804035|NCT04388319|FG000|Participant Flow|Combination Zonisamide and Bupropion With E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.~Zonisamide: Zonisamide (100 mg/daily) for 12 weeks.~Bupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.~Halo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."
10850334|NCT00302055|BG001|Baseline|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
10850335|NCT00302055|BG002|Baseline|Total|Total of all reporting groups
10850336|NCT00302055|FG000|Participant Flow|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
10800334|NCT02007512|EG000|Reported Event|Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg|Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11200566|NCT02195349|BG002|Baseline|GSK2831781 0.0015 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200567|NCT02195349|BG003|Baseline|GSK2831781 0.0075 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200568|NCT02195349|BG004|Baseline|GSK2831781 0.04 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200569|NCT02195349|BG005|Baseline|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200570|NCT02195349|BG006|Baseline|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200571|NCT02195349|BG007|Baseline|Placebo for Psoriasis|Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200572|NCT02195349|BG008|Baseline|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200573|NCT02195349|BG009|Baseline|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200574|NCT02195349|BG010|Baseline|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200575|NCT02195349|BG011|Baseline|Total|Total of all reporting groups
11200576|NCT02195349|FG000|Participant Flow|Placebo for Healthy Volunteer Combined|Healthy volunteers with no delayed type hypersensitivity (DTH) and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200577|NCT02195349|FG001|Participant Flow|GSK2831781 0.0003 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing anti-drug antibodies negative (ADA-ve) status received a single dose of GSK2831781 0.0003 milligram per kilogram (mg/kg) saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200578|NCT02195349|FG002|Participant Flow|GSK2831781 0.0015 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200579|NCT02195349|FG003|Participant Flow|GSK2831781 0.0075 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200580|NCT02195349|FG004|Participant Flow|GSK2831781 0.04 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200581|NCT02195349|FG005|Participant Flow|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 milliliter (mL) of 2 tuberculin unit (TU) or 10 TU purified protein derivative (PPD) (0.04 microgram [mcg]/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200582|NCT02195349|FG006|Participant Flow|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200583|NCT02195349|FG007|Participant Flow|Placebo for Psoriasis|Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200584|NCT02195349|FG008|Participant Flow|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200585|NCT02195349|FG009|Participant Flow|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200586|NCT02195349|FG010|Participant Flow|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200587|NCT02195349|OG000|Outcome|Placebo for Healthy Volunteer Combined|Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200588|NCT02195349|OG001|Outcome|GSK2831781 0.0003 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200589|NCT02195349|OG002|Outcome|GSK2831781 0.0015 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200590|NCT02195349|OG003|Outcome|GSK2831781 0.0075 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
10850337|NCT00302055|FG001|Participant Flow|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
11200591|NCT02195349|OG004|Outcome|GSK2831781 0.04 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200592|NCT02195349|OG005|Outcome|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200593|NCT02195349|OG006|Outcome|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200594|NCT02195349|OG007|Outcome|Placebo for Psoriasis|Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200595|NCT02195349|OG008|Outcome|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200596|NCT02195349|OG009|Outcome|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200597|NCT02195349|OG010|Outcome|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200598|NCT02195349|OG000|Outcome|GSK2831781 0.0003 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200599|NCT02195349|OG000|Outcome|GSK2831781 0.0015 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200600|NCT02195349|OG000|Outcome|GSK2831781 0.0075 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
10849968|NCT00299494|BG003|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11200601|NCT02195349|OG000|Outcome|GSK2831781 0.04 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200602|NCT02195349|OG000|Outcome|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200603|NCT02195349|OG000|Outcome|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200604|NCT02195349|OG000|Outcome|Placebo for Psoriasis|Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200605|NCT02195349|OG000|Outcome|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200606|NCT02195349|OG000|Outcome|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200607|NCT02195349|OG000|Outcome|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200608|NCT02195349|OG000|Outcome|Placebo for Healthy Volunteer|Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200609|NCT02195349|OG001|Outcome|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200610|NCT02195349|OG001|Outcome|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200611|NCT02195349|OG002|Outcome|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200612|NCT02195349|OG003|Outcome|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200613|NCT02195349|OG001|Outcome|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200614|NCT02195349|EG000|Reported Event|Placebo for Healthy Volunteer Combined|Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200615|NCT02195349|EG001|Reported Event|GSK2831781 0.0003 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200616|NCT02195349|EG002|Reported Event|GSK2831781 0.0015 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200617|NCT02195349|EG003|Reported Event|GSK2831781 0.0075 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200618|NCT02195349|EG004|Reported Event|GSK2831781 0.04 mg/kg (ADA-ve)|Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200619|NCT02195349|EG005|Reported Event|GSK2831781 0.15 mg/kg (ADA-ve)|Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
11200620|NCT02195349|EG006|Reported Event|GSK2831781 0.15 mg/kg (ADA+ve)|Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200621|NCT02195349|EG007|Reported Event|Placebo for Psoriasis|Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
11200622|NCT02195349|EG008|Reported Event|GSK2831781 0.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200623|NCT02195349|EG009|Reported Event|GSK2831781 1.5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200624|NCT02195349|EG010|Reported Event|GSK2831781 5 mg/kg|Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
11200625|NCT02195414|BG000|Baseline|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
11200626|NCT02195414|FG000|Participant Flow|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
11200627|NCT02195414|OG000|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
11200628|NCT02195414|EG000|Reported Event|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
10966207|NCT00886236|OG001|Outcome|2 Preoperative and Postoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
11200629|NCT02195427|BG000|Baseline|TEOSYAL RHA Global Action/Juvederm Ultra XC|Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
10966208|NCT00886236|OG002|Outcome|3 Preoperative and Postoperative Placebo Liquid|"Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966209|NCT00886236|EG000|Reported Event|1 Preoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966210|NCT00886236|EG001|Reported Event|2 Preoperative and Postoperative Gabapentin Liquid|"Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)~Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966211|NCT00886236|EG002|Reported Event|3 Preoperative and Postoperative Placebo Liquid|"Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)~Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)"
10966212|NCT00886262|BG000|Baseline|Vasopressin|Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
10966213|NCT00886262|BG001|Baseline|Normal Saline Placebo|Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
10966214|NCT00886262|BG002|Baseline|Total|Total of all reporting groups
11200630|NCT02195427|BG001|Baseline|TEOSYAL RHA Deep Lines/Juvederm Ultra XC|Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
11200631|NCT02195427|BG002|Baseline|Total|Total of all reporting groups
10850338|NCT00302055|OG000|Outcome|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
11200632|NCT02195427|FG000|Participant Flow|TEOSYAL RHA Global Action/Juvederm Ultra XC|"Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Global Action: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2 disposable sterile needles."
11200633|NCT02195427|FG001|Participant Flow|TEOSYAL RHA Deep Lines/Juvederm Ultra XC|"Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Deep Lines: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2 disposable sterile needles."
11200634|NCT02195427|OG000|Outcome|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
11200635|NCT02195427|OG001|Outcome|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
11200636|NCT02195427|OG002|Outcome|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
11200637|NCT02195427|OG003|Outcome|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
11200638|NCT02195427|EG000|Reported Event|TEOSYAL® RHA Global Action|Injection of TEOSYAL® RHA Global Action into one NLF
11200639|NCT02195427|EG001|Reported Event|Juvéderm® Ultra XC (RHA GA)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Global Action
11200640|NCT02195427|EG002|Reported Event|TEOSYAL® RHA Deep Lines|Injection of TEOSYAL® RHA Deep Lines into one NLF
11200641|NCT02195427|EG003|Reported Event|Juvéderm® Ultra XC (RHA DL)|Injection of Juvéderm® Ultra XC into the contralateral NLF of the one injected with TEOSYAL® RHA Deep Lines
11200642|NCT02195518|BG000|Baseline|Tenofovir Disoproxil Fumerate 300 mg|Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
11200643|NCT02195518|FG000|Participant Flow|Tenofovir Disoproxil Fumerate 300 mg|Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
11200644|NCT02195518|OG000|Outcome|Tenofovir Disoproxil Fumerate 300 mg|Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
11200645|NCT02195518|EG000|Reported Event|Tenofovir Disoproxil Fumerate 300 mg|Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.
11200646|NCT02195531|BG000|Baseline|Standard of Care|Participants will not receive education or feedback.
11200647|NCT02195531|BG001|Baseline|Treatment|"Participants will receive education and feedback tailored to the psychological profile of the receiving participant.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200648|NCT02195531|BG002|Baseline|Control Group|"Participants will receive education inconsistent with their profile.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200649|NCT02195531|BG003|Baseline|Total|Total of all reporting groups
11200650|NCT02195531|FG000|Participant Flow|Standard of Care|Participants will not receive education or feedback.
11200651|NCT02195531|FG001|Participant Flow|Treatment Group|"Participants will receive education and feedback tailored to the psychological profile of the receiving participant.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200652|NCT02195531|FG002|Participant Flow|Control Group|"Participants will receive education inconsistent with their profile.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200653|NCT02195531|OG000|Outcome|Treatment|"Participants will receive education and feedback tailored to the psychological profile of the receiving participant.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
10850339|NCT00302055|OG001|Outcome|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
10850340|NCT00302055|EG000|Reported Event|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
11200654|NCT02195531|OG001|Outcome|Control Group|"Participants will receive education inconsistent with their profile.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200655|NCT02195531|OG002|Outcome|Standard of Care|Participants will not receive education or feedback.
11200656|NCT02195531|EG000|Reported Event|Treatment|"Participants will receive education and feedback tailored to the psychological profile of the receiving participant.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200657|NCT02195531|EG001|Reported Event|Control Group|"Participants will receive education inconsistent with their profile.~Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns."
11200658|NCT02195531|EG002|Reported Event|Standard of Care|Participants will not receive education or feedback.
11200659|NCT02195583|BG000|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
11202349|NCT02207244|FG008|Participant Flow|Adalimumab Then Guselkumab 100 mg (Week 28 - 264)|Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
10850341|NCT00302055|EG001|Reported Event|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
10966215|NCT00886262|FG000|Participant Flow|Vasopressin|Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
10966216|NCT00886262|FG001|Participant Flow|Normal Saline Placebo|Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
10966217|NCT00886262|OG000|Outcome|Vasopressin|Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
10966218|NCT00886262|OG001|Outcome|Normal Saline Placebo|Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
10966219|NCT00886262|EG000|Reported Event|Vasopressin|Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
10966220|NCT00886262|EG001|Reported Event|Normal Saline Placebo|Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
10966221|NCT00886288|BG000|Baseline|Patients Without Albuminuria Treated With Telmisartan|baseline population
10966222|NCT00886288|BG001|Baseline|Patients With Albuminuria Treated With Telmisartan|baseline population
10966223|NCT00886288|BG002|Baseline|Total|Total of all reporting groups
10966224|NCT00886288|FG000|Participant Flow|Patients Without Albuminuria Treated With Telmisartan|
10966225|NCT00886288|FG001|Participant Flow|Patients With Albuminuria Treated With Telmisartan|
10966226|NCT00886288|OG000|Outcome|Patients Without Albuminuria Treated With Telmisartan|
10966227|NCT00886288|OG001|Outcome|Patients With Albuminuria Treated With Telmisartan|
10966228|NCT00886288|OG000|Outcome|Patients With Albuminuria Treated With Telmisartan|
10966229|NCT00886288|EG000|Reported Event|Patients Without Albuminuria Treated With Telmisartan|
10966230|NCT00886288|EG001|Reported Event|Patients With Albuminuria Treated With Telmisartan|
10966231|NCT00886288|EG002|Reported Event||patients without baseline albuminuria data
10966232|NCT00886340|BG000|Baseline|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
10966233|NCT00886340|BG001|Baseline|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
10966234|NCT00886340|BG002|Baseline|Total|Total of all reporting groups
11202350|NCT02207244|FG009|Participant Flow|Adalimumab (After ACP)|Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of >=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
10966235|NCT00886340|FG000|Participant Flow|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
10966236|NCT00886340|FG001|Participant Flow|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
10966237|NCT00886340|OG000|Outcome|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
10966238|NCT00886340|OG001|Outcome|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
10966239|NCT00886340|EG000|Reported Event|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
10966240|NCT00886340|EG001|Reported Event|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
10966241|NCT00886379|BG000|Baseline|Unfortified Mongolain Milk|Mongolian milk without vitamin D: 710ml per day for 49 days
10966242|NCT00886379|BG001|Baseline|Fortified Mongolian Milk|Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966243|NCT00886379|BG002|Baseline|Fortified UHT Milk|UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966244|NCT00886379|BG003|Baseline|Daily Vitamin D Supplements|Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
10966245|NCT00886379|BG004|Baseline|Seasonal Vitamin D Supplements|Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
10966246|NCT00886379|BG005|Baseline|Total|Total of all reporting groups
10966247|NCT00886379|FG000|Participant Flow|Unfortified Mongolian Milk|Mongolian milk without vitamin D: 710ml per day for 49 days
10966248|NCT00886379|FG001|Participant Flow|Fortified Mongolian Milk|Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966249|NCT00886379|FG002|Participant Flow|Fortified UHT Milk|UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966250|NCT00886379|FG003|Participant Flow|Daily Vitamin D Supplements|Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
10966251|NCT00886379|FG004|Participant Flow|Seasonal Vitamin D Supplements|Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
11200660|NCT02195583|FG000|Participant Flow|Overall Participants|"Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.~Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base~Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base"
11200661|NCT02195583|OG000|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200662|NCT02195583|OG001|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11202351|NCT02207244|FG010|Participant Flow|Guselkumab Combined|All participants who received guselkumab 100 mg subcutaneously q8w at Week 76 and thereafter through Week 252.
11242568|NCT02496767|EG004|Reported Event|Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv|Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
11200663|NCT02195583|OG002|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200664|NCT02195583|OG003|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
10850342|NCT00302068|BG000|Baseline|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
10800335|NCT02007512|EG001|Reported Event|Cohort 1: Placebo + Exemestane 25 mg|Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
11200665|NCT02195583|OG004|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200666|NCT02195583|OG005|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200667|NCT02195583|OG005|Outcome|Sodium Fluoride (0 Ppm)|Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200668|NCT02195583|EG000|Reported Event|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200669|NCT02195583|EG001|Reported Event|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200670|NCT02195583|EG002|Reported Event|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11202352|NCT02207244|OG000|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
10850343|NCT00302068|BG001|Baseline|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
10966252|NCT00886379|OG000|Outcome|Unfortified Mongolain Milk|Mongolian milk without vitamin D: 710ml per day for 49 days
10966253|NCT00886379|OG001|Outcome|Fortified Mongolian Milk|Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966254|NCT00886379|OG002|Outcome|Fortified UHT Milk|UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966255|NCT00886379|OG003|Outcome|Daily Vitamin D Supplements|Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
10966256|NCT00886379|OG004|Outcome|Seasonal Vitamin D Supplements|Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
10966257|NCT00886379|EG000|Reported Event|Unfortified Mongolain Milk|Mongolian milk without vitamin D: 710ml per day for 49 days
10966258|NCT00886379|EG001|Reported Event|Fortified Mongolian Milk|Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966259|NCT00886379|EG002|Reported Event|Fortified UHT Milk|UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
10966260|NCT00886379|EG003|Reported Event|Daily Vitamin D Supplements|Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
10966261|NCT00886379|EG004|Reported Event|Seasonal Vitamin D Supplements|Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
10850344|NCT00302068|BG002|Baseline|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
10850345|NCT00302068|BG003|Baseline|Total|Total of all reporting groups
11242569|NCT02496767|EG005|Reported Event|Double-blind, Withdrawal: Placebo|Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.
11242570|NCT02496767|EG006|Reported Event|Double-blind, Withdrawal: Tirasemtiv to Placebo|Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.
10966262|NCT00886483|BG000|Baseline|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
11242571|NCT02496767|EG007|Reported Event|Double-blind, Withdrawal: Tirasemtiv|Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
11242572|NCT02496884|BG000|Baseline|M-CKD Placebo|Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
11242573|NCT02496884|BG001|Baseline|M-CKD DS-5565 7.5 mg BID|Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
11242574|NCT02496884|BG002|Baseline|S-CKD Placebo|Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
10800336|NCT02007512|EG002|Reported Event|Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10800337|NCT02007512|EG003|Reported Event|Cohort 2: Placebo + Exemestane 25 mg|Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
10850346|NCT00302068|FG000|Participant Flow|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
11200671|NCT02195583|EG003|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200672|NCT02195583|EG004|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200673|NCT02195583|EG005|Reported Event|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
11200674|NCT02195622|BG000|Baseline|Lumenis VersaCut Morcellator|"Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation~Lumenis VersaCut Morcellator"
11200675|NCT02195622|BG001|Baseline|Wolf Piranha Morcellator|"Wolf Piranha Morcellator will be utilized for prostate tissue morcellation~Wolf Piranha Morcellator"
11200676|NCT02195622|BG002|Baseline|Total|Total of all reporting groups
11200677|NCT02195622|FG000|Participant Flow|Lumenis VersaCut Morcellator|"Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation~Lumenis VersaCut Morcellator"
11200678|NCT02195622|FG001|Participant Flow|Wolf Piranha Morcellator|"Wolf Piranha Morcellator will be utilized for prostate tissue morcellation~Wolf Piranha Morcellator"
11200679|NCT02195622|OG000|Outcome|Lumenis VersaCut Morcellator|"Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation~Lumenis VersaCut Morcellator"
11200680|NCT02195622|OG001|Outcome|Wolf Piranha Morcellator|"Wolf Piranha Morcellator will be utilized for prostate tissue morcellation~Wolf Piranha Morcellator"
11200681|NCT02195622|EG000|Reported Event|Wolf Piranha Morcellator|
11200682|NCT02195622|EG001|Reported Event|Lumenis VersaCut Morcellator|
11200683|NCT02195687|BG000|Baseline|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11200684|NCT02195687|BG001|Baseline|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
11200685|NCT02195687|BG002|Baseline|Total|Total of all reporting groups
11200686|NCT02195687|FG000|Participant Flow|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11200687|NCT02195687|FG001|Participant Flow|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
11200688|NCT02195687|OG000|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11200689|NCT02195687|OG001|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
11200690|NCT02195687|EG000|Reported Event|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
11200691|NCT02195687|EG001|Reported Event|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
11242575|NCT02496884|BG003|Baseline|S-CKD DS-5565 7.5 mg QD|Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
10850347|NCT00302068|FG001|Participant Flow|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
11200692|NCT02195700|BG000|Baseline|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
11200693|NCT02195700|BG001|Baseline|Placebo|"Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
11200694|NCT02195700|BG002|Baseline|Total|Total of all reporting groups
11200695|NCT02195700|FG000|Participant Flow|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
11200696|NCT02195700|FG001|Participant Flow|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
11202353|NCT02207244|OG001|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
11200697|NCT02195700|OG000|Outcome|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
11200698|NCT02195700|OG001|Outcome|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
11200699|NCT02195700|EG000|Reported Event|SD-809|"Patients underwent dose adjustment of SD-809 over the initial 6 weeks of treatment, starting treatment with SD-809 at 6 mg twice daily and titrating to a maximum total daily dose of 48 mg per day. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout.~Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment."
11200700|NCT02195700|EG001|Reported Event|Placebo|Patients underwent 'dose adjustment' of placebo over the initial 6 weeks of treatment. The optimal dose was continued by a 6-week maintenance period, which was followed by a 1-week washout. Patients who completed the study had the option to rollover into a long-term safety study (Study SD-809-C-20, NCT02198794). For patients who did not enter the long-term safety study, there was an additional 3-week safety follow-up period after treatment.
11200701|NCT02195713|BG000|Baseline|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
11200702|NCT02195713|BG001|Baseline|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
11200703|NCT02195713|BG002|Baseline|Total|Total of all reporting groups
11200704|NCT02195713|FG000|Participant Flow|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
11200705|NCT02195713|FG001|Participant Flow|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
11200706|NCT02195713|OG000|Outcome|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
11200707|NCT02195713|OG001|Outcome|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
11200708|NCT02195713|EG000|Reported Event|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
11200709|NCT02195713|EG001|Reported Event|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
11200710|NCT02195869|BG000|Baseline|Phase 1b/Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200711|NCT02195869|FG000|Participant Flow|Phase 1b/Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200712|NCT02195869|OG000|Outcome|Phase 1b: Dose Level 1|Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1
11200713|NCT02195869|OG001|Outcome|Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200714|NCT02195869|OG000|Outcome|Phase1b/Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200715|NCT02195869|OG000|Outcome|Phase 1b/Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200716|NCT02195869|EG000|Reported Event|Phase1b/Phase 2|Subjects receive daily dose of 420 mg of Ibrutinib capsules
11200717|NCT02195895|BG000|Baseline|Alendronate, Calcium, Vitamin D|"Drug: Weekly oral alendronate 70 mg for 12 months~Supplements: Calcium and Vitamin D daily for 12 months~Alendronate: Weekly oral alendronate 70 mg for 12 months~Calcium: Daily Oral 1000 mg~Vitamin D: Daily Oral 1000 IU"
11200718|NCT02195895|FG000|Participant Flow|Alendronate, Calcium, Vitamin D|"Drug: Weekly oral alendronate 70 mg for 12 months~Supplements: Calcium and Vitamin D daily for 12 months~Alendronate: Weekly oral alendronate 70 mg for 12 months~Calcium: Daily Oral 1000 mg~Vitamin D: Daily Oral 1000 IU"
11200719|NCT02195895|OG000|Outcome|Alendronate, Calcium, Vitamin D|"Drug: Weekly oral alendronate 70 mg for 12 months~Supplements: Calcium and Vitamin D daily for 12 months~Alendronate: Weekly oral alendronate 70 mg for 12 months~Calcium: Daily Oral 1000 mg~Vitamin D: Daily Oral 1000 IU"
11200720|NCT02195895|EG000|Reported Event|Alendronate, Calcium, Vitamin D|"Drug: Weekly oral alendronate 70 mg for 12 months~Supplements: Calcium and Vitamin D daily for 12 months~Alendronate: Weekly oral alendronate 70 mg for 12 months~Calcium: Daily Oral 1000 mg~Vitamin D: Daily Oral 1000 IU"
11200721|NCT02195921|BG000|Baseline|Single Point CV12|"choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a de Qi sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Neiguan(CV12) plus antiemetic drug"
11242576|NCT02496884|BG004|Baseline|Total|Total of all reporting groups
11242577|NCT02496884|FG000|Participant Flow|M-CKD Placebo|Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
11200722|NCT02195921|BG001|Baseline|Single Point ST36|"choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Zusanli(ST36) plus antiemetic drug"
11200723|NCT02195921|BG002|Baseline|Matching Points ST36+CV12|"Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug"
11200724|NCT02195921|BG003|Baseline|Only Antiemetics|"The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.~only antiemetic drug"
11200725|NCT02195921|BG004|Baseline|Total|Total of all reporting groups
11200726|NCT02195921|FG000|Participant Flow|Single Point CV12|"choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a de Qi sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Neiguan(CV12) plus antiemetic drug"
11200727|NCT02195921|FG001|Participant Flow|Single Point ST36|"choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Zusanli(ST36) plus antiemetic drug"
11200728|NCT02195921|FG002|Participant Flow|Matching Points ST36+CV12|"Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug"
11200729|NCT02195921|FG003|Participant Flow|Only Antiemetics|"The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.~only antiemetic drug"
11200730|NCT02195921|OG000|Outcome|Single Point CV12|"choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a de Qi sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Neiguan(CV12) plus antiemetic drug"
11200731|NCT02195921|OG001|Outcome|Single Point ST36|"choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Zusanli(ST36) plus antiemetic drug"
11202354|NCT02207244|OG000|Outcome|Placebo|Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
11242578|NCT02496884|FG001|Participant Flow|M-CKD DS-5565 7.5 mg BID|Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
11200732|NCT02195921|OG002|Outcome|ST36+CV12|"Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug"
11200733|NCT02195921|OG003|Outcome|Only Antiemetics|"The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.~only antiemetic drug"
11200734|NCT02195921|OG000|Outcome|CV12|Stimulated CV12
11200735|NCT02195921|OG001|Outcome|ST36|Stimulated ST36
11200736|NCT02195921|OG002|Outcome|CV12+ST36|Stimulated CV12+ST36
11200737|NCT02195921|OG003|Outcome|Control|Antiemetic only
11242579|NCT02496884|FG002|Participant Flow|S-CKD Placebo|Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
11242580|NCT02496884|FG003|Participant Flow|S-CKD DS-5565 7.5 mg QD|Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
11242581|NCT02496884|OG000|Outcome|M-CKD Placebo|Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
10850348|NCT00302068|FG002|Participant Flow|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
11242582|NCT02496884|OG001|Outcome|M-CKD DS-5565 7.5 mg BID|Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
11242583|NCT02496884|OG002|Outcome|S-CKD Placebo|Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
11200738|NCT02195921|OG002|Outcome|Matching Points ST36+CV12|"Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug"
11200739|NCT02195921|EG000|Reported Event|Single Point CV12|"choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a de Qi sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Neiguan(CV12) plus antiemetic drug"
11200740|NCT02195921|EG001|Reported Event|Single Point ST36|"choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~single point Zusanli(ST36) plus antiemetic drug"
11200741|NCT02195921|EG002|Reported Event|ST36+CV12|"Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.~matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug"
11200742|NCT02195921|EG003|Reported Event|Only Antiemetics|"The control group will receive standard antiemetics alone. Standard antiemetics for all groups are based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron , Tropisetron)and dexamethasone are supplied from the first day of chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.~only antiemetic drug"
11200743|NCT02196038|BG000|Baseline|Attention Control|Usual care group with bi-weekly contact
11200744|NCT02196038|BG001|Baseline|Rehabilitation Intervention|Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
11200745|NCT02196038|BG002|Baseline|Total|Total of all reporting groups
11200746|NCT02196038|FG000|Participant Flow|Attention Control|Usual care group with bi-weekly contact
11200747|NCT02196038|FG001|Participant Flow|Rehabilitation Intervention|Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
11200748|NCT02196038|OG000|Outcome|Attention Control|Usual care group with bi-weekly contact
11200749|NCT02196038|OG001|Outcome|Rehabilitation Intervention|Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
11200750|NCT02196038|EG000|Reported Event|Attention Control|Usual care group with bi-weekly contact
11200751|NCT02196038|EG001|Reported Event|Rehabilitation Intervention|Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
11200752|NCT02196077|BG000|Baseline|Subjects|
11200753|NCT02196077|FG000|Participant Flow|Subjects|
11200754|NCT02196077|OG000|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
11200755|NCT02196077|OG001|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
11200756|NCT02196077|OG002|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
11200757|NCT02196077|OG003|Outcome|BD MDI 320 ug|BD MDI 320 ug
11200758|NCT02196077|OG004|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
11200759|NCT02196077|EG000|Reported Event|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
11200760|NCT02196077|EG001|Reported Event|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
11200761|NCT02196077|EG002|Reported Event|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
11200762|NCT02196077|EG003|Reported Event|BD MDI 320 ug|BD MDI 320 ug
11200763|NCT02196077|EG004|Reported Event|FF MDI 9.6 ug|FF MDI 9.6 ug
11200764|NCT02196168|BG000|Baseline|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
11200765|NCT02196168|BG001|Baseline|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11200766|NCT02196168|BG002|Baseline|Total|Total of all reporting groups
11200767|NCT02196168|FG000|Participant Flow|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
11242584|NCT02496884|OG003|Outcome|S-CKD DS-5565 7.5 mg QD|Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
11200768|NCT02196168|FG001|Participant Flow|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11200769|NCT02196168|OG000|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
11200770|NCT02196168|OG001|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11200771|NCT02196168|EG000|Reported Event|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
11200772|NCT02196168|EG001|Reported Event|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
11200773|NCT02196259|BG000|Baseline|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200774|NCT02196259|BG001|Baseline|Initial Hospital|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
11200775|NCT02196259|BG002|Baseline|Depression|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
11200776|NCT02196259|BG003|Baseline|Total|Total of all reporting groups
11200777|NCT02196259|FG000|Participant Flow|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200778|NCT02196259|FG001|Participant Flow|Hospital|
11200779|NCT02196259|FG002|Participant Flow|Depresssion|
11200780|NCT02196259|OG000|Outcome|Initial MRI|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
11200781|NCT02196259|OG001|Outcome|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200782|NCT02196259|EG000|Reported Event|Initial fMRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200783|NCT02196259|EG001|Reported Event|Hospital|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200784|NCT02196259|EG002|Reported Event|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
11200785|NCT02196324|BG000|Baseline|Placebo|Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11200786|NCT02196324|BG001|Baseline|Serlopitant|Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11200787|NCT02196324|BG002|Baseline|Total|Total of all reporting groups
11200788|NCT02196324|FG000|Participant Flow|Placebo|Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11200789|NCT02196324|FG001|Participant Flow|Serlopitant|Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11242585|NCT02496884|EG000|Reported Event|M-CKD Placebo|Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
11200790|NCT02196324|OG000|Outcome|Placebo|Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11200791|NCT02196324|OG001|Outcome|Serlopitant|Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
10800338|NCT01999179|BG000|Baseline|Low-molecular-weight Heparin or Direct Oral Anticoagulant|"Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.~Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.~Heparin, Low-Molecular-Weight, or direct oral anticoagulants: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot"
10850349|NCT00302068|OG000|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
11200792|NCT02196324|EG000|Reported Event|Placebo|Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11242586|NCT02496884|EG001|Reported Event|M-CKD DS-5565 7.5 mg BID|Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
11242587|NCT02496884|EG002|Reported Event|S-CKD Placebo|Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
11242588|NCT02496884|EG003|Reported Event|S-CKD DS-5565 7.5 mg QD|Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
11242589|NCT02497001|BG000|Baseline|BGF MDI 320/14.4/9.6 ug|Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug
11242590|NCT02497001|BG001|Baseline|GFF MDI 14.4/9.6 ug|Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug
11242591|NCT02497001|BG002|Baseline|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 ug
11242592|NCT02497001|BG003|Baseline|Symbicort TBH 400/12 ug|Symbicort Turbuhaler 400/12 ug
11242593|NCT02497001|BG004|Baseline|Total|Total of all reporting groups
11242594|NCT02497001|FG000|Participant Flow|BGF MDI 320/14.4/9.6 ug|Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug
11242595|NCT02497001|FG001|Participant Flow|GFF MDI 14.4/9.6 ug|Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug
11242596|NCT02497001|FG002|Participant Flow|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 ug
11242597|NCT02497001|FG003|Participant Flow|Symbicort TBH 400/12 ug|Symbicort Turbuhaler 400/12 ug
11242598|NCT02497001|OG000|Outcome|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
11242599|NCT02497001|OG001|Outcome|GFF MDI (PT003) 14.4/9.6 μg|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
11242600|NCT02497001|OG002|Outcome|BFF MDI (PT009) 320/9.6 μg|Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
11242601|NCT02497001|OG003|Outcome|Symbicort®|Symbicort® Turbuhaler® (TBH) Inhalation Powder
11242602|NCT02497001|OG000|Outcome|GFF MDI (PT003) 14.4/9.6 μg|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
11242603|NCT02497001|OG001|Outcome|BFF MDI (PT009) 320/9.6 μg|Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
11242604|NCT02497001|OG002|Outcome|Symbicort®|Symbicort® Turbuhaler® (TBH) Inhalation Powder
11242605|NCT02497001|EG000|Reported Event|BGF MDI 320/14.4/9.6 ug|Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug
11242606|NCT02497001|EG001|Reported Event|GFF MDI 14.4/9.6 ug|Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug
11242607|NCT02497001|EG002|Reported Event|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 ug
11242608|NCT02497001|EG003|Reported Event|Symbicort TBH 400/12 ug|Symbicort Turbuhaler 400/12 ug
11242609|NCT02497040|BG000|Baseline|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
11242610|NCT02497040|BG001|Baseline|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
11242611|NCT02497040|BG002|Baseline|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
11242612|NCT02497040|BG003|Baseline|Total|Total of all reporting groups
11242613|NCT02497040|FG000|Participant Flow|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
11242614|NCT02497040|FG001|Participant Flow|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
11242615|NCT02497040|FG002|Participant Flow|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
11242616|NCT02497040|OG000|Outcome|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
11242617|NCT02497040|OG001|Outcome|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
11242618|NCT02497040|OG002|Outcome|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
11242619|NCT02497040|EG000|Reported Event|Bupivacaine,Levobupivacaine|"20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine~Levobupivacaine: local injection~Bupivacaine: local injection"
11242620|NCT02497040|EG001|Reported Event|Levobupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Levobupivacaine: local injection~placebo: local injection"
11242621|NCT02497040|EG002|Reported Event|Bupivacaine|"20 ml of 0.5% levobupivacaine saline as a placebo~Bupivacaine: local injection~placebo: local injection"
11242622|NCT02497235|BG000|Baseline|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242623|NCT02497235|BG001|Baseline|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11200793|NCT02196324|EG001|Reported Event|Serlopitant|Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
11200794|NCT02196506|BG000|Baseline|Brexpiprazole + ADT|"Phase B: Brexpiprazole +Antidepressant therapy (ADT):~Participants received brexpiprazole 2mg and ADT orally once daily for 6 weeks."
11200795|NCT02196506|BG001|Baseline|Placebo + ADT|"Phase B: Placebo + Antidepressant therapy (ADT):~Participants received matching placebo and ADT orally once daily for 6 weeks"
11200796|NCT02196506|BG002|Baseline|Total|Total of all reporting groups
11200797|NCT02196506|FG000|Participant Flow|Phase A: All ADT (Antidepressant Therapy)|"Participants meeting entrance criteria who were experiencing a major depressive episode with a HAM-D17 Total Score of greater than or equal 18 at baseline were enrolled into an 8-week Single-blind Prospective Treatment Phase (Phase A). All participants received single-blind placebo plus an investigator determined, open-label, ADT. Once assigned to an ADT by the investigator, participants remained on the same ADT for the duration of the trial. At the Week 8 visit, the IWRS (Interactive web response system) determined based on scores entered by the investigator, whether a participant was a Phase A Responder or a Phase A Inadequate Responder."
11200798|NCT02196506|FG001|Participant Flow|Phase B: Brexpiprazole + ADT|Participants received brexpiprazole 2 mg and ADT orally once daily for 6 weeks.
11200799|NCT02196506|FG002|Participant Flow|Phase B: Placebo + ADT|Participants received matching placebo and ADT orally once daily for 6 weeks.
11200800|NCT02196506|FG003|Participant Flow|Phase A +: ALL ADT|Phase A+ included participants who met criteria for a response at the end of the prospective treatment phase (Week 8 visit of Phase A) and participants who were not suitable for randomization in Phase B per the judgment of the investigator or medical monitor. Treatment response in Phase A was determined at the Week 8 visit based on improvement or lack of improvement of the participant's depressive symptoms, which was confirmed by clinical criteria that prospectively defined response. Participant response was determined from clinical data that were entered into the IWRS at each visit. Participants in Phase A+ received single-blind placebo+ADT for an additional 6 weeks, for a total of 14 weeks, and attended visits at Weeks 11 and 14.
11200801|NCT02196506|OG000|Outcome|Brexpiprazole + ADT|"Phase B: Brexpiprazole +Antidepressant therapy (ADT):~Participants received brexpiprazole 2mg and ADT orally once daily for 6 weeks."
11200802|NCT02196506|OG001|Outcome|Placebo + ADT|"Phase B: Placebo + Antidepressant therapy (ADT):~Participants received matching placebo and ADT orally once daily for 6 weeks"
11200803|NCT02196506|EG000|Reported Event|Brexpiprazole + ADT|"Phase B: Brexpiprazole +Antidepressant therapy (ADT):~Participants received brexpiprazole 2mg and ADT orally once daily for 6 weeks."
11200804|NCT02196506|EG001|Reported Event|Placebo + ADT|"Phase B: Placebo + Antidepressant therapy (ADT):~Participants received matching placebo and ADT orally once daily for 6 weeks"
11200805|NCT02196558|BG000|Baseline|E6011: 100 mg|Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200806|NCT02196558|BG001|Baseline|E6011: 200 mg|Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200807|NCT02196558|BG002|Baseline|E6011: 400 mg|Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200808|NCT02196558|BG003|Baseline|Total|Total of all reporting groups
11200809|NCT02196558|FG000|Participant Flow|E6011: 100 mg|Participants received E6011 100 milligram (mg), subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200810|NCT02196558|FG001|Participant Flow|E6011: 200 mg|Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200811|NCT02196558|FG002|Participant Flow|E6011: 400 mg|Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200812|NCT02196558|OG000|Outcome|E6011: 100 mg|Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200813|NCT02196558|OG001|Outcome|E6011: 200 mg|Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200814|NCT02196558|OG002|Outcome|E6011: 400 mg|Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200815|NCT02196558|EG000|Reported Event|E6011: 100 mg|Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200816|NCT02196558|EG001|Reported Event|E6011: 200 mg|Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200817|NCT02196558|EG002|Reported Event|E6011: 400 mg|Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
11200818|NCT02196675|BG000|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
11200819|NCT02196675|BG001|Baseline|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
11200820|NCT02196675|BG002|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
11200821|NCT02196675|BG003|Baseline|Total|Total of all reporting groups
11200822|NCT02196675|FG000|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
11200823|NCT02196675|FG001|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
11200824|NCT02196675|FG002|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
11200825|NCT02196675|OG000|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
11200826|NCT02196675|OG001|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
10800339|NCT01999179|FG000|Participant Flow|Low-molecular-weight Heparin or Direct Oral Anticoagulant|"Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.~Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.~Heparin, Low-Molecular-Weight, or direct oral anticoagulants: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot"
10800340|NCT01999179|OG000|Outcome|Low-molecular-weight Heparin or Direct Oral Anticoagulant|"Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.~Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.~Heparin, Low-Molecular-Weight, or direct oral anticoagulants: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot"
10800341|NCT01999179|EG000|Reported Event|Low-molecular-weight Heparin or Direct Oral Anticoagulant|"Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.~Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.~Heparin, Low-Molecular-Weight, or direct oral anticoagulants: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot"
10800342|NCT01858688|BG000|Baseline|Accuracy of Multi-parametric MRI Relative to Prostate Biopsy|"Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.~Multiparametric MRI: an MRI of the prostate will be performed~Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance"
10800343|NCT01858688|FG000|Participant Flow|Accuracy of Multi-parametric MRI Relative to Prostate Biopsy|"Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.~Multiparametric MRI: an MRI of the prostate will be performed~Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance"
11200827|NCT02196675|OG002|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11200828|NCT02196675|EG000|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
11200829|NCT02196675|EG001|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
11200830|NCT02196675|EG002|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
11242624|NCT02497235|BG002|Baseline|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11200831|NCT02196688|BG000|Baseline|Treatment Arm|"treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200832|NCT02196688|BG001|Baseline|Control Arm|"control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200833|NCT02196688|BG002|Baseline|Total|Total of all reporting groups
11200834|NCT02196688|FG000|Participant Flow|Treatment Arm|"treatment arm- subjects will receive Fruquintinib 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200835|NCT02196688|FG001|Participant Flow|Control Arm|"control arm- subjects will receive Fruquintinib placebo 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200836|NCT02196688|OG000|Outcome|Treatment Arm|"treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200837|NCT02196688|OG001|Outcome|Control Arm|"control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200838|NCT02196688|EG000|Reported Event|Treatment Arm|"treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200839|NCT02196688|EG001|Reported Event|Control Arm|"control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.~placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off"
11200840|NCT02196701|BG000|Baseline|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200841|NCT02196701|BG001|Baseline|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200842|NCT02196701|BG002|Baseline|Total|Total of all reporting groups
11200843|NCT02196701|FG000|Participant Flow|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200844|NCT02196701|OG000|Outcome|Primary Sub-optimal Responders - ADA + MTX|Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200845|NCT02196701|OG001|Outcome|Secondary Sub-optimal Responders - ADA + MTX|Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200846|NCT02196701|OG002|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200847|NCT02196701|OG000|Outcome|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200848|NCT02196701|EG000|Reported Event|Adalimumab + Methotrexate|Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
11200849|NCT02196714|BG000|Baseline|All Subjects|Analysis Set: All Subjects Randomized
11200850|NCT02196714|FG000|Participant Flow|Received GFF MDI 28.8/9.6 μg|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
10800344|NCT01858688|OG000|Outcome|Accuracy of Multi-parametric MRI Relative to Prostate Biopsy|"Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.~Multiparametric MRI: an MRI of the prostate will be performed~Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance"
11200851|NCT02196714|FG001|Participant Flow|Received GFF MDI 14.4/9.6 μg|Received GFF MDI 14.4/9.6 μg
11200852|NCT02196714|FG002|Participant Flow|Received GP MDI 28.8 μg|Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
11200853|NCT02196714|FG003|Participant Flow|Received GP MDI 14.4 μg|Received GP MDI 14.4 μg
11200854|NCT02196714|OG000|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
11200855|NCT02196714|OG001|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
11200856|NCT02196714|OG002|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
11200857|NCT02196714|OG003|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
11200858|NCT02196714|OG003|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
11200859|NCT02196714|OG002|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
11200860|NCT02196714|EG000|Reported Event|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
11200861|NCT02196714|EG001|Reported Event|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
11200862|NCT02196714|EG002|Reported Event|GP MDI 28.8 ug|GP MDI 28.8 ug
11200863|NCT02196714|EG003|Reported Event|GP MDI 14.4 µg|GP MDI 14.4 µg
11200864|NCT02196766|BG000|Baseline|Bioclean First Care EX / Aosept Clearcare / Comfil|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
11200865|NCT02196766|FG000|Participant Flow|Bioclean First Care EX Combo, Then Aosept Clearcare Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
11200866|NCT02196766|FG001|Participant Flow|Aosept Clearcare Combo First,Then Bioclean First Care EX Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
11200867|NCT02196766|OG000|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
11200868|NCT02196766|OG001|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
11200869|NCT02196766|EG000|Reported Event|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
11242625|NCT02497235|BG003|Baseline|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11200870|NCT02196766|EG001|Reported Event|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
11200871|NCT02196831|BG000|Baseline|Tesamorelin|"tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~tesamorelin"
11200872|NCT02196831|BG001|Baseline|Placebo|"placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~Placebo: inactive substance that looks like tesamorelin"
11200873|NCT02196831|BG002|Baseline|Total|Total of all reporting groups
11200874|NCT02196831|FG000|Participant Flow|Tesamorelin|"tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~tesamorelin"
11200875|NCT02196831|FG001|Participant Flow|Placebo|"placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~Placebo: inactive substance that looks like tesamorelin"
11200876|NCT02196831|OG000|Outcome|Tesamorelin|"tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~tesamorelin"
11200877|NCT02196831|OG001|Outcome|Placebo|"placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~Placebo: inactive substance that looks like tesamorelin"
11200878|NCT02196831|EG000|Reported Event|Tesamorelin (Double-blind Phase)|"tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~tesamorelin"
11200879|NCT02196831|EG001|Reported Event|Placebo (Double-blind Phase)|"placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.~Placebo: inactive substance that looks like tesamorelin"
11200880|NCT02196831|EG002|Reported Event|Open Label Tesamorelin Arm|following the 12 month double-blind period, all subjects received open-label tesamorelin 2mg daily subcutaneously for 6 months.
11200881|NCT02196857|BG000|Baseline|Azacytidine + Sorafenib|"Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously.~Azacytidine: 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.~Sorafenib: 400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle."
10850350|NCT00302068|OG001|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
11242626|NCT02497235|BG004|Baseline|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
11242627|NCT02497235|BG005|Baseline|Total|Total of all reporting groups
11242628|NCT02497235|FG000|Participant Flow|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242629|NCT02497235|FG001|Participant Flow|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242630|NCT02497235|FG002|Participant Flow|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242631|NCT02497235|FG003|Participant Flow|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242632|NCT02497235|FG004|Participant Flow|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
11242633|NCT02497235|OG000|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
11242634|NCT02497235|OG000|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242635|NCT02497235|OG001|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242636|NCT02497235|OG002|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242637|NCT02497235|OG003|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
11242638|NCT02497235|OG004|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
11242639|NCT02497235|OG004|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
11242640|NCT02497235|EG000|Reported Event|Baseline [18F]MNI-792|[18F]MNI-792 up to 370 MBq (10mCi) with a mass of up to 5 mcg, injection, intravenously, prior to Positron Emission Tomography (PET) imaging at Baseline.
11242641|NCT02497235|EG001|Reported Event|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242642|NCT02497235|EG002|Reported Event|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242643|NCT02497235|EG003|Reported Event|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242644|NCT02497235|EG004|Reported Event|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11242645|NCT02497235|EG005|Reported Event|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
11242646|NCT02497287|BG000|Baseline|Intranasal Esketamine + Oral Antidepressant|Participants enrolled directly or TRD3005 non-responders self-administered intranasal Esketamine (Esk) twice a week for 4 weeks as age dependent flexible dose according to titration regimen for 56 or 84 milligram (mg) (<65 years) and 28, 56 or 84 mg (>=65 years) in IND phase. Participants who met response criteria at end of IND phase, entered OP/MA phase and received intranasal esketamine weekly from week 5-8 of OP/MA phase. From Week 9-52, participants received Esk either weekly or every other week based on MADRS score. TE (TRD3005 responders) joined OP/MA phase and received intranasal Esk 28, 56 or 84 mg weekly until week 8. DE participants initiated new oral antidepressant (AD) (1 of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]) on Day 1 of IND phase and continued during IND and OP/MA phase. TE participants continued same oral AD from TRD3005. No intranasal Esk was given in follow-up phase and same oral AD was continued at investigator's clinical judgement.
10966263|NCT00886483|BG001|Baseline|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
10966264|NCT00886483|BG002|Baseline|Total|Total of all reporting groups
11200882|NCT02196857|FG000|Participant Flow|Azacytidine + Sorafenib|"Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously.~Azacytidine: 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.~Sorafenib: 400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle."
11242647|NCT02497287|FG000|Participant Flow|Intranasal Esketamine + Oral Antidepressant|Participants enrolled directly or TRD3005 non-responders self-administered intranasal Esketamine (Esk) twice a week for 4 weeks as age dependent flexible dose according to titration regimen for 56 or 84 milligram (mg) (<65 years) and 28, 56 or 84 mg (>=65 years) in IND phase. Participants who met response criteria at end of IND phase, entered OP/MA phase and received intranasal esketamine weekly from week 5-8 of OP/MA phase. From Week 9-52, participants received Esk either weekly or every other week based on MADRS score. TE (TRD3005 responders) joined OP/MA phase and received intranasal Esk 28, 56 or 84 mg weekly until week 8. DE participants initiated new oral antidepressant (AD) (1 of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]) on Day 1 of IND phase and continued during IND and OP/MA phase. TE participants continued same oral AD from TRD3005. No intranasal Esk was given in follow-up phase and same oral AD was continued at investigator's clinical judgement.
11242648|NCT02497287|OG000|Outcome|Intranasal Esketamine + Oral Antidepressant|Participants enrolled directly or TRD3005 non-responders self-administered intranasal Esketamine (Esk) twice a week for 4 weeks as age dependent flexible dose according to titration regimen for 56 or 84 milligram (mg) (<65 years) and 28, 56 or 84 mg (>=65 years) in IND phase. Participants who met response criteria at end of IND phase, entered OP/MA phase and received intranasal esketamine weekly from week 5-8 of OP/MA phase. From Week 9-52, participants received Esk either weekly or every other week based on MADRS score. TE (TRD3005 responders) joined OP/MA phase and received intranasal Esk 28, 56 or 84 mg weekly until week 8. DE participants initiated new oral antidepressant (AD) (1 of: duloxetine/escitalopram/sertraline/venlafaxine extended release [XR]) on Day 1 of IND phase and continued during IND and OP/MA phase. TE participants continued same oral AD from TRD3005. No intranasal Esk was given in follow-up phase and same oral AD was continued at investigator's clinical judgement.
11242649|NCT02497287|EG000|Reported Event|IND: Intranasal Esketamine + Oral AD|Participants enrolled directly or TRD3005 non-responders self-administered intranasal Esk twice a week for 4 weeks as age dependent flexible dose according to titration regimen for 56 or 84 mg (age < 65 years) and 28, 56 or 84 mg (age >=65 years) in IND phase. DE participants initiated new oral AD (1 of: duloxetine/escitalopram/sertraline/venlafaxine XR) on Day 1 of IND phase. TE participants continued same oral AD from TRD3005.
11242650|NCT02497287|EG001|Reported Event|OP/MA: Intranasal Esketamine + Oral AD|Participants who met response criteria at end of IND phase, entered OP/MA phase and received intranasal Esk from Week 5-8 of OP/MA phase at same dose as in IND phase. From Week 9-52, participants received Esk either weekly or every other week depending on MADRS score. TE (TRD3005 responders) joined OP/MA phase and received intranasal Esk 28, 56 or 84 mg weekly until week 8. DE participants continued oral AD (1 of: duloxetine/escitalopram/sertraline/venlafaxine XR) same as in IND phase during OP/MA phase. TE participants continued same oral AD from TRD3005.
11242651|NCT02497287|EG002|Reported Event|FU: Intranasal Esketamine + Oral AD|Participants received no intranasal esketamine and continued same oral AD at the investigator's clinical judgement during 4-week follow-up (FU) phase.
11242652|NCT02497391|BG000|Baseline|Overall Participants|Participants received a single dose of 130 mg evacetrapib tablet (a total of 3 doses of evacetrapib) given one time during each study period.
11242653|NCT02497391|FG000|Participant Flow|Sequence 1 (R/T1/T2)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: R Period 2: T1 Period 3: T2"
11242654|NCT02497391|FG001|Participant Flow|Sequence 2 (T1/T2/R)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1(T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: T1 Period 2: T2 Period 3: R"
11242655|NCT02497391|FG002|Participant Flow|Sequence 3 (T2/R/T1)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: T2 Period 2: R Period 3: T1"
11242656|NCT02497391|FG003|Participant Flow|Sequence 4 (T2/T1/R)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: T2 Period 2: T1 Period 3: R"
11242657|NCT02497391|FG004|Participant Flow|Sequence 5 (R/T2/T1)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: R Period 2: T2 Period 3: T1"
11242658|NCT02497391|FG005|Participant Flow|Sequence 6 (T1/R/T2)|"Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.~All participants received one tablet in Period 1: T1 Period 2: R Period 3: T2"
11242659|NCT02497391|OG000|Outcome|Evacetrapib Reference (R)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11242660|NCT02497391|OG001|Outcome|Evacetrapib Test 1 (T1)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11242661|NCT02497391|OG002|Outcome|Evacetrapib Test 2 (T2)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11242662|NCT02497391|EG000|Reported Event|Evacetrapib Reference (R)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11242663|NCT02497391|EG001|Reported Event|Evacetrapib Test 1 (T1)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11242664|NCT02497391|EG002|Reported Event|Evacetrapib Test 2 (T2)|Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
11339360|NCT03629028|FG001|Participant Flow|Double Layer|Age:18-45 Years,Only women who underwent cesarean section Inclusion Criteria:Primary cesarean, singleton pregnancy, Exclusion Criteria:Multiple pregnancy, History of any uterine surgery, wound healing diseases (insulin dependent diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease) Uterus will be sutured in double layer during cesareanDiagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
11339361|NCT03629028|OG000|Outcome|Single Layer|niche presence
11339362|NCT03629028|OG001|Outcome|Double Layer|niche presence
10800345|NCT01858688|EG000|Reported Event|Accuracy of Multi-parametric MRI Relative to Prostate Biopsy|"Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.~Multiparametric MRI: an MRI of the prostate will be performed~Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance"
10800346|NCT01796197|BG000|Baseline|Treatment Arm|"Run in phase: Trastuzumab IV 4 mg/kg, Pertuzumab IV 840 mg (Day 1, Week 1)~Pre-op phase:~Trastuzumab IV 2 mg/kg weekly, Paclitaxel 80 mg/m2 IV weekly (beginning on Day 8, Week 2) x 16 doses.~Starting Day 21 (week 4) continue trastuzumab and paclitaxel as above and add Pertuzumab 420 mg IV every 3 weeks during 16 doses of paclitaxel administration. After completing 16 doses of Paclitaxel, Trastuzumab (6 mg/kg IV) and Pertuzumab 420 mg IV may be continued every 3 weeks until surgery~Modified Radical Mastectomy~Post-Operative Treatment (Two Options):~Option 1: Adriamycin 60 mg/m2 IV and Cyclophosphamide 600 mg/m2 IV every 2-3 weeks x 4 cycles. Followed by Trastuzumab 8 mg/kg and Pertuzumab 840 IV load; followed by Trastuzumab 6 mg/kg every and Pertuzumab 420 mg IV every 3 weeks to complete 12 months of HER2-directed therapy~Option 2: Continue Trastuzumab 6 mg/kg and Pertuzumab 420 mg every 3 weeks to complete 12 months of HER2-directed therapy~Post-mastectomy radiation therapy to the chest wall and regional lymph nodes and endocrine therapy administered to participants by standard of care."
10800347|NCT01796197|FG000|Participant Flow|Treatment Arm|"Run in phase: Trastuzumab IV 4 mg/kg, Pertuzumab IV 840 mg (Day 1, Week 1)~Pre-op phase:~Trastuzumab IV 2 mg/kg weekly, Paclitaxel 80 mg/m2 IV weekly (beginning on Day 8, Week 2) x 16 doses.~Starting Day 21 (week 4) continue trastuzumab and paclitaxel as above and add Pertuzumab 420 mg IV every 3 weeks during 16 doses of paclitaxel administration. After completing 16 doses of Paclitaxel, Trastuzumab (6 mg/kg IV) and Pertuzumab 420 mg IV may be continued every 3 weeks until surgery~Modified Radical Mastectomy~Post-Operative Treatment (Two Options):~Option 1: Adriamycin 60 mg/m2 IV and Cyclophosphamide 600 mg/m2 IV every 2-3 weeks x 4 cycles. Followed by Trastuzumab 8 mg/kg and Pertuzumab 840 IV load; followed by Trastuzumab 6 mg/kg every and Pertuzumab 420 mg IV every 3 weeks to complete 12 months of HER2-directed therapy~Option 2: Continue Trastuzumab 6 mg/kg and Pertuzumab 420 mg every 3 weeks to complete 12 months of HER2-directed therapy~Post-mastectomy radiation therapy to the chest wall and regional lymph nodes and endocrine therapy administered to participants by standard of care."
10800348|NCT01796197|OG000|Outcome|Treatment Arm|"Run in phase: Trastuzumab IV 4 mg/kg, Pertuzumab IV 840 mg (Day 1, Week 1)~Pre-op phase:~Trastuzumab IV 2 mg/kg weekly, Paclitaxel 80 mg/m2 IV weekly (beginning on Day 8, Week 2) x 16 doses.~Starting Day 21 (week 4) continue trastuzumab and paclitaxel as above and add Pertuzumab 420 mg IV every 3 weeks during 16 doses of paclitaxel administration. After completing 16 doses of Paclitaxel, Trastuzumab (6 mg/kg IV) and Pertuzumab 420 mg IV may be continued every 3 weeks until surgery~Modified Radical Mastectomy~Post-Operative Treatment (Two Options):~Option 1: Adriamycin 60 mg/m2 IV and Cyclophosphamide 600 mg/m2 IV every 2-3 weeks x 4 cycles. Followed by Trastuzumab 8 mg/kg and Pertuzumab 840 IV load; followed by Trastuzumab 6 mg/kg every and Pertuzumab 420 mg IV every 3 weeks to complete 12 months of HER2-directed therapy~Option 2: Continue Trastuzumab 6 mg/kg and Pertuzumab 420 mg every 3 weeks to complete 12 months of HER2-directed therapy~Post-mastectomy radiation therapy to the chest wall and regional lymph nodes and endocrine therapy administered to participants by standard of care."
10800349|NCT01796197|EG000|Reported Event|Treatment Arm|"Pre-op phase:~Trastuzumab: IV 4mg/kg/first dose, then IV 2mg/kg weekly. Pertuzumab: IV 840mg/first dose, then IV 420mg every 3 weeks Paclitaxel: IV 80mg/m2 weekly x 16 doses Trastuzumab (6 mg/kg IV) and Pertuzumab 420 mg IV may be continued every 3 weeks until surgery.~Surgery: Modified Radical Mastectomy~Post-Operative Treatment:~Option 1: Adriamycin 60 mg/m2 IV and Cyclophosphamide 600 mg/m2 IV every 2-3 weeks x 4 cycles. Followed by Trastuzumab 8 mg/kg and Pertuzumab 840 IV load; followed by Trastuzumab 6 mg/kg every and Pertuzumab 420 mg IV every 3 weeks to complete 12 months of HER2-directed therapy~Option 2: Continue Trastuzumab 6 mg/kg and Pertuzumab 420 mg every 3 weeks to complete 12 months of HER2-directed therapy~All patients should also complete radiation therapy."
10800350|NCT01751906|BG000|Baseline|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800351|NCT01751906|BG001|Baseline|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800352|NCT01751906|BG002|Baseline|Total|Total of all reporting groups
11200883|NCT02196857|OG000|Outcome|Azacytidine + Sorafenib|"Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously.~Azacytidine: 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.~Sorafenib: 400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle."
11339363|NCT03629028|OG000|Outcome|Single Layer|single layer median depth of niche
11339364|NCT03629028|OG001|Outcome|Double Layer|double layer median depth of niche
11339365|NCT03629028|OG000|Outcome|Single Layer|median length niche
11339366|NCT03629028|OG001|Outcome|Double Layer|median length niche
11339367|NCT03629028|OG000|Outcome|Single Layer|median niche width in transverse plane
11339368|NCT03629028|OG001|Outcome|Double Layer|median niche width in transverse plane
11200884|NCT02196857|EG000|Reported Event|Azacytidine + Sorafenib|"Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously.~Azacytidine: 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.~Sorafenib: 400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle."
11200885|NCT02196922|BG000|Baseline|Comprehensive Outpatient Management (COM)|"Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic."
11200886|NCT02196922|BG001|Baseline|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
11200887|NCT02196922|BG002|Baseline|Total|Total of all reporting groups
11200888|NCT02196922|FG000|Participant Flow|Comprehensive Outpatient Management (COM-Standard of Care)|"Patients in the control group will receive comprehensive outpatient management (COM)at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: Patients receiving COM experience chronic care management received by disparity patients at a heart failure clinic."
11339369|NCT03629028|OG000|Outcome|Single Layer|Residual myometrium thickness
11339370|NCT03629028|OG001|Outcome|Double Layer|Residual myometrium thickness
11339371|NCT03629028|OG000|Outcome|Single Layer|Adjacent myometrium thickness
11339372|NCT03629028|OG001|Outcome|Double Layer|adjacent myometrium thickness
11339373|NCT03629028|EG000|Reported Event|Single Layer-|Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness
11339374|NCT03629028|EG001|Reported Event|Double Layer|Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness
11339375|NCT03629041|BG000|Baseline|All Study Participants|All study participants
11339376|NCT03629041|FG000|Participant Flow|Treatment Group 1|"At visit 1 the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339377|NCT03629041|FG001|Participant Flow|Treatment Group 2|"At visit 1 the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339378|NCT03629041|FG002|Participant Flow|Treatment Group 3|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339379|NCT03629041|FG003|Participant Flow|Treatment Group 4|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339380|NCT03629041|OG000|Outcome|Treatment A - Microneedle Patch, Palatal|The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
11339381|NCT03629041|OG001|Outcome|Treatment B - Patch With no Microneedles, Palatal|The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
11339382|NCT03629041|OG002|Outcome|Treatment A - Microneedle Patch, Buccal|The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
11339383|NCT03629041|OG003|Outcome|Treatment B - Patch With no Microneedles, Buccal|The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
11339384|NCT03629041|OG000|Outcome|Treatment A - Microneedle Patch, Palatal|5% topical lidocaine gel was applied to the upper palatal area within the participants mouth using a microneedle patch. The microneedle patch was applied for 3 minutes and then removed, followed by tests 1, 2 and 3.
11339385|NCT03629041|OG001|Outcome|Treatment B - Patch With no Microneedles, Palatal|5% topical lidocaine gel was applied to the upper palatal area within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied for 3 minutes and then removed, followed by tests 1, 2 and 3.
10849969|NCT00299494|BG004|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11339386|NCT03629041|OG002|Outcome|Treatment A - Microneedle Patch, Buccal|5% topical lidocaine gel was applied to the upper anterior buccal sulcus within the participants mouth using a microneedle patch. The microneedle patch was applied for 3 minutes and then removed, followed by tests 1, 2 and 3.
11339387|NCT03629041|OG003|Outcome|Treatment B - Patch With no Microneedles, Buccal|5% topical lidocaine gel was applied to the upper anterior buccal sulcus within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied for 3 minutes and then removed, followed by tests 1, 2 and 3.
11339388|NCT03629041|OG000|Outcome|Treatment Group 1|"At visit 1 the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339389|NCT03629041|OG001|Outcome|Treatment Group 2|"At visit 1 the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339390|NCT03629041|OG002|Outcome|Treatment Group 3|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339391|NCT03629041|OG003|Outcome|Treatment Group 4|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339392|NCT03629041|EG000|Reported Event|Treatment Group 1|"At visit 1 the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339393|NCT03629041|EG001|Reported Event|Treatment Group 2|"At visit 1 the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339394|NCT03629041|EG002|Reported Event|Treatment Group 3|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days from visit 1) the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339395|NCT03629041|EG003|Reported Event|Treatment Group 4|"At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.~At visit 2 (2 weeks +/- 3 days after visit 1) the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites."
11339396|NCT03629054|BG000|Baseline|Test Treatment (T)/ Reference Treatment (R)|Participants were administered 2 fixed dose combination (FDC) coated tablet of 5 milligram(mg) empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin extended release (XR) orally in the fed state in period 1, followed by free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR in the fed state in period 2. The T and R treatments were separated by a washout period of at least 35 days.
11339397|NCT03629054|BG001|Baseline|Reference Treatment (R)/ Test Treatment (T)|Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state in period 1 and followed by 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state in period 2. The T and R treatments were separated by a washout period of at least 35 days.
11339398|NCT03629054|BG002|Baseline|Total|Total of all reporting groups
11200889|NCT02196922|FG001|Participant Flow|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
11200890|NCT02196922|OG000|Outcome|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic."
11200891|NCT02196922|OG001|Outcome|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
11200892|NCT02196922|OG000|Outcome|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic."
11339399|NCT03629054|FG000|Participant Flow|Test Treatment (T)/ Reference Treatment (R)|Participants were administered 2 fixed dose combination (FDC) coated tablets of 5 milligram (mg) empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin extended release (XR) orally as a single dose in the fed state in period 1, followed by the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state in period 2. The T and R treatments were separated by a washout period of at least 35 days.
11339400|NCT03629054|FG001|Participant Flow|Reference Treatment (R)/ Test Treatment (T)|Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state in period 1 and followed by 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state in period 2. The T and R treatments were separated by a washout period of at least 35 days.
11339401|NCT03629054|OG000|Outcome|Test Treatment (T)|Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state.
11339402|NCT03629054|OG001|Outcome|Reference Treatment (R)|Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state.
11339403|NCT03629054|EG000|Reported Event|Test Treatment (T)|Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state.
11339404|NCT03629054|EG001|Reported Event|Reference Treatment (R)|Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state.
11339405|NCT03629184|BG000|Baseline|Baloxavir Marboxil|Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
11339406|NCT03629184|BG001|Baseline|Oseltamivir|Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
11339407|NCT03629184|BG002|Baseline|Total|Total of all reporting groups
11339408|NCT03629184|FG000|Participant Flow|Baloxavir Marboxil|Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
11339409|NCT03629184|FG001|Participant Flow|Oseltamivir|Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
11339410|NCT03629184|OG000|Outcome|Baloxavir Marboxil|Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
11339411|NCT03629184|OG001|Outcome|Oseltamivir|Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
11339412|NCT03629184|EG000|Reported Event|Baloxavir Marboxil|Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
11339413|NCT03629184|EG001|Reported Event|Oseltamivir|Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
11339414|NCT03629249|BG000|Baseline|QAW039 150 mg|QAW039 150 mg once daily orally
11339415|NCT03629249|BG001|Baseline|QAW039 450 mg|QAW039 450 mg once daily orally
11339416|NCT03629249|BG002|Baseline|Placebo|Placebo to QAW039 once daily orally
11339417|NCT03629249|BG003|Baseline|Total|Total of all reporting groups
11339418|NCT03629249|FG000|Participant Flow|QAW039 150 mg|QAW039 150 mg once daily orally
11339419|NCT03629249|FG001|Participant Flow|QAW039 450 mg|QAW039 450 mg once daily orally
11339420|NCT03629249|FG002|Participant Flow|Placebo|Placebo to QAW039 once daily orally
11339421|NCT03629249|OG000|Outcome|QAW039 150 mg|QAW039 150 mg once daily orally
11339422|NCT03629249|OG001|Outcome|QAW039 450 mg|QAW039 450 mg once daily orally
11339423|NCT03629249|OG002|Outcome|Placebo|Placebo to QAW039 once daily orally
11339424|NCT03629249|EG000|Reported Event|QAW039 150mg|QAW039 150mg once daily orally
11339425|NCT03629249|EG001|Reported Event|QAW039 450mg|QAW039 450mg once daily orally
11339426|NCT03629249|EG002|Reported Event|Placebo|Placebo to QAW039 once daily orally
11339427|NCT03629535|BG000|Baseline|Patients in SICU|"Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.~Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.~Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control"
11339428|NCT03629535|FG000|Participant Flow|Patients in SICU|"Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.~Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.~Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control"
11339429|NCT03629535|OG000|Outcome|Patients in SICU|"Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.~Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.~Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control"
11200893|NCT02196922|OG001|Outcome|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.
11200894|NCT02196922|EG000|Reported Event|Comprehensive Outpatient Management (COM)|"Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.~Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic."
11200895|NCT02196922|EG001|Reported Event|Telehealth Self Management (TSM)|Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.
11200896|NCT02197065|BG000|Baseline|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
11200897|NCT02197065|BG001|Baseline|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
11200898|NCT02197065|BG002|Baseline|Total|Total of all reporting groups
11200899|NCT02197065|FG000|Participant Flow|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
11200900|NCT02197065|FG001|Participant Flow|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
11200901|NCT02197065|OG000|Outcome|All Patients|All patients in the study
11200902|NCT02197065|OG000|Outcome|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
11200903|NCT02197065|OG001|Outcome|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
11200904|NCT02197065|OG000|Outcome|Atorvastatin|Atorvastatin 40mg daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
11200905|NCT02197065|OG001|Outcome|Sugar Pill|Sugar pill (placebo) daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
11200906|NCT02197065|EG000|Reported Event|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
11200907|NCT02197065|EG001|Reported Event|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.~Placebo"
11200908|NCT02197078|BG000|Baseline|Other DPP-4I - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200909|NCT02197078|BG001|Baseline|Linagliptin 1 - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200910|NCT02197078|BG002|Baseline|Pioglitazone - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200911|NCT02197078|BG003|Baseline|Linagliptin 2 - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200912|NCT02197078|BG004|Baseline|2nd Gen SUs - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200913|NCT02197078|BG005|Baseline|Linagliptin 3 - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200914|NCT02197078|BG006|Baseline|Other DPP-4I - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200915|NCT02197078|BG007|Baseline|Linagliptin 1 - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200916|NCT02197078|BG008|Baseline|Pioglitazone - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200917|NCT02197078|BG009|Baseline|Linagliptin 2 - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200918|NCT02197078|BG010|Baseline|2nd Gen SUs - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200919|NCT02197078|BG011|Baseline|Linagliptin 3 - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200920|NCT02197078|BG012|Baseline|Total|Total of all reporting groups
11342466|NCT03708211|BG000|Baseline|Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet|TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342467|NCT03708211|BG001|Baseline|Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC|TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342468|NCT03708211|BG002|Baseline|Total|Total of all reporting groups
11342469|NCT03708211|FG000|Participant Flow|Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet|TAK-931 80 milligram (mg), powder in capsule (PIC), orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until progressive disease (PD), or unacceptable toxicity or any treatment discontinuation is determined.
11342470|NCT03708211|FG001|Participant Flow|Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC|TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342471|NCT03708211|OG000|Outcome|TAK-931 80 mg PIC|TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342472|NCT03708211|OG001|Outcome|TAK-931 80 mg Tablet|TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342473|NCT03708211|OG000|Outcome|Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet|TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342474|NCT03708211|OG001|Outcome|Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC|TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342475|NCT03708211|EG000|Reported Event|Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet|TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342476|NCT03708211|EG001|Reported Event|Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC|TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
11342477|NCT03708367|BG000|Baseline|Study Group|LipiFlow treatment at Pre-operative
11342478|NCT03708367|BG001|Baseline|Control Group|LipiFlow treatment following 3-month visit
11342479|NCT03708367|BG002|Baseline|Total|Total of all reporting groups
11342480|NCT03708367|FG000|Participant Flow|Study Group|LipiFlow treatment at Pre-operative
11342481|NCT03708367|FG001|Participant Flow|Control Group|LipiFlow treatment following 3-month visit
11342482|NCT03708367|OG000|Outcome|Study Group|LipiFlow treatment at Pre-operative
11342483|NCT03708367|OG001|Outcome|Control Group|LipiFlow treatment following 3-month visit
11342484|NCT03708367|EG000|Reported Event|Study Group|LipiFlow treatment at Pre-operative
11342485|NCT03708367|EG001|Reported Event|Control Group|Prior to LipiFlow treatment at 3-month visit
11342486|NCT03708367|EG002|Reported Event|Control Group|AEs occurring after LipiFlow treatment
11342487|NCT03708393|BG000|Baseline|Overall (Subjects Randomly Selected From PIONEER-01 Study)|Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.
10850351|NCT00302068|OG002|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
11339430|NCT03629535|EG000|Reported Event|Patients in SICU|"Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.~Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.~Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control"
11339431|NCT03629886|BG000|Baseline|Vacc-039 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study.
11339432|NCT03629886|BG001|Baseline|Vacc-092 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.
11339433|NCT03629886|BG002|Baseline|Total|Total of all reporting groups
11339434|NCT03629886|FG000|Participant Flow|Vacc-039 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study.
11339435|NCT03629886|FG001|Participant Flow|Vacc-092 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.
11339436|NCT03629886|OG000|Outcome|Vacc-092 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.
11339437|NCT03629886|OG000|Outcome|Vacc-039 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study.
11339438|NCT03629886|OG001|Outcome|Vacc-092 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.
11339439|NCT03629886|EG000|Reported Event|Vacc-039 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study.
11339440|NCT03629886|EG001|Reported Event|Vacc-092 Group|Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.
11340276|NCT03650387|FG000|Participant Flow|RADIESSE® (+) Lidocaine: All Participants|Participants received study medical device (SMD) (RADIESSE® [+] Lidocaine) on Day 1 with volume for each area to be treated and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations. A minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss) per participant were treated. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340277|NCT03650387|OG000|Outcome|RADIESSE® (+) Lidocaine: Nasolabial Folds|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340278|NCT03650387|OG000|Outcome|RADIESSE® (+) Lidocaine: Marionette Lines|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340279|NCT03650387|OG000|Outcome|RADIESSE® (+) Lidocaine: Cheek Volume Loss|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340280|NCT03650387|OG001|Outcome|RADIESSE® (+) Lidocaine: Marionette Lines|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340281|NCT03650387|OG002|Outcome|RADIESSE® (+) Lidocaine: Cheek Volume Loss|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340282|NCT03650387|OG003|Outcome|RADIESSE® (+) Lidocaine: All Participants|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
11339441|NCT03629925|BG000|Baseline|Sintilimab+ Gemcitabine Plus Platinum|Sintilimab 200mg IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339442|NCT03629925|BG001|Baseline|Placebo+Gemcitabine Plus Platinum|Placebo IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339443|NCT03629925|BG002|Baseline|Total|Total of all reporting groups
11339444|NCT03629925|FG000|Participant Flow|Sintilimab+ Gemcitabine Plus Platinum|Sintilimab 200mg IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339445|NCT03629925|FG001|Participant Flow|Placebo+Gemcitabine Plus Platinum|Placebo IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339446|NCT03629925|OG000|Outcome|Sintilimab+ Gemcitabine Plus Platinum|Sintilimab 200mg IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339447|NCT03629925|OG001|Outcome|Placebo+Gemcitabine Plus Platinum|Placebo IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339448|NCT03629925|EG000|Reported Event|Sintilimab+ Gemcitabine Plus Platinum|Sintilimab 200mg IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339449|NCT03629925|EG001|Reported Event|Placebo+Gemcitabine Plus Platinum|Placebo IV, Gemcitabine 1.0 g/m^2 IV and Cisplatin 75 mg/m^2 or Carboplatin AUC 5 mg/ml/min IV Q3W.
11339450|NCT03630016|BG000|Baseline|Owlet Smart Sock V2 v1.1|Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
11339451|NCT03630016|FG000|Participant Flow|Owlet Smart Sock V2 v1.1|Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
11339452|NCT03630016|OG000|Outcome|Owlet Smart Sock V2 v1.1|Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
11339453|NCT03630016|EG000|Reported Event|Owlet Smart Sock V2 v1.1|Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
11339454|NCT03630185|BG000|Baseline|Off-the-rack Stockings (Sigvaris)|"Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.~Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb."
11339455|NCT03630185|BG001|Baseline|Custom-manufactured Compression Hosiery (Isobar)|"The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.~Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb."
11339456|NCT03630185|BG002|Baseline|Total|Total of all reporting groups
11339457|NCT03630185|FG000|Participant Flow|Off-the-rack Stockings (Sigvaris)|"Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.~Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb."
11339458|NCT03630185|FG001|Participant Flow|Custom-manufactured Compression Hosiery (Isobar)|"The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.~Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb."
11339459|NCT03630185|OG000|Outcome|Off-the-rack Stockings (Sigvaris)|"Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.~Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb."
11339460|NCT03630185|OG001|Outcome|Custom-manufactured Compression Hosiery (Isobar)|"The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.~Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb."
11200921|NCT02197078|FG000|Participant Flow|Other DPP-4I - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200922|NCT02197078|FG001|Participant Flow|Linagliptin 1 - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200923|NCT02197078|FG002|Participant Flow|Pioglitazone - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200924|NCT02197078|FG003|Participant Flow|Linagliptin 2 - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200925|NCT02197078|FG004|Participant Flow|2nd Gen SUs - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
10850352|NCT00302068|OG002|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
11200926|NCT02197078|FG005|Participant Flow|Linagliptin 3 - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200927|NCT02197078|FG006|Participant Flow|Other DPP-4I - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200928|NCT02197078|FG007|Participant Flow|Linagliptin 1 - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200929|NCT02197078|FG008|Participant Flow|Pioglitazone - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200930|NCT02197078|FG009|Participant Flow|Linagliptin 2 - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200931|NCT02197078|FG010|Participant Flow|2nd Gen SUs - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200932|NCT02197078|FG011|Participant Flow|Linagliptin 3 - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200933|NCT02197078|OG000|Outcome|Other DPP-4I - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200934|NCT02197078|OG001|Outcome|Linagliptin 1 - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200935|NCT02197078|OG002|Outcome|Pioglitazone - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200936|NCT02197078|OG003|Outcome|Linagliptin 2 - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200937|NCT02197078|OG004|Outcome|2nd Gen SUs - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200938|NCT02197078|OG005|Outcome|Linagliptin 3 - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11340283|NCT03650387|OG000|Outcome|RADIESSE® (+) Lidocaine: Nasolabial Folds|Participants received SMD (RADIESSE® (+) Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340284|NCT03650387|EG000|Reported Event|RADIESSE® (+) Lidocaine: Nasolabial Folds|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340285|NCT03650387|EG001|Reported Event|RADIESSE® (+) Lidocaine: Marionette Lines|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340286|NCT03650387|EG002|Reported Event|RADIESSE® (+) Lidocaine: Cheek Volume Loss|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340287|NCT03650387|EG003|Reported Event|RADIESSE® (+) Lidocaine: All Participants|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
11340288|NCT03650400|BG000|Baseline|Cohort A Fevipiprant 75 mg|QAW039 75 mg Chewable tablet
11340289|NCT03650400|BG001|Baseline|Cohort B Feviprant 375 mg|QAW039 375 mg Chewable tablet
11340290|NCT03650400|BG002|Baseline|Total|Total of all reporting groups
11340291|NCT03650400|FG000|Participant Flow|Cohort A Fevipiprant 75 mg|QAW039 75 mg Chewable tablet
11340292|NCT03650400|FG001|Participant Flow|Cohort B Feviprant 375 mg|QAW039 375 mg Chewable tablet
11340293|NCT03650400|OG000|Outcome|Cohort A Fevipiprant 75 mg|QAW039 75 mg Chewable tablet
11340294|NCT03650400|OG001|Outcome|Cohort B Feviprant 375 mg|QAW039 375 mg Chewable tablet
11340295|NCT03650400|EG000|Reported Event|Cohort A Fevipiprant 75 mg|QAW039 75 mg Chewable tablet
11340296|NCT03650400|EG001|Reported Event|Cohort B Feviprant 375 mg|QAW039 375 mg Chewable tablet
11340297|NCT03650452|BG000|Baseline|Placebo|TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20.
11340298|NCT03650452|BG001|Baseline|TAK-935|TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
11340299|NCT03650452|BG002|Baseline|Total|Total of all reporting groups
11340300|NCT03650452|FG000|Participant Flow|Placebo|TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20.
11340301|NCT03650452|FG001|Participant Flow|TAK-935|TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
11340302|NCT03650452|OG000|Outcome|Placebo|TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20.
11340303|NCT03650452|OG001|Outcome|TAK-935|TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
11340304|NCT03650452|EG000|Reported Event|Placebo|TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20.
11340305|NCT03650452|EG001|Reported Event|TAK-935|TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
11340306|NCT03650842|BG000|Baseline|Laparoscopic Pyloromyotomy|Patients undergoing laparoscopic pyloromyotomy.
11340307|NCT03650842|FG000|Participant Flow|Laparoscopic Pyloromyotomy|Infants undergoing laparoscopic pyloromyotomy.
11340308|NCT03650842|OG000|Outcome|Laparoscopic Pyloromyotomy|Infants undergoing laparoscopic pyloromyotomy.
11340309|NCT03650842|EG000|Reported Event|Laparoscopic Pyloromyotomy|Infants undergoing laparoscopic pyloromyotomy.
11340310|NCT03651479|BG000|Baseline|Real Boxing Group|"In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.~real boxing training: In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks."
11340311|NCT03651479|BG001|Baseline|Virtual Boxing Group|"In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.~virtual boxing training: In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks."
10966265|NCT00886483|FG000|Participant Flow|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
11242665|NCT02497404|BG000|Baseline|5 Azacytidine|"Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor.~5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible.~Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.~Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3.~Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.~TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3)."
11242666|NCT02497404|FG000|Participant Flow|5 Azacytidine|"Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor.~5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible.~Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.~Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3.~Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.~TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3)."
11242667|NCT02497404|OG000|Outcome|5 Azacytidine|"Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor.~5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible.~Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.~Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3.~Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.~TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3)."
11242668|NCT02497404|EG000|Reported Event|5 Azacytidine|"Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation (TBI) prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor.~5-Azacytidine: Patients will be given a five day course of subcutaneous 5-Azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. AZA 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9, -8 and -7. This will be administered on an outpatient basis if possible.~Fludarabine (conditioning regimen): Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.~Melphalan (conditioning regimen): Melphalan will be given at 140 mg/m2 IV on day -3.~Alemtuzumab (conditioning regimen): Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.~TBI (conditioning regimen): TBI will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3)."
11242669|NCT02497469|BG000|Baseline|Adalimumab SC, 160/80/40 mg|Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
11242670|NCT02497469|BG001|Baseline|Vedolizumab IV 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
11242671|NCT02497469|BG002|Baseline|Total|Total of all reporting groups
11242672|NCT02497469|FG000|Participant Flow|Adalimumab SC, 160/80/40 mg|Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
11242673|NCT02497469|FG001|Participant Flow|Vedolizumab IV 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
11242674|NCT02497469|OG000|Outcome|Adalimumab SC, 160/80/40 mg|Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
11340312|NCT03651479|BG002|Baseline|Total|Total of all reporting groups
10849970|NCT00299494|BG005|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11242675|NCT02497469|OG001|Outcome|Vedolizumab IV 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
10849971|NCT00299494|BG006|Baseline|Total|Total of all reporting groups
11242676|NCT02497469|EG000|Reported Event|Adalimumab SC, 160/80/40 mg|Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
11242677|NCT02497469|EG001|Reported Event|Vedolizumab IV 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
11200939|NCT02197078|OG006|Outcome|Other DPP-4I - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200940|NCT02197078|OG007|Outcome|Linagliptin 1 - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200941|NCT02197078|OG008|Outcome|Pioglitazone - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200942|NCT02197078|OG009|Outcome|Linagliptin 2 - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200943|NCT02197078|OG010|Outcome|2nd Gen SUs - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200944|NCT02197078|OG011|Outcome|Linagliptin 3 - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200945|NCT02197078|EG000|Reported Event|Other DPP-4I - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200946|NCT02197078|EG001|Reported Event|Linagliptin 1 - Clinformatics|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database
11200947|NCT02197078|EG002|Reported Event|Pioglitazone - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200948|NCT02197078|EG003|Reported Event|Linagliptin 2 - Clinformatics|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database
11200949|NCT02197078|EG004|Reported Event|2nd Gen SUs - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200950|NCT02197078|EG005|Reported Event|Linagliptin 3 - Clinformatics|1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database
11200951|NCT02197078|EG006|Reported Event|Other DPP-4I - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200952|NCT02197078|EG007|Reported Event|Linagliptin 1 - MarketScan|1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database
11200953|NCT02197078|EG008|Reported Event|Pioglitazone - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200954|NCT02197078|EG009|Reported Event|Linagliptin 2 - MarketScan|1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database
11200955|NCT02197078|EG010|Reported Event|2nd Gen SUs - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200956|NCT02197078|EG011|Reported Event|Linagliptin 3 - MarketScan|1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
11200957|NCT02197130|BG000|Baseline|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200958|NCT02197130|BG001|Baseline|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200959|NCT02197130|BG002|Baseline|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200960|NCT02197130|BG003|Baseline|Total|Total of all reporting groups
11200961|NCT02197130|FG000|Participant Flow|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200962|NCT02197130|FG001|Participant Flow|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200963|NCT02197130|FG002|Participant Flow|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200964|NCT02197130|OG000|Outcome|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200965|NCT02197130|OG001|Outcome|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200966|NCT02197130|OG002|Outcome|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200967|NCT02197130|EG000|Reported Event|PF-02545920 5 mg BID|Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200968|NCT02197130|EG001|Reported Event|Placebo|Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200969|NCT02197130|EG002|Reported Event|PF-02545920 20 mg BID|The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
11200970|NCT02197247|BG000|Baseline|AZD9291 and Rifampicin (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone, followed by AZD9291 + rifampicin, followed by AZD9291 alone. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
11200971|NCT02197247|FG000|Participant Flow|AZD9291 and Rifampicin (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone, followed by AZD9291 + rifampicin, followed by AZD9291 alone. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
11200972|NCT02197247|OG000|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
11200973|NCT02197247|OG001|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
11200974|NCT02197247|OG001|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
11200975|NCT02197247|OG002|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
11200976|NCT02197247|OG000|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
11200977|NCT02197247|EG000|Reported Event|Overall|Parts A and B of the study combined.
11200978|NCT02197247|EG001|Reported Event|Part A|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 77 days (Days 1 to 77) and additionally received 600 mg oral doses of rifampicin once daily on Days 29 to 49.
11200979|NCT02197247|EG002|Reported Event|Part B|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
11200980|NCT02197273|BG000|Baseline|Standard of Care Analgesia|"THA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
10849972|NCT00299494|FG000|Participant Flow|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849973|NCT00299494|FG001|Participant Flow|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11200981|NCT02197273|BG001|Baseline|Liposomal Bupivacaine|"THA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
11200982|NCT02197273|BG002|Baseline|Total|Total of all reporting groups
11200983|NCT02197273|FG000|Participant Flow|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
11242678|NCT02497755|BG000|Baseline|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
11242679|NCT02497755|BG001|Baseline|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
11242680|NCT02497755|BG002|Baseline|Total|Total of all reporting groups
11242681|NCT02497755|FG000|Participant Flow|Patient Mobile App Users|Participants installed an app on their smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
11242682|NCT02497755|FG001|Participant Flow|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
11242683|NCT02497755|OG000|Outcome|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
11242684|NCT02497755|OG000|Outcome|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
11242685|NCT02497755|OG000|Outcome|Patient Mobile App Users|Participants installed an app on their smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
11242686|NCT02497755|EG000|Reported Event|Patient Mobile App Users|Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app.
11242687|NCT02497755|EG001|Reported Event|Care Manager Dashboard User|The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
11242688|NCT02497781|BG000|Baseline|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242689|NCT02497781|BG001|Baseline|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242690|NCT02497781|BG002|Baseline|Total|Total of all reporting groups
11242691|NCT02497781|FG000|Participant Flow|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11200984|NCT02197273|FG001|Participant Flow|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
11242692|NCT02497781|FG001|Participant Flow|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11200985|NCT02197273|OG000|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
11200986|NCT02197273|OG001|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
11200987|NCT02197273|EG000|Reported Event|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
11200988|NCT02197273|EG001|Reported Event|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
11200989|NCT02197377|BG000|Baseline|Group LMA Unique|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion."
11200990|NCT02197377|BG001|Baseline|Group LMA Supreme|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion."
11200991|NCT02197377|BG002|Baseline|Total|Total of all reporting groups
11200992|NCT02197377|FG000|Participant Flow|Group LMA Unique|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion."
11200993|NCT02197377|FG001|Participant Flow|Group LMA Supreme|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion."
11200994|NCT02197377|OG000|Outcome|Group LMA Unique|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion."
11200995|NCT02197377|OG001|Outcome|Group LMA Supreme|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion."
11200996|NCT02197377|EG000|Reported Event|Group LMA Unique|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion."
11200997|NCT02197377|EG001|Reported Event|Group LMA Supreme|"The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.~Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion."
11200998|NCT02197416|BG000|Baseline|Dabigatran Etexilate (0 to < 2 Years)|"Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.~Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 0 to <2 years."
10849974|NCT00299494|FG002|Participant Flow|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11200999|NCT02197416|BG001|Baseline|Dabigatran Etexilate (2 to <12 Years)|"Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and <12 years.~Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 2 to < 12 years."
11201000|NCT02197416|BG002|Baseline|Dabigatran Etexilate (12 to <18 Years)|"Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 12 to <18 years."
11201001|NCT02197416|BG003|Baseline|Total|Total of all reporting groups
11201002|NCT02197416|FG000|Participant Flow|Dabigatran Etexilate (0 to < 2 Years)|"Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.~Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 0 to <2 years."
11201003|NCT02197416|FG001|Participant Flow|Dabigatran Etexilate (2 to <12 Years)|"Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and <12 years.~Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 2 to < 12 years."
11201004|NCT02197416|FG002|Participant Flow|Dabigatran Etexilate (12 to <18 Years)|"Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 12 to <18 years."
11201005|NCT02197416|OG000|Outcome|Dabigatran Etexilate (0 to < 2 Years)|"Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.~Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 0 to <2 years."
11201006|NCT02197416|OG001|Outcome|Dabigatran Etexilate (2 to <12 Years)|"Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and <12 years.~Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 2 to < 12 years."
11242693|NCT02497781|OG000|Outcome|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242694|NCT02497781|OG001|Outcome|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242695|NCT02497781|EG000|Reported Event|Ceftazidime- Avibactam (CAZ-AVI)|Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received single IV infusion of CAZ/AVI for 2 hour in following manner: 1) Age 6 to less than (<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3) Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. The infusion was administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 14 days. Dose of CAZ-AVI was reduced to 50 percent if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl drops below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242696|NCT02497781|EG001|Reported Event|Cefepime|Participants received intravenous (IV) infusion of cefepime, at a dose and frequency prescribed by investigator's (maximum dose of cefepime in any single infusion not exceed 2000 mg every 12 hours). After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
11242697|NCT02497937|BG000|Baseline|All Treatment Combined|Eligible participants were randomized to one of two treatment sequences AP and PA where A=GSK2798745 2.4 mg and P=Placebo. In sequence AP, participants received GSK2798745 2.4 milligrams (mg) once daily orally with 240 milliliter (mL) water in Period 1 and placebo in Period 2 for 7 days. In sequence PA, participants received placebo in Period 1 and GSK2798745 2.4mg once daily orally with 240 mL water in Period 2 for 7 days. In both sequence AP and PA, treatment periods were separated by a washout period of 14 days. Data represents all treatments combined.
11242698|NCT02497937|FG000|Participant Flow|Sequence A (GSK2798745 2.4 mg)/P (Placebo)|Eligible participants were randomized to one of two treatment sequences AP and PA where A=GSK2798745 2.4 mg and P=Placebo. In this sequence, participants received GSK2798745 2.4 milligrams (mg) once daily orally with 240 milliliter (mL) water in Period 1 and placebo in Period 2 for 7 days. Treatment periods were separated by a washout period of 14 days.
11242699|NCT02497937|FG001|Participant Flow|Sequence P (Placebo)/A (GSK2798745 2.4 mg)|Eligible participants were randomized to one of two treatment sequences AP and PA where A=GSK2798745 2.4 mg and P=Placebo. In this sequence, participants received placebo in Period 1 and GSK2798745 2.4mg once daily orally with 240 mL water in Period 2 for 7 days. Treatment periods were separated by a washout period of 14 days.
11242700|NCT02497937|OG000|Outcome|Placebo|Participants received placebo capsule orally once daily with 240 mL water for a period of 7 days in Periods 1 and 2.
11242701|NCT02497937|OG001|Outcome|GSK2798745 2.4 mg|Participants received GSK2798745 2.4 mg capsule orally once daily with 240 mL water for a period of 7 days in Periods 1 and 2.
11242702|NCT02497937|OG000|Outcome|GSK2798745 2.4 mg|Participants received GSK2798745 2.4 mg capsule orally once daily with 240 mL water for a period of 7 days in Periods 1 and 2.
11242703|NCT02497937|EG000|Reported Event|Placebo|Participants received placebo capsule orally once daily with 240 mL water for a period of 7 days in Periods 1 and 2.
11242704|NCT02497937|EG001|Reported Event|GSK2798745 2.4 mg|Participants received GSK2798745 2.4 mg capsule orally once daily with 240 mL water for a period of 7 days in Periods 1 and 2.
11242705|NCT02497976|BG000|Baseline|Certolizumab Pegol|Experimental drug certolizumab pegol 400mg.
11242706|NCT02497976|BG001|Baseline|Placebo|Normal saline
11242707|NCT02497976|BG002|Baseline|Total|Total of all reporting groups
11242708|NCT02497976|FG000|Participant Flow|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
11242709|NCT02497976|FG001|Participant Flow|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
11242710|NCT02497976|OG000|Outcome|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
11242711|NCT02497976|OG001|Outcome|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
11242712|NCT02497976|EG000|Reported Event|Group 1: Experimental|"Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8~Certolizumab pegol: 400 mg"
11242713|NCT02497976|EG001|Reported Event|Group 2: Placebo Comparator|"Placebo: given subcutaneously at week 0, 2, 4, and week 8~Placebo: Normal saline"
11243317|NCT02502149|OG001|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength Combined) (PK2)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11201007|NCT02197416|OG002|Outcome|Dabigatran Etexilate (12 to <18 Years)|"Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.~This arm includes participants aged between 12 to <18 years."
11201008|NCT02197416|EG000|Reported Event|Dabigatran Etexilate (Treated Set)|"Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.~Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.~Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.~Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and <250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg."
11201009|NCT02197455|BG000|Baseline|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
11201010|NCT02197455|FG000|Participant Flow|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
11201011|NCT02197455|OG000|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
11201012|NCT02197455|EG000|Reported Event|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
11201013|NCT02197481|BG000|Baseline|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
11201014|NCT02197481|BG001|Baseline|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
11201015|NCT02197481|BG002|Baseline|Total|Total of all reporting groups
11201016|NCT02197481|FG000|Participant Flow|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electric knife and blood vessel forceps, but without BiClamp forceps"
11342607|NCT03710590|FG001|Participant Flow|E-cigarette Users|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342608|NCT03710590|OG000|Outcome|Cigarette Smokers|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342609|NCT03710590|OG001|Outcome|E-cigarette Users|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342610|NCT03710590|EG000|Reported Event|Cigarette Smokers|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342611|NCT03710590|EG001|Reported Event|E-cigarette Users|"Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.~Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine"
11342612|NCT03710889|BG000|Baseline|Abaloparatide|Participants self-administered a single daily dose of 80 µg of abaloparatide SC during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.
11342613|NCT03710889|FG000|Participant Flow|Abaloparatide|Participants self-administered a single daily dose of 80 micrograms (µg) of abaloparatide subcutaneously (SC) during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.
11342614|NCT03710889|OG000|Outcome|Abaloparatide|Participants self-administered a single daily dose of 80 µg of abaloparatide SC during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.
11342615|NCT03710889|EG000|Reported Event|Abaloparatide|Participants self-administered a single daily dose of 80 µg of abaloparatide SC during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.
11342616|NCT03711396|BG000|Baseline|Intervention|Participants attended two group visits one month apart to discuss advance care planning and to receive information about advance care planning.
11342617|NCT03711396|FG000|Participant Flow|Advance Care Planning Group Visits - aMCI|Participants with amnestic mild cognitive impairment (aMCI) will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.
11342618|NCT03711396|FG001|Participant Flow|Advance Care Planning Group Visits - Care Partners|Participants who are the care partners of persons with amnestic mild cognitive impairment (aMCI) will attend group visits (with the person with aMCI) to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.
11342619|NCT03711396|OG000|Outcome|Advance Care Planning Group Visits - Persons With aMCI|Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
11342620|NCT03711396|OG000|Outcome|Advance Care Planning Group Visits - Care Partners|Care partners of persons with amnestic mild cognitive impairment who participated in the advance care planning group visits.
11342621|NCT03711396|OG000|Outcome|Advance Care Planning Group Visits - Amnestic Mild Cognitive Impairment|Participants with aMCI completed an evaluation of the intervention prototype.
11342622|NCT03711396|OG001|Outcome|Advance Care Planning Group Visits - Care Partners|Care partners of persons with amnestic Mild Cognitive Impairment who participated in the advance care planning group visits.
11342623|NCT03711396|EG000|Reported Event|Advance Care Planning Group Visits|"Participants will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.~Advance Care Planning Group Visit: Aim 1: The first part of this study will focus on refining and adapting the Advance Care Planning Group Visit intervention so that it meets the needs of persons with amnestic cognitive impairment and a study partner who participates with them.~Aim 2: The second part of the study will pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences."
11342624|NCT03711578|BG000|Baseline|Tenalisib|"Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles~Tenalisib,: BID, Orally"
11342625|NCT03711578|FG000|Participant Flow|Tenalisib|"Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles~Tenalisib,: BID, Orally"
11342626|NCT03711578|OG000|Outcome|Tenalisib|"Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles~Tenalisib,: BID, Orally"
11342627|NCT03711578|EG000|Reported Event|Tenalisib|"Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles~Tenalisib,: BID, Orally"
11342628|NCT03712189|BG000|Baseline|Alaris Pump|Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
10966266|NCT00886483|FG001|Participant Flow|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
10966267|NCT00886483|OG000|Outcome|Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
10966268|NCT00886483|OG001|Outcome|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
10966269|NCT00886483|OG000|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
10966270|NCT00886483|OG001|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
10966271|NCT00886483|OG000|Outcome|Active Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
10966272|NCT00886483|OG001|Outcome|Sham Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
10966273|NCT00886483|OG000|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
10966274|NCT00886483|OG001|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
10966275|NCT00886483|OG000|Outcome|Active Neurofeedback|All participants in the Active group completing 40 treatments
10966276|NCT00886483|OG001|Outcome|Sham Neurofeedback|Participants in the Sham group completing 40 treatments
11342629|NCT03712189|BG001|Baseline|LifeFlow|"Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.~LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release."
11342630|NCT03712189|BG002|Baseline|Total|Total of all reporting groups
11342631|NCT03712189|FG000|Participant Flow|Alaris Pump|Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
11342632|NCT03712189|FG001|Participant Flow|LifeFlow|"Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.~LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release."
11342633|NCT03712189|OG000|Outcome|Alaris Pump|Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
11342634|NCT03712189|OG001|Outcome|LifeFlow|"Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.~LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release."
11342635|NCT03712189|EG000|Reported Event|Alaris Pump|Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
11342636|NCT03712189|EG001|Reported Event|LifeFlow|"Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.~LifeFlow: The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release."
11342637|NCT03712280|BG000|Baseline|Group A: MNK6106 2 Grams (Tid)|Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
11342638|NCT03712280|BG001|Baseline|Group B: MNK6106 4 Grams (Bid)|Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
11342639|NCT03712280|BG002|Baseline|Group C: MNK6106 4 Grams (Tid)|Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
11342640|NCT03712280|BG003|Baseline|Group D: Rifaximin 550 mg (Bid)|Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
11342641|NCT03712280|BG004|Baseline|Total|Total of all reporting groups
11342642|NCT03712280|FG000|Participant Flow|Group A: MNK6106 2 Grams (Tid)|Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
11342643|NCT03712280|FG001|Participant Flow|Group B: MNK6106 4 Grams (Bid)|Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
11342644|NCT03712280|FG002|Participant Flow|Group C: MNK6106 4 Grams (Tid)|Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
11342645|NCT03712280|FG003|Participant Flow|Group D: Rifaximin 550 mg (Bid)|Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
11342646|NCT03712280|OG000|Outcome|Group A: MNK6106 2 Grams (Tid)|Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
11342647|NCT03712280|OG001|Outcome|Group B: MNK6106 4 Grams (Bid)|Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
11342648|NCT03712280|OG002|Outcome|Group C: MNK6106 4 Grams (Tid)|Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
11342649|NCT03712280|OG003|Outcome|Group D: Rifaximin 550 mg (Bid)|Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
11342650|NCT03712280|EG000|Reported Event|Group A: MNK6106 2 Grams (Tid)|Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
11342651|NCT03712280|EG001|Reported Event|Group B: MNK6106 4 Grams (Bid)|Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
11342652|NCT03712280|EG002|Reported Event|Group C: MNK6106 4 Grams (Tid)|Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
11342653|NCT03712280|EG003|Reported Event|Group D: Rifaximin 550 mg (Bid)|Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
11342654|NCT03712449|BG000|Baseline|BELKYRA Treatment|"BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment.~SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10."
11342655|NCT03712449|BG001|Baseline|Non-BELKYRA Treatment|"Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4."
11342656|NCT03712449|BG002|Baseline|Total|Total of all reporting groups
11342657|NCT03712449|FG000|Participant Flow|BELKYRA Treatment|"BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment.~SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10."
11342658|NCT03712449|FG001|Participant Flow|Non-BELKYRA Treatment|"Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4."
11342659|NCT03712449|OG000|Outcome|BELKYRA Treatment|"BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment.~SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10."
11342660|NCT03712449|OG001|Outcome|Non-BELKYRA Treatment|"Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4."
11342661|NCT03712449|EG000|Reported Event|BELKYRA Treatment|"BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 mg [10 mL] in a single treatment.~SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10."
11342662|NCT03712449|EG001|Reported Event|Non-BELKYRA Treatment|"Participants who did not receive BELKYRA. SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5.~Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator.~BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4."
11201017|NCT02197481|FG001|Participant Flow|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
11201018|NCT02197481|OG000|Outcome|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
11201019|NCT02197481|OG001|Outcome|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
11201020|NCT02197481|EG000|Reported Event|Clamp-Crushing Technique|"liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted~Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps"
11201021|NCT02197481|EG001|Reported Event|BiClamp Forceps Hepatectomy|"The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.~BiClamp forceps: liver transection during hepatectomy by BiClamp forceps"
11201022|NCT02197520|BG000|Baseline|All Participants|All participants who received Insulin peglispro, administered SC for 33 days then Insulin glargine, administered SC for 33 days or Insulin glargine, administered SC for 33 days then Insulin peglispro, administered SC for 33 days
11201023|NCT02197520|FG000|Participant Flow|Sequence AB|A: Insulin peglispro, administered SC for 33 days B. Insulin glargine, administered SC for 33 days
11201024|NCT02197520|FG001|Participant Flow|Sequence BA|B. Insulin glargine, administered SC for 33 days A: Insulin peglispro, administered SC for 33 days
11201025|NCT02197520|OG000|Outcome|Insulin Peglispro|Insulin peglispro, a once daily SC
11201026|NCT02197520|OG001|Outcome|Insulin Glargine|Insulin glargine, a once daily SC
11201027|NCT02197520|OG000|Outcome|Insulin Peglispro|Insulin peglispro, once daily SC
11201028|NCT02197520|OG001|Outcome|Insulin Glargine|Insulin peglispro, a once daily SC
11201029|NCT02197520|EG000|Reported Event|Insulin Peglispro|Insulin peglispro, a once daily SC
11201030|NCT02197520|EG001|Reported Event|Insulin Glargine|Insulin glargine, a once daily SC
11201031|NCT02197572|BG000|Baseline|Sapanisertib|Sapanisertib starting dose of 40 mg, capsules, orally, once, on Day 1, Cycle 1 followed by sapanisertib 30 mg, capsules, orally, once weekly (QW) starting on Cycle 1, Day 8 based on safety and tolerability and as per investigator's discretion up to disease progression, unacceptable sapanisertib-related toxicity, withdrawal of consent, or for up to 12 months (whichever occurred first).
11201032|NCT02197572|FG000|Participant Flow|Sapanisertib|Sapanisertib starting dose of 40 mg, capsules, orally, once, on Day 1, Cycle 1 (28 days cycle) followed by sapanisertib 30 mg, capsules, orally, once weekly (QW) starting on Cycle 1, Day 8 based on safety and tolerability and as per investigator's discretion up to disease progression, unacceptable sapanisertib-related toxicity, withdrawal of consent, or for up to 12 months (whichever occurred first).
11201033|NCT02197572|OG000|Outcome|Sapanisertib|Sapanisertib starting dose of 40 mg, capsules, orally, once, on Day 1, Cycle 1 followed by sapanisertib 30 mg, capsules, orally, once weekly (QW) starting on Cycle 1, Day 8 based on safety and tolerability and as per investigator's discretion up to disease progression, unacceptable sapanisertib-related toxicity, withdrawal of consent, or for up to 12 months (whichever occurred first).
11201034|NCT02197572|EG000|Reported Event|Sapanisertib|Sapanisertib starting dose of 40 mg, capsules, orally, once, on Day 1, Cycle 1 followed by sapanisertib 30 mg, capsules, orally, once weekly (QW) starting on Cycle 1, Day 8 based on safety and tolerability and as per investigator's discretion up to disease progression, unacceptable sapanisertib-related toxicity, withdrawal of consent, or for up to 12 months (whichever occurred first).
11201035|NCT02197767|BG000|Baseline|Rituximab|"rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.~rituximab: 1000 mg infusion"
11201036|NCT02197767|FG000|Participant Flow|Rituximab|"rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.~rituximab: 1000 mg infusion"
11201037|NCT02197767|OG000|Outcome|Rituximab|"rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.~rituximab: 1000 mg infusion"
11201038|NCT02197767|EG000|Reported Event|Rituximab|"rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.~rituximab: 1000 mg infusion"
11201039|NCT02197806|BG000|Baseline|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201040|NCT02197806|BG001|Baseline|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11242714|NCT02498067|BG000|Baseline|Intervention|"Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.~6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.~3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."
11242715|NCT02498067|FG000|Participant Flow|Intervention|"Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.~3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."
11242716|NCT02498067|OG000|Outcome|Intervention|"Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.~6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.~3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."
11242717|NCT02498067|OG000|Outcome|Intervention|"Participants will complete a 10-15 minute questionnaire . After completing the questionnaire, a research assistant (RA) will provide a brief orientation to the rPlan app and use the rPlan app for up to 15 minutes. After viewing rPlan, participants will be asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant will also be given an STI test.~rPlan dual protection waiting room app intervention"
11242718|NCT02498067|OG000|Outcome|Intervention|"Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.~3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."
11242719|NCT02498067|EG000|Reported Event|Intervention|"Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.~6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.~3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."
11242720|NCT02498236|BG000|Baseline|8IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242721|NCT02498236|BG001|Baseline|12IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242722|NCT02498236|BG002|Baseline|24IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242723|NCT02498236|BG003|Baseline|36IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242724|NCT02498236|BG004|Baseline|48IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242725|NCT02498236|BG005|Baseline|60IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242726|NCT02498236|BG006|Baseline|72IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242727|NCT02498236|BG007|Baseline|84IU Oxytocin|Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242728|NCT02498236|BG008|Baseline|Total|Total of all reporting groups
11242729|NCT02498236|FG000|Participant Flow|8IU Oxytocin|Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11201041|NCT02197806|BG002|Baseline|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201042|NCT02197806|BG003|Baseline|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
11201043|NCT02197806|BG004|Baseline|Total|Total of all reporting groups
11201044|NCT02197806|FG000|Participant Flow|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201045|NCT02197806|FG001|Participant Flow|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201046|NCT02197806|FG002|Participant Flow|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201047|NCT02197806|FG003|Participant Flow|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
11201048|NCT02197806|OG000|Outcome|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201049|NCT02197806|OG001|Outcome|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201050|NCT02197806|OG002|Outcome|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201051|NCT02197806|OG003|Outcome|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
11201052|NCT02197806|EG000|Reported Event|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201053|NCT02197806|EG001|Reported Event|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201054|NCT02197806|EG002|Reported Event|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
11201055|NCT02197806|EG003|Reported Event|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
11201056|NCT02197897|BG000|Baseline|Tamoxifen|"As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.~Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)"
11201057|NCT02197897|FG000|Participant Flow|Tamoxifen|"As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.~Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)"
11201058|NCT02197897|OG000|Outcome|Tamoxifen|"As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.~Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)"
11201059|NCT02197897|EG000|Reported Event|Tamoxifen|"As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.~Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)"
11201060|NCT02198040|BG000|Baseline|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each.~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
11342702|NCT03714022|BG000|Baseline|Cohort A (New Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process
11342703|NCT03714022|BG001|Baseline|Cohort B (Current Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
11342704|NCT03714022|BG002|Baseline|Total|Total of all reporting groups
10850353|NCT00302068|EG000|Reported Event|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
11201061|NCT02198040|BG001|Baseline|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
11201062|NCT02198040|BG002|Baseline|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
11201063|NCT02198040|BG003|Baseline|Total|Total of all reporting groups
11202355|NCT02207244|OG000|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
11342705|NCT03714022|FG000|Participant Flow|Cohort A (New Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process
11342706|NCT03714022|FG001|Participant Flow|Cohort B (Current Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
11342707|NCT03714022|OG000|Outcome|Cohort A (New Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process
11342708|NCT03714022|OG001|Outcome|Cohort B (Current Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
11342709|NCT03714022|EG000|Reported Event|Cohort A (New Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by a new process
11342710|NCT03714022|EG001|Reported Event|Cohort B (Current Process)|Participants received a single IV infusion (750 mg) of Abatacept drug product converted from drug substance by the current process
10850354|NCT00302068|EG001|Reported Event|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
11201064|NCT02198040|FG000|Participant Flow|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10"
11201065|NCT02198040|FG001|Participant Flow|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
11201066|NCT02198040|FG002|Participant Flow|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
11242730|NCT02498236|FG001|Participant Flow|12IU Oxytocin|Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11201067|NCT02198040|OG000|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
11201068|NCT02198040|OG001|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
11201069|NCT02198040|OG002|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
11201070|NCT02198040|OG000|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.~10"
11201071|NCT02198040|OG001|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
11201072|NCT02198040|EG000|Reported Event|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
11202356|NCT02207244|OG001|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
11242731|NCT02498236|FG002|Participant Flow|24IU Oxytocin|Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11201073|NCT02198040|EG001|Reported Event|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
11242732|NCT02498236|FG003|Participant Flow|36IU Oxytocin|Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10850355|NCT00302068|EG002|Reported Event|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
10800353|NCT01751906|FG000|Participant Flow|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800354|NCT01751906|FG001|Participant Flow|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800355|NCT01751906|OG000|Outcome|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800356|NCT01751906|OG001|Outcome|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800357|NCT01751906|EG000|Reported Event|Absorb BVS|"Subjects receiving Absorb BVS~Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800358|NCT01751906|EG001|Reported Event|XIENCE|"Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition~XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
10800359|NCT01665144|BG000|Baseline|Siponimod (BAF312)|Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on 2 mg BAF312 daily for a variable duration.
10800360|NCT01665144|BG001|Baseline|Placebo|Matching placebo to BAF312 was administered orally during the Core Part of the trial.
10800361|NCT01665144|BG002|Baseline|Total|Total of all reporting groups
10800362|NCT01665144|FG000|Participant Flow|Siponimod (BAF312)|Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on 2 mg BAF312 daily for a variable duration.
10800363|NCT01665144|FG001|Participant Flow|Placebo|Matching placebo to BAF312 was administered orally during the Core Part of the trial.
10800364|NCT01665144|OG000|Outcome|Siponimod (BAF312)|Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on 2 mg BAF312 daily for a variable duration.
10800365|NCT01665144|OG001|Outcome|Placebo|Matching placebo to BAF312 was administered orally during the Core Part of the trial.
10800366|NCT01665144|EG000|Reported Event|Siponimod (BAF312)|Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on 2 mg BAF312 daily for a variable duration.
11201074|NCT02198040|EG002|Reported Event|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
11201075|NCT02198235|BG000|Baseline|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
11201076|NCT02198235|BG001|Baseline|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201077|NCT02198235|BG002|Baseline|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201078|NCT02198235|BG003|Baseline|Total|Total of all reporting groups
11201079|NCT02198235|FG000|Participant Flow|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
11201080|NCT02198235|FG001|Participant Flow|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201081|NCT02198235|FG002|Participant Flow|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201082|NCT02198235|OG000|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
10800367|NCT01665144|EG001|Reported Event|Placebo|Matching placebo to BAF312 was administered orally during the Core Part of the trial.
11201083|NCT02198235|OG001|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201084|NCT02198235|OG002|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201085|NCT02198235|EG000|Reported Event|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
11201086|NCT02198235|EG001|Reported Event|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201087|NCT02198235|EG002|Reported Event|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
11201088|NCT02198430|BG000|Baseline|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
11201089|NCT02198430|BG001|Baseline|Control Group|Children without hemophilia
11201090|NCT02198430|BG002|Baseline|Total|Total of all reporting groups
10850356|NCT00302081|BG000|Baseline|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
10850357|NCT00302081|BG001|Baseline|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
11201091|NCT02198430|FG000|Participant Flow|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
11201092|NCT02198430|FG001|Participant Flow|Control Group|Children without hemophilia
11201093|NCT02198430|OG000|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
11201094|NCT02198430|OG001|Outcome|Control Group|Children without hemophilia
11201095|NCT02198430|EG000|Reported Event|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
11201096|NCT02198430|EG001|Reported Event|Control Group|Children without hemophilia
11201097|NCT02198651|BG000|Baseline|Adalimumab 40 mg Eow|40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)
11201098|NCT02198651|FG000|Participant Flow|Adalimumab 40 mg Eow|40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)
11201099|NCT02198651|FG001|Participant Flow|Adalimumab Tapering|40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
11201100|NCT02198651|FG002|Participant Flow|Adalimumab Withdrawal Arm|Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
11201101|NCT02198651|FG003|Participant Flow|Adalimumab Tapering to Rescue Arm|40 mg adalimumab administered subcutaneously every other week (eow) from Flare Week 0 to Flare Week 16 (Open-Label Rescue Period)
11201102|NCT02198651|FG004|Participant Flow|Adalimumab Withdrawal to Rescue Arm|40 mg adalimumab administered subcutaneously every other week (eow) from Flare Week 0 to Flare Week 16 (Open-Label Rescue Period)
11201103|NCT02198651|OG000|Outcome|Adalimumab Tapering|40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
11201104|NCT02198651|OG001|Outcome|Adalimumab Withdrawal Arm|Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
11201105|NCT02198651|OG000|Outcome|Flared Participants|Participants who experienced flare during the Double-blind Period
11201106|NCT02198651|OG001|Outcome|Non-Flared Participants|Participants who did not experience flare during the Double-blind Period
11201107|NCT02198651|OG000|Outcome|DAS28 (ESR) < 2.6|Disease Activity Score 28 (DAS28 ESR) < 2.6
11201108|NCT02198651|OG001|Outcome|SDAI ≤ 3.3|Simplified Disease Activity Index (SDAI) score ≤ 3.3
11201109|NCT02198651|OG002|Outcome|CDAI ≤ 2.8|Clinical Disease Activity Index (CDAI) score ≤ 2.8
11201110|NCT02198651|EG000|Reported Event|Adalimumab 40 mg Eow|40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4
11201111|NCT02198651|EG001|Reported Event|Adalimumab Tapering|40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
11201112|NCT02198651|EG002|Reported Event|Adalimumab Withdrawal Arm|Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
10800368|NCT01551550|BG000|Baseline|GDD & Amniotic Membrane Graft|"After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed."
10850358|NCT00302081|BG002|Baseline|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
10850359|NCT00302081|BG003|Baseline|Total|Total of all reporting groups
11201113|NCT02198651|EG003|Reported Event|Adalimumab 40 mg Eow Rescue Arm|40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)
11201114|NCT02198664|BG000|Baseline|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201115|NCT02198664|BG001|Baseline|ARC001 AR101 Group|"Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201116|NCT02198664|BG002|Baseline|Total|Total of all reporting groups
11201117|NCT02198664|FG000|Participant Flow|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201118|NCT02198664|FG001|Participant Flow|ARC001 AR101 Group|"Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201119|NCT02198664|OG000|Outcome|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11242733|NCT02498236|FG004|Participant Flow|48IU Oxytocin|Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242734|NCT02498236|FG005|Participant Flow|60IU Oxytocin|Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242735|NCT02498236|FG006|Participant Flow|72IU Oxytocin|Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10850360|NCT00302081|FG000|Participant Flow|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
11201120|NCT02198664|OG001|Outcome|ARC001 AR101 Group|"Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201121|NCT02198664|OG000|Outcome|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg"
11201122|NCT02198664|OG000|Outcome|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)."
11201123|NCT02198664|EG000|Reported Event|ARC001 Placebo Group|"Subjects who received placebo in study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201124|NCT02198664|EG001|Reported Event|ARC001 AR101 Group|"Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.~AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)"
11201125|NCT02198963|BG000|Baseline|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
11201126|NCT02198963|FG000|Participant Flow|RUT058-60 vs Negative Control vs Positive Control|Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
10850361|NCT00302081|FG001|Participant Flow|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
11201127|NCT02198963|OG000|Outcome|Hypochlorous Acid Solution 106 mg/L-Abraded|0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
11201128|NCT02198963|OG001|Outcome|Sodium Lauryl Sulfate (0.1%) -Abraded|0.02 mL of the Positive Control applied to abraded skin sites.
11201129|NCT02198963|OG002|Outcome|Physiological Saline (0.9%), USP-Abraded|0.02 mL of the Negative Control applied to abraded skin sites.
11201130|NCT02198963|OG003|Outcome|Hypochlorous Acid Solution 106 mg/L- Non-Abraded|0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
11201131|NCT02198963|OG004|Outcome|Sodium Lauryl Sulfate (0.1%)- Non-Abraded|0.02 mL of the Positive Control applied to non-abraded skin sites.
11201132|NCT02198963|OG005|Outcome|Physiological Saline (0.9%), USP- Non-Abraded|0.02 mL of the Negative Control applied to non-abraded skin sites.
11201133|NCT02198963|EG000|Reported Event|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
11201134|NCT02199028|BG000|Baseline|Hylenex, Then Control|"Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.~On weeks 1 and 3 (control weeks) no Hylenex was administered.~On weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear."
11201135|NCT02199028|BG001|Baseline|Control, Then Hylenex|"Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.~On weeks 1 and 3 (control weeks) no Hylenex was administered.~On weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear."
11201136|NCT02199028|BG002|Baseline|Total|Total of all reporting groups
11201137|NCT02199028|FG000|Participant Flow|Hylenex, Then Control|"Participants assigned to active treatment arm (Hylenex) for weeks 1 and 3.~On weeks 1 and 3 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.~On weeks 2 and 4 (control weeks) no Hylenex was administered."
11201138|NCT02199028|FG001|Participant Flow|Control, Then Hylenex|"Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.~On weeks 1 and 3 (control weeks) no Hylenex was administered.~On weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear."
11242736|NCT02498236|FG007|Participant Flow|84IU Oxytocin|Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242737|NCT02498236|OG000|Outcome|8IU Oxytocin|8 international units (IU) of Oxytocin
11242738|NCT02498236|OG001|Outcome|12IU Oxytocin|12 international units (IU) of Oxytocin
11242739|NCT02498236|OG002|Outcome|24IU Oxytocin|24 international units (IU) of Oxytocin
11242740|NCT02498236|OG003|Outcome|36IU Oxytocin|36 international units (IU) of Oxytocin
11242741|NCT02498236|OG004|Outcome|48IU Oxytocin|48 international units (IU) of Oxytocin
11242742|NCT02498236|OG005|Outcome|60IU Oxytocin|60 international units (IU) of Oxytocin
11242743|NCT02498236|OG006|Outcome|72IU Oxytocin|72 international units (IU) of Oxytocin
11242744|NCT02498236|OG007|Outcome|84IU Oxytocin|84 international units (IU) of Oxytocin
11242745|NCT02498236|OG008|Outcome|Placebo|Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received.
11242746|NCT02498236|OG008|Outcome|Placebo|Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of OT they received.
11242747|NCT02498236|EG000|Reported Event|8IU Oxytocin|Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11201139|NCT02199028|OG000|Outcome|Hyaluronidase|"Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3~Hyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase."
11201140|NCT02199028|OG001|Outcome|Control|Subjects will not receive Hyaluronidase during this week
10850362|NCT00302081|FG002|Participant Flow|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
11242748|NCT02498236|EG001|Reported Event|12IU Oxytocin|Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242749|NCT02498236|EG002|Reported Event|24IU Oxytocin|Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
11242750|NCT02498236|EG003|Reported Event|36IU Oxytocin|Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10800369|NCT01551550|BG001|Baseline|GDD & Pericardial Graft|"After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed."
10800370|NCT01551550|BG002|Baseline|Total|Total of all reporting groups
10800371|NCT01551550|FG000|Participant Flow|GDD & Amniotic Membrane Graft|"After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed."
10850363|NCT00302081|OG000|Outcome|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
10850364|NCT00302081|OG001|Outcome|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
10850365|NCT00302081|OG002|Outcome|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
10850366|NCT00302081|EG000|Reported Event|PEG2b 1.5/R*(24 Weeks)|
10850367|NCT00302081|EG001|Reported Event|PEG2b 1.0/R*(24 Weeks)|
11242751|NCT02498236|EG004|Reported Event|48IU Oxytocin|Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10800372|NCT01551550|FG001|Participant Flow|GDD & Pericardial Graft|"After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed."
10850368|NCT00302081|EG002|Reported Event|PEG2b 1.5/R*(16 Weeks)|
10850369|NCT00302107|BG000|Baseline|Mirtazapine|Mirtazapine up to 45 mg/qhs as tolerated
10850370|NCT00302107|BG001|Baseline|Placebo|Placebo up to three tablets qhs
11242752|NCT02498236|EG005|Reported Event|60IU Oxytocin|Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10850371|NCT00302107|BG002|Baseline|Total|Total of all reporting groups
10850372|NCT00302107|FG000|Participant Flow|Mirtazapine|Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
11242753|NCT02498236|EG006|Reported Event|72IU Oxytocin|Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10800373|NCT01551550|OG000|Outcome|GDD & Amniotic Membrane Graft|"After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed."
11242754|NCT02498236|EG007|Reported Event|84IU Oxytocin|Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
10850373|NCT00302107|FG001|Participant Flow|Placebo|Placebo up to three pills qhs
10850374|NCT00302107|OG000|Outcome|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
10850375|NCT00302107|OG001|Outcome|Placebo|Placebo up to 3 tablets qhs
10850376|NCT00302107|EG000|Reported Event|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
10966277|NCT00886483|EG000|Reported Event|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
10966278|NCT00886483|EG001|Reported Event|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
10966279|NCT00886587|BG000|Baseline|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966280|NCT00886587|BG001|Baseline|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966281|NCT00886587|BG002|Baseline|Total|Total of all reporting groups
10966282|NCT00886587|FG000|Participant Flow|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966283|NCT00886587|FG001|Participant Flow|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
11242755|NCT02498236|EG008|Reported Event|Placebo|Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received.
10966284|NCT00886587|OG000|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966285|NCT00886587|OG001|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966286|NCT00886587|EG000|Reported Event|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966287|NCT00886587|EG001|Reported Event|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
10966288|NCT00886613|BG000|Baseline|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
10966289|NCT00886613|BG001|Baseline|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
11242756|NCT02498418|BG000|Baseline|Generic Rifaximin 200 mg Tablets|Participants received a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.
11242757|NCT02498418|BG001|Baseline|Xifaxan 200 mg Tablets|Participants received a xifaxan 200 mg tablet 3 times daily orally for 3 days.
10850377|NCT00302107|EG001|Reported Event|Placebo|Placebo up to 3 tablets qhs
10850378|NCT00302133|BG000|Baseline|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
11242758|NCT02498418|BG002|Baseline|Rifaximin Placebo Tablets|Participants received a rifaximin placebo tablet 3 times daily orally for 3 days.
10850379|NCT00302133|BG001|Baseline|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
11242759|NCT02498418|BG003|Baseline|Total|Total of all reporting groups
11242760|NCT02498418|FG000|Participant Flow|Generic Rifaximin 200 mg Tablets|Participants received a generic rifaximin 200 milligrams (mg) tablet 3 times daily orally for 3 days.
11242761|NCT02498418|FG001|Participant Flow|Xifaxan 200 mg Tablets|Participants received a xifaxan 200 mg tablet 3 times daily orally for 3 days.
11242762|NCT02498418|FG002|Participant Flow|Rifaximin Placebo Tablets|Participants received a rifaximin placebo tablet 3 times daily orally for 3 days.
10850380|NCT00302133|BG002|Baseline|Total|Total of all reporting groups
10850381|NCT00302133|FG000|Participant Flow|Naltrexone|"Naltrexone add on to valproate open label~Naltrexone Hydrochloride 50 mg daily for 12 weeks"
10850382|NCT00302133|FG001|Participant Flow|Placebo|"Placebo add on to valproate open label~Placebo one capsule daily for 12 weeks"
10850383|NCT00302133|OG000|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
10850384|NCT00302133|OG001|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
10850385|NCT00302133|EG000|Reported Event|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
10800374|NCT01551550|OG001|Outcome|GDD & Pericardial Graft|"After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed."
11201141|NCT02199028|OG000|Outcome|Hyaluronidase Injections|"Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3~Hyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase."
11242763|NCT02498418|OG000|Outcome|Generic Rifaximin 200 mg Tablets|Participants received a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.
11242764|NCT02498418|OG001|Outcome|Xifaxan 200 mg Tablets|Participants received a xifaxan 200 mg tablet 3 times daily orally for 3 days.
10850386|NCT00302133|EG001|Reported Event|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
10966290|NCT00886613|BG002|Baseline|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
10966291|NCT00886613|BG003|Baseline|Total|Total of all reporting groups
10966292|NCT00886613|FG000|Participant Flow|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
10966293|NCT00886613|FG001|Participant Flow|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
10966294|NCT00886613|FG002|Participant Flow|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
11242765|NCT02498418|OG002|Outcome|Rifaximin Placebo Tablets|Participants received a rifaximin placebo tablet 3 times daily orally for 3 days.
11242766|NCT02498418|EG000|Reported Event|Generic Rifaximin 200 mg Tablets|Participants received a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.
11242767|NCT02498418|EG001|Reported Event|Xifaxan 200 mg Tablets|Participants received a xifaxan 200 mg tablet 3 times daily orally for 3 days.
10966295|NCT00886613|OG000|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
11242768|NCT02498418|EG002|Reported Event|Rifaximin Placebo Tablets|Participants received a rifaximin placebo tablet 3 times daily orally for 3 days.
11242769|NCT02498483|BG000|Baseline|Treatment Arm|Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
11242770|NCT02498483|BG001|Baseline|Control Arm|Includes subjects who received routine care post circumcision.
10966296|NCT00886613|OG000|Outcome|Part A Participants - VZV Skin Reaction (48 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 48 hours.
11242771|NCT02498483|BG002|Baseline|Total|Total of all reporting groups
11242772|NCT02498483|FG000|Participant Flow|Treatment Arm|Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
11242773|NCT02498483|FG001|Participant Flow|Control Arm|Includes subjects who received routine care post circumcision.
11242774|NCT02498483|OG000|Outcome|Acetaminophen Arm|"Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.~Acetaminophen: Infants will receive 15 mg/kg of acetaminophen."
10966297|NCT00886613|OG001|Outcome|Part A Participants - VZV Skin Reaction (72 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 72 hours.
11242775|NCT02498483|OG001|Outcome|Non-treatment Arm|Routine circumcision without acetaminophen.
11242776|NCT02498483|EG000|Reported Event|Acetaminophen Arm|Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
10966298|NCT00886613|OG000|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
11242777|NCT02498483|EG001|Reported Event|Non-treatment Arm|Routine circumcision without acetaminophen.
10966299|NCT00886613|OG001|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
10966300|NCT00886613|OG002|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
11201142|NCT02199028|EG000|Reported Event|Hyaluronidase Week|"Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3~Hyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase."
11201143|NCT02199028|EG001|Reported Event|Control Week|Subjects will not receive Hyaluronidase during this week
11242778|NCT02498522|BG000|Baseline|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
10966301|NCT00886613|EG000|Reported Event|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
10966302|NCT00886613|EG001|Reported Event|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
11201144|NCT02199041|BG000|Baseline|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
11201145|NCT02199041|FG000|Participant Flow|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, granulocyte colony-stimulating factor (G-CSF), mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
11201146|NCT02199041|OG000|Outcome|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
11201147|NCT02199041|EG000|Reported Event|Treatment|"Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions.~Cells for infusion are prepared using the CliniMACS System.~Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil."
11201148|NCT02199041|EG001|Reported Event|Blood Donors|Blood donors were enrolled on the study to provide cells for transplantation used in the Treatment Arm.
11201149|NCT02199080|BG000|Baseline|Atrial Fibrillation|"D-dimer assay before ablation of atrial fibrillation~D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement"
11201150|NCT02199080|FG000|Participant Flow|Atrial Fibrillation|"D-dimer assay before ablation of atrial fibrillation~D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement"
11201151|NCT02199080|OG000|Outcome|Atrial Fibrillation|"D-dimer assay before ablation of atrial fibrillation~D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement"
11201152|NCT02199080|OG000|Outcome|Atrial Thrombus|Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
11201153|NCT02199080|OG001|Outcome|No Atrial Thrombus|Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
11201154|NCT02199080|EG000|Reported Event|Atrial Fibrillation|D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
11201155|NCT02199197|BG000|Baseline|Radium Ra 223 Dichloride and Enzalutamide|"Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.~Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kBq/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201156|NCT02199197|BG001|Baseline|Enzalutamide Alone|"Enzalutamide administered as a single agent for 6 28-day cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201157|NCT02199197|BG002|Baseline|Total|Total of all reporting groups
11201158|NCT02199197|FG000|Participant Flow|Radium Ra 223 Dichloride and Enzalutamide|"Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.~Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kilobecquerel (kBq)/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201159|NCT02199197|FG001|Participant Flow|Enzalutamide Alone|"Enzalutamide administered as a single agent for 6 28-day cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201160|NCT02199197|OG000|Outcome|Radium Ra 223 Dichloride and Enzalutamide|"Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.~Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kBq/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201161|NCT02199197|OG001|Outcome|Enzalutamide Alone|"Enzalutamide administered as a single agent for 6 28-day cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201162|NCT02199197|OG000|Outcome|Radium Ra 223 Dichloride and Enzalutamide|"Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.~Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kilobecquerel (kBq)/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201163|NCT02199197|EG000|Reported Event|Radium Ra 223 Dichloride and Enzalutamide|"Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.~Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kBq/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201164|NCT02199197|EG001|Reported Event|Enzalutamide Alone|"Enzalutamide administered as a single agent for 6 28-day cycles.~Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles."
11201165|NCT02199314|BG000|Baseline|Desflurane MEP's|Transcranial motor evoked potentials are obtained under propofol/remifentanil TIVA anesthesia and the again under TIVA plus desflurane 3%, after desflurane has been on for at least 5 minutes, at two different time points; before incision and at the end of the procedure. Each patient is his/her own control
11201166|NCT02199314|FG000|Participant Flow|MEPs Pre and Post Desflurane at 2 Time Points|Transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure
11201167|NCT02199314|OG000|Outcome|MEPs Pre and Post Desflurane at 2 Time Points|A series of 15 transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure. The series consisted of 3 runs of 5,6, 7, 8, and 9 pulse trains, each train separated by 30 seconds. The 3 runs were averaged to give and average value of TcMEP amplitude and area for the 5,6,7,8 and 9 pulse trains. The data were used to compute regression coefficients for area vs pulse length for the TIVA case and TIVA plus desflurane for each participant who completed the study..
11201168|NCT02199314|EG000|Reported Event|Desflurane MEP's|"Transcranial motor evoked potentials are obtained under TIVA and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control~Desflurane"
11201169|NCT02199496|BG000|Baseline|Cohort 1: Ustekinumab-Single-dose Phase 1, Multi-dose Phase 2|Subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously then re-enrolled into the multi-dose phase. In multi-dose phase, subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously followed by every 8 week maintenance doses of 90 mg Stelara (ustekinumab) subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201170|NCT02199496|BG001|Baseline|Cohort 2: Ustekinumab-Multi-dose Phase 2|Subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously followed by every 8 week maintenance doses of 90 mg Stelara (ustekinumab) subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201171|NCT02199496|BG002|Baseline|Total|Total of all reporting groups
11201172|NCT02199496|FG000|Participant Flow|Cohort 1: Single-dose Phase 1, Multi-dose Phase 2|Subjects given single dose of 270mg Ustekinumab subcutaneously then re-enrolled into the multi-dose phase. In multi-dose phase subjects given single dose of 270mg Ustekinumab subcutaneously with follow up treatment doses of 90 mg (1 dose of 90 mg) at week 8, week 16, week 24, week 32, and week 40
11201173|NCT02199496|FG001|Participant Flow|Cohort 2: Multi-Dose Ustekinumab Phase 2|Subjects given single dose of 270mg Ustekinumab subcutaneously then follow up treatment doses of 90 mg (1 dose of 90 mg) at week 8, week 16, week 24, week 32, and week 40
11201174|NCT02199496|OG000|Outcome|Cohort 1: Ustekinumab-Single Dose Phase 1|Single dose of 270mg ustekinumab subcutaneously
11201175|NCT02199496|OG000|Outcome|Cohort 1: Ustekinumab-Multi-dose Phase 2|Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201176|NCT02199496|OG000|Outcome|Cohort 2: Ustekinumab-Multi-dose Phase 2|Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201177|NCT02199496|EG000|Reported Event|Cohort 1: Ustekinumab-Single Dose Phase 1|Single dose of 270mg ustekinumab subcutaneously
11201178|NCT02199496|EG001|Reported Event|Cohort 1: Ustekinumab-Multi-dose Phase 2|Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201179|NCT02199496|EG002|Reported Event|Cohort 2: Ustekinumab-Multi-dose Phase 2|Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
11201180|NCT02199509|BG000|Baseline|Primary Oromandibular Dystonia or Cranial Dystonia|All participants enrolled in the study.
11201181|NCT02199509|FG000|Participant Flow|Levetiracetam Then Placebo Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Levetiracetam at maximum tolerated dose for three weeks followed by a Placebo.
10966303|NCT00886613|EG002|Reported Event|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
11201182|NCT02199509|FG001|Participant Flow|Placebo Then Levetiracetam Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Placebo for maximum dose for three weeks followed by Levetiracetam.
11242779|NCT02498522|BG001|Baseline|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11202357|NCT02207244|OG000|Outcome|Withdrawal Group|Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 48 until loss of >=50% in the improvement in PASI.
11242780|NCT02498522|BG002|Baseline|Total|Total of all reporting groups
10966304|NCT00886626|BG000|Baseline|All Participants|All enrolled participants
11242781|NCT02498522|FG000|Participant Flow|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242782|NCT02498522|FG001|Participant Flow|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242783|NCT02498522|OG000|Outcome|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242784|NCT02498522|OG001|Outcome|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242785|NCT02498522|EG000|Reported Event|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242786|NCT02498522|EG001|Reported Event|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
11242787|NCT02498652|BG000|Baseline|Cohort 1|Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
11242788|NCT02498652|BG001|Baseline|Cohort 2|Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
11242789|NCT02498652|BG002|Baseline|Total|Total of all reporting groups
11242790|NCT02498652|FG000|Participant Flow|Cohort 1|Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
11242791|NCT02498652|FG001|Participant Flow|Cohort 2|Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
11242792|NCT02498652|OG000|Outcome|Treatment A1|Allopurinol 300 mg qd
11242793|NCT02498652|OG001|Outcome|Treatment A2q|Allopurinol 600 mg qd
11242794|NCT02498652|OG002|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid)
11242795|NCT02498652|OG003|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
11242796|NCT02498652|OG004|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
11242797|NCT02498652|OG005|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd
11242798|NCT02498652|OG003|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd
10966305|NCT00886626|FG000|Participant Flow|Exenatide Then Control|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
11242799|NCT02498652|OG004|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd
11242800|NCT02498652|OG005|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd
11242801|NCT02498652|OG000|Outcome|Treatment A1|Allopurinol 300 mg qd (Cohorts 1 and 2)
11242802|NCT02498652|OG001|Outcome|Treatment A2q|Allopurinol 600 mg (qd) (Cohorts 1 and 2)
11242803|NCT02498652|OG002|Outcome|Treatment A2b|Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
11242804|NCT02498652|OG003|Outcome|Treatment R1|Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
11242805|NCT02498652|OG004|Outcome|Treatment R2|Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
11242806|NCT02498652|OG005|Outcome|Treatment R3|Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
11242807|NCT02498652|OG006|Outcome|Treatment R4|Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
11242808|NCT02498652|OG007|Outcome|Treatment R5|Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
11242809|NCT02498652|OG008|Outcome|Treatment R6|Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
11242810|NCT02498652|OG000|Outcome|Cohort 1|RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
11242811|NCT02498652|OG001|Outcome|Cohort 2|RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
11242812|NCT02498652|EG000|Reported Event|Cohort 1|RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
11242813|NCT02498652|EG001|Reported Event|Cohort 2|RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
11242814|NCT02498678|BG000|Baseline|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
11242815|NCT02498678|BG001|Baseline|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
11242816|NCT02498678|BG002|Baseline|Total|Total of all reporting groups
11242817|NCT02498678|FG000|Participant Flow|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
11342711|NCT03714256|BG000|Baseline|Children 6-17 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342712|NCT03714256|BG001|Baseline|Children 18 - 36 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342713|NCT03714256|BG002|Baseline|Total|Total of all reporting groups
11242818|NCT02498678|FG001|Participant Flow|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
10966306|NCT00886626|FG001|Participant Flow|Control Then Exenatide|No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
10966307|NCT00886626|OG000|Outcome|Exenatide|Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
10966308|NCT00886626|OG001|Outcome|Control|No medication control for 3-months. Participants came from period 1 and period 2.
10966309|NCT00886626|EG000|Reported Event|Exenatide|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
11242819|NCT02498678|OG000|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
11201183|NCT02199509|OG000|Outcome|Levetiracetam Group|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201184|NCT02199509|OG001|Outcome|Placebo Group|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201185|NCT02199509|OG000|Outcome|Levetiracetam Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201186|NCT02199509|OG001|Outcome|Levetiracetam Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201187|NCT02199509|OG002|Outcome|Placebo Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201188|NCT02199509|OG003|Outcome|Placebo Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11201189|NCT02199509|EG000|Reported Event|Levetiracetam|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
11242820|NCT02498678|OG001|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
10966310|NCT00886626|EG001|Reported Event|Control|No medication control for 3-months.
10966311|NCT00886639|BG000|Baseline|6MWT With Different Gas Mixtures|
10966312|NCT00886639|FG000|Participant Flow|6MWT With Different Gas Mixtures|
10966313|NCT00886639|OG000|Outcome|Oxygen Response|difference between 6-minute-walking test on oxygen and on medical air
10966314|NCT00886639|EG000|Reported Event|6MWT With Different Gas Mixtures|
10966315|NCT00886704|BG000|Baseline|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
10966316|NCT00886704|BG001|Baseline|Convenience Drink Without EPA and DHA|
10966317|NCT00886704|BG002|Baseline|Total|Total of all reporting groups
10966318|NCT00886704|FG000|Participant Flow|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
10966319|NCT00886704|FG001|Participant Flow|Convenience Drink Without EPA and DHA|
10966320|NCT00886704|OG000|Outcome|Convenience Drink With EPA and DHA|Palatability
11201190|NCT02199509|EG001|Reported Event|Placebo|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
10800375|NCT01551550|EG000|Reported Event|GDD & Amniotic Membrane Graft|"After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed."
10800376|NCT01551550|EG001|Reported Event|GDD & Pericardial Graft|"After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.~GDD: The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.~Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed."
10850387|NCT00302159|BG000|Baseline|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
10966321|NCT00886704|OG001|Outcome|Convenience Drink Without EPA and DHA|Palatability
11342714|NCT03714256|FG000|Participant Flow|Children 6-17 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342715|NCT03714256|FG001|Participant Flow|Children 18 - 36 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
10966322|NCT00886704|OG000|Outcome|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
11342716|NCT03714256|OG000|Outcome|Children 6-17 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342717|NCT03714256|OG001|Outcome|Children 18 - 36 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342718|NCT03714256|EG000|Reported Event|Children 6-17 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342719|NCT03714256|EG001|Reported Event|Children 18 - 36 Months|"Device, patient mobility, powered:~Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.~Device, patient mobility, powered: Pediatric mobility device"
11342720|NCT03714659|BG000|Baseline|Intervention|"Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires.~Lipogems: Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint."
11342721|NCT03714659|FG000|Participant Flow|Intervention|"Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires.~Lipogems: Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint."
11342722|NCT03714659|OG000|Outcome|Intervention|"Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires.~Lipogems: Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint."
11342723|NCT03714659|EG000|Reported Event|Intervention|"Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires.~Lipogems: Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint."
11342724|NCT03714672|BG000|Baseline|Tramadol/Diclofenac 50/50|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 50 mg/50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 50/50: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342725|NCT03714672|BG001|Baseline|Tramadol/Diclofenac 25/25|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 25 mg/25 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 25/25: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342726|NCT03714672|BG002|Baseline|Tramadol 50|"Participants received 3 doses of tramadol hydrochloride 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol 50: Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were be taken 8 hours apart."
10850388|NCT00302159|FG000|Participant Flow|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
10966323|NCT00886704|OG001|Outcome|Convenience Drink Without EPA and DHA|
10966324|NCT00886704|EG000|Reported Event|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
10966325|NCT00886704|EG001|Reported Event|Convenience Drink Without EPA and DHA|
11342727|NCT03714672|BG003|Baseline|Diclofenac 50|"Participants received 3 doses of diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction~Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were be taken 8 hours apart."
11342728|NCT03714672|BG004|Baseline|Total|Total of all reporting groups
11342729|NCT03714672|FG000|Participant Flow|Tramadol/Diclofenac 50/50|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 50 mg/50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 50/50: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342730|NCT03714672|FG001|Participant Flow|Tramadol/Diclofenac 25/25|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 25 mg/25 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 25/25: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342731|NCT03714672|FG002|Participant Flow|Tramadol 50|"Participants received 3 doses of tramadol hydrochloride 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol 50: Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart."
11342732|NCT03714672|FG003|Participant Flow|Diclofenac 50|"Participants received 3 doses of diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342733|NCT03714672|OG000|Outcome|Tramadol/Diclofenac 50/50|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 50 mg/50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 50/50: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342734|NCT03714672|OG001|Outcome|Tramadol/Diclofenac 25/25|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 25 mg/25 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 25/25: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342735|NCT03714672|OG002|Outcome|Tramadol 50|"Participants received 3 doses of tramadol hydrochloride 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol 50: Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart."
11342736|NCT03714672|OG003|Outcome|Diclofenac 50|"Participants received 3 doses of diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction~Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342737|NCT03714672|OG003|Outcome|Diclofenac 50|"Participants received 3 doses of diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342738|NCT03714672|EG000|Reported Event|Tramadol/Diclofenac 50/50|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 50 mg/50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 50/50: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342739|NCT03714672|EG001|Reported Event|Tramadol/Diclofenac 25/25|"Participants received 3 doses of tramadol hydrochloride/diclofenac sodium 25 mg/25 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol/Diclofenac 25/25: Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342740|NCT03714672|EG002|Reported Event|Tramadol 50|"Participants received 3 doses of tramadol hydrochloride 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Tramadol 50: Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart."
11342741|NCT03714672|EG003|Reported Event|Diclofenac 50|"Participants received 3 doses of diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.~Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart."
11342742|NCT03714919|BG000|Baseline|Non-opiod Pain Relief|"Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.~Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg~Acetaminophen: Preoperative oral acetaminophen 15 mg/kg~Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg~Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg"
11342743|NCT03714919|FG000|Participant Flow|Non-opiod Pain Relief|"Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.~Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg~Acetaminophen: Preoperative oral acetaminophen 15 mg/kg~Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg~Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg"
11342744|NCT03714919|OG000|Outcome|Non-opiod Pain Relief|"Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.~Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg~Acetaminophen: Preoperative oral acetaminophen 15 mg/kg~Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg~Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg"
10966326|NCT00886743|BG000|Baseline|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
10966327|NCT00886743|FG000|Participant Flow|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
10850389|NCT00302159|OG000|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
10966328|NCT00886743|OG000|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
11201191|NCT02199574|BG000|Baseline|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
11201192|NCT02199574|FG000|Participant Flow|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
11201193|NCT02199574|OG000|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: 133 mg EXPAREL in 10 mL."
11342745|NCT03714919|EG000|Reported Event|Non-opiod Pain Relief|"Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.~Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg~Acetaminophen: Preoperative oral acetaminophen 15 mg/kg~Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg~Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg"
11342746|NCT03715426|BG000|Baseline|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
10966329|NCT00886743|EG000|Reported Event|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
11342747|NCT03715426|BG001|Baseline|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11342748|NCT03715426|BG002|Baseline|Total|Total of all reporting groups
11342749|NCT03715426|FG000|Participant Flow|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11342750|NCT03715426|FG001|Participant Flow|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11342751|NCT03715426|OG000|Outcome|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11342752|NCT03715426|OG001|Outcome|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11342753|NCT03715426|EG000|Reported Event|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11342754|NCT03715426|EG001|Reported Event|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11342755|NCT03715452|BG000|Baseline|DyeVert™ Plus Contrast Reduction System|"Dyevert™ Plus Contrast Reduction System~DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient."
10966330|NCT00886769|BG000|Baseline|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
10966331|NCT00886769|BG001|Baseline|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
10966332|NCT00886769|BG002|Baseline|Total|Total of all reporting groups
10850390|NCT00302159|OG000|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
10966333|NCT00886769|FG000|Participant Flow|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
10850391|NCT00302159|EG000|Reported Event|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
10850392|NCT00302211|BG000|Baseline|DB Iloprost 6×/Day|Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
10850393|NCT00302211|BG001|Baseline|DB Iloprost 4×/Day|Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
10850394|NCT00302211|BG002|Baseline|DB Placebo 6×/Day|Inhaled placebo 6×/day plus sildenafil with or without bosentan
10850395|NCT00302211|BG003|Baseline|Total|Total of all reporting groups
10850396|NCT00302211|FG000|Participant Flow|DB Iloprost 6×/Day|Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
10966334|NCT00886769|FG001|Participant Flow|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
11201194|NCT02199574|OG000|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
11201195|NCT02199574|OG000|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
11201196|NCT02199574|EG000|Reported Event|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
11201197|NCT02199652|BG000|Baseline|Placebo|"placebo pill~Placebo"
11201198|NCT02199652|BG001|Baseline|Prazosin|"prazosin pill~Prazosin"
11201199|NCT02199652|BG002|Baseline|Total|Total of all reporting groups
10850397|NCT00302211|FG001|Participant Flow|DB Iloprost 4×/Day|Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
11201200|NCT02199652|FG000|Participant Flow|Placebo|"placebo pill~Placebo"
11201201|NCT02199652|FG001|Participant Flow|Prazosin|"prazosin pill~Prazosin"
11201202|NCT02199652|OG000|Outcome|Placebo|"placebo pill~Placebo"
11201203|NCT02199652|OG001|Outcome|Prazosin|"prazosin pill~Prazosin"
11201204|NCT02199652|EG000|Reported Event|Placebo|"placebo pill~Placebo"
11201205|NCT02199652|EG001|Reported Event|Prazosin|"prazosin pill~Prazosin"
11201206|NCT02199717|BG000|Baseline|Boys With Hemophilia|
11201207|NCT02199717|FG000|Participant Flow|Boys With Hemophilia|Use of accelerometer for 1 week
11201208|NCT02199717|OG000|Outcome|Severe Hemophilia|Severe Hemophilia
11201209|NCT02199717|OG001|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
11201210|NCT02199717|EG000|Reported Event|Severe Hemophilia|
11201211|NCT02199743|BG000|Baseline|Lurasidone|"Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks~Compare to haloperidol and perphenazine groups combined to lurasidone group."
11201212|NCT02199743|BG001|Baseline|Non-Lurasidone|"Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks.~OR Perphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.~Compare haloperidol and perphenazine groups combined to lurasidone."
11201213|NCT02199743|BG002|Baseline|Total|Total of all reporting groups
11201214|NCT02199743|FG000|Participant Flow|Lurasidone|"Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks~This group was compared to the Non-Lurasidone group (with both haloperidol and perphenazine together) in the final analysis."
11201215|NCT02199743|FG001|Participant Flow|Non-Lurasidone|"Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks.~OR Perphenazine 8mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.~Each of these drug groups were treated individually in the study but grouped together into a Non-Lurasidone group for analysis."
11201216|NCT02199743|OG000|Outcome|Lurasidone|"Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks~This group was compared to the Non-Lurasidone group (with both haloperidol and perphenazine together) in the final analysis."
11201217|NCT02199743|OG001|Outcome|Non-Lurasidone|"Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks.~OR Perphenazine 8mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.~Each of these drug groups were treated individually in the study but grouped together into a Non-Lurasidone group for analysis."
11201218|NCT02199743|OG000|Outcome|Lurasidone|"Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks~Compare to haloperidol and perphenazine groups combined to lurasidone group."
11201219|NCT02199743|OG001|Outcome|Non-Lurasidone|"Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks.~OR Perphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.~Compare haloperidol and perphenazine groups combined to lurasidone."
11201220|NCT02199743|EG000|Reported Event|Lurasidone (LUR)|"Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks~Compare lurasidone (LUR) group to haloperidol and perphenazine (NONLUR) group"
11201221|NCT02199743|EG001|Reported Event|NONLUR|"Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks.~OR Perphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.~Compare haloperidol and perphenazine (NONLUR) group to lurasidone (LUR) group."
11201222|NCT02199795|BG000|Baseline|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
11201223|NCT02199795|BG001|Baseline|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
11201224|NCT02199795|BG002|Baseline|Total|Total of all reporting groups
11201225|NCT02199795|FG000|Participant Flow|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
11201226|NCT02199795|FG001|Participant Flow|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
11201227|NCT02199795|OG000|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
11201228|NCT02199795|OG001|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
10850398|NCT00302211|FG002|Participant Flow|DB Placebo 6×/Day|Inhaled placebo 6×/day plus sildenafil with or without bosentan
11242821|NCT02498678|EG000|Reported Event|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10850399|NCT00302211|FG003|Participant Flow|OL Iloprost 6x/Day|The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
10850400|NCT00302211|FG004|Participant Flow|OL Inhaled Iloprost 4x/Day|Subjects in this group received inhaled iloprost (5μg) 4x/day plus sildenafil with or without bosentan during the open-label period
10800377|NCT01372254|BG000|Baseline|Standard Smoking Cessation|"Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10850401|NCT00302211|OG000|Outcome|DB Iloprost 6×/Day|Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
10850402|NCT00302211|OG001|Outcome|DB Iloprost 4×/Day|Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
10850403|NCT00302211|OG002|Outcome|DB Placebo 6×/Day|Inhaled placebo 6×/day plus sildenafil with or without bosentan
10850404|NCT00302211|OG003|Outcome|OL Iloprost 6x/Day|The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
10850405|NCT00302211|OG004|Outcome|OL Iloprost 4x/Day|The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
10850406|NCT00302211|EG000|Reported Event|DB Iloprost 6×/Day|Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
10850407|NCT00302211|EG001|Reported Event|DB Iloprost 4×/Day|Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
10850408|NCT00302211|EG002|Reported Event|DB Placebo 6×/Day|Inhaled placebo 6×/day plus sildenafil with or without bosentan
11201229|NCT02199795|EG000|Reported Event|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.~Contralaterally Controlled Neuromuscular Electrical Stimulation"
11201230|NCT02199795|EG001|Reported Event|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.~Cyclic Neuromuscular Electrical Stimulation"
11201231|NCT02199964|BG000|Baseline|Cyclosporin 0.05% Emulsion|"used in the eye 4 times a day~Cyclosporin 0.05% emulsion: Topical therapy for dry eye"
10849975|NCT00299494|FG003|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the maximum tolerated dose (MTD) determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11201232|NCT02199964|BG001|Baseline|Endura Refresh, Artificial Tears|"Over the Counter artificial tears used in the eye 4 times a day~Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day"
11201233|NCT02199964|BG002|Baseline|Total|Total of all reporting groups
11201234|NCT02199964|FG000|Participant Flow|Cyclosporin 0.05% Emulsion|"used in the eye 4 times a day~Cyclosporin 0.05% emulsion: Topical therapy for dry eye"
11201235|NCT02199964|FG001|Participant Flow|Endura Refresh, Artificial Tears|"Over the Counter artificial tears used in the eye 4 times a day~Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day"
11201236|NCT02199964|OG000|Outcome|Cyclosporin 0.05% Emulsion|"used in the eye 4 times a day~Cyclosporin 0.05% emulsion: Topical therapy for dry eye"
11201237|NCT02199964|OG001|Outcome|Endura Refresh, Artificial Tears|"Over the Counter artificial tears used in the eye 4 times a day~Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day"
10850409|NCT00302211|EG003|Reported Event|OL Iloprost 6x/Day|The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
10850410|NCT00302211|EG004|Reported Event|OL Iloprost 4x/Day|The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
10850411|NCT00302328|BG000|Baseline|no Peeling|no peeling used
10850412|NCT00302328|BG001|Baseline|ICG Peeling|indocyanine green (ICG) peeling
10800378|NCT01372254|BG001|Baseline|BA for Substance Abusing Smokers|"The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800379|NCT01372254|BG002|Baseline|Total|Total of all reporting groups
10800380|NCT01372254|FG000|Participant Flow|Standard Smoking Cessation|"Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800381|NCT01372254|FG001|Participant Flow|BA for Substance Abusing Smokers|"The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800382|NCT01372254|OG000|Outcome|Standard Smoking Cessation|"Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800383|NCT01372254|OG001|Outcome|BA for Substance Abusing Smokers|"The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800384|NCT01372254|EG000|Reported Event|Standard Smoking Cessation|"Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800385|NCT01372254|EG001|Reported Event|BA for Substance Abusing Smokers|"The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch."
10800386|NCT01351766|BG000|Baseline|Behavioral Activation for Smoking|"Behavioral Activation for Smoking (BATSY) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also be provided 8 weeks of the transdermal nicotine patch.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level."
10800387|NCT01351766|FG000|Participant Flow|Behavioral Activation for Smoking|"Eight, 60-minute group sessions over an 8 week period~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended"
10800388|NCT01351766|OG000|Outcome|Behavioral Activation for Smoking|"Eight, 60-minute group sessions over an 8 week period~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended"
10800389|NCT01351766|EG000|Reported Event|Behavioral Activation for Smoking|"Eight, 60-minute group sessions over an 8 week period~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended"
10850413|NCT00302328|BG002|Baseline|tb Peeling|trypan blue (tb) peeling
10850414|NCT00302328|BG003|Baseline|Total|Total of all reporting groups
11201238|NCT02199964|EG000|Reported Event|Cyclosporin 0.05% Emulsion|"used in the eye 4 times a day~Cyclosporin 0.05% emulsion: Topical therapy for dry eye"
10850415|NCT00302328|FG000|Participant Flow|no Peeling|no peeling used
11201239|NCT02199964|EG001|Reported Event|Endura Refresh, Artificial Tears|"Over the Counter artificial tears used in the eye 4 times a day~Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day"
11201240|NCT02200055|BG000|Baseline|Bioimpedance Assessment|"The only group will be those patients having major intra-abdominal surgical procedures.~Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment~Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment"
11201241|NCT02200055|FG000|Participant Flow|Bioimpedance Assessment|"The only group will be those patients having major intra-abdominal surgical procedures.~Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment~Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment"
11201242|NCT02200055|OG000|Outcome|Bioimpedance Assessment|There are no groups for this study
11201243|NCT02200055|OG000|Outcome|Bioimpedance Assessment|There are no groups in this study
11201244|NCT02200055|OG000|Outcome|Bioimpedance Assessment|"The only group will be those patients having major intra-abdominal surgical procedures.~Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment~Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment"
11201245|NCT02200055|EG000|Reported Event|Bioimpedance Assessment|"The only group will be those patients having major intra-abdominal surgical procedures.~Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment~Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.~Bioimpedance Assessment"
11201246|NCT02200211|BG000|Baseline|Binocular Treatment Younger Cohort (5 to <13 Years)|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201247|NCT02200211|BG001|Baseline|Patching Treatment Younger Cohort (5 to <13 Years)|"Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
11201248|NCT02200211|BG002|Baseline|Binocular Treatment Older Cohort (13 to <17 Years)|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201249|NCT02200211|BG003|Baseline|Patching Treatment Older Cohort (13 to <17 Years)|"Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
11201250|NCT02200211|BG004|Baseline|Total|Total of all reporting groups
11201251|NCT02200211|FG000|Participant Flow|Binocular Treatment Younger|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201252|NCT02200211|FG001|Participant Flow|Patching Treatment Younger|Patching 2 hours per day, 7 days per week
11201253|NCT02200211|FG002|Participant Flow|Binocular Treatment Older|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201254|NCT02200211|FG003|Participant Flow|Patching Treatment Older|Patching 2 hours per day, 7 days per week
10850416|NCT00302328|FG001|Participant Flow|ICG Peeling|indocyanine (ICG) peeling
10850417|NCT00302328|FG002|Participant Flow|tb Peeling|trypan blue (tb) peeling
11201255|NCT02200211|OG000|Outcome|Binocular Treatment Younger|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201256|NCT02200211|OG001|Outcome|Patching Treatment Younger|"Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
11201257|NCT02200211|OG000|Outcome|Binocular Treatment Older|"Age 13 to <17~Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201258|NCT02200211|OG001|Outcome|Patching Treatment Older|"Age 13 to <17~Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
11201259|NCT02200211|OG001|Outcome|Patching Treatment Younger|Patching 2 hours per day, 7 days per week
11201260|NCT02200211|OG002|Outcome|Binocular Treatment Older Cohort|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201261|NCT02200211|OG003|Outcome|Patching Treatment Older|Patching 2 hours per day, 7 days per week
11201262|NCT02200211|OG002|Outcome|Binocular Treatment Older|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201263|NCT02200211|OG003|Outcome|Patching Treatment Older Cohort|Patching 2 hours per day, 7 days per week
11201264|NCT02200211|OG000|Outcome|Binocular Treatment Older Cohort|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201265|NCT02200211|OG001|Outcome|Patching Treatment Older Cohort|Patching 2 hours per day, 7 days per week
11201266|NCT02200211|OG001|Outcome|Binocular Treatment Older Cohort|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
10850418|NCT00302328|OG000|Outcome|no Peeling|Vitrectomy without peeling
11341076|NCT03674281|EG001|Reported Event|Older Adults: CLC|"CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341077|NCT03674281|EG002|Reported Event|Younger Children: SAP|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~e 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6)."
11341078|NCT03674281|EG003|Reported Event|Younger Children: CLC|"CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341079|NCT03674970|BG000|Baseline|Random Nicotine Delivery|"One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341080|NCT03674970|BG001|Baseline|Steady State Nicotine Delivery|"One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341081|NCT03674970|BG002|Baseline|Placebo Control|"One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341082|NCT03674970|BG003|Baseline|Total|Total of all reporting groups
11341083|NCT03674970|FG000|Participant Flow|Random Nicotine Delivery|"One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341084|NCT03674970|FG001|Participant Flow|Steady State Nicotine Delivery|"One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341085|NCT03674970|FG002|Participant Flow|Placebo Control|"One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341086|NCT03674970|OG000|Outcome|Random Nicotine Delivery|"One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341087|NCT03674970|OG001|Outcome|Steady State Nicotine Delivery|"One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
10850419|NCT00302328|OG001|Outcome|ICG Peeling|vitrectomy with icg-assisted ilm peeling
10850420|NCT00302328|OG002|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
10850421|NCT00302328|OG000|Outcome|no Peeling|vitrectomy without ilm peeling
10850422|NCT00302328|OG001|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
11242822|NCT02498678|EG001|Reported Event|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
11242823|NCT02498769|BG000|Baseline|Epicardial Botulinum|"After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated."
11242824|NCT02498769|BG001|Baseline|Epicardial Placebo|"After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Placebo"
11242825|NCT02498769|BG002|Baseline|Total|Total of all reporting groups
11242826|NCT02498769|FG000|Participant Flow|Epicardial Botulinum|"After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated."
11242827|NCT02498769|FG001|Participant Flow|Epicardial Placebo|"After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Placebo"
11242828|NCT02498769|OG000|Outcome|Epicardial Botulinum|"After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated."
11242829|NCT02498769|OG001|Outcome|Epicardial Placebo|"After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Placebo"
11242830|NCT02498769|EG000|Reported Event|Epicardial Botulinum|"After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated."
11242831|NCT02498769|EG001|Reported Event|Epicardial Placebo|"After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.~Placebo"
10850423|NCT00302328|OG002|Outcome|tb Peeling|vitrectomy with trypan blue assited ilm peeling
11242832|NCT02498821|BG000|Baseline|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242833|NCT02498821|BG001|Baseline|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242834|NCT02498821|BG002|Baseline|Total|Total of all reporting groups
11242835|NCT02498821|FG000|Participant Flow|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242836|NCT02498821|FG001|Participant Flow|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® Tip Confirmation System (TCS) magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242837|NCT02498821|OG000|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242838|NCT02498821|OG001|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242839|NCT02498821|EG000|Reported Event|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242840|NCT02498821|EG001|Reported Event|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
11242841|NCT02498834|BG000|Baseline|Educational Video and Question Prompt List|"Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.~Educational Video and Question Prompt List: Educational Video and Question Prompt List"
11242842|NCT02498834|BG001|Baseline|Control Group|Standard of care will be used
11242843|NCT02498834|BG002|Baseline|Total|Total of all reporting groups
10850424|NCT00302328|EG000|Reported Event|no Peeling|vitrectomy without ilm peeling
10850425|NCT00302328|EG001|Reported Event|ICG Peeling|vitrectomy with icg assited ilm peeling
10800390|NCT01199380|BG000|Baseline|Standard Treatment (ST)|"Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level."
10850426|NCT00302328|EG002|Reported Event|tb Peeling|vitrectomy with trypan blue assited ilm peeling
11201267|NCT02200211|EG000|Reported Event|Binocular Treatment Younger|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201268|NCT02200211|EG001|Reported Event|Patching Treatment Younger|"Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
11201269|NCT02200211|EG002|Reported Event|Binocular Treatment Older|"Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)~iPad®: Binocular therapy on iPad®"
11201270|NCT02200211|EG003|Reported Event|Patching Treatment Older|"Patching 2 hours per day, 7 days per week~Patching 2 hours per day, 7 days per week"
10850427|NCT00302458|BG000|Baseline|Healthy Volunteers|Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
11201271|NCT02200445|BG000|Baseline|Interleukin-2 Dose A|"Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).~The dose levels will be as follows:~Cohort 1: 0.3x10^6 IU/m^2/day."
11201272|NCT02200445|BG001|Baseline|Interleukin-2 Dose B|- Cohort 2: 1.0x10^6 IU/m^2/day.
11201273|NCT02200445|BG002|Baseline|Interleukin-2 Dose C|- Cohort 3: 1.5x10^6 IU/m^2/day
11201274|NCT02200445|BG003|Baseline|Total|Total of all reporting groups
10850428|NCT00302458|FG000|Participant Flow|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
10850429|NCT00302458|OG000|Outcome|Placebo- Placebo|Healthy volunteers received a placebo, followed by a placebo four hours later
11201275|NCT02200445|FG000|Participant Flow|Interleukin-2 Dose A|"Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).~The dose levels will be as follows:~Cohort 1: 0.3x10^6 IU/m^2/day."
10850430|NCT00302458|OG001|Outcome|IR-MPH + OROS MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
11201276|NCT02200445|FG001|Participant Flow|Interleukin-2 Dose B|- Cohort 2: 1.0x10^6 IU/m^2/day.
11201277|NCT02200445|FG002|Participant Flow|Interleukin-2 Dose C|- Cohort 3: 1.5x10^6 IU/m^2/day
10850431|NCT00302458|OG002|Outcome|IR-MPH +IR-MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
10966335|NCT00886769|OG000|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
10966336|NCT00886769|OG001|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
10966337|NCT00886769|EG000|Reported Event|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
10850432|NCT00302458|OG003|Outcome|OROS-MPH+OROS-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
10850433|NCT00302458|OG004|Outcome|OROS-MPH+ IR-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
10850434|NCT00302458|EG000|Reported Event|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
10966338|NCT00886769|EG001|Reported Event|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
11201278|NCT02200445|OG000|Outcome|Interleukin-2 Dose A|"Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).~The dose levels will be as follows:~Cohort 1: 0.3x10^6 IU/m^2/day."
11201279|NCT02200445|OG001|Outcome|Interleukin-2 Dose B|- Cohort 2: 1.0x10^6 IU/m^2/day.
11201280|NCT02200445|OG002|Outcome|Interleukin-2 Dose C|- Cohort 3: 1.5x10^6 IU/m^2/day
11201281|NCT02200445|EG000|Reported Event|Interleukin-2 Dose A|"Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).~The dose levels will be as follows:~Cohort 1: 0.3x10^6 IU/m^2/day."
11201282|NCT02200445|EG001|Reported Event|Interleukin-2 Dose B|- Cohort 2: 1.0x10^6 IU/m^2/day.
11201283|NCT02200445|EG002|Reported Event|Interleukin-2 Dose C|- Cohort 3: 1.5x10^6 IU/m^2/day
11201284|NCT02200458|BG000|Baseline|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
11201285|NCT02200458|FG000|Participant Flow|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
11201286|NCT02200458|OG000|Outcome|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
11201287|NCT02200458|EG000|Reported Event|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
11201288|NCT02200510|BG000|Baseline|Self-Management Group|"Self-management intervention for Adolescents with SCD - 6 week self-management group~Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11201289|NCT02200510|BG001|Baseline|Patient Portal|"Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention~Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention"
11201290|NCT02200510|BG002|Baseline|Total|Total of all reporting groups
11201291|NCT02200510|FG000|Participant Flow|Self-Management Group|"Self-management intervention for Adolescents with SCD - 6 week self-management group~Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11201292|NCT02200510|FG001|Participant Flow|Patient Portal|"Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention~Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention"
11201293|NCT02200510|OG000|Outcome|Self-Management Group|"Self-management intervention for Adolescents with SCD - 6 week self-management group~Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11201294|NCT02200510|OG001|Outcome|Patient Portal|"Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention~Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention"
10850435|NCT00302718|BG000|Baseline|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
11201295|NCT02200510|EG000|Reported Event|Self-Management Group|"Self-management intervention for Adolescents with SCD - 6 week self-management group~Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11201296|NCT02200510|EG001|Reported Event|Patient Portal|"Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention~Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention"
11201297|NCT02200523|BG000|Baseline|SARA Electrode|"new electrode~SARA electrode"
11242844|NCT02498834|FG000|Participant Flow|Educational Video and Question Prompt List|"Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.~Educational Video and Question Prompt List: Educational Video and Question Prompt List"
11242845|NCT02498834|FG001|Participant Flow|Control Group|Standard of care will be used
11201298|NCT02200523|BG001|Baseline|Gold Cup|"gold standard~Gold cup"
11201299|NCT02200523|BG002|Baseline|Total|Total of all reporting groups
11201300|NCT02200523|FG000|Participant Flow|SARA Electrode|"new electrode~SARA electrode"
11201301|NCT02200523|FG001|Participant Flow|Gold Cup|"gold standard~Gold cup"
11201302|NCT02200523|OG000|Outcome|SARA Electrode|"new electrode~SARA electrode"
11201303|NCT02200523|OG001|Outcome|Gold Cup|"gold standard~Gold cup"
11201304|NCT02200523|EG000|Reported Event|SARA Electrode|"new electrode~SARA electrode"
11201305|NCT02200523|EG001|Reported Event|Gold Cup|"gold standard~Gold cup"
11201306|NCT02200536|BG000|Baseline|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
11201307|NCT02200536|BG001|Baseline|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
11201308|NCT02200536|BG002|Baseline|Control 2|No intervention.
11201309|NCT02200536|BG003|Baseline|Total|Total of all reporting groups
11201310|NCT02200536|FG000|Participant Flow|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
11201311|NCT02200536|FG001|Participant Flow|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
11201312|NCT02200536|FG002|Participant Flow|Control 2|No intervention.
11201313|NCT02200536|OG000|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
11201314|NCT02200536|OG001|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
11201315|NCT02200536|OG002|Outcome|Control 2|No intervention.
11201316|NCT02200536|EG000|Reported Event|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
11201317|NCT02200536|EG001|Reported Event|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
11201318|NCT02200536|EG002|Reported Event|Control 2|No intervention.
11201330|NCT02201056|BG000|Baseline|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
11201331|NCT02201056|BG001|Baseline|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
11201332|NCT02201056|BG002|Baseline|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
11201333|NCT02201056|BG003|Baseline|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
11201334|NCT02201056|BG004|Baseline|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
11201335|NCT02201056|BG005|Baseline|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
11201336|NCT02201056|BG006|Baseline|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
11201337|NCT02201056|BG007|Baseline|Total|Total of all reporting groups
11201338|NCT02201056|FG000|Participant Flow|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
11201339|NCT02201056|FG001|Participant Flow|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
11201340|NCT02201056|FG002|Participant Flow|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
11201341|NCT02201056|FG003|Participant Flow|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
11201342|NCT02201056|FG004|Participant Flow|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
11201343|NCT02201056|FG005|Participant Flow|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
11201344|NCT02201056|FG006|Participant Flow|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
11201345|NCT02201056|OG000|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
11201346|NCT02201056|OG001|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
11201347|NCT02201056|OG002|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
11201348|NCT02201056|OG003|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
11201349|NCT02201056|OG004|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
11201350|NCT02201056|OG005|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
11201351|NCT02201056|OG006|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
11201352|NCT02201056|OG000|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
11201353|NCT02201056|OG001|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
11201354|NCT02201056|OG002|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
11201355|NCT02201056|OG003|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
11201356|NCT02201056|OG004|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
11201357|NCT02201056|OG005|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
11201358|NCT02201056|EG000|Reported Event|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
11201359|NCT02201056|EG001|Reported Event|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
11201360|NCT02201056|EG002|Reported Event|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
11201361|NCT02201056|EG003|Reported Event|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
11201362|NCT02201056|EG004|Reported Event|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
11201363|NCT02201056|EG005|Reported Event|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
11201364|NCT02201056|EG006|Reported Event|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
11201365|NCT02201108|BG000|Baseline|Placebo|Participants received Placebo matching to teriflunomide tablet orally QD for 96 weeks.
11201366|NCT02201108|BG001|Baseline|Teriflunomide|Participants received 1 Teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW >40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg*h/mL.
11201367|NCT02201108|BG002|Baseline|Total|Total of all reporting groups
11201368|NCT02201108|FG000|Participant Flow|Placebo|Participants received Placebo matching to teriflunomide tablet orally once daily (QD) for 96 weeks.
11201369|NCT02201108|FG001|Participant Flow|Teriflunomide|Participants received 1 Teriflunomide tablet, 3.5 milligram (mg) (in case of body weight [BW] up to 40 kilogram [kg]) or 7 mg (in case of BW greater than[>] 40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted pharmacokinetic (PK) parameters, teriflunomide was administered in following manner up to 96 weeks:if predicted PK parameters less than or equal to (<=) 95th percentile of adult range after 7 mg QD:1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW>40 kg); or if predicted PK parameters>95th percentile of adult range:1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW>40 kg). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as maximum concentration observed (Cmax) ranging from 8.03 to 49.10 microgram per milliliter (mcg/mL) and area under the curve from time 0 hour to 24 hours (AUC0-24) ranging from 184 to 1160 microgram*hour per milliliter (mcg*h/mL).
11201370|NCT02201108|OG000|Outcome|Placebo|Participants received Placebo matching to teriflunomide tablet orally QD for 96 weeks.
11201371|NCT02201108|OG001|Outcome|Teriflunomide|Participants received 1 Teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW >40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg*h/mL.
11201372|NCT02201108|OG000|Outcome|Teriflunomide 3.5 mg|Participants with BW up to 40 kg received 1 Teriflunomide tablet, 3.5 mg orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg).
11242846|NCT02498834|OG000|Outcome|Educational Video and Question Prompt List|"Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.~Educational Video and Question Prompt List: Educational Video and Question Prompt List"
11242847|NCT02498834|OG001|Outcome|Control Group|Standard of care will be used
11201373|NCT02201108|OG001|Outcome|Teriflunomide 7 mg|Participants with BW >40 kg received 1 Teriflunomide tablet, 7 mg orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg).
11201374|NCT02201108|OG002|Outcome|Teriflunomide 14 mg|After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg).
11201375|NCT02201108|EG000|Reported Event|Placebo|Participants received Placebo matching to teriflunomide tablet orally QD for 96 weeks.
11201376|NCT02201108|EG001|Reported Event|Teriflunomide|Participants received 1 Teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW >40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg*h/mL.
11201377|NCT02201212|BG000|Baseline|Everolimus|"Everolimus~Fixed doses orally once a day per each 28 day cycle~Participants will stay on study as long as they do not progress for a maximum of 24 months.~Tumor assessments will be performed after every 2 cycles for as long as they are on study.~Everolimus"
11201378|NCT02201212|FG000|Participant Flow|Everolimus|"Everolimus~Fixed doses orally once a day per each 28 day cycle~Participants will stay on study as long as they do not progress for a maximum of 24 months.~Tumor assessments will be performed after every 2 cycles for as long as they are on study.~Everolimus"
11201379|NCT02201212|OG000|Outcome|Everolimus|"Everolimus~Fixed doses orally once a day per each 28 day cycle~Participants will stay on study as long as they do not progress for a maximum of 24 months.~Tumor assessments will be performed after every 2 cycles for as long as they are on study.~Everolimus"
11201380|NCT02201212|EG000|Reported Event|Everolimus|"Everolimus~Fixed doses orally once a day per each 28 day cycle~Participants will stay on study as long as they do not progress for a maximum of 24 months.~Tumor assessments will be performed after every 2 cycles for as long as they are on study.~Everolimus"
11201381|NCT02201277|BG000|Baseline|Denali|Denali brand IVC Filter will be placed in patients randomized to Denali Arm.
11201382|NCT02201277|BG001|Baseline|Option|Option Elite IVC Filter brand IVC Filter will be placed in patients randomized to Option Arm.
11201383|NCT02201277|BG002|Baseline|Total|Total of all reporting groups
11201384|NCT02201277|FG000|Participant Flow|Denali|Denali brand IVC Filter will be placed in patients randomized to Denali Arm.
11201385|NCT02201277|FG001|Participant Flow|Option Elite|Option Elite brand IVC Filter will be placed in patients randomized to Option Arm.
11201386|NCT02201277|OG000|Outcome|Denali|Denali filter randomized participants
11201387|NCT02201277|OG001|Outcome|Option|Option filter randomized participants
11201388|NCT02201277|OG000|Outcome|Denali Filter Tilt|# of participants with tilt greater than or equal to 15 degrees
11201389|NCT02201277|OG001|Outcome|Option Filter Tilt|# of participants with tilt greater than or equal to 15 degrees
11201390|NCT02201277|OG000|Outcome|Denali|"Denali IVC Filter~Filters retrieved %"
11201391|NCT02201277|OG001|Outcome|Option|"Option Elite IVC Filter~Filter retrieved %"
11201392|NCT02201277|EG000|Reported Event|Denali|"Denali brand IVC Filter will be placed in patients randomized to Denali Arm.~24 enrolled"
11201393|NCT02201277|EG001|Reported Event|Option|"Option brand IVC Filter will be placed in patients randomized to Option Arm.~22 enrolled 1 withdrawn by investigator after consent before randomization and 1 patient had 2 filters placed."
11201394|NCT02201290|BG000|Baseline|Eltrombopag|all treated participants
11201395|NCT02201290|FG000|Participant Flow|Eltrombopag|treated participants
11201396|NCT02201290|OG000|Outcome|Eltrombopag|Adverse events by system organ class and maximum severity for all treated participants
11201397|NCT02201290|EG000|Reported Event|Eltrombopag|Eltrombopag was provided to sites by GlaxoSmithKline as tablets or as dry powder for oral suspension (PfOS) sachets
11201398|NCT02201329|BG000|Baseline|Volasertib 200 mg|The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
11201399|NCT02201329|FG000|Participant Flow|Volasertib 200 mg|The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
11201400|NCT02201329|OG000|Outcome|Volasertib 200 mg|The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
11201401|NCT02201329|EG000|Reported Event|Volasertib 200 mg|The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
11201402|NCT02201394|BG000|Baseline|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
11201403|NCT02201394|FG000|Participant Flow|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
11201404|NCT02201394|OG000|Outcome|Loading Dose|Ticagrelor (180 mg) + ASA (325 mg).
11201405|NCT02201394|OG001|Outcome|Maintenance Dose|Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
11201406|NCT02201394|EG000|Reported Event|Patients With Stable CVD|DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
11201407|NCT02201420|BG000|Baseline|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
11201408|NCT02201420|FG000|Participant Flow|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
10850436|NCT00302718|BG001|Baseline|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
10850437|NCT00302718|BG002|Baseline|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
10850438|NCT00302718|BG003|Baseline|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
10850439|NCT00302718|BG004|Baseline|Total|Total of all reporting groups
11201409|NCT02201420|OG000|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
11201410|NCT02201420|EG000|Reported Event|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
11201411|NCT02201446|BG000|Baseline|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
11201412|NCT02201446|BG001|Baseline|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
11201413|NCT02201446|BG002|Baseline|Total|Total of all reporting groups
11201414|NCT02201446|FG000|Participant Flow|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
11201415|NCT02201446|FG001|Participant Flow|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
11201416|NCT02201446|OG000|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
11201417|NCT02201446|OG001|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
11201418|NCT02201446|EG000|Reported Event|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
11201419|NCT02201446|EG001|Reported Event|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
11202358|NCT02207244|OG001|Outcome|Guselkumab Maintenance Group|Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48.
11202359|NCT02207244|OG000|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
11202360|NCT02207244|OG001|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
11202361|NCT02207244|OG000|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
11201420|NCT02201524|BG000|Baseline|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
11201421|NCT02201524|BG001|Baseline|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
11201422|NCT02201524|BG002|Baseline|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
11201423|NCT02201524|BG003|Baseline|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
11201424|NCT02201524|BG004|Baseline|Total|Total of all reporting groups
11201425|NCT02201524|FG000|Participant Flow|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
10966339|NCT00886795|BG000|Baseline|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
11201426|NCT02201524|FG001|Participant Flow|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
11201427|NCT02201524|FG002|Participant Flow|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
10966340|NCT00886795|FG000|Participant Flow|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
10966341|NCT00886795|OG000|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
10849976|NCT00299494|FG004|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with diffuse large B-cell lymphoma (DLBCL) received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849977|NCT00299494|FG005|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with either refractory aggressive or intermediate B-cell non-Hodgkin's lymphoma (NHL) received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11201428|NCT02201524|FG003|Participant Flow|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
11201429|NCT02201524|OG000|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
11201430|NCT02201524|OG001|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
11201431|NCT02201524|OG002|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
11201432|NCT02201524|OG003|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
11201433|NCT02201524|EG000|Reported Event|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
11201434|NCT02201524|EG001|Reported Event|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
11201435|NCT02201524|EG002|Reported Event|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
11201436|NCT02201524|EG003|Reported Event|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
11201437|NCT02201771|BG000|Baseline|Aspirin|"aspirin 100mg tablet by mouth daily for 12 months~Aspirin"
11201438|NCT02201771|BG001|Baseline|Ticagrelor Plus Aspirin|"ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months~Aspirin~Ticagrelor"
11201439|NCT02201771|BG002|Baseline|Ticagrelor|"ticagrelor 90mg tablet by mouth twice daily for 12 months~Ticagrelor"
11201440|NCT02201771|BG003|Baseline|Total|Total of all reporting groups
11201441|NCT02201771|FG000|Participant Flow|Aspirin|"aspirin 100mg tablet by mouth daily for 12 months~Aspirin"
11201442|NCT02201771|FG001|Participant Flow|Ticagrelor Plus Aspirin|"ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months~Aspirin~Ticagrelor"
10849978|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin (0.8 mg/m^2, 1.3 mg/m^2, or 1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849979|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10849980|NCT00299494|OG001|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11201443|NCT02201771|FG002|Participant Flow|Ticagrelor|"ticagrelor 90mg tablet by mouth twice daily for 12 months~Ticagrelor"
11242848|NCT02498834|EG000|Reported Event|Educational Video and Question Prompt List|"Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.~Educational Video and Question Prompt List: Educational Video and Question Prompt List"
11201444|NCT02201771|OG000|Outcome|Aspirin|"aspirin 100mg tablet by mouth daily for 12 months~Aspirin"
11201445|NCT02201771|OG001|Outcome|Ticagrelor Plus Aspirin|"ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months~Aspirin~Ticagrelor"
10849981|NCT00299494|OG002|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11201446|NCT02201771|OG002|Outcome|Ticagrelor|"ticagrelor 90mg tablet by mouth twice daily for 12 months~Ticagrelor"
11201447|NCT02201771|EG000|Reported Event|Aspirin|"aspirin 100mg tablet by mouth daily for 12 months~Aspirin"
11201448|NCT02201771|EG001|Reported Event|Ticagrelor Plus Aspirin|"ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months~Aspirin~Ticagrelor"
11201449|NCT02201771|EG002|Reported Event|Ticagrelor|"ticagrelor 90mg tablet by mouth twice daily for 12 months~Ticagrelor"
11201450|NCT02201784|BG000|Baseline|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
11201451|NCT02201784|BG001|Baseline|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
11201452|NCT02201784|BG002|Baseline|Total|Total of all reporting groups
11201453|NCT02201784|FG000|Participant Flow|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
10966342|NCT00886795|OG000|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks."
11201454|NCT02201784|FG001|Participant Flow|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
11201455|NCT02201784|OG000|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
11201456|NCT02201784|OG001|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
11201457|NCT02201784|EG000|Reported Event|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
11201458|NCT02201784|EG001|Reported Event|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
11201459|NCT02201901|BG000|Baseline|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
11201460|NCT02201901|BG001|Baseline|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
11201461|NCT02201901|BG002|Baseline|SOF/VEL 24 Weeks ((Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
11201462|NCT02201901|BG003|Baseline|Total|Total of all reporting groups
11201463|NCT02201901|FG000|Participant Flow|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
11201464|NCT02201901|FG001|Participant Flow|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
11201465|NCT02201901|FG002|Participant Flow|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
11201466|NCT02201901|OG000|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
11201467|NCT02201901|OG001|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
11201468|NCT02201901|OG002|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
11201469|NCT02201901|OG001|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
11201470|NCT02201901|EG000|Reported Event|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
11201471|NCT02201901|EG001|Reported Event|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
11201472|NCT02201901|EG002|Reported Event|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
11201473|NCT02201940|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11201474|NCT02201940|BG001|Baseline|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
11201475|NCT02201940|BG002|Baseline|Total|Total of all reporting groups
11201476|NCT02201940|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
11201477|NCT02201940|FG001|Participant Flow|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
11201478|NCT02201940|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11201479|NCT02201940|OG001|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
11201480|NCT02201940|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11201481|NCT02201940|EG001|Reported Event|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
11201482|NCT02201953|BG000|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11201483|NCT02201953|BG001|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
11201484|NCT02201953|BG002|Baseline|Total|Total of all reporting groups
11201485|NCT02201953|FG000|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
11201486|NCT02201953|FG001|Participant Flow|SOF+RBV 24 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
11201487|NCT02201953|OG000|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11201488|NCT02201953|OG001|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
11201489|NCT02201953|EG000|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
10849982|NCT00299494|OG003|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11201490|NCT02201953|EG001|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
11201491|NCT02202031|BG000|Baseline|Music Therapy|"Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Music Therapy"
11201492|NCT02202031|BG001|Baseline|Paced Respiration|"Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Paced Respiration"
11201493|NCT02202031|BG002|Baseline|Total|Total of all reporting groups
11201494|NCT02202031|FG000|Participant Flow|Music Therapy|"Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Music Therapy"
11201495|NCT02202031|FG001|Participant Flow|Paced Respiration|"Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Paced Respiration"
11201496|NCT02202031|OG000|Outcome|Music Therapy|"Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Music Therapy"
11201497|NCT02202031|OG001|Outcome|Paced Respiration|"Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Paced Respiration"
11201498|NCT02202031|EG000|Reported Event|Music Therapy|"Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Music Therapy"
11201499|NCT02202031|EG001|Reported Event|Paced Respiration|"Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.~Paced Respiration"
10800391|NCT01199380|BG001|Baseline|Behavioral Activation for Smoking|"Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level."
10800392|NCT01199380|BG002|Baseline|Total|Total of all reporting groups
11201500|NCT02202109|BG000|Baseline|CHWs Facilited Self-Sampling|"CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test~CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes."
11201501|NCT02202109|BG001|Baseline|Mailed Self-Sampler|"Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone~Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;"
11201502|NCT02202109|BG002|Baseline|Total|Total of all reporting groups
11201503|NCT02202109|FG000|Participant Flow|CHWs Facilited Self-Sampling|"CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test~CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes."
11201504|NCT02202109|FG001|Participant Flow|Mailed Self-Sampler|"Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone~Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;"
11201505|NCT02202109|OG000|Outcome|CHWs Facilited Self-Sampling|"CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test~CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes."
11201506|NCT02202109|OG001|Outcome|Mailed Self-Sampler|"Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone~Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;"
11201507|NCT02202109|EG000|Reported Event|CHWs Facilited Self-Sampling|"CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test~CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes."
11201508|NCT02202109|EG001|Reported Event|Mailed Self-Sampler|"Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone~Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;"
11201509|NCT02202135|BG000|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
11201510|NCT02202135|FG000|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
11201511|NCT02202135|OG000|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
11201512|NCT02202135|EG000|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
11242849|NCT02498834|EG001|Reported Event|Control Group|Standard of care will be used
10850440|NCT00302718|FG000|Participant Flow|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
11242850|NCT02499029|BG000|Baseline|N-Acetylcysteine|"Eligible participants were randomized to either NAC (2400 mg/day) or placebo for 8 weeks. The starting dose of NAC was 1200 mg twice daily (2400 mg/day). All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance.~N-acetylcysteine: NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2."
11242851|NCT02499029|BG001|Baseline|Placebo|"Identical appearing placebo capsules were dispensed. All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance. Study medications (USP-grade NAC and matched placebo capsules) dispensed to participants by the medical clinician or study staff. Treatment assignment followed a pre-arranged randomization scheme and was carried out by study personnel at the pharmacy (i.e., personnel not involved in clinical management of participants to preserve the double-blind design).~Placebo: Identical looking placebo pills were administered each week."
11242852|NCT02499029|BG002|Baseline|Total|Total of all reporting groups
11242853|NCT02499029|FG000|Participant Flow|N-Acetylcysteine|"Eligible participants were randomized to either NAC (2400 mg/day) or placebo for 8 weeks. The starting dose of NAC was 1200 mg twice daily (2400 mg/day). All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance.~N-acetylcysteine: NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2."
11242854|NCT02499029|FG001|Participant Flow|Placebo|"Identical appearing placebo capsules were dispensed. All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance. Study medications (USP-grade NAC and matched placebo capsules) dispensed to participants by the medical clinician or study staff. Treatment assignment followed a pre-arranged randomization scheme and was carried out by study personnel at the pharmacy (i.e., personnel not involved in clinical management of participants to preserve the double-blind design).~Placebo: Identical looking placebo pills were administered each week."
11242855|NCT02499029|OG000|Outcome|N-Acetylcysteine|"Eligible participants were randomized to either NAC (2400 mg/day) or placebo for 8 weeks. The starting dose of NAC was 1200 mg twice daily (2400 mg/day). All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance.~N-acetylcysteine: NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2."
11242856|NCT02499029|OG001|Outcome|Placebo|"Identical appearing placebo capsules were dispensed. All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance. Study medications (USP-grade NAC and matched placebo capsules) dispensed to participants by the medical clinician or study staff. Treatment assignment followed a pre-arranged randomization scheme and was carried out by study personnel at the pharmacy (i.e., personnel not involved in clinical management of participants to preserve the double-blind design).~Placebo: Identical looking placebo pills were administered each week."
11242857|NCT02499029|EG000|Reported Event|N-Acetylcysteine|"Eligible participants were randomized to either NAC (2400 mg/day) or placebo for 8 weeks. The starting dose of NAC was 1200 mg twice daily (2400 mg/day). All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance.~N-acetylcysteine: NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2."
11242858|NCT02499029|EG001|Reported Event|Placebo|"Identical appearing placebo capsules were dispensed. All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance. Study medications (USP-grade NAC and matched placebo capsules) dispensed to participants by the medical clinician or study staff. Treatment assignment followed a pre-arranged randomization scheme and was carried out by study personnel at the pharmacy (i.e., personnel not involved in clinical management of participants to preserve the double-blind design).~Placebo: Identical looking placebo pills were administered each week."
11242859|NCT02499081|BG000|Baseline|Ixazomib|"Ixazomib 4.0 mg given on days 1, 8 15, 22 of a 28 day cycle maximum of 6 cycles.~Ixazomib"
11242860|NCT02499081|FG000|Participant Flow|Ixazomib|Ixazomib 4.0 mg given on days 1, 8 15, 22 of a 28 day cycle maximum of 6 cycles.
11242861|NCT02499081|OG000|Outcome|Ixazomib|"Ixazomib 4.0 mg given on days 1, 8 15, 22 of a 28 day cycle maximum of 6 cycles.~Ixazomib"
11242862|NCT02499081|EG000|Reported Event|Ixazomib|"Ixazomib 4.0 mg given on days 1, 8 15, 22 of a 28 day cycle maximum of 6 cycles.~Ixazomib"
11242863|NCT02499120|BG000|Baseline|Palbociclib + Cetuximab|Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242864|NCT02499120|BG001|Baseline|Placebo + Cetuximab|Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute IV infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242865|NCT02499120|BG002|Baseline|Total|Total of all reporting groups
11242866|NCT02499120|FG000|Participant Flow|Palbociclib + Cetuximab|Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242867|NCT02499120|FG001|Participant Flow|Placebo + Cetuximab|Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute IV infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242868|NCT02499120|OG000|Outcome|Palbociclib + Cetuximab|Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11201513|NCT02202161|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201514|NCT02202161|BG001|Baseline|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201515|NCT02202161|BG002|Baseline|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201516|NCT02202161|BG003|Baseline|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
10800393|NCT01199380|FG000|Participant Flow|Standard Treatment (ST)|"Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level."
11201517|NCT02202161|BG004|Baseline|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201518|NCT02202161|BG005|Baseline|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201519|NCT02202161|BG006|Baseline|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
11201520|NCT02202161|BG007|Baseline|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201521|NCT02202161|BG008|Baseline|Total|Total of all reporting groups
11201522|NCT02202161|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally twice daily (BID) for 14 days. Participants drank the contents of dosing bottle (45 milliliters [mL]) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11242869|NCT02499120|OG001|Outcome|Placebo + Cetuximab|Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute IV infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242870|NCT02499120|EG000|Reported Event|Palbociclib + Cetuximab|Participants received Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute intravenous (IV) infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242871|NCT02499120|EG001|Reported Event|Placebo + Cetuximab|Participants received Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle in combination with Cetuximab, 400 mg/m^2 initial dose as a 120-minute IV infusion followed by 250 mg/m^2 weekly infused over 60 minutes.
11242872|NCT02499146|BG000|Baseline|Palbociclib + Letrozole|Participants received palbociclib 125 milligrams (mg) orally once daily (QD) on Day 1 during the 5-day lead-in phase and from Day 1 to Day 21 (followed by 7 days off-treatment) during each treatment cycle. A treatment cycle was defined as 28 days in duration and Cycle 1 was started with Day 6 of lead-in phase as Cycle 1 Day 1. Letrozole 2.5 mg was administered orally QD from Days 1 to 5 during the 5-day lead-in phase and from Days 1 to 28 during each 28-day treatment cycle.
11242873|NCT02499146|FG000|Participant Flow|Palbociclib + Letrozole|Participants received palbociclib 125 milligrams (mg) orally once daily (QD) on Day 1 during the 5-day lead-in phase and from Day 1 to Day 21 (followed by 7 days off-treatment) during each treatment cycle. A treatment cycle was defined as 28 days in duration and Cycle 1 was started with Day 6 of lead-in phase as Cycle 1 Day 1. Letrozole 2.5 mg was administered orally QD from Days 1 to 5 during the 5-day lead-in phase and from Days 1 to 28 during each 28-day treatment cycle.
11242874|NCT02499146|OG000|Outcome|Palbociclib + Letrozole|Participants received palbociclib 125 milligrams (mg) orally once daily (QD) on Day 1 during the 5-day lead-in phase and from Day 1 to Day 21 (followed by 7 days off-treatment) during each treatment cycle. A treatment cycle was defined as 28 days in duration and Cycle 1 was started with Day 6 of lead-in phase as Cycle 1 Day 1. Letrozole 2.5 mg was administered orally QD from Days 1 to 5 during the 5-day lead-in phase and from Days 1 to 28 during each 28-day treatment cycle.
11242875|NCT02499146|EG000|Reported Event|Palbociclib + Letrozole|Participants received palbociclib 125 milligrams (mg) orally once daily (QD) on Day 1 during the 5-day lead-in phase and from Day 1 to Day 21 (followed by 7 days off-treatment) during each treatment cycle. A treatment cycle was defined as 28 days in duration and Cycle 1 was started with Day 6 of lead-in phase as Cycle 1 Day 1. Letrozole 2.5 mg was administered orally QD from Days 1 to 5 during the 5-day lead-in phase and from Days 1 to 28 during each 28-day treatment cycle.
11242876|NCT02499159|BG000|Baseline|Exparel|"Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."
11242877|NCT02499159|BG001|Baseline|0.25% Standard Bupivicaine|"Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle."
11242878|NCT02499159|BG002|Baseline|Total|Total of all reporting groups
11242879|NCT02499159|FG000|Participant Flow|Exparel|"Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."
11242880|NCT02499159|FG001|Participant Flow|0.25% Standard Bupivicaine|"Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle."
11242881|NCT02499159|OG000|Outcome|Exparel|"Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."
11242882|NCT02499159|OG001|Outcome|0.25% Standard Bupivicaine|"Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle."
11242883|NCT02499159|EG000|Reported Event|Exparel|"Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."
11242884|NCT02499159|EG001|Reported Event|0.25% Standard Bupivicaine|"Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.~0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle."
11242885|NCT02499172|BG000|Baseline|Cohort 1|"Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
11242886|NCT02499172|BG001|Baseline|Cohort 3|"Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.~Non-intervention: Non recipients of the vaccine"
11242887|NCT02499172|BG002|Baseline|Cohort 2|Cohort 2: Women who were not pregnant in at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
11242888|NCT02499172|BG003|Baseline|Cohort 4|Cohort 4: Women from Chikwawa who were not pregnant in at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
11242889|NCT02499172|BG004|Baseline|Total|Total of all reporting groups
11242890|NCT02499172|FG000|Participant Flow|Cohort 1|"Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
11201523|NCT02202161|FG001|Participant Flow|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201524|NCT02202161|FG002|Participant Flow|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201525|NCT02202161|FG003|Participant Flow|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201526|NCT02202161|FG004|Participant Flow|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201527|NCT02202161|FG005|Participant Flow|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201528|NCT02202161|FG006|Participant Flow|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
11201529|NCT02202161|FG007|Participant Flow|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201530|NCT02202161|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201531|NCT02202161|OG001|Outcome|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201532|NCT02202161|OG002|Outcome|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201533|NCT02202161|OG003|Outcome|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201534|NCT02202161|OG004|Outcome|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11202362|NCT02207244|OG001|Outcome|Adalimumab|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
11242891|NCT02499172|FG001|Participant Flow|Cohort 3|"Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.~Non-intervention: Non recipients of the vaccine"
11242892|NCT02499172|FG002|Participant Flow|Cohort 2|"Cohort 2: Women who were not pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
11242893|NCT02499172|FG003|Participant Flow|Cohort 4|"Cohort 4: Women who were not pregnant and not received any dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
10849983|NCT00299494|OG004|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
10966343|NCT00886795|EG000|Reported Event|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
10966344|NCT00886821|BG000|Baseline|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
10850441|NCT00302718|FG001|Participant Flow|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
11242894|NCT02499172|OG000|Outcome|Cohort 1|"Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
11242895|NCT02499172|OG001|Outcome|Cohort 3|"Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.~Non-intervention: Non recipients of the vaccine"
11242896|NCT02499172|OG002|Outcome|Cohort 2|Cohort 2: Women who were not pregnant at the time of the vaccination campaign in Nsanje District, but who received receive the vaccine during the campaign.
10966345|NCT00886821|BG001|Baseline|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
10966346|NCT00886821|BG002|Baseline|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
10966347|NCT00886821|BG003|Baseline|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
11201535|NCT02202161|OG005|Outcome|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201536|NCT02202161|OG006|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
11201537|NCT02202161|OG007|Outcome|Run-in Only|Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201538|NCT02202161|OG006|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201539|NCT02202161|OG000|Outcome|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
11201540|NCT02202161|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201541|NCT02202161|EG001|Reported Event|GSK2330672 10 mg BID|Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201542|NCT02202161|EG002|Reported Event|GSK2330672 20 mg BID|Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11202363|NCT02207244|OG001|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
10966348|NCT00886821|BG004|Baseline|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
10966349|NCT00886821|BG005|Baseline|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
11202364|NCT02207244|OG000|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and1 2, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
11242897|NCT02499172|OG003|Outcome|Cohort 4|Cohort 4: Women who were not pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
11242898|NCT02499172|EG000|Reported Event|Cohort 1|"Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.~Shanchol: Oral cholera vaccine"
11242899|NCT02499172|EG001|Reported Event|Cohort 3|"Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.~Non-intervention: Non recipients of the vaccine"
10966350|NCT00886821|BG006|Baseline|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
11242900|NCT02499172|EG002|Reported Event|Cohort 2|Cohort 2: Women who were not pregnant at the time of the vaccination campaign in Nsanje District, but who did receive the vaccine during the campaign.
10966351|NCT00886821|BG007|Baseline|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
10849984|NCT00299494|OG005|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11242901|NCT02499172|EG003|Reported Event|Cohort 4|Cohort 4: Women who were not pregnant at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
10966352|NCT00886821|BG008|Baseline|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
11242902|NCT02499263|BG000|Baseline|Adalimumab|Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
10966353|NCT00886821|BG009|Baseline|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
11242903|NCT02499263|FG000|Participant Flow|Adalimumab|Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
10849985|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
11242904|NCT02499263|OG000|Outcome|Adalimumab|Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
11242905|NCT02499263|EG000|Reported Event|Adalimumab|Adalimumab administered at 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
11242906|NCT02499380|BG000|Baseline|Treatment|"Patients treated with PneumRx Coil System~PneumRx Coil System"
11201543|NCT02202161|EG003|Reported Event|GSK2330672 30 mg BID|Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11242907|NCT02499380|FG000|Participant Flow|Treatment|"Patients treated with PneumRx Coil System~PneumRx Coil System"
10849986|NCT00299494|OG000|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10849987|NCT00299494|OG001|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10849988|NCT00299494|OG002|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
11242908|NCT02499380|OG000|Outcome|Treatment|"Patients treated with PneumRx Coil System~PneumRx Coil System"
11242909|NCT02499380|EG000|Reported Event|Treatment|Patients treated with PneumRx Coil System
11242910|NCT02499406|BG000|Baseline|Skills Group|"Dialectical behavior therapy skills group~Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness"
11242911|NCT02499406|FG000|Participant Flow|Skills Group|"Dialectical behavior therapy skills group~Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness"
11242912|NCT02499406|OG000|Outcome|Skills Group|"Dialectical behavior therapy skills group~Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness"
11242913|NCT02499406|EG000|Reported Event|Skills Group|"Dialectical behavior therapy skills group~Dialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness"
11242914|NCT02499497|BG000|Baseline|Placebo|Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
10966354|NCT00886821|BG010|Baseline|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
10966355|NCT00886821|BG011|Baseline|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10850442|NCT00302718|FG002|Participant Flow|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
10966356|NCT00886821|BG012|Baseline|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10850443|NCT00302718|FG003|Participant Flow|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
10966357|NCT00886821|BG013|Baseline|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10966358|NCT00886821|BG014|Baseline|Total|Total of all reporting groups
10966359|NCT00886821|FG000|Participant Flow|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
11242915|NCT02499497|BG001|Baseline|LY2452473 Dose 1|"The participants will receive 1 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
10966360|NCT00886821|FG001|Participant Flow|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
11242916|NCT02499497|BG002|Baseline|LY2452473 Dose 2|"The participants will receive 5 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242917|NCT02499497|BG003|Baseline|LY2452473 Dose 3|"The participants will receive 15 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242918|NCT02499497|BG004|Baseline|Total|Total of all reporting groups
10966361|NCT00886821|FG002|Participant Flow|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
11242919|NCT02499497|FG000|Participant Flow|Placebo|Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
11242920|NCT02499497|FG001|Participant Flow|LY2452473 Dose 1|"The participants will receive 1 mg LY2452473 daily for 12-weeks.~N-[(2S)-7-cyano-1,2,3,4-tetrahydro-4-(2-pyridinylmethyl)cyclopent[b]indol-2-yl]-,1-methylester (LY2452473): LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
10966362|NCT00886821|FG003|Participant Flow|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
10966363|NCT00886821|FG004|Participant Flow|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
11242921|NCT02499497|FG002|Participant Flow|LY2452473 Dose 2|"The participants will receive 5 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242922|NCT02499497|FG003|Participant Flow|LY2452473 Dose 3|"The participants will receive 15 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242923|NCT02499497|OG000|Outcome|Placebo|Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
11242924|NCT02499497|OG001|Outcome|LY2452473 Dose 1|"The participants will receive 1 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
10966364|NCT00886821|FG005|Participant Flow|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
10966365|NCT00886821|FG006|Participant Flow|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
11242925|NCT02499497|OG002|Outcome|LY2452473 Dose 2|"The participants will receive 5 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242926|NCT02499497|OG003|Outcome|LY2452473 Dose 3|"The participants will receive 15 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242927|NCT02499497|EG000|Reported Event|Placebo|Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
11242928|NCT02499497|EG001|Reported Event|LY2452473 Dose 1|"The participants will receive 1 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242929|NCT02499497|EG002|Reported Event|LY2452473 Dose 2|"The participants will receive 5 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242930|NCT02499497|EG003|Reported Event|LY2452473 Dose 3|"The participants will receive 15 mg LY2452473 daily for 12-weeks.~LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate."
11242931|NCT02499575|BG000|Baseline|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
11242932|NCT02499575|BG001|Baseline|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
11242933|NCT02499575|BG002|Baseline|Total|Total of all reporting groups
11242934|NCT02499575|FG000|Participant Flow|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
11242935|NCT02499575|FG001|Participant Flow|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
11242936|NCT02499575|OG000|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
11242937|NCT02499575|OG001|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
11242938|NCT02499575|EG000|Reported Event|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
11242939|NCT02499575|EG001|Reported Event|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
11242940|NCT02499692|BG000|Baseline|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10850444|NCT00302718|OG000|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
11242941|NCT02499692|FG000|Participant Flow|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
11242942|NCT02499692|OG000|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
11242943|NCT02499692|EG000|Reported Event|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
11242944|NCT02499770|BG000|Baseline|Part 1: Dose Finding/Expansion|The 1st cohort in Part 1 received trilaciclib 200 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 & the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m^2 was given IV daily on Days 1, 2, & 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours & between the dose of trilaciclib & the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours.
11242945|NCT02499770|BG001|Baseline|Part 2: Trilaciclib/Placebo IV With E/P|Eligible participants were randomized (1:1) to trilaciclib or placebo administered IV once daily on Days 1 to 3 of E/P therapy. Randomization was stratified by ECOG performance status (0 to 1 versus 2). Participants received trilaciclib 240 mg/m^2 (recommended dose from Part 1) or placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. Participants received standard E/P chemotherapy in 21-day cycles. The carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1, and 100 mg/m^2 etoposide was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. The interval between doses of trilaciclib/placebo on successive days was not greater than 28 hours and between the dose of trilaciclib/placebo and the first dose of chemotherapy on a given day (etoposide or carboplatin) was not greater than 4 hours.
11242946|NCT02499770|BG002|Baseline|Total|Total of all reporting groups
11201544|NCT02202161|EG004|Reported Event|GSK2330672 60 mg BID|Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201545|NCT02202161|EG005|Reported Event|GSK2330672 90 mg BID|Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
11201546|NCT02202161|EG006|Reported Event|Sitagliptin 50 mg BID|Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing.
11201547|NCT02202252|BG000|Baseline|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
11201548|NCT02202252|BG001|Baseline|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
10966366|NCT00886821|FG007|Participant Flow|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
11242947|NCT02499770|FG000|Participant Flow|Part 1: Dose Finding/Expansion|The 1st cohort in Part 1 received trilaciclib 200 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 & the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m^2 was given IV daily on Days 1, 2, & 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours & between the dose of trilaciclib & the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours.
11242948|NCT02499770|FG001|Participant Flow|Part 2: Trilaciclib/Placebo IV With E/P|Eligible participants were randomized (1:1) to trilaciclib or placebo administered IV once daily on Days 1 to 3 with etoposide and carboplatin on Day 1 and etoposide on Days 2 and 3 of 21-day cycles (E/P). Randomization was stratified by ECOG performance status (0 to 1 versus 2). Participants received trilaciclib 240 mg/m^2 (recommended dose from Part 1) or placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. Participants received standard E/P chemotherapy in 21-day cycles. The carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1, and 100 mg/m^2 etoposide was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. The interval between doses of trilaciclib/placebo on successive days was not greater than 28 hours and between the dose of trilaciclib/placebo and the first dose of chemotherapy on a given day (etoposide or carboplatin) was not greater than 4 hours.
11242949|NCT02499770|OG000|Outcome|Part 1: Cohort 1 Trilaciclib 200 mg/m^2|Participants received trilaciclib 200 mg/m^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242950|NCT02499770|OG001|Outcome|Part 1: Cohort 2 Trilaciclib 240mg/m^2|Participants received trilaciclib 240 mg/m^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242951|NCT02499770|OG000|Outcome|Part 2: Placebo|Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242952|NCT02499770|OG001|Outcome|Part 2: Trilaciclib 240 mg/m^2|Participants received trilaciclib 240 mg/m^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242953|NCT02499770|OG000|Outcome|Part 1: Dose Finding/Expansion|The 1st cohort in Part 1 received trilaciclib 200 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 & the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m^2 was given IV daily on Days 1, 2, & 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours & between the dose of trilaciclib & the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours
11242954|NCT02499770|OG001|Outcome|Part 2: Trilaciclib 240 mg/m^2|Participants received trilaciclib 240 mg/m^2 IV once daily on Days 1 to 3 of each 21- day E/P chemotherapy cycle.
11242955|NCT02499770|EG000|Reported Event|Part 1: Cohort 1 Trilaciclib 200 mg/m^2|Participants received trilaciclib 200 mg/m^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. One participant was screened and dosed at trilaciclib 200 mg/m^2 for Part 2 of the study without being randomized. AEs for this participant are summarized under the Part 1 trilaciclib 200 mg/m^2 cohort for the safety analysis set. One participant was enrolled in the Part 1 trilaciclib 240 mg/m^2 cohort, but dosed at trilaciclib 200 mg/m^2. AEs for this participant's are presented in the trilaciclib 200 mg/m^2 cohort for the safety analysis set.
11242956|NCT02499770|EG001|Reported Event|Part 1: Cohort 2 Trilaciclib 240mg/m^2|Participants received trilaciclib 240 mg/m^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242957|NCT02499770|EG002|Reported Event|Part 2: Placebo|Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242958|NCT02499770|EG003|Reported Event|Part 2: Trilaciclib 240 mg/m^2|Participants received trilaciclib 240 mg/m^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
11242959|NCT02499783|BG000|Baseline|Double-Blind Period: Adalimumab 160/80/40 mg|Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.
11242960|NCT02499783|BG001|Baseline|Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg|Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.
11242961|NCT02499783|BG002|Baseline|Total|Total of all reporting groups
11242962|NCT02499783|FG000|Participant Flow|Double-Blind (DB) Period: Adalimumab 160/80/40 mg|Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.
11242963|NCT02499783|FG001|Participant Flow|DB Period: Placebo Followed by Adalimumab 160/80 mg|Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.
11242964|NCT02499783|FG002|Participant Flow|Open-Label (OL) Period: Adalimumab 40 mg|Open-label adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
11242965|NCT02499783|OG000|Outcome|Double-Blind Period, Weeks 0 to 4: Placebo|Double-blind placebo at Weeks 0 and 2
11242966|NCT02499783|OG001|Outcome|Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg|Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
11242967|NCT02499783|OG000|Outcome|All Participants|"Double-blind period: placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6, OR Double-blind period: adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Weeks 4 and 6.~Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24."
10966367|NCT00886821|FG008|Participant Flow|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
11242968|NCT02499783|OG000|Outcome|Double-Blind Period, Weeks 0 to 4: Placebo|Double-blind placebo at Weeks 0 and 2.
11242969|NCT02499783|OG001|Outcome|Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg|Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2.
11242970|NCT02499783|EG000|Reported Event|Double-Blind Placebo Weeks 0-4|Double-blind placebo at Weeks 0 and 2.
10849989|NCT00299494|OG003|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10966368|NCT00886821|FG009|Participant Flow|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
11201549|NCT02202252|BG002|Baseline|Total|Total of all reporting groups
11242971|NCT02499783|EG001|Reported Event|Double-Blind Adalimumab 160/80 mg Weeks 0-4|Double-blind adalimumab 160/80 mg at Weeks 0 and 2.
10966369|NCT00886821|FG010|Participant Flow|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
11242972|NCT02499783|EG002|Reported Event|Any Adalimumab|Any adalimumab, from first dose of adalimumab to last dose at Week 24.
11201550|NCT02202252|FG000|Participant Flow|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
11201551|NCT02202252|FG001|Participant Flow|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
11201552|NCT02202252|OG000|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
11201553|NCT02202252|OG001|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
11201554|NCT02202252|EG000|Reported Event|Single Drain|Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
11201555|NCT02202252|EG001|Reported Event|Double Drain|Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
11201556|NCT02202317|BG000|Baseline|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
10850445|NCT00302718|OG001|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
11201557|NCT02202317|FG000|Participant Flow|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
11201558|NCT02202317|OG000|Outcome|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
11201559|NCT02202317|EG000|Reported Event|Y90 Based PET/CT Scan|PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
11201560|NCT02202499|BG000|Baseline|Extended Varenicline + Facilitated Extinction|Active Comparator: Extended Varenicline + Facilitated Extinction.
11201561|NCT02202499|BG001|Baseline|Standard Varenicline|Active Comparator: Standard Varenicline (SV).
11201562|NCT02202499|BG002|Baseline|Extended Varenicline|Active Comparator: Extended Varenicline (EV).
11201563|NCT02202499|BG003|Baseline|Total|Total of all reporting groups
11201564|NCT02202499|FG000|Participant Flow|Extended Varenicline + Facilitated Extinction|Active Comparator: Extended Varenicline + Facilitated Extinction.
11201565|NCT02202499|FG001|Participant Flow|Standard Varenicline|Active Comparator: Standard Varenicline (SV).
11201566|NCT02202499|FG002|Participant Flow|Extended Varenicline|Active Comparator: Extended Varenicline (EV).
11201567|NCT02202499|OG000|Outcome|Extended Varenicline + Facilitated Extinction|All participants who received Extended Varenicline + Facilitated Extinction
11201568|NCT02202499|OG001|Outcome|Standard Vareniclline|All participants who received Standard Varenicline (SV)
11201569|NCT02202499|OG002|Outcome|Extended Varenicline|All participants who received Extended Varenicline
11201570|NCT02202499|OG000|Outcome|Extended Varenicline + Facilitated Extinction|All participants who received Extended Varenicline +Facilitated Extinction
11201571|NCT02202499|OG001|Outcome|Standard Vareniclline|All participants who received Standard Varenicline
11201572|NCT02202499|OG000|Outcome|Extended Varenicline + Facilitated Extinction|Active Comparator: Extended Varenicline + Facilitated Extinction.
11201573|NCT02202499|OG001|Outcome|Standard Varenicline|Active Comparator: Standard Varenicline (SV).
11201574|NCT02202499|OG002|Outcome|Extended Varenicline|Active Comparator: Extended Varenicline (EV).
10850446|NCT00302718|OG002|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
11201575|NCT02202499|EG000|Reported Event|Extended Varenicline + Facilitated Extinction|Active Comparator: Extended Varenicline + Facilitated Extinction.
11201576|NCT02202499|EG001|Reported Event|Standard Varenicline|Active Comparator: Standard Varenicline (SV).
11201577|NCT02202499|EG002|Reported Event|Extended Varenicline|Active Comparator: Extended Varenicline (EV).
11201578|NCT02202538|BG000|Baseline|All Subjects|All subjects enrolled in the study used the Indego
11201579|NCT02202538|FG000|Participant Flow|All Subjects|All subjects enrolled in the study used the Indego
11201580|NCT02202538|OG000|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
11201581|NCT02202538|EG000|Reported Event|All Subjects|All subjects enrolled in the study used the Indego
11201582|NCT02202551|BG000|Baseline|Group 1a|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.
11201583|NCT02202551|BG001|Baseline|Group 1P|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study
11201584|NCT02202551|BG002|Baseline|Group 2|Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.
11201585|NCT02202551|BG003|Baseline|Group 3|Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)
11201586|NCT02202551|BG004|Baseline|Total|Total of all reporting groups
11201587|NCT02202551|FG000|Participant Flow|Group 1a|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.
11201588|NCT02202551|FG001|Participant Flow|Group 1P|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study
11201589|NCT02202551|FG002|Participant Flow|Group 2|Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.
11201590|NCT02202551|FG003|Participant Flow|Group 3|Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)
11201591|NCT02202551|OG000|Outcome|Group 1a|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.
11201592|NCT02202551|OG001|Outcome|Group 1P|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study
11201593|NCT02202551|OG002|Outcome|Group 2|Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.
11201594|NCT02202551|OG003|Outcome|Group 3|Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)
11201595|NCT02202551|OG000|Outcome|ADS-5102 1A|Consisting of subjects who received ADS-5102 in the previous Adamas efficacy study
11201596|NCT02202551|OG001|Outcome|ADS-5102 Group 1P|Consisting of subjects who received placebo in the previous Adamas efficacy study
11201597|NCT02202551|OG002|Outcome|ADS-5102 Group 2|Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap
11201598|NCT02202551|OG003|Outcome|ADS-5102 Group 3|Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS
11201599|NCT02202551|EG000|Reported Event|Group 1a|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.
11201600|NCT02202551|EG001|Reported Event|Group 1P|Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study
11201601|NCT02202551|EG002|Reported Event|Group 2|Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.
11201602|NCT02202551|EG003|Reported Event|Group 3|Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)
11201603|NCT02202616|BG000|Baseline|ULTIBRO BREEZHALER|Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
11201604|NCT02202616|FG000|Participant Flow|QVA149 110/50|QVA149 110/50- Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
11201605|NCT02202616|OG000|Outcome|QVA149 110/50 After Flu/Sal|QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with FDC of fluticasone propionate and salmeterol
11201606|NCT02202616|OG001|Outcome|QVA149 110/50 After Tio|QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with tiotropium
11201607|NCT02202616|EG000|Reported Event|QVA149 110/50|QVA149 110/50-Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
11201608|NCT02202746|BG000|Baseline|Lucitanib (CO-3810) 10 mg QD|10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201609|NCT02202746|BG001|Baseline|Lucitanib (CO-3810) 15 mg QD|15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201610|NCT02202746|BG002|Baseline|Total|Total of all reporting groups
11201611|NCT02202746|FG000|Participant Flow|Lucitanib (CO-3810) 10 mg QD|10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201612|NCT02202746|FG001|Participant Flow|Lucitanib (CO-3810) 15 mg QD|15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201613|NCT02202746|OG000|Outcome|Lucitanib (CO-3810) 10 mg QD|10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201614|NCT02202746|OG001|Outcome|Lucitanib (CO-3810) 15 mg QD|15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201615|NCT02202746|OG002|Outcome|All Patients|The total efficacy population analyzed for response
11201616|NCT02202746|OG000|Outcome|Lucitanib (CO-3810) 10 mg QD|10 mg of lucitanib tablet or capsule given orally
11201617|NCT02202746|OG001|Outcome|Lucitanib (CO-3810) 15 mg QD|15 mg of lucitanib tablet or capsule given orally
10850447|NCT00302718|OG003|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
11201618|NCT02202746|EG000|Reported Event|Lucitanib (CO-3810) 10 mg QD|10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201619|NCT02202746|EG001|Reported Event|Lucitanib (CO-3810) 15 mg QD|15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
11201620|NCT02202759|BG000|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201621|NCT02202759|BG001|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
10966370|NCT00886821|FG011|Participant Flow|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
11201622|NCT02202759|BG002|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201623|NCT02202759|BG003|Baseline|Total|Total of all reporting groups
11201624|NCT02202759|FG000|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11242973|NCT02499952|BG000|Baseline|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
11242974|NCT02499952|FG000|Participant Flow|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
11201625|NCT02202759|FG001|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201626|NCT02202759|FG002|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201627|NCT02202759|OG000|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201628|NCT02202759|OG001|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201629|NCT02202759|OG002|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201630|NCT02202759|OG000|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
11201631|NCT02202759|EG000|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
11201632|NCT02202785|BG000|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201633|NCT02202785|BG001|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201634|NCT02202785|BG002|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201635|NCT02202785|BG003|Baseline|Total|Total of all reporting groups
11201636|NCT02202785|FG000|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
10966371|NCT00886821|FG012|Participant Flow|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966372|NCT00886821|FG013|Participant Flow|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10966373|NCT00886821|OG000|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
10966374|NCT00886821|OG001|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
10966375|NCT00886821|OG002|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
10966376|NCT00886821|OG003|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
10966377|NCT00886821|OG004|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
10966378|NCT00886821|OG005|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
10966379|NCT00886821|OG006|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
10966380|NCT00886821|OG007|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
11242975|NCT02499952|OG000|Outcome|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
10966381|NCT00886821|OG008|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
10966382|NCT00886821|OG009|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
10966383|NCT00886821|OG010|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10966384|NCT00886821|OG011|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966385|NCT00886821|OG000|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
10966386|NCT00886821|OG000|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
10966387|NCT00886821|OG001|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10966388|NCT00886821|OG002|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966389|NCT00886821|OG009|Outcome|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
11201637|NCT02202785|FG001|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11242976|NCT02499952|EG000|Reported Event|Experimental Arm|"Pembrolizumab~Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy."
10966390|NCT00886821|OG010|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
11242977|NCT02500043|BG000|Baseline|TAS-102+BSC|Participants received 35 mg/m^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
10966391|NCT00886821|OG011|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10966392|NCT00886821|OG012|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966393|NCT00886821|OG013|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10966394|NCT00886821|OG009|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
11201638|NCT02202785|FG002|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201639|NCT02202785|OG000|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201640|NCT02202785|OG001|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201641|NCT02202785|OG002|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201642|NCT02202785|OG000|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
11201643|NCT02202785|OG002|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
11201644|NCT02202785|EG000|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
11201645|NCT02202837|BG000|Baseline|Etanercept: First Intention|Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201646|NCT02202837|BG001|Baseline|Etanercept: Second Intention|Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201647|NCT02202837|BG002|Baseline|Total|Total of all reporting groups
11201648|NCT02202837|FG000|Participant Flow|Etanercept: First Intention|Participants with rheumatoid arthritis (RA) who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on Summary of Product Characteristics (SmPC).
11201649|NCT02202837|FG001|Participant Flow|Etanercept: Second Intention|Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201650|NCT02202837|OG000|Outcome|Etanercept: First Intention|Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201651|NCT02202837|OG001|Outcome|Etanercept: Second Intention|Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201652|NCT02202837|EG000|Reported Event|Etanercept: First Intention|Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
11201653|NCT02202837|EG001|Reported Event|Etanercept: Second Intention|Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
10966395|NCT00886821|OG010|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
10966396|NCT00886821|OG011|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
10966397|NCT00886821|OG012|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10966398|NCT00886821|OG013|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966399|NCT00886821|OG014|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10966400|NCT00886821|OG003|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10804036|NCT04388319|OG000|Outcome|Combination Zonisamide and Bupropion With E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.~Zonisamide: Zonisamide (100 mg/daily) for 12 weeks.~Bupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.~Halo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."
11242978|NCT02500043|BG001|Baseline|Placebo+BSC|Participants received 35 mg/m^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
10850448|NCT00302718|OG000|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
10966401|NCT00886821|EG000|Reported Event|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
10850449|NCT00302718|OG001|Outcome|Physician-level Incentives|Examines the effect of physician-level financial incentives on hypertension quality of care Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes.
11242979|NCT02500043|BG002|Baseline|Total|Total of all reporting groups
10966402|NCT00886821|EG001|Reported Event|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
11201654|NCT02202850|BG000|Baseline|Etanercept First Cohort|Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.
11201655|NCT02202850|BG001|Baseline|Etanercept Second Cohort|Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
10966403|NCT00886821|EG002|Reported Event|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
11201656|NCT02202850|BG002|Baseline|Total|Total of all reporting groups
11201657|NCT02202850|FG000|Participant Flow|Etanercept First Cohort|Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.
11201658|NCT02202850|FG001|Participant Flow|Etanercept Second Cohort|Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
11201659|NCT02202850|OG000|Outcome|Etanercept First Cohort|Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.
11201660|NCT02202850|OG001|Outcome|Etanercept Second Cohort|Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
11201661|NCT02202850|EG000|Reported Event|Etanercept First Cohort|Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.
11201662|NCT02202850|EG001|Reported Event|Etanercept Second Cohort|Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
10800394|NCT01199380|FG001|Participant Flow|Behavioral Activation for Smoking|"Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.~Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level."
11242980|NCT02500043|FG000|Participant Flow|TAS-102+BSC|Participants received 35 milligrams per meter square (mg/m^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242981|NCT02500043|FG001|Participant Flow|Placebo+BSC|Participants received 35 mg/m^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242982|NCT02500043|OG000|Outcome|TAS-102+BSC|Participants received 35 mg/m^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242983|NCT02500043|OG001|Outcome|Placebo+BSC|Participants received 35 mg/m^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242984|NCT02500043|EG000|Reported Event|TAS-102+BSC|Participants received 35 mg/m^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242985|NCT02500043|EG001|Reported Event|Placebo+BSC|Participants received 35 mg/m^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
11242986|NCT02500056|BG000|Baseline|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
11242987|NCT02500056|BG001|Baseline|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
11242988|NCT02500056|BG002|Baseline|Total|Total of all reporting groups
11242989|NCT02500056|FG000|Participant Flow|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
11242990|NCT02500056|FG001|Participant Flow|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
11242991|NCT02500056|OG000|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
11242992|NCT02500056|OG001|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
11242993|NCT02500056|EG000|Reported Event|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
11242994|NCT02500056|EG001|Reported Event|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
11242995|NCT02500368|BG000|Baseline|Overall Baseline Characteristics|Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
11242996|NCT02500368|FG000|Participant Flow|Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).~silicone hydrogel lens (test): contact lens~enfilcon A lens (control): contact lens"
11242997|NCT02500368|FG001|Participant Flow|Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)|"Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).~enfilcon A lens (control): contact lens~silicone hydrogel lens (test): contact lens"
11242998|NCT02500368|OG000|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
11242999|NCT02500368|OG001|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
11243000|NCT02500368|EG000|Reported Event|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
11243001|NCT02500368|EG001|Reported Event|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
11243002|NCT02500537|BG000|Baseline|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243003|NCT02500537|BG001|Baseline|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243004|NCT02500537|BG002|Baseline|Total|Total of all reporting groups
11243005|NCT02500537|FG000|Participant Flow|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243006|NCT02500537|FG001|Participant Flow|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10966404|NCT00886821|EG003|Reported Event|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
11243007|NCT02500537|OG000|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10966405|NCT00886821|EG004|Reported Event|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
10966406|NCT00886821|EG005|Reported Event|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
10966407|NCT00886821|EG006|Reported Event|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
10850450|NCT00302718|OG002|Outcome|Practice-level Incentives|Examines the effect of practice-level financial incentives on hypertension quality of care Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.
10966408|NCT00886821|EG007|Reported Event|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
10966409|NCT00886821|EG008|Reported Event|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
10966410|NCT00886821|EG009|Reported Event|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
10966411|NCT00886821|EG010|Reported Event|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
11201663|NCT02202980|BG000|Baseline|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
11201664|NCT02202980|BG001|Baseline|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
11201665|NCT02202980|BG002|Baseline|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
11201666|NCT02202980|BG003|Baseline|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
11243008|NCT02500537|OG001|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243009|NCT02500537|OG000|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243010|NCT02500537|EG000|Reported Event|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243011|NCT02500537|EG001|Reported Event|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11243012|NCT02500550|BG000|Baseline|ATIR101|"ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).~Haploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:~Total Body Irradiation (TBI) regime~Non-TBI regime~(See below for details)~TBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)~Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.~Non-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1~ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
11243013|NCT02500550|FG000|Participant Flow|ATIR101|"ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).~Haploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:~Total Body Irradiation (TBI) regime~Non-TBI regime~(See below for details)~TBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)~Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.~Non-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1~ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
11243014|NCT02500550|OG000|Outcome|ATIR101|"ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).~Haploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:~Total Body Irradiation (TBI) regime~Non-TBI regime~(See below for details)~TBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)~Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.~Non-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1~ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
11243015|NCT02500550|EG000|Reported Event|ATIR101|"ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).~Haploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:~Total Body Irradiation (TBI) regime~Non-TBI regime~(See below for details)~TBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)~Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.~Non-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7~Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1~ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
11243016|NCT02500602|BG000|Baseline|Doxazosin|"Participants randomly assigned to receive doxazosin (target dose of 16 mg/day).~doxazosin: active medication"
11243017|NCT02500602|BG001|Baseline|Placebo|"Participants randomly assigned to receive Placebo pill~placebo: placebo pill"
11243018|NCT02500602|BG002|Baseline|Total|Total of all reporting groups
11243019|NCT02500602|FG000|Participant Flow|Doxazosin|"Participants randomly assigned to receive doxazosin (target dose of 16 mg/day).~doxazosin: active medication"
11243020|NCT02500602|FG001|Participant Flow|Placebo|"Participants randomly assigned to receive Placebo pill~placebo: placebo pill"
11243021|NCT02500602|OG000|Outcome|Doxazosin|"Doxazosin (target dose of 16 mg/day). Doxazosin will be initiated at 1 mg/day for the first week, 2mg/day for the second week, 4mg/day for the third week, 8mg/day for the fourth week, and then increase to 16 mg/day for the remaining eight weeks (as tolerated). R~doxazosin: active medication"
11243022|NCT02500602|OG001|Outcome|Placebo|"Placebo pill~placebo: placebo pill"
11243023|NCT02500602|OG000|Outcome|Doxazosin|"Participants randomly assigned to receive doxazosin (target dose of 16 mg/day).~doxazosin: active medication"
11243024|NCT02500602|OG001|Outcome|Placebo|"Participants randomly assigned to receive Placebo pill~placebo: placebo pill"
10966412|NCT00886821|EG011|Reported Event|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
10966413|NCT00886821|EG012|Reported Event|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
10966414|NCT00886821|EG013|Reported Event|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
10966415|NCT00886834|BG000|Baseline|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
10966416|NCT00886834|BG001|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
10966417|NCT00886834|BG002|Baseline|Total|Total of all reporting groups
10966418|NCT00886834|FG000|Participant Flow|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
10966419|NCT00886834|FG001|Participant Flow|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
10966420|NCT00886834|OG000|Outcome|Misoprostol|
10966421|NCT00886834|OG001|Outcome|Placebo|
10966422|NCT00886834|EG000|Reported Event|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
11243025|NCT02500602|EG000|Reported Event|Doxazosin|Participants randomly assigned to receive doxazosin (target dose of 16 mg/day). doxazosin: active medication
11243026|NCT02500602|EG001|Reported Event|Placebo|Participants randomly assigned to receive Placebo pill placebo: placebo pill
10966423|NCT00886834|EG001|Reported Event|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
11243027|NCT02500628|BG000|Baseline|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243028|NCT02500628|BG001|Baseline|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243029|NCT02500628|BG002|Baseline|Total|Total of all reporting groups
11243030|NCT02500628|FG000|Participant Flow|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
11243031|NCT02500628|FG001|Participant Flow|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
11243032|NCT02500628|OG000|Outcome|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243033|NCT02500628|OG001|Outcome|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243034|NCT02500628|OG000|Outcome|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
11243035|NCT02500628|OG001|Outcome|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning~Metformin: 500 mg orally after baseline testing of heart rate"
11243036|NCT02500628|EG000|Reported Event|Fibromyalgia|"Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243037|NCT02500628|EG001|Reported Event|Antipsychotic Use|"Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM~Metformin: 500 mg po after baseline testing of heart rate"
11243038|NCT02500641|BG000|Baseline|Febuxostat 80/120 mg/Day|"Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.~To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used."
11243039|NCT02500641|BG001|Baseline|Allopurinol 100 up to 600 mg/Day|"Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl.~The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.~Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.~Colchicine: Colchicine 0.5 mg tablets.To prevent flares in"
11243040|NCT02500641|BG002|Baseline|Total|Total of all reporting groups
11243041|NCT02500641|FG000|Participant Flow|Febuxostat 80/120 mg/Day|"Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.~To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used."
11243042|NCT02500641|FG001|Participant Flow|Allopurinol 100 up to 600 mg/Day|"Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl.~The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.~Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.~Colchicine: Colchicine 0.5 mg tablets.To prevent flares in"
11243043|NCT02500641|OG000|Outcome|Febuxostat 80/120 mg/Day|"Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.~To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used."
11243044|NCT02500641|OG001|Outcome|Allopurinol 100 up to 600 mg/Day|"Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl.~The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.~Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.~Colchicine: Colchicine 0.5 mg tablets.To prevent flares in"
10800395|NCT01199380|OG000|Outcome|Standard Treatment (ST)|Participants will receive a standard, group smoking cessation treatment equated for contact time, based on the most recent clinical practice guideline for treating tobacco. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will complete between group exercises and will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events. Participants will also receive 8 weeks of the transdermal nicotine patch.
10966424|NCT00886899|BG000|Baseline|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
10966425|NCT00886899|FG000|Participant Flow|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
10966426|NCT00886899|OG000|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
10966427|NCT00886899|EG000|Reported Event|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
10966428|NCT00886938|BG000|Baseline|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
10966429|NCT00886938|FG000|Participant Flow|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
10966430|NCT00886938|OG000|Outcome|rTMS|rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
10966431|NCT00886938|EG000|Reported Event|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
11243045|NCT02500641|EG000|Reported Event|Febuxostat 80/120 mg/Day|"Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.~To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used."
10850451|NCT00302718|OG003|Outcome|Physician- and Practice-level Incentives|Examines the effect of physician and practice-level financial incentives on hypertension quality of care Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives.
11201667|NCT02202980|BG004|Baseline|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
11201668|NCT02202980|BG005|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201669|NCT02202980|BG006|Baseline|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201670|NCT02202980|BG007|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
11201671|NCT02202980|BG008|Baseline|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
11201672|NCT02202980|BG009|Baseline|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
11201673|NCT02202980|BG010|Baseline|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
11201674|NCT02202980|BG011|Baseline|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201675|NCT02202980|BG012|Baseline|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201676|NCT02202980|BG013|Baseline|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
11201677|NCT02202980|BG014|Baseline|Total|Total of all reporting groups
11201678|NCT02202980|FG000|Participant Flow|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)
11201679|NCT02202980|FG001|Participant Flow|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
11201680|NCT02202980|FG002|Participant Flow|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
11201681|NCT02202980|FG003|Participant Flow|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
11201682|NCT02202980|FG004|Participant Flow|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
11201683|NCT02202980|FG005|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201684|NCT02202980|FG006|Participant Flow|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201685|NCT02202980|FG007|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
11201686|NCT02202980|FG008|Participant Flow|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
11201687|NCT02202980|FG009|Participant Flow|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
11201688|NCT02202980|FG010|Participant Flow|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
11201689|NCT02202980|FG011|Participant Flow|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201690|NCT02202980|FG012|Participant Flow|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201691|NCT02202980|FG013|Participant Flow|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
11201692|NCT02202980|OG000|Outcome|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
11201693|NCT02202980|OG001|Outcome|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
11201694|NCT02202980|OG002|Outcome|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
11201695|NCT02202980|OG003|Outcome|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
11201696|NCT02202980|OG004|Outcome|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
11201697|NCT02202980|OG005|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201698|NCT02202980|OG006|Outcome|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201699|NCT02202980|OG007|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
11201700|NCT02202980|OG008|Outcome|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
11201701|NCT02202980|OG009|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
11201702|NCT02202980|OG010|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
11201703|NCT02202980|OG011|Outcome|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201704|NCT02202980|OG012|Outcome|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11243046|NCT02500641|EG001|Reported Event|Allopurinol 100 up to 600 mg/Day|"Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl.~The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used."
11243047|NCT02500706|BG000|Baseline|Faster Aspart (Meal)|"Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243048|NCT02500706|BG001|Baseline|Faster Aspart (Post)|"Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243049|NCT02500706|BG002|Baseline|NovoRapid (Meal)|"After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243050|NCT02500706|BG003|Baseline|Total|Total of all reporting groups
11243051|NCT02500706|FG000|Participant Flow|Faster Aspart (Meal)|"Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243052|NCT02500706|FG001|Participant Flow|Faster Aspart (Post)|"Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243053|NCT02500706|FG002|Participant Flow|NovoRapid (Meal)|"After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243054|NCT02500706|OG000|Outcome|Faster Aspart (Meal)|"Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243055|NCT02500706|OG001|Outcome|Faster Aspart (Post)|"Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243056|NCT02500706|OG002|Outcome|NovoRapid (Meal)|"After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243057|NCT02500706|EG000|Reported Event|Faster Aspart (Meal)|"Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243058|NCT02500706|EG001|Reported Event|Faster Aspart (Post)|"Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243059|NCT02500706|EG002|Reported Event|NovoRapid (Meal)|"After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.~Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period."
11243060|NCT02500719|BG000|Baseline|Healthy Participants|"A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243061|NCT02500719|BG001|Baseline|PTSD Participants|"A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243062|NCT02500719|BG002|Baseline|Total|Total of all reporting groups
11243063|NCT02500719|FG000|Participant Flow|Healthy Participants|"A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243064|NCT02500719|FG001|Participant Flow|PTSD Participants|"A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243065|NCT02500719|OG000|Outcome|Healthy Participants|"A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11339494|NCT03631433|BG000|Baseline|Ibuprofen|"A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.~Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen"
11243066|NCT02500719|OG001|Outcome|PTSD Participants|"A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243067|NCT02500719|EG000|Reported Event|Healthy Participants|"A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243068|NCT02500719|EG001|Reported Event|PTSD Participants|"A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.~Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group."
11243069|NCT02500732|BG000|Baseline|Placebo|"Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.~Placebo: oral placebo capsule designed to blind the atomoxetine intervention"
11243070|NCT02500732|BG001|Baseline|Atomoxetine|"Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.~Atomoxetine: 40mg PO the night before and the morning of the study tilt table test."
11243071|NCT02500732|BG002|Baseline|Total|Total of all reporting groups
11243072|NCT02500732|FG000|Participant Flow|Placebo|"Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.~Placebo: oral placebo capsule designed to blind the atomoxetine intervention"
11243073|NCT02500732|FG001|Participant Flow|Atomoxetine|"Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.~Atomoxetine: 40mg PO the night before and the morning of the study tilt table test."
11243074|NCT02500732|OG000|Outcome|Placebo|"Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.~Placebo: oral placebo capsule designed to blind the atomoxetine intervention"
11243075|NCT02500732|OG001|Outcome|Atomoxetine|"Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.~Atomoxetine: 40mg PO the night before and the morning of the study tilt table test."
11243076|NCT02500732|EG000|Reported Event|Placebo|"Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.~Placebo: oral placebo capsule designed to blind the atomoxetine intervention"
11243077|NCT02500732|EG001|Reported Event|Atomoxetine|"Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.~Atomoxetine: 40mg PO the night before and the morning of the study tilt table test."
11243078|NCT02500758|BG000|Baseline|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243079|NCT02500758|BG001|Baseline|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243080|NCT02500758|BG002|Baseline|Total|Total of all reporting groups
11243081|NCT02500758|FG000|Participant Flow|Parachlorometaxylenol Then Clorhexidine Digluconate|Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).
11243082|NCT02500758|FG001|Participant Flow|Chlorhexidine Digluconate Then Parachlorometaxylenol|"Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).~After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol."
10966432|NCT00887068|BG000|Baseline|AZA Group|Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity.
10800396|NCT01199380|OG001|Outcome|Behavioral Activation for Smoking|Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
10800397|NCT01199380|EG000|Reported Event|Standard Treatment (ST)|"One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.~Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment."
11243083|NCT02500758|OG000|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard"
11243084|NCT02500758|OG001|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243085|NCT02500758|OG000|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243086|NCT02500758|EG000|Reported Event|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243087|NCT02500758|EG001|Reported Event|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
11243088|NCT02500836|BG000|Baseline|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11243089|NCT02500836|BG001|Baseline|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11243090|NCT02500836|BG002|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11243091|NCT02500836|BG003|Baseline|Total|Total of all reporting groups
11243092|NCT02500836|FG000|Participant Flow|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11243093|NCT02500836|FG001|Participant Flow|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11243094|NCT02500836|FG002|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11243095|NCT02500836|OG000|Outcome|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11243096|NCT02500836|OG001|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11243097|NCT02500836|OG000|Outcome|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11243098|NCT02500836|EG000|Reported Event|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
11243099|NCT02500836|EG001|Reported Event|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
11243100|NCT02500836|EG002|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
11243101|NCT02500979|BG000|Baseline|Pramlintide First, Then Placebo|(Treatment Sequence A) - Safety Analysis Set
11243102|NCT02500979|BG001|Baseline|Placebo First, Then Pramlintide|(Treatment Sequence B) - Safety Analysis Set
11243103|NCT02500979|BG002|Baseline|Total|Total of all reporting groups
11243104|NCT02500979|FG000|Participant Flow|Pramlintide First, Then Placebo|(Treatment Sequence A)
10966433|NCT00887068|BG001|Baseline|Standard of Care Group|Best standard of care (ie, no maintenance)
10966434|NCT00887068|BG002|Baseline|Total|Total of all reporting groups
11243105|NCT02500979|FG001|Participant Flow|Placebo First, Then Pramlintide|(Treatment Sequence B)
11201705|NCT02202980|OG013|Outcome|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
11201706|NCT02202980|EG000|Reported Event|LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
11201707|NCT02202980|EG001|Reported Event|LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
11201708|NCT02202980|EG002|Reported Event|LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)|LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
11201709|NCT02202980|EG003|Reported Event|LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)|LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
11201710|NCT02202980|EG004|Reported Event|LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)|LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
11201711|NCT02202980|EG005|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)|VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
10800398|NCT01199380|EG001|Reported Event|Behavioral Activation for Smoking|Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
11243106|NCT02500979|OG000|Outcome|Placebo & Regular Insulin|Placebo was similar sterile solution without pramlintide
10800399|NCT00810017|BG000|Baseline|Single Arm Study|"Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression~Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles~Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease"
11243107|NCT02500979|OG001|Outcome|Pramlintide & Regular Insulin|Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
11201712|NCT02202980|EG006|Reported Event|SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
11201713|NCT02202980|EG007|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
11201714|NCT02202980|EG008|Reported Event|SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
11201715|NCT02202980|EG009|Reported Event|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
11243108|NCT02500979|EG000|Reported Event|Placebo & Regular Insulin|Placebo was similar sterile solution without pramlintide
11201716|NCT02202980|EG010|Reported Event|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
11201717|NCT02202980|EG011|Reported Event|SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
10966435|NCT00887068|FG000|Participant Flow|AZA Group|Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity.
10966436|NCT00887068|FG001|Participant Flow|Standard of Care Group|Best standard of care (ie, no maintenance)
11243109|NCT02500979|EG001|Reported Event|Pramlintide & Regular Insulin|Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
11201718|NCT02202980|EG012|Reported Event|SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
11201719|NCT02202980|EG013|Reported Event|SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)|SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
11201720|NCT02203019|BG000|Baseline|Propofol|"Propofol will be administered for sedation.~Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
10800400|NCT00810017|FG000|Participant Flow|Single Arm Study|"Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression~Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles~Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease"
11243110|NCT02501135|BG000|Baseline|Femoral Nerve Blocks|"Patients who receive ropivacaine or bupivacaine during femoral nerve block.~Femoral nerve block with ropivacaine or bupivacaine"
10800401|NCT00810017|OG000|Outcome|Single Arm Study|"Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression~Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles~Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease"
11243111|NCT02501135|FG000|Participant Flow|Femoral Nerve Blocks|"Patients who receive ropivacaine or bupivacaine during femoral nerve block.~Femoral nerve block with ropivacaine or bupivacaine"
11243112|NCT02501135|OG000|Outcome|Femoral Nerve Blocks|"Patients who receive ropivacaine or bupivacaine during femoral nerve block.~Femoral nerve block with ropivacaine or bupivacaine"
10966437|NCT00887068|OG000|Outcome|AZA Group|Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity.
10966438|NCT00887068|OG001|Outcome|Standard of Care Group|Best standard of care (ie, no maintenance)
11243113|NCT02501135|OG000|Outcome|Femoral Nerve Blocks|"Patients who receive ropivacaine or bupivacaine during femoral nerve block.~Amount of femoral nerve block with ropivacaine or bupivacaine"
11243114|NCT02501135|OG000|Outcome|Intraoperative Tylenol Consumption|Patients who receive ropivacaine or bupivacaine during femoral nerve block and their Tylenol consumptiong during surgery
11243115|NCT02501135|OG000|Outcome|Post Operative Opioid Consumption|Patients who receive ropivacaine or bupivacaine during femoral nerve block and their opioid consumption in PACU
10800402|NCT00810017|EG000|Reported Event|Single Arm Study|"Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression~Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles~Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease"
11243116|NCT02501135|OG000|Outcome|Discharge From PACU in Minutes|The amount of time spent in the post-anesthesia care unit (PACU) in minutes
11201721|NCT02203019|BG001|Baseline|Dexmedetomidine|"Dexmedetomidine will be administered for sedation~Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11201722|NCT02203019|BG002|Baseline|Total|Total of all reporting groups
11201723|NCT02203019|FG000|Participant Flow|Propofol|"Propofol will be administered for sedation.~Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11201724|NCT02203019|FG001|Participant Flow|Dexmedetomidine|"Dexmedetomidine will be administered for sedation~Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11243117|NCT02501135|OG000|Outcome|FLACC Pain Scores|Patients who receive ropivacaine or bupivacaine during femoral nerve block and their FLACC pain scores
11243118|NCT02501135|OG000|Outcome|VAS Pain Scores|Patients who receive ropivacaine or bupivacaine during femoral nerve block and their VAS pain scores
11243119|NCT02501135|EG000|Reported Event|Femoral Nerve Blocks|"Patients who receive ropivacaine or bupivacaine during femoral nerve block.~Femoral nerve block with ropivacaine or bupivacaine"
10966439|NCT00887068|EG000|Reported Event|AZA Group|Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity.
10966440|NCT00887068|EG001|Reported Event|Standard of Care Group|Best standard of care (ie, no maintenance)
10966441|NCT00887159|BG000|Baseline|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
10966442|NCT00887159|BG001|Baseline|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
10966443|NCT00887159|BG002|Baseline|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
10966444|NCT00887159|BG003|Baseline|Total|Total of all reporting groups
10966445|NCT00887159|FG000|Participant Flow|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
11201725|NCT02203019|OG000|Outcome|Propofol|"Propofol will be administered for sedation.~Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11201726|NCT02203019|OG001|Outcome|Dexmedetomidine|"Dexmedetomidine will be administered for sedation~Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
10966446|NCT00887159|FG001|Participant Flow|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
10966447|NCT00887159|FG002|Participant Flow|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
10966448|NCT00887159|OG000|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10966449|NCT00887159|OG001|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
10966450|NCT00887159|OG002|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
10966451|NCT00887159|OG000|Outcome|High CTC Count|High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
10966452|NCT00887159|OG001|Outcome|Low CTC Count|Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
10966453|NCT00887159|EG000|Reported Event|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10966454|NCT00887159|EG001|Reported Event|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
10966455|NCT00887159|EG002|Reported Event|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
10966456|NCT00887198|BG000|Baseline|Abiraterone Acetate + Prednisone (AAP)|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10966457|NCT00887198|BG001|Baseline|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10966458|NCT00887198|BG002|Baseline|Total|Total of all reporting groups
10966459|NCT00887198|FG000|Participant Flow|Abiraterone Acetate + Prednisone (AAP)|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10849990|NCT00299494|OG004|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
10966460|NCT00887198|FG001|Participant Flow|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
11243120|NCT02501161|BG000|Baseline|Insulin Degludec/Liraglutide|Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
10850452|NCT00302718|OG003|Outcome|Physician- and Practice- Level Incentives|Examines the effect of physician and practice-level financial incentives on hypertension quality of care Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives.
10966461|NCT00887198|FG002|Participant Flow|Placebo to AA|Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
10850269|NCT00301067|OG001|Outcome|Cohort 2 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11201727|NCT02203019|EG000|Reported Event|Propofol|"Propofol will be administered for sedation.~Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11201728|NCT02203019|EG001|Reported Event|Dexmedetomidine|"Dexmedetomidine will be administered for sedation~Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.~Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
11201729|NCT02203032|BG000|Baseline|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
11243121|NCT02501161|BG001|Baseline|Insulin Glargine|Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
11243122|NCT02501161|BG002|Baseline|Total|Total of all reporting groups
10850453|NCT00302718|EG000|Reported Event|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
11201730|NCT02203032|FG000|Participant Flow|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
11201731|NCT02203032|FG001|Participant Flow|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
11201732|NCT02203032|FG002|Participant Flow|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
11201733|NCT02203032|FG003|Participant Flow|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
11201734|NCT02203032|OG000|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
11243123|NCT02501161|FG000|Participant Flow|Insulin Degludec/Liraglutide|Participants received subcutaneous (s.c.) injection of Insulin degludec/liraglutide (IDegLira) once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 milligrams [mg] liraglutide) initially. The dose was then escalated twice weekly until the fasting plasma glucose (FPG) target between 4.0-5.0 millimoles per liter (mmol/L) (72-90 milligrams per deciliter [mg/dL]) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
10850454|NCT00302718|EG001|Reported Event|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
11243124|NCT02501161|FG001|Participant Flow|Insulin Glargine|Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
11243125|NCT02501161|OG000|Outcome|Insulin Degludec/Liraglutide|Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
11243126|NCT02501161|OG001|Outcome|Insulin Glargine|Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
11243127|NCT02501161|EG000|Reported Event|Insulin Degludec/Liraglutide|Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
11243128|NCT02501161|EG001|Reported Event|Insulin Glargine|Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
11243129|NCT02501265|BG000|Baseline|Varenicline Standard Protocol|"Participant chooses Varenicline-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Varenicline. Consistent with Varenicline Standard Treatment, 1 week prior to the TQD the participant will switch to active Varenicline and placebo Bupropion. Participant will continue active Varenicline and placebo Bupropion to 12 weeks post-TQD.~Varenicline Standard Protocol: 4 weeks pre-TQD: Start Placebo Varenicline 1 week prior to TQD: Switch to Active Varenicline~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"
11243130|NCT02501265|BG001|Baseline|Nicotine Patch Standard Protocol|"Participant chooses Nicotine patch-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Nicotine Patch. One week prior to TQD, participant will start placebo Bupropion. Consistent with Nicotine Patch Standard Treatment, participant will start active Nicotine Patch on TQD. Participant will continue active Nicotine Patch and placebo Bupropion to 12 weeks post-TQD.~Nicotine Patch Standard Protocol: 4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"
11243131|NCT02501265|BG002|Baseline|Varenicline Adaptive Protocol|"Participant chooses Varenicline treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Varenicline. Two weeks prior to TQD, cigarettes smoked per day is assessed. If the number of cigarettes smoked per day is reduced by >50%, the participant is considered a Varenicline responder, and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Varenicline non-responder and starts active Bupropion 1 week prior to TQD. Varenicline responders will continue active Varenicline and placebo Bupropion to 12 weeks post TQD. Varenicline non-responders will continue active Varenicline and active Bupropion to 12 weeks post TQD.~Varenicline Adaptive Protocol: VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"
11243132|NCT02501265|BG003|Baseline|Nicotine Patch Adaptive Protocol|"Participant chooses Nicotine treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Nicotine Patches. Two weeks prior to TQD, cigarettes smoked per day is assessed. If cigarettes smoked per day is reduced by >50%, the participant is considered a Nicotine Patch responder and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Nicotine Patch non-responder and starts active Bupropion 1 week prior to the TQD. Nicotine Patch responders will continue active Nicotine Patches and placebo Bupropion to 12 weeks post TQD. Nicotine Patch non-responders will continue active Nicotine Patches and Bupropion to 12 weeks post TQD.~Nicotine Adaptive Protocol: NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"
11243133|NCT02501265|BG004|Baseline|Total|Total of all reporting groups
11243134|NCT02501265|FG000|Participant Flow|Varenicline Standard Protocol|"Participant chooses Varenicline-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Varenicline. Consistent with Varenicline Standard Treatment, 1 week prior to the TQD the participant will switch to active Varenicline and placebo Bupropion. Participant will continue active Varenicline and placebo Bupropion to 12 weeks post-TQD.~Varenicline Standard Protocol: 4 weeks pre-TQD: Start Placebo Varenicline 1 week prior to TQD: Switch to Active Varenicline~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"
11243135|NCT02501265|FG001|Participant Flow|Nicotine Patch Standard Protocol|"Participant chooses Nicotine patch-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Nicotine Patch. One week prior to TQD, participant will start placebo Bupropion. Consistent with Nicotine Patch Standard Treatment, participant will start active Nicotine Patch on TQD. Participant will continue active Nicotine Patch and placebo Bupropion to 12 weeks post-TQD.~Nicotine Patch Standard Protocol: 4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"
11201735|NCT02203032|OG001|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
10850455|NCT00302718|EG002|Reported Event|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
10966462|NCT00887198|OG000|Outcome|Abiraterone Acetate + Prednisone (AAP)|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10966463|NCT00887198|OG001|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10850456|NCT00302718|EG003|Reported Event|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
10850457|NCT00302731|BG000|Baseline|Study Arm 1|"Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate~Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate"
10850458|NCT00302731|BG001|Baseline|Study Arm 2|"Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
10850459|NCT00302731|BG002|Baseline|Study Arm 3|"estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
11201736|NCT02203032|EG000|Reported Event|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
11201737|NCT02203032|EG001|Reported Event|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
10850460|NCT00302731|BG003|Baseline|Study Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
10850461|NCT00302731|BG004|Baseline|Total|Total of all reporting groups
11201738|NCT02203032|EG002|Reported Event|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
11201739|NCT02203032|EG003|Reported Event|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
11201740|NCT02203071|BG000|Baseline|MSP Without BioCartilage|Patients receiving marrow stimulating procedure without BioCartilage.
11201741|NCT02203071|BG001|Baseline|MSP With BioCartilage|Patients receiving marrow stimulating procedure with BioCartilage adjunct.
11201742|NCT02203071|BG002|Baseline|Total|Total of all reporting groups
11201743|NCT02203071|FG000|Participant Flow|MSP With BioCartilage|Patients receiving marrow stimulating procedure with BioCartilage adjunct.
11201744|NCT02203071|FG001|Participant Flow|MSP Without BioCartilage|Patients receiving marrow stimulating procedure without BioCartilage.
11201745|NCT02203071|OG000|Outcome|MSP With BioCartilage|Patients receiving marrow stimulating procedure with BioCartilage adjunct.
11201746|NCT02203071|OG001|Outcome|MSP Without BioCartilage|Patients receiving marrow stimulating procedure without BioCartilage.
11201747|NCT02203071|EG000|Reported Event|MSP With BioCartilage|Patients receiving marrow stimulating procedure with BioCartilage adjunct.
11201748|NCT02203071|EG001|Reported Event|MSP Without BioCartilage|Patients receiving marrow stimulating procedure without BioCartilage.
11201749|NCT02203149|BG000|Baseline|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201750|NCT02203149|BG001|Baseline|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201751|NCT02203149|BG002|Baseline|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201752|NCT02203149|BG003|Baseline|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
11201753|NCT02203149|BG004|Baseline|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201754|NCT02203149|BG005|Baseline|Total|Total of all reporting groups
11201755|NCT02203149|FG000|Participant Flow|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201756|NCT02203149|FG001|Participant Flow|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201757|NCT02203149|FG002|Participant Flow|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201758|NCT02203149|FG003|Participant Flow|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
11201759|NCT02203149|FG004|Participant Flow|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201760|NCT02203149|OG000|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201761|NCT02203149|OG001|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
10849900|NCT00299130|OG000|Outcome|Rituximab + MTX|"Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
11201762|NCT02203149|OG002|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201763|NCT02203149|OG003|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
11201764|NCT02203149|OG004|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201765|NCT02203149|OG000|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
11201766|NCT02203149|OG001|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
11201767|NCT02203149|OG000|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
11201768|NCT02203149|OG001|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
11201769|NCT02203149|OG002|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
10800403|NCT00669669|BG000|Baseline|Treatment (Chemotherapy, Autologous Stem Cell Transplant)|"See Detailed Description~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Carmustine: Given IV~Filgrastim: Given SC~In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT~Laboratory Biomarker Analysis: Correlative studies~O6-Benzylguanine: Given IV~Plerixafor: Given SC~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy~Temozolomide: Given PO"
11201770|NCT02203149|OG001|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.
11201771|NCT02203149|OG000|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201772|NCT02203149|OG001|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
11201773|NCT02203149|OG002|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201774|NCT02203149|EG000|Reported Event|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
11201775|NCT02203149|EG001|Reported Event|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
10966464|NCT00887198|OG002|Outcome|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
11201776|NCT02203149|EG002|Reported Event|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201777|NCT02203149|EG003|Reported Event|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
10850462|NCT00302731|FG000|Participant Flow|Participants Randomized to Arm 1|Participants in Arm 1 received Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate
11201778|NCT02203149|EG004|Reported Event|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
11201779|NCT02203149|EG005|Reported Event|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
11201780|NCT02203162|BG000|Baseline|Subjects|all subjects underwent cough challenge testing at baseline and after e-cig exposure
10966465|NCT00887198|EG000|Reported Event|Abiraterone Acetate + Prednisone (AAP)|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10966466|NCT00887198|EG001|Reported Event|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
10966467|NCT00887198|EG002|Reported Event|Placebo to AA|Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
10966468|NCT00887224|BG000|Baseline|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
11201781|NCT02203162|FG000|Participant Flow|Electronic Cigarette Exposure|30 healthy subjects-adult nonsmokers
11201782|NCT02203162|OG000|Outcome|Electronic Cigarette Exposure|30 subjects-healthy adult nonsmokers
11201783|NCT02203162|EG000|Reported Event|Subjects|30 subjects-adult nonsmokers
10966469|NCT00887224|BG001|Baseline|Placebo (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."
10966470|NCT00887224|BG002|Baseline|DVS SR 50 mg (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."
10966471|NCT00887224|BG003|Baseline|Total|Total of all reporting groups
10966472|NCT00887224|FG000|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
10966473|NCT00887224|FG001|Participant Flow|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
10800404|NCT00669669|FG000|Participant Flow|Treatment (Chemotherapy, Autologous Stem Cell Transplant)|"See Detailed Description~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Carmustine: Given IV~Filgrastim: Given SC~In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT~Laboratory Biomarker Analysis: Correlative studies~O6-Benzylguanine: Given IV~Plerixafor: Given SC~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy~Temozolomide: Given PO"
10850463|NCT00302731|FG001|Participant Flow|Participants Randomized to Arm 2|"Participants in Arm 2 received compounded Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
10850270|NCT00301067|OG002|Outcome|Cohort 3 - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11201784|NCT02203331|BG000|Baseline|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
10850464|NCT00302731|FG002|Participant Flow|Participants Randomized to Arm 3|"Participants in Arm 3 received compounded estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
10850465|NCT00302731|FG003|Participant Flow|Participants Randomized to Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
10966474|NCT00887224|FG002|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
11340313|NCT03651479|FG000|Participant Flow|Real Boxing Group|"In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.~real boxing training: In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks."
10966475|NCT00887224|OG000|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
10966476|NCT00887224|OG001|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
11340314|NCT03651479|FG001|Participant Flow|Virtual Boxing Group|"In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.~virtual boxing training: In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks."
11340315|NCT03651479|OG000|Outcome|Real Boxing Group|"In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.~real boxing training: In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks."
11340316|NCT03651479|OG001|Outcome|Virtual Boxing Group|"In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.~virtual boxing training: In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks."
11340317|NCT03651479|EG000|Reported Event|Real Boxing Group|Real boxing training group
11340318|NCT03651479|EG001|Reported Event|Virtual Boxing Group|Virtual boxing training group
11340319|NCT03651856|BG000|Baseline|Atomoxetine|"Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off~ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait"
11340320|NCT03651856|FG000|Participant Flow|Atomoxetine|"Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off~ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait"
11340321|NCT03651856|OG000|Outcome|Atomoxetine|"Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off~ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait"
11340322|NCT03651856|EG000|Reported Event|Atomoxetine|"Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off~ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait"
11340323|NCT03652610|BG000|Baseline|GSK3536820A ACWY_Liq Group|Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.
11340324|NCT03652610|BG001|Baseline|ACWY Group|Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
11340325|NCT03652610|BG002|Baseline|Total|Total of all reporting groups
11340326|NCT03652610|FG000|Participant Flow|GSK3536820A ACWY_Liq Group|Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.
11340327|NCT03652610|FG001|Participant Flow|ACWY Group|Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
11340328|NCT03652610|OG000|Outcome|GSK3536820A ACWY_Liq Group|Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.
11340329|NCT03652610|OG001|Outcome|ACWY Group|Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
11340330|NCT03652610|EG000|Reported Event|GSK3536820A ACWY_Liq Group|Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.
11340331|NCT03652610|EG001|Reported Event|ACWY Group|Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
11340332|NCT03652662|BG000|Baseline|RESP-FIT Intervention|"Intervention:~IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340333|NCT03652662|BG001|Baseline|RESP-FIT Comparator|"Active Comparator:~Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340334|NCT03652662|BG002|Baseline|Total|Total of all reporting groups
11340335|NCT03652662|FG000|Participant Flow|RESP-FIT Intervention|"Intervention:~IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
10966477|NCT00887224|OG001|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
11340336|NCT03652662|FG001|Participant Flow|RESP-FIT Comparator|"Active Comparator:~Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
10966478|NCT00887224|EG000|Reported Event|DVS SR 50 mg (Open-label Response Phase)|DVS SR 50 mg PO QD for 8 weeks.
11340337|NCT03652662|OG000|Outcome|RESP-FIT Intervention|"Intervention:~IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340338|NCT03652662|OG001|Outcome|RESP-FIT Comparator|"Active Comparator:~Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340339|NCT03652662|EG000|Reported Event|RESP-FIT Intervention|"Intervention:~IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340340|NCT03652662|EG001|Reported Event|RESP-FIT Comparator|"Active Comparator:~Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)~RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)"
11340341|NCT03652675|BG000|Baseline|Intervention: (Clinician's Guide + HealthCall for HIV/HCV)|Intervention: (Clinician's Guide + HealthCall for HIV/HCV): This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
11340342|NCT03652675|BG001|Baseline|Educational Control Condition|Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
11340343|NCT03652675|BG002|Baseline|Total|Total of all reporting groups
11340344|NCT03652675|FG000|Participant Flow|Intervention: (Clinician's Guide + HealthCall for HIV/HCV)|Intervention: (Clinician's Guide + HealthCall for HIV/HCV): This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
11340345|NCT03652675|FG001|Participant Flow|Educational Control Condition|Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
11340346|NCT03652675|OG000|Outcome|Intervention: (Clinician's Guide + HealthCall for HIV/HCV)|Intervention: (Clinician's Guide + HealthCall for HIV/HCV): This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
11340347|NCT03652675|OG001|Outcome|Educational Control Condition|Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
11340348|NCT03652675|EG000|Reported Event|Intervention: (Clinician's Guide + HealthCall for HIV/HCV)|Intervention: (Clinician's Guide + HealthCall for HIV/HCV): This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
11340349|NCT03652675|EG001|Reported Event|Educational Control Condition|Participant will spend 20 minutes at the clinic, observed by the counselor, reviewing an educational pamphlet on drinking, HIV, and HCV.
11340350|NCT03652818|BG000|Baseline|Group A/ Placebo Group|Pre-surgery placebo and post-surgery placebo 1 and placebo 2
11340351|NCT03652818|BG001|Baseline|Group B/ APAP Group|Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)
11340352|NCT03652818|BG002|Baseline|Group C/ PGB Group|Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)
11340353|NCT03652818|BG003|Baseline|Group D/ Combination Co-dosing Group|Pre-surgery placebo 1 and post-surgery APAP and PGB
11340354|NCT03652818|BG004|Baseline|Group E/ Combination Split-dosing Group|Pre-surgery PGB and post-surgery placebo 1 and APAP
11340355|NCT03652818|BG005|Baseline|Total|Total of all reporting groups
11340356|NCT03652818|FG000|Participant Flow|Group A/ Placebo Group|Participants received matching placebo capsule orally 60 ± 10 minutes (min) prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and matching placebo (saline 100mL) intravenously (IV). The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion
11340357|NCT03652818|FG001|Participant Flow|Group B/ Acetaminophen (APAP) 1000 mg IV Group|Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 milligram (mg) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.
10966479|NCT00887224|EG001|Reported Event|DVS SR 50 mg (Open Label Stability Phase)|DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
11340358|NCT03652818|FG002|Participant Flow|Group C/ Pregabalin (PGB) 300 mg Capsule Group|Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and matching placebo (saline 100mL) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.
10966480|NCT00887224|EG002|Reported Event|DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)|Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
10966481|NCT00887224|EG003|Reported Event|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
11340359|NCT03652818|FG003|Participant Flow|Group D/ Combination Co-dosing Group (Post-surgery PGB +APAP)|Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and APAP 100 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.
11340360|NCT03652818|FG004|Participant Flow|Group E/ Combination Split-dosing Group (PGB Pre-surgery + APAP Post-surgery)|Participants received PGB 300 mg capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion
11340361|NCT03652818|OG000|Outcome|Group A/ Placebo Group|Pre-surgery placebo and post-surgery placebo 1 and placebo 2
11340362|NCT03652818|OG001|Outcome|Group B/ APAP Group|Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)
11340363|NCT03652818|OG002|Outcome|Group C/ PGB Group|Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)
11340364|NCT03652818|OG003|Outcome|Group D/ Combination Co-dosing Group|Pre-surgery placebo 1 and post-surgery APAP and PGB
11340365|NCT03652818|OG004|Outcome|Group E/ Combination Split-dosing Group|Pre-surgery PGB and post-surgery placebo 1 and APAP
11340366|NCT03652818|EG000|Reported Event|Group A/ Placebo Group|Pre-surgery placebo and post-surgery placebo 1 and placebo 2
11340367|NCT03652818|EG001|Reported Event|Group B/ APAP Group|Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)
11340368|NCT03652818|EG002|Reported Event|Group C/ PGB Group|Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)
11340369|NCT03652818|EG003|Reported Event|Group D/ Combination Co-dosing Group|Pre-surgery placebo 1 and post-surgery APAP and PGB
11340370|NCT03652818|EG004|Reported Event|Group E/ Combination Split-dosing Group|Pre-surgery PGB and post-surgery placebo 1 and APAP
11340371|NCT03653208|BG000|Baseline|Group 1 (hzVSF-v13 10mg)|Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
11340372|NCT03653208|BG001|Baseline|Group 2 (hzVSF-v13 20mg)|Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
11340373|NCT03653208|BG002|Baseline|Group 3 (hzVSF-v13 50mg)|Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
11340374|NCT03653208|BG003|Baseline|Group 4 (hzVSF-v13 100mg)|Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
11340375|NCT03653208|BG004|Baseline|Group 5 (hzVSF-v13 200mg)|Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
11340376|NCT03653208|BG005|Baseline|Group 6 (hzVSF-v13 400mg)|Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
11340377|NCT03653208|BG006|Baseline|Group 7 (hzVSF-v13 800mg)|Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
11340378|NCT03653208|BG007|Baseline|Group 8 (hzVSF-v13 1200mg)|Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
11340379|NCT03653208|BG008|Baseline|Placebo|Placebo group received a single placebo on Day 1.
11340380|NCT03653208|BG009|Baseline|Total|Total of all reporting groups
11340381|NCT03653208|FG000|Participant Flow|Group 1 (hzVSF-v13 10mg)|Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
11340382|NCT03653208|FG001|Participant Flow|Group 2 (hzVSF-v13 20mg)|Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
11340383|NCT03653208|FG002|Participant Flow|Group 3 (hzVSF-v13 50mg)|Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
11340384|NCT03653208|FG003|Participant Flow|Group 4 (hzVSF-v13 100mg)|Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
11340385|NCT03653208|FG004|Participant Flow|Group 5 (hzVSF-v13 200mg)|Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
11340386|NCT03653208|FG005|Participant Flow|Group 6 (hzVSF-v13 400mg)|Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
11340387|NCT03653208|FG006|Participant Flow|Group 7 (hzVSF-v13 800mg)|Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
11340388|NCT03653208|FG007|Participant Flow|Group 8 (hzVSF-v13 1200mg)|Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
11340389|NCT03653208|FG008|Participant Flow|Placebo|Placebo group received a single placebo on Day 1.
11340390|NCT03653208|OG000|Outcome|Group 1 (hzVSF-v13 10mg)|Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
11340391|NCT03653208|OG001|Outcome|Group 2 (hzVSF-v13 20mg)|Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
11340392|NCT03653208|OG002|Outcome|Group 3 (hzVSF-v13 50mg)|Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
11340393|NCT03653208|OG003|Outcome|Group 4 (hzVSF-v13 100mg)|Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
11340394|NCT03653208|OG004|Outcome|Group 5 (hzVSF-v13 200mg)|Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
11340395|NCT03653208|OG005|Outcome|Group 6 (hzVSF-v13 400mg)|Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
11340396|NCT03653208|OG006|Outcome|Group 7 (hzVSF-v13 800mg)|Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
11340397|NCT03653208|OG007|Outcome|Group 8 (hzVSF-v13 1200mg)|Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
11201785|NCT02203331|BG001|Baseline|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201786|NCT02203331|BG002|Baseline|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201787|NCT02203331|BG003|Baseline|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201788|NCT02203331|BG004|Baseline|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201789|NCT02203331|BG005|Baseline|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201790|NCT02203331|BG006|Baseline|Total|Total of all reporting groups
11201791|NCT02203331|FG000|Participant Flow|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
11201792|NCT02203331|FG001|Participant Flow|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201793|NCT02203331|FG002|Participant Flow|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201794|NCT02203331|FG003|Participant Flow|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201795|NCT02203331|FG004|Participant Flow|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201796|NCT02203331|FG005|Participant Flow|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201797|NCT02203331|OG000|Outcome|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
11201798|NCT02203331|OG001|Outcome|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201799|NCT02203331|OG002|Outcome|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201800|NCT02203331|OG003|Outcome|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201801|NCT02203331|OG004|Outcome|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201802|NCT02203331|OG005|Outcome|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201803|NCT02203331|EG000|Reported Event|LNG 40 mcg IVR + Placebo Injection|Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
11201804|NCT02203331|EG001|Reported Event|ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11340398|NCT03653208|OG008|Outcome|Placebo|Placebo group received placebo on Day 1 (single administration).
11340399|NCT03653208|EG000|Reported Event|Group 1 (hzVSF-v13 10mg)|Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
10850492|NCT00302952|OG001|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
11201805|NCT02203331|EG002|Reported Event|ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201806|NCT02203331|EG003|Reported Event|ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection|Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201807|NCT02203331|EG004|Reported Event|Placebo IVR + Leuprorelin Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201808|NCT02203331|EG005|Reported Event|Placebo IVR + Placebo Injection|Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
11201809|NCT02203357|BG000|Baseline|20μg, 0-1-6|117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
11201810|NCT02203357|BG001|Baseline|60μg, 0-1|111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
11201811|NCT02203357|BG002|Baseline|60μg, 0-2|125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
10850493|NCT00302952|EG000|Reported Event|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
11201812|NCT02203357|BG003|Baseline|Total|Total of all reporting groups
11201813|NCT02203357|FG000|Participant Flow|20μg, 0-1-6|117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
11201814|NCT02203357|FG001|Participant Flow|60μg, 0-1|111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
11201815|NCT02203357|FG002|Participant Flow|60μg, 0-2|125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
11201816|NCT02203357|OG000|Outcome|20μg, 0-1-6|117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
11201817|NCT02203357|OG001|Outcome|60μg, 0-1|111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
11201818|NCT02203357|OG002|Outcome|60μg, 0-2|125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
11340400|NCT03653208|EG001|Reported Event|Group 2 (hzVSF-v13 20mg)|Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
11340401|NCT03653208|EG002|Reported Event|Group 3 (hzVSF-v13 50mg)|Group 3 received a single 50mg dose of hzVSF-v13 on Day 1
11340402|NCT03653208|EG003|Reported Event|Group 4 (hzVSF-v13 100mg)|Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
11340403|NCT03653208|EG004|Reported Event|Group 5 (hzVSF-v13 200mg)|Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
11340404|NCT03653208|EG005|Reported Event|Group 6 (hzVSF-v13 400mg)|Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
11340405|NCT03653208|EG006|Reported Event|Group 7 (hzVSF-v13 800mg)|Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
11340406|NCT03653208|EG007|Reported Event|Group 8 (hzVSF-v13 1200mg)|Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
11340407|NCT03653208|EG008|Reported Event|Placebo|Placebo group received placebo on Day 1 (single administration).
11340408|NCT03653351|BG000|Baseline|Sham tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.~Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes)."
11340409|NCT03653351|BG001|Baseline|Active tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.~Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol."
11340410|NCT03653351|BG002|Baseline|Total|Total of all reporting groups
11340411|NCT03653351|FG000|Participant Flow|Sham tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.~Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes)."
11340412|NCT03653351|FG001|Participant Flow|Active tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.~Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol."
11201819|NCT02203357|OG000|Outcome|20μg, 0-1-6|"117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.~Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD."
10849924|NCT00299182|BG003|Baseline|Placebo (Arm A & Arm B) With Chemotherapy|"Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy~Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11201820|NCT02203357|OG001|Outcome|60μg, 0-1|"111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.~Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD."
11201821|NCT02203357|OG002|Outcome|60μg, 0-2|"125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.~Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD."
11201822|NCT02203357|EG000|Reported Event|20μg, 0-1-6|117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
11201823|NCT02203357|EG001|Reported Event|60μg, 0-1|111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
11201824|NCT02203357|EG002|Reported Event|60μg, 0-2|125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
11201825|NCT02203565|BG000|Baseline|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
11201826|NCT02203565|FG000|Participant Flow|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
11201827|NCT02203565|OG000|Outcome|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
11201828|NCT02203565|EG000|Reported Event|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.~Dakin's solution: Applied topically~radiation therapy: Undergo radiation therapy~questionnaire administration: Ancillary studies~laboratory biomarker analysis: Optional correlative studies"
11201829|NCT02203578|BG000|Baseline|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11201830|NCT02203578|FG000|Participant Flow|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11201831|NCT02203578|OG000|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11201832|NCT02203578|EG000|Reported Event|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
11201833|NCT02203591|BG000|Baseline|3M CHG/IPA Prep C - Abdominal|Applied topically for 30 seconds to the abdominal test site
11201834|NCT02203591|BG001|Baseline|3M CHG/IPA Prep CH - Abdominal|Applied topically for 30 seconds to the abdominal test site
11201835|NCT02203591|BG002|Baseline|ChloraPrep - Abdominal|Applied topically for 30 seconds to the abdominal test site
11201836|NCT02203591|BG003|Baseline|Saline - Abdominal|Applied topically for 30 seconds to the abdominal test site
11201837|NCT02203591|BG004|Baseline|3M CHG/IPA Prep C - Inguinal|Applied topically for 2 minutes to the inguinal test site
11201838|NCT02203591|BG005|Baseline|3M CHG/IPA Prep CH - Inguinal|Applied topically for 2 minutes to the inguinal test site
11201839|NCT02203591|BG006|Baseline|ChloraPrep - Inguinal|Applied topically for 2 minutes to the inguinal test site
11201840|NCT02203591|BG007|Baseline|Saline - Inguinal|Applied topically for 2 minutes to the inguinal test site
11201841|NCT02203591|BG008|Baseline|Total|Total of all reporting groups
11201842|NCT02203591|FG000|Participant Flow|3M CHG/IPA Prep C - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201843|NCT02203591|FG001|Participant Flow|3M CHG/IPA Prep CH - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201844|NCT02203591|FG002|Participant Flow|ChloraPrep - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201845|NCT02203591|FG003|Participant Flow|Normal Saline - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201846|NCT02203591|FG004|Participant Flow|3M CHG/IPA Prep C - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201847|NCT02203591|FG005|Participant Flow|3M CHG/IPA Prep CH - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201848|NCT02203591|FG006|Participant Flow|ChloraPrep - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201849|NCT02203591|FG007|Participant Flow|Normal Saline - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201850|NCT02203591|OG000|Outcome|3M CHG/IPA Prep C - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201851|NCT02203591|OG001|Outcome|3M CHG/IPA Prep CH - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201852|NCT02203591|OG002|Outcome|ChloraPrep - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201853|NCT02203591|OG003|Outcome|Normal Saline - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201854|NCT02203591|OG004|Outcome|3M CHG/IPA Prep C - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201855|NCT02203591|OG005|Outcome|3M CHG/IPA Prep CH - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201856|NCT02203591|OG006|Outcome|ChloraPrep - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201857|NCT02203591|OG007|Outcome|Normal Saline - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201858|NCT02203591|OG000|Outcome|3M CHG/IPA Prep C - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201859|NCT02203591|OG001|Outcome|3M CHG/IPA Prep CH - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201860|NCT02203591|OG002|Outcome|ChloraPrep - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201861|NCT02203591|OG000|Outcome|3M CHG/IPA Prep C - Abdominal|"Applied topically to the abdominal region for 30 seconds.~."
11201862|NCT02203591|EG000|Reported Event|3M CHG/IPA Prep C - Abdominal|Applied topically to the abdominal region for 30 seconds.
10966482|NCT00887224|EG004|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
11201863|NCT02203591|EG001|Reported Event|3M CHG/IPA Prep CH - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201864|NCT02203591|EG002|Reported Event|ChloraPrep - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201865|NCT02203591|EG003|Reported Event|Normal Saline - Abdominal|Applied topically to the abdominal region for 30 seconds.
11201866|NCT02203591|EG004|Reported Event|3M CHG/IPA Prep C - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201867|NCT02203591|EG005|Reported Event|3M CHG/IPA Prep CH - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201868|NCT02203591|EG006|Reported Event|ChloraPrep - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201869|NCT02203591|EG007|Reported Event|Normal Saline - Inguinal|Applied topically to the inguinal region for 2 minutes.
11201870|NCT02203630|BG000|Baseline|Phenylephrine|"Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock~Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201871|NCT02203630|BG001|Baseline|Norepinephrine|"Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock~Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201872|NCT02203630|BG002|Baseline|Total|Total of all reporting groups
11201873|NCT02203630|FG000|Participant Flow|Phenylephrine|"Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock~Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201874|NCT02203630|FG001|Participant Flow|Norepinephrine|"Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock~Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201875|NCT02203630|OG000|Outcome|Phenylephrine|"Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock~Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201876|NCT02203630|OG001|Outcome|Norepinephrine|"Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock~Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201877|NCT02203630|EG000|Reported Event|Phenylephrine|"Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock~Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201878|NCT02203630|EG001|Reported Event|Norepinephrine|"Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock~Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock"
11201879|NCT02203721|BG000|Baseline|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
11201880|NCT02203721|BG001|Baseline|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
11201881|NCT02203721|BG002|Baseline|Total|Total of all reporting groups
11201882|NCT02203721|FG000|Participant Flow|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
11201883|NCT02203721|FG001|Participant Flow|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
11201884|NCT02203721|OG000|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
11201885|NCT02203721|OG001|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
11201886|NCT02203721|EG000|Reported Event|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
11201887|NCT02203721|EG001|Reported Event|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
11201888|NCT02203747|BG000|Baseline|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
11201889|NCT02203747|BG001|Baseline|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
11201890|NCT02203747|BG002|Baseline|Total|Total of all reporting groups
11201891|NCT02203747|FG000|Participant Flow|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
11201892|NCT02203747|FG001|Participant Flow|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
11201893|NCT02203747|OG000|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
11201894|NCT02203747|OG001|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
11201895|NCT02203747|EG000|Reported Event|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
11201896|NCT02203747|EG001|Reported Event|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
11201897|NCT02203786|BG000|Baseline|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
11201898|NCT02203786|BG001|Baseline|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
11201899|NCT02203786|BG002|Baseline|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
11201900|NCT02203786|BG003|Baseline|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
11201901|NCT02203786|BG004|Baseline|Total|Total of all reporting groups
10850494|NCT00302952|EG001|Reported Event|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
10850495|NCT00303069|BG000|Baseline|V710 5 μg|V710 5 μg single dose at baseline.
10850496|NCT00303069|BG001|Baseline|V710 30 μg|V710 30 μg single dose at baseline.
10850497|NCT00303069|BG002|Baseline|V710 90 μg|V710 90 μg single dose at baseline.
11243136|NCT02501265|FG002|Participant Flow|Varenicline Adaptive Protocol|"Participant chooses Varenicline treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Varenicline. Two weeks prior to TQD, cigarettes smoked per day is assessed. If the number of cigarettes smoked per day is reduced by >50%, the participant is considered a Varenicline responder, and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Varenicline non-responder and starts active Bupropion 1 week prior to TQD. Varenicline responders will continue active Varenicline and placebo Bupropion to 12 weeks post TQD. Varenicline non-responders will continue active Varenicline and active Bupropion to 12 weeks post TQD.~Varenicline Adaptive Protocol: VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"
11243137|NCT02501265|FG003|Participant Flow|Nicotine Patch Adaptive Protocol|"Participant chooses Nicotine treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Nicotine Patches. Two weeks prior to TQD, cigarettes smoked per day is assessed. If cigarettes smoked per day is reduced by >50%, the participant is considered a Nicotine Patch responder and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Nicotine Patch non-responder and starts active Bupropion 1 week prior to the TQD. Nicotine Patch responders will continue active Nicotine Patches and placebo Bupropion to 12 weeks post TQD. Nicotine Patch non-responders will continue active Nicotine Patches and Bupropion to 12 weeks post TQD.~Nicotine Adaptive Protocol: NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"
11243138|NCT02501265|OG000|Outcome|Varenicline Standard Protocol|"Participant chooses Varenicline-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Varenicline. Consistent with Varenicline Standard Treatment, 1 week prior to the TQD the participant will switch to active Varenicline and placebo Bupropion. Participant will continue active Varenicline and placebo Bupropion to 12 weeks post-TQD.~Varenicline Standard Protocol: 4 weeks pre-TQD: Start Placebo Varenicline 1 week prior to TQD: Switch to Active Varenicline~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"
11243139|NCT02501265|OG001|Outcome|Nicotine Patch Standard Protocol|"Participant chooses Nicotine patch-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Nicotine Patch. One week prior to TQD, participant will start placebo Bupropion. Consistent with Nicotine Patch Standard Treatment, participant will start active Nicotine Patch on TQD. Participant will continue active Nicotine Patch and placebo Bupropion to 12 weeks post-TQD.~Nicotine Patch Standard Protocol: 4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"
11243140|NCT02501265|OG002|Outcome|Varenicline Adaptive Protocol|"Participant chooses Varenicline treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Varenicline. Two weeks prior to TQD, cigarettes smoked per day is assessed. If the number of cigarettes smoked per day is reduced by >50%, the participant is considered a Varenicline responder, and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Varenicline non-responder and starts active Bupropion 1 week prior to TQD. Varenicline responders will continue active Varenicline and placebo Bupropion to 12 weeks post TQD. Varenicline non-responders will continue active Varenicline and active Bupropion to 12 weeks post TQD.~Varenicline Adaptive Protocol: VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"
11243141|NCT02501265|OG003|Outcome|Nicotine Patch Adaptive Protocol|"Participant chooses Nicotine treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Nicotine Patches. Two weeks prior to TQD, cigarettes smoked per day is assessed. If cigarettes smoked per day is reduced by >50%, the participant is considered a Nicotine Patch responder and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Nicotine Patch non-responder and starts active Bupropion 1 week prior to the TQD. Nicotine Patch responders will continue active Nicotine Patches and placebo Bupropion to 12 weeks post TQD. Nicotine Patch non-responders will continue active Nicotine Patches and Bupropion to 12 weeks post TQD.~Nicotine Adaptive Protocol: NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"
11243142|NCT02501265|EG000|Reported Event|Varenicline Standard Protocol|"Participant choses Varenicline-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Varenicline. Consistent with Varenicline Standard Treatment, 1 week prior to the TQD the participant will switch to active Varenicline and placebo Bupropion. Participant will continue active Varenicline and placebo Bupropion to 12 weeks post-TQD.~Varenicline Standard Protocol: 4 weeks pre-TQD: Start Placebo Varenicline 1 week prior to TQD: Switch to Active Varenicline~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"
10850498|NCT00303069|BG003|Baseline|Placebo|Saline placebo single dose at baseline.
10850499|NCT00303069|BG004|Baseline|Total|Total of all reporting groups
10966483|NCT00887224|EG005|Reported Event|Placebo (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
11201902|NCT02203786|FG000|Participant Flow|Haloperidol - Pathological Gamblers|"Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
11201903|NCT02203786|FG001|Participant Flow|Fluphenazine - Pathological Gamblers|"Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
11201904|NCT02203786|FG002|Participant Flow|Haloperidol - Controls|"Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
11201905|NCT02203786|FG003|Participant Flow|Fluphenazine - Controls|"Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
11201906|NCT02203786|OG000|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
11201907|NCT02203786|OG001|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
11201908|NCT02203786|OG002|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
11201909|NCT02203786|OG003|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
11201910|NCT02203786|OG002|Outcome|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
11201911|NCT02203786|OG003|Outcome|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
11202365|NCT02207244|OG000|Outcome|Withdrawal Group|Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 72 until loss of >=50% in the improvement in PASI.
11243143|NCT02501265|EG001|Reported Event|Nicotine Patch Standard Protocol|"Participant choses Nicotine patch-based treatment and is then randomized to Standard Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts placebo Nicotine Patch. One week prior to TQD, participant will start placebo Bupropion. Consistent with Nicotine Patch Standard Treatment, participant will start active Nicotine Patch on TQD. Participant will continue active Nicotine Patch and placebo Bupropion to 12 weeks post-TQD.~Nicotine Patch Standard Protocol: 4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"
11340414|NCT03653351|OG001|Outcome|Active tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.~Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol."
11340415|NCT03653351|EG000|Reported Event|Sham tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.~Sham Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).~Most of the adverse events in this study were mild and transient. They included tingling, itching, pain and redness on the scalp, and headaches. Three participants reported worsening of their depressive symptoms; however, this did not lead them to discontinue the study. There were no safety issues associated with tDCS. Adherence with tDCS administration and in-class attendance were comparable in the sham and active groups, suggesting that active tDCS did not cause adverse effects or discomfort associated with non-adherence."
11340416|NCT03653351|EG001|Reported Event|Active tDCS and MBSR|"Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.~Active Transcranial Direct Current Stimulation (tDCS): Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.~Most of the adverse events in this study were mild and transient. They included tingling, itching, pain and redness on the scalp, and headaches. Three participants reported worsening of their depressive symptoms; however, this did not lead them to discontinue the study. There were no safety issues associated with tDCS. Adherence with tDCS administration and in-class attendance were comparable in the sham and active groups, suggesting that active tDCS did not cause adverse effects or discomfort associated with non-adherence."
11340937|NCT03670160|OG000|Outcome|Phenobarbital|"Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.~Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge."
11340938|NCT03670160|OG001|Outcome|Clonidine|"Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.~Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine."
11340939|NCT03670160|EG000|Reported Event|Phenobarbital|"Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.~Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge."
11340940|NCT03670160|EG001|Reported Event|Clonidine|"Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.~Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine."
11340941|NCT03670264|BG000|Baseline|Quitline Incentive|The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
11340942|NCT03670264|BG001|Baseline|Tobacco Cessation Incentive|The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
10966484|NCT00887224|EG006|Reported Event|DVS SR 50 mg (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
10966485|NCT00887289|BG000|Baseline|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
10966486|NCT00887289|FG000|Participant Flow|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
10966487|NCT00887289|OG000|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
10966488|NCT00887289|EG000|Reported Event|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
10966489|NCT00887341|BG000|Baseline|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
11201912|NCT02203786|EG000|Reported Event|Haloperidol - Pathological Gamblers|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
11201913|NCT02203786|EG001|Reported Event|Fluphenazine - Pathological Gamblers|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
11340417|NCT03653416|BG000|Baseline|Pai (Peri Articular) Group|Patients received adductor canal catheter and peri articular infiltration.
11340418|NCT03653416|BG001|Baseline|Ipack Group|"20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.~Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee."
11340419|NCT03653416|BG002|Baseline|Total|Total of all reporting groups
11340420|NCT03653416|FG000|Participant Flow|Ipack Group|"20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.~Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee."
11340421|NCT03653416|FG001|Participant Flow|Pai (Peri Articular) Group|Patients received adductor canal catheter and peri articular infiltration.
11340422|NCT03653416|OG000|Outcome|Ipack Group|"20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.~Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee."
11340423|NCT03653416|OG001|Outcome|Pai (Peri Articular) Group|Patients received adductor canal catheter and peri articular infiltration.
11340424|NCT03653416|EG000|Reported Event|Ipack Group|"20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well.~Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee."
11340425|NCT03653416|EG001|Reported Event|Pai (Peri Articular) Group|Patients received adductor canal catheter and peri articular infiltration.
10966490|NCT00887341|BG001|Baseline|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
10966491|NCT00887341|BG002|Baseline|Total|Total of all reporting groups
10966492|NCT00887341|FG000|Participant Flow|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
10966493|NCT00887341|FG001|Participant Flow|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
10966494|NCT00887341|OG000|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
10966495|NCT00887341|OG001|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
11340426|NCT03653429|BG000|Baseline|Tranexamic Acid Group|10mg/kg intravenous tranexamic acid administered prior to surgical incision
11340427|NCT03653429|BG001|Baseline|Normal Saline Group|10mg/kg intravenous normal saline administered prior to surgical incision
11202366|NCT02207244|OG001|Outcome|Guselkumab Maintenance Group|Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32, 40 and thereafter through Week 72.
11340428|NCT03653429|BG002|Baseline|Total|Total of all reporting groups
11340429|NCT03653429|FG000|Participant Flow|Tranexamic Acid Group|10mg/kg intravenous tranexamic acid administered prior to surgical incision
11340430|NCT03653429|FG001|Participant Flow|Normal Saline Group|10mg/kg intravenous normal saline administered prior to surgical incision
10966496|NCT00887341|EG000|Reported Event|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
11340431|NCT03653429|OG000|Outcome|Tranexamic Acid Group|10mg/kg intravenous tranexamic acid administered prior to surgical incision
11340432|NCT03653429|OG001|Outcome|Normal Saline Group|10mg/kg intravenous normal saline administered prior to surgical incision
11340433|NCT03653429|EG000|Reported Event|Tranexamic Acid Group|10mg/kg intravenous tranexamic acid administered prior to surgical incision
11340434|NCT03653429|EG001|Reported Event|Normal Saline Group|10mg/kg intravenous normal saline administered prior to surgical incision
11340435|NCT03654326|BG000|Baseline|Gefapixant|Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340436|NCT03654326|BG001|Baseline|Placebo|Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340437|NCT03654326|BG002|Baseline|Total|Total of all reporting groups
11340438|NCT03654326|FG000|Participant Flow|Gefapixant|Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340439|NCT03654326|FG001|Participant Flow|Placebo|Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340440|NCT03654326|OG000|Outcome|Gefapixant|Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340441|NCT03654326|OG001|Outcome|Placebo|Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340442|NCT03654326|EG000|Reported Event|Gefapixant|Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340443|NCT03654326|EG001|Reported Event|Placebo|Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
11340444|NCT03654417|BG000|Baseline|EMLA|Lidocaine: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340445|NCT03654417|BG001|Baseline|Lidocaine|EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340446|NCT03654417|BG002|Baseline|Total|Total of all reporting groups
11340447|NCT03654417|FG000|Participant Flow|EMLA|Lidocaine: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340448|NCT03654417|FG001|Participant Flow|Lidocaine|EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340449|NCT03654417|OG000|Outcome|EMLA|Lidocaine: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340450|NCT03654417|OG001|Outcome|Lidocaine|EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340451|NCT03654417|EG000|Reported Event|EMLA|Lidocaine: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340452|NCT03654417|EG001|Reported Event|Lidocaine|EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
11340453|NCT03654560|BG000|Baseline|HemoStyp|"Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.~HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use."
11340454|NCT03654560|BG001|Baseline|Surgicel|"Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.~Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use."
11340455|NCT03654560|BG002|Baseline|Total|Total of all reporting groups
11201914|NCT02203786|EG002|Reported Event|Haloperidol - Controls|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
11202367|NCT02207244|OG000|Outcome|Guselkumab Combined|All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
11340970|NCT03670810|FG001|Participant Flow|200 mg Lasmiditan|Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
11340971|NCT03670810|FG002|Participant Flow|Control 1 Sequence|"Control 1:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.~Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks."
11340972|NCT03670810|FG003|Participant Flow|Control 2 Sequence|"Control 2:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.~Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks."
11340973|NCT03670810|OG000|Outcome|100 mg Lasmiditan|Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
11340974|NCT03670810|OG001|Outcome|200 mg Lasmiditan|Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
11340975|NCT03670810|OG002|Outcome|Placebo|"Control 1:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.~Control 2:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4."
11340976|NCT03670810|OG000|Outcome|100 mg Lasmiditan|Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
11340977|NCT03670810|OG002|Outcome|Control|"Control 1:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.~Control 2:~Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.~Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4."
11340978|NCT03670810|EG000|Reported Event|100 Milligram (mg) Lasmiditan|Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
11340979|NCT03670810|EG001|Reported Event|200 mg Lasmiditan|Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
11340980|NCT03670810|EG002|Reported Event|Control|"Control 1 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.~Control 2 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4."
11340981|NCT03672006|BG000|Baseline|Alteplase|"10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)~alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter"
11340982|NCT03672006|BG001|Baseline|Heparin|"9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)~Heparin: Medication administered to dwell in central venous catheter"
11340983|NCT03672006|BG002|Baseline|Total|Total of all reporting groups
11340984|NCT03672006|FG000|Participant Flow|Alteplase|"10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)~alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter"
11340985|NCT03672006|FG001|Participant Flow|Heparin|"9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)~Heparin: Medication administered to dwell in central venous catheter"
11340986|NCT03672006|OG000|Outcome|Alteplase|"10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)~alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter"
11201915|NCT02203786|EG003|Reported Event|Fluphenazine - Controls|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
11201916|NCT02203838|BG000|Baseline|De Novo Participants|"Participants who were not part of the previous double-blind study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201917|NCT02203838|BG001|Baseline|Rollover Placebo|"Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201918|NCT02203838|BG002|Baseline|Rollover RBP-7000 90 mg|"Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201919|NCT02203838|BG003|Baseline|Rollover RBP-7000 120 mg|"Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201920|NCT02203838|BG004|Baseline|Total|Total of all reporting groups
11201921|NCT02203838|FG000|Participant Flow|De Novo Participants|"Participants who were not part of the previous double-blind study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg of RBP-7000 at the discretion of the investigator."
11201922|NCT02203838|FG001|Participant Flow|Rollover Placebo|"Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201923|NCT02203838|FG002|Participant Flow|Rollover RBP-7000 90 mg|"Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201924|NCT02203838|FG003|Participant Flow|Rollover RBP-7000 120 mg|"Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201925|NCT02203838|OG000|Outcome|De Novo Participants|"Participants who were not part of the previous double-blind study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201926|NCT02203838|OG001|Outcome|Rollover Placebo|"Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201927|NCT02203838|OG002|Outcome|Rollover RBP-7000 90 mg|"Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201928|NCT02203838|OG003|Outcome|Rollover RBP-7000 120 mg|"Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201929|NCT02203838|EG000|Reported Event|De Novo Participants|"Participants who were not part of the previous double-blind study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201930|NCT02203838|EG001|Reported Event|Rollover Placebo|"Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201931|NCT02203838|EG002|Reported Event|Rollover RBP-7000 90 mg|"Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201932|NCT02203838|EG003|Reported Event|Rollover RBP-7000 120 mg|"Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.~Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).~A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator."
11201933|NCT02203851|BG000|Baseline|Risankizumab 90 mg or 180 mg|Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201934|NCT02203851|FG000|Participant Flow|Risankizumab 90 mg or 180 mg|Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201935|NCT02203851|OG000|Outcome|Risankizumab 90 mg|Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.
11201936|NCT02203851|OG001|Outcome|Risankizumab 180 mg|Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.
11201937|NCT02203851|OG000|Outcome|Risankizumab 18 mg/Risankizumab|Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201938|NCT02203851|OG001|Outcome|Risankizumab 90 mg/Risankizumab|Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201939|NCT02203851|OG002|Outcome|Risankizumab 180 mg/Risankizumab|Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201940|NCT02203851|OG003|Outcome|Ustekinumab/Risankizumab|Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201941|NCT02203851|OG000|Outcome|Risankizumab 18 mg/Risankizumab|Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeksfor approximately 4 years from the first dose in either the lead-in or extension study.
11201942|NCT02203851|EG000|Reported Event|Risankizumab 90 mg|Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201943|NCT02203851|EG001|Reported Event|Risankizumab 180 mg|Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
11201944|NCT02203916|BG000|Baseline|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
11201945|NCT02203916|BG001|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
11201946|NCT02203916|BG002|Baseline|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
11201947|NCT02203916|BG003|Baseline|Total|Total of all reporting groups
11201948|NCT02203916|FG000|Participant Flow|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
11201949|NCT02203916|FG001|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
11201950|NCT02203916|FG002|Participant Flow|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
11201951|NCT02203916|OG000|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
11201952|NCT02203916|OG001|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
11201953|NCT02203916|OG002|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
11201954|NCT02203916|EG000|Reported Event|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
11201955|NCT02203916|EG001|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
11201956|NCT02203916|EG002|Reported Event|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
11201957|NCT02204007|BG000|Baseline|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
11201958|NCT02204007|BG001|Baseline|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
11201959|NCT02204007|BG002|Baseline|Total|Total of all reporting groups
11201960|NCT02204007|FG000|Participant Flow|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
11201961|NCT02204007|FG001|Participant Flow|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
11201962|NCT02204007|OG000|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
11201963|NCT02204007|OG001|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
11201964|NCT02204007|EG000|Reported Event|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
11201965|NCT02204007|EG001|Reported Event|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
11201966|NCT02204124|BG000|Baseline|Control Group|In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
11201967|NCT02204124|BG001|Baseline|Thunderbeat™|"In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).~Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator."
11201968|NCT02204124|BG002|Baseline|Total|Total of all reporting groups
11243144|NCT02501265|EG002|Reported Event|Varenicline Adaptive Protocol|"Participant chooses Varenicline treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Varenicline. Two weeks prior to TQD, cigarettes smoked per day is assessed. If the number of cigarettes smoked per day is reduced by >50%, the participant is considered a Varenicline responder, and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Varenicline non-responder and starts active Bupropion 1 week prior to TQD. Varenicline responders will continue active Varenicline and placebo Bupropion to 12 weeks post TQD. Varenicline non-responders will continue active Varenicline and active Bupropion to 12 weeks post TQD.~Varenicline Adaptive Protocol: VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"
11243145|NCT02501265|EG003|Reported Event|Nicotine Patch Adaptive Protocol|"Participant choses Nicotine treatment and is randomized to Adaptive Treatment arm (N=75). Four weeks prior to target quit date (TQD), participant starts active Nicotine Patches. Two weeks prior to TQD, cigarettes smoked per day is assessed. If cigarettes smoked per day is reduced by >50%, the participant is considered a Nicotine Patch responder and starts placebo Bupropion 1 week prior to the TQD. If the participant DOES NOT reduce cigarettes smoked per day by >50%, the participant is considered a Nicotine Patch non-responder and starts active Bupropion 1 week prior to the TQD. Nicotine Patch responders will continue active Nicotine Patches and placebo Bupropion to 12 weeks post TQD. Nicotine Patch non-responders will continue active Nicotine Patches and Bupropion to 12 weeks post TQD.~Nicotine Adaptive Protocol: NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"
11243146|NCT02501473|BG000|Baseline|Part 1: Local Radiation + G100 5μg/Tumor|Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
11243147|NCT02501473|BG001|Baseline|Part 1: Local Radiation + G100 10μg/Tumor|Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243148|NCT02501473|BG002|Baseline|Part 2: Local Radiation + G100 10μg/Tumor|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243149|NCT02501473|BG003|Baseline|Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
11243150|NCT02501473|BG004|Baseline|Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors|Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
11243151|NCT02501473|BG005|Baseline|Part 3: Local Radiation + G100 20μg/Tumor|Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243152|NCT02501473|BG006|Baseline|Part 4: G100 20μg/Tumor and Pembrolizumab 200mg|Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
11243153|NCT02501473|BG007|Baseline|Total|Total of all reporting groups
11243154|NCT02501473|FG000|Participant Flow|Part 1: Local Radiation + G100 5μg/Tumor|Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
11243155|NCT02501473|FG001|Participant Flow|Part 1: Local Radiation + G100 10μg/Tumor|Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243156|NCT02501473|FG002|Participant Flow|Part 2: Local Radiation + G100 10μg/Tumor|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243157|NCT02501473|FG003|Participant Flow|Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
11243158|NCT02501473|FG004|Participant Flow|Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors|Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
11243159|NCT02501473|FG005|Participant Flow|Part 3: Local Radiation + G100 20μg/Tumor|Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243160|NCT02501473|FG006|Participant Flow|Part 4: G100 20μg/Tumor and Pembrolizumab 200mg|Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
11243161|NCT02501473|FG007|Participant Flow|Part 5: G100 + Rituximab 375 mg/m^2|Part 5: G100 administered at 20, 40, 60, or 80 μg/tumor for up to 6 weeks and rituximab (anti-CD20 antibody). Rituximab dose administered as an IV infusion at 375 mg/m^2 administered on Day 0 and then once weekly for 4 doses up to 3 weeks.
11243162|NCT02501473|OG000|Outcome|Part 1: Local Radiation + G100 5μg/Tumor|Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
11243163|NCT02501473|OG001|Outcome|Part 1: Local Radiation + G100 10μg/Tumor|Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243164|NCT02501473|OG002|Outcome|Part 2: Local Radiation + G100 10μg/Tumor|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243165|NCT02501473|OG003|Outcome|Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
11243166|NCT02501473|OG004|Outcome|Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors|Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
11201969|NCT02204124|FG000|Participant Flow|Control Group|In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
11201970|NCT02204124|FG001|Participant Flow|Thunderbeat™|"In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).~Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator."
11201971|NCT02204124|OG000|Outcome|Control Group|In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
11201972|NCT02204124|OG001|Outcome|Thunderbeat™|"In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).~Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator."
11201973|NCT02204124|EG000|Reported Event|Control Group|In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
11201974|NCT02204124|EG001|Reported Event|Thunderbeat™|"In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).~Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator."
11201975|NCT02204150|BG000|Baseline|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11201976|NCT02204150|FG000|Participant Flow|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11201977|NCT02204150|OG000|Outcome|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11201978|NCT02204150|EG000|Reported Event|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11201979|NCT02204176|BG000|Baseline|Exercise Information|This group was presented with information that defined and described regular exercise, its benefits, and guidance for using proper form in exercise to minimize the risk of injury. Guidelines for prescribing suggested physical activities were based on recommendations from the USDHHS (2008). These sessions lasted ~90 minutes.
11201980|NCT02204176|BG001|Baseline|Action Planning|This group discussed all the components from the session for the information-only group with an additional emphasis on how to create action plans. Discussions revolved around possible ways and times of the day to engage in exercise by making specific action plans that designate when, where, and how. Participants were shown how to create an example action plan and guided in writing their own exercise action plans for as many days as they desired in the three-week tracking period in their exercise booklets. Emphasis was placed on the specificity and feasibility of the plans. These sessions lasted ~120 minutes.
11201981|NCT02204176|BG002|Baseline|Realistic Effort Action Planning|This group discussed all components from the action planning condition. Discussion in this group also emphasized the importance of persistence and effortful control in daily life and how these attributes can be transferred to exercise plans. Participants were encouraged to identify their threshold for exerting effort toward exercise based on past experiences and applying that awareness to their planned exercises. They were guided in creating action plans that considered not only past external barriers (e.g., schedule, fitness level, and environment) but also previous internal barriers (i.e., resistance and/or aversiveness to physical exertion) and create plans that would help them avoid repeating the same circumstances. Participants were also asked to realistically consider how much past exercise they have previously engaged in and to refine those estimates to serve as starting points for subsequent small increases in planned exercise. These group sessions lasted ~120 minutes.
11201982|NCT02204176|BG003|Baseline|Total|Total of all reporting groups
11201983|NCT02204176|FG000|Participant Flow|Exercise Information|This group was presented with information that defined and described regular exercise, its benefits, and guidance for using proper form in exercise to minimize the risk of injury. Guidelines for prescribing suggested physical activities were based on recommendations from the USDHHS (2008). These sessions lasted ~90 minutes.
11201984|NCT02204176|FG001|Participant Flow|Action Planning|This group discussed all the components from the session for the information-only group with an additional emphasis on how to create action plans. Discussions revolved around possible ways and times of the day to engage in exercise by making specific action plans that designate when, where, and how. Participants were shown how to create an example action plan and guided in writing their own exercise action plans for as many days as they desired in the three-week tracking period in their exercise booklets. Emphasis was placed on the specificity and feasibility of the plans. These sessions lasted ~120 minutes.
11201985|NCT02204176|FG002|Participant Flow|Realistic Effort Action Planning|This group discussed all components from the action planning condition. Discussion in this group also emphasized the importance of persistence and effortful control in daily life and how these attributes can be transferred to exercise plans. Participants were encouraged to identify their threshold for exerting effort toward exercise based on past experiences and applying that awareness to their planned exercises. They were guided in creating action plans that considered not only past external barriers (e.g., schedule, fitness level, and environment) but also previous internal barriers (i.e., resistance and/or aversiveness to physical exertion) and create plans that would help them avoid repeating the same circumstances. Participants were also asked to realistically consider how much past exercise they have previously engaged in and to refine those estimates to serve as starting points for subsequent small increases in planned exercise. These group sessions lasted ~120 minutes.
11201986|NCT02204176|OG000|Outcome|Exercise Information|This group was presented with information that defined and described regular exercise, its benefits, and guidance for using proper form in exercise to minimize the risk of injury. Guidelines for prescribing suggested physical activities were based on recommendations from the USDHHS (2008). These sessions lasted ~90 minutes.
11201987|NCT02204176|OG001|Outcome|Action Planning|This group discussed all the components from the session for the information-only group with an additional emphasis on how to create action plans. Discussions revolved around possible ways and times of the day to engage in exercise by making specific action plans that designate when, where, and how. Participants were shown how to create an example action plan and guided in writing their own exercise action plans for as many days as they desired in the three-week tracking period in their exercise booklets. Emphasis was placed on the specificity and feasibility of the plans. These sessions lasted ~120 minutes.
11201988|NCT02204176|OG002|Outcome|Realistic Effort Action Planning|This group discussed all components from the action planning condition. Discussion in this group also emphasized the importance of persistence and effortful control in daily life and how these attributes can be transferred to exercise plans. Participants were encouraged to identify their threshold for exerting effort toward exercise based on past experiences and applying that awareness to their planned exercises. They were guided in creating action plans that considered not only past external barriers (e.g., schedule, fitness level, and environment) but also previous internal barriers (i.e., resistance and/or aversiveness to physical exertion) and create plans that would help them avoid repeating the same circumstances. Participants were also asked to realistically consider how much past exercise they have previously engaged in and to refine those estimates to serve as starting points for subsequent small increases in planned exercise. These group sessions lasted ~120 minutes.
11201989|NCT02204176|EG000|Reported Event|Exercise Information|This group was presented with information that defined and described regular exercise, its benefits, and guidance for using proper form in exercise to minimize the risk of injury. Guidelines for prescribing suggested physical activities were based on recommendations from the USDHHS (2008). These sessions lasted ~90 minutes.
11201990|NCT02204176|EG001|Reported Event|Action Planning|This group discussed all the components from the session for the information-only group with an additional emphasis on how to create action plans. Discussions revolved around possible ways and times of the day to engage in exercise by making specific action plans that designate when, where, and how. Participants were shown how to create an example action plan and guided in writing their own exercise action plans for as many days as they desired in the three-week tracking period in their exercise booklets. Emphasis was placed on the specificity and feasibility of the plans. These sessions lasted ~120 minutes.
11202368|NCT02207244|OG001|Outcome|Adalimumab Then Guselkumab 100 mg (Week 28 - 264)|Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
11202369|NCT02207244|EG000|Reported Event|Placebo (Week 0 - 16)|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
11243167|NCT02501473|OG005|Outcome|Part 3: Local Radiation + G100 20μg/Tumor|Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243168|NCT02501473|OG006|Outcome|Part 4: G100 20μg/Tumor and Pembrolizumab 200mg|Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
11243169|NCT02501473|EG000|Reported Event|Part 1: Local Radiation + G100 5μg/Tumor|Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
11243170|NCT02501473|EG001|Reported Event|Part 1: Local Radiation + G100 10μg/Tumor|Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243171|NCT02501473|EG002|Reported Event|Part 2: Local Radiation + G100 10μg/Tumor|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243172|NCT02501473|EG003|Reported Event|Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg|Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
11243173|NCT02501473|EG004|Reported Event|Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors|Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
11243174|NCT02501473|EG005|Reported Event|Part 3: Local Radiation + G100 20μg/Tumor|Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
11243175|NCT02501473|EG006|Reported Event|Part 4: G100 20μg/Tumor and Pembrolizumab 200mg|Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
11243176|NCT02501538|BG000|Baseline|Transcutaneous O2 Device|"Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.~Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen."
11243177|NCT02501538|FG000|Participant Flow|Transcutaneous O2 Device|"Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.~Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen."
11243178|NCT02501538|OG000|Outcome|Transcutaneous O2 Device|"Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.~Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen."
11243179|NCT02501538|OG000|Outcome|Transcutaneous Oxygen Measurements|Medial and lateral foot measurements
11243180|NCT02501538|OG000|Outcome|Cytokine and Growth Factor Measurement|Measurement of cytokines
11243181|NCT02501538|OG000|Outcome|Quantitative Bacterial Cultures|Quantitative bacterial cultures by visit
11243182|NCT02501538|EG000|Reported Event|Transcutaneous O2 Device|"Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.~Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen."
11243183|NCT02501590|BG000|Baseline|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243184|NCT02501590|BG001|Baseline|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243185|NCT02501590|BG002|Baseline|Total|Total of all reporting groups
11243186|NCT02501590|FG000|Participant Flow|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243187|NCT02501590|FG001|Participant Flow|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243188|NCT02501590|OG000|Outcome|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243189|NCT02501590|OG001|Outcome|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243190|NCT02501590|EG000|Reported Event|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243191|NCT02501590|EG001|Reported Event|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand.~The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
11243192|NCT02501629|BG000|Baseline|Placebo|Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
11243193|NCT02501629|BG001|Baseline|Reslizumab 110 mg|Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
11243194|NCT02501629|BG002|Baseline|Total|Total of all reporting groups
11243195|NCT02501629|FG000|Participant Flow|Placebo|Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
11243196|NCT02501629|FG001|Participant Flow|Reslizumab 110 mg|Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
11243197|NCT02501629|OG000|Outcome|Placebo|Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
11243198|NCT02501629|OG001|Outcome|Reslizumab 110 mg|Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
11243199|NCT02501629|EG000|Reported Event|Placebo|Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
11243200|NCT02501629|EG001|Reported Event|Reslizumab 110 mg|Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
11243201|NCT02501642|BG000|Baseline|Concussion Coach Group|"After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach Explorer version~Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies"
11243202|NCT02501642|BG001|Baseline|Treatment as Usual|Treatment as usual: Treatment as usual
11243203|NCT02501642|BG002|Baseline|Total|Total of all reporting groups
11243204|NCT02501642|FG000|Participant Flow|Concussion Coach Group|"After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach Explorer version~Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies"
11243205|NCT02501642|FG001|Participant Flow|Treatment as Usual|Treatment as usual: Treatment as usual
11243206|NCT02501642|OG000|Outcome|Concussion Coach Group|"After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach Explorer version~Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies"
11243207|NCT02501642|OG001|Outcome|Treatment as Usual|Treatment as usual: Treatment as usual
11243208|NCT02501642|EG000|Reported Event|Concussion Coach Group|"After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach Explorer version~Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies"
11243209|NCT02501642|EG001|Reported Event|Treatment as Usual|Treatment as usual: Treatment as usual
11243210|NCT02501811|BG000|Baseline|MSCs + CPCs|Target dose of 150 million MSCs and 5 million CPCs
11243211|NCT02501811|BG001|Baseline|MSCs|Target dose of 150 million MSCs
11243212|NCT02501811|BG002|Baseline|CPCs|Target dose of 5 million CPCs
11243213|NCT02501811|BG003|Baseline|Placebo|Plasmalyte A
11243214|NCT02501811|BG004|Baseline|Total|Total of all reporting groups
11243215|NCT02501811|FG000|Participant Flow|MSCs + CPCs|Target dose of 150 million MSCs and 5 million CPCs
11243216|NCT02501811|FG001|Participant Flow|MSCs|Target dose of 150 million MSCs
11243217|NCT02501811|FG002|Participant Flow|CPCs|Target dose of 5 million CPCs
11243218|NCT02501811|FG003|Participant Flow|Placebo|Plasmalyte A
11243219|NCT02501811|OG000|Outcome|MSCs + CPCs|Target dose of 150 million MSCs and 5 million CPCs
11243220|NCT02501811|OG001|Outcome|MSCs|Target dose of 150 million MSCs
11243221|NCT02501811|OG002|Outcome|CPCs|Target dose of 5 million CPCs
11243222|NCT02501811|OG003|Outcome|Placebo|Plasmalyte A
11243223|NCT02501811|EG000|Reported Event|MSCs + CPCs|Target dose of 150 million MSCs and 5 million CPCs
11243224|NCT02501811|EG001|Reported Event|MSCs|Target dose of 150 million MSCs
11243225|NCT02501811|EG002|Reported Event|CPCs|Target dose of 5 million CPCs
11243226|NCT02501811|EG003|Reported Event|Placebo|Plasmalyte A
11243227|NCT02501902|BG000|Baseline|DL1 Palbociclib 75 mg/Nab-Paclitaxel 100 mg /m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-paclitaxel 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243228|NCT02501902|BG001|Baseline|DL2A Palbociclib 100mg/Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11201991|NCT02204176|EG002|Reported Event|Realistic Effort Action Planning|This group discussed all components from the action planning condition. Discussion in this group also emphasized the importance of persistence and effortful control in daily life and how these attributes can be transferred to exercise plans. Participants were encouraged to identify their threshold for exerting effort toward exercise based on past experiences and applying that awareness to their planned exercises. They were guided in creating action plans that considered not only past external barriers (e.g., schedule, fitness level, and environment) but also previous internal barriers (i.e., resistance and/or aversiveness to physical exertion) and create plans that would help them avoid repeating the same circumstances. Participants were also asked to realistically consider how much past exercise they have previously engaged in and to refine those estimates to serve as starting points for subsequent small increases in planned exercise. These group sessions lasted ~120 minutes.
11201992|NCT02204293|BG000|Baseline|Core Study Part I: Canakinumab|Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11201993|NCT02204293|BG001|Baseline|Core Study Part I: Placebo|Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11201994|NCT02204293|BG002|Baseline|Total|Total of all reporting groups
11201995|NCT02204293|FG000|Participant Flow|Core Study Part I: Canakinumab|Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11201996|NCT02204293|FG001|Participant Flow|Core Study Part I: Placebo|Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11201997|NCT02204293|FG002|Participant Flow|Core Study Part II: Canakinumab Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.
11201998|NCT02204293|FG003|Participant Flow|Core Study Part II: Placebo Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.
11201999|NCT02204293|FG004|Participant Flow|Core Study Part II: Placebo Non-responders|Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.
11202000|NCT02204293|FG005|Participant Flow|LTE Phase: Canakinumab|Participants with remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
11202001|NCT02204293|OG000|Outcome|Core Study Part I: Canakinumab|Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11202002|NCT02204293|OG001|Outcome|Core Study Part I: Placebo|Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11202003|NCT02204293|OG002|Outcome|Core Study Part II: Canakinumab Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.
11202004|NCT02204293|OG003|Outcome|Core Study Part II: Placebo Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.
11202005|NCT02204293|OG004|Outcome|Core Study Part II: Placebo Non-responders|Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.
11243229|NCT02501902|BG002|Baseline|DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243230|NCT02501902|BG003|Baseline|DL3A Palbociclib 125mg/Nab-Paclitaxel 100 mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243231|NCT02501902|BG004|Baseline|DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243232|NCT02501902|BG005|Baseline|MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
11243233|NCT02501902|BG006|Baseline|MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
11243234|NCT02501902|BG007|Baseline|MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
11243235|NCT02501902|BG008|Baseline|Total|Total of all reporting groups
11243236|NCT02501902|FG000|Participant Flow|DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
11243237|NCT02501902|FG001|Participant Flow|DL2A Palbociclib 100mg/Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243238|NCT02501902|FG002|Participant Flow|DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243239|NCT02501902|FG003|Participant Flow|DL3A Palbociclib 125mg/Nab-Paclitaxel 100 mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243240|NCT02501902|FG004|Participant Flow|DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243241|NCT02501902|FG005|Participant Flow|MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
11243242|NCT02501902|FG006|Participant Flow|MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
11243243|NCT02501902|FG007|Participant Flow|MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
11243244|NCT02501902|OG000|Outcome|DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
11243245|NCT02501902|OG001|Outcome|DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243246|NCT02501902|OG002|Outcome|DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243247|NCT02501902|OG003|Outcome|DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
11243248|NCT02501902|OG004|Outcome|DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243249|NCT02501902|OG005|Outcome|MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
11202006|NCT02204293|OG005|Outcome|LTE Phase: Canakinumab|Participants with remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
11202007|NCT02204293|EG000|Reported Event|Core Study Part I: Canakinumab|Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11202008|NCT02204293|EG001|Reported Event|Core Study Part I: Placebo|Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.
11202009|NCT02204293|EG002|Reported Event|Core Study Part II: Canakinumab Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.
10849925|NCT00299182|BG004|Baseline|1 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11202010|NCT02204293|EG003|Reported Event|Core Study Part II: Placebo Responders|Participants with response (change in DAS score > 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.
11202011|NCT02204293|EG004|Reported Event|Core Study Part II: Placebo Non-responders|Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.
11202012|NCT02204293|EG005|Reported Event|LTE Phase: Canakinumab|Participants with remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
11243250|NCT02501902|OG006|Outcome|MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
11202013|NCT02204319|BG000|Baseline|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing at each treatment visit. There was also a two week follow up scheduled for re-assessment.~Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
11202014|NCT02204319|FG000|Participant Flow|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.~Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
11202015|NCT02204319|OG000|Outcome|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.~Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
11202016|NCT02204319|OG000|Outcome|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing. There was a two week follow up scheduled for assessment.~Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
11202370|NCT02207244|EG001|Reported Event|Guselkumab 100 mg (Week 0 - 16)|Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
11202017|NCT02204319|EG000|Reported Event|Cold Laser Light Therapy|The laser unit emits three independent 7 mW, 635 nm red light diodes in a hand-held device and is a variable frequency pulsed wave device. Erchonia low level lasers have been determined safe and effective and non-significant risk (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain reduction indications, providing justification for the anticipated safety and effectiveness of application The cold laser was administered over 10 minutes as follows: 5 minutes at the area of sacral nerve roots 2-4 in the side-lying position- hertz settings: 14, 8, 12, 28; and 5 minutes at the vulva in the lithotomy position, hertz settings 2: 9,16,33,60 while the outer labia were held open by the therapist. A sweeping motion was used during administration. The laser head was positioned approximately 3 inches from the skin surface and did not touch the skin. The patient wore safety goggles while the laser treatment was provided.
11202018|NCT02204371|BG000|Baseline|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
11202019|NCT02204371|FG000|Participant Flow|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
11202020|NCT02204371|OG000|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
11202021|NCT02204371|EG000|Reported Event|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
11202022|NCT02204410|BG000|Baseline|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
11202023|NCT02204410|FG000|Participant Flow|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
11202024|NCT02204410|OG000|Outcome|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
11202025|NCT02204410|EG000|Reported Event|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
11202026|NCT02204449|BG000|Baseline|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
11202027|NCT02204449|BG001|Baseline|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
11202028|NCT02204449|BG002|Baseline|Total|Total of all reporting groups
11202029|NCT02204449|FG000|Participant Flow|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
11202030|NCT02204449|FG001|Participant Flow|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
11202031|NCT02204449|OG000|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
11202032|NCT02204449|OG001|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
11202033|NCT02204449|EG000|Reported Event|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
11202034|NCT02204449|EG001|Reported Event|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
11202035|NCT02204566|BG000|Baseline|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11202036|NCT02204566|FG000|Participant Flow|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11202037|NCT02204566|OG000|Outcome|Feasibility|Number of Participants with Acceptable Quality of Images Who Swallow the OFDI Capsule
11202038|NCT02204566|EG000|Reported Event|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.~OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system"
11202039|NCT02204579|BG000|Baseline|NPSP795|NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.
11202040|NCT02204579|FG000|Participant Flow|NPSP795|NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.
11202041|NCT02204579|OG000|Outcome|NPSP795|NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.
11202042|NCT02204579|OG000|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
11202043|NCT02204579|OG001|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
11202044|NCT02204579|OG002|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
11202045|NCT02204579|OG003|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
11202046|NCT02204579|OG004|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
11202047|NCT02204579|EG000|Reported Event|NPSP795|NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.
11202048|NCT02204657|BG000|Baseline|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
11202049|NCT02204657|BG001|Baseline|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
11202050|NCT02204657|BG002|Baseline|Total|Total of all reporting groups
11202051|NCT02204657|FG000|Participant Flow|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
11202052|NCT02204657|FG001|Participant Flow|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
11202053|NCT02204657|OG000|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
11202054|NCT02204657|OG001|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
11202371|NCT02207244|EG002|Reported Event|Adalimumab (Week 0 - 16)|Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
11243251|NCT02501902|OG007|Outcome|MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
11243252|NCT02501902|OG008|Outcome|MTD+DL3B|The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
10966497|NCT00887341|EG001|Reported Event|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
11243253|NCT02501902|OG007|Outcome|MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts
11243254|NCT02501902|OG008|Outcome|Overall Participants With Dose Normalized to 125 mg/m^2|The overall participants with dose normalized to 125 mg/m^2
11243255|NCT02501902|OG008|Outcome|Overall Participants With Dose Normalized to 125 mg/m^2.|The overall participants with dose normalized to 125 mg/m^2.
11340987|NCT03672006|OG001|Outcome|Heparin|"9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)~Heparin: Medication administered to dwell in central venous catheter"
10966498|NCT00887354|BG000|Baseline|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
11340988|NCT03672006|OG000|Outcome|Alteplase|"patients will receive 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)~alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter"
11340989|NCT03672006|OG001|Outcome|Heparin|"patients will receive 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)~Heparin: Medication administered to dwell in central venous catheter"
11340990|NCT03672006|EG000|Reported Event|Alteplase|"10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)~alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter"
11340991|NCT03672006|EG001|Reported Event|Heparin|"9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)~Heparin: Medication administered to dwell in central venous catheter"
11340992|NCT03672032|BG000|Baseline|Fork-tip Needle|Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy
11340993|NCT03672032|BG001|Baseline|Franseen Needle|Franseen Needle: Franseen Needle will be used to obtain biopsy
11340994|NCT03672032|BG002|Baseline|Total|Total of all reporting groups
11340995|NCT03672032|FG000|Participant Flow|SharkCore Needle|SharkCore Needle: SharkCore Needle will be used to obtain biopsy
11340996|NCT03672032|FG001|Participant Flow|Acquire Needle|Acquire Needle: Acquire Needle will be used to obtain biopsy
11340997|NCT03672032|OG000|Outcome|Fork-tip Needle|Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy
11340998|NCT03672032|OG001|Outcome|Franseen Needle|Franseen Needle: Fransee Needle will be used to obtain biopsy
11340999|NCT03672032|EG000|Reported Event|Fork-tip Needle|Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy
11341000|NCT03672032|EG001|Reported Event|Franseen Needle|Franseen Needle: Franseen Needle will be used to obtain biopsy
11341001|NCT03672097|BG000|Baseline|Prasugrel|Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
11341002|NCT03672097|FG000|Participant Flow|Prasugrel|Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
11341003|NCT03672097|OG000|Outcome|Prasugrel|Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
11341004|NCT03672097|EG000|Reported Event|Prasugrel|Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
11341005|NCT03672370|BG000|Baseline|Alloclassic Variall Cup|Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
11341006|NCT03672370|FG000|Participant Flow|Alloclassic Variall Cup|Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
11341007|NCT03672370|OG000|Outcome|Alloclassic Variall Cup|Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
11341008|NCT03672370|EG000|Reported Event|Alloclassic Variall Cup|Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
11341009|NCT03672396|BG000|Baseline|Home-based Exercise|"The sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour.~Home-based exercise: The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12."
11341010|NCT03672396|FG000|Participant Flow|Home-based Exercise|"The sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour.~Home-based exercise: The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12."
11341011|NCT03672396|OG000|Outcome|Home-based Exercise|"The sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour.~Home-based exercise: The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12."
10966499|NCT00887354|BG001|Baseline|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
11202055|NCT02204657|EG000|Reported Event|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
11202056|NCT02204657|EG001|Reported Event|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
11202057|NCT02204748|BG000|Baseline|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
10966500|NCT00887354|BG002|Baseline|Total|Total of all reporting groups
10966501|NCT00887354|FG000|Participant Flow|Teriparatide|"20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.~Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
10966502|NCT00887354|FG001|Participant Flow|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
11202058|NCT02204748|FG000|Participant Flow|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
10966503|NCT00887354|OG000|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
11202059|NCT02204748|OG000|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
11202060|NCT02204748|EG000|Reported Event|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
11202061|NCT02204761|BG000|Baseline|Treatment (Proton Beam Radiation Therapy)|"Patients undergo proton beam radiation therapy per standard of care.~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy"
11202062|NCT02204761|FG000|Participant Flow|Treatment (Proton Beam Radiation Therapy)|"Patients undergo proton beam radiation therapy per standard of care.~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy"
11202063|NCT02204761|OG000|Outcome|Treatment (Proton Beam Radiation Therapy)|"Patients undergo proton beam radiation therapy per standard of care.~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy"
11202064|NCT02204761|EG000|Reported Event|Treatment (Proton Beam Radiation Therapy)|"Patients undergo proton beam radiation therapy per standard of care.~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy"
11202065|NCT02204917|BG000|Baseline|ceVUS With the Use of OPTISON & VCUG in the Same Session|OPTISON will be resuspended just before the performance of ceVUS examination, and 01%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with a maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam will be performed as part of the standard care using the same bladder catheter with intravesical administration of the x-ray contrast agent.
11202066|NCT02204917|FG000|Participant Flow|ceVUS With the Use of OPTISON & VCUG in the Same Session|"OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.~VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent."
11202067|NCT02204917|OG000|Outcome|Severity of Reflux With ceVUS|Contrast enhanced Voiding Urosonography (ceVUS) OPTISON will be performed with the intravesical administration of 0.1%-0.5% OPTISON/normal saline solution. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with a maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.
11202068|NCT02204917|OG001|Outcome|Severity of Reflux With VCUG|Voiding Cystourethrography (VCUG) exam will be performed after ceVUS using the same bladder catheter with intravesical administration of the x-ray contrast agent.
11202069|NCT02204917|OG000|Outcome|ceVUS With the Use of OPTISON & VCUG in the Same Session|OPTISON will be resuspended just before the performance of ceVUS examination, 0.1%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam will be performed as part of the standard care using the same bladder catheter with intravesical administration of the x-ray contrast agent.
11202070|NCT02204917|OG000|Outcome|ceVUS With the Use of OPTISON & VCUG in the Same Session|OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with het maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam as part of the standard care will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.
11202071|NCT02204917|EG000|Reported Event|ceVUS With the Use of OPTISON & VCUG in the Same Session|"OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.~VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent."
11202072|NCT02204982|BG000|Baseline|Duvelisib + Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11202073|NCT02204982|BG001|Baseline|Placebo + Rituximab|"Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11202074|NCT02204982|BG002|Baseline|Total|Total of all reporting groups
11202075|NCT02204982|FG000|Participant Flow|Duvelisib + Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11202076|NCT02204982|FG001|Participant Flow|Placebo + Rituximab|"Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11341032|NCT03673670|OG000|Outcome|1.5 mg RPL554 and Tiotropium/Olodaterol on Day 3|"1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
10966504|NCT00887354|OG001|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
10966505|NCT00887354|OG000|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
10966506|NCT00887354|EG000|Reported Event|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
10966507|NCT00887354|EG001|Reported Event|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
10966508|NCT00887432|BG000|Baseline|Arm I (Cholecalciferol and Placebo)|"Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10966509|NCT00887432|BG001|Baseline|Arm II (Placebo and Cholecalciferol)|"Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to cholecalciferol PO QD for 9 months.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11202077|NCT02204982|OG000|Outcome|Duvelisib + Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11202078|NCT02204982|OG001|Outcome|Placebo + Rituximab|"Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11202079|NCT02204982|EG000|Reported Event|Duvelisib + Rituximab|"Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
10966510|NCT00887432|BG002|Baseline|Total|Total of all reporting groups
11202372|NCT02207244|EG003|Reported Event|Placebo Then Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
11202080|NCT02204982|EG001|Reported Event|Placebo + Rituximab|"Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.~Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.~Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.~Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10."
11243256|NCT02501902|EG000|Reported Event|DL1 Palbociclib 75mg / Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
11243257|NCT02501902|EG001|Reported Event|DL2A Palbociclib 100mg / Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
10850882|NCT04262947|FG001|Participant Flow|VeinViewer Visualization Only|"Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement~Conventional IV placement: IV placement utilizing conventional methods"
10850883|NCT04262947|FG002|Participant Flow|Constant Imaging With VeinViewer|"Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer~Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement"
10849926|NCT00299182|BG005|Baseline|3 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
11202373|NCT02207244|EG004|Reported Event|Guselkumab 100 mg (Week 16 - 28)|Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
10850884|NCT04262947|OG000|Outcome|Conventional Method|"Placement of peripheral venous catheter using conventional methods~Conventional IV placement: IV placement utilizing conventional methods"
11243258|NCT02501902|EG002|Reported Event|DL2B Palbociclib 75mg / Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11202374|NCT02207244|EG005|Reported Event|Adalimumab (Week 16 - 28)|Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
11341033|NCT03673670|OG001|Outcome|6 mg RPL554 and Tiotropium/Olodaterol on Day 3|"6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341034|NCT03673670|OG002|Outcome|Placebo and Tiotropium/Olodaterol on Day 3|"Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~Placebo: A placebo solution~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341035|NCT03673670|OG000|Outcome|1.5 mg RPL554 and Tiotropium/Oldaterol on Day 3|"1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341036|NCT03673670|OG001|Outcome|6 mg RPL554 and Tiotropium/Oldaterol on Day 3|"6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341037|NCT03673670|OG002|Outcome|Placebo and Tiotropium/Oldaterol on Day 3|"Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~Placebo: A placebo solution~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341038|NCT03673670|EG000|Reported Event|1.5 mg RPL554 and Tiotropium/Olodaterol|"1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341039|NCT03673670|EG001|Reported Event|6 mg RPL554 and Tiotropium/Olodaterol|"6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341040|NCT03673670|EG002|Reported Event|Placebo and Tiotropium/Olodaterol|"Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~Placebo: A placebo solution~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341041|NCT03674177|BG000|Baseline|RSV MAT Formulation 1 Group|Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341042|NCT03674177|BG001|Baseline|RSV MAT Formulation 2 Group|Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341043|NCT03674177|BG002|Baseline|RSV MAT Formulation 3 Group|Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341044|NCT03674177|BG003|Baseline|Control Group|Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341045|NCT03674177|BG004|Baseline|Total|Total of all reporting groups
11341046|NCT03674177|FG000|Participant Flow|RSV MAT Formulation 1 Group|Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341047|NCT03674177|FG001|Participant Flow|RSV MAT Formulation 2 Group|Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341048|NCT03674177|FG002|Participant Flow|RSV MAT Formulation 3 Group|Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341049|NCT03674177|FG003|Participant Flow|Control Group|Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341050|NCT03674177|OG000|Outcome|RSV MAT Formulation 1 Group|Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341051|NCT03674177|OG001|Outcome|RSV MAT Formulation 2 Group|Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341052|NCT03674177|OG002|Outcome|RSV MAT Formulation 3 Group|Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341053|NCT03674177|OG003|Outcome|Control Group|Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341054|NCT03674177|EG000|Reported Event|RSV MAT Formulation 1 Group|Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341055|NCT03674177|EG001|Reported Event|RSV MAT Formulation 2 Group|Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341056|NCT03674177|EG002|Reported Event|RSV MAT Formulation 3 Group|Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341057|NCT03674177|EG003|Reported Event|Control Group|Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
11341088|NCT03674970|OG002|Outcome|Placebo Control|"One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11243259|NCT02501902|EG003|Reported Event|DL3A Palbociclib 125mg / Nab-Paclitaxel 100mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11341137|NCT03676634|FG000|Participant Flow|0.5 mL rBV A/B|A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
11341138|NCT03676634|OG000|Outcome|0.5 mL rBV A/B|A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
11341139|NCT03676634|EG000|Reported Event|0.5 mL rBV A/B|A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
11341140|NCT03676725|BG000|Baseline|Males Without ADHD|ADHD-RS <18
11341141|NCT03676725|BG001|Baseline|Males With ADHD|ADHD-RS ≥18
11341142|NCT03676725|BG002|Baseline|Females Without ADHD and Without PMS|ADHD-RS <18 and Custom PMS <12
11341143|NCT03676725|BG003|Baseline|Females Without ADHD, But With PMS|ADHD-RS <18 and Custom PMS ≥12
11341144|NCT03676725|BG004|Baseline|Females With ADHD and Without PMS|ADHD-RS ≥18 and Custom PMS <12
11341145|NCT03676725|BG005|Baseline|Females With ADHD and With PMS|ADHD-RS ≥18 and Custom PMS ≥12
11341146|NCT03676725|BG006|Baseline|Total|Total of all reporting groups
11341147|NCT03676725|FG000|Participant Flow|Males Without ADHD|"Arm 1~Lidocaine gel: Lidocaine gel 5%"
11341148|NCT03676725|FG001|Participant Flow|Males With ADHD|"Arm 2~Lidocaine gel: Lidocaine gel 5%"
11341149|NCT03676725|FG002|Participant Flow|Females Without ADHD and Without PMS|"Arm 3~Lidocaine gel: Lidocaine gel 5%"
11341150|NCT03676725|FG003|Participant Flow|Females Without ADHD, But With PMS|"Arm 4~Lidocaine gel: Lidocaine gel 5%"
11341151|NCT03676725|FG004|Participant Flow|Females With ADHD and Without PMS|"Arm 5~Lidocaine gel: Lidocaine gel 5%"
11341152|NCT03676725|FG005|Participant Flow|Females With ADHD and With PMS|"Arm 6~Lidocaine gel: Lidocaine gel 5%"
11341153|NCT03676725|OG000|Outcome|Males Without ADHD|ADHD-RS <18
11341154|NCT03676725|OG001|Outcome|Males With ADHD|ADHD-RS ≥18
11341155|NCT03676725|OG002|Outcome|Females Without ADHD and Without PMS|ADHD-RS <18 and Custom PMS <12
11341156|NCT03676725|OG003|Outcome|Females Without ADHD, But With PMS|ADHD-RS <18 and Custom PMS ≥12
11341157|NCT03676725|OG004|Outcome|Females With ADHD and Without PMS|ADHD-RS ≥18 and Custom PMS <12
11341158|NCT03676725|OG005|Outcome|Females With ADHD and With PMS|ADHD-RS ≥18 and Custom PMS ≥12
11341159|NCT03676725|EG000|Reported Event|All Subjects|All subjects were monitored as a single group for adverse reactions
11341160|NCT03676803|BG000|Baseline|Mixed Spices Intervention Group|"Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose~Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g."
11341161|NCT03676803|BG001|Baseline|Placebo Group|"Healthy participants consume placebo capsule containing 5 g of maltodextrin~Placebo capsules contain 5 g maltodextrin."
11341162|NCT03676803|BG002|Baseline|Total|Total of all reporting groups
11341163|NCT03676803|FG000|Participant Flow|Mixed Spices Intervention Group|"Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose~Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g. They are identical to herbs and spices sold in grocery stores for human consumption."
11341164|NCT03676803|FG001|Participant Flow|Placebo Group|"Healthy participants consume placebo capsule containing 5 g of maltodextrin~Placebo capsules contain 5 g maltodextrin."
11341165|NCT03676803|OG000|Outcome|Mixed Spices Intervention Group|Healthy participants consume a capsule containing 5 g of mixed spices daily for 2 weeks
11341166|NCT03676803|OG001|Outcome|Placebo Group|Healthy participants consumed placebo capsules daily for 2 weeks.
11341167|NCT03676803|OG000|Outcome|Mixed Spices Intervention Group|Healthy participants consumed 5 g of mixed spices daily for 2 weeks
11341168|NCT03676803|OG001|Outcome|Placebo Group|Healthy participants consumed placebo capsules containing 5 g of maltodextrin daily for 2 weeks
11341169|NCT03676803|EG000|Reported Event|Mixed Spices Intervention Group|"Healthy participants consume a capsule containing 5 g of mixed spices at culinary dose~Mixed spice capsules contain 1 g cinnamon, 1.5 g oregano, 1.5 g ginger, 0.85g black pepper and 0.15g cayenne pepper for a total of 5.0 g."
11341170|NCT03676803|EG001|Reported Event|Placebo Group|"Healthy participants consume placebo capsule containing 5 g of maltodextrin~Placebo capsules contain 5 g maltodextrin."
11341171|NCT03676972|BG000|Baseline|LithoVue Ureteroscope System|"The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.~LithoVue Ureteroscope System: The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes."
11341172|NCT03676972|FG000|Participant Flow|LithoVue Ureteroscope System|"The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.~LithoVue Ureteroscope System: The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes."
11243260|NCT02501902|EG004|Reported Event|DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
11243261|NCT02501902|EG005|Reported Event|MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2|This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
11243262|NCT02501902|EG006|Reported Event|MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2|This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
11202081|NCT02205177|BG000|Baseline|Face-to-Face w/ Anxiety Coach (FTF-AC)|"Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly & within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, & review progress in-session via the web-based portal.~Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication."
11202082|NCT02205177|BG001|Baseline|Minimal Contact w/ Anxiety Coach (MC-AC)|"Therapist's will meet with the patient & parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal & communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention.~Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication."
11202083|NCT02205177|BG002|Baseline|Total|Total of all reporting groups
11202084|NCT02205177|FG000|Participant Flow|Face-to-Face w/ Anxiety Coach (FTF-AC)|"In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, & review progress in-session via the web-based portal.~Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence & theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging"
11202085|NCT02205177|FG001|Participant Flow|Minimal Contact w/ Anxiety Coach (MC-AC)|"In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 & up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.~Mayo Clinic Anxiety Coach: Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communicatio"
11202086|NCT02205177|OG000|Outcome|Face-to-Face w/ Anxiety Coach (FTF-AC)|In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.
11243263|NCT02501902|EG007|Reported Event|MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2|The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
11243264|NCT02501902|EG008|Reported Event|MTD+DL3B|The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all patients from the MTD cohort.
11243265|NCT02501928|BG000|Baseline|Fesoterodine 8 mg Tablet|Japanese participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and for 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
11243266|NCT02501928|BG001|Baseline|Fesoterodine 2 mg Capsule|Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243267|NCT02501928|BG002|Baseline|Fesoterodine 4 mg Capsule|Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243268|NCT02501928|BG003|Baseline|Total|Total of all reporting groups
11243269|NCT02501928|FG000|Participant Flow|Fesoterodine 4 Milligram (mg) Tablet|In precedent study A0221047, participants of cohort 1, with body weight greater than (>) 25 kilogram (kg), received fesoterodine 4 mg prolonged release (PR) tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 28 weeks in this LTE study.
11243270|NCT02501928|FG001|Participant Flow|Fesoterodine 8 mg Tablet|In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
11243271|NCT02501928|FG002|Participant Flow|Oxybutynin Then Fesoterodine 4 mg Tablet|In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet in safety extension phase once daily for 12 weeks. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 40 weeks in this LTE study.
11243272|NCT02501928|FG003|Participant Flow|Oxybutynin Then Fesoterodine 8 mg Tablet|In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet once daily for 1 week and if tolerated well received 8 mg PR tablet once daily for 11 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 40 weeks in this LTE study.
10849927|NCT00299182|BG006|Baseline|10 mcg/ kg AMG531 Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849928|NCT00299182|BG007|Baseline|Total|Total of all reporting groups
10849929|NCT00299182|FG000|Participant Flow|1 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849930|NCT00299182|FG001|Participant Flow|3 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849931|NCT00299182|FG002|Participant Flow|10 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10850271|NCT00301067|OG003|Outcome|Expansion - Temozolomide and Calcitriol|"Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.~Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.~Calcitriol: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle~Temozolomide: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle"
11243273|NCT02501928|FG004|Participant Flow|Fesoterodine 2 mg Capsule|In precedent study A0220147, participants of cohort 2, with body weight less than or equal to (<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243274|NCT02501928|FG005|Participant Flow|Fesoterodine 4 mg Capsule|In precedent study A0221047, participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
10966511|NCT00887432|FG000|Participant Flow|Cholecalciferol to Placebo|"Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10966512|NCT00887432|FG001|Participant Flow|Placebo to Cholecalciferol|"Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Cholecalciferol PO QD for 9 months.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10966513|NCT00887432|OG000|Outcome|Cholecalciferol|"Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10849932|NCT00299182|FG003|Participant Flow|Placebo (Arm A & Arm B) With Chemotherapy|"Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy~Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10966514|NCT00887432|OG001|Outcome|Placebo|"Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11243275|NCT02501928|OG000|Outcome|Cohort 1|Participants of cohort 1 with body weight >25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
11202087|NCT02205177|OG001|Outcome|Minimal Contact w/ Anxiety Coach (MC-AC)|In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
11243276|NCT02501928|OG001|Outcome|Cohort 2|Participants of cohort 2 with body weight <=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
11243277|NCT02501928|OG002|Outcome|Fesoterodine 8 mg Tablet|Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
11202088|NCT02205177|EG000|Reported Event|Face-to-Face w/ Anxiety Coach (FTF-AC)|"Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly & within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, & review progress in-session via the web-based portal.~Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication."
11202089|NCT02205177|EG001|Reported Event|Minimal Contact w/ Anxiety Coach (MC-AC)|"Therapist's will meet with the patient & parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal & communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention.~Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication."
11202090|NCT02205307|BG000|Baseline|PINPOINT or SPY Elite|A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
11202091|NCT02205307|BG001|Baseline|STANDARD|A low anterior resection will be performed according to the surgeon's standard practice
10966515|NCT00887432|EG000|Reported Event|Cholecalciferol|"Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11202092|NCT02205307|BG002|Baseline|Total|Total of all reporting groups
11202093|NCT02205307|FG000|Participant Flow|PINPOINT or SPY Elite|A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
11202094|NCT02205307|FG001|Participant Flow|STANDARD|A low anterior resection will be performed according to the surgeon's standard practice
11202095|NCT02205307|OG000|Outcome|PINPOINT or SPY Elite|A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
11202096|NCT02205307|OG001|Outcome|STANDARD|A low anterior resection will be performed according to the surgeon's standard practice
10966516|NCT00887432|EG001|Reported Event|Placebo|"Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.~Cholecalciferol: Given PO~Laboratory Biomarker Analysis: Correlative studies~Patient Observation~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
10966517|NCT00887458|BG000|Baseline|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
10966518|NCT00887458|BG001|Baseline|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
10966519|NCT00887458|BG002|Baseline|Total|Total of all reporting groups
10966520|NCT00887458|FG000|Participant Flow|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
10966521|NCT00887458|FG001|Participant Flow|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
10966522|NCT00887458|OG000|Outcome|Low Dose Itraconazole|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
10966523|NCT00887458|OG001|Outcome|High Dose Itraconazole|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
10966524|NCT00887458|OG000|Outcome|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
10966525|NCT00887458|OG001|Outcome|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
10966526|NCT00887458|EG000|Reported Event|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
10966527|NCT00887458|EG001|Reported Event|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
10966528|NCT00887471|BG000|Baseline|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
10966529|NCT00887471|BG001|Baseline|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
10966530|NCT00887471|BG002|Baseline|Total|Total of all reporting groups
10966531|NCT00887471|FG000|Participant Flow|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
10966532|NCT00887471|FG001|Participant Flow|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
10966533|NCT00887471|OG000|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
10966534|NCT00887471|OG001|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
10966535|NCT00887471|EG000|Reported Event|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
10966536|NCT00887471|EG001|Reported Event|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
11202097|NCT02205307|EG000|Reported Event|PINPOINT or SPY Elite|A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
11202098|NCT02205307|EG001|Reported Event|STANDARD|A low anterior resection will be performed according to the surgeon's standard practice
11202099|NCT02205307|EG002|Reported Event|Not Treated|Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.
10800405|NCT00669669|OG000|Outcome|Treatment (Chemotherapy, Autologous Stem Cell Transplant)|"See Detailed Description~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Carmustine: Given IV~Filgrastim: Given SC~In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT~Laboratory Biomarker Analysis: Correlative studies~O6-Benzylguanine: Given IV~Plerixafor: Given SC~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy~Temozolomide: Given PO"
10800406|NCT00669669|EG000|Reported Event|Treatment (Chemotherapy, Autologous Stem Cell Transplant)|"See Detailed Description~3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Carmustine: Given IV~Filgrastim: Given SC~In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant~Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT~Laboratory Biomarker Analysis: Correlative studies~O6-Benzylguanine: Given IV~Plerixafor: Given SC~Proton Beam Radiation Therapy: Undergo proton beam radiation therapy~Temozolomide: Given PO"
10800407|NCT00549848|BG000|Baseline|PEG 3500 Units/m^2|Patients randomized on the first day of continuation phase to receive 3500 units/m^2 dose of PEG-asparaginase
10800408|NCT00549848|BG001|Baseline|PEG 2500 Units/m^2|Patients randomized on the first day of continuation phase to receive 2,500 units/m^2 dose of PEG-asparaginase
10800409|NCT00549848|BG002|Baseline|Not Randomized|Patients who came off study prior to randomization
10800410|NCT00549848|BG003|Baseline|Total|Total of all reporting groups
10800411|NCT00549848|FG000|Participant Flow|PEG 3500 Units/m^2|Patients randomized on the first day of continuation phase to receive 3500 units/m^2 dose of PEG-asparaginase
10800412|NCT00549848|FG001|Participant Flow|PEG 2500 Units/m^2|Patients randomized on the first day of continuation phase to receive 2,500 units/m^2 dose of PEG-asparaginase
10800413|NCT00549848|FG002|Participant Flow|Not Randomized|Patients who came off study prior to randomization
10800414|NCT00549848|OG000|Outcome|PEG 3500 Units/m^2|Patients randomized on the first day of continuation phase to receive 3500 units/m^2 dose of PEG-asparaginase
10800415|NCT00549848|OG001|Outcome|PEG 2500 Units/m^2|Patients randomized on the first day of continuation phase to receive 2,500 units/m^2 dose of PEG-asparaginase
10800416|NCT00549848|OG000|Outcome|TOTXVI PEG 3500|Patients randomized on the first day of continuation phase to receive 3500 units/m^2 dose of PEG-asparaginase
10800417|NCT00549848|OG001|Outcome|TOTXVI PEG 2500|Patients randomized on the first day of continuation phase to receive 2,500 units/m^2 dose of PEG-asparaginase
10800418|NCT00549848|OG002|Outcome|TOTXVI Not Randomized|Patients who came off study prior to randomization
10800419|NCT00549848|OG003|Outcome|All Eligible Patients in TOTXV|All 498 eligible children with ALL who are treated with risk-directed therapy.
10800420|NCT00549848|OG002|Outcome|TOTVI Not Randomized|Patients who came off study prior to randomization
10800421|NCT00549848|OG003|Outcome|All Eligible Patients in TOTXV|All eligible children with ALL who are treated with risk-directed therapy.
10800422|NCT00549848|OG003|Outcome|All Eligible Patients in TOTXV|Eligible Patients in TOTXV
10800423|NCT00549848|OG003|Outcome|All Eligible Patients in TOTXV|Day 15 MRD > or equal to 5% in Total XV
10800424|NCT00549848|OG003|Outcome|All Eligible Patients in TOTXV|Patients with features associated with increased risk for CNS relapse in Total XV
10800425|NCT00549848|EG000|Reported Event|PEG 3500 Units/m^2|Patients randomized on the first day of continuation phase to receive 3500 units/m^2 dose of PEG-asparaginase
10800426|NCT00549848|EG001|Reported Event|PEG 2500 Units/m^2|Patients randomized on the first day of continuation phase to receive 2,500 units/m^2 dose of PEG-asparaginase
10800427|NCT00549848|EG002|Reported Event|Not Randomized|Patients who came off study prior to randomization
10966537|NCT00887484|BG000|Baseline|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
11202100|NCT02205333|BG000|Baseline|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
11202101|NCT02205333|BG001|Baseline|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
11202102|NCT02205333|BG002|Baseline|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
11202103|NCT02205333|BG003|Baseline|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
11202104|NCT02205333|BG004|Baseline|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
11202105|NCT02205333|BG005|Baseline|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202106|NCT02205333|BG006|Baseline|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
10966538|NCT00887484|FG000|Participant Flow|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
10966539|NCT00887484|OG000|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
10966540|NCT00887484|OG001|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
11202107|NCT02205333|BG007|Baseline|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202108|NCT02205333|BG008|Baseline|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202109|NCT02205333|BG009|Baseline|Total|Total of all reporting groups
10966541|NCT00887484|OG000|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
10966542|NCT00887484|OG001|Outcome|Epiduo|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
11243278|NCT02501928|OG003|Outcome|Fesoterodine 2 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243279|NCT02501928|OG004|Outcome|Fesoterodine 4 mg Capsule|Participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
11243280|NCT02501928|OG005|Outcome|Total of Treatment Groups|Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
11243281|NCT02501928|OG000|Outcome|Fesoterodine 8 mg Tablet|Participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
10966543|NCT00887484|OG000|Outcome|All Subjects|Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
10966544|NCT00887484|OG000|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
10966545|NCT00887484|EG000|Reported Event|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
10966546|NCT00887510|BG000|Baseline|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
10966547|NCT00887510|BG001|Baseline|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
10966548|NCT00887510|BG002|Baseline|Total|Total of all reporting groups
11202110|NCT02205333|FG000|Participant Flow|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
11202111|NCT02205333|FG001|Participant Flow|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
11202112|NCT02205333|FG002|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
11202113|NCT02205333|FG003|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
11202114|NCT02205333|FG004|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
11202115|NCT02205333|FG005|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202116|NCT02205333|FG006|Participant Flow|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202117|NCT02205333|FG007|Participant Flow|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202118|NCT02205333|FG008|Participant Flow|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202119|NCT02205333|OG000|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
11202120|NCT02205333|OG001|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
11202121|NCT02205333|OG002|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
11202122|NCT02205333|OG003|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
11202123|NCT02205333|OG004|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
11202124|NCT02205333|OG005|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202125|NCT02205333|OG006|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202126|NCT02205333|OG007|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202127|NCT02205333|OG008|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202128|NCT02205333|EG000|Reported Event|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
11202129|NCT02205333|EG001|Reported Event|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
11202130|NCT02205333|EG002|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
11202131|NCT02205333|EG003|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
11202132|NCT02205333|EG004|Reported Event|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
11202133|NCT02205333|EG005|Reported Event|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202134|NCT02205333|EG006|Reported Event|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
11202135|NCT02205333|EG007|Reported Event|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202136|NCT02205333|EG008|Reported Event|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
11202137|NCT02205476|BG000|Baseline|Group 1: PF--06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11202138|NCT02205476|BG001|Baseline|Group 2: PF--06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11202139|NCT02205476|BG002|Baseline|Total|Total of all reporting groups
11202140|NCT02205476|FG000|Participant Flow|Group 1: PF--06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11202141|NCT02205476|FG001|Participant Flow|Group 2: PF--06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11202142|NCT02205476|OG000|Outcome|Group 1: PF--06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
11202143|NCT02205476|OG001|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
11202144|NCT02205476|OG002|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
10966549|NCT00887510|FG000|Participant Flow|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
11202376|NCT02207244|EG007|Reported Event|Guselkumab 100 mg (Week 28 - 264)|Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
11202377|NCT02207244|EG008|Reported Event|Adalimumab Then Guselkumab 100 mg (Week 28 - 264)|Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 36 and q8w through Week 72. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252. The presentation of data from the adalimumab group from Week 28 to Week 264 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 264) and adalimumab (After ACP) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).
11202378|NCT02207244|EG009|Reported Event|Adalimumab (After ACP)|Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of >=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
11202379|NCT02207322|BG000|Baseline|Standard Transplant Care|"Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)~-- Complete baseline data collection, and registration~Patient Randomization~Standard transplant oncology care~-- Palliative care consults only upon request~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT"
11202380|NCT02207322|BG001|Baseline|Transplant With Early Palliative Care|"Standard transplant oncology care with early palliative care~Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)~--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT~transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation"
11202381|NCT02207322|BG002|Baseline|Total|Total of all reporting groups
11202382|NCT02207322|FG000|Participant Flow|Standard Transplant Care|"Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)~-- Complete baseline data collection, and registration~Patient Randomization~Standard transplant oncology care~-- Palliative care consults only upon request~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT"
11202383|NCT02207322|FG001|Participant Flow|Transplant With Early Palliative Care|"Standard transplant oncology care with early palliative care~Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)~--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT~transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation"
11202384|NCT02207322|OG000|Outcome|Standard Transplant Care|"Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)~-- Complete baseline data collection, and registration~Patient Randomization~Standard transplant oncology care~-- Palliative care consults only upon request~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT"
11202385|NCT02207322|OG001|Outcome|Transplant With Early Palliative Care|"Standard transplant oncology care with early palliative care~Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)~--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT~transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation"
11202386|NCT02207322|EG000|Reported Event|Standard Transplant Care|"Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital)~-- Complete baseline data collection, and registration~Patient Randomization~Standard transplant oncology care~-- Palliative care consults only upon request~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT"
11202387|NCT02207322|EG001|Reported Event|Transplant With Early Palliative Care|"Standard transplant oncology care with early palliative care~Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)~--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits~Longitudinal Data Collection (patient & family caregivers)~Week-2 of hospitalization~3-months, and 6-months post HSCT~transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation"
11286121|NCT02883452|OG001|Outcome|Arm 1: CT-P13 IV 5 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
10847456|NCT00283296|OG000|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
11243325|NCT02502149|OG000|Outcome|2K/15K rFVIIIFc (1000/6000 IU/Vial Strength)- All Participants|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for PK1. At PK1, participants were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11243326|NCT02502149|OG000|Outcome|15K rFVIIIFc (1000 and 6000 IU/Vial Strength)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11243327|NCT02502149|EG000|Reported Event|2K rFVIIIFc (1000 IU/Vial Strength) (PK1)|All participants received rFVIIIFc (1000 IU/vial strength), 50 IU/kg, manufactured in 2K (2000 liter bioreactor scale) for pharmacokinetic assessment 1 (PK1).
11243328|NCT02502149|EG001|Reported Event|15K rFVIIIFc (1000 and 6000 IU/Vial Strength)|Participants who received 2K rFVIIIFc 1000 IU/vial (50 IU/kg) for PK1 were randomized to receive rFVIIIFc (1000 or 6000 IU/vial strength), 50 IU/kg, manufactured in 15K (15000 liter bioreactor scale) for PK2. Following PK2 assessments, participants received prophylactic treatment with any of 5 available 15K vial strengths during the treatment phase. After 13 weeks of treatment with 15K rFVIIIFc, participants were re-evaluated at PK3 at the same vial strength as in PK2. A minimum of 120 hours of washout was observed prior to the PK2 assessment. Following the PK3 assessment, participants were resumed to treatment in the Treatment Period until they complete a total of at least 26 weeks of treatment.
11243329|NCT02502461|BG000|Baseline|Standard Care|Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
11243330|NCT02502461|BG001|Baseline|Cuff Palpation|"Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.~cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch."
11243331|NCT02502461|BG002|Baseline|Total|Total of all reporting groups
11243332|NCT02502461|FG000|Participant Flow|Standard Care|"Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.~cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch."
11243333|NCT02502461|FG001|Participant Flow|Cuff Palpation|"Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.~cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch."
11243334|NCT02502461|OG000|Outcome|Standard Care|Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
11243335|NCT02502461|OG001|Outcome|Cuff Palpation|"Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.~cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch."
11243336|NCT02502461|EG000|Reported Event|Standard Care|Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
11243337|NCT02502461|EG001|Reported Event|Cuff Palpation|"Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.~cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch."
11243338|NCT02502487|BG000|Baseline|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243339|NCT02502487|BG001|Baseline|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
11243340|NCT02502487|BG002|Baseline|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243341|NCT02502487|BG003|Baseline|Total|Total of all reporting groups
11243342|NCT02502487|FG000|Participant Flow|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243343|NCT02502487|FG001|Participant Flow|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
11243344|NCT02502487|FG002|Participant Flow|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243345|NCT02502487|OG000|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243346|NCT02502487|OG001|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
11243347|NCT02502487|OG002|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
11243348|NCT02502487|EG000|Reported Event|Tetracaine Group|tetracaine gel plus DPNB with saline
11243349|NCT02502487|EG001|Reported Event|DPNB Group|DPNB with ropivacaine plus plain lubricant
11243350|NCT02502487|EG002|Reported Event|Combination Group|DPNB with ropivacaine plus tetracaine gel
11243351|NCT02502526|BG000|Baseline|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243352|NCT02502526|BG001|Baseline|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243353|NCT02502526|BG002|Baseline|IVS MFK|IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243354|NCT02502526|BG003|Baseline|Total|Total of all reporting groups
11243355|NCT02502526|FG000|Participant Flow|CVS Bal|Centurion® Vision System (CVS), 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243356|NCT02502526|FG001|Participant Flow|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243357|NCT02502526|FG002|Participant Flow|IVS MFK|lnfiniti® Vision System (IVS), 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243358|NCT02502526|OG000|Outcome|CVS Bal|CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243359|NCT02502526|OG001|Outcome|IVS MFK|lVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243360|NCT02502526|OG001|Outcome|CVS MFK|CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243361|NCT02502526|OG002|Outcome|IVS MFK|IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
11243362|NCT02502526|EG000|Reported Event|CVS Bal|Subjects exposed to CVS, 45° Balanced Tip
11243363|NCT02502526|EG001|Reported Event|CVS MFK|Subjects exposed to CVS, 45° MFK Tip
11243364|NCT02502526|EG002|Reported Event|IVS MFK|Subjects exposed to lVS, 45° MFK Tip
11243365|NCT02502734|BG000|Baseline|Fluticasone Furoate and Placebo in Any of the Two Sequences|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
11286122|NCT02883452|EG000|Reported Event|Cohort 1: CT-P13 IV 5 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
11202388|NCT02207374|BG000|Baseline|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
10847457|NCT00283296|EG000|Reported Event|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
10847458|NCT00283387|BG000|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and betaine first.
11202389|NCT02207374|BG001|Baseline|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202390|NCT02207374|BG002|Baseline|Additional OAD|Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.
11202391|NCT02207374|BG003|Baseline|Total|Total of all reporting groups
11202392|NCT02207374|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202393|NCT02207374|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202394|NCT02207374|FG002|Participant Flow|Additional OAD|Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.
11202395|NCT02207374|OG000|Outcome|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202396|NCT02207374|OG001|Outcome|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11215309|NCT02298192|EG001|Reported Event|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
11092482|NCT01540266|BG001|Baseline|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092483|NCT01540266|BG002|Baseline|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11202397|NCT02207374|OG002|Outcome|Additional OAD|Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.
11215310|NCT02298322|BG000|Baseline|CoolSculpting Treatment|Subjects treated with CoolSculpting for fat reduction in the submittal area
10804037|NCT04388319|EG000|Reported Event|Combination Zonisamide and Bupropion With E-cigarette|"Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide and bupropion in addition to continued use of the G6. Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.~Zonisamide: Zonisamide (100 mg/daily) for 12 weeks.~Bupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.~Halo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day."
10804038|NCT04358549|BG000|Baseline|Favipiravir Treatment Arm|"Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC~Favipiravir: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets"
10804039|NCT04358549|BG001|Baseline|Standard of Care Arm|"Standard of Care for 14 days~Standard of Care: Standard of Care for individual study site as determined by each hospital's protocol"
10804040|NCT04358549|BG002|Baseline|Total|Total of all reporting groups
10804041|NCT04358549|FG000|Participant Flow|Favipiravir Treatment Arm|"Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC~Favipiravir: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets"
10804042|NCT04358549|FG001|Participant Flow|Standard of Care Arm|"Standard of Care for 14 days~Standard of Care: Standard of Care for individual study site as determined by each hospital's protocol"
10804043|NCT04358549|OG000|Outcome|Favipiravir Treatment Arm|"Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC~Favipiravir: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets"
10804044|NCT04358549|OG001|Outcome|Standard of Care Arm|"Standard of Care for 14 days~Standard of Care: Standard of Care for individual study site as determined by each hospital's protocol"
10804045|NCT04358549|EG000|Reported Event|Favipiravir Treatment Arm|"Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC~Favipiravir: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets"
10804046|NCT04358549|EG001|Reported Event|Standard of Care Arm|"Standard of Care for 14 days~Standard of Care: Standard of Care for individual study site as determined by each hospital's protocol"
10804047|NCT04229888|BG000|Baseline|Subject Treatment|All subjects will receive light based treatment, then all subjects will receive LipiFlow treatment.
10804048|NCT04229888|FG000|Participant Flow|Subject Treatment|All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
10804049|NCT04229888|OG000|Outcome|Subjects Treatment Light Based (Sham)|"All subjects will receive light based (sham) treatment.~Light Based Treatment: A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment."
10804050|NCT04229888|OG001|Outcome|Subjects Treatment LipiFlow|"All subjects will receive LipiFlow treatment.~LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content"
10804051|NCT04229888|OG000|Outcome|Subjects Treatment Light Based (Sham)|"All subjects will receive light based (sham) treatment.~Light Based Treatment: A light based treatment will be used to compare effectiveness to the LipiFlow treatment."
10804052|NCT04229888|EG000|Reported Event|Light Based (Sham) Treatment|All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
10804053|NCT04229888|EG001|Reported Event|LipiFlow Treatment|All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
10804054|NCT04221828|BG000|Baseline|NanoPac|"Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.~NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation."
10820432|NCT00057876|OG001|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
11215311|NCT02298322|FG000|Participant Flow|CoolSculpting Treatment|Subjects treated with Coolsculpting for subcutaneous fat reduction in the submental area
11202398|NCT02207374|EG000|Reported Event|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly 0.5 mg maintenance dose for 52 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202399|NCT02207374|EG001|Reported Event|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a period up to 56 weeks. The treatment period was divided into the dose escalation and the dose maintenance period. Subjects followed a fixed dose escalation pattern to mitigate tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to once weekly doses of 0.5 mg for 4 weeks, and finally escalated to once weekly 1.0 mg maintenance dose for 48 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. All subjects continued their pre-trial treatment of either diet and exercise therapy or OAD monotherapy in addition to diet and exercise throughout the trial.
11202400|NCT02207374|EG002|Reported Event|Additional OAD|Subjects were randomised to receive one additional OAD in addition to the pre-trial treatment for a duration of 56 weeks. The type and dosage of the additional OAD was selected by the investigator according to the approved Japanese labelling based on drug combinations and contraindications. One of the following OADs was to be selected as the additional OAD therapy: dipeptidyl peptidase-4 (DPP-4) inhibitor, SU, glinide, biguanide, α-GI and TZD. For subjects treated with OAD as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD was to be chosen. The dose of the additional OAD was optimized within approved Japanese labelling until week 8 (dose adjustment period) and the dose remained unchanged until week 56 (maintenance dose) unless rescue medication was needed. The type of the additional OAD remained unchanged during the trial.
11202401|NCT02207400|BG000|Baseline|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202402|NCT02207400|BG001|Baseline|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202403|NCT02207400|BG002|Baseline|Total|Total of all reporting groups
11202404|NCT02207400|FG000|Participant Flow|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202405|NCT02207400|FG001|Participant Flow|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202406|NCT02207400|OG000|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202407|NCT02207400|OG001|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202408|NCT02207400|OG000|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
11202409|NCT02207400|OG000|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
11202410|NCT02207400|OG000|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
11202411|NCT02207400|EG000|Reported Event|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
11202412|NCT02207400|EG001|Reported Event|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202413|NCT02207413|BG000|Baseline|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202414|NCT02207413|BG001|Baseline|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202415|NCT02207413|BG002|Baseline|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202416|NCT02207413|BG003|Baseline|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11215312|NCT02298322|OG000|Outcome|CoolSculpting Treatment|Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
11215313|NCT02298322|OG000|Outcome|CoolSculpting Treatment|Per-protocol subjects treated with CoolSculpting for fat reduction in the submental area
11215314|NCT02298322|OG000|Outcome|CoolSculpting Treatment|Subjects with CoolSculpting treatment for subcutaneous fat reduction of the submental area
10804055|NCT04221828|FG000|Participant Flow|NanoPac|"Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.~NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation."
10804056|NCT04221828|OG000|Outcome|NanoPac|"Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.~NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation."
10804057|NCT04221828|EG000|Reported Event|NanoPac|"Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.~NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation."
10820433|NCT00057876|EG000|Reported Event|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
10820434|NCT00057876|EG001|Reported Event|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
10820435|NCT00057941|BG000|Baseline|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
10820436|NCT00057941|BG001|Baseline|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
10820437|NCT00057941|BG002|Baseline|Total|Total of all reporting groups
10820438|NCT00057941|FG000|Participant Flow|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
10820439|NCT00057941|FG001|Participant Flow|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
11243366|NCT02502734|FG000|Participant Flow|Placebo Followed by Fluticasone Furoate|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
10820440|NCT00057941|OG000|Outcome|Anastrozole and ZD1839|
10820441|NCT00057941|OG001|Outcome|Fulvestrant and ZD1839|
10820442|NCT00057941|EG000|Reported Event|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
10820443|NCT00057941|EG001|Reported Event|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
10820444|NCT00057954|BG000|Baseline|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
10820445|NCT00057954|FG000|Participant Flow|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
10820446|NCT00057954|OG000|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
10820447|NCT00057954|EG000|Reported Event|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
10820448|NCT00058019|BG000|Baseline|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
10820449|NCT00058019|BG001|Baseline|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
10820450|NCT00058019|BG002|Baseline|Total|Total of all reporting groups
10820451|NCT00058019|FG000|Participant Flow|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
11202417|NCT02207413|BG004|Baseline|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202418|NCT02207413|BG005|Baseline|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202419|NCT02207413|BG006|Baseline|Total|Total of all reporting groups
11202420|NCT02207413|FG000|Participant Flow|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202421|NCT02207413|FG001|Participant Flow|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11215315|NCT02298322|OG000|Outcome|CoolSculpting Treatment|As-treated population of subjects who received CoolSculpting for subcutaneous fat reduction of the submental area who completed a Subject Satisfaction Questionnaire at the 12-week final follow-up visit.
10966723|NCT00888628|FG000|Participant Flow|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
10966724|NCT00888628|OG000|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
10966725|NCT00888628|EG000|Reported Event|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
10966726|NCT00888654|BG000|Baseline|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
10966727|NCT00888654|FG000|Participant Flow|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
10966728|NCT00888654|OG000|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
10966729|NCT00888654|EG000|Reported Event|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
10966730|NCT00888849|BG000|Baseline|Stapling|
10966731|NCT00888849|BG001|Baseline|Suturing|4 layered hand-sutured anastomosis
10966732|NCT00888849|BG002|Baseline|Total|Total of all reporting groups
10966733|NCT00888849|FG000|Participant Flow|Stapling|
10966734|NCT00888849|FG001|Participant Flow|Suturing|4 layered hand-sutured anastomosis
10966735|NCT00888849|OG000|Outcome|Suturing|Hand-sutured anastomosis
10966736|NCT00888849|OG001|Outcome|Stapling|Stapled Anastomosis
10966737|NCT00888849|EG000|Reported Event|Stapling|
10966738|NCT00888849|EG001|Reported Event|Suturing|4 layered hand-sutured anastomosis
10966739|NCT00888927|BG000|Baseline|Phase 1 Cohort 1|"First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966740|NCT00888927|BG001|Baseline|Phase 1 Cohort 2|"First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966741|NCT00888927|BG002|Baseline|Phase 1 Cohort 3|"First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966742|NCT00888927|BG003|Baseline|Phase 2|"First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week~If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966743|NCT00888927|BG004|Baseline|Total|Total of all reporting groups
10966744|NCT00888927|FG000|Participant Flow|Phase 1 Cohort 1|"First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
11215316|NCT02298322|EG000|Reported Event|CoolSculpting Treatment|Subjects treated with Coolsculpting for subcutaneous fat reduction in the submental area
10966745|NCT00888927|FG001|Participant Flow|Phase 1 Cohort 2|"First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966746|NCT00888927|FG002|Participant Flow|Phase 1 Cohort 3|"First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966747|NCT00888927|FG003|Participant Flow|Phase 2|"First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week~If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966748|NCT00888927|OG000|Outcome|Phase 1 Cohort 1|"First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966749|NCT00888927|OG001|Outcome|Phase 1 Cohort 2|"First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966750|NCT00888927|OG002|Outcome|Phase 1 Cohort 3|"First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966751|NCT00888927|OG003|Outcome|Phase 2|"First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week~If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966752|NCT00888927|EG000|Reported Event|Phase 1 Cohort 1|"First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966753|NCT00888927|EG001|Reported Event|Phase 1 Cohort 2|"First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966754|NCT00888927|EG002|Reported Event|Phase 1 Cohort 3|"First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week~KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966755|NCT00888927|EG003|Reported Event|Phase 2|"First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week~If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met."
10966756|NCT00888940|BG000|Baseline|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
10966757|NCT00888940|BG001|Baseline|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
10966758|NCT00888940|BG002|Baseline|Total|Total of all reporting groups
10966759|NCT00888940|FG000|Participant Flow|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
10966760|NCT00888940|FG001|Participant Flow|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
10966761|NCT00888940|OG000|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
10966762|NCT00888940|OG001|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
10966763|NCT00888940|EG000|Reported Event|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
10966764|NCT00888940|EG001|Reported Event|Cyklokapron|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
10966765|NCT00888979|BG000|Baseline|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
10966766|NCT00888979|FG000|Participant Flow|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
10966767|NCT00888979|OG000|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
10966768|NCT00888979|EG000|Reported Event|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
10966769|NCT00889005|BG000|Baseline|Cognitive Behavioral Therapy|"Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.~Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment"
10966770|NCT00889005|BG001|Baseline|Waitlist Control Group|Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
10966771|NCT00889005|BG002|Baseline|Total|Total of all reporting groups
10966772|NCT00889005|FG000|Participant Flow|Cognitive Behavioral Therapy|"Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.~Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment"
10966773|NCT00889005|FG001|Participant Flow|Waitlist Control Group|Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
10966774|NCT00889005|OG000|Outcome|Cognitive Behavioral Therapy|"Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.~Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment"
10966775|NCT00889005|OG001|Outcome|Waitlist Control Group|Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
10966776|NCT00889005|EG000|Reported Event|Cognitive Behavioral Therapy|"Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.~Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment"
10966777|NCT00889005|EG001|Reported Event|Waitlist Control Group|Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
10966778|NCT00889187|BG000|Baseline|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~All Phase I participants received the radiation regimen according to the established dose escalation schedule.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966779|NCT00889187|FG000|Participant Flow|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966780|NCT00889187|FG001|Participant Flow|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966781|NCT00889187|FG002|Participant Flow|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
11215317|NCT02298361|BG000|Baseline|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
10804058|NCT04095416|BG000|Baseline|Intervention|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Bilateral lower extremity compression wraps in addition to standard medical care~Compression wrap: Bilateral lower extremity compression wraps applied by trained research team"
10804059|NCT04095416|BG001|Baseline|Control|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Standard medical care"
10804060|NCT04095416|BG002|Baseline|Total|Total of all reporting groups
10804061|NCT04095416|FG000|Participant Flow|Intervention|"Bilateral lower extremity compression wraps in addition to standard medical care~Compression wrap: Bilateral lower extremity compression wraps applied by trained research team"
10804062|NCT04095416|FG001|Participant Flow|Control|Standard medical care
10804063|NCT04095416|OG000|Outcome|Intervention|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Bilateral lower extremity compression wraps in addition to standard medical care~Compression wrap: Bilateral lower extremity compression wraps applied by trained research team"
10804064|NCT04095416|OG001|Outcome|Control|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Standard medical care"
10804065|NCT04095416|EG000|Reported Event|Intervention|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Bilateral lower extremity compression wraps in addition to standard medical care~Compression wrap: Bilateral lower extremity compression wraps applied by trained research team"
10804066|NCT04095416|EG001|Reported Event|Control|"Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination.~Standard medical care"
10804067|NCT04532099|BG000|Baseline|LID018869, Then AOHP (Part A)|Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804068|NCT04532099|BG001|Baseline|AOHP, Then LID018869 (Part A)|Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804069|NCT04532099|BG002|Baseline|Biofinity (Part B)|Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804070|NCT04532099|BG003|Baseline|Total|Total of all reporting groups
10804071|NCT04532099|FG000|Participant Flow|LID018869, Then AOHP (Part A)|Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804072|NCT04532099|FG001|Participant Flow|AOHP, Then LID018869 (Part A)|Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804073|NCT04532099|FG002|Participant Flow|Biofinity (Part B)|Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804074|NCT04532099|OG000|Outcome|LID018869 (Part A)|Lehfilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804075|NCT04532099|OG001|Outcome|AOHP (Part A)|Senofilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
10804076|NCT04532099|EG000|Reported Event|Pretreatment Part A|Events reported in this group occurred prior to exposure to the study contact lenses.
11202422|NCT02207413|FG002|Participant Flow|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202423|NCT02207413|FG003|Participant Flow|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202424|NCT02207413|FG004|Participant Flow|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202425|NCT02207413|FG005|Participant Flow|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202426|NCT02207413|OG000|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202427|NCT02207413|OG001|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202428|NCT02207413|OG000|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202429|NCT02207413|OG001|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202430|NCT02207413|OG000|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202431|NCT02207413|OG001|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
10804077|NCT04532099|EG001|Reported Event|LID018869 Ocular (Part A)|Events reported in this group occurred while exposed to lehfilcon A contact lenses.
10804078|NCT04532099|EG002|Reported Event|LID018869 Nonocular|Events reported in this group occurred while exposed to lehfilcon A contact lenses.
11202432|NCT02207413|OG000|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202433|NCT02207413|OG001|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11215318|NCT02298361|BG001|Baseline|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
10804079|NCT04532099|EG003|Reported Event|AOHP Ocular|Events reported in this group occurred while exposed to senofilcon A contact lenses.
11202434|NCT02207413|OG000|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202435|NCT02207413|OG001|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202436|NCT02207413|OG000|Outcome|Influsplit Tetra_IP 6m-<5y Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
10804080|NCT04532099|EG004|Reported Event|AOHP Nonocular|Events reported in this group occurred while exposed to senofilcon A contact lenses.
11202437|NCT02207413|OG001|Outcome|Influsplit Tetra_LP 6m-<5y Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202438|NCT02207413|EG000|Reported Event|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202439|NCT02207413|EG001|Reported Event|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
11202440|NCT02207413|EG002|Reported Event|Influsplit Tetra_IP 3-17 y|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11202441|NCT02207413|EG003|Reported Event|Influsplit Tetra_LP 3-17 y|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
11215319|NCT02298361|BG002|Baseline|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
11215320|NCT02298361|BG003|Baseline|Total|Total of all reporting groups
11215321|NCT02298361|FG000|Participant Flow|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
11202442|NCT02207413|EG004|Reported Event|Influsplit Tetra_IP 6-35 m|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202443|NCT02207413|EG005|Reported Event|Influsplit Tetra_LP 6-35 m|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
11202444|NCT02207478|BG000|Baseline|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202445|NCT02207478|BG001|Baseline|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202446|NCT02207478|BG002|Baseline|Total|Total of all reporting groups
11202447|NCT02207478|FG000|Participant Flow|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.~ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202448|NCT02207478|FG001|Participant Flow|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202449|NCT02207478|OG000|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202450|NCT02207478|OG001|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202451|NCT02207478|EG000|Reported Event|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202452|NCT02207478|EG001|Reported Event|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
11202453|NCT02207491|BG000|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11202454|NCT02207491|BG001|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
10804081|NCT04532099|EG005|Reported Event|Pretreatment Part B|Events reported in this group occurred prior to exposure to the study contact lenses.
11202455|NCT02207491|BG002|Baseline|Total|Total of all reporting groups
11202456|NCT02207491|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11202457|NCT02207491|FG001|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202458|NCT02207491|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11202459|NCT02207491|OG001|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202460|NCT02207491|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11202461|NCT02207491|EG001|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202462|NCT02207530|BG000|Baseline|MEDI4736 10 mg/kg|MEDI4736 monotherapy: Durvalumab was provided at a dose of 10 mg/kg using an intravenous solution every 2 weeks until 12 months, disease progression, toxicity, or patient decision to stop therapy
11202463|NCT02207530|FG000|Participant Flow|MEDI4736 10 mg/kg|MEDI4736 monotherapy: Durvalumab was provided at a dose of 10 mg/kg using an intravenous solution every 2 weeks until 12 months, disease progression, toxicity, or patient decision to stop therapy
11202464|NCT02207530|OG000|Outcome|MEDI4736 10 mg/kg|MEDI4736 monotherapy: Durvalumab was provided at a dose of 10 mg/kg using an intravenous solution every 2 weeks until 12 months, disease progression, toxicity, or patient decision to stop therapy
11202465|NCT02207530|EG000|Reported Event|MEDI4736 10 mg/kg|MEDI4736 monotherapy: Durvalumab was provided at a dose of 10 mg/kg using an intravenous solution every 2 weeks until 12 months, disease progression, toxicity, or patient decision to stop therapy
11202466|NCT02207556|BG000|Baseline|Doxycycline (Localized Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202467|NCT02207556|BG001|Baseline|Doxycycline (Systemic Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202468|NCT02207556|BG002|Baseline|Total|Total of all reporting groups
11202469|NCT02207556|FG000|Participant Flow|Doxycycline (Localized Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202470|NCT02207556|FG001|Participant Flow|Doxacycline (Systemic Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202471|NCT02207556|OG000|Outcome|Doxycycline (Systemic Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202472|NCT02207556|OG000|Outcome|Doxycycline (6 Months)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202473|NCT02207556|OG001|Outcome|Doxycycline (1 Year)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202474|NCT02207556|OG000|Outcome|Doxycycline (Localized Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202475|NCT02207556|OG001|Outcome|Doxacycline (Systemic Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202476|NCT02207556|EG000|Reported Event|Doxycycline (Localized Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11202477|NCT02207556|EG001|Reported Event|Doxycycline (Systemic Disease)|"Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.~Doxycycline: Doxycycline will be continued until one of the following criteria is met:~Patient has completed 1 year of doxycycline therapy~Patient develops any grade 3-4 toxicity related to doxycycline use."
11215322|NCT02298361|FG001|Participant Flow|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
11243367|NCT02502734|FG001|Participant Flow|Fluticasone Furoate Followed by Placebo|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
11243368|NCT02502734|OG000|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
11243369|NCT02502734|OG001|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
11243370|NCT02502734|OG000|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
10804082|NCT04532099|EG006|Reported Event|Biofinity Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses.
11215323|NCT02298361|FG002|Participant Flow|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
10804083|NCT04532099|EG007|Reported Event|Biofinity Nonocular|Events reported in this group occurred while exposed to comfilcon A contact lenses.
11215324|NCT02298361|OG000|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
11215325|NCT02298361|OG001|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
11215326|NCT02298361|OG002|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
11215327|NCT02298361|EG000|Reported Event|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
11243371|NCT02502734|OG001|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
11243372|NCT02502734|EG000|Reported Event|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
11202478|NCT02207569|BG000|Baseline|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:>~Evolut R Transcatheter Aortic Valve (TAV)>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath>~EnVeo R Loading System (LS)> > CoreValve Evolut R TAVR system"
11202479|NCT02207569|FG000|Participant Flow|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
11202480|NCT02207569|OG000|Outcome|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV)~>~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath~>~EnVeo R Loading System (LS)~>~> CoreValve Evolut R TAVR system"
11202481|NCT02207569|EG000|Reported Event|CoreValve Evolut R TAVR System|"The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:~Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)"
11202482|NCT02207608|BG000|Baseline|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
11202483|NCT02207608|BG001|Baseline|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
11202484|NCT02207608|BG002|Baseline|Total|Total of all reporting groups
11202485|NCT02207608|FG000|Participant Flow|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
11202486|NCT02207608|FG001|Participant Flow|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
11202487|NCT02207608|OG000|Outcome|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
11202488|NCT02207608|OG001|Outcome|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
11202489|NCT02207608|EG000|Reported Event|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
11202490|NCT02207608|EG001|Reported Event|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
11202491|NCT02207621|BG000|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
11202492|NCT02207621|BG001|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202493|NCT02207621|BG002|Baseline|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202494|NCT02207621|BG003|Baseline|Total|Total of all reporting groups
11202495|NCT02207621|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
11202496|NCT02207621|FG001|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202497|NCT02207621|FG002|Participant Flow|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11202498|NCT02207621|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM & 1 drop placebo in the AM, OU
11202499|NCT02207621|OG001|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate BID in the AM and PM, OU
11202500|NCT02207621|OG002|Outcome|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 BID in the AM and PM, OU
11202501|NCT02207621|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM and 1 drop placebo in the AM in both eyes
11202502|NCT02207621|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the PM and 1 drop placebo in the AM, OU
11202503|NCT02207621|EG001|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate BID in the AM and PM, OU
11202504|NCT02207621|EG002|Reported Event|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 BID in the AM and PM, OU
11202505|NCT02207634|BG000|Baseline|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202506|NCT02207634|BG001|Baseline|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202507|NCT02207634|BG002|Baseline|Total|Total of all reporting groups
11202508|NCT02207634|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202509|NCT02207634|FG001|Participant Flow|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202510|NCT02207634|OG000|Outcome|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202511|NCT02207634|OG001|Outcome|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202512|NCT02207634|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
11202513|NCT02207634|EG001|Reported Event|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
11243373|NCT02502734|EG001|Reported Event|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
11202514|NCT02207725|BG000|Baseline|Placebo (Part I)|Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202515|NCT02207725|BG001|Baseline|Andexanet (Part I)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202516|NCT02207725|BG002|Baseline|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202517|NCT02207725|BG003|Baseline|Andexanet (Part II)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202518|NCT02207725|BG004|Baseline|Total|Total of all reporting groups
11202519|NCT02207725|FG000|Participant Flow|Placebo (Part I)|Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202520|NCT02207725|FG001|Participant Flow|Andexanet (Part I)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202521|NCT02207725|FG002|Participant Flow|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202522|NCT02207725|FG003|Participant Flow|Andexanet (Part II)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202523|NCT02207725|OG000|Outcome|Placebo (Part I)|Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202524|NCT02207725|OG001|Outcome|Andexanet (Part I)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202525|NCT02207725|OG002|Outcome|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
10804084|NCT04385199|BG000|Baseline|Convalescent Plasma Intervention|"Convalescent plasma 200mL transfusion~Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours"
11202526|NCT02207725|OG003|Outcome|Andexanet (Part II)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202527|NCT02207725|OG000|Outcome|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
11202528|NCT02207725|OG001|Outcome|Andexanet (Part II)|Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
11202529|NCT02207725|EG000|Reported Event|Placebo (Part I)|Vehicle Control
11202530|NCT02207725|EG001|Reported Event|Andexanet (Part I)|400 mg bolus
11202531|NCT02207725|EG002|Reported Event|Placebo (Part II)|Vehicle Control
11202532|NCT02207725|EG003|Reported Event|Andexanet (Part II)|400 mg bolus + 480 mg infusion (4 mg/min)
11202533|NCT02207803|BG000|Baseline|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
11202534|NCT02207803|BG001|Baseline|Control|Group receiving the standard of care at the rehabilitation facility
11202535|NCT02207803|BG002|Baseline|Total|Total of all reporting groups
11202536|NCT02207803|FG000|Participant Flow|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
11202537|NCT02207803|FG001|Participant Flow|Control|Group receiving the standard of care at the rehabilitation facility
11202538|NCT02207803|OG000|Outcome|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
11202539|NCT02207803|OG001|Outcome|Control|Group receiving the standard of care at the rehabilitation facility
11202540|NCT02207803|EG000|Reported Event|Transition Assistance Program|Group receiving the 5-session behavioral treatment from a clinician
11202541|NCT02207803|EG001|Reported Event|Control|Group receiving the standard of care at the rehabilitation facility
11202542|NCT02207816|BG000|Baseline|GSK257049 Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202543|NCT02207816|BG001|Baseline|GSK257049 Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202544|NCT02207816|BG002|Baseline|VeroRab/Menjugate Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202545|NCT02207816|BG003|Baseline|Total|Total of all reporting groups
11202546|NCT02207816|FG000|Participant Flow|GSK257049 Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202547|NCT02207816|FG001|Participant Flow|GSK257049 Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202548|NCT02207816|FG002|Participant Flow|VeroRab/Menjugate Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11215328|NCT02298361|EG001|Reported Event|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
11202549|NCT02207816|OG000|Outcome|GSK257049 [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.
11202550|NCT02207816|OG001|Outcome|GSK257049 Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.
11202551|NCT02207816|OG002|Outcome|VeroRab Comparator [5-17M] Group|Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.
11202552|NCT02207816|OG003|Outcome|GSK257049 [6-12W] Group|Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.
10970609|NCT00911170|BG001|Baseline|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11215329|NCT02298361|EG002|Reported Event|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
11215330|NCT02298491|BG000|Baseline|H.P. Acthar Gel|H.P. Acthar Gel: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
11202553|NCT02207816|OG004|Outcome|GSK257049 Comparator [6-12W] Group|Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.
11202554|NCT02207816|OG005|Outcome|Menjugate Comparator [6-12W] Group|Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.
11202555|NCT02207816|EG000|Reported Event|GSK257049 Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202556|NCT02207816|EG001|Reported Event|GSK257049 Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202557|NCT02207816|EG002|Reported Event|VeroRab/Menjugate Comparator Group|Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
11202558|NCT02207829|BG000|Baseline|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11202559|NCT02207829|BG001|Baseline|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
11202560|NCT02207829|BG002|Baseline|Total|Total of all reporting groups
11202561|NCT02207829|FG000|Participant Flow|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11202562|NCT02207829|FG001|Participant Flow|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
11202563|NCT02207829|OG000|Outcome|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11202564|NCT02207829|OG001|Outcome|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
10804085|NCT04385199|BG001|Baseline|Standard Therapy Control|Standard therapy for COVID-19 disease as defined by institutional protocols
10804086|NCT04385199|BG002|Baseline|Total|Total of all reporting groups
10970610|NCT00911170|BG002|Baseline|Total|Total of all reporting groups
11215331|NCT02298491|FG000|Participant Flow|H.P. Acthar Gel|H.P. Acthar Gel: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
11215332|NCT02298491|OG000|Outcome|H.P. Acthar Gel|H.P. Acthar Gel: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
11202565|NCT02207829|EG000|Reported Event|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11202566|NCT02207829|EG001|Reported Event|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
11202567|NCT02207907|BG000|Baseline|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202568|NCT02207907|BG001|Baseline|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202569|NCT02207907|BG002|Baseline|Total|Total of all reporting groups
11202570|NCT02207907|FG000|Participant Flow|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202571|NCT02207907|FG001|Participant Flow|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202572|NCT02207907|OG000|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202573|NCT02207907|OG001|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202574|NCT02207907|OG001|Outcome|0% Sodium Bicarbonate|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202575|NCT02207907|EG000|Reported Event|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
11202576|NCT02207907|EG001|Reported Event|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
11202577|NCT02207946|BG000|Baseline|IncobotulinumtoxinA 30 to 200 U|Participants received incobotulinumtoxinA (also known as NT 201) between 30 to 200 U, powder for solution for injection, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA.
11202578|NCT02207946|BG001|Baseline|Placebo|Participants received placebo solution matched to the volume of incobotulinumtoxinA solution, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA placebo.
11202579|NCT02207946|BG002|Baseline|Total|Total of all reporting groups
11202580|NCT02207946|FG000|Participant Flow|IncobotulinumtoxinA 30 to 200 Units|Participants received incobotulinumtoxinA (also known as NT 201) between 30 to 200 units (U), powder for solution for injection, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA.
11202581|NCT02207946|FG001|Participant Flow|Placebo|Participants received placebo solution matched to the volume of incobotulinumtoxinA solution, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA placebo.
11202582|NCT02207946|OG000|Outcome|IncobotulinumtoxinA 30 to 200 U|Participants received incobotulinumtoxinA (also known as NT 201) between 30 to 200 units (U), powder for solution for injection, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA.
11202583|NCT02207946|OG001|Outcome|Placebo|Participants received placebo solution matched to the volume of incobotulinumtoxinA solution, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA placebo.
11202584|NCT02207946|OG000|Outcome|IncobotulinumtoxinA 30 to 200 U|Participants received incobotulinumtoxinA (also known as NT 201) between 30 to 200 U, powder for solution for injection, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA.
11202585|NCT02207946|EG000|Reported Event|IncobotulinumtoxinA 30 to 200 U|Participants received incobotulinumtoxinA (also known as NT 201) between 30 to 200 U, powder for solution for injection, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA.
11202586|NCT02207946|EG001|Reported Event|Placebo|Participants received placebo solution matched to the volume of incobotulinumtoxinA solution, intramuscular injection, unilaterally into the muscles of the wrist, and optionally, into the elbow and shoulder as based upon kinematic analysis, in a single injection session on Day 1 (Visit 2). The maximum dose per injection site (more than one site per muscle were possible) was 25 U incobotulinumtoxinA placebo.
11215333|NCT02298491|EG000|Reported Event|H.P. Acthar Gel|H.P. Acthar Gel: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
11215334|NCT02298803|BG000|Baseline|Hypoglycemic Group|N=9; these participants experienced at least one episode of hypoglycaemia (blood glucose level <3.5mmol/L) during the monitoring period.
11215335|NCT02298803|BG001|Baseline|Normoglycemic Group|N=21; these participants experienced no episodes of hypoglycaemia during the monitoring period.
11243374|NCT02502864|BG000|Baseline|Standard of Care + Surveys|Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
11243375|NCT02502864|FG000|Participant Flow|Standard of Care + Surveys|"Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.~Standard of Care: Docetaxel: Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle."
11243376|NCT02502864|OG000|Outcome|Standard of Care + Surveys|Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
11243377|NCT02502864|EG000|Reported Event|Standard of Care + Surveys|Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
11243378|NCT02503085|BG000|Baseline|Overall Study|"Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.~Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions."
11215336|NCT02298803|BG002|Baseline|Total|Total of all reporting groups
11243379|NCT02503085|FG000|Participant Flow|Sequence 1-BACD: Nurofen for Children® - Algifor Dolo Junior®|"B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition."
11243380|NCT02503085|FG001|Participant Flow|Sequence 2-DCAB: Nurofen for Children® - Algifor Dolo Junior®|"D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition."
11243381|NCT02503085|FG002|Participant Flow|Sequence 3-CBDA: Nurofen for Children® - Algifor Dolo Junior®|"C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition."
11243382|NCT02503085|FG003|Participant Flow|Sequence 4-ADBC: Nurofen for Children® - Algifor Dolo Junior®|"A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.~D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.~B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.~C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition."
11243383|NCT02503085|OG000|Outcome|Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
11243384|NCT02503085|OG001|Outcome|Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)|Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
11243385|NCT02503085|OG002|Outcome|Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
11243386|NCT02503085|OG003|Outcome|Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)|Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
11243387|NCT02503085|EG000|Reported Event|Overall Study|"Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.~Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions."
11243388|NCT02503202|BG000|Baseline|V920 Consistency Lot A|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
11243389|NCT02503202|BG001|Baseline|V920 Consistency Lot B|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
11243390|NCT02503202|BG002|Baseline|V920 Consistency Lot C|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
11243391|NCT02503202|BG003|Baseline|V920 High-dose Lot|Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
11243392|NCT02503202|BG004|Baseline|Placebo|Participants received a 1.0-mL intramuscular injection of placebo on Day 1
11243393|NCT02503202|BG005|Baseline|Total|Total of all reporting groups
11243394|NCT02503202|FG000|Participant Flow|V920 Consistency Lot A|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
11243395|NCT02503202|FG001|Participant Flow|V920 Consistency Lot B|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
11243396|NCT02503202|FG002|Participant Flow|V920 Consistency Lot C|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
11243397|NCT02503202|FG003|Participant Flow|V920 High-dose Lot|Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
11243398|NCT02503202|FG004|Participant Flow|Placebo|Participants received a 1.0-mL intramuscular injection of placebo on Day 1
11243399|NCT02503202|OG000|Outcome|V920 Consistency Lot A|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
11243400|NCT02503202|OG001|Outcome|V920 Consistency Lot B|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
11243401|NCT02503202|OG002|Outcome|V920 Consistency Lot C|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
11243402|NCT02503202|OG003|Outcome|V920 High-dose Lot|Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
11243403|NCT02503202|OG004|Outcome|Placebo|Participants received a 1.0-mL intramuscular injection of placebo on Day 1
11243404|NCT02503202|EG000|Reported Event|V920 Consistency Lot A|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
11243405|NCT02503202|EG001|Reported Event|V920 Consistency Lot B|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
11243406|NCT02503202|EG002|Reported Event|V920 Consistency Lot C|Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
11243407|NCT02503202|EG003|Reported Event|V920 High-dose Lot|Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
11243408|NCT02503202|EG004|Reported Event|Placebo|Participants received a 1.0-mL intramuscular injection of placebo on Day 1
11243409|NCT02503215|BG000|Baseline|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
11243410|NCT02503215|FG000|Participant Flow|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
11243411|NCT02503215|OG000|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
11243412|NCT02503215|EG000|Reported Event|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
11243413|NCT02503254|BG000|Baseline|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
11243414|NCT02503254|BG001|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11243415|NCT02503254|BG002|Baseline|Total|Total of all reporting groups
10804087|NCT04385199|FG000|Participant Flow|Convalescent Plasma Intervention|"Convalescent plasma 200mL transfusion~Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours"
10804088|NCT04385199|FG001|Participant Flow|Standard Therapy Control|Standard therapy for COVID-19 disease as defined by institutional protocols
10804089|NCT04385199|OG000|Outcome|Convalescent Plasma Intervention|"Convalescent plasma 200mL transfusion~Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours"
11243416|NCT02503254|FG000|Participant Flow|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
11243417|NCT02503254|FG001|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11243418|NCT02503254|OG000|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
11243419|NCT02503254|OG001|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11243420|NCT02503254|EG000|Reported Event|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
11243421|NCT02503254|EG001|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
11243422|NCT02503254|EG002|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.0 at Admission (Day -3) but were not randomized
11243423|NCT02503332|BG000|Baseline|Pegcetacoplan Monthly|Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.
11243424|NCT02503332|BG001|Baseline|Pegcetacoplan EOM|Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243425|NCT02503332|BG002|Baseline|Sham Pooled|"Sham Monthly: Subjects received sham injections once monthly for 12 months.~Sham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred."
11243426|NCT02503332|BG003|Baseline|Total|Total of all reporting groups
11243427|NCT02503332|FG000|Participant Flow|Pegcetacoplan Monthly|Subjects received intravitreal (IVT) injections of pegcetacoplan 15 milligrams (mg)/100 microliters (μL) once monthly for 12 months.
11243428|NCT02503332|FG001|Participant Flow|Pegcetacoplan EOM|Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243429|NCT02503332|FG002|Participant Flow|Sham Monthly|Subjects received sham injections once monthly for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
11243430|NCT02503332|FG003|Participant Flow|Sham EOM|Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
11243431|NCT02503332|OG000|Outcome|Pegcetacoplan Monthly|Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.
11243432|NCT02503332|OG001|Outcome|Pegcetacoplan EOM|Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243433|NCT02503332|OG002|Outcome|Sham Pooled|"Sham Monthly: Subjects received sham injections once monthly for 12 months.~Sham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred."
11243434|NCT02503332|EG000|Reported Event|Pegcetacoplan Monthly: Ocular Study Eye|Ocular TEAEs are summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.
11243435|NCT02503332|EG001|Reported Event|Pegcetacoplan EOM: Ocular Study Eye|Ocular TEAEs are summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243436|NCT02503332|EG002|Reported Event|Sham Pooled: Ocular Study Eye|"Ocular TEAEs are summarized for the study eye for all subjects who randomized to sham monthly and sham EOM treatment groups.~Sham Monthly: Subjects received sham injections once monthly for 12 months.~Sham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred."
11243437|NCT02503332|EG003|Reported Event|Pegcetacoplan Monthly: Ocular Fellow Eye|Ocular TEAEs are summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.
11243438|NCT02503332|EG004|Reported Event|Pegcetacoplan EOM: Ocular Fellow Eye|Ocular TEAEs are summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243439|NCT02503332|EG005|Reported Event|Sham Pooled: Ocular Fellow Eye|"Ocular TEAEs are summarized for the fellow eye for all subjects who randomized to sham monthly and sham EOM treatment groups.~Sham Monthly: Subjects received sham injections once monthly for 12 months.~Sham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred."
11243440|NCT02503332|EG006|Reported Event|Pegcetacoplan Monthly: Non-ocular|Non-ocular (systemic) TEAEs are summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.
10804090|NCT04385199|OG001|Outcome|Standard Therapy Control|Standard therapy for COVID-19 disease as defined by institutional protocols
10804091|NCT04385199|EG000|Reported Event|Intervention|"Convalescent plasma 200mL transfusion~Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours"
10804092|NCT04385199|EG001|Reported Event|Control|Standard therapy for COVID-19 disease as defined by institutional protocols
10804093|NCT04382053|BG000|Baseline|DFV890 + SoC|DFV890 was administered for 14 days in addition to SoC.
10804094|NCT04382053|BG001|Baseline|Standard of Care (SoC)|SoC was used as an active comparator arm.
10804095|NCT04382053|BG002|Baseline|Total|Total of all reporting groups
10804096|NCT04382053|FG000|Participant Flow|DFV890 + SoC|DFV890 was administered for 14 days in addition to SoC.
10804097|NCT04382053|FG001|Participant Flow|Standard of Care (SoC)|SoC was used as an active comparator arm.
10804098|NCT04382053|OG000|Outcome|DFV890 + SoC|DFV890 was administered for 14 days in addition to SoC.
11243441|NCT02503332|EG007|Reported Event|Pegcetacoplan EOM: Non-ocular|Non-ocular (systemic) TEAEs are summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.
11243442|NCT02503332|EG008|Reported Event|Sham Pooled: Non-ocular|"Non-ocular (systemic) TEAEs are summarized for all subjects who randomized to sham monthly and sham EOM treatment groups.~Sham Monthly: Subjects received sham injections once monthly for 12 months.~Sham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred."
10804099|NCT04382053|OG001|Outcome|Standard of Care (SoC)|SoC was used as an active comparator arm.
11243443|NCT02503410|BG000|Baseline|Usual Care|Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
10966782|NCT00889187|FG003|Participant Flow|Phase II: Photon Rad (MTD)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
11243444|NCT02503410|BG001|Baseline|Interactive Gaming|Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
11243445|NCT02503410|BG002|Baseline|Total|Total of all reporting groups
11243446|NCT02503410|FG000|Participant Flow|Usual Care|Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
11243447|NCT02503410|FG001|Participant Flow|Interactive Gaming|Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
10804100|NCT04382053|EG000|Reported Event|DFV890 + SoC|DFV890 was administered for 14 days in addition to SoC.
11286123|NCT02883452|EG001|Reported Event|Cohort 2: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
11202587|NCT02207972|BG000|Baseline|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia."
11202588|NCT02207972|BG001|Baseline|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
11202589|NCT02207972|BG002|Baseline|Total|Total of all reporting groups
11202590|NCT02207972|FG000|Participant Flow|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia."
11202591|NCT02207972|FG001|Participant Flow|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
11202592|NCT02207972|OG000|Outcome|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes"
10804101|NCT04382053|EG001|Reported Event|Standard of Care (SoC)|SoC was used as an active comparator arm.
11202593|NCT02207972|OG001|Outcome|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
11202594|NCT02207972|OG000|Outcome|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes."
10804102|NCT04382053|EG002|Reported Event|Total|Total
11202595|NCT02207972|EG000|Reported Event|Use of Ultrasound|"Woman requests epidural for pain relief Ultrasound guided CSE placed~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~Use of Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes."
11202596|NCT02207972|EG001|Reported Event|No Ultrasound Used|"Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks~Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml~No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia"
11202597|NCT02208037|BG000|Baseline|Tacrolimus/Methotrexate/Bortezomib|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Bortezomib.
11202598|NCT02208037|BG001|Baseline|Tacrolimus/Methotrexate/Maraviroc|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Maraviroc.
11202599|NCT02208037|BG002|Baseline|Tacrolimus/MMF/Cyclophosphamide|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Mycophenolate Mofetil (MMF), and Cyclophosphamide.
11202600|NCT02208037|BG003|Baseline|Total|Total of all reporting groups
11243448|NCT02503410|OG000|Outcome|Usual Care Group|"physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week)~Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks."
11286124|NCT02883452|EG002|Reported Event|Cohort 3: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
11202601|NCT02208037|FG000|Participant Flow|Tacrolimus/Methotrexate/Bortezomib|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Bortezomib.
11202602|NCT02208037|FG001|Participant Flow|Tacrolimus/Methotrexate/Maraviroc|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Maraviroc.
11202603|NCT02208037|FG002|Participant Flow|Tacrolimus/MMF/Cyclophosphamide|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Mycophenolate Mofetil (MMF), and Cyclophosphamide.
11202604|NCT02208037|OG000|Outcome|Tacrolimus/Methotrexate/Bortezomib|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Bortezomib.
11202605|NCT02208037|OG001|Outcome|Tacrolimus/Methotrexate/Maraviroc|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Maraviroc.
11202606|NCT02208037|OG002|Outcome|Tacrolimus/MMF/Cyclophosphamide|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Mycophenolate Mofetil (MMF), and Cyclophosphamide.
11202607|NCT02208037|EG000|Reported Event|Tacrolimus/Methotrexate/Bortezomib|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Bortezomib.
11202608|NCT02208037|EG001|Reported Event|Tacrolimus/Methotrexate/Maraviroc|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Methotrexate, and Maraviroc.
11202609|NCT02208037|EG002|Reported Event|Tacrolimus/MMF/Cyclophosphamide|Participants will receive a GVHD prophylactic regimen of three agents: Tacrolimus, Mycophenolate Mofetil (MMF), and Cyclophosphamide.
11202610|NCT02208050|BG000|Baseline|Group 1: Fampridine Followed by Placebo|"Patients will be randomised to a 8 week treatment period with the active drug followed by a 2 week washout period before an 8 week treatment period with placebo.~Fampridine~Placebo"
11202611|NCT02208050|BG001|Baseline|Group 2: Placebo Followed by Fampridine|"Patients will be randomised to a 8 week treatment period with the placebo, followed by a 2 week washout period and a further 8 week treatment period with the active drug.~Fampridine~Placebo"
11202612|NCT02208050|BG002|Baseline|Total|Total of all reporting groups
11202613|NCT02208050|FG000|Participant Flow|Group A: Fampridine Followed by Placebo|Participants who received fampridine first before crossing over to the placebo arm. Following baseline assessment and randomisation, participants received 10mg pr-fampridine twice daily for eight weeks followed by a two week washout period and then received placebo tablet twice daily for ten weeks.
11202614|NCT02208050|FG001|Participant Flow|Group B: Placebo Followed by Fampridine|Participants who received placebo first before crossing over to fampridine. After baseline assessment and randomisation, participants received placebo twice daily for 8 weeks, then had a 2 week washout period, followed by 8 weeks of treatment with 10mg pr-fampridine.
11202615|NCT02208050|OG000|Outcome|PR-Fampridine|10mg fampridine twice daily for 8 weeks.
11202616|NCT02208050|OG001|Outcome|Placebo|Placebo tablets twice daily for 8 weeks.
11202617|NCT02208050|OG000|Outcome|Fampridine|Fampridine 10mg bd treated participants in either Period 2 or Period 4.
11202618|NCT02208050|OG001|Outcome|Placebo|Placebo treated participants in Period 2 and Period 4.
11202619|NCT02208050|OG000|Outcome|Fampridine|Fampridine 10mg BD for eight weeks with baseline assessment and washout period.
11202620|NCT02208050|OG001|Outcome|Placebo|Placebo BD for eight weeks with baseline assessment and washout period.
11202621|NCT02208050|OG000|Outcome|Fampridine|Average scores for participants treated with fampridine during weeks 2-10 or weeks 12-20.
11202622|NCT02208050|OG001|Outcome|Placebo|Average scores for patients when treated with placebo during weeks 2-10 or weeks 12-20.
11202623|NCT02208050|OG000|Outcome|On Treatment: Fampridine|Assessments during on-treatment periods with fampridine.
11202624|NCT02208050|OG001|Outcome|Placebo|Assessments during on-treatment periods with Placebo.
11202625|NCT02208050|OG000|Outcome|Fampridine|Assessments while participants on treatment with fampridine (4&5 or 7&8).
11202626|NCT02208050|OG001|Outcome|Placebo|Assessments while on treatment with placebo (4&5 or 7&8)
11202627|NCT02208050|OG000|Outcome|Fampridine: MSIS-20|MSIS-20 scores during treatment with fampridine.
11202628|NCT02208050|OG001|Outcome|Placebo: MSIS20|MSIS-20 scores during treatment with placebo.
11202629|NCT02208050|OG002|Outcome|Fampridine: MSIS-9|MSIS-9 scores during treatment with fampridine
11202630|NCT02208050|OG003|Outcome|Placebo: MSIS-9|MSIS-9 scores during treatment with placebo.
11202631|NCT02208050|EG000|Reported Event|Fampridine|Adverse events reported by the patients when treated with Fampridine
11202632|NCT02208050|EG001|Reported Event|Placebo|Adverse events reported by the patients when treated with placebo.
11202633|NCT02208063|BG000|Baseline|Telavancin|"7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes~Telavancin"
11202634|NCT02208063|BG001|Baseline|Standard of Care|"Vancomycin, Daptomycin, synthetic penicillin or Cefazolin~Vancomycin~Daptomycin~Synthetic penicillin~Cefazolin"
11202635|NCT02208063|BG002|Baseline|Total|Total of all reporting groups
11202636|NCT02208063|FG000|Participant Flow|Telavancin|"7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes~Telavancin"
11202637|NCT02208063|FG001|Participant Flow|Standard of Care|"Vancomycin, Daptomycin, synthetic penicillin or Cefazolin~Vancomycin~Daptomycin~Synthetic penicillin~Cefazolin"
11202638|NCT02208063|OG000|Outcome|Telavancin|"7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes~Telavancin"
11202639|NCT02208063|OG001|Outcome|Standard of Care|"Vancomycin, Daptomycin, synthetic penicillin or Cefazolin~Vancomycin~Daptomycin~Synthetic penicillin~Cefazolin"
11202640|NCT02208063|EG000|Reported Event|Telavancin|"7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes~Telavancin"
11202641|NCT02208063|EG001|Reported Event|Standard of Care|"Vancomycin, Daptomycin, synthetic penicillin or Cefazolin~Vancomycin~Daptomycin~Synthetic penicillin~Cefazolin"
11243449|NCT02503410|OG001|Outcome|Interactive Home-Based System Group|"physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week)~Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period.~Valedo® System (Hocoma AG)"
11202642|NCT02208089|BG000|Baseline|TransPRKCXL|"Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)~Transepithelial Photorefractive Keratectomy (TransPRK): Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).~Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
11202643|NCT02208089|BG001|Baseline|CXL Only|"Corneal collagen cross-linking (CXL), manual corneal epithelial removal, no excimer laser treatment~CXL protocol was identical in both study arms. After corneal epithelial removal, a 10 minute soak with Vibex rapid (www.avedro.com) was followed by 8 minutes pulsed UV light using a uniform beam source (KXL - www.avedro.com) and a 1.5 second on/off cycle (7.2mJ/cm2 total energy @ 30mW/cm2 irradiance)."
11202644|NCT02208089|BG002|Baseline|Total|Total of all reporting groups
11202645|NCT02208089|FG000|Participant Flow|TransPRKCXL|"Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)~Transepithelial Photorefractive Keratectomy (TransPRK): Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).~Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
11202646|NCT02208089|FG001|Participant Flow|CXL Only|Patients treated with standard accelerated corneal collagen cross-linking (historical controls)
11202647|NCT02208089|OG000|Outcome|TransPRKCXL|"Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)~Transepithelial Photorefractive Keratectomy (TransPRK): Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).~Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
11202648|NCT02208089|OG001|Outcome|CXL Only|CXL only (no PRK) using manual corneal epithelial removal and the same accelerated pulsed protocol as used in the TransPRK group
11202649|NCT02208089|OG001|Outcome|CXL Only|"Corneal collagen cross-linking (CXL), manual corneal epithelial removal, no excimer laser treatment~CXL protocol was identical in both study arms. After corneal epithelial removal, a 10 minute soak with Vibex rapid (www.avedro.com) was followed by 8 minutes pulsed UV light using a uniform beam source (KXL - www.avedro.com) and a 1.5 second on/off cycle (7.2mJ/cm2 total energy @ 30mW/cm2 irradiance)."
11202650|NCT02208089|EG000|Reported Event|TransPRKCXL|"Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)~Transepithelial Photorefractive Keratectomy (TransPRK): Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).~Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
11202651|NCT02208089|EG001|Reported Event|CXL Only|"Standard accelerated corneal collagen cross-linking (historical controls)~Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
11202652|NCT02208297|BG000|Baseline|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID)~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11202653|NCT02208297|BG001|Baseline|Vehicle Gel (BID)|"Vehicle gel administered two times daily (BID)~Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days"
11202654|NCT02208297|BG002|Baseline|Total|Total of all reporting groups
11202655|NCT02208297|FG000|Participant Flow|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID)~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11202656|NCT02208297|FG001|Participant Flow|Vehicle Gel (BID)|"Vehicle gel administered two times daily (BID)~Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days"
11202657|NCT02208297|OG000|Outcome|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID)~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11202658|NCT02208297|OG001|Outcome|Vehicle Gel (BID)|"Vehicle gel administered two times daily (BID)~Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days"
11202659|NCT02208297|EG000|Reported Event|Loteprednol Etabonate Gel (BID)|"Loteprednol Etabonate Gel 0.38% administered two times daily (BID)~Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days"
11202660|NCT02208297|EG001|Reported Event|Vehicle Gel (BID)|"Vehicle gel administered two times daily (BID)~Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days"
11243450|NCT02503410|OG000|Outcome|Usual Care|Subjects receive physical therapy for low back pain as typically prescribed in the clinic
11202661|NCT02208310|BG000|Baseline|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
11202662|NCT02208310|BG001|Baseline|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
11202663|NCT02208310|BG002|Baseline|Total|Total of all reporting groups
11202664|NCT02208310|FG000|Participant Flow|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
11202665|NCT02208310|FG001|Participant Flow|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
10966783|NCT00889187|OG000|Outcome|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~All Phase I participants received the radiation regimen according to the established dose escalation schedule.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
11202666|NCT02208310|OG000|Outcome|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
11202667|NCT02208310|OG001|Outcome|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
11202668|NCT02208310|EG000|Reported Event|Low Dose Vitamin D|"Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.~Cholecalciferol 400 IU"
11202669|NCT02208310|EG001|Reported Event|High Dose Vitamin D|"Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.~Cholecalciferol 10,000 IU"
11202670|NCT02208349|BG000|Baseline|Video Laryngoscopy Treatment|Patients treated by ambulance agency with video laryngoscopy.
11202671|NCT02208349|BG001|Baseline|Direct Laryngoscopy Treatment|Patients treated by ambulance agency with direct laryngoscopy.
11202672|NCT02208349|BG002|Baseline|Total|Total of all reporting groups
11202673|NCT02208349|FG000|Participant Flow|Video Laryngoscopy First Then Direct Laryngoscopy|"We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.~King Video Laryngoscope: We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods."
11202674|NCT02208349|FG001|Participant Flow|Direct Laryngoscopy First Then Video Laryngoscopy|"We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.~traditional direct laryngoscopy (DL)"
11202675|NCT02208349|OG000|Outcome|Video Laryngoscopy|Participants who were treated by an ambulance agency randomized to received VL
11202676|NCT02208349|OG001|Outcome|Direct Laryngoscopy|Participants who were treated by an ambulance agency randomized to receive DL
11202677|NCT02208349|OG000|Outcome|Video Laryngoscopy|Patients treated by an ambulance agency randomized to VL
11202678|NCT02208349|OG001|Outcome|Direct Laryngoscopy|Patients treated by an ambulance agency randomized to DL
11202679|NCT02208349|EG000|Reported Event|Video Laryngoscopy|Patients treated by an ambulance agency randomized to VL
11202680|NCT02208349|EG001|Reported Event|Direct Laryngoscopy|Patients treated by an ambulance agency randomized to DL
11202681|NCT02208466|BG000|Baseline|Active rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days."
11202682|NCT02208466|BG001|Baseline|Sham rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered."
11202683|NCT02208466|BG002|Baseline|Sham rTMS/Placebo Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.~Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days."
11202684|NCT02208466|BG003|Baseline|Total|Total of all reporting groups
11202685|NCT02208466|FG000|Participant Flow|Active rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days."
11202686|NCT02208466|FG001|Participant Flow|Sham rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered."
11243451|NCT02503410|OG001|Outcome|Interactive Gaming|Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
11243452|NCT02503410|OG000|Outcome|Usual Care|"Subjects receive physical therapy for low back pain as typically prescribed in the clinic.~Usual care: Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist."
11202687|NCT02208466|FG002|Participant Flow|Sham rTMS/Placebo Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.~Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days."
11202688|NCT02208466|OG000|Outcome|Active rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days."
11202689|NCT02208466|OG001|Outcome|Sham rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered."
11202690|NCT02208466|OG002|Outcome|Sham rTMS/Placebo Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.~Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days."
11202691|NCT02208466|EG000|Reported Event|Active rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days."
11202692|NCT02208466|EG001|Reported Event|Sham rTMS/Active Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.~Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered."
11202693|NCT02208466|EG002|Reported Event|Sham rTMS/Placebo Fluoxetine|"Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.~Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.~Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days."
11215337|NCT02298803|FG000|Participant Flow|Holter and Glucose Monitoring|"In this study all participants underwent simultaneous monitoring of glucose and QT interval via a subcutaneous continuous glucose monitor and a Hoter monitor, respectively.~Holter and Glucose monitoring: (i) Continuous Glucose Monitoring A sterile disposable glucose-sensing sensor was inserted into the subcutaneous tissue in the abdomen of the patient. This sensor automatically measured the average glucose concentration in interstitial fluid every 5 minutes. The monitor was worn for 48 hours.~(ii)Holter Monitoring The Holter monitor was worn for the same period as the continuous glucose monitor. QT intervals were extracted using proprietary software. Study participants were encouraged to perform regular daily activities during monitoring."
11215338|NCT02298803|OG000|Outcome|Hypoglycemia Group|While there were nine study participants who experienced hypoglycemia during the entire study period, only eight of those participants experienced hypoglycemia during the nocturnal time period (2300-0700). Six study participants experienced isolated nocturnal hypoglycemia; two study participants experienced both nocturnal and day time hypoglycemia. Hypoglycemia during monitoring was defined as a blood glucose level <3.5mmol/L that was sustained for a minimum of 20 consecutive minutes.
11215339|NCT02298803|OG000|Outcome|Hypoglycemia Group|While there were nine study participants who experienced hypoglycemia during the entire study period, only three of those participants experienced hypoglycemia during the day time period (0700-2300). One study participant experienced isolated day time hypoglycemia; two study participants experienced both nocturnal and day time hypoglycemia. Hypoglycemia during monitoring was defined as a blood glucose level <3.5mmol/L that was sustained for a minimum of 20 consecutive minutes.
11202694|NCT02208843|BG000|Baseline|Afatinib 40 mg|All patients received continuous daily treatment with Afatinib at a starting dose of 40 milligram (mg), treatment interruption and reduction scheme to 30 mg and then to 20 mg were permitted to manage treatment-related adverse events (AEs). Patients were orally administered with the film coated tablet once a day without food.
11202695|NCT02208843|FG000|Participant Flow|Afatinib 40 mg|All patients received continuous daily treatment with Afatinib at a starting dose of 40 milligram (mg), treatment interruption and reduction scheme to 30 mg and then to 20 mg were permitted to manage treatment-related adverse events (AEs). Patients were orally administered with the film coated tablet once a day without food.
11202696|NCT02208843|OG000|Outcome|Afatinib 40 mg|All patients received continuous daily treatment with Afatinib at a starting dose of 40 milligram (mg), treatment interruption and reduction scheme to 30 mg and then to 20 mg were permitted to manage treatment-related adverse events (AEs). Patients were orally administered with the film coated tablet once a day without food.
11202697|NCT02208843|EG000|Reported Event|Afatinib 40 mg|All patients received continuous daily treatment with Afatinib at a starting dose of 40 milligram (mg), treatment interruption and reduction scheme to 30 mg and then to 20 mg were permitted to manage treatment-related adverse events (AEs). Patients were orally administered with the film coated tablet once a day without food.
11202698|NCT02208999|BG000|Baseline|Implanted Patients|91 patients de novo implanted with the neurostimulator Precision.
11202699|NCT02208999|BG001|Baseline|Reimplanted Patients|15 patients had a replacement with the neurostimulator Precision.
11202700|NCT02208999|BG002|Baseline|Total|Total of all reporting groups
11202701|NCT02208999|FG000|Participant Flow|Patients Implanted or Reimplanted With Precision|All patients included must have been implanted with the neurostimulator Precision.107 patients were included. One of them was excluded because he was less than 18 years old. So 106 patients were analysed: 91 implanted patients (de novo implants) and 15 reimplanted patients (replacement implants)
11202702|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants)|Primary outcome measure was estimated only in implanted patients (de novo implants)
11202703|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Percentage of de novo patients with an improvement of at least 30% for pain at 12 months after inclusion
11202704|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
11202705|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|"Percentage of de novo patients for whom pain relief before the implantation was improved to very improved at 12 months"
11202706|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|"Percentage of de novo patients for whom pain relief felt before the implantation was improved to very improved at 24 months"
11202707|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Rate of primary implanted patients who took at least one analgesic treatment at 1 year
11202708|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|Rate of primary implanted patients who took at least one analgesic treatment at 24 months.
11202709|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Percentage of de novo patients with an increase of SF-12 at 12 months
11202710|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|Percentage of de novo patients with an increase of SF-12 at 12 months at 24 months
11202711|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Percentage of de novo patients willing to restart treatment at 12 months
11202712|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|Percentage of de novo patients willing to restart treatment at 24 months
11202713|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Percentage of de novo patients with anxiety and depression at 12 months
11202714|NCT02208999|OG001|Outcome|Percentage of de Novo Patients at 24 Months|Percentage of de novo patients with anxiety and depression at 24 months
11202715|NCT02208999|OG000|Outcome|Implanted Patients (de Novo Implants) at 12 Months|Posology of level 3 analgesics at 12 months in de novo implanted patients
11202716|NCT02208999|OG001|Outcome|Implanted Patients (de Novo Implants) at 24 Months|Posology of level 3 analgesics at 24 months in de novo implanted patients .
11202717|NCT02208999|EG000|Reported Event|Overall Population: Implanted and Reimplanted Patients|Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision
11202718|NCT02208999|EG001|Reported Event|Patients With an Event Related to the Device|Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision and for whom the AE (or SAE) was related to this device
11202719|NCT02209064|BG000|Baseline|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
11202720|NCT02209064|FG000|Participant Flow|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
11202721|NCT02209064|OG000|Outcome|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
11202722|NCT02209064|OG000|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
11202723|NCT02209064|EG000|Reported Event|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
11202724|NCT02209181|BG000|Baseline|Placebo|Three placebo capsules taken orally
11202725|NCT02209181|BG001|Baseline|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
11202726|NCT02209181|BG002|Baseline|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
11202727|NCT02209181|BG003|Baseline|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
11202728|NCT02209181|BG004|Baseline|Total|Total of all reporting groups
11202729|NCT02209181|FG000|Participant Flow|Placebo|Three placebo capsules taken orally
11202730|NCT02209181|FG001|Participant Flow|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
11202731|NCT02209181|FG002|Participant Flow|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
11202732|NCT02209181|FG003|Participant Flow|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
11202733|NCT02209181|OG000|Outcome|Placebo|Three placebo capsules taken orally
11202734|NCT02209181|OG001|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
11202735|NCT02209181|OG002|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
11202736|NCT02209181|OG003|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
11202737|NCT02209181|EG000|Reported Event|Placebo|Three placebo capsules taken orally
11202738|NCT02209181|EG001|Reported Event|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
11202739|NCT02209181|EG002|Reported Event|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
11202740|NCT02209181|EG003|Reported Event|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
11202741|NCT02209259|BG000|Baseline|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
11202742|NCT02209259|BG001|Baseline|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
11202743|NCT02209259|BG002|Baseline|Control|The third group (the control arm) will not complete the PCS.
11202744|NCT02209259|BG003|Baseline|Total|Total of all reporting groups
11202745|NCT02209259|FG000|Participant Flow|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
11202746|NCT02209259|FG001|Participant Flow|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
11202747|NCT02209259|FG002|Participant Flow|Control|The third group (the control arm) will not complete the PCS.
11202748|NCT02209259|OG000|Outcome|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
11202749|NCT02209259|OG001|Outcome|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
11202750|NCT02209259|OG002|Outcome|Control|The third group (the control arm) will not complete the PCS.
11202751|NCT02209259|EG000|Reported Event|Standard PCS|The first intervention group will be comprised of patients who will complete the standard PCS.
11202752|NCT02209259|EG001|Reported Event|Positively-adjusted PCS|The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
11202753|NCT02209259|EG002|Reported Event|Control|The third group (the control arm) will not complete the PCS.
11202754|NCT02209272|BG000|Baseline|Bacteriostatic Saline|"In this arm patients received 2 injections:~one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle~a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle~VAS-pain scores were collected immediately after each injection."
11202755|NCT02209272|BG001|Baseline|Buffered Lidocaine|"In this arm patients received 2 injections:~one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle~a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle~VAS-pain scores were collected immediately after each injection."
11202756|NCT02209272|BG002|Baseline|Total|Total of all reporting groups
11202757|NCT02209272|FG000|Participant Flow|Bacteriostatic Saline|"In this arm patients received 2 injections:~one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle~a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle~VAS-pain scores were collected immediately after each injection."
11202758|NCT02209272|FG001|Participant Flow|Buffered Lidocaine|"In this arm patients received 2 injections:~one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle~a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle~VAS-pain scores were collected immediately after each injection."
11202759|NCT02209272|OG000|Outcome|Bacteriostatic Saline|"for ultrasound guided hip joint injection local anesthesia~bacteriostatic saline"
11202760|NCT02209272|OG001|Outcome|Buffered Lidocaine|"for ultrasound guided hip joint injection local anesthesia~buffered lidocaine"
11202761|NCT02209272|EG000|Reported Event|Bacteriostatic Saline|"for ultrasound guided hip joint injection local anesthesia~bacteriostatic saline"
11202762|NCT02209272|EG001|Reported Event|Buffered Lidocaine|"for ultrasound guided hip joint injection local anesthesia~buffered lidocaine"
11202763|NCT02209454|BG000|Baseline|Entire Study Population|Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
11202764|NCT02209454|FG000|Participant Flow|Reference IMP First, Then Test IMP|25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
11243453|NCT02503410|OG001|Outcome|Interactive Gaming|"Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.~Interactive gaming: Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system."
11243454|NCT02503410|OG000|Outcome|Usual Care|Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
11243455|NCT02503410|EG000|Reported Event|Usual Care|Subjects receive physical therapy for low back pain as typically prescribed in the clinic
11243456|NCT02503410|EG001|Reported Event|Interactive Gaming|Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
11243457|NCT02503501|BG000|Baseline|Insulin Glulisine|"Insulin Glulisine 20 IU (0.1ml/10 units in each nostril) per intranasal dose, 2 times per day for 6 months~Insulin glulisine"
11243458|NCT02503501|BG001|Baseline|Placebo|"Saline 20 IU (0.1 ml in each nostril) per intranasal dose, 2 times per day for 6 months~Placebo: Bacteriostatic 0.9% Sodium Chloride"
11243459|NCT02503501|BG002|Baseline|Total|Total of all reporting groups
11243460|NCT02503501|FG000|Participant Flow|Insulin Glulisine|"Insulin Glulisine 20 IU (0.1ml/10 units in each nostril) per intranasal dose, 2 times per day for 6 months~Insulin glulisine"
11243461|NCT02503501|FG001|Participant Flow|Placebo|"Saline 20 IU (0.1 ml in each nostril) per intranasal dose, 2 times per day for 6 months~Placebo: Bacteriostatic 0.9% Sodium Chloride"
11243462|NCT02503501|OG000|Outcome|Insulin Glulisine|"Insulin Glulisine 20 IU (0.1ml/10 units in each nostril) per intranasal dose, 2 times per day for 6 months~Insulin glulisine"
11243463|NCT02503501|OG001|Outcome|Placebo|"Saline 20 IU (0.1 ml in each nostril) per intranasal dose, 2 times per day for 6 months~Placebo: Bacteriostatic 0.9% Sodium Chloride"
11243464|NCT02503501|EG000|Reported Event|Insulin Glulisine|"Insulin Glulisine 20 IU (0.1ml/10 units in each nostril) per intranasal dose, 2 times per day for 6 months~Insulin glulisine"
11243465|NCT02503501|EG001|Reported Event|Placebo|"Saline 20 IU (0.1 ml in each nostril) per intranasal dose, 2 times per day for 6 months~Placebo: Bacteriostatic 0.9% Sodium Chloride"
11243466|NCT02503540|BG000|Baseline|Aflibercept|"Monthly aflibercept for 6 months and then every other month for 6 months.~Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12."
11243467|NCT02503540|FG000|Participant Flow|Aflibercept|"Monthly aflibercept for 6 months and then every other month for 6 months.~Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12."
11243468|NCT02503540|OG000|Outcome|Aflibercept|"Monthly aflibercept for 6 months and then every other month for 6 months.~Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12."
11243469|NCT02503540|EG000|Reported Event|Aflibercept|"Monthly aflibercept for 6 months and then every other month for 6 months.~Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12."
11243470|NCT02503735|BG000|Baseline|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Sofosbuvir/Ledipasvir (400mg/90mg) FDC: 12 weeks treatment with Harvoni for patients with Hepatitis C (HCV) and HCV-associated CKD~Subjects were followed for one year after treatment initiation"
11243471|NCT02503735|FG000|Participant Flow|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)
11243472|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)~Proteinuria is assessed at baseline (initiation of treatment) and at 24 weeks after baseline (12 weeks after completion of treatment."
11243473|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)~We determined the median change in eGFR as measured by creatinine and cystatin C equation from baseline to timepoint week 24 (12 weeks after completion of treatment)"
11243474|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants received Sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)~We want to determine the number of participants with at least a 25% Reduction in Proteinuria"
11243475|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)~The time to maximum reduction in proteinuria was assessed for each participant and compiled, and a mean is presented"
11243476|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants HCV and proteinuria received 12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)~The median change in eGFR from baseline to timepoint week 52 was determined, as measured by the creatinine and cystatin C-based estimating equation"
11243477|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg) for patients with HCV and HCV-associated CKD
11243478|NCT02503735|OG000|Outcome|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Participants with HCV and proteinuria received 12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)~Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill~β-2microglobulin (mcg/L) levels were measured at baseline and at timepoint week 24"
11243479|NCT02503735|EG000|Reported Event|12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)|"Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)~Patients were followed for one year following treatment initiation"
11243480|NCT02503787|BG000|Baseline|Open Label Treatment|Spinal Cord Stimulation (SCS)
11243481|NCT02503787|FG000|Participant Flow|Open Label Treatment|Spinal Cord Stimulation (SCS)
11243482|NCT02503787|OG000|Outcome|Open Label Treatment|Spinal Cord Stimulation (SCS)
11202765|NCT02209454|FG001|Participant Flow|Test IMP First, Then Reference IMP|25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
11202766|NCT02209454|OG000|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
11202767|NCT02209454|OG001|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
11202768|NCT02209454|EG000|Reported Event|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
11202769|NCT02209454|EG001|Reported Event|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
11202770|NCT02209506|BG000|Baseline|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202771|NCT02209506|BG001|Baseline|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202772|NCT02209506|BG002|Baseline|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202773|NCT02209506|BG003|Baseline|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202774|NCT02209506|BG004|Baseline|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202775|NCT02209506|BG005|Baseline|Total|Total of all reporting groups
11202776|NCT02209506|FG000|Participant Flow|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202777|NCT02209506|FG001|Participant Flow|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202778|NCT02209506|FG002|Participant Flow|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202779|NCT02209506|FG003|Participant Flow|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202780|NCT02209506|FG004|Participant Flow|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202781|NCT02209506|OG000|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202782|NCT02209506|OG001|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202783|NCT02209506|OG002|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202784|NCT02209506|OG003|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202785|NCT02209506|OG004|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202786|NCT02209506|OG000|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202787|NCT02209506|OG001|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202788|NCT02209506|OG002|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202789|NCT02209506|EG000|Reported Event|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202790|NCT02209506|EG001|Reported Event|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11243483|NCT02503787|EG000|Reported Event|Device: Neurostimulator|"RestoreSensor SureScan MRI Rechargeable Neurostimulator~RestoreSensor SureScan MRI Rechargeable Neurostimulator: RestoreSensor SureScan MRI Rechargeable Neurostimulator"
11243484|NCT02503852|BG000|Baseline|Fat + High Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243485|NCT02503852|BG001|Baseline|Fat + Low Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243486|NCT02503852|BG002|Baseline|Fat Alone|"Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243487|NCT02503852|BG003|Baseline|No Fat Control|"Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243488|NCT02503852|BG004|Baseline|Total|Total of all reporting groups
11243489|NCT02503852|FG000|Participant Flow|Fat + High Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243490|NCT02503852|FG001|Participant Flow|Fat + Low Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243491|NCT02503852|FG002|Participant Flow|Fat Alone|"Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243492|NCT02503852|FG003|Participant Flow|No Fat Control|"Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11286125|NCT02883452|EG003|Reported Event|Cohort 4: CT-P13 SC 240 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
11202791|NCT02209506|EG002|Reported Event|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11243493|NCT02503852|OG000|Outcome|Fat + High Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243494|NCT02503852|OG001|Outcome|Fat + Low Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243495|NCT02503852|OG002|Outcome|Fat Alone|"Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243496|NCT02503852|OG003|Outcome|No Fat Control|"Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243497|NCT02503852|EG000|Reported Event|Fat + High Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243498|NCT02503852|EG001|Reported Event|Fat + Low Dose ADRC|"Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.~Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243499|NCT02503852|EG002|Reported Event|Fat Alone|"Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.~Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243500|NCT02503852|EG003|Reported Event|No Fat Control|"Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.~Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue."
11243501|NCT02503865|BG000|Baseline|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
11243502|NCT02503865|BG001|Baseline|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
11243503|NCT02503865|BG002|Baseline|Healthy People|64 healthy people
11243504|NCT02503865|BG003|Baseline|Total|Total of all reporting groups
11243505|NCT02503865|FG000|Participant Flow|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
11243506|NCT02503865|FG001|Participant Flow|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
11243507|NCT02503865|FG002|Participant Flow|Healthy People|64 healthy people
11243508|NCT02503865|OG000|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
11243509|NCT02503865|OG001|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
11243510|NCT02503865|OG002|Outcome|Healthy People|64 healthy people
11243511|NCT02503865|OG001|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
11243512|NCT02503865|EG000|Reported Event|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
11243513|NCT02503865|EG001|Reported Event|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
11243514|NCT02503865|EG002|Reported Event|Healthy People|64 healthy people
11243515|NCT02503982|BG000|Baseline|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
11202792|NCT02209506|EG003|Reported Event|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11243516|NCT02503982|FG000|Participant Flow|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
11243517|NCT02503982|OG000|Outcome|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
11243518|NCT02503982|EG000|Reported Event|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
11243519|NCT02504073|BG000|Baseline|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
11243520|NCT02504073|FG000|Participant Flow|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
11243521|NCT02504073|OG000|Outcome|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
11243522|NCT02504073|OG000|Outcome|PT's Working in Stroke in NW-Switzerland|"54 Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.~There is no intervention.~No intervention: No intervention"
11243523|NCT02504073|EG000|Reported Event|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
11243524|NCT02504216|BG000|Baseline|Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
11243525|NCT02504216|BG001|Baseline|Rivaroxaban Placebo Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
11243526|NCT02504216|BG002|Baseline|Total|Total of all reporting groups
11243527|NCT02504216|FG000|Participant Flow|Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
11243528|NCT02504216|FG001|Participant Flow|Rivaroxaban Placebo Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
11243529|NCT02504216|OG000|Outcome|Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
11243530|NCT02504216|OG001|Outcome|Rivaroxaban Placebo Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
11243531|NCT02504216|EG000|Reported Event|Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
11243532|NCT02504216|EG001|Reported Event|Rivaroxaban Placebo Bid + Aspirin 100 mg od|Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
11243533|NCT02504268|BG000|Baseline|Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)|Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243534|NCT02504268|BG001|Baseline|Placebo + Methotrexate (Cohort 1, IP)|Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243535|NCT02504268|BG002|Baseline|Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)|Active abatacept SC (125 mg) weekly + methotrexate weekly
11243536|NCT02504268|BG003|Baseline|Total|Total of all reporting groups
11243537|NCT02504268|FG000|Participant Flow|Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)|Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243538|NCT02504268|FG001|Participant Flow|Placebo + Methotrexate (Cohort 1, IP)|Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243539|NCT02504268|FG002|Participant Flow|Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)|Active abatacept SC (125 mg) weekly + methotrexate weekly
11243540|NCT02504268|FG003|Participant Flow|Abatacept + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + MTX weekly
11243541|NCT02504268|FG004|Participant Flow|Abatacept (End of Week) + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
11243542|NCT02504268|FG005|Participant Flow|Abatacept Monotherapy (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + placebo MTX weekly
11243543|NCT02504268|FG006|Participant Flow|Methotrexate Monotherapy (De-Escalation Period)|Placebo Abatacept SC weekly + methotrexate weekly
11243544|NCT02504268|FG007|Participant Flow|Abatacept + Methotrexate (Open Label Period)|weekly abatacept SC 125 mg + methotrexate
11202793|NCT02209506|EG004|Reported Event|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
11202794|NCT02209519|BG000|Baseline|Metronidazole|"Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days~Metronidazole (male partner): 500 mg PO BID for 7 days"
11202795|NCT02209519|BG001|Baseline|Placebo|"Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days~Placebo (male partner): matching placebo capsules PO BID for 7 days"
11202796|NCT02209519|BG002|Baseline|Total|Total of all reporting groups
11202797|NCT02209519|FG000|Participant Flow|Metronidazole|"Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days~Metronidazole (male partner): 500 mg PO BID for 7 days"
11202798|NCT02209519|FG001|Participant Flow|Placebo|"Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days~Placebo (male partner): matching placebo capsules PO BID for 7 days"
11202799|NCT02209519|OG000|Outcome|Metronidazole|"Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days~Metronidazole (male partner): 500 mg PO BID for 7 days"
11202800|NCT02209519|OG001|Outcome|Placebo|"Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days~Placebo (male partner): matching placebo capsules PO BID for 7 days"
11202801|NCT02209519|OG001|Outcome|Placebo|"Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days~Placeob (male partner): matching placebo capsules PO BID for 7 days"
11202802|NCT02209519|EG000|Reported Event|Metronidazole|"Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days~Metronidazole (male partner): 500 mg PO BID for 7 days"
11202803|NCT02209519|EG001|Reported Event|Placebo|"Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days~Placebo (male partner): matching placebo capsules PO BID for 7 days"
11202804|NCT02209532|BG000|Baseline|Blue - PINPOINT|"The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202805|NCT02209532|BG001|Baseline|PINPOINT - Blue|"The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202806|NCT02209532|BG002|Baseline|Total|Total of all reporting groups
11202807|NCT02209532|FG000|Participant Flow|Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT|"The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202808|NCT02209532|FG001|Participant Flow|Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue|"The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202809|NCT02209532|OG000|Outcome|PINPOINT - Blue|"The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11215340|NCT02298803|OG000|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis.
11243545|NCT02504268|FG008|Participant Flow|Abatacept + Methotrexate (Open Label Extension Period)|abatacept SC (125 mg) qw for 24 weeks
11202810|NCT02209532|OG001|Outcome|Blue - PINPOINT|"The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202811|NCT02209532|OG000|Outcome|PINPOINT-Blue|"The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202812|NCT02209532|EG000|Reported Event|Blue - PINPOINT|"The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202813|NCT02209532|EG001|Reported Event|PINPOINT - Blue|"The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.~PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes"
11202814|NCT02209597|BG000|Baseline|Bupropion|"Subjects will be studied for 28 weeks in a sequential cross-over study:~a 4-week lead-in phase during which all participants remain on their existing bupropion product~Four randomized cross-over phases of 6 weeks on each of the four bupropion study drugs (brand Wellbutrin 300mg XL, Valeant, Par and Watson 3 generics)"
11202815|NCT02209597|FG000|Participant Flow|Bupropion|"Phase 1: (Non-randomized) an approximately 4-week lead-in phase during which participants remain on their existing bupropion product~Other Names:~Wellbutrin Par Mylan Valeant"
11202816|NCT02209597|OG000|Outcome|Valeant Brand Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202817|NCT02209597|OG001|Outcome|Par Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202818|NCT02209597|OG002|Outcome|Watson Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202819|NCT02209597|OG003|Outcome|Mylan Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202820|NCT02209597|EG000|Reported Event|Valeant Brand Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202821|NCT02209597|EG001|Reported Event|PAR Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202822|NCT02209597|EG002|Reported Event|Watson Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202823|NCT02209597|EG003|Reported Event|Mylan Generic Bupropion XL® 300mg|Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
11202824|NCT02209610|BG000|Baseline|Patients With Heart Failure: Neuromuscular Abnormalities|"Patients with Heart Failure~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202825|NCT02209610|BG001|Baseline|Health Control Subjects and Neuromuscular Function|"Health Control Subjects~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202826|NCT02209610|BG002|Baseline|Total|Total of all reporting groups
11202827|NCT02209610|FG000|Participant Flow|Patients With Heart Failure: Neuromuscular Abnormalities|"Patients with Heart Failure are characterized by excessive exercise-induced neuromuscular fatigue Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11243546|NCT02504268|OG000|Outcome|Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)|Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11202828|NCT02209610|FG001|Participant Flow|Health Control Subjects and Neuromuscular Function|"Health Control Subjects~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11243547|NCT02504268|OG001|Outcome|Placebo + Methotrexate (Cohort 1, IP)|Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243548|NCT02504268|OG002|Outcome|Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)|Active abatacept SC (125 mg) weekly + methotrexate weekly
11243549|NCT02504268|OG003|Outcome|Abatacept + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + MTX weekly
11243550|NCT02504268|OG004|Outcome|Abatacept (End of Week) + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
11243551|NCT02504268|OG005|Outcome|Abatacept Monotherapy (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + placebo MTX weekly
11243552|NCT02504268|OG006|Outcome|Methotrexate Monotherapy (De-Escalation Period)|Placebo Abatacept SC weekly + methotrexate weekly
11243553|NCT02504268|OG007|Outcome|Abatacept + Methotrexate (Open Label Period)|weekly abatacept SC 125 mg + methotrexate
10970611|NCT00911170|FG000|Participant Flow|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
11243554|NCT02504268|OG008|Outcome|Abatacept + Methotrexate (Open Label Extension Period)|abatacept SC (125 mg) qw for 24 weeks
11243555|NCT02504268|EG000|Reported Event|Combination Therapy: Abatacept + Methotrexate (Cohort 1, IP)|Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243556|NCT02504268|EG001|Reported Event|Placebo + Methotrexate (Cohort 1, IP)|Placebo of Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
11243557|NCT02504268|EG002|Reported Event|Combination Therapy: Abatacept + Methotrexate (Cohort 2, IP)|Active abatacept SC (125 mg) weekly + methotrexate weekly
11243558|NCT02504268|EG003|Reported Event|Abatacept + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + MTX weekly
11243559|NCT02504268|EG004|Reported Event|Abatacept (End of Week) + Methotrexate (De-Escalation Period)|Active Abatacept SC (125 mg) alternating with placebo for abatacept every other week + MTX weekly
11243560|NCT02504268|EG005|Reported Event|Abatacept Monotherapy (De-Escalation Period)|Active Abatacept SC (125 mg) weekly + placebo MTX weekly
11243561|NCT02504268|EG006|Reported Event|Methotrexate Monotherapy (De-Escalation Period)|Placebo Abatacept SC weekly + methotrexate weekly
11243562|NCT02504268|EG007|Reported Event|Abatacept + Methotrexate (Open Label Period)|weekly abatacept SC 125 mg + methotrexate
11243563|NCT02504268|EG008|Reported Event|Abatacept + Methotrexate (Open Label Extension Period)|abatacept SC (125 mg) qw for 24 weeks
11243564|NCT02504294|BG000|Baseline|Epoetin Hospira|Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243565|NCT02504294|BG001|Baseline|Epogen|Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243566|NCT02504294|BG002|Baseline|Total|Total of all reporting groups
11243567|NCT02504294|FG000|Participant Flow|Epoetin Hospira|Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243568|NCT02504294|FG001|Participant Flow|Epogen|Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243569|NCT02504294|OG000|Outcome|Epoetin Hospira|Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243570|NCT02504294|OG001|Outcome|Epogen|Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243571|NCT02504294|EG000|Reported Event|Epoetin Hospira|Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243572|NCT02504294|EG001|Reported Event|Epogen|Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
11243573|NCT02504320|BG000|Baseline|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
11202829|NCT02209610|OG000|Outcome|Patients With Heart Failure: Neuromuscular Abnormalities|"Patients with Heart Failure~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202830|NCT02209610|OG001|Outcome|Health Control Subjects and Neuromuscular Function|"Health Control Subjects~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202831|NCT02209610|OG000|Outcome|Patients With Heart Failure: Neuromuscular Abnormalities|"Patients with Heart Failure are characterized by excessive exercise-induced neuromuscular fatigue Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202832|NCT02209610|EG000|Reported Event|Patients With Heart Failure: Neuromuscular Abnormalities|"Patients with Heart Failure~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202833|NCT02209610|EG001|Reported Event|Health Control Subjects and Neuromuscular Function|"Health Control Subjects~Electrical and Magnetic Nerve Stimulators: Stimulation of motor nerve and central nervous system~Intrathecal Fentanyl: Mu-opioid receptor agonist"
11202834|NCT02209766|BG000|Baseline|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202835|NCT02209766|BG001|Baseline|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202836|NCT02209766|BG002|Baseline|4 g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
11202837|NCT02209766|BG003|Baseline|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
11202838|NCT02209766|BG004|Baseline|Total|Total of all reporting groups
11202839|NCT02209766|FG000|Participant Flow|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202840|NCT02209766|FG001|Participant Flow|2 g D5884 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
11202841|NCT02209766|FG002|Participant Flow|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202842|NCT02209766|FG003|Participant Flow|4g D5844 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
11202843|NCT02209766|FG004|Participant Flow|4g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
11202844|NCT02209766|OG000|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202845|NCT02209766|OG001|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
11202846|NCT02209766|OG002|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
11202847|NCT02209766|OG003|Outcome|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
11202848|NCT02209766|EG000|Reported Event|2 g D4884 Japanese|
11202849|NCT02209766|EG001|Reported Event|4 g D4884 Japanese|
11202850|NCT02209766|EG002|Reported Event|4 g D4884 Caucasian|
11202851|NCT02209766|EG003|Reported Event|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
11202852|NCT02209948|BG000|Baseline|Temozolomide|Temozolomide dose 150/200 mg/m2/d for 5 days every 28 days for 6 cycles (total 12 cycles of adjuvant temozolomide).
11202853|NCT02209948|BG001|Baseline|Without Treatment|No treatment (total 6 cycles of adjuvant Temozolomide).
11202854|NCT02209948|BG002|Baseline|Total|Total of all reporting groups
11202855|NCT02209948|FG000|Participant Flow|Temozolomide|Temozolomide dose 150/200 mg/m2/d for 5 days every 28 days for 6 cycles (total 12 cycles of adjuvant temozolomide).
11202856|NCT02209948|FG001|Participant Flow|Without Treatment|No treatment (total 6 cycles of adjuvant Temozolomide).
11202857|NCT02209948|OG000|Outcome|Temozolomide|Temozolomide dose 150/200 mg/m2/d for 5 days every 28 days for 6 cycles (total 12 cycles of adjuvant temozolomide).
11202858|NCT02209948|OG001|Outcome|Without Treatment|No treatment (total 6 cycles of adjuvant Temozolomide).
11202859|NCT02209948|EG000|Reported Event|Temozolomide|Temozolomide dose 150/200 mg/m2/d for 5 days every 28 days for 6 cycles (total 12 cycles of adjuvant temozolomide).
11202860|NCT02209948|EG001|Reported Event|Without Treatment|No treatment (total 6 cycles of adjuvant Temozolomide).
11202861|NCT02210000|BG000|Baseline|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202862|NCT02210000|BG001|Baseline|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202863|NCT02210000|BG002|Baseline|Total|Total of all reporting groups
11202864|NCT02210000|FG000|Participant Flow|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 milligrams (mg) once daily in the morning with 100 milliliter (mL) of water up to 84 days and were followed-up for 2 weeks.
11202865|NCT02210000|FG001|Participant Flow|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202866|NCT02210000|OG000|Outcome|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202867|NCT02210000|OG001|Outcome|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202868|NCT02210000|EG000|Reported Event|CAMICINAL 25 MG|Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202869|NCT02210000|EG001|Reported Event|PLACEBO|Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.
11202870|NCT02210039|BG000|Baseline|SECM Probe Imaging|"SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.~SECM Probe: Imaging of the esophagus using SECM probe and system."
11202871|NCT02210039|FG000|Participant Flow|SECM Probe Imaging|"SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.~SECM Probe: Imaging of the esophagus using SECM probe and system."
11202872|NCT02210039|OG000|Outcome|SECM Probe Imaging|"SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.~SECM Probe: Imaging of the esophagus using SECM probe and system."
11202873|NCT02210039|EG000|Reported Event|SECM Probe Imaging|"SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.~SECM Probe: Imaging of the esophagus using SECM probe and system.~No adverse events has been reported."
11202874|NCT02210052|BG000|Baseline|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
11202875|NCT02210052|FG000|Participant Flow|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
11202876|NCT02210052|OG000|Outcome|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
11202877|NCT02210052|EG000|Reported Event|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
11202878|NCT02210065|BG000|Baseline|Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)|"CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.~Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg."
11202879|NCT02210065|FG000|Participant Flow|Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)|"CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.~Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg."
11202880|NCT02210065|OG000|Outcome|Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)|"CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.~Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg."
11202881|NCT02210065|EG000|Reported Event|Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)|"CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.~Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg."
11202882|NCT02210091|BG000|Baseline|<6 Years Old|
11202883|NCT02210091|BG001|Baseline|6 to <12 Years Old|
11202884|NCT02210091|BG002|Baseline|Total|Total of all reporting groups
11202885|NCT02210091|FG000|Participant Flow|<6 Years Old|
11202886|NCT02210091|FG001|Participant Flow|6 to <12 Years Old|
11202887|NCT02210091|OG000|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
11202888|NCT02210091|OG001|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
11202889|NCT02210091|OG002|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
11202890|NCT02210091|OG000|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
11202891|NCT02210091|OG001|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
11202892|NCT02210091|OG002|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
11202893|NCT02210091|OG000|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
11202894|NCT02210091|OG002|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855.
11202895|NCT02210091|OG000|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202896|NCT02210091|OG001|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years olde who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202897|NCT02210091|OG002|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202898|NCT02210091|OG000|Outcome|Overall Study Arm|
11202899|NCT02210091|OG001|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202900|NCT02210091|OG000|Outcome|PK Analysis Set <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202901|NCT02210091|OG000|Outcome|<6 Years Old|
11202902|NCT02210091|OG001|Outcome|6 to <12 Years Old|
11202903|NCT02210091|OG002|Outcome|Full Analysis Set|
10966784|NCT00889187|OG000|Outcome|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
11092484|NCT01540266|BG003|Baseline|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092485|NCT01540266|BG004|Baseline|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092486|NCT01540266|BG005|Baseline|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092487|NCT01540266|BG006|Baseline|Total|Total of all reporting groups
11092488|NCT01540266|FG000|Participant Flow|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092489|NCT01540266|FG001|Participant Flow|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092490|NCT01540266|FG002|Participant Flow|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092491|NCT01540266|FG003|Participant Flow|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092492|NCT01540266|FG004|Participant Flow|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092493|NCT01540266|FG005|Participant Flow|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092494|NCT01540266|OG000|Outcome|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092495|NCT01540266|OG001|Outcome|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092496|NCT01540266|OG002|Outcome|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092497|NCT01540266|OG003|Outcome|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092498|NCT01540266|OG004|Outcome|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092499|NCT01540266|OG005|Outcome|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092500|NCT01540266|EG000|Reported Event|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11286126|NCT02883452|EG004|Reported Event|Arm 1: CT-P13 SC 120/240 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
10804103|NCT04311177|BG000|Baseline|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 25 mg daily; oral administration"
11202904|NCT02210091|OG000|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
11202905|NCT02210091|EG000|Reported Event|BAX 855 Safety Analysis Set|Participants who received at least 1 dose of BAX 855.
11202906|NCT02210091|EG001|Reported Event|ADVATE Received Before BAX 855|Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study.
11202907|NCT02210195|BG000|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202908|NCT02210195|BG001|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202909|NCT02210195|BG002|Baseline|Total|Total of all reporting groups
11202910|NCT02210195|FG000|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202911|NCT02210195|FG001|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202912|NCT02210195|OG000|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202913|NCT02210195|OG001|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202914|NCT02210195|EG000|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202915|NCT02210195|EG001|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
11202916|NCT02210208|BG000|Baseline|All Participants|"All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a Donor site to help the burn wound heal. The Donor site was also treated and these patients were included i part B."
11202917|NCT02210208|FG000|Participant Flow|Overall Study|Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients
11202918|NCT02210208|OG000|Outcome|Part A: Mepitel Ag|"Mepitel Ag treatment on burn wounds with skin grafts~Mepitel Ag"
11202919|NCT02210208|OG000|Outcome|Part B: Mepilex Transfer Ag|Mepilex Transfer Ag treatment at donor site for skin graft.
11202920|NCT02210208|OG000|Outcome|Mepitel Ag|Mepitel Ag treatment on skin graft over surgical burn wounds.
11202921|NCT02210208|EG000|Reported Event|Overall Study|Mepitel Ag treatment and Mepilex Transfer Ag
11202922|NCT02210221|BG000|Baseline|CENTER-TBI Population|Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
11202923|NCT02210221|FG000|Participant Flow|CENTER-TBI Population|Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study and from 22 782 patients in the registry. In the core study, 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum.
11202924|NCT02210221|OG000|Outcome|CENTER-TBI Population|Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
11202925|NCT02210221|OG001|Outcome|ER Stratum|patients admitted to the ER
11202926|NCT02210221|OG002|Outcome|Admission Stratum|patients admitted but not to the ICU
11202927|NCT02210221|OG003|Outcome|ICU Stratum|patients admitted to the ICU
11202928|NCT02210221|OG001|Outcome|ER Stratum|patients in the ER
11202929|NCT02210221|OG001|Outcome|ER Stratum|patients at the ER
11202930|NCT02210221|EG000|Reported Event|CENTER-TBI Population|Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
11202931|NCT02210247|BG000|Baseline|Cohort 1|"Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given.~EXPAREL"
11202932|NCT02210247|BG001|Baseline|Cohort 2|"Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.~EXPAREL"
11202933|NCT02210247|BG002|Baseline|Cohort 3|"Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.~EXPAREL"
11202934|NCT02210247|BG003|Baseline|Cohort 4|"Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.~EXPAREL"
11202935|NCT02210247|BG004|Baseline|Cohort 5|"Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).~EXPAREL"
11202936|NCT02210247|BG005|Baseline|Total|Total of all reporting groups
11202937|NCT02210247|FG000|Participant Flow|Cohort 1|"Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given.~EXPAREL"
11202938|NCT02210247|FG001|Participant Flow|Cohort 2|"Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.~EXPAREL"
11202939|NCT02210247|FG002|Participant Flow|Cohort 3|"Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.~EXPAREL"
11202940|NCT02210247|FG003|Participant Flow|Cohort 4|"Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.~EXPAREL"
11202941|NCT02210247|FG004|Participant Flow|Cohort 5|"Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).~EXPAREL"
11202942|NCT02210247|OG000|Outcome|Cohort 1|"Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given.~EXPAREL"
11202943|NCT02210247|OG001|Outcome|Cohort 2|"Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.~EXPAREL"
11202944|NCT02210247|OG002|Outcome|Cohort 3|"Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.~EXPAREL"
11202945|NCT02210247|OG003|Outcome|Cohort 4|"Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.~EXPAREL"
11202946|NCT02210247|OG004|Outcome|Cohort 5|"Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).~EXPAREL"
11202947|NCT02210247|OG000|Outcome|Cohort 1|"Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given.~EXPAREL"
11202948|NCT02210247|OG001|Outcome|Cohort 2|"Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.~EXPAREL"
11202949|NCT02210247|OG002|Outcome|Cohort 3|"Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.~EXPAREL"
10804104|NCT04311177|BG001|Baseline|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11202950|NCT02210247|OG003|Outcome|Cohort 4|"Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.~EXPAREL"
11202951|NCT02210247|OG004|Outcome|Cohort 5|"Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).~EXPAREL"
10804105|NCT04311177|BG002|Baseline|Total|Total of all reporting groups
10804106|NCT04311177|FG000|Participant Flow|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 25 mg daily; oral administration"
11202952|NCT02210247|EG000|Reported Event|Cohort 1|"Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given.~EXPAREL"
11202953|NCT02210247|EG001|Reported Event|Cohort 2|"Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.~EXPAREL"
11202954|NCT02210247|EG002|Reported Event|Cohort 3|"Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.~EXPAREL"
11202955|NCT02210247|EG003|Reported Event|Cohort 4|"Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.~EXPAREL"
11202956|NCT02210247|EG004|Reported Event|Cohort 5|"Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).~EXPAREL"
11202957|NCT02210286|BG000|Baseline|Magtein Subjects|Inclusion criteria included adults of either gender > 60 years of age (women had to be post-menopausal), a diagnosis of probable AD from their physician, a Mini-Mental State Examination (MMSE) between 14 and 24, adequate visual and auditory acuity to allow for neuropsychological testing, at least 12 years of education (or a GED to allow consistency of the sample), and willingness to or having a representative willing to sign the informed consent prior to enrollment into the study (for those subjects unable to sign or understand informed consent, assent to participate in the study was required), and agreeing to discontinue vitamins, minerals, or dietary/herbal supplements for at least 7 days prior to study entry and until after study completion.
11202958|NCT02210286|FG000|Participant Flow|Magtein|17 subjects were then enrolled into the study
11202959|NCT02210286|OG000|Outcome|Magtein Cognitive Data|Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
11202960|NCT02210286|OG000|Outcome|Change From Baseline in Cognitive Function (DKEFS)|Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
11202961|NCT02210286|OG000|Outcome|Change From Baseline in Cognitive Function (DKEFS - Trail 4)|Participants were assessed with the ADAS-Cog, MMSE, D-KEFS RBANS, and WAIS-IV neuropsychological assessments. We hypothesized improvements in cognitive scores with MMFS-201-101 treatment.
11202962|NCT02210286|OG000|Outcome|Change in CMRgl From Baseline|We examined CMRgl changes using our summary index statistical region of interest (sROI) which is free of the multiple comparison concern.
11202963|NCT02210286|OG000|Outcome|Change in RBC Magnesium|Change in the amount of magnesium in red blood cells (mg/dl) from baseline
11202964|NCT02210286|EG000|Reported Event|Magtein Adverse Events|See Table below for details on adverse event.
11202965|NCT02210689|BG000|Baseline|Generic Clindamycin Phosphate Vaginal Cream 2%|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202966|NCT02210689|BG001|Baseline|Clindesse (Clindamycin Phosphate Vaginal Cream 2%)|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202967|NCT02210689|BG002|Baseline|Vehicle Cream|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202968|NCT02210689|BG003|Baseline|Total|Total of all reporting groups
11202969|NCT02210689|FG000|Participant Flow|Generic Clindamycin Phosphate Vaginal Cream 2%|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202970|NCT02210689|FG001|Participant Flow|Clindesse (Clindamycin Phosphate Vaginal Cream 2%)|One single-dose, pre-filled, disposable applicator of Investigational product to be administered intravaginally at home.
11202971|NCT02210689|FG002|Participant Flow|Vehicle Cream|One single-dose, pre-filled, disposable applicator of Investigational product was to be inserted intravaginally at home.
11202972|NCT02210689|OG000|Outcome|Test Product|"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)~clindamycin phosphate vaginal cream 2%"
11202973|NCT02210689|OG001|Outcome|Reference Product|"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)~clindamycin phosphate vaginal cream 2%"
11202974|NCT02210689|OG002|Outcome|Placebo|"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)~placebo: vehicle used as placebo"
11202975|NCT02210689|EG000|Reported Event|Generic Clindamycin Phosphate Vaginal Cream 2%|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202976|NCT02210689|EG001|Reported Event|Clindesse (Clindamycin Phosphate Vaginal Cream 2%)|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202977|NCT02210689|EG002|Reported Event|Vehicle Cream|One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
11202978|NCT02210780|BG000|Baseline|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11202979|NCT02210780|BG001|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11202980|NCT02210780|BG002|Baseline|Total|Total of all reporting groups
11202981|NCT02210780|FG000|Participant Flow|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11202982|NCT02210780|FG001|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11202983|NCT02210780|OG000|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11202984|NCT02210780|OG001|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11202985|NCT02210780|EG000|Reported Event|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11202986|NCT02210780|EG001|Reported Event|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
11202987|NCT02211014|BG000|Baseline|Cohort 1|Acalabrutinib 100 mg twice daily (bid) continuously
11202988|NCT02211014|BG001|Baseline|Cohort 2|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11202989|NCT02211014|BG002|Baseline|Total|Total of all reporting groups
11202990|NCT02211014|FG000|Participant Flow|Cohort 1|Acalabrutinib 100 mg twice daily (bid) continuously
11202991|NCT02211014|FG001|Participant Flow|Cohort 2|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11202992|NCT02211014|OG000|Outcome|Cohort 1|Acalabrutinib 100 mg twice daily (bid) continuously
11202993|NCT02211014|OG001|Outcome|Cohort 2|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11202994|NCT02211014|OG000|Outcome|Cohort 1 - Day 1|Acalabrutinib 100 mg twice daily (bid) continuously
11202995|NCT02211014|OG001|Outcome|Cohort 2 - Day 1|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11202996|NCT02211014|OG002|Outcome|Cohort 1 - Day 22|Acalabrutinib 100 mg twice daily (bid) continuously
11202997|NCT02211014|OG003|Outcome|Cohort 2 - Day 22|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11202998|NCT02211014|OG000|Outcome|Cohort 1 - Day 1 Pre|Acalabrutinib 100 mg twice daily (bid) continuously
11202999|NCT02211014|OG001|Outcome|Cohort 2 - Day 1 Pre|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203000|NCT02211014|OG002|Outcome|Cohort 1 - Day 1 Post|Acalabrutinib 100 mg twice daily (bid) continuously
11203001|NCT02211014|OG003|Outcome|Cohort 2 - Day 1 Post|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203002|NCT02211014|OG004|Outcome|Cohort 1 - Day 8 Pre|Acalabrutinib 100 mg twice daily (bid) continuously
11203003|NCT02211014|OG005|Outcome|Cohort 2 - Day 8 Pre|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203004|NCT02211014|OG006|Outcome|Cohort 1 - Day 8 Post|Acalabrutinib 100 mg twice daily (bid) continuously
11203005|NCT02211014|OG007|Outcome|Cohort 2 - Day 8 Post|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203006|NCT02211014|OG008|Outcome|Cohort 1 - Day 28 Pre|Acalabrutinib 100 mg twice daily (bid) continuously
11203007|NCT02211014|OG009|Outcome|Cohort 2 - Day 28 Pre|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203008|NCT02211014|OG010|Outcome|Cohort 1 - Day 56 Pre|Acalabrutinib 100 mg twice daily (bid) continuously
11203009|NCT02211014|OG011|Outcome|Cohort 2 - Day 56 Pre|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203010|NCT02211014|EG000|Reported Event|Cohort 1|Acalabrutinib 100 mg twice daily (bid) continuously
11203011|NCT02211014|EG001|Reported Event|Cohort 2|Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
11203012|NCT02211261|BG000|Baseline|Placebo SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203013|NCT02211261|BG001|Baseline|PF-06293620 0.3 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203014|NCT02211261|BG002|Baseline|PF-06293620 1.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203015|NCT02211261|BG003|Baseline|PF-06293620 3.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203016|NCT02211261|BG004|Baseline|PF-06293620 6.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203017|NCT02211261|BG005|Baseline|Placebo IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203018|NCT02211261|BG006|Baseline|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203019|NCT02211261|BG007|Baseline|Placebo SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203020|NCT02211261|BG008|Baseline|PF-06293620 50 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203021|NCT02211261|BG009|Baseline|PF-06293620 75 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203022|NCT02211261|BG010|Baseline|PF-06293620 150 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203023|NCT02211261|BG011|Baseline|Total|Total of all reporting groups
11243574|NCT02504320|BG001|Baseline|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
11243575|NCT02504320|BG002|Baseline|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
11243576|NCT02504320|BG003|Baseline|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
11243577|NCT02504320|BG004|Baseline|Total|Total of all reporting groups
11243578|NCT02504320|FG000|Participant Flow|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
11243579|NCT02504320|FG001|Participant Flow|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
11243580|NCT02504320|FG002|Participant Flow|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
11243581|NCT02504320|FG003|Participant Flow|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
11243582|NCT02504320|OG000|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243583|NCT02504320|OG001|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243584|NCT02504320|OG002|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243585|NCT02504320|OG003|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243586|NCT02504320|EG000|Reported Event|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243587|NCT02504320|EG001|Reported Event|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243588|NCT02504320|EG002|Reported Event|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243589|NCT02504320|EG003|Reported Event|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
11243590|NCT02504424|BG000|Baseline|AeroForm Tissue Expander|"AeroForm Tissue Expansion inflation with carbon dioxide gas by remote control~AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11243591|NCT02504424|FG000|Participant Flow|AeroForm Tissue Expander|"AeroForm Tissue Expansion inflation with carbon dioxide gas by remote control~AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide gas from an internal reservoir to fill and inflate the expander."
11243592|NCT02504424|OG000|Outcome|AeroForm Tissue Expander|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control~AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
11243593|NCT02504424|OG000|Outcome|AeroForm Tissue Expander|"AeroForm Tissue Expansion inflation with carbon dioxide gas by remote control~AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide gas from an internal reservoir to fill and inflate the expander."
11243594|NCT02504424|EG000|Reported Event|AeroForm Tissue Expander|"AeroForm Tissue Expansion inflation with carbon dioxide gas by remote control~AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide gas from an internal reservoir to fill and inflate the expander."
11203024|NCT02211261|FG000|Participant Flow|Placebo SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
10970612|NCT00911170|FG001|Participant Flow|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
10804107|NCT04311177|FG001|Participant Flow|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11203025|NCT02211261|FG001|Participant Flow|PF-06293620 0.3 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203026|NCT02211261|FG002|Participant Flow|PF-06293620 1.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203027|NCT02211261|FG003|Participant Flow|PF-06293620 3.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203028|NCT02211261|FG004|Participant Flow|PF-06293620 6.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
10804108|NCT04311177|OG000|Outcome|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 25 mg daily; oral administration"
11092501|NCT01540266|EG001|Reported Event|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11203029|NCT02211261|FG005|Participant Flow|Placebo IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203030|NCT02211261|FG006|Participant Flow|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203031|NCT02211261|FG007|Participant Flow|Placebo SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203032|NCT02211261|FG008|Participant Flow|PF-06293620 50 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203033|NCT02211261|FG009|Participant Flow|PF-06293620 75 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203034|NCT02211261|FG010|Participant Flow|PF-06293620 150 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203035|NCT02211261|OG000|Outcome|Placebo SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203036|NCT02211261|OG001|Outcome|PF-06293620 0.3 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203037|NCT02211261|OG002|Outcome|PF-06293620 1.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203038|NCT02211261|OG003|Outcome|PF-06293620 3.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203039|NCT02211261|OG004|Outcome|PF-06293620 6.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203040|NCT02211261|OG005|Outcome|Placebo IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203041|NCT02211261|OG006|Outcome|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203042|NCT02211261|OG007|Outcome|Placebo SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203043|NCT02211261|OG008|Outcome|PF-06293620 50 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203044|NCT02211261|OG009|Outcome|PF-06293620 75 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203045|NCT02211261|OG010|Outcome|PF-06293620 150 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203046|NCT02211261|OG000|Outcome|PF-06293620 0.3 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203047|NCT02211261|OG001|Outcome|PF-06293620 1.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203048|NCT02211261|OG002|Outcome|PF-06293620 3.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203049|NCT02211261|OG003|Outcome|PF-06293620 6.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11092502|NCT01540266|EG002|Reported Event|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11243595|NCT02504502|BG000|Baseline|Control With Delayed Access|"Those resulting in variants of significance will receive routine clinical care and receive the enhanced genomic report after returning 3 month survey.~Routine Clinical Care: Participants will receive routine clinical care. After returning the 3 month survey the participants will also receive the enhanced genomic report."
11243596|NCT02504502|BG001|Baseline|Enhanced Genomic Report|"Those resulting in variants of significance will received routine clinical care and access to the enhanced genomic lab report.~Enhanced Genomic Report: Routine clinical care vs. enhanced genomic report"
11243597|NCT02504502|BG002|Baseline|Total|Total of all reporting groups
11243598|NCT02504502|FG000|Participant Flow|Routine Care With Delayed Access to Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
11243599|NCT02504502|FG001|Participant Flow|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
11243600|NCT02504502|OG000|Outcome|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
11203050|NCT02211261|OG004|Outcome|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
10966785|NCT00889187|OG001|Outcome|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
11203051|NCT02211261|OG000|Outcome|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203052|NCT02211261|OG000|Outcome|PF-06293620 50 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203053|NCT02211261|OG001|Outcome|PF-06293620 75 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203054|NCT02211261|OG002|Outcome|PF-06293620 150 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203055|NCT02211261|EG000|Reported Event|Placebo SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203056|NCT02211261|EG001|Reported Event|PF-06293620 0.3 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
10970613|NCT00911170|OG000|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11203057|NCT02211261|EG002|Reported Event|PF-06293620 1.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203058|NCT02211261|EG003|Reported Event|PF-06293620 3.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203059|NCT02211261|EG004|Reported Event|PF-06293620 6.0 mg/kg SC (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203060|NCT02211261|EG005|Reported Event|Placebo IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203061|NCT02211261|EG006|Reported Event|PF-06293620 1.0 mg/kg IV (SAD Cohorts)|One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
11203062|NCT02211261|EG007|Reported Event|Placebo SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203063|NCT02211261|EG008|Reported Event|PF-06293620 50 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
11203064|NCT02211261|EG009|Reported Event|PF-06293620 75 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
10804109|NCT04311177|OG001|Outcome|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
10804110|NCT04311177|EG000|Reported Event|Losartan|"Participants in this arm will receive the study drug, Losartan.~Losartan: Losartan; 25 mg daily; oral administration"
11243601|NCT02504502|OG001|Outcome|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
11203065|NCT02211261|EG010|Reported Event|PF-06293620 150 mg SC (MAD Cohorts)|One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
10804111|NCT04311177|EG001|Reported Event|Placebo|"Participants in this arm will receive a placebo treatment.~Placebo: Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration"
11203066|NCT02211313|BG000|Baseline|Ureteral Stent - Soft, 6 French|"Subjects randomized to soft stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11243602|NCT02504502|EG000|Reported Event|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
11203067|NCT02211313|BG001|Baseline|Ureteral Stent - Hydrophobic, 6 French|"Subjects randomized to hydrophobic stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11203068|NCT02211313|BG002|Baseline|Total|Total of all reporting groups
11203069|NCT02211313|FG000|Participant Flow|Ureteral Stent - Soft, 6 French|"Subjects randomized to soft stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
10970614|NCT00911170|OG001|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11203070|NCT02211313|FG001|Participant Flow|Ureteral Stent - Hydrophobic, 6 French|"Subjects randomized to hydrophobic stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
10970615|NCT00911170|EG000|Reported Event|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11203071|NCT02211313|OG000|Outcome|Ureteral Stent - Soft, 6 French|"Subjects randomized to soft stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11203072|NCT02211313|OG001|Outcome|Ureteral Stent - Hydrophobic, 6 French|"Subjects randomized to hydrophobic stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11203073|NCT02211313|EG000|Reported Event|Ureteral Stent - Soft, 6 French|"Subjects randomized to soft stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11243603|NCT02504502|EG001|Reported Event|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
10820452|NCT00058019|FG001|Participant Flow|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
11243604|NCT02504541|BG000|Baseline|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11203074|NCT02211313|EG001|Reported Event|Ureteral Stent - Hydrophobic, 6 French|"Subjects randomized to hydrophobic stent, size 6 French~Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1."
11203075|NCT02211456|BG000|Baseline|Participants|"Having an ablation procedure with access to the left side of the heart~Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max"
11092503|NCT01540266|EG003|Reported Event|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092504|NCT01540266|EG004|Reported Event|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11243605|NCT02504541|FG000|Participant Flow|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11243606|NCT02504541|OG000|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11092223|NCT01538199|BG000|Baseline|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
11243607|NCT02504541|EG000|Reported Event|Testosterone Enanthate Auto-injector|Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
11092224|NCT01538199|BG001|Baseline|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
11243608|NCT02504554|BG000|Baseline|Oral Group|"This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen administered orally: human fecal material; processed, frozen, administered orally"
11092225|NCT01538199|BG002|Baseline|Screen Fail/Not Randomized|9 participants screen failed (3 had HAM-D scores that were below the threshold for study inclusion, 2 had bipolar disorder, 1 had active substance abuse, 1 had an exclusionary comorbid medical disorder, 1 did not pass drug screen, 1 was not depressed) . 5 participants decided not to participate after the screen (1 due to time commitment, 2 were no longer interested, 1 was moving away, and 1 was lost to follow up). 1 was discontinued by investigator pre randomization at Visit 1 because it was discovered at Visit 1 that the patient's primary diagnosis was PTSD (MDD was secondary). Additionally, the patient's trauma symptoms significantly interfered with their ability to complete the study tasks.
11092226|NCT01538199|BG003|Baseline|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11092227|NCT01538199|BG004|Baseline|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11092228|NCT01538199|BG005|Baseline|Pilot Study Screen Fail/Not Randomized|"10 participants screen failed (5 had HAM-D scores that were above threshold for study inclusion criteria, 1 had too many failed trials in the current depressive episode, 1 had active substance abuse, 2 did not meet criteria for Major Depressive Disorder at the time of the screening visit, 1 had just started psychotherapy at the time of the screen). 1 participant dropped out pre-randomization due to time constraints.~(see protocol change 10/28/2014)"
11092229|NCT01538199|BG006|Baseline|Total|Total of all reporting groups
11092230|NCT01538199|FG000|Participant Flow|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
11092231|NCT01538199|FG001|Participant Flow|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
11092232|NCT01538199|FG002|Participant Flow|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11092233|NCT01538199|FG003|Participant Flow|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11092234|NCT01538199|OG000|Outcome|TLT Treatment Group 1 (Active TLT Treatment)|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
11092235|NCT01538199|OG001|Outcome|TLT Treatment Group 2 (Placebo)|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
11092236|NCT01538199|OG002|Outcome|TLT Treatment Group 1 (Active TLT Treatment) Completers|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks (completers only).~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
11092237|NCT01538199|OG003|Outcome|TLT Treatment Group 2 (Placebo) Completers|"The sham group will receive 2 treatments of the sham device per week for 8 weeks. This only includes those who were followed for the entire 8-week study period and who received a clinical assessment immediately after.~Sham device: The sham device does not emit near-infrared radiation."
11092238|NCT01538199|OG004|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~1 participant was missing a final visit 8 value, so LOCF was used for this value.~(see protocol change 10/28/2014)"
11092239|NCT01538199|OG002|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~1 participant was missing a final visit 8 value, so LOCF was used for this value.~(see protocol change 10/28/2014)"
11092240|NCT01538199|OG000|Outcome|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
11243609|NCT02504554|BG001|Baseline|Rectal Group|"This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen; administered orally and rectally: human fecal material; processed, frozen; administered orally and rectally"
11243610|NCT02504554|BG002|Baseline|Total|Total of all reporting groups
11092241|NCT01538199|OG001|Outcome|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
11092242|NCT01538199|OG002|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
10820453|NCT00058019|OG000|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
11092243|NCT01538199|OG003|Outcome|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11203076|NCT02211456|FG000|Participant Flow|Participants|"Having an ablation procedure with access to the left side of the heart~Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max~All patients underwent the pacing protocol"
10820454|NCT00058019|OG001|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
11203077|NCT02211456|OG000|Outcome|Participants|"Having an ablation procedure with access to the left side of the heart~Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max"
11203078|NCT02211456|EG000|Reported Event|Participants|"Having an ablation procedure with access to the left side of the heart~Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max"
11203079|NCT02211495|BG000|Baseline|No Device|Medical therapy
11203080|NCT02211495|BG001|Baseline|Device|As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.
11203081|NCT02211495|BG002|Baseline|Total|Total of all reporting groups
11203082|NCT02211495|FG000|Participant Flow|No Device|"Treated with best medical therapy~Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice"
11203083|NCT02211495|FG001|Participant Flow|Device|"As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.~GEKO device: Placed on the lateral aspect of the knee, when activated it causes the leg to twitch~Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice"
11203084|NCT02211495|OG000|Outcome|No Device|Medical therapy only.
11203085|NCT02211495|OG001|Outcome|Device|As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.
11203086|NCT02211495|OG000|Outcome|No Device (Week 0)|Medical therapy, no device.
11203087|NCT02211495|OG001|Outcome|No Device (Week 6)|Medical therapy, no device, week 6.
11203088|NCT02211495|OG002|Outcome|Device (Week 0)|"As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg.~Week 0"
11203089|NCT02211495|OG003|Outcome|Device (Week 6)|As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week, week 6.
11203090|NCT02211495|EG000|Reported Event|No Device|Medical therapy, no device.
11203091|NCT02211495|EG001|Reported Event|Device|As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.
11203092|NCT02211534|BG000|Baseline|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
11203093|NCT02211534|BG001|Baseline|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
11203094|NCT02211534|BG002|Baseline|Total|Total of all reporting groups
11203095|NCT02211534|FG000|Participant Flow|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
11203096|NCT02211534|FG001|Participant Flow|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
11203097|NCT02211534|OG000|Outcome|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
11203098|NCT02211534|OG001|Outcome|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
10820455|NCT00058019|EG000|Reported Event|Ixabeilone for Relapsed Aggressive NHL|
11215341|NCT02298803|OG000|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis. The MAGE results for each of the eight participants who experienced hypoglycemia are documented below.
11215342|NCT02298803|OG000|Outcome|Hypoglycemia Group|Those eight participants who experienced hypoglycemia (a Blood Glucose Level <3.5 mmol/L) for a minimum of 20 consecutive minutes during the nocturnal time period (2300-0700) are included in the Hypoglycemia Group for this analysis. The results for deltaQTc for each of the eight participants who experienced hypoglycemia are documented below.
11215343|NCT02298803|EG000|Reported Event|Hypoglycemic Group|N=9; these participants experienced at least one episode of hypoglycaemia (blood glucose level <3.5mmol/L) during the monitoring period.
11215344|NCT02298803|EG001|Reported Event|Normoglycemic Group|N=21; these participants experienced no episodes of hypoglycaemia during the monitoring period.
11215345|NCT02298842|BG000|Baseline|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
11215346|NCT02298842|BG001|Baseline|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
11215347|NCT02298842|BG002|Baseline|Total|Total of all reporting groups
11215348|NCT02298842|FG000|Participant Flow|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
11215349|NCT02298842|FG001|Participant Flow|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
11243611|NCT02504554|FG000|Participant Flow|Oral Group|"This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen administered orally: human fecal material; processed, frozen, administered orally"
11203099|NCT02211534|EG000|Reported Event|Pulsed Electromagnetic Field Device|"Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.~Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment."
11203100|NCT02211534|EG001|Reported Event|Sham Pulsed Electromagnetic Field Device|"Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.~Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device."
11203101|NCT02211638|BG000|Baseline|Candesartan Cilexetil 4 mg to 8 mg|Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care.
11203102|NCT02211638|FG000|Participant Flow|Candesartan Cilexetil 4 mg to 8 mg|Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care.
11203103|NCT02211638|OG000|Outcome|Candesartan Cilexetil 4 mg to 8 mg|Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care.
11203104|NCT02211638|EG000|Reported Event|Candesartan Cilexetil 4 mg to 8 mg|Candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary. Participants received interventions as part of routine medical care.
11203105|NCT02212028|BG000|Baseline|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
10847459|NCT00283387|FG000|Participant Flow|Betaine First, Then Placebo|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old) divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral lactose placebo divided in two doses daily, for 2 months.
11203106|NCT02212028|BG001|Baseline|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
11203107|NCT02212028|BG002|Baseline|Total|Total of all reporting groups
11092244|NCT01538199|OG004|Outcome|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
10847460|NCT00283387|FG001|Participant Flow|Placebo First, Then Betaine|Subjects received oral lactose placebo divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
11203108|NCT02212028|FG000|Participant Flow|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
11203109|NCT02212028|FG001|Participant Flow|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
11203110|NCT02212028|OG000|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
11203111|NCT02212028|OG001|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
11203112|NCT02212028|EG000|Reported Event|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
11203113|NCT02212028|EG001|Reported Event|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
11203114|NCT02212106|BG000|Baseline|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203115|NCT02212106|BG001|Baseline|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203116|NCT02212106|BG002|Baseline|Total|Total of all reporting groups
11243612|NCT02504554|FG001|Participant Flow|Rectal Group|"This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen; administered orally and rectally: human fecal material; processed, frozen; administered orally and rectally"
10847461|NCT00283387|OG000|Outcome|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
10847462|NCT00283387|OG001|Outcome|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
11243613|NCT02504554|OG000|Outcome|Combined Group|Combination of both groups
11203117|NCT02212106|FG000|Participant Flow|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203118|NCT02212106|FG001|Participant Flow|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203119|NCT02212106|OG000|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203120|NCT02212106|OG000|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203121|NCT02212106|OG001|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203122|NCT02212106|EG000|Reported Event|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203123|NCT02212106|EG001|Reported Event|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
11203124|NCT02212197|BG000|Baseline|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
11203125|NCT02212197|BG001|Baseline|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
11203126|NCT02212197|BG002|Baseline|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
11203127|NCT02212197|BG003|Baseline|Total|Total of all reporting groups
11203128|NCT02212197|FG000|Participant Flow|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
11203129|NCT02212197|FG001|Participant Flow|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
11203130|NCT02212197|FG002|Participant Flow|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
11203131|NCT02212197|OG000|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
11203132|NCT02212197|OG001|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
11203133|NCT02212197|OG002|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
11203134|NCT02212197|EG000|Reported Event|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
11203135|NCT02212197|EG001|Reported Event|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
11203136|NCT02212197|EG002|Reported Event|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
11203137|NCT02212301|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one lens throughout the duration of the study.
11203138|NCT02212301|FG000|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.
11203139|NCT02212301|FG001|Participant Flow|Lotrafilcon B / Senofilcon A|Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
11203140|NCT02212301|OG000|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
11203141|NCT02212301|OG001|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B in either the first or second period of the study.
11203142|NCT02212301|OG001|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
11203143|NCT02212301|EG000|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
11203144|NCT02212301|EG001|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
11203145|NCT02212379|BG000|Baseline|Raltegravir and Etravirine|"raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.~Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal."
11203146|NCT02212379|FG000|Participant Flow|Raltegravir and Etravirine|"raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.~Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal."
11203147|NCT02212379|OG000|Outcome|Raltegravir and Etravirine|"raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.~Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal."
11203148|NCT02212379|OG000|Outcome|Premenopausal With Mesurable AMH|AMH was detectable (level >0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity
10847463|NCT00283387|EG000|Reported Event|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
11203149|NCT02212379|OG001|Outcome|Premenopausal With Reduced Ovarian Reserve|AMH<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
11203150|NCT02212379|OG002|Outcome|Postmenopausal|The menopausal status was recorded by the questionnaire at inclusion
11203151|NCT02212379|EG000|Reported Event|Raltegravir and Etravirine|"raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.~Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal."
11203152|NCT02212457|BG000|Baseline|rMenB_0_2 Group|Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203153|NCT02212457|BG001|Baseline|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203154|NCT02212457|BG002|Baseline|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
11203155|NCT02212457|BG003|Baseline|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
11203156|NCT02212457|BG004|Baseline|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
10847464|NCT00283387|EG001|Reported Event|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
11203157|NCT02212457|BG005|Baseline|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
11203158|NCT02212457|BG006|Baseline|Total|Total of all reporting groups
11203159|NCT02212457|FG000|Participant Flow|rMenB_0_2 Group|Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
10847465|NCT00283400|BG000|Baseline|Dosage Tier 1|25% human albumin 0.625 g/kg
10847466|NCT00283400|BG001|Baseline|Dosage Tier 2|25% human albumin 1.25 g/kg
10847467|NCT00283400|BG002|Baseline|Dosage Tier 3|25% human albumin 1.875 g/kg
10847468|NCT00283400|BG003|Baseline|Dosage Tier 4|25% human albumin 2.5 g/kg
11203160|NCT02212457|FG001|Participant Flow|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203161|NCT02212457|FG002|Participant Flow|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
11203162|NCT02212457|FG003|Participant Flow|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
11203163|NCT02212457|FG004|Participant Flow|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
10847469|NCT00283400|BG004|Baseline|Total|Total of all reporting groups
10847470|NCT00283400|FG000|Participant Flow|Dosage Tier 1|25% human albumin 0.625 g/kg
10847471|NCT00283400|FG001|Participant Flow|Dosage Tier 2|25% human albumin 1.25 g/kg
10847472|NCT00283400|FG002|Participant Flow|Dosage Tier 3|25% human albumin 1.875 g/kg
10847473|NCT00283400|FG003|Participant Flow|Dosage Tier 4|25% human albumin2.5 g/kg
11203164|NCT02212457|FG005|Participant Flow|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
11203165|NCT02212457|OG000|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203166|NCT02212457|OG001|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203167|NCT02212457|OG001|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
11203168|NCT02212457|OG001|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
11203169|NCT02212457|OG002|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
10847474|NCT00283400|OG000|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
11203170|NCT02212457|OG003|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
11203171|NCT02212457|OG000|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203172|NCT02212457|OG001|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
10847475|NCT00283400|OG001|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
10847476|NCT00283400|OG002|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
10847477|NCT00283400|OG003|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
10847478|NCT00283400|EG000|Reported Event|Dosage Tier 1|25% human albumin 0.625 g/kg
11203173|NCT02212457|OG000|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
11203174|NCT02212457|OG002|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
11203175|NCT02212457|OG003|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
11203176|NCT02212457|OG004|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
11203177|NCT02212457|OG005|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
10847479|NCT00283400|EG001|Reported Event|Dosage Tier 2|25% human albumin 1.25 g/kg
11203178|NCT02212457|EG000|Reported Event|rMenB_0_2 Group|Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203179|NCT02212457|EG001|Reported Event|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
11203180|NCT02212457|EG002|Reported Event|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
10847480|NCT00283400|EG002|Reported Event|Dosage Tier 3|25% human albumin 1.875 g/kg
10847481|NCT00283400|EG003|Reported Event|Dosage Tier 4|25% human albumin 2.5 g/kg
10847482|NCT00283439|BG000|Baseline|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
11203181|NCT02212457|EG003|Reported Event|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
10804112|NCT04241133|BG000|Baseline|Experimental Group|A 12 week pilot trial was conducted at two rural food pantries in Montana with low-income adults to measure within-participant changes over time. The UnProcessed Pantry Project (UP3): UP3 used the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). It was hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which would improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group.
10804113|NCT04241133|BG001|Baseline|Control Group|Participants from a different food pantry were be enrolled into a control group with no intervention.
10804114|NCT04241133|BG002|Baseline|Total|Total of all reporting groups
10804115|NCT04241133|FG000|Participant Flow|Experimental Group|For a 12 week pilot trial, 44 adults enrolled in the UP3 intervention and within-participant changes were measured over time. The UnProcessed Pantry Project (UP3): UP3 uses the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). It was hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which will improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group.
10804116|NCT04241133|FG001|Participant Flow|Control Group|34 participants enrolled from a different food pantry were enrolled into a control group. The post assessment was cancelled due to COVID-19 precautions.
10847483|NCT00283439|BG001|Baseline|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
10847484|NCT00283439|BG002|Baseline|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
11203182|NCT02212457|EG004|Reported Event|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
11203183|NCT02212457|EG005|Reported Event|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
10847485|NCT00283439|BG003|Baseline|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
11203184|NCT02212587|BG000|Baseline|TOBI Podhaler|TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
11203185|NCT02212587|FG000|Participant Flow|TOBI Podhaler|TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
11203186|NCT02212587|OG000|Outcome|TOBI Podhaler|TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
10847486|NCT00283439|BG004|Baseline|Total|Total of all reporting groups
11203187|NCT02212587|EG000|Reported Event|TOBI Podhaler|TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
10966786|NCT00889187|OG002|Outcome|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966787|NCT00889187|OG000|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966788|NCT00889187|EG000|Reported Event|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10847487|NCT00283439|FG000|Participant Flow|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
11203188|NCT02212678|BG000|Baseline|N-acetylcysteine|"Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days~N-acetylcysteine capsule: N-acetylcysteine capsule"
10847488|NCT00283439|FG001|Participant Flow|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
10847489|NCT00283439|FG002|Participant Flow|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
11203189|NCT02212678|FG000|Participant Flow|N-acetylcysteine|"Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days~N-acetylcysteine capsule: N-acetylcysteine capsule"
11203190|NCT02212678|OG000|Outcome|N-acetylcysteine|"Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days~N-acetylcysteine capsule: N-acetylcysteine capsule"
10822113|NCT00074490|OG003|Outcome|Arm IVB (6-day Expanded Th2 DLI)|Arm IVB Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11203191|NCT02212678|EG000|Reported Event|N-acetylcysteine|"Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days~N-acetylcysteine capsule: N-acetylcysteine capsule"
11203192|NCT02212730|BG000|Baseline|Neoadjuvant Pembrolizumab + RCC Resection|Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
11203193|NCT02212730|BG001|Baseline|RCC Resection|Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
11203194|NCT02212730|BG002|Baseline|Total|Total of all reporting groups
11203195|NCT02212730|FG000|Participant Flow|Neoadjuvant Pembrolizumab + RCC Resection|Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
11203196|NCT02212730|FG001|Participant Flow|RCC Resection|Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
11203197|NCT02212730|OG000|Outcome|Neoadjuvant Pembrolizumab + RCC Resection|Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
11203198|NCT02212730|OG001|Outcome|RCC Resection|Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
11203199|NCT02212730|EG000|Reported Event|Neoadjuvant Pembrolizumab + RCC Resection|Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab.
11203200|NCT02212730|EG001|Reported Event|Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab|Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab.
11203201|NCT02212730|EG002|Reported Event|SOC RCC Resection|Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab.
11203202|NCT02212730|EG003|Reported Event|RCC Resection + Post-Resection Pembrolizumab|Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab.
10847490|NCT00283439|FG003|Participant Flow|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
11203203|NCT02212834|BG000|Baseline|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
11203204|NCT02212834|BG001|Baseline|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
11203205|NCT02212834|BG002|Baseline|Total|Total of all reporting groups
11203206|NCT02212834|FG000|Participant Flow|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
11203207|NCT02212834|FG001|Participant Flow|Breast MRI|Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
11203208|NCT02212834|OG000|Outcome|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
11203209|NCT02212834|OG001|Outcome|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
11203210|NCT02212834|EG000|Reported Event|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
11203211|NCT02212834|EG001|Reported Event|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
11203212|NCT02212977|BG000|Baseline|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
11203213|NCT02212977|BG001|Baseline|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
11203214|NCT02212977|BG002|Baseline|Total|Total of all reporting groups
11203215|NCT02212977|FG000|Participant Flow|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
10847491|NCT00283439|OG000|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
10847492|NCT00283439|OG001|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
10804117|NCT04241133|OG000|Outcome|Experimental Group|A 12 week pilot trial will be conducted at two rural food pantries in Montana with low-income adults to measure within-participant changes over time. The study will provide the initial investigation of the extent to which UP3 will improve overall dietary quality as measured by the Healthy Eating Index-2015 (HEI) compared to baseline. It is hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which will improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group.
10804118|NCT04241133|OG001|Outcome|Control Group|Participants from a different food pantry will be enrolled into a control group. The primary outcome measure will be dietary intake. No intervention will be applied.
10822114|NCT00074490|EG000|Reported Event|Arm IVD Cohort 1 (Th2 DLI)|Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
11203216|NCT02212977|FG001|Participant Flow|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
11203217|NCT02212977|OG000|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
11203218|NCT02212977|OG001|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
11203219|NCT02212977|EG000|Reported Event|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
11203220|NCT02212977|EG001|Reported Event|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
11203221|NCT02213042|BG000|Baseline|LAP+TRAS±AI (HER2-Enriched) - Arm A|Lapatinib 1000mg + Trastuzumab in HER2 Enriched In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11243614|NCT02504554|OG000|Outcome|Oral Group|"This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen administered orally: human fecal material; processed, frozen, administered orally"
10847493|NCT00283439|OG002|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
10966789|NCT00889187|EG001|Reported Event|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966790|NCT00889187|EG002|Reported Event|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
10966791|NCT00889200|BG000|Baseline|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
10966792|NCT00889200|FG000|Participant Flow|Open-label Eszopiclone|"Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
10966793|NCT00889200|OG000|Outcome|Open-label Eszopiclone|After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
10966794|NCT00889200|EG000|Reported Event|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
10966795|NCT00889226|BG000|Baseline|Pitavastatin Group|Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
10966796|NCT00889226|BG001|Baseline|Atorvastatin Group|Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
10966797|NCT00889226|BG002|Baseline|Total|Total of all reporting groups
10966798|NCT00889226|FG000|Participant Flow|Pitavastatin Group|Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
10966799|NCT00889226|FG001|Participant Flow|Atorvastatin Group|Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
10966800|NCT00889226|OG000|Outcome|Pitavastatin Group|Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
10966801|NCT00889226|OG001|Outcome|Atorvastatin Group|Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
10966802|NCT00889226|EG000|Reported Event|Pitavastatin Group|Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
10966803|NCT00889226|EG001|Reported Event|Atorvastatin Group|Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
10966804|NCT00889252|BG000|Baseline|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
10966805|NCT00889252|BG001|Baseline|Placebo Lens|contact lens without drug
10966806|NCT00889252|BG002|Baseline|Total|Total of all reporting groups
10966807|NCT00889252|FG000|Participant Flow|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
10966808|NCT00889252|FG001|Participant Flow|Placebo Lens|contact lens without drug
10966809|NCT00889252|OG000|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
10966810|NCT00889252|OG001|Outcome|Placebo Lens|contact lens without drug
10966811|NCT00889252|EG000|Reported Event|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
10966812|NCT00889252|EG001|Reported Event|Placebo Lens|contact lens without drug
10966813|NCT00889265|BG000|Baseline|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
10966814|NCT00889265|FG000|Participant Flow|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
10966815|NCT00889265|OG000|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
10970616|NCT00911170|EG001|Reported Event|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11243615|NCT02504554|OG001|Outcome|Rectal Group|"This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.~oral Vancomycin: an antibiotic~MoviPrep: a bowel cleanse~Prilosec: a stomach acid suppressan~human fecal material; processed, frozen; administered orally and rectally: human fecal material; processed, frozen; administered orally and rectally"
10847494|NCT00283439|OG003|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
10847495|NCT00283439|EG000|Reported Event|Romiplostim 100 µg|
10847496|NCT00283439|EG001|Reported Event|Romiplostim 300 µg|
10847497|NCT00283439|EG002|Reported Event|Romiplostim 700 µg|
10847498|NCT00283439|EG003|Reported Event|Romiplostim 1000 µg|
10847499|NCT00283504|BG000|Baseline|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
10847500|NCT00283504|BG001|Baseline|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
10847501|NCT00283504|BG002|Baseline|Total|Total of all reporting groups
10847502|NCT00283504|FG000|Participant Flow|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
10847503|NCT00283504|FG001|Participant Flow|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
10822115|NCT00074490|EG001|Reported Event|Arm IVD Cohort 3 (Multiple Th2 DLI)|Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
10847504|NCT00283504|OG000|Outcome|Eosinophilic Phenotype|participants received xolair per standard practice
10847505|NCT00283504|OG001|Outcome|Non Eosinophilic Phenotype|participants received xolair per standard practice
10847506|NCT00283504|OG000|Outcome|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
11203222|NCT02213042|BG001|Baseline|TRAS+CHEM±AI (HER2-Enriched) - Arm B|Trastuzumab in HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Trastuzumab (loading dose of 8 mg/kg followed by the maintenance dose of 6 mg/kg IV q3weekly) along with chemotherapy of the investigator's choice or Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly along with chemotherapy of the investigators choice. Subjects randomized to this arm and hormone receptor positive received an aromatase inhibitor at the discretion of the investigator.
11203223|NCT02213042|BG002|Baseline|Non-HER2- Enriched - Arm C|Lapatinib 1000mg + Trastuzumab in Non- HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of Non- HER2 Enriched (luminal A, luminal B or Basal type), Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203224|NCT02213042|BG003|Baseline|Total|Total of all reporting groups
11203225|NCT02213042|FG000|Participant Flow|LAP+TRAS±AI (HER2-Enriched) - Arm A|Lapatinib 1000mg + Trastuzumab in HER2 Enriched In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203226|NCT02213042|FG001|Participant Flow|TRAS+CHEM±AI (HER2-Enriched) - Arm B|Trastuzumab in HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Trastuzumab (loading dose of 8 mg/kg followed by the maintenance dose of 6 mg/kg IV q3weekly) along with chemotherapy of the investigator's choice or Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly along with chemotherapy of the investigators choice. Subjects randomized to this arm and hormone receptor positive received an aromatase inhibitor at the discretion of the investigator.
11203227|NCT02213042|FG002|Participant Flow|Non-HER2- Enriched - Arm C|Lapatinib 1000mg + Trastuzumab in Non- HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of Non- HER2 Enriched (luminal A, luminal B or Basal type), Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203228|NCT02213042|OG000|Outcome|LAP+TRAS±AI (HER2-Enriched) - Arm A|Lapatinib 1000mg + Trastuzumab in HER2 Enriched In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203229|NCT02213042|OG000|Outcome|TRAS+CHEM±AI (HER2-Enriched) - Arm B|Trastuzumab in HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Trastuzumab (loading dose of 8 mg/kg followed by the maintenance dose of 6 mg/kg IV q3weekly) along with chemotherapy of the investigator's choice or Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly along with chemotherapy of the investigators choice. Subjects randomized to this arm and hormone receptor positive received an aromatase inhibitor at the discretion of the investigator.
11203230|NCT02213042|OG000|Outcome|Non-HER2- Enriched - Arm C|Lapatinib 1000mg + Trastuzumab in Non- HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of Non- HER2 Enriched (luminal A, luminal B or Basal type), Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203231|NCT02213042|OG001|Outcome|TRAS+CHEM±AI (HER2-Enriched) - Arm B|Trastuzumab in HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Trastuzumab (loading dose of 8 mg/kg followed by the maintenance dose of 6 mg/kg IV q3weekly) along with chemotherapy of the investigator's choice or Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly along with chemotherapy of the investigators choice. Subjects randomized to this arm and hormone receptor positive received an aromatase inhibitor at the discretion of the investigator.
11203232|NCT02213042|OG002|Outcome|Non-HER2- Enriched - Arm C|Lapatinib 1000mg + Trastuzumab in Non- HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of Non- HER2 Enriched (luminal A, luminal B or Basal type), Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203233|NCT02213042|EG000|Reported Event|LAP+TRAS±AI (HER2-Enriched) - Arm A|Lapatinib 1000mg + Trastuzumab in HER2 Enriched In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
10847507|NCT00283504|OG001|Outcome|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
11203234|NCT02213042|EG001|Reported Event|TRAS+CHEM±AI (HER2-Enriched) • ArmB|Trastuzumab in HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of HER2 Enriched, Trastuzumab (loading dose of 8 mg/kg followed by the maintenance dose of 6 mg/kg IV q3weekly) along with chemotherapy of the investigator's choice or Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly along with chemotherapy of the investigators choice. Subjects randomized to this arm and hormone receptor positive received an aromatase inhibitor at the discretion of the investigator.
11286127|NCT02883452|EG005|Reported Event|Arm 2: CT-P13 IV 5 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV were switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
10847508|NCT00283504|EG000|Reported Event|Eosinophilic Phenotype|participants received xolair per standard practice
11203235|NCT02213042|EG002|Reported Event|Non-HER2-Enriched - Arm C|Lapatinib 1000mg + Trastuzumab in Non- HER2 Enriched: In subjects with HER2-overexpressing MBC with a molecular subtype of Non- HER2 Enriched (luminal A, luminal B or Basal type), Lapatinib 1000mg once daily orally along with Trastuzumab (loading dose of 8 milligram/ kilogram (mg/kg) followed by the maintenance dose of 6 mg/kg Intravenous (IV) Every 3 weeks (q3weekly)) or Lapatinib 1000 milligram (mg) once daily orally along with Weekly Trastuzumab (loading dose of 4 mg/kg) followed by maintenance dose of 2 mg/kg IV weekly. For subjects who were hormone receptor positive, an aromatase inhibitor of the investigator's choice was required.
11203236|NCT02213055|BG000|Baseline|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
11203237|NCT02213055|BG001|Baseline|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application."
11203238|NCT02213055|BG002|Baseline|Total|Total of all reporting groups
11203239|NCT02213055|FG000|Participant Flow|LICEMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
11203240|NCT02213055|FG001|Participant Flow|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
11203241|NCT02213055|OG000|Outcome|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
11203242|NCT02213055|OG001|Outcome|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application."
11203243|NCT02213055|EG000|Reported Event|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
11286128|NCT02884089|BG000|Baseline|Overall Study|Single oral dose of placebo or 400 mg Abemaciclib is administered along with 1000 mg Metformin orally or 5 mL (3235 mg) Iohexol by IV infusion on day 1 as per the dosing schedule in each period.
11203244|NCT02213055|EG001|Reported Event|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
11203245|NCT02213068|BG000|Baseline|Belatacept + MPA|"subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:~Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue~MPA: administered according to SOC~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203246|NCT02213068|BG001|Baseline|Belatacept + Low-Dose Tac|"Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention"
11203247|NCT02213068|BG002|Baseline|Tacrolimus + MPA Standard Treatment Regimen|"Standard of Care treatment regimen:~Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.~MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.~MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203248|NCT02213068|BG003|Baseline|Total|Total of all reporting groups
11203249|NCT02213068|FG000|Participant Flow|Belatacept + MPA|"subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:~Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue~MPA: administered according to SOC~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203250|NCT02213068|FG001|Participant Flow|Belatacept + Low-Dose Tac|"Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention"
11203251|NCT02213068|FG002|Participant Flow|Tacrolimus + MPA Standard Treatment Regimen|"Standard of Care treatment regimen:~Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.~MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.~MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203252|NCT02213068|OG000|Outcome|Belatacept + MPA|"subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:~Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue~MPA: administered according to SOC~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
10847509|NCT00283504|EG001|Reported Event|Non Eosinophilic Phenotype|participants received xolair per standard practice
11203253|NCT02213068|OG001|Outcome|Belatacept + Low-Dose Tac|"Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention"
11203254|NCT02213068|OG002|Outcome|Tacrolimus + MPA Standard Treatment Regimen|"Standard of Care treatment regimen:~Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.~MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.~MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203255|NCT02213068|EG000|Reported Event|Belatacept + MPA|"subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:~Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue~MPA: administered according to SOC~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203256|NCT02213068|EG001|Reported Event|Belatacept + Low-Dose Tac|"Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.~Tacrolimus tapered over one month as follows:~Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter.~belatacept: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention"
10847510|NCT00283595|BG000|Baseline|Recombinant Human Growth Hormone Group|Treatment with rHGH
10847511|NCT00283595|BG001|Baseline|Placebo Group|Treatment with Placebo
10847512|NCT00283595|BG002|Baseline|Total|Total of all reporting groups
11203257|NCT02213068|EG002|Reported Event|Tacrolimus + MPA Standard Treatment Regimen|"Standard of Care treatment regimen:~Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.~MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.~MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator.~Tacrolimus: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention~MPA: Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention"
11203258|NCT02213094|BG000|Baseline|Nicotinamide 500 mg|Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203259|NCT02213094|BG001|Baseline|Nicotinamide 1000 mg|Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203260|NCT02213094|BG002|Baseline|Total|Total of all reporting groups
11203261|NCT02213094|FG000|Participant Flow|Nicotinamide 500 mg|Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203262|NCT02213094|FG001|Participant Flow|Nicotinamide 1000 mg|Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203263|NCT02213094|OG000|Outcome|Nicotinamide 500 mg|Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203264|NCT02213094|OG001|Outcome|Nicotinamide 1000 mg|Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203265|NCT02213094|EG000|Reported Event|Nicotinamide 500 mg|Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
10847513|NCT00283595|FG000|Participant Flow|Recombinant Human Growth Hormone(Subcutaneous Daily Injection)|Treatment with rHGH
11203266|NCT02213094|EG001|Reported Event|Nicotinamide 1000 mg|Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
11203267|NCT02213133|BG000|Baseline|Cohort 1: Head and Neck-SCC|Participants with advanced SCC of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203268|NCT02213133|BG001|Baseline|Cohort 2: Lungs-SCC|Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203269|NCT02213133|BG002|Baseline|Cohort 3: Esophagus-SCC|Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203270|NCT02213133|BG003|Baseline|Total|Total of all reporting groups
11203271|NCT02213133|FG000|Participant Flow|Cohort 1: Head and Neck-SCC|Participants with advanced squamous cell carcinoma (SCC) of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 milligrams (mg) selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets less than [<] 100*10^9 per litre [/L]), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203272|NCT02213133|FG001|Participant Flow|Cohort 2: Lungs-SCC|Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203273|NCT02213133|FG002|Participant Flow|Cohort 3: Esophagus-SCC|Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11286129|NCT02884089|FG000|Participant Flow|Sequence 1|Single oral dose of 400 milligram (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 milliliter (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1 : Placebo + Metformin;Period 2: Abemaciclib + Metformin;Period 3: Placebo + Iohexol;Period 4: Abemaciclib + Iohexol).
11203274|NCT02213133|OG000|Outcome|Cohort 1: Head and Neck-SCC|Participants with advanced SCC of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203275|NCT02213133|OG001|Outcome|Cohort 2: Lungs-SCC|Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203276|NCT02213133|OG002|Outcome|Cohort 3: Esophagus-SCC|Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203277|NCT02213133|OG001|Outcome|Cohort 2: Lungs-SCC|Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
10847514|NCT00283595|FG001|Participant Flow|Placebo (Subcutaneous Daily Injection)|Treatment with Placebo
10847515|NCT00283595|OG000|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
10847516|NCT00283595|OG001|Outcome|Placebo Group|Treatment with Placebo
11092505|NCT01540266|EG005|Reported Event|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11092506|NCT01540370|BG000|Baseline|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
11092507|NCT01540370|FG000|Participant Flow|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
11092508|NCT01540370|OG000|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
10847517|NCT00283595|EG000|Reported Event|Recombinant Human Growth Hormone Group|Treatment with rHGH
10847518|NCT00283595|EG001|Reported Event|Placebo Group|Treatment with Placebo
11092509|NCT01540370|EG000|Reported Event|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
11203278|NCT02213133|EG000|Reported Event|Cohort 1: Head and Neck-SCC|Participants with advanced SCC of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203279|NCT02213133|EG001|Reported Event|Cohort 2: Lungs-SCC|Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11243616|NCT02504554|EG000|Reported Event|All Groups|We report the data on 18 participants, regardless of how the initial dose of bacteria was administered. The reason is that all but one of the adverse events occurred during the vancomycin phase, which was common to both groups, and occurred before the randomization to receive the microbiota either orally or rectally. The only exception is one participant who had initial nausea/vomiting upon receiving the initial oral dose of microbiota, and they were switched from the oral group to the rectal group, which they tolerated without incident. There were no adverse effects from the microbiota.
11243617|NCT02504619|BG000|Baseline|CordIn|"Transplantation of CordIn~CordIn: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells."
11243618|NCT02504619|FG000|Participant Flow|CordIn|"Transplantation of CordIn~CordIn: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells."
11243619|NCT02504619|OG000|Outcome|CordIn|"Transplantation of CordIn~CordIn: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells."
11243620|NCT02504619|OG000|Outcome|CordIn|Transplantation of CordIn CordIn: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.
11243621|NCT02504619|EG000|Reported Event|CordIn|"Transplantation of CordIn~CordIn: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells."
11243622|NCT02504645|BG000|Baseline|IPP-201101 200-mcg Plus SOC|"Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~IPP-201101~Standard of Care"
11243623|NCT02504645|BG001|Baseline|PLACEBO Plus SOC|"Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~Placebo~Standard of Care"
11243624|NCT02504645|BG002|Baseline|Total|Total of all reporting groups
11243625|NCT02504645|FG000|Participant Flow|IPP-201101 200-mcg Plus SOC|"Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~IPP-201101~Standard of Care"
11243626|NCT02504645|FG001|Participant Flow|PLACEBO Plus SOC|"Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~Placebo~Standard of Care"
11243627|NCT02504645|OG000|Outcome|IPP-201101 200-mcg Plus SOC|"Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~IPP-201101~Standard of Care"
11243628|NCT02504645|OG001|Outcome|PLACEBO Plus SOC|"Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~Placebo~Standard of Care"
11243629|NCT02504645|EG000|Reported Event|IPP-201101 200-mcg Plus SOC|"Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~IPP-201101~Standard of Care"
11243630|NCT02504645|EG001|Reported Event|PLACEBO Plus SOC|"Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).~Placebo~Standard of Care"
11243631|NCT02504671|BG000|Baseline|Placebo|Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243632|NCT02504671|BG001|Baseline|GSK3196165 22.5 mg|Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243633|NCT02504671|BG002|Baseline|GSK3196165 45 mg|Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243634|NCT02504671|BG003|Baseline|GSK3196165 90 mg|Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11203280|NCT02213133|EG002|Reported Event|Esophagus-SCC|Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
11203281|NCT02213198|BG000|Baseline|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
11203282|NCT02213198|BG001|Baseline|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
11203283|NCT02213198|BG002|Baseline|Total|Total of all reporting groups
11203284|NCT02213198|FG000|Participant Flow|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
11203285|NCT02213198|FG001|Participant Flow|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
11203286|NCT02213198|OG000|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
11203287|NCT02213198|OG001|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
11203288|NCT02213198|EG000|Reported Event|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
11203289|NCT02213198|EG001|Reported Event|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
11203290|NCT02213250|BG000|Baseline|All Participants|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203291|NCT02213250|FG000|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203292|NCT02213250|FG001|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203293|NCT02213250|OG000|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203294|NCT02213250|OG001|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203295|NCT02213250|OG000|Outcome|BeneFIX 50 IU/kg; Age Group>=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203296|NCT02213250|OG000|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
11203297|NCT02213250|EG000|Reported Event|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
10804119|NCT04241133|EG000|Reported Event|Experimental Group|A 12 week pilot trial was conducted at two rural food pantries in Montana with low-income adults to measure within-participant changes over time. The UnProcessed Pantry Project (UP3): UP3 used the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). It was hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which would improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group.
11203298|NCT02213263|BG000|Baseline|Rituximab-EU|Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203299|NCT02213263|BG001|Baseline|PF-05280586|Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203300|NCT02213263|BG002|Baseline|Total|Total of all reporting groups
11203301|NCT02213263|FG000|Participant Flow|Rituximab-EU|Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203302|NCT02213263|FG001|Participant Flow|PF-05280586|Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
10804120|NCT04241133|EG001|Reported Event|Control Group|Participants from a different food pantry were be enrolled into a control group with no intervention. The Healthy Eating Index-2015 was the primary outcome measure.
11203303|NCT02213263|OG000|Outcome|Rituximab-EU|Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203304|NCT02213263|OG001|Outcome|PF-05280586|Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203305|NCT02213263|EG000|Reported Event|Rituximab-EU|Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203306|NCT02213263|EG001|Reported Event|PF-05280586|Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
11203307|NCT02213289|BG000|Baseline|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive patients received standard cytoptherapy plus Nivolumab~HER2 amplified patients received standard cytotherapy plus Trastuzumab~EGFR amplified patients received standard cytotherapy plus ABT-806~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203308|NCT02213289|BG001|Baseline|Non-ITT: Standard Therapy|For patients without monoclonal antibodies available, therapy was standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
11203309|NCT02213289|BG002|Baseline|Total|Total of all reporting groups
11203310|NCT02213289|FG000|Participant Flow|ITT-PTS: Personalized Treatment Strategy|"For patients with monoclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus Trastuzumab.~EGFR amplified patients received standard cytotherapy plus ABT-806~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab.~Of note, while the protocol section describes these tailored therapies, the efficacy evaluation was based on pooling these treatments into a combined personalized treatment strategy group and comparing with historical controls. Therefore this arm includes all such patients with monoclonal antibodies available."
11203311|NCT02213289|FG001|Participant Flow|Non-ITT: Standard Therapy|"For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)~Of note, this arm includes patients without monoclonal antibodies available, for whom no personalized treatment strategy was available. The intent of the protocol was NOT to compare this arm with arm 1."
11203312|NCT02213289|OG000|Outcome|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus received Trastuzumab~EGFR amplified patients received standard cytotherapy plus ABT-806~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203313|NCT02213289|OG001|Outcome|Non-ITT: Standard Therapy|For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
11203314|NCT02213289|OG000|Outcome|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patient including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus received Trastuzumab~EGFR amplified patients received standard cytotherapy plus ABT-806.~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11286130|NCT02884089|FG001|Participant Flow|Sequence 2|Single oral dose of 400 (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Abemaciclib + Metformin;Period 2: Placebo + Metformin;Period 3: Abemaciclib + Iohexol;Period 4: Placebo + Iohexol).
10804121|NCT04190693|BG000|Baseline|Cohort 1|Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27
10804122|NCT04190693|BG001|Baseline|Cohort 2|Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27
10804123|NCT04190693|BG002|Baseline|Cohort 3|Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27
10804124|NCT04190693|BG003|Baseline|Placebo|Patients having received Placebo in study 2016-003514-27
10804125|NCT04190693|BG004|Baseline|Total|Total of all reporting groups
11203315|NCT02213289|OG000|Outcome|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus received Trastuzumab~EGFR amplified patients received standard cytotherapy plus ABT-806~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plous ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203316|NCT02213289|OG000|Outcome|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus Trastuzumab~EGFR amplified patients received standard cytotherapy plus ABT-806~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203317|NCT02213289|OG000|Outcome|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus Trastuzumab.~EGFR amplified patients received standard cytotherapy plus ABT-806.~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203318|NCT02213289|EG000|Reported Event|ITT-PTS: Personalized Treatment Strategy|"For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:~Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.~HER2 amplified patients received standard cytotherapy plus Trastuzumab.~EGFR amplified patients received standard cytotherapy plus ABT-806..~FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.~MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.~EGFR expressing patients received standard cytotherapy plus ABT 806.~All negative patients received standard cytotherapy plus Ramucirumab."
11203319|NCT02213289|EG001|Reported Event|Non-ITT: Standard Therapy|For patients without monoclonal antibodies available.These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
11203320|NCT02213458|BG000|Baseline|Navigated Care|"Comprehensive longitudinal continuing care program~Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs)."
11203321|NCT02213458|BG001|Baseline|Survey of Care|Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
11203322|NCT02213458|BG002|Baseline|Total|Total of all reporting groups
11203323|NCT02213458|FG000|Participant Flow|Navigated Care|"Comprehensive longitudinal continuing care program~Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs)."
11203324|NCT02213458|FG001|Participant Flow|Survey of Care|Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
11203325|NCT02213458|OG000|Outcome|Navigated Care|"Comprehensive longitudinal continuing care program~Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs)."
11203326|NCT02213458|OG001|Outcome|Survey of Care|Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
11203327|NCT02213458|EG000|Reported Event|Navigated Care|"Comprehensive longitudinal continuing care program~Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs)."
11203328|NCT02213458|EG001|Reported Event|Survey of Care|Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
11286131|NCT02884089|FG002|Participant Flow|Sequence 3|Single oral dose of 400 (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Placebo + Iohexol;Period 2: Abemaciclib + Iohexol;Period 3: Placebo + Metformin;Period 4: Abemaciclib + Metformin).
10966816|NCT00889265|EG000|Reported Event|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
11203329|NCT02213510|BG000|Baseline|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
11203330|NCT02213510|BG001|Baseline|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
11203331|NCT02213510|BG002|Baseline|Total|Total of all reporting groups
11203332|NCT02213510|FG000|Participant Flow|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
11203333|NCT02213510|FG001|Participant Flow|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
11203334|NCT02213510|OG000|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
11203335|NCT02213510|OG001|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
11203336|NCT02213510|EG000|Reported Event|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
11203337|NCT02213510|EG001|Reported Event|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
11203338|NCT02213666|BG000|Baseline|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
11203339|NCT02213666|FG000|Participant Flow|Intracardiac and Transesophageal Echocardiography|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
11203340|NCT02213666|OG000|Outcome|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
11203341|NCT02213666|EG000|Reported Event|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
11203342|NCT02213900|BG000|Baseline|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
11203343|NCT02213900|BG001|Baseline|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
11203344|NCT02213900|BG002|Baseline|Total|Total of all reporting groups
11203345|NCT02213900|FG000|Participant Flow|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
10966817|NCT00889330|BG000|Baseline|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
11203346|NCT02213900|FG001|Participant Flow|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
11203347|NCT02213900|OG000|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
10966818|NCT00889330|BG001|Baseline|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
10966819|NCT00889330|BG002|Baseline|Total|Total of all reporting groups
10804126|NCT04190693|FG000|Participant Flow|Cohort 1|Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27
11203348|NCT02213900|OG001|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
10804127|NCT04190693|FG001|Participant Flow|Cohort 2|Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27
10804128|NCT04190693|FG002|Participant Flow|Cohort 3|Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27
10804129|NCT04190693|FG003|Participant Flow|Placebo|Patients having received Placebo in study 2016-003514-27
10804130|NCT04190693|OG000|Outcome|Cohort 1|Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27
10966820|NCT00889330|FG000|Participant Flow|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
10966821|NCT00889330|FG001|Participant Flow|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
11203349|NCT02213900|EG000|Reported Event|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
11203350|NCT02213900|EG001|Reported Event|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
10804131|NCT04190693|OG001|Outcome|Cohort 2|Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27
11203351|NCT02214017|BG000|Baseline|Standard Care|"Diabetic patients attended usual procedure in the outpatient clinic with regular visits~Behavioral motivation: Optimization of medical care in diabetes"
11203352|NCT02214017|BG001|Baseline|Telemedicine Group|"After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.~A videotelephone, TandBerg E20,~Behavioral motivation: Optimization of medical care in diabetes"
11203353|NCT02214017|BG002|Baseline|Total|Total of all reporting groups
10804132|NCT04190693|OG002|Outcome|Cohort 3|Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27
11092510|NCT01540409|BG000|Baseline|Eteplirsen 30 mg/kg|Participants who received 30 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 30 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11092511|NCT01540409|BG001|Baseline|Eteplirsen 50 mg/kg|Participants who received 50 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
10804133|NCT04190693|OG003|Outcome|Placebo|Patients having received Placebo in study 2016-003514-27
11092512|NCT01540409|BG002|Baseline|Total|Total of all reporting groups
11243635|NCT02504671|BG004|Baseline|GSK3196165 135 mg|Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243636|NCT02504671|BG005|Baseline|GSK3196165 180 mg|Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243637|NCT02504671|BG006|Baseline|Total|Total of all reporting groups
11243638|NCT02504671|FG000|Participant Flow|Placebo|Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 milliliter (mL) drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with methotrexate (MTX) tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 milligram (mg)/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243639|NCT02504671|FG001|Participant Flow|GSK3196165 22.5 mg|Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243640|NCT02504671|FG002|Participant Flow|GSK3196165 45 mg|Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243641|NCT02504671|FG003|Participant Flow|GSK3196165 90 mg|Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243642|NCT02504671|FG004|Participant Flow|GSK3196165 135 mg|Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243643|NCT02504671|FG005|Participant Flow|GSK3196165 180 mg|Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243644|NCT02504671|OG000|Outcome|Placebo|Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243645|NCT02504671|OG001|Outcome|GSK3196165 22.5 mg|Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243646|NCT02504671|OG002|Outcome|GSK3196165 45 mg|Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
10966822|NCT00889330|OG000|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
11286132|NCT02884089|FG003|Participant Flow|Sequence 4|Single oral dose of 400 milligram (mg) Abemaciclib or Placebo was administered along with single oral dose of 1000 mg Metformin or 5 mL (3235 mg) Iohexol by Intravenous (IV) infusion on day 1 of each period as per the dosing schedule (Period 1: Abemaciclib + Iohexol;Period 2: Placebo + Iohexol;Period 3: Abemaciclib + Metformin;Period 4: Placebo + Metformin).
11203354|NCT02214017|FG000|Participant Flow|Standard Care|"Diabetic patients attended usual procedure in the outpatient clinic with regular visits~Behavioral motivation: Optimization of medical care in diabetes"
11203355|NCT02214017|FG001|Participant Flow|Telemedicine Group|"After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.~A videotelephone, TandBerg E20,~Behavioral motivation: Optimization of medical care in diabetes"
11203356|NCT02214017|OG000|Outcome|Standard Care|"Diabetic patients attended usual procedure in the outpatient clinic with regular visits~Behavioral motivation: Optimization of medical care in diabetes"
11203357|NCT02214017|OG001|Outcome|Telemedicine Group|"After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.~A videotelephone, TandBerg E20,~Behavioral motivation: Optimization of medical care in diabetes"
11203358|NCT02214017|EG000|Reported Event|Standard Care|"Diabetic patients attended usual procedure in the outpatient clinic with regular visits~Behavioral motivation: Optimization of medical care in diabetes"
11203359|NCT02214017|EG001|Reported Event|Telemedicine Group|"After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.~A videotelephone, TandBerg E20,~Behavioral motivation: Optimization of medical care in diabetes"
11203360|NCT02214121|BG000|Baseline|Part A - Ticagrelor|Actual treatment group for Part A of the study. Relevant for the Part A period.
11203361|NCT02214121|BG001|Baseline|Part B - Ticagrelor|Actual treatment group for Part B of the study. Relevant for the Part B period.
11203362|NCT02214121|BG002|Baseline|Part B - Placebo|Actual treatment group for Part B of the study. Relevant for the Part B period.
11203363|NCT02214121|BG003|Baseline|Total|Total of all reporting groups
11203364|NCT02214121|FG000|Participant Flow|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
11243647|NCT02504671|OG003|Outcome|GSK3196165 90 mg|Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11203365|NCT02214121|FG001|Participant Flow|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203366|NCT02214121|FG002|Participant Flow|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203367|NCT02214121|OG000|Outcome|Ticagrelor 0.125 mg/kg|Single dose received at Visit 2.
11203368|NCT02214121|OG001|Outcome|Ticagrelor 0.75 mg/kg|Single dose received at Visit 2.
11203369|NCT02214121|OG002|Outcome|Ticagrelor 0.375 mg/kg|Single dose received at Visit 3.
11203370|NCT02214121|OG003|Outcome|Ticagrelor 0.563 mg/kg|Single dose received at Visit 3
11203371|NCT02214121|OG004|Outcome|Ticagrelor 1.125 mg/kg|Single dose received at Visit 3.
11203372|NCT02214121|OG005|Outcome|Ticagrelor 2.25 mg/kg|Single dose received at Visit 3.
11203373|NCT02214121|OG006|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
11203374|NCT02214121|OG007|Outcome|Ticagrelor 0.563 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
11203375|NCT02214121|OG008|Outcome|Ticagrelor 0.75 mg/kg Bid|Repeated bid treatment between Visit 3 and Visit 4.
11203376|NCT02214121|OG000|Outcome|Ticagrelor 0.125 mg/kg Bid|Repeated bid treatment during Part B.
11203377|NCT02214121|OG001|Outcome|Placebo|Repeated bid treatment during Part B.
11203378|NCT02214121|OG000|Outcome|Overall|All patients receiving Ticagrelor during Part A.
11203379|NCT02214121|OG000|Outcome|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203380|NCT02214121|OG001|Outcome|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203381|NCT02214121|OG000|Outcome|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
11203382|NCT02214121|EG000|Reported Event|Part A - Ticagrelor|Randomised treatment group for Part A of the study. Relevant for the Part A period.
11203383|NCT02214121|EG001|Reported Event|Part B - Ticagrelor|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203384|NCT02214121|EG002|Reported Event|Part B - Placebo|Randomised treatment group for Part B of the study. Relevant for the Part B period.
11203385|NCT02214147|BG000|Baseline|Alisertib: Normal Hepatic Function|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 50 mg, orally, twice daily (BID) for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 50 mg, BID for 7 days, followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Normal hepatic function includes participants with total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN.
10804134|NCT04190693|EG000|Reported Event|Cohort 1|Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27
11286133|NCT02884089|OG000|Outcome|Placebo + 1000 mg Metformin|Single dose of placebo administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period.
11286134|NCT02884089|OG001|Outcome|400 mg Abemaciclib + 1000 mg Metformin|Single dose of 400 mg Abemaciclib administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period.
11286135|NCT02884089|OG000|Outcome|Placebo + 5 mL Iohexol|Single dose of placebo administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period.
10804135|NCT04190693|EG001|Reported Event|Cohort 2|Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27
11286136|NCT02884089|OG001|Outcome|400 mg Abemaciclib + 5 mL Iohexol|Single dose of 400 mg Abemaciclib administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period.
11286137|NCT02884089|EG000|Reported Event|Placebo + 1000 mg Metformin|Single dose of placebo administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period.
10804136|NCT04190693|EG002|Reported Event|Cohort 3|Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27
11286138|NCT02884089|EG001|Reported Event|400 mg Abemaciclib + 1000 mg Metformin|Single dose of 400 mg Abemaciclib administered orally followed by a single oral dose of 1000 mg Metformin on day 1 of each period.
11243648|NCT02504671|OG004|Outcome|GSK3196165 135 mg|Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
10804137|NCT04190693|EG003|Reported Event|Placebo|Patients having received Placebo in study 2016-003514-27
10804138|NCT04170608|BG000|Baseline|FARAPULSE Endocardial Ablation|"Ablation using the FARAPULSE Endocardial Multi Ablation System~FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System"
10804139|NCT04170608|FG000|Participant Flow|FARAPULSE Endocardial Ablation|"Ablation using the FARAPULSE Endocardial Multi Ablation System~FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System"
10966823|NCT00889330|OG001|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
10804140|NCT04170608|OG000|Outcome|FARAPULSE Endocardial Ablation|"Ablation using the FARAPULSE Endocardial Multi Ablation System~FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System"
10804141|NCT04170608|EG000|Reported Event|FARAPULSE Endocardial Ablation|"Ablation using the FARAPULSE Endocardial Multi Ablation System~FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System"
10804142|NCT04150068|BG000|Baseline|Cohort 1A: Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804143|NCT04150068|BG001|Baseline|Cohort 1B: Placebo to Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804144|NCT04150068|BG002|Baseline|Cohort 2: Lenacapavir|"Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804145|NCT04150068|BG003|Baseline|Total|Total of all reporting groups
10804146|NCT04150068|FG000|Participant Flow|Cohort 1A: Lenacapavir|"Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous anti-retroviral [ARV] regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received subcutaneous (SC) lenacapavir 927 mg and initiated an optimized background regimen (OBR; as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
11286139|NCT02884089|EG002|Reported Event|Placebo + 5 mL Iohexol|Single dose of placebo administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period.
11286140|NCT02884089|EG003|Reported Event|400 mg Abemaciclib + 5 mL Iohexol|Single dose of 400 mg Abemaciclib administered orally followed by a single dose 5 mL (3235 mg) Iohexol administered intravenously (IV) on day 1 of each period.
10820456|NCT00058058|BG000|Baseline|MRI Evaluation of Contralateral Breast|"The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.~MRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study."
10966824|NCT00889330|EG000|Reported Event|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
11243649|NCT02504671|OG005|Outcome|GSK3196165 180 mg|Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
10966825|NCT00889330|EG001|Reported Event|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
10966826|NCT00889512|BG000|Baseline|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
10966827|NCT00889512|BG001|Baseline|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
10966828|NCT00889512|BG002|Baseline|Total|Total of all reporting groups
10966829|NCT00889512|FG000|Participant Flow|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
10847519|NCT00283686|BG000|Baseline|ACE-I/ARB and Standard BP|"ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
10966830|NCT00889512|FG001|Participant Flow|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
10966831|NCT00889512|OG000|Outcome|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
10966832|NCT00889512|OG001|Outcome|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
10804147|NCT04150068|FG001|Participant Flow|Cohort 1B: Placebo to Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804148|NCT04150068|FG002|Participant Flow|Cohort 2: Lenacapavir|"Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804149|NCT04150068|OG000|Outcome|Cohort 1A: Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804150|NCT04150068|OG001|Outcome|Cohort 1B: Placebo to Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804151|NCT04150068|EG000|Reported Event|Cohort 1A: Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received SC lenacapavir 927 mg and initiated an OBR (as prescribed by the Investigator) at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804152|NCT04150068|EG001|Reported Event|Cohort 1B: Placebo to Lenacapavir|"Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit received oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen (previous ARV regimen of any approved and unapproved agents) in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants received oral lenacapavir 600 mg tablet on Days 15 and 16 and 300 mg on Day 22, and initiated an OBR (as prescribed by the Investigator) on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants received SC lenacapavir 927 mg while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
11243650|NCT02504671|EG000|Reported Event|Placebo|Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
10847520|NCT00283686|BG001|Baseline|ACE-I/ARB and Low BP|"ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
11203386|NCT02214147|BG001|Baseline|Alisertib: Moderate Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by alisertib 30 mg, BID for 7 days (Cycle 1 Day 8 to 14), followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 30 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Moderate hepatic impairment includes participants with total bilirubin > 1.5-3 x ULN and any ALT level.
11203387|NCT02214147|BG002|Baseline|Alisertib: Severe Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 20 mg, BID for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 20 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Severe hepatic impairment includes participants with total bilirubin > 3 x ULN and any ALT level.
11203388|NCT02214147|BG003|Baseline|Total|Total of all reporting groups
11203389|NCT02214147|FG000|Participant Flow|Alisertib: Normal Hepatic Function|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 50 mg, orally, twice daily (BID) for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 50 mg, BID for 7 days, followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Normal hepatic function includes participants with total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN.
11203390|NCT02214147|FG001|Participant Flow|Alisertib: Moderate Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by alisertib 30 mg, BID for 7 days (Cycle 1 Day 8 to 14), followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 30 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Moderate hepatic impairment includes participants with total bilirubin > 1.5-3 x ULN and any ALT level.
11203391|NCT02214147|FG002|Participant Flow|Alisertib: Severe Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 20 mg, BID for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 20 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Severe hepatic impairment includes participants with total bilirubin > 3 x ULN and any ALT level.
11203392|NCT02214147|OG000|Outcome|Alisertib: Normal Hepatic Function|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 50 mg, orally, twice daily (BID) for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 50 mg, BID for 7 days, followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Normal hepatic function includes participants with total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN.
11203393|NCT02214147|OG001|Outcome|Alisertib: Moderate Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by alisertib 30 mg, BID for 7 days (Cycle 1 Day 8 to 14), followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 30 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Moderate hepatic impairment includes participants with total bilirubin > 1.5-3 x ULN and any ALT level.
11203394|NCT02214147|OG002|Outcome|Alisertib: Severe Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 20 mg, BID for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 20 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Severe hepatic impairment includes participants with total bilirubin > 3 x ULN and any ALT level.
11203395|NCT02214147|EG000|Reported Event|Alisertib: Normal Hepatic Function|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 50 mg, orally, twice daily (BID) for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 50 mg, BID for 7 days, followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Normal hepatic function includes participants with total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN.
11203396|NCT02214147|EG001|Reported Event|Alisertib: Moderate Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by alisertib 30 mg, BID for 7 days (Cycle 1 Day 8 to 14), followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 30 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Moderate hepatic impairment includes participants with total bilirubin > 1.5-3 x ULN and any ALT level.
11203397|NCT02214147|EG002|Reported Event|Alisertib: Severe Hepatic Impairment|Alisertib 50 mg, orally, once, on Cycle 1 Day 1, followed by, alisertib 20 mg, BID for 7 days (Cycle 1 Day 8 to 14) followed by a 14-day rest period. Starting at Cycle 2 Day 1, alisertib 20 mg, BID for 7 days followed by a 14-day rest period unless a dose reduction is indicated. Participants may continue to receive alisertib until they experience progressive disease or unacceptable alisertib-related toxicities for up to 12 months (approximately 16 cycles), unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Severe hepatic impairment includes participants with total bilirubin > 3 x ULN and any ALT level.
11203398|NCT02214186|BG000|Baseline|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
11203399|NCT02214186|BG001|Baseline|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
11203400|NCT02214186|BG002|Baseline|Total|Total of all reporting groups
11203401|NCT02214186|FG000|Participant Flow|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
11203402|NCT02214186|FG001|Participant Flow|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
11203403|NCT02214186|OG000|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
11203404|NCT02214186|OG001|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
11203405|NCT02214186|EG000|Reported Event|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
11203406|NCT02214186|EG001|Reported Event|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
11203407|NCT02214212|BG000|Baseline|Red Light (RL)|"Intervention/Device:~This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203408|NCT02214212|BG001|Baseline|Bright White Light (BWL)|"Intervention/Device:~This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203409|NCT02214212|BG002|Baseline|Total|Total of all reporting groups
11203410|NCT02214212|FG000|Participant Flow|Red Light (RL)|"Intervention/Device:~This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203411|NCT02214212|FG001|Participant Flow|Bright White Light (BWL)|"Intervention/Device:~This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203412|NCT02214212|OG000|Outcome|Red Light (RL)|The Red Light group was exposed to RL (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
11203413|NCT02214212|OG001|Outcome|Bright White Light (BWL)|The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
11203414|NCT02214212|OG000|Outcome|Red Light (RL)|The Red Light group was exposed to RL (comparator) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
10847521|NCT00283686|BG002|Baseline|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
11203415|NCT02214212|OG000|Outcome|Red Light (RL)|"Intervention/Device:~This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203416|NCT02214212|OG001|Outcome|Bright White Light (BWL)|"Intervention/Device:~This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
10847522|NCT00283686|BG003|Baseline|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
11203417|NCT02214212|OG000|Outcome|Red Light (RL)|This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
10822116|NCT00074490|EG002|Reported Event|Arm IVA (12-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
11203418|NCT02214212|OG001|Outcome|Bright White Light (BWL)|This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
11203419|NCT02214212|EG000|Reported Event|Red Light (RL)|"Intervention/Device:~This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203420|NCT02214212|EG001|Reported Event|Bright White Light (BWL)|"Intervention/Device:~This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.~Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days."
11203421|NCT02214225|BG000|Baseline|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle."
11203422|NCT02214225|BG001|Baseline|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
11203423|NCT02214225|BG002|Baseline|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
11203424|NCT02214225|BG003|Baseline|Total|Total of all reporting groups
11203425|NCT02214225|FG000|Participant Flow|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
11203426|NCT02214225|FG001|Participant Flow|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
11203427|NCT02214225|FG002|Participant Flow|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
11203428|NCT02214225|OG000|Outcome|GMT: bioCSL QIV|Postvaccination GMT.
11203429|NCT02214225|OG001|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|"Postvaccination GMT.~Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850."
11203430|NCT02214225|OG000|Outcome|SCR: bioCSL QIV|bioCSL QIV, n=1691.
11203431|NCT02214225|OG001|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.
11203432|NCT02214225|OG000|Outcome|GMT: bioCSL QIV (18 to <65 Years)|Postvaccination GMT. bioCSL QIV, n=835.
11203433|NCT02214225|OG001|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.
11203434|NCT02214225|OG002|Outcome|GMT: bioCSL QIV (≥ 65 Years)|Postvaccination GMT. bioCSL QIV, n=856.
11203435|NCT02214225|OG003|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.
11203436|NCT02214225|OG000|Outcome|SCR: bioCSL QIV (18 to < 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421."
11203437|NCT02214225|OG001|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
11203438|NCT02214225|OG002|Outcome|SCR: bioCSL QIV (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
11203439|NCT02214225|OG003|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
10847523|NCT00283686|BG004|Baseline|Total|Total of all reporting groups
11203440|NCT02214225|OG000|Outcome|Postvaccination GMT: bioCSL QIV|bioCSL QIV, Adults 18 years and older, N=1691. 18 to < 65 years, n=835. => 65 years, n=856.
10822117|NCT00074490|EG003|Reported Event|Arm IVB (6-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11286141|NCT02884414|BG000|Baseline|Cutaneous Stimulation|"Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.~Cutaneous stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject."
11203441|NCT02214225|OG001|Outcome|Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)|B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.
10966833|NCT00889512|EG000|Reported Event|Group A|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
10966834|NCT00889512|EG001|Reported Event|Group B|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
10966835|NCT00889603|BG000|Baseline|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
10966836|NCT00889603|FG000|Participant Flow|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
10966837|NCT00889603|OG000|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
10966838|NCT00889603|EG000|Reported Event|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
10966839|NCT00889681|BG000|Baseline|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
10966840|NCT00889681|FG000|Participant Flow|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
10966841|NCT00889681|OG000|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
10966842|NCT00889681|EG000|Reported Event|Treated With Cryoablation|"This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF (Atrial Fibrillation Drugs  or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.~Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation."
10966843|NCT00889707|BG000|Baseline|PRX302|0.6 microgram/gram prostate in 2% HSA
10966844|NCT00889707|BG001|Baseline|Placebo|2% HSA without PRX302
10966845|NCT00889707|BG002|Baseline|Total|Total of all reporting groups
10966846|NCT00889707|FG000|Participant Flow|PRX302|0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)
11203442|NCT02214225|OG000|Outcome|SCR: bioCSL QIV|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to <65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856."
11203443|NCT02214225|OG001|Outcome|SCR: Pooled TIV-1 or TIV-2|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to <65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to <65 years, n=424.~B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430."
11203444|NCT02214225|OG000|Outcome|bioCSL QIV (18 to <65 Years)|
11203445|NCT02214225|OG001|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
11203446|NCT02214225|OG002|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
11203447|NCT02214225|OG003|Outcome|bioCSL QIV (≥ 65 Years)|
10966847|NCT00889707|FG001|Participant Flow|Placebo|2% (weight/volume) human serum albumin (HSA) without PRX302
11203448|NCT02214225|OG004|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
11203449|NCT02214225|OG005|Outcome|bioCSL TIV-2 (B/VIC) (≥ 65 Years)|
11203450|NCT02214225|OG005|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
11203451|NCT02214225|OG000|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
11203452|NCT02214225|OG001|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
11203453|NCT02214225|OG002|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
11203454|NCT02214225|EG000|Reported Event|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
10966848|NCT00889707|OG000|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
10966849|NCT00889707|OG001|Outcome|Placebo|2% HSA without PRX302
11203455|NCT02214225|EG001|Reported Event|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
11203456|NCT02214225|EG002|Reported Event|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
11203457|NCT02214238|BG000|Baseline|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
11203458|NCT02214238|BG001|Baseline|Modified PAP Device First, Then Market Released PAP Device|Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
11203459|NCT02214238|BG002|Baseline|Total|Total of all reporting groups
11203460|NCT02214238|FG000|Participant Flow|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
11203461|NCT02214238|FG001|Participant Flow|Modified PAP Device First, Then Market Released PAP Device|Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
11203462|NCT02214238|OG000|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
11203463|NCT02214238|OG001|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
11203464|NCT02214238|EG000|Reported Event|Modified PAP Device|Use of a modified PAP device for 3 more weeks.
11203465|NCT02214238|EG001|Reported Event|Market Released PAP Device|Use of a market released PAP device for 3 more weeks.
11203466|NCT02214277|BG000|Baseline|Safety Arm|Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure.
11203467|NCT02214277|BG001|Baseline|Test Arm|Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
11203468|NCT02214277|BG002|Baseline|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.
11203469|NCT02214277|BG003|Baseline|Total|Total of all reporting groups
10966850|NCT00889707|EG000|Reported Event|PRX302|0.6 microgram/gram prostate in 2% HSA
10966851|NCT00889707|EG001|Reported Event|Placebo|2% HSA without PRX302
10966852|NCT00889720|BG000|Baseline|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
11203470|NCT02214277|FG000|Participant Flow|Safety Arm|"Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure. Safety Arm patients did not receive MRI.~The Safety Arm was combined with the Test Arm for analysis of safety endpoints."
11203471|NCT02214277|FG001|Participant Flow|Test Arm|"Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.~The Test Arm was compared to the Control Arm for analysis of MRI related endpoints, and was combined with the Safety Arm for analysis of safety endpoints."
11203472|NCT02214277|FG002|Participant Flow|Control Arm|"Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.~The Control Arm was compared to the Test arm for MRI related endpoints."
11286142|NCT02884414|FG000|Participant Flow|Cutaneous Stimulation|"Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.~Cutaneous stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject."
11203473|NCT02214277|OG000|Outcome|Test Arm|Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety followup at discharge, at 30 and at 90 days postprocedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days postprocedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days postprocedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
11203474|NCT02214277|OG001|Outcome|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.
11203475|NCT02214277|OG000|Outcome|Safety Cohort|The Safety Cohort is the combination of the Safety and Test Arms.
10966853|NCT00889720|FG000|Participant Flow|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
10966854|NCT00889720|OG000|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
10966855|NCT00889720|EG000|Reported Event|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
10966856|NCT00889824|BG000|Baseline|Balcap Group|Each participant received Balcap Tactile prosthesis
10966857|NCT00889824|FG000|Participant Flow|Balcap Group|"Balcap group~Balcap group; balance prosthesis : vibrotactile stimulation~Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a buzz either in front, back, or either side of their head when they swayed a certain distance from their center.~They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later.~Each patient wore the balcap device a total of six weeks and then returned the device."
10966858|NCT00889824|OG000|Outcome|Balcap Group|Vibrotactile stimulation exercises with the device over a span of 6 weeks
10966859|NCT00889824|EG000|Reported Event|Balcap Group|Each participant received Balcap Tactile prosthesis
10966860|NCT00889863|BG000|Baseline|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966861|NCT00889863|FG000|Participant Flow|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966862|NCT00889863|FG001|Participant Flow|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966863|NCT00889863|OG000|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966864|NCT00889863|OG000|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966865|NCT00889863|OG001|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966866|NCT00889863|EG000|Reported Event|Canakinumab: Part I|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
10966867|NCT00889863|EG001|Reported Event|Canakinumab: Part II|Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
10966868|NCT00889863|EG002|Reported Event|Placebo: Part II|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
11203476|NCT02214277|EG000|Reported Event|Safety Cohort (Test + Safety Arms)|The Safety Cohort is the combination of the Safety and Test Arms. Patients enrolled in these arms of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.
11203477|NCT02214277|EG001|Reported Event|Control Arm|Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.
11203478|NCT02214290|BG000|Baseline|L-Citrulline or Placebo|"Placebo and L-Citrulline pills produced by NOW FOODS, USA~Citrulline or Placebo (both 6g/day) were given for a 7 day supplementation period. This was followed by a 14 day washout period and crossover to the other supplement (L-Citrulline or Placebo) for 7 days. Measurements of arterial function were performed to determine if the supplements had any significant effect on blood pressure control/pressure wave reflection at rest and immediately after ingestion of 200 milligrams of caffeine."
11203479|NCT02214290|FG000|Participant Flow|Citrulline First, Then Placebo|Each participant received L-Citrulline (6g/day) for a 7 day period. This was followed by a 14 day washout period. Finally, the same participants then received a Placebo (6g/day maltodextrin) for a 7 day period.
11203480|NCT02214290|FG001|Participant Flow|Placebo First, Then L-Citrulline|Each participant received a Placebo (6g/day maltodextrin) for a 7 day period. This was followed by a 14 day washout period. Finally, the same participants then received a L-Citrulline (6g/day) for a 7 day period.
11203481|NCT02214290|OG000|Outcome|Citrulline|Participants received 6g/day of Citrulline for 7 days
11203482|NCT02214290|OG001|Outcome|Placebo|Participants received 6 g/day of Maltodextrin for 7 days.
11203483|NCT02214290|OG001|Outcome|Placebo|Participants received 6 g/day of Placebo
11203484|NCT02214290|OG000|Outcome|Citrulline|Participants received a 6 g/day of Citrulline for 7 days
11203485|NCT02214290|OG001|Outcome|Placebo|Participants received a 200 mg maltodextrin tablet, and femoral-ankle pulse wave velocity was taken at 60 minutes post-ingestion.
11203486|NCT02214290|EG000|Reported Event|Citrulline|Participants received 6g/day of Citrulline for 7 days
11203487|NCT02214290|EG001|Reported Event|Placebo|Participants received 6g/day of Placebo (Maltodextrin) for 7 days
11203488|NCT02214420|BG000|Baseline|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
11203489|NCT02214420|BG001|Baseline|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
11203490|NCT02214420|BG002|Baseline|Total|Total of all reporting groups
11203491|NCT02214420|FG000|Participant Flow|SMV+SOF|"Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
11203492|NCT02214420|FG001|Participant Flow|SMV+SOF+RBV|"Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
11203493|NCT02214420|OG000|Outcome|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
11203494|NCT02214420|OG001|Outcome|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
11203495|NCT02214420|EG000|Reported Event|SMV+SOF|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)~Simeprevir~Sofosbuvir"
11203496|NCT02214420|EG001|Reported Event|SMV+SOF+RBV|"IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day~Simeprevir~Sofosbuvir~Ribavirin"
11203497|NCT02214615|BG000|Baseline|Carbamazepine Then Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11243651|NCT02504671|EG001|Reported Event|GSK3196165 22.5 mg|Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 ml/0.5 ml syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243652|NCT02504671|EG002|Reported Event|GSK3196165 45 mg|Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 ml/0.5 ml syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243653|NCT02504671|EG003|Reported Event|GSK3196165 90 mg|Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 ml syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243654|NCT02504671|EG004|Reported Event|GSK3196165 135 mg|Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 ml syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243655|NCT02504671|EG005|Reported Event|GSK3196165 180 mg|Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 ml/3 ml syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
11243656|NCT02504723|BG000|Baseline|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243657|NCT02504723|BG001|Baseline|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243658|NCT02504723|BG002|Baseline|Total|Total of all reporting groups
11243659|NCT02504723|FG000|Participant Flow|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243660|NCT02504723|FG001|Participant Flow|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243661|NCT02504723|OG000|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243662|NCT02504723|OG001|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11286143|NCT02884414|OG000|Outcome|Cutaneous Stimulation|"Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.~Cutaneous stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject."
11203498|NCT02214615|BG001|Baseline|Placebo the Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11203499|NCT02214615|BG002|Baseline|Total|Total of all reporting groups
11215350|NCT02298842|OG000|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11243663|NCT02504723|EG000|Reported Event|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.~carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243664|NCT02504723|EG001|Reported Event|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.~cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
11243665|NCT02504775|BG000|Baseline|Overall Participants|Total number of participants who were randomized and received treatment.
11243666|NCT02504775|FG000|Participant Flow|Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)|Participants first received one tablet of Tylenol® Caplets [500 milligram (mg) of paracetamol], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
11243667|NCT02504775|FG001|Participant Flow|Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)|Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
11243668|NCT02504775|OG000|Outcome|Tylenol® Caplets (Reference)|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
11243669|NCT02504775|OG001|Outcome|Mejoral® 500 Tablets (Test)|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
11243670|NCT02504775|OG000|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
11243671|NCT02504775|OG001|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10966869|NCT00889915|BG000|Baseline|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.~The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.~The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips."
11203500|NCT02214615|FG000|Participant Flow|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11203501|NCT02214615|FG001|Participant Flow|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11243672|NCT02504775|EG000|Reported Event|Tylenol® Caplets|Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
11203502|NCT02214615|OG000|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11203503|NCT02214615|OG001|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11243673|NCT02504775|EG001|Reported Event|Mejoral® 500 Tablets|Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
11092513|NCT01540409|FG000|Participant Flow|Eteplirsen 30 mg/kg|Participants who received 30 milligram per kilogram (mg/kg) eteplirsen or placebo once weekly, intravenous (IV) infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 30 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243674|NCT02504827|BG000|Baseline|IV Ceftazidime/Avibactam|"Ceftazidime/avibactam 2.5gm IV q8h for 3 doses~Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses"
11243675|NCT02504827|FG000|Participant Flow|IV Ceftazidime/Avibactam|"Ceftazidime/avibactam 2.5gm IV q8h for 3 doses~Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses"
11243676|NCT02504827|OG000|Outcome|IV Ceftazidime/Avibactam|"Ceftazidime/avibactam 2.5gm IV q8h for 3 doses~Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses"
11092514|NCT01540409|FG001|Participant Flow|Eteplirsen 50 mg/kg|Participants who received 50 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243677|NCT02504827|EG000|Reported Event|IV Ceftazidime/Avibactam|"Ceftazidime/avibactam 2.5gm IV q8h for 3 doses~Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses"
11092515|NCT01540409|OG000|Outcome|Eteplirsen 30 mg/kg|Participants who received 30 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 30 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11092516|NCT01540409|OG001|Outcome|Eteplirsen 50 mg/kg|Participants who received 50 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11092517|NCT01540409|OG000|Outcome|Placebo to Eteplirsen|Participants who received eteplirsen matched placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), followed by 30 or 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11092518|NCT01540409|OG001|Outcome|Eteplirsen 30 mg/kg|Participants who received 30 mg/kg eteplirsen once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 30 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243678|NCT02504892|BG000|Baseline|Birt-Hogg-Dube Syndrome|"Birt-Hogg-Dube Syndrome (BHD)-associated renal tumors~Everolimus: Everolimus is a commercial agent and is supplied by Novartis."
10966870|NCT00889915|BG001|Baseline|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.~The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided."
11092519|NCT01540409|OG002|Outcome|Eteplirsen 50 mg/kg|Participants who received 50 mg/kg eteplirsen once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243679|NCT02504892|FG000|Participant Flow|Birt-Hogg-Dube Syndrome|"Birt-Hogg-Dube Syndrome (BHD)-associated renal tumors~Everolimus: Everolimus is a commercial agent and is supplied by Novartis."
11092520|NCT01540409|EG000|Reported Event|Eteplirsen 30 mg/kg|Participants who received 30 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 30 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243680|NCT02504892|OG000|Outcome|Birt-Hogg-Dube Syndrome|"Birt-Hogg-Dube Syndrome (BHD)-associated renal tumors~Everolimus: Everolimus is a commercial agent and is supplied by Novartis."
11092521|NCT01540409|EG001|Reported Event|Eteplirsen 50 mg/kg|Participants who received 50 mg/kg eteplirsen or placebo once weekly, IV infusion for 24 weeks in the parent study 4658-us-201 (NCT01396239), continued the same treatment with 50 mg/kg eteplirsen once weekly for 212 weeks (up to Week 240) in this extension study.
11243681|NCT02504892|EG000|Reported Event|Birt-Hogg-Dube Syndrome|"Birt-Hogg-Dube Syndrome (BHD)-associated renal tumors~Everolimus: Everolimus is a commercial agent and is supplied by Novartis."
11243682|NCT02504931|BG000|Baseline|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
11243683|NCT02504931|BG001|Baseline|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
11243684|NCT02504931|BG002|Baseline|Total|Total of all reporting groups
11243685|NCT02504931|FG000|Participant Flow|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
11243686|NCT02504931|FG001|Participant Flow|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
11243687|NCT02504931|OG000|Outcome|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
11243688|NCT02504931|OG001|Outcome|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
11243689|NCT02504931|EG000|Reported Event|Sertraline|"Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.~Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm."
11243690|NCT02504931|EG001|Reported Event|Placebo|"Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline.~Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.~Placebo: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm."
11243691|NCT02505217|BG000|Baseline|High FcγRIIa Expression|Patients with platelet expression of FcγRIIa >11,000/platelet
11243692|NCT02505217|BG001|Baseline|Low FcγRIIa Expression|Patients with platelet expression of FcγRIIa <11,000/platelet
11243693|NCT02505217|BG002|Baseline|Total|Total of all reporting groups
11243694|NCT02505217|FG000|Participant Flow|Patients With MI and High FcGammaRIIa Expression|We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - high expression was >11,000/platelet
11243695|NCT02505217|FG001|Participant Flow|Patients With MI and Low FcGammaRIIa Expression|We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - low expression was <11,000/platelet
11243696|NCT02505217|OG000|Outcome|High FcγRIIa Expression|Platelet FcγRIIa Expression >11,000
11243697|NCT02505217|OG001|Outcome|Low FcγRIIa Expression|Platelet FcγRIIa Expression <11,000
10822118|NCT00074490|EG004|Reported Event|Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11243698|NCT02505217|EG000|Reported Event|Low Platelet Expression of FcGammaRIIa|Patients whose platelet expression of FcGammaRIIa was below 11,000
11243699|NCT02505217|EG001|Reported Event|High Platelet Expression of FcGammaRIIa|Patients whose platelet expression of FcGammaRIIa was > 11,000
11243700|NCT02505269|BG000|Baseline|Brentuximab Vedotin|"The following procedures will take place during study visits beginning after the screening procedures:~- Participants will receive combination therapy:~Brentuximab Vedotin intravenously on predetermined days per cycle~Adriamycin intravenously on predetermined days per cycle~Dacarbazine intravenously on predetermined days per cycle~Brentuximab Vedotin~Adriamycin~Dacarbazine"
11243701|NCT02505269|FG000|Participant Flow|Brentuximab Vedotin|"The following procedures will take place during study visits beginning after the screening procedures:~- Participants will receive combination therapy:~Brentuximab Vedotin intravenously on predetermined days per cycle~Adriamycin intravenously on predetermined days per cycle~Dacarbazine intravenously on predetermined days per cycle~Brentuximab Vedotin~Adriamycin~Dacarbazine"
11243702|NCT02505269|OG000|Outcome|Brentuximab Vedotin|"The following procedures will take place during study visits beginning after the screening procedures:~- Participants will receive combination therapy:~Brentuximab Vedotin intravenously on predetermined days per cycle~Adriamycin intravenously on predetermined days per cycle~Dacarbazine intravenously on predetermined days per cycle~Brentuximab Vedotin~Adriamycin~Dacarbazine"
11243703|NCT02505269|EG000|Reported Event|Brentuximab Vedotin|"The following procedures will take place during study visits beginning after the screening procedures:~- Participants will receive combination therapy:~Brentuximab Vedotin intravenously on predetermined days per cycle~Adriamycin intravenously on predetermined days per cycle~Dacarbazine intravenously on predetermined days per cycle~Brentuximab Vedotin~Adriamycin~Dacarbazine"
11243704|NCT02505334|BG000|Baseline|Liraglutide 1.8 mg|Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
11243705|NCT02505334|BG001|Baseline|Liraglutide 0.9 mg|Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
11243706|NCT02505334|BG002|Baseline|Total|Total of all reporting groups
11243707|NCT02505334|FG000|Participant Flow|Liraglutide 1.8 mg|Subjects received liraglutide once daily subcutaneous (s.c.; under the skin) injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
11243708|NCT02505334|FG001|Participant Flow|Liraglutide 0.9 mg|Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
11243709|NCT02505334|OG000|Outcome|Liraglutide 1.8 mg|Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
11243710|NCT02505334|OG001|Outcome|Liraglutide 0.9 mg|Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
11243711|NCT02505334|EG000|Reported Event|Liraglutide 1.8 mg|Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
11243712|NCT02505334|EG001|Reported Event|Liraglutide 0.9 mg|Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
11243713|NCT02505542|BG000|Baseline|Certolizumab Pegol Open-Label|Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.
11243714|NCT02505542|FG000|Participant Flow|Certolizumab Pegol Open-Label|Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.
11243715|NCT02505542|FG001|Participant Flow|Placebo Double-Blind|Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.
11243716|NCT02505542|FG002|Participant Flow|Certolizumab Pegol 200 mg Q2W Double-Blind|Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.
11243717|NCT02505542|FG003|Participant Flow|Certolizumab Pegol 200 mg Q4W Double-Blind|Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.
10804153|NCT04150068|EG002|Reported Event|Cohort 2: Lenacapavir|"Participants were enrolled in Cohort 2 if Cohort 1 was fully enrolled or if they did not meet the criteria for randomization in Cohort 1 (ie, they had ≥ 0.5 log10 HIV-1 RNA decline compared to the Screening visit and/or HIV-1 RNA < 400 copies/mL at the Cohort Selection visit). Participants received oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants received SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants received their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC).~At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product became accessible to participants through an access program or until Gilead elected to discontinue the study in the country."
10804154|NCT04133519|BG000|Baseline|Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD|"Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).~Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment."
10804155|NCT04133519|BG001|Baseline|MR-1; Muscle Relaxation, Software as a Medical Device - SaMD|"Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)~Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks."
10804156|NCT04133519|BG002|Baseline|Total|Total of all reporting groups
10804157|NCT04133519|FG000|Participant Flow|Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD|"Arm 1 is an active behavioral treatment for Irritable Bowel Syndrome (IBS) (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).~Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment."
10804158|NCT04133519|FG001|Participant Flow|MR-1; Muscle Relaxation, Software as a Medical Device - SaMD|"Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)~Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks."
11203504|NCT02214615|EG000|Reported Event|Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
11203505|NCT02214615|EG001|Reported Event|Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
10804159|NCT04133519|OG000|Outcome|Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD|"Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).~Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment."
10847524|NCT00283686|FG000|Participant Flow|ACE-I/ARB and Standard BP|"ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
10847525|NCT00283686|FG001|Participant Flow|ACE-I/ARB and Low BP|"ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
10847526|NCT00283686|FG002|Participant Flow|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
11203506|NCT02214628|BG000|Baseline|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration"
10804160|NCT04133519|OG001|Outcome|MR-1; Muscle Relaxation, Software as a Medical Device - SaMD|"Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)~Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks."
11203507|NCT02214628|BG001|Baseline|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration"
11203508|NCT02214628|BG002|Baseline|Total|Total of all reporting groups
11203509|NCT02214628|FG000|Participant Flow|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration."
11203510|NCT02214628|FG001|Participant Flow|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration"
11203511|NCT02214628|OG000|Outcome|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration."
11203512|NCT02214628|OG001|Outcome|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration."
11203513|NCT02214628|OG000|Outcome|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration"
11203514|NCT02214628|OG001|Outcome|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration"
11203515|NCT02214628|EG000|Reported Event|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration."
11203516|NCT02214628|EG001|Reported Event|Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen|"Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration."
11203517|NCT02215070|BG000|Baseline|Pasireotide + Preparatory Regimen|Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
11203518|NCT02215070|BG001|Baseline|Historical Controls|Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
11203519|NCT02215070|BG002|Baseline|Total|Total of all reporting groups
11203520|NCT02215070|FG000|Participant Flow|Pasireotide + Preparatory Regimen|Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
11203521|NCT02215070|FG001|Participant Flow|Historical Controls|Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
11203522|NCT02215070|OG000|Outcome|Pasireotide + Preparatory Regimen|Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
11203523|NCT02215070|OG001|Outcome|Historical Controls|Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
11203524|NCT02215070|EG000|Reported Event|Pasireotide + Preparatory Regimen|Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
11203525|NCT02215070|EG001|Reported Event|Historical Controls|Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
11203526|NCT02215161|BG000|Baseline|Treatment (Selinexor)|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3)~Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203527|NCT02215161|FG000|Participant Flow|Treatment (Selinexor)|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3)~Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203528|NCT02215161|OG000|Outcome|Treatment (Selinexor)|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11243718|NCT02505542|OG000|Outcome|Placebo Double-Blind (RS)|"Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.~Participants formed the Randomized Set (RS)."
11243719|NCT02505542|OG001|Outcome|Certolizumab Pegol 200 mg Q2W Double-Blind (RS)|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.~Participants formed the RS."
11243720|NCT02505542|OG002|Outcome|Certolizumab Pegol 200 mg Q4W Double-Blind (RS)|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.~Participants formed the RS."
11203529|NCT02215161|OG000|Outcome|Primary Abiraterone Resistance|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11243721|NCT02505542|OG000|Outcome|Certolizumab Pegol Open-Label (OLS)|"Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.~Participants formed the Open-Label Set (OLS)."
11243722|NCT02505542|OG000|Outcome|Placebo DB/CZP 200 mg Q2W Escape (FS)|"Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the Flared Set (FS)."
11243723|NCT02505542|OG001|Outcome|CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS)|"Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the FS."
11203530|NCT02215161|OG001|Outcome|Aquired Abiraterone Resistance|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203531|NCT02215161|OG000|Outcome|Selinexor Day 1, Course 1|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203532|NCT02215161|OG001|Outcome|Selinexor Day 15, Course 1|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203533|NCT02215161|OG002|Outcome|Selinexor Day 1, Course 2|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203534|NCT02215161|OG003|Outcome|Selinexor Day 1, Course 3|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203535|NCT02215161|OG000|Outcome|Pain at Baseline|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203536|NCT02215161|OG001|Outcome|Pain at Day 1, Course 2 and Following Courses|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3)~5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203537|NCT02215161|EG000|Reported Event|Treatment (Selinexor)|"BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days~Premedication:~Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3)~Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3)~Study drug:~- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity."
11203538|NCT02215200|BG000|Baseline|Anti-Thymocyte Globulin (ATG) and Placebo|"Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose.~Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203539|NCT02215200|BG001|Baseline|ATG Plus Granulocyte Colony Stimulating Factor (GCSF)|"Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg.~GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Granulocyte colony stimulating factor (GCSF): Granulocyte colony stimulating factor (GCSF)"
11203540|NCT02215200|BG002|Baseline|Placebo|"Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses~Placebo (for ATG): Normal saline administered by IV infusion to mimic ATG~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203541|NCT02215200|BG003|Baseline|Total|Total of all reporting groups
11203542|NCT02215200|FG000|Participant Flow|Anti-Thymocyte Globulin (ATG) and Placebo|"Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose.~Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11243724|NCT02505542|OG002|Outcome|CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)|"Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the FS."
11203543|NCT02215200|FG001|Participant Flow|ATG Plus Granulocyte Colony Stimulating Factor (GCSF)|"Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg.~GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Granulocyte colony stimulating factor (GCSF): Granulocyte colony stimulating factor (GCSF)"
11203544|NCT02215200|FG002|Participant Flow|Placebo|"Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses~Placebo (for ATG): Normal saline administered by IV infusion to mimic ATG~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203545|NCT02215200|OG000|Outcome|Anti-Thymocyte Globulin (ATG) and Placebo|"Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose.~Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203546|NCT02215200|OG001|Outcome|ATG Plus Granulocyte Colony Stimulating Factor (GCSF)|"Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg.~GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Granulocyte colony stimulating factor (GCSF): Granulocyte colony stimulating factor (GCSF)"
11203547|NCT02215200|OG002|Outcome|Placebo|"Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses~Placebo (for ATG): Normal saline administered by IV infusion to mimic ATG~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203548|NCT02215200|EG000|Reported Event|Anti-Thymocyte Globulin (ATG) and Placebo|"Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose.~Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203549|NCT02215200|EG001|Reported Event|ATG Plus Granulocyte Colony Stimulating Factor (GCSF)|"Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg.~GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses~Anti-Thymocyte Globulin (ATG): Thymoglobulin~Granulocyte colony stimulating factor (GCSF): Granulocyte colony stimulating factor (GCSF)"
11203550|NCT02215200|EG002|Reported Event|Placebo|"Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses~Placebo (for ATG): Normal saline administered by IV infusion to mimic ATG~Placebo (for GCSF): Placebo prepared to mimic 6mg subcutaneous injection of GCSF"
11203551|NCT02215252|BG000|Baseline|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
11203552|NCT02215252|BG001|Baseline|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
11203553|NCT02215252|BG002|Baseline|Placebo|Participants received matched placebo oral capsule for 4 weeks.
11203554|NCT02215252|BG003|Baseline|Total|Total of all reporting groups
11203555|NCT02215252|FG000|Participant Flow|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
11203556|NCT02215252|FG001|Participant Flow|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
11203557|NCT02215252|FG002|Participant Flow|Placebo|Participants received matched placebo oral capsule for 4 weeks.
11203558|NCT02215252|OG000|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
11203559|NCT02215252|OG001|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
11203560|NCT02215252|OG002|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
11203561|NCT02215252|EG000|Reported Event|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
11203562|NCT02215252|EG001|Reported Event|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
11203563|NCT02215252|EG002|Reported Event|Placebo|Participants received matched placebo oral capsule for 4 weeks.
11203564|NCT02215369|BG000|Baseline|VenaCure EVLT 400 µm Fiber Procedure Kit|"Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.~VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit."
11203565|NCT02215369|FG000|Participant Flow|VenaCure EVLT 400 µm Fiber Procedure Kit|"Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.~VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit."
11203566|NCT02215369|OG000|Outcome|VenaCure EVLT 400 µm Fiber Procedure Kit|"Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.~VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit."
11203567|NCT02215369|EG000|Reported Event|VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population)|"Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.~VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit."
11203568|NCT02215616|BG000|Baseline|Placebo|Participants received 3 capsules of matching laquinimod placebo, orally once daily for 52 weeks.
11203569|NCT02215616|BG001|Baseline|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 2 capsules of matching placebo, orally once daily for 52 weeks.
11203570|NCT02215616|BG002|Baseline|Laquinimod 1.0 mg|Participants received 2 capsules of laquinimod 0.5 mg (total 1.0 mg laquinimod) and 1 capsule of matching placebo, orally once daily for 52 weeks.
11203571|NCT02215616|BG003|Baseline|Laquinimod 1.5 mg|Participants received 3 capsules of laquinimod 0.5 mg (total 1.5 mg laquinimod), orally once daily. The treatment of this high dose arm was discontinued as of 10 January 2016.
11203572|NCT02215616|BG004|Baseline|Total|Total of all reporting groups
11203573|NCT02215616|FG000|Participant Flow|Placebo|Participants received 3 capsules of matching laquinimod placebo, orally once daily for 52 weeks.
11203574|NCT02215616|FG001|Participant Flow|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 2 capsules of matching placebo, orally once daily for 52 weeks.
11203575|NCT02215616|FG002|Participant Flow|Laquinimod 1.0 mg|Participants received 2 capsules of laquinimod 0.5 mg (total 1.0 mg laquinimod) and 1 capsule of matching placebo, orally once daily for 52 weeks.
11203576|NCT02215616|FG003|Participant Flow|Laquinimod 1.5 mg|Participants received 3 capsules of laquinimod 0.5 mg (total 1.5 mg laquinimod), orally once daily. The treatment of this high dose arm was discontinued as of 10 January 2016.
11203577|NCT02215616|OG000|Outcome|Placebo|Participants received 3 capsules of matching laquinimod placebo, orally once daily for 52 weeks.
11203578|NCT02215616|OG001|Outcome|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 2 capsules of matching placebo, orally once daily for 52 weeks.
11203579|NCT02215616|OG002|Outcome|Laquinimod 1.0 mg|Participants received 2 capsules of laquinimod 0.5 mg (total 1.0 mg laquinimod) and 1 capsule of matching placebo, orally once daily for 52 weeks.
11203580|NCT02215616|OG003|Outcome|Laquinimod 1.5 mg|Participants received 3 capsules of laquinimod 0.5 mg (total 1.5 mg laquinimod), orally once daily. The treatment of this high dose arm was discontinued as of 10 January 2016.
11203581|NCT02215616|EG000|Reported Event|Placebo|Participants received 3 capsules of matching laquinimod placebo, orally once daily for 52 weeks.
11203582|NCT02215616|EG001|Reported Event|Laquinimod 0.5 mg|Participants received 1 capsule of laquinimod 0.5 mg and 2 capsules of matching placebo, orally once daily for 52 weeks.
11203583|NCT02215616|EG002|Reported Event|Laquinimod 1.0 mg|Participants received 2 capsules of laquinimod 0.5 mg (total 1.0 mg laquinimod) and 1 capsule of matching placebo, orally once daily for 52 weeks.
11203584|NCT02215616|EG003|Reported Event|Laquinimod 1.5 mg|Participants received 3 capsules of laquinimod 0.5 mg (total 1.5 mg laquinimod), orally once daily. The treatment of this high dose arm was discontinued as of 10 January 2016.
11203585|NCT02215954|BG000|Baseline|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
11203586|NCT02215954|BG001|Baseline|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
11203587|NCT02215954|BG002|Baseline|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
11203588|NCT02215954|BG003|Baseline|Total|Total of all reporting groups
11203589|NCT02215954|FG000|Participant Flow|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
11203590|NCT02215954|FG001|Participant Flow|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
11203591|NCT02215954|FG002|Participant Flow|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
11203592|NCT02215954|OG000|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
11203593|NCT02215954|OG001|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
11203594|NCT02215954|OG002|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
11203595|NCT02215954|OG000|Outcome|Treatment Arm [1]: FE 999169|"One sachet of the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
11203596|NCT02215954|EG000|Reported Event|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy~FE 999169"
11203597|NCT02215954|EG001|Reported Event|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy~FE 999169"
11203598|NCT02215954|EG002|Reported Event|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy~Niflec"
11203599|NCT02215967|BG000|Baseline|0.3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203600|NCT02215967|BG001|Baseline|1 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203601|NCT02215967|BG002|Baseline|3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203602|NCT02215967|BG003|Baseline|9 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203603|NCT02215967|BG004|Baseline|Total|Total of all reporting groups
11203604|NCT02215967|FG000|Participant Flow|0.3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203605|NCT02215967|FG001|Participant Flow|1 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203606|NCT02215967|FG002|Participant Flow|3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203607|NCT02215967|FG003|Participant Flow|9 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203608|NCT02215967|OG000|Outcome|0.3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203609|NCT02215967|OG001|Outcome|1 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203610|NCT02215967|OG002|Outcome|3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11243725|NCT02505542|OG000|Outcome|Placebo Double-Blind (PKSB)|"Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.~Participants formed the Pharmacokinetic Set B (PKSB)."
11243726|NCT02505542|OG001|Outcome|Certolizumab Pegol 200 mg Q2W Double-Blind (PKSB)|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.~Participants formed the PKSB."
11243727|NCT02505542|OG002|Outcome|Certolizumab Pegol 200 mg Q4W Double-Blind (PKSB)|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.~Participants formed the PKSB."
11243728|NCT02505542|OG000|Outcome|Certolizumab Pegol Open-Label (SS) Wk 0-48|"Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.~Participants formed the Safety Set (SS)."
11243729|NCT02505542|OG000|Outcome|Placebo Double-Blind (SSB) Wk 48-96|"Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.~Participants formed the Safety Set Part B (SSB)."
11243730|NCT02505542|OG001|Outcome|Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.~Participants formed the SSB."
11243731|NCT02505542|OG002|Outcome|Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.~Participants formed the SSB."
11243732|NCT02505542|OG000|Outcome|Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the Escape Therapy Set (ETS)."
11243733|NCT02505542|OG001|Outcome|CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the ETS."
11243734|NCT02505542|OG002|Outcome|CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the ETS."
11243735|NCT02505542|EG000|Reported Event|Certolizumab Pegol Open-Label (SS) Wk 0-48|"Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.~Participants formed the Safety Set (SS)."
11243736|NCT02505542|EG001|Reported Event|Placebo Double-Blind (SSB) Wk 48-96|"Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.~Participants formed the Safety Set Part B (SSB)."
11243737|NCT02505542|EG002|Reported Event|Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.~Participants formed the SSB."
11243738|NCT02505542|EG003|Reported Event|Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96|"Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.~Participants formed the SSB."
11243739|NCT02505542|EG004|Reported Event|Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the Escape Therapy Set (ETS)."
11243740|NCT02505542|EG005|Reported Event|CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the ETS."
11243741|NCT02505542|EG006|Reported Event|CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12|"Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.~Participants formed the ETS."
10847527|NCT00283686|FG003|Participant Flow|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
10847528|NCT00283686|OG000|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
10847529|NCT00283686|OG001|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
10847530|NCT00283686|OG002|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
11203611|NCT02215967|OG003|Outcome|9 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203612|NCT02215967|EG000|Reported Event|0.3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203613|NCT02215967|EG001|Reported Event|1 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203614|NCT02215967|EG002|Reported Event|3 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203615|NCT02215967|EG003|Reported Event|9 x 10^6 CAR-BCMA T-cells Infused|"Dose Escalation with 5 dose levels based on the patients actual bodyweight~Cyclophosphamide: 300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3~Fludarabine: 30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3~Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0"
11203616|NCT02216071|BG000|Baseline|Ciprodex®, RLD|"Ciprodex®, Otic Suspension, Twice daily for 7 days~Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203617|NCT02216071|BG001|Baseline|EXL CDOS|"EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days~EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203618|NCT02216071|BG002|Baseline|Total|Total of all reporting groups
11203619|NCT02216071|FG000|Participant Flow|Ciprodex®, RLD|"Ciprodex®, Otic Suspension, Twice daily for 7 days~Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203620|NCT02216071|FG001|Participant Flow|EXL CDOS|"EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days~EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203621|NCT02216071|OG000|Outcome|Ciprodex®, RLD|"Ciprodex®, Otic Suspension, Twice daily for 7 days~Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203622|NCT02216071|OG001|Outcome|EXL CDOS|"EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days~EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203623|NCT02216071|EG000|Reported Event|Ciprodex®, RLD|"Ciprodex®, Otic Suspension, Twice daily for 7 days~Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203624|NCT02216071|EG001|Reported Event|EXL CDOS|"EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days~EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days"
11203625|NCT02216097|BG000|Baseline|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
11203626|NCT02216097|BG001|Baseline|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
11203627|NCT02216097|BG002|Baseline|Total|Total of all reporting groups
11203628|NCT02216097|FG000|Participant Flow|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
11203629|NCT02216097|FG001|Participant Flow|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
11203630|NCT02216097|OG000|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
11203631|NCT02216097|OG001|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
11203632|NCT02216097|EG000|Reported Event|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
11203633|NCT02216097|EG001|Reported Event|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
11203634|NCT02216123|BG000|Baseline|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
11243742|NCT02505867|BG000|Baseline|Device - ASV Therapy|"Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.~Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge."
11243743|NCT02505867|BG001|Baseline|Control|No device provided
11243744|NCT02505867|BG002|Baseline|Total|Total of all reporting groups
11243745|NCT02505867|FG000|Participant Flow|Device - ASV Therapy|"Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.~Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge."
11243746|NCT02505867|FG001|Participant Flow|Control|No device provided
11243747|NCT02505867|OG000|Outcome|Device - ASV Therapy|"Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.~Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge."
11243748|NCT02505867|OG001|Outcome|Control|No device provided
11243749|NCT02505867|EG000|Reported Event|Device - ASV Therapy|"Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.~Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge."
11243750|NCT02505867|EG001|Reported Event|Control|No device provided
11243751|NCT02505919|BG000|Baseline|Treatment|"Aquablation Procedure Utilizing AQUABEAM system:~To utilize proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system."
11243752|NCT02505919|BG001|Baseline|Comparator|"Transurethral Resection of the Prostate (TURP)~Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)"
11243753|NCT02505919|BG002|Baseline|Total|Total of all reporting groups
11243754|NCT02505919|FG000|Participant Flow|Treatment|"AQUABEAM System~AQUABEAM System: To utilizes proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system."
11243755|NCT02505919|FG001|Participant Flow|Control|"Transurethral Resection of the Prostate (TURP)~Transurethral Resection of the Prostate (TURP): Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)"
11243756|NCT02505919|OG000|Outcome|Treatment|"Aquablation Procedure Utilizing AQUABEAM system:~To utilize proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system."
11243757|NCT02505919|OG001|Outcome|Comparator|"Transurethral Resection of the Prostate (TURP)~Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)"
11243758|NCT02505919|EG000|Reported Event|Treatment|"AQUABEAM System~AQUABEAM System: To utilizes proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system."
11243759|NCT02505919|EG001|Reported Event|Control|"Transurethral Resection of the Prostate (TURP)~Transurethral Resection of the Prostate (TURP): Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)"
11243760|NCT02505945|BG000|Baseline|Control Arm|Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
11243761|NCT02505945|BG001|Baseline|Treatment Arm|LINX Reflux Management System
11243762|NCT02505945|BG002|Baseline|Total|Total of all reporting groups
11243763|NCT02505945|FG000|Participant Flow|Control Arm|Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
10847531|NCT00283686|OG003|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
10847532|NCT00283686|EG000|Reported Event|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
10847533|NCT00283686|EG001|Reported Event|ACE-I Alone|ACE-I monotherapy (lisinopril only)
11243764|NCT02505945|FG001|Participant Flow|Treatment Arm|LINX Reflux Management System
11243765|NCT02505945|OG000|Outcome|Control Arm|Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
11243766|NCT02505945|OG001|Outcome|Treatment Arm|LINX Reflux Management System
11243767|NCT02505945|EG000|Reported Event|Control Arm|Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
11243768|NCT02505945|EG001|Reported Event|Treatment Arm|LINX Reflux Management System
11243769|NCT02506036|BG000|Baseline|Control Then Social Cognitive Training|"Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243770|NCT02506036|BG001|Baseline|Social Cognitive Training Then Control|"Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243771|NCT02506036|BG002|Baseline|Total|Total of all reporting groups
10847534|NCT00283686|EG002|Reported Event|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
11203635|NCT02216123|BG001|Baseline|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
11203636|NCT02216123|BG002|Baseline|Total|Total of all reporting groups
11203637|NCT02216123|FG000|Participant Flow|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
10804161|NCT04133519|EG000|Reported Event|Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD|"Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).~Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment."
10847535|NCT00283686|EG003|Reported Event|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
11243772|NCT02506036|FG000|Participant Flow|Control Then Social Cognitive Training|"Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243773|NCT02506036|FG001|Participant Flow|Social Cognitive Training Then Control|"Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243774|NCT02506036|OG000|Outcome|Social Cognitive Training|"This is a combined group of all patients who completed social cognitive training during the study regardless of whether they completed the control condition first or second. The scores reported were taken before and immediately after completion of the training intervention specifically.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243775|NCT02506036|OG001|Outcome|Control|"This is a combined group of all patients who received the control condition and who completed all testing. The scores reported were taken before and immediately after completion of the control portion specifically.~Control: Participants were given an comparable amount (35 hours) of audiobooks to listen to at home over a 4-6 week period."
11243776|NCT02506036|EG000|Reported Event|Social Cognitive Training|"This is a combined group of all patients who received social cognitive training during the study regardless of whether they completed the control condition first or second. This includes patients who did not finish the training but started it.~Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home."
11243777|NCT02506036|EG001|Reported Event|Control|"This is a combined group of all patients who received the control condition during the study. This includes patients who did not finish the control condition but started it.~Control: Participants were given an comparable amount (35 hours) of audiobooks to listen to at home over a 4-6 week period."
11243778|NCT02506114|BG000|Baseline|Arm A: PROSTVAC-V/F|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36.
11243779|NCT02506114|BG001|Baseline|Arm B: Ipilimumab Monotherapy|Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
11243780|NCT02506114|BG002|Baseline|Arm C: Combined PROSTVAC-V/F + Ipilimumab|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
11243781|NCT02506114|BG003|Baseline|Total|Total of all reporting groups
11243782|NCT02506114|FG000|Participant Flow|Arm A: PROSTVAC-V/F|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36.
11243783|NCT02506114|FG001|Participant Flow|Arm B: Ipilimumab Montherapy|Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
11243784|NCT02506114|FG002|Participant Flow|Arm C: Combined PROSTVAC-V/F + Ipilimumab|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
11243785|NCT02506114|OG000|Outcome|Arm A: PROSTVAC-V/F|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36.
11243786|NCT02506114|OG001|Outcome|Arm B: Ipilimumab Monotherapy|Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
11243787|NCT02506114|OG002|Outcome|Arm C: Combined PROSTVAC-V/F + Ipilimumab|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
11243788|NCT02506114|EG000|Reported Event|Arm A: PROSTVAC-V/F|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36.
11243789|NCT02506114|EG001|Reported Event|Arm B: Ipilimumab Monotherapy|Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
11243790|NCT02506114|EG002|Reported Event|Arm C: Combined PROSTVAC-V/F + Ipilimumab|PROSTVAC-V: 2 x 10^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.
11243791|NCT02506257|BG000|Baseline|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243792|NCT02506257|BG001|Baseline|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243793|NCT02506257|BG002|Baseline|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243794|NCT02506257|BG003|Baseline|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243795|NCT02506257|BG004|Baseline|Total|Total of all reporting groups
11203638|NCT02216123|FG001|Participant Flow|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
11243796|NCT02506257|FG000|Participant Flow|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243797|NCT02506257|FG001|Participant Flow|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243798|NCT02506257|FG002|Participant Flow|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243799|NCT02506257|FG003|Participant Flow|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243800|NCT02506257|OG000|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243801|NCT02506257|OG001|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243802|NCT02506257|OG002|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243803|NCT02506257|OG003|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243804|NCT02506257|EG000|Reported Event|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243805|NCT02506257|EG001|Reported Event|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243806|NCT02506257|EG002|Reported Event|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243807|NCT02506257|EG003|Reported Event|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
11243808|NCT02506309|BG000|Baseline|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243809|NCT02506309|BG001|Baseline|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243810|NCT02506309|BG002|Baseline|Total|Total of all reporting groups
11243811|NCT02506309|FG000|Participant Flow|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243812|NCT02506309|FG001|Participant Flow|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243813|NCT02506309|OG000|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243814|NCT02506309|OG001|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243815|NCT02506309|EG000|Reported Event|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11243816|NCT02506309|EG001|Reported Event|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
11203639|NCT02216123|OG000|Outcome|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
11203640|NCT02216123|OG001|Outcome|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
11203641|NCT02216123|OG000|Outcome|First Malaria Relapse|Participants from all treatment arms (CQ+TQ and PQ+TQ) with a relapse episode of malaria were included.
11203642|NCT02216123|OG001|Outcome|First Malaria Relapse Follow-up|Participants from all treatment arms (CQ+TQ and PQ+TQ) who had a follow-up visit for relapse episode of malaria were included.
11203643|NCT02216123|OG000|Outcome|Participants With Clinically Relevant Hemolysis|Participants from both treatment arms (TQ + CQ and PQ + CQ) with clinically relevant hemolysis were included.
11203644|NCT02216123|OG000|Outcome|Participants in TQ Only Arms|TQ only arms
11203645|NCT02216123|EG000|Reported Event|TQ+CQ|Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration.
11203646|NCT02216123|EG001|Reported Event|PQ+CQ|Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration.
11203647|NCT02216136|BG000|Baseline|Breast Conservation Cohort|Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
11203648|NCT02216136|BG001|Baseline|Mastectomy and Reconstruction Cohort|Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
11203649|NCT02216136|BG002|Baseline|Mastectomy Only Cohort|Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
11203650|NCT02216136|BG003|Baseline|Total|Total of all reporting groups
11203651|NCT02216136|FG000|Participant Flow|Breast Conservation Cohort|Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
11203652|NCT02216136|FG001|Participant Flow|Mastectomy and Reconstruction Cohort|Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
11203653|NCT02216136|FG002|Participant Flow|Mastectomy Only Cohort|Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
11203654|NCT02216136|OG000|Outcome|Breast Conservation Cohort|Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
11243817|NCT02506634|BG000|Baseline|Patients With Predominant Heartburn|Patients with predominant heartburn were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11203655|NCT02216136|OG001|Outcome|Mastectomy and Reconstruction Cohort|Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
11203656|NCT02216136|OG002|Outcome|Mastectomy Only Cohort|Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
11203657|NCT02216136|EG000|Reported Event|Breast Conservation Cohort|Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.
11203658|NCT02216136|EG001|Reported Event|Mastectomy and Reconstruction Cohort|Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
11203659|NCT02216136|EG002|Reported Event|Mastectomy Only Cohort|Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
11203660|NCT02216214|BG000|Baseline|Placebo|Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203661|NCT02216214|BG001|Baseline|Mirabegron|Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203662|NCT02216214|BG002|Baseline|Total|Total of all reporting groups
11203663|NCT02216214|FG000|Participant Flow|Placebo|Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11243818|NCT02506634|BG001|Baseline|Patients With Predominant Regurgitation|Patients with predominant regurgitation were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243819|NCT02506634|BG002|Baseline|Patients With Predominant Chest Pain|Patients with predominant chest pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243820|NCT02506634|BG003|Baseline|Patients With Predominant Dysphagia|Patients with predominant dysphagia were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243821|NCT02506634|BG004|Baseline|Patients With Predominant Epigastric Pain|Patients with predominant epigastric pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243822|NCT02506634|BG005|Baseline|Patients With Predominant Epigastric Burning|Patients with predominant epigastric burning were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243823|NCT02506634|BG006|Baseline|Patients With Predominant Postprandial Fullness|Patients with predominant postprandial fullness were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243824|NCT02506634|BG007|Baseline|Patients With Predominant Early Satiety|Patients with predominant early satiety were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
11243825|NCT02506634|BG008|Baseline|Total|Total of all reporting groups
11243826|NCT02506634|FG000|Participant Flow|Patients With Upper GI Symptoms|Participants were stratified at baseline based on their main gastrointestinal symptoms and then evaluated for GERD using different methods. They also recieved PPI treatment (Esomeprazole MUPS, 20 mg, bid, 4 or 8 weeks) and finished GERDQ.
11243827|NCT02506634|OG000|Outcome|GERD Patients Defined by Reflux Esophagitis on Endoscopy|The percentage of GERD patients with different predominant symptom will be calculated.
11243828|NCT02506634|OG001|Outcome|GERD Patients Defined by Positive AET on Reflux Monitoring|The percentage of GERD patients with different predominant symptom will be calculated.
11243829|NCT02506634|OG002|Outcome|GERD Patients Defined by Either Endoscopy or Reflux Monitoring|The percentage of GERD patients with different predominant symptom will be calculated.
11243830|NCT02506634|OG000|Outcome|Patients With Predominant Heartburn|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant heartburn will be calculated.
11243831|NCT02506634|OG001|Outcome|Patients With Predominant Regurgitation|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant regurgitation will be calculated.
11243832|NCT02506634|OG002|Outcome|Patients With Predominant Chest Pain|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant chest pain will be calculated.
11243833|NCT02506634|OG003|Outcome|Patients With Predominant Dysphagia|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
11243834|NCT02506634|OG004|Outcome|Patients With Predominant Epigastric Pain|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant epigastric pain will be calculated.
11243835|NCT02506634|OG005|Outcome|Patients With Predominant Epigastric Burning|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant epigastric burning will be calculated.
11243836|NCT02506634|OG006|Outcome|Patients With Predominant Postprandial Fullness|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant postprandial fullness will be calculated.
11243837|NCT02506634|OG007|Outcome|Patients With Predominant Early Satiety|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant early satiety will be calculated.
11243838|NCT02506634|OG000|Outcome|Patients With Predominant Heartburn|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant heartburn will be calculated.
11243839|NCT02506634|OG001|Outcome|Patients With Predominant Regurgitation|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant regurgitation will be calculated.
11243840|NCT02506634|OG002|Outcome|Patients With Predominant Chest Pain|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant chest pain will be calculated.
11243841|NCT02506634|OG003|Outcome|Patients With Predominant Dysphagia|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant dysphagia will be calculated.
11243842|NCT02506634|OG004|Outcome|Patients With Predominant Epigastric Pain|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant epigastric pain will be calculated.
11243843|NCT02506634|OG005|Outcome|Patients With Predominant Epigastric Burning|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant epigastric burning will be calculated.
11243844|NCT02506634|OG006|Outcome|Patients With Predominant Postprandial Fullness|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant postprandial fullness will be calculated.
11243845|NCT02506634|OG007|Outcome|Patients With Predominant Early Satiety|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant early satiety will be calculated.
11243846|NCT02506634|OG000|Outcome|GERD Patients With Predominant Heartburn|The life quality of GERD patients with predominant heartburn will be measured via the MOS 36-item short form health survey (SF-36).
11243847|NCT02506634|OG001|Outcome|GERD Patients With Predominant Regurgitation|The life quality of GERD patients with predominant regurgitation will be measured via the MOS 36-item short form health survey (SF-36).
11203664|NCT02216214|FG001|Participant Flow|Mirabegron|Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203665|NCT02216214|OG000|Outcome|Placebo|Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203666|NCT02216214|OG001|Outcome|Mirabegron|Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203667|NCT02216214|EG000|Reported Event|Placebo|Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203668|NCT02216214|EG001|Reported Event|Mirabegron|Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
11203669|NCT02216357|BG000|Baseline|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
11203670|NCT02216357|BG001|Baseline|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
11203671|NCT02216357|BG002|Baseline|Total|Total of all reporting groups
11203672|NCT02216357|FG000|Participant Flow|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
11203673|NCT02216357|FG001|Participant Flow|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
11203674|NCT02216357|OG000|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
11203675|NCT02216357|OG001|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
11203676|NCT02216357|EG000|Reported Event|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
11203677|NCT02216357|EG001|Reported Event|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
11203678|NCT02216422|BG000|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
11203679|NCT02216422|FG000|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
11203680|NCT02216422|OG000|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
11203681|NCT02216422|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
11203682|NCT02216526|BG000|Baseline|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
11203683|NCT02216526|BG001|Baseline|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
11203684|NCT02216526|BG002|Baseline|Standard Skin Care|Usual skin care routine of the nursing home resident
11203685|NCT02216526|BG003|Baseline|Total|Total of all reporting groups
11203686|NCT02216526|FG000|Participant Flow|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
11203687|NCT02216526|FG001|Participant Flow|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
11203688|NCT02216526|FG002|Participant Flow|Standard Skin Care|Usual skin care routine of the nursing home resident
11203689|NCT02216526|OG000|Outcome|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
11203690|NCT02216526|OG001|Outcome|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
11203691|NCT02216526|OG002|Outcome|Standard Skin Care|Usual skin care routine of the nursing home resident
11203692|NCT02216526|EG000|Reported Event|Cetaphil® Restoraderm|"Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks~Cetaphil® Restoraderm"
11203693|NCT02216526|EG001|Reported Event|Excipial|"Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks~Excipial"
11203694|NCT02216526|EG002|Reported Event|Standard Skin Care|Usual skin care routine of the nursing home resident
11243848|NCT02506634|OG002|Outcome|GERD Patients With Predominant Chest Pain|The life quality of GERD patients with predominant chest pain will be measured via the MOS 36-item short form health survey (SF-36).
10966871|NCT00889915|BG002|Baseline|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
11243849|NCT02506634|OG003|Outcome|GERD Patients With Predominant Dysphagia|The life quality of GERD patients with predominant dysphagia will be measured via the MOS 36-item short form health survey (SF-36).
11243850|NCT02506634|OG004|Outcome|GERD Patients With Predominant Epigastric Pain|The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
11243851|NCT02506634|OG005|Outcome|GERD Patients With Predominant Epigastric Burning|The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
11243852|NCT02506634|OG006|Outcome|GERD Patients With Predominant Postprandial Fullness|The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
11243853|NCT02506634|OG007|Outcome|GERD Patients With Predominant Early Satiety|The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
11243854|NCT02506634|OG000|Outcome|Patients With Typical Reflux Symptoms|The sensitivity of PPI test for the diagnosis of GERD in patients with typical reflux symptoms will be calculated.
10966872|NCT00889915|BG003|Baseline|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.~The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods."
11243855|NCT02506634|OG001|Outcome|Patients With Atypical Symptoms|The sensitivity of PPI test for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated.
11243856|NCT02506634|OG000|Outcome|Patients With Typical Reflux Symptoms|The specificity of PPI test for the diagnosis of GERD in patients with typical reflux symptoms will be calculated.
10966873|NCT00889915|BG004|Baseline|Total|Total of all reporting groups
10966874|NCT00889915|FG000|Participant Flow|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
10966875|NCT00889915|FG001|Participant Flow|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
11243857|NCT02506634|OG001|Outcome|Patients With Atypical Symptoms|The specificity of PPI test for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated.
11243858|NCT02506634|OG000|Outcome|Patients With Typical Reflux Symptoms|The sensitivity of GERDQ for the diagnosis of GERD in patients with typical reflux symptoms will be calculated.
10966876|NCT00889915|FG002|Participant Flow|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
11243859|NCT02506634|OG001|Outcome|Patients With Atypical Symptoms|The sensitivity of GERDQ for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated.
10966877|NCT00889915|FG003|Participant Flow|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
10966878|NCT00889915|OG000|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
10966879|NCT00889915|OG001|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
10966880|NCT00889915|OG002|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
10966881|NCT00889915|OG003|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
10966882|NCT00889915|EG000|Reported Event|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
10966883|NCT00889915|EG001|Reported Event|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
11243860|NCT02506634|OG000|Outcome|Patients With Typical Reflux Symptoms|The specificity of GERDQ for the diagnosis of GERD in patients with typical reflux symptoms will be calculated.
10966884|NCT00889915|EG002|Reported Event|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
10966885|NCT00889915|EG003|Reported Event|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
10966886|NCT00889928|BG000|Baseline|Cholecystectomy|transvaginal cholecystectomy
10966887|NCT00889928|FG000|Participant Flow|Cholecystectomy|transvaginal cholecystectomy
10966888|NCT00889928|OG000|Outcome|Transvaginal Cholecystectomy|
10966889|NCT00889928|EG000|Reported Event|Cholecystectomy|transvaginal cholecystectomy
10966890|NCT00890045|BG000|Baseline|Control Group|Conventional Arteriovenous ePTFE Graft Recipients
11243861|NCT02506634|OG001|Outcome|Patients With Atypical Symptoms|The specificity of GERDQ for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated.
10966891|NCT00890045|BG001|Baseline|HeRO Group|HeRO Graft Recipients
10966892|NCT00890045|BG002|Baseline|Total|Total of all reporting groups
10966893|NCT00890045|FG000|Participant Flow|Control Graft|Conventional ePTFE hemodialysis graft
10966894|NCT00890045|FG001|Participant Flow|HeRO Vascular Access Device|HeRO Vascular Access Device: HeRO Vascular Access Device
10966895|NCT00890045|OG000|Outcome|Control Group|Conventional Arteriovenous ePTFE Graft Recipients
10966896|NCT00890045|OG001|Outcome|HeRO Group|HeRO Graft Recipients
10966897|NCT00890045|EG000|Reported Event|Control Group|Conventional Arteriovenous ePTFE Graft Recipients
10966898|NCT00890045|EG001|Reported Event|HeRO Group|HeRO Graft Recipients
10966899|NCT00890084|BG000|Baseline|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
10966900|NCT00890084|FG000|Participant Flow|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
10966901|NCT00890084|OG000|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
10966902|NCT00890084|EG000|Reported Event|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
10966903|NCT00890097|BG000|Baseline|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
10966904|NCT00890097|BG001|Baseline|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966905|NCT00890097|BG002|Baseline|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966906|NCT00890097|BG003|Baseline|Total|Total of all reporting groups
10966907|NCT00890097|FG000|Participant Flow|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
10966908|NCT00890097|FG001|Participant Flow|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966909|NCT00890097|FG002|Participant Flow|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966910|NCT00890097|OG000|Outcome|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
10966911|NCT00890097|OG001|Outcome|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966912|NCT00890097|OG002|Outcome|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966913|NCT00890097|EG000|Reported Event|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
10966914|NCT00890097|EG001|Reported Event|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966915|NCT00890097|EG002|Reported Event|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
10966916|NCT00890162|BG000|Baseline|Omalizumab|Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966917|NCT00890162|BG001|Baseline|Placebo|Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966918|NCT00890162|BG002|Baseline|Total|Total of all reporting groups
10966919|NCT00890162|FG000|Participant Flow|Omalizumab|Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
11243862|NCT02506634|EG000|Reported Event|Patients Who Received PPI Treatment|The frequency of adverse events among patients who received PPI treatment was calculated.
11243863|NCT02506660|BG000|Baseline|Intravenous Dexamethasone|"Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.~Bupivacaine~Intravenous dexamethasone~Perineural saline: Saline in nerve block"
10966920|NCT00890162|FG001|Participant Flow|Placebo|Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966921|NCT00890162|OG000|Outcome|Omalizumab|Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966922|NCT00890162|OG001|Outcome|Placebo|Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966923|NCT00890162|EG000|Reported Event|Omalizumab|Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966924|NCT00890162|EG001|Reported Event|Placebo|Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
10966925|NCT00890201|BG000|Baseline|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
10966926|NCT00890201|BG001|Baseline|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
10966927|NCT00890201|BG002|Baseline|Total|Total of all reporting groups
10966928|NCT00890201|FG000|Participant Flow|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
10966929|NCT00890201|FG001|Participant Flow|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
10966930|NCT00890201|OG000|Outcome|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
10966931|NCT00890201|OG001|Outcome|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
11243864|NCT02506660|BG001|Baseline|Perineural Dexamethasone|"Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.~Bupivacaine~Perineural dexamethasone: Dexamethasone in nerve block~Intravenous saline"
10966932|NCT00890201|EG000|Reported Event|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
10966933|NCT00890201|EG001|Reported Event|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
10966934|NCT00890396|BG000|Baseline|Active|An active follow-up involved the performance of many of the laboratory tests and procedures done during BABY HUG clinical trials study. These included, but not limited to, serial laboratory parameters that were not part of routine clinical care such as Hgb F levels, pitted cell count, Howell-Jolly Body determination, a liver-spleen scan, DTPA GFR measurement, creatinine clearance, Cystatin C, urine concentrating ability, transcranial Doppler, and neuropsychological testing. Patients could be on or off hydroxyurea at the start of Follow-Up Study I, and could change treatment during the study.
10966935|NCT00890396|BG001|Baseline|Passive|A passive follow-up involved the abstraction of clinical data from the medical record. Results of physical examinations and laboratory tests performed as part of routine clinical care were recorded. Patients could be on or off hydroxyurea at the start of Follow-Up Study I, and could change treatment during the study.
10966936|NCT00890396|BG002|Baseline|Total|Total of all reporting groups
10966937|NCT00890396|FG000|Participant Flow|Active|An active follow-up involved the performance of many of the laboratory tests and procedures done during BABY HUG clinical trials study. These included, but not limited to, serial laboratory parameters that were not part of routine clinical care such as Hgb F levels, pitted cell count, Howell-Jolly Body determination, a liver-spleen scan, diethylenetriaminepentaacetic acid (DTPA) glomerular filtration rate (GFR) measurement, creatinine clearance, Cystatin C, urine concentrating ability, transcranial Doppler, and neuropsychological testing.
10966938|NCT00890396|FG001|Participant Flow|Passive|A passive follow-up involved the abstraction of clinical data from the medical record. Results of physical examinations and laboratory tests performed as part of routine clinical care were recorded.
10966939|NCT00890396|OG000|Outcome|Randomized to Hydroxyurea|Subjects randomized to Hydroxyurea in the randomized phase III clinical trial.
10966940|NCT00890396|OG001|Outcome|Randomized to Placebo|Subjects randomized to Placebo in the randomized phase III clinical trial.
11243865|NCT02506660|BG002|Baseline|Total|Total of all reporting groups
11243866|NCT02506660|FG000|Participant Flow|Intravenous Dexamethasone|"Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.~Bupivacaine~Intravenous dexamethasone~Perineural saline: Saline in nerve block"
10966941|NCT00890396|OG000|Outcome|On Hydroxyurea at the Time of Visit|Subjects who were on hydroxyurea at the time of study visit
10966942|NCT00890396|OG001|Outcome|Off Hydroxyurea at the Time of Visit|Subjects who were off hydroxyurea at the time of study visit
10966943|NCT00890396|OG001|Outcome|Randomized to Placebo|Subjects randomized to placebo in the randomized phase III clinical trial.
10966944|NCT00890396|EG000|Reported Event|Randomized to Hydroxyurea|Subjects randomized to Hydroxyurea in the randomized phase III clinical trial.
10966945|NCT00890396|EG001|Reported Event|Randomized to Placebo|Subjects randomized to Placebo in the randomized phase III clinical trial.
10966946|NCT00890552|BG000|Baseline|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
10966947|NCT00890552|FG000|Participant Flow|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
10966948|NCT00890552|OG000|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
10966949|NCT00890552|EG000|Reported Event|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
10966950|NCT00890617|BG000|Baseline|Prednisone & Cryotherapy|"Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure~Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).~Prednisone: Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure"
10966951|NCT00890617|FG000|Participant Flow|Prednisone & Cryotherapy|"Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure~Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).~Prednisone: Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure"
10966952|NCT00890617|OG000|Outcome|Prednisone & Cryotherapy|"Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure~Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).~Prednisone: Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure"
10966953|NCT00890617|EG000|Reported Event|Prednisone & Cryotherapy|"Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure~Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).~Prednisone: Prednisone taken:~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure"
10966954|NCT00890656|BG000|Baseline|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
10966955|NCT00890656|FG000|Participant Flow|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
10966956|NCT00890656|OG000|Outcome|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
11243867|NCT02506660|FG001|Participant Flow|Perineural Dexamethasone|"Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.~Bupivacaine~Perineural dexamethasone: Dexamethasone in nerve block~Intravenous saline"
11243868|NCT02506660|OG000|Outcome|Intravenous Dexamethasone|"Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.~Bupivacaine~Intravenous dexamethasone~Perineural saline: Saline in nerve block"
10966957|NCT00890656|EG000|Reported Event|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
10966958|NCT00890682|BG000|Baseline|Sky0402|Injection of Study Drug
10966959|NCT00890682|BG001|Baseline|Placebo|Study Drug Injection
10966960|NCT00890682|BG002|Baseline|Total|Total of all reporting groups
10966961|NCT00890682|FG000|Participant Flow|SKY0402|Injection of 8cc SKY0402 (single dose)
10966962|NCT00890682|FG001|Participant Flow|Placebo|Injection of 8cc Placebo (single dose)
11243869|NCT02506660|OG001|Outcome|Perineural Dexamethasone|"Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.~Bupivacaine~Perineural dexamethasone: Dexamethasone in nerve block~Intravenous saline"
10966963|NCT00890682|OG000|Outcome|SKY0402|Single injection of study drug
10966964|NCT00890682|OG001|Outcome|Placebo|Single injection of study drug
10966965|NCT00890682|EG000|Reported Event|Sky0402|Injection of Study Drug
10966966|NCT00890682|EG001|Reported Event|Placebo|Study Drug Injection
10966967|NCT00890695|BG000|Baseline|1 RUSF|RUSF prescribed for the child for 4 weeks
10966968|NCT00890695|BG001|Baseline|2 Normal Diet|normal diet arm
10966969|NCT00890695|BG002|Baseline|Total|Total of all reporting groups
10966970|NCT00890695|FG000|Participant Flow|1 Ready to Use Supplementary Food (RUSF)|"Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).~initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."
10966971|NCT00890695|FG001|Participant Flow|2 Normal Diet|For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.
10966972|NCT00890695|OG000|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
10966973|NCT00890695|OG001|Outcome|2 Normal Diet|normal diet arm
10966974|NCT00890695|EG000|Reported Event|1 RUSF|RUSF prescribed for the child for 4 weeks
10966975|NCT00890695|EG001|Reported Event|2 Normal Diet|normal diet arm
10966976|NCT00890721|BG000|Baseline|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
10966977|NCT00890721|BG001|Baseline|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
10966978|NCT00890721|BG002|Baseline|Total|Total of all reporting groups
10966979|NCT00890721|FG000|Participant Flow|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
10966980|NCT00890721|FG001|Participant Flow|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
10966981|NCT00890721|OG000|Outcome|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
10966982|NCT00890721|OG001|Outcome|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
10966983|NCT00890721|EG000|Reported Event|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
10966984|NCT00890721|EG001|Reported Event|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
10966985|NCT00890825|BG000|Baseline|AZD6244 + Docetaxel|AZD6244 75 mg bd + Docetaxel 75 mg/m^2
10966986|NCT00890825|BG001|Baseline|Placebo + Docetaxel|Placebo + Docetaxel 75 mg/m^2
10966987|NCT00890825|BG002|Baseline|Total|Total of all reporting groups
10966988|NCT00890825|FG000|Participant Flow|AZD6244 + Docetaxel|AZD6244 75 mg bd + Docetaxel 75 mg/m^2
10966989|NCT00890825|FG001|Participant Flow|Placebo + Docetaxel|Placebo + Docetaxel 75 mg/m^2
10966990|NCT00890825|OG000|Outcome|AZD6244 + Docetaxel|AZD6244 75 mg bd + Docetaxel 75 mg/m^2
10966991|NCT00890825|OG001|Outcome|Placebo + Docetaxel|Placebo + Docetaxel 75 mg/m^2
10966992|NCT00890825|EG000|Reported Event|AZD6244 + Docetaxel|AZD6244 75 mg bd + Docetaxel 75 mg/m^2
10966993|NCT00890825|EG001|Reported Event|Placebo + Docetaxel|Placebo + Docetaxel 75 mg/m^2
10966994|NCT00890916|BG000|Baseline|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System."
10966995|NCT00890916|FG000|Participant Flow|Neuroprosthesis System|Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
10966996|NCT00890916|OG000|Outcome|Neuroprosthesis System|Subjects with the implanted FIRSTHAND/IST-12 System.
10966997|NCT00890916|EG000|Reported Event|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels."
11243870|NCT02506660|EG000|Reported Event|Intravenous Dexamethasone|"Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.~Bupivacaine~Intravenous dexamethasone~Perineural saline: Saline in nerve block"
11203695|NCT02216591|BG000|Baseline|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
11203696|NCT02216591|BG001|Baseline|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
11203697|NCT02216591|BG002|Baseline|Total|Total of all reporting groups
11203698|NCT02216591|FG000|Participant Flow|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
11203699|NCT02216591|FG001|Participant Flow|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
11203700|NCT02216591|OG000|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
11203701|NCT02216591|OG001|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
11203702|NCT02216591|EG000|Reported Event|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.~Active Cognitive Training (ACT)"
11203703|NCT02216591|EG001|Reported Event|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.~Control (CON)"
11203704|NCT02216695|BG000|Baseline|Acute Kidney Injury|we analysed acute kidney injury requiring dialysis in England
11203705|NCT02216695|FG000|Participant Flow|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
11203706|NCT02216695|OG000|Outcome|1998-03|All patients who had acute kidney injury and required dialysis between 1998 and 2013 were identified from hospital episode statistic.Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
11203707|NCT02216695|OG001|Outcome|2003-08|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
11203708|NCT02216695|OG002|Outcome|2008-13|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
11203709|NCT02216695|OG000|Outcome|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
11203710|NCT02216695|OG000|Outcome|Acute Kidney Injury Requiring Dialysis|Age was categorized into the groups 65, 65-74, 75-84, and > 85. The associations between discharge status was tested with multivariable regression model which included gender, age group, discharge period, admission method, CCS, ethnicity, and AKI in diagnoses code.
11203711|NCT02216695|OG000|Outcome|Acute Kidney Injury Requiring Dialysis|The associations between discharge status was tested with multivariable regression model which included age group and discharge period,
11203712|NCT02216695|EG000|Reported Event|Dialysis Requiring AKI|AKI patients who required renal replacement therapy
11203713|NCT02216773|BG000|Baseline|Portal Vein Embolization (PVE)|"Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.~Portal vein embolization (PVE)"
11243871|NCT02506660|EG001|Reported Event|Perineural Dexamethasone|"Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.~Bupivacaine~Perineural dexamethasone: Dexamethasone in nerve block~Intravenous saline"
11203714|NCT02216773|BG001|Baseline|Radiofrequency Assisted Liver Partition and Ligation (RALPPS)|"Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.~Radiofrequency assisted liver partition with portal vein ligation (RALPPS)"
11203715|NCT02216773|BG002|Baseline|Total|Total of all reporting groups
11203716|NCT02216773|FG000|Participant Flow|Portal Vein Embolization (PVE)|"Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.~Portal vein embolization (PVE)"
11203717|NCT02216773|FG001|Participant Flow|Radiofrequency Assisted Liver Partition and Ligation (RALPPS)|"Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.~Radiofrequency assisted liver partition with portal vein ligation (RALPPS)"
11203718|NCT02216773|OG000|Outcome|Portal Vein Embolization (PVE)|"Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.~Portal vein embolization (PVE)"
11203719|NCT02216773|OG001|Outcome|Radiofrequency Assisted Liver Partition and Ligation (RALPPS)|"Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.~Radiofrequency assisted liver partition with portal vein ligation (RALPPS)"
11203720|NCT02216773|EG000|Reported Event|Portal Vein Embolization (PVE)|"Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.~Portal vein embolization (PVE)"
11203721|NCT02216773|EG001|Reported Event|Radiofrequency Assisted Liver Partition and Ligation (RALPPS)|"Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.~Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.~Radiofrequency assisted liver partition with portal vein ligation (RALPPS)"
11203722|NCT02216812|BG000|Baseline|500 mg Vitamin C|"Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks~500 mg vitamin c, 1 pill per day for 6 weeks"
11203723|NCT02216812|BG001|Baseline|Placebo|"Arm will take 1 placebo pill per day for 6 weeks~1 placebo pill for 6 weeks"
11203724|NCT02216812|BG002|Baseline|Total|Total of all reporting groups
11203725|NCT02216812|FG000|Participant Flow|500 mg Vitamin C|"Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks~500 mg vitamin c, 1 pill per day for 6 weeks"
11203726|NCT02216812|FG001|Participant Flow|Placebo|"Arm will take 1 placebo pill per day for 6 weeks~1 placebo pill for 6 weeks"
11203727|NCT02216812|OG000|Outcome|500 mg Vitamin C|"Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks~500 mg vitamin c, 1 pill per day for 6 weeks"
11203728|NCT02216812|OG001|Outcome|Placebo|"Arm will take 1 placebo pill per day for 6 weeks~1 placebo pill for 6 weeks"
11203729|NCT02216812|EG000|Reported Event|500 mg Vitamin C|"Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks~500 mg vitamin c, 1 pill per day for 6 weeks"
11203730|NCT02216812|EG001|Reported Event|Placebo|"Arm will take 1 placebo pill per day for 6 weeks~1 placebo pill for 6 weeks"
11203731|NCT02216851|BG000|Baseline|Restylane Perlane|"Single injection of Restylane Perlane in nasal dorsum and/or nasal root~Restylane Perlane: Intradermal injection"
11203732|NCT02216851|BG001|Baseline|No-treatment Control|No-treatment control group do not receive any treatment during the main study period
11203733|NCT02216851|BG002|Baseline|Total|Total of all reporting groups
11203734|NCT02216851|FG000|Participant Flow|Restylane Perlane|"Single injection of Restylane Perlane in nasal dorsum and/or nasal root~Restylane Perlane: Intradermal injection"
11203735|NCT02216851|FG001|Participant Flow|No-treatment Control|No-treatment control group do not receive any treatment during the main study period
10966998|NCT00890929|BG000|Baseline|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
11203736|NCT02216851|OG000|Outcome|Restylane Perlane|"Single injection of Restylane Perlane in nasal dorsum and/or nasal root~Restylane Perlane: Intradermal injection"
10966999|NCT00890929|FG000|Participant Flow|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
10967000|NCT00890929|OG000|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
11203737|NCT02216851|OG001|Outcome|No-treatment Control|No-treatment control group do not receive any treatment during the main study period
11203738|NCT02216851|EG000|Reported Event|Restylane Perlane|"Single injection of Restylane Perlane in nasal dorsum and/or nasal root~Restylane Perlane: Intradermal injection"
11203739|NCT02216851|EG001|Reported Event|No-treatment Control|No-treatment control group do not receive any treatment during the main study period
11203740|NCT02217280|BG000|Baseline|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
11203741|NCT02217280|FG000|Participant Flow|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
11203742|NCT02217280|OG000|Outcome|Injection With Gadolinium|"This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.~Injection with Gadolinium: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system"
11203743|NCT02217280|OG000|Outcome|Cervical ESI|Male and female subjects between the ages of 18-85 with cervical radiculopathy. This was a single arm study.
11203744|NCT02217280|EG000|Reported Event|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
11203745|NCT02217332|BG000|Baseline|Dexpramipexole|"dexpramipexole 150 mg BID~dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)"
11203746|NCT02217332|FG000|Participant Flow|Dexpramipexole|"dexpramipexole 150 mg BID~dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)"
11203747|NCT02217332|OG000|Outcome|Dexpramipexole|"dexpramipexole 150 mg BID~dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)"
11203748|NCT02217332|EG000|Reported Event|Dexpramipexole|"dexpramipexole 150 mg BID~dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)"
11203749|NCT02217410|BG000|Baseline|CFZ533 + TAC + MMF (Part 1)|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203750|NCT02217410|BG001|Baseline|CFZ533 + MMF (Part 2)|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203751|NCT02217410|BG002|Baseline|Tac + MMF (Part 2)|Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]
11203752|NCT02217410|BG003|Baseline|Total|Total of all reporting groups
11203753|NCT02217410|FG000|Participant Flow|CFZ533 + TAC + MMF (Part 1)|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203754|NCT02217410|FG001|Participant Flow|CFZ533 + MMF (Part 2)|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203755|NCT02217410|FG002|Participant Flow|Tac + MMF (Part 2)|Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]
11203756|NCT02217410|OG000|Outcome|CFZ533 + TAC + MMF (Part 1)|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203757|NCT02217410|OG000|Outcome|CFZ533 + MMF (Part 2)|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203758|NCT02217410|OG001|Outcome|Tac + MMF (Part 2)|Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]
11203759|NCT02217410|OG000|Outcome|sCD40 (Part I)|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203760|NCT02217410|OG001|Outcome|sCD154|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203761|NCT02217410|OG000|Outcome|Free CD40 on Whole Blood B Ceels|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203762|NCT02217410|OG001|Outcome|Total CD40 on Whole Blood B Cells|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203763|NCT02217410|EG000|Reported Event|CFZ533 + TAC + MMF (Part 1)|CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
11203764|NCT02217410|EG001|Reported Event|CFZ533 + MMF (Part 2)|CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
11203765|NCT02217410|EG002|Reported Event|Tac + MMF (Part 2)|Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]
10967001|NCT00890929|EG000|Reported Event|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
11203766|NCT02217410|EG003|Reported Event|Total|Total
10967002|NCT00890981|BG000|Baseline|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
10967003|NCT00890981|BG001|Baseline|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
10967004|NCT00890981|BG002|Baseline|Total|Total of all reporting groups
11203767|NCT02217436|BG000|Baseline|iPad|"iPad + Standard Care~iPad: iPad with age-appropriate applications, videos, and music~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203768|NCT02217436|BG001|Baseline|Standard Care|"Standard Care~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203769|NCT02217436|BG002|Baseline|Total|Total of all reporting groups
11203770|NCT02217436|FG000|Participant Flow|iPad|"iPad + Standard Care~iPad: iPad with age-appropriate applications, videos, and music~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203771|NCT02217436|FG001|Participant Flow|Standard Care|"All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203772|NCT02217436|OG000|Outcome|iPad|"iPad + Standard Care~iPad: iPad with age-appropriate applications, videos, and music~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203773|NCT02217436|OG001|Outcome|Standard Care|"Standard Care~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203774|NCT02217436|EG000|Reported Event|iPad|"iPad + Standard Care~iPad: iPad with age-appropriate applications, videos, and music~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203775|NCT02217436|EG001|Reported Event|Standard Care|"Standard Care~Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization)."
11203776|NCT02217475|BG000|Baseline|CVC 150mg/CVC 150 mg|CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
11203777|NCT02217475|BG001|Baseline|Placebo/Cenicriviroc (CVC) 150 mg|Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
11203778|NCT02217475|BG002|Baseline|Placebo/Placebo|Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
11203779|NCT02217475|BG003|Baseline|Total|Total of all reporting groups
11203780|NCT02217475|FG000|Participant Flow|Placebo/Placebo|Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
11203781|NCT02217475|FG001|Participant Flow|Placebo/Cenicriviroc (CVC) 150 mg|Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
11203782|NCT02217475|FG002|Participant Flow|CVC 150mg/CVC 150 mg|CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
11203783|NCT02217475|OG000|Outcome|Placebo|Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
11203784|NCT02217475|OG001|Outcome|CVC 150 mg|Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
11203785|NCT02217475|OG000|Outcome|Placebo|Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
11203786|NCT02217475|OG001|Outcome|CVC 150 mg|Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
11203787|NCT02217475|OG000|Outcome|CVC 150 mg/CVC 150 mg|CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
11203788|NCT02217475|OG001|Outcome|Placebo/CVC 150 mg|Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
11203789|NCT02217475|OG002|Outcome|Placebo/Placebo|Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
11203790|NCT02217475|OG000|Outcome|CVC 150 mg (Year 1)|CVC 150 mg tablet, once daily in the morning with food in Year 1.
11203791|NCT02217475|OG001|Outcome|Placebo (Year 1)|Placebo-matching cenicriviroc tablet once daily in the morning with food in Year 1.
11203792|NCT02217475|OG002|Outcome|CVC 150 mg|Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
11203793|NCT02217475|OG003|Outcome|Placebo Then CVC 150 mg|Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2. Includes AEs that occurred in Year 2.
11203794|NCT02217475|OG004|Outcome|Placebo Then Placebo|Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2. Includes AEs that occurred in Year 2.
11203795|NCT02217475|EG000|Reported Event|CVC 150mg/CVC 150 mg|CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
11203796|NCT02217475|EG001|Reported Event|Placebo/Cenicriviroc (CVC) 150 mg|Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
11203797|NCT02217475|EG002|Reported Event|Placebo/Placebo|Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
11203798|NCT02217501|BG000|Baseline|DAPT - Clinically Indicated Duration+12m|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months"
11203799|NCT02217501|BG001|Baseline|DAPT - Clinically Indicated Duration|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration"
11203800|NCT02217501|BG002|Baseline|Total|Total of all reporting groups
11203801|NCT02217501|FG000|Participant Flow|DAPT - Clinically Indicated Duration+12m|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months"
11203802|NCT02217501|FG001|Participant Flow|DAPT - Clinically Indicated Duration|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration"
11203803|NCT02217501|OG000|Outcome|DAPT - Clinically Indicated Duration+12m|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months"
11203804|NCT02217501|OG001|Outcome|DAPT - Clinically Indicated Duration|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration"
11203805|NCT02217501|EG000|Reported Event|DAPT - Clinically Indicated Duration+12m|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months"
11203806|NCT02217501|EG001|Reported Event|DAPT - Clinically Indicated Duration|"Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days~Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration~Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration"
11243872|NCT02506673|BG000|Baseline|Sedation Only With Skin Conductance Monitor|"Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Midazolam~Skin Conductance Monitor"
11243873|NCT02506673|BG001|Baseline|Sedation & Audiovisual Aids With Skin Conductance Monitor|"Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Zeiss, Cinema ProMED (audiovisual equipment)~Midazolam~Skin Conductance Monitor"
11243874|NCT02506673|BG002|Baseline|Total|Total of all reporting groups
11243875|NCT02506673|FG000|Participant Flow|Sedation Only With Skin Conductance Monitor|"Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Midazolam~Skin Conductance Monitor"
11243876|NCT02506673|FG001|Participant Flow|Sedation & Audiovisual Aids With Skin Conductance Monitor|"Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Zeiss, Cinema ProMED (audiovisual equipment)~Midazolam~Skin Conductance Monitor"
11243877|NCT02506673|OG000|Outcome|Sedation Only With Skin Conductance Monitor|"Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Midazolam~Skin Conductance Monitor"
11243878|NCT02506673|OG001|Outcome|Sedation & Audiovisual Aids With Skin Conductance Monitor|"Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Zeiss, Cinema ProMED (audiovisual equipment)~Midazolam~Skin Conductance Monitor"
11243879|NCT02506673|EG000|Reported Event|Sedation Only With Skin Conductance Monitor|"Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Midazolam~Skin Conductance Monitor"
11243880|NCT02506673|EG001|Reported Event|Sedation & Audiovisual Aids With Skin Conductance Monitor|"Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.~Zeiss, Cinema ProMED (audiovisual equipment)~Midazolam~Skin Conductance Monitor"
11243881|NCT02506816|BG000|Baseline|Olaparib|"Drug exposure has a limited duration 28 (+/- 5) days.~Olaparib: Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day)."
11243882|NCT02506816|FG000|Participant Flow|Olaparib|"Drug exposure has a limited duration 28 (+/- 5) days.~Olaparib: Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day)."
11243883|NCT02506816|OG000|Outcome|Olaparib|"Drug exposure has a limited duration 28 (+/- 5) days.~Olaparib: Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day)."
11243884|NCT02506816|EG000|Reported Event|Olaparib|"Drug exposure has a limited duration 28 (+/- 5) days.~Olaparib: Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day)."
11243885|NCT02506868|BG000|Baseline|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: weekly sc administration of darbepoetin alfa"
11243886|NCT02506868|BG001|Baseline|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: weekly sc administration of darbepoetin alfa"
11243887|NCT02506868|BG002|Baseline|Total|Total of all reporting groups
11243888|NCT02506868|FG000|Participant Flow|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243889|NCT02506868|FG001|Participant Flow|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11203807|NCT02217527|BG000|Baseline|Order 1--JNJ Active Then Plac|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week trying to quit on placebo. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203808|NCT02217527|BG001|Baseline|Order 2--Placebo Then JNJ Active|"Placebo pill used for one week quit attempt, as part of crossover design, then one week trying to quit on active JNJ drug.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203809|NCT02217527|BG002|Baseline|Total|Total of all reporting groups
11203810|NCT02217527|FG000|Participant Flow|Order 1--JNJ Active Then Plac|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, followed by trying to quit for one week on placebo. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203811|NCT02217527|FG001|Participant Flow|Order 2--Placebo Then JNJ Active|"Placebo pill used for one week quit attempt, as part of crossover design, followed by one week of trying to quit on active JNJ drug.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203812|NCT02217527|OG000|Outcome|Order 1--JNJ Active Then Plac|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week quitting on placebo. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203813|NCT02217527|OG001|Outcome|Order 2--Placebo Then JNJ Active|"Placebo pill used for one week quit attempt, as part of crossover design, then one week quitting on active JNJ drug.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.~Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203814|NCT02217527|EG000|Reported Event|While on Active JNJ|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, followed by one week of quitting on placebo. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug used for one week while attempting to briefly quit smoking on Mon-Fri of that week."
11203815|NCT02217527|EG001|Reported Event|While on Placebo|"Placebo pill used for one week quit attempt, as part of crossover design, followed by one week of quitting on active JNJ drug.~Placebo pill: Placebo pill taken daily to assess ability to briefly quit smoking on Mon-Fri for one week."
11203816|NCT02217566|BG000|Baseline|Abiraterone Acetate|Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
11203817|NCT02217566|FG000|Participant Flow|Abiraterone Acetate|Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
11203818|NCT02217566|OG000|Outcome|Abiraterone Acetate|Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
11203819|NCT02217566|EG000|Reported Event|Abiraterone Acetate|Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
10967005|NCT00890981|FG000|Participant Flow|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
11203820|NCT02217618|BG000|Baseline|LY2409021|Single oral dose of 20 mg LY2409021.
11203821|NCT02217618|FG000|Participant Flow|LY2409021|Single oral dose of 20 milligrams (mg) LY2409021.
11203822|NCT02217618|OG000|Outcome|LY2409021|Single oral dose of 20 mg LY2409021.
11203823|NCT02217618|EG000|Reported Event|LY2409021|Single oral dose of 20 mg LY2409021.
11203824|NCT02217800|BG000|Baseline|Saline, Then DG3173, Then Octreotide|Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
11203825|NCT02217800|FG000|Participant Flow|Saline, Then DG3173, Then Octreotide|Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
11203826|NCT02217800|OG000|Outcome|Saline (Control)|
11203827|NCT02217800|OG001|Outcome|920 µg DG3173|
10967006|NCT00890981|FG001|Participant Flow|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
11203828|NCT02217800|OG002|Outcome|2760 µg DG3173|
11203829|NCT02217800|OG003|Outcome|5520 µg DG3173|
11203830|NCT02217800|OG004|Outcome|Active Control (Octreotide)|
11203831|NCT02217800|EG000|Reported Event|Saline (Control)|
11203832|NCT02217800|EG001|Reported Event|920 µg DG3173|
11203833|NCT02217800|EG002|Reported Event|2760 µg DG3173|
11203834|NCT02217800|EG003|Reported Event|5520 µg DG3173|
11203835|NCT02217800|EG004|Reported Event|Active Control (Octreotide)|
11215351|NCT02298842|OG001|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11215352|NCT02298842|OG000|Outcome|Arm A - Test Platelets Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11215353|NCT02298842|OG001|Outcome|Arm B - Platelets Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11215354|NCT02298842|EG000|Reported Event|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11215355|NCT02298842|EG001|Reported Event|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma~Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
11215356|NCT02298868|BG000|Baseline|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
11215357|NCT02298868|FG000|Participant Flow|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
11215358|NCT02298868|OG000|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
11215359|NCT02298868|EG000|Reported Event|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
11215360|NCT02298933|BG000|Baseline|Eculizumab|Eculizumab 1200 mg IV infusion is given over 30-40 min
11215361|NCT02298933|FG000|Participant Flow|Eculizumab|Eculizumab 1200 mg IV infusion is given over 30-40 min
11215362|NCT02298933|OG000|Outcome|Eculizumab|Eculizumab 1200 mg IV infusion is given over 30-40 min
11215363|NCT02298933|EG000|Reported Event|Eculizumab|Eculizumab 1200 mg IV infusion is given over 30-40 min
11215364|NCT02298946|BG000|Baseline|DL1 - CTX, SBRTx1 Day, & AMP-224|"Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
11243890|NCT02506868|OG000|Outcome|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11203836|NCT02217878|BG000|Baseline|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203837|NCT02217878|BG001|Baseline|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203838|NCT02217878|BG002|Baseline|Total|Total of all reporting groups
11203839|NCT02217878|FG000|Participant Flow|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203840|NCT02217878|FG001|Participant Flow|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203841|NCT02217878|OG000|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203842|NCT02217878|OG001|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203843|NCT02217878|EG000|Reported Event|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203844|NCT02217878|EG001|Reported Event|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
11203845|NCT02217904|BG000|Baseline|Panel A: 10 mg Islatravir|Participants received a single dose of 10 mg islatravir.
11203846|NCT02217904|BG001|Baseline|Panel B: 2 mg Islatravir|Participants received a single dose of 2 mg islatravir.
11203847|NCT02217904|BG002|Baseline|Panel C: 30 mg Islatravir|Participants received a single dose of 30 mg islatravir.
11203848|NCT02217904|BG003|Baseline|Panel D: 1 mg Islatravir|Participants received a single dose of 1 mg islatravir.
11203849|NCT02217904|BG004|Baseline|Panel E: 0.5 mg Islatravir|Participants received a single dose of 0.5 mg islatravir.
11203850|NCT02217904|BG005|Baseline|Total|Total of all reporting groups
11203851|NCT02217904|FG000|Participant Flow|Panel A: 10 mg Islatravir|Participants received a single dose of 10 mg islatravir.
11203852|NCT02217904|FG001|Participant Flow|Panel B: 2 mg Islatravir|Participants received a single dose of 2 mg islatravir.
11203853|NCT02217904|FG002|Participant Flow|Panel C: 30 mg Islatravir|Participants received a single dose of 30 mg islatravir.
11203854|NCT02217904|FG003|Participant Flow|Panel D: 1 mg Islatravir|Participants received a single dose of 1 mg islatravir.
11203855|NCT02217904|FG004|Participant Flow|Panel E: 0.5 mg Islatravir|Participants received a single dose of 0.5 mg islatravir.
11203856|NCT02217904|FG005|Participant Flow|Panel F: 0.25 mg Islatravir|Participants received a single does of 0.25 mg islatravir.
11203857|NCT02217904|FG006|Participant Flow|Panel G: 30 mg Islatravir Extended Observation|Participants received a single does of 30 mg islatravir.
11203858|NCT02217904|OG000|Outcome|Panel A: 10 mg Islatravir|Participants received a single dose of 10 mg islatravir.
11203859|NCT02217904|OG001|Outcome|Panel B: 2 mg Islatravir|Participants received a single dose of 2 mg islatravir.
11203860|NCT02217904|OG002|Outcome|Panel C: 30 mg Islatravir|Participants received a single dose of 30 mg islatravir.
11203861|NCT02217904|OG003|Outcome|Panel D: 1 mg Islatravir|Participants received a single dose of 1 mg islatravir.
11203862|NCT02217904|OG004|Outcome|Panel E: 0.5 mg Islatravir|Participants received a single dose of 0.5 mg islatravir.
11203863|NCT02217904|EG000|Reported Event|Panel A: 10 mg Islatravir|Participants received a single dose of 10 mg islatravir.
11203864|NCT02217904|EG001|Reported Event|Panel B: 2 mg Islatravir|Participants received a single dose of 2 mg islatravir.
11203865|NCT02217904|EG002|Reported Event|Panel C: 30 mg Islatravir|Participants received a single dose of 30 mg islatravir.
11203866|NCT02217904|EG003|Reported Event|Panel D: 1 mg Islatravir|Participants received a single dose of 1 mg islatravir.
11203867|NCT02217904|EG004|Reported Event|Panel E: 0.5 mg Islatravir|Participants received a single dose of 0.5 mg islatravir.
11203868|NCT02217982|BG000|Baseline|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
11203869|NCT02217982|BG001|Baseline|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
11203870|NCT02217982|BG002|Baseline|Total|Total of all reporting groups
11203871|NCT02217982|FG000|Participant Flow|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
11203872|NCT02217982|FG001|Participant Flow|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
11203873|NCT02217982|OG000|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
11243891|NCT02506868|OG001|Outcome|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11203874|NCT02217982|OG001|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
11203875|NCT02217982|EG000|Reported Event|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
11203876|NCT02217982|EG001|Reported Event|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
11203877|NCT02218008|BG000|Baseline|Placebo|Randomized to placebo in Stage 1
11203878|NCT02218008|BG001|Baseline|ALKS 5461 1mg/1mg|Randomized to ALKS 5461 1mg/1mg in Stage 1
11203879|NCT02218008|BG002|Baseline|ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 1
11203880|NCT02218008|BG003|Baseline|Total|Total of all reporting groups
11203881|NCT02218008|FG000|Participant Flow|Placebo S1|Randomized to placebo in Stage 1
11203882|NCT02218008|FG001|Participant Flow|ALKS 5461 1mg/1mg S1|Randomized to ALKS 5461 1mg/1mg in Stage 1
11203883|NCT02218008|FG002|Participant Flow|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
11203884|NCT02218008|FG003|Participant Flow|Placebo S2|Randomized to placebo in Stage 2
11203885|NCT02218008|FG004|Participant Flow|ALKS 5461 1mg/1mg S2|Randomized to ALKS 5461 1mg/1mg in Stage 2
11203886|NCT02218008|FG005|Participant Flow|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11203887|NCT02218008|OG000|Outcome|Placebo S1|Randomized to placebo in Stage 1
11203888|NCT02218008|OG001|Outcome|ALKS 5461 1mg/1mg S1|Randomized to ALKS 5461 1mg/1mg in Stage 1
11203889|NCT02218008|OG002|Outcome|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
10967007|NCT00890981|OG000|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
11203890|NCT02218008|OG003|Outcome|Placebo S2|Randomized to placebo in Stage 2
11203891|NCT02218008|OG004|Outcome|ALKS 5461 1mg/1mg S2|Randomized to ALKS 5461 1mg/1mg in Stage 2
11203892|NCT02218008|OG005|Outcome|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11203893|NCT02218008|EG000|Reported Event|Placebo S1|Randomized to placebo in Stage 1
11203894|NCT02218008|EG001|Reported Event|ALKS 5461 1mg/1mg S1|Randomized to ALKS 5461 1mg/1mg in Stage 1
11203895|NCT02218008|EG002|Reported Event|ALKS 5461 2mg/2mg S1|Randomized to ALKS 5461 2mg/2mg in Stage 1
11203896|NCT02218008|EG003|Reported Event|Placebo S2|Randomized to placebo in Stage 2
11203897|NCT02218008|EG004|Reported Event|ALKS 5461 1mg/1mg S2|Randomized to ALKS 5461 1mg/1mg in Stage 2
11203898|NCT02218008|EG005|Reported Event|ALKS 5461 2mg/2mg S2|Randomized to ALKS 5461 2mg/2mg in Stage 2
11203899|NCT02218190|BG000|Baseline|Alvimopan|"Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.~Alvimopan"
11203900|NCT02218190|BG001|Baseline|Placebo - Sugar Pill|"Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven~Placebo"
11203901|NCT02218190|BG002|Baseline|Total|Total of all reporting groups
11203902|NCT02218190|FG000|Participant Flow|Alvimopan|"Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.~Alvimopan"
11203903|NCT02218190|FG001|Participant Flow|Placebo - Sugar Pill|"Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven~Placebo"
11203904|NCT02218190|OG000|Outcome|Alvimopan|"Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.~Alvimopan"
11203905|NCT02218190|OG001|Outcome|Placebo - Sugar Pill|"Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven~Placebo"
11203906|NCT02218190|EG000|Reported Event|Alvimopan|"Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.~Alvimopan"
11203907|NCT02218190|EG001|Reported Event|Placebo - Sugar Pill|"Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven~Placebo"
11203908|NCT02218203|BG000|Baseline|Dextromethorphan/Lidocaine Combination Clinical Trial|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203909|NCT02218203|FG000|Participant Flow|Dextromethorphan/Lidocaine Combination Clinical Trial|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203910|NCT02218203|OG000|Outcome|Dextromethorphan/ 0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 0mg/kg Lidocaine.
11243892|NCT02506868|OG000|Outcome|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks of main period and 28 week of additional period~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243893|NCT02506868|OG001|Outcome|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) or 24 weeks of main period and 28 week of additional period~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243894|NCT02506868|OG000|Outcome|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243895|NCT02506868|OG001|Outcome|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243896|NCT02506868|EG000|Reported Event|BCD-066|"Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243897|NCT02506868|EG001|Reported Event|Aranesp|"Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks~Darbepoetin alfa: Weekly sc administration of darbepoetin alfa"
11243898|NCT02506881|BG000|Baseline|BCD-066 → Aranesp - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
11243899|NCT02506881|BG001|Baseline|Aranesp → BCD-066 - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
11243900|NCT02506881|BG002|Baseline|BCD-066 → Aranesp - Intravenous|Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
11243901|NCT02506881|BG003|Baseline|Aranesp → BCD-066 - Intravenous|Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
11243902|NCT02506881|BG004|Baseline|Total|Total of all reporting groups
11243903|NCT02506881|FG000|Participant Flow|BCD-066 → Aranesp - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
11243904|NCT02506881|FG001|Participant Flow|Aranesp → BCD-066 - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
11243905|NCT02506881|FG002|Participant Flow|BCD-066 → Aranesp - Intravenous|"Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
11243906|NCT02506881|FG003|Participant Flow|Aranesp → BCD-066 - Intravenous|"Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
11243907|NCT02506881|OG000|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
11243908|NCT02506881|OG001|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
11243909|NCT02506881|OG002|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
11243910|NCT02506881|OG003|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
11243911|NCT02506881|OG000|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
11243912|NCT02506881|OG001|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
11243913|NCT02506881|OG002|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
11243914|NCT02506881|OG003|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
11243915|NCT02506881|OG000|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
11243916|NCT02506881|OG001|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
11243917|NCT02506881|OG002|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
11243918|NCT02506881|OG003|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
11243919|NCT02506881|OG000|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
11243920|NCT02506881|OG001|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
11243921|NCT02506881|EG000|Reported Event|BCD-066 Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
11243922|NCT02506881|EG001|Reported Event|Aranesp® Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
11203911|NCT02218203|OG001|Outcome|Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 1mg/kg Lidocaine.
11203912|NCT02218203|OG002|Outcome|Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 2mg/kg Lidocaine.
11203913|NCT02218203|OG003|Outcome|Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 4mg/kg Lidocaine.
11203914|NCT02218203|EG000|Reported Event|Placebo Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203915|NCT02218203|EG001|Reported Event|Placebo Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203916|NCT02218203|EG002|Reported Event|Placebo Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203917|NCT02218203|EG003|Reported Event|Placebo Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203918|NCT02218203|EG004|Reported Event|Low Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203919|NCT02218203|EG005|Reported Event|Low Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203920|NCT02218203|EG006|Reported Event|Low Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203921|NCT02218203|EG007|Reported Event|Low Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203922|NCT02218203|EG008|Reported Event|Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203923|NCT02218203|EG009|Reported Event|Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11215365|NCT02298946|BG001|Baseline|DL2 - CTX, SBRTx3 Days, and AMP-224|"Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
11215366|NCT02298946|BG002|Baseline|Total|Total of all reporting groups
10967008|NCT00890981|OG001|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
10967009|NCT00890981|EG000|Reported Event|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
11203924|NCT02218203|EG010|Reported Event|Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
10967010|NCT00890981|EG001|Reported Event|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
11243923|NCT02506881|EG002|Reported Event|BCD-066 - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
11243924|NCT02506881|EG003|Reported Event|Aranesp® - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
11243925|NCT02507011|BG000|Baseline|All Participants|Crossover Design: All participants pooled at baseline
11243926|NCT02507011|FG000|Participant Flow|Carvedilol First, Then Placebo|Participants in this arm received Carvedilol first
11243927|NCT02507011|FG001|Participant Flow|Placebo First, Then Carvedilol|Participants in this arm received placebo first
11243928|NCT02507011|OG000|Outcome|Carvedilol|"Beta Blocker~Carvedilol: Beta-adrenergic receptor blocker~Placebo: Placebo"
11243929|NCT02507011|OG001|Outcome|Placebo|"General Placebo~Carvedilol: Beta-adrenergic receptor blocker~Placebo: Placebo"
11243930|NCT02507011|EG000|Reported Event|Carvedilol|"Beta Blocker~Carvedilol: Beta-adrenergic receptor blocker~Placebo: Placebo"
11243931|NCT02507011|EG001|Reported Event|Placebo|"General Placebo~Carvedilol: Beta-adrenergic receptor blocker~Placebo: Placebo"
11243932|NCT02507219|BG000|Baseline|All Study Participants|Subjects received either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter-balanced study. Each participant received all interventions. Each study session occurred 1-2 weeks following the previous session. Ibuprofen was capsuled, and identical placebo capsules were produced.
11243933|NCT02507219|FG000|Participant Flow|Placebo, Ibuprofen 200mg, Ibuprofen 600mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 200mg, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243934|NCT02507219|FG001|Participant Flow|Placebo, Ibuprofen, 600mg, Ibuprofen 200mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 600mg, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243935|NCT02507219|FG002|Participant Flow|Ibuprofen, 200mg, Placebo, Ibuprofen 600mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Placebo, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243936|NCT02507219|FG003|Participant Flow|Ibuprofen 200mg, Ibuprofen 600mg, Placebo|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Ibuprofen 600mg, Placebo. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243937|NCT02507219|FG004|Participant Flow|Ibuprofen 600mg, Placebo, Ibuprofen 200mg|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243938|NCT02507219|FG005|Participant Flow|Ibuprofen 600mg, Ibuprofen 200mg, Placebo|Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
11243939|NCT02507219|OG000|Outcome|Placebo|"Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
11243940|NCT02507219|OG001|Outcome|Ibuprofen, 200mg|"Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
11243941|NCT02507219|OG002|Outcome|Ibuprofen, 600mg|"Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
11243942|NCT02507219|EG000|Reported Event|Placebo|"Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
10967011|NCT00891020|BG000|Baseline|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11243943|NCT02507219|EG001|Reported Event|Ibuprofen, 200mg|"Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
11243944|NCT02507219|EG002|Reported Event|Ibuprofen, 600mg|"Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.~Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced."
11243945|NCT02507297|BG000|Baseline|PAP Group|"Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly~Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device."
11243946|NCT02507297|BG001|Baseline|TAU Group|Treatment as usual through obstetrics
11243947|NCT02507297|BG002|Baseline|Total|Total of all reporting groups
11243948|NCT02507297|FG000|Participant Flow|PAP Group|"Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly~Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device."
11243949|NCT02507297|FG001|Participant Flow|TAU Group|Treatment as usual through obstetrics
11243950|NCT02507297|OG000|Outcome|PAP Group|"Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly~Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device."
11243951|NCT02507297|OG001|Outcome|TAU Group|Treatment as usual through obstetrics
11243952|NCT02507297|EG000|Reported Event|PAP Group|"Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly~Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device."
11243953|NCT02507297|EG001|Reported Event|TAU Group|Treatment as usual through obstetrics
11243954|NCT02507349|BG000|Baseline|Person-Centered Care|"Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.~Person-Centered Care: Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visi"
11243955|NCT02507349|BG001|Baseline|Measurement-Based Care|"Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.~Measurement-Based Care: Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient."
11243956|NCT02507349|BG002|Baseline|Total|Total of all reporting groups
11243957|NCT02507349|FG000|Participant Flow|Person-Centered Care|"Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.~Person-Centered Care: Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visi"
11243958|NCT02507349|FG001|Participant Flow|Measurement-Based Care|"Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.~Measurement-Based Care: Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient."
11203925|NCT02218203|EG011|Reported Event|Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203926|NCT02218203|EG012|Reported Event|High Dose Dextromethorphan/0mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203927|NCT02218203|EG013|Reported Event|High Dose Dextromethorphan/1mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203928|NCT02218203|EG014|Reported Event|High Dose Dextromethorphan/2mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203929|NCT02218203|EG015|Reported Event|High Dose Dextromethorphan/4mg/kg Lidocaine Combination|This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
11203930|NCT02218216|BG000|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203931|NCT02218216|BG001|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203932|NCT02218216|BG002|Baseline|Total|Total of all reporting groups
11203933|NCT02218216|FG000|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203934|NCT02218216|FG001|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203935|NCT02218216|FG002|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203936|NCT02218216|OG000|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203937|NCT02218216|OG001|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203938|NCT02218216|OG002|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203939|NCT02218216|EG000|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203940|NCT02218216|EG001|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI~MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203941|NCT02218216|EG002|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration~Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
11203942|NCT02218242|BG000|Baseline|Ultrasound|"Intraoperative ultrasound~Intraoperative ultrasound: Intraoperative ultrasound"
11203943|NCT02218242|FG000|Participant Flow|Ultrasound|"Intraoperative ultrasound~Intraoperative ultrasound: Intraoperative ultrasound"
11203944|NCT02218242|OG000|Outcome|Ultrasound|"Intraoperative ultrasound~Intraoperative ultrasound: Intraoperative ultrasound"
11203945|NCT02218242|EG000|Reported Event|Ultrasound|"Intraoperative ultrasound~Intraoperative ultrasound: Intraoperative ultrasound"
11215367|NCT02298946|FG000|Participant Flow|DL1 - CTX, SBRTx1 Day, & AMP-224|"Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
11203946|NCT02218268|BG000|Baseline|All Participants|This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
11203947|NCT02218268|FG000|Participant Flow|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
11203948|NCT02218268|FG001|Participant Flow|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
11203949|NCT02218268|OG000|Outcome|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
11203950|NCT02218268|OG001|Outcome|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
11203951|NCT02218268|EG000|Reported Event|Pre-meal Bolus Then No Meal Bolus|A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
11203952|NCT02218268|EG001|Reported Event|No Meal Bolus Then Pre-meal Bolus|A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.
11203953|NCT02218307|BG000|Baseline|Mupirocin|"topical antibiotic~Mupirocin"
11203954|NCT02218307|BG001|Baseline|Placebo|"Placebo control for mupirocin~Placebo"
11203955|NCT02218307|BG002|Baseline|Total|Total of all reporting groups
11203956|NCT02218307|FG000|Participant Flow|Mupirocin|"topical antibiotic~Mupirocin"
11203957|NCT02218307|FG001|Participant Flow|Placebo|"Placebo control for mupirocin~Placebo"
11203958|NCT02218307|OG000|Outcome|Mupirocin|"topical antibiotic~Mupirocin"
11203959|NCT02218307|OG001|Outcome|Placebo|"Placebo control for mupirocin~Placebo"
11203960|NCT02218307|EG000|Reported Event|Mupirocin|"topical antibiotic~Mupirocin"
11203961|NCT02218307|EG001|Reported Event|Placebo|"Placebo control for mupirocin~Placebo"
11203962|NCT02218320|BG000|Baseline|Group A|"Ten HIV-infected adults will be in Group A and take the HIV medication raltegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Raltegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples. All 10 subjects underwent a bowel prep with subsequent colonoscopy to obtain tissue samples."
11203963|NCT02218320|BG001|Baseline|Group B|"Ten HIV-infected adults will be in Group B and take the HIV medication dolutegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Dolutegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples. All 10 subjects underwent a bowel prep with subsequent colonoscopy to obtain tissue samples."
11203964|NCT02218320|BG002|Baseline|Total|Total of all reporting groups
11203965|NCT02218320|FG000|Participant Flow|Group A|"Ten HIV-infected adults will be in Group A and take the HIV medication raltegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Raltegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples."
11203966|NCT02218320|FG001|Participant Flow|Group B|"Ten HIV-infected adults will be in Group B and take the HIV medication dolutegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Dolutegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples."
11203967|NCT02218320|OG000|Outcome|Group A|"Ten HIV-infected adults will be in Group A and take the HIV medication raltegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Raltegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples."
11203968|NCT02218320|OG001|Outcome|Group B|"Ten HIV-infected adults will be in Group B and take the HIV medication dolutegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Dolutegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples."
11203969|NCT02218320|EG000|Reported Event|Group A|"Ten HIV-infected adults will be in Group A and take the HIV medication raltegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Raltegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples. All participants underwent a bowel prep with subsequent colonoscopy to obtain tissue samples."
11203970|NCT02218320|EG001|Reported Event|Group B|"Ten HIV-infected adults will be in Group B and take the HIV medication dolutegravir in combination with tenofovir and emtricitabine as their provider-prescribed antiretroviral regimen.~Dolutegravir~Colonoscopy with biopsy: This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples.All participants underwent a bowel prep with subsequent colonoscopy to obtain tissue samples."
11203971|NCT02218372|BG000|Baseline|Fidaxomicin|Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
11203972|NCT02218372|BG001|Baseline|Vancomycin|Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
11203973|NCT02218372|BG002|Baseline|Total|Total of all reporting groups
11203974|NCT02218372|FG000|Participant Flow|Fidaxomicin|Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
11203975|NCT02218372|FG001|Participant Flow|Vancomycin|Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
11203976|NCT02218372|OG000|Outcome|Fidaxomicin|Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
11203977|NCT02218372|OG001|Outcome|Vancomycin|Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
11203978|NCT02218372|OG000|Outcome|Fidaxomin All Formulations|Participants received either fidaxomicin oral suspension or tablet formulation.
11203979|NCT02218372|OG001|Outcome|Fidaxomicin Oral Suspension|Participants received fidaxomicin oral suspension formulation.
11203980|NCT02218372|OG002|Outcome|Fidaxomicin Tablets|Participants received fidaxomicin tablets formulation.
11203981|NCT02218372|OG000|Outcome|Fidaxomicin Oral Suspension|Participants received fidaxomicin oral suspension formulation.
11203982|NCT02218372|OG001|Outcome|Vancomycin Oral Liquid|Participants received vancomycin oral liquid formulation.
11203983|NCT02218372|EG000|Reported Event|Fidaxomicin|Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
11203984|NCT02218372|EG001|Reported Event|Vancomycin|Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
11203985|NCT02218424|BG000|Baseline|Magnesium|"Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.~Magnesium"
11203986|NCT02218424|BG001|Baseline|Placebo Infusion|"Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.~Normal saline"
11203987|NCT02218424|BG002|Baseline|Total|Total of all reporting groups
11203988|NCT02218424|FG000|Participant Flow|Magnesium|"Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.~Magnesium"
11243959|NCT02507349|OG000|Outcome|Person-Centered Care|"Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.~Person-Centered Care: Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visi"
11243960|NCT02507349|OG001|Outcome|Measurement-Based Care|"Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.~Measurement-Based Care: Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient."
11243961|NCT02507349|EG000|Reported Event|Person-Centered Care|Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit. Person-Centered Care: Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
11243962|NCT02507349|EG001|Reported Event|Measurement-Based Care|"Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.~Measurement-Based Care: Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient."
11243963|NCT02507375|BG000|Baseline|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
11243964|NCT02507375|BG001|Baseline|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
11243965|NCT02507375|BG002|Baseline|Total|Total of all reporting groups
11243966|NCT02507375|FG000|Participant Flow|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
11243967|NCT02507375|FG001|Participant Flow|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
11243968|NCT02507375|OG000|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
11243969|NCT02507375|OG001|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
11243970|NCT02507375|OG000|Outcome|Total Population|Erlotinib + pertuzumab
11243971|NCT02507375|OG001|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
11243972|NCT02507375|OG002|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
11286144|NCT02884414|EG000|Reported Event|Cutaneous Stimulation|"Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.~Cutaneous stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject."
10967012|NCT00891020|BG001|Baseline|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11243973|NCT02507375|OG000|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
11243974|NCT02507375|EG000|Reported Event|Cohort 1|Erlotinib 100 mg + pertuzumab 420 mg
11243975|NCT02507375|EG001|Reported Event|Cohort 2|Erlotinib 150 mg + pertuzumab 420 mg
11203989|NCT02218424|FG001|Participant Flow|Placebo Infusion|"Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.~Normal saline"
11203990|NCT02218424|OG000|Outcome|Magnesium|"Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.~Magnesium"
11203991|NCT02218424|OG001|Outcome|Placebo Infusion|"Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.~Normal saline"
11203992|NCT02218424|EG000|Reported Event|Magnesium|"Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.~Magnesium"
11203993|NCT02218424|EG001|Reported Event|Placebo Infusion|"Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.~Normal saline"
11203994|NCT02218463|BG000|Baseline|Cetaphil|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11203995|NCT02218463|BG001|Baseline|Estradiol Cream 0.01%|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11203996|NCT02218463|BG002|Baseline|Total|Total of all reporting groups
11203997|NCT02218463|FG000|Participant Flow|Cetaphil|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11203998|NCT02218463|FG001|Participant Flow|Estradiol Cream 0.01%|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11203999|NCT02218463|OG000|Outcome|Cetaphil|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11204000|NCT02218463|OG001|Outcome|Estradiol Cream 0.01%|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11204001|NCT02218463|EG000|Reported Event|Cetaphil|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11204002|NCT02218463|EG001|Reported Event|Estradiol Cream 0.01%|"Apply a pea-sized amount to the labial adhesion with lateral traction twice daily~Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily"
11204003|NCT02218489|BG000|Baseline|Vehicle|"Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension."
11243976|NCT02507388|BG000|Baseline|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243977|NCT02507388|BG001|Baseline|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243978|NCT02507388|BG002|Baseline|Total|Total of all reporting groups
11215368|NCT02298946|FG001|Participant Flow|DL2 - CTX, SBRTx3 Days, and AMP-224|"Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
10804162|NCT04133519|EG001|Reported Event|MR-1; Muscle Relaxation, Software as a Medical Device - SaMD|"Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)~Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks."
11243979|NCT02507388|FG000|Participant Flow|Brolucizumab 3 mg|Brolucizumab 3 milligrams (mg)/50 microliters (μL) administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243980|NCT02507388|FG001|Participant Flow|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243981|NCT02507388|OG000|Outcome|Brolucizumab 3 mg|Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243982|NCT02507388|OG001|Outcome|Brolucizumab 6 mg|Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
11243983|NCT02507388|EG000|Reported Event|Pre-Treatment|All subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation
11243984|NCT02507388|EG001|Reported Event|Brolucizumab 3 mg|All subjects who received an IVT injection of brolucizumab 3 mg
11243985|NCT02507388|EG002|Reported Event|Brolucizumab 6 mg|All subjects who received an IVT injection of brolucizumab 6 mg
11243986|NCT02507752|BG000|Baseline|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
11243987|NCT02507752|FG000|Participant Flow|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
11243988|NCT02507752|OG000|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
11204004|NCT02218489|BG001|Baseline|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11204005|NCT02218489|BG002|Baseline|Total|Total of all reporting groups
11204006|NCT02218489|FG000|Participant Flow|Vehicle|"Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension."
11243989|NCT02507752|EG000|Reported Event|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10847536|NCT00283712|BG000|Baseline|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
11204007|NCT02218489|FG001|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11286145|NCT02884427|BG000|Baseline|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
11286146|NCT02884427|BG001|Baseline|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
10804163|NCT04118270|BG000|Baseline|AFib 2gether(TM) App|"Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.~Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app."
10804164|NCT04118270|BG001|Baseline|Providers|Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. Baseline measures were not collected for providers.
10804165|NCT04118270|BG002|Baseline|Total|Total of all reporting groups
10804166|NCT04118270|FG000|Participant Flow|AFib 2gether(TM) App|"Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.~Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app."
10804167|NCT04118270|FG001|Participant Flow|Providers|Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy.
10804168|NCT04118270|OG000|Outcome|Patient|Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
10804169|NCT04118270|OG000|Outcome|Provider|Providers who are caring for patients who have a stroke risk of 2 or higher and have an active AF diagnosis.
10804170|NCT04118270|OG000|Outcome|Patient|Patients with a stroke risk score of 2 or greater and an active diagnosis of AF.
10967013|NCT00891020|BG002|Baseline|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967014|NCT00891020|BG003|Baseline|Total|Total of all reporting groups
10967015|NCT00891020|FG000|Participant Flow|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11286147|NCT02884427|BG002|Baseline|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
11286148|NCT02884427|BG003|Baseline|Total|Total of all reporting groups
11204008|NCT02218489|OG000|Outcome|Vehicle|"Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension."
11204009|NCT02218489|OG001|Outcome|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11204010|NCT02218489|OG001|Outcome|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate."
11204011|NCT02218489|EG000|Reported Event|Vehicle|"Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension."
11204012|NCT02218489|EG001|Reported Event|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease~KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11204013|NCT02218541|BG000|Baseline|Abutment Margin 0.5 mm Subgingival|When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
11204014|NCT02218541|BG001|Baseline|Abutment Margin 1.5 mm Subgingival|When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
11204015|NCT02218541|BG002|Baseline|Total|Total of all reporting groups
11204016|NCT02218541|FG000|Participant Flow|Abutment Margin 0.5 mm Subgingival|When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
11204017|NCT02218541|FG001|Participant Flow|Abutment Margin 1.5 mm Subgingival|When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
11204018|NCT02218541|OG000|Outcome|Abutment Margin 0.5 mm Subgingival|When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
11204019|NCT02218541|OG001|Outcome|Abutment Margin 1.5 mm Subgingival|When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
11204020|NCT02218541|OG001|Outcome|Abutment Margin 1.5 mm Subgingival|"When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline~abutment margin 1.5 mm subgingival"
11204021|NCT02218541|EG000|Reported Event|Abutment Margin 0.5 mm Subgingival|When fabricating an abutment to support the crown, the margin will be placed 0.5mm below the gumline abutment margin 0.5 mm subgingival
11204022|NCT02218541|EG001|Reported Event|Abutment Margin 1.5 mm Subgingival|When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
11204023|NCT02218736|BG000|Baseline|CERC-501|"Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks~CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks"
11204024|NCT02218736|BG001|Baseline|Placebo|"Oral daily administration of 10 mg placebo for 8 weeks~placebo: oral dosing of 10 mg placebo daily for 8 weeks"
11204025|NCT02218736|BG002|Baseline|Total|Total of all reporting groups
11204026|NCT02218736|FG000|Participant Flow|CERC-501|"Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks~CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks"
11204027|NCT02218736|FG001|Participant Flow|Placebo|"Oral daily administration of 10 mg placebo for 8 weeks~placebo: oral dosing of 10 mg placebo daily for 8 weeks"
11204028|NCT02218736|OG000|Outcome|CERC-501|"Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks~CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks"
11204029|NCT02218736|OG001|Outcome|Placebo|"Oral daily administration of 10 mg placebo for 8 weeks~placebo: oral dosing of 10 mg placebo daily for 8 weeks"
11204030|NCT02218736|EG000|Reported Event|CERC-501|"Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks~CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks"
11204031|NCT02218736|EG001|Reported Event|Placebo|"Oral daily administration of 10 mg placebo for 8 weeks~placebo: oral dosing of 10 mg placebo daily for 8 weeks"
11204032|NCT02219009|BG000|Baseline|MIND1 System (Cohort 1)|"Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).~Cohort 1 participants were enrolled under the original protocol."
11204033|NCT02219009|BG001|Baseline|MIND 1 System (Cohort 2)|"Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.~Cohort 2 participants were enrolled under protocol amendment 1."
11204034|NCT02219009|BG002|Baseline|Total|Total of all reporting groups
11204035|NCT02219009|FG000|Participant Flow|MIND1 System (Cohort 1)|"Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).~Cohort 1 participants were enrolled under the original protocol."
11204036|NCT02219009|FG001|Participant Flow|MIND 1 System (Cohort 2)|"Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.~Cohort 2 participants were enrolled under protocol amendment 1."
11204037|NCT02219009|OG000|Outcome|MIND1 System (Cohort 1)|"Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).~Cohort 1 participants were enrolled under the original protocol."
11204038|NCT02219009|OG001|Outcome|MIND 1 System (Cohort 2)|"Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.~Cohort 2 participants were enrolled under protocol amendment 1."
11204039|NCT02219009|EG000|Reported Event|MIND1 System (Cohort 1)|"Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).~Cohort 1 participants were enrolled under the original protocol."
11204040|NCT02219009|EG001|Reported Event|MIND 1 System (Cohort 2)|"Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.~Cohort 2 participants were enrolled under protocol amendment 1."
11204041|NCT02219048|BG000|Baseline|Placebo Twice Daily|Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204042|NCT02219048|BG001|Baseline|PF-03715455 680 mcg Twice Daily|Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204043|NCT02219048|BG002|Baseline|Total|Total of all reporting groups
11204044|NCT02219048|FG000|Participant Flow|Placebo Twice Daily|Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204045|NCT02219048|FG001|Participant Flow|PF-03715455 680 mcg Twice Daily|Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204046|NCT02219048|OG000|Outcome|Placebo Twice Daily|Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204047|NCT02219048|OG001|Outcome|PF-03715455 680 mcg Twice Daily|Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204048|NCT02219048|EG000|Reported Event|Placebo Twice Daily|Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204049|NCT02219048|EG001|Reported Event|PF-03715455 680 mcg Twice Daily|Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
11204050|NCT02219087|BG000|Baseline|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
11204051|NCT02219087|BG001|Baseline|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
11204052|NCT02219087|BG002|Baseline|Total|Total of all reporting groups
11204053|NCT02219087|FG000|Participant Flow|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
11204054|NCT02219087|FG001|Participant Flow|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
11204055|NCT02219087|OG000|Outcome|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
11204056|NCT02219087|OG001|Outcome|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
11204057|NCT02219087|EG000|Reported Event|Liposomal Bupivacaine|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.~Liposomal bupivacaine"
11204058|NCT02219087|EG001|Reported Event|Standard of Care|"Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.~ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia"
11204059|NCT02219256|BG000|Baseline|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
11204060|NCT02219256|BG001|Baseline|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
11204061|NCT02219256|BG002|Baseline|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
11204062|NCT02219256|BG003|Baseline|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
11204063|NCT02219256|BG004|Baseline|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
11204064|NCT02219256|BG005|Baseline|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
11204065|NCT02219256|BG006|Baseline|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
11204066|NCT02219256|BG007|Baseline|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
11204067|NCT02219256|BG008|Baseline|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
11204068|NCT02219256|BG009|Baseline|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
11204069|NCT02219256|BG010|Baseline|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
11204070|NCT02219256|BG011|Baseline|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
11204071|NCT02219256|BG012|Baseline|Total|Total of all reporting groups
11204072|NCT02219256|FG000|Participant Flow|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
11204073|NCT02219256|FG001|Participant Flow|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
11204074|NCT02219256|FG002|Participant Flow|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
11204075|NCT02219256|FG003|Participant Flow|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
11204076|NCT02219256|FG004|Participant Flow|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
11204077|NCT02219256|FG005|Participant Flow|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
11204078|NCT02219256|FG006|Participant Flow|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
11204079|NCT02219256|FG007|Participant Flow|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
11204080|NCT02219256|FG008|Participant Flow|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
11204081|NCT02219256|FG009|Participant Flow|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
11204082|NCT02219256|FG010|Participant Flow|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
11204083|NCT02219256|FG011|Participant Flow|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
11204084|NCT02219256|OG000|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
11204085|NCT02219256|OG001|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
11204086|NCT02219256|OG002|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
11204087|NCT02219256|OG003|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
11204088|NCT02219256|OG004|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
11204089|NCT02219256|OG005|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
11204090|NCT02219256|OG006|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
11204091|NCT02219256|OG007|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
11204092|NCT02219256|OG008|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
11204093|NCT02219256|OG009|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
11204094|NCT02219256|OG010|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
11204095|NCT02219256|OG011|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
11204096|NCT02219256|EG000|Reported Event|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
11204097|NCT02219256|EG001|Reported Event|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
11204098|NCT02219256|EG002|Reported Event|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
11204099|NCT02219256|EG003|Reported Event|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
11204100|NCT02219256|EG004|Reported Event|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
11204101|NCT02219256|EG005|Reported Event|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
11204102|NCT02219256|EG006|Reported Event|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
11204103|NCT02219256|EG007|Reported Event|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
11204104|NCT02219256|EG008|Reported Event|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
11204105|NCT02219256|EG009|Reported Event|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
11204106|NCT02219256|EG010|Reported Event|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
11204107|NCT02219256|EG011|Reported Event|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
11215369|NCT02298946|OG000|Outcome|DL1 - CTX, SBRTx1 Day, & AMP-224|"Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
11215370|NCT02298946|OG001|Outcome|DL2 - CTX, SBRTx3 Days, and AMP-224|"Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
11204108|NCT02219282|BG000|Baseline|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
11204109|NCT02219282|BG001|Baseline|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
11204110|NCT02219282|BG002|Baseline|Total|Total of all reporting groups
11204111|NCT02219282|FG000|Participant Flow|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
11204112|NCT02219282|FG001|Participant Flow|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
10967016|NCT00891020|FG001|Participant Flow|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11204113|NCT02219282|OG000|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
11204114|NCT02219282|OG001|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
10967017|NCT00891020|FG002|Participant Flow|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11204115|NCT02219282|OG000|Outcome|Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
11204116|NCT02219282|OG001|Outcome|Edentuolus|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
11204117|NCT02219282|OG000|Outcome|Dentilous Group|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
11204118|NCT02219282|OG001|Outcome|Edentulous Group|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
11204119|NCT02219282|EG000|Reported Event|Group Dentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
11204120|NCT02219282|EG001|Reported Event|Group Edentulous|"Laryngeal Mask Unique insertion~Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
10967018|NCT00891020|OG000|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11204121|NCT02219308|BG000|Baseline|No Paracervical Block (Sham PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives Sham paracervical block with capped needle. Provider then places IUD.~No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.~IUD placement then proceeds"
11204122|NCT02219308|BG001|Baseline|Paracervical Block (PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.~Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.~IUD placement then proceeds"
11204123|NCT02219308|BG002|Baseline|Total|Total of all reporting groups
11243990|NCT02508077|BG000|Baseline|Treatment (Panitumumab and FOLFIRI)|"Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given PO~Panitumumab: Given IV"
11243991|NCT02508077|FG000|Participant Flow|Treatment (Panitumumab and FOLFIRI)|"Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given PO~Panitumumab: Given IV"
11204124|NCT02219308|FG000|Participant Flow|No Paracervical Block (Sham PCB)|Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives Sham paracervical block with capped needle.
11204125|NCT02219308|FG001|Participant Flow|Paracervical Block (PCB)|Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives paracervical block of 18 mL 1% buffered Lidocaine.
11204126|NCT02219308|OG000|Outcome|No Paracervical Block (Sham PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives Sham paracervical block with capped needle. Provider then places IUD.~No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.~IUD placement then proceeds"
11204127|NCT02219308|OG001|Outcome|Paracervical Block (PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.~Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.~IUD placement then proceeds"
11204128|NCT02219308|EG000|Reported Event|No Paracervical Block (Sham PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives Sham paracervical block with capped needle. Provider then places IUD.~No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.~IUD placement then proceeds"
11204129|NCT02219308|EG001|Reported Event|Paracervical Block (PCB)|"Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.~Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.~Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.~IUD placement then proceeds"
11204130|NCT02219321|BG000|Baseline|Lidocaine Infusion|"A continuous intravenous infusion of lidocaine~Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours"
11204131|NCT02219321|BG001|Baseline|Saline Infusion|"A continuous intravenous infusion of saline~Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours"
11204132|NCT02219321|BG002|Baseline|Total|Total of all reporting groups
11204133|NCT02219321|FG000|Participant Flow|Lidocaine Infusion|"A continuous intravenous infusion of lidocaine~Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours"
11204134|NCT02219321|FG001|Participant Flow|Saline Infusion|"A continuous intravenous infusion of saline~Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours"
11204135|NCT02219321|OG000|Outcome|Lidocaine Infusion|"A continuous intravenous infusion of lidocaine~Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours"
11204136|NCT02219321|OG001|Outcome|Saline Infusion|"A continuous intravenous infusion of saline~Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours"
11204137|NCT02219321|EG000|Reported Event|Lidocaine Infusion|"A continuous intravenous infusion of lidocaine~Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours"
11204138|NCT02219321|EG001|Reported Event|Saline Infusion|"A continuous intravenous infusion of saline~Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours"
11204139|NCT02219334|BG000|Baseline|NoseFrida|"If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.~NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning."
11204140|NCT02219334|BG001|Baseline|NeoSucker|The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.
11204141|NCT02219334|BG002|Baseline|Total|Total of all reporting groups
11204142|NCT02219334|FG000|Participant Flow|NoseFrida|"If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.~NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning."
11204143|NCT02219334|FG001|Participant Flow|NeoSucker|The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.
11204144|NCT02219334|OG000|Outcome|NoseFrida|"If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.~NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning."
11204145|NCT02219334|OG001|Outcome|NeoSucker|The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.
11204146|NCT02219334|EG000|Reported Event|NoseFrida|"If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.~NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning."
11204147|NCT02219334|EG001|Reported Event|NeoSucker|The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.
11204148|NCT02219438|BG000|Baseline|Right Side BOLUS and Left Side BASAL|The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
11204149|NCT02219438|BG001|Baseline|Right Side BASAL and Left Side BOLUS|The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
11204150|NCT02219438|BG002|Baseline|Total|Total of all reporting groups
11204151|NCT02219438|FG000|Participant Flow|Right Side Bolus, Left Side Basal|The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
11204152|NCT02219438|FG001|Participant Flow|Right Side Basal, Left Side Bolus|The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
11204153|NCT02219438|OG000|Outcome|BOLUS|The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
11204154|NCT02219438|OG001|Outcome|BASAL|The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
11204155|NCT02219438|OG000|Outcome|BOLUS|"Bilateral adductor canal catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as hourly bolus doses of 8 mL each a total of 8 times: one at time point zero and 1 on the hour for the following 7 hours. For the left catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 8 hours~Bolus: An adductor canal catheter was inserted and ropivacaine 0.2% administered as hourly bolus doses of 8 mL each: one at time point zero and then on the hour for 7 additional doses.~Basal: An adductor canal catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for a total of 8 hours."
11204156|NCT02219438|OG001|Outcome|BASAL|"Bilateral adductor canal catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 8 hours. For the left catheter, the ropivacaine was administered as hourly bolus doses of 8 mL each a total of 8 times: one at time point zero and 1 on the hour for the following 7 hours.~Bolus: An adductor canal catheter was inserted and ropivacaine 0.2% administered as hourly bolus doses of 8 mL each: one at time point zero and then on the hour for 7 additional doses.~Basal: An adductor canal catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for a total of 8 hours."
11204157|NCT02219438|EG000|Reported Event|Bolus|"ropivacaine 0.2% administration as repeated, scheduled (one/h) bolus doses (8 mL) x8 h~ropivacaine"
11204158|NCT02219438|EG001|Reported Event|Basal|"ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x8 h~ropivacaine"
11204159|NCT02219464|BG000|Baseline|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11243992|NCT02508077|OG000|Outcome|Treatment (Panitumumab and FOLFIRI)|"Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given PO~Panitumumab: Given IV"
11243993|NCT02508077|EG000|Reported Event|Treatment (Panitumumab and FOLFIRI)|"Patients receive 6mg/kg panitumumab IV over 30-90 minutes, 180mg/m2 irinotecan hydrochloride IV over 90 minutes, 400mg/m2 leucovorin calcium PO, and 2400mg/m2 fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~Fluorouracil: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given PO~Panitumumab: Given IV"
11243994|NCT02508103|BG000|Baseline|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
11243995|NCT02508103|BG001|Baseline|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Intranasal Oxytocin for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
11243996|NCT02508103|BG002|Baseline|Total|Total of all reporting groups
11243997|NCT02508103|FG000|Participant Flow|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Placebo for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
11243998|NCT02508103|FG001|Participant Flow|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Oxytocin for late luteal phase administration of a subsequent menstrual cycle.~Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
11243999|NCT02508103|OG000|Outcome|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
11244000|NCT02508103|OG001|Outcome|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
11244001|NCT02508103|EG000|Reported Event|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
11244002|NCT02508103|EG001|Reported Event|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
11244003|NCT02508116|BG000|Baseline|CYP2C19 Genotype Guided|"Prospective CYP2C19 genotyping to decide antiplatelet therapy.~CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time"
11244004|NCT02508116|BG001|Baseline|Control Group|Antiplatelet therapy will be decided based on usual care
11244005|NCT02508116|BG002|Baseline|Total|Total of all reporting groups
11244006|NCT02508116|FG000|Participant Flow|CYP2C19 Genotype Guided|"Prospective CYP2C19 genotyping to decide antiplatelet therapy.~CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time"
11244007|NCT02508116|FG001|Participant Flow|Control Group|Antiplatelet therapy will be decided based on usual care
11244008|NCT02508116|OG000|Outcome|CYP2C19 Genotype Guided|"Prospective CYP2C19 genotyping to decide antiplatelet therapy.~CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time"
11244009|NCT02508116|OG001|Outcome|Control Group|Antiplatelet therapy will be decided based on usual care
11244010|NCT02508116|EG000|Reported Event|CYP2C19 Genotype Guided|"Prospective CYP2C19 genotyping to decide antiplatelet therapy.~CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time"
11244011|NCT02508116|EG001|Reported Event|Control Group|Antiplatelet therapy will be decided based on usual care
11244012|NCT02508194|BG000|Baseline|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
11244013|NCT02508194|BG001|Baseline|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
11244014|NCT02508194|BG002|Baseline|Total|Total of all reporting groups
11244015|NCT02508194|FG000|Participant Flow|Placebo + Inactivated Influenza Vaccine (IIV)|Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
11244016|NCT02508194|FG001|Participant Flow|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
11244017|NCT02508194|OG000|Outcome|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
11244018|NCT02508194|OG001|Outcome|MEDI7510 + IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
11244019|NCT02508194|EG000|Reported Event|Placebo + IIV|Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
11244020|NCT02508194|EG001|Reported Event|MEDI7510+IIV|Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
11204160|NCT02219464|BG001|Baseline|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204161|NCT02219464|BG002|Baseline|Total|Total of all reporting groups
11204162|NCT02219464|FG000|Participant Flow|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204163|NCT02219464|FG001|Participant Flow|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204164|NCT02219464|OG000|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204165|NCT02219464|OG001|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204166|NCT02219464|EG000|Reported Event|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204167|NCT02219464|EG001|Reported Event|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
11204168|NCT02219477|BG000|Baseline|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
11204169|NCT02219477|BG001|Baseline|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
11204170|NCT02219477|BG002|Baseline|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
11204171|NCT02219477|BG003|Baseline|Total|Total of all reporting groups
11204172|NCT02219477|FG000|Participant Flow|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
11204173|NCT02219477|FG001|Participant Flow|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
11204174|NCT02219477|FG002|Participant Flow|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
11204175|NCT02219477|OG000|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
11204176|NCT02219477|OG001|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
11204177|NCT02219477|OG000|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
11204178|NCT02219477|OG002|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
11204179|NCT02219477|EG000|Reported Event|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
11204180|NCT02219477|EG001|Reported Event|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
11204181|NCT02219477|EG002|Reported Event|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
11204182|NCT02219503|BG000|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
11204183|NCT02219503|FG000|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
11204184|NCT02219503|OG000|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
11204185|NCT02219503|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
11204186|NCT02219516|BG000|Baseline|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
11204187|NCT02219516|BG001|Baseline|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
11204188|NCT02219516|BG002|Baseline|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
11204189|NCT02219516|BG003|Baseline|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
11204190|NCT02219516|BG004|Baseline|Total|Total of all reporting groups
11204191|NCT02219516|FG000|Participant Flow|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
11204192|NCT02219516|FG001|Participant Flow|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
11204193|NCT02219516|FG002|Participant Flow|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
11204194|NCT02219516|FG003|Participant Flow|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
11204195|NCT02219516|OG000|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
11204196|NCT02219516|OG001|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
11204197|NCT02219516|OG002|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
11204198|NCT02219516|OG003|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
11204199|NCT02219516|EG000|Reported Event|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
11244021|NCT02508207|BG000|Baseline|Placebo|Participants received placebo matched to TEZ/IVA FDC tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 29 days.
11204200|NCT02219516|EG001|Reported Event|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
11204201|NCT02219516|EG002|Reported Event|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
11204202|NCT02219516|EG003|Reported Event|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
11204203|NCT02219685|BG000|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11204204|NCT02219685|BG001|Baseline|Placebo|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11204205|NCT02219685|BG002|Baseline|Total|Total of all reporting groups
11204206|NCT02219685|FG000|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
11204207|NCT02219685|FG001|Participant Flow|Placebo, Followed by Open-Label LDV/SOF|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11204208|NCT02219685|OG000|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
11204209|NCT02219685|OG001|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
11204210|NCT02219685|OG001|Outcome|Open-Label Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
11204211|NCT02219685|EG000|Reported Event|LDV/SOF (Blinded Phase)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11204212|NCT02219685|EG001|Reported Event|Placebo (Blinded Phase)|LDV/SOF placebo tablet once daily for 12 weeks
11204213|NCT02219685|EG002|Reported Event|LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
11204214|NCT02219815|BG000|Baseline|Standard Care|Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
11204215|NCT02219815|BG001|Baseline|Prehab Intervention|"Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.~Prehab Intervention: Pre-operative, structured exercise intervention."
11204216|NCT02219815|BG002|Baseline|Total|Total of all reporting groups
11204217|NCT02219815|FG000|Participant Flow|Standard Care|Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
11204218|NCT02219815|FG001|Participant Flow|Prehab Intervention|"Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.~Prehab Intervention: Pre-operative, structured exercise intervention."
11204219|NCT02219815|OG000|Outcome|Standard Care|Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
11204220|NCT02219815|OG001|Outcome|Prehab Intervention|"Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.~Prehab Intervention: Pre-operative, structured exercise intervention."
10967019|NCT00891020|OG001|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11204221|NCT02219815|EG000|Reported Event|Standard Care|Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
11204222|NCT02219815|EG001|Reported Event|Prehab Intervention|"Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.~Prehab Intervention: Pre-operative, structured exercise intervention."
11204223|NCT02219932|BG000|Baseline|Placebo|Placebo BID for up to 24 weeks
11204224|NCT02219932|BG001|Baseline|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
11204225|NCT02219932|BG002|Baseline|Total|Total of all reporting groups
11204226|NCT02219932|FG000|Participant Flow|Placebo|Placebo twice daily (BID) for up to 24 weeks
11204227|NCT02219932|FG001|Participant Flow|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
11204228|NCT02219932|OG000|Outcome|Placebo|Placebo BID for up to 24 weeks
11204229|NCT02219932|OG001|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
11204230|NCT02219932|EG000|Reported Event|Placebo|Placebo twice daily (BID) for up to 24 weeks
11204231|NCT02219932|EG001|Reported Event|Fampridine 10mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
11204232|NCT02219997|BG000|Baseline|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
11204233|NCT02219997|BG001|Baseline|Clear IOL|Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
11204234|NCT02219997|BG002|Baseline|Total|Total of all reporting groups
11204235|NCT02219997|FG000|Participant Flow|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
11204236|NCT02219997|FG001|Participant Flow|Clear IOL: BLF First, Then Placebo Filter|Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
11204237|NCT02219997|FG002|Participant Flow|Clear IOL: Placebo Filter First, Then BLF|Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
11204238|NCT02219997|OG000|Outcome|AcrySof IQ IOL|ACRYSOF® IQ IOL without filters
11204239|NCT02219997|OG001|Outcome|Clear IOL|Clear IOL without filters
11204240|NCT02219997|OG000|Outcome|Placebo Filter|Clear IOLs with placebo colored clip-on filters
11204241|NCT02219997|OG001|Outcome|Blue Light Filter|Clear IOL with clip-on glasses with blue light filtering properties
11204242|NCT02219997|OG000|Outcome|ACRYSOF IQ IOL + Placebo Filter|ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo
11204243|NCT02219997|OG001|Outcome|Clear IOL + BLF|Clear IOL with clip-on glasses with blue light filtering properties
11204244|NCT02219997|EG000|Reported Event|Pre-treatment|All subjects from time to consent until initiation of experimental testing
11204245|NCT02219997|EG001|Reported Event|AcrySof IQ IOL|All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing
11204246|NCT02219997|EG002|Reported Event|Clear IOL|All subjects implanted with Clear IOLs from time of initiation of experimental testing
11204247|NCT02220205|BG000|Baseline|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
11204248|NCT02220205|BG001|Baseline|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
11204249|NCT02220205|BG002|Baseline|Total|Total of all reporting groups
11204250|NCT02220205|FG000|Participant Flow|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
11204251|NCT02220205|FG001|Participant Flow|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
11204252|NCT02220205|OG000|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
11204253|NCT02220205|OG001|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
11204254|NCT02220205|EG000|Reported Event|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
11204255|NCT02220205|EG001|Reported Event|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
11204256|NCT02220712|BG000|Baseline|OPC-14597 IMD|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204257|NCT02220712|FG000|Participant Flow|OPC-14597 IMD|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204258|NCT02220712|OG000|Outcome|OPC-14597 IMD (First Dose)|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204259|NCT02220712|OG001|Outcome|OPC-14597 IMD (Second Dose)|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204260|NCT02220712|OG002|Outcome|OPC-14597 IMD (Third Dose)|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204261|NCT02220712|OG003|Outcome|OPC-14597 IMD (Fourth Dose)|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204262|NCT02220712|OG004|Outcome|OPC-14597 IMD (Fifth|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204263|NCT02220712|EG000|Reported Event|OPC-14597 IMD|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
11204264|NCT02220725|BG000|Baseline|Placebo (Part I)|Vehicle Control
11204265|NCT02220725|BG001|Baseline|Andexanet (Part I)|800 mg bolus
11204266|NCT02220725|BG002|Baseline|Placebo (Part II)|Vehicle Control
11204267|NCT02220725|BG003|Baseline|Andexanet (Part II)|800 mg bolus + 960 mg infusion (8 mg/min)
11204268|NCT02220725|BG004|Baseline|Total|Total of all reporting groups
11204269|NCT02220725|FG000|Participant Flow|Placebo (Part I)|Vehicle Control
11204270|NCT02220725|FG001|Participant Flow|Andexanet (Part I)|800 mg bolus
11204271|NCT02220725|FG002|Participant Flow|Placebo (Part II)|Vehicle Control
11204272|NCT02220725|FG003|Participant Flow|Andexanet (Part II)|800 mg bolus + 960 mg infusion (8 mg/min)
11204273|NCT02220725|OG000|Outcome|Placebo (Part I)|Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban)
11204274|NCT02220725|OG001|Outcome|Andexanet (Part I)|Andexanet administered IV as a bolus of 800 mg at a target rate of approximately 30 mg/minute (over approximately 27 minutes) (Part 1). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban)
11204275|NCT02220725|OG002|Outcome|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban)
11204276|NCT02220725|OG003|Outcome|Andexanet (Part II)|Andexanet was administered IV as a bolus of 800 mg at a target rate of approximately 30 mg/minute (over approximately 27 minutes) followed by a continuous infusion of 960 mg at 8 mg/minute for 120 minutes (Part II). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban).
11204277|NCT02220725|OG000|Outcome|Placebo (Part II)|Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban)
11204278|NCT02220725|OG001|Outcome|Andexanet (Part II)|Andexanet was administered IV as a bolus of 800 mg at a target rate of approximately 30 mg/minute (over approximately 27 minutes) followed by a continuous infusion of 960 mg at 8 mg/minute for 120 minutes (Part II). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban).
11204279|NCT02220725|OG001|Outcome|Andexanet (Part I)|Andexanet was administered IV as a bolus of 800 mg at a target rate of approximately 30 mg/minute (over approximately 27 minutes) (Part 1). The bolus was started 4 hours after the last rivaroxaban dose (at the approximate steady state Cmax for rivaroxaban)
11204280|NCT02220725|EG000|Reported Event|Placebo (Part I)|Vehicle Control
11204281|NCT02220725|EG001|Reported Event|Andexanet (Part I)|800 mg bolus
11204282|NCT02220725|EG002|Reported Event|Placebo (Part II)|Vehicle Control
11204283|NCT02220725|EG003|Reported Event|Andexanet (Part II)|800 mg bolus + 960 mg infusion (8 mg/min)
11204284|NCT02220764|BG000|Baseline|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
11204285|NCT02220764|BG001|Baseline|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
11204286|NCT02220764|BG002|Baseline|Total|Total of all reporting groups
11204287|NCT02220764|FG000|Participant Flow|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
11204288|NCT02220764|FG001|Participant Flow|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
11204289|NCT02220764|OG000|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
11204290|NCT02220764|OG001|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
11204291|NCT02220764|EG000|Reported Event|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
11204292|NCT02220764|EG001|Reported Event|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
11204293|NCT02220907|BG000|Baseline|Teneligliptin+Canagliflozin|Teneligliptin and Canagliflozin once daily for 52 weeks.
11204294|NCT02220907|FG000|Participant Flow|Teneligliptin+Canagliflozin|Teneligliptin and Canagliflozin once daily for 52 weeks.
11204295|NCT02220907|OG000|Outcome|Teneligliptin+Canagliflozin|Teneligliptin and Canagliflozin once daily for 52 weeks.
11204296|NCT02220907|EG000|Reported Event|Teneligliptin+Canagliflozin|Teneligliptin and Canagliflozin once daily for 52 weeks.
11204297|NCT02220920|BG000|Baseline|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
11204298|NCT02220920|BG001|Baseline|Placebo＋Insulin|Placebo, once daily for 16 weeks
11204299|NCT02220920|BG002|Baseline|Total|Total of all reporting groups
11204300|NCT02220920|FG000|Participant Flow|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
11204301|NCT02220920|FG001|Participant Flow|Placebo＋Insulin|Placebo, once daily for 16 weeks
11204302|NCT02220920|OG000|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
11204303|NCT02220920|OG001|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
11204304|NCT02220920|EG000|Reported Event|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
11204305|NCT02220920|EG001|Reported Event|Placebo＋Insulin|Placebo, once daily for 16 weeks
11204306|NCT02220998|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11204307|NCT02220998|BG001|Baseline|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11204308|NCT02220998|BG002|Baseline|Total|Total of all reporting groups
11204309|NCT02220998|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
11204310|NCT02220998|FG001|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11204311|NCT02220998|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11204312|NCT02220998|OG001|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11204313|NCT02220998|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
11204314|NCT02220998|EG001|Reported Event|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11204315|NCT02221219|BG000|Baseline|Immediate Cord Clamp & Placebo IV Solution|"This Arm will receive immediate clamp of umbilical cord at birth, and an intravenous delivery of placebo drug solution (diluent for active drug, indomethacin) within the first 12hrs of life.~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204316|NCT02221219|BG001|Baseline|Delay Cord Clamp & Placebo IV Solution|"A delay in cord clamp for 45 seconds will be instituted in the delivery room. Placebo drug solution will be administered within 12hrs post-birth.~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)"
11244022|NCT02508207|BG001|Baseline|TEZ/IVA|Participants received 100 mg TEZ/150 mg IVA FDC tablet orally once daily in the morning followed by 150 mg IVA tablet orally once daily in the evening for 29 days.
11244023|NCT02508207|BG002|Baseline|Total|Total of all reporting groups
11244024|NCT02508207|FG000|Participant Flow|Placebo|Participants received placebo matched to tezacaftor (TEZ)/ivacaftor (IVA) fixed dose combination (FDC) tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 29 days.
10804171|NCT04118270|OG000|Outcome|AFib 2gether(TM) App|"Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.~Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app."
10804172|NCT04118270|EG000|Reported Event|AFib 2gether(TM) App|"Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.~Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app."
10804173|NCT04118270|EG001|Reported Event|Providers|Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy.
10804174|NCT04098367|BG000|Baseline|VIVITY|VIVITY IOL implanted in the eye during cataract surgery
10804175|NCT04098367|BG001|Baseline|SYMFONY|SYMFONY IOL implanted in the eye during cataract surgery
10804176|NCT04098367|BG002|Baseline|AT LARA|AT LARA implanted in the eye during cataract surgery
10804177|NCT04098367|BG003|Baseline|Total|Total of all reporting groups
10804178|NCT04098367|FG000|Participant Flow|VIVITY|VIVITY IOL implanted in the eye during cataract surgery
10804179|NCT04098367|FG001|Participant Flow|SYMFONY|SYMFONY IOL implanted in the eye during cataract surgery
10804180|NCT04098367|FG002|Participant Flow|AT LARA|AT LARA implanted in the eye during cataract surgery
10804181|NCT04098367|OG000|Outcome|VIVITY|VIVITY IOL implanted in the eye during cataract surgery
10804182|NCT04098367|OG001|Outcome|SYMFONY|SYMFONY IOL implanted in the eye during cataract surgery
10804183|NCT04098367|OG002|Outcome|AT LARA|AT LARA implanted in the eye during cataract surgery
10804184|NCT04098367|EG000|Reported Event|Pretreatment|All subjects prior to with attempted implantation with any IOL (successful or aborted implant)
10804185|NCT04098367|EG001|Reported Event|VIVITY First Eye|All eyes that had contact with the VIVITY IOL (successful or aborted implant)
10804186|NCT04098367|EG002|Reported Event|VIVITY Second Eye|All eyes that had contact with the VIVITY IOL (successful or aborted implant)
10804187|NCT04098367|EG003|Reported Event|VIVITY Systemic|All subjects that had contact with the VIVITY IOL (successful or aborted implant)
10804188|NCT04098367|EG004|Reported Event|SYMFONY First Eye|All eyes that had contact with the SYMFONY IOL (successful or aborted implant)
10804189|NCT04098367|EG005|Reported Event|SYMFONY Second Eye|All eyes that had contact with the SYMFONY IOL (successful or aborted implant)
10804190|NCT04098367|EG006|Reported Event|SYMFONY Systemic|All subjects that had contact with the SYMFONY IOL (successful or aborted implant)
10804191|NCT04098367|EG007|Reported Event|AT LARA First Eye|All eyes that had contact with the AT LARA IOL (successful or aborted implant)
10804192|NCT04098367|EG008|Reported Event|AT LARA Second Eye|All eyes that had contact with the AT LARA IOL (successful or aborted implant)
10804193|NCT04098367|EG009|Reported Event|AT LARA Systemic|All subjects that had contact with the AT LARA IOL (successful or aborted implant)
10804194|NCT04091087|BG000|Baseline|Vehicle Ointment|Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804195|NCT04091087|BG001|Baseline|Crisaborole 2% Ointment|Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
11244025|NCT02508207|FG001|Participant Flow|TEZ/IVA|Participants received 100 milligram (mg) TEZ/150 mg IVA FDC tablet orally once daily in the morning followed by 150 mg IVA tablet orally once daily in the evening for 29 days.
11244026|NCT02508207|OG000|Outcome|Placebo|Participants received placebo matched to TEZ/IVA FDC tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 29 days.
10804196|NCT04091087|BG002|Baseline|Total|Total of all reporting groups
10804197|NCT04091087|FG000|Participant Flow|Vehicle Ointment|Participants applied vehicle ointment topically twice a day (BID) to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804198|NCT04091087|FG001|Participant Flow|Crisaborole 2% Ointment|Participants applied crisaborole ointment 2 percent (%) topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804199|NCT04091087|OG000|Outcome|Vehicle Ointment|Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804200|NCT04091087|OG001|Outcome|Crisaborole 2% Ointment|Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804201|NCT04091087|EG000|Reported Event|Vehicle Ointment|Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10804202|NCT04091087|EG001|Reported Event|Crisaborole 2% Ointment|Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
10820457|NCT00058058|FG000|Participant Flow|MRI Evaluation of Contralateral Breast|"The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.~MRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study."
10804203|NCT04009629|BG000|Baseline|APOE4 Carriers|Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
11204317|NCT02221219|BG002|Baseline|Immediate Cord Clamp & Indomethacin IV|"Umbilical cord will be clamped immediately at birth. Indomethacin will be administered IV, starting within 12hrs of life (0.1mg/kg every 24 hrs for three total doses.This intervention is considered 'standard care' at many Neonatology medical facilities. The dose of indomethacin has been shown to be effective in reducing brain bleeds in preterm infants (although there are also data showing safety concerns).~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204318|NCT02221219|BG003|Baseline|Indomethacin iv & Delayed Cord Clamp|"A delay in cord clamp of 45 seconds will be instituted in the delivery room. In addition, indomethacin will be administered iv (initiated within 12hrs of life), 0.1mg/kg every 24 hrs for three total doses.~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)"
11204319|NCT02221219|BG004|Baseline|Total|Total of all reporting groups
11204320|NCT02221219|FG000|Participant Flow|Immediate Cord Clamp & Placebo IV Solution|"This Arm will receive immediate clamp of umbilical cord at birth, and an intravenous delivery of placebo drug solution (diluent for active drug, indomethacin) within the first 12hrs of life.~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204321|NCT02221219|FG001|Participant Flow|Delay Cord Clamp & Placebo IV Solution|"A delay in cord clamp for 45 seconds will be instituted in the delivery room. Placebo drug solution will be administered within 12hrs post-birth.~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)"
11204322|NCT02221219|FG002|Participant Flow|Immediate Cord Clamp & Indomethacin IV|"Umbilical cord will be clamped immediately at birth. Indomethacin will be administered IV, starting within 12hrs of life (0.1mg/kg every 24 hrs for three total doses.This intervention is considered 'standard care' at many Neonatology medical facilities. The dose of indomethacin has been shown to be effective in reducing brain bleeds in preterm infants (although there are also data showing safety concerns).~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204323|NCT02221219|FG003|Participant Flow|Indomethacin iv & Delayed Cord Clamp|"A delay in cord clamp of 45 seconds will be instituted in the delivery room. In addition, indomethacin will be administered iv (initiated within 12hrs of life), 0.1mg/kg every 24 hrs for three total doses.~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)"
11204324|NCT02221219|OG000|Outcome|Immediate Cord Clamp & Placebo IV Solution|"This Arm will receive immediate clamp of umbilical cord at birth, and an intravenous delivery of placebo drug solution (diluent for active drug, indomethacin) within the first 12hrs of life.~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204325|NCT02221219|OG001|Outcome|Delay Cord Clamp & Placebo IV Solution|"A delay in cord clamp for 45 seconds will be instituted in the delivery room. Placebo drug solution will be administered within 12hrs post-birth.~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)"
11204326|NCT02221219|OG002|Outcome|Immediate Cord Clamp & Indomethacin IV|"Umbilical cord will be clamped immediately at birth. Indomethacin will be administered IV, starting within 12hrs of life (0.1mg/kg every 24 hrs for three total doses.This intervention is considered 'standard care' at many Neonatology medical facilities. The dose of indomethacin has been shown to be effective in reducing brain bleeds in preterm infants (although there are also data showing safety concerns).~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204327|NCT02221219|OG003|Outcome|Indomethacin iv & Delayed Cord Clamp|"A delay in cord clamp of 45 seconds will be instituted in the delivery room. In addition, indomethacin will be administered iv (initiated within 12hrs of life), 0.1mg/kg every 24 hrs for three total doses.~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)"
11204328|NCT02221219|EG000|Reported Event|Immediate Cord Clamp & Placebo IV Solution|"This Arm will receive immediate clamp of umbilical cord at birth, and an intravenous delivery of placebo drug solution (diluent for active drug, indomethacin) within the first 12hrs of life.~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
11204329|NCT02221219|EG001|Reported Event|Delay Cord Clamp & Placebo IV Solution|"A delay in cord clamp for 45 seconds will be instituted in the delivery room. Placebo drug solution will be administered within 12hrs post-birth.~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)~placebo infusion: saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)"
11204330|NCT02221219|EG002|Reported Event|Immediate Cord Clamp & Indomethacin IV|"Umbilical cord will be clamped immediately at birth. Indomethacin will be administered IV, starting within 12hrs of life (0.1mg/kg every 24 hrs for three total doses.This intervention is considered 'standard care' at many Neonatology medical facilities. The dose of indomethacin has been shown to be effective in reducing brain bleeds in preterm infants (although there are also data showing safety concerns).~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~immediate cord clamp at birth: no delay in umbilical cord clamp; <10sec (recorded in delivery note)"
10804204|NCT04009629|BG001|Baseline|APOE4 Non-carriers|Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804205|NCT04009629|BG002|Baseline|Total|Total of all reporting groups
10804206|NCT04009629|FG000|Participant Flow|APOE4 Carrier|Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804207|NCT04009629|FG001|Participant Flow|APOE4 Non-carrier|Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804208|NCT04009629|OG000|Outcome|APOE4 Carrier|Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804209|NCT04009629|OG001|Outcome|APOE4 Non-carrier|Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804210|NCT04009629|OG001|Outcome|APOE4 Non-carrier|Participants having zero copies of the APOE4 allele, the strongest late-onset genetic risk factor for Alzheimer's dementia.
10804211|NCT04009629|OG000|Outcome|APOE4 Carrier|Participants with 1 or 2 copies of the ApoE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804212|NCT04009629|OG001|Outcome|APOE4 Non-carrier|Participants having zero copies of the ApoE4 allele, the strongest late-onset genetic risk factor for Alzheimer's dementia.
10804213|NCT04009629|EG000|Reported Event|APOE4 Carrier|Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
10804214|NCT04009629|EG001|Reported Event|APOE4 Non-carrier|Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
11204331|NCT02221219|EG003|Reported Event|Indomethacin iv & Delayed Cord Clamp|"A delay in cord clamp of 45 seconds will be instituted in the delivery room. In addition, indomethacin will be administered iv (initiated within 12hrs of life), 0.1mg/kg every 24 hrs for three total doses.~Indomethacin: indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants~delay in umbilical cord clamp at birth: provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)"
11204332|NCT02221284|BG000|Baseline|Alogliptin + Insulin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204333|NCT02221284|BG001|Baseline|Alogliptin + Glinide|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
10804215|NCT03937908|BG000|Baseline|All Participants|Baseline values for all participants before randomization
10804216|NCT03937908|FG000|Participant Flow|Experimental: 2g CAP Then 4g CAP|Participants first received one single administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach. After a washout period of 14 days, they then received one single administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
10804217|NCT03937908|FG001|Participant Flow|Experimental: 4g CAP Then 2g CAP|Participants first received one single administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach. After a washout period of 14 days, they then received one single administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
10804218|NCT03937908|OG000|Outcome|2g CAP|"Single administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.~2g Centella asiatica water extract product: 2g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach."
10804219|NCT03937908|OG001|Outcome|4g CAP|"Single administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.~4g Centella asiatica water extract product: 4g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach."
10804220|NCT03937908|EG000|Reported Event|2g CAP|Single administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
10804221|NCT03937908|EG001|Reported Event|4g CAP|Single administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
10820458|NCT00058058|OG000|Outcome|Reference Standard Positive (RS+)|Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.
11244027|NCT02508207|OG001|Outcome|TEZ/IVA|Participants received 100 mg TEZ/150 mg IVA FDC tablet orally once daily in the morning followed by 150 mg IVA tablet orally once daily in the evening for 29 days.
11244028|NCT02508207|EG000|Reported Event|Placebo|Participants received placebo matched to TEZ/IVA FDC tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 29 days.
11244029|NCT02508207|EG001|Reported Event|TEZ/IVA|Participants received 100 mg TEZ/150 mg IVA FDC tablet orally once daily in the morning followed by 150 mg IVA tablet orally once daily in the evening for 29 days.
11244030|NCT02508259|BG000|Baseline|Suramin|20 mg/kg IV x 1
11244031|NCT02508259|BG001|Baseline|Saline (Placebo)|IV infusion x 1
11244032|NCT02508259|BG002|Baseline|Total|Total of all reporting groups
11244033|NCT02508259|FG000|Participant Flow|Suramin|20 mg/kg IV x1
11244034|NCT02508259|FG001|Participant Flow|Saline (Placebo)|IV Infusion x 1
11244035|NCT02508259|OG000|Outcome|Suramin|20 mg/kg IV x 1
11244036|NCT02508259|OG001|Outcome|Saline (Placebo)|IV Infusion
11244037|NCT02508259|EG000|Reported Event|Suramin|20 mg/kg IV x 1
11244038|NCT02508259|EG001|Reported Event|Saline (Placebo)|IV Infusion x 1
11244039|NCT02508389|BG000|Baseline|Low Dose GC4419: 30mg/Day|"30 mg GC4419/day prior to IMRT~Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244040|NCT02508389|BG001|Baseline|High Dose GC4419: 90mg/Day|"90 mg GC4419/day prior to IMRT~High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244041|NCT02508389|BG002|Baseline|Placebo|"Placebo daily, prior to IMRT~Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244042|NCT02508389|BG003|Baseline|Total|Total of all reporting groups
11244043|NCT02508389|FG000|Participant Flow|Low Dose GC4419: 30mg/Day|"30 mg GC4419/day prior to IMRT~Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244044|NCT02508389|FG001|Participant Flow|High Dose GC4419: 90mg/Day|"90 mg GC4419/day prior to IMRT~High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244045|NCT02508389|FG002|Participant Flow|Placebo|"Placebo daily, prior to IMRT~Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11286149|NCT02884427|FG000|Participant Flow|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
11204334|NCT02221284|BG002|Baseline|Alogliptin + SGLT-2 Inhibitor|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204335|NCT02221284|BG003|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204336|NCT02221284|BG004|Baseline|Total|Total of all reporting groups
11204337|NCT02221284|FG000|Participant Flow|Overall Population|Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
11204338|NCT02221284|OG000|Outcome|Alogliptin + Insulin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204339|NCT02221284|OG001|Outcome|Alogliptin + Glinide|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204340|NCT02221284|OG002|Outcome|Alogliptin + SGLT-2 Inhibitor|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204341|NCT02221284|OG003|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204342|NCT02221284|EG000|Reported Event|Alogliptin + Insulin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204343|NCT02221284|EG001|Reported Event|Alogliptin + Glinide|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204344|NCT02221284|EG002|Reported Event|Alogliptin + SGLT-2 Inhibit|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204345|NCT02221284|EG003|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.
11204346|NCT02221349|BG000|Baseline|Oxalate Liquid & Gel Plus SnF2 Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Stannous fluoride paste: Toothpaste used by subject"
11204347|NCT02221349|BG001|Baseline|Oxalate Liquid & Gel Plus NaF Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Sodium fluoride paste: Toothpaste used by subject"
11204348|NCT02221349|BG002|Baseline|Total|Total of all reporting groups
11204349|NCT02221349|FG000|Participant Flow|Oxalate Liquid & Gel Plus SnF2 Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Stannous fluoride paste: Toothpaste used by subject"
11204350|NCT02221349|FG001|Participant Flow|Oxalate Liquid & Gel Plus NaF Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Sodium fluoride paste: Toothpaste used by subject"
11204351|NCT02221349|OG000|Outcome|Oxalate Liquid & Gel Plus SnF2 Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Stannous fluoride paste: Toothpaste used by subject"
11204352|NCT02221349|OG001|Outcome|Oxalate Liquid & Gel Plus NaF Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Sodium fluoride paste: Toothpaste used by subject"
11204353|NCT02221349|EG000|Reported Event|Oxalate Liquid & Gel Plus SnF2 Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Stannous fluoride paste: Toothpaste used by subject"
11204354|NCT02221349|EG001|Reported Event|Oxalate Liquid & Gel Plus NaF Paste|"Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied~Potassium oxalate: Professionally applied (liquid) and self applied (gel)~Sodium fluoride paste: Toothpaste used by subject"
11204355|NCT02221557|BG000|Baseline|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
11204356|NCT02221557|FG000|Participant Flow|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
11204357|NCT02221557|OG000|Outcome|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
11204358|NCT02221557|EG000|Reported Event|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
11204359|NCT02221648|BG000|Baseline|Placebo|Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
10804222|NCT03891264|BG000|Baseline|CBD Arm|"Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.~Cannabidiol: Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week."
10804223|NCT03891264|FG000|Participant Flow|CBD Arm|"Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.~Cannabidiol: Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week."
10804224|NCT03891264|OG000|Outcome|CBD Arm|"Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.~Cannabidiol: Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week."
10804225|NCT03891264|EG000|Reported Event|CBD Arm|"Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 4-week trial of a liquid formulation of CBD.~Cannabidiol: Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week."
10804226|NCT03839082|BG000|Baseline|FitBit Then Usual Care|"Intervention includes education, physical activity, and a nutrition assessment.~FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.~Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device)."
10804227|NCT03839082|BG001|Baseline|Usual Care Then FitBit|"This is the waitlist control arm.~Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).~Once they start FitBit, intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done."
10804228|NCT03839082|BG002|Baseline|Total|Total of all reporting groups
10804229|NCT03839082|FG000|Participant Flow|FitBit Then Usual Care|"Intervention includes education, physical activity, and a nutrition assessment.~Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).~FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done."
10804230|NCT03839082|FG001|Participant Flow|Usual Care Then FitBit|"This is the waitlist control arm.~Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).~Once they start FitBit,, Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done."
10804231|NCT03839082|OG000|Outcome|FitBit|"Intervention includes education, physical activity, and a nutrition assessment.~FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done."
10804232|NCT03839082|OG001|Outcome|Usual Care|"This is the waitlist control arm.~Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device)."
10804233|NCT03839082|EG000|Reported Event|FitBit|"Intervention includes education, physical activity, and a nutrition assessment.~FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done."
10804234|NCT03839082|EG001|Reported Event|Usual Care|Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
11204360|NCT02221648|BG001|Baseline|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
11204361|NCT02221648|BG002|Baseline|Total|Total of all reporting groups
10804235|NCT03835351|BG000|Baseline|Intraoperative Urinary Catheter|"After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.~Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case"
10804236|NCT03835351|BG001|Baseline|No Intraoperative Urinary Catheter|No intraoperative urinary catheter will be used during the case
10804237|NCT03835351|BG002|Baseline|Total|Total of all reporting groups
10804238|NCT03835351|FG000|Participant Flow|Intraoperative Urinary Catheter|"After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.~Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case"
10804239|NCT03835351|FG001|Participant Flow|No Intraoperative Urinary Catheter|No intraoperative urinary catheter will be used during the case
11204362|NCT02221648|FG000|Participant Flow|Placebo|Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
11244046|NCT02508389|OG000|Outcome|Low Dose GC4419: 30mg/Day|"30 mg GC4419/day prior to IMRT~Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244047|NCT02508389|OG001|Outcome|High Dose GC4419: 90mg/Day|"90 mg GC4419/day prior to IMRT~High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244048|NCT02508389|OG002|Outcome|Placebo|"Placebo daily, prior to IMRT~Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244049|NCT02508389|EG000|Reported Event|Low Dose GC4419: 30mg/Day|"30 mg GC4419/day prior to IMRT~Low Dose GC4419: 30mg/day: Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244050|NCT02508389|EG001|Reported Event|High Dose GC4419: 90mg/Day|"90 mg GC4419/day prior to IMRT~High Dose GC4419: 90mg/day: High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244051|NCT02508389|EG002|Reported Event|Placebo|"Placebo daily, prior to IMRT~Placebo: Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).~Intensity-Modulated Radiation Therapy: Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks~Cisplatin: Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
11244052|NCT02508428|BG000|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement using a crosslinked Marathon polyethylene liner
11244053|NCT02508428|BG001|Baseline|Non-crosslinked Enduron Polyethylene|Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
11244054|NCT02508428|BG002|Baseline|Total|Total of all reporting groups
11244055|NCT02508428|FG000|Participant Flow|Crosslinked Marathon Polyethylene|Total Hip Replacement using a crosslinked Marathon polyethylene liner
11244056|NCT02508428|FG001|Participant Flow|Standard Enduron Polyethylene|Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
11244057|NCT02508428|OG000|Outcome|Crosslinked Marathon Polyethylene|Total Hip Replacement using a crosslinked Marathon polyethylene liner
11244058|NCT02508428|OG001|Outcome|Non-crosslinked Enduron Polyethylene|Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
11244059|NCT02508428|EG000|Reported Event|Crosslinked Marathon Polyethylene|Total Hip Replacement using a crosslinked Marathon polyethylene liner
11244060|NCT02508428|EG001|Reported Event|Non-crosslinked Enduron Polyethylene|Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
11244061|NCT02508480|BG000|Baseline|Photovoice|"Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format.~Photovoice: The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness.~In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination."
11244062|NCT02508480|BG001|Baseline|Enhanced Control|"Participants in this arm will attend a 60-minute peer-led group discussion on stigma and discrimination, and be eligible to participate in the 10-week Photovoice program after completing all study assessments.~Enhanced Control: The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session. It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month fo"
11244063|NCT02508480|BG002|Baseline|Total|Total of all reporting groups
11244064|NCT02508480|FG000|Participant Flow|Photovoice|"Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format.~Photovoice: The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness.~In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination."
11244065|NCT02508480|FG001|Participant Flow|Enhanced Control|"Participants in this arm will attend a 60-minute peer-led group discussion on stigma and discrimination, and be eligible to participate in the 10-week Photovoice program after completing all study assessments.~Enhanced Control: The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session. It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month fo"
11204363|NCT02221648|FG001|Participant Flow|ArbobotulinumtoxinA Treatment|"Subjects will receive intervention injections with the study drug abobotulinumtoxinA.~AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment."
10804240|NCT03835351|OG000|Outcome|Intraoperative Urinary Catheter|"After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.~Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case"
10804241|NCT03835351|OG001|Outcome|No Intraoperative Urinary Catheter|No intraoperative urinary catheter will be used during the case
10804242|NCT03835351|EG000|Reported Event|Intraoperative Urinary Catheter|"After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.~Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case"
10804243|NCT03835351|EG001|Reported Event|No Intraoperative Urinary Catheter|No intraoperative urinary catheter will be used during the case
10804244|NCT03823300|BG000|Baseline|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804245|NCT03823300|BG001|Baseline|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804246|NCT03823300|BG002|Baseline|Total|Total of all reporting groups
10804247|NCT03823300|FG000|Participant Flow|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804248|NCT03823300|FG001|Participant Flow|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804249|NCT03823300|OG000|Outcome|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804250|NCT03823300|OG001|Outcome|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10820459|NCT00058058|OG001|Outcome|Reference Standard Negative (RS-)|Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.
11204364|NCT02221648|OG000|Outcome|Placebo|Subjects will be randomized to receive injections with saline.
11204365|NCT02221648|OG001|Outcome|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
11204366|NCT02221648|OG000|Outcome|Placebo|Study group received placebo injection.
11204367|NCT02221648|OG001|Outcome|botulinumtoxinA Treatment|Subjects received botox injection.
11204368|NCT02221648|OG000|Outcome|Placebo|"Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.~Placebo: Subjects will be randomization to receive either the study drug or the placebo group."
11204369|NCT02221648|OG001|Outcome|AbobotulinumtoxinA Treatment|"Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.~AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA."
11204370|NCT02221648|EG000|Reported Event|Placebo|Subjects will be randomized to receive injections with placebo.
11204371|NCT02221648|EG001|Reported Event|ArbobotulinumtoxinA Treatment|AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
11204372|NCT02221674|BG000|Baseline|Participants Aged 6 Months to Less Than 2 Years|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
11204373|NCT02221674|BG001|Baseline|Participants Aged 1 Month to Less Than 6 Months|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
11204374|NCT02221674|BG002|Baseline|Participants Aged From Birth to Less Than 1 Month|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
11204375|NCT02221674|BG003|Baseline|Total|Total of all reporting groups
11204376|NCT02221674|FG000|Participant Flow|Participants Aged 6 Months to Less Than 2 Years|"Infants aged 6 months to less than 2 years at the time of allocation to IMP (investigational medicinal product).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
11204377|NCT02221674|FG001|Participant Flow|Participants Aged 1 Month to Less Than 6 Months|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
11286150|NCT02884427|FG001|Participant Flow|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
10804251|NCT03823300|EG000|Reported Event|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804252|NCT03823300|EG001|Reported Event|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804253|NCT03823287|BG000|Baseline|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804254|NCT03823287|BG001|Baseline|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804255|NCT03823287|BG002|Baseline|Total|Total of all reporting groups
10804256|NCT03823287|FG000|Participant Flow|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804257|NCT03823287|FG001|Participant Flow|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804258|NCT03823287|OG000|Outcome|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804259|NCT03823287|OG001|Outcome|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10967020|NCT00891020|OG002|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967021|NCT00891020|OG000|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967022|NCT00891020|OG000|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967023|NCT00891020|EG000|Reported Event|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967024|NCT00891020|EG001|Reported Event|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
11286151|NCT02884427|FG002|Participant Flow|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
10804260|NCT03823287|EG000|Reported Event|Arm A: Faricimab|Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
10804261|NCT03823287|EG001|Reported Event|Arm B: Aflibercept|Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
10804262|NCT03815175|BG000|Baseline|XIENCE|"XIENCE + 1 month DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT (aspirin and/or P2Y12 receptor inhibitor): 1-month clear subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up."
10804263|NCT03815175|FG000|Participant Flow|XIENCE|"XIENCE + 1 month dual antiplatelet therapy (DAPT)~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT (aspirin and/or P2Y12 receptor inhibitor): 1-month clear subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up."
10804264|NCT03815175|OG000|Outcome|XIENCE|"XIENCE + 1 month DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT (aspirin and/or P2Y12 receptor inhibitor): 1-month clear subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up."
10804265|NCT03815175|EG000|Reported Event|XIENCE|"XIENCE + 1 month DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT (aspirin and/or P2Y12 receptor inhibitor): 1-month clear subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up."
10804266|NCT03812224|BG000|Baseline|Placebo QM|Participants randomized to receive placebo once a month (QM) for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
10804267|NCT03812224|BG001|Baseline|Erenumab 70 mg QM|Participants randomized to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
10804268|NCT03812224|BG002|Baseline|Total|Total of all reporting groups
10804269|NCT03812224|FG000|Participant Flow|Placebo QM|Participants randomized to receive placebo once a month (QM) for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
10804270|NCT03812224|FG001|Participant Flow|Erenumab 70 mg QM|Participants randomized to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
11244066|NCT02508480|OG000|Outcome|Photovoice|"Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format.~Photovoice: The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness.~In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination."
10804271|NCT03812224|OG000|Outcome|Placebo QM|Participants received placebo once a month for 24 weeks during the double-blind treatment period.
10804272|NCT03812224|OG001|Outcome|Erenumab 70 mg QM|Participants received erenumab 70 mg once a month for 24 weeks during the double-blind treatment period.
10804273|NCT03812224|EG000|Reported Event|Double-blind Treatment Period: Placebo QM|Participants received placebo once a month for 24 weeks during the double-blind treatment period.
10804274|NCT03812224|EG001|Reported Event|Double-blind Treatment Period: Erenumab 70 mg QM|Participants received erenumab 70 mg once a month for 24 weeks during the double-blind treatment period.
10804275|NCT03812224|EG002|Reported Event|Open-label Treatment Period: Erenumab 70 mg QM|Participants received erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
10847537|NCT00283712|BG001|Baseline|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
10847538|NCT00283712|BG002|Baseline|Total|Total of all reporting groups
10804276|NCT03794024|BG000|Baseline|Dorsal Column Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator~The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10804277|NCT03794024|BG001|Baseline|Dorsal Root Ganglion Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System~The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II"
10804278|NCT03794024|BG002|Baseline|Total|Total of all reporting groups
10804279|NCT03794024|FG000|Participant Flow|Dorsal Column Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator~The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10804280|NCT03794024|FG001|Participant Flow|Dorsal Root Ganglion Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System~The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II"
10804281|NCT03794024|OG000|Outcome|Dorsal Column Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator~The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10804282|NCT03794024|OG001|Outcome|Dorsal Root Ganglion Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System~The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II"
10804283|NCT03794024|EG000|Reported Event|Dorsal Column Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator~The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
10804284|NCT03794024|EG001|Reported Event|Dorsal Root Ganglion Stimulation|"Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System~The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II"
11244067|NCT02508480|OG001|Outcome|Enhanced Control|"Participants in this arm will attend a 60-minute peer-led group discussion on stigma and discrimination, and be eligible to participate in the 10-week Photovoice program after completing all study assessments.~Enhanced Control: The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session. It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month fo"
10804285|NCT03770455|BG000|Baseline|Avelumab + 2nd Generation ADT|"Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)"
10804286|NCT03770455|FG000|Participant Flow|Avelumab + 2nd Generation ADT|"Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)"
10804287|NCT03770455|OG000|Outcome|Avelumab + 2nd Generation ADT|"Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)"
10804288|NCT03770455|EG000|Reported Event|Avelumab + 2nd Generation ADT|"Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT~2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)"
10804289|NCT03714178|BG000|Baseline|FARAPULSE Endocardial Ablation|"Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.~FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System."
10804290|NCT03714178|FG000|Participant Flow|FARAPULSE Endocardial Ablation|"Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.~FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System."
10804291|NCT03714178|OG000|Outcome|FARAPULSE Endocardial Ablation|"Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.~FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System."
11204378|NCT02221674|FG002|Participant Flow|Participants Aged From Birth to Less Than 1 Month|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
11204379|NCT02221674|OG000|Outcome|Participants Aged 6 Months to Less Than 2 Years - PK Set|Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.
11204380|NCT02221674|OG000|Outcome|Participants Aged 1 Month to Less Than 6 Months - PK Set|Infants aged 1 month to less than 6 months at the time of allocation to IMP who had quantifiable serum concentrations.
11204381|NCT02221674|OG000|Outcome|Participants Aged From Birth to Less Than 1 Month - PK Set|Neonates aged less than 1 month (must be ≥37 weeks gestational age) at the time of allocation to IMP who had quantifiable serum concentrations.
11204382|NCT02221674|OG000|Outcome|Participants Aged 6 Months to Less Than 2 Years.|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
11204383|NCT02221674|OG001|Outcome|Participants Aged 1 Month to Less Than 6 Months.|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
11204384|NCT02221674|OG002|Outcome|Participants Aged From Birth to Less Than 1 Month.|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
11204385|NCT02221674|EG000|Reported Event|Participants Aged 6 Months to Less Than 2 Years.|"Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg."
11204386|NCT02221674|EG001|Reported Event|Participants Aged 1 Month to Less Than 6 Months.|"Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg."
11204387|NCT02221674|EG002|Reported Event|Participants Aged From Birth to Less Than 1 Month.|"Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age).~Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight.~Neonates aged less than 1 month received a dose of 0.50 mg/kg."
11204388|NCT02221739|BG000|Baseline|Ipilimumab + Radiotherapy|"Patients receive ipilimumab (Ipi) 3mg/kg i.v. over 90 minutes, within 24 hours of starting radiotherapy (RT) to the biopsied lesion, 6 Gy x5, later changed to 9.5 Gy x3 (conformally or by intensity modulated RT (IMRT) with image guidance to maximally spare normal tissue). Ipilimumab is repeated on days 22, 43 (for patients who consent to the first biopsy), and 64. Repeat biopsy is performed between day 22-29, and patients are re-imaged between day 81-88 and evaluated for response (defined as an objective response by irRC of the measurable metastatic sites outside the radiation field).~Ipilimumab~Radiotherapy (IMRT or 3-D CRT)"
11204389|NCT02221739|FG000|Participant Flow|Ipilimumab + Radiotherapy|"Patients receive ipilimumab (Ipi) 3mg/kg i.v. over 90 minutes, within 24 hours of starting radiotherapy (RT) to the biopsied lesion, 6 Gy x5, later changed to 9.5 Gy x3 (conformally or by intensity modulated RT (IMRT) with image guidance to maximally spare normal tissue). Ipilimumab is repeated on days 22, 43 (for patients who consent to the first biopsy), and 64. Repeat biopsy is performed between day 22-29, and patients are re-imaged between day 81-88 and evaluated for response (defined as an objective response by irRC of the measurable metastatic sites outside the radiation field).~Ipilimumab~Radiotherapy (IMRT or 3-D CRT)"
11204390|NCT02221739|OG000|Outcome|Ipilimumab + Radiotherapy|"Patients receive ipilimumab (Ipi) 3mg/kg i.v. over 90 minutes, within 24 hours of starting radiotherapy (RT) to the biopsied lesion, 6 Gy x5, later changed to 9.5 Gy x3 (conformally or by intensity modulated RT (IMRT) with image guidance to maximally spare normal tissue). Ipilimumab is repeated on days 22, 43 (for patients who consent to the first biopsy), and 64. Repeat biopsy is performed between day 22-29, and patients are re-imaged between day 81-88 and evaluated for response (defined as an objective response by irRC of the measurable metastatic sites outside the radiation field).~Ipilimumab~Radiotherapy (IMRT or 3-D CRT)"
11204391|NCT02221739|EG000|Reported Event|Ipilimumab + Radiotherapy|"Patients receive ipilimumab (Ipi) 3mg/kg i.v. over 90 minutes, within 24 hours of starting radiotherapy (RT) to the biopsied lesion, 6 Gy x5, later changed to 9.5 Gy x3 (conformally or by intensity modulated RT (IMRT) with image guidance to maximally spare normal tissue). Ipilimumab is repeated on days 22, 43 (for patients who consent to the first biopsy), and 64. Repeat biopsy is performed between day 22-29, and patients are re-imaged between day 81-88 and evaluated for response (defined as an objective response by irRC of the measurable metastatic sites outside the radiation field).~Ipilimumab~Radiotherapy (IMRT or 3-D CRT)"
11204392|NCT02221869|BG000|Baseline|Enrolled Population|The Enrolled Population consists of all subjects who were dispensed study drug.
11204393|NCT02221869|BG001|Baseline|Placebo (Efficacy Population)|Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks in the 2-week double-blind treatment period.
11204394|NCT02221869|BG002|Baseline|Xyrem (Efficacy Population)|Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen taken in the prior 2 weeks in the 2-week double-blind treatment period.
11204395|NCT02221869|BG003|Baseline|Total|Total of all reporting groups
11204396|NCT02221869|FG000|Participant Flow|Randomized to Xyrem|Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen taken in the prior 2 weeks.
10804292|NCT03714178|EG000|Reported Event|FARAPULSE Endocardial Ablation|"Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.~FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System."
10804293|NCT03709342|BG000|Baseline|All Patients|CM4620-IE: single IV infusion on Day 1 over 4 hours
10804294|NCT03709342|FG000|Participant Flow|All Patients|CM4620-IE: single IV infusion on Day 1 over 4 hours
10804295|NCT03709342|OG000|Outcome|All Patients|CM4620-IE: single IV infusion on Day 1 over 4 hours
10804296|NCT03709342|EG000|Reported Event|All Patients|CM4620-IE: single IV infusion on Day 1 over 4 hours
10804297|NCT03691623|BG000|Baseline|Part 1: EDP-938 600 mg|Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.
10804298|NCT03691623|BG001|Baseline|Part 1: EDP-938 500 mg Then 300 mg|Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.
10804299|NCT03691623|BG002|Baseline|Part 1: Placebo|Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.
10804300|NCT03691623|BG003|Baseline|Part 2: EDP-938 600 mg Then 300 mg|Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.
10804301|NCT03691623|BG004|Baseline|Part 2: EDP-938 400 mg Then 200 mg|Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.
10804302|NCT03691623|BG005|Baseline|Part 2: Placebo|Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
10804303|NCT03691623|BG006|Baseline|Total|Total of all reporting groups
10804304|NCT03691623|FG000|Participant Flow|Part 1: EDP-938 600 mg|Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.
10804305|NCT03691623|FG001|Participant Flow|Part 1: EDP-938 500 mg Then 300 mg|Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.
10804306|NCT03691623|FG002|Participant Flow|Part 1: Placebo|Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.
11204397|NCT02221869|FG001|Participant Flow|Randomized to Xyrem Placebo|Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
10804307|NCT03691623|FG003|Participant Flow|Part 2: EDP-938 600 mg Then 300 mg|Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.
10804308|NCT03691623|FG004|Participant Flow|Part 2: EDP-938 400 mg Then 200 mg|Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.
10804309|NCT03691623|FG005|Participant Flow|Part 2: Placebo|Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
10804310|NCT03691623|OG000|Outcome|Part 1: EDP-938 600 mg|Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.
10804311|NCT03691623|OG001|Outcome|Part 1: EDP-938 500 mg Then 300 mg|Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.
10804312|NCT03691623|OG002|Outcome|Part 1: Placebo|Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.
10804313|NCT03691623|OG003|Outcome|Part 2: EDP-938 600 mg Then 300 mg|Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.
10804314|NCT03691623|OG004|Outcome|Part 2: EDP-938 400 mg Then 200 mg|Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.
10804315|NCT03691623|OG005|Outcome|Part 2: Placebo|Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
11204398|NCT02221869|FG002|Participant Flow|Open-label Xyrem|Subjects who were not randomized or continued to receive open-label Xyrem during the Double-blind Treatment Period.
10804316|NCT03691623|OG002|Outcome|Part 2: EDP-938 600 mg Then 300 mg|Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.
10804317|NCT03691623|OG003|Outcome|Part 2: EDP-938 400 mg Then 200 mg|Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.
10804318|NCT03691623|OG001|Outcome|Part 1: EDP-938 500 mg Then 300 mg|Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days
10804319|NCT03691623|EG000|Reported Event|Part 1: EDP-938 600 mg|Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.
10804320|NCT03691623|EG001|Reported Event|Part 1: EDP-938 500 mg Then 300 mg|Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.
10804321|NCT03691623|EG002|Reported Event|Part 1: Placebo|Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.
10804322|NCT03691623|EG003|Reported Event|Part 2: EDP-938 600 mg Then 300 mg|Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.
11204399|NCT02221869|OG000|Outcome|Xyrem|Active Xyrem continued as a double-blind treatment at the stable dose taken and regimen used in the prior 2 weeks.
11204400|NCT02221869|OG001|Outcome|Xyrem Placebo|Xyrem placebo was initiated as a double-blind treatment at a volume and regimen equivalent to the Xyrem dose taken in the prior 2 weeks.
11204401|NCT02221869|EG000|Reported Event|Safety Population|Safety population who took study drug
11204402|NCT02221869|EG001|Reported Event|Randomized Placebo|Subjects assigned to the Randomized Placebo group during the Double-blind Treatment Period. Adverse events with onset on or after the first dose in the Double-blind Treatment Period and prior to the date of first dose in the Open-label Safety Period are presented.
11204403|NCT02221882|BG000|Baseline|300 mg LY3164530 Schedule 1|300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
11204404|NCT02221882|BG001|Baseline|600 mg LY3164530 Schedule 1|600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
11204405|NCT02221882|BG002|Baseline|1000 mg LY3164530 Schedule 1|1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204406|NCT02221882|BG003|Baseline|1250 mg LY3164530 Schedule 1|1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204407|NCT02221882|BG004|Baseline|500 mg LY3164530 Schedule 2|500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204408|NCT02221882|BG005|Baseline|600 mg LY3164530 Schedule 2|600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204409|NCT02221882|BG006|Baseline|Total|Total of all reporting groups
11204410|NCT02221882|FG000|Participant Flow|300 mg LY3164530 Schedule 1|300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
11204411|NCT02221882|FG001|Participant Flow|600 mg LY3164530 Schedule 1|600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
11204412|NCT02221882|FG002|Participant Flow|1000 mg LY3164530 Schedule 1|1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204413|NCT02221882|FG003|Participant Flow|1250 mg LY3164530 Schedule 1|1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204414|NCT02221882|FG004|Participant Flow|500 mg LY3164530 Schedule 2|500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204415|NCT02221882|FG005|Participant Flow|600 mg LY3164530 Schedule 2|600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204416|NCT02221882|OG000|Outcome|Schedule 1|LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
11204417|NCT02221882|OG001|Outcome|Schedule 2|LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
11204418|NCT02221882|OG000|Outcome|300 mg LY3164530 Schedule 1|300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
11204419|NCT02221882|OG001|Outcome|600 mg LY3164530 Schedule 1|600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
11204420|NCT02221882|OG002|Outcome|1000 mg LY3164530 Schedule 1|1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204421|NCT02221882|OG003|Outcome|1250 mg LY3164530 Schedule 1|1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204422|NCT02221882|OG004|Outcome|500 mg LY3164530 Schedule 2|500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204423|NCT02221882|OG005|Outcome|600 mg LY3164530 Schedule 2|600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204424|NCT02221882|OG000|Outcome|300mg LY3164530 Schedule 1|300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
11204425|NCT02221882|OG003|Outcome|1250 mg LY3164530 Schedule 1|1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204426|NCT02221882|OG005|Outcome|600 mg LY3164530 Schedule 2|600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle
11204427|NCT02221882|EG000|Reported Event|300 mg LY3164530 Schedule 1|300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
11204428|NCT02221882|EG001|Reported Event|600 mg LY3164530 Schedule 1|600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
11204429|NCT02221882|EG002|Reported Event|1000 mg LY3164530 Schedule 1|1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204430|NCT02221882|EG003|Reported Event|1250 mg LY3164530 Schedule 1|1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
11204431|NCT02221882|EG004|Reported Event|500 mg LY3164530 Schedule 2|500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204432|NCT02221882|EG005|Reported Event|600 mg LY3164530 Schedule 2|600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
11204433|NCT02221947|BG000|Baseline|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
11204434|NCT02221947|BG001|Baseline|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
11204435|NCT02221947|BG002|Baseline|Total|Total of all reporting groups
11204436|NCT02221947|FG000|Participant Flow|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
11204437|NCT02221947|FG001|Participant Flow|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
11204438|NCT02221947|OG000|Outcome|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
11204439|NCT02221947|OG001|Outcome|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
11204440|NCT02221947|OG000|Outcome|Bryostatin 1|Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
11204441|NCT02221947|OG001|Outcome|Placebo|Placebo: Placebo, single dose via intravenous infusion over 1 hour.
11204442|NCT02221947|OG001|Outcome|Placebo|Placebo: single dose via intravenous infusion over 1 hour.
11204443|NCT02221947|EG000|Reported Event|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
11204444|NCT02221947|EG001|Reported Event|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
11204445|NCT02222129|BG000|Baseline|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
11204446|NCT02222129|BG001|Baseline|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
11204447|NCT02222129|BG002|Baseline|Total|Total of all reporting groups
11204448|NCT02222129|FG000|Participant Flow|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
11204449|NCT02222129|FG001|Participant Flow|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
11204450|NCT02222129|OG000|Outcome|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
11204451|NCT02222129|OG001|Outcome|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
11204452|NCT02222129|EG000|Reported Event|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
11204453|NCT02222129|EG001|Reported Event|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
11204454|NCT02222181|BG000|Baseline|Treatment|patients in treatment for Alzheimer's disease.
11204455|NCT02222181|FG000|Participant Flow|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
11204456|NCT02222181|OG000|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
11204457|NCT02222181|EG000|Reported Event|Treatment|Do not apply.
11204458|NCT02222207|BG000|Baseline|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
10804323|NCT03691623|EG004|Reported Event|Part 2: EDP-938 400 mg Then 200 mg|Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.
10804324|NCT03691623|EG005|Reported Event|Part 2: Placebo|Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
10804325|NCT03689374|BG000|Baseline|Semaglutide|Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety.
10804326|NCT03689374|BG001|Baseline|Insulin Aspart|Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety.
10804327|NCT03689374|BG002|Baseline|Total|Total of all reporting groups
10804328|NCT03689374|FG000|Participant Flow|All Participants|During run-in period insulin glargine in combination with metformin was to be optimized. All enrolled participants received metformin orally and IGlar U100 s.c. injection in run-in period. Metformin was optimized in dose range of greater than or equal to (>=) 1500 milligrams (mg) to less than or equal to (<=) 3000 mg. After run-in period, participants were randomized 1:1 to receive add-on treatment with semaglutide once weekly or insulin aspart three times daily (TID) in treatment period.
10804329|NCT03689374|FG001|Participant Flow|Semaglutide|Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety.
10804330|NCT03689374|FG002|Participant Flow|Insulin Aspart|Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety.
10804331|NCT03689374|OG000|Outcome|Semaglutide|Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety.
10847539|NCT00283712|FG000|Participant Flow|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
11204459|NCT02222207|FG000|Participant Flow|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
11204460|NCT02222207|OG000|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
11204461|NCT02222207|EG000|Reported Event|Part A Regorafenib|Participants self-administered 30 mg/mL, 25 mcL, 1 drop of regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
11204462|NCT02222246|BG000|Baseline|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
10804332|NCT03689374|OG001|Outcome|Insulin Aspart|Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety.
10804333|NCT03689374|EG000|Reported Event|Semaglutide|Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety.
10804334|NCT03689374|EG001|Reported Event|Insulin Aspart|Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety.
10804335|NCT03604549|BG000|Baseline|Saline|"Women in this arm will receive a flush with saline after normal saline Sono HSG.~Saline: Up to 10cc of saline will be infused via intrauterine catheter"
10804336|NCT03604549|BG001|Baseline|Lipiodol UF|"Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.~Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter"
10804337|NCT03604549|BG002|Baseline|Total|Total of all reporting groups
10804338|NCT03604549|FG000|Participant Flow|Saline|"Women in this arm will receive a flush with saline after normal saline Sono Hystersalpingography. .~Saline: Up to 10cc of saline will be infused via intrauterine catheter"
10804339|NCT03604549|FG001|Participant Flow|Lipiodol UF|"Women in this arm will receive a flush with Lipiodol UF after normal saline Sono Hystersalpingography.~Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter"
10804340|NCT03604549|OG000|Outcome|Saline|"Women in this arm will receive a flush with saline after normal saline Sono HSG.~Saline: Up to 10cc of saline will be infused via intrauterine catheter"
10804341|NCT03604549|OG001|Outcome|Lipiodol UF|"Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.~Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter"
10804342|NCT03604549|EG000|Reported Event|Saline|"Women in this arm will receive a flush with saline after normal saline Sono HSG.~Saline: Up to 10cc of saline will be infused via intrauterine catheter"
11204463|NCT02222246|BG001|Baseline|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
10804343|NCT03604549|EG001|Reported Event|Lipiodol UF|"Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.~Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter"
10804344|NCT03603639|BG000|Baseline|All Participants|Participants received E2730-matched placebo (Treatment A) or E2730 40 mg (Treatment B) or E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 1 to 3 as per assigned treatment sequence. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804345|NCT03603639|FG000|Participant Flow|Sequence 1: Placebo + E2730 40 mg + E2730 120 mg|Participants received, E2730-matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 1, followed by E2730 40 milligram (mg) (Treatment B) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804346|NCT03603639|FG001|Participant Flow|Sequence 2: E2730 40 mg + E2730 120 mg + Placebo|Participants received, E2730 40 mg (Treatment B) capsule, orally, once on Day 1 in Treatment Period 1, followed by E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730-matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804347|NCT03603639|FG002|Participant Flow|Sequence 3: E2730 120 mg + Placebo + E2730 40 mg|Participants received, E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 1, followed by E2730 -matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730 40 mg (Treatment B) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
11204464|NCT02222246|BG002|Baseline|Total|Total of all reporting groups
11204465|NCT02222246|FG000|Participant Flow|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent National Heart, Lung, and Blood Institute (NHBLI) recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a Sickle Cell Disease (SCD) specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
11204466|NCT02222246|FG001|Participant Flow|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
11204467|NCT02222246|OG000|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
11204468|NCT02222246|OG001|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
11204469|NCT02222246|OG000|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
11204470|NCT02222246|OG001|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
11204471|NCT02222246|EG000|Reported Event|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.~Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.~Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
11244068|NCT02508480|EG000|Reported Event|Photovoice|"Participants in this arm will attend a 10-week peer-led Photovoice program conducted in group format.~Photovoice: The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness.~In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination."
11286152|NCT02884427|OG000|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
10804348|NCT03603639|FG003|Participant Flow|Sequence 4: Placebo + E2730 120 mg + E2730 40 mg|Participants received, E2730-matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 1, followed by E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730 40 mg (Treatment B) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804349|NCT03603639|FG004|Participant Flow|Sequence 5: E2730 40 mg + Placebo + E2730 120 mg|Participants received, E2730 40 mg (Treatment B) capsule, once on Day 1 in Treatment Period 1, followed by E2730 -matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804350|NCT03603639|FG005|Participant Flow|Sequence 6: E2730 120 mg + E2730 40 mg + Placebo|Participants received, E2730 120 mg (Treatment C) capsule, orally, once on Day 1 in Treatment Period 1, followed by E2730 40 mg (Treatment B) capsule, orally, once on Day 1 in Treatment Period 2, followed by E2730-matched placebo (Treatment A) capsule, orally, once on Day 1 in Treatment Period 3. A washout period of at least 3 weeks was maintained between all the treatment periods.
10804351|NCT03603639|OG000|Outcome|Treatment A: Placebo|Participants received, E2730-matched placebo capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804352|NCT03603639|OG001|Outcome|Treatment B: E2730 40 mg|Participants received, E2730 40 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804353|NCT03603639|OG002|Outcome|Treatment C: E2730 120 mg|Participants received, E2730 120 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804354|NCT03603639|OG000|Outcome|Treatment B: E2730 40 mg|Participants received, E2730 40 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804355|NCT03603639|OG001|Outcome|Treatment C: E2730 120 mg|Participants received, E2730 120 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804356|NCT03603639|EG000|Reported Event|Treatment A: Placebo|Participants received, E2730-matched placebo capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804357|NCT03603639|EG001|Reported Event|Treatment B: E2730 40 mg|Participants received, E2730 40 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804358|NCT03603639|EG002|Reported Event|Treatment C: E2730 120 mg|Participants received, E2730 120 mg capsule, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3.
10804359|NCT03587636|BG000|Baseline|Bupivacaine Interscalene Block|"20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.~Bupivacaine: interscalene block with bupivacaine"
10804360|NCT03587636|BG001|Baseline|Liposome Bupivacaine Interscalene Block|"10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance~liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine"
10804361|NCT03587636|BG002|Baseline|Total|Total of all reporting groups
11286153|NCT02884427|OG001|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
10804362|NCT03587636|FG000|Participant Flow|Bupivacaine Interscalene Block|"20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.~Bupivacaine: interscalene block with bupivacaine"
10804363|NCT03587636|FG001|Participant Flow|Liposome Bupivacaine Interscalene Block|"10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance~liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine"
10804364|NCT03587636|OG000|Outcome|Bupivacaine Interscalene Block|"20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.~Bupivacaine: interscalene block with bupivacaine"
10804365|NCT03587636|OG001|Outcome|Liposome Bupivacaine Interscalene Block|"10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance~liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine"
10804366|NCT03587636|EG000|Reported Event|Bupivacaine Interscalene Block|"20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.~Bupivacaine: interscalene block with bupivacaine"
10804367|NCT03587636|EG001|Reported Event|Liposome Bupivacaine Interscalene Block|"10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance~liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine"
10804368|NCT03574129|BG000|Baseline|Adolescent Transition Package|Baseline characteristics of participants in intervention arm
10804369|NCT03574129|BG001|Baseline|Standard of Care|Baseline characteristics of participants in control arm
10804370|NCT03574129|BG002|Baseline|Total|Total of all reporting groups
10804371|NCT03574129|FG000|Participant Flow|Adolescent Transition Package|Received the study intervention
10804372|NCT03574129|FG001|Participant Flow|Standard of Care|Did not receive study intervention
10804373|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 transition readiness score (Total score)
10804374|NCT03574129|OG001|Outcome|Standard of Care|Month 12 transition readiness score (Total score)
10804375|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 transition readiness score (HIV literacy)
10804376|NCT03574129|OG001|Outcome|Standard of Care|Month 12 transition readiness score (HIV literacy)
10804377|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 transition readiness score (self management)
10804378|NCT03574129|OG001|Outcome|Standard of Care|Month 12 transition readiness score (self management)
10804379|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 transition readiness score (communication)
10804380|NCT03574129|OG001|Outcome|Standard of Care|Month 12 transition readiness score (communication)
11204472|NCT02222246|EG001|Reported Event|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.~Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).~Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
11204473|NCT02222337|BG000|Baseline|Nueva Vida Intervention|"Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
11204474|NCT02222337|BG001|Baseline|Usual Care|Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11204475|NCT02222337|BG002|Baseline|Total|Total of all reporting groups
11204476|NCT02222337|FG000|Participant Flow|Nueva Vida Intervention|"Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
11204477|NCT02222337|FG001|Participant Flow|Usual Care|Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11204478|NCT02222337|OG000|Outcome|Usual Care Survivors|Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11204479|NCT02222337|OG001|Outcome|Usual Care Caregivers|Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11204480|NCT02222337|OG002|Outcome|Nueva Vida Intervetion Survivors|"Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
11204481|NCT02222337|OG003|Outcome|Nueva Vida Intervention Caregivers|"Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
11204482|NCT02222337|OG000|Outcome|Nueva Vida Intervention|"Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
10804381|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 transition readiness score (support)
11204483|NCT02222337|OG001|Outcome|Usual Care|Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11286154|NCT02884427|OG002|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
10804382|NCT03574129|OG001|Outcome|Standard of Care|Month 12 transition readiness score (support)
10804383|NCT03574129|OG000|Outcome|Adolescent Transition Package|Month 12 retention in study
10804384|NCT03574129|OG001|Outcome|Standard of Care|Month 12 retention in study
10804385|NCT03574129|OG000|Outcome|Adolescent Transition Package|Proportion with viral suppression
10804386|NCT03574129|OG001|Outcome|Standard of Care|Proportion with viral suppression
10804387|NCT03574129|EG000|Reported Event|Adolescent Transition Package|Proportion with adverse event
10804388|NCT03574129|EG001|Reported Event|Standard of Care|Proportion with adverse event
11286155|NCT02884427|EG000|Reported Event|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.~Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
11204484|NCT02222337|EG000|Reported Event|Nueva Vida Intervention|"Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.~Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication."
11204485|NCT02222337|EG001|Reported Event|Usual Care|Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
11204486|NCT02222493|BG000|Baseline|PF-06438179|Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
11204487|NCT02222493|BG001|Baseline|Infliximab-EU Remicade (INX)|Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
11204488|NCT02222493|BG002|Baseline|Total|Total of all reporting groups
11204489|NCT02222493|FG000|Participant Flow|PF-06438179|Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
11204490|NCT02222493|FG001|Participant Flow|Infliximab-EU Remicade (INX)|Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
11204491|NCT02222493|OG000|Outcome|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
11204492|NCT02222493|OG001|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
11204493|NCT02222493|OG000|Outcome|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11204494|NCT02222493|OG001|Outcome|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11204495|NCT02222493|OG002|Outcome|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
10967025|NCT00891020|EG002|Reported Event|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
10967026|NCT00891046|BG000|Baseline|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967027|NCT00891046|BG001|Baseline|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11204496|NCT02222493|OG000|Outcome|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204497|NCT02222493|OG001|Outcome|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204498|NCT02222493|OG002|Outcome|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204499|NCT02222493|OG001|Outcome|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
11204500|NCT02222493|EG000|Reported Event|Period 1: PF-06438179|Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
11204501|NCT02222493|EG001|Reported Event|Period 1: Infliximab-EU Remicade (INX)|Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
11204502|NCT02222493|EG002|Reported Event|Period 2: PF-06438179/PF-06438179|Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11204503|NCT02222493|EG003|Reported Event|Period 2: INX/INX|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11204504|NCT02222493|EG004|Reported Event|Period 2: INX/PF-06438179|Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11204505|NCT02222493|EG005|Reported Event|Period 3: PF-06438179/PF-06438179/PF-06438179|Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204506|NCT02222493|EG006|Reported Event|Period 3: INX/INX/PF-06438179|Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204507|NCT02222493|EG007|Reported Event|Period 3: INX/PF-06438179/PF-06438179|Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
11204508|NCT02222558|BG000|Baseline|All Study Participants|"Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.~Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204509|NCT02222558|FG000|Participant Flow|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
11204510|NCT02222558|FG001|Participant Flow|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
11204511|NCT02222558|FG002|Participant Flow|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204512|NCT02222558|FG003|Participant Flow|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204513|NCT02222558|FG004|Participant Flow|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204514|NCT02222558|FG005|Participant Flow|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204515|NCT02222558|OG000|Outcome|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
11204516|NCT02222558|OG001|Outcome|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
11204517|NCT02222558|OG002|Outcome|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204518|NCT02222558|OG003|Outcome|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204519|NCT02222558|OG004|Outcome|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204520|NCT02222558|OG005|Outcome|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204521|NCT02222558|EG000|Reported Event|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
11204522|NCT02222558|EG001|Reported Event|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
11204523|NCT02222558|EG002|Reported Event|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204524|NCT02222558|EG003|Reported Event|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204525|NCT02222558|EG004|Reported Event|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204526|NCT02222558|EG005|Reported Event|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
11204527|NCT02222610|BG000|Baseline|Cohort A|"Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.~Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a dry macula. For a macula to be considered dry persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.~0.5 mg ranibizumab"
11204528|NCT02222610|BG001|Baseline|Cohort B|"Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204529|NCT02222610|BG002|Baseline|Cohort C|"Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204530|NCT02222610|BG003|Baseline|Total|Total of all reporting groups
11204531|NCT02222610|FG000|Participant Flow|Cohort A|"Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.~Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a dry macula. For a macula to be considered dry persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.~0.5 mg ranibizumab"
11204532|NCT02222610|FG001|Participant Flow|Cohort B|"Subject's receive monthly treatment of intravitreal (IVT) 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204533|NCT02222610|FG002|Participant Flow|Cohort C|"Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204534|NCT02222610|OG000|Outcome|Cohort A|"Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.~Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a dry macula. For a macula to be considered dry persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.~0.5 mg ranibizumab"
11204535|NCT02222610|OG001|Outcome|Cohort B|"Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204536|NCT02222610|OG002|Outcome|Cohort C|"Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204537|NCT02222610|EG000|Reported Event|Cohort A|"Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.~Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a dry macula. For a macula to be considered dry persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.~0.5 mg ranibizumab"
11204538|NCT02222610|EG001|Reported Event|Cohort B|"Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204539|NCT02222610|EG002|Reported Event|Cohort C|"Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.~Starting at week 52, subject's will enter a treat & extend regime as described in cohort A.~0.5 mg ranibizumab~Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia"
11204540|NCT02222688|BG000|Baseline|Cirmtuzumab 0.015 - 0.03 mg/kg|Cohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion
11204541|NCT02222688|BG001|Baseline|Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg|Cohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion
11204542|NCT02222688|BG002|Baseline|Cirmtuzumab 0.5 - 1.0 mg/kg|Cohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion
11204543|NCT02222688|BG003|Baseline|Cirmtuzumab 2.0 - 4.0 mg/kg|Cohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion
11204544|NCT02222688|BG004|Baseline|Cirmtuzumab 8 mg/kg|Cohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion
11204545|NCT02222688|BG005|Baseline|Cirmtuzumab 16 mg/kg|Cohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion
11204546|NCT02222688|BG006|Baseline|Cirmtuzumab 20 mg/kg|Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg)
11204547|NCT02222688|BG007|Baseline|Total|Total of all reporting groups
11204548|NCT02222688|FG000|Participant Flow|Cirmtuzumab 0.015 - 0.03 mg/kg|Cohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion
11204549|NCT02222688|FG001|Participant Flow|Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg|Cohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion
11204550|NCT02222688|FG002|Participant Flow|Cirmtuzumab 0.5 - 1.0 mg/kg|Cohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion
11204551|NCT02222688|FG003|Participant Flow|Cimrtuzumab 2.0 - 4.0 mg/kg|Cohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion
11204552|NCT02222688|FG004|Participant Flow|Cirmtuzumab 8 mg/kg|Cohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion
11204553|NCT02222688|FG005|Participant Flow|Cirmtuzumab 16 mg/kg|Cohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion
11204554|NCT02222688|FG006|Participant Flow|Cirmtuzumab 20 mg/kg|Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg)
11204555|NCT02222688|OG000|Outcome|All Participants|All participants who received any treatment with cirmtuzumab
11204556|NCT02222688|OG000|Outcome|Cirmtuzumab 0.015 - 0.03 mg/kg|Cohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion
11204557|NCT02222688|OG001|Outcome|Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg|Cohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion
11204558|NCT02222688|OG002|Outcome|Cirmtuzumab 0.5 - 1.0 mg/kg|Cohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion
11204559|NCT02222688|OG003|Outcome|Cirmtuzumab 2.0 - 4.0 mg/kg|Cohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion
11204560|NCT02222688|OG004|Outcome|Cirmtuzumab 8 mg/kg|Cohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion
11204561|NCT02222688|OG005|Outcome|Cirmtuzumab 16 mg/kg|Cohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion
11204562|NCT02222688|OG006|Outcome|Cirmtuzumab 20 mg/kg|Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg)
11204563|NCT02222688|OG006|Outcome|Cirmtuzumab 20 mg/kg|Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion
11204564|NCT02222688|EG000|Reported Event|Cirmtuzumab 0.015 - 0.03 mg/kg|Cohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion
11204565|NCT02222688|EG001|Reported Event|Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg|Cohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion
11204566|NCT02222688|EG002|Reported Event|Cirmtuzumab 0.5 - 1.0 mg/kg|Cohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion
11204567|NCT02222688|EG003|Reported Event|Cimrtuzumab 2.0 - 4.0 mg/kg|Cohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion
11204568|NCT02222688|EG004|Reported Event|Cirmtuzumab 8 mg/kg|Cohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion
11204569|NCT02222688|EG005|Reported Event|Cirmtuzumab 16 mg/kg|Cohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion
11204570|NCT02222688|EG006|Reported Event|Cirmtuzumab 20 mg/kg|Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg)
11204571|NCT02222714|BG000|Baseline|120 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204572|NCT02222714|BG001|Baseline|240 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204573|NCT02222714|BG002|Baseline|360 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204574|NCT02222714|BG003|Baseline|540 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204575|NCT02222714|BG004|Baseline|Placebo|Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
11204576|NCT02222714|BG005|Baseline|Total|Total of all reporting groups
11204577|NCT02222714|FG000|Participant Flow|120 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204578|NCT02222714|FG001|Participant Flow|240 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204579|NCT02222714|FG002|Participant Flow|360 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204580|NCT02222714|FG003|Participant Flow|540 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204581|NCT02222714|FG004|Participant Flow|Placebo|"Matching placebo, q12h for up to 5 doses~Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204582|NCT02222714|OG000|Outcome|120 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204583|NCT02222714|OG001|Outcome|240 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204584|NCT02222714|OG002|Outcome|360 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204585|NCT02222714|OG003|Outcome|540 µg/kg of 3K3A-APC|"3K3A-APC, q12h for up to 5 doses~3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204586|NCT02222714|OG004|Outcome|Placebo|"Matching placebo, q12h for up to 5 doses~Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion"
11204587|NCT02222714|OG000|Outcome|3K3A-APC Total|All 3K3A-APC treated groups combined
11204588|NCT02222714|OG001|Outcome|Placebo|Placebo group
11204589|NCT02222714|EG000|Reported Event|120 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204590|NCT02222714|EG001|Reported Event|240 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204591|NCT02222714|EG002|Reported Event|360 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204592|NCT02222714|EG003|Reported Event|540 µg/kg of 3K3A-APC|3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
11204593|NCT02222714|EG004|Reported Event|3K3A-APC Total|All 3K3A-APC treated groups combined
11204594|NCT02222714|EG005|Reported Event|Placebo|Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
11204595|NCT02222818|BG000|Baseline|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
11204596|NCT02222818|BG001|Baseline|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
11204597|NCT02222818|BG002|Baseline|Total|Total of all reporting groups
11204598|NCT02222818|FG000|Participant Flow|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
11204599|NCT02222818|FG001|Participant Flow|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
11204600|NCT02222818|OG000|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
11204601|NCT02222818|OG001|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
11204602|NCT02222818|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled in the CRTee study.
11204603|NCT02222870|BG000|Baseline|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204604|NCT02222870|BG001|Baseline|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204605|NCT02222870|BG002|Baseline|Total|Total of all reporting groups
11204606|NCT02222870|FG000|Participant Flow|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204607|NCT02222870|FG001|Participant Flow|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204608|NCT02222870|OG000|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204609|NCT02222870|OG001|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204610|NCT02222870|EG000|Reported Event|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204611|NCT02222870|EG001|Reported Event|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
11204612|NCT02222896|BG000|Baseline|CHG, Vehicle, Comparator CHG|Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.
11204613|NCT02222896|FG000|Participant Flow|CHG Cloth|CHG 3 min application
11204614|NCT02222896|FG001|Participant Flow|Vehicle|Vehicle, 3 min application
11204615|NCT02222896|FG002|Participant Flow|Comparator CHG|CHG Comparator, 3 min application
11204616|NCT02222896|OG000|Outcome|CHG Cloth Abdomen|CHG 3 min application to abdomen
11204617|NCT02222896|OG001|Outcome|CHG Cloth Groin|CHG 3 min application to groin
11204618|NCT02222896|OG002|Outcome|Vehicle Abdomen|Vehicle 3 min application to abdomen
11204619|NCT02222896|OG003|Outcome|Vehicle Groin|Vehicle 3 min application to groin
11204620|NCT02222896|OG004|Outcome|Comparator CHG Abdomen|CHG comparator applied to abdomen
11204621|NCT02222896|OG005|Outcome|Comparator CHG Groin|CHG comparator applied to groin
11204622|NCT02222896|EG000|Reported Event|CHG Cloth|Single application
11204623|NCT02222896|EG001|Reported Event|Vehicle|Single application
11204624|NCT02222896|EG002|Reported Event|Comparative CHG|Single application
11204625|NCT02222922|BG000|Baseline|PF-06647020 0.2 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
11204626|NCT02222922|BG001|Baseline|PF-06647020 0.5 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
11204627|NCT02222922|BG002|Baseline|PF-06647020 1.25 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
11204628|NCT02222922|BG003|Baseline|PF-06647020 2.1 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204629|NCT02222922|BG004|Baseline|PF-06647020 2.8 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
11204630|NCT02222922|BG005|Baseline|PF-06647020 3.7 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204631|NCT02222922|BG006|Baseline|PF-06647020 2.1 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
11204632|NCT02222922|BG007|Baseline|PF-06647020 2.8 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
11204633|NCT02222922|BG008|Baseline|PF-06647020 3.2 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
11204634|NCT02222922|BG009|Baseline|Total|Total of all reporting groups
11204635|NCT02222922|FG000|Participant Flow|PF-06647020 0.2 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
11204636|NCT02222922|FG001|Participant Flow|PF-06647020 0.5 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
11204637|NCT02222922|FG002|Participant Flow|PF-06647020 1.25 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
11204638|NCT02222922|FG003|Participant Flow|PF-06647020 2.1 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204639|NCT02222922|FG004|Participant Flow|PF-06647020 2.8 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
11204640|NCT02222922|FG005|Participant Flow|PF-06647020 3.7 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204641|NCT02222922|FG006|Participant Flow|PF-06647020 2.1 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
11204642|NCT02222922|FG007|Participant Flow|PF-06647020 2.8 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
11204643|NCT02222922|FG008|Participant Flow|PF-06647020 3.2 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
11204644|NCT02222922|OG000|Outcome|PF-06647020 0.2 mg/kg（Q3W Regimen）|Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204645|NCT02222922|OG001|Outcome|PF-06647020 0.5 mg/kg (Q3W Regimen)|Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204646|NCT02222922|OG002|Outcome|PF-06647020 1.25 mg/kg (Q3W Regimen)|Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204647|NCT02222922|OG003|Outcome|PF-06647020 2.1 mg/kg (Q3W Regimen)|Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204648|NCT02222922|OG004|Outcome|PF-06647020 2.8 mg/kg (Q3W Regimen)|Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204649|NCT02222922|OG005|Outcome|PF-06647020 3.7 mg/kg (Q3W Regimen)|Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204650|NCT02222922|OG000|Outcome|PF-06647020 0.2 mg/kg（Q3W Regimen）|Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
11204651|NCT02222922|OG001|Outcome|PF-06647020 0.5 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
11204652|NCT02222922|OG002|Outcome|PF-06647020 1.25 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
11204653|NCT02222922|OG003|Outcome|PF-06647020 2.1 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204654|NCT02222922|OG004|Outcome|PF-06647020 2.8 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
11204655|NCT02222922|OG005|Outcome|PF-06647020 3.7 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
10804389|NCT03573336|BG000|Baseline|Vilaprisan (BAY1002670) 2 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.
10804390|NCT03573336|BG001|Baseline|Vilaprisan (BAY1002670) 4 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
11204656|NCT02222922|OG000|Outcome|PF-06647020 2.1 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
11204657|NCT02222922|OG001|Outcome|PF-06647020 2.8 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
11204658|NCT02222922|OG002|Outcome|PF-06647020 3.2 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
11204659|NCT02222922|OG000|Outcome|NSCLC - Q3W Regimen|Participants with NSCLC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204660|NCT02222922|OG001|Outcome|OVCA - Q3W Regimen|Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204661|NCT02222922|OG002|Outcome|TNBC - Q3W Regimen|Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204662|NCT02222922|OG000|Outcome|NSCLC - Q3W Regimen|Participants with NSCL received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204663|NCT02222922|OG000|Outcome|PF-06647020 2.8 mg/kg (Q3W-DDI)|Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
11204664|NCT02222922|OG001|Outcome|PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)|Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
11204665|NCT02222922|OG000|Outcome|NSCLC - Q2W Regimen|Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204666|NCT02222922|OG001|Outcome|OVCA - Q2W Regimen|Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
11204667|NCT02222922|EG000|Reported Event|PF-06647020 0.2 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
11204668|NCT02222922|EG001|Reported Event|PF-06647020 0.5 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
11204669|NCT02222922|EG002|Reported Event|PF-06647020 1.25 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
11204670|NCT02222922|EG003|Reported Event|PF-06647020 2.1 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204671|NCT02222922|EG004|Reported Event|PF-06647020 2.8 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
11204672|NCT02222922|EG005|Reported Event|PF-06647020 3.7 mg/kg (Q3W Regimen)|Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
11204673|NCT02222922|EG006|Reported Event|PF-06647020 2.1 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
10804391|NCT03573336|BG002|Baseline|Placebo|Premenopausal women 18 years and older with endometriosis received placebo.
11204674|NCT02222922|EG007|Reported Event|PF-06647020 2.8 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
10804392|NCT03573336|BG003|Baseline|Total|Total of all reporting groups
11204675|NCT02222922|EG008|Reported Event|PF-06647020 3.2 mg/kg (Q2W Regimen)|Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
11204676|NCT02223065|BG000|Baseline|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
11204677|NCT02223065|BG001|Baseline|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
11204678|NCT02223065|BG002|Baseline|Total|Total of all reporting groups
11204679|NCT02223065|FG000|Participant Flow|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
11204680|NCT02223065|FG001|Participant Flow|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
11204681|NCT02223065|OG000|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
11204682|NCT02223065|OG001|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
11204683|NCT02223065|EG000|Reported Event|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
11204684|NCT02223065|EG001|Reported Event|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
11204685|NCT02223260|BG000|Baseline|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
11204686|NCT02223260|FG000|Participant Flow|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
11204687|NCT02223260|OG000|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
11204688|NCT02223260|EG000|Reported Event|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
11204689|NCT02223338|BG000|Baseline|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
11204690|NCT02223338|BG001|Baseline|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
11204691|NCT02223338|BG002|Baseline|Total|Total of all reporting groups
11204692|NCT02223338|FG000|Participant Flow|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
11244069|NCT02508480|EG001|Reported Event|Enhanced Control|"Participants in this arm will attend a 60-minute peer-led group discussion on stigma and discrimination, and be eligible to participate in the 10-week Photovoice program after completing all study assessments.~Enhanced Control: The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session. It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month fo"
11244070|NCT02508636|BG000|Baseline|Combination Therapy: Enzalutamide and Leuprolide|"Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.~Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks."
11244071|NCT02508636|FG000|Participant Flow|Combination Therapy: Enzalutamide and Leuprolide|"Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.~Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks."
11244072|NCT02508636|OG000|Outcome|Combination Therapy: Enzalutamide and Leuprolide|"Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.~Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks."
11244073|NCT02508636|EG000|Reported Event|Combination Therapy: Enzalutamide and Leuprolide|"Enzalutamide: 160 mg (for 40 mg capsules) per day; Oral administration to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months.~Leuprolide: any duration formulation: single 7.5mg intramuscular injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months;"
11244074|NCT02508649|BG000|Baseline|Placebo|Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.
11244075|NCT02508649|BG001|Baseline|Selepressin 2.5 ng/kg/Min|Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.
11244076|NCT02508649|BG002|Baseline|Selepressin 3.75 ng/kg/Min|Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.
11244077|NCT02508649|BG003|Baseline|Selepressin 5.25 ng/kg/Min|Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
11244078|NCT02508649|BG004|Baseline|Total|Total of all reporting groups
11244079|NCT02508649|FG000|Participant Flow|Placebo|Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.
11244080|NCT02508649|FG001|Participant Flow|Selepressin 2.5 ng/kg/Min|Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.
11244081|NCT02508649|FG002|Participant Flow|Selepressin 3.75 ng/kg/Min|Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.
11244082|NCT02508649|FG003|Participant Flow|Selepressin 5.25 ng/kg/Min|Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
11244083|NCT02508649|OG000|Outcome|Placebo|Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.
11244084|NCT02508649|OG001|Outcome|Selepressin Pooled|All selepressin arms pooled together and treated as a single arm.
11244085|NCT02508649|OG001|Outcome|Selepressin 2.5 ng/kg/Min|Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.
11244086|NCT02508649|OG002|Outcome|Selepressin 3.75 ng/kg/Min|Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.
11244087|NCT02508649|OG003|Outcome|Selepressin 5.25 ng/kg/Min|Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
11244088|NCT02508649|OG004|Outcome|Selepressin Pooled|All selepressin arms pooled together and treated as a single arm.
11244089|NCT02508649|EG000|Reported Event|Placebo|Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.
11244090|NCT02508649|EG001|Reported Event|Selepressin 2.5 ng/kg/Min|Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.
11244091|NCT02508649|EG002|Reported Event|Selepressin 3.75 ng/kg/Min|Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.
11244092|NCT02508649|EG003|Reported Event|Selepressin 5.25 ng/kg/Min|Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
11244093|NCT02508649|EG004|Reported Event|Selepressin Pooled|All selepressin arms pooled together and treated as a single arm.
11244094|NCT02508701|BG000|Baseline|Altruistic Inside-dorm|"Altruistic & personal message with direct recommendation and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244095|NCT02508701|BG001|Baseline|Generic Inside-dorm|"Generic message and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244096|NCT02508701|BG002|Baseline|Generic Outside-dorm|"Generic message and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244097|NCT02508701|BG003|Baseline|Altruistic Outside-dorm|"Altruistic & personal message with direct recommendation and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244098|NCT02508701|BG004|Baseline|Total|Total of all reporting groups
11244099|NCT02508701|FG000|Participant Flow|Altruistic Inside-dorm|"Altruistic & personal message with direct recommendation and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244100|NCT02508701|FG001|Participant Flow|Generic Inside-dorm|"Generic message and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244101|NCT02508701|FG002|Participant Flow|Generic Outside-dorm|"Generic message and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244102|NCT02508701|FG003|Participant Flow|Altruistic Outside-dorm|"Altruistic & personal message with direct recommendation and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244103|NCT02508701|OG000|Outcome|Altruistic Inside-dorm|"Altruistic & personal message with direct recommendation and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244104|NCT02508701|OG001|Outcome|Generic Inside-dorm|"Generic message and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244105|NCT02508701|OG002|Outcome|Generic Outside-dorm|"Generic message and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244106|NCT02508701|OG003|Outcome|Altruistic Outside-dorm|"Altruistic & personal message with direct recommendation and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244107|NCT02508701|OG000|Outcome|Altruistic Inside-dorm|"Altruistic & personal message with direct recommendation and access to the vaccine on-site~The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm and provides a direct recommendation to get the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244108|NCT02508701|OG001|Outcome|Generic Inside-dorm|"Generic message and access to the vaccine on-site~The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm but provides no recommendation~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244109|NCT02508701|OG002|Outcome|Generic Outside-dorm|"Generic message and off-site access to the vaccine~The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the health center but provides no recommendation~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244110|NCT02508701|OG003|Outcome|Altruistic Outside-dorm|"Altruistic & personal message with direct recommendation and off-site access to the vaccine~The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the student health center and provides a direct appeal to get the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11244111|NCT02508701|EG000|Reported Event|Altruistic Inside-dorm|"Altruistic & personal message with direct recommendation and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
11204693|NCT02223338|FG001|Participant Flow|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
11204694|NCT02223338|OG000|Outcome|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
11204695|NCT02223338|OG001|Outcome|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
11204696|NCT02223338|EG000|Reported Event|Ciprofloxacin|"Ciprofloxacin:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These patients must have been instructed to use post-injection topical ciprofloxacin 0.3% 4x daily for 3 days. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Ciprofloxacin: Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis."
11204697|NCT02223338|EG001|Reported Event|Standard Aseptic Technique|"Standard Aseptic Technique:~Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.~Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months."
11204698|NCT02223351|BG000|Baseline|400mg ASP2151|ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.
11204699|NCT02223351|BG001|Baseline|1200mg ASP2151|ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.
11204700|NCT02223351|BG002|Baseline|Total|Total of all reporting groups
11204701|NCT02223351|FG000|Participant Flow|400mg ASP2151|ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.
11204702|NCT02223351|FG001|Participant Flow|1200mg ASP2151|ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.
11204703|NCT02223351|OG000|Outcome|400 mg ASP2151 Alone|ASP2151(400 mg) alone
11204704|NCT02223351|OG001|Outcome|400mg ASP2151 With Ritonavir|"400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir~ASP2151~ritonavir"
11204705|NCT02223351|OG002|Outcome|1200 mg ASP2151 Alone|ASP2151(1200 mg) alone
11204706|NCT02223351|OG003|Outcome|1200mg ASP2151 With Ritonavir|"1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir~ASP2151~ritonavir"
11204707|NCT02223351|OG000|Outcome|400 mg ASP2151 Alone|400 mg ASP2151 alone
11204708|NCT02223351|OG001|Outcome|400 mg ASP2151 With Ritonavir|400 mg ASP2151 with 600 mg ritonavir
11204709|NCT02223351|OG002|Outcome|1200 mg ASP2151 Alone|1200 mg ASP2151 alone
11204710|NCT02223351|OG003|Outcome|1200 mg ASP2151 Withritonavir|1200 mg ASP2151 with 600 mg ritonavir
11204711|NCT02223351|EG000|Reported Event|400 mg ASP2151 Alone|400 mg ASP2151 alone
11204712|NCT02223351|EG001|Reported Event|400 mg ASP2151 With Ritonavir|400 mg ASP2151 with 600 mg ritonavir
11204713|NCT02223351|EG002|Reported Event|1200 mg ASP2151 Alone|1200 mg ASP2151 alone
11204714|NCT02223351|EG003|Reported Event|1200 mg ASP2151 With Ritonavir|1200 mg ASP2151 with 600 mg ritonavir
11204715|NCT02223364|BG000|Baseline|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
11204716|NCT02223364|BG001|Baseline|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
10804393|NCT03573336|FG000|Participant Flow|Vilaprisan (BAY1002670) 2 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.
10804394|NCT03573336|FG001|Participant Flow|Vilaprisan (BAY1002670) 4 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
10804395|NCT03573336|FG002|Participant Flow|Placebo|Premenopausal women 18 years and older with endometriosis received placebo.
10804396|NCT03573336|OG000|Outcome|Vilaprisan (BAY1002670) 2 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.
10804397|NCT03573336|OG001|Outcome|Vilaprisan (BAY1002670) 4 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
10804398|NCT03573336|OG002|Outcome|Placebo|Premenopausal women 18 years and older with endometriosis received placebo.
10804399|NCT03573336|EG000|Reported Event|Placebo|Premenopausal women 18 years and older with endometriosis received placebo
10804400|NCT03573336|EG001|Reported Event|Vilaprisan (BAY1002670) 2 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.
10804401|NCT03573336|EG002|Reported Event|Vilaprisan (BAY1002670) 4 mg|Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
10804402|NCT03570697|BG000|Baseline|Placebo|Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804403|NCT03570697|BG001|Baseline|Evolocumab|Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804404|NCT03570697|BG002|Baseline|Total|Total of all reporting groups
10804405|NCT03570697|FG000|Participant Flow|Placebo|Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804406|NCT03570697|FG001|Participant Flow|Evolocumab|Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804407|NCT03570697|OG000|Outcome|Placebo|Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
11244112|NCT02508701|EG001|Reported Event|Generic Inside-dorm|"Generic message and access to the vaccine on-site~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
10804408|NCT03570697|OG001|Outcome|Evolocumab|Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804409|NCT03570697|EG000|Reported Event|Placebo|Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804410|NCT03570697|EG001|Reported Event|Evolocumab|Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
10804411|NCT03548051|BG000|Baseline|FMPE Group|"100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally~A single dose of fecal microbial suspension contains 100 g of stool in 250 mL diluent, comprising 12.5% glycerol and 87.5% sterile normal saline buffer (0.9% NaCl)."
10804412|NCT03548051|BG001|Baseline|FMPP Group|"250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally~The placebo microbiota preparation (FMPP) is formulated with 250 mL sterile Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), 8-12 drops brown food coloring (AmeriColor 204 or similar) and water."
10804413|NCT03548051|BG002|Baseline|Total|Total of all reporting groups
10804414|NCT03548051|FG000|Participant Flow|FMPE Group|"100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally~A single dose of fecal microbial suspension contains 100 g of stool in 250 mL diluent, comprising 12.5% glycerol and 87.5% sterile normal saline buffer (0.9% NaCl)."
10804415|NCT03548051|FG001|Participant Flow|FMPP Group|"250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally~The placebo microbiota preparation (FMPP) is formulated with 250 mL sterile Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), 8-12 drops brown food coloring (AmeriColor 204 or similar) and water."
10804416|NCT03548051|OG000|Outcome|FMPE Group|100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
10804417|NCT03548051|OG001|Outcome|FMPP Group|250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
10804418|NCT03548051|EG000|Reported Event|FMPE Group|100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
10804419|NCT03548051|EG001|Reported Event|FMPP Group|250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
10820460|NCT00058058|EG000|Reported Event|MRI Evaluation of Contralateral Breast|"The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.~MRI: Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study."
10820461|NCT00058123|BG000|Baseline|Poly-ICLC Recurrent Gliomas|"Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)~Intramuscular injection~poly ICLC"
10820462|NCT00058123|FG000|Participant Flow|Poly-ICLC Recurrent Gliomas|"Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)~Intramuscular injection~poly ICLC"
10820463|NCT00058123|OG000|Outcome|Poly-ICLC Recurrent Gliomas|"Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
10820464|NCT00058123|OG000|Outcome|Poly-ICLC Recurrent Gliomas|"Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)~Intramuscular injection~poly ICLC"
10820465|NCT00058123|EG000|Reported Event|Poly-ICLC Recurrent Gliomas|"Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)~Intramuscular injection~poly ICLC"
11204717|NCT02223364|BG002|Baseline|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
11204718|NCT02223364|BG003|Baseline|Total|Total of all reporting groups
11204719|NCT02223364|FG000|Participant Flow|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
11204720|NCT02223364|FG001|Participant Flow|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
11204721|NCT02223364|FG002|Participant Flow|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
11204722|NCT02223364|OG000|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
11204723|NCT02223364|OG001|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
10804420|NCT03525886|BG000|Baseline|Cohort 1 (50 mg QHS)|NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
11244113|NCT02508701|EG002|Reported Event|Generic Outside-dorm|"Generic message and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
10804421|NCT03525886|BG001|Baseline|Cohort 2 (100 mg QHS)|NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804422|NCT03525886|BG002|Baseline|Cohort 3 (100 mg QPM)|NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
10804423|NCT03525886|BG003|Baseline|Cohort 4 (100 mg BID)|NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
10804424|NCT03525886|BG004|Baseline|Total|Total of all reporting groups
10804425|NCT03525886|FG000|Participant Flow|Cohort 1 (50 mg QHS)|NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804426|NCT03525886|FG001|Participant Flow|Cohort 2 (100 mg QHS)|NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804427|NCT03525886|FG002|Participant Flow|Cohort 3 (100 mg QPM)|NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
10804428|NCT03525886|FG003|Participant Flow|Cohort 4 (100 mg BID)|NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
11204724|NCT02223364|OG002|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
11204725|NCT02223364|EG000|Reported Event|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
11204726|NCT02223364|EG001|Reported Event|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
10804429|NCT03525886|OG000|Outcome|Cohort 1 (50 mg QHS)|NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804430|NCT03525886|OG001|Outcome|Cohort 2 (100 mg QHS)|NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804431|NCT03525886|OG002|Outcome|Cohort 3 (100 mg QPM)|NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
10804432|NCT03525886|OG003|Outcome|Cohort 4 (100 mg BID)|NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
10804433|NCT03525886|EG000|Reported Event|Cohort 1 (50 mg QHS)|NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804434|NCT03525886|EG001|Reported Event|Cohort 2 (100 mg QHS)|NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
10804435|NCT03525886|EG002|Reported Event|Cohort 3 (100 mg QPM)|NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
10804436|NCT03525886|EG003|Reported Event|Cohort 4 (100 mg BID)|NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
10804437|NCT03503318|BG000|Baseline|Placebo|Participants received an SC injection of placebo matched to TV-46000 at baseline and q4w thereafter. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804438|NCT03503318|BG001|Baseline|TV-46000 q1m|Participants received an SC injection of TV-46000 at baseline and q4w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804439|NCT03503318|BG002|Baseline|TV-46000 q2m|Participants received an SC injection of TV-46000 at baseline and q8w thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804440|NCT03503318|BG003|Baseline|Total|Total of all reporting groups
10804441|NCT03503318|FG000|Participant Flow|Placebo|Participants received an SC injection of placebo matched to TV-46000 at baseline and every 4 weeks (q4w) thereafter. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804442|NCT03503318|FG001|Participant Flow|TV-46000 q1m|Participants received an SC injection of TV-46000 at baseline and q4w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804443|NCT03503318|FG002|Participant Flow|TV-46000 q2m|Participants received an SC injection of TV-46000 at baseline and every 8 weeks (q8w) thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
11244114|NCT02508701|EG003|Reported Event|Altruistic Outside-dorm|"Altruistic & personal message with direct recommendation and off-site access to the vaccine~Message X Onsite/Offsite Vaccination: Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination"
10804444|NCT03503318|OG000|Outcome|Placebo|Participants received an SC injection of placebo matched to TV-46000 at baseline and q4w thereafter. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804445|NCT03503318|OG001|Outcome|TV-46000 q1m|Participants received an SC injection of TV-46000 at baseline and q4w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804446|NCT03503318|OG002|Outcome|TV-46000 q2m|Participants received an SC injection of TV-46000 at baseline and q8w thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804447|NCT03503318|EG000|Reported Event|Placebo|Participants received an SC injection of placebo matched to TV-46000 at baseline and q4w thereafter. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804448|NCT03503318|EG001|Reported Event|TV-46000 q1m|Participants received an SC injection of TV-46000 at baseline and q4w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804449|NCT03503318|EG002|Reported Event|TV-46000 q2m|Participants received an SC injection of TV-46000 at baseline and q8w thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter. The maximal dose administered to adult participants was comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents was comparable to 4 mg/day. Participants continued treatment until they experienced a relapse event; met 1 or more of the study discontinuation or withdrawal criteria; or remained relapse-free during the double-blind phase until the study was terminated.
10804450|NCT03493854|BG000|Baseline|Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
10820466|NCT00058214|BG000|Baseline|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
11204727|NCT02223364|EG002|Reported Event|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
11204728|NCT02223390|BG000|Baseline|Mental Health Treatment|"The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.~Improving AIDS Care after Trauma (ImpACT)"
11204729|NCT02223390|BG001|Baseline|Standard of Care|Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
11204730|NCT02223390|BG002|Baseline|Total|Total of all reporting groups
11204731|NCT02223390|FG000|Participant Flow|Mental Health Treatment|"The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.~Improving AIDS Care after Trauma (ImpACT)"
11204732|NCT02223390|FG001|Participant Flow|Standard of Care|Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
11204733|NCT02223390|OG000|Outcome|Mental Health Treatment|"The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.~Improving AIDS Care after Trauma (ImpACT)"
11204734|NCT02223390|OG001|Outcome|Standard of Care|Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
11244115|NCT02508935|BG000|Baseline|XARTEMIS XR|XARTEMIS XR is a combination of oxycodone and acetaminophen administered to postsurgical adolescent participants with moderate to severe acute pain.
11244116|NCT02508935|FG000|Participant Flow|XARTEMIS XR|XARTEMIS XR is a combination of oxycodone and acetaminophen administered to postsurgical adolescent participants with moderate to severe acute pain.
11244117|NCT02508935|OG000|Outcome|XARTEMIS XR|"All participants received XARTEMIS XR~XARTEMIS XR: XARTEMIS XR (7.5 mg oxycodone hydrochloride and 325 mg acetaminophen) Extended-Release Tablets"
11244118|NCT02508935|OG000|Outcome|Oxycodone|Pharmacokinetics of oxycodone were collected for 12 hours after dosing of XARTEMIS XR on Study Day 1
10804451|NCT03493854|BG001|Baseline|Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
10804452|NCT03493854|BG002|Baseline|Total|Total of all reporting groups
10804453|NCT03493854|FG000|Participant Flow|Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
10804454|NCT03493854|FG001|Participant Flow|Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
10804455|NCT03493854|OG000|Outcome|Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
10804456|NCT03493854|OG001|Outcome|Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
10804457|NCT03493854|EG000|Reported Event|Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
10804458|NCT03493854|EG001|Reported Event|Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy|Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
10804459|NCT03493451|BG000|Baseline|Cohort 1: ENKTL|Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804460|NCT03493451|BG001|Baseline|Cohort 2: PTCL-NOS, AITL, and ALCL|Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804461|NCT03493451|BG002|Baseline|Cohort 3: MF and SS|Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
11244119|NCT02508935|OG001|Outcome|Acetaminophen|Pharmacokinetics of acetaminophen were collected for 12 hours after dosing of XARTEMIS XR on Study Day 1
11244120|NCT02508935|EG000|Reported Event|XARTEMIS XR|XARTEMIS XR is a combination of oxycodone and acetaminophen administered to postsurgical adolescent participants with moderate to severe acute pain.
10804462|NCT03493451|BG003|Baseline|Total|Total of all reporting groups
10804463|NCT03493451|FG000|Participant Flow|Cohort 1: ENKTL|Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804464|NCT03493451|FG001|Participant Flow|Cohort 2: PTCL-NOS, AITL, and ALCL|Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804465|NCT03493451|FG002|Participant Flow|Cohort 3: MF and SS|Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804466|NCT03493451|OG000|Outcome|Cohort 1: ENKTL|Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804467|NCT03493451|OG001|Outcome|Cohort 2: PTCL-NOS, AITL, and ALCL|Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804468|NCT03493451|OG002|Outcome|Cohort 3: MF and SS|Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804469|NCT03493451|EG000|Reported Event|Cohort 1: ENKTL|Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804470|NCT03493451|EG001|Reported Event|Cohort 2: PTCL-NOS, AITL, and ALCL|Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804471|NCT03493451|EG002|Reported Event|Cohort 3: MF and SS|Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
10804472|NCT03476239|BG000|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. Treatment consisted of two induction cycles and up to 3 consolidation cycles of treatment for responders.~In the first induction cycle, the initial dose of blinatumomab was 9 μg/day for days 1-7 and then escalated (dose step) to 28 μg/day starting on day 8 (week 2) through day 29 (week 4), followed by two weeks without blinatumomab treatment.~In subsequent cycles (beginning with the second induction cycle and continuing through consolidation, for applicable participants) 28 μg/day was administered for all 4 weeks of continuous treatment, followed by a treatment-free interval of two weeks."
10804473|NCT03476239|FG000|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. Treatment consisted of two induction cycles and up to 3 consolidation cycles of treatment for responders.~In the first induction cycle, the initial dose of blinatumomab was 9 μg/day for days 1-7 and then escalated (dose step) to 28 μg/day starting on day 8 (week 2) through day 29 (week 4), followed by two weeks without blinatumomab treatment.~In subsequent cycles (beginning with the second induction cycle and continuing through consolidation, for applicable participants) 28 μg/day was administered for all 4 weeks of continuous treatment, followed by a treatment-free interval of two weeks."
10804474|NCT03476239|OG000|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. Treatment consisted of two induction cycles and up to 3 consolidation cycles of treatment for responders.~In the first induction cycle, the initial dose of blinatumomab was 9 μg/day for days 1-7 and then escalated (dose step) to 28 μg/day starting on day 8 (week 2) through day 29 (week 4), followed by two weeks without blinatumomab treatment.~In subsequent cycles (beginning with the second induction cycle and continuing through consolidation, for applicable participants) 28 μg/day was administered for all 4 weeks of continuous treatment, followed by a treatment-free interval of two weeks."
10804475|NCT03476239|EG000|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. Treatment consisted of two induction cycles and up to 3 consolidation cycles of treatment for responders.~In the first induction cycle, the initial dose of blinatumomab was 9 μg/day for days 1-7 and then escalated (dose step) to 28 μg/day starting on day 8 (week 2) through day 29 (week 4), followed by two weeks without blinatumomab treatment.~In subsequent cycles (beginning with the second induction cycle and continuing through consolidation, for applicable participants) 28 μg/day was administered for all 4 weeks of continuous treatment, followed by a treatment-free interval of two weeks."
10804476|NCT03431168|BG000|Baseline|Azithromycin/TMPS|"Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
11244121|NCT02509026|BG000|Baseline|Etanercept|All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level < 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level >= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
11204735|NCT02223390|EG000|Reported Event|Mental Health Treatment|"The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.~Improving AIDS Care after Trauma (ImpACT)"
11204736|NCT02223390|EG001|Reported Event|Standard of Care|Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
11204737|NCT02223429|BG000|Baseline|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
11204738|NCT02223429|BG001|Baseline|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
11204739|NCT02223429|BG002|Baseline|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
11204740|NCT02223429|BG003|Baseline|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
11204741|NCT02223429|BG004|Baseline|Total|Total of all reporting groups
11204742|NCT02223429|FG000|Participant Flow|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
11204743|NCT02223429|FG001|Participant Flow|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
11204744|NCT02223429|FG002|Participant Flow|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
11204745|NCT02223429|FG003|Participant Flow|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
11204746|NCT02223429|OG000|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
11204747|NCT02223429|OG001|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
11204748|NCT02223429|OG000|Outcome|AVP + Placebo|The AVP + placebo group self-administered no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received AVP first, and half received AVP second.
11204749|NCT02223429|OG000|Outcome|OT + Placebo Group|The OT + placebo group self-administered no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received OT first, and half received OT second.
11204750|NCT02223429|OG000|Outcome|Oxytocin|All participants who were administered oxytocin at any time point during the study and have completed the cry rating scale.
10804477|NCT03431168|BG001|Baseline|Placebo/TMPS|"Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804478|NCT03431168|BG002|Baseline|Total|Total of all reporting groups
10804479|NCT03431168|FG000|Participant Flow|Azithromycin/TMPS|"Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804480|NCT03431168|FG001|Participant Flow|Placebo/TMPS|"Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804481|NCT03431168|OG000|Outcome|Azithromycin/TMPS|"Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804482|NCT03431168|OG001|Outcome|Placebo/TMPS|"Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804483|NCT03431168|EG000|Reported Event|Azithromycin/TMPS|"Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804484|NCT03431168|EG001|Reported Event|Placebo/TMPS|"Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.~TMPS double strength 1 tablet po daily.~Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit"
10804485|NCT03401749|BG000|Baseline|Control Group|Usual preadmission surgery instructions (shower the night before).
10804486|NCT03401749|BG001|Baseline|Theraworx Group|"Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.~Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6."
10804487|NCT03401749|BG002|Baseline|CHG Group|"Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.~Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery."
10804488|NCT03401749|BG003|Baseline|Total|Total of all reporting groups
10804489|NCT03401749|FG000|Participant Flow|Control Group|Usual preadmission surgery instructions (shower the night before).
10804490|NCT03401749|FG001|Participant Flow|Theraworx Group|"Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.~Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6."
10804491|NCT03401749|FG002|Participant Flow|CHG Group|"Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.~Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery."
11204751|NCT02223429|OG001|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
11204752|NCT02223429|OG000|Outcome|Vasopressin (AVP)|All participants who were administered AVP at any time point during the study and have completed the cry rating scale.
11204753|NCT02223429|OG000|Outcome|Vasopressin (AVP)|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
10804492|NCT03401749|OG000|Outcome|Control Group|Usual preadmission surgery instructions (shower the night before).
10967028|NCT00891046|BG002|Baseline|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11204754|NCT02223429|OG001|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
10804493|NCT03401749|OG001|Outcome|Theraworx Group|"Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.~Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6."
10804494|NCT03401749|OG002|Outcome|CHG Group|"Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.~Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery."
10804495|NCT03401749|EG000|Reported Event|Control Group|Usual preadmission surgery instructions (shower the night before).
10804496|NCT03401749|EG001|Reported Event|Theraworx Group|"Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.~Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6."
10804497|NCT03401749|EG002|Reported Event|CHG Group|"Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.~Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery."
10804498|NCT03337113|BG000|Baseline|WMT + rTMS|"WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804499|NCT03337113|BG001|Baseline|Sham WMT + rTMS|"Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804500|NCT03337113|BG002|Baseline|WMT + Sham rTMS|"WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804501|NCT03337113|BG003|Baseline|Sham WMT + Sham rTMS|"sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804502|NCT03337113|BG004|Baseline|Total|Total of all reporting groups
11204755|NCT02223429|EG000|Reported Event|OT Treatment|"The OT group self-administered no more than 1 ml solution of oxytocin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of OT treatment."
11204756|NCT02223429|EG001|Reported Event|AVP Treatment|"The AVP group self-administered no more than 1 ml solution of vasopressin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of AVP treatment."
10804503|NCT03337113|FG000|Participant Flow|WMT + rTMS|"WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804504|NCT03337113|FG001|Participant Flow|Sham WMT + rTMS|"Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804505|NCT03337113|FG002|Participant Flow|WMT + Sham rTMS|"WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804506|NCT03337113|FG003|Participant Flow|Sham WMT + Sham rTMS|"sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804507|NCT03337113|OG000|Outcome|WMT + rTMS|"WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10820467|NCT00058214|FG000|Participant Flow|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
11204757|NCT02223429|EG002|Reported Event|Placebo of OT|"The placebo of OT group self-administered no more than 1 ml solution of placebo of OT in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the OT treatment."
11204758|NCT02223429|EG003|Reported Event|Placebo of AVP|"The placebo of AVP group self-administered no more than 1 ml solution of placebo of AVP in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the AVP treatment."
10804508|NCT03337113|OG001|Outcome|Sham WMT + rTMS|"Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804509|NCT03337113|OG002|Outcome|WMT + Sham rTMS|"WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804510|NCT03337113|OG003|Outcome|Sham WMT + Sham rTMS|"sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804511|NCT03337113|EG000|Reported Event|WMT + rTMS|"WMT + rTMS is the Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. Both conditions are active.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10804512|NCT03337113|EG001|Reported Event|Sham WMT + rTMS|"Sham WMT + rTMS is the sham Working Memory Training + repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of rTMS. WMT is inactive.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~repetitive Transcranial Magnetic Stimulation: The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
10820468|NCT00058214|OG000|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
11204759|NCT02223455|BG000|Baseline|Single Hand Hygiene Sign|"Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204760|NCT02223455|BG001|Baseline|Hand Hygiene Signs Changed Monthly|"Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
10804513|NCT03337113|EG002|Reported Event|WMT + Sham rTMS|"WMT + sham rTMS is the Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. This condition isolates the effects of WMT. rTMS is inactive.~Working Memory Training: The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10804514|NCT03337113|EG003|Reported Event|Sham WMT + Sham rTMS|"sham WMT + sham rTMS is the sham Working Memory Training + sham repetitive Transcranial Magnetic Stimulation arm. Both are inactive in this arm.~Sham Working Memory Training: In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.~Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation."
10820469|NCT00058214|EG000|Reported Event|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
10820470|NCT00058240|BG000|Baseline|Dose Level 1|Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
10820471|NCT00058240|BG001|Baseline|Dose Level 2|Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
10820472|NCT00058240|BG002|Baseline|Dose Level 3|Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820473|NCT00058240|BG003|Baseline|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820474|NCT00058240|BG004|Baseline|Total|Total of all reporting groups
10820475|NCT00058240|FG000|Participant Flow|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
10820476|NCT00058240|FG001|Participant Flow|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
11204761|NCT02223455|BG002|Baseline|Hand Hygiene Signs Changed Weekly|"Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204762|NCT02223455|BG003|Baseline|Total|Total of all reporting groups
11204763|NCT02223455|FG000|Participant Flow|Single Hand Hygiene Sign|"Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
10820477|NCT00058240|FG002|Participant Flow|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820478|NCT00058240|FG003|Participant Flow|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820479|NCT00058240|OG000|Outcome|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
10820480|NCT00058240|OG001|Outcome|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
10820481|NCT00058240|OG002|Outcome|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820482|NCT00058240|OG003|Outcome|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820483|NCT00058240|OG000|Outcome|Dose Level 4|Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
10967029|NCT00891046|BG003|Baseline|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10804515|NCT03257631|BG000|Baseline|Diffuse Intrinsic Pontine Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804516|NCT03257631|BG001|Baseline|Ependymoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804517|NCT03257631|BG002|Baseline|High-grade Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804518|NCT03257631|BG003|Baseline|Medulloblastoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804519|NCT03257631|BG004|Baseline|Total|Total of all reporting groups
10804520|NCT03257631|FG000|Participant Flow|Diffuse Intrinsic Pontine Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804521|NCT03257631|FG001|Participant Flow|Ependymoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804522|NCT03257631|FG002|Participant Flow|High-grade Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804523|NCT03257631|FG003|Participant Flow|Medulloblastoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804524|NCT03257631|OG000|Outcome|Diffuse Intrinsic Pontine Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804525|NCT03257631|OG001|Outcome|Ependymoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804526|NCT03257631|OG002|Outcome|High-grade Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804527|NCT03257631|OG003|Outcome|Medulloblastoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804528|NCT03257631|EG000|Reported Event|Diffuse Intrinsic Pontine Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804529|NCT03257631|EG001|Reported Event|Ependymoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804530|NCT03257631|EG002|Reported Event|High-grade Glioma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804531|NCT03257631|EG003|Reported Event|Medulloblastoma|Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
10804532|NCT03253796|BG000|Baseline|Open-Label Run-In Golimumab QM|Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.
10804533|NCT03253796|BG001|Baseline|Golimumab QM (Full Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804534|NCT03253796|BG002|Baseline|Golimumab Q2M (Reduced Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804535|NCT03253796|BG003|Baseline|Placebo (Treatment Withdrawal Regimen)|Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804536|NCT03253796|BG004|Baseline|Open-Label Retreatment|Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804537|NCT03253796|BG005|Baseline|Total|Total of all reporting groups
10804538|NCT03253796|FG000|Participant Flow|Open-Label Run-In Golimumab QM|Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.
10804539|NCT03253796|FG001|Participant Flow|Golimumab QM (Full Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804540|NCT03253796|FG002|Participant Flow|Golimumab Q2M (Reduced Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804541|NCT03253796|FG003|Participant Flow|Placebo (Treatment Withdrawal Regimen)|Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804542|NCT03253796|FG004|Participant Flow|Open-Label Retreatment|Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804543|NCT03253796|OG000|Outcome|Golimumab QM (Full Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804544|NCT03253796|OG001|Outcome|Golimumab Q2M (Reduced Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804545|NCT03253796|OG002|Outcome|Placebo (Treatment Withdrawal Regimen)|Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804546|NCT03253796|OG000|Outcome|Open-Label Retreatment|Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804547|NCT03253796|OG000|Outcome|Golimumab QM (Full Treatment Regimen)|"Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.~Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab."
10804548|NCT03253796|OG003|Outcome|Open-Label Retreatment|Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804549|NCT03253796|OG000|Outcome|Golimumab QM (Full Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804550|NCT03253796|OG001|Outcome|Golimumab Q2M and Placebo (Withdrawal Regimens)|Participants were treated with double-blinded SC injections of 50 mg golimumab Q2M alternating with matching placebo to golimumab every other month or with placebo for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804551|NCT03253796|EG000|Reported Event|Open-Label Run-In Golimumab QM|Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.
10804552|NCT03253796|EG001|Reported Event|Golimumab QM (Full Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10847540|NCT00283712|FG001|Participant Flow|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
11286156|NCT02884427|EG001|Reported Event|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.~Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
10804553|NCT03253796|EG002|Reported Event|Golimumab Q2M (Reduced Treatment Regimen)|Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804554|NCT03253796|EG003|Reported Event|Placebo (Treatment Withdrawal Regimen)|Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
10804555|NCT03253796|EG004|Reported Event|Open-Label Retreatment|Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
10804556|NCT03233048|BG000|Baseline|ORBERA™ Intragastric Balloon|"Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.~ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed."
10804557|NCT03233048|FG000|Participant Flow|ORBERA™ Intragastric Balloon|"Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.~ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed."
10804558|NCT03233048|OG000|Outcome|ORBERA™ Intragastric Balloon|"Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.~ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed."
10804559|NCT03233048|EG000|Reported Event|ORBERA™ Intragastric Balloon|"Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.~ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed."
10804560|NCT03138252|BG000|Baseline|Cervical Ripening Balloon Alone|"Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804561|NCT03138252|BG001|Baseline|Cervical Ripening Balloon + Oxytocin|"Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804562|NCT03138252|BG002|Baseline|Total|Total of all reporting groups
10804563|NCT03138252|FG000|Participant Flow|Cervical Ripening Balloon Alone|"Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804564|NCT03138252|FG001|Participant Flow|Cervical Ripening Balloon + Oxytocin|"Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804565|NCT03138252|OG000|Outcome|Cervical Ripening Balloon Alone|"Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804566|NCT03138252|OG001|Outcome|Cervical Ripening Balloon + Oxytocin|"Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804567|NCT03138252|EG000|Reported Event|Cervical Ripening Balloon Alone|"Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804568|NCT03138252|EG001|Reported Event|Cervical Ripening Balloon + Oxytocin|"Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.~Oxytocin"
10804569|NCT03116399|BG000|Baseline|PRISM 2.0 Condition|"Exposing participants to the PRISM 2.0 interface.~PRISM 2.0 Condition: Access to the PRISM 2.0 program"
10804570|NCT03116399|BG001|Baseline|Tablet Condition|"Exposing participants to the regular computer/tablet~Tablet Condition: Access to the tablet"
10804571|NCT03116399|BG002|Baseline|Total|Total of all reporting groups
10804572|NCT03116399|FG000|Participant Flow|PRISM 2.0 Condition|"Exposing participants to the PRISM 2.0 interface.~PRISM 2.0 Condition: Access to the PRISM 2.0 program"
10804573|NCT03116399|FG001|Participant Flow|Tablet Condition|"Exposing participants to the regular computer/tablet~Tablet Condition: Access to the tablet"
10804574|NCT03116399|OG000|Outcome|PRISM 2.0 Condition|"Exposing participants to the PRISM 2.0 interface.~PRISM 2.0 Condition: Access to the PRISM 2.0 program"
10804575|NCT03116399|OG001|Outcome|Tablet Condition|"Exposing participants to the regular computer/tablet~Tablet Condition: Access to the tablet"
10804576|NCT03116399|EG000|Reported Event|PRISM 2.0 Condition|"Exposing participants to the PRISM 2.0 interface.~PRISM 2.0 Condition: Access to the PRISM 2.0 program"
10804577|NCT03116399|EG001|Reported Event|Tablet Condition|"Exposing participants to the regular computer/tablet~Tablet Condition: Access to the tablet"
10804578|NCT03064126|BG000|Baseline|RANGER™ Paclitaxel Coated Balloon RCT|RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
10804579|NCT03064126|BG001|Baseline|Standard Balloon Angioplasty RCT|Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
10804580|NCT03064126|BG002|Baseline|Long Balloon (LB) Substudy|The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
10804581|NCT03064126|BG003|Baseline|Pharmacokinetics (PK) Substudy|The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
10804582|NCT03064126|BG004|Baseline|Total|Total of all reporting groups
10804583|NCT03064126|FG000|Participant Flow|RANGER™ Paclitaxel Coated Balloon RCT|"RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.~Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.~RANGER™ Paclitaxel Coated Balloon: A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.~Paclitaxel: The RANGER™ Balloon is coated with the drug Paclitaxel."
10804584|NCT03064126|FG001|Participant Flow|Standard Balloon Angioplasty RCT|"Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.~Standard Balloon Angioplasty: A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries."
10804585|NCT03064126|FG002|Participant Flow|Long Balloon (LB) Substudy|The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
10804586|NCT03064126|FG003|Participant Flow|Pharmacokinetics (PK) Substudy|The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
10804587|NCT03064126|OG000|Outcome|RANGER™ Paclitaxel Coated Balloon RCT|RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
10804588|NCT03064126|OG001|Outcome|Standard Balloon Angioplasty RCT|Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
10804589|NCT03064126|OG002|Outcome|Long Balloon (LB) Substudy|"The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.~Primary safety and effectiveness endpoints for the LB Substudy are assessed at 6 months post-procedure."
10804590|NCT03064126|OG003|Outcome|Pharmacokinetics (PK) Substudy|The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
10804591|NCT03064126|OG002|Outcome|Long Balloon (LB) Substudy|The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
10804592|NCT03064126|EG000|Reported Event|RANGER™ Paclitaxel Coated Balloon|RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
10804593|NCT03064126|EG001|Reported Event|Standard Balloon Angioplasty|Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
11204764|NCT02223455|FG001|Participant Flow|Hand Hygiene Signs Changed Monthly|"Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
10804594|NCT03064126|EG002|Reported Event|Long Balloon (LB) Substudy|The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
10804595|NCT03064126|EG003|Reported Event|Pharmacokinetics (PK) Substudy|The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
10804596|NCT03020160|BG000|Baseline|Emicizumab: PK Run-In Part|Participants will received SC emicizumab at a dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804597|NCT03020160|BG001|Baseline|Emicizumab: Expansion Part|Participants will received SC emicizumab at a loading dose of 3 mg/kg every week for initial 4 weeks followed by a maintenance dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804598|NCT03020160|BG002|Baseline|Total|Total of all reporting groups
10804599|NCT03020160|FG000|Participant Flow|Emicizumab: PK Run-In Part|Participants will received SC emicizumab at a dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804600|NCT03020160|FG001|Participant Flow|Emicizumab: Expansion Part|Participants will received SC emicizumab at a loading dose of 3 mg/kg every week for initial 4 weeks followed by a maintenance dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804601|NCT03020160|OG000|Outcome|Emicizumab: Expansion Part|Participants will received SC emicizumab at a loading dose of 3 mg/kg every week for initial 4 weeks followed by a maintenance dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804602|NCT03020160|OG000|Outcome|Emicizumab: PK Run-In Part|Participants will received SC emicizumab at a dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804603|NCT03020160|OG001|Outcome|Emicizumab: Expansion Part|Participants will received SC emicizumab at a loading dose of 3 mg/kg every week for initial 4 weeks followed by a maintenance dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804604|NCT03020160|EG000|Reported Event|Emicizumab: PK Run-In Part|Participants will received SC emicizumab at a dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804605|NCT03020160|EG001|Reported Event|Emicizumab: Expansion Part|Participants will received SC emicizumab at a loading dose of 3 mg/kg every week for initial 4 weeks followed by a maintenance dose of 6 mg/kg every 4 weeks for a minimum of 24 weeks.
10804606|NCT02943993|BG000|Baseline|ETNA-VTE|Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
10804607|NCT02943993|FG000|Participant Flow|ETNA-VTE|Participants with established initial or recurrent acute symptomatic venous thromboembolism (VTE) who were treated with edoxaban according to the Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
10804608|NCT02943993|OG000|Outcome|ETNA-VTE|Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
10804609|NCT02943993|EG000|Reported Event|ETNA-VTE|Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
10804610|NCT02939989|BG000|Baseline|Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks|Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
10804611|NCT02939989|BG001|Baseline|Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks|Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
10804612|NCT02939989|BG002|Baseline|Total|Total of all reporting groups
10804613|NCT02939989|FG000|Participant Flow|Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks|Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
10804614|NCT02939989|FG001|Participant Flow|Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks|Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
10804615|NCT02939989|OG000|Outcome|Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks|Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
10804616|NCT02939989|OG001|Outcome|Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks|Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
10804617|NCT02939989|OG002|Outcome|Total|Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
10804618|NCT02939989|EG000|Reported Event|GLE/PIB + SOF + RBV for 12 Weeks|Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
11204765|NCT02223455|FG002|Participant Flow|Hand Hygiene Signs Changed Weekly|"Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
10804619|NCT02939989|EG001|Reported Event|GLE/PIB + SOF + RBV for 16 Weeks|Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
10804620|NCT02939989|EG002|Reported Event|Total|Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
10804636|NCT02877134|BG000|Baseline|Part I: Placebo|Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) from Week 12 through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22.
10804637|NCT02877134|BG001|Baseline|Part I: JNJ-64304500|Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22.
10804638|NCT02877134|BG002|Baseline|Part II: Placebo|Participants received placebo SC at Weeks 0, 2, 4, 6, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20.
10804639|NCT02877134|BG003|Baseline|Part II: JNJ-64304500 Low Dose|Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20.
10804640|NCT02877134|BG004|Baseline|Part II: JNJ-64304500 Middle Dose|Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20.
10804641|NCT02877134|BG005|Baseline|Part II: JNJ-64304500 High Dose|Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20.
10804642|NCT02877134|BG006|Baseline|Part II: Ustekinumab|Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight [less than or equal to [<=] 55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). - Ustekinumab 520 mg (weight > 85 kg).
10804643|NCT02877134|BG007|Baseline|Total|Total of all reporting groups
11204766|NCT02223455|OG000|Outcome|Single Hand Hygiene Sign|"Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.~Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204767|NCT02223455|OG001|Outcome|Hand Hygiene Signs Changed Monthly|"Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204768|NCT02223455|OG002|Outcome|Hand Hygiene Signs Changed Weekly|"Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Compliance Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204769|NCT02223455|EG000|Reported Event|Single Hand Hygiene Sign|"Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204770|NCT02223455|EG001|Reported Event|Hand Hygiene Signs Changed Monthly|"Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
11204771|NCT02223455|EG002|Reported Event|Hand Hygiene Signs Changed Weekly|"Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.~Hand Hygiene Signs: Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room."
10804644|NCT02877134|FG000|Participant Flow|Part I: Placebo|Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) from Week 12 through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22.
10804645|NCT02877134|FG001|Participant Flow|Part I: JNJ-64304500|Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22.
10804646|NCT02877134|FG002|Participant Flow|Part II: Placebo|Participants received placebo SC at Weeks 0, 2, 4, 6, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20.
10804647|NCT02877134|FG003|Participant Flow|Part II: JNJ-64304500 Low Dose|Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20.
10804648|NCT02877134|FG004|Participant Flow|Part II: JNJ-64304500 Middle Dose|Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20.
10804649|NCT02877134|FG005|Participant Flow|Part II: JNJ-64304500 High Dose|Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20.
10804650|NCT02877134|FG006|Participant Flow|Part II: Ustekinumab|Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight [less than or equal to [<=] 55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). - Ustekinumab 520 mg (weight > 85 kg).
10804651|NCT02877134|OG000|Outcome|Part I: Placebo|Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) from Week 12 through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22.
10804652|NCT02877134|OG001|Outcome|Part I: JNJ-64304500|Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22.
10804653|NCT02877134|OG000|Outcome|Part II: Placebo|Participants received placebo SC at Weeks 0, 2, 4, 6, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20.
10804654|NCT02877134|OG001|Outcome|Part II: JNJ-64304500 Low Dose|Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20.
10804655|NCT02877134|OG002|Outcome|Part II: JNJ-64304500 Middle Dose|Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20.
10804656|NCT02877134|OG003|Outcome|Part II: JNJ-64304500 High Dose|Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20.
10804657|NCT02877134|OG004|Outcome|Part II: Ustekinumab|Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight [less than or equal to [<=] 55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). - Ustekinumab 520 mg (weight > 85 kg).
10804658|NCT02877134|EG000|Reported Event|Part I: Placebo|Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12.
10804659|NCT02877134|EG001|Reported Event|Part I: Placebo to JNJ-64304500|Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ-64304500 at Week 12 onward.
11204772|NCT02223546|BG000|Baseline|Healthy Subject|healthy subject, every 3 hour measurement
11204773|NCT02223546|FG000|Participant Flow|Healthy Subject|healthy subject, every 3 hour measurement
11204774|NCT02223546|OG000|Outcome|Healthy Subject|healthy subject, every 3 hour measurement
11204775|NCT02223546|EG000|Reported Event|Healthy Subject|healthy subject, every 3 hour measurement
11204776|NCT02223637|BG000|Baseline|Exposure Group|Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
11204777|NCT02223637|FG000|Participant Flow|Exposure Group|Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
11204778|NCT02223637|OG000|Outcome|Live Births Group|All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
11204779|NCT02223637|OG000|Outcome|Exposure Group|Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
11204780|NCT02223637|EG000|Reported Event|Exposure Group|Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
11204781|NCT02223650|BG000|Baseline|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
11204782|NCT02223650|BG001|Baseline|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
11204783|NCT02223650|BG002|Baseline|Total|Total of all reporting groups
11204784|NCT02223650|FG000|Participant Flow|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
11204785|NCT02223650|FG001|Participant Flow|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
10804660|NCT02877134|EG002|Reported Event|Part I: JNJ- 64304500|Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22.
10804661|NCT02877134|EG003|Reported Event|Part II: Placebo|Participants received placebo SC at Weeks 0, 2, 4, 6, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12.
10804662|NCT02877134|EG004|Reported Event|Part II: Placebo to JNJ-64304500 Middle Dose|Participants received placebo SC at Weeks 0, 2, 4, 6, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ-64304500 at Week 12 onward.
10804663|NCT02877134|EG005|Reported Event|Part II: JNJ-64304500 Low Dose|Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20.
10804664|NCT02877134|EG006|Reported Event|Part II: JNJ-64304500 Middle Dose|Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20.
10804665|NCT02877134|EG007|Reported Event|Part II: JNJ-64304500 High Dose|Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20.
10804666|NCT02877134|EG008|Reported Event|Part II: Ustekinumab|Participants received Ustekinumab (tiered doses approximating 6 milligrams per kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight less than or equal to [<=]55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). - Ustekinumab 520 mg (weight greater than [>]85 kg).
10820484|NCT00058240|OG000|Outcome|Dose Level 1, 2, 3, 4|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
10820485|NCT00058240|EG000|Reported Event|Dose Levels 1-3|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
10820486|NCT00058240|EG001|Reported Event|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
10820487|NCT00058370|BG000|Baseline|Histologic Proof of Medulloblastoma|This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
10820488|NCT00058370|FG000|Participant Flow|Histologic Proof of Medulloblastoma|This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
10820489|NCT00058370|OG000|Outcome|Histologic Proof of Medulloblastoma|This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
10820490|NCT00058370|EG000|Reported Event|Histologic Proof of Medulloblastoma|This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
11204786|NCT02223650|OG000|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
11204787|NCT02223650|OG001|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
10820491|NCT00058422|BG000|Baseline|R-CHOP and Ibritumomab Tiuxetan (Zevalin)|"Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.~Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years."
10847541|NCT00283712|OG000|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
11204788|NCT02223650|OG000|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
11204789|NCT02223650|OG001|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
11204790|NCT02223650|EG000|Reported Event|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
11204791|NCT02223650|EG001|Reported Event|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
11204792|NCT02223689|BG000|Baseline|Skin Affix|"Surgical adhesive~Skin Affix"
11204793|NCT02223689|FG000|Participant Flow|Skin Affix|Surgical adhesive (Skin Affix) applied during wound closure in ED
10804667|NCT02763579|BG000|Baseline|Atezolizumab + Carboplatin + Etoposide|Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804668|NCT02763579|BG001|Baseline|Placebo + Carboplatin + Etoposide|Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804669|NCT02763579|BG002|Baseline|Total|Total of all reporting groups
10804670|NCT02763579|FG000|Participant Flow|Atezolizumab + Carboplatin + Etoposide|Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804671|NCT02763579|FG001|Participant Flow|Placebo + Carboplatin + Etoposide|Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804672|NCT02763579|OG000|Outcome|Atezolizumab + Carboplatin + Etoposide|Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
11204794|NCT02223689|OG000|Outcome|Skin Affix|Surgical adhesive
11204795|NCT02223689|OG000|Outcome|Change in Pain Following Application|Pain assessed through a pain score 0-5. 0 = no pain, 5 = highest pain.
11204796|NCT02223689|EG000|Reported Event|Skin Affix|"Surgical adhesive~Skin Affix"
11204797|NCT02223702|BG000|Baseline|Amoxicillin+Metronidazole|"amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.~Amoxicillin: 500 mg, 3 times per day for 7 days~Metronidazole: 500 mg, 3 times per day, for 7 days"
11204798|NCT02223702|BG001|Baseline|Moxifloxacin|"The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.~Moxifloxacin: 400 mg, once in a day for 7 days."
11204799|NCT02223702|BG002|Baseline|Total|Total of all reporting groups
11204800|NCT02223702|FG000|Participant Flow|Amoxicillin+Metronidazole|"amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.~Amoxicillin: 500 mg, 3 times per day for 7 days~Metronidazole: 500 mg, 3 times per day, for 7 days"
11204801|NCT02223702|FG001|Participant Flow|Moxifloxacin|"The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.~Moxifloxacin: 400 mg, once in a day for 7 days."
11204802|NCT02223702|OG000|Outcome|Amoxicillin+Metronidazole|"amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.~Amoxicillin: 500 mg, 3 times per day for 7 days~Metronidazole: 500 mg, 3 times per day, for 7 days"
11204803|NCT02223702|OG001|Outcome|Moxifloxacin|"The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.~Moxifloxacin: 400 mg, once in a day for 7 days."
11204804|NCT02223702|EG000|Reported Event|Amoxicillin+Metronidazole|"amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.~Amoxicillin: 500 mg, 3 times per day for 7 days~Metronidazole: 500 mg, 3 times per day, for 7 days"
11204805|NCT02223702|EG001|Reported Event|Moxifloxacin|"The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.~Moxifloxacin: 400 mg, once in a day for 7 days."
11204806|NCT02223715|BG000|Baseline|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
11204807|NCT02223715|FG000|Participant Flow|Clostridium Difficile Infection|To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
11204808|NCT02223715|OG000|Outcome|Medical History|To characterize the management and outcome of Clostridium Difficile Infection
11204809|NCT02223715|OG000|Outcome|Status at the End of CDI Episode|To characterize the management and outcome of Clostridium Difficile Infection
11204810|NCT02223715|OG000|Outcome|Clinical Complication|
11204811|NCT02223715|OG000|Outcome|Recurrence or Not After 2 Months Follow-up|
11204812|NCT02223715|EG000|Reported Event|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
11204813|NCT02223754|BG000|Baseline|Etafilcon A / Lotrafilcon B|Subjects that were randomized to this sequence and were dispensed a study lens.
10804673|NCT02763579|OG001|Outcome|Placebo + Carboplatin + Etoposide|Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804674|NCT02763579|EG000|Reported Event|Atezolizumab + Carboplatin + Etoposide|Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804675|NCT02763579|EG001|Reported Event|Placebo + Carboplatin + Etoposide|Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
10804676|NCT02762708|BG000|Baseline|Roux-en-Y Gastric Bypass (RYGB)|"Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.~Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery."
10804677|NCT02762708|BG001|Baseline|Caloric Restriction|"Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.~Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician."
10804678|NCT02762708|BG002|Baseline|Exendin-9,39|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804679|NCT02762708|BG003|Baseline|Normal Saline|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804680|NCT02762708|BG004|Baseline|Total|Total of all reporting groups
10804681|NCT02762708|FG000|Participant Flow|Roux-en-Y Gastric Bypass (RYGB)|"Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.~Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery."
10804682|NCT02762708|FG001|Participant Flow|Caloric Restriction|"Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.~Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician."
10804683|NCT02762708|FG002|Participant Flow|Exendin-9,39|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804684|NCT02762708|FG003|Participant Flow|Normal Saline|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
11204814|NCT02223754|BG001|Baseline|Lotrafilcon B / Etafilcon A|Subjects that were randomized to this sequence and were dispensed a study lens.
11204815|NCT02223754|BG002|Baseline|Total|Total of all reporting groups
11204816|NCT02223754|FG000|Participant Flow|Etafilcon A / Lotrafilcon B|Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
10804685|NCT02762708|OG000|Outcome|Roux-en-Y Gastric Bypass (RYGB)|"Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.~Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery."
10804686|NCT02762708|OG001|Outcome|Caloric Restriction|"Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.~Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician."
10804687|NCT02762708|OG000|Outcome|Exendin-9,39|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804688|NCT02762708|OG001|Outcome|Normal Saline|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804689|NCT02762708|EG000|Reported Event|Roux-en-Y Gastric Bypass (RYGB)|"Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.~Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery."
10804690|NCT02762708|EG001|Reported Event|Caloric Restriction|"Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.~Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician."
10804691|NCT02762708|EG002|Reported Event|Exendin-9,39|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804692|NCT02762708|EG003|Reported Event|Normal Saline|"Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.~Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
10804693|NCT02743494|BG000|Baseline|Nivolumab|Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles
10804694|NCT02743494|BG001|Baseline|Placebo|Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
10804695|NCT02743494|BG002|Baseline|Total|Total of all reporting groups
10804696|NCT02743494|FG000|Participant Flow|Nivolumab|Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles
10804697|NCT02743494|FG001|Participant Flow|Placebo|Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
10804698|NCT02743494|OG000|Outcome|Nivolumab|Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles
10804699|NCT02743494|OG001|Outcome|Placebo|Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
10804700|NCT02743494|EG000|Reported Event|Nivolumab|Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles
10804701|NCT02743494|EG001|Reported Event|Placebo|Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
10804702|NCT02741570|BG000|Baseline|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
10804703|NCT02741570|BG001|Baseline|EXTREME Regimen|Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
11286157|NCT02884427|EG002|Reported Event|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.~Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
10804704|NCT02741570|BG002|Baseline|Total|Total of all reporting groups
10804705|NCT02741570|FG000|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
11204817|NCT02223754|FG001|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
11204818|NCT02223754|OG000|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
11204819|NCT02223754|OG001|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
11204820|NCT02223754|OG001|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
11204821|NCT02223754|EG000|Reported Event|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
11204822|NCT02223754|EG001|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
11204823|NCT02223793|BG000|Baseline|No Information on High Risk Factor Levels But Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks~No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks"
11204824|NCT02223793|BG001|Baseline|No Information on High Risk Factor Levels Nor Lifestyle Advice|"In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline~No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels."
11204825|NCT02223793|BG002|Baseline|Information on High Risk Factor Levels and Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks~Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks"
11204826|NCT02223793|BG003|Baseline|Total|Total of all reporting groups
11204827|NCT02223793|FG000|Participant Flow|No Information on High Risk Factor Levels But Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks~No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks"
11204828|NCT02223793|FG001|Participant Flow|No Information on High Risk Factor Levels Nor Lifestyle Advice|"In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline~No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels."
11204829|NCT02223793|FG002|Participant Flow|Information on High Risk Factor Levels and Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks~Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks"
11204830|NCT02223793|OG000|Outcome|No Information on High Risk Factor Levels But Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks~No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks"
11204831|NCT02223793|OG001|Outcome|No Information on High Risk Factor Levels Nor Lifestyle Advice|"In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline~No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels."
11204832|NCT02223793|OG002|Outcome|Information on High Risk Factor Levels and Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks~Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks"
11204833|NCT02223793|EG000|Reported Event|No Information on High Risk Factor Levels But Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks~No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks"
11204834|NCT02223793|EG001|Reported Event|No Information on High Risk Factor Levels Nor Lifestyle Advice|"In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline~No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels."
10804706|NCT02741570|FG001|Participant Flow|EXTREME Regimen|Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
10804707|NCT02741570|OG000|Outcome|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
10804708|NCT02741570|OG001|Outcome|EXTREME Regimen|Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
10804709|NCT02741570|EG000|Reported Event|Nivolumab + Ipilimumab|Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
10804710|NCT02741570|EG001|Reported Event|EXTREME Regimen|Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
10804711|NCT02720952|BG000|Baseline|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day's dose.~Infacort®: dry granule formulation of hydrocortisone"
10804712|NCT02720952|FG000|Participant Flow|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day's dose.~Infacort®: dry granule formulation of hydrocortisone"
10804713|NCT02720952|OG000|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day's dose.~Infacort®: dry granule formulation of hydrocortisone"
10804714|NCT02720952|OG000|Outcome|Question 1|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child found swallowing easy.
10804715|NCT02720952|OG001|Outcome|Question 2|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child showed a positive reaction after Infacort was given.
10804716|NCT02720952|OG002|Outcome|Question 3|Percentage of parents/carers that agreed, or strongly agreed with the statement: I would be happy to give my child Infacort in the future.
10804717|NCT02720952|OG003|Outcome|Question 4|Percentage of parents/carers that agreed, or strongly agreed with the statement: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.
10804718|NCT02720952|EG000|Reported Event|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day's dose.~Infacort®: dry granule formulation of hydrocortisone"
10804719|NCT02667587|BG000|Baseline|Radiotherapy, Temozolomide Plus Nivolumab|Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
10804720|NCT02667587|BG001|Baseline|Radiotherapy, Temozolomide Plus Placebo|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
10804721|NCT02667587|BG002|Baseline|Total|Total of all reporting groups
10804722|NCT02667587|FG000|Participant Flow|Radiotherapy, Temozolomide Plus Nivolumab|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
10804723|NCT02667587|FG001|Participant Flow|Radiotherapy, Temozolomide Plus Placebo|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
11244122|NCT02509026|FG000|Participant Flow|Etanercept|All enrolled participants with non-radiographic axial spondyloarthritis (nr-ax SpA) were treated for 24 weeks with 50-milligram (mg) weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ankylosing spondylitis disease activity scale (ASDAS) C-reactive protein (CRP) level less than (<) 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS erythrocyte sedimentation rate (ESR) level greater than or equal to (>=) 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
11244123|NCT02509026|OG000|Outcome|Etanercept|All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level < 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level >= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
11244124|NCT02509026|OG000|Outcome|Etanercept: Period 1|All enrolled participants with nr-ax SpA were treated for 24 weeks with 50 milligram weekly dose of Etanercept in Period 1 (Induction Period). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
11244125|NCT02509026|OG001|Outcome|Etanercept: Period 2|Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
11244126|NCT02509026|OG002|Outcome|Etanercept: Period 3|Participants who achieved an ASDAS ESR level >= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
11244127|NCT02509026|EG000|Reported Event|Etanercept: Period 1|All enrolled participants with nr-ax SpA were treated for 24 weeks with 50 milligram weekly dose of Etanercept in Period 1 (Induction Period). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
11244128|NCT02509026|EG001|Reported Event|Etanercept: Period 2|Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
11244129|NCT02509026|EG002|Reported Event|Etanercept: Period 3|Participants who achieved an ASDAS ESR level >= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
11244130|NCT02509065|BG000|Baseline|All Enrolled Subjects|All subjects enrolled into the study
11244131|NCT02509065|FG000|Participant Flow|110B, 110IO|Arms were completed in the following order: 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
11244132|NCT02509065|FG001|Participant Flow|110B, 110IO, 120IO|"Arms were completed in the following order:~110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244133|NCT02509065|FG002|Participant Flow|110IO, 110B, 120IO|Arms were completed in the following order: 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 120 mg/dl insulin only bionic pancreas
11244134|NCT02509065|FG003|Participant Flow|UC, 115B, 100B, 145IO, 130B, 130IO|Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas
10804724|NCT02667587|OG000|Outcome|Radiotherapy, Temozolomide Plus Nivolumab|Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
11244135|NCT02509065|FG004|Participant Flow|145IO, 100B, 130B, 130IO, UC, 115|Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas
11244136|NCT02509065|FG005|Participant Flow|UC, 115B, 145IO, 100B, 130IO, 130B|Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas
11244137|NCT02509065|FG006|Participant Flow|130B, 130IO, 115B, UC, 100B, 145IO, 120IO|Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, usual care, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 120 mg/dl insulin only bionic pancreas
11244138|NCT02509065|FG007|Participant Flow|145IO, 100B, UC, 115B, 130IO, 130B, 110B, 110IO|Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
11244139|NCT02509065|FG008|Participant Flow|UC, 115B, 100B, 145IO, 130IO, 130B, 110IO, 110B|Arms were completed int he following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
11244140|NCT02509065|FG009|Participant Flow|130IO, 130B, UC, 145IO, 115B, 100B, 110B, 110IO|Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
10804725|NCT02667587|OG001|Outcome|Radiotherapy, Temozolomide Plus Placebo|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
10804726|NCT02667587|EG000|Reported Event|Radiotherapy, Temozolomide Plus Nivolumab|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
10804727|NCT02667587|EG001|Reported Event|Radiotherapy, Temozolomide Plus Placebo|"Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions).~Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses~Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles."
10804728|NCT02621606|BG000|Baseline|Part 1, Healthy Participants|Healthy participants receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 1 of the study.
10804729|NCT02621606|BG001|Baseline|Part 2, Healthy Elderly Participants|Healthy elderly participants receive two separate IV doses of ~370 MBq [11C]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
10804730|NCT02621606|BG002|Baseline|Part 3, Participants With AD|Participants with AD receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 3 of the study.
10804731|NCT02621606|BG003|Baseline|Total|Total of all reporting groups
10804732|NCT02621606|FG000|Participant Flow|Part 1, Healthy Participants|Healthy participants receive a single intravenous (IV) dose of ~370 megabecquerel (MBq) [11C]MK-6884 in Part 1 of the study.
10804733|NCT02621606|FG001|Participant Flow|Part 2, Healthy Elderly Participants|Healthy elderly participants receive two separate IV doses of ~370 MBq [11C]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
10804734|NCT02621606|FG002|Participant Flow|Part 3, Participants With AD|Participants with AD receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 3 of the study.
10804735|NCT02621606|OG000|Outcome|Part 1, Healthy Participants|Healthy participants receive a single IV dose of ~370 megabecquerel MBq [11C]MK-6884 in Part 1 of the study.
10804736|NCT02621606|OG001|Outcome|Part 2, Healthy Elderly Participants|Healthy elderly participants receive two separate IV doses of ~370 MBq [11C]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
10804737|NCT02621606|OG002|Outcome|Part 3, Participants With AD|Participants with AD receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 3 of the study.
10804738|NCT02621606|EG000|Reported Event|Part 1, Healthy Participants|Healthy participants receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 1 of the study.
10804739|NCT02621606|EG001|Reported Event|Part 2, Healthy Elderly Participants|Healthy elderly participants receive two separate IV doses of ~370 MBq [11C]MK-6884 in Part 2 of the study. Administration of the two doses is separated by at least 3 hours.
11204835|NCT02223793|EG002|Reported Event|Information on High Risk Factor Levels and Lifestyle Advice|"This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks~Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks"
10804740|NCT02621606|EG002|Reported Event|Part 3, Participants With AD|Participants with AD receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 3 of the study.
10804741|NCT02613507|BG000|Baseline|Nivolumab|3 mg/kg every 2 weeks until disease progression or unacceptable toxicity
10804742|NCT02613507|BG001|Baseline|Docetaxel|75 mg/m² every 3 weeks until disease progression or unacceptable toxicity
10804743|NCT02613507|BG002|Baseline|Total|Total of all reporting groups
10804744|NCT02613507|FG000|Participant Flow|Nivolumab|3 mg/kg every 2 weeks until disease progression or unacceptable toxicity
10804745|NCT02613507|FG001|Participant Flow|Docetaxel|75 mg/m² every 3 weeks until disease progression or unacceptable toxicity
10804746|NCT02613507|OG000|Outcome|Nivolumab|3 mg/kg every 2 weeks until disease progression or unacceptable toxicity
10804747|NCT02613507|OG001|Outcome|Docetaxel|75 mg/m² every 3 weeks until disease progression or unacceptable toxicity
10804748|NCT02613507|EG000|Reported Event|Nivolumab|3 mg/kg every 2 weeks until disease progression or unacceptable toxicity
10804749|NCT02613507|EG001|Reported Event|Docetaxel|75 mg/m² every 3 weeks until disease progression or unacceptable toxicity
10967030|NCT00891046|BG004|Baseline|ACZ885 Treatment Naive|Participants who were canakinumab treatment- naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11204836|NCT02223858|BG000|Baseline|Positive Activities (PA)|Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
11204837|NCT02223858|BG001|Baseline|Attention Control (AC)|Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
11204838|NCT02223858|BG002|Baseline|Total|Total of all reporting groups
11204839|NCT02223858|FG000|Participant Flow|Positive Activities (PA)|Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
11204840|NCT02223858|FG001|Participant Flow|Attention Control (AC)|Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
11204841|NCT02223858|OG000|Outcome|Positive Activities (PA)|Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
11204842|NCT02223858|OG001|Outcome|Attention Control (AC)|Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
11204843|NCT02223858|EG000|Reported Event|Positive Activities (PA)|Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
11244141|NCT02509065|FG010|Participant Flow|130B, 130IO, UC, 145IO, 115B, 100B, 110B, 110IO|Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas,130 mg/dl insulin only bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
11244142|NCT02509065|FG011|Participant Flow|100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B|Arms were completed in the following order: 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
11244143|NCT02509065|FG012|Participant Flow|130IO, 130B, 145IO, 100B, 115B, UC, 110B, 110IO, 120IO|"Arms were completed in the following order:~130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244144|NCT02509065|FG013|Participant Flow|115B, UC, 130B, 130IO, 145IO, 100B, 110IO, 110B, 120IO|"Arms were completed in the following order:~115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
10967031|NCT00891046|BG005|Baseline|Total|Total of all reporting groups
10967032|NCT00891046|FG000|Participant Flow|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from Study CACZ885G2301 Part 2 (NCT00889863) due to SJIA flare, received a subcutaneous (s.c.).
10804754|NCT02557945|BG000|Baseline|Gabapentin|"Gabapentin 3600mg PO daily~Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804755|NCT02557945|BG001|Baseline|Placebo|"Matching placebo PO daily~Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804756|NCT02557945|BG002|Baseline|Total|Total of all reporting groups
10804757|NCT02557945|FG000|Participant Flow|Gabapentin|"Gabapentin 3600mg PO daily~Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804758|NCT02557945|FG001|Participant Flow|Placebo|"Matching placebo PO daily~Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804759|NCT02557945|OG000|Outcome|Gabapentin|"Gabapentin 3600mg PO daily~Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804760|NCT02557945|OG001|Outcome|Placebo|"Matching placebo PO daily~Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804761|NCT02557945|EG000|Reported Event|Gabapentin|"Gabapentin 3600mg PO daily~Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804762|NCT02557945|EG001|Reported Event|Placebo|"Matching placebo PO daily~Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)"
10804763|NCT02553915|BG000|Baseline|Placebo|"Soybean oil placebo capsules, 4 capsules daily for 12 weeks~Placebo: Soybean oil placebo"
10804764|NCT02553915|BG001|Baseline|EPA 1 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day"
10804765|NCT02553915|BG002|Baseline|EPA 2 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day"
10804766|NCT02553915|BG003|Baseline|EPA 4 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks~EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day"
10804767|NCT02553915|BG004|Baseline|Total|Total of all reporting groups
10804768|NCT02553915|FG000|Participant Flow|Placebo|"Soybean oil placebo capsules, 4 capsules daily for 12 weeks~Placebo: Soybean oil placebo"
10804769|NCT02553915|FG001|Participant Flow|EPA 1 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day"
10804770|NCT02553915|FG002|Participant Flow|EPA 2 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day"
10804771|NCT02553915|FG003|Participant Flow|EPA 4 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks~EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day"
10804772|NCT02553915|OG000|Outcome|Placebo|"Soybean oil placebo capsules, 4 capsules daily for 12 weeks~Placebo: Soybean oil placebo"
10804773|NCT02553915|OG001|Outcome|EPA 1 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day"
10804774|NCT02553915|OG002|Outcome|EPA 2 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day"
10804775|NCT02553915|OG003|Outcome|EPA 4 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks~EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day"
10804776|NCT02553915|EG000|Reported Event|Placebo|"Soybean oil placebo capsules, 4 capsules daily for 12 weeks~Placebo: Soybean oil placebo"
10804777|NCT02553915|EG001|Reported Event|EPA 1 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day"
10804778|NCT02553915|EG002|Reported Event|EPA 2 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks~Placebo: Soybean oil placebo~EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day"
10804779|NCT02553915|EG003|Reported Event|EPA 4 g/Day|"Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks~EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day"
10804780|NCT02550873|BG000|Baseline|PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804781|NCT02550873|BG001|Baseline|Placebo|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804782|NCT02550873|BG002|Baseline|Total|Total of all reporting groups
10804783|NCT02550873|FG000|Participant Flow|PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804784|NCT02550873|FG001|Participant Flow|Placebo|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804785|NCT02550873|FG002|Participant Flow|Open Label PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804786|NCT02550873|OG000|Outcome|PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804787|NCT02550873|OG001|Outcome|Placebo|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804788|NCT02550873|OG000|Outcome|PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804789|NCT02550873|OG000|Outcome|PRM-151 10 mg/kg; No Background Therapy|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib"
10804790|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg; Pirfenidone or Nintedanib|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib"
10804791|NCT02550873|OG002|Outcome|Placebo; No Background Therapy|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib"
10804792|NCT02550873|OG003|Outcome|Placebo; Pirfenidone or Nintedanib|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib"
10804793|NCT02550873|OG000|Outcome|PRM-151 10 mg/kg, no Background Therapy|"Dosing Every 4 Weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804794|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804795|NCT02550873|OG002|Outcome|Placebo, no Background Therapy|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804796|NCT02550873|OG003|Outcome|Placebo; Pirfenidone or Nintedanib|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804797|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg; Pirfenidone or Nintedanib|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib therapy"
10804798|NCT02550873|OG003|Outcome|Placebo; Pirfenidone or Nintedanib|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib"
10804799|NCT02550873|OG000|Outcome|PRM-151 10 mg/kg, no Background Therapy|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804800|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg; Pirfenidone or Nintedanib|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804801|NCT02550873|OG003|Outcome|Placebo; Pirfenidone or Nintedanib|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804802|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib|"Dosing Every 4 Weeks~PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804803|NCT02550873|OG001|Outcome|PRM-151 10 mg/kg; Pirfenidone or Nintedanib|"Dosing Every 4 weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804804|NCT02550873|EG000|Reported Event|PRM-151 10 mg/kg|"Dosing Every 4 Weeks~PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks"
10804805|NCT02550873|EG001|Reported Event|Placebo|"Dosing Every 4 weeks~placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks"
10804806|NCT02542267|BG000|Baseline|Gore VIABAHN Endoprosthesis|"Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery~Gore VIABAHN Endoprosthesis"
10804807|NCT02542267|FG000|Participant Flow|Gore VIABAHN Endoprosthesis|"Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery~Gore VIABAHN Endoprosthesis"
10804808|NCT02542267|OG000|Outcome|Gore VIABAHN Endoprosthesis|"Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery~Gore VIABAHN Endoprosthesis"
10804809|NCT02542267|EG000|Reported Event|Gore VIABAHN Endoprosthesis|"Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery~Gore VIABAHN Endoprosthesis"
10967033|NCT00891046|FG001|Participant Flow|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed Study CACZ885G2301 (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11244145|NCT02509065|FG014|Participant Flow|UC, 145IO, 130B, 130IO, 100B, 115B, 110IO, 110B, 120IO|"Arms were completed in the following order:~Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
10804850|NCT02483585|BG000|Baseline|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804851|NCT02483585|BG001|Baseline|Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804852|NCT02483585|BG002|Baseline|Total|Total of all reporting groups
10804853|NCT02483585|FG000|Participant Flow|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804854|NCT02483585|FG001|Participant Flow|Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804855|NCT02483585|OG000|Outcome|Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804856|NCT02483585|OG001|Outcome|Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
10804857|NCT02483585|OG000|Outcome|Double-blind Treatment Phase (12 Weeks): Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
11204844|NCT02223858|EG001|Reported Event|Attention Control (AC)|Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
10804858|NCT02483585|OG001|Outcome|Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
10804859|NCT02483585|OG002|Outcome|Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM|Participants received erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 during the open-label treatment phase.
10804860|NCT02483585|EG000|Reported Event|Double-blind Treatment Phase (12 Weeks): Placebo|Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
10804861|NCT02483585|EG001|Reported Event|Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM|Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection the double-blind treatment phase.
10804862|NCT02483585|EG002|Reported Event|Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM|Participants received erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 during the open-label treatment phase
10804863|NCT02462603|BG000|Baseline|PTC589|Participants with Parkinson's disease (idiopathic and mitochondrial genetic subtype participants) received PTC589 at a dose of 500 mg (2 tablets of 250 mg each) orally BID for up to 3 months unless discontinued for safety or tolerability issues.
10804864|NCT02462603|FG000|Participant Flow|PTC589|Participants with Parkinson's disease (idiopathic and mitochondrial genetic subtype participants) received PTC589 at a dose of 500 milligrams (mg) (2 tablets of 250 mg each) orally twice daily (BID) for up to 3 months unless discontinued for safety or tolerability issues.
10804865|NCT02462603|OG000|Outcome|PTC589|Participants with Parkinson's disease (idiopathic and mitochondrial genetic subtype participants) received PTC589 at a dose of 500 mg (2 tablets of 250 mg each) orally BID for up to 3 months unless discontinued for safety or tolerability issues.
10804866|NCT02462603|EG000|Reported Event|PTC589|Participants with Parkinson's disease (idiopathic and mitochondrial genetic subtype participants) received PTC589 at a dose of 500 mg (2 tablets of 250 mg each) orally BID for up to 3 months unless discontinued for safety or tolerability issues.
10804867|NCT02456740|BG000|Baseline|Placebo|Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804868|NCT02456740|BG001|Baseline|Erenumab 70 mg QM|Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804869|NCT02456740|BG002|Baseline|Erenumab 140 mg QM|Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804870|NCT02456740|BG003|Baseline|Total|Total of all reporting groups
10804871|NCT02456740|FG000|Participant Flow|Placebo|Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804872|NCT02456740|FG001|Participant Flow|Erenumab 70 mg QM|Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804873|NCT02456740|FG002|Participant Flow|Erenumab 140 mg QM|Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804874|NCT02456740|FG003|Participant Flow|Placebo / Erenumab 70 mg|Participants originally randomized to receive placebo in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 70 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804875|NCT02456740|FG004|Participant Flow|Erenumab 70 mg / Erenumab 70 mg|Participants originally randomized to receive erenumab 70 mg QM in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 70 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804876|NCT02456740|FG005|Participant Flow|Erenumab 140 mg / Erenumab 70 mg|Participants originally randomized to receive erenumab 140 mg QM in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 70 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804877|NCT02456740|FG006|Participant Flow|Placebo / Erenumab 140 mg|Participants originally randomized to receive placebo QM in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 140 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804878|NCT02456740|FG007|Participant Flow|Erenumab 70 mg / Erenumab 140 mg|Participants originally randomized to receive erenumab 70 mg QM in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 140 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804879|NCT02456740|FG008|Participant Flow|Erenumab 140 mg / Erenumab 140 mg|Participants originally randomized to receive erenumab 140 mg QM in the 24-week double-blind treatment phase were re-randomized at week 24 to receive erenumab 140 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804880|NCT02456740|OG000|Outcome|Placebo|Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804881|NCT02456740|OG001|Outcome|Erenumab 70 mg QM|Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804882|NCT02456740|OG002|Outcome|Erenumab 140 mg QM|Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804883|NCT02456740|EG000|Reported Event|Double-blind Treatment Phase: Placebo|Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804884|NCT02456740|EG001|Reported Event|Double-blind Treatment Phase: Erenumab 70 mg|Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804885|NCT02456740|EG002|Reported Event|Double-blind Treatment Phase: Erenumab 140 mg|Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase.
10804886|NCT02456740|EG003|Reported Event|Active Treatment Phase: Erenumab 70 mg|Participants received erenumab 70 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804887|NCT02456740|EG004|Reported Event|Active Treatment Phase: Erenumab 140 mg|Participants received erenumab 140 mg subcutaneously at weeks 24, 28, 32, 36, 40, 44, and 48 in the active treatment phase.
10804888|NCT02438410|BG000|Baseline|Hospitalized Patients Receiving Infliximab|Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
10804889|NCT02438410|FG000|Participant Flow|Hospitalized Patients Receiving Infliximab|Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
10804890|NCT02438410|OG000|Outcome|Hospitalized Patients Receiving Infliximab|Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
10804891|NCT02438410|EG000|Reported Event|Hospitalized Patients Receiving Infliximab|Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
10804902|NCT02420717|BG000|Baseline|Phase I Ruxolitinib 15mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804903|NCT02420717|BG001|Baseline|Phase I Ruxolitinib 20mg|Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804904|NCT02420717|BG002|Baseline|Phase I Ruxolitinib 25mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804905|NCT02420717|BG003|Baseline|Total|Total of all reporting groups
10804906|NCT02420717|FG000|Participant Flow|Phase I Ruxolitinib 15mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804907|NCT02420717|FG001|Participant Flow|Phase I Ruxolitinib 20mg|Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804908|NCT02420717|FG002|Participant Flow|Phase I Ruxolitinib 25mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804909|NCT02420717|OG000|Outcome|Phase I Ruxolitinib 15mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804910|NCT02420717|OG001|Outcome|Phase I Ruxolitinib 20mg|Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804911|NCT02420717|OG002|Outcome|Phase I Ruxolitinib 25mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804912|NCT02420717|EG000|Reported Event|Phase I Ruxolitinib 15mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11204845|NCT02223871|BG000|Baseline|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes occurred 16 days after ACT-451840 administration (or earlier if required).
11204846|NCT02223871|FG000|Participant Flow|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
11204847|NCT02223871|OG000|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
10804913|NCT02420717|EG001|Reported Event|Phase I Ruxolitinib 20mg|Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804914|NCT02420717|EG002|Reported Event|Phase I Ruxolitinib 25mg|Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10804915|NCT02408068|BG000|Baseline|All Study Participants|All patients received all 3 study treatments in randomised order
10804916|NCT02408068|FG000|Participant Flow|Sequence 1|Chronocort 20mg (fed), Chronocort 20mg (fasted), Hydrocortisone 20mg (fasted)
10804917|NCT02408068|FG001|Participant Flow|Sequence 2|Chronocort 20mg (fed), Hydrocortisone 20mg (fasted), Chronocort 20mg (fasted)
10804918|NCT02408068|FG002|Participant Flow|Sequence 3|Chronocort 20mg (fasted), Chronocort 20mg (fed), Hydrocortisone 20mg (fasted)
10804919|NCT02408068|FG003|Participant Flow|Sequence 4|Chronocort 20mg (fasted), Hydrocortisone 20mg (fasted), Chronocort 20mg (fed)
10804920|NCT02408068|FG004|Participant Flow|Sequence 5|Hydrocortisone 20mg (fasted), Chronocort 20mg (fed), Chronocort 20mg (fasted)
10804921|NCT02408068|FG005|Participant Flow|Sequence 6|Hydrocortisone 20mg (fasted), Chronocort 20mg (fasted), Chronocort 20mg (fed)
10804922|NCT02408068|OG000|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
10804923|NCT02408068|OG001|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
11204848|NCT02223871|EG000|Reported Event|ACT-451840 500 mg|The eight subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes on Day 0 and received 500 mg of ACT-451840 on Day 7. All of them received six doses of Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, as per protocol.
11204849|NCT02224053|BG000|Baseline|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
10804924|NCT02408068|OG002|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
10804925|NCT02408068|OG000|Outcome|Chronocort Fasted|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
10804926|NCT02408068|OG001|Outcome|Immediate-Release Hydrocortisone|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs, fast overnight, and take 20mg of randomised treatment with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
10804927|NCT02408068|OG002|Outcome|Chronocort Fed|Volunteers will be admitted, take dexamethasone to suppress endogenous cortisone at 22.00hrs and subsequently fast overnight. On the morning of Day 1, volunteers will eat a high fat breakfast and take 20mg of randomised treatment with 200 millilitres of water. Water will be allowed 1hr after the study drug is administered. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
10804928|NCT02408068|EG000|Reported Event|Chronocort : Fed|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and receive a high fat, high calorie breakfast on the morning of Day 1. Thirty minutes after the start of the breakfast they will receive 20mg of modified release hydrocortisone with 200 millilitres of water, and no further food for 4 hours, water will be allowed from 1 hour after the food. One baseline pharmacokinetics (PK) sample will be taken starting prior to the dose and then over 24 hours (29 samples).~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Chronocort: fed: single dose of 20mg modified release hydrocortisone in the presence of food"
10804929|NCT02408068|EG001|Reported Event|Chronocort: Fasted|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg modified release hydrocortisone with 200millilitres of water on the morning of Day 1. Water will be allowed 1hr after the dose, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Chronocort: fasted: single dose of 20mg modified release hydrocortisone in the absence of food"
10804930|NCT02408068|EG002|Reported Event|Immediate Release Hydrocortisone: Fasted|"Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg immediate release hydrocortisone with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)~Dexamethasone: Dexamethasone used to suppress endogenous cortisol secretion~Immediate release hydrocortisone: fasted: single dose of 20mg immediate release hydrocortisone in the absence of food"
10804931|NCT02315703|BG000|Baseline|Group 1: Ad26/Ad26 + gp140 High Dose (HD)|Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804932|NCT02315703|BG001|Baseline|Group 2: Ad26/Ad26 + gp140 Low Dose (LD)|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804933|NCT02315703|BG002|Baseline|Group 3: Ad26/Ad26|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
10804934|NCT02315703|BG003|Baseline|Group 4: Ad26/MVA + gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804935|NCT02315703|BG004|Baseline|Group 5: Ad26/ MVA + gp140 LD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804936|NCT02315703|BG005|Baseline|Group 6: Ad26/MVA|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
10804937|NCT02315703|BG006|Baseline|Group 7: Ad26/ gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804938|NCT02315703|BG007|Baseline|Group 8: Placebo/ Placebo|Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
10804939|NCT02315703|BG008|Baseline|Total|Total of all reporting groups
10967034|NCT00891046|FG002|Participant Flow|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11204850|NCT02224053|FG000|Participant Flow|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
11204851|NCT02224053|OG000|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
11204852|NCT02224053|OG001|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
10804940|NCT02315703|FG000|Participant Flow|Group 1: Ad26/Ad26 + gp140 High Dose (HD)|Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804941|NCT02315703|FG001|Participant Flow|Group 2: Ad26/Ad26 + gp140 Low Dose (LD)|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804942|NCT02315703|FG002|Participant Flow|Group 3: Ad26/Ad26|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
10804943|NCT02315703|FG003|Participant Flow|Group 4: Ad26/MVA + gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804944|NCT02315703|FG004|Participant Flow|Group 5: Ad26/ MVA + gp140 LD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804945|NCT02315703|FG005|Participant Flow|Group 6: Ad26/MVA|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
10804946|NCT02315703|FG006|Participant Flow|Group 7: Ad26/ gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804947|NCT02315703|FG007|Participant Flow|Group 8: Placebo/ Placebo|Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
10804948|NCT02315703|OG000|Outcome|Group 1: Ad26/Ad26 + gp140 High Dose (HD)|Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804949|NCT02315703|OG001|Outcome|Group 2: Ad26/Ad26 + gp140 Low Dose (LD)|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804950|NCT02315703|OG002|Outcome|Group 3: Ad26/Ad26|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
10804951|NCT02315703|OG003|Outcome|Group 4: Ad26/MVA + gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804952|NCT02315703|OG004|Outcome|Group 5: Ad26/ MVA + gp140 LD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804953|NCT02315703|OG005|Outcome|Group 6: Ad26/MVA|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
10804954|NCT02315703|OG006|Outcome|Group 7: Ad26/ gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804955|NCT02315703|OG007|Outcome|Group 8: Placebo/ Placebo|Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
10804956|NCT02315703|EG000|Reported Event|Group 1: Ad26/Ad26 + gp140 High Dose (HD)|Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804957|NCT02315703|EG001|Reported Event|Group 2: Ad26/Ad26 + gp140 Low Dose (LD)|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804958|NCT02315703|EG002|Reported Event|Group 3: Ad26/Ad26|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
10804959|NCT02315703|EG003|Reported Event|Group 4: Ad26/MVA + gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804960|NCT02315703|EG004|Reported Event|Group 5: Ad26/ MVA + gp140 LD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
10804961|NCT02315703|EG005|Reported Event|Group 6: Ad26/MVA|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
10804962|NCT02315703|EG006|Reported Event|Group 7: Ad26/ gp140 HD|Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
10804963|NCT02315703|EG007|Reported Event|Group 8: Placebo/ Placebo|Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
10820492|NCT00058422|FG000|Participant Flow|R-CHOP and Ibritumomab Tiuxetan (Zevalin)|"Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.~Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years."
10820493|NCT00058422|OG000|Outcome|R-CHOP and Ibritumomab Tiuxetan (Zevalin)|"Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.~Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years."
10820494|NCT00058422|EG000|Reported Event|R-CHOP and Ibritumomab Tiuxetan (Zevalin)|"Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.~Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years."
10820495|NCT00058539|BG000|Baseline|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
10820496|NCT00058539|FG000|Participant Flow|Pertuzumab|All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
10820497|NCT00058539|OG000|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
10820498|NCT00058539|EG000|Reported Event|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
10820499|NCT00058552|BG000|Baseline|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
10820500|NCT00058552|BG001|Baseline|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
10820501|NCT00058552|BG002|Baseline|Total|Total of all reporting groups
10820502|NCT00058552|FG000|Participant Flow|Pertuzumab 420 mg|Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
10820503|NCT00058552|FG001|Participant Flow|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
10820504|NCT00058552|OG000|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
10820505|NCT00058552|OG001|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
10804973|NCT02174861|BG000|Baseline|Erenumab|"Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.~Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study."
10804974|NCT02174861|FG000|Participant Flow|Erenumab|"Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.~Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study."
10804975|NCT02174861|OG000|Outcome|Erenumab|"Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.~Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study."
10804976|NCT02174861|OG000|Outcome|Erenumab 140 mg PFS|Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a prefilled syringe (PFS).
10804977|NCT02174861|OG001|Outcome|Erenumab 140 mg AI/Pen|Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
10804978|NCT02174861|EG000|Reported Event|Erenumab|"Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.~Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study."
10804979|NCT02052739|BG000|Baseline|SAGE-547 Standard Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
10804980|NCT02052739|BG001|Baseline|SAGE-547 High Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
10804981|NCT02052739|BG002|Baseline|Total|Total of all reporting groups
10804982|NCT02052739|FG000|Participant Flow|SAGE-547 Standard Dose|Participants received SAGE-547 intravenous (IV) loading infusion of 286.6 micrograms per kilogram per hour (μg/kg/hr) for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
10804983|NCT02052739|FG001|Participant Flow|SAGE-547 High Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
10804984|NCT02052739|OG000|Outcome|SAGE-547 Standard Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
10804985|NCT02052739|OG001|Outcome|SAGE-547 High Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
10804986|NCT02052739|OG000|Outcome|SAGE-547 Standard Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for 95 hours from Days 1 to 4 followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
10804987|NCT02052739|OG001|Outcome|SAGE-547 High Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
10804988|NCT02052739|EG000|Reported Event|SAGE-547 Standard Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for 95 hours from Days 1 to 4 followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
10804989|NCT02052739|EG001|Reported Event|SAGE-547 High Dose|Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
11204853|NCT02224053|EG000|Reported Event|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
10804999|NCT01944020|BG000|Baseline|Intervention - CPAP Use|"Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months~CPAP: use of CPAP each night for 2 months"
10805000|NCT01944020|BG001|Baseline|Control - No CPAP Use|Control will be no use of CPAP for 2 months
10805001|NCT01944020|BG002|Baseline|Total|Total of all reporting groups
10805002|NCT01944020|FG000|Participant Flow|Intervention - CPAP Use|"Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months~CPAP: use of CPAP each night for 2 months"
10805003|NCT01944020|FG001|Participant Flow|Control - No CPAP Use|Control will be no use of CPAP for 2 months
10805004|NCT01944020|OG000|Outcome|Intervention - CPAP Use|"Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months~CPAP: use of CPAP each night for 2 months"
10805005|NCT01944020|OG001|Outcome|Control - No CPAP Use|Control will be no use of CPAP for 2 months
10805006|NCT01944020|EG000|Reported Event|Intervention - CPAP Use|"Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months~CPAP: use of CPAP each night for 2 months"
10805007|NCT01944020|EG001|Reported Event|Control - No CPAP Use|Control will be no use of CPAP for 2 months
11204854|NCT02224053|EG001|Reported Event|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
11204855|NCT02224157|BG000|Baseline|Placebo Bid + Symbicort 'as Needed' (Experimental)|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
10805020|NCT01689519|BG000|Baseline|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805021|NCT01689519|BG001|Baseline|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805022|NCT01689519|BG002|Baseline|Total|Total of all reporting groups
10805023|NCT01689519|FG000|Participant Flow|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805024|NCT01689519|FG001|Participant Flow|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805025|NCT01689519|OG000|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805026|NCT01689519|OG001|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805027|NCT01689519|EG000|Reported Event|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805028|NCT01689519|EG001|Reported Event|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
10805029|NCT01622088|BG000|Baseline|Dexpramipexole 150 mg BID|Dexpramipexole: Oral tablet 150 mg given twice daily up to 36 months
10805030|NCT01622088|FG000|Participant Flow|Dexpramipexole 300 mg/Day|Dexpramipexole: Oral tablet 150 mg given twice daily up to 36 months
10805031|NCT01622088|OG000|Outcome|Dexpramipexole 150 mg BID|Dexpramipexole: Oral tablet 150 mg given twice daily up to 36 months
10805032|NCT01622088|OG000|Outcome|Dexpramipexole 150 mg BID|Dexpramipexole: Oral tablet 150 mg given twice daily up to 7 months
10805033|NCT01622088|EG000|Reported Event|Dexpramipexole 300 mg/Day|Dexpramipexole: Oral tablet 150 mg given twice daily up to 36 months
10805034|NCT01486264|BG000|Baseline|Xeomin Short Flex|Participants received Xeomin Short Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 6 to 10 weeks interval for up to 762 days.
10805035|NCT01486264|BG001|Baseline|Xeomin Long Flex|Participants received Xeomin Long Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 90 days to 16 weeks interval for up to 875 days.
10805036|NCT01486264|BG002|Baseline|Total|Total of all reporting groups
10805037|NCT01486264|FG000|Participant Flow|Xeomin Short Flex|Participants received Xeomin Short Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 6 to 10 weeks interval for up to 762 days.
10805038|NCT01486264|FG001|Participant Flow|Xeomin Long Flex|Participants received Xeomin Long Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 90 days to 16 weeks interval for up to 875 days.
10805039|NCT01486264|OG000|Outcome|Xeomin Short Flex|Participants received Xeomin Short Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 6 to 10 weeks interval for up to 762 days.
10805040|NCT01486264|OG001|Outcome|Xeomin Long Flex|Participants received Xeomin Long Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 90 days to 16 weeks interval for up to 875 days.
10805041|NCT01486264|EG000|Reported Event|Xeomin Short Flex|Participants received Xeomin Short Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 6 to 10 weeks interval for up to 762 days.
10805042|NCT01486264|EG001|Reported Event|Xeomin Long Flex|Participants received Xeomin Long Flex, intramuscular injection, once on Day 1 (Visit 1) followed by 8 subsequent injection visits at 90 days to 16 weeks interval for up to 875 days.
10805043|NCT01419080|BG000|Baseline|Peripheral Arterial Disease (PAD) Patients|Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
10805044|NCT01419080|FG000|Participant Flow|Peripheral Arterial Disease (PAD) Patients|Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
10805045|NCT01419080|OG000|Outcome|Received Invasive Treatment|Received invasive treatment (endovascular, surgical) as a primary treatment strategy (<=3 months following enrollment)
10805046|NCT01419080|OG001|Outcome|Did Not Receive Invasive Treatment|Did not receive invasive treatment (endovascular, surgical) as a primary treatment strategy (<=3 months following enrollment)
10805047|NCT01419080|OG000|Outcome|Peripheral Artery Disease (PAD) Patients|Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
10805048|NCT01419080|EG000|Reported Event|Peripheral Arterial Disease (PAD) Patients|Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
10805049|NCT01317160|BG000|Baseline|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
10805050|NCT01317160|BG001|Baseline|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
10805051|NCT01317160|BG002|Baseline|Total|Total of all reporting groups
10805052|NCT01317160|FG000|Participant Flow|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
10805053|NCT01317160|FG001|Participant Flow|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
10805054|NCT01317160|OG000|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
10805055|NCT01317160|OG001|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
10805056|NCT01317160|EG000|Reported Event|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
10805057|NCT01317160|EG001|Reported Event|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
10805058|NCT01234532|BG000|Baseline|Entinostat & Anastrozole Neoadjuvant|Neoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy.
10805059|NCT01234532|FG000|Participant Flow|Entinostat & Anastrozole Neoadjuvant|"Neoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy.~Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.~Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery.~entinostat: orally~anastrozole: Given PO~diagnostic laboratory biomarker analysis: Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.~Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery."
10820506|NCT00058552|OG000|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
10805060|NCT01234532|OG000|Outcome|Entinostat & Anastrozole Neoadjuvant|"Neoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy.~Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.~Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery.~entinostat: orally~anastrozole: Given PO~diagnostic laboratory biomarker analysis: Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.~Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery."
10805061|NCT01234532|EG000|Reported Event|Entinostat & Anastrozole Neoadjuvant|Neoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy.
10805073|NCT01154335|BG000|Baseline|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
10805074|NCT01154335|BG001|Baseline|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
10805075|NCT01154335|BG002|Baseline|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
10805076|NCT01154335|BG003|Baseline|Total|Total of all reporting groups
10805077|NCT01154335|FG000|Participant Flow|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
10805078|NCT01154335|FG001|Participant Flow|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
10805079|NCT01154335|FG002|Participant Flow|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
10805080|NCT01154335|OG000|Outcome|All Patients|Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
10805081|NCT01154335|OG000|Outcome|Dose Level 1|combination of OSI-906 (50 mg Twice a Day, cycle-28 days) and everolimus (5mg Daily, cycle-28 days)
10805082|NCT01154335|OG001|Outcome|Dose Level 2|combination of OSI-906 (100 mg Twice a Day, cycle-28 days) and everolimus (10 mg Daily, cycle-28 days)
10805083|NCT01154335|OG002|Outcome|Dose Level 2a|combination of OSI-906 (100 mg Twice a Day, cycle-28 days) and everolimus (5 mg Daily, cycle-28 days)
10805084|NCT01154335|OG000|Outcome|Dose Level 1|combination of OSI-906 (50 mg Twice a Day, cycle-28 days) and everolimus (5 mg Daily, cycle-28 days)
10805085|NCT01154335|EG000|Reported Event|Dose Level 1|combination of OSI-906 (50 mg Twice a Day, cycle-28 days) and everolimus (5 mg Daily, cycle-28 days)
10805086|NCT01154335|EG001|Reported Event|Dose Level 2|combination of OSI-906 (100 mg Twice a Day, cycle-28 days) and everolimus (10 mg Daily, cycle-28 days)
10805087|NCT01154335|EG002|Reported Event|Dose Level 2a|combination of OSI-906 (50 mg Twice a Day, cycle-28 days) and everolimus (5 mg Daily, cycle-28 days)
10805092|NCT01143116|BG000|Baseline|Catheter A|"Silver-nitrate coated catheter (Catheter A): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization."
10805093|NCT01143116|BG001|Baseline|Catheter B|"Degradable silver particle-coated catheter (Catheter B): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization."
10805094|NCT01143116|BG002|Baseline|Total|Total of all reporting groups
10805095|NCT01143116|FG000|Participant Flow|Catheter A|"Silver-nitrate coated catheter (Catheter A): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization."
10805096|NCT01143116|FG001|Participant Flow|Catheter B|"Degradable silver particle-coated catheter (Catheter B): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization."
10805097|NCT01143116|OG000|Outcome|Catheter A|"Silver-nitrate coated catheter (Catheter A): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization."
10805098|NCT01143116|OG001|Outcome|Catheter B|"Degradable silver particle-coated catheter (Catheter B): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization."
10805099|NCT01143116|EG000|Reported Event|Catheter A|"Silver-nitrate coated catheter (Catheter A): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization."
10805100|NCT01143116|EG001|Reported Event|Catheter B|"Degradable silver particle-coated catheter (Catheter B): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization."
11244146|NCT02509065|FG015|Participant Flow|UC, 145IO, 130B, 130IO, 100B, 115B, 110B, 110IO, 120IO|"Arms were completed in the following order:~Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11204856|NCT02224157|BG001|Baseline|Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator)|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4mg 'as needed'
11204857|NCT02224157|BG002|Baseline|Total|Total of all reporting groups
11204858|NCT02224157|FG000|Participant Flow|Placebo Bid + Symbicort 'as Needed' (Experimental)|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
11204859|NCT02224157|FG001|Participant Flow|Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator)|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4mg 'as needed'
10805155|NCT01094782|BG000|Baseline|Healthy - True Acupuncture|"Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805156|NCT01094782|BG001|Baseline|Healthy - Sham Acupuncture|"Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805157|NCT01094782|BG002|Baseline|Healthy - No Treatment|Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805158|NCT01094782|BG003|Baseline|Pain - True Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805159|NCT01094782|BG004|Baseline|Pain - Sham Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805160|NCT01094782|BG005|Baseline|Pain - No Treatment|Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805161|NCT01094782|BG006|Baseline|Total|Total of all reporting groups
10805162|NCT01094782|FG000|Participant Flow|Healthy - True Acupuncture|"Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805163|NCT01094782|FG001|Participant Flow|Healthy - Sham Acupuncture|"Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805164|NCT01094782|FG002|Participant Flow|Healthy - No Treatment|Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805165|NCT01094782|FG003|Participant Flow|Pain - True Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805166|NCT01094782|FG004|Participant Flow|Pain - Sham Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805167|NCT01094782|FG005|Participant Flow|Pain - No Treatment|Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805168|NCT01094782|OG000|Outcome|Healthy - True Acupuncture|"Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805169|NCT01094782|OG001|Outcome|Healthy - Sham Acupuncture|"Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805170|NCT01094782|OG002|Outcome|Healthy - No Treatment|Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805171|NCT01094782|OG003|Outcome|Pain - True Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805172|NCT01094782|OG004|Outcome|Pain - Sham Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805173|NCT01094782|OG005|Outcome|Pain - No Treatment|Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805174|NCT01094782|EG000|Reported Event|Healthy - True Acupuncture|"Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
11204860|NCT02224157|OG000|Outcome|Placebo Bid + Symbicort 'as Needed' (Experimental)|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
10805175|NCT01094782|EG001|Reported Event|Healthy - Sham Acupuncture|"Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805176|NCT01094782|EG002|Reported Event|Healthy - No Treatment|Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805177|NCT01094782|EG003|Reported Event|Pain - True Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received true acupuncture treatment (the needles punctured the skin)."
10805178|NCT01094782|EG004|Reported Event|Pain - Sham Acupuncture|"Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.~This group received sham acupuncture treatment (the needles did not puncture the skin)."
10805179|NCT01094782|EG005|Reported Event|Pain - No Treatment|Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
10805180|NCT01033032|BG000|Baseline|Phase I - Dose Level 1|Amrubicin -90 mg/m^2 by intravenous(IV) every 21days
10805181|NCT01033032|BG001|Baseline|Phase I - Dose Level 2|Amrubicin -100 mg/m^2 IV every 21days
10805182|NCT01033032|BG002|Baseline|Phase I - Dose Level 3|Amrubicin -110 mg/m^2 IV every 21days
10805183|NCT01033032|BG003|Baseline|Phase I - Dose Level 4|Amrubicin -120 mg/m^2 every 21 days
10805184|NCT01033032|BG004|Baseline|Phase II - Dose Level 3|Amrubicin -110 mg/m^2 IV every 21days
10805185|NCT01033032|BG005|Baseline|Total|Total of all reporting groups
10805186|NCT01033032|FG000|Participant Flow|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
10805187|NCT01033032|FG001|Participant Flow|Dose Level 2|Amrubicin - 100 mg/m^2 IV every 21 days
10805188|NCT01033032|FG002|Participant Flow|Dose Level 3|Amrubicin - 110 mg/m^2 IV every 21 days
10805189|NCT01033032|FG003|Participant Flow|Dose Level 4|Amrubicin - 120 mg/m^2 every 21 days
10805190|NCT01033032|FG004|Participant Flow|Phase II|Amrubicin - 110 mg/m^2 IV every 21 days
10805191|NCT01033032|OG000|Outcome|Amrubicin|Systemic therapy with amrubicin
10805192|NCT01033032|OG000|Outcome|Dose Level 1|Amrubicin -90 mg/m^2 by intravenous(IV) every 21days
11204861|NCT02224157|OG001|Outcome|Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator)|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4mg 'as needed'
10805193|NCT01033032|OG001|Outcome|Dose Level 2|Amrubicin -100 mg/m^2 IV every 21days
10805194|NCT01033032|OG002|Outcome|Dose Level 3|Amrubicin -110 mg/m^2 IV every 21days
10805195|NCT01033032|OG003|Outcome|Dose Level 4|Amrubicin -120 mg/m^2 IV every 21 days
10805196|NCT01033032|EG000|Reported Event|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
10805197|NCT01033032|EG001|Reported Event|Dose Level 2|Amrubicin - 100 mg/m^2 by intravenous (IV) every 21 days
10805198|NCT01033032|EG002|Reported Event|Dose Level 3 (MTD)/Phase II|Amrubicin - 110 mg/m^2 by intravenous (IV) every 21 days Includes patients treated at the MTD in Dose Level 3 phase 1 and in phase II
10805199|NCT01033032|EG003|Reported Event|Dose Level 4|Amrubicin - 120 mg/m^2 by intravenous (IV) every 21 days
11204862|NCT02224157|EG000|Reported Event|Placebo Bid + Symbicort 'as Needed' (Experimental)|Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
11204863|NCT02224157|EG001|Reported Event|Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator)|Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4mg 'as needed'
11204864|NCT02224274|BG000|Baseline|Clopidogrel|These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
11204865|NCT02224274|BG001|Baseline|Ticagrelor|These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
11204866|NCT02224274|BG002|Baseline|Total|Total of all reporting groups
10820507|NCT00058552|OG001|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
11204867|NCT02224274|FG000|Participant Flow|Clopidogrel|"These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h.~Clopidogrel"
11204868|NCT02224274|FG001|Participant Flow|Ticagrelor|"These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.~Ticagrelor"
11204869|NCT02224274|OG000|Outcome|Clopidogrel|These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
11204870|NCT02224274|OG001|Outcome|Ticagrelor|These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
11204871|NCT02224274|EG000|Reported Event|Clopidogrel|These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
11204872|NCT02224274|EG001|Reported Event|Ticagrelor|These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
11204873|NCT02224313|BG000|Baseline|Premenopausal Women|Premenopausal women at baseline
11204874|NCT02224313|BG001|Baseline|Postmenopausal Women|Postmenopausal women at baseline
11204875|NCT02224313|BG002|Baseline|Total|Total of all reporting groups
11204876|NCT02224313|FG000|Participant Flow|1.Premenopausal Women|Premenopausal women with no treatment assigned
11204877|NCT02224313|FG001|Participant Flow|2.Postmenopausal Women With Hormones|"Oral hormone therapy will be given to women in this group. Daily dose of oral estradiol 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral estradiol 1 mg and progesterone 100 mg for 14 days will be given during the following 14 days.~oral estradiol 1.0 mg: one tablet of oral estradiol 1.0 mg once a day for 28 days~oral progesterone 100 mg: one tablet of oral progesterone 100 mg once a day for 14 days"
11204878|NCT02224313|OG000|Outcome|Premenopausal Women|Premenopausal women in the study
11204879|NCT02224313|OG001|Outcome|Postmenopausal Women|Postmenopausal women in the study
11204880|NCT02224313|EG000|Reported Event|Premenopausal Women|Premenopausal women in the study
11204881|NCT02224313|EG001|Reported Event|Postmenopausal Women|Postmenopausal women in the study
11204882|NCT02224404|BG000|Baseline|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
11204883|NCT02224404|FG000|Participant Flow|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
11204884|NCT02224404|OG000|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
11204885|NCT02224404|EG000|Reported Event|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
11204886|NCT02224482|BG000|Baseline|Control|Print materials
11204887|NCT02224482|BG001|Baseline|Intervention Group|"PROGRESS~PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors."
11204888|NCT02224482|BG002|Baseline|Total|Total of all reporting groups
11204889|NCT02224482|FG000|Participant Flow|Control|Print materials
11204890|NCT02224482|FG001|Participant Flow|Intervention Group|"PROGRESS~PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors."
11204891|NCT02224482|OG000|Outcome|Control|Print materials
11204892|NCT02224482|OG001|Outcome|Intervention Group|"PROGRESS~PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors."
11204893|NCT02224482|EG000|Reported Event|Control|Print materials
11204894|NCT02224482|EG001|Reported Event|Intervention Group|"PROGRESS~PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors."
11204895|NCT02224508|BG000|Baseline|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
11204896|NCT02224508|BG001|Baseline|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
11204897|NCT02224508|BG002|Baseline|Total|Total of all reporting groups
11204898|NCT02224508|FG000|Participant Flow|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
11204899|NCT02224508|FG001|Participant Flow|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
11204900|NCT02224508|OG000|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
11204901|NCT02224508|OG001|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
11204902|NCT02224508|OG000|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
11204903|NCT02224508|EG000|Reported Event|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
11204904|NCT02224508|EG001|Reported Event|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
11204905|NCT02224560|BG000|Baseline|GWP42003-P 20 mg/kg/Day Dose-ITT Analysis Set|Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 20 mg/kg/day).
11204906|NCT02224560|BG001|Baseline|GWP42003-P 10 mg/kg/Day Dose-ITT Analysis Set|Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 10 mg/kg/day).
10805209|NCT00942331|BG000|Baseline|Arm II (GCB)|Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805210|NCT00942331|BG001|Baseline|Arm I (GCP)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805211|NCT00942331|BG002|Baseline|Total|Total of all reporting groups
10805212|NCT00942331|FG000|Participant Flow|Arm II (GCB)|Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805213|NCT00942331|FG001|Participant Flow|Arm I (GCP)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805214|NCT00942331|OG000|Outcome|Arm II (GCB)|Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805215|NCT00942331|OG001|Outcome|Arm I (GCP)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805216|NCT00942331|EG000|Reported Event|Arm II (GCB)|Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805217|NCT00942331|EG001|Reported Event|Arm I (GCP)|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
10805218|NCT00932737|BG000|Baseline|Placebo|Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805219|NCT00932737|BG001|Baseline|Hyoscine Butylbromide (Buscopan®) 20 mg|Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805220|NCT00932737|BG002|Baseline|Total|Total of all reporting groups
10805221|NCT00932737|FG000|Participant Flow|Placebo|Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805222|NCT00932737|FG001|Participant Flow|Hyoscine Butylbromide (Buscopan®) 20 mg|Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
11204907|NCT02224560|BG002|Baseline|Placebo-ITT Analysis Set|Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (Placebo).
11204908|NCT02224560|BG003|Baseline|Total|Total of all reporting groups
10805223|NCT00932737|OG000|Outcome|Placebo|Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805224|NCT00932737|OG001|Outcome|Hyoscine Butylbromide (Buscopan®) 20 mg|Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805225|NCT00932737|EG000|Reported Event|Placebo|Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805226|NCT00932737|EG001|Reported Event|Hyoscine Butylbromide (Buscopan®) 20 mg|Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
10805227|NCT00893516|BG000|Baseline|1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4|"CHOP chemo therapy + CD4 therapy~CHOP + CD4"
10805228|NCT00893516|BG001|Baseline|2 CHOP Chemotherapy CHOP|"CHOP chemotherapy~CHOP"
10805229|NCT00893516|BG002|Baseline|Total|Total of all reporting groups
10805230|NCT00893516|FG000|Participant Flow|1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4|"CHOP chemo therapy + CD4 therapy~CHOP + CD4"
10805231|NCT00893516|FG001|Participant Flow|2 CHOP Chemotherapy CHOP|"CHOP chemotherapy~CHOP"
10805232|NCT00893516|OG000|Outcome|1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4|"CHOP chemo therapy + CD4 therapy~CHOP + CD4"
10805233|NCT00893516|OG001|Outcome|2 CHOP Chemotherapy CHOP|"CHOP chemotherapy~CHOP"
10805234|NCT00893516|EG000|Reported Event|1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4|"CHOP chemo therapy + CD4 therapy~CHOP + CD4"
10805235|NCT00893516|EG001|Reported Event|2 CHOP Chemotherapy CHOP|"CHOP chemotherapy~CHOP"
10805236|NCT00848757|BG000|Baseline|Intensive Lifestyle Intervention (ILI)|"Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population.~Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population."
10805237|NCT00848757|BG001|Baseline|Usual Care Control|Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
10805238|NCT00848757|BG002|Baseline|Total|Total of all reporting groups
11204909|NCT02224560|FG000|Participant Flow|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the open-label extension (OLE) study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805239|NCT00848757|FG000|Participant Flow|Intensive Lifestyle Intervention (ILI)|"Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population.~Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population."
10805240|NCT00848757|FG001|Participant Flow|Usual Care Control|Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
10805241|NCT00848757|OG000|Outcome|Intensive Lifestyle Intervention (ILI)|"Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population.~Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population."
10805242|NCT00848757|OG001|Outcome|Usual Care Control|Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
10805243|NCT00848757|EG000|Reported Event|Usual Care Control|Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
10820508|NCT00058552|EG000|Reported Event|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
10820509|NCT00058552|EG001|Reported Event|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
11204910|NCT02224560|FG001|Participant Flow|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805244|NCT00848757|EG001|Reported Event|Intensive Lifestyle Intervention (ILI)|"Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population.~Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population."
10805261|NCT00710710|BG000|Baseline|200mg BI 2536 IV on Day 1|200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805262|NCT00710710|BG001|Baseline|60mg BI 2536 IV on Day 1-3|60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805263|NCT00710710|BG002|Baseline|Total|Total of all reporting groups
10805264|NCT00710710|FG000|Participant Flow|200mg BI 2536 IV on Day 1|200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805265|NCT00710710|FG001|Participant Flow|60mg BI 2536 IV on Day 1-3|60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805266|NCT00710710|OG000|Outcome|200mg BI 2536 IV on Day 1|200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805267|NCT00710710|OG001|Outcome|60mg BI 2536 IV on Day 1-3|60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805268|NCT00710710|EG000|Reported Event|200mg BI 2536 IV on Day 1|200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805269|NCT00710710|EG001|Reported Event|60mg BI 2536 IV on Day 1-3|60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
10805270|NCT00608023|BG000|Baseline|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
10805271|NCT00608023|BG001|Baseline|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
10805272|NCT00608023|BG002|Baseline|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
10805273|NCT00608023|BG003|Baseline|Total|Total of all reporting groups
10805274|NCT00608023|FG000|Participant Flow|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 Weeks
10805275|NCT00608023|FG001|Participant Flow|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
10805276|NCT00608023|FG002|Participant Flow|Placebo-Tesamorelin (P-T)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
10805277|NCT00608023|OG000|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
10805278|NCT00608023|OG001|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
10805279|NCT00608023|OG002|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
10805280|NCT00608023|OG000|Outcome|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 weeks
10805281|NCT00608023|OG001|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
10805282|NCT00608023|OG002|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
10805283|NCT00608023|EG000|Reported Event|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
10805284|NCT00608023|EG001|Reported Event|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
10805285|NCT00608023|EG002|Reported Event|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
10805286|NCT00551616|BG000|Baseline|CDB-2914|CDB-2914: Single dose (30 mg)
10805287|NCT00551616|BG001|Baseline|Levonorgestrel|Levonorgestrel: Single dose (1.5 mg)
10805288|NCT00551616|BG002|Baseline|Total|Total of all reporting groups
10805289|NCT00551616|FG000|Participant Flow|CDB-2914|CDB-2914: Single dose (30 mg)
10805290|NCT00551616|FG001|Participant Flow|Levonorgestrel|Levonorgestrel: Single dose (1.5 mg)
10805291|NCT00551616|OG000|Outcome|CDB-2914|CDB-2914: Single dose (30 mg)
10805292|NCT00551616|OG001|Outcome|Levonorgestrel|Levonorgestrel: Single dose (1.5 mg)
10805293|NCT00551616|EG000|Reported Event|CDB-2914|CDB-2914: Single dose (30 mg)
10805294|NCT00551616|EG001|Reported Event|Levonorgestrel|Levonorgestrel: Single dose (1.5 mg)
10805295|NCT00520767|BG000|Baseline|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
10805296|NCT00520767|FG000|Participant Flow|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
10805297|NCT00520767|OG000|Outcome|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
10805298|NCT00520767|EG000|Reported Event|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
10820510|NCT00058825|BG000|Baseline|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
10820511|NCT00058825|FG000|Participant Flow|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
10805299|NCT00492050|BG000|Baseline|All Participants|"Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).~Bortezomib: 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.~Rituximab: 375 mg/m^2 IV on Day 8 and 22.~Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)"
10805300|NCT00492050|FG000|Participant Flow|Bortezomib + Rituximab|"Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).~Bortezomib: 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.~Rituximab: 375 mg/m^2 IV on Day 8 and 22.~Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)"
10805301|NCT00492050|OG000|Outcome|All Participants|"Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).~Bortezomib: 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.~Rituximab: 375 mg/m^2 IV on Day 8 and 22.~Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)"
10805302|NCT00492050|EG000|Reported Event|All Participants|"Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).~Bortezomib: 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.~Rituximab: 375 mg/m^2 IV on Day 8 and 22.~Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)"
10805303|NCT00456261|BG000|Baseline|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
10805304|NCT00456261|BG001|Baseline|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
10805305|NCT00456261|BG002|Baseline|Total|Total of all reporting groups
10805306|NCT00456261|FG000|Participant Flow|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
10805307|NCT00456261|FG001|Participant Flow|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
11244147|NCT02509065|FG016|Participant Flow|145IO, 100B, UC, 115B, 130B, 130IO, 110IO, 110B, 120IO|"Arms were completed in the following order:~145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
10805308|NCT00456261|OG000|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
10805309|NCT00456261|OG001|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
10805310|NCT00456261|EG000|Reported Event|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
10805311|NCT00456261|EG001|Reported Event|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
10805312|NCT00448630|BG000|Baseline|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
10805313|NCT00448630|FG000|Participant Flow|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
10805314|NCT00448630|OG000|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
10805315|NCT00448630|OG000|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
10805316|NCT00448630|OG001|Outcome|Risperidone|risperidone as prescribed by subject's physician
10805317|NCT00448630|OG002|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
10805318|NCT00448630|OG003|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
10805319|NCT00448630|OG004|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
10805320|NCT00448630|OG005|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
10805321|NCT00448630|OG006|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
10805322|NCT00448630|EG000|Reported Event|Ziprasidone|ziprasidone as prescribed by subject's physician
10805323|NCT00448630|EG001|Reported Event|Risperidone|risperidone as prescribed by subject's physician
10805324|NCT00448630|EG002|Reported Event|Quetiapine|quetiapine as prescribed by subject's physician
10805325|NCT00448630|EG003|Reported Event|Olanzipine|olanzipine as prescribed by subject's physician
10805326|NCT00448630|EG004|Reported Event|Aripiprazole|aripiprazole as prescribed by subject's physician
10805327|NCT00448630|EG005|Reported Event|Amisulpride|amisulpride as prescribed by subject's physician
10805328|NCT00448630|EG006|Reported Event|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
10805329|NCT00345345|BG000|Baseline|Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)|10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
10805330|NCT00345345|FG000|Participant Flow|Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)|10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
10805331|NCT00345345|OG000|Outcome|Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)|10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
10805332|NCT00345345|OG000|Outcome|Alemtuzumab in Participants With T Cell Large Granular Lymphocytic Leukemia (T-LGL)|10 mg Alemtuzumab (Campath®; Genzyme) was administered at 10 mg/dose intravenously daily for 10 days over 2 hours, after a 1 mg intravenous test dose.
10805333|NCT00345345|EG000|Reported Event|Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL)|10 mg Alemtuzumab (Campath®; Genzyme) was administered intravenously daily for 10 days, after a 1 mg intravenous test dose.
10805334|NCT00127127|BG000|Baseline|Vorinostat 100 mg|During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805335|NCT00127127|BG001|Baseline|Vorinostat 200 mg|During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805336|NCT00127127|BG002|Baseline|Vorinostat 400 mg|During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805337|NCT00127127|BG003|Baseline|Vorinostat 500 mg|During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)
10805338|NCT00127127|BG004|Baseline|Total|Total of all reporting groups
10805339|NCT00127127|FG000|Participant Flow|Vorinostat 100 mg|During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805340|NCT00127127|FG001|Participant Flow|Vorinostat 200 mg|During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805341|NCT00127127|FG002|Participant Flow|Vorinostat 400 mg|During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
11244148|NCT02509065|FG017|Participant Flow|115B, UC, 130B, 130IO, 145IO, 100B, 110B, 110IO, 120IO|"Arms were completed in the following order:~115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244149|NCT02509065|FG018|Participant Flow|130IO, 130B, 145IO, 100B, 115B, UC, 110IO, 110B, 120IO|"Arms were completed in the following order:~130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244150|NCT02509065|FG019|Participant Flow|100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B, 120IO|"Arms were completed in the following order:~100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244151|NCT02509065|FG020|Participant Flow|UC, 115B, 145IO, 100B, 130B, 130IO, 110B, 110IO, 120|"Arms were completed in the following order:~Usual Care 115 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244152|NCT02509065|FG021|Participant Flow|145IO, 100B, 130B, 130IO, UC, 115B, 110IO, 110B, 120IO|"Arms were completed in the following order:~145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244153|NCT02509065|FG022|Participant Flow|130IO, 130B, 115B, UC, 100B, 145IO, 110B, 110IO, 120IO|"Arms were completed in the following order:~130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas"
11244154|NCT02509065|OG000|Outcome|Usual Care|Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
11244155|NCT02509065|OG001|Outcome|145 mg/dl Set Point - Insulin Only|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
11244156|NCT02509065|OG002|Outcome|130 mg/dl Set Point - Insulin Only|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
11244157|NCT02509065|OG003|Outcome|130 mg/dl Set Point - Bihormonal|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
11244158|NCT02509065|OG004|Outcome|115 mg/dl Set Point - Bihormonal|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
10805342|NCT00127127|FG003|Participant Flow|Vorinostat 500 mg|During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)
11244159|NCT02509065|OG005|Outcome|100 mg/dl Set Point - Bihormonal|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
11244160|NCT02509065|OG006|Outcome|110 mg/dl Set Point - Insulin Only|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10805343|NCT00127127|OG000|Outcome|Vorinostat 100 mg|During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805344|NCT00127127|OG001|Outcome|Vorinostat 200 mg|During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805345|NCT00127127|OG002|Outcome|Vorinostat 400 mg|During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805346|NCT00127127|OG003|Outcome|Vorinostat 500 mg|During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805347|NCT00127127|OG000|Outcome|Vorinostat 100 mg|During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. (Cycle 1 was 26 days.)
10805348|NCT00127127|OG001|Outcome|Vorinostat 200 mg|During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. (Cycle 1 was 26 days.)
10805349|NCT00127127|OG002|Outcome|Vorinostat 400 mg|During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. (Cycle 1 was 26 days.)
10805350|NCT00127127|OG003|Outcome|Vorinostat 500 mg|During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. (Cycle 1 was 26 days.)
10805351|NCT00127127|OG000|Outcome|Vorinostat 100 mg FASTED|Participants received a single oral dose of vorinostat 100 mg in fasted state on Day 1.
10805352|NCT00127127|OG001|Outcome|Vorinostat 200 mg FASTED|Participants received a single oral dose of vorinostat 200 mg in fasted state on Day 1.
10805353|NCT00127127|OG002|Outcome|Vorinostat 400 mg FASTED|Participants received a single oral dose of vorinostat 400 mg in fasted state on Day 1.
10805354|NCT00127127|OG003|Outcome|Vorinostat 500 mg FASTED|Participants received a single oral dose of vorinostat 500 mg in fasted state on Day 1.
10805355|NCT00127127|OG000|Outcome|Vorinostat 100 mg FED|Participants received a single oral dose of vorinostat 100 mg in a fed state on Day 3.
10805356|NCT00127127|OG001|Outcome|Vorinostat 200 mg FED|Participants received a single oral dose of vorinostat 200 mg in a fed state on Day 3.
10805357|NCT00127127|OG002|Outcome|Vorinostat 400 mg FED|Participants received a single oral dose of vorinostat 400 mg in a fed state on Day 3.
10805358|NCT00127127|OG003|Outcome|Vorinostat 500 mg FED|Participants received a single oral dose of vorinostat 500 mg in a fed state on Day 3.
10805359|NCT00127127|OG000|Outcome|Vorinostat 100 mg Twice-daily|Participants received Vorinostat 100 mg twice daily, in the morning and evening, for 14 days (Days 5-18).
10805360|NCT00127127|OG001|Outcome|Vorinostat 200 mg Twice-daily|Participants received vorinostat 200 mg twice daily, in the morning and evening, for 14 days (Days 5-18).
10805361|NCT00127127|OG002|Outcome|Vorinostat 400 mg Once-daily|Participants received vorinostat 400 mg once daily in the morning for 14 days (Days 5-18).
10805362|NCT00127127|OG003|Outcome|Vorinostat 500 mg Once-daily|Participants received vorinostat 500 mg once daily in the morning for 14 days (Days 5-18).
10805363|NCT00127127|OG000|Outcome|Vorinostat 100 mg FASTED|Participants received a single oral dose of vorinostat 100 mg in fasted state on Day 1
10805364|NCT00127127|OG001|Outcome|Vorinostat 200 mg FASTED|Participants received single oral dose of vorinostat 200 mg on Day 1 in a fasted state.
10805365|NCT00127127|OG002|Outcome|Vorinostat 400 mg FASTED|Participants received a single oral dose of vorinostat 400 mg on Day 1 in a fasted state.
10805366|NCT00127127|OG003|Outcome|Vorinostat 500 mg FASTED|Participants received a single oral dose of vorinostat 500 mg on Day 1 in a fasted state.
10805367|NCT00127127|OG000|Outcome|Vorinostat 100 mg FASTED|Participants received a single oral dose of vorinostat 100 mg in a fasted state on Day 1.
10805368|NCT00127127|OG001|Outcome|Vorinostat 200 mg FASTED|Participants received a single oral dose of vorinostat 200 mg in a fasted state on Day 1.
10805369|NCT00127127|OG002|Outcome|Vorinostat 400 mg FASTED|Participants received a single oral dose of vorinostat 400 mg in a fasted state on Day 1.
10805370|NCT00127127|OG003|Outcome|Vorinostat 500 mg FASTED|Participants received a single oral dose of vorinostat 500 mg in a fasted state on Day 1.
10805371|NCT00127127|OG000|Outcome|Vorinostat 100 mg Twice-daily|Participants received vorinostat 100 mg twice daily, in the morning and evening, for 14 days (Days 5-18).
10805372|NCT00127127|OG002|Outcome|Vorinostat 400 mg Once-daily|Participants received vorinostat 400 mg once daily for 14 days (Days 5-18).
10805373|NCT00127127|OG003|Outcome|Vorinostat 500 mg Once-daily|Participants received vorinostat 500 mg once daily for 14 days (Days 5-18).
10805374|NCT00127127|EG000|Reported Event|Vorinostat 100 mg|During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805375|NCT00127127|EG001|Reported Event|Vorinostat 200 mg|During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805376|NCT00127127|EG002|Reported Event|Vorinostat 400 mg|During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805377|NCT00127127|EG003|Reported Event|Vorinostat 500 mg|During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
10805378|NCT00085982|BG000|Baseline|Leptin Treatment|"300 mg of study drug administered via SC injections.~Metreleptin: Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin receptor mutation"
10805379|NCT00085982|FG000|Participant Flow|Leptin Treatment|"300 mg of study drug administered via SC injections.~Metreleptin: Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin receptor mutation"
10805380|NCT00085982|OG000|Outcome|Leptin Treatment|"300 mg of study drug administered via SC injections.~Metreleptin: Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin receptor mutation"
10805381|NCT00085982|EG000|Reported Event|Leptin Treatment|"300 mg of study drug administered via SC injections.~Metreleptin: Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin receptor mutation"
10805382|NCT00061945|BG000|Baseline|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805383|NCT00061945|BG001|Baseline|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805384|NCT00061945|BG002|Baseline|Total|Total of all reporting groups
10805385|NCT00061945|FG000|Participant Flow|Phase I - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 & 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 & 29, MTX IV & IT d1,15 & 19, MTX PO q6 hr d1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 & 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
10805386|NCT00061945|FG001|Participant Flow|Phase II - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 & 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 & 29, MTX IV & IT d 1,15 & 19, MTX PO q6 hr d 1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d 3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 & 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
10805387|NCT00061945|OG000|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805388|NCT00061945|OG000|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805389|NCT00061945|OG001|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805390|NCT00061945|OG000|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description
11204911|NCT02224560|FG002|Participant Flow|Placebo|Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched investigational medicinal product (IMP) group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
11204912|NCT02224560|OG000|Outcome|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805391|NCT00061945|OG001|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description
10805392|NCT00061945|EG000|Reported Event|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805393|NCT00061945|EG001|Reported Event|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
10805394|NCT04018612|BG000|Baseline|High Dose APAP|Acetaminophen (APAP) administered post-operatively at a high dose
11204913|NCT02224560|OG001|Outcome|GWP42003-P 10 mg/kg/Day Dose|Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11204914|NCT02224560|OG002|Outcome|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched IMP group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
11204915|NCT02224560|EG000|Reported Event|GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set|Participants received at least 1 dose of IMP; analyzed as per actual treatment received. Six participants who were assigned to the GWP42003-P 10 mg/kg/day dose received dosing schedules for GWP42003-P 20 mg/kg/day. For safety analyses, these participants were assigned to the GWP42003-P 20 mg/kg/day group.
11204916|NCT02224560|EG001|Reported Event|GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set|Participants received at least 1 dose of IMP; analyzed as per actual treatment received. Six participants who were assigned to the GWP42003-P 10 mg/kg/day dose received dosing schedules for GWP42003-P 20 mg/kg/day. For safety analyses, these participants were assigned to the GWP42003-P 20 mg/kg/day group.
11204917|NCT02224560|EG002|Reported Event|Placebo-Safety Analysis Set|Participants received at least 1 dose of IMP; analyzed as per actual treatment received.
11204918|NCT02224612|BG000|Baseline|All Study Partipants|All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs
11204919|NCT02224612|FG000|Participant Flow|Medline Face Mask First|Medline Face Mask first, then KC Childs Mask
11204920|NCT02224612|FG001|Participant Flow|KC Childs Mask First|KC Childs Mask first, then Medline Face Mask
11204921|NCT02224612|OG000|Outcome|Medline Pediatric Face Mask|All participants Medline Pediatric Face Mask
11204922|NCT02224612|OG001|Outcome|KC Childs Mask|All subjects KC Childs Mask
11204923|NCT02224612|OG000|Outcome|All Particpants|Medline Pediatric Face Mask KC Childs Face Mask
11204924|NCT02224612|OG000|Outcome|All Participants|Medline Pediatric Face Mask KC Childs Face Mask
11204925|NCT02224612|EG000|Reported Event|Medline Pediatric Face Mask|Medline Face Mask
11204926|NCT02224612|EG001|Reported Event|KC Childs Face Mask|KC Face Mask
11204927|NCT02224625|BG000|Baseline|2% CHG, Vehicle, DynaHex, Saline|Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
11204928|NCT02224625|FG000|Participant Flow|2% CHG Cloth, Vehicle, DynaHex, Saline, SLS|Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
11204929|NCT02224625|OG000|Outcome|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
11204930|NCT02224625|OG001|Outcome|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
11204931|NCT02224625|OG002|Outcome|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
11204932|NCT02224625|OG003|Outcome|Saline|"0.9% sodium chloride~Saline: Negative control"
11204933|NCT02224625|OG004|Outcome|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
11204934|NCT02224625|EG000|Reported Event|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
11204935|NCT02224625|EG001|Reported Event|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
11204936|NCT02224625|EG002|Reported Event|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
11204937|NCT02224625|EG003|Reported Event|Saline|"0.9% sodium chloride~Saline: Negative control"
11204938|NCT02224625|EG004|Reported Event|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
11204939|NCT02224638|BG000|Baseline|TheraHoney HD|"Honey product~TheraHoney HD: Honey"
11204940|NCT02224638|BG001|Baseline|SkinTegrity|"Skin moisturizer~SkinTegrity: Hydrogel"
11204941|NCT02224638|BG002|Baseline|Total|Total of all reporting groups
11204942|NCT02224638|FG000|Participant Flow|TheraHoney HD|"Honey product~TheraHoney HD: Honey"
11204943|NCT02224638|FG001|Participant Flow|SkinTegrity|"Skin moisturizer~SkinTegrity: Hydrogel"
11204944|NCT02224638|OG000|Outcome|TheraHoney HD|Honey product
11204945|NCT02224638|OG001|Outcome|SkinTegrity|SkinTegrity: Hydrogel
11204946|NCT02224638|OG000|Outcome|TheraHoney HD|"Honey product~TheraHoney HD: Honey"
11204947|NCT02224638|OG001|Outcome|SkinTegrity|"Skin moisturizer~SkinTegrity: Hydrogel"
11204948|NCT02224638|EG000|Reported Event|TheraHoney HD|"Honey product~TheraHoney HD: Honey"
11204949|NCT02224638|EG001|Reported Event|SkinTegrity|"Skin moisturizer~SkinTegrity: Hydrogel"
11204950|NCT02224664|BG000|Baseline|Overall Study|All participants who received a single oral dose of L-Dopa tablet/capsule (up to a maximum dose of 250 mg, based on investigator's discretion) in lead-in period and/or single oral dose of PF-06649751 tablet (3 mg, 5 mg, 15 mg and 25 mg) in dose escalation period.
11204951|NCT02224664|FG000|Participant Flow|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
11204952|NCT02224664|FG001|Participant Flow|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
11204953|NCT02224664|FG002|Participant Flow|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
10805395|NCT04018612|BG001|Baseline|Low Dose APAP|Acetaminophen (APAP) administered post-operatively at a low dose
10805396|NCT04018612|BG002|Baseline|Placebo|Placebo given post-operatively
10805397|NCT04018612|BG003|Baseline|Total|Total of all reporting groups
10805398|NCT04018612|FG000|Participant Flow|High Dose APAP|Acetaminophen (APAP) administered post-operatively at a high dose
10805399|NCT04018612|FG001|Participant Flow|Low Dose APAP|Acetaminophen (APAP) administered post-operatively at a low dose
10805400|NCT04018612|FG002|Participant Flow|Placebo|Placebo given post-operatively
10805401|NCT04018612|OG000|Outcome|High Dose APAP|Acetaminophen (APAP) administered post-operatively at a high dose
10805402|NCT04018612|OG001|Outcome|Low Dose APAP|Acetaminophen (APAP) administered post-operatively at a low dose
10805403|NCT04018612|OG002|Outcome|Placebo|Placebo given post-operatively
10805404|NCT04018612|EG000|Reported Event|High Dose APAP|Acetaminophen (APAP) administered post-operatively at a high dose
10805405|NCT04018612|EG001|Reported Event|Low Dose APAP|Acetaminophen (APAP) administered post-operatively at a low dose
10805406|NCT04018612|EG002|Reported Event|Placebo|Placebo given post-operatively
10805407|NCT03976648|BG000|Baseline|GLPG1690 600 mg|Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805408|NCT03976648|BG001|Baseline|Placebo|Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805409|NCT03976648|BG002|Baseline|Total|Total of all reporting groups
10805410|NCT03976648|FG000|Participant Flow|GLPG1690 600 mg|Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805411|NCT03976648|FG001|Participant Flow|Placebo|Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805412|NCT03976648|OG000|Outcome|GLPG1690 600 mg|Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805413|NCT03976648|OG001|Outcome|Placebo|Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805414|NCT03976648|EG000|Reported Event|GLPG1690 600 mg|Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805415|NCT03976648|EG001|Reported Event|Placebo|Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
10805416|NCT03944486|BG000|Baseline|On-Track|"One arm feasibility study~Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists."
10805417|NCT03944486|FG000|Participant Flow|OnTrack|"One arm feasibility study~Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists."
10805418|NCT03944486|OG000|Outcome|OnTrack|"One arm feasibility study~Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists."
10805419|NCT03944486|EG000|Reported Event|OnTrack|"One arm feasibility study~Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists."
10820512|NCT00058825|OG000|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
10820513|NCT00058825|OG000|Outcome|Isolex|The Isolex system was used for cell selection.
10820514|NCT00058825|OG001|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
10820515|NCT00058825|EG000|Reported Event|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
10820516|NCT00059202|BG000|Baseline|Ursodeoxycholic Acid|Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
10820517|NCT00059202|BG001|Baseline|Placebo|Placebo for Urso
10820518|NCT00059202|BG002|Baseline|Total|Total of all reporting groups
10820519|NCT00059202|FG000|Participant Flow|Ursodeoxycholic Acid|Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
10820520|NCT00059202|FG001|Participant Flow|Placebo|Placebo for Urso
10820521|NCT00059202|OG000|Outcome|Ursodeoxycholic Acid|Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
10820522|NCT00059202|OG001|Outcome|Placebo|Placebo for Urso
10820523|NCT00059202|OG001|Outcome|Placebo|Placebo or Urso
10820524|NCT00059202|OG000|Outcome|Ursodeoxycholic Acid|"Ursodeoxycholic acid 28-30 mg/kg/day~Ursodeoxycholic Acid: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses"
10820525|NCT00059202|OG001|Outcome|Placebo|Identical placebo
10820526|NCT00059202|EG000|Reported Event|Ursodeoxycholic Acid|Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
10820527|NCT00059202|EG001|Reported Event|Placebo|Placebo for Urso
10820528|NCT00059215|BG000|Baseline|Prasugrel (CS-747) 40 mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
10820529|NCT00059215|BG001|Baseline|Prasugrel (CS-747) 60 mg LD/10 mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
10820530|NCT00059215|BG002|Baseline|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
10805420|NCT03619902|BG000|Baseline|Imsidolimab|Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
10805421|NCT03619902|FG000|Participant Flow|Imsidolimab|Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.
10805422|NCT03619902|OG000|Outcome|Imsidolimab|Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
10805423|NCT03619902|EG000|Reported Event|Imsidolimab|Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
10805424|NCT03617523|BG000|Baseline|Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months|Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805425|NCT03617523|BG001|Baseline|Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years|Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805426|NCT03617523|BG002|Baseline|Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805427|NCT03617523|BG003|Baseline|Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
10805428|NCT03617523|BG004|Baseline|Fluzone High-Dose Vaccine Group 5: >=65 Years|Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805429|NCT03617523|BG005|Baseline|Total|Total of all reporting groups
11244161|NCT02509065|OG007|Outcome|110 mg/dl Set Point - Bihormonal|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10805430|NCT03617523|FG000|Participant Flow|Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months|Participants (aged 6 to less than [<] 36 months) received a 0.25-milliliter (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805431|NCT03617523|FG001|Participant Flow|Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years|Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805432|NCT03617523|FG002|Participant Flow|Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805433|NCT03617523|FG003|Participant Flow|Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
10805434|NCT03617523|FG004|Participant Flow|Fluzone High-Dose Vaccine Group 5: >=65 Years|Participants (aged greater than or equal to [>=] 65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805435|NCT03617523|OG000|Outcome|Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months|Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805436|NCT03617523|OG000|Outcome|Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years|Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805437|NCT03617523|OG001|Outcome|Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805438|NCT03617523|OG002|Outcome|Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
10805439|NCT03617523|OG003|Outcome|Fluzone High-Dose Vaccine Group 5: >=65 Years|Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805440|NCT03617523|OG001|Outcome|Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years|Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805441|NCT03617523|OG000|Outcome|Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805442|NCT03617523|OG001|Outcome|Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
10805443|NCT03617523|OG002|Outcome|Fluzone High-Dose Vaccine Group 5: >=65 Years|Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805444|NCT03617523|OG002|Outcome|Fluzone High-Dose Vaccine Group 5: >=65 Years|"Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.~."
10805445|NCT03617523|EG000|Reported Event|Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months|Participants (aged 6 to <36 months) received a 0.25 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10820531|NCT00059215|BG003|Baseline|Clopidogrel|Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
10820532|NCT00059215|BG004|Baseline|Total|Total of all reporting groups
11244162|NCT02509065|OG008|Outcome|120 mg/dl Set Point - Insulin Only|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
10805446|NCT03617523|EG001|Reported Event|Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years|Participants (aged 3 to <9 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
10805447|NCT03617523|EG002|Reported Event|Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805448|NCT03617523|EG003|Reported Event|Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years|Participants (aged 18 to <65 years) received a 0.5 mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
10805449|NCT03617523|EG004|Reported Event|Fluzone High-Dose Vaccine Group 5: >=65 Years|Participants (aged >=65 years) received a 0.5 mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805450|NCT03546192|BG000|Baseline|Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years|Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805451|NCT03546192|BG001|Baseline|Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older|Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805452|NCT03546192|BG002|Baseline|Total|Total of all reporting groups
10805453|NCT03546192|FG000|Participant Flow|Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years|Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805454|NCT03546192|FG001|Participant Flow|Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older|Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805455|NCT03546192|OG000|Outcome|Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years|Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805456|NCT03546192|OG001|Outcome|Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older|Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805457|NCT03546192|EG000|Reported Event|Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years|Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805458|NCT03546192|EG001|Reported Event|Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older|Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
10805459|NCT03517449|BG000|Baseline|Lenvatinib 20 mg + Pembrolizumab 200 mg|Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10805460|NCT03517449|BG001|Baseline|Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel|Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
10805461|NCT03517449|BG002|Baseline|Total|Total of all reporting groups
10805462|NCT03517449|FG000|Participant Flow|Lenvatinib 20 mg + Pembrolizumab 200 mg|Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10805463|NCT03517449|FG001|Participant Flow|Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel|Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
10805464|NCT03517449|OG000|Outcome|Lenvatinib 20 mg + Pembrolizumab 200 mg|Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10805465|NCT03517449|OG001|Outcome|Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel|Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
10805466|NCT03517449|EG000|Reported Event|Lenvatinib 20 mg + Pembrolizumab 200 mg|Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
10805467|NCT03517449|EG001|Reported Event|Treatment of Physician's Choice: (TPC) Doxorubicin or Paclitaxel|Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
10805468|NCT03470922|BG000|Baseline|Arm A: Relatlimab + Nivolumab|"Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W).~For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg."
10805469|NCT03470922|BG001|Baseline|Arm B: Nivolumab|"Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W).~Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg."
10805470|NCT03470922|BG002|Baseline|Total|Total of all reporting groups
10805471|NCT03470922|FG000|Participant Flow|Arm A: Relatlimab + Nivolumab|"Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W).~For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg."
10805472|NCT03470922|FG001|Participant Flow|Arm B: Nivolumab|"Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W).~Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg."
10805473|NCT03470922|OG000|Outcome|Arm A: Relatlimab + Nivolumab|"Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W).~For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg."
10805474|NCT03470922|OG001|Outcome|Arm B: Nivolumab|"Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W).~Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg."
10805475|NCT03470922|EG000|Reported Event|Arm A: Relatlimab + Nivolumab|"Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W).~For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg."
10805476|NCT03470922|EG001|Reported Event|Arm B: Nivolumab|"Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W).~Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg."
10805477|NCT03308825|BG000|Baseline|Group 1: 6 to < 36 Months|Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805478|NCT03308825|BG001|Baseline|Group 2: 3 to < 9 Years|Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805479|NCT03308825|BG002|Baseline|Group 3: 18 to < 65 Years|Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805480|NCT03308825|BG003|Baseline|Group 4: >= 65 Years|Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805481|NCT03308825|BG004|Baseline|Total|Total of all reporting groups
10805482|NCT03308825|FG000|Participant Flow|Group 1: 6 to < 36 Months|Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805483|NCT03308825|FG001|Participant Flow|Group 2: 3 to < 9 Years|Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805484|NCT03308825|FG002|Participant Flow|Group 3: 18 to < 65 Years|Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805485|NCT03308825|FG003|Participant Flow|Group 4: >= 65 Years|Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805486|NCT03308825|OG000|Outcome|Group 1: 6 to < 36 Months|Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805487|NCT03308825|OG000|Outcome|Group 2: 3 to < 9 Years|Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805488|NCT03308825|OG001|Outcome|Group 3: 18 to < 65 Years|Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805489|NCT03308825|OG002|Outcome|Group 4: >= 65 Years|Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805490|NCT03308825|OG001|Outcome|Group 2: 3 to < 9 Years|Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805491|NCT03308825|OG000|Outcome|Group 3: 18 to < 65 Years|Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805492|NCT03308825|OG001|Outcome|Group 4: >= 65 Years|Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805493|NCT03308825|OG001|Outcome|Group 4: Adults >= 65 Years|Adults >= 65 years of age received an intramuscular 0.5-mL dose of Fluzone High-Dose vaccine on Day 0.
10805494|NCT03308825|EG000|Reported Event|Group 1: 6 to < 36 Months|Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805495|NCT03308825|EG001|Reported Event|Group 2: 3 to < 9 Years|Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
10805496|NCT03308825|EG002|Reported Event|Group 3: 18 to < 65 Years|Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805497|NCT03308825|EG003|Reported Event|Group 4: >= 65 Years|Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805498|NCT02915302|BG000|Baseline|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805499|NCT02915302|BG001|Baseline|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805500|NCT02915302|BG002|Baseline|Total|Total of all reporting groups
10805501|NCT02915302|FG000|Participant Flow|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805502|NCT02915302|FG001|Participant Flow|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805503|NCT02915302|OG000|Outcome|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805504|NCT02915302|OG001|Outcome|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805505|NCT02915302|EG000|Reported Event|Fluzone Quadrivalent Vaccine, 0.25-mL|Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805506|NCT02915302|EG001|Reported Event|Fluzone Quadrivalent Vaccine, 0.5-mL|Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805507|NCT02908269|BG000|Baseline|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805508|NCT02908269|BG001|Baseline|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805509|NCT02908269|BG002|Baseline|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805510|NCT02908269|BG003|Baseline|Total|Total of all reporting groups
10805511|NCT02908269|FG000|Participant Flow|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805512|NCT02908269|FG001|Participant Flow|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805513|NCT02908269|FG002|Participant Flow|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805514|NCT02908269|OG000|Outcome|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805515|NCT02908269|OG000|Outcome|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805516|NCT02908269|OG001|Outcome|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805517|NCT02908269|OG000|Outcome|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805518|NCT02908269|EG000|Reported Event|Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years|Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
10805519|NCT02908269|EG001|Reported Event|Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years|Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
10805520|NCT02908269|EG002|Reported Event|Fluzone High-Dose Vaccine Group 3: ≥ 65 Years|Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
10805521|NCT02744040|BG000|Baseline|EDDI-to-ART <= 30 Days|Participants who started ART within 30 days from the estimated date of infection
10805522|NCT02744040|BG001|Baseline|EDDI-to-ART 31-90 Days|Participants who started ART between 31 and 90 days from the estimated date of infection
10805523|NCT02744040|BG002|Baseline|EDDI-to-ART >90 Days|Participants who started ART more than 90 days from the estimated date of infection
10805524|NCT02744040|BG003|Baseline|Total|Total of all reporting groups
10805525|NCT02744040|FG000|Participant Flow|EDDI-to-ART <= 30 Days|Participants who started ART within 30 days from the estimated date of infection
10805526|NCT02744040|FG001|Participant Flow|EDDI-to-ART 31-90 Days|Participants who started ART between 31 and 90 days from the estimated date of infection
10805527|NCT02744040|FG002|Participant Flow|EDDI-to-ART >90 Days|Participants who started ART more than 90 days from the estimated date of infection
10805528|NCT02744040|OG000|Outcome|EDDI-to-ART <= 30 Days|Participants who started ART within 30 days from the estimated date of infection
10805529|NCT02744040|OG001|Outcome|EDDI-to-ART 31-90 Days|Participants who started ART between 31 and 90 days from the estimated date of infection
10805530|NCT02744040|OG002|Outcome|EDDI-to-ART >90 Days|Participants who started ART more than 90 days from the estimated date of infection
10805531|NCT02744040|EG000|Reported Event|EDDI-to-ART <= 30 Days|Participants who started ART within 30 days from the estimated date of infection
10805532|NCT02744040|EG001|Reported Event|EDDI-to-ART 31-90 Days|Participants who started ART between 31 and 90 days from the estimated date of infection
10805533|NCT02744040|EG002|Reported Event|EDDI-to-ART >90 Days|Participants who started ART more than 90 days from the estimated date of infection
10820533|NCT00059215|FG000|Participant Flow|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
10820534|NCT00059215|FG001|Participant Flow|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
10820535|NCT00059215|FG002|Participant Flow|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
10820536|NCT00059215|FG003|Participant Flow|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
11204954|NCT02224664|FG003|Participant Flow|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
11204955|NCT02224664|FG004|Participant Flow|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
10820537|NCT00059215|OG000|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
10820538|NCT00059215|OG001|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
10820539|NCT00059215|OG002|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
10820540|NCT00059215|OG003|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
10820541|NCT00059215|OG004|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
11204956|NCT02224664|OG000|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
11204957|NCT02224664|OG001|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
11204958|NCT02224664|OG002|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
10820542|NCT00059215|EG000|Reported Event|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
10820543|NCT00059215|EG001|Reported Event|Prasugrel (CS-747) 60-mg LD/10 mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
10820544|NCT00059215|EG002|Reported Event|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
10820545|NCT00059215|EG003|Reported Event|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
10820546|NCT00059228|BG000|Baseline|Estradiol|Estradiol transdermal patch 100mcg
10820547|NCT00059228|BG001|Baseline|Placebo|Placebo transdermal patch
10820548|NCT00059228|BG002|Baseline|Total|Total of all reporting groups
10820549|NCT00059228|FG000|Participant Flow|Estradiol|Estradiol transdermal patch 100mcg
10820550|NCT00059228|FG001|Participant Flow|Placebo|Placebo transdermal patch
10820551|NCT00059228|OG000|Outcome|Estradiol|Estradiol transdermal patch 100mcg
10820552|NCT00059228|OG001|Outcome|Placebo|Placebo transdermal patch
10820553|NCT00059228|EG000|Reported Event|Estradiol|Estradiol transdermal patch 100mcg
10820554|NCT00059228|EG001|Reported Event|Placebo|Placebo transdermal patch
10820555|NCT00059332|BG000|Baseline|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
10820556|NCT00059332|BG001|Baseline|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
10820557|NCT00059332|BG002|Baseline|Total|Total of all reporting groups
10820558|NCT00059332|FG000|Participant Flow|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
10820559|NCT00059332|FG001|Participant Flow|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
10805534|NCT02698826|BG000|Baseline|FiO2 Titration Group|"Rapid FiO2 optimization protocol Protocol for rapid FiO2 optimization: We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential overshoot in FiO2 reduction."
10805535|NCT02698826|FG000|Participant Flow|Adult Patients Resuscitated From Cardiac Arrest|"Rapid FiO2 optimization protocol~Protocol for rapid FiO2 optimization: We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential overshoot in FiO2 reduction."
10805536|NCT02698826|OG000|Outcome|FiO2 Titration|Not analyzed secondary to insufficient samples
10805537|NCT02698826|OG000|Outcome|FiO2 Titration|Single arm
10805538|NCT02698826|OG000|Outcome|FiO2 Titration|Insufficient survivors to analyze.
11204959|NCT02224664|OG003|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
11204960|NCT02224664|OG004|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
11204961|NCT02224664|OG000|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
11204962|NCT02224664|OG001|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
11204963|NCT02224664|OG002|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
11204964|NCT02224664|OG003|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
10805539|NCT02698826|EG000|Reported Event|FiO2 Titration|Single arm
10805540|NCT02617589|BG000|Baseline|Treatment A|nivolumab + radiation therapy(RT)
10805541|NCT02617589|BG001|Baseline|Treatment B|temozolomide (TMZ) + radiation therapy
10805542|NCT02617589|BG002|Baseline|Total|Total of all reporting groups
10805543|NCT02617589|FG000|Participant Flow|Treatment A|nivolumab + radiation therapy(RT)
10805544|NCT02617589|FG001|Participant Flow|Treatment B|temozolomide (TMZ) + radiation therapy
10805545|NCT02617589|OG000|Outcome|Treatment A|nivolumab + radiation Therapy
10805546|NCT02617589|OG001|Outcome|Treatment B|temozolomide (TMZ) + radiation therapy
11204965|NCT02224664|EG000|Reported Event|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
11204966|NCT02224664|EG001|Reported Event|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
11204967|NCT02224664|EG002|Reported Event|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
10805547|NCT02617589|EG000|Reported Event|Treatment A|nivolumab + radiation Therapy
10805548|NCT02617589|EG001|Reported Event|Treatment B|temozolomide (TMZ) + radiation therapy
10805549|NCT02614859|BG000|Baseline|Bicalutamide|Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8
10805550|NCT02614859|BG001|Baseline|Metformin and Bicalutamide|Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
10805551|NCT02614859|BG002|Baseline|Total|Total of all reporting groups
10805552|NCT02614859|FG000|Participant Flow|Bicalutamide|Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8
10805553|NCT02614859|FG001|Participant Flow|Metformin and Bicalutamide|Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
10805554|NCT02614859|OG000|Outcome|Bicalutamide|Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8
11204968|NCT02224664|EG003|Reported Event|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
11204969|NCT02224664|EG004|Reported Event|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
11204970|NCT02224690|BG000|Baseline|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11204971|NCT02224690|BG001|Baseline|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to the 20 mg/kg/day dose, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11204972|NCT02224690|BG002|Baseline|Total|Total of all reporting groups
11204973|NCT02224690|FG000|Participant Flow|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the open-label extension (OLE) study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805555|NCT02614859|OG001|Outcome|Metformin and Bicalutamide|Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
10805556|NCT02614859|OG000|Outcome|Arm A|"Cycles 1-2: Observation without treatment Cycles 3-8: Bicalutamide 50 mg daily continuously to end of study~Bicalutamide: Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32)."
10805557|NCT02614859|OG001|Outcome|Arm B|"Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID~Metformin and Bicalutamide: Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID"
10805558|NCT02614859|EG000|Reported Event|Bicalutamide|Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8
10805559|NCT02614859|EG001|Reported Event|Metformin and Bicalutamide|Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
10805560|NCT02614066|BG000|Baseline|Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805561|NCT02614066|BG001|Baseline|Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805562|NCT02614066|BG002|Baseline|Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805563|NCT02614066|BG003|Baseline|Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805564|NCT02614066|BG004|Baseline|Total|Total of all reporting groups
11204974|NCT02224690|FG001|Participant Flow|Placebo|Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to the 20 mg/kg/day dose, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11204975|NCT02224690|OG000|Outcome|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11204976|NCT02224690|OG001|Outcome|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to the 20 mg/kg/day dose, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
11244163|NCT02509065|OG000|Outcome|130 mg/dl Insulin Only Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10805565|NCT02614066|FG000|Participant Flow|Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) received conditioning chemotherapy (fludarabine 25 mg/m^2 intravenously [IV] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805566|NCT02614066|FG001|Participant Flow|Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805567|NCT02614066|FG002|Participant Flow|Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805568|NCT02614066|FG003|Participant Flow|Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805569|NCT02614066|OG000|Outcome|Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805570|NCT02614066|OG000|Outcome|Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805571|NCT02614066|EG000|Reported Event|Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805572|NCT02614066|EG001|Reported Event|Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805573|NCT02614066|EG002|Reported Event|Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
10805574|NCT02614066|EG003|Reported Event|Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered.
11204977|NCT02224690|EG000|Reported Event|GWP42003-P 20 mg/kg/Day Dose|Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805575|NCT02519348|BG000|Baseline|Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805576|NCT02519348|BG001|Baseline|Parts 2 and 3: Durvalumab 1500 mg|Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10820560|NCT00059332|OG000|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
10805577|NCT02519348|BG002|Baseline|Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg|Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
10805578|NCT02519348|BG003|Baseline|Parts 2 and 3: Tremelimumab 750 mg|Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805579|NCT02519348|BG004|Baseline|Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg|Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805580|NCT02519348|BG005|Baseline|Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg|Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805581|NCT02519348|BG006|Baseline|China Cohort: Durvalumab 20 mg/kg|Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805582|NCT02519348|BG007|Baseline|China Cohort: Tremelimumab 10 mg/kg|Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805583|NCT02519348|BG008|Baseline|China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805584|NCT02519348|BG009|Baseline|Total|Total of all reporting groups
10805585|NCT02519348|FG000|Participant Flow|Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805586|NCT02519348|FG001|Participant Flow|Parts 2 and 3: Durvalumab 1500 mg|Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805587|NCT02519348|FG002|Participant Flow|Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg|Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
10805588|NCT02519348|FG003|Participant Flow|Parts 2 and 3: Tremelimumab 750 mg|Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805589|NCT02519348|FG004|Participant Flow|Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg|Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805590|NCT02519348|FG005|Participant Flow|Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg|Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805591|NCT02519348|FG006|Participant Flow|China Cohort: Durvalumab 20 mg/kg|Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805592|NCT02519348|FG007|Participant Flow|China Cohort: Tremelimumab 10 mg/kg|Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805593|NCT02519348|FG008|Participant Flow|China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805594|NCT02519348|OG000|Outcome|Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805595|NCT02519348|OG000|Outcome|Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805596|NCT02519348|OG001|Outcome|Parts 2 and 3: Durvalumab 1500 mg|Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805597|NCT02519348|OG002|Outcome|Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg|Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
11204978|NCT02224690|EG001|Reported Event|Placebo|Participants received placebo (0 mg/mL CBD), volume matched to the 20 mg/kg/day dose, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
10805598|NCT02519348|OG003|Outcome|Parts 2 and 3: Tremelimumab 750 mg|Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805599|NCT02519348|OG004|Outcome|Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg|Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805600|NCT02519348|OG005|Outcome|Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg|Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805601|NCT02519348|OG006|Outcome|China Cohort: Durvalumab 20 mg/kg|Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805602|NCT02519348|OG007|Outcome|China Cohort: Tremelimumab 10 mg/kg|Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805603|NCT02519348|OG008|Outcome|China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805604|NCT02519348|EG000|Reported Event|Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805605|NCT02519348|EG001|Reported Event|Parts 2 and 3: Durvalumab 1500 mg|Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805606|NCT02519348|EG002|Reported Event|Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg|Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
10805607|NCT02519348|EG003|Reported Event|Parts 2 and 3: Tremelimumab 750 mg|Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805608|NCT02519348|EG004|Reported Event|Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg|Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805609|NCT02519348|EG005|Reported Event|Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg|Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805610|NCT02519348|EG006|Reported Event|China Cohort: Durvalumab 20 mg/kg|Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805611|NCT02519348|EG007|Reported Event|China Cohort: Tremelimumab 10 mg/kg|Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805612|NCT02519348|EG008|Reported Event|China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg|Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
10805613|NCT02429414|BG000|Baseline|Mallinckrodt Double Lumen Tube (DLT)|Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB). Non-Video Double Lumen Tube (DLT): Participant receives non-video double lumen tube (DLT) placement before surgery. Fiberoptic Bronchoscopy (FOB): Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. Under General Anesthesia, the Double Lumen Tube (DLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations.
10805614|NCT02429414|BG001|Baseline|Vivasight Video Double Lumen Tube (VDLT)|Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube. Video Double Lumen Tube (VDLT): Participant receives video double lumen tube (VDLT) placement before surgery. Under General Anesthesia, the Video Double Lumen Tube (VDLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. Prior to insertion, the VDLT was connected to its accompanying external monitor via a mini universal serial bus port.
10805615|NCT02429414|BG002|Baseline|Total|Total of all reporting groups
10805616|NCT02429414|FG000|Participant Flow|Mallinckrodt Double Lumen Tube (DLT)|Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB). Non-Video Double Lumen Tube (DLT): Participant receives non-video double lumen tube (DLT) placement before surgery. Fiberoptic Bronchoscopy (FOB): Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. Under General Anesthesia, the Double Lumen Tube (DLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations.
10805617|NCT02429414|FG001|Participant Flow|Vivasight Video Double Lumen Tube (VDLT)|Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube. Video Double Lumen Tube (VDLT): Participant receives video double lumen tube (VDLT) placement before surgery. Under General Anesthesia, the Video Double Lumen Tube (VDLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. Prior to insertion, the VDLT was connected to its accompanying external monitor via a mini universal serial bus port.
10805618|NCT02429414|OG000|Outcome|Mallinckrodt Double Lumen Tube (DLT)|Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB). Non-Video Double Lumen Tube (DLT): Participant receives non-video double lumen tube (DLT) placement before surgery. Fiberoptic Bronchoscopy (FOB): Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. Under General Anesthesia, the Double Lumen Tube (DLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations.
10805619|NCT02429414|OG001|Outcome|Vivasight Video Double Lumen Tube (VDLT)|Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube. Video Double Lumen Tube (VDLT): Participant receives video double lumen tube (VDLT) placement before surgery. Under General Anesthesia, the Video Double Lumen Tube (VDLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. Prior to insertion, the VDLT was connected to its accompanying external monitor via a mini universal serial bus port.
10805620|NCT02429414|EG000|Reported Event|Mallinckrodt Double Lumen Tube (DLT)|Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB). Non-Video Double Lumen Tube (DLT): Participant receives non-video double lumen tube (DLT) placement before surgery. Fiberoptic Bronchoscopy (FOB): Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. Under General Anesthesia, the Double Lumen Tube (DLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations.
10805621|NCT02429414|EG001|Reported Event|Vivasight Video Double Lumen Tube (VDLT)|Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube. Video Double Lumen Tube (VDLT): Participant receives video double lumen tube (VDLT) placement before surgery. Under General Anesthesia, the Video Double Lumen Tube (VDLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. Prior to insertion, the VDLT was connected to its accompanying external monitor via a mini universal serial bus port.
10805622|NCT02267603|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.~* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV"
10805623|NCT02267603|FG000|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.~* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV"
10805624|NCT02267603|OG000|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.~* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV"
10805625|NCT02267603|EG000|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression* or unacceptable toxicity.~* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV"
10805626|NCT02258659|BG000|Baseline|Single Arm|Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
10805627|NCT02258659|FG000|Participant Flow|Single Arm|Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
10805628|NCT02258659|OG000|Outcome|Single Arm|Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
10805629|NCT02258659|EG000|Reported Event|Single Arm|Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
10805630|NCT02111850|BG000|Baseline|Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2|Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^7 Cells + Interleukin-2
10805631|NCT02111850|BG001|Baseline|Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^7 Cells + Interleukin-2
10805632|NCT02111850|BG002|Baseline|Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^8 Cells + Interleukin-2
10805633|NCT02111850|BG003|Baseline|Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^8 Cells + Interleukin-2
10805634|NCT02111850|BG004|Baseline|Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^9 Cells + Interleukin-2
10805635|NCT02111850|BG005|Baseline|Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^9 Cells + Interleukin-2
10805636|NCT02111850|BG006|Baseline|Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^10 Cells + Interleukin-2
10805637|NCT02111850|BG007|Baseline|Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^10 Cells + Interleukin-2
10805638|NCT02111850|BG008|Baseline|Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^11 Cells + Interleukin-2
10805639|NCT02111850|BG009|Baseline|Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
10805640|NCT02111850|BG010|Baseline|Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
11244164|NCT02509065|OG001|Outcome|130 mg/dl Bihormonal Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10805641|NCT02111850|BG011|Baseline|Total|Total of all reporting groups
10805642|NCT02111850|FG000|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2|Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^7 Cells + Interleukin-2
10805643|NCT02111850|FG001|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^7 Cells + Interleukin-2
10805644|NCT02111850|FG002|Participant Flow|Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^8 Cells + Interleukin-2
10805645|NCT02111850|FG003|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^8 Cells + Interleukin-2
10805646|NCT02111850|FG004|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^9 Cells + Interleukin-2
10805647|NCT02111850|FG005|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^9 Cells + Interleukin-2
10805648|NCT02111850|FG006|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^10 Cells + Interleukin-2
10805649|NCT02111850|FG007|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^10 Cells + Interleukin-2
10805650|NCT02111850|FG008|Participant Flow|Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^11 Cells + Interleukin-2
10805651|NCT02111850|FG009|Participant Flow|Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
10805652|NCT02111850|FG010|Participant Flow|Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
10805653|NCT02111850|OG000|Outcome|All Participants on Phase 1|All participants treated on phase 1 dose level 1-9.
10805654|NCT02111850|OG000|Outcome|Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2|Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^7 Cells + Interleukin-2
10805655|NCT02111850|OG001|Outcome|Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^7 Cells + Interleukin-2
10805656|NCT02111850|OG002|Outcome|Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^8 Cells + Interleukin-2
10805657|NCT02111850|OG003|Outcome|Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^8 Cells + Interleukin-2
10805658|NCT02111850|OG004|Outcome|Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^9 Cells + Interleukin-2
10805659|NCT02111850|OG005|Outcome|Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^9 Cells + Interleukin-2
10805660|NCT02111850|OG006|Outcome|Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^10 Cells + Interleukin-2
11244165|NCT02509065|OG002|Outcome|110 mg/dl Insulin Only Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10805661|NCT02111850|OG007|Outcome|Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^10 Cells + Interleukin-2
11204979|NCT02224703|BG000|Baseline|10 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
11204980|NCT02224703|BG001|Baseline|20 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
11204981|NCT02224703|BG002|Baseline|Placebo Control|Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
11204982|NCT02224703|BG003|Baseline|Total|Total of all reporting groups
11204983|NCT02224703|FG000|Participant Flow|10 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 milligrams/milliliter [mg/mL] cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kilogram (kg)/day dose was defined as 50% of the 20 mg/kg/day dose.
11204984|NCT02224703|FG001|Participant Flow|20 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring).The 20 mg/kg/day dose was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
11204985|NCT02224703|FG002|Participant Flow|Placebo Control|Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
11204986|NCT02224703|OG000|Outcome|10 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 20 mg/kg/day dose.
11204987|NCT02224703|OG001|Outcome|20 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
10805662|NCT02111850|OG008|Outcome|Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^11 Cells + Interleukin-2
11204988|NCT02224703|OG002|Outcome|Placebo Control|Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
11204989|NCT02224703|OG000|Outcome|10 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
11204990|NCT02224703|EG000|Reported Event|10 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
11204991|NCT02224703|EG001|Reported Event|20 mg/kg/Day GWP42003-P|GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
11204992|NCT02224703|EG002|Reported Event|Placebo Control|Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
10805663|NCT02111850|OG009|Outcome|Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
10805664|NCT02111850|OG010|Outcome|Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
10805665|NCT02111850|OG000|Outcome|Phase 1|All participants treated on phase 1 dose level 1-9.
10805666|NCT02111850|EG000|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2|Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^7 Cells + Interleukin-2
10805667|NCT02111850|EG001|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^7 Cells + Interleukin-2
10805668|NCT02111850|EG002|Reported Event|Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^8 Cells + Interleukin-2
10805669|NCT02111850|EG003|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^8 Cells + Interleukin-2
10805670|NCT02111850|EG004|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^9 Cells + Interleukin-2
10805671|NCT02111850|EG005|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^9 Cells + Interleukin-2
10805672|NCT02111850|EG006|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^10 Cells + Interleukin-2
10805673|NCT02111850|EG007|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10^10 Cells + Interleukin-2
10805674|NCT02111850|EG008|Reported Event|Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10^11 Cells + Interleukin-2
10805675|NCT02111850|EG009|Reported Event|Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
10805676|NCT02111850|EG010|Reported Event|Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma|Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
10805677|NCT01983553|BG000|Baseline|CYD Dengue Vaccine Group|Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805678|NCT01983553|BG001|Baseline|Control Group|Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805679|NCT01983553|BG002|Baseline|Total|Total of all reporting groups
10805680|NCT01983553|FG000|Participant Flow|CYD Dengue Vaccine Group|Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805681|NCT01983553|FG001|Participant Flow|Control Group|Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805682|NCT01983553|OG000|Outcome|CYD Dengue Vaccine Group|Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805683|NCT01983553|OG001|Outcome|Control Group|Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805684|NCT01983553|EG000|Reported Event|CYD Dengue Vaccine Group|Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
10805685|NCT01983553|EG001|Reported Event|Control Group|Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
11204993|NCT02224729|BG000|Baseline|Bendamustine, Bortezomib, Dexamethasone (Standard)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.~Bendamustine hydrochloride: Given IV~Bortezomib: Given SC~Dexamethasone: Given PO"
10805686|NCT01760291|BG000|Baseline|WATCHMAN|"WATCHMAN LAA Closure Technology~WATCHMAN LAA Closure Technology"
10805687|NCT01760291|FG000|Participant Flow|WATCHMAN|"WATCHMAN LAA Closure Technology~WATCHMAN LAA Closure Technology"
10805688|NCT01760291|OG000|Outcome|WATCHMAN|"WATCHMAN LAA Closure Technology~WATCHMAN LAA Closure Technology"
10805689|NCT01760291|EG000|Reported Event|WATCHMAN|"WATCHMAN LAA Closure Technology~WATCHMAN LAA Closure Technology"
10805690|NCT01483027|BG000|Baseline|Treatment Group|"Standard of care second-line chemotherapy plus TheraSphere~TheraSphere: yttrium 90 microspheres"
10805691|NCT01483027|BG001|Baseline|Control Group|Standard of care second-line chemotherapy with no added therapy
10805692|NCT01483027|BG002|Baseline|Total|Total of all reporting groups
10805693|NCT01483027|FG000|Participant Flow|Treatment Group|"Standard of care second-line chemotherapy plus TheraSphere~TheraSphere: yttrium 90 microspheres"
10805694|NCT01483027|FG001|Participant Flow|Control Group|Standard of care second-line chemotherapy with no added therapy
10805695|NCT01483027|OG000|Outcome|Treatment Group|"Standard of care second-line chemotherapy plus TheraSphere~TheraSphere: yttrium 90 microspheres"
10805696|NCT01483027|OG001|Outcome|Control Group|Standard of care second-line chemotherapy with no added therapy
10805697|NCT01483027|EG000|Reported Event|Treatment Group|"Standard of care second-line chemotherapy plus TheraSphere~TheraSphere: yttrium 90 microspheres"
10805698|NCT01483027|EG001|Reported Event|Control Group|Standard of care second-line chemotherapy with no added therapy
10805699|NCT01472562|BG000|Baseline|All Patients|Study Treatment Arm
10805700|NCT01472562|FG000|Participant Flow|All Patients|Study Treatment Arm
10805701|NCT01472562|OG000|Outcome|All Patients|Study Treatment Arm
10805702|NCT01472562|EG000|Reported Event|All Patients|Study Treatment Arm
10805703|NCT01379781|BG000|Baseline|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805704|NCT01379781|BG001|Baseline|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805705|NCT01379781|BG002|Baseline|Total|Total of all reporting groups
10805706|NCT01379781|FG000|Participant Flow|Behavioral Intervention for Postpartum Depression|"Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.~Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805707|NCT01379781|FG001|Participant Flow|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805708|NCT01379781|OG000|Outcome|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805709|NCT01379781|OG001|Outcome|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805710|NCT01379781|EG000|Reported Event|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
10805711|NCT01379781|EG001|Reported Event|Treatment As Usual|Referred to Treatment in the Community.
10805712|NCT00135200|BG000|Baseline|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
10805713|NCT00135200|FG000|Participant Flow|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
10805714|NCT00135200|OG000|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
10820561|NCT00059332|OG001|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
10820562|NCT00059332|EG000|Reported Event|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
10805715|NCT00135200|EG000|Reported Event|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
10820563|NCT00059332|EG001|Reported Event|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
10820564|NCT00059475|BG000|Baseline|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
10820565|NCT00059475|BG001|Baseline|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
10820566|NCT00059475|BG002|Baseline|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
10820567|NCT00059475|BG003|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
10820568|NCT00059475|BG004|Baseline|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
10820569|NCT00059475|BG005|Baseline|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
10820570|NCT00059475|BG006|Baseline|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
10820571|NCT00059475|BG007|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
10820572|NCT00059475|BG008|Baseline|Total|Total of all reporting groups
10820573|NCT00059475|FG000|Participant Flow|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
10820574|NCT00059475|FG001|Participant Flow|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
10820575|NCT00059475|FG002|Participant Flow|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
10820576|NCT00059475|FG003|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
10820577|NCT00059475|FG004|Participant Flow|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
10820578|NCT00059475|FG005|Participant Flow|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
10820579|NCT00059475|FG006|Participant Flow|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
10820580|NCT00059475|FG007|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
10820581|NCT00059475|OG000|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
10820582|NCT00059475|OG001|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
10820583|NCT00059475|OG002|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
10820584|NCT00059475|OG003|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
10820585|NCT00059475|OG001|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
10820586|NCT00059475|OG002|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
10820587|NCT00059475|OG003|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
10820588|NCT00059475|OG004|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
10820589|NCT00059475|OG005|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
10820590|NCT00059475|OG006|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
10820591|NCT00059475|OG007|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
10820592|NCT00059475|OG000|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
10805716|NCT02513394|BG000|Baseline|Palbociclib Plus Endocrine Therapy (Arm A)|Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
10805717|NCT02513394|BG001|Baseline|Endocrine Therapy Alone (Arm B)|Standard adjuvant endocrine therapy for a duration of at least 5 years.
10805718|NCT02513394|BG002|Baseline|Total|Total of all reporting groups
10805719|NCT02513394|FG000|Participant Flow|Palbociclib Plus Endocrine Therapy (Arm A)|Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
10805720|NCT02513394|FG001|Participant Flow|Endocrine Therapy Alone (Arm B)|Standard adjuvant endocrine therapy for a duration of at least 5 years.
10805721|NCT02513394|OG000|Outcome|Palbociclib Plus Endocrine Therapy (Arm A)|Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
10805722|NCT02513394|OG001|Outcome|Endocrine Therapy Alone (Arm B)|Standard adjuvant endocrine therapy for a duration of at least 5 years.
10805723|NCT02513394|EG000|Reported Event|Palbociclib Plus Endocrine Therapy (Arm A)|Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
10805724|NCT02513394|EG001|Reported Event|Endocrine Therapy Alone (Arm B)|Standard adjuvant endocrine therapy for a duration of at least 5 years.
10805725|NCT02498132|BG000|Baseline|Behavioral Activation|Behavioral Activation will be administered via Moodivate and will include the following core BA components: (1) psychoeducation, (2) development of individualized values and value-drive activities, (3) scheduling and completing activities, (4) eliciting social support to help complete difficult activities, and (5) rating daily mood and reinforcing treatment utilization. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist in order to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms to increase the sensitivity of BA for individuals with motivational and organizational deficits.
10805726|NCT02498132|BG001|Baseline|Cognitive Behavioral Therapy|"Moodkit (a mobile app utilizing Cognitive Behavioral Therapy techniques) will be used to administer cognitive behavioral therapy which is commonly compared to behavioral activation.~Cognitive Behavioral Therapy (CBT) explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts. CBT is an evidence-based approach for reducing depression."
10805727|NCT02498132|BG002|Baseline|Treatment as Usual|"TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application.~Treatment as Usual: Individuals will be provided with one on one therapy sessions"
10805728|NCT02498132|BG003|Baseline|Total|Total of all reporting groups
10805729|NCT02498132|FG000|Participant Flow|Behavioral Activation|Behavioral Activation will be administered via Moodivate and will include the following core BA components: (1) psychoeducation, (2) development of individualized values and value-drive activities, (3) scheduling and completing activities, (4) eliciting social support to help complete difficult activities, and (5) rating daily mood and reinforcing treatment utilization. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist in order to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms to increase the sensitivity of BA for individuals with motivational and organizational deficits.
10805730|NCT02498132|FG001|Participant Flow|Cognitive Behavioral Therapy|"Moodkit (a mobile app utilizing Cognitive Behavioral Therapy techniques) will be used to administer cognitive behavioral therapy which is commonly compared to behavioral activation.~Cognitive Behavioral Therapy (CBT) explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts. CBT is an evidence-based approach for reducing depression."
10805731|NCT02498132|FG002|Participant Flow|Treatment as Usual|"TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application.~Treatment as Usual: Individuals will be provided with one on one therapy sessions"
10805732|NCT02498132|OG000|Outcome|Behavioral Activation|Behavioral Activation will be administered via Moodivate and will include the following core BA components: (1) psychoeducation, (2) development of individualized values and value-drive activities, (3) scheduling and completing activities, (4) eliciting social support to help complete difficult activities, and (5) rating daily mood and reinforcing treatment utilization. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist in order to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms to increase the sensitivity of BA for individuals with motivational and organizational deficits.
10805733|NCT02498132|OG001|Outcome|Cognitive Behavioral Therapy|"Moodkit (a mobile app utilizing Cognitive Behavioral Therapy techniques) will be used to administer cognitive behavioral therapy which is commonly compared to behavioral activation.~Cognitive Behavioral Therapy (CBT) explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts. CBT is an evidence-based approach for reducing depression."
10805734|NCT02498132|OG002|Outcome|Treatment as Usual|"TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application.~Treatment as Usual: Individuals will be provided with one on one therapy sessions"
10820593|NCT00059475|OG001|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
10820594|NCT00059475|OG002|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
10805735|NCT02498132|EG000|Reported Event|Behavioral Activation|Behavioral Activation will be administered via Moodivate and will include the following core BA components: (1) psychoeducation, (2) development of individualized values and value-drive activities, (3) scheduling and completing activities, (4) eliciting social support to help complete difficult activities, and (5) rating daily mood and reinforcing treatment utilization. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist in order to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms to increase the sensitivity of BA for individuals with motivational and organizational deficits.
10805736|NCT02498132|EG001|Reported Event|Cognitive Behavioral Therapy|"Moodkit (a mobile app utilizing Cognitive Behavioral Therapy techniques) will be used to administer cognitive behavioral therapy which is commonly compared to behavioral activation.~Cognitive Behavioral Therapy (CBT) explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts. CBT is an evidence-based approach for reducing depression."
10805737|NCT02498132|EG002|Reported Event|Treatment as Usual|"TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application.~Treatment as Usual: Individuals will be provided with one on one therapy sessions"
10820595|NCT00059475|OG003|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
10820596|NCT00059475|EG000|Reported Event|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
11204994|NCT02224729|FG000|Participant Flow|Bendamustine, Bortezomib, Dexamethasone (Standard)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.~Bendamustine hydrochloride: Given IV~Bortezomib: Given SC~Dexamethasone: Given PO"
11244166|NCT02509065|OG003|Outcome|110 mg/dl Bihormonal Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
10820597|NCT00059475|EG001|Reported Event|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
10820598|NCT00059475|EG002|Reported Event|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
10820599|NCT00059475|EG003|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
10820600|NCT00059475|EG004|Reported Event|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
10820601|NCT00059475|EG005|Reported Event|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
10820602|NCT00059475|EG006|Reported Event|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
10820603|NCT00059475|EG007|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
10820604|NCT00059787|BG000|Baseline|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
10805738|NCT02450760|BG000|Baseline|Control|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805739|NCT02450760|BG001|Baseline|Social Incentive|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805740|NCT02450760|BG002|Baseline|Total|Total of all reporting groups
10805741|NCT02450760|FG000|Participant Flow|Control|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805742|NCT02450760|FG001|Participant Flow|Social Incentive|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805743|NCT02450760|OG000|Outcome|Control|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805744|NCT02450760|OG001|Outcome|Social Incentive|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805745|NCT02450760|OG000|Outcome|Social Support|Social support intervention group
10805746|NCT02450760|OG001|Outcome|Control|Control group
10805747|NCT02450760|OG000|Outcome|Social Support|Social support intervention arm
10805748|NCT02450760|OG001|Outcome|Control|Control Arm
10805749|NCT02450760|OG000|Outcome|Social Support|Social Support Arm
10805750|NCT02450760|EG000|Reported Event|Control|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805751|NCT02450760|EG001|Reported Event|Social Incentive|"Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week.~Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence"
10805752|NCT02445339|BG000|Baseline|Intervention Arm: XR-NTX+CM|"XR-NTX+CM (Extended Release Naltrexone + Care Management)~XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral."
10805753|NCT02445339|BG001|Baseline|Standard Care Arm|Standard Care/Alcohol-Medical Management (MM) Only
10967035|NCT00891046|FG003|Participant Flow|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967036|NCT00891046|FG004|Participant Flow|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11244167|NCT02509065|EG000|Reported Event|All Enrolled Subjects|All subjects enrolled into the study
10805754|NCT02445339|BG002|Baseline|Total|Total of all reporting groups
11204995|NCT02224729|OG000|Outcome|Bendamustine, Bortezomib, Dexamethasone (Standard)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.~Bendamustine hydrochloride: Given IV~Bortezomib: Given SC~Dexamethasone: Given PO"
10805755|NCT02445339|FG000|Participant Flow|Intervention Arm: XR-NTX+CM|"XR-NTX+CM (Extended Release Naltrexone + Care Management)~XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral."
10805756|NCT02445339|FG001|Participant Flow|Standard Care Arm|Standard Care/Alcohol-Medical Management (MM) Only
10805757|NCT02445339|OG000|Outcome|Intervention Arm: XR-NTX+CM|"XR-NTX+CM (Extended Release Naltrexone + Care Management)~XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral."
10805758|NCT02445339|OG001|Outcome|Standard Care Arm|Standard Care/Alcohol-Medical Management (MM) Only
10805759|NCT02445339|EG000|Reported Event|Intervention Arm: XR-NTX+CM|"XR-NTX+CM (Extended Release Naltrexone + Care Management)~XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral."
10805760|NCT02445339|EG001|Reported Event|Standard Care Arm|Standard Care/Alcohol-Medical Management (MM) Only
10820605|NCT00059787|FG000|Participant Flow|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
10820606|NCT00059787|OG000|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
10820607|NCT00059787|OG000|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
10820608|NCT00059787|EG000|Reported Event|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
10820609|NCT00059839|BG000|Baseline|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820610|NCT00059839|BG001|Baseline|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820611|NCT00059839|BG002|Baseline|Total|Total of all reporting groups
10847542|NCT00283712|OG001|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
10847543|NCT00283712|EG000|Reported Event|Infliximab|Subjects randomized to the Infliximab group
10847544|NCT00283712|EG001|Reported Event|Placebo|Subjects randomized to the Placebo group
10805761|NCT03618056|BG000|Baseline|AIDSVAX® B/E|"Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.~AIDSVAX® B/E: Administered by intramuscular injection"
10805762|NCT03618056|FG000|Participant Flow|AIDSVAX® B/E|"Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.~AIDSVAX® B/E: Administered by intramuscular injection"
10805763|NCT03618056|OG000|Outcome|AIDSVAX® B/E|"Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.~AIDSVAX® B/E: Administered by intramuscular injection"
10805764|NCT03618056|EG000|Reported Event|AIDSVAX® B/E|"Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.~AIDSVAX® B/E: Administered by intramuscular injection"
10805765|NCT03503617|BG000|Baseline|RehabTouch Exercise Program|"Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.~RehabTouch: Exercise using the motion sensing devices and a computer"
10805766|NCT03503617|BG001|Baseline|Conventional Tabletop Exercise Program|"Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.~Conventional tabletop exercise program: Exercise following printed sheets of exercises"
10805767|NCT03503617|BG002|Baseline|Total|Total of all reporting groups
10805768|NCT03503617|FG000|Participant Flow|RehabTouch Exercise Program|"Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.~RehabTouch: Exercise using the motion sensing devices and a computer"
10805769|NCT03503617|FG001|Participant Flow|Conventional Tabletop Exercise Program|"Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.~Conventional tabletop exercise program: Exercise following printed sheets of exercises"
10805770|NCT03503617|OG000|Outcome|RehabTouch Exercise Program|"Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.~RehabTouch: Exercise using the motion sensing devices and a computer"
10805771|NCT03503617|OG001|Outcome|Conventional Tabletop Exercise Program|"Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.~Conventional tabletop exercise program: Exercise following printed sheets of exercises"
10805772|NCT03503617|EG000|Reported Event|RehabTouch Exercise Program|"Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.~RehabTouch: Exercise using the motion sensing devices and a computer"
10805773|NCT03503617|EG001|Reported Event|Conventional Tabletop Exercise Program|"Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.~Conventional tabletop exercise program: Exercise following printed sheets of exercises"
10805774|NCT03298867|BG000|Baseline|Placebo|Eight infusions of placebo q3W for a total of 21 weeks.
11244168|NCT02509078|BG000|Baseline|Early Neuromuscular Blockade (NMB)|"Patients will receive cisatracurium besylate for the first 48 hours of the trial.~cisatracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade."
10805775|NCT03298867|BG001|Baseline|Teprotumumab 20 mg/kg|Eight infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
10805776|NCT03298867|BG002|Baseline|Total|Total of all reporting groups
10805777|NCT03298867|FG000|Participant Flow|Placebo|Eight infusions of placebo every 3 weeks (q3W) for a total of 21 weeks.
10805778|NCT03298867|FG001|Participant Flow|Teprotumumab 20 mg/kg|Eight infusions of teprotumumab every q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
10805779|NCT03298867|OG000|Outcome|Placebo|Eight infusions of placebo q3W for a total of 21 weeks.
10805780|NCT03298867|OG001|Outcome|Teprotumumab 20 mg/kg|Eight infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
10805781|NCT03298867|EG000|Reported Event|Placebo|Eight infusions of placebo q3W for a total of 21 weeks.
10805782|NCT03298867|EG001|Reported Event|Teprotumumab 20 mg/kg|Eight infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions.
10805783|NCT03227224|BG000|Baseline|Placebo|Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805784|NCT03227224|BG001|Baseline|Seltorexant 10 mg|Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805785|NCT03227224|BG002|Baseline|Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805786|NCT03227224|BG003|Baseline|Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805787|NCT03227224|BG004|Baseline|Total|Total of all reporting groups
10805788|NCT03227224|FG000|Participant Flow|Placebo|Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805789|NCT03227224|FG001|Participant Flow|Seltorexant 10 mg|Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805790|NCT03227224|FG002|Participant Flow|Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805791|NCT03227224|FG003|Participant Flow|Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805792|NCT03227224|OG000|Outcome|Placebo|Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805793|NCT03227224|OG001|Outcome|Seltorexant 10 mg|Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805794|NCT03227224|OG002|Outcome|Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805795|NCT03227224|OG003|Outcome|Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805796|NCT03227224|OG000|Outcome|Seltorexant 10 mg|Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805797|NCT03227224|OG001|Outcome|Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805798|NCT03227224|OG002|Outcome|Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805799|NCT03227224|EG000|Reported Event|Placebo|Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805800|NCT03227224|EG001|Reported Event|Double-blind: Seltorexant 10 mg|Participants in the double-blind treatment period received Seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805801|NCT03227224|EG002|Reported Event|Double-blind: Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805802|NCT03227224|EG003|Reported Event|DB: Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10967037|NCT00891046|OG000|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967038|NCT00891046|OG001|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
10967039|NCT00891046|OG000|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued anakinra due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10805803|NCT03227224|EG004|Reported Event|Follow-up: Placebo|Participants in the double-blind treatment period received matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805804|NCT03227224|EG005|Reported Event|Follow-up: Seltorexant 10 mg|Participants in the double-blind treatment period received seltorexant 10 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805805|NCT03227224|EG006|Reported Event|Follow-up: Seltorexant 20 mg|Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805806|NCT03227224|EG007|Reported Event|Follow-up: Seltorexant 40 mg|Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).
10805807|NCT03220581|BG000|Baseline|Referral for Care|"Referral for mental health issues and family support services~Referral for care: referral for addictions support"
10805808|NCT03220581|BG001|Baseline|Behavioral Therapy|"8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805809|NCT03220581|BG002|Baseline|Total|Total of all reporting groups
10805810|NCT03220581|FG000|Participant Flow|Referral for Care|"Referral for mental health issues and family support services~Referral for care: referral for addictions support"
10805811|NCT03220581|FG001|Participant Flow|Behavioral Therapy|"8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805812|NCT03220581|OG000|Outcome|Behavioral Therapy|"6 session behavioral therapy intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805813|NCT03220581|OG000|Outcome|Referral for Care|"Referral for mental health issues and family support services~Referral for care: referral for addictions support"
10805814|NCT03220581|OG001|Outcome|Behavioral Therapy|"6 session behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805815|NCT03220581|OG001|Outcome|Behavioral Therapy|"8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805816|NCT03220581|EG000|Reported Event|Referral for Care|"Referral for mental health issues and family support services~Referral for care: referral for addictions support"
10805817|NCT03220581|EG001|Reported Event|Behavioral Therapy|"8-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors~Referral for care: referral for addictions support~Behavioral therapy: therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills"
10805818|NCT03099486|BG000|Baseline|Regorafenib + 5FU/LV Treatment Arm|"Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.~5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours~Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,"
11244169|NCT02509078|BG001|Baseline|Control: No Routine Early NMB|Use of non-study NMB will be discouraged.
10805819|NCT03099486|FG000|Participant Flow|Regorafenib + 5FU/LV Treatment Arm|"Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.~5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours~Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,"
10805820|NCT03099486|OG000|Outcome|Regorafenib + 5FU/LV Treatment Arm|"Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.~5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours~Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,"
10805821|NCT03099486|EG000|Reported Event|Regorafenib + 5FU/LV Treatment Arm|"Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.~5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours~Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,"
10847545|NCT00283803|BG000|Baseline|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
10847546|NCT00283803|FG000|Participant Flow|Exisulind|"Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.~Exisulind: Exisulind 125 mg"
11244170|NCT02509078|BG002|Baseline|Total|Total of all reporting groups
10805822|NCT02991482|BG000|Baseline|Pembrolizumab Arm|"Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.~Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection."
10805823|NCT02991482|BG001|Baseline|Standard Chemotherapy Arm|"Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.~Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.~Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide).~Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis."
10805824|NCT02991482|BG002|Baseline|Total|Total of all reporting groups
10805825|NCT02991482|FG000|Participant Flow|Pembrolizumab Arm|"Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.~Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection."
10805826|NCT02991482|FG001|Participant Flow|Standard Chemotherapy Arm|"Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.~Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.~Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide).~Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis."
10805827|NCT02991482|OG000|Outcome|Pembrolizumab Arm|"Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.~Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection."
10805828|NCT02991482|OG001|Outcome|Standard Chemotherapy Arm|"Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.~Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.~Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide).~Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis."
10805829|NCT02991482|EG000|Reported Event|Pembrolizumab Arm|"Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.~Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection."
10967040|NCT00891046|OG001|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967041|NCT00891046|OG002|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11244171|NCT02509078|FG000|Participant Flow|Early Neuromuscular Blockade (NMB)|"Patients will receive cisatracurium besylate for the first 48 hours of the trial.~cisatracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade."
11244172|NCT02509078|FG001|Participant Flow|Control: No Routine Early NMB|Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
11244173|NCT02509078|OG000|Outcome|Early Neuromuscular Blockade (NMB)|"Patients will receive cisatracurium besylate for the first 48 hours of the trial.~cisatracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade."
11244174|NCT02509078|OG001|Outcome|Control: No Routine Early NMB|Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
11244175|NCT02509078|OG001|Outcome|Control: No Routine Early NMB|Use of non-study NMB will be discouraged.
11244176|NCT02509078|OG000|Outcome|Early Neuromuscular Blockade (NMB)|"Patients will receive cisastracurium besylate for the first 48 hours of the trial.~cisastracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisastracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade."
11244177|NCT02509078|EG000|Reported Event|Early Neuromuscular Blockade (NMB)|"Patients will receive cisastracurium besylate for the first 48 hours of the trial.~cisastracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisastracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade."
11244178|NCT02509078|EG001|Reported Event|Control: No Routine Early NMB|Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
11244179|NCT02509117|BG000|Baseline|Part A- PF-06751979: 3 mg, 12 mg, 40 mg, Placebo|Participants received 3 milligram (mg) oral solution of PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by placebo matched to PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244180|NCT02509117|BG001|Baseline|Part A- PF-06751979: 3 mg, 12 mg, Placebo, PF-06751979 160 mg|Participants received 3 mg oral solution of PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244181|NCT02509117|BG002|Baseline|Part A- PF-06751979: 3 mg, Placebo, PF-06751979: 40 mg, 160 mg|Participants received 3 mg oral solution of PF-06751979 on Day 1 of intervention period 1 followed by placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244182|NCT02509117|BG003|Baseline|Part A: Placebo, PF-06751979: 12 mg, 40 mg, 160 mg|Participants received placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244183|NCT02509117|BG004|Baseline|Part B- Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244184|NCT02509117|BG005|Baseline|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244185|NCT02509117|BG006|Baseline|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244186|NCT02509117|BG007|Baseline|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244187|NCT02509117|BG008|Baseline|Part C: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244188|NCT02509117|BG009|Baseline|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244189|NCT02509117|BG010|Baseline|Total|Total of all reporting groups
11244190|NCT02509117|FG000|Participant Flow|Part A- PF-06751979: 3 mg, 12 mg, 40 mg, Placebo|Participants received 3 milligram (mg) oral solution of PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by placebo matched to PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
10805830|NCT02991482|EG001|Reported Event|Standard Chemotherapy Arm|"Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.~Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.~Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide).~Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis."
10805831|NCT02768870|BG000|Baseline|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10805832|NCT02768870|FG000|Participant Flow|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10805833|NCT02768870|OG000|Outcome|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10805834|NCT02768870|EG000|Reported Event|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10820612|NCT00059839|FG000|Participant Flow|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820613|NCT00059839|FG001|Participant Flow|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820614|NCT00059839|OG000|Outcome|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820615|NCT00059839|OG001|Outcome|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820616|NCT00059839|EG000|Reported Event|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10820617|NCT00059839|EG001|Reported Event|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
10967042|NCT00891046|OG003|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to anakinra, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10805835|NCT02648698|BG000|Baseline|Antibiotic Group|"This group received antibiotic therapy~Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group"
10805836|NCT02648698|BG001|Baseline|Control Group|This group did not receive antibiotic therapy
10805837|NCT02648698|BG002|Baseline|Total|Total of all reporting groups
10805838|NCT02648698|FG000|Participant Flow|Antibiotic Group|"This group received antibiotic therapy~Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group"
10805839|NCT02648698|FG001|Participant Flow|Control Group|This group did not receive antibiotic therapy
10805840|NCT02648698|OG000|Outcome|Antibiotic Group|"This group received antibiotic therapy~Women who were randomized to the treatment group were given oral Levofloxacin 500 mg and Tinidazole 1000 mg daily for 14 days."
10805841|NCT02648698|OG001|Outcome|Control Group|Women who were randomized to the control group did not receive any antibiotic.
10805842|NCT02648698|EG000|Reported Event|Antibiotic Group|"This group received antibiotic therapy~Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group"
10805843|NCT02648698|EG001|Reported Event|Control Group|This group did not receive antibiotic therapy
10805844|NCT02432196|BG000|Baseline|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10805845|NCT02432196|FG000|Participant Flow|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
10805846|NCT02432196|OG000|Outcome|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
11092245|NCT01538199|EG000|Reported Event|TLT Treatment Group 1|"The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks~Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
10805847|NCT02432196|EG000|Reported Event|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10805848|NCT02340676|BG000|Baseline|ECP Plus IL-2|"Extracorporeal Photopheresis (ECP) standard-of-care~Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle~Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks~Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16"
10805849|NCT02340676|FG000|Participant Flow|ECP Plus IL-2|"Extracorporeal Photopheresis (ECP) standard-of-care~Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle~Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks~Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16"
10805850|NCT02340676|OG000|Outcome|ECP Plus IL-2|"Extracorporeal Photopheresis (ECP) standard-of-care~Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle~Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks~Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16"
10805851|NCT02340676|EG000|Reported Event|ECP Plus IL-2|"Extracorporeal Photopheresis (ECP) standard-of-care~Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle~Extracorporeal Photopheresis (ECP): Participants receive ECP treatment twice a week for 16 weeks~Interleukin-2: Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16"
10805852|NCT02000882|BG000|Baseline|BKM120 Plus Capecitabine|"BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.~For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.~BKM120~capecitabine~Trastuzumab"
10805853|NCT02000882|FG000|Participant Flow|BKM120 Plus Capecitabine|"BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.~For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.~BKM120~capecitabine~Trastuzumab"
10805854|NCT02000882|OG000|Outcome|BKM120 Plus Capecitabine|"BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.~For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.~BKM120~capecitabine~Trastuzumab"
10805855|NCT02000882|EG000|Reported Event|BKM120 Plus Capecitabine|"BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.~For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.~BKM120~capecitabine~Trastuzumab"
10805856|NCT01654315|BG000|Baseline|Experimental: Myomo Only Group|"Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805857|NCT01654315|BG001|Baseline|Experimental: Myomo + RTP Group|"Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805858|NCT01654315|BG002|Baseline|Active Comparator: RTP Group|"Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805859|NCT01654315|BG003|Baseline|Total|Total of all reporting groups
10805860|NCT01654315|FG000|Participant Flow|Experimental: Myomo Only Group|"Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805861|NCT01654315|FG001|Participant Flow|Experimental: Myomo + RTP Group|"Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805862|NCT01654315|FG002|Participant Flow|Active Comparator: RTP Group|"Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805863|NCT01654315|OG000|Outcome|Experimental: Myomo Only Group|"Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805864|NCT01654315|OG001|Outcome|Experimental: Myomo + RTP Group|"Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805865|NCT01654315|OG002|Outcome|Active Comparator: RTP Group|"Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805866|NCT01654315|EG000|Reported Event|Experimental: Myomo Only Group|"Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805867|NCT01654315|EG001|Reported Event|Experimental: Myomo + RTP Group|"Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805868|NCT01654315|EG002|Reported Event|Active Comparator: RTP Group|"Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period.~Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period."
10805869|NCT01642004|BG000|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805870|NCT01642004|BG001|Baseline|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805871|NCT01642004|BG002|Baseline|Total|Total of all reporting groups
10805872|NCT01642004|FG000|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805873|NCT01642004|FG001|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805874|NCT01642004|OG000|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805875|NCT01642004|OG001|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805876|NCT01642004|EG000|Reported Event|NIVOLUMAB|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10967043|NCT00891046|OG000|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued tocilizumab due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10805877|NCT01642004|EG001|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
10805878|NCT01366092|BG000|Baseline|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
10805879|NCT01366092|FG000|Participant Flow|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
10805880|NCT01366092|OG000|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
10805881|NCT01366092|EG000|Reported Event|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
11244191|NCT02509117|FG001|Participant Flow|Part A- PF-06751979: 3 mg, 12 mg, Placebo, PF-06751979 160 mg|Participants received 3 mg oral solution of PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244192|NCT02509117|FG002|Participant Flow|Part A- PF-06751979: 3 mg, Placebo, PF-06751979: 40 mg, 160 mg|Participants received 3 mg oral solution of PF-06751979 on Day 1 of intervention period 1 followed by placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244193|NCT02509117|FG003|Participant Flow|Part A: Placebo, PF-06751979: 12 mg, 40 mg, 160 mg|Participants received placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by 12 mg oral suspension of PF-06751979 on Day 1 of intervention period 2 followed by 40 mg oral suspension of PF-06751979 on Day 1 of intervention period 3 followed by 160 mg oral suspension of PF-06751979 on Day 1 of intervention period 4. After completion of period 4, participants were followed for 10 days. A washout period of at least 7 days was maintained between each intervention period.
11244194|NCT02509117|FG004|Participant Flow|Part B- Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244195|NCT02509117|FG005|Participant Flow|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244196|NCT02509117|FG006|Participant Flow|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10805882|NCT01326104|BG000|Baseline|Group A|"High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805883|NCT01326104|BG001|Baseline|Group B|"NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805884|NCT01326104|BG002|Baseline|Total|Total of all reporting groups
10805885|NCT01326104|FG000|Participant Flow|Group A|"High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805886|NCT01326104|FG001|Participant Flow|Group B|"NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805887|NCT01326104|OG000|Outcome|Group A|"High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
11244197|NCT02509117|FG007|Participant Flow|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244198|NCT02509117|FG008|Participant Flow|Part C: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244199|NCT02509117|FG009|Participant Flow|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244200|NCT02509117|OG000|Outcome|Part A: Placebo|Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244201|NCT02509117|OG001|Outcome|Part A: PF-06751979 3 mg|Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244202|NCT02509117|OG002|Outcome|Part A: PF-06751979 12 mg|Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244203|NCT02509117|OG003|Outcome|Part A: PF-06751979 40 mg|Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244204|NCT02509117|OG004|Outcome|Part A: PF-06751979 160 mg|Participants received 160 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244205|NCT02509117|OG005|Outcome|Part B: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244206|NCT02509117|OG006|Outcome|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244207|NCT02509117|OG007|Outcome|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10805888|NCT01326104|OG001|Outcome|Group B|"NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805889|NCT01326104|EG000|Reported Event|Group A|"High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805890|NCT01326104|EG001|Reported Event|Group B|"NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.~TTRNA-xALT: TTRNA-xALT 3 x 10^7/kg by intravenous injection once.~TTRNA-DCs: TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses."
10805891|NCT01244815|BG000|Baseline|Placebo|Participants receive placebo BID for 21 days.
10805892|NCT01244815|BG001|Baseline|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
10805893|NCT01244815|BG002|Baseline|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
10805894|NCT01244815|BG003|Baseline|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
10805895|NCT01244815|BG004|Baseline|Total|Total of all reporting groups
10805896|NCT01244815|FG000|Participant Flow|Placebo|Participants receive placebo twice daily (BID) for 21 days.
10805897|NCT01244815|FG001|Participant Flow|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
10805898|NCT01244815|FG002|Participant Flow|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
10805899|NCT01244815|FG003|Participant Flow|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
10805900|NCT01244815|OG000|Outcome|Placebo|Participants receive placebo BID for 21 days.
10805901|NCT01244815|OG001|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
10805902|NCT01244815|OG002|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
10805903|NCT01244815|OG003|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
10805904|NCT01244815|EG000|Reported Event|Placebo|Participants receive placebo BID for 21 days.
10805905|NCT01244815|EG001|Reported Event|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
10805906|NCT01244815|EG002|Reported Event|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
10805907|NCT01244815|EG003|Reported Event|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
10805908|NCT01142596|BG000|Baseline|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
11092246|NCT01538199|EG001|Reported Event|TLT Treatment Group 2|"The sham group will receive 2 treatments of the sham device per week for 8 weeks~Sham device: The sham device does not emit near-infrared radiation."
11244208|NCT02509117|OG008|Outcome|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244209|NCT02509117|OG009|Outcome|Part C: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244210|NCT02509117|OG010|Outcome|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244211|NCT02509117|OG000|Outcome|Part B: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244212|NCT02509117|OG001|Outcome|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10805909|NCT01142596|BG001|Baseline|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805910|NCT01142596|BG002|Baseline|Total|Total of all reporting groups
10805911|NCT01142596|FG000|Participant Flow|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124 (NCT01098110), and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805912|NCT01142596|FG001|Participant Flow|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805913|NCT01142596|OG000|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805914|NCT01142596|OG001|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805915|NCT01142596|EG000|Reported Event|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805916|NCT01142596|EG001|Reported Event|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
10805917|NCT01098110|BG000|Baseline|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
10805918|NCT01098110|BG001|Baseline|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
10805919|NCT01098110|BG002|Baseline|Placebo BID|Participants received matching placebo BID for 6 weeks.
10805920|NCT01098110|BG003|Baseline|Total|Total of all reporting groups
10805921|NCT01098110|FG000|Participant Flow|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.
10805922|NCT01098110|FG001|Participant Flow|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
10805923|NCT01098110|FG002|Participant Flow|Placebo BID|Participants received matching placebo BID for 6 weeks.
11092247|NCT01538199|EG002|Reported Event|Pilot Study Treatment Group 1|"The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11244213|NCT02509117|OG002|Outcome|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244214|NCT02509117|OG003|Outcome|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10805924|NCT01098110|OG000|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
10805925|NCT01098110|OG001|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
10805926|NCT01098110|OG002|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
10805927|NCT01098110|EG000|Reported Event|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
10805928|NCT01098110|EG001|Reported Event|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
10805929|NCT01098110|EG002|Reported Event|Placebo BID|Participants received matching placebo BID for 6 weeks.
10805930|NCT01006265|BG000|Baseline|Ponesimod 40 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
10805931|NCT01006265|BG001|Baseline|Ponesimod 20 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
10805932|NCT01006265|BG002|Baseline|Ponesimod 10 mg|Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
11092248|NCT01538199|EG003|Reported Event|Pilot Study Treatment Group 2|"The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.~(see protocol change 10/28/2014)"
11244215|NCT02509117|OG004|Outcome|Part C: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10805933|NCT01006265|BG003|Baseline|Placebo|Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
10805934|NCT01006265|BG004|Baseline|Total|Total of all reporting groups
10805935|NCT01006265|FG000|Participant Flow|Ponesimod 40 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
10805936|NCT01006265|FG001|Participant Flow|Ponesimod 20 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
10805937|NCT01006265|FG002|Participant Flow|Ponesimod 10 mg|Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
10805938|NCT01006265|FG003|Participant Flow|Placebo|Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
10805939|NCT01006265|OG000|Outcome|Ponesimod 40 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
10805940|NCT01006265|OG001|Outcome|Ponesimod 20 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
10805941|NCT01006265|OG002|Outcome|Ponesimod 10 mg|Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
10805942|NCT01006265|OG003|Outcome|Placebo|Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
10805943|NCT01006265|EG000|Reported Event|Ponesimod 40 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
10805944|NCT01006265|EG001|Reported Event|Ponesimod 20 mg|Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
10805945|NCT01006265|EG002|Reported Event|Ponesimod 10 mg|Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
10805946|NCT01006265|EG003|Reported Event|Placebo|Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
10805947|NCT00591227|BG000|Baseline|Aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
10805948|NCT00591227|BG001|Baseline|Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
10805949|NCT00591227|BG002|Baseline|Total|Total of all reporting groups
10805950|NCT00591227|FG000|Participant Flow|Aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER (emergency room) evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
10805951|NCT00591227|FG001|Participant Flow|Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
10805952|NCT00591227|OG000|Outcome|Aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
10805953|NCT00591227|OG001|Outcome|Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
10820618|NCT00060008|BG000|Baseline|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
10820619|NCT00060008|FG000|Participant Flow|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
11244216|NCT02509117|OG005|Outcome|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244217|NCT02509117|OG000|Outcome|Part A: PF-06751979 3 mg|Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244218|NCT02509117|OG001|Outcome|Part A: PF-06751979 12 mg|Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10805954|NCT00591227|OG000|Outcome|Aspart Detemir|"these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.~insulin aspart: insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.~If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.~insulin detemir: insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.~If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating."
10805955|NCT00591227|EG000|Reported Event|Aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
10805956|NCT00591227|EG001|Reported Event|Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
10805957|NCT00534976|BG000|Baseline|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
10805958|NCT00534976|BG001|Baseline|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
10805959|NCT00534976|BG002|Baseline|Total|Total of all reporting groups
10805960|NCT00534976|FG000|Participant Flow|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
10805961|NCT00534976|FG001|Participant Flow|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
10805962|NCT00534976|OG000|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
10805963|NCT00534976|OG001|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
10805964|NCT00534976|EG000|Reported Event|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
10805965|NCT00534976|EG001|Reported Event|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
10805966|NCT00337675|BG000|Baseline|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10820620|NCT00060008|OG000|Outcome|SUVmax < 2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
10805967|NCT00337675|BG001|Baseline|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805968|NCT00337675|BG002|Baseline|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805969|NCT00337675|BG003|Baseline|Total|Total of all reporting groups
10805970|NCT00337675|FG000|Participant Flow|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805971|NCT00337675|FG001|Participant Flow|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805972|NCT00337675|FG002|Participant Flow|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805973|NCT00337675|OG000|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805974|NCT00337675|OG001|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805975|NCT00337675|OG002|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805976|NCT00337675|EG000|Reported Event|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805977|NCT00337675|EG001|Reported Event|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805978|NCT00337675|EG002|Reported Event|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
10805979|NCT00317772|BG000|Baseline|Phase 1 Dose Level 1|Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805980|NCT00317772|BG001|Baseline|Phase 1 Dose Level 2|Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805981|NCT00317772|BG002|Baseline|Phase 1 Dose Level 3|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805982|NCT00317772|BG003|Baseline|Expansion Phase|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805983|NCT00317772|BG004|Baseline|Total|Total of all reporting groups
10805984|NCT00317772|FG000|Participant Flow|Phase 1 Dose Level 1|Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805985|NCT00317772|FG001|Participant Flow|Phase 1 Dose Level 2|Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
11204996|NCT02224729|EG000|Reported Event|Bendamustine, Bortezomib, Dexamethasone (Standard)|"Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.~Bendamustine hydrochloride: Given IV~Bortezomib: Given SC~Dexamethasone: Given PO"
10805986|NCT00317772|FG002|Participant Flow|Phase 1 Dose Level 3|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805987|NCT00317772|FG003|Participant Flow|Expansion Phase|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805988|NCT00317772|OG000|Outcome|Phase 1 Dose Level 1|Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805989|NCT00317772|OG001|Outcome|Phase 1 Dose Level 2|Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805990|NCT00317772|OG002|Outcome|Phase 1 Dose Level 3|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805991|NCT00317772|OG000|Outcome|All Phase 1 Participants|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805992|NCT00317772|OG003|Outcome|Expansion Phase|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805993|NCT00317772|EG000|Reported Event|Phase 1 Dose Level 1|Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805994|NCT00317772|EG001|Reported Event|Phase 1 Dose Level 2|Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805995|NCT00317772|EG002|Reported Event|Phase 1 Dose Level 3|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805996|NCT00317772|EG003|Reported Event|Expansion Phase|Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
10805997|NCT00291486|BG000|Baseline|Cohort 1|"20 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10805998|NCT00291486|BG001|Baseline|Cohort 2|"30 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150mg."
10805999|NCT00291486|BG002|Baseline|Cohort 3|"30 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806000|NCT00291486|BG003|Baseline|Cohort 4|"40 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806001|NCT00291486|BG004|Baseline|Cohort 5|"40 mCi 131I-huA33, 1250 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806002|NCT00291486|BG005|Baseline|Total|Total of all reporting groups
10806003|NCT00291486|FG000|Participant Flow|Cohort 1|"20 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806004|NCT00291486|FG001|Participant Flow|Cohort 2|"30 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806005|NCT00291486|FG002|Participant Flow|Cohort 3|"30 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806006|NCT00291486|FG003|Participant Flow|Cohort 4|"40 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10820621|NCT00060008|OG001|Outcome|SUVmax >2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
10806007|NCT00291486|FG004|Participant Flow|Cohort 5|"40 millicurie (mCi) 131I-huA33, 1250 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806008|NCT00291486|OG000|Outcome|Cohort 1|"20 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806009|NCT00291486|OG001|Outcome|Cohort 2|"30 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806010|NCT00291486|OG002|Outcome|Cohort 3|"30 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806011|NCT00291486|OG003|Outcome|Cohort 4|"40 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806012|NCT00291486|OG004|Outcome|Cohort 5|"40 mCi 131I-huA33, 1250 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806013|NCT00291486|OG000|Outcome|Cohorts 1-5|"All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806014|NCT00291486|OG000|Outcome|All Patients|"All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806015|NCT00291486|OG001|Outcome|Cohort 1; 20 mCi 131I-huA33|"20 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg"
10806016|NCT00291486|OG002|Outcome|Cohorts 2 and 3; 30 mCi 131I-huA33|"30 mCi 131I-huA33, 1500 mg/m2/day or 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10967044|NCT00891046|OG001|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
11244219|NCT02509117|OG002|Outcome|Part A: PF-06751979 40 mg|Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244220|NCT02509117|OG003|Outcome|Part A: PF-06751979 160 mg|Participants received 160 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10806017|NCT00291486|OG003|Outcome|Cohorts 4 and 5: 40 mCi 131I-huA33|"40 mCi 131I-huA33, 1000 mg/m2/day or 1250 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806018|NCT00291486|OG000|Outcome|Cohorts 1-5|"All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle. Daily doses were rounded to the nearest 150 mg."
10806019|NCT00291486|OG000|Outcome|Cohorts 1 and 2; 1500 mg/m2/Day Capecitabine|"20 or 30 mCi 131I-huA33, 1500 mg/m2/day capecitabine All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806020|NCT00291486|OG001|Outcome|Cohorts 3 and 4; 1000 mg/m2/Day Capecitabine|"30 or 40 mCi 131I-huA33, 1000 mg/m2/day capecitabine All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806021|NCT00291486|OG002|Outcome|Cohort 5; 1250 mg/m2/Day Capecitabine|"40 mCi 131I-huA33, 1250 mg/m2/day capecitabine All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg"
10806022|NCT00291486|EG000|Reported Event|Cohort 1|"20 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806023|NCT00291486|EG001|Reported Event|Cohort 2|"30 mCi 131I-huA33, 1500 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806024|NCT00291486|EG002|Reported Event|Cohort 3|"30 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806025|NCT00291486|EG003|Reported Event|Cohort 4|"40 mCi 131I-huA33, 1000 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806026|NCT00291486|EG004|Reported Event|Cohort 5|"40 mCi 131I-huA33, 1250 mg/m2/day capecitabine~All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.~This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).~Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg."
10806027|NCT00284856|BG000|Baseline|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806028|NCT00284856|BG001|Baseline|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
11244221|NCT02509117|OG000|Outcome|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244222|NCT02509117|OG001|Outcome|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806029|NCT00284856|BG002|Baseline|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806030|NCT00284856|BG003|Baseline|Total|Total of all reporting groups
10806031|NCT00284856|FG000|Participant Flow|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806032|NCT00284856|FG001|Participant Flow|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
10806033|NCT00284856|FG002|Participant Flow|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806034|NCT00284856|OG000|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806035|NCT00284856|OG001|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
10806036|NCT00284856|OG002|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806037|NCT00284856|EG000|Reported Event|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806038|NCT00284856|EG001|Reported Event|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
10806039|NCT00284856|EG002|Reported Event|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
10806040|NCT00070707|BG000|Baseline|Mometasone|Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
10806041|NCT00070707|BG001|Baseline|Placebo|Matching placebo nasal spray, administered QD for 4 weeks
10806042|NCT00070707|BG002|Baseline|Total|Total of all reporting groups
10806043|NCT00070707|FG000|Participant Flow|Mometasone|Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
10806044|NCT00070707|FG001|Participant Flow|Placebo|Matching placebo nasal spray, administered QD for 4 weeks
10806045|NCT00070707|OG000|Outcome|Mometasone|Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
10806046|NCT00070707|OG001|Outcome|Placebo|Matching placebo nasal spray, administered QD for 4 weeks
10806047|NCT00070707|EG000|Reported Event|Mometasone|Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
10806048|NCT00070707|EG001|Reported Event|Placebo|Matching placebo nasal spray, administered QD for 4 weeks
10820622|NCT00060008|EG000|Reported Event|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
10820623|NCT00060333|BG000|Baseline|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
10820624|NCT00060333|FG000|Participant Flow|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
10820625|NCT00060333|OG000|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
10820626|NCT00060333|OG000|Outcome|Treatment (Adjuvant Radiation Therapy) Q01|"Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 1 (Q01) of the Brief Fatigue Inventory (BFI) which instructs Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your fatigue right NOW."
10820627|NCT00060333|OG001|Outcome|Treatment (Adjuvant Radiation Therapy) Q02|"Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 2 (Q02) of the Brief Fatigue Inventory (BFI) which instructs Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your USUAL level of fatigue during the past 24 hours."
10820628|NCT00060333|OG002|Outcome|Treatment (Adjuvant Radiation Therapy) Q03|"Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 3 (Q03) of the Brief Fatigue Inventory (BFI) which instructs Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during the past 24 hours."
10820629|NCT00060333|EG000|Reported Event|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
11244223|NCT02509117|OG002|Outcome|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806049|NCT02358993|BG000|Baseline|Methenamine|"Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~methenamine hippurate: A urinary antiseptic used for prevention of UTI"
10806050|NCT02358993|BG001|Baseline|Ciprofloxacin|"Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~Ciprofloxacin: An antibiotic used for treatment and prevention of UTI"
10806051|NCT02358993|BG002|Baseline|Total|Total of all reporting groups
10806052|NCT02358993|FG000|Participant Flow|Methenamine|"Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~methenamine hippurate: A urinary antiseptic used for prevention of UTI"
10806053|NCT02358993|FG001|Participant Flow|Ciprofloxacin|"Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~Ciprofloxacin: An antibiotic used for treatment and prevention of UTI"
10806054|NCT02358993|OG000|Outcome|Methenamine|"Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~methenamine hippurate: A urinary antiseptic used for prevention of UTI"
10806055|NCT02358993|OG001|Outcome|Ciprofloxacin|"Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~Ciprofloxacin: An antibiotic used for treatment and prevention of UTI"
10806056|NCT02358993|EG000|Reported Event|Methenamine|"Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~methenamine hippurate: A urinary antiseptic used for prevention of UTI"
10806057|NCT02358993|EG001|Reported Event|Ciprofloxacin|"Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.~Ciprofloxacin: An antibiotic used for treatment and prevention of UTI"
10806058|NCT03566199|BG000|Baseline|Phase 1: Treatment (MTX110) - All Participants|"Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806059|NCT03566199|FG000|Participant Flow|Phase 1: Starting Dose Level 1 (MTX110)|"Participant received starting dose of single CED of 30 micrometer of MTX110 on 1 day (day 1); Total volume 3 mL. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806060|NCT03566199|FG001|Participant Flow|Phase 1: Starting Dose Level 2 (MTX110)|"Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 6 mL (3 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806061|NCT03566199|FG002|Participant Flow|Phase 1: Starting Dose Level 3 (MTX110)|"Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 8 mL (4 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806062|NCT03566199|FG003|Participant Flow|Phase 1: Starting Dose Level 4 (MTX110)|"Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 10 mL (5 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806063|NCT03566199|FG004|Participant Flow|Phase 1: Starting Dose Level 5 (MTX110)|"Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806064|NCT03566199|FG005|Participant Flow|Phase 1: Starting Dose Level 6 (MTX110)|"Participant received starting dose of repeated CED of 60 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806065|NCT03566199|FG006|Participant Flow|Phase 1: Starting Dose Level 7 (MTX110)|"Participant received starting dose of repeated CED of 90 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day).~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806066|NCT03566199|FG007|Participant Flow|Phase 2|"Participants will receive Recommended Phase 2 Dose (RP2D)~Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED"
10806067|NCT03566199|OG000|Outcome|Phase 1: Treatment (MTX110)|"Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Panobinostat Nanoparticle Formulation MTX110: Given IT~Convection-Enhanced Delivery (CED): Undergo CED"
10806068|NCT03566199|EG000|Reported Event|Phase 1: Treatment (MTX110)|"Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.~Panobinostat Nanoparticle Formulation MTX110: Given IT~Convection-Enhanced Delivery (CED): Undergo CED"
10820630|NCT00060346|BG000|Baseline|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
10820631|NCT00060346|FG000|Participant Flow|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
10820632|NCT00060346|OG000|Outcome|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
10820633|NCT00060346|EG000|Reported Event|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
10820634|NCT00060424|BG000|Baseline|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
10820635|NCT00060424|FG000|Participant Flow|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
10820636|NCT00060424|OG000|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
10820637|NCT00060424|EG000|Reported Event|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
10967045|NCT00891046|OG002|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10822119|NCT00074581|BG000|Baseline|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
10967046|NCT00891046|OG003|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to tocilizumab, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10806069|NCT04474197|BG000|Baseline|Placebo|Participants received placebo matched to VX-864 in the treatment period for 28 days.
10806070|NCT04474197|BG001|Baseline|VX-864 100 mg|Participants received VX-864 100 mg q12h in the treatment period for 28 days.
10806071|NCT04474197|BG002|Baseline|VX-864 300 mg|Participants received VX-864 300 mg q12h in the treatment period for 28 days.
10806072|NCT04474197|BG003|Baseline|VX-864 500 mg|Participants received VX-864 500 mg q12h in the treatment period for 28 days.
10806073|NCT04474197|BG004|Baseline|Total|Total of all reporting groups
10806074|NCT04474197|FG000|Participant Flow|Placebo|Participants received placebo matched to VX-864 in the treatment period for 28 days.
10806075|NCT04474197|FG001|Participant Flow|VX-864 100 mg|Participants received VX-864 100 milligrams (mg) every 12 hours (q12h) in the treatment period for 28 days.
10806076|NCT04474197|FG002|Participant Flow|VX-864 300 mg|Participants received VX-864 300 mg q12h in the treatment period for 28 days.
10806077|NCT04474197|FG003|Participant Flow|VX-864 500 mg|Participants received VX-864 500 mg q12h in the treatment period for 28 days.
10806078|NCT04474197|OG000|Outcome|Placebo|Participants received placebo matched to VX-864 in the treatment period for 28 days.
10806079|NCT04474197|OG001|Outcome|VX-864 100 mg|Participants received VX-864 100 mg q12h in the treatment period for 28 days.
10806080|NCT04474197|OG002|Outcome|VX-864 300 mg|Participants received VX-864 300 mg dose q12h in the treatment period for 28 days.
10806081|NCT04474197|OG003|Outcome|VX-864 500 mg|Participants received VX-864 500 mg dose q12h in the treatment period for 28 days.
10806082|NCT04474197|OG002|Outcome|VX-864 300 mg|Participants received VX-864 300 mg q12h in the treatment period for 28 days.
10806083|NCT04474197|OG003|Outcome|VX-864 500 mg|Participants received VX-864 500 mg q12h in the treatment period for 28 days.
10806084|NCT04474197|OG000|Outcome|VX-864 100 mg|Participants received VX-864 100 mg q12h in the treatment period for 28 days.
10806085|NCT04474197|OG001|Outcome|VX-864 300 mg|Participants received VX-864 300 mg q12h in the treatment period for 28 days.
10806086|NCT04474197|OG002|Outcome|VX-864 500 mg|Participants received VX-864 500 mg q12h in the treatment period for 28 days.
10806087|NCT04474197|EG000|Reported Event|Placebo|Participants received placebo matched to VX-864 in the treatment period for 28 days.
10806088|NCT04474197|EG001|Reported Event|VX-864 100 mg|Participants received VX-864 100 mg q12h in the treatment period for 28 days.
10806089|NCT04474197|EG002|Reported Event|VX-864 300 mg|Participants received VX-864 300 mg q12h in the treatment period for 28 days.
10806090|NCT04474197|EG003|Reported Event|VX-864 500 mg|Participants received VX-864 500 mg q12h in the treatment period for 28 days.
10806091|NCT04369950|BG000|Baseline|2 Percent Lidocaine With Epinephrine and Epidural Morphine|2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806092|NCT04369950|BG001|Baseline|3 Percent 2-Chloroprocaine and Epidural Morphine|3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806093|NCT04369950|BG002|Baseline|Total|Total of all reporting groups
10806094|NCT04369950|FG000|Participant Flow|2 Percent Lidocaine With Epinephrine and Epidural Morphine|2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806095|NCT04369950|FG001|Participant Flow|3 Percent 2-Chloroprocaine and Epidural Morphine|3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806096|NCT04369950|OG000|Outcome|2 Percent Lidocaine With Epinephrine and Epidural Morphine|2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10820638|NCT00060528|BG000|Baseline|Prostate Cancer Patients|Progressive Metastatic Castration Resistant Prostate Cancer
10820639|NCT00060528|FG000|Participant Flow|no GM|Vaccine subcutaneously with no GM
10820640|NCT00060528|FG001|Participant Flow|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
10820641|NCT00060528|FG002|Participant Flow|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
10806097|NCT04369950|OG001|Outcome|3 Percent 2-Chloroprocaine and Epidural Morphine|3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806098|NCT04369950|EG000|Reported Event|2 Percent Lidocaine With Epinephrine and Epidural Morphine|2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806099|NCT04369950|EG001|Reported Event|3 Percent 2-Chloroprocaine and Epidural Morphine|3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
10806100|NCT04070326|BG000|Baseline|Lanadelumab 150 mg: Age 2 to <6 Years|Participants aged 2 to <6 years received lanadelumab SC injection at a dose of 150 mg for q4wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806101|NCT04070326|BG001|Baseline|Lanadelumab 150 mg: Age 6 to <12 Years|Participants aged 6 to <12 years received lanadelumab SC injection at a dose of 150 mg for q2wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B). Participants could switch to a dosing regimen of 150 mg q4wks in Treatment Period B at the investigator's discretion and sponsor's medical monitor approval, if they were well controlled (e.g., attack free) for 26 weeks with lanadelumab treatment in this study.
10806102|NCT04070326|BG002|Baseline|Total|Total of all reporting groups
10806103|NCT04070326|FG000|Participant Flow|Lanadelumab 150 mg: Age 2 to <6 Years|Participants aged 2 to <6 years received lanadelumab SC injection at a dose of 150 mg for q4wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806104|NCT04070326|FG001|Participant Flow|Lanadelumab 150 mg: Age 6 to <12 Years|Participants aged 6 to <12 years received lanadelumab SC injection at a dose of 150 mg for q2wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B). Participants could switch to a dosing regimen of 150 mg q4wks in Treatment Period B at the investigator's discretion and sponsor's medical monitor approval, if they were well controlled (e.g., attack free) for 26 weeks with lanadelumab treatment in this study.
10806105|NCT04070326|OG000|Outcome|Lanadelumab 150 mg, q4wks|Participants received lanadelumab SC injection at a dose of 150 mg for q4wks with over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806106|NCT04070326|OG001|Outcome|Lanadelumab 150 mg, q2wks|Participants received lanadelumab SC injection at a dose of 150 mg for q2wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806107|NCT04070326|OG000|Outcome|Lanadelumab 150 mg: Age 2 to <6 Years|Participants aged 2 to <6 years received lanadelumab SC injection at a dose of 150 mg for q4wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806108|NCT04070326|OG001|Outcome|Lanadelumab 150 mg: Age 6 to <12 Years|Participants aged 6 to <12 years received lanadelumab SC injection at a dose of 150 mg for q2wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B). Participants could switch to a dosing regimen of 150 mg q4wks in Treatment Period B at the investigator's discretion and sponsor's medical monitor approval, if they were well controlled (e.g., attack free) for 26 weeks with lanadelumab treatment in this study.
10806109|NCT04070326|EG000|Reported Event|Lanadelumab 150 mg, q4wks|Participants received lanadelumab SC injection at a dose of 150 mg for q4wks with over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10806110|NCT04070326|EG001|Reported Event|Lanadelumab 150 mg, q2wks|Participants received lanadelumab SC injection at a dose of 150 mg for q2wks over 52-week Treatment Period (26-week Treatment Period A and 26-week Treatment Period B).
10820642|NCT00060528|FG003|Participant Flow|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
10820643|NCT00060528|OG000|Outcome|No GM|Vaccine subcutaneously with no GM
10820644|NCT00060528|OG001|Outcome|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
10820645|NCT00060528|OG002|Outcome|rF-GM (10^7pfu),|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
10820646|NCT00060528|OG003|Outcome|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
10820647|NCT00060528|OG000|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms:e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
10820648|NCT00060528|OG000|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
10820649|NCT00060528|OG000|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
10820650|NCT00060528|EG000|Reported Event|no GM|Vaccine subcutaneously with no GM
10820651|NCT00060528|EG001|Reported Event|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
10820652|NCT00060528|EG002|Reported Event|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
10820653|NCT00060528|EG003|Reported Event|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
10820654|NCT00060606|BG000|Baseline|Prenatal Surgery Group|Prenatal Myelomeningocele Repair Surgery: Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation.
11205010|NCT02224820|BG000|Baseline|Intravenous IdeS|"One or two doses of IdeS in ascending doses~IdeS"
10806111|NCT04003610|BG000|Baseline|Pemigatinib 13.5 mg|Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/deciliter [dL]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).
10806112|NCT04003610|BG001|Baseline|Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg|Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806113|NCT04003610|BG002|Baseline|Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg|Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806114|NCT04003610|BG003|Baseline|Total|Total of all reporting groups
10806115|NCT04003610|FG000|Participant Flow|Pemigatinib 13.5 mg|Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/deciliter [dL]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).
10806116|NCT04003610|FG001|Participant Flow|Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg|Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806117|NCT04003610|FG002|Participant Flow|Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg|Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806118|NCT04003610|OG000|Outcome|Pemigatinib 13.5 mg|Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/deciliter [dL]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).
10806119|NCT04003610|OG001|Outcome|Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg|Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806120|NCT04003610|OG002|Outcome|Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg|Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
11244224|NCT02509117|OG000|Outcome|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244225|NCT02509117|EG000|Reported Event|Part A: Placebo|Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10806121|NCT04003610|OG002|Outcome|Gemcitabine 1000 mg/m^2 Plus carboplatinGemcitabine 1000 mg/m^2 Plus Carboplatin|Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10820655|NCT00060606|BG001|Baseline|Postnatal Surgery Group|Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.
10806122|NCT04003610|EG000|Reported Event|Pemigatinib 13.5 mg|Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/deciliter [dL]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE).
10806123|NCT04003610|EG001|Reported Event|Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg|Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806124|NCT04003610|EG002|Reported Event|Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg|Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
10806125|NCT03920293|BG000|Baseline|Ravulizumab|"Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806126|NCT03920293|BG001|Baseline|Placebo|"Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806127|NCT03920293|BG002|Baseline|Total|Total of all reporting groups
10806128|NCT03920293|FG000|Participant Flow|Randomized-Controlled Period: Ravulizumab|Participants received a weight-based single loading dose (2400 to 3000 milligrams [mg]) of ravulizumab intravenously (IV) on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 once every 8 weeks (q8w), during the 26-week Randomized-Controlled Period of the study.
10806129|NCT03920293|FG001|Participant Flow|Randomized-Controlled Period: Placebo|Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.
10806130|NCT03920293|OG000|Outcome|Ravulizumab|"Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806131|NCT03920293|OG001|Outcome|Placebo|"Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806132|NCT03920293|EG000|Reported Event|Randomized-Controlled Period: Ravulizumab|"Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806133|NCT03920293|EG001|Reported Event|Randomized-Controlled Period: Placebo|"Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.~Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab."
10806134|NCT03907540|BG000|Baseline|All Subjects|All subjects who received a single dose [14C]-KD025 and oral belumosudil tablet
10806135|NCT03907540|FG000|Participant Flow|All Subjects (Part 1 and Part 2)|"Part 1: (Treatment A) KD025 200 mg tablet, fed (Day 1). then 1.75 hours later (Treatment B) [14C]-KD025 solution for infusion, 20 μg/mL (100 μg in 5 mL), containing not more than 37 kBq (1000 nCi) [14C], as a 15 min IV infusion, 100 μg, fed~Part 2: (Treatment C) Single [14C]-KD025 capsule 200 mg containing <= 9.8 megabecquerel 14C, fed"
10806136|NCT03907540|OG000|Outcome|Part 1: Treatment A|Belumosudil 200 mg Tablet
10806137|NCT03907540|OG001|Outcome|Part 1: Treatment B|[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV (20 μg per mL)
10806138|NCT03907540|OG001|Outcome|Part 1: Treatment B|[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV
10806139|NCT03907540|OG000|Outcome|Part 1 Treatment A|Belumosudil 200 mg Tablet 200 mg
10806140|NCT03907540|OG000|Outcome|Part 1: Treatment B|[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV
10806141|NCT03907540|OG000|Outcome|Part 1 Treatment A|Belumosudil 200 mg Tablet, 200 mg
10806142|NCT03907540|OG000|Outcome|Cumulative Urine Ae(%)|Percentage of [14C]-KD025 200 mg oral capsule excreted in urine
10806143|NCT03907540|OG001|Outcome|Cumulative Feces Ae (%)|Percentage of [14C]-KD025 200 mg oral capsule excreted in feces
10806144|NCT03907540|OG002|Outcome|Cumulative Total Ae (%)|Percentage of [14C]-KD025 200 mg oral capsule excreted overall
10806145|NCT03907540|OG000|Outcome|[14C]-KD025 Oral 200 mg KD025|[14C]-KD025 200 mg belumosudil oral capsule in the fed state
10806146|NCT03907540|EG000|Reported Event|All Subjects|All subjects completing Part 1 and Part 2
10806147|NCT03904108|BG000|Baseline|Ramucirumab|"Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles~Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)"
10806148|NCT03904108|FG000|Participant Flow|Ramucirumab|"Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles~Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)"
10806149|NCT03904108|OG000|Outcome|Ramucirumab|"Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles~Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)"
10806150|NCT03904108|EG000|Reported Event|Ramucirumab|"Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles~Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)"
10806151|NCT03712345|BG000|Baseline|IFX-1 Low Dose|"Will receive IFX-1 low dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806152|NCT03712345|BG001|Baseline|IFX-1 High Dose|"Will receive IFX-1 high dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806153|NCT03712345|BG002|Baseline|Placebo|"Will receive placebo~Placebo: Placebo"
10806154|NCT03712345|BG003|Baseline|Total|Total of all reporting groups
11244226|NCT02509117|EG001|Reported Event|Part A: PF-06751979 3 mg|Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10806155|NCT03712345|FG000|Participant Flow|IFX-1 High Dose|"Will receive IFX-1 high dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806156|NCT03712345|FG001|Participant Flow|IFX-1 Low Dose|"Will receive IFX-1 low dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806157|NCT03712345|FG002|Participant Flow|Placebo|"Will receive placebo~Placebo: Placebo"
10806158|NCT03712345|OG000|Outcome|IFX-1 High Dose|"Will receive IFX-1 high dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806159|NCT03712345|OG001|Outcome|IFX-1 Low Dose|"Will receive IFX-1 low dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806160|NCT03712345|OG002|Outcome|Placebo|"Will receive placebo~Placebo: Placebo"
11244227|NCT02509117|EG002|Reported Event|Part A: PF-06751979 12 mg|Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
11244228|NCT02509117|EG003|Reported Event|Part A: PF-06751979 40 mg|Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10806161|NCT03712345|EG000|Reported Event|IFX-1 High Dose|"Will receive IFX-1 high dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806162|NCT03712345|EG001|Reported Event|IFX-1 Low Dose|"Will receive IFX-1 low dose regimen diluted in sodium chloride solution~IFX-1: Single IV infusions of IFX-1"
10806163|NCT03712345|EG002|Reported Event|Placebo|"Will receive placebo~Placebo: Placebo"
10806164|NCT03694275|BG000|Baseline|Soticlestat Dup15q|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with Dup15q weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806165|NCT03694275|BG001|Baseline|Soticlestat CDD|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806166|NCT03694275|BG002|Baseline|Total|Total of all reporting groups
10806167|NCT03694275|FG000|Participant Flow|Soticlestat Dup15q|Soticlestat tablets twice daily (BID) orally or via gastrostomy tube (G-tube)/ percutaneous endoscopic gastrostomy (PEG) tube, BID. Participants with Dup15q weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806168|NCT03694275|FG001|Participant Flow|Soticlestat CDD|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806169|NCT03694275|OG000|Outcome|Soticlestat Dup15q|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with Dup15q weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806170|NCT03694275|OG001|Outcome|Soticlestat CDD|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806171|NCT03694275|OG000|Outcome|Soticlestat CDD|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806172|NCT03694275|EG000|Reported Event|Soticlestat Dup15q|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with Dup15q weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
10806173|NCT03694275|EG001|Reported Event|Soticlestat CDD|Soticlestat tablets BID orally or via G-tube/ PEG tube, BID. Participants with CDD weighing <60 kg at Baseline received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
11244229|NCT02509117|EG004|Reported Event|Part A: PF-06751979 160 mg|Participants received 160 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period.
10806174|NCT03391232|BG000|Baseline|Single Dose of PolyPEPI1018 CRC Vaccine|The subjects were treated with only one dose PolyPEPI1018 CRC vaccine.
10806175|NCT03391232|BG001|Baseline|Multiple Dose of PolyPEPI1018 CRC Vaccine|The subjects received 2 or 3 doses PolyPEPI1018 CRC vaccine.
10806176|NCT03391232|BG002|Baseline|Total|Total of all reporting groups
10806177|NCT03391232|FG000|Participant Flow|Single Dose - PolyPEPI1018 CRC Vaccine|"The subjects in this group received only one dose of PolyPEPI1018 CRC vaccine and they finished the trial after 12 weeks follow up.~The PolyPEPI1018 CRC vaccine contains 6 synthetic peptides derived from 7 tumor specific antigens (AG), mixed with the adjuvant Montanide™."
10806178|NCT03391232|FG001|Participant Flow|Multiple Doses - PolyPEPI1018 CRC Vaccine|The subjects received 3 doses of the PolyPEPI1018 CRC vaccine Q12W. The PolyPEPI1018 CRC vaccine contains 6 synthetic peptides derived from 7 tumor specific antigens (AG), mixed with the adjuvant Montanide™.
10806179|NCT03391232|OG000|Outcome|Single Dose of PolyPEPI1018 CRC Vaccine|The subjects were treated with only one dose PolyPEPI1018 CRC vaccine.
10806180|NCT03391232|OG001|Outcome|Multiple Dose of PolyPEPI1018 CRC Vaccine|The subjects received 2 or 3 doses PolyPEPI1018 CRC vaccine.
10806181|NCT03391232|OG000|Outcome|Single Dose of PolyPEPI1018 CRC Vaccine|by sample quality only 2 of 5 single dosed patients were tested for PolyPEPI1018 induced recruitment of TILs (CD3+ and CD8+ T cells) to the invasive margin and core tumor area
10806182|NCT03391232|OG001|Outcome|Multiple Dose of PolyPEPI1018 CRC Vaccine|by sample quality only 2 of 6 multiple dosed patients were tested for PolyPEPI1018 induced recruitment of TILs (CD3+ and CD8+ T cells) to the invasive margin and core tumor area
10806183|NCT03391232|EG000|Reported Event|Single Dose of PolyPEPI1018 CRC Vaccine|The subjects were treated with only one dose PolyPEPI1018 CRC vaccine.
10806184|NCT03391232|EG001|Reported Event|Multiple Dose of PolyPEPI1018 CRC Vaccine|The subjects received 2 or 3 doses PolyPEPI1018 CRC vaccine.
10806185|NCT03323736|BG000|Baseline|Pivotal Cohort|"Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement."
10806186|NCT03323736|BG001|Baseline|Office Lead-In Cohort|"Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator).~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement."
10806187|NCT03323736|BG002|Baseline|OR Lead-In Cohort|"Tubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator).~Tube placement: Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement."
10806188|NCT03323736|BG003|Baseline|Total|Total of all reporting groups
10806189|NCT03323736|FG000|Participant Flow|Pivotal Cohort|Active Tymbion iontophoresis and tube insertion in all ears indicated for tube placement using the Tube Delivery System (TDS) in office.
10806190|NCT03323736|FG001|Participant Flow|Office Lead-In Cohort|Active Tymbion iontophoresis and tube insertion in all indicated ears using the Tube Delivery System in-office. Physician initial iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator).
10806191|NCT03323736|FG002|Participant Flow|OR Lead-In Cohort|Tube insertion using the Tube Delivery System (TDS) in all indicated ears in the operating room (OR). Physician initial tube insertion procedures using the TDS in the OR (minimum of 2 subjects per investigator).
10806192|NCT03323736|OG000|Outcome|Pivotal Cohort (6 Month to <5 Year Old Children)|"Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the tube delivery system in all ears indicated for tube placement."
10806193|NCT03323736|OG001|Outcome|Pivotal Cohort (5 Through 12 Year Old Children)|"Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the tube delivery system in all ears indicated for tube placement."
10806194|NCT03323736|OG000|Outcome|Pivotal Cohort (5 Through 12 Year Olds)|"Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the tube delivery system in all ears indicated for tube placement."
10806195|NCT03323736|OG000|Outcome|Pivotal Cohort|"Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement."
10806196|NCT03323736|OG000|Outcome|Pivotal Cohort|"Active Tymbion iontophoresis and tubes insertion using the Tube Delivery System in-office~Iontophoresis & tube placement: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the tube delivery system in all ears indicated for tube placement."
10806197|NCT03323736|EG000|Reported Event|OR Lead-In Cohort (Subjects Treated in OR)|Tube insertion using the Tube Delivery System (TDS) in all indicated ears in the operating room (OR). Physician initial tube insertion procedures using the TDS in the OR (minimum of 2 subjects per investigator).
10806198|NCT03323736|EG001|Reported Event|Office Lead-In Cohort (Subjects Treated in Office)|Active Tymbion iontophoresis and tube insertion in all ears indicated for tube placement using the Tube Delivery System (TDS) in office. Physician initial tube insertion procedures using the Iontophoresis System and the TDS in the Office (minimum of 2 subjects per investigator).
10806199|NCT03323736|EG002|Reported Event|Pivotal Cohort (Subjects Treated in Office)|Active Tymbion iontophoresis and tube insertion in all ears indicated for tube placement using the Tube Delivery System (TDS) in office.
10806200|NCT03179995|BG000|Baseline|Octreotide Treatment Arm|"Octreotide will be administered post-operatively until day 5~Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption."
10820656|NCT00060606|BG002|Baseline|Total|Total of all reporting groups
10806201|NCT03179995|BG001|Baseline|Placebo Arm|"Normal saline will be administered post-operatively until day 5~Placebo: Normal saline will be administered in the same fashion as Octreotide"
10806202|NCT03179995|BG002|Baseline|Total|Total of all reporting groups
10806203|NCT03179995|FG000|Participant Flow|Octreotide Treatment Arm|"Octreotide will be administered post-operatively until day 5~Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption."
10806204|NCT03179995|FG001|Participant Flow|Placebo Arm|"Normal saline will be administered post-operatively until day 5~Placebo: Normal saline will be administered in the same fashion as Octreotide"
10806205|NCT03179995|OG000|Outcome|Octreotide Treatment Arm|"Octreotide will be administered post-operatively until day 5~Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption."
10806206|NCT03179995|OG001|Outcome|Placebo Arm|"Normal saline will be administered post-operatively until day 5~Placebo: Normal saline will be administered in the same fashion as Octreotide"
10806207|NCT03179995|EG000|Reported Event|Octreotide Treatment Arm|"Octreotide will be administered post-operatively until day 5~Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption."
10806208|NCT03179995|EG001|Reported Event|Placebo Arm|"Normal saline will be administered post-operatively until day 5~Placebo: Normal saline will be administered in the same fashion as Octreotide"
10806209|NCT03073980|BG000|Baseline|Group A: IV Acetaminophen/PO Placebo|"In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.~IV Acetaminophen: IV Acetaminophen for pain control during procedure~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806210|NCT03073980|BG001|Baseline|Group B: IV Placebo/PO Acetaminophen|"In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.~PO Acetaminophen: PO Acetaminophen for pain control during procedure~Placebo IV Acetaminophen: Placebo IV Acetaminophen"
10806211|NCT03073980|BG002|Baseline|Group C: IV Placebo / PO Placebo|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806212|NCT03073980|BG003|Baseline|Total|Total of all reporting groups
10806213|NCT03073980|FG000|Participant Flow|Group A: IV Acetaminophen/PO Placebo|"In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.~IV Acetaminophen: IV Acetaminophen for pain control during procedure~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806214|NCT03073980|FG001|Participant Flow|Group B: IV Placebo/PO Acetaminophen|"In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.~PO Acetaminophen: PO Acetaminophen for pain control during procedure~Placebo IV Acetaminophen: Placebo IV Acetaminophen"
10806215|NCT03073980|FG002|Participant Flow|Group C: IV Placebo/ PO Placebo|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806216|NCT03073980|OG000|Outcome|Group 1: IV Acetaminophen/PO Placebo|"In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.~IV Acetaminophen: IV Acetaminophen for pain control during procedure~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806217|NCT03073980|OG001|Outcome|Group 2: IV Placebo/PO Acetaminophen|"In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.~PO Acetaminophen: PO Acetaminophen for pain control during procedure~Placebo IV Acetaminophen: Placebo IV Acetaminophen"
10806218|NCT03073980|OG002|Outcome|Group 3: IV Placebo/PO Placebo|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806219|NCT03073980|OG002|Outcome|Group 3: Placebo / Standard of Care|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806220|NCT03073980|OG000|Outcome|Group A: IV Acetaminophen/PO Placebo|"In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.~IV Acetaminophen: IV Acetaminophen for pain control during procedure~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806221|NCT03073980|OG001|Outcome|Group B: IV Placebo/PO Acetaminophen|"In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.~PO Acetaminophen: PO Acetaminophen for pain control during procedure~Placebo IV Acetaminophen: Placebo IV Acetaminophen"
10806222|NCT03073980|OG002|Outcome|Group C: IV Placebo/ PO Placebo|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806223|NCT03073980|EG000|Reported Event|Group A: IV Acetaminophen/PO Placebo|"In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.~IV Acetaminophen: IV Acetaminophen for pain control during procedure~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806224|NCT03073980|EG001|Reported Event|Group B: IV Placebo/PO Acetaminophen|"In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.~PO Acetaminophen: PO Acetaminophen for pain control during procedure~Placebo IV Acetaminophen: Placebo IV Acetaminophen"
11205011|NCT02224820|FG000|Participant Flow|Intravenous IdeS|One or two doses of IdeS in ascending doses.
11205012|NCT02224820|OG000|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
11205013|NCT02224820|EG000|Reported Event|Intravenous IdeS|One or two doses of IdeS in ascending doses.
10806225|NCT03073980|EG002|Reported Event|Group C: IV Placebo/ PO Placebo|"In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.~Placebo IV Acetaminophen: Placebo IV Acetaminophen~Placebo PO Acetaminophen: Placebo PO Acetaminophen"
10806226|NCT02879318|BG000|Baseline|Gemcitabine Plus Nab-Paclitaxel|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.~Gemcitabine~Nab-paclitaxel"
10806227|NCT02879318|BG001|Baseline|Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.~plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.~Gemcitabine~Nab-paclitaxel~Durvalumab~Tremelimumab"
10806228|NCT02879318|BG002|Baseline|Total|Total of all reporting groups
10806229|NCT02879318|FG000|Participant Flow|Gemcitabine Plus Nab-Paclitaxel|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.~Gemcitabine~Nab-paclitaxel"
10806230|NCT02879318|FG001|Participant Flow|Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.~plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.~Gemcitabine~Nab-paclitaxel~Durvalumab~Tremelimumab"
10806231|NCT02879318|OG000|Outcome|Gemcitabine Plus Nab-Paclitaxel|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.~Gemcitabine~Nab-paclitaxel"
10806232|NCT02879318|OG001|Outcome|Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.~plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.~Gemcitabine~Nab-paclitaxel~Durvalumab~Tremelimumab"
10806233|NCT02879318|EG000|Reported Event|Gemcitabine Plus Nab-Paclitaxel|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.~Gemcitabine~Nab-paclitaxel"
10806234|NCT02879318|EG001|Reported Event|Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab|"Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.~plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.~Gemcitabine~Nab-paclitaxel~Durvalumab~Tremelimumab"
10806235|NCT02544074|BG000|Baseline|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806236|NCT02544074|BG001|Baseline|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806237|NCT02544074|BG002|Baseline|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806238|NCT02544074|BG003|Baseline|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806239|NCT02544074|BG004|Baseline|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806240|NCT02544074|BG005|Baseline|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806241|NCT02544074|BG006|Baseline|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806242|NCT02544074|BG007|Baseline|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806243|NCT02544074|BG008|Baseline|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806244|NCT02544074|BG009|Baseline|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806245|NCT02544074|BG010|Baseline|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806246|NCT02544074|BG011|Baseline|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806247|NCT02544074|BG012|Baseline|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806248|NCT02544074|BG013|Baseline|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806249|NCT02544074|BG014|Baseline|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806250|NCT02544074|BG015|Baseline|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
11205014|NCT02224846|BG000|Baseline|2.5 mg/5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
10806251|NCT02544074|BG016|Baseline|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806252|NCT02544074|BG017|Baseline|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806253|NCT02544074|BG018|Baseline|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806254|NCT02544074|BG019|Baseline|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806255|NCT02544074|BG020|Baseline|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806256|NCT02544074|BG021|Baseline|Total|Total of all reporting groups
10806257|NCT02544074|FG000|Participant Flow|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806258|NCT02544074|FG001|Participant Flow|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806259|NCT02544074|FG002|Participant Flow|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806260|NCT02544074|FG003|Participant Flow|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806261|NCT02544074|FG004|Participant Flow|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806262|NCT02544074|FG005|Participant Flow|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806263|NCT02544074|FG006|Participant Flow|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806264|NCT02544074|FG007|Participant Flow|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806265|NCT02544074|FG008|Participant Flow|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806266|NCT02544074|FG009|Participant Flow|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806267|NCT02544074|FG010|Participant Flow|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806268|NCT02544074|FG011|Participant Flow|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806269|NCT02544074|FG012|Participant Flow|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806270|NCT02544074|FG013|Participant Flow|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806271|NCT02544074|FG014|Participant Flow|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806272|NCT02544074|FG015|Participant Flow|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806273|NCT02544074|FG016|Participant Flow|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806274|NCT02544074|FG017|Participant Flow|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806275|NCT02544074|FG018|Participant Flow|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806276|NCT02544074|FG019|Participant Flow|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806277|NCT02544074|FG020|Participant Flow|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10820657|NCT00060606|FG000|Participant Flow|Prenatal Surgery Group|"Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.~Prenatal Myelomeningocele Repair Surgery: Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation."
10806278|NCT02544074|OG000|Outcome|eSAGE Score Compared to the Sum of Neuropsychological Measures|"Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include:~Boston Naming Test~Wisconsin Card Sort Task (WCST)~Hopkins Verbal Learning Test (HVLT)~FAS verbal fluency task~Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests~Associations will be investigated using Spearman correlations."
10806279|NCT02544074|OG000|Outcome|eSAGE Score Compared to the Paper SAGE Score|The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.
10806280|NCT02544074|OG000|Outcome|eSAGE Score Compared to the Mini-Mental State Exam Score|The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.
10806281|NCT02544074|OG000|Outcome|eSAGE Score Compared to the MoCA Score|The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.
10806282|NCT02544074|OG000|Outcome|eSAGE Score Compared to the Boston Naming Test Score|The investigators will compare the eSAGE scores to the Boston Naming Test scores. Associations will be investigated using Spearman correlations.
10806283|NCT02544074|OG000|Outcome|eSAGE Score Compared to the WCST Score|The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.
10806284|NCT02544074|OG000|Outcome|eSAGE Score Compared to the HVLT Total Learning Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations.
10806285|NCT02544074|OG001|Outcome|eSAGE Score Compared to the HVLT Delayed Recall Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.
10806286|NCT02544074|OG000|Outcome|eSAGE Score Compared to the FAS Verbal Fluency Task Score|The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.
10806287|NCT02544074|OG000|Outcome|eSAGE Score Compared to the WAIS III Letter-number Score|The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. Associations will be investigated using Spearman correlations.
10806288|NCT02544074|OG000|Outcome|eSAGE Score Compared to the WAIS III Block Design Score|The investigators will compare the eSAGE scores to the WAIS III Block Design scores. Associations will be investigated using Spearman correlations.
10806289|NCT02544074|EG000|Reported Event|eSAGE Score of 2|"Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806290|NCT02544074|EG001|Reported Event|eSAGE Score of 3|"Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806291|NCT02544074|EG002|Reported Event|eSAGE Score of 4|"Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806292|NCT02544074|EG003|Reported Event|eSAGE Score of 5|"Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806293|NCT02544074|EG004|Reported Event|eSAGE Score of 6|"Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806294|NCT02544074|EG005|Reported Event|eSAGE Score of 7|"Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806295|NCT02544074|EG006|Reported Event|eSAGE Score of 8|"Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806296|NCT02544074|EG007|Reported Event|eSAGE Score of 9|"Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806297|NCT02544074|EG008|Reported Event|eSAGE Score of 10|"Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806298|NCT02544074|EG009|Reported Event|eSAGE Score of 11|"Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806299|NCT02544074|EG010|Reported Event|eSAGE Score of 12|"Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806300|NCT02544074|EG011|Reported Event|eSAGE Score of 13|"Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806301|NCT02544074|EG012|Reported Event|eSAGE Score of 14|"Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806302|NCT02544074|EG013|Reported Event|eSAGE Score of 15|"Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806303|NCT02544074|EG014|Reported Event|eSAGE Score of 16|"Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
11244230|NCT02509117|EG005|Reported Event|Part B: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806304|NCT02544074|EG015|Reported Event|eSAGE Score of 17|"Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806305|NCT02544074|EG016|Reported Event|eSAGE Score of 18|"Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806306|NCT02544074|EG017|Reported Event|eSAGE Score of 19|"Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806307|NCT02544074|EG018|Reported Event|eSAGE Score of 20|"Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806308|NCT02544074|EG019|Reported Event|eSAGE Score of 21|"Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806309|NCT02544074|EG020|Reported Event|eSAGE Score of 22|"Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.~neuropsychological testing: standard neuropsychological testing including brief standardized assessments"
10806310|NCT02367040|BG000|Baseline|Copanlisib + Rituximab|Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
10806311|NCT02367040|BG001|Baseline|Placebo + Rituximab|Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
10806312|NCT02367040|BG002|Baseline|Total|Total of all reporting groups
10806313|NCT02367040|FG000|Participant Flow|Copanlisib + Rituximab|Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
10806314|NCT02367040|FG001|Participant Flow|Placebo + Rituximab|Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
10806315|NCT02367040|OG000|Outcome|Copanlisib + Rituximab|Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
10806316|NCT02367040|OG001|Outcome|Placebo + Rituximab|Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
10806317|NCT02367040|EG000|Reported Event|Copanlisib + Rituximab|Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab.
10806318|NCT02367040|EG001|Reported Event|Placebo + Rituximab|Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab.
10806319|NCT02317627|BG000|Baseline|400 mg QD|Belumosudil 400 mg PO QD for 12 weeks
10806320|NCT02317627|BG001|Baseline|200 mg BID|Belumosudil 200 mg PO BID for 12 weeks
10806321|NCT02317627|BG002|Baseline|400 mg BID|Belumosudil 400 mg PO BID for 12 weeks
10806322|NCT02317627|BG003|Baseline|Total|Total of all reporting groups
10806323|NCT02317627|FG000|Participant Flow|400 mg QD|Belumosudil 400 mg administered orally (PO) once daily (QD) for 12 weeks
10806324|NCT02317627|FG001|Participant Flow|200 mg BID|Belumosudil 200 mg administered PO twice daily (BID) for 12 weeks
10806325|NCT02317627|FG002|Participant Flow|400 mg BID|Belumosudil 400 mg administered PO BID for 12 weeks
10806326|NCT02317627|OG000|Outcome|400 mg QD|Belumosudil 400 mg PO QD for 12 weeks
10806327|NCT02317627|OG001|Outcome|200 mg BID|Belumosudil 200 mg PO BID for 12 weeks
10806328|NCT02317627|OG002|Outcome|400 mg BID|Belumosudil 400 mg PO BID for 12 weeks
10806329|NCT02317627|OG003|Outcome|Overall (All Subjects)|Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
10806330|NCT02317627|OG000|Outcome|400 mg QD|Belumosudl 400 mg PO QD for 12 weeks
10806331|NCT02317627|OG003|Outcome|Overall (All Subjects)|Belumosudil 400 mg PO QD + 200 mg PO QD + 400 mg PO BID for 12 weeks
10806332|NCT02317627|OG000|Outcome|400 mg QD|Belumosudil 400 mg administered QD (once daily)
10806333|NCT02317627|OG001|Outcome|200 mg BID|Belumosudil 200 mg administered PO BID (twice daily)
10806334|NCT02317627|EG000|Reported Event|400 mg QD|Belumosudil 400 mg PO QD for 12 weeks
10806335|NCT02317627|EG001|Reported Event|200 mg BID|Belumosudil 200 mg PO BID for 12 weeks
10806336|NCT02317627|EG002|Reported Event|400 mg BID|Belumosudil 400 mg PO BID for 12 weeks
10806337|NCT02317627|EG003|Reported Event|Overall (All Subjects)|Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
11205015|NCT02224846|BG001|Baseline|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
11205016|NCT02224846|BG002|Baseline|Total|Total of all reporting groups
11205017|NCT02224846|FG000|Participant Flow|2.5 mg/5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
11205018|NCT02224846|FG001|Participant Flow|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
11205019|NCT02224846|OG000|Outcome|2.5 mg/5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
10806338|NCT01935128|BG000|Baseline|Arm 1 Everolimus/Reduced Dose Tacrolimus|"In this arm, the myfortic® will be weaned off quickly and everolimus (Zortress®) initiated to achieve a target level of 3-8 ng/ml with a mean of 6 ng/ml. Once achieving a therapeutic dose of everolimus (Zortress®) the tacrolimus (Prograf® or Hecoria®) dose will be reduced a target level of 3-5 ng/ml.~Arm 1 Everolimus/Reduced dose tacrolimus: Immunosuppression drug intervention"
10806339|NCT01935128|FG000|Participant Flow|Arm 1 Everolimus/Reduced Dose Tacrolimus|"In this arm, the myfortic® will be weaned off quickly and everolimus (Zortress®) initiated to achieve a target level of 3-8 ng/ml with a mean of 6 ng/ml. Once achieving a therapeutic dose of everolimus (Zortress®) the tacrolimus (Prograf® or Hecoria®) dose will be reduced a target level of 3-5 ng/ml.~Arm 1 Everolimus/Reduced dose tacrolimus: Immunosuppression drug intervention"
10806340|NCT01935128|OG000|Outcome|Arm 1 Everolimus/Reduced Dose Tacrolimus|"In this arm, the myfortic® will be weaned off quickly and everolimus (Zortress®) initiated to achieve a target level of 3-8 ng/ml with a mean of 6 ng/ml. Once achieving a therapeutic dose of everolimus (Zortress®) the tacrolimus (Prograf® or Hecoria®) dose will be reduced a target level of 3-5 ng/ml.~Arm 1 Everolimus/Reduced dose tacrolimus: Immunosuppression drug intervention"
10806341|NCT01935128|EG000|Reported Event|Arm 1 Everolimus/Reduced Dose Tacrolimus|"In this arm, the myfortic® will be weaned off quickly and everolimus (Zortress®) initiated to achieve a target level of 3-8 ng/ml with a mean of 6 ng/ml. Once achieving a therapeutic dose of everolimus (Zortress®) the tacrolimus (Prograf® or Hecoria®) dose will be reduced a target level of 3-5 ng/ml.~Arm 1 Everolimus/Reduced dose tacrolimus: Immunosuppression drug intervention"
11205020|NCT02224846|OG001|Outcome|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
11205021|NCT02224846|EG000|Reported Event|2.5 mg/5 mg Tadalafil|2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
11205022|NCT02224846|EG001|Reported Event|5 mg Tadalafil|5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
11205023|NCT02225080|BG000|Baseline|Duragen Secure|Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
11205024|NCT02225080|FG000|Participant Flow|Duragen Secure|Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
11205025|NCT02225080|OG000|Outcome|Duragen Secure|Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
11205026|NCT02225080|EG000|Reported Event|Duragen Secure|Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
11205027|NCT02225106|BG000|Baseline|Open Label Methylphenidate Treatment|"Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.~Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated."
11205028|NCT02225106|FG000|Participant Flow|Open Label Methylphenidate Treatment|"Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.~Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated."
11205029|NCT02225106|OG000|Outcome|Open Label Methylphenidate Treatment|"Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.~Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated."
11205030|NCT02225106|EG000|Reported Event|Open Label Methylphenidate Treatment|"Forced titration with methylphenidate up to a dose of 30 mg administered orally twice daily.~Methylphenidate: Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated."
11205031|NCT02225132|BG000|Baseline|Hydroxyurea|Hydroxyurea is given to the patients as per a dosing algorithm.
11205032|NCT02225132|FG000|Participant Flow|Hydroxyurea|Hydroxyurea is given to the patients as per a dosing algorithm.
11205033|NCT02225132|OG000|Outcome|Hydroxyurea|Hydroxyurea is given to the patients as per a dosing algorithm.
11205034|NCT02225132|EG000|Reported Event|Hydroxyurea|Hydroxyurea is given to the patients as per a dosing algorithm.
11205035|NCT02225223|BG000|Baseline|No Previous Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
11244231|NCT02509117|EG006|Reported Event|Part B- PF-06751979 5 mg|Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244232|NCT02509117|EG007|Reported Event|Part B- PF-06751979 15 mg|Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806466|NCT01909934|BG000|Baseline|Brentuximab Vedotin 1.8 mg/kg|Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
10806467|NCT01909934|FG000|Participant Flow|Brentuximab Vedotin 1.8 mg/kg|Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
10806468|NCT01909934|OG000|Outcome|Brentuximab Vedotin 1.8 mg/kg|Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
10806469|NCT01909934|EG000|Reported Event|Brentuximab Vedotin 1.8 mg/kg|Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
10806470|NCT01841359|BG000|Baseline|Pramlintide (Symlin)|"Participants in this study completed 4 study visits. Study visit 1 was a screening visit. Participants kept a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test were performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom log was reviewed. Pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times.~Study visit 3 occurred at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat mixed meal tolerance test.~Pramlintide: See description above (arm description)."
10806471|NCT01841359|FG000|Participant Flow|Pramlintide (Symlin)|"Participants in this study were asked to complete 4 study visits. Study visit 1 was a screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom log was reviewed. Pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times.~Study visit 3 occured at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat mixed meal tolerance test.~Pramlintide: See description above (arm description)."
10806472|NCT01841359|OG000|Outcome|Baseline (Prior to Pramlintide Treatment) Mixed Meal #1|Mixed meal #1 performed prior to initiation of pramlintide treatment.
10806473|NCT01841359|OG001|Outcome|Pramlintide - Mixed Meal #2|Mixed meal #2 performed after 1 dose of pramlintide given 15 minutes prior to the mixed meal, at maximum tolerated dose achieved during the outpatient stage.
10806474|NCT01841359|OG000|Outcome|Baseline (Prior to Treatment With Pramlintide) CGM #1|Stage 1 of sequential design. Participant CGM data at baseline, prior to initiation of treatment with pramlintide TID.
10806475|NCT01841359|OG001|Outcome|Pramlintide CGM #2|Stage 2 of sequential design. Participant CGM data during treatment with pramlintide TID.
10806476|NCT01841359|EG000|Reported Event|Pramlintide (Symlin)|"Participants in this study were asked to complete 4 study visits. Study visit 1 was a screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom log was reviewed. Pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times.~Study visit 3 occured at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat mixed meal tolerance test.~Pramlintide: See description above (arm description)."
10806477|NCT01459666|BG000|Baseline|Dysport (abobotulinumtoxinA)|"Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.~Dysport (abobotulinumtoxinA): Intramuscular injection effects lasting up to 3 months"
10806478|NCT01459666|BG001|Baseline|Placebo|Bacteriostatic 0.9% Sodium Chloride (vehicle): Intramuscular injection
11244233|NCT02509117|EG008|Reported Event|Part B: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806479|NCT01459666|BG002|Baseline|Total|Total of all reporting groups
10806480|NCT01459666|FG000|Participant Flow|Dysport (abobotulinumtoxinA)|"Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.~Dysport (abobotulinumtoxinA): Intramuscular injection effects lasting up to 3 months"
10806481|NCT01459666|FG001|Participant Flow|Placebo|Bacteriostatic 0.9% Sodium Chloride (vehicle): Intramuscular injection
10806482|NCT01459666|OG000|Outcome|Dysport (abobotulinumtoxinA)|"Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.~Dysport (abobotulinumtoxinA): Intramuscular injection effects lasting up to 3 months"
10806483|NCT01459666|OG001|Outcome|Placebo|Bacteriostatic 0.9% Sodium Chloride (vehicle): Intramuscular injection
10806484|NCT01459666|EG000|Reported Event|Dysport (abobotulinumtoxinA)|"Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.~Dysport (abobotulinumtoxinA): Intramuscular injection effects lasting up to 3 months"
10806485|NCT01459666|EG001|Reported Event|Placebo|Bacteriostatic 0.9% Sodium Chloride (vehicle): Intramuscular injection
10806486|NCT01369199|BG000|Baseline|Peginterferon and Entecavir|Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
10806487|NCT01369199|FG000|Participant Flow|Peginterferon and Entecavir|Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up for 48 weeks.
10806488|NCT01369199|OG000|Outcome|Peginterferon and Entecavir|Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
10806489|NCT01369199|EG000|Reported Event|Peginterferon and Entecavir|Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously (sq) weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment will be for 48 weeks.
10806490|NCT01368497|BG000|Baseline|Entecavir and Peginterferon|Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
10806491|NCT01368497|FG000|Participant Flow|Entecavir and Peginterferon|Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
11244234|NCT02509117|EG009|Reported Event|Part C: Placebo|Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
10806492|NCT01368497|OG000|Outcome|Entecavir and Peginterferon|Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
10806493|NCT01368497|EG000|Reported Event|Entecavir and Peginterferon|Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
11244235|NCT02509117|EG010|Reported Event|Part C: PF-06751979 50 mg|Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29.
11244236|NCT02509156|BG000|Baseline|Allo-MSCs|"Target dose of 100 million allo-MSCs~Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
10806511|NCT00977574|BG000|Baseline|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806512|NCT00977574|BG001|Baseline|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
10806513|NCT00977574|BG002|Baseline|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806514|NCT00977574|BG003|Baseline|Total|Total of all reporting groups
10806515|NCT00977574|FG000|Participant Flow|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806516|NCT00977574|FG001|Participant Flow|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
10806517|NCT00977574|FG002|Participant Flow|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806518|NCT00977574|OG000|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806519|NCT00977574|OG001|Outcome|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
10806520|NCT00977574|OG002|Outcome|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806521|NCT00977574|EG000|Reported Event|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10806522|NCT00977574|EG001|Reported Event|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
10806523|NCT00977574|EG002|Reported Event|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
10820658|NCT00060606|FG001|Participant Flow|Postnatal Surgery Group|"Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.~Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect"
10820659|NCT00060606|OG000|Outcome|Prenatal Surgery|"Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.~Prenatal Myelomeningocele Repair Surgery: Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation."
10820660|NCT00060606|OG001|Outcome|Postnatal Surgery|"Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.~Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect"
10820661|NCT00060606|EG000|Reported Event|Prenatal Surgery Group|"Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.~Prenatal Myelomeningocele Repair Surgery: Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation."
10820662|NCT00060606|EG001|Reported Event|Postnatal Surgery Group|"Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.~Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect"
10820663|NCT00060840|BG000|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
10820664|NCT00060840|BG001|Baseline|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
10820665|NCT00060840|BG002|Baseline|Total|Total of all reporting groups
10806524|NCT05096312|BG000|Baseline|Zinc Gluconate Group|"interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.~Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Zinc gluconate: oral zinc gluconate 200mg~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening"
10806525|NCT05096312|BG001|Baseline|Placebo Group|"interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening~Placebo: contains cornstarch"
10806526|NCT05096312|BG002|Baseline|Total|Total of all reporting groups
10806527|NCT05096312|FG000|Participant Flow|Zinc Gluconate Group|"interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.~Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Zinc gluconate: oral zinc gluconate 200mg~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening"
10806528|NCT05096312|FG001|Participant Flow|Placebo Group|"interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening~Placebo: contains cornstarch"
10806529|NCT05096312|OG000|Outcome|Zinc Gluconate Group|"interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.~Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Zinc gluconate: oral zinc gluconate 200mg~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening"
10806530|NCT05096312|OG001|Outcome|Placebo Group|"interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening~Placebo: contains cornstarch"
10806531|NCT05096312|EG000|Reported Event|Zinc Gluconate Group|"interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.~Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Zinc gluconate: oral zinc gluconate 200mg~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening"
10806532|NCT05096312|EG001|Reported Event|Placebo Group|"interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.~Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening~Placebo: contains cornstarch"
10806533|NCT02853344|BG000|Baseline|Cohort A: Clear Cell Renal Cell Carcinoma (RCC)|Participants with clear cell RCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
10806534|NCT02853344|BG001|Baseline|Cohort B: Non-clear Cell RCC|Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806535|NCT02853344|BG002|Baseline|Total|Total of all reporting groups
10806536|NCT02853344|FG000|Participant Flow|Cohort A: Clear Cell Renal Cell Carcinoma (RCC)|Participants with clear cell RCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
10806537|NCT02853344|FG001|Participant Flow|Cohort B: Non-clear Cell RCC|Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806538|NCT02853344|OG000|Outcome|Cohort A: Clear Cell RCC|Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806539|NCT02853344|OG001|Outcome|Cohort B: Non-clear Cell RCC|Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806540|NCT02853344|EG000|Reported Event|Cohort A: ccRCC First Course|Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806541|NCT02853344|EG001|Reported Event|Cohort B: nccRCC First Course|Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
10806542|NCT02853344|EG002|Reported Event|Cohort A: ccRCC Second Course|Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
10806543|NCT02853344|EG003|Reported Event|Cohort B: nccRCC Second Course|Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
10806544|NCT03560258|BG000|Baseline|Arm A: p24CE/Full-length Gag DNA|"Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55^gag pDNA vaccine at Weeks 12 and 24.~p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation~p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation"
10806545|NCT03560258|BG001|Baseline|Arm B: Full-length Gag DNA|"Participants received full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24.~Full-length p55^gag pDNA vaccine: 4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation"
10806546|NCT03560258|BG002|Baseline|Arm C: Placebo|"Participants received placebo at Weeks 0, 4, 12, and 24.~Placebo: 1 mL placebo administered by one injection/electroporation"
11244237|NCT02509156|BG001|Baseline|Placebo|"Buminate solution~Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
10806547|NCT03560258|BG003|Baseline|Total|Total of all reporting groups
11244238|NCT02509156|BG002|Baseline|Total|Total of all reporting groups
10806548|NCT03560258|FG000|Participant Flow|Arm A: p24CE/Full-length Gag DNA|"Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55^gag pDNA vaccine at Weeks 12 and 24.~p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation~p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation"
10806549|NCT03560258|FG001|Participant Flow|Arm B: Full-length Gag DNA|"Participants received full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24.~Full-length p55^gag pDNA vaccine: 4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation"
10806550|NCT03560258|FG002|Participant Flow|Arm C: Placebo|"Participants received placebo at Weeks 0, 4, 12, and 24.~Placebo: 1 mL placebo administered by one injection/electroporation"
10806551|NCT03560258|OG000|Outcome|Arm A: p24CE/Full-length Gag DNA|"Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55^gag pDNA vaccine at Weeks 12 and 24.~p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation~p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation"
10806552|NCT03560258|OG001|Outcome|Arm B: Full-length Gag DNA|"Participants received full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24.~Full-length p55^gag pDNA vaccine: 4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation"
10806553|NCT03560258|OG002|Outcome|Arm C: Placebo|"Participants received placebo at Weeks 0, 4, 12, and 24.~Placebo: 1 mL placebo administered by one injection/electroporation"
10806554|NCT03560258|EG000|Reported Event|ArmA|"Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55^gag pDNA vaccine at Weeks 12 and 24.~p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation~p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation"
10806555|NCT03560258|EG001|Reported Event|ArmB|"Participants received full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24.~Full-length p55^gag pDNA vaccine: 4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation"
10806556|NCT03560258|EG002|Reported Event|ArmC|"Participants received placebo at Weeks 0, 4, 12, and 24.~Placebo: 1 mL placebo administered by one injection/electroporation"
10820666|NCT00060840|FG000|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
10820667|NCT00060840|FG001|Participant Flow|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
10820668|NCT00060840|OG000|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
11205036|NCT02225223|BG001|Baseline|Failed/Refuse Further Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
10820669|NCT00060840|OG001|Outcome|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
11205037|NCT02225223|BG002|Baseline|Total|Total of all reporting groups
10820670|NCT00060840|EG000|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
10820671|NCT00060840|EG001|Reported Event|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
10820672|NCT00060944|BG000|Baseline|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
10820673|NCT00060944|BG001|Baseline|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
10820674|NCT00060944|BG002|Baseline|Total|Total of all reporting groups
10820675|NCT00060944|FG000|Participant Flow|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
10820676|NCT00060944|FG001|Participant Flow|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
10820677|NCT00060944|OG000|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
11205038|NCT02225223|FG000|Participant Flow|No Previous Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
10820678|NCT00060944|OG001|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
11205039|NCT02225223|FG001|Participant Flow|Failed/Refuse Further Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
11205040|NCT02225223|OG000|Outcome|No Previous Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
10806557|NCT03684304|BG000|Baseline|Control / No Binder|Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
10806558|NCT03684304|BG001|Baseline|Abdominal Binder|"Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.~Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed."
10806559|NCT03684304|BG002|Baseline|Total|Total of all reporting groups
10806560|NCT03684304|FG000|Participant Flow|Control / No Binder|Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
10806561|NCT03684304|FG001|Participant Flow|Abdominal Binder|"Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.~Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed."
10806562|NCT03684304|OG000|Outcome|Control / No Binder|Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
10806563|NCT03684304|OG001|Outcome|Abdominal Binder|"Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.~Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed."
10806564|NCT03684304|EG000|Reported Event|Control / No Binder|Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
10806565|NCT03684304|EG001|Reported Event|Abdominal Binder|"Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.~Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed."
10806566|NCT03275168|BG000|Baseline|Control|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention~Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use."
10806567|NCT03275168|BG001|Baseline|Intervention|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner~Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male)."
10806568|NCT03275168|BG002|Baseline|Total|Total of all reporting groups
10806569|NCT03275168|FG000|Participant Flow|Control|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention~Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use."
10806570|NCT03275168|FG001|Participant Flow|Intervention|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner~Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male)."
10806571|NCT03275168|OG000|Outcome|Control|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention~Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use."
10806572|NCT03275168|OG001|Outcome|Intervention|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner~Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male)."
10820679|NCT00060944|EG000|Reported Event|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
10806573|NCT03275168|EG000|Reported Event|Control|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention~Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use."
10806574|NCT03275168|EG001|Reported Event|Intervention|"Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner~Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male)."
10820680|NCT00060944|EG001|Reported Event|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
10820681|NCT00061048|BG000|Baseline|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
10820682|NCT00061048|FG000|Participant Flow|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
10820683|NCT00061048|OG000|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
10820684|NCT00061048|EG000|Reported Event|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
10820685|NCT00061373|BG000|Baseline|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820686|NCT00061373|BG001|Baseline|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820687|NCT00061373|BG002|Baseline|Total|Total of all reporting groups
10820688|NCT00061373|FG000|Participant Flow|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820689|NCT00061373|FG001|Participant Flow|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820690|NCT00061373|OG000|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820691|NCT00061373|OG001|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820692|NCT00061373|EG000|Reported Event|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820693|NCT00061373|EG001|Reported Event|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
10820694|NCT00061633|BG000|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
10820695|NCT00061633|BG001|Baseline|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
10820696|NCT00061633|BG002|Baseline|Total|Total of all reporting groups
10820697|NCT00061633|FG000|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
10820698|NCT00061633|FG001|Participant Flow|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
11205041|NCT02225223|OG001|Outcome|Failed/Refuse Further Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
11205042|NCT02225223|EG000|Reported Event|No Previous Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
10806575|NCT04528641|BG000|Baseline|Arm 1 - Low Dose|"Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806576|NCT04528641|BG001|Baseline|Arm 2 - Intermediate Dose|"Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806577|NCT04528641|BG002|Baseline|Arm 3 - High Dose|"Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806578|NCT04528641|BG003|Baseline|Arm 4 - Low Dose|"Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16~GRAd-COV2: Single intramuscular administration."
10806579|NCT04528641|BG004|Baseline|Arm 5 - Intermediate Dose|"Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806580|NCT04528641|BG005|Baseline|Arm 6 - High Dose|"Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806581|NCT04528641|BG006|Baseline|Total|Total of all reporting groups
10806582|NCT04528641|FG000|Participant Flow|Arm 1 - Low Dose|"Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806583|NCT04528641|FG001|Participant Flow|Arm 2 - Intermediate Dose|"Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806584|NCT04528641|FG002|Participant Flow|Arm 3 - High Dose|"Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
11205043|NCT02225223|EG001|Reported Event|Failed/Refuse Further Radiation Therapy|"Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.~STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)~StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)"
10806585|NCT04528641|FG003|Participant Flow|Arm 4 - Low Dose|"Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806586|NCT04528641|FG004|Participant Flow|Arm 5 - Intermediate Dose|"Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806587|NCT04528641|FG005|Participant Flow|Arm 6 - High Dose|"Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806588|NCT04528641|OG000|Outcome|Arm 1 - Low Dose|"Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806589|NCT04528641|OG001|Outcome|Arm 2 - Intermediate Dose|"Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806590|NCT04528641|OG002|Outcome|Arm 3 - High Dose|"Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806591|NCT04528641|OG003|Outcome|Arm 4 - Low Dose|"Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16~GRAd-COV2: Single intramuscular administration."
10806592|NCT04528641|OG004|Outcome|Arm 5 - Intermediate Dose|"Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806593|NCT04528641|OG005|Outcome|Arm 6 - High Dose|"Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806594|NCT04528641|OG000|Outcome|Arm 1 - Low Dose|"Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14~GRAd-COV2: Single intramuscular administration."
10806595|NCT04528641|OG003|Outcome|Arm 4 - Low Dose|"Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806596|NCT04528641|OG003|Outcome|Arm 4 - Low Dose|Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.
10806597|NCT04528641|EG000|Reported Event|Arm 1 - Low Dose|"Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15~GRAd-COV2: Single intramuscular administration."
10806598|NCT04528641|EG001|Reported Event|Arm 2 - Intermediate Dose|"Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806599|NCT04528641|EG002|Reported Event|Arm 3 - High Dose|"Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806600|NCT04528641|EG003|Reported Event|Arm 4 - Low Dose|"Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16~GRAd-COV2: Single intramuscular administration."
11205044|NCT02225353|BG000|Baseline|Progesterone Cervical Pessary (6.3 g)|Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal.
11205045|NCT02225353|BG001|Baseline|Progesterone Cervical Pessary (7.7 g)|Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal.
11205046|NCT02225353|BG002|Baseline|Progesterone 200 mg Vaginal Capsules|Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant.
11205047|NCT02225353|BG003|Baseline|Total|Total of all reporting groups
10806601|NCT04528641|EG004|Reported Event|Arm 5 - Intermediate Dose|"Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806602|NCT04528641|EG005|Reported Event|Arm 6 - High Dose|"Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15~GRAd-COV2: Single intramuscular administration."
10806603|NCT04497883|BG000|Baseline|Cohort A: Non-Hispanic, Caucasian|Non-Hispanic, Caucasian participants received 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
10806604|NCT04497883|BG001|Baseline|Cohort B: Japanese Descent|Japanese descent participants received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
10806605|NCT04497883|BG002|Baseline|Total|Total of all reporting groups
10806606|NCT04497883|FG000|Participant Flow|Cohort A: Non-Hispanic, Caucasian|Non-Hispanic, Caucasian participants received single dose of 400 milligram (mg) maribavir tablets orally on Day 1 during treatment period 1.
10806607|NCT04497883|FG001|Participant Flow|Cohort B: Japanese Descent: Maribavir 400mg|Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
10806608|NCT04497883|FG002|Participant Flow|Cohort B: Japanese Descent: First Maribavir 200 mg Then Maribavir 800 mg|Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 2 followed by single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
10806609|NCT04497883|FG003|Participant Flow|Cohort B: Japanese Descent: First Maribavir 800 mg Then Maribavir 200 mg|Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
10806610|NCT04497883|OG000|Outcome|Cohort A: Maribavir 400 mg|Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
10806611|NCT04497883|OG001|Outcome|Cohort B: Maribavir 400 mg|Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
10806612|NCT04497883|OG002|Outcome|Cohort B: Maribavir 200 mg|Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
10806613|NCT04497883|OG003|Outcome|Cohort B: Maribavir 800 mg|Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
10806614|NCT04497883|OG000|Outcome|Cohort B: Japanese Descent|All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
10806615|NCT04497883|EG000|Reported Event|Cohort A: Maribavir 400 mg|Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
10806616|NCT04497883|EG001|Reported Event|Cohort B: Maribavir 400 mg|Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
10806617|NCT04497883|EG002|Reported Event|Cohort B: Maribavir 200 mg|Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
10806618|NCT04497883|EG003|Reported Event|Cohort B: Maribavir 800 mg|Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
10806619|NCT04034238|BG000|Baseline|Dose Escalation Dose Level 1 LMB-100 100 mcg/kg|"LMB-100 at escalating doses plus tofacitinib~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.~Mesothelin Expression: Test for mesothelin expression in tumor tissues for study eligibility"
10806620|NCT04034238|BG001|Baseline|Dose Escalation Dose Level 2 LMB-100 140 mcg/kg|"LMB-100 at escalating doses plus tofacitinib~LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.~Mesothelin Expression: Test for mesothelin expression in tumor tissues for study eligibility"
10806621|NCT04034238|BG002|Baseline|Dose Expansion LMB-100, 100 mcg/kg|"LMB-100 at optimal dose plus tofacitinib~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806622|NCT04034238|BG003|Baseline|Total|Total of all reporting groups
10806623|NCT04034238|FG000|Participant Flow|Dose Escalation- Dose Level 1 LMB-100 100 mcg/kg|"LMB-100 at escalating doses plus tofacitinib~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.~Mesothelin Expression: Test for mesothelin expression in tumor tissues for study eligibility"
10806624|NCT04034238|FG001|Participant Flow|Dose Escalation- Dose Level 2 - LMB -100 140 mcg/kg|"LMB-100 at escalating doses plus tofacitinib~LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.~Mesothelin Expression: Test for mesothelin expression in tumor tissues for study eligibility"
10820699|NCT00061633|OG000|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
10806625|NCT04034238|FG002|Participant Flow|Dose Expansion LMB-100 100 mcg/kg|"LMB-100 at optimal dose plus tofacitinib~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806626|NCT04034238|FG003|Participant Flow|Enrolled But Not Treated|Participants were enrolled but not treated.
10806627|NCT04034238|OG000|Outcome|All Participants in Dose Escalation Dose Level 1, and Dose Level 2|All Participants in Dose Escalation Dose Level 1, and Dose Level 2 administered LMB-100: Both Arms intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 and Tofacitinib orally twice daily on days 1-10 of each cycle, and LMB-100.
10806628|NCT04034238|OG000|Outcome|Dose Expansion LMB-100, 100 mcg/kg|"LMB-100 at optimal dose plus tofacitinib - 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806629|NCT04034238|OG000|Outcome|Dose Escalation Dose Level 1 LMB-100 100 mcg/kg|"LMB-100 100 mcg/kg~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806630|NCT04034238|OG001|Outcome|Dose Escalation Dose Level 2 LMB-100 140 mcg/kg|"LMB-100 140 mcg/kg~LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806631|NCT04034238|OG002|Outcome|Dose Expansion LMB-100, 100 mcg/kg|"LMB-100 at optimal dose plus tofacitinib - 100 mcg/kg LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806632|NCT04034238|OG000|Outcome|Dose Escalation- Dose Level 1 LMB-100 100 mcg/kg|"LMB-100 100 mcg/kg~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806633|NCT04034238|EG000|Reported Event|Dose Escalation Dose Level 1 LMB-100 100 mcg/kg|"LMB-100 100 mcg/kg~LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806634|NCT04034238|EG001|Reported Event|Dose Escalation Dose Level 2 LMB-100 140 mcg/kg|"LMB-100 140 mcg/kg~LMB-100: Arms 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10806635|NCT04034238|EG002|Reported Event|Dose Expansion LMB-100, 100 mcg/kg|"LMB-100 at optimal dose plus tofacitinib - 100 mcg/kg~LMB-100 at optimal dose plus tofacitinib LMB-100: Arms 1: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.~Tofacitinib: Arms 1: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study."
10820700|NCT00061633|OG001|Outcome|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
10820701|NCT00061633|EG000|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
10820702|NCT00061633|EG001|Reported Event|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
10820703|NCT00061893|BG000|Baseline|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
10820704|NCT00061893|FG000|Participant Flow|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
10806636|NCT03984305|BG000|Baseline|PKG+ Group|"For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is controlled or uncontrolled based on scores provided by the PKG.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording.~Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.~The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
10806637|NCT03984305|BG001|Baseline|PKG- Group|"For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording."
10806638|NCT03984305|BG002|Baseline|Total|Total of all reporting groups
10806639|NCT03984305|FG000|Participant Flow|PKG+ Group|"For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is controlled or uncontrolled based on scores provided by the PKG.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording.~Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.~The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
10806640|NCT03984305|FG001|Participant Flow|PKG- Group|"For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording."
10806641|NCT03984305|OG000|Outcome|PKG+ Group|"For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is controlled or uncontrolled based on scores provided by the PKG.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording.~Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.~The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
10806642|NCT03984305|OG001|Outcome|PKG- Group|"For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording."
10847547|NCT00283803|OG000|Outcome|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
10847548|NCT00283803|EG000|Reported Event|Exisulind|"Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.~Exisulind: Exisulind 125 mg"
10847549|NCT00283816|BG000|Baseline|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
10847550|NCT00283816|BG001|Baseline|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
10847551|NCT00283816|BG002|Baseline|Total|Total of all reporting groups
10806643|NCT03984305|EG000|Reported Event|PKG+ Group|"For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is controlled or uncontrolled based on scores provided by the PKG.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording.~Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.~The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
10806644|NCT03984305|EG001|Reported Event|PKG- Group|"For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.~Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~An application to configure the data logger and transfer the acquired data at the end of a recording."
10806645|NCT03982368|BG000|Baseline|rhNGF 20 μg/ml TID|"One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)~rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)"
10806646|NCT03982368|BG001|Baseline|rhNGF 20 μg/ml BID + Vehicle OD|"One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)~rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
10806647|NCT03982368|BG002|Baseline|Vehicle TID|"Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)~Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)"
10806648|NCT03982368|BG003|Baseline|Total|Total of all reporting groups
10806649|NCT03982368|FG000|Participant Flow|rhNGF 20 μg/ml TID|"One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)~rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)"
10806650|NCT03982368|FG001|Participant Flow|rhNGF 20 μg/ml BID + Vehicle OD|"One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)~rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
10806651|NCT03982368|FG002|Participant Flow|Vehicle TID|"Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)~Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)"
10806652|NCT03982368|OG000|Outcome|rhNGF 20 μg/ml TID|"One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)~rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)"
10806653|NCT03982368|OG001|Outcome|rhNGF 20 μg/ml BID + Vehicle OD|"One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)~rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
10806654|NCT03982368|OG002|Outcome|Vehicle TID|"Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)~Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)"
10806655|NCT03982368|EG000|Reported Event|rhNGF 20 μg/ml TID - Treatment Period|"One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)~rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)"
10806656|NCT03982368|EG001|Reported Event|rhNGF 20 μg/ml BID + Vehicle OD - Treatment Period|"One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)~rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
10806657|NCT03982368|EG002|Reported Event|Vehicle TID - Treatment Period|"Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)~Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)"
10806658|NCT03982368|EG003|Reported Event|rhNGF 20 μg/ml TID - Follow-up Period|"One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)~rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)"
10806659|NCT03982368|EG004|Reported Event|rhNGF 20 μg/ml BID + Vehicle OD - Follow-up Period|"One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)~rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
10847552|NCT00283816|FG000|Participant Flow|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
10806660|NCT03982368|EG005|Reported Event|Vehicle TID - Follow up Period|"Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)~Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)"
10806661|NCT03952143|BG000|Baseline|Insulin Lispro (Humalog)|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806662|NCT03952143|BG001|Baseline|LY900014|Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806663|NCT03952143|BG002|Baseline|Total|Total of all reporting groups
10806664|NCT03952143|FG000|Participant Flow|Insulin Lispro (Humalog) Lead-in|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806665|NCT03952143|FG001|Participant Flow|Insulin Lispro (Humalog)|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806666|NCT03952143|FG002|Participant Flow|LY900014|Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806667|NCT03952143|OG000|Outcome|Insulin Lispro (Humalog)|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806668|NCT03952143|OG001|Outcome|LY900014|Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806669|NCT03952143|EG000|Reported Event|Insulin Lispro (Humalog) Lead-in|Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806670|NCT03952143|EG001|Reported Event|Insulin Lispro (Humalog)|Participants received 100 U/mL insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806671|NCT03952143|EG002|Reported Event|LY900014|Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
10806672|NCT03924752|BG000|Baseline|Healthy Individuals Using a Powered Hip Exoskeleton|"This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion."
10806673|NCT03924752|FG000|Participant Flow|Healthy Individuals Using a Powered Hip Exoskeleton|"This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion."
10806674|NCT03924752|OG000|Outcome|Healthy Individuals Using a Powered Hip Exoskeleton|"This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion."
10806675|NCT03924752|EG000|Reported Event|Healthy Individuals Using a Powered Hip Exoskeleton|"This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures).~Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion."
10806676|NCT03829514|BG000|Baseline|Fenofibrate|"Single arm. Participants will take study medication~Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up."
10806677|NCT03829514|FG000|Participant Flow|Fenofibrate|"Single arm. Participants will take study medication~Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up."
10806678|NCT03829514|OG000|Outcome|Fenofibrate|"Single arm. Participants will take study medication~Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up."
10806679|NCT03829514|EG000|Reported Event|Fenofibrate|"Single arm. Participants will take study medication~Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up."
10806680|NCT03691428|BG000|Baseline|Intervention|"Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10847553|NCT00283816|FG001|Participant Flow|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
10847554|NCT00283816|OG000|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
10847555|NCT00283816|OG001|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
10847556|NCT00283816|OG000|Outcome|Metformin|metformin 2000mg in addition to oral contraceptive
10847557|NCT00283816|OG001|Outcome|Placebo|placebo pill in addition to oral contraceptive
10806681|NCT03691428|BG001|Baseline|Wait-list|"Participants will get the WOOP training after the last outcome assessment.~Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806682|NCT03691428|BG002|Baseline|Total|Total of all reporting groups
10806683|NCT03691428|FG000|Participant Flow|Intervention|"Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806684|NCT03691428|FG001|Participant Flow|Wait-list|"Participants will get the WOOP training after the last outcome assessment.~Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806685|NCT03691428|OG000|Outcome|Intervention|"Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806686|NCT03691428|OG001|Outcome|Wait-list|"Participants will get the WOOP training after the last outcome assessment.~Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806687|NCT03691428|EG000|Reported Event|Intervention|"Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10822120|NCT00074581|BG001|Baseline|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
10822121|NCT00074581|BG002|Baseline|Total|Total of all reporting groups
10847558|NCT00283816|EG000|Reported Event|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
11244239|NCT02509156|FG000|Participant Flow|Allo-MSCs|"Target dose of 100 million allo-MSCs~Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
11244240|NCT02509156|FG001|Participant Flow|Placebo|"Buminate solution~Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
11244241|NCT02509156|OG000|Outcome|Allo-MSCs|"Target dose of 100 million allo-MSCs~Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
10806688|NCT03691428|EG001|Reported Event|Wait-list|"Participants will get the WOOP training after the last outcome assessment.~Wish Outcome Obstacle Plan: 1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
10806689|NCT03685708|BG000|Baseline|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806690|NCT03685708|BG001|Baseline|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806691|NCT03685708|BG002|Baseline|Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve|Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806692|NCT03685708|BG003|Baseline|Total|Total of all reporting groups
10806693|NCT03685708|FG000|Participant Flow|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806694|NCT03685708|FG001|Participant Flow|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806695|NCT03685708|FG002|Participant Flow|Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve|Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806696|NCT03685708|OG000|Outcome|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806697|NCT03685708|OG001|Outcome|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806698|NCT03685708|OG002|Outcome|Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve|Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806699|NCT03685708|EG000|Reported Event|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib|Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806700|NCT03685708|EG001|Reported Event|Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib|Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806701|NCT03685708|EG002|Reported Event|Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve|Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
10806702|NCT03669588|BG000|Baseline|ARGX-113|Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806703|NCT03669588|BG001|Baseline|Placebo|Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806704|NCT03669588|BG002|Baseline|Total|Total of all reporting groups
10847559|NCT00283816|EG001|Reported Event|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
10806705|NCT03669588|FG000|Participant Flow|ARGX-113|"Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.~Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale."
10806706|NCT03669588|FG001|Participant Flow|Placebo|"Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.~Each 8-week TC comprised a 3-week treatment period and a 5-week follow-up period. At the end of each TC, patients entered the ITC period consisting of visits every 2 weeks. At each ITC visit, retreatment criteria were evaluated to determine if the patient was eligible to enter the next cycle for retreatment, based on clinical response as measured by the MG-ADL scale."
10806707|NCT03669588|OG000|Outcome|ARGX-113|Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806708|NCT03669588|OG001|Outcome|Placebo|Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806709|NCT03669588|EG000|Reported Event|ARGX-113|Patients received ARGX-113 IV 10 mg/kg administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806710|NCT03669588|EG001|Reported Event|Placebo|Patients received matching placebo administered as a 1-hour infusion every 7 days for 4 infusions (Days 1, 8, 15, and 22) in each cycle.
10806711|NCT03531632|BG000|Baseline|Dose Level 1|0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806712|NCT03531632|BG001|Baseline|Dose Level 2|0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806713|NCT03531632|BG002|Baseline|Dose Level 3|0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806714|NCT03531632|BG003|Baseline|Total|Total of all reporting groups
10806715|NCT03531632|FG000|Participant Flow|Dose Level 1|0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806716|NCT03531632|FG001|Participant Flow|Dose Level 2|0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806717|NCT03531632|FG002|Participant Flow|Dose Level 3|0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806718|NCT03531632|OG000|Outcome|Dose Level 1|0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806719|NCT03531632|OG001|Outcome|Dose Level 2|0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806720|NCT03531632|OG002|Outcome|Dose Level 3|0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806721|NCT03531632|OG000|Outcome|MGD007 + MGA012|"MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody.~MGD007 + MGA012: MGD007 and MGA012 are administered by IV infusion."
10806722|NCT03531632|EG000|Reported Event|Dose Level 1|0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806723|NCT03531632|EG001|Reported Event|Dose Level 2|0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806724|NCT03531632|EG002|Reported Event|Dose Level 3|0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
10806725|NCT03488030|BG000|Baseline|Crohn's Disease|Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806726|NCT03488030|BG001|Baseline|Ulcerative Colitis|Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806727|NCT03488030|BG002|Baseline|Total|Total of all reporting groups
10806728|NCT03488030|FG000|Participant Flow|Crohn's Disease|Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10847560|NCT00283842|BG000|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847561|NCT00283842|BG001|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11205048|NCT02225353|FG000|Participant Flow|Progesterone Cervical Pessary (6.3 g)|Cervical Pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant at risk of preterm birth and remains installed with no further intervention except at the time of removal.
10847562|NCT00283842|BG002|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10806729|NCT03488030|FG001|Participant Flow|Ulcerative Colitis|Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806730|NCT03488030|OG000|Outcome|Crohn's Disease|Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806731|NCT03488030|OG000|Outcome|Ulcerative Colitis|Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806732|NCT03488030|OG001|Outcome|Ulcerative Colitis|Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806733|NCT03488030|OG000|Outcome|Crohn's Disease (Moderate to Severe)|Participants diagnosed with moderate to severe CD (HBI score >=8 points and CDAI score >=220 points) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806734|NCT03488030|OG001|Outcome|Crohn's Disease (no or Mild)|Participants diagnosed with no or mild CD (HBI score <8 points and CDAI score < 220 points) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806735|NCT03488030|OG002|Outcome|Ulcerative Colitis (Moderate to Severe)|Participants diagnosed with moderate to severe UC (9-point pMayo score >=5) for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10847563|NCT00283842|BG003|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11205049|NCT02225353|FG001|Participant Flow|Progesterone Cervical Pessary (7.7 g)|Cervical Pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant at risk of preterm birth and remains installed with no further intervention except at the time of removal.
11205050|NCT02225353|FG002|Participant Flow|Progesterone 200 mg Vaginal Capsules|Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant.
11205051|NCT02225353|OG000|Outcome|Progesterone Cervical Pessary (6.3 g)|Cervical Pessary with sustained release of progesterone.Single placement and removal by investigator site.
11205052|NCT02225353|OG001|Outcome|Progesterone Cervical Pessary (7.7 g)|Cervical Pessary with sustained release of progesterone. Single placement and removal by investigator site.
10847564|NCT00283842|BG004|Baseline|Placebo|
11205053|NCT02225353|OG002|Outcome|Progesterone 200 mg Vaginal Capsules|Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant.
11205054|NCT02225353|OG000|Outcome|Progesterone Cervical Pessary (6.3 g)|Cervical Pessary with sustained release of progesterone. Single placement and removal by investigator site.
11205055|NCT02225353|OG000|Outcome|Progesterone Cervical Pessary (6.3 g)|Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal.
11205056|NCT02225353|OG001|Outcome|Progesterone Cervical Pessary (7.7 g)|Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal.
11205057|NCT02225353|EG000|Reported Event|Progesterone Cervical Pessary 6.3 g|"91 pregnant women with Progesterone Cervical Pessary~Progesterone Cervical Pessary: Progesterone Cervical Pessary: 6.3 g Progesterone Cervical Pessary: 7.7 g"
11205058|NCT02225353|EG001|Reported Event|Progesterone Cervical Pessary 7.7 g|"90 pregnant women with Progesterone Cervical Pessary~Progesterone Cervical Pessary: Progesterone Cervical Pessary: 6.3 g Progesterone Cervical Pessary: 7.7 g"
11205059|NCT02225353|EG002|Reported Event|Progesterone 200 mg Vaginal Capsules|"90 pregnant women using Progesterone 200 mg vaginal capsules daily~Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily"
11205060|NCT02225587|BG000|Baseline|Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205061|NCT02225587|BG001|Baseline|Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205062|NCT02225587|BG002|Baseline|Total|Total of all reporting groups
10847565|NCT00283842|BG005|Baseline|Total|Total of all reporting groups
10806736|NCT03488030|OG003|Outcome|Ulcerative Colitis (no or Mild)|Participants diagnosed with no or mild UC (9-point pMayo score <5) from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806737|NCT03488030|EG000|Reported Event|Crohn's Disease|Participants diagnosed with moderate to severe CD for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806738|NCT03488030|EG001|Reported Event|Ulcerative Colitis|Participants diagnosed with moderate to severe UC for at least 6 months prior to Day 1 appointment from the 7 participating sites were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
10806739|NCT03412604|BG000|Baseline|tACS|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 20 sessions on consecutive weekdays. The tACS intervention (20 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and MRI and cognitive function.~Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10806740|NCT03412604|FG000|Participant Flow|tACS|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 20 sessions on consecutive weekdays. The tACS intervention (20 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and MRI and cognitive function.~Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10806741|NCT03412604|OG000|Outcome|tACS|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 20 sessions on consecutive weekdays. The tACS intervention (20 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and MRI and cognitive function.~Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10806742|NCT03412604|EG000|Reported Event|tACS|"Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 20 sessions on consecutive weekdays. The tACS intervention (20 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and MRI and cognitive function.~Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region."
10820705|NCT00061893|OG000|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
10847566|NCT00283842|FG000|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847567|NCT00283842|FG001|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11244242|NCT02509156|OG001|Outcome|Placebo|"Buminate solution~Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
11244243|NCT02509156|EG000|Reported Event|Allo-MSCs|"Target dose of 100 million allo-MSCs~Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
11244244|NCT02509156|EG001|Reported Event|Placebo|"Buminate solution~Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)"
10806743|NCT03206073|BG000|Baseline|1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg|Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806744|NCT03206073|BG001|Baseline|2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg|Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806745|NCT03206073|BG002|Baseline|3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806746|NCT03206073|BG003|Baseline|4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806747|NCT03206073|BG004|Baseline|Total|Total of all reporting groups
10806748|NCT03206073|FG000|Participant Flow|1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg|Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806749|NCT03206073|FG001|Participant Flow|2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg|Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
11205063|NCT02225587|FG000|Participant Flow|Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205064|NCT02225587|FG001|Participant Flow|Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
10806750|NCT03206073|FG002|Participant Flow|3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806751|NCT03206073|FG003|Participant Flow|4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806752|NCT03206073|OG000|Outcome|1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg|Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806753|NCT03206073|OG001|Outcome|2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg|Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806754|NCT03206073|OG002|Outcome|3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806755|NCT03206073|OG003|Outcome|4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806756|NCT03206073|EG000|Reported Event|1/Arm A1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg|Cohort A/Dose Level 1 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806757|NCT03206073|EG001|Reported Event|2/Arm A2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) +Durvalumab 1500 mg|Cohort A/Dose Level 2 Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806758|NCT03206073|EG002|Reported Event|3/Arm B1 Pexa-Vec 3 x 10E^8 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 1 Tremelimumab 300mg 1x; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 3 x 10^8/plaque-forming unit(pfu)
10806759|NCT03206073|EG003|Reported Event|4/Arm B2 Pexa-Vec 1 x 10E^9 Plaque-forming Unit (Pfu) + Durvalumab 1500 mg +Tremelimumab 300 mg|Cohort B/Dose Level 2 Tremelimumab 300mg; Durvalumab 1500mg every(q) 28 day(d); Pexa-Vec 1 x 10^9/plaque-forming unit(pfu)
10806760|NCT03195127|BG000|Baseline|Multimodal Physical Therapy|"Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.~multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist"
10806761|NCT03195127|BG001|Baseline|Usual Care|Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
10806762|NCT03195127|BG002|Baseline|Total|Total of all reporting groups
10847568|NCT00283842|FG002|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847569|NCT00283842|FG003|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847570|NCT00283842|FG004|Participant Flow|Placebo|
11205065|NCT02225587|OG000|Outcome|Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205066|NCT02225587|OG001|Outcome|Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205067|NCT02225587|EG000|Reported Event|Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11244245|NCT02509481|BG000|Baseline|Single MDA|"Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.~Ivermectin~Albendazole"
10806763|NCT03195127|FG000|Participant Flow|Multimodal Physical Therapy|"Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.~multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist"
10806764|NCT03195127|FG001|Participant Flow|Usual Care|Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
10806765|NCT03195127|OG000|Outcome|Multimodal Physical Therapy|"Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.~multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist"
10806766|NCT03195127|OG001|Outcome|Usual Care|Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
10806767|NCT03195127|OG000|Outcome|Multimodal Physical Therapy|Exercise intervention group - 4 meter gait speed in meters per second.
10806768|NCT03195127|OG001|Outcome|Usual Care|Control Group -4 meter gait speed in meters per second
10806769|NCT03195127|OG000|Outcome|Multimodal Physical Therapy|Exercise intervention group distance walked in 6 minutes in meters
10806770|NCT03195127|OG001|Outcome|Usual Care|Usual care group distance walked in 6 minutes in meters
10806771|NCT03195127|EG000|Reported Event|Multimodal Physical Therapy|"Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.~multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist"
10806772|NCT03195127|EG001|Reported Event|Usual Care|Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
11205068|NCT02225587|EG001|Reported Event|Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23|Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
11205069|NCT02225665|BG000|Baseline|Cohort 1|"SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
11205070|NCT02225665|BG001|Baseline|Cohort 2|"SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
10806773|NCT03102034|BG000|Baseline|RSV D46/NS2/N/ΔM2-2-HindIII Vaccine|"Participants received a single dose of the D46/NS2/N/ΔM2-2-HindIII vaccine at study entry (Day 0).~D46/NS2/N/ΔM2-2-HindIII: 10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops"
10806774|NCT03102034|BG001|Baseline|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent; administered as nose drops"
10806775|NCT03102034|BG002|Baseline|Total|Total of all reporting groups
10806776|NCT03102034|FG000|Participant Flow|RSV D46/NS2/N/ΔM2-2-HindIII Vaccine|"Participants received a single dose of the D46/NS2/N/ΔM2-2-HindIII vaccine at study entry (Day 0).~D46/NS2/N/ΔM2-2-HindIII: 10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops"
10806777|NCT03102034|FG001|Participant Flow|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent; administered as nose drops"
10806778|NCT03102034|OG000|Outcome|RSV D46/NS2/N/ΔM2-2-HindIII Vaccine|"Participants received a single dose of the D46/NS2/N/ΔM2-2-HindIII vaccine at study entry (Day 0).~D46/NS2/N/ΔM2-2-HindIII: 10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops"
10806779|NCT03102034|OG001|Outcome|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent; administered as nose drops"
10847571|NCT00283842|OG000|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11205071|NCT02225665|BG002|Baseline|Total|Total of all reporting groups
11205072|NCT02225665|FG000|Participant Flow|Cohort 1|"SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
11205073|NCT02225665|FG001|Participant Flow|Cohort 2|"SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
11205074|NCT02225665|OG000|Outcome|Cohort 1|"SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
11205075|NCT02225665|OG001|Outcome|Cohort 2|"SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
10806780|NCT03102034|EG000|Reported Event|Vaccine|"Participants received a single dose of the D46/NS2/N/ΔM2-2-HindIII vaccine at study entry (Day 0).~D46/NS2/N/ΔM2-2-HindIII: 10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops"
10806781|NCT03102034|EG001|Reported Event|Placebo|Participants received a single dose of placebo study entry (Day 0). Placebo: Isotonic diluent, administered as nose drops
10806782|NCT03076164|BG000|Baseline|Trametinib 1.5mg + Erlotinib 75mg|Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort. There would be no reason or utility to assess the phase 1 cohort separately since they received the same dose as the phase 2 cohort.
10806783|NCT03076164|FG000|Participant Flow|Trametinib 1.5mg + Erlotinib 75mg|"Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib~This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort. There would be no reason or utility to assess the phase 1 cohort separately since they received the same dose as the phase 2 cohort."
10806784|NCT03076164|OG000|Outcome|Trametinib 1.5mg + Erlotinib 75mg|"Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib~This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort. There would be no reason or utility to assess the phase 1 cohort separately since they received the same dose as the phase 2 cohort."
10806785|NCT03076164|EG000|Reported Event|Trametinib 1.5mg + Erlotinib 75mg|"Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib~This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort. There would be no reason or utility to assess the phase 1 cohort separately since they received the same dose as the phase 2 cohort."
10806786|NCT02723864|BG000|Baseline|Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806787|NCT02723864|BG001|Baseline|Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806788|NCT02723864|BG002|Baseline|Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806789|NCT02723864|BG003|Baseline|Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806790|NCT02723864|BG004|Baseline|Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
11205076|NCT02225665|EG000|Reported Event|Cohort 1|"SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
10806791|NCT02723864|BG005|Baseline|Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806792|NCT02723864|BG006|Baseline|Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806793|NCT02723864|BG007|Baseline|Total|Total of all reporting groups
10806794|NCT02723864|FG000|Participant Flow|Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806795|NCT02723864|FG001|Participant Flow|Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806796|NCT02723864|FG002|Participant Flow|Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806797|NCT02723864|FG003|Participant Flow|Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806798|NCT02723864|FG004|Participant Flow|Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806799|NCT02723864|FG005|Participant Flow|Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10847572|NCT00283842|OG001|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10806800|NCT02723864|FG006|Participant Flow|Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806801|NCT02723864|OG000|Outcome|Grade 2 Adverse Events - Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806802|NCT02723864|OG001|Outcome|Grade 3 Adverse Events - Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806803|NCT02723864|OG002|Outcome|Grade 4 Adverse Events - Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806804|NCT02723864|OG003|Outcome|Grade 2 Adverse Events - Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806805|NCT02723864|OG004|Outcome|Grade 3 Adverse Events - Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806806|NCT02723864|OG005|Outcome|Grade 4 Adverse Events - Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806807|NCT02723864|OG006|Outcome|Grade 2 Adverse Events - Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806808|NCT02723864|OG007|Outcome|Grade 3 Adverse Events - Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806809|NCT02723864|OG008|Outcome|Grade 4 Adverse Events - Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806810|NCT02723864|OG009|Outcome|Grade 2 Adverse Events - Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806811|NCT02723864|OG010|Outcome|Grade 3 Adverse Events - Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806812|NCT02723864|OG011|Outcome|Grade 4 Adverse Events - Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
11205077|NCT02225665|EG001|Reported Event|Cohort 2|"SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)~Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion"
10806813|NCT02723864|OG012|Outcome|Grade 2 Adverse Events - Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806814|NCT02723864|OG013|Outcome|Grade 3 Adverse Events - Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806815|NCT02723864|OG014|Outcome|Grade 4 Adverse Events - Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806816|NCT02723864|OG015|Outcome|Grade 2 Adverse Events - Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806817|NCT02723864|OG016|Outcome|Grade 3 Adverse Events - Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806818|NCT02723864|OG017|Outcome|Grade 4 Adverse Events - Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806819|NCT02723864|OG018|Outcome|Grade 2 Adverse Events - Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806820|NCT02723864|OG019|Outcome|Grade 3 Adverse Events - Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806821|NCT02723864|OG020|Outcome|Grade 4 Adverse Events - Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806822|NCT02723864|OG000|Outcome|Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806823|NCT02723864|OG001|Outcome|Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806824|NCT02723864|OG002|Outcome|Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806825|NCT02723864|OG003|Outcome|Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806826|NCT02723864|OG004|Outcome|Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806827|NCT02723864|OG005|Outcome|Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806828|NCT02723864|OG006|Outcome|Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806829|NCT02723864|EG000|Reported Event|Dose Level 1|DL 1: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 90 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806830|NCT02723864|EG001|Reported Event|Dose Level 2|DL 2: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 140 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr day 1 (optional after 6 cycles)
10806831|NCT02723864|EG002|Reported Event|Dose Level 3|DL 3: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 120 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806832|NCT02723864|EG003|Reported Event|Dose Level 4|DL 4: ABT-888 100 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806833|NCT02723864|EG004|Reported Event|Dose Level 5|DL 5: ABT-888 150 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806834|NCT02723864|EG005|Reported Event|Dose Level 6|DL 6: ABT-888 200 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 intravenous (IV) over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 IV over 1hr days 1 & 8 (optional after 6 cycles)
10806835|NCT02723864|EG006|Reported Event|Dose Level 7|DL 7: ABT-888 300 mg by mouth (PO) every (Q)12 hours on days 1-3 & 8-10, VX-970 210 mg/m^2 IV over 1 hour days 2 & 9, Cisplatin 40 mg/m^2 intravenous (IV) over 1hr days 1 & 8 (optional after 6 cycles)
10806836|NCT02701556|BG000|Baseline|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|B & L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
11205078|NCT02225743|BG000|Baseline|Joint Arthroplasty|"Participants undergoing joint replacement~Observation Of Temperature: Participants temperature will be recorded perioperatively."
11205079|NCT02225743|FG000|Participant Flow|Joint Arthroplasty|"Participants undergoing joint replacement~Observation Of Temperature: Participants temperature will be recorded perioperatively."
11205080|NCT02225743|OG000|Outcome|Hypothermia|Hypothermia was defined as a temperature less than 36.0 °C. .
11205081|NCT02225743|EG000|Reported Event|Joint Arthroplasty|"Participants undergoing joint replacement~Observation Of Temperature: Participants temperature will be recorded perioperatively."
10806837|NCT02701556|BG001|Baseline|COMPLETE Multi-Purpose Solution|B&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806838|NCT02701556|BG002|Baseline|Total|Total of all reporting groups
10806839|NCT02701556|FG000|Participant Flow|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|B & L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806840|NCT02701556|FG001|Participant Flow|COMPLETE Multi-Purpose Solution|B&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806841|NCT02701556|OG000|Outcome|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|B & L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806842|NCT02701556|OG001|Outcome|COMPLETE Multi-Purpose Solution|B&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806843|NCT02701556|EG000|Reported Event|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|B & L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806844|NCT02701556|EG001|Reported Event|COMPLETE Multi-Purpose Solution|B&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
10806845|NCT02691013|BG000|Baseline|Placebo|"Patients will receive a Placebo tablet every evening.~Placebo"
10806846|NCT02691013|BG001|Baseline|Ramelteon|"Patients will receive Ramelteon 8mg every evening.~Ramelteon"
10806847|NCT02691013|BG002|Baseline|Total|Total of all reporting groups
10806848|NCT02691013|FG000|Participant Flow|Placebo|"Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total.~Placebo"
10806849|NCT02691013|FG001|Participant Flow|Ramelteon|"Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total.~Ramelteon"
10806850|NCT02691013|OG000|Outcome|Placebo|"Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total.~Placebo"
10806851|NCT02691013|OG001|Outcome|Ramelteon|"Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total.~Ramelteon"
11205082|NCT02225860|BG000|Baseline|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
11205083|NCT02225860|BG001|Baseline|Control|Continue with usual diet
11205084|NCT02225860|BG002|Baseline|Total|Total of all reporting groups
11205085|NCT02225860|FG000|Participant Flow|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
11205086|NCT02225860|FG001|Participant Flow|Control|Continue with usual diet
11205087|NCT02225860|OG000|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
11205088|NCT02225860|OG001|Outcome|Control|Continue with usual diet
11205089|NCT02225860|OG000|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment: The dietary intervention consisted of three elements: low sodium (1500 mg/day), low protein (daily protein dietary allowance of 0.8 gram/kg body weight), and low urea (avoidance of preservatives, food additives, bulking agents, and chewing gum). Protein was factored by measured body weight to mirror the estimated average requirement (EAR) of healthy adults which is set on a grams per kilogram basis"
11205090|NCT02225860|EG000|Reported Event|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
11205091|NCT02225860|EG001|Reported Event|Control|Continue with usual diet
11205092|NCT02225925|BG000|Baseline|Dynamic Dosimetry Brachytherapy|Cohort treated with dynamic dosimetry brachytherapy
11205093|NCT02225925|FG000|Participant Flow|Dynamic Dosimetry Brachytherapy|Cohort treated with dynamic dosimetry brachytherapy
11205094|NCT02225925|OG000|Outcome|Dynamic Dosimetry Brachytherapy|Cohort treated with dynamic dosimetry brachytherapy
11205095|NCT02225925|EG000|Reported Event|Dynamic Dosimetry Brachytherapy|Cohort treated with dynamic dosimetry brachytherapy
11205096|NCT02226003|BG000|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
10806852|NCT02691013|OG000|Outcome|Placebo|"Patients will receive a Placebo tablet every evening.~Placebo"
10806853|NCT02691013|OG001|Outcome|Ramelteon|"Patients will receive Ramelteon 8mg every evening.~Ramelteon"
10806854|NCT02691013|EG000|Reported Event|Placebo|"Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total.~Placebo"
10806855|NCT02691013|EG001|Reported Event|Ramelteon|"Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total.~Ramelteon"
10806856|NCT02597062|BG000|Baseline|Carfilzomib Plus Cyclophosphamide Plus Dexamethasone|"20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg~Carfilzomib~Cyclophosphamide~Dexamethasone"
10806857|NCT02597062|FG000|Participant Flow|Carfilzomib Plus Cyclophosphamide Plus Dexamethasone|"20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg~Carfilzomib~Cyclophosphamide~Dexamethasone"
10806858|NCT02597062|OG000|Outcome|Carfilzomib Plus Cyclophosphamide Plus Dexamethasone|"20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg~Carfilzomib~Cyclophosphamide~Dexamethasone"
10806859|NCT02597062|EG000|Reported Event|Carfilzomib Plus Cyclophosphamide Plus Dexamethasone|"20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28 day cycle plus weekly oral dexamethasone (< 70 years, 40 mg; ≥ 70 years 20mg) and cyclophosphamide 300 mg/m2 capped at 500 mg~Carfilzomib~Cyclophosphamide~Dexamethasone"
10806860|NCT02130882|BG000|Baseline|Drug|"Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~benralizumab: An afucosylated humanized antibody to IL-5 receptor alpha"
10806861|NCT02130882|BG001|Baseline|Placebo|"Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~Placebo: A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline"
10806862|NCT02130882|BG002|Baseline|Total|Total of all reporting groups
11205097|NCT02226003|BG001|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
10806863|NCT02130882|FG000|Participant Flow|Drug|"Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~benralizumab: An afucosylated humanized antibody to IL-5 receptor alpha"
10806864|NCT02130882|FG001|Participant Flow|Placebo|"Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~Placebo: A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline"
10806865|NCT02130882|OG000|Outcome|Drug|"Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~benralizumab: An afucosylated humanized antibody to IL-5 receptor alpha"
10806866|NCT02130882|OG001|Outcome|Placebo|"Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~Placebo: A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline"
10806867|NCT02130882|EG000|Reported Event|Drug|"Benralizumab (30mg) will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~benralizumab: An afucosylated humanized antibody to IL-5 receptor alpha"
10806868|NCT02130882|EG001|Reported Event|Placebo|"Placebo will be administered sc every 4 weeks for 3 doses (at weeks 0, 4 and 8). Eosinophil counts will be blinded during this time and background HES therapy will not be tapered.~Placebo: A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline"
10806869|NCT01850563|BG000|Baseline|HBO Feasibility|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO. Demographic information (Race, gender, ethnicity, and age) were collected for only the participants who were prospectively enrolled and provided informed consent.
10806870|NCT01850563|BG001|Baseline|Historic Controls|Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
10806871|NCT01850563|BG002|Baseline|Total|Total of all reporting groups
10806872|NCT01850563|FG000|Participant Flow|HBO Feasibility|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
10806873|NCT01850563|FG001|Participant Flow|Historic Controls|Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
10806874|NCT01850563|OG000|Outcome|HBO Feasibility|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
10806875|NCT01850563|OG001|Outcome|Historic Controls|Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
10806876|NCT01850563|OG000|Outcome|HBO Feasibility|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO. Demographic information (Race, gender, ethnicity, and age) were collected for only the participants who were prospectively enrolled and provided informed consent. Demographic data was not collected for historic controls.
10806877|NCT01850563|EG000|Reported Event|HBO Feasibility|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
10806878|NCT01850563|EG001|Reported Event|Historic Controls|Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
10806879|NCT01827111|BG000|Baseline|ABI-007 + Ipilimumab|"Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.~ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.~Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.~Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes."
10806880|NCT01827111|FG000|Participant Flow|ABI-007 + Ipilimumab|"Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.~ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.~Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.~Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes."
10806881|NCT01827111|OG000|Outcome|ABI-007 + Ipilimumab|Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
10806882|NCT01827111|EG000|Reported Event|ABI-007 + Ipilimumab|Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
10806883|NCT01437111|BG000|Baseline|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
10806884|NCT01437111|FG000|Participant Flow|Fosamax Plus: All Participants|All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
10806885|NCT01437111|OG000|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
10806886|NCT01437111|OG001|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
10806887|NCT01437111|OG002|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
10806888|NCT01437111|OG003|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
10806889|NCT01437111|EG000|Reported Event|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
10806890|NCT01057121|BG000|Baseline|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806891|NCT01057121|BG001|Baseline|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806892|NCT01057121|BG002|Baseline|Total|Total of all reporting groups
10806893|NCT01057121|FG000|Participant Flow|Phase I: Treatment (Lenalidomide) , 10 mg/Day|Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10806894|NCT01057121|FG001|Participant Flow|Phase I: Treatment (Lenalidomide), 15 mg/Day|Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10806895|NCT01057121|FG002|Participant Flow|Phase I, Treatment Ienalidomide), 20 mg/Day|Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10806896|NCT01057121|FG003|Participant Flow|Phase I: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10806897|NCT01057121|FG004|Participant Flow|Phase II: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10806898|NCT01057121|OG000|Outcome|Phase I - Treatment (Lenalidomide)|"Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)"
10847573|NCT00283842|OG002|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10806899|NCT01057121|OG000|Outcome|Phase I - 10 mg/Day (Lenalidomide)|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806900|NCT01057121|OG001|Outcome|Phase I - 15 mg/Day (Lenalidomide)|"Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806901|NCT01057121|OG002|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806902|NCT01057121|OG003|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806903|NCT01057121|OG004|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806904|NCT01057121|OG000|Outcome|Phase I - 10 mg/Day Lenalidomide|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806905|NCT01057121|OG001|Outcome|Phase I - 15 mg/Day Lenalidomide|"Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806906|NCT01057121|OG000|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806907|NCT01057121|OG001|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806908|NCT01057121|OG002|Outcome|Phase I - 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806909|NCT01057121|OG003|Outcome|Phase I: Treatment (Lenalidomide), 25 mg/Day|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806910|NCT01057121|OG004|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806911|NCT01057121|OG000|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806912|NCT01057121|OG002|Outcome|Phase I: 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806913|NCT01057121|OG003|Outcome|Phase I: 25 mg/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806914|NCT01057121|OG000|Outcome|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806915|NCT01057121|OG001|Outcome|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806916|NCT01057121|EG000|Reported Event|Phase I: 10 mg/Day Lenalidomide|"Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806917|NCT01057121|EG001|Reported Event|Phase I: 15 mg/Day Lenalidomide|"Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806918|NCT01057121|EG002|Reported Event|Phase I: 20 mg/Day Lenalidomide|"Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806919|NCT01057121|EG003|Reported Event|Phase I and II: 25 mg/Day Lenalidomide|"Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
10806920|NCT01004263|BG000|Baseline|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
10806921|NCT01004263|FG000|Participant Flow|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
10806922|NCT01004263|OG000|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
10806923|NCT01004263|EG000|Reported Event|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
10806924|NCT01001234|BG000|Baseline|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
10806925|NCT01001234|BG001|Baseline|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
10806926|NCT01001234|BG002|Baseline|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
10806927|NCT01001234|BG003|Baseline|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
10806928|NCT01001234|BG004|Baseline|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
10806929|NCT01001234|BG005|Baseline|Total|Total of all reporting groups
10806930|NCT01001234|FG000|Participant Flow|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
10806931|NCT01001234|FG001|Participant Flow|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
10806932|NCT01001234|FG002|Participant Flow|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
10806933|NCT01001234|FG003|Participant Flow|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
10806934|NCT01001234|FG004|Participant Flow|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
11205098|NCT02226003|BG002|Baseline|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
11205099|NCT02226003|BG003|Baseline|Total|Total of all reporting groups
10806935|NCT01001234|OG000|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
10806936|NCT01001234|OG001|Outcome|Placebo|Participants randomized to placebo in Stage 2
10806937|NCT01001234|EG000|Reported Event|Rizatriptan|Participants who took any rizatriptan during the study (Stage 1 or 2)
10806938|NCT01001234|EG001|Reported Event|Placebo|Participants who took only placebo during the study
10806939|NCT00924170|BG000|Baseline|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
10806940|NCT00924170|BG001|Baseline|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
10806941|NCT00924170|BG002|Baseline|Total|Total of all reporting groups
10806942|NCT00924170|FG000|Participant Flow|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
10806943|NCT00924170|FG001|Participant Flow|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
10806944|NCT00924170|OG000|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
10806945|NCT00924170|OG001|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
10806946|NCT00924170|OG000|Outcome|Fludarabine and Cyclophosphamide: 20 + 200mg/m^2|Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg.
10806947|NCT00924170|OG001|Outcome|Fludarabine and Cyclophosphamide: 25 + 250mg/m^2|All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg.
10806948|NCT00924170|OG002|Outcome|Fludarabine and Cyclophosphamide: 30 + 300mg/m^2|Patients CF08 and CF09, both received LMB-2 40 µg/kg
10806949|NCT00924170|OG000|Outcome|Fludarabine and Cyclophosphamide: 20 + 200mg/m^2|Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg
10806950|NCT00924170|OG001|Outcome|Fludarabine and Cyclophosphamide: 25 + 250mg/m^2|All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg
10806951|NCT00924170|OG002|Outcome|3Fludarabine and Cyclophosphamide: 0 + 300mg/m^2|Patients CF08 and CF09, both received LMB-2 40 µg/kg
10806952|NCT00924170|EG000|Reported Event|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
10806953|NCT00924170|EG001|Reported Event|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
10806954|NCT00894556|BG000|Baseline|Rizatriptan / Rizatriptan / Placebo|The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
10806955|NCT00894556|BG001|Baseline|Rizatriptan / Placebo / Rizatriptan|The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
10806956|NCT00894556|BG002|Baseline|Placebo / Rizatriptan / Rizatriptan|The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
10806957|NCT00894556|BG003|Baseline|Total|Total of all reporting groups
10806958|NCT00894556|FG000|Participant Flow|Rizatriptan / Rizatriptan / Placebo|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo."
10806959|NCT00894556|FG001|Participant Flow|Rizatriptan / Placebo / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT."
10806960|NCT00894556|FG002|Participant Flow|Placebo / Rizatriptan / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT"
10806961|NCT00894556|FG003|Participant Flow|Sumatriptan 100 mg|Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
10806962|NCT00894556|OG000|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
10806963|NCT00894556|OG001|Outcome|Placebo|Migraines were treated with placebo
10806964|NCT00894556|EG000|Reported Event|Rizatriptan 10 mg|"Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).~Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.~Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently."
10806965|NCT00894556|EG001|Reported Event|Placebo|
10806966|NCT00894556|EG002|Reported Event|Sumatriptan 100 mg|"Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as Baseline Phase"
10806967|NCT00840177|BG000|Baseline|Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
10806968|NCT00840177|BG001|Baseline|Poor-risk Cohort: MDS Transformed to AML|Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
10806969|NCT00840177|BG002|Baseline|Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting < 6 months.
10806970|NCT00840177|BG003|Baseline|Total|Total of all reporting groups
10806971|NCT00840177|FG000|Participant Flow|Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
10806972|NCT00840177|FG001|Participant Flow|Poor-risk Cohort: MDS Transformed to AML|Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of myelodysplastic syndrome(MDS)/Chronic Myelomonocytic Leukemia (CMML) and for which they may have received previous non-intensive therapy.
10806973|NCT00840177|FG002|Participant Flow|Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting < 6 months.
11205100|NCT02226003|FG000|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
10806974|NCT00840177|OG000|Outcome|Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
10806975|NCT00840177|OG001|Outcome|Poor-risk Cohort: MDS Transformed to AML|Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
10806976|NCT00840177|OG002|Outcome|Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting < 6 months.
10806977|NCT00840177|EG000|Reported Event|Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
10806978|NCT00840177|EG001|Reported Event|Poor-risk Cohort: MDS Transformed to AML|Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
10806979|NCT00840177|EG002|Reported Event|Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission|Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting < 6 months.
10806980|NCT00820950|BG000|Baseline|Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream|Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
10806981|NCT00820950|BG001|Baseline|Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream|Ruxolitinib 1.0% cream vs. vehicle cream once a day for 28 days
10806982|NCT00820950|BG002|Baseline|Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream|Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
10806983|NCT00820950|BG003|Baseline|Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)|Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
10806984|NCT00820950|BG004|Baseline|Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)|Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
10806985|NCT00820950|BG005|Baseline|Total|Total of all reporting groups
10806986|NCT00820950|FG000|Participant Flow|Part 1 Cohort A: Vehicle Cream|Vehicle cream was applied once a day for 28 days
10806987|NCT00820950|FG001|Participant Flow|Part 1 Cohort A Ruxolitinib 0.5% Cream|Ruxolitinib 0.5% was applied once a day for 28 days
10806988|NCT00820950|FG002|Participant Flow|Part 1 Cohort B: Vehicle Cream|Vehicle Cream was applied once a day for 28 days
10806989|NCT00820950|FG003|Participant Flow|Part 1 Cohort B Ruxolitinib 1.0% Cream|Ruxolitinib 1.0% was applied once a day for 28 days
10806990|NCT00820950|FG004|Participant Flow|Part 1 Cohort C: Vehicle Cream|Vehicle Cream was applied once a day for 28 days
10806991|NCT00820950|FG005|Participant Flow|Part 1 Cohort C Ruxolitinib 1.5% Cream|Ruxolitinib 1.5% was applied once a day for 28 days
10806992|NCT00820950|FG006|Participant Flow|Part 2 Cohort D: INCB18424|up to 1/5% Ruolitinib cream was applied twice a day for 28 days
10806993|NCT00820950|FG007|Participant Flow|Part 2 Cohort D Calcipotriene (Dovonex®)|Calcipotriene (Dovonex®) 0.005% cream was applied twice a day for 28 days
10806994|NCT00820950|FG008|Participant Flow|Part 2 Cohort E: INCB18424|up to 1.5% Ruxolitinib cream was applied twice a day
10806995|NCT00820950|FG009|Participant Flow|Part 2 Cohort E Betamethasone Dipropionate (Diprolene® AF)|Betamethasone Dipropionate (Diprolene® AF) 0.05% cream were applied twice a day for 28 days
10806996|NCT00820950|OG000|Outcome|Part 1 Cohort A: Vehicle Cream|Vehicle cream was applied once a day for 28 days
10806997|NCT00820950|OG001|Outcome|Part 1 Cohort A: Ruxolitinib 0.5% Cream|Ruxolitinib 0.5% once a day for 28 days
10806998|NCT00820950|OG002|Outcome|Part 1 Cohort B: Vehicle Cream|Vehicle cream was applied once a day for 28 days
10806999|NCT00820950|OG003|Outcome|Part 1 Cohort B: Ruxolitinib 1.0% Cream|Ruxolitinib 1.0% cream once a day for 28 days
10807000|NCT00820950|OG004|Outcome|Part 1 Cohort C: Vehicle Cream|Vehicle cream was applied twice a day for 28 days
10807001|NCT00820950|OG005|Outcome|Part 1 Cohort C: Ruxolitinib 1.5% Cream|Ruxolitinib 1.5% twice a day for 28 days
10807002|NCT00820950|OG006|Outcome|Part 2 Cohort D: INCB18424|up to 1.5% Ruxolitinib cream was applied twice a day
10807003|NCT00820950|OG007|Outcome|Part 2 Cohort D: Calcipotriene (Dovonex®)|Calcipotriene (Dovonex®) 0.005% cream was applied twice a day
10807004|NCT00820950|OG008|Outcome|Part 2 Cohort E: INCB18424|up to 1.5% Ruxolitinib cream was applied twice a day
10807005|NCT00820950|OG009|Outcome|Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF)|Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days
10807006|NCT00820950|OG000|Outcome|Part 1 Cohort A: Vehicle|placebo cream
10807007|NCT00820950|OG001|Outcome|Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream|Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
10807008|NCT00820950|OG002|Outcome|Part 1 Cohort B: Vehicle|Placebo cream
10807009|NCT00820950|OG003|Outcome|Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream|Ruxolitinib 1.0% cream once a day for 28 days
10807010|NCT00820950|OG004|Outcome|Part 1 Cohort C: Vehicle Cream|Vehicle Placebo cream
10807011|NCT00820950|OG005|Outcome|Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream|Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
10807012|NCT00820950|OG006|Outcome|Part 2 Cohort D: INCB18424|up to 1.5% Ruxolitinib
10807013|NCT00820950|OG007|Outcome|Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)|Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
10807014|NCT00820950|OG008|Outcome|Part 2 Cohort E: INCB18424|up to 1.5% Ruxolitinib cream
10807015|NCT00820950|OG009|Outcome|Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)|Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
10807016|NCT00820950|OG000|Outcome|Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream|Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
10807017|NCT00820950|OG001|Outcome|Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle|Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
10807018|NCT00820950|OG002|Outcome|Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream|Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
10807019|NCT00820950|OG003|Outcome|Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)|Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
10807020|NCT00820950|OG004|Outcome|Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)|Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
10807021|NCT00820950|OG001|Outcome|Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle|Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
10807022|NCT00820950|OG000|Outcome|Cohort A: Vehicle|Placebo cream
10807023|NCT00820950|OG002|Outcome|Cohort B: Vehicle|Placebo cream
11205101|NCT02226003|FG001|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
10807024|NCT00820950|OG003|Outcome|Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle|Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
10807025|NCT00820950|OG004|Outcome|Cohort C: Vehicle|Placebo cream
10807026|NCT00820950|OG006|Outcome|Cohort D: INCB18424|Ruxolitinb to 1.5%
10807027|NCT00820950|OG008|Outcome|Cohort E: INCB18424|Ruxolitinib up to 1.5%
10807028|NCT00820950|EG000|Reported Event|Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream|Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
10807029|NCT00820950|EG001|Reported Event|Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream|Ruxolitinib 1.0% cream once a day for 28 days
10807030|NCT00820950|EG002|Reported Event|Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream|Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
10807031|NCT00820950|EG003|Reported Event|Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)|Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
10807032|NCT00820950|EG004|Reported Event|Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)|Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
10807033|NCT00820950|EG005|Reported Event|Total|Total
10807034|NCT00806416|BG000|Baseline|Part I|70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
10807035|NCT00806416|BG001|Baseline|Part II|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
10807036|NCT00806416|BG002|Baseline|Total|Total of all reporting groups
10807037|NCT00806416|FG000|Participant Flow|Alendronate/Vitamin D Combination Then Alendronate|70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
10807038|NCT00806416|FG001|Participant Flow|Alendronate Then Alendronate/Vitamin D Combination|70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
10807039|NCT00806416|FG002|Participant Flow|Alendronate/Vitamin D Combination Then Vitamin D|70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
10807040|NCT00806416|FG003|Participant Flow|Vitamin D Then Alendronate/Vitamin D Combination|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
10807041|NCT00806416|OG000|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
10807042|NCT00806416|OG001|Outcome|Alendronate|70 mg alendronate tablet
10807043|NCT00806416|OG001|Outcome|Vitamin D|2800-IU vitamin D3 tablet
10807044|NCT00806416|EG000|Reported Event|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
10807045|NCT00806416|EG001|Reported Event|Alendronate|70 mg alendronate tablet
10807046|NCT00806416|EG002|Reported Event|Vitamin D|2800-IU vitamin D3 tablet
10807047|NCT00729651|BG000|Baseline|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
10807048|NCT00729651|BG001|Baseline|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
10807049|NCT00729651|BG002|Baseline|Total|Total of all reporting groups
10807050|NCT00729651|FG000|Participant Flow|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
10807051|NCT00729651|FG001|Participant Flow|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
10807052|NCT00729651|OG000|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
10807053|NCT00729651|OG001|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
10807054|NCT00729651|EG000|Reported Event|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
10807055|NCT00729651|EG001|Reported Event|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
10807056|NCT00698815|BG000|Baseline|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
10807057|NCT00698815|BG001|Baseline|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
10807058|NCT00698815|BG002|Baseline|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
10807059|NCT00698815|BG003|Baseline|Total|Total of all reporting groups
10807060|NCT00698815|FG000|Participant Flow|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
10807061|NCT00698815|FG001|Participant Flow|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
10807062|NCT00698815|FG002|Participant Flow|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
10807063|NCT00698815|OG000|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
10807064|NCT00698815|OG001|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
10807065|NCT00698815|OG002|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
10807066|NCT00698815|EG000|Reported Event|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
10807067|NCT00698815|EG001|Reported Event|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
10807068|NCT00698815|EG002|Reported Event|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
10807069|NCT00698022|BG000|Baseline|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
10807070|NCT00698022|BG001|Baseline|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
10807071|NCT00698022|BG002|Baseline|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
10807072|NCT00698022|BG003|Baseline|Total|Total of all reporting groups
10807073|NCT00698022|FG000|Participant Flow|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
10807074|NCT00698022|FG001|Participant Flow|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
10807075|NCT00698022|FG002|Participant Flow|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
10807076|NCT00698022|OG000|Outcome|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
10807077|NCT00698022|OG001|Outcome|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
10807078|NCT00698022|OG002|Outcome|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
10807079|NCT00698022|EG000|Reported Event|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
10807080|NCT00698022|EG001|Reported Event|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
10807081|NCT00698022|EG002|Reported Event|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
10807082|NCT00692913|BG000|Baseline|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
10807083|NCT00692913|BG001|Baseline|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
10807084|NCT00692913|BG002|Baseline|Total|Total of all reporting groups
10807085|NCT00692913|FG000|Participant Flow|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
10807086|NCT00692913|FG001|Participant Flow|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
10807087|NCT00692913|OG000|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
10807088|NCT00692913|OG001|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
10807089|NCT00692913|EG000|Reported Event|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
10807090|NCT00692913|EG001|Reported Event|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
10807091|NCT00617994|BG000|Baseline|Cohort A|2% to 7% of BSA treated BID with INCB018424 1.5% cream
10807092|NCT00617994|BG001|Baseline|Cohort B|8% to 13% of BSA treated BID with INCB018424 1.5% cream
10807093|NCT00617994|BG002|Baseline|Cohort C|14% to 20% of BSA treated QD with INCB018424 1.5% cream
10807094|NCT00617994|BG003|Baseline|Cohort D|14% to 20% of BSA treated BID with INCB018424 1.0% cream
10807095|NCT00617994|BG004|Baseline|Cohort E|14% to 20% of BSA treated BID with INCB018424 1.5% cream
10807096|NCT00617994|BG005|Baseline|Total|Total of all reporting groups
10807097|NCT00617994|FG000|Participant Flow|Cohort A|2% to 7% of BSA treated BID with INCB018424 1.5% cream
10807098|NCT00617994|FG001|Participant Flow|Cohort B|8% to 13% of BSA treated BID with INCB018424 1.5% cream
10807099|NCT00617994|FG002|Participant Flow|Cohort C|14% to 20% of BSA treated QD with INCB018424 1.5% cream
10807100|NCT00617994|FG003|Participant Flow|Cohort D|14% to 20% of BSA treated BID with INCB018424 1.0% cream
10807101|NCT00617994|FG004|Participant Flow|Cohort E|14% to 20% of BSA treated BID with INCB018424 1.5% cream
10807102|NCT00617994|OG000|Outcome|Cohort A|2% to 7% of BSA treated BID with INCB018424 1.5% cream
10807103|NCT00617994|OG001|Outcome|Cohort B|8% to 13% of BSA treated BID with INCB018424 1.5% cream
10807104|NCT00617994|OG002|Outcome|Cohort C|14% to 20% of BSA treated QD with INCB018424 1.5% cream
10807105|NCT00617994|OG003|Outcome|Cohort D|14% to 20% of BSA treated BID with INCB018424 1.0% cream
10807106|NCT00617994|OG004|Outcome|Cohort E|14% to 20% of BSA treated BID with INCB018424 1.5% cream
10807107|NCT00617994|OG000|Outcome|Cohort A: Control Lesion|Control Lesions were not treated.
11205102|NCT02226003|FG002|Participant Flow|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
11244246|NCT02509481|BG001|Baseline|Repeated MDA|"Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.~Ivermectin~Albendazole"
10807108|NCT00617994|OG001|Outcome|Cohort A|2% to 7% of BSA treated BID with INCB018424 1.5% cream
10807109|NCT00617994|OG002|Outcome|Cohort B: Control Lesion|Control Lesions were not treated.
10807110|NCT00617994|OG003|Outcome|Cohort B|8% to 13% of BSA treated BID with INCB018424 1.5% cream
10807111|NCT00617994|OG004|Outcome|Cohort C: Control Lesion|Control Lesions were not treated.
10807112|NCT00617994|OG005|Outcome|Cohort C|14% to 20% of BSA treated QD with INCB018424 1.5% cream
10807113|NCT00617994|OG006|Outcome|Cohort D: Control Lesion|Control Lesions were not treated.
10807114|NCT00617994|OG007|Outcome|Cohort D|14% to 20% of BSA treated BID with INCB018424 1.0% cream
10807115|NCT00617994|OG008|Outcome|Cohort E: Control Lesion|Control Lesions were not treated.
10807116|NCT00617994|OG009|Outcome|Cohort E|14% to 20% of BSA treated BID with INCB018424 1.5% cream
10807117|NCT00617994|OG000|Outcome|Cohort A: Control Lesion|Control lesions were not treated.
10807118|NCT00617994|OG002|Outcome|Cohort B: Control Lesion|Control lesions were not treated.
10807119|NCT00617994|OG004|Outcome|Cohort C: Control Lesion|Control lesions were not treated.
10807120|NCT00617994|OG006|Outcome|Cohort D: Control Lesion|Control lesions were untreated.
10807121|NCT00617994|OG008|Outcome|Control E: Control Lesion|Control Lesions were untreated.
10807122|NCT00617994|EG000|Reported Event|Cohort A|2 to 7% of BSA treated BID with INCB018424 1.5% cream
10807123|NCT00617994|EG001|Reported Event|Cohort B|8 to 13% of BSA treated BID with INCB018424 1.5% cream BID
10807124|NCT00617994|EG002|Reported Event|Cohort C|14 to 20% of BSA treated QD with INCB018424 1.5% cream QD
10807125|NCT00617994|EG003|Reported Event|Cohort D|14-20% of BSA with INCB018424 1.0% cream BID
10807126|NCT00617994|EG004|Reported Event|Cohort E|14 to 20% of BSA treated BID with INCB018424 1.5% cream BID
10807127|NCT00617994|EG005|Reported Event|Total|Total
10807128|NCT00617708|BG000|Baseline|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807129|NCT00617708|BG001|Baseline|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807130|NCT00617708|BG002|Baseline|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
10807131|NCT00617708|BG003|Baseline|Total|Total of all reporting groups
10807132|NCT00617708|FG000|Participant Flow|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807133|NCT00617708|FG001|Participant Flow|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807134|NCT00617708|FG002|Participant Flow|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
10807135|NCT00617708|OG000|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807136|NCT00617708|OG001|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
10807137|NCT00617708|OG000|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807138|NCT00617708|OG001|Outcome|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807139|NCT00617708|OG002|Outcome|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
10807140|NCT00617708|EG000|Reported Event|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807141|NCT00617708|EG001|Reported Event|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
10807142|NCT00617708|EG002|Reported Event|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
10807143|NCT00516737|BG000|Baseline|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
10807144|NCT00516737|BG001|Baseline|Placebo|Matching placebo; one dose, treatment of a single migraine attack
10807145|NCT00516737|BG002|Baseline|Total|Total of all reporting groups
10807146|NCT00516737|FG000|Participant Flow|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
10807147|NCT00516737|FG001|Participant Flow|Placebo|Matching placebo; one dose, treatment of a single migraine attack
11205103|NCT02226003|OG000|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
10807148|NCT00516737|OG000|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
10807149|NCT00516737|OG001|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
10807150|NCT00516737|EG000|Reported Event|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
10807151|NCT00516737|EG001|Reported Event|Placebo|Matching placebo; one dose, treatment of a single migraine attack
10807152|NCT00358527|BG000|Baseline|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
10807153|NCT00358527|BG001|Baseline|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
10807154|NCT00358527|BG002|Baseline|Total|Total of all reporting groups
10807155|NCT00358527|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
10807156|NCT00358527|FG001|Participant Flow|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
10807157|NCT00358527|OG000|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
10807158|NCT00358527|OG001|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
10807159|NCT00358527|EG000|Reported Event|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
10807160|NCT00358527|EG001|Reported Event|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
10807161|NCT00326898|BG000|Baseline|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
10807162|NCT00326898|BG001|Baseline|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
10807163|NCT00326898|BG002|Baseline|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
10807164|NCT00326898|BG003|Baseline|Total|Total of all reporting groups
10807165|NCT00326898|FG000|Participant Flow|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
10807166|NCT00326898|FG001|Participant Flow|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
10847574|NCT00283842|OG003|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11205104|NCT02226003|OG001|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
10807167|NCT00326898|FG002|Participant Flow|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
10807168|NCT00326898|OG000|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
10807169|NCT00326898|OG001|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
10807170|NCT00326898|OG002|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
10807171|NCT00326898|EG000|Reported Event|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
10807172|NCT00326898|EG001|Reported Event|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
10807173|NCT00326898|EG002|Reported Event|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
10807174|NCT00156065|BG000|Baseline|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
10807175|NCT00156065|BG001|Baseline|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
10807176|NCT00156065|BG002|Baseline|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
10807177|NCT00156065|BG003|Baseline|Total|Total of all reporting groups
10807178|NCT00156065|FG000|Participant Flow|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
10807179|NCT00156065|FG001|Participant Flow|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
10807180|NCT00156065|FG002|Participant Flow|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
10807181|NCT00156065|OG000|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
10807182|NCT00156065|OG001|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
10807183|NCT00156065|OG002|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
10807184|NCT00156065|EG000|Reported Event|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
10807185|NCT00156065|EG001|Reported Event|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
10807186|NCT00156065|EG002|Reported Event|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
10807187|NCT00150176|BG000|Baseline|Asenapine|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
10807188|NCT00150176|BG001|Baseline|Placebo|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
10807189|NCT00150176|BG002|Baseline|Total|Total of all reporting groups
10807190|NCT00150176|FG000|Participant Flow|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
10807191|NCT00150176|FG001|Participant Flow|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
10807192|NCT00150176|OG000|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
10807193|NCT00150176|OG001|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
10807194|NCT00150176|EG000|Reported Event|Asenapine|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
10807195|NCT00150176|EG001|Reported Event|Placebo|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
10807196|NCT00150176|EG002|Reported Event|Asenapine During Open-Label Phase and Not Randomized|Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
10807197|NCT00145509|BG000|Baseline|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
10807198|NCT00145509|BG001|Baseline|Placebo|Placebo sublingually BID
10807199|NCT00145509|BG002|Baseline|Total|Total of all reporting groups
10847575|NCT00283842|OG004|Outcome|Placebo|
10807200|NCT00145509|FG000|Participant Flow|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
10807201|NCT00145509|FG001|Participant Flow|Placebo|Placebo sublingually BID
10807202|NCT00145509|OG000|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
10807203|NCT00145509|OG001|Outcome|Placebo|Placebo sublingually BID
10807204|NCT00145509|EG000|Reported Event|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
10807205|NCT00145509|EG001|Reported Event|Placebo|Placebo sublingually BID
10807206|NCT00145496|BG000|Baseline|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
11205105|NCT02226003|OG002|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
10807207|NCT00145496|BG001|Baseline|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
10807208|NCT00145496|BG002|Baseline|Total|Total of all reporting groups
11205106|NCT02226003|EG000|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
11244247|NCT02509481|BG002|Baseline|Total|Total of all reporting groups
10807209|NCT00145496|FG000|Participant Flow|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
11244248|NCT02509481|FG000|Participant Flow|Single MDA|"Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.~Ivermectin~Albendazole"
11244249|NCT02509481|FG001|Participant Flow|Repeated MDA|"Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.~Ivermectin~Albendazole"
11244250|NCT02509481|OG000|Outcome|Single MDA|"Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.~Ivermectin~Albendazole"
11244251|NCT02509481|OG001|Outcome|Repeated MDA|"Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.~Ivermectin~Albendazole"
11244252|NCT02509481|EG000|Reported Event|Single MDA|"Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.~Ivermectin~Albendazole"
11244253|NCT02509481|EG001|Reported Event|Repeated MDA|"Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.~Ivermectin~Albendazole"
11244254|NCT02509585|BG000|Baseline|Tc99m Tilmanocept|Enrolled subjects who were administered any injection of Tc99m tilmanocept.
11244255|NCT02509585|FG000|Participant Flow|Tc99m Tilmanocept|"2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration~Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery"
11244256|NCT02509585|OG000|Outcome|Intent-To-Treat|"2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration~Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery"
11244257|NCT02509585|OG000|Outcome|Tc99m Tilmanocept|Enrolled patients who were administered any injection of Lymphoseek.
11244258|NCT02509585|EG000|Reported Event|Tc99m Tilmanocept|Enrolled subjects who were administered any injection of Tc99m tilmanocept.
11244259|NCT02509624|BG000|Baseline|Cohort 1: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244260|NCT02509624|BG001|Baseline|Cohort 2: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244261|NCT02509624|BG002|Baseline|Cohort 3: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244262|NCT02509624|BG003|Baseline|Healthy Control|Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244263|NCT02509624|BG004|Baseline|Total|Total of all reporting groups
11244264|NCT02509624|FG000|Participant Flow|Cohort 1: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244265|NCT02509624|FG001|Participant Flow|Cohort 2: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244266|NCT02509624|FG002|Participant Flow|Cohort 3: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244267|NCT02509624|FG003|Participant Flow|Healthy Control|Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244268|NCT02509624|OG000|Outcome|Cohort 1: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244269|NCT02509624|OG001|Outcome|Cohort 2: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244270|NCT02509624|OG002|Outcome|Cohort 3: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244271|NCT02509624|OG003|Outcome|Matched Healthy Control for Cohort 1|Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244272|NCT02509624|OG004|Outcome|Matched Healthy Control for Cohort 2|Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244273|NCT02509624|OG005|Outcome|Matched Healthy Control for Cohort 3|Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244274|NCT02509624|OG003|Outcome|Healthy Control|Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244275|NCT02509624|EG000|Reported Event|Cohort 1: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244276|NCT02509624|EG001|Reported Event|Cohort 2: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244277|NCT02509624|EG002|Reported Event|Cohort 3: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11244278|NCT02509624|EG003|Reported Event|Healthy Control|Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
11286158|NCT02884492|BG000|Baseline|Cognitive Impairment|"Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
10807210|NCT00145496|FG001|Participant Flow|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
10807211|NCT00145496|OG000|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
10807212|NCT00145496|OG001|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
10807213|NCT00145496|EG000|Reported Event|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
10807214|NCT00145496|EG001|Reported Event|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
10820706|NCT00061893|EG000|Reported Event|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
10820707|NCT00061932|BG000|Baseline|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
10820708|NCT00061932|BG001|Baseline|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
10820709|NCT00061932|BG002|Baseline|Total|Total of all reporting groups
10820710|NCT00061932|FG000|Participant Flow|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.~bortezomib: Given IV (1.3 mg/m2)~irinotecan: Given IV (125 mg/m2)"
10820711|NCT00061932|FG001|Participant Flow|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
10820712|NCT00061932|OG000|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
10820713|NCT00061932|OG001|Outcome|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
10820714|NCT00061932|OG000|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.~bortezomib: Given IV (1.3 mg/m2)~irinotecan: Given IV (125 mg/m2)"
10820715|NCT00061932|EG000|Reported Event|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
10820716|NCT00061932|EG001|Reported Event|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
10820717|NCT00062010|BG000|Baseline|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
10820718|NCT00062010|FG000|Participant Flow|IFN Alpha, 13-Cis-RA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
10820719|NCT00062010|OG000|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
10820720|NCT00062010|EG000|Reported Event|IFN Alpha, 13-CRA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
10820721|NCT00062166|BG000|Baseline|Von Hippel Lindau|Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population.
10820722|NCT00062166|FG000|Participant Flow|Von Hippel Lindau|Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population.
10820723|NCT00062166|OG000|Outcome|Von Hippel Lindau|Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population.
10820724|NCT00062166|OG000|Outcome|Von Hippel Lindau|Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. These tumors are Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population.
10820725|NCT00062166|EG000|Reported Event|Von Hippel Lindau|Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population.
10847576|NCT00283842|EG000|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847577|NCT00283842|EG001|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847578|NCT00283842|EG002|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
11205107|NCT02226003|EG001|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
11205108|NCT02226003|EG002|Reported Event|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
11205109|NCT02226120|BG000|Baseline|LCZ696|Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
11205110|NCT02226120|FG000|Participant Flow|LCZ696|Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
11205111|NCT02226120|OG000|Outcome|LCZ696|Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
11205112|NCT02226120|EG000|Reported Event|LCZ696|Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
11205113|NCT02226159|BG000|Baseline|Lidocaine|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline~Lidocaine"
11205114|NCT02226159|BG001|Baseline|Lidocaine With Dexamethasone|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)~Lidocaine with Dexamethasone"
11205115|NCT02226159|BG002|Baseline|Total|Total of all reporting groups
11205116|NCT02226159|FG000|Participant Flow|Lidocaine|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline~Lidocaine"
11205117|NCT02226159|FG001|Participant Flow|Lidocaine With Dexamethasone|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)~Lidocaine with Dexamethasone"
11205118|NCT02226159|OG000|Outcome|Lidocaine|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline~Lidocaine"
11205119|NCT02226159|OG001|Outcome|Lidocaine With Dexamethasone|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)~Lidocaine with Dexamethasone"
11205120|NCT02226159|EG000|Reported Event|Lidocaine|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline~Lidocaine"
11205121|NCT02226159|EG001|Reported Event|Lidocaine With Dexamethasone|"Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)~Lidocaine with Dexamethasone"
11205122|NCT02226172|BG000|Baseline|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
11205123|NCT02226172|FG000|Participant Flow|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
11205124|NCT02226172|OG000|Outcome|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
11205125|NCT02226172|EG000|Reported Event|Glasdegib Lead-in|Glasdegib administered orally at a daily starting dose of 100 mg on a continuous regimen of 28-day cycles.
11205126|NCT02226198|BG000|Baseline|Cross-over|Cross-over phase
11205127|NCT02226198|FG000|Participant Flow|Overall|Relevant for the lead-in and maintenance phases
11205128|NCT02226198|FG001|Participant Flow|Rosuva First Then Placebo|Relevant for the cross-over phase
11205129|NCT02226198|FG002|Participant Flow|Placebo First Then Rosuva|Relevant for the cross-over phase
11205130|NCT02226198|OG000|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
11205131|NCT02226198|OG001|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
11205132|NCT02226198|OG001|Outcome|C-FAS Placebo Not on Apheresis|Cross-over Full Analysis Set, 6 weeks of Placebo
11205133|NCT02226198|OG000|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
11205134|NCT02226198|OG001|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
11205135|NCT02226198|OG000|Outcome|Cross-over Phase|Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
11205136|NCT02226198|OG001|Outcome|Maintenance Phase|Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
11205137|NCT02226198|OG000|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
11205138|NCT02226198|OG001|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
11205139|NCT02226198|OG002|Outcome|Maintenance|Maintenance Phase, Safety analysis set
11205140|NCT02226198|OG002|Outcome|Maintenance Phase|Maintenance phase, Safety analysis set
11205141|NCT02226198|OG000|Outcome|Ros/Pla <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
11205142|NCT02226198|OG001|Outcome|Ros/Pla >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
11205143|NCT02226198|OG002|Outcome|Pla/Ros <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
11205144|NCT02226198|OG003|Outcome|Pla/Ros >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
11205145|NCT02226198|OG000|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
11205146|NCT02226198|OG001|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
11205147|NCT02226198|OG000|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
11205148|NCT02226198|OG000|Outcome|Safety Analysis Set|Safety Analysis Set
11205149|NCT02226198|OG001|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
11205150|NCT02226198|OG002|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
11205151|NCT02226198|EG000|Reported Event|Lead-in|Lead-in
11205152|NCT02226198|EG001|Reported Event|Cross-over|Cross-over phase
11205153|NCT02226198|EG002|Reported Event|Maintenance|Maintenance phase
11205154|NCT02226549|BG000|Baseline|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
11205155|NCT02226549|BG001|Baseline|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11205156|NCT02226549|BG002|Baseline|Total|Total of all reporting groups
11205157|NCT02226549|FG000|Participant Flow|LDV/SOF+VDV|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
10807215|NCT00145470|BG000|Baseline|Placebo|Participants received placebo on Days 1-84 as a fast-dissolving sublingual (SL) tablet, given twice daily (BID).
10807216|NCT00145470|BG001|Baseline|Asenapine|Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
10807217|NCT00145470|BG002|Baseline|Total|Total of all reporting groups
10807218|NCT00145470|FG000|Participant Flow|Placebo|Participants received placebo on Days 1-84 as a fast-dissolving sublingual (SL) tablet, given twice daily (BID).
10807219|NCT00145470|FG001|Participant Flow|Asenapine|Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
10807220|NCT00145470|OG000|Outcome|Placebo|Participants received placebo on Days 1-84 as a fast-dissolving sublingual (SL) tablet, given twice daily (BID).
10807221|NCT00145470|OG001|Outcome|Asenapine|Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
10807222|NCT00145470|EG000|Reported Event|Placebo|Participants received placebo on Days 1-84 as a fast-dissolving sublingual (SL) tablet, given twice daily (BID).
10807223|NCT00145470|EG001|Reported Event|Asenapine|Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
10807224|NCT00129402|BG000|Baseline|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
10807225|NCT00129402|BG001|Baseline|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
10807226|NCT00129402|BG002|Baseline|Total|Total of all reporting groups
10807227|NCT00129402|FG000|Participant Flow|Ezetimibe/Simvastatin 10/10|Subjects who received ezetimibe 10 mg plus simvastatin 10 mg once daily
10807228|NCT00129402|FG001|Participant Flow|Ezetimibe/Simvastatin 10/20|Subjects who received ezetimibe 10 mg with simvastatin 10 mg once daily
10807229|NCT00129402|FG002|Participant Flow|Ezetimibe/Simvastatin 10/40|Subjects who received ezetimibe 10 mg plus simvastatin 40 mg once daily
11205158|NCT02226549|FG001|Participant Flow|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11205159|NCT02226549|OG000|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
10807230|NCT00129402|FG003|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 10|Subjects who received simvastatin monotherapy 10 mg once daily
10807231|NCT00129402|FG004|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 20|Subjects who received simvastatin monotherapy 20 mg once daily
10807232|NCT00129402|FG005|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 40|Subjects who received simvastatin monotherapy 40 mg once daily
10807233|NCT00129402|FG006|Participant Flow|Long-term Experience Ezetimbe/Simvastatin|Subjects who received long-term coadministration of ezetimibe with simvastatin once daily
10807234|NCT00129402|OG000|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
10807235|NCT00129402|OG001|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
10807236|NCT00129402|OG001|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|pooled subjects who received simvastatin 10 mg monotherapy, simvastatin 20 mg monotherapy, or simvastatin 40 mg monotherapy
10807237|NCT00129402|EG000|Reported Event|Ezetimibe With Simvastatin|Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2
10807238|NCT00129402|EG001|Reported Event|Simvastatin Monotherapy|"Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment~groups during Period 1 and Period 2."
10807239|NCT00129402|EG002|Reported Event|Long-term Coadministration of Ezetimibe With Simvastatin|"Column 3 provides the combined AE data collected for~all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis."
10807240|NCT00101439|BG000|Baseline|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
10807241|NCT00101439|BG001|Baseline|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
10807242|NCT00101439|BG002|Baseline|Total|Total of all reporting groups
10807243|NCT00101439|FG000|Participant Flow|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
10807244|NCT00101439|FG001|Participant Flow|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
10807245|NCT00101439|OG000|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
10807246|NCT00101439|OG001|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
11205160|NCT02226549|OG001|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
11205161|NCT02226549|EG000|Reported Event|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
11205162|NCT02226549|EG001|Reported Event|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
10807247|NCT00101439|EG000|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe once daily for 4 weeks
10807248|NCT00101439|EG001|Reported Event|Placebo|Participants received placebo once daily for 4 weeks
10807249|NCT00096200|BG000|Baseline|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
10807250|NCT00096200|BG001|Baseline|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10807251|NCT00096200|BG002|Baseline|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
10807252|NCT00096200|BG003|Baseline|Total|Total of all reporting groups
10807253|NCT00096200|FG000|Participant Flow|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
10807254|NCT00096200|FG001|Participant Flow|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10807255|NCT00096200|FG002|Participant Flow|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
10807256|NCT00096200|OG000|Outcome|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
10807257|NCT00096200|OG001|Outcome|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10807258|NCT00096200|OG002|Outcome|Arm C: Crossover From Arm A to B|Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10807259|NCT00096200|EG000|Reported Event|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
10807260|NCT00096200|EG001|Reported Event|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10807261|NCT00096200|EG002|Reported Event|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
10820726|NCT00062374|BG000|Baseline|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
10820727|NCT00062374|FG000|Participant Flow|Arm I|Cisplatin + Irinotecan
10820728|NCT00062374|OG000|Outcome|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
10820729|NCT00062374|EG000|Reported Event|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
10820730|NCT00062439|BG000|Baseline|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
10820731|NCT00062439|FG000|Participant Flow|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
10820732|NCT00062439|OG000|Outcome|Induction Cisplatin/Etoposide + XRT|
10820733|NCT00062439|OG001|Outcome|Surgery|
10820734|NCT00062439|OG002|Outcome|Consolidation Docetaxel|
10820735|NCT00062439|OG000|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
10820736|NCT00062439|EG000|Reported Event|Induction Cisplatin/Etoposide + XRT|
10820737|NCT00062439|EG001|Reported Event|Surgery|
10820738|NCT00062439|EG002|Reported Event|Consolidation Docetaxel|
10807262|NCT03257267|BG000|Baseline|Cemiplimab|Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807263|NCT03257267|BG001|Baseline|Investigator Choice (IC) Chemotherapy|Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807264|NCT03257267|BG002|Baseline|Total|Total of all reporting groups
10807265|NCT03257267|FG000|Participant Flow|Cemiplimab|Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807266|NCT03257267|FG001|Participant Flow|Investigator Choice (IC) Chemotherapy|Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807267|NCT03257267|OG000|Outcome|Cemiplimab|Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807268|NCT03257267|OG001|Outcome|Investigator Choice (IC) Chemotherapy|Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807269|NCT03257267|EG000|Reported Event|Cemiplimab|Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807270|NCT03257267|EG001|Reported Event|Investigator Choice (IC) Chemotherapy|Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
10807271|NCT04581811|BG000|Baseline|Prolonged Proning Arm|"Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study~Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period"
10807272|NCT04581811|BG001|Baseline|Traditional Proning Arm|"Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study~Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period"
10807273|NCT04581811|BG002|Baseline|Total|Total of all reporting groups
10807274|NCT04581811|FG000|Participant Flow|Prolonged Proning Arm|"Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study~Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period"
10807275|NCT04581811|FG001|Participant Flow|Traditional Proning Arm|"Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study~Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period"
10807276|NCT04581811|OG000|Outcome|Prolonged Proning Arm|Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study
10807277|NCT04581811|OG001|Outcome|Traditional Proning Arm|Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
10807278|NCT04581811|EG000|Reported Event|Prolonged Proning Arm|Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study
10807279|NCT04581811|EG001|Reported Event|Traditional Proning Arm|Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
11205163|NCT02226562|BG000|Baseline|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
11205164|NCT02226562|BG001|Baseline|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
11205165|NCT02226562|BG002|Baseline|Total|Total of all reporting groups
11205166|NCT02226562|FG000|Participant Flow|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
11205167|NCT02226562|FG001|Participant Flow|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
10807280|NCT04456959|BG000|Baseline|Inotuzumab Ozogamicin (InO)|Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
10807281|NCT04456959|FG000|Participant Flow|Inotuzumab Ozogamicin (InO)|Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
10807282|NCT04456959|OG000|Outcome|Inotuzumab Ozogamicin (InO)|Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
10807283|NCT04456959|EG000|Reported Event|Inotuzumab Ozogamicin (InO)|Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
10820739|NCT00062647|BG000|Baseline|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
10820740|NCT00062647|BG001|Baseline|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
10820741|NCT00062647|BG002|Baseline|Total|Total of all reporting groups
10820742|NCT00062647|FG000|Participant Flow|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
10820743|NCT00062647|FG001|Participant Flow|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
10820744|NCT00062647|OG000|Outcome|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
10820745|NCT00062647|OG001|Outcome|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
10820746|NCT00062647|EG000|Reported Event|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
10820747|NCT00062647|EG001|Reported Event|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
10820748|NCT00062738|BG000|Baseline|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
10820749|NCT00062738|BG001|Baseline|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
10820750|NCT00062738|BG002|Baseline|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
10820751|NCT00062738|BG003|Baseline|Total|Total of all reporting groups
10820752|NCT00062738|FG000|Participant Flow|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
10820753|NCT00062738|FG001|Participant Flow|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
10820754|NCT00062738|FG002|Participant Flow|Placebo|Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
10820755|NCT00062738|OG000|Outcome|Nortriptyline|
10820756|NCT00062738|OG001|Outcome|Paroxetine|
10820757|NCT00062738|OG002|Outcome|Placebo|
10820758|NCT00062738|OG000|Outcome|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
10820759|NCT00062738|OG001|Outcome|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
10820760|NCT00062738|OG002|Outcome|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
10820761|NCT00062738|EG000|Reported Event|Nortriptyline|
10820762|NCT00062738|EG001|Reported Event|Paroxetine|
10820763|NCT00062738|EG002|Reported Event|Placebo|
10820764|NCT00062764|BG000|Baseline|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
10820765|NCT00062764|FG000|Participant Flow|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
10820766|NCT00062764|OG000|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
10820767|NCT00062764|EG000|Reported Event|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
10807284|NCT04263987|BG000|Baseline|Holmium Laser Enucleation of Prostate|"Traditional holmium laser enucleation of the prostate as currently performed~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807285|NCT04263987|BG001|Baseline|Moses Holmium Laser Enucleation of Prostate|"holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807286|NCT04263987|BG002|Baseline|Total|Total of all reporting groups
10807287|NCT04263987|FG000|Participant Flow|Holmium Laser Enucleation of Prostate|"Traditional holmium laser enucleation of the prostate as currently performed~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807288|NCT04263987|FG001|Participant Flow|Moses Holmium Laser Enucleation of Prostate|"holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807289|NCT04263987|OG000|Outcome|Holmium Laser Enucleation of Prostate|"Traditional holmium laser enucleation of the prostate as currently performed~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807290|NCT04263987|OG001|Outcome|Moses Holmium Laser Enucleation of Prostate|"holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
11092249|NCT01538472|BG000|Baseline|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
10807291|NCT04263987|EG000|Reported Event|Holmium Laser Enucleation of Prostate|"Traditional holmium laser enucleation of the prostate as currently performed~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807292|NCT04263987|EG001|Reported Event|Moses Holmium Laser Enucleation of Prostate|"holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.~Moses laser enucleation of prostate: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time"
10807293|NCT04223830|BG000|Baseline|Exalt DScope 01B|"Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.~Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device."
10807294|NCT04223830|FG000|Participant Flow|Exalt DScope 01B|"Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.~Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device."
10807295|NCT04223830|OG000|Outcome|Exalt DScope 01B|"Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.~Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device."
10807296|NCT04223830|OG000|Outcome|Exalt DScope 01B|Overall satisfaction
10807297|NCT04223830|EG000|Reported Event|Exalt DScope 01B|"Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.~Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device."
10807298|NCT04153435|BG000|Baseline|Calcium|"The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Calcium Chloride: Calcium chloride 5 mmol"
10807299|NCT04153435|BG001|Baseline|Placebo|"The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, normal saline) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Sodium chloride 0.9%: Placebo"
10807300|NCT04153435|BG002|Baseline|Total|Total of all reporting groups
10807301|NCT04153435|FG000|Participant Flow|Calcium|"The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Calcium Chloride: Calcium chloride 5 mmol"
11205168|NCT02226562|OG000|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
11205169|NCT02226562|OG001|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
11205170|NCT02226562|EG000|Reported Event|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
10807302|NCT04153435|FG001|Participant Flow|Placebo|"The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, normal saline) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Sodium chloride 0.9%: Placebo"
10807303|NCT04153435|OG000|Outcome|Calcium|"The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Calcium Chloride: Calcium chloride 5 mmol"
10807304|NCT04153435|OG001|Outcome|Placebo|"The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, normal saline) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Sodium chloride 0.9%: Placebo"
10807305|NCT04153435|EG000|Reported Event|Calcium|"The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Calcium Chloride: Calcium chloride 5 mmol"
10807306|NCT04153435|EG001|Reported Event|Placebo|"The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, normal saline) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.~Sodium chloride 0.9%: Placebo"
10807307|NCT04153188|BG000|Baseline|Pulsed Dye Laser & Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.~The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807308|NCT04153188|BG001|Baseline|Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807309|NCT04153188|BG002|Baseline|Total|Total of all reporting groups
10807310|NCT04153188|FG000|Participant Flow|Pulsed Dye Laser & Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.~The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807311|NCT04153188|FG001|Participant Flow|Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807312|NCT04153188|OG000|Outcome|Pulsed Dye Laser & Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.~The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807313|NCT04153188|OG001|Outcome|Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807314|NCT04153188|EG000|Reported Event|Pulsed Dye Laser & Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.~The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807315|NCT04153188|EG001|Reported Event|Oxymetazoline HCL 1% Cream|"Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.~Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study."
10807316|NCT04108429|BG000|Baseline|Mobile Self-help Intervention|"Participants will have open access to the IntelliCare system.~IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
10807317|NCT04108429|FG000|Participant Flow|Mobile Self-help Intervention|"Participants will have open access to the IntelliCare system.~IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
10807318|NCT04108429|OG000|Outcome|Mobile Self-help Intervention|"Participants will have open access to the IntelliCare system.~IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
10807319|NCT04108429|OG000|Outcome|University A|Counseling Center Utilization at University A
10807320|NCT04108429|OG001|Outcome|University B|Counseling Center Utilization at University B
11205171|NCT02226562|EG001|Reported Event|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
11205172|NCT02226653|BG000|Baseline|Reference/Test/Reference/Test/Test|Reference(R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
10807321|NCT04108429|EG000|Reported Event|Mobile Self-help Intervention|"Participants will have open access to the IntelliCare system.~IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day"
10820768|NCT00062868|BG000|Baseline|LMP2A CTLs (ALASCER) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820769|NCT00062868|BG001|Baseline|LMP2A CTLs (ALASCER) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820770|NCT00062868|BG002|Baseline|LMP2A CTLs (ALASCER) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820771|NCT00062868|BG003|Baseline|LMP2A CTLs (ALASCER) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820772|NCT00062868|BG004|Baseline|LMP2A CTLs (ALASCER) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820773|NCT00062868|BG005|Baseline|LMP2A CTLs (ALASCER) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820774|NCT00062868|BG006|Baseline|LMP2A CTLs (ALASCER) - Group C DL1|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
10820775|NCT00062868|BG007|Baseline|LMP2A CTLs (ALASCER) - Group C DL2|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).
10820776|NCT00062868|BG008|Baseline|LMP2A CTLs (ALASCER) - Group C DL3|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).
10820777|NCT00062868|BG009|Baseline|LMP1/2 CTLs (ALCI) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820778|NCT00062868|BG010|Baseline|LMP1/2 CTLs (ALCI) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820779|NCT00062868|BG011|Baseline|LMP1/2 CTLs (ALCI) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820780|NCT00062868|BG012|Baseline|LMP1/2 CTLs (ALCI) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820781|NCT00062868|BG013|Baseline|LMP1/2 CTLs (ALCI) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820782|NCT00062868|BG014|Baseline|LMP1/2 CTLs (ALCI) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
11205173|NCT02226653|BG001|Baseline|Test/Reference/Test/Reference/Reference|Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Reference (R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
10820783|NCT00062868|BG015|Baseline|LMP1/2 CTLs (ALCI) - Group C DL1|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
10820784|NCT00062868|BG016|Baseline|LMP1/2 CTLs (ALCI) - Group C DL2|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)
10820785|NCT00062868|BG017|Baseline|LMP1/2 CTLs (ALCI) - Group C DL3|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).
10820786|NCT00062868|BG018|Baseline|LMP1/2 CTLs (ALCI - Expansion Group A)|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820787|NCT00062868|BG019|Baseline|LMP1/2 CTLs (ALCI - Expansion Group B)|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
11205174|NCT02226653|BG002|Baseline|Total|Total of all reporting groups
11205175|NCT02226653|FG000|Participant Flow|Reference/Test/Reference/Test/Test|Reference (R) dose is a single oral dose of one - 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Test (T) dose is a single oral dose of Test two - 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
10807322|NCT04531098|BG000|Baseline|Sci-B-Vac-Lot B|The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807323|NCT04531098|BG001|Baseline|Engerix-B|The mono-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.
10807324|NCT04531098|BG002|Baseline|Sci-B-Vac-Lot A|The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807325|NCT04531098|BG003|Baseline|Total|Total of all reporting groups
10807326|NCT04531098|FG000|Participant Flow|Sci-B-Vac-Lot B|The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807327|NCT04531098|FG001|Participant Flow|Engerix-B|The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.
10807328|NCT04531098|FG002|Participant Flow|Sci-B-Vac-Lot A|The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807329|NCT04531098|OG000|Outcome|Sci-B-Vac-Lot B|The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807330|NCT04531098|OG001|Outcome|Engerix-B|The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.
10807331|NCT04531098|OG002|Outcome|Sci-B-Vac-Lot A|The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807332|NCT04531098|EG000|Reported Event|Sci-B-Vac-Lot B|The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807333|NCT04531098|EG001|Reported Event|Engerix-B|The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.
10807334|NCT04531098|EG002|Reported Event|Sci-B-Vac-Lot A|The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
10807335|NCT04233008|BG000|Baseline|6 Hour Foley|Foley for up to 6 hours
10807336|NCT04233008|BG001|Baseline|12 Hour Foley|Foley up to 12 hours
10807337|NCT04233008|BG002|Baseline|Total|Total of all reporting groups
10807338|NCT04233008|FG000|Participant Flow|6 Hour Foley|"The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.~Foley catheter length: see arm description"
10807339|NCT04233008|FG001|Participant Flow|12 Hour Foley|The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
10807340|NCT04233008|OG000|Outcome|6 Hour Foley|"The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.~Foley catheter length: see arm description"
10807341|NCT04233008|OG001|Outcome|12 Hour Foley|The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
10807342|NCT04233008|EG000|Reported Event|6 Hour Foley - Mothers|"The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.~Foley catheter length: see arm description"
10807343|NCT04233008|EG001|Reported Event|12 Hour Foley - Mothers|The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
10807344|NCT04233008|EG002|Reported Event|6 Hour Foley - Neonates|"The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.~Foley catheter length: see arm description"
10807345|NCT04233008|EG003|Reported Event|12 Hour Foley - Neonates|The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
10807346|NCT04179786|BG000|Baseline|Sci-B-Vac™|"Single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and who were seronegative for antibodies to HBsAg, HBc and HBs at baseline.~Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension."
10807347|NCT04179786|FG000|Participant Flow|Sci-B-Vac™|"Single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and who were seronegative for antibodies to HBsAg, HBc and HBs at baseline.~Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension."
10807348|NCT04179786|OG000|Outcome|Sci-B-Vac™|"Single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and who were seronegative for antibodies to HBsAg, HBc and HBs at baseline.~Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension."
10807349|NCT04179786|EG000|Reported Event|Sci-B-Vac™|"Single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and who were seronegative for antibodies to HBsAg, HBc and HBs at baseline.~Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension."
10807350|NCT04140292|BG000|Baseline|Vitamin D3 + Photodynamic Therapy (PDT)|"Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.~Photodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.~Vitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
10807351|NCT04140292|BG001|Baseline|Photodynamic Therapy (PDT)|Data for the participants in this arm are from a previous basic science study that looked at Vit D level that got standard of care PDT. These participants were used as a control group.
10807352|NCT04140292|BG002|Baseline|Total|Total of all reporting groups
10807353|NCT04140292|FG000|Participant Flow|Vitamin D3 + Photodynamic Therapy (PDT)|"Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.~Photodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.~Vitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
10807354|NCT04140292|FG001|Participant Flow|Photodynamic Therapy (PDT)|Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.
10807355|NCT04140292|OG000|Outcome|Vitamin D3 + Photodynamic Therapy (PDT)|"Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.~Photodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.~Vitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
10807356|NCT04140292|OG001|Outcome|Photodynamic Therapy (PDT)|Participants will be matched to other participants from a prior study (NCT03467789) involving PDT only, based on their baseline vitamin D level. These participants were used as a control group.
11244279|NCT02509767|BG000|Baseline|Self-Administration|"Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
10820788|NCT00062868|BG020|Baseline|LMP1/2 CTLs (ALCI - Expansion Group C)|Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)
10820789|NCT00062868|BG021|Baseline|Total|Total of all reporting groups
10807357|NCT04140292|OG000|Outcome|Vitamin D3 + Photodynamic Therapy (PDT)|"Participants receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.~Photodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.~Vitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
10807358|NCT04140292|EG000|Reported Event|Vitamin D3 + Photodynamic Therapy (PDT)|"Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.~Photodynamic therapy (PDT): PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.~Vitamin D3: D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
10807359|NCT04140292|EG001|Reported Event|Photodynamic Therapy (PDT)|Data for the participants in this arm are from a previous basic science study that looked at Vit D level that got standard of care PDT. These participants were used as a control group.
10807360|NCT04064229|BG000|Baseline|Infiltrated Tissue|"The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
10807361|NCT04064229|FG000|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
10807362|NCT04064229|OG000|Outcome|SmartTouch Sensor|ivWatch Model 400 with SmartTouch sensor used to monitor IV site
10807363|NCT04064229|OG001|Outcome|Fiber Optic Sensor|ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
10807364|NCT04064229|EG000|Reported Event|SmartTouch Sensor|ivWatch Model 400 with SmartTouch sensor used to monitor IV site
10807365|NCT04064229|EG001|Reported Event|Fiber Optic Sensor|ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
10807366|NCT03993938|BG000|Baseline|Patients for TMVR|"Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.~PVI measurement: Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment"
10807367|NCT03993938|FG000|Participant Flow|Patients for TMVR|"Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.~PVI measurement: Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment"
10807368|NCT03993938|OG000|Outcome|Patients for TMVR|"Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.~PVI measurement: Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment"
10820790|NCT00062868|FG000|Participant Flow|LMP2A CTLs (ALASCER) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820791|NCT00062868|FG001|Participant Flow|LMP2A CTLs (ALASCER) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
11286159|NCT02884492|BG001|Baseline|No Cognitive Impairment|"Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
11286160|NCT02884492|BG002|Baseline|Total|Total of all reporting groups
10807369|NCT03993938|EG000|Reported Event|Patients for TMVR|"Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.~PVI measurement: Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment"
10807370|NCT03912805|BG000|Baseline|Vehicle|"Vehicle, topical liniment, administered once at baseline~Vehicle: Vehicle Formulation"
10807371|NCT03912805|BG001|Baseline|ET-01|"botulinum toxin, Type A, topical liniment, administered once at baseline~botulinum toxin, Type A: topical liniment"
10807372|NCT03912805|BG002|Baseline|Total|Total of all reporting groups
10807373|NCT03912805|FG000|Participant Flow|Vehicle|"Vehicle, topical liniment, administered once at baseline~Vehicle: Vehicle Formulation"
10807374|NCT03912805|FG001|Participant Flow|ET-01|"botulinum toxin, Type A, topical liniment, administered once at baseline~botulinum toxin, Type A: topical liniment"
10807375|NCT03912805|OG000|Outcome|Vehicle|"Vehicle, topical liniment, administered once at baseline~Vehicle: Vehicle Formulation"
10807376|NCT03912805|OG001|Outcome|ET-01|"botulinum toxin, Type A, topical liniment, administered once at baseline~botulinum toxin, Type A: topical liniment"
10807377|NCT03912805|EG000|Reported Event|Vehicle|"Vehicle, topical liniment, administered once at baseline~Vehicle: Vehicle Formulation"
10807378|NCT03912805|EG001|Reported Event|ET-01|"botulinum toxin, Type A, topical liniment, administered once at baseline~botulinum toxin, Type A: topical liniment"
10807379|NCT03740724|BG000|Baseline|FCX-013 + Veledimex|"Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily~FCX-013: FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally.~veledimex: Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration"
10807380|NCT03740724|FG000|Participant Flow|FCX-013 + Veledimex|"Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily~FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally.~Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration"
10807381|NCT03740724|OG000|Outcome|FCX-013 + Veledimex|"Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily~FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally.~Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration"
10807382|NCT03740724|EG000|Reported Event|FCX-013 + Veledimex|"Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily~FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally.~Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration"
10807383|NCT03730012|BG000|Baseline|Gilteritinib 120 mg + Atezolizumab 420 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
10807384|NCT03730012|BG001|Baseline|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10807385|NCT03730012|BG002|Baseline|Total|Total of all reporting groups
10807386|NCT03730012|FG000|Participant Flow|Gilteritinib 120 mg + Atezolizumab 420 mg|Participants received 120 mg (milligrams) giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
10807387|NCT03730012|FG001|Participant Flow|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10820792|NCT00062868|FG002|Participant Flow|LMP2A CTLs (ALASCER) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10807388|NCT03730012|OG000|Outcome|Gilteritinib 120 mg + Atezolizumab 420 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
10807389|NCT03730012|OG001|Outcome|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg administered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10807390|NCT03730012|OG001|Outcome|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10807391|NCT03730012|OG000|Outcome|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10807392|NCT03730012|OG001|Outcome|Gilteritinib 120 mg + Atezolizumab 420 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
10807393|NCT03730012|EG000|Reported Event|Gilteritinib 120 mg + Atezolizumab 420 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
10807394|NCT03730012|EG001|Reported Event|Gilteritinib 120 mg + Atezolizumab 840 mg|Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).
10807395|NCT03553836|BG000|Baseline|Pembrolizumab|Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807396|NCT03553836|BG001|Baseline|Placebo|Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807397|NCT03553836|BG002|Baseline|Total|Total of all reporting groups
10807398|NCT03553836|FG000|Participant Flow|Pembrolizumab|Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807399|NCT03553836|FG001|Participant Flow|Placebo|Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807400|NCT03553836|OG000|Outcome|Pembrolizumab|Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1.
10807401|NCT03553836|OG001|Outcome|Placebo|Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1.
10807402|NCT03553836|EG000|Reported Event|Pembrolizumab|Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807403|NCT03553836|EG001|Reported Event|Placebo|Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10807404|NCT03553836|EG002|Reported Event|Placebo Switched Over to Pembrolizumab|Participants who received the initial treatment of saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1 and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
10820793|NCT00062868|FG003|Participant Flow|LMP2A CTLs (ALASCER) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10967047|NCT00891046|OG000|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment- naive and who discontinued other biologics due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967048|NCT00891046|OG001|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued other biologics for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967049|NCT00891046|OG002|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued other biologics for other reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967050|NCT00891046|OG003|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to other biologics, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967051|NCT00891046|OG000|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967052|NCT00891046|OG001|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 - Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967053|NCT00891046|OG002|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study -Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967054|NCT00891046|OG003|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967055|NCT00891046|OG004|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967056|NCT00891046|OG000|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967057|NCT00891046|OG001|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967058|NCT00891046|OG002|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967059|NCT00891046|OG003|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967060|NCT00891046|EG000|Reported Event|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
10967061|NCT00891046|EG001|Reported Event|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
10967062|NCT00891176|BG000|Baseline|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967063|NCT00891176|BG001|Baseline|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967064|NCT00891176|BG002|Baseline|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10847579|NCT00283842|EG003|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
10847580|NCT00283842|EG004|Reported Event|Placebo|
10807405|NCT03474107|BG000|Baseline|Enfortumab Vedotin 1.25 mg/kg|Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807406|NCT03474107|BG001|Baseline|Chemotherapy|Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807407|NCT03474107|BG002|Baseline|Total|Total of all reporting groups
10807408|NCT03474107|FG000|Participant Flow|Enfortumab Vedotin 1.25mg/kg|Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807409|NCT03474107|FG001|Participant Flow|Chemotherapy|Participants received either 75 milligram per square meter (mg/m^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807410|NCT03474107|OG000|Outcome|Enfortumab Vedotin 1.25 mg/kg|Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807411|NCT03474107|OG001|Outcome|Chemotherapy|Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807412|NCT03474107|EG000|Reported Event|Enfortumab Vedotin|Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807413|NCT03474107|EG001|Reported Event|Chemotherapy|Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
10807414|NCT02979522|BG000|Baseline|Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807415|NCT02979522|BG001|Baseline|Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807416|NCT02979522|BG002|Baseline|Total|Total of all reporting groups
10807417|NCT02979522|FG000|Participant Flow|Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807418|NCT02979522|FG001|Participant Flow|Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807419|NCT02979522|OG000|Outcome|Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
10807420|NCT02979522|OG000|Outcome|Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group.
10807421|NCT02979522|OG000|Outcome|Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included.
10820794|NCT00062868|FG004|Participant Flow|LMP2A CTLs (ALASCER) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10807422|NCT02979522|OG001|Outcome|Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807423|NCT02979522|OG000|Outcome|Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807424|NCT02979522|OG000|Outcome|Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807425|NCT02979522|OG000|Outcome|Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group.
10807426|NCT02979522|OG000|Outcome|Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807427|NCT02979522|EG000|Reported Event|Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group.
10807428|NCT02979522|EG001|Reported Event|Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD|Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
10807429|NCT02954237|BG000|Baseline|AMPLATZER™ Cardiac Plug|"Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.~AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)"
10807430|NCT02954237|FG000|Participant Flow|AMPLATZER™ Cardiac Plug|"Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.~AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)"
10807431|NCT02954237|OG000|Outcome|AMPLATZER™ Cardiac Plug|"Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.~AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)"
10807432|NCT02954237|EG000|Reported Event|AMPLATZER™ Cardiac Plug|"Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.~AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)"
10820795|NCT00062868|FG005|Participant Flow|LMP2A CTLs (ALASCER) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
11244280|NCT02509767|BG001|Baseline|Clinic Administration (Standard Care)|"Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
10807433|NCT02856581|BG000|Baseline|Intervention Group (Varenicline and Behavioral Intervention)|"Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Varenicline: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807434|NCT02856581|BG001|Baseline|Control Group (Placebo and Behavioral Intervention)|"Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Placebo: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807435|NCT02856581|BG002|Baseline|Total|Total of all reporting groups
10807436|NCT02856581|FG000|Participant Flow|Intervention Group (Varenicline and Behavioral Intervention)|"Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Varenicline: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807437|NCT02856581|FG001|Participant Flow|Control Group (Placebo and Behavioral Intervention)|"Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Placebo: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807438|NCT02856581|OG000|Outcome|Intervention Group (Varenicline and Behavioral Intervention)|"Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Varenicline: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807439|NCT02856581|OG001|Outcome|Control Group (Placebo and Behavioral Intervention)|"Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.> > Placebo: Given PO>~> Tobacco Cessation Counseling: Complete counseling session"
10807440|NCT02856581|EG000|Reported Event|Intervention Group (Varenicline and Behavioral Intervention)|Tobacco Cessation Counseling: Complete counseling session
10807441|NCT02856581|EG001|Reported Event|Control Group (Placebo and Behavioral Intervention)|Tobacco Cessation Counseling: Complete counseling session
10807442|NCT02714218|BG000|Baseline|Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV|nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
10807443|NCT02714218|BG001|Baseline|Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV|nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
10807444|NCT02714218|BG002|Baseline|Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg|nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
10807445|NCT02714218|BG003|Baseline|Total|Total of all reporting groups
10807446|NCT02714218|FG000|Participant Flow|Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV|nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
10807447|NCT02714218|FG001|Participant Flow|Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV|nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
10807448|NCT02714218|FG002|Participant Flow|Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg|nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
10807449|NCT02714218|OG000|Outcome|Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV|nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
10807450|NCT02714218|OG001|Outcome|Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV|nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
10807451|NCT02714218|EG000|Reported Event|Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV|nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
10807452|NCT02714218|EG001|Reported Event|Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV|nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
10807453|NCT02714218|EG002|Reported Event|Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg|nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
10807454|NCT02677896|BG000|Baseline|Enzalutamide + Androgen Deprivation Therapy (ADT)|Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10820796|NCT00062868|FG006|Participant Flow|LMP2A CTLs (ALASCER) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820797|NCT00062868|FG007|Participant Flow|LMP2A CTLs (ALASCER) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10847581|NCT00283933|BG000|Baseline|Migalastat|Migalastat 150 mg was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
10807455|NCT02677896|BG001|Baseline|Placebo + Androgen Deprivation Therapy (ADT)|Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807456|NCT02677896|BG002|Baseline|Total|Total of all reporting groups
10807457|NCT02677896|FG000|Participant Flow|Enzalutamide + Androgen Deprivation Therapy (ADT)|Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807458|NCT02677896|FG001|Participant Flow|Placebo + Androgen Deprivation Therapy (ADT)|Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807459|NCT02677896|OG000|Outcome|Enzalutamide + Androgen Deprivation Therapy (ADT)|Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807460|NCT02677896|OG001|Outcome|Placebo + Androgen Deprivation Therapy (ADT)|Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807461|NCT02677896|EG000|Reported Event|Enzalutamide + Androgen Deprivation Therapy (ADT)|Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
10807462|NCT02677896|EG001|Reported Event|Placebo + Androgen Deprivation Therapy|Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. This arm represents only double blind period.
10820798|NCT00062868|FG008|Participant Flow|LMP2A CTLs (ALASCER) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10847582|NCT00283933|FG000|Participant Flow|Migalastat|Migalastat 150 milligrams (mg) was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
11205176|NCT02226653|FG001|Participant Flow|Test/Reference/Test/Reference/Reference|Test (T) dose is a single oral dose of two - 65 milligram (mg) tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Reference (R) is a single oral dose of Reference (R) one - 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
11205177|NCT02226653|OG000|Outcome|Reference (Fasted)|Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
11205178|NCT02226653|OG001|Outcome|Test (Fasted)|Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
11205179|NCT02226653|OG000|Outcome|Reference (Fasted)|Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Periods 2 and 4.
11205180|NCT02226653|OG001|Outcome|Reference (Fed)|Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fed state in Period 5.
11205181|NCT02226653|OG002|Outcome|Test (Fasted)|Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
11205182|NCT02226653|OG003|Outcome|Test (Fed)|Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
11205183|NCT02226653|OG001|Outcome|Reference (Fed)|Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fed state in Periods 5.
11205184|NCT02226653|EG000|Reported Event|130 mg Tablet Evacetrapib (Fasted)|Reference dose is a single oral dose of Reference one- 130 mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.
11205185|NCT02226653|EG001|Reported Event|2 x 65 mg Tablets Evacetrapib (Fasted)|Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.
11205186|NCT02226653|EG002|Reported Event|130 mg Tablet Evacetrapib (Fed)|Reference dose is a single oral dose of Reference one- 130 mg tablets of in fed state in Period 5.
11205187|NCT02226653|EG003|Reported Event|2 x 65 mg Tablets Evacetrapib (Fed)|Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
11205188|NCT02226796|BG000|Baseline|Sham Controlled tDCS Combined With Behavioral Naming Treatment|"The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.~The non-prime (NONPRIME) condition, sham/control is an intervention that will consist of 40 minutes of naming treatment only, followed by an additional 20 minutes of concurrent naming treatment with a-tDCS.~Behavioral measures taken include: working memory, naming reaction time and naming accuracy"
11205189|NCT02226796|FG000|Participant Flow|Primed tDCS Condition First, Then Non-Prime Condition|"The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.~The non-primed (NONPRIMED) condition, or sham/control is an intervention that will consist of presentation of sham tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair."
11205190|NCT02226796|FG001|Participant Flow|Non-Prime Condition First, Then Primed Condition|"The non-primed (NONPRIMED) condition, or sham/control is an intervention that will consist of presentation of sham tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.~The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair."
11205191|NCT02226796|OG000|Outcome|Prime Condition|"The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to the dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention."
11205192|NCT02226796|OG001|Outcome|Non-Prime Condition/Control|"The non-primed (NON-PRIME) condition, or sham controlled, is an intervention that will consist of presentation of sham tDCS to the dorsolateral prefrontal cortex for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.~Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention."
11205193|NCT02226796|EG000|Reported Event|Primed tDCS Condition|The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair. Naming reaction time and accuracy will be measured as well as working memory.
11205194|NCT02226796|EG001|Reported Event|Non-Prime Condition|The non-primed (NONPRIMED) condition, or sham/control is an intervention that will consist of presentation of sham tDCS for 20 minutes to dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair. Naming reaction time and accuracy will be measured as well as working memory.
11205195|NCT02226965|BG000|Baseline|PNT2258|PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.
11205196|NCT02226965|FG000|Participant Flow|PNT2258|PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.
11205197|NCT02226965|OG000|Outcome|PNT2258|PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.
11244281|NCT02509767|BG002|Baseline|Total|Total of all reporting groups
10807463|NCT02677896|EG002|Reported Event|Placebo Cross-over Enzalutamide|Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. This arm represents only the open-label extension period.
10807464|NCT02652949|BG000|Baseline|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
10807465|NCT02652949|FG000|Participant Flow|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
10807466|NCT02652949|OG000|Outcome|Endovascular Repair|"Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).~Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS)."
10807467|NCT02652949|OG000|Outcome|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
10807468|NCT02652949|OG000|Outcome|Endovascular Repair|Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
10807469|NCT02652949|EG000|Reported Event|Endovascular Repair 30-Day Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.~For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval."
10807470|NCT02652949|EG001|Reported Event|Endovascular Repair 6-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.~For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval."
10807471|NCT02652949|EG002|Reported Event|Endovascular Repair 12-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.~For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval."
10807472|NCT02652949|EG003|Reported Event|Endovascular Repair 24-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.~For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval."
10807473|NCT02652949|EG004|Reported Event|Endovascular Repair 36-Month Secondary Endpoint|"Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR)~For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days.~For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval."
10807474|NCT02649439|BG000|Baseline|A/PROSTVAC Treatment|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807475|NCT02649439|BG001|Baseline|B/ Delayed PROSTVAC Treatment|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807476|NCT02649439|BG002|Baseline|Total|Total of all reporting groups
10807477|NCT02649439|FG000|Participant Flow|A/PROSTVAC Treatment|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807478|NCT02649439|FG001|Participant Flow|B/ Delayed PROSTVAC Treatment|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10847583|NCT00283933|OG000|Outcome|Migalastat|Migalastat 150 mg was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
10807479|NCT02649439|OG000|Outcome|A/PROSTVAC Treatment|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807480|NCT02649439|OG001|Outcome|B/ Delayed PROSTVAC Treatment|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807481|NCT02649439|OG000|Outcome|A/PROSTVAC Treatment Responders|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807482|NCT02649439|OG001|Outcome|B/ Delayed PROSTVAC Treatment Non-Responders|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807483|NCT02649439|OG001|Outcome|A/PROSTVAC Treatment Non-Responders|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807484|NCT02649439|OG000|Outcome|A/PROSTVAC Treatment Day 1|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807485|NCT02649439|OG001|Outcome|A/PROSTVAC Treatment Day 29|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807486|NCT02649439|OG002|Outcome|B/ Delayed PROSTVAC Treatment Day 1|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807487|NCT02649439|OG003|Outcome|B/ Delayed PROSTVAC Treatment Day 29|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807488|NCT02649439|EG000|Reported Event|A/PROSTVAC Treatment|"PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807489|NCT02649439|EG001|Reported Event|B/ Delayed PROSTVAC Treatment|"Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients~PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus~PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus"
10807490|NCT02634307|BG000|Baseline|De Novo|Participants who had not received ALKS 8700 or DMF were administered ALKS 8700 231 mg capsules orally, BID on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96.
10807491|NCT02634307|BG001|Baseline|Rollover: ALKS 8700|Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807492|NCT02634307|BG002|Baseline|Rollover: DMF|Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807493|NCT02634307|BG003|Baseline|Total|Total of all reporting groups
10807494|NCT02634307|FG000|Participant Flow|De Novo|Participants who had not received ALKS 8700 or dimethyl fumarate (DMF) were administered ALKS 8700 231 milligrams (mg) capsules orally, twice daily (BID) on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96.
10807495|NCT02634307|FG001|Participant Flow|Rollover: ALKS 8700|Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807496|NCT02634307|FG002|Participant Flow|Rollover: DMF|Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807497|NCT02634307|OG000|Outcome|De Novo|Participants who had not received ALKS 8700 or DMF were administered ALKS 8700 231 mg capsules orally, BID on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96.
10807498|NCT02634307|OG001|Outcome|Rollover: ALKS 8700|Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807499|NCT02634307|OG002|Outcome|Rollover: DMF|Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807500|NCT02634307|EG000|Reported Event|De Novo|Participants who had not received ALKS 8700 or DMF were administered ALKS 8700 231 mg capsules orally, BID on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96.
10807501|NCT02634307|EG001|Reported Event|Rollover: ALKS 8700|Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10807502|NCT02634307|EG002|Reported Event|Rollover: DMF|Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96.
10820799|NCT00062868|FG009|Participant Flow|LMP1/2 CTLs (ALCI) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820800|NCT00062868|FG010|Participant Flow|LMP1/2 CTLs (ALCI) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10847584|NCT00283933|EG000|Reported Event|Migalastat|Migalastat 150 mg was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
10807503|NCT02579811|BG000|Baseline|Axitinib|"All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion.~Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria"
10807504|NCT02579811|FG000|Participant Flow|Axitinib|"All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion.~Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria"
10807505|NCT02579811|OG000|Outcome|Axitinib|"All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion.~Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria"
10807506|NCT02579811|EG000|Reported Event|Axitinib|"All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion.~Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria"
10807507|NCT02447718|BG000|Baseline|Experimental|"Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.~Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.~Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13~Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy."
10807508|NCT02447718|BG001|Baseline|Healthy Control|Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
10807509|NCT02447718|BG002|Baseline|Total|Total of all reporting groups
10807510|NCT02447718|FG000|Participant Flow|Experimental|"Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.~Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.~Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13~Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy."
10807511|NCT02447718|FG001|Participant Flow|Healthy Control|Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
10807512|NCT02447718|OG000|Outcome|Experimental|"Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.~Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.~Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13~Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy."
10807513|NCT02447718|OG001|Outcome|Healthy Control|Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
10807514|NCT02447718|OG000|Outcome|Experimental|"Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.~Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.~Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13 Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy."
10807515|NCT02447718|EG000|Reported Event|DTaP-IPV-HiB+PCV13|"DTaP-IPV-Hib: diphtheria-tetanus-acellular pertussis-inactivated polio-H. influenzae type b vaccine~PCV13: 13-valent pneumococcal conjugate vaccine"
10807516|NCT02447718|EG001|Reported Event|PPV23|PPV23: 23-valent pneumococcal polysaccharide vaccine
10807517|NCT02157883|BG000|Baseline|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
10820801|NCT00062868|FG011|Participant Flow|LMP1/2 CTLs (ALCI) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10807518|NCT02157883|FG000|Participant Flow|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
10807519|NCT02157883|OG000|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
10807520|NCT02157883|OG001|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
10807521|NCT02157883|EG000|Reported Event|Overall Safety Population|Parts A and B of the study combined.
10807522|NCT02157883|EG001|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods (AZD9291 dosing on Days 1 and 10). Patients additionally received itraconazole 200 mg twice daily dosing from Days 6 to 18.
10807523|NCT02157883|EG002|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
10807524|NCT01962948|BG000|Baseline|Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807525|NCT01962948|BG001|Baseline|Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807526|NCT01962948|BG002|Baseline|Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807527|NCT01962948|BG003|Baseline|Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel|Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
10807528|NCT01962948|BG004|Baseline|Total|Total of all reporting groups
10807529|NCT01962948|FG000|Participant Flow|Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807530|NCT01962948|FG001|Participant Flow|Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807531|NCT01962948|FG002|Participant Flow|Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807532|NCT01962948|FG003|Participant Flow|Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel|Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
10807533|NCT01962948|OG000|Outcome|Treatment (Paclitaxel, Ganetespib)|"Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~ganetespib: Given IV~laboratory biomarker analysis: Correlative studies"
10807534|NCT01962948|EG000|Reported Event|Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807535|NCT01962948|EG001|Reported Event|Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807536|NCT01962948|EG002|Reported Event|Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel|Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
10807537|NCT01962948|EG003|Reported Event|Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel|Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
10807538|NCT01938001|BG000|Baseline|Rituximab Plus Lenalidomide (R^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
10807539|NCT01938001|BG001|Baseline|Rituximab Plus Placebo|Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
10807540|NCT01938001|BG002|Baseline|Total|Total of all reporting groups
10820802|NCT00062868|FG012|Participant Flow|LMP1/2 CTLs (ALCI) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10807541|NCT01938001|FG000|Participant Flow|Rituximab Plus Lenalidomide (R^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
10807542|NCT01938001|FG001|Participant Flow|Rituximab Plus Placebo|Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
10807543|NCT01938001|OG000|Outcome|Rituximab Plus Lenalidomide (R^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
10807544|NCT01938001|OG001|Outcome|Rituximab Plus Placebo|Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
10807545|NCT01938001|EG000|Reported Event|Rituximab and Lenalidomide|Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
10807546|NCT01938001|EG001|Reported Event|Rituximab and Placebo|Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
10807547|NCT01529008|BG000|Baseline|Core Decompression/PREOB® Implantation|Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
10807548|NCT01529008|BG001|Baseline|Core Decompression/Placebo Implantation|Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
10807549|NCT01529008|BG002|Baseline|Total|Total of all reporting groups
10807550|NCT01529008|FG000|Participant Flow|Core Decompression/PREOB® Implantation|Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
10807551|NCT01529008|FG001|Participant Flow|Core Decompression/Placebo Implantation|Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
10807552|NCT01529008|OG000|Outcome|Core Decompression/PREOB® Implantation|Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
11205198|NCT02226965|EG000|Reported Event|PNT2258|PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.
10807553|NCT01529008|OG001|Outcome|Core Decompression/Placebo Implantation|Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
10807554|NCT01529008|EG000|Reported Event|Core Decompression/PREOB® Implantation|Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
10807555|NCT01529008|EG001|Reported Event|Core Decompression/Placebo Implantation|Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
10807556|NCT01484691|BG000|Baseline|Healthy Non-asthmatic Controls|Healthy non-asthmatic controls who will be studied at one point in time and serve as a control group for the baseline bronchoscopy and evaluation of T-cell miRNA expression.
10807557|NCT01484691|BG001|Baseline|Asthmatics (Treatment)|"Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids.~Budesonide: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10807558|NCT01484691|BG002|Baseline|Asthmatics (no Treatment)|Steroid-naïve asthma (randomized to 8 weeks of no inhaled corticosteroid treatment). Asthmatics not on inhaled corticosteroids, randomized to no change in treatment for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline and again after 8 weeks without treatment with inhaled corticosteroids.
10807559|NCT01484691|BG003|Baseline|Total|Total of all reporting groups
10807560|NCT01484691|FG000|Participant Flow|Healthy Non-asthmatic Controls|Healthy non-asthmatic controls who will be studied at one point in time and serve as a control group for the baseline bronchoscopy and evaluation of T-cell miRNA expression.
10807561|NCT01484691|FG001|Participant Flow|Asthmatics (Treatment)|"Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids.~Budesonide: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10807562|NCT01484691|FG002|Participant Flow|Asthmatics (no Treatment)|Steroid-naïve asthma (randomized to 8 weeks of no inhaled corticosteroid treatment). Asthmatics not on inhaled corticosteroids, randomized to no change in treatment for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline and again after 8 weeks without treatment with inhaled corticosteroids.
10807563|NCT01484691|OG000|Outcome|Healthy Non-asthmatic Controls|Healthy non-asthmatic controls who underwent bronchoscopy at one time point and served as a control group for the asthmatics group for evaluation of T-cell miRNA expression.
10807564|NCT01484691|OG001|Outcome|Asthmatics (Baseline)|All steroid-naïve asthmatics. These subjects were studied before and after randomization to study drug or no treatment. The pre-randomization data were collected on these asthmatics as one uniform group for comparison to healthy controls. These subjects then underwent bronchoscopy and T-cell miRNA measurement at pre-randomization and again 8 weeks after randomization to inhaled corticosteroids or no treatment.
10807565|NCT01484691|OG000|Outcome|Asthmatics (Treatment)|"Asthmatics randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at pre-randomization (before corticosteroids) and again after treatment with inhaled corticosteroids.~Budesonide: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10807566|NCT01484691|OG001|Outcome|Asthmatics (no Treatment)|Asthmatics randomized to no treatment with inhaled corticosteroids for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at pre-randomization and again 8 weeks after randomization to no treatment with inhaled corticosteroids.
10807567|NCT01484691|EG000|Reported Event|Healthy Non-asthmatic Controls|Healthy non-asthmatic controls who will be studied at one point in time and serve as a control group for the baseline bronchoscopy and evaluation of T-cell miRNA expression.
10807568|NCT01484691|EG001|Reported Event|Asthmatics (Treatment)|"Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids.~Budesonide: Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
10807569|NCT01484691|EG002|Reported Event|Asthmatics (no Treatment)|Steroid-naïve asthma (randomized to 8 weeks of no inhaled corticosteroid treatment). Asthmatics not on inhaled corticosteroids, randomized to no change in treatment for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline and again after 8 weeks without treatment with inhaled corticosteroids.
10807570|NCT01125371|BG000|Baseline|Computerized Brief Alcohol Intervention + IVR|"Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)~Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages"
10807571|NCT01125371|BG001|Baseline|Computerized Brief Alcohol Intervention|"Computerized Brief Alcohol Intervention only (CBI)~Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time"
10807572|NCT01125371|BG002|Baseline|Attention Control|"Attention control~Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once"
10807573|NCT01125371|BG003|Baseline|Total|Total of all reporting groups
10807574|NCT01125371|FG000|Participant Flow|Computerized Brief Alcohol Intervention + IVR|"Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)~Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages"
10807575|NCT01125371|FG001|Participant Flow|Computerized Brief Alcohol Intervention|"Computerized Brief Alcohol Intervention only (CBI)~Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time"
10807576|NCT01125371|FG002|Participant Flow|Attention Control|"Attention control~Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once"
10807577|NCT01125371|OG000|Outcome|Computerized Brief Alcohol Intervention + IVR|"Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)~Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages"
10807578|NCT01125371|OG001|Outcome|Computerized Brief Alcohol Intervention|"Computerized Brief Alcohol Intervention only (CBI)~Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time"
10807579|NCT01125371|OG002|Outcome|Attention Control|"Attention control~Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once"
10807580|NCT01125371|EG000|Reported Event|Computerized Brief Alcohol Intervention + IVR|"Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)~Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages"
10807581|NCT01125371|EG001|Reported Event|Computerized Brief Alcohol Intervention|"Computerized Brief Alcohol Intervention only (CBI)~Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time"
10807582|NCT01125371|EG002|Reported Event|Attention Control|"Attention control~Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once"
10820803|NCT00062868|FG013|Participant Flow|LMP1/2 CTLs (ALCI) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10807583|NCT00400946|BG000|Baseline|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807584|NCT00400946|BG001|Baseline|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807585|NCT00400946|BG002|Baseline|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
10807586|NCT00400946|BG003|Baseline|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
10807587|NCT00400946|BG004|Baseline|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
10807588|NCT00400946|BG005|Baseline|Total|Total of all reporting groups
10807589|NCT00400946|FG000|Participant Flow|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
11205199|NCT02227108|BG000|Baseline|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
10807590|NCT00400946|FG001|Participant Flow|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807591|NCT00400946|FG002|Participant Flow|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
10807592|NCT00400946|FG003|Participant Flow|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
10807593|NCT00400946|FG004|Participant Flow|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
10807594|NCT00400946|OG000|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807595|NCT00400946|OG001|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807596|NCT00400946|OG000|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
10807597|NCT00400946|OG000|Outcome|Low Day 32 MRD Level|Low end-induction (day 32) minimal residual disease (MRD) evaluated was defined as <0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods.
10807598|NCT00400946|OG001|Outcome|High Day 32 MRD Level|High end-induction (day 32) minimal residual disease (MRD) evaluated was defined as >/=0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods
10807599|NCT00400946|OG000|Outcome|M1 Day 18 Bone Marrow Status|M1 marrow morphology at day 18 was defined as <5% blasts.
10807600|NCT00400946|OG001|Outcome|M2/M3 Day 18 Bone Marrow Status|M2 marrow morphology at day 18 was defined as 5-24% blasts. M3 marrow morphology at day 18 was defined as >25% blasts.
10807601|NCT00400946|OG002|Outcome|Hypocellular Day 18 Bone Marrow Status|Hypocellular marrow morphology at day 18 was defined as empty blasts.
10807602|NCT00400946|OG000|Outcome|CNS-1|CNS-1: no blast cells in cytospin, regardless of cerebrospinal fluid (CSF) count
10807603|NCT00400946|OG001|Outcome|CNS-2|CNS-2: 5 or fewer WBC on CSF cell count, with blasts on cytospin
10807604|NCT00400946|OG002|Outcome|CNS-3|CNS-3: more than 5 WBC on CSF cell count, with blasts on cytospin
10807605|NCT00400946|OG003|Outcome|Traumatic Tap With Blasts|Traumatic Tap with Blasts: with blast cells and >100 RBCs on a wet prep
10807606|NCT00400946|OG004|Outcome|Traumatic Tap Without Blasts|Traumatic Tap without Blasts: without blast cells and >100 RBCs on a wet prep
10807607|NCT00400946|EG000|Reported Event|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807608|NCT00400946|EG001|Reported Event|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
10807609|NCT00400946|EG002|Reported Event|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
10807610|NCT00180414|BG000|Baseline|Ventricular Rate Regulation Feature ON|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807611|NCT00180414|BG001|Baseline|Ventricular Rate Regulation Feature OFF|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807612|NCT00180414|BG002|Baseline|Total|Total of all reporting groups
10807613|NCT00180414|FG000|Participant Flow|Ventricular Rate Regulation Feature ON|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807614|NCT00180414|FG001|Participant Flow|Ventricular Rate Regulation Feature OFF|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807615|NCT00180414|OG000|Outcome|Ventricular Rate Regulation Feature ON|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807616|NCT00180414|OG001|Outcome|Ventricular Rate Regulation Feature OFF|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807617|NCT00180414|EG000|Reported Event|Ventricular Rate Regulation Feature ON|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10807618|NCT00180414|EG001|Reported Event|Ventricular Rate Regulation Feature OFF|CRT devices with ventricular rate regulation [VRR] (CE labeled)
10820804|NCT00062868|FG014|Participant Flow|LMP1/2 CTLs (ALCI) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820805|NCT00062868|FG015|Participant Flow|LMP1/2 CTLs (ALCI) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820806|NCT00062868|FG016|Participant Flow|LMP1/2 CTLs (ALCI) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820807|NCT00062868|FG017|Participant Flow|LMP1/2 CTLs (ALCI) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820808|NCT00062868|FG018|Participant Flow|LMP1/2 CTLs (ALCI) - Group A Expansion|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820809|NCT00062868|FG019|Participant Flow|LMP1/2 CTLs (ALCI) - Group B Expansion|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820810|NCT00062868|FG020|Participant Flow|LMP1/2 CTLs (ALCI) - Group C Expansion|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10807619|NCT04061915|BG000|Baseline|Infographic Intervention|"Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic.~Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text."
10807620|NCT04061915|BG001|Baseline|Control|"Participants randomized to the control arm will text-based HIV self-testing instructions.~Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information."
10807621|NCT04061915|BG002|Baseline|Total|Total of all reporting groups
10807622|NCT04061915|FG000|Participant Flow|Infographic Intervention|"Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic.~Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text."
10807623|NCT04061915|FG001|Participant Flow|Control|"Participants randomized to the control arm will text-based HIV self-testing instructions.~Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information."
10807624|NCT04061915|OG000|Outcome|Infographic Intervention|"Emerging adults randomized to the online intervention arm will review the self-testing infographic. Once participants finish reviewing, they will answer comprehension and preference questions about the self-testing infographic.~Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model collaboratively designed by a leadership group of HIV community members"
10807625|NCT04061915|OG001|Outcome|Control|"Emerging adults randomized to the online control arm will read paper-based HIV self-testing information.~Paper-based HIV self-testing information: The online control arm will consist of paper-based, HIV self-testing information that the emerging adults will read."
10807626|NCT04061915|OG000|Outcome|Infographic Intervention|"Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic.~Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text."
10807627|NCT04061915|EG000|Reported Event|Infographic Intervention|"Participants randomized to the online intervention arm will review the HIV self-testing infographic. Once reviewed, participants will answer comprehension and preference questions about the self-testing infographic.~Infographic Intervention: A HIV self-testing infographic that utilizes a simplicity model of pictures with limited text."
10807628|NCT04061915|EG001|Reported Event|Control|"Participants randomized to the control arm will text-based HIV self-testing instructions.~Text-based HIV self-testing information: The online control arm will consist of text-based, HIV self-testing information."
10807629|NCT03990766|BG000|Baseline|Theophylline Saline Irrigation|"Theophylline 12 mg capsule contents dissolved into a sinus rinse bottle containing distilled or boiled tap water and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets, delivered to the bilateral nasal cavities twice daily.~Theophylline: Theophylline delivered via high-volume, low-pressure nasal saline irrigation"
10807630|NCT03990766|BG001|Baseline|Placebo Saline Irrigation|"Identical-appearing lactose monohydrate capsule contents dissolved into a sinus rinse bottle containing distilled or boiled tap water and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets, delivered to the bilateral nasal cavities twice daily.~Saline Nasal: Lactose delivered via high-volume, low-pressure nasal saline irrigation"
10807631|NCT03990766|BG002|Baseline|Total|Total of all reporting groups
10807632|NCT03990766|FG000|Participant Flow|Theophylline|12 mg of theophylline dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807633|NCT03990766|FG001|Participant Flow|Placebo|Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807634|NCT03990766|OG000|Outcome|Theophylline|12 mg of theophylline dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807635|NCT03990766|OG001|Outcome|Placebo|Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807636|NCT03990766|EG000|Reported Event|Theophylline|12 mg of theophylline dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807637|NCT03990766|EG001|Reported Event|Placebo|Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks
10807638|NCT03947333|BG000|Baseline|Intervention|"Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.~My Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."
10807639|NCT03947333|BG001|Baseline|Control|Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).
10807640|NCT03947333|BG002|Baseline|Total|Total of all reporting groups
10807641|NCT03947333|FG000|Participant Flow|Intervention|"Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.~My Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."
10807642|NCT03947333|FG001|Participant Flow|Control|Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).
10807643|NCT03947333|OG000|Outcome|Intervention|"Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.~My Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."
10807644|NCT03947333|OG001|Outcome|Control|Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).
10807645|NCT03947333|OG000|Outcome|Control|Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).
10807646|NCT03947333|EG000|Reported Event|Intervention|"Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.~My Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."
11205200|NCT02227108|FG000|Participant Flow|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
11205201|NCT02227108|OG000|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
11205202|NCT02227108|EG000|Reported Event|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
11205203|NCT02227121|BG000|Baseline|Enrolled Subjects|All subjects consented for the study.
11205204|NCT02227121|FG000|Participant Flow|Enrolled Subjects|All subjects consented for the study.
11205205|NCT02227121|OG000|Outcome|VF Induction and Defibrillation|"Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.~Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator."
11205206|NCT02227121|EG000|Reported Event|Enrolled Subjects|All subjects consented into the study
11205207|NCT02227316|BG000|Baseline|Intravenous Ibuprofen|"Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.~IV Ibuprofen"
11205208|NCT02227316|BG001|Baseline|Intravenous Acetaminophen|"Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4~IV Acetaminophen"
11205209|NCT02227316|BG002|Baseline|IV Ibuprofen/IV Acetaminophen|"Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4~IV Ibuprofen~IV Acetaminophen"
11205210|NCT02227316|BG003|Baseline|Intravenous Placebo/Intravenous Placebo|"Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4~IV Placebo"
11205211|NCT02227316|BG004|Baseline|Total|Total of all reporting groups
11205212|NCT02227316|FG000|Participant Flow|Intravenous Ibuprofen|"Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.~IV Ibuprofen"
11205213|NCT02227316|FG001|Participant Flow|Intravenous Acetaminophen|"Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4~IV Acetaminophen"
11205214|NCT02227316|FG002|Participant Flow|IV Ibuprofen/IV Acetaminophen|"Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4~IV Ibuprofen~IV Acetaminophen"
11205215|NCT02227316|FG003|Participant Flow|Intravenous Placebo/Intravenous Placebo|"Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4~IV Placebo"
11205216|NCT02227316|OG000|Outcome|Intravenous Ibuprofen|"Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.~IV Ibuprofen"
11205217|NCT02227316|OG001|Outcome|Intravenous Acetaminophen|"Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4~IV Acetaminophen"
11205218|NCT02227316|OG002|Outcome|IV Ibuprofen/IV Acetaminophen|"Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4~IV Ibuprofen~IV Acetaminophen"
11205219|NCT02227316|OG003|Outcome|Intravenous Placebo/Intravenous Placebo|"Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4~IV Placebo"
11205220|NCT02227316|EG000|Reported Event|Intravenous Ibuprofen|"Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.~IV Ibuprofen"
11205221|NCT02227316|EG001|Reported Event|Intravenous Acetaminophen|"Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4~IV Acetaminophen"
11205222|NCT02227316|EG002|Reported Event|IV Ibuprofen/IV Acetaminophen|"Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4~IV Ibuprofen~IV Acetaminophen"
11205223|NCT02227316|EG003|Reported Event|Intravenous Placebo/Intravenous Placebo|"Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4~IV Placebo"
11205224|NCT02227329|BG000|Baseline|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
11205225|NCT02227329|BG001|Baseline|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
11205226|NCT02227329|BG002|Baseline|Total|Total of all reporting groups
11205227|NCT02227329|FG000|Participant Flow|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
11205228|NCT02227329|FG001|Participant Flow|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
11205229|NCT02227329|OG000|Outcome|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
11205230|NCT02227329|OG001|Outcome|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
11205231|NCT02227329|EG000|Reported Event|Ethanol Lock and Normal Saline|All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
11205232|NCT02227329|EG001|Reported Event|Heparin and Normal Saline|All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
11205233|NCT02227368|BG000|Baseline|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
11205234|NCT02227368|BG001|Baseline|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
11205235|NCT02227368|BG002|Baseline|Total|Total of all reporting groups
11205236|NCT02227368|FG000|Participant Flow|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
11205237|NCT02227368|FG001|Participant Flow|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
11205238|NCT02227368|OG000|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
11205239|NCT02227368|OG001|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
11205240|NCT02227368|EG000|Reported Event|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
11205241|NCT02227368|EG001|Reported Event|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
11205242|NCT02227446|BG000|Baseline|Vancomycin Antibiotic Powder|"Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.~In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.~Vancomycin antibiotic powder: At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure."
11205243|NCT02227446|BG001|Baseline|Standard of Care|Participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Participants in this group will not receive local Vancomycin antibiotic powder.
11205244|NCT02227446|BG002|Baseline|Total|Total of all reporting groups
11205245|NCT02227446|FG000|Participant Flow|Control|Participants randomized to the control arm received standard infection prevention protocol without 1000 mg of intrawound vancomycin powder.
11205246|NCT02227446|FG001|Participant Flow|Vancomycin Powder|Participants randomized to the intervention arm received standard infection prevention protocol with 1000 mg of intrawound vancomycin powder.
11205247|NCT02227446|OG000|Outcome|Vancomycin Antibotic Powder|"Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.~In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.~Vancomycin antibiotic powder: At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure."
11205248|NCT02227446|OG001|Outcome|Standard of Care|Participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Participants in this group will not receive local Vancomycin antibiotic powder.
11205249|NCT02227446|EG000|Reported Event|Control|Participants randomized to the control arm received standard infection prevention protocol without 1000 mg of intrawound vancomycin powder.
11205250|NCT02227446|EG001|Reported Event|Vancomycin Powder|Participants randomized to the intervention arm received standard infection prevention protocol with 1000 mg of intrawound vancomycin powder.
11205251|NCT02227485|BG000|Baseline|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205252|NCT02227485|BG001|Baseline|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205253|NCT02227485|BG002|Baseline|Total|Total of all reporting groups
11205254|NCT02227485|FG000|Participant Flow|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205255|NCT02227485|FG001|Participant Flow|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205256|NCT02227485|OG000|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205257|NCT02227485|OG001|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205258|NCT02227485|OG000|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205259|NCT02227485|EG000|Reported Event|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205260|NCT02227485|EG001|Reported Event|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
11205261|NCT02227667|BG000|Baseline|Patients With Advanced Colorectal Cancer|"This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.~MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit."
11205262|NCT02227667|FG000|Participant Flow|Patients With Advanced Colorectal Cancer|"This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.~MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit."
11205263|NCT02227667|OG000|Outcome|Patients With Advanced Colorectal Cancer|"This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.~MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit."
11205264|NCT02227667|EG000|Reported Event|Patients With Advanced Colorectal Cancer|"This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.~MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit."
11205265|NCT02227693|BG000|Baseline|Placebo (60 mg)|Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205266|NCT02227693|BG001|Baseline|Avatrombopag (20 mg)|Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205267|NCT02227693|BG002|Baseline|Avatrombopag (40 mg)|Avatrombopag (40 mg), Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
11205268|NCT02227693|BG003|Baseline|Avatrombopag (60 mg)|Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
11205269|NCT02227693|BG004|Baseline|Total|Total of all reporting groups
11205270|NCT02227693|FG000|Participant Flow|Placebo (60 mg)|Participants took 60 milligrams (mg) placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205271|NCT02227693|FG001|Participant Flow|Avatrombopag (20 mg)|Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205272|NCT02227693|FG002|Participant Flow|Avatrombopag (40 mg)|Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
11205273|NCT02227693|FG003|Participant Flow|Avatrombopag (60 mg)|Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
11205274|NCT02227693|OG000|Outcome|Placebo (60 mg)|Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205275|NCT02227693|OG001|Outcome|Avatrombopag (20 mg)|Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205276|NCT02227693|OG002|Outcome|Avatrombopag (40 mg)|Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
10807647|NCT03947333|EG001|Reported Event|Control|Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).
10807648|NCT03886220|BG000|Baseline|Placebo|Placebo QD
11205277|NCT02227693|OG003|Outcome|Avatrombopag (60 mg)|Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
11205278|NCT02227693|OG000|Outcome|Placebo|Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
11205279|NCT02227693|OG001|Outcome|Avatrombopag 20-mg|20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
11205280|NCT02227693|OG002|Outcome|Avatrombopag 40-mg|40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
11205281|NCT02227693|OG003|Outcome|Avatrombopag 60-mg|60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
11205282|NCT02227693|EG000|Reported Event|Placebo (60 mg)|Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205283|NCT02227693|EG001|Reported Event|Avatrombopag (20 mg)|Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
11205284|NCT02227693|EG002|Reported Event|Avatrombopag (40 mg)|Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
11205285|NCT02227693|EG003|Reported Event|Avatrombopag (60 mg)|Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
11205286|NCT02227706|BG000|Baseline|EVICEL®|EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
11205287|NCT02227706|BG001|Baseline|SURGICEL®|SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
11205288|NCT02227706|BG002|Baseline|Total|Total of all reporting groups
11205289|NCT02227706|FG000|Participant Flow|EVICEL®|EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
11205290|NCT02227706|FG001|Participant Flow|SURGICEL®|SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
11205291|NCT02227706|OG000|Outcome|EVICEL®|EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
11205292|NCT02227706|OG001|Outcome|SURGICEL®|SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
11205293|NCT02227706|EG000|Reported Event|EVICEL®|EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.
11205294|NCT02227706|EG001|Reported Event|SURGICEL®|SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.
11205295|NCT02227758|BG000|Baseline|Implanted Chronic Migraine Patients|Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
11205296|NCT02227758|FG000|Participant Flow|Implanted Chronic Migraine Patients|Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
11205297|NCT02227758|OG000|Outcome|Implanted Chronic Migraine Patients|Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
11205298|NCT02227758|OG000|Outcome|Midas Score Including 4 Outliers|Including outliers with a reported increase of 128%, 148%, 225% and 434% at 3 months.
11205299|NCT02227758|OG001|Outcome|Midas Score Excluding 4 Outliers|Excluding outliers with a reported increase of 128%,148%, 225%, 434%
11205300|NCT02227758|EG000|Reported Event|Implanted Chronic Migraine Patients|Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system who experienced a Serious Device related adverse event
11205301|NCT02227784|BG000|Baseline|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205302|NCT02227784|BG001|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205303|NCT02227784|BG002|Baseline|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205304|NCT02227784|BG003|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205305|NCT02227784|BG004|Baseline|Total|Total of all reporting groups
11205306|NCT02227784|FG000|Participant Flow|Atorvastatin + Evacetrapib|Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807649|NCT03886220|BG001|Baseline|Elagolix 150 mg|Elagolix 150 mg QD
10807650|NCT03886220|BG002|Baseline|Total|Total of all reporting groups
10807651|NCT03886220|FG000|Participant Flow|Placebo|Placebo once daily (QD)
10807652|NCT03886220|FG001|Participant Flow|Elagolix 150 mg|Elagolix 150 mg QD
10807653|NCT03886220|OG000|Outcome|Placebo|Placebo QD
10807654|NCT03886220|OG001|Outcome|Elagolix 150 mg|Elagolix 150 mg QD
10807655|NCT03886220|EG000|Reported Event|Placebo|Placebo QD
10807656|NCT03886220|EG001|Reported Event|Elagolix 150 mg|Elagolix 150 mg QD
10820811|NCT00062868|OG000|Outcome|LMP2A CTLs (ALASCER) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820812|NCT00062868|OG001|Outcome|LMP2A CTLs (ALASCER) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
11205307|NCT02227784|FG001|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205308|NCT02227784|FG002|Participant Flow|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10820813|NCT00062868|OG002|Outcome|LMP2A CTLs (ALASCER) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820814|NCT00062868|OG003|Outcome|LMP2A CTLs (ALASCER) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820815|NCT00062868|OG004|Outcome|LMP2A CTLs (ALASCER) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820816|NCT00062868|OG005|Outcome|LMP2A CTLs (ALASCER) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820817|NCT00062868|OG006|Outcome|LMP2A CTLs (ALASCER) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820818|NCT00062868|OG007|Outcome|LMP2A CTLs (ALASCER) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820819|NCT00062868|OG008|Outcome|LMP2A CTLs (ALASCER) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820820|NCT00062868|OG009|Outcome|LMP1/2 CTLs (ALCI) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820821|NCT00062868|OG010|Outcome|LMP1/2 CTLs (ALCI) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820822|NCT00062868|OG011|Outcome|LMP1/2 CTLs (ALCI) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820823|NCT00062868|OG012|Outcome|LMP1/2 CTLs (ALCI) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820824|NCT00062868|OG013|Outcome|LMP1/2 CTLs (ALCI) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820825|NCT00062868|OG014|Outcome|LMP1/2 CTLs (ALCI) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820826|NCT00062868|OG015|Outcome|LMP1/2 CTLs (ALCI) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820827|NCT00062868|OG016|Outcome|LMP1/2 CTLs (ALCI) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820828|NCT00062868|OG017|Outcome|LMP1/2 CTLs (ALCI) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
11205309|NCT02227784|FG003|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807657|NCT03800979|BG000|Baseline|Tofacitinib|"All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.~Tofacitinib is the Janus kinase inhibitor, which FDA has approved for Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss."
10807658|NCT03800979|FG000|Participant Flow|Tofacitinib|"All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.~Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss."
10807659|NCT03800979|OG000|Outcome|Tofacitinib|"All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.~Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss."
10807660|NCT03800979|EG000|Reported Event|Tofacitinib|"All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.~Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss."
10807661|NCT03794661|BG000|Baseline|Single Arm|"Clinician programmer electrode screening mode tool~Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process"
10807662|NCT03794661|FG000|Participant Flow|Single Arm|"Clinician programmer electrode screening mode tool~Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process"
10807663|NCT03794661|OG000|Outcome|Single Arm|"Clinician programmer electrode screening mode tool~Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process"
10807664|NCT03794661|EG000|Reported Event|Single Arm|"Clinician programmer electrode screening mode tool~Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process"
10807665|NCT03691909|BG000|Baseline|Treatment Arm|Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
10807666|NCT03691909|FG000|Participant Flow|Treatment Arm|Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs).
10807667|NCT03691909|OG000|Outcome|Treatment Arm|Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
10807668|NCT03691909|OG000|Outcome|Treatment Arm|Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
10807669|NCT03691909|EG000|Reported Event|Treatment Arm|Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
10807670|NCT03627091|BG000|Baseline|Placebo|Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807671|NCT03627091|BG001|Baseline|Ontamalimab 25 mg|Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807672|NCT03627091|BG002|Baseline|Experimental: Ontamalimab 75 mg|Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807673|NCT03627091|BG003|Baseline|Total|Total of all reporting groups
10807674|NCT03627091|FG000|Participant Flow|Placebo|Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807675|NCT03627091|FG001|Participant Flow|Ontamalimab 25 mg|Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807676|NCT03627091|FG002|Participant Flow|Ontamalimab 75 mg|Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807677|NCT03627091|OG000|Outcome|Placebo|Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807678|NCT03627091|OG001|Outcome|Ontamalimab 25 mg|Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807679|NCT03627091|OG002|Outcome|Ontamalimab 75 mg|Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807680|NCT03627091|OG001|Outcome|Ontamalimab 25 mg|Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks
11205310|NCT02227784|FG004|Participant Flow|Atorvastatin + Evacetrapib Open-Label (OLE)|Open label extension (OLE) (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807681|NCT03627091|EG000|Reported Event|Placebo|Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807682|NCT03627091|EG001|Reported Event|Ontamalimab 25 mg|Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10807683|NCT03627091|EG002|Reported Event|Ontamalimab 75 mg|Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) once every 4 weeks for up to 52 weeks.
10820829|NCT00062868|OG018|Outcome|LMP1/2 CTLs (ALCI) - Group A Expansion|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820830|NCT00062868|OG019|Outcome|LMP1/2 CTLs (ALCI) - Group B Expansion|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820831|NCT00062868|OG020|Outcome|LMP1/2 CTLs (ALCI) - Group C Expansion|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820832|NCT00062868|EG000|Reported Event|LMP2A CTLs (ALASCER) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820833|NCT00062868|EG001|Reported Event|LMP2A CTLs (ALASCER) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820834|NCT00062868|EG002|Reported Event|LMP2A CTLs (ALASCER) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820835|NCT00062868|EG003|Reported Event|LMP2A CTLs (ALASCER) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
11205311|NCT02227784|OG000|Outcome|Atorvastatin + Evacetrapib|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10820836|NCT00062868|EG004|Reported Event|LMP2A CTLs (ALASCER) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820837|NCT00062868|EG005|Reported Event|LMP2A CTLs (ALASCER) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820838|NCT00062868|EG006|Reported Event|LMP2A CTLs (ALASCER) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820839|NCT00062868|EG007|Reported Event|LMP2A CTLs (ALASCER) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820840|NCT00062868|EG008|Reported Event|LMP2A CTLs (ALASCER) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820841|NCT00062868|EG009|Reported Event|LMP1/2 CTLs (ALCI) - Group A DL1|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820842|NCT00062868|EG010|Reported Event|LMP1/2 CTLs (ALCI) - Group A DL2|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820843|NCT00062868|EG011|Reported Event|LMP1/2 CTLs (ALCI) - Group A DL3|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820844|NCT00062868|EG012|Reported Event|LMP1/2 CTLs (ALCI) - Group B DL1|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820845|NCT00062868|EG013|Reported Event|LMP1/2 CTLs (ALCI) - Group B DL2|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10820846|NCT00062868|EG014|Reported Event|LMP1/2 CTLs (ALCI) - Group B DL3|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10820847|NCT00062868|EG015|Reported Event|LMP1/2 CTLs (ALCI) - Group C DL1|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820848|NCT00062868|EG016|Reported Event|LMP1/2 CTLs (ALCI) - Group C DL2|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2)."
10807684|NCT03568318|BG000|Baseline|Adults: Placebo + Topical Corticosteroids|Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807685|NCT03568318|BG001|Baseline|Adults: Upadacitinib 15 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807686|NCT03568318|BG002|Baseline|Adults: Upadacitinib 30 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807687|NCT03568318|BG003|Baseline|Adolescents: Placebo + Topical Corticosteroids|Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807688|NCT03568318|BG004|Baseline|Adolescents: Upadacitinib 15 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807689|NCT03568318|BG005|Baseline|Adolescents: Upadacitinib 30 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807690|NCT03568318|BG006|Baseline|Total|Total of all reporting groups
10807691|NCT03568318|FG000|Participant Flow|Adults: Placebo + Topical Corticosteroids|Participants ≥ 18 years old received placebo orally once a day (QD) and topical corticosteroids (TCS) following a step-down regimen for 16 weeks in the double-blind treatment period.
10807692|NCT03568318|FG001|Participant Flow|Adults: Upadacitinib 15 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807693|NCT03568318|FG002|Participant Flow|Adults: Upadacitinib 30 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807694|NCT03568318|FG003|Participant Flow|Adolescents: Placebo + Topical Corticosteroids|Adolescent participants (12 - 17 years old) received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807695|NCT03568318|FG004|Participant Flow|Adolescents: Upadacitinib 15 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807696|NCT03568318|FG005|Participant Flow|Adolescents: Upadacitinib 30 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807697|NCT03568318|OG000|Outcome|Placebo + Topical Corticosteroids|Participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807698|NCT03568318|OG001|Outcome|Upadacitinib 15 mg + Topical Corticosteroids|Participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807699|NCT03568318|OG002|Outcome|Upadacitinib 30 mg + Topical Corticosteroids|Participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807700|NCT03568318|OG000|Outcome|Adolescents: Placebo + Topical Corticosteroids|Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807701|NCT03568318|OG001|Outcome|Adolescents: Upadacitinib 15 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807702|NCT03568318|OG002|Outcome|Adolescents: Upadacitinib 30 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807703|NCT03568318|EG000|Reported Event|Adults: Placebo + Topical Corticosteroids|Participants ≥ 18 years old received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807704|NCT03568318|EG001|Reported Event|Adults: Upadacitinib 15 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807705|NCT03568318|EG002|Reported Event|Adults: Upadacitinib 30 mg + Topical Corticosteroids|Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807706|NCT03568318|EG003|Reported Event|Adolescents: Placebo + Topical Corticosteroids|Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807707|NCT03568318|EG004|Reported Event|Adolescents: Upadacitinib 15 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807708|NCT03568318|EG005|Reported Event|Adolescents: Upadacitinib 30 mg + Topical Corticosteroids|Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period.
10807709|NCT03498560|BG000|Baseline|MGH Surgery Patients|"PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.~PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance."
10807710|NCT03498560|FG000|Participant Flow|MGH Surgery Patients|"PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.~PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance."
10807711|NCT03498560|OG000|Outcome|MGH Surgery Patients|"PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.~PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance."
10807712|NCT03498560|OG000|Outcome|MGH Surgery Patients|"PSG and EEG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.~PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance. EEG data to be collected in the Operating room during surgery."
10807713|NCT03498560|EG000|Reported Event|MGH Surgery Patients|"PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.~PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance."
10807714|NCT03441360|BG000|Baseline|Eribulin Mesylate 1.4 mg/m^2: RMS|Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807715|NCT03441360|BG001|Baseline|Eribulin Mesylate 1.4 mg/m^2: NRSTS|Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807716|NCT03441360|BG002|Baseline|Eribulin Mesylate 1.4 mg/m^2: EWS|Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807717|NCT03441360|BG003|Baseline|Total|Total of all reporting groups
10807718|NCT03441360|FG000|Participant Flow|Eribulin Mesylate 1.4 mg/m^2: RMS|Pediatric participants with rhabdomyosarcoma (RMS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m^2). Participants continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807719|NCT03441360|FG001|Participant Flow|Eribulin Mesylate 1.4 mg/m^2: NRSTS|Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807720|NCT03441360|FG002|Participant Flow|Eribulin Mesylate 1.4 mg/m^2: EWS|Pediatric participants with Ewing sarcoma (EWS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807721|NCT03441360|OG000|Outcome|Eribulin Mesylate 1.4 mg/m^2: RMS|Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807722|NCT03441360|OG001|Outcome|Eribulin Mesylate 1.4 mg/m^2: NRSTS|Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807723|NCT03441360|OG002|Outcome|Eribulin Mesylate 1.4 mg/m^2: EWS|Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807724|NCT03441360|EG000|Reported Event|Eribulin Mesylate 1.4 mg/m^2: RMS|Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807725|NCT03441360|EG001|Reported Event|Eribulin Mesylate 1.4 mg/m^2: NRSTS|Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807726|NCT03441360|EG002|Reported Event|Eribulin Mesylate 1.4 mg/m^2: EWS|Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
10807727|NCT03434379|BG000|Baseline|Sorafenib - All|All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807728|NCT03434379|BG001|Baseline|Atezolizumab + Bevacizumab - All|All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807729|NCT03434379|BG002|Baseline|Total|Total of all reporting groups
10807730|NCT03434379|FG000|Participant Flow|Sorafenib - Global|Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807731|NCT03434379|FG001|Participant Flow|Atezolizumab + Bevacizumab - Global|Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807732|NCT03434379|FG002|Participant Flow|Sorafenib - China|Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807733|NCT03434379|FG003|Participant Flow|Atezolizumab + Bevacizumab - China|Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807734|NCT03434379|OG000|Outcome|Sorafenib - Global|Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807735|NCT03434379|OG001|Outcome|Atezolizumab + Bevacizumab - Global|Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807736|NCT03434379|OG000|Outcome|Sorafenib - China|Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807737|NCT03434379|OG001|Outcome|Atezolizumab + Bevacizumab - China|Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807738|NCT03434379|OG000|Outcome|Atezolizumab + Bevacizumab - Global|Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807739|NCT03434379|OG000|Outcome|Atezolizumab + Bevacizumab - China|Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807740|NCT03434379|EG000|Reported Event|Sorafenib - Global|Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807741|NCT03434379|EG001|Reported Event|Atezolizumab + Bevacizumab - Global|Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807742|NCT03434379|EG002|Reported Event|Sorafenib - China|Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807743|NCT03434379|EG003|Reported Event|Atezolizumab + Bevacizumab - China|Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
10807744|NCT03368170|BG000|Baseline|Mesdopetam|Mesdopetam (IRL790): 2.5 mg white hard HPMC capsule, oral administration
10807745|NCT03368170|BG001|Baseline|Placebo|Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
10807746|NCT03368170|BG002|Baseline|Total|Total of all reporting groups
10807747|NCT03368170|FG000|Participant Flow|Mesdopetam|Mesdopetam capsule, 2.5 mg oral administration. Dose given twice daily (5 mg, 7.5 mg or 10 mg b.i.d.) The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated predefined dose, after which patients continued on this highest per patient tolerated dose for an additional two weeks.
10807748|NCT03368170|FG001|Participant Flow|Placebo|"Matching placebo capsule, oral administration. Dose given twice daily.~The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated number of placebo capsules (1 capsule x 4), after which patients continued on this highest tolerated dose for an additional two weeks."
10807749|NCT03368170|OG000|Outcome|Mesdopetam|Mesdopetam: 2.5 mg white hard HPMC capsule, oral administration
11205312|NCT02227784|OG001|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807750|NCT03368170|OG001|Outcome|Placebo|Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
10807751|NCT03368170|EG000|Reported Event|Mesdopetam|Mesdopetam (IRL790): 2.5 mg white hard HPMC capsule, oral administration
10807752|NCT03368170|EG001|Reported Event|Placebo|Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
10807753|NCT03336528|BG000|Baseline|Degludec|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.
10807754|NCT03336528|BG001|Baseline|Glargine|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.
10807755|NCT03336528|BG002|Baseline|Total|Total of all reporting groups
10807756|NCT03336528|FG000|Participant Flow|Degludec|"Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.~Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Participants were treated with an insulin regimen of half of TDD given a as basal insulin once daily and half as aspart divided in three equal doses before meals. Insulin dosage was adjusted daily to maintain a fasting and pre-dinner blood glucose between 100 and 180 mg/dL."
10807757|NCT03336528|FG001|Participant Flow|Glargine|"Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.~Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Participants were treated with an insulin regimen of half of TDD given as basal once daily and half as aspart divided in three equal doses before meals. Insulin dosage was adjusted daily to maintain a fasting and pre-dinner blood glucose between 100 and 180 mg/dL."
10807758|NCT03336528|OG000|Outcome|Degludec|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.
10807759|NCT03336528|OG001|Outcome|Glargine|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.
10807760|NCT03336528|OG000|Outcome|Degludec During Hospitalization|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.
10807761|NCT03336528|OG001|Outcome|Glargine During Hospitalization|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.
10807762|NCT03336528|EG000|Reported Event|Degludec|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.
10807763|NCT03336528|EG001|Reported Event|Glargine|Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.
10807764|NCT03334409|BG000|Baseline|Arm A (Pazopanib Hydrochloride, Ascorbic Acid)|Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807765|NCT03334409|BG001|Baseline|Arm B (Pazopanib Hydrochloride)|Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807766|NCT03334409|BG002|Baseline|Total|Total of all reporting groups
10807767|NCT03334409|FG000|Participant Flow|Arm A (Pazopanib Hydrochloride, Ascorbic Acid)|Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807768|NCT03334409|FG001|Participant Flow|Arm B (Pazopanib Hydrochloride)|Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807769|NCT03334409|OG000|Outcome|Arm A (Pazopanib Hydrochloride, Ascorbic Acid)|Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807770|NCT03334409|OG001|Outcome|Arm B (Pazopanib Hydrochloride)|Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807771|NCT03334409|EG000|Reported Event|Arm A (Pazopanib Hydrochloride, Ascorbic Acid)|Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807772|NCT03334409|EG001|Reported Event|Arm B (Pazopanib Hydrochloride)|Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
10807773|NCT03287843|BG000|Baseline|Classic Interval Group|"İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection"
10807774|NCT03287843|BG001|Baseline|Long Interval Group|"İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection"
10807775|NCT03287843|BG002|Baseline|Total|Total of all reporting groups
10807776|NCT03287843|FG000|Participant Flow|Classic Interval Group|"İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection"
11205313|NCT02227784|OG002|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807777|NCT03287843|FG001|Participant Flow|Long Interval Group|"İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection"
10807778|NCT03287843|OG000|Outcome|Classic Interval Group|"İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection"
10807779|NCT03287843|OG001|Outcome|Long Interval Group|"İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection"
10807780|NCT03287843|EG000|Reported Event|Classic Interval Group|"İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection"
10807781|NCT03287843|EG001|Reported Event|Long Interval Group|"İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.~Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection"
10807782|NCT03230292|BG000|Baseline|BKZ All Participants|Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
10820849|NCT00062868|EG017|Reported Event|LMP1/2 CTLs (ALCI) - Group C DL3|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2)."
10807783|NCT03230292|FG000|Participant Flow|BKZ All Participants|Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
10807784|NCT03230292|OG000|Outcome|BKZ All Participants (SS)|Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
10807785|NCT03230292|OG000|Outcome|BKZ All Participants (PK-PPS)|Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Pharmacokinetic-Per Protocol Set (PK-PPS).
10807786|NCT03230292|OG000|Outcome|BKZ All Participants (FAS)|Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
10807787|NCT03230292|EG000|Reported Event|BKZ All Participants (SS)|Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
10820850|NCT00062868|EG018|Reported Event|LMP1/2 CTLs (ALCI) - Group A Expansion|"Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820851|NCT00062868|EG019|Reported Event|LMP1/2 CTLs (ALCI) - Group B Expansion|"Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820852|NCT00062868|EG020|Reported Event|LMP1/2 CTLs (ALCI) - Group C Expansion|"Group C: Participants receiving CTLs following allogeneic stem cell transplant.~Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2)."
10820853|NCT00063154|BG000|Baseline|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
10807801|NCT03131960|BG000|Baseline|VNS + Rehabilitation (1)|"Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.~Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807802|NCT03131960|BG001|Baseline|Control VNS|"Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807803|NCT03131960|BG002|Baseline|Total|Total of all reporting groups
10807804|NCT03131960|FG000|Participant Flow|VNS + Rehabilitation (1)|"Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.~Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807805|NCT03131960|FG001|Participant Flow|Control VNS|"Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807806|NCT03131960|OG000|Outcome|VNS + Rehabilitation (1)|"Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.~Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807807|NCT03131960|OG001|Outcome|Control VNS|"Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807808|NCT03131960|EG000|Reported Event|VNS + Rehabilitation (1)|"Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.~Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807809|NCT03131960|EG001|Reported Event|Control VNS|"Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.~Rehabilitation: Rehabilitation movements to improve upper limb function after stroke"
10807810|NCT03084536|BG000|Baseline|Preoperative PECS Blocks|"PECS I & II block will be administered preoperatively~For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)~To ensure blind integrity, study drug syringes will be marked only study drug and subject number~Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist"
10807811|NCT03084536|BG001|Baseline|Placebo PECS Blocks|"A sham block (normal saline) will be placed preoperatively~To ensure blind integrity, study drug syringes will be marked only study drug and subject number.~Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist."
10807812|NCT03084536|BG002|Baseline|Not Randomized to an Arm|-Participants were removed from the study prior to being randomized into an Arm.
10807813|NCT03084536|BG003|Baseline|Total|Total of all reporting groups
10807814|NCT03084536|FG000|Participant Flow|Preoperative PECS Blocks|"PECS I & II block will be administered preoperatively~For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)~To ensure blind integrity, study drug syringes will be marked only study drug and subject number~Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist"
10807815|NCT03084536|FG001|Participant Flow|Placebo PECS Blocks|"A sham block (normal saline) will be placed preoperatively~To ensure blind integrity, study drug syringes will be marked only study drug and subject number.~Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist."
10807816|NCT03084536|FG002|Participant Flow|Not Randomized to an Arm|-Participants were removed from the study prior to being randomized into an Arm.
10807817|NCT03084536|OG000|Outcome|Preoperative PECS Blocks|"PECS I & II block will be administered preoperatively~For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)~To ensure blind integrity, study drug syringes will be marked only study drug and subject number~Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist"
10807818|NCT03084536|OG001|Outcome|Placebo PECS Blocks|"A sham block (normal saline) will be placed preoperatively~To ensure blind integrity, study drug syringes will be marked only study drug and subject number.~Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist."
10807819|NCT03084536|EG000|Reported Event|Preoperative PECS Blocks|"PECS I & II block will be administered preoperatively~For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)~To ensure blind integrity, study drug syringes will be marked only study drug and subject number~Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist"
10807820|NCT03084536|EG001|Reported Event|Placebo PECS Blocks|"A sham block (normal saline) will be placed preoperatively~To ensure blind integrity, study drug syringes will be marked only study drug and subject number.~Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist."
10807821|NCT03084536|EG002|Reported Event|Not Randomized to an Arm|-Participants were removed from the study prior to being randomized into an Arm and did not receive any treatment on the study.
10807822|NCT02996305|BG000|Baseline|Placebo|Placebo BID Evening and Morning
10807823|NCT02996305|BG001|Baseline|OV101 QD|OV101 15 mg Evening Placebo in the Morning
10807824|NCT02996305|BG002|Baseline|OV101 BID|OV101 15 mg Evening OV101 10 mg Morning
10807825|NCT02996305|BG003|Baseline|Total|Total of all reporting groups
10807826|NCT02996305|FG000|Participant Flow|Placebo|Giving twice daily
10807827|NCT02996305|FG001|Participant Flow|OV101 QD|OV101, once daily (15mg night)
10807828|NCT02996305|FG002|Participant Flow|OV101 BID|OV101, twice daily (10mg morning, 15mg night)
10807829|NCT02996305|OG000|Outcome|Placebo|Twice daily
10807830|NCT02996305|OG001|Outcome|OV101 QD|OV101, once daily (15mg night)
10807831|NCT02996305|OG002|Outcome|OV101 BID|OV101, twice daily (10mg morning, 15mg night)
10807832|NCT02996305|EG000|Reported Event|Placebo|Placebo Morning and Evening
10807833|NCT02996305|EG001|Reported Event|OV101 QD|OV101 15mg Evening
10807834|NCT02996305|EG002|Reported Event|OV101 BID|OV101 15 mg Evening OV101 10 mg Morning
10807835|NCT02992119|BG000|Baseline|Group 1|"RTS,S/AS01B Fractional dose~RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2."
10807836|NCT02992119|BG001|Baseline|Group 2|"Double RTS,S/AS01E Fractional dose~Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807837|NCT02992119|BG002|Baseline|Group 3|"RTS,S/AS01E Standard dose~RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2."
10807838|NCT02992119|BG003|Baseline|Group 4|"RTS,S/AS01E + DHA-PIP+PQ Standard dose~RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2"
10807839|NCT02992119|BG004|Baseline|Group 5|"RTS,S/AS01E Fractional dose~RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807840|NCT02992119|BG005|Baseline|Group 6|"RTS,S/AS01E + DHA-PIP+PQ Fractional dose~RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2."
10807841|NCT02992119|BG006|Baseline|Group 7|"RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose~RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2"
10807842|NCT02992119|BG007|Baseline|Total|Total of all reporting groups
10807843|NCT02992119|FG000|Participant Flow|Group 1 RTS,S/AS01B Fractional Dose|"RTS,S/AS01B Fractional dose~RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2."
10807844|NCT02992119|FG001|Participant Flow|Group 2 Double RTS,S/AS01E Fractional Dose|"Double RTS,S/AS01E Fractional dose~Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807845|NCT02992119|FG002|Participant Flow|Group 3 RTS,S/AS01E Standard Dose|"RTS,S/AS01E Standard dose~RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2."
10807846|NCT02992119|FG003|Participant Flow|Group 4 RTS,S/AS01E + DHA-PIP+PQ Standard Dose|"RTS,S/AS01E + DHA-PIP+PQ Standard dose~RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2"
10807847|NCT02992119|FG004|Participant Flow|Group 5 RTS,S/AS01E Fractional Dose|"RTS,S/AS01E Fractional dose~RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807848|NCT02992119|FG005|Participant Flow|Group 6 RTS,S/AS01E + DHA-PIP+PQ Fractional Dose|"RTS,S/AS01E + DHA-PIP+PQ Fractional dose~RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2."
10807849|NCT02992119|FG006|Participant Flow|Group 7 RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose|"RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose~RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2"
10807850|NCT02992119|OG000|Outcome|Group 1|"RTS,S/AS01B Fractional dose~RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2."
10807851|NCT02992119|OG001|Outcome|Group 2|"Double RTS,S/AS01E Fractional dose~Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807852|NCT02992119|OG002|Outcome|Group 3|"RTS,S/AS01E Standard dose~RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2."
10807853|NCT02992119|OG003|Outcome|Group 4|"RTS,S/AS01E + DHA-PIP+PQ Standard dose~RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2"
10807854|NCT02992119|OG004|Outcome|Group 5|"RTS,S/AS01E Fractional dose~RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807855|NCT02992119|OG005|Outcome|Group 6|"RTS,S/AS01E + DHA-PIP+PQ Fractional dose~RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2."
10807856|NCT02992119|OG006|Outcome|Group 7|"RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose~RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2"
10807857|NCT02992119|OG000|Outcome|Group 7|"RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose~RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2"
10807858|NCT02992119|EG000|Reported Event|Group 1|"RTS,S/AS01B Fractional dose~RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2."
10807859|NCT02992119|EG001|Reported Event|Group 2|"Double RTS,S/AS01E Fractional dose~Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807860|NCT02992119|EG002|Reported Event|Group 3|"RTS,S/AS01E Standard dose~RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2."
10807861|NCT02992119|EG003|Reported Event|Group 4|"RTS,S/AS01E + DHA-PIP+PQ Standard dose~RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2"
10807862|NCT02992119|EG004|Reported Event|Group 5|"RTS,S/AS01E Fractional dose~RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2."
10807863|NCT02992119|EG005|Reported Event|Group 6|"RTS,S/AS01E + DHA-PIP+PQ Fractional dose~RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2."
10807864|NCT02992119|EG006|Reported Event|Group 7|"RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose~RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2"
10807865|NCT02988661|BG000|Baseline|Chronic Disease Self-management Program (CDSMP)|A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.
10807866|NCT02988661|BG001|Baseline|Usual Care|African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
10807867|NCT02988661|BG002|Baseline|Total|Total of all reporting groups
10807868|NCT02988661|FG000|Participant Flow|Chronic Disease Self-management Program (CDSMP)|A random sample of African American women with systemic lupus erythematosus (SLE) selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the chronic disease self-management program (CDSMP). This group is identified as the Women Empowered to Live with Lupus (WELL) Cohort.
10807869|NCT02988661|FG001|Participant Flow|Usual Care|African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
10807870|NCT02988661|OG000|Outcome|Chronic Disease Self-management Program (CDSMP)|A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.
10807871|NCT02988661|OG001|Outcome|Usual Care|African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
10807872|NCT02988661|EG000|Reported Event|Chronic Disease Self-management Program (CDSMP)|A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.
10807873|NCT02988661|EG001|Reported Event|Usual Care|African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
10820854|NCT00063154|FG000|Participant Flow|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
10807878|NCT02921776|BG000|Baseline|Aim 1- VidaTalk Post-extubation|"Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC.~Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks.~Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions.~Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app:~Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task.~Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak.~Grp 1 only: will be asked their preferences for customizing the app."
10807879|NCT02921776|BG001|Baseline|Aim 2 - VidaTalk Intubated|"Usability testing preliminary to Clinical Trial. Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.~Intervention is usability tasks with the VidaTalk app~Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-"
10807880|NCT02921776|BG002|Baseline|Aim 3 - VidaTalk Tablet App|"Test the clinical efficacy of VidaTalk with MV patients by examining qualitative & quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.~Intervention will be receipt of VidaTalk tablet application.~Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration."
10807881|NCT02921776|BG003|Baseline|Aim 3 - Attention-control|"35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts.~Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.~Interventions will be Aim 3 - attention-control with non-VidaTalk tablet.~Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet."
10807882|NCT02921776|BG004|Baseline|Aim 5-VidaTalk Efficacy in Family Caregivers- VidaTalk Group|"Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively.~Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured."
10807883|NCT02921776|BG005|Baseline|Aim 5 Family Caregiver- Attention Control|Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log.
10807884|NCT02921776|BG006|Baseline|Total|Total of all reporting groups
10807885|NCT02921776|FG000|Participant Flow|Aim 1- VidaTalk Post-extubation|"Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 & 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUMC including discharged patients.~Group 1 will use an initial android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices.~Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions.~Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:~Tell me you are tired~Tell me you are having pain~Rate this pain~Tell me there is pain in your back~Tell me your pain is sharp~Ask to see"
10820855|NCT00063154|OG000|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
10807886|NCT02921776|FG001|Participant Flow|Aim 2 - VidaTalk Intubated|"Usability testing preliminary to Clinical Trial. Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.~Intervention is usability tasks with the VidaTalk app~Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-"
10807887|NCT02921776|FG002|Participant Flow|Nurse Focus Group - PreClinical Trial Phase|ICU nurses were recruited to participate in qualitative focus group interviews regarding their impressions of the VidaTalk tablet app for use with mechanically ventilated patients, their experience (if any) of using the app, and general perspectives about communicating with mechanically ventilated ICU patients. We also elicited suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care.
10807888|NCT02921776|FG003|Participant Flow|Aim 3 - VidaTalk Tablet App|"Test the clinical efficacy of VidaTalk with MV patients by examining qualitative & quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.~Intervention will be receipt of VidaTalk tablet application.~Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration."
10807889|NCT02921776|FG004|Participant Flow|Aim 3 - Attention-control|"35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts.~Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.~Interventions will be Aim 3 - attention-control with non-VidaTalk tablet.~Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet."
10807890|NCT02921776|FG005|Participant Flow|Nurse Focus Group - VidaTalk RCT|ICU Nurses who had experience with using the VidaTalk tablet app with mechanically ventilated patients were recruited to participate in focus group interviews to obtain their perspectives and experience on using the application as well as suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care.
10807891|NCT02921776|FG006|Participant Flow|Aim 5-VidaTalk Efficacy in Family Caregivers - VidaTalk Group|"Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively.~Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured.~VidaTalk (Intervention) Group receives brief introduction, instruction sheet and completes ICU bedside visitation log with dates and times of visits."
10807892|NCT02921776|FG007|Participant Flow|Aim 5 Family Caregiver - Attention Control|Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log.
10807893|NCT02921776|OG000|Outcome|Aim 1- VidaTalk Post-extubation|"Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC.~Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks.~Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions.~Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app:~Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task.~Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak.~Grp 1 only: will be asked their preferences for customizing the app."
10807894|NCT02921776|OG001|Outcome|Aim 2 - VidaTalk Intubated|"Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.~Intervention is usability tasks with the VidaTalk app~Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-"
10807895|NCT02921776|OG002|Outcome|Aim 3 - VidaTalk Tablet App|"Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed.~Intervention will be receipt of VidaTalk tablet application.~Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration."
10807896|NCT02921776|OG003|Outcome|Aim 3 - Attention-control|"35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts.~Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.~Interventions will be Aim 3 - attention-control with non-VidaTalk tablet.~Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet."
10807897|NCT02921776|OG004|Outcome|Aim 5-VidaTalk Efficacy in Family Caregivers|"Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively.~Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured."
10807898|NCT02921776|OG000|Outcome|Aim 1- VidaTalk Post-extubation|"Aim 1 - two group iterative design preliminary to clinical trial. Group 1/Group 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICU at the Ohio State University including discharged patients. Group 1 will use an android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices.Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:Tell me you are tired; Tell me you are having pain; Rate this pain; Tell me there is pain in your back; Tell me your pain is sharp; Ask to see the doctor; Write your favorite color by drawing with your finger; Type How are you?~Patients will also complete a 1-item difficulty rating and a 3-item After-Scenario Questionnaire (ASQ) after each task. Patients will also be asked to a) comment on the customization of the app and make suggestions; b) rate the extent to which they would use the device if they were an ICU patient and unable to speak. Group 1 only:~Patients will be asked about their preferences for customizing the VidaTalk app."
10807899|NCT02921776|OG001|Outcome|Aim 2 - VidaTalk Intubated|"Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.~Intervention is usability tasks with the VidaTalk app~Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS)."
10820856|NCT00063154|EG000|Reported Event|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
10820857|NCT00063232|BG000|Baseline|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
11205314|NCT02227784|OG003|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205315|NCT02227784|OG002|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205316|NCT02227784|OG003|Outcome|Atorvastatin 80 mg|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10807900|NCT02921776|OG002|Outcome|Aim 3 - VidaTalk Tablet App|"Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.~Intervention will be receipt of VidaTalk tablet application.~Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed."
10807901|NCT02921776|OG004|Outcome|Aim 5-VidaTalk Intervention for Family Members|Aim 5 - Vida Talk Intervention with Family Members
10807902|NCT02921776|OG005|Outcome|Aim-5 Control Group|Aim - 5 Control Group
10807903|NCT02921776|OG004|Outcome|Aim 5-VidaTalk Intervention for Family Members|Aim 5 - VidaTalk Intervention for Family Members
10807904|NCT02921776|OG005|Outcome|Aim-5 Control Group|Aim 5 - Control Group
10807905|NCT02921776|OG004|Outcome|Aim 5-VidaTalk Intervention in Family Members|Aim 5 - VidaTalk Intervention in family members
10807906|NCT02921776|EG000|Reported Event|Aim 1 - VidaTalk Post-Extubation|Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices.
10807907|NCT02921776|EG001|Reported Event|Aim 2 - VidaTalk Intubated|Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical setting.
10807908|NCT02921776|EG002|Reported Event|Aim 3 - VidaTalk Tablet App|Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application).
10807909|NCT02921776|EG003|Reported Event|Aim 3 - Attention Control|Intubated patients who did not receive the VidaTalk Intervention
10807910|NCT02921776|EG004|Reported Event|Aim 4|Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale.
10807911|NCT02921776|EG005|Reported Event|Aim 5 - VidaTalk Efficacy in Family Caregivers - VidaTalk Group|Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.
10807912|NCT02921776|EG006|Reported Event|Aim 5 - Family Caregiver Attention Control|Family members of patients who did not receive the VidaTalk Intervention
10807913|NCT02921776|EG007|Reported Event|Nurse Focus Group - PreClinical Trial Phase|Focus group of ICU nurses on how to implement the VidaTalk Intervention
10807914|NCT02921776|EG008|Reported Event|Nurse Focus Group - VidaTalk RCT|Focus group of ICU nurses regarding the utility of the VidaTalk Intervention for communication with patients.
11092250|NCT01538472|FG000|Participant Flow|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (BCNU) (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
11286161|NCT02884492|FG000|Participant Flow|Cognitive Impairment|"Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
10820858|NCT00063232|FG000|Participant Flow|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
10807937|NCT02870348|BG000|Baseline|Alpha-1 MP|Participants received IV infusion of 60 mg/kg Alpha-1 MP administered weekly for mean duration of 213 weeks.
10807938|NCT02870348|FG000|Participant Flow|Alpha-1 MP|Participants received IV infusion of 60 mg/kg Alpha-1 MP administered weekly for mean duration of 213 weeks.
10807939|NCT02870348|OG000|Outcome|Alpha-1 MP|Participants received IV infusion of 60 mg/kg Alpha-1 MP administered weekly for mean duration of 213 weeks.
10807940|NCT02870348|EG000|Reported Event|Alpha-1 MP|Participants received IV infusion of 60 mg/kg Alpha-1 MP administered weekly for mean duration of 213 weeks.
10807941|NCT02841280|BG000|Baseline|Chlorthalidone|"Subjects with stage 4 chronic kidney disease (CKD) and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home blood pressure (BP) results.~Chlorthalidone: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807942|NCT02841280|BG001|Baseline|Placebo|"Subjects with stage 4 CKD and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home BP results.~Placebo: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807943|NCT02841280|BG002|Baseline|Total|Total of all reporting groups
10807944|NCT02841280|FG000|Participant Flow|Chlorthalidone|"Subjects with stage 4 chronic kidney disease (CKD) and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home blood pressure (BP) results.~Chlorthalidone: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807945|NCT02841280|FG001|Participant Flow|Placebo|"Subjects with stage 4 CKD and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home BP results.~Placebo: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807946|NCT02841280|OG000|Outcome|Chlorthalidone|"Subjects with stage 4 chronic kidney disease (CKD) and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home blood pressure (BP) results.~Chlorthalidone: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807947|NCT02841280|OG001|Outcome|Placebo|"Subjects with stage 4 CKD and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home BP results.~Placebo: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807948|NCT02841280|EG000|Reported Event|Chlorthalidone|"Subjects with stage 4 chronic kidney disease (CKD) and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home blood pressure (BP) results.~Chlorthalidone: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807949|NCT02841280|EG001|Reported Event|Placebo|"Subjects with stage 4 CKD and poorly controlled hypertension confirmed by 24 hour ambulatory blood pressure monitoring will be randomized into two groups, one receiving placebo and one receiving a diuretic called chlorthalidone (12.5 mg at randomization). Doubling of the dose of the diuretic (up to 50 mg) or placebo will occur every 4 weeks if required by home BP results.~Placebo: This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)"
10807950|NCT02786498|BG000|Baseline|High Loading Dose|"150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Vitamin D3~Placebo"
10807951|NCT02786498|BG001|Baseline|High Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807952|NCT02786498|BG002|Baseline|Low Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807953|NCT02786498|BG003|Baseline|Control Group|"Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Placebo"
10807954|NCT02786498|BG004|Baseline|Total|Total of all reporting groups
10807955|NCT02786498|FG000|Participant Flow|High Loading Dose|"150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Vitamin D3~Placebo"
10807956|NCT02786498|FG001|Participant Flow|High Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807957|NCT02786498|FG002|Participant Flow|Low Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807958|NCT02786498|FG003|Participant Flow|Control Group|"Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Placebo"
10807959|NCT02786498|OG000|Outcome|High Loading Dose|"150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Vitamin D3~Placebo"
10807960|NCT02786498|OG001|Outcome|High Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807961|NCT02786498|OG002|Outcome|Low Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807962|NCT02786498|OG003|Outcome|Control Group|"Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Placebo"
10807963|NCT02786498|EG000|Reported Event|High Loading Dose|"150,000 IU loading dose vitamin D3 at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Vitamin D3~Placebo"
10807964|NCT02786498|EG001|Reported Event|High Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 4,000 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807965|NCT02786498|EG002|Reported Event|Low Daily Dose|"Loading dose placebo at enrolment and 6 weeks, plus 600 IU vitamin D3 per day for 3 months.~Vitamin D3~Placebo"
10807966|NCT02786498|EG003|Reported Event|Control Group|"Loading dose placebo at enrolment and 6 weeks, plus daily dose placebo for 3 months.~Placebo"
10807967|NCT02771275|BG000|Baseline|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10807968|NCT02771275|FG000|Participant Flow|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10807969|NCT02771275|OG000|Outcome|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10807970|NCT02771275|EG000|Reported Event|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in subjects with degenerative mitral regurgitation.
10807971|NCT02675426|BG000|Baseline|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
10807972|NCT02675426|BG001|Baseline|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
10807973|NCT02675426|BG002|Baseline|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
10807974|NCT02675426|BG003|Baseline|Total|Total of all reporting groups
10807975|NCT02675426|FG000|Participant Flow|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
10807976|NCT02675426|FG001|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
10807977|NCT02675426|FG002|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
10807978|NCT02675426|OG000|Outcome|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
10807979|NCT02675426|OG001|Outcome|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
10807980|NCT02675426|OG002|Outcome|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
10807981|NCT02675426|EG000|Reported Event|Placebo|Participants received placebo once daily for 12 weeks in Period 1.
10807982|NCT02675426|EG001|Reported Event|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1.
10807983|NCT02675426|EG002|Reported Event|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
10807984|NCT02639546|BG000|Baseline|Phase I (Tablet) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807985|NCT02639546|BG001|Baseline|Phase I (Tablet) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
11286162|NCT02884492|FG001|Participant Flow|No Cognitive Impairment|"Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
10807986|NCT02639546|BG002|Baseline|Phase I (Tablet) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807987|NCT02639546|BG003|Baseline|Phase I (Suspension) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807988|NCT02639546|BG004|Baseline|Phase I (Suspension) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807989|NCT02639546|BG005|Baseline|Phase I (Suspension) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807990|NCT02639546|BG006|Baseline|Phase I (Suspension) Cobimetinib (1.33 mg/kg)|Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807991|NCT02639546|BG007|Baseline|Phase II (Suspension) Cobimetinib (1 mg/kg)|Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807992|NCT02639546|BG008|Baseline|Total|Total of all reporting groups
10807993|NCT02639546|FG000|Participant Flow|Phase I (Tablet) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807994|NCT02639546|FG001|Participant Flow|Phase I (Tablet) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807995|NCT02639546|FG002|Participant Flow|Phase I (Tablet) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807996|NCT02639546|FG003|Participant Flow|Phase I (Suspension) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807997|NCT02639546|FG004|Participant Flow|Phase I (Suspension) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807998|NCT02639546|FG005|Participant Flow|Phase I (Suspension) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10807999|NCT02639546|FG006|Participant Flow|Phase I (Suspension) Cobimetinib (1.33 mg/kg)|Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808000|NCT02639546|FG007|Participant Flow|Phase II (Suspension) Cobimetinib (1 mg/kg)|Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808001|NCT02639546|OG000|Outcome|Phase I (Tablet) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808002|NCT02639546|OG001|Outcome|Phase I (Tablet) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808003|NCT02639546|OG002|Outcome|Phase I (Tablet) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808004|NCT02639546|OG003|Outcome|Phase I (Suspension) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808005|NCT02639546|OG004|Outcome|Phase I (Suspension) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808006|NCT02639546|OG005|Outcome|Phase I (Suspension) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808007|NCT02639546|OG006|Outcome|Phase I (Suspension) Cobimetinib (1.33 mg/kg)|Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808008|NCT02639546|OG007|Outcome|Phase II (Suspension) Cobimetinib (1 mg/kg)|Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808009|NCT02639546|OG000|Outcome|Cobimetinib (Tablet) Population|Participants received Cobimetinib (Tablet) formulation
10808010|NCT02639546|OG001|Outcome|Cobimetinib (Suspension) Population|Participants received Cobimetinib (Suspension) formulation
10808011|NCT02639546|OG000|Outcome|Neuroblastoma|Participants with Neuroblastoma.
10808012|NCT02639546|OG000|Outcome|High Grade Glioma|Participants with High Grade Glioma.
10808013|NCT02639546|OG001|Outcome|Low Grade Glioma|Participants with Low Grade Glioma.
10808014|NCT02639546|OG000|Outcome|Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation|Participants with Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation.
10808015|NCT02639546|OG001|Outcome|Malignant Peripheral Nerve Sheath Tumor|Participants with Malignant Peripheral Nerve Sheath Tumor.
10808016|NCT02639546|OG002|Outcome|Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation|Participants with Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation.
10808017|NCT02639546|OG003|Outcome|Non-Rhabdomyosarcoma Soft Tissue Sarcoma|Participants with Non-Rhabdomyosarcoma Soft Tissue Sarcoma.
10808018|NCT02639546|OG004|Outcome|Plexiform Neurofibroma|Participants with Plexiform Neurofibroma.
10808019|NCT02639546|OG005|Outcome|Rhabdoid Tumor/ATRT|Participants with Rhabdoid Tumor/ATRT.
10808020|NCT02639546|OG000|Outcome|Low Grade Glioma|Participants with Low Grade Glioma.
10808021|NCT02639546|OG000|Outcome|Cobimetinib (Suspension) Population|Participants received Cobimetinib (Suspension) formulation
11205317|NCT02227784|EG000|Reported Event|Atorvastatin + Evacetrapib Double-Blind (DB)|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10808022|NCT02639546|OG000|Outcome|Low Grade Glioma|Participants with Low Grade Glioma
10808023|NCT02639546|EG000|Reported Event|Phase I (Tablet) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808024|NCT02639546|EG001|Reported Event|Phase I (Tablet) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808025|NCT02639546|EG002|Reported Event|Phase I (Tablet) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808026|NCT02639546|EG003|Reported Event|Phase I (Suspension) Cobimetinib (0.6 mg/kg)|Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808027|NCT02639546|EG004|Reported Event|Phase I (Suspension) Cobimetinib (0.8 mg/kg)|Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808028|NCT02639546|EG005|Reported Event|Phase I (Suspension) Cobimetinib (1 mg/kg)|Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808029|NCT02639546|EG006|Reported Event|Phase I (Suspension) Cobimetinib (1.33 mg/kg)|Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808030|NCT02639546|EG007|Reported Event|Phase II (Suspension) Cobimetinib (1 mg/kg)|Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
10808031|NCT02575339|BG000|Baseline|Phase I, Level 1: 15 mg of MLN0128|Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level
10808032|NCT02575339|BG001|Baseline|Phase I, Level 2: 20mg of MLN0128|Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level
10808033|NCT02575339|BG002|Baseline|Phase I, Level 3: 30mg of MLN0128|Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
10808034|NCT02575339|BG003|Baseline|Total|Total of all reporting groups
10808035|NCT02575339|FG000|Participant Flow|Phase I, Level 1: 15 mg of MLN0128|Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level
10808036|NCT02575339|FG001|Participant Flow|Phase I, Level 2: 20mg of MLN0128|Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level
10808037|NCT02575339|FG002|Participant Flow|Phase I, Level 3: 30mg of MLN0128|Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
10808038|NCT02575339|OG000|Outcome|Phase I, Level 1: 15 mg of MLN0128|Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level
11205318|NCT02227784|EG001|Reported Event|Atorvastatin 40 mg DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11205319|NCT02227784|EG002|Reported Event|Atorvastatin 80 mg DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10808039|NCT02575339|OG001|Outcome|Phase I, Level 2: 20mg of MLN0128|Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level
10808040|NCT02575339|OG002|Outcome|Phase I, Level 3: 30mg of MLN0128|Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
10808041|NCT02575339|OG000|Outcome|Phase II Arm A: MLN0128|"Subjects randomized to experimental arm will receive MLN0128 orally at the recommended phase II dose (RP2D) once weekly.~MLN0128 (RP2D): Phase II Arm A:~MLN0128 administered orally at the recommended phase II dose (RP2D) once weekly."
10808042|NCT02575339|OG001|Outcome|Phase II Arm B: Sorafenib|"Subjects randomized to control arm will receive sorafenib 400mg by mouth (PO) twice a day (BID) daily.~Sorafenib: Phase II Arm B:~Sorafenib administered at 400mg PO BID daily"
10808043|NCT02575339|EG000|Reported Event|Phase I, Level 1: 15 mg of MLN0128|Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level
10808044|NCT02575339|EG001|Reported Event|Phase I, Level 2: 20mg of MLN0128|Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level
10808045|NCT02575339|EG002|Reported Event|Phase I, Level 3: 30mg of MLN0128|Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
10808046|NCT02498444|BG000|Baseline|Treprostinil|Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
10808047|NCT02498444|BG001|Baseline|Saline|Saline administration via subcutaneous infusion.
10808048|NCT02498444|BG002|Baseline|Total|Total of all reporting groups
10808049|NCT02498444|FG000|Participant Flow|Treprostinil|Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
10808050|NCT02498444|FG001|Participant Flow|Saline|Saline administration via subcutaneous infusion.
10808051|NCT02498444|OG000|Outcome|Treprostinil|Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
10808052|NCT02498444|OG001|Outcome|Saline|Saline administration via subcutaneous infusion.
10808053|NCT02498444|EG000|Reported Event|Treprostinil|Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
10808054|NCT02498444|EG001|Reported Event|Saline|Saline administration via subcutaneous infusion.
10808055|NCT02487108|BG000|Baseline|Placebo|Participants received placebo matched to TV46763 (hydrocodone bitartrate/acetaminophen) IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808056|NCT02487108|BG001|Baseline|TV-46763 5.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808057|NCT02487108|BG002|Baseline|TV-46763 7.5 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808058|NCT02487108|BG003|Baseline|TV-46763 10.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808059|NCT02487108|BG004|Baseline|Total|Total of all reporting groups
10808060|NCT02487108|FG000|Participant Flow|Placebo|Participants received placebo matched to TV46763 (hydrocodone bitartrate/acetaminophen) immediate release (IR) tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808061|NCT02487108|FG001|Participant Flow|TV-46763 5.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 milligrams (mg)/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808062|NCT02487108|FG002|Participant Flow|TV-46763 7.5 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808063|NCT02487108|FG003|Participant Flow|TV-46763 10.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808064|NCT02487108|OG000|Outcome|Placebo|Participants received placebo matched to TV46763 (hydrocodone bitartrate/acetaminophen) IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808065|NCT02487108|OG001|Outcome|TV-46763 5.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808066|NCT02487108|OG002|Outcome|TV-46763 7.5 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808067|NCT02487108|OG003|Outcome|TV-46763 10.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808068|NCT02487108|EG000|Reported Event|Placebo|Participants received placebo matched to TV46763 (hydrocodone bitartrate/acetaminophen) IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808069|NCT02487108|EG001|Reported Event|TV-46763 5.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808070|NCT02487108|EG002|Reported Event|TV-46763 7.5 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808071|NCT02487108|EG003|Reported Event|TV-46763 10.0 mg/325 mg|Participants received TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants continued to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
10808072|NCT02455557|BG000|Baseline|Treatment (SurVaxM, Temozolomide)|"Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Montanide ISA 51 VG: Given SC~Sargramostim: Given SC~SVN53-67/M57-KLH Peptide Vaccine: Given SC~Temozolomide: Given PO or IV"
10808073|NCT02455557|FG000|Participant Flow|Treatment (SurVaxM, Temozolomide)|"Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Montanide ISA 51 VG: Given SC~Sargramostim: Given SC~SVN53-67/M57-KLH Peptide Vaccine: Given SC~Temozolomide: Given PO or IV"
10808074|NCT02455557|OG000|Outcome|Treatment (SurVaxM, Temozolomide)|"Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Montanide ISA 51 VG: Given SC~Sargramostim: Given SC~SVN53-67/M57-KLH Peptide Vaccine: Given SC~Temozolomide: Given PO or IV"
10808075|NCT02455557|EG000|Reported Event|Treatment (SurVaxM, Temozolomide)|"Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Montanide ISA 51 VG: Given SC~Sargramostim: Given SC~SVN53-67/M57-KLH Peptide Vaccine: Given SC~Temozolomide: Given PO or IV"
10808080|NCT02393690|BG000|Baseline|Arm I (Selumetinib, Iodine I-131)|Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
10808081|NCT02393690|BG001|Baseline|Arm II (Placebo, Iodine I-131)|Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
10808082|NCT02393690|BG002|Baseline|Total|Total of all reporting groups
10808083|NCT02393690|FG000|Participant Flow|Arm I (Selumetinib, Iodine I-131)|Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
10808084|NCT02393690|FG001|Participant Flow|Arm II (Placebo, Iodine I-131)|Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
10808085|NCT02393690|OG000|Outcome|Arm I (Selumetinib, Iodine I-131)|Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
10808086|NCT02393690|OG001|Outcome|Arm II (Placebo, Iodine I-131)|Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
10808087|NCT02393690|EG000|Reported Event|Arm I (Selumetinib, Iodine I-131)|Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
10808088|NCT02393690|EG001|Reported Event|Arm II (Placebo, Iodine I-131)|Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
10808089|NCT02387996|BG000|Baseline|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
10808090|NCT02387996|FG000|Participant Flow|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
10808091|NCT02387996|OG000|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
10808092|NCT02387996|EG000|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
10808093|NCT02363010|BG000|Baseline|Standard Behavior Therapy for Weight Loss|"Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808094|NCT02363010|BG001|Baseline|Behavior Therapy for Weight Loss With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
11205320|NCT02227784|EG003|Reported Event|Atorvastatin + Ezetimibe DB|Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
10808095|NCT02363010|BG002|Baseline|Acceptance-based Behavior Therapy With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808096|NCT02363010|BG003|Baseline|Total|Total of all reporting groups
10808097|NCT02363010|FG000|Participant Flow|Standard Behavior Therapy for Weight Loss|"Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808098|NCT02363010|FG001|Participant Flow|Behavior Therapy for Weight Loss With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10820859|NCT00063232|OG000|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
11286163|NCT02884492|OG000|Outcome|Cognitive Impairment|"Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
11092251|NCT01538472|OG000|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
11205321|NCT02227784|EG004|Reported Event|Atorvastatin + Evacetrapib Open-Label (OLE)|Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
11244282|NCT02509767|FG000|Participant Flow|Self-Administration|"Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
11244283|NCT02509767|FG001|Participant Flow|Clinic Administration (Standard Care)|"Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
11244284|NCT02509767|OG000|Outcome|Self-Administration|"Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
11244285|NCT02509767|OG001|Outcome|Clinic Administration (Standard Care)|"Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
11244286|NCT02509767|OG000|Outcome|Clinic Administration (Standard Care)|Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.
11244287|NCT02509767|OG001|Outcome|Self-Administration|Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.
11244288|NCT02509767|OG000|Outcome|Self-Administration|Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.
11244289|NCT02509767|EG000|Reported Event|Self-Administration|"Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
11244290|NCT02509767|EG001|Reported Event|Clinic Administration (Standard Care)|"Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.~Subcutaneous depot medroxyprogesterone acetate: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel."
10808099|NCT02363010|FG002|Participant Flow|Acceptance-based Behavior Therapy With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808100|NCT02363010|OG000|Outcome|Standard Behavior Therapy for Weight Loss|"Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808101|NCT02363010|OG001|Outcome|Behavior Therapy for Weight Loss With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808102|NCT02363010|OG002|Outcome|Acceptance-based Behavior Therapy With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808103|NCT02363010|EG000|Reported Event|Standard Behavior Therapy for Weight Loss|"Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808104|NCT02363010|EG001|Reported Event|Behavior Therapy for Weight Loss With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808105|NCT02363010|EG002|Reported Event|Acceptance-based Behavior Therapy With PA Emphasis|"Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.~Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).~Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session)."
10808106|NCT02351856|BG000|Baseline|ARRY-371797|Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug.
11244291|NCT02509936|BG000|Baseline|Standard of Care Arm|"In this arm enrolled children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10808107|NCT02351856|FG000|Participant Flow|ARRY-371797|Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA (Gene encoding the Lamin A/C protein) mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 milligram (mg) twice a day (BID) until treatment discontinuation criteria [withdrawal of consent, unacceptable adverse events (AE) or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug.
10808108|NCT02351856|OG000|Outcome|ARRY-371797|Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug.
10808109|NCT02351856|EG000|Reported Event|ARRY-371797|Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug.
10808110|NCT02349386|BG000|Baseline|BHR-200 Low Dose|"3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808111|NCT02349386|BG001|Baseline|BHR-200 Mid Dose|"6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808112|NCT02349386|BG002|Baseline|BHR-200 High Dose|"9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808113|NCT02349386|BG003|Baseline|Placebo|"1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.~Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol."
10808114|NCT02349386|BG004|Baseline|Total|Total of all reporting groups
10808115|NCT02349386|FG000|Participant Flow|BHR-200 Low Dose|"3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808116|NCT02349386|FG001|Participant Flow|BHR-200 Mid Dose|"6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808117|NCT02349386|FG002|Participant Flow|BHR-200 High Dose|"9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808118|NCT02349386|FG003|Participant Flow|Placebo|"1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.~Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol."
10808119|NCT02349386|OG000|Outcome|BHR-200 Low Dose|"3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808120|NCT02349386|OG001|Outcome|BHR-200 Mid Dose|"6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808121|NCT02349386|OG002|Outcome|BHR-200 High Dose|"9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808122|NCT02349386|OG003|Outcome|Placebo|"1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.~Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol."
10808123|NCT02349386|EG000|Reported Event|BHR-200 Low Dose|"3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808124|NCT02349386|EG001|Reported Event|BHR-200 Mid Dose|"6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
10808125|NCT02349386|EG002|Reported Event|BHR-200 High Dose|"9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.~BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol."
11286164|NCT02884492|OG001|Outcome|No Cognitive Impairment|"Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
11205322|NCT02227810|BG000|Baseline|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
11205323|NCT02227810|BG001|Baseline|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
10808126|NCT02349386|EG003|Reported Event|Placebo|"1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.~Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol."
11205324|NCT02227810|BG002|Baseline|Total|Total of all reporting groups
11205325|NCT02227810|FG000|Participant Flow|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
10808127|NCT02328014|BG000|Baseline|Part 1 Cohort 1|Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
10808128|NCT02328014|BG001|Baseline|Part 1 Cohort 2|Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808129|NCT02328014|BG002|Baseline|Part 1 Cohort 3|Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
10808130|NCT02328014|BG003|Baseline|Part 2|Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808131|NCT02328014|BG004|Baseline|Total|Total of all reporting groups
10808132|NCT02328014|FG000|Participant Flow|Part 1 Cohort 1|Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
10808133|NCT02328014|FG001|Participant Flow|Part 1 Cohort 2|Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808134|NCT02328014|FG002|Participant Flow|Part 1 Cohort 3|Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
10808135|NCT02328014|FG003|Participant Flow|Part 2|Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808136|NCT02328014|OG000|Outcome|Part 1 Cohort 1|Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
10808137|NCT02328014|OG001|Outcome|Part 1 Cohort 2|Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808138|NCT02328014|OG002|Outcome|Part 1 Cohort 3|Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
10808139|NCT02328014|OG003|Outcome|Part 2|Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808140|NCT02328014|EG000|Reported Event|Part 1 Cohort 1|Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
10808141|NCT02328014|EG001|Reported Event|Part 1 Cohort 2|Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808142|NCT02328014|EG002|Reported Event|Part 1 Cohort 3|Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
10808143|NCT02328014|EG003|Reported Event|Part 2|Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
10808144|NCT02281500|BG000|Baseline|FIB Grifols 70 mg/kg Body Weight|Participants received a single dose of slow intravenous infusion of Human Plasma-Derived Fibrinogen Concentrate Grifols (FIB Grifols) 70 mg/kg body weight, at a rate not exceeding 5 mL/minute, on Day 0.
10808145|NCT02281500|FG000|Participant Flow|FIB Grifols 70 mg/kg Body Weight|Participants received a single dose of slow intravenous infusion of Human Plasma-Derived Fibrinogen Concentrate Grifols (FIB Grifols) 70 milligram per kilogram (mg/kg) body weight, at a rate not exceeding 5 milliliter per minute (mL/min), on Day 0.
10808146|NCT02281500|OG000|Outcome|FIB Grifols 70 mg/kg Body Weight|Participants received a single dose of slow intravenous infusion of Human Plasma-Derived Fibrinogen Concentrate Grifols (FIB Grifols) 70 mg/kg body weight, at a rate not exceeding 5 mL/minute, on Day 0.
10808147|NCT02281500|EG000|Reported Event|FIB Grifols 70 mg/kg Body Weight|Participants received a single dose of slow IV infusion of FIB Grifols 70 mg/kg body weight, at a rate not exceeding 5 mL/minute, on Day 0.
10808148|NCT02243020|BG000|Baseline|Vagus Nerve Stimulation (VNS) + Rehabilitation (1)|"This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.~Vagus Nerve Stimulation (VNS)"
10808149|NCT02243020|BG001|Baseline|Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator|"This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.~Vagus Nerve Stimulation (VNS)"
10808150|NCT02243020|BG002|Baseline|Total|Total of all reporting groups
10808151|NCT02243020|FG000|Participant Flow|Vagus Nerve Stimulation (VNS) + Rehabilitation (1)|"This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.~Vagus Nerve Stimulation (VNS)"
10808152|NCT02243020|FG001|Participant Flow|Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator|"This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.~Vagus Nerve Stimulation (VNS)"
10808153|NCT02243020|OG000|Outcome|Vagus Nerve Stimulation (VNS) + Rehabilitation (1)|"This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.~Vagus Nerve Stimulation (VNS)"
10808154|NCT02243020|OG001|Outcome|Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator|"This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.~Vagus Nerve Stimulation (VNS)"
10808155|NCT02243020|EG000|Reported Event|Vagus Nerve Stimulation (VNS) + Rehabilitation (1)|"This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.~Vagus Nerve Stimulation (VNS)"
10808156|NCT02243020|EG001|Reported Event|Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator|"This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.~Vagus Nerve Stimulation (VNS)"
11205326|NCT02227810|FG001|Participant Flow|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
11205327|NCT02227810|OG000|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
11205328|NCT02227810|OG001|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
11205329|NCT02227810|OG000|Outcome|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
11205330|NCT02227810|OG001|Outcome|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
10808161|NCT01905384|BG000|Baseline|U-SEMS Group|"Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).~Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions."
10808162|NCT01905384|BG001|Baseline|C-SEMS Group|"Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)~Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction."
10808163|NCT01905384|BG002|Baseline|Total|Total of all reporting groups
10808164|NCT01905384|FG000|Participant Flow|U-SEMS Group|"Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).~Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions."
10808165|NCT01905384|FG001|Participant Flow|C-SEMS Group|"Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)~Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction."
10808166|NCT01905384|OG000|Outcome|U-SEMS Group|"Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).~Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions."
10808167|NCT01905384|OG001|Outcome|C-SEMS Group|"Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)~Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction."
10808168|NCT01905384|EG000|Reported Event|U-SEMS Group|"Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).~Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions."
10808169|NCT01905384|EG001|Reported Event|C-SEMS Group|"Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)~Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction."
10808170|NCT01904032|BG000|Baseline|Low Dose|5,000 international units (IUs) of a weekly Vitamin D3 comparator
10808171|NCT01904032|BG001|Baseline|High Dose|50,000 international units (IUs) weekly Vitamin D3
10808172|NCT01904032|BG002|Baseline|Total|Total of all reporting groups
10808173|NCT01904032|FG000|Participant Flow|Low Dose|5,000 international units (IUs) of a weekly Vitamin D3 comparator
10808174|NCT01904032|FG001|Participant Flow|High Dose|50,000 international units (IUs) weekly Vitamin D3
10808175|NCT01904032|OG000|Outcome|Low Dose|5,000 international units (IUs) of a weekly Vitamin D3 comparator
10808176|NCT01904032|OG001|Outcome|High Dose|50,000 international units (IUs) weekly Vitamin D3
10808177|NCT01904032|EG000|Reported Event|Low Dose|5,000 international units (IUs) of a weekly Vitamin D3 comparator
10808178|NCT01904032|EG001|Reported Event|High Dose|50,000 international units (IUs) weekly Vitamin D3
10808179|NCT01876953|BG000|Baseline|Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
11205331|NCT02227810|EG000|Reported Event|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
10808180|NCT01876953|BG001|Baseline|Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10808181|NCT01876953|BG002|Baseline|Total|Total of all reporting groups
10808182|NCT01876953|FG000|Participant Flow|Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10808183|NCT01876953|FG001|Participant Flow|Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10808184|NCT01876953|OG000|Outcome|Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
11205332|NCT02227810|EG001|Reported Event|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
10808185|NCT01876953|OG001|Outcome|Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10808186|NCT01876953|EG000|Reported Event|Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
10808187|NCT01876953|EG001|Reported Event|Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day|"Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.~cytarabine: Given IV~idarubicin: Given IV~dasatinib: Given PO~laboratory biomarker analysis: Correlative studies"
11244292|NCT02509936|BG001|Baseline|Home-based Education|"In the intervention arm, children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they received monthly home visits from a community health promoter who provided detailed dietary assessments and individualized dietary coaching and education to parents.~Home-based nutrition education: Health promoters used 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10808197|NCT01764711|BG000|Baseline|Low Salt Diet POTS|After 7 days of being on a low salt diets, POTS patients and controls will be asked to undergo Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
10808198|NCT01764711|BG001|Baseline|Low Salt Diet Controls|After 7 days of being on a low salt diets, POTS patients and controls will be asked to undergo Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
10808199|NCT01764711|BG002|Baseline|Total|Total of all reporting groups
10808200|NCT01764711|FG000|Participant Flow|Low Salt Diet POTS|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
10808201|NCT01764711|FG001|Participant Flow|Low Salt Diet Controls|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
10808202|NCT01764711|OG000|Outcome|Low Salt Diet POTS|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
10808203|NCT01764711|OG001|Outcome|Low Salt Diet Controls|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
10808204|NCT01764711|EG000|Reported Event|Low Salt Diet POTS|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
11205333|NCT02227836|BG000|Baseline|Allergy Patch Testing APT|"Patient will undergo APT testing per the following protocol:~2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.~Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits~The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.~Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles)."
11244293|NCT02509936|BG002|Baseline|Total|Total of all reporting groups
11244294|NCT02509936|FG000|Participant Flow|Standard of Care Arm|"In this arm enrolled children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10808205|NCT01764711|EG001|Reported Event|Low Salt Diet Controls|"Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.~Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration."
10820860|NCT00063232|EG000|Reported Event|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
10820861|NCT00063258|BG000|Baseline|Chemotherapy + Tarceva|
10820862|NCT00063258|BG001|Baseline|Chemotherapy Alone|
10820863|NCT00063258|BG002|Baseline|Total|Total of all reporting groups
10820864|NCT00063258|FG000|Participant Flow|Chemotherapy + Tarceva|
10820865|NCT00063258|FG001|Participant Flow|Chemotherapy Alone|
10820866|NCT00063258|OG000|Outcome|Chemotherapy + Tarceva|
10820867|NCT00063258|OG001|Outcome|Chemotherapy Alone|
10820868|NCT00063258|EG000|Reported Event|Chemotherapy + Tarceva|
10820869|NCT00063258|EG001|Reported Event|Chemotherapy Alone|
10820870|NCT00063362|BG000|Baseline|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820871|NCT00063362|BG001|Baseline|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820872|NCT00063362|BG002|Baseline|Total|Total of all reporting groups
10820873|NCT00063362|FG000|Participant Flow|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent/L (mEq/L)."
10820874|NCT00063362|FG001|Participant Flow|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820875|NCT00063362|OG000|Outcome|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820876|NCT00063362|OG001|Outcome|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820877|NCT00063362|EG000|Reported Event|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10820878|NCT00063362|EG001|Reported Event|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
10808206|NCT01632878|BG000|Baseline|Post Myocardial Infarction Omacor Group|Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
10808207|NCT01632878|BG001|Baseline|Post Myocardial Infarction Non-Omacor Group|Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
10808208|NCT01632878|BG002|Baseline|Total|Total of all reporting groups
10808209|NCT01632878|FG000|Participant Flow|Post Myocardial Infarction|One single cohort of Index post Myocardial Infarction patients
10808210|NCT01632878|OG000|Outcome|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
10808211|NCT01632878|EG000|Reported Event|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
10808212|NCT01275846|BG000|Baseline|Health Guide Using AHA Protocols|Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
10808213|NCT01275846|FG000|Participant Flow|Health Guide Using AHA Protocols|Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
10808214|NCT01275846|OG000|Outcome|Health Guide Using AHA Protocols|Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
10808215|NCT01275846|EG000|Reported Event|Health Guide Using AHA Protocols|Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
10808216|NCT01097005|BG000|Baseline|Clarithromycin|Those with an exposure
10808217|NCT01097005|FG000|Participant Flow|Clarithromycin|Those with an exposure
10808218|NCT01097005|OG000|Outcome|Clarithromycin|Negative conversion / Yes
10808219|NCT01097005|OG000|Outcome|Clarithromycin|Those with an exposure
10808220|NCT01097005|OG000|Outcome|Clarithromycin|The subjects who completed the study
10808221|NCT01097005|EG000|Reported Event|Clarithromycin|Those with an exposure
10808222|NCT01072682|BG000|Baseline|SCD Experimental Treatment Arm|"Selective Cytopheretic Device~Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
10808223|NCT01072682|FG000|Participant Flow|SCD Experimental Treatment Arm|"Selective Cytopheretic Device~Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
10808224|NCT01072682|OG000|Outcome|SCD Experimental Treatment Arm|"Selective Cytopheretic Device~Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
10808225|NCT01072682|EG000|Reported Event|SCD Experimental Treatment Arm|"Selective Cytopheretic Device~Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
10808226|NCT00931255|BG000|Baseline|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
10808227|NCT00931255|BG001|Baseline|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
10808228|NCT00931255|BG002|Baseline|Total|Total of all reporting groups
10808229|NCT00931255|FG000|Participant Flow|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
10808230|NCT00931255|FG001|Participant Flow|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
10808231|NCT00931255|OG000|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
10808232|NCT00931255|OG001|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
10808233|NCT00931255|EG000|Reported Event|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
10808234|NCT00931255|EG001|Reported Event|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
10808235|NCT00540995|BG000|Baseline|Arm I: 1200cGy|"1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.~GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808236|NCT00540995|BG001|Baseline|Arm II: 1350cGy|"1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808237|NCT00540995|BG002|Baseline|Total|Total of all reporting groups
10808238|NCT00540995|FG000|Participant Flow|Arm I: 1200cGy|"1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.~GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808239|NCT00540995|FG001|Participant Flow|Arm II: 1350cGy|"1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808240|NCT00540995|OG000|Outcome|Arm I: 1200cGy|"1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.~GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10820879|NCT00063570|BG000|Baseline|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
10820880|NCT00063570|BG001|Baseline|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
10808241|NCT00540995|EG000|Reported Event|Arm I: 1200cGy|"1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.~GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808242|NCT00540995|EG001|Reported Event|Arm II: 1350cGy|"1350cGy = 150cGy x 9 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.~busulfan: Given IV~etoposide: Given IV~intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses~allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy~tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses"
10808243|NCT00418301|BG000|Baseline|Precision Spinal Cord Stimulation and PET Scan|"Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.~Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation."
10808244|NCT00418301|FG000|Participant Flow|Precision Spinal Cord Stimulation and PET Scan|"Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.~Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation."
10808245|NCT00418301|OG000|Outcome|Precision Spinal Cord Stimulation and PET Scan|"Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.~Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation."
10808246|NCT00418301|EG000|Reported Event|Precision Spinal Cord Stimulation and PET Scan|"Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.~Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation."
10820881|NCT00063570|BG002|Baseline|Total|Total of all reporting groups
10820882|NCT00063570|FG000|Participant Flow|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
10820883|NCT00063570|FG001|Participant Flow|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
10820884|NCT00063570|OG000|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
10820885|NCT00063570|OG001|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
10820886|NCT00063570|EG000|Reported Event|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
10820887|NCT00063570|EG001|Reported Event|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
10820888|NCT00063622|BG000|Baseline|Pioglitazone|Pioglitazone at a dose of 30 mg daily
10820889|NCT00063622|BG001|Baseline|Vitamin E|Vitamin E at a dose of 800 IU daily
10820890|NCT00063622|BG002|Baseline|Placebo|Placebo Pioglitazone and Placebo Vitamin E
10820891|NCT00063622|BG003|Baseline|Total|Total of all reporting groups
10820892|NCT00063622|FG000|Participant Flow|Pioglitazone|Pioglitazone at a dose of 30 mg daily
10820893|NCT00063622|FG001|Participant Flow|Vitamin E|Vitamin E at a dose of 800 IU daily
10820894|NCT00063622|FG002|Participant Flow|Placebo|Placebo Pioglitazone and Placebo Vitamin E
10820895|NCT00063622|OG000|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
10820896|NCT00063622|OG001|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
10820897|NCT00063622|OG002|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
10820898|NCT00063622|EG000|Reported Event|Pioglitazone|Pioglitazone at a dose of 30 mg daily
10820899|NCT00063622|EG001|Reported Event|Vitamin E|Vitamin E at a dose of 800 IU daily
10820900|NCT00063622|EG002|Reported Event|Placebo|Placebo Pioglitazone and Placebo Vitamin E
10820901|NCT00063635|BG000|Baseline|Metformin|Metformin, 500 mg, twice daily
10820902|NCT00063635|BG001|Baseline|Vitamin E|Vitamin E, 400 IU, twice daily
10820903|NCT00063635|BG002|Baseline|Placebo|Matching placebo
10820904|NCT00063635|BG003|Baseline|Total|Total of all reporting groups
10820905|NCT00063635|FG000|Participant Flow|Metformin|Metformin, 500 mg, twice daily
10820906|NCT00063635|FG001|Participant Flow|Vitamin E|Vitamin E, 400 IU, twice daily
10820907|NCT00063635|FG002|Participant Flow|Placebo|Matching placebo
10820908|NCT00063635|OG000|Outcome|Metformin|Metformin, 500 mg, twice daily
10820909|NCT00063635|OG001|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
10820910|NCT00063635|OG002|Outcome|Placebo|Matching placebo
10820911|NCT00063635|EG000|Reported Event|Metformin|Metformin, 500 mg, twice daily
10820912|NCT00063635|EG001|Reported Event|Vitamin E|Vitamin E, 400 IU, twice daily
10820913|NCT00063635|EG002|Reported Event|Placebo|Matching placebo
10820914|NCT00063882|BG000|Baseline|EBRT + Brachytherapy|External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
10808247|NCT04498273|BG000|Baseline|Apixaban 2.5mg|Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
10808248|NCT04498273|BG001|Baseline|Apixaban 5mg|Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
10808249|NCT04498273|BG002|Baseline|Asprin|Antiplatelet agent: low dose aspirin 81mg po qd
10808250|NCT04498273|BG003|Baseline|Placebo|Only Placebo
10808251|NCT04498273|BG004|Baseline|Total|Total of all reporting groups
10808252|NCT04498273|FG000|Participant Flow|Apixaban 2.5mg|Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
10808253|NCT04498273|FG001|Participant Flow|Apixaban 5mg|Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
11244295|NCT02509936|FG001|Participant Flow|Home-based Education|"In the intervention arm, children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they received monthly home visits from a community health promoter who provided detailed dietary assessments and individualized dietary coaching and education to parents.~Home-based nutrition education: Health promoters used 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10808254|NCT04498273|FG002|Participant Flow|Asprin|Antiplatelet agent: low dose aspirin 81mg po qd
10808255|NCT04498273|FG003|Participant Flow|Placebo|Only Placebo
10808256|NCT04498273|OG000|Outcome|Apixaban 2.5mg|Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
10808257|NCT04498273|OG001|Outcome|Apixaban 5mg|Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
10808258|NCT04498273|OG002|Outcome|Asprin|Antiplatelet agent: low dose aspirin 81mg po qd
10808259|NCT04498273|OG003|Outcome|Placebo|only Placebo
10808260|NCT04498273|EG000|Reported Event|Apixaban 2.5mg|Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
10808261|NCT04498273|EG001|Reported Event|Apixaban 5mg|Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
10808262|NCT04498273|EG002|Reported Event|Asprin|Antiplatelet agent: low dose aspirin 81mg po qd
10808263|NCT04498273|EG003|Reported Event|Placebo|only Placebo
10808273|NCT04537078|BG000|Baseline|the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Then, Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage.
10808274|NCT04537078|BG001|Baseline|the Flexible GnRh Antagonist|This step will be done twice in two different cycles In each cycle: luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation using antagonist protocol will be used. Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Cetrotide ampule will be given daily as the biggest oocyte reaches size 14 mm. Decapeptyl ampules 0.2 mg will be administered when leading follicle >18 mm in diameter. While in the second cycle HCG triggering (Choriomon)in a dose of 10,000 IU will be administered when the leading follicle >18 mm in diameter. Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle.
10808275|NCT04537078|BG002|Baseline|Total|Total of all reporting groups
10808276|NCT04537078|FG000|Participant Flow|the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration . The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Then, Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. .Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage.
10820915|NCT00063882|BG001|Baseline|Brachytherapy Only|Transperineal interstitial permanent brachytherapy (125/145)
10820916|NCT00063882|BG002|Baseline|Total|Total of all reporting groups
10820917|NCT00063882|FG000|Participant Flow|EBRT + Brachytherapy|External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
10820918|NCT00063882|FG001|Participant Flow|Brachytherapy Only|Transperineal interstitial permanent brachytherapy (125/145)
10820919|NCT00063882|OG000|Outcome|EBRT + Brachytherapy|External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
10820920|NCT00063882|OG001|Outcome|Brachytherapy Only|Transperineal interstitial permanent brachytherapy (125/145)
10820921|NCT00063882|EG000|Reported Event|EBRT + Brachytherapy|45 Gy EBRT to the prostate and seminal vesicles (1.8 Gy daily over 5 weeks) followed within 2-4 weeks by transperineal interstitial permanent brachytherapy as 100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds.
11205334|NCT02227836|FG000|Participant Flow|Allergy Patch Testing APT|"Patient will undergo Atopy Patch Testing (APT) per the following protocol:~2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.~Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits~The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.~Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles)."
11205335|NCT02227836|OG000|Outcome|Allergy Patch Testing APT|"Patient will undergo APT testing per the following protocol:~2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.~Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits~The patches will be removed at 48 hours, and results read at 72 hours after application.~Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles)."
10808264|NCT05224453|BG000|Baseline|Physical Training and High Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d).
10808265|NCT05224453|BG001|Baseline|Physical Training and Low Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (<1 g/kg aBW/d)
10808266|NCT05224453|BG002|Baseline|Total|Total of all reporting groups
10808267|NCT05224453|FG000|Participant Flow|Physical Training and High Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d).
10808268|NCT05224453|FG001|Participant Flow|Physical Training and Low Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (<1 g/kg aBW/d)
10808269|NCT05224453|OG000|Outcome|Physical Training and High Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d).
10808270|NCT05224453|OG001|Outcome|Physical Training and Low Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (<1 g/kg aBW/d)
10808271|NCT05224453|EG000|Reported Event|Physical Training and High Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d).
10808272|NCT05224453|EG001|Reported Event|Physical Training and Low Protein Diet|Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (<1 g/kg aBW/d)
10808277|NCT04537078|FG001|Participant Flow|the Flexible GnRh Antagonist|"This step will be done twice in two different cycles In each cycle: luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation using antagonist protocol will be used. Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Cetrotide ampule will be given daily as the biggest oocyte reaches size 14 mm. Decapeptyl ampules 0.2 mg will be administered when leading follicle >18 mm in diameter.Oocyte pickup will be done 36 hours after GnRh administration. Embryos of the first cycle will be vitrified . . While in the second cycle HCG triggering (Choriomon)in a dose of 10,000 IU will be administered when the leading follicle >18 mm in diameter. Oocyte pickup will be done 36 hours after GnRh administration . embryos of the second cycle will be freshly transferred unless there is excess so being verified for subsequent transfer.Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle.~."
10808278|NCT04537078|OG000|Outcome|the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration . The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Then, Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. .Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage.
10820922|NCT00063882|EG001|Reported Event|Brachytherapy Only|Transperineal interstitial permanent brachytherapy as 125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
10808279|NCT04537078|OG001|Outcome|the Flexible GnRh Antagonist Group|This step will be done twice in two different cycles In each cycle: luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation using antagonist protocol will be used. Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Cetrotide ampule will be given daily as the biggest oocyte reaches size 14 mm. Decapeptyl ampules 0.2 mg will be administered when leading follicle >18 mm in diameter.Oocyte pickup will be done 36 hours after GnRh administration. Embryos of the first cycle will be vitrified . While in the second cycle HCG triggering (Choriomon)in a dose of 10,000 IU will be administered when the leading follicle >18 mm in diameter. Oocyte pickup will be done 36 hours after GnRh administration . embryos of the second cycle will be freshly transferred unless there is excess so being verified for subsequent transfer.Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle.
10808280|NCT04537078|OG000|Outcome|the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration . The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Then, Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. .Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration The resultant embryos will be scored, and they will be vitrified for subsequent transfer.Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage.
10808281|NCT04537078|OG000|Outcome|the Follicular Phase of the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration. The resultant embryos will be scored, and they will be vitrified for subsequent transfer
10808282|NCT04537078|OG001|Outcome|the Luteal Phase of the Progestin Primed Double Stimulation Group|Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. .Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration The resultant embryos will be scored, and they will be vitrified for subsequent transfer
10808283|NCT04537078|OG000|Outcome|the Follicular Phase of the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration . The resultant embryos will be scored, and they will be vitrified for subsequent transfer
10808284|NCT04537078|OG001|Outcome|the Luteal Phase of the Progestin Primed Double Stimulation Group|Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration The resultant embryos will be scored, and they will be vitrified for subsequent transfer
10808285|NCT04537078|OG000|Outcome|The Follicular Phase of the Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering.Oocyte pickup will be done 36 hours after GnRh administration . The resultant embryos will be scored, and they will be vitrified for subsequent transfer
11205336|NCT02227836|EG000|Reported Event|Allergy Patch Testing APT|"Patient will undergo APT testing per the following protocol:~2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.~Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits~The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.~Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles)."
11205337|NCT02227849|BG000|Baseline|Canagliflozin (TA-7284) + GLP-1 Analogue|Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
11205338|NCT02227849|FG000|Participant Flow|Canagliflozin (TA-7284) + GLP-1 Analogue|Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
11205339|NCT02227849|OG000|Outcome|Canagliflozin (TA-7284) + GLP-1 Analogue|Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
11205340|NCT02227849|EG000|Reported Event|Canagliflozin (TA-7284) + GLP-1 Analogue|Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue
10820923|NCT00063934|BG000|Baseline|Neoadjuvant G3139, Doxorubicin and Docetaxel|Patients with locally advanced breast cancer received intravenous G3139 in combination with doxorubicin and docetaxel . Cycles were repeated every 21 days x 6.
10820924|NCT00063934|FG000|Participant Flow|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
10808286|NCT04537078|OG001|Outcome|the First Round of the Conventional GnRH Antagonist Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation using antagonist protocol will be used. Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Cetrotide ampule will be given daily as the biggest oocyte reaches size 14 mm. Decapeptyl ampules 0.2 mg will be administered when leading follicle >18 mm in diameter.Oocyte pickup will be done 36 hours after GnRh administration. Embryos of the first cycle will be vitrified
10808287|NCT04537078|EG000|Reported Event|the Progestin Primed Double Stimulation Group|luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Duphaston at 20 mg/day will be started from the first day of the ovulation induction.Decapeptyl in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter for triggering .Then, Controlled ovarian hyper-stimulation the next day after the previous oocyte pickup simultaneously with Duphaston. Starting from the next menstrual cycle Day 3, patients will receive oral estradiol valerate (Cyclo-Progynova (white tablets) daily.When endometrial thickness ≥ 7 mm.Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage.
10808288|NCT04537078|EG001|Reported Event|the Flexible GnRh Antagonist|This step will be done twice in two different cycles In each cycle: luteal phase priming using combined contraceptive pills from day 21 of the previous cycle for one week by Gynera tab. Controlled ovarian hyper-stimulation using antagonist protocol will be used. Stimulation with 225-375 IU of gonadotropins will be started day 2-3 of menses after vaginal ultrasound confirming the absence of ovarian cysts. Cetrotide ampule will be given daily as the biggest oocyte reaches size 14 mm. Decapeptyl ampules 0.2 mg will be administered when leading follicle >18 mm in diameter. While in the second cycle HCG triggering (Choriomon)in a dose of 10,000 IU will be administered when the leading follicle >18 mm in diameter. Embryo transfer will be scheduled on Day 3, 4 or 5 with maximum number of 3 class A embryos whether of cleavage or blastocyst stage that will be a mixture of the thawed embryos of the first cycle and fresh embryos of the second cycle.
10808289|NCT04425252|BG000|Baseline|Standard of Care|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19.
10808290|NCT04425252|BG001|Baseline|Standard of Care + Brequinar|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19 plus brequinar 100 mg daily x 5 days.
10808291|NCT04425252|BG002|Baseline|Total|Total of all reporting groups
10808292|NCT04425252|FG000|Participant Flow|Standard of Care|Subjects were hospitalized for COVID-19 and received standard of care per institutional guidelines for COVID-19 patients.
10808293|NCT04425252|FG001|Participant Flow|Standard of Care + Brequinar|Subjects were hospitalized for COVID-19 and received standard of care per institutional guidelines for COVID-19 patients plus brequinar 100 mg daily x 5 days.
10808294|NCT04425252|OG000|Outcome|Standard of Care|Subjects were hospitalized for COVID-19 and received standard of care per institutional guidelines for COVID-19 patients.
10808295|NCT04425252|OG001|Outcome|Standard of Care + Brequinar|Subjects were hospitalized for COVID-19 and received standard of care per institutional guidelines for COVID-19 patients plus brequinar 100 mg daily x 5 days.
10808296|NCT04425252|OG001|Outcome|Standard of Care + Brequinar|Subjects were hospitalized for COVID-19 and received standard of care per institutional guidelines for COVID-19 patients plus Brequinar 100 mg daily x 5 days.
10808297|NCT04425252|OG000|Outcome|Standard of Care|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19.
10808298|NCT04425252|OG001|Outcome|Standard of Care + Brequinar|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19 plus brequinar 100 mg daily x 5 days.
10808299|NCT04425252|EG000|Reported Event|Standard of Care|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19.
10808300|NCT04425252|EG001|Reported Event|Standard of Care + Brequinar|Subjects were hospitalized with COVID-19 and received institutional standard of care for COVID-19 plus brequinar 100 mg daily x 5 days.
10808301|NCT04368260|BG000|Baseline|All Study Participants|40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.
10808302|NCT04368260|FG000|Participant Flow|All Study Participants|40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject.
10808303|NCT04368260|OG000|Outcome|Control Swab|"FDA cleared swab~Control swab: FDA-cleared nasopharyngeal swab"
10808304|NCT04368260|OG001|Outcome|Prototype Swab|"Injection molded polypropylene flocked nylon NP swab~Prototype swab: Injection molded polypropylene flocked nylon nasopharyngeal swab"
10808305|NCT04368260|EG000|Reported Event|Control Swab|"FDA cleared swab~Control swab: FDA-cleared nasopharyngeal swab"
10808306|NCT04368260|EG001|Reported Event|Prototype Swab|"Injection molded polypropylene flocked nylon NP swab~Prototype swab: Injection molded polypropylene flocked nylon nasopharyngeal swab"
10820925|NCT00063934|OG000|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
10820926|NCT00063934|EG000|Reported Event|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
10820927|NCT00063986|BG000|Baseline|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
10820928|NCT00063986|FG000|Participant Flow|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
10808307|NCT03940326|BG000|Baseline|Levetiracetam|Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
10808308|NCT03940326|BG001|Baseline|Valproate|Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
10808309|NCT03940326|BG002|Baseline|Total|Total of all reporting groups
10808310|NCT03940326|FG000|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
10808311|NCT03940326|FG001|Participant Flow|Valproate|Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
10808312|NCT03940326|OG000|Outcome|Levetiracetam|Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
10808313|NCT03940326|OG001|Outcome|Valproate|Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
10808314|NCT03940326|EG000|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
10808315|NCT03940326|EG001|Reported Event|Valproate|Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
10808316|NCT03875313|BG000|Baseline|600 mg CB-839 + 1 mg Talazoparib|600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
10808317|NCT03875313|BG001|Baseline|800 mg CB-839 + 1 mg Talazoparib: ccRCC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
10808318|NCT03875313|BG002|Baseline|800 mg CB-839 + 1 mg Talazoparib: TNBC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
10808319|NCT03875313|BG003|Baseline|800 mg CB-839 + 1 mg Talazoparib: CRC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
10808320|NCT03875313|BG004|Baseline|800 mg CB-839 + 1 mg Talazoparib: Other Histology|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
10808321|NCT03875313|BG005|Baseline|Total|Total of all reporting groups
10808322|NCT03875313|FG000|Participant Flow|600 mg CB-839 + 1 mg Talazoparib|600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
10808323|NCT03875313|FG001|Participant Flow|800 mg CB-839 + 1 mg Talazoparib: ccRCC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received ≥ 2 prior systemic regimens including ≥ 1 vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy.
10808324|NCT03875313|FG002|Participant Flow|800 mg CB-839 + 1 mg Talazoparib: TNBC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic triple-negative breast cancer (TNBC) estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor receptor 2 (HER2)-negativewho received ≥ 1 prior line of cytotoxic chemotherapy with no prior poly adenosine diphosphate ribose polymerase (PARP) inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
10808325|NCT03875313|FG003|Participant Flow|800 mg CB-839 + 1 mg Talazoparib: CRC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic colorectal cancer (CRC) who received appropriate oxaliplatin or irinotecan- and fluorouracil (5-FU)-based chemotherapy with or without bevacizumab.
10808326|NCT03875313|FG004|Participant Flow|800 mg CB-839 + 1 mg Talazoparib: Other Histology|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
10808327|NCT03875313|OG000|Outcome|600 mg CB-839 + 1 mg Talazoparib|600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
10808328|NCT03875313|OG001|Outcome|800 mg CB-839 + 1 mg Talazoparib: ccRCC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
10808329|NCT03875313|OG002|Outcome|800 mg CB-839 + 1 mg Talazoparib: TNBC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
10808330|NCT03875313|OG003|Outcome|800 mg CB-839 + 1 mg Talazoparib: CRC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
10808331|NCT03875313|OG004|Outcome|800 mg CB-839 + 1 mg Talazoparib: Other Histology|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
10808332|NCT03875313|EG000|Reported Event|600 mg CB-839 + 1 mg Talazoparib|600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
11205341|NCT02228096|BG000|Baseline|Tisagenlecleucel (CTL019) - All Participants|Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
11205342|NCT02228096|BG001|Baseline|Not Infused|Pediatric patients with r/r B-cell who were enrolled in the study but not infused with tisagenlecleucel
11205343|NCT02228096|BG002|Baseline|Total|Total of all reporting groups
11205344|NCT02228096|FG000|Participant Flow|Tisagenlecleucel (CTL019) - All Participants|Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
10808333|NCT03875313|EG001|Reported Event|800 mg CB-839 + 1 mg Talazoparib: ccRCC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
10808334|NCT03875313|EG002|Reported Event|800 mg CB-839 + 1 mg Talazoparib: TNBC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
10808335|NCT03875313|EG003|Reported Event|800 mg CB-839 + 1 mg Talazoparib: CRC|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
10808336|NCT03875313|EG004|Reported Event|800 mg CB-839 + 1 mg Talazoparib: Other Histology|800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
10808337|NCT03694353|BG000|Baseline|All Subjects|Self administered subcutaneous pegvaliase injection using a prefilled syringe.
10808338|NCT03694353|FG000|Participant Flow|All Subjects|Self administered subcutaneous pegvaliase injection using a prefilled syringe.
10808339|NCT03694353|OG000|Outcome|All Subjects|Self administered subcutaneous pegvaliase injection using a prefilled syringe.
10808340|NCT03694353|EG000|Reported Event|All Subjects|Self administered subcutaneous pegvaliase injection using a prefilled syringe.
10808341|NCT03583554|BG000|Baseline|All Study Participants|All 12 study participants who started the study
10808342|NCT03583554|FG000|Participant Flow|Placebo, Then AV-101 720 mg, Then AV-101 1440 mg|Participants first received a single dose of oral placebo. After at least 3 days wash-out participants got a single dose of oral AV-101 720mg (matching placebo capsules). After at least 3 days wash-out participants got a single dose of oral AV-101 1440mg (matching placebo capsules).
10808343|NCT03583554|FG001|Participant Flow|AV-101 720 mg, Then AV-101 1440 mg, Then Placebo|Participants first received a single dose of oral AV-101 720mg (matching placebo capsules). After at least 3 days wash-out participants got a single dose of oral AV-101 1440mg (matching placebo capsules). After at least 3 days wash-out participants got a single dose of oral placebo.
10808344|NCT03583554|FG002|Participant Flow|AV-101 1440 mg, Then Placebo Then, AV-101 720 mg Then|Participants first received a single dose of oral AV-101 1440mg (matching placebo capsules). After at least 3 days wash-out participants got a single dose of oral placebo. After at least 3 days wash-out participants got a single dose of oral AV-101 720mg (matching placebo capsules).
10808345|NCT03583554|OG000|Outcome|Placebo|"Placebo~Placebo: Single dose of 4 placebo oral capsules"
10808346|NCT03583554|OG001|Outcome|AV-101 720 mg|"One time 720 mg L-4-Chlorokynurenine~AV-101 720 mg: Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules"
10808347|NCT03583554|OG002|Outcome|AV-101 1440 mg|"One time 1440 mg L-4-Chlorokynurenine~AV-101 1440 mg: Single dose of 4 360 mg AV-101 oral capsules"
11205345|NCT02228096|OG000|Outcome|Tisagenlecleucel (CTL019) - All Participants|Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
11205346|NCT02228096|OG000|Outcome|Tisagenlecleucel (CTL019) - Local Assessment|Pediatric participants with r/r B-cell ALL
10808348|NCT03583554|OG000|Outcome|Placebo|Outcomes across placebo
10808349|NCT03583554|OG001|Outcome|AV-101 720 mg|Outcomes across AV-101 720mg
10808350|NCT03583554|OG002|Outcome|AV-101 1440 mg|Outcomes across AV-101 1440mg
10808351|NCT03583554|EG000|Reported Event|Placebo|"Placebo~Placebo: Single dose of 4 placebo oral capsules"
10808352|NCT03583554|EG001|Reported Event|AV-101 720 mg|"One time 720 mg L-4-Chlorokynurenine~AV-101 720 mg: Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules"
10808353|NCT03583554|EG002|Reported Event|AV-101 1440 mg|"One time 1440 mg L-4-Chlorokynurenine~AV-101 1440 mg: Single dose of 4 360 mg AV-101 oral capsules"
10808354|NCT03538717|BG000|Baseline|Axitinib (INLYTA)|Participants with advanced or mRCC who had been treated with axitinib before inclusion in this study, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had a progression free survival of at least 9 months (long responders) or had disease progression as best response to this treatment (refractory). During this study, data for these participants was collected and observed retrospectively, for approximately 1 year.
11205347|NCT02228096|OG000|Outcome|Tisagenlecleucel (CTL019) - IRC Assessment|Pediatric participants with r/r B-cell ALL
11205348|NCT02228096|OG000|Outcome|Tisagenlecleucel (CTL019) - Per IRC Assessment|Pediatric participants with r/r B-cell ALL
11205349|NCT02228096|OG001|Outcome|Tisagenlecleucel (CTL019) - IRC Assessment|Pediatric participants with r/r B-cell ALL
11205350|NCT02228096|OG000|Outcome|CR/CRi|Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)
11205351|NCT02228096|OG001|Outcome|No Response (NR)|No response was defined as failure to attain the criteria needed for any response categories or relapse
11205352|NCT02228096|OG002|Outcome|Unknown|unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.
11205353|NCT02228096|OG001|Outcome|No Response|No response was defined as failure to attain the criteria needed for any response categories or relapse
11205354|NCT02228096|OG000|Outcome|Tisagenlecleucel - FAS Pts Who Achieved CR/CRi & Then Relapsed|Pediatric participants with r/r B-cell who were infused with tisagenlecleucel and then relapsed
11205355|NCT02228096|OG000|Outcome|NO CRS|No cytokine release syndrome
11205356|NCT02228096|OG001|Outcome|Grade 1/2|Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion
11205357|NCT02228096|OG002|Outcome|Grade 3|Grade 3 of cytokine release syndrome post tisagenlecleucel infusion
10808355|NCT03538717|FG000|Participant Flow|Axitinib (INLYTA)|Participants with advanced or mRCC who had been treated with axitinib before inclusion in this study, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had a progression free survival of at least 9 months (long responders) or had disease progression as best response to this treatment (refractory). During this study, data for these participants was collected and observed retrospectively, for approximately 1 year.
10808356|NCT03538717|OG000|Outcome|Long Responders to Axitinib|Participants with advanced or mRCC who had been treated with axitinib, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had a progression-free survival of at least 9 months with axitinib treatment. During this study, data for these participants was collected and observed, retrospectively for approximately 1 year.
10808357|NCT03538717|OG001|Outcome|Axitinib Refractory Participants|Participants with advanced or mRCC who had been treated with axitinib, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had disease progression as best response to this treatment and had disease progression at the first assessment after the initiation of treatment (estimated PFS was <=3 months). During this study, data for these participants was collected and observed, retrospectively for approximately 1 year.
10808358|NCT03538717|OG000|Outcome|Axitinib (INLYTA)|Participants with advanced or mRCC who had been treated with axitinib before inclusion in this study, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had a progression free survival of at least 9 months (long responders) or had disease progression as best response to this treatment (refractory). During this study, data for these participants was collected and observed retrospectively, for approximately 1 year.
10808359|NCT03538717|EG000|Reported Event|Axitinib (INLYTA)|Participants with advanced or mRCC who had been treated with axitinib before inclusion in this study, under standard clinical practice as a second-line treatment or further line as per its summary of product characteristics and had a progression free survival of at least 9 months (long responders) or had disease progression as best response to this treatment (refractory). During this study, data for these participants was collected and observed retrospectively, for approximately 1 year.
10808360|NCT03408873|BG000|Baseline|CAE-L|"Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention~Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.~Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers)."
10808361|NCT03408873|FG000|Participant Flow|CAE-L|"Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention~Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.~Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers)."
10808362|NCT03408873|OG000|Outcome|CAE-L|"Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention~Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.~Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers)."
10808363|NCT03408873|EG000|Reported Event|CAE-L|"Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention~Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.~Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers)."
10808364|NCT03132467|BG000|Baseline|Treatment (Tremelimumab, Durvalumab)|"Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
11205358|NCT02228096|OG003|Outcome|Grade 4|Grade 4 of cytokine release syndrome post tisagenlecleucel infusion
11205359|NCT02228096|OG004|Outcome|All Participants|All participants with & without CRS
10808365|NCT03132467|FG000|Participant Flow|Treatment (Tremelimumab, Durvalumab)|"Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
10808366|NCT03132467|OG000|Outcome|Treatment (Tremelimumab, Durvalumab)|"Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
10808367|NCT03132467|OG000|Outcome|Treatment (Tremelimumab, Durvalumab)|Participants with stage II or III HR+/HER2 negative breast cancer who were to receive neoadjuvant chemotherapy
10808368|NCT03132467|EG000|Reported Event|Treatment (Tremelimumab, Durvalumab)|"Patients were treated with durvalumab at a dose of 1500 mg and tremelimumab at a dose of 75 mg, both administered IV, for 2 cycles on days 1 and 28 Patients then received standard neoadjuvant chemotherapy prior to breast surgery Pre- and post-treatment tumor biopsies and blood samples were available for 5 out of 8 patients and were analyzed by CyTOF, IHC, and NanoString"
10820929|NCT00063986|OG000|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
11205360|NCT02228096|EG000|Reported Event|Tisagenlecleucel (CTL019) - All Participants|Pediatric participants with r/r B-cell who were infused with tisagenlecleucel
11205361|NCT02228174|BG000|Baseline|Sonata|Subjects treated with Sonata System.
11205362|NCT02228174|FG000|Participant Flow|Sonata|Subjects treated with the Sonata System.
10820930|NCT00063986|EG000|Reported Event|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
10820931|NCT00063999|BG000|Baseline|Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)|Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820932|NCT00063999|BG001|Baseline|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820933|NCT00063999|BG002|Baseline|Total|Total of all reporting groups
10820934|NCT00063999|FG000|Participant Flow|Doxorubicin, Cisplatin, Paclitaxel|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820935|NCT00063999|FG001|Participant Flow|Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820936|NCT00063999|OG000|Outcome|Arm I (Doxorubicin, Cisplatin, Paclitaxel)|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820937|NCT00063999|OG001|Outcome|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820938|NCT00063999|OG000|Outcome|Doxorubicin, Cisplatin, Paclitaxel|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
11205363|NCT02228174|OG000|Outcome|Subjects Treated With Sonata|Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.
11205364|NCT02228174|EG000|Reported Event|Sonata|Subjects treated with the Sonata System.
11205365|NCT02228395|BG000|Baseline|All Participants|Included all participants who received at least 1 dose of study treatment in any of the intervention periods
11205366|NCT02228395|FG000|Participant Flow|Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg|Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
11205367|NCT02228395|FG001|Participant Flow|PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg|Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
11205368|NCT02228395|FG002|Participant Flow|PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo|Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
11205369|NCT02228395|OG000|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
11205370|NCT02228395|OG001|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
11205371|NCT02228395|OG002|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
10808369|NCT03096288|BG000|Baseline|HPR - Evolocumab|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808370|NCT03096288|BG001|Baseline|HPR - Placebo|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808371|NCT03096288|BG002|Baseline|NPR - Evolocumab|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808372|NCT03096288|BG003|Baseline|NPR - Placebo|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808373|NCT03096288|BG004|Baseline|Total|Total of all reporting groups
10808374|NCT03096288|FG000|Participant Flow|HPR - Evolocumab|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808375|NCT03096288|FG001|Participant Flow|HPR - Placebo|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808376|NCT03096288|FG002|Participant Flow|NPR - Evolocumab|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808377|NCT03096288|FG003|Participant Flow|NPR - Placebo|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808378|NCT03096288|OG000|Outcome|HPR - Evolocumab|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808379|NCT03096288|OG001|Outcome|HPR - Placebo|Patients with high platelet reactivity (HPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808380|NCT03096288|OG002|Outcome|NPR - Evolocumab|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808381|NCT03096288|OG003|Outcome|NPR - Placebo|Patients with normal platelet reactivity (NPR) will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
10808382|NCT03096288|EG000|Reported Event|HPR - Evolocumab|"Evolocumab (Repatha) 420 mg s.c. single injection~Evolocumab: Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection)."
10808383|NCT03096288|EG001|Reported Event|HPR - Placebo|"0.9% sodium chloride s.c. single injection~Placebo: Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection)."
10808384|NCT03096288|EG002|Reported Event|NPR - Evolocumab|"Evolocumab (Repatha) 420 mg s.c. single injection~Evolocumab: Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection)."
10808385|NCT03096288|EG003|Reported Event|NPR - Placebo|"0.9% sodium chloride s.c. single injection~Placebo: Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection)."
10808386|NCT02919436|BG000|Baseline|Tamsulosin|"Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.~Tamsulosin: Active drug"
10808387|NCT02919436|BG001|Baseline|Placebo|"Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.~Placebo: Lactose-filled capsules identical to active drug"
10808388|NCT02919436|BG002|Baseline|Total|Total of all reporting groups
10808389|NCT02919436|FG000|Participant Flow|Tamsulosin|"Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.~Tamsulosin: Active drug"
10808390|NCT02919436|FG001|Participant Flow|Placebo|"Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.~Placebo: Lactose-filled capsules identical to active drug"
10808391|NCT02919436|OG000|Outcome|Tamsulosin|"Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.~Tamsulosin: Active drug"
10808392|NCT02919436|OG001|Outcome|Placebo|"Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.~Placebo: Lactose-filled capsules identical to active drug"
10808393|NCT02919436|OG000|Outcome|Preoperative Post-void Residual < 50 cc|Subjects in this group had a post-void residual greater than 50 cc in the preoperative office visit
10808394|NCT02919436|OG001|Outcome|Preoperative Post-void Residual >/= 50 cc|Subjects in this group had a post-void residual greater than or equal to 50 cc in the preoperative office visit
10808395|NCT02919436|EG000|Reported Event|Tamsulosin|"Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.~Tamsulosin: Active drug"
10808396|NCT02919436|EG001|Reported Event|Placebo|"Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.~Placebo: Lactose-filled capsules identical to active drug"
10808397|NCT02135484|BG000|Baseline|Alpharadin|"Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).~Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total)."
10808398|NCT02135484|FG000|Participant Flow|Alpharadin|"Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).~Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total)."
11205372|NCT02228395|OG003|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
10808399|NCT02135484|OG000|Outcome|Alpharadin|"Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).~Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total)."
10808400|NCT02135484|EG000|Reported Event|Alpharadin|"Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).~Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total)."
10808401|NCT02028884|BG000|Baseline|Placebo + Baseline Treatment|Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808402|NCT02028884|BG001|Baseline|Satralizumab + Baseline Treatment|Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808403|NCT02028884|BG002|Baseline|Total|Total of all reporting groups
10808404|NCT02028884|FG000|Participant Flow|Placebo + Baseline Treatment, Then Satralizumab|Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
11205373|NCT02228395|EG000|Reported Event|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
11205374|NCT02228395|EG001|Reported Event|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
11205375|NCT02228395|EG002|Reported Event|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
11205376|NCT02228395|EG003|Reported Event|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
11205377|NCT02228408|BG000|Baseline|Hydralazine/Isorsorbide Dinitrate|"Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Hydralazine/Isorsorbide Dinitrate: Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Target Dose:~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Dose Titration:~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects."
11205378|NCT02228408|BG001|Baseline|Placebo|"Placebo will be administered Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Placebo: Placebo titration will mimic titration of active study arm"
11205379|NCT02228408|BG002|Baseline|Total|Total of all reporting groups
11205380|NCT02228408|FG000|Participant Flow|Hydralazine/Isorsorbide Dinitrate|"Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Hydralazine/Isorsorbide Dinitrate: Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Target Dose:~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Dose Titration:~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects."
11205381|NCT02228408|FG001|Participant Flow|Placebo|"Placebo will be administered Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Placebo: Placebo titration will mimic titration of active study arm"
10820939|NCT00063999|OG001|Outcome|Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820940|NCT00063999|OG000|Outcome|Estrogen Receptor Positive|Patients with estrogen receptor positive tumors
10820941|NCT00063999|OG001|Outcome|Estrogen Receptor Negative|Patients with estrogen receptor negative tumors
11205382|NCT02228408|OG000|Outcome|Hydralazine/Isorsorbide Dinitrate|"Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Hydralazine/Isorsorbide Dinitrate: Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Target Dose:~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Dose Titration:~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects."
11205383|NCT02228408|OG001|Outcome|Placebo|"Placebo will be administered Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Placebo: Placebo titration will mimic titration of active study arm"
11205384|NCT02228408|EG000|Reported Event|Hydralazine/Isorsorbide Dinitrate|"Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Hydralazine/Isorsorbide Dinitrate: Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Target Dose:~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Dose Titration:~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects."
11205385|NCT02228408|EG001|Reported Event|Placebo|"Placebo will be administered Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Placebo: Placebo titration will mimic titration of active study arm"
11205386|NCT02228460|BG000|Baseline|GZ/SAR402671|GZ/SAR402671 15 mg once daily, orally for 26 weeks.
11205387|NCT02228460|FG000|Participant Flow|GZ/SAR402671|GZ/SAR402671 15 milligram (mg) once daily, orally for 26 weeks.
11205388|NCT02228460|OG000|Outcome|GZ/SAR402671|GZ/SAR402671 15 mg once daily, orally for 26 weeks.
11205389|NCT02228460|OG000|Outcome|GZ/SAR402671|GZ/SAR402671 15 mg once daily orally for 26 weeks.
11205390|NCT02228460|EG000|Reported Event|GZ/SAR402671|GZ/SAR402671 15 mg once daily, orally for 26 weeks.
11205391|NCT02228499|BG000|Baseline|Asthma|"children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205392|NCT02228499|BG001|Baseline|Controls|"Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205393|NCT02228499|BG002|Baseline|Total|Total of all reporting groups
11205394|NCT02228499|FG000|Participant Flow|Asthma|"children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205395|NCT02228499|FG001|Participant Flow|Controls|"Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205396|NCT02228499|OG000|Outcome|Asthma|"Children with asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205397|NCT02228499|OG001|Outcome|Controls|"Children with no history of asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205398|NCT02228499|EG000|Reported Event|Asthma|"children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205399|NCT02228499|EG001|Reported Event|Controls|"Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life~Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group."
11205400|NCT02228564|BG000|Baseline|LIFESTREAM™|"This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.~Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.~LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent"
11244296|NCT02509936|OG000|Outcome|Standard of Care Arm|"In this arm enrolled children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10820942|NCT00063999|OG002|Outcome|Progesterone Receptor Positive|Patients with progesterone receptor positive tumors
10820943|NCT00063999|OG003|Outcome|Progesterone Receptor Negative|Patients with progesterone receptor negative tumors
10808405|NCT02028884|FG001|Participant Flow|Satralizumab + Baseline Treatment, Then Satralizumab|Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808406|NCT02028884|OG000|Outcome|Placebo + Baseline Treatment|Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808407|NCT02028884|OG001|Outcome|Satralizumab + Baseline Treatment|Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808408|NCT02028884|OG000|Outcome|Satralizumab + Baseline Treatment|Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808409|NCT02028884|EG000|Reported Event|Placebo + Baseline Treatment, DB Period|Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment.
10808410|NCT02028884|EG001|Reported Event|Satralizumab + Baseline Treatment, DB Period|Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment.
10808411|NCT02028884|EG002|Reported Event|Placebo, Then Satralizumab, OLE Period|Following placebo treatment in the DB period participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD).
10808412|NCT02028884|EG003|Reported Event|Satralizumab, Then Satralizumab, OLE Period|Following satralizumab in the DB period participants continued satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD.
10808413|NCT01983774|BG000|Baseline|Esomeprazole|Esomeprazole 40 mg twice daily
10808414|NCT01983774|BG001|Baseline|Placebo|A matching placebo (sugar pill) to esomeprazole 40 mg twice daily.
10808415|NCT01983774|BG002|Baseline|Total|Total of all reporting groups
10808416|NCT01983774|FG000|Participant Flow|Esomeprazole|"Esomeprazole 40mg twice daily~Esomeprazole"
10808417|NCT01983774|FG001|Participant Flow|Placebo|"A matching placebo (sugar pill) to esomeprazole 40mg twice daily~Placebo: Sugar pill"
10808418|NCT01983774|OG000|Outcome|Esomeprazole|"Esomeprazole 40mg twice daily~Esomeprazole"
11205401|NCT02228564|FG000|Participant Flow|LIFESTREAM™|"This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.~Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.~LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent"
10808419|NCT01983774|OG001|Outcome|Placebo|"A matching placebo (sugar pill) to esomeprazole 40mg twice daily~Placebo: Sugar pill"
10808420|NCT01983774|OG000|Outcome|Esomeprazole|Esomeprazole 40mg twice daily
10808421|NCT01983774|OG001|Outcome|Placebo|A matching placebo (sugar pill) to esomeprazole 40mg twice daily
10808422|NCT01983774|EG000|Reported Event|Esomeprazole|"Esomeprazole 40mg twice daily~Esomeprazole"
10808423|NCT01983774|EG001|Reported Event|Placebo|"A matching placebo (sugar pill) to esomeprazole 40mg twice daily~Placebo: Sugar pill"
11205402|NCT02228564|OG000|Outcome|LIFESTREAM™|"This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.~Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.~LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent"
11205403|NCT02228564|EG000|Reported Event|LIFESTREAM™|"This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.~Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.~LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent"
10808424|NCT01974206|BG000|Baseline|Placebo|Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808425|NCT01974206|BG001|Baseline|ASP0113|Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808426|NCT01974206|BG002|Baseline|Total|Total of all reporting groups
10808427|NCT01974206|FG000|Participant Flow|Placebo|Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808428|NCT01974206|FG001|Participant Flow|ASP0113 5mg|Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808429|NCT01974206|OG000|Outcome|Placebo|Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808430|NCT01974206|OG001|Outcome|ASP0113 5mg|Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808431|NCT01974206|EG000|Reported Event|Placebo|Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808432|NCT01974206|EG001|Reported Event|ASP0113|Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
10808433|NCT01970865|BG000|Baseline|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808434|NCT01970865|BG001|Baseline|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808435|NCT01970865|BG002|Baseline|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808436|NCT01970865|BG003|Baseline|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808437|NCT01970865|BG004|Baseline|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808438|NCT01970865|BG005|Baseline|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808439|NCT01970865|BG006|Baseline|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808440|NCT01970865|BG007|Baseline|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808441|NCT01970865|BG008|Baseline|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808442|NCT01970865|BG009|Baseline|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808443|NCT01970865|BG010|Baseline|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808444|NCT01970865|BG011|Baseline|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808445|NCT01970865|BG012|Baseline|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808446|NCT01970865|BG013|Baseline|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808447|NCT01970865|BG014|Baseline|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808448|NCT01970865|BG015|Baseline|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808449|NCT01970865|BG016|Baseline|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
10808450|NCT01970865|BG017|Baseline|Total|Total of all reporting groups
10808451|NCT01970865|FG000|Participant Flow|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808452|NCT01970865|FG001|Participant Flow|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808453|NCT01970865|FG002|Participant Flow|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808454|NCT01970865|FG003|Participant Flow|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808455|NCT01970865|FG004|Participant Flow|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808456|NCT01970865|FG005|Participant Flow|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808457|NCT01970865|FG006|Participant Flow|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808458|NCT01970865|FG007|Participant Flow|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808459|NCT01970865|FG008|Participant Flow|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808460|NCT01970865|FG009|Participant Flow|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808461|NCT01970865|FG010|Participant Flow|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808462|NCT01970865|FG011|Participant Flow|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808463|NCT01970865|FG012|Participant Flow|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808464|NCT01970865|FG013|Participant Flow|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808465|NCT01970865|FG014|Participant Flow|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808466|NCT01970865|FG015|Participant Flow|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808467|NCT01970865|FG016|Participant Flow|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
10808468|NCT01970865|OG000|Outcome|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808469|NCT01970865|OG001|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808470|NCT01970865|OG002|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808471|NCT01970865|OG003|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808472|NCT01970865|OG004|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808473|NCT01970865|OG005|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808474|NCT01970865|OG006|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808475|NCT01970865|OG007|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808476|NCT01970865|OG008|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808477|NCT01970865|OG009|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808478|NCT01970865|OG000|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808479|NCT01970865|OG001|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808480|NCT01970865|OG002|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808481|NCT01970865|OG003|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808482|NCT01970865|OG004|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808483|NCT01970865|OG005|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808484|NCT01970865|OG000|Outcome|ALK Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
10808485|NCT01970865|OG001|Outcome|ROS1 Positive Population (Phase 1)|This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
10808486|NCT01970865|OG000|Outcome|Phase 1 ITT Population|This reporting group includes all Phase 1 participants in the ITT analysis set.
10808487|NCT01970865|OG001|Outcome|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808488|NCT01970865|OG002|Outcome|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808489|NCT01970865|OG003|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808490|NCT01970865|OG004|Outcome|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808491|NCT01970865|OG005|Outcome|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808492|NCT01970865|OG006|Outcome|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808493|NCT01970865|OG007|Outcome|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808494|NCT01970865|OG000|Outcome|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808495|NCT01970865|OG000|Outcome|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808496|NCT01970865|OG001|Outcome|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808497|NCT01970865|OG000|Outcome|Phase 1 PRO Evaluable Population|This reporting group includes all Phase 1 participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
10808498|NCT01970865|OG000|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808499|NCT01970865|OG001|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808500|NCT01970865|OG002|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808501|NCT01970865|OG003|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808502|NCT01970865|OG000|Outcome|Phase 2 ITT Population|This reporting group includes all Phase 2 participants in the ITT analysis set.
10808503|NCT01970865|OG000|Outcome|Phase 2 and Japan LIC PK Analysis Set|PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
10808504|NCT01970865|OG010|Outcome|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
11092252|NCT01538472|EG000|Reported Event|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
10808505|NCT01970865|OG011|Outcome|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808506|NCT01970865|OG012|Outcome|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808507|NCT01970865|OG013|Outcome|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808508|NCT01970865|OG014|Outcome|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808509|NCT01970865|OG015|Outcome|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808510|NCT01970865|EG000|Reported Event|10 mg QD (Phase 1)|PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808511|NCT01970865|EG001|Reported Event|25 mg QD (Phase 1)|PF-06463922 25 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808512|NCT01970865|EG002|Reported Event|50 mg QD (Phase 1)|PF-06463922 50 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808513|NCT01970865|EG003|Reported Event|75 mg QD (Phase 1)|PF-06463922 75 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808514|NCT01970865|EG004|Reported Event|100 mg QD (Phase 1)|PF-06463922 100 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808515|NCT01970865|EG005|Reported Event|150 mg QD (Phase 1)|PF-06463922 150 mg was orally given once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
10808516|NCT01970865|EG006|Reported Event|200 mg QD (Phase 1)|PF-06463922 200 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808517|NCT01970865|EG007|Reported Event|35 mg BID (Phase 1)|PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808518|NCT01970865|EG008|Reported Event|75 mg BID (Phase 1)|PF-06463922 75 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808519|NCT01970865|EG009|Reported Event|100 mg BID (Phase 1)|PF-06463922 100 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808520|NCT01970865|EG010|Reported Event|EXP-1 (Phase 2)|Treatment-naïve participants with advanced ALK-positive NSCLC with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808521|NCT01970865|EG011|Reported Event|EXP-2 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10820944|NCT00063999|OG000|Outcome|Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)|Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10808522|NCT01970865|EG012|Reported Event|EXP-3 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808523|NCT01970865|EG013|Reported Event|EXP-4 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808524|NCT01970865|EG014|Reported Event|EXP-5 (Phase 2)|Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808525|NCT01970865|EG015|Reported Event|EXP-6 (Phase 2)|Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally once daily (QD) on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
10808526|NCT01970865|EG016|Reported Event|Japan Lead-In Cohort (LIC)|Few Japanese participants were given PF-06463922 100 mg orally once daily (QD) in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal to evaluate safety of PF-06463922 in Japanese participants, in order to support inclusion of Japanese participants in Phase 2.
10808527|NCT00589420|BG000|Baseline|Sorafenib and Docetaxel|"All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks~docetaxel~sorafenib tosylate"
10808528|NCT00589420|FG000|Participant Flow|Phase II Trial of Sorafenib and Docetaxel|"All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks~docetaxel~sorafenib tosylate"
10808529|NCT00589420|OG000|Outcome|Phase II Trial of Sorafenib and Docetaxel|"All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks~docetaxel~sorafenib tosylate"
10808530|NCT00589420|EG000|Reported Event|Phase II Trial of Sorafenib and Docetaxel|"All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks~docetaxel~sorafenib tosylate"
10820945|NCT00063999|EG000|Reported Event|Arm I (Doxorubicin, Cisplatin, Paclitaxel)|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820946|NCT00063999|EG001|Reported Event|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
10820947|NCT00064025|BG000|Baseline|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
10820948|NCT00064025|FG000|Participant Flow|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
10820949|NCT00064025|OG000|Outcome|PR Negative (<=0.2)|
10820950|NCT00064025|OG001|Outcome|PR Positive (>0.2)|
10820951|NCT00064025|OG000|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
10820952|NCT00064025|EG000|Reported Event|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
10820953|NCT00064038|BG000|Baseline|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820954|NCT00064038|BG001|Baseline|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
10820955|NCT00064038|BG002|Baseline|Total|Total of all reporting groups
10820956|NCT00064038|FG000|Participant Flow|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820957|NCT00064038|FG001|Participant Flow|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
10847585|NCT00284050|BG000|Baseline|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10808531|NCT05043142|BG000|Baseline|Group One|One group study
10808532|NCT05043142|FG000|Participant Flow|Cross-sectional Study on COVID-19|"One group study included subjects who employed by one of the following organizations:~SI National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky.~Yuria-Pharm LLC.~Infuzia PJSC.~Institute Hyalual LLC.~Medical Center M.T.K. LLC.~InterChem SLC.~Diatom LLC."
10808533|NCT05043142|OG000|Outcome|Group One|One group study
10808534|NCT05043142|EG000|Reported Event|Group One|One group study
10820958|NCT00064038|FG002|Participant Flow|Crossover to Lenalidomide+Dexamethasone|"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.~Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10820959|NCT00064038|OG000|Outcome|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820960|NCT00064038|OG001|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
11215371|NCT02298946|OG000|Outcome|All Participants|"Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0 Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days~AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses.~Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days~Cyclophosphamide: 200mg/m(2) IV on day 0"
10820961|NCT00064038|OG002|Outcome|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820962|NCT00064038|OG000|Outcome|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820963|NCT00064038|EG000|Reported Event|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820964|NCT00064038|EG001|Reported Event|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
10820965|NCT00064038|EG002|Reported Event|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820966|NCT00064077|BG000|Baseline|Arm I (Paclitaxel, Cisplatin)|"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.~Cisplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10820967|NCT00064077|BG001|Baseline|Arm II (Vinorelbine, Cisplatin)|"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Vinorelbine Tartrate: Given IV"
10820968|NCT00064077|BG002|Baseline|Arm III (Gemcitabine, Cisplatin)|"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.~Cisplatin: Given IV~Gemcitabine Hydrochloride~Quality-of-Life Assessment: Ancillary studies"
10820969|NCT00064077|BG003|Baseline|Arm IV (Topotecan, Cisplatin)|"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Topotecan Hydrochloride: Given IV"
10820970|NCT00064077|BG004|Baseline|Total|Total of all reporting groups
10820971|NCT00064077|FG000|Participant Flow|Arm I (Paclitaxel, Cisplatin)|"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.~Cisplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10820972|NCT00064077|FG001|Participant Flow|Arm II (Vinorelbine, Cisplatin)|"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Vinorelbine Tartrate: Given IV"
11205404|NCT02228590|BG000|Baseline|APL-130277|At each dosing visit patients were assessed in a 'OFF' state by withholding their PD medication the night before, a dose of APL-130277 was administered. If the patient did not convert to a full 'ON' state within 3 hours and did not experience orthostatic hypotension, the next higher dose of APL-130277 was administered. If the patient did not turn ON with the next higher dose, levodopa was administered and completed their visit. Possible administered doses of APL-130277 were 10, 15, 20, 25 and 30 mg. Dosing Day 1: The starting dose was 10 mg APL-130277, and if no response 15 mg was administered. Dosing Day 2: Either the dose which elicited a response (i.e. an 'ON' state) at Day 1 was administered or the next higher dose (20 mg) was given. If no response occurred at 20 mg APL-130277, 25 mg was administered. Dosing Day 3: Either the dose which elicited a response at Day 2 was administered or the next higher dose (30 mg). If no response occurred at 30 mg the patient was discontinued.
10808535|NCT04993339|BG000|Baseline|Standard Surgery|Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
10808536|NCT04993339|BG001|Baseline|Standard Surgery With OOC|"Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention~OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels"
10808537|NCT04993339|BG002|Baseline|Total|Total of all reporting groups
10808538|NCT04993339|FG000|Participant Flow|Standard Surgery|Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
10808539|NCT04993339|FG001|Participant Flow|Standard Surgery With OOC|"Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention~OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels"
10808540|NCT04993339|OG000|Outcome|Standard Surgery|Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
10808541|NCT04993339|OG001|Outcome|Standard Surgery With OOC|"Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention~OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels"
10808542|NCT04993339|EG000|Reported Event|Standard Surgery|Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
10808543|NCT04993339|EG001|Reported Event|Standard Surgery With OOC|"Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention~OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels"
10808556|NCT04929522|BG000|Baseline|IANB/Inferior Alveolar Nerve Block|"patients were given a standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808557|NCT04929522|BG001|Baseline|IANB+IO|"patients were given a standard IANB (1.8 ml) followed by an intra-osseous supplemental injection (1.8 ml) Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808558|NCT04929522|BG002|Baseline|IANB+PDL|"patients were given a standard IANB (1.8 ml) followed by a PDL supplemental injection (1.8 ml) with Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808559|NCT04929522|BG003|Baseline|IANB+BI|"patients were given a standard IANB (1.8 ml) followed by a Buccal infiltration injection (1.8 ml) with Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808560|NCT04929522|BG004|Baseline|Total|Total of all reporting groups
10808561|NCT04929522|FG000|Participant Flow|IANB/Inferior Alveolar Nerve Block|"patients will be given standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808562|NCT04929522|FG001|Participant Flow|IANB+IO|"patients will be given standard IANB plus an intra-osseous with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808563|NCT04929522|FG002|Participant Flow|IANB+PDL|"patients will be given standard IANB plus a PDL injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808564|NCT04929522|FG003|Participant Flow|IANB+BI|"patients will be given standard IANB plus a BI injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808565|NCT04929522|OG000|Outcome|IANB/Inferior Alveolar Nerve Block|"patients were given a standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808566|NCT04929522|OG001|Outcome|IANB+IO|"patients were given a standard IANB (1.8 ml) followed by an intra-osseous injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808567|NCT04929522|OG002|Outcome|IANB+PDL|"patients were given standard IANB (1.8 ml) followed by a PDL injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808568|NCT04929522|OG003|Outcome|IANB+BI|"patients were given a standard IANB )1.8 ml) followed a Buccal Infiltration injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808569|NCT04929522|EG000|Reported Event|IANB/Inferior Alveolar Nerve Block|"patients will be given standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808570|NCT04929522|EG001|Reported Event|IANB+IO|"patients will be given standard IANB plus an intra-osseous with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808544|NCT04992442|BG000|Baseline|TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg|TAK-935 3×100 mg, tablets, orally, once on Day 1, followed by [14C]TAK-935 50 μg [approximately 1 μCi], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]TAK-935 300 mg (approximately 100 μCi) solution, orally, once on Day 1 of Treatment Period 2.
10808545|NCT04992442|FG000|Participant Flow|TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg|TAK-935 3×100 mg, tablets, orally, once on Day 1, followed by [14C]TAK-935 50 micrograms (μg) [approximately 1 μCi], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]TAK-935 300 mg (approximately 100 μCi) solution, orally, once on Day 1 of Treatment Period 2.
10808546|NCT04992442|OG000|Outcome|TAK-935 300 mg + [14C]TAK-935 50 μg|TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.
10808547|NCT04992442|OG000|Outcome|[14C]TAK-935 300 mg|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808548|NCT04992442|OG000|Outcome|[14C]TAK-935 50 μg|[14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days.
10808549|NCT04992442|OG000|Outcome|TAK-935 300 mg|TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1.
10808550|NCT04992442|OG000|Outcome|[14C]TAK-935 300 mg (Plasma)|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808551|NCT04992442|OG000|Outcome|[14C]TAK-935 300 mg (Urine)|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808552|NCT04992442|OG001|Outcome|[14C]TAK-935 300 mg (Feces)|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808553|NCT04992442|OG001|Outcome|[14C]TAK-935 300 mg|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808554|NCT04992442|EG000|Reported Event|TAK-935 300 mg + [14C]TAK-935 50 μg|TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.
10808555|NCT04992442|EG001|Reported Event|[14C]TAK-935 300 mg|[14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2.
10808571|NCT04929522|EG002|Reported Event|IANB+PDL|"patients will be given standard IANB plus a PDL injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808572|NCT04929522|EG003|Reported Event|IANB+BI|"patients will be given standard IANB plus a BI injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).~local anesthesia: technique for local anesthesia"
10808573|NCT04927858|BG000|Baseline|Overall Type 2 Diabetes Mellitus Population|This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.
10808574|NCT04927858|FG000|Participant Flow|Overall Type 2 Diabetes Mellitus Population|This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.
10808575|NCT04927858|OG000|Outcome|Overall Type 2 Diabetes Mellitus Population|This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.
10808576|NCT04927858|OG000|Outcome|Empagliflozin Type 2 Diabetes Mellitus Population|Patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).
10808577|NCT04927858|EG000|Reported Event|Overall Type 2 Diabetes Mellitus Population|This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.
10820973|NCT00064077|FG002|Participant Flow|Arm III (Gemcitabine, Cisplatin)|"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.~Cisplatin: Given IV~Gemcitabine Hydrochloride~Quality-of-Life Assessment: Ancillary studies"
10820974|NCT00064077|FG003|Participant Flow|Arm IV (Topotecan, Cisplatin)|"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Topotecan Hydrochloride: Given IV"
10820975|NCT00064077|OG000|Outcome|Arm I (Paclitaxel, Cisplatin)|"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.~Cisplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10820976|NCT00064077|OG001|Outcome|Arm II (Vinorelbine, Cisplatin)|"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Vinorelbine Tartrate: Given IV"
10820977|NCT00064077|OG002|Outcome|Arm III (Gemcitabine, Cisplatin)|"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.~Cisplatin: Given IV~Gemcitabine Hydrochloride~Quality-of-Life Assessment: Ancillary studies"
10820978|NCT00064077|OG003|Outcome|Arm IV (Topotecan, Cisplatin)|"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Topotecan Hydrochloride: Given IV"
10820979|NCT00064077|EG000|Reported Event|Arm I (Paclitaxel, Cisplatin)|"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.~Cisplatin: Given IV~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10820980|NCT00064077|EG001|Reported Event|Arm II (Vinorelbine, Cisplatin)|"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Vinorelbine Tartrate: Given IV"
10808578|NCT04919161|BG000|Baseline|Body Weight Support System Control Group|"In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.~Body weight support system control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808579|NCT04919161|BG001|Baseline|Body Weight Support System With Balance Perturbations|"Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.~Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level will be set based on the participant's progress."
10808580|NCT04919161|BG002|Baseline|Total|Total of all reporting groups
10808581|NCT04919161|FG000|Participant Flow|Body Weight Support System Control Group|"In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.~Body weight support system (BWSS) control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808582|NCT04919161|FG001|Participant Flow|Body Weight Support System With Balance Perturbations|"Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.~Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level will be set based on the participant's progress."
10808583|NCT04919161|OG000|Outcome|Body Weight Support System Control Group (BBS Pre-score)|In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
10808584|NCT04919161|OG001|Outcome|Body Weight Support System Control Group (BBS Post-score)|In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
10808585|NCT04919161|OG002|Outcome|Body Weight Support System With Balance Perturbations (BBS Pre-score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808586|NCT04919161|OG003|Outcome|Body Weight Support System With Balance Perturbations (BBS Post-score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808587|NCT04919161|OG000|Outcome|Body Weight Support System Control Group|In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system. The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
10820981|NCT00064077|EG002|Reported Event|Arm III (Gemcitabine, Cisplatin)|"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.~Cisplatin: Given IV~Gemcitabine Hydrochloride~Quality-of-Life Assessment: Ancillary studies"
10820982|NCT00064077|EG003|Reported Event|Arm IV (Topotecan, Cisplatin)|"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.~Cisplatin: Given IV~Quality-of-Life Assessment: Ancillary studies~Topotecan Hydrochloride: Given IV"
10808588|NCT04919161|OG001|Outcome|Body Weight Support System With Balance Perturbations|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808589|NCT04919161|OG000|Outcome|BWSS Control (Toilet Transfer Pre-Score)|"In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system.~The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808590|NCT04919161|OG001|Outcome|BWSS Control (Toilet Transfer Post-Score)|"In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system.~The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808591|NCT04919161|OG002|Outcome|BWSS-P (Toilet Transfer Pre-Score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808592|NCT04919161|OG003|Outcome|BWSS-P (Toilet Transfer Post-Score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808593|NCT04919161|OG000|Outcome|BWSS Control (Ambulation Pre-Score)|"In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system.~The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808594|NCT04919161|OG001|Outcome|BWSS Control (Ambulation Post-Score)|"In this arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system.~The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808595|NCT04919161|OG002|Outcome|BWSS-P (Ambulation Pre-Score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10808596|NCT04919161|OG003|Outcome|BWSS-P (Ambulation Post-Score)|"Similar to the control group arm, participants underwent normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. Additionally, this arm received eight balance perturbations, two in each direction (left lateral, right lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress."
10820983|NCT00064259|BG000|Baseline|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
10820984|NCT00064259|FG000|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
10808597|NCT04919161|OG000|Outcome|BWSS-P (Perturbation Level Progression) Session 1|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808598|NCT04919161|OG001|Outcome|BWSS-P (Perturbation Level Progression) Session 2|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808599|NCT04919161|OG002|Outcome|BWSS-P (Perturbation Level Progression) Session 3|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808600|NCT04919161|OG003|Outcome|BWSS-P (Perturbation Level Progression) Session 4|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808601|NCT04919161|OG004|Outcome|BWSS-P (Perturbation Level Progression) Session 5|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808602|NCT04919161|OG005|Outcome|BWSS-P (Perturbation Level Progression) Session 6|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10820985|NCT00064259|FG001|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
10820986|NCT00064259|FG002|Participant Flow|Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
11215372|NCT02298946|EG000|Reported Event|DL1 - CTX, SBRTx1 Day, & AMP-224|Dose Level 1 (DL1) Cyclophosphamide (CTX) 200mg/m(2) intravenous (IV) on day 0, stereotactic body radiation therapy (SBRT) 8 (gray)Gy x 1 day on day 0, AMP-224 10mg/kg on day 1 then every (q)14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
10808603|NCT04919161|OG006|Outcome|BWSS-P (Perturbation Level Progression) Session 7|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808604|NCT04919161|OG007|Outcome|BWSS-P (Perturbation Level Progression) Session 8|"As described in prior outcomes, BWSS-P participants underwent physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions. BWSS-P group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants started at perturbation level one and progressed up to level ten as appropriate. Each session, the perturbation level was set based on the participant's progress. For this secondary outcome, the highest perturbation level achieved was recorded after each study session to track the progression of the BWSS-P participants."
10808605|NCT04919161|OG000|Outcome|Body Weight Support System Control Group|"In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.~Body weight support system control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808606|NCT04919161|OG001|Outcome|Body Weight Support System With Balance Perturbations|"Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.~Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level will be set based on the participant's progress."
10808607|NCT04919161|EG000|Reported Event|Body Weight Support System Control Group|"In this arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system.~Body weight support system control group: The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions."
10808608|NCT04919161|EG001|Reported Event|Body Weight Support System With Balance Perturbations|"Similar to the control group arm, participants will undergo their normal physical therapy treatment while using the ZeroG body weight support system, with the inclusion of 8 total balance perturbations each session, including 2 in the posterior, anterior, left lateral, and right lateral directions.~Body weight support system with balance perturbations: The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level will be set based on the participant's progress."
10820987|NCT00064259|FG003|Participant Flow|Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
10820988|NCT00064259|OG000|Outcome|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
10820989|NCT00064259|OG000|Outcome|Treatment (Oblimersen Sodium)|"Phase I: Patients receive oblimersen IV continuously on days 1-7, fluorouracil IV continuously on days 4-8, and cisplatin IV on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD.~Phase II: Patients receive treatment as in phase I with oblimersen at the MTD.~oblimersen sodium: Given IV~cisplatin: Given IV~fluorouracil: Given IV"
10820990|NCT00064259|EG000|Reported Event|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
10820991|NCT00064298|BG000|Baseline|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
10820992|NCT00064298|BG001|Baseline|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
10820993|NCT00064298|BG002|Baseline|Total|Total of all reporting groups
10820994|NCT00064298|FG000|Participant Flow|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
10808609|NCT04912700|BG000|Baseline|Unvaccinated|Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
10808610|NCT04912700|BG001|Baseline|Partially Vaccinated|"Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or < 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or < 14 days after the administration of the single dose of viral vector vaccine (Johnson & Johnson).~COVID-19 vaccine: Full or partial reception of vaccine"
10808611|NCT04912700|BG002|Baseline|Fully Vaccinated|"Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset >14 days since administration of second dose of either mRNA vaccine, or >14 days since administration of viral vector vaccine (Johnson & Johnson).~COVID-19 vaccine: Full or partial reception of vaccine"
10808612|NCT04912700|BG003|Baseline|Total|Total of all reporting groups
10808613|NCT04912700|FG000|Participant Flow|Unvaccinated|Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
10808614|NCT04912700|FG001|Participant Flow|Partially Vaccinated|Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or < 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or < 14 days after the administration of the single dose of viral vector vaccine (Johnson & Johnson).
10808615|NCT04912700|FG002|Participant Flow|Fully Vaccinated|Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset >14 days since administration of second dose of either mRNA vaccine, or >14 days since administration of viral vector vaccine (Johnson & Johnson).
10808616|NCT04912700|OG000|Outcome|Unvaccinated|Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
10808617|NCT04912700|OG001|Outcome|Partially Vaccinated|Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or < 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or < 14 days after the administration of the single dose of viral vector vaccine (Johnson & Johnson).
10808618|NCT04912700|OG002|Outcome|Fully Vaccinated|Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset >14 days since administration of second dose of either mRNA vaccine, or >14 days since administration of viral vector vaccine (Johnson & Johnson).
10808619|NCT04912700|EG000|Reported Event|Unvaccinated|Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
10808620|NCT04912700|EG001|Reported Event|Partially Vaccinated|"Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or < 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or < 14 days after the administration of the single dose of viral vector vaccine (Johnson & Johnson).~COVID-19 vaccine: Full or partial reception of vaccine"
10808621|NCT04912700|EG002|Reported Event|Fully Vaccinated|"Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset >14 days since administration of second dose of either mRNA vaccine, or >14 days since administration of viral vector vaccine (Johnson & Johnson).~COVID-19 vaccine: Full or partial reception of vaccine"
10808622|NCT04912297|BG000|Baseline|PCV10 2+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808623|NCT04912297|BG001|Baseline|PCV10 3+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808624|NCT04912297|BG002|Baseline|Total|Total of all reporting groups
10808625|NCT04912297|FG000|Participant Flow|PCV10 2+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808626|NCT04912297|FG001|Participant Flow|PCV10 3+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808627|NCT04912297|OG000|Outcome|PCV10 2+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808628|NCT04912297|OG001|Outcome|PCV10 3+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10808629|NCT04912297|EG000|Reported Event|PCV10 2+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10820995|NCT00064298|FG001|Participant Flow|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
10820996|NCT00064298|OG000|Outcome|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
10808630|NCT04912297|EG001|Reported Event|PCV10 3+1 Schedule|"Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose).~10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10"
10820997|NCT00064298|OG001|Outcome|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
10820998|NCT00064298|EG000|Reported Event|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
10820999|NCT00064298|EG001|Reported Event|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
10821000|NCT00064337|BG000|Baseline|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
10821001|NCT00064337|FG000|Participant Flow|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
10821002|NCT00064337|OG000|Outcome|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
11205405|NCT02228590|FG000|Participant Flow|APL-130277|At each dosing visit patients were assessed in a 'OFF' state by withholding their PD medication the night before, a dose of APL-130277 was administered. If the patient did not convert to a full 'ON' state within 3 hours and did not experience orthostatic hypotension, the next higher dose of APL-130277 was administered. If the patient did not turn ON with the next higher dose, levodopa was administered and completed their visit. Possible administered doses of APL-130277 were 10, 15, 20, 25 and 30 mg. Dosing Day 1: The starting dose was 10 mg APL-130277, and if no response 15 mg was administered. Dosing Day 2: Either the dose which elicited a response (i.e. an 'ON' state) at Day 1 was administered or the next higher dose (20 mg) was given. If no response occurred at 20 mg APL-130277, 25 mg was administered. Dosing Day 3: Either the dose which elicited a response at Day 2 was administered or the next higher dose (30 mg). If no response occurred at 30 mg the patient was discontinued.
11215373|NCT02298946|EG001|Reported Event|DL2 - CTX, SBRTx3 Days, and AMP-224|Dose Level 2 (DL2) CTX 200mg/m(2) IV on day 0, SBRT 8Gy x 3 day on days -2, -1, 0, AMP-224 10mg/kg on day 1 then q14 days AMP-224: 10mg/kg on day 1 then every 14 days for a total of 6 doses. Stereotactic Body Radiation Therapy(SBRT): Dose Level 1: 8Gy x 1 day Dose Level 2: 8Gy x 3 days Cyclophosphamide: 200mg/m(2) IV on day 0
11215374|NCT02299050|BG000|Baseline|Cycloset|"Drug - Cycloset Cycloset 2.4 -3.2 mg/day~Other Names:~Bromocriptine Mesylate Quick Release~Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR"
10821003|NCT00064337|OG000|Outcome|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection:~MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year."
10821004|NCT00064337|EG000|Reported Event|PBSCC or Induction/PBSCC|Induction/PBSCC - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition
10821005|NCT00064337|EG001|Reported Event|Autologous Transplants|Autologous Transplants � All patients
10821006|NCT00064337|EG002|Reported Event|Dex/Thal|Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
10848159|NCT00288886|BG000|Baseline|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
10808631|NCT04910165|BG000|Baseline|Exparel|"Liposomal Bupivacaine use as active ingredient in the block~Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808632|NCT04910165|BG001|Baseline|Control|"Ropivacaine use as active ingredient in the block~Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808633|NCT04910165|BG002|Baseline|Total|Total of all reporting groups
10808634|NCT04910165|FG000|Participant Flow|Exparel|"Liposomal Bupivacaine use as active ingredient in the block~Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808635|NCT04910165|FG001|Participant Flow|Control|"Ropivacaine use as active ingredient in the block~Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808636|NCT04910165|OG000|Outcome|Exparel|"Liposomal Bupivacaine use as active ingredient in the block~Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808637|NCT04910165|OG001|Outcome|Control|"Ropivacaine use as active ingredient in the block~Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808638|NCT04910165|EG000|Reported Event|Exparel|"Liposomal Bupivacaine use as active ingredient in the block~Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808639|NCT04910165|EG001|Reported Event|Control|"Ropivacaine use as active ingredient in the block~Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine"
10808648|NCT04901897|BG000|Baseline|Kalifilcon A|"kalifilcon A daily disposable contact lens~kalifilcon A: kalifilcon A daily disposable contact lens"
10808649|NCT04901897|BG001|Baseline|Delefilcon A|"DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses~delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses"
10808650|NCT04901897|BG002|Baseline|Senofilcon A|"Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens~senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens"
10808651|NCT04901897|BG003|Baseline|Total|Total of all reporting groups
10808652|NCT04901897|FG000|Participant Flow|Kalifilcon A|"kalifilcon A daily disposable contact lens~kalifilcon A: kalifilcon A daily disposable contact lens"
10808653|NCT04901897|FG001|Participant Flow|Delefilcon A|"DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses~delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses"
10808654|NCT04901897|FG002|Participant Flow|Senofilcon A|"Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens~senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens"
10808655|NCT04901897|OG000|Outcome|Kalifilcon A|"kalifilcon A daily disposable contact lens~kalifilcon A: kalifilcon A daily disposable contact lens"
10808656|NCT04901897|OG001|Outcome|Delefilcon A|"DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses~delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses"
10808657|NCT04901897|OG002|Outcome|Senofilcon A|"Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens~senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens"
10808658|NCT04901897|EG000|Reported Event|Kalifilcon A|"kalifilcon A daily disposable contact lens~kalifilcon A: kalifilcon A daily disposable contact lens"
10808659|NCT04901897|EG001|Reported Event|Delefilcon A|"DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses~delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses"
10808660|NCT04901897|EG002|Reported Event|Senofilcon A|"Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens~senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens"
10808661|NCT04891874|BG000|Baseline|SBRT Group|"Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.~Stereotactic radiotherapy: Radiation using stereotactic radiotherapy device."
10808662|NCT04891874|BG001|Baseline|Surgery Alone Group|Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
10808663|NCT04891874|BG002|Baseline|Total|Total of all reporting groups
10808664|NCT04891874|FG000|Participant Flow|SBRT Group|"Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.~Stereotactic radiotherapy: Radiation using stereotactic radiotherapy device."
10808665|NCT04891874|FG001|Participant Flow|Surgery Alone Group|Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
10808666|NCT04891874|OG000|Outcome|SBRT Group|"Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.~Stereotactic radiotherapy: Radiation using stereotactic radiotherapy device."
10808667|NCT04891874|OG001|Outcome|Surgery Alone Group|Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
10808668|NCT04891874|EG000|Reported Event|SBRT Group|Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin. The AE like fatigue, vomitting, skin reaction and other items according to CTCAE5.0 will be recorded.
10808669|NCT04891874|EG001|Reported Event|Surgery Alone Group|Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
10808670|NCT04883541|BG000|Baseline|The Study Group|"Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.~yoga and meditation: The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation."
10808671|NCT04883541|BG001|Baseline|Control Group|"The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.~Birth preparation training: The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups."
10808640|NCT04904640|BG000|Baseline|Simulated Hips|Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning. The three stems are: CLS Zimmer (single wedge, tapered stem), Wagner Cone Zimmer (tapered stem), Aptafix Adler (anatomical stem)
10808641|NCT04904640|FG000|Participant Flow|Simulated Hips|Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.The Three stems are: CLS Zimmer, Wagner Cone Zimmer, Aptafix Adler
10808642|NCT04904640|OG000|Outcome|CLS Stem|"CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808643|NCT04904640|OG000|Outcome|Wagner Cone Stem|"Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808644|NCT04904640|OG000|Outcome|Aptafix Stem|"Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808645|NCT04904640|EG000|Reported Event|CLS Stem|"CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808646|NCT04904640|EG001|Reported Event|Wagner Cone Stem|"Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808647|NCT04904640|EG002|Reported Event|Aptafix Stem|"Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning~Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning."
10808672|NCT04883541|BG002|Baseline|Total|Total of all reporting groups
10808673|NCT04883541|FG000|Participant Flow|The Study Group|"Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.~yoga and meditation: The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation."
10808674|NCT04883541|FG001|Participant Flow|Control Group|"The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.~Birth preparation training: The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups."
10808675|NCT04883541|OG000|Outcome|The Study Group|"Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.~yoga and meditation: The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation."
10808676|NCT04883541|OG001|Outcome|Control Group|"The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.~Birth preparation training: The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups."
10808677|NCT04883541|EG000|Reported Event|The Study Group|"Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.~yoga and meditation: The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation."
10808678|NCT04883541|EG001|Reported Event|Control Group|"The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.~Birth preparation training: The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups."
10821007|NCT00064350|BG000|Baseline|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
10821008|NCT00064350|BG001|Baseline|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
10808679|NCT04881968|BG000|Baseline|Entire Study Population|"Each hospitalist in our study population 'crosses over' from control to intervention at a single time point by receiving a link to the Hopewell Hospitalist game via email and logging in to play the video game.~Hopewell Hospitalist Video Game: Hopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations."
10808680|NCT04881968|FG000|Participant Flow|Entire Study Population|"Each hospitalist in our study population 'crosses over' from control to intervention at a single time point by receiving a link to the Hopewell Hospitalist game via email and logging in to play the video game.~Hopewell Hospitalist Video Game: Hopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations."
10808681|NCT04881968|OG000|Outcome|Pre/Post Arms Combined|This covers both pre and post arms proposed in our study.
10808682|NCT04881968|EG000|Reported Event|Entire Study Population|Adverse events information was not collected during this study.
10808683|NCT04486560|BG000|Baseline|Single Arm: Cryoprobe|"Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.~ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath"
10808684|NCT04486560|FG000|Participant Flow|Single Arm: Cryoprobe|"Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.~ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath"
10808685|NCT04486560|OG000|Outcome|Single Arm: Cryoprobe|"Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.~ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath"
10808686|NCT04486560|EG000|Reported Event|Single Arm: Cryoprobe|"Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.~ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath"
10808687|NCT04357782|BG000|Baseline|Mild Hypoxemia|"S/F ratio >250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808688|NCT04357782|BG001|Baseline|Severe Hypoxemia|"S/F ratio ≤250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808689|NCT04357782|BG002|Baseline|Total|Total of all reporting groups
10808690|NCT04357782|FG000|Participant Flow|Mild Hypoxemia|"S/F ratio >250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808691|NCT04357782|FG001|Participant Flow|Severe Hypoxemia|"S/F ratio ≤250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808692|NCT04357782|OG000|Outcome|Mild Hypoxemia|"S/F ratio >250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808693|NCT04357782|OG001|Outcome|Severe Hypoxemia|"S/F ratio ≤250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808694|NCT04357782|EG000|Reported Event|Mild Hypoxemia|"S/F ratio >250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808695|NCT04357782|EG001|Reported Event|Severe Hypoxemia|"S/F ratio ≤250 prior to Vitamin C infusion~L-ascorbic acid: 50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)"
10808696|NCT04090658|BG000|Baseline|RSV_PreF3_AS01B Group|Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.
10808697|NCT04090658|BG001|Baseline|Placebo Group|Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
10808698|NCT04090658|BG002|Baseline|Total|Total of all reporting groups
10808699|NCT04090658|FG000|Participant Flow|RSV_PreF3_AS01B Group|Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.
10808700|NCT04090658|FG001|Participant Flow|Placebo Group|Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
10808701|NCT04090658|OG000|Outcome|RSV_PreF3_AS01B Group|Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.
10808702|NCT04090658|OG001|Outcome|Placebo Group|Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
10808703|NCT04090658|EG000|Reported Event|RSV_PreF3_AS01B Group|Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.
10808704|NCT04090658|EG001|Reported Event|Placebo Group|Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
10808705|NCT03811028|BG000|Baseline|Dose Group 1|"SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808706|NCT03811028|BG001|Baseline|Dose Group 2|"SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808707|NCT03811028|BG002|Baseline|Total|Total of all reporting groups
10808708|NCT03811028|FG000|Participant Flow|Dose Group 1|"SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808709|NCT03811028|FG001|Participant Flow|Dose Group 2|"SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808710|NCT03811028|OG000|Outcome|Dose Group 1|SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104 SOBI003: weekly i.v. infusion
10808711|NCT03811028|OG001|Outcome|Dose Group 2|"SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808712|NCT03811028|OG000|Outcome|Dose Group 1|"SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808713|NCT03811028|EG000|Reported Event|Dose Group 1|"SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808714|NCT03811028|EG001|Reported Event|Dose Group 2|"SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104~SOBI003: weekly i.v. infusion"
10808715|NCT03760068|BG000|Baseline|MYL-1601D Product (100 U/mL)|"MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808716|NCT03760068|BG001|Baseline|FlexPen NovoLog® (100 U/mL)|"FlexPen NovoLog® (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808717|NCT03760068|BG002|Baseline|Total|Total of all reporting groups
10808718|NCT03760068|FG000|Participant Flow|MYL-1601D Product (100 U/mL)|"MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808719|NCT03760068|FG001|Participant Flow|FlexPen NovoLog® (100 U/mL)|"FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808720|NCT03760068|OG000|Outcome|MYL-1601D Product (100 U/mL)|"MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808721|NCT03760068|OG001|Outcome|FlexPen NovoLog® (100 U/mL)|"FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808722|NCT03760068|OG000|Outcome|MYL-1601D Product (100 U/mL)|"MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808723|NCT03760068|EG000|Reported Event|MYL-1601D Product (100 U/mL)|"MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808724|NCT03760068|EG001|Reported Event|FlexPen NovoLog® (100 U/mL)|"FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.~Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis."
10808725|NCT03742986|BG000|Baseline|HER2-negative, Including TNBC or HR-positive|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Paclitaxel 80mg/m^2: Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)"
10808726|NCT03742986|BG001|Baseline|HER2-positive, Independent of HR Status|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)~Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2: Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)~Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4~Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4"
10808727|NCT03742986|BG002|Baseline|Total|Total of all reporting groups
10808728|NCT03742986|FG000|Participant Flow|HER2-negative, Including TNBC or HR-positive|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Paclitaxel 80mg/m^2: Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)"
10808729|NCT03742986|FG001|Participant Flow|HER2-positive, Independent of HR Status|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)~Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2: Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)~Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4~Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4"
10808730|NCT03742986|OG000|Outcome|HER2-negative, Including TNBC or HR-positive|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Paclitaxel 80mg/m^2: Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)"
10847586|NCT00284050|BG001|Baseline|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10808731|NCT03742986|OG001|Outcome|HER2-positive, Independent of HR Status|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)~Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2: Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)~Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4~Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4"
10808732|NCT03742986|EG000|Reported Event|HER2-negative, Including TNBC or HR-positive|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Paclitaxel 80mg/m^2: Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)"
10808733|NCT03742986|EG001|Reported Event|HER2-positive, Independent of HR Status|"Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)~Doxorubicin 60mg/m^2: Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)~Cyclophosphamide 600mg/m^2: Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)~Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2: Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)~Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4~Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4"
10808734|NCT03628781|BG000|Baseline|Mehealth Portal With Integrated Behavioral Tools|Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts
10808735|NCT03628781|BG001|Baseline|Mehealth Portal With no Integrated Behavioral Tools|Patients in this arm will wait one year before getting access to the behavioral intervention features.
10808736|NCT03628781|BG002|Baseline|Total|Total of all reporting groups
10808737|NCT03628781|FG000|Participant Flow|Mehealth Portal With Integrated Behavioral Tools|Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for attention deficit hyperactivity disorder (ADHD) software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
10808738|NCT03628781|FG001|Participant Flow|Mehealth Portal With no Integrated Behavioral Tools|Patients in this arm will wait one year before getting access to the behavioral intervention features.
10808739|NCT03628781|OG000|Outcome|Mehealth Portal With Integrated Behavioral Tools|Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
10808740|NCT03628781|OG001|Outcome|Mehealth Portal With no Integrated Behavioral Tools|Patients in this arm will wait one year before getting access to the behavioral intervention features.
10808741|NCT03628781|EG000|Reported Event|Mehealth Portal With Integrated Behavioral Tools|Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
10808742|NCT03628781|EG001|Reported Event|Mehealth Portal With no Integrated Behavioral Tools|Patients in this arm will wait one year before getting access to the behavioral intervention features.
10808743|NCT03560206|BG000|Baseline|Family SWaP Intervention|"an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.~Family SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."
10808744|NCT03560206|BG001|Baseline|Usual Care|"The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.~usual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so."
10808745|NCT03560206|BG002|Baseline|Total|Total of all reporting groups
10808746|NCT03560206|FG000|Participant Flow|Family SWaP Intervention|"an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.~Family SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."
10808747|NCT03560206|FG001|Participant Flow|Usual Care|"The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.~usual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so."
10808748|NCT03560206|OG000|Outcome|Family SWaP Intervention|"an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.~Family SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."
10808749|NCT03560206|OG001|Outcome|Usual Care|"The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.~usual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so."
10808750|NCT03560206|EG000|Reported Event|Family SWaP Intervention|"an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.~Family SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."
10808751|NCT03560206|EG001|Reported Event|Usual Care|"The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.~usual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so."
10808752|NCT03340766|BG000|Baseline|Blinatumomab 9/28 µg/Day + Pembrolizumab|Participants in Cohort Ia received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment. Starting on Day 15 participants also received 200 mg pembrolizumab administered by IV infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
10808753|NCT03340766|BG001|Baseline|Blinatumomab 9/28/56 µg/Day + Pembrolizumab|Participants in Cohort IIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
10808754|NCT03340766|BG002|Baseline|Blinatumomab 9/28/112 µg/Day + Pembrolizumab|"Participants in Cohort IIIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.~Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808755|NCT03340766|BG003|Baseline|Total|Total of all reporting groups
10808756|NCT03340766|FG000|Participant Flow|Blinatumomab 9/28 µg/Day + Pembrolizumab|Participants in Cohort Ia received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment. Starting on Day 15 participants also received 200 mg pembrolizumab administered by IV infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
10808757|NCT03340766|FG001|Participant Flow|Blinatumomab 9/28/56 µg/Day + Pembrolizumab|Participants in Cohort IIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
10808758|NCT03340766|FG002|Participant Flow|Blinatumomab 9/28/112 µg/Day + Pembrolizumab|"Participants in Cohort IIIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.~Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808759|NCT03340766|OG000|Outcome|Blinatumomab 9/28 µg/Day + Pembrolizumab|Participants in Cohort Ia received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment. Starting on Day 15 participants also received 200 mg pembrolizumab administered by IV infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
10808760|NCT03340766|OG001|Outcome|Blinatumomab 9/28/56 µg/Day + Pembrolizumab|Participants in Cohort IIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
10808761|NCT03340766|OG002|Outcome|Blinatumomab 9/28/112 µg/Day + Pembrolizumab|"Participants in Cohort IIIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.~Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808762|NCT03340766|OG000|Outcome|Blinatumomab 9/28/112 µg/Day + Pembrolizumab|"Participants in Cohort IIIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.~Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808763|NCT03340766|OG000|Outcome|Blinatumomab 9 µg/Day|Participants received blinatumomab administered via a continuous intravenous infusion of 9 µg/day.
10808764|NCT03340766|OG001|Outcome|Blinatumomab 28 µg/Day|Participants received blinatumomab administered via a continuous intravenous infusion of 28 µg/day.
10808765|NCT03340766|OG002|Outcome|Blinatumomab 56 µg/Day|Participants received blinatumomab administered via a continuous intravenous infusion of 56 µg/day.
10808766|NCT03340766|OG003|Outcome|Blinatumomab 112 µg/Day|Participants received blinatumomab administered via a continuous intravenous infusion of 112 µg/day.
10808767|NCT03340766|OG000|Outcome|Blinatumomab + Pembrolizumab|"Participants received blinatumomab administered CIVI for 8 weeks followed by a 28-day treatment-free interval. The starting dose was 9 µg/day for the first 7 days then 28 µg/day for 7 days, and increased to a maximum of 56 μg/day in Cohort IIa, or to 112 μg/day in Cohort IIIa from Day 15.~Starting on day 15 in Cohort Ia, and on study day 19 in Cohorts IIa and IIIa, participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808768|NCT03340766|EG000|Reported Event|Blinatumomab 9/28 µg/Day + Pembrolizumab|Participants in Cohort Ia received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment. Starting on Day 15 participants also received 200 mg pembrolizumab administered by IV infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
11215375|NCT02299050|FG000|Participant Flow|Cycloset|"Drug - Cycloset Cycloset 2.4 -3.2 mg/day~Other Names:~Bromocriptine Mesylate Quick Release~Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR"
10808769|NCT03340766|EG001|Reported Event|Blinatumomab 9/28/56 µg/Day + Pembrolizumab|Participants in Cohort IIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
10808770|NCT03340766|EG002|Reported Event|Blinatumomab 9/28/112 µg/Day + Pembrolizumab|"Participants in Cohort IIIa received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.~Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles."
10808771|NCT03043599|BG000|Baseline|Combination Therapy|"Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.~Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).~Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.~Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks."
10808772|NCT03043599|FG000|Participant Flow|Combination Therapy|"Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.~Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).~Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.~Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks."
10847587|NCT00284050|BG002|Baseline|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10847588|NCT00284050|BG003|Baseline|Total|Total of all reporting groups
11215376|NCT02299050|OG000|Outcome|Cycloset|"Drug - Cycloset Cycloset 2.4 -3.2 mg/day~Other Names:~Bromocriptine Mesylate Quick Release~Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR"
10808773|NCT03043599|OG000|Outcome|Combination Therapy|"Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.~Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).~Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.~Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks."
10808774|NCT03043599|EG000|Reported Event|Combination Therapy|"Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.~Thoracic Radiation Therapy: All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).~Ipilimumab: Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.~Nivolumab: Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks."
10808775|NCT02706847|BG000|Baseline|Placebo|Participants received placebo once daily for 12 weeks.
10808776|NCT02706847|BG001|Baseline|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 12 weeks.
10808777|NCT02706847|BG002|Baseline|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 12 weeks.
10808778|NCT02706847|BG003|Baseline|Total|Total of all reporting groups
10808779|NCT02706847|FG000|Participant Flow|Placebo / Upadacitinib 15 mg|Participants randomized to receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily from Week 12 to Week 260.
10808780|NCT02706847|FG001|Participant Flow|Placebo / Upadacitinib 30 mg|Participants randomized to receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily from Week 12 to Week 260.
10808781|NCT02706847|FG002|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks followed by upadacitinib 15 mg once daily from Week 12 to Week 260.
10808782|NCT02706847|FG003|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks followed by upadacitinib 30 mg once daily from Week 12 to Week 260.
10808783|NCT02706847|OG000|Outcome|Placebo|Participants received placebo once daily for 12 weeks.
10808784|NCT02706847|OG001|Outcome|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 12 weeks.
10808785|NCT02706847|OG002|Outcome|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 12 weeks.
10808786|NCT02706847|EG000|Reported Event|Placebo: Weeks 1-12|Participants received placebo once daily for 12 weeks.
10808787|NCT02706847|EG001|Reported Event|Upadacitinib 15 mg: Weeks 1-12|Participants received upadacitinib 15 mg once daily for 12 weeks.
10808788|NCT02706847|EG002|Reported Event|Upadacitinib 30 mg: Weeks 1-12|Participants received upadacitinib 30 mg once daily for 12 weeks.
10808789|NCT02706847|EG003|Reported Event|Upadacitinib 15 mg: Weeks 1-24|Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg for 24 weeks and participants originally randomized to placebo who switched to upadacitinib 15 mg at Week 12 and received upadacitinib 15 mg for 12 weeks.
10808790|NCT02706847|EG004|Reported Event|Upadacitinib 30 mg: Weeks 1-24|Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg for 24 weeks and participants originally randomized to placebo who switched to upadacitinib 30 mg at Week 12 and received upadacitinib 30 mg for 12 weeks.
10808791|NCT02701777|BG000|Baseline|STDP|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Participants will complete 10 STDP study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808792|NCT02701777|BG001|Baseline|STDP + Training|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 10 STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808793|NCT02701777|BG002|Baseline|Sham STDP + Training|"Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.~Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808794|NCT02701777|BG003|Baseline|Multisite-STDP + Training|"Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours.~Baseline, post 20, and post 40 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Baseline and post 40 measurements will be collected for the following measurements:~ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.~Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL."
10808795|NCT02701777|BG004|Baseline|Total|Total of all reporting groups
10808796|NCT02701777|FG000|Participant Flow|STDP|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Participants will complete 10 STDP study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808797|NCT02701777|FG001|Participant Flow|STDP + Training|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 10 STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808798|NCT02701777|FG002|Participant Flow|Sham STDP + Training|"Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.~Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808799|NCT02701777|FG003|Participant Flow|Multisite-STDP + Training|"Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours.~Baseline, post 20, and post 40 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Baseline and post 40 measurements will be collected for the following measurements:~ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.~Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL."
10808800|NCT02701777|OG000|Outcome|STDP|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Participants will complete study visits each lasting ~2. Changes in TMS measurements in the form of motor evoked potentials (MEPs) will be measured before and after the 30 minute STDP intervention. The maximum voluntary contraction (MVC) will be measured using surface EMG before and after the 30 minute STDP intervention."
10847589|NCT00284050|FG000|Participant Flow|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10848177|NCT00288912|OG002|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
10808801|NCT02701777|OG001|Outcome|STDP + Training|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their hands and arms.~Participants will complete 10 STDP + Training study visits each lasting ~2. Baseline and post measurements will be collected.~The following measurements were collected:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurement, GRASSP, will measure changes in the time it takes to complete hand tasks."
10808802|NCT02701777|OG002|Outcome|Sham STDP + Training|"Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.~Training: The participant will be asked to perform exercises using their hands and arms.~Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.~Participants will complete 10 Sham STDP + Training study visits each lasting ~2.~Baseline and post measurements will be collected.~The following measurements were collected:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurement, GRASSP, will measure changes in the time it takes to complete hand tasks."
10808803|NCT02701777|OG003|Outcome|Multisite-STDP + Training|"Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours.~Baseline, post 20, and post 40 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Baseline and post 40 measurements will be collected for the following measurements:~ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.~Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL."
10808804|NCT02701777|OG000|Outcome|STDP|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Participants will complete 10 STDP study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808805|NCT02701777|OG001|Outcome|STDP + Training|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 10 STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808806|NCT02701777|OG002|Outcome|Sham STDP + Training|"Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.~Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10821009|NCT00064350|BG002|Baseline|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm.~To show baseline characteristics for eligible and treated patients in both the randomization phase (the most important part of this study) and the induction phase, this group contains the following patients:~eligible and treated patients who were not randomized (n=194)~randomized patients who were not eligible or did not start treatment in the randomization phase (n=24)~There were 218 patients in this group so the total number of patients is 299 and the entire cohort represents all eligible and treated patients in the induction phase."
10821010|NCT00064350|BG003|Baseline|Total|Total of all reporting groups
11215377|NCT02299050|EG000|Reported Event|Cycloset|"Drug - Cycloset Cycloset 2.4 -3.2 mg/day~Other Names:~Bromocriptine Mesylate Quick Release~Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR"
11215378|NCT02299076|BG000|Baseline|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
11215379|NCT02299076|BG001|Baseline|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
11215380|NCT02299076|BG002|Baseline|Total|Total of all reporting groups
11215381|NCT02299076|FG000|Participant Flow|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
11215382|NCT02299076|FG001|Participant Flow|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
11215383|NCT02299076|OG000|Outcome|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
11215384|NCT02299076|OG001|Outcome|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
11215385|NCT02299076|EG000|Reported Event|Usual Care With Minimal Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.~Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention."
11215386|NCT02299076|EG001|Reported Event|Usual Care With BE Incentives|"Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.~Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention."
11215387|NCT02299089|BG000|Baseline|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215388|NCT02299089|BG001|Baseline|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11215389|NCT02299089|BG002|Baseline|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215390|NCT02299089|BG003|Baseline|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11215391|NCT02299089|BG004|Baseline|Total|Total of all reporting groups
11215392|NCT02299089|FG000|Participant Flow|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215393|NCT02299089|FG001|Participant Flow|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11215394|NCT02299089|FG002|Participant Flow|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215395|NCT02299089|FG003|Participant Flow|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11215396|NCT02299089|OG000|Outcome|Sandostatin LAR 10 mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
11215397|NCT02299089|OG001|Outcome|Sandostatin LAR 30mg (Acromegaly)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
11215398|NCT02299089|OG002|Outcome|Sandostatin LAR 20 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
11215399|NCT02299089|OG003|Outcome|Sandostatin LAR 30 mg (NET)|Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
11215400|NCT02299089|OG000|Outcome|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215401|NCT02299089|OG001|Outcome|CAM2029 20 mg q4w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11215402|NCT02299089|OG002|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11215403|NCT02299089|OG003|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
11205406|NCT02228590|OG000|Outcome|APL-130277|At each dosing visit patients were assessed in a 'OFF' state by withholding their PD medication the night before, a dose of APL-130277 was administered. If the patient did not convert to a full 'ON' state within 3 hours and did not experience orthostatic hypotension, the next higher dose of APL-130277 was administered. If the patient did not turn ON with the next higher dose, levodopa was administered and completed their visit. Possible administered doses of APL-130277 were 10, 15, 20, 25 and 30 mg. Dosing Day 1: The starting dose was 10 mg APL-130277, and if no response 15 mg was administered. Dosing Day 2: Either the dose which elicited a response (i.e. an 'ON' state) at Day 1 was administered or the next higher dose (20 mg) was given. If no response occurred at 20 mg APL-130277, 25 mg was administered. Dosing Day 3: Either the dose which elicited a response at Day 2 was administered or the next higher dose (30 mg). If no response occurred at 30 mg the patient was discontinued.
11205407|NCT02228590|OG000|Outcome|APL-130277|At each of 3 dosing visits patients were assessed in a practically defined 'OFF' state after withholding their usual PD medications the night before and APL-130277 sublingual film was administered initially at 10 mg. If the patient did not convert to a full 'ON' state within 3 hours from initial dosing and did not experience orthostatic
11205408|NCT02228590|EG000|Reported Event|APL-130277|At each of 3 dosing visits patients were assessed in a practically defined 'OFF' state after withholding their usual PD medications the night before and APL-130277 sublingual film was administered initially at 10 mg. If the patient did not convert to a full 'ON' state within 3 hours from initial dosing and did not experience orthostatic
11205409|NCT02228681|BG000|Baseline|Everolimus and Letrozole|Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
11205410|NCT02228681|BG001|Baseline|Tamoxifen and Medroxyprogesterone Acetate|Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
11205411|NCT02228681|BG002|Baseline|Total|Total of all reporting groups
11205412|NCT02228681|FG000|Participant Flow|Everolimus and Letrozole|Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
11205413|NCT02228681|FG001|Participant Flow|Tamoxifen and Medroxyprogesterone Acetate|Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
11205414|NCT02228681|OG000|Outcome|Everolimus and Letrozole|Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
11205415|NCT02228681|OG001|Outcome|Tamoxifen and Medroxyprogesterone Acetate|Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
11205416|NCT02228681|EG000|Reported Event|Everolimus and Letrozole|Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
11205417|NCT02228681|EG001|Reported Event|Tamoxifen and Medroxyprogesterone Acetate|Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
11205418|NCT02228720|BG000|Baseline|Propel Nova Sinus Implant|Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
11205419|NCT02228720|FG000|Participant Flow|Propel Nova Sinus Implant|"Sinus stent with steroid coating (370 ug mometasone furoate)~Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)"
11205420|NCT02228720|OG000|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
11205421|NCT02228720|EG000|Reported Event|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
11205422|NCT02228824|BG000|Baseline|Very Low Nicotine Content Cigarettes|Very low nicotine content cigarettes: 0.07 mg nicotine delivery
11205423|NCT02228824|BG001|Baseline|Normal Nicotine Content Cigarettes|Normal nicotine content cigarettes: 0.8 mg nicotine delivery
11205424|NCT02228824|BG002|Baseline|Total|Total of all reporting groups
11205425|NCT02228824|FG000|Participant Flow|Very Low Nicotine Content Cigarettes|Very low nicotine content cigarettes: 0.07 mg nicotine delivery
11205426|NCT02228824|FG001|Participant Flow|Normal Nicotine Content Cigarettes|Normal nicotine content cigarettes: 0.8 mg nicotine delivery
11205427|NCT02228824|OG000|Outcome|Very Low Nicotine Content Cigarettes|Very low nicotine content cigarettes: 0.07 mg nicotine delivery
11205428|NCT02228824|OG001|Outcome|Normal Nicotine Content Cigarettes|Normal nicotine content cigarettes: 0.8 mg nicotine delivery
11205429|NCT02228824|EG000|Reported Event|Very Low Nicotine Content Cigarettes|Very low nicotine content cigarettes: 0.07 mg nicotine delivery
11205430|NCT02228824|EG001|Reported Event|Normal Nicotine Content Cigarettes|Normal nicotine content cigarettes: 0.8 mg nicotine delivery
11205431|NCT02228967|BG000|Baseline|Usual Care|Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.
11205432|NCT02228967|BG001|Baseline|SBIRT|"Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:~Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.~Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.~Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.~SBIRT: SBIRT is an opportunistic approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a teachable moment, are delivered a brief, motivational intervention matched to their level of risk."
11205433|NCT02228967|BG002|Baseline|Total|Total of all reporting groups
11205434|NCT02228967|FG000|Participant Flow|Usual Care|Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.
11215404|NCT02299089|OG004|Outcome|Sandostatin LAR (Acromegaly)|Period day -28 to day 0 All acromegaly patients and all treatment groups
11215405|NCT02299089|OG005|Outcome|Sandostain LAR (NET)|Period day-28 to 0 All NET patient and all treatment groups
11215406|NCT02299089|OG000|Outcome|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot"
11205435|NCT02228967|FG001|Participant Flow|SBIRT|"Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:~Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.~Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.~Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.~SBIRT: SBIRT is an opportunistic approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a teachable moment, are delivered a brief, motivational intervention matched to their level of risk."
11205436|NCT02228967|OG000|Outcome|Usual Care|Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.
11205437|NCT02228967|OG001|Outcome|SBIRT|"Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:~Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.~Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.~Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.~SBIRT: SBIRT is an opportunistic approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a teachable moment, are delivered a brief, motivational intervention matched to their level of risk."
11205438|NCT02228967|EG000|Reported Event|Usual Care|Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.
11205439|NCT02228967|EG001|Reported Event|SBIRT|"Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:~Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.~Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.~Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.~SBIRT: SBIRT is an opportunistic approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a teachable moment, are delivered a brief, motivational intervention matched to their level of risk."
11205440|NCT02228980|BG000|Baseline|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
11205441|NCT02228980|BG001|Baseline|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205442|NCT02228980|BG002|Baseline|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205443|NCT02228980|BG003|Baseline|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205444|NCT02228980|BG004|Baseline|Total|Total of all reporting groups
11205445|NCT02228980|FG000|Participant Flow|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
11205446|NCT02228980|FG001|Participant Flow|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205447|NCT02228980|FG002|Participant Flow|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205448|NCT02228980|FG003|Participant Flow|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205449|NCT02228980|OG000|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
11205450|NCT02228980|OG001|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205451|NCT02228980|OG002|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205452|NCT02228980|OG003|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205453|NCT02228980|OG001|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205454|NCT02228980|OG001|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205455|NCT02228980|OG002|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205456|NCT02228980|OG003|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205457|NCT02228980|EG000|Reported Event|Group 1|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
11205458|NCT02228980|EG001|Reported Event|Group 2|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205459|NCT02228980|EG002|Reported Event|Group 3|Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
11205460|NCT02228980|EG003|Reported Event|Group 4|Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
11215407|NCT02299089|OG001|Outcome|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot"
10808807|NCT02701777|OG000|Outcome|Multisite-STDP + Training|"Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours.~Baseline, post 20, and post 40 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Baseline and post 40 measurements will be collected for the following measurements:~ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.~Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL."
10808808|NCT02701777|EG000|Reported Event|STDP|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Participants will complete 10 STDP study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808809|NCT02701777|EG001|Reported Event|STDP + Training|"Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 10 STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10808810|NCT02701777|EG002|Reported Event|Sham STDP + Training|"Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.~Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours.~Baseline and post 10 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements."
10847590|NCT00284050|FG001|Participant Flow|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
11205461|NCT02229214|BG000|Baseline|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
11205462|NCT02229214|BG001|Baseline|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
11205463|NCT02229214|BG002|Baseline|Total|Total of all reporting groups
11205464|NCT02229214|FG000|Participant Flow|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
11205465|NCT02229214|FG001|Participant Flow|Placebo|"Days 1-28: Placebo~Sugar Pill"
11205466|NCT02229214|OG000|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
11205467|NCT02229214|OG001|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
11205468|NCT02229214|OG001|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
11205469|NCT02229214|OG001|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
11205470|NCT02229214|EG000|Reported Event|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
11205471|NCT02229214|EG001|Reported Event|Placebo|"Days 1-28: Placebo~Sugar Pill"
11205472|NCT02229227|BG000|Baseline|Albiglutide + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
11205473|NCT02229227|BG001|Baseline|Insulin Lispro + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
11205474|NCT02229227|BG002|Baseline|Total|Total of all reporting groups
11205475|NCT02229227|FG000|Participant Flow|Albiglutide + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
11205476|NCT02229227|FG001|Participant Flow|Insulin Lispro + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
11205477|NCT02229227|OG000|Outcome|Albiglutide + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
11205478|NCT02229227|OG001|Outcome|Insulin Lispro + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
11205479|NCT02229227|EG000|Reported Event|Albiglutide + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
11205480|NCT02229227|EG001|Reported Event|Insulin Lispro + Insulin Glargine|During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
11205481|NCT02229318|BG000|Baseline|FruitiVits|Daily administration of FruitiVits dietary supplement
10847591|NCT00284050|FG002|Participant Flow|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10848178|NCT00288912|EG000|Reported Event|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
10848179|NCT00288912|EG001|Reported Event|Arm 2|Usual Medical Care
11205482|NCT02229318|FG000|Participant Flow|FruitiVits|Daily administration of FruitiVits dietary supplement
11205483|NCT02229318|OG000|Outcome|FruitiVits|Daily administration of FruitiVits dietary supplement
11205484|NCT02229318|OG000|Outcome|FruitiVits|Administration of FruitiVits dietary supplement
11205485|NCT02229318|EG000|Reported Event|FruitiVits|Daily administration of FruitiVits dietary supplement
11205486|NCT02229383|BG000|Baseline|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
11205487|NCT02229383|BG001|Baseline|Placebo|Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
11205488|NCT02229383|BG002|Baseline|Total|Total of all reporting groups
11205489|NCT02229383|FG000|Participant Flow|Exenatide|Exenatide 2 milligram (mg) 1 time per week + titrated basal insulin glargine with or without metformin.
11205490|NCT02229383|FG001|Participant Flow|Placebo|Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
11205491|NCT02229383|OG000|Outcome|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
11205492|NCT02229383|OG001|Outcome|Placebo|Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
11205493|NCT02229383|EG000|Reported Event|Exenatide|Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
11205494|NCT02229383|EG001|Reported Event|Placebo|Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
11205495|NCT02229396|BG000|Baseline|Dapagliflozin + Placebo|Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205496|NCT02229396|BG001|Baseline|Exenatide + Dapagliflozin|Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205497|NCT02229396|BG002|Baseline|Exenatide + Placebo|Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
10808811|NCT02701777|EG003|Reported Event|Multisite-STDP + Training|"Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation.~Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time.~Training: The participant will be asked to perform exercises using their upper and lower extremities.~Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours.~Baseline, post 20, and post 40 measurements will be collected for the following measurements:~Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG.~Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed.~Baseline and post 40 measurements will be collected for the following measurements:~ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions.~Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL."
10821011|NCT00064350|FG000|Participant Flow|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
10821012|NCT00064350|FG001|Participant Flow|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
10821013|NCT00064350|FG002|Participant Flow|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients in this group did not enter Step 2 (randomization part) after the induction phase."
10821014|NCT00064350|OG000|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
10821015|NCT00064350|OG001|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
10821016|NCT00064350|EG000|Reported Event|Induction: Sorafenib|All patients who received induction treatment (333 patients), regardless of eligibility status, were included in the toxicity analysis.
10821017|NCT00064350|EG001|Reported Event|Randomization (Step 2): Sorafenib|"After induction treatment, 59 patients were randomized to the sorafenib arm. Among these, 55 received treatment. However, due to drug dispensing error, 10 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 45 treated patients were included in the randomization (step 2): sorafenib group."
10821018|NCT00064350|EG002|Reported Event|Randomization (Step 2): Placebo|"After induction treatment, 46 patients were randomized to the placebo arm. Among these, 40 received treatment. However, due to drug dispensing error, 2 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 38 treated patients were included in the randomization (step 2): placebo group."
10821019|NCT00064350|EG003|Reported Event|Randomization (Step 2): Mixed|"After induction treatment, patients with stable disease were randomized to receive either sorafenib or placebo. Due to drug dispensing error, 10 patients from the sorafenib arm and 2 patients from the placebo arm (12 pts in total) received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities."
10821020|NCT00064350|EG004|Reported Event|Crossover: Sorafenib|Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
10821021|NCT00064662|BG000|Baseline|Burch|The Burch colposuspension
10821022|NCT00064662|BG001|Baseline|Sling|Pubovaginal sling, using autologous rectus fascia
10821023|NCT00064662|BG002|Baseline|Total|Total of all reporting groups
10821024|NCT00064662|FG000|Participant Flow|Burch|The Burch colposuspension
10821025|NCT00064662|FG001|Participant Flow|Sling|Pubovaginal sling, using autologous rectus fascia
10821026|NCT00064662|OG000|Outcome|Burch|The Burch colposuspension
10821027|NCT00064662|OG001|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
10821028|NCT00064662|EG000|Reported Event|Burch|The Burch colposuspension
10821029|NCT00064662|EG001|Reported Event|Sling|Pubovaginal sling, using autologous rectus fascia
11205498|NCT02229396|BG003|Baseline|Total|Total of all reporting groups
10808812|NCT02564900|BG000|Baseline|Dose Escalation: Cohort 1, 0.8 mg/kg|Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
10808813|NCT02564900|BG001|Baseline|Dose Escalation: Cohort 2, 1.6 mg/kg|Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
10808814|NCT02564900|BG002|Baseline|Dose Escalation: Cohort 3, 3.2 mg/kg|Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
10808815|NCT02564900|BG003|Baseline|Dose Escalation: Cohort 4, 5.4 mg/kg|Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808816|NCT02564900|BG004|Baseline|Dose Escalation: Cohort 5, 6.4 mg/kg|Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808817|NCT02564900|BG005|Baseline|Dose Escalation: Cohort 6, 8.0 mg/kg|Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
10808818|NCT02564900|BG006|Baseline|Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808819|NCT02564900|BG007|Baseline|Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808820|NCT02564900|BG008|Baseline|Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808821|NCT02564900|BG009|Baseline|Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808822|NCT02564900|BG010|Baseline|Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808823|NCT02564900|BG011|Baseline|Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808824|NCT02564900|BG012|Baseline|Dose Expansion: HER2-expressing NSCLC Tumors|Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808825|NCT02564900|BG013|Baseline|Dose Expansion: HER2-expressing Colorectal Tumors|Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808826|NCT02564900|BG014|Baseline|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808827|NCT02564900|BG015|Baseline|Total|Total of all reporting groups
10808828|NCT02564900|FG000|Participant Flow|Dose Escalation: Cohort 1, 0.8 mg/kg|Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
10808829|NCT02564900|FG001|Participant Flow|Dose Escalation: Cohort 2, 1.6 mg/kg|Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
10808830|NCT02564900|FG002|Participant Flow|Dose Escalation: Cohort 3, 3.2 mg/kg|Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
10808831|NCT02564900|FG003|Participant Flow|Dose Escalation: Cohort 4, 5.4 mg/kg|Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808832|NCT02564900|FG004|Participant Flow|Dose Escalation: Cohort 5, 6.4 mg/kg|Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808833|NCT02564900|FG005|Participant Flow|Dose Escalation: Cohort 6, 8.0 mg/kg|Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
10808834|NCT02564900|FG006|Participant Flow|Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808835|NCT02564900|FG007|Participant Flow|Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808836|NCT02564900|FG008|Participant Flow|Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808837|NCT02564900|FG009|Participant Flow|Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808838|NCT02564900|FG010|Participant Flow|Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808839|NCT02564900|FG011|Participant Flow|Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808840|NCT02564900|FG012|Participant Flow|Dose Expansion: HER2-expressing NSCLC Tumors|Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808841|NCT02564900|FG013|Participant Flow|Dose Expansion: HER2-expressing Colorectal Tumors|Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808842|NCT02564900|FG014|Participant Flow|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808843|NCT02564900|OG000|Outcome|Dose Escalation: Cohort 1, 0.8 mg/kg|Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
10808844|NCT02564900|OG001|Outcome|Dose Escalation: Cohort 2, 1.6 mg/kg|Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
10808845|NCT02564900|OG002|Outcome|Dose Escalation: Cohort 3, 3.2 mg/kg|Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
10808846|NCT02564900|OG003|Outcome|Dose Escalation: Cohort 4, 5.4 mg/kg|Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
11205499|NCT02229396|FG000|Participant Flow|Dapagliflozin + Placebo|Dapagliflozin 10 milligram (mg) tablet administered orally once daily + matching placebo for exenatide administered as subcutaneous (SC) injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205500|NCT02229396|FG001|Participant Flow|Exenatide + Dapagliflozin|Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205501|NCT02229396|FG002|Participant Flow|Exenatide + Placebo|Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
10808847|NCT02564900|OG004|Outcome|Dose Escalation: Cohort 5, 6.4 mg/kg|Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808848|NCT02564900|OG005|Outcome|Dose Escalation: Cohort 6, 8.0 mg/kg|Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
10808849|NCT02564900|OG006|Outcome|Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808850|NCT02564900|OG007|Outcome|Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808851|NCT02564900|OG008|Outcome|Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808852|NCT02564900|OG009|Outcome|Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808853|NCT02564900|OG010|Outcome|Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808854|NCT02564900|OG011|Outcome|Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808855|NCT02564900|OG012|Outcome|Dose Expansion: HER2-expressing NSCLC Tumors|Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808856|NCT02564900|OG013|Outcome|Dose Expansion: HER2-expressing Colorectal Tumors|Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808857|NCT02564900|OG014|Outcome|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808858|NCT02564900|OG000|Outcome|Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808859|NCT02564900|OG001|Outcome|Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808860|NCT02564900|OG002|Outcome|Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808861|NCT02564900|OG003|Outcome|Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808862|NCT02564900|OG004|Outcome|Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808863|NCT02564900|OG005|Outcome|Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808864|NCT02564900|OG006|Outcome|Dose Expansion: HER2-expressing NSCLC Tumors|Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808865|NCT02564900|OG007|Outcome|Dose Expansion: HER2-expressing Colorectal Tumors|Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808866|NCT02564900|OG008|Outcome|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808867|NCT02564900|OG012|Outcome|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808868|NCT02564900|OG013|Outcome|Dose Expansion: HER2-expressing Breast Cancer|Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
10808869|NCT02564900|EG000|Reported Event|Dose Escalation: Cohort 1, 0.8 mg/kg|Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
11205502|NCT02229396|OG000|Outcome|Dapagliflozin + Placebo|Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205503|NCT02229396|OG001|Outcome|Exenatide + Dapagliflozin|Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205504|NCT02229396|OG002|Outcome|Exenatide + Placebo|Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205505|NCT02229396|EG000|Reported Event|Dapagliflozin + Placebo|Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
10808870|NCT02564900|EG001|Reported Event|Dose Escalation: Cohort 2, 1.6 mg/kg|Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
10808871|NCT02564900|EG002|Reported Event|Dose Escalation: Cohort 3, 3.2 mg/kg|Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
10808872|NCT02564900|EG003|Reported Event|Dose Escalation: Cohort 4, 5.4 mg/kg|Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808873|NCT02564900|EG004|Reported Event|Dose Escalation: Cohort 5, 6.4 mg/kg|Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808874|NCT02564900|EG005|Reported Event|Dose Escalation: Cohort 6, 8.0 mg/kg|Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
10808875|NCT02564900|EG006|Reported Event|Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808876|NCT02564900|EG007|Reported Event|Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg|Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808877|NCT02564900|EG008|Reported Event|Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
10808878|NCT02564900|EG009|Reported Event|Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg|Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808879|NCT02564900|EG010|Reported Event|Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808880|NCT02564900|EG011|Reported Event|Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg|Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808881|NCT02564900|EG012|Reported Event|Dose Expansion: HER2-expressing Other Solid Tumors|Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
10808882|NCT02561299|BG000|Baseline|OA With Adjunctive DCB Angioplasty|"Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty~Peripheral Orbital Atherectomy System: Orbital Atherectomy~014 Drug Coated Balloon: Drug Coated Balloon"
10808883|NCT02561299|BG001|Baseline|DCB Angioplasty|"014 Drug Coated Balloon angioplasty~014 Drug Coated Balloon: Drug Coated Balloon"
10808884|NCT02561299|BG002|Baseline|Total|Total of all reporting groups
10808885|NCT02561299|FG000|Participant Flow|OA With Adjunctive DCB Angioplasty|"Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty~Peripheral Orbital Atherectomy System: Orbital Atherectomy~014 Drug Coated Balloon: Drug Coated Balloon"
10808886|NCT02561299|FG001|Participant Flow|DCB Angioplasty|"014 Drug Coated Balloon angioplasty~014 Drug Coated Balloon: Drug Coated Balloon"
10808887|NCT02561299|OG000|Outcome|OA With Adjunctive DCB Angioplasty|"Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty~Peripheral Orbital Atherectomy System: Orbital Atherectomy~014 Drug Coated Balloon: Drug Coated Balloon"
10808888|NCT02561299|OG001|Outcome|DCB Angioplasty|"014 Drug Coated Balloon angioplasty~014 Drug Coated Balloon: Drug Coated Balloon"
10808889|NCT02561299|EG000|Reported Event|OA With Adjunctive DCB Angioplasty|"Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty~Peripheral Orbital Atherectomy System: Orbital Atherectomy~014 Drug Coated Balloon: Drug Coated Balloon"
10808890|NCT02561299|EG001|Reported Event|DCB Angioplasty|"014 Drug Coated Balloon angioplasty~014 Drug Coated Balloon: Drug Coated Balloon"
10808891|NCT02548143|BG000|Baseline|Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg)|"Major surgical procedures were those that usually required ≥5 days of factor replacement in hemophilia patients with inhibitors and typically involved entry into a body cavity and/or organ removal or similarly complex procedures.~A dose of 200 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours after completion of the procedure. After 48 hours, dosing continued at 75 μg/kg of LR769 (not more frequently than every 2 hours) as follows:~Days 3-4: Intervals up to every 4 hours; Days 5-6: intervals up to every 6 hours; Days 7-10: Intervals up to every 8 hours; Days 11 to last administration of LR769: Intervals up to every 12 hours."
10808892|NCT02548143|BG001|Baseline|Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg)|"Minor surgical or other invasive procedures were those that usually required <5 days of factor replacement and usually involved the skin, mucous membranes, or superficial connective tissue. The minimum duration of LR769 infusion for minor procedures was 2 days. For less invasive procedures, the patient may have been treated for ≤48 hours if the investigator/designee determined a shorter duration was sufficient to achieve hemostasis.~A dose of 75 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours. From Day 3, dosing could continue at 75 μg/kg of LR769 at intervals of up to every 24 hours, but not more frequently than every 2 hours."
10808893|NCT02548143|BG002|Baseline|Total|Total of all reporting groups
10821030|NCT00064701|BG000|Baseline|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
11205506|NCT02229396|EG001|Reported Event|Exenatide + Dapagliflozin|Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
11205507|NCT02229396|EG002|Reported Event|Exenatide + Placebo|Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
10808894|NCT02548143|FG000|Participant Flow|Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg)|"Major surgical procedures were those that usually required ≥5 days of factor replacement in hemophilia patients with inhibitors and typically involved entry into a body cavity and/or organ removal or similarly complex procedures.~A dose of 200 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours after completion of the procedure. After 48 hours, dosing continued at 75 μg/kg of LR769 (not more frequently than every 2 hours) as follows:~Days 3-4: Intervals up to every 4 hours; Days 5-6: intervals up to every 6 hours; Days 7-10: Intervals up to every 8 hours; Days 11 to last administration of LR769: Intervals up to every 12 hours."
10808895|NCT02548143|FG001|Participant Flow|Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg)|"Minor surgical or other invasive procedures were those that usually required <5 days of factor replacement and usually involved the skin, mucous membranes, or superficial connective tissue. The minimum duration of LR769 infusion for minor procedures was 2 days. For less invasive procedures, the patient may have been treated for ≤48 hours if the investigator/designee determined a shorter duration was sufficient to achieve hemostasis.~A dose of 75 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours. From Day 3, dosing could continue at 75 μg/kg of LR769 at intervals of up to every 24 hours, but not more frequently than every 2 hours."
10808896|NCT02548143|OG000|Outcome|Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg)|"Major surgical procedures were those that usually required ≥5 days of factor replacement in hemophilia patients with inhibitors and typically involved entry into a body cavity and/or organ removal or similarly complex procedures.~A dose of 200 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours after completion of the procedure. After 48 hours, dosing continued at 75 μg/kg of LR769 (not more frequently than every 2 hours) as follows:~Days 3-4: Intervals up to every 4 hours; Days 5-6: intervals up to every 6 hours; Days 7-10: Intervals up to every 8 hours; Days 11 to last administration of LR769: Intervals up to every 12 hours."
10808897|NCT02548143|OG001|Outcome|Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg)|"Minor surgical or other invasive procedures were those that usually required <5 days of factor replacement and usually involved the skin, mucous membranes, or superficial connective tissue. The minimum duration of LR769 infusion for minor procedures was 2 days. For less invasive procedures, the patient may have been treated for ≤48 hours if the investigator/designee determined a shorter duration was sufficient to achieve hemostasis.~A dose of 75 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours. From Day 3, dosing could continue at 75 μg/kg of LR769 at intervals of up to every 24 hours, but not more frequently than every 2 hours."
10808898|NCT02548143|EG000|Reported Event|Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg)|"Major surgical procedures were those that usually required ≥5 days of factor replacement in hemophilia patients with inhibitors and typically involved entry into a body cavity and/or organ removal or similarly complex procedures.~A dose of 200 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours after completion of the procedure. After 48 hours, dosing continued at 75 μg/kg of LR769 (not more frequently than every 2 hours) as follows:~Days 3-4: Intervals up to every 4 hours; Days 5-6: intervals up to every 6 hours; Days 7-10: Intervals up to every 8 hours; Days 11 to last administration of LR769: Intervals up to every 12 hours."
10808899|NCT02548143|EG001|Reported Event|Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg)|"Minor surgical or other invasive procedures were those that usually required <5 days of factor replacement and usually involved the skin, mucous membranes, or superficial connective tissue. The minimum duration of LR769 infusion for minor procedures was 2 days. For less invasive procedures, the patient may have been treated for ≤48 hours if the investigator/designee determined a shorter duration was sufficient to achieve hemostasis.~A dose of 75 μg/kg of LR769 administered within ≤2 minutes of the onset of the procedure was used as the initial dose before the surgical incision or start of the invasive procedure. The initial dose was followed by repeated administration of 75 μg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours. From Day 3, dosing could continue at 75 μg/kg of LR769 at intervals of up to every 24 hours, but not more frequently than every 2 hours."
10808900|NCT02448680|BG000|Baseline|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
10808901|NCT02448680|BG001|Baseline|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
10808902|NCT02448680|BG002|Baseline|Total|Total of all reporting groups
10808903|NCT02448680|FG000|Participant Flow|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
10808904|NCT02448680|FG001|Participant Flow|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
10808905|NCT02448680|OG000|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10808906|NCT02448680|OG001|Outcome|FVIIa 225µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
10808907|NCT02448680|OG000|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Bleeding Episode
10808908|NCT02448680|OG001|Outcome|FVIIa 225 µg/kg|225 µg/kg Treatment Regimen at Time of Bleeding Episode
10808909|NCT02448680|EG000|Reported Event|Coagulation Factor VIIa (Recombinant): 75 µg/kg|"75 µg/kg treatment regimen for 3 months~Coagulation FVIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX"
10808910|NCT02448680|EG001|Reported Event|Coagulation Factor VIIa (Recombinant): 225 µg/kg|"225 µg/kg treatment regimen for 3 months~Coagulation FVIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX"
10808911|NCT02393859|BG000|Baseline|HC3 Chemotherapy|One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
10808912|NCT02393859|BG001|Baseline|Blinatumomab|One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
10808913|NCT02393859|BG002|Baseline|Total|Total of all reporting groups
10808914|NCT02393859|FG000|Participant Flow|HC3 Chemotherapy|One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day intravenous [IV] on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or intramuscularly [IM] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
10808915|NCT02393859|FG001|Participant Flow|Blinatumomab|One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
10808916|NCT02393859|OG000|Outcome|HC3 Chemotherapy|One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
10808917|NCT02393859|OG001|Outcome|Blinatumomab|One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
10808918|NCT02393859|OG000|Outcome|Blinatumomab|One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
10808919|NCT02393859|EG000|Reported Event|HC3 Chemotherapy|One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
10808920|NCT02393859|EG001|Reported Event|Blinatumomab|One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
10808921|NCT02352103|BG000|Baseline|Control Arm|"Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System~Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808922|NCT02352103|BG001|Baseline|Treatment Arm|"Retzius sparing radical prostatectomy da Vinci Surgical System~Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808923|NCT02352103|BG002|Baseline|Total|Total of all reporting groups
11092253|NCT01538615|BG000|Baseline|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
10808924|NCT02352103|FG000|Participant Flow|Control Arm|"Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System~Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808925|NCT02352103|FG001|Participant Flow|Treatment Arm|"Retzius sparing radical prostatectomy da Vinci Surgical System~Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808926|NCT02352103|OG000|Outcome|Control Arm|"Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System~Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808927|NCT02352103|OG001|Outcome|Treatment Arm|"Retzius sparing radical prostatectomy da Vinci Surgical System~Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808928|NCT02352103|EG000|Reported Event|Control Arm|"Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System~Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808929|NCT02352103|EG001|Reported Event|Treatment Arm|"Retzius sparing radical prostatectomy da Vinci Surgical System~Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique~da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."
10808930|NCT02273362|BG000|Baseline|Dose Level 0 ( 75 mg Erlotinib Hydrochloride Daily)|Patients receive 75 mg erlotinib hydrochloride PO QD for 7 days.
10808931|NCT02273362|BG001|Baseline|Dose Level -1 (50 mg Erlotinib Daily)|Patients receive 50 mg erlotinib hydrochloride PO QD for 7 days.
10808932|NCT02273362|BG002|Baseline|Dose Level -2 (25 mg Erlotinib Daily)|Patients receive 25 mg erlotinib hydrochloride PO QD for 7 days.
10808933|NCT02273362|BG003|Baseline|Total|Total of all reporting groups
10808934|NCT02273362|FG000|Participant Flow|Dose Level 0 ( 75 mg Erlotinib Hydrochloride Daily)|Patients receive 75 mg erlotinib hydrochloride PO QD for 7 days.
10808935|NCT02273362|FG001|Participant Flow|Dose Level -1 (50 mg Erlotinib Daily)|Patients receive 50 mg erlotinib hydrochloride PO QD for 7 days.
10808936|NCT02273362|FG002|Participant Flow|Dose Level -2 (25 mg Erlotinib Daily)|Patients receive 25 mg erlotinib hydrochloride PO QD for 7 days.
10808937|NCT02273362|OG000|Outcome|Dose Level 0 ( 75 mg Erlotinib Hydrochloride Daily)|Patients receive 75 mg erlotinib hydrochloride PO QD for 7 days.
10808938|NCT02273362|OG001|Outcome|Dose Level -1 (50 mg Erlotinib Daily)|Patients receive 50 mg erlotinib hydrochloride PO QD for 7 days.
10808939|NCT02273362|OG002|Outcome|Dose Level -2 (25 mg Erlotinib Daily)|Patients receive 25 mg erlotinib hydrochloride PO QD for 7 days.
10808940|NCT02273362|EG000|Reported Event|Dose Level 0 ( 75 mg Erlotinib Hydrochloride Daily)|Patients receive 75 mg erlotinib hydrochloride PO QD for 7 days.
10808941|NCT02273362|EG001|Reported Event|Dose Level -1 (50 mg Erlotinib Daily)|Patients receive 50 mg erlotinib hydrochloride PO QD for 7 days.
10808942|NCT02273362|EG002|Reported Event|Dose Level -2 (25 mg Erlotinib Daily)|Patients receive 25 mg erlotinib hydrochloride PO QD for 7 days.
10808943|NCT02178358|BG000|Baseline|150 mg Galunisertib Monotherapy|150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).
10808944|NCT02178358|BG001|Baseline|150 mg Galunisertib + 400 mg Sorafenib Therapy|"150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808945|NCT02178358|BG002|Baseline|400 mg Sorafenib + Placebo Therapy|"Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808946|NCT02178358|BG003|Baseline|Total|Total of all reporting groups
10808947|NCT02178358|FG000|Participant Flow|150 Milligram (mg) Galunisertib Monotherapy|150 mg galunisertib administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 days cycle).
10808948|NCT02178358|FG001|Participant Flow|150 mg Galunisertib + 400 mg Sorafenib Therapy|"150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808949|NCT02178358|FG002|Participant Flow|400 mg Sorafenib + Placebo Therapy|"Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808950|NCT02178358|OG000|Outcome|150 mg Galunisertib Monotherapy|150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).
10808951|NCT02178358|OG001|Outcome|150 mg Galunisertib + 400 mg Sorafenib Therapy|"150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808952|NCT02178358|OG002|Outcome|400 mg Sorafenib + Placebo Therapy|"Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808953|NCT02178358|OG000|Outcome|Galunisertib Monotherapy and Galunisertib + Sorafenib Therapy|"150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).~150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days."
10808954|NCT02178358|EG000|Reported Event|150 mg Galunisertib Monotherapy|150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).
10808955|NCT02178358|EG001|Reported Event|150 mg Galunisertib + 400 mg Sorafenib Therapy|"150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808956|NCT02178358|EG002|Reported Event|400 mg Sorafenib + Placebo Therapy|"Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).~400 mg sorafenib administered orally BID for 28 days."
10808957|NCT02073279|BG000|Baseline|Placebo|Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808958|NCT02073279|BG001|Baseline|Satralizumab|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808959|NCT02073279|BG002|Baseline|Total|Total of all reporting groups
10808960|NCT02073279|FG000|Participant Flow|Placebo, Then Satralizumab|Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808961|NCT02073279|FG001|Participant Flow|Satralizumab, Then Satralizumab|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808962|NCT02073279|OG000|Outcome|Placebo|Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808963|NCT02073279|OG001|Outcome|Satralizumab|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808964|NCT02073279|OG000|Outcome|Satralizumab|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
10808965|NCT02073279|EG000|Reported Event|Placebo, DB Period|Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse.
10808966|NCT02073279|EG001|Reported Event|Satralizumab, DB Period|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse.
10808967|NCT02073279|EG002|Reported Event|Placebo, Then Satralizumab, OLE Period|Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD).
10808968|NCT02073279|EG003|Reported Event|Satralizumab, Then Satralizumab, OLE Period|Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD).
10808969|NCT01544127|BG000|Baseline|MI-SI+TAU|"Motivational Interviewing to Address Suicidal Ideation (MI-SI)~MI-SI focuses on exploring and resolving ambivalence about living. It consist of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up session (30-50 mins)"
11286165|NCT02884492|EG000|Reported Event|Cognitive Impairment|"Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
10808970|NCT01544127|BG001|Baseline|MI-SI-R+TAU|"Motivational Interviewing to Address Suicidal Ideation Revised (MI-SI-R)~MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)"
10808971|NCT01544127|BG002|Baseline|Treatment as Usual (TAU)|"Treatment as Usual (TAU)~TAU consisted of standard inpatient treatment that includes medication management, case management, meals and a bed, and milieu therapy consisting of creative and social activities. Some families of veterans also received education to create a supportive home environment. Suicidal patients also completed a safety plan prior to discharge, and their care was overseen by a local Suicide Prevention Coordinator and case managers."
10808972|NCT01544127|BG003|Baseline|Total|Total of all reporting groups
10808973|NCT01544127|FG000|Participant Flow|MI-SI|Motivational interviewing to address suicidal ideation (MI-SI) is an adaptation of motivational interviewing that is focused on exploring and resolving ambivalence about living.
10808974|NCT01544127|FG001|Participant Flow|MI-SI-R|Motivational interviewing to address suicidal ideation revised (MI-SI-R) is an adaptation of motivational interviewing that is focused on resolving ambivalence about living.
10808975|NCT01544127|FG002|Participant Flow|VA TAU|Treatment as usual is standard treatment received during acute psychiatric hospitalization in a Department of Veterans Affairs (VA) medical center and after discharge.
10808976|NCT01544127|OG000|Outcome|MI-SI+TAU|"Motivational Interviewing to Address Suicidal Ideation~MI-SI+TAU: MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)"
10808977|NCT01544127|OG001|Outcome|MI-SI-R+TAU|"Motivational Interviewing to Address Suicidal Ideation Revised~MI-SI-R+TAU: MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)"
10808978|NCT01544127|OG002|Outcome|TAU Alone|"Treatment as usual~TAU: Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration(VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers."
10808979|NCT01544127|OG002|Outcome|TAU Alone|"Treatment as usual~TAU: Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of VHA suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers."
10808980|NCT01544127|EG000|Reported Event|MI-SI+TAU|"Motivational Interviewing to Address Suicidal Ideation~MI-SI+TAU: MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)"
10808981|NCT01544127|EG001|Reported Event|MI-SI-R+TAU|"Motivational Interviewing to Address Suicidal Ideation Revised~MI-SI-R+TAU: MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)"
10808982|NCT01544127|EG002|Reported Event|TAU Alone|"Treatment as usual~TAU: Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of VHA suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers."
10808983|NCT00806390|BG000|Baseline|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
10808984|NCT00806390|BG001|Baseline|Control|Not receiving metoprolol
10808985|NCT00806390|BG002|Baseline|Total|Total of all reporting groups
10808986|NCT00806390|FG000|Participant Flow|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
10808987|NCT00806390|FG001|Participant Flow|Control|Not receiving metoprolol
10808988|NCT00806390|OG000|Outcome|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
10808989|NCT00806390|OG001|Outcome|Control|Not receiving metoprolol
10808990|NCT00806390|EG000|Reported Event|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
10808991|NCT00806390|EG001|Reported Event|Control|Not receiving metoprolol
10808992|NCT00566618|BG000|Baseline|Phase I/Phase II|PhI/PhII- Dasatinib 70 mg twice daily/ dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle.
10808993|NCT00566618|FG000|Participant Flow|Phase I Dasatinib (70 mg)|Dasatinib 70 mg twice daily. Zoledronic acid was administered using standard dosing as a 15-minute intravenous infusion on day 1 of a 28-day cycle. Dasatinib was taken orally daily on days 1-28 of the cycle. Dasatinib was given continuously unless patients developed toxicities requiring dose adjustment or treatment interruption.
10808994|NCT00566618|FG001|Participant Flow|Phase 1 Dasatinib (100 mg)|Dasatinib (100 mg) daily. Zoledronic acid was administered using standard dosing as a 15-minute intravenous infusion on day 1 of a 28-day cycle. Dasatinib was taken orally daily on days 1-28 of the cycle. Dasatinib was given continuously unless patients developed toxicities requiring dose adjustment or treatment interruption.
10808995|NCT00566618|FG002|Participant Flow|Phase II Drug Administration|Dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle.
10808996|NCT00566618|OG000|Outcome|Phase I/Phase II|PhI/PhII-Open Label dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle
10808997|NCT00566618|OG000|Outcome|Phase I|Dasatinib 70 mg twice daily. Zoledronic acid was administered using standard dosing as a 15-minute intravenous infusion on day 1 of a 28-day cycle. Dasatinib was taken orally daily on days 1-28 of the cycle. Dasatinib was given continuously unless patients developed toxicities requiring dose adjustment or treatment interruption.
10808998|NCT00566618|EG000|Reported Event|Phase I/Phase II|PhI/PhII-Open Label dasatinib 100 mg daily in combination with zoledronic acid 4 mg IV on day 1 of a 28-day cycle
10808999|NCT00442559|BG000|Baseline|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809000|NCT00442559|BG001|Baseline|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809001|NCT00442559|BG002|Baseline|Total|Total of all reporting groups
11092254|NCT01538615|BG001|Baseline|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
11092255|NCT01538615|BG002|Baseline|Total|Total of all reporting groups
10809002|NCT00442559|FG000|Participant Flow|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
11205508|NCT02229461|BG000|Baseline|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205509|NCT02229461|BG001|Baseline|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205510|NCT02229461|BG002|Baseline|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205511|NCT02229461|BG003|Baseline|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205512|NCT02229461|BG004|Baseline|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205513|NCT02229461|BG005|Baseline|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
10809003|NCT00442559|FG001|Participant Flow|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809004|NCT00442559|OG000|Outcome|Daytime Asthma Symptom Score at Baseline - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809005|NCT00442559|OG001|Outcome|Daytime Asthma Symptom Score at 12 Weeks - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809006|NCT00442559|OG002|Outcome|Daytime Asthma Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809007|NCT00442559|OG003|Outcome|Daytime Asthma Symptom Score at 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809008|NCT00442559|OG000|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809009|NCT00442559|OG001|Outcome|Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
11205514|NCT02229461|BG006|Baseline|Non-Randomized|Fifteen participants were not randomized into Treatment Period.
11205515|NCT02229461|BG007|Baseline|Total|Total of all reporting groups
11205516|NCT02229461|FG000|Participant Flow|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205517|NCT02229461|FG001|Participant Flow|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205518|NCT02229461|FG002|Participant Flow|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205519|NCT02229461|FG003|Participant Flow|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11215408|NCT02299089|EG000|Reported Event|CAM2029 10 mg q2w (Acromegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot Day 0-84"
10809010|NCT00442559|OG002|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809011|NCT00442559|OG003|Outcome|Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809012|NCT00442559|EG000|Reported Event|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809013|NCT00442559|EG001|Reported Event|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
10809014|NCT00117338|BG000|Baseline|Montelukast Intravenous (IV) 5.25 mg|
10809015|NCT00117338|BG001|Baseline|Placebo|
10809016|NCT00117338|BG002|Baseline|Total|Total of all reporting groups
10809017|NCT00117338|FG000|Participant Flow|Montelukast Intravenous (IV) 5.25 mg|
10809018|NCT00117338|FG001|Participant Flow|Placebo|
10809019|NCT00117338|OG000|Outcome|Montelukast Intravenous (IV) 5.25 mg|
10809020|NCT00117338|OG001|Outcome|Placebo|
10809021|NCT00117338|EG000|Reported Event|Montelukast Intravenous (IV) 5.25 mg|
10809022|NCT00117338|EG001|Reported Event|Placebo|
10821031|NCT00064701|BG001|Baseline|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821032|NCT00064701|BG002|Baseline|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821033|NCT00064701|BG003|Baseline|Total|Total of all reporting groups
10821034|NCT00064701|FG000|Participant Flow|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821035|NCT00064701|FG001|Participant Flow|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821036|NCT00064701|FG002|Participant Flow|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821037|NCT00064701|OG000|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821038|NCT00064701|OG001|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821039|NCT00064701|OG002|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821040|NCT00064701|EG000|Reported Event|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821041|NCT00064701|EG001|Reported Event|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10809023|NCT04851314|BG000|Baseline|Maquet Flow-i C20|Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.
10809024|NCT04851314|BG001|Baseline|GE Aisys CS2|Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.
10809025|NCT04851314|BG002|Baseline|Total|Total of all reporting groups
10809026|NCT04851314|FG000|Participant Flow|Maquet Flow-i C20|Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
10809027|NCT04851314|FG001|Participant Flow|GE Aisys CS2|Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
10809028|NCT04851314|OG000|Outcome|Maquet Flow-i C20|Maquet Flow-i C20 (ICU certified ventilator): Examine anesthetic consumption rates
10809029|NCT04851314|OG001|Outcome|GE Aisys CS2|GE Aisys CS2 (Non-ICU certified ventilator): Examine anesthetic consumption rates
10809030|NCT04851314|EG000|Reported Event|Maquet Flow-i C20|Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
10809031|NCT04851314|EG001|Reported Event|GE Aisys CS2|Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
10809032|NCT04845633|BG000|Baseline|Healthy Children Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809033|NCT04845633|BG001|Baseline|Healthy Children Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809034|NCT04845633|BG002|Baseline|Children With Down Syndrome Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809035|NCT04845633|BG003|Baseline|Children With Down Syndrome Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809036|NCT04845633|BG004|Baseline|Total|Total of all reporting groups
10809037|NCT04845633|FG000|Participant Flow|Healthy Children Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
11205520|NCT02229461|FG004|Participant Flow|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
10809038|NCT04845633|FG001|Participant Flow|Healthy Children Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809039|NCT04845633|FG002|Participant Flow|Children With Down Syndrome Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809040|NCT04845633|FG003|Participant Flow|Children With Down Syndrome Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809041|NCT04845633|OG000|Outcome|Healthy Children Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809042|NCT04845633|OG001|Outcome|Healthy Children Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
11215409|NCT02299089|EG001|Reported Event|CAM2029 20 mg q4w (Acormegaly)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot Day 0-84"
10809043|NCT04845633|OG002|Outcome|Children With Down Syndrome Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809044|NCT04845633|OG003|Outcome|Children With Down Syndrome Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809045|NCT04845633|OG000|Outcome|Healthy Children Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809046|NCT04845633|OG001|Outcome|Healthy Children Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809047|NCT04845633|EG000|Reported Event|Healthy Children Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809048|NCT04845633|EG001|Reported Event|Healthy Children Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809049|NCT04845633|EG002|Reported Event|Children With Down Syndrome Using Conventional Toothbrush|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10809050|NCT04845633|EG003|Reported Event|Children With Down Syndrome Using Toothbrush With Customized Handle|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
10821042|NCT00064701|EG002|Reported Event|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
10821043|NCT00064753|BG000|Baseline|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821044|NCT00064753|BG001|Baseline|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821045|NCT00064753|BG002|Baseline|Total|Total of all reporting groups
10821046|NCT00064753|FG000|Participant Flow|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821047|NCT00064753|FG001|Participant Flow|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with estimated average requirement (EAR) amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821048|NCT00064753|OG000|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821049|NCT00064753|OG001|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821050|NCT00064753|EG000|Reported Event|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10809051|NCT04823494|BG000|Baseline|Pro-Fit Followed by Self-Fit|"Hearing aids initially fit by a professional hearing care provider using best practices and worn for 10-14 days. Devices then self-fit by participant and worn for 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809052|NCT04823494|BG001|Baseline|Self-Fit Followed by Pro-Fit|"Hearing aids self-fit by patient initially and worn for 10-14 days. Devices then fit by a professional hearing care provider using best practices and worn for another 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809053|NCT04823494|BG002|Baseline|Total|Total of all reporting groups
10809054|NCT04823494|FG000|Participant Flow|Pro-Fit Followed by Self-Fit|"Hearing aids fit by a professional hearing care provider using best practices, followed by a self-fit of both devices. There was a 10-14-day wear period following each fitting method.~Hearing aids: Earbud style hearing aids fit to both ears"
10809055|NCT04823494|FG001|Participant Flow|Self-Fit Followed by Pro-Fit|"Hearing aids self-fit by participant followed by the fitting of the devices by a professional hearing care provider using best practices. There was a 10-14-day wear period following each fitting method.~Hearing aids: Earbud style hearing aids fit to both ears"
10809056|NCT04823494|OG000|Outcome|Pro-Fit|"Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days prior to outcomes measurement.~Hearing aids: Earbud style hearing aids fit to both ears"
10809057|NCT04823494|OG001|Outcome|Self-Fit|"Hearing aids self-fit by participant and worn 10-14 days prior to outcomes measurement.~Hearing aids: Earbud style hearing aids fit to both ears"
10809058|NCT04823494|OG000|Outcome|Pro-Fit|"Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809059|NCT04823494|OG001|Outcome|Self-Fit|"Hearing aids fit by participants and worn for 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809060|NCT04823494|EG000|Reported Event|Pro-Fit|"Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809061|NCT04823494|EG001|Reported Event|Self-Fit|"Hearing aids self-fit by participant and worn for 10-14 days.~Hearing aids: Earbud style hearing aids fit to both ears"
10809068|NCT04814459|BG000|Baseline|HOP-UP-PT Program|"HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program~HOP-UP-PT Program: Interventions provided to HOP-UP-PT program participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented."
10809069|NCT04814459|BG001|Baseline|Normal Level of Activity|Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program
10809070|NCT04814459|BG002|Baseline|Total|Total of all reporting groups
10809071|NCT04814459|FG000|Participant Flow|HOP-UP-PT Program|"HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program~HOP-UP-PT Program: Interventions provided to HOP-UP-PT program participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented."
10809072|NCT04814459|FG001|Participant Flow|Normal Level of Activity|Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program
10809073|NCT04814459|OG000|Outcome|HOP-UP-PT Program|"HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program~HOP-UP-PT Program: Interventions provided to HOP-UP-PT program participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented."
10809074|NCT04814459|OG001|Outcome|Normal Level of Activity|Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program
10809075|NCT04814459|EG000|Reported Event|HOP-UP-PT Program|"HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program~HOP-UP-PT Program: Interventions provided to HOP-UP-PT program participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented."
10809076|NCT04814459|EG001|Reported Event|Normal Level of Activity|Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program
10809077|NCT04799782|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Mirtazapine (15 mg) or Placebo tablet
10809078|NCT04799782|FG000|Participant Flow|Placebo->Mirtazapine|Participants first received a placebo taken once daily for one week. After a washout period of one week, the participants then received mirtazapine taken once daily (15 mg) for one week.
11215410|NCT02299089|EG002|Reported Event|CAM2029 10 mg q2w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks~octreotide FluidCrystal® injection depot Day 0-84"
10809062|NCT04821245|BG000|Baseline|Overall Study|All enrolled subjects
10809063|NCT04821245|FG000|Participant Flow|Single Cohort|All volunteer patients
10809064|NCT04821245|OG000|Outcome|Participants Undergoing MRI|Number of Participants with Edema
10809065|NCT04821245|OG000|Outcome|CPK Analysis|CPK Levels Above High Normal
10809066|NCT04821245|OG001|Outcome|Aldolase Analysis|Aldolase Levels Above High Normal
10809067|NCT04821245|EG000|Reported Event|MRI Appearance|Volunteers undergoing MRI examination
10809079|NCT04799782|FG001|Participant Flow|Mirtazapine->Placebo|Participants first received mirtazapine taken once daily (15 mg) for one week. After a washout period of one week, the participants then received a placebo taken once daily for one week.
10809080|NCT04799782|OG000|Outcome|Mirtazapine|"The drug will be taken for a one week peroid.~Mirtazapine: 15 mg dose before bed-time"
10809081|NCT04799782|OG001|Outcome|Placebo|"The drug will be taken for a one week peroid.~Placebo: One placebo pill before bed-time"
10809082|NCT04799782|EG000|Reported Event|Mirtazapine|"The drug will be taken for a one week peroid.~Mirtazapine: 15 mg dose before bed-time"
10809083|NCT04799782|EG001|Reported Event|Placebo|"The drug will be taken for a one week peroid.~Placebo: One placebo pill before bed-time"
10821051|NCT00064753|EG001|Reported Event|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
10821052|NCT00064792|BG000|Baseline|Placebo Followed by Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
10821053|NCT00064792|BG001|Baseline|Simvastatin Followed by Placebo|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
10821054|NCT00064792|BG002|Baseline|Total|Total of all reporting groups
10821055|NCT00064792|FG000|Participant Flow|Placebo Followed by Simvastatin|Subjects maintained cholesterol intake of 150mg/kg/day for 12 months. After a 2 month wash out period, they then received Simvastatin 1mg/kg/day (after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol.
10821056|NCT00064792|FG001|Participant Flow|Simvastatin Followed by Placebo|Subjects first received Simvastatin (1mg/kg/day after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol 150mg/kg/day for 12 months. After a 2 month wash out period, they then continued with cholesterol supplementation only.
10821057|NCT00064792|OG000|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
10821058|NCT00064792|OG001|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
10821059|NCT00064792|EG000|Reported Event|OraPlus|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
10821060|NCT00064792|EG001|Reported Event|Simvastatin Susp|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
10821061|NCT00064844|BG000|Baseline|Nicotine Patch Plus Active Gum|
10821062|NCT00064844|BG001|Baseline|Nicotine Patch Plus Placebo Gum|
10821063|NCT00064844|BG002|Baseline|Total|Total of all reporting groups
10821064|NCT00064844|FG000|Participant Flow|Nicotine Patch Plus Active Gum|
10821065|NCT00064844|FG001|Participant Flow|Nicotine Patch Plus Placebo Gum|
10821066|NCT00064844|OG000|Outcome|Nicotine Patch Plus Active Gum|
10821067|NCT00064844|OG001|Outcome|Nicotine Patch Plus Placebo Gum|
10821068|NCT00064844|EG000|Reported Event|Nicotine Patch Plus Active Gum|
10821069|NCT00064844|EG001|Reported Event|Nicotine Patch Plus Placebo Gum|
10821070|NCT00064987|BG000|Baseline|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
10821071|NCT00064987|BG001|Baseline|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
10821072|NCT00064987|BG002|Baseline|Total|Total of all reporting groups
10821073|NCT00064987|FG000|Participant Flow|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
10821074|NCT00064987|FG001|Participant Flow|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
10821075|NCT00064987|OG000|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
10821076|NCT00064987|OG001|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
10821077|NCT00064987|EG000|Reported Event|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
10809084|NCT04780919|BG000|Baseline|Treatment Group (A)|"Group of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks. ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks.~BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300."
10809085|NCT04780919|BG001|Baseline|Sham Group (B)|"Group of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.~BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission."
10809086|NCT04780919|BG002|Baseline|Total|Total of all reporting groups
10809087|NCT04780919|FG000|Participant Flow|Treatment Group (A)|"Group of assigned patients with Achilles tendinopathy which were treated by focused extracorporeal shockwave therapy once a week for 5 weeks.~BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300."
10809088|NCT04780919|FG001|Participant Flow|Sham Group (B)|"Group of assigned patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.~BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission."
10809089|NCT04780919|OG000|Outcome|Treatment Group (A)|"Group of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks. ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks.~BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300."
10809090|NCT04780919|OG001|Outcome|Sham Group (B)|"Group of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.~BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission."
10809091|NCT04780919|OG000|Outcome|Treatment Group (A)|"Group of assigned patients with Achilles tendinopathy which were treated by focused extracorporeal shockwave therapy once a week for 5 weeks.~BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300."
10809092|NCT04780919|OG001|Outcome|Sham Group (B)|"Group of assigned patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.~BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission."
10809093|NCT04780919|EG000|Reported Event|Treatment Group (A)|"Group of assigned patients with Achilles tendinopathy which were treated by focused extracorporeal shockwave therapy once a week for 5 weeks.~BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300."
10809094|NCT04780919|EG001|Reported Event|Sham Group (B)|"Group of assigned patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.~BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission."
10821078|NCT00064987|EG001|Reported Event|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
10821079|NCT00065065|BG000|Baseline|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
10821080|NCT00065065|BG001|Baseline|Placebo|Identical in appearance to study drug taken twice a day
10821081|NCT00065065|BG002|Baseline|Total|Total of all reporting groups
11286166|NCT02884492|EG001|Reported Event|No Cognitive Impairment|"Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).~18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.~Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid."
10821082|NCT00065065|FG000|Participant Flow|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
10821083|NCT00065065|FG001|Participant Flow|Placebo|Placebo identical to study drug twice daily for 12 weeks
10821084|NCT00065065|OG000|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
10821085|NCT00065065|OG001|Outcome|Placebo|Identical in appearance to study drug taken twice a day
10821086|NCT00065065|OG000|Outcome|Rosiglitazone|"4 mg of rosiglitazone taken twice daily for 12 weeks.~Rosiglitazone: 4mg orally twice daily for 12 weeks"
10821087|NCT00065065|OG001|Outcome|Placebo|"Identical in appearance to study drug taken twice daily for 12 weeks.~Placebo: pill that looks identical to rosiglitazone"
10821088|NCT00065065|EG000|Reported Event|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
10821089|NCT00065065|EG001|Reported Event|Placebo|Identical in appearance to study drug taken twice a day
10821090|NCT00065156|BG000|Baseline|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
10821091|NCT00065156|FG000|Participant Flow|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
10809095|NCT04779606|BG000|Baseline|Chloroprocaine|"Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809096|NCT04779606|BG001|Baseline|Placebo|"Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809097|NCT04779606|BG002|Baseline|Total|Total of all reporting groups
10809098|NCT04779606|FG000|Participant Flow|Chloroprocaine|"Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809099|NCT04779606|FG001|Participant Flow|Placebo|"Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809100|NCT04779606|OG000|Outcome|Chloroprocaine|"Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809101|NCT04779606|OG001|Outcome|Placebo|"Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809102|NCT04779606|EG000|Reported Event|Chloroprocaine|"Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10809103|NCT04779606|EG001|Reported Event|Placebo|"Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.~Ocular gel: 3 drops instilled in the right eye"
10821092|NCT00065156|OG000|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
10821093|NCT00065156|EG000|Reported Event|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
10821094|NCT00065182|BG000|Baseline|IV Topotecan + IV Docetaxel|Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821095|NCT00065182|BG001|Baseline|IV Docetaxel|Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821096|NCT00065182|BG002|Baseline|Total|Total of all reporting groups
10821097|NCT00065182|FG000|Participant Flow|IV Topotecan + IV Docetaxel|Eligible participants received intravenous (IV) topotecan 3.5 milligrams per square meter per day (mg/m^2/day) and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821098|NCT00065182|FG001|Participant Flow|IV Docetaxel|Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (± 2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821099|NCT00065182|OG000|Outcome|IV Topotecan + IV Docetaxel|Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821100|NCT00065182|OG001|Outcome|IV Docetaxel|Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821101|NCT00065182|EG000|Reported Event|IV Topotecan + IV Docetaxel|Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821102|NCT00065182|EG001|Reported Event|IV Docetaxel|Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
10821103|NCT00065260|BG000|Baseline|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
11215411|NCT02299089|EG003|Reported Event|CAM2029 20 mg q4w (NET)|"CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly~octreotide FluidCrystal® injection depot Day 0-84"
11215412|NCT02299089|EG004|Reported Event|Sandostatin LAR (Acromegaly)|Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups
11215413|NCT02299089|EG005|Reported Event|Sandostatin LAR (NET)|Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups
11215414|NCT02299141|BG000|Baseline|Nintedanib|-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle
10809104|NCT04773028|BG000|Baseline|PATİENT GROUP(GROUP 1)|"This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809105|NCT04773028|BG001|Baseline|CONTROL GROUP(GROUP 2)|"This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809106|NCT04773028|BG002|Baseline|Total|Total of all reporting groups
10809107|NCT04773028|FG000|Participant Flow|PATİENT GROUP(GROUP 1)|"This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809108|NCT04773028|FG001|Participant Flow|CONTROL GROUP(GROUP 2)|"This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809109|NCT04773028|OG000|Outcome|PATİENT GROUP(GROUP 1)|"This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809110|NCT04773028|OG001|Outcome|CONTROL GROUP(GROUP 2)|"This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809111|NCT04773028|EG000|Reported Event|PATİENT GROUP(GROUP 1)|"This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809112|NCT04773028|EG001|Reported Event|CONTROL GROUP(GROUP 2)|"This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung.~matrix metalloproteinase enzymes 2 and 9: concentration of matrix metalloproteinase 2 and 9 enzymes"
10809113|NCT04755595|BG000|Baseline|Facial Aesthetic Treatment|"Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.~Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent~Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid~Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid"
10809114|NCT04755595|FG000|Participant Flow|Facial Aesthetic Treatment|"Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.~Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent~Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid~Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid"
10809115|NCT04755595|OG000|Outcome|Baseline|Baseline assessment of satisfaction of overall facial appearance.
10809116|NCT04755595|OG001|Outcome|Post-treatment|Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
10809117|NCT04755595|EG000|Reported Event|Facial Aesthetic Treatment|"Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.~Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent~Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid~Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid"
10809118|NCT04749745|BG000|Baseline|L-Theanine and Placebo Cross-over in All Subjects|Subject will receive 400mg single dose of L-theanine or Placebo, by oral ingestion with water. After 72 hours washout period, the same subject will then receive 400mg single dose of Placebo or L-theanine (opposite condition from the first dose). The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded. All subjects receive both conditions of drugs.
10821104|NCT00065260|BG001|Baseline|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
10821105|NCT00065260|BG002|Baseline|Total|Total of all reporting groups
10847592|NCT00284050|OG000|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10809119|NCT04749745|FG000|Participant Flow|L-Theanine First, Then Placebo|"Subject will receive 400mg single dose of L-theanine, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.~L-theanine: The subject will receive paired-pulse TMS (ppTMS) procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse is delivered by the coil, the EMG over a thumb muscle (abductor pollicis brevis) will record a motor-evoked potential on the tracing. Cross-over with placebo in two separate sessions at least 72 hours apart.~Placebo: The subject will receive ppTMS procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse is delivered, the EMG over the abductor pollicis brevis will record a motor-evoked potential on the tracing. Cross-over with L-theanine in two separate sessions at least 72 hours apart."
10809120|NCT04749745|FG001|Participant Flow|Placebo First, Then L-Theanine|"Subject will receive 400mg single dose of matching Placebo, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.~L-theanine: The subject will receive paired-pulse TMS (ppTMS) procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse is delivered by the coil, the EMG over a thumb muscle (abductor pollicis brevis) will record a motor-evoked potential on the tracing. Cross-over with placebo in two separate sessions at least 72 hours apart.~Placebo: The subject will receive ppTMS procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface EMG. The ppTMS procedure is administered by a TMS stimulator controlled a software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse is delivered by the coil, the EMG over the abductor pollicis brevis will record a motor-evoked potential on the tracing. Cross-over with L-theanine in two separate sessions at least 72 hours apart."
10809121|NCT04749745|OG000|Outcome|L-Theanine|"Subject will receive 400mg single dose of L-theanine, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.~The baseline-to-post-drug change of SICI, ICF and LICI elicited by L-theanine will be compared to that elicited by placebo within each subject."
10809122|NCT04749745|OG001|Outcome|Placebo|"Subject will receive 400mg single dose of matching Placebo, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.~The baseline-to-post-drug change of SICI, ICF and LICI elicited by L-theanine will be compared to that elicited by placebo within each subject."
10809123|NCT04749745|EG000|Reported Event|L-Theanine|Subject will receive 400mg single dose of L-theanine, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.
10809124|NCT04749745|EG001|Reported Event|Placebo|Subject will receive 400mg single dose of matching Placebo, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.
10809125|NCT04748341|BG000|Baseline|Traditional Group|"Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups.~Traditional Method: The traditional method group learns through 2-step method.~didactic lectures on neonatal resuscitation were delivered.~Practice skill on mannequins"
10809126|NCT04748341|BG001|Baseline|Pedagogical Group|"Group B will learn through the 5-step method [ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation.~Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The Learn, See, Practice, Prove, Do, and Maintain (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, Practice expose learners to perform the skill on a simulator. In the 4th step Prove the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th stepMaintain the learner maintains skill supplemented with simulation as needed."
10809127|NCT04748341|BG002|Baseline|Total|Total of all reporting groups
10809128|NCT04748341|FG000|Participant Flow|Traditional Group|"Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups.~Traditional Method: The traditional method group learns through 2-step method.~didactic lectures on neonatal resuscitation were delivered.~Practice skill on mannequins"
10821106|NCT00065260|FG000|Participant Flow|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
11205521|NCT02229461|FG005|Participant Flow|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205522|NCT02229461|OG000|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205523|NCT02229461|OG001|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205524|NCT02229461|OG002|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205525|NCT02229461|OG003|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205526|NCT02229461|OG004|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205527|NCT02229461|OG005|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11215415|NCT02299141|FG000|Participant Flow|Nintedanib|-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle
11215416|NCT02299141|OG000|Outcome|Nintedanib|-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle
10809129|NCT04748341|FG001|Participant Flow|Pedagogical Group|"Group B will learn through the 6-step method [ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation.~Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The Learn, See, Practice, Prove, Do, and Maintain (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, Practice expose learners to perform the skill on a simulator. In the 4th step Prove the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th stepMaintain the learner maintains skill supplemented with simulation as needed."
10809130|NCT04748341|OG000|Outcome|Traditional Group|"Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups.~Traditional Method: The traditional method group learns through 2-step method.~didactic lectures on neonatal resuscitation were delivered.~Practice skill on mannequins"
10809131|NCT04748341|OG001|Outcome|Pedagogical Group|"Group B will learn through the 6-step method [ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation.~Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The Learn, See, Practice, Prove, Do, and Maintain (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, Practice expose learners to perform the skill on a simulator. In the 4th step Prove the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th stepMaintain the learner maintains skill supplemented with simulation as needed."
10809132|NCT04748341|EG000|Reported Event|Traditional Group|"Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups.~Traditional Method: The traditional method group learns through 2-step method.~didactic lectures on neonatal resuscitation were delivered.~Practice skill on mannequins"
10809133|NCT04748341|EG001|Reported Event|Pedagogical Group|"Group B will learn through the 6-step method [ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation.~Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The Learn, See, Practice, Prove, Do, and Maintain (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, Practice expose learners to perform the skill on a simulator. In the 4th step Prove the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th stepMaintain the learner maintains skill supplemented with simulation as needed."
10821107|NCT00065260|FG001|Participant Flow|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
10821108|NCT00065260|OG000|Outcome|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
10821109|NCT00065260|OG001|Outcome|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
10821110|NCT00065260|EG000|Reported Event|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
10848180|NCT00288912|EG002|Reported Event|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
10809134|NCT04737278|BG000|Baseline|Cunermuspir|"Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.~Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:~Organic evaporated cane juice powder, hypromellose, titanium dioxide"
10809135|NCT04737278|BG001|Baseline|Placebo|"Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm~Placebo: same non-medical ingredients and encapsulation as Intervention 1"
10809136|NCT04737278|BG002|Baseline|Total|Total of all reporting groups
10809137|NCT04737278|FG000|Participant Flow|Cunermuspir|"Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.~Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:~Organic evaporated cane juice powder, hypromellose, titanium dioxide"
10809138|NCT04737278|FG001|Participant Flow|Placebo|"Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm~Placebo: same non-medical ingredients and encapsulation as Intervention 1"
10809139|NCT04737278|OG000|Outcome|Cunermuspir|"Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.~Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:~Organic evaporated cane juice powder, hypromellose, titanium dioxide"
10809140|NCT04737278|OG001|Outcome|Placebo|"Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm~Placebo: same non-medical ingredients and encapsulation as Intervention 1"
10809141|NCT04737278|EG000|Reported Event|Cunermuspir|"Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.~Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:~Organic evaporated cane juice powder, hypromellose, titanium dioxide"
10809142|NCT04737278|EG001|Reported Event|Placebo|"Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm~Placebo: same non-medical ingredients and encapsulation as Intervention 1"
10809158|NCT04600375|BG000|Baseline|Verbal Consultation, Then Written Action Plan|"CONTROL GROUP~Survey A~Routine clinic visit~Verbal consultation only~Survey B~Verbal consultation AND Written Action Plan~Survey C~Verbal consultation: Verbal consultation only without written information before receiving written action plan~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809159|NCT04600375|BG001|Baseline|Experimental: Written Action Plan|"INTERVENTION GROUP~Survey A~Routine clinic visit~Verbal consultation AND Written Action Plan~Survey C~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809160|NCT04600375|BG002|Baseline|Total|Total of all reporting groups
10809161|NCT04600375|FG000|Participant Flow|Verbal Consultation, Then Written Action Plan|"CONTROL GROUP~Survey A~Routine clinic visit~Verbal consultation only~Survey B~Verbal consultation AND Written Action Plan~Survey C~Verbal consultation: Verbal consultation only without written information before receiving written action plan~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809162|NCT04600375|FG001|Participant Flow|Experimental: Written Action Plan|"INTERVENTION GROUP~Survey A~Routine clinic visit~Verbal consultation AND Written Action Plan~Survey C~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809163|NCT04600375|OG000|Outcome|Verbal Consultation, Then Written Action Plan|"CONTROL GROUP~Survey A~Routine clinic visit~Verbal consultation only~Survey B~Verbal consultation AND Written Action Plan~Survey C~Verbal consultation: Verbal consultation only without written information before receiving written action plan~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809164|NCT04600375|OG001|Outcome|Experimental: Written Action Plan|"INTERVENTION GROUP~Survey A~Routine clinic visit~Verbal consultation AND Written Action Plan~Survey C~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809165|NCT04600375|EG000|Reported Event|Verbal Consultation, Then Written Action Plan|"CONTROL GROUP~Survey A~Routine clinic visit~Verbal consultation only~Survey B~Verbal consultation AND Written Action Plan~Survey C~Verbal consultation: Verbal consultation only without written information before receiving written action plan~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809166|NCT04600375|EG001|Reported Event|Experimental: Written Action Plan|"INTERVENTION GROUP~Survey A~Routine clinic visit~Verbal consultation AND Written Action Plan~Survey C~Written Action Plan: Written handout of treatment plan and disease management strategies"
10809167|NCT04524598|BG000|Baseline|Limbix Spark - Phase I|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809168|NCT04524598|BG001|Baseline|Psychoeducation - Phase I|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809169|NCT04524598|BG002|Baseline|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809170|NCT04524598|BG003|Baseline|Psychoeducation/Control Extension - Phase II|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.~Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809171|NCT04524598|BG004|Baseline|Total|Total of all reporting groups
10809143|NCT04736069|BG000|Baseline|Inpatient Physical Therapy|Group 1 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at inpatient clinic.
10809144|NCT04736069|BG001|Baseline|Outpatient Physical Therapy|Group 2 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at outpatient clinic.
10809145|NCT04736069|BG002|Baseline|Total|Total of all reporting groups
10809146|NCT04736069|FG000|Participant Flow|Inpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at inpatient clinic
10809147|NCT04736069|FG001|Participant Flow|Outpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at outpatient clinic
10809148|NCT04736069|OG000|Outcome|Inpatient Physical Therapy|"The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.~Physical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day."
10809149|NCT04736069|OG001|Outcome|Outpatient Physical Therapy|"The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.~Physical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day."
10809150|NCT04736069|OG000|Outcome|Inpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at inpatient clinic
10809151|NCT04736069|OG001|Outcome|Outpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at outpatient clinic
10809152|NCT04736069|OG000|Outcome|Inpatient Physical Therapy|"The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.~Physical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2); A combined range of motion and strengthening exercises/two times a day"
10809153|NCT04736069|OG001|Outcome|Outpatient Physical Therapy|"The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.~Physical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2); A combined range of motion and strengthening exercises:two times a day."
10809154|NCT04736069|OG000|Outcome|Inpatient Physical Therapy|"The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.~Physical therapy program:, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. A combined range of motion and strengthening exercises; two times a day."
10809155|NCT04736069|OG001|Outcome|Outpatient Physical Therapy|"The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.~Physical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. A combined range of motion and strengthening exercises; two times a day."
10809156|NCT04736069|EG000|Reported Event|Inpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at inpatient clinic
10809157|NCT04736069|EG001|Reported Event|Outpatient Physical Therapy|Patients who received physical therapy and rehabilitation program at outpatient clinic
10809172|NCT04524598|FG000|Participant Flow|Limbix Spark - Phase I|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809173|NCT04524598|FG001|Participant Flow|Psychoeducation - Phase I|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809174|NCT04524598|FG002|Participant Flow|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809175|NCT04524598|FG003|Participant Flow|Psychoeducation - Phase II|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809176|NCT04524598|FG004|Participant Flow|Control Extension - Phase II|"Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809177|NCT04524598|OG000|Outcome|Number of Potentially Eligible Participants|The number of participants who expressed interest in participating in the study
10809178|NCT04524598|OG000|Outcome|Limbix Spark - Phase I|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
11215417|NCT02299141|OG000|Outcome|Responder A|-Includes the mutations associated with Responder A
11215418|NCT02299141|OG001|Outcome|Responder B|-Includes the mutations associated with Responder B
11215419|NCT02299141|OG002|Outcome|Responder C|-Includes the mutations associated with Responder C
11215420|NCT02299141|OG003|Outcome|Progressive Disease A|-Includes the mutations associated with participant Progressive Disease A
10809179|NCT04524598|OG001|Outcome|Psychoeducation - Phase I|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809180|NCT04524598|OG000|Outcome|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809181|NCT04524598|OG001|Outcome|Psychoeducation - Phase II|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809182|NCT04524598|OG002|Outcome|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809183|NCT04524598|OG003|Outcome|Psychoeducation/Control Extension - Phase II|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.~Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809184|NCT04524598|OG001|Outcome|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809185|NCT04524598|EG000|Reported Event|Limbix Spark - Phase I|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809186|NCT04524598|EG001|Reported Event|Psychoeducation - Phase I|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809187|NCT04524598|EG002|Reported Event|Limbix Spark - Phase II|"A 5 week CBT-based intervention~Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities."
10809188|NCT04524598|EG003|Reported Event|Psychoeducation - Phase II|"5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention~Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression."
10809189|NCT04334460|BG000|Baseline|Active Group|BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
10809190|NCT04334460|BG001|Baseline|Placebo Group|Placebo to Match (PTM) the active BLD-2660
10809191|NCT04334460|BG002|Baseline|Total|Total of all reporting groups
10809192|NCT04334460|FG000|Participant Flow|Active Group|BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
10809193|NCT04334460|FG001|Participant Flow|Placebo Group|Placebo: Placebo-to-Match BLD-2660
10809194|NCT04334460|OG000|Outcome|Active Group|BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
10809195|NCT04334460|OG001|Outcome|Placebo Group|Placebo: Placebo-to-Match BLD-2660
10809196|NCT04334460|OG001|Outcome|Placebo Group|Placebo to Match (PTM) the active BLD-2660
10809197|NCT04334460|EG000|Reported Event|Active Group|BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
10809198|NCT04334460|EG001|Reported Event|Placebo Group|Placebo to Match (PTM) the active BLD-2660
10821111|NCT00065260|EG001|Reported Event|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
10821112|NCT00065429|BG000|Baseline|IMGN 5 mg/m2|Arm 1, Phase 1
10821113|NCT00065429|BG001|Baseline|IMGN 10 mg/m2|Arm 2, Phase 1
10821114|NCT00065429|BG002|Baseline|IMGN 20 mg/m2|Arm 3, Phase 1
10821115|NCT00065429|BG003|Baseline|IMGN 40 mg/m2|Arm 4, Phase 1
10821116|NCT00065429|BG004|Baseline|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
10821117|NCT00065429|BG005|Baseline|IMGN 67.5 mg/m2|Arm 6, Phase 1
10821118|NCT00065429|BG006|Baseline|IMGN 75 mg/m2|Arm 7, Phase 1
10821119|NCT00065429|BG007|Baseline|Total|Total of all reporting groups
10821120|NCT00065429|FG000|Participant Flow|IMGN 5 mg/m2|Arm 1, Phase 1
10821121|NCT00065429|FG001|Participant Flow|IMGN 10 mg/m2|Arm 2, Phase 1
10821122|NCT00065429|FG002|Participant Flow|IMGN 20 mg/m2|Arm 3, Phase 1
10821123|NCT00065429|FG003|Participant Flow|IMGN 40 mg/m2|Arm 4, Phase 1
10821124|NCT00065429|FG004|Participant Flow|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
10821125|NCT00065429|FG005|Participant Flow|IMGN 67.5 mg/m2|Arm 6, Phase 1
10821126|NCT00065429|FG006|Participant Flow|IMGN 75 mg/m2|Arm 7, Phase 1
11215421|NCT02299141|OG004|Outcome|Progressive Disease B|-Includes the mutations associated with participant Progressive Disease B
11215422|NCT02299141|OG005|Outcome|Progressive Disease C|-Includes the mutations associated with participant Progressive Disease C
11215423|NCT02299141|OG006|Outcome|Progressive Disease D|-Includes the mutations associated with participant Progressive Disease D
11215424|NCT02299141|EG000|Reported Event|Nintedanib|-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle
10809199|NCT04247828|BG000|Baseline|Experimental and Generic Communication Interfaces for AAC|"Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).~Experimental AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.~Generic AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance."
10809200|NCT04247828|FG000|Participant Flow|Experimental and Generic Communication Interfaces for AAC|"Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).~Experimental AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.~Generic AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance."
10809201|NCT04247828|OG000|Outcome|Experimental and Generic Communication Interfaces for AAC|"Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).~Experimental AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.~Generic AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance."
10809202|NCT04247828|EG000|Reported Event|Experimental and Generic Communication Interfaces for AAC|"Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).~Experimental AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.~Generic AAC: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance."
10809203|NCT04084769|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809204|NCT04084769|BG001|Baseline|Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)|Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809205|NCT04084769|BG002|Baseline|Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
10809206|NCT04084769|BG003|Baseline|Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
10809207|NCT04084769|BG004|Baseline|Total|Total of all reporting groups
10809208|NCT04084769|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809209|NCT04084769|FG001|Participant Flow|Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)|Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809210|NCT04084769|FG002|Participant Flow|Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
10809211|NCT04084769|FG003|Participant Flow|Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
10809212|NCT04084769|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809213|NCT04084769|OG000|Outcome|Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)|Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809214|NCT04084769|OG001|Outcome|Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)|Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809215|NCT04084769|OG002|Outcome|Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
10809216|NCT04084769|OG003|Outcome|Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
11205528|NCT02229461|EG000|Reported Event|Group 0-IR ASA 81 mg qd in Run-in Period|Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
11205529|NCT02229461|EG001|Reported Event|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205530|NCT02229461|EG002|Reported Event|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205531|NCT02229461|EG003|Reported Event|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205532|NCT02229461|EG004|Reported Event|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
11205533|NCT02229461|EG005|Reported Event|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
10809217|NCT04084769|OG000|Outcome|Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine|Included all participants of Groups 1, 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 1 participants received a single IM dose of MenACYW Conjugate vaccine and Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine, respectively, at Day 0 in the present study (MET59).
10809218|NCT04084769|OG001|Outcome|Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
10809219|NCT04084769|OG002|Outcome|Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
11205534|NCT02229461|EG006|Reported Event|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
10809220|NCT04084769|OG003|Outcome|Pooled Groups 3 and 4: MenACYW Conjugate Vaccine|Included all participants of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).
10809221|NCT04084769|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809222|NCT04084769|EG001|Reported Event|Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)|Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
10809223|NCT04084769|EG002|Reported Event|Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
10809224|NCT04084769|EG003|Reported Event|Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine|Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
10809225|NCT04024228|BG000|Baseline|Group 1: QIV-HD|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
10809226|NCT04024228|BG001|Baseline|Group 2: QIV-SD|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
11205535|NCT02229474|BG000|Baseline|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve outcomes"
11205536|NCT02229474|BG001|Baseline|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
11205537|NCT02229474|BG002|Baseline|Total|Total of all reporting groups
10809227|NCT04024228|BG002|Baseline|Total|Total of all reporting groups
10809228|NCT04024228|FG000|Participant Flow|Group 1: QIV-HD|Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
10809229|NCT04024228|FG001|Participant Flow|Group 2: QIV-SD|Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
10809230|NCT04024228|OG000|Outcome|Group 1: QIV-HD|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
10809231|NCT04024228|OG001|Outcome|Group 2: QIV-SD|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
10809232|NCT04024228|OG001|Outcome|Group 2: QIV-SD|Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
10809233|NCT04024228|OG000|Outcome|Group 1: QIV-HD|Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
10809234|NCT04024228|EG000|Reported Event|Group 1 QIV-HD|Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
10809235|NCT04024228|EG001|Reported Event|Group 2 QIV-SD|Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
10809236|NCT03996148|BG000|Baseline|Remifentanil, Propofol, and Desflurane|"Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC"
10809237|NCT03996148|BG001|Baseline|Remifentanil, Dexmedetomidine, and Desflurane|"Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC"
10809238|NCT03996148|BG002|Baseline|Remifentanil and Desflurane|"Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable"
10809239|NCT03996148|BG003|Baseline|Total|Total of all reporting groups
10809240|NCT03996148|FG000|Participant Flow|Remifentanil, Propofol, and Desflurane|"Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC"
10809241|NCT03996148|FG001|Participant Flow|Remifentanil, Dexmedetomidine, and Desflurane|"Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC"
10809242|NCT03996148|FG002|Participant Flow|Remifentanil and Desflurane|"Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable"
10809243|NCT03996148|OG000|Outcome|Remifentanil, Propofol, and Desflurane|"Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC"
10809244|NCT03996148|OG001|Outcome|Remifentanil, Dexmedetomidine, and Desflurane|"Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC"
10809245|NCT03996148|OG002|Outcome|Remifentanil and Desflurane|"Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable"
10809246|NCT03996148|EG000|Reported Event|Remifentanil, Propofol, and Desflurane|"Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC"
10809247|NCT03996148|EG001|Reported Event|Remifentanil, Dexmedetomidine, and Desflurane|"Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC"
10809248|NCT03996148|EG002|Reported Event|Remifentanil and Desflurane|"Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.~Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable"
10809249|NCT03980938|BG000|Baseline|Neflamapimod First|"neflamapimod in Treatment Period 1, placebo in Treatment Period 2~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food.~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food."
10809250|NCT03980938|BG001|Baseline|Placebo First|"placebo in Treatment Period 1, neflamapimod in Treatment Period 2~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food."
10809251|NCT03980938|BG002|Baseline|Total|Total of all reporting groups
10809252|NCT03980938|FG000|Participant Flow|Neflamapimod First|"neflamapimod in Treatment Period 1, placebo in Treatment Period 2~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food.~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food."
10809253|NCT03980938|FG001|Participant Flow|Placebo First|"placebo in Treatment Period 1, neflamapimod in Treatment Period 2~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food."
10809254|NCT03980938|OG000|Outcome|Neflamapimod First|"neflamapimod in Treatment Period 1, placebo in Treatment Period 2~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food.~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food."
10809255|NCT03980938|OG001|Outcome|Placebo First|"placebo in Treatment Period 1, neflamapimod in Treatment Period 2~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food."
10809256|NCT03980938|EG000|Reported Event|Neflamapimod First|"neflamapimod in Treatment Period 1, placebo in Treatment Period 2~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food.~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food."
10809257|NCT03980938|EG001|Reported Event|Placebo First|"placebo in Treatment Period 1, neflamapimod in Treatment Period 2~Placebo: hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food.~neflamapimod: 40 mg neflamapimod hard gelatin capsules, taken twice daily with food."
10821127|NCT00065429|OG000|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
10821128|NCT00065429|OG001|Outcome|Phase II|For Phase II, the planned design was to use a Gehan's two-stage design [4], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
10821129|NCT00065429|EG000|Reported Event|IMGN 5 mg/m2|Arm 1, Phase 1
10821130|NCT00065429|EG001|Reported Event|IMGN 10 mg/m2|Arm 2, Phase 1
10821131|NCT00065429|EG002|Reported Event|IMGN 20 mg/m2|Arm 3, Phase 1
10821132|NCT00065429|EG003|Reported Event|IMGN 40 mg/m2|Arm 4, Phase 1
10821133|NCT00065429|EG004|Reported Event|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
10821134|NCT00065429|EG005|Reported Event|IMGN 67.5 mg/m2|Arm 6, Phase 1
10821135|NCT00065429|EG006|Reported Event|IMGN 75 mg/m2|Arm 7, Phase 1
10821136|NCT00065442|BG000|Baseline|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
10821137|NCT00065442|BG001|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
10821138|NCT00065442|BG002|Baseline|Total|Total of all reporting groups
10821139|NCT00065442|FG000|Participant Flow|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
10821140|NCT00065442|FG001|Participant Flow|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
10821141|NCT00065442|OG000|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
10821142|NCT00065442|OG001|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
10821143|NCT00065442|EG000|Reported Event|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
10821144|NCT00065442|EG001|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
10821145|NCT00065468|BG000|Baseline|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
10821146|NCT00065468|BG001|Baseline|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
10821147|NCT00065468|BG002|Baseline|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
10821148|NCT00065468|BG003|Baseline|Total|Total of all reporting groups
10821149|NCT00065468|FG000|Participant Flow|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
10821150|NCT00065468|FG001|Participant Flow|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
10821151|NCT00065468|FG002|Participant Flow|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
10809258|NCT03863353|BG000|Baseline|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
10809259|NCT03863353|BG001|Baseline|Control|This group will receive only standard of care information.
10809260|NCT03863353|BG002|Baseline|Total|Total of all reporting groups
10809261|NCT03863353|FG000|Participant Flow|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
10809262|NCT03863353|FG001|Participant Flow|Control|This group will receive only standard of care information.
10809263|NCT03863353|OG000|Outcome|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
10809264|NCT03863353|OG001|Outcome|Control|This group will receive only standard of care information.
10809265|NCT03863353|EG000|Reported Event|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
10809266|NCT03863353|EG001|Reported Event|Control|This group will receive only standard of care information.
10809267|NCT03622593|BG000|Baseline|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809268|NCT03622593|BG001|Baseline|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809269|NCT03622593|BG002|Baseline|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809270|NCT03622593|BG003|Baseline|Total|Total of all reporting groups
10809271|NCT03622593|FG000|Participant Flow|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809272|NCT03622593|FG001|Participant Flow|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809273|NCT03622593|FG002|Participant Flow|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809274|NCT03622593|OG000|Outcome|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809275|NCT03622593|OG001|Outcome|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809276|NCT03622593|OG002|Outcome|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809277|NCT03622593|OG000|Outcome|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809278|NCT03622593|EG000|Reported Event|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
11286167|NCT02885012|BG000|Baseline|Switch to Letairis From Bosentan|"Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809279|NCT03622593|EG001|Reported Event|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809280|NCT03622593|EG002|Reported Event|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809281|NCT03622580|BG000|Baseline|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809282|NCT03622580|BG001|Baseline|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809283|NCT03622580|BG002|Baseline|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809284|NCT03622580|BG003|Baseline|Total|Total of all reporting groups
10809285|NCT03622580|FG000|Participant Flow|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809286|NCT03622580|FG001|Participant Flow|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809287|NCT03622580|FG002|Participant Flow|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809288|NCT03622580|OG000|Outcome|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809289|NCT03622580|OG001|Outcome|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809290|NCT03622580|OG002|Outcome|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809291|NCT03622580|OG000|Outcome|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809292|NCT03622580|EG000|Reported Event|A: Faricimab 6 mg Q8W|Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
10809293|NCT03622580|EG001|Reported Event|B: Faricimab 6 mg PTI|Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
10809294|NCT03622580|EG002|Reported Event|C: Aflibercept 2 mg Q8W|Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
10809295|NCT03572634|BG000|Baseline|TP-0903 Monotherapy (25mg Dose of TP-0903)|Patients who are intolerant to, or have had progressive disease on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments. This represents phase I, phase II never occurred and dose escalation did not occur.
10809296|NCT03572634|BG001|Baseline|TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903)|Patients with CLL/SLL who had progressed on ibrutinib, yet the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur.
10809297|NCT03572634|BG002|Baseline|Total|Total of all reporting groups
10809298|NCT03572634|FG000|Participant Flow|TP-0903 Monotherapy (25mg Dose of TP-0903)|Patients who are intolerant to, or have had progressive disease on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments. This represents phase I, phase II never occurred and dose escalation did not occur.
10809299|NCT03572634|FG001|Participant Flow|TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903)|Patients who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur.
11244297|NCT02509936|OG001|Outcome|Home-based Education|"In the intervention arm, children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they received monthly home visits from a community health promoter who provided detailed dietary assessments and individualized dietary coaching and education to parents.~Home-based nutrition education: Health promoters used 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10809300|NCT03572634|OG000|Outcome|TP-0903 Monotherapy (25mg Dose of TP-0903)|Patients who are intolerant to, or have had progressive disease on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments. This represents phase I, phase II never occurred and dose escalation did not occur.
10809301|NCT03572634|OG001|Outcome|TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903)|Patients with CLL/SLL who had progressed on ibrutinib, yet the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur.
10809302|NCT03572634|OG001|Outcome|TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903)|Patients who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur.
10809303|NCT03572634|EG000|Reported Event|TP-0903 Monotherapy (25mg Dose of TP-0903)|Patients who are intolerant to, or have had progressive disease on B-cell receptor antagonists and/or BCL-2 antagonists or other investigational treatments. This represents phase I, phase II never occurred and dose escalation did not occur.
10809304|NCT03572634|EG001|Reported Event|TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903)|Patients who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient. This represents phase I, phase II never occurred and dose escalation did not occur.
10809305|NCT03562156|BG000|Baseline|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809306|NCT03562156|BG001|Baseline|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809307|NCT03562156|BG002|Baseline|Total|Total of all reporting groups
10809308|NCT03562156|FG000|Participant Flow|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809309|NCT03562156|FG001|Participant Flow|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809310|NCT03562156|OG000|Outcome|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809311|NCT03562156|OG001|Outcome|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809312|NCT03562156|EG000|Reported Event|Oteseconazole (VT-1161)|1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809313|NCT03562156|EG001|Reported Event|Placebo|1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
10809314|NCT03476135|BG000|Baseline|Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)|Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809315|NCT03476135|BG001|Baseline|Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)|Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809316|NCT03476135|BG002|Baseline|Total|Total of all reporting groups
10809317|NCT03476135|FG000|Participant Flow|Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)|Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809318|NCT03476135|FG001|Participant Flow|Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)|Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809319|NCT03476135|OG000|Outcome|Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)|Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809320|NCT03476135|OG001|Outcome|Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)|Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809321|NCT03476135|EG000|Reported Event|Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)|Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10809322|NCT03476135|EG001|Reported Event|Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)|Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
10821152|NCT00065468|OG000|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
10821153|NCT00065468|OG001|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
10821154|NCT00065468|OG002|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
10821155|NCT00065468|EG000|Reported Event|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
10821156|NCT00065468|EG001|Reported Event|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
10821157|NCT00065468|EG002|Reported Event|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
10821158|NCT00065507|BG000|Baseline|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
10821159|NCT00065507|BG001|Baseline|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
10821160|NCT00065507|BG002|Baseline|Total|Total of all reporting groups
10821161|NCT00065507|FG000|Participant Flow|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
10821162|NCT00065507|FG001|Participant Flow|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
10821163|NCT00065507|OG000|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
10821164|NCT00065507|OG001|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
10821165|NCT00065507|OG000|Outcome|Week 48 - Entecavir (ETV) 1.0 mg|
10821166|NCT00065507|OG001|Outcome|Week 48 - Adefovir (ADV) 10 mg|
10821167|NCT00065507|OG002|Outcome|Cumulative - Entecavir (ETV) 1.0 mg|
10821168|NCT00065507|OG003|Outcome|Cumulative - Adefovir (ADV) 10 mg|
10821169|NCT00065507|EG000|Reported Event|ADEFOVIR|
10821170|NCT00065507|EG001|Reported Event|ENTECAVIR|
10821171|NCT00065611|BG000|Baseline|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
10821172|NCT00065611|BG001|Baseline|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
10821173|NCT00065611|BG002|Baseline|Total|Total of all reporting groups
10809323|NCT03333928|BG000|Baseline|HTD1801 500 mg BID|HTD1801: HTD1801 tablets, 250mg
10809324|NCT03333928|BG001|Baseline|HTD1801 1000 mg BID|HTD1801: HTD1801 tablets, 250mg
10809325|NCT03333928|BG002|Baseline|Placebo BID|Placebo: tablets manufactured to mimic HTD1801 tablets
10809326|NCT03333928|BG003|Baseline|Total|Total of all reporting groups
10809327|NCT03333928|FG000|Participant Flow|500mg HTD1801 BID|HTD1801: HTD1801 tablets, 250 mg
10809328|NCT03333928|FG001|Participant Flow|1000 mg HTD1801 BID|HTD1801: HTD1801 tablets, 250 mg
10809329|NCT03333928|FG002|Participant Flow|Placebo BID|Placebo: tablets manufactured to mimic HTD1801 tablets
10809330|NCT03333928|OG000|Outcome|HTD1801 500 mg BID|HTD1801: HTD1801 tablets, 250 mg
10809331|NCT03333928|OG001|Outcome|HTD1801 1000 mg BID|HTD1801: HTD1801 tablets, 250 mg
10809332|NCT03333928|OG002|Outcome|Placebo BID|Placebo: tablets manufactured to mimic HTD1801 tablets
10809333|NCT03333928|OG000|Outcome|Placebo to HTD1801 500 mg BID|Subjects randomized to receive Placebo BID in Period 1 re-randomized to receive HTD1801 500 mg BID in Period 2
10809334|NCT03333928|OG001|Outcome|HTD1801 500 mg BID to HTD1801 500 mg BID|Subjects randomized to receive HTD1801 500 mg BID in Period 1 continuing to receive HTD1801 500 mg BID in Period 2
10809335|NCT03333928|OG002|Outcome|Placebo to HTD1801 1000 mg BID|Subjects randomized to receive Placebo BID in Period 1 re-randomized to receive HTD1801 1000 mg BID in Period 2
10809336|NCT03333928|OG003|Outcome|HTD1801 1000 mg BID to HTD1801 1000 mg BID|Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
10809337|NCT03333928|OG000|Outcome|HTD1801 500 mg BID to HTD1801 500 mg BID|Subjects who received 500 mg HTD1801 BID in Period 2 re-randomized to continue receiving HTD1801 500 mg BID in Period 3.
10809338|NCT03333928|OG001|Outcome|HTD1801 1000 mg BID to HTD1801 1000 mg BID|Subjects who received 1000 mg HTD1801 BID in Period 2 re-randomized to continue receiving HTD1801 1000 mg BID in Period 3.
10809339|NCT03333928|OG002|Outcome|HTD1801 500 mg BID to Placebo|Subjects who received 500 mg HTD1801 BID in Period 2 re-randomized to receive Placebo in Period 3.
10809340|NCT03333928|OG003|Outcome|HTD1801 1000 mg BID to Placebo|Subjects who received 1000 mg HTD1801 BID in Period 2 re-randomized to receive Placebo in Period 3.
10809341|NCT03333928|EG000|Reported Event|500mg HTD1801 Bid|HTD1801: HTD1801 tablets, 250mg
10809342|NCT03333928|EG001|Reported Event|1000mg HTD1801 Bid|HTD1801: HTD1801 tablets, 250mg
10809343|NCT03333928|EG002|Reported Event|Placebo Bid|Placebo: tablets manufactured to mimic HTD1801 tablets
10809344|NCT03298984|BG000|Baseline|Alvocidib 20/30 mg/m2|Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours
10809345|NCT03298984|BG001|Baseline|Alvocidib 30/40 mg/m2|Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours
10809346|NCT03298984|BG002|Baseline|Alvocidib 30/50 mg/m2|Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours
10809347|NCT03298984|BG003|Baseline|Alvocidib 30/60 mg/m2|Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
10809348|NCT03298984|BG004|Baseline|Total|Total of all reporting groups
10809349|NCT03298984|FG000|Participant Flow|Alvocidib 20/30 mg/m2|Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours
10809350|NCT03298984|FG001|Participant Flow|Alvocidib 30/40 mg/m2|Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours
10809351|NCT03298984|FG002|Participant Flow|Alvocidib 30/50 mg/m2|Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours
10809352|NCT03298984|FG003|Participant Flow|Alvocidib 30/60 mg/m2|Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
10809353|NCT03298984|OG000|Outcome|All Participants|All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
10809354|NCT03298984|OG000|Outcome|Alvocidib 20/30 mg/m2|Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours
10809355|NCT03298984|OG001|Outcome|Alvocidib 30/40 mg/m2|Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours
10809356|NCT03298984|OG002|Outcome|Alvocidib 30/50 mg/m2|Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours
10809357|NCT03298984|OG003|Outcome|Alvocidib 30/60 mg/m2|Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
10809358|NCT03298984|EG000|Reported Event|Alvocidib 20/30 mg/m2 (N=3)|Alvocidib 20mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours
10809359|NCT03298984|EG001|Reported Event|Alvocidib 30/40 mg/m2 (N=3)|Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours
10809360|NCT03298984|EG002|Reported Event|Alvocidib 30/50 mg/m2 (N=3)|Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours
10809361|NCT03298984|EG003|Reported Event|Alvocidib 30/60 mg/m2 (N=23)|Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
10809362|NCT03175198|BG000|Baseline|Patients With Nonvalvular Atrial Fibrillation (NVAF)|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
10809363|NCT03175198|FG000|Participant Flow|Patients With Nonvalvular Atrial Fibrillation (NVAF)|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
10809364|NCT03175198|OG000|Outcome|Patients With Nonvalvular Atrial Fibrillation (NVAF)|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
10821174|NCT00065611|FG000|Participant Flow|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
10821175|NCT00065611|FG001|Participant Flow|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
10809365|NCT03175198|EG000|Reported Event|Patients With Nonvalvular Atrial Fibrillation (NVAF)|Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
10809366|NCT03158727|BG000|Baseline|Placebo|Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3.
10809367|NCT03158727|BG001|Baseline|Cx611 160 mL|Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total).
10809368|NCT03158727|BG002|Baseline|Total|Total of all reporting groups
10809369|NCT03158727|FG000|Participant Flow|Placebo|Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3.
10809370|NCT03158727|FG001|Participant Flow|Cx611 160 mL|Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total).
10809371|NCT03158727|OG000|Outcome|Placebo|Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3.
10809372|NCT03158727|OG001|Outcome|Cx611 160 mL|Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total).
10809373|NCT03158727|EG000|Reported Event|Placebo|Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3.
10809374|NCT03158727|EG001|Reported Event|Cx611 160 mL|Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total).
10809375|NCT03075826|BG000|Baseline|Open Label-Single Arm|"This is a single arm, open-label study of SGI-110 in patients with MPN. SGI-110 will be administered subcutaneously at a dose of 60 mg/m2 on days 1-5, repeated every 28 days. Toxicity will be evaluated using the NCI Common Terminology Criteria for Adverse Events Active Version 4. The frequency of toxicities per organ system will be tabulated using descriptive statistics. All patients who receive any amount of the study drug will be evaluable for toxicity~SGI-110: subcutaneously at a dose of 60 mg/m2"
10809376|NCT03075826|FG000|Participant Flow|Open Label-Single Arm|"This is a single arm, open-label study of SGI-110 in patients with MPN. SGI-110 will be administered subcutaneously at a dose of 60 mg/m2 on days 1-5, repeated every 28 days. Toxicity will be evaluated using the NCI Common Terminology Criteria for Adverse Events Active Version 4. The frequency of toxicities per organ system will be tabulated using descriptive statistics. All patients who receive any amount of the study drug will be evaluable for toxicity~SGI-110: subcutaneously at a dose of 60 mg/m2"
10809377|NCT03075826|OG000|Outcome|Open Label-Single Arm|"This is a single arm, open-label study of SGI-110 in patients with MPN. SGI-110 will be administered subcutaneously at a dose of 60 mg/m2 on days 1-5, repeated every 28 days. Toxicity will be evaluated using the NCI Common Terminology Criteria for Adverse Events Active Version 4. The frequency of toxicities per organ system will be tabulated using descriptive statistics. All patients who receive any amount of the study drug will be evaluable for toxicity~SGI-110: subcutaneously at a dose of 60 mg/m2"
10809378|NCT03075826|EG000|Reported Event|Open Label-Single Arm|"This is a single arm, open-label study of SGI-110 in patients with MPN. SGI-110 will be administered subcutaneously at a dose of 60 mg/m2 on days 1-5, repeated every 28 days. Toxicity will be evaluated using the NCI Common Terminology Criteria for Adverse Events Active Version 4. The frequency of toxicities per organ system will be tabulated using descriptive statistics. All patients who receive any amount of the study drug will be evaluable for toxicity~SGI-110: subcutaneously at a dose of 60 mg/m2"
10809379|NCT02993731|BG000|Baseline|Napabucasin Plus Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809380|NCT02993731|BG001|Baseline|Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809381|NCT02993731|BG002|Baseline|Total|Total of all reporting groups
10809382|NCT02993731|FG000|Participant Flow|Napabucasin Plus Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809383|NCT02993731|FG001|Participant Flow|Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809384|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809385|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809386|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine (Response Analysis Set)|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.
10809387|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine (Response Analysis Set)|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.
10809388|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population)|All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10821176|NCT00065611|OG000|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
10809389|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine (Safety Population)|All participants who received at least 1 dose of nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809390|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, and had at least one valid assessment at each analysis window.
10809391|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, and had at least one valid assessment at each analysis window.
10809392|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.
10809393|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.
10809394|NCT02993731|OG000|Outcome|Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)|All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.
10809395|NCT02993731|OG001|Outcome|Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)|All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.
10809396|NCT02993731|EG000|Reported Event|Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population)|All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809397|NCT02993731|EG001|Reported Event|Nab-paclitaxel With Gemcitabine (Safety Population)|All participants who received at least 1 dose of nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
10809398|NCT02826161|BG000|Baseline|Napabucasin Plus Paclitaxel|All participants randomized to receive napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; once weekly ( three out of every four weeks)
10809399|NCT02826161|BG001|Baseline|Paclitaxel Only|All participants randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks)
10809400|NCT02826161|BG002|Baseline|Total|Total of all reporting groups
10809401|NCT02826161|FG000|Participant Flow|Napabucasin Plus Paclitaxel|All participants were randomized to receive napabucasin (BBI-608) 240 mg administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; once weekly ( three out of every four weeks)
10809402|NCT02826161|FG001|Participant Flow|Paclitaxel Only|All participants were randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks)
10809403|NCT02826161|OG000|Outcome|All Participants|All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
10809404|NCT02826161|EG000|Reported Event|Napabucasin+Paclitaxel|All participants part of the safety population ( those who received at least 1 dose of study drug napabucasin).
10809405|NCT02826161|EG001|Reported Event|Paclitaxel Only|All participants part of the safety population ( those who received at least 1 dose of paclitaxel).
10809406|NCT02586025|BG000|Baseline|Pertuzumab, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) for 3 cycles (1 cycle = 21 days): trastuzumab and pertuzumab for up to 13 cycles (1 cycle = 21 days).
10809407|NCT02586025|BG001|Baseline|Placebo, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy for 3 cycles (1 cycle = 21 days): trastuzumab and placebo for up to 13 cycles (1 cycle =21 days).
10809408|NCT02586025|BG002|Baseline|Total|Total of all reporting groups
10809409|NCT02586025|FG000|Participant Flow|Pertuzumab, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) for 3 cycles (1 cycle = 21 days): trastuzumab and pertuzumab for up to 13 cycles (1 cycle = 21 days).
10809410|NCT02586025|FG001|Participant Flow|Placebo, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy for 3 cycles (1 cycle = 21 days): trastuzumab and placebo for up to 13 cycles (1 cycle =21 days).
10809411|NCT02586025|OG000|Outcome|Pertuzumab, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) for 3 cycles (1 cycle = 21 days): trastuzumab and pertuzumab for up to 13 cycles (1 cycle = 21 days).
10809412|NCT02586025|OG001|Outcome|Placebo, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy for 3 cycles (1 cycle = 21 days): trastuzumab and placebo for up to 13 cycles (1 cycle =21 days).
10809413|NCT02586025|EG000|Reported Event|Pertuzumab, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) for 3 cycles (1 cycle = 21 days): trastuzumab and pertuzumab for up to 13 cycles (1 cycle = 21 days).
10809414|NCT02586025|EG001|Reported Event|Placebo, Trastuzumab, Docetaxel|Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy for 3 cycles (1 cycle = 21 days): trastuzumab and placebo for up to 13 cycles (1 cycle =21 days).
10809415|NCT02520011|BG000|Baseline|CM Relapsed/Refractory|Stage 2 Relapsed/Refractory AML patients who were randomized to receive CM
10809416|NCT02520011|BG001|Baseline|ACM Relapsed/Refractory|Relapsed/Refractory AML patients enrolled to Stage 1 and those enrolled to Stage 2 who received ACM.
10809417|NCT02520011|BG002|Baseline|ACM Newly Diagnosed|Newly diagnosed AML patients enrolled and received ACM.
10809418|NCT02520011|BG003|Baseline|Total|Total of all reporting groups
10809419|NCT02520011|FG000|Participant Flow|CM Relapsed/Refractory|Patients who were relapsed/refractory AML and were enrolled during Stage 2 and received Cytarabine 2 gm/m2 by continuous infusion over 72 hours on Days 1-3 and Mitoxantrone 40 mg/m2 by IV over 1-2 hours starting 12 hours after completing cytarabine.
10809420|NCT02520011|FG001|Participant Flow|ACM Relapsed/Refractory|Patients who had relapsed/refractory AML and were enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
10809421|NCT02520011|FG002|Participant Flow|ACM Newly Diagnosed|Patients who were newly diagnosed AML and enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
10809422|NCT02520011|OG000|Outcome|Stage 2 CM Relapsed/Refractory|Stage 2 Relapsed/Refractory AML patients who were randomized to receive CM
10809423|NCT02520011|OG001|Outcome|Stage 2 ACM Relapsed/Refractory|Stage 2 Relapsed/Refractory AML patients who were randomized to receive ACM
11205538|NCT02229474|FG000|Participant Flow|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall."
10809424|NCT02520011|OG002|Outcome|Stage 1 ACM Relapsed/Refractory|Stage 1 Relapsed/Refractory AML patients received ACM
10809425|NCT02520011|OG003|Outcome|Stages 1 and 2 ACM Relapsed/Refractory|Stages 1 and 2 Relapsed/Refractory AML patients combined who received ACM
11205539|NCT02229474|FG001|Participant Flow|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
10809426|NCT02520011|OG004|Outcome|Stage 1 Newly Diagnosed ACM|Stage 1 Newly Diagnosed AML patients who received ACM
10809427|NCT02520011|OG005|Outcome|All Stages and Cohorts (Including Randomized Stage): ACM Total|"Total patients who received ACM (Stages 1 and 2 Relapsed/Refractory AML patients and Newly Diagnosed patients combined)"
11215425|NCT02299167|BG000|Baseline|Saddle Block|"The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method~Dixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."
10809428|NCT02520011|OG000|Outcome|Stage 2 CM Relapsed/Refractory AML|A total 11 patients were initially randomized to the CM arm. 6 had CR from receiving CM so they did not cross over to receive ACM. Of the remaining 5 patients, only 2 crossed over to receive ACM and were included in the analysis of this outcome.
10809429|NCT02520011|EG000|Reported Event|CM Relapsed/Refractory|CM Relapse/Refractory patients who received at least 1 dose of study drug
10809430|NCT02520011|EG001|Reported Event|ACM Relapsed/Refractory|ACM Relapsed/Refractory patients who received at least 1 dose of study drug
10809431|NCT02520011|EG002|Reported Event|ACM Newly Diagnosed|ACM Newly Diagnosed patients who received at least 1 dose of study drug
10809432|NCT02520011|EG003|Reported Event|ACM Total|ACM Total patients who received at least 1 dose of study drug
10809433|NCT02315534|BG000|Baseline|Candidates Whom Surgery is Recommended.|Candidates who were candidates for repeat surgical resection
10809434|NCT02315534|BG001|Baseline|Candidates Whom Surgery is Not Recommended|Candidates who were not candidates for repeat surgical resection
10809435|NCT02315534|BG002|Baseline|Total|Total of all reporting groups
10809436|NCT02315534|FG000|Participant Flow|Candidates Whom Surgery is Recommended.|BBI608 will be administered at the recommended phase 2 dose (RP2D) twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide
10809437|NCT02315534|FG001|Participant Flow|Candidates Whom Surgery is Not Recommended.|Patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the recommended phase 2 dose (RP2D) in combination with temozolomide
10809438|NCT02315534|OG000|Outcome|Candidates Whom Surgery is Recommended.|The first 6 patients whom surgery was recommended that received 28 days of continuous daily administration of BBI608 in combination with TMZ. Patients also had to be ≥ 80% compliant to assigned dose to qualify for DLT analysis.
10809439|NCT02315534|OG001|Outcome|Candidates Whom Surgery is Not Recommended|The first 6 patients whom surgery was not recommended that received 28 days of continuous daily administration of BBI608 in combination with TMZ. Patients also had to be ≥ 80% compliant to assigned dose to qualify for DLT analysis.
10821177|NCT00065611|OG001|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
10809440|NCT02315534|OG000|Outcome|Candidates Whom Surgery is Not Recommended.|Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.
10809441|NCT02315534|OG001|Outcome|Candidates Whom Surgery is Recommended.|Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.
10809442|NCT02315534|OG000|Outcome|Candidates Whom Surgery is Not Recommended|Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.
10809443|NCT02315534|OG001|Outcome|Candidates Whom Surgery is Recommended|Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.
10809444|NCT02315534|OG000|Outcome|Candidates Whom Surgery is Recommended|Candidates whom surgery is recommended that received at least one dose of study drug and had at least one quantifiable concentration
10809445|NCT02315534|OG001|Outcome|Candidates Whom Surgery is Not Recommended|Candidates for whom surgery was not recommended that received at least one dose of study drug and had at least one quantifiable concentration
10809446|NCT02315534|OG000|Outcome|Candidates Whom Surgery is Not Recommended|Candidates whom surgery is either recommended or not recommended that received 28 days of study drug and provided tissue samples
10809447|NCT02315534|OG001|Outcome|Candidates Whom Surgery is Recommended|Candidates whom surgery is either recommended or not recommended that received 28 days of study drug and provided tissue samples
10809448|NCT02315534|EG000|Reported Event|Candidates Whom Surgery is Recommended|Participants whom surgery was recommended and received at least one dose of study medication (BBI608).
10809449|NCT02315534|EG001|Reported Event|Candidates Whom Surgery is Not Recommended|Patients who were not candidates for surgical resection and received at least one dose of study medication (BBI608).
10809450|NCT02279719|BG000|Baseline|Experimental Napabucasin +Sorafenib Phase IB- Dose Level 1|"Napabucasin will be administered orally twice daily in combination with sorafenib.~The dose of Napabucasin will be 160 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug."
10809451|NCT02279719|BG001|Baseline|Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2|"Napabucasin will be administered orally twice daily in combination with sorafenib.~The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug."
10809452|NCT02279719|BG002|Baseline|Experimental Amcasertib +Sorafenib Phase IB- Dose Level 1|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
10809453|NCT02279719|BG003|Baseline|Experimental Amcasertib +Sorafenib Phase IB- Dose Level 2|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809454|NCT02279719|BG004|Baseline|Experimental Napabucasin +Sorafenib Phase II|Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809455|NCT02279719|BG005|Baseline|Experimental Amcasertib +Sorafenib Phase II|Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809456|NCT02279719|BG006|Baseline|Sorafenib Phase II|Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809457|NCT02279719|BG007|Baseline|Total|Total of all reporting groups
10809458|NCT02279719|FG000|Participant Flow|Experimental Napabucasin+Sorafenib Phase IB Dose- Level 1|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 160 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809459|NCT02279719|FG001|Participant Flow|Experimental Napabucasin+Sorafenib Phase IB Dose-Level 2|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809460|NCT02279719|FG002|Participant Flow|Experimental Amcasertib +Sorafenib Phase IB Dose- Level 1|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809461|NCT02279719|FG003|Participant Flow|Experimental Amcasertib+Sorafenib Phase IB Dose-Level 2|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809462|NCT02279719|FG004|Participant Flow|Experimental Napabucasin+Sorafenib Phase II|Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809463|NCT02279719|FG005|Participant Flow|Experimental Amcasertib+Sorafenib Phase II|Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809464|NCT02279719|FG006|Participant Flow|Sorafenib Phase II|Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809465|NCT02279719|OG000|Outcome|Napabucasin+Sorafenib Phase IB- Dose Level 1|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809466|NCT02279719|OG001|Outcome|Napabucasin+Sorafenib Phase IB- Dose Level 2|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809467|NCT02279719|OG002|Outcome|Amcasertib+Sorafenib Phase IB- Dose Level 1|Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809468|NCT02279719|OG003|Outcome|Amcasertib+ Sorafenib Phase IB Dose Level 2|Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809469|NCT02279719|OG000|Outcome|Napabucasin+Sorafenib Phase IB- Dose Level 1|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809470|NCT02279719|OG001|Outcome|Napabucasin+Sorafenib Phase IB - Dose Level 2|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10821178|NCT00065611|EG000|Reported Event|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
10821179|NCT00065611|EG001|Reported Event|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
10809471|NCT02279719|OG002|Outcome|Amcasertib +Sorafenib Phase IB- Dose Level 1|Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809472|NCT02279719|OG003|Outcome|Amcasertib+ Sorafenib Phase IB- Dose Level 2|Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809473|NCT02279719|OG000|Outcome|Napabucasin+Sorafenib Phase IB|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will depend on the assigned dose-level cohort. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809474|NCT02279719|OG001|Outcome|Amcasertib+ Sorafenib Phase IB|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will depend on the assigned dose-level cohort. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809475|NCT02279719|OG000|Outcome|Experimental Napabucasin +Sorafenib Phase II|Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809476|NCT02279719|OG001|Outcome|Experimental Amcasertib+Sorafenib Phase II|Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
10809477|NCT02279719|OG002|Outcome|Sorafenib Phase II|Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
10809478|NCT02279719|OG000|Outcome|Experimental Napabucasin Plus Sorafenib Phase IB- Dose Level 1|"Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160mg daily.~Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug"
10809479|NCT02279719|OG001|Outcome|Experimental Napabucasin Plus Sorafenib Phase IB- Dose Level 2|Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809480|NCT02279719|OG002|Outcome|Experimental Amcsertib Plus Sorafenib Phase IB- Dose Level 1|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809481|NCT02279719|OG003|Outcome|Experimental Amcasetib Plus Sorafenib Phase IB- Dose Level 2|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809482|NCT02279719|OG004|Outcome|Experimental Napabucasin Plus Sorafenib Phase II|Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
10809483|NCT02279719|OG005|Outcome|Experimental Amcasertib Plus Sorafenib Phase II|Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809484|NCT02279719|OG006|Outcome|Sorafenib Phase II|Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
10809485|NCT02279719|OG000|Outcome|Experimental Napabucasin Plus Sorafenib Phase IB- Dose Level 1|"Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160mg twice daily.~Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug"
10809486|NCT02279719|OG002|Outcome|Experimental Amcasertib Plus Sorafenib Phase IB- Dose Level 1|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809487|NCT02279719|OG003|Outcome|Experimental Amcasertib Plus Sorafenib Phase IB- Dose Level 2|Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809488|NCT02279719|OG004|Outcome|Experimental Napabucasin Plus Sorafenib Phase II|Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
10809489|NCT02279719|EG000|Reported Event|Experimental Napabucasin+Sorafenib Phase IB- Dose Level 1|Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809490|NCT02279719|EG001|Reported Event|Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2|Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809491|NCT02279719|EG002|Reported Event|Experimental Amcasertib+Sorafenib Phase IB- Dose Level 1|Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809492|NCT02279719|EG003|Reported Event|Experimental Amcasertib+Sorafenib Phase IB- Dose Level 2|Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
10809493|NCT02279719|EG004|Reported Event|Experimental Napabucasin +Sorafenib Phase II|Phase II: Patients who have received at least one dose of Napabucasin (at the RP2D determined for napabucasin plus sorafenib during the Phase 1b portion) in combination with sorafenib. In the amcasertib + sorafenib arm, there were 10 patients randomized. Of these 10 patients, 3 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total to receive both amcasertib + sorafenib in Phase 2 was 7
10809494|NCT02279719|EG005|Reported Event|Experimental Amcasertib +Sorafenib Phase II|Phase II: Patients who have received at least one dose of amcasertib (at the RP2D determined for amcasertib plus sorafenib during the Phase 1b portion) in combindation with sorafenib. There were 28 total randomized and 25 who received at least 1 dose of study treatment. Of these 25 patients, 5 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total number of patients to receive both napabucasin + sorafenib in Phase 2 was 20
10809495|NCT02279719|EG006|Reported Event|Sorafenib Phase II|Phase II: Patients who have received at least one dose of sorafenib
10809496|NCT02178956|BG000|Baseline|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809497|NCT02178956|BG001|Baseline|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809498|NCT02178956|BG002|Baseline|Total|Total of all reporting groups
10809499|NCT02178956|FG000|Participant Flow|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809500|NCT02178956|FG001|Participant Flow|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809501|NCT02178956|OG000|Outcome|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809502|NCT02178956|OG001|Outcome|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809503|NCT02178956|OG000|Outcome|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
10809504|NCT02178956|OG001|Outcome|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
10809505|NCT02178956|OG000|Outcome|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients included this group received at least one dose of study drug.
10809506|NCT02178956|OG001|Outcome|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients included this group received at least one dose of study drug.
10809507|NCT02178956|EG000|Reported Event|Napabucasin + Paclitaxel|Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809508|NCT02178956|EG001|Reported Event|Placebo + Paclitaxel|Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
10809509|NCT02167945|BG000|Baseline|ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)|Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
10809510|NCT02167945|FG000|Participant Flow|ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)|Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
10809511|NCT02167945|OG000|Outcome|Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
10809512|NCT02167945|OG001|Outcome|Participants in Studies M14-222 and M14-423 Who Achieved SVR12|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
10809513|NCT02167945|OG000|Outcome|ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)|Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
10809514|NCT02167945|OG000|Outcome|Baseline Fibrosis Stage F0-F1|Participants in study M14-222 with a baseline fibrosis stage of F0 or F1
10809515|NCT02167945|OG001|Outcome|Baseline Fibrosis Stage F2|Participants in study M14-222 with a baseline fibrosis stage of F2
10809516|NCT02167945|OG002|Outcome|Baseline Fibrosis Stage F3|Participants in study M14-222 with a baseline fibrosis stage of F3
10809517|NCT02167945|OG003|Outcome|Baseline Fibrosis Stage F4|Participants in study M14-222 with a baseline fibrosis stage of F4
10809518|NCT02167945|OG000|Outcome|ABT-450/r/ABT-267 Plus ABT-333|Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen for 24 weeks.
10809519|NCT02167945|OG001|Outcome|Weight-based Ribavirin (RBV)|Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received weight-based RBV per local label for 24 weeks. Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
11286168|NCT02885012|BG001|Baseline|Switch to Letairis From Macitentan|"Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809520|NCT02167945|EG000|Reported Event|ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)|Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
10809521|NCT02097420|BG000|Baseline|Single Device Arm: Mitral Valve Replacement|Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
10809522|NCT02097420|FG000|Participant Flow|Single Device Arm: Mitral Valve Replacement|Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
10809523|NCT02097420|OG000|Outcome|Single Device Arm: Mitral Valve Replacement|Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
10809524|NCT02097420|EG000|Reported Event|Single Device Arm: Mitral Valve Replacement|Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
10809525|NCT02024607|BG000|Baseline|Napabucasin Plus FOLFOX6|All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.
10809526|NCT02024607|BG001|Baseline|Napabucasin Plus FOLFOX6 Plus Bevacizumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.
10809527|NCT02024607|BG002|Baseline|Napabucasin Plus CAPOX|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.
10809528|NCT02024607|BG003|Baseline|Napabucasin Plus FOLFIRI|All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.
10809529|NCT02024607|BG004|Baseline|Napabucasin Plus FOLFIRI Plus Bevacizumab|All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.
10809530|NCT02024607|BG005|Baseline|Napabucasin Plus Regorafenib|All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.
10809531|NCT02024607|BG006|Baseline|Napabucasin Plus Irinotecan|All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.
10809532|NCT02024607|BG007|Baseline|Total|Total of all reporting groups
11205540|NCT02229474|OG000|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
11205541|NCT02229474|OG001|Outcome|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
11286169|NCT02885012|BG002|Baseline|Total|Total of all reporting groups
10809533|NCT02024607|FG000|Participant Flow|Napabucasin Plus FOLFOX6|All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.
10809534|NCT02024607|FG001|Participant Flow|Napabucasin Plus FOLFOX6 Plus Bevacizumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.
10809535|NCT02024607|FG002|Participant Flow|Napabucasin Plus CAPOX|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.
10809536|NCT02024607|FG003|Participant Flow|Napabucasin Plus FOLFIRI|All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.
10809537|NCT02024607|FG004|Participant Flow|Napabucasin Plus FOLFIRI Plus Bevacizumab|All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.
10809538|NCT02024607|FG005|Participant Flow|Napabucasin Plus Regorafenib|All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.
10809539|NCT02024607|FG006|Participant Flow|Napabucasin Plus Irinotecan|All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.
10809540|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFOX6|Napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion. Patients included in this group received at least one dose of study drug.
10809541|NCT02024607|OG001|Outcome|Napabucasin Plus FOLFOX6 Plus Bevacizumab|Napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion. Patients included in this group received at least one dose of study drug.
10809542|NCT02024607|OG002|Outcome|Napabucasin Plus CAPOX|Napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle. Patients included in this group received at least one dose of study drug.
10809543|NCT02024607|OG003|Outcome|Napabucasin Plus FOLFIRI|Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.
11244298|NCT02509936|EG000|Reported Event|Standard of Care Arm|"In this arm enrolled children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10809544|NCT02024607|OG004|Outcome|Napabucasin Plus FOLFIRI Plus Bevacizumab|Napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.
10809545|NCT02024607|OG005|Outcome|Napabucasin Plus Regorafenib|Napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle. Patients included in this group received at least one dose of study drug.
10809546|NCT02024607|OG006|Outcome|Napabucasin Plus Irinotecan|Napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.
10809547|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFIRI|Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter . Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809548|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFOX6|All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.
10809549|NCT02024607|OG001|Outcome|Napabucasin Plus FOLFOX6 Plus Bevacizumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.
10809550|NCT02024607|OG002|Outcome|Napabucasin Plus CAPOX|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.
10809551|NCT02024607|OG003|Outcome|Napabucasin Plus FOLFIRI|All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.
10809552|NCT02024607|OG004|Outcome|Napabucasin Plus FOLFIRI Plus Bevacizumab|All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.
10809553|NCT02024607|OG005|Outcome|Napabucasin Plus Regorafenib|All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.
10809554|NCT02024607|OG006|Outcome|Napabucasin Plus Irinotecan|All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.
10809555|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFOX6|Napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
11286170|NCT02885012|FG000|Participant Flow|Switch to Letairis From Bosentan|"Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809556|NCT02024607|OG001|Outcome|Napabucasin Plus FOLFOX6 Plus Bevacizumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809557|NCT02024607|OG002|Outcome|Napabucasin Plus CAPOX|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809558|NCT02024607|OG003|Outcome|Napabucasin Plus FOLFIRI|All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809559|NCT02024607|OG004|Outcome|Napabucasin Plus FOLFIRI Plus Bevacizumab|All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809560|NCT02024607|OG005|Outcome|Napabucasin Plus Regorafenib|All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809561|NCT02024607|OG006|Outcome|Napabucasin Plus Irinotecan|All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809562|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFIRI|All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.
10809563|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFIRI|Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one on study scan or died from any cause.
10809564|NCT02024607|OG000|Outcome|Napabucasin Plus FOLFIRI|Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter . The patients in this subgroup were assessed to have FOLFIRI/XELIRI refractory metastatic colorectal cancer prior to enrollment.
11205542|NCT02229474|OG000|Outcome|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location."
11215426|NCT02299167|FG000|Participant Flow|Single Group Study / Saddle Block|"The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method~Dixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."
10809565|NCT02024607|EG000|Reported Event|Napabucasin Plus FOLFOX6|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.
10809566|NCT02024607|EG001|Reported Event|Napabucasin Plus FOLFOX6 Plus Bevacizumab|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.
10809567|NCT02024607|EG002|Reported Event|Napabucasin Plus CAPOX|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.
10809568|NCT02024607|EG003|Reported Event|Napabucasin Plus FOLFIRI|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.
10809569|NCT02024607|EG004|Reported Event|Napabucasin Plus FOLFIRI Plus Bevacizumab|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.
10809570|NCT02024607|EG005|Reported Event|Napabucasin Plus Regorafenib|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.
10809571|NCT02024607|EG006|Reported Event|Napabucasin Plus Irinotecan|All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.
10821180|NCT00065806|BG000|Baseline|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821181|NCT00065806|BG001|Baseline|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821182|NCT00065806|BG002|Baseline|Total|Total of all reporting groups
10821183|NCT00065806|FG000|Participant Flow|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
11286171|NCT02885012|FG001|Participant Flow|Switch to Letairis From Macitentan|"Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809572|NCT01925131|BG000|Baseline|CVP + Inotuzumab Dose Level 1|"Combination chemotherapy and inotuzumab ozogamicin � Dose level 1~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809573|NCT01925131|BG001|Baseline|CVP + Inotuzumab Dose Level 2|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 2~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809574|NCT01925131|BG002|Baseline|CVP + Inotuzumab Dose Level 3|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 3~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809575|NCT01925131|BG003|Baseline|CVP + Inotuzumab Dose Level 4|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 4~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809576|NCT01925131|BG004|Baseline|CVP + Inotuzumab Dose Level 5|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 5~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809577|NCT01925131|BG005|Baseline|CVP + Inotuzumab MTD|"Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809578|NCT01925131|BG006|Baseline|Total|Total of all reporting groups
10809579|NCT01925131|FG000|Participant Flow|CVP + Inotuzumab Dose Level 1|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 1~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809580|NCT01925131|FG001|Participant Flow|CVP + Inotuzumab Dose Level 2|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 2~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809581|NCT01925131|FG002|Participant Flow|CVP + Inotuzumab Dose Level 3|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 3~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809582|NCT01925131|FG003|Participant Flow|CVP + Inotuzumab Dose Level 4|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 4~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809583|NCT01925131|FG004|Participant Flow|CVP + Inotuzumab Dose Level 5|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 5~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809584|NCT01925131|FG005|Participant Flow|CVP + Inotuzumab MTD (Expansion Cohort)|"Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose (Expansion Cohort)~Patients receive 750 mg/m2 cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809585|NCT01925131|OG000|Outcome|CVP + Inotuzumab|"Combination chemotherapy and inotuzumab ozogamicin~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809586|NCT01925131|OG000|Outcome|CVP + Inotuzumab MTD|"Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809587|NCT01925131|OG000|Outcome|CVP + Inotuzumab Dose Level 1|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 1~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
11215427|NCT02299167|OG000|Outcome|Single Group Study / Saddle Block|"The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method~Dixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."
10809588|NCT01925131|OG001|Outcome|CVP + Inotuzumab Dose Level 2|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 2~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809589|NCT01925131|OG002|Outcome|CVP + Inotuzumab Dose Level 3|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 3~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809590|NCT01925131|OG003|Outcome|CVP + Inotuzumab Dose Level 4|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 4~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809591|NCT01925131|OG004|Outcome|CVP + Inotuzumab Dose Level 5|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 5~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809592|NCT01925131|OG005|Outcome|CVP + Inotuzumab MTD|"Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809593|NCT01925131|EG000|Reported Event|CVP + Inotuzumab Dose Level 1|"Combination chemotherapy and inotuzumab ozogamicin � Dose level 1~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809594|NCT01925131|EG001|Reported Event|CVP + Inotuzumab Dose Level 2|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 2~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
11205543|NCT02229474|EG000|Reported Event|CST Intervention|"We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.~CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life."
11205544|NCT02229474|EG001|Reported Event|Group 2|and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
10809595|NCT01925131|EG002|Reported Event|CVP + Inotuzumab Dose Level 3|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 3~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809596|NCT01925131|EG003|Reported Event|CVP + Inotuzumab Dose Level 4|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 4~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809597|NCT01925131|EG004|Reported Event|CVP + Inotuzumab Dose Level 5|"Combination chemotherapy and inotuzumab ozogamicin - Dose level 5~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
10809598|NCT01925131|EG005|Reported Event|CVP + Inotuzumab MTD|"Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose~Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
11205545|NCT02229487|BG000|Baseline|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
11205546|NCT02229487|BG001|Baseline|Short Sleeper|Sleep duration as measured by actigraphy =<5.75 h/night
11205547|NCT02229487|BG002|Baseline|Total|Total of all reporting groups
11205548|NCT02229487|FG000|Participant Flow|Normal Sleepers|"Prediabetes patients with normal sleep duration (>=6.5 hours/ night) as measured objectively~Oral glucose tolerance"
10809599|NCT01776307|BG000|Baseline|Napabucasin Plus Cetuximab|All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously
10809600|NCT01776307|BG001|Baseline|Napabucasin Plus Panitumumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle
10809601|NCT01776307|BG002|Baseline|Napabucasin Plus Capecitabine|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks
10809602|NCT01776307|BG003|Baseline|Total|Total of all reporting groups
10809603|NCT01776307|FG000|Participant Flow|Napabucasin Plus Cetuximab|All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously
10809604|NCT01776307|FG001|Participant Flow|Napabucasin Plus Panitumumab|All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle
10809605|NCT01776307|FG002|Participant Flow|Napabucasin Plus Capecitabine|All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks
10809606|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809607|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809608|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
10809609|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients in this group had a baseline scan and at least one on study scan or died from any cause.
10809610|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one on study scan or died from any cause.
10809611|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one on study scan or died from any cause
10809612|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle.
10809613|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle.
11205549|NCT02229487|FG001|Participant Flow|Short Sleepers|"Prediabetes patients with short sleep duration (=<5.75 hours/night) as measured objectively~Oral glucose tolerance"
10809614|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks.
10809615|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
10809616|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
10809617|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
10809618|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
11205550|NCT02229487|OG000|Outcome|Short Sleepers|Sleep duration as measured by actigraphy =<5.75 h/night
11205551|NCT02229487|OG001|Outcome|Normal Sleepers|Sleep duration as measured by actigraphy >=6.5h/night
10809619|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
10809620|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
10809621|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
10809622|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
10809623|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
11205552|NCT02229487|EG000|Reported Event|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
11205553|NCT02229487|EG001|Reported Event|Short Sleeper|Sleep duration as measured by actigraphy =<5.7 h/night
11205554|NCT02229513|BG000|Baseline|Control|Normal cesarean technique.
10809624|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients included in this group needed to have on treatment biopsy
10809625|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group needed to have on treatment biopsy
10809626|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group needed to have on treatment biopsy.
10809627|NCT01776307|OG000|Outcome|Napabucasin Plus Cetuximab|Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group received at least one dose of study drug.
10809628|NCT01776307|OG001|Outcome|Napabucasin Plus Panitumumab|Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group received at least one dose of study drug.
10809629|NCT01776307|OG002|Outcome|Napabucasin Plus Capecitabine|Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group received at least one dose of study drug.
10809630|NCT01776307|EG000|Reported Event|Napabucasin Plus Cetuximab|All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously
10809631|NCT01776307|EG001|Reported Event|Napabucasin Plus Panitumumab|All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle
10809632|NCT01776307|EG002|Reported Event|Napabucasin Plus Capecitabine|All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks
10809633|NCT01623167|BG000|Baseline|hATG, CsA, EPAG Day 14 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6~hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6"
10809634|NCT01623167|BG001|Baseline|hATG, CsA, EPAG Day 14 to Month 3|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3~hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3"
10809635|NCT01623167|BG002|Baseline|hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6~hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6"
10809636|NCT01623167|BG003|Baseline|Total|Total of all reporting groups
10809637|NCT01623167|FG000|Participant Flow|hATG, CsA, EPAG Day 14 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6~hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6"
10809638|NCT01623167|FG001|Participant Flow|hATG, CsA, EPAG Day 14 to Month 3|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3~hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3"
10809639|NCT01623167|FG002|Participant Flow|hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6~hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6"
10809640|NCT01623167|OG000|Outcome|hATG, CsA, EPAG Day 14 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6~hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6"
10809641|NCT01623167|OG001|Outcome|hATG, CsA, EPAG Day 14 to Month 3|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3~hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3"
10809642|NCT01623167|OG002|Outcome|hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6~hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6"
10809643|NCT01623167|EG000|Reported Event|hATG, CsA, EPAG Day 14 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 6~hATG/CsA /eltrombopag -Cohort 1: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6"
10809644|NCT01623167|EG001|Reported Event|hATG, CsA, EPAG Day 14 to Month 3|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6, and receive eltrombopag day 14 to month 3~hATG/CsA /eltrombopag Cohort 2: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3"
11286172|NCT02885012|OG000|Outcome|Switch to Letairis From Bosentan|"Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809645|NCT01623167|EG002|Reported Event|hATG, CsA (Dose Reduced), EPAG Day 1 to Month 6|"Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18months, and receive eltrombopag day 1 to month 6~hATG/CsA /eltrombopag Cohort 3: hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6"
10809646|NCT01535274|BG000|Baseline|Propofol|"Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809647|NCT01535274|BG001|Baseline|Desflurane|"Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809648|NCT01535274|BG002|Baseline|Total|Total of all reporting groups
10809649|NCT01535274|FG000|Participant Flow|Propofol|"Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809650|NCT01535274|FG001|Participant Flow|Desflurane|"Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809651|NCT01535274|OG000|Outcome|Propofol|"Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809652|NCT01535274|OG001|Outcome|Desflurane|"Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809653|NCT01535274|OG000|Outcome|Propofol|"Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809654|NCT01535274|OG001|Outcome|Desflurane|"Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809655|NCT01535274|EG000|Reported Event|Propofol|"Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
10809656|NCT01535274|EG001|Reported Event|Desflurane|"Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy.~Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 30mmHg - beach chair position.~FIO2 100%, PETCO2 45mmHg - beach chair position.~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
11205555|NCT02229513|BG001|Baseline|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
11205556|NCT02229513|BG002|Baseline|Total|Total of all reporting groups
10809657|NCT00544830|BG000|Baseline|Treatment (Androgen Therapy, Radiation Therapy)|"ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.~RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given via injection"
10809658|NCT00544830|FG000|Participant Flow|Treatment (Androgen Therapy, Radiation Therapy)|"ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.~RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given via injection"
10809659|NCT00544830|OG000|Outcome|Treatment (Androgen Therapy, Radiation Therapy)|"ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.~RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given via injection"
10809660|NCT00544830|EG000|Reported Event|Treatment (Androgen Therapy, Radiation Therapy)|"ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.~RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given via injection"
10809661|NCT00539981|BG000|Baseline|FluBlok (Lots A, B, C)|Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809662|NCT00539981|BG001|Baseline|Placebo|Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809663|NCT00539981|BG002|Baseline|Total|Total of all reporting groups
10809664|NCT00539981|FG000|Participant Flow|FluBlok (Lots A, B, C)|Participants received a single 0.5 milliliters (mL) dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809665|NCT00539981|FG001|Participant Flow|Placebo|Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809666|NCT00539981|OG000|Outcome|FluBlok (Lots A, B, C)|Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809667|NCT00539981|OG001|Outcome|Placebo|Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809668|NCT00539981|OG000|Outcome|FluBlok: Lot A|Participants received a single 0.5 mL dose of FluBlok vaccine from Lot A, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809669|NCT00539981|OG001|Outcome|FluBlok: Lot B|Participants received a single 0.5 mL dose of FluBlok vaccine from Lot B, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809670|NCT00539981|OG002|Outcome|FluBlok: Lot C|Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809671|NCT00539981|EG000|Reported Event|FluBlok (Lots A, B, C)|Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10809672|NCT00539981|EG001|Reported Event|Placebo|Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
10967065|NCT00891176|BG003|Baseline|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10967066|NCT00891176|BG004|Baseline|Total|Total of all reporting groups
11205557|NCT02229513|FG000|Participant Flow|Control|Normal cesarean technique.
11286173|NCT02885012|OG001|Outcome|Switch to Letairis From Macitentan|"Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809673|NCT04732819|BG000|Baseline|Usual Care|Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
10809674|NCT04732819|BG001|Baseline|High Touch|"Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.~High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:~Identify and engage a Facility Opinion Leader.~Employ Consenting Specialists to facilitate the clinical consent for vaccination process.~Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.~Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.~Acquire additional COVID-19 testing kits using funds provided by our research team."
10809675|NCT04732819|BG002|Baseline|Total|Total of all reporting groups
10809676|NCT04732819|FG000|Participant Flow|Usual Care|Staff and residents in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
10809677|NCT04732819|FG001|Participant Flow|High Touch|"Staff and residents in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.~High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:~Identify and engage a Facility Opinion Leader.~Employ Consenting Specialists to facilitate the clinical consent for vaccination process.~Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.~Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.~Acquire additional COVID-19 testing kits using funds provided by our research team."
10809678|NCT04732819|OG000|Outcome|Usual Care|Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
10809679|NCT04732819|OG001|Outcome|High Touch|"Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.~High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:~Identify and engage a Facility Opinion Leader.~Employ Consenting Specialists to facilitate the clinical consent for vaccination process.~Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.~Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.~Acquire additional COVID-19 testing kits using funds provided by our research team."
10809680|NCT04732819|EG000|Reported Event|Usual Care|Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
10809681|NCT04732819|EG001|Reported Event|High Touch|"Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.~High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:~Identify and engage a Facility Opinion Leader.~Employ Consenting Specialists to facilitate the clinical consent for vaccination process.~Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.~Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.~Acquire additional COVID-19 testing kits using funds provided by our research team."
10847593|NCT00284050|OG001|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10809682|NCT04732338|BG000|Baseline|Study Arm - Osteopathic Manipulative Therapy|"Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:~Musculoskeletal examination of the cervical spine. Testing will be comprised of :~Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.~Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.~Patient placed supine on the examination table.~Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.~Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.~Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths."
10809683|NCT04732338|BG001|Baseline|Control - Standard of Care|Standard of care including physical therapy, occupational therapy and over the counter medication.
10809684|NCT04732338|BG002|Baseline|Total|Total of all reporting groups
10809685|NCT04732338|FG000|Participant Flow|Study Arm - Osteopathic Manipulative Therapy|"Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:~Musculoskeletal examination of the cervical spine. Testing will be comprised of :~Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.~Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.~Patient placed supine on the examination table.~Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.~Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.~Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths."
10809686|NCT04732338|FG001|Participant Flow|Control - Standard of Care|Standard of care including physical therapy, occupational therapy and over the counter medication.
10809687|NCT04732338|OG000|Outcome|Study Arm - Osteopathic Manipulative Therapy|"Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:~Musculoskeletal examination of the cervical spine. Testing will be comprised of :~Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.~Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.~Patient placed supine on the examination table.~Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.~Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.~Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths."
10809688|NCT04732338|OG001|Outcome|Control - Standard of Care|Standard of care including physical therapy, occupational therapy and over the counter medication.
10809689|NCT04732338|EG000|Reported Event|Study Arm - Osteopathic Manipulative Therapy|"Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:~Musculoskeletal examination of the cervical spine. Testing will be comprised of :~Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.~Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.~Patient placed supine on the examination table.~Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.~Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.~Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths."
10809690|NCT04732338|EG001|Reported Event|Control - Standard of Care|Standard of care including physical therapy, occupational therapy and over the counter medication.
11286174|NCT02885012|EG000|Reported Event|Switch to Letairis From Bosentan|"Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10847594|NCT00284050|OG002|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10809691|NCT04728802|BG000|Baseline|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by care provider~Proxalutamide: Proxalutamide 300mg q.d"
10809692|NCT04728802|BG001|Baseline|Placebo + Usual Care|"Placebo + usual care as determined by care provider~Placebo: Placebo pill"
10809693|NCT04728802|BG002|Baseline|Total|Total of all reporting groups
10809694|NCT04728802|FG000|Participant Flow|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by care provider~Proxalutamide: Proxalutamide 300mg q.d"
10809695|NCT04728802|FG001|Participant Flow|Placebo + Usual Care|"Placebo + usual care as determined by care provider~Placebo: Placebo pill"
10809696|NCT04728802|OG000|Outcome|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by care provider~Proxalutamide: Proxalutamide 300mg q.d"
11205558|NCT02229513|FG001|Participant Flow|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
11205559|NCT02229513|OG000|Outcome|Control|Normal cesarean technique.
10809697|NCT04728802|OG001|Outcome|Placebo + Usual Care|"Placebo + usual care as determined by care provider~Placebo: Placebo pill"
10809698|NCT04728802|EG000|Reported Event|Proxalutamide + Usual Care|"Proxalutamide + usual care as determined by care provider~Proxalutamide: Proxalutamide 300mg q.d"
10809699|NCT04728802|EG001|Reported Event|Placebo + Usual Care|"Placebo + usual care as determined by care provider~Placebo: Placebo pill"
10809700|NCT04728594|BG000|Baseline|Delayed Contact|This group will not receive an email for at least two days.
10809701|NCT04728594|BG001|Baseline|Social Proof|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.~Social Proof: Email~Scarcity Message: Email"
10809702|NCT04728594|BG002|Baseline|Reframing Side Effects and Adverse Reactions|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.~Reframing: Email~Scarcity Message: Email"
10809703|NCT04728594|BG003|Baseline|Total|Total of all reporting groups
10809704|NCT04728594|FG000|Participant Flow|Delayed Contact|This group will not receive an email for at least two days.
10809705|NCT04728594|FG001|Participant Flow|Social Proof|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.~Social Proof: Email~Scarcity Message: Email"
10809706|NCT04728594|FG002|Participant Flow|Reframing Side Effects and Adverse Reactions|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.~Reframing: Email~Scarcity Message: Email"
10809707|NCT04728594|OG000|Outcome|Delayed Contact|This group will not receive an email for at least two days.
10809708|NCT04728594|OG001|Outcome|Social Proof|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.~Social Proof: Email~Scarcity Message: Email"
11205560|NCT02229513|OG001|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
11205561|NCT02229513|EG000|Reported Event|Control|Normal cesarean technique.
11205562|NCT02229513|EG001|Reported Event|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
11205563|NCT02229539|BG000|Baseline|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
10809709|NCT04728594|OG002|Outcome|Reframing Side Effects and Adverse Reactions|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.~Reframing: Email~Scarcity Message: Email"
10809710|NCT04728594|OG000|Outcome|Social Proof|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.~Social Proof: Email~Scarcity Message: Email"
10809711|NCT04728594|OG001|Outcome|Reframing Side Effects and Adverse Reactions|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.~Reframing: Email~Scarcity Message: Email"
10809712|NCT04728594|EG000|Reported Event|Delayed Contact|This group will not receive an email for at least two days.
10809713|NCT04728594|EG001|Reported Event|Social Proof|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.~Social Proof: Email~Scarcity Message: Email"
10809714|NCT04728594|EG002|Reported Event|Reframing Side Effects and Adverse Reactions|"This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.~Reframing: Email~Scarcity Message: Email"
10821184|NCT00065806|FG001|Participant Flow|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821185|NCT00065806|OG000|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821186|NCT00065806|OG001|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821187|NCT00065806|EG000|Reported Event|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
11092256|NCT01538615|FG000|Participant Flow|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
11286175|NCT02885012|EG001|Reported Event|Switch to Letairis From Macitentan|"Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)~Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan."
10809715|NCT04725500|BG000|Baseline|Auto-titrating EPAP|"ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.~Auto-Titrating EPAP: In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation."
10809716|NCT04725500|FG000|Participant Flow|Auto-titrating EPAP|"ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.~Auto-Titrating EPAP: In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation."
10809717|NCT04725500|OG000|Outcome|Auto-titrating EPAP|"ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.~Auto-Titrating EPAP: In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation."
10809718|NCT04725500|EG000|Reported Event|Auto-titrating EPAP|"ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.~Auto-Titrating EPAP: In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation."
10809737|NCT04709068|BG000|Baseline|COVID19+|Current Health: wearable device and tablet used to collect health measures at home
10809738|NCT04709068|FG000|Participant Flow|COVID19+|Current Health: wearable device and tablet used to collect health measures at home
10809739|NCT04709068|OG000|Outcome|COVID19+|Current Health: wearable device and tablet used to collect health measures at home
10809740|NCT04709068|EG000|Reported Event|COVID19+|Current Health: wearable device and tablet used to collect health measures at home
10809741|NCT04704713|BG000|Baseline|Afamelanotide|"Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Afamelanotide"
10809742|NCT04704713|BG001|Baseline|Placebo|"Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Placebo"
10809743|NCT04704713|BG002|Baseline|Total|Total of all reporting groups
10809744|NCT04704713|FG000|Participant Flow|Afamelanotide|"Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Afamelanotide"
10809745|NCT04704713|FG001|Participant Flow|Placebo|"Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Placebo"
10809746|NCT04704713|OG000|Outcome|Afamelanotide|"Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Afamelanotide"
10809747|NCT04704713|OG001|Outcome|Placebo|"Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Placebo"
10809748|NCT04704713|EG000|Reported Event|Afamelanotide|"Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Afamelanotide"
10809749|NCT04704713|EG001|Reported Event|Placebo|"Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.~Placebo"
10809750|NCT04698993|BG000|Baseline|Symptomatic|"Collection of specimens from symptomatic COVID-19 positive participants~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809751|NCT04698993|BG001|Baseline|Asymptomatic|"Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809752|NCT04698993|BG002|Baseline|Total|Total of all reporting groups
10809753|NCT04698993|FG000|Participant Flow|Symptomatic|"Collection of specimens from symptomatic COVID-19 positive participants~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809754|NCT04698993|FG001|Participant Flow|Asymptomatic|"Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809755|NCT04698993|OG000|Outcome|Symptomatic|"Collection of specimens from symptomatic COVID-19 positive participants~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809756|NCT04698993|OG001|Outcome|Asymptomatic|"Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809757|NCT04698993|EG000|Reported Event|Symptomatic|"Collection of specimens from symptomatic COVID-19 positive participants~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809758|NCT04698993|EG001|Reported Event|Asymptomatic|"Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2~Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test"
10809763|NCT04693078|BG000|Baseline|Intervention Arm|"Consecutive patients undergoing screening or surveillance colonoscopy in whom a new polyp detection system based on deep learning will be used during the procedure.~AI polyp detection system based on deep learning: A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy."
10809764|NCT04693078|FG000|Participant Flow|Intervention Arm|"Consecutive patients undergoing screening or surveillance colonoscopy in whom a new polyp detection system based on deep learning will be used during the procedure.~AI polyp detection system based on deep learning: A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy."
11092257|NCT01538615|FG001|Participant Flow|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
10809719|NCT04724538|BG000|Baseline|Patient With COVID-19 Pneumonia|"Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.~99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol"
10809720|NCT04724538|BG001|Baseline|Patient With COVID-19 Pneumonia Without Intervention|Blood tests at 1, 3 and 7 days.
10809721|NCT04724538|BG002|Baseline|Total|Total of all reporting groups
10809722|NCT04724538|FG000|Participant Flow|Patient With COVID-19 Pneumonia|"Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.~99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol"
10809723|NCT04724538|FG001|Participant Flow|Patient With COVID-19 Pneumonia Without Intervention|Blood tests at 1, 3 and 7 days.
10809724|NCT04724538|OG000|Outcome|Patient With COVID-19 Pneumonia|"Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.~99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol"
10809725|NCT04724538|OG001|Outcome|Patient With COVID-19 Pneumonia Without Intervention|Blood tests at 1, 3 and 7 days.
10809726|NCT04724538|EG000|Reported Event|Patient With COVID-19 Pneumonia|"Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.~99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol"
10809727|NCT04724538|EG001|Reported Event|Patient With COVID-19 Pneumonia Without Intervention|Blood tests at 1, 3 and 7 days.
10809759|NCT04697888|BG000|Baseline|Overall Study|"Use of Omegaven for patients with parenteral nutrition associated liver disease.~Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day."
11092258|NCT01538615|OG000|Outcome|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
10809760|NCT04697888|FG000|Participant Flow|Overall Study|"Use of Omegaven for patients with parenteral nutrition associated liver disease.~Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day."
10809761|NCT04697888|OG000|Outcome|Overall Study|"Use of Omegaven for patients with parenteral nutrition associated liver disease.~Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day."
10809762|NCT04697888|EG000|Reported Event|Overall Study|"Use of Omegaven for patients with parenteral nutrition associated liver disease.~Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day."
10809765|NCT04693078|OG000|Outcome|Intervention Arm|"Consecutive patients undergoing screening or surveillance colonoscopy in whom a new polyp detection system based on deep learning will be used during the procedure.~AI polyp detection system based on deep learning: A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy."
10809766|NCT04693078|EG000|Reported Event|Intervention Arm|"Consecutive patients undergoing screening or surveillance colonoscopy in whom a new polyp detection system based on deep learning will be used during the procedure.~AI polyp detection system based on deep learning: A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy."
10821188|NCT00065806|EG001|Reported Event|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
10821189|NCT00066066|BG000|Baseline|Scaling and Root Planing (SRP) Only|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821190|NCT00066066|BG001|Baseline|SRP and Metronidazole (MET)|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
11092259|NCT01538615|OG001|Outcome|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
10809728|NCT04716426|BG000|Baseline|Tetracycline Hydrochloride 3%|"4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride."
10809729|NCT04716426|BG001|Baseline|Placebo|"4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Placebo: Formulation composed of FDA approved inactive ingredients."
10809730|NCT04716426|BG002|Baseline|Total|Total of all reporting groups
10809731|NCT04716426|FG000|Participant Flow|Tetracycline Hydrochloride 3%|"4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride."
10809732|NCT04716426|FG001|Participant Flow|Placebo|"4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Placebo: Formulation composed of FDA approved inactive ingredients."
10809733|NCT04716426|OG000|Outcome|Tetracycline Hydrochloride 3%|"4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride."
10809734|NCT04716426|OG001|Outcome|Placebo|"4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Placebo: Formulation composed of FDA approved inactive ingredients."
10809735|NCT04716426|EG000|Reported Event|Tetracycline Hydrochloride 3%|"4 drops of tetracycline hydrochloride 3% (APT™ T3X) applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Tetracycline hydrochloride 3%: Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride."
10809736|NCT04716426|EG001|Reported Event|Placebo|"4 drops of placebo applied inside of the nasal channels and inside of nostrils, once a day, every day for 21 days (except health professionals that will be instructed to use 4 drops of APT™ T3X twice a day, every day for 21 days.~Placebo: Formulation composed of FDA approved inactive ingredients."
10809767|NCT04688346|BG000|Baseline|Saline First, Then Epinephrine|"Saline Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809768|NCT04688346|BG001|Baseline|First Epinephrine, Then Saline|"Racemic Epinephrine Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809769|NCT04688346|BG002|Baseline|Total|Total of all reporting groups
10809770|NCT04688346|FG000|Participant Flow|Saline First, Then Epinephrine|"Saline Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809771|NCT04688346|FG001|Participant Flow|First Epinephrine, Then Saline|"Racemic Epinephrine Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809772|NCT04688346|OG000|Outcome|Control|"Saline Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809773|NCT04688346|OG001|Outcome|Intervention|"Racemic Epinephrine Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809774|NCT04688346|EG000|Reported Event|Control|"Saline Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809775|NCT04688346|EG001|Reported Event|Intervention|"Racemic Epinephrine Pellet~HemeRX epinephrine pellets: Racemic Epinephrine Pellet"
10809776|NCT04684992|BG000|Baseline|GEBT Telehealth Administration Usability|"Establish the usability of a telehealth platform for the administration of GEBT~GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT"
10809777|NCT04684992|FG000|Participant Flow|GEBT Telehealth Administration Usability|"Establish the usability of a telehealth platform for the administration of GEBT~GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT"
10809778|NCT04684992|OG000|Outcome|GEBT Telehealth Administration Usability|"Establish the usability of a telehealth platform for the administration of GEBT~GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT"
10809779|NCT04684992|EG000|Reported Event|GEBT Telehealth Administration Usability|"Establish the usability of a telehealth platform for the administration of GEBT~GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT"
10809780|NCT04674644|BG000|Baseline|Analysing the Psychosocial Effects of COVID-19 Pandemic on Dental Professionals|"Data were collected by sending an online survey questionnaire to dentists working in public and university hospitals, including both general dentists and specialists.~The survey consisted of a questionnaire that included sociodemographic data (age range, gender, marital status, composition of household, systemic disease, professional area, years of clinical experience, number of patients treated daily, smoking status, alcohol consumption), epidemic-related questions, and scales measuring the fear and anxiety levels of the participants. In the last part of the survey, the levels of fear and anxiety were assessed by the FCV-19S and CAS."
10809781|NCT04674644|FG000|Participant Flow|Analysing the Psychosocial Effects of COVID-19 Pandemic|General dentists and specialists analyzed during COVID-19 pandemic
10809782|NCT04674644|OG000|Outcome|Analysing the Psychosocial Effects of COVID-19 Pandemic on Dental Professionals|General dentists and specialists
10809783|NCT04674644|OG000|Outcome|The Psychosocial Effects of COVID-19 Using the Turkish Version of the Coronavirus Anxiety Scale|General dentists and specialists
10809784|NCT04674644|EG000|Reported Event|Analysing the Psychosocial Effects of COVID-19 Pandemic on Dental Professionals|The psychosocial effects of COVID-19 pandemic on general dentists and specialists
10809785|NCT04673214|BG000|Baseline|Double Therapy|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809786|NCT04673214|BG001|Baseline|Triple Therapy|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS <80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809787|NCT04673214|BG002|Baseline|Total|Total of all reporting groups
10809788|NCT04673214|FG000|Participant Flow|Triple Therapy|65 triple therapy patients received the assigned intervention with Azithromycin tablets 500 mg 1 tablet in a single dose the first day and then half a tablet (250 mg) orally every 24 4 days, ivermectin tablets of 200 mcg calculated according to your weight and dose, will be every 24 hours for 2 days and Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days and Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809789|NCT04673214|FG001|Participant Flow|Double Therapy|46 double therapy patients received the assigned intervention with Azithromycin 500 mg tablets 1 single dose tablet on the first day and then half a tablet (250 mg) orally every 24 4 days and rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days with Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809790|NCT04673214|OG000|Outcome|DOUBLE THERAPY|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809791|NCT04673214|OG001|Outcome|TRIPLE THERAPY|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS <80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809792|NCT04673214|OG000|Outcome|Double Therapy|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
11244299|NCT02509936|EG001|Reported Event|Home-based Education|"In the intervention arm, children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they received monthly home visits from a community health promoter who provided detailed dietary assessments and individualized dietary coaching and education to parents.~Home-based nutrition education: Health promoters used 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)"
10809793|NCT04673214|OG001|Outcome|Triple Therapy|The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS <80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809794|NCT04673214|OG000|Outcome|Modification of Evolution Clinic|Improvement of the clinical health conditions of symptoms such as headache, cough, fever, conjunctivitis, myalgia, arthralgia, rhinorrhea, odynophagia, anosmia, chest pain, dyspnea after the administration of the dual therapy of Azithromycin / Ribaroxaban / Paracetamol and the Azithromycin / Ivermectin / Ribaroxaban / Paracetamol triple therapy in patients with mild Covid-19 clinical phase performed by video call monitoring lasting 15-20 minutes for 14 days.
10809795|NCT04673214|OG001|Outcome|Therapeutic Failure|Lack of efficacy after the administration of Azithromycin / Ribaroxaban / Paracetamol dual therapy and Azithromycin / Ivermectin / Ribaroxaban / Paracetamol triple therapy in the registry of clinical health conditions of symptoms such as headache, cough, fever, conjunctivitis, myalgia, arthralgia , rhinorrhea, odynophagia, anosmia, chest pain, dyspnea, of patients with mild clinical phase Covid-19 performed by monitoring with a duration of 15-20 minutes during 14 days of follow-up.
10809796|NCT04673214|EG000|Reported Event|Dual Therapy Adverse Event|Record of adverse reactions of Blood and lymphatic system disorders, Heartdisorders, Ear and labyrinth disorders,Gastrointestinal disorders and Musculoskeletal and connective tissue disorders with the following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809797|NCT04673214|EG001|Reported Event|Adverse Event Triple Therapy|Record of adverse reactions of Blood and lymphatic system disorders, Heartdisorders, Ear and labyrinth disorders,Gastrointestinal disorders and Musculoskeletal and connective tissue disorders with the following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS <80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
10809798|NCT04668989|BG000|Baseline|Overall Study|"Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.~stenfilcon A - (Test lens)~kalifilcon A - (Control Lens)"
10809799|NCT04668989|FG000|Participant Flow|Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens)|"Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.~stenfilcon A - (Test lens)~kalifilcon A - (Control lens)"
10809800|NCT04668989|FG001|Participant Flow|Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens)|"Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.~stenfilcon A - (Test lens)~kalifilcon A - (Control Lens)"
10809801|NCT04668989|OG000|Outcome|Stenfilcon A - (Test Lens)|"Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.~stenfilcon A - (Test lens)"
10809802|NCT04668989|OG001|Outcome|Kalifilcon A - (Control Lens)|"Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.~kalifilcon A - (Control lens)"
10809803|NCT04668989|EG000|Reported Event|Stenfilcon A - (Test Lens)|Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.
10809804|NCT04668989|EG001|Reported Event|Kalifilcon A - (Control Lens)|Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
10809805|NCT04668352|BG000|Baseline|Placebo|Placebo: Placebo
10809806|NCT04668352|BG001|Baseline|Dactolisib 10mg Once Daily|Dactolisib: TORC1 inhibitor
10809807|NCT04668352|BG002|Baseline|Total|Total of all reporting groups
10809808|NCT04668352|FG000|Participant Flow|Placebo|Placebo: Placebo
10809809|NCT04668352|FG001|Participant Flow|Dactolisib 10mg Once Daily|Dactolisib: TORC1 inhibitor
10809810|NCT04668352|OG000|Outcome|Placebo|Placebo: Placebo
10809811|NCT04668352|OG001|Outcome|Dactolisib 10mg Once Daily|Dactolisib: TORC1 inhibitor
10809812|NCT04668352|EG000|Reported Event|Placebo|Placebo: Placebo
10809813|NCT04668352|EG001|Reported Event|Dactolisib 10mg Once Daily|Dactolisib: TORC1 inhibitor
10821191|NCT00066066|BG002|Baseline|SRP and Amoxicillin, MET and Locally Delivered Tetracycline|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821192|NCT00066066|BG003|Baseline|Total|Total of all reporting groups
10821193|NCT00066066|FG000|Participant Flow|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821194|NCT00066066|FG001|Participant Flow|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821195|NCT00066066|FG002|Participant Flow|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10821196|NCT00066066|FG003|Participant Flow|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10821197|NCT00066066|FG004|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821198|NCT00066066|FG005|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821199|NCT00066066|OG000|Outcome|Scaling and Root Planing Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821200|NCT00066066|OG001|Outcome|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821201|NCT00066066|OG002|Outcome|SRP + Metronidazole NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10821202|NCT00066066|OG003|Outcome|SRP + Metronidazole Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10848181|NCT00289016|BG000|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
10809814|NCT04653766|BG000|Baseline|Ir-CPI - Dose 1|Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
10809815|NCT04653766|BG001|Baseline|Ir-CPI - Dose 2|Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
10809816|NCT04653766|BG002|Baseline|Ir-CPI - Dose 3|Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809817|NCT04653766|BG003|Baseline|Ir-CPI - Dose 4|Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809818|NCT04653766|BG004|Baseline|Placebo|For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
10809819|NCT04653766|BG005|Baseline|Total|Total of all reporting groups
10809820|NCT04653766|FG000|Participant Flow|Ir-CPI - Dose 1|6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
10809821|NCT04653766|FG001|Participant Flow|Ir-CPI - Dose 2|6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
10809822|NCT04653766|FG002|Participant Flow|Ir-CPI - Dose 3|6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809823|NCT04653766|FG003|Participant Flow|Ir-CPI - Dose 4|6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809824|NCT04653766|FG004|Participant Flow|Placebo|For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
10809825|NCT04653766|OG000|Outcome|Ir-CPI - Dose 1|Ir-CPI - Dose 1: 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
10809826|NCT04653766|OG001|Outcome|Ir-CPI - Dose 2|Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
10809827|NCT04653766|OG002|Outcome|Ir-CPI - Dose 3|Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809828|NCT04653766|OG003|Outcome|Ir-CPI - Dose 4|Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809829|NCT04653766|OG004|Outcome|Placebo|Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
10809830|NCT04653766|OG000|Outcome|Ir-CPI - Dose 2|Ir-CPI - Dose 2: 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
10809831|NCT04653766|OG001|Outcome|Ir-CPI - Dose 3|Ir-CPI - Dose 3: 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809832|NCT04653766|OG002|Outcome|Ir-CPI - Dose 4|Ir-CPI - Dose 4: 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809833|NCT04653766|OG003|Outcome|Placebo|Placebo: For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
10809834|NCT04653766|OG000|Outcome|Ir-CPI - Dose 1|Participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
10809835|NCT04653766|OG001|Outcome|Ir-CPI - Dose 2|Participants received a single intravenous dose of 3.0 mg/kg or Ir-CPI during 6 hours
10809836|NCT04653766|OG002|Outcome|Ir-CPI - Dose 3|Participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809837|NCT04653766|OG003|Outcome|Ir-CPI - Dose 4|Participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809838|NCT04653766|OG004|Outcome|Placebo|Participants received a single intravenous dose of placebo during 6 hours
10809839|NCT04653766|EG000|Reported Event|Ir-CPI - Dose 1|6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
10809840|NCT04653766|EG001|Reported Event|Ir-CPI - Dose 2|6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
10809841|NCT04653766|EG002|Reported Event|Ir-CPI - Dose 3|6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
10809842|NCT04653766|EG003|Reported Event|Ir-CPI - Dose 4|6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
10809843|NCT04653766|EG004|Reported Event|Placebo|For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
10809844|NCT04646291|BG000|Baseline|Heterosexual Females With a Male Partner|This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
10809845|NCT04646291|BG001|Baseline|Females in LGBTQ Relationships|"This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809846|NCT04646291|BG002|Baseline|Solo Parent|"This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809847|NCT04646291|BG003|Baseline|Total|Total of all reporting groups
10809848|NCT04646291|FG000|Participant Flow|Heterosexual Females With a Male Partner|"This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809849|NCT04646291|FG001|Participant Flow|Females in LGBTQ Relationships|"This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809850|NCT04646291|FG002|Participant Flow|Solo Parent|"This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809851|NCT04646291|OG000|Outcome|All Participants|The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
10809852|NCT04646291|OG001|Outcome|Heterosexual Females With a Male Partner|This cohort consists of heterosexual females with a male partner who have used the Mosie Baby Kit for insemination during at least one cycle Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
10809853|NCT04646291|OG002|Outcome|Females in LGBTQ Relationships|"This cohort consists of females in LGBTQ Relationships who have used the Mosie Baby Kit for insemination during at least one cycle.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809854|NCT04646291|OG003|Outcome|Solo Parent|"This generally will be a female without a partner who has used the Mosie Baby Kit for insemination during at least one cycle. However, it might also be a male who is using a surrogate female.~Insemination with the Mosie Baby Kit: The participant will have performed at least one cycle of insemination using the Mosie Baby Kit."
10809855|NCT04646291|OG000|Outcome|Pregnancies|This subgroup represents the women who ended up pregnant as a result of using Mosie.
10809856|NCT04646291|OG000|Outcome|All Participants|"The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study.~The information provided includes all 3 arms unless specified."
10809857|NCT04646291|OG000|Outcome|All Participants|The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms.
10809858|NCT04646291|OG000|Outcome|All Pregnant Participants|Reflects only the pregnant participants
10809859|NCT04646291|OG000|Outcome|All Participants|The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study.
10809860|NCT04646291|OG000|Outcome|All Participants|The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms because the focus of this questions is on the impact of COVID without regard for sexual preference.
11244300|NCT02510001|BG000|Baseline|Dose Escalation Phase Dose 1.|"Crizotinib 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10809861|NCT04646291|OG000|Outcome|Pregnancies|This subgroup represents the women who ended up pregnant as a result of using Mosie. The information provided includes all women from all 3 arms because the focus of this questions is on the impact of COVID without regard for sexual preference.
10809862|NCT04646291|EG000|Reported Event|All Participants|The retrospective study examined 350 qualified participants. Females and males, non-binary, and transgender people were included in the study. The information provided includes all 3 arms unless specified.
10821203|NCT00066066|OG004|Outcome|SRP + MET + Amoxicillin + Doxycycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821204|NCT00066066|OG005|Outcome|SRP + MET + Amoxicillin + Doxycycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821205|NCT00066066|EG000|Reported Event|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821206|NCT00066066|EG001|Reported Event|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
10821207|NCT00066066|EG002|Reported Event|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10821208|NCT00066066|EG003|Reported Event|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
10821209|NCT00066066|EG004|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10848182|NCT00289016|FG000|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
10809863|NCT04646109|BG000|Baseline|Control Group|"Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the COVID-19 (SARS-CoV-2 Infection) Guide prepared by the Republic of Turkey Ministry of Health."
10809864|NCT04646109|BG001|Baseline|Study Group|"In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.~Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under Good Manufacturing Practices (GMP) certification conditions."
10809865|NCT04646109|BG002|Baseline|Total|Total of all reporting groups
10809866|NCT04646109|FG000|Participant Flow|Control Group|"Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the COVID-19 (SARS-CoV-2 Infection) Guide prepared by the Republic of Turkey Ministry of Health."
10809867|NCT04646109|FG001|Participant Flow|Study Group|"In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.~Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under Good Manufacturing Practices (GMP) certification conditions."
10809868|NCT04646109|OG000|Outcome|Control Group|"Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the COVID-19 (SARS-CoV-2 Infection) Guide prepared by the Republic of Turkey Ministry of Health."
10809869|NCT04646109|OG001|Outcome|Study Group|"In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.~Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under Good Manufacturing Practices (GMP) certification conditions."
10809870|NCT04646109|EG000|Reported Event|Control Group|"Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the COVID-19 (SARS-CoV-2 Infection) Guide prepared by the Republic of Turkey Ministry of Health."
10809871|NCT04646109|EG001|Reported Event|Study Group|"In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.~Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under Good Manufacturing Practices (GMP) certification conditions."
10809872|NCT04646109|EG002|Reported Event|Participants With Mutations|Patients that were included in the study group and excluded from the study because one or both of the multidrug resistance 1 (MDR1) / ABCB1 and CYP3A4 genes were detected in the blood sample taken at the beginning of ivermectin treatment on the first day
10821210|NCT00066066|EG005|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
10821211|NCT00066170|BG000|Baseline|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821212|NCT00066170|BG001|Baseline|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821213|NCT00066170|BG002|Baseline|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821214|NCT00066170|BG003|Baseline|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821215|NCT00066170|BG004|Baseline|Total|Total of all reporting groups
10821216|NCT00066170|FG000|Participant Flow|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821217|NCT00066170|FG001|Participant Flow|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10809873|NCT04637997|BG000|Baseline|Study Group 1|"Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.~compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity.~compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity."
10809874|NCT04637997|BG001|Baseline|Study Group 2|"Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.~compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity.~compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity."
10809875|NCT04637997|BG002|Baseline|Total|Total of all reporting groups
10809876|NCT04637997|FG000|Participant Flow|Study Group 1|"Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.~compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity.~compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity."
10809877|NCT04637997|FG001|Participant Flow|Study Group 2|"Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.~compression stockings class I: Daily wearing of compression stockings class I for four weeks on the affected extremity.~compression stockings class II: Daily wearing of compression stockings class II for four weeks on the affected extremity."
10809878|NCT04637997|OG000|Outcome|Compression Stockings Class I|Wearing of compression stockings class I on the affected extremity.
10809879|NCT04637997|OG001|Outcome|Compression Stockings Class II|Wearing of compression stockings class II on the affected extremity.
10809880|NCT04637997|OG000|Outcome|Compression Stocking Class I|Daily wearing of compression stockings class I for four weeks on the affected extremity.
10809881|NCT04637997|OG001|Outcome|Compression Stockings Class II|Daily wearing of compression stockings class II for four weeks on the affected extremity.
10809882|NCT04637997|OG000|Outcome|Compression Stockings Class I|Difference between Quality of life after daily wearing of compression stockings class I for four weeks on the affected extremity.
10809883|NCT04637997|OG001|Outcome|Compression Stockings Class II|Difference between Quality of life after daily wearing of compression stockings class II for four weeks on the affected extremity.
10809884|NCT04637997|EG000|Reported Event|Compression Stockings Class I|Wearing of compression stockings class I on the effected extremity for four weeks between Investigation day 28 to 56 or between Investigation day 56 to 84.
10809885|NCT04637997|EG001|Reported Event|Compression Stockings Class II|Wearing of compression stockings class II on the effected extremity for four weeks between Investigation day 28 to 56 or between Investigation day 56 to 84.
10809886|NCT04634903|BG000|Baseline|Supportive Therapy SSI (ST-SSI)|"The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.~Supportive Therapy SSI: Online, 30-minute self-administered program for youth"
10809887|NCT04634903|BG001|Baseline|Behavioral Activation SSI (BA-SSI)|"The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.~Behavioral Activation SSI: Online, 30-minute self-administered program for youth"
10809888|NCT04634903|BG002|Baseline|Growth Mindset SSI (GM-SSI)|"Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used growth mindsets to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.~Growth Mindset SSI: Online, 30-minute self-administered program for youth"
10809889|NCT04634903|BG003|Baseline|Total|Total of all reporting groups
10809890|NCT04634903|FG000|Participant Flow|Supportive Therapy SSI (ST-SSI)|"The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.~Supportive Therapy SSI: Online, 30-minute self-administered program for youth"
10809891|NCT04634903|FG001|Participant Flow|Behavioral Activation SSI (BA-SSI)|"The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.~Behavioral Activation SSI: Online, 30-minute self-administered program for youth"
10809892|NCT04634903|FG002|Participant Flow|Growth Mindset SSI (GM-SSI)|"Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used growth mindsets to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.~Growth Mindset SSI: Online, 30-minute self-administered program for youth"
10809893|NCT04634903|OG000|Outcome|Supportive Therapy SSI (ST-SSI)|"The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.~Supportive Therapy SSI: Online, 30-minute self-administered program for youth"
10809894|NCT04634903|OG001|Outcome|Behavioral Activation SSI (BA-SSI)|"The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.~Behavioral Activation SSI: Online, 30-minute self-administered program for youth"
10809895|NCT04634903|OG002|Outcome|Growth Mindset SSI (GM-SSI)|"Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used growth mindsets to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.~Growth Mindset SSI: Online, 30-minute self-administered program for youth"
10809896|NCT04634903|EG000|Reported Event|Supportive Therapy SSI (ST-SSI)|"The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.~Supportive Therapy SSI: Online, 30-minute self-administered program for youth"
10809897|NCT04634903|EG001|Reported Event|Behavioral Activation SSI (BA-SSI)|"The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.~Behavioral Activation SSI: Online, 30-minute self-administered program for youth"
10809898|NCT04634903|EG002|Reported Event|Growth Mindset SSI (GM-SSI)|"Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used growth mindsets to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.~Growth Mindset SSI: Online, 30-minute self-administered program for youth"
10809899|NCT04633642|BG000|Baseline|Ultrasound Group (UAW Group)|"UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809900|NCT04633642|BG001|Baseline|Surgical Group|"All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.~Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809901|NCT04633642|BG002|Baseline|Total|Total of all reporting groups
10809902|NCT04633642|FG000|Participant Flow|Ultrasound Group (UAW Group)|For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. Every week during 6 weeks
10809903|NCT04633642|FG001|Participant Flow|Surgical Group|Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus. Every week during 6 weeks
10809904|NCT04633642|OG000|Outcome|Ultrasound Group (UAW Group)|"UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809905|NCT04633642|OG001|Outcome|Surgical Group|"All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.~Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809906|NCT04633642|EG000|Reported Event|Ultrasound Group (UAW Group)|"UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809907|NCT04633642|EG001|Reported Event|Surgical Group|"All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.~Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus.~Ultrasound group: For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration."
10809908|NCT04633174|BG000|Baseline|Sous Vide Device|"The intervention will be the use of a sous vide device to heat the water bath to 38oC, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.~Sous Vide Device (SVD): A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable."
10809909|NCT04633174|FG000|Participant Flow|Sous Vide Device|"The intervention will be the use of a sous vide device to heat the water bath to 38oC, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.~Sous Vide Device (SVD): A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable."
10821218|NCT00066170|FG002|Participant Flow|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821219|NCT00066170|FG003|Participant Flow|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821220|NCT00066170|OG000|Outcome|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10809910|NCT04633174|OG000|Outcome|Sous Vide Device|"The intervention will be the use of a sous vide device to heat the water bath to 38oC, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.~Sous Vide Device (SVD): A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable."
10809911|NCT04633174|OG001|Outcome|Manual Water Bath Management|Standard of care for rewarming of Frostbitten Extremities
10809912|NCT04633174|EG000|Reported Event|Sous Vide Device|"The intervention will be the use of a sous vide device to heat the water bath to 38oC, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.~Sous Vide Device (SVD): A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable."
10821221|NCT00066170|OG001|Outcome|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821222|NCT00066170|OG002|Outcome|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821223|NCT00066170|OG003|Outcome|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821224|NCT00066170|EG000|Reported Event|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821225|NCT00066170|EG001|Reported Event|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
10821226|NCT00066170|EG002|Reported Event|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821227|NCT00066170|EG003|Reported Event|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
10821228|NCT00066222|BG000|Baseline|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
10821229|NCT00066222|FG000|Participant Flow|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
10821230|NCT00066222|OG000|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
10821231|NCT00066222|EG000|Reported Event|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
10821232|NCT00066365|BG000|Baseline|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821233|NCT00066365|BG001|Baseline|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821234|NCT00066365|BG002|Baseline|Total|Total of all reporting groups
10847595|NCT00284050|EG000|Reported Event|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10809913|NCT04628221|BG000|Baseline|OsteoProbe System|"OsteoProbe System: The OsteoProbe® System (OsteoProbe) is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation."
10809914|NCT04628221|FG000|Participant Flow|OsteoProbe System|"OsteoProbe System: The OsteoProbe® System (OsteoProbe) is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation."
10809915|NCT04628221|OG000|Outcome|OsteoProbe System|"OsteoProbe System: The OsteoProbe® System (OsteoProbe) is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation."
10809916|NCT04628221|EG000|Reported Event|OsteoProbe System|"OsteoProbe System: The OsteoProbe® System (OsteoProbe) is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation."
10809930|NCT04617509|BG000|Baseline|Overall Trial|All subjects who were included in the study i.e. randomized in Part I GS-248 Formulation A.
10809931|NCT04617509|FG000|Participant Flow|Part I GS-248 Formulation A|"Formulation A given in fasting state.~Formulation A GS-248: Formulation A of GS-248 in a lipid-based size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809932|NCT04617509|FG001|Participant Flow|Part I GS-248 Formulation B|"Formulation B given in fasting state.~Formulation B GS-248: Formulation B of GS-248 in a dry powder size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809933|NCT04617509|FG002|Participant Flow|Part II GS-248 Formulation A in Fed Condition|"Formulation A given in fed condition. Formulation A was selected for the Food Interaction Part of the study, based on the PK profiles of both Formulation A and B.~Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809934|NCT04617509|OG000|Outcome|Part I GS-248 Formulation A|"Formulation A given in fasting state.~Formulation A GS-248: Formulation A of GS-248 in a lipid-based size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809935|NCT04617509|OG001|Outcome|Part I GS-248 Formulation B|"Formulation B given in fasting state.~Formulation B GS-248: Formulation B of GS-248 in a dry powder size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809936|NCT04617509|OG002|Outcome|Part II GS-248 Formulation A in Fed Condition|"Formulation A given in fed condition. Formulation A was selected for the Food Interaction Part of the study, based on the PK profiles of both Formulation A and B.~Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg with breakfast."
10809937|NCT04617509|OG003|Outcome|Part II GS-248 Formulation A in Fasting Condition (Partial Set)|This arm (subject analysis set) was used for a comparison of PK parameters between Formulation A under fed and fasted conditions (namely calculation of the relative bioavailability). The analysis set is part of the Food Interaction PK Analysis Set (PKAS - Food Interaction), and consisted of all subjects in Arm 1 (receiving Formulation A under fasted conditions) who, subsequently, also received Formulation A under fed conditions in the third treatment period of the study (Arm 3). Since 1 subject terminated the study prematurely between study treatment period 1 and 3, only 13 subjects were included in this analysis set that was used for the assessment of the relative bioavailability of Formulation A in fed versus fasted conditions.
10809938|NCT04617509|OG002|Outcome|Part II GS-248 Formulation A in Fed Condition|"Formulation A given in fed condition. Formulation A was selected for the Food Interaction Part of the study, based on the PK profiles of both Formulation A and B.~Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809939|NCT04617509|EG000|Reported Event|Part I GS-248 Formulation A|"Formulation A given in fasting state.~Formulation A GS-248: Formulation A of GS-248 in a lipid-based size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809940|NCT04617509|EG001|Reported Event|Part I GS-248 Formulation B|"Formulation B given in fasting state.~Formulation B GS-248: Formulation B of GS-248 in a dry powder size 1 capsules, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809941|NCT04617509|EG002|Reported Event|Part II GS-248 Formulation A in Fed Condition|"Formulation A given in fed condition. Formulation A was selected for the Food Interaction Part of the study, based on the PK profiles of both Formulation A and B.~Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg."
10809942|NCT04616430|BG000|Baseline|Control|"Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Placebo: topical"
10809943|NCT04616430|BG001|Baseline|Topical Endoxifen 10mg/Breast/Day|"10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809944|NCT04616430|BG002|Baseline|Topical Endoxifen 20mg/Breast/Day|"20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809945|NCT04616430|BG003|Baseline|Total|Total of all reporting groups
10809946|NCT04616430|FG000|Participant Flow|Control|"Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Placebo: topical"
10809947|NCT04616430|FG001|Participant Flow|Topical Endoxifen 10mg/Breast/Day|"10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809948|NCT04616430|FG002|Participant Flow|Topical Endoxifen 20mg/Breast/Day|"20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809949|NCT04616430|OG000|Outcome|Control|"Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Placebo: topical"
10809917|NCT04625426|BG000|Baseline|3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant|"Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).~The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.~3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant"
10809918|NCT04625426|BG001|Baseline|Conveen EasiCleanse and Conveen Critic Barrier|"Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.~Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream"
10809919|NCT04625426|BG002|Baseline|Soap and Water / Incontinence Wipes and Conveen Critic Barrier|"Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.~Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management"
10809920|NCT04625426|BG003|Baseline|Total|Total of all reporting groups
10809921|NCT04625426|FG000|Participant Flow|3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant|"Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).~The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.~3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant"
10809922|NCT04625426|FG001|Participant Flow|Conveen EasiCleanse and Conveen Critic Barrier|"Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.~Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream"
10809923|NCT04625426|FG002|Participant Flow|Soap and Water / Incontinence Wipes and Conveen Critic Barrier|"Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.~Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management"
10809924|NCT04625426|OG000|Outcome|3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant|"Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).~The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.~3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant"
10809925|NCT04625426|OG001|Outcome|Conveen EasiCleanse and Conveen Critic Barrier|"Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.~Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream"
10809926|NCT04625426|OG002|Outcome|Soap and Water / Incontinence Wipes and Conveen Critic Barrier|"Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.~Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management"
10809927|NCT04625426|EG000|Reported Event|3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant|"Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer).~The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.~3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant: Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant"
10809928|NCT04625426|EG001|Reported Event|Conveen EasiCleanse and Conveen Critic Barrier|"Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.~Conveen EasiCleanse and Conveen Critic Barrier: Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream"
10809929|NCT04625426|EG002|Reported Event|Soap and Water / Incontinence Wipes and Conveen Critic Barrier|"Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.~Standard cleansing and Conveen Critic Barrier: Hospital's standard care for IAD management"
10809950|NCT04616430|OG001|Outcome|Topical Endoxifen 10mg/Breast/Day|"10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809951|NCT04616430|OG002|Outcome|Topical Endoxifen 20mg/Breast/Day|"20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809952|NCT04616430|EG000|Reported Event|Control|"Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Placebo: topical"
10809953|NCT04616430|EG001|Reported Event|Topical Endoxifen 10mg/Breast/Day|"10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10809954|NCT04616430|EG002|Reported Event|Topical Endoxifen 20mg/Breast/Day|"20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil~Topical endoxifen: topical solution"
10821235|NCT00066365|FG000|Participant Flow|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821236|NCT00066365|FG001|Participant Flow|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821237|NCT00066365|OG000|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821238|NCT00066365|OG001|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821239|NCT00066365|OG001|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms~conventional surgery: thoracotomy"
10821240|NCT00066365|OG000|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
10821241|NCT00066365|EG000|Reported Event|Group 1 (Unilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
10821242|NCT00066365|EG001|Reported Event|Group 2 (Bilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
10821243|NCT00066469|BG000|Baseline|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
10821244|NCT00066469|FG000|Participant Flow|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
10809955|NCT04615507|BG000|Baseline|Test/Control/Control|Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods.
10809956|NCT04615507|BG001|Baseline|Control/Test/Test|Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.
10809957|NCT04615507|BG002|Baseline|Total|Total of all reporting groups
10809958|NCT04615507|FG000|Participant Flow|Test/Control/Control|Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods.
10809959|NCT04615507|FG001|Participant Flow|Control/Test/Test|Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.
10809960|NCT04615507|OG000|Outcome|Test|All subjects that wore the Test lens during any of the 3 study periods.
10809961|NCT04615507|OG001|Outcome|Control|All subjects that wore the Control lens during any of the 3 study periods.
10809962|NCT04615507|EG000|Reported Event|Test|All subjects that wore the Test lens during any of the 3 study periods.
10809963|NCT04615507|EG001|Reported Event|Control|All subjects that wore the Control lens during any of the 3 study periods.
10821245|NCT00066469|OG000|Outcome|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
10821246|NCT00066469|EG000|Reported Event|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
10821247|NCT00066573|BG000|Baseline|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
10821248|NCT00066573|BG001|Baseline|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
10821249|NCT00066573|BG002|Baseline|Total|Total of all reporting groups
10821250|NCT00066573|FG000|Participant Flow|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
10821251|NCT00066573|FG001|Participant Flow|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
10821252|NCT00066573|OG000|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
10821253|NCT00066573|OG001|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
10821254|NCT00066573|EG000|Reported Event|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
10821255|NCT00066573|EG001|Reported Event|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
10821256|NCT00066677|BG000|Baseline|rhuMAB-VEGF|rhuMAB-VEGF :
10821257|NCT00066677|BG001|Baseline|rhuMAB-VEGF and Docetaxel|"rhuMAB-VEGF :~docetaxel :"
10821258|NCT00066677|BG002|Baseline|Total|Total of all reporting groups
10821259|NCT00066677|FG000|Participant Flow|rhuMAB-VEGF|rhuMAB-VEGF :
10821260|NCT00066677|FG001|Participant Flow|rhuMAB-VEGF and Docetaxel|"rhuMAB-VEGF :~docetaxel :"
10821261|NCT00066677|OG000|Outcome|rhuMAB-VEGF|rhuMAB-VEGF :
10821262|NCT00066677|OG001|Outcome|rhuMAB-VEGF and Docetaxel|"rhuMAB-VEGF :~docetaxel :"
10821263|NCT00066677|EG000|Reported Event|rhuMAB-VEGF|rhuMAB-VEGF :
10821264|NCT00066677|EG001|Reported Event|rhuMAB-VEGF and Docetaxel|"rhuMAB-VEGF :~docetaxel :"
10821265|NCT00066690|BG000|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10821266|NCT00066690|BG001|Baseline|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821267|NCT00066690|BG002|Baseline|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821268|NCT00066690|BG003|Baseline|Total|Total of all reporting groups
10821269|NCT00066690|FG000|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10821270|NCT00066690|FG001|Participant Flow|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821271|NCT00066690|FG002|Participant Flow|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821272|NCT00066690|OG000|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10821273|NCT00066690|OG001|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821274|NCT00066690|OG002|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821275|NCT00066690|OG000|Outcome|Tamoxifen|"Tamoxifen 20mg orally daily for 5 years~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Tamoxifen: Tamoxifen 20mg orally daily for 5 years"
10821276|NCT00066690|OG001|Outcome|T+OFS|"Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Laboratory Biomarker Analysis: Correlative studies~Oophorectomy: Undergo bilateral surgical oophorectomy~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo ovarian irradiation~Tamoxifen: Tamoxifen 20mg orally daily for 5 years~Triptorelin: 3.75 mg by im injection q28 days for 5 years"
10809964|NCT04610489|BG000|Baseline|Study Population|All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
11205564|NCT02229539|BG001|Baseline|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205565|NCT02229539|BG002|Baseline|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205566|NCT02229539|BG003|Baseline|Total|Total of all reporting groups
11205567|NCT02229539|FG000|Participant Flow|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205568|NCT02229539|FG001|Participant Flow|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205569|NCT02229539|FG002|Participant Flow|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205570|NCT02229539|OG000|Outcome|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205571|NCT02229539|OG001|Outcome|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205572|NCT02229539|OG002|Outcome|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205573|NCT02229539|EG000|Reported Event|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205574|NCT02229539|EG001|Reported Event|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205575|NCT02229539|EG002|Reported Event|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
11205576|NCT02229552|BG000|Baseline|Baseline Cohort|All children completed measures of habituation to food, questionnaires and cognitive assessments at baseline and 1-year and 2-year follow up periods.
11205577|NCT02229552|FG000|Participant Flow|Baseline Cohort|All children completed the same baseline measures
11205578|NCT02229552|OG000|Outcome|Baseline Cohort|All children completed the same baseline measures
11205579|NCT02229552|EG000|Reported Event|Baseline Cohort|All children completed the same baseline measures
11205580|NCT02229851|BG000|Baseline|Placebo|Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205581|NCT02229851|BG001|Baseline|Norditropin|"Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.~Participants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial."
11205582|NCT02229851|BG002|Baseline|Somapacitan|Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205583|NCT02229851|BG003|Baseline|Total|Total of all reporting groups
11205584|NCT02229851|FG000|Participant Flow|Placebo|Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205585|NCT02229851|FG001|Participant Flow|Norditropin|Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205586|NCT02229851|FG002|Participant Flow|Somapacitan|Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205587|NCT02229851|FG003|Participant Flow|Placebo/Somapacitan|Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205588|NCT02229851|FG004|Participant Flow|Somapacitan/Somapacitan|Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205589|NCT02229851|FG005|Participant Flow|Norditropin/Norditropin|Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205590|NCT02229851|FG006|Participant Flow|Norditropin/Somapacitan|Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205591|NCT02229851|OG000|Outcome|Placebo|Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
10809965|NCT04610489|FG000|Participant Flow|Study Population|All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
10809966|NCT04610489|OG000|Outcome|Study Population|All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
10809967|NCT04610489|OG000|Outcome|Study Population|All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. No other baseline characteristics were collected.
10809968|NCT04610489|EG000|Reported Event|Study Population|All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR) via nasopharyngeal swab.
10821277|NCT00066690|OG002|Outcome|E+OFS|"Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression~Laboratory Biomarker Analysis: Correlative studies~Oophorectomy: Undergo bilateral surgical oophorectomy~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo ovarian irradiation~Triptorelin: 3.75 mg by im injection q28 days for 5 years"
10821278|NCT00066690|EG000|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
10821279|NCT00066690|EG001|Reported Event|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
11205592|NCT02229851|OG001|Outcome|Norditropin|Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205593|NCT02229851|OG002|Outcome|Somapacitan|Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205594|NCT02229851|OG000|Outcome|Placebo/Somapacitan|Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205595|NCT02229851|OG001|Outcome|Somapacitan/Somapacitan|Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205596|NCT02229851|OG002|Outcome|Norditropin/Norditropin|Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
11205597|NCT02229851|OG003|Outcome|Norditropin/Somapacitan|Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
10821280|NCT00066690|EG002|Reported Event|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
10821281|NCT00066703|BG000|Baseline|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821282|NCT00066703|BG001|Baseline|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821283|NCT00066703|BG002|Baseline|Total|Total of all reporting groups
11205598|NCT02229851|OG004|Outcome|Norditropin/-|Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
11205599|NCT02229851|EG000|Reported Event|Placebo - Main Phase|Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205600|NCT02229851|EG001|Reported Event|Somapacitan - Main Phase|Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205601|NCT02229851|EG002|Reported Event|Norditropin - Main Phase|Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
11205602|NCT02229851|EG003|Reported Event|Somapacitan - Extension Phase|The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
11205603|NCT02229851|EG004|Reported Event|Norditropin- Extension Phase|The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
10809969|NCT04608500|BG000|Baseline|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
10809970|NCT04608500|BG001|Baseline|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
10809971|NCT04608500|BG002|Baseline|Total|Total of all reporting groups
10809972|NCT04608500|FG000|Participant Flow|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
10809973|NCT04608500|FG001|Participant Flow|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
10809974|NCT04608500|OG000|Outcome|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
10809975|NCT04608500|OG001|Outcome|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
10809976|NCT04608500|EG000|Reported Event|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
10809977|NCT04608500|EG001|Reported Event|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
10809978|NCT04607291|BG000|Baseline|Health Services Research (Witness CARES Services) Intervention|"Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.~Community Health Service: Receive Witness CARES services~Survey Administration: Ancillary studies"
10809979|NCT04607291|FG000|Participant Flow|Health Services Research (Witness CARES Services) Intervention|"Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.~Community Health Service: Receive Witness CARES services~Survey Administration: Ancillary studies"
10809980|NCT04607291|OG000|Outcome|Health Services Research (Witness CARES Services) Intervention|"Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.~Community Health Service: Receive Witness CARES services~Survey Administration: Ancillary studies"
10809981|NCT04607291|EG000|Reported Event|Health Services Research (Witness CARES Services) Intervention|"Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.~Community Health Service: Receive Witness CARES services~Survey Administration: Ancillary studies"
10809991|NCT04599959|BG000|Baseline|Overall|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.~Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico."
10809992|NCT04599959|FG000|Participant Flow|Overall|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.~Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico."
10809993|NCT04599959|OG000|Outcome|Swab - Processed in Mexico|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.~Participants whose swab samples were processed in Mexico and had non-missing results were included in this group."
10809994|NCT04599959|OG001|Outcome|Saliva - Processed in Mexico|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.~Participants whose saliva samples collected via Salivette® Cortisol were processed in Mexico and had non-missing results were included in this group."
10809995|NCT04599959|OG000|Outcome|Swab+Saliva - Processed in Germany|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.~Participants with both swab and saliva samples and whose samples were processed in Germany and had non-missing results were included in this group."
10821284|NCT00066703|FG000|Participant Flow|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10809982|NCT04605588|BG000|Baseline|Active Study Drug|"5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate~Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809983|NCT04605588|BG001|Baseline|Placebo|"5 day dosing of placebo~Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809984|NCT04605588|BG002|Baseline|Total|Total of all reporting groups
10809985|NCT04605588|FG000|Participant Flow|Active Study Drug|"5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate~Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809986|NCT04605588|FG001|Participant Flow|Placebo|"5 day dosing of placebo~Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809987|NCT04605588|OG000|Outcome|Active Study Drug|"5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate~Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809988|NCT04605588|OG001|Outcome|Placebo|"5 day dosing of placebo~Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809989|NCT04605588|EG000|Reported Event|Active Study Drug|"5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate~Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809990|NCT04605588|EG001|Reported Event|Placebo|"5 day dosing of placebo~Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)~Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)~Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)"
10809996|NCT04599959|EG000|Reported Event|Overall|"All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.~Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.~Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico."
10821285|NCT00066703|FG001|Participant Flow|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821286|NCT00066703|OG000|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821287|NCT00066703|OG001|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821288|NCT00066703|EG000|Reported Event|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821289|NCT00066703|EG001|Reported Event|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
10821290|NCT00066729|BG000|Baseline|NY-ESO-1b Peptide With Montanide® ISA-51|Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
10821291|NCT00066729|FG000|Participant Flow|NY-ESO-1b Peptide With Montanide® ISA-51|Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
10821292|NCT00066729|OG000|Outcome|NY-ESO-1b Peptide With Montanide® ISA-51|Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
10821293|NCT00066729|EG000|Reported Event|NY-ESO-1b Peptide With Montanide® ISA-51|Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
10821294|NCT00066742|BG000|Baseline|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
10821295|NCT00066742|FG000|Participant Flow|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
10821296|NCT00066742|OG000|Outcome|Evaluable Patients|
10809997|NCT04596085|BG000|Baseline|Investigational Product|"Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy~Investigational Product - ViraCide: Viracide"
10809998|NCT04596085|BG001|Baseline|Placebo|"Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy~Placebo - Starch Powder Soft gels: Starch Powder Soft gels"
10809999|NCT04596085|BG002|Baseline|Total|Total of all reporting groups
10810000|NCT04596085|FG000|Participant Flow|Investigational Product|"Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy~Investigational Product - ViraCide: Viracide"
10810001|NCT04596085|FG001|Participant Flow|Placebo|"Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy~Placebo - Starch Powder Soft gels: Starch Powder Soft gels"
10810002|NCT04596085|OG000|Outcome|Investigational Product|Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .
10810003|NCT04596085|OG001|Outcome|Placebo|Ingredient, Placebo Ingredient Starch softgels.
10810004|NCT04596085|OG000|Outcome|Investigational Product|Experimental, Investigational Product Ingredient : ViraCide softgels . Frequency: 3 soft gels, two times every day after breakfast and dinner.
10810005|NCT04596085|OG001|Outcome|Placebo|Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times every day after breakfast and dinner.
10810006|NCT04596085|EG000|Reported Event|Investigational Product|Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .
10810007|NCT04596085|EG001|Reported Event|Placebo|Ingredient, Placebo Ingredient Starch softgels.
10810008|NCT04590027|BG000|Baseline|Caudal Block (CB)|"Caudal Block (CB)~pain management~1 ml kg-1 ropivacaine and clonidine 2 ug kg-1"
10810009|NCT04590027|BG001|Baseline|Local Infiltration (LI)|Local Infiltration (LI) pain management 0.375% 0.5 ml kg-1 ropivacaine injected subcutaneously
10810010|NCT04590027|BG002|Baseline|Total|Total of all reporting groups
10810011|NCT04590027|FG000|Participant Flow|Caudal Block|Caudal anaesthesia was performed after induction of anaesthesia. The puncture site was preoperatively anesthetized with Eutetic Mixture of Local Anaesthetics (EMLA®). The patient was then placed in a lateral decubitus position with left side down. An Epican® Paed 23G Tuohy needle was inserted into the epidural space using anatomical landmarks. After negative aspiration, a combination of a local anaesthetic (1 ml kg-1 ropivacaine 0,2%) and clonidine (2 μg kg-1) was applied.
10810012|NCT04590027|FG001|Participant Flow|Local Infiltration (LI)|In patients randomised to the Local Infiltration group (LI) ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
11205604|NCT02229864|BG000|Baseline|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
10810013|NCT04590027|OG000|Outcome|Caudal Block|Ropivacaine 0,2 % 1 ml kg-1 and clonidine 2 μg kg-1
10810014|NCT04590027|OG001|Outcome|Local Infiltration|Ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously
10810015|NCT04590027|OG000|Outcome|Caudal Block|Ropivacaine 0,2% 1ml kg-1 and clonidine 2µg kg-1
10810016|NCT04590027|OG001|Outcome|Local Infiltration|Ropivacaine 0.375% 0.5 ml kg-1 subcutaneously
10810017|NCT04590027|OG000|Outcome|Caudal Block|ropivacaine 0,2% 1 ml kg-1 and clonidine 2 μg kg-1
10810018|NCT04590027|OG001|Outcome|Local Infiltration|Ropivacaine 0.375% 0.5 ml kg-1
10810019|NCT04590027|EG000|Reported Event|Caudal Block|Caudal anaesthesia was performed after induction of anaesthesia. The puncture site was preoperatively anesthetized with EMLA®. The patient was then placed in a lateral decubitus position with left side down. An Epican® Paed 23G Tuohy needle was inserted into the epidural space using anatomical landmarks. After negative aspiration, a combination of a local anaesthetic (1 ml kg-1 ropivacaine 0,2%) and clonidine (2 μg kg-1) was applied.
10810020|NCT04590027|EG001|Reported Event|Local Infiltration|In patients randomised to the LI group ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
10810021|NCT04578457|BG000|Baseline|Study Cohort|"This study was a crossover design, therefore there was only a single study group.~This group undertook measures under each of the study conditions."
10810022|NCT04578457|FG000|Participant Flow|Randomized Condition|"This was a crossover within subject design study in which all participants undertook all study conditions.~These conditions consisted of different hearing aid settings, and were interleaved within study appointments.~Accordingly, the different conditions are reported here as study 'Periods' to avoid participants being included multiple times in the overall protocol count.~This means there will be a discrepancy whereby the number starting a period will be greater than the number completing the previous 'period'. Of course this is simply due to the fact that the study 'periods' as reported are not chronological."
10810023|NCT04578457|OG000|Outcome|Hearing Aid Without NR(0) Enabled|"Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.~Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active."
10810024|NCT04578457|OG001|Outcome|Hearing Aid With NR (1)|"Hearing Aid with Noise Reduction I (NR) enabled.~Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort."
10810025|NCT04578457|OG002|Outcome|Hearing Aid With NR(2)|"Hearing Aid with Noise Reduction II (NR) enabled.~Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1)."
10810026|NCT04578457|OG003|Outcome|Hearing Aid With NR(3)|"Hearing Aid with Noise Reduction III (NR) enabled.~Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2)."
10810027|NCT04578457|OG000|Outcome|Study Cohort|"This was a measure of underlying auditory function. Accordingly it was made without the use of hearing aids (i.e. under a single unaided condition).~Therefore, the results are reported as a single group."
10810028|NCT04578457|EG000|Reported Event|Study Cohort|"This study was a crossover design, therefore there was only a single study group.~This group undertook measures under each of the study conditions. These conditions were undertaken in an interleaved fashion during the same study appointment.~As such it is not possible to attribute the adverse event reported to any single condition.~We therefore report the adverse events here as a function of the entire study population."
10810029|NCT04578496|BG000|Baseline|Afamelanotide|
10810030|NCT04578496|FG000|Participant Flow|Afamelanotide|
10810031|NCT04578496|OG000|Outcome|Afamelanotide|
10810032|NCT04578496|EG000|Reported Event|Afamelanotide|
10821297|NCT00066742|OG000|Outcome|Evaluable Patients With Measurable Disease|Only eligible patients who received protocol treatment and who had measurable lesions (per RECIST) at baseline were included in this analysis.
10821298|NCT00066742|EG000|Reported Event|Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy|
10821299|NCT00066742|EG001|Reported Event|Consolidation Cisplatin + Etoposide|
10821300|NCT00066781|BG000|Baseline|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10821301|NCT00066781|BG001|Baseline|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10821302|NCT00066781|BG002|Baseline|Total|Total of all reporting groups
10821303|NCT00066781|FG000|Participant Flow|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10821304|NCT00066781|FG001|Participant Flow|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10821305|NCT00066781|OG000|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10821306|NCT00066781|OG001|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10821307|NCT00066781|EG000|Reported Event|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
10821308|NCT00066781|EG001|Reported Event|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
10821309|NCT00066937|BG000|Baseline|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
10821310|NCT00066937|BG001|Baseline|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
10821311|NCT00066937|BG002|Baseline|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
10821312|NCT00066937|BG003|Baseline|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
10821313|NCT00066937|BG004|Baseline|Total|Total of all reporting groups
10821314|NCT00066937|FG000|Participant Flow|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
10821315|NCT00066937|FG001|Participant Flow|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
10821316|NCT00066937|FG002|Participant Flow|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
10821317|NCT00066937|FG003|Participant Flow|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
10821318|NCT00066937|OG000|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
10821319|NCT00066937|OG001|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
10821320|NCT00066937|OG002|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
10821321|NCT00066937|OG003|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
10821322|NCT00066937|EG000|Reported Event|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
10821323|NCT00066937|EG001|Reported Event|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
10821324|NCT00066937|EG002|Reported Event|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
10810033|NCT04577183|BG000|Baseline|RD1 System|"The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.~RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings."
10810034|NCT04577183|FG000|Participant Flow|RD1 System|"The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.~RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings."
10810035|NCT04577183|OG000|Outcome|RD1 System|"The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.~RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings."
10810036|NCT04577183|EG000|Reported Event|RD1 System|"The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.~RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings."
10821325|NCT00066937|EG003|Reported Event|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
10821326|NCT00067002|BG000|Baseline|Un-Manipulated CB Arm|Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3.
10821327|NCT00067002|BG001|Baseline|Expanded CB Arm|Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy.
10821328|NCT00067002|BG002|Baseline|Total|Total of all reporting groups
10821329|NCT00067002|FG000|Participant Flow|Double Cord Blood Transplant Group (Un-Manipulated)|"Transplantation of Two Unmanipulated Cord Blood (CB) units. Rituxan 375 mg/m2 by vein (IV) Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3.~Expanded allogeneic cord blood (CB): Transplantation of Two Unmanipulated Cord Blood Units."
10821330|NCT00067002|FG001|Participant Flow|One Expanded Cord Blood Transplant Group (Expanded)|One Unmanipulated and One Expanded Cord Blood Unit. Rituxan: 375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Cyclophosphamide 50 mg/kg by vein on Day -6. Mesna 10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). Total body irradiation (TBI) given on Day -1 at 2 Gy.
10821331|NCT00067002|OG000|Outcome|Un-Manipulated CB Arm|Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3.
10821332|NCT00067002|OG001|Outcome|Expanded CB Arm|Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy.
10821333|NCT00067002|EG000|Reported Event|Un-Manipulated CB Arm|Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3.
10810037|NCT04574999|BG000|Baseline|0.005% Estriol Group|"0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Estriol: Gel for vaginal application"
10810038|NCT04574999|BG001|Baseline|Placebo Group|"Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Placebo: Gel for vaginal application"
10810039|NCT04574999|BG002|Baseline|Total|Total of all reporting groups
10810040|NCT04574999|FG000|Participant Flow|0.005% Estriol Group|"0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Estriol: Gel for vaginal application"
10810041|NCT04574999|FG001|Participant Flow|Placebo Group|"Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Placebo: Gel for vaginal application"
10810042|NCT04574999|OG000|Outcome|0.005% Estriol Group|"0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Estriol: Gel for vaginal application"
10810043|NCT04574999|OG001|Outcome|Placebo Group|"Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Placebo: Gel for vaginal application"
10810044|NCT04574999|EG000|Reported Event|0.005% Estriol Group|"0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Estriol: Gel for vaginal application"
10810045|NCT04574999|EG001|Reported Event|Placebo Group|"Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.~Placebo: Gel for vaginal application"
10821334|NCT00067002|EG001|Reported Event|Expanded CB Arm|Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy.
10821335|NCT00067028|BG000|Baseline|Clofarabine + Ara-C|"Clofarabine 40 mg/m^2 by vein over 1 hour daily for 5 days.~Ara-C : 1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821336|NCT00067028|BG001|Baseline|Clofarabine + Idarubicin|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
10821337|NCT00067028|BG002|Baseline|Clofarabine + Idarubicin + Ara-C|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Ara-C Starting dose: 0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821338|NCT00067028|BG003|Baseline|Total|Total of all reporting groups
10821339|NCT00067028|FG000|Participant Flow|Clofarabine + Ara-C|"Clofarabine 40 mg/m^2 by vein over 1 hour daily for 5 days.~Ara-C :1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821340|NCT00067028|FG001|Participant Flow|Clofarabine + Idarubicin|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
10821341|NCT00067028|FG002|Participant Flow|Clofarabine + Idarubicin + Ara-C|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Ara-C Starting dose: 0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821342|NCT00067028|OG000|Outcome|Clofarabine + Ara-C|"Clofarabine 40 mg/m^2 by vein over 1 hour daily for 5 days.~Ara-C : 1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821343|NCT00067028|OG001|Outcome|Clofarabine + Idarubicin|"Clofarabine 30 - 40 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
10821344|NCT00067028|OG002|Outcome|Clofarabine + Idarubicin + Ara-C|"Clofarabine 30 - 40 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Ara-C Starting dose: 0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821345|NCT00067028|OG001|Outcome|Clofarabine + Idarubicin|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
10821346|NCT00067028|OG002|Outcome|Clofarabine + Idarubicin + Ara-C|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Ara-C Starting dose: 0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821347|NCT00067028|EG000|Reported Event|Clofarabine + Ara-C|"Clofarabine 40 mg/m^2 by vein over 1 hour daily for 5 days.~Ara-C :1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821348|NCT00067028|EG001|Reported Event|Clofarabine + Idarubicin|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
10821349|NCT00067028|EG002|Reported Event|Clofarabine + Idarubicin + Ara-C|"Clofarabine 22.5 mg/m^2 by vein over 1 hour daily for 5 days.~Idarubicin 6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Ara-C Starting dose: 0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle."
10821350|NCT00067236|BG000|Baseline|Placebo|Placebo tablet twice daily for 90 days
10821351|NCT00067236|BG001|Baseline|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
10810046|NCT04572997|BG000|Baseline|Full Analysis Set (FAS)|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
10810047|NCT04572997|FG000|Participant Flow|Full Analysis Set (FAS)|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.~Apremilast was taken orally twice daily (except Day 1). During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day."
10810048|NCT04572997|OG000|Outcome|Full Analysis Set (FAS)|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
10810049|NCT04572997|OG001|Outcome|Per Protocol Set (PPS)|The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
10810050|NCT04572997|OG002|Outcome|Full Analysis Set - LOCF|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
10810051|NCT04572997|OG000|Outcome|Full Analysis Set - LOCF|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
10810052|NCT04572997|OG000|Outcome|Per Protocol Set (PPS)|The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
10810053|NCT04572997|EG000|Reported Event|Full Analysis Set (FAS)|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
10810054|NCT04563767|BG000|Baseline|Infinitome|"All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.~Infinitome: Added sequence of rs-fMRI."
10810055|NCT04563767|FG000|Participant Flow|Infinitome|"All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.~Infinitome: Added sequence of rs-fMRI."
10810056|NCT04563767|OG000|Outcome|Infinitome|"All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.~Infinitome: Added sequence of rs-fMRI."
10810057|NCT04563767|EG000|Reported Event|Infinitome|"All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.~Infinitome: Added sequence of rs-fMRI."
10810069|NCT04555525|BG000|Baseline|Sarecycline|"weight-based dose per label by mouth once daily for 12 weeks~sarecycline: sarecycline tablet"
10810070|NCT04555525|BG001|Baseline|Centrum Adult Multivitamin|"one tablet by mouth daily for 12 weeks~Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet"
10810071|NCT04555525|BG002|Baseline|Total|Total of all reporting groups
10810072|NCT04555525|FG000|Participant Flow|Sarecycline|"weight-based dose per label by mouth once daily for 12 weeks~sarecycline: sarecycline tablet"
10810073|NCT04555525|FG001|Participant Flow|Centrum Adult Multivitamin|"one tablet by mouth daily for 12 weeks~Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet"
10810074|NCT04555525|OG000|Outcome|Sarecycline|"weight-based dose per label by mouth once daily for 12 weeks~sarecycline: sarecycline tablet"
10810075|NCT04555525|OG001|Outcome|Centrum Adult Multivitamin|"one tablet by mouth daily for 12 weeks~Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet"
10810076|NCT04555525|EG000|Reported Event|Sarecycline|"weight-based dose per label by mouth once daily for 12 weeks~sarecycline: sarecycline tablet"
10810077|NCT04555525|EG001|Reported Event|Centrum Adult Multivitamin|"one tablet by mouth daily for 12 weeks~Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet"
10821352|NCT00067236|BG002|Baseline|Total|Total of all reporting groups
10821353|NCT00067236|FG000|Participant Flow|Placebo|Placebo tablet twice daily for 90 days
10821354|NCT00067236|FG001|Participant Flow|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
10821355|NCT00067236|OG000|Outcome|Placebo|Placebo tablet twice daily for 90 days
10821356|NCT00067236|OG001|Outcome|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
10821357|NCT00067236|EG000|Reported Event|Placebo|Placebo tablet twice daily for 90 days
10821358|NCT00067236|EG001|Reported Event|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
10821359|NCT00067470|BG000|Baseline|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
10821360|NCT00067470|BG001|Baseline|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
10821361|NCT00067470|BG002|Baseline|Total|Total of all reporting groups
10821362|NCT00067470|FG000|Participant Flow|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
10821363|NCT00067470|FG001|Participant Flow|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
10821364|NCT00067470|OG000|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
10821365|NCT00067470|OG001|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
10821366|NCT00067470|EG000|Reported Event|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
10821367|NCT00067470|EG001|Reported Event|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
10821368|NCT00067808|BG000|Baseline|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
10821369|NCT00067808|BG001|Baseline|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
11205605|NCT02229864|FG000|Participant Flow|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
10810058|NCT04560374|BG000|Baseline|Experimental Group|All neonates who was delivered to the hands crochet octopus during data collection process
10810059|NCT04560374|BG001|Baseline|Control Group|All neonates who was not delivered to the hands crochet octopus during data collection process
10810060|NCT04560374|BG002|Baseline|Total|Total of all reporting groups
10810061|NCT04560374|FG000|Participant Flow|Experimental Group|Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
10810062|NCT04560374|FG001|Participant Flow|Control Group|Control group neonates were performed all the process without delivering them any crochet octopus.
10810063|NCT04560374|OG000|Outcome|Experimental Group|Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
10810064|NCT04560374|OG001|Outcome|Control Group|Control group neonates were performed all the process without delivering them any crochet octopus.
10810065|NCT04560374|OG000|Outcome|Experimental Group|All neonates who was delivered to the hands crochet octopus during data collection process
10810066|NCT04560374|OG001|Outcome|Control Group|All neonates who was not delivered to the hands crochet octopus during data collection process
11205606|NCT02229864|OG000|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
11205607|NCT02229864|EG000|Reported Event|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
11205608|NCT02230085|BG000|Baseline|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
11205609|NCT02230085|FG000|Participant Flow|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
11205610|NCT02230085|OG000|Outcome|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
11205611|NCT02230085|EG000|Reported Event|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
10810067|NCT04560374|EG000|Reported Event|Experimental Group|Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
10810068|NCT04560374|EG001|Reported Event|Control Group|Control group neonates were performed all the process without delivering them any crochet octopus.
10810078|NCT04553497|BG000|Baseline|Rehabilitation and Interferential Current Therapy|"In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program. Interferential current: were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program: Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands"
10810079|NCT04553497|BG001|Baseline|Rehabilitation and Sham Interferential Current Therapy|"In this arm, sham interferential current therapy was applied to the patients in addition to the rehabilitation program.~Sham interferential current were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes.~Rehabilitation program: Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810080|NCT04553497|BG002|Baseline|Total|Total of all reporting groups
10810081|NCT04553497|FG000|Participant Flow|Rehabilitation and Sham Interferential Current Therapy|"Flipping a coin was used for simple randomization (heads - sham). In this arm, sahm interferential current therapy was applied to the patients in addition to the rehabilitation program.~Sham interferential current was applied to the patients before each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. The sham interferential current therapy consisted of the placement but no electrical stimulation was applied to the probes. Rehabilitation program was performed to all patients."
10810082|NCT04553497|FG001|Participant Flow|Rehabilitation and Interferential Current Therapy|"Flipping a coin was used for simple randomization (tails - interferential current). In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.~Interferential current: Interferential current was applied to the patients before each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program was performed to all patients"
10821370|NCT00067808|BG002|Baseline|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
10821371|NCT00067808|BG003|Baseline|Total|Total of all reporting groups
10821372|NCT00067808|FG000|Participant Flow|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
10821373|NCT00067808|FG001|Participant Flow|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
10810083|NCT04553497|OG000|Outcome|Rehabilitation and Interferential Current Therapy|"In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.~Interferential current were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks.At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810084|NCT04553497|OG001|Outcome|Rehabilitation and Sham Interferential Current Therapy|"Sham interferential current therapy was applied to the patients in addition to the rehabilitation program.~Sham interferential current were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810085|NCT04553497|OG000|Outcome|Rehabilitation and Interferential Current Therapy|"In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.~Interferential current were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810086|NCT04553497|OG000|Outcome|Rehabilitation and Interferential Current Therapy|"In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.~Interferential current or sham were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810087|NCT04553497|OG001|Outcome|Rehabilitation and Sham Interferential Current Therapy|"Sham interferential current therapy was applied to the patients in addition to the rehabilitation program.~Sham interferential currentwere applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810088|NCT04553497|EG000|Reported Event|Rehabilitation and Interferential Current Therapy|"In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.~Interferential current was applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10810089|NCT04553497|EG001|Reported Event|Rehabilitation and Sham Interferential Current Therapy|"Sham interferential current therapy was applied to the patients in addition to the rehabilitation program.~Sham interferential current was applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes.~Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands."
10821374|NCT00067808|FG002|Participant Flow|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
10821375|NCT00067808|OG000|Outcome|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
11205612|NCT02230306|BG000|Baseline|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
11205613|NCT02230306|FG000|Participant Flow|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
11205614|NCT02230306|OG000|Outcome|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
10810090|NCT04548622|BG000|Baseline|Non-randomized Bilateral rTMS|"Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus~Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption."
10810091|NCT04548622|FG000|Participant Flow|Non-randomized Bilateral rTMS|"Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus~Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption."
10810092|NCT04548622|OG000|Outcome|Non-randomized Bilateral rTMS|"Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus~Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption."
10810093|NCT04548622|EG000|Reported Event|Non-randomized Bilateral rTMS|"Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus~Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption."
10810094|NCT04547036|BG000|Baseline|XEN45 Implantation With and Without Combined Cataract Surgery|Eyes with a history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination.
10810095|NCT04547036|FG000|Participant Flow|XEN45 Implantation With and Without Combined Cataract Surgery|Patients with history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination
10810096|NCT04547036|OG000|Outcome|Endothelial Cell Count Measurment|XEN45: Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.
10810097|NCT04547036|EG000|Reported Event|XEN45 Implantation With and Without Combined Cataract Surgery|Patients with history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination
10810098|NCT04544566|BG000|Baseline|Test Tape A, Test Tape B, and Then Comparator Tape|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810099|NCT04544566|BG001|Baseline|Test Tape A, Comparator Tape and Then Test Tape B|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
11205615|NCT02230306|EG000|Reported Event|Cobimetinib in Combination With Vemurafenib|Vemurafenib (960 mg twice a day) taken on Days 1 - 28 of each 28-day treatment cycle. Cobimetinib (60 mg once a day) taken on Days 1 - 21 of each 28-day treatment cycle.
10821376|NCT00067808|OG001|Outcome|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
10821377|NCT00067808|OG002|Outcome|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
10821378|NCT00067808|EG000|Reported Event|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
10821379|NCT00067808|EG001|Reported Event|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
10821380|NCT00067808|EG002|Reported Event|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
11205616|NCT02230332|BG000|Baseline|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
10810100|NCT04544566|BG002|Baseline|Comparator Tape, Test Tape A and Then Test Tape B|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810101|NCT04544566|BG003|Baseline|Comparator Tape, Test Tape B and Then Test Tape A|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810102|NCT04544566|BG004|Baseline|Test Tape B, Comparator Tape and Then Test Tape A|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810103|NCT04544566|BG005|Baseline|Test Tape B, Test Tape A and Then Comparator Tape|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810104|NCT04544566|BG006|Baseline|Total|Total of all reporting groups
10810105|NCT04544566|FG000|Participant Flow|Test Tape A, Test Tape B, and Then Comparator Tape|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810106|NCT04544566|FG001|Participant Flow|Test Tape A, Comparator Tape and Then Test Tape B|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810107|NCT04544566|FG002|Participant Flow|Comparator Tape, Test Tape A and Then Test Tape B|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810108|NCT04544566|FG003|Participant Flow|Comparator Tape, Test Tape B and Then Test Tape A|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810109|NCT04544566|FG004|Participant Flow|Test Tape B, Comparator Tape and Then Test Tape A|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810110|NCT04544566|FG005|Participant Flow|Test Tape B, Test Tape A and Then Comparator Tape|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation."
10810111|NCT04544566|OG000|Outcome|Test Product A New Adhesive Material|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
11205617|NCT02230332|BG001|Baseline|Placebo|"Placebo capsule taken once daily~Placebo"
11205618|NCT02230332|BG002|Baseline|Total|Total of all reporting groups
11205619|NCT02230332|FG000|Participant Flow|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
10810112|NCT04544566|OG001|Outcome|Test Product B New Adhesion Material|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
10810113|NCT04544566|OG002|Outcome|Comparator|"The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
10810114|NCT04544566|OG000|Outcome|Test Product A New Adhesive Material|Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
10810115|NCT04544566|OG001|Outcome|Test Product B New Adhesion Material|Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
10810116|NCT04544566|OG002|Outcome|Comparator|Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
10810117|NCT04544566|OG000|Outcome|Test Tape A|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin"
10810118|NCT04544566|OG001|Outcome|Test Tape B|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin."
10810119|NCT04544566|OG002|Outcome|Comparator Tape|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the intended use in this clinical investigation."
10810120|NCT04544566|EG000|Reported Event|Test Product A New Adhesive Material|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
11205620|NCT02230332|FG001|Participant Flow|Placebo|"Placebo capsule taken once daily~Placebo"
11205621|NCT02230332|OG000|Outcome|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
11205622|NCT02230332|OG001|Outcome|Placebo|"Placebo capsule taken once daily~Placebo"
11205623|NCT02230332|EG000|Reported Event|Alendronate|"Alendronate in 10mg capsules taken once daily~Alendronate"
11205624|NCT02230332|EG001|Reported Event|Placebo|"Placebo capsule taken once daily~Placebo"
11205625|NCT02230384|BG000|Baseline|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205626|NCT02230384|BG001|Baseline|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205627|NCT02230384|BG002|Baseline|Total|Total of all reporting groups
11205628|NCT02230384|FG000|Participant Flow|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
10821381|NCT00067990|BG000|Baseline|Losartan|within 3 months of transplantation
10821382|NCT00067990|BG001|Baseline|Placebo|within 3 months of transplantation
10821383|NCT00067990|BG002|Baseline|Total|Total of all reporting groups
11205629|NCT02230384|FG001|Participant Flow|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205630|NCT02230384|OG000|Outcome|Active JNJ Drug|Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)
10810121|NCT04544566|EG001|Reported Event|Test Product B New Adhesion Material|"The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
10810122|NCT04544566|EG002|Reported Event|Comparator|"The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.~Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin~Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin"
10821384|NCT00067990|FG000|Participant Flow|Losartan|100 mg/day starting within three months of transplantation
10821385|NCT00067990|FG001|Participant Flow|Placebo|starting within 3 months of transplantation
10821386|NCT00067990|OG000|Outcome|Losartan|within 3 months of transplantation
10821387|NCT00067990|OG001|Outcome|Placebo|within 3 months of transplantation
10821388|NCT00067990|EG000|Reported Event|Losartan|within 3 months of transplantation
10821389|NCT00067990|EG001|Reported Event|Placebo|within 3 months of transplantation
10821390|NCT00068107|BG000|Baseline|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
10821391|NCT00068107|FG000|Participant Flow|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
10821392|NCT00068107|OG000|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
10821393|NCT00068107|OG000|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
10821394|NCT00068107|OG001|Outcome|All Participants at Last Observation|
10821395|NCT00068107|OG000|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
10821396|NCT00068107|EG000|Reported Event|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
10821397|NCT00068237|BG000|Baseline|Surgery + Transfer + Radiation|Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
10821398|NCT00068237|FG000|Participant Flow|Surgery + Transfer + Radiation|Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
10821399|NCT00068237|OG000|Outcome|Surgery + Transfer + Radiation|Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
10821400|NCT00068237|EG000|Reported Event|Surgery + Transfer + Radiation|Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
10821401|NCT00068250|BG000|Baseline|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821402|NCT00068250|BG001|Baseline|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821403|NCT00068250|BG002|Baseline|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821404|NCT00068250|BG003|Baseline|Total|Total of all reporting groups
10821405|NCT00068250|FG000|Participant Flow|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821406|NCT00068250|FG001|Participant Flow|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821407|NCT00068250|FG002|Participant Flow|Phase I: Temozolomide 200 mg|Rituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821408|NCT00068250|FG003|Participant Flow|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821409|NCT00068250|OG000|Outcome|Phase I: Temozolomide 100mg|Phase I: Temozolomide 100mg
10821410|NCT00068250|OG001|Outcome|Phase I: Temozolomide150 mg|Phase I: Temozolomide 150 mg
10821411|NCT00068250|OG000|Outcome|Combined Temozolomide 100mg Arms|Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
10821412|NCT00068250|EG000|Reported Event|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821413|NCT00068250|EG001|Reported Event|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821414|NCT00068250|EG002|Reported Event|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
10821415|NCT00068341|BG000|Baseline|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
11205631|NCT02230384|OG001|Outcome|Placebo Pill|Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
10810123|NCT04542694|BG000|Baseline|Favipiravir (Areplivir)|"Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:~on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient.~Favipiravir: 200 mg coated tablets"
10810124|NCT04542694|BG001|Baseline|Standard of Care|"Arm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes.~Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime.~Standard of care: Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.~Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc."
10810125|NCT04542694|BG002|Baseline|Total|Total of all reporting groups
10810126|NCT04542694|FG000|Participant Flow|Favipiravir (Areplivir)|"Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:~on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient.~Favipiravir: 200 mg coated tablets"
10810127|NCT04542694|FG001|Participant Flow|Standard of Care|"Arm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes.~Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime."
10810128|NCT04542694|OG000|Outcome|Favipiravir (Areplivir)|"Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:~on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient.~Favipiravir: 200 mg coated tablets"
10810129|NCT04542694|OG001|Outcome|Standard of Care|"Arm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes.~Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime."
10810130|NCT04542694|EG000|Reported Event|Favipiravir (Areplivir)|"Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:~on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient.~Favipiravir: 200 mg coated tablets"
10810131|NCT04542694|EG001|Reported Event|Standard of Care|"Arm 2 (n=100) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir or other recommended schemes.~Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime."
11205632|NCT02230384|OG000|Outcome|JNJ Drug|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week"
11205633|NCT02230384|OG001|Outcome|Placebo|"Placebo pill used for one week quit attempt, as part of crossover design.~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
10821416|NCT00068341|BG001|Baseline|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
11205634|NCT02230384|OG000|Outcome|Active JNJ Drug|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week"
11205635|NCT02230384|OG001|Outcome|Placebo Pill|"Placebo pill used for one week quit attempt, as part of crossover design.~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11244301|NCT02510001|BG001|Baseline|Dose Escalation Phase Dose 2.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10810132|NCT04542226|BG000|Baseline|Adult Patients Hospitalized With COVID-19|"Patients eligible for enrollment into the study~Polyoxidonium: Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)"
10810133|NCT04542226|FG000|Participant Flow|Adult Patients Hospitalized With COVID-19|"Patients eligible for enrollment into the study~Polyoxidonium: Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)"
10810134|NCT04542226|OG000|Outcome|Adult Patients Hospitalized With COVID-19|"Patients eligible for enrollment into the study~Polyoxidonium: Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)"
10810135|NCT04542226|EG000|Reported Event|Adult Patients Hospitalized With COVID-19|"Patients eligible for enrollment into the study~Polyoxidonium: Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)"
10810136|NCT04540627|BG000|Baseline|Open-label Palivizumab (Part 1)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min"
10810137|NCT04540627|BG001|Baseline|Double-blind Placebo (Part 2)|"Sodium Chloride 0.9% Solution (Normal Saline)~Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810138|NCT04540627|BG002|Baseline|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810139|NCT04540627|BG003|Baseline|Total|Total of all reporting groups
10810140|NCT04540627|FG000|Participant Flow|Open-label Palivizumab (Part 1)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min"
10810141|NCT04540627|FG001|Participant Flow|Double-blind Placebo (Part 2)|"Sodium Chloride 0.9% Solution (Normal Saline)~Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810142|NCT04540627|FG002|Participant Flow|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810143|NCT04540627|OG000|Outcome|Open-label Palivizumab (Part 1)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min"
10810144|NCT04540627|OG001|Outcome|Double-blind Placebo (Part 2)|"Sodium Chloride 0.9% Solution (Normal Saline)~Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810145|NCT04540627|OG002|Outcome|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810146|NCT04540627|OG000|Outcome|Double-blind Placebo (Part 2)|"Sodium Chloride 0.9% Solution (Normal Saline)~Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810147|NCT04540627|OG001|Outcome|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
11205636|NCT02230384|OG000|Outcome|JNJ Drug|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205637|NCT02230384|OG001|Outcome|Placebo|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205638|NCT02230384|OG000|Outcome|Active JNJ Drug Then Placebo|"200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
11205639|NCT02230384|OG001|Outcome|Placebo Pill Then Active JNJ Drug|"Placebo pill used for one week quit attempt, as part of crossover design.~Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week~Placebo Pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week"
10810148|NCT04540627|OG000|Outcome|Open-label Palivizumab (Part 1)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min"
10810149|NCT04540627|OG000|Outcome|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810150|NCT04540627|EG000|Reported Event|Double-blind Placebo (Part 2)|"Sodium Chloride 0.9% Solution (Normal Saline)~Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810151|NCT04540627|EG001|Reported Event|Double-blind Palivizumab (Synagis™) (Part 2)|"Sterile vial 50mg/0.5mL~Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min~RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)"
10810152|NCT04540510|BG000|Baseline|OPEP Therapy Added to Standard Pneumonia Care|The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.
10810153|NCT04540510|BG001|Baseline|Standard Pneumonia Care|The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
10810154|NCT04540510|BG002|Baseline|Total|Total of all reporting groups
10810155|NCT04540510|FG000|Participant Flow|OPEP Therapy Added to Standard Pneumonia Care|The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.
10810156|NCT04540510|FG001|Participant Flow|Standard Pneumonia Care|The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
10810157|NCT04540510|OG000|Outcome|OPEP Therapy Added to Standard Pneumonia Care|The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.
10810158|NCT04540510|OG001|Outcome|Standard Pneumonia Care|The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
10810159|NCT04540510|EG000|Reported Event|OPEP Therapy Added to Standard Pneumonia Care|The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.
10810160|NCT04540510|EG001|Reported Event|Standard Pneumonia Care|The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
10821417|NCT00068341|BG002|Baseline|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
10821418|NCT00068341|BG003|Baseline|Total|Total of all reporting groups
10821419|NCT00068341|FG000|Participant Flow|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time)~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
10821420|NCT00068341|FG001|Participant Flow|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
10821421|NCT00068341|FG002|Participant Flow|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
10821422|NCT00068341|OG000|Outcome|Arm I: HER2+|(Pre-Op TCH)
10821423|NCT00068341|OG001|Outcome|Arm II: HER2+|(Pre-Op TC, Post-Op Herceptin)
10821424|NCT00068341|OG002|Outcome|HER2-|(Pre-Op TC)
10821425|NCT00068341|OG003|Outcome|Total|
10821426|NCT00068341|OG000|Outcome|Arm I: Her2+|all evaluated subjects.
10821427|NCT00068341|OG001|Outcome|Arm II:Her2+|all evaluated subjects.
10821428|NCT00068341|OG002|Outcome|Arm III: Her2-|all evaluated subjects.
10821429|NCT00068341|OG000|Outcome|Arm I: Her2 +|all enrolled subjects
10821430|NCT00068341|OG001|Outcome|Arm II: Her2 +|all enrolled subjects
10821431|NCT00068341|OG002|Outcome|Arm III: Her -|all enrolled subjects
10821432|NCT00068341|OG000|Outcome|Pathologic CR - Yes|All enrolled subjects
10821433|NCT00068341|OG001|Outcome|Pathologic CR - No|All enrolled subjects
10821434|NCT00068341|OG000|Outcome|Arm I (Pre-op TCH)|enrolled subjects
10821435|NCT00068341|OG001|Outcome|Her2+ (Pre-op TC, Post-op Herceptin)|enrolled subjects
10821436|NCT00068341|OG002|Outcome|Her2- (Pre-op TC)|enrolled subjects
10821437|NCT00068341|EG000|Reported Event|Arm I: HER+ (Pre-Op TCH)|Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
10821438|NCT00068341|EG001|Reported Event|Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)|Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
10821439|NCT00068341|EG002|Reported Event|Arm III: HER2- (Pre-Op TC)|HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
10821440|NCT00068341|EG003|Reported Event|Total|
10821441|NCT00068367|BG000|Baseline|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
10821442|NCT00068367|FG000|Participant Flow|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
10821443|NCT00068367|OG000|Outcome|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
10821444|NCT00068367|EG000|Reported Event|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
10810161|NCT04534764|BG000|Baseline|Total|All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
10810162|NCT04534764|FG000|Participant Flow|Test/Control|Subjects randomized to receive the Test lens during the first period and then received the Control lens during the second period.
10810163|NCT04534764|FG001|Participant Flow|Control/Test|Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period.
10810164|NCT04534764|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
10810165|NCT04534764|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
10810166|NCT04534764|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
10810167|NCT04534764|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
10810168|NCT04534491|BG000|Baseline|Oxybutynin (Oxytrol, BAY839380)|Subjects decided to purchase Oxytrol.
10810169|NCT04534491|FG000|Participant Flow|Oxybutynin (Oxytrol, BAY839380)|Subjects decided to purchase Oxytrol.
10810170|NCT04534491|OG000|Outcome|Oxybutynin (Oxytrol, BAY839380)|Subjects decided to purchase Oxytrol.
10810171|NCT04534491|EG000|Reported Event|Oxybutynin (Oxytrol, BAY839380)|Subjects decided to purchase Oxytrol.
11205640|NCT02230384|EG000|Reported Event|JNJ Drug|Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.)
11205641|NCT02230384|EG001|Reported Event|Placebo|Period during which Participants received Placebo pill: 200 mg/day (100 mg b.i.d.)
11205642|NCT02230527|BG000|Baseline|Clopidogrel|"Clopidogrel 75mg by mouth daily~Clopidogrel: 75mg once a day by mouth"
11205643|NCT02230527|BG001|Baseline|Ticagrelor|"Ticagrelor 90mg by mouth twice daily~Ticagrelor: 90mg twice a day by mouth"
10810172|NCT04534465|BG000|Baseline|All Population|MiraLAX Sachet (17g) + Flavor blend (2g, 4g, 6g, 8g and 10g mannitol total). Baseline data were not collected separately for Arms/Groups.
10810173|NCT04534465|FG000|Participant Flow|Dosing Arm 1|MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
10810174|NCT04534465|FG001|Participant Flow|Dosing Arm 2|MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
10810175|NCT04534465|FG002|Participant Flow|Dosing Arm 3|MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
10810176|NCT04534465|FG003|Participant Flow|Dosing Arm 4|MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
10810177|NCT04534465|FG004|Participant Flow|Dosing Arm 5|MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
10810178|NCT04534465|OG000|Outcome|Dosing Arm 1|MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
10810179|NCT04534465|OG001|Outcome|Dosing Arm 2|MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
10810180|NCT04534465|OG002|Outcome|Dosiing Arm 3|MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
10810181|NCT04534465|OG003|Outcome|Dosing Arm 4|MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
10810182|NCT04534465|OG004|Outcome|Dosing Arm 5|MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
10810183|NCT04534465|EG000|Reported Event|Dosing Arm 1|MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
10810184|NCT04534465|EG001|Reported Event|Dosing Arm 2|MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
10810185|NCT04534465|EG002|Reported Event|Dosing Arm 3|MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
10810186|NCT04534465|EG003|Reported Event|Dosing Arm 4|MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
10810187|NCT04534465|EG004|Reported Event|Dosing Arm 5|MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
10821445|NCT00068380|BG000|Baseline|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10821446|NCT00068380|FG000|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10821447|NCT00068380|OG000|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10821448|NCT00068380|EG000|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
10821449|NCT00068393|BG000|Baseline|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
11205644|NCT02230527|BG002|Baseline|Total|Total of all reporting groups
11205645|NCT02230527|FG000|Participant Flow|Clopidogrel|"Clopidogrel 75mg by mouth daily~Clopidogrel: 75mg once a day by mouth"
11205646|NCT02230527|FG001|Participant Flow|Ticagrelor|"Ticagrelor 90mg by mouth twice daily~Ticagrelor: 90mg twice a day by mouth"
11205647|NCT02230527|OG000|Outcome|Clopidogrel|"Clopidogrel 75mg by mouth daily~Clopidogrel: 75mg once a day by mouth"
11205648|NCT02230527|OG001|Outcome|Ticagrelor|"Ticagrelor 90mg by mouth twice daily~Ticagrelor: 90mg twice a day by mouth"
11205649|NCT02230527|EG000|Reported Event|Clopidogrel|"Clopidogrel 75mg by mouth daily~Clopidogrel: 75mg once a day by mouth"
11205650|NCT02230527|EG001|Reported Event|Ticagrelor|"Ticagrelor 90mg by mouth twice daily~Ticagrelor: 90mg twice a day by mouth"
10810188|NCT04533204|BG000|Baseline|Mnemonic Strategy Training|"Training using mnemonic strategies~mnemonic strategy training: training using mnemonic strategies"
10810189|NCT04533204|BG001|Baseline|Spaced Retrieval Training|"Training using spaced retrieval~spaced retrieval training: training using spaced retrieval"
11205651|NCT02230540|BG000|Baseline|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
11205652|NCT02230540|FG000|Participant Flow|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
11205653|NCT02230540|FG001|Participant Flow|Sequence B|"Based on results from sequence A, sequence B may or may not be initiated.~Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product B in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices)."
11205654|NCT02230540|OG000|Outcome|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
11205655|NCT02230540|EG000|Reported Event|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
11205656|NCT02230566|BG000|Baseline|Group A: 4 mg/kg UX003|4 mg/kg UX003 QOW through Week 46
11205657|NCT02230566|BG001|Baseline|Group B: 8 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 8 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205658|NCT02230566|BG002|Baseline|Group C: 16 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 16 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205659|NCT02230566|BG003|Baseline|Group D: 24 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 24 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205660|NCT02230566|BG004|Baseline|Total|Total of all reporting groups
11205661|NCT02230566|FG000|Participant Flow|Group A: 4 mg/kg UX003|4 mg/kg UX003 every other week (QOW) through Week 46
11205662|NCT02230566|FG001|Participant Flow|Group B: 8 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 8 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205663|NCT02230566|FG002|Participant Flow|Group C: 16 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 16 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205664|NCT02230566|FG003|Participant Flow|Group D: 24 Weeks Placebo Then 4 mg/kg UX003|Placebo QOW for the first 24 weeks followed by 4 mg/kg UX003 QOW through Week 46
11205665|NCT02230566|OG000|Outcome|UX003 4 mg/kg|Participants were randomized 1:1:1:1 to 1 of 4 treatment sequence groups to either start treatment with 4 mg/kg UX003 (Group A), or placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study and cross over to 4 mg/kg UX003. Participants were dosed QOW through Week 46. All groups received a minimum of 24 weeks of treatment with 4 mg/kg UX003 QOW.
11205666|NCT02230566|EG000|Reported Event|Placebo|Participants received placebo for the first 8 weeks (Group B), 16 weeks (Group C) or 24 weeks (Group D) of the study, based on the blind-start design.
11205667|NCT02230566|EG001|Reported Event|UX003 Active Treatment|Participants received 4 mg/kg UX003 QOW per group assignment (based on the blind-start design) and were dosed through Week 46. All groups received a minimum of 24 weeks of treatment with UX003.
11205668|NCT02230579|BG000|Baseline|Cohort SAD1 Fasted|"5mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205669|NCT02230579|BG001|Baseline|Cohort SAD2 Fasted|"20mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205670|NCT02230579|BG002|Baseline|Cohort SAD3 Fasted|"40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205671|NCT02230579|BG003|Baseline|Cohort SAD4 Fasted|"80mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810190|NCT04533204|BG002|Baseline|Total|Total of all reporting groups
10810191|NCT04533204|FG000|Participant Flow|Mnemonic Strategy Training|"Training using mnemonic strategies~mnemonic strategy training: training using mnemonic strategies"
10810192|NCT04533204|FG001|Participant Flow|Spaced Retrieval Training|"Training using spaced retrieval~spaced retrieval training: training using spaced retrieval"
10810193|NCT04533204|OG000|Outcome|Mnemonic Strategy Training|"Training using mnemonic strategies~mnemonic strategy training: training using mnemonic strategies"
10810194|NCT04533204|OG001|Outcome|Spaced Retrieval Training|"Training using spaced retrieval~spaced retrieval training: training using spaced retrieval"
11205672|NCT02230579|BG004|Baseline|Cohort SAD5 Fasted|"120mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205673|NCT02230579|BG005|Baseline|Cohort SAD6 Fed|"Cohort SAD6, reusing volunteers from previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability~40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205674|NCT02230579|BG006|Baseline|Placebo|"Placebo to match MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Two volunteers within each cohort (SAD1 to SAD6) were scheduled to receive placebo in a double blind manner."
11205675|NCT02230579|BG007|Baseline|Total|Total of all reporting groups
10810195|NCT04533204|EG000|Reported Event|Mnemonic Strategy Training|"Training using mnemonic strategies~mnemonic strategy training: training using mnemonic strategies"
10810196|NCT04533204|EG001|Reported Event|Spaced Retrieval Training|"Training using spaced retrieval~spaced retrieval training: training using spaced retrieval"
10810197|NCT04532164|BG000|Baseline|Photoallergic Reaction Test|During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation and on the treated non-irradiated skin test site without UV radiation, two times per week for three consecutive weeks. After 10 days of Rest Phase, during the Challenge Phase, participants received same procedure on the two virgin sites (treated sites) as in Induction Phase, and two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Test sites were evaluated at 24, 48, and 72 hours after irradiation using the same grading scale used during Induction Phase.
10810198|NCT04532164|FG000|Participant Flow|Photoallergic Reaction Test|During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation and on the treated non-irradiated skin test site without UV radiation, two times per week for three consecutive weeks. After 10 days of Rest Phase, during the Challenge Phase, participants received same procedure on the two virgin sites (treated sites) as in Induction Phase, and two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Test sites were evaluated at 24, 48, and 72 hours after irradiation using the same grading scale used during Induction Phase.
10810199|NCT04532164|OG000|Outcome|Butenafine HCl 1% (BAY1896425) - Challenge Phase|5 μl/cm^2 of the Butenafine HCl 1% was applied directly to each of the two virgin sites (treated sites) adjacent to the induction patch sites and covered with Hilltop chambers with Webril pad and tape was applied over the chambers to secure the occlusive patches to the skin. Two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Sites were at least 2.5 cm apart. The patches were removed 24 hours later and the sites were lightly wiped. Test sites were evaluated. Butenafine HCl 1% (2 μl/cm^2) was applied to the treated irradiated site. After 15 minutes, the treated irradiated site and the untreated irradiated site were irradiated with 0.5 MED of UVA/UVB irradiation followed by 10 Joules/cm^2 of UVA from a xenon arc solar simulator equipped with a Schott WG345 to eliminate UVB radiation. The remaining sites served as the treated non-irradiated site and untreated non-irradiated site.
10810200|NCT04532164|OG000|Outcome|Butenafine HCl 1% (BAY1896425) - Induction Phase|To each of two test sites, approximately 20 μl/cm^2 of the Butenafine HCl 1% was applied directly to the skin and covered with a 25 mm Hilltop chamber with a Webril® pad (2 cm in diameter, within an area of approximately 3 cm^2), and tape was applied over the chamber to secure the occlusive patch to the skin. On the next day, the chambers were removed and both test sites were lightly wiped. Approximately 2 μl/cm^2 of Butenafine HCl 1% was reapplied directly to the skin and lightly spread over the treated irradiated test site. The treated non-irradiated test site did not receive a similar reapplication. Between 5 and 15 minutes after application, the treated irradiated test site was irradiated with two times the subject's Minimal Erythema Dose (MED). Evaluation of the test sites occurred two days after the irradiation. This procedure was repeated two times per week for three consecutive weeks for a total of 6 induction exposures per test site.
10810201|NCT04532164|EG000|Reported Event|Photoallergic Reaction Test|During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation and on the treated non-irradiated skin test site without UV radiation, two times per week for three consecutive weeks. After 10 days of Rest Phase, during the Challenge Phase, participants received same procedure on the two virgin sites (treated sites) as in Induction Phase, and two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Test sites were evaluated at 24, 48, and 72 hours after irradiation using the same grading scale used during Induction Phase.
10810202|NCT04531813|BG000|Baseline|Cumulative Irritation Test|Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.
10810203|NCT04531813|FG000|Participant Flow|Cumulative Irritation Test|Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.
10810204|NCT04531813|OG000|Outcome|Cumulative Irritation Test|Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.
10810205|NCT04531813|EG000|Reported Event|Cumulative Irritation Test|Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.
10821450|NCT00068393|FG000|Participant Flow|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
10821451|NCT00068393|OG000|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
11205676|NCT02230579|FG000|Participant Flow|Cohort SAD1 Fasted|"5mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205677|NCT02230579|FG001|Participant Flow|Cohort SAD2 Fasted|"20mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810206|NCT04531527|BG000|Baseline|Phototoxicity Reaction Test|Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
10810207|NCT04531527|FG000|Participant Flow|Phototoxicity Reaction Test|Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
10810208|NCT04531527|OG000|Outcome|Phototoxicity Reaction Test|Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
10810209|NCT04531527|EG000|Reported Event|Phototoxicity Reaction Test|Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
10810210|NCT04531540|BG000|Baseline|Repeated Insult Patch Test|During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.
10810211|NCT04531540|FG000|Participant Flow|Repeated Insult Patch Test|During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.
10810212|NCT04531540|OG000|Outcome|Repeated Insult Patch Test|During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.
10810213|NCT04531540|EG000|Reported Event|Repeated Insult Patch Test|During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.
10810214|NCT04530591|BG000|Baseline|Patient Participants|"This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, looks-like prototypes of such a device.~Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.~Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, looks-like prototypes of a naloxone delivery device."
10810215|NCT04530591|FG000|Participant Flow|Patient Participants|"This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, looks-like prototypes of such a device.~Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.~Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, looks-like prototypes of a naloxone delivery device."
10810216|NCT04530591|OG000|Outcome|Patient Participants|"This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, looks-like prototypes of such a device.~Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.~Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, looks-like prototypes of a naloxone delivery device."
10810217|NCT04530591|EG000|Reported Event|Patient Participants|"This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, looks-like prototypes of such a device.~Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.~Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, looks-like prototypes of a naloxone delivery device."
10821452|NCT00068393|EG000|Reported Event|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
10821453|NCT00068406|BG000|Baseline|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
10821454|NCT00068406|FG000|Participant Flow|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
10821455|NCT00068406|OG000|Outcome|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
10821456|NCT00068406|EG000|Reported Event|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
10821457|NCT00068419|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
10821458|NCT00068419|FG000|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
10821459|NCT00068419|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
10821460|NCT00068419|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
10821461|NCT00068445|BG000|Baseline|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821462|NCT00068445|BG001|Baseline|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821463|NCT00068445|BG002|Baseline|Total|Total of all reporting groups
10821464|NCT00068445|FG000|Participant Flow|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821465|NCT00068445|FG001|Participant Flow|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821466|NCT00068445|OG000|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10810218|NCT04615832|BG000|Baseline|Toffee Full Face Mask|Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
10810219|NCT04615832|FG000|Participant Flow|Toffee Full Face Mask|Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
10810220|NCT04615832|OG000|Outcome|Toffee Full Face Mask|Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
10810221|NCT04615832|EG000|Reported Event|Toffee Full Face Mask|"Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks.~Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment"
10810222|NCT04093258|BG000|Baseline|All Subjects|All subjects dispensed a study lens.
10810223|NCT04093258|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.
10810224|NCT04093258|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
10810225|NCT04093258|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
10810226|NCT04093258|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
10810227|NCT04093258|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
10810228|NCT04093258|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
10810229|NCT04011826|BG000|Baseline|Experimental: Experimental Trial Nasal Mask|"Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.~Device: Trial nasal mask (F&P): This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3."
10810230|NCT04011826|FG000|Participant Flow|Experimental: Experimental Trial Nasal Mask|"Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.~Device: Trial nasal mask (F&P): This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3."
10810231|NCT04011826|OG000|Outcome|Experimental: Experimental Trial Nasal Mask|"Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.~Device: Trial nasal mask (F&P): This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3."
10810232|NCT04011826|EG000|Reported Event|Experimental: Experimental Trial Nasal Mask|"Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.~Device: Trial nasal mask (F&P): This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3."
10810233|NCT03993379|BG000|Baseline|Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line|"Histologically or cytologically confirmed solid tumor who have received no prior treatment~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810234|NCT03993379|BG001|Baseline|Cohort A2: CX-072 in Combination With Ipilimumab|"Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810235|NCT03993379|BG002|Baseline|Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed|"Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810236|NCT03993379|BG003|Baseline|Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant|"Neo-adjuvant study in subjects with histologically confirmed solid tumor~CX-072 in combination with ipilimumab~Part B Dosing Regimen:~Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810237|NCT03993379|BG004|Baseline|Total|Total of all reporting groups
10810238|NCT03993379|FG000|Participant Flow|Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line|"Histologically or cytologically confirmed solid tumor who have received no prior treatment~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810239|NCT03993379|FG001|Participant Flow|Cohort A2: CX-072 in Combination With Ipilimumab|"Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10821467|NCT00068445|OG001|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10810240|NCT03993379|FG002|Participant Flow|Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed|"Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810241|NCT03993379|FG003|Participant Flow|Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant|"Neo-adjuvant study in subjects with histologically confirmed solid tumor~CX-072 in combination with ipilimumab~Part B Dosing Regimen:~Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810242|NCT03993379|OG000|Outcome|Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line|"Histologically or cytologically confirmed solid tumor who have received no prior treatment~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810243|NCT03993379|OG001|Outcome|Cohort A2: CX-072 in Combination With Ipilimumab|"Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810244|NCT03993379|OG002|Outcome|Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed|"Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810245|NCT03993379|OG003|Outcome|Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant|"Neo-adjuvant study in subjects with histologically confirmed solid tumor~CX-072 in combination with ipilimumab~Part B Dosing Regimen:~Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810246|NCT03993379|EG000|Reported Event|Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line|"Histologically or cytologically confirmed solid tumor who have received no prior treatment~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810247|NCT03993379|EG001|Reported Event|Cohort A2: CX-072 in Combination With Ipilimumab|"Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810248|NCT03993379|EG002|Reported Event|Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed|"Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy~CX-072 in combination with ipilimumab~Part A Dosing Regimen:~Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810249|NCT03993379|EG003|Reported Event|Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant|"Neo-adjuvant study in subjects with histologically confirmed solid tumor~CX-072 in combination with ipilimumab~Part B Dosing Regimen:~Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w~Monotherapy treatment: 800 mg CX-072, q2w"
10810250|NCT03956615|BG000|Baseline|Clinically Suspected or Pathologically Confirmed Multiple Myeloma.|Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
10810251|NCT03956615|FG000|Participant Flow|Clinically Suspected or Pathologically Confirmed Multiple Myeloma.|Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
10810252|NCT03956615|OG000|Outcome|Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.|Only 1 arm/group in this trial
10810253|NCT03956615|EG000|Reported Event|Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.|Only 1 arm/group in this trial
10810254|NCT03803059|BG000|Baseline|SkinPen Precision System|"Microneedle treatment to neck areas using SkinPen Precision system: Surgical instrument motors and accessories/attachments/Hydrogel.~At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.~On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as clinic) treated each subject's fine lines and wrinkles, on the neck with SkinPen Precision System at depths of up to 2.5mm. Each subject's treatment depth was recorded. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.~During the treatment period (days 1-90), subjects used the supporting materials[SKINFUSE® Purify Cleansing Complex, Reclaim Hydrating Support (Moisturizer), and Shield Zinc Oxide Sunscreen] as directed."
10810255|NCT03803059|FG000|Participant Flow|Skinpen Precision System|"Microneedle treatment to neck areas using SkinPen Precision system which includes: Surgical instrument motors and accessories/attachments/Hydrogel~A total of 32 subjects completed study participation.~At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.~On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as clinic) treated each subject's fine lines and wrinkles, on the neck with SkinPen Precision System at depths of up to 2.5mm. Each subject's treatment depth was recorded. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.~During the treatment period (days 1-90), subjects used the supporting materials[SKINFUSE® Purify Cleansing Complex, Reclaim Hydrating Support (Moisturizer), and Shield Zinc Oxide Sunscreen] as directed."
10810256|NCT03803059|OG000|Outcome|Skinpen Precision System|The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
10810257|NCT03803059|OG000|Outcome|SkinPen Precision System|The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
10810258|NCT03803059|EG000|Reported Event|Skinpen Precision System|"Microneedle treatment to neck areas.~SkinPen Precision: Surgical instrument motors and accessories/attachments/Hydrogel"
10810259|NCT03723590|BG000|Baseline|Esterified Hyaluronic Acid Matrix|Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
10810260|NCT03723590|FG000|Participant Flow|Esterified Hyaluronic Acid Matrix|Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
10810261|NCT03723590|OG000|Outcome|Esterified Hyaluronic Acid Matrix|Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
10810262|NCT03723590|EG000|Reported Event|Esterified Hyaluronic Acid Matrix|Esterified Hyaluronic Acid Matrix: A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
10810263|NCT03720392|BG000|Baseline|FMT Capsules|"Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT.~A standard dose of oral FMT is 15 capsules per day for two consecutive days,~FMT: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body."
10810264|NCT03720392|BG001|Baseline|Placebo Capsules|"Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT.~A standard dose of oral Placebo is 15 capsules per day for two consecutive days,~Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect."
10810265|NCT03720392|BG002|Baseline|Total|Total of all reporting groups
10810266|NCT03720392|FG000|Participant Flow|FMT Capsules|"Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT.~A standard dose of oral FMT is 15 capsules per day for two consecutive days,~FMT: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body."
10810267|NCT03720392|FG001|Participant Flow|Placebo Capsules|"Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT.~A standard dose of oral Placebo is 15 capsules per day for two consecutive days,~Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect."
10810268|NCT03720392|OG000|Outcome|FMT Capsules|"Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT.~A standard dose of oral FMT is 15 capsules per day for two consecutive days,~FMT: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body."
10810269|NCT03720392|OG001|Outcome|Placebo Capsules|"Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT.~A standard dose of oral Placebo is 15 capsules per day for two consecutive days,~Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect."
10810270|NCT03720392|EG000|Reported Event|FMT Capsules|"Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT.~A standard dose of oral FMT is 15 capsules per day for two consecutive days,~FMT: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body."
10810271|NCT03720392|EG001|Reported Event|Placebo Capsules|"Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT.~A standard dose of oral Placebo is 15 capsules per day for two consecutive days,~Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect."
10810272|NCT03515226|BG000|Baseline|Traditional Training|"24 hours of didactic and simulated case role play training in CBT principles, depression assessment and cultural competency.~Traditional Training: Training using didactics and role plays"
10810273|NCT03515226|BG001|Baseline|ITS Based Training|"Traditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies.~ITS based training: Training using computerized adaptive training in addition to role play"
10810274|NCT03515226|BG002|Baseline|Total|Total of all reporting groups
10810275|NCT03515226|FG000|Participant Flow|Traditional Training|"25 hours of didactic and simulated case role play training in CBT principles, depression assessment and cultural competency.~Traditional Training: Training using didactics and role plays"
10810276|NCT03515226|FG001|Participant Flow|ITS Based Training|"Traditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies.~ITS based training: Training using computerized adaptive training in addition to role play"
10810277|NCT03515226|OG000|Outcome|Traditional Training|"25 hours of didactic and simulated case role play training in CBT principles, depression assessment and cultural competency.~Traditional Training: Training using didactics and role plays"
11244302|NCT02510001|BG002|Baseline|Dose Escalation Phase Dose 3.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10810278|NCT03515226|OG001|Outcome|ITS Based Training|"Traditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies.~ITS based training: Training using computerized adaptive training in addition to role play"
10810279|NCT03515226|OG000|Outcome|Traditional Training|"24 hours of didactic and simulated case role play training in CBT principles, depression assessment and cultural competency.~Traditional Training: Training using didactics and role plays"
10810280|NCT03515226|EG000|Reported Event|Traditional Training|"24 hours of didactic and simulated case role play training in CBT principles, depression assessment and cultural competency.~Traditional Training: Training using didactics and role plays"
10810281|NCT03515226|EG001|Reported Event|ITS Based Training|"Traditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies.~ITS based training: Training using computerized adaptive training in addition to role play"
10810282|NCT03430895|BG000|Baseline|Combination of Durvalumab and Tremelimumab|"Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months).~durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses."
10810283|NCT03430895|FG000|Participant Flow|Combination of Durvalumab and Tremelimumab|"Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months).~durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses."
10810284|NCT03430895|OG000|Outcome|Combination of Durvalumab and Tremelimumab|"Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months).~durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses."
10810285|NCT03430895|EG000|Reported Event|Combination of Durvalumab and Tremelimumab|"Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting at Week 16 for 9 doses (total treatment duration of 12 months).~durvalumab and tremelimumab: Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses."
10810286|NCT03321617|BG000|Baseline|POMA 40mg BID (80mg)|"Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810287|NCT03321617|BG001|Baseline|POMA 80mg BID (160 mg)|"Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810288|NCT03321617|BG002|Baseline|POMA 120mg BID (240mg)|"Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810289|NCT03321617|BG003|Baseline|POMA 160 mg BID (320 mg)|"Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810290|NCT03321617|BG004|Baseline|Total|Total of all reporting groups
10810291|NCT03321617|FG000|Participant Flow|POMA 40mg BID (80mg)|"Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810292|NCT03321617|FG001|Participant Flow|POMA 80mg BID (160 mg)|"Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810293|NCT03321617|FG002|Participant Flow|POMA 120mg BID (240mg)|"Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810294|NCT03321617|FG003|Participant Flow|POMA 160 mg BID (320 mg)|"Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810295|NCT03321617|OG000|Outcome|POMA 40mg BID (80mg)|"Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810296|NCT03321617|OG001|Outcome|POMA 80mg BID (160 mg)|"Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810297|NCT03321617|OG002|Outcome|POMA 120mg BID (240mg)|"Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810298|NCT03321617|OG003|Outcome|POMA 160 mg BID (320 mg)|"Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810299|NCT03321617|EG000|Reported Event|POMA 40mg BID (80mg)|"Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810300|NCT03321617|EG001|Reported Event|POMA 80mg BID (160 mg)|"Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810301|NCT03321617|EG002|Reported Event|POMA 120mg BID (240mg)|"Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810302|NCT03321617|EG003|Reported Event|POMA 160 mg BID (320 mg)|"Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days~Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist"
10810303|NCT03230838|BG000|Baseline|Ceftolozane/Tazobactam|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
10810304|NCT03230838|BG001|Baseline|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
10810305|NCT03230838|BG002|Baseline|Total|Total of all reporting groups
10810306|NCT03230838|FG000|Participant Flow|Ceftolozane/Tazobactam|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
10810307|NCT03230838|FG001|Participant Flow|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
10810308|NCT03230838|OG000|Outcome|Ceftolozane/Tazobactam|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
10810309|NCT03230838|OG001|Outcome|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
10810310|NCT03230838|EG000|Reported Event|Ceftolozane/Tazobactam|Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered IV every 8 hours for 7-14 days.
10810311|NCT03230838|EG001|Reported Event|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
10821468|NCT00068445|EG000|Reported Event|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821469|NCT00068445|EG001|Reported Event|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
10821470|NCT00068575|BG000|Baseline|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
10821471|NCT00068575|FG000|Participant Flow|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
10821472|NCT00068575|OG000|Outcome|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
10821473|NCT00068575|EG000|Reported Event|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
10821474|NCT00068588|BG000|Baseline|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821475|NCT00068588|BG001|Baseline|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821476|NCT00068588|BG002|Baseline|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821477|NCT00068588|BG003|Baseline|Total|Total of all reporting groups
10821478|NCT00068588|FG000|Participant Flow|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821479|NCT00068588|FG001|Participant Flow|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821480|NCT00068588|FG002|Participant Flow|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821481|NCT00068588|OG000|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821482|NCT00068588|OG001|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821483|NCT00068588|OG002|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821484|NCT00068588|EG000|Reported Event|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821485|NCT00068588|EG001|Reported Event|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
10821486|NCT00068601|BG000|Baseline|Arm 1|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
10821487|NCT00068601|BG001|Baseline|Arm 2|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
10821488|NCT00068601|BG002|Baseline|Total|Total of all reporting groups
10821489|NCT00068601|FG000|Participant Flow|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
10821490|NCT00068601|FG001|Participant Flow|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
10821491|NCT00068601|OG000|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
10810312|NCT03183778|BG000|Baseline|Patiromer + Research Diet|"During the first phase (week 2), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (less than or equal to 1 serving/day), and eliminates high-potassium fruits and vegetables.~During the second phase (weeks 3 and 4), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources.~Patiromer: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.~Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet"
10810313|NCT03183778|FG000|Participant Flow|Patiromer + Research Diet|"During the first phase (week 2), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (less than or equal to 1 serving/day), and eliminates high-potassium fruits and vegetables.~During the second phase (weeks 3 and 4), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources.~Patiromer: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.~Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet"
10810314|NCT03183778|OG000|Outcome|Patiromer + Research Diet|"During the first phase (week 2), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (less than or equal to 1 serving/day), and eliminates high-potassium fruits and vegetables.~During the second phase (weeks 3 and 4), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources.~Patiromer: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.~Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet"
10810315|NCT03183778|EG000|Reported Event|Patiromer + Research Diet|"During the first phase (week 2), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (less than or equal to 1 serving/day), and eliminates high-potassium fruits and vegetables.~During the second phase (weeks 3 and 4), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources.~Patiromer: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.~Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet"
10810316|NCT03113955|BG000|Baseline|Single -Arm|"A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma~Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)"
10810317|NCT03113955|FG000|Participant Flow|Single -Arm|"A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma~Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)"
10810318|NCT03113955|OG000|Outcome|Single -Arm|"A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma~Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)"
10810319|NCT03113955|EG000|Reported Event|Single -Arm|"A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma~Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)"
10810320|NCT02995694|BG000|Baseline|Estradiol Vaginal Cream|Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)
10810321|NCT02995694|BG001|Baseline|Estrace Vaginal Cream|Estrace Vaginal Cream, 0.01%, administered once daily for 7 days. Estrace Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)
10810322|NCT02995694|BG002|Baseline|Placebo|Placebo Cream, administered once daily for 7 days. Placebo Cream, (1 x 2 g for 7 days)
10810323|NCT02995694|BG003|Baseline|Total|Total of all reporting groups
10810324|NCT02995694|FG000|Participant Flow|Test|"Estradiol Vaginal Cream~Estradiol: Estradiol Vaginal Cream"
10810325|NCT02995694|FG001|Participant Flow|Reference.|"Estrace Vaginal Cream~Reference: Estrace Vaginal Cream"
10810326|NCT02995694|FG002|Participant Flow|Placebos|"Placebo with no active pharmaceutical ingredients. Topical vaginal cream~Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream"
10810327|NCT02995694|OG000|Outcome|Test|"Estradiol Vaginal Cream~Estradiol: Estradiol Vaginal Cream"
10810328|NCT02995694|OG001|Outcome|Reference.|"Estrace Vaginal Cream~Reference: Estrace Vaginal Cream"
11244303|NCT02510001|BG003|Baseline|Dose Escalation Phase Dose 4.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10810329|NCT02995694|OG002|Outcome|Placebos|"Placebo with no active pharmaceutical ingredients. Topical vaginal cream~Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream"
10810330|NCT02995694|OG000|Outcome|Estradiol Vaginal Cream|Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)
10810331|NCT02995694|OG001|Outcome|Reference|Estrace Vaginal Cream
10810332|NCT02995694|OG002|Outcome|Placebo|Placebo arm
10810333|NCT02995694|EG000|Reported Event|Test|"Estradiol Vaginal Cream~Estradiol: Estradiol Vaginal Cream"
10810334|NCT02995694|EG001|Reported Event|Reference.|"Estrace Vaginal Cream~Reference: Estrace Vaginal Cream"
10810335|NCT02995694|EG002|Reported Event|Placebos|"Placebo with no active pharmaceutical ingredients. Topical vaginal cream~Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream"
10810336|NCT02700698|BG000|Baseline|Healthy Lean|Healthy lean women, 25-35 years
10810337|NCT02700698|BG001|Baseline|Overweight/Obese With/Without IR|Overweight/obese with/without insulin resistant women, 25-35 years
10810338|NCT02700698|BG002|Baseline|Total|Total of all reporting groups
10810339|NCT02700698|FG000|Participant Flow|Healthy Lean|Healthy lean women, 25-35 years
10810340|NCT02700698|FG001|Participant Flow|Overweight/Obese +/- IR|Overweight/obese and/or insulin resistant women, 25-35 years
10810341|NCT02700698|OG000|Outcome|Healthy Lean|Healthy lean women, 25-35 years
10810342|NCT02700698|OG001|Outcome|Overweight/Obese +/- IR|Overweight/obese and/or insulin resistant women, 25-35 years
10810343|NCT02700698|EG000|Reported Event|Healthy Lean|Healthy lean women, 25-35 years
10810344|NCT02700698|EG001|Reported Event|Overweight/Obese +/- IR|Overweight/obese and/or insulin resistant women, 25-35 years
10810345|NCT02699086|BG000|Baseline|Low Dose + High Dose|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810346|NCT02699086|FG000|Participant Flow|Low Dose + Low Dose|"1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 + 28 days~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810347|NCT02699086|FG001|Participant Flow|Low Dose + High Dose|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810348|NCT02699086|OG000|Outcome|Low Dose + High Dose (at Week 8)|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810349|NCT02699086|OG000|Outcome|Low Dose + High Dose (Week 0-4)|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.~The score change is calculated from the score of week 4 comparing to week 0."
10810350|NCT02699086|OG001|Outcome|Low Dose + High Dose (Week 0-8)|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.~The score change is calculated from the score of week 8 comparing to week 0."
10810351|NCT02699086|OG000|Outcome|Low Dose + High Dose (at Week 4)|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810352|NCT02699086|OG001|Outcome|Low Dose + High Dose (at Week 8)|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810353|NCT02699086|EG000|Reported Event|Low Dose + High Dose|"1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals~PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient."
10810354|NCT02698865|BG000|Baseline|Monovisc|Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.
10810355|NCT02698865|BG001|Baseline|Saline|Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
10810356|NCT02698865|BG002|Baseline|Total|Total of all reporting groups
10810357|NCT02698865|FG000|Participant Flow|Monovisc|Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.
10810358|NCT02698865|FG001|Participant Flow|Saline|Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
10810359|NCT02698865|OG000|Outcome|Monovisc|Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.
10810360|NCT02698865|OG001|Outcome|Saline|Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
10810361|NCT02698865|EG000|Reported Event|Monovisc|Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.
10810362|NCT02698865|EG001|Reported Event|Saline|Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
10810363|NCT02660086|BG000|Baseline|Personalized Feedback|"Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices~Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)"
10810364|NCT02660086|BG001|Baseline|Control|Monthly letters with general nutrition information
10810365|NCT02660086|BG002|Baseline|Total|Total of all reporting groups
10810366|NCT02660086|FG000|Participant Flow|Personalized Feedback|"Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices~Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)"
10810367|NCT02660086|FG001|Participant Flow|Control|Monthly letters with general nutrition information
10810368|NCT02660086|OG000|Outcome|Personalized Feedback|"Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices~Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)"
10810369|NCT02660086|OG001|Outcome|Control|Monthly letters with general nutrition information
10810370|NCT02660086|EG000|Reported Event|Personalized Feedback|"Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices~Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)"
10810371|NCT02660086|EG001|Reported Event|Control|Monthly letters with general nutrition information
10810372|NCT02335749|BG000|Baseline|Treatment With Small Area Applicator|"Each enrolled subject was treated on a single thigh, in the distal region.~The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments."
10810373|NCT02335749|FG000|Participant Flow|Treatment With Small Area Applicator|"Each enrolled subject was treated on a single thigh, in the distal region.~The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments."
10810374|NCT02335749|OG000|Outcome|Treatment With Small Area Applicator|"Each enrolled subject was treated on a single thigh, in the distal region.~The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments."
10810375|NCT02335749|EG000|Reported Event|Treatment With Small Area Applicator|"Each enrolled subject was treated on a single thigh, in the distal region.~The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments."
10810376|NCT02129647|BG000|Baseline|Axitinib|5 mg axitinib orally twice daily, with increase to 7 mg orally twice daily and 10 mg orally twice daily after 2 and 4 weeks. Axitinib will be given continuously in 28-day cycles until disease progression or unacceptable toxicity.
10810377|NCT02129647|FG000|Participant Flow|Axitinib|5 mg axitinib orally twice daily, with increase to 7 mg orally twice daily and 10 mg orally twice daily after 2 and 4 weeks. Axitinib will be given continuously in 28-day cycles until disease progression or unacceptable toxicity.
10810378|NCT02129647|OG000|Outcome|Axitinib|5 mg axitinib orally twice daily, with increase to 7 mg orally twice daily and 10 mg orally twice daily after 2 and 4 weeks. Axitinib will be given continuously in 28-day cycles until disease progression or unacceptable toxicity.
10810379|NCT02129647|EG000|Reported Event|Axitinib|5 mg axitinib orally twice daily, with increase to 7 mg orally twice daily and 10 mg orally twice daily after 2 and 4 weeks. Axitinib will be given continuously in 28-day cycles until disease progression or unacceptable toxicity.
10810380|NCT02071901|BG000|Baseline|Supportive Care (Eltrombopag Olamine)|"Patients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.~eltrombopag olamine: Given PO"
10810381|NCT02071901|FG000|Participant Flow|Supportive Care (Eltrombopag Olamine)|"Patients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.~eltrombopag olamine: Given PO"
10810382|NCT02071901|OG000|Outcome|Supportive Care (Eltrombopag Olamine)|"Patients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.~eltrombopag olamine: Given PO"
10810383|NCT02071901|EG000|Reported Event|Supportive Care (Eltrombopag Olamine)|"Patients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.~eltrombopag olamine: Given PO"
10810384|NCT01959139|BG000|Baseline|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4|"PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;~Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours;~Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours;~Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours;~5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810385|NCT01959139|BG001|Baseline|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only|"PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810386|NCT01959139|BG002|Baseline|Phase II: mFOLFIRINOX|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
11205678|NCT02230579|FG002|Participant Flow|Cohort SAD3 Fasted|"40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810387|NCT01959139|BG003|Baseline|Phase II: mFOLFIRINOX + PEGPH20|"Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810388|NCT01959139|BG004|Baseline|Total|Total of all reporting groups
10810389|NCT01959139|FG000|Participant Flow|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4|"PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;~Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours;~Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours;~Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours;~5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810390|NCT01959139|FG001|Participant Flow|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only|"PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810391|NCT01959139|FG002|Participant Flow|Phase II: mFOLFIRINOX|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810392|NCT01959139|FG003|Participant Flow|Phase II: mFOLFIRINOX + PEGPH20|"Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810393|NCT01959139|OG000|Outcome|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4|"PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;~Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours;~Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours;~Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours;~5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810394|NCT01959139|OG001|Outcome|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1|"PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810395|NCT01959139|OG002|Outcome|All Phase 1 Participants|Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
10810396|NCT01959139|OG000|Outcome|Phase II: mFOLFIRINOX|"Participants receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810397|NCT01959139|OG001|Outcome|Phase II: mFOLFIRINOX + PEGPH20|"Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes~Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours~Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours~Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours~5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours"
10810398|NCT01959139|OG000|Outcome|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4|PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes__Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810399|NCT01959139|OG001|Outcome|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only|PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810400|NCT01959139|OG002|Outcome|Phase II: mFOLFIRINOX|Participants receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810401|NCT01959139|OG003|Outcome|Phase II: PEGPH20 + mFOLFIRINOX|Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.__PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810402|NCT01959139|EG000|Reported Event|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4|PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes__Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810403|NCT01959139|EG001|Reported Event|Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only|PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810404|NCT01959139|EG002|Reported Event|Phase II: mFOLFIRINOX|Participants receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810405|NCT01959139|EG003|Reported Event|Phase II: PEGPH20 + mFOLFIRINOX|Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.__PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes__Oxaliplatin: 85 mg/m^2, on Day 2, IV over 2 hours__Leucovorin: 400 mg/m^2, on Day 2, IV over 2 hours__Irinotecan: 180 mg/m^2, on Day 2, IV over 1.5 hours__5-fluorouracil: 2,400 mg/m^2, Days 2-4, IV over 46 hours
10810406|NCT01597778|BG000|Baseline|dUCB|"Participants will receive double unrelated cord blood transplant using a reduced intensity conditioning regimen.~Double unrelated cord blood Transplant: The conditioning regimen consists of:~Fludarabine 40 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide 50 mg/kg IV Day -6~Total Body Irradiation (TBI): - 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the last 3 months or an autologous transplant within 24 months of enrollment; - 300 cGY Day -1 for patients who have not received cytotoxic chemotherapy within 3 months of enrollment or an autologous transplant within 24 months of enrollment~Day 0 will be the day of the double UCB transplant~The GVHD prophylaxis regimen consists of:~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Tacrolimus (trough level of 5-15 ng/mL) may be substituted for cyclosporine if the patient is intolerant of cyclosporine or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po TID, maximum dose 1 g po TID beginning Day-3 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 1 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810407|NCT01597778|BG001|Baseline|Haplo-BM|"Participants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.~Haploidentical Bone Marrow Transplant: The conditioning regimen consists of:~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5~Total body irradiation (TBI) 200cGy Day -1~Day 0 will be the day of infusion of non-T-cell depleted bone marrow~The GVHD prophylaxis regimen consists of:~Cy 50 mg/kg IV Days 3, 4~Tacrolimus (IV or PO) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL. Cyclosporine (trough level of 200-400 ng/mL) may be substituted for tacrolimus if the patient is intolerant of tacrolimus or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 5 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810408|NCT01597778|BG002|Baseline|Total|Total of all reporting groups
10810409|NCT01597778|FG000|Participant Flow|dUCB|"Participants will receive double unrelated cord blood transplant using a reduced intensity conditioning regimen.~Double unrelated cord blood Transplant: The conditioning regimen consists of:~Fludarabine 40 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide 50 mg/kg IV Day -6~Total Body Irradiation (TBI): - 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the last 3 months or an autologous transplant within 24 months of enrollment; - 300 cGY Day -1 for patients who have not received cytotoxic chemotherapy within 3 months of enrollment or an autologous transplant within 24 months of enrollment~Day 0 will be the day of the double UCB transplant~The GVHD prophylaxis regimen consists of:~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Tacrolimus (trough level of 5-15 ng/mL) may be substituted for cyclosporine if the patient is intolerant of cyclosporine or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po TID, maximum dose 1 g po TID beginning Day-3 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 1 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810410|NCT01597778|FG001|Participant Flow|Haplo-BM|"Participants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.~Haploidentical Bone Marrow Transplant: The conditioning regimen consists of:~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5~Total body irradiation (TBI) 200cGy Day -1~Day 0 will be the day of infusion of non-T-cell depleted bone marrow~The GVHD prophylaxis regimen consists of:~Cy 50 mg/kg IV Days 3, 4~Tacrolimus (IV or PO) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL. Cyclosporine (trough level of 200-400 ng/mL) may be substituted for tacrolimus if the patient is intolerant of tacrolimus or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 5 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810411|NCT01597778|OG000|Outcome|dUCB|"Participants will receive double unrelated cord blood transplant using a reduced intensity conditioning regimen.~Double unrelated cord blood Transplant: The conditioning regimen consists of:~Fludarabine 40 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide 50 mg/kg IV Day -6~Total Body Irradiation (TBI): - 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the last 3 months or an autologous transplant within 24 months of enrollment; - 300 cGY Day -1 for patients who have not received cytotoxic chemotherapy within 3 months of enrollment or an autologous transplant within 24 months of enrollment~Day 0 will be the day of the double UCB transplant~The GVHD prophylaxis regimen consists of:~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Tacrolimus (trough level of 5-15 ng/mL) may be substituted for cyclosporine if the patient is intolerant of cyclosporine or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po TID, maximum dose 1 g po TID beginning Day-3 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 1 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10821492|NCT00068601|OG001|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
10810412|NCT01597778|OG001|Outcome|Haplo-BM|"Participants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.~Haploidentical Bone Marrow Transplant: The conditioning regimen consists of:~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5~Total body irradiation (TBI) 200cGy Day -1~Day 0 will be the day of infusion of non-T-cell depleted bone marrow~The GVHD prophylaxis regimen consists of:~Cy 50 mg/kg IV Days 3, 4~Tacrolimus (IV or PO) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL. Cyclosporine (trough level of 200-400 ng/mL) may be substituted for tacrolimus if the patient is intolerant of tacrolimus or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 5 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810413|NCT01597778|EG000|Reported Event|dUCB|"Participants will receive double unrelated cord blood transplant using a reduced intensity conditioning regimen.~Double unrelated cord blood Transplant: The conditioning regimen consists of:~Fludarabine 40 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide 50 mg/kg IV Day -6~Total Body Irradiation (TBI): - 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the last 3 months or an autologous transplant within 24 months of enrollment; - 300 cGY Day -1 for patients who have not received cytotoxic chemotherapy within 3 months of enrollment or an autologous transplant within 24 months of enrollment~Day 0 will be the day of the double UCB transplant~The GVHD prophylaxis regimen consists of:~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Tacrolimus (trough level of 5-15 ng/mL) may be substituted for cyclosporine if the patient is intolerant of cyclosporine or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po TID, maximum dose 1 g po TID beginning Day-3 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 1 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
10810414|NCT01597778|EG001|Reported Event|Haplo-BM|"Participants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.~Haploidentical Bone Marrow Transplant: The conditioning regimen consists of:~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2~Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5~Total body irradiation (TBI) 200cGy Day -1~Day 0 will be the day of infusion of non-T-cell depleted bone marrow~The GVHD prophylaxis regimen consists of:~Cy 50 mg/kg IV Days 3, 4~Tacrolimus (IV or PO) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL. Cyclosporine (trough level of 200-400 ng/mL) may be substituted for tacrolimus if the patient is intolerant of tacrolimus or per institutional practice.~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35~Supportive care includes:~- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 5 until ANC >1500/mm3 for 3 consecutive measurements on at least two different days"
11205679|NCT02230579|FG003|Participant Flow|Cohort SAD4 Fasted|"80mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205680|NCT02230579|FG004|Participant Flow|Cohort SAD5 Fasted|"120mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205681|NCT02230579|FG005|Participant Flow|Cohort SAD6 Fed|"Reusing volunteers from one of the previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability.~40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Placebo: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205682|NCT02230579|FG006|Participant Flow|Placebo|"Placebo to match MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose Two volunteers within each cohort (SAD1 to SAD6) were scheduled to receive placebo in a double blind manner."
11205683|NCT02230579|OG000|Outcome|Cohort SAD1 Fasted|"5mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205684|NCT02230579|OG001|Outcome|Cohort SAD2 Fasted|"20mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205685|NCT02230579|OG002|Outcome|Cohort SAD3 Fasted|"40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10821493|NCT00068601|EG000|Reported Event|Standard Chemotherapy|Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen
11205686|NCT02230579|OG003|Outcome|Cohort SAD4 Fasted|"80mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810440|NCT01134601|BG000|Baseline|Selumetinib (AZD6244): 50 mg & Capecitabine: 825 mg/m^2|"LEVEL 1 - Cycle = 49 days: AZD6244: 50 mg by mouth (PO) everyday (QD) Capecitabine: 825 mg/m^2 by mouth (PO)~Radiation Therapy~Capecitabine~AZD6244"
10810441|NCT01134601|FG000|Participant Flow|Selumetinib (AZD6244): 50 mg & Capecitabine: 825 mg/m^2|"LEVEL 1 - Cycle = 49 days: AZD6244: 50 mg by mouth (PO) everyday (QD) Capecitabine: 825 mg/m^2 by mouth (PO)~Radiation Therapy~Capecitabine~AZD6244"
10810442|NCT01134601|OG000|Outcome|Selumetinib (AZD6244): 50 mg & Capecitabine: 825 mg/m^2|"LEVEL 1 - Cycle = 49 days: AZD6244: 50 mg by mouth (PO) everyday (QD) Capecitabine: 825 mg/m^2 by mouth (PO)~Radiation Therapy~Capecitabine~AZD6244"
10810443|NCT01134601|EG000|Reported Event|Selumetinib (AZD6244): 50 mg & Capecitabine: 825 mg/m^2|"LEVEL 1 - Cycle = 49 days: AZD6244: 50 mg by mouth (PO) everyday (QD) Capecitabine: 825 mg/m^2 by mouth (PO)~Radiation Therapy~Capecitabine~AZD6244"
10810444|NCT01118026|BG000|Baseline|ABVD +/- BEACOPP + Radiation|"Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. > > Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). >~> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).>~> All patients will be followed for a maximum of ten years.>~> ABVD: doxorubicin 25 mg/m^2 IV> bleomycin 10 units/m^2 IV> vinblastine 6 mg/m^2 IV> dacarbazine 375 mg/m^2 IV>~> BEACOPP: bleomycin 10 units/m^2 IV on Day 8> etoposide 200 mg/m^2 IV on Days 1, 2 and 3> doxorubicin 35 mg/m^2 IV on Day 1> cyclophosphamide 1250 mg/m^2 IV on Day 1> vincristine 1.4 mg/m^2 IV on Day 8> procarbazine 100 mg/m^2 orally on Days 1-7> prednisone 40 mg/m^2 orally on Days 1-14>~> radiation therapy"
10810445|NCT01118026|FG000|Participant Flow|ABVD +/- BEACOPP + Radiation|"Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. > > Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). >~> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).>~> All patients will be followed for a maximum of ten years.>~> ABVD: doxorubicin 25 mg/m^2 IV> bleomycin 10 units/m^2 IV> vinblastine 6 mg/m^2 IV> dacarbazine 375 mg/m^2 IV>~> BEACOPP: bleomycin 10 units/m^2 IV on Day 8> etoposide 200 mg/m^2 IV on Days 1, 2 and 3> doxorubicin 35 mg/m^2 IV on Day 1> cyclophosphamide 1250 mg/m^2 IV on Day 1> vincristine 1.4 mg/m^2 IV on Day 8> procarbazine 100 mg/m^2 orally on Days 1-7> prednisone 40 mg/m^2 orally on Days 1-14>~> radiation therapy"
10810446|NCT01118026|OG000|Outcome|ABVD (PET-negative)|"Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. > > Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). >~>~> All patients will be followed for a maximum of ten years.>~> ABVD: doxorubicin 25 mg/m^2 IV> bleomycin 10 units/m^2 IV> vinblastine 6 mg/m^2 IV> dacarbazine 375 mg/m^2 IV"
10810447|NCT01118026|OG001|Outcome|ABVD + BEACOPP + Radiation (PET-positive)|"Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. > > Patients undergo a PET scan following two cycles of ABVD. If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). >~> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).>~> All patients will be followed for a maximum of ten years.>~> ABVD: doxorubicin 25 mg/m^2 IV> bleomycin 10 units/m^2 IV> vinblastine 6 mg/m^2 IV> dacarbazine 375 mg/m^2 IV>~> BEACOPP: bleomycin 10 units/m^2 IV on Day 8> etoposide 200 mg/m^2 IV on Days 1, 2 and 3> doxorubicin 35 mg/m^2 IV on Day 1> cyclophosphamide 1250 mg/m^2 IV on Day 1> vincristine 1.4 mg/m^2 IV on Day 8> procarbazine 100 mg/m^2 orally on Days 1-7> prednisone 40 mg/m^2 orally on Days 1-14>~> radiation therapy"
10810448|NCT01118026|EG000|Reported Event|ABVD +/- BEACOPP + Radiation|radiation therapy
10810449|NCT00879086|BG000|Baseline|Eribulin Mesylate|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810450|NCT00879086|BG001|Baseline|Ixabepilone|Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810451|NCT00879086|BG002|Baseline|Total|Total of all reporting groups
10810452|NCT00879086|FG000|Participant Flow|Eribulin Mesylate|Eribulin mesylate was given at a dose of 1.4 milligram per square meter (mg/m^2) as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810453|NCT00879086|FG001|Participant Flow|Ixabepilone|Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810454|NCT00879086|OG000|Outcome|Eribulin Mesylate|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810455|NCT00879086|OG001|Outcome|Ixabepilone|Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810456|NCT00879086|EG000|Reported Event|Eribulin Mesylate|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 minute IV bolus on Days 1 and 8 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810457|NCT00879086|EG001|Reported Event|Ixabepilone|Ixabepilone was given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle during the Treatment and Extension Phases. The Treatment Phase included six cycles. Following the sixth cycle of the Treatment Phase, participants who demonstrated clinical benefit could continue treatment during the Extension Phase for an indefinite number of cycles for as long as clinical benefit was sustained (up to 211 weeks).
10810458|NCT00864227|BG000|Baseline|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
10810459|NCT00864227|FG000|Participant Flow|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
10810460|NCT00864227|OG000|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
10810461|NCT00864227|EG000|Reported Event|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
10821494|NCT00068601|EG001|Reported Event|Chemotherapy Plus Goserelin|Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
10810480|NCT00685360|BG000|Baseline|Delamanid 100 mg BID + OBR|"Participants received delamanid 100 mg (two 50 mg tablets), orally, BID with two matching placebo tablets plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810481|NCT00685360|BG001|Baseline|Delamanid 200 mg BID + OBR|"Participants received delamanid 200 mg (four 50 mg tablets), orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810482|NCT00685360|BG002|Baseline|Placebo + OBR|"Participants received four placebo tablets matching 50-mg tablets of delamanid, orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810483|NCT00685360|BG003|Baseline|Total|Total of all reporting groups
10810484|NCT00685360|FG000|Participant Flow|Delamanid 100 mg BID + OBR|"Participants received delamanid 100 mg (two 50 mg tablets), orally, twice daily (BID) with two matching placebo tablets plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on World Health Organization (WHO) guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810485|NCT00685360|FG001|Participant Flow|Delamanid 200 mg BID + OBR|"Participants received delamanid 200 mg (four 50 mg tablets), orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810486|NCT00685360|FG002|Participant Flow|Placebo + OBR|"Participants received four placebo tablets matching 50-mg tablets of delamanid, orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810487|NCT00685360|OG000|Outcome|Delamanid 100 mg BID + OBR|"Participants received delamanid 100 mg (two 50 mg tablets), orally, BID with two matching placebo tablets plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810488|NCT00685360|OG001|Outcome|Delamanid 200 mg BID + OBR|"Participants received delamanid 200 mg (four 50 mg tablets), orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810489|NCT00685360|OG002|Outcome|Placebo + OBR|"Participants received four placebo tablets matching 50-mg tablets of delamanid, orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810490|NCT00685360|EG000|Reported Event|Delamanid 100 mg BID + OBR|"Participants received delamanid 100 mg (two 50 mg tablets), orally, BID with two matching placebo tablets plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810491|NCT00685360|EG001|Reported Event|Delamanid 200 mg BID + OBR|"Participants received delamanid 200 mg (four 50 mg tablets), orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810492|NCT00685360|EG002|Reported Event|Placebo + OBR|"Participants received four placebo tablets matching 50-mg tablets of delamanid, orally, BID plus OBR for 56 consecutive days (from Day 1 to Day 56).~Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment, in conjunction with national TB program guidelines in each country."
10810493|NCT00299728|BG000|Baseline|Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810494|NCT00299728|BG001|Baseline|Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810495|NCT00299728|BG002|Baseline|Total|Total of all reporting groups
10810496|NCT00299728|FG000|Participant Flow|Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810497|NCT00299728|FG001|Participant Flow|Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810498|NCT00299728|OG000|Outcome|Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810499|NCT00299728|OG001|Outcome|Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810500|NCT00299728|EG000|Reported Event|Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10810501|NCT00299728|EG001|Reported Event|Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG|400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
10821495|NCT00068692|BG000|Baseline|Irinocetan (Arm I)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin,
10821496|NCT00068692|BG001|Baseline|Oxaliplatin (Arm II)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
10821497|NCT00068692|BG002|Baseline|Control (Arm III)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
10821498|NCT00068692|BG003|Baseline|Total|Total of all reporting groups
10821499|NCT00068692|FG000|Participant Flow|Group I, Arm S|Group I patients receive concurrent chemotherapy and radiation prior to surgery.
10821500|NCT00068692|FG001|Participant Flow|Group II, Arm T|Patients who had surgery before registering to the study was in Group II. They were registered and randomized at the same time.
10821501|NCT00068692|FG002|Participant Flow|Group I, Arm I|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV~Irinotecan: Given IV"
10821502|NCT00068692|FG003|Participant Flow|Group I, Arm II|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV~Oxaliplatin: Given IV"
10821503|NCT00068692|FG004|Participant Flow|Group I, Arm III|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV"
10810532|NCT04450823|BG000|Baseline|All Participants of the Study|Included were English speaking experienced members of foreign teams and local team members from LMIC, that did participate in at least one short-term surgical mission in a hospital in a LMIC.
10810533|NCT04450823|FG000|Participant Flow|Experts|Included were English speaking experienced members of foreign teams and local team members from LMIC, that did participate in at least one short-term surgical mission in a hospital in a LMIC.
10810534|NCT04450823|OG000|Outcome|All Included Participants of the Study|Included were English speaking experienced members of foreign teams and local team members from LMIC, that did participate in at least one short-term surgical mission in a hospital in a LMIC.
10810535|NCT04450823|EG000|Reported Event|Experts|Included were English speaking experienced members of foreign teams and local team members from LMIC, that did participate in at least one short-term surgical mission in a hospital in a LMIC.
10810536|NCT04446247|BG000|Baseline|ARMS SpO2 70-100%|Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
10810537|NCT04446247|FG000|Participant Flow|ARMS SpO2 70-100%|Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
10810538|NCT04446247|OG000|Outcome|ARMS SpO2 70-100%, Oximeter #1 (Left)|Comparison to Reference CO-Oximetry on the left thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
10810539|NCT04446247|OG001|Outcome|ARMS SpO2 70-100%, Oximeter #2 (Right)|"Comparison to Reference CO-Oximetry on the right thumb.~Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less."
10810540|NCT04446247|EG000|Reported Event|ARMS SpO2 70-100%, Oximeter #1 (Left)|Comparison to Reference CO-Oximetry on the left thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
10810541|NCT04446247|EG001|Reported Event|ARMS SpO2 70-100%, Oximeter #2 (Right)|"Comparison to Reference CO-Oximetry on the left thumb.~Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less."
10810542|NCT04386785|BG000|Baseline|Single-arm: Endovascular Thermal Ablation in IPV|Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
10810543|NCT04386785|FG000|Participant Flow|Single-arm: Endovascular Thermal Ablation in IPV|Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
10810544|NCT04386785|OG000|Outcome|Single-arm: Endovascular Thermal Ablation in IPV|Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
10810545|NCT04386785|EG000|Reported Event|Single-arm: Endovascular Thermal Ablation in IPV|Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins: The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
10810546|NCT04347564|BG000|Baseline|Initial Population|As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the pseudonymised questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
10810547|NCT04347564|FG000|Participant Flow|Initial Population|As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June, 2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain optical coherence tomography was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test or they could download the test as an app for use with an iPad or smartphone (MacuFix group). 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI VFQ-25 once more.
10810548|NCT04347564|OG000|Outcome|Initial Population|As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
10810549|NCT04347564|OG000|Outcome|Initial Population|As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI VFQ-25 once more.
10810550|NCT04347564|OG000|Outcome|App-users|12-14 weeks after the study day patients using MacuFix® as a home test were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
10810551|NCT04347564|OG001|Outcome|Amsler Grid or no Home Test|12-14 weeks after the study day patients using the Amsler Grid as a home test or no home test were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
10810552|NCT04347564|EG000|Reported Event|Initial Population|As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the pseudonymised questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
10821504|NCT00068692|FG005|Participant Flow|Group II, Arm I|"Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.~Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV~Irinotecan: Given IV"
10821505|NCT00068692|FG006|Participant Flow|Group II, Arm II|"Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.~Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV~Oxaliplatin: Given IV"
10821506|NCT00068692|FG007|Participant Flow|Group II, Arm III|"Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy~Fluorouracil: Given IV~Leucovorin Calcium: Given IV"
10821507|NCT00068692|OG000|Outcome|Irinocetan (Arm I)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.
10821508|NCT00068692|OG001|Outcome|Oxaliplatin (Arm II)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
10821509|NCT00068692|OG002|Outcome|Control (Arm III)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
10810553|NCT04330157|BG000|Baseline|Demographic Characteristics of the Patients|Demographic characteristics of the patients included and type of surgical procedures
10810554|NCT04330157|FG000|Participant Flow|Patients Included in the Study|The study included patients admitted to the ICU after major abdominal surgeries.
10810555|NCT04330157|OG000|Outcome|NRS Score Before Tramadol Application|Before administration of tramadol to all patients who were extubated an NRS score was determined
10810556|NCT04330157|OG001|Outcome|NRS Score After Tramadol Application|30 minutes after administration of tramadol to all patients who were extubated an NRS score was determined
10810557|NCT04330157|OG000|Outcome|NRS Before Tramadol - no Systemic Inflammation|NRS score in a patient who did not meet the criteria for systemic inflammation, before tramadol administration
10810558|NCT04330157|OG001|Outcome|NRS After Tramadol - no Systemic Inflammation|NRS score in a patient who did not meet the criteria for systemic inflammation, after tramadol administration
10810559|NCT04330157|OG002|Outcome|NRS Before Tramadol - With Systemic Inflammation|NRS score in a patient who meet the criteria for systemic inflammation, before tramadol administration
10810560|NCT04330157|OG003|Outcome|NRS After Tramadol - With Systemic Inflammation|NRS score in a patient who meet the criteria for systemic inflammation, after tramadol administration
10810561|NCT04330157|EG000|Reported Event|Adverse Effect|Adverse effect of tramadol
10821510|NCT00068692|OG001|Outcome|Oxaliplatin (Arm II)|The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined.Patients in this group received oxaliplatin plus 5-FU and leucovorin.
10821511|NCT00068692|EG000|Reported Event|Arm S|Preoperative chemo/radiation therapy received by Group I patients in step 1
10821512|NCT00068692|EG001|Reported Event|Group I, Arm I|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV"
10821513|NCT00068692|EG002|Reported Event|Group I, Arm II|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV"
10821514|NCT00068692|EG003|Reported Event|Group I, Arm III|"Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV"
10821515|NCT00068692|EG004|Reported Event|Group II, Arm I|"Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.~Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV"
10821516|NCT00068692|EG005|Reported Event|Group II, Arm II|"Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.~Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV"
10821517|NCT00068692|EG006|Reported Event|Group II, Arm III|"Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.~Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV"
10821518|NCT00068718|BG000|Baseline|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
10821519|NCT00068718|FG000|Participant Flow|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
10821520|NCT00068718|OG000|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
11205687|NCT02230579|OG004|Outcome|Cohort SAD5 Fasted|"120mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810562|NCT04317690|BG000|Baseline|High Cholesterol|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
10810563|NCT04317690|BG001|Baseline|High Blood Pressure|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
10810564|NCT04317690|BG002|Baseline|Colorectal Cancer Screening|People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
10810565|NCT04317690|BG003|Baseline|Breast Cancer Screening|Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
10810566|NCT04317690|BG004|Baseline|Prostate Cancer Screening|Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
10810567|NCT04317690|BG005|Baseline|Total|Total of all reporting groups
10810568|NCT04317690|FG000|Participant Flow|High Cholesterol|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
10810569|NCT04317690|FG001|Participant Flow|High Blood Pressure|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
10810570|NCT04317690|FG002|Participant Flow|Colorectal Cancer Screening|People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
10810571|NCT04317690|FG003|Participant Flow|Breast Cancer Screening|Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
10810572|NCT04317690|FG004|Participant Flow|Prostate Cancer Screening|Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
10810573|NCT04317690|OG000|Outcome|High Cholesterol|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
10810574|NCT04317690|OG001|Outcome|High Blood Pressure|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
10810575|NCT04317690|OG002|Outcome|Colorectal Cancer Screening|People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
10810576|NCT04317690|OG003|Outcome|Breast Cancer Screening|Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
10810577|NCT04317690|OG004|Outcome|Prostate Cancer Screening|Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
10810578|NCT04317690|EG000|Reported Event|High Cholesterol|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
10810579|NCT04317690|EG001|Reported Event|High Blood Pressure|People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
10810580|NCT04317690|EG002|Reported Event|Colorectal Cancer Screening|People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
11244304|NCT02510001|BG004|Baseline|Dose Escalation Phase 5.|"Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10810581|NCT04317690|EG003|Reported Event|Breast Cancer Screening|Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
10810582|NCT04317690|EG004|Reported Event|Prostate Cancer Screening|Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
10821521|NCT00068718|EG000|Reported Event|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
10821522|NCT00068770|BG000|Baseline|p450 ( +EIASD)|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
10821523|NCT00068770|BG001|Baseline|nonp450 (-EIASD)|not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
10821524|NCT00068770|BG002|Baseline|Total|Total of all reporting groups
10821525|NCT00068770|FG000|Participant Flow|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
10821526|NCT00068770|FG001|Participant Flow|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
10821527|NCT00068770|OG000|Outcome|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
10821528|NCT00068770|OG001|Outcome|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
10821529|NCT00068770|OG000|Outcome|p450 ( +EIASD)|"on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
10821530|NCT00068770|OG001|Outcome|nonp450 (-EIASD)|"not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
10821531|NCT00068770|EG000|Reported Event|P450 ARM|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
10821532|NCT00068770|EG001|Reported Event|Non P450 ARM|NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra.
10821533|NCT00068822|BG000|Baseline|Vertebroplasty|Participants will receive percutaneous vertebroplasty
10821534|NCT00068822|BG001|Baseline|Control Group|Participants will receive partial vertebroplasty without PMMA
10821535|NCT00068822|BG002|Baseline|Total|Total of all reporting groups
10821536|NCT00068822|FG000|Participant Flow|Vertebroplasty, Then Control|Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
10821537|NCT00068822|FG001|Participant Flow|Control, Then Vertebroplasty|Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture).
10821538|NCT00068822|OG000|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
10821539|NCT00068822|OG001|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
10821540|NCT00068822|EG000|Reported Event|Vertebroplasty|Participants will receive percutaneous vertebroplasty
10821541|NCT00068822|EG001|Reported Event|Control Group|Participants will receive partial vertebroplasty without PMMA
10821542|NCT00069095|BG000|Baseline|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10847596|NCT00284050|EG001|Reported Event|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
10810583|NCT04274556|BG000|Baseline|Post-dialysis Recovery Group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account
10810584|NCT04274556|FG000|Participant Flow|Post-dialysis Recovery Group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account
10810585|NCT04274556|OG000|Outcome|Post-dialysis Recovery Group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account
10810586|NCT04274556|EG000|Reported Event|Post-dialysis Recovery Group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account
10810587|NCT04270292|BG000|Baseline|Arteriovenous Fistula Cannulation Group|The cannulation practices' of patients was asked to the nurses and patients.
10810588|NCT04270292|FG000|Participant Flow|Arteriovenous Fistula Cannulation Group|The cannulation practices' of patients was asked to the nurses and patients.
10810589|NCT04270292|OG000|Outcome|Arteriovenous Fistula Cannulation Group|The cannulation practices' of patients was asked to the nurses and patients.
10810590|NCT04270292|EG000|Reported Event|Arteriovenous Fistula Cannulation Group|The cannulation practices' of patients was asked to the nurses and patients.
10810591|NCT04182217|BG000|Baseline|Population|The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate).
10810592|NCT04182217|FG000|Participant Flow|Population|The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate).
10810593|NCT04182217|OG000|Outcome|Population|The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate).
10810594|NCT04182217|EG000|Reported Event|Population|The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate).
10810595|NCT04160988|BG000|Baseline|Intended Use Population|Intended Use Population
10810596|NCT04160988|FG000|Participant Flow|Test Group|A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population.
10810597|NCT04160988|OG000|Outcome|Intended Use Population|Intended Use Population
10810598|NCT04160988|OG000|Outcome|Test Group|A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population.
10810599|NCT04160988|EG000|Reported Event|Test Group|A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population.
10810600|NCT04083404|BG000|Baseline|Enhanced IPS Programme|An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation
11244305|NCT02510001|BG005|Baseline|Dose Escalation Phase Dose 5a|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10810601|NCT04083404|FG000|Participant Flow|Enhanced Individual Placement and Support (IPS) Programme|An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation
10810602|NCT04083404|OG000|Outcome|Enhanced IPS Programme|An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation
10810603|NCT04083404|EG000|Reported Event|Enhanced IPS Programme|An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation
11205688|NCT02230579|OG005|Outcome|Cohort SAD6 Fed|"Cohort SAD6, reusing volunteers from previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability~40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205689|NCT02230579|OG006|Outcome|Placebo|"Placebo to match MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose~Two volunteers within each cohort (SAD1 to SAD6) were scheduled to receive placebo in a double blind manner."
11205690|NCT02230579|EG000|Reported Event|Cohort SAD1 Fasted|"5mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205691|NCT02230579|EG001|Reported Event|Cohort SAD2 Fasted|"20mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205692|NCT02230579|EG002|Reported Event|Cohort SAD3 Fasted|"40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205693|NCT02230579|EG003|Reported Event|Cohort SAD4 Fasted|"80mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
11205694|NCT02230579|EG004|Reported Event|Cohort SAD5 Fasted|"120mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810604|NCT04079114|BG000|Baseline|Patients Who Received the Stafit Acetabular System|Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
10810605|NCT04079114|FG000|Participant Flow|Patients Who Received the Stafit Acetabular System|Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
10810606|NCT04079114|OG000|Outcome|Patients Who Received the Stafit Acetabular System|Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
11205695|NCT02230579|EG005|Reported Event|Cohort SAD6 Fed|"Cohort SAD6, reusing volunteers from previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability 40mg of MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose"
10810607|NCT04079114|EG000|Reported Event|Patients Who Received the Stafit Acetabular System|Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
10810608|NCT04075279|BG000|Baseline|Research Study Participation|Participants who were enrolled in the study and completed all study procedures.
10810609|NCT04075279|FG000|Participant Flow|Middle-aged Males in High Activity Occupations|All participants were enrolled into a single arm and all comparisons were made within subjects.
10810610|NCT04075279|OG000|Outcome|Research Study Participation|Participants who were enrolled in the study and completed all study procedures.
11205696|NCT02230579|EG006|Reported Event|Placebo|"Placebo to match MMV390048: Single administration, supplied as powder in bottle formulation for reconstitution pre-dose Two volunteers within each cohort (SAD1 to SAD6) were scheduled to receive placebo in a double blind manner."
11205697|NCT02230670|BG000|Baseline|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
11205698|NCT02230670|BG001|Baseline|Placebo|"Placebo BID~Placebo"
11205699|NCT02230670|BG002|Baseline|Total|Total of all reporting groups
11205700|NCT02230670|FG000|Participant Flow|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
11205701|NCT02230670|FG001|Participant Flow|Placebo|"Placebo BID~Placebo"
11205702|NCT02230670|OG000|Outcome|IDN-6556|"25 mg BID of IDN-6556~IDN-6556: 25 mg BID"
11205703|NCT02230670|OG001|Outcome|Placebo|"Placebo BID~Placebo"
11205704|NCT02230670|EG000|Reported Event|IDN-6556 (Baseline-Month 3)|25 mg BID of IDN-6556 (Baseline-Month 3).
11205705|NCT02230670|EG001|Reported Event|Placebo (Baseline-Month 3)|Placebo BID (Baseline-Month 3)
11205706|NCT02230683|BG000|Baseline|IDN-6556|IDN-6556 25 mg Dosed twice daily
11205707|NCT02230683|FG000|Participant Flow|IDN-6556|IDN-6556 25 mg Dosed twice daily
11205708|NCT02230683|OG000|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
11205709|NCT02230683|OG001|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
11205710|NCT02230683|OG002|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
11205711|NCT02230683|OG000|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
11205712|NCT02230683|OG001|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with Baseline HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
11205713|NCT02230683|OG002|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
11205714|NCT02230683|OG000|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
11205715|NCT02230683|EG000|Reported Event|IDN-6556|IDN-6556 25 mg Dosed twice daily
11205716|NCT02230696|BG000|Baseline|Test Product|"Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray~Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate"
11205717|NCT02230696|BG001|Baseline|Reference Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
11205718|NCT02230696|BG002|Baseline|Placebo Product|"Placebo nasal spray~Placebo nasal spray"
11205719|NCT02230696|BG003|Baseline|Total|Total of all reporting groups
11205720|NCT02230696|FG000|Participant Flow|Test Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo
11205721|NCT02230696|FG001|Participant Flow|Reference Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Meda
11205722|NCT02230696|FG002|Participant Flow|Placebo Product|Placebo nasal spray
11205723|NCT02230696|OG000|Outcome|Test Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo
10810611|NCT04075279|EG000|Reported Event|Research Study Participation|Participants who were enrolled in the study and completed all study procedures.
10821543|NCT00069095|BG001|Baseline|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821544|NCT00069095|BG002|Baseline|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821545|NCT00069095|BG003|Baseline|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821546|NCT00069095|BG004|Baseline|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821547|NCT00069095|BG005|Baseline|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821548|NCT00069095|BG006|Baseline|Total|Total of all reporting groups
10821549|NCT00069095|FG000|Participant Flow|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821550|NCT00069095|FG001|Participant Flow|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
11244306|NCT02510001|BG006|Baseline|Dose Expansion Phase|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10810612|NCT04066686|BG000|Baseline|Young|Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
10810613|NCT04066686|BG001|Baseline|Elderly|Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
10810614|NCT04066686|BG002|Baseline|Total|Total of all reporting groups
10810615|NCT04066686|FG000|Participant Flow|Young|Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
10810616|NCT04066686|FG001|Participant Flow|Elderly|Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
10810617|NCT04066686|OG000|Outcome|Young|Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
10810618|NCT04066686|OG001|Outcome|Elderly|Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
10810619|NCT04066686|EG000|Reported Event|Young|Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
10810620|NCT04066686|EG001|Reported Event|Elderly|Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
10810621|NCT04058626|BG000|Baseline|Study Participants|Participants with diabetes were consecutively enrolled into the study across 2 centers.
11205724|NCT02230696|OG001|Outcome|Reference Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda
11205725|NCT02230696|OG002|Outcome|Placebo Nasal Spray|Placebo nasal spray
10810622|NCT04058626|FG000|Participant Flow|Study Participants|Participants with diabetes were consecutively enrolled into the study across 2 centers.
10810623|NCT04058626|OG000|Outcome|Study Participants|Participants with diabetes were consecutively enrolled into the study across 2 centers.
10810624|NCT04058626|EG000|Reported Event|Study Participants|Participants with diabetes were consecutively enrolled into the study across 2 centers.
10810625|NCT04057235|BG000|Baseline|Single Retrospective Study Arm|Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
10810626|NCT04057235|FG000|Participant Flow|Single Retrospective Study Arm|Participants who previously underwent Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) surgery with the FlareHawk® expandable interbody fusion device.
10810627|NCT04057235|OG000|Outcome|Single Retrospective Study Arm|Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
10810628|NCT04057235|EG000|Reported Event|Single Retrospective Study Arm|Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
10821551|NCT00069095|FG002|Participant Flow|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821552|NCT00069095|FG003|Participant Flow|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10847597|NCT00284050|EG002|Reported Event|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
11205726|NCT02230696|EG000|Reported Event|Test Product|"Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray~Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate"
11205727|NCT02230696|EG001|Reported Event|Reference Product|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
11205728|NCT02230696|EG002|Reported Event|Placebo Product|"Placebo nasal spray~Placebo nasal spray"
11205729|NCT02230761|BG000|Baseline|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
11205730|NCT02230761|BG001|Baseline|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
11205731|NCT02230761|BG002|Baseline|Total|Total of all reporting groups
11205732|NCT02230761|FG000|Participant Flow|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
11205733|NCT02230761|FG001|Participant Flow|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
11205734|NCT02230761|OG000|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
11205735|NCT02230761|OG001|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
11205736|NCT02230761|EG000|Reported Event|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
10810629|NCT04041037|BG000|Baseline|All Participants|All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds.
10810630|NCT04041037|FG000|Participant Flow|All Participants|Participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds.
10810631|NCT04041037|OG000|Outcome|All Participants|Participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds.
10810632|NCT04041037|EG000|Reported Event|All Participants|All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to standard of care Negative Pressure Wound Therapy on their pilonidal wounds.
10810633|NCT04034043|BG000|Baseline|THA Post Acetabular Fractures|Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
10810634|NCT04034043|FG000|Participant Flow|THA Post Acetabular Fractures|Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
10810635|NCT04034043|OG000|Outcome|THA Post Acetabular Fractures|Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
10810636|NCT04034043|EG000|Reported Event|THA Post Acetabular Fractures|Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
10821553|NCT00069095|FG004|Participant Flow|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821554|NCT00069095|FG005|Participant Flow|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821555|NCT00069095|OG000|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
10821556|NCT00069095|OG001|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
10821557|NCT00069095|OG000|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
10821558|NCT00069095|OG001|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
11205737|NCT02230761|EG001|Reported Event|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
11205738|NCT02230904|BG000|Baseline|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
10810637|NCT03977818|BG000|Baseline|Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013|Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria
10810638|NCT03977818|FG000|Participant Flow|Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013|Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria
10810639|NCT03977818|OG000|Outcome|Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013|Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria
10810640|NCT03977818|EG000|Reported Event|Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013|Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 satisfying all eligibility criteria
10810641|NCT03976531|BG000|Baseline|National Panel of Experts|National panel of experts involved in the scoring of the items/tools to be included in the G-CODE.
10810642|NCT03976531|FG000|Participant Flow|National Panel of Experts|National panel of experts involved in the scoring of the items/tools to be included in the G-CODE.
10810643|NCT03976531|OG000|Outcome|National Panel of Experts|National panel of experts involved in the scoring of the items/tools to be included in the G-CODE.
10810644|NCT03976531|EG000|Reported Event|National Panel of Experts|National panel of experts involved in the scoring of the items/tools to be included in the G-CODE.
10821559|NCT00069095|EG000|Reported Event|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821560|NCT00069095|EG001|Reported Event|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821561|NCT00069095|EG002|Reported Event|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821562|NCT00069095|EG003|Reported Event|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821563|NCT00069095|EG004|Reported Event|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10847598|NCT00284089|BG000|Baseline|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
10810645|NCT03964649|BG000|Baseline|Tofacitinib XR|Participants who started treatment with modified-release (XR) tofacitinib during identification period were included in this arm.
10810646|NCT03964649|BG001|Baseline|Tofacitinib IR|Participants who started treatment with immediate-release (IR) tofacitinib during identification period were included in this arm.
10810647|NCT03964649|BG002|Baseline|Adalimumab|Participants who started treatment with adalimumab (tumor-necrosis factor-alpha inhibitor [TNFI]) during identification period were included in this arm.
10810648|NCT03964649|BG003|Baseline|Certolizumab Pegol|Participants who started treatment with certolizumab pegol (TNFI) during identification period were included in this arm.
10810649|NCT03964649|BG004|Baseline|Etanercept|Participants who started treatment with etanercept (TNFI) during identification period were included in this arm.
10810650|NCT03964649|BG005|Baseline|Infliximab|Participants who started treatment with infliximab (TNFI) during identification period were included in this arm.
10810651|NCT03964649|BG006|Baseline|Golimumab|Participants who started treatment with golimumab (TNFI) during identification period were included in this arm.
10810652|NCT03964649|BG007|Baseline|Rituximab|Participants who started treatment with rituximab (non-TNFI) during identification period were included in this arm.
10810653|NCT03964649|BG008|Baseline|Tocilizumab|Participants who started treatment with tocilizumab (non-TNFI) during identification period were included in this arm.
10810654|NCT03964649|BG009|Baseline|Abatacept|Participants who started treatment with abatacept (non-TNFI) during identification period were included in this arm.
10810655|NCT03964649|BG010|Baseline|Total|Total of all reporting groups
10810656|NCT03964649|FG000|Participant Flow|Tofacitinib XR|Participants who started treatment with modified-release (XR) tofacitinib during identification period were included in this arm.
10810657|NCT03964649|FG001|Participant Flow|Tofacitinib IR|Participants who started treatment with immediate-release (IR) tofacitinib during identification period were included in this arm.
10810658|NCT03964649|FG002|Participant Flow|Adalimumab|Participants who started treatment with adalimumab (tumor-necrosis factor-alpha inhibitor [TNFI]) during identification period were included in this arm.
10810659|NCT03964649|FG003|Participant Flow|Certolizumab Pegol|Participants who started treatment with certolizumab pegol (TNFI) during identification period were included in this arm.
10810660|NCT03964649|FG004|Participant Flow|Etanercept|Participants who started treatment with etanercept (TNFI) during identification period were included in this arm.
10810661|NCT03964649|FG005|Participant Flow|Infliximab|Participants who started treatment with infliximab (TNFI) during identification period were included in this arm.
10810662|NCT03964649|FG006|Participant Flow|Golimumab|Participants who started treatment with golimumab (TNFI) during identification period were included in this arm.
10810663|NCT03964649|FG007|Participant Flow|Rituximab|Participants who started treatment with rituximab (non-TNFI) during identification period were included in this arm.
10810664|NCT03964649|FG008|Participant Flow|Tocilizumab|Participants who started treatment with tocilizumab (non-TNFI) during identification period were included in this arm.
10810665|NCT03964649|FG009|Participant Flow|Abatacept|Participants who started treatment with abatacept (non-TNFI) during identification period were included in this arm.
10810666|NCT03964649|OG000|Outcome|Tofacitinib XR|Participants who started treatment with modified-release (XR) tofacitinib during identification period were included in this arm.
10810667|NCT03964649|OG001|Outcome|Tofacitinib IR|Participants who started treatment with immediate-release (IR) tofacitinib during identification period were included in this arm.
10810668|NCT03964649|OG002|Outcome|Adalimumab|Participants who started treatment with adalimumab (tumor-necrosis factor-alpha inhibitor [TNFI]) during identification period were included in this arm.
10810669|NCT03964649|OG003|Outcome|Certolizumab Pegol|Participants who started treatment with certolizumab pegol (TNFI) during identification period were included in this arm.
10810670|NCT03964649|OG004|Outcome|Etanercept|Participants who started treatment with etanercept (TNFI) during identification period were included in this arm.
10810671|NCT03964649|OG005|Outcome|Infliximab|Participants who started treatment with infliximab (TNFI) during identification period were included in this arm.
10810672|NCT03964649|OG006|Outcome|Golimumab|Participants who started treatment with golimumab (TNFI) during identification period were included in this arm.
10810673|NCT03964649|OG007|Outcome|Rituximab|Participants who started treatment with rituximab (non-TNFI) during identification period were included in this arm.
10810674|NCT03964649|OG008|Outcome|Tocilizumab|Participants who started treatment with tocilizumab (non-TNFI) during identification period were included in this arm.
10810675|NCT03964649|OG009|Outcome|Abatacept|Participants who started treatment with abatacept (non-TNFI) during identification period were included in this arm.
10810676|NCT03964649|EG000|Reported Event|Tofacitinib XR|Participants who started treatment with modified-release (XR) tofacitinib during identification period were included in this arm.
10810677|NCT03964649|EG001|Reported Event|Tofacitinib IR|Participants who started treatment with immediate-release (IR) tofacitinib during identification period were included in this arm.
10810678|NCT03964649|EG002|Reported Event|Adalimumab|Participants who started treatment with adalimumab (tumor-necrosis factor-alpha inhibitor [TNFI]) during identification period were included in this arm.
10810679|NCT03964649|EG003|Reported Event|Certolizumab Pegol|Participants who started treatment with certolizumab pegol (TNFI) during identification period were included in this arm.
10810680|NCT03964649|EG004|Reported Event|Etanercept|Participants who started treatment with etanercept (TNFI) during identification period were included in this arm.
10810681|NCT03964649|EG005|Reported Event|Infliximab|Participants who started treatment with infliximab (TNFI) during identification period were included in this arm.
10810682|NCT03964649|EG006|Reported Event|Golimumab|Participants who started treatment with golimumab (TNFI) during identification period were included in this arm.
10810683|NCT03964649|EG007|Reported Event|Rituximab|Participants who started treatment with rituximab (non-TNFI) during identification period were included in this arm.
10810684|NCT03964649|EG008|Reported Event|Tocilizumab|Participants who started treatment with tocilizumab (non-TNFI) during identification period were included in this arm.
10810685|NCT03964649|EG009|Reported Event|Abatacept|Participants who started treatment with abatacept (non-TNFI) during identification period were included in this arm.
10821564|NCT00069095|EG005|Reported Event|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
10821565|NCT00069108|BG000|Baseline|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
10821566|NCT00069108|BG001|Baseline|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
10821567|NCT00069108|BG002|Baseline|Total|Total of all reporting groups
10821568|NCT00069108|FG000|Participant Flow|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
10821569|NCT00069108|FG001|Participant Flow|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
10821570|NCT00069108|OG000|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
10821571|NCT00069108|OG001|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
10821572|NCT00069108|OG001|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
10821573|NCT00069108|EG000|Reported Event|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
10821574|NCT00069108|EG001|Reported Event|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
10810686|NCT03941015|BG000|Baseline|Patients With Renal Desaturation|Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810687|NCT03941015|BG001|Baseline|Patients Without Renal Desaturation|Patients who did't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810688|NCT03941015|BG002|Baseline|Total|Total of all reporting groups
10810689|NCT03941015|FG000|Participant Flow|Renal Desaturation Group|Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810690|NCT03941015|FG001|Participant Flow|Renal Eusaturation Group|Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810691|NCT03941015|OG000|Outcome|Patients With Renal Desaturation|Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810692|NCT03941015|OG001|Outcome|Patients Without Renal Desaturation|Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810693|NCT03941015|EG000|Reported Event|Patients With Renal Desaturation|Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10810694|NCT03941015|EG001|Reported Event|Patients Without Renal Desaturation|Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
10821575|NCT00069121|BG000|Baseline|5-FU/LV|Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
10821576|NCT00069121|BG001|Baseline|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
10821577|NCT00069121|BG002|Baseline|Total|Total of all reporting groups
10821578|NCT00069121|FG000|Participant Flow|5-FU/LV|Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
10821579|NCT00069121|FG001|Participant Flow|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
10821580|NCT00069121|OG000|Outcome|5-FU/LV|Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
10821581|NCT00069121|OG001|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
10821582|NCT00069121|OG000|Outcome|5-FU/LV MAYO CLINIC|Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
10821583|NCT00069121|OG001|Outcome|5-FU/LV ROSWELL PARK|Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
10821584|NCT00069121|OG002|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
10821585|NCT00069121|EG000|Reported Event|5-FU/LV MAYO CLINIC|5-fluorouracil/leucovorin
11244307|NCT02510001|BG007|Baseline|Dose Escalation Phase Dose 5 (Interval Dosing)|"Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11244308|NCT02510001|BG008|Baseline|Total|Total of all reporting groups
10821586|NCT00069121|EG001|Reported Event|5-FU/LV ROSWELL PARK|5-fluorouracil/leucovorin
10821587|NCT00069121|EG002|Reported Event|XELOX|Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
10810695|NCT03889028|BG000|Baseline|Pre-CMV DNAemia|Patients with CMV DNAemia detected prior neutrophil's engraftment
10810696|NCT03889028|BG001|Baseline|Post-CMV DNAemia|Patients with CMV DNAemia detected after neutrophil's engraftment
10810697|NCT03889028|BG002|Baseline|No CMV|Patients without CMV DNAemia
10810698|NCT03889028|BG003|Baseline|Total|Total of all reporting groups
10810699|NCT03889028|FG000|Participant Flow|Pre-CMV DNAemia|Patients who developed CMV DNAemia prior to engraftment
10810700|NCT03889028|FG001|Participant Flow|Post-CMV DNAemia|Patients with CMV DNAemia detected after neutrophil's engraftment
10810701|NCT03889028|FG002|Participant Flow|No CMV DNAemia|Patients without CMV DNAemia throughout the study period
10810702|NCT03889028|OG000|Outcome|Pre-CMV DNAemia|episodes of CMV DNAemia that were detected prior to engraftment
10810703|NCT03889028|OG001|Outcome|Post-CMV DNAemia|episodes of CMV DNAemia that were detected after engraftment
10810704|NCT03889028|EG000|Reported Event|Pre-CMV DNAemia|Patients with CMV DNAemia detected prior neutrophil's engraftment
10810705|NCT03889028|EG001|Reported Event|Post-CMV DNAemia|Patients with CMV DNAemia detected after neutrophil's engraftment
10810706|NCT03889028|EG002|Reported Event|No CMV DNAemia|Patients without CMV DNAemia
10810707|NCT03842683|BG000|Baseline|CGM Users|User of CGM and CSII
10810708|NCT03842683|FG000|Participant Flow|Continuous Glucose Monitoring Users|User of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII)
10810709|NCT03842683|OG000|Outcome|CGM Users|User of CGM and CSII
10810710|NCT03842683|OG000|Outcome|Continuous Glucose Monitoring Users|User of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII)
10810711|NCT03842683|EG000|Reported Event|CGM Users|User of CGM and CSII
10810712|NCT03839511|BG000|Baseline|Intervention|Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
10810713|NCT03839511|FG000|Participant Flow|Intervention|Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
10810714|NCT03839511|OG000|Outcome|Intervention|Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
10810715|NCT03839511|EG000|Reported Event|Intervention|Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
10810716|NCT03835546|BG000|Baseline|Early Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy presenting recent HIV-1 infection. Recent HIV-1 infection was defined as having a positive plasma viral load and/or p24 antigen with a negative ELISA or having a positive ELISA and undetermined Western-Blot, or having a positive ELISA and absence of p31 antigen in a positive Western-Blot, or seroconversion ELISA in less than 3 months.
10810717|NCT03835546|BG001|Baseline|Regularly Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy, did not fulfil the criteria for recent HIV-1 infection, and had an estimated time >6 months reported by the patient and/or by the responsible physician since HIV transmission.
10810718|NCT03835546|BG002|Baseline|Seronegative Volunteers|HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
10810719|NCT03835546|BG003|Baseline|Total|Total of all reporting groups
10810720|NCT03835546|FG000|Participant Flow|Early Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy presenting recent HIV-1 infection. Recent HIV-1 infection was defined as having a positive plasma viral load and/or p24 antigen with a negative ELISA or having a positive ELISA and undetermined Western-Blot, or having a positive ELISA and absence of p31 antigen in a positive Western-Blot, or seroconversion ELISA in less than 3 months.
10810721|NCT03835546|FG001|Participant Flow|Regularly Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy, did not fulfil the criteria for recent HIV-1 infection, and had an estimated time >6 months reported by the patient and/or by the responsible physician since HIV transmission.
10810722|NCT03835546|FG002|Participant Flow|Seronegative Volunteers|HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
10810723|NCT03835546|OG000|Outcome|Early Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy presenting recent HIV-1 infection. Recent HIV-1 infection was defined as having a positive plasma viral load and/or p24 antigen with a negative ELISA or having a positive ELISA and undetermined Western-Blot, or having a positive ELISA and absence of p31 antigen in a positive Western-Blot, or seroconversion ELISA in less than 3 months.
10810724|NCT03835546|OG001|Outcome|Regularly Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy, did not fulfil the criteria for recent HIV-1 infection, and had an estimated time >6 months reported by the patient and/or by the responsible physician since HIV transmission.
10810725|NCT03835546|OG002|Outcome|Seronegative Volunteers|HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
10810726|NCT03835546|EG000|Reported Event|Early Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy presenting recent HIV-1 infection. Recent HIV-1 infection was defined as having a positive plasma viral load and/or p24 antigen with a negative ELISA or having a positive ELISA and undetermined Western-Blot, or having a positive ELISA and absence of p31 antigen in a positive Western-Blot, or seroconversion ELISA in less than 3 months.
10810727|NCT03835546|EG001|Reported Event|Regularly Treated Patients|Patients with confirmed HIV-1 infection attended in the HIV Unit of the Hospital Universitari Germans Trias i Pujol who initiated therapy, did not fulfil the criteria for recent HIV-1 infection, and had an estimated time >6 months reported by the patient and/or by the responsible physician since HIV transmission.
10810728|NCT03835546|EG002|Reported Event|Seronegative Volunteers|HIV-uninfected volunteers, matched to age, sex, and educational level with groups A and B.
10810729|NCT04461795|BG000|Baseline|AJOVY (Fremanezumab-vfrm)|"Participants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.~Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]: 225 MG/1.5 ML Subcutaneous Solution"
10810730|NCT04461795|FG000|Participant Flow|AJOVY (Fremanezumab-vfrm)|"Participants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.~Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]: 225 MG/1.5 ML Subcutaneous Solution"
10810731|NCT04461795|OG000|Outcome|AJOVY (Fremanezumab-vfrm) - Responder|"Participants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.~Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]: 225 MG/1.5 ML Subcutaneous Solution~Participants meeting the 50% response criteria (responders) were identified using participants' self-reported data. Responders for the purpose of this study are defined as any participant with ≥ 50% reduction in the number of migraines from baseline to at least 2 out of the 3 treatment periods."
10810732|NCT04461795|OG001|Outcome|AJOVY (Fremanezumab-vfrm) - Non-Responder|"Participants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.~Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]: 225 MG/1.5 ML Subcutaneous Solution~Participants not meeting the 50% response criteria (non-responders) were identified using participants' self-reported data. Non-responders for the purpose of this study are defined as any participant with < 50% reduction in the number of migraines from baseline to at least 2 out of the 3 treatment periods."
10810733|NCT04461795|EG000|Reported Event|AJOVY (Fremanezumab-vfrm)|"Participants received 225 mg/1.5 mL solution via single-dose prefilled syringe administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for 12 weeks.~Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]: 225 MG/1.5 ML Subcutaneous Solution"
10810734|NCT04405999|BG000|Baseline|Bromhexine Hydrochloride Group|"medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride~Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days"
10810735|NCT04405999|BG001|Baseline|Control Group|medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
10810736|NCT04405999|BG002|Baseline|Total|Total of all reporting groups
11205739|NCT02230904|BG001|Baseline|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
10810737|NCT04405999|FG000|Participant Flow|Treatment Group|"medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride~Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days"
10810738|NCT04405999|FG001|Participant Flow|Control Group|medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
10810739|NCT04405999|OG000|Outcome|Treatment Group|"medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride~Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days"
10810740|NCT04405999|OG001|Outcome|Control Group|medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
10810741|NCT04405999|EG000|Reported Event|Bromhexine Hydrochloride Group|"medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride~Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days"
10810742|NCT04405999|EG001|Reported Event|Control Group|medical personnel at risk for COVID-19 infection without oral administration of Bromhexine hydrochloride
10810743|NCT04383587|BG000|Baseline|Serology Group|Group of participants completing COVID Serologic antibody testing
11244309|NCT02510001|FG000|Participant Flow|Dose Escalation Phase Dose 1.|Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10810744|NCT04383587|FG000|Participant Flow|Serologic Arm|"Enrolled participants will have COVID19 IgG antibody testing performed.~Serologic testing: COVID19 IgG antibody testing performed"
10810745|NCT04383587|OG000|Outcome|Serologic Arm|"Enrolled participants will have COVID19 IgG antibody testing performed.~Serologic testing: COVID19 IgG antibody testing performed"
10810746|NCT04383587|OG000|Outcome|High Confidence of Previous Infection|Participants who indicated in a survey prior to antibody testing that they had a high confidence of previous infection or immunity that would be demonstrated by antibody positivity
10810747|NCT04383587|EG000|Reported Event|Serologic Arm|"Enrolled participants will have COVID19 IgG antibody testing performed.~Serologic testing: COVID19 IgG antibody testing to be performed"
10810748|NCT04035473|BG000|Baseline|Sequence A (Oraxol, IV Paclitaxel)|Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 1 followed by 80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 2
10810749|NCT04035473|BG001|Baseline|Sequence B (IV Paclitaxel, Oraxol)|80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 2
10810750|NCT04035473|BG002|Baseline|Total|Total of all reporting groups
10810751|NCT04035473|FG000|Participant Flow|Sequence A (Oraxol, IV Paclitaxel)|Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 1 followed by 80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 2
10810752|NCT04035473|FG001|Participant Flow|Sequence B (IV Paclitaxel, Oraxol)|80 mg/m2 IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol (15 mg HM30181AK-US tablet + 205 mg/m2 paclitaxel capsules) on Days 1, 2, and 3 of Treatment Period 2
10810753|NCT04035473|OG000|Outcome|Oraxol|615 mg/m2 over 3 Consecutive Days Administered as Oraxol
10810754|NCT04035473|OG001|Outcome|IV Paclitaxel|IV paclitaxel (80 mg/m2) infused over 1 hour
11205740|NCT02230904|BG002|Baseline|Total Title|
11205741|NCT02230904|FG000|Participant Flow|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
11205742|NCT02230904|FG001|Participant Flow|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
10810755|NCT04035473|EG000|Reported Event|Oraxol|Oraxol (15 mg HM30181A + oral paclitaxel 205 mg/m2) for 3 consecutive days.
10810756|NCT04035473|EG001|Reported Event|IV Paclitaxel|IV Pacllitaxel 80 mg/m2 for 1 day.
10821588|NCT00069160|BG000|Baseline|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
10821589|NCT00069160|BG001|Baseline|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
10821590|NCT00069160|BG002|Baseline|Total|Total of all reporting groups
10821591|NCT00069160|FG000|Participant Flow|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
10821592|NCT00069160|FG001|Participant Flow|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
10821593|NCT00069160|OG000|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
10821594|NCT00069160|OG001|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
10821595|NCT00069160|OG000|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
10821596|NCT00069160|OG001|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
10821597|NCT00069160|OG000|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
10821598|NCT00069160|EG000|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
10821599|NCT00069160|EG001|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
10821600|NCT00069264|BG000|Baseline|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
10821601|NCT00069264|FG000|Participant Flow|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
10821602|NCT00069264|OG000|Outcome|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
10821603|NCT00069264|EG000|Reported Event|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
10821604|NCT00069277|BG000|Baseline|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
10821605|NCT00069277|FG000|Participant Flow|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
10821606|NCT00069277|OG000|Outcome|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
10821607|NCT00069277|EG000|Reported Event|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
10821608|NCT00069329|BG000|Baseline|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
10821609|NCT00069329|FG000|Participant Flow|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
10821610|NCT00069329|OG000|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
10821611|NCT00069329|EG000|Reported Event|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
10821612|NCT00069576|BG000|Baseline|Nutritional Counseling & Self Blood Glucose Monitoring|"Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.~nutritional counseling~self blood glucose monitoring"
10821613|NCT00069576|BG001|Baseline|No Treatment|This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
10821614|NCT00069576|BG002|Baseline|Total|Total of all reporting groups
10810757|NCT03796676|BG000|Baseline|Placebo|Participants received two PF-04965842-matching placebo tablets QD
10810758|NCT03796676|BG001|Baseline|PF-04965842 100mg QD|Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
10810759|NCT03796676|BG002|Baseline|PF-04965842 200mg QD|Participants received two PF-04965842 100 mg tablets QD
10810760|NCT03796676|BG003|Baseline|Total|Total of all reporting groups
10810761|NCT03796676|FG000|Participant Flow|Placebo|Participants received two PF-04965842-matching placebo tablets QD
10810762|NCT03796676|FG001|Participant Flow|PF-04965842 100mg QD|Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
10810763|NCT03796676|FG002|Participant Flow|PF-04965842 200mg QD|Participants received two PF-04965842 100 mg tablets QD
10810764|NCT03796676|OG000|Outcome|Placebo|Participants received two PF-04965842-matching placebo tablets QD
10810765|NCT03796676|OG001|Outcome|PF-04965842 100mg QD|Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
10810766|NCT03796676|OG002|Outcome|PF-04965842 200mg QD|Participants received two PF-04965842 100 mg tablets QD
10810767|NCT03796676|OG000|Outcome|Placebo|Participants received PF-04965842-matching placebo tablets QD
10810768|NCT03796676|OG000|Outcome|PF-04965842 100mg QD|Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
10810769|NCT03796676|OG001|Outcome|PF-04965842 200mg QD|Participants received two PF-04965842 100 mg tablets QD
10810770|NCT03796676|EG000|Reported Event|Placebo|Participants received two PF-04965842-matching placebo tablets QD
10810771|NCT03796676|EG001|Reported Event|PF-04965842 100mg QD|Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
10810772|NCT03796676|EG002|Reported Event|PF-04965842 200mg QD|Participants received two PF-04965842 100 mg tablets QD
10810773|NCT03366220|BG000|Baseline|Initial Resuscitation With Plasma|"Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.~Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids."
10810774|NCT03366220|BG001|Baseline|Initial Resuscitation With Balanced Crystalloids|"Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.~Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation."
10810775|NCT03366220|BG002|Baseline|Total|Total of all reporting groups
10810776|NCT03366220|FG000|Participant Flow|Initial Resuscitation With Plasma|"Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.~Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids."
10810777|NCT03366220|FG001|Participant Flow|Initial Resuscitation With Balanced Crystalloids|"Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.~Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation."
10810778|NCT03366220|OG000|Outcome|Initial Resuscitation With Plasma|"Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.~Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids."
10810779|NCT03366220|OG001|Outcome|Initial Resuscitation With Balanced Crystalloids|"Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.~Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation."
10810780|NCT03366220|EG000|Reported Event|Initial Resuscitation With Plasma|"Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.~Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids."
10810781|NCT03366220|EG001|Reported Event|Initial Resuscitation With Balanced Crystalloids|"Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.~Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation."
10810782|NCT02989857|BG000|Baseline|AG-120|Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 24 months.
10810783|NCT02989857|BG001|Baseline|Placebo|Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 24 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
10810784|NCT02989857|BG002|Baseline|Total|Total of all reporting groups
10810785|NCT02989857|FG000|Participant Flow|AG-120|Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 24 months.
10810786|NCT02989857|FG001|Participant Flow|Placebo|Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 24 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
10810787|NCT02989857|FG002|Participant Flow|After Crossover to AG-120|Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 24 months.
10810788|NCT02989857|OG000|Outcome|AG-120|Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 24 months.
10810789|NCT02989857|OG001|Outcome|Placebo|Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 24 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
10810790|NCT02989857|EG000|Reported Event|AG-120|Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 24 months.
10810791|NCT02989857|EG001|Reported Event|Placebo|Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 24 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
10810792|NCT02989857|EG002|Reported Event|After Cross Over to AG-120|Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 24 months.
10810793|NCT02983799|BG000|Baseline|COHORT 1|germline BRCA mutant
10810794|NCT02983799|BG001|Baseline|COHORT 2|somatic BRCA mutant, germline BRCA wild type
10810795|NCT02983799|BG002|Baseline|COHORT 3|HRD positive and no BRCA mutation
10810796|NCT02983799|BG003|Baseline|COHORT 4|HRD negative and no BRCA mutation
10810797|NCT02983799|BG004|Baseline|Unassigned|Cohort unassigned
10810798|NCT02983799|BG005|Baseline|Total|Total of all reporting groups
10810799|NCT02983799|FG000|Participant Flow|COHORT 1|germline BRCA mutant
10810800|NCT02983799|FG001|Participant Flow|COHORT 2|somatic BRCA mutant, germline BRCA wild type
10810801|NCT02983799|FG002|Participant Flow|COHORT 3|HRD positive and no BRCA mutation
10810802|NCT02983799|FG003|Participant Flow|COHORT 4|HRD negative and no BRCA mutation
10810803|NCT02983799|FG004|Participant Flow|Unassigned|Cohort unassigned
11205743|NCT02230904|OG000|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
11205744|NCT02230904|OG001|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
11205745|NCT02230904|OG000|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
11205746|NCT02230904|OG001|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
11205747|NCT02230904|EG000|Reported Event|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
11205748|NCT02230904|EG001|Reported Event|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
10810804|NCT02983799|OG000|Outcome|Cohort 1|germline BRCA mutant
10810805|NCT02983799|OG001|Outcome|Cohort 2|somatic BRCA mutant, germline BRCA wild type
10810806|NCT02983799|OG002|Outcome|COHORT 3|HRD positive and no BRCA mutation
10810807|NCT02983799|OG003|Outcome|COHORT 4|HRD negative and no BRCA mutation
10810808|NCT02983799|OG004|Outcome|Unassigned|Cohort unassigned
10810809|NCT02983799|OG000|Outcome|Cohort 3, HRRm Pos|HRD positive and no BRCA mutation, HRRm positive
10810810|NCT02983799|OG001|Outcome|Cohort 3, HRRm Neg|HRD positive and no BRCA mutation, HRRm negative
10810811|NCT02983799|OG002|Outcome|Cohort 4, HRRm Pos|HRD negative and no BRCA mutation, HRRm positive
11205749|NCT02230956|BG000|Baseline|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
11205750|NCT02230956|BG001|Baseline|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
11205751|NCT02230956|BG002|Baseline|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
11205752|NCT02230956|BG003|Baseline|Total|Total of all reporting groups
11205753|NCT02230956|FG000|Participant Flow|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
11205754|NCT02230956|FG001|Participant Flow|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
11205755|NCT02230956|FG002|Participant Flow|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
11205756|NCT02230956|OG000|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
11205757|NCT02230956|OG001|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
11205758|NCT02230956|OG002|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
10810812|NCT02983799|OG003|Outcome|Cohort 4, HRRm Neg|HRD negative and no BRCA mutation, HRRm negative
10810813|NCT02983799|EG000|Reported Event|COHORT 1|germline BRCA mutant
10810814|NCT02983799|EG001|Reported Event|COHORT 2|somatic BRCA mutant, germline BRCA wild type
10810815|NCT02983799|EG002|Reported Event|COHORT 3|HRD positive and no BRCA mutation
10810816|NCT02983799|EG003|Reported Event|COHORT 4|HRD negative and no BRCA mutation
10810817|NCT02983799|EG004|Reported Event|UNASSIGNED|Cohort unassigned
10810818|NCT02971683|BG000|Baseline|Double-Blind Abatacept|Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)
11205759|NCT02230956|EG000|Reported Event|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
11205760|NCT02230956|EG001|Reported Event|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
11205761|NCT02230956|EG002|Reported Event|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
11205762|NCT02230995|BG000|Baseline|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
11205763|NCT02230995|BG001|Baseline|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
11205764|NCT02230995|BG002|Baseline|Total|Total of all reporting groups
11205765|NCT02230995|FG000|Participant Flow|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
11205766|NCT02230995|FG001|Participant Flow|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
11205767|NCT02230995|OG000|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
11205768|NCT02230995|OG001|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
11205769|NCT02230995|EG000|Reported Event|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
11205770|NCT02230995|EG001|Reported Event|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
11205771|NCT02231086|BG000|Baseline|Standard Adjuvant Systemic Chemotherapy|"Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.~Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms."
11205772|NCT02231086|BG001|Baseline|Adjuvant HIPEC (Open/Laparoscopic)|"Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis flui"
10810819|NCT02971683|BG001|Baseline|Double-Blind Placebo|Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)
10810820|NCT02971683|BG002|Baseline|Total|Total of all reporting groups
10810821|NCT02971683|FG000|Participant Flow|Double-Blind Abatacept|Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)
10810822|NCT02971683|FG001|Participant Flow|Double-Blind Placebo|Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)
11205773|NCT02231086|BG002|Baseline|Total|Total of all reporting groups
11205774|NCT02231086|FG000|Participant Flow|Standard Adjuvant Systemic Chemotherapy|"Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.~Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms."
10810823|NCT02971683|OG000|Outcome|Double-Blind Abatacept|Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)
10810824|NCT02971683|OG001|Outcome|Double-Blind Placebo|Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)
10810825|NCT02971683|EG000|Reported Event|DOUBLE-BLIND ABATACEPT|Subcutaneous abatacept (125 mg weekly) in combination with standard treatment for 24 weeks (6 months)
10810826|NCT02971683|EG001|Reported Event|DOUBLE-BLIND PLACEBO|Placebo to match subcutaneous abatacept in combination with standard treatment for 24 weeks (6 months)
10810827|NCT02682992|BG000|Baseline|Low Level Laser Therapy|"Patients that received prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.~Low Level Laser Therapy: LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J."
10821615|NCT00069576|FG000|Participant Flow|Nutritional Counseling & Self Blood Glucose Monitoring|"Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.~nutritional counseling~self blood glucose monitoring"
10821616|NCT00069576|FG001|Participant Flow|No Treatment|This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
11244310|NCT02510001|FG001|Participant Flow|Dose Escalation Phase Dose 2.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
11244311|NCT02510001|FG002|Participant Flow|Dose Escalation Phase Dose 3.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle
10810828|NCT02682992|FG000|Participant Flow|Low Level Laser Therapy|"Patients that received prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.~Low Level Laser Therapy: LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J."
10810829|NCT02682992|OG000|Outcome|Low Level Laser Therapy|"Patients that received prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.~Low Level Laser Therapy: LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J."
10810830|NCT02682992|EG000|Reported Event|Low Level Laser Therapy|"Patients that received prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.~Low Level Laser Therapy: LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J."
10810831|NCT02631577|BG000|Baseline|Atezolizumab-G-lena 15mg|Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide
10810832|NCT02631577|BG001|Baseline|Atezolizumab-G-lena 20mg|Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
10810833|NCT02631577|BG002|Baseline|Total|Total of all reporting groups
10810834|NCT02631577|FG000|Participant Flow|Atezolizumab-G-lena 15mg|Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide
10810835|NCT02631577|FG001|Participant Flow|Atezolizumab-G-lena 20mg|Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
10810836|NCT02631577|OG000|Outcome|Atezolizumab-G-lena 15mg|Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.
10810837|NCT02631577|OG001|Outcome|Atezolizumab-G-lena 20mg|Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
10810838|NCT02631577|EG000|Reported Event|Atezolizumab-G-lena 15mg|Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide
10810839|NCT02631577|EG001|Reported Event|Atezolizumab-G-lena 20mg|Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
10810840|NCT02573779|BG000|Baseline|Infants Fed Mother's Own Milk|"Infants fed >50% mother's own milk with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810841|NCT02573779|BG001|Baseline|Donor Milk Fed Infants|"Infants fed <50% mother's own milk (and thus >50% donor human milk) with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810842|NCT02573779|BG002|Baseline|Total|Total of all reporting groups
10810843|NCT02573779|FG000|Participant Flow|Infants Fed Mother's Own Milk|"Infants fed >50% mother's own milk with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810844|NCT02573779|FG001|Participant Flow|Donor Milk Fed Infants|"Infants fed <50% mother's own milk (and thus >50% donor human milk) with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810845|NCT02573779|OG000|Outcome|Infants Fed Mother's Own Milk|"Infants fed >50% mother's own milk with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810846|NCT02573779|OG001|Outcome|Donor Milk Fed Infants|"Infants fed <50% mother's own milk (and thus >50% donor human milk) with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810847|NCT02573779|EG000|Reported Event|Infants Fed Mother's Own Milk|"Infants fed >50% mother's own milk with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810848|NCT02573779|EG001|Reported Event|Donor Milk Fed Infants|"Infants fed <50% mother's own milk (and thus >50% donor human milk) with enteral feeding.~Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study."
10810849|NCT02408315|BG000|Baseline|Buccal Misoprostol/Vaginal Placebo|Misoprostol administered buccally with placebo administered vaginally.
10810850|NCT02408315|BG001|Baseline|Vaginal Misoprostol/Buccal Placebo|Misoprostol administered vaginally with placebo administered buccally.
10810851|NCT02408315|BG002|Baseline|Total|Total of all reporting groups
10810852|NCT02408315|FG000|Participant Flow|Buccal Misoprostol/Vaginal Placebo|Misoprostol administered buccally with placebo administered vaginally.
10810853|NCT02408315|FG001|Participant Flow|Vaginal Misoprostol/Buccal Placebo|Misoprostol administered vaginally with placebo administered buccally.
10810854|NCT02408315|OG000|Outcome|Buccal Misoprostol/Vaginal Placebo|Misoprostol administered buccally with placebo administered vaginally.
10810855|NCT02408315|OG001|Outcome|Vaginal Misoprostol/Buccal Placebo|Misoprostol administered vaginally with placebo administered buccally.
10810856|NCT02408315|EG000|Reported Event|Buccal Misoprostol/Vaginal Placebo|Misoprostol administered buccally with placebo administered vaginally.
10810857|NCT02408315|EG001|Reported Event|Vaginal Misoprostol/Buccal Placebo|Misoprostol administered vaginally with placebo administered buccally.
10810858|NCT02300233|BG000|Baseline|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
10810859|NCT02300233|BG001|Baseline|Volanesorsen 300 mg Weekly|Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
10810860|NCT02300233|BG002|Baseline|Volanesorsen 300 mg Biweekly, Post Week 13|Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
10810861|NCT02300233|BG003|Baseline|Total|Total of all reporting groups
10810862|NCT02300233|FG000|Participant Flow|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
10810863|NCT02300233|FG001|Participant Flow|Volanesorsen 300 mg Weekly|Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
10810864|NCT02300233|FG002|Participant Flow|Volanesorsen 300 mg Biweekly, Post Week 13|Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
10810865|NCT02300233|OG000|Outcome|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
10810866|NCT02300233|OG001|Outcome|Volanesorsen Total|Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
10810867|NCT02300233|OG001|Outcome|Volanesorsen 300 mg Weekly|Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
10810868|NCT02300233|OG002|Outcome|Volanesorsen 300 mg Biweekly, Post Week 13|Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
10810869|NCT02300233|EG000|Reported Event|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
10810870|NCT02300233|EG001|Reported Event|Volanesorsen 300 mg Weekly|Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
10810871|NCT02300233|EG002|Reported Event|Volanesorsen 300 mg Biweekly, Post Week 13|Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
10810872|NCT02211209|BG000|Baseline|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
10810873|NCT02211209|BG001|Baseline|Volanesorsen|Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
10810874|NCT02211209|BG002|Baseline|Total|Total of all reporting groups
10810875|NCT02211209|FG000|Participant Flow|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
10810876|NCT02211209|FG001|Participant Flow|Volanesorsen|Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
10810877|NCT02211209|OG000|Outcome|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
10810878|NCT02211209|OG001|Outcome|Volanesorsen|Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
10810879|NCT02211209|EG000|Reported Event|Placebo|Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks.
10810880|NCT02211209|EG001|Reported Event|Volanesorsen|Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
10810881|NCT02125461|BG000|Baseline|Durvalumab (MEDI4736)|Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
10810882|NCT02125461|BG001|Baseline|Placebo|Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
10810883|NCT02125461|BG002|Baseline|Total|Total of all reporting groups
10810884|NCT02125461|FG000|Participant Flow|Durvalumab (MEDI4736)|Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
10810885|NCT02125461|FG001|Participant Flow|Placebo|Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
10810886|NCT02125461|OG000|Outcome|Durvalumab (MEDI4736)|Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
10810887|NCT02125461|OG001|Outcome|Placebo|Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
10810888|NCT02125461|EG000|Reported Event|Durvalumab (MEDI4736)|Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
10810889|NCT02125461|EG001|Reported Event|Placebo|Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
10821617|NCT00069576|OG000|Outcome|Nutritional Counseling & Self Blood Glucose Monitoring|"Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.~nutritional counseling~self blood glucose monitoring"
10821618|NCT00069576|OG001|Outcome|No Treatment|This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
10810890|NCT02000115|BG000|Baseline|Randomized IDE Cohort, Portico Valve|Portico transcatheter aortic valve and Portico delivery system
10810891|NCT02000115|BG001|Baseline|Randomized IDE Cohort, CAV|Any FDA approved, commercially-available transcatheter aortic valve (CAV).
10810892|NCT02000115|BG002|Baseline|FlexNav Delivery System Study|Portico transcatheter aortic valve and FlexNav delivery system
10810893|NCT02000115|BG003|Baseline|Total|Total of all reporting groups
10810894|NCT02000115|FG000|Participant Flow|Randomized IDE Cohort, Portico Valve|Portico transcatheter aortic valve and Portico delivery System.
10810895|NCT02000115|FG001|Participant Flow|Randomized IDE Cohort, CAV|Any FDA approved, commercially-available transcatheter aortic valve (CAV).
10810896|NCT02000115|FG002|Participant Flow|FlexNav Delivery System Study|Portico transcatheter aortic valve and FlexNav delivery system
10810897|NCT02000115|FG003|Participant Flow|Nested Valve-in-Valve Registry|Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve
10810898|NCT02000115|OG000|Outcome|Randomized IDE Cohort, Portico Valve|Portico transcatheter aortic valve and Portico delivery system
10810899|NCT02000115|OG001|Outcome|Randomized IDE Cohort, CAV|Any FDA approved, commercially-available transcatheter aortic valve (CAV).
10810900|NCT02000115|OG000|Outcome|FlexNav Delivery System Study|Portico transcatheter aortic valve and FlexNav delivery system
10810901|NCT02000115|OG001|Outcome|Randomized IDE Cohort, CAV|"Any FDA approved, commercially-available transcatheter aortic valve (CAV).~Status: ACTIVE, NOT ENROLLING.~Commercially available transcatheter aortic valve: Commercially available transcatheter aortic valve"
10810902|NCT02000115|EG000|Reported Event|Randomized IDE Cohort, Portico Valve|Portico transcatheter aortic valve and Portico delivery system
10810903|NCT02000115|EG001|Reported Event|Randomized IDE Cohort, CAV|Any FDA approved, commercially-available transcatheter aortic valve (CAV).
10810904|NCT02000115|EG002|Reported Event|FlexNav Delivery System Study|Portico transcatheter aortic valve and FlexNav delivery system
10810905|NCT01888653|BG000|Baseline|Comparison-Training-Program|"Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes~Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task."
10810906|NCT01888653|BG001|Baseline|Attention Biased Modification|"Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.~Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure."
10810907|NCT01888653|BG002|Baseline|Total|Total of all reporting groups
10810908|NCT01888653|FG000|Participant Flow|Comparison-Training-Program|"Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes~Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task."
10810909|NCT01888653|FG001|Participant Flow|Attention Biased Modification|"Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.~Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure."
10810910|NCT01888653|OG000|Outcome|Comparison-Training-Program|"Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes~Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task."
10821619|NCT00069576|EG000|Reported Event|Nutritional Counseling & Self Blood Glucose Monitoring|"Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.~nutritional counseling~self blood glucose monitoring"
10821620|NCT00069576|EG001|Reported Event|No Treatment|This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
10810911|NCT01888653|OG001|Outcome|Attention Biased Modification|"Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.~Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure."
10810912|NCT01888653|EG000|Reported Event|Comparison-Training-Program|"Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes~Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task."
10810913|NCT01888653|EG001|Reported Event|Attention Biased Modification|"Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.~Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure."
10810914|NCT01813227|BG000|Baseline|Carfilzomib|"Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if > 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.~Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."
10810915|NCT01813227|FG000|Participant Flow|Carfilzomib|"Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if > 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.~Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."
10810916|NCT01813227|OG000|Outcome|Carfilzomib|"Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if > 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.~Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."
11244312|NCT02510001|FG003|Participant Flow|Dose Escalation Phase Dose 4.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10810917|NCT01813227|EG000|Reported Event|Carfilzomib|"Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if > 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.~Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."
10810918|NCT01695317|BG000|Baseline|Acetyl-L-carnitine First, Then Sugar Pills|"Period 1: Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6~Period 2: Glucose with lemon acid Sugar pills Week 1: 500 mg x 3, Week 2-12: 500 mg x 6"
10810919|NCT01695317|BG001|Baseline|Sugar Pills First, Then Acetyl-L-carnitine|"Period 1: Glucose with lemon acid Sugar pills Week 1: 500 mg x 3, Week 2-12: 500 mg x 6~Period 2: Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6"
10810920|NCT01695317|BG002|Baseline|Total|Total of all reporting groups
10810921|NCT01695317|FG000|Participant Flow|Acetyl-L-carnitine First, Then Sugar Pills|Period 1: Acetyl-L-carnitine tablets Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g) Period 2: Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g)
10810922|NCT01695317|FG001|Participant Flow|Sugar Pills First, Then Acetyl-L-carnitine|"Period 1:~Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g) Period 2: Acetyl-L-carnitine: Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g)"
10810923|NCT01695317|OG000|Outcome|Acetyl-L-carnitine|"Acetyl-L-carnitine tablets~Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6"
10810924|NCT01695317|OG001|Outcome|Sugar Pills|"Glucose with lemon acid~Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6"
10810925|NCT01695317|EG000|Reported Event|Acetyl-L-carnitine|"Acetyl-L-carnitine tablets~Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6"
10810926|NCT01695317|EG001|Reported Event|Sugar Pills|"Glucose with lemon acid~Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g):"
10810927|NCT01683825|BG000|Baseline|F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis|"Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810928|NCT01683825|BG001|Baseline|F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis|"Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810929|NCT01683825|BG002|Baseline|F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm|"Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) scans.~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810930|NCT01683825|BG003|Baseline|Total|Total of all reporting groups
10810931|NCT01683825|FG000|Participant Flow|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects|"Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810932|NCT01683825|FG001|Participant Flow|F-18 Florbetapir PET-Healthy Controls|"Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810933|NCT01683825|FG002|Participant Flow|F-18 Florbetapir PET Cardiac Amyloidosis Reproducibility Arm|"Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) scans within 30 days.~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810934|NCT01683825|OG000|Outcome|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects|"Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810935|NCT01683825|OG001|Outcome|F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis|"Control subjects without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810936|NCT01683825|OG002|Outcome|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm|"Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
11244313|NCT02510001|FG004|Participant Flow|Dose Escalation Phase 5.|Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
11244314|NCT02510001|FG005|Participant Flow|Dose Escalation Phase Dose 5a|Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. Crizotinib (PF-02341066) 250mg OD continuous administration
11244315|NCT02510001|FG006|Participant Flow|Dose Escalation Phase Dose 5 (Interval Dosing)|Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
10810937|NCT01683825|OG000|Outcome|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm|"Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810938|NCT01683825|EG000|Reported Event|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects|"Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810939|NCT01683825|EG001|Reported Event|F-18 Florbetapir PET-Healthy Controls|"Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810940|NCT01683825|EG002|Reported Event|F-18 Florbetapir PET-Cardiac Amyloidosis Subjects Reproducibility Arm|"Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) scans within 30 days.~F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)"
10810941|NCT01196936|BG000|Baseline|Arm I (Tamoxifen Citrate)|"Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Tamoxifen Citrate: 5 mg PO Daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810942|NCT01196936|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Placebo: 1 tablet daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810943|NCT01196936|BG002|Baseline|Total|Total of all reporting groups
10810944|NCT01196936|FG000|Participant Flow|Arm I (Tamoxifen Citrate)|"Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Tamoxifen Citrate: 5 mg PO Daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810945|NCT01196936|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Placebo: 1 tablet daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810946|NCT01196936|OG000|Outcome|Arm I (Tamoxifen Citrate)|"Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Tamoxifen Citrate: 5 mg PO Daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810947|NCT01196936|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Placebo: 1 tablet daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810948|NCT01196936|EG000|Reported Event|Arm I (Tamoxifen Citrate)|"Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Tamoxifen Citrate: 5 mg PO Daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810949|NCT01196936|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.~Placebo: 1 tablet daily~Digital mammography: Correlative studies~immunohistochemistry staining method: Correlative Studies~pharmacological study: Correlative Studies~laboratory biomarker analysis: Correlative Studies~protein expression analysis: correlative studies~pharmacogenomic studies: correlative studies~questionnaire administration: Ancillary studies~Fine needle aspiration~Quality of Life Assessment: Ancillary Studies"
10810950|NCT01127451|BG000|Baseline|Denileukin Diftitox on Days 1 to 4|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810951|NCT01127451|BG001|Baseline|Denileukin Diftitox on Days 1, 8, and 15|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810952|NCT01127451|BG002|Baseline|Total|Total of all reporting groups
10810953|NCT01127451|FG000|Participant Flow|Denileukin Diftitox on Days 1 to 4|Participants received Denileukin Diftitox 12 microgram per kilogram per day (mcg/kg/day) on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810954|NCT01127451|FG001|Participant Flow|Denileukin Diftitox on Days 1, 8, and 15|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810955|NCT01127451|OG000|Outcome|Denileukin Diftitox on Days 1 to 4|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810956|NCT01127451|OG001|Outcome|Denileukin Diftitox on Days 1, 8, and 15|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810957|NCT01127451|EG000|Reported Event|Denileukin Diftitox on Days 1 to 4|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810958|NCT01127451|EG001|Reported Event|Denileukin Diftitox on Days 1, 8, and 15|Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
10810959|NCT01004874|BG000|Baseline|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
10810960|NCT01004874|FG000|Participant Flow|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
10810961|NCT01004874|OG000|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
10810962|NCT01004874|EG000|Reported Event|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
10821621|NCT00069641|BG000|Baseline|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
10821622|NCT00069641|BG001|Baseline|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
10821623|NCT00069641|BG002|Baseline|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
10821624|NCT00069641|BG003|Baseline|Total|Total of all reporting groups
10821625|NCT00069641|FG000|Participant Flow|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
10821626|NCT00069641|FG001|Participant Flow|Idursulfase Every Other Week (EOW) (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
10821627|NCT00069641|FG002|Participant Flow|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
11215428|NCT02299167|EG000|Reported Event|Single Group Study / Saddle Block|The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if the patient responded with a failed block then the next patient received an increment of 0.5mg bupivacaine, if the patient responded with a successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.
10821628|NCT00069641|OG000|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
10821629|NCT00069641|OG001|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
10821630|NCT00069641|OG002|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
10821631|NCT00069641|OG001|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
10810963|NCT04762771|BG000|Baseline|Active|"Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.~Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal).~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
10810964|NCT04762771|BG001|Baseline|Control|Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
10810965|NCT04762771|BG002|Baseline|Total|Total of all reporting groups
10810966|NCT04762771|FG000|Participant Flow|Control - Standard of Care Alone|Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
10810967|NCT04762771|FG001|Participant Flow|Active - Colchicine Plus Standard of Care|"Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.~Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal).~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
10810968|NCT04762771|OG000|Outcome|Active|"Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.~Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal).~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
10810969|NCT04762771|OG001|Outcome|Control|Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
10810970|NCT04762771|EG000|Reported Event|Active|"Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.~Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal).~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
10810971|NCT04762771|EG001|Reported Event|Control|Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
10810972|NCT04748120|BG000|Baseline|Operative Management|"Treatment with surgery~Operative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications."
10810973|NCT04748120|BG001|Baseline|Non-operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810974|NCT04748120|BG002|Baseline|Total|Total of all reporting groups
10810975|NCT04748120|FG000|Participant Flow|Operative Management|"Treatment with surgery~Operative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications."
10821632|NCT00069641|EG000|Reported Event|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
10821633|NCT00069641|EG001|Reported Event|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
10821634|NCT00069641|EG002|Reported Event|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
10821635|NCT00069784|BG000|Baseline|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
10821636|NCT00069784|BG001|Baseline|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
10810976|NCT04748120|FG001|Participant Flow|Non-operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810977|NCT04748120|OG000|Outcome|Operative Management|"Treatment with surgery~Operative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications."
10810978|NCT04748120|OG001|Outcome|Non-operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810979|NCT04748120|OG000|Outcome|Non-operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810980|NCT04748120|OG000|Outcome|Non-Operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810981|NCT04748120|EG000|Reported Event|Operative Management|"Treatment with surgery~Operative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications."
10810982|NCT04748120|EG001|Reported Event|Non-operative Management|"Treatment with antibiotics~Non-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:~Non-penicillin allergic patients~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days~Penicillin allergic patients~ertapenem 1g IV every 24 hours for 3 days~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
10810983|NCT04559698|BG000|Baseline|Immediate Training Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the immediate training group will take part in the first 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810984|NCT04559698|BG001|Baseline|Waitlist Control Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the waitlist control group will take part in the second 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810985|NCT04559698|BG002|Baseline|Total|Total of all reporting groups
10821637|NCT00069784|BG002|Baseline|Total|Total of all reporting groups
10810986|NCT04559698|FG000|Participant Flow|Immediate Training Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the immediate training group will take part in the first 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810987|NCT04559698|FG001|Participant Flow|Waitlist Control Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the waitlist control group will take part in the second 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810988|NCT04559698|OG000|Outcome|Immediate Training Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the immediate training group will take part in the first 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810989|NCT04559698|OG001|Outcome|Waitlist Control Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the waitlist control group will take part in the second 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810990|NCT04559698|EG000|Reported Event|Immediate Training Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the immediate training group will take part in the first 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810991|NCT04559698|EG001|Reported Event|Waitlist Control Group|"Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the waitlist control group will take part in the second 11-week course.~LGBTQ-affirmative CBT training: Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week."
10810992|NCT04492475|BG000|Baseline|Remdesivir Plus Interferon Beta-1a|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.
10810993|NCT04492475|BG001|Baseline|Remdesivir Plus Placebo|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.
10810994|NCT04492475|BG002|Baseline|Total|Total of all reporting groups
10810995|NCT04492475|FG000|Participant Flow|Remdesivir Plus Interferon Beta-1a|"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.~Interferon beta-1a: Rebif (R) is a purified 166 amino acid human interferon beta glycoprotein with an amino acid sequence identical to natural fibroblast derived human interferon beta. Each 0.5 mL prefilled syringe contains 44 mcg of interferon beta-1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP.~Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
10810996|NCT04492475|FG001|Participant Flow|Remdesivir Plus Placebo|"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.~Placebo: The interferon beta-1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection.~Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
10810997|NCT04492475|OG000|Outcome|Remdesivir Plus Interferon Beta-1a|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.
10810998|NCT04492475|OG001|Outcome|Remdesivir Plus Placebo|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses.
10810999|NCT04492475|OG000|Outcome|Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.
10811000|NCT04492475|OG001|Outcome|Remdesivir Plus Interferon Beta-1a in Ordinal Score 6|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6
10811001|NCT04492475|OG002|Outcome|Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.
10821638|NCT00069784|FG000|Participant Flow|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
10811002|NCT04492475|OG003|Outcome|Remdesivir Plus Placebo in Baseline Ordinal Score 6|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
10811003|NCT04492475|OG001|Outcome|Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.
10811004|NCT04492475|EG000|Reported Event|Remdesivir Plus Interferon Beta-1a in Ordinal Score 4 and 5|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.
10811005|NCT04492475|EG001|Reported Event|Remdesivir Plus Interferon Beta-1a in Ordinal Score 6|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6
10811006|NCT04492475|EG002|Reported Event|Remdesivir Plus Placebo in Baseline Ordinal Score 4 and 5|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 4 and 5.
11205775|NCT02231086|FG001|Participant Flow|Adjuvant HIPEC (Open/Laparoscopic)|"Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid"
11205776|NCT02231086|OG000|Outcome|Standard Adjuvant Systemic Chemotherapy|"Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.~Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms."
11215429|NCT02299258|BG000|Baseline|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
11215430|NCT02299258|BG001|Baseline|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
10811007|NCT04492475|EG003|Reported Event|Remdesivir Plus Placebo in Baseline Ordinal Score 6|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and a 0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses in participants with a Baseline Ordinal Score of 6.
10811008|NCT04401579|BG000|Baseline|Remdesivir Plus Baricitinib|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
10811009|NCT04401579|BG001|Baseline|Remdesivir Plus Placebo|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
10811010|NCT04401579|BG002|Baseline|Total|Total of all reporting groups
10821639|NCT00069784|FG001|Participant Flow|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
10821640|NCT00069784|OG000|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
10821641|NCT00069784|OG001|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
10821642|NCT00069784|EG000|Reported Event|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
11215431|NCT02299258|BG002|Baseline|Total|Total of all reporting groups
10821643|NCT00069784|EG001|Reported Event|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
10821644|NCT00069823|BG000|Baseline|Placebo|40 mg of placebo twice daily
10821645|NCT00069823|BG001|Baseline|Esomeprazole|40 mg of esomeprazole twice daily
10811011|NCT04401579|FG000|Participant Flow|Remdesivir Plus Baricitinib|"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.~Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.~Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
10811012|NCT04401579|FG001|Participant Flow|Remdesivir Plus Placebo|"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.~Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.~Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet"
10811013|NCT04401579|OG000|Outcome|Remdesivir Plus Baricitinib|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
10811014|NCT04401579|OG001|Outcome|Remdesivir Plus Placebo|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
10811015|NCT04401579|EG000|Reported Event|Remdesivir Plus Baricitinib|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
10811016|NCT04401579|EG001|Reported Event|Remdesivir Plus Placebo|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
11205777|NCT02231086|OG001|Outcome|Adjuvant HIPEC (Open/Laparoscopic)|"Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid"
10811017|NCT04321460|BG000|Baseline|LRG-002|LRG-002 once daily for 14 days
10811018|NCT04321460|BG001|Baseline|Placebo|Placebo once daily for 14 days
10811019|NCT04321460|BG002|Baseline|Total|Total of all reporting groups
10811020|NCT04321460|FG000|Participant Flow|LRG-002|LRG-002 once daily for 14 days
10811021|NCT04321460|FG001|Participant Flow|Placebo|Placebo once daily for 14 days
10811022|NCT04321460|OG000|Outcome|LRG-002|LRG-002 once daily for 14 days
10811023|NCT04321460|OG001|Outcome|Placebo|Placebo once daily for 14 days
10811024|NCT04321460|EG000|Reported Event|LRG-002|LRG-002 once daily for 14 days
10811025|NCT04321460|EG001|Reported Event|Placebo|Placebo once daily for 14 days
10811026|NCT04280705|BG000|Baseline|Placebo|200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
10811027|NCT04280705|BG001|Baseline|Remdesivir|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
10811028|NCT04280705|BG002|Baseline|Total|Total of all reporting groups
10811029|NCT04280705|FG000|Participant Flow|Placebo|"200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.~Placebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies."
10811030|NCT04280705|FG001|Participant Flow|Remdesivir|"200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.~Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
10811031|NCT04280705|OG000|Outcome|Placebo|200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
10811032|NCT04280705|OG001|Outcome|Remdesivir|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
10811033|NCT04280705|EG000|Reported Event|Placebo|200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
10811034|NCT04280705|EG001|Reported Event|Remdesivir|200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
10821646|NCT00069823|BG002|Baseline|Total|Total of all reporting groups
10821647|NCT00069823|FG000|Participant Flow|Placebo|40 mg of placebo twice daily
10821648|NCT00069823|FG001|Participant Flow|Esomeprazole|40 mg of esomeprazole twice daily
10821649|NCT00069823|OG000|Outcome|Placebo|40 mg of placebo twice daily
10821650|NCT00069823|OG001|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
10821651|NCT00069823|EG000|Reported Event|Placebo|40 mg of placebo twice daily
10821652|NCT00069823|EG001|Reported Event|Esomeprazole|40 mg of esomeprazole twice daily
10821653|NCT00069953|BG000|Baseline|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
10821654|NCT00069953|FG000|Participant Flow|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
10821655|NCT00069953|OG000|Outcome|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
10821656|NCT00069953|EG000|Reported Event|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
10821657|NCT00070070|BG000|Baseline|Cohort 1|"HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821658|NCT00070070|BG001|Baseline|Cohort 2|"HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821659|NCT00070070|BG002|Baseline|Cohort 3|"HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821660|NCT00070070|BG003|Baseline|Cohort 4|"HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821661|NCT00070070|BG004|Baseline|Total|Total of all reporting groups
10821662|NCT00070070|FG000|Participant Flow|Cohort 1|"HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
11215432|NCT02299258|FG000|Participant Flow|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
10811035|NCT04208750|BG000|Baseline|R-Refraction Then S-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811036|NCT04208750|BG001|Baseline|S-Refraction Then R-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811037|NCT04208750|BG002|Baseline|Total|Total of all reporting groups
10811038|NCT04208750|FG000|Participant Flow|R-Refraction Then S-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811039|NCT04208750|FG001|Participant Flow|S-Refraction Then R-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811040|NCT04208750|OG000|Outcome|R-Refraction Then S-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811041|NCT04208750|OG001|Outcome|S-Refraction Then R-Refraction|"Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses~Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses"
10811042|NCT04208750|EG000|Reported Event|R-Refraction|Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
10811043|NCT04208750|EG001|Reported Event|S-Refraction|Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
10811044|NCT03713281|BG000|Baseline|Toric Multifocal Etafilcon A With PVP|All subjects dispensed a study lens.
10811045|NCT03713281|FG000|Participant Flow|Toric Multifocal Etafilcon A With PVP|All subjects that were disepnsed the sudy lens.
10811046|NCT03713281|OG000|Outcome|Toric Multifocal Etafilcon A With PVP|All subjects that were dispensed the study lens.
10811047|NCT03713281|EG000|Reported Event|Toric Multifocal Etafilcon A With PVP|All subjects dispensed a stud lens.
10811048|NCT03608254|BG000|Baseline|Watermelon Juice|All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
11215433|NCT02299258|FG001|Participant Flow|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
11244316|NCT02510001|FG007|Participant Flow|Dose Expansion Phase|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10811049|NCT03608254|FG000|Participant Flow|Watermelon Juice|All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
10811050|NCT03608254|OG000|Outcome|Watermelon Juice|Participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
10811051|NCT03608254|EG000|Reported Event|Watermelon Juice|All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
10821663|NCT00070070|FG001|Participant Flow|Cohort 2|"HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821664|NCT00070070|FG002|Participant Flow|Cohort 3|"HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821665|NCT00070070|FG003|Participant Flow|Cohort 4|"HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821666|NCT00070070|OG000|Outcome|Cohort 1|"HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10811052|NCT03512275|BG000|Baseline|Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)|Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811053|NCT03512275|BG001|Baseline|Group B: Bermekimab 400 mg (Anti-TNF Naive)|Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811054|NCT03512275|BG002|Baseline|Total|Total of all reporting groups
10811055|NCT03512275|FG000|Participant Flow|Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)|Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811056|NCT03512275|FG001|Participant Flow|Group B: Bermekimab 400 mg (Anti-TNF Naive)|Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811057|NCT03512275|OG000|Outcome|Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)|Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811058|NCT03512275|OG001|Outcome|Group B: Bermekimab 400 mg (Anti-TNF Naive)|Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811059|NCT03512275|EG000|Reported Event|Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)|Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811060|NCT03512275|EG001|Reported Event|Group B: Bermekimab 400 mg (Anti-TNF Naive)|Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
10811061|NCT03414983|BG000|Baseline|Arm A|Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
10811062|NCT03414983|BG001|Baseline|Arm B|mFOLFOX6/bevacizumab (SOC) every 2 weeks
10811063|NCT03414983|BG002|Baseline|Total|Total of all reporting groups
10811064|NCT03414983|FG000|Participant Flow|Arm A|Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
10811065|NCT03414983|FG001|Participant Flow|Arm B|mFOLFOX6/bevacizumab (SOC) every 2 weeks
10811066|NCT03414983|OG000|Outcome|Arm A|Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
10811067|NCT03414983|OG001|Outcome|Arm B|mFOLFOX6/bevacizumab (SOC) every 2 weeks
11244317|NCT02510001|OG000|Outcome|Dose Escalation Phase Cohort 1 Dose Level 1|Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10811068|NCT03414983|EG000|Reported Event|Arm A|Nivolumab 240 mg + Standard of Care (SOC) mFOLFOX6/bevacizuma every 2 weeks
10811069|NCT03414983|EG001|Reported Event|Arm B|mFOLFOX6/bevacizumab (SOC) every 2 weeks
10811070|NCT03383692|BG000|Baseline|Cohort 1: DS-8201a + Ritonavir|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3.
11244318|NCT02510001|OG001|Outcome|Dose Escalation Phase Cohort 2 Dose Level 2|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10811071|NCT03383692|BG001|Baseline|Cohort 2: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3.
10811072|NCT03383692|BG002|Baseline|Total|Total of all reporting groups
10811073|NCT03383692|FG000|Participant Flow|Cohort 1: DS-8201a + Ritonavir|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
10811074|NCT03383692|FG001|Participant Flow|Cohort 2: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
10811075|NCT03383692|OG000|Outcome|Cohort 1: DS-8201a + Ritonavir|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
10811076|NCT03383692|OG000|Outcome|Cohort 1: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
10811077|NCT03383692|OG000|Outcome|Cohort 2: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
10811078|NCT03383692|OG001|Outcome|Cohort 2: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
10811079|NCT03383692|EG000|Reported Event|Cohort 1: DS-8201a + Ritonavir|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3.
10811080|NCT03383692|EG001|Reported Event|Cohort 2: DS-8201a + Itraconazole|Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3.
11244319|NCT02510001|OG002|Outcome|Dose Escalation Phase Cohort 3 Dose Level 3|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10811081|NCT03371251|BG000|Baseline|Phase 1b: Placebo|Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.
10811082|NCT03371251|BG001|Baseline|Phase 1b: Cohort 1: BOS161721 20 mg|Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811083|NCT03371251|BG002|Baseline|Phase 1b: Cohort 2: BOS161721 60 mg|Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811084|NCT03371251|BG003|Baseline|Phase 1b: Cohort 3: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811085|NCT03371251|BG004|Baseline|Phase 2: Placebo|Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811086|NCT03371251|BG005|Baseline|Phase 2: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811087|NCT03371251|BG006|Baseline|Total|Total of all reporting groups
10811088|NCT03371251|FG000|Participant Flow|Phase 1b: Placebo|Participants were randomized to receive subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.
10811089|NCT03371251|FG001|Participant Flow|Phase 1b: Cohort 1: BOS161721 20 mg|Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811090|NCT03371251|FG002|Participant Flow|Phase 1b: Cohort 2: BOS161721 60 mg|Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811091|NCT03371251|FG003|Participant Flow|Phase 1b: Cohort 3: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811092|NCT03371251|FG004|Participant Flow|Phase 2: Placebo|Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811093|NCT03371251|FG005|Participant Flow|Phase 2: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811094|NCT03371251|OG000|Outcome|Phase 1b: Placebo|Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.
10811095|NCT03371251|OG001|Outcome|Phase 1b: Cohort 1: BOS161721 20 mg|Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811096|NCT03371251|OG002|Outcome|Phase 1b: Cohort 2: BOS161721 60 mg|Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811097|NCT03371251|OG003|Outcome|Phase 1b: Cohort 3: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811098|NCT03371251|OG000|Outcome|Phase 2: Placebo|Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811099|NCT03371251|OG001|Outcome|Phase 2: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811100|NCT03371251|OG000|Outcome|Phase 1b: Cohort 1: BOS161721 20 mg|Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811101|NCT03371251|OG001|Outcome|Phase 1b: Cohort 2: BOS161721 60 mg|Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811102|NCT03371251|OG002|Outcome|Phase 1b: Cohort 3: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811103|NCT03371251|EG000|Reported Event|Phase 1b: Placebo|Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.
10811104|NCT03371251|EG001|Reported Event|Phase 1b: Cohort 1: BOS161721 20 mg|Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811105|NCT03371251|EG002|Reported Event|Phase 1b: Cohort 2: BOS161721 60 mg|Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811106|NCT03371251|EG003|Reported Event|Phase 1b: Cohort 3: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270
10811107|NCT03371251|EG004|Reported Event|Phase 2: Placebo|Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811108|NCT03371251|EG005|Reported Event|Phase 2: BOS161721 120 mg|Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
10811109|NCT03349268|BG000|Baseline|Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units|"Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811110|NCT03349268|BG001|Baseline|Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units|"Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811111|NCT03349268|BG002|Baseline|Patients Cared for on Both PX-UV and Sham Units|Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable.
10811112|NCT03349268|BG003|Baseline|Total|Total of all reporting groups
10811113|NCT03349268|FG000|Participant Flow|Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units|"Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811114|NCT03349268|FG001|Participant Flow|Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units|"Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811115|NCT03349268|FG002|Participant Flow|Patients Cared for on Both PX-UV and Sham Units|"Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable. As a results, they are assigned to this arm to explain their exclusion from each of the single treatment arms. It was not part of the original intention of the study to evaluate patients who were in both study environments.~Because these patients were exposed to both study environments, their outcomes could not be attributed to either study intervention."
10811116|NCT03349268|OG000|Outcome|Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units|"Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811117|NCT03349268|OG001|Outcome|Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units|"Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
11244320|NCT02510001|OG003|Outcome|Dose Escalation Phase Cohort 4 Dose Level 4|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10811118|NCT03349268|EG000|Reported Event|Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units|"Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.~Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2."
10811119|NCT03349268|EG001|Reported Event|Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units|Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
10811120|NCT03349268|EG002|Reported Event|Patients Cared for on Both PX-UV and Sham Units|Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable.
10811121|NCT03307785|BG000|Baseline|Part A: TSR-042 and Niraparib 200 mg QD|Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
10811122|NCT03307785|BG001|Baseline|Part A: TSR-042 and Niraparib 300 mg QD|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
10811123|NCT03307785|BG002|Baseline|Part B: TSR-042 and Carboplatin-paclitaxel|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
10811124|NCT03307785|BG003|Baseline|Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811125|NCT03307785|BG004|Baseline|Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811126|NCT03307785|BG005|Baseline|Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811127|NCT03307785|BG006|Baseline|Part E: TSR-042 and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
10811128|NCT03307785|BG007|Baseline|Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
10811129|NCT03307785|BG008|Baseline|Part G: TSR-042 and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
10811130|NCT03307785|BG009|Baseline|Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
10811131|NCT03307785|BG010|Baseline|Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
10811132|NCT03307785|BG011|Baseline|Total|Total of all reporting groups
10811133|NCT03307785|FG000|Participant Flow|Part A: TSR-042 and Niraparib 200 mg QD|Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
10811134|NCT03307785|FG001|Participant Flow|Part A: TSR-042 and Niraparib 300 mg QD|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
10811135|NCT03307785|FG002|Participant Flow|Part B: TSR-042 and Carboplatin-paclitaxel|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
10811136|NCT03307785|FG003|Participant Flow|Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811137|NCT03307785|FG004|Participant Flow|Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811138|NCT03307785|FG005|Participant Flow|Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811139|NCT03307785|FG006|Participant Flow|Part E: TSR-042 and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
10811140|NCT03307785|FG007|Participant Flow|Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
10811141|NCT03307785|FG008|Participant Flow|Part G: TSR-042 and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
10811142|NCT03307785|FG009|Participant Flow|Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
10811143|NCT03307785|FG010|Participant Flow|Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
10811144|NCT03307785|OG000|Outcome|Part A: TSR-042 and Niraparib 200 mg QD|Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
10811145|NCT03307785|OG001|Outcome|Part A: TSR-042 and Niraparib 300 mg QD|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
10811146|NCT03307785|OG000|Outcome|Part B: TSR-042 and Carboplatin-paclitaxel|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
10811147|NCT03307785|OG000|Outcome|Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811148|NCT03307785|OG001|Outcome|Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811149|NCT03307785|OG000|Outcome|Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811150|NCT03307785|OG000|Outcome|Part E: TSR-042 and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
10811151|NCT03307785|OG000|Outcome|Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
10811152|NCT03307785|OG000|Outcome|Part G: TSR-042 and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
10811153|NCT03307785|OG000|Outcome|Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
10811154|NCT03307785|OG000|Outcome|Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel|Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
10811155|NCT03307785|EG000|Reported Event|Part A: TSR-042 and Niraparib 200 mg QD|Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
10811156|NCT03307785|EG001|Reported Event|Part A: TSR-042 and Niraparib 300 mg QD|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
10811157|NCT03307785|EG002|Reported Event|Part B: TSR-042 and Carboplatin-paclitaxel|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
10811158|NCT03307785|EG003|Reported Event|Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811159|NCT03307785|EG004|Reported Event|Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811160|NCT03307785|EG005|Reported Event|Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
10811161|NCT03307785|EG006|Reported Event|Part E: TSR-042 and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
10811162|NCT03307785|EG007|Reported Event|Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed|Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
10811163|NCT03088826|BG000|Baseline|MSIR and Acetaminophen Group|"The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen~Morphine Sulfate: 15mg PO morphine sulfate~Acetaminophen: 650 mg Acetaminophen"
10811164|NCT03088826|BG001|Baseline|Oxycodone and Acetaminophen Group|"The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen~Oxycodone: 10mg Oxycodone~Acetaminophen: 650 mg Acetaminophen"
10811165|NCT03088826|BG002|Baseline|Total|Total of all reporting groups
10811166|NCT03088826|FG000|Participant Flow|MSIR and Acetaminophen Group|"The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen~Morphine Sulfate: 15mg PO morphine sulfate~Acetaminophen: 650 mg Acetaminophen"
10811167|NCT03088826|FG001|Participant Flow|Oxycodone and Acetaminophen Group|"The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen~Oxycodone: 10mg Oxycodone~Acetaminophen: 650 mg Acetaminophen"
10811168|NCT03088826|OG000|Outcome|MSIR and Acetaminophen Group|"The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen~Morphine Sulfate: 15mg PO morphine sulfate~Acetaminophen: 650 mg Acetaminophen"
10811169|NCT03088826|OG001|Outcome|Oxycodone and Acetaminophen Group|"The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen~Oxycodone: 10mg Oxycodone~Acetaminophen: 650 mg Acetaminophen"
10811170|NCT03088826|EG000|Reported Event|MSIR and Acetaminophen Group|"The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen~Morphine Sulfate: 15mg PO morphine sulfate~Acetaminophen: 650 mg Acetaminophen"
11215434|NCT02299258|OG000|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
10811171|NCT03088826|EG001|Reported Event|Oxycodone and Acetaminophen Group|"The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen~Oxycodone: 10mg Oxycodone~Acetaminophen: 650 mg Acetaminophen"
10811172|NCT03043872|BG000|Baseline|All Patients: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811173|NCT03043872|BG001|Baseline|All Patients: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811174|NCT03043872|BG002|Baseline|All Patients: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811175|NCT03043872|BG003|Baseline|Total|Total of all reporting groups
10811176|NCT03043872|FG000|Participant Flow|All Patients: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 milligrams (mg) in combination with tremelimumab (T) 75 mg intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/meters squared [m^2]) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811177|NCT03043872|FG001|Participant Flow|All Patients: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811178|NCT03043872|FG002|Participant Flow|All Patients: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811179|NCT03043872|OG000|Outcome|Global Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
11215435|NCT02299258|OG001|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
11215436|NCT02299258|EG000|Reported Event|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
10811180|NCT03043872|OG001|Outcome|Global Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811181|NCT03043872|OG000|Outcome|Global Cohort: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811182|NCT03043872|OG001|Outcome|Global Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811183|NCT03043872|OG002|Outcome|Global Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811184|NCT03043872|OG000|Outcome|China Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811185|NCT03043872|OG001|Outcome|China Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811186|NCT03043872|OG000|Outcome|China Cohort: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811187|NCT03043872|OG001|Outcome|China Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811188|NCT03043872|OG002|Outcome|China Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811189|NCT03043872|EG000|Reported Event|Global Cohort: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811190|NCT03043872|EG001|Reported Event|Global Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811191|NCT03043872|EG002|Reported Event|Global Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811192|NCT03043872|EG003|Reported Event|China Cohort: D + T + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy."
10811193|NCT03043872|EG004|Reported Event|China Cohort: D + EP|"During Chemotherapy:~Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).~Post-Chemotherapy:~Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met."
10811194|NCT03043872|EG005|Reported Event|China Cohort: EP|For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
10811195|NCT03034018|BG000|Baseline|Suvorexant|suvorexant 10-20 mg taken at bedtime for four weeks
10811196|NCT03034018|BG001|Baseline|Placebo|placebo taken at bedtime for four weeks
10811197|NCT03034018|BG002|Baseline|Total|Total of all reporting groups
11244321|NCT02510001|OG000|Outcome|Dose Expansion Phase|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10811198|NCT03034018|FG000|Participant Flow|Suvorexant|suvorexant 10-20 mg taken at bedtime for four weeks
10811199|NCT03034018|FG001|Participant Flow|Placebo|placebo taken at bedtime for four weeks
11205778|NCT02231086|EG000|Reported Event|Standard Adjuvant Systemic Chemotherapy|"Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Standard adjuvant systemic chemotherapy: Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.~Diagnostic laparoscopy: Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms."
11205779|NCT02231086|EG001|Reported Event|Adjuvant HIPEC (Open/Laparoscopic)|"Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.~Adjuvant HIPEC (open/laparoscopic): Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis flui"
11205780|NCT02231164|BG000|Baseline|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205781|NCT02231164|BG001|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205782|NCT02231164|BG002|Baseline|Total|Total of all reporting groups
11205783|NCT02231164|FG000|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205784|NCT02231164|FG001|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205785|NCT02231164|OG000|Outcome|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205786|NCT02231164|OG001|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205787|NCT02231164|EG000|Reported Event|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205788|NCT02231164|EG001|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
11205789|NCT02231177|BG000|Baseline|All Subjects|"A randomised, active-controlled, double-blind, 3-way crossover study in patients with COPD (chronic obstructive pulmonary disease). All participants received each of the three treatment arms in a randomly assigned order, the three treatments, which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg.~Tiotropium 5 µg."
10811200|NCT03034018|OG000|Outcome|Suvorexant|suvorexant 10-20 mg taken at bedtime for four weeks
10811201|NCT03034018|OG001|Outcome|Placebo|placebo taken at bedtime for four weeks
10811202|NCT03034018|EG000|Reported Event|Suvorexant|suvorexant 10-20 mg taken at bedtime for four weeks
10811203|NCT03034018|EG001|Reported Event|Placebo|placebo taken at bedtime for four weeks
10811204|NCT02750215|BG000|Baseline|Capmatinib (INC280)|"Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib.~After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles~Capmatinib (INC280): treatment with Capmatinib (INC280)"
10811205|NCT02750215|FG000|Participant Flow|Capmatinib (INC280)|"Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib.~After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles~Capmatinib (INC280): treatment with Capmatinib (INC280)"
10811206|NCT02750215|OG000|Outcome|Capmatinib (INC280)|"Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib.~After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles~Capmatinib (INC280): treatment with Capmatinib (INC280)"
10811207|NCT02750215|EG000|Reported Event|Capmatinib (INC280)|"Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib.~After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles~Capmatinib (INC280): treatment with Capmatinib (INC280)"
10811208|NCT02673333|BG000|Baseline|Pembrolizumab|"Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.~Pembrolizumab"
10811209|NCT02673333|FG000|Participant Flow|Pembrolizumab|"Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.~Pembrolizumab"
10811210|NCT02673333|OG000|Outcome|Pembrolizumab|"Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.~Pembrolizumab"
10811211|NCT02673333|EG000|Reported Event|Pembrolizumab|"Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.~Pembrolizumab"
10811212|NCT01984346|BG000|Baseline|Convergent Procedure|"Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment~AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811213|NCT01984346|BG001|Baseline|Standalone Endocardial Catheter Ablation|"Procedure/Surgery: Endocardial Catheter Ablation Treatment~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811214|NCT01984346|BG002|Baseline|Total|Total of all reporting groups
10811215|NCT01984346|FG000|Participant Flow|Convergent Procedure|"Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment~AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811216|NCT01984346|FG001|Participant Flow|Standalone Endocardial Catheter Ablation|"Procedure/Surgery: Endocardial Catheter Ablation Treatment~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811217|NCT01984346|OG000|Outcome|Convergent Procedure|"Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment~AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811218|NCT01984346|OG001|Outcome|Standalone Endocardial Catheter Ablation|"Procedure/Surgery: Endocardial Catheter Ablation Treatment~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811219|NCT01984346|EG000|Reported Event|Convergent Procedure|"Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment~AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811220|NCT01984346|EG001|Reported Event|Standalone Endocardial Catheter Ablation|"Procedure/Surgery: Endocardial Catheter Ablation Treatment~Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure"
10811221|NCT01750281|BG000|Baseline|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
10811222|NCT01750281|BG001|Baseline|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811223|NCT01750281|BG002|Baseline|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811224|NCT01750281|BG003|Baseline|Total|Total of all reporting groups
10811225|NCT01750281|FG000|Participant Flow|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
10811226|NCT01750281|FG001|Participant Flow|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811227|NCT01750281|FG002|Participant Flow|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811228|NCT01750281|OG000|Outcome|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
10811229|NCT01750281|OG001|Outcome|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811230|NCT01750281|OG002|Outcome|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811231|NCT01750281|EG000|Reported Event|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
10811232|NCT01750281|EG001|Reported Event|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811233|NCT01750281|EG002|Reported Event|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
10811234|NCT01353118|BG000|Baseline|Gastric Bypass|Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
10811235|NCT01353118|BG001|Baseline|Gastric Bypass 2|"Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia~gastric bypass: Optimise glucose control within 3 months before operation"
10811236|NCT01353118|BG002|Baseline|Total|Total of all reporting groups
10811237|NCT01353118|FG000|Participant Flow|Gastric Bypass|Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
10811238|NCT01353118|FG001|Participant Flow|Gastric Bypass 2|"Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia~gastric bypass: Optimise glucose control within 3 months before operation"
10811239|NCT01353118|OG000|Outcome|Gastric Bypass|Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
10811240|NCT01353118|OG001|Outcome|Gastric Bypass 2|"Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia~gastric bypass: Optimise glucose control within 3 months before operation"
10811241|NCT01353118|EG000|Reported Event|Gastric Bypass|Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
10811242|NCT01353118|EG001|Reported Event|Gastric Bypass 2|"Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia~gastric bypass: Optimise glucose control within 3 months before operation"
10811243|NCT01252953|BG000|Baseline|Anacetrapib|Anacetrapib: 100mg tablet daily
10811244|NCT01252953|BG001|Baseline|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
10811245|NCT01252953|BG002|Baseline|Total|Total of all reporting groups
10811246|NCT01252953|FG000|Participant Flow|Anacetrapib|Anacetrapib: 100mg tablet daily
10811247|NCT01252953|FG001|Participant Flow|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
10811248|NCT01252953|OG000|Outcome|Anacetrapib|Anacetrapib: 100mg tablet daily
10811249|NCT01252953|OG001|Outcome|Placebo Anacetrapib|Placebo anacetrapib: 1 tablet daily
10811250|NCT01252953|OG000|Outcome|Anacetrapib|Anacetrapib: 100mg daily
10811251|NCT01252953|EG000|Reported Event|Anacetrapib|anacetrapib: tablet, 100mg daily
10811252|NCT01252953|EG001|Reported Event|Placebo Anacetrapib|placebo anacetrapib: tablet, 1 tablet daily
10811253|NCT01012609|BG000|Baseline|Pts With High-grade Astrocytoma|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811254|NCT01012609|BG001|Baseline|Pts With Diffuse Pontine Tumor|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811255|NCT01012609|BG002|Baseline|Total|Total of all reporting groups
10821667|NCT00070070|OG001|Outcome|Cohort 2|"HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10811256|NCT01012609|FG000|Participant Flow|Pts With High-grade Astrocytoma|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811257|NCT01012609|FG001|Participant Flow|Pts With Diffuse Pontine Tumor|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811258|NCT01012609|OG000|Outcome|Pts With High-grade Astrocytoma|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811259|NCT01012609|OG001|Outcome|Pts With Diffuse Pontine Tumor|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811260|NCT01012609|OG000|Outcome|HGA and DIPG Tumors Analyzed|Paraffin-embedded tumor sections were obtained from 19 of 23 patients who underwent surgery (18 HGA and one DIPG tumors). Found tumor markers are reported as one group in the publication.
10811261|NCT01012609|EG000|Reported Event|Pts With High-grade Astrocytoma|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811262|NCT01012609|EG001|Reported Event|Pts With Diffuse Pontine Tumor|"This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.~cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week."
10811263|NCT00920387|BG000|Baseline|Full Dose LSD (200 mcg)|"200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811264|NCT00920387|BG001|Baseline|Active Placebo LSD (20 mcg)|"20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811265|NCT00920387|BG002|Baseline|Total|Total of all reporting groups
10811266|NCT00920387|FG000|Participant Flow|Full Dose LSD (200 mcg) Blinded Stage 1|"200 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1~200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811267|NCT00920387|FG001|Participant Flow|Active Placebo LSD (20 mcg) Stage 1|"20 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1.~20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811268|NCT00920387|FG002|Participant Flow|Full Dose LSD (200 mcg) Open-Label Stage 2|200 mcg LSD administered open-label once during two experimental sessions, scheduled two to eight weeks apart during Stage 2
10811269|NCT00920387|OG000|Outcome|Full Dose LSD (200 mcg)|"200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811270|NCT00920387|OG001|Outcome|Active Placebo LSD (20 mcg)|"20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811271|NCT00920387|EG000|Reported Event|Full Dose LSD (200 mcg Stage 1)|"200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811272|NCT00920387|EG001|Reported Event|Active Placebo LSD (20 mcg Stage 1)|"20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.~20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
10811273|NCT00920387|EG002|Reported Event|Full Dose LSD (200 mcg Stage 2)|"200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to eight weeks apart.~200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session~Therapy: Therapy provided by male and female co-therapists"
11205790|NCT02231177|FG000|Participant Flow|Tio+Olo 5/10 μg, Olo 10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol (Olo) 10 µg.~Tiotropium (Tio) 5 µg."
11205791|NCT02231177|FG001|Participant Flow|Tio+Olo 5/10 μg, Tio 5 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg.~Olodaterol 10 µg."
10811287|NCT00458835|BG000|Baseline|Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI|Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
10811288|NCT00458835|BG001|Baseline|Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray|Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray.
10811289|NCT00458835|BG002|Baseline|Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol|Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
10811290|NCT00458835|BG003|Baseline|Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol|Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
10811291|NCT00458835|BG004|Baseline|Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI|Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
10811292|NCT00458835|BG005|Baseline|Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray|Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, Ciclesonide 300 mcg intranasally via aqueous nasal spray.
10811293|NCT00458835|BG006|Baseline|Total|Total of all reporting groups
10811294|NCT00458835|FG000|Participant Flow|Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI|Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
10811295|NCT00458835|FG001|Participant Flow|Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray|Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray.
10811296|NCT00458835|FG002|Participant Flow|Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol|Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
10811297|NCT00458835|FG003|Participant Flow|Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol|Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
10811298|NCT00458835|FG004|Participant Flow|Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI|Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
10811299|NCT00458835|FG005|Participant Flow|Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray|Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, Ciclesonide 300 mcg intranasally via aqueous nasal spray.
10811300|NCT00458835|OG000|Outcome|Ciclesonide Nasal Spray|Ciclesonide 300 mcg intranasally via aqueous nasal spray
10811301|NCT00458835|OG001|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide 300 mcg intranasally via HFA nasal aerosol
10811302|NCT00458835|OG002|Outcome|Ciclesonide HFA MDI|Ciclesonide 320 mcg orally inhaled via HFA MDI
10811303|NCT00458835|EG000|Reported Event|Ciclesonide Nasal Spray|Ciclesonide 300 mcg intranasally via aqueous nasal spray
10811304|NCT00458835|EG001|Reported Event|Ciclesonide Nasal Aerosol|Ciclesonide 300 mcg intranasally via HFA nasal aerosol
10811305|NCT00458835|EG002|Reported Event|Ciclesonide HFA MDI|Ciclesonide 320 mcg orally inhaled via HFA MDI
10811306|NCT00403559|BG000|Baseline|Elidel Cream 1%|In a randomized fashion, fifty six participants with facial seborrheic dermatitis were assigned to Elidel Cream 1% (pimecrolimus) to be applied twice daily for 4 weeks
10811307|NCT00403559|BG001|Baseline|Ketoconazole Cream 2%|n a randomized fashion, fifty six participants with facial seborrheic dermatitis were assigned to Ketoconazole Cream 2% to be applied twice daily for 4 weeks
10811308|NCT00403559|BG002|Baseline|Total|Total of all reporting groups
10811309|NCT00403559|FG000|Participant Flow|Elidel Cream|Participants randomly assigned Elidel Cream twice daily for four weeks.
10811310|NCT00403559|FG001|Participant Flow|Ketoconazole Cream|Participants randomly selected to apply Ketoconazole Cream twice daily for 4 weeks.
10811311|NCT00403559|OG000|Outcome|Elidel (Pimecrolimus) Cream 1% Arm|The Change in F-IGA from BL to Wk 1 assigned Elidel Cream (pimecrolimus) 1%
10811312|NCT00403559|OG001|Outcome|Ketoconazole Cream 2% Arm|The Change in F-IGA from BL to Wk 1 assigned Ketoconazole Cream 2%
10811313|NCT00403559|OG000|Outcome|Elidel Cream (Pimecrolimus)|"Elidel Cream to be applied twice daily for 4 weeks~Elidel"
10811314|NCT00403559|OG001|Outcome|Ketoconazole Cream (Nizoral)|"Ketoconazole Cream to be applied twice daily for 4 weeks~Ketoconazole Cream"
11205792|NCT02231177|FG002|Participant Flow|Olo 10 μg, Tio+Olo 5/10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg."
10811315|NCT00403559|EG000|Reported Event|Elidel Cream|Elidel (pimecrolimus) Cream 1% Arm
10811316|NCT00403559|EG001|Reported Event|Ketoconazole Cream|Ketoconazole Cream 2% Arm
10811317|NCT00353938|BG000|Baseline|Full Dose MDMA-assisted Therapy (125 mg)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811318|NCT00353938|BG001|Baseline|Active Placebo MDMA-assisted Therapy (25 mg)|"Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA~3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811319|NCT00353938|BG002|Baseline|Total|Total of all reporting groups
10811320|NCT00353938|FG000|Participant Flow|Full Dose MDMA-assisted Therapy (125 mg Stage 1)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811321|NCT00353938|FG001|Participant Flow|Active Placebo MDMA-assisted Therapy (25 mg Stage 1)|"Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA~3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811322|NCT00353938|FG002|Participant Flow|Full Dose MDMA-assisted Therapy (125 mg Stage 2)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally."
10811323|NCT00353938|FG003|Participant Flow|Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)|"Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later.~3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally."
10811324|NCT00353938|OG000|Outcome|Full Dose MDMA-assisted Therapy (125 mg)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811325|NCT00353938|OG001|Outcome|Active Placebo MDMA-assisted Therapy (25 mg)|"Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA~3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811326|NCT00353938|EG000|Reported Event|Full Dose MDMA-assisted Therapy (125 mg Stage 1)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811327|NCT00353938|EG001|Reported Event|Active Placebo MDMA-assisted Therapy (25 mg Stage 1)|"Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA~3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.~Therapy: Non-directive therapy performed by a team of two co-therapists"
10811328|NCT00353938|EG002|Reported Event|Full Dose MDMA-assisted Therapy (125 mg Stage 2)|"Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA~3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally."
10811329|NCT00353938|EG003|Reported Event|Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)|"Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later.~3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally."
10811330|NCT00176436|BG000|Baseline|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
10811331|NCT00176436|BG001|Baseline|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
10811332|NCT00176436|BG002|Baseline|Total|Total of all reporting groups
10811333|NCT00176436|FG000|Participant Flow|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
10811334|NCT00176436|FG001|Participant Flow|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
10811335|NCT00176436|OG000|Outcome|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
10811336|NCT00176436|OG001|Outcome|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
10811337|NCT00176436|EG000|Reported Event|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
10811338|NCT00176436|EG001|Reported Event|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
10821668|NCT00070070|OG002|Outcome|Cohort 3|"HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821669|NCT00070070|OG003|Outcome|Cohort 4|"HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10847613|NCT00284089|EG002|Reported Event|Extension Group A+B: Ranibizumab 0.3 mg|In the extension phase, enrolled patients received an intravitreal injection of 0.3 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
10811339|NCT04749459|BG000|Baseline|All Study Participants|Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
10811340|NCT04749459|FG000|Participant Flow|All Study Participants|Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
10811341|NCT04749459|OG000|Outcome|CSM Classic|All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.
10811342|NCT04749459|OG001|Outcome|P2 Control Standard (vs. CSM Classic)|All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.
10811343|NCT04749459|OG002|Outcome|CSM Strawberry Flavor|All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.
10811344|NCT04749459|OG003|Outcome|P2 Control Standard (vs. CSM Strawberry Flavor)|All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.
10811345|NCT04749459|EG000|Reported Event|CSM Classic|All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.
10811346|NCT04749459|EG001|Reported Event|P2 Control Standard (vs. CSM Classic)|All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.
10811347|NCT04749459|EG002|Reported Event|CSM Strawberry Flavor|All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.
10811348|NCT04749459|EG003|Reported Event|P2 Control Standard (vs. CSM Strawberry Flavor)|All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.
10811349|NCT04749459|EG004|Reported Event|All Study Participants|Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
10811350|NCT04702984|BG000|Baseline|LID021201|LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
10811351|NCT04702984|FG000|Participant Flow|LID021201|LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
10811352|NCT04702984|OG000|Outcome|LID021201|LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
10811353|NCT04702984|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
10811354|NCT04702984|EG001|Reported Event|LID021201 Ocular|Events reported in this group occurred while exposed to the study contact lenses
10811355|NCT04702984|EG002|Reported Event|LID021201 Nonocular|Events reported in this group occurred while exposed to the study contact lenses
10811356|NCT04633564|BG000|Baseline|MYL-1402O|"Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ).~In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.~Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811357|NCT04633564|BG001|Baseline|Avastin|"Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin).~In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.~Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
11244322|NCT02510001|OG000|Outcome|Dose Escalation Phase Cohort 7 Dose Level 5|"Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11244323|NCT02510001|OG001|Outcome|Dose Escalation Phase Cohort 12 Dose Level 5 (Interval Dosing)|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10811358|NCT04633564|BG002|Baseline|Total|Total of all reporting groups
11244324|NCT02510001|OG002|Outcome|Dose Escalation Phase Cohort 13 Dose Level 5a|"Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10811359|NCT04633564|FG000|Participant Flow|MYL-1402O|"Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ).~In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.~Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811360|NCT04633564|FG001|Participant Flow|Avastin|"Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin).~In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.~Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811361|NCT04633564|OG000|Outcome|MYL-1402O|"Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ).~In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.~Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811362|NCT04633564|OG001|Outcome|Avastin|"Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin).~In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.~Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811363|NCT04633564|EG000|Reported Event|MYL-1402O|"Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ).~In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.~Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811364|NCT04633564|EG001|Reported Event|Avastin|"Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin).~In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.~Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV"
10811365|NCT04481035|BG000|Baseline|N-Acetylcysteine Followed by Placebo|Participants will be dosed with 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine (NAC) for eight (8) weeks, followed by placebo three times per day for 8 weeks.
10811366|NCT04481035|BG001|Baseline|Placebo Followed by N-Acetylcysteine|Participants will be dosed three times per day with a placebo for eight (8) weeks followed by 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine for 8 weeks.
10811367|NCT04481035|BG002|Baseline|Total|Total of all reporting groups
10811368|NCT04481035|FG000|Participant Flow|N-Acetylcysteine Followed by Placebo|Participants will be dosed with 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine (NAC) for eight (8) weeks, followed by placebo three times per day for 8 weeks.
10811369|NCT04481035|FG001|Participant Flow|Placebo Followed by N-Acetylcysteine|Participants will be dosed three times per day with a placebo for eight (8) weeks followed by 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine for 8 weeks.
10811370|NCT04481035|OG000|Outcome|N-Acetylcysteine|"Participants will be dosed with 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine (NAC) for eight (8) weeks. This is a double-blind study, neither study participant nor study team members will know whether the participant is given study drug or placebo until after all data is collected.~N-acetylcysteine (NAC): The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the experimental phase/arm will receive 70 mg/kg/dose (max dose 900 mg) three times per day of NAC for eight (8) weeks."
10811371|NCT04481035|OG001|Outcome|Placebo|"Participants will be dosed three times per day with a placebo for eight (8) weeks. This is a double-blind study, neither study participant nor study team members will know whether the participant is given study drug or placebo until after all data is collected.~Placebo: The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the placebo phase/arm will receive placebo (non-drug) three times per day for eight (8) weeks."
10811372|NCT04481035|EG000|Reported Event|N-Acetylcysteine Treatment|Participants will be dosed with 70 mg/kg/dose (max dose 900 mg) three times per day of N-Acetylcysteine (NAC) for eight (8) weeks.
10811373|NCT04481035|EG001|Reported Event|Placebo|Participants will be dosed three times per day with a placebo for eight (8) weeks.
10811374|NCT04195958|BG000|Baseline|Omalizumab|Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
10811375|NCT04195958|FG000|Participant Flow|Omalizumab|Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
10811376|NCT04195958|OG000|Outcome|Omalizumab|Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
10811377|NCT04195958|EG000|Reported Event|Omalizumab|Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
10811378|NCT04191148|BG000|Baseline|LBP-EC01|"crPhage cocktail~LBP-EC01: crPhage cocktail"
10811379|NCT04191148|BG001|Baseline|Placebo|"Lactated Ringer's solution, injection, USP~Lactated Ringers Solution for Injection: Placebo"
10811380|NCT04191148|BG002|Baseline|Total|Total of all reporting groups
11205793|NCT02231177|FG003|Participant Flow|Olo 10 μg, Tio 5 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
11205794|NCT02231177|FG004|Participant Flow|Tio 5 μg, Tio+Olo 5/10 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg."
10811381|NCT04191148|FG000|Participant Flow|LBP-EC01|crPhage cocktail: at approximately 1.5 x 10^10 to 3.0 x 10^10 PFU/vial dosed BID by intraurethral administration
10811382|NCT04191148|FG001|Participant Flow|Placebo|Lactated Ringer's solution injection dosed BID by intraurethral administration
10811383|NCT04191148|OG000|Outcome|LBP-EC01|"crPhage cocktail~LBP-EC01: crPhage cocktail"
11205795|NCT02231177|FG005|Participant Flow|Tio 5 μg, Olo 10 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
11205796|NCT02231177|OG000|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
11205797|NCT02231177|OG001|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
11205798|NCT02231177|OG001|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
11205799|NCT02231177|OG002|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
11205800|NCT02231177|EG000|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
10811384|NCT04191148|OG001|Outcome|Placebo|"Lactated Ringer's solution, injection, USP~Lactated Ringers Solution for Injection: Placebo"
10811385|NCT04191148|OG000|Outcome|LBP-EC01|crPhage cocktail: at approximately 1.5 x 10^10 to 3.0 x 10^10 PFU/vial dosed BID by intraurethral administration
10811386|NCT04191148|OG001|Outcome|Placebo|Lactated Ringers Solution for Injection dosed BID by intraurethral administration
10811387|NCT04191148|EG000|Reported Event|LBP-EC01|"crPhage cocktail~LBP-EC01: crPhage cocktail"
10811388|NCT04191148|EG001|Reported Event|Placebo|"Lactated Ringer's solution, injection, USP~Lactated Ringers Solution for Injection: Placebo"
10811389|NCT04130802|BG000|Baseline|OCS-01 1.5% mg/mL QD|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops~Placebo: Vehicle eye drops"
10811390|NCT04130802|BG001|Baseline|OCS-01 1.5% mg/mL BID|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811391|NCT04130802|BG002|Baseline|Placebo (Vehicle) BID|"eye drops~Placebo: Vehicle eye drops"
10811392|NCT04130802|BG003|Baseline|Total|Total of all reporting groups
10811393|NCT04130802|FG000|Participant Flow|OCS-01 1.5% mg/mL QD|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops~Placebo: Vehicle eye drops"
10811394|NCT04130802|FG001|Participant Flow|OCS-01 1.5% mg/mL BID|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811395|NCT04130802|FG002|Participant Flow|Placebo (Vehicle) BID|"eye drops~Placebo: Vehicle eye drops"
10811396|NCT04130802|OG000|Outcome|OCS-01 1.5% mg/mL QD|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811397|NCT04130802|OG001|Outcome|OCS-01 1.5% mg/mL BID|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811398|NCT04130802|OG002|Outcome|Placebo (Vehicle) BID|"eye drops~Placebo: Vehicle eye drops"
10811399|NCT04130802|OG000|Outcome|OCS-01 1.5% mg/mL QD|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops~Placebo: Vehicle eye drops"
10811400|NCT04130802|EG000|Reported Event|OCS-01 1.5% mg/mL QD|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811401|NCT04130802|EG001|Reported Event|OCS-01 1.5% mg/mL BID|"eye drops~OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops"
10811402|NCT04130802|EG002|Reported Event|Placebo (Vehicle) BID|"eye drops~Placebo: Vehicle eye drops"
10811403|NCT04105738|BG000|Baseline|Difficult Airways|Documented history of difficult airways.
10811404|NCT04105738|BG001|Baseline|Control (Not Difficult Airways)|Age matched with normal airways to be used as controls
10811405|NCT04105738|BG002|Baseline|Total|Total of all reporting groups
11205801|NCT02231177|EG001|Reported Event|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
10811406|NCT04105738|FG000|Participant Flow|Difficult Airways|Documented history of difficult airways.
11205802|NCT02231177|EG002|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
11205803|NCT02231580|BG000|Baseline|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
10811407|NCT04105738|FG001|Participant Flow|Control (Not Difficult Airways)|Age matched with normal airways to be used as controls
10811408|NCT04105738|OG000|Outcome|Difficult Airways|Documented history of difficult airways.
10811409|NCT04105738|OG001|Outcome|Control (Not Difficult Airways)|Age matched with normal airways to be used as controls
11205804|NCT02231580|BG001|Baseline|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
10811410|NCT04105738|EG000|Reported Event|Difficult Airways|Documented history of difficult airways.
11205805|NCT02231580|BG002|Baseline|Total Title|
11205806|NCT02231580|FG000|Participant Flow|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
11205807|NCT02231580|FG001|Participant Flow|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
11205808|NCT02231580|OG000|Outcome|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
11205809|NCT02231580|OG001|Outcome|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
11205810|NCT02231580|OG000|Outcome|BN82451B Cohort 1|Patients randomised to receive BN82451B in cohort 1 received doses ranging from 40 to 60 mg BN82451B orally b.i.d. for up to 28 days.
11205811|NCT02231580|OG001|Outcome|BN82451B Cohort 2|Patients randomised to receive BN82451B in cohort 2 received doses ranging from 60 to 80 mg BN82451B orally b.i.d. for up to 28 days.
11205812|NCT02231580|EG000|Reported Event|BN82451B|"Patients were randomised to receive oral study medication, BN82451B, b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of BN82451B was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 milligrams (mg) b.i.d.~For cohort 1, 40 mg BN82451B b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg BN82451B b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg BN82451B b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
11205813|NCT02231580|EG001|Reported Event|Placebo|"Patients were randomised to receive oral placebo b.i.d. from Day 1 to Day 27, under double-blinded conditions. On Day 28 only one morning dose of placebo was administered. It was planned for patients to be assigned to 3 cohorts to receive 3 dose levels ranging between 40 and 80 mg b.i.d.~For cohort 1, 40 mg placebo b.i.d. was administered during the first 14 days. If this dose was well tolerated then it was increased to 60 mg b.i.d. for 13 days and one morning dose of 60 mg on Day 28.~For cohort 2, 60 mg placebo b.i.d. was administered during the first 14 days. If 60 mg b.i.d was well tolerated then it was increased to 80 mg b.i.d. for 13 days and one morning dose of 80 mg on Day 28.~For cohort 3 it was planned to administer 80 mg placebo b.i.d for 27 days with one morning dose of 80 mg on Day 28. The study was terminated early before completion of cohort 2."
10811411|NCT04105738|EG001|Reported Event|Control (Not Difficult Airways)|Age matched with normal airways to be used as controls
10811412|NCT04022733|BG000|Baseline|Moderate NMB Group|Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
11205814|NCT02231918|BG000|Baseline|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205815|NCT02231918|BG001|Baseline|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
10811413|NCT04022733|BG001|Baseline|Deep NMB Group|Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
11205816|NCT02231918|BG002|Baseline|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205817|NCT02231918|BG003|Baseline|Total|Total of all reporting groups
11205818|NCT02231918|FG000|Participant Flow|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205819|NCT02231918|FG001|Participant Flow|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205820|NCT02231918|FG002|Participant Flow|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205821|NCT02231918|OG000|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205822|NCT02231918|OG001|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205823|NCT02231918|OG002|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
10811414|NCT04022733|BG002|Baseline|Total|Total of all reporting groups
11205824|NCT02231918|EG000|Reported Event|MIRAPEX® (0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205825|NCT02231918|EG001|Reported Event|MIRAPEX® (0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205826|NCT02231918|EG002|Reported Event|MIRAPEX® (0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
11205827|NCT02232009|BG000|Baseline|3.0 T Neonatal Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures."
11205828|NCT02232009|FG000|Participant Flow|3.0 T Neonatal Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures."
11205829|NCT02232009|OG000|Outcome|3.0 T Neonatal Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures."
11205830|NCT02232009|EG000|Reported Event|3.0 T Neonatal Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures."
11205831|NCT02232022|BG000|Baseline|NonCryptogenic Ischemic Stroke Patients|"In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months.~Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities."
11215437|NCT02299258|EG001|Reported Event|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
10811415|NCT04022733|FG000|Participant Flow|Moderate NMB Group|Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
10811416|NCT04022733|FG001|Participant Flow|Deep NMB Group|Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
10811417|NCT04022733|OG000|Outcome|Moderate NMB Group|Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
10811418|NCT04022733|OG001|Outcome|Deep NMB Group|Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
10811419|NCT04022733|EG000|Reported Event|Moderate NMB Group|Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
10811420|NCT04022733|EG001|Reported Event|Deep NMB Group|Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
10811421|NCT04021524|BG000|Baseline|Hibiclens Soap|Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
10811422|NCT04021524|BG001|Baseline|BPO Soap|Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
10811423|NCT04021524|BG002|Baseline|Total|Total of all reporting groups
10811424|NCT04021524|FG000|Participant Flow|Hibiclens Soap|Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
10811425|NCT04021524|FG001|Participant Flow|BPO Soap|Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
10811426|NCT04021524|OG000|Outcome|Hibiclens Soap|Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
10811427|NCT04021524|OG001|Outcome|BPO Soap|Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
10811428|NCT04021524|EG000|Reported Event|Hibiclens Soap|Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
10811429|NCT04021524|EG001|Reported Event|BPO Soap|Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
10821670|NCT00070070|EG000|Reported Event|Cohort 1|"HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821671|NCT00070070|EG001|Reported Event|Cohort 2|"HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821672|NCT00070070|EG002|Reported Event|Cohort 3|"HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10821673|NCT00070070|EG003|Reported Event|Cohort 4|"HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.~NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after."
10822122|NCT00074581|FG000|Participant Flow|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
10822123|NCT00074581|FG001|Participant Flow|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
10811430|NCT03830359|BG000|Baseline|T2769|"T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily~T2769: 62 patients treated by T2769 for 42 days"
10811431|NCT03830359|FG000|Participant Flow|T2769|T2769 : 1 drop in each eye 3 to 6 times daily during 42 days
10811432|NCT03830359|OG000|Outcome|T2769|"T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily~T2769: 62 patients treated by T2769 for 42 days"
10811433|NCT03830359|EG000|Reported Event|T2769|T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily of T2769 for 42 days
10821674|NCT00070109|BG000|Baseline|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
10821675|NCT00070109|BG001|Baseline|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821676|NCT00070109|BG002|Baseline|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
11205832|NCT02232022|FG000|Participant Flow|NonCryptogenic Ischemic Stroke Patients|In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017. Patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.
10821677|NCT00070109|BG003|Baseline|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
11205833|NCT02232022|OG000|Outcome|NonCryptogenic Ischemic Stroke|Reveal LINQ Insertable Cardiac Monitor
11205834|NCT02232022|OG000|Outcome|NonCryptogenic Ischemic Stroke Patients|In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.
11205835|NCT02232022|OG000|Outcome|NonCryptogenic Ischemic Stroke Patients|Reveal LINQ Insertable Cardiac Monitor.
11205836|NCT02232022|EG000|Reported Event|NonCryptogenic Ischemic Stroke Patients|Reveal LINQ Insertable Cardiac Monitor
11205837|NCT02232061|BG000|Baseline|Fingolimod|Fingolimod 0.5mg/day tablets taken orally.
11205838|NCT02232061|FG000|Participant Flow|Fingolimod|Fingolimod 0.5mg/day tablets taken orally.
11205839|NCT02232061|OG000|Outcome|Fingolimod|Fingolimod 0.5mg/day tablets taken orally.
10821678|NCT00070109|BG004|Baseline|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821679|NCT00070109|BG005|Baseline|Total|Total of all reporting groups
10821680|NCT00070109|FG000|Participant Flow|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.~trabectedin: Given IV~pharmacological study: Correlative studies"
10821681|NCT00070109|FG001|Participant Flow|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
10821682|NCT00070109|FG002|Participant Flow|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821683|NCT00070109|FG003|Participant Flow|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821684|NCT00070109|FG004|Participant Flow|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821685|NCT00070109|OG000|Outcome|Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821686|NCT00070109|OG001|Outcome|Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821687|NCT00070109|OG002|Outcome|Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
11205840|NCT02232061|EG000|Reported Event|Fingolimod|Fingolimod 0.5mg/day tablets taken orally
11205841|NCT02232074|BG000|Baseline|Patient Navigation With Legal Support|For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.
11205842|NCT02232074|BG001|Baseline|Standard Patient Navigation|For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation
11205843|NCT02232074|BG002|Baseline|Total|Total of all reporting groups
11205844|NCT02232074|FG000|Participant Flow|Patient Navigation With Legal Support|For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.
10811434|NCT03675516|BG000|Baseline|Rheumatoid Arthritis Cases|"New onset cases of rheumatoid arthritis~No specific intervention: Usual care"
10811435|NCT03675516|BG001|Baseline|Controls|"Age, gender and primary care practice-matched controls~No specific intervention: Usual care"
10811436|NCT03675516|BG002|Baseline|Total|Total of all reporting groups
10811437|NCT03675516|FG000|Participant Flow|Rheumatoid Arthritis Cases|"New onset cases of rheumatoid arthritis~No specific intervention: Usual care"
10811438|NCT03675516|FG001|Participant Flow|Controls|"Age, gender and primary care practice-matched controls~No specific intervention: Usual care"
10811439|NCT03675516|OG000|Outcome|Rheumatoid Arthritis Cases|"New onset cases of rheumatoid arthritis~No specific intervention: Usual care"
10811440|NCT03675516|OG001|Outcome|Controls|"Age, gender and primary care practice-matched controls~No specific intervention: Usual care"
10811441|NCT03675516|OG001|Outcome|Controls|
10811442|NCT03675516|EG000|Reported Event|Rheumatoid Arthritis Cases|"New onset cases of rheumatoid arthritis~No specific intervention: Usual care"
10811443|NCT03675516|EG001|Reported Event|Controls|"Age, gender and primary care practice-matched controls~No specific intervention: Usual care"
10811444|NCT03605680|BG000|Baseline|Placebo: Single-blind Run-in Period Only|Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1) in the Run-in Period only. Participants did not continue to Double-blind Treatment Period.
10811445|NCT03605680|BG001|Baseline|Double-blind Treatment Period: Placebo + Centanafadine SR 200 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in Adult ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811446|NCT03605680|BG002|Baseline|Double-blind Treatment Period: Placebo + Centanafadine SR 400 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in Adult ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
10811447|NCT03605680|BG003|Baseline|Double-blind Treatment Period: Placebo + Placebo|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in Adult ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811448|NCT03605680|BG004|Baseline|Total|Total of all reporting groups
10811449|NCT03605680|FG000|Participant Flow|Single-blind (SB) Run-in Period: Placebo|Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1).
10811450|NCT03605680|FG001|Participant Flow|Double-blind Treatment Period: Centanafadine SR 200 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ASRS scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811451|NCT03605680|FG002|Participant Flow|Double-blind Treatment Period: Centanafadine SR 400 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ASRS scale score were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target total daily dose (TDD) of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
10811452|NCT03605680|FG003|Participant Flow|Double-blind Treatment Period: Placebo|Following Single-blind Run-in Period, participants with <30% improvement on ASRS scale score were randomized to receive centanafadine matching placebo SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811453|NCT03605680|OG000|Outcome|Double-blind Treatment Period: Centanafadine SR 200 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ASRS scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811454|NCT03605680|OG001|Outcome|Double-blind Treatment Period: Centanafadine SR 400 mg|Following Single-blind Run-in Period, participants with <30% improvement on Adult ASRS scale score were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
10811455|NCT03605680|OG002|Outcome|Double-blind Treatment Period: Placebo|Following Single-blind Run-in Period, participants with <30% improvement on Adult ASRS scale score were randomized to receive centanafadine matching placebo SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811456|NCT03605680|EG000|Reported Event|Placebo: SB Run-in Period Only|Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1) in the Single-blind Run-in Period only. Participants did not continue to Double-blind Treatment Period.
10811457|NCT03605680|EG001|Reported Event|Placebo + Centanafadine SR 200 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811458|NCT03605680|EG002|Reported Event|Placebo + Centanafadine SR 400 mg|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR 200 mg tablets BID orally on Day 1 through Day 7 and were then escalated to their target TDD of centanafadine 400 mg on Day 8 through Day 42 in the Double-blind Treatment Period.
10811459|NCT03605680|EG003|Reported Event|Placebo + Placebo|Participants received centanafadine SR matching placebo tablets in Single-blind Run-in Period. Participants who showed >=30% improvement in ASRS at Baseline were early terminated and the remaining participants were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
10811460|NCT03485950|BG000|Baseline|Ceftolozane/Tazobactam Arm|Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
10811461|NCT03485950|BG001|Baseline|Standard of Care (SOC) Arm|Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
10811462|NCT03485950|BG002|Baseline|Total|Total of all reporting groups
10811463|NCT03485950|FG000|Participant Flow|Ceftolozane/Tazobactam Arm|Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
10811464|NCT03485950|FG001|Participant Flow|Standard of Care (SOC) Arm|Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
10811465|NCT03485950|OG000|Outcome|Ceftolozane/Tazobactam Arm|Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
10811466|NCT03485950|OG001|Outcome|Standard of Care (SOC) Arm|Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
10811467|NCT03485950|EG000|Reported Event|Ceftolozane/Tazobactam Arm|Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
10811468|NCT03485950|EG001|Reported Event|Standard of Care (SOC) Arm|Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
11205845|NCT02232074|FG001|Participant Flow|Standard Patient Navigation|For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation
10821688|NCT00070109|OG003|Outcome|Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821689|NCT00070109|OG000|Outcome|Trabectedin 1.3 mg/m2- Feasibility in All Patients (Group 1)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
10821690|NCT00070109|OG001|Outcome|Trabectedin 1.5 mg/m2- Feasibility in All Patients (Group 2)|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
10821691|NCT00070109|OG000|Outcome|Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821692|NCT00070109|OG001|Outcome|Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821693|NCT00070109|OG002|Outcome|Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821694|NCT00070109|OG000|Outcome|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821695|NCT00070109|OG001|Outcome|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821696|NCT00070109|OG002|Outcome|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
10821697|NCT00070109|EG000|Reported Event|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
10821698|NCT00070109|EG001|Reported Event|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821699|NCT00070109|EG002|Reported Event|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821700|NCT00070109|EG003|Reported Event|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821701|NCT00070109|EG004|Reported Event|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
10821702|NCT00070135|BG000|Baseline|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
10847614|NCT00284089|EG003|Reported Event|Extension Group A+B: Ranibizumab 0.5 mg|In the extension phase, all patients received an intravitreal injection of 0.5 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
11205846|NCT02232074|OG000|Outcome|Breast Cancer Intervention|For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.
10811469|NCT03404518|BG000|Baseline|Norco and Ibuprofen|"This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.~Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control"
10811470|NCT03404518|BG001|Baseline|Ibuprofen and Norco|"This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.~Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control"
10811471|NCT03404518|BG002|Baseline|Total|Total of all reporting groups
10811472|NCT03404518|FG000|Participant Flow|Norco and Ibuprofen|"This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.~Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control"
10811473|NCT03404518|FG001|Participant Flow|Ibuprofen and Norco|"This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.~Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control"
10811474|NCT03404518|OG000|Outcome|Norco and Ibuprofen|"This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.~Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control"
10811475|NCT03404518|OG001|Outcome|Ibuprofen and Norco|"This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.~Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control"
10811476|NCT03404518|EG000|Reported Event|Norco and Ibuprofen|"This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.~Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control"
10811477|NCT03404518|EG001|Reported Event|Ibuprofen and Norco|"This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.~If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.~Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control"
10811478|NCT03370757|BG000|Baseline|3-hour Bundled Care|"Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.~3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week."
10811479|NCT03370757|BG001|Baseline|6-hour Bundled Care|"Infants in this group will have their diaper changed every 6 hours.~6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week."
10811480|NCT03370757|BG002|Baseline|Total|Total of all reporting groups
10811481|NCT03370757|FG000|Participant Flow|3-hour Bundled Care|"Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.~3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week."
10811482|NCT03370757|FG001|Participant Flow|6-hour Bundled Care|"Infants in this group will have their diaper changed every 6 hours.~6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week."
10811483|NCT03370757|OG000|Outcome|3-hour Bundled Care|"Infants in this group had their diaper changed every 3 hours during 3-hour bundled care.~3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours."
10811484|NCT03370757|OG001|Outcome|6-hour Bundled Care|"Infants in this group had their diaper changed every 6 hours.~6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours."
10811485|NCT03370757|OG000|Outcome|3-hour Bundled Care|"Infants in this group had their diaper changed every 3 hours.~3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours with trans epidermal water loss measurements taken 3 times per week."
10811486|NCT03370757|OG001|Outcome|6-hour Bundled Care|"Infants in this group had their diaper changed every 6 hours.~6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours with trans epidermal water loss measurements taken 4 times per week."
10811487|NCT03370757|EG000|Reported Event|3 Hour Bundled Care|Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.
10811488|NCT03370757|EG001|Reported Event|6 Hour Bundled Care|Infants in this group will have their diaper changed every 6 hours during 3-hour bundled care.
10821703|NCT00070135|FG000|Participant Flow|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
10847615|NCT00284141|BG000|Baseline|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
10811489|NCT03303989|BG000|Baseline|Pegloticase + MMF|"Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811490|NCT03303989|BG001|Baseline|Pegloticase + Placebo|"Participants randomized to this arm will receive pegloticase + placebo~Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811491|NCT03303989|BG002|Baseline|Total|Total of all reporting groups
10811492|NCT03303989|FG000|Participant Flow|Pegloticase + MMF|"Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811493|NCT03303989|FG001|Participant Flow|Pegloticase + Placebo|"Participants randomized to this arm will receive pegloticase + placebo~Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811494|NCT03303989|OG000|Outcome|Pegloticase + MMF|"Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811495|NCT03303989|OG001|Outcome|Pegloticase + Placebo|"Participants randomized to this arm will receive pegloticase + placebo~Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10847616|NCT00284141|FG000|Participant Flow|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
11205847|NCT02232074|OG001|Outcome|Breast Cancer Control|For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
10811496|NCT03303989|EG000|Reported Event|Pegloticase + MMF|"Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811497|NCT03303989|EG001|Reported Event|Pegloticase + Placebo|"Participants randomized to this arm will receive pegloticase + placebo~Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.~Pegloticase 8 MG/ML [Krystexxa]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months."
10811498|NCT03289143|BG000|Baseline|Placebo Double Blind Period|Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.
10811499|NCT03289143|BG001|Baseline|Dose 1 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.
10811500|NCT03289143|BG002|Baseline|Dose 2 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.
10811501|NCT03289143|BG003|Baseline|Dose 3 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
10811502|NCT03289143|BG004|Baseline|Total|Total of all reporting groups
10811503|NCT03289143|FG000|Participant Flow|Placebo Double Blind Period|Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.
10811504|NCT03289143|FG001|Participant Flow|Dose 1 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.
10811505|NCT03289143|FG002|Participant Flow|Dose 2 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.
10811506|NCT03289143|FG003|Participant Flow|Dose 3 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
10811507|NCT03289143|OG000|Outcome|Placebo Double Blind Period|Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.
10811508|NCT03289143|OG001|Outcome|Dose 1 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.
10811509|NCT03289143|OG002|Outcome|Dose 2 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.
10811510|NCT03289143|OG003|Outcome|Dose 3 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
10811511|NCT03289143|OG004|Outcome|Dose 2 Semorinemab Open Label Extension Period|Semorinemab was administered intravenously at dose 2 in the open-label extension period.
10811512|NCT03289143|OG000|Outcome|Dose 1 Semorinemab Double Blind and Open Label Extension Periods|Semorinemab was administered intravenously at dose 1 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.
10811513|NCT03289143|OG001|Outcome|Dose 2 Semorinemab Double Blind and Open Label Extension Periods|Semorinemab was administered intravenously at dose 2 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.
10811514|NCT03289143|OG002|Outcome|Dose 3 Semorinemab Double Blind and Open Label Extension Periods|Semorinemab was administered intravenously at dose 3 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.
10811515|NCT03289143|EG000|Reported Event|Placebo Double Blind Period|Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.
11205848|NCT02232074|OG000|Outcome|Lung Cancer Intervention|For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.
11205849|NCT02232074|OG001|Outcome|Lung Cancer Control|For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
10811516|NCT03289143|EG001|Reported Event|Dose 1 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.
10811517|NCT03289143|EG002|Reported Event|Dose 2 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.
11205850|NCT02232074|OG000|Outcome|Lung Cancer Intervention|For Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.
11205851|NCT02232074|OG001|Outcome|Lung Cancer Control|For Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
10811518|NCT03289143|EG003|Reported Event|Dose 3 Semorinemab Double Blind Period|Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.
10811519|NCT03289143|EG004|Reported Event|Dose 2 Semorinemab Open Label|Semorinemab was administered intravenously at dose 2 in the open-label extension period.
10811520|NCT03156504|BG000|Baseline|Ketamine|"Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers).~Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes."
10811521|NCT03156504|FG000|Participant Flow|Ketamine|"Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers).~Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes."
10811522|NCT03156504|OG000|Outcome|Ketamine|"Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers).~Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes."
10811523|NCT03156504|EG000|Reported Event|Ketamine|"Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers).~Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes."
10811524|NCT03006926|BG000|Baseline|DLT Part: Lenvatinib 12 mg or 8 mg + Pembrolizumab 200 mg|In DLT part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in Cycle 1 of a 21-day treatment cycle. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg. Participants who discontinued treatment in Cycle 1, entered the follow-up phase. Participants who were still receiving treatment at the end of Cycle 1, continued to receive same treatment until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Upon confirmation of the tolerability of the tested combination regimen of lenvatinib plus pembrolizumab in in Cycle 1, expansion part was opened for participant's enrolment.
10811525|NCT03006926|BG001|Baseline|Expansion Part: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|In the Expansion part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in 21-day treatment cycles until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10811526|NCT03006926|BG002|Baseline|Total|Total of all reporting groups
10811527|NCT03006926|FG000|Participant Flow|DLT Part: Lenvatinib 12 mg or 8 mg + Pembrolizumab 200 mg|In DLT part, participants received lenvatinib 12 milligram (mg) or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in Cycle 1 of a 21-day treatment cycle. Participants with body weight greater than or equal to (>=) 60 kilogram (kg) received lenvatinib 12 mg, participants with body weight less than (<) 60 kg, received lenvatinib 8 mg. Participants who discontinued treatment in Cycle 1, entered the follow-up phase. Participants who were still receiving treatment at the end of Cycle 1, continued to receive same treatment until progressive disease (PD), development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Upon confirmation of the tolerability of the tested combination regimen of lenvatinib plus pembrolizumab in in Cycle 1, expansion part was opened for participant's enrollment.
10811528|NCT03006926|FG001|Participant Flow|Expansion Part: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|In the Expansion part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in 21-day treatment cycles until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10811529|NCT03006926|OG000|Outcome|DLT Part: Lenvatinib 12 mg or 8 mg + Pembrolizumab 200 mg|In DLT part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in Cycle 1 of a 21-day treatment cycle. Participants with Body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg. Participants who discontinued treatment in Cycle 1, entered the follow up phase. Participants who were still receiving treatment at the end of Cycle 1, continued to receive same treatment until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
10811530|NCT03006926|OG000|Outcome|Expansion Part: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|In the Expansion part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, in 21-day treatment cycles until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10811531|NCT03006926|OG000|Outcome|HCC-1L: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|Participants received lenvatinib 8 or 12 mg, capsules, orally, once daily in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in 21-day treatment cycles as first line therapy until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10847617|NCT00284141|OG000|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
10847618|NCT00284141|OG001|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
10811532|NCT03006926|OG000|Outcome|HCC 1L: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|Participants received lenvatinib 8 or 12 mg, capsules, orally, once daily in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in 21-day treatment cycles as first line therapy until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10811533|NCT03006926|EG000|Reported Event|DLT Part: Lenvatinib 12 mg or 8 mg + Pembrolizumab 200 mg|In DLT part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in Cycle 1 of a 21-day treatment cycle. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg. Participants who discontinued treatment in Cycle 1, entered the follow-up phase. Participants who were still receiving treatment at the end of Cycle 1, continued to receive same treatment until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Upon confirmation of the tolerability of the tested combination regimen of lenvatinib plus pembrolizumab in in Cycle 1, expansion part was opened for participant's enrolment.
10811534|NCT03006926|EG001|Reported Event|Expansion Part: Lenvatinib 12 mg or 8 mg+ Pembrolizumab 200 mg|In the Expansion part, participants received lenvatinib 12 mg or 8 mg capsules, orally, once daily, in combination with pembrolizumab 200 mg, infusion, intravenously, every 3 weeks, in 21-day treatment cycles until PD, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants with body weight >=60 kg received lenvatinib 12 mg, participants with body weight <60 kg, received lenvatinib 8 mg.
10811535|NCT02993926|BG000|Baseline|Treatment Phase: Enantone|Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
10811536|NCT02993926|FG000|Participant Flow|Treatment Phase: Enantone|Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
10811537|NCT02993926|FG001|Participant Flow|Follow Up: Participants No Longer Treated for CPP|Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).
10811538|NCT02993926|FG002|Participant Flow|Follow Up: Treated With Non-Enantone GnRHa After Enantone|Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 [i.e. 1 day] to 12 months).
10811539|NCT02993926|OG000|Outcome|Treatment Phase: Enantone (Male)|Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
10811540|NCT02993926|OG001|Outcome|Treatment Phase: Enantone (Female)|Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
10811541|NCT02993926|OG000|Outcome|Follow UP: Participants No Longer Treated for CPP (Male)|Male participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).
10811542|NCT02993926|OG001|Outcome|Follow Up: Participants No Longer Treated for CPP (Female)|Female participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).
10811543|NCT02993926|OG002|Outcome|FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female|Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 [i.e. 1 day] to 12 months).
10811544|NCT02993926|EG000|Reported Event|Treatment Phase: Enantone|Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
10811545|NCT02993926|EG001|Reported Event|Follow Up: Participants No Longer Treated for CPP|Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).
10811546|NCT02993926|EG002|Reported Event|Follow Up: Treated With Non-Enantone GnRHa After Enantone|Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 [i.e. 1 day] to 12 months).
10811547|NCT02932579|BG000|Baseline|Standard of Care|"Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)"
10847619|NCT00284141|OG000|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
10847620|NCT00284141|EG000|Reported Event|4 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
10811548|NCT02932579|BG001|Baseline|Pharmacogenomic Group|"Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)~Ibuprofen: 400 mg~hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg~acetominophen: 650 mg~Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work."
10811549|NCT02932579|BG002|Baseline|Total|Total of all reporting groups
10811550|NCT02932579|FG000|Participant Flow|Standard of Care|"Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)"
10811551|NCT02932579|FG001|Participant Flow|Pharmacogenomic Group|"Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)~Ibuprofen: 400 mg~hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg~acetominophen: 650 mg~Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work."
10811552|NCT02932579|OG000|Outcome|Standard of Care|"Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)"
10811553|NCT02932579|OG001|Outcome|Pharmacogenomic Group|"Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)~Ibuprofen: 400 mg~hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg~acetominophen: 650 mg~Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work."
10811554|NCT02932579|EG000|Reported Event|Standard of Care|"Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)"
10811555|NCT02932579|EG001|Reported Event|Pharmacogenomic Group|"Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)~Pharmacogenomic Testing: Saliva collection (5mL)~Ibuprofen: 400 mg~hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg~acetominophen: 650 mg~Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work."
10811556|NCT02928224|BG000|Baseline|Combined Safety Lead-in (CSLI)|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811557|NCT02928224|BG001|Baseline|Phase 3: Triplet Arm|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811558|NCT02928224|BG002|Baseline|Phase 3: Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
10811559|NCT02928224|BG003|Baseline|Phase 3:Control Arm|"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.~Cetuximab: Standard of care.~Irinotecan: Standard of care.~Folinic Acid: Standard of care.~5-Fluorouracil: Standard of care."
10811560|NCT02928224|BG004|Baseline|Total|Total of all reporting groups
10811561|NCT02928224|FG000|Participant Flow|Combined Safety Lead-in|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811562|NCT02928224|FG001|Participant Flow|Phase 3: Triplet Arm|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811563|NCT02928224|FG002|Participant Flow|Phase 3: Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
11205852|NCT02232074|OG000|Outcome|Lung Cancer Intervention|Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.
10811564|NCT02928224|FG003|Participant Flow|Phase 3:Control Arm|"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.~Cetuximab: Standard of care.~Irinotecan: Standard of care.~Folinic Acid: Standard of care.~5-Fluorouracil: Standard of care."
10811565|NCT02928224|OG000|Outcome|Combined Safety Lead-in (CSLI)|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811566|NCT02928224|OG000|Outcome|Combined Safety Lead-in|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811567|NCT02928224|OG000|Outcome|Phase 3: Triplet Arm|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811568|NCT02928224|OG001|Outcome|Phase 3:Control Arm|"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.~Cetuximab: Standard of care.~Irinotecan: Standard of care.~Folinic Acid: Standard of care.~5-Fluorouracil: Standard of care."
10811569|NCT02928224|OG000|Outcome|Phase 3: Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
10811570|NCT02928224|OG001|Outcome|Phase 3: Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
10811571|NCT02928224|OG001|Outcome|Phase 3:Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
10811572|NCT02928224|OG002|Outcome|Phase 3:Control Arm|"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.~Cetuximab: Standard of care.~Irinotecan: Standard of care.~Folinic Acid: Standard of care.~5-Fluorouracil: Standard of care."
10811573|NCT02928224|OG000|Outcome|Phase 3: Triplet, Doublet and Control Arm|"Encorafenib + binimetinib + cetuximab.~Encorafenib + cetuximab.~Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab."
10811574|NCT02928224|EG000|Reported Event|Combined Safety Lead-in|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
11205853|NCT02232074|OG001|Outcome|Lung Cancer Control|Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
10811575|NCT02928224|EG001|Reported Event|Phase 3: Triplet Arm|"Encorafenib + binimetinib + cetuximab.~Encorafenib: Orally, once daily.~Binimetinib: Orally, twice daily.~Cetuximab: Standard of care."
10811576|NCT02928224|EG002|Reported Event|Phase 3: Doublet Arm|"Encorafenib + cetuximab.~Encorafenib: Orally, once daily.~Cetuximab: Standard of care."
10811577|NCT02928224|EG003|Reported Event|Phase 3:Control Arm|"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.~Cetuximab: Standard of care.~Irinotecan: Standard of care.~Folinic Acid: Standard of care.~5-Fluorouracil: Standard of care."
10811578|NCT02858154|BG000|Baseline|Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula|"All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive active comparator (oxygen by nasal cannula)~HFNC: All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA~Oxygen by Cannula: All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care) to control sleep apnea and desaturations"
10811579|NCT02858154|FG000|Participant Flow|HFNC Followed by Clinically Ordered Low Flow Oxygen Via Nasal Cannula|"All subjects received HFNC followed by clinically ordered low flow oxygen via nasal cannula.~HFNC: All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA~Low flow oxygen by nasal cannula: All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care in infants) to control sleep apnea and desaturations"
10811580|NCT02858154|OG000|Outcome|Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC|All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive low flow oxygen by nasal cannula.
10811581|NCT02858154|OG000|Outcome|Average AHI Diagnostic Study Compared to Average AHI With Improvement in OSA With Low Flow Oxygen|All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive low flow oxygen by nasal cannula.
10811582|NCT02858154|EG000|Reported Event|HFNC for the First 3-4 Hours of the Study Followed by Clinically Ordered Low Flow Oxygen.|All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then 6-8 hours of clinically ordered PSG with low flow oxygen by nasal cannula for the remainder of the study. Since both interventions were done on the same night the sleep study with the first 3-4 hours of the sleep study with HFNC and the remainder 6-8 hours with clinically ordered PSG with low flow oxygen via nasal cannula the adverse events are reported for the duration of the study interventions.
10811583|NCT02852967|BG000|Baseline|Belumosudil 200 mg QD + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811584|NCT02852967|BG001|Baseline|Belumosudil 200 mg BID (Twice Daily) + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
11205854|NCT02232074|EG000|Reported Event|Patient Navigation With Legal Support|For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.
11205855|NCT02232074|EG001|Reported Event|Standard Patient Navigation|For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation
11205856|NCT02232126|BG000|Baseline|Usual Care|Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital
11205857|NCT02232126|BG001|Baseline|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
10811585|NCT02852967|BG002|Baseline|Belumosudil 400 mg QD + Placebo|"Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811586|NCT02852967|BG003|Baseline|Belumosudil 600 mg/Day|"Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets"
10811587|NCT02852967|BG004|Baseline|Placebo|"Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening~Placebo: Placebo tablets matching belumosudil"
10811588|NCT02852967|BG005|Baseline|Total|Total of all reporting groups
10811589|NCT02852967|FG000|Participant Flow|Belumosudil 200 mg QD + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811590|NCT02852967|FG001|Participant Flow|Belumosudil 200 mg BID (Twice Daily) + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811591|NCT02852967|FG002|Participant Flow|Belumosudil 400 mg QD + Placebo|"Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
11205858|NCT02232126|BG002|Baseline|Total|Total of all reporting groups
11205859|NCT02232126|FG000|Participant Flow|Usual Care|
11205860|NCT02232126|FG001|Participant Flow|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
11205861|NCT02232126|OG000|Outcome|Usual Care|Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.
11205862|NCT02232126|OG001|Outcome|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
10811592|NCT02852967|FG003|Participant Flow|Belumosudil 600 mg/Day|"Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets"
10811593|NCT02852967|FG004|Participant Flow|Placebo|"Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening~Placebo: Placebo tablets matching belumosudil"
10811594|NCT02852967|OG000|Outcome|Belumosudil 200 mg QD + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811595|NCT02852967|OG001|Outcome|Belumosudil 200 mg BID (Twice Daily) + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811596|NCT02852967|OG002|Outcome|Belumosudil 400 mg QD + Placebo|"Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811597|NCT02852967|OG003|Outcome|Belumosudil 600 mg/Day|"Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets"
10811598|NCT02852967|OG004|Outcome|Placebo|"Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening~Placebo: Placebo tablets matching belumosudil"
10811599|NCT02852967|OG005|Outcome|All Belumosudil|All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
10811600|NCT02852967|OG004|Outcome|All Belumosudil|All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
10811601|NCT02852967|OG000|Outcome|Belumosudil 200 mg QD + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening~Belumosudil~Placebo: Placebo tablets matching belumosudil"
10811602|NCT02852967|OG001|Outcome|Belumosudil 200 mg BID (Twice Daily) + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil~Placebo: Placebo tablets matching belumosudil"
10811603|NCT02852967|OG002|Outcome|Belumosudil 400 mg QD + Placebo|"Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening~Belumosudil~Placebo: Placebo tablets matching belumosudil"
10811604|NCT02852967|OG003|Outcome|Belumosudil 600 mg/Day|"Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil"
10811605|NCT02852967|OG005|Outcome|All Belumosudile|All subjects from all cohorts who received belumosudil
10811606|NCT02852967|EG000|Reported Event|Belumosudil 200 mg QD + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811607|NCT02852967|EG001|Reported Event|Belumosudil 200 mg BID (Twice Daily) + Placebo|"One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811608|NCT02852967|EG002|Reported Event|Belumosudil 400 mg QD + Placebo|"Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening~Belumosudil: Belumosudil tablets~Placebo: Placebo tablets matching belumosudil"
10811609|NCT02852967|EG003|Reported Event|Belumosudil 600 mg/Day|"Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening~Belumosudil: Belumosudil tablets"
10811610|NCT02852967|EG004|Reported Event|Placebo|"Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening~Placebo: Placebo tablets matching belumosudil"
10811611|NCT02852967|EG005|Reported Event|All Belumosudil|All subjects from all cohorts who received belumosudil
10811612|NCT02810418|BG000|Baseline|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|"Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811613|NCT02810418|BG001|Baseline|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|"Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811614|NCT02810418|BG002|Baseline|Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|"Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811615|NCT02810418|BG003|Baseline|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811616|NCT02810418|BG004|Baseline|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
10811617|NCT02810418|BG005|Baseline|Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10847621|NCT00284154|BG000|Baseline|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
10847622|NCT00284154|FG000|Participant Flow|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
10847623|NCT00284154|OG000|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
10811618|NCT02810418|BG006|Baseline|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811619|NCT02810418|BG007|Baseline|Total|Total of all reporting groups
10811620|NCT02810418|FG000|Participant Flow|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811621|NCT02810418|FG001|Participant Flow|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|"Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811622|NCT02810418|FG002|Participant Flow|Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|"Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811623|NCT02810418|FG003|Participant Flow|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion
10811624|NCT02810418|FG004|Participant Flow|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles
10811625|NCT02810418|FG005|Participant Flow|Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811626|NCT02810418|FG006|Participant Flow|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811627|NCT02810418|OG000|Outcome|All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811628|NCT02810418|OG000|Outcome|All Participants in Arm A1, Dose Level-1, and Arm A1 Dose Level 1 Phase I Short Infusion|All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811629|NCT02810418|OG000|Outcome|All Participants in Arm B1 DL2 and Arm B1 DL 1 and Arm B1 DL3R Phase I 48-hr Continuous Infusion|"All participants in Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.~AND Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles AND Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion."
10847624|NCT00284154|EG000|Reported Event|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
10847625|NCT00284180|BG000|Baseline|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
11205863|NCT02232126|OG000|Outcome|Intervention Group: Received Intervention|Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
10811630|NCT02810418|OG000|Outcome|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811631|NCT02810418|OG001|Outcome|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811632|NCT02810418|OG002|Outcome|Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811633|NCT02810418|OG003|Outcome|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811634|NCT02810418|OG004|Outcome|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|"Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100~(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles"
10811635|NCT02810418|OG005|Outcome|Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811636|NCT02810418|OG006|Outcome|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811637|NCT02810418|OG000|Outcome|All Participants in Arm A1 Phase I Short Infusion|All participants in Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg, and Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel
10811638|NCT02810418|OG001|Outcome|All Participants in Arm A2, Phase 2 Short Infusion|All participants in Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel
10811639|NCT02810418|OG002|Outcome|All Participants in Arm B1 Phase I Continuous Infusion|All participants in Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion AND Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles AND Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811640|NCT02810418|OG003|Outcome|All Participants in Arm B2, Phase I 24-hr Continuous Infusion Combo|All participants in Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811641|NCT02810418|OG001|Outcome|All Participants in Arm A2 Phase 2 Short Infusion|All participants in Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel
10811642|NCT02810418|OG002|Outcome|All Participants in Arm B1 Phase I Continuous Infusion|"All participants in Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.~AND Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles AND Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion."
10811643|NCT02810418|OG000|Outcome|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|"Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811644|NCT02810418|OG001|Outcome|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|"Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
11205864|NCT02232126|OG001|Outcome|Intervention Group: Opt-outs|Patients randomized to the intervention group that refused the intervention.
10811645|NCT02810418|OG000|Outcome|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811646|NCT02810418|OG001|Outcome|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
10811647|NCT02810418|OG002|Outcome|Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811648|NCT02810418|OG000|Outcome|Arm A1, Dose Level 1 Phase I Grade 1|Grade 1 mild adverse events.
10811649|NCT02810418|OG001|Outcome|Arm A1, Dose Level 1 Phase I Grade 2|Grade 2 moderate adverse events.
10811650|NCT02810418|OG002|Outcome|Arm A1, Dose Level 1 Phase I Grade 3|Grade 3 severe or medically significant adverse events.
10811651|NCT02810418|OG003|Outcome|Arm A1, Dose Level-1 Phase I Grade 1|Grade 1 mild adverse events.
10811652|NCT02810418|OG004|Outcome|Arm A1, Dose Level-1 Phase I Grade 2|Grade 2 moderate adverse events.
10811653|NCT02810418|OG005|Outcome|Arm A1, Dose Level-1 Phase I Grade 3|Grade 3 severe or medically significant adverse events.
10811654|NCT02810418|OG006|Outcome|Arm A1, Dose Level-1 Phase I Grade 4|Grade 4 life-threatening adverse events.
10811655|NCT02810418|OG007|Outcome|Arm A2, Phase 2 Grade 2|Grade 2 moderate adverse events.
11205865|NCT02232126|EG000|Reported Event|Usual Care|Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.
10811656|NCT02810418|OG008|Outcome|Arm A2, Phase 2 Grade 1|Grade 1 mild adverse events.
10811657|NCT02810418|OG009|Outcome|Arm A2, Phase 2 Grade 3|Grade 3 severe or medically significant adverse events.
10811658|NCT02810418|OG010|Outcome|Arm A2, Phase 2 Grade 4|Grade 4 life-threatening adverse events.
10811659|NCT02810418|OG011|Outcome|Arm B1, Dose Level 2 Phase I Grade 2|Grade 2 moderate adverse events.
10811660|NCT02810418|OG012|Outcome|Arm B1, Dose Level 2 Phase I Grade 3|Grade 3 severe or medically significant adverse events.
10811661|NCT02810418|OG013|Outcome|Arm B1, Dose Level 2 Phase I Grade 4|Grade 4 life-threatening adverse events.
10811662|NCT02810418|OG014|Outcome|Arm B1, Dose Level 1 Phase I Grade 2|Grade 2 moderate adverse events.
10811663|NCT02810418|OG015|Outcome|Arm B1, Dose Level 3R Phase I Grade 2|Grade 2 moderate adverse events.
10811664|NCT02810418|OG016|Outcome|Arm B2 Phase I Grade 2|Grade 2 moderate adverse events.
10811665|NCT02810418|OG002|Outcome|Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|"Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811666|NCT02810418|OG004|Outcome|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles
10811667|NCT02810418|OG002|Outcome|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811668|NCT02810418|OG003|Outcome|Arm B1, DL1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
10811669|NCT02810418|OG004|Outcome|Arm B1, DL3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811670|NCT02810418|OG005|Outcome|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811671|NCT02810418|OG000|Outcome|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|All participants in Arm A1 DL1.
10811672|NCT02810418|OG001|Outcome|Arm A1 and Arm A2, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|All participants in Arms A1 & A2, DL-1
10811673|NCT02810418|OG000|Outcome|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
11205866|NCT02232126|EG001|Reported Event|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
11205867|NCT02232178|BG000|Baseline|2 100mg Xaracoll Implants|"Bupivacaine HCl implant~2 100mg Xaracoll implants"
11205868|NCT02232178|BG001|Baseline|3 100mg Xaracoll Implants|"Bupivacaine HCl implant~3 100mg Xaracoll implants"
10811674|NCT02810418|OG001|Outcome|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811675|NCT02810418|OG003|Outcome|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
10811676|NCT02810418|OG001|Outcome|Arms A1 & A2, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
10811677|NCT02810418|OG000|Outcome|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|All participants in Arm A1, DL1.
10811678|NCT02810418|OG001|Outcome|Arm A1 & A2, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|All participants in Arm A1, DL-1 and Arm A2, DL-1.
10811679|NCT02810418|OG001|Outcome|Arms A1 & A2, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|All participants in Arm A1, DL-1 and Arm A2.
10811680|NCT02810418|OG001|Outcome|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|All participants in Arm A1, DL-1 and Arm A2.
10811681|NCT02810418|EG000|Reported Event|Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100|"Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811682|NCT02810418|EG001|Reported Event|Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100|"Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811683|NCT02810418|EG002|Reported Event|Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100|"Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m^2 nab-paclitaxel~LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles"
10811684|NCT02810418|EG003|Reported Event|Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10|Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811685|NCT02810418|EG004|Reported Event|Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
10811686|NCT02810418|EG005|Reported Event|Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in|Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
10811687|NCT02810418|EG006|Reported Event|Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg|Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles.
10821704|NCT00070135|OG000|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
11205869|NCT02232178|BG002|Baseline|150mg Bupivacaine HCl Injection|"Bupivacaine HCl~150mg Bupivacaine HCl injection"
10847626|NCT00284180|BG001|Baseline|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
10847627|NCT00284180|BG002|Baseline|Total|Total of all reporting groups
11205870|NCT02232178|BG003|Baseline|Total|Total of all reporting groups
11205871|NCT02232178|FG000|Participant Flow|2 100mg Xaracoll Implants|"Bupivacaine HCl implant~2 100mg Xaracoll implants"
11205872|NCT02232178|FG001|Participant Flow|3 100mg Xaracoll Implants|"Bupivacaine HCl implant~3 100mg Xaracoll implants"
11205873|NCT02232178|FG002|Participant Flow|150mg Bupivacaine HCl Injection|"Bupivacaine HCl~150mg Bupivacaine HCl injection"
10811688|NCT02785991|BG000|Baseline|Patients With Atrial Fibrillation|Patients with paroxysmal and persistent atrial fibrillation who meet criteria to receive a cryoablation procedure.
10811689|NCT02785991|FG000|Participant Flow|Patients With Atrial Fibrillation|Patients With Atrial Fibrillation who meet the indication, according to current clinical practice guidelines, for the Balloon Cryoablation procedure.
10811690|NCT02785991|OG000|Outcome|Patients With Atrial Fibrillation|Patients with paroxysmal and persistent atrial fibrillation
10811691|NCT02785991|OG000|Outcome|Patients With Paroxysmal and Persistent Atrial Fibrillation|Patients with AF paroxysmal or persistent who meet the criteria for a cryoablation of pulmonary veins.
10811692|NCT02785991|EG000|Reported Event|Paroxysmal and Persistent Atrial Fibrillation|Patients with paroxysmal or persistent AF who meet the criteria for the crioablation of the pulmonary veins. Events analyzed globally, no per groups.
10811693|NCT02781584|BG000|Baseline|Cohort 1: SEL 18 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet orally once daily for 12 weeks
10811694|NCT02781584|BG001|Baseline|Cohort 2: FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received FIR 20 mg tablet orally once daily for 12 weeks
10811695|NCT02781584|BG002|Baseline|Cohort 3: CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received CILO 30 mg tablet once daily for 12 weeks
10811696|NCT02781584|BG003|Baseline|Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811697|NCT02781584|BG004|Baseline|Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811698|NCT02781584|BG005|Baseline|Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811699|NCT02781584|BG006|Baseline|Cohort 7: CILO 20 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
10811700|NCT02781584|BG007|Baseline|Cohort 8: CILO 30 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
10811701|NCT02781584|BG008|Baseline|Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811702|NCT02781584|BG009|Baseline|Cohort 10: FIR 20 mg + FENO 48 mg|Participants received FENO 48 mg tablet orally for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811703|NCT02781584|BG010|Baseline|Cohort 11: FIR 20 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811704|NCT02781584|BG011|Baseline|Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g|Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811705|NCT02781584|BG012|Baseline|Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811706|NCT02781584|BG013|Baseline|Total|Total of all reporting groups
10811707|NCT02781584|FG000|Participant Flow|Cohort 1: SEL 18 mg (Non-cirrhotic)|Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
10811708|NCT02781584|FG001|Participant Flow|Cohort 2: FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
10811709|NCT02781584|FG002|Participant Flow|Cohort 3: CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
10811710|NCT02781584|FG003|Participant Flow|Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811711|NCT02781584|FG004|Participant Flow|Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811712|NCT02781584|FG005|Participant Flow|Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811713|NCT02781584|FG006|Participant Flow|Cohort 7: CILO 20 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
10811714|NCT02781584|FG007|Participant Flow|Cohort 8: CILO 30 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
10811715|NCT02781584|FG008|Participant Flow|Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811716|NCT02781584|FG009|Participant Flow|Cohort 10: FIR 20 mg + FENO 48 mg|Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811717|NCT02781584|FG010|Participant Flow|Cohort 11: FIR 20 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811718|NCT02781584|FG011|Participant Flow|Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g|Participants received Vascepa® (VAS) 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10847628|NCT00284180|FG000|Participant Flow|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
10811719|NCT02781584|FG012|Participant Flow|Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811720|NCT02781584|OG000|Outcome|Cohort 1: SEL 18 mg (Non-cirrhotic)|Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
10811721|NCT02781584|OG001|Outcome|Cohort 2: FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
10811722|NCT02781584|OG002|Outcome|Cohort 3: CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
10811723|NCT02781584|OG003|Outcome|Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811724|NCT02781584|OG004|Outcome|Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811725|NCT02781584|OG005|Outcome|Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811726|NCT02781584|OG006|Outcome|Cohort 7: CILO 20 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
10811727|NCT02781584|OG007|Outcome|Cohort 8: CILO 30 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
10811728|NCT02781584|OG008|Outcome|Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811729|NCT02781584|OG009|Outcome|Cohort 10: FIR 20 mg + FENO 48 mg|Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811730|NCT02781584|OG010|Outcome|Cohort 11: FIR 20 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
11205874|NCT02232178|OG000|Outcome|2 100mg Xaracoll Implants|"Bupivacaine HCl implant~2 100mg Xaracoll implants"
10811731|NCT02781584|OG011|Outcome|Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g|Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811732|NCT02781584|OG012|Outcome|Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811733|NCT02781584|EG000|Reported Event|Cohort 1: SEL 18 mg (Non-cirrhotic)|Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
10811734|NCT02781584|EG001|Reported Event|Cohort 2: FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
10811735|NCT02781584|EG002|Reported Event|Cohort 3: CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
10811736|NCT02781584|EG003|Reported Event|Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811737|NCT02781584|EG004|Reported Event|Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811738|NCT02781584|EG005|Reported Event|Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)|Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
10811739|NCT02781584|EG006|Reported Event|Cohort 7: CILO 20 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
10811740|NCT02781584|EG007|Reported Event|Cohort 8: CILO 30 mg (Cirrhotic)|Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
10811741|NCT02781584|EG008|Reported Event|Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)|Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
10811742|NCT02781584|EG009|Reported Event|Cohort 10: FIR 20 mg + FENO 48 mg|Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
11205875|NCT02232178|OG001|Outcome|3 100mg Xaracoll Implants|"Bupivacaine HCl implant~3 100mg Xaracoll implants"
11205876|NCT02232178|OG002|Outcome|150mg Bupivacaine HCl Injection|"Bupivacaine HCl~150mg Bupivacaine HCl injection"
10811743|NCT02781584|EG010|Reported Event|Cohort 11: FIR 20 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10847629|NCT00284180|FG001|Participant Flow|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
11205877|NCT02232178|EG000|Reported Event|2 100mg Xaracoll Implants|"Bupivacaine HCl implant~2 100mg Xaracoll implants"
11205878|NCT02232178|EG001|Reported Event|3 100mg Xaracoll Implants|"Bupivacaine HCl implant~3 100mg Xaracoll implants"
11205879|NCT02232178|EG002|Reported Event|150mg Bupivacaine HCl Injection|"Bupivacaine HCl~150mg Bupivacaine HCl injection"
10811744|NCT02781584|EG011|Reported Event|Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g|Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811745|NCT02781584|EG012|Reported Event|Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg|Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
10811746|NCT02730130|BG000|Baseline|Pembrolizumab Plus Radiotherapy|"Subjects will receive pembrolizumab 200 mg as an IV infusion. RT begins D1 prior to dose 1 of Pembrolizumab. Pembrolizumab will be administered as a 30 minute IV infusion. Radiotherapy will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. The dose of radiation will be a standard regimen/fractionation used in palliation: 3000 cGy, delivered in five 600 cGy fractions within 5-7 days.~Pembrolizumab~Radiotherapy"
10811747|NCT02730130|FG000|Participant Flow|Pembrolizumab Plus Radiotherapy|"Subjects will receive pembrolizumab 200 mg as an IV infusion. RT begins D1 prior to dose 1 of Pembrolizumab. Pembrolizumab will be administered as a 30 minute IV infusion. Radiotherapy will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. The dose of radiation will be a standard regimen/fractionation used in palliation: 3000 cGy, delivered in five 600 cGy fractions within 5-7 days.~Pembrolizumab~Radiotherapy"
10811748|NCT02730130|OG000|Outcome|Pembrolizumab Plus Radiotherapy|"Subjects will receive pembrolizumab 200 mg as an IV infusion. RT begins D1 prior to dose 1 of Pembrolizumab. Pembrolizumab will be administered as a 30 minute IV infusion. Radiotherapy will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. The dose of radiation will be a standard regimen/fractionation used in palliation: 3000 cGy, delivered in five 600 cGy fractions within 5-7 days.~Pembrolizumab~Radiotherapy"
10811749|NCT02730130|EG000|Reported Event|Pembrolizumab Plus Radiotherapy|"Subjects will receive pembrolizumab 200 mg as an IV infusion. RT begins D1 prior to dose 1 of Pembrolizumab. Pembrolizumab will be administered as a 30 minute IV infusion. Radiotherapy will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. The dose of radiation will be a standard regimen/fractionation used in palliation: 3000 cGy, delivered in five 600 cGy fractions within 5-7 days.~Pembrolizumab~Radiotherapy"
10811750|NCT02714062|BG000|Baseline|Placebo|Days 1-56: Placebo
11205880|NCT02232243|BG000|Baseline|Initial: Hydroxychloroquine 400mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (200mg twice per day; 400mg total) was given to subjects for up to 14 days prior to surgery."
10811751|NCT02714062|BG001|Baseline|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
10811752|NCT02714062|BG002|Baseline|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
10811753|NCT02714062|BG003|Baseline|Total|Total of all reporting groups
10811754|NCT02714062|FG000|Participant Flow|Placebo|Days 1-56: Placebo
10811755|NCT02714062|FG001|Participant Flow|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
10811756|NCT02714062|FG002|Participant Flow|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
10811757|NCT02714062|OG000|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
10811758|NCT02714062|OG001|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
10811759|NCT02714062|OG000|Outcome|Placebo|Days 1-56: Placebo
10811760|NCT02714062|OG001|Outcome|VI-0521 Mid Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)"
10811761|NCT02714062|OG002|Outcome|VI-0521 Top Dose|"Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)"
11205881|NCT02232243|BG001|Baseline|Secondary: Hydroxychloroquine 800mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (400mg twice per day; 800mg total) was given to subjects for up to 14 days prior to surgery."
10811762|NCT02714062|EG000|Reported Event|Placebo|Placebo: Placebo, po once daily
10811763|NCT02714062|EG001|Reported Event|VI-0521 Mid Dose|VI-0521 Mid Dose: phentermine 7.5 mg and topiramate 46 mg, po once daily
10811764|NCT02714062|EG002|Reported Event|VI-0521 Top Dose|VI-0521 Top Dose: phentermine 15 mg and topiramate 92 mg, po once daily
10811765|NCT02707055|BG000|Baseline|PF-05190457, Then Placebo|Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
10811766|NCT02707055|BG001|Baseline|Placebo, Then PF-05190457|Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
10811767|NCT02707055|BG002|Baseline|Total|Total of all reporting groups
10811768|NCT02707055|FG000|Participant Flow|PF-05190457, Then Placebo|Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
10811769|NCT02707055|FG001|Participant Flow|Placebo, Then PF-05190457|Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
10811770|NCT02707055|OG000|Outcome|PF-05190457|Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days
10811771|NCT02707055|OG001|Outcome|Placebo|Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days
10811772|NCT02707055|EG000|Reported Event|PF-05190457|Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days
10811773|NCT02707055|EG001|Reported Event|Placebo|Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days
10811774|NCT02696759|BG000|Baseline|Blood & Fecal Collection|"Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy~Blood & Fecal Collection: Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package."
10811775|NCT02696759|FG000|Participant Flow|Blood & Fecal Collection|"Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy~Blood & Fecal Collection: Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package."
10811776|NCT02696759|OG000|Outcome|Blood & Fecal Collection|"Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy~Blood & Fecal Collection: Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package."
10811777|NCT02696759|EG000|Reported Event|Blood & Fecal Collection|"Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy~Blood & Fecal Collection: Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package."
10811778|NCT02656290|BG000|Baseline|Edwards Pericardial Aortic Bioprosthesis Model 11000A|Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
10811779|NCT02656290|FG000|Participant Flow|Edwards Pericardial Aortic Bioprosthesis Model 11000A|Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
10811780|NCT02656290|OG000|Outcome|Edwards Pericardial Aortic Bioprosthesis Model 11000A|Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
10811781|NCT02656290|EG000|Reported Event|Edwards Pericardial Aortic Bioprosthesis Model 11000A|Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
10811782|NCT02652130|BG000|Baseline|Remestemcel-L|All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
10811783|NCT02652130|FG000|Participant Flow|Remestemcel-L|All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
10811784|NCT02652130|OG000|Outcome|Remestemcel-L|All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
10811785|NCT02652130|EG000|Reported Event|Remestemcel-L|All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
10811786|NCT02616393|BG000|Baseline|Cohort A - Brain Metastases|"Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC who have progressed with BM~Tesevatinib"
10811787|NCT02616393|BG001|Baseline|Cohort B - Leptomeningeal Metastases|"Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC who have progressed with LM~Tesevatinib"
10811788|NCT02616393|BG002|Baseline|Cohort C - Brain Metastases at Initial Presentation|"Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC with BM at initial presentation~Tesevatinib"
10811789|NCT02616393|BG003|Baseline|Total|Total of all reporting groups
10811790|NCT02616393|FG000|Participant Flow|Cohort A (BM)|Subjects with brain metastases (BM) who received tesevatinib 300 mg orally (PO) once daily (QD)
10811791|NCT02616393|FG001|Participant Flow|Cohort B (LM)|Subjects with leptomeningeal metastases (LM) who received tesevatinib 300 mg PO QD
10811792|NCT02616393|FG002|Participant Flow|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation (BM-IP) who received tesevatinib 300 mg PO QD
10811793|NCT02616393|OG000|Outcome|Cohort A (BM)|Subjects with brain metastases (BM) who received tesevatinib 300 mg orally (PO) once daily (QD)
10811794|NCT02616393|OG001|Outcome|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation (BM-IP) who received tesevatinib 300 mg PO QD
10811795|NCT02616393|OG002|Outcome|Overall BM|All subjects with brain metastases who received tesevatinib 300 mg PO QD
10811796|NCT02616393|OG000|Outcome|Cohort B (LM)|Subjects with leptomeningeal metastases (LM) who received 300 mg PO QD
10811797|NCT02616393|OG000|Outcome|Cohort A (BM)|Subjects with brain metastases (BM) administered tesevatinib 300 mg orally (PO) once daily (QD)
10811798|NCT02616393|OG001|Outcome|Cohort B (LM)|Subjects with leptomeningeal metastases (LM) administered tesevatinib 300 mg orally (PO) once daily (QD)
10811799|NCT02616393|OG002|Outcome|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation (BM-IP) administered tesevatinib 300 mg orally (PO) once daily (QD)
10811800|NCT02616393|OG000|Outcome|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation (BM-IP) administered tesevatinib 300 mg orally (PO) once daily (QD)
10811801|NCT02616393|OG000|Outcome|Cohort A (BM)|subjects with brain metastases (BM) administered tesevatinib 300 mg orally (PO) once daily (QD)
10811802|NCT02616393|OG001|Outcome|Cohort B (LM)|Subjects with leptomeningeal metastases (LM) who were administered tesevatinib 300 mg orally (PO) once daily (QD)
10811803|NCT02616393|OG002|Outcome|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation who were administered 300 mg PO QD
11205882|NCT02232243|BG002|Baseline|Tertiary: Hydroxychloroquine 400mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (200mg twice per day; 400mg total) was given to subjects for up to 14 days prior to surgery."
11205883|NCT02232243|BG003|Baseline|Total|Total of all reporting groups
11205884|NCT02232243|FG000|Participant Flow|Initial: Hydroxychloroquine 400mg HCQ|These patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.
10811804|NCT02616393|OG000|Outcome|Cohort A - Brain Metastases|Tesevatinib administered at a dose of 300 mg PO QD to subjects with NSCLC who progressed with BM
11205885|NCT02232243|FG001|Participant Flow|Secondary: Hydroxychloroquine 800mg HCQ|These patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery.
10811805|NCT02616393|OG001|Outcome|Cohort B - Leptomeningeal Metastases|Tesevatinib administered at a dose of 300 mg PO QD to subjects with NSCLC who progressed with LM
10811806|NCT02616393|OG002|Outcome|Cohort C - Brain Metastases at Initial Presentation|Tesevatinib administered at a dose of 300 mg PO QD to subjects with NSCLC with BM at initial presentation
10811807|NCT02616393|OG000|Outcome|Cohort A (BM)|Subjects with brain metastases (BM) who were administered tesevatinib 300 mg orally (PO) once daily (QD)
10811808|NCT02616393|OG001|Outcome|Cohort B (LM)|Subjects with leptomeningeal metastases (LM) who were administered tesevatinib 300 mg PO QD
10811809|NCT02616393|OG002|Outcome|Cohort C (BM-IP)|Subjects with brain metastases at initial presentation (BM-IP) who were administered tesevatinib 300 mg PO QD
10811810|NCT02616393|OG003|Outcome|All Subjects (Cohorts A+B+C)|All subjects with BM, LM or BM-IP who were administered tesevatinib 300 mg PO QD
10811811|NCT02616393|EG000|Reported Event|Cohort A - Brain Metastases|Tesevatinib 300 mg administered orally (PO) once daily (QD) to subjects with NSCLC who have progressed with BM
10811812|NCT02616393|EG001|Reported Event|Cohort B - Leptomeningeal Metastases|Tesevatinib 300 mg administered PO to subjects with NSCLC who have progressed with LM
11205886|NCT02232243|FG002|Participant Flow|Tertiary: Hydroxychloroquine 400mg HCQ|Based on data from primary and secondary groups, these patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.
11205887|NCT02232243|OG000|Outcome|Initial: Hydroxychloroquine 400mg HCQ|"These initial 3 patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.~Hydroxychloroquine, 200mg twice dailiy: Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery."
11205888|NCT02232243|OG001|Outcome|Secondary: Hydroxychloroquine 800mg HCQ|"Based on data analysis from the initial patients, these patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery.~Hydroxychloroquine, 400mg twice daily: Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery."
11205889|NCT02232243|OG002|Outcome|Tertiary: Hydroxychloroquine 400mg HCQ|"Based on data from the primary and secondary groups, patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.~Hydroxychloroquine, 200mg twice dailiy: Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery."
11205890|NCT02232243|OG000|Outcome|All Patients|Optimal biological dose is calculated from aggregate data of all patients
10811813|NCT02616393|EG002|Reported Event|Cohort C - Brain Metastases at Initial Presentation|Tesevatinib 300 mg administered PO to subjects with NSCLC who presented initially with brain metastases
10811814|NCT02616393|EG003|Reported Event|All Subjects (Cohorts A+B+C)|Tesevatinib 300 mg administered PO to all subjects with NSCLC who had brain metastases and who had leptomeningeal metastases
10811815|NCT02602288|BG000|Baseline|AAR+Behavioral Intervention (EXP)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form.~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke~Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts~Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form."
10811816|NCT02602288|BG001|Baseline|AAR+Attention Control Intervention (CTL)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family.~Mobile phone nutrition application: Smartphone based application to support healthy eating habits"
10811817|NCT02602288|BG002|Baseline|Total|Total of all reporting groups
10811818|NCT02602288|FG000|Participant Flow|AAR+Behavioral Intervention (EXP)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form.~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke~Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts~Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form."
10811819|NCT02602288|FG001|Participant Flow|AAR+Attention Control Intervention (CTL)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family.~Mobile phone nutrition application: Smartphone based application to support healthy eating habits"
10811820|NCT02602288|OG000|Outcome|AAR+Behavioral Intervention (EXP)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form.~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke~Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts~Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form."
10811821|NCT02602288|OG001|Outcome|AAR+Attention Control Intervention (CTL)|"Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family.~Mobile phone nutrition application: Smartphone based application to support healthy eating habits"
10811822|NCT02602288|EG000|Reported Event|AAR+Behavioral Intervention (EXP)|"Ask. Advise. Refer (AAR): WIC clinic staff ask mothers about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parents' smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone-based application to support smoking cessation efforts. Nicotine polacrilex: Over-the-counter nicotine replacement therapy in gum or lozenge form.~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke~Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts~Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form."
10811823|NCT02602288|EG001|Reported Event|AAR+Attention Control Intervention (CTL)|"Ask. Advise. Refer (AAR): WIC clinic staff ask mothers about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone-based application to support healthy eating habits~Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources~Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family.~Mobile phone nutrition application: Smartphone based application to support healthy eating habits"
10811824|NCT02577523|BG000|Baseline|ND0612 Regimen 1 - 24-hr Infusion|Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
11205891|NCT02232243|EG000|Reported Event|Initial: Hydroxychloroquine 400mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (200mg twice daily; 400mg total) was given to subjects for up to 14 days prior to surgery."
11205892|NCT02232243|EG001|Reported Event|Secondary: Hydroxychloroquine 800mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (400mg twice daily; 800mg total) was given to subjects for up to 14 days prior to surgery."
11205893|NCT02232243|EG002|Reported Event|Tertiary: Hydroxychloroquine 400mg HCQ|"Hydroxychloroquine 14 days~Hydroxychloroquine: Hydroxychloroquine (200mg twice daily, 400mg total) was given to subjects for up to 14 days prior to surgery."
11205894|NCT02232425|BG000|Baseline|Drug: IX-01|"Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity~IX-01"
10847630|NCT00284180|OG000|Outcome|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
11205895|NCT02232425|BG001|Baseline|Placebo|"Two to four capsules administered orally, 1-6 hours prior to sexual activity~Placebo"
11205896|NCT02232425|BG002|Baseline|Total|Total of all reporting groups
11205897|NCT02232425|FG000|Participant Flow|Drug: IX-01|"Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity~IX-01"
11205898|NCT02232425|FG001|Participant Flow|Placebo|"Two to four capsules administered orally, 1-6 hours prior to sexual activity~Placebo"
11205899|NCT02232425|OG000|Outcome|Drug: IX-01|"Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity~IX-01"
11205900|NCT02232425|OG001|Outcome|Placebo|"Two to four capsules administered orally, 1-6 hours prior to sexual activity~Placebo"
11205901|NCT02232425|EG000|Reported Event|Drug: IX-01|"Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity~IX-01"
11205902|NCT02232425|EG001|Reported Event|Placebo|"Two to four capsules administered orally, 1-6 hours prior to sexual activity~Placebo"
11205903|NCT02232698|BG000|Baseline|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11205904|NCT02232698|BG001|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
10811825|NCT02577523|BG001|Baseline|ND0612 Regimen 2 - 14-hr Infusion|Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
10811826|NCT02577523|BG002|Baseline|Total|Total of all reporting groups
10811827|NCT02577523|FG000|Participant Flow|ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 1|"Dosing Regimen 1 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 24 hours~ND0612 (Levodopa/Carbidopa solution, 720/90 mg daily)"
11205905|NCT02232698|BG002|Baseline|Total|Total of all reporting groups
11205906|NCT02232698|FG000|Participant Flow|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11205907|NCT02232698|FG001|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11205908|NCT02232698|OG000|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11205909|NCT02232698|OG001|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11205910|NCT02232698|EG000|Reported Event|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
11215438|NCT02299297|BG000|Baseline|Tofacitinib|"Tofacitinib will be self-administered for 6 months, with the option to extend treatment up to an additional 6 months at the discretion of the principal investigator. Patients will then be followed for 6 months off the drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment.~Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily"
10811828|NCT02577523|FG001|Participant Flow|ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 2|"Dosing Regimen 2 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 14 hours~ND0612 (Levodopa/Carbidopa solution, 538/67 mg daily) + IR-LD/CD (oral Levodopa/Carbidopa, 150/15 mg in the morning)"
10811829|NCT02577523|OG000|Outcome|ND0612 Regimen 1 - 24-hr Infusion|Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
10811830|NCT02577523|OG001|Outcome|ND0612 Regimen 2 - 14-hr Infusion|Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
10811831|NCT02577523|EG000|Reported Event|ND0612 Regimen 1 - 24-hr Infusion|Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
11215439|NCT02299297|FG000|Participant Flow|Tofacitinib|"Tofacitinib will be self-administered for 6 months, with the option to extend treatment up to an additional 6 months at the discretion of the principal investigator. Patients will then be followed for 6 months off the drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment.~Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily"
11205911|NCT02232698|EG001|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
10811832|NCT02577523|EG001|Reported Event|ND0612 Regimen 2 - 14-hr Infusion|Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
10811833|NCT02563002|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811834|NCT02563002|BG001|Baseline|Standard of Care (SOC)|Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811835|NCT02563002|BG002|Baseline|Total|Total of all reporting groups
10811836|NCT02563002|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811837|NCT02563002|FG001|Participant Flow|Standard of Care (SOC)|Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811838|NCT02563002|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811839|NCT02563002|OG001|Outcome|Standard of Care (SOC)|Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811840|NCT02563002|EG000|Reported Event|Pembrolizumab First Course|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).
10811841|NCT02563002|EG001|Reported Event|Standard of Care (SOC) First Course|Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle.
10811842|NCT02563002|EG002|Reported Event|SOC Switched Over to Pembrolizumab|Eligible participants with documented disease progression following chemotherapy in SOC arm switched over to receive pembrolizumab for up to 35 cycles (approximately 2 years).
10811843|NCT02563002|EG003|Reported Event|Pembrolizumab-Second Course|Participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10811844|NCT02563002|EG004|Reported Event|SOC Switched Over to Pembrolizumab-Second Course|Participants who switched over from SOC and received pembrolizumab and subsequently stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
10847631|NCT00284180|OG001|Outcome|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
10847632|NCT00284180|EG000|Reported Event|Vinflunine|
10847633|NCT00284180|EG001|Reported Event|Vinflunine/Trastuzumab|
10847634|NCT00284518|BG000|Baseline|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
11215440|NCT02299297|OG000|Outcome|Tofacitinib|"Tofacitinib will be self-administered for 6 months, with the option to extend treatment up to an additional 6 months at the discretion of the principal investigator. Patients will then be followed for 6 months off the drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment.~Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily"
10811845|NCT02461225|BG000|Baseline|Erchonia® FX-635™|"The Erchonia® FX-635™ is made up of 3 independent 17 milliWatts (mW), 635 nanometers (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia® FX-635™: The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811846|NCT02461225|BG001|Baseline|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811847|NCT02461225|BG002|Baseline|Total|Total of all reporting groups
10811848|NCT02461225|FG000|Participant Flow|Erchonia® FX-635™|"The Erchonia® FX-635™ is made up of 3 independent 17 milliWatts (mW), 635 nanometers (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia® FX-635™: The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811849|NCT02461225|FG001|Participant Flow|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811850|NCT02461225|OG000|Outcome|Erchonia® FX-635™|"The Erchonia® FX-635™ is made up of 3 independent 17 milliWatts (mW), 635 nanometers (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia® FX-635™: The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811851|NCT02461225|OG001|Outcome|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811852|NCT02461225|EG000|Reported Event|Erchonia® FX-635™|"The Erchonia® FX-635™ is made up of 3 independent 17 milliWatts (mW), 635 nanometers (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia® FX-635™: The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10847635|NCT00284518|BG001|Baseline|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
10847636|NCT00284518|BG002|Baseline|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
10847637|NCT00284518|BG003|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
10847638|NCT00284518|BG004|Baseline|Total|Total of all reporting groups
10847639|NCT00284518|FG000|Participant Flow|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
11205912|NCT02232802|BG000|Baseline|Test IMP - Reference IMP|"These patients reveiced the following sequence:~Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).~Each dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.~Subjects remained in an upright position whilst receiving each dose and for 4 h afterwards.~There were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential. Female subjects of child bearing potential underwent a washout period of approximately 28 days."
11205913|NCT02232802|BG001|Baseline|Reference IMP - Test IMP|"These patients reveiced the following sequence:~Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).~Each dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.~Subjects remained in an upright position whilst receiving each dose and for 4 h afterwards.~There were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential.~Female subjects of child bearing potential underwent a washout period of approximately 28 days."
11205914|NCT02232802|BG002|Baseline|Total|Total of all reporting groups
11215441|NCT02299297|EG000|Reported Event|Tofacitinib|"Tofacitinib will be self-administered for 6 months, with the option to extend treatment up to an additional 6 months at the discretion of the principal investigator. Patients will then be followed for 6 months off the drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment.~Tofacitinib: Dosage/Frequency: 5mg - 10mg, oral, twice daily"
10811853|NCT02461225|EG001|Reported Event|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced."
10811854|NCT02427958|BG000|Baseline|Leuprorelin|Participants with body weight greater than or equal to (>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China.
10811855|NCT02427958|FG000|Participant Flow|Leuprorelin|Participants with body weight greater than or equal to (>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China.
10811856|NCT02427958|OG000|Outcome|Leuprorelin|Participants with body weight greater than or equal to (>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China.
10811857|NCT02427958|EG000|Reported Event|Leuprorelin|Participants with body weight greater than or equal to (>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China.
10811858|NCT02425826|BG000|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
10811859|NCT02425826|BG001|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
10811860|NCT02425826|BG002|Baseline|Total|Total of all reporting groups
10811861|NCT02425826|FG000|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
10811862|NCT02425826|FG001|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
10811863|NCT02425826|FG002|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
10811864|NCT02425826|OG000|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
10811865|NCT02425826|OG001|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
10811866|NCT02425826|OG000|Outcome|Placebo-Apremilast|Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
10811867|NCT02425826|OG000|Outcome|Apremilast|Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
10811868|NCT02425826|OG000|Outcome|Apremilast|Participants treated with placebo initially, completed Week 16, entered and treated with apremilast during the apremilast open-label extension phase.
10811869|NCT02425826|EG000|Reported Event|Placebo-Controlled Phase: Apremilast (Weeks 0-16)|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
10811870|NCT02425826|EG001|Reported Event|Placebo-Controlled Phase: Placebo (Weeks 0-16)|Participants initially randomized to identically matching placebo tablets PO BID during the placebo-controlled phase. (Weeks 0-16).
10811871|NCT02425826|EG002|Reported Event|Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)|Includes participants initially randomized to apremilast tablets BID in the placebo controlled phase and continued on apremilast (Apremilast/Apremilast), as well as those who were initially randomized to placebo and switched at week 16 (Placebo/Apremilast) to Apremilast 30 mg tablets BID during weeks 16-52
10811872|NCT02384239|BG000|Baseline|Palbociclib 100mg|Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811873|NCT02384239|BG001|Baseline|Palbociclib 125mg|Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
11215442|NCT02299336|BG000|Baseline|PRN (Pro re Nata)|"2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks~Aflibercept: pro re nata (PRN)~Focal Laser: Focal laser administered based on pre-specified criteria"
10811874|NCT02384239|BG002|Baseline|Total|Total of all reporting groups
10811875|NCT02384239|FG000|Participant Flow|Palbociclib 100mg|Palbociclib dose 100mg, and either fulvestrant (500 mg intramuscular injection (IM) on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
11215443|NCT02299336|FG000|Participant Flow|PRN (Pro re Nata)|"2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks~Aflibercept: pro re nata (PRN)~Focal Laser: Focal laser administered based on pre-specified criteria"
10811876|NCT02384239|FG001|Participant Flow|Palbociclib 125mg|Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811877|NCT02384239|OG000|Outcome|Palbociclib 100mg|Palbociclib dose 100mg, and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811878|NCT02384239|OG001|Outcome|Palbociclib 125mg|Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811879|NCT02384239|OG000|Outcome|Palbociclib 100mg|Treatment arm palbociclib dose 100mg + fulvestrant or tamoxifen
10811880|NCT02384239|EG000|Reported Event|Palbociclib 100mg|Palbociclib dose 100mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811881|NCT02384239|EG001|Reported Event|Palbociclib 125mg|Palbociclib dose 125mg and either fulvestrant (500 mg IM on days 1 and 15 in the first 28 days, then every 28 days thereafter) or tamoxifen (20 mg PO daily by physician choice)
10811882|NCT02356705|BG000|Baseline|Saline Placebo|"Control patients will receive intranasal saline~saline placebo: intranasal saline given as placebo"
10811883|NCT02356705|BG001|Baseline|Nasal Midazolam Only|"Patients will receive 0.2 mg/kg of intranasal midazolam~Midazolam: midazolam 0.2 mg/kg given intranasally"
10811884|NCT02356705|BG002|Baseline|Midazolam Plus Xylocaine|"Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.~Midazolam: midazolam 0.2 mg/kg given intranasally~xylocaine: intransal xylocaine given in conjunction with intranasal midazolam"
10811885|NCT02356705|BG003|Baseline|Total|Total of all reporting groups
10811886|NCT02356705|FG000|Participant Flow|Saline Placebo|"Control patients will receive intranasal saline~saline placebo: intranasal saline given as placebo"
10811887|NCT02356705|FG001|Participant Flow|Nasal Midazolam Only|"Patients will receive 0.2 mg/kg of intranasal midazolam~Midazolam: midazolam 0.2 mg/kg given intranasally"
10811888|NCT02356705|FG002|Participant Flow|Midazolam Plus Xylocaine|"Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.~Midazolam: midazolam 0.2 mg/kg given intranasally~xylocaine: intransal xylocaine given in conjunction with intranasal midazolam"
10811889|NCT02356705|OG000|Outcome|Saline Placebo|"Control patients will receive intranasal saline~saline placebo: intranasal saline given as placebo"
10811890|NCT02356705|OG001|Outcome|Nasal Midazolam Only|"Patients will receive 0.2 mg/kg of intranasal midazolam~Midazolam: midazolam 0.2 mg/kg given intranasally"
10811891|NCT02356705|OG002|Outcome|Midazolam Plus Xylocaine|"Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.~Midazolam: midazolam 0.2 mg/kg given intranasally~xylocaine: intransal xylocaine given in conjunction with intranasal midazolam"
10811892|NCT02356705|EG000|Reported Event|Saline Placebo|"Control patients will receive intranasal saline~saline placebo: intranasal saline given as placebo"
10811893|NCT02356705|EG001|Reported Event|Nasal Midazolam Only|"Patients will receive 0.2 mg/kg of intranasal midazolam~Midazolam: midazolam 0.2 mg/kg given intranasally"
10811894|NCT02356705|EG002|Reported Event|Midazolam Plus Xylocaine|"Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.~Midazolam: midazolam 0.2 mg/kg given intranasally~xylocaine: intransal xylocaine given in conjunction with intranasal midazolam"
10811895|NCT02353247|BG000|Baseline|No Intervention (Completed)|Completed the full study (at least 70%)
10811896|NCT02353247|BG001|Baseline|No Intervention (Did Not Complete)|Took med off protocol Responded to less than 70% of text messages
10811897|NCT02353247|BG002|Baseline|Intervention (Complete)|Completed the full study (at least 70%)
10811898|NCT02353247|BG003|Baseline|Intervention (Did Not Complete)|Non compliant with medication Requested medication off protocol
10811899|NCT02353247|BG004|Baseline|Consented, Never Assigned to Group|"Reasons include:~Minimal response, no show to visit Never responded, no show to visit Technical difficulties Desired to be off all medications Loss of phone privileges Never Got Texts Cell# Changed Too Busy Unknown"
10811900|NCT02353247|BG005|Baseline|Total|Total of all reporting groups
10811901|NCT02353247|FG000|Participant Flow|Study Arm|Intervention Group
10811902|NCT02353247|FG001|Participant Flow|Control Group|No intervention
10811903|NCT02353247|FG002|Participant Flow|Consented, Never Randomized|For various reasons (e.g., lost phone access), never responded to initial text survey. As a result, they were not randomized to groups nor tracked during study. Baseline data was collected immediately after consenting.
10811904|NCT02353247|OG000|Outcome|Control Group T1|Medicine free (months 1-3)
10811905|NCT02353247|OG001|Outcome|Control Group T2|Medicine free (months 4-6)
10811906|NCT02353247|OG002|Outcome|Control Group T3|Medicine free (months 7-9)
10811907|NCT02353247|OG003|Outcome|Intervention Group T1|Reported bothersome bleeding, medicine free (months 1-3)
10811908|NCT02353247|OG004|Outcome|Intervention Group T2|Reported bothersome bleeding, prescribed acetate (months 4-6)
10811909|NCT02353247|OG005|Outcome|Intervention Group T3|Reported bothersome bleeding, medicine free (months 7-9)
10811910|NCT02353247|EG000|Reported Event|Control Group T1|Did not receive medication (months 1-3)
10811911|NCT02353247|EG001|Reported Event|Control Group T2|Did not receive medication (months 4-6)
10811912|NCT02353247|EG002|Reported Event|Control Group T3|Did not receive medication (months 7-9)
10811913|NCT02353247|EG003|Reported Event|Intervention Group T1|Reported bothersome bleeding, prescribed acetate (months 1-3)
10811914|NCT02353247|EG004|Reported Event|Intervention Group T2|Reported bothersome bleeding, prescribed acetate (months 4-6)
10811915|NCT02353247|EG005|Reported Event|Intervention Group T3|Reported bothersome bleeding, prescribed acetate (months 7-9)
10811916|NCT02316002|BG000|Baseline|Pembrolizumab|"Pembrolizumab 200 mg every 3 weeks~Pembrolizumab"
10811917|NCT02316002|FG000|Participant Flow|Pembrolizumab|"Pembrolizumab 200 mg every 3 weeks~Pembrolizumab"
10811918|NCT02316002|OG000|Outcome|Pembrolizumab|"Pembrolizumab 200 mg every 3 weeks~Pembrolizumab"
10811919|NCT02316002|EG000|Reported Event|Pembrolizumab|"Pembrolizumab 200 mg every 3 weeks~Pembrolizumab"
11205915|NCT02232802|FG000|Participant Flow|Test IMP - Reference IMP|"These patients reveiced the following sequence:~Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).~Each dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.~Subjects remained in an upright position whilst receiving each dose and for 4 h afterwards.~There were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential. Female subjects of child bearing potential underwent a washout period of approximately 28 days."
11205916|NCT02232802|FG001|Participant Flow|Reference IMP - Test IMP|"These patients reveiced the following sequence:~Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).~Each dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.~Subjects remained in an upright position whilst receiving each dose and for 4 h afterwards.~There were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential.~Female subjects of child bearing potential underwent a washout period of approximately 28 days."
11205917|NCT02232802|OG000|Outcome|Enoxaparin Sodium Chemi (Test IMP)|Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).
10967067|NCT00891176|FG000|Participant Flow|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967068|NCT00891176|FG001|Participant Flow|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967069|NCT00891176|FG002|Participant Flow|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
11205918|NCT02232802|OG001|Outcome|Clexane (Reference IMP)|Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).
11205919|NCT02232802|EG000|Reported Event|Enoxaparin Sodium Chemi|"Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.~Enoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane"
10811920|NCT02021071|BG000|Baseline|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
10811921|NCT02021071|BG001|Baseline|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
10811922|NCT02021071|BG002|Baseline|Total|Total of all reporting groups
10811923|NCT02021071|FG000|Participant Flow|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
10811924|NCT02021071|FG001|Participant Flow|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
10811925|NCT02021071|OG000|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
10811926|NCT02021071|OG000|Outcome|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
10811927|NCT02021071|OG001|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
11205920|NCT02232802|EG001|Reported Event|Clexane|"Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.~Enoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane"
10811928|NCT02021071|EG000|Reported Event|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
10811929|NCT02021071|EG001|Reported Event|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
10811930|NCT02000622|BG000|Baseline|Olaparib 300 mg bd|
10811931|NCT02000622|BG001|Baseline|Chemotherapy|
10811932|NCT02000622|BG002|Baseline|Total|Total of all reporting groups
10811933|NCT02000622|FG000|Participant Flow|Olaparib 300 mg bd|
10811934|NCT02000622|FG001|Participant Flow|Chemotherapy|
10811935|NCT02000622|OG000|Outcome|Olaparib 300 mg bd|Olaparib 300 mg bd tablets
10811936|NCT02000622|OG001|Outcome|Chemotherapy|Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
10811937|NCT02000622|EG000|Reported Event|Olaparib 300 mg bd|Description (Arm-group)
10811938|NCT02000622|EG001|Reported Event|Chemotherapy|Description (Arm-group)
10811939|NCT01933932|BG000|Baseline|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
10811940|NCT01933932|BG001|Baseline|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
10811941|NCT01933932|BG002|Baseline|Total|Total of all reporting groups
10811942|NCT01933932|FG000|Participant Flow|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
10811943|NCT01933932|FG001|Participant Flow|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
10811944|NCT01933932|OG000|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
10811945|NCT01933932|OG001|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
10811946|NCT01933932|EG000|Reported Event|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
10811947|NCT01933932|EG001|Reported Event|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
10811948|NCT01927068|BG000|Baseline|Global Cohort 1|"The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
11205921|NCT02232893|BG000|Baseline|TU-100|"TU-100: 5g TID (15g/day)~TU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery."
11205922|NCT02232893|BG001|Baseline|Placebo|"Placebo TID~Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery."
11205923|NCT02232893|BG002|Baseline|Total|Total of all reporting groups
10811949|NCT01927068|BG001|Baseline|ISR Cohort 2|"Same patient population in Cohort 1, but cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811950|NCT01927068|BG002|Baseline|Total|Total of all reporting groups
10811951|NCT01927068|FG000|Participant Flow|Global Cohort 1|"The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811952|NCT01927068|FG001|Participant Flow|ISR Cohort 2|"The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811953|NCT01927068|OG000|Outcome|Global Cohort 1|"The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute"
10811954|NCT01927068|OG001|Outcome|Global ISR Cohort 2|"The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811955|NCT01927068|OG000|Outcome|Global ISR Cohort 2|"The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. Data were only collected from Cohort 2. All data for pre-specified Primary and Secondary Outcome Measures should be reported.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811956|NCT01927068|EG000|Reported Event|Global Cohort 1|"The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute"
10811957|NCT01927068|EG001|Reported Event|Global ISR Cohort 2|"The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1.~All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).~Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute."
10811958|NCT01883817|BG000|Baseline|Placebo|"Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks~Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)"
10811959|NCT01883817|BG001|Baseline|DHA Omega-3|"Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks~DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 12 weeks"
10811960|NCT01883817|BG002|Baseline|Total|Total of all reporting groups
10811961|NCT01883817|FG000|Participant Flow|Placebo|"Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks~Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)"
10811962|NCT01883817|FG001|Participant Flow|DHA Omega-3|"Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks~DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks"
10811963|NCT01883817|OG000|Outcome|Placebo|"Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks~Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)"
10811964|NCT01883817|OG001|Outcome|DHA Omega-3|"Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks~DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 12 weeks"
10811965|NCT01883817|EG000|Reported Event|Placebo|"Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks~Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)"
10811966|NCT01883817|EG001|Reported Event|DHA Omega-3|"Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks~DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 12 weeks"
11205924|NCT02232893|FG000|Participant Flow|Daikenchuto (TU-100)|"Daikenchuto (TU-100) 5g TID (15g/day)~Daikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery."
11205925|NCT02232893|FG001|Participant Flow|Placebo|"Placebo TID~Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery."
10811967|NCT01813435|BG000|Baseline|Experimental Treatment Strategy|"All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.~Dosage and frequency:~Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy"
10811968|NCT01813435|BG001|Baseline|Reference Treatment Strategy|"Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.~Dosage and frequency:~Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for"
11205926|NCT02232893|OG000|Outcome|TU-100|"TU-100: 5g TID (15g/day)~TU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery."
11205927|NCT02232893|OG001|Outcome|Placebo|"Placebo TID~Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery."
10811969|NCT01813435|BG002|Baseline|Total|Total of all reporting groups
10811970|NCT01813435|FG000|Participant Flow|Experimental Treatment Strategy|"All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.~Dosage and frequency:~Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy"
11205928|NCT02232893|EG000|Reported Event|Daikenchuto (TU-100)|"Daikenchuto (TU-100) 5g TID (15g/day)~Daikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery."
10811971|NCT01813435|FG001|Participant Flow|Reference Treatment Strategy|"Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.~Dosage and frequency:~Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy~Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for"
11205929|NCT02232893|EG001|Reported Event|Placebo|"Placebo TID~Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery."
11205930|NCT02232984|BG000|Baseline|All Study Patients|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
11205931|NCT02232984|FG000|Participant Flow|All Study Patients|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
11205932|NCT02232984|OG000|Outcome|All Study Patients|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
11205933|NCT02232984|OG000|Outcome|All Study Patients|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
11205934|NCT02232984|OG000|Outcome|Acuity Pro LV Lead Delivery System|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
11205935|NCT02232984|OG001|Outcome|Other LV Lead Delivery Systems|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
11205936|NCT02232984|EG000|Reported Event|All Study Patients|All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance.
11205937|NCT02233101|BG000|Baseline|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
11205938|NCT02233101|BG001|Baseline|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
11205939|NCT02233101|BG002|Baseline|Total|Total of all reporting groups
11205940|NCT02233101|FG000|Participant Flow|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
11205941|NCT02233101|FG001|Participant Flow|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
11205942|NCT02233101|OG000|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
11205943|NCT02233101|OG001|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
11205944|NCT02233101|EG000|Reported Event|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
10811972|NCT01813435|OG000|Outcome|Experimental Treatment Strategy|"All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.~Dosage and frequency:~Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy"
10811973|NCT01813435|OG001|Outcome|Reference Treatment Strategy|"Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.~Dosage and frequency:~Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy~Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for"
10811974|NCT01813435|EG000|Reported Event|Experimental Treatment Strategy|"All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.~Dosage and frequency:~Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy"
10811975|NCT01813435|EG001|Reported Event|Reference Treatment Strategy|"Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.~Dosage and frequency:~Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy~Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for"
10821705|NCT00070135|EG000|Reported Event|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover"
10821706|NCT00070291|BG000|Baseline|Cyclosporine|
10821707|NCT00070291|FG000|Participant Flow|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
10821708|NCT00070291|OG000|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
10821709|NCT00070291|EG000|Reported Event|Cyclosporine|High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
10821710|NCT00070317|BG000|Baseline|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
10847640|NCT00284518|FG001|Participant Flow|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
10811976|NCT01700439|BG000|Baseline|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
10811977|NCT01700439|FG000|Participant Flow|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
10811978|NCT01700439|OG000|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an Edwards INTUITY surgical aortic heart valve.
10811979|NCT01700439|OG000|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
10811980|NCT01700439|EG000|Reported Event|Edwards INTUITY Surgical Aortic Heart Valve|Subjects who received an INTUITY study surgical aortic heart valve.
10811981|NCT01690299|BG000|Baseline|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811982|NCT01690299|BG001|Baseline|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811983|NCT01690299|BG002|Baseline|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811984|NCT01690299|BG003|Baseline|Total|Total of all reporting groups
10811985|NCT01690299|FG000|Participant Flow|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811986|NCT01690299|FG001|Participant Flow|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811987|NCT01690299|FG002|Participant Flow|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811988|NCT01690299|FG003|Participant Flow|Placebo/Apremilast|Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
10811989|NCT01690299|FG004|Participant Flow|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
10811990|NCT01690299|FG005|Participant Flow|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
10811991|NCT01690299|OG000|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811992|NCT01690299|OG001|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811993|NCT01690299|OG001|Outcome|Etanercept 50mg Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
10811994|NCT01690299|OG001|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811995|NCT01690299|OG002|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
10811996|NCT01690299|OG002|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811997|NCT01690299|OG002|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811998|NCT01690299|OG001|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10811999|NCT01690299|OG002|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10812000|NCT01690299|OG000|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets PO BID and SC saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
10812001|NCT01690299|OG001|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
10812002|NCT01690299|OG002|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
10812003|NCT01690299|OG000|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
10812004|NCT01690299|EG000|Reported Event|Placebo (Week 0-16)|Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10812005|NCT01690299|EG001|Reported Event|Apremilast Plus Placebo Injection (Week 0-16)|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10812006|NCT01690299|EG002|Reported Event|Etanercept Plus Placebo Tablets (Week 0-16)|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
10812007|NCT01690299|EG003|Reported Event|Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
10812008|NCT01690299|EG004|Reported Event|APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
10812009|NCT01690299|EG005|Reported Event|Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
10812010|NCT01525329|BG000|Baseline|Solid Organ Transplant With AKs|Patients who underwent kidney or liver transplant within 2 years, and with at least 4 premalignant skin lesions on face, ears, scalp, forearms or dorsal hands. Patients will serve as their own control; one side of the body will be randomized to 5-FU plus PDT, and the other to PDT alone.
10812011|NCT01525329|BG001|Baseline|Actinic Keratoses|Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.
10812012|NCT01525329|BG002|Baseline|Total|Total of all reporting groups
10812013|NCT01525329|FG000|Participant Flow|Solid Organ Transplant With AKs|"Patients who underwent kidney or liver transplant within 2 years, and with at least 4 premalignant skin lesions on face, ears, scalp, forearms or dorsal hands. Patients will serve as their own control; one side of the body will be randomized to 5-FU plus PDT, and the other to PDT alone.~All patients will receive one cream, 5-Fluorouracil (5FU), and will apply it to the AKs on either the right or left side of the face/scalp (per randomization scheme), once daily for 6 d prior to PDT. The ability of AKs to produce PpIX will be measured at baseline by applying methyl-aminolevulinate (Metvixia® topical cream) to the selected AKs using a fluorescence dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of PpIX fluorescence will be taken. Then the two largest lesions (one on the left, one on the right) will be biopsied under local anesthesia, followed by red light PDT (lasting ~8 minutes). Biopsy sites will be shielded from light with a spot bandage."
10812014|NCT01525329|FG001|Participant Flow|Actinic Keratoses|"Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.~All patients will receive one cream, 5-Fluorouracil (5FU), and will apply it to the AKs on either the right or left side of the face/scalp (per randomization scheme), once daily for 6 d prior to PDT. The ability of AKs to produce PpIX will be measured at baseline by applying methyl-aminolevulinate (Metvixia® topical cream) to the selected AKs using a fluorescence dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of PpIX fluorescence will be taken. Then the two largest lesions (one on the left, one on the right) will be biopsied under local anesthesia, followed by red light PDT (lasting ~8 minutes). Biopsy sites will be shielded from light with a spot bandage."
10812015|NCT01525329|OG000|Outcome|Transplant With AKs; 5FU + PDT|Patient with solid organ transplant: half of body receiving combination therapy
10812016|NCT01525329|OG001|Outcome|Transplant With AKs; PDT Only|Patient with solid organ transplant: half of body receiving PDT alone
10812017|NCT01525329|OG002|Outcome|Normals With AKs; 5FU + PDT|Patient without any organ transplant: half of body receiving combination therapy
10812018|NCT01525329|OG003|Outcome|Normals With AKs; PDT Only|Patient without any organ transplant: half of body receiving PDT alone
10812019|NCT01525329|OG000|Outcome|PDT Only|Patients who did not receive 5-FU prior to PDT
11205945|NCT02233101|EG001|Reported Event|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
11205946|NCT02233296|BG000|Baseline|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
11205947|NCT02233296|BG001|Baseline|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
11205948|NCT02233296|BG002|Baseline|Total|Total of all reporting groups
11205949|NCT02233296|FG000|Participant Flow|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
11205950|NCT02233296|FG001|Participant Flow|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
11205951|NCT02233296|OG000|Outcome|Fed Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
10812020|NCT01525329|OG001|Outcome|5-FU Followed by PDT|Patients who received a week of topical 5-FU pretreatment prior to PDT
10812021|NCT01525329|EG000|Reported Event|Solid Organ Transplant With AKs|Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands.
10812022|NCT01525329|EG001|Reported Event|Actinic Keratoses|Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands.
10812023|NCT01482286|BG000|Baseline|Metformin|"Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.~Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart."
10812024|NCT01482286|BG001|Baseline|Dietary Restriction|"Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.~Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac"
10812025|NCT01482286|BG002|Baseline|Exercise|"Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.~Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).~The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch."
10812026|NCT01482286|BG003|Baseline|Control|Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
10812027|NCT01482286|BG004|Baseline|Total|Total of all reporting groups
10812028|NCT01482286|FG000|Participant Flow|Metformin|"Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.~Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart."
10812029|NCT01482286|FG001|Participant Flow|Dietary Restriction|"Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.~Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac"
10812030|NCT01482286|FG002|Participant Flow|Exercise|"Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.~Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).~The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch."
10812031|NCT01482286|FG003|Participant Flow|Control|Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
10812032|NCT01482286|OG000|Outcome|Metformin|"Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.~Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart."
10812033|NCT01482286|OG001|Outcome|Dietary Restriction|"Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.~Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac"
10812034|NCT01482286|OG002|Outcome|Exercise|"Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.~Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).~The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch."
10812035|NCT01482286|OG003|Outcome|Control|Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
10812036|NCT01482286|EG000|Reported Event|Metformin|"Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.~Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart."
10812037|NCT01482286|EG001|Reported Event|Dietary Restriction|"Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.~Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac"
10812038|NCT01482286|EG002|Reported Event|Exercise|"Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.~Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).~The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch."
10812039|NCT01482286|EG003|Reported Event|Control|Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
10812040|NCT01452152|BG000|Baseline|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
10812041|NCT01452152|BG001|Baseline|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
10812042|NCT01452152|BG002|Baseline|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
10812043|NCT01452152|BG003|Baseline|Total|Total of all reporting groups
10812044|NCT01452152|FG000|Participant Flow|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
10812045|NCT01452152|FG001|Participant Flow|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
10812046|NCT01452152|FG002|Participant Flow|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
10812047|NCT01452152|OG000|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
10812048|NCT01452152|OG001|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
10812049|NCT01452152|OG002|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
10812050|NCT01452152|EG000|Reported Event|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
10812051|NCT01452152|EG001|Reported Event|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
10812052|NCT01452152|EG002|Reported Event|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
10847641|NCT00284518|FG002|Participant Flow|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
10847642|NCT00284518|FG003|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
11205952|NCT02233296|OG001|Outcome|Fasted Condition|Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
11205953|NCT02233296|OG000|Outcome|Fed Condition|Data presented is all participants in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).
11205954|NCT02233296|OG001|Outcome|Fasted Condition|Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
11205955|NCT02233296|OG000|Outcome|Fed Condition (n=30)|Data presented is all participants in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
11205956|NCT02233296|OG001|Outcome|Fasted Condition (n=30)|Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
10847643|NCT00284518|OG000|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
11205957|NCT02233296|EG000|Reported Event|Fed Condition (n=30)|Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fed condition are considered equally.
11205958|NCT02233296|EG001|Reported Event|Fasted Condition (n=30)|Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fasted condition are considered equally.
11205959|NCT02233309|BG000|Baseline|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
11205960|NCT02233309|FG000|Participant Flow|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
11205961|NCT02233309|OG000|Outcome|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
11205962|NCT02233309|EG000|Reported Event|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
11205963|NCT02233413|BG000|Baseline|Non-active LLLT Helmet Application|"A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.~Non-active LLLT helmet application: LED helmet applied without light activated"
11205964|NCT02233413|BG001|Baseline|Active LLLT Helmet Application|"A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated~Active LLLT helmet application: LED helmet applied with light activated"
11205965|NCT02233413|BG002|Baseline|Total|Total of all reporting groups
11205966|NCT02233413|FG000|Participant Flow|Non-active LLLT Helmet Application|"A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.~Non-active LLLT helmet application: LED helmet applied without light activated"
11205967|NCT02233413|FG001|Participant Flow|Active LLLT Helmet Application|"A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated~Active LLLT helmet application: LED helmet applied with light activated"
11205968|NCT02233413|OG000|Outcome|Non-active LLLT Helmet Application|"A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.~Non-active LLLT helmet application: LED helmet applied without light activated"
11205969|NCT02233413|OG001|Outcome|Active LLLT Helmet Application|"A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated~Active LLLT helmet application: LED helmet applied with light activated"
10847644|NCT00284518|OG001|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
11205970|NCT02233413|EG000|Reported Event|Non-active LLLT Helmet Application|"A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.~Non-active LLLT helmet application: LED helmet applied without light activated"
10812095|NCT01313351|BG000|Baseline|InflammaDry Test|"Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.~RPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears"
10812096|NCT01313351|FG000|Participant Flow|Device Testing|"Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.~RPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears"
10812097|NCT01313351|OG000|Outcome|InflammaDry Sensitivity|Percentage of True Positives when compared to Clinical Assessment
10812098|NCT01313351|OG001|Outcome|InflammaDry Specificity|Percentage of True Negatives when compared to Clinical Assessment
10812099|NCT01313351|EG000|Reported Event|Device Testing|No adverse events reported
10812109|NCT01232283|BG000|Baseline|Apremilast|Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812110|NCT01232283|BG001|Baseline|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
10812111|NCT01232283|BG002|Baseline|Total|Total of all reporting groups
10812112|NCT01232283|FG000|Participant Flow|Apremilast|Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10812113|NCT01232283|FG001|Participant Flow|Placebo|Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
10812114|NCT01232283|FG002|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
10812115|NCT01232283|FG003|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
10812116|NCT01232283|FG004|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
10812117|NCT01232283|FG005|Participant Flow|APR-APR Re-randomized to APR|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
10812118|NCT01232283|FG006|Participant Flow|APR-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
10847645|NCT00284518|OG002|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
10847646|NCT00284518|OG003|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
10847647|NCT00284518|EG000|Reported Event|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
10812119|NCT01232283|FG007|Participant Flow|PBO-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants were to maintain apremilast 30 mg BID; those who were non-responders (having a response of <PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these non-responders received additional topicals or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation
10812120|NCT01232283|FG008|Participant Flow|Apremilast (Long-Term Extension Phase)|Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (weeks 16-32) and apremilast 30 mg tablets or placebo during the Randomized Withdrawal Phase were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
10812121|NCT01232283|FG009|Participant Flow|Placebo-Apremilast (Long-term Extension)|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched at Week 16 to apremilast 30 mg BID during the Maintenance Phase, received apremilast 30 mg PO BID during the Randomized Withdrawal Phase and then received apremilast 30 mg tablets BID in the long-term extension phase from weeks 52-260.
10812122|NCT01232283|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812123|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812124|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (weeks 0-16)
10812125|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812126|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812127|NCT01232283|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812128|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812129|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812130|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812131|NCT01232283|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10812132|NCT01232283|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
10812133|NCT01232283|OG000|Outcome|APR-APR Re-randomized to PBO|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
10812134|NCT01232283|OG001|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
10812135|NCT01232283|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812136|NCT01232283|OG000|Outcome|Apremilast|Participants who received apremilast 30 mg BID at any time during the study. Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260,
10812137|NCT01232283|OG000|Outcome|Apremilast|Participants who received apremilast 30 mg BID at any time during the study.
10812138|NCT01232283|EG000|Reported Event|Placebo: Weeks 0-16 (PBO-Controlled Phase)|Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812139|NCT01232283|EG001|Reported Event|Apremilast: Weeks 0-16 (PBO-Controlled Phase)|Participants randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812140|NCT01232283|EG002|Reported Event|APR-APR-PBO: Weeks 32-52 (Randomized Withdrawal Phase)|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
10847648|NCT00284518|EG001|Reported Event|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
10847649|NCT00284518|EG002|Reported Event|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
10847650|NCT00284518|EG003|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
10812141|NCT01232283|EG003|Reported Event|Apremilast: Weeks 0-260 (APR- Exposure Period )|Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 260. Adverse events associated with apremilast 30 mg treatment up to Week 260 were included. AEs that started more than 28 days after placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
10812142|NCT01231516|BG000|Baseline|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
10812143|NCT01231516|BG001|Baseline|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available.
10812144|NCT01231516|BG002|Baseline|Total|Total of all reporting groups
10812145|NCT01231516|FG000|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
10812146|NCT01231516|FG001|Participant Flow|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available.
10812147|NCT01231516|OG000|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
10812148|NCT01231516|OG001|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available.
10812149|NCT01231516|EG000|Reported Event|DTG~50mg QD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
10812150|NCT01231516|EG001|Reported Event|RAL~400mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available.
10812151|NCT01229943|BG000|Baseline|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.> > Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812152|NCT01229943|BG001|Baseline|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.>~> Bevacizumab: Given IV>~> Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812153|NCT01229943|BG002|Baseline|Total|Total of all reporting groups
10812154|NCT01229943|FG000|Participant Flow|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.> > Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812155|NCT01229943|FG001|Participant Flow|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.>~> Bevacizumab: Given IV>~> Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812156|NCT01229943|OG000|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.> > Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812157|NCT01229943|OG001|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.>~> Bevacizumab: Given IV>~> Everolimus: Given PO>~> Octreotide Acetate: Given IM"
10812158|NCT01229943|OG000|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
10812159|NCT01229943|OG001|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
10812160|NCT01229943|EG000|Reported Event|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
10812161|NCT01229943|EG001|Reported Event|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
10812162|NCT01194219|BG000|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10812163|NCT01194219|BG001|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
10812164|NCT01194219|BG002|Baseline|Total|Total of all reporting groups
10812165|NCT01194219|FG000|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10812166|NCT01194219|FG001|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
10812167|NCT01194219|FG002|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
10812168|NCT01194219|FG003|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg tablets BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32)
10812169|NCT01194219|FG004|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders [ie, having a ≥ Psoriasis Area and Severity Index score of 75 (PASI-75) response] were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until week 52. Those participants who lost their PASI-75 improvement achieved at week 32, were switched back to APR 30 mg BID at the time loss of effect was observed. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260, and received APR 30 mg BID for the remainder of their participation.
10812170|NCT01194219|FG005|Participant Flow|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR 30 mg BID during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
10812171|NCT01194219|FG006|Participant Flow|APR-APR-APR + Optional Topicals/UVB|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
10812172|NCT01194219|FG007|Participant Flow|PBO-APR-APR + Optional Topicals/ UVB|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants continued to receive APR 30mg BID. Those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) or non-responders (ie, having a response of < PASI-50) were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
10812173|NCT01194219|FG008|Participant Flow|Apremilast (Long-term Extension)|Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (Weeks 16-32) and were re-randomized to APR 30 mg tablets or placebo tablets BID during the Randomized Withdrawal Phase; participants were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received APR 30 mg BID for the remainder of their participation.
10812174|NCT01194219|FG009|Participant Flow|Placebo-Apremilast (Long-term Extension)|Participants who were initially randomized to identically matching placebo BID during the placebo-controlled phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg tablets BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32) and Randomized Withdrawal Phase were eligible to participate in the Long-term Extension phase from Weeks 52-260 and continued on apremilast 30 mg tablets BID for the remainder of their participation.
10812175|NCT01194219|OG000|Outcome|Placebo/Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
10812176|NCT01194219|OG001|Outcome|Placebo (PBO)|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
10812177|NCT01194219|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast 30mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812178|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812179|NCT01194219|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812180|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812181|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
10812182|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16).
10812183|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812184|NCT01194219|OG000|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase (Weeks 0-16) continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR 30 mg BID during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
10812185|NCT01194219|OG001|Outcome|APR-APR -Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until Week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed.
10812186|NCT01194219|OG000|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812187|NCT01194219|OG001|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
10812188|NCT01194219|OG000|Outcome|Apremilast|Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants continued to receive apremilast 30 mg BID or were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260,
10812189|NCT01194219|OG000|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812190|NCT01194219|OG001|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812191|NCT01194219|OG000|Outcome|Apremilast|Participants initially randomized to placebo or apremilast 30 mg tablets BID during the 16-week placebo-controlled phase (Weeks 0-16) continued to receive apremilast 30 mg BID through the maintenance phase; during the randomized withdrawal phase (Weeks 32-52) participants continued to receive apremilast 30 mg BID or were again randomized to either apremilast 30 mg BID or placebo and were transitioned to apremilast 30 mg BID after loss of response or in the long-term extension phase from Weeks 52-260
10812192|NCT01194219|EG000|Reported Event|Placebo (Placebo-Controlled Phase) Weeks 0-16|Participants randomized and received identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
10812193|NCT01194219|EG001|Reported Event|Apremilast (Placebo-Controlled Phase) Weeks 0-16|Participants randomized and received apremilast 30 mg tablets BID during the Placebo-Controlled Phase (Weeks 0-16)
10812194|NCT01194219|EG002|Reported Event|APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52|Participants re-randomized and received placebo tablets BID at Week 32. Data from Week 32 up to Week 52 when participants received placebo treatment.
10812195|NCT01194219|EG003|Reported Event|Apremilast (Apremilast Exposure Period) Weeks 0-260|Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at week 16), up until Week 260. Adverse events associated with apremilast treatment up to Week 260 were included. AEs that started more than 28 days after Placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
10812196|NCT01193842|BG000|Baseline|Phase I: VR-DA-EPOCH, Dose Level 1|Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
10812197|NCT01193842|BG001|Baseline|Phase I: VR-DA-EPOCH, Dose Level 2|Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
10812198|NCT01193842|BG002|Baseline|Phase I: VR-CHOP, Dose Level 1|Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812199|NCT01193842|BG003|Baseline|Phase II, V+DA-EPOCH|Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
10812200|NCT01193842|BG004|Baseline|Phase II, DA-R-EPOCH|Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
10812201|NCT01193842|BG005|Baseline|Total|Total of all reporting groups
10812202|NCT01193842|FG000|Participant Flow|Phase I: VR-DA-EPOCH, Dose Level 1|Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
10812203|NCT01193842|FG001|Participant Flow|Phase I: VR-DA-EPOCH, Dose Level 2|Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
10812204|NCT01193842|FG002|Participant Flow|Phase I: VR-CHOP, Dose Level 1|Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812205|NCT01193842|FG003|Participant Flow|Phase II: VR-DA-EPOCH|Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
10812206|NCT01193842|FG004|Participant Flow|Phase II: DA-R-EPOCH|Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
10812207|NCT01193842|OG000|Outcome|Phase II: VR-DA-EPOCH|Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
10812208|NCT01193842|OG001|Outcome|Phase II: DA-R-EPOCH|Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
10812209|NCT01193842|OG000|Outcome|Phase I: VR-DA-EPOCH|Phase I, Arm A (VR-DA-EPOCH)
10812210|NCT01193842|OG000|Outcome|Phase I: VR-DA-EPOCH, Dose Level 1|Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
10812211|NCT01193842|OG001|Outcome|Phase I: VR-DA-EPOCH, Dose Level 2|Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
10812212|NCT01193842|OG002|Outcome|Phase I: VR-CHOP, Dose Level 1|Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812213|NCT01193842|OG002|Outcome|Phase I: VR-CHOP, Dose Level 1|Phase I, Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812214|NCT01193842|OG000|Outcome|Phase I: VR-DA-EPOCH, Dose Level 1|Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
10812215|NCT01193842|OG001|Outcome|Phase I: VR-DA-EPOCH, Dose Level 2|Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
10812216|NCT01193842|OG002|Outcome|Phase I: Arm C (VR-CHOP) Dose Level 1|Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812217|NCT01193842|EG000|Reported Event|Phase I: VR-DA-EPOCH, Dose Level 1|Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
10812218|NCT01193842|EG001|Reported Event|Phase I: VR-DA-EPOCH, Dose Level 2|Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
10812219|NCT01193842|EG002|Reported Event|Phase I: VR-CHOP, Dose Level 1|Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
10812220|NCT01193842|EG003|Reported Event|Phase II: VR-DA-EPOCH|Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
10812221|NCT01193842|EG004|Reported Event|Phase II: DA-R-EPOCH|Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat
10812222|NCT00855803|BG000|Baseline|Total Population|All patients enrolled to the study
10812223|NCT00855803|FG000|Participant Flow|Total Population|All patients enrolled to the study
10812224|NCT00855803|OG000|Outcome|Total Population|All patients enrolled to the study
10812225|NCT00855803|EG000|Reported Event|Total Population|All patients enrolled to the study
10812226|NCT00790803|BG000|Baseline|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
10812227|NCT00790803|FG000|Participant Flow|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
10812228|NCT00790803|OG000|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
10812229|NCT00790803|EG000|Reported Event|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
10812230|NCT00740116|BG000|Baseline|Tranexamic Group|"Tranexamic acid~Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery"
10812231|NCT00740116|BG001|Baseline|Placebo Group|"0.9% NaCl solution~0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery."
10812232|NCT00740116|BG002|Baseline|Total|Total of all reporting groups
10812233|NCT00740116|FG000|Participant Flow|Tranexamic Group|"Tranexamic acid~Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery"
10812234|NCT00740116|FG001|Participant Flow|Placebo Group|"0.9% NaCl solution~0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery."
10812235|NCT00740116|OG000|Outcome|Tranexamic Group|"Tranexamic acid~Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery"
10812236|NCT00740116|OG001|Outcome|Placebo Group|"0.9% NaCl solution~0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery."
10812237|NCT00740116|OG000|Outcome|The Placebo Group|"The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery~0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery."
10812238|NCT00740116|OG001|Outcome|The Tranexamic Acid Group|"The group of women receiving Tranexamic acid intravenously immediately before the surgery~Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery"
10812239|NCT00740116|EG000|Reported Event|Tranexamic Group|"Tranexamic acid~Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery"
10812240|NCT00740116|EG001|Reported Event|Placebo Group|"0.9% NaCl solution~0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery."
11205971|NCT02233413|EG001|Reported Event|Active LLLT Helmet Application|"A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated~Active LLLT helmet application: LED helmet applied with light activated"
10812241|NCT00565617|BG000|Baseline|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.~For further description of arm please refer to published paper Ziad Nahas, Berry S. Anderson, Jeff Borckardt, Ashley B. Arana, Mark S. George, Scott T. Reeves, and Istvan Takacs Bilateral Epidural Prefrontal Cortical Stimulation for Treatment- Resistant Depression Biological Psychiatry. 2010"
10812242|NCT00565617|FG000|Participant Flow|Epidural Cortical Stimulation Device for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
10812243|NCT00565617|OG000|Outcome|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
10812244|NCT00565617|EG000|Reported Event|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
10812245|NCT00470704|BG000|Baseline|Cohort 1|"This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year.~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812246|NCT00470704|BG001|Baseline|Cohort 2|"This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812247|NCT00470704|BG002|Baseline|Total|Total of all reporting groups
10812248|NCT00470704|FG000|Participant Flow|Cohort 1|"This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year.~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812249|NCT00470704|FG001|Participant Flow|Cohort 2|"This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812250|NCT00470704|OG000|Outcome|Cohort 1|"This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year.~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812251|NCT00470704|OG001|Outcome|Cohort 2|"This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib: Oral dose taken daily~Herceptin: Given intravenously once a week or once every 3 weeks"
10812252|NCT00470704|EG000|Reported Event|Cohort 1|"This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year.~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib~Herceptin"
10812253|NCT00470704|EG001|Reported Event|Cohort 2|"This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy~1000 mg daily Lapatinib~2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab~Lapatinib~Herceptin"
10812254|NCT00427193|BG000|Baseline|Caloric Restriction (CR)|"25% caloric restriction~Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months"
10812255|NCT00427193|BG001|Baseline|Ad Libitum|"Ad libitum energy intake~Control: Participants continue their current diet for 24 months"
10812256|NCT00427193|BG002|Baseline|Total|Total of all reporting groups
10812257|NCT00427193|FG000|Participant Flow|Caloric Restriction (CR)|"25% caloric restriction~Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months"
10812258|NCT00427193|FG001|Participant Flow|Ad Libitum|"Ad libitum energy intake~Control: Participants continue their current diet for 24 months"
10812259|NCT00427193|OG000|Outcome|Caloric Restriction (CR)|"25% caloric restriction~Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months"
10812260|NCT00427193|OG001|Outcome|Ad Libitum|"Ad libitum energy intake~Control: Participants continue their current diet for 24 months"
10812261|NCT00427193|OG000|Outcome|Prescribed 25% Caloric Restriction|2 years of prescribed 25% Caloric Restriction
10812262|NCT00427193|OG001|Outcome|Ad Libitum|Usual caloric intake
10812263|NCT00427193|EG000|Reported Event|Caloric Restriction (CR)|"25% caloric restriction~Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months"
10812264|NCT00427193|EG001|Reported Event|Ad Libitum|"Ad libitum energy intake~Control: Participants continue their current diet for 24 months"
11205972|NCT02233478|BG000|Baseline|All Study Participants|Participants took pomegranate juice (PJ, 236.5 mL or 8 fl.oz) alone, or PJ (236.5 mL) mixed with 20 g of soy protein, or PJ (236.5 mL) mixed with 20 g of soybean flour in random order.
11205973|NCT02233478|FG000|Participant Flow|PJ First, Then PJ With Soybean Flour, Then PJ With Soy Protein|Participants consumed PJ alone, then PJ+ soybean flour, then PJ + soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
10812265|NCT00148733|BG000|Baseline|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812266|NCT00148733|BG001|Baseline|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812267|NCT00148733|BG002|Baseline|Total|Total of all reporting groups
10812268|NCT00148733|FG000|Participant Flow|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812269|NCT00148733|FG001|Participant Flow|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812270|NCT00148733|OG000|Outcome|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812271|NCT00148733|OG001|Outcome|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812272|NCT00148733|EG000|Reported Event|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812273|NCT00148733|EG001|Reported Event|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
10812274|NCT00142584|BG000|Baseline|1-NEB|"Nebivolol~Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks."
11205974|NCT02233478|FG001|Participant Flow|PJ First, Then PJ With Soy Protein, Then PJ With Soybean Flour|Participants consumed PJ alone, then PJ+ soy protein, then PJ + soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
10812275|NCT00142584|BG001|Baseline|2-MET|"Metoprolol~Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks."
10812276|NCT00142584|BG002|Baseline|Total|Total of all reporting groups
10812277|NCT00142584|FG000|Participant Flow|1-NEB|"Nebivolol~Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks."
10812278|NCT00142584|FG001|Participant Flow|2-MET|"Metoprolol~Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks."
10812279|NCT00142584|OG000|Outcome|1-NEB|"Nebivolol (NEB)~Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks."
10812280|NCT00142584|OG001|Outcome|2-MET|"Metoprolol (MET)~Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks."
10812281|NCT00142584|OG000|Outcome|1-NEB|"Nebivolol~Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks."
10812282|NCT00142584|OG001|Outcome|2-MET|"Metoprolol~Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks."
10812283|NCT00142584|EG000|Reported Event|1-NEB|"Nebivolol~Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks."
10812284|NCT00142584|EG001|Reported Event|2-MET|"Metoprolol~Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks."
10821711|NCT00070317|FG000|Participant Flow|Radionuclide and Isosulfan Blue Injection|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
10821712|NCT00070317|OG000|Outcome|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
10847651|NCT00284557|BG000|Baseline|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
11205975|NCT02233478|FG002|Participant Flow|PJ With Soybean Flour First, Then PJ, Then PJ With Soy Protein|Participants consumed PJ+soybean flour, then PJ alone, then PJ+soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
11205976|NCT02233478|FG003|Participant Flow|PJ With Soybean Flour First, Then PJ With Soy Protein, Then PJ|Participants consumed PJ+soybean flour, then PJ+soy protein, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
10812285|NCT04753710|BG000|Baseline|Chloroprocaine|"Chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812286|NCT04753710|BG001|Baseline|Placebo|"Vehicle for chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812287|NCT04753710|BG002|Baseline|Total|Total of all reporting groups
10812288|NCT04753710|FG000|Participant Flow|Chloroprocaine|"Chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812289|NCT04753710|FG001|Participant Flow|Placebo|"Vehicle for chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812290|NCT04753710|OG000|Outcome|Chloroprocaine|"Chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812291|NCT04753710|OG001|Outcome|Placebo|"Vehicle for chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812292|NCT04753710|EG000|Reported Event|Chloroprocaine|"Chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812293|NCT04753710|EG001|Reported Event|Placebo|"Vehicle for chloroprocaine 3% ocular gel~Ocular gel: Instillation"
10812294|NCT04570605|BG000|Baseline|Standard Urotherapy|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812295|NCT04570605|BG001|Baseline|Standard Urotherapy + PTENS|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.~parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812296|NCT04570605|BG002|Baseline|Total|Total of all reporting groups
10812297|NCT04570605|FG000|Participant Flow|Standard Urotherapy|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
11205977|NCT02233478|FG004|Participant Flow|PJ With Soy Protein First, Then PJ With Soybean Flour, Then PJ|Participants consumed PJ+soy protein, then PJ+soybean flour, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
10812298|NCT04570605|FG001|Participant Flow|Standard Urotherapy + PTENS|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.~parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812299|NCT04570605|OG000|Outcome|Standard Urotherapy|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812300|NCT04570605|OG001|Outcome|Standard Urotherapy + PTENS|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.~parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812301|NCT04570605|EG000|Reported Event|Standard Urotherapy|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812302|NCT04570605|EG001|Reported Event|Standard Urotherapy + PTENS|"Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.~parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.~Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care."
10812303|NCT04551898|BG000|Baseline|Placebo|Single intravenous infusion of placebo solution administered over 30 to 90 minutes
10812304|NCT04551898|BG001|Baseline|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
10812305|NCT04551898|BG002|Baseline|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
10812306|NCT04551898|BG003|Baseline|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
10812307|NCT04551898|BG004|Baseline|Total|Total of all reporting groups
11205978|NCT02233478|FG005|Participant Flow|PJ With Soy Protein First, Then PJ, Then PJ With Soybean Flour|Participants consumed PJ+soy protein, then PJ alone, then PJ+soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
11205979|NCT02233478|OG000|Outcome|All Study Participants Consuming PJ|Participants consumed PJ (236.5 mL) only
10812308|NCT04551898|FG000|Participant Flow|Placebo|Single intravenous infusion of placebo solution administered over 30 to 90 minutes
10812309|NCT04551898|FG001|Participant Flow|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutes
10812310|NCT04551898|FG002|Participant Flow|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
10812311|NCT04551898|FG003|Participant Flow|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
10812312|NCT04551898|OG000|Outcome|Placebo|Single intravenous infusion of placebo solution administered over 30 to 90 minutes
10812313|NCT04551898|OG001|Outcome|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
10812314|NCT04551898|OG002|Outcome|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
10812315|NCT04551898|OG003|Outcome|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
10812316|NCT04551898|OG001|Outcome|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
10812317|NCT04551898|OG002|Outcome|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
10812318|NCT04551898|OG003|Outcome|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
10812319|NCT04551898|OG000|Outcome|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
10812320|NCT04551898|OG001|Outcome|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
10812321|NCT04551898|OG002|Outcome|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
10812322|NCT04551898|EG000|Reported Event|Placebo|Single intravenous infusion of placebo solution administered over 30 to 90 minutes
10812323|NCT04551898|EG001|Reported Event|BGB-DXP593 5 mg/kg|Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
10812324|NCT04551898|EG002|Reported Event|BGB-DXP593 15 mg/kg|Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
10812325|NCT04551898|EG003|Reported Event|BGB-DXP593 30 mg/kg|Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
10812326|NCT04402866|BG000|Baseline|Part 1: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812327|NCT04402866|BG001|Baseline|Part 1: TD-0903 - 1 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg. Participants were administered a 2 mg loading dose as the total dose on Day 1.
10812328|NCT04402866|BG002|Baseline|Part 1: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
10812329|NCT04402866|BG003|Baseline|Part 1: TD-0903 - 10 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
10812330|NCT04402866|BG004|Baseline|Part 2: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812331|NCT04402866|BG005|Baseline|Part 2: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
10812332|NCT04402866|BG006|Baseline|Total|Total of all reporting groups
10812333|NCT04402866|FG000|Participant Flow|Part 1: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812334|NCT04402866|FG001|Participant Flow|Part 1: TD-0903 - 1 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg. Participants were administered a 2 mg loading dose as the total dose on Day 1.
10812335|NCT04402866|FG002|Participant Flow|Part 1: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
10812336|NCT04402866|FG003|Participant Flow|Part 1: TD-0903 - 10 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
10812337|NCT04402866|FG004|Participant Flow|Part 2: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812338|NCT04402866|FG005|Participant Flow|Part 2: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
10812339|NCT04402866|OG000|Outcome|Part 2: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812340|NCT04402866|OG001|Outcome|Part 2: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
10812341|NCT04402866|EG000|Reported Event|Part 1: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812342|NCT04402866|EG001|Reported Event|Part 1: TD-0903 - 1 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg.
10812343|NCT04402866|EG002|Reported Event|Part 1: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg.
10812344|NCT04402866|EG003|Reported Event|Part 1: TD-0903 - 10 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
10812345|NCT04402866|EG004|Reported Event|Part 2: Matching Placebo|Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
10812346|NCT04402866|EG005|Reported Event|Part 2: TD-0903 - 3 mg|TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system. Participants were administered the recommended dose of 3 mg based on the data from Part 1.
11205980|NCT02233478|OG001|Outcome|All Study Participants Comsuming PJ With Soy Protein|Participants consumed PJ (236.5 mL) mixed with soy protein isolate (20 g)
11205981|NCT02233478|OG002|Outcome|All Study Participants Comsuming PJ With Soybean Flour|Participants consumed PJ (236.5 mL) with soybean flour protein (20 g)
11205982|NCT02233478|EG000|Reported Event|Study Participants Consuming PJ Alone|All participants consumed PJ (236.5 mL or 8 fl.oz) alone
11205983|NCT02233478|EG001|Reported Event|Study Participants Consuming PJ With Soy Protein|All participants consumed PJ (236.5 mL) mixed with 20 g of soy protein
11205984|NCT02233478|EG002|Reported Event|Study Participants Consuming PJ With Soybean Flour|All participants consumed PJ (236.5 mL) mixed with 20 g of soybean flour
11205985|NCT02233517|BG000|Baseline|Cognitive Behavioral Therapy|"Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol. Each session lasts 90 minutes. The first session orients participants to the structure and philosophy of the program, provides a historical overview of PTSD, and introduces the concept of the survival mode of functioning. The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members. CBT-A provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning."
10812347|NCT04327388|BG000|Baseline|Sarilumab 200 mg|"Sarilumab 200 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812348|NCT04327388|BG001|Baseline|Sarilumab 400 mg|"Sarilumab 400 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 400 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812349|NCT04327388|BG002|Baseline|Placebo|"Placebo (for sarilumab), single dose of IV injection on Day 1. Participants could receive a second dose of placebo (for sarilumab) 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812350|NCT04327388|BG003|Baseline|Total|Total of all reporting groups
10812351|NCT04327388|FG000|Participant Flow|Sarilumab 200 mg|"Sarilumab 200 mg, single dose of intravenous (IV) injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in fraction of inspired oxygen (FiO2) requirement or~Required vasopressors, extracorporeal membrane oxygenation (ECMO) or development of multi-organ dysfunction."
10812352|NCT04327388|FG001|Participant Flow|Sarilumab 400 mg|"Sarilumab 400 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 400 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812353|NCT04327388|FG002|Participant Flow|Placebo|"Placebo (for sarilumab), single dose of IV injection on Day 1. Participants could receive a second dose of placebo (for sarilumab) 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812354|NCT04327388|OG000|Outcome|Sarilumab 200 mg|"Sarilumab 200 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812355|NCT04327388|OG001|Outcome|Sarilumab 400 mg|"Sarilumab 400 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 400 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812356|NCT04327388|OG002|Outcome|Placebo|"Placebo (for sarilumab), single dose of IV injection on Day 1. Participants could receive a second dose of placebo (for sarilumab) 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812357|NCT04327388|EG000|Reported Event|Sarilumab 200 mg|"Sarilumab 200 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10812358|NCT04327388|EG001|Reported Event|Sarilumab 400 mg|"Sarilumab 400 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 400 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10847652|NCT00284557|BG001|Baseline|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
10812359|NCT04327388|EG002|Reported Event|Placebo|"Placebo (for sarilumab), single dose of IV injection on Day 1. Participants could receive a second dose of placebo (for sarilumab) 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]):~Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and~Increase/recurrence of fever or~Increase/no change in FiO2 requirement or~Required vasopressors, ECMO or development of multi-organ dysfunction."
10821713|NCT00070317|EG000|Reported Event|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
10821714|NCT00070941|BG000|Baseline|SAM-e|oral SAM-e, 1200mg or 2400 mg
10821715|NCT00070941|BG001|Baseline|Escitalopram|oral Escitalopram 10mg or 20m
10821716|NCT00070941|BG002|Baseline|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
10821717|NCT00070941|BG003|Baseline|Total|Total of all reporting groups
10821718|NCT00070941|FG000|Participant Flow|SAM-e|SAM-e, 1200mg or 2400 mg
10821719|NCT00070941|FG001|Participant Flow|Escitalopram|oral Escitalopram 10mg or 20m
11215444|NCT02299336|OG000|Outcome|PRN (Pro re Nata)|"2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks~Aflibercept: pro re nata (PRN)~Focal Laser: Focal laser administered based on pre-specified criteria"
11215445|NCT02299336|EG000|Reported Event|PRN (Pro re Nata)|"2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks~Aflibercept: pro re nata (PRN)~Focal Laser: Focal laser administered based on pre-specified criteria"
10821720|NCT00070941|FG002|Participant Flow|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
10821721|NCT00070941|OG000|Outcome|SAM-e|SAM-e, 1200mg or 2400 mg
10821722|NCT00070941|OG001|Outcome|Escitalopram|oral Escitalopram 10mg or 20m
10821723|NCT00070941|OG002|Outcome|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
10821724|NCT00070941|EG000|Reported Event|SAM-e|Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
10821725|NCT00070941|EG001|Reported Event|Oral Escitalopram|Group B/Forty patients receiving oral Escitalopram 10mg or 20m
10821726|NCT00070941|EG002|Reported Event|Placebo|Group C/Twenty patients receiving oral placebo Escitalopram an
10821727|NCT00071006|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
10821728|NCT00071006|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
10821729|NCT00071006|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
10821730|NCT00071006|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
10821731|NCT00071032|BG000|Baseline|Liberal (10 g/dL) Transfusion Strategy|"Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.~Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization."
10821732|NCT00071032|BG001|Baseline|Restrictive Strategy|"Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.~Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL."
10821733|NCT00071032|BG002|Baseline|Total|Total of all reporting groups
10821734|NCT00071032|FG000|Participant Flow|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
10821735|NCT00071032|FG001|Participant Flow|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
10821736|NCT00071032|OG000|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
10821737|NCT00071032|OG001|Outcome|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
10821738|NCT00071032|OG001|Outcome|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
10821739|NCT00071032|EG000|Reported Event|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL
10821740|NCT00071032|EG001|Reported Event|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
10847653|NCT00284557|BG002|Baseline|Total|Total of all reporting groups
10812360|NCT03860259|BG000|Baseline|Auriculotherapy Without Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812361|NCT03860259|BG001|Baseline|Auriculotherapy With Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812362|NCT03860259|BG002|Baseline|Total|Total of all reporting groups
10812363|NCT03860259|FG000|Participant Flow|Auriculotherapy Without Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
11215446|NCT02299349|BG000|Baseline|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
10812364|NCT03860259|FG001|Participant Flow|Auriculotherapy With Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812365|NCT03860259|OG000|Outcome|Auriculotherapy Without Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812366|NCT03860259|OG001|Outcome|Auriculotherapy With Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812367|NCT03860259|EG000|Reported Event|Auriculotherapy Without Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812368|NCT03860259|EG001|Reported Event|Auriculotherapy With Nitrogen Gas|"Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.~Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy"
10812369|NCT03767634|BG000|Baseline|Neonatal Population (Project A)|Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England and Wales).
10812370|NCT03767634|BG001|Baseline|No PN Use (Project B)|All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.
10812371|NCT03767634|BG002|Baseline|PN Use (Project B)|"All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.~Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support."
10812372|NCT03767634|BG003|Baseline|Total|Total of all reporting groups
10812373|NCT03767634|FG000|Participant Flow|Neonatal Population (Project A)|Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England and Wales).
10812374|NCT03767634|FG001|Participant Flow|No PN Use (Project B)|All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.
10812375|NCT03767634|FG002|Participant Flow|PN Use (Project B)|"All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.~Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support."
10812376|NCT03767634|OG000|Outcome|Neonatal Population (Project A)|Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales).
10812377|NCT03767634|OG000|Outcome|No PN Use (Project B)|All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.
10812378|NCT03767634|OG001|Outcome|PN Use (Project B)|"All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.~Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support."
10812379|NCT03767634|OG001|Outcome|PN Use (Project B)|"All neonates born between 30 and 33 weeks postmenstrual age in England and Wales admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.~Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support."
10812380|NCT03767634|EG000|Reported Event|Neonatal Population (Project A)|Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England and Wales).
10812381|NCT03767634|EG001|Reported Event|No PN Use (Project B)|All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.
10812382|NCT03767634|EG002|Reported Event|PN Use (Project B)|"All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.~Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support."
10821741|NCT00071058|BG000|Baseline|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
10821742|NCT00071058|FG000|Participant Flow|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
10821743|NCT00071058|OG000|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
10821744|NCT00071058|OG000|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
10821745|NCT00071058|EG000|Reported Event|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
10821746|NCT00071110|BG000|Baseline|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
10821747|NCT00071110|BG001|Baseline|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
10821748|NCT00071110|BG002|Baseline|Total|Total of all reporting groups
10821749|NCT00071110|FG000|Participant Flow|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
10821750|NCT00071110|FG001|Participant Flow|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
10821751|NCT00071110|OG000|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
10821752|NCT00071110|OG001|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
10821753|NCT00071110|EG000|Reported Event|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
10821754|NCT00071110|EG001|Reported Event|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
10821755|NCT00071396|BG000|Baseline|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
10821756|NCT00071396|FG000|Participant Flow|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
10821757|NCT00071396|OG000|Outcome|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
10821758|NCT00071396|EG000|Reported Event|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
10821759|NCT00071487|BG000|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10812383|NCT03446573|BG000|Baseline|DTG+3TC FDC|Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
10812384|NCT03446573|BG001|Baseline|TAF-based Regimen|"Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the TAF-based regimen arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under TDF-based regimen for Safety because the safety profiles of TDF and TAF differ."
10812385|NCT03446573|BG002|Baseline|Total|Total of all reporting groups
10812386|NCT03446573|FG000|Participant Flow|DTG+3TC FDC|Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
10812387|NCT03446573|FG001|Participant Flow|TAF-based Regimen|"Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the TAF-based regimen arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under TDF-based regimen for Safety because the safety profiles of TDF and TAF differ."
10812388|NCT03446573|OG000|Outcome|DTG+3TC FDC|Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
10812389|NCT03446573|OG001|Outcome|TAF-based Regimen|"Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the TAF-based regimen arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under TDF-based regimen for Safety because the safety profiles of TDF and TAF differ."
10812390|NCT03446573|OG000|Outcome|Randomized to TBR But Received TDF-based Regimen|Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36)
10812391|NCT03446573|OG000|Outcome|Randomized to TBR But Received TDF-based Regimen|Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
10812392|NCT03446573|EG000|Reported Event|DTG + 3TC|Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.
10812393|NCT03446573|EG001|Reported Event|TAF Based Regimen|Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks.
10812394|NCT03446573|EG002|Reported Event|Randomized to TBR But Received TDF-based Regimen|Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
10812395|NCT03388138|BG000|Baseline|Etafilcon A With Ketotifen|Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study.
10812396|NCT03388138|BG001|Baseline|Etafilcon A|Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study.
10812397|NCT03388138|BG002|Baseline|Total|Total of all reporting groups
10812398|NCT03388138|FG000|Participant Flow|Etafilcon A With Ketotifen|Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study.
10812399|NCT03388138|FG001|Participant Flow|Etafilcon A|Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study.
10812400|NCT03388138|OG000|Outcome|Etafilcon A With Ketotifen|Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.
10812401|NCT03388138|OG001|Outcome|Etafilcon A|Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
10812402|NCT03388138|EG000|Reported Event|Etafilcon A With Ketotifen|Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.
10812403|NCT03388138|EG001|Reported Event|Etafilcon A|Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
10812404|NCT03067610|BG000|Baseline|Radiation Therapy|"Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)~Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.~chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion"
10812405|NCT03067610|FG000|Participant Flow|Radiation Therapy|"Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). There was only one study arm. The radiation field and dose are the same with or without chemotherapy. The intent is to assess the effects of radiation therapy, regardless of chemotherapy treatment.~Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.~chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion"
10821760|NCT00071487|BG001|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10812406|NCT03067610|OG000|Outcome|Radiation Therapy|"Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)~Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.~chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion"
10812407|NCT03067610|OG000|Outcome|Total Cohort Baseline|"Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)~Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.~chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion"
10812408|NCT03067610|OG001|Outcome|Total Cohort 3 Month|Total cohort
10812409|NCT03067610|OG002|Outcome|Total Cohort 6 Month|Total cohort
10812410|NCT03067610|OG003|Outcome|Total Cohort 12 Month|Total cohort
10812411|NCT03067610|EG000|Reported Event|Radiation Therapy|"Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)~Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.~chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion"
10812412|NCT03027609|BG000|Baseline|AR-105|"One intravenous infusion of AR-105 20mg/'kg~AR-105: monoclonal antibody"
10812413|NCT03027609|BG001|Baseline|Control|"Matching placebo~placebo: matching placebo"
10812414|NCT03027609|BG002|Baseline|Total|Total of all reporting groups
10812415|NCT03027609|FG000|Participant Flow|AR-105|"One intravenous infusion of AR-105 20mg/'kg~AR-105: monoclonal antibody"
11215447|NCT02299349|BG001|Baseline|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
10812416|NCT03027609|FG001|Participant Flow|Control|"Matching placebo~placebo: matching placebo"
10812417|NCT03027609|OG000|Outcome|AR-105|"One intravenous infusion of AR-105 20mg/'kg~AR-105: monoclonal antibody"
10812418|NCT03027609|OG001|Outcome|Control|"Matching placebo~placebo: matching placebo"
10812419|NCT03027609|OG000|Outcome|Subset AR-105 Study1|"Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to~appropriate clinical Severity~inadequate antibiotic regimen and~lower 3rd quartile of level of CRP"
10812420|NCT03027609|OG001|Outcome|Subset Placebo Study1|"Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to~appropriate clinical Severity~inadequate antibiotic regimen and~lower 3rd quartile of level of CRP"
10812421|NCT03027609|OG000|Outcome|Subset AR-105 Study2|"Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to~appropriate clinical Severity~inadequate antibiotic regimen and~lower 3rd quartile of level of CRP"
10812422|NCT03027609|OG001|Outcome|Subset Placebo Study2|"Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to~appropriate clinical Severity~inadequate antibiotic regimen and~lower 3rd quartile of level of CRP"
10812423|NCT03027609|EG000|Reported Event|AR-105|"One intravenous infusion of AR-105 20mg/'kg~AR-105: monoclonal antibody"
10812424|NCT03027609|EG001|Reported Event|Control|"Matching placebo~placebo: matching placebo"
10812425|NCT02993107|BG000|Baseline|Group 1 (Placebo Crossovers)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks)
10812426|NCT02993107|BG001|Baseline|Group 2: Cohort 1 (Active Rollovers)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
10812427|NCT02993107|BG002|Baseline|Group 2: Cohort 2 (Active Rollovers)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
10812428|NCT02993107|BG003|Baseline|Group 2: Cohort 3A (Active Rollovers)|Received 300 mg/day peanut protein for 56 weeks
10812429|NCT02993107|BG004|Baseline|Group 2: Cohort 3B (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
10812430|NCT02993107|BG005|Baseline|Group 2: Cohort 3C (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)
11215448|NCT02299349|BG002|Baseline|Total|Total of all reporting groups
11215449|NCT02299349|FG000|Participant Flow|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
10812431|NCT02993107|BG006|Baseline|Total|Total of all reporting groups
11205986|NCT02233517|BG001|Baseline|Present Centered Therapy|"Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now. Previous large-scale randomized clinical trials of Veterans with PTSD have found reduced PTSD symptoms in the PCT comparison condition (Schnurr et al., 2003), and a survey of practice patterns within the VA suggests that similar present-focused approaches are routinely employed by VA mental health providers (Rosen et al., 2004). Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions."
11205987|NCT02233517|BG002|Baseline|Total|Total of all reporting groups
11215450|NCT02299349|FG001|Participant Flow|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
10812432|NCT02993107|FG000|Participant Flow|Group 1 (Placebo Crossovers)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
10812433|NCT02993107|FG001|Participant Flow|Group 2: Cohort 1 (Active Rollovers)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
10812434|NCT02993107|FG002|Participant Flow|Group 2: Cohort 2 (Active Rollovers)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
10812435|NCT02993107|FG003|Participant Flow|Group 2: Cohort 3A (Active Rollovers)|Received 300 mg/day peanut protein for 56 weeks
10812436|NCT02993107|FG004|Participant Flow|Group 2: Cohort 3B (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
10812437|NCT02993107|FG005|Participant Flow|Group 2: Cohort 3C (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)
10812438|NCT02993107|OG000|Outcome|Group 1 (Overall)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
10812439|NCT02993107|OG001|Outcome|Group 2: Cohort 1 (QD)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
10812440|NCT02993107|OG002|Outcome|Group 2: Cohort 2 (Overall)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
10812441|NCT02993107|OG003|Outcome|Group 2: Cohort 3A (QD)|Received 300 mg/day peanut protein for 56 weeks
10812442|NCT02993107|OG004|Outcome|Group 2: Cohort 3B (Overall)|Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
10812443|NCT02993107|OG005|Outcome|Group 2: Cohort 3C (Overall)|Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks)
10812444|NCT02993107|OG000|Outcome|Group 1 (Placebo Crossovers)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks) (age 4-17).
10812445|NCT02993107|OG001|Outcome|Group 2: Cohort 1 (Active Rollovers)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
10812446|NCT02993107|OG002|Outcome|Group 2: Cohort 2 (Active Rollovers)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
10812447|NCT02993107|OG003|Outcome|Group 2: Cohort 3A (Active Rollovers)|Received 300 mg/day peanut protein for 56 weeks
10812448|NCT02993107|OG004|Outcome|Group 2: Cohort 3B (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
10812449|NCT02993107|OG005|Outcome|Group 2: Cohort 3C (Active Rollovers)|Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)
10812450|NCT02993107|EG000|Reported Event|Group 1 (Age 4-17 Overall)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
10812451|NCT02993107|EG001|Reported Event|Group 2: Cohort 1 (Age 4-17 QD)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.
10812452|NCT02993107|EG002|Reported Event|Group 2: Cohort 2 (Age 4-17 Overall)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.
10812453|NCT02993107|EG003|Reported Event|Group 2: Cohort 3A (Age 4-17 QD)|Received 300 mg/day peanut protein for 56 weeks.
10812454|NCT02993107|EG004|Reported Event|Group 2: Cohort 3B (Age 4-17 Overall)|Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).
10812455|NCT02993107|EG005|Reported Event|Group 2: Cohort 3C (Age 4-17 Overall)|Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).
10812456|NCT02993107|EG006|Reported Event|Group 1 (Age 18-55 Overall)|Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
10812457|NCT02993107|EG007|Reported Event|Group 2: Cohort 1 (Age 18-55 QD)|Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.
10812458|NCT02993107|EG008|Reported Event|Group 2: Cohort 2 (Age 18-55 Overall)|Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.
10812459|NCT02993107|EG009|Reported Event|Group 2: Cohort 3A (Age 18-55 QD)|Received 300 mg/day peanut protein for 56 weeks.
10812460|NCT02993107|EG010|Reported Event|Group 2: Cohort 3B (Age 18-55 Overall)|Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).
10812461|NCT02993107|EG011|Reported Event|Group 2: Cohort 3C (Age 18-55 Overall)|Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).
10812462|NCT02981082|BG000|Baseline|Dimethyl Fumarate (DMF)|"Once daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days, following a titration schedule reaching a minimum of 120mg DMF twice daily, maximum 240mg twice daily, by the start of week 8. Subjects will be dosed for 24 weeks.~Dimethyl Fumarate (DMF): Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis."
10812463|NCT02981082|BG001|Baseline|Placebo|"Twice daily oral doses of placebo for 12 weeks.~Placebo Oral Tablet: Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)"
10812464|NCT02981082|BG002|Baseline|Total|Total of all reporting groups
10812465|NCT02981082|FG000|Participant Flow|Dimethyl Fumarate (DMF)|"Once daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days, following a titration schedule reaching a minimum of 120mg DMF twice daily, maximum 240mg twice daily, by the start of week 8. Subjects will be dosed for 24 weeks.~Dimethyl Fumarate (DMF): Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis."
10812466|NCT02981082|FG001|Participant Flow|Placebo|"Twice daily oral doses of placebo for 12 weeks.~Placebo Oral Tablet: Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)"
10812467|NCT02981082|OG000|Outcome|Dimethyl Fumarate (DMF)|"Once daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days, following a titration schedule reaching a minimum of 120mg DMF twice daily, maximum 240mg twice daily, by the start of week 8. Subjects will be dosed for 24 weeks.~Dimethyl Fumarate (DMF): Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis."
10812468|NCT02981082|OG001|Outcome|Placebo|"Twice daily oral doses of placebo for 12 weeks.~Placebo Oral Tablet: Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)"
10812469|NCT02981082|EG000|Reported Event|Dimethyl Fumarate (DMF)|"Once daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days, following a titration schedule reaching a minimum of 120mg DMF twice daily, maximum 240mg twice daily, by the start of week 8. Subjects will be dosed for 24 weeks.~Dimethyl Fumarate (DMF): Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis."
10812470|NCT02981082|EG001|Reported Event|Placebo|"Twice daily oral doses of placebo for 12 weeks.~Placebo Oral Tablet: Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)"
10812471|NCT02924129|BG000|Baseline|Evoke SCS With Feedback|"closed-loop/automatic stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812472|NCT02924129|BG001|Baseline|Evoke SCS With Conventional|"open-loop/manual stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812473|NCT02924129|BG002|Baseline|Total|Total of all reporting groups
10812474|NCT02924129|FG000|Participant Flow|Evoke SCS With Feedback|"closed-loop/automatic stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812475|NCT02924129|FG001|Participant Flow|Evoke SCS With Conventional|"open-loop/manual stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812476|NCT02924129|OG000|Outcome|Evoke SCS With Feedback|"closed-loop/automatic stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812477|NCT02924129|OG001|Outcome|Evoke SCS With Conventional|"open-loop/manual stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812478|NCT02924129|EG000|Reported Event|Evoke SCS With Feedback|"closed-loop/automatic stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812479|NCT02924129|EG001|Reported Event|Evoke SCS With Conventional|"open-loop/manual stimulation~Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs)."
10812480|NCT02741700|BG000|Baseline|Gout Storytelling Video|"Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812481|NCT02741700|BG001|Baseline|Video About Management of Another Chronic Condition|"Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812482|NCT02741700|BG002|Baseline|Total|Total of all reporting groups
10812483|NCT02741700|FG000|Participant Flow|Gout Storytelling Video|"Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812484|NCT02741700|FG001|Participant Flow|Video About Management of Another Chronic Condition|"Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812485|NCT02741700|OG000|Outcome|Gout Storytelling Video|"Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812486|NCT02741700|OG001|Outcome|Video About Management of Another Chronic Condition|"Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812487|NCT02741700|EG000|Reported Event|Gout Storytelling Video|"Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10821761|NCT00071487|BG002|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10812488|NCT02741700|EG001|Reported Event|Video About Management of Another Chronic Condition|"Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.~Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout."
10812489|NCT02635776|BG000|Baseline|AR101|"AR101 drug product provided in two presentations. These were peanut protein in pull-apart capsules or sachets.~Pull-apart capsules contained 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets contained 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
10812490|NCT02635776|BG001|Baseline|Placebo|"A Placebo matching the AR101 drug product was supplied in two presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
10812491|NCT02635776|BG002|Baseline|Total|Total of all reporting groups
10812492|NCT02635776|FG000|Participant Flow|AR101|"AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
10812493|NCT02635776|FG001|Participant Flow|Placebo|"A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
10812494|NCT02635776|OG000|Outcome|AR101|"Study product provided as peanut protein in pull-apart capsules or sachets.~AR101 powder provided in capsules & sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol"
11205988|NCT02233517|FG000|Participant Flow|Cognitive Behavioral Therapy|"Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol Each session lasts 90 minutes.The first session orients participants to the program, provides an overview of PTSD, and introduces the concept of the survival mode of functioning. The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members. Cognitive Behavioral Therapy: CBT-A provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning."
10812495|NCT02635776|OG001|Outcome|Placebo|"Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients~Placebo powder provided in capsules & sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol"
10812496|NCT02635776|EG000|Reported Event|AR101 (Age 4-17)|"Study product provided as peanut protein in pull-apart capsules or sachets.~AR101 powder provided in capsules & sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol."
10812497|NCT02635776|EG001|Reported Event|Placebo (Age 4-17)|"Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients.~Placebo powder provided in capsules & sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol."
11215451|NCT02299349|OG000|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
10812498|NCT02635776|EG002|Reported Event|AR101 (Age 18-55)|"Study product provided as peanut protein in pull-apart capsules or sachets.~AR101 powder provided in capsules & sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol."
10812499|NCT02635776|EG003|Reported Event|Placebo (Age 18-55)|"Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients.~Placebo powder provided in capsules & sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol."
10812500|NCT02609724|BG000|Baseline|Fluoroscopy-guided MLD|"Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Fluoroscopy-guided MLD: Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors"
10821762|NCT00071487|BG003|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10821763|NCT00071487|BG004|Baseline|Total|Total of all reporting groups
10821764|NCT00071487|FG000|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
11215452|NCT02299349|OG001|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
10812501|NCT02609724|BG001|Baseline|Traditional MLD|"Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Traditional MLD: Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin."
10812502|NCT02609724|BG002|Baseline|Placebo MLD|"Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Placebo MLD: During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly."
10812503|NCT02609724|BG003|Baseline|Total|Total of all reporting groups
10812504|NCT02609724|FG000|Participant Flow|Fluoroscopy-guided MLD|"Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Fluoroscopy-guided MLD: Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors"
10812505|NCT02609724|FG001|Participant Flow|Traditional MLD|"Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Traditional MLD: Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin."
10812506|NCT02609724|FG002|Participant Flow|Placebo MLD|"Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Placebo MLD: During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly."
10812507|NCT02609724|OG000|Outcome|Fluoroscopy-guided MLD|"Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Fluoroscopy-guided MLD: Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors"
10847654|NCT00284557|FG000|Participant Flow|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
10812508|NCT02609724|OG001|Outcome|Traditional MLD|"Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Traditional MLD: Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin."
10812509|NCT02609724|OG002|Outcome|Placebo MLD|"Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Placebo MLD: During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly."
10812510|NCT02609724|EG000|Reported Event|Fluoroscopy-guided MLD|"Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Fluoroscopy-guided MLD: Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors"
10812511|NCT02609724|EG001|Reported Event|Traditional MLD|"Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Traditional MLD: Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin."
10812512|NCT02609724|EG002|Reported Event|Placebo MLD|"Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up~Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material~Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.~Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment~Placebo MLD: During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly."
10812513|NCT02359994|BG000|Baseline|PerClot|Participants received up to two 5 gram bellows during index procedure.
10812514|NCT02359994|BG001|Baseline|Arista|Active Control. Participants received up to two 5 gram bellows during index procedure.
10812515|NCT02359994|BG002|Baseline|Total|Total of all reporting groups
10812516|NCT02359994|FG000|Participant Flow|PerClot|Participants received up to two 5 gram bellows during study procedure.
10812517|NCT02359994|FG001|Participant Flow|Arista|Active Control. Participants received up to two 5 gram bellows during study procedure.
10812518|NCT02359994|OG000|Outcome|PerClot|Participants received up to two 5 gram bellows during index procedure.
10812519|NCT02359994|OG001|Outcome|Arista|Active Control. Participants received up to two 5 gram bellows during index procedure.
10812520|NCT02359994|EG000|Reported Event|PerClot|Participants received up to two 5 gram bellows during index procedure.
10812521|NCT02359994|EG001|Reported Event|Arista|Active Control. Participants received up to two 5 gram bellows during index procedure.
10821765|NCT00071487|FG001|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
10812522|NCT02336230|BG000|Baseline|Remestemcel-L 2×10^6 MSCs/kg|Participants were treated with IV remestemcel-L at a dose of 2×10^6 MSCs/kg actual body weight at Screening, twice per week, for each of 4 consecutive weeks (initial therapy) given at least 3 days apart and no more than 5 days apart for any infusion. Eligible participants received an additional once per week infusion, for each of 4 consecutive weeks (continued therapy) of remestemcel-L and twice per week infusions, for each of 4 consecutive weeks (aGVHD flare therapy) of remestemcel-L at the same initial therapy dose of 2×10^6 MSCs/kg actual body weight at Screening.
10812523|NCT02336230|FG000|Participant Flow|Remestemcel-L 2×10^6 MSCs/kg|Participants were treated with intravenous (IV) remestemcel-L at a dose of 2×10^6 mesenchymal stromal cells (MSCs)/kilogram (kg) actual body weight at Screening, twice per week, for each of 4 consecutive weeks (initial therapy) given at least 3 days apart and no more than 5 days apart for any infusion. Eligible participants received an additional once per week infusion, for each of 4 consecutive weeks (continued therapy) of remestemcel-L and twice per week infusions, for each of 4 consecutive weeks (aGVHD flare therapy) of remestemcel-L at the same initial therapy dose of 2×10^6 MSCs/kg actual body weight at Screening.
10812524|NCT02336230|OG000|Outcome|Remestemcel-L 2×10^6 MSCs/kg|Participants were treated with IV remestemcel-L at a dose of 2×10^6 MSCs/kg actual body weight at Screening, twice per week, for each of 4 consecutive weeks (initial therapy) given at least 3 days apart and no more than 5 days apart for any infusion. Eligible participants received an additional once per week infusion, for each of 4 consecutive weeks (continued therapy) of remestemcel-L and twice per week infusions, for each of 4 consecutive weeks (aGVHD flare therapy) of remestemcel-L at the same initial therapy dose of 2×10^6 MSCs/kg actual body weight at Screening.
10812525|NCT02336230|EG000|Reported Event|Remestemcel-L 2×10^6 MSCs/kg|Participants were treated with IV remestemcel-L at a dose of 2×10^6 MSCs/kg actual body weight at Screening, twice per week, for each of 4 consecutive weeks (initial therapy) given at least 3 days apart and no more than 5 days apart for any infusion. Eligible participants received an additional once per week infusion, for each of 4 consecutive weeks (continued therapy) of remestemcel-L and twice per week infusions, for each of 4 consecutive weeks (aGVHD flare therapy) of remestemcel-L at the same initial therapy dose of 2×10^6 MSCs/kg actual body weight at Screening.
10812526|NCT01557751|BG000|Baseline|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
10812527|NCT01557751|FG000|Participant Flow|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
10812528|NCT01557751|OG000|Outcome|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
10812529|NCT01557751|EG000|Reported Event|Total Knee Arthroplasty Subjects Who Are Genotyped|"All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).~Whole blood for genotyping: This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study."
10812530|NCT01363401|BG000|Baseline|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
10812531|NCT01363401|BG001|Baseline|No Treatment|"No treatment with HYNR-CS inj.~Take each 50mg 1 hour before a meal or 2 hours after a meal at least at an interval of 12 hours, 28 weeks(12 weeks of run-in phase plus 16 weeks of treatment phase)"
10812532|NCT01363401|BG002|Baseline|Total|Total of all reporting groups
10812533|NCT01363401|FG000|Participant Flow|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
10812534|NCT01363401|FG001|Participant Flow|No Treatment|No treatment with HYNR-CS inj.
10812535|NCT01363401|OG000|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
10812536|NCT01363401|OG001|Outcome|No Treatment|No treatment with HYNR-CS inj.
10812537|NCT01363401|EG000|Reported Event|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
10812538|NCT01363401|EG001|Reported Event|No Treatment|No treatment with HYNR-CS inj.
10821766|NCT00071487|FG002|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
10821767|NCT00071487|FG003|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
10821768|NCT00071487|OG000|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10821769|NCT00071487|OG001|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10821770|NCT00071487|OG002|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10812539|NCT00961064|BG000|Baseline|Eltrombopag|Eltrombopag (EPAG), a thrombopoietin receptor agonist, was started at 50 mg/day, up to a maximal dose of 150 mg/day, increasing the dose by 25mg every 2 weeks.
10812540|NCT00961064|FG000|Participant Flow|Eltrombopag|Eltrombopag (EPAG), a thrombopoietin receptor agonist, was started at 50 mg/day, up to a maximal dose of 150 mg/day, increasing the dose by 25mg every 2 weeks.
10812541|NCT00961064|OG000|Outcome|Eltrombopag|Eltrombopag (EPAG), a thrombopoietin receptor agonist, was started at 50 mg/day, up to a maximal dose of 150 mg/day, increasing the dose by 25mg every 2 weeks.
10812542|NCT00961064|EG000|Reported Event|Eltrombopag|Eltrombopag (EPAG), a thrombopoietin receptor agonist, was started at 50 mg/day, up to a maximal dose of 150 mg/day, increasing the dose by 25mg every 2 weeks.
10812547|NCT03825393|BG000|Baseline|Fibromiyalgia|100 Fibromyalgia Patient Group
10812548|NCT03825393|BG001|Baseline|Control|100 Control Group
10812549|NCT03825393|BG002|Baseline|Total|Total of all reporting groups
10812550|NCT03825393|FG000|Participant Flow|Fibromiyalgia|100 Fibromyalgia Patient Group
10812551|NCT03825393|FG001|Participant Flow|Control|100 Control Group
10812552|NCT03825393|OG000|Outcome|Fibromyalgia|Fibromyalgia syndrome group
10812553|NCT03825393|OG000|Outcome|Control|Control Group
10812554|NCT03825393|OG001|Outcome|Fibromyalgia|Fibromyalgia syndrome
10812555|NCT03825393|OG000|Outcome|Fibromiyalgia|100 Fibromyalgia Patient Group 100 Control Group
10812556|NCT03825393|EG000|Reported Event|Fibromiyalgia|100 Fibromyalgia Patient Group
10812557|NCT03825393|EG001|Reported Event|Control|100 Control Group
10821771|NCT00071487|OG003|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
10821772|NCT00071487|OG004|Outcome|Open-Label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
10821773|NCT00071487|EG000|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
10821774|NCT00071487|EG001|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
10821775|NCT00071487|EG002|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
10821776|NCT00071487|EG003|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
10821777|NCT00071487|EG004|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
10821778|NCT00071513|BG000|Baseline|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821779|NCT00071513|BG001|Baseline|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821780|NCT00071513|BG002|Baseline|Total|Total of all reporting groups
10821781|NCT00071513|FG000|Participant Flow|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
11215453|NCT02299349|EG000|Reported Event|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
10812558|NCT03813719|BG000|Baseline|All Patients Attending Rapid Access Gynaecology Clinic|Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
10812559|NCT03813719|FG000|Participant Flow|All Patients Attending Rapid Access Gynaecology Clinic|All patients attending Rapid access Gynaecology Clinic for the first time.
10812560|NCT03813719|OG000|Outcome|All Patients Attending Rapid Access Gynaecology Clinic|All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
10812561|NCT03813719|OG000|Outcome|All Patients Attending Rapid Access Gynaecology Clinic|Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
10812562|NCT03813719|OG000|Outcome|All Patients Attending Rapid Access Gynaecology Clinic|All patients attending Rapid access Gynaecology Clinic for the first time.
10812563|NCT03813719|EG000|Reported Event|All Patients Attending Rapid Access Gynaecology Clinic|All patients attending Rapid access Gynaecology Clinic for the first time.
10812564|NCT03798756|BG000|Baseline|Cohort|This was a Cohort, there were no arms. It was an entire group.
10812565|NCT03798756|FG000|Participant Flow|Cohort|Automated check-in
10812566|NCT03798756|OG000|Outcome|Bodily Pain|To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen.
10812567|NCT03798756|OG000|Outcome|Cohort|Automated check-in
10812568|NCT03798756|EG000|Reported Event|Cohort|All those patients checking-in for a pre-booked consultation using an automated check-in screen and answering at least one research question
10821782|NCT00071513|FG001|Participant Flow|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821783|NCT00071513|OG000|Outcome|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821784|NCT00071513|OG001|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821785|NCT00071513|OG000|Outcome|CAST-T/HSTS|"The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST-T/HSTS: Skills training small group."
10821786|NCT00071513|OG001|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~Brief Intervention: Assessment of needs and referral to services as needed."
10821787|NCT00071513|EG000|Reported Event|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
10812569|NCT03790917|BG000|Baseline|ANTEY|"Patients with AF from the PROFILE registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning."
10812570|NCT03790917|FG000|Participant Flow|ANTEY|"Patients with AF from the PROFILE registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning."
10812571|NCT03790917|OG000|Outcome|ANTEY|"Patients with AF from the PROFILE registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning."
10812572|NCT03790917|OG000|Outcome|ANTEY|"Patients with AF from the PROFILE registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning."
11205989|NCT02233517|FG001|Participant Flow|Present Centered Therapy|"Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now. Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions."
11205990|NCT02233517|OG000|Outcome|Cognitive Behavioral Therapy|"Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. Each session lasts 90 minutes. The first session orients participants to the structure and philosophy of the program, provides a historical overview of PTSD, and introduces the concept of the survival mode of functioning (Chemtob et al., 1997). The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members."
11205991|NCT02233517|OG001|Outcome|Present Centered Therapy|"Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now. Previous large-scale randomized clinical trials of Veterans with PTSD have found reduced PTSD symptoms in the PCT comparison condition (Schnurr et al., 2003), and similar present-focused approaches are routinely employed by VA mental health providers (Rosen et al., 2004). Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions."
11205992|NCT02233517|EG000|Reported Event|Cognitive Behavioral Therapy|"Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol Each session lasts 90 minutes.The first session orients participants to the program, provides an overview of PTSD, and introduces the concept of the survival mode of functioning. The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members. Cognitive Behavioral Therapy: CBT-A provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning."
11205993|NCT02233517|EG001|Reported Event|Present Centered Therapy|"Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now. Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions."
11215454|NCT02299349|EG001|Reported Event|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
11215455|NCT02299375|BG000|Baseline|Placebo|Participants with COPD received placebo orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of inhaled corticosteroid (ICS). Salbutamol metered dose inhaler (MDI) was provided as a rescue medication.
10812573|NCT03790917|EG000|Reported Event|ANTEY|"Patients with AF from the PROFILE registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning."
10812574|NCT03790306|BG000|Baseline|THR With HANA Table|Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
10812575|NCT03790306|FG000|Participant Flow|THR With HANA Table|Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
10812576|NCT03790306|OG000|Outcome|THR With HANA Table|Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
10812577|NCT03790306|OG000|Outcome|THR With HANA Table|Patients undergoing Total Hip Replacement (THR) using the Hip And kNee Arthroplasty (HANA) table
10812578|NCT03790306|EG000|Reported Event|THR With HANA Table|Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
10821788|NCT00071513|EG001|Reported Event|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
10821789|NCT00071721|BG000|Baseline|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
10821790|NCT00071721|BG001|Baseline|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
10821791|NCT00071721|BG002|Baseline|Total|Total of all reporting groups
10821792|NCT00071721|FG000|Participant Flow|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
10821793|NCT00071721|FG001|Participant Flow|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
10821794|NCT00071721|OG000|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
10821795|NCT00071721|OG001|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
10821796|NCT00071721|EG000|Reported Event|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
10821797|NCT00071721|EG001|Reported Event|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
10821798|NCT00071760|BG000|Baseline|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
10821799|NCT00071760|FG000|Participant Flow|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
10821800|NCT00071760|OG000|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
10847655|NCT00284557|FG001|Participant Flow|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
10812579|NCT03727373|BG000|Baseline|Patients With Acute or Chronic Pain|Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).
10812580|NCT03727373|FG000|Participant Flow|Patients With Acute or Chronic Pain|Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).
10812581|NCT03727373|OG000|Outcome|Patients With Acute or Chronic Pain|Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).
10812582|NCT03727373|EG000|Reported Event|Patients With Acute or Chronic Pain|Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).
10812583|NCT05017493|BG000|Baseline|Treatment Arm|"Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.~Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care"
10812584|NCT05017493|BG001|Baseline|Control Arm|Patients in the Control arm received the standard of care for Covid19.
10812585|NCT05017493|BG002|Baseline|Total|Total of all reporting groups
10812586|NCT05017493|FG000|Participant Flow|Treatment Arm|"Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.~Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care"
10812587|NCT05017493|FG001|Participant Flow|Control Arm|Patients in the Control arm received the standard of care for Covid19.
10812588|NCT05017493|OG000|Outcome|Treatment Arm|"Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.~Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care"
10812589|NCT05017493|OG001|Outcome|Control Arm|Patients in the Control arm received the standard of care for Covid19.
10812590|NCT05017493|EG000|Reported Event|Treatment Arm|"Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.~Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care"
10812591|NCT05017493|EG001|Reported Event|Control Arm|Patients in the Control arm received the standard of care for Covid19.
10812592|NCT04870138|BG000|Baseline|Mutant FA7527 - LptA|Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812593|NCT04870138|BG001|Baseline|Wild-type FA1090|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812594|NCT04870138|BG002|Baseline|Mixed FA7527/FA1090|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812595|NCT04870138|BG003|Baseline|Total|Total of all reporting groups
10812596|NCT04870138|FG000|Participant Flow|Mutant FA7527 - LptA|"Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain.~Neisseria gonorrhoeae strain FA7527: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation."
10812597|NCT04870138|FG001|Participant Flow|Wild-type FA1090 A25|"Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.~Neisseria gonorrhoeae strain FA1090 A25: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation."
10812598|NCT04870138|FG002|Participant Flow|Mixed FA7527/FA1090 A25|"Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain.~Neisseria gonorrhoeae strains FA7527 and FA1090 A25: 0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation."
10812599|NCT04870138|OG000|Outcome|Mutant FA7527 - LptA|Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812600|NCT04870138|OG001|Outcome|Wild-type FA1090 A25|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812601|NCT04870138|OG000|Outcome|Mixed FA7527/FA1090 A25|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812602|NCT04870138|OG000|Outcome|Mixed FA7527/FA1090 A25|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on patient request, at the onset of symptoms or on the 5th study day after inoculation.
10812603|NCT04870138|OG000|Outcome|Mutant FA7527|Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812604|NCT04870138|OG002|Outcome|Mixed FA7527/FA1090 A25|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
10812605|NCT04870138|EG000|Reported Event|Mutant FA7527|Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain.
10812606|NCT04870138|EG001|Reported Event|Wild-type FA1090 A25|Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
10812607|NCT04870138|EG002|Reported Event|Mixed FA7527/FA1090 A25|Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain.
10821801|NCT00071760|OG001|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
10821802|NCT00071760|OG000|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
10821803|NCT00071760|OG000|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
10821804|NCT00071760|OG001|Outcome|PI-naïve, ART-experienced FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
10821805|NCT00071760|OG002|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
10821806|NCT00071760|OG001|Outcome|ART-experienced, PI-naïve FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
10847278|NCT00282568|BG000|Baseline|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
10812608|NCT04374149|BG000|Baseline|1 - TPE Alone|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy"
10812609|NCT04374149|BG001|Baseline|2 - TPE Plus Ruxolitinib|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days.~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Ruxolitinib: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days."
10812610|NCT04374149|BG002|Baseline|Total|Total of all reporting groups
10812611|NCT04374149|FG000|Participant Flow|1 - TPE Alone|"Therapeutic Plasma Exchange (TPE), five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy"
10812612|NCT04374149|FG001|Participant Flow|2 - TPE Plus Ruxolitinib|"Therapeutic Plasma Exchange (TPE), five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy combined with ruxolitinib 5mg po twice daily (BID) beginning day prior to first TPE and continuing BID for total of 14 days.~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy~Ruxolitinib: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po twice daily (BID) beginning day prior to first TPE and continuing BID for total of 14 days."
10812613|NCT04374149|OG000|Outcome|1 - TPE Alone|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy"
10812614|NCT04374149|OG001|Outcome|2 - TPE Plus Ruxolitinib|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days.~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Ruxolitinib: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days."
10812615|NCT04374149|EG000|Reported Event|1 - TPE Alone|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy"
10812616|NCT04374149|EG001|Reported Event|2 - TPE Plus Ruxolitinib|"TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days.~Therapeutic Plasma Exchange: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy~Ruxolitinib: TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days."
10812617|NCT04348500|BG000|Baseline|Clazakizumab|25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812618|NCT04348500|BG001|Baseline|Placebo|50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812619|NCT04348500|BG002|Baseline|Total|Total of all reporting groups
10812620|NCT04348500|FG000|Participant Flow|Clazakizumab|25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812621|NCT04348500|FG001|Participant Flow|Placebo|50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812622|NCT04348500|OG000|Outcome|Clazakizumab|25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812623|NCT04348500|OG001|Outcome|Placebo|50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812624|NCT04348500|EG000|Reported Event|Clazakizumab|25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812625|NCT04348500|EG001|Reported Event|Placebo|50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
10812626|NCT04347941|BG000|Baseline|Prone Positioning|"Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals~Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula"
10812627|NCT04347941|BG001|Baseline|Standard Care|"Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.~Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy"
10812628|NCT04347941|BG002|Baseline|Total|Total of all reporting groups
10812629|NCT04347941|FG000|Participant Flow|Prone Positioning|"Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals~Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula"
10812630|NCT04347941|FG001|Participant Flow|Standard Care|"Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.~Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy"
10812631|NCT04347941|OG000|Outcome|Prone Positioning|"Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals~Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula"
10812632|NCT04347941|OG001|Outcome|Standard Care|"Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.~Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy"
10812633|NCT04347941|OG001|Outcome|Standard of Care|Patients with suspected or confirmed COVID-19 pneumonia who are randomized to not undergo awake prone positioning but receive otherwise identical care as the awake prone positioning group.
10812634|NCT04347941|OG001|Outcome|Standard of Care|Patients with suspected or confirmed COVID-19 pneumonia requiring high flow nasal cannula oxygen who were randomized to not undergo awake prone positioning as part of their management and received otherwise identical treatment as the awake prone positioning arm.
10812635|NCT04347941|OG000|Outcome|Standard Care|"Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.~Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy"
10812636|NCT04347941|EG000|Reported Event|Prone Positioning|"Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals~Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula"
11205994|NCT02233530|BG000|Baseline|Intervention|Cognitive stimulation therapy participants. Participant received two sessions per week for seven weeks, with 14 sessions in total. Each session lasted between 45 and 60 minutes.
10812637|NCT04347941|EG001|Reported Event|Standard Care|"Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.~Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy"
10812638|NCT04308694|BG000|Baseline|Pharmacy-based Methadone Treatment|"Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.~Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy."
10812639|NCT04308694|FG000|Participant Flow|Pharmacy-based Methadone Treatment|"Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.~Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy."
11215456|NCT02299375|BG001|Baseline|Losmapimod 15 mg|Participants with COPD received losmapimod 15 mg tablets orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of ICS. Salbutamol MDI was provided as a rescue medication.
11215457|NCT02299375|BG002|Baseline|Total|Total of all reporting groups
10812640|NCT04308694|OG000|Outcome|Pharmacy-based Methadone Treatment|"Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.~Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy."
10812641|NCT04308694|EG000|Reported Event|Pharmacy-based Methadone Treatment|"Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.~Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy."
10812642|NCT03999411|BG000|Baseline|Usual Care|"Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials."
10812643|NCT03999411|BG001|Baseline|Smoking Cessation Only Intervention|"Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the Crave-to-Quit app, and two brief follow-up phone calls.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."
10812644|NCT03999411|BG002|Baseline|Combined Smoking Cessation and HIV Intervention|"Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.~vDOT emocha app: Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence."
10812645|NCT03999411|BG003|Baseline|Total|Total of all reporting groups
10812646|NCT03999411|FG000|Participant Flow|Usual Care|"Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials."
10812647|NCT03999411|FG001|Participant Flow|Smoking Cessation Only Intervention|"Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the Crave-to-Quit app, and two brief follow-up phone calls.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."
10812648|NCT03999411|FG002|Participant Flow|Combined Smoking Cessation and HIV Intervention|"Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.~vDOT emocha app: Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence."
10812649|NCT03999411|OG000|Outcome|Usual Care|"Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials."
10847656|NCT00284557|OG000|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
10812650|NCT03999411|OG001|Outcome|Smoking Cessation Only Intervention|"Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the Crave-to-Quit app, and two brief follow-up phone calls.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."
10812651|NCT03999411|OG002|Outcome|Combined Smoking Cessation and HIV Intervention|"Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.~vDOT emocha app: Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence."
10812652|NCT03999411|OG000|Outcome|All Participants Combined|Total sample of participants from all 3 arms
10812653|NCT03999411|EG000|Reported Event|Usual Care|"Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials."
10812654|NCT03999411|EG001|Reported Event|Smoking Cessation Only Intervention|"Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the Crave-to-Quit app, and two brief follow-up phone calls.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."
10812655|NCT03999411|EG002|Reported Event|Combined Smoking Cessation and HIV Intervention|"Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.~Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)~Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls.~Crave-to-Quit app: Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.~vDOT emocha app: Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence."
10812656|NCT03803605|BG000|Baseline|VRC07-523LS + Vorinostat (VOR)|"Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours.~VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)~Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)"
10812657|NCT03803605|FG000|Participant Flow|VRC07-523LS + Vorinostat (VOR)|"Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours.~VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)~Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)"
10812658|NCT03803605|OG000|Outcome|VRC07-523LS + Vorinostat (VOR)|"Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours.~VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)~Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)"
10812659|NCT03803605|EG000|Reported Event|All Enrolled Participants Completing Step 1 (Visits 1 and 2)|Participants meeting enrollment criteria who completed a Baseline leukapheresis procedure.
10812660|NCT03803605|EG001|Reported Event|Participants Receiving VRC07-523LS + Vorinostat (VOR) (Step 2/Visits 3-13)|"Participants with a Baseline RCI > 0.30 per million cells who received two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours.~VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)~Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)"
10812661|NCT03799198|BG000|Baseline|Weight Management Program (WMP) + Rx|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
10812662|NCT03799198|BG001|Baseline|Weight Management Program (WMP)|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
10812663|NCT03799198|BG002|Baseline|Total|Total of all reporting groups
10812664|NCT03799198|FG000|Participant Flow|Weight Management Program (WMP) + Rx|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
10812665|NCT03799198|FG001|Participant Flow|Weight Management Program (WMP)|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
10812666|NCT03799198|OG000|Outcome|Weight Management Program (WMP) + Rx|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
10812667|NCT03799198|OG001|Outcome|Weight Management Program (WMP)|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
10812668|NCT03799198|EG000|Reported Event|Weight Management Program (WMP) + Rx|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
10812669|NCT03799198|EG001|Reported Event|Weight Management Program (WMP)|Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
10812670|NCT03770728|BG000|Baseline|Placebo|Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812671|NCT03770728|BG001|Baseline|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812672|NCT03770728|BG002|Baseline|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
10812673|NCT03770728|BG003|Baseline|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
10812674|NCT03770728|BG004|Baseline|Total|Total of all reporting groups
10812675|NCT03770728|FG000|Participant Flow|Placebo|Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812676|NCT03770728|FG001|Participant Flow|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812677|NCT03770728|FG002|Participant Flow|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
10812678|NCT03770728|FG003|Participant Flow|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
10812679|NCT03770728|OG000|Outcome|Placebo|Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812680|NCT03770728|OG001|Outcome|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812681|NCT03770728|OG002|Outcome|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
10812682|NCT03770728|OG003|Outcome|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
10812683|NCT03770728|OG002|Outcome|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
10812684|NCT03770728|OG003|Outcome|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
10812685|NCT03770728|EG000|Reported Event|Placebo|Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812686|NCT03770728|EG001|Reported Event|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
10812687|NCT03770728|EG002|Reported Event|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
11215458|NCT02299375|FG000|Participant Flow|Placebo|Participants with COPD received placebo orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of inhaled corticosteroid (ICS). Salbutamol metered dose inhaler (MDI) was provided as a rescue medication.
11205995|NCT02233530|FG000|Participant Flow|CST Intervention|"Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention.~In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. The investigators will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location. Individuals will be allocated to groups based on religion, gender and geographical location.~CST intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall."
11205996|NCT02233530|OG000|Outcome|Intervention|Intervention group
11205997|NCT02233530|EG000|Reported Event|Intervention|Intervention group
11205998|NCT02233543|BG000|Baseline|All Participants (QVA149/Placebo)|Participants received 4 weeks of QVA149 and 4 weeks of placebo according to either of the following sequences: QVA149 first and then placebo, or placebo first and then QVA149.
11205999|NCT02233543|FG000|Participant Flow|First QVA149 (Indacaterol/Glycopyrronium), Then Placebo|Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206000|NCT02233543|FG001|Participant Flow|First Placebo, Then QVA149 (Indacaterol/Glycopyrronium)|Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206001|NCT02233543|OG000|Outcome|QVA149 (Indacaterol/Glycopyrronium)|Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206002|NCT02233543|OG001|Outcome|Placebo|Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206003|NCT02233543|EG000|Reported Event|QVA149 (Indacaterol/Glycopyrronium)|Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206004|NCT02233543|EG001|Reported Event|Placebo|Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
11206005|NCT02233647|BG000|Baseline|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
10812688|NCT03770728|EG003|Reported Event|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
10812689|NCT03760146|BG000|Baseline|Cohort 1: 20vPnC/Saline|Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
10812690|NCT03760146|BG001|Baseline|Cohort 1: 13vPnC/PPSV23|Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
10812691|NCT03760146|BG002|Baseline|Cohort 2: 20vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812692|NCT03760146|BG003|Baseline|Cohort 2: 13vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812693|NCT03760146|BG004|Baseline|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812694|NCT03760146|BG005|Baseline|Cohort 3: 13vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812695|NCT03760146|BG006|Baseline|Total|Total of all reporting groups
10812696|NCT03760146|FG000|Participant Flow|Cohort 1: 20vPnC/Saline|Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
10812697|NCT03760146|FG001|Participant Flow|Cohort 1: 13vPnC/PPSV23|Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
10812698|NCT03760146|FG002|Participant Flow|Cohort 2: 20vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812699|NCT03760146|FG003|Participant Flow|Cohort 2: 13vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812700|NCT03760146|FG004|Participant Flow|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812701|NCT03760146|FG005|Participant Flow|Cohort 3: 13vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812702|NCT03760146|OG000|Outcome|Cohort 1: 20vPnC/Saline|Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
10812703|NCT03760146|OG001|Outcome|Cohort 1: 13vPnC/PPSV23|Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
10812704|NCT03760146|OG002|Outcome|Cohort 2: 20vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812705|NCT03760146|OG003|Outcome|Cohort 2: 13vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812706|NCT03760146|OG004|Outcome|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812707|NCT03760146|OG005|Outcome|Cohort 3: 13vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812708|NCT03760146|OG000|Outcome|Cohort 2: 20vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812709|NCT03760146|OG001|Outcome|Cohort 1: 20vPnC/Saline (60-64 Years of Age)|Participants were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
10812710|NCT03760146|OG000|Outcome|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812711|NCT03760146|OG001|Outcome|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812712|NCT03760146|EG000|Reported Event|Cohort 1: 20vPnC/Saline|Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after vaccination 1).
10812713|NCT03760146|EG001|Reported Event|Cohort 1: 13vPnC/PPSV23|Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
10812714|NCT03760146|EG002|Reported Event|Cohort 2: 20vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812715|NCT03760146|EG003|Reported Event|Cohort 2: 13vPnC|Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812716|NCT03760146|EG004|Reported Event|Cohort 3: 20vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
10812717|NCT03760146|EG005|Reported Event|Cohort 3: 13vPnC|Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
10812718|NCT03760081|BG000|Baseline|ASP1650, Dose Level 1|Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812719|NCT03760081|BG001|Baseline|ASP1650, Dose Level 2|Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812720|NCT03760081|BG002|Baseline|Total|Total of all reporting groups
10812721|NCT03760081|FG000|Participant Flow|ASP1650, Dose Level 1|Participants received ASP1650, dose level 1 as intravenous infusion, every two weeks (Q2W) starting on Cycle 1 Day 1 (C1D1) for up to a maximum of 12 cycles, or a until study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812722|NCT03760081|FG001|Participant Flow|ASP1650, Dose Level 2|Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812723|NCT03760081|OG000|Outcome|ASP1650|Participants received ASP1650, dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812724|NCT03760081|OG000|Outcome|ASP1650, Dose Level 1|Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812725|NCT03760081|OG001|Outcome|ASP1650, Dose Level 2|Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812726|NCT03760081|OG000|Outcome|ASP1650, Dose Level 2|Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812727|NCT03760081|EG000|Reported Event|ASP1650, Dose Level 1|Participants received ASP1650, dose level 1 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles, or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812728|NCT03760081|EG001|Reported Event|ASP1650, Dose Level 2|Participants received ASP1650, dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until a study discontinuation criteria was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
10812729|NCT03737110|BG000|Baseline|Randomized Withdrawal Period: Rilonacept|Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.
10812730|NCT03737110|BG001|Baseline|Randomized Withdrawal Period: Placebo|Double-blind placebo SC injections once weekly.
10812731|NCT03737110|BG002|Baseline|Total|Total of all reporting groups
10812732|NCT03737110|FG000|Participant Flow|Run-in Period|"Single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥ 12 and < 18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and <18 years old) injections once weekly for 12 weeks.~Participants still in the Run-in Period at the time that the Randomized Withdrawal Period has ended (ie, when the prespecified number of primary efficacy endpoint events have occurred) and the Long-Term Extension (LTE) Period is opened will have the option to enter the LTE directly when they have completed the RI period and have met the definition of clinical response or to withdraw from the study."
10812733|NCT03737110|FG001|Participant Flow|Randomized Withdrawal Period: Rilonacept|"Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point numerical rating scale (NRS) and have 1 C-reactive protein (CRP) value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection.~Upon completion of the RW period (ie, when the prespecified number of primary efficacy endpoint events has occurred), all participants who did not discontinue study drug have an option to continue treatment with open-label rilonacept in the LTE period or to withdraw from the study."
10812734|NCT03737110|FG002|Participant Flow|Randomized Withdrawal Period: Placebo|"Double-blind placebo SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection.~Upon completion of the RW period (ie, when the prespecified number of primary efficacy endpoint events has occurred), all participants who did not discontinue study drug have an option to continue treatment with open-label rilonacept in the LTE period or to withdraw from the study."
11206006|NCT02233647|FG000|Participant Flow|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
10812735|NCT03737110|OG000|Outcome|Randomized Withdrawal Period: Rilonacept|Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.
10812736|NCT03737110|OG001|Outcome|Randomized Withdrawal Period: Placebo|Double-blind placebo SC injections once weekly.
10812737|NCT03737110|OG000|Outcome|Randomized Withdrawal Period: Rilonacept, Before Bailout Rilonacept|Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.
10812738|NCT03737110|OG001|Outcome|Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept|"Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection."
10812739|NCT03737110|OG002|Outcome|Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept|Double-blind placebo SC injections once weekly.
10812740|NCT03737110|OG003|Outcome|Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept|"Double-blind placebo SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection."
10812741|NCT03737110|OG002|Outcome|Randomized Withdrawal Period: Placebo|Double-blind placebo SC injections once weekly.
10812742|NCT03737110|OG000|Outcome|Run-in Period|Single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥ 12 and < 18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and <18 years old) injections once weekly for 12 weeks.
10812743|NCT03737110|OG000|Outcome|Run-in Period: ECHO Abnormality at Baseline|Participants with an ECHO abnormality (ST-Elevation) at RI period baseline.
10812744|NCT03737110|OG001|Outcome|Run-in Period: ECG Abnormality (ST-Elevation) at Baseline|Participants with an ECG abnormality (ST-elevation) at RI period baseline.
10812745|NCT03737110|OG002|Outcome|Run-in Period: ECG Abnormality (PR Depression) at Baseline|Participants with an ECG abnormality (PR depression) at RI period baseline.
10812746|NCT03737110|EG000|Reported Event|Run-in Period|Single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥ 12 and < 18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in pediatric subjects ≥12 and <18 years old) injections once weekly for 12 weeks.
10812747|NCT03737110|EG001|Reported Event|Randomized Withdrawal Period: Rilonacept Only, Before Bailout Rilonacept|Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.
10812748|NCT03737110|EG002|Reported Event|Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept|"Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and < 18 years old) SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection."
10812749|NCT03737110|EG003|Reported Event|Randomized Withdrawal Period: Placebo Only, Before Bailout Rilonacept|Double-blind placebo SC injections once weekly.
10812750|NCT03737110|EG004|Reported Event|Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept|"Double-blind placebo SC injections once weekly.~Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection."
10812751|NCT03713684|BG000|Baseline|Placebo|Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812752|NCT03713684|BG001|Baseline|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812753|NCT03713684|BG002|Baseline|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
10812754|NCT03713684|BG003|Baseline|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
10812755|NCT03713684|BG004|Baseline|Total|Total of all reporting groups
10812756|NCT03713684|FG000|Participant Flow|Placebo|Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
10812757|NCT03713684|FG001|Participant Flow|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812758|NCT03713684|FG002|Participant Flow|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
10812759|NCT03713684|FG003|Participant Flow|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
10812760|NCT03713684|OG000|Outcome|Placebo|Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812761|NCT03713684|OG001|Outcome|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812762|NCT03713684|OG002|Outcome|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
10812763|NCT03713684|OG003|Outcome|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
10812764|NCT03713684|EG000|Reported Event|Placebo|Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812765|NCT03713684|EG001|Reported Event|Efpeglenatide 2 mg|Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
10812766|NCT03713684|EG002|Reported Event|Efpeglenatide 4 mg|Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
10812767|NCT03713684|EG003|Reported Event|Efpeglenatide 6 mg|Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
10812768|NCT03644550|BG000|Baseline|1/LMB- 100+Pembrolizumab|"LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.~LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.~LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial)..~Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria."
10812769|NCT03644550|FG000|Participant Flow|1/LMB- 100+Pembrolizumab|"LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.~LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.~LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).~Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria."
10812770|NCT03644550|OG000|Outcome|1/LMB- 100+Pembrolizumab|"LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.~LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.~LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).~Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria."
10812771|NCT03644550|OG000|Outcome|1/LMB- 100+Pembrolizumab|"LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.~LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.~LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial)..~Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria."
10812772|NCT03644550|EG000|Reported Event|1/LMB- 100+Pembrolizumab|"LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.~LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.~LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).~Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria."
10812773|NCT03557970|BG000|Baseline|Assay Positive|Participants with ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Sensitivity is defined as an IC50 that is <=20% of the median IC50.
11244325|NCT02510001|OG000|Outcome|Dose Escalation Phase Dose 1.|"Crizotinib 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
11244326|NCT02510001|OG001|Outcome|Dose Escalation Phase Dose 2.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10812774|NCT03557970|BG001|Baseline|Assay Negative|Participants lacking ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Lack of sensitivity is defined as an IC50 that is >20% of the median IC50.
10812775|NCT03557970|BG002|Baseline|Total|Total of all reporting groups
10812776|NCT03557970|FG000|Participant Flow|Assay Positive|Participants with ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Sensitivity is defined as an IC50 that is <=20% of the median IC50.
10812777|NCT03557970|FG001|Participant Flow|Assay Negative|Participants lacking ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Lack of sensitivity is defined as an IC50 that is >20% of the median IC50.
10812778|NCT03557970|OG000|Outcome|Assay Positive|Participants with ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Sensitivity is defined as an IC50 that is <=20% of the median IC50.
10812779|NCT03557970|OG001|Outcome|Assay Negative|Participants lacking ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Lack of sensitivity is defined as an IC50 that is >20% of the median IC50.
10812780|NCT03557970|EG000|Reported Event|Assay Positive|Participants with ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Sensitivity is defined as an IC50 that is <=20% of the median IC50.
11244327|NCT02510001|OG002|Outcome|Dose Escalation Phase Dose 3.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
11244328|NCT02510001|OG003|Outcome|Dose Escalation Phase Dose 4.|"Crizotinib 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle."
10812781|NCT03557970|EG001|Reported Event|Assay Negative|Participants lacking ex vivo sensitivity to study drug according to a cell viability assay performed on participant bone marrow or peripheral blood cells. Lack of sensitivity is defined as an IC50 that is >20% of the median IC50.
10812782|NCT03369197|BG000|Baseline|Intervention: Nasal Mask|"Nasal anesthesia mask with positive pressure~Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve"
10812783|NCT03369197|BG001|Baseline|Control: Nasal Cannula|"Nasal Cannula with standard care~Control: Nasal Cannula: Nasal cannula as per usual care"
10812784|NCT03369197|BG002|Baseline|Total|Total of all reporting groups
10812785|NCT03369197|FG000|Participant Flow|Intervention: Nasal Mask|"Nasal anesthesia mask with positive pressure~Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve"
10812786|NCT03369197|FG001|Participant Flow|Control: Nasal Cannula|"Nasal Cannula with standard care~Control: Nasal Cannula: Nasal cannula as per usual care"
10812787|NCT03369197|OG000|Outcome|Intervention: Nasal Mask|"Nasal anesthesia mask with positive pressure~Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve"
10812788|NCT03369197|OG001|Outcome|Control: Nasal Cannula|"Nasal Cannula with standard care~Control: Nasal Cannula: Nasal cannula as per usual care"
10812789|NCT03369197|EG000|Reported Event|Intervention: Nasal Mask|"Nasal anesthesia mask with positive pressure~Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve"
10812790|NCT03369197|EG001|Reported Event|Control: Nasal Cannula|"Nasal Cannula with standard care~Control: Nasal Cannula: Nasal cannula as per usual care"
10821807|NCT00071760|EG000|Reported Event|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
10821808|NCT00071799|BG000|Baseline|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
10821809|NCT00071799|BG001|Baseline|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
10821810|NCT00071799|BG002|Baseline|Total|Total of all reporting groups
10821811|NCT00071799|FG000|Participant Flow|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
10821812|NCT00071799|FG001|Participant Flow|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
10821813|NCT00071799|OG000|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
10821814|NCT00071799|OG001|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
10821815|NCT00071799|OG000|Outcome|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
11244329|NCT02510001|OG000|Outcome|Dose Escalation Phase Dose 1.|Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10812791|NCT03368196|BG000|Baseline|DS-8201a|Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
10812792|NCT03368196|FG000|Participant Flow|DS-8201a|Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
10812793|NCT03368196|OG000|Outcome|DS-8201a|Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
10812794|NCT03368196|EG000|Reported Event|DS-8201a|Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
11206007|NCT02233647|OG000|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
10812800|NCT02979587|BG000|Baseline|Implanted Pivotal Harmony TPV Subjects|This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.
10812801|NCT02979587|FG000|Participant Flow|Implanted Pivotal Harmony TPV Subjects|This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.
10812802|NCT02979587|OG000|Outcome|Catheterized Cohort|Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
10812803|NCT02979587|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable data at 6 months.
10812804|NCT02979587|OG000|Outcome|Attempted Implant Cohort|Subjects included in this analysis were those who had an attempted Harmony TPV implant
10812805|NCT02979587|OG000|Outcome|Attempted Implant Cohort|Subjects included in this analysis were those who had an attempted Harmony TPV implant.
10812806|NCT02979587|OG000|Outcome|Implanted > 24 Hours Cohort|Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable data at the given timepoint.
11206008|NCT02233647|EG000|Reported Event|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
10812807|NCT02979587|EG000|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV.
10812808|NCT02964039|BG000|Baseline|Error Reduction|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error reduction mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke."
10812809|NCT02964039|BG001|Baseline|Error Augmentation|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error augmentation mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke."
10812810|NCT02964039|BG002|Baseline|Activity Matched Control|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in transparent mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke."
10812811|NCT02964039|BG003|Baseline|Total|Total of all reporting groups
11206009|NCT02233738|BG000|Baseline|Group Motivational Interviewing (GMI)|Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
11206010|NCT02233738|BG001|Baseline|Control Treatment Condition (CT)|Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity', participants will anonymously submit questions on involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion money management with feedback (2 sessions), cooking-home maintenance, and psycho-education about substance use.
10812812|NCT02964039|FG000|Participant Flow|Error Reduction|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error reduction mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke."
10812813|NCT02964039|FG001|Participant Flow|Error Augmentation|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error augmentation mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke."
10812814|NCT02964039|FG002|Participant Flow|Activity Matched Control|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in transparent mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke."
10812815|NCT02964039|OG000|Outcome|Error Reduction|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error reduction mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke."
10812816|NCT02964039|OG001|Outcome|Error Augmentation|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error augmentation mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke."
10812817|NCT02964039|OG002|Outcome|Activity Matched Control|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in transparent mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke."
10821816|NCT00071799|OG001|Outcome|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
10821817|NCT00071799|OG002|Outcome|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
11206011|NCT02233738|BG002|Baseline|Total|Total of all reporting groups
11206012|NCT02233738|FG000|Participant Flow|Group Motivational Interviewing (GMI)|Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
11244330|NCT02510001|OG001|Outcome|Dose Escalation Phase Dose 2.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
10812818|NCT02964039|EG000|Reported Event|Error Reduction|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error reduction mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke."
10812819|NCT02964039|EG001|Reported Event|Error Augmentation|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in error augmentation mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke."
10812820|NCT02964039|EG002|Reported Event|Activity Matched Control|"Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in transparent mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.~Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke."
10812821|NCT02930889|BG000|Baseline|Prostate Artery Embolization|"Prostate Artery Embolization~Prostate Artery Embolization: Prostate Artery Embolization"
10812822|NCT02930889|FG000|Participant Flow|Prostate Artery Embolization|"Prostate Artery Embolization~Prostate Artery Embolization: Prostate Artery Embolization"
10812823|NCT02930889|OG000|Outcome|Prostate Artery Embolization|"Prostate Artery Embolization~Prostate Artery Embolization: Prostate Artery Embolization"
10812824|NCT02930889|EG000|Reported Event|Prostate Artery Embolization|"Prostate Artery Embolization~Prostate Artery Embolization: Prostate Artery Embolization"
10812825|NCT02919618|BG000|Baseline|Patients Overall Who Received SBRT|"Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.~Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)"
10812826|NCT02919618|FG000|Participant Flow|Patients Overall Who Received SBRT|"Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.~Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)"
10812827|NCT02919618|OG000|Outcome|Number of Events|Number of serious adverse events that occurred.
10812828|NCT02919618|OG000|Outcome|Patients With ICD-treated VT Indication|Sixteen evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with an ICD-treated VT indication.
10812829|NCT02919618|OG001|Outcome|Patients With PVC-Related Cardiomyopathy Indication|Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.
10812830|NCT02919618|OG000|Outcome|6 Month Overall Survival|Overall survival at the 6 month post-SBRT time point of all 19 patients enrolled.
10812831|NCT02919618|OG001|Outcome|12 Month Overall Survival|Overall survival at the 12 month post-SBRT time point of the 18 remaining patients from the 6 month time point.
10812832|NCT02919618|OG000|Outcome|Number of Events|Number of adverse events that occurred.
10812833|NCT02919618|OG000|Outcome|Baseline|Baseline mean scores for all 18 evaluable patients at the 6 week time point.
10812834|NCT02919618|OG001|Outcome|6 Week|6 week mean scores for all 18 evaluable patients at the 6 week time point.
10812835|NCT02919618|OG002|Outcome|6 Month|6 month mean scores for all 16 evaluable patients at the 6 month time point. 2 patients did not return the SF-36 survey for the 6 month follow up.
10812836|NCT02919618|OG003|Outcome|12 Month|12 month mean scores for all 13 evaluable patients at the 12 month time point. 5 patients had expired prior to the 12 month time point.
10812837|NCT02919618|OG000|Outcome|Patients Overall Who Received SBRT|"Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.~Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)"
10812838|NCT02919618|OG000|Outcome|Patients Overall Who Received SBRT|"Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.~Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)"
10812839|NCT02919618|EG000|Reported Event|Patients Overall Who Received SBRT|"Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.~Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)"
10812840|NCT02844946|BG000|Baseline|ACT on Life|"One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.~Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations."
10812841|NCT02844946|BG001|Baseline|Treatment as Usual|Veterans will continue receiving care as usual.
10812842|NCT02844946|BG002|Baseline|Total|Total of all reporting groups
10812843|NCT02844946|FG000|Participant Flow|ACT on Life|"One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.~Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations."
10812844|NCT02844946|FG001|Participant Flow|Treatment as Usual|Veterans will continue receiving care as usual.
10812845|NCT02844946|OG000|Outcome|ACT on Life|"One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.~Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations."
10812846|NCT02844946|OG001|Outcome|Treatment as Usual|Veterans will continue receiving care as usual.
10812847|NCT02844946|EG000|Reported Event|ACT on Life|"One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.~Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations."
10812848|NCT02844946|EG001|Reported Event|Treatment as Usual|Veterans will continue receiving care as usual.
10812849|NCT02675114|BG000|Baseline|Surgical Aortic Valve Replacement (SAVR)|SAVR with a commercially available bioprosthetic valve.
10812850|NCT02675114|BG001|Baseline|Transcatheter Aortic Valve Replacement (TAVR)|TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
10812851|NCT02675114|BG002|Baseline|Total|Total of all reporting groups
10812852|NCT02675114|FG000|Participant Flow|Surgical Aortic Valve Replacement (SAVR)|SAVR with a commercially available bioprosthetic valve.
10812853|NCT02675114|FG001|Participant Flow|Transcatheter Aortic Valve Replacement (TAVR)|TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
10812854|NCT02675114|OG000|Outcome|Surgical Aortic Valve Replacement (SAVR)|SAVR with a commercially available bioprosthetic valve.
10812855|NCT02675114|OG001|Outcome|Transcatheter Aortic Valve Replacement (TAVR)|TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
10812856|NCT02675114|EG000|Reported Event|Surgical Aortic Valve Replacement (SAVR)|SAVR with a commercially available bioprosthetic valve.
11206013|NCT02233738|FG001|Participant Flow|Control Treatment Condition (CT)|Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity', participants will anonymously submit questions on involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion money management with feedback (2 sessions), cooking-home maintenance, and psycho-education about substance use.
11206014|NCT02233738|OG000|Outcome|GMI - Standard Ethanol Content Units (SECs) at Baseline|GMI - Standard Ethanol Content Units (SECs) at Baseline
11206015|NCT02233738|OG001|Outcome|LSEG - Standard Ethanol Content Units (SECs) at Baseline|LSEG - Standard Ethanol Content Units (SECs) at Baseline
11206016|NCT02233738|OG000|Outcome|GMI - Standard Ethanol Content Units (SECs) at 1 Month|GMI - Standard Ethanol Content Units (SECs) at 1 month
11206017|NCT02233738|OG001|Outcome|LSEG - Standard Ethanol Content Units (SECs) at 1 Month|LSEG - Standard Ethanol Content Units (SECs) at 1 month
11206018|NCT02233738|OG000|Outcome|GMI - Standard Ethanol Content Units (SECs) at 3 Months|GMI - Standard Ethanol Content Units (SECs) at 3 months
11206019|NCT02233738|OG001|Outcome|LSEG - Standard Ethanol Content Units (SECs) at 3 Months|LSEG - Standard Ethanol Content Units (SECs) at 3 months
11206020|NCT02233738|OG000|Outcome|GMI - Standard Ethanol Content Units (SECs) at 6 Months|GMI -Standard Ethanol Content Units (SECs) at 6 months
11206021|NCT02233738|OG001|Outcome|LSEG - Standard Ethanol Content Units (SECs) at 6 Months|LSEG - Standard Ethanol Content Units (SECs) at 6 months
11206022|NCT02233738|OG000|Outcome|GMI - Peak SEC at Baseline|GMI - Peak SEC at Baseline
10812857|NCT02675114|EG001|Reported Event|Transcatheter Aortic Valve Replacement (TAVR)|TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
10812858|NCT02564796|BG000|Baseline|Control|"Group II (non-treatment group): Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.~Iron: Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks."
10812859|NCT02564796|BG001|Baseline|Epoetin Alfa and Iron Supplements|"Group I (treatment group): Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.~Epoetin Alfa and Iron: Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks."
10812860|NCT02564796|BG002|Baseline|Total|Total of all reporting groups
10812861|NCT02564796|FG000|Participant Flow|Control|"Group II (non-treatment group): Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.~Iron: Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks."
10812862|NCT02564796|FG001|Participant Flow|Epoetin Alfa and Iron Supplements|"Group I (treatment group): Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.~Epoetin Alfa and Iron: Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks."
10812863|NCT02564796|OG000|Outcome|Control|"Group II (non-treatment group): Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.~Iron: Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks."
10812864|NCT02564796|OG001|Outcome|Epoetin Alfa and Iron Supplements|"Group I (treatment group): Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.~Epoetin Alfa and Iron: Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks."
10812865|NCT02564796|EG000|Reported Event|Control|"Group II (non-treatment group): Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.~Iron: Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks."
10812866|NCT02564796|EG001|Reported Event|Epoetin Alfa and Iron Supplements|"Group I (treatment group): Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.~Epoetin Alfa and Iron: Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks."
10812867|NCT02562716|BG000|Baseline|mFOLFIRINOX ->Surg ->mFOLFIRINOX|Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
10812868|NCT02562716|BG001|Baseline|Gem/Nab-P ->Surg ->Gem/Nab-P|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
10812869|NCT02562716|BG002|Baseline|Total|Total of all reporting groups
10812870|NCT02562716|FG000|Participant Flow|mFOLFIRINOX ->Surg ->mFOLFIRINOX|Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
10812871|NCT02562716|FG001|Participant Flow|Gem/Nab-P ->Surg ->Gem/Nab-P|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
10821818|NCT00071799|OG003|Outcome|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
10821819|NCT00071799|EG000|Reported Event|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
11206023|NCT02233738|OG001|Outcome|LSEG - Peak SEC at Baseline|LSEG - Peak SEC at Baseline
11206024|NCT02233738|OG000|Outcome|GMI - Peak SEC at 1 Month|GMI - Peak SEC at 1 month
11206025|NCT02233738|OG001|Outcome|LSEG - Peak SEC at 1 Month|LSEG - Peak SEC at 1 month
11206026|NCT02233738|OG000|Outcome|GMI - Peak SEC at 3 Months|GMI - Peak SEC at 3 months
11206027|NCT02233738|OG001|Outcome|LSEG - Peak SEC at 3 Months|LSEG - Peak SEC at 3 months
11206028|NCT02233738|OG000|Outcome|GMI - Peak SEC at 6 Months|GMI - Peak SEC at 6 months
11206029|NCT02233738|OG001|Outcome|LSEG - Peak SEC at 6 Months|LSEG - Peak SEC at 6 months
11206030|NCT02233738|OG000|Outcome|GMI -Alcohol Drink Days at Baseline|GMI - Alcohol Drink Days at Baseline
10812872|NCT02562716|OG000|Outcome|mFOLFIRINOX ->Surg ->mFOLFIRINOX|Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
10812873|NCT02562716|OG001|Outcome|Gem/Nab-P ->Surg ->Gem/Nab-P|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
10812874|NCT02562716|OG000|Outcome|mFOLFIRINOX->Surg->mFOLFIRINOX|Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
10812875|NCT02562716|OG001|Outcome|Gem/Nab-P->Surg->Gem/Nab-P|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
10812876|NCT02562716|EG000|Reported Event|mFOLFIRINOX->Surg->mFOLFIRINOX|"Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.~Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality."
10812877|NCT02562716|EG001|Reported Event|Gem/Nab-P->Surg->Gem/Nab-P|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.~Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality."
10812878|NCT01803854|BG000|Baseline|Gulf War Era Veterans|All Veterans who served in the uniformed services during 1990-1991 who signed consent forms, completed a survey, and provided a blood sample are included in the cohort.
10812879|NCT01803854|FG000|Participant Flow|Gulf War Era Veterans|All Veterans who served in the uniformed services during 1990-1991 who signed consent forms, completed a survey, and provided a blood sample are included in the cohort.
10812880|NCT01803854|OG000|Outcome|VHA Health Care Utilization|Use of VHA for health care in the past year
10812881|NCT01803854|OG000|Outcome|Deployment Status|Self-reported deployment status during 1990-1991 Gulf War
10812882|NCT01803854|EG000|Reported Event|Gulf War Era Veterans|All Veterans who served in the uniformed services during 1990-1991 who signed consent forms, completed a survey, and provided a blood sample are included in the cohort.
10812883|NCT01472081|BG000|Baseline|Arm S: SUN + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812884|NCT01472081|BG001|Baseline|Arm S: SUN + NIV5|Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812885|NCT01472081|BG002|Baseline|Arm P: PAZ + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812886|NCT01472081|BG003|Baseline|Arm I-1: IPI1 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10821820|NCT00071799|EG001|Reported Event|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
10821821|NCT00071799|EG002|Reported Event|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
10812887|NCT01472081|BG004|Baseline|Arm I-3: IPI3 + NIV1|"Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812888|NCT01472081|BG005|Baseline|Arm IN-3: IPI3 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812889|NCT01472081|BG006|Baseline|Total|Total of all reporting groups
10812890|NCT01472081|FG000|Participant Flow|Arm S: SUN + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812891|NCT01472081|FG001|Participant Flow|Arm S: SUN + NIV5|Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812892|NCT01472081|FG002|Participant Flow|Arm P: PAZ + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812893|NCT01472081|FG003|Participant Flow|Arm I-1: IPI1 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812894|NCT01472081|FG004|Participant Flow|Arm I-3: IPI3 + NIV1|"Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812895|NCT01472081|FG005|Participant Flow|Arm IN-3: IPI3 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812896|NCT01472081|OG000|Outcome|Arm S: SUN + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812897|NCT01472081|OG001|Outcome|Arm S: SUN + NIV5|Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
11206031|NCT02233738|OG001|Outcome|LSEG - Alcohol Drink Days at Baseline|LSEG - Alcohol Drink Days at Baseline
10812898|NCT01472081|OG002|Outcome|Arm P: PAZ + NIV2|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812899|NCT01472081|OG003|Outcome|Arm I-1: IPI1 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812900|NCT01472081|OG004|Outcome|Arm I-3: IPI3 + NIV1|"Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812901|NCT01472081|OG005|Outcome|Arm IN-3: IPI3 + NIV3|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812902|NCT01472081|EG000|Reported Event|SUNITINIB+NIVOLUMAB|Nivolumab (2mg/kg or 5mg/kg)administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
10812903|NCT01472081|EG001|Reported Event|PAZOPANIB+NIVOLUMAB|Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
11206032|NCT02233738|OG000|Outcome|GMI - Alcohol Drink Days at 1 Month|GMI - Alcohol Drink Days at 1 month
11206033|NCT02233738|OG001|Outcome|LSEG - Alcohol Drink Days at 1 Month|LSEG - Alcohol Drink Days at 1 month
11206034|NCT02233738|OG000|Outcome|GMI - Alcohol Drink Days at 3 Months|GMI - Alcohol Drink Days at 3 months
11206035|NCT02233738|OG001|Outcome|LSEG - Alcohol Drink Days at 3 Months|LSEG - Alcohol Drink Days at 3 months
11206036|NCT02233738|OG000|Outcome|GMI - Alcohol Drink Days at 6 Months|GMI - Alcohol Drink Days at 6 months
11206037|NCT02233738|OG001|Outcome|LSEG - Alcohol Drink Days at 6 Months|LSEG - Alcohol Drink Days at 6 months
10812904|NCT01472081|EG002|Reported Event|NIVO 3+IPI 1 (MG/KG)|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812905|NCT01472081|EG003|Reported Event|NIVO 1+IPI 3 (MG/KG)|"Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812906|NCT01472081|EG004|Reported Event|NIVO 3+IPI 3 (MG/KG)|"Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.~Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays."
10812907|NCT01309672|BG000|Baseline|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
10812908|NCT01309672|FG000|Participant Flow|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
10812909|NCT01309672|OG000|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
10812910|NCT01309672|OG000|Outcome|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
10812911|NCT01309672|EG000|Reported Event|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
10812912|NCT01131169|BG000|Baseline|Relapsed Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
10812913|NCT01131169|BG001|Baseline|High-risk Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
10812914|NCT01131169|BG002|Baseline|Total|Total of all reporting groups
10812915|NCT01131169|FG000|Participant Flow|Relapsed Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
10812916|NCT01131169|FG001|Participant Flow|High-risk Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
10812917|NCT01131169|OG000|Outcome|Relapsed Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
10812918|NCT01131169|OG001|Outcome|High-risk Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
10812919|NCT01131169|OG001|Outcome|High-risk Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
10812920|NCT01131169|EG000|Reported Event|Relapsed Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
10821822|NCT00071799|EG003|Reported Event|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
10812921|NCT01131169|EG001|Reported Event|High-risk Multiple Myeloma|This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
10812922|NCT00774345|BG000|Baseline|Lenalidomide|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812923|NCT00774345|BG001|Baseline|Placebo|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812924|NCT00774345|BG002|Baseline|Total|Total of all reporting groups
10812925|NCT00774345|FG000|Participant Flow|Lenalidomide|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812926|NCT00774345|FG001|Participant Flow|Placebo|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812927|NCT00774345|OG000|Outcome|Lenalidomide|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812928|NCT00774345|OG001|Outcome|Placebo|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812929|NCT00774345|EG000|Reported Event|Lenalidomide|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812930|NCT00774345|EG001|Reported Event|Placebo|2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
10812931|NCT00457951|BG000|Baseline|Open-Label|Open-Label ODSH
10812932|NCT00457951|BG001|Baseline|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
10812933|NCT00457951|BG002|Baseline|ODSH Treatment Group|ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
10812934|NCT00457951|BG003|Baseline|Total|Total of all reporting groups
10812935|NCT00457951|FG000|Participant Flow|Open Label|"Open Label~The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.~After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis."
10812936|NCT00457951|FG001|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
10812937|NCT00457951|FG002|Participant Flow|ODSH Treatment Group|Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
10812938|NCT00457951|OG000|Outcome|0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
10812939|NCT00457951|OG001|Outcome|Randomized, Blinded, ODSH Arm|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
10812940|NCT00457951|EG000|Reported Event|Open Label|"Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.~Open-Label: ODSH administered open-label"
10812941|NCT00457951|EG001|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
10812942|NCT00457951|EG002|Reported Event|ODSH Treatment Group|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
10812943|NCT00345943|BG000|Baseline|Adolescents With Bulimia Nervosa or Subclinical BN|"Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812944|NCT00345943|BG001|Baseline|Healthy Control Adolescents|"Healthy control adolescents~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812945|NCT00345943|BG002|Baseline|Total|Total of all reporting groups
10812946|NCT00345943|FG000|Participant Flow|Adolescents With Bulimia Nervosa or Subclinical BN|"Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812947|NCT00345943|FG001|Participant Flow|Healthy Control Adolescents|"Healthy control adolescents~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812948|NCT00345943|OG000|Outcome|Adolescents With Bulimia Nervosa or Subclinical BN|"Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812949|NCT00345943|OG001|Outcome|Healthy Control Adolescents|"Healthy control adolescents~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812950|NCT00345943|EG000|Reported Event|Adolescents With Bulimia Nervosa or Subclinical BN|"Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812951|NCT00345943|EG001|Reported Event|Healthy Control Adolescents|"Healthy control adolescents~MRI: Magnetic Resonance Imaging scans~Neuropsychological Testing: Neuropsychological tests"
10812952|NCT00258427|BG000|Baseline|Marrow Isolex|Bone marrow processed using Isolex300i
11206038|NCT02233738|OG000|Outcome|GMI - Binge Drink Days at Baseline|GMI - Binge Drink Days at Baseline
10812953|NCT00258427|BG001|Baseline|USB Arm|No processing
10812954|NCT00258427|BG002|Baseline|Marrow Clinimacs|Bone marrow processed using CliniMACS
10812955|NCT00258427|BG003|Baseline|Sibling withoutCliniMACS|sibling donor without use of CliniMACS system
10812956|NCT00258427|BG004|Baseline|Total|Total of all reporting groups
10812957|NCT00258427|FG000|Participant Flow|Marrow Isolex|Bone marrow processed using Isolex300i
10812958|NCT00258427|FG001|Participant Flow|USB Arm|No processing
10812959|NCT00258427|FG002|Participant Flow|Marrow Clinimacs|Bone marrow processed using CliniMACS
10812960|NCT00258427|FG003|Participant Flow|Sibling withoutCliniMACS|sibling donor without use of CliniMACS system
10812961|NCT00258427|OG000|Outcome|Marrow Isolex|Bone marrow processed using Isolex300i
10812962|NCT00258427|OG001|Outcome|USB Arm|No processing
10812963|NCT00258427|OG002|Outcome|Marrow Clinimacs|Bone marrow processed using CliniMACS
10812964|NCT00258427|OG003|Outcome|Sibling withoutCliniMACS|sibling donor without use of CliniMACS system
10812965|NCT00258427|EG000|Reported Event|Marrow Isolex|Bone marrow processed using Isolex300i
10812966|NCT00258427|EG001|Reported Event|USB Arm|No processing
10812967|NCT00258427|EG002|Reported Event|Marrow Clinimacs|Bone marrow processed using CliniMACS
10812968|NCT00258427|EG003|Reported Event|Sibling withoutCliniMACS|sibling donor without use of CliniMACS system
10821823|NCT00071812|BG000|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821824|NCT00071812|BG001|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
11206039|NCT02233738|OG001|Outcome|LSEG - Binge Drink Days at Baseline|LSEG - Binge Drink Days at Baseline
11206040|NCT02233738|OG000|Outcome|GMI - Binge Drink Days at 1 Month|GMI - Binge Drink Days at 1 month
11206041|NCT02233738|OG001|Outcome|LSEG - Binge Drink Days at 1 Month|LSEG - Binge Drink Days at 1 month
10821825|NCT00071812|BG002|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821826|NCT00071812|BG003|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821827|NCT00071812|BG004|Baseline|Total|Total of all reporting groups
10821828|NCT00071812|FG000|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study.
10821829|NCT00071812|FG001|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
10821830|NCT00071812|FG002|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
10821831|NCT00071812|FG003|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 24-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
10821832|NCT00071812|OG000|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821833|NCT00071812|OG001|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821834|NCT00071812|OG002|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821835|NCT00071812|OG003|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
11206042|NCT02233738|OG000|Outcome|GMI - Binge Drink Days at 6 Months|GMI - Binge Drink Days at 6 Months
11206043|NCT02233738|OG001|Outcome|LSEG - Binge Drink Days at 6 Months|LSEG - Binge Drink Days at 6 Months
11206044|NCT02233738|OG000|Outcome|GMI - Illicit Drug Use Days at Baseline|GMI - Illicit Drug Use Days at Baseline
11206045|NCT02233738|OG001|Outcome|LSEG - Illicit Drug Use Days at Baseline|LSEG - Illicit Drug Use Days at Baseline
11206046|NCT02233738|OG000|Outcome|GMI - Illicit Drug Use Days at 1 Month|GMI - Illicit Drug Use Days at 1 month
11206047|NCT02233738|OG001|Outcome|LSEG - Illicit Drug Use Days at 1 Month|LSEG - Illicit Drug Use Days at 1 month
10821836|NCT00071812|OG004|Outcome|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
10812969|NCT03722810|BG000|Baseline|Active Comparator: Patient Interview|"This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.~Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.~GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher."
10812970|NCT03722810|BG001|Baseline|Sham Comparator: Document|"In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.~Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching."
10812971|NCT03722810|BG002|Baseline|Total|Total of all reporting groups
10812972|NCT03722810|FG000|Participant Flow|Active Comparator: Patient Interview|"This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.~Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.~GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher."
10812973|NCT03722810|FG001|Participant Flow|Sham Comparator: Document|"In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.~Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching."
10812974|NCT03722810|OG000|Outcome|Active Comparator: Patient Interview|"This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.~Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.~GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher."
10812975|NCT03722810|OG001|Outcome|Sham Comparator: Document|"In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.~Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching."
10812976|NCT03722810|OG000|Outcome|Female|Female participants
10812977|NCT03722810|OG001|Outcome|Male|Male participants
10812978|NCT03722810|OG000|Outcome|Studied Another Subject as an Undergraduate|Previously studied another subject as an undergraduate
10812979|NCT03722810|OG001|Outcome|Not Previously Studied Another Subject|Not previously studied another subject as an undergraduate
10812980|NCT03722810|OG000|Outcome|Experience of a Chronic Illness|Experience of a chronic illness in the students themselves or a close relative.
10812981|NCT03722810|OG001|Outcome|No Experience of a Chronic Illness|No experience of a chronic illness in the students themselves or a close relative
10812982|NCT03722810|OG000|Outcome|Correlation Between Students' and Teachers' PPOS-D12 Scores|Relationship between change in students' PPOS-D12 scores and their teachers' PPOS-D12 scores
10812983|NCT03722810|EG000|Reported Event|Active Comparator: Patient Interview|"This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.~Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.~GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher."
10821837|NCT00071812|EG000|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821838|NCT00071812|EG001|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10812984|NCT03722810|EG001|Reported Event|Sham Comparator: Document|"In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.~Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching."
10812985|NCT00000125|BG000|Baseline|Observation|Observation only
10812986|NCT00000125|BG001|Baseline|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
10812987|NCT00000125|BG002|Baseline|Total|Total of all reporting groups
10812988|NCT00000125|FG000|Participant Flow|Observation|Close Observation
10812989|NCT00000125|FG001|Participant Flow|Treatment|Topical ocular hypotensive eye drops.
10812990|NCT00000125|OG000|Outcome|Observation|Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
10812991|NCT00000125|OG001|Outcome|Treatment|Topical ocular hypotensive eye drops from February 1994 through March 2009.
10812992|NCT00000125|EG000|Reported Event|Observation|Observation only from February 1994 to June 2002 .
10812993|NCT00000125|EG001|Reported Event|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
10812994|NCT00000134|BG000|Baseline|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10812995|NCT00000134|BG001|Baseline|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
10812996|NCT00000134|BG002|Baseline|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10812997|NCT00000134|BG003|Baseline|Total|Total of all reporting groups
10812998|NCT00000134|FG000|Participant Flow|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10812999|NCT00000134|FG001|Participant Flow|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
11206048|NCT02233738|OG000|Outcome|GMI - Illicit Drug Use Days at 3 Months|GMI - Illicit Drug Use Days at 3 months
11206049|NCT02233738|OG001|Outcome|LSEG - Illicit Drug Use Days at 3 Months|LSEG - Illicit Drug Use Days at 3 months
11206050|NCT02233738|OG000|Outcome|GMI - Illicit Drug Use Days at 6 Months|GMI - Illicit Drug Use Days at 6 months
11206051|NCT02233738|OG001|Outcome|LSEG - Illicit Drug Use Days at 6 Months|LSEG - Illicit Drug Use Days at 6 months
11206052|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder Treatment Sessions at Baseline|GMI - Substance Use Disorder Treatment Sessions at Baseline
11206053|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder Treatment Sessions at Baseline|LSEG - Substance Use Disorder Treatment Sessions at Baseline
11206054|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder Treatment Sessions at 1 Month|GMI - Substance Use Disorder Treatment Sessions at 1 month
11206055|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder Treatment Sessions at 1 Month|LSEG - Substance Use Disorder Treatment Sessions at 1 month
10813000|NCT00000134|FG002|Participant Flow|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10813001|NCT00000134|OG000|Outcome|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10813002|NCT00000134|OG001|Outcome|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
10813003|NCT00000134|OG002|Outcome|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10813004|NCT00000134|EG000|Reported Event|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10813005|NCT00000134|EG001|Reported Event|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
10821839|NCT00071812|EG002|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
11206056|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder Treatment Sessions at 3 Months|GMI - Substance Use Disorder Treatment Sessions at 3 months
10813006|NCT00000134|EG002|Reported Event|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
10813007|NCT00000135|BG000|Baseline|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813008|NCT00000135|BG001|Baseline|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813009|NCT00000135|BG002|Baseline|Total|Total of all reporting groups
10813010|NCT00000135|FG000|Participant Flow|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813011|NCT00000135|FG001|Participant Flow|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813012|NCT00000135|OG000|Outcome|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813013|NCT00000135|OG001|Outcome|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813014|NCT00000135|EG000|Reported Event|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813015|NCT00000135|EG001|Reported Event|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
10813016|NCT00000136|BG000|Baseline|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813017|NCT00000136|BG001|Baseline|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813018|NCT00000136|BG002|Baseline|Total|Total of all reporting groups
10813019|NCT00000136|FG000|Participant Flow|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813020|NCT00000136|FG001|Participant Flow|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813021|NCT00000136|OG000|Outcome|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813022|NCT00000136|OG001|Outcome|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813023|NCT00000136|EG000|Reported Event|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813024|NCT00000136|EG001|Reported Event|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
10813025|NCT00000142|BG000|Baseline|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813026|NCT00000142|BG001|Baseline|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813027|NCT00000142|BG002|Baseline|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813028|NCT00000142|BG003|Baseline|Total|Total of all reporting groups
10821840|NCT00071812|EG003|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
10821841|NCT00071812|EG004|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double blind period and opted to continue in the 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
10813029|NCT00000142|FG000|Participant Flow|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813030|NCT00000142|FG001|Participant Flow|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813031|NCT00000142|FG002|Participant Flow|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813032|NCT00000142|OG000|Outcome|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813033|NCT00000142|OG001|Outcome|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813034|NCT00000142|OG002|Outcome|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813035|NCT00000142|EG000|Reported Event|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813036|NCT00000142|EG001|Reported Event|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813037|NCT00000142|EG002|Reported Event|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
10813038|NCT00000143|BG000|Baseline|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
10813039|NCT00000143|BG001|Baseline|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
10967070|NCT00891176|FG003|Participant Flow|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
11206057|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder Treatment Sessions at 3 Months|LSEG - Substance Use Disorder Treatment Sessions at 3 months
10813040|NCT00000143|BG002|Baseline|Total|Total of all reporting groups
10821842|NCT00071890|BG000|Baseline|Interleukin-2 Group|HAART and tree cycles of IL-2
11206058|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder Treatment Sessions at 6 Months|GMI - Substance Use Disorder Treatment Sessions at 6 months
11206059|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder Treatment Sessions at 6 Months|LSEG - Substance Use Disorder Treatment Sessions at 6 months
11206060|NCT02233738|OG000|Outcome|GMI - Twelve-Step Sessions Attended at Baseline|GMI - Twelve-Step Sessions Attended at Baseline
10813041|NCT00000143|FG000|Participant Flow|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
10813042|NCT00000143|FG001|Participant Flow|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
11206061|NCT02233738|OG001|Outcome|LSEG - Twelve-Step Sessions Attended at Baseline|LSEG - Twelve-Step Sessions Attended at Baseline
11206062|NCT02233738|OG000|Outcome|GMI - Twelve-Step Sessions Attended at 1 Month|GMI - Twelve-Step Sessions Attended at 1 month
11206063|NCT02233738|OG001|Outcome|LSEG - Twelve-Step Sessions Attended at 1 Month|LSEG - Twelve-Step Sessions Attended at 1 month
11206064|NCT02233738|OG000|Outcome|GMI - Twelve-Step Sessions Attended at 3 Months|GMI - Twelve-Step Sessions Attended at 3 months
10813043|NCT00000143|OG000|Outcome|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
10813044|NCT00000143|OG001|Outcome|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
10813045|NCT00000143|EG000|Reported Event|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
10813046|NCT00000143|EG001|Reported Event|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
10813047|NCT00000371|BG000|Baseline|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
10813048|NCT00000371|BG001|Baseline|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
10813049|NCT00000371|BG002|Baseline|Total|Total of all reporting groups
10813050|NCT00000371|FG000|Participant Flow|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
10813051|NCT00000371|FG001|Participant Flow|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
10813052|NCT00000371|OG000|Outcome|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
10813053|NCT00000371|OG001|Outcome|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
10813054|NCT00000371|EG000|Reported Event|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
10813055|NCT00000371|EG001|Reported Event|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
10813056|NCT00000378|BG000|Baseline|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
11206065|NCT02233738|OG001|Outcome|LSEG - Twelve-Step Sessions Attended at 3 Months|LSEG - Twelve-Step Sessions Attended at 3 months
10813057|NCT00000378|BG001|Baseline|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
10813058|NCT00000378|BG002|Baseline|Total|Total of all reporting groups
10813059|NCT00000378|FG000|Participant Flow|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
11206066|NCT02233738|OG000|Outcome|GMI - Twelve-Step Sessions Attended at 6 Months|GMI - Twelve-Step Sessions Attended at 6 months
11206067|NCT02233738|OG001|Outcome|LSEG - Twelve-Step Sessions Attended at 6 Months|LSEG - Twelve-Step Sessions Attended at 6 months
11206068|NCT02233738|OG000|Outcome|GMI - Times Involved in Community Participation Activities at|GMI - Times Involved in Community Participation Activities at Baseline
11206069|NCT02233738|OG001|Outcome|LSEG - Times Involved in Community Participation Activities at|LSEG - Times Involved in Community Participation Activities at Baseline
11206070|NCT02233738|OG000|Outcome|GMI - Times Involved in Community Participation Activities at|GMI - Times Involved in Community Participation Activities at 1 month
11206071|NCT02233738|OG001|Outcome|LSEG - Times Involved in Community Participation Activities at|LSEG - Times Involved in Community Participation Activities at 1 month
11206072|NCT02233738|OG000|Outcome|GMI - Times Involved in Community Participation Activities at|GMI - Times Involved in Community Participation Activities at 3 months
11206073|NCT02233738|OG001|Outcome|LSEG - Times Involved in Community Participation Activities at|LSEG - Times Involved in Community Participation Activities at 3 months
11206074|NCT02233738|OG000|Outcome|GMI - Times Involved in Community Participation Activities at|GMI - Times Involved in Community Participation Activities at 6 months
11206075|NCT02233738|OG001|Outcome|LSEG - Times Involved in Community Participation Activities at|LSEG - Times Involved in Community Participation Activities at 6 months
11206076|NCT02233738|OG000|Outcome|GMI - Days Involved in Productive Work Activities at Baseline|GMI - Days Involved in Productive Work Activities at Baseline
11206077|NCT02233738|OG001|Outcome|LSEG - Days Involved in Productive Work Activities at Baseline|LSEG - Days Involved in Productive Work Activities at Baseline
11206078|NCT02233738|OG000|Outcome|GMI - Days Involved in Productive Work Activities at 1 Month|GMI - Days Involved in Productive Work Activities at 1 month
11206079|NCT02233738|OG001|Outcome|LSEG - Days Involved in Productive Work Activities at 1 Month|LSEG - Days Involved in Productive Work Activities at 1 month
11206080|NCT02233738|OG000|Outcome|GMI - Days Involved in Productive Work Activities at 3 Months|GMI - Days Involved in Productive Work Activities at 3 months
11206081|NCT02233738|OG001|Outcome|LSEG - Days Involved in Productive Work Activities at 3 Months|LSEG - Days Involved in Productive Work Activities at 3 months
11206082|NCT02233738|OG000|Outcome|GMI - Days Involved in Productive Work Activities at 6 Months|GMI - Days Involved in Productive Work Activities at 6 months
10813060|NCT00000378|FG001|Participant Flow|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
10813061|NCT00000378|OG000|Outcome|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
10813062|NCT00000378|OG001|Outcome|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
10813063|NCT00000378|EG000|Reported Event|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
10813064|NCT00000378|EG001|Reported Event|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
10813065|NCT00000392|BG000|Baseline|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
10813066|NCT00000392|BG001|Baseline|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
10813067|NCT00000392|BG002|Baseline|Total|Total of all reporting groups
10813068|NCT00000392|FG000|Participant Flow|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
10813069|NCT00000392|FG001|Participant Flow|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
10813070|NCT00000392|OG000|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
10813071|NCT00000392|OG001|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
10813072|NCT00000392|EG000|Reported Event|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
10813073|NCT00000392|EG001|Reported Event|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
10813074|NCT00000479|BG000|Baseline|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
10813075|NCT00000479|BG001|Baseline|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
10813076|NCT00000479|BG002|Baseline|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
10813077|NCT00000479|BG003|Baseline|Both Placebos|Placebo aspirin and placebo vitamin E
10813078|NCT00000479|BG004|Baseline|Total|Total of all reporting groups
10813079|NCT00000479|FG000|Participant Flow|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
10813080|NCT00000479|FG001|Participant Flow|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
10813081|NCT00000479|FG002|Participant Flow|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
10813082|NCT00000479|FG003|Participant Flow|Both Placebos|Placebo aspirin and placebo vitamin E
10813083|NCT00000479|OG000|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
10813084|NCT00000479|OG001|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
10813085|NCT00000479|OG002|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
10813086|NCT00000479|OG003|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
10813087|NCT00000479|EG000|Reported Event|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
10813088|NCT00000479|EG001|Reported Event|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
10813089|NCT00000479|EG002|Reported Event|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
10813090|NCT00000479|EG003|Reported Event|Both Placebos|Placebo aspirin and placebo vitamin E
10813091|NCT00000575|BG000|Baseline|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
10813092|NCT00000575|BG001|Baseline|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
10813093|NCT00000575|BG002|Baseline|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
10813094|NCT00000575|BG003|Baseline|Total|Total of all reporting groups
10813095|NCT00000575|FG000|Participant Flow|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
10813096|NCT00000575|FG001|Participant Flow|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
10813097|NCT00000575|FG002|Participant Flow|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
10813098|NCT00000575|OG000|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
10813099|NCT00000575|OG001|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
10813100|NCT00000575|OG002|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
10813101|NCT00000575|EG000|Reported Event|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
10813102|NCT00000575|EG001|Reported Event|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
10813103|NCT00000575|EG002|Reported Event|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
10813104|NCT00000620|BG000|Baseline|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10813105|NCT00000620|BG001|Baseline|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10813106|NCT00000620|BG002|Baseline|Total|Total of all reporting groups
10813107|NCT00000620|FG000|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
10813108|NCT00000620|FG001|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
10813109|NCT00000620|FG002|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
10813110|NCT00000620|FG003|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
10813111|NCT00000620|FG004|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
10813112|NCT00000620|FG005|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."
10813113|NCT00000620|FG006|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
10813114|NCT00000620|FG007|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
10813115|NCT00000620|OG000|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10821843|NCT00071890|BG001|Baseline|Control Group|HAART alone (without Interleukin-2)
10821844|NCT00071890|BG002|Baseline|Total|Total of all reporting groups
10813116|NCT00000620|OG001|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10813117|NCT00000620|OG000|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
10813118|NCT00000620|OG001|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
10813119|NCT00000620|OG000|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
10813120|NCT00000620|OG001|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
10813121|NCT00000620|OG000|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
10813122|NCT00000620|OG001|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
10813123|NCT00000620|EG000|Reported Event|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10813124|NCT00000620|EG001|Reported Event|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
10813125|NCT00001151|BG000|Baseline|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
10813126|NCT00001151|FG000|Participant Flow|Group 1|Patient has rickets (child) or osteomalacia (adult) of bone
10813127|NCT00001151|OG000|Outcome|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
10813128|NCT00001151|EG000|Reported Event|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
10813129|NCT00001213|BG000|Baseline|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
10813130|NCT00001213|FG000|Participant Flow|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
10813131|NCT00001213|OG000|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
10813132|NCT00001213|EG000|Reported Event|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
10813133|NCT00001262|BG000|Baseline|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
10813134|NCT00001262|BG001|Baseline|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
10813135|NCT00001262|BG002|Baseline|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
10813136|NCT00001262|BG003|Baseline|Total|Total of all reporting groups
10813137|NCT00001262|FG000|Participant Flow|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
10813138|NCT00001262|FG001|Participant Flow|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
10813139|NCT00001262|FG002|Participant Flow|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
10813140|NCT00001262|OG000|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
10813141|NCT00001262|OG001|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
10813142|NCT00001262|OG002|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
10813143|NCT00001262|EG000|Reported Event|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
10813144|NCT00001262|EG001|Reported Event|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
10813145|NCT00001262|EG002|Reported Event|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
10813146|NCT00001304|BG000|Baseline|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
10813147|NCT00001304|BG001|Baseline|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
10813148|NCT00001304|BG002|Baseline|Total|Total of all reporting groups
10813149|NCT00001304|FG000|Participant Flow|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
10813150|NCT00001304|FG001|Participant Flow|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
10813151|NCT00001304|OG000|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
10813152|NCT00001304|OG001|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
10813153|NCT00001304|EG000|Reported Event|PTH 1-34|"All patients received twice daily synthetic Human Parathyroid Hormone 1-34.~PTH 1-34"
10813154|NCT00001304|EG001|Reported Event|Calcitriol & Calcium|"All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.~Calcitriol & Calcium"
10813155|NCT00001305|BG000|Baseline|Growth Hormone|Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
10813156|NCT00001305|FG000|Participant Flow|Growth Hormone|Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
10813157|NCT00001305|OG000|Outcome|Growth Hormone|Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
10821845|NCT00071890|FG000|Participant Flow|Interleukin-2 Group|HAART and tree cycles of IL-2
11206083|NCT02233738|OG001|Outcome|LSEG - Days Involved in Productive Work Activities at 6 Months|LSEG - Days Involved in Productive Work Activities at 6 months
10821846|NCT00071890|FG001|Participant Flow|Control Group|HAART alone (without Interleukin-2)
11206084|NCT02233738|OG000|Outcome|GMI - Mental Health Treatment Sessions at Baseline|For those receiving GMI - Mental Health Treatment Sessions
11206085|NCT02233738|OG001|Outcome|LSEG - Mental Health Treatment Sessions at Baseline|For those receiving LSEG - Mental Health Treatment Sessions
11206086|NCT02233738|OG000|Outcome|GMI - Mental Health Treatment Sessions at 1 Month|For those receiving GMI - Mental Health Treatment Sessions at 1 Month
11206087|NCT02233738|OG001|Outcome|LSEG - Mental Health Treatment Sessions at 1 Month|For those receiving LSEG - Mental Health Treatment Sessions at 1 Month
11206088|NCT02233738|OG000|Outcome|GMI - Mental Health Treatment Sessions at 3 Months|For those receiving GMI - Mental Health Treatment Sessions at 3 Months
10813158|NCT00001305|EG000|Reported Event|Growth Hormone|Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
10813159|NCT00001566|BG000|Baseline|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
10813160|NCT00001566|FG000|Participant Flow|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
10813161|NCT00001566|OG000|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
10813162|NCT00001566|EG000|Reported Event|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
10813163|NCT00001575|BG000|Baseline|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
10813164|NCT00001575|FG000|Participant Flow|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
10813165|NCT00001575|OG000|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
10813166|NCT00001575|EG000|Reported Event|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
10813167|NCT00001586|BG000|Baseline|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
10813168|NCT00001586|BG001|Baseline|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
10813169|NCT00001586|BG002|Baseline|Total|Total of all reporting groups
10813170|NCT00001586|FG000|Participant Flow|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
10813171|NCT00001586|FG001|Participant Flow|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
10813172|NCT00001586|OG000|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
10813173|NCT00001586|OG001|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
10813174|NCT00001586|EG000|Reported Event|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
10813175|NCT00001586|EG001|Reported Event|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
10813176|NCT00001596|BG000|Baseline|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
10813177|NCT00001596|BG001|Baseline|Placebo|Subjects received placebo (3 pills), three times daily.
10813178|NCT00001596|BG002|Baseline|Total|Total of all reporting groups
10813179|NCT00001596|FG000|Participant Flow|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
10813180|NCT00001596|FG001|Participant Flow|Placebo|Subjects received placebo (3 pills), three times daily.
10813181|NCT00001596|OG000|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
10813182|NCT00001596|OG001|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
10813183|NCT00001596|EG000|Reported Event|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
10813184|NCT00001596|EG001|Reported Event|Placebo|Subjects received placebo (3 pills), three times daily.
10813185|NCT00001656|BG000|Baseline|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813186|NCT00001656|BG001|Baseline|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813187|NCT00001656|BG002|Baseline|Total|Total of all reporting groups
10813188|NCT00001656|FG000|Participant Flow|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813189|NCT00001656|FG001|Participant Flow|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813190|NCT00001656|OG000|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813191|NCT00001656|OG001|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813192|NCT00001656|EG000|Reported Event|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813193|NCT00001656|EG001|Reported Event|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
10813194|NCT00001703|BG000|Baseline|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
10813195|NCT00001703|FG000|Participant Flow|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
10813196|NCT00001703|OG000|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
10813197|NCT00001703|EG000|Reported Event|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
10813198|NCT00001723|BG000|Baseline|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10813199|NCT00001723|BG001|Baseline|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10813200|NCT00001723|BG002|Baseline|Total|Total of all reporting groups
10813201|NCT00001723|FG000|Participant Flow|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10813202|NCT00001723|FG001|Participant Flow|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10813203|NCT00001723|OG000|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10821847|NCT00071890|OG000|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
10813204|NCT00001723|OG001|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
10813205|NCT00001723|OG000|Outcome|Orlistat - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with orlistat
10813206|NCT00001723|OG001|Outcome|Orlistat - Non- Hispanic Whites|Change in weight for Non-Hispanic White participants treated with orlistat
10813207|NCT00001723|OG002|Outcome|Placebo - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with placebo
10813208|NCT00001723|OG003|Outcome|Placebo - Non-Hispanic Whites|Change in weight for Non-Hispanic White participants treated with placebo
10813209|NCT00001723|EG000|Reported Event|Orlistat|Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
10813210|NCT00001723|EG001|Reported Event|Placebo|Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
10813211|NCT00001832|BG000|Baseline|Cells IV + Cyclophosphamide 30mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
10813212|NCT00001832|BG001|Baseline|Cells IV + Cyclophosphamide 60mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
10813213|NCT00001832|BG002|Baseline|Cells IV + Low-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
10813214|NCT00001832|BG003|Baseline|Cells IV + High-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
11206089|NCT02233738|OG001|Outcome|LSEG - Mental Health Treatment Sessions at 3 Months|For those receiving LSEG - Mental Health Treatment Sessions at 3 Months
10813215|NCT00001832|BG004|Baseline|Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
10813216|NCT00001832|BG005|Baseline|Cells IA + MTD IL-2 (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
10813217|NCT00001832|BG006|Baseline|Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
10813218|NCT00001832|BG007|Baseline|Cells IA + MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813219|NCT00001832|BG008|Baseline|Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
10813220|NCT00001832|BG009|Baseline|Cells IV + MTD IL-2 no GCSF (gp100 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
10813221|NCT00001832|BG010|Baseline|Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813222|NCT00001832|BG011|Baseline|Cells IV + SQ IL-2 w/GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
10813223|NCT00001832|BG012|Baseline|Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813224|NCT00001832|BG013|Baseline|Cells IV + SQ IL-2 w/GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
10813225|NCT00001832|BG014|Baseline|Total|Total of all reporting groups
10813226|NCT00001832|FG000|Participant Flow|Abl Cells in Culture|Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
10813227|NCT00001832|FG001|Participant Flow|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
10813228|NCT00001832|FG002|Participant Flow|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
10813229|NCT00001832|FG003|Participant Flow|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
10821848|NCT00071890|OG001|Outcome|Control Group|HAART alone (without Interleukin-2)
11206090|NCT02233738|OG000|Outcome|GMI - Mental Health Treatment Sessions at 6 Months|For those receiving GMI - Mental Health Treatment Sessions at 6 Months
11206091|NCT02233738|OG001|Outcome|LSEG - Mental Health Treatment Sessions at 6 Months|For those receiving LSEG - Mental Health Treatment Sessions at 6 Months
11206092|NCT02233738|OG000|Outcome|GMI -Substance Use Disorder and Mental Health Treatment Sessio|For those receiving GMI - Substance Use Disorder and Mental Health Treatment Sessions at Baseline
11206093|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder and Mental Health Treatment Sess|For those receiving LSEG - Substance Use Disorder and Mental Health Treatment Sessions at Baseline
10813230|NCT00001832|FG004|Participant Flow|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
10813231|NCT00001832|FG005|Participant Flow|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
10813232|NCT00001832|FG006|Participant Flow|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
10813233|NCT00001832|FG007|Participant Flow|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
10813234|NCT00001832|FG008|Participant Flow|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813235|NCT00001832|FG009|Participant Flow|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
10813236|NCT00001832|FG010|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
10813237|NCT00001832|FG011|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813238|NCT00001832|FG012|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
10813239|NCT00001832|FG013|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813240|NCT00001832|FG014|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
10813241|NCT00001832|OG000|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
10813242|NCT00001832|OG001|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
10813243|NCT00001832|OG002|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
10813244|NCT00001832|OG003|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
10813245|NCT00001832|OG004|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
10813246|NCT00001832|OG005|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
10813247|NCT00001832|OG006|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
10813248|NCT00001832|OG007|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813249|NCT00001832|OG008|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
10813250|NCT00001832|OG009|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
10813251|NCT00001832|OG010|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813252|NCT00001832|OG011|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
10813253|NCT00001832|OG012|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813254|NCT00001832|OG013|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
10813255|NCT00001832|EG000|Reported Event|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
10813256|NCT00001832|EG001|Reported Event|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
10813257|NCT00001832|EG002|Reported Event|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
11206094|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder and Mental Health Treatment Sessi|For those receiving GMI - Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
10813258|NCT00001832|EG003|Reported Event|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
10813259|NCT00001832|EG004|Reported Event|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
10813260|NCT00001832|EG005|Reported Event|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
10813261|NCT00001832|EG006|Reported Event|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
10813262|NCT00001832|EG007|Reported Event|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813263|NCT00001832|EG008|Reported Event|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
10813264|NCT00001832|EG009|Reported Event|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
10813265|NCT00001832|EG010|Reported Event|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10813266|NCT00001832|EG011|Reported Event|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
10813267|NCT00001832|EG012|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
10821849|NCT00071890|EG000|Reported Event|Interleukin-2 Group|HAART and tree cycles of IL-2
10821850|NCT00071890|EG001|Reported Event|Control Group|HAART alone (without Interleukin-2)
11206095|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder and Mental Health Treatment Sess|For those receiving LSEG - Substance Use Disorder and Mental Health Treatment Sessions at 1 Month
11206096|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder and Mental Health Treatment Sessi|For those receiving GMI - Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
11206097|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder and Mental Health Treatment Sess|For those receiving LSEG - Substance Use Disorder and Mental Health Treatment Sessions at 3 Months
10813268|NCT00001832|EG013|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
10813269|NCT00001849|BG000|Baseline|Patients With Presumed Ectopic ACTH Secretion|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.~FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in positron emission tomography; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated.~Fluorine-18 (18F)-DOPA: 18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.~CT Scans, MRI scans"
10813270|NCT00001849|FG000|Participant Flow|Patients With Presumed Ectopic ACTH Secretion|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.~FDG-PET: Fluorodeoxyglucose (FDG) is a radiolabeled glucose used as a radiotracer in positron emission tomography (PET); FDG-PET was deleted as a required research study in 2004; thereafter used as clinically indicated.~Fluorine-18 dihydroxyphenylalanine (F-DOPA) is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.~CT Scans, MRI scans"
10813271|NCT00001849|OG000|Outcome|CT Scan Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~CT Scans of chest, abdomen, neck and/or pelvis are used."
10813272|NCT00001849|OG001|Outcome|Magnetic Resonance Imaging (MRI) Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~MRI scans of chest, abdomen, neck, head, and/or pelvis obtained at 1.5 Tesla are shown."
10813273|NCT00001849|OG002|Outcome|Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated."
10813274|NCT00001849|OG003|Outcome|[18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study."
10813275|NCT00001849|OG004|Outcome|Standard Dose Pentetreotide Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the standard dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study."
10813276|NCT00001849|OG005|Outcome|High Dose (18 mCi) Pentetreotide Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study."
10813277|NCT00001849|OG001|Outcome|MRI Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~MRI scans of chest, abdomen, neck, head, and/or pelvis obtained at 1.5 Tesla are shown."
10813278|NCT00001849|OG002|Outcome|FDG-PET Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in positron emission tomography; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated."
10813279|NCT00001849|OG003|Outcome|F-DOPA PET Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study."
10813280|NCT00001849|OG005|Outcome|High Dose (18 mCi) Octreotide Results|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study."
10813281|NCT00001849|EG000|Reported Event|Patients With Cushing Syndrome|"Patients receive various types of radiologic or nuclear medicine scans to identify tumor~Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.~18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. Limited to 3 doses over the course of the study.~CT scan: CT scan of chest, abdomen, neck and /or pelvis~MRI: MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis~18-FDG: FDG PET scan of body"
10813282|NCT00001880|BG000|Baseline|Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors|"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~methotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~cyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"
10813283|NCT00001880|FG000|Participant Flow|Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors|"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~methotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~cyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"
10813284|NCT00001880|OG000|Outcome|Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors|"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~methotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~cyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"
11206098|NCT02233738|OG000|Outcome|GMI - Substance Use Disorder and Mental Health Treatment Sessi|For those receiving GMI - Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
10813285|NCT00001880|EG000|Reported Event|Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors|"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~methotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given~cyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"
10813286|NCT00001941|BG000|Baseline|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813287|NCT00001941|FG000|Participant Flow|Phase I - 2 mg/kg Cohort|2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2
10813288|NCT00001941|FG001|Participant Flow|Phase I - 4 mg/kg Cohort|4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813289|NCT00001941|FG002|Participant Flow|Phase I - 6 mg/kg Cohort|6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813290|NCT00001941|FG003|Participant Flow|Phase I - 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813291|NCT00001941|FG004|Participant Flow|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813292|NCT00001941|OG000|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813293|NCT00001941|OG000|Outcome|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813294|NCT00001941|EG000|Reported Event|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
10813295|NCT00001959|BG000|Baseline|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
10813296|NCT00001959|FG000|Participant Flow|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
10813297|NCT00001959|OG000|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
10813298|NCT00001959|EG000|Reported Event|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
10813299|NCT00001962|BG000|Baseline|Daclizumab in Bone Marrow Failure Syndromes|Daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions in participants with a bone marrow failure syndrome. These subjects may be diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.
10813300|NCT00001962|FG000|Participant Flow|Daclizumab in Bone Marrow Failure Syndromes|Daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions in participants with a bone marrow failure syndrome. These subjects may be diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.
10813301|NCT00001962|OG000|Outcome|Daclizumab in Participants With a Bone Marrow Failure Syndrome|Daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions in participants with a bone marrow failure syndrome. These subjects may be diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.
10813302|NCT00001962|EG000|Reported Event|Daclizumab in Participants With a Bone Marrow Failure Syndrome|Daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions in participants with a bone marrow failure syndrome. These subjects may be diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.
10813303|NCT00001984|BG000|Baseline|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
10813304|NCT00001984|FG000|Participant Flow|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
10813305|NCT00001984|OG000|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
10813306|NCT00001984|EG000|Reported Event|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
10813307|NCT00002525|BG000|Baseline|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813308|NCT00002525|BG001|Baseline|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813309|NCT00002525|BG002|Baseline|Total|Total of all reporting groups
10813310|NCT00002525|FG000|Participant Flow|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813311|NCT00002525|FG001|Participant Flow|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813312|NCT00002525|OG000|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813313|NCT00002525|OG001|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813314|NCT00002525|EG000|Reported Event|Arm I (Perioperative 5-FU)|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813315|NCT00002525|EG001|Reported Event|Arm II (No Perioperative 5-FU)|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
10813316|NCT00002525|EG002|Reported Event|Adjuvant Chemotherapy-- 5-FU+Levamisolem|"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:~Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin~A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
10813317|NCT00002525|EG003|Reported Event|Adjuvant Chemotherapy-- 5-FU+Leucovovin|"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:~Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.~5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
11206099|NCT02233738|OG001|Outcome|LSEG - Substance Use Disorder and Mental Health Treatment Sess|For those receiving LSEG - Substance Use Disorder and Mental Health Treatment Sessions at 6 Months
10813327|NCT00002558|BG000|Baseline|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
10813328|NCT00002558|BG001|Baseline|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
10813329|NCT00002558|BG002|Baseline|Total|Total of all reporting groups
10813330|NCT00002558|FG000|Participant Flow|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
10813331|NCT00002558|FG001|Participant Flow|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
10813332|NCT00002558|OG000|Outcome|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
10813333|NCT00002558|OG001|Outcome|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
10813334|NCT00002558|EG000|Reported Event|Group A: <= 6 Cycles of Cisplatin|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
10813335|NCT00002558|EG001|Reported Event|Group: B > 6 Cycles of Cisplatin|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
10813336|NCT00002597|BG000|Baseline|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
10813337|NCT00002597|BG001|Baseline|Radiation Therapy Alone|Radiation therapy alone
10813338|NCT00002597|BG002|Baseline|Total|Total of all reporting groups
10813339|NCT00002597|FG000|Participant Flow|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
10813340|NCT00002597|FG001|Participant Flow|Radiation Therapy Alone|Radiation therapy alone
10813341|NCT00002597|OG000|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
10813342|NCT00002597|OG001|Outcome|Radiation Therapy Alone|Radiation therapy alone
10813343|NCT00002597|EG000|Reported Event|Neoadjuvant TAS 2 Months Before and During RT|Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
10813344|NCT00002597|EG001|Reported Event|Radiation Therapy Alone|Radiation therapy alone
10813345|NCT00002601|BG000|Baseline|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
10813346|NCT00002601|FG000|Participant Flow|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
10813347|NCT00002601|OG000|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
10813348|NCT00002601|OG000|Outcome|Cycle 1|Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
10813349|NCT00002601|OG001|Outcome|Cycle 2|Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
10813350|NCT00002601|EG000|Reported Event|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
10813351|NCT00002651|BG000|Baseline|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
10813352|NCT00002651|BG001|Baseline|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
10813353|NCT00002651|BG002|Baseline|Total|Total of all reporting groups
10813354|NCT00002651|FG000|Participant Flow|Combined Androgen Deprivation (CAD)|Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months.
10813355|NCT00002651|FG001|Participant Flow|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
10821851|NCT00071981|BG000|Baseline|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
10813356|NCT00002651|FG002|Participant Flow|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
10813357|NCT00002651|OG000|Outcome|Consolidation Arm I|"Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously"
10813358|NCT00002651|OG001|Outcome|Consolidation Arm II|"Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously~clinical observation: Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease."
10813359|NCT00002651|OG000|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
10813360|NCT00002651|OG001|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
10813361|NCT00002651|EG000|Reported Event|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
10813362|NCT00002651|EG001|Reported Event|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
10813363|NCT00002766|BG000|Baseline|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
10813364|NCT00002766|BG001|Baseline|L-20|"Standard Vincristine/Prednisone (L-20)"
10813365|NCT00002766|BG002|Baseline|Total|Total of all reporting groups
10813366|NCT00002766|FG000|Participant Flow|All-2|"ARA-C/High-Dose Mitoxantrone(All-2) Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover."
10813367|NCT00002766|FG001|Participant Flow|L-20|"Standard Vincristine/Prednisone (L-20) Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover."
10813368|NCT00002766|OG000|Outcome|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
10813369|NCT00002766|OG001|Outcome|L-20|"Standard Vincristine/Prednisone (L-20)"
10813370|NCT00002766|EG000|Reported Event|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
10813371|NCT00002766|EG001|Reported Event|L-20|"Standard Vincristine/Prednisone (L-20)"
10813372|NCT00002842|BG000|Baseline|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
10813373|NCT00002842|FG000|Participant Flow|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
10813374|NCT00002842|OG000|Outcome|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
10813375|NCT00002842|EG000|Reported Event|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
10813376|NCT00002850|BG000|Baseline|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
10813377|NCT00002850|BG001|Baseline|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
10813378|NCT00002850|BG002|Baseline|Observation|No prophylaxis: The patient will receive no prophylactic antibiotics.
10813379|NCT00002850|BG003|Baseline|Total|Total of all reporting groups
10813380|NCT00002850|FG000|Participant Flow|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
10813381|NCT00002850|FG001|Participant Flow|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
10813382|NCT00002850|FG002|Participant Flow|Observation|Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
11244331|NCT02510001|OG002|Outcome|Dose Escalation Phase Dose 3.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle
10813383|NCT00002850|OG000|Outcome|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
10813384|NCT00002850|OG001|Outcome|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
10813385|NCT00002850|OG002|Outcome|No Prophylaxis|The patient will receive no prophylactic antibiotics.
10813386|NCT00002850|EG000|Reported Event|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
10813387|NCT00002850|EG001|Reported Event|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
10813388|NCT00002850|EG002|Reported Event|Observation|No Prophylaxis: The patient will receive no prophylactic antibiotics.
10821852|NCT00071981|BG001|Baseline|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
10821853|NCT00071981|BG002|Baseline|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
11244332|NCT02510001|OG003|Outcome|Dose Escalation Phase Dose 4.|Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
11244333|NCT02510001|OG000|Outcome|Dose Expansion Phase|All of the patients registered for this expansion phase are included in this survival analysis, to preliminarily assess the efficacy of the drug combination.
11244334|NCT02510001|OG000|Outcome|Dose Escalation Phase 5.|Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
11244335|NCT02510001|OG001|Outcome|Dose Escalation Phase Dose 5a|Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. Crizotinib (PF-02341066) 250mg OD continuous administration
11244336|NCT02510001|OG002|Outcome|Dose Escalation Phase Dose 5 (Interval Dosing)|Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
11244337|NCT02510001|OG004|Outcome|Dose Escalation Phase 5.|Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
11244338|NCT02510001|OG005|Outcome|Dose Escalation Phase Dose 5a|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10813389|NCT03666988|BG000|Baseline|Part 1 GSK3368715 50mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
10813390|NCT03666988|BG001|Baseline|Part 1 GSK3368715 100mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
10813391|NCT03666988|BG002|Baseline|Part 1 GSK3368715 200mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
10813392|NCT03666988|BG003|Baseline|Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813393|NCT03666988|BG004|Baseline|Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
10813394|NCT03666988|BG005|Baseline|Part 2 GSK3368715 Expansion Cohort|Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
10813395|NCT03666988|BG006|Baseline|Total|Total of all reporting groups
10813396|NCT03666988|FG000|Participant Flow|Part 1 GSK3368715 50mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
10813397|NCT03666988|FG001|Participant Flow|Part 1 GSK3368715 100mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
11206100|NCT02233738|OG000|Outcome|GMI - Addiction Severity Index-Lite (ASI-Lite) at Baseline for|GMI - Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
11206101|NCT02233738|OG001|Outcome|LSEG - Addiction Severity Index-Lite (ASI-Lite) at Baseline fo|LSEG - Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
10813398|NCT03666988|FG002|Participant Flow|Part 1 GSK3368715 200mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
10813399|NCT03666988|FG003|Participant Flow|Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813400|NCT03666988|FG004|Participant Flow|Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
10813401|NCT03666988|FG005|Participant Flow|Part 2 GSK3368715 Expansion Cohort|Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
10813402|NCT03666988|OG000|Outcome|Part 1 GSK3368715 50mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
10813403|NCT03666988|OG001|Outcome|Part 1 GSK3368715 100mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
10813404|NCT03666988|OG002|Outcome|Part 1 GSK3368715 200mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
10813405|NCT03666988|OG003|Outcome|Part 1: Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813406|NCT03666988|OG004|Outcome|Part 1: Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
10813407|NCT03666988|OG003|Outcome|Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813408|NCT03666988|OG004|Outcome|Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
10813409|NCT03666988|OG000|Outcome|Part 2 GSK3368715 Expansion Cohort|Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
10813410|NCT03666988|OG000|Outcome|Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813411|NCT03666988|OG001|Outcome|Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
10813412|NCT03666988|EG000|Reported Event|Part 1 GSK3368715 50mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
10813413|NCT03666988|EG001|Reported Event|Part 1 GSK3368715 100mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
11206102|NCT02233738|OG000|Outcome|GMI - ASI -- 1 Month Composite Score for Alcohol Use|GMI - ASI -- 1 month Composite Score for Alcohol Use
11206103|NCT02233738|OG001|Outcome|LSEG - ASI -- 1 Month Composite Score for Alcohol Use|LSEG - ASI -- 1 month Composite Score for Alcohol Use
11206104|NCT02233738|OG000|Outcome|GMI - ASI -- 3 Months Composite Score for Alcohol Use|GMI - ASI -- 3 months Composite Score for Alcohol Use
11206105|NCT02233738|OG001|Outcome|LSEG - ASI -- 3 Months Composite Score for Alcohol Use|LSEG - ASI -- 3 months Composite Score for Alcohol Use
11206106|NCT02233738|OG000|Outcome|GMI - ASI -- 6 Months Composite Score for Alcohol Use|GMI - ASI -- 6 months Composite Score for Alcohol Use
11206107|NCT02233738|OG001|Outcome|LSEG - ASI -- 6 Months Composite Score for Alcohol Use|LSEG - ASI -- 6 months Composite Score for Alcohol Use
11206108|NCT02233738|OG000|Outcome|GMI - Addiction Severity Index-Lite (ASI-Lite) at Baseline for|GMI - Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
10813414|NCT03666988|EG002|Reported Event|Part 1 GSK3368715 200mg|Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
10813415|NCT03666988|EG003|Reported Event|Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
10813416|NCT03666988|EG004|Reported Event|Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted|Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
10813417|NCT03666988|EG005|Reported Event|Part 2 GSK3368715 Expansion Cohort|Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
10813418|NCT03552029|BG000|Baseline|Part 1, Cohort 1: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
10813419|NCT03552029|BG001|Baseline|Part 1, Cohort 1A: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
10813420|NCT03552029|BG002|Baseline|Total|Total of all reporting groups
10813421|NCT03552029|FG000|Participant Flow|Part 1, Cohort 1: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
10813422|NCT03552029|FG001|Participant Flow|Part 1, Cohort 1A: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
10813423|NCT03552029|OG000|Outcome|Part 1, Cohort 1: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
10813424|NCT03552029|OG001|Outcome|Part 1, Cohort 1A: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
10813425|NCT03552029|EG000|Reported Event|Part 1, Cohort 1: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
10813426|NCT03552029|EG001|Reported Event|Part 1, Cohort 1A: Quizartinib + Milademetan|Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
10813427|NCT03549104|BG000|Baseline|Fear Reduction Efficacy Evaluation (FREE)|"The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.~Fear Reduction Intervention: FREE"
10813428|NCT03549104|BG001|Baseline|Attention Control|"The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.~Attention Control: DSMES"
10813429|NCT03549104|BG002|Baseline|Total|Total of all reporting groups
10813430|NCT03549104|FG000|Participant Flow|Fear Reduction Efficacy Evaluation (FREE)|"The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.~Fear Reduction Intervention: FREE"
10813431|NCT03549104|FG001|Participant Flow|Attention Control|"The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.~Attention Control: DSMES"
10813432|NCT03549104|OG000|Outcome|Fear Reduction Efficacy Evaluation (FREE)|"The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.~Fear Reduction Intervention: FREE"
10813433|NCT03549104|OG001|Outcome|Attention Control|"The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.~Attention Control: DSMES"
10813434|NCT03549104|EG000|Reported Event|Fear Reduction Efficacy Evaluation (FREE)|"The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.~Fear Reduction Intervention: FREE"
10813435|NCT03549104|EG001|Reported Event|Attention Control|"The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.~Attention Control: DSMES"
10813436|NCT03462719|BG000|Baseline|Treatment Arm A (Ibrutinib + Venetoclax)|Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813437|NCT03462719|BG001|Baseline|Treatment Arm B (Chlorambucil + Obinutuzumab)|Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mg intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813438|NCT03462719|BG002|Baseline|Total|Total of all reporting groups
10813439|NCT03462719|FG000|Participant Flow|Treatment Arm A (Ibrutinib + Venetoclax)|Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10821854|NCT00071981|BG003|Baseline|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821855|NCT00071981|BG004|Baseline|Total|Total of all reporting groups
11206109|NCT02233738|OG001|Outcome|LSEG - Addiction Severity Index-Lite (ASI-Lite) at Baseline fo|LSEG - Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
11206110|NCT02233738|OG000|Outcome|GMI - Addiction Severity Index-Lite (ASI-Lite) at 1 Month for|GMI - Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status
11206111|NCT02233738|OG001|Outcome|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 1 Month for|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status
11206112|NCT02233738|OG000|Outcome|GMI - Addiction Severity Index-Lite (ASI-Lite) at 3 Months for|GMI - Addiction Severity Index-Lite (ASI-Lite) at 3 months for Psychiatric Status
10813440|NCT03462719|FG001|Participant Flow|Treatment Arm B (Chlorambucil + Obinutuzumab)|Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mg intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813441|NCT03462719|OG000|Outcome|Treatment Arm A (Ibrutinib + Venetoclax)|Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813442|NCT03462719|OG001|Outcome|Treatment Arm B (Chlorambucil + Obinutuzumab)|Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mg intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813443|NCT03462719|EG000|Reported Event|Treatment Arm A (Ibrutinib + Venetoclax)|Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813444|NCT03462719|EG001|Reported Event|Treatment Arm B (Chlorambucil + Obinutuzumab)|Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mg intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and receive single-agent ibrutinib until disease progression or unacceptable toxicity.
10813445|NCT03332589|BG000|Baseline|Monotherapy Safety Run-in: E6201|"E6201 320 mg/m^2 administered IV over 2 hours twice weekly on Days 1, 4, 8, 11, 15 and 18, repeated every 28 days (=1 cycle).~Dose reductions for toxicity are 240 mg/m^2 (Dose Level -1) and 160 mg/m^2 (Dose Level -2) twice weekly.~E6201: E6201 for Injection formulated in cyclodextrin for IV administration"
10813446|NCT03332589|BG001|Baseline|Combination Safety Run-in: E6201 Plus Dabrafenib|"Dose Level 1: E6201 320 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -1: E6201 240 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -2: E6201 240 mg/m^2 twice weekly plus dabrafenib 100 mg BID. Dose Level -3: E6201 160 mg/m^2 twice weekly plus dabrafenib 100 mg BID Dose Level -4: E6201 160 mg/m^2 twice weekly plus dabrafenib 75 mg BID. Dose Level -5: E6201 160 mg/m^2 twice weekly plus dabrafenib 50 mg BID.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813447|NCT03332589|BG002|Baseline|Expansion: E6201 Plus Dabrafenib|"A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813448|NCT03332589|BG003|Baseline|Total|Total of all reporting groups
10813449|NCT03332589|FG000|Participant Flow|Monotherapy Safety Run-in: E6201|"E6201 320 mg/m^2 administered IV over 2 hours twice weekly on Days 1, 4, 8, 11, 15 and 18, repeated every 28 days (=1 cycle).~Dose reductions for toxicity are 240 mg/m^2 (Dose Level -1) and 160 mg/m^2 (Dose Level -2) twice weekly.~E6201: E6201 for Injection formulated in cyclodextrin for IV administration"
10813450|NCT03332589|FG001|Participant Flow|Combination Safety Run-in: E6201 Plus Dabrafenib|"Dose Level 1: E6201 320 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -1: E6201 240 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -2: E6201 240 mg/m^2 twice weekly plus dabrafenib 100 mg BID. Dose Level -3: E6201 160 mg/m^2 twice weekly plus dabrafenib 100 mg BID Dose Level -4: E6201 160 mg/m^2 twice weekly plus dabrafenib 75 mg BID. Dose Level -5: E6201 160 mg/m^2 twice weekly plus dabrafenib 50 mg BID.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813451|NCT03332589|FG002|Participant Flow|Expansion: E6201 Plus Dabrafenib|"A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813452|NCT03332589|OG000|Outcome|Monotherapy Safety Run-in: E6201|"E6201 320 mg/m^2 administered IV over 2 hours twice weekly on Days 1, 4, 8, 11, 15 and 18, repeated every 28 days (=1 cycle).~Dose reductions for toxicity are 240 mg/m^2 (Dose Level -1) and 160 mg/m^2 (Dose Level -2) twice weekly.~E6201: E6201 for Injection formulated in cyclodextrin for IV administration"
10813453|NCT03332589|OG001|Outcome|Combination Safety Run-in: E6201 Plus Dabrafenib|"Dose Level 1: E6201 320 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -1: E6201 240 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -2: E6201 240 mg/m^2 twice weekly plus dabrafenib 100 mg BID. Dose Level -3: E6201 160 mg/m^2 twice weekly plus dabrafenib 100 mg BID Dose Level -4: E6201 160 mg/m^2 twice weekly plus dabrafenib 75 mg BID. Dose Level -5: E6201 160 mg/m^2 twice weekly plus dabrafenib 50 mg BID.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813454|NCT03332589|OG002|Outcome|Expansion: E6201 Plus Dabrafenib|"A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813455|NCT03332589|EG000|Reported Event|Monotherapy Safety Run-in: E6201|"E6201 320 mg/m^2 administered IV over 2 hours twice weekly on Days 1, 4, 8, 11, 15 and 18, repeated every 28 days (=1 cycle).~Dose reductions for toxicity are 240 mg/m^2 (Dose Level -1) and 160 mg/m^2 (Dose Level -2) twice weekly.~E6201: E6201 for Injection formulated in cyclodextrin for IV administration"
11206113|NCT02233738|OG001|Outcome|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 3 Month for|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 3 months for Psychiatric Status
11206114|NCT02233738|OG000|Outcome|GMI - Addiction Severity Index-Lite (ASI-Lite) at 6 Months for|GMI - Addiction Severity Index-Lite (ASI-Lite) at 6 months for Psychiatric Status
11206115|NCT02233738|OG001|Outcome|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 6 Months fo|LSEG - Addiction Severity Index-Lite (ASI-Lite) at 6 months for Psychiatric Status
11206116|NCT02233738|OG000|Outcome|GMI - Short Inventory of Problems at Baseline - Total Score|GMI - Short Inventory of Problems Revised (SIP-R) at Baseline
11206117|NCT02233738|OG001|Outcome|LSEG - Short Inventory of Problems Revised (SIP-R) at Baseline|LSEG - Short Inventory of Problems Revised (SIP-R) at Baseline
11206118|NCT02233738|OG000|Outcome|GMI - Short Inventory of Problems Revised (SIP-R) at 1 Month|GMI - Short Inventory of Problems Revised (SIP-R) at 1 month
11206119|NCT02233738|OG001|Outcome|LSEG - Short Inventory of Problems Revised (SIP-R) at 1 Month|LSEG - Short Inventory of Problems Revised (SIP-R) at 1 month
11206120|NCT02233738|OG000|Outcome|GMI - Short Inventory of Problems Revised (SIP-R) at 3 Months|GMI - Short Inventory of Problems Revised (SIP-R) at 3 months
11206121|NCT02233738|OG001|Outcome|LSEG - Short Inventory of Problems Revised (SIP-R) at 3 Months|LSEG - Short Inventory of Problems Revised (SIP-R) at 3 months
11206122|NCT02233738|OG000|Outcome|GMI - Short Inventory of Problems Revised (SIP-R) at 6 Months|GMI - Short Inventory of Problems Revised (SIP-R) at 6 months
11206123|NCT02233738|OG001|Outcome|LSEG - Short Inventory of Problems Revised (SIP-R) at 6 Months|LSEG - Short Inventory of Problems Revised (SIP-R) at 6 months
10813456|NCT03332589|EG001|Reported Event|Combination Safety Run-in: E6201 Plus Dabrafenib|"Dose Level 1: E6201 320 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -1: E6201 240 mg/m^2 twice weekly plus dabrafenib 150 mg BID. Dose Level -2: E6201 240 mg/m^2 twice weekly plus dabrafenib 100 mg BID. Dose Level -3: E6201 160 mg/m^2 twice weekly plus dabrafenib 100 mg BID Dose Level -4: E6201 160 mg/m^2 twice weekly plus dabrafenib 75 mg BID. Dose Level -5: E6201 160 mg/m^2 twice weekly plus dabrafenib 50 mg BID.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10813457|NCT03332589|EG002|Reported Event|Expansion: E6201 Plus Dabrafenib|"A total of up to N=18 will be treated at the E6201 plus dabrafenib combined MTD.~E6201 plus dabrafenib: E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules"
10821856|NCT00071981|FG000|Participant Flow|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
10821857|NCT00071981|FG001|Participant Flow|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
10821858|NCT00071981|FG002|Participant Flow|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821859|NCT00071981|FG003|Participant Flow|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821860|NCT00071981|OG000|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
10821861|NCT00071981|OG001|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
10821862|NCT00071981|OG002|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821863|NCT00071981|OG003|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821864|NCT00071981|EG000|Reported Event|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
10821865|NCT00071981|EG001|Reported Event|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
10821866|NCT00071981|EG002|Reported Event|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10821867|NCT00071981|EG003|Reported Event|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
10813458|NCT03091192|BG000|Baseline|Savolitinib QD|Savolitinib QD
10813459|NCT03091192|BG001|Baseline|Sunitinib QD|Sunitinib QD
10813460|NCT03091192|BG002|Baseline|Total|Total of all reporting groups
10813461|NCT03091192|FG000|Participant Flow|Savolitinib QD|Savolitinib QD
10813462|NCT03091192|FG001|Participant Flow|Sunitinib QD|Sunitinib QD
10813463|NCT03091192|OG000|Outcome|Savolitinib QD|Savolitinib QD
10813464|NCT03091192|OG001|Outcome|Sunitinib QD|Sunitinib QD
10813465|NCT03091192|EG000|Reported Event|Savolitinib QD|Savolitinib QD
10813466|NCT03091192|EG001|Reported Event|Sunitinib QD|Sunitinib QD
10813467|NCT02717611|BG000|Baseline|Acalabrutinib|Acalabrutinib 100 mg BID
10813468|NCT02717611|FG000|Participant Flow|Acalabrutinib|Acalabrutinib 100 mg BID
10813469|NCT02717611|OG000|Outcome|Acalabrutinib|Acalabrutinib 100 mg BID
10813470|NCT02717611|EG000|Reported Event|Acalabrutinib|Acalabrutinib 100 mg BID
10813471|NCT02301156|BG000|Baseline|Ublituximab + Ibrutinib|Participants received ublituximab IV infusion, up to 150 mg once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 54.6 months along with ibrutinib 420 mg capsules, orally, QD in each 28-day cycle for up to 51.6 months.
10813472|NCT02301156|BG001|Baseline|Ibrutinib|Participants received ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 56.3 months.
10813473|NCT02301156|BG002|Baseline|Total|Total of all reporting groups
10813474|NCT02301156|FG000|Participant Flow|Ublituximab + Ibrutinib|Participants received ublituximab intravenous (IV) infusion, up to 150 milligrams (mg) once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 54.6 months along with ibrutinib 420 mg capsules, orally, once daily (QD) in each 28-day cycle for up to 51.6 months.
10813475|NCT02301156|FG001|Participant Flow|Ibrutinib|Participants received ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 56.3 months.
10813476|NCT02301156|OG000|Outcome|Ublituximab + Ibrutinib|Participants received ublituximab IV infusion, up to 150 mg once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 54.6 months along with ibrutinib 420 mg capsules, orally, QD in each 28-day cycle for up to 51.6 months.
10813477|NCT02301156|OG001|Outcome|Ibrutinib|Participants received ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 56.3 months.
10813478|NCT02301156|EG000|Reported Event|Ublituximab + Ibrutinib|Participants received ublituximab IV infusion, up to 150 mg once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 54.6 months along with ibrutinib 420 mg capsules, orally, QD in each 28-day cycle for up to 51.6 months.
10813479|NCT02301156|EG001|Reported Event|Ibrutinib|Participants received ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 56.3 months.
10813480|NCT02296125|BG000|Baseline|Global + China Extension Osimertinib Arm|All participants who were enrolled in Osimertinib Arm for either the global or China Extension study.
10813481|NCT02296125|BG001|Baseline|Global + China Extension SoC EGFR-TKI Arm|All participants who were enrolled in SoC EGFR-TKI Arm for either the Global or China Extension study
10813482|NCT02296125|BG002|Baseline|Total|Total of all reporting groups
10813483|NCT02296125|FG000|Participant Flow|Osimertinib 80 mg (Global Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813484|NCT02296125|FG001|Participant Flow|SoC EGFR-TKI (Global Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813485|NCT02296125|FG002|Participant Flow|Osimertinib 80 mg (China Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813486|NCT02296125|FG003|Participant Flow|SoC EGFR-TKI (China Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813487|NCT02296125|OG000|Outcome|Osimertinib 80 mg (Global Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813488|NCT02296125|OG001|Outcome|SoC EGFR-TKI (Global Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813489|NCT02296125|OG002|Outcome|Osimertinib 80 mg (China Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813490|NCT02296125|OG003|Outcome|SoC EGFR-TKI (China Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813491|NCT02296125|OG001|Outcome|Osimertinib 80 mg (China Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813492|NCT02296125|EG000|Reported Event|Osimertinib 80 mg (Global Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813493|NCT02296125|EG001|Reported Event|SoC EGFR-TKI (Global Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813494|NCT02296125|EG002|Reported Event|Osimertinib 80 mg (China Cohort)|Randomized participants received Osimertinib 80 mg orally once daily (QD)
10813495|NCT02296125|EG003|Reported Event|SoC EGFR-TKI (China Cohort)|Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
10813496|NCT02087423|BG000|Baseline|Cohort 1 (EGFR/ALK+)|Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
11206124|NCT02233738|OG000|Outcome|GMI - Social Support Survey Total Score at Baseline|GMI - Social Support Survey Total Score at Baseline
10813497|NCT02087423|BG001|Baseline|Cohort 2|Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813498|NCT02087423|BG002|Baseline|Cohort 3 (TC >= 90%)|Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
10813499|NCT02087423|BG003|Baseline|Total|Total of all reporting groups
10813500|NCT02087423|FG000|Participant Flow|Cohort 1 (EGFR/ALK+)|Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813501|NCT02087423|FG001|Participant Flow|Cohort 2|Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813502|NCT02087423|FG002|Participant Flow|Cohort 3 (TC >= 90%)|Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
10813503|NCT02087423|OG000|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)|Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.
10813504|NCT02087423|OG001|Outcome|Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)|Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813505|NCT02087423|OG002|Outcome|Cohort 2 PD-L1+ (>=25%)|Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.
10813506|NCT02087423|OG003|Outcome|Cohort 2 PD-L1+ (<25%)|Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813507|NCT02087423|OG004|Outcome|Cohort 3 (TC>=90%)|Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
10813508|NCT02087423|EG000|Reported Event|Cohort 1 (EGFR/ALK+)|Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813509|NCT02087423|EG001|Reported Event|Cohort 2|Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.
10813510|NCT02087423|EG002|Reported Event|Cohort 3 (TC >=90%)|Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
10813511|NCT01946204|BG000|Baseline|Placebo|Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813512|NCT01946204|BG001|Baseline|Apalutamide|Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813513|NCT01946204|BG002|Baseline|Total|Total of all reporting groups
10813514|NCT01946204|FG000|Participant Flow|Placebo|Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813515|NCT01946204|FG001|Participant Flow|Apalutamide|Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813516|NCT01946204|OG000|Outcome|Placebo|Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813517|NCT01946204|OG001|Outcome|Apalutamide|Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813518|NCT01946204|EG000|Reported Event|Placebo|Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813519|NCT01946204|EG001|Reported Event|Apalutamide|Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
10813520|NCT01626079|BG000|Baseline|MitraClip System|"Percutaneous mitral valve repair using MitraClip System~MitraClip System: Percutaneous mitral valve repair using MitraClip System"
10813521|NCT01626079|BG001|Baseline|Control Group|Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
10813522|NCT01626079|BG002|Baseline|COAPT CAS Group|subjects who received Percutaneous mitral valve repair using MitraClip System in the COAPT continued access study (CAS) group.
10813523|NCT01626079|BG003|Baseline|Total|Total of all reporting groups
10813524|NCT01626079|FG000|Participant Flow|MitraClip System|"Percutaneous mitral valve repair using MitraClip System~MitraClip System: Percutaneous mitral valve repair using MitraClip System"
10813525|NCT01626079|FG001|Participant Flow|Control Group|Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
10813526|NCT01626079|FG002|Participant Flow|COAPT CAS Group|"162 Subjects enrolled in the COAPT Continued access study (CAS) group.~Subject follow-up until occurred until 12-month visit."
10813527|NCT01626079|OG000|Outcome|MitraClip System|"Percutaneous mitral valve repair using MitraClip System~MitraClip System: Percutaneous mitral valve repair using MitraClip System"
10813528|NCT01626079|OG001|Outcome|Control Group|Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
10813529|NCT01626079|OG000|Outcome|Randomized Group|Randomized group contains both Device and Control Group
10813530|NCT01626079|OG000|Outcome|Device Group|MitraClip Device
10813531|NCT01626079|OG001|Outcome|Control Group|Control group treated with medication
10813532|NCT01626079|OG000|Outcome|Device Group|MitraClip device
10813533|NCT01626079|EG000|Reported Event|MitraClip System|"Percutaneous mitral valve repair using MitraClip System~MitraClip System: Percutaneous mitral valve repair using MitraClip System"
10813534|NCT01626079|EG001|Reported Event|Control Group|Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
10813535|NCT01626079|EG002|Reported Event|COAPT CAS Group|subjects enrolled as part of the Continued Access Study with Percutaneous mitral valve repair using MitraClip System
10813536|NCT01612351|BG000|Baseline|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813537|NCT01612351|FG000|Participant Flow|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813538|NCT01612351|OG000|Outcome|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813539|NCT01612351|OG000|Outcome|Pre-treatment|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813540|NCT01612351|OG001|Outcome|Post-Induction|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813541|NCT01612351|OG002|Outcome|1 Year Post Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
10813542|NCT01612351|OG000|Outcome|Non-Randomized Single-Arm|All participants will receive induction chemotherapy and response evaluation was completed.
10813543|NCT01612351|OG000|Outcome|Induction Chemotherapy Followed by Transoral Surgery|All participants received LCCC1125 study treatment and co-enrolled with o-enrollment with the LCCC0121 study.
10813544|NCT01612351|EG000|Reported Event|Induction Chemotherapy Followed by Transoral Surgery|All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.
11206125|NCT02233738|OG001|Outcome|LSEG - Social Support Survey Total Score at Baseline|LSEG - Social Support Survey Total Score at Baseline
11206126|NCT02233738|OG000|Outcome|GMI - Social Support Survey Total Score at 1-month Follow-up|GMI - Social Support Survey Total Score at 1-month follow-up
11206127|NCT02233738|OG001|Outcome|LSEG - Social Support Survey Total Score at 1-month Follow-up|LSEG - Social Support Survey Total Score at 1-month follow-up
11206128|NCT02233738|OG000|Outcome|GMI - Social Support Survey Total Score at 3 Months|GMI - Social Support Survey Total Score at 3 months
11206129|NCT02233738|OG001|Outcome|LSEG - Social Support Survey Total Score at 3 Months|LSEG - Social Support Survey Total Score at 3 months
11206130|NCT02233738|OG000|Outcome|GMI - Social Support Survey Total Score at 6 Months|GMI - Social Support Survey Total Score at 6 months
10813545|NCT01590628|BG000|Baseline|NiCord + Unmanipulated CBU|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The NiCord was transplanted together with an unmanipulated CBU graft."
10813546|NCT01590628|BG001|Baseline|NiCord|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The NiCord was transplanted as a standalone product."
10813547|NCT01590628|BG002|Baseline|Total|Total of all reporting groups
10813548|NCT01590628|FG000|Participant Flow|NiCord + Unmanipulated CBU|NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. NiCord was transplanted in Part 1 subjects, together with an unmanipulated CBU.
10813549|NCT01590628|FG001|Participant Flow|NiCord|NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. NiCord was transplanted in Part 2 subjects as a standalone graft.
10813550|NCT01590628|OG000|Outcome|NiCord + Unmanipulated CBU|Participants who received NiCord together with an unmanipulated CBU.
10813551|NCT01590628|OG001|Outcome|NiCord|Participants who received NiCord as a standalone graft.
10813552|NCT01590628|OG000|Outcome|NiCord + Unmanipulated CBU|NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. NiCord was transplanted in Part 1 subjects, together with an unmanipulated CBU.
10813553|NCT01590628|OG001|Outcome|NiCord as a Standalone Graft|NiCord was transplanted as a stand-alone graft in subjects that participated in Part 2.
10813554|NCT01590628|OG000|Outcome|NiCord + Unmanipulated CBU|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The NiCord was transplanted together with an unmanipulated CBU graft."
10813555|NCT01590628|OG001|Outcome|NiCord|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The NiCord was transplanted as a standalone product."
10813556|NCT01590628|EG000|Reported Event|NiCord + Unmanipulated CBU|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The primary safety objective was to assess the acute toxicity associated with the infusion of omidubicel within 24 hours post-infusion.~Part 1: The primary efficacy objective of Part 1 was to assess the cumulative incidence of donor-derived neutrophil engraftment by Day 42 following co-transplantation of omidubicel and unmanipulated cord blood grafts."
10813557|NCT01590628|EG001|Reported Event|NiCord|"NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.~The primary safety objective was to assess the acute toxicity associated with the infusion of omidubicel within 24 hours post-infusion.~Part 2: The primary efficacy objective of Part 2 was to assess the cumulative incidence of donor-derived neutrophil engraftment by Day 42 following transplantation of single unit omidubicel."
10813558|NCT01533714|BG000|Baseline|RA0083 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
10813559|NCT01533714|BG001|Baseline|RA0083 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813560|NCT01533714|BG002|Baseline|RA0083 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813561|NCT01533714|BG003|Baseline|RA0083 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813562|NCT01533714|BG004|Baseline|RA0083 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813563|NCT01533714|BG005|Baseline|RA0083 Placebo|Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813564|NCT01533714|BG006|Baseline|Total|Total of all reporting groups
10813565|NCT01533714|FG000|Participant Flow|RA0083 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
10813566|NCT01533714|FG001|Participant Flow|RA0083 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813567|NCT01533714|FG002|Participant Flow|RA0083 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813568|NCT01533714|FG003|Participant Flow|RA0083 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813569|NCT01533714|FG004|Participant Flow|RA0083 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813570|NCT01533714|FG005|Participant Flow|RA0083 Placebo|Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813571|NCT01533714|OG000|Outcome|RA0083 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
10813572|NCT01533714|OG001|Outcome|RA0083 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813573|NCT01533714|OG002|Outcome|RA0083 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
11206131|NCT02233738|OG001|Outcome|LSEG - Social Support Survey Total Score at 6 Months|LSEG - Social Support Survey Total Score at 6 months
10813574|NCT01533714|OG003|Outcome|RA0083 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813575|NCT01533714|OG004|Outcome|RA0083 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813576|NCT01533714|OG005|Outcome|RA0083 Placebo|Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
10813577|NCT01533714|EG000|Reported Event|RA0083 CDP6038 (Olokizumab) 120 mg q2w|CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
10813578|NCT01533714|EG001|Reported Event|RA0083 CDP6038 (Olokizumab) 120 mg q4w|CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
11206132|NCT02233738|OG000|Outcome|GMI - Quality of Life Survey (QOLS) at Baseline|GMI - Quality of Life Survey (QOLS) at Baseline
11206133|NCT02233738|OG001|Outcome|LSEG - Quality of Life Survey (QOLS) at Baseline|LSEG - Quality of Life Survey (QOLS) at Baseline
11206134|NCT02233738|OG000|Outcome|GMI - Quality of Life Survey (QOLS) at 1 Month|GMI - Quality of Life Survey (QOLS) at 1 month
10813579|NCT01533714|EG002|Reported Event|RA0083 CDP6038 (Olokizumab) 240 mg q4w|CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813580|NCT01533714|EG003|Reported Event|RA0083 CDP6038 (Olokizumab) 60 mg q2w|CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813581|NCT01533714|EG004|Reported Event|RA0083 CDP6038 (Olokizumab) 60 mg q4w|CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
10813582|NCT01533714|EG005|Reported Event|RA0083 Placebo|Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
10813583|NCT00002931|BG000|Baseline|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
10813584|NCT00002931|FG000|Participant Flow|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
10821868|NCT00072176|BG000|Baseline|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
11206135|NCT02233738|OG001|Outcome|LSEG - Quality of Life Survey (QOLS) at 1 Month|LSEG - Quality of Life Survey (QOLS) at 1 month
11206136|NCT02233738|OG000|Outcome|GMI - Quality of Life Survey (QOLS) at 3 Months|GMI - Quality of Life Survey (QOLS) at 3 months
11206137|NCT02233738|OG001|Outcome|LSEG - Quality of Life Survey (QOLS) at 3 Months|LSEG - Quality of Life Survey (QOLS) at 3 months
11206138|NCT02233738|OG000|Outcome|GMI - Quality of Life Survey (QOLS) at 6 Months|GMI - Quality of Life Survey (QOLS) at 6 months
11206139|NCT02233738|OG001|Outcome|LSEG - Quality of Life Survey (QOLS) at 6 Months|LSEG - Quality of Life Survey (QOLS) at 6 months
11206140|NCT02233738|OG000|Outcome|GMI - Brief Symptom Inventory (BSI) at Baseline|GMI - Brief Symptom Inventory (BSI) at Baseline
11206141|NCT02233738|OG001|Outcome|LSEG - Brief Symptom Inventory (BSI) at Baseline|LSEG - Brief Symptom Inventory (BSI) at Baseline
11206142|NCT02233738|OG000|Outcome|GMI - Brief Symptom Inventory (BSI) at 1 Month|GMI - Brief Symptom Inventory (BSI) at 1 month
11206143|NCT02233738|OG001|Outcome|LSEG - Brief Symptom Inventory (BSI) at 1 Month|LSEG - Brief Symptom Inventory (BSI) at 1 month
11206144|NCT02233738|OG000|Outcome|GMI - Brief Symptom Inventory (BSI) at 3 Months|GMI - Brief Symptom Inventory (BSI) at 3 months
11206145|NCT02233738|OG001|Outcome|LSEG - Brief Symptom Inventory (BSI) at 3 Months|LSEG - Brief Symptom Inventory (BSI) at 3 months
11206146|NCT02233738|OG000|Outcome|GMI - Brief Symptom Inventory (BSI) at 6 Months|GMI - Brief Symptom Inventory (BSI) at 6 months
11206147|NCT02233738|OG001|Outcome|LSEG - Brief Symptom Inventory (BSI) at 6 Months|LSEG - Brief Symptom Inventory (BSI) at 6 months
11206148|NCT02233738|OG000|Outcome|GMI - Health Survey Physical Summary Score at Baseline|GMI - Health Survey Physical Summary Score at Baseline
11206149|NCT02233738|OG001|Outcome|LSEG - Health Survey Physical Summary Score at Baseline|LSEG - Health Survey Physical Summary Score at Baseline
11206150|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Physical Summary Score at 1 Month|GMI - SF-12 Health Survey Physical Summary Score at 1 month
10813585|NCT00002931|OG000|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
10813586|NCT00002931|EG000|Reported Event|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
10813587|NCT00003138|BG000|Baseline|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
10813588|NCT00003138|BG001|Baseline|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
10813589|NCT00003138|BG002|Baseline|Total|Total of all reporting groups
10813590|NCT00003138|FG000|Participant Flow|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
10813591|NCT00003138|FG001|Participant Flow|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
10813592|NCT00003138|OG000|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
10813593|NCT00003138|OG001|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
10813594|NCT00003138|EG000|Reported Event|Supportive Care (Step 1)|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
10813595|NCT00003138|EG001|Reported Event|Erythropoietin (Step 1)|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
10813596|NCT00003138|EG002|Reported Event|Erythropoietin (Cross-over; Step 2)|Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
10813597|NCT00003138|EG003|Reported Event|Erythropoietin (150 Units/kg) and Filgrastim (Step 3)|All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
10813598|NCT00003138|EG004|Reported Event|Erythropoietin (300 Units/kg) and Filgrastim (Step 4)|All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
10813599|NCT00003199|BG000|Baseline|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
10813600|NCT00003199|FG000|Participant Flow|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
10821869|NCT00072176|BG001|Baseline|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10967071|NCT00891176|OG000|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967072|NCT00891176|OG001|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
11206151|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Physical Summary Score at 1 Month|LSEG - SF-12 Health Survey Physical Summary Score at 1 month
10813601|NCT00003199|OG000|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
10813602|NCT00003199|EG000|Reported Event|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
10813603|NCT00003222|BG000|Baseline|Peptides Pulsed on Dendritic Cells|
10813604|NCT00003222|BG001|Baseline|Peptides in GMCSF-in-adjuvant|
10813605|NCT00003222|BG002|Baseline|Total|Total of all reporting groups
10813606|NCT00003222|FG000|Participant Flow|Peptides Pulsed on Dendritic Cells|---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
10813607|NCT00003222|FG001|Participant Flow|Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant|---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
10813608|NCT00003222|OG000|Outcome|Peptides Pulsed on Dendritic Cells|
10813609|NCT00003222|OG001|Outcome|Peptides in GMCSF-in-adjuvant|
10813610|NCT00003222|EG000|Reported Event|Peptides Pulsed on Dendritic Cells|
10813611|NCT00003222|EG001|Reported Event|Peptides in GMCSF-in-adjuvant|
10813612|NCT00003224|BG000|Baseline|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813613|NCT00003224|BG001|Baseline|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813614|NCT00003224|BG002|Baseline|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813615|NCT00003224|BG003|Baseline|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813616|NCT00003224|BG004|Baseline|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813617|NCT00003224|BG005|Baseline|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813618|NCT00003224|BG006|Baseline|Total|Total of all reporting groups
10813619|NCT00003224|FG000|Participant Flow|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813620|NCT00003224|FG001|Participant Flow|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813621|NCT00003224|FG002|Participant Flow|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813622|NCT00003224|FG003|Participant Flow|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813623|NCT00003224|FG004|Participant Flow|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813624|NCT00003224|FG005|Participant Flow|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813625|NCT00003224|OG000|Outcome|All QS-21|The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
10813626|NCT00003224|OG001|Outcome|All Montanide ISA-51|The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
10813627|NCT00003224|OG000|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813628|NCT00003224|OG001|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813629|NCT00003224|OG002|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813630|NCT00003224|OG003|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813631|NCT00003224|OG004|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
10813632|NCT00003224|OG005|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
10813633|NCT00003224|EG000|Reported Event|QS-21 Adjuvant|The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
10813634|NCT00003224|EG001|Reported Event|Montanide ISA-51 Adjuvant|The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
10813635|NCT00003270|BG000|Baseline|Arm 1|Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
10813636|NCT00003270|FG000|Participant Flow|Arm 1|Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
10813637|NCT00003270|OG000|Outcome|Arm 1|Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
10821870|NCT00072176|BG002|Baseline|Total|Total of all reporting groups
10813638|NCT00003270|EG000|Reported Event|Arm 1|Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
10821871|NCT00072176|FG000|Participant Flow|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821872|NCT00072176|FG001|Participant Flow|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821873|NCT00072176|OG000|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821874|NCT00072176|OG001|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821875|NCT00072176|EG000|Reported Event|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821876|NCT00072176|EG001|Reported Event|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10821877|NCT00072189|BG000|Baseline|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10821878|NCT00072189|FG000|Participant Flow|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10821879|NCT00072189|OG000|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10821880|NCT00072189|EG000|Reported Event|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10821881|NCT00072280|BG000|Baseline|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
10821882|NCT00072280|BG001|Baseline|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
10821883|NCT00072280|BG002|Baseline|Total|Total of all reporting groups
10821884|NCT00072280|FG000|Participant Flow|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
10821885|NCT00072280|FG001|Participant Flow|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
10821886|NCT00072280|OG000|Outcome|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
10821887|NCT00072280|EG000|Reported Event|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
10821888|NCT00072280|EG001|Reported Event|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
11206152|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Physical Summary Score at 3 Months|GMI - SF-12 Health Survey Physical Summary Score at 3 months
10813639|NCT04848662|BG000|Baseline|A/B - Treatment With BDA MDI (PT027) 160/180 μg Followed by Treatment With Pulmicort Respules 1mg|"Subjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2/Period 1, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3/Period 2.~Visit 2/Period 1 (Day 1) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.~Visit 3/Period 2 (Day 8 +/- 6 days) - Pulmicort Respules 0.5 mg/mL inhalation suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide."
10813640|NCT04848662|BG001|Baseline|B/A - Treatment With Pulmicort Respules 1 mg Followed by Treatment With BDA MDI (PT027) 160/180 μg|"Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3.~Visit 2/Period 1 (Day 1) - Pulmicort Respules 0.5 MG/ML Inhalation Suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.~Visit 3/Period 2 (Day 8 +/- 6 days) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose."
10813641|NCT04848662|BG002|Baseline|Total|Total of all reporting groups
10813642|NCT04848662|FG000|Participant Flow|A/B - Treatment With BDA MDI (PT027) 160/180 μg Followed by Treatment With Pulmicort Respules 1mg|"Subjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2/Period 1, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3/Period 2.~Visit 2/Period 1 (Day 1) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.~Visit 3/Period 2 (Day 8 +/- 6 days) - Pulmicort Respules 0.5 mg/mL inhalation suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide."
10813643|NCT04848662|FG001|Participant Flow|B/A - Treatment With Pulmicort Respules 1 mg Followed by Treatment With BDA MDI (PT027) 160/180 μg|"Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3.~Visit 2/Period 1 (Day 1) - Pulmicort Respules 0.5 MG/ML Inhalation Suspension: Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.~Visit 3/Period 2 (Day 8 +/- 6 days) - BDA MDI (PT027) 160/180 μg: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose."
10813644|NCT04848662|OG000|Outcome|Treatment Intervention - BDA MDI (PT027) 160/180 μg - All Subjects|Individual PK parameters and summary statistics after administration of study treatment A - BDA MDI (PT027) 160/180 μg
10813645|NCT04848662|OG001|Outcome|Treatment Intervention B - Pulmicort Respules 1 mg|Individual PK parameters and summary statistics after administration of study treatment B - Pulmicort Respules 1mg
10813646|NCT04848662|EG000|Reported Event|Treatment Intervention - BDA MDI (PT027) 160/180 μg - All Subjects|Safety analysis of subjects receiving Treatment A - BDA MDI (PT027) 160/180 μg
10813647|NCT04848662|EG001|Reported Event|Treatment Intervention B - Pulmicort Respules 1 mg|Safety analysis of subjects receiving Treatment B - Pulmicort Respules 1mg
10813648|NCT04697693|BG000|Baseline|Treatment With Escitalopram or Duloxetine|"Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.~Escitalopram: he participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.~Duloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study."
10813649|NCT04697693|FG000|Participant Flow|Treatment With Escitalopram or Duloxetine|"Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.~Escitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.~Duloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study."
10821889|NCT00072293|BG000|Baseline|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
10821890|NCT00072293|BG001|Baseline|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
10821891|NCT00072293|BG002|Baseline|Total|Total of all reporting groups
11206153|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Physical Summary Score at 3 Months|LSEG - SF-12 Health Survey Physical Summary Score at 3 months
11206154|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Physical Summary Score at 6 Months|GMI - SF-12 Health Survey Physical Summary Score at 6 months
11206155|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Physical Summary Score at 6 Months|LSEG - SF-12 Health Survey Physical Summary Score at 6 months
11206156|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Mental Summary Score at Baseline|GMI - SF-12 Health Survey Mental Summary Score at Baseline
11206157|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Mental Summary Score at Baseline|LSEG - SF-12 Health Survey Mental Summary Score at Baseline
11206158|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Mental Summary Score at 1 Month|GMI - SF-12 Health Survey Mental Summary Score at 1 month
11206159|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Mental Summary Score at 1 Month|LSEG - SF-12 Health Survey Mental Summary Score at 1 month
11206160|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Mental Summary Score at 3 Months|GMI - SF-12 Health Survey Mental Summary Score at 3 months
10813650|NCT04697693|OG000|Outcome|Treatment With Escitalopram or Duloxetine|"Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.~Escitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.~Duloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study."
10813651|NCT04697693|EG000|Reported Event|Treatment With Escitalopram or Duloxetine|"Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.~Escitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.~Duloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study."
10821892|NCT00072293|FG000|Participant Flow|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
10821893|NCT00072293|FG001|Participant Flow|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
10821894|NCT00072293|OG000|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
10821895|NCT00072293|OG001|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
10821896|NCT00072293|EG000|Reported Event|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
10821897|NCT00072293|EG001|Reported Event|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
10821898|NCT00072384|BG000|Baseline|Treatment (Chemotherapy, Surgery)|"Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.~liposomal vincristine sulfate: Given IV~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue~carboplatin: Given IV~etoposide: Given IV~filgrastim: Given subcutaneously"
10821899|NCT00072384|FG000|Participant Flow|Treatment (Chemotherapy, Surgery)|"Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.~liposomal vincristine sulfate: Given IV~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue~carboplatin: Given IV~etoposide: Given IV~filgrastim: Given subcutaneously"
10821900|NCT00072384|OG000|Outcome|Treatment (Chemotherapy, Surgery)|"Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.~liposomal vincristine sulfate: Given IV~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue~carboplatin: Given IV~etoposide: Given IV~filgrastim: Given subcutaneously"
11206161|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Mental Summary Score at 3 Months|LSEG - SF-12 Health Survey Mental Summary Score at 3 months
11206162|NCT02233738|OG000|Outcome|GMI - SF-12 Health Survey Mental Summary Score at 6 Months|GMI - SF-12 Health Survey Mental Summary Score at 6 months
11206163|NCT02233738|OG001|Outcome|LSEG - SF-12 Health Survey Mental Summary Score at 6 Months|LSEG - SF-12 Health Survey Mental Summary Score at 6 months
11206164|NCT02233738|OG000|Outcome|GMI - Treatment Motivation Questionnaire (TMQ) at Baseline|For those receiving GMI - The TMQ was used to assess self-reported interest in treatment at Baseline based on external reasons, internal reasons, help seeking and confidence.
11206165|NCT02233738|OG001|Outcome|LSEG - Treatment Motivation Questionnaire (TMQ) at Baseline|For those receiving GMI - The TMQ was used to assess self-reported interest in treatment at Baseline based on external reasons, internal reasons, help seeking and confidence.
11206166|NCT02233738|OG000|Outcome|GMI - Treatment Motivation Questionnaire (TMQ) at 1-month|Treatment Motivation Questionnaire (TMQ) at 1-month
11206167|NCT02233738|OG001|Outcome|LSEG - Treatment Motivation Questionnaire (TMQ) at 1-month|LSEG - Treatment Motivation Questionnaire (TMQ) at 1-month
11206168|NCT02233738|OG000|Outcome|GMI - Treatment Motivation Questionnaire (TMQ) at 3-month|GMI - Treatment Motivation Questionnaire (TMQ) at 3-month
11206169|NCT02233738|OG001|Outcome|LSEG - Treatment Motivation Questionnaire (TMQ) at 3-month|LSEG - Treatment Motivation Questionnaire (TMQ) at 3-month
11206170|NCT02233738|OG000|Outcome|GMI - Treatment Motivation Questionnaire (TMQ) at 6-month|GMI - Treatment Motivation Questionnaire (TMQ) at 6-month
11206171|NCT02233738|OG001|Outcome|LSEG - Treatment Motivation Questionnaire (TMQ) at 6-month|LSEG - Treatment Motivation Questionnaire (TMQ) at 6-month
10813652|NCT03969719|BG000|Baseline|Placebo|All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
10813653|NCT03969719|BG001|Baseline|PF-06835919 150 mg|All participants received PF-06835919 150 mg QD for 16 Weeks.
10813654|NCT03969719|BG002|Baseline|PF-06835919 300 mg|All participants received PF-06835919 300 mg QD for 16 Weeks.
10813655|NCT03969719|BG003|Baseline|Total|Total of all reporting groups
10813656|NCT03969719|FG000|Participant Flow|Placebo|All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
10813657|NCT03969719|FG001|Participant Flow|PF-06835919 150 mg|All participants received PF-06835919 150 mg QD for 16 Weeks.
10813658|NCT03969719|FG002|Participant Flow|PF-06835919 300 mg|All participants received PF-06835919 300 mg QD for 16 Weeks.
10813659|NCT03969719|OG000|Outcome|Placebo|All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
10813660|NCT03969719|OG001|Outcome|PF-06835919 150 mg|All participants received PF-06835919 150 mg QD for 16 Weeks.
10813661|NCT03969719|OG002|Outcome|PF-06835919 300 mg|All participants received PF-06835919 300 mg QD for 16 Weeks.
10813662|NCT03969719|EG000|Reported Event|Placebo|All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
10813663|NCT03969719|EG001|Reported Event|PF-06835919 150 mg|All participants received PF-06835919 150 mg QD for 16 Weeks.
10813664|NCT03969719|EG002|Reported Event|PF-06835919 300 mg|All participants received PF-06835919 300 mg QD for 16 Weeks.
10813665|NCT03883477|BG000|Baseline|Endoscopic Release|"13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.~Endoscopic Release: Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices."
10813666|NCT03883477|BG001|Baseline|Standard Open Release|"13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.~Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger."
10813667|NCT03883477|BG002|Baseline|Total|Total of all reporting groups
10813668|NCT03883477|FG000|Participant Flow|Endoscopic Release|"13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.~Endoscopic Release: Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices."
10813669|NCT03883477|FG001|Participant Flow|Standard Open Release|"13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.~Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger."
10813670|NCT03883477|OG000|Outcome|Endoscopic Release|"13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.~Endoscopic Release: Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices."
10813671|NCT03883477|OG001|Outcome|Standard Open Release|"13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.~Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger."
10813672|NCT03883477|EG000|Reported Event|Endoscopic Release|"13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.~Endoscopic Release: Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices."
10813673|NCT03883477|EG001|Reported Event|Standard Open Release|"13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.~Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger."
10813674|NCT03813108|BG000|Baseline|1: NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813675|NCT03813108|BG001|Baseline|2: Low Dose NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 5 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10821901|NCT00072384|OG000|Outcome|Group C Eyes|"Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding~Subretinal fluid, without prior or concurrent seeding, involving ≤ one quarter of the retina~Local fine vitreous seeding may be present close to discrete tumor~Local subretinal seeding < 3 mm from tumor"
11206172|NCT02233738|OG000|Outcome|GMI - Fagerstrom Test for Nicotine Dependence at Baseline|GMI - Fagerstrom Test for Nicotine Dependence at Baseline
10813676|NCT03813108|BG002|Baseline|3: NF135 CPS-immunization (A/L) Challenged by NF135 Cohorst B|"20 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes and are presumptively treated with artemether/lumefantrine starting on day 7 after each immunization. 10 volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes. 10 volunteers will be challenged by the bites of 5 NF54 infected Anopheles mosquitoes.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~CPS-immunization (A/L): Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine initiated on day 7 after each immunization.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813677|NCT03813108|BG003|Baseline|5: Control Group Challenged by NF135.C10 Cohort A|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813678|NCT03813108|BG004|Baseline|6: Control Group Challenged by NF54 Cohort B|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF54 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF54: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813679|NCT03813108|BG005|Baseline|7: Control Group Challenged by NF135 Cohort B|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813680|NCT03813108|BG006|Baseline|Total|Total of all reporting groups
10813681|NCT03813108|FG000|Participant Flow|1: NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813682|NCT03813108|FG001|Participant Flow|2: Low Dose NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 5 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813683|NCT03813108|FG002|Participant Flow|3: NF135 CPS-immunization (A/L) Cohort B|"20 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes and are presumptively treated with artemether/lumefantrine starting on day 7 after each immunization. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes.~malaria challenge infection, P. falciparum NF135.C10: 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites. 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.~CPS-immunization (A/L): Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine initiated on day 7 after each immunization.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10821902|NCT00072384|OG001|Outcome|Group D Eyes|"Group D: Diffuse disease with significant vitreous and/or subretinal seeding~Tumor(s) may be massive or diffuse~Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment~Diffuse or massive vitreous disease may include greasy seeds or avascular tumor masses~Diffuse subretinal seeding may include subretinal plaques or tumor nodules"
11244339|NCT02510001|OG006|Outcome|Dose Escalation Phase Dose 5 (Interval Dosing)|"Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11244340|NCT02510001|OG007|Outcome|Dose Expansion Phase|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11206173|NCT02233738|OG001|Outcome|LSEG - Fagerstrom Test for Nicotine Dependence at Baseline|LSEG - Fagerstrom Test for Nicotine Dependence at Baseline
11206174|NCT02233738|OG000|Outcome|GMI - GMI - Psychiatric Outpatient Satisfaction Scale - Total|GMI - Psychiatric Outpatient Satisfaction Scale - Total Score
11206175|NCT02233738|OG001|Outcome|LSEG - GMI - Psychiatric Outpatient Satisfaction Scale - Total|LSEG - GMI - Psychiatric Outpatient Satisfaction Scale - Total Score
11206176|NCT02233738|OG000|Outcome|GMI - Helping Alliance Questionnaire - Total Score|GMI - Helping Alliance Questionnaire - Total Score
11206177|NCT02233738|OG001|Outcome|LSEG - Helping Alliance Questionnaire - Total Score|LSEG - Psychiatric Outpatient Satisfaction Scale - Total Score
11206178|NCT02233738|EG000|Reported Event|Group Motivational Interviewing (GMI)|Group Motivational Interviewing (GMI) participants will receive four structured, back-to-back, 90-min sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
10813684|NCT03813108|FG003|Participant Flow|5: Control Group Challenged by NF135.C10 Cohort A|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813685|NCT03813108|FG004|Participant Flow|6: Control Group Challenged by NF54 Cohort B|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF54 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF54: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813686|NCT03813108|FG005|Participant Flow|7: Control Group Challenged by NF135 Cohort B|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813687|NCT03813108|OG000|Outcome|1: NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10847657|NCT00284557|OG001|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
11206179|NCT02233738|EG001|Reported Event|Control Treatment Condition (CT)|Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity', participants will anonymously submit questions on involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion money management with feedback (2 sessions), cooking-home maintenance, and psycho-education about substance use.
11206180|NCT02233751|BG000|Baseline|Testosterone Enanthate 50 mg|Testosterone enanthate auto-injector 50 mg
11206181|NCT02233751|BG001|Baseline|Testosterone Enanthate 200 mg|Testosterone enanthate auto-injector 200 mg
11206182|NCT02233751|BG002|Baseline|Total|Total of all reporting groups
11206183|NCT02233751|FG000|Participant Flow|Testosterone Enanthate 50 mg|"Testosterone enanthate auto-injector~50 mg SC injection"
11206184|NCT02233751|FG001|Participant Flow|Testosterone Enanthate 200 mg|"Testosterone enanthate auto-injector~200 mg SC injection"
11206185|NCT02233751|OG000|Outcome|Testosterone Enanthate 50 mg|Testosterone enanthate auto-injector 50 mg
11206186|NCT02233751|OG001|Outcome|Testosterone Enanthate 200 mg|Testosterone enanthate auto-injector 200 mg
11206187|NCT02233751|EG000|Reported Event|Treatment A|Testosterone enanthate auto-injector (SC injection) Treatment A
11206188|NCT02233751|EG001|Reported Event|Treatment B|Testosterone enanthate auto-injector (SC injections) Treatment B
11206189|NCT02233803|BG000|Baseline|Total|The eligible participants were randomised to receive either Regimen A in TP1 and Regimen B in TP2, or Regimen B in TP1 and Regimen A in TP2 according to the randomisation schedule. Both the TPs were separated by a wash out period of 4 weeks. Regimen A: 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening. Regimen B: 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE) by turbuhaler inhaler each morning and evening. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
10813688|NCT03813108|OG001|Outcome|2: Low Dose NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 5 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813689|NCT03813108|OG002|Outcome|3: NF135 CPS-immunization (A/L) Cohort B|"20 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes and are presumptively treated with artemether/lumefantrine starting on day 7 after each immunization. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes.~malaria challenge infection, P. falciparum NF135.C10: 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites. 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.~CPS-immunization (A/L): Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine initiated on day 7 after each immunization.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813690|NCT03813108|OG002|Outcome|5: Control Group Challenged by NF135.C10 Cohort A|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813691|NCT03813108|EG000|Reported Event|1: NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813692|NCT03813108|EG001|Reported Event|2: Low Dose NF135 CPS-immunization Challenged by NF135|"10 volunteers will receive three immunizations with 5 NF135.C10 infected Anopheles mosquitoes under mefloquine prophylaxis. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~CPS-immunization: Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813693|NCT03813108|EG002|Reported Event|3: NF135 CPS-immunization (A/L) Cohort B|"20 volunteers will receive three immunizations with 15 NF135.C10 infected Anopheles mosquitoes and are presumptively treated with artemether/lumefantrine starting on day 7 after each immunization. Volunteers will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes.~malaria challenge infection, P. falciparum NF135.C10: 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites. 10 Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.~CPS-immunization (A/L): Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine initiated on day 7 after each immunization.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813694|NCT03813108|EG003|Reported Event|5: Control Group Challenged by NF135.C10 Cohort A|"Challenge infection control group: 3 volunteers will receive no immunization and will be challenged by the bites of 5 NF135.C10 infected Anopheles mosquitoes 19 weeks after the last immunization.~malaria challenge infection, P. falciparum NF135.C10: Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.~Atovaquone / Proguanil Oral Tablet [Malarone]: All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection."
10813695|NCT03809611|BG000|Baseline|UNR844-Cl|1.5% UNR844-Cl
10813696|NCT03809611|BG001|Baseline|Placebo Ophthalmic Solution|placebo
10813697|NCT03809611|BG002|Baseline|Total|Total of all reporting groups
10813698|NCT03809611|FG000|Participant Flow|UNR844-Cl|1.5% UNR844-Cl
10813699|NCT03809611|FG001|Participant Flow|Placebo Ophthalmic Solution|placebo
10813700|NCT03809611|OG000|Outcome|UNR844-Cl|1.5% UNR844-Cl
10813701|NCT03809611|OG001|Outcome|Placebo Ophthalmic Solution|placebo
10813702|NCT03809611|EG000|Reported Event|UNR844-Cl|UNR844-Cl
10813703|NCT03809611|EG001|Reported Event|Placebo|Placebo
10813704|NCT03809611|EG002|Reported Event|Total|Total
10847658|NCT00284557|EG000|Reported Event|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
11206190|NCT02233803|FG000|Participant Flow|NEUMOTEROL 400/ SYMBICORT FORTE|During TP1, participants received Regimen A where the eligible participants received, 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening for 4- weeks (Wks). This was followed by a wash out period of 4 Wks , during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. The wash-out period was followed by Regimen B during which the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
11206191|NCT02233803|FG001|Participant Flow|SYMBICORT FORTE/ NEUMOTEROL 400|During TP1, the participants received Regimen B where the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening for 4-Wks. This was followed by a wash out period of 4 Wks, during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. It was then followed by Regimen A during which eligible participants received, 1 inhalation of NEUMOTEROL 400 by single capsule inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
11206192|NCT02233803|OG000|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pressurized metered dose inhaler (pMDI), as rescue medication.
11206193|NCT02233803|OG001|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization . The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
11206194|NCT02233803|OG000|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
11206195|NCT02233803|OG001|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
10813705|NCT03721705|BG000|Baseline|Treatment Arm|"The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813706|NCT03721705|BG001|Baseline|Sham Arm|"The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813707|NCT03721705|BG002|Baseline|Total|Total of all reporting groups
10813708|NCT03721705|FG000|Participant Flow|Treatment Arm|"The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813709|NCT03721705|FG001|Participant Flow|Sham Arm|"The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813710|NCT03721705|OG000|Outcome|Treatment Arm|"The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813711|NCT03721705|OG001|Outcome|Sham Arm|"The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813712|NCT03721705|EG000|Reported Event|Treatment Arm|"The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813713|NCT03721705|EG001|Reported Event|Sham Arm|"The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments.~Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks."
10813714|NCT03505021|BG000|Baseline|Levosimendan|"Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks~Levosimendan: Levosimendan 1 mg capsule for oral administration"
10813715|NCT03505021|BG001|Baseline|Placebo for Levosimendan|"Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.~Placebo for levosimendan: Placebo capsule for oral administration"
10813716|NCT03505021|BG002|Baseline|Total|Total of all reporting groups
10813717|NCT03505021|FG000|Participant Flow|Levosimendan|"Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks~Levosimendan: Levosimendan 1 mg capsule for oral administration"
10813718|NCT03505021|FG001|Participant Flow|Placebo for Levosimendan|"Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.~Placebo for levosimendan: Placebo capsule for oral administration"
10813719|NCT03505021|OG000|Outcome|Levosimendan|"Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks~Levosimendan: Levosimendan 1 mg capsule for oral administration"
10813720|NCT03505021|OG001|Outcome|Placebo for Levosimendan|"Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.~Placebo for levosimendan: Placebo capsule for oral administration"
10813721|NCT03505021|EG000|Reported Event|Levosimendan|"Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks~Levosimendan: Levosimendan 1 mg capsule for oral administration"
11206196|NCT02233803|EG000|Reported Event|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
11206197|NCT02233803|EG001|Reported Event|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
11206198|NCT02233842|BG000|Baseline|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products"
10813722|NCT03505021|EG001|Reported Event|Placebo for Levosimendan|"Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.~Placebo for levosimendan: Placebo capsule for oral administration"
10813723|NCT03405714|BG000|Baseline|Age Cohort: >=12 to <16 Years|Screening Period (1-10 days): Participants receiving open-label BRV (OLB) or prescribed oral BRV (RxB) continued to receive oral BRV. IOB Treatment Period (2-10 days): Participants who initiated Oral BRV (IOB) continued with oral BRV 2 milligram/kilogram/day (mg/kg/day). IV PK (Intravenous Pharmacokinetic) Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv Brivaracetam (BRV) dose was equivalent to final dose of oral BRV and for Initiating iv BRV (IIB) participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813724|NCT03405714|BG001|Baseline|Age Cohort: >=6 to <12 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813725|NCT03405714|BG002|Baseline|Age Cohort: >=2 to <6 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813726|NCT03405714|BG003|Baseline|Age Cohort: >=1 Month to <2 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813727|NCT03405714|BG004|Baseline|Total Title|
10813728|NCT03405714|FG000|Participant Flow|Age Cohort: >=12 to <16 Years|Screening Period (1-10 days): Participants receiving open-label BRV (OLB) or prescribed oral BRV (RxB) continued to receive oral BRV. IOB Treatment Period (2-10 days): Participants who initiated Oral BRV (IOB) continued with oral BRV 2 milligram/kilogram/day (mg/kg/day). IV PK (Intravenous Pharmacokinetic) Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv Brivaracetam (BRV) dose was equivalent to final dose of oral BRV and for Initiating iv BRV (IIB) participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813729|NCT03405714|FG001|Participant Flow|Age Cohort: >=6 to <12 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813730|NCT03405714|FG002|Participant Flow|Age Cohort: >=2 to <6 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813731|NCT03405714|FG003|Participant Flow|Age Cohort: >=1 Month to <2 Years|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
10813732|NCT03405714|OG000|Outcome|Age Cohort: >=12 to <16 Years (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).
10813733|NCT03405714|OG001|Outcome|Age Cohort: >=6 to <12 Years (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
10813734|NCT03405714|OG002|Outcome|Age Cohort: >=2 to <6 Years (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
10813735|NCT03405714|OG003|Outcome|Age Cohort : >=1 Month to <2 Years (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
10813736|NCT03405714|OG000|Outcome|15-minute Infusion (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS.
10813737|NCT03405714|OG000|Outcome|Bolus (PK-PPS)|Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
10813738|NCT03405714|OG000|Outcome|Age Cohort: >=12 to <16 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv).
10813739|NCT03405714|OG001|Outcome|Age Cohort: >=6 to <12 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
10813740|NCT03405714|OG002|Outcome|Age Cohort: >=2 to <6 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety SS-iv.
10813741|NCT03405714|OG003|Outcome|Age Cohort: >=1 Month to <2 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
10813742|NCT03405714|EG000|Reported Event|Age Cohort: >=12 to <16 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv).
10813743|NCT03405714|EG001|Reported Event|Age Cohort: >=6 to <12 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
10813744|NCT03405714|EG002|Reported Event|Age Cohort: >=2 to <6 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety SS-iv.
10813745|NCT03405714|EG003|Reported Event|Age Cohort: >=1 Month to <2 Years (SS-iv)|Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
10813746|NCT03366194|BG000|Baseline|Experimental|"Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.~SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars."
10813747|NCT03366194|FG000|Participant Flow|SkinStylus Sterilock System Intervention|"Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.~SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars."
10813748|NCT03366194|OG000|Outcome|Experimental|"Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.~SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars."
10813749|NCT03366194|OG000|Outcome|Experimental|"Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.~SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.~Prior to any treatment, each subject shall self-evaluate the appearance of their scar using the validated Self Assessed Scar Improvement Scale.~90 days after the last treatment, each subject shall self-evaluate the appearance of the treated area of their scar using the validated Self Assessed Scar Improvement Scale."
10813750|NCT03366194|EG000|Reported Event|SkinStylus Sterilock System Intervention|"Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.~SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars."
10813751|NCT03272139|BG000|Baseline|Interscalene Block (ISB)|"The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813752|NCT03272139|BG001|Baseline|Superior Trunk Block (STB)|"The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813753|NCT03272139|BG002|Baseline|Total|Total of all reporting groups
10813754|NCT03272139|FG000|Participant Flow|Interscalene Block (ISB)|"The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813755|NCT03272139|FG001|Participant Flow|Superior Trunk Block (STB)|"The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813756|NCT03272139|OG000|Outcome|Interscalene Block (ISB)|"The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813757|NCT03272139|OG001|Outcome|Superior Trunk Block (STB)|"The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813758|NCT03272139|EG000|Reported Event|Interscalene Block (ISB)|"The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813759|NCT03272139|EG001|Reported Event|Superior Trunk Block (STB)|"The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.~Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy~Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks"
10813760|NCT03203473|BG000|Baseline|Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)|"Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks)~Serial imaging assessments every 8 weeks~After confirmatory scans, patients are assigned to Arm A or Arm B.~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813761|NCT03203473|FG000|Participant Flow|Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)|"Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles~Serial imaging assessments every 8 weeks~After confirmatory scans, patients are assigned to Arm A or Arm B.~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813762|NCT03203473|FG001|Participant Flow|Arm A: Observation Arm (for Patients With Persistent Response to Induction Nivolumab)|"Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)~Serial imaging assessments every 8 weeks~If progressive disease develops, salvage therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.~If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.~If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression."
10813763|NCT03203473|FG002|Participant Flow|Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)|"Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).~In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.~After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.~Arm B patients underwent imaging at 12 weeks and then every 8 weeks."
10813764|NCT03203473|OG000|Outcome|Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)|"Patients with persistent response (complete or partial response) to induction nivolumab were assigned to Arm A (Observation Arm)~Serial imaging assessments every 8 weeks~If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed.~If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added.~If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression."
10813765|NCT03203473|OG000|Outcome|Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)|"Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).~In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.~After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.~Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks.."
10813766|NCT03203473|OG000|Outcome|Initial Primary Treatment With Nivolumab (Induction Phase)|"Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks)~Serial imaging assessments every 8 weeks~After confirmatory scans, patients are assigned to Arm A or Arm B.~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813767|NCT03203473|OG001|Outcome|Arm B- Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Nivolumab Induction)|"Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).~In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.~After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.~Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks.."
11244341|NCT02510001|OG000|Outcome|Dose Escalation Phase|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10813768|NCT03203473|OG000|Outcome|Initial Primary Treatment With Nivolumab (Induction Phase)|"Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.~Serial imaging assessments every 8 weeks~After confirmatory scans, patients are assigned to Arm A or Arm B.~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813769|NCT03203473|OG000|Outcome|Arm B Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)|"Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).~In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.~After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.~Arm B patients underwent imaging at 12 weeks and then every 8 weeks until disease progression."
10813770|NCT03203473|EG000|Reported Event|Overall Cohort: Initial Primary Treatment With Nivolumab (Induction Phase)|"Therapy with nivolumab (480mg IV) every cycle (1cycle=4 weeks) up to 6 cycles.~Serial imaging assessments every 8 weeks~After confirmatory scans, patients are assigned to Arm A or Arm B.~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813771|NCT03203473|EG001|Reported Event|Arm B: Nivolumab+Ipilimumab Then Nivolumab Alone (for Patients With SD/PD to Induction Nivolumab)|"Patients with confirmed SD/PD to induction nivolumab were allocated to Arm B (Combination Therapy Arm).~In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses.~After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression.~Arm B patients underwent imaging after the first 12 weeks and then every 8 weeks..~Ipilimumab: YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells~Nivolumab: Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs"
10813772|NCT03203473|EG002|Reported Event|Arm A: Arm A-Observation Arm (for Patients With Persistent Response to Induction Nivolumab)|"Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm).~- AE was not reported since this was an observation arm. If a patient resumes nivolumab therapy after progression to arm A, AE from the subsequent therapy was not counted as arm A toxicities."
10813773|NCT03180736|BG000|Baseline|Daratumumab+Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."
10813774|NCT03180736|BG001|Baseline|Pomalidomide + Dexamethasone|Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
10813775|NCT03180736|BG002|Baseline|Total|Total of all reporting groups
10813776|NCT03180736|FG000|Participant Flow|Daratumumab+Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."
10813777|NCT03180736|FG001|Participant Flow|Pomalidomide + Dexamethasone|Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
10813778|NCT03180736|OG000|Outcome|Daratumumab+Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."
10813779|NCT03180736|OG001|Outcome|Pomalidomide + Dexamethasone|Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
10813780|NCT03180736|OG000|Outcome|Daratumumab+Pomalidomide+Dexamethasone|"Daratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle~Daratumumab: Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."
10813781|NCT03180736|OG001|Outcome|Pomalidomide + Dexamethasone|"Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."
10813782|NCT03180736|EG000|Reported Event|Pomalidomide + Dexamethasone|Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
10821903|NCT00072384|EG000|Reported Event|Treatment (Chemotherapy, Surgery)|"Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.~liposomal vincristine sulfate: Given IV~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue~carboplatin: Given IV~etoposide: Given IV~filgrastim: Given subcutaneously"
11206199|NCT02233842|FG000|Participant Flow|Tobacco Use in Cancer Patients and Survivors|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
11206200|NCT02233842|OG000|Outcome|All Participants|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
11206201|NCT02233842|OG000|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
11206202|NCT02233842|EG000|Reported Event|Tobacco Use in Cancer Patients and Survivors|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
11206203|NCT02233946|BG000|Baseline|Computerized Screening w/ Provider Brief Intervention (cSBI)|cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.
11206204|NCT02233946|BG001|Baseline|Computerized Screening With Treatment as Usual (TAU)|The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.
11206205|NCT02233946|BG002|Baseline|Total|Total of all reporting groups
11206206|NCT02233946|FG000|Participant Flow|Computerized Screening w/ Provider Brief Intervention (cSBI)|cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.
11206207|NCT02233946|FG001|Participant Flow|Computerized Screening With Treatment as Usual (TAU)|The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.
11206208|NCT02233946|OG000|Outcome|Computerized Screening w/ Provider Brief Intervention (cSBI)|cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.
11206209|NCT02233946|OG001|Outcome|Computerized Screening With Treatment as Usual (TAU)|The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.
11206210|NCT02233946|EG000|Reported Event|Computerized Screening w/ Provider Brief Intervention (cSBI)|cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.
11206211|NCT02233946|EG001|Reported Event|Computerized Screening With Treatment as Usual (TAU)|The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.
10813783|NCT03180736|EG001|Reported Event|Daratumumab+Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.~7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)]."
10813784|NCT03180736|EG002|Reported Event|Daratumumab (IV) +Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.~7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)]."
10813785|NCT03180736|EG003|Reported Event|Daratumumab (IV/SC) +Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)]."
10813786|NCT03180736|EG004|Reported Event|Daratumumab (SC)+Pomalidomide+Dexamethasone|"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..~Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.~7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)]."
10813787|NCT03051659|BG000|Baseline|Eribulin Mesylate|-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
10813788|NCT03051659|BG001|Baseline|Eribulin Mesylate Combine With Pembrolizumab|"Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.~Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously."
10813789|NCT03051659|BG002|Baseline|Total|Total of all reporting groups
10813790|NCT03051659|FG000|Participant Flow|Eribulin Mesylate|-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
10813791|NCT03051659|FG001|Participant Flow|Eribulin Mesylate Combine With Pembrolizumab|"Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.~Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously."
10813792|NCT03051659|OG000|Outcome|Eribulin Mesylate|-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
10813793|NCT03051659|OG001|Outcome|Eribulin Mesylate Combine With Pembrolizumab|"Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.~Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously."
10813794|NCT03051659|EG000|Reported Event|Eribulin Mesylate Combine With Pembrolizumab|"Pembrolizumab will be administered in clinic once per cycle, given 200mg/m^2 intravenously prior to Eribulin Mesylate.~Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m^2 intravenously."
10813795|NCT03051659|EG001|Reported Event|Eribulin Mesylate|-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
10813796|NCT03048552|BG000|Baseline|Standard of Care - Youth|This arm is comprised of youth from caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
10821904|NCT00072449|BG000|Baseline|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
10821905|NCT00072449|FG000|Participant Flow|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
10813797|NCT03048552|BG001|Baseline|Family CONNECT - Youth|"This arm is comprised of youth from caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813798|NCT03048552|BG002|Baseline|Family Connect - Caregiver|"This arm is comprised of caregivers from caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813799|NCT03048552|BG003|Baseline|Standard of Care - Caregiver|This arm is comprised of caregivers from caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services
10813800|NCT03048552|BG004|Baseline|Total|Total of all reporting groups
10813801|NCT03048552|FG000|Participant Flow|Standard of Care - Youth|This arm is comprised of youth from caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
10813802|NCT03048552|FG001|Participant Flow|Family CONNECT - Youth|"This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813803|NCT03048552|FG002|Participant Flow|Standard of Care - Caregiver|This arm is comprised of caregivers from caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
10813804|NCT03048552|FG003|Participant Flow|Family CONNECT - Caregiver|"This arm is comprised of caregivers from caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813805|NCT03048552|OG000|Outcome|Standard of Care- YOUTH|This arm is comprised of caregiver-youth dyads working with the youth's probation officer (PO) who was randomly assigned to the SOC arm, to work with the PO as usual to link youth to substance use services.
10813806|NCT03048552|OG001|Outcome|Family CONNECT- YOUTH|"This arm is comprised of caregiver-youth dyads working with a probation officer (PO) randomized to the experimental arm. These dyads then worked with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813807|NCT03048552|OG000|Outcome|Standard of Care- YOUTH|This arm is comprised of caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
10813808|NCT03048552|OG001|Outcome|Family CONNECT- YOUTH|"This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813809|NCT03048552|EG000|Reported Event|Standard of Care- Youth|This arm is comprised of youths randomized to work with the youth's probation officer as usual to link youth to substance use services.
10813810|NCT03048552|EG001|Reported Event|Family CONNECT- Youth|"This arm is comprised of youths randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813811|NCT03048552|EG002|Reported Event|Standard of Care- Caregivers|This arm is comprised of caregivers from caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
10813812|NCT03048552|EG003|Reported Event|Family CONNECT- Caregivers|"This arm is comprised of caregivers from caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.~Family CONNECT: Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services."
10813813|NCT02949219|BG000|Baseline|Treatment (Pembrolizumab)|Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10813814|NCT02949219|FG000|Participant Flow|Treatment (Pembrolizumab)|Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10813815|NCT02949219|OG000|Outcome|Treatment (Pembrolizumab)|Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10813816|NCT02949219|EG000|Reported Event|Treatment (Pembrolizumab)|Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10813817|NCT02886884|BG000|Baseline|Pilot Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813818|NCT02886884|BG001|Baseline|Pilot Phase 100 Million hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813819|NCT02886884|BG002|Baseline|Randomized Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813820|NCT02886884|BG003|Baseline|Randomized Phase 100 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813821|NCT02886884|BG004|Baseline|Total|Total of all reporting groups
10813822|NCT02886884|FG000|Participant Flow|Pilot Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813823|NCT02886884|FG001|Participant Flow|Pilot Phase 100 Million hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813824|NCT02886884|FG002|Participant Flow|Randomized Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813825|NCT02886884|FG003|Participant Flow|Randomized Phase 100 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813826|NCT02886884|OG000|Outcome|Pilot Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813827|NCT02886884|OG001|Outcome|Pilot Phase 100 Million hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813828|NCT02886884|OG002|Outcome|Randomized Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813829|NCT02886884|OG003|Outcome|Randomized Phase 100 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813830|NCT02886884|EG000|Reported Event|Pilot Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813831|NCT02886884|EG001|Reported Event|Pilot Phase 100 Million hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813832|NCT02886884|EG002|Reported Event|Randomized Phase 20 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813833|NCT02886884|EG003|Reported Event|Randomized Phase 100 Million Allogeneic hMSCs|"Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)~100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion"
10813834|NCT02845453|BG000|Baseline|Quetiapine|"Quetiapine~Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813835|NCT02845453|BG001|Baseline|Placebo|"Placebo~Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813836|NCT02845453|BG002|Baseline|Total|Total of all reporting groups
10813837|NCT02845453|FG000|Participant Flow|Quetiapine|"Quetiapine~Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813838|NCT02845453|FG001|Participant Flow|Placebo|"Placebo~Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813839|NCT02845453|OG000|Outcome|Quetiapine|"Quetiapine~Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813840|NCT02845453|OG001|Outcome|Placebo|"Placebo~Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813841|NCT02845453|EG000|Reported Event|Quetiapine|"Quetiapine~Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813842|NCT02845453|EG001|Reported Event|Placebo|"Placebo~Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study."
10813843|NCT02739542|BG000|Baseline|Tecfidera|"Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)~Tecfidera: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813844|NCT02739542|BG001|Baseline|Placebo|"Placebo by mouth twice daily.~Placebo: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813845|NCT02739542|BG002|Baseline|Total|Total of all reporting groups
10813846|NCT02739542|FG000|Participant Flow|Tecfidera|"Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)~Tecfidera: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813847|NCT02739542|FG001|Participant Flow|Placebo|"Placebo by mouth twice daily.~Placebo: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813848|NCT02739542|OG000|Outcome|Tecfidera|"Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)~Tecfidera: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813849|NCT02739542|OG001|Outcome|Placebo|"Placebo by mouth twice daily.~Placebo: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813850|NCT02739542|EG000|Reported Event|Tecfidera|"Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)~Tecfidera: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813851|NCT02739542|EG001|Reported Event|Placebo|"Placebo by mouth twice daily.~Placebo: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs."
10813852|NCT02717832|BG000|Baseline|Insulin Sensitivity|hyperinsulinemic-euglycemic clamp
10813853|NCT02717832|FG000|Participant Flow|Insulin Sensitivity|hyperinsulinemic-euglycemic clamp
10813854|NCT02717832|OG000|Outcome|Low Insulin Sensitivity Group|Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) < 400 nmol/kg fat free mass/min/(uU/ml Insulin)
10813855|NCT02717832|OG001|Outcome|High Insulin Sensitivity Group|Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) >550 nmol/kg fat free mass/min/(uU/ml Insulin)
10813856|NCT02717832|EG000|Reported Event|Insulin Sensitivity|hyperinsulinemic-euglycemic clamp
10821906|NCT00072449|OG000|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
10821907|NCT00072449|EG000|Reported Event|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
10821908|NCT00072475|BG000|Baseline|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
10821909|NCT00072475|FG000|Participant Flow|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
10821910|NCT00072475|OG000|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
10821911|NCT00072475|EG000|Reported Event|Vatalanib|After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
10821912|NCT00072514|BG000|Baseline|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
10821913|NCT00072514|FG000|Participant Flow|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
10821914|NCT00072514|OG000|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
10821915|NCT00072514|EG000|Reported Event|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
10821916|NCT00072566|BG000|Baseline|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
10821917|NCT00072566|FG000|Participant Flow|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
10821918|NCT00072566|OG000|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
10821919|NCT00072566|EG000|Reported Event|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
10821920|NCT00072761|BG000|Baseline|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
10821921|NCT00072761|BG001|Baseline|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
10821922|NCT00072761|BG002|Baseline|Total|Total of all reporting groups
10813857|NCT02677324|BG000|Baseline|ABT199|"ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles~ABT199: Oral BCL-2 antagonist"
10813858|NCT02677324|FG000|Participant Flow|ABT199|"ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles~ABT199: Oral BCL-2 antagonist"
10813859|NCT02677324|OG000|Outcome|ABT199|"ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles~ABT199: Oral BCL-2 antagonist"
10813860|NCT02677324|OG000|Outcome|CXCR4 Mutated Participants|Participants with the CXCR4 mutation detected at baseline bone marrow assessment
10813861|NCT02677324|OG000|Outcome|CXCR4 Wild-Type Participants|Participants who tested negative for a CXCR4 mutation at their baseline bone marrow assessment
10813862|NCT02677324|EG000|Reported Event|ABT199|"ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles~ABT199: Oral BCL-2 antagonist"
10813863|NCT02563028|BG000|Baseline|Evoked Response Photic Stimulator|"Arms~Assigned Interventions~Experimental: SightSaver Visual Stimulator~A SightSaver Visual Stimulator mask will be applied during surgery. Baseline VEPs will be recorded prior to prone positioning. At the end of surgery, after supine positioning, the SightSaver Visual Stimulator mask will be removed and discarded.~Device: SightSaver Visual Stimulator~Evoked response photic stimulator"
10813864|NCT02563028|FG000|Participant Flow|Intraoperative Monitoring Device|In this study, the FDA-cleared, non-invasive mask called SightSaverTM Visual Stimulator is used as an additional monitor to identify potential changes in the visual system during surgery
10813865|NCT02563028|OG000|Outcome|SightSaver Visual Stimulator|"A SightSaver Visual Stimulator mask will be applied during surgery. Baseline VEPs will be recorded prior to prone positioning. At the end of surgery, after supine positioning, the SightSaver Visual Stimulator mask will be removed and discarded.~SightSaver Visual Stimulator: Evoked response photic stimulator"
10813866|NCT02563028|EG000|Reported Event|SightSaver Visual Stimulator|"A SightSaver Visual Stimulator mask will be applied during surgery. Baseline VEPs will be recorded prior to prone positioning. At the end of surgery, after supine positioning, the SightSaver Visual Stimulator mask will be removed and discarded.~SightSaver Visual Stimulator: Evoked response photic stimulator~Adverse event total: 0/20 0%"
10813867|NCT02552212|BG000|Baseline|Placebo|Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.
11206212|NCT02233985|BG000|Baseline|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
10813868|NCT02552212|BG001|Baseline|CZP 200 mg Q2W|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
10813869|NCT02552212|BG002|Baseline|Total Title|
10813870|NCT02552212|FG000|Participant Flow|Placebo|Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.
10813871|NCT02552212|FG001|Participant Flow|CZP 200 mg Q2W|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
11206213|NCT02233985|BG001|Baseline|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
11206214|NCT02233985|BG002|Baseline|Total|Total of all reporting groups
10813872|NCT02552212|FG002|Participant Flow|SFE OL CZP 200 mg Q2W|Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during Safety Follow-Up Extension (SFE) Period. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
10813873|NCT02552212|OG000|Outcome|Placebo (FAS)|Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).
10813874|NCT02552212|OG001|Outcome|CZP 200 mg Q2W (FAS)|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the FAS.
10813875|NCT02552212|OG000|Outcome|Placebo (SS)|Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
10813876|NCT02552212|OG001|Outcome|CZP 200 mg Q2W (SS)|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
10813877|NCT02552212|OG000|Outcome|CZP 200 mg Q2W (SS)|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
10813878|NCT02552212|OG001|Outcome|Placebo->OL CZP (SS)|Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
10813879|NCT02552212|OG002|Outcome|Placebo->OL CZP (SS)|Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
10813880|NCT02552212|OG003|Outcome|CZP->OL CZP (SS)|Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
10821923|NCT00072761|FG000|Participant Flow|Transfusion Group|The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
10821924|NCT00072761|FG001|Participant Flow|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
10813881|NCT02552212|OG004|Outcome|SFE OL CZP 200 mg Q2W (SS)|Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
10813882|NCT02552212|EG000|Reported Event|Placebo (SS)|Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
10813883|NCT02552212|EG001|Reported Event|CZP 200 mg Q2W (SS)|Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
10813884|NCT02552212|EG002|Reported Event|Placebo->OL CZP (SS)|Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
10813885|NCT02552212|EG003|Reported Event|CZP->OL CZP (SS)|Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
10813886|NCT02552212|EG004|Reported Event|SFE OL CZP 200 mg Q2W (SS)|Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
10813887|NCT02439749|BG000|Baseline|Renal Denervation|"Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)~Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization."
10813888|NCT02439749|BG001|Baseline|Sham Procedure|"Renal angiography~Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal."
10813889|NCT02439749|BG002|Baseline|Total|Total of all reporting groups
10813890|NCT02439749|FG000|Participant Flow|Renal Denervation|"Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)~Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization."
10813891|NCT02439749|FG001|Participant Flow|Sham Procedure|"Renal angiography~Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal."
10813892|NCT02439749|OG000|Outcome|Renal Denervation|"Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)~Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization."
10813893|NCT02439749|OG001|Outcome|Sham Procedure|"Renal angiography~Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal."
10813894|NCT02439749|EG000|Reported Event|Renal Denervation|"Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)~Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization."
10813895|NCT02439749|EG001|Reported Event|Sham Procedure|"Renal angiography~Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal."
10813896|NCT02435511|BG000|Baseline|Control Arm|The control group will receive usual care, no HealtheRx.
10813897|NCT02435511|BG001|Baseline|Intervention Arm|"The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.~HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient."
10813898|NCT02435511|BG002|Baseline|Total|Total of all reporting groups
10813899|NCT02435511|FG000|Participant Flow|Control Arm|The control group will receive usual care, no HealtheRx.
10813900|NCT02435511|FG001|Participant Flow|Intervention Arm|"The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.~HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient."
10813901|NCT02435511|OG000|Outcome|Control Arm|The control group will receive usual care, no HealtheRx.
10821925|NCT00072761|OG000|Outcome|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
11206215|NCT02233985|FG000|Participant Flow|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
11244342|NCT02510001|OG000|Outcome|Dose Escalation Phase Binimetinib/PF-02341066|All of the patients registered for this escalation phase are included in this progression free analysis, to preliminarily assess the efficacy of the drug combination.
10813902|NCT02435511|OG001|Outcome|Intervention Arm|"The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.~HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient."
10813903|NCT02435511|EG000|Reported Event|Control Arm|The control group will receive usual care, no HealtheRx.
10813904|NCT02435511|EG001|Reported Event|Intervention Arm|"The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.~HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient."
10813905|NCT02411448|BG000|Baseline|Part A: Ramucirumab + Erlotinib|"Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813906|NCT02411448|BG001|Baseline|Part B: Ramucirumab+ Erlotinib|"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813907|NCT02411448|BG002|Baseline|Part B: Placebo+ Erlotinib|"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813908|NCT02411448|BG003|Baseline|Total|Total of all reporting groups
10813909|NCT02411448|FG000|Participant Flow|Part A: Ramucirumab + Erlotinib|"Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813910|NCT02411448|FG001|Participant Flow|Part B: Ramucirumab+ Erlotinib|"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813911|NCT02411448|FG002|Participant Flow|Part B: Placebo+ Erlotinib|"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813912|NCT02411448|OG000|Outcome|Part B: Ramucirumab+ Erlotinib|"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813913|NCT02411448|OG001|Outcome|Part B: Placebo+ Erlotinib|"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813914|NCT02411448|OG000|Outcome|Part A: Ramucirumab + Erlotinib|"Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813915|NCT02411448|OG001|Outcome|Part B: Ramucirumab + Erlotinib|"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813916|NCT02411448|OG002|Outcome|Part B: Placebo + Erlotinib|"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813917|NCT02411448|OG000|Outcome|Part B: Ramucirumab+ Erlotinib|"Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813918|NCT02411448|OG001|Outcome|Part B: Placebo+ Erlotinib|"Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813919|NCT02411448|EG000|Reported Event|Part A: Ramucirumab + Erlotinib|"Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813920|NCT02411448|EG001|Reported Event|Part B: Ramucirumab + Erlotinib|"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813921|NCT02411448|EG002|Reported Event|Part B: Placebo + Erlotinib|"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.~Participants may continue to receive treatment until discontinuation criteria are met."
10813922|NCT02371369|BG000|Baseline|Pexidartinib Part 1, Then Pexidartinib Part 2|"Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813923|NCT02371369|BG001|Baseline|Placebo Part 1, Then Pexidartinib Part 2|"Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.~Placebo: Placebo capsule matching pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration (Part 2)."
10813924|NCT02371369|BG002|Baseline|Total|Total of all reporting groups
10813925|NCT02371369|FG000|Participant Flow|Pexidartinib Part 1, Then Pexidartinib Part 2|"Participants received Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration."
10821926|NCT00072761|OG001|Outcome|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
11206216|NCT02233985|FG001|Participant Flow|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
10821927|NCT00072761|EG000|Reported Event|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
10821928|NCT00072761|EG001|Reported Event|Observation Group|The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
10821929|NCT00073008|BG000|Baseline|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
10821930|NCT00073008|BG001|Baseline|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
10813926|NCT02371369|FG001|Participant Flow|Placebo Part 1, Then Pexidartinib Part 2|"Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 of study. Eligible participants from this group also received Pexidartinib in Part 2 at their prescribed dose.~Placebo: Placebo capsule matching Pexidartinib capsule for oral administration. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration (Part 2)."
10813927|NCT02371369|OG000|Outcome|Pexidartinib Part 1|Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
10813928|NCT02371369|OG001|Outcome|Placebo Part 1|Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
10813929|NCT02371369|OG000|Outcome|Pexidartinib Part 1|"Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks~Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration."
10813930|NCT02371369|OG001|Outcome|Placebo Part 1|"Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks~Placebo: Placebo capsule matching Pexidartinib capsule for oral administration."
10813931|NCT02371369|OG000|Outcome|Pexidartinib Part 1 and Part 2|"Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks~Part 2: Participants also received pexidartinib at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813932|NCT02371369|OG001|Outcome|Placebo Part 1, Pexidartinib Part 2|"Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813933|NCT02371369|OG002|Outcome|All Pexidartinib Treated|All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
10813934|NCT02371369|OG000|Outcome|Pexidartinib in Part 1 and Part 2|"Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813935|NCT02371369|OG001|Outcome|Placebo Part 1, Pexidartinib Part 2|"Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.~Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration."
10813936|NCT02371369|OG002|Outcome|All Pexidartinib Treated|All participants who received pexidartinib in Part 1 and Part 2 as well as those who received pexidartinib in Part 2 only.
10813937|NCT02371369|OG000|Outcome|Pexidartinib Part 1 and Part 2|"Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813938|NCT02371369|OG002|Outcome|Pexidartinib Part 1 and Part 2|"Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration."
10813939|NCT02371369|OG003|Outcome|Placebo Part 1, Pexidartinib Part 2|"Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose.~Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration."
10813940|NCT02371369|OG004|Outcome|All Pexidartinib Treated|All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
10813941|NCT02371369|OG000|Outcome|Pexidartinib Part 1 and Part 2|"Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose.~Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration."
10813942|NCT02371369|EG000|Reported Event|Pexidartinib (Part 1)|"Participants received blinded treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813943|NCT02371369|EG001|Reported Event|Placebo (Part 1)|"Participants received blinded treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks~Placebo: Placebo capsule matching pexidartinib capsule for oral administration"
10813944|NCT02371369|EG002|Reported Event|Pexidartinib (Parts 1 and 2)|"Participants received pexidartinib in Part 1 and in Part 2 at their prescribed dose~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration"
10813945|NCT02371369|EG003|Reported Event|Placebo (Part 1), Crossover Pexidartinib (Part 2)|"Participants received placebo in Part 1 and pexidartinib in Part 2 at their prescribed dose~Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration~Placebo: Placebo capsule matching pexidartinib capsule for oral administration"
10813946|NCT02371369|EG004|Reported Event|All Pexidartinib Treated|All participants who received pexidartinib in Part 1 and Part 2 (placebo crossed over to pexidartinib)
10813947|NCT02282917|BG000|Baseline|AR-42 Administration|AR-42 was administered three times per week beginning 3 weeks prior to surgery. AR-42 was administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, and was self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. A study investigator performed the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.
10821931|NCT00073008|BG002|Baseline|Total|Total of all reporting groups
10821932|NCT00073008|FG000|Participant Flow|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
10821933|NCT00073008|FG001|Participant Flow|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
10821934|NCT00073008|OG000|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
10813948|NCT02282917|FG000|Participant Flow|AR-42 Administration|There was no randomization in this trial and all participants completed study procedures uniformly. AR-42 was administered three times per week beginning 3 weeks prior to surgery. AR-42 was administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, which was self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. All participants were instructed to take the study medication at least 1 hour before, or 2 hours after, a meal. The principal investigator performed the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.
10813949|NCT02282917|OG000|Outcome|AR-42 Administration|There was no randomization in this trial and all participants completed study procedures uniformly. AR-42 was administered three times per week beginning 3 weeks prior to surgery. AR-42 was administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, which was self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. All participants were instructed to take the study medication at least 1 hour before, or 2 hours after, a meal. The principal investigator performed the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.
10813950|NCT02282917|EG000|Reported Event|AR-42 Administration|AR-42 was administered three times per week beginning 3 weeks prior to surgery. AR-42 was administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, and was self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. A study investigator performed the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.
10813951|NCT01849783|BG000|Baseline|Autologous Stem Cell Transplant|"Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)~Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.~dexamethasone: Given PO~cisplatin: Given IV~doxorubicin: Given IV~cyclophosphamide: Given IV or PO~etoposide: Given IV~bortezomib: Given IV~thalidomide: Given PO~melphalan: Given IV~autologous stem cell transplant"
10813952|NCT01849783|FG000|Participant Flow|Autologous Stem Cell Transplant|"Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)~Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.~dexamethasone: Given PO~cisplatin: Given IV~doxorubicin: Given IV~cyclophosphamide: Given IV or PO~etoposide: Given IV~bortezomib: Given IV~thalidomide: Given PO~melphalan: Given IV~autologous stem cell transplant"
10813953|NCT01849783|OG000|Outcome|Autologous Stem Cell Transplant|"Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)~Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.~dexamethasone: Given PO~cisplatin: Given IV~doxorubicin: Given IV~cyclophosphamide: Given IV or PO~etoposide: Given IV~bortezomib: Given IV~thalidomide: Given PO~melphalan: Given IV~autologous stem cell transplant"
10813954|NCT01849783|EG000|Reported Event|D-PACE/Induction|Initial chemotherapy will consist of 1 cycle of combination D-PACE chemotherapy and peripheral blood stem cell collection.
10813955|NCT01849783|EG001|Reported Event|Post D-PACE/Pre-Transplant|Following D-PACE and Peripheral Blood Stem Cell (PBSC) collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days, but this may be omitted by the treating physician
10813956|NCT01849783|EG002|Reported Event|Transplant|Transplant should preferably occur 6 weeks after the induction PACE continuous infusion has been completed, but can occur as early as 4 weeks and as late as 3 months if the participant fails to mobilize stem cells after the PACE administration
10813957|NCT01849783|EG003|Reported Event|Post-transplant/Consolidation|"Participants will receive dexamethasone 20 mg oral days 1-4 every 21 days and thalidomide 100 mg oral and daily in the interim between transplant and consolidation.~If administered, post-transplant consolidation therapy should begin 4-6 weeks after transplant, but should occur no later than 4 months after transplant. Consolidation will consist of one cycle of VDT-PACE."
10813958|NCT01849783|EG004|Reported Event|Maintenance Therapy, Year 1|Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
10813959|NCT01849783|EG005|Reported Event|Maintenance Therapy, Year 2|Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
10813960|NCT01849783|EG006|Reported Event|Long Term Follow-up|Study participants will be evaluated at the study center at least once per year.
10813961|NCT01741480|BG000|Baseline|Routine Care|"General hospital ward patients will receive routine care.~routine care"
10813962|NCT01741480|BG001|Baseline|Intervention Arm|"Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.~Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University."
10813963|NCT01741480|BG002|Baseline|Total|Total of all reporting groups
10813964|NCT01741480|FG000|Participant Flow|Routine Care|"General hospital ward patients will receive routine care.~routine care =286"
10813965|NCT01741480|FG001|Participant Flow|Intervention Arm|"Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.~Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285"
10813966|NCT01741480|OG000|Outcome|Routine Care|"General hospital ward patients will receive routine care.~routine care =286"
10813967|NCT01741480|OG001|Outcome|Intervention Arm|"Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.~Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285"
10813968|NCT01741480|EG000|Reported Event|Routine Care|"General hospital ward patients will receive routine care.~routine care =286"
10813969|NCT01741480|EG001|Reported Event|Intervention Arm|"Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.~Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285"
10813970|NCT01737021|BG000|Baseline|Psycho-educational Intervention|Received psycho-educational intervention.
10813971|NCT01737021|BG001|Baseline|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
10813972|NCT01737021|BG002|Baseline|Total|Total of all reporting groups
10813973|NCT01737021|FG000|Participant Flow|Psycho-educational Intervention|"Psycho-education~Psycho-education: The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate."
10813974|NCT01737021|FG001|Participant Flow|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
10813975|NCT01737021|OG000|Outcome|Intervention|There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.
10813976|NCT01737021|OG001|Outcome|Study Design|There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
10813977|NCT01737021|EG000|Reported Event|Psycho-educational Intervention|Received psycho-educational intervention.
10813978|NCT01737021|EG001|Reported Event|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
10813979|NCT01505465|BG000|Baseline|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
10813980|NCT01505465|BG001|Baseline|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
10813981|NCT01505465|BG002|Baseline|Total|Total of all reporting groups
10813982|NCT01505465|FG000|Participant Flow|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
10813983|NCT01505465|FG001|Participant Flow|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
10813984|NCT01505465|OG000|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
10813985|NCT01505465|OG001|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
10813986|NCT01505465|EG000|Reported Event|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
10813987|NCT01505465|EG001|Reported Event|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
10813988|NCT01333943|BG000|Baseline|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813989|NCT01333943|BG001|Baseline|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813990|NCT01333943|BG002|Baseline|Total|Total of all reporting groups
10813991|NCT01333943|FG000|Participant Flow|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813992|NCT01333943|FG001|Participant Flow|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813993|NCT01333943|OG000|Outcome|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10821935|NCT00073008|OG001|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
10821936|NCT00073008|EG000|Reported Event|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
10813994|NCT01333943|OG001|Outcome|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813995|NCT01333943|EG000|Reported Event|Experimental|"Saphenous (Adductor Canal) Nerve Block~Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813996|NCT01333943|EG001|Reported Event|Control|"Femoral Nerve Block~Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg)."
10813997|NCT01322646|BG000|Baseline|Driver Training|"Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~Driving Simulator Practice: Practice Driving on a driving simulator"
10813998|NCT01322646|BG001|Baseline|STEER Program|"Driver Education STEER Program~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~STEER Program: 8-session behavioral parent training and teen social skills/communication training program~Driving Simulator Practice: Practice Driving on a driving simulator"
10813999|NCT01322646|BG002|Baseline|Total|Total of all reporting groups
10814000|NCT01322646|FG000|Participant Flow|Driver Training|"Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~Driving Simulator Practice: Practice Driving on a driving simulator"
10814001|NCT01322646|FG001|Participant Flow|STEER Program|"Driver Education STEER Program~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~STEER Program: 8-session behavioral parent training and teen social skills/communication training program~Driving Simulator Practice: Practice Driving on a driving simulator"
10814002|NCT01322646|OG000|Outcome|Driver Training|"Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~Driving Simulator Practice: Practice Driving on a driving simulator"
10814003|NCT01322646|OG001|Outcome|STEER Program|"Driver Education STEER Program~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~STEER Program: 8-session behavioral parent training and teen social skills/communication training program~Driving Simulator Practice: Practice Driving on a driving simulator"
10814004|NCT01322646|EG000|Reported Event|Driver Training|"Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~Driving Simulator Practice: Practice Driving on a driving simulator"
10814005|NCT01322646|EG001|Reported Event|STEER Program|"Driver Education STEER Program~CarChipPro: On board driving monitor~Driver's Education: 10 Session License to Learn Program.~STEER Program: 8-session behavioral parent training and teen social skills/communication training program~Driving Simulator Practice: Practice Driving on a driving simulator"
10814006|NCT01090024|BG000|Baseline|Overall Population|All of the enrolled participants that were randomized to one of the treatment sequences for 3 × 4-week treatment periods and treated with at least one dose of study drug.
10814007|NCT01090024|FG000|Participant Flow|Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 400mg PM QD (C)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814008|NCT01090024|FG001|Participant Flow|Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 200 mg BID (D)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10814009|NCT01090024|FG002|Participant Flow|Placebo(A)/BI 671800 400mg PM QD (C)/BI 671800 400mg AM QD (B)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10821937|NCT00073008|EG001|Reported Event|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
10821938|NCT00073021|BG000|Baseline|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
10821939|NCT00073021|BG001|Baseline|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
10821940|NCT00073021|BG002|Baseline|Total|Total of all reporting groups
11206217|NCT02233985|OG000|Outcome|Hypertonic Saline Solution 3% (HSS 3%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
11244343|NCT02510001|OG000|Outcome|Dose Escalation Phase Binimetinib/PF-02341066|All of the patients registered for this escalation phase are included in this survival analysis, to preliminarily assess the efficacy of the drug combination.
11206218|NCT02233985|OG001|Outcome|Saline Solution 0.9% (SS 0.9%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
11206219|NCT02233985|OG000|Outcome|Hypertonic Saline Solution 3% (SHS 3%)|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
11206220|NCT02233985|OG001|Outcome|Saline Solution 0.9% (SS 0.9%) Group|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
10814010|NCT01090024|FG003|Participant Flow|Placebo (A)/BI 671800 400mg PM QD (C)/BI 671800 200 mg BID (D)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10814011|NCT01090024|FG004|Participant Flow|Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10814012|NCT01090024|FG005|Participant Flow|Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814013|NCT01090024|FG006|Participant Flow|BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 400 mg PM QD(C)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814014|NCT01090024|FG007|Participant Flow|BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 200 mg BID(D)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10814015|NCT01090024|FG008|Participant Flow|BI 671800 400 mg AM QD(B)/BI 671800 400 mg PM QD(C)/Placebo(A)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814016|NCT01090024|FG009|Participant Flow|BI 671800 400 mg AM QD(B)/BI 671800 200 mg BID(D)/Placebo(A)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814017|NCT01090024|FG010|Participant Flow|BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 400 mg AM QD(B)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10814018|NCT01090024|FG011|Participant Flow|BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 200 mg BID(D)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10821941|NCT00073021|FG000|Participant Flow|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
10821942|NCT00073021|FG001|Participant Flow|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
10821943|NCT00073021|OG000|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
10814019|NCT01090024|FG012|Participant Flow|BI 671800 400 mg PM QD(C)/BI 671800 400 mg AM QD(B)/Placebo(A)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814020|NCT01090024|FG013|Participant Flow|BI 671800 400 mg PM QD(C)/BI 671800 200 mg BID(D)/Placebo(A)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814021|NCT01090024|FG014|Participant Flow|BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg AM QD(B)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10814022|NCT01090024|FG015|Participant Flow|BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg PM QD(C)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814023|NCT01090024|FG016|Participant Flow|BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)/Placebo(A)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814024|NCT01090024|FG017|Participant Flow|BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)/Placebo(A)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814025|NCT01090024|OG000|Outcome|Placebo (A)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814026|NCT01090024|OG001|Outcome|BI 671800 400mg AM QD (B)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10814027|NCT01090024|OG002|Outcome|BI 671800 400mg PM QD (C)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814028|NCT01090024|OG003|Outcome|BI 671800 200mg BID (D)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10814029|NCT01090024|EG000|Reported Event|Placebo (A)|(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
10814030|NCT01090024|EG001|Reported Event|BI 671800 400mg AM QD (B)|(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
10814031|NCT01090024|EG002|Reported Event|BI 671800 400mg PM QD (C)|(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
10814032|NCT01090024|EG003|Reported Event|BI 671800 200mg BID (D)|(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
10821944|NCT00073021|OG001|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
10821945|NCT00073021|EG000|Reported Event|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
10821946|NCT00073021|EG001|Reported Event|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
10814037|NCT00943722|BG000|Baseline|Base Study: 9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814038|NCT00943722|BG001|Baseline|Base Study: 9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
10814039|NCT00943722|BG002|Baseline|Base Study: 9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
10814040|NCT00943722|BG003|Baseline|Base Study: 9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814041|NCT00943722|BG004|Baseline|Base Study: 16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814042|NCT00943722|BG005|Baseline|Total|Total of all reporting groups
10814043|NCT00943722|FG000|Participant Flow|Base Study: 9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814044|NCT00943722|FG001|Participant Flow|Base Study: 9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
10814045|NCT00943722|FG002|Participant Flow|Base Study: 9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
10814046|NCT00943722|FG003|Participant Flow|Base Study: 9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814047|NCT00943722|FG004|Participant Flow|Base Study: 16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814048|NCT00943722|FG005|Participant Flow|Extension Study: 9- to 15-Year-Old Females|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
10814049|NCT00943722|FG006|Participant Flow|Extension Study: 9- to 15-Year-Old Males|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
10814050|NCT00943722|OG000|Outcome|Base Study: 9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814051|NCT00943722|OG001|Outcome|Base Study: 9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814052|NCT00943722|OG000|Outcome|Base Study: 9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814053|NCT00943722|OG001|Outcome|Base Study: 16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814054|NCT00943722|OG001|Outcome|Base Study: 9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
10814055|NCT00943722|OG002|Outcome|Base Study: 9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
10814056|NCT00943722|OG000|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
10814057|NCT00943722|OG002|Outcome|Base Study: 16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814058|NCT00943722|OG000|Outcome|9- to 15-Year-Old Females (Lots 1, 2, or 3)|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
10814059|NCT00943722|OG000|Outcome|Extension Study: 9- to 15-Year-Old Females|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
10814060|NCT00943722|OG001|Outcome|Extension Study: 9- to 15-Year-Old Males|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
10814061|NCT00943722|OG000|Outcome|Extension Study: 9- to 15-Year-Old Males|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
10814062|NCT00943722|EG000|Reported Event|Base Study: 9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814063|NCT00943722|EG001|Reported Event|Base Study: 9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
10814064|NCT00943722|EG002|Reported Event|Base Study: 9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
10814065|NCT00943722|EG003|Reported Event|Base Study: 9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814066|NCT00943722|EG004|Reported Event|Base Study: 16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
10814067|NCT00943722|EG005|Reported Event|EXT1: 9- to 15-Year-Old Females|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
10814068|NCT00943722|EG006|Reported Event|EXT1: 9- to 15-Year-Old Males|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
10814069|NCT00943722|EG007|Reported Event|EXT2: 9- to 15-Year-Old Females|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
10814070|NCT00943722|EG008|Reported Event|EXT2: 9- to 15-Year-Old Males|In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
10814071|NCT00676663|BG000|Baseline|Exemestane 25 mg + Placebo|Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814072|NCT00676663|BG001|Baseline|Exemestane 25 mg + Entinostat 5 mg|Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814073|NCT00676663|BG002|Baseline|Total|Total of all reporting groups
10814074|NCT00676663|FG000|Participant Flow|Exemestane 25 mg + Placebo|Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814075|NCT00676663|FG001|Participant Flow|Exemestane 25 mg + Entinostat 5 mg|Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814076|NCT00676663|OG000|Outcome|Exemestane 25 mg + Placebo|Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814077|NCT00676663|OG001|Outcome|Exemestane 25 mg + Entinostat 5 mg|Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814078|NCT00676663|OG000|Outcome|Exemestane 25 mg + Placebo (EP)|Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814079|NCT00676663|OG001|Outcome|Exemestane 25 mg + Entinostat 5 mg (EE)|Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814080|NCT00676663|EG000|Reported Event|Exemestane 25 mg + Placebo|Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814081|NCT00676663|EG001|Reported Event|Exemestane 25 mg + Entinostat 5 mg|Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
10814082|NCT00391365|BG000|Baseline|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10814083|NCT00391365|BG001|Baseline|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10814084|NCT00391365|BG002|Baseline|Total|Total of all reporting groups
10814085|NCT00391365|FG000|Participant Flow|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10814086|NCT00391365|FG001|Participant Flow|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10814087|NCT00391365|OG000|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
10814088|NCT00391365|OG001|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
10814089|NCT00391365|OG001|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
10814090|NCT00391365|EG000|Reported Event|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10814091|NCT00391365|EG001|Reported Event|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
10821947|NCT00073073|BG000|Baseline|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
10821948|NCT00073073|FG000|Participant Flow|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
10821949|NCT00073073|OG000|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
10821950|NCT00073073|EG000|Reported Event|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
10821951|NCT00073307|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
10821952|NCT00073307|BG001|Baseline|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
10821953|NCT00073307|BG002|Baseline|Total|Total of all reporting groups
10821954|NCT00073307|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
10821955|NCT00073307|FG001|Participant Flow|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
10821956|NCT00073307|FG002|Participant Flow|Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only|Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
10821957|NCT00073307|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
10821958|NCT00073307|OG001|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
10821959|NCT00073307|OG001|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
10821960|NCT00073307|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)-31May2005 DB|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
10821961|NCT00073307|EG001|Reported Event|Placebo-31May2005 DB|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
10821962|NCT00073307|EG002|Reported Event|Sorafenib (Nexavar, BAY43-9006)-30Jun2008|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
10821963|NCT00073307|EG003|Reported Event|Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008|Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
10821964|NCT00073333|BG000|Baseline|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
10821965|NCT00073333|BG001|Baseline|2Imaginal and in Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
10821966|NCT00073333|BG002|Baseline|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
10821967|NCT00073333|BG003|Baseline|Total|Total of all reporting groups
10821968|NCT00073333|FG000|Participant Flow|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.
10821969|NCT00073333|FG001|Participant Flow|2Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice
10821970|NCT00073333|FG002|Participant Flow|3Attention Placebo|Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
10821971|NCT00073333|OG000|Outcome|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
10821972|NCT00073333|OG001|Outcome|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
10814092|NCT04617860|BG000|Baseline|4 mg WVE-120102|Enrolled at 4 mg WVE-120102 dose level
10814093|NCT04617860|BG001|Baseline|8 mg WVE-120102|Enrolled at 8 mg WVE-120102 dose level
10814094|NCT04617860|BG002|Baseline|16 mg WVE-120102|Enrolled at 16 mg WVE-120102 dose level
10814095|NCT04617860|BG003|Baseline|Total|Total of all reporting groups
10814096|NCT04617860|FG000|Participant Flow|4 mg WVE-120102|Enrolled at 4 mg WVE-120102 dose level
10814097|NCT04617860|FG001|Participant Flow|8 mg WVE-120102|Enrolled at 8 mg WVE-120102 dose level
10814098|NCT04617860|FG002|Participant Flow|16 mg WVE-120102|Enrolled at 16 mg WVE-120102 dose level
10814099|NCT04617860|OG000|Outcome|4 mg WVE-120102|Received 4 mg WVE-120102 at any point in the study
10814100|NCT04617860|OG001|Outcome|8 mg WVE-120102|Received 8 mg WVE-120102 at any point in the study
10814101|NCT04617860|OG002|Outcome|16 mg WVE-120102|Received 16 mg WVE-120102 at any point in the study
10814102|NCT04617860|OG003|Outcome|32 mg WVE-120102|Received 32 mg WVE-120102 at any point in the study
10814103|NCT04617860|EG000|Reported Event|4 mg WVE-120102|Received 4 mg WVE-120102 at any point in the study
10814104|NCT04617860|EG001|Reported Event|8 mg WVE-120102|Received 8 mg WVE-120102 at any point in the study
10814105|NCT04617860|EG002|Reported Event|16 mg WVE-120102|Received 16 mg WVE-120102 at any point in the study
10814106|NCT04617860|EG003|Reported Event|32 mg WVE-120102|Received 32 mg WVE-120102 at any point in the study
10814107|NCT04617847|BG000|Baseline|4 mg WVE-120101|Enrolled at 4 mg WVE-120101 dose level
10814108|NCT04617847|BG001|Baseline|16 mg WVE-120101|Enrolled at 12 mg WVE-120101 dose level
10814109|NCT04617847|BG002|Baseline|Total|Total of all reporting groups
10814110|NCT04617847|FG000|Participant Flow|4 mg WVE-120101|Enrolled at 4 mg WVE-120101 dose level
10814111|NCT04617847|FG001|Participant Flow|16 mg WVE-120101|Enrolled at 16 mg WVE-120101 dose level
10814112|NCT04617847|OG000|Outcome|4 mg WVE-120101|Patients who received 4 mg WVE-120101 at any point in the study
10814113|NCT04617847|OG001|Outcome|16 mg WVE-120101|Patients who received 16 mg WVE-120101 at any point in the study
10814114|NCT04617847|OG002|Outcome|32 mg WVE-120101|Patients who received 32 mg WVE-120101 at any point in the study
10814115|NCT04617847|EG000|Reported Event|4 mg WVE-120101|Patients who received 4 mg WVE-120101 at any point in the study
10814116|NCT04617847|EG001|Reported Event|16 mg WVE-120101|Patients who received 16 mg WVE-120101 at any point in the study
10814117|NCT04617847|EG002|Reported Event|32 mg WVE-120101|Patients who received 32 mg WVE-120101 at any point in the study
10814127|NCT04063657|BG000|Baseline|External Fixation|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.~External fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814128|NCT04063657|BG001|Baseline|Splinting|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.~Splinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814129|NCT04063657|BG002|Baseline|Total|Total of all reporting groups
10814130|NCT04063657|FG000|Participant Flow|External Fixation|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.~External fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814131|NCT04063657|FG001|Participant Flow|Splinting|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.~Splinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814132|NCT04063657|OG000|Outcome|External Fixation|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.~External fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814133|NCT04063657|OG001|Outcome|Splinting|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.~Splinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814134|NCT04063657|EG000|Reported Event|External Fixation|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.~External fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814135|NCT04063657|EG001|Reported Event|Splinting|"Adults diagnosed with an acute (<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.~Splinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery."
10814136|NCT04042623|BG000|Baseline|Treatment With AVB-S6-500|The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
10814137|NCT04042623|FG000|Participant Flow|Treatment With AVB-S6-500|The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
10814138|NCT04042623|OG000|Outcome|Treatment With AVB-S6-500|The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
11206221|NCT02233985|EG000|Reported Event|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
10814118|NCT04426318|BG000|Baseline|Healthy Minds Program Foundations Training|Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
10814119|NCT04426318|BG001|Baseline|Wait-list Control|Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
10814120|NCT04426318|BG002|Baseline|Total|Total of all reporting groups
10814121|NCT04426318|FG000|Participant Flow|Healthy Minds Program Foundations Training|Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
10814122|NCT04426318|FG001|Participant Flow|Wait-list Control|Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
10814123|NCT04426318|OG000|Outcome|Healthy Minds Program Foundations Training|Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
10814124|NCT04426318|OG001|Outcome|Wait-list Control|Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
10814125|NCT04426318|EG000|Reported Event|Healthy Minds Program Foundations Training|Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
10814126|NCT04426318|EG001|Reported Event|Wait-list Control|Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
10814139|NCT04042623|EG000|Reported Event|Treatment With AVB-S6-500|The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
10814140|NCT03882047|BG000|Baseline|Mometasone Furoate Nasal Spray|Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814141|NCT03882047|BG001|Baseline|Fluticasone Propionate Nasal Spray|Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
10814142|NCT03882047|BG002|Baseline|Placebo Nasal Spray|Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814143|NCT03882047|BG003|Baseline|Total|Total of all reporting groups
10814144|NCT03882047|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814145|NCT03882047|FG001|Participant Flow|Fluticasone Propionate Nasal Spray|Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
10814146|NCT03882047|FG002|Participant Flow|Placebo Nasal Spray|Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814147|NCT03882047|OG000|Outcome|Mometasone Furoate Nasal Spray|Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814148|NCT03882047|OG001|Outcome|Fluticasone Propionate Nasal Spray|Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
10814149|NCT03882047|OG002|Outcome|Placebo Nasal Spray|Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814150|NCT03882047|EG000|Reported Event|Mometasone Furoate Nasal Spray|Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814151|NCT03882047|EG001|Reported Event|Fluticasone Propionate Nasal Spray|Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
10814152|NCT03882047|EG002|Reported Event|Placebo Nasal Spray|Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
10814153|NCT03879772|BG000|Baseline|MFNS 25 mcg QD|Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10967073|NCT00891176|OG002|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10967074|NCT00891176|OG003|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10967075|NCT00891176|OG000|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10814154|NCT03879772|BG001|Baseline|MFNS 100 mcg QD|Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814155|NCT03879772|BG002|Baseline|MFNS 200 mcg QD|Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814156|NCT03879772|BG003|Baseline|BDP 84 mcg BID|Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814157|NCT03879772|BG004|Baseline|Placebo|Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814158|NCT03879772|BG005|Baseline|Total|Total of all reporting groups
10814159|NCT03879772|FG000|Participant Flow|MFNS 25 mcg QD|Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814160|NCT03879772|FG001|Participant Flow|MFNS 100 mcg QD|Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814161|NCT03879772|FG002|Participant Flow|MFNS 200 mcg QD|Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814162|NCT03879772|FG003|Participant Flow|BDP 84 mcg BID|Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814163|NCT03879772|FG004|Participant Flow|Placebo|Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814164|NCT03879772|OG000|Outcome|MFNS 25 mcg QD|Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814165|NCT03879772|OG001|Outcome|MFNS 100 mcg QD|Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814166|NCT03879772|OG002|Outcome|MFNS 200 mcg QD|Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814167|NCT03879772|OG003|Outcome|BDP 84 mcg BID|Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814168|NCT03879772|OG004|Outcome|Placebo|Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814169|NCT03879772|EG000|Reported Event|MFNS 25 mcg QD|Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814170|NCT03879772|EG001|Reported Event|MFNS 100 mcg QD|Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814171|NCT03879772|EG002|Reported Event|MFNS 200 mcg QD|Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814172|NCT03879772|EG003|Reported Event|BDP 84 mcg BID|Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814173|NCT03879772|EG004|Reported Event|Placebo|Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
10814174|NCT03861559|BG000|Baseline|Mometasone Furoate Nasal Spray|Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.
10814175|NCT03861559|BG001|Baseline|Placebo Nasal Spray|Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
10814176|NCT03861559|BG002|Baseline|Total|Total of all reporting groups
10814177|NCT03861559|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.
10814178|NCT03861559|FG001|Participant Flow|Placebo Nasal Spray|Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
10814179|NCT03861559|OG000|Outcome|Mometasone Furoate Nasal Spray|Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.
10814180|NCT03861559|OG001|Outcome|Placebo Nasal Spray|Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
10814181|NCT03861559|EG000|Reported Event|Mometasone Furoate Nasal Spray|Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.
10814182|NCT03861559|EG001|Reported Event|Placebo Nasal Spray|Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
10814183|NCT03855228|BG000|Baseline|MFNS 200 μg + Loratadine 10 mg|Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
10814184|NCT03855228|BG001|Baseline|MFNS 200 μg|Daily administration of 200 μg of MFNS plus oral placebo tablet.
10814185|NCT03855228|BG002|Baseline|Loratadine 10 mg|Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
10814186|NCT03855228|BG003|Baseline|Placebo|Daily administration of placebo nasal spray plus oral placebo tablet.
10814187|NCT03855228|BG004|Baseline|Total|Total of all reporting groups
10814188|NCT03855228|FG000|Participant Flow|MFNS 200 μg + Loratadine 10 mg|Daily administration of 200 μg of Mometasone Furoate Nasal Spray (MFNS) plus oral dose of 10 mg loratadine tablet.
10814189|NCT03855228|FG001|Participant Flow|MFNS 200 μg|Daily administration of 200 μg of MFNS plus oral placebo tablet.
10814190|NCT03855228|FG002|Participant Flow|Loratadine 10 mg|Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
10814191|NCT03855228|FG003|Participant Flow|Placebo|Daily administration of placebo nasal spray plus oral placebo tablet.
10814192|NCT03855228|OG000|Outcome|MFNS 200 μg + Loratadine 10 mg|Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
10814193|NCT03855228|OG001|Outcome|MFNS 200 μg|Daily administration of 200 μg of MFNS plus oral placebo tablet.
10814194|NCT03855228|OG002|Outcome|Loratadine 10 mg|Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
10814195|NCT03855228|OG003|Outcome|Placebo|Daily administration of placebo nasal spray plus oral placebo tablet.
10814196|NCT03855228|EG000|Reported Event|MFNS Pus Loratadine|Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
10814197|NCT03855228|EG001|Reported Event|MFNS 200|Daily administration of 200 μg of MFNS plus oral placebo tablet.
10814198|NCT03855228|EG002|Reported Event|Loratadine|Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
10814199|NCT03855228|EG003|Reported Event|Placebo|Daily administration of placebo nasal spray plus oral placebo tablet.
10814200|NCT03855189|BG000|Baseline|Mometasone Furoate (MF)|Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
10814201|NCT03855189|BG001|Baseline|Beclomethasone Dipropionate (BDP)|Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
10814202|NCT03855189|BG002|Baseline|Placebo|Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
10814203|NCT03855189|BG003|Baseline|Total|Total of all reporting groups
10814204|NCT03855189|FG000|Participant Flow|Mometasone Furoate (MF)|Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
10814205|NCT03855189|FG001|Participant Flow|Beclomethasone Dipropionate (BDP)|Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
10814206|NCT03855189|FG002|Participant Flow|Placebo|Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
10814207|NCT03855189|OG000|Outcome|Mometasone Furoate (MF)|Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
10814208|NCT03855189|OG001|Outcome|Beclomethasone Dipropionate (BDP)|Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
10814209|NCT03855189|OG002|Outcome|Placebo|Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
10814210|NCT03855189|EG000|Reported Event|Mometasone Furoate (MF)|Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
10814211|NCT03855189|EG001|Reported Event|Beclomethasone Dipropionate (BDP)|Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
10814212|NCT03855189|EG002|Reported Event|Placebo|Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
10814213|NCT03764631|BG000|Baseline|Empagliflozin|Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814214|NCT03764631|BG001|Baseline|DPP-4 Inhibitors|Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814215|NCT03764631|BG002|Baseline|Total|Total of all reporting groups
10821973|NCT00073333|OG002|Outcome|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
10814216|NCT03764631|FG000|Participant Flow|Empagliflozin|Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814217|NCT03764631|FG001|Participant Flow|DPP-4 Inhibitors|Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814218|NCT03764631|OG000|Outcome|Empagliflozin|Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814219|NCT03764631|OG001|Outcome|DPP-4 Inhibitors|Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814220|NCT03764631|EG000|Reported Event|Empagliflozin|Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814221|NCT03764631|EG001|Reported Event|DPP-4 Inhibitors|Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.
10814222|NCT03764072|BG000|Baseline|Placebo|Participants received placebo matched to VX-150 for 2 days.
10814223|NCT03764072|BG001|Baseline|VX-150 - Dose Level 1|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
10814224|NCT03764072|BG002|Baseline|VX-150 - Dose Level 2|Participants received VX-150 1000 mg qd for 2 days.
10814225|NCT03764072|BG003|Baseline|VX-150 - Dose Level 3|Participants received VX-150 500 mg q12h for 2 days.
10814226|NCT03764072|BG004|Baseline|VX-150 - Dose Level 4|Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
10814227|NCT03764072|BG005|Baseline|VX-150 - Dose Level 5|Participants received VX-150 250 mg qd for 2 days.
10814228|NCT03764072|BG006|Baseline|Total|Total of all reporting groups
10814229|NCT03764072|FG000|Participant Flow|Placebo|Participants received placebo matched to VX-150 for 2 days.
10814230|NCT03764072|FG001|Participant Flow|VX-150 - Dose Level 1|Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
10814231|NCT03764072|FG002|Participant Flow|VX-150 - Dose Level 2|Participants received VX-150 1000 mg once daily (qd) for 2 days.
10814232|NCT03764072|FG003|Participant Flow|VX-150 - Dose Level 3|Participants received VX-150 500 mg q12h for 2 days.
10814233|NCT03764072|FG004|Participant Flow|VX-150 - Dose Level 4|Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
10814234|NCT03764072|FG005|Participant Flow|VX-150 - Dose Level 5|Participants received VX-150 250 mg qd for 2 days.
10814235|NCT03764072|OG000|Outcome|Placebo|Participants received placebo matched to VX-150 for 2 days.
10814236|NCT03764072|OG001|Outcome|VX-150 - Dose Level 1|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
10814237|NCT03764072|OG002|Outcome|VX-150 - Dose Level 2|Participants received VX-150 1000 mg qd for 2 days.
10814238|NCT03764072|OG003|Outcome|VX-150 - Dose Level 3|Participants received VX-150 500 mg q12h for 2 days.
10814239|NCT03764072|OG004|Outcome|VX-150 - Dose Level 4|Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
10814240|NCT03764072|OG005|Outcome|VX-150 - Dose Level 5|Participants received VX-150 250 mg qd for 2 days.
10814241|NCT03764072|OG000|Outcome|VX-150 - Dose Level 1|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
10814242|NCT03764072|OG001|Outcome|VX-150 - Dose Level 2|Participants received VX-150 1000 mg qd for 2 days.
10814243|NCT03764072|OG002|Outcome|VX-150 - Dose Level 3|Participants received VX-150 500 mg q12h for 2 days.
10814244|NCT03764072|OG003|Outcome|VX-150 - Dose Level 4|Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
10814245|NCT03764072|OG004|Outcome|VX-150 - Dose Level 5|Participants received VX-150 250 mg qd for 2 days.
10814246|NCT03764072|EG000|Reported Event|Placebo|Participants received placebo matched to VX-150 for 2 days.
10814247|NCT03764072|EG001|Reported Event|VX-150 - Dose Level 1|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
10814248|NCT03764072|EG002|Reported Event|VX-150 - Dose Level 2|Participants received VX-150 1000 mg qd for 2 days.
10814249|NCT03764072|EG003|Reported Event|VX-150 - Dose Level 3|Participants received VX-150 500 mg q12h for 2 days.
10814250|NCT03764072|EG004|Reported Event|VX-150 - Dose Level 4|Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
10814251|NCT03764072|EG005|Reported Event|VX-150 - Dose Level 5|Participants received VX-150 250 mg qd for 2 days.
10821974|NCT00073333|EG000|Reported Event|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
10821975|NCT00073333|EG001|Reported Event|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
10821976|NCT00073333|EG002|Reported Event|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
10814252|NCT03645408|BG000|Baseline|Exenatide Then Placebo|"This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a 5 mcg dose of immediate release exenatide on the day of the first alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Subjects in this arm then received a sham injection on the day of the second alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.~Exenatide: Subject received an injection of 5 mcg of immediate release exenatide.~Sham injection: Subjects received a sham injection with no study drug."
10814253|NCT03645408|BG001|Baseline|Placebo Then Exenatide|"This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a sham injection on the day of the first alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Subjects in this arm then received a 5 mcg dose of immediate release exenatide on the day of the second alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.~Exenatide: Subject received an injection of 5 mcg of immediate release exenatide.~Sham injection: Subjects received a sham injection with no study drug."
10814254|NCT03645408|BG002|Baseline|Total|Total of all reporting groups
10814255|NCT03645408|FG000|Participant Flow|Exenatide Then Placebo|"This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a 5 mcg dose of immediate release exenatide on the day of the first alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Subjects in this arm then received a sham injection on the day of the second alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.~Sham injection: Subjects will have a sham injection with no study drug"
10814256|NCT03645408|FG001|Participant Flow|Placebo Then Exenatide|This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a sham injection on the day of the first alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Subjects in this arm then received a 5 mcg dose of immediate release exenatide on the day of the second alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.
10814257|NCT03645408|OG000|Outcome|Exenatide Injection|"Subjects received a 5 mcg dose of immediate-release exenatide on the day of the alcohol self-administration trial.~This is a within subjects design study in which each subject received both study drug and sham injection (placebo). Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind."
10814258|NCT03645408|OG001|Outcome|Sham Injection (Placebo)|"Subjects received a sham injection on the day of the alcohol self-administration trial.~This is a within subjects design study in which each subject received both study drug and sham injection (placebo). Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind."
10814259|NCT03645408|EG000|Reported Event|Exenatide|"Subjects received a 5 mcg dose of immediate-release exenatide on the day of the alcohol self-administration trial.~This is a within subjects design study in which each subject received both study drug and sham injection (placebo). Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind."
10814260|NCT03645408|EG001|Reported Event|Sham Injection (Placebo)|"Subjects received a sham injection on the day of the alcohol self-administration trial.~This is a within subjects design study in which each subject received both study drug and sham injection (placebo). Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind."
10814261|NCT03578809|BG000|Baseline|Cohort A: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push.
10814262|NCT03578809|BG001|Baseline|Cohort A: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
10814263|NCT03578809|BG002|Baseline|Cohort B: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
11206222|NCT02233985|EG001|Reported Event|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
11206223|NCT02233998|BG000|Baseline|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
11206224|NCT02233998|BG001|Baseline|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
11206225|NCT02233998|BG002|Baseline|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
11206226|NCT02233998|BG003|Baseline|Total|Total of all reporting groups
11206227|NCT02233998|FG000|Participant Flow|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
11206228|NCT02233998|FG001|Participant Flow|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
11206229|NCT02233998|FG002|Participant Flow|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
10814264|NCT03578809|BG003|Baseline|Cohort B: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
10814265|NCT03578809|BG004|Baseline|Total|Total of all reporting groups
10814266|NCT03578809|FG000|Participant Flow|Cohort A: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push.
10814267|NCT03578809|FG001|Participant Flow|Cohort A: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
10814268|NCT03578809|FG002|Participant Flow|Cohort B: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
10814269|NCT03578809|FG003|Participant Flow|Cohort B: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
10814270|NCT03578809|OG000|Outcome|Cohort A: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push.
10814271|NCT03578809|OG001|Outcome|Cohort A: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
10814272|NCT03578809|OG002|Outcome|Cohort B: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
10814273|NCT03578809|OG003|Outcome|Cohort B: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
10814274|NCT03578809|OG000|Outcome|Cohort B: Placebo|Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
10814275|NCT03578809|OG001|Outcome|Cohort B: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
10814276|NCT03578809|OG000|Outcome|Cohort A: MEDI6012|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
10814277|NCT03578809|EG000|Reported Event|Placebo Cohort A|Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push.
10814278|NCT03578809|EG001|Reported Event|MEDI6012 Cohort A|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
10814279|NCT03578809|EG002|Reported Event|Placebo Cohort B|Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
10814280|NCT03578809|EG003|Reported Event|MEDI6012 Cohort B|Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
10814281|NCT03571204|BG000|Baseline|Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
11206230|NCT02233998|OG000|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
11206231|NCT02233998|OG001|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
11206232|NCT02233998|OG002|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
11206233|NCT02233998|EG000|Reported Event|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
11206234|NCT02233998|EG001|Reported Event|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
11206235|NCT02233998|EG002|Reported Event|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
11206236|NCT02234063|BG000|Baseline|Control- Delayed Testing|Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
11206237|NCT02234063|BG001|Baseline|Immediate Genetic Testing|Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.
11206238|NCT02234063|BG002|Baseline|Total|Total of all reporting groups
11206239|NCT02234063|FG000|Participant Flow|Immediate Genetic Testing|Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.
11206240|NCT02234063|FG001|Participant Flow|Control- Delayed Testing|Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
10814282|NCT03571204|BG001|Baseline|Group 1: ART Prior to Placebo Treatment in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814283|NCT03571204|BG002|Baseline|Group 2: 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814284|NCT03571204|BG003|Baseline|Total|Total of all reporting groups
10814285|NCT03571204|FG000|Participant Flow|Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814286|NCT03571204|FG001|Participant Flow|Group 1: ART Prior to Placebo Treatment in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814287|NCT03571204|FG002|Participant Flow|Group 2: 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814288|NCT03571204|OG000|Outcome|Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814289|NCT03571204|OG001|Outcome|Group 1: ART Prior to Placebo Treatment in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814290|NCT03571204|OG002|Outcome|Group 2: 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814291|NCT03571204|OG000|Outcome|Group 2: 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814292|NCT03571204|EG000|Reported Event|Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814293|NCT03571204|EG001|Reported Event|Group 1: ART Prior to Placebo Treatment in HIV-1 Subject|Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814294|NCT03571204|EG002|Reported Event|Group 2: 3BNC117 + 10-1074 in HIV-1 Subject|Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
10814295|NCT03523091|BG000|Baseline|3 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814296|NCT03523091|BG001|Baseline|10 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814297|NCT03523091|BG002|Baseline|Total|Total of all reporting groups
10814298|NCT03523091|FG000|Participant Flow|3 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814299|NCT03523091|FG001|Participant Flow|10 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814300|NCT03523091|OG000|Outcome|3 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814301|NCT03523091|OG001|Outcome|10 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814302|NCT03523091|EG000|Reported Event|3 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814303|NCT03523091|EG001|Reported Event|10 Injection Sites|"OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder~OnabotulinumtoxinA 100Unit Injection: Initial treatment with the option of repeat injections every 3 months"
10814304|NCT03503474|BG000|Baseline|CDI Cases|No intervention: There is no intervention, this is observational only
10814305|NCT03503474|BG001|Baseline|CDI Negative Controls|No intervention: There is no intervention, this is observational only
10814306|NCT03503474|BG002|Baseline|Total|Total of all reporting groups
10814307|NCT03503474|FG000|Participant Flow|CDI Cases|No intervention: There is no intervention, this is observational only
10814308|NCT03503474|FG001|Participant Flow|CDI Negative Controls|No intervention: There is no intervention, this is observational only
10814309|NCT03503474|OG000|Outcome|CDI Cases|No intervention: There is no intervention, this is observational only
10814310|NCT03503474|OG001|Outcome|CDI Negative Controls|No intervention: There is no intervention, this is observational only
10814311|NCT03503474|EG000|Reported Event|CDI Cases|No intervention: There is no intervention, this is observational only
10814312|NCT03503474|EG001|Reported Event|CDI Negative Controls|No intervention: There is no intervention, this is observational only
10814313|NCT03476317|BG000|Baseline|Group 1-Fluconazole|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14).~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2~Fluconazole: Orally once daily (Day 1-14)"
10814314|NCT03476317|BG001|Baseline|Group 1-Placebo|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo.~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2"
10814315|NCT03476317|BG002|Baseline|Group 2|Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
10814316|NCT03476317|BG003|Baseline|Total|Total of all reporting groups
10814317|NCT03476317|FG000|Participant Flow|Group 1-Fluconazole|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14).~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2~Fluconazole: Orally once daily (Day 1-14)"
10814318|NCT03476317|FG001|Participant Flow|Group 1-Placebo|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo.~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2"
10814319|NCT03476317|FG002|Participant Flow|Group 2|Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
10814320|NCT03476317|OG000|Outcome|Group 1-Fluconazole|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14).~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2~Fluconazole: Orally once daily (Day 1-14)"
10814321|NCT03476317|OG001|Outcome|Group 1-Placebo|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo.~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2"
10814322|NCT03476317|OG002|Outcome|Group 2|Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
10814323|NCT03476317|EG000|Reported Event|Group 1-Fluconazole|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14).~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2~Fluconazole: Orally once daily (Day 1-14)"
10814324|NCT03476317|EG001|Reported Event|Group 1-Placebo|"Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo.~Vancomycin: Oral suspension 4 times daily (Day 1-14)~Neomycin: Oral three times daily (Days 1-3)~Ciprofloxacin: Oral twice daily (Days 4-14)~Polyethylene Glycol 3350: Dissolved in Gatorade on day 2"
10814325|NCT03476317|EG002|Reported Event|Group 2|Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
10814326|NCT03391960|BG000|Baseline|Not Applicable|During the study, Baseline data were not collected for the health care workers. No individual patient was consented in the study.
10814327|NCT03391960|FG000|Participant Flow|Compliance With Scrub the Hub Protocol|Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector
10814328|NCT03391960|FG001|Participant Flow|Compliance With Disinfecting Barrier Cap Ptotocol|"In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines.~Compliance with disinfecting barrier cap was observed weekly."
10814329|NCT03391960|OG000|Outcome|Disinfecting Barrier Cap Compliance|"In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines.~Compliance with disinfecting barrier cap was observed weekly."
10814330|NCT03391960|OG000|Outcome|Scrub the Hub Protocol Compliance|"Compliance with Scrub the hub protocol~Data collected by survey~No individual patient's information was collected during the study"
10814331|NCT03391960|OG000|Outcome|CLABSI Rate for Pre-intervention Period|Number of CLABSI infections and CVC/day recorded during 6 pre-intervention months were used to determine the rate of CLABSI during the 6-month pre-intervention period.
10814332|NCT03391960|OG001|Outcome|CLABSI Rate for Post-intervention Period|Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
10814333|NCT03391960|OG000|Outcome|CAUTI Rate 6 Months Pre-intervention|CAUTI rate per 1000 catheter/days during 6 months pre-intervention
10814334|NCT03391960|OG001|Outcome|CAUTI Rate 6 Months Post-intervention|CAUTI rate per 1000 catheter/days during 6 months post intervention
10814335|NCT03391960|OG000|Outcome|VAP Rate Pre-intervention|VAP rate per 1000 ventilator days 6 months pre-intervention
10814336|NCT03391960|OG001|Outcome|VAP Rate Post Intervention|VAP rate per 1000 ventilator days 6 months post-intervention
10814337|NCT03391960|OG000|Outcome|MBI-related CLABSI Rate for Pre-intervention Period|Number of MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of MBI CLABSI during the pre-intervention period.
10814338|NCT03391960|OG001|Outcome|MBI-related CLABSI Rate for Prospective Period|Number of MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of MBI CLABSI during the prospective period.
10814339|NCT03391960|OG000|Outcome|Non-MBI CLABSI Rate for Pre-intervention Period|Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of CLABSI during the pre-intervention period
10814340|NCT03391960|OG001|Outcome|Non-MBI CLABSI Rate for Prospective Period|Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of CLABSI during the prospective period.
10814341|NCT03391960|EG000|Reported Event||No individual patient data (including adverse events [AEs]) were recorded during this study.
10814342|NCT03362190|BG000|Baseline|Cohort 1|Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
10814343|NCT03362190|BG001|Baseline|Cohort 2|Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)
10814344|NCT03362190|BG002|Baseline|Cohort 3|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)"
10814345|NCT03362190|BG003|Baseline|Cohort 4|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)"
10814346|NCT03362190|BG004|Baseline|Total|Total of all reporting groups
10814347|NCT03362190|FG000|Participant Flow|Cohort 1|Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
10814348|NCT03362190|FG001|Participant Flow|Cohort 2|Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)
10814349|NCT03362190|FG002|Participant Flow|Cohort 3|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)"
10814350|NCT03362190|FG003|Participant Flow|Cohort 4|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis)"
10814351|NCT03362190|OG000|Outcome|Cohort 1|Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg
10814352|NCT03362190|OG001|Outcome|Cohort 2|Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)
10814353|NCT03362190|OG002|Outcome|Cohort 3|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)"
10814354|NCT03362190|OG003|Outcome|Cohort 4|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura & 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura & 3 doses of Lucentis)"
10821977|NCT00073528|BG000|Baseline|Placebo + Letrozole 2.5 mg|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.
10814355|NCT03362190|OG003|Outcome|Cohort 4|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses of Zimura & 3 doses Lucentis)"
10814356|NCT03362190|OG001|Outcome|Cohort 2|Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)
10814357|NCT03362190|OG003|Outcome|Cohort 4|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)"
10814358|NCT03362190|EG000|Reported Event|Cohort 1|Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4 mg
10814359|NCT03362190|EG001|Reported Event|Cohort 2|Monthly administration of Zimura 2 mg + Lucentis 0.5 mg (given on the same day)
10814360|NCT03362190|EG002|Reported Event|Cohort 3|"Zimura 2mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)"
10814361|NCT03362190|EG003|Reported Event|Cohort 4|"Zimura 2 mg + Lucentis 0.5 mg~Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2 mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis)~Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2 mg + Lucentis 0.5 mg (Total: 6 doses of Zimura & 3 doses Lucentis)"
10814362|NCT03252522|BG000|Baseline|Intervention|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814363|NCT03252522|BG001|Baseline|Placebo|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
10814364|NCT03252522|BG002|Baseline|Total|Total of all reporting groups
10814365|NCT03252522|FG000|Participant Flow|Intervention|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
11206241|NCT02234063|OG000|Outcome|Control- Delayed Testing|Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
10814366|NCT03252522|FG001|Participant Flow|Placebo|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
10814367|NCT03252522|FG002|Participant Flow|Open Label|"All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814368|NCT03252522|OG000|Outcome|Intervention|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814369|NCT03252522|OG001|Outcome|Placebo|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
10814370|NCT03252522|OG000|Outcome|Intervention (Baseline)|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814371|NCT03252522|OG001|Outcome|Intervention (Week 8)|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814372|NCT03252522|OG002|Outcome|Placebo (Baseline)|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
10814373|NCT03252522|OG003|Outcome|Placebo (Week 8)|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
11206242|NCT02234063|OG001|Outcome|Immediate Genetic Testing for APOL1 Negative|Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
10814374|NCT03252522|EG000|Reported Event|Intervention|"Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814375|NCT03252522|EG001|Reported Event|Placebo|"Capsules of inactive placebo.~Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks."
10814376|NCT03252522|EG002|Reported Event|Open Label|"All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.~Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks"
10814377|NCT03235544|BG000|Baseline|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814378|NCT03235544|BG001|Baseline|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814379|NCT03235544|BG002|Baseline|Cohort 2: Treatment A (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814380|NCT03235544|BG003|Baseline|Cohort 2: Treatment B (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814381|NCT03235544|BG004|Baseline|Total|Total of all reporting groups
10814382|NCT03235544|FG000|Participant Flow|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814383|NCT03235544|FG001|Participant Flow|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814384|NCT03235544|FG002|Participant Flow|Cohort 2: Treatment A (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814385|NCT03235544|FG003|Participant Flow|Cohort 2: Treatment B (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814386|NCT03235544|OG000|Outcome|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814387|NCT03235544|OG001|Outcome|Cohort 1: Treatment B (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814388|NCT03235544|OG002|Outcome|Cohort 2: Treatment A (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814389|NCT03235544|OG003|Outcome|Cohort 2: Treatment B (BTK Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814390|NCT03235544|EG000|Reported Event|Cohort 1: Treatment A (Exposed to Ibrutinib)|Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814391|NCT03235544|EG001|Reported Event|Cohort 1: Treatment B (Exposed to Ibrutinib)E|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
10814392|NCT03235544|EG002|Reported Event|Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
10814393|NCT03235544|EG003|Reported Event|Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)|Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
10814394|NCT03235544|EG004|Reported Event|Total|Total
10814395|NCT03225833|BG000|Baseline|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10814396|NCT03225833|BG001|Baseline|WVE-120101 (2 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814397|NCT03225833|BG002|Baseline|WVE-120101 (4 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814398|NCT03225833|BG003|Baseline|WVE-120101 (8 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814399|NCT03225833|BG004|Baseline|WVE-120101 (16 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814400|NCT03225833|BG005|Baseline|WVE-120101 (32 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814401|NCT03225833|BG006|Baseline|Total|Total of all reporting groups
10814402|NCT03225833|FG000|Participant Flow|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10814403|NCT03225833|FG001|Participant Flow|WVE-120101 (2 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814404|NCT03225833|FG002|Participant Flow|WVE-120101 (4 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814405|NCT03225833|FG003|Participant Flow|WVE-120101 (8 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814406|NCT03225833|FG004|Participant Flow|WVE-120101 (16 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814407|NCT03225833|FG005|Participant Flow|WVE-120101 (32 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814408|NCT03225833|OG000|Outcome|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10814409|NCT03225833|OG001|Outcome|WVE-120101 (2 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814410|NCT03225833|OG002|Outcome|WVE-120101 (4 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814411|NCT03225833|OG003|Outcome|WVE-120101 (8 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814412|NCT03225833|OG004|Outcome|WVE-120101 (16 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814413|NCT03225833|OG005|Outcome|WVE-120101 (32 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814414|NCT03225833|OG000|Outcome|WVE-120101 (2 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814415|NCT03225833|OG001|Outcome|WVE-120101 (4 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814416|NCT03225833|OG002|Outcome|WVE-120101 (8 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814417|NCT03225833|OG003|Outcome|WVE-120101 (16 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814418|NCT03225833|OG004|Outcome|WVE-120101 (32 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814419|NCT03225833|EG000|Reported Event|Pooled Placebo|Placebo: 0.9% Sodium Chloride
10814420|NCT03225833|EG001|Reported Event|WVE-120101 (2 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814421|NCT03225833|EG002|Reported Event|WVE-120101 (4 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814422|NCT03225833|EG003|Reported Event|WVE-120101 (8 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814423|NCT03225833|EG004|Reported Event|WVE-120101 (16 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814424|NCT03225833|EG005|Reported Event|WVE-120101 (32 mg)|WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
10814425|NCT03167242|BG000|Baseline|PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg
10814426|NCT03167242|BG001|Baseline|Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814427|NCT03167242|BG002|Baseline|Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
10814428|NCT03167242|BG003|Baseline|Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814429|NCT03167242|BG004|Baseline|Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814430|NCT03167242|BG005|Baseline|Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814431|NCT03167242|BG006|Baseline|Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814432|NCT03167242|BG007|Baseline|Part A - Cohort 7: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814433|NCT03167242|BG008|Baseline|Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814434|NCT03167242|BG009|Baseline|Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814435|NCT03167242|BG010|Baseline|Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814436|NCT03167242|BG011|Baseline|Part B - Cohort 4: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814437|NCT03167242|BG012|Baseline|Total|Total of all reporting groups
10814438|NCT03167242|FG000|Participant Flow|PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg
10814439|NCT03167242|FG001|Participant Flow|Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814440|NCT03167242|FG002|Participant Flow|Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
10814441|NCT03167242|FG003|Participant Flow|Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814442|NCT03167242|FG004|Participant Flow|Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814443|NCT03167242|FG005|Participant Flow|Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814444|NCT03167242|FG006|Participant Flow|Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814445|NCT03167242|FG007|Participant Flow|Part A - Cohort 7: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814446|NCT03167242|FG008|Participant Flow|Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814447|NCT03167242|FG009|Participant Flow|Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814448|NCT03167242|FG010|Participant Flow|Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814449|NCT03167242|FG011|Participant Flow|Part B - Cohort 4: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814450|NCT03167242|OG000|Outcome|Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814451|NCT03167242|OG001|Outcome|Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
10814452|NCT03167242|OG002|Outcome|Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814453|NCT03167242|OG003|Outcome|Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814454|NCT03167242|OG004|Outcome|Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814455|NCT03167242|OG005|Outcome|Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814456|NCT03167242|OG006|Outcome|Part A - Cohort 7: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814457|NCT03167242|OG007|Outcome|Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
11244344|NCT02510001|OG000|Outcome|Dose Escalation Phase Dose 5|"Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10814458|NCT03167242|OG008|Outcome|Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814459|NCT03167242|OG009|Outcome|Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814460|NCT03167242|OG010|Outcome|Part B - Cohort 4: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814461|NCT03167242|OG000|Outcome|PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg
10814462|NCT03167242|OG001|Outcome|Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814463|NCT03167242|OG002|Outcome|Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
10814464|NCT03167242|OG003|Outcome|Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814465|NCT03167242|OG004|Outcome|Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814466|NCT03167242|OG005|Outcome|Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814467|NCT03167242|OG006|Outcome|Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814468|NCT03167242|OG007|Outcome|Part A - Cohort 7: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814469|NCT03167242|OG008|Outcome|Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814470|NCT03167242|OG009|Outcome|Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814471|NCT03167242|OG010|Outcome|Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814472|NCT03167242|OG011|Outcome|Part B - Cohort 4: Coartem|Participants received Coartem twice daily via oral administration for 3 days
10814473|NCT03167242|OG006|Outcome|Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day|Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814474|NCT03167242|OG007|Outcome|Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
10814475|NCT03167242|OG008|Outcome|Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days|Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814476|NCT03167242|EG000|Reported Event|PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day|PK Run-in participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg
10814477|NCT03167242|EG001|Reported Event|Part A: KAF 800 mg and LUM 960 mg QD for 1 Day|Part A - Cohort 2 participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
10814478|NCT03167242|EG002|Reported Event|Part A: KAF 200 mg and LUM 480 mg QD for 3 Days|Part A - Cohort 4 participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814479|NCT03167242|EG003|Reported Event|Part A: KAF 400 mg and LUM 480 mg QD for 3 Days|Part A - Cohort 5 participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
10814480|NCT03167242|EG004|Reported Event|Part A and Part B: KAF 400 mg and LUM 960 mg QD for 1 Day|Part A - Cohort 1 and Part B - Cohort 1 participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
10814481|NCT03167242|EG005|Reported Event|Part A and Part B: KAF 400 mg and LUM 960 mg QD for 2 Days|Part A - Cohort 3 and Part B - Cohort 2 participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
11244345|NCT02510001|OG001|Outcome|Dose Escalation Phase Dose 5 (Interval Dosing)|"Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
10814482|NCT03167242|EG006|Reported Event|Part A and Part B: KAF 400 mg and LUM 960 mg QD for 3 Days|Part A - Cohort 6 and Part B - Cohort 3 participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
10814483|NCT03167242|EG007|Reported Event|Part A and Part B: Coartem|Part A - Cohort 7 and Part B - Cohort 4 participants received Coartem twice daily via oral administration for 3 days
10821978|NCT00073528|BG001|Baseline|Lapatinib 1500 mg + Letrozole 2.5 mg|Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.
10821979|NCT00073528|BG002|Baseline|Total|Total of all reporting groups
10821980|NCT00073528|FG000|Participant Flow|Placebo + Letrozole 2.5 mg|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.
10821981|NCT00073528|FG001|Participant Flow|Lapatinib 1500 mg + Letrozole 2.5 mg|Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.
10821982|NCT00073528|OG000|Outcome|Placebo + Letrozole 2.5 mg|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.
10821983|NCT00073528|OG001|Outcome|Lapatinib 1500 mg + Letrozole 2.5 mg|Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.
10821984|NCT00073528|EG000|Reported Event|Placebo + Letrozole 2.5 mg|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.
10821985|NCT00073528|EG001|Reported Event|Lapatinib 1500 mg + Letrozole 2.5 mg|Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.
10821986|NCT00073749|BG000|Baseline|Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1|Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821987|NCT00073749|BG001|Baseline|Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2|Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821988|NCT00073749|BG002|Baseline|Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3|Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821989|NCT00073749|BG003|Baseline|Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821990|NCT00073749|BG004|Baseline|Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5|Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821991|NCT00073749|BG005|Baseline|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10821992|NCT00073749|BG006|Baseline|Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10821993|NCT00073749|BG007|Baseline|Total|Total of all reporting groups
10821994|NCT00073749|FG000|Participant Flow|Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1|Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821995|NCT00073749|FG001|Participant Flow|Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2|Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10821996|NCT00073749|FG002|Participant Flow|Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3|Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
11206243|NCT02234063|OG002|Outcome|Immediate Genetic Testing for APOL1 Positive|Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
10814484|NCT03137537|BG000|Baseline|Ivabradine|"Ivabradine will be administered for a total of 6 weeks~Ivabradine is taken orally twice daily~Dosage will be adjusted according to physician determination~Ivabradine: lower heart rate in heart failure patients."
10814485|NCT03137537|BG001|Baseline|Placebo Oral Tablet|"Placebo will be administered for a total of 6 weeks~Placebo is taken orally twice daily~Dosage will be adjusted according to physician determination~Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine."
10814486|NCT03137537|BG002|Baseline|Total|Total of all reporting groups
10814487|NCT03137537|FG000|Participant Flow|Ivabradine|"Ivabradine will be administered for a total of 6 weeks~Ivabradine is taken orally twice daily~Dosage will be adjusted according to physician determination~Ivabradine: lower heart rate in heart failure patients."
10814488|NCT03137537|FG001|Participant Flow|Placebo Oral Tablet|"Placebo will be administered for a total of 6 weeks~Placebo is taken orally twice daily~Dosage will be adjusted according to physician determination~Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine."
10814489|NCT03137537|OG000|Outcome|Ivabradine|"Ivabradine will be administered for a total of 6 weeks~Ivabradine is taken orally twice daily~Dosage will be adjusted according to physician determination~Ivabradine: lower heart rate in heart failure patients."
10814490|NCT03137537|OG001|Outcome|Placebo Oral Tablet|"Placebo will be administered for a total of 6 weeks~Placebo is taken orally twice daily~Dosage will be adjusted according to physician determination~Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine."
10814491|NCT03137537|EG000|Reported Event|Ivabradine|"Ivabradine will be administered for a total of 6 weeks~Ivabradine is taken orally twice daily~Dosage will be adjusted according to physician determination~Ivabradine: lower heart rate in heart failure patients."
10814492|NCT03137537|EG001|Reported Event|Placebo Oral Tablet|"Placebo will be administered for a total of 6 weeks~Placebo is taken orally twice daily~Dosage will be adjusted according to physician determination~Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine."
10814493|NCT03126019|BG000|Baseline|Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW|Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.
10814494|NCT03126019|BG001|Baseline|Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD|Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
10814495|NCT03126019|BG002|Baseline|Total|Total of all reporting groups
10814496|NCT03126019|FG000|Participant Flow|Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW|Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
10814497|NCT03126019|FG001|Participant Flow|Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD|Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
10814498|NCT03126019|OG000|Outcome|Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW|Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.
10814499|NCT03126019|OG001|Outcome|Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD|Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
10814500|NCT03126019|EG000|Reported Event|Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW|Participants received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW for up to approximately 52 weeks.
10814501|NCT03126019|EG001|Reported Event|Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD|Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
10814502|NCT03126019|EG002|Reported Event|Total|Total
10814503|NCT03113383|BG000|Baseline|Experimental: Primary Arm|Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
10814504|NCT03113383|FG000|Participant Flow|Experimental: Primary Arm|Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
10814505|NCT03113383|FG001|Participant Flow|Experimental: Expanded Selection Arm|Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
10814506|NCT03113383|OG000|Outcome|Primary Arm|"Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.~Thoracoabdominal Aortic Aneurysm Repair: Thoracoabdominal aortic aneurysm repair"
10814507|NCT03113383|OG001|Outcome|Expanded Selection Arm|"Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.~Thoracoabdominal Aortic Aneurysm Repair: Thoracoabdominal aortic aneurysm repair"
10814508|NCT03113383|EG000|Reported Event|Experimental: Primary Arm|Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
10814509|NCT03113383|EG001|Reported Event|Experimental: Expanded Selection Arm|Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
10814519|NCT03028896|BG000|Baseline|Standard|In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
10814520|NCT03028896|BG001|Baseline|Rotational|"After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.~90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°"
10814521|NCT03028896|BG002|Baseline|Total|Total of all reporting groups
10814522|NCT03028896|FG000|Participant Flow|Standard|In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
10814523|NCT03028896|FG001|Participant Flow|Rotational|"After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.~90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°"
10814524|NCT03028896|OG000|Outcome|Standard|In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
10814525|NCT03028896|OG001|Outcome|Rotational|"After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.~90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°"
10814526|NCT03028896|EG000|Reported Event|Standard|In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
10814527|NCT03028896|EG001|Reported Event|Rotational|"After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.~90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°"
10814528|NCT03008369|BG000|Baseline|Treatment (Lenvatinib)|Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenvatinib: Given PO Quality-of-Life Assessment: Ancillary studies
10814529|NCT03008369|FG000|Participant Flow|Treatment (Lenvatinib)|Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
10814530|NCT03008369|OG000|Outcome|Treatment (Lenvatinib)|Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
10814531|NCT03008369|EG000|Reported Event|Treatment (Lenvatinib)|Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenvatinib: Given PO Quality-of-Life Assessment: Ancillary studies
10814532|NCT02978326|BG000|Baseline|Part A: SAGE-217 15/20 mg Oral Solution|Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
10814533|NCT02978326|BG001|Baseline|Part B: Placebo|Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
10814534|NCT02978326|BG002|Baseline|Part B: SAGE 217 30 mg Capsules|Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
10814535|NCT02978326|BG003|Baseline|Total|Total of all reporting groups
10814536|NCT02978326|FG000|Participant Flow|Part A: SAGE-217 15/20 mg Oral Solution|Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
10814537|NCT02978326|FG001|Participant Flow|Part B: Placebo|Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
10814538|NCT02978326|FG002|Participant Flow|Part B: SAGE 217 30 mg Capsules|Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
10814539|NCT02978326|OG000|Outcome|Part A: SAGE-217 15/20 mg Oral Solution|Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
10814540|NCT02978326|OG001|Outcome|Part B: Placebo|Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
10814541|NCT02978326|OG002|Outcome|Part B: SAGE 217 30 mg Capsules|Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
10814542|NCT02978326|OG000|Outcome|Part B: Placebo|Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
10814543|NCT02978326|OG001|Outcome|Part B: SAGE 217 30 mg Capsules|Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
10814544|NCT02978326|EG000|Reported Event|Part A: SAGE-217 15/20 mg Oral Solution|Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
10814545|NCT02978326|EG001|Reported Event|Part B: Placebo|Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
10814546|NCT02978326|EG002|Reported Event|Part B: SAGE 217 30 mg Capsules|Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
10814547|NCT02970929|BG000|Baseline|SEP-363856|SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
10814548|NCT02970929|FG000|Participant Flow|SEP-363856|SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
10814549|NCT02970929|OG000|Outcome|SEP-363856|SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
10814550|NCT02970929|OG000|Outcome|PBO-SEP|Subjects who received Placebo in study SEP361-201 and SEP-363856 in study SEP361-202
10814551|NCT02970929|OG001|Outcome|SEP-SEP|Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
10814552|NCT02970929|EG000|Reported Event|SEP-363856|SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
10814553|NCT02963493|BG000|Baseline|Melphalan Flufenamide (Melflufen) + Dexamethasone|"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone"
10814554|NCT02963493|FG000|Participant Flow|Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set|"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone"
10814555|NCT02963493|OG000|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set|"Full analysis set~Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe."
10814556|NCT02963493|OG001|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease|Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass
10814557|NCT02963493|OG002|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease|Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
10814558|NCT02963493|OG000|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set|"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe."
10814559|NCT02963493|OG001|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease|Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
10814560|NCT02963493|OG000|Outcome|Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set|"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone"
10814561|NCT02963493|EG000|Reported Event|Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set|"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.~Melphalan flufenamide (Melflufen)~Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe."
10814562|NCT02963493|EG001|Reported Event|Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease|Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass.
10814563|NCT02963493|EG002|Reported Event|Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease|Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody.
10814564|NCT02899078|BG000|Baseline|Treatment (Ibrutinib, Nivolumab)|"Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO Nivolumab: Given IV"
10814565|NCT02899078|FG000|Participant Flow|Treatment (Ibrutinib, Nivolumab)|"Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO Nivolumab: Given IV"
10814566|NCT02899078|OG000|Outcome|Treatment (Ibrutinib, Nivolumab)|"Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO Nivolumab: Given IV"
10814567|NCT02899078|EG000|Reported Event|Treatment (Ibrutinib, Nivolumab)|"Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Given PO Nivolumab: Given IV"
10814568|NCT02873975|BG000|Baseline|Homologous Repair (HR) Deficiency Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with homologous repair (HR) deficiency on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814569|NCT02873975|BG001|Baseline|Replicative Stress Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with advanced solid tumors exhibiting replicative stress on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814570|NCT02873975|BG002|Baseline|CCNE1 Amplification Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with CCNE1 amplification on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814571|NCT02873975|BG003|Baseline|Total|Total of all reporting groups
10814572|NCT02873975|FG000|Participant Flow|Homologous Repair (HR) Deficiency Cohort|"Prexasertib (LY2606368) will be administered as an IV infusion in patients with homologous repair (HR) deficiency on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.~LY2606368"
10814573|NCT02873975|FG001|Participant Flow|Replicative Stress Cohort|"Prexasertib (LY2606368) will be administered as an IV infusion in patients with advanced solid tumors exhibiting replicative stress on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.~LY2606368"
10814574|NCT02873975|FG002|Participant Flow|CCNE1 Amplification Cohort|"Prexasertib (LY2606368) will be administered as an IV infusion in patients with CCNE1 amplification on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.~LY2606368"
10814575|NCT02873975|OG000|Outcome|Homologous Repair (HR) Deficiency Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with homologous repair (HR) deficiency on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814576|NCT02873975|OG001|Outcome|Replicative Stress Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with advanced solid tumors exhibiting replicative stress on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814577|NCT02873975|OG002|Outcome|CCNE1 Amplification Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with CCNE1 amplification on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814578|NCT02873975|EG000|Reported Event|Homologous Repair (HR) Deficiency Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with homologous repair (HR) deficiency on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814579|NCT02873975|EG001|Reported Event|Replicative Stress Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with advanced solid tumors exhibiting replicative stress on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814580|NCT02873975|EG002|Reported Event|CCNE1 Amplification Cohort|Prexasertib (LY2606368) will be administered as an IV infusion in patients with CCNE1 amplification on day 1 and day 15 of every 28 day cycle. Prexasertib will be given at the recommended phase 2 dose of 105 mg/m2 administered over approximately 1 hour.
10814581|NCT02797951|BG000|Baseline|Galcanezumab 300 mg SC|Participants received 300 mg Galcanezumab administered SC up to once a month.
10814582|NCT02797951|FG000|Participant Flow|Galcanezumab 300 mg SC|Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
10814583|NCT02797951|OG000|Outcome|Galcanezumab 300 mg SC|Participants received 300 mg Galcanezumab administered SC up to once a month.
10814584|NCT02797951|EG000|Reported Event|Galcanezumab 300 mg SC|Participants received 300 mg Galcanezumab administered SC up to once a month.
10814585|NCT02753751|BG000|Baseline|Usual Care|No alert will be fired.
10814586|NCT02753751|BG001|Baseline|Electronic AKI Alert|"A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.~AKI Alert: Provider's will receive a pop-up alert in the electronic health record until AKI is documented in the problem list or AKI resolves."
10814587|NCT02753751|BG002|Baseline|Total|Total of all reporting groups
10814588|NCT02753751|FG000|Participant Flow|Usual Care|No alert will be fired.
10814589|NCT02753751|FG001|Participant Flow|Electronic AKI Alert|"A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.~AKI Alert: Provider's will receive a pop-up alert in the electronic health record until AKI is documented in the problem list or AKI resolves."
10814590|NCT02753751|OG000|Outcome|Usual Care|No alert will be fired.
10814591|NCT02753751|OG001|Outcome|Electronic AKI Alert|"A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.~AKI Alert: Provider's will receive a pop-up alert in the electronic health record until AKI is documented in the problem list or AKI resolves."
10814592|NCT02753751|EG000|Reported Event|Usual Care|No alert will be fired.
10814593|NCT02753751|EG001|Reported Event|Electronic AKI Alert|"A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.~AKI Alert: Provider's will receive a pop-up alert in the electronic health record until AKI is documented in the problem list or AKI resolves."
10814594|NCT02748057|BG000|Baseline|Ezetimibe 10 mg + Rosuvastatin 2.5 mg|1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
10814595|NCT02748057|BG001|Baseline|Ezetimibe 10 mg + Rosuvastatin 5.0 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
10814596|NCT02748057|BG002|Baseline|Total|Total of all reporting groups
10814597|NCT02748057|FG000|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 2.5 mg|1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
10814598|NCT02748057|FG001|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 5.0 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
10814599|NCT02748057|OG000|Outcome|Ezetimibe 10 mg + Rosuvastatin 2.5 mg|1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
10814600|NCT02748057|OG001|Outcome|Ezetimibe 10 mg + Rosuvastatin 5.0 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
11206244|NCT02234063|OG000|Outcome|Immediate Genetic Testing for APOL1 Negative|Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
11206245|NCT02234063|OG001|Outcome|Immediate Genetic Testing for APOL1 Positive|Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
11206246|NCT02234063|OG002|Outcome|Control- Delayed Testing|Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
11206247|NCT02234063|EG000|Reported Event|Control- Delayed Testing|Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
11206248|NCT02234063|EG001|Reported Event|Immediate Genetic Testing for APOL1 Negative|Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
11206249|NCT02234063|EG002|Reported Event|Immediate Genetic Testing for APOL1 Positive|Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
11206250|NCT02234115|BG000|Baseline|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
11206251|NCT02234115|FG000|Participant Flow|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
11206252|NCT02234115|OG000|Outcome|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
11206253|NCT02234115|EG000|Reported Event|Leuprolide Mesylate 50mg|"All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.~Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate"
11206254|NCT02234128|BG000|Baseline|EVLP Double Lung Group|"Toronto EVLP System™ administered to double lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
10814601|NCT02748057|EG000|Reported Event|Ezetimibe 10 mg + Rosuvastatin 2.5 mg|1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
10814602|NCT02748057|EG001|Reported Event|Ezetimibe 10 mg + Rosuvastatin 5.0 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
10814603|NCT02741271|BG000|Baseline|MF/F MDI 100/10 mcg BID|MF/F administered by MDI, given as 100/10 mcg BID
10814604|NCT02741271|BG001|Baseline|MF MDI 100 mcg BID|MF administered by MDI, given as 100 mcg BID
10814605|NCT02741271|BG002|Baseline|Total|Total of all reporting groups
10814606|NCT02741271|FG000|Participant Flow|MF/F MDI 100/10 mcg BID|MF/F administered by MDI, given as 100/10 mcg BID
10814607|NCT02741271|FG001|Participant Flow|MF MDI 100 mcg BID|MF administered by MDI, given as 100 mcg BID
10814608|NCT02741271|OG000|Outcome|MF/F MDI 100/10 mcg BID|MF/F administered by MDI, given as 100/10 mcg BID
10814609|NCT02741271|OG001|Outcome|MF MDI 100 mcg BID|MF administered by MDI, given as 100 mcg BID
10814610|NCT02741271|OG002|Outcome|Total|All treated participants
10814611|NCT02741271|OG000|Outcome|Pooled MF/F 100/10 mcg and MF 100 mcg|MF/F 100/10 mcg BID or MF 100 mcg BID, administered by MDI
10814612|NCT02741271|EG000|Reported Event|MF/F MDI 100/10 mcg BID|MF/F administered by MDI, given as 100/10 mcg BID
10814613|NCT02741271|EG001|Reported Event|MF MDI 100 mcg BID|MF administered by MDI, given as 100 mcg BID
10814614|NCT02741245|BG000|Baseline|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
10814615|NCT02741245|BG001|Baseline|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
10814616|NCT02741245|BG002|Baseline|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
10814617|NCT02741245|BG003|Baseline|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
10814618|NCT02741245|BG004|Baseline|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
10814619|NCT02741245|BG005|Baseline|Total|Total of all reporting groups
10814620|NCT02741245|FG000|Participant Flow|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
10814621|NCT02741245|FG001|Participant Flow|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
10814622|NCT02741245|FG002|Participant Flow|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
10814623|NCT02741245|FG003|Participant Flow|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
10814624|NCT02741245|FG004|Participant Flow|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
10814625|NCT02741245|OG000|Outcome|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
10814626|NCT02741245|OG001|Outcome|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
10814627|NCT02741245|OG002|Outcome|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
10814628|NCT02741245|OG003|Outcome|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
10814629|NCT02741245|OG004|Outcome|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
10814630|NCT02741245|EG000|Reported Event|Ezetimibe 10 mg|1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
10814631|NCT02741245|EG001|Reported Event|Rosuvastatin 2.5 mg|1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
10814632|NCT02741245|EG002|Reported Event|Rosuvastatin 5.0 mg|2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
10814633|NCT02741245|EG003|Reported Event|Ezetimibe 10 mg+ Rosuvastatin 2.5 mg|1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
10814634|NCT02741245|EG004|Reported Event|Ezetimibe 10 mg+ Rosuvastatin 5.0 mg|1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
10814635|NCT02688608|BG000|Baseline|Pembrolizumab|"200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.~Pembrolizumab: 200 mg IV once every 3 weeks"
10814636|NCT02688608|FG000|Participant Flow|Pembrolizumab|"200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.~Pembrolizumab: 200 mg IV once every 3 weeks"
10814637|NCT02688608|OG000|Outcome|Pembrolizumab|"200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.~Pembrolizumab: 200 mg IV once every 3 weeks"
10814638|NCT02688608|EG000|Reported Event|Pembrolizumab|"200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.~Pembrolizumab: 200 mg IV once every 3 weeks"
10814639|NCT02675231|BG000|Baseline|150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant|150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
10814640|NCT02675231|BG001|Baseline|150 mg Abemaciclib + 8 mg/kg Trastuzumab|150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
10814641|NCT02675231|BG002|Baseline|8 mg/kg Trastuzumab + Standard of Care Chemotherapy|8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
10814642|NCT02675231|BG003|Baseline|Total|Total of all reporting groups
11206255|NCT02234128|BG001|Baseline|EVLP Single Lung Group|"Toronto EVLP System™ administered to single lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206256|NCT02234128|BG002|Baseline|Control Group|Those patients receiving a single or double lung via conventional transplant.
11206257|NCT02234128|BG003|Baseline|Total|Total of all reporting groups
11206258|NCT02234128|FG000|Participant Flow|EVLP Double Lung Group|"Toronto EVLP System™ administered to double lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206259|NCT02234128|FG001|Participant Flow|EVLP Single Lung Group|"Toronto EVLP System™ administered to single lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206260|NCT02234128|FG002|Participant Flow|Control Group|Those patients receiving a single or double lung via conventional transplant.
11206261|NCT02234128|OG000|Outcome|EVLP Double Lung Group|"Toronto EVLP System™ administered to double lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206262|NCT02234128|OG001|Outcome|EVLP Single Lung Group|"Toronto EVLP System™ administered to single lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206263|NCT02234128|OG002|Outcome|Control Group|Those patients receiving a single or double lung via conventional transplant.
11206264|NCT02234128|EG000|Reported Event|EVLP Double Lung Group|"Toronto EVLP System™ administered to double lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206265|NCT02234128|EG001|Reported Event|EVLP Single Lung Group|"Toronto EVLP System™ administered to single lungs.~Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System"
11206266|NCT02234128|EG002|Reported Event|Control Group|Those patients receiving a single or double lung via conventional transplant.
11206267|NCT02234141|BG000|Baseline|Selonsertib 2 mg|Participants received selonsertib 2 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11206268|NCT02234141|BG001|Baseline|Selonsertib 6 mg|Participants received selonsertib 6 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11206269|NCT02234141|BG002|Baseline|Selonsertib 18 mg|Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11206270|NCT02234141|BG003|Baseline|Placebo|Participants received placebo tablet once daily for 24 weeks (Period 1).
11206271|NCT02234141|BG004|Baseline|Total|Total of all reporting groups
11206272|NCT02234141|FG000|Participant Flow|Selonsertib 2 mg|Participants were randomized to receive selonsertib 2 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2).
11206273|NCT02234141|FG001|Participant Flow|Selonsertib 6 mg|Participants were randomized to receive selonsertib 6 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2).
11206274|NCT02234141|FG002|Participant Flow|Selonsertib 18 mg|Participants were randomized to receive selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2).
11206275|NCT02234141|FG003|Participant Flow|Placebo|Participants were randomized received placebo tablet once daily for 24 weeks (Period 1) and may have been rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase (Period 2).
11206276|NCT02234141|FG004|Participant Flow|Placebo to Selonsertib 2 mg|Participants received placebo in Period 1 and were rerandomized to receive selonsertib 2 mg tablet once daily during the long-term treatment phase (Period 2).
11206277|NCT02234141|FG005|Participant Flow|Placebo to Selonsertib 6 mg|Participants received placebo in Period 1 and were rerandomized to receive selonsertib 6 mg tablet once daily during the long-term treatment phase (Period 2).
11206278|NCT02234141|FG006|Participant Flow|Placebo to Selonsertib 18 mg|Participants received placebo in Period 1 and were rerandomized to receive selonsertib 18 mg tablet once daily during the long-term treatment phase (Period 2).
11206279|NCT02234141|OG000|Outcome|Selonsertib 2 mg|Participants received selonsertib 2 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11206280|NCT02234141|OG001|Outcome|Selonsertib 6 mg|Participants received selonsertib 6 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
10814643|NCT02675231|FG000|Participant Flow|150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant|150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
10814644|NCT02675231|FG001|Participant Flow|150 mg Abemaciclib + 8 mg/kg Trastuzumab|150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
10814645|NCT02675231|FG002|Participant Flow|8 mg/kg Trastuzumab + Standard of Care Chemotherapy|8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
10814646|NCT02675231|OG000|Outcome|150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant|150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
10814647|NCT02675231|OG001|Outcome|150 mg Abemaciclib + 8 mg/kg Trastuzumab|150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
10814648|NCT02675231|OG002|Outcome|8 mg/kg Trastuzumab + Standard of Care Chemotherapy|8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
10814649|NCT02675231|OG000|Outcome|150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant|150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
10814650|NCT02675231|EG000|Reported Event|150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant|150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
10814651|NCT02675231|EG001|Reported Event|150 mg Abemaciclib + 8 mg/kg Trastuzumab|150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
10814652|NCT02675231|EG002|Reported Event|8 mg/kg Trastuzumab + Standard of Care Chemotherapy|8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
10814653|NCT02634268|BG000|Baseline|Lifestyle Intervention|"Behavioral lifestyle intervention focused on healthy eating and physical activity~Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity"
10814654|NCT02634268|BG001|Baseline|Usual Care|Participants continue with usual diet and exercise activities as they desire
10814655|NCT02634268|BG002|Baseline|Total|Total of all reporting groups
10814656|NCT02634268|FG000|Participant Flow|Lifestyle Intervention|"Behavioral lifestyle intervention focused on healthy eating and physical activity~Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity"
10814657|NCT02634268|FG001|Participant Flow|Usual Care|Participants continue with usual diet and exercise activities as they desire
10814658|NCT02634268|OG000|Outcome|Lifestyle Intervention|"Behavioral lifestyle intervention focused on healthy eating and physical activity~Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity"
10814659|NCT02634268|OG001|Outcome|Usual Care|Participants continue with usual diet and exercise activities as they desire
10814660|NCT02634268|EG000|Reported Event|Lifestyle Intervention|"Behavioral lifestyle intervention focused on healthy eating and physical activity~Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity"
10814661|NCT02634268|EG001|Reported Event|Usual Care|Participants continue with usual diet and exercise activities as they desire
10814662|NCT02605967|BG000|Baseline|Spartalizumab 400 mg Q4W|anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab
10814663|NCT02605967|BG001|Baseline|Chemotherapy|Commonly used chemotherapy as per investigator's choice
10814664|NCT02605967|BG002|Baseline|Total|Total of all reporting groups
10814665|NCT02605967|FG000|Participant Flow|Spartalizumab 400 mg Q4W|anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab
10814666|NCT02605967|FG001|Participant Flow|Chemotherapy|Commonly used chemotherapy as per investigator's choice
10814667|NCT02605967|OG000|Outcome|Spartalizumab 400 mg Q4W|anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab
10814668|NCT02605967|OG001|Outcome|Chemotherapy|Commonly used chemotherapy as per investigator's choice
10814669|NCT02605967|OG000|Outcome|Crossover to Spartalizumab|Patients treated with chemotherapy who crossed over to spartalizumab
10814670|NCT02605967|OG002|Outcome|Crossover to Spartalizumab|Patients treated with chemotherapy who crossed over to spartalizumab
10814671|NCT02605967|EG000|Reported Event|Spartalizumab 400 mg Q4W|anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab
10814672|NCT02605967|EG001|Reported Event|Chemotherapy|Commonly used chemotherapy as per investigator's choice
10814673|NCT02605967|EG002|Reported Event|Crossover to Spartalizumab|Patients treated with chemotherapy who crossed over to spartalizumab
10814674|NCT02605967|EG003|Reported Event|All Spartalizumab Participants|All participants who received at least one dose of spartalizumab
11206281|NCT02234141|OG002|Outcome|Selonsertib 18 mg|Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11206282|NCT02234141|OG003|Outcome|Placebo|Participants received placebo tablet once daily for 24 weeks (Period 1).
11206283|NCT02234141|OG002|Outcome|Selonsertib 18 mg|Participants received selonsertib18 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
11244346|NCT02510001|OG002|Outcome|Dose Escalation Phase Dose 5a|"Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11244347|NCT02510001|OG000|Outcome|Dose Escalation Phase 5.|"Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. PF-02341066 200mg BD continuous administration~PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously~PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.~Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days"
11244348|NCT02510001|EG000|Reported Event|Dose Escalation Phase 1 PF-02341066 and PD-0325901|Dose Escalation Phase 1 - Crizotinib and PD-0325901
11244349|NCT02510001|EG001|Reported Event|Dose Escalation Phase 2 PF-0341066 and Binimetinib|Dose Escalation Phase 2 - Binimetinib and PF-02341066
11244350|NCT02510001|EG002|Reported Event|Dose Expansion Phase|Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
11244351|NCT02510014|BG000|Baseline|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
11244352|NCT02510014|BG001|Baseline|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
10814675|NCT02584634|BG000|Baseline|Group A: Avelumab + Crizotinib|Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg orally twice a day (BID) on a continuous daily dosing schedule.
10814676|NCT02584634|BG001|Baseline|Group B: Avelumab + Lorlatinib|Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814677|NCT02584634|BG002|Baseline|Total|Total of all reporting groups
10814678|NCT02584634|FG000|Participant Flow|Group A: Avelumab + Crizotinib|Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg orally twice a day (BID) on a continuous daily dosing schedule.
10814679|NCT02584634|FG001|Participant Flow|Group B: Avelumab + Lorlatinib|Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814680|NCT02584634|OG000|Outcome|Group A: Avelumab + Crizotinib|Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg orally twice a day (BID) on a continuous daily dosing schedule.
10814681|NCT02584634|OG001|Outcome|Group B: Avelumab + Lorlatinib|Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814682|NCT02584634|OG000|Outcome|Group B: Avelumab + Lorlatinib|Participants (treatment naive) with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814683|NCT02584634|OG000|Outcome|Group B: Avelumab + Lorlatinib|Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814684|NCT02584634|OG002|Outcome|All Participants|Including all the participants from Group A and Group B.
10814685|NCT02584634|EG000|Reported Event|Group A: Avelumab + Crizotinib|Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg orally twice a day (BID) on a continuous daily dosing schedule.
10814686|NCT02584634|EG001|Reported Event|Group B: Avelumab + Lorlatinib|Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg orally once a day (QD) on a continuous daily dosing schedule.
10814691|NCT02570503|BG000|Baseline|ROP/KET/CLON/EPI/SAL|"Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml~Ropivacaine: Ropivacaine (5mg/ml)-50ml~Ketorolac: ketorolac (30mg/ml)- 1 ml~Clonidine: clonidine (0.1mg/ml)- 0.8ml~Epinephrine: epinephrine (1mg/ml)-1ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814692|NCT02570503|BG001|Baseline|Placebo|"0.9% Sodium Chloride- 100ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814693|NCT02570503|BG002|Baseline|Total|Total of all reporting groups
10814694|NCT02570503|FG000|Participant Flow|ROP/KET/CLON/EPI/SAL|"Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml~Ropivacaine: Ropivacaine (5mg/ml)-50ml~Ketorolac: ketorolac (30mg/ml)- 1 ml~Clonidine: clonidine (0.1mg/ml)- 0.8ml~Epinephrine: epinephrine (1mg/ml)-1ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814695|NCT02570503|FG001|Participant Flow|Placebo|"0.9% Sodium Chloride- 100ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814696|NCT02570503|OG000|Outcome|ROP/KET/CLON/EPI/SAL|"Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml~Ropivacaine: Ropivacaine (5mg/ml)-50ml~Ketorolac: ketorolac (30mg/ml)- 1 ml~Clonidine: clonidine (0.1mg/ml)- 0.8ml~Epinephrine: epinephrine (1mg/ml)-1ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814697|NCT02570503|OG001|Outcome|Placebo|"0.9% Sodium Chloride- 100ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814698|NCT02570503|EG000|Reported Event|ROP/KET/CLON/EPI/SAL|"Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml~Ropivacaine: Ropivacaine (5mg/ml)-50ml~Ketorolac: ketorolac (30mg/ml)- 1 ml~Clonidine: clonidine (0.1mg/ml)- 0.8ml~Epinephrine: epinephrine (1mg/ml)-1ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
11244353|NCT02510014|BG002|Baseline|Total|Total of all reporting groups
11244354|NCT02510014|FG000|Participant Flow|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
11244355|NCT02510014|FG001|Participant Flow|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
11206284|NCT02234141|EG000|Reported Event|Selonsertib 2 mg|Participants received selonsertib 2 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 10 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 2 mg during the long-term treatment phase.
11206285|NCT02234141|EG001|Reported Event|Selonsertib 6 mg|Participants received selonsertib 6 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 12 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 6 mg during the long-term treatment phase.
11206286|NCT02234141|EG002|Reported Event|Selonsertib 18 mg|Participants received selonsertib 18 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 10 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 18 mg during the long-term treatment phase.
11206287|NCT02234141|EG003|Reported Event|Placebo|Participants received placebo tablet once daily for 24 weeks (Period 1). AEs reported in this group only include AEs that occurred during Period 1.
11206288|NCT02234180|BG000|Baseline|Arm I/II (Regorafenib/Placebo)|Within 6-12 weeks after surgery, patients receive regorafenib OR placebo PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11206289|NCT02234180|FG000|Participant Flow|Arm I (Regorafenib)|Within 6-12 weeks after surgery, patients will receive regorafenib PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11206290|NCT02234180|FG001|Participant Flow|Arm II (Placebo)|Within 6-12 weeks after surgery, patients will receive placebo PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11206291|NCT02234180|OG000|Outcome|Arm I/II (Regorafenib/Placebo)|Within 6-12 weeks after surgery, patients receive regorafenib OR placebo PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11206292|NCT02234180|EG000|Reported Event|Arm I/II (Regorafenib/Placebo)|Within 6-12 weeks after surgery, patients receive regorafenib OR placebo PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
11206293|NCT02234284|BG000|Baseline|Health Coaching|Coaching activities: Patient COPD education Correct use of inhalers and nebulizers Red flags and when to seek medical care Dyspnea management Use of oxygen Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations Ensuring appropriate preventive services (pneumovax, flu) Depression screening Reinforcing clinician education and use of treatment guidelines by primary care providers Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan Helping patients to make and keep appointments and obtain needed testing Facilitating communication between patients, pulmonary specialists and primary care providers Connecting with community resources Access to psychosocial services Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program Working with patient family members and caregivers
11206294|NCT02234284|BG001|Baseline|Usual Care|Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
11206295|NCT02234284|BG002|Baseline|Total|Total of all reporting groups
11206296|NCT02234284|FG000|Participant Flow|Health Coaching|"Major health coach activities:~Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a"
11206297|NCT02234284|FG001|Participant Flow|Usual Care|Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
11206298|NCT02234284|OG000|Outcome|Health Coaching|Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services ; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program ; Working with patient family members and caregivers
11206299|NCT02234284|OG001|Outcome|Usual Care|Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
11215459|NCT02299375|FG001|Participant Flow|Losmapimod 15 mg|Participants with COPD received losmapimod 15 mg tablets orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of ICS. Salbutamol MDI was provided as a rescue medication.
10814699|NCT02570503|EG001|Reported Event|Placebo|"0.9% Sodium Chloride- 100ml~0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml"
10814700|NCT02553265|BG000|Baseline|Low Dose Carbidopa, High Dose Carbidopa, Placebo|"This is a 14-week study. Patients will receive, in random order, high dose carbidopa (600mg/day), low dose carbidopa (300 mg/day) or placebo. Between each crossover, there will be a titration down over 2-days followed by a 2-day washout.~Carbidopa Low Dose~Placebo: A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.~Carbidopa High Dose"
10814701|NCT02553265|FG000|Participant Flow|Low-Dose Carbidopa, Then Placebo, Then High-Dose Carbidopa|Patients received low-dose carbidopa (300 mg/day), matching placebo, then high-dose carbidopa (600 mg/day) in 3 separate 4-week treatment periods. Doses were divided 3x daily, administered 6 hours apart, with a 4-day dose de-escalation and washout period between dose changes. in 3 separate 4-week treatment periods. Doses were divided 3x daily, administered 6 hours apart, with a 4-day dose de-escalation and washout period between dose changes.
10814702|NCT02553265|FG001|Participant Flow|High-Dose Carbidopa, Then Low-Dose Carbidopa, Then Placebo|Patients received high-dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), then matching placebo in 3 separate 4-week treatment periods. Doses were divided 3x daily, administered 6 hours apart, with a 4-day dose de-escalation and washout period between dose changes. in 3 separate 4-week treatment periods. Doses were divided 3x daily, administered 6 hours apart, with a 4-day dose de-escalation and washout period between dose changes.
10814703|NCT02553265|FG002|Participant Flow|Placebo, Then High-Dose Carbidopa, Then Low-Dose Carbidopa|Patients received matching placebo, high-dose carbidopa (600 mg/day), then low-dose carbidopa (300 mg/day) in 3 separate 4-week treatment periods. Doses were divided 3x daily, administered 6 hours apart, with a 4-day dose de-escalation and washout period between dose changes.
10814704|NCT02553265|OG000|Outcome|Placebo|A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.
10814705|NCT02553265|OG001|Outcome|Low-Dose Carbidopa|"300 mg/day~Other Names: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814706|NCT02553265|OG002|Outcome|High-Dose Carbidopa|"600 mg/day~Other Names: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814707|NCT02553265|OG001|Outcome|High-Dose Carbidopa|"600 mg/day~Other Names: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814708|NCT02553265|OG002|Outcome|Low-Dose Carbidopa|"300 mg/day~Other Name: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814709|NCT02553265|OG001|Outcome|High-Dose Carbidopa|"600 mg/day~Other Name: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814710|NCT02553265|EG000|Reported Event|Low-Dose Carbidopa|"300 mg/day~Other Name: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
11215460|NCT02299375|OG000|Outcome|Placebo|Participants with COPD received placebo orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of inhaled corticosteroid (ICS). Salbutamol metered dose inhaler (MDI) was provided as a rescue medication.
10814711|NCT02553265|EG001|Reported Event|High-Dose Carbidopa|"600 mg/day~Other Name: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486"
10814712|NCT02553265|EG002|Reported Event|Placebo|A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.
10814713|NCT02550288|BG000|Baseline|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
10814714|NCT02550288|BG001|Baseline|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
10814715|NCT02550288|BG002|Baseline|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
10814716|NCT02550288|BG003|Baseline|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
10814717|NCT02550288|BG004|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
10814718|NCT02550288|BG005|Baseline|Total|Total of all reporting groups
10814719|NCT02550288|FG000|Participant Flow|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
10814720|NCT02550288|FG001|Participant Flow|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
10814721|NCT02550288|FG002|Participant Flow|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
10814722|NCT02550288|FG003|Participant Flow|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
10814723|NCT02550288|FG004|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
10814724|NCT02550288|OG000|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
10814725|NCT02550288|OG001|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
10814726|NCT02550288|OG002|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
10814727|NCT02550288|OG003|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
10814728|NCT02550288|OG004|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
10814729|NCT02550288|EG000|Reported Event|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
10814730|NCT02550288|EG001|Reported Event|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
10814731|NCT02550288|EG002|Reported Event|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
10814732|NCT02550288|EG003|Reported Event|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
10814733|NCT02550288|EG004|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
10814734|NCT02510040|BG000|Baseline|Convergence Insufficiency|"Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814735|NCT02510040|BG001|Baseline|Divergence Insufficiency|"Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814736|NCT02510040|BG002|Baseline|Small-angle Hypertropia|"Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814737|NCT02510040|BG003|Baseline|Total|Total of all reporting groups
10814738|NCT02510040|FG000|Participant Flow|Convergence Insufficiency|"Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814739|NCT02510040|FG001|Participant Flow|Divergence Insufficiency|"Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814740|NCT02510040|FG002|Participant Flow|Small-angle Hypertropia|"Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10821997|NCT00073749|FG003|Participant Flow|Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10814741|NCT02510040|OG000|Outcome|Convergence Insufficiency|"Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814742|NCT02510040|OG001|Outcome|Divergence Insufficiency|"Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814743|NCT02510040|OG002|Outcome|Small-angle Hypertropia|"Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814744|NCT02510040|OG000|Outcome|Divergence Insufficiency|"Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814745|NCT02510040|EG000|Reported Event|Convergence Insufficiency|"Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814746|NCT02510040|EG001|Reported Event|Divergence Insufficiency|"Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814747|NCT02510040|EG002|Reported Event|Small-angle Hypertropia|"Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.~Prism: Ground-in or Fresnel prism~Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy~Eye Muscle Surgery: • Bilateral medial rectus muscle resection surgery~Single medial rectus muscle resection surgery~Recess lateral rectus muscle resection medial rectus muscle surgery~Bilateral lateral rectus muscle recession surgery~Single lateral rectus muscle recession surgery~Bilateral lateral rectus muscle resection surgery~Single lateral rectus muscle resection surgery~Recess medial rectus muscle resection lateral rectus muscle surgery~Bilateral medial rectus muscle recession surgery~Single medial rectus muscle recession surgery~Vertical rectus muscle recession surgery~Vertical rectus muscle mini-tenotomy (snip) surgery~Botox Injection: Botulinum toxin injection"
10814748|NCT02499328|BG000|Baseline|A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg|2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab
10814749|NCT02499328|BG001|Baseline|A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814750|NCT02499328|BG002|Baseline|A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg|40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
10814751|NCT02499328|BG003|Baseline|A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg|80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
10814752|NCT02499328|BG004|Baseline|A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg|80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab
10814753|NCT02499328|BG005|Baseline|A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814754|NCT02499328|BG006|Baseline|A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814755|NCT02499328|BG007|Baseline|A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814756|NCT02499328|BG008|Baseline|A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814757|NCT02499328|BG009|Baseline|B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814758|NCT02499328|BG010|Baseline|B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp|40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
10814759|NCT02499328|BG011|Baseline|B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814760|NCT02499328|BG012|Baseline|B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive|40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
11215461|NCT02299375|OG001|Outcome|Losmapimod 15 mg|Participants with COPD received losmapimod 15 mg tablets orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of ICS. Salbutamol MDI was provided as a rescue medication.
10814761|NCT02499328|BG013|Baseline|B5: AZD9150 3mg/kg|3 mg/kg QW danvatirsen IV
10814762|NCT02499328|BG014|Baseline|B6: AZD5069 40mg BID|40 mg BID AZD5069 (PO)
10814763|NCT02499328|BG015|Baseline|B6a: AZD5069 40mg BID Fed/Fasted|AZD5069 40mg BID (PO): Fed/Fasted
10814764|NCT02499328|BG016|Baseline|B6b: AZD5069 40mg BID Fasted/Fed|AZD5069 40mg BID (PO): Fasted/Fed
10814765|NCT02499328|BG017|Baseline|B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814766|NCT02499328|BG018|Baseline|B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W|400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab
10814767|NCT02499328|BG019|Baseline|Total|Total of all reporting groups
10814768|NCT02499328|FG000|Participant Flow|A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg|2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab
10814769|NCT02499328|FG001|Participant Flow|A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814770|NCT02499328|FG002|Participant Flow|A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg|40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
10814771|NCT02499328|FG003|Participant Flow|A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg|80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
10814772|NCT02499328|FG004|Participant Flow|A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg|80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab
10814773|NCT02499328|FG005|Participant Flow|A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814774|NCT02499328|FG006|Participant Flow|A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814775|NCT02499328|FG007|Participant Flow|A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
10814776|NCT02499328|FG008|Participant Flow|A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814777|NCT02499328|FG009|Participant Flow|B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814778|NCT02499328|FG010|Participant Flow|B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp|40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
10814779|NCT02499328|FG011|Participant Flow|B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814780|NCT02499328|FG012|Participant Flow|B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive|40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
10814781|NCT02499328|FG013|Participant Flow|B5: AZD9150 3mg/kg|3 mg/kg QW danvatirsen IV
10814782|NCT02499328|FG014|Participant Flow|B6: AZD5069 40mg BID|40 mg BID AZD5069 (PO)
10814783|NCT02499328|FG015|Participant Flow|B6a: AZD5069 40mg BID Fed/Fasted|AZD5069 40mg BID (PO): Fed/Fasted
10814784|NCT02499328|FG016|Participant Flow|B6b: AZD5069 40mg BID Fasted/Fed|AZD5069 40mg BID (PO): Fasted/Fed
10814785|NCT02499328|FG017|Participant Flow|B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
10814786|NCT02499328|FG018|Participant Flow|B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W|400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab
10814787|NCT02499328|OG000|Outcome|Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg|Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.
10814788|NCT02499328|OG001|Outcome|Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg|Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.
10814789|NCT02499328|OG002|Outcome|Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814790|NCT02499328|OG003|Outcome|Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814791|NCT02499328|OG004|Outcome|Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814792|NCT02499328|OG005|Outcome|Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
10814793|NCT02499328|OG000|Outcome|Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.
10814794|NCT02499328|OG001|Outcome|Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.
10814795|NCT02499328|OG002|Outcome|Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies
10814796|NCT02499328|OG000|Outcome|Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg|Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814797|NCT02499328|OG002|Outcome|Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814798|NCT02499328|OG003|Outcome|Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.
10814799|NCT02499328|OG004|Outcome|Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies
10814800|NCT02499328|OG005|Outcome|Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814801|NCT02499328|OG006|Outcome|Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814802|NCT02499328|OG007|Outcome|Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814803|NCT02499328|OG008|Outcome|Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
10814804|NCT02499328|OG000|Outcome|Part B1:AZD9150+MEDI4736:PDL1 Pretreated|Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814805|NCT02499328|OG001|Outcome|Part B2:AZD5069+MEDI4736:PDL1 Pretreated|Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814806|NCT02499328|OG002|Outcome|Part B3: AZD9150+MED4736:Naiive 2L|Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814807|NCT02499328|OG003|Outcome|Part B4:AZD5069+MEDI4736:Naiive Patients|Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814808|NCT02499328|OG004|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814809|NCT02499328|OG005|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814810|NCT02499328|OG001|Outcome|Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg|Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814811|NCT02499328|OG006|Outcome|Part B1:AZD9150+MEDI4736:PDL1 Pretreated|Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814812|NCT02499328|OG007|Outcome|Part B3: AZD9150+MED4736:Naiive 2L|Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814813|NCT02499328|OG008|Outcome|Part B5: AZD9150 in Naiive Patients|Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814814|NCT02499328|OG009|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814815|NCT02499328|OG010|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814816|NCT02499328|OG000|Outcome|Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814817|NCT02499328|OG001|Outcome|Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814818|NCT02499328|OG003|Outcome|Part B2:AZD5069+MEDI4736:PDL1 Pretreated|Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814819|NCT02499328|OG004|Outcome|Part B4:AZD5069+MEDI4736:Naiive Patients|Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814820|NCT02499328|OG005|Outcome|Part B6:AZD5069 in Naiive Patients|Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814821|NCT02499328|OG006|Outcome|Part B6a: AZD5069 40mg BID Fed/Fasted|Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814822|NCT02499328|OG007|Outcome|Part B6b: AZD5069 40mg BID Fasted/Fed|Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814823|NCT02499328|OG003|Outcome|Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg|Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.
10814824|NCT02499328|OG009|Outcome|Part B1:AZD9150+MEDI4736:PDL1 Pretreated|Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814825|NCT02499328|OG010|Outcome|Part B2:AZD5069+MEDI4736:PDL1 Pretreated|Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814826|NCT02499328|OG011|Outcome|Part B3: AZD9150+MED4736:Naiive 2L|Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814827|NCT02499328|OG012|Outcome|Part B4:AZD5069+MEDI4736:Naiive Patients|Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814828|NCT02499328|OG013|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814829|NCT02499328|OG013|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814830|NCT02499328|OG014|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814831|NCT02499328|OG000|Outcome|Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814832|NCT02499328|OG001|Outcome|Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814833|NCT02499328|OG002|Outcome|Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
10814834|NCT02499328|OG000|Outcome|Part A and B AZD9150 ADA|All subjects who received AZD9150 and provided ADA samples
10814835|NCT02499328|OG001|Outcome|Part A and B Durva ADA|All subjects who received durva and provided ADA samples.
10814836|NCT02499328|OG008|Outcome|Part A6: AZD9150/MEDI4736|Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
10814837|NCT02499328|OG004|Outcome|Part B5: AZD9150 in Naiive Patients|Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814838|NCT02499328|OG008|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814839|NCT02499328|OG009|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814840|NCT02499328|OG005|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814841|NCT02499328|OG006|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814842|NCT02499328|OG007|Outcome|Part B6b: AZD5069 40mg BID Fasted/Fed|Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814843|NCT02499328|OG007|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814844|NCT02499328|OG008|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814845|NCT02499328|OG001|Outcome|Part B3: AZD9150+MED4736:Naiive 2L|Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
10814846|NCT02499328|OG002|Outcome|Part B5: AZD9150 in Naiive Patients|Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
10814847|NCT02499328|OG003|Outcome|Part B7: AZD9150+MEDI4736: Naiive 1L|Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814848|NCT02499328|OG004|Outcome|Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L|Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
10814849|NCT02499328|EG000|Reported Event|A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg|Description (Arm-group)
10814850|NCT02499328|EG001|Reported Event|A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg|Description (Arm-group)
10814851|NCT02499328|EG002|Reported Event|A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg|Description (Arm-group)
10814852|NCT02499328|EG003|Reported Event|A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg|Description (Arm-group)
10814853|NCT02499328|EG004|Reported Event|A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg|Description (Arm-group)
10814854|NCT02499328|EG005|Reported Event|A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme|Description (Arm-group)
10814855|NCT02499328|EG006|Reported Event|A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme|Description (Arm-group)
10814856|NCT02499328|EG007|Reported Event|A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme|Description (Arm-group)
10814857|NCT02499328|EG008|Reported Event|A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|Description (Arm-group)
10814858|NCT02499328|EG009|Reported Event|B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp|Description (Arm-group)
10814859|NCT02499328|EG010|Reported Event|B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp|Description (Arm-group)
10814860|NCT02499328|EG011|Reported Event|B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive|Description (Arm-group)
10814861|NCT02499328|EG012|Reported Event|B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive|Description (Arm-group)
10814862|NCT02499328|EG013|Reported Event|B5: AZD9150 3mg/kg|Description (Arm-group)
10814863|NCT02499328|EG014|Reported Event|B6: AZD5069 40mg BID|Description (Arm-group)
10814864|NCT02499328|EG015|Reported Event|B6a: AZD5069 40mg BID Fed/Fasted|Description (Arm-group)
10814865|NCT02499328|EG016|Reported Event|B6b: AZD5069 40mg BID Fasted/Fed|Description (Arm-group)
10814866|NCT02499328|EG017|Reported Event|B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg|Description (Arm-group)
10814867|NCT02499328|EG018|Reported Event|B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W|Description (Arm-group)
10814868|NCT02463981|BG000|Baseline|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814869|NCT02463981|BG001|Baseline|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814870|NCT02463981|BG002|Baseline|Total|Total of all reporting groups
10814871|NCT02463981|FG000|Participant Flow|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814872|NCT02463981|FG001|Participant Flow|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814873|NCT02463981|OG000|Outcome|Neurofeedback Training|"Neurofeedback training group receives neurofeedback from their own anterior insula.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814874|NCT02463981|OG001|Outcome|Sham Control|"Sham control group receives sham neurofeedback from a large control brain region.~real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)"
10814875|NCT02463981|EG000|Reported Event|Neurofeedback Training|Subjects in this group received fMRI-based feedback from their insula activity
10814876|NCT02463981|EG001|Reported Event|Sham Control|Subjects in this group received fMRI-based feedback from a unspecific control region
10814877|NCT02460224|BG000|Baseline|Phase 1: LAG525 1 mg/kg Q2W|Single-agent LAG525 1 mg/kg Q2W
10814878|NCT02460224|BG001|Baseline|Phase 1: LAG525 3 mg/kg Q2W|Single-agent LAG525 3 mg/kg Q2W
10814879|NCT02460224|BG002|Baseline|Phase 1: LAG525 5 mg/kg Q2W|Single-agent LAG525 5 mg/kg Q2W
10814880|NCT02460224|BG003|Baseline|Phase 1: LAG525 10 mg/kg Q2W|Single-agent LAG525 10 mg/kg Q2W
10814881|NCT02460224|BG004|Baseline|Phase 1: LAG525 15 mg/kg Q2W|Single-agent LAG525 15 mg/kg Q2W
10814882|NCT02460224|BG005|Baseline|Phase 1: LAG525 240 mg Q2W|Single-agent LAG525 240 mg Q2W
10814883|NCT02460224|BG006|Baseline|Phase 1: LAG525 400 mg Q2W|Single-agent LAG525 400 mg Q2W
10814884|NCT02460224|BG007|Baseline|Phase 1: LAG525 3 mg/kg Q4W|Single-agent LAG525 3 mg/kg Q4W
10814885|NCT02460224|BG008|Baseline|Phase 1: LAG525 5 mg/kg Q4W|Single-agent LAG525 5 mg/kg Q4W
10814886|NCT02460224|BG009|Baseline|Phase 1: LAG525 10 mg/kg Q4W|Single-agent LAG525 10 mg/kg Q4W
10814887|NCT02460224|BG010|Baseline|Phase 1: LAG525 400 mg Q4W|Single-agent LAG525 400 mg Q4W
10814888|NCT02460224|BG011|Baseline|Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814889|NCT02460224|BG012|Baseline|Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814890|NCT02460224|BG013|Baseline|Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W|Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
10814891|NCT02460224|BG014|Baseline|Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
10814892|NCT02460224|BG015|Baseline|Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
10814893|NCT02460224|BG016|Baseline|Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
10814894|NCT02460224|BG017|Baseline|Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
10814895|NCT02460224|BG018|Baseline|Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
10814896|NCT02460224|BG019|Baseline|Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W|Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
10814897|NCT02460224|BG020|Baseline|Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
10814898|NCT02460224|BG021|Baseline|Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
10814899|NCT02460224|BG022|Baseline|Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
10814900|NCT02460224|BG023|Baseline|Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
10814901|NCT02460224|BG024|Baseline|Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
10814902|NCT02460224|BG025|Baseline|Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
10814903|NCT02460224|BG026|Baseline|Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
10814904|NCT02460224|BG027|Baseline|Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
10814905|NCT02460224|BG028|Baseline|Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
10814906|NCT02460224|BG029|Baseline|Total|Total of all reporting groups
10814907|NCT02460224|FG000|Participant Flow|Phase 1: LAG525 1 mg/kg Q2W|Single-agent LAG525 1 mg/kg Q2W
10814908|NCT02460224|FG001|Participant Flow|Phase 1: LAG525 3 mg/kg Q2W|Single-agent LAG525 3 mg/kg Q2W
10814909|NCT02460224|FG002|Participant Flow|Phase 1: LAG525 5 mg/kg Q2W|Single-agent LAG525 5 mg/kg Q2W
10814910|NCT02460224|FG003|Participant Flow|Phase 1: LAG525 10 mg/kg Q2W|Single-agent LAG525 10 mg/kg Q2W
10814911|NCT02460224|FG004|Participant Flow|Phase 1: LAG525 15 mg/kg Q2W|Single-agent LAG525 15 mg/kg Q2W
10814912|NCT02460224|FG005|Participant Flow|Phase 1: LAG525 240 mg Q2W|Single-agent LAG525 240 mg Q2W
10814913|NCT02460224|FG006|Participant Flow|Phase 1: LAG525 400 mg Q2W|Single-agent LAG525 400 mg Q2W
10814914|NCT02460224|FG007|Participant Flow|Phase 1: LAG525 3 mg/kg Q4W|Single-agent LAG525 3 mg/kg Q4W
10814915|NCT02460224|FG008|Participant Flow|Phase 1: LAG525 5 mg/kg Q4W|Single-agent LAG525 5 mg/kg Q4W
10814916|NCT02460224|FG009|Participant Flow|Phase 1: LAG525 10 mg/kg Q4W|Single-agent LAG525 10 mg/kg Q4W
10814917|NCT02460224|FG010|Participant Flow|Phase 1: LAG525 400 mg Q4W|Single-agent LAG525 400 mg Q4W
10814918|NCT02460224|FG011|Participant Flow|Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814919|NCT02460224|FG012|Participant Flow|Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814920|NCT02460224|FG013|Participant Flow|Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W|Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
10814921|NCT02460224|FG014|Participant Flow|Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
10814922|NCT02460224|FG015|Participant Flow|Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
10814923|NCT02460224|FG016|Participant Flow|Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
11206300|NCT02234284|OG000|Outcome|Health Coaching|"Major health coach activities:~Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a"
11206301|NCT02234284|OG001|Outcome|Usual Care|Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
11206302|NCT02234284|OG000|Outcome|Health Coaching|Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medic al care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services ; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program ; Working with patient family members and caregivers
10814924|NCT02460224|FG017|Participant Flow|Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
10814925|NCT02460224|FG018|Participant Flow|Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
10814926|NCT02460224|FG019|Participant Flow|Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W|Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
10814927|NCT02460224|FG020|Participant Flow|Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
10814928|NCT02460224|FG021|Participant Flow|Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
10814929|NCT02460224|FG022|Participant Flow|Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
11206303|NCT02234284|OG001|Outcome|Usual Care|Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
10814930|NCT02460224|FG023|Participant Flow|Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
10814931|NCT02460224|FG024|Participant Flow|Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
10814932|NCT02460224|FG025|Participant Flow|Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
10814933|NCT02460224|FG026|Participant Flow|Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
10814934|NCT02460224|FG027|Participant Flow|Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
10814935|NCT02460224|FG028|Participant Flow|Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
10814936|NCT02460224|OG000|Outcome|Phase 1: LAG525 1 mg/kg Q2W|Single-agent LAG525 1 mg/kg Q2W
10814937|NCT02460224|OG001|Outcome|Phase 1: LAG525 3 mg/kg Q2W|Single-agent LAG525 3 mg/kg Q2W
10814938|NCT02460224|OG002|Outcome|Phase 1: LAG525 5 mg/kg Q2W|Single-agent LAG525 5 mg/kg Q2W
10814939|NCT02460224|OG003|Outcome|Phase 1: LAG525 10 mg/kg Q2W|Single-agent LAG525 10 mg/kg Q2W
10814940|NCT02460224|OG004|Outcome|Phase 1: LAG525 15 mg/kg Q2W|Single-agent LAG525 15 mg/kg Q2W
10814941|NCT02460224|OG005|Outcome|Phase 1: LAG525 240 mg Q2W|Single-agent LAG525 240 mg Q2W
10814942|NCT02460224|OG006|Outcome|Phase 1: LAG525 400 mg Q2W|Single-agent LAG525 400 mg Q2W
10814943|NCT02460224|OG007|Outcome|Phase 1: LAG525 3 mg/kg Q4W|Single-agent LAG525 3 mg/kg Q4W
10814944|NCT02460224|OG008|Outcome|Phase 1: LAG525 5 mg/kg Q4W|Single-agent LAG525 5 mg/kg Q4W
10814945|NCT02460224|OG009|Outcome|Phase 1: LAG525 10 mg/kg Q4W|Single-agent LAG525 10 mg/kg Q4W
10814946|NCT02460224|OG010|Outcome|Phase 1: LAG525 400 mg Q4W|Single-agent LAG525 400 mg Q4W
10814947|NCT02460224|OG011|Outcome|Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814948|NCT02460224|OG012|Outcome|Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814949|NCT02460224|OG013|Outcome|Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W|Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
10814950|NCT02460224|OG014|Outcome|Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
10814951|NCT02460224|OG015|Outcome|Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
10814952|NCT02460224|OG016|Outcome|Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
10814953|NCT02460224|OG017|Outcome|Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
10814954|NCT02460224|OG018|Outcome|Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
10814955|NCT02460224|OG019|Outcome|Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W|Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
10814956|NCT02460224|OG020|Outcome|Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
10814957|NCT02460224|OG021|Outcome|Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
10814958|NCT02460224|OG022|Outcome|Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
10814959|NCT02460224|OG023|Outcome|Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
10814960|NCT02460224|OG024|Outcome|Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
10814961|NCT02460224|OG025|Outcome|Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
10814962|NCT02460224|OG000|Outcome|Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
10814963|NCT02460224|OG001|Outcome|Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
10814964|NCT02460224|OG002|Outcome|Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
10814965|NCT02460224|EG000|Reported Event|Phase 1: LAG525 1 mg/kg Q2W|Single-agent LAG525 1 mg/kg Q2W (ROW patients)
10814966|NCT02460224|EG001|Reported Event|Phase 1: LAG525 3 mg/kg Q2W|Single-agent LAG525 3 mg/kg Q2W
10814967|NCT02460224|EG002|Reported Event|Phase 1: LAG525 5 mg/kg Q2W|Single-agent LAG525 5 mg/kg Q2W
10814968|NCT02460224|EG003|Reported Event|Phase 1: LAG525 10 mg/kg Q2W|Single-agent LAG525 10 mg/kg Q2W
10814969|NCT02460224|EG004|Reported Event|Phase 1: LAG525 15 mg/kg Q2W|Single-agent LAG525 15 mg/kg Q2W
10814970|NCT02460224|EG005|Reported Event|Phase 1: LAG525 240 mg Q2W|Single-agent LAG525 240 mg Q2W (ROW patients)
10814971|NCT02460224|EG006|Reported Event|Phase 1: LAG525 400 mg Q2W|Single-agent LAG525 400 mg Q2W (ROW patients)
10814972|NCT02460224|EG007|Reported Event|Phase 1: LAG525 1 mg/kg Q2W-JP|Single-agent LAG525 1 mg/kg Q2W (Japanese patients)
10814973|NCT02460224|EG008|Reported Event|Phase 1: LAG525 240 mg Q2W-JP|Single-agent LAG525 240 mg Q2W (Japanese patients)
10814974|NCT02460224|EG009|Reported Event|Phase 1: LAG525 400 mg Q2W-JP|Single-agent LAG525 400 mg Q2W (Japanese patients)
10814975|NCT02460224|EG010|Reported Event|Phase 1: LAG525 3 mg/kg Q4W|Single-agent LAG525 3 mg/kg Q4W
10814976|NCT02460224|EG011|Reported Event|Phase 1: LAG525 5 mg/kg Q4W|Single-agent LAG525 5 mg/kg Q4W
10814977|NCT02460224|EG012|Reported Event|Phase 1: LAG525 10 mg/kg Q4W|Single-agent LAG525 10 mg/kg Q4W
10814978|NCT02460224|EG013|Reported Event|Phase 1: LAG525 400 mg Q4W|Single-agent LAG525 400 mg Q4W
10814979|NCT02460224|EG014|Reported Event|Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814980|NCT02460224|EG015|Reported Event|Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W|Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
10814981|NCT02460224|EG016|Reported Event|Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W|Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
10814982|NCT02460224|EG017|Reported Event|Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
10814983|NCT02460224|EG018|Reported Event|Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W|Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
10814984|NCT02460224|EG019|Reported Event|Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
10814985|NCT02460224|EG020|Reported Event|Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
10814986|NCT02460224|EG021|Reported Event|Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
10814987|NCT02460224|EG022|Reported Event|Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W|Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
10814988|NCT02460224|EG023|Reported Event|Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
10814989|NCT02460224|EG024|Reported Event|Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
10814990|NCT02460224|EG025|Reported Event|Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
10814991|NCT02460224|EG026|Reported Event|Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
10814992|NCT02460224|EG027|Reported Event|Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
10814993|NCT02460224|EG028|Reported Event|Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W|Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
10814994|NCT02460224|EG029|Reported Event|Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC naïve to anti-PD-1/PD-L1
10814995|NCT02460224|EG030|Reported Event|Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma naïve to anti-PD-1/PD-L1
10814996|NCT02460224|EG031|Reported Event|Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC naïve to anti-PD-1/PD-L1
10814997|NCT02460224|EG032|Reported Event|Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma naïve to anti-PD-1/PD-L1
10814998|NCT02460224|EG033|Reported Event|Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC naïve to anti-PD-1/PD-L1
10814999|NCT02460224|EG034|Reported Event|Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W|Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients with TNBC naïve to anti-PD-1/PD-L1
10815000|NCT02460224|EG035|Reported Event|Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC pre-treated with anti-PD-1/PD-L1
10815001|NCT02460224|EG036|Reported Event|Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma pre-treated with anti-PD-1/PD-L1
10815002|NCT02460224|EG037|Reported Event|Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC pre-treated with anti-PD-1/PD-L1
10815003|NCT02460224|EG038|Reported Event|Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma pre-treated with anti-PD-1/PD-L1
10815004|NCT02460224|EG039|Reported Event|Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W|Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC pre-treated with anti-PD-1/PD-L1
10815005|NCT02460224|EG040|Reported Event|All Patients|All patients
10815006|NCT02460159|BG000|Baseline|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815007|NCT02460159|BG001|Baseline|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815008|NCT02460159|BG002|Baseline|Total|Total of all reporting groups
10815009|NCT02460159|FG000|Participant Flow|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815010|NCT02460159|FG001|Participant Flow|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815011|NCT02460159|OG000|Outcome|EZ 10 mg/Atorva 10 mg FDC|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815012|NCT02460159|OG001|Outcome|EZ 10 mg/Atorva 20 mg FDC|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815013|NCT02460159|EG000|Reported Event|EZ10/AT10|One ezetimibe (EZ) 10 mg/atorvastatin (Atorva) 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815014|NCT02460159|EG001|Reported Event|EZ10/AT20|One EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
10815015|NCT02457910|BG000|Baseline|PH1b E+T - Level 1 (Cohort 1)|Enzalutamide and Taselisib taken daily by mouth
10815016|NCT02457910|BG001|Baseline|PH1b E+T - Level 2 (Cohort 1 and 2)|Enzalutamide and Taselisib taken daily by mouth
10815017|NCT02457910|BG002|Baseline|PH1b E+T - Level 3 (Cohort 1)|Enzalutamide and Taselisib taken daily by mouth
10815018|NCT02457910|BG003|Baseline|PH1b E+T - Level 4 (Cohort 1)|Enzalutamide and Taselisib taken daily by mouth
10815019|NCT02457910|BG004|Baseline|PHII Enzalutamide|Enzalutamide taken daily by mouth
10815020|NCT02457910|BG005|Baseline|Phase II E+T|Enzalutamide and Taselisib taken daily by mouth
10815021|NCT02457910|BG006|Baseline|Total|Total of all reporting groups
10815022|NCT02457910|FG000|Participant Flow|PH1b E+T - Level 1 (Cohort 1)|Enzalutamide 160 mg PO daily and 2 mg Taselisib PO daily
10815023|NCT02457910|FG001|Participant Flow|PH1b E+T - Level 2 (Cohort 1 and 2)|Enzalutamide 160 mg PO daily and Taselisib 4 mg PO daily
10815024|NCT02457910|FG002|Participant Flow|PH1b E+T - Level 3 (Cohort 1)|Enzalutamide 160 mg PO daily and Taselisib 6 mg PO daily
10815025|NCT02457910|FG003|Participant Flow|PH1b E+T - Level 4 (Cohort 1)|Enzalutamide 160 mg PO daily and Taselisib 8 mg PO daily
10815026|NCT02457910|FG004|Participant Flow|PHII Enzalutamide|Enzalutamide 160mg PO daily
10815027|NCT02457910|FG005|Participant Flow|Phase II E+T|Enzalutamide 160mg PO daily and Taselisib 4 mg PO daily
10815028|NCT02457910|OG000|Outcome|Arm I (Taselisib, Enzalutamide)|Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815029|NCT02457910|OG001|Outcome|Arm II (Enzalutamide)|Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to Arm I.
10815030|NCT02457910|OG000|Outcome|2mg Taselisib and 160mg Enzalutamide|"Patients receive 2mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.~160 mg enzalutamide were administered in combination with taselisib starting dose of 2 mg and escalated to 4 mg, 6 mg and 8 mg in a traditional 3+3 trial design."
10815031|NCT02457910|OG001|Outcome|4mg Taselisib and 160mg Enzalutamide|Patients receive 4mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815032|NCT02457910|OG002|Outcome|6mg Taselisib and 160mg Enzalutamide|Patients receive 6mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815033|NCT02457910|OG003|Outcome|8mg Taselisib and 160mg Enzalutamide|Patients receive8mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815034|NCT02457910|OG000|Outcome|Patients Received Both Enzalutamide and Taselisib|Patients received enzalutamide and taselisib from phase I and phase II and evaluable
10815035|NCT02457910|OG000|Outcome|Combination of Taselisib and Enzalutamide|"Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.~160 mg enzalutamide were administered in combination with taselisib starting dose of 2 mg and escalated to 4 mg, 6 mg and 8 mg in a traditional 3+3 trial design."
10815036|NCT02457910|EG000|Reported Event|Taselisib 2 mg|Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815037|NCT02457910|EG001|Reported Event|Taselisib 4 mg|Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815038|NCT02457910|EG002|Reported Event|Taselisib 6 mg|Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815039|NCT02457910|EG003|Reported Event|Taselisib 8 mg|Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
10815040|NCT02457910|EG004|Reported Event|Enzalutamide|Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to receive Enzalutamide + Taselisib
10815041|NCT02457910|EG005|Reported Event|Enzalutamide + Taselisib|Patients receive enzalutamide PO QD starting on day 1 of cycle 1, and will receive PO QD Taselisib on day 1 of cycle 2.
10815042|NCT02457910|EG006|Reported Event|Cross-Over|Upon progression of disease, patients on the enzalutamide only arm will be allowed to crossover to enzalutamide + taselisib (must begin no later than 21 days after the clinic visit at which disease progression is determined) Enzalutamide and Taselisib will be taken PO QD
10815043|NCT02407236|BG000|Baseline|Induction Study (IS): Placebo Intravenous (IV)|Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815044|NCT02407236|BG001|Baseline|IS: Ustekinumab 130 Milligram (mg) IV|Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815045|NCT02407236|BG002|Baseline|IS: Ustekinumab Approximately 6 mg/kg IV|Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815046|NCT02407236|BG003|Baseline|Maintenance Study (MS): Placebo Subcutaneous (SC)|Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
10815047|NCT02407236|BG004|Baseline|MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
11206304|NCT02234284|EG000|Reported Event|Health Coaching|Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers
11206305|NCT02234284|EG001|Reported Event|Usual Care|Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling
10815048|NCT02407236|BG005|Baseline|MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
10815049|NCT02407236|BG006|Baseline|MS: Placebo IV (IS - Responders) to Placebo SC|Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815050|NCT02407236|BG007|Baseline|MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w|Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815051|NCT02407236|BG008|Baseline|Total|Total of all reporting groups
10815052|NCT02407236|FG000|Participant Flow|Induction Study (IS): Placebo Intravenous (IV)|Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815053|NCT02407236|FG001|Participant Flow|IS: Ustekinumab 130 Milligram (mg) IV|Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815054|NCT02407236|FG002|Participant Flow|IS: Ustekinumab Approximately 6 mg/kg IV|Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815055|NCT02407236|FG003|Participant Flow|Maintenance Study (MS): Placebo Subcutaneous (SC)|Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
10815056|NCT02407236|FG004|Participant Flow|MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
10815057|NCT02407236|FG005|Participant Flow|MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
10815058|NCT02407236|FG006|Participant Flow|MS: Placebo IV (IS - Responders) to Placebo SC|Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815059|NCT02407236|FG007|Participant Flow|MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w|Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815060|NCT02407236|OG000|Outcome|Induction Study (IS): Placebo Intravenous (IV)|Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10821998|NCT00073749|FG004|Participant Flow|Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5|Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10815061|NCT02407236|OG001|Outcome|IS: Ustekinumab 130 Milligram (mg) IV|Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815062|NCT02407236|OG002|Outcome|IS: Ustekinumab Approximately 6 mg/kg IV|Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
10815063|NCT02407236|OG000|Outcome|Maintenance Study (MS): Placebo Subcutaneous (SC)|Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
10815064|NCT02407236|OG001|Outcome|MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
10815065|NCT02407236|OG002|Outcome|MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
10815066|NCT02407236|EG000|Reported Event|Induction Study (IS): Placebo Intravenous (IV)|Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Included data up to Week 8 for participants who received ustekinumab at Week 8.
10815067|NCT02407236|EG001|Reported Event|IS: Ustekinumab 130 Milligram (mg) IV|Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Included data up to Week 8 for participants who received ustekinumab at Week 8.
10815068|NCT02407236|EG002|Reported Event|IS: Ustekinumab Approximately 6 mg/kg IV|Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent. Included data up to Week 8 for participants who received ustekinumab at Week 8.
10815069|NCT02407236|EG003|Reported Event|Placebo Non-responders at Week 8 Induction|Participants who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.
11092522|NCT01540474|BG000|Baseline|Group 1: 10 ug FMP012 With 2 ug GLA-SE|"Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant"
11215462|NCT02299375|OG000|Outcome|Losmapimod 15 mg|Participants with COPD received losmapimod 15 mg tablets orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of ICS. Salbutamol MDI was provided as a rescue medication.
10815070|NCT02407236|EG004|Reported Event|Ustekinumab Non-responders at Week 8 Induction|Participants who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Participants with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.
10815071|NCT02407236|EG005|Reported Event|Maintenance Study (MS): Placebo Subcutaneous (SC)|Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.
10815072|NCT02407236|EG006|Reported Event|MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.
10815073|NCT02407236|EG007|Reported Event|MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)|Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
10815074|NCT02407236|EG008|Reported Event|MS: Placebo IV (IS - Responders) to Placebo SC|Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815075|NCT02407236|EG009|Reported Event|MS:Ustekinumab Delayed Responder(IS) to Ustekinumab 90mgSC q8w|Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16) received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).
10815076|NCT02320396|BG000|Baseline|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815077|NCT02320396|BG001|Baseline|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815078|NCT02320396|BG002|Baseline|Total|Total of all reporting groups
10815079|NCT02320396|FG000|Participant Flow|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815080|NCT02320396|FG001|Participant Flow|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815081|NCT02320396|OG000|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815082|NCT02320396|OG001|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815083|NCT02320396|EG000|Reported Event|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10815084|NCT02320396|EG001|Reported Event|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
10821999|NCT00073749|FG005|Participant Flow|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10822000|NCT00073749|FG006|Participant Flow|Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10822001|NCT00073749|OG000|Outcome|Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5|Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822002|NCT00073749|OG001|Outcome|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10815085|NCT02282345|BG000|Baseline|Talazoparib - (2 Months)|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care chemotherapy.
10815086|NCT02282345|BG001|Baseline|Expansion Arm (Talazoparib (6 Months) + Surgery)|Talazoparib will be administered orally at 1 mg per day for at least 4 and up to 6 cycles. Each cycle will consist of 28 days (+/-3 days) followed by surgery or standard of care chemotherapy.
10815087|NCT02282345|BG002|Baseline|Total|Total of all reporting groups
10815088|NCT02282345|FG000|Participant Flow|Talazoparib (2 Months)|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care chemotherapy.
10815089|NCT02282345|FG001|Participant Flow|Expansion Arm Talazoparib (6 Months) + Surgery|Talazoparib will be administered orally at 1 mg per day for at least 4 and up to 6 cycles. Each cycle will consist of 28 days (+/-3 days) followed by surgery or standard of care chemotherapy.
10815090|NCT02282345|OG000|Outcome|Talazoparib (2 Months) +(SOC) Chemotherapy|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care (SOC) chemotherapy.
10815091|NCT02282345|OG001|Outcome|Expansion Arm Talazoparib (6 Months) + Surgery|Talazoparib will be administered orally at 1 mg per day for at least 4 and up to 6 cycles. Each cycle will consist of 28 days (+/-3 days) followed by surgery or standard of care chemotherapy.
11206306|NCT02234362|BG000|Baseline|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
11206307|NCT02234362|FG000|Participant Flow|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
10815092|NCT02282345|OG000|Outcome|Talazoparib - (2 Months) + (SOC) Chemotherapy.|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care (SOC)chemotherapy.
10815093|NCT02282345|OG001|Outcome|Expansion Arm (Talazoparib (6 Months) + Surgery)|Talazoparib will be administered orally at 1 mg per day for at least 4 and up to 6 cycles. Each cycle will consist of 28 days (+/-3 days) followed by surgery or standard of care chemotherapy.
10815094|NCT02282345|OG000|Outcome|Talazoparib (2 Months)|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care (SOC) chemotherapy.
10815095|NCT02282345|EG000|Reported Event|Talazoparib (2 Months)|Talazoparib was administered as single-agent oral dose of 1 mg per day for six cycles (each cycle was 28 days) for 2 months followed by standard of care chemotherapy.
10815096|NCT02282345|EG001|Reported Event|Expansion Arm Talazoparib (6 Months) + Surgery|Talazoparib will be administered orally at 1 mg per day for at least 4 and up to 6 cycles. Each cycle will consist of 28 days (+/-3 days) followed by surgery or standard of care chemotherapy.
10815097|NCT02230410|BG000|Baseline|Focal Cryo Ablation|"Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment~CryoBalloon Focal Ablation"
11206308|NCT02234362|OG000|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
11206309|NCT02234362|EG000|Reported Event|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
11206310|NCT02234427|BG000|Baseline|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
11206311|NCT02234427|FG000|Participant Flow|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
11206312|NCT02234427|OG000|Outcome|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
11206313|NCT02234427|EG000|Reported Event|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
11206314|NCT02234479|BG000|Baseline|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
11206315|NCT02234479|BG001|Baseline|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
11206316|NCT02234479|BG002|Baseline|Total|Total of all reporting groups
11206317|NCT02234479|FG000|Participant Flow|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
11206318|NCT02234479|FG001|Participant Flow|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
11206319|NCT02234479|OG000|Outcome|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
11206320|NCT02234479|OG001|Outcome|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
11206321|NCT02234479|EG000|Reported Event|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
11206322|NCT02234479|EG001|Reported Event|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
11206323|NCT02234570|BG000|Baseline|0.5 mg/kg Oxfendazole|Participants received a single oral dose 0.5 mg/kg of oxfendazole.
11206324|NCT02234570|BG001|Baseline|1 mg/kg Oxfendazole|Participants received a single oral dose 1 mg/kg of oxfendazole
11206325|NCT02234570|BG002|Baseline|3 mg/kg Oxfendazole|Participants received a single oral dose 3 mg/kg of oxfendazole
10815098|NCT02230410|FG000|Participant Flow|Focal Cryo Ablation|"Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment~CryoBalloon Focal Ablation"
10815099|NCT02230410|OG000|Outcome|Focal Cryo Ablation|"Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment~CryoBalloon Focal Ablation"
10815100|NCT02230410|EG000|Reported Event|Focal Cryo Ablation|"Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment~CryoBalloon Focal Ablation"
10815101|NCT02053246|BG000|Baseline|Nebivolol|"Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.~Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated."
10815102|NCT02053246|FG000|Participant Flow|Nebivolol|"Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.~Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated."
10815103|NCT02053246|OG000|Outcome|Nebivolol|"Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.~Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated."
10815104|NCT02053246|EG000|Reported Event|Nebivolol|"Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.~Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated."
10815105|NCT01980940|BG000|Baseline|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
10815106|NCT01980940|BG001|Baseline|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
10815107|NCT01980940|BG002|Baseline|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
10815108|NCT01980940|BG003|Baseline|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
10815109|NCT01980940|BG004|Baseline|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
10815110|NCT01980940|BG005|Baseline|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
10815111|NCT01980940|BG006|Baseline|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
10815112|NCT01980940|BG007|Baseline|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
10815113|NCT01980940|BG008|Baseline|Total|Total of all reporting groups
10815114|NCT01980940|FG000|Participant Flow|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
10815115|NCT01980940|FG001|Participant Flow|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
10815116|NCT01980940|FG002|Participant Flow|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
10815117|NCT01980940|FG003|Participant Flow|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
10815118|NCT01980940|FG004|Participant Flow|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
10815119|NCT01980940|FG005|Participant Flow|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
10815120|NCT01980940|FG006|Participant Flow|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
10815121|NCT01980940|FG007|Participant Flow|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
10815122|NCT01980940|OG000|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
10815123|NCT01980940|OG001|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
10815124|NCT01980940|OG002|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
10815125|NCT01980940|OG003|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
10815126|NCT01980940|OG004|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
10815127|NCT01980940|OG005|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
10815128|NCT01980940|OG000|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
10815129|NCT01980940|OG001|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
10815130|NCT01980940|OG001|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
10815131|NCT01980940|OG002|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
10815132|NCT01980940|OG003|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
10815133|NCT01980940|OG004|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
10815134|NCT01980940|OG006|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
10815135|NCT01980940|OG007|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
10815136|NCT01980940|EG000|Reported Event|ETOR 75 DMSO (Pt 1)|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
10815137|NCT01980940|EG001|Reported Event|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
10815138|NCT01980940|EG002|Reported Event|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
10815139|NCT01980940|EG003|Reported Event|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
10815140|NCT01980940|EG004|Reported Event|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
10815141|NCT01980940|EG005|Reported Event|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
10815142|NCT01980940|EG006|Reported Event|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
10815143|NCT01980940|EG007|Reported Event|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
10815144|NCT01923298|BG000|Baseline|Estradiol|ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
10815145|NCT01923298|FG000|Participant Flow|Estradiol|ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
10815146|NCT01923298|OG000|Outcome|Estring Group|ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
10815147|NCT01923298|EG000|Reported Event|Estradiol|ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
10815148|NCT01918033|BG000|Baseline|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
10815149|NCT01918033|BG001|Baseline|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
10815150|NCT01918033|BG002|Baseline|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
10815151|NCT01918033|BG003|Baseline|Total|Total of all reporting groups
11206326|NCT02234570|BG003|Baseline|7.5 mg/kg Oxfendazole|Participants received a single oral dose 7.5 mg/kg of oxfendazole
11206327|NCT02234570|BG004|Baseline|15 mg/kg Oxfendazole|Participants received a single oral dose 15 mg/kg of oxfendazole
11206328|NCT02234570|BG005|Baseline|30 mg/kg Oxfendazole|Participants received a single oral dose 30 mg/kg of oxfendazole
10815152|NCT01918033|FG000|Participant Flow|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
10815153|NCT01918033|FG001|Participant Flow|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
10815154|NCT01918033|FG002|Participant Flow|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
10815155|NCT01918033|OG000|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
10815156|NCT01918033|OG001|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
10815157|NCT01918033|OG002|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
10815158|NCT01918033|EG000|Reported Event|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
10815159|NCT01918033|EG001|Reported Event|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
10815160|NCT01918033|EG002|Reported Event|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
10815161|NCT01916980|BG000|Baseline|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
11206329|NCT02234570|BG006|Baseline|60 mg/kg Oxfendazole|Participants received a single oral dose 60 mg/kg of oxfendazole
11206330|NCT02234570|BG007|Baseline|Placebo|Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
11206331|NCT02234570|BG008|Baseline|Total|Total of all reporting groups
11206332|NCT02234570|FG000|Participant Flow|0.5 mg/kg Oxfendazole|Participants received a single oral dose 0.5 mg/kg of oxfendazole.
10815162|NCT01916980|BG001|Baseline|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815163|NCT01916980|BG002|Baseline|Total|Total of all reporting groups
10815164|NCT01916980|FG000|Participant Flow|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815165|NCT01916980|FG001|Participant Flow|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815166|NCT01916980|OG000|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815167|NCT01916980|OG001|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815168|NCT01916980|EG000|Reported Event|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815169|NCT01916980|EG001|Reported Event|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
10815170|NCT01916967|BG000|Baseline|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
11206333|NCT02234570|FG001|Participant Flow|1 mg/kg Oxfendazole|Participants received a single oral dose 1 mg/kg of oxfendazole
10815171|NCT01916967|BG001|Baseline|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
10815172|NCT01916967|BG002|Baseline|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
10815173|NCT01916967|BG003|Baseline|Total|Total of all reporting groups
10815174|NCT01916967|FG000|Participant Flow|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
10815175|NCT01916967|FG001|Participant Flow|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
10815176|NCT01916967|FG002|Participant Flow|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
10815177|NCT01916967|OG000|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
10815178|NCT01916967|OG001|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
10815179|NCT01916967|OG002|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
10815180|NCT01916967|OG003|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
10815181|NCT01916967|EG000|Reported Event|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
10815182|NCT01916967|EG001|Reported Event|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
10815183|NCT01916967|EG002|Reported Event|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
10815184|NCT01916967|EG003|Reported Event|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
10822003|NCT00073749|OG000|Outcome|Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5|Participants with CD22-positive B-cell NHL received either 0.4, 0.8, 1.34, 1.8 or 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
11206334|NCT02234570|FG002|Participant Flow|3 mg/kg Oxfendazole|Participants received a single oral dose 3 mg/kg of oxfendazole
11206335|NCT02234570|FG003|Participant Flow|7.5 mg/kg Oxfendazole|Participants received a single oral dose 7.5 mg/kg of oxfendazole
11206336|NCT02234570|FG004|Participant Flow|15 mg/kg Oxfendazole|Participants received a single oral dose 15 mg/kg of oxfendazole
11206337|NCT02234570|FG005|Participant Flow|30 mg/kg Oxfendazole|Participants received a single oral dose 30 mg/kg of oxfendazole
11206338|NCT02234570|FG006|Participant Flow|60 mg/kg Oxfendazole|Participants received a single oral dose 60 mg/kg of oxfendazole
10815185|NCT01910402|BG000|Baseline|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
10815186|NCT01910402|BG001|Baseline|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
10815187|NCT01910402|BG002|Baseline|Total|Total of all reporting groups
10815188|NCT01910402|FG000|Participant Flow|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
10815189|NCT01910402|FG001|Participant Flow|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
10815190|NCT01910402|OG000|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
10815191|NCT01910402|OG001|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
10815192|NCT01910402|OG000|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
10815193|NCT01910402|OG000|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
10815194|NCT01910402|EG000|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated.
10815195|NCT01910402|EG001|Reported Event|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
10815196|NCT01893320|BG000|Baseline|Phase I MTD Vosaroxin|The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
10815197|NCT01893320|BG001|Baseline|Vosaroxin + Decitabine|"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).~Following the phase I portion, patients in phase II receive the following induction:~Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.~Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.~Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.~Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.~Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5)."
10815198|NCT01893320|BG002|Baseline|Total|Total of all reporting groups
10815199|NCT01893320|FG000|Participant Flow|Phase I MTD Vosaroxin|The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
10822004|NCT00073749|OG000|Outcome|Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1|Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
11206339|NCT02234570|FG007|Participant Flow|Placebo|Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
10815200|NCT01893320|FG001|Participant Flow|Vosaroxin + Decitabine|"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).~Following the phase I portion, patients in phase II receive the following induction:~Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.~Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.~Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.~Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.~Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5)."
10815201|NCT01893320|OG000|Outcome|Phase I MTD Vosaroxin|The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
10815202|NCT01893320|OG001|Outcome|Vosaroxin + Decitabine|"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).~Following the phase I portion, patients in phase II receive the following induction:~Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.~Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.~Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.~Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.~Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5)."
10815203|NCT01893320|EG000|Reported Event|Phase I MTD Vosaroxin|The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
10815204|NCT01893320|EG001|Reported Event|Vasoroxin + Decitabine|"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).~Following the phase I portion, patients in phase II receive the following induction:~Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.~Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.~Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.~Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.~Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5)."
10815205|NCT01870401|BG000|Baseline|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815206|NCT01870401|BG001|Baseline|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815207|NCT01870401|BG002|Baseline|Total|Total of all reporting groups
10815208|NCT01870401|FG000|Participant Flow|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815209|NCT01870401|FG001|Participant Flow|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815210|NCT01870401|OG000|Outcome|Lutonix DCB|"Lutonix Paclitaxel Drug Coated Balloon~Lutonix DCB"
10815211|NCT01870401|OG001|Outcome|PTA Catheter|"Standard Uncoated PTA Catheter~Uncoated PTA Catheter"
10815212|NCT01870401|OG000|Outcome|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
11206340|NCT02234570|OG000|Outcome|0.5 mg/kg Oxfendazole|Participants received a single oral dose 0.5 mg/kg of oxfendazole.
10815213|NCT01870401|OG001|Outcome|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815214|NCT01870401|EG000|Reported Event|Lutonix DCB|"Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon.~Lutonix DCB~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815215|NCT01870401|EG001|Reported Event|Standard Balloon Angioplasty Catheter|"Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.~Standard Balloon Angioplasty Catheter~Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
10815216|NCT01867606|BG000|Baseline|Arm II (Placebo)|"Patients receive placebo PO BID on days 1-28.>>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>~>> placebo: Given PO>>~>> laboratory biomarker analysis: Correlative studies>>~>> quality-of-life assessment: Ancillary studies>>~>> questionnaire administration: Ancillary studies"
10815217|NCT01867606|BG001|Baseline|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|"Patients receive SBI PO BID on days 1-28.>>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>~>> serum-derived bovine immunoglobulin protein isolate: Given PO>>~>> laboratory biomarker analysis: Correlative studies>>~>> quality-of-life assessment: Ancillary studies>>~>> questionnaire administration: Ancillary studies"
10815218|NCT01867606|BG002|Baseline|Total|Total of all reporting groups
10815219|NCT01867606|FG000|Participant Flow|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|"Patients receive SBI PO BID on days 1-28.>>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>~>> serum-derived bovine immunoglobulin protein isolate: Given PO>>~>> laboratory biomarker analysis: Correlative studies>>~>> quality-of-life assessment: Ancillary studies>>~>> questionnaire administration: Ancillary studies"
10815220|NCT01867606|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO BID on days 1-28.>>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.>>~>> placebo: Given PO>>~>> laboratory biomarker analysis: Correlative studies>>~>> quality-of-life assessment: Ancillary studies>>~>> questionnaire administration: Ancillary studies"
10815221|NCT01867606|OG000|Outcome|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|"Patients receive SBI PO BID on days 1-28. >~>~>~>~>~> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~>~>~>~>~>~> serum-derived bovine immunoglobulin protein isolate: Given PO"
10815222|NCT01867606|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID on days 1-28. >~>~>~>~>~> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~>~>~>~>~>~> placebo: Given PO"
10815223|NCT01867606|OG000|Outcome|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|"Patients receive SBI PO BID on days 1-28. >>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~>>~>> serum-derived bovine immunoglobulin protein isolate: Given PO"
10815224|NCT01867606|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID on days 1-28. >>~>> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.~>>~>> placebo: Given PO"
10815225|NCT01867606|OG000|Outcome|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
10815226|NCT01867606|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
10815227|NCT01867606|OG000|Outcome|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|Patients receive SBI PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. serum-derived bovine immunoglobulin protein isolate: Given PO
10815228|NCT01867606|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.placebo: Given PO
10815229|NCT01867606|EG000|Reported Event|Arm II (Placebo)|questionnaire administration: Ancillary studies
10815230|NCT01867606|EG001|Reported Event|Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate)|questionnaire administration: Ancillary studies
10815231|NCT01857063|BG000|Baseline|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
10815232|NCT01857063|BG001|Baseline|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
10815233|NCT01857063|BG002|Baseline|Total|Total of all reporting groups
10815234|NCT01857063|FG000|Participant Flow|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
10815235|NCT01857063|FG001|Participant Flow|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
10815236|NCT01857063|OG000|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
10815237|NCT01857063|OG001|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
10815238|NCT01857063|EG000|Reported Event|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
10815239|NCT01857063|EG001|Reported Event|Placebo|Participants receive placebo for 7 days, regardless of sequence.
10815240|NCT01854268|BG000|Baseline|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.~Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation."
10815241|NCT01854268|FG000|Participant Flow|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.~Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation."
10815242|NCT01854268|OG000|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
10815243|NCT01854268|EG000|Reported Event|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times."
10815244|NCT01852812|BG000|Baseline|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
10815245|NCT01852812|BG001|Baseline|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815246|NCT01852812|BG002|Baseline|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815247|NCT01852812|BG003|Baseline|Total|Total of all reporting groups
10815248|NCT01852812|FG000|Participant Flow|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
10815249|NCT01852812|FG001|Participant Flow|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks
10815250|NCT01852812|FG002|Participant Flow|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815251|NCT01852812|OG000|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
10815252|NCT01852812|OG001|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815253|NCT01852812|OG001|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815254|NCT01852812|OG002|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815255|NCT01852812|EG000|Reported Event|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
10815256|NCT01852812|EG001|Reported Event|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
10815257|NCT01828021|BG000|Baseline|Margetuximab|"Monotherapy of Anti-HER2 monoclonal antibody~Margetuximab: Anti-HER2 monoclonal antibody"
10815258|NCT01828021|FG000|Participant Flow|Margetuximab|"Monotherapy of Anti-HER2 monoclonal antibody~Margetuximab: Anti-HER2 monoclonal antibody~Margetuximab was administered by IV infusion at a dose of 6.0 mg/kg on Days 1, 8, and 15 of each 28-day cycle or or 15 mg/kg every 3 weeks of each 21-day cycle"
10815259|NCT01828021|OG000|Outcome|Margetuximab|"Monotherapy of Anti-HER2 monoclonal antibody~Margetuximab: Anti-HER2 monoclonal antibody"
10815260|NCT01828021|EG000|Reported Event|Margetuximab|"Monotherapy of Anti-HER2 monoclonal antibody~Margetuximab: Anti-HER2 monoclonal antibody"
10815261|NCT01709318|BG000|Baseline|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
11206341|NCT02234570|OG001|Outcome|1 mg/kg Oxfendazole|Participants received a single oral dose 1 mg/kg of oxfendazole
11206342|NCT02234570|OG002|Outcome|3 mg/kg Oxfendazole|Participants received a single oral dose 3 mg/kg of oxfendazole
10815262|NCT01709318|BG001|Baseline|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815263|NCT01709318|BG002|Baseline|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815264|NCT01709318|BG003|Baseline|Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815265|NCT01709318|BG004|Baseline|Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815266|NCT01709318|BG005|Baseline|Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815267|NCT01709318|BG006|Baseline|NuvaRing®|Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815268|NCT01709318|BG007|Baseline|Total|Total of all reporting groups
10815269|NCT01709318|FG000|Participant Flow|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815270|NCT01709318|FG001|Participant Flow|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815271|NCT01709318|FG002|Participant Flow|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815272|NCT01709318|FG003|Participant Flow|Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815273|NCT01709318|FG004|Participant Flow|Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815274|NCT01709318|FG005|Participant Flow|Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815275|NCT01709318|FG006|Participant Flow|NuvaRing®|Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815276|NCT01709318|OG000|Outcome|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815277|NCT01709318|OG001|Outcome|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815278|NCT01709318|OG002|Outcome|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815279|NCT01709318|OG003|Outcome|Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815280|NCT01709318|OG004|Outcome|Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815281|NCT01709318|OG005|Outcome|Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815282|NCT01709318|OG006|Outcome|NuvaRing®|Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815283|NCT01709318|EG000|Reported Event|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815284|NCT01709318|EG001|Reported Event|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815285|NCT01709318|EG002|Reported Event|Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day|Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815286|NCT01709318|EG003|Reported Event|Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815287|NCT01709318|EG004|Reported Event|Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815288|NCT01709318|EG005|Reported Event|Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day|Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815289|NCT01709318|EG006|Reported Event|NuvaRing®|Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
10815290|NCT01698918|BG000|Baseline|Everolimus+Letrozole/Exemestane (First-line Treatment and Second-line Treatment)|Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)
10815291|NCT01698918|FG000|Participant Flow|Everolimus+Letrozole/Exemestane (First-line Treatment and Second-line Treatment)|Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)
10815292|NCT01698918|OG000|Outcome|Everolimus+Letrozole (First-line Treatment)|Participants received everolimus in combination with letrozole as first-line treatment.
10815293|NCT01698918|OG000|Outcome|Everolimus+Letrozole (First Line Treatment)|Participants received everolimus in combination with letrozole as first-line treatment
10815294|NCT01698918|OG000|Outcome|Everolimus+Exemestane (Second Line Treatment)|Participants who had disease progression in the first line setting (core phase) were treated with second line treatment (everolimus in combination with exemestane)
10815295|NCT01698918|OG000|Outcome|Everolimus+Exemestane (Second-line Treatment)|Participants who had disease progression in the first line setting (core phase) were treated with second-line treatment (everolimus in combination with exemestane)
10815296|NCT01698918|OG000|Outcome|Everolimus+Letrozole/Exemestane (First-line Treatment and Second-line Treatment)|Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)
10815297|NCT01698918|OG000|Outcome|Everolimus+ Letrozole (First-line Treatment)|Participants received everolimus in combination with letrozole as first-line treatment
10815298|NCT01698918|OG001|Outcome|Everolimus+Exemestane (Second-line Treatment)|Participants who had disease progression in the first line setting (core phase) were treated with second-line treatment (everolimus in combination with exemestane)
10815299|NCT01698918|OG000|Outcome|Everolimus + Letrozole/Exemestane (First-line and Second-line Treatment)|Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)
10815300|NCT01698918|EG000|Reported Event|Everolimus+Letrozole (First-line Treatment)|Participants received everolimus in combination with letrozole as first-line treatment.
10815301|NCT01698918|EG001|Reported Event|Everolimus+Exemestane (Second-line Treatment)|Participants who had disease progression in the first line setting (core phase) were treated with second-line treatment (everolimus in combination with exemestane)
10815302|NCT01673620|BG000|Baseline|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
10815303|NCT01673620|BG001|Baseline|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
10815304|NCT01673620|BG002|Baseline|Total|Total of all reporting groups
10815305|NCT01673620|FG000|Participant Flow|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
10815306|NCT01673620|FG001|Participant Flow|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
10815307|NCT01673620|OG000|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
10815308|NCT01673620|OG001|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
10815309|NCT01673620|EG000|Reported Event|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
10815310|NCT01673620|EG001|Reported Event|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
10815311|NCT01660243|BG000|Baseline|MT-9938 2.5μg|Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
10815312|NCT01660243|BG001|Baseline|MT-9938 5μg|Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
10815313|NCT01660243|BG002|Baseline|MT-9938 10μg|Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
10815314|NCT01660243|BG003|Baseline|Placebo|Placebo: Placebo (2capsules) once daily for 8 weeks
10815315|NCT01660243|BG004|Baseline|Total|Total of all reporting groups
10815316|NCT01660243|FG000|Participant Flow|MT-9938 2.5μg|Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
10815317|NCT01660243|FG001|Participant Flow|MT-9938 5μg|Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
10815318|NCT01660243|FG002|Participant Flow|MT-9938 10μg|Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
10815319|NCT01660243|FG003|Participant Flow|Placebo|Placebo: Placebo (2capsules) once daily for 8 weeks
10815320|NCT01660243|OG000|Outcome|MT-9938 2.5μg|Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
10815321|NCT01660243|OG001|Outcome|MT-9938 5μg|Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
10815322|NCT01660243|OG002|Outcome|MT-9938 10μg|Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
10815323|NCT01660243|OG003|Outcome|Placebo|Placebo: Placebo (2capsules) once daily for 8 weeks
10815324|NCT01660243|EG000|Reported Event|MT-9938 2.5μg|Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
10815325|NCT01660243|EG001|Reported Event|MT-9938 5μg|Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
10815326|NCT01660243|EG002|Reported Event|MT-9938 10μg|Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
10815327|NCT01660243|EG003|Reported Event|Placebo|Placebo: Placebo (2capsules) once daily for 8 weeks
10815328|NCT01617187|BG000|Baseline|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
10815329|NCT01617187|BG001|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
10815330|NCT01617187|BG002|Baseline|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
10815331|NCT01617187|BG003|Baseline|Placebo BID|Participants were administered placebo tablets BID for 42 days
10815332|NCT01617187|BG004|Baseline|Total|Total of all reporting groups
10815333|NCT01617187|FG000|Participant Flow|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
10815334|NCT01617187|FG001|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
10815335|NCT01617187|FG002|Participant Flow|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
10815336|NCT01617187|FG003|Participant Flow|Placebo BID|Participants were administered placebo tablets BID for 42 days
10815337|NCT01617187|OG000|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
10815338|NCT01617187|OG001|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
10815339|NCT01617187|OG002|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
10815340|NCT01617187|OG003|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
10815341|NCT01617187|EG000|Reported Event|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
10815342|NCT01617187|EG001|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
10815343|NCT01617187|EG002|Reported Event|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
10815344|NCT01617187|EG003|Reported Event|Placebo BID|Participants were administered placebo tablets BID for 42 days
10815345|NCT01611883|BG000|Baseline|Ezetimibe|10 mg oral dose once daily for 24 weeks
10815346|NCT01611883|BG001|Baseline|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
10815347|NCT01611883|BG002|Baseline|Total|Total of all reporting groups
10815348|NCT01611883|FG000|Participant Flow|Ezetimibe|10 mg oral dose once daily for 24 weeks
10815349|NCT01611883|FG001|Participant Flow|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
10815350|NCT01611883|OG000|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
10815351|NCT01611883|OG001|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
10815352|NCT01611883|EG000|Reported Event|Ezetimibe|10 mg oral dose once daily for 24 weeks
10815353|NCT01611883|EG001|Reported Event|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
10815354|NCT01572675|BG000|Baseline|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815355|NCT01572675|BG001|Baseline|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815356|NCT01572675|BG002|Baseline|Total|Total of all reporting groups
10815357|NCT01572675|FG000|Participant Flow|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815358|NCT01572675|FG001|Participant Flow|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815359|NCT01572675|OG000|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815360|NCT01572675|OG001|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815361|NCT01572675|OG000|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815362|NCT01572675|OG001|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815363|NCT01572675|OG002|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
11206343|NCT02234570|OG003|Outcome|7.5 mg/kg Oxfendazole|Participants received a single oral dose 7.5 mg/kg of oxfendazole
10815364|NCT01572675|OG003|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
11206344|NCT02234570|OG004|Outcome|15 mg/kg Oxfendazole|Participants received a single oral dose 15 mg/kg of oxfendazole
10815365|NCT01572675|OG004|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815366|NCT01572675|OG005|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815367|NCT01572675|OG000|Outcome|Up to Thirty Days|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days
10815368|NCT01572675|OG001|Outcome|From One to Three Months|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total
10815369|NCT01572675|OG002|Outcome|From Three Months to One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year
10815370|NCT01572675|OG003|Outcome|More Than One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
10815371|NCT01572675|OG000|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815372|NCT01572675|OG001|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815373|NCT01572675|OG002|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815374|NCT01572675|EG000|Reported Event|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815375|NCT01572675|EG001|Reported Event|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
10815376|NCT01554163|BG000|Baseline|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
10815377|NCT01554163|BG001|Baseline|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
10815378|NCT01554163|BG002|Baseline|Total|Total of all reporting groups
10815379|NCT01554163|FG000|Participant Flow|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
10815380|NCT01554163|FG001|Participant Flow|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
10815381|NCT01554163|OG000|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
10815382|NCT01554163|OG001|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
10815383|NCT01554163|EG000|Reported Event|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
10815384|NCT01554163|EG001|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
10815385|NCT01502371|BG000|Baseline|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815386|NCT01502371|BG001|Baseline|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815387|NCT01502371|BG002|Baseline|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815388|NCT01502371|BG003|Baseline|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
10815389|NCT01502371|BG004|Baseline|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815390|NCT01502371|BG005|Baseline|Total|Total of all reporting groups
10815391|NCT01502371|FG000|Participant Flow|MF MDI 50 mcg BID|Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
10815392|NCT01502371|FG001|Participant Flow|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815393|NCT01502371|FG002|Participant Flow|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815394|NCT01502371|FG003|Participant Flow|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
10815395|NCT01502371|FG004|Participant Flow|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815396|NCT01502371|OG000|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815397|NCT01502371|OG001|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815398|NCT01502371|OG002|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815399|NCT01502371|OG003|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815400|NCT01502371|OG004|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
10815401|NCT01502371|OG001|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
10815402|NCT01502371|EG000|Reported Event|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815403|NCT01502371|EG001|Reported Event|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815404|NCT01502371|EG002|Reported Event|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815405|NCT01502371|EG003|Reported Event|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
10815406|NCT01502371|EG004|Reported Event|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
10815407|NCT01490190|BG000|Baseline|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
10815408|NCT01490190|FG000|Participant Flow|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
10815409|NCT01490190|OG000|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
10815410|NCT01490190|EG000|Reported Event|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
10815411|NCT01471340|BG000|Baseline|Mometasone Furoate/Formoterol (MF/F) MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol
10815412|NCT01471340|BG001|Baseline|Mometasone Furoate (MF) MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol
10815413|NCT01471340|BG002|Baseline|Total|Total of all reporting groups
10815414|NCT01471340|FG000|Participant Flow|Mometasone Furoate/Formoterol (MF/F) MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
10815415|NCT01471340|FG001|Participant Flow|Mometasone Furoate (MF) MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
10815416|NCT01471340|OG000|Outcome|MF/F MDI BID|MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol
10815417|NCT01471340|OG001|Outcome|MF MDI BID|MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
10815418|NCT01471340|EG000|Reported Event|MF/F MDI BID|
10815419|NCT01471340|EG001|Reported Event|MF MDI BID|
10815420|NCT01462370|BG000|Baseline|All Randomized Participants|All participants randomized into the study.
10815421|NCT01462370|FG000|Participant Flow|Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg|Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
10815422|NCT01462370|FG001|Participant Flow|Ibuprofen Up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
10815423|NCT01462370|OG000|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
10815424|NCT01462370|OG001|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
10815425|NCT01462370|EG000|Reported Event|Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily|Etoricoxib 120 mg tablet given orally for one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
10815426|NCT01462370|EG001|Reported Event|Ibuprofen up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to four times a day as needed, for a maximum of 2400 mg/day in menstrual cycle 1. In menstrual cycle 2, etoricoxib was administered at a dose of 120 mg daily.
10815427|NCT01436253|BG000|Baseline|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
10815428|NCT01436253|FG000|Participant Flow|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
10815429|NCT01436253|OG000|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
10815430|NCT01436253|EG000|Reported Event|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
10815431|NCT01414192|BG000|Baseline|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815432|NCT01414192|BG001|Baseline|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815433|NCT01414192|BG002|Baseline|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
10815434|NCT01414192|BG003|Baseline|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815435|NCT01414192|BG004|Baseline|Total|Total of all reporting groups
10815436|NCT01414192|FG000|Participant Flow|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815437|NCT01414192|FG001|Participant Flow|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815438|NCT01414192|FG002|Participant Flow|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
10815439|NCT01414192|FG003|Participant Flow|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815440|NCT01414192|OG000|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815441|NCT01414192|OG001|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815442|NCT01414192|OG002|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
10815443|NCT01414192|OG003|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815444|NCT01414192|OG002|Outcome|Ezetimibe Plus Statin or Ezetimibe/Simvastatin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815445|NCT01414192|OG000|Outcome|Ezetimibe Monotherapy With or Without Prior Treatment|Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
11206345|NCT02234570|OG005|Outcome|30 mg/kg Oxfendazole|Participants received a single oral dose 30 mg/kg of oxfendazole
11206346|NCT02234570|OG006|Outcome|60 mg/kg Oxfendazole|Participants received a single oral dose 60 mg/kg of oxfendazole
11206347|NCT02234570|OG007|Outcome|Placebo|Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
11206348|NCT02234570|EG000|Reported Event|0.5 mg/kg Oxfendazole|Participants received a single oral dose 0.5 mg/kg of oxfendazole.
11206349|NCT02234570|EG001|Reported Event|1 mg/kg Oxfendazole|Participants received a single oral dose 1 mg/kg of oxfendazole
11206350|NCT02234570|EG002|Reported Event|3 mg/kg Oxfendazole|Participants received a single oral dose 3 mg/kg of oxfendazole
11206351|NCT02234570|EG003|Reported Event|7.5 mg/kg Oxfendazole|Participants received a single oral dose 7.5 mg/kg of oxfendazole
11206352|NCT02234570|EG004|Reported Event|15 mg/kg Oxfendazole|Participants received a single oral dose 15 mg/kg of oxfendazole
11206353|NCT02234570|EG005|Reported Event|30 mg/kg Oxfendazole|Participants received a single oral dose 30 mg/kg of oxfendazole
11206354|NCT02234570|EG006|Reported Event|60 mg/kg Oxfendazole|Participants received a single oral dose 60 mg/kg of oxfendazole
11206355|NCT02234570|EG007|Reported Event|Placebo|Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
11206356|NCT02234583|BG000|Baseline|DS-5565 15 mg QD Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.
11206357|NCT02234583|BG001|Baseline|DS-5565 15 mg BID Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). This group includes both rollover and De Novo BID modal.
11206358|NCT02234583|BG002|Baseline|Total|Total of all reporting groups
11206359|NCT02234583|FG000|Participant Flow|DS-5565 15 mg QD Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.
11206360|NCT02234583|FG001|Participant Flow|DS-5565 15 mg BID Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo twice daily (BID) modal.
11206361|NCT02234583|OG000|Outcome|Rollover DS-5565 15 mg QD Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.
11206362|NCT02234583|OG001|Outcome|Rollover DS-5565 15 mg BID Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.
11206363|NCT02234583|OG002|Outcome|De Novo DS-5565 15 mg QD Modal|Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.
11206364|NCT02234583|OG003|Outcome|De Novo DS-5565 15 mg BID Modal|Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.
11206365|NCT02234583|OG000|Outcome|Rollover DS-5565 15 mg QD Modal|"Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.~DS-5565: DS-5565 15 mg tablet for oral administration"
10815446|NCT01414192|OG001|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
10815447|NCT01414192|OG002|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815448|NCT01414192|EG000|Reported Event|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815449|NCT01414192|EG001|Reported Event|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
10815450|NCT01414192|EG002|Reported Event|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
10815451|NCT01414192|EG003|Reported Event|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
10815452|NCT01390415|BG000|Baseline|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815453|NCT01390415|BG001|Baseline|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815454|NCT01390415|BG002|Baseline|Total|Total of all reporting groups
10815455|NCT01390415|FG000|Participant Flow|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815456|NCT01390415|FG001|Participant Flow|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815457|NCT01390415|OG000|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815458|NCT01390415|OG001|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815459|NCT01390415|EG000|Reported Event|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815460|NCT01390415|EG001|Reported Event|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
10815461|NCT01381679|BG000|Baseline|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
10815462|NCT01381679|FG000|Participant Flow|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
10815463|NCT01381679|OG000|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
10815464|NCT01381679|EG000|Reported Event|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
10815465|NCT01370603|BG000|Baseline|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
10815466|NCT01370603|BG001|Baseline|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
10815467|NCT01370603|BG002|Baseline|Total|Total of all reporting groups
10815468|NCT01370603|FG000|Participant Flow|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
10815469|NCT01370603|FG001|Participant Flow|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
10815470|NCT01370603|OG000|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
10815471|NCT01370603|OG001|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
10815472|NCT01370603|EG000|Reported Event|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
10815473|NCT01370603|EG001|Reported Event|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks
10815474|NCT01370590|BG000|Baseline|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
10815475|NCT01370590|BG001|Baseline|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
10815476|NCT01370590|BG002|Baseline|Total|Total of all reporting groups
10815477|NCT01370590|FG000|Participant Flow|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
10815478|NCT01370590|FG001|Participant Flow|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
10815479|NCT01370590|OG000|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
10815480|NCT01370590|OG001|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
10815481|NCT01370590|EG000|Reported Event|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
10815482|NCT01370590|EG001|Reported Event|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
10815483|NCT01368185|BG000|Baseline|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
10815484|NCT01368185|FG000|Participant Flow|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
10815485|NCT01368185|OG000|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
10815486|NCT01368185|EG000|Reported Event|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
10815487|NCT01349907|BG000|Baseline|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815488|NCT01349907|BG001|Baseline|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815489|NCT01349907|BG002|Baseline|Total|Total of all reporting groups
10815490|NCT01349907|FG000|Participant Flow|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815491|NCT01349907|FG001|Participant Flow|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815492|NCT01349907|OG000|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815493|NCT01349907|OG001|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815494|NCT01349907|EG000|Reported Event|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815495|NCT01349907|EG001|Reported Event|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
10815496|NCT01345786|BG000|Baseline|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
10815497|NCT01345786|BG001|Baseline|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
10815498|NCT01345786|BG002|Baseline|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
10815499|NCT01345786|BG003|Baseline|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
10815500|NCT01345786|BG004|Baseline|Total|Total of all reporting groups
10815501|NCT01345786|FG000|Participant Flow|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
10815502|NCT01345786|FG001|Participant Flow|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
10815503|NCT01345786|FG002|Participant Flow|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
11244356|NCT02510014|OG000|Outcome|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
10815504|NCT01345786|FG003|Participant Flow|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
10815505|NCT01345786|OG000|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
10815506|NCT01345786|OG001|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
10815507|NCT01345786|OG002|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
10815508|NCT01345786|OG003|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
10815509|NCT01345786|EG000|Reported Event|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
10815510|NCT01345786|EG001|Reported Event|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
10815511|NCT01345786|EG002|Reported Event|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
10815512|NCT01345786|EG003|Reported Event|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
10815513|NCT01306929|BG000|Baseline|Pridopidine|Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
10815514|NCT01306929|FG000|Participant Flow|Pridopidine|Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
10815515|NCT01306929|OG000|Outcome|Pridopidine|Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
11206366|NCT02234583|OG001|Outcome|Rollover DS-5565 15 mg BID Modal|"Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.~DS-5565: DS-5565 15 mg tablet for oral administration"
10815516|NCT01306929|EG000|Reported Event|Pridopidine|Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
10815517|NCT01294696|BG000|Baseline|Participants With Adequate Pain Relief|Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
10815518|NCT01294696|BG001|Baseline|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
10815519|NCT01294696|BG002|Baseline|Total|Total of all reporting groups
10815520|NCT01294696|FG000|Participant Flow|All Enrolled Participants|The population consisted of all enrolled participants with adequate and inadequate pain relief.
10815521|NCT01294696|OG000|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
10815522|NCT01294696|EG000|Reported Event|Participants With Adequate Pain Relief|Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI).
10815523|NCT01294696|EG001|Reported Event|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
10815524|NCT01277822|BG000|Baseline|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
10815525|NCT01277822|BG001|Baseline|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
10815526|NCT01277822|BG002|Baseline|Total|Total of all reporting groups
11206367|NCT02234583|OG002|Outcome|De Novo DS-5565 15 mg QD Modal|"Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.~DS-5565: DS-5565 15 mg tablet for oral administration"
11206368|NCT02234583|OG003|Outcome|De Novo DS-5565 15 mg QID Modal|"Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.~DS-5565: DS-5565 15 mg tablet for oral administration"
11206369|NCT02234583|EG000|Reported Event|DS-5565 15 mg QD Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.
11206370|NCT02234583|EG001|Reported Event|DS-5565 15 mg BID Modal|Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo twice daily (BID) modal.
11206371|NCT02234596|BG000|Baseline|Nintedanib|Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
11206372|NCT02234596|FG000|Participant Flow|Nintedanib|Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
11206373|NCT02234596|OG000|Outcome|Nintedanib|Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
11206374|NCT02234596|EG000|Reported Event|Nintedanib|Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
11206375|NCT02234622|BG000|Baseline|Holistic Yoga Program|"The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.~Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention."
11206376|NCT02234622|BG001|Baseline|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics."
11206377|NCT02234622|BG002|Baseline|Total|Total of all reporting groups
11206378|NCT02234622|FG000|Participant Flow|Holistic Yoga Program|"The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.~Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention."
11206379|NCT02234622|FG001|Participant Flow|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics."
11206380|NCT02234622|OG000|Outcome|Holistic Yoga Program|"The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.~Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention."
10815527|NCT01277822|FG000|Participant Flow|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
10815528|NCT01277822|FG001|Participant Flow|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
10815529|NCT01277822|OG000|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
10815530|NCT01277822|OG001|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
10815531|NCT01277822|EG000|Reported Event|Losartan 100mg/Amlodipine 5mg|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks
10815532|NCT01277822|EG001|Reported Event|Amlodipine 10mg|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
10815533|NCT01244763|BG000|Baseline|Cohort A: Roxadustat Tiered, Weight Based Dosing TIW|Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
10815534|NCT01244763|BG001|Baseline|Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW|Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
10815535|NCT01244763|BG002|Baseline|Cohort C: Roxadustat at 50 mg TIW|Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815536|NCT01244763|BG003|Baseline|Cohort D: Roxadustat at 100 mg TIW|Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815537|NCT01244763|BG004|Baseline|Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW|Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
10815538|NCT01244763|BG005|Baseline|Cohort F: Roxadustat at 70 mg BIW Then QW|Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
10815539|NCT01244763|BG006|Baseline|Total|Total of all reporting groups
10815540|NCT01244763|FG000|Participant Flow|Cohort A: Roxadustat Tiered, Weight Based Dosing TIW|Participants received roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
10815541|NCT01244763|FG001|Participant Flow|Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW|Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.
11206381|NCT02234622|OG001|Outcome|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics."
10815542|NCT01244763|FG002|Participant Flow|Cohort C: Roxadustat at 50 mg TIW|Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815543|NCT01244763|FG003|Participant Flow|Cohort D: Roxadustat at 100 mg TIW|Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815544|NCT01244763|FG004|Participant Flow|Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW|Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.
10815545|NCT01244763|FG005|Participant Flow|Cohort F: Roxadustat at 70 mg BIW Then QW|Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
10815546|NCT01244763|OG000|Outcome|Cohort A: Roxadustat Tiered, Weight Based Dosing TIW|Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
10815547|NCT01244763|OG001|Outcome|Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW|Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
10815548|NCT01244763|OG002|Outcome|Cohort C: Roxadustat at 50 mg TIW|Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815549|NCT01244763|OG003|Outcome|Cohort D: Roxadustat at 100 mg TIW|Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815550|NCT01244763|OG004|Outcome|Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW|Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
10815551|NCT01244763|OG005|Outcome|Cohort F: Roxadustat at 70 mg BIW Then QW|Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
10815552|NCT01244763|EG000|Reported Event|Cohort A: Roxadustat Tiered, Weight Based Dosing TIW|Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
11206382|NCT02234622|OG001|Outcome|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics."
11206383|NCT02234622|OG001|Outcome|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics."
11206384|NCT02234622|EG000|Reported Event|Holistic Yoga Program|"The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.~Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention."
11206385|NCT02234622|EG001|Reported Event|Wellness Lifestyle Program|"The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.~Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics."
11244357|NCT02510014|OG001|Outcome|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
10815553|NCT01244763|EG001|Reported Event|Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW|Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
10815554|NCT01244763|EG002|Reported Event|Cohort C: Roxadustat at 50 mg TIW|Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815555|NCT01244763|EG003|Reported Event|Cohort D: Roxadustat at 100 mg TIW|Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
10815556|NCT01244763|EG004|Reported Event|Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW|Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
10815557|NCT01244763|EG005|Reported Event|Cohort F: Roxadustat at 70 mg BIW Then QW|Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
10815558|NCT01208207|BG000|Baseline|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily
10815559|NCT01208207|BG001|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg once daily
10815560|NCT01208207|BG002|Baseline|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily
10815561|NCT01208207|BG003|Baseline|Total|Total of all reporting groups
10815562|NCT01208207|FG000|Participant Flow|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
10815563|NCT01208207|FG001|Participant Flow|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
10815564|NCT01208207|FG002|Participant Flow|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
10815565|NCT01208207|FG003|Participant Flow|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
10815566|NCT01208207|FG004|Participant Flow|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
10815567|NCT01208207|FG005|Participant Flow|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
10815568|NCT01208207|FG006|Participant Flow|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
10815569|NCT01208207|OG000|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
10815570|NCT01208207|OG001|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
10815571|NCT01208207|OG000|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
10815572|NCT01208207|OG001|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
10815573|NCT01208207|OG000|Outcome|Etoricoxib 60 mg/ 90 mg|Etoricoxib 60 mg in Part I and Etoricoxib 90 mg in Part II
10815574|NCT01208207|OG001|Outcome|Etoricoxib 60 mg / 60 mg|Etoricoxib 60 mg in Part I and Etoricoxib 60 mg in Part II
10815575|NCT01208207|OG000|Outcome|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
10815576|NCT01208207|OG001|Outcome|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
10815577|NCT01208207|OG002|Outcome|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
11206386|NCT02234713|BG000|Baseline|Behavioural Intervention/Feedback|"The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.~Motivational Interview"
10815578|NCT01208207|OG003|Outcome|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
10815579|NCT01208207|OG004|Outcome|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
10815580|NCT01208207|OG005|Outcome|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
10815581|NCT01208207|OG006|Outcome|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
10815582|NCT01208207|EG000|Reported Event|Etoricoxib 60 mg / Etoricoxib 60 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
10815583|NCT01208207|EG001|Reported Event|Etoricoxib 60 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
10815584|NCT01208207|EG002|Reported Event|Etoricoxib 90 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
10815585|NCT01208207|EG003|Reported Event|Naproxen 1000 mg / Naproxen 1000 mg|Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
10815586|NCT01208207|EG004|Reported Event|Etoricoxib 60 mg|Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
10815587|NCT01208207|EG005|Reported Event|Etoricoxib 90 mg|Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
10815588|NCT01208207|EG006|Reported Event|Naproxen 1000 mg|Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
10815589|NCT01208181|BG000|Baseline|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
10815590|NCT01208181|BG001|Baseline|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
11206387|NCT02234713|BG001|Baseline|Video Attention Control|"The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.~Video Attention Control"
10815591|NCT01208181|BG002|Baseline|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
10815592|NCT01208181|BG003|Baseline|Total|Total of all reporting groups
10815593|NCT01208181|FG000|Participant Flow|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
10815594|NCT01208181|FG001|Participant Flow|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
10815595|NCT01208181|FG002|Participant Flow|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
10815596|NCT01208181|FG003|Participant Flow|Etoricoxib 60/Etoricoxib 90mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
10815597|NCT01208181|FG004|Participant Flow|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
10815598|NCT01208181|OG000|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
10815599|NCT01208181|OG001|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
10815600|NCT01208181|OG002|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
10815601|NCT01208181|OG000|Outcome|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
10815602|NCT01208181|OG001|Outcome|Etoricoxib 60 mg/Etoricoxib 90 mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and etoricoxib 90 mg tablets Part 2 of the study.
10815603|NCT01208181|OG000|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
10815604|NCT01208181|OG001|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
10815605|NCT01208181|OG002|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
10815606|NCT01208181|OG003|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
10815607|NCT01208181|OG004|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
10815608|NCT01208181|EG000|Reported Event|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
10815609|NCT01208181|EG001|Reported Event|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
10815610|NCT01208181|EG002|Reported Event|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
11206388|NCT02234713|BG002|Baseline|Total|Total of all reporting groups
11206389|NCT02234713|FG000|Participant Flow|Behavioural Intervention/Feedback|"The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.~Motivational Interview"
10815611|NCT01208181|EG003|Reported Event|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
10815612|NCT01208181|EG004|Reported Event|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
10815613|NCT01206517|BG000|Baseline|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
11206390|NCT02234713|FG001|Participant Flow|Video Attention Control|"The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.~Video Attention Control"
11206391|NCT02234713|OG000|Outcome|Baseline|
11206392|NCT02234713|OG001|Outcome|3-month Follow up|
10815614|NCT01206517|BG001|Baseline|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
10815615|NCT01206517|BG002|Baseline|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
10815616|NCT01206517|BG003|Baseline|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815617|NCT01206517|BG004|Baseline|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815618|NCT01206517|BG005|Baseline|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815619|NCT01206517|BG006|Baseline|Total|Total of all reporting groups
10815620|NCT01206517|FG000|Participant Flow|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
10815621|NCT01206517|FG001|Participant Flow|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
10815622|NCT01206517|FG002|Participant Flow|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
10815623|NCT01206517|FG003|Participant Flow|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
11206393|NCT02234713|OG002|Outcome|6-month Follow up|
11206394|NCT02234713|EG000|Reported Event|Behavioural Intervention/Feedback|"The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.~Motivational Interview"
11206395|NCT02234713|EG001|Reported Event|Video Attention Control|"The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.~Video Attention Control"
11206396|NCT02234752|BG000|Baseline|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
10815624|NCT01206517|FG004|Participant Flow|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815625|NCT01206517|FG005|Participant Flow|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815626|NCT01206517|OG000|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
10815627|NCT01206517|OG001|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
10815628|NCT01206517|OG002|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
10815629|NCT01206517|OG003|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815630|NCT01206517|OG004|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815631|NCT01206517|OG005|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
10815632|NCT01206517|EG000|Reported Event|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
10815633|NCT01206517|EG001|Reported Event|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
10815634|NCT01206517|EG002|Reported Event|Asenapine 10 mg - Cohort 3a-d|"Participants 10-17 years of age:~Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12~Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8"
10815635|NCT01190267|BG000|Baseline|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
10815636|NCT01190267|BG001|Baseline|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
10815637|NCT01190267|BG002|Baseline|Total|Total of all reporting groups
10815638|NCT01190267|FG000|Participant Flow|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
10815639|NCT01190267|FG001|Participant Flow|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
10815640|NCT01190267|OG000|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
10815641|NCT01190267|OG001|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
10815642|NCT01190267|EG000|Reported Event|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
10822005|NCT00073749|OG001|Outcome|Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2|Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10815643|NCT01190267|EG001|Reported Event|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
10815644|NCT01190254|BG000|Baseline|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
10815645|NCT01190254|BG001|Baseline|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
10815646|NCT01190254|BG002|Baseline|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
10815647|NCT01190254|BG003|Baseline|Total|Total of all reporting groups
10815648|NCT01190254|FG000|Participant Flow|Placebo|Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks
10815649|NCT01190254|FG001|Participant Flow|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
10815650|NCT01190254|FG002|Participant Flow|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
10815651|NCT01190254|OG000|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
10815652|NCT01190254|OG001|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
11206397|NCT02234752|FG000|Participant Flow|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
11206398|NCT02234752|OG000|Outcome|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
11206399|NCT02234752|OG000|Outcome|KP Metabolites Values|
11206400|NCT02234752|EG000|Reported Event|Galantamine ER, Memantine XR|"Week 1, Galantamine ER 8 mg HS & Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS & Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS & Memantine XR 21 mg HS~Galantamine ER~Memantine XR"
10815653|NCT01190254|OG002|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
10815654|NCT01190254|EG000|Reported Event|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
10815655|NCT01190254|EG001|Reported Event|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
10815656|NCT01190254|EG002|Reported Event|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
10815657|NCT01154036|BG000|Baseline|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
10815658|NCT01154036|BG001|Baseline|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
10815659|NCT01154036|BG002|Baseline|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
10815660|NCT01154036|BG003|Baseline|Total|Total of all reporting groups
10815661|NCT01154036|FG000|Participant Flow|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
10815662|NCT01154036|FG001|Participant Flow|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
10815663|NCT01154036|FG002|Participant Flow|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
10815664|NCT01154036|FG003|Participant Flow|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
10815665|NCT01154036|FG004|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815666|NCT01154036|FG005|Participant Flow|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
10815667|NCT01154036|FG006|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815668|NCT01154036|FG007|Participant Flow|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
11206401|NCT02235064|BG000|Baseline|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
11206402|NCT02235064|BG001|Baseline|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
11206403|NCT02235064|BG002|Baseline|Total|Total of all reporting groups
11206404|NCT02235064|FG000|Participant Flow|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
10815669|NCT01154036|OG000|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
10815670|NCT01154036|OG001|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
10815671|NCT01154036|OG002|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
10815672|NCT01154036|OG000|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815673|NCT01154036|OG001|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
10815674|NCT01154036|OG002|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815675|NCT01154036|OG003|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
10815676|NCT01154036|OG004|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
10815677|NCT01154036|OG002|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
10815678|NCT01154036|OG002|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
10815679|NCT01154036|EG000|Reported Event|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
10815680|NCT01154036|EG001|Reported Event|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
10815681|NCT01154036|EG002|Reported Event|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
10815682|NCT01154036|EG003|Reported Event|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
10815683|NCT01154036|EG004|Reported Event|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815684|NCT01154036|EG005|Reported Event|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
10815685|NCT01154036|EG006|Reported Event|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
10815686|NCT01154036|EG007|Reported Event|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
10815687|NCT01101464|BG000|Baseline|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
10815688|NCT01101464|BG001|Baseline|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
10815689|NCT01101464|BG002|Baseline|Total|Total of all reporting groups
10815690|NCT01101464|FG000|Participant Flow|Asenapine, (3) 5mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
10815691|NCT01101464|FG001|Participant Flow|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
10815692|NCT01101464|OG000|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
10815693|NCT01101464|OG001|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
10815694|NCT01101464|OG000|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
10815695|NCT01101464|OG001|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
10815696|NCT01101464|EG000|Reported Event|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
10815697|NCT01101464|EG001|Reported Event|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
10815698|NCT01098071|BG000|Baseline|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
10815699|NCT01098071|FG000|Participant Flow|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
10815700|NCT01098071|OG000|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
10815701|NCT01098071|EG000|Reported Event|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
10815702|NCT01077830|BG000|Baseline|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
10815703|NCT01077830|BG001|Baseline|Placebo|Participants who received placebo in the base study
10815704|NCT01077830|BG002|Baseline|Total|Total of all reporting groups
10815705|NCT01077830|FG000|Participant Flow|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
10815706|NCT01077830|FG001|Participant Flow|Placebo|Participantss who received placebo in the base study
10815707|NCT01077830|OG000|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
10815708|NCT01077830|OG001|Outcome|Placebo|Participants who received placebo in the base study
10815709|NCT01077830|EG000|Reported Event|Ezetimibe/Simvastatin 10/40 mg|Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
10815710|NCT01077830|EG001|Reported Event|Placebo|Participants who were assigned to the placebo cohort in the base study
10815711|NCT01070966|BG000|Baseline|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
10815712|NCT01070966|FG000|Participant Flow|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
10815713|NCT01070966|OG000|Outcome|Participants Treated With VYTORIN|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
10815714|NCT01070966|OG000|Outcome|Participants Baseline Lipid Parameters|Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
10815715|NCT01070966|OG001|Outcome|Participants Treatment Lipid Parameters|Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
10815716|NCT01070966|OG002|Outcome|Participants Percent Change|
10815717|NCT01070966|EG000|Reported Event|VYTORIN YEAR 1|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
10815718|NCT01070966|EG001|Reported Event|VYTORIN YEAR 2|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
10815719|NCT01070966|EG002|Reported Event|VYTORIN YEAR 4|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
10815720|NCT01070966|EG003|Reported Event|VYTORIN YEAR 5|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
10815721|NCT01070966|EG004|Reported Event|VYTORIN YEAR 6|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
10815722|NCT01070953|BG000|Baseline|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
10815723|NCT01070953|FG000|Participant Flow|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
10815724|NCT01070953|OG000|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
10815725|NCT01070953|OG000|Outcome|All Participants|
10815726|NCT01070953|EG000|Reported Event|EZETROL Year 1|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
10815727|NCT01070953|EG001|Reported Event|EZETROL Year 2|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
10815728|NCT01070953|EG002|Reported Event|EZETROL Year 3|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
10815729|NCT01070953|EG003|Reported Event|EZETROL Year 4|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
10815730|NCT01070953|EG004|Reported Event|EZETROL Year 5|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
10815731|NCT01070953|EG005|Reported Event|EZETROL Year 6|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
10815732|NCT01030341|BG000|Baseline|All Participants|"Continuous glucose monitoring in conjunction with insulin pump~CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump"
10815733|NCT01030341|FG000|Participant Flow|All Participants|"Continuous glucose monitoring in conjunction with insulin pump~CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump"
10815734|NCT01030341|OG000|Outcome|All Participants|"Continuous glucose monitoring in conjunction with insulin pump~CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump"
10815735|NCT01030341|EG000|Reported Event|All Participants|"Continuous glucose monitoring in conjunction with insulin pump~CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump"
11206405|NCT02235064|FG001|Participant Flow|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
10815736|NCT00979901|BG000|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
10815737|NCT00979901|BG001|Baseline|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815738|NCT00979901|BG002|Baseline|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815739|NCT00979901|BG003|Baseline|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
10815740|NCT00979901|BG004|Baseline|Total|Total of all reporting groups
10815741|NCT00979901|FG000|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
10815742|NCT00979901|FG001|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
11206406|NCT02235064|OG000|Outcome|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
10815743|NCT00979901|FG002|Participant Flow|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815744|NCT00979901|FG003|Participant Flow|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
10815745|NCT00979901|OG000|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
10815746|NCT00979901|OG001|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815747|NCT00979901|OG002|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815748|NCT00979901|EG000|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
10815749|NCT00979901|EG001|Reported Event|Montelukast 10mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815750|NCT00979901|EG002|Reported Event|Loratadine 10mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
10815751|NCT00979901|EG003|Reported Event|Montelukast 10 mg + Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
10815752|NCT00963599|BG000|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815753|NCT00963599|BG001|Baseline|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815754|NCT00963599|BG002|Baseline|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815755|NCT00963599|BG003|Baseline|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
10815756|NCT00963599|BG004|Baseline|Total|Total of all reporting groups
10815757|NCT00963599|FG000|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815758|NCT00963599|FG001|Participant Flow|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815759|NCT00963599|FG002|Participant Flow|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815760|NCT00963599|FG003|Participant Flow|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
10815761|NCT00963599|OG000|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815762|NCT00963599|OG001|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815763|NCT00963599|OG002|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815764|NCT00963599|OG003|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
10815765|NCT00963599|EG000|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815766|NCT00963599|EG001|Reported Event|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815767|NCT00963599|EG002|Reported Event|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
10815768|NCT00963599|EG003|Reported Event|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
10815769|NCT00954915|BG000|Baseline|Teplizumab|Anti CD-3 monoclonal antibody
10815770|NCT00954915|FG000|Participant Flow|Teplizumab|Anti CD-3 monoclonal antibody
10815771|NCT00954915|OG000|Outcome|Teplizumab|anti-CD3 monoclonal antibody
10815772|NCT00954915|OG000|Outcome|Teplizumab|Anti CD-3 monoclonal antibody
10815773|NCT00954915|EG000|Reported Event|Teplizumab|Anti CD-3 monoclonal antibody
10815774|NCT00953680|BG000|Baseline|All Participants|All randomized patients
10815775|NCT00953680|FG000|Participant Flow|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
10815776|NCT00953680|FG001|Participant Flow|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
10815777|NCT00953680|OG000|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
10815778|NCT00953680|OG001|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
10815779|NCT00953680|EG000|Reported Event|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
10815780|NCT00953680|EG001|Reported Event|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
10815781|NCT00945035|BG000|Baseline|All Participants in Study|
10815782|NCT00945035|FG000|Participant Flow|Etoricoxib FMI Then Etoricoxib URC|FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
10815783|NCT00945035|FG001|Participant Flow|Etoricoxib URC Then Etoricoxib FMI|URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
10815784|NCT00945035|OG000|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
10815785|NCT00945035|OG001|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
10815786|NCT00945035|EG000|Reported Event|Etoricoxib FMI|FMI Formulation (20%), Final Market Image
10815787|NCT00945035|EG001|Reported Event|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
10815788|NCT00943852|BG000|Baseline|All Participants in Study|
10815789|NCT00943852|FG000|Participant Flow|Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN|Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
10815790|NCT00943852|FG001|Participant Flow|Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
10815791|NCT00943852|FG002|Participant Flow|ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN|ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
10815792|NCT00943852|FG003|Participant Flow|Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo|Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo - single dose with ≥ 4 days washout between doses
10815793|NCT00943852|FG004|Participant Flow|Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan|Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
10815794|NCT00943852|FG005|Participant Flow|Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN|Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg - single dose with ≥ 4 days washout between doses
10815795|NCT00943852|FG006|Participant Flow|Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg - single dose with ≥ 4 days washout between doses
10815796|NCT00943852|FG007|Participant Flow|ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo|ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo - single dose with ≥ 4 days washout between doses
10815797|NCT00943852|FG008|Participant Flow|Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan|Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg - single dose with ≥ 4 days washout between doses
10815798|NCT00943852|FG009|Participant Flow|Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN|Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg - single dose with ≥ 4 days washout between doses
10815799|NCT00943852|OG000|Outcome|Losartan 100 mg + ISMN 60 mg|
10815800|NCT00943852|OG001|Outcome|Losartan 100 mg|
11206407|NCT02235064|OG001|Outcome|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
10815801|NCT00943852|OG001|Outcome|Placebo|
10815802|NCT00943852|EG000|Reported Event|Placebo|
10815803|NCT00943852|EG001|Reported Event|Losartan 100 mg|
10815804|NCT00943852|EG002|Reported Event|Losartan 100 mg + ISMN 15 mg|
10815805|NCT00943852|EG003|Reported Event|Losartan 100 mg + ISMN 60 mg|
10815806|NCT00943852|EG004|Reported Event|ISMN 60 mg|
10815807|NCT00927953|BG000|Baseline|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
10815808|NCT00927953|BG001|Baseline|Placebo - Normal Saline|single intravenous infusion of saline placebo
10815809|NCT00927953|BG002|Baseline|Total|Total of all reporting groups
10815810|NCT00927953|FG000|Participant Flow|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
10815811|NCT00927953|FG001|Participant Flow|Placebo - Normal Saline|single intravenous infusion of saline placebo
11206408|NCT02235064|OG000|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
11206409|NCT02235064|OG001|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
10815812|NCT00927953|OG000|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
10815813|NCT00927953|OG001|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
10815814|NCT00927953|OG001|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
10815815|NCT00927953|EG000|Reported Event|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
10815816|NCT00927953|EG001|Reported Event|Placebo - Normal Saline|single intravenous infusion of saline placebo
10815817|NCT00909389|BG000|Baseline|Filipino Patients With Hypercholesterolemia|
10815818|NCT00909389|FG000|Participant Flow|Filipino Patients With Hypercholesterolemia|
10815819|NCT00909389|OG000|Outcome|Filipino Patients With Hypercholesterolemia|
10815820|NCT00909389|EG000|Reported Event|Filipino Patients With Hypercholesterolemia|
10815821|NCT00820027|BG000|Baseline|Etoricoxib 90 mg|Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815822|NCT00820027|BG001|Baseline|Etoricoxib 120 mg|Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815823|NCT00820027|BG002|Baseline|Ibuprofen 1800 mg|Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
10815824|NCT00820027|BG003|Baseline|Placebo|Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
10815825|NCT00820027|BG004|Baseline|Total|Total of all reporting groups
10815826|NCT00820027|FG000|Participant Flow|Etoricoxib 90 mg|Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815827|NCT00820027|FG001|Participant Flow|Etoricoxib 120 mg|Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815828|NCT00820027|FG002|Participant Flow|Ibuprofen 1800 mg|Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
10815829|NCT00820027|FG003|Participant Flow|Placebo|Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
10815830|NCT00820027|OG000|Outcome|Etoricoxib 90 mg|Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815831|NCT00820027|OG001|Outcome|Etoricoxib 120 mg|Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815832|NCT00820027|OG002|Outcome|Placebo|Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
10815833|NCT00820027|OG002|Outcome|Ibuprofen 1800 mg|Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
10815834|NCT00820027|OG003|Outcome|Placebo|Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
10815835|NCT00820027|EG000|Reported Event|Placebo|Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
10815836|NCT00820027|EG001|Reported Event|Etoricoxib 90 mg|Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815837|NCT00820027|EG002|Reported Event|Etoricoxib 120 mg|Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
10815838|NCT00820027|EG003|Reported Event|Ibuprofen 1800mg|Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
10822006|NCT00073749|OG002|Outcome|Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3|Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822007|NCT00073749|OG003|Outcome|Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822008|NCT00073749|OG004|Outcome|Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5|Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822009|NCT00073749|OG005|Outcome|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10822010|NCT00073749|OG000|Outcome|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10822011|NCT00073749|EG000|Reported Event|Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1|Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822012|NCT00073749|EG001|Reported Event|Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2|Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822013|NCT00073749|EG002|Reported Event|Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3|Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822014|NCT00073749|EG003|Reported Event|Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10822015|NCT00073749|EG004|Reported Event|Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5|Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
10815839|NCT00788710|BG000|Baseline|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
10815840|NCT00788710|BG001|Baseline|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
10815841|NCT00788710|BG002|Baseline|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
10815842|NCT00788710|BG003|Baseline|Total|Total of all reporting groups
10815843|NCT00788710|FG000|Participant Flow|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
10815844|NCT00788710|FG001|Participant Flow|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
10815845|NCT00788710|FG002|Participant Flow|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
10815846|NCT00788710|OG000|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
10815847|NCT00788710|OG001|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
10815848|NCT00788710|OG002|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
10815849|NCT00788710|EG000|Reported Event|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
10815850|NCT00788710|EG001|Reported Event|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
10815851|NCT00788710|EG002|Reported Event|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
10815852|NCT00783224|BG000|Baseline|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
10815853|NCT00783224|BG001|Baseline|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
10815854|NCT00783224|BG002|Baseline|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
11206410|NCT02235064|EG000|Reported Event|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
10815855|NCT00783224|BG003|Baseline|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
10815856|NCT00783224|BG004|Baseline|Total|Total of all reporting groups
10815857|NCT00783224|FG000|Participant Flow|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
10815858|NCT00783224|FG001|Participant Flow|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
10815859|NCT00783224|FG002|Participant Flow|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
10815860|NCT00783224|FG003|Participant Flow|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
10815861|NCT00783224|OG000|Outcome|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
10815862|NCT00783224|OG001|Outcome|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
10815863|NCT00783224|OG002|Outcome|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
10815864|NCT00783224|OG003|Outcome|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
10815865|NCT00783224|EG000|Reported Event|Mometasone Furoate Placebo and Fluticasone Propionate Placebo|Both placebo groups (arms) were combined to report adverse events
10815866|NCT00783224|EG001|Reported Event|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
10815867|NCT00783224|EG002|Reported Event|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
10815868|NCT00780403|BG000|Baseline|Total Population|All randomized subjects.
10815869|NCT00780403|FG000|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
10815870|NCT00780403|FG001|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
10815871|NCT00780403|OG000|Outcome|RediTab|All randomized subjects.
10815872|NCT00780403|OG001|Outcome|Zyrtec|All randomized subjects.
10815873|NCT00780403|OG002|Outcome|No Preference|All randomized subjects.
10815874|NCT00780403|EG000|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
10815875|NCT00780403|EG001|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
10815876|NCT00779116|BG000|Baseline|Total Population|All randomized subjects
10815877|NCT00779116|FG000|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.
10815878|NCT00779116|FG001|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
10815879|NCT00779116|OG000|Outcome|RediTab|All randomized subjects.
10815880|NCT00779116|OG001|Outcome|Zyrtec|All randomized subjects.
10815881|NCT00779116|OG002|Outcome|No Preference|All randomized subjects.
10815882|NCT00779116|EG000|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
10815883|NCT00779116|EG001|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab (first and second intervention period).
10815884|NCT00778700|BG000|Baseline|Vehicle|Vehicle cream, applied topically, once daily from Day 1 to Week 12.
10815885|NCT00778700|BG001|Baseline|Ruxolitinib Phosphate 0.5% Cream|Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
10815886|NCT00778700|BG002|Baseline|Ruxolitinib Phosphate 1.0% Cream|Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
10815887|NCT00778700|BG003|Baseline|Ruxolitinib Phosphate 1.5% Cream|Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
10815888|NCT00778700|BG004|Baseline|Total|Total of all reporting groups
10815889|NCT00778700|FG000|Participant Flow|Vehicle Cream|Vehicle cream, applied topically, once daily from Day 1 to Week 12.
10815890|NCT00778700|FG001|Participant Flow|Ruxolitinib Phosphate 0.5% Cream|Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
10815891|NCT00778700|FG002|Participant Flow|Ruxolitinib Phosphate 1.0% Cream|Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
10815892|NCT00778700|FG003|Participant Flow|Ruxolitinib Phosphate 1.5% Cream|Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
10815893|NCT00778700|OG000|Outcome|Vehicle Cream|Vehicle cream, applied topically, once daily from Day 1 to Week 12.
10815894|NCT00778700|OG001|Outcome|Ruxolitinib Phosphate 0.5% Cream|Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
10815895|NCT00778700|OG002|Outcome|Ruxolitinib Phosphate 1.0% Cream|Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
10815896|NCT00778700|OG003|Outcome|Ruxolitinib Phosphate 1.5% Cream|Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
10815897|NCT00778700|OG000|Outcome|Ruxolitinib Phosphate 0.5% Cream|Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
10815898|NCT00778700|OG001|Outcome|Ruxolitinib Phosphate 1.0% Cream|Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
10815899|NCT00778700|OG002|Outcome|Ruxolitinib Phosphate 1.5% Cream|Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
10815900|NCT00778700|EG000|Reported Event|Vehicle Cream|Vehicle cream Vehicle cream, applied topically, once daily from Day 1 to Week 12.
10815901|NCT00778700|EG001|Reported Event|Ruxolitinib Phosphate 0.5% Cream|Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
10815902|NCT00778700|EG002|Reported Event|Ruxolitinib Phosphate 1.0% Cream|Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
10815903|NCT00778700|EG003|Reported Event|Ruxolitinib Phosphate 1.5% Cream|Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
10815904|NCT00778700|EG004|Reported Event|Total|Total
10815905|NCT00764478|BG000|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
10815906|NCT00764478|BG001|Baseline|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
10815907|NCT00764478|BG002|Baseline|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
10815908|NCT00764478|BG003|Baseline|Total|Total of all reporting groups
10815909|NCT00764478|FG000|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
10815910|NCT00764478|FG001|Participant Flow|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
10815911|NCT00764478|FG002|Participant Flow|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
10815912|NCT00764478|OG000|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
10815913|NCT00764478|OG001|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
10815914|NCT00764478|OG002|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
10815915|NCT00764478|EG000|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
10815916|NCT00764478|EG001|Reported Event|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
10815917|NCT00764478|EG002|Reported Event|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
10815918|NCT00761527|BG000|Baseline|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
10815919|NCT00761527|FG000|Participant Flow|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
10815920|NCT00761527|OG000|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
11206411|NCT02235064|EG001|Reported Event|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
10815921|NCT00761527|EG000|Reported Event|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
10815922|NCT00757627|BG000|Baseline|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
10815923|NCT00757627|FG000|Participant Flow|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
10815924|NCT00757627|OG000|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
10815925|NCT00757627|OG000|Outcome|Etoricoxib (Baseline)|Etoricoxib 60 mg q.d.
10815926|NCT00757627|OG000|Outcome|Etoricoxib (Week 4)|Etoricoxib 60 mg q.d.
10815927|NCT00757627|OG000|Outcome|Baseline - EQ-5D|
10815928|NCT00757627|OG000|Outcome|Week 4 - EQ-5D|
10815929|NCT00757627|OG000|Outcome|Etoricoxib 60 mg q.d.|
10815930|NCT00757627|EG000|Reported Event|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
10815931|NCT00756938|BG000|Baseline|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815932|NCT00756938|BG001|Baseline|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
10815933|NCT00756938|BG002|Baseline|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815934|NCT00756938|BG003|Baseline|Total|Total of all reporting groups
10815935|NCT00756938|FG000|Participant Flow|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815936|NCT00756938|FG001|Participant Flow|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
10815937|NCT00756938|FG002|Participant Flow|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815938|NCT00756938|FG003|Participant Flow|Losartan Potassium-Extension|Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
10815939|NCT00756938|OG000|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815940|NCT00756938|OG001|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
10815941|NCT00756938|OG002|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
10815942|NCT00756938|OG000|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
10815943|NCT00756938|OG001|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
10815944|NCT00756938|OG002|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
10815945|NCT00756938|OG003|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
10815946|NCT00756938|OG004|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
10815947|NCT00756938|EG000|Reported Event|Base Study-Losartan Potassium 0.1 mg/kg/Day|
10815948|NCT00756938|EG001|Reported Event|Base Study-Losartan Potassium 0.3 mg/kg/Day|
10815949|NCT00756938|EG002|Reported Event|Base Study-Losartan Potassium 0.7 mg/kg/Day|
10815950|NCT00756938|EG003|Reported Event|Base Study-Losartan 1.4 mg/kg/Day|
10815951|NCT00756938|EG004|Reported Event|Extension-Losartan 0.1 mg/kg/Day|
10815952|NCT00756938|EG005|Reported Event|Extension-Losartan 0.3 mg/kg/Day|
10815953|NCT00756938|EG006|Reported Event|Extension-Losartan 0.7 mg/kg/Day|
10815954|NCT00756938|EG007|Reported Event|Extension-Losartan 1.4 mg/kg/Day|
10815955|NCT00730132|BG000|Baseline|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
10815956|NCT00730132|FG000|Participant Flow|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
10815957|NCT00730132|OG000|Outcome|All Participants Analyzed|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
10815958|NCT00730132|OG000|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
10822016|NCT00073749|EG005|Reported Event|Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
10815959|NCT00730132|OG001|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
10815960|NCT00730132|OG002|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
10815961|NCT00730132|EG000|Reported Event|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
10815962|NCT00728416|BG000|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10815963|NCT00728416|BG001|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
10815964|NCT00728416|BG002|Baseline|Total|Total of all reporting groups
10815965|NCT00728416|FG000|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10815966|NCT00728416|FG001|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
10815967|NCT00728416|OG000|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10815968|NCT00728416|OG001|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
10815969|NCT00728416|EG000|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
10815970|NCT00728416|EG001|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
10815971|NCT00724477|BG000|Baseline|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
10815972|NCT00724477|FG000|Participant Flow|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
10815973|NCT00724477|OG000|Outcome|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
10815974|NCT00724477|EG000|Reported Event|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
10815975|NCT00723736|BG000|Baseline|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
10815976|NCT00723736|FG000|Participant Flow|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
10815977|NCT00723736|OG000|Outcome|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
10815978|NCT00723736|EG000|Reported Event|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
10815979|NCT00705081|BG000|Baseline|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
10815980|NCT00705081|BG001|Baseline|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
10815981|NCT00705081|BG002|Baseline|Total|Total of all reporting groups
10815982|NCT00705081|FG000|Participant Flow|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
10815983|NCT00705081|FG001|Participant Flow|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
10815984|NCT00705081|OG000|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
10815985|NCT00705081|OG001|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
10815986|NCT00705081|EG000|Reported Event|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
10815987|NCT00705081|EG001|Reported Event|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
10815988|NCT00704769|BG000|Baseline|Desloratadine|
10815989|NCT00704769|FG000|Participant Flow|Desloratadine|
10815990|NCT00704769|OG000|Outcome|Desloratadine|
10815991|NCT00704769|EG000|Reported Event|Desloratadine|
10815992|NCT00704535|BG000|Baseline|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
10815993|NCT00704535|FG000|Participant Flow|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
10815994|NCT00704535|OG000|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
10815995|NCT00704535|EG000|Reported Event|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
10815996|NCT00694369|BG000|Baseline|Placebo|Placebo orally once daily
10815997|NCT00694369|BG001|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
10815998|NCT00694369|BG002|Baseline|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
10815999|NCT00694369|BG003|Baseline|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
10816000|NCT00694369|BG004|Baseline|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
10816001|NCT00694369|BG005|Baseline|Total|Total of all reporting groups
10816002|NCT00694369|FG000|Participant Flow|Placebo|Placebo orally once daily
10816003|NCT00694369|FG001|Participant Flow|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
10816004|NCT00694369|FG002|Participant Flow|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
10816005|NCT00694369|FG003|Participant Flow|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
10816006|NCT00694369|FG004|Participant Flow|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
10816007|NCT00694369|OG000|Outcome|Placebo|Placebo orally once daily
10816008|NCT00694369|OG001|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
10816009|NCT00694369|OG002|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
10816010|NCT00694369|OG003|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
10816011|NCT00694369|OG004|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
10816012|NCT00694369|EG000|Reported Event|Placebo|Placebo orally once daily
10816013|NCT00694369|EG001|Reported Event|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
10816014|NCT00694369|EG002|Reported Event|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
10816015|NCT00694369|EG003|Reported Event|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
10816016|NCT00694369|EG004|Reported Event|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
10816017|NCT00671528|BG000|Baseline|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816018|NCT00671528|BG001|Baseline|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816019|NCT00671528|BG002|Baseline|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816020|NCT00671528|BG003|Baseline|Total|Total of all reporting groups
10816021|NCT00671528|FG000|Participant Flow|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816022|NCT00671528|FG001|Participant Flow|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816023|NCT00671528|FG002|Participant Flow|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816024|NCT00671528|OG000|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816025|NCT00671528|OG001|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816026|NCT00671528|OG002|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816027|NCT00671528|EG000|Reported Event|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816028|NCT00671528|EG001|Reported Event|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816029|NCT00671528|EG002|Reported Event|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
10816030|NCT00667823|BG000|Baseline|Macitentan 10 mg|Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.
10816031|NCT00667823|FG000|Participant Flow|Macitentan 10 mg|Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.
10816032|NCT00667823|OG000|Outcome|Macitentan 10 mg|Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.
10816033|NCT00667823|EG000|Reported Event|Macitentan 10 mg|Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.
10816034|NCT00652327|BG000|Baseline|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816035|NCT00652327|BG001|Baseline|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816036|NCT00652327|BG002|Baseline|Total|Total of all reporting groups
10816037|NCT00652327|FG000|Participant Flow|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816038|NCT00652327|FG001|Participant Flow|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816039|NCT00652327|OG000|Outcome|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816040|NCT00652327|OG001|Outcome|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816041|NCT00652327|EG000|Reported Event|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816042|NCT00652327|EG001|Reported Event|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
10816043|NCT00604500|BG000|Baseline|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
10816044|NCT00604500|FG000|Participant Flow|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
10816045|NCT00604500|OG000|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
10816046|NCT00604500|EG000|Reported Event|MF/F MDI 100/10 mcg BID|Included all participants that received 100/10 mcg BID (with and without dose counter)
10816047|NCT00568178|BG000|Baseline|Losartan|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
10816048|NCT00568178|BG001|Baseline|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
10816049|NCT00568178|BG002|Baseline|Total|Total of all reporting groups
10816050|NCT00568178|FG000|Participant Flow|Losartan Double Blind Normortensive|"Normotensive participants who were randomized to losartan.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo."
10816051|NCT00568178|FG001|Participant Flow|Placebo Double Blind Normotensive|"Normotensive participants who were randomized to losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
10816052|NCT00568178|FG002|Participant Flow|Losartan Double Blind Hypertensive|"Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
10816053|NCT00568178|FG003|Participant Flow|Amlodipine Double Blind Hypertensive|"Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
10816054|NCT00568178|FG004|Participant Flow|Losartan Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator's discretion.~Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared."
10816055|NCT00568178|FG005|Participant Flow|Enalapril Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator's discretion.~Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared."
11206412|NCT02235077|BG000|Baseline|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206413|NCT02235077|BG001|Baseline|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206414|NCT02235077|BG002|Baseline|Total|Total of all reporting groups
11206415|NCT02235077|FG000|Participant Flow|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206416|NCT02235077|FG001|Participant Flow|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
10816056|NCT00568178|OG000|Outcome|Losartan|Participants were randomized in a 1:1 ratio within each stratum: hypertensive patients (6 to 17 years of age) were randomized to either amlodipine or losartan; normotensive patients (1 to 17 years of age) were randomized to either placebo or losartan. Losartan (or placebo) therapy was administered orally, in tablet or suspension form, at an initial dose of approximately 0.7 mg/kg once daily (up to 50 or 100 mg total daily dose, weight-dependent). Participants who were randomized to losartan were assigned to a normotensive or hypertensive group, based on clinical profile.
11206417|NCT02235077|OG000|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206418|NCT02235077|OG001|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
10816057|NCT00568178|OG001|Outcome|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
10816058|NCT00568178|OG000|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
10816059|NCT00568178|OG001|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
10816060|NCT00568178|OG000|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
10816061|NCT00568178|OG001|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
10816062|NCT00568178|OG000|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
10816063|NCT00568178|OG001|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
10816064|NCT00568178|EG000|Reported Event|Losartan: Double-Blind Base Study|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
10822017|NCT00073749|EG006|Reported Event|Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort|Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
11206419|NCT02235077|EG000|Reported Event|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206420|NCT02235077|EG001|Reported Event|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
11206421|NCT02235285|BG000|Baseline|All Study Participants|Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
11206422|NCT02235285|FG000|Participant Flow|Breast Augmentation,Reoperation|The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
11206423|NCT02235285|OG000|Outcome|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
11206424|NCT02235285|EG000|Reported Event|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
11206425|NCT02235298|BG000|Baseline|Dapagliflozin and Metformin Group|"Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.~Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL"
11206426|NCT02235298|BG001|Baseline|Metformin and Placebo Group|"Participants in this group will receive Metformin and Placebo for 6 months.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL~Placebo: Placebo pill taken once daily to mimic Dapagliflozin"
10816065|NCT00568178|EG001|Reported Event|Amlodipine/Placebo: Double-Blind Base Study|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
10816066|NCT00568178|EG002|Reported Event|Losartan Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg."
10816067|NCT00568178|EG003|Reported Event|Enalapril: Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator."
10816068|NCT00545844|BG000|Baseline|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
10816069|NCT00545844|FG000|Participant Flow|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
10816070|NCT00545844|OG000|Outcome|Treatment Phase (All Patients) Week 0|
10816071|NCT00545844|OG001|Outcome|Treatment Phase (All Patients) Week 8|
10816072|NCT00545844|OG000|Outcome|Treatment Phase (All Patients) Week 8|
10816073|NCT00545844|EG000|Reported Event|All Patients|
10816074|NCT00511433|BG000|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816075|NCT00511433|BG001|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
11206427|NCT02235298|BG002|Baseline|Total|Total of all reporting groups
11206428|NCT02235298|FG000|Participant Flow|Dapagliflozin and Metformin Group|"Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.~Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL"
10816076|NCT00511433|BG002|Baseline|Total|Total of all reporting groups
11206429|NCT02235298|FG001|Participant Flow|Metformin and Placebo Group|"Participants in this group will receive Metformin and Placebo for 6 months.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL~Placebo: Placebo pill taken once daily to mimic Dapagliflozin"
10816077|NCT00511433|FG000|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816078|NCT00511433|FG001|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816079|NCT00511433|OG000|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816080|NCT00511433|OG001|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816081|NCT00511433|OG000|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816082|NCT00511433|OG001|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816083|NCT00511433|EG000|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816084|NCT00511433|EG001|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
10816085|NCT00511355|BG000|Baseline|NOMAC-E2|All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles
10816086|NCT00511355|BG001|Baseline|LNG-EE|"All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles"
10816087|NCT00511355|BG002|Baseline|Total|Total of all reporting groups
10816088|NCT00511355|FG000|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
10816089|NCT00511355|FG001|Participant Flow|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
10816090|NCT00511355|OG000|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
10816091|NCT00511355|OG001|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
10816092|NCT00511355|OG000|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816093|NCT00511355|OG001|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816094|NCT00511355|EG000|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
10816095|NCT00511355|EG001|Reported Event|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
10816096|NCT00511342|BG000|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816097|NCT00511342|BG001|Baseline|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816098|NCT00511342|BG002|Baseline|Total|Total of all reporting groups
10816099|NCT00511342|FG000|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816100|NCT00511342|FG001|Participant Flow|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816101|NCT00511342|OG000|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816102|NCT00511342|OG001|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816103|NCT00511342|EG000|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816104|NCT00511342|EG001|Reported Event|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
10816105|NCT00511199|BG000|Baseline|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
10816106|NCT00511199|BG001|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816107|NCT00511199|BG002|Baseline|Total|Total of all reporting groups
10816108|NCT00511199|FG000|Participant Flow|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
10816109|NCT00511199|FG001|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816110|NCT00511199|OG000|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
10816111|NCT00511199|OG001|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816112|NCT00511199|OG000|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816113|NCT00511199|OG001|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816114|NCT00511199|EG000|Reported Event|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
10816115|NCT00511199|EG001|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816116|NCT00491504|BG000|Baseline|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
10816117|NCT00491504|BG001|Baseline|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
10816118|NCT00491504|BG002|Baseline|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
10816119|NCT00491504|BG003|Baseline|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
10816120|NCT00491504|BG004|Baseline|Total|Total of all reporting groups
10816121|NCT00491504|FG000|Participant Flow|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
10816122|NCT00491504|FG001|Participant Flow|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
10816123|NCT00491504|FG002|Participant Flow|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
10816124|NCT00491504|FG003|Participant Flow|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
10816125|NCT00491504|OG000|Outcome|Mometasone Furoate Nasal Spray 200 mcg|All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1
10816126|NCT00491504|OG001|Outcome|Placebo|All subjects who received 2 sprays each nostril of placebo on Day 1
10816127|NCT00491504|EG000|Reported Event|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
10816128|NCT00491504|EG001|Reported Event|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
10816129|NCT00491504|EG002|Reported Event|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
10816130|NCT00491504|EG003|Reported Event|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
10816131|NCT00468312|BG000|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
10816132|NCT00468312|BG001|Baseline|Placebo|Two sprays in each nostril once daily
10816133|NCT00468312|BG002|Baseline|Total|Total of all reporting groups
10816134|NCT00468312|FG000|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
10816135|NCT00468312|FG001|Participant Flow|Placebo|Two sprays in each nostril once daily
10816136|NCT00468312|OG000|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
10816137|NCT00468312|OG001|Outcome|Placebo|Two sprays in each nostril once daily
10816138|NCT00468312|EG000|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
10816139|NCT00468312|EG001|Reported Event|Placebo|Two sprays in each nostril once daily
10816140|NCT00453063|BG000|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
10816141|NCT00453063|BG001|Baseline|Placebo|Two sprays in each nostril once daily
10816142|NCT00453063|BG002|Baseline|Total|Total of all reporting groups
10816143|NCT00453063|FG000|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
10816144|NCT00453063|FG001|Participant Flow|Placebo|Two sprays in each nostril once daily
10816145|NCT00453063|OG000|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
10816146|NCT00453063|OG001|Outcome|Placebo|Two sprays in each nostril once daily
10816147|NCT00453063|EG000|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
10816148|NCT00453063|EG001|Reported Event|Placebo|Two sprays in each nostril once daily
10816149|NCT00447603|BG000|Baseline|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
10816150|NCT00447603|FG000|Participant Flow|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
10816151|NCT00447603|FG001|Participant Flow|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
10816152|NCT00447603|FG002|Participant Flow|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
10816153|NCT00447603|OG000|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
10816154|NCT00447603|OG001|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
11206430|NCT02235298|OG000|Outcome|Dapagliflozin and Metformin Group|"Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.~Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL"
10816155|NCT00447603|OG002|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
10816156|NCT00447603|OG003|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
10816157|NCT00447603|EG000|Reported Event|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
10816158|NCT00447603|EG001|Reported Event|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
10816159|NCT00442351|BG000|Baseline|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
10816160|NCT00442351|BG001|Baseline|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
10816161|NCT00442351|BG002|Baseline|Total|Total of all reporting groups
10816162|NCT00442351|FG000|Participant Flow|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
10816163|NCT00442351|FG001|Participant Flow|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
10816164|NCT00442351|OG000|Outcome|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
10816165|NCT00442351|OG001|Outcome|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
10816166|NCT00442351|EG000|Reported Event|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
10816167|NCT00442351|EG001|Reported Event|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
10816168|NCT00423488|BG000|Baseline|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816169|NCT00423488|BG001|Baseline|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816170|NCT00423488|BG002|Baseline|Total|Total of all reporting groups
10816171|NCT00423488|FG000|Participant Flow|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816172|NCT00423488|FG001|Participant Flow|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816173|NCT00423488|OG000|Outcome|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816174|NCT00423488|OG001|Outcome|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816175|NCT00423488|EG000|Reported Event|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816176|NCT00423488|EG001|Reported Event|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
10816177|NCT00413972|BG000|Baseline|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
10816178|NCT00413972|BG001|Baseline|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
10816179|NCT00413972|BG002|Baseline|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
10816180|NCT00413972|BG003|Baseline|Placebo|
10816181|NCT00413972|BG004|Baseline|Total|Total of all reporting groups
10816182|NCT00413972|FG000|Participant Flow|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
10816183|NCT00413972|FG001|Participant Flow|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
10816184|NCT00413972|FG002|Participant Flow|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
10816185|NCT00413972|FG003|Participant Flow|Placebo|
10816186|NCT00413972|OG000|Outcome|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
10816187|NCT00413972|OG001|Outcome|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
10816188|NCT00413972|OG002|Outcome|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
10816189|NCT00413972|OG003|Outcome|Placebo|
10816190|NCT00413972|EG000|Reported Event|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
10816191|NCT00413972|EG001|Reported Event|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
10816192|NCT00413972|EG002|Reported Event|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
10816193|NCT00413972|EG003|Reported Event|Placebo|
10816194|NCT00413062|BG000|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816195|NCT00413062|BG001|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816196|NCT00413062|BG002|Baseline|Total|Total of all reporting groups
10816197|NCT00413062|FG000|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816198|NCT00413062|FG001|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816199|NCT00413062|OG000|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816200|NCT00413062|OG001|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816201|NCT00413062|OG000|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816202|NCT00413062|OG001|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
10816203|NCT00413062|EG000|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816204|NCT00413062|EG001|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
10816205|NCT00391170|BG000|Baseline|Dexamathasone Oral Rinse in Stem Cell Transplant Participants|Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816206|NCT00391170|BG001|Baseline|Placebo Oral Rinse in Stem Cell Transplant Participants|Placebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816207|NCT00391170|BG002|Baseline|Total|Total of all reporting groups
10816208|NCT00391170|FG000|Participant Flow|Dexamathasone Oral Rinse in Stem Cell Transplant Participants|Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816209|NCT00391170|FG001|Participant Flow|Placebo Oral Rinse in Stem Cell Transplant Participants|Placebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816210|NCT00391170|OG000|Outcome|Dexamethasone Oral Rinse in Stem Cell Transplant Participants|Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816211|NCT00391170|OG001|Outcome|Placebo Oral Rinse in Stem Cell Transplant Participants|Placebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816212|NCT00391170|EG000|Reported Event|Dexamethasone Oral Rinse in Stem Cell Transplant Participants|Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816213|NCT00391170|EG001|Reported Event|Placebo Oral Rinse in Stem Cell Transplant Participants|Placebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration.
10816214|NCT00359138|BG000|Baseline|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816215|NCT00359138|BG001|Baseline|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816216|NCT00359138|BG002|Baseline|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816217|NCT00359138|BG003|Baseline|Total|Total of all reporting groups
10816218|NCT00359138|FG000|Participant Flow|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816219|NCT00359138|FG001|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816220|NCT00359138|FG002|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816221|NCT00359138|OG000|Outcome|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816222|NCT00359138|OG001|Outcome|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816223|NCT00359138|OG002|Outcome|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816224|NCT00359138|EG000|Reported Event|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816225|NCT00359138|EG001|Reported Event|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816226|NCT00359138|EG002|Reported Event|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
10816227|NCT00350701|BG000|Baseline|Androgel 5g|"androgel 5g~androgel: androgel 5g"
10816228|NCT00350701|BG001|Baseline|Androgel 10g|"androgel 10g~androgel 10g: androgel 10g"
10816229|NCT00350701|BG002|Baseline|Placebo|"placebo~placebo: placebo"
10816230|NCT00350701|BG003|Baseline|Total|Total of all reporting groups
10816231|NCT00350701|FG000|Participant Flow|Androgel 5g|"androgel 5g~androgel: androgel 5g"
10816232|NCT00350701|FG001|Participant Flow|Androgel 10g|"androgel 10g~androgel 10g: androgel 10g"
10816233|NCT00350701|FG002|Participant Flow|Placebo|"placebo~placebo: placebo"
10816234|NCT00350701|OG000|Outcome|Androgel 5g|"androgel 5g~androgel: androgel 5g"
10816235|NCT00350701|OG001|Outcome|Androgel 10g|"androgel 10g~androgel 10g: androgel 10g"
10816236|NCT00350701|OG002|Outcome|Placebo|"placebo~placebo: placebo"
10816237|NCT00350701|EG000|Reported Event|Androgel 5g|"androgel 5g~androgel: androgel 5g"
10816238|NCT00350701|EG001|Reported Event|Androgel 10g|"androgel 10g~androgel 10g: androgel 10g"
10816239|NCT00350701|EG002|Reported Event|Placebo|"placebo~placebo: placebo"
10816240|NCT00319449|BG000|Baseline|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816241|NCT00319449|BG001|Baseline|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816242|NCT00319449|BG002|Baseline|Total|Total of all reporting groups
10816243|NCT00319449|FG000|Participant Flow|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816244|NCT00319449|FG001|Participant Flow|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816245|NCT00319449|OG000|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816246|NCT00319449|OG001|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816247|NCT00319449|EG000|Reported Event|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816248|NCT00319449|EG001|Reported Event|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
10816249|NCT00305344|BG000|Baseline|Cord Blood Recipient|Umbilical Cord Recipient
10816250|NCT00305344|FG000|Participant Flow|Cord Blood Recipient|Umbilical Cord Recipient
10816251|NCT00305344|OG000|Outcome|Recipients Receiving Cord Blood|Children with type 1 diabetes who underwent an autologous cord blood infusion
10816252|NCT00305344|EG000|Reported Event|Cord Blood Recipients|Children with type 1 diabetes who underwent an autologous cord blood infusion
10816253|NCT00289887|BG000|Baseline|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
10816254|NCT00289887|BG001|Baseline|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
10816255|NCT00289887|BG002|Baseline|Total|Total of all reporting groups
10816256|NCT00289887|FG000|Participant Flow|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
10816257|NCT00289887|FG001|Participant Flow|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
10816258|NCT00289887|OG000|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
10816259|NCT00289887|OG001|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
10816260|NCT00289887|EG000|Reported Event|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
10816261|NCT00289887|EG001|Reported Event|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
10816262|NCT00281320|BG000|Baseline|Asenapine 2-10 mg BID|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
10816263|NCT00281320|BG001|Baseline|Asenapine 5-10 mg BID|Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
10816264|NCT00281320|BG002|Baseline|Total|Total of all reporting groups
10816265|NCT00281320|FG000|Participant Flow|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
10816266|NCT00281320|FG001|Participant Flow|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
10816267|NCT00281320|OG000|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
10816268|NCT00281320|OG001|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
10816269|NCT00281320|OG000|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
10816270|NCT00281320|OG001|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
10816271|NCT00281320|OG000|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameters of asepanine for Day 4.
10816272|NCT00281320|OG001|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameters of asepanine for Day 8.
10816273|NCT00281320|OG000|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
10816274|NCT00281320|OG001|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
10816275|NCT00281320|EG000|Reported Event|Asenapine 2-10mg BID|
10816276|NCT00281320|EG001|Reported Event|Asenapine 5-10mg BID|
10816277|NCT00276016|BG000|Baseline|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
10816278|NCT00276016|BG001|Baseline|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
10816279|NCT00276016|BG002|Baseline|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
10816280|NCT00276016|BG003|Baseline|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
10816281|NCT00276016|BG004|Baseline|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
10816282|NCT00276016|BG005|Baseline|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
10816283|NCT00276016|BG006|Baseline|Total|Total of all reporting groups
10816284|NCT00276016|FG000|Participant Flow|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
10816285|NCT00276016|FG001|Participant Flow|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
10816286|NCT00276016|FG002|Participant Flow|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
10816287|NCT00276016|FG003|Participant Flow|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
10816288|NCT00276016|FG004|Participant Flow|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
10816289|NCT00276016|FG005|Participant Flow|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
10816290|NCT00276016|OG000|Outcome|Placebo|
10816291|NCT00276016|OG001|Outcome|Phenylephrine|
10816292|NCT00276016|OG000|Outcome|Pseudoephedrine|
10816293|NCT00276016|OG001|Outcome|Placebo|
10816294|NCT00276016|EG000|Reported Event|Phenylephrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration.
10816295|NCT00276016|EG001|Reported Event|Pseudoephedrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
10816296|NCT00276016|EG002|Reported Event|Placebo|Placebo: Placebo capsules.
10816297|NCT00265343|BG000|Baseline|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
10816298|NCT00265343|BG001|Baseline|Olanzapine|5-20 mg daily (QD) orally (PO)
10816299|NCT00265343|BG002|Baseline|Total|Total of all reporting groups
10816300|NCT00265343|FG000|Participant Flow|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
10816301|NCT00265343|FG001|Participant Flow|Olanzapine|5-20 mg daily (QD) orally (PO)
10816302|NCT00265343|OG000|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
11206431|NCT02235298|OG001|Outcome|Metformin and Placebo Group|"Participants in this group will receive Metformin and Placebo for 6 months.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL~Placebo: Placebo pill taken once daily to mimic Dapagliflozin"
11206432|NCT02235298|EG000|Reported Event|Dapagliflozin and Metformin Group|"Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.~Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL"
11206433|NCT02235298|EG001|Reported Event|Metformin and Placebo Group|"Participants in this group will receive Metformin and Placebo for 6 months.~Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL~Placebo: Placebo pill taken once daily to mimic Dapagliflozin"
10816303|NCT00265343|OG001|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
10816304|NCT00265343|EG000|Reported Event|Asenapine|
10816305|NCT00265343|EG001|Reported Event|Olanzapine|
10816306|NCT00264147|BG000|Baseline|Placebo|Treatment I: Placebo orally once daily
10816307|NCT00264147|BG001|Baseline|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
10816308|NCT00264147|BG002|Baseline|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
10816309|NCT00264147|BG003|Baseline|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
10816310|NCT00264147|BG004|Baseline|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
10816311|NCT00264147|BG005|Baseline|Total|Total of all reporting groups
10816312|NCT00264147|FG000|Participant Flow|Placebo|Treatment I: Placebo orally once daily
10816313|NCT00264147|FG001|Participant Flow|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
10816314|NCT00264147|FG002|Participant Flow|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
10816315|NCT00264147|FG003|Participant Flow|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
10816316|NCT00264147|FG004|Participant Flow|Etoricoxib 90 mg|Treatment I and II: Etoricoxib 90 mg orally once daily
10816317|NCT00264147|FG005|Participant Flow|Diclofenac 150 mg (Treatment II)|Treatment II: Diclofenac 75 mg orally twice daily
10816318|NCT00264147|OG000|Outcome|Placebo|Treatment I: Placebo orally once daily
10816319|NCT00264147|OG001|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
10816320|NCT00264147|OG002|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
10816321|NCT00264147|OG003|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
10816322|NCT00264147|OG004|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
10816323|NCT00264147|EG000|Reported Event|Placebo Treatment I Period|Treatment I: Placebo orally once daily
10816324|NCT00264147|EG001|Reported Event|Etoricoxib 10 mg Treatment I Period|Treatment I: Etoricoxib 10 mg orally once daily
10816325|NCT00264147|EG002|Reported Event|Etoricoxib 30 mg Treatment I Period|Treatment I: Etoricoxib 30 mg orally once daily
10816326|NCT00264147|EG003|Reported Event|Etoricoxib 60 mg Treatment I Period|Treatment I: Etoricoxib 60 mg orally once daily
10816327|NCT00264147|EG004|Reported Event|Etoricoxib 90 mg Treatment I Period|Treatment I: Etoricoxib 90 mg orally once daily
10816328|NCT00264147|EG005|Reported Event|Etoricoxib 90 mg Treatment II Period|Treatment II: Etoricoxib 90 mg orally once daily
10816329|NCT00264147|EG006|Reported Event|Diclofenac 150 mg Treatment II Period|Treatment II: Diclofenac 75 mg orally twice daily
10816330|NCT00202878|BG000|Baseline|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
10816331|NCT00202878|BG001|Baseline|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
10816332|NCT00202878|BG002|Baseline|Total|Total of all reporting groups
10816333|NCT00202878|FG000|Participant Flow|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
10816334|NCT00202878|FG001|Participant Flow|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
10816335|NCT00202878|OG000|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
10816336|NCT00202878|OG001|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
10816337|NCT00202878|EG000|Reported Event|Ezetimide/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
10816338|NCT00202878|EG001|Reported Event|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
11206434|NCT02235311|BG000|Baseline|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
10816339|NCT00174265|BG000|Baseline|Asenapine|5-10 mg sublingually twice daily for 26 weeks
10816340|NCT00174265|BG001|Baseline|Olanzapine|5-20 mg by mouth once daily for 26 weeks
10816341|NCT00174265|BG002|Baseline|Total|Total of all reporting groups
10816342|NCT00174265|FG000|Participant Flow|Asenapine|5-10 mg sublingually twice daily for 26 weeks
10816343|NCT00174265|FG001|Participant Flow|Olanzapine|5-20 mg by mouth once daily for 26 weeks
10816344|NCT00174265|OG000|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
10816345|NCT00174265|OG001|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
10816346|NCT00174265|EG000|Reported Event|Asenapine|5-10 mg sublingually twice daily for 26 weeks
10816347|NCT00174265|EG001|Reported Event|Olanzapine|5-20 mg by mouth once daily for 26 weeks
10816348|NCT00159783|BG000|Baseline|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
10816349|NCT00159783|BG001|Baseline|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
10816350|NCT00159783|BG002|Baseline|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
10816351|NCT00159783|BG003|Baseline|Total|Total of all reporting groups
10816352|NCT00159783|FG000|Participant Flow|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
10816353|NCT00159783|FG001|Participant Flow|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
10816354|NCT00159783|FG002|Participant Flow|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
10816355|NCT00159783|OG000|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
10816356|NCT00159783|OG001|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
10816357|NCT00159783|OG002|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
10816358|NCT00159783|OG000|Outcome|All Treatment Groups|Asenapine 5-10 mg twice daily for 40 weeks or Olanzapine 5-20 mg daily for 40 weeks
10816359|NCT00159783|EG000|Reported Event|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
10816360|NCT00159783|EG001|Reported Event|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
10816361|NCT00159783|EG002|Reported Event|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
10816373|NCT00092677|BG000|Baseline|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
10816374|NCT00092677|BG001|Baseline|Placebo|
10816375|NCT00092677|BG002|Baseline|Total|Total of all reporting groups
10816376|NCT00092677|FG000|Participant Flow|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
10816377|NCT00092677|FG001|Participant Flow|Placebo|
10816378|NCT00092677|OG000|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
10816379|NCT00092677|OG001|Outcome|Placebo|
10816380|NCT00092677|EG000|Reported Event|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
10816381|NCT00092677|EG001|Reported Event|Placebo|
10816382|NCT00090259|BG000|Baseline|Losartan 50 mg|
10816383|NCT00090259|BG001|Baseline|Losartan 150 mg|
10816384|NCT00090259|BG002|Baseline|Total|Total of all reporting groups
10816385|NCT00090259|FG000|Participant Flow|Losartan 50 mg|
10816386|NCT00090259|FG001|Participant Flow|Losartan 150 mg|
10816387|NCT00090259|OG000|Outcome|Losartan 50 mg|
10816388|NCT00090259|OG001|Outcome|Losartan 150 mg|
10816389|NCT00090259|EG000|Reported Event|Losartan 50 mg|
10816390|NCT00090259|EG001|Reported Event|Losartan 150 mg|
10816391|NCT00003298|BG000|Baseline|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
11206435|NCT02235311|BG001|Baseline|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206436|NCT02235311|BG002|Baseline|Total|Total of all reporting groups
11206437|NCT02235311|FG000|Participant Flow|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206438|NCT02235311|FG001|Participant Flow|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206439|NCT02235311|OG000|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206440|NCT02235311|OG001|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206441|NCT02235311|EG000|Reported Event|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206442|NCT02235311|EG001|Reported Event|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB~Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
11206443|NCT02235454|BG000|Baseline|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
11206444|NCT02235454|FG000|Participant Flow|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
11206445|NCT02235454|OG000|Outcome|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
11206446|NCT02235454|EG000|Reported Event|Glaucoma Arm|"Consecutive willing patients with glaucoma will undergo non-invasive OCT imaging~SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
11206447|NCT02235493|BG000|Baseline|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
10816392|NCT00003298|FG000|Participant Flow|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
10816393|NCT00003298|OG000|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
10816394|NCT00003298|EG000|Reported Event|Step 1(Neoadjuvant Therapy)|Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
10816395|NCT00003298|EG001|Reported Event|Step 2 (Adjuvant Therapy)|After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
10816396|NCT00003377|BG000|Baseline|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
10816397|NCT00003377|BG001|Baseline|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816398|NCT00003377|BG002|Baseline|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816399|NCT00003377|BG003|Baseline|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
10816400|NCT00003377|BG004|Baseline|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
10816401|NCT00003377|BG005|Baseline|Total|Total of all reporting groups
10816402|NCT00003377|FG000|Participant Flow|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
10816403|NCT00003377|FG001|Participant Flow|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816404|NCT00003377|FG002|Participant Flow|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
10816405|NCT00003377|FG003|Participant Flow|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
10816406|NCT00003377|FG004|Participant Flow|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
11206448|NCT02235493|FG000|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
11206449|NCT02235493|OG000|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
11206450|NCT02235493|EG000|Reported Event|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
11206451|NCT02235831|BG000|Baseline|Overall|DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
10816407|NCT00003377|OG000|Outcome|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
10816408|NCT00003377|OG001|Outcome|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816409|NCT00003377|OG002|Outcome|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
10816410|NCT00003377|OG003|Outcome|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
10816411|NCT00003377|OG004|Outcome|Arm 2, PII|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816412|NCT00003377|OG000|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816413|NCT00003377|EG000|Reported Event|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
10816414|NCT00003377|EG001|Reported Event|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816415|NCT00003377|EG002|Reported Event|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
10816416|NCT00003377|EG003|Reported Event|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
10816417|NCT00003377|EG004|Reported Event|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
10816418|NCT00003389|BG000|Baseline|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816419|NCT00003389|BG001|Baseline|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816420|NCT00003389|BG002|Baseline|Total|Total of all reporting groups
10816421|NCT00003389|FG000|Participant Flow|Arm A (ABVD)|"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Dacarbazine: given IV~Radiotherapy"
10816422|NCT00003389|FG001|Participant Flow|Arm B (Stanford V)|"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Vincristine: given IV~Mechlorethamine: given IV~Etoposide: given IV~Prednisone: taken orally~Cyclophosphamide: given IV~Radiotherapy"
10816423|NCT00003389|OG000|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816424|NCT00003389|OG001|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816425|NCT00003389|EG000|Reported Event|Arm A (ABVD)|Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816426|NCT00003389|EG001|Reported Event|Arm B (Stanford V)|Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
10816427|NCT00003404|BG000|Baseline|Adjuvant Radiotherapy|Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
10967076|NCT00891176|OG000|Outcome|Synflorix-Meningitec Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
10967077|NCT00891176|OG001|Outcome|Synflorix-NeisVac-C Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
10967078|NCT00891176|OG002|Outcome|Synflorix-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
10967079|NCT00891176|OG003|Outcome|Prevenar-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
10967080|NCT00891176|OG002|Outcome|Synflorix-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
10967081|NCT00891176|EG000|Reported Event|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967082|NCT00891176|EG001|Reported Event|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
10967083|NCT00891176|EG002|Reported Event|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10967084|NCT00891176|EG003|Reported Event|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
10967085|NCT00891202|BG000|Baseline|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
10967086|NCT00891202|BG001|Baseline|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
10967087|NCT00891202|BG002|Baseline|Total|Total of all reporting groups
10967088|NCT00891202|FG000|Participant Flow|PAP: Eliglustat|Eliglustat tartrate capsule as a single 50 milligram (mg) dose on Day 1 followed by eliglustat tartrate 50 mg capsule twice daily (BID) from Day 2 to Week 4, and then either eliglustat tartrate 50 mg capsule BID (in participants who had a Genz-99067 [active moiety of eliglustat tartrate in plasma] trough plasma concentration greater than or equal to [>=] 5 nanogram per milliliter [ng/mL]) or eliglustat tartrate 100 mg capsule BID (in participants who had a Genz-99067 trough plasma concentration less than [<] 5 ng/mL), up to Week 39. The pharmacokinetic (PK) assessment at Week 2 was used for dose adjustment after Week 4.
10967089|NCT00891202|FG001|Participant Flow|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
10967090|NCT00891202|FG002|Participant Flow|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967091|NCT00891202|FG003|Participant Flow|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967092|NCT00891202|OG000|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
10967093|NCT00891202|OG001|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
10967094|NCT00891202|OG000|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967095|NCT00891202|OG001|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967096|NCT00891202|EG000|Reported Event|Eliglustat|PAP: Eliglustat tartrate capsule 50 mg orally on Day 1 followed by eliglustat tartrate 50 mg capsule BID from Day 2 to Week 4, then either eliglustat tartrate 50 mg capsule BID(participants with Genz-99067 trough plasma concentration>=5 ng/mL) or eliglustat tartrate 100 mg capsule BID(participants with Genz-99067 trough plasma concentration<5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP & received eliglustat tartrate capsule 50 mg BID orally from Day 1(post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 & Week 47 were based on Genz-99067 trough plasma concentrations(if trough plasma concentration<5 ng/mL: next higher dose administered;if>=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967097|NCT00891202|EG001|Reported Event|Placebo|PAP: Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39. LTTP: Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline for LTTP. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
10967098|NCT00891228|BG000|Baseline|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
11206452|NCT02235831|FG000|Participant Flow|Seq I|DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
11206453|NCT02235831|FG001|Participant Flow|Seq 2|DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
10816428|NCT00003404|FG000|Participant Flow|Adjuvant Radiotherapy|Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
11206454|NCT02235831|FG002|Participant Flow|Seq 3|DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
11206455|NCT02235831|FG003|Participant Flow|Seq 4|DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
11206456|NCT02235831|FG004|Participant Flow|Seq 5|DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
11206457|NCT02235831|FG005|Participant Flow|Seq 6|DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
11206458|NCT02235831|OG000|Outcome|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
10967099|NCT00891228|BG001|Baseline|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
10967100|NCT00891228|BG002|Baseline|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
10967101|NCT00891228|BG003|Baseline|Total|Total of all reporting groups
10967102|NCT00891228|FG000|Participant Flow|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
10967103|NCT00891228|FG001|Participant Flow|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
10967104|NCT00891228|FG002|Participant Flow|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
10967105|NCT00891228|OG000|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
10967106|NCT00891228|OG001|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
10970617|NCT00911300|BG000|Baseline|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
10816429|NCT00003404|OG000|Outcome|Adjuvant Radiotherapy|"Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.~Adjuvant Radiotherapy: Adjuvant radiation therapy"
10816430|NCT00003404|OG000|Outcome|Adjuvant Radiotherapy|Adjuvant radiation after local excision or breast re-excision.
10816431|NCT00003404|EG000|Reported Event|Adjuvant Radiotherapy|Adjuvant radiation after local excision or breast re-excision.
10967107|NCT00891228|OG002|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
10967108|NCT00891228|EG000|Reported Event|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
10967109|NCT00891228|EG001|Reported Event|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
10967110|NCT00891228|EG002|Reported Event|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
10967111|NCT00891293|BG000|Baseline|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
10967112|NCT00891293|FG000|Participant Flow|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
11206459|NCT02235831|OG001|Outcome|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
10967113|NCT00891293|OG000|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
10967114|NCT00891293|EG000|Reported Event|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
10967115|NCT00891319|BG000|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
10967116|NCT00891319|BG001|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home."
10967117|NCT00891319|BG002|Baseline|Total|Total of all reporting groups
11092523|NCT01540474|BG001|Baseline|Group 2: 10 ug FMP012 With 5 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092524|NCT01540474|BG002|Baseline|Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092525|NCT01540474|BG003|Baseline|Control Group|Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
11092526|NCT01540474|BG004|Baseline|Total|Total of all reporting groups
11092527|NCT01540474|FG000|Participant Flow|Group 1: 10 ug FMP012 With 2 ug GLA-SE|"Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant"
11206460|NCT02235831|EG000|Reported Event|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
11206461|NCT02235831|EG001|Reported Event|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
11206462|NCT02235831|EG002|Reported Event|DACP MF (Low Add)|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
11206463|NCT02235870|BG000|Baseline|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
11206464|NCT02235870|BG001|Baseline|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
10816432|NCT00003453|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816433|NCT00003453|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816434|NCT00003453|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816435|NCT00003453|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816436|NCT00003456|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816437|NCT00003456|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816438|NCT00003456|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816439|NCT00003456|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816440|NCT00003457|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816441|NCT00003457|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816442|NCT00003457|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11206465|NCT02235870|BG002|Baseline|Total|Total of all reporting groups
11206466|NCT02235870|FG000|Participant Flow|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
11206467|NCT02235870|FG001|Participant Flow|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
10816443|NCT00003457|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816444|NCT00003459|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
10816445|NCT00003459|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
10816446|NCT00003459|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
10816447|NCT00003459|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
10816448|NCT00003460|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816449|NCT00003460|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816450|NCT00003460|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816451|NCT00003460|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816452|NCT00003468|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816453|NCT00003468|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816454|NCT00003468|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816455|NCT00003468|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816456|NCT00003469|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816457|NCT00003469|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
11206468|NCT02235870|OG000|Outcome|Obalon Treatment Group|Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
11206469|NCT02235870|OG001|Outcome|Sham Control Group|Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
11206470|NCT02235870|OG000|Outcome|Obalon Treatment Group|Subjects who received the Obalon Balloons.
11206471|NCT02235870|EG000|Reported Event|Treated Subjects|Treated subjects include the 198 subjects in Phase I of the study who received at least 1 Obalon Balloon and the 138 subjects in Phase II who crossover and received at least 1 Obalon Balloon
10816458|NCT00003469|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816459|NCT00003469|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816460|NCT00003470|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816461|NCT00003470|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816462|NCT00003470|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816463|NCT00003470|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816464|NCT00003471|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816465|NCT00003471|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816466|NCT00003471|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816467|NCT00003471|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816468|NCT00003472|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816469|NCT00003472|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
11206472|NCT02235870|EG001|Reported Event|Control Subjects|Control subjects include the 189 subjects in Phase I of the study who received at least 1 Sham Device and the 170 subjects in Phase II who were followed after balloon removal
11206473|NCT02235987|BG000|Baseline|Cross-over|Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
11206474|NCT02235987|FG000|Participant Flow|Octreotide, Then Ascending DG3173|Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
11206475|NCT02235987|OG000|Outcome|Baseline (Untreated Control)|
11206476|NCT02235987|OG001|Outcome|300 µg Octreotide|
11206477|NCT02235987|OG002|Outcome|100 µg DG3173|
11206478|NCT02235987|OG003|Outcome|300 µg DG3173|
11206479|NCT02235987|OG004|Outcome|900 µg DG3173|
10816470|NCT00003472|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816471|NCT00003472|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816472|NCT00003473|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816473|NCT00003473|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816474|NCT00003473|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816475|NCT00003473|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816476|NCT00003474|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816477|NCT00003474|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816478|NCT00003474|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816479|NCT00003474|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
11206480|NCT02235987|OG005|Outcome|1800 µg DG3173|
11206481|NCT02235987|EG000|Reported Event|300 µg Octreotide|
11206482|NCT02235987|EG001|Reported Event|100 µg DG3173|
11206483|NCT02235987|EG002|Reported Event|300 µg DG3173|
11206484|NCT02235987|EG003|Reported Event|900 µg DG3173|
11206485|NCT02235987|EG004|Reported Event|1800 µg DG3173|
11206486|NCT02236130|BG000|Baseline|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206487|NCT02236130|BG001|Baseline|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206488|NCT02236130|BG002|Baseline|Total|Total of all reporting groups
11206489|NCT02236130|FG000|Participant Flow|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
10967118|NCT00891319|FG000|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
10967119|NCT00891319|FG001|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home."
10967120|NCT00891319|OG000|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
10967121|NCT00891319|OG001|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
10967122|NCT00891319|EG000|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
10967123|NCT00891319|EG001|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
11206490|NCT02236130|FG001|Participant Flow|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206491|NCT02236130|OG000|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206492|NCT02236130|OG001|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206493|NCT02236130|EG000|Reported Event|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
10967124|NCT00891371|BG000|Baseline|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
10967125|NCT00891371|FG000|Participant Flow|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
10967126|NCT00891371|OG000|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
10967127|NCT00891371|EG000|Reported Event|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
10967128|NCT00891436|BG000|Baseline|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
10967129|NCT00891436|BG001|Baseline|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
10967130|NCT00891436|BG002|Baseline|Total|Total of all reporting groups
10967131|NCT00891436|FG000|Participant Flow|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
10967132|NCT00891436|FG001|Participant Flow|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
10967133|NCT00891436|OG000|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
10967134|NCT00891436|OG001|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
10967135|NCT00891436|EG000|Reported Event|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
10967136|NCT00891436|EG001|Reported Event|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
10967137|NCT00891462|BG000|Baseline|Placebo|Inhaled placebo for 12 weeks
10967138|NCT00891462|BG001|Baseline|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
10967139|NCT00891462|BG002|Baseline|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
10967140|NCT00891462|BG003|Baseline|Total|Total of all reporting groups
10967141|NCT00891462|FG000|Participant Flow|Placebo|Inhaled placebo for 12 weeks
10967142|NCT00891462|FG001|Participant Flow|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
10967143|NCT00891462|FG002|Participant Flow|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
10967144|NCT00891462|OG000|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment
10967145|NCT00891462|OG001|Outcome|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
10967146|NCT00891462|OG002|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
10967147|NCT00891462|OG000|Outcome|Placebo|Dose matched placebo twice per day, inhaled for 12 weeks of treatment
10967148|NCT00891462|OG001|Outcome|Aclidinium Bromide, 200 µg|Aclidinium bromide, 200 µg dose, Oral inhalation, twice per day, for 12 weeks of treatment
10967149|NCT00891462|EG000|Reported Event|Placebo|Inhaled placebo for 12 weeks
10967150|NCT00891462|EG001|Reported Event|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
10967151|NCT00891462|EG002|Reported Event|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
10967152|NCT00891527|BG000|Baseline|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
10967153|NCT00891527|FG000|Participant Flow|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
10967154|NCT00891527|OG000|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
10967155|NCT00891527|OG000|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
10967156|NCT00891527|EG000|Reported Event|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
10967157|NCT00891618|BG000|Baseline|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
10967158|NCT00891618|FG000|Participant Flow|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
10967159|NCT00891618|OG000|Outcome|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
10967160|NCT00891618|EG000|Reported Event|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
10967161|NCT00891657|BG000|Baseline|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
10967162|NCT00891657|BG001|Baseline|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
10967163|NCT00891657|BG002|Baseline|Total|Total of all reporting groups
10967164|NCT00891657|FG000|Participant Flow|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
10967165|NCT00891657|FG001|Participant Flow|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
10967166|NCT00891657|OG000|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
10967167|NCT00891657|OG001|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
10967168|NCT00891657|EG000|Reported Event|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
10967169|NCT00891657|EG001|Reported Event|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
10967170|NCT00891735|BG000|Baseline|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
10967171|NCT00891735|BG001|Baseline|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
10967172|NCT00891735|BG002|Baseline|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
10816480|NCT00003475|BG000|Baseline|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10967173|NCT00891735|BG003|Baseline|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
10967174|NCT00891735|BG004|Baseline|Total|Total of all reporting groups
10967175|NCT00891735|FG000|Participant Flow|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
11206494|NCT02236130|EG001|Reported Event|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
11206495|NCT02236338|BG000|Baseline|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
11206496|NCT02236338|BG001|Baseline|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
11206497|NCT02236338|BG002|Baseline|Total|Total of all reporting groups
11206498|NCT02236338|FG000|Participant Flow|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
11206499|NCT02236338|FG001|Participant Flow|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
11206500|NCT02236338|OG000|Outcome|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
10967176|NCT00891735|FG001|Participant Flow|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
11215463|NCT02299375|EG000|Reported Event|Placebo|Participants with COPD received placebo orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of inhaled corticosteroid (ICS). Salbutamol metered dose inhaler (MDI) was provided as a rescue medication.
10967177|NCT00891735|FG002|Participant Flow|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
10967178|NCT00891735|FG003|Participant Flow|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
10967179|NCT00891735|OG000|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
10967180|NCT00891735|OG001|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
10967181|NCT00891735|OG002|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
10967182|NCT00891735|OG003|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
10967183|NCT00891735|EG000|Reported Event|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
10816481|NCT00003475|FG000|Participant Flow|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816482|NCT00003475|OG000|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816483|NCT00003475|OG000|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816484|NCT00003475|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816485|NCT00003476|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816486|NCT00003476|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816487|NCT00003476|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816488|NCT00003476|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816489|NCT00003477|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816490|NCT00003477|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816491|NCT00003477|OG000|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
10816492|NCT00003477|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a visual pathway glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
10816493|NCT00003483|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816494|NCT00003483|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816495|NCT00003483|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816496|NCT00003483|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10967184|NCT00891735|EG001|Reported Event|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
10967185|NCT00891735|EG002|Reported Event|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
10967186|NCT00891735|EG003|Reported Event|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
10967187|NCT00891774|BG000|Baseline|Device|Treatment with EVOLENCE®
10967188|NCT00891774|FG000|Participant Flow|Device|Treatment with EVOLENCE®
10967189|NCT00891774|OG000|Outcome|Device|Treatment with EVOLENCE®
10967190|NCT00891774|EG000|Reported Event|Device|Treatment with EVOLENCE®
10967191|NCT00891813|BG000|Baseline|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
10967192|NCT00891813|FG000|Participant Flow|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
10967193|NCT00891813|OG000|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
10967194|NCT00891813|EG000|Reported Event|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
10967195|NCT00891839|BG000|Baseline|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
10967196|NCT00891839|FG000|Participant Flow|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
10967197|NCT00891839|OG000|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
10967198|NCT00891839|EG000|Reported Event|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
10967199|NCT00891878|BG000|Baseline|Arm A (Capecitabine)|Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
10967200|NCT00891878|BG001|Baseline|Arm B (Capecitabine+Sunitinib)|Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
10967201|NCT00891878|BG002|Baseline|Total|Total of all reporting groups
10967202|NCT00891878|FG000|Participant Flow|Arm A (Capecitabine)|Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
10967203|NCT00891878|FG001|Participant Flow|Arm B (Capecitabine+Sunitinib)|Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
10967204|NCT00891878|OG000|Outcome|Arm A (Capecitabine)|Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
10967205|NCT00891878|OG001|Outcome|Arm B (Capecitabine+Sunitinib Malate)|Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
10967206|NCT00891878|EG000|Reported Event|Arm A (Capecitabine)|Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
10967207|NCT00891878|EG001|Reported Event|Arm B (Capecitabine+Sunitinib Malate)|Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
10967208|NCT00891930|BG000|Baseline|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967209|NCT00891930|FG000|Participant Flow|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967210|NCT00891930|OG000|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
10967211|NCT00891930|OG000|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967212|NCT00891930|OG001|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967213|NCT00891930|OG000|Outcome|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967214|NCT00891930|EG000|Reported Event|Part-1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
10967215|NCT00891930|EG001|Reported Event|Part-2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
10967216|NCT00891982|BG000|Baseline|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
10967217|NCT00891982|BG001|Baseline|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
10967218|NCT00891982|BG002|Baseline|Total|Total of all reporting groups
10967219|NCT00891982|FG000|Participant Flow|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
10967220|NCT00891982|FG001|Participant Flow|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
10967221|NCT00891982|OG000|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
10967222|NCT00891982|OG001|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
10967223|NCT00891982|EG000|Reported Event|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
10967224|NCT00891982|EG001|Reported Event|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
10967225|NCT00891995|BG000|Baseline|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
10967226|NCT00891995|BG001|Baseline|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
10967227|NCT00891995|BG002|Baseline|Total|Total of all reporting groups
10967228|NCT00891995|FG000|Participant Flow|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
10967229|NCT00891995|FG001|Participant Flow|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
10967230|NCT00891995|OG000|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
10967231|NCT00891995|OG001|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
10967232|NCT00891995|EG000|Reported Event|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
10967233|NCT00891995|EG001|Reported Event|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
10967234|NCT00892008|BG000|Baseline|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
10967235|NCT00892008|FG000|Participant Flow|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
11206501|NCT02236338|OG001|Outcome|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
10967236|NCT00892008|OG000|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
10967237|NCT00892008|EG000|Reported Event|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
11244358|NCT02510014|EG000|Reported Event|De Novo Subjects|Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
10967238|NCT00892047|BG000|Baseline|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
10967239|NCT00892047|BG001|Baseline|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
10967240|NCT00892047|BG002|Baseline|Total|Total of all reporting groups
10816497|NCT00003487|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816498|NCT00003487|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816499|NCT00003487|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816500|NCT00003487|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816501|NCT00003492|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816502|NCT00003492|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816503|NCT00003492|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816504|NCT00003492|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816505|NCT00003498|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816506|NCT00003498|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816507|NCT00003498|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816508|NCT00003498|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816509|NCT00003499|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816510|NCT00003499|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816511|NCT00003499|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816512|NCT00003499|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816513|NCT00003508|BG000|Baseline|Arm: Experimental: Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816514|NCT00003508|FG000|Participant Flow|Arm: Experimental: Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816515|NCT00003508|OG000|Outcome|Arm: Experimental: Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816516|NCT00003508|EG000|Reported Event|Arm: Experimental: Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816517|NCT00003509|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816518|NCT00003509|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816519|NCT00003509|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10847659|NCT00284557|EG001|Reported Event|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
10847660|NCT00284739|BG000|Baseline|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
10847661|NCT00284739|BG001|Baseline|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
10847662|NCT00284739|BG002|Baseline|Total|Total of all reporting groups
10847663|NCT00284739|FG000|Participant Flow|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
10847664|NCT00284739|FG001|Participant Flow|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
10847665|NCT00284739|OG000|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
10847666|NCT00284739|OG001|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
10847667|NCT00284739|EG000|Reported Event|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
10847668|NCT00284739|EG001|Reported Event|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
10847669|NCT00284934|BG000|Baseline|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847670|NCT00284934|BG001|Baseline|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847671|NCT00284934|BG002|Baseline|Total|Total of all reporting groups
10847672|NCT00284934|FG000|Participant Flow|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847673|NCT00284934|FG001|Participant Flow|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847674|NCT00284934|OG000|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847675|NCT00284934|OG001|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847676|NCT00284934|EG000|Reported Event|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847677|NCT00284934|EG001|Reported Event|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
10847678|NCT00285012|BG000|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847679|NCT00285012|BG001|Baseline|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847680|NCT00285012|BG002|Baseline|Total|Total of all reporting groups
10847681|NCT00285012|FG000|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847682|NCT00285012|FG001|Participant Flow|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10816520|NCT00003509|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816521|NCT00003511|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816522|NCT00003511|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816523|NCT00003511|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816524|NCT00003511|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816525|NCT00003526|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816526|NCT00003526|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816527|NCT00003526|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816528|NCT00003526|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816529|NCT00003531|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816530|NCT00003531|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816531|NCT00003531|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10967241|NCT00892047|FG000|Participant Flow|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
10967242|NCT00892047|FG001|Participant Flow|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
10967243|NCT00892047|OG000|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
10967244|NCT00892047|OG001|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
10967245|NCT00892047|OG000|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
10967246|NCT00892047|OG001|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
10967247|NCT00892047|EG000|Reported Event|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
10967248|NCT00892047|EG001|Reported Event|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
10967249|NCT00892099|BG000|Baseline|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
10967250|NCT00892099|BG001|Baseline|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
10967251|NCT00892099|BG002|Baseline|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
10967252|NCT00892099|BG003|Baseline|Total|Total of all reporting groups
10967253|NCT00892099|FG000|Participant Flow|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
10967254|NCT00892099|FG001|Participant Flow|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
10967255|NCT00892099|FG002|Participant Flow|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
10967256|NCT00892099|OG000|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
10967257|NCT00892099|OG001|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
10967258|NCT00892099|OG002|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
10967259|NCT00892099|EG000|Reported Event|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
10967260|NCT00892099|EG001|Reported Event|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
10847683|NCT00285012|OG000|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847684|NCT00285012|OG001|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847685|NCT00285012|EG000|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10847686|NCT00285012|EG001|Reported Event|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
10967261|NCT00892099|EG002|Reported Event|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
10967262|NCT00892151|BG000|Baseline|Intended Users of the Software|Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
10967263|NCT00892151|FG000|Participant Flow|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
10967264|NCT00892151|OG000|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
10967265|NCT00892151|EG000|Reported Event|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
10967266|NCT00892177|BG000|Baseline|Phase I|Patients receive (either: 5 or 10 mg/kg) bevacizumab IV over 90 minutes on Day 1 and oral dasatinib (either: 50, 70, or 100 mg) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967267|NCT00892177|BG001|Baseline|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967268|NCT00892177|BG002|Baseline|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967269|NCT00892177|BG003|Baseline|Total|Total of all reporting groups
10816532|NCT00003531|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
10816533|NCT00003535|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816534|NCT00003535|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816535|NCT00003535|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816536|NCT00003535|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816537|NCT00003537|BG000|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816538|NCT00003537|FG000|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816539|NCT00003537|OG000|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816540|NCT00003537|EG000|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
10816541|NCT00003590|BG000|Baseline|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
10816542|NCT00003590|FG000|Participant Flow|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
10816543|NCT00003590|OG000|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
10816544|NCT00003590|EG000|Reported Event|Hydroxyurea|Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
10816545|NCT00003631|BG000|Baseline|Group A - Favorable Prognostic Group|
10816546|NCT00003631|BG001|Baseline|Group B - Intermediate Prognostic Group|
10816547|NCT00003631|BG002|Baseline|Group C - Unfavorable Prognostic Group|
10816548|NCT00003631|BG003|Baseline|Total|Total of all reporting groups
10816549|NCT00003631|FG000|Participant Flow|Group A - Favorable Prognostic Group|
10816550|NCT00003631|FG001|Participant Flow|Group B - Intermediate Prognostic Group|
10816551|NCT00003631|FG002|Participant Flow|Group C - Unfavorable Prognostic Group|
10816552|NCT00003631|OG000|Outcome|Group A - Favorable Prognostic Group|
10816553|NCT00003631|OG001|Outcome|Group B - Intermediate Prognostic Group|
10816554|NCT00003631|OG002|Outcome|Group C - Unfavorable Prognostic Group|
10816555|NCT00003631|EG000|Reported Event|Group A - Favorable Prognostic Group|
10816556|NCT00003631|EG001|Reported Event|Group B - Intermediate Prognostic Group|
10816557|NCT00003631|EG002|Reported Event|Group C - Unfavorable Prognostic Group|
10816558|NCT00003644|BG000|Baseline|Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
10816559|NCT00003644|BG001|Baseline|Paclitaxel + Carboplatin Followed by Observation|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
10816560|NCT00003644|BG002|Baseline|Total|Total of all reporting groups
10816561|NCT00003644|FG000|Participant Flow|Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
10816562|NCT00003644|FG001|Participant Flow|Paclitaxel + Carboplatin Followed by Observation|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
10816563|NCT00003644|OG000|Outcome|Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
11206502|NCT02236338|EG000|Reported Event|Radiofrequency Ablation|"Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~ClosureFAST radiofrequency catheter"
11215464|NCT02299375|EG001|Reported Event|Losmapimod 15mg|Participants with COPD received losmapimod 15 mg tablets orally, twice daily, approximately 12 hours apart and within 30 minutes after meals with a full glass of water for the duration of the treatment period in addition to standard of care, stratified according to whether a center collects sputum or not and current use of ICS. Salbutamol MDI was provided as a rescue medication.
10816564|NCT00003644|OG001|Outcome|Paclitaxel + Carboplatin Followed by Observation|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
10816565|NCT00003644|OG000|Outcome|Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 24 Cycles|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
10816566|NCT00003644|OG001|Outcome|Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 3 Cycles|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
10816567|NCT00003644|EG000|Reported Event|Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
10816568|NCT00003644|EG001|Reported Event|Paclitaxel + Carboplatin Followed by Observation|Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
10816569|NCT00003645|BG000|Baseline|Arm A|Goserelin + Bicalutamide (one year)
10816570|NCT00003645|BG001|Baseline|Arm B|No initial treatment
10816571|NCT00003645|BG002|Baseline|Total|Total of all reporting groups
10816572|NCT00003645|FG000|Participant Flow|Arm A|Goserelin + Bicalutamide (one year)
10816573|NCT00003645|FG001|Participant Flow|Arm B|No initial treatment
10816574|NCT00003645|OG000|Outcome|Arm I - Leuprolide + Flutamide|"Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.~Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months~Leuprolide Acetate: 50 mg tablet orally daily for 12 months"
10816575|NCT00003645|OG001|Outcome|Arm II - No Treatment|Arm II: Patients receive no initial treatment.
10816576|NCT00003645|OG000|Outcome|Arm A|Goserelin + Bicalutamide (one year)
10816577|NCT00003645|OG001|Outcome|Arm B|No initial treatment
10816578|NCT00003645|EG000|Reported Event|Arm I - Leuprolide + Flutamide|"Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.~Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months~Leuprolide Acetate: 50 mg tablet orally daily for 12 months"
10816579|NCT00003645|EG001|Reported Event|Arm II - No Treatment|Arm II: Patients receive no initial treatment.
10816580|NCT00003659|BG000|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
10816581|NCT00003659|FG000|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
10816582|NCT00003659|OG000|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
10816583|NCT00003659|EG000|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
10816584|NCT00003702|BG000|Baseline|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
10816585|NCT00003702|BG001|Baseline|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
10816586|NCT00003702|BG002|Baseline|Total|Total of all reporting groups
10816587|NCT00003702|FG000|Participant Flow|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
10816588|NCT00003702|FG001|Participant Flow|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
10816589|NCT00003702|OG000|Outcome|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
10816590|NCT00003702|OG001|Outcome|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
10816591|NCT00003702|OG000|Outcome|Enrolled Participants|Enrolled participants that had a subsequent hCG measurement after enrollment and before treatment
10816592|NCT00003702|EG000|Reported Event|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
10816593|NCT00003702|EG001|Reported Event|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
10816594|NCT00003782|BG000|Baseline|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
10816595|NCT00003782|BG001|Baseline|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
10816596|NCT00003782|BG002|Baseline|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
10816597|NCT00003782|BG003|Baseline|Total|Total of all reporting groups
10816598|NCT00003782|FG000|Participant Flow|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
10816599|NCT00003782|FG001|Participant Flow|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
10847687|NCT00285207|BG000|Baseline|Placebo|Placebo (no treatment)
10816600|NCT00003782|FG002|Participant Flow|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
10816601|NCT00003782|OG000|Outcome|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
10816602|NCT00003782|OG001|Outcome|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
10816603|NCT00003782|OG002|Outcome|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
10816604|NCT00003782|EG000|Reported Event|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
10816605|NCT00003782|EG001|Reported Event|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
10816606|NCT00003782|EG002|Reported Event|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
10816607|NCT00003816|BG000|Baseline|BuCy|"Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.~busulfan: Given IV~cyclophosphamide: Given IV"
10816608|NCT00003816|BG001|Baseline|CyTBI|"Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.~cyclophosphamide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816609|NCT00003816|BG002|Baseline|FluMel|"Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.~fludarabine phosphate: Given IV~melphalan: Given IV"
10816610|NCT00003816|BG003|Baseline|VpCyTBI|"Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.~cyclophosphamide: Given IV~etoposide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816611|NCT00003816|BG004|Baseline|Other|"Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.~OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2."
10816612|NCT00003816|BG005|Baseline|Total|Total of all reporting groups
10816613|NCT00003816|FG000|Participant Flow|BuCy|"Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.~busulfan: Given IV~cyclophosphamide: Given IV"
10816614|NCT00003816|FG001|Participant Flow|CyTBI|"Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.~cyclophosphamide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816615|NCT00003816|FG002|Participant Flow|FluMel|"Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.~fludarabine phosphate: Given IV~melphalan: Given IV"
10816616|NCT00003816|FG003|Participant Flow|VpCyTBI|"Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.~cyclophosphamide: Given IV~etoposide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816617|NCT00003816|FG004|Participant Flow|Other|Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
10816618|NCT00003816|OG000|Outcome|BuCy|"Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.~busulfan: Given IV~cyclophosphamide: Given IV"
10816619|NCT00003816|OG001|Outcome|CyTBI|"Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.~cyclophosphamide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816620|NCT00003816|OG002|Outcome|FluMel|"Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.~fludarabine phosphate: Given IV~melphalan: Given IV"
10816621|NCT00003816|OG003|Outcome|VpCyTBI|"Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.~cyclophosphamide: Given IV~etoposide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816622|NCT00003816|OG004|Outcome|Other|Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
10816623|NCT00003816|EG000|Reported Event|BuCy|"Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.~busulfan: Given IV~cyclophosphamide: Given IV"
10816624|NCT00003816|EG001|Reported Event|CyTBI|"Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.~cyclophosphamide: Given IV~total-body irradiation: Given twice daily for 3 days"
10847688|NCT00285207|BG001|Baseline|A007|Experimental A007
10847689|NCT00285207|BG002|Baseline|Total|Total of all reporting groups
10847690|NCT00285207|FG000|Participant Flow|Placebo|Placebo (no treatment)
10847691|NCT00285207|FG001|Participant Flow|A007|Experimental A007
10847692|NCT00285207|OG000|Outcome|Placebo|Placebo (no treatment)
10847693|NCT00285207|OG001|Outcome|A007|Experimental A007
11206503|NCT02236338|EG001|Reported Event|Laser Ablation|"Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.~Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.~EVLT 980nm diode laser system"
11206504|NCT02236520|BG000|Baseline|Spironolactone|"50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks~Spironolactone"
11206505|NCT02236520|BG001|Baseline|Chlorthalidone|"25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks~Chlorthalidone"
11206506|NCT02236520|BG002|Baseline|Diet|"diet of 6 g salt per day for 8 weeks~Diet"
11206507|NCT02236520|BG003|Baseline|Placebo|"placebo capsule administered orally 1 per day for 8 weeks~Placebo"
11206508|NCT02236520|BG004|Baseline|Total|Total of all reporting groups
10816625|NCT00003816|EG002|Reported Event|FluMel|"Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.~fludarabine phosphate: Given IV~melphalan: Given IV"
10847694|NCT00285207|EG000|Reported Event|Placebo|Placebo (no treatment)
10847695|NCT00285207|EG001|Reported Event|A007|Experimental A007
10847696|NCT00285246|BG000|Baseline|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
10847697|NCT00285246|FG000|Participant Flow|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
10847698|NCT00285246|OG000|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
10847699|NCT00285246|EG000|Reported Event|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
10847700|NCT00285467|BG000|Baseline|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
10847701|NCT00285467|BG001|Baseline|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
10847702|NCT00285467|BG002|Baseline|Total|Total of all reporting groups
10847703|NCT00285467|FG000|Participant Flow|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
10847704|NCT00285467|FG001|Participant Flow|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
10847705|NCT00285467|OG000|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
10847706|NCT00285467|OG001|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
10847707|NCT00285467|EG000|Reported Event|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
10847708|NCT00285467|EG001|Reported Event|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
10847709|NCT00285584|BG000|Baseline|Bupropion|Participants in this arm received bupropion.
10847710|NCT00285584|BG001|Baseline|Placebo|Participants in this arm received placebo.
10847711|NCT00285584|BG002|Baseline|Total|Total of all reporting groups
10847712|NCT00285584|FG000|Participant Flow|Bupropion|Participants in this arm received bupropion.
10847713|NCT00285584|FG001|Participant Flow|Placebo|Participants in this arm received placebo.
10847714|NCT00285584|OG000|Outcome|Bupropion|6 months
10847715|NCT00285584|OG001|Outcome|Placebo|6 months
10847716|NCT00285584|OG000|Outcome|Bupropion|
10847717|NCT00285584|OG001|Outcome|Placebo|
10847718|NCT00285584|OG000|Outcome|Bupropion|Participants in this arm received bupropion.
10847719|NCT00285584|OG001|Outcome|Placebo|Participants in this arm received placebo.
10847720|NCT00285584|EG000|Reported Event|Bupropion|Participants in this arm received bupropion.
10847721|NCT00285584|EG001|Reported Event|Placebo|Participants in this arm received placebo.
10847722|NCT00285649|BG000|Baseline|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
10847723|NCT00285649|BG001|Baseline|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
10847724|NCT00285649|BG002|Baseline|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
10847725|NCT00285649|BG003|Baseline|Total|Total of all reporting groups
10847726|NCT00285649|FG000|Participant Flow|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
10847727|NCT00285649|FG001|Participant Flow|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
10847728|NCT00285649|FG002|Participant Flow|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
10847729|NCT00285649|OG000|Outcome|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
10847730|NCT00285649|OG001|Outcome|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
10847731|NCT00285649|OG002|Outcome|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
10816626|NCT00003816|EG003|Reported Event|VpCyTBI|"Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.~cyclophosphamide: Given IV~etoposide: Given IV~total-body irradiation: Given twice daily for 3 days"
10816627|NCT00003816|EG004|Reported Event|Other|Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
10816628|NCT00003820|BG000|Baseline|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks
10816629|NCT00003820|FG000|Participant Flow|Rituximab 375 mg/m2 Per Week Inital Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Initial Group of participants prior to the addition of the three extra cycle treatments."
10816630|NCT00003820|FG001|Participant Flow|Rituximab 375 mg/m2 Per Week Secondary Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Secondary Group of participants were added after the addition of the three extra cycle treatments."
10816631|NCT00003820|OG000|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
10816632|NCT00003820|OG000|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks
10816633|NCT00003820|OG000|Outcome|Rituximab 375 mg/m2 Per Week|375 mg/m2 rituximab by IV infusion weekly, assessed after 4 weeks of treatment
10816634|NCT00003820|EG000|Reported Event|Rituximab 375 mg/m2 Per Week|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.~This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group."
10816635|NCT00003830|BG000|Baseline|Conventional Axillary Dissection|Sentinel Node Resection Followed by Conventional Axillary Dissection
10816636|NCT00003830|BG001|Baseline|Sentinel Node Resection Followed by Node Examination|Sentinel node resection followed by node examination
10816637|NCT00003830|BG002|Baseline|Total|Total of all reporting groups
10816638|NCT00003830|FG000|Participant Flow|Arm I: Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
10816639|NCT00003830|FG001|Participant Flow|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
10816640|NCT00003830|OG000|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
10816641|NCT00003830|OG001|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
10816642|NCT00003830|OG000|Outcome|Group 1: Negative Node Patients Without Occult Metastases|Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
10816643|NCT00003830|OG001|Outcome|Group 2: Negative Node Patients With Occult Metastases|Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
10816644|NCT00003830|EG000|Reported Event|Conventional Axillary Dissection|Conventional axillary dissection
10816645|NCT00003830|EG001|Reported Event|Sentinel Node Resection Followed by Node Examination|Sentinel node resection followed by node examination
10816646|NCT00003869|BG000|Baseline|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
10816647|NCT00003869|BG001|Baseline|Placebo|250 mg placebo administered daily
10816648|NCT00003869|BG002|Baseline|Total|Total of all reporting groups
10816649|NCT00003869|FG000|Participant Flow|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
10816650|NCT00003869|FG001|Participant Flow|Placebo|250 mg placebo administered daily
10816651|NCT00003869|OG000|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
10816652|NCT00003869|OG001|Outcome|Placebo|250 mg placebo administered daily
10816653|NCT00003869|EG000|Reported Event|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
10816654|NCT00003869|EG001|Reported Event|Placebo|250 mg placebo administered daily
10816655|NCT00003875|BG000|Baseline|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
10816656|NCT00003875|FG000|Participant Flow|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
11206509|NCT02236520|FG000|Participant Flow|Spironolactone|"50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks~Spironolactone"
10816657|NCT00003875|OG000|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
10816658|NCT00003875|EG000|Reported Event|Treatment|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
10816659|NCT00003895|BG000|Baseline|Arm A (Every 2 Weeks)|
10816660|NCT00003895|BG001|Baseline|Arm B (Every 3 Weeks)|
10816661|NCT00003895|BG002|Baseline|Total|Total of all reporting groups
10816662|NCT00003895|FG000|Participant Flow|gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10816663|NCT00003895|FG001|Participant Flow|gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10816664|NCT00003895|OG000|Outcome|Arm A (Every 2 Weeks, gp100:209-217(210M) and HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10816665|NCT00003895|OG001|Outcome|Arm B (Every 3 Weeks, gp100:209-217(210M) + HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10816666|NCT00003895|EG000|Reported Event|Arm A (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10816667|NCT00003895|EG001|Reported Event|Arm B (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
10822018|NCT00073918|BG000|Baseline|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
10822019|NCT00073918|FG000|Participant Flow|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
10822020|NCT00073918|OG000|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
10847732|NCT00285649|EG000|Reported Event|HVLA-SM*|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
11206510|NCT02236520|FG001|Participant Flow|Chlorthalidone|"25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks~Chlorthalidone"
11206511|NCT02236520|FG002|Participant Flow|Diet|"diet of 6 g salt per day for 8 weeks~Diet"
11206512|NCT02236520|FG003|Participant Flow|Placebo|"placebo capsule administered orally 1 per day for 8 weeks~Placebo"
10967270|NCT00892177|FG000|Participant Flow|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967271|NCT00892177|FG001|Participant Flow|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967272|NCT00892177|FG002|Participant Flow|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967273|NCT00892177|FG003|Participant Flow|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967274|NCT00892177|FG004|Participant Flow|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967275|NCT00892177|FG005|Participant Flow|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967276|NCT00892177|OG000|Outcome|Phase I : Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967277|NCT00892177|OG001|Outcome|Phase I : Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967278|NCT00892177|OG002|Outcome|Phase I : Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967279|NCT00892177|OG003|Outcome|Phase I : Dose Level 3 Cohort 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10816668|NCT00003896|BG000|Baseline|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
10967280|NCT00892177|OG004|Outcome|Phase I: Dose Level 3 Cohort 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967281|NCT00892177|OG000|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967282|NCT00892177|OG001|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967283|NCT00892177|EG000|Reported Event|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967284|NCT00892177|EG001|Reported Event|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967285|NCT00892177|EG002|Reported Event|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967286|NCT00892177|EG003|Reported Event|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967287|NCT00892177|EG004|Reported Event|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967288|NCT00892177|EG005|Reported Event|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967289|NCT00892281|BG000|Baseline|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
10967290|NCT00892281|BG001|Baseline|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
10967291|NCT00892281|BG002|Baseline|Total|Total of all reporting groups
10967292|NCT00892281|FG000|Participant Flow|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
10967293|NCT00892281|FG001|Participant Flow|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
10967294|NCT00892281|OG000|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
10967295|NCT00892281|OG001|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
11206513|NCT02236520|OG000|Outcome|Spironolactone|"50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks~Spironolactone"
11206514|NCT02236520|OG001|Outcome|Chlorthalidone|"25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks~Chlorthalidone"
10816669|NCT00003896|FG000|Participant Flow|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
10816670|NCT00003896|OG000|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
10816671|NCT00003896|OG000|Outcome|Paclitaxel/CDDP/Liposomal Doxorubicin|
10816672|NCT00003896|EG000|Reported Event|Paclitaxel/CDDP/Liposomal Doxorubicin|
10816673|NCT00003901|BG000|Baseline|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
10816674|NCT00003901|FG000|Participant Flow|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
10816675|NCT00003901|OG000|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
10816676|NCT00003901|OG001|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
10816677|NCT00003901|OG000|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
10816678|NCT00003901|OG001|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
10816679|NCT00003901|EG000|Reported Event|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
10816680|NCT00003907|BG000|Baseline|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816681|NCT00003907|BG001|Baseline|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816682|NCT00003907|BG002|Baseline|Total|Total of all reporting groups
10816683|NCT00003907|FG000|Participant Flow|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816684|NCT00003907|FG001|Participant Flow|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816685|NCT00003907|OG000|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816686|NCT00003907|OG001|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816687|NCT00003907|EG000|Reported Event|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816688|NCT00003907|EG001|Reported Event|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
10816689|NCT00003910|BG000|Baseline|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
10816690|NCT00003910|FG000|Participant Flow|Methotrexate|"MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month.~If no response, then pt went onto step 2 and received CY."
10816691|NCT00003910|FG001|Participant Flow|Cyclophosphomide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
10816692|NCT00003910|OG000|Outcome|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
10816693|NCT00003910|OG000|Outcome|Cyclophosphamide (Cy)|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule. In patients showing a partial response, but not a CR, the maximum period of therapy was 1 year.
10816694|NCT00003910|EG000|Reported Event|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
10816695|NCT00003910|EG001|Reported Event|Cyclophosphamide|step 2 patients who received CY
10816696|NCT00004031|BG000|Baseline|CHOP/CHOP-R x 3|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~cyclophosphamide~doxorubicin hydrochloride~prednisone~vincristine sulfate~bone marrow ablation with stem cell support"
10967296|NCT00892281|EG000|Reported Event|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
11206515|NCT02236520|OG002|Outcome|Diet|"diet of 6 g salt per day for 8 weeks~Diet"
11206516|NCT02236520|OG003|Outcome|Placebo|"placebo capsule administered orally 1 per day for 8 weeks~Placebo"
11206517|NCT02236520|EG000|Reported Event|Spironolactone|"50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks~Spironolactone"
11206518|NCT02236520|EG001|Reported Event|Chlorthalidone|"25 mg capsule of Chlorthalidone administered orally 1 per day for 8 weeks~Chlorthalidone"
11206519|NCT02236520|EG002|Reported Event|Diet|"diet of 6 g salt per day for 8 weeks~Diet"
11206520|NCT02236520|EG003|Reported Event|Placebo|"placebo capsule administered orally 1 per day for 8 weeks~Placebo"
10967297|NCT00892281|EG001|Reported Event|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
10967298|NCT00892437|BG000|Baseline|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
10967299|NCT00892437|BG001|Baseline|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
10967300|NCT00892437|BG002|Baseline|Total|Total of all reporting groups
10967301|NCT00892437|FG000|Participant Flow|ATV+COBI+FTC/TDF|"Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
10967302|NCT00892437|FG001|Participant Flow|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
10967303|NCT00892437|OG000|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
10967304|NCT00892437|OG001|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
11244359|NCT02510014|EG001|Reported Event|Roll-over Subjects|Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
10967305|NCT00892437|EG000|Reported Event|ATV+COBI+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60.
10967306|NCT00892437|EG001|Reported Event|ATV+RTV+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60.
10967307|NCT00892437|EG002|Reported Event|All ATV+COBI+FTC/TDF|The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
10967308|NCT00892606|BG000|Baseline|Methadone|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation
10967309|NCT00892606|BG001|Baseline|Control|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine
10967310|NCT00892606|BG002|Baseline|Total|Total of all reporting groups
10967311|NCT00892606|FG000|Participant Flow|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
10967312|NCT00892606|FG001|Participant Flow|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
10967313|NCT00892606|OG000|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
10967314|NCT00892606|OG001|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
10967315|NCT00892606|EG000|Reported Event|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
10967316|NCT00892606|EG001|Reported Event|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
10967317|NCT00892697|BG000|Baseline|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
10967318|NCT00892697|FG000|Participant Flow|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
11092528|NCT01540474|FG001|Participant Flow|Group 2: 10 ug FMP012 With 5 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11244360|NCT02510144|BG000|Baseline|Chlorhexidine|"A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)~Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery"
11244361|NCT02510144|BG001|Baseline|Benzoyl Peroxide|"A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)~Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery"
11244362|NCT02510144|BG002|Baseline|Total|Total of all reporting groups
11244363|NCT02510144|FG000|Participant Flow|Chlorhexidine|"A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)~Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery"
10816697|NCT00004031|BG001|Baseline|CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~carmustine~cyclophosphamide~doxorubicin hydrochloride~etoposide~prednisone~vincristine sulfate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation~radiation therapy"
10816698|NCT00004031|BG002|Baseline|Total|Total of all reporting groups
10816699|NCT00004031|FG000|Participant Flow|CHOP/CHOP-R x 3|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~cyclophosphamide~doxorubicin hydrochloride~prednisone~vincristine sulfate~bone marrow ablation with stem cell support"
10816700|NCT00004031|FG001|Participant Flow|CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~carmustine~cyclophosphamide~doxorubicin hydrochloride~etoposide~prednisone~vincristine sulfate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation~radiation therapy"
10816701|NCT00004031|OG000|Outcome|CHOP/CHOP-R x 3|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~cyclophosphamide~doxorubicin hydrochloride~prednisone~vincristine sulfate~bone marrow ablation with stem cell support"
10816702|NCT00004031|OG001|Outcome|CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant|"Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.~rituximab: 375 mg/m2 IV every 21 days~CHOP regimen~carmustine~cyclophosphamide~doxorubicin hydrochloride~etoposide~prednisone~vincristine sulfate~bone marrow ablation with stem cell support~peripheral blood stem cell transplantation~radiation therapy"
10816703|NCT00004031|OG000|Outcome|CHOP/CHOP-R x 3|Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support
10816704|NCT00004031|OG001|Outcome|CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant|Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
10816705|NCT00004031|EG000|Reported Event|CHOP/CHOP-R x 3|Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cyclesXXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcyclophosphamideXXdoxorubicin hydrochlorideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell support
10816706|NCT00004031|EG001|Reported Event|CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant|Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.XXrituximab: 375 mg/m2 IV every 21 daysXXCHOP regimenXXcarmustineXXcyclophosphamideXXdoxorubicin hydrochlorideXXetoposideXXprednisoneXXvincristine sulfateXXbone marrow ablation with stem cell supportXXperipheral blood stem cell transplantationXXradiation therapy
10816707|NCT00004054|BG000|Baseline|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
10816708|NCT00004054|BG001|Baseline|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
10816709|NCT00004054|BG002|Baseline|Total|Total of all reporting groups
10816710|NCT00004054|FG000|Participant Flow|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
10816711|NCT00004054|FG001|Participant Flow|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
10816712|NCT00004054|OG000|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
10816713|NCT00004054|OG001|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
10816714|NCT00004054|EG000|Reported Event|Hormones and RT|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.
10816715|NCT00004054|EG001|Reported Event|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
10816716|NCT00004088|BG000|Baseline|HD Chemo Followed by PBPC Rescue|HD Melphalan/Cyclophosphamide followed by PBPC Rescue, alpha-interferon, & pamidronate
10816717|NCT00004088|FG000|Participant Flow|High-dose Chemotherapy Followed by PBPC Rescue|"Priming and Apheresis: Cyclophosphamide (CTX) 1.5 g/m2 and Filgrastim, 5 microgram/kg, t2x/day, until enough PBPC have been collected. This is day -10 to the first transplant.~Cycle (transplant) 1: day -1: Melphalan 150 mg/m2 IV; day 0: reinfusion of half of the collected stem cells; day +1: Filgrastim 5 micrograms/kg/day IV until ANC>1000 per microliter.~Day 0 of cycle 2 (C2) is at least 12 weeks and not past 18 weeks from day 1 of cycle 1. Day -8 C2: Start Dilantin 1000 mg IV. Days -7 through -4 of C2: Busulfan 0.8 mg/kg every 6 hours, 4 x per day. Dilantin 300 micrograms/day. Day -3 C2: CTX 60 mg/kg; start IV Mesna. Day -2 C2: CTX 60 mg/kg; continue Mesna IV. Day 0 C2: Reinfuse PBPC. Start Filgrastim 5 microgram/kg daily.~12-18 weeks from day 0 of C2: alpha interferon 3 x 10 E 6 units/m2 3x per week (TIW) for 3 years.~At 6 months following day 0 of C2, Thalidomide 400 mg/m2 will be administered orally to patients not in Complete Remission."
10816718|NCT00004088|OG000|Outcome|HD Chemo Followed by PBPC Rescue|"Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.~filgrastim~recombinant interferon alfa~busulfan~cyclophosphamide~melphalan~pamidronate disodium~thalidomide~peripheral blood stem cell transplantation"
10816719|NCT00004088|EG000|Reported Event|HD Chemo Followed by PBPC Rescue|"Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.~filgrastim~recombinant interferon alfa~busulfan~cyclophosphamide~melphalan~pamidronate disodium~thalidomide~peripheral blood stem cell transplantation"
10816720|NCT00004092|BG000|Baseline|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816721|NCT00004092|BG001|Baseline|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816722|NCT00004092|BG002|Baseline|Total|Total of all reporting groups
10816723|NCT00004092|FG000|Participant Flow|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816724|NCT00004092|FG001|Participant Flow|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816725|NCT00004092|OG000|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
11244364|NCT02510144|FG001|Participant Flow|Benzoyl Peroxide|"A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)~Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery"
10816726|NCT00004092|OG001|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10967319|NCT00892697|OG000|Outcome|Telaprevir/Peg-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
10967320|NCT00892697|OG000|Outcome|Telaprevir/PEG-IFN/RBV|15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
10967321|NCT00892697|EG000|Reported Event|Telaprevir/PEG-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
10967322|NCT00892710|BG000|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
10967323|NCT00892710|BG001|Baseline|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
10967324|NCT00892710|BG002|Baseline|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
10967325|NCT00892710|BG003|Baseline|Total|Total of all reporting groups
10967326|NCT00892710|FG000|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
10967327|NCT00892710|FG001|Participant Flow|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
10967328|NCT00892710|FG002|Participant Flow|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
10967329|NCT00892710|OG000|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
10967330|NCT00892710|OG001|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
10967331|NCT00892710|OG002|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
10967332|NCT00892710|EG000|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
10967333|NCT00892710|EG001|Reported Event|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
11244365|NCT02510144|OG000|Outcome|Chlorhexidine|"A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)~Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery"
10967334|NCT00892710|EG002|Reported Event|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
10967335|NCT00892723|BG000|Baseline|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967336|NCT00892723|BG001|Baseline|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967337|NCT00892723|BG002|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967338|NCT00892723|BG003|Baseline|Total|Total of all reporting groups
10967339|NCT00892723|FG000|Participant Flow|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967340|NCT00892723|FG001|Participant Flow|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967341|NCT00892723|FG002|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967342|NCT00892723|OG000|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967343|NCT00892723|OG001|Outcome|PSAS Results for 0.3 mg AZX100|This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967344|NCT00892723|OG002|Outcome|PSAS Results for 1 mg AZX100|This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967345|NCT00892723|OG003|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967346|NCT00892723|OG004|Outcome|OSAS Results for 0.3 mg AZX100|This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967347|NCT00892723|OG005|Outcome|OSAS Results for 1 mg AZX100|This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967348|NCT00892723|OG000|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967349|NCT00892723|OG001|Outcome|Rater 1 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967350|NCT00892723|OG002|Outcome|Rater 1 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967351|NCT00892723|OG003|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967352|NCT00892723|OG004|Outcome|Rater 2 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967353|NCT00892723|OG005|Outcome|Rater 2 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967354|NCT00892723|OG000|Outcome|Scar Length - Placebo|This group included Month 12 scar length measurements (mm)for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967355|NCT00892723|OG001|Outcome|Scar Length - 0.3 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967356|NCT00892723|OG002|Outcome|Scar Length - 1 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967357|NCT00892723|OG003|Outcome|Scar Width - Placebo|This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967358|NCT00892723|OG004|Outcome|Scar Width - 0.3 mg AZX100|This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967359|NCT00892723|OG005|Outcome|Scar Width - 1 mg AZX100|This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967360|NCT00892723|OG006|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967361|NCT00892723|OG007|Outcome|Scar Minimum Elevation - 0.3 mg AZX100|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967362|NCT00892723|OG008|Outcome|Scar Minimum Elevation - 1 mg AZX100|This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967363|NCT00892723|OG009|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967364|NCT00892723|OG010|Outcome|Scar Maximum Elevation - 0.3 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967365|NCT00892723|OG011|Outcome|Scar Maximum Elevation - 1 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967366|NCT00892723|OG012|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967367|NCT00892723|OG013|Outcome|Scar Mean Elevation - 0.3 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967368|NCT00892723|OG014|Outcome|Scar Mean Elevation - 1 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967369|NCT00892723|OG000|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967370|NCT00892723|OG001|Outcome|Scar Positive Volume - 0.3 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 0.3 mg AZx100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967371|NCT00892723|OG002|Outcome|Scar Positive Volume - 1 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967372|NCT00892723|OG003|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967373|NCT00892723|OG004|Outcome|Scar Negative Volume - 0.3 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967374|NCT00892723|OG005|Outcome|Scar Negative Volume - 1 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967375|NCT00892723|OG006|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
11244366|NCT02510144|OG001|Outcome|Benzoyl Peroxide|"A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)~Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery"
11244367|NCT02510144|EG000|Reported Event|Chlorhexidine|"A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)~Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery"
11206521|NCT02236559|BG000|Baseline|Noninvasive Positive Pressure Ventilation (NiPPV)|Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of Noninvasive positive-pressure ventilation (NiPPV). NiPPV(Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
11244368|NCT02510144|EG001|Reported Event|Benzoyl Peroxide|"A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)~Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery"
10816727|NCT00004092|EG000|Reported Event|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816728|NCT00004092|EG001|Reported Event|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
10816729|NCT00004124|BG000|Baseline|Arm I: Bicalutamide + Goserelin|Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
10816730|NCT00004124|BG001|Baseline|Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin|Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
10816731|NCT00004124|BG002|Baseline|Total|Total of all reporting groups
10816732|NCT00004124|FG000|Participant Flow|Arm I: Bicalutamide + Goserelin|Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
10816733|NCT00004124|FG001|Participant Flow|Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin|Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
10816734|NCT00004124|OG000|Outcome|Arm I: Bicalutamide + Goserelin|Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
10816735|NCT00004124|OG001|Outcome|Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin|Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
10816736|NCT00004124|EG000|Reported Event|Arm I: Bicalutamide + Goserelin|Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
10816737|NCT00004124|EG001|Reported Event|Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin|Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
10816738|NCT00004143|BG000|Baseline|All Patients|
10816739|NCT00004143|FG000|Participant Flow|All Patients|
10816740|NCT00004143|OG000|Outcome|All Patients|
10816741|NCT00004143|EG000|Reported Event|All Patients|
10816742|NCT00004146|BG000|Baseline|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
10816743|NCT00004146|FG000|Participant Flow|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
10816744|NCT00004146|OG000|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
10816745|NCT00004146|OG000|Outcome|CAI With RT + Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
10816746|NCT00004146|OG001|Outcome|CAI With RT Without Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
10816747|NCT00004146|EG000|Reported Event|Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
11206522|NCT02236559|BG001|Baseline|High Velocity Nasal Insufflation (HVNI)|Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of High Velocity Nasal Insufflation (HVNI). HVNI (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
11206523|NCT02236559|BG002|Baseline|Total|Total of all reporting groups
10967376|NCT00892723|OG007|Outcome|Scar Total Volume - 0.3 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967377|NCT00892723|OG008|Outcome|Scar Total Volume - 1 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
10967378|NCT00892723|EG000|Reported Event|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967379|NCT00892723|EG001|Reported Event|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967380|NCT00892723|EG002|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
10967381|NCT00892775|BG000|Baseline|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
10967382|NCT00892775|BG001|Baseline|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
10967383|NCT00892775|BG002|Baseline|Total|Total of all reporting groups
10967384|NCT00892775|FG000|Participant Flow|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
10967385|NCT00892775|FG001|Participant Flow|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
10967386|NCT00892775|OG000|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
10967387|NCT00892775|OG001|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
10967388|NCT00892775|EG000|Reported Event|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
10967389|NCT00892775|EG001|Reported Event|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
10967390|NCT00892957|BG000|Baseline|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
11206524|NCT02236559|FG000|Participant Flow|Noninvasive Positive Pressure Ventilation|Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
10967391|NCT00892957|BG001|Baseline|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
10967392|NCT00892957|BG002|Baseline|Total|Total of all reporting groups
10967393|NCT00892957|FG000|Participant Flow|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
10967394|NCT00892957|FG001|Participant Flow|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
10967395|NCT00892957|OG000|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
10967396|NCT00892957|OG001|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
10967397|NCT00892957|OG000|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
10967398|NCT00892957|OG001|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
10967399|NCT00892957|OG002|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
10967400|NCT00892957|OG003|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
10967401|NCT00892957|OG004|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
10967402|NCT00892957|OG005|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
10967403|NCT00892957|OG000|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
10967404|NCT00892957|OG001|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
10967405|NCT00892957|OG002|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
10967406|NCT00892957|OG003|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
10967407|NCT00892957|OG000|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
10967408|NCT00892957|OG001|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
10967409|NCT00892957|OG002|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
10967410|NCT00892957|OG003|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
10967411|NCT00892957|EG000|Reported Event|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
10816748|NCT00004228|BG000|Baseline|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
10816749|NCT00004228|BG001|Baseline|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
10816750|NCT00004228|BG002|Baseline|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816751|NCT00004228|BG003|Baseline|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816752|NCT00004228|BG004|Baseline|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816753|NCT00004228|BG005|Baseline|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816754|NCT00004228|BG006|Baseline|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816755|NCT00004228|BG007|Baseline|Total|Total of all reporting groups
10816756|NCT00004228|FG000|Participant Flow|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
10816757|NCT00004228|FG001|Participant Flow|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
10967412|NCT00892957|EG001|Reported Event|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
10967413|NCT00893074|BG000|Baseline|Study Participant|Participants who received active drug as part of the study
10816758|NCT00004228|FG002|Participant Flow|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816759|NCT00004228|FG003|Participant Flow|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10847733|NCT00285649|EG001|Reported Event|LVVA-SM*|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
10847734|NCT00285649|EG002|Reported Event|Usual Medical Care*|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
10847735|NCT00285779|BG000|Baseline|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
10847736|NCT00285779|BG001|Baseline|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
10847737|NCT00285779|BG002|Baseline|Total|Total of all reporting groups
10847738|NCT00285779|FG000|Participant Flow|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
10847739|NCT00285779|FG001|Participant Flow|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
10847740|NCT00285779|OG000|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
10847741|NCT00285779|OG001|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
10847742|NCT00285779|EG000|Reported Event|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
10847743|NCT00285779|EG001|Reported Event|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
10847744|NCT00285818|BG000|Baseline|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847745|NCT00285818|BG001|Baseline|Placebo|"Patients receive a placebo pill one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847746|NCT00285818|BG002|Baseline|Total|Total of all reporting groups
10847747|NCT00285818|FG000|Participant Flow|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847748|NCT00285818|FG001|Participant Flow|Placebo|"Patients receive a placebo capsule one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847749|NCT00285818|OG000|Outcome|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847750|NCT00285818|OG001|Outcome|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
10847751|NCT00285818|EG000|Reported Event|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
10847752|NCT00285818|EG001|Reported Event|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
10847753|NCT00285857|BG000|Baseline|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
10847754|NCT00285857|FG000|Participant Flow|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
10847755|NCT00285857|OG000|Outcome|Baseline Non-proliferative Breast Disease (NPBD)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease
10847756|NCT00285857|OG001|Outcome|Baseline Proliferative Breast Disease Without Atypia (PBD-A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia
10847757|NCT00285857|OG002|Outcome|Baseline Proliferative Breast Disease With Atypia (PBD+A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia
10847758|NCT00285857|OG003|Outcome|Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer
10847759|NCT00285857|OG004|Outcome|Baseline Biopsy Acellular|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular
10847760|NCT00285857|OG000|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
10847761|NCT00285857|EG000|Reported Event|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
10847762|NCT00286078|BG000|Baseline|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
10847763|NCT00286078|BG001|Baseline|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
10847764|NCT00286078|BG002|Baseline|Total|Total of all reporting groups
10847765|NCT00286078|FG000|Participant Flow|Treatment|"Active occipital nerve stimulation (stimulation on).~Precision: Implantable neurostimulator"
10847766|NCT00286078|FG001|Participant Flow|Control|Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
10816760|NCT00004228|FG004|Participant Flow|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816761|NCT00004228|FG005|Participant Flow|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816762|NCT00004228|FG006|Participant Flow|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816763|NCT00004228|OG000|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
10816764|NCT00004228|OG001|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
10816765|NCT00004228|OG002|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816766|NCT00004228|OG003|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816767|NCT00004228|OG004|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816768|NCT00004228|OG005|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10847767|NCT00286078|OG000|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
10847768|NCT00286078|OG001|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
10847769|NCT00286078|EG000|Reported Event|Treatment|"Active occipital nerve stimulation (stimulation on)~Precision: Implantable neurostimulator"
10816769|NCT00004228|OG006|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816770|NCT00004228|OG002|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816771|NCT00004228|EG000|Reported Event|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
10816772|NCT00004228|EG001|Reported Event|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
10816773|NCT00004228|EG002|Reported Event|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
10816774|NCT00004228|EG003|Reported Event|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816775|NCT00004228|EG004|Reported Event|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816776|NCT00004228|EG005|Reported Event|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816777|NCT00004228|EG006|Reported Event|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
10816778|NCT00004259|BG000|Baseline|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
10816779|NCT00004259|BG001|Baseline|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
10816780|NCT00004259|BG002|Baseline|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
10816781|NCT00004259|BG003|Baseline|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
10816782|NCT00004259|BG004|Baseline|Total|Total of all reporting groups
10816783|NCT00004259|FG000|Participant Flow|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
10816784|NCT00004259|FG001|Participant Flow|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
10816785|NCT00004259|FG002|Participant Flow|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
10816786|NCT00004259|FG003|Participant Flow|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
10816787|NCT00004259|OG000|Outcome|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
10816788|NCT00004259|OG001|Outcome|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
10816789|NCT00004259|OG000|Outcome|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
10816790|NCT00004259|OG001|Outcome|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
10816791|NCT00004259|OG000|Outcome|Methylated MGMT|
10816792|NCT00004259|OG001|Outcome|Unmthylated MGMT|
10816793|NCT00004259|OG000|Outcome|Methylated MGMT|Patients with MGMT menthylated status
10816794|NCT00004259|EG000|Reported Event|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
10816795|NCT00004259|EG001|Reported Event|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
10816796|NCT00004259|EG002|Reported Event|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
10816797|NCT00004259|EG003|Reported Event|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
10816798|NCT00004412|BG000|Baseline|Standard Local Care Dressing|Standard local care dressing including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
10816799|NCT00004412|BG001|Baseline|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
10816800|NCT00004412|BG002|Baseline|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
10816801|NCT00004412|BG003|Baseline|Total|Total of all reporting groups
10816802|NCT00004412|FG000|Participant Flow|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
10816803|NCT00004412|FG001|Participant Flow|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
10816804|NCT00004412|FG002|Participant Flow|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Allevyn Hydrophilic PU dressing (standard local care) only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
10816805|NCT00004412|OG000|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
10816806|NCT00004412|OG001|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
10816807|NCT00004412|EG000|Reported Event|Standard Local Care Dressing|Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
10816808|NCT00004412|EG001|Reported Event|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
10816809|NCT00004418|BG000|Baseline|GTO/GTE Treatment|"Intervention: A mixture of glycerol trierucate (GTE) in glycerol trioleate (GTO) in combination with a diet low in saturated fats.~GTO/GTE orally; 30-60 ml daily for study period~glyceryl trierucate: Glyceryl trierucate is an oil to reduce very long chain fatty acids~glyceryl trioleate: Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily."
10816810|NCT00004418|FG000|Participant Flow|GTO/GTE Treatment|"Intervention: A mixture of glycerol trierucate (GTE) in glycerol trioleate (GTO) in combination with a diet low in saturated fats.~GTO/GTE orally; 30-60 ml daily for study period~glyceryl trierucate: Glyceryl trierucate is an oil to reduce very long chain fatty acids~glyceryl trioleate: Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily."
10816811|NCT00004418|OG000|Outcome|GTO/GTE Treatment|"Intervention: A mixture of glycerol trierucate (GTE) in glycerol trioleate (GTO) in combination with a diet low in saturated fats.~GTO/GTE orally; 30-60 ml daily for study period~glyceryl trierucate: Glyceryl trierucate is an oil to reduce very long chain fatty acids~glyceryl trioleate: Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily."
10816812|NCT00004418|EG000|Reported Event|GTO/GTE Treatment|"Intervention: A mixture of glycerol trierucate (GTE) in glycerol trioleate (GTO) in combination with a diet low in saturated fats.~GTO/GTE orally; 30-60 ml daily for study period~glyceryl trierucate: Glyceryl trierucate is an oil to reduce very long chain fatty acids~glyceryl trioleate: Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily."
10816813|NCT00004445|BG000|Baseline|Implanted Neuroprosthesis|"Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures.~Surgery~IRS-8"
10967414|NCT00893074|FG000|Participant Flow|0, 30, 60, and 120mg Dronabinol|0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants
10967415|NCT00893074|OG000|Outcome|Placebo|0mg daily dronabinol administered for 5 days
10967416|NCT00893074|OG001|Outcome|30mg Dronabinol|30mg daily dronabinol (10mg tid) administered for 5 days
10967417|NCT00893074|OG002|Outcome|60mg Dronabinol|60mg daily dronabinol (20mg tid) administered for 5 days
10967418|NCT00893074|OG003|Outcome|120mg Dronabinol|120mg daily dronabinol (40mg tid) administered for 5 days
11244369|NCT02510664|BG000|Baseline|Adolescent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10816814|NCT00004445|FG000|Participant Flow|Implanted Neuroprosthesis|"Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures.~Surgery~IRS-8"
10967419|NCT00893074|OG000|Outcome|Placebo|Placebo dronabinol maintenance
10967420|NCT00893074|OG001|Outcome|30mg Dronabinol|30mg (10mg tid) dronabinol maintenance
10967421|NCT00893074|OG002|Outcome|60mg Dronabinol|60mg (20mg tid) dronabinol maintenance
10967422|NCT00893074|OG003|Outcome|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
10967423|NCT00893074|OG000|Outcome|Placebo|placebo dronabinol maintenance
10967424|NCT00893074|EG000|Reported Event|Placebo|Placebo maintenance
10967425|NCT00893074|EG001|Reported Event|30mg|30mg dronabinol maintenance
10967426|NCT00893074|EG002|Reported Event|60mg|60mg dronabinol maintenance
10967427|NCT00893074|EG003|Reported Event|120mg|120mg dronabinol maintenance
10967428|NCT00893113|BG000|Baseline|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
10967429|NCT00893113|BG001|Baseline|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
10967430|NCT00893113|BG002|Baseline|Total|Total of all reporting groups
10967431|NCT00893113|FG000|Participant Flow|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
10967432|NCT00893113|FG001|Participant Flow|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
10967433|NCT00893113|OG000|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
10967434|NCT00893113|OG001|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
10967435|NCT00893113|EG000|Reported Event|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
10967436|NCT00893113|EG001|Reported Event|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
10967437|NCT00893152|BG000|Baseline|Veterans|Participants in focus groups or individual qualitative interviews
10967438|NCT00893152|BG001|Baseline|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
10967439|NCT00893152|BG002|Baseline|Total|Total of all reporting groups
10967440|NCT00893152|FG000|Participant Flow|Veterans|Participants in focus groups or individual qualitative interviews
10967441|NCT00893152|FG001|Participant Flow|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
10967442|NCT00893152|OG000|Outcome|Veterans|Participants in focus groups or individual qualitative interviews
10967443|NCT00893152|OG001|Outcome|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
10967444|NCT00893152|EG000|Reported Event|Veterans|Participants in focus groups or individual qualitative interviews
10967445|NCT00893152|EG001|Reported Event|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
10967446|NCT00893464|BG000|Baseline|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967447|NCT00893464|BG001|Baseline|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967448|NCT00893464|BG002|Baseline|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967449|NCT00893464|BG003|Baseline|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967450|NCT00893464|BG004|Baseline|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10816815|NCT00004445|OG000|Outcome|Implanted Neuroprosthesis|"Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.~Interventions include:~Procedure/Surgery Rehabilitation/Exercise~Device includes:~IRS-8 Stimulating Electrodes External Controller~Surgery~IRS-8"
10816816|NCT00004445|EG000|Reported Event|Implanted Neuroprosthesis|"Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures.~Surgery~IRS-8"
10816817|NCT00004500|BG000|Baseline|Lucinactant|Lucinactant via bronchoaveolar lavage
10816818|NCT00004500|BG001|Baseline|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
10816819|NCT00004500|BG002|Baseline|Total|Total of all reporting groups
10816820|NCT00004500|FG000|Participant Flow|Lucinactant|Lucinactant via bronchoaveolar lavage
10816821|NCT00004500|FG001|Participant Flow|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
10816822|NCT00004500|OG000|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
10816823|NCT00004500|OG001|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
10816824|NCT00004500|EG000|Reported Event|Lucinactant|Lucinactant via bronchoaveolar lavage
10816825|NCT00004500|EG001|Reported Event|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
10816826|NCT00004547|BG000|Baseline|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
10816827|NCT00004547|BG001|Baseline|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
10816828|NCT00004547|BG002|Baseline|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
10816829|NCT00004547|BG003|Baseline|Total|Total of all reporting groups
10816830|NCT00004547|FG000|Participant Flow|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
10816831|NCT00004547|FG001|Participant Flow|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
10816832|NCT00004547|FG002|Participant Flow|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
10816833|NCT00004547|OG000|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
10816834|NCT00004547|OG001|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
10816835|NCT00004547|OG002|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
10816836|NCT00004547|OG000|Outcome|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
10816837|NCT00004547|OG000|Outcome|Normal Tissue|Non-diseased tissue
10816838|NCT00004547|OG001|Outcome|Tumor Tissue|Diseased tissue
10967451|NCT00893464|BG005|Baseline|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967452|NCT00893464|BG006|Baseline|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967453|NCT00893464|BG007|Baseline|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967454|NCT00893464|BG008|Baseline|Total|Total of all reporting groups
10967455|NCT00893464|FG000|Participant Flow|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity.
10967456|NCT00893464|FG001|Participant Flow|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967457|NCT00893464|FG002|Participant Flow|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967458|NCT00893464|FG003|Participant Flow|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967459|NCT00893464|FG004|Participant Flow|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708) 1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967460|NCT00893464|FG005|Participant Flow|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967461|NCT00893464|FG006|Participant Flow|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967462|NCT00893464|FG007|Participant Flow|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
11206525|NCT02236559|FG001|Participant Flow|High Velocity Nasal Insufflation|High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
10967463|NCT00893464|OG000|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967464|NCT00893464|OG001|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967465|NCT00893464|OG002|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967466|NCT00893464|OG003|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967467|NCT00893464|OG004|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967468|NCT00893464|OG005|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967469|NCT00893464|OG006|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967470|NCT00893464|OG007|Outcome|Ixazomib 3.11 mg/m²|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967471|NCT00893464|OG005|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967472|NCT00893464|OG007|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967473|NCT00893464|OG000|Outcome|All Participants|All participants who received ixazomib (MLN9708) 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 or 3.11 mg/m^2 in dose-escalation cohorts .
10967474|NCT00893464|OG000|Outcome|All Participants|All participants who received MLN9708 at dose 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 and 3.11 mg/m^2 in Phase 1.
10967475|NCT00893464|OG000|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity..
10967476|NCT00893464|EG000|Reported Event|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967477|NCT00893464|EG001|Reported Event|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967478|NCT00893464|EG002|Reported Event|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967479|NCT00893464|EG003|Reported Event|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967480|NCT00893464|EG004|Reported Event|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10816839|NCT00004547|EG000|Reported Event|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
10816840|NCT00004562|BG000|Baseline|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
10816841|NCT00004562|BG001|Baseline|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
10816842|NCT00004562|BG002|Baseline|Total|Total of all reporting groups
10816843|NCT00004562|FG000|Participant Flow|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
10816844|NCT00004562|FG001|Participant Flow|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
10816845|NCT00004562|OG000|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
10816846|NCT00004562|OG001|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
10816847|NCT00004562|EG000|Reported Event|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
10816848|NCT00004562|EG001|Reported Event|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
10816849|NCT00004563|BG000|Baseline|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
10816850|NCT00004563|BG001|Baseline|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
10816851|NCT00004563|BG002|Baseline|Total|Total of all reporting groups
10816852|NCT00004563|FG000|Participant Flow|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
10816853|NCT00004563|FG001|Participant Flow|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
10816854|NCT00004563|OG000|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
10816855|NCT00004563|OG001|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
10816856|NCT00004563|EG000|Reported Event|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
10816857|NCT00004563|EG001|Reported Event|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
10816858|NCT00004635|BG000|Baseline|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
10816859|NCT00004635|BG001|Baseline|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
10816860|NCT00004635|BG002|Baseline|Total|Total of all reporting groups
10816861|NCT00004635|FG000|Participant Flow|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
10847770|NCT00286078|EG001|Reported Event|Control|"Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
10967481|NCT00893464|EG005|Reported Event|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967482|NCT00893464|EG006|Reported Event|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967483|NCT00893464|EG007|Reported Event|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
10967484|NCT00893737|BG000|Baseline|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
10967485|NCT00893737|FG000|Participant Flow|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
10967486|NCT00893737|OG000|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
10967487|NCT00893737|EG000|Reported Event|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
10967488|NCT00893763|BG000|Baseline|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
10967489|NCT00893763|BG001|Baseline|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
10967490|NCT00893763|BG002|Baseline|Total|Total of all reporting groups
10967491|NCT00893763|FG000|Participant Flow|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
10967492|NCT00893763|FG001|Participant Flow|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
10967493|NCT00893763|OG000|Outcome|1: Preintubation Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
10967494|NCT00893763|OG001|Outcome|2: COntrol|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
10967495|NCT00893763|OG000|Outcome|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
10967496|NCT00893763|OG001|Outcome|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
10967497|NCT00893763|EG000|Reported Event|1: Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
10967498|NCT00893763|EG001|Reported Event|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
10967499|NCT00893971|BG000|Baseline|All Subjects|Any treatment arm
10967500|NCT00893971|FG000|Participant Flow|Overall Study|All patients randomized
10967501|NCT00893971|OG000|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
10967502|NCT00893971|OG001|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
10967503|NCT00893971|OG002|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
10967504|NCT00893971|OG003|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
10967505|NCT00893971|OG001|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
10967506|NCT00893971|OG002|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
10967507|NCT00893971|OG000|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
10967508|NCT00893971|EG000|Reported Event|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
10967509|NCT00893971|EG001|Reported Event|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
10967510|NCT00893971|EG002|Reported Event|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
10967511|NCT00893971|EG003|Reported Event|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
10967512|NCT00893984|BG000|Baseline|Nebivolol|"Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.~Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control."
10967513|NCT00893984|FG000|Participant Flow|Nebivolol|"Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.~Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control."
10967514|NCT00893984|OG000|Outcome|Nebivolol|"Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.~Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control."
10967515|NCT00893984|EG000|Reported Event|Nebivolol|"Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.~Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control."
10967516|NCT00893997|BG000|Baseline|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
10967517|NCT00893997|FG000|Participant Flow|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
10967518|NCT00893997|OG000|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
10967519|NCT00893997|EG000|Reported Event|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
10967520|NCT00894127|BG000|Baseline|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
10967521|NCT00894127|FG000|Participant Flow|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
10967522|NCT00894127|OG000|Outcome|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
10967523|NCT00894127|EG000|Reported Event|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
10967524|NCT00894166|BG000|Baseline|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
10967525|NCT00894166|BG001|Baseline|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
10967526|NCT00894166|BG002|Baseline|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
10967527|NCT00894166|BG003|Baseline|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
10967528|NCT00894166|BG004|Baseline|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
11244370|NCT02510664|BG001|Baseline|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments"
11286176|NCT02885025|BG000|Baseline|BSE + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis."
10967529|NCT00894166|BG005|Baseline|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
10967530|NCT00894166|BG006|Baseline|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
10967531|NCT00894166|BG007|Baseline|Withdrew Prior to Randomization|These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
10967532|NCT00894166|BG008|Baseline|Total|Total of all reporting groups
10967533|NCT00894166|FG000|Participant Flow|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967534|NCT00894166|FG001|Participant Flow|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
10967535|NCT00894166|FG002|Participant Flow|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
11244371|NCT02510664|BG002|Baseline|Provider|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments"
11244372|NCT02510664|BG003|Baseline|Total|Total of all reporting groups
10816862|NCT00004635|FG001|Participant Flow|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
10816863|NCT00004635|OG000|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
10816864|NCT00004635|OG001|Outcome|Placebo|Participants who received placebo in period 1 or 2
10816865|NCT00004635|OG001|Outcome|Placebo|Participants who received placebo in period 1 or 2.
10816866|NCT00004635|EG000|Reported Event|Thalidomide|
10816867|NCT00004635|EG001|Reported Event|Placebo|
10816868|NCT00004635|EG002|Reported Event|Goserelin (Zoladex)|
10816869|NCT00004635|EG003|Reported Event|Leuprolide|
10816870|NCT00004732|BG000|Baseline|Carotid-Artery Stenting|Patients Randomized to CAS
10816871|NCT00004732|BG001|Baseline|Carotid Endarterectomy|Patients Randomized to CEA
10816872|NCT00004732|BG002|Baseline|Total|Total of all reporting groups
10816873|NCT00004732|FG000|Participant Flow|Carotid-Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
10816874|NCT00004732|FG001|Participant Flow|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
10816875|NCT00004732|OG000|Outcome|Carotid-Artery Stenting|Patients Randomized to CAS
10816876|NCT00004732|OG001|Outcome|Carotid Endarterectomy|Patients Randomized to CEA
10816877|NCT00004732|OG000|Outcome|Carotid-Artery Stenting|Patients randomized to CAS
10816878|NCT00004732|OG001|Outcome|Carotid Endarterectomy|Patients randomized to CEA
10816879|NCT00004732|EG000|Reported Event|Carotid-Artery Stenting|Patients Randomized to CAS
10816880|NCT00004732|EG001|Reported Event|Carotid Endarterectomy|Patients Randomized to CEA
10816881|NCT00004859|BG000|Baseline|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
10816882|NCT00004859|BG001|Baseline|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
10816883|NCT00004859|BG002|Baseline|Total|Total of all reporting groups
10816884|NCT00004859|FG000|Participant Flow|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
10816885|NCT00004859|FG001|Participant Flow|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
10816886|NCT00004859|OG000|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
10816887|NCT00004859|OG001|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
10816888|NCT00004859|OG000|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
10816889|NCT00004859|OG001|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
10816890|NCT00004859|EG000|Reported Event|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
10816891|NCT00004859|EG001|Reported Event|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
10816892|NCT00004888|BG000|Baseline|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
10816893|NCT00004888|BG001|Baseline|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
10816894|NCT00004888|BG002|Baseline|Total|Total of all reporting groups
10816895|NCT00004888|FG000|Participant Flow|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
10816896|NCT00004888|FG001|Participant Flow|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
10816897|NCT00004888|OG000|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
10816898|NCT00004888|OG001|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
10816899|NCT00004888|EG000|Reported Event|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
10816900|NCT00004888|EG001|Reported Event|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
10816901|NCT00004978|BG000|Baseline|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
10816902|NCT00004978|BG001|Baseline|No rIL-2|Control group - no study-assigned medication
10816903|NCT00004978|BG002|Baseline|Total|Total of all reporting groups
10816904|NCT00004978|FG000|Participant Flow|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
10816905|NCT00004978|FG001|Participant Flow|No rIL-2|Control group - no study-assigned medication
10816906|NCT00004978|OG000|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
10816907|NCT00004978|OG001|Outcome|No rIL-2|Control group - no study-assigned medication
10816908|NCT00004978|EG000|Reported Event|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
10816909|NCT00004978|EG001|Reported Event|No rIL-2|Control group - no study-assigned medication
10816910|NCT00004980|BG000|Baseline|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
10816911|NCT00004980|BG001|Baseline|Placebo|Participants received sham stimulation
10816912|NCT00004980|BG002|Baseline|Total|Total of all reporting groups
10816913|NCT00004980|FG000|Participant Flow|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
10816914|NCT00004980|FG001|Participant Flow|Placebo|Participants received sham stimulation
10816915|NCT00004980|OG000|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
10816916|NCT00004980|OG001|Outcome|Placebo|Participants received sham stimulation
10816917|NCT00004980|EG000|Reported Event|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
10816918|NCT00004980|EG001|Reported Event|Placebo|Participants received sham stimulation
10816919|NCT00005047|BG000|Baseline|Arm I: M-VAC x 3|p53 positive, randomized to 3 cycles of adjuvant combination methotrexate, vinblastine, doxorubicin and cisplatin (MVAC)
10816920|NCT00005047|BG001|Baseline|Arm II: Observation|p53 positive, randomized to observation/no intervention
10816921|NCT00005047|BG002|Baseline|Arm III: Observation|p53 negative, assigned to observation/no intervention
10816922|NCT00005047|BG003|Baseline|Arm IV: Observation|p53 positive, refused random assignment, assigned to observation/no intervention
10816923|NCT00005047|BG004|Baseline|Total|Total of all reporting groups
10816924|NCT00005047|FG000|Participant Flow|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
10816925|NCT00005047|FG001|Participant Flow|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
10816926|NCT00005047|FG002|Participant Flow|Arm III: Observation|Patients with unaltered (-) p53
10816927|NCT00005047|FG003|Participant Flow|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
10816928|NCT00005047|OG000|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
10816929|NCT00005047|OG001|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
10816930|NCT00005047|OG000|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation~Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
10816931|NCT00005047|OG001|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
10816932|NCT00005047|EG000|Reported Event|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
10816933|NCT00005047|EG001|Reported Event|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
10816934|NCT00005047|EG002|Reported Event|Arm III: Observation|Patients with unaltered (-) p53
10816935|NCT00005047|EG003|Reported Event|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
10816936|NCT00005669|BG000|Baseline|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816937|NCT00005669|BG001|Baseline|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816938|NCT00005669|BG002|Baseline|Total|Total of all reporting groups
10816939|NCT00005669|FG000|Participant Flow|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816940|NCT00005669|FG001|Participant Flow|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816941|NCT00005669|OG000|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816942|NCT00005669|OG001|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816943|NCT00005669|EG000|Reported Event|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816944|NCT00005669|EG001|Reported Event|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
10816945|NCT00005803|BG000|Baseline|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
10816946|NCT00005803|FG000|Participant Flow|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
10816947|NCT00005803|OG000|Outcome|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
10816948|NCT00005803|OG000|Outcome|Chemosensitive Group|Patients who were CR or PR to most recent chemotherapy regimen.
10816949|NCT00005803|OG001|Outcome|Chemoresistant Group|Patients who were not CR or PR to most recent chemotherapy regimen.
10816950|NCT00005803|OG002|Outcome|Unknown Chemosensitivity Group|Patients who could not be evaluated for chemosensitivity.
10816951|NCT00005803|EG000|Reported Event|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
10816952|NCT00005879|BG000|Baseline|Placebo|"Placebo~Placebo: matched tablet dialy"
10816953|NCT00005879|BG001|Baseline|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
10816954|NCT00005879|BG002|Baseline|Total|Total of all reporting groups
10816955|NCT00005879|FG000|Participant Flow|Placebo|"Placebo~Placebo: matched tablet dialy"
10816956|NCT00005879|FG001|Participant Flow|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
10816957|NCT00005879|OG000|Outcome|Placebo|"Placebo~Placebo: matched tablet dialy"
10816958|NCT00005879|OG001|Outcome|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
10816959|NCT00005879|EG000|Reported Event|Placebo|"Placebo~Placebo: matched tablet dialy"
10816960|NCT00005879|EG001|Reported Event|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
10816961|NCT00005901|BG000|Baseline|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
10816962|NCT00005901|BG001|Baseline|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
10816963|NCT00005901|BG002|Baseline|Total|Total of all reporting groups
10816964|NCT00005901|FG000|Participant Flow|Active Comparator: 1|Receives treatment every 3 months
10816965|NCT00005901|FG001|Participant Flow|Active Comparator: 2|Receives treatment every 6 months.
10816966|NCT00005901|OG000|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
10816967|NCT00005901|OG001|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
10816968|NCT00005901|EG000|Reported Event|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
10816969|NCT00005901|EG001|Reported Event|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
10816970|NCT00005906|BG000|Baseline|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
10816971|NCT00005906|FG000|Participant Flow|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
10816972|NCT00005906|OG000|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
10816973|NCT00005906|EG000|Reported Event|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
10816974|NCT00005908|BG000|Baseline|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
10816975|NCT00005908|FG000|Participant Flow|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
10816976|NCT00005908|FG001|Participant Flow|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
10816977|NCT00005908|OG000|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
10816978|NCT00005908|OG001|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
10816979|NCT00005908|OG000|Outcome|Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
10816980|NCT00005908|OG000|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
10816981|NCT00005908|OG001|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
10816982|NCT00005908|OG000|Outcome|Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
10816983|NCT00005908|EG000|Reported Event|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
10816984|NCT00005937|BG000|Baseline|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Antithymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration, the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
10816985|NCT00005937|FG000|Participant Flow|MDS Subjects Treated With ATG & CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
10816986|NCT00005937|OG000|Outcome|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
10847279|NCT00282568|FG000|Participant Flow|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
10967536|NCT00894166|FG003|Participant Flow|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967537|NCT00894166|FG004|Participant Flow|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
10967538|NCT00894166|FG005|Participant Flow|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
10967539|NCT00894166|FG006|Participant Flow|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967540|NCT00894166|FG007|Participant Flow|Withdrew Prior to Randomization|"These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.~21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed."
10967541|NCT00894166|OG000|Outcome|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
10967542|NCT00894166|OG001|Outcome|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
10967543|NCT00894166|OG002|Outcome|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
10967544|NCT00894166|OG003|Outcome|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
11206526|NCT02236559|OG000|Outcome|Noninvasive Positive Pressure Ventilation|Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
10967545|NCT00894166|OG004|Outcome|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
10967546|NCT00894166|OG005|Outcome|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
10967547|NCT00894166|OG006|Outcome|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
10967548|NCT00894166|OG000|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967549|NCT00894166|OG001|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
10967550|NCT00894166|OG002|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
11092529|NCT01540474|FG002|Participant Flow|Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092530|NCT01540474|FG003|Participant Flow|Control Group|Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
11092531|NCT01540474|OG000|Outcome|Group 1: 10 ug FMP012 With 2 ug GLA-SE|"Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant"
11092532|NCT01540474|OG001|Outcome|Group 2: 10 ug FMP012 With 5 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092533|NCT01540474|OG002|Outcome|Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092534|NCT01540474|OG003|Outcome|Control Group|Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
11092535|NCT01540474|OG002|Outcome|Group 3a: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~50 ug FMP012 with 5 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092536|NCT01540474|EG000|Reported Event|Group 1: 10 ug FMP012 With 2 ug GLA-SE|"Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant"
11092537|NCT01540474|EG001|Reported Event|Group 2: 10 ug FMP012 With 5 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092538|NCT01540474|EG002|Reported Event|Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE|"Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant~50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant"
11092539|NCT01540474|EG003|Reported Event|Control Group|Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
11092540|NCT01540487|BG000|Baseline|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
11092541|NCT01540487|BG001|Baseline|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
11092542|NCT01540487|BG002|Baseline|Total|Total of all reporting groups
11092543|NCT01540487|FG000|Participant Flow|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
11092544|NCT01540487|FG001|Participant Flow|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
11092545|NCT01540487|OG000|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
11092546|NCT01540487|OG001|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
11092547|NCT01540487|OG002|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
11092548|NCT01540487|OG003|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
11092549|NCT01540487|EG000|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
11092550|NCT01540487|EG001|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
11092551|NCT01540487|EG002|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
11092552|NCT01540487|EG003|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
10967551|NCT00894166|OG003|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967552|NCT00894166|OG004|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
10967553|NCT00894166|OG005|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
10967554|NCT00894166|OG006|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
10967555|NCT00894166|EG000|Reported Event|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
10967556|NCT00894166|EG001|Reported Event|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
10967557|NCT00894166|EG002|Reported Event|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
10967558|NCT00894166|EG003|Reported Event|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
10967559|NCT00894166|EG004|Reported Event|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
10967560|NCT00894166|EG005|Reported Event|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
10967561|NCT00894166|EG006|Reported Event|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
10967562|NCT00894322|BG000|Baseline|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
10967563|NCT00894322|BG001|Baseline|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
10967564|NCT00894322|BG002|Baseline|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967565|NCT00894322|BG003|Baseline|Total|Total of all reporting groups
10967566|NCT00894322|FG000|Participant Flow|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
10967567|NCT00894322|FG001|Participant Flow|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
10967568|NCT00894322|FG002|Participant Flow|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967569|NCT00894322|OG000|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
10816987|NCT00005937|EG000|Reported Event|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
10816988|NCT00005947|BG000|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
10816989|NCT00005947|BG001|Baseline|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
10816990|NCT00005947|BG002|Baseline|Total|Total of all reporting groups
10816991|NCT00005947|FG000|Participant Flow|Sipuleucel-T|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
10816992|NCT00005947|FG001|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
10816993|NCT00005947|OG000|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T.
10816994|NCT00005947|OG001|Outcome|Placebo|All subjects randomized to receive placebo
10816995|NCT00005947|OG000|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
10816996|NCT00005947|OG001|Outcome|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
10816997|NCT00005947|EG000|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
10816998|NCT00005947|EG001|Reported Event|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
10816999|NCT00005957|BG000|Baseline|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
10817000|NCT00005957|BG001|Baseline|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
10817001|NCT00005957|BG002|Baseline|Total|Total of all reporting groups
10817002|NCT00005957|FG000|Participant Flow|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
10817003|NCT00005957|FG001|Participant Flow|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
10817004|NCT00005957|OG000|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
10817005|NCT00005957|OG001|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
10817006|NCT00005957|EG000|Reported Event|Standard Breast Irradiation|"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.~Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment."
10817007|NCT00005957|EG001|Reported Event|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.~Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment."
10817008|NCT00006011|BG000|Baseline|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
10817009|NCT00006011|BG001|Baseline|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
10817010|NCT00006011|BG002|Baseline|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
10817011|NCT00006011|BG003|Baseline|Total|Total of all reporting groups
10967570|NCT00894322|OG001|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967571|NCT00894322|OG002|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967572|NCT00894322|OG000|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967573|NCT00894322|OG001|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967574|NCT00894322|EG000|Reported Event|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
10967575|NCT00894322|EG001|Reported Event|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967576|NCT00894322|EG002|Reported Event|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
10967577|NCT00894361|BG000|Baseline|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
10967578|NCT00894361|BG001|Baseline|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
10967579|NCT00894361|BG002|Baseline|Total|Total of all reporting groups
10967580|NCT00894361|FG000|Participant Flow|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
10967581|NCT00894361|FG001|Participant Flow|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
10967582|NCT00894361|OG000|Outcome|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
10967583|NCT00894361|OG001|Outcome|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
10967584|NCT00894361|OG000|Outcome|Rotating-platform Design TKA|"patients who were randomized to receive the rotating platform mobile-bearing TKA design~TKA surgery with the rotating platform mobile-bearing knee design: Depuy Sigma RP rotating platform design"
10967585|NCT00894361|OG001|Outcome|All-polyethylene Tibia Design TKA|"patients who were randomized to receive the all-polyethylene tibial component design~TKA surgery with the all-polyethylene tibia knee design: Depuy Sigma fixed-bearing design with all-polyethylene tibia"
10967586|NCT00894361|EG000|Reported Event|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
10967587|NCT00894361|EG001|Reported Event|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
10967588|NCT00894387|BG000|Baseline|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
10967589|NCT00894387|BG001|Baseline|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
10967590|NCT00894387|BG002|Baseline|Total|Total of all reporting groups
10967591|NCT00894387|FG000|Participant Flow|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
10967592|NCT00894387|FG001|Participant Flow|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
10967593|NCT00894387|OG000|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
10967594|NCT00894387|OG001|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
10967595|NCT00894387|EG000|Reported Event|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
10967596|NCT00894387|EG001|Reported Event|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
10967597|NCT00894413|BG000|Baseline|Placebo|Placebo Pill: Placebo
10967598|NCT00894413|BG001|Baseline|Tadalafil|Tadalafil: 20 mg once daily for 10 - 14 days
10817012|NCT00006011|FG000|Participant Flow|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
10817013|NCT00006011|FG001|Participant Flow|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
10817014|NCT00006011|FG002|Participant Flow|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
10817015|NCT00006011|OG000|Outcome|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
10817016|NCT00006011|OG001|Outcome|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
10817017|NCT00006011|EG000|Reported Event|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
10817018|NCT00006011|EG001|Reported Event|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
10817019|NCT00006046|BG000|Baseline|Hu3S193 10 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817020|NCT00006046|BG001|Baseline|Hu3S193 25 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817021|NCT00006046|BG002|Baseline|Hu3S193 50 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817022|NCT00006046|BG003|Baseline|Hu3S193 100 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817023|NCT00006046|BG004|Baseline|Hu3S193 200 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817024|NCT00006046|BG005|Baseline|Total|Total of all reporting groups
10817025|NCT00006046|FG000|Participant Flow|Hu3S193 10 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817026|NCT00006046|FG001|Participant Flow|Hu3S193 25 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817027|NCT00006046|FG002|Participant Flow|Hu3S193 50 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817028|NCT00006046|FG003|Participant Flow|Hu3S193 100 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817029|NCT00006046|FG004|Participant Flow|Hu3S193 200 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817030|NCT00006046|OG000|Outcome|Hu3S193 10 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817031|NCT00006046|OG001|Outcome|Hu3S193 25 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817032|NCT00006046|OG002|Outcome|Hu3S193 50 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817033|NCT00006046|OG003|Outcome|Hu3S193 100 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10967599|NCT00894413|BG002|Baseline|Total|Total of all reporting groups
10967600|NCT00894413|FG000|Participant Flow|Placebo|Placebo Pill: Placebo
10967601|NCT00894413|FG001|Participant Flow|Tadalafil|Tadalafil: 20 mg once daily for 10 - 14 days
10967602|NCT00894413|OG000|Outcome|Placebo|Placebo Pill: Placebo
10967603|NCT00894413|OG001|Outcome|Tadalafil|Tadalafil: 20 mg once daily for 10 - 14 days
10967604|NCT00894413|EG000|Reported Event|Placebo|Placebo Pill: Placebo
10967605|NCT00894413|EG001|Reported Event|Tadalafil|Tadalafil: 20 mg once daily for 10 - 14 days
10967606|NCT00894465|BG000|Baseline|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
10967607|NCT00894465|BG001|Baseline|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
10967608|NCT00894465|BG002|Baseline|Total|Total of all reporting groups
10967609|NCT00894465|FG000|Participant Flow|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
10967610|NCT00894465|FG001|Participant Flow|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
10967611|NCT00894465|OG000|Outcome|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
10967612|NCT00894465|OG001|Outcome|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
10967613|NCT00894465|OG000|Outcome|Versed|Parents of patients who were given oral midazolam prior to undergoing the VCUG.
10967614|NCT00894465|OG001|Outcome|Placebo|Parents of patients who were given oral placebo prior to undergoing the VCUG.
10967615|NCT00894465|EG000|Reported Event|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
10967616|NCT00894465|EG001|Reported Event|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
10967617|NCT00894504|BG000|Baseline|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
10967618|NCT00894504|FG000|Participant Flow|Panitumumab/Gemcitabine/Carboplatin|"Treatment cycles are repeated every 14 days (2 weeks)~Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.~Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle~Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle"
11206527|NCT02236559|OG001|Outcome|High Velocity Nasal Insufflation|Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
10967619|NCT00894504|OG000|Outcome|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
10967620|NCT00894504|OG000|Outcome|Panitumumab/Gemcitabine/Carboplatin|Systemic therapy
10967621|NCT00894504|OG000|Outcome|Arm/Group 1|
10967622|NCT00894504|OG000|Outcome|EGFR Normal|
10967623|NCT00894504|OG001|Outcome|EGFR Amplified|
10967624|NCT00894504|OG002|Outcome|p53 Normal|
10967625|NCT00894504|OG003|Outcome|p53 Loss|
10967626|NCT00894504|OG004|Outcome|PTEN Normal|
10967627|NCT00894504|OG005|Outcome|PTEN Loss|
10967628|NCT00894504|OG006|Outcome|PIK3CA No Mutation|
10967629|NCT00894504|OG007|Outcome|PIK3CA Mutation(s)|
10967630|NCT00894504|EG000|Reported Event|Panitumumab/Gemcitabine/Carboplatin|
10967631|NCT00894517|BG000|Baseline|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
10967632|NCT00894517|BG001|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
10967633|NCT00894517|BG002|Baseline|Total|Total of all reporting groups
10967634|NCT00894517|FG000|Participant Flow|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
10967635|NCT00894517|FG001|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
10967636|NCT00894517|OG000|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
10967637|NCT00894517|OG001|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
10967638|NCT00894517|EG000|Reported Event|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
10967639|NCT00894517|EG001|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
11286177|NCT02885025|BG001|Baseline|BSE + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
10847771|NCT00286091|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847772|NCT00286091|BG001|Baseline|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847773|NCT00286091|BG002|Baseline|Total|Total of all reporting groups
10847774|NCT00286091|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847775|NCT00286091|FG001|Participant Flow|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847776|NCT00286091|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847777|NCT00286091|OG001|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847778|NCT00286091|EG000|Reported Event|DB: Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
10847779|NCT00286091|EG001|Reported Event|DB: Denosumab 120 mg Q4W|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
10847780|NCT00286091|EG002|Reported Event|OLE: Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
10847781|NCT00286091|EG003|Reported Event|OLE: Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
10847782|NCT00286156|BG000|Baseline|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
10847783|NCT00286156|BG001|Baseline|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
10847784|NCT00286156|BG002|Baseline|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
10847785|NCT00286156|BG003|Baseline|Total|Total of all reporting groups
10847786|NCT00286156|FG000|Participant Flow|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
10847787|NCT00286156|FG001|Participant Flow|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
10847788|NCT00286156|FG002|Participant Flow|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
10847789|NCT00286156|OG000|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
10847790|NCT00286156|OG001|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
10847791|NCT00286156|OG002|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
10847792|NCT00286156|EG000|Reported Event|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
10847793|NCT00286156|EG001|Reported Event|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
10847794|NCT00286156|EG002|Reported Event|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
10847795|NCT00286182|BG000|Baseline|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
10847796|NCT00286182|BG001|Baseline|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
10847797|NCT00286182|BG002|Baseline|Total|Total of all reporting groups
10848183|NCT00289016|OG000|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
10817034|NCT00006046|OG004|Outcome|Hu3S193 200 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817035|NCT00006046|EG000|Reported Event|Hu3S193 10 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817036|NCT00006046|EG001|Reported Event|Hu3S193 25 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817037|NCT00006046|EG002|Reported Event|Hu3S193 50 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817038|NCT00006046|EG003|Reported Event|Hu3S193 100 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817039|NCT00006046|EG004|Reported Event|Hu3S193 200 mg/m2|Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
10817040|NCT00006099|BG000|Baseline|Intraperitoneal (IP) Infusion of 111In-hu3S193|"Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 mCi of 111In.~Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline."
10817041|NCT00006099|BG001|Baseline|Intravenous Infusion of 111In-hu3S193|Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 mCi of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
10817042|NCT00006099|BG002|Baseline|Total|Total of all reporting groups
10817043|NCT00006099|FG000|Participant Flow|Intraperitoneal (IP) Infusion of 111In-hu3S193|"Hu3S193 was administered intraperitoneally (IP) at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In.~Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline."
10817044|NCT00006099|FG001|Participant Flow|Intravenous Infusion of 111In-hu3S193|Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
10817045|NCT00006099|OG000|Outcome|Intraperitoneal (IP) Infusion of 111In-hu3S193|"Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 mCi of 111In.~Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline."
10817046|NCT00006099|OG001|Outcome|Intravenous Infusion of 111In-hu3S193|Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 mCi of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
10817047|NCT00006099|EG000|Reported Event|Intraperitoneal (IP) Infusion of 111In-hu3S193|"Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 mCi of 111In.~Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline."
10817048|NCT00006099|EG001|Reported Event|Intravenous Infusion of 111In-hu3S193|Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 mCi of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
10817049|NCT00006101|BG000|Baseline|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
10817050|NCT00006101|BG001|Baseline|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
10817051|NCT00006101|BG002|Baseline|Total|Total of all reporting groups
10817052|NCT00006101|FG000|Participant Flow|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of eflornithine (Difluoromethylornithine) per day for 12 months"
10817053|NCT00006101|FG001|Participant Flow|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
10817054|NCT00006101|OG000|Outcome|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
10817055|NCT00006101|OG001|Outcome|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
10817056|NCT00006101|EG000|Reported Event|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
10817057|NCT00006101|EG001|Reported Event|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
10817058|NCT00006110|BG000|Baseline|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
10817059|NCT00006110|BG001|Baseline|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional Adriamycin/Cytoxan (4AC) followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
10817060|NCT00006110|BG002|Baseline|Total|Total of all reporting groups
10817061|NCT00006110|FG000|Participant Flow|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
10817062|NCT00006110|FG001|Participant Flow|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
10817063|NCT00006110|OG000|Outcome|Herceptin Regimen After AC|Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).
10817064|NCT00006110|OG001|Outcome|Herceptin Regimen After TP|Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.
10817065|NCT00006110|OG002|Outcome|Herceptin Regimen at 1.5 Years|Patients in the adjuvant and neoadjuvant groups.
10817066|NCT00006110|OG003|Outcome|Herceptin Regimen|Worst per-patient toxicity: represents the number of patients who had cardiac toxicity at any time during the study regardless of subsequent recovery of function.
10817067|NCT00006110|OG000|Outcome|Patients Treated Neoadjuvantly With AC-TP|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin followed by surgery followed by radiation or no radiation followed by herceptin.
10817068|NCT00006110|OG001|Outcome|Patients Treated With AC-P (Without Herceptin)|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
10817069|NCT00006110|OG000|Outcome|Experimental: Herceptin With or Without Radiation|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin in both the neoadjuvant and the adjuvant groups.
10817070|NCT00006110|OG001|Outcome|Experimental: Non-Herceptin With or Without Radiation|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
10817071|NCT00006110|EG000|Reported Event|Chemotherapy + Herceptin|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
10817072|NCT00006110|EG001|Reported Event|Control: Non-Herceptin|Patients with high-risk HER-2 non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
10817073|NCT00006151|BG000|Baseline|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
10817074|NCT00006151|BG001|Baseline|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
10817075|NCT00006151|BG002|Baseline|Total|Total of all reporting groups
10817076|NCT00006151|FG000|Participant Flow|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
10817077|NCT00006151|FG001|Participant Flow|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
10817078|NCT00006151|OG000|Outcome|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
10817079|NCT00006151|OG001|Outcome|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
10817080|NCT00006151|EG000|Reported Event|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
10817081|NCT00006151|EG001|Reported Event|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
10817082|NCT00006156|BG000|Baseline|Drug - FSH|
10817083|NCT00006156|BG001|Baseline|Control|
10817084|NCT00006156|BG002|Baseline|Total|Total of all reporting groups
10817085|NCT00006156|FG000|Participant Flow|Drug - FSH|
10817086|NCT00006156|FG001|Participant Flow|Control|
10817087|NCT00006156|OG000|Outcome|Drug - FSH|
10817088|NCT00006156|OG001|Outcome|Control|
10817089|NCT00006156|EG000|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
10817090|NCT00006164|BG000|Baseline|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
10817091|NCT00006164|BG001|Baseline|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
10817092|NCT00006164|BG002|Baseline|Total|Total of all reporting groups
10817093|NCT00006164|FG000|Participant Flow|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
10817094|NCT00006164|FG001|Participant Flow|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
10817095|NCT00006164|OG000|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
10817096|NCT00006164|OG001|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
10967640|NCT00894543|BG000|Baseline|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
10967641|NCT00894543|BG001|Baseline|Placebo|Inactive pill
10967642|NCT00894543|BG002|Baseline|Total|Total of all reporting groups
10967643|NCT00894543|FG000|Participant Flow|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
10967644|NCT00894543|FG001|Participant Flow|Placebo|Inactive pill
10967645|NCT00894543|OG000|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
10967646|NCT00894543|OG001|Outcome|Placebo|Inactive pill
10967647|NCT00894543|EG000|Reported Event|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
10967648|NCT00894543|EG001|Reported Event|Placebo|Inactive pill
10967649|NCT00894647|BG000|Baseline|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
10967650|NCT00894647|BG001|Baseline|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
10967651|NCT00894647|BG002|Baseline|Total|Total of all reporting groups
10967652|NCT00894647|FG000|Participant Flow|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
10967653|NCT00894647|FG001|Participant Flow|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
10967654|NCT00894647|OG000|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
10967655|NCT00894647|OG001|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
10967656|NCT00894647|EG000|Reported Event|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
10967657|NCT00894647|EG001|Reported Event|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
10967658|NCT00894686|BG000|Baseline|FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL|Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study.
10967659|NCT00894686|FG000|Participant Flow|FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL|Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study.
10967660|NCT00894686|OG000|Outcome|FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL|Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study.
10967661|NCT00894686|EG000|Reported Event|FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL|Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study.
10967662|NCT00894699|BG000|Baseline|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
10967663|NCT00894699|BG001|Baseline|Placebo|Single dose of Placebo
10967664|NCT00894699|BG002|Baseline|Total|Total of all reporting groups
10967665|NCT00894699|FG000|Participant Flow|Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
10967666|NCT00894699|FG001|Participant Flow|Single Dose of Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
10967667|NCT00894699|OG000|Outcome|Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
10967668|NCT00894699|OG001|Outcome|Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
10967669|NCT00894699|EG000|Reported Event|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
10967670|NCT00894699|EG001|Reported Event|Placebo|Single dose of Placebo
11206528|NCT02236559|EG000|Reported Event|Noninvasive Positive Pressure Ventilation|Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
11244373|NCT02510664|FG000|Participant Flow|Adolescent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10817097|NCT00006164|EG000|Reported Event|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
10817098|NCT00006164|EG001|Reported Event|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
10817099|NCT00006170|BG000|Baseline|WC+B|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
10817100|NCT00006170|BG001|Baseline|WC+P|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
10817101|NCT00006170|BG002|Baseline|SS+B|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
10817102|NCT00006170|BG003|Baseline|SS+P|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
10817103|NCT00006170|BG004|Baseline|Total|Total of all reporting groups
10817104|NCT00006170|FG000|Participant Flow|Weight Concerns + Bupropion (WC+B)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
10817105|NCT00006170|FG001|Participant Flow|Weight Concerns + Placebo (WC+P)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
10817106|NCT00006170|FG002|Participant Flow|Social Support + Bupropion (SS+B)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
10817107|NCT00006170|FG003|Participant Flow|Social Support + Placebo (SS+P)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
10817108|NCT00006170|OG000|Outcome|WC+B|
10817109|NCT00006170|OG001|Outcome|WC+P|
10817110|NCT00006170|OG002|Outcome|SS+B|
10817111|NCT00006170|OG003|Outcome|SS+P|
10817112|NCT00006170|EG000|Reported Event|WC+B|
10817113|NCT00006170|EG001|Reported Event|WC+P|
10967671|NCT00894738|BG000|Baseline|Antipsychotic-Treated|Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
10817114|NCT00006170|EG002|Reported Event|SS+B|
10817115|NCT00006170|EG003|Reported Event|SS+P|
10822021|NCT00073918|EG000|Reported Event|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
10822022|NCT00073957|BG000|Baseline|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
10822023|NCT00073957|FG000|Participant Flow|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
10822024|NCT00073957|OG000|Outcome|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
10822025|NCT00073957|OG000|Outcome|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Y 90 Ibritumomab Tiuxetan and Rituximab
10822026|NCT00073957|OG000|Outcome|Yttrium Y 90 Ibritumomab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
10822027|NCT00073957|EG000|Reported Event|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
10822028|NCT00073983|BG000|Baseline|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
10822029|NCT00073983|FG000|Participant Flow|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
10822030|NCT00073983|OG000|Outcome|Ewing's Sarcoma|Combination chemotherapy
10822031|NCT00073983|OG001|Outcome|Osteosarcoma|Combination Chemotherapy
10822032|NCT00073983|OG002|Outcome|Chondrosarcoma|Combination chemotherapy
10967672|NCT00894738|BG001|Baseline|Healthy Control|Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
10967673|NCT00894738|BG002|Baseline|Total|Total of all reporting groups
10967674|NCT00894738|FG000|Participant Flow|Antipsychotic-Treated|Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
10967675|NCT00894738|FG001|Participant Flow|Healthy Control|Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
10967676|NCT00894738|OG000|Outcome|Antipsychotic-Treated|Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
10967677|NCT00894738|OG001|Outcome|Healthy Control|Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
10967678|NCT00894738|EG000|Reported Event|Antipsychotic-Treated|Children with psychiatric diagnoses who are currently treated with antipsychotic medications.
10967679|NCT00894738|EG001|Reported Event|Healthy Control|Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.
10967680|NCT00894803|BG000|Baseline|Rt-PA Only|rt-PA (0.9 mg/kg)
10967681|NCT00894803|BG001|Baseline|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
10967682|NCT00894803|BG002|Baseline|Total|Total of all reporting groups
10967683|NCT00894803|FG000|Participant Flow|Rt-PA and Eptifibatide|recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
10967684|NCT00894803|FG001|Participant Flow|Rt-PA Only|recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)
10967685|NCT00894803|OG000|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
10967686|NCT00894803|OG001|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
10967687|NCT00894803|EG000|Reported Event|Rt-PA Only|rt-PA (0.9 mg/kg)
10967688|NCT00894803|EG001|Reported Event|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
10967689|NCT00894933|BG000|Baseline|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
10967690|NCT00894933|FG000|Participant Flow|Continuum|"Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.~CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy."
10967691|NCT00894933|OG000|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
10967692|NCT00894933|EG000|Reported Event|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
10967693|NCT00895011|BG000|Baseline|Placebo|
10967694|NCT00895011|BG001|Baseline|Avanafil 100 mg|
10967695|NCT00895011|BG002|Baseline|Avanafil 200 mg|
10967696|NCT00895011|BG003|Baseline|Total|Total of all reporting groups
10967697|NCT00895011|FG000|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10967698|NCT00895011|FG001|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10967699|NCT00895011|FG002|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10967700|NCT00895011|OG000|Outcome|Placebo|placeb 30 minutes orally prior to initiation of sexual activity
10967701|NCT00895011|OG001|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
10967702|NCT00895011|OG002|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
10967703|NCT00895011|OG000|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
10967704|NCT00895011|EG000|Reported Event|Placebo|
10967705|NCT00895011|EG001|Reported Event|Avanafil 100 mg|
10967706|NCT00895011|EG002|Reported Event|Avanafil 200 mg|
10967707|NCT00895037|BG000|Baseline|ReFacto AF: On Demand Treatment|Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
10967708|NCT00895037|BG001|Baseline|ReFacto AF: Prophylaxis Treatment|Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967709|NCT00895037|BG002|Baseline|ReFacto AF: Intermediate Prophylaxis Treatment|Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967710|NCT00895037|BG003|Baseline|Total|Total of all reporting groups
10967711|NCT00895037|FG000|Participant Flow|ReFacto AF: On Demand Treatment|Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
10967712|NCT00895037|FG001|Participant Flow|ReFacto AF: Prophylaxis Treatment|Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10817116|NCT04323800|BG000|Baseline|High Titer Anti-SARS-CoV-2 Plasma|"Participants with High titer anti-SARS-CoV-2 plasma.~Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320"
10817117|NCT04323800|BG001|Baseline|SARS-CoV-2 Non-immune Plasma|"Participants with SARS-CoV-2 non-immune plasma.~SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019"
10817118|NCT04323800|BG002|Baseline|Total|Total of all reporting groups
10817119|NCT04323800|FG000|Participant Flow|High Titer Anti-SARS-CoV-2 Plasma|"Participants with High titer anti-SARS-CoV-2 plasma.~Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320"
10817120|NCT04323800|FG001|Participant Flow|SARS-CoV-2 Non-immune Plasma|"Participants with SARS-CoV-2 non-immune plasma.~SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019"
10817121|NCT04323800|OG000|Outcome|High Titer Anti-SARS-CoV-2 Plasma|"Participants with High titer anti-SARS-CoV-2 plasma.~Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320"
10817122|NCT04323800|OG001|Outcome|SARS-CoV-2 Non-immune Plasma|"Participants with SARS-CoV-2 non-immune plasma.~SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019"
10817123|NCT04323800|EG000|Reported Event|High Titer Anti-SARS-CoV-2 Plasma|"Participants with High titer anti-SARS-CoV-2 plasma.~Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320"
10817124|NCT04323800|EG001|Reported Event|SARS-CoV-2 Non-immune Plasma|"Participants with SARS-CoV-2 non-immune plasma.~SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019"
10817125|NCT04279925|BG000|Baseline|Locally-made Miniplate and Screw|Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.
10817126|NCT04279925|BG001|Baseline|Imported Miniplate and Screw|Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
10817127|NCT04279925|BG002|Baseline|Total|Total of all reporting groups
10817128|NCT04279925|FG000|Participant Flow|Locally-made Miniplate and Screw|Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia
10817129|NCT04279925|FG001|Participant Flow|Imported Miniplate and Screw|Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
10817130|NCT04279925|OG000|Outcome|Locally-made Miniplate and Screw|Fracture lines in this group underwent open reduction internal fixation (ORIF) procedure which consists of realignment of the bone achieved from surgical mean and stabilization of the bone fragments by using locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. The plate used in the study is a straight plate with 4 and 5 holes with the dimension of 17mm long, 4 mm wide and 0.56 mm thick.
10817131|NCT04279925|OG001|Outcome|Imported Miniplate and Screw|Fracture lines in this group underwent open reduction internal fixation (ORIF) procedure which consists of realignment of the bone achieved from surgical mean and stabilization of the bone fragments by using Biomet® miniplate 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. The particular plate used in the study is a straight plate with 4 holes, 17mm length and 0.6mm thick, coded 01-7047 in the catalog. Biomet® screw 1.5 utilized in this study is also produced by Biomet, included in the Lorenz® Plating System Midface. The dimension of the screw is 4mm length, 1.5 mm diameter, and coded 91-6104 1.5 mm X-Drive Self drilling screws.
10817132|NCT04279925|EG000|Reported Event|Locally-made Miniplate and Screw|Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.
10817133|NCT04279925|EG001|Reported Event|Imported Miniplate and Screw|Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
10817134|NCT04110145|BG000|Baseline|Cohort 1 (Linaclotide 18 μg)|Linaclotide,18 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817135|NCT04110145|BG001|Baseline|Cohort 2 (Linaclotide 36 μg)|Linaclotide, 36 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817136|NCT04110145|BG002|Baseline|Cohort 3 (Linaclotide 72 μg)|Linaclotide, 72 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817137|NCT04110145|BG003|Baseline|Final Cohort (Linaclotide 72 μg)|Linaclotide at the highest dose tested/determined to be safe (72 μg), capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817138|NCT04110145|BG004|Baseline|Placebo Pooled|Matching placebo once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period pooled from Cohorts 1, 2, 3, and Final Cohort.
10817139|NCT04110145|BG005|Baseline|Total|Total of all reporting groups
10817140|NCT04110145|FG000|Participant Flow|Cohort 1 (Linaclotide 18 μg)|Linaclotide 18 microgram (μg), capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817141|NCT04110145|FG001|Participant Flow|Cohort 2 (Linaclotide 36 μg)|Linaclotide 36 μg, capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817142|NCT04110145|FG002|Participant Flow|Cohort 3 (Linaclotide 72 μg)|Linaclotide 72 μg, capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817143|NCT04110145|FG003|Participant Flow|Final Cohort (Linaclotide 72 μg)|Linaclotide at the highest dose tested/determined to be safe (72 μg), capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817144|NCT04110145|FG004|Participant Flow|Placebo Pooled|Matching placebo, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period pooled from Cohorts 1, 2, 3, and Final Cohort.
10817145|NCT04110145|OG000|Outcome|Cohort 1 (Linaclotide 18 μg)|Linaclotide,18 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817146|NCT04110145|OG001|Outcome|Cohort 2 (Linaclotide 36 μg)|Linaclotide, 36 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817147|NCT04110145|OG002|Outcome|Cohort 3 (Linaclotide 72 μg)|Linaclotide, 72 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817148|NCT04110145|OG003|Outcome|Final Cohort (Linaclotide 72 μg)|Linaclotide at the highest dose tested/determined to be safe (72 μg), capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817149|NCT04110145|OG004|Outcome|Placebo Pooled|Matching placebo once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period pooled from Cohorts 1, 2, 3, and Final Cohort.
10817150|NCT04110145|EG000|Reported Event|Cohort 1 (Linaclotide 18 μg)|Linaclotide,18 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817151|NCT04110145|EG001|Reported Event|Cohort 2 (Linaclotide 36 μg)|Linaclotide, 36 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817152|NCT04110145|EG002|Reported Event|Cohort 3 (Linaclotide 72 μg)|Linaclotide, 72 μg, capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817153|NCT04110145|EG003|Reported Event|Final Cohort (Linaclotide 72 μg)|Linaclotide at the highest dose tested/determined to be safe (72 μg), capsules, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
10817154|NCT04110145|EG004|Reported Event|Placebo Pooled|Matching placebo once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period pooled from Cohorts 1, 2, 3, and Final Cohort.
10817155|NCT03986866|BG000|Baseline|No Video|Patients are not shown the informational video on the safe usage of opioids.
10817156|NCT03986866|BG001|Baseline|Video|"Patients are shown an informational video on the safe usage of opioids.~Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown."
10817157|NCT03986866|BG002|Baseline|Total|Total of all reporting groups
10817158|NCT03986866|FG000|Participant Flow|No Video|Patients are not shown the informational video on the safe usage of opioids.
10817159|NCT03986866|FG001|Participant Flow|Video|"Patients are shown an informational video on the safe usage of opioids.~Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown."
10817160|NCT03986866|OG000|Outcome|No Video|Patients are not shown the informational video on the safe usage of opioids.
10817161|NCT03986866|OG001|Outcome|Video|"Patients are shown an informational video on the safe usage of opioids.~Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown."
10817162|NCT03986866|EG000|Reported Event|No Video|Patients are not shown the informational video on the safe usage of opioids.
10817163|NCT03986866|EG001|Reported Event|Video|"Patients are shown an informational video on the safe usage of opioids.~Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown."
10817164|NCT03636269|BG000|Baseline|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817165|NCT03636269|BG001|Baseline|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV placebo administered three times/week"
10817166|NCT03636269|BG002|Baseline|Total|Total of all reporting groups
10817167|NCT03636269|FG000|Participant Flow|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817168|NCT03636269|FG001|Participant Flow|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV placebo administered three times/week"
10817169|NCT03636269|FG002|Participant Flow|Open-label CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817170|NCT03636269|OG000|Outcome|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817171|NCT03636269|OG001|Outcome|Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV placebo administered three times/week"
10817172|NCT03636269|OG000|Outcome|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817173|NCT03636269|OG001|Outcome|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV placebo administered three times/week"
10817174|NCT03636269|EG000|Reported Event|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10817175|NCT03636269|EG001|Reported Event|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV placebo administered three times/week"
10817176|NCT03636269|EG002|Reported Event|Open-label CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week"
10822033|NCT00073983|EG000|Reported Event|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
10822034|NCT00074035|BG000|Baseline|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
10822035|NCT00074035|FG000|Participant Flow|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
10822036|NCT00074035|OG000|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
11206529|NCT02236559|EG001|Reported Event|High Velocity Nasal Insufflation|Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
11206530|NCT02236598|BG000|Baseline|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
11206531|NCT02236598|BG001|Baseline|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
11206532|NCT02236598|BG002|Baseline|Total|Total of all reporting groups
11206533|NCT02236598|FG000|Participant Flow|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
11206534|NCT02236598|FG001|Participant Flow|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
10822037|NCT00074035|EG000|Reported Event|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
10817177|NCT03527264|BG000|Baseline|Cohort 1A|"Nivolumab during Chemo/RT with whole pelvic RT~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817178|NCT03527264|BG001|Baseline|Cohort 1B|"Nivolumab during Chemo/RT with extended field~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817179|NCT03527264|BG002|Baseline|Cohort 2|"Chemoradiation followed by Nivolumab Maintenance~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years"
10817180|NCT03527264|BG003|Baseline|Cohort 3|"Nivolumab during chemoradiation and then as maintenance~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.~Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years"
10817181|NCT03527264|BG004|Baseline|Total|Total of all reporting groups
10817182|NCT03527264|FG000|Participant Flow|Cohort 1A|"Nivolumab during Chemo/RT with whole pelvic RT~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817183|NCT03527264|FG001|Participant Flow|Cohort 1B|"Nivolumab during Chemo/RT with extended field~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817184|NCT03527264|FG002|Participant Flow|Cohort 2|"Chemoradiation followed by Nivolumab Maintenance~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years"
10817185|NCT03527264|FG003|Participant Flow|Cohort 3|"Nivolumab during chemoradiation and then as maintenance~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.~Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years"
10817186|NCT03527264|OG000|Outcome|Cohort 1A|"Nivolumab during Chemo/RT with whole pelvic RT~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817187|NCT03527264|OG001|Outcome|Cohort 1B|"Nivolumab during Chemo/RT with extended field~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817188|NCT03527264|EG000|Reported Event|Cohort 1A|"Nivolumab during Chemo/RT with whole pelvic RT~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817189|NCT03527264|EG001|Reported Event|Cohort 1B|"Nivolumab during Chemo/RT with extended field~Nivolumab induction: 2 doses Nivolumab 240mg IV~Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.~Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx~Whole pelvic or extended field~Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation."
10817190|NCT03447314|BG000|Baseline|Part 1a: 50ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817191|NCT03447314|BG001|Baseline|Part 1a: 100ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10822038|NCT00074152|BG000|Baseline|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
10967713|NCT00895037|FG002|Participant Flow|ReFacto AF: Intermediate Prophylaxis Treatment|Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967714|NCT00895037|OG000|Outcome|ReFacto AF: On Demand Treatment|Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
10967715|NCT00895037|OG001|Outcome|ReFacto AF: Prophylaxis Treatment|Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967716|NCT00895037|OG002|Outcome|ReFacto AF: Intermediate Prophylaxis Treatment|Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967717|NCT00895037|EG000|Reported Event|ReFacto AF: On Demand Treatment|Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
10967718|NCT00895037|EG001|Reported Event|ReFacto AF: Prophylaxis Treatment|Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967719|NCT00895037|EG002|Reported Event|ReFacto AF: Intermediate Prophylaxis Treatment|Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
10967720|NCT00895154|BG000|Baseline|General Tutoring Group|"Participants will receive general tutoring in the subject of his/her choice.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year."
10967721|NCT00895154|BG001|Baseline|Tutoring + Memory Training Group|"Participants will receive tutoring and memory training.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year.~Memory Training: Participants will receive memory training for approximately 8-10 hours per month during the school year. Specific memory training strategies used will include silent rehearsal training and semantic clustering training."
10967722|NCT00895154|BG002|Baseline|Total|Total of all reporting groups
10967723|NCT00895154|FG000|Participant Flow|General Tutoring Group|"Participants will receive general tutoring in the subject of his/her choice.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year."
10967724|NCT00895154|FG001|Participant Flow|Tutoring + Memory Training Group|"Participants will receive tutoring and memory training.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year.~Memory Training: Participants will receive memory training for approximately 8-10 hours per month during the school year. Specific memory training strategies used will include silent rehearsal training and semantic clustering training."
10967725|NCT00895154|OG000|Outcome|General Tutoring Group|"Participants will receive general tutoring in the subject of his/her choice.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year."
10967726|NCT00895154|OG001|Outcome|Tutoring + Memory Training Group|"Participants will receive tutoring and memory training.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year.~Memory Training: Participants will receive memory training for approximately 8-10 hours per month during the school year. Specific memory training strategies used will include silent rehearsal training and semantic clustering training."
10967727|NCT00895154|EG000|Reported Event|General Tutoring Group|"Participants will receive general tutoring in the subject of his/her choice.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year."
10967728|NCT00895154|EG001|Reported Event|Tutoring + Memory Training Group|"Participants will receive tutoring and memory training.~General Tutoring: Participants will be tutored for approximately 8-10 hours per month during the school year.~Memory Training: Participants will receive memory training for approximately 8-10 hours per month during the school year. Specific memory training strategies used will include silent rehearsal training and semantic clustering training."
10967729|NCT00895180|BG000|Baseline|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967730|NCT00895180|BG001|Baseline|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967731|NCT00895180|BG002|Baseline|Total|Total of all reporting groups
10967732|NCT00895180|FG000|Participant Flow|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967733|NCT00895180|FG001|Participant Flow|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967734|NCT00895180|OG000|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967735|NCT00895180|OG001|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10817192|NCT03447314|BG002|Baseline|Part 1a: 150ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817193|NCT03447314|BG003|Baseline|Part 1a: 200ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817194|NCT03447314|BG004|Baseline|Part 1a: 250ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817195|NCT03447314|BG005|Baseline|Part 1b: 50ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817196|NCT03447314|BG006|Baseline|Part 1b: 100ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817197|NCT03447314|BG007|Baseline|Part 1b: 150ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817198|NCT03447314|BG008|Baseline|Part 1b: 200ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817199|NCT03447314|BG009|Baseline|Part 1b: 250ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817200|NCT03447314|BG010|Baseline|Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817201|NCT03447314|BG011|Baseline|Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10967736|NCT00895180|OG000|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10817202|NCT03447314|BG012|Baseline|Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817203|NCT03447314|BG013|Baseline|Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817204|NCT03447314|BG014|Baseline|Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817205|NCT03447314|BG015|Baseline|Part 2a: GSK1795091 + 24 mg GSK3174998|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
10817206|NCT03447314|BG016|Baseline|Part 2b: GSK1795091 + 80 mg GSK3359609|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
10817207|NCT03447314|BG017|Baseline|Part 2c: GSK1795091 + 200 mg Pembrolizumab|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
10817208|NCT03447314|BG018|Baseline|Total|Total of all reporting groups
10817209|NCT03447314|FG000|Participant Flow|Part 1a: 50ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817210|NCT03447314|FG001|Participant Flow|Part 1a: 100ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817211|NCT03447314|FG002|Participant Flow|Part 1a: 150ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817212|NCT03447314|FG003|Participant Flow|Part 1a: 200ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817213|NCT03447314|FG004|Participant Flow|Part 1a: 250ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817214|NCT03447314|FG005|Participant Flow|Part 1b: 50ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817215|NCT03447314|FG006|Participant Flow|Part 1b: 100ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817216|NCT03447314|FG007|Participant Flow|Part 1b: 150ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817217|NCT03447314|FG008|Participant Flow|Part 1b: 200ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817218|NCT03447314|FG009|Participant Flow|Part 1b: 250ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817219|NCT03447314|FG010|Participant Flow|Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817220|NCT03447314|FG011|Participant Flow|Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817221|NCT03447314|FG012|Participant Flow|Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817222|NCT03447314|FG013|Participant Flow|Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10967737|NCT00895180|OG000|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10817223|NCT03447314|FG014|Participant Flow|Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817224|NCT03447314|FG015|Participant Flow|Part 2a: GSK1795091 + 24 mg GSK3174998|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
10817225|NCT03447314|FG016|Participant Flow|Part 2b: GSK1795091 + 80 mg GSK3359609|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
10817226|NCT03447314|FG017|Participant Flow|Part 2c: GSK1795091 + 200 mg Pembrolizumab|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
10817227|NCT03447314|OG000|Outcome|Part 1a: 50ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817228|NCT03447314|OG001|Outcome|Part 1a: 100ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10967738|NCT00895180|EG000|Reported Event|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967739|NCT00895180|EG001|Reported Event|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
10967740|NCT00895193|BG000|Baseline|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967741|NCT00895193|BG001|Baseline|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967742|NCT00895193|BG002|Baseline|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967743|NCT00895193|BG003|Baseline|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967744|NCT00895193|BG004|Baseline|Total|Total of all reporting groups
10967745|NCT00895193|FG000|Participant Flow|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967746|NCT00895193|FG001|Participant Flow|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967747|NCT00895193|FG002|Participant Flow|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967748|NCT00895193|FG003|Participant Flow|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967749|NCT00895193|OG000|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967750|NCT00895193|OG001|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967751|NCT00895193|OG002|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967752|NCT00895193|OG003|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967753|NCT00895193|EG000|Reported Event|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967754|NCT00895193|EG001|Reported Event|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967755|NCT00895193|EG002|Reported Event|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967756|NCT00895193|EG003|Reported Event|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
10967757|NCT00895232|BG000|Baseline|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
10967758|NCT00895232|BG001|Baseline|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
10967759|NCT00895232|BG002|Baseline|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
10967760|NCT00895232|BG003|Baseline|Total|Total of all reporting groups
10967761|NCT00895232|FG000|Participant Flow|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
10967762|NCT00895232|FG001|Participant Flow|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
10967763|NCT00895232|FG002|Participant Flow|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
10967764|NCT00895232|OG000|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
10967765|NCT00895232|OG001|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
10967766|NCT00895232|OG002|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
10967767|NCT00895232|EG000|Reported Event|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
10967768|NCT00895232|EG001|Reported Event|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
10967769|NCT00895232|EG002|Reported Event|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
10967770|NCT00895245|BG000|Baseline|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
11092553|NCT01540513|BG000|Baseline|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
10817229|NCT03447314|OG002|Outcome|Part 1a: 150ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817230|NCT03447314|OG003|Outcome|Part 1a: 200ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817231|NCT03447314|OG004|Outcome|Part 1a: 250ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817232|NCT03447314|OG005|Outcome|Part 1b: 50ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817233|NCT03447314|OG006|Outcome|Part 1b: 100ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817234|NCT03447314|OG007|Outcome|Part 1b: 150ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817235|NCT03447314|OG008|Outcome|Part 1b: 200ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817236|NCT03447314|OG009|Outcome|Part 1b: 250ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817237|NCT03447314|OG010|Outcome|Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817238|NCT03447314|OG011|Outcome|Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817239|NCT03447314|OG012|Outcome|Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817240|NCT03447314|OG013|Outcome|Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817241|NCT03447314|OG014|Outcome|Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817242|NCT03447314|OG000|Outcome|Part 2a: GSK1795091 + 24 mg GSK3174998|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
10817243|NCT03447314|OG001|Outcome|Part 2b: GSK1795091 + 80 mg GSK3359609|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
10817244|NCT03447314|OG002|Outcome|Part 2c: GSK1795091 + 200 mg Pembrolizumab|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
11244374|NCT02510664|FG001|Participant Flow|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessment."
10817245|NCT03447314|OG000|Outcome|Part 1b: 50ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817246|NCT03447314|OG001|Outcome|Part 1b: 100ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817247|NCT03447314|OG002|Outcome|Part 1b: 150ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817248|NCT03447314|OG003|Outcome|Part 1b: 200ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817249|NCT03447314|OG004|Outcome|Part 1b: 250ng GSK1795091 + 80mg GSK3359609|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
10817250|NCT03447314|OG000|Outcome|Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817251|NCT03447314|OG001|Outcome|Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817252|NCT03447314|OG002|Outcome|Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817253|NCT03447314|OG003|Outcome|Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817254|NCT03447314|OG004|Outcome|Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab|Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
10817255|NCT03447314|OG000|Outcome|Part 2b: GSK1795091 + 80 mg GSK3359609|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
10817256|NCT03447314|OG000|Outcome|Part 2c: GSK1795091 + 200 mg Pembrolizumab|Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
10817257|NCT03447314|EG000|Reported Event|Part 1a: 50ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817258|NCT03447314|EG001|Reported Event|Part 1a: 100ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817259|NCT03447314|EG002|Reported Event|Part 1a: 150ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817260|NCT03447314|EG003|Reported Event|Part 1a: 200ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817261|NCT03447314|EG004|Reported Event|Part 1a: 250ng GSK1795091 + 24mg GSK3174998|Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
10817262|NCT03447314|EG005|Reported Event|Part 1b: 50ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
10817263|NCT03447314|EG006|Reported Event|Part 1b: 100ng GSK1795091 + 80mg GSK3359609|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
11206535|NCT02236598|OG000|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
10817264|NCT03447314|EG007|Reported Event|Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817265|NCT03447314|EG008|Reported Event|Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab|Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
10817266|NCT03422653|BG000|Baseline|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817267|NCT03422653|BG001|Baseline|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
10817268|NCT03422653|BG002|Baseline|Total|Total of all reporting groups
10817269|NCT03422653|FG000|Participant Flow|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817270|NCT03422653|FG001|Participant Flow|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
10817271|NCT03422653|FG002|Participant Flow|Open-label CR845 0.5 mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817272|NCT03422653|OG000|Outcome|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817273|NCT03422653|OG001|Outcome|Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
10817274|NCT03422653|OG000|Outcome|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817275|NCT03422653|OG001|Outcome|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
10817276|NCT03422653|EG000|Reported Event|Double-blind CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817277|NCT03422653|EG001|Reported Event|Double-blind Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
10817278|NCT03422653|EG002|Reported Event|Open-label CR845 0.5 mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
10817279|NCT03320330|BG000|Baseline|Part A|Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors.
10817280|NCT03320330|BG001|Baseline|Part A PK|Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors.
10817281|NCT03320330|BG002|Baseline|Part B|Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors.
11206536|NCT02236598|OG001|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
11206537|NCT02236598|EG000|Reported Event|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
11206538|NCT02236598|EG001|Reported Event|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
10817282|NCT03320330|BG003|Baseline|Total|Total of all reporting groups
10817283|NCT03320330|FG000|Participant Flow|Part A: 20 mg/kg (Phase 1)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817284|NCT03320330|FG001|Participant Flow|Part A PK: 20 mg/kg (Expansion)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817285|NCT03320330|FG002|Participant Flow|Part B: 20 mg/kg (Phase 2)|"Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817286|NCT03320330|OG000|Outcome|Part A: 20 mg/kg (Phase 1)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
11206539|NCT02236611|BG000|Baseline|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
11206540|NCT02236611|BG001|Baseline|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
11206541|NCT02236611|BG002|Baseline|Total|Total of all reporting groups
11206542|NCT02236611|FG000|Participant Flow|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
11206543|NCT02236611|FG001|Participant Flow|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
11206544|NCT02236611|OG000|Outcome|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
11206545|NCT02236611|OG001|Outcome|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
10817287|NCT03320330|OG001|Outcome|Part A PK: 20 mg/kg (Expansion)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817288|NCT03320330|OG002|Outcome|Part B: 20 mg/kg (Phase 2)|"Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817289|NCT03320330|OG000|Outcome|Part B: 20 mg/kg (Phase 2)|"Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817290|NCT03320330|EG000|Reported Event|Part A: 20 mg/kg (Phase 1)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817291|NCT03320330|EG001|Reported Event|Part A PK: 20 mg/kg (Expansion)|"Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817292|NCT03320330|EG002|Reported Event|Part B: 20 mg/kg (Phase 2)|"Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies"
10817293|NCT03271151|BG000|Baseline|"Duloxetine (Cymbalta)"|"Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine (Cymbalta) in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.~Cymbalta: Duloxetine (Cymbalta) is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain"
11206546|NCT02236611|EG000|Reported Event|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
10817294|NCT03271151|BG001|Baseline|Placebo|"Placebo to compare pain scores and opioid use againts Duloxetine~Placebo: Placebo to compare outcomes against Duloxetine"
10817295|NCT03271151|BG002|Baseline|Total|Total of all reporting groups
10822039|NCT00074152|BG001|Baseline|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
10822040|NCT00074152|BG002|Baseline|Total|Total of all reporting groups
10822041|NCT00074152|FG000|Participant Flow|Observation|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
11206547|NCT02236611|EG001|Reported Event|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
11206548|NCT02236767|BG000|Baseline|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
11206549|NCT02236767|FG000|Participant Flow|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
11206550|NCT02236767|OG000|Outcome|rTMS Treatment|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
10817296|NCT03271151|FG000|Participant Flow|"Duloxetine (Cymbalta)"|"Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine (Cymbalta) in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.~Cymbalta: Duloxetine (Cymbalta) is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain"
10817297|NCT03271151|FG001|Participant Flow|Placebo|"Placebo to compare pain scores and opioid use againts Duloxetine~Placebo: Placebo to compare outcomes against Duloxetine"
10817298|NCT03271151|OG000|Outcome|"Duloxetine (Cymbalta)"|"Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine (Cymbalta) in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.~Cymbalta: Duloxetine (Cymbalta) is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain"
10817299|NCT03271151|OG001|Outcome|Placebo|"Placebo to compare pain scores and opioid use againts Duloxetine~Placebo: Placebo to compare outcomes against Duloxetine"
10817300|NCT03271151|EG000|Reported Event|"Duloxetine (Cymbalta)"|"Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine (Cymbalta) in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.~Cymbalta: Duloxetine (Cymbalta) is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain"
10817301|NCT03271151|EG001|Reported Event|Placebo|"Placebo to compare pain scores and opioid use againts Duloxetine~Placebo: Placebo to compare outcomes against Duloxetine"
10817302|NCT03141177|BG000|Baseline|Treatment A|Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
10817303|NCT03141177|BG001|Baseline|Treatment B|"Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)~Then~Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD"
10817304|NCT03141177|BG002|Baseline|Treatment C|Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
10817305|NCT03141177|BG003|Baseline|Total|Total of all reporting groups
10817306|NCT03141177|FG000|Participant Flow|Treatment A|Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
10817307|NCT03141177|FG001|Participant Flow|Treatment B|"Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)~Then~Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD"
10817308|NCT03141177|FG002|Participant Flow|Treatment C|Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
10817309|NCT03141177|OG000|Outcome|Treatment A|Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
10817310|NCT03141177|OG001|Outcome|Treatment C|Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
10817311|NCT03141177|OG001|Outcome|Treatment B|"Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)~Then~Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD"
10817312|NCT03141177|OG002|Outcome|Treatment C|Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
10817313|NCT03141177|EG000|Reported Event|Treatment A|Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
10817314|NCT03141177|EG001|Reported Event|Treatment B|"Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)~Then~Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD"
10817315|NCT03141177|EG002|Reported Event|Treatment C|Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
10967771|NCT00895245|FG000|Participant Flow|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
10967772|NCT00895245|OG000|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
10967773|NCT00895245|EG000|Reported Event|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
10967774|NCT00895310|BG000|Baseline|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
10967775|NCT00895310|FG000|Participant Flow|Ketoconazole|"Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening)~Ketoconazole: Ketoconazole is taken three times a day by mouth."
10967776|NCT00895310|OG000|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
10967777|NCT00895310|EG000|Reported Event|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
10967778|NCT00895414|BG000|Baseline|All Study Participants|Patients who were randomized to receive either doxorubicin hydrochloride alone or doxorubicin hydrochloride with enalapril.
10967779|NCT00895414|FG000|Participant Flow|Doxorubicin Alone First, Then Doxorubicin With Enalapril|"Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Beginning 1 week before course 2, patients additionally receive oral enalapril maleate once daily until day 8 of course 2."
10967780|NCT00895414|FG001|Participant Flow|Doxorubicin With Enalapril First, Then Doxorubicin Alone|"Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Beginning 1 week before course 1, patients additionally receive oral enalapril maleate once daily until day 8 of course 1."
10967781|NCT00895414|OG000|Outcome|Doxorubicin Hydrochloride Alone|Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.
10967782|NCT00895414|OG001|Outcome|Doxorubicin Hydrochloride With Enalapril|Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.
10967783|NCT00895414|EG000|Reported Event|Doxorubicin Alone First, Then Doxorubicin With Enalapril|"Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Beginning 1 week before course 2, patients additionally receive oral enalapril maleate once daily until day 8 of course 2."
10967784|NCT00895414|EG001|Reported Event|Doxorubicin With Enalapril First, Then Doxorubicin Alone|"Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Beginning 1 week before course 1, patients additionally receive oral enalapril maleate once daily until day 8 of course 1."
10967785|NCT00895453|BG000|Baseline|Itraconazole|itraconazole alone
10967786|NCT00895453|BG001|Baseline|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
10967787|NCT00895453|BG002|Baseline|Classic Homeopathy|
10967788|NCT00895453|BG003|Baseline|Total|Total of all reporting groups
10967789|NCT00895453|FG000|Participant Flow|Itraconazole|itraconazole alone
10967790|NCT00895453|FG001|Participant Flow|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
10967791|NCT00895453|FG002|Participant Flow|Classic Homeopathy|
10967792|NCT00895453|OG000|Outcome|Itraconazole|itraconazole alone
10967793|NCT00895453|OG001|Outcome|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
10967794|NCT00895453|OG002|Outcome|Classic Homeopathy|
10967795|NCT00895453|EG000|Reported Event|Itraconazole|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)"
10817316|NCT03117049|BG000|Baseline|ONO-4538 Group|"ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817317|NCT03117049|BG001|Baseline|Placebo Group|"Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817318|NCT03117049|BG002|Baseline|Total|Total of all reporting groups
10817319|NCT03117049|FG000|Participant Flow|ONO-4538 Group|"ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817320|NCT03117049|FG001|Participant Flow|Placebo Group|"Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817321|NCT03117049|OG000|Outcome|ONO-4538 Group|"ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817322|NCT03117049|OG001|Outcome|Placebo Group|"Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817323|NCT03117049|EG000|Reported Event|ONO-4538 Group|"ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817324|NCT03117049|EG001|Reported Event|Placebo Group|"Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.~Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent."
10817325|NCT03023813|BG000|Baseline|Intervention|"Individualized preventive care recommendations will be distributed to subjects.~Intervention: Written material provided."
10817326|NCT03023813|BG001|Baseline|Control|Usual care
10817327|NCT03023813|BG002|Baseline|Development Phase|"Non-randomized receipt of individualized preventive care recommendations~Intervention: Written material provided."
10817328|NCT03023813|BG003|Baseline|Total|Total of all reporting groups
10817329|NCT03023813|FG000|Participant Flow|Intervention|"Individualized preventive care recommendations will be distributed to subjects.~Intervention: Written material provided."
10817330|NCT03023813|FG001|Participant Flow|Control|Usual care
10817331|NCT03023813|FG002|Participant Flow|Development Phase|"Non-randomized receipt of individualized preventive care recommendations~Intervention: Written material provided."
10817332|NCT03023813|OG000|Outcome|Intervention|"Individualized preventive care recommendations will be distributed to subjects.~Intervention: Written material provided."
10817333|NCT03023813|OG001|Outcome|Control|Usual care
10817334|NCT03023813|OG002|Outcome|Development Phase|"Non-randomized receipt of individualized preventive care recommendations~Intervention: Written material provided."
10817335|NCT03023813|OG002|Outcome|Development Phase|Non-randomized receipt of individualized preventive care recommendations
10817336|NCT03023813|EG000|Reported Event|Intervention|"Individualized preventive care recommendations will be distributed to subjects.~Intervention: Written material provided."
10817337|NCT03023813|EG001|Reported Event|Control|Usual care
10817338|NCT03023813|EG002|Reported Event|Development Phase|"Non-randomized receipt of individualized preventive care recommendations~Intervention: Written material provided."
10817339|NCT02993822|BG000|Baseline|Orvepitant 10mg|"Orvepitant 10mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817340|NCT02993822|BG001|Baseline|Orvepitant 20mg|"Orvepitant 20mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817341|NCT02993822|BG002|Baseline|Orvepitant 30mg|"Orvepitant 30mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817342|NCT02993822|BG003|Baseline|Placebo|"Placebo to match tablet, once daily for 12 weeks~Placebo: Tablet, once daily, oral"
10817343|NCT02993822|BG004|Baseline|Total|Total of all reporting groups
10817344|NCT02993822|FG000|Participant Flow|Orvepitant 10mg|"Orvepitant 10mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817345|NCT02993822|FG001|Participant Flow|Orvepitant 20mg|"Orvepitant 20mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817346|NCT02993822|FG002|Participant Flow|Orvepitant 30mg|"Orvepitant 30mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817347|NCT02993822|FG003|Participant Flow|Placebo|"Placebo to match tablet, once daily for 12 weeks~Placebo: Tablet, once daily, oral"
10817348|NCT02993822|OG000|Outcome|Orvepitant 10mg|"Orvepitant 10mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817349|NCT02993822|OG001|Outcome|Orvepitant 20mg|"Orvepitant 20mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817350|NCT02993822|OG002|Outcome|Orvepitant 30mg|"Orvepitant 30mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817351|NCT02993822|OG003|Outcome|Placebo|"Placebo to match tablet, once daily for 12 weeks~Placebo: Tablet, once daily, oral"
10817352|NCT02993822|EG000|Reported Event|Orvepitant 10mg|"Orvepitant 10mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817353|NCT02993822|EG001|Reported Event|Orvepitant 20mg|"Orvepitant 20mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817354|NCT02993822|EG002|Reported Event|Orvepitant 30mg|"Orvepitant 30mg tablet, once daily for 12 weeks~Orvepitant Maleate: Tablet, once daily, oral"
10817355|NCT02993822|EG003|Reported Event|Placebo|"Placebo to match tablet, once daily for 12 weeks~Placebo: Tablet, once daily, oral"
10817356|NCT02924324|BG000|Baseline|Propofol With Placebo First Then Propofol With Ropivacaine|ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
10817357|NCT02924324|BG001|Baseline|Propofol With Ropivacaine First Then Propofol With Placebo|ARM 2: 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
10817358|NCT02924324|BG002|Baseline|Total|Total of all reporting groups
10817359|NCT02924324|FG000|Participant Flow|Propofol With Placebo First Then Propofol With Ropivacaine|ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
10817360|NCT02924324|FG001|Participant Flow|Propofol With Ropivacaine First Then Propofol With Placebo|ARM 2: 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
10817361|NCT02924324|OG000|Outcome|Propofol Alone|Participants who received propofol alone
10817362|NCT02924324|OG001|Outcome|Propofol & Ropivacaine|Participants who received propofol & ropivacaine
10817363|NCT02924324|EG000|Reported Event|Propofol|Participants received propofol alone
10817364|NCT02924324|EG001|Reported Event|Propofol and Ropivacaine|Participants received propofol & ropivacaine in combination
10817365|NCT02828917|BG000|Baseline|MedJ-01 Drug Eluting Stent|"MedJ-01 Ridaforolimus eluting coronary stent system~MedJ-01 Ridaforolimus Eluting Coronary Stent System"
10817366|NCT02828917|FG000|Participant Flow|MedJ-01 Drug Eluting Stent|"MedJ-01 Ridaforolimus eluting coronary stent system~MedJ-01 Ridaforolimus Eluting Coronary Stent System"
10817367|NCT02828917|OG000|Outcome|MedJ-01 Drug Eluting Stent|"MedJ-01 Ridaforolimus eluting coronary stent system~MedJ-01 Ridaforolimus Eluting Coronary Stent System"
10817368|NCT02828917|EG000|Reported Event|MedJ-01 Drug Eluting Stent|"MedJ-01 Ridaforolimus eluting coronary stent system~MedJ-01 Ridaforolimus Eluting Coronary Stent System"
10817369|NCT02753127|BG000|Baseline|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion or at least 2 hours following the first daily dose of napabucasin if bevacizumab is not administered. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle."
10817370|NCT02753127|BG001|Baseline|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle
10817371|NCT02753127|BG002|Baseline|Total|Total of all reporting groups
10822042|NCT00074152|FG001|Participant Flow|Chemotherapy|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
10822043|NCT00074152|OG000|Outcome|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
10817372|NCT02753127|FG000|Participant Flow|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion or at least 2 hours following the first daily dose of napabucasin if bevacizumab is not administered. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle"
10817373|NCT02753127|FG001|Participant Flow|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle.
10817374|NCT02753127|OG000|Outcome|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion or at least 2 hours following the first daily dose of napabucasin if bevacizumab is not administered. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle."
10817375|NCT02753127|OG001|Outcome|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m^2 together with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion. 5-FU 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle
10817376|NCT02753127|OG000|Outcome|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Analysis population of DCR will be based on patients with measurable disease by RECIST 1.1 at randomization."
10817377|NCT02753127|OG001|Outcome|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Analysis population of DCR will be based on patients with measurable disease by RECIST 1.1 at randomization.
10817378|NCT02753127|OG000|Outcome|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Analysis set for ORR will be based on patients with measurable disease by RECIST 1.1 at randomization."
10817379|NCT02753127|OG001|Outcome|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Analysis set for ORR will be based on patients with measurable disease by RECIST 1.1 at randomization.
10817380|NCT02753127|OG000|Outcome|Napabucasin + FOLFIRI ± Bevacizumab|"Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Number of patients is with at least one valid assessment at each analysis window."
10817381|NCT02753127|OG001|Outcome|FOLFIRI ± Bevacizumab|Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. This regimen will be repeated on Day 1 of every 14 day cycle. Number of patients is with at least one valid assessment at each analysis window.
10817382|NCT02753127|OG000|Outcome|Napabucasin + FOLFIRI ± Bevacizumab|"All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle."
10817383|NCT02753127|OG001|Outcome|FOLFIRI ± Bevacizumab|All patients who received at least 1 dose of study drug (FOLFIRI) with treatment assignment designated according to the actual study treatment received. Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle.
10817384|NCT02753127|EG000|Reported Event|Napabucasin + FOLFIRI ± Bevacizumab|"All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle."
10817385|NCT02753127|EG001|Reported Event|FOLFIRI ± Bevacizumab|All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle.
10817386|NCT02744430|BG000|Baseline|Arm 1 - Active|"Mirabegron 50 mg orally once every 24 hours starting immediately~Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817387|NCT02744430|BG001|Baseline|Arm 2 - Placebo|"Placebo orally once every 24 hours starting immediately~Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817388|NCT02744430|BG002|Baseline|Total|Total of all reporting groups
10817389|NCT02744430|FG000|Participant Flow|Arm 1 - Active|"Mirabegron 50 mg orally once every 24 hours starting immediately~Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817390|NCT02744430|FG001|Participant Flow|Arm 2 - Placebo|"Placebo orally once every 24 hours starting immediately~Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817391|NCT02744430|OG000|Outcome|Arm 1 - Active|"Mirabegron 50 mg orally once every 24 hours starting immediately~Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817392|NCT02744430|OG001|Outcome|Arm 2 - Placebo|"Placebo orally once every 24 hours starting immediately~Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817393|NCT02744430|EG000|Reported Event|Arm 2 - Placebo|"Placebo orally once every 24 hours starting immediately~Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817394|NCT02744430|EG001|Reported Event|Arm 1 - Active|"Mirabegron 50 mg orally once every 24 hours starting immediately~Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet."
10817395|NCT02460198|BG000|Baseline|Cohort A - Pembrolizumab 200 mg|Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
10822044|NCT00074152|OG001|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
10967796|NCT00895453|EG001|Reported Event|Itraconazole + Lactobacilli Agent|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)~lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days"
10967797|NCT00895453|EG002|Reported Event|Classic Homeopathy (CH)|"CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.~classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000."
10967798|NCT00895531|BG000|Baseline|Peripheral Nerve Group|
10967799|NCT00895531|BG001|Baseline|Depodur Group|
10967800|NCT00895531|BG002|Baseline|Total|Total of all reporting groups
10967801|NCT00895531|FG000|Participant Flow|Peripheral Nerve Group|
10967802|NCT00895531|FG001|Participant Flow|Depodur Group|
10967803|NCT00895531|OG000|Outcome|Peripheral Nerve Group|
10967804|NCT00895531|OG001|Outcome|Depodur Group|
10967805|NCT00895531|EG000|Reported Event|Peripheral Nerve Group|
10967806|NCT00895531|EG001|Reported Event|Depodur Group|
10967807|NCT00895583|BG000|Baseline|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967808|NCT00895583|BG001|Baseline|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967809|NCT00895583|BG002|Baseline|Total|Total of all reporting groups
10967810|NCT00895583|FG000|Participant Flow|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967811|NCT00895583|FG001|Participant Flow|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967812|NCT00895583|OG000|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967813|NCT00895583|OG001|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967814|NCT00895583|EG000|Reported Event|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967815|NCT00895583|EG001|Reported Event|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center's standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
10967816|NCT00895622|BG000|Baseline|Low Risk|No treatment given
10967817|NCT00895622|BG001|Baseline|Intermidiate Risk|54 Gy radiotherapy
10967818|NCT00895622|BG002|Baseline|High Risk|60 Gy radiotherapy
10967819|NCT00895622|BG003|Baseline|Total|Total of all reporting groups
10967820|NCT00895622|FG000|Participant Flow|Low Risk|No treatment given
10967821|NCT00895622|FG001|Participant Flow|Intermidiate Risk|54 Gy radiotherapy
10967822|NCT00895622|FG002|Participant Flow|High Risk|60 Gy radiotherapy
10967823|NCT00895622|OG000|Outcome|Low Risk|No treatment given
10967824|NCT00895622|OG001|Outcome|Intermidiate Risk|54 Gy radiotherapy
10967825|NCT00895622|OG002|Outcome|High Risk|60 Gy radiotherapy
10967826|NCT00895622|OG000|Outcome|Intermidiate Risk|54 Gy radiotherapy
10967827|NCT00895622|OG001|Outcome|High Risk|60 Gy radiotherapy
10967828|NCT00895622|OG000|Outcome|MRI at Diagnosis|
10967829|NCT00895622|OG001|Outcome|MRI at First Progression|
10967830|NCT00895622|OG002|Outcome|MRI at 3 Years|
10967831|NCT00895622|OG000|Outcome|Central Review: Benign|
10967832|NCT00895622|OG001|Outcome|Central Review: Atypical|
10967833|NCT00895622|OG002|Outcome|Central Review: Anaplastic|
10967834|NCT00895622|EG000|Reported Event|Low Risk|No treatment given
10967835|NCT00895622|EG001|Reported Event|Intermidiate Risk|54 Gy radiotherapy
10967836|NCT00895622|EG002|Reported Event|High Risk|60 Gy radiotherapy
10967837|NCT00895661|BG000|Baseline|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
10967838|NCT00895661|FG000|Participant Flow|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
10967839|NCT00895661|OG000|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
10967840|NCT00895661|EG000|Reported Event|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
10967841|NCT00895752|BG000|Baseline|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
10967842|NCT00895752|FG000|Participant Flow|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
10967843|NCT00895752|OG000|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
10967844|NCT00895752|OG000|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
10967845|NCT00895752|OG000|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
10967846|NCT00895752|EG000|Reported Event|Riluzole|"Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.~Riluzole: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day."
10967847|NCT00895817|BG000|Baseline|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
10967848|NCT00895817|BG001|Baseline|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
10967849|NCT00895817|BG002|Baseline|Total|Total of all reporting groups
10967850|NCT00895817|FG000|Participant Flow|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
10967851|NCT00895817|FG001|Participant Flow|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
10967852|NCT00895817|OG000|Outcome|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
10967853|NCT00895817|OG001|Outcome|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
10967854|NCT00895817|EG000|Reported Event|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
10967855|NCT00895817|EG001|Reported Event|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
10967856|NCT00895830|BG000|Baseline|Placebo|
10967857|NCT00895830|BG001|Baseline|APD405 0.3mg Dose|
10967858|NCT00895830|BG002|Baseline|APD405 1mg Dose|
10967859|NCT00895830|BG003|Baseline|APD405 2mg Dose|
10967860|NCT00895830|BG004|Baseline|APD405 3mg Dose|
10967861|NCT00895830|BG005|Baseline|Total|Total of all reporting groups
10967862|NCT00895830|FG000|Participant Flow|Placebo|
10967863|NCT00895830|FG001|Participant Flow|APD405 0.3mg Dose|
10967864|NCT00895830|FG002|Participant Flow|APD405 1mg Dose|
10967865|NCT00895830|FG003|Participant Flow|APD405 2mg Dose|
10967866|NCT00895830|FG004|Participant Flow|APD405 3mg Dose|
10967867|NCT00895830|OG000|Outcome|Placebo|
10967868|NCT00895830|OG001|Outcome|APD405 0.3mg Dose|
10967869|NCT00895830|OG002|Outcome|APD405 1mg Dose|
10817396|NCT02460198|BG001|Baseline|Cohort B - Pembrolizumab 200 mg|Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
10817397|NCT02460198|BG002|Baseline|Total|Total of all reporting groups
10817398|NCT02460198|FG000|Participant Flow|Cohort A - Pembrolizumab 200 mg|Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
10817399|NCT02460198|FG001|Participant Flow|Cohort B - Pembrolizumab 200 mg|Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
10817400|NCT02460198|OG000|Outcome|Cohort A - Pembrolizumab 200 mg|Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
10817401|NCT02460198|OG001|Outcome|Cohort B - Pembrolizumab 200 mg|Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
10817402|NCT02460198|EG000|Reported Event|Cohort A First Course|Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
10817403|NCT02460198|EG001|Reported Event|Cohort B First Course|Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
10817404|NCT02460198|EG002|Reported Event|Cohort A Second Course|Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
10967870|NCT00895830|OG003|Outcome|APD405 2mg Dose|
10817405|NCT02460198|EG003|Reported Event|Cohort B Second Course|Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
10817406|NCT02260869|BG000|Baseline|Cooled Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe
10817407|NCT02260869|BG001|Baseline|Monopolar Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
10817408|NCT02260869|BG002|Baseline|Total|Total of all reporting groups
10817409|NCT02260869|FG000|Participant Flow|Cooled Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe
10817410|NCT02260869|FG001|Participant Flow|Monopolar Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
10817411|NCT02260869|OG000|Outcome|Cooled Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe
10817412|NCT02260869|OG001|Outcome|Monopolar Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
10817413|NCT02260869|EG000|Reported Event|Cooled Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe
10817414|NCT02260869|EG001|Reported Event|Monopolar Radiofrequency Ablation|Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
10817415|NCT02255838|BG000|Baseline|Disposable Bronchoscope Insertion Followed by Reusable Bronchoscope Insertion or Vice Versa|Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
10967871|NCT00895830|OG004|Outcome|APD405 3mg Dose|
10967872|NCT00895830|EG000|Reported Event|Placebo|
10822045|NCT00074152|OG000|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
10967873|NCT00895830|EG001|Reported Event|APD405 0.3mg Dose|
10967874|NCT00895830|EG002|Reported Event|APD405 1mg Dose|
10967875|NCT00895830|EG003|Reported Event|APD405 2mg Dose|
10967876|NCT00895830|EG004|Reported Event|APD405 3mg Dose|
10817416|NCT02255838|FG000|Participant Flow|Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)|Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
10817417|NCT02255838|FG001|Participant Flow|Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)|Randomly controlled, either the reusable bronchoscope (Storz 8402) was inserted first into the trachea and advanced into the right lung. Subsequently, disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
10817418|NCT02255838|OG000|Outcome|Bronchoscope Disposable, aScope IV|Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.
10817419|NCT02255838|OG001|Outcome|Reusable Bronchoscope (Storz 8402)|Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
10817420|NCT02255838|OG001|Outcome|Reusable Bronchoscope(Storz 8402)|Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
10817421|NCT02255838|OG001|Outcome|Bronchoscope Reusable Storz 8402 2x|Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
10817422|NCT02255838|EG000|Reported Event|Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)|no adverse events
10817423|NCT02255838|EG001|Reported Event|Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)|no adverse events
10817424|NCT02151526|BG000|Baseline|LentiGlobin BB305 Drug Product for SCD|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 milligram per kilogram per day (mg/kg/day) busulfan intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of greater than or equal to (> or =) 2.0×10^6 cluster of differentiation (CD) 34+ cells/kg LentiGlobin BB305 Drug Product was administered to participants with SCD by IV infusion.
10817425|NCT02151526|BG001|Baseline|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product (betibeglogene autotemcel) was administered to participants with TDT by IV infusion.
10817426|NCT02151526|BG002|Baseline|Total|Total of all reporting groups
10817427|NCT02151526|FG000|Participant Flow|LentiGlobin BB305 Drug Product for SCD|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 milligram per kilogram per day (mg/kg/day) busulfan intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of greater than or equal to (> or =) 2.0×10^6 cluster of differentiation (CD) 34+ cells/kg LentiGlobin BB305 Drug Product was administered to participants with SCD by IV infusion.
10817428|NCT02151526|FG001|Participant Flow|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product (betibeglogene autotemcel) was administered to participants with TDT by IV infusion.
10817429|NCT02151526|OG000|Outcome|LentiGlobin BB305 Drug Product for SCD|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 milligram per kilogram per day (mg/kg/day) busulfan intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of greater than or equal to (> or =) 2.0×10^6 cluster of differentiation (CD) 34+ cells/kg LentiGlobin BB305 Drug Product was administered to participants with SCD by IV infusion.
10817430|NCT02151526|OG001|Outcome|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product (betibeglogene autotemcel) was administered to participants with TDT by IV infusion.
10822046|NCT00074152|EG000|Reported Event|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
10817431|NCT02151526|OG000|Outcome|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product (betibeglogene autotemcel) was administered to participants with TDT by IV infusion.
10817432|NCT02151526|OG000|Outcome|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product was administered to participants with TDT by IV infusion.
10817433|NCT02151526|EG000|Reported Event|LentiGlobin BB305 Drug Product for SCD|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 milligram per kilogram per day (mg/kg/day) busulfan intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of greater than or equal to (> or =) 2.0×10^6 cluster of differentiation (CD) 34+ cells/kg LentiGlobin BB305 Drug Product was administered to participants with SCD by IV infusion.
10817434|NCT02151526|EG001|Reported Event|LentiGlobin BB305 Drug Product for TDT|Following myeloablative conditioning with a dose (dose may be adjusted as per protocol) of 3.2 mg/kg/day busulfan Intravenous (IV) for 4 consecutive days and subsequent daily monitoring of busulfan levels for confirmation of adequate washout, a single dose of > or =3.0 × 10^6 CD34+ cells/kg LentiGlobin BB305 Drug Product (betibeglogene autotemcel) was administered to participants with TDT by IV infusion.
10817435|NCT02119468|BG000|Baseline|Dose Level #1 (3mg MLN9708)|"Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ixazomib citrate: Given orally~dexamethasone: Given orally~pomalidomide: Given orally"
10817436|NCT02119468|BG001|Baseline|Dose Level #2 (4mg MLN9708)|"Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ixazomib citrate: Given orally~dexamethasone: Given orally~pomalidomide: Given orally"
10817437|NCT02119468|BG002|Baseline|Total|Total of all reporting groups
10817438|NCT02119468|FG000|Participant Flow|Dose Level #1 (3mg MLN9708)|"Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ixazomib citrate: Given orally~dexamethasone: Given orally~pomalidomide: Given orally"
10817439|NCT02119468|FG001|Participant Flow|Dose Level #2 (4mg MLN9708)|Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10817440|NCT02119468|OG000|Outcome|Dose Level #1: 3mg MLN9708|Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10817441|NCT02119468|OG001|Outcome|Dose Level #2: 4mg MLN9708|Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10817442|NCT02119468|OG000|Outcome|Dose Level #2 (4mg MLN9708)|Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10817443|NCT02119468|EG000|Reported Event|Dose Level #1 (3mg MLN9708)|"Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ixazomib citrate: Given orally~dexamethasone: Given orally~pomalidomide: Given orally"
10817444|NCT02119468|EG001|Reported Event|Dose Level #2 (4mg MLN9708)|"Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ixazomib citrate: Given orally~dexamethasone: Given orally~pomalidomide: Given orally"
10817445|NCT01960530|BG000|Baseline|All Participants|All participants received no IMP, dexamethasone (non-IMP), oral infacort, oral hydrocortisone, i.v. hydrocortisone
10817446|NCT01960530|FG000|Participant Flow|5-period Crossover|"Study Period 1 (Endogenous Cortisol): No IMP was administered. Subjects were observed over a 24 hour period, during which sleep disruption was minimised, to record their endogenous cortisol production as a baseline figure and to confirm eligibility for the subsequent study periods.~Study Period 2 (Dexamethasone): Subjects were admitted to the unit following a final confirmation of eligibility, prior to administration with Dexamethasone.~Study Periods 3 and 4 (Infacort Granules or Hydrocortisone Tablets): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received both treatments (1 in Period 3, and 1 in Period 4), and were randomised using the PROC PLAN procedure of SAS. Subjects received Dexamethasone 1 hour prior to IMP administration.~Study Period 5 (I.V. Hydrocortisone Injection): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received Dexamethasone 1 hour prior to IMP administration."
10817447|NCT01960530|OG000|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
10967877|NCT00895843|BG000|Baseline|Conventional Ibuprofen|
10967878|NCT00895843|BG001|Baseline|Brufen Retard|
10967879|NCT00895843|BG002|Baseline|Total|Total of all reporting groups
10967880|NCT00895843|FG000|Participant Flow|Conventional Ibuprofen|
10817448|NCT01960530|OG001|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
10817449|NCT01960530|OG002|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
10817450|NCT01960530|OG000|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
10817451|NCT01960530|OG001|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
10817452|NCT01960530|OG002|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
10817453|NCT01960530|OG003|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
10817454|NCT01960530|OG004|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
10817455|NCT01960530|EG000|Reported Event|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
10817456|NCT01960530|EG001|Reported Event|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
10817457|NCT01960530|EG002|Reported Event|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
10817458|NCT01960530|EG003|Reported Event|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
10817459|NCT01960530|EG004|Reported Event|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
10822047|NCT00074152|EG001|Reported Event|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
10822048|NCT00074165|BG000|Baseline|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
10822049|NCT00074165|FG000|Participant Flow|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
10822050|NCT00074165|OG000|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
10822051|NCT00074165|EG000|Reported Event|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
10822052|NCT00074269|BG000|Baseline|Pilot Study of Allogeneic Transplant for Metastatic Breast Can|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
10822053|NCT00074269|FG000|Participant Flow|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
10822054|NCT00074269|OG000|Outcome|Treatment|"Toxicity~anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
10822055|NCT00074269|OG000|Outcome|Treatment|Patients treated on protocol
10817460|NCT01516216|BG000|Baseline|Chemotherapy + Standard Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817461|NCT01516216|BG001|Baseline|Chemotherapy + Higher Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817462|NCT01516216|BG002|Baseline|Total|Total of all reporting groups
10817463|NCT01516216|FG000|Participant Flow|Chemotherapy + Standard Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817464|NCT01516216|FG001|Participant Flow|Chemotherapy + Higher Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817465|NCT01516216|OG000|Outcome|Chemotherapy + Standard Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817466|NCT01516216|OG001|Outcome|Chemotherapy + Higher Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817467|NCT01516216|OG000|Outcome|All Participants With Baseline Plasma 25 (OH) D Level|Evaluated prior to treatment.
10817468|NCT01516216|OG000|Outcome|All Participants of the Study|70 were assigned FOLFOX-bevacizumab q 2 weeks + 400 IU vitamin D3 orally once daily, 69 were assigned FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.
10817469|NCT01516216|EG000|Reported Event|Chemotherapy + Standard Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817470|NCT01516216|EG001|Reported Event|Chemotherapy + Higher Dose Vitamin D|"FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons."
10817471|NCT00519818|BG000|Baseline|Cortef Then Chronocort|Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
10817472|NCT00519818|FG000|Participant Flow|Cortef Then Chronocort|Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
10817473|NCT00519818|OG000|Outcome|Cortef|Hydrocortisone immediate release tablet
10817474|NCT00519818|OG001|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
10817475|NCT00519818|EG000|Reported Event|Chronocort|Hydrocortisone modified release tablet
10817476|NCT00519818|EG001|Reported Event|Cortef|Hydrocortisone immediate release tablet
10822056|NCT00074269|OG000|Outcome|Treatment|Patients Treated Per Protocol
10967881|NCT00895843|FG001|Participant Flow|Brufen Retard|
10967882|NCT00895843|OG000|Outcome|Conventional Ibuprofen|
11206551|NCT02236767|EG000|Reported Event|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
10817486|NCT00006178|BG000|Baseline|Sirolimus and Thymoglobulin|Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
10817487|NCT00006178|FG000|Participant Flow|Sirolimus and Thymoglobulin|Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
10817488|NCT00006178|OG000|Outcome|Sirolimus and Thymoglobulin|Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
10817489|NCT00006178|EG000|Reported Event|Sirolimus and Thymoglobulin|Thymoglobulin (Sangstat) will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst)
10817490|NCT00006184|BG000|Baseline|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
10817491|NCT00006184|BG001|Baseline|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
10817492|NCT00006184|BG002|Baseline|Total|Total of all reporting groups
10817493|NCT00006184|FG000|Participant Flow|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
10817494|NCT00006184|FG001|Participant Flow|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
10817495|NCT00006184|OG000|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
10817496|NCT00006184|OG001|Outcome|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
10817497|NCT00006184|EG000|Reported Event|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
10817498|NCT00006184|EG001|Reported Event|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
10817499|NCT00006227|BG000|Baseline|Treatment (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV"
10817500|NCT00006227|FG000|Participant Flow|Treatment (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV"
10817501|NCT00006227|OG000|Outcome|Treatment (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV"
10817502|NCT00006227|EG000|Reported Event|Treatment (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV"
10817503|NCT00006237|BG000|Baseline|Interferon|interferon alfa
10817504|NCT00006237|BG001|Baseline|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
10817505|NCT00006237|BG002|Baseline|Total|Total of all reporting groups
10817506|NCT00006237|FG000|Participant Flow|Interferon|interferon alfa IV
10817507|NCT00006237|FG001|Participant Flow|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
10817508|NCT00006237|OG000|Outcome|Interferon|interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
10817509|NCT00006237|OG001|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
10817510|NCT00006237|OG000|Outcome|Interferon|interferon alfa
10817511|NCT00006237|OG000|Outcome|Interferon|Interferon
10817512|NCT00006237|OG001|Outcome|Biochemotherapy|Biochemotherapy
10817513|NCT00006237|EG000|Reported Event|Interferon|interferon alfa
10817514|NCT00006237|EG001|Reported Event|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
10967883|NCT00895843|OG001|Outcome|Brufen Retard|
10817515|NCT00006244|BG000|Baseline|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
10817516|NCT00006244|FG000|Participant Flow|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
10817517|NCT00006244|OG000|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
10817518|NCT00006244|EG000|Reported Event|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
10817519|NCT00006289|BG000|Baseline|Placebo First, Then Neurotropin|Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
10817520|NCT00006289|BG001|Baseline|Neurotropin First, Then Placebo|Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
10817521|NCT00006289|BG002|Baseline|Total|Total of all reporting groups
10817522|NCT00006289|FG000|Participant Flow|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
10817523|NCT00006289|FG001|Participant Flow|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
10817524|NCT00006289|OG000|Outcome|VAS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
10817525|NCT00006289|OG001|Outcome|VAS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin."
10817526|NCT00006289|OG002|Outcome|VAS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
10817527|NCT00006289|OG003|Outcome|VAS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo."
10817528|NCT00006289|OG000|Outcome|NRS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
10817529|NCT00006289|OG001|Outcome|NRS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. NRS was determined at the end of the 5 week-treatment of Neurotropin."
10817530|NCT00006289|OG002|Outcome|NRS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
10817531|NCT00006289|OG003|Outcome|NRS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. NRS was determined at the end of the 5 week-treatment of placebo."
10817532|NCT00006289|OG000|Outcome|MPQ After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
10817533|NCT00006289|OG001|Outcome|MPQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. MPQ was determined at the end of the 5 week-treatment of Neurotropin."
10817534|NCT00006289|OG002|Outcome|MPQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
10817535|NCT00006289|OG003|Outcome|MPQ After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. MPQ was determined at the end of the 5 week-treatment of placebo."
10817536|NCT00006289|EG000|Reported Event|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
10967884|NCT00895843|EG000|Reported Event|Conventional Ibuprofen|
11244375|NCT02510664|FG002|Participant Flow|Provider|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
11244376|NCT02510664|OG000|Outcome|Adolescent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
11244377|NCT02510664|OG001|Outcome|Parent|"There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10817537|NCT00006289|EG001|Reported Event|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
10817538|NCT00006305|BG000|Baseline|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
10817539|NCT00006305|BG001|Baseline|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
10817540|NCT00006305|BG002|Baseline|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
10817541|NCT00006305|BG003|Baseline|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
10817542|NCT00006305|BG004|Baseline|Total|Total of all reporting groups
10817543|NCT00006305|FG000|Participant Flow|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
10817544|NCT00006305|FG001|Participant Flow|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
10817545|NCT00006305|FG002|Participant Flow|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
10817546|NCT00006305|FG003|Participant Flow|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
10817547|NCT00006305|OG000|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
10817548|NCT00006305|OG001|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
10817549|NCT00006305|OG002|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
10817550|NCT00006305|OG003|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
10817551|NCT00006305|EG000|Reported Event|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
10817552|NCT00006305|EG001|Reported Event|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
10817553|NCT00006305|EG002|Reported Event|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
10817554|NCT00006305|EG003|Reported Event|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
10817555|NCT00006389|BG000|Baseline|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
10817556|NCT00006389|FG000|Participant Flow|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
10817557|NCT00006389|OG000|Outcome|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
10967885|NCT00895843|EG001|Reported Event|Brufen Retard|
10967886|NCT00895895|BG000|Baseline|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967887|NCT00895895|BG001|Baseline|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967888|NCT00895895|BG002|Baseline|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967889|NCT00895895|BG003|Baseline|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967890|NCT00895895|BG004|Baseline|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967891|NCT00895895|BG005|Baseline|Total|Total of all reporting groups
10967892|NCT00895895|FG000|Participant Flow|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967893|NCT00895895|FG001|Participant Flow|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967894|NCT00895895|FG002|Participant Flow|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967895|NCT00895895|FG003|Participant Flow|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967896|NCT00895895|FG004|Participant Flow|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967897|NCT00895895|OG000|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967898|NCT00895895|OG001|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967899|NCT00895895|OG002|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967900|NCT00895895|OG003|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967901|NCT00895895|OG004|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967902|NCT00895895|OG001|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10817558|NCT00006389|OG000|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
10817559|NCT00006389|EG000|Reported Event|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
10817560|NCT00006392|BG000|Baseline|Vitamin E|Vitamin E + matching placebo for selenium
10817561|NCT00006392|BG001|Baseline|Selenium|Selenium + matching placebo for vitamin E
10817562|NCT00006392|BG002|Baseline|Combination|Vitamin E + selenium
10817563|NCT00006392|BG003|Baseline|Placebo|Matching placebo for vitamin E + matching placebo for selenium
10817564|NCT00006392|BG004|Baseline|Total|Total of all reporting groups
10817565|NCT00006392|FG000|Participant Flow|Vitamin E|Vitamin E + matching placebo for selenium
10817566|NCT00006392|FG001|Participant Flow|Selenium|Selenium + matching placebo for vitamin E
10817567|NCT00006392|FG002|Participant Flow|Combination|Vitamin E + selenium
10817568|NCT00006392|FG003|Participant Flow|Placebo|Matching placebo for vitamin E + matching placebo for selenium
10817569|NCT00006392|OG000|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
10817570|NCT00006392|OG001|Outcome|Selenium|Selenium + matching placebo for vitamin E
10817571|NCT00006392|OG002|Outcome|Combination|Vitamin E + selenium
10817572|NCT00006392|OG003|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
10817573|NCT00006392|EG000|Reported Event|Selenium Alone|Selenium + placebo for vitamin E
10817574|NCT00006392|EG001|Reported Event|Combination|Selenium + vitamin E
10817575|NCT00006392|EG002|Reported Event|Placebo|Placebo for selenium + placebo for vitamin E
10817576|NCT00006392|EG003|Reported Event|Vitamin E Alone|Vitamin E + placebo for selenium
10817577|NCT00006400|BG000|Baseline|Hydroxyurea|Participants will receive hydroxyurea.
10817578|NCT00006400|BG001|Baseline|Placebo|Participants will receive placebo.
10817579|NCT00006400|BG002|Baseline|Total|Total of all reporting groups
10817580|NCT00006400|FG000|Participant Flow|Hydroxyurea|Participants will receive hydroxyurea.
10817581|NCT00006400|FG001|Participant Flow|Placebo|Participants will receive placebo.
10817582|NCT00006400|OG000|Outcome|Hydroxyurea|"Participants will receive hydroxyurea.~Hydroxyurea: Participants will receive hydroxyurea."
10817583|NCT00006400|OG001|Outcome|Placebo|"Participants will receive placebo.~Placebo: Participants will receive placebo."
10817584|NCT00006400|EG000|Reported Event|Hydroxyurea|Participants were to receive hydroxyurea.
10817585|NCT00006400|EG001|Reported Event|Placebo|Participants were to receive placebo.
10817586|NCT00006409|BG000|Baseline|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
10817587|NCT00006409|BG001|Baseline|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
10817588|NCT00006409|BG002|Baseline|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817589|NCT00006409|BG003|Baseline|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817590|NCT00006409|BG004|Baseline|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817591|NCT00006409|BG005|Baseline|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817592|NCT00006409|BG006|Baseline|Total|Total of all reporting groups
10817593|NCT00006409|FG000|Participant Flow|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
10817594|NCT00006409|FG001|Participant Flow|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
10817595|NCT00006409|FG002|Participant Flow|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817596|NCT00006409|FG003|Participant Flow|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817597|NCT00006409|FG004|Participant Flow|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817598|NCT00006409|FG005|Participant Flow|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817599|NCT00006409|OG000|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
10817600|NCT00006409|OG001|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
10817601|NCT00006409|OG002|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817602|NCT00006409|OG003|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817603|NCT00006409|OG004|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817604|NCT00006409|OG005|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817605|NCT00006409|EG000|Reported Event|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
10817606|NCT00006409|EG001|Reported Event|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
10817607|NCT00006409|EG002|Reported Event|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817608|NCT00006409|EG003|Reported Event|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
10817609|NCT00006409|EG004|Reported Event|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817610|NCT00006409|EG005|Reported Event|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
10817611|NCT00006411|BG000|Baseline|Cornea Assigned From Donor Age Group <66.0 Years|"cornea assigned from donor age group <66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817612|NCT00006411|BG001|Baseline|Cornea Assigned From Donor Age Group >= 66.0 Years|"cornea assigned from donor age group >= 66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817613|NCT00006411|BG002|Baseline|Total|Total of all reporting groups
10817614|NCT00006411|FG000|Participant Flow|Cornea Assigned From Donor Age Group <66.0 Years|"cornea assigned from donor age group <66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817615|NCT00006411|FG001|Participant Flow|Cornea Assigned From Donor Age Group >= 66.0 Years|"cornea assigned from donor age group >= 66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817616|NCT00006411|OG000|Outcome|Cornea Assigned From Donor Age Group <66.0 Years|"cornea assigned from donor age group <66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817617|NCT00006411|OG001|Outcome|Cornea Assigned From Donor Age Group >= 66.0 Years|"cornea assigned from donor age group >= 66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817618|NCT00006411|EG000|Reported Event|Cornea Assigned From Donor Age Group <66.0 Years|"cornea assigned from donor age group <66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817619|NCT00006411|EG001|Reported Event|Cornea Assigned From Donor Age Group >= 66.0 Years|"cornea assigned from donor age group >= 66.0 years~corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics."
10817620|NCT00006489|BG000|Baseline|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817621|NCT00006489|BG001|Baseline|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817622|NCT00006489|BG002|Baseline|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
10817623|NCT00006489|BG003|Baseline|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
10817624|NCT00006489|BG004|Baseline|Total|Total of all reporting groups
10817625|NCT00006489|FG000|Participant Flow|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817626|NCT00006489|FG001|Participant Flow|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817627|NCT00006489|FG002|Participant Flow|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
10817628|NCT00006489|FG003|Participant Flow|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
10817629|NCT00006489|OG000|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817630|NCT00006489|OG001|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817631|NCT00006489|OG002|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
10817632|NCT00006489|OG003|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
10817633|NCT00006489|EG000|Reported Event|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817634|NCT00006489|EG001|Reported Event|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
10817635|NCT00006489|EG002|Reported Event|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
10817636|NCT00006489|EG003|Reported Event|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
10817637|NCT00006604|BG000|Baseline|Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
10817638|NCT00006604|BG001|Baseline|Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
10817639|NCT00006604|BG002|Baseline|Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817640|NCT00006604|BG003|Baseline|Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817641|NCT00006604|BG004|Baseline|Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817642|NCT00006604|BG005|Baseline|Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
10817643|NCT00006604|BG006|Baseline|Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
10817644|NCT00006604|BG007|Baseline|Total|Total of all reporting groups
10817645|NCT00006604|FG000|Participant Flow|Group 1: ATV Dose: Powder (310mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
10817646|NCT00006604|FG001|Participant Flow|Group 1: ATV Dose: Powder (620mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
10817647|NCT00006604|FG002|Participant Flow|Group 2: ATV Powder (310mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
10817648|NCT00006604|FG003|Participant Flow|Group 2: ATV Powder (620mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
10817649|NCT00006604|FG004|Participant Flow|Group 3: ATV Capsule (310mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs.
10817650|NCT00006604|FG005|Participant Flow|Group 3: ATV Capsule (415mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
10817651|NCT00006604|FG006|Participant Flow|Group 3: ATV Capsule (520mg/m^2)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
10817652|NCT00006604|FG007|Participant Flow|Group 4: ATV Capsule (310mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
10817653|NCT00006604|FG008|Participant Flow|Group 4: ATV Capsule (520mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
10817654|NCT00006604|FG009|Participant Flow|Group 4: ATV Capsule (620mg/m^2)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
10817655|NCT00006604|FG010|Participant Flow|Group 5: ATV Powder (310mg/m^2) + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
10817656|NCT00006604|FG011|Participant Flow|Group 5a: ATV Powder (310mg/m^2) + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
10817657|NCT00006604|FG012|Participant Flow|Group 6: ATV Powder (310mg/m^2) + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
10817658|NCT00006604|FG013|Participant Flow|Group 7: ATV Capsule (310mg/m^2) + RTV|Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
10817659|NCT00006604|FG014|Participant Flow|Group 7: ATV Capsule (205mg/m^2) + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
10817660|NCT00006604|FG015|Participant Flow|Group 8: ATV Capsule (310mg/m^2) + RTV|Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
10817661|NCT00006604|FG016|Participant Flow|Group 8: ATV Capsule (205mg/m^2) + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
10817662|NCT00006604|OG000|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
10817663|NCT00006604|OG001|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
10817664|NCT00006604|OG002|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817665|NCT00006604|OG003|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
10817666|NCT00006604|OG004|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817667|NCT00006604|OG005|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
10817668|NCT00006604|OG006|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
10817669|NCT00006604|OG003|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817670|NCT00006604|OG004|Outcome|Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817671|NCT00006604|OG005|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
10817672|NCT00006604|OG002|Outcome|Step I: Group 5: ATV 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
10817673|NCT00006604|OG000|Outcome|Step I: Group 3: ATV Dose 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2 Capsule"
10817674|NCT00006604|OG002|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
10817675|NCT00006604|OG004|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m2"
10817676|NCT00006604|EG000|Reported Event|Group 3: ATV 520mg/m^2 Capsule|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
10817677|NCT00006604|EG001|Reported Event|Group 4: ATV 620mg/m^2 Capsule|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
10817678|NCT00006604|EG002|Reported Event|Group 5: ATV 310mg/m^2 Powder + RTV|"91 days to 2 years of age (less than or exactly 730 days.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
11206552|NCT02236988|BG000|Baseline|Group 1|"Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3"
11206553|NCT02236988|BG001|Baseline|Group 2|"Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6"
11206554|NCT02236988|BG002|Baseline|Group 3|"Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9"
11286178|NCT02885025|BG002|Baseline|Placebo Pill + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE."
10817679|NCT00006604|EG003|Reported Event|Group 6: ATV 310mg/m^2 Powder + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
10817680|NCT00006604|EG004|Reported Event|Group 7: ATV 205mg/m^2 Capsule + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
10817681|NCT00006604|EG005|Reported Event|Group 8: ATV 205mg/m^2 Capsule + RTV|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
10817682|NCT00006604|EG006|Reported Event|Group 5A: ATV 310mg/m^2 Powder + RTV|"91 to 180 days of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
10817683|NCT00006721|BG000|Baseline|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
10817684|NCT00006721|BG001|Baseline|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
10817685|NCT00006721|BG002|Baseline|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
10817686|NCT00006721|BG003|Baseline|Total|Total of all reporting groups
10817687|NCT00006721|FG000|Participant Flow|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
10817688|NCT00006721|FG001|Participant Flow|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
10817689|NCT00006721|FG002|Participant Flow|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
10817690|NCT00006721|OG000|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
10817691|NCT00006721|OG001|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
10817692|NCT00006721|OG000|Outcome|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the abs ence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
10817693|NCT00006721|OG001|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
10817694|NCT00006721|OG002|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
10817695|NCT00006721|EG000|Reported Event|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
10817696|NCT00006721|EG001|Reported Event|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
10817697|NCT00006721|EG002|Reported Event|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
10817698|NCT00006903|BG000|Baseline|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817699|NCT00006903|BG001|Baseline|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817700|NCT00006903|BG002|Baseline|Total|Total of all reporting groups
11206555|NCT02236988|BG003|Baseline|Group 4|"Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14"
11206556|NCT02236988|BG004|Baseline|Total|Total of all reporting groups
11206557|NCT02236988|FG000|Participant Flow|Group 1|"Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3"
11206558|NCT02236988|FG001|Participant Flow|Group 2|"Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6"
10817701|NCT00006903|FG000|Participant Flow|Ineligible|Not eligible
10817702|NCT00006903|FG001|Participant Flow|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817703|NCT00006903|FG002|Participant Flow|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817704|NCT00006903|OG000|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817705|NCT00006903|OG001|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
10817706|NCT00006903|OG000|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10817707|NCT00006903|OG001|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10817708|NCT00006903|OG002|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10817709|NCT00006903|EG000|Reported Event|Faslodex|"Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.~Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants."
10817710|NCT00007020|BG000|Baseline|Cholic Acid|All patients entered into the study
11206559|NCT02236988|FG002|Participant Flow|Group 3|"Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9"
11206560|NCT02236988|FG003|Participant Flow|Group 4|"Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14"
11206561|NCT02236988|OG000|Outcome|Group 1: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
10817711|NCT00007020|FG000|Participant Flow|Cholic Acid|Cholic acid capsules, each containing 250 mg of cholic acid, or a liquid preparation of 15 mg/mL cholic acid, to be administered orally in a dose of 15 mg/kg body weight/day.
10817712|NCT00007020|OG000|Outcome|Cholic Acid|Patients treated
10817713|NCT00007020|OG000|Outcome|Cholic Acid|All patients entered into the study
10817714|NCT00007020|OG000|Outcome|Cholic Acid|All patients entered into the study and treated
10817715|NCT00007020|EG000|Reported Event|Cholic Acid|All patients entered into the study and treated with Cholic Acid. 85 patients enrolled in the study and 79 received treatment (safety set).
10817716|NCT00007345|BG000|Baseline|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817717|NCT00007345|BG001|Baseline|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817718|NCT00007345|BG002|Baseline|Total|Total of all reporting groups
10817719|NCT00007345|FG000|Participant Flow|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817720|NCT00007345|FG001|Participant Flow|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817721|NCT00007345|OG000|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817722|NCT00007345|OG001|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817723|NCT00007345|EG000|Reported Event|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817724|NCT00007345|EG001|Reported Event|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
10817725|NCT00007475|BG000|Baseline|FPF NOT Assayed Provisionally, PE + Cyclophosphamide Completed|Participants not provisionally assayed for FPF, yet still complete both series of protocol treatment: Plasma Exchange (PE) and Cyclophosphamide; note that these form a majority of enrollees due to limited availability of validated FPF assay (such an assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial; see Outcome Measures for more details)
10817726|NCT00007475|BG001|Baseline|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
10817727|NCT00007475|BG002|Baseline|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of validated FPF assay
10817728|NCT00007475|BG003|Baseline|Total|Total of all reporting groups
10817729|NCT00007475|FG000|Participant Flow|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants not assayed for FSGS Permeability Factor (FPF) levels pre-treatment (Tx), yet still complete both series of protocol-specified treatment; FPF levels NOT available as its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial
10817730|NCT00007475|FG001|Participant Flow|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
10817731|NCT00007475|FG002|Participant Flow|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
10817732|NCT00007475|FG003|Participant Flow|Historical Controls|Noted as Group F in study protocol: historical control patients, including patients at NIH or other institutions who have previously undergone renal transplant, for whom stored sera are available, and for whom consent to measure FPF has been can be obtained. In some cases, these measurements have been performed by Dr. Savin under pre-existing protocols and these data are already available.
10817733|NCT00007475|OG000|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment, Plasma Exchange and Cyclophosphamide.
10817734|NCT00007475|OG001|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
10817735|NCT00007475|OG002|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
10817736|NCT00007475|OG000|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment: Plasma Exchange + Cyclophosphamide
10817737|NCT00007475|OG000|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
10817738|NCT00007475|EG000|Reported Event|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants for whom the Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor, or FPF was not able to be assayed, yet enrolled and completed both protocol-specified interventions: the plasma exchange procedure and treatment by cyclophosphamide.
10817739|NCT00007475|EG001|Reported Event|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Original protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
10817740|NCT00007475|EG002|Reported Event|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Original protocol Group D (FPF 0.6 or greater pre-initial Transplant)
10817741|NCT00007644|BG000|Baseline|Radical Prostatectomy|Surgical removal of the prostate
10817742|NCT00007644|BG001|Baseline|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
10817743|NCT00007644|BG002|Baseline|Total|Total of all reporting groups
10817744|NCT00007644|FG000|Participant Flow|Radical Prostatectomy|Surgical removal of the prostate
10817745|NCT00007644|FG001|Participant Flow|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
10817746|NCT00007644|OG000|Outcome|Radical Prostatectomy|"Surgical removal of the prostate~Radical prostatectomy: Surgical removal of the prostate"
10817747|NCT00007644|OG001|Outcome|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
10817748|NCT00007644|EG000|Reported Event|Radical Prostatectomy|Surgical removal of the prostate
10817749|NCT00007644|EG001|Reported Event|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
10817750|NCT00008138|BG000|Baseline|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
10817751|NCT00008138|FG000|Participant Flow|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
10817752|NCT00008138|OG000|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
10817753|NCT00008138|EG000|Reported Event|Neoadjuvant Paclitaxel (IV) + Carboplatin (V)|Pre-surgery IV chemotherapy with paclitaxel and carboplatin
10817754|NCT00008138|EG001|Reported Event|Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)|post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
10817755|NCT00008385|BG000|Baseline|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
10967903|NCT00895895|EG000|Reported Event|Placebo/5.0 mg Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967904|NCT00895895|EG001|Reported Event|SAM-531 1.5 mg Period 1|SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967905|NCT00895895|EG002|Reported Event|SAM-531 3.0 mg Period 1|SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967906|NCT00895895|EG003|Reported Event|SAM-531 5.0 mg Period 1|SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967907|NCT00895895|EG004|Reported Event|Donepezil Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion and according to tolerance.
10967908|NCT00895895|EG005|Reported Event|SAM-531 5.0 mg Crossover Period 2|Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967909|NCT00895895|EG006|Reported Event|SAM-531 1.5 mg Period 2|SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967910|NCT00895895|EG007|Reported Event|SAM-531 3.0 mg Period 2|SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967911|NCT00895895|EG008|Reported Event|SAM-531 5.0 mg Period 2|SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
10967912|NCT00895895|EG009|Reported Event|Donepezil Period 2|Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion and according to tolerance.
10967913|NCT00895921|BG000|Baseline|Aripiprazole|"Participants will receive an injection of aripiprazole during the tracer-clamp study.~Aripiprazole: Single intramuscular 9.75-mg dose"
10967914|NCT00895921|BG001|Baseline|Olanzapine|"Participants will receive an injection of olanzapine during the tracer-clamp study.~Olanzapine: Single intramuscular 10-mg dose"
10967915|NCT00895921|BG002|Baseline|Total|Total of all reporting groups
10967916|NCT00895921|FG000|Participant Flow|Aripiprazole|"Participants will receive an injection of aripiprazole during the trace-clamp study.~Aripiprazole: Single intramuscular 9.75-mg dose"
10967917|NCT00895921|FG001|Participant Flow|Olanzapine|"Participants will receive an injection of olanzapine during the trace-clamp study.~Olanzapine: Single intramuscular 10-mg dose"
10967918|NCT00895921|OG000|Outcome|Aripiprazole|"Participants will receive an injection of aripiprazole during the tracer-clamp study.~Aripiprazole: Single intramuscular 9.75-mg dose"
10967919|NCT00895921|OG001|Outcome|Olanzapine|"Participants will receive an injection of olanzapine during the tracer-clamp study.~Olanzapine: Single intramuscular 10-mg dose"
10967920|NCT00895921|EG000|Reported Event|Aripiprazole|"Participants will receive an injection of aripiprazole during the tracer-clamp study.~Aripiprazole: Single intramuscular 9.75-mg dose"
10967921|NCT00895921|EG001|Reported Event|Olanzapine|"Participants will receive an injection of olanzapine during the tracer-clamp study.~Olanzapine: Single intramuscular 10-mg dose"
11206562|NCT02236988|OG001|Outcome|Group 1: Apremilast Modified Release 1|Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
10967922|NCT00895934|BG000|Baseline|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
10967923|NCT00895934|BG001|Baseline|Phase 2/Selected Dose|Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10967924|NCT00895934|BG002|Baseline|Total|Total of all reporting groups
10967925|NCT00895934|FG000|Participant Flow|Dose Level 1|"Azacitidine 75mg/m^2/day, days 1-7, Vorinostat 200mg/day, days 1-9; and Gemtuzumab Ozogamicin 3mg/m^2, Day 8 only. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Vorinostat: Given orally~Gemtuzumab ozogamicin: Given IV~Azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
11206563|NCT02236988|OG002|Outcome|Group 1: Apremilast Modified Release 2|Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
10967926|NCT00895934|FG001|Participant Flow|Dose Level 2|"Patients receive Azacitidine 75mg/m^2/day, days 1-7, Vorinostat 300mg/day, days 1-9; and Gemtuzumab Ozogamicin 3mg/m^2, Day 8 only. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Vorinostat: Given orally~Gemtuzumab ozogamicin: Given IV~Azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
10967927|NCT00895934|FG002|Participant Flow|Dose Level 3|"Patients receive Azacitidine 75mg/m^2/day, days 1-7, Vorinostat 400mg/day, days 1-9; and Gemtuzumab Ozogamicin 3mg/m^2, Day 8 only. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Vorinostat: Given orally~Gemtuzumab ozogamicin: Given IV~Azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
10967928|NCT00895934|FG003|Participant Flow|Dose Level 4|"Patients receive Azacitidine 75mg/m^2/day, days 1-7, Vorinostat 400 mg/day, days 1-9; and Gemtuzumab Ozogamicin 3mg/m^2, Days 4 and 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Vorinostat: Given orally~Gemtuzumab ozogamicin: Given IV~Azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
10967929|NCT00895934|OG000|Outcome|Dose 1|Vorinostat 200, D8
10967930|NCT00895934|OG001|Outcome|Dose 2|Vorinostat 300, D8
10967931|NCT00895934|OG002|Outcome|Dose 3|Vorinostat 400, D8
10967932|NCT00895934|OG003|Outcome|Dose 4|Vorinostat 400, D4 and D8
10967933|NCT00895934|OG000|Outcome|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
10967934|NCT00895934|OG001|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
10967935|NCT00895934|OG000|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
10967936|NCT00895934|EG000|Reported Event|Phase 1 Dose-Finding|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: correlative studies"
10967937|NCT00895934|EG001|Reported Event|Phase 2|"Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.~Laboratory biomarker analysis: correlative studies"
10967938|NCT00895947|BG000|Baseline|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
10967939|NCT00895947|BG001|Baseline|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
10967940|NCT00895947|BG002|Baseline|Total|Total of all reporting groups
10967941|NCT00895947|FG000|Participant Flow|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
10967942|NCT00895947|FG001|Participant Flow|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
10967943|NCT00895947|OG000|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
10967944|NCT00895947|OG001|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
10967945|NCT00895947|EG000|Reported Event|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
10967946|NCT00895947|EG001|Reported Event|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
10967947|NCT00896012|BG000|Baseline|1. Low-dose Tacrolimus Arm|Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months). All patients will undergo a second protocol biopsy at 12 months.
10967948|NCT00896012|BG001|Baseline|2. Rapamune Conversion Arm:|Patients in this group will undergo a gradual conversion from tacrolimus to Rapamune therapy. Tacrolimus will be withdrawn progressively over a period of 7-10 days. Dosage adjustments will be made with the aim of reducing the blood levels of tacrolimus by 25% every other day until tacrolimus is discontinued. Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
10967949|NCT00896012|BG002|Baseline|Total|Total of all reporting groups
10967950|NCT00896012|FG000|Participant Flow|1. Low-dose Tacrolimus Arm|Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months). All patients will undergo a second protocol biopsy at 12 months.
10967951|NCT00896012|FG001|Participant Flow|2. Rapamune Conversion Arm:|Patients in this group will undergo a gradual conversion from tacrolimus to Rapamune therapy. Tacrolimus will be withdrawn progressively over a period of 7-10 days. Dosage adjustments will be made with the aim of reducing the blood levels of tacrolimus by 25% every other day until tacrolimus is discontinued. Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
10967952|NCT00896012|OG000|Outcome|1. Low-dose Tacrolimus Arm|Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months). All patients will undergo a second protocol biopsy at 12 months.
10967953|NCT00896012|OG001|Outcome|2. Rapamune Conversion Arm:|Patients in this group will undergo a gradual conversion from tacrolimus to Rapamune therapy. Tacrolimus will be withdrawn progressively over a period of 7-10 days. Dosage adjustments will be made with the aim of reducing the blood levels of tacrolimus by 25% every other day until tacrolimus is discontinued. Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
10967954|NCT00896012|EG000|Reported Event|1. Low-dose Tacrolimus Arm|Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months). All patients will undergo a second protocol biopsy at 12 months.
10967955|NCT00896012|EG001|Reported Event|2. Rapamune Conversion Arm:|Patients in this group will undergo a gradual conversion from tacrolimus to Rapamune therapy. Tacrolimus will be withdrawn progressively over a period of 7-10 days. Dosage adjustments will be made with the aim of reducing the blood levels of tacrolimus by 25% every other day until tacrolimus is discontinued. Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
10967956|NCT00896038|BG000|Baseline|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
10967957|NCT00896038|BG001|Baseline|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
10967958|NCT00896038|BG002|Baseline|Total|Total of all reporting groups
10967959|NCT00896038|FG000|Participant Flow|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
10967960|NCT00896038|FG001|Participant Flow|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
10967961|NCT00896038|OG000|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
10967962|NCT00896038|OG001|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
10967963|NCT00896038|EG000|Reported Event|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
10967964|NCT00896038|EG001|Reported Event|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
10967965|NCT00896051|BG000|Baseline|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
10967966|NCT00896051|BG001|Baseline|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
10967967|NCT00896051|BG002|Baseline|Total|Total of all reporting groups
10967968|NCT00896051|FG000|Participant Flow|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
10967969|NCT00896051|FG001|Participant Flow|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
11206564|NCT02236988|OG003|Outcome|Group 1: Apremilast Modified Release 3|Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
10967970|NCT00896051|OG000|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
10967971|NCT00896051|OG001|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
10967972|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
10967973|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
10967974|NCT00896051|OG000|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
11206565|NCT02236988|OG000|Outcome|Group 1: Apremilast Modified Release 1|Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
11206566|NCT02236988|OG001|Outcome|Group 1: Apremilast Modified Release 2|Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
10967975|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
10967976|NCT00896051|OG000|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
10967977|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
10967978|NCT00896051|OG000|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
10967979|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
10967980|NCT00896051|OG001|Outcome|ATV/Rtv 400/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
10967981|NCT00896051|EG000|Reported Event|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
10967982|NCT00896051|EG001|Reported Event|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
10967983|NCT00896064|BG000|Baseline|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967984|NCT00896064|BG001|Baseline|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967985|NCT00896064|BG002|Baseline|Total|Total of all reporting groups
10967986|NCT00896064|FG000|Participant Flow|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967987|NCT00896064|FG001|Participant Flow|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967988|NCT00896064|OG000|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967989|NCT00896064|OG001|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967990|NCT00896064|EG000|Reported Event|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967991|NCT00896064|EG001|Reported Event|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
10967992|NCT00896168|BG000|Baseline|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
10967993|NCT00896168|BG001|Baseline|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
10967994|NCT00896168|BG002|Baseline|Total|Total of all reporting groups
10967995|NCT00896168|FG000|Participant Flow|Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA])|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
10967996|NCT00896168|FG001|Participant Flow|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
10967997|NCT00896168|OG000|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
10967998|NCT00896168|OG001|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
10967999|NCT00896168|EG000|Reported Event|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
10968000|NCT00896168|EG001|Reported Event|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
10968001|NCT00896181|BG000|Baseline|Chemoradiation for Nasopharyngeal Carcinoma|"Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly.~The total treatment course is up to 21 weeks."
10968002|NCT00896181|FG000|Participant Flow|Chemoradiation for Nasopharyngeal Carcinoma|"Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly.~The total treatment course is up to 21 weeks."
10968003|NCT00896181|OG000|Outcome|Chemoradiation for Nasopharyngeal Carcinoma|"Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly.~The total treatment course is up to 21 weeks."
10968004|NCT00896181|EG000|Reported Event|Chemoradiation for Nasopharyngeal Carcinoma|"Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly.~The total treatment course is up to 21 weeks."
11206567|NCT02236988|OG002|Outcome|Group 1: Apremilast Modified Release 3|Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
10968005|NCT00896233|BG000|Baseline|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
10968006|NCT00896233|FG000|Participant Flow|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
10968007|NCT00896233|OG000|Outcome|Reader 1|Participant scans evaluated by Reader 1.
10968008|NCT00896233|OG001|Outcome|Reader 2|Participant scans evaluated by Reader 2.
10968009|NCT00896233|EG000|Reported Event|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
10968010|NCT00896298|BG000|Baseline|Leptin Therapy|Participants were randomized to receive Leptin .
10968011|NCT00896298|BG001|Baseline|Placebo|Participants were randomized to receive Placebo .
10968012|NCT00896298|BG002|Baseline|Total|Total of all reporting groups
10968013|NCT00896298|FG000|Participant Flow|Leptin Therapy|Randomized to Leptin Therapy for 4 months.
10968014|NCT00896298|FG001|Participant Flow|Placebo|Randomized to Placebo for 4 months.
10968015|NCT00896298|OG000|Outcome|Leptin Therapy|Randomized to Leptin Therapy for 4 months.
10968016|NCT00896298|OG001|Outcome|Placebo|Randomized to Placebo for 4 months.
10968017|NCT00896298|EG000|Reported Event|Leptin Therapy|Randomized to Leptin Therapy for 4 months.
10968018|NCT00896298|EG001|Reported Event|Placebo|Randomized to Placebo for 4 months.
10968019|NCT00896337|BG000|Baseline|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
10968020|NCT00896337|FG000|Participant Flow|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
10968021|NCT00896337|OG000|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
10968022|NCT00896337|OG000|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
10968023|NCT00896337|OG000|Outcome|Epis Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
10968024|NCT00896337|OG000|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
10968025|NCT00896337|OG000|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
10968026|NCT00896337|OG000|Outcome|Epic Stent|Participants who received the Epic Stent
11206568|NCT02236988|OG000|Outcome|Group 2: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
10817756|NCT00008385|BG001|Baseline|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
10817757|NCT00008385|BG002|Baseline|Total|Total of all reporting groups
10817758|NCT00008385|FG000|Participant Flow|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
10817759|NCT00008385|FG001|Participant Flow|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
10817760|NCT00008385|OG000|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
10817761|NCT00008385|OG001|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
10817762|NCT00008385|EG000|Reported Event|Arm I (Placebo)|Participants receive an oral yeast placebo as in arm II. placebo: Given orally
10817763|NCT00008385|EG001|Reported Event|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
10817764|NCT00009737|BG000|Baseline|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
10817765|NCT00009737|BG001|Baseline|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
10817766|NCT00009737|BG002|Baseline|Total|Total of all reporting groups
10817767|NCT00009737|FG000|Participant Flow|Capecitabine|Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
10817768|NCT00009737|FG001|Participant Flow|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
10817769|NCT00009737|OG000|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
10817770|NCT00009737|OG001|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
10817771|NCT00009737|EG000|Reported Event|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
10817772|NCT00009737|EG001|Reported Event|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
10817773|NCT00009945|BG000|Baseline|Clodronate|Clodronate
10817774|NCT00009945|BG001|Baseline|Placebo|Placebo
10817775|NCT00009945|BG002|Baseline|Total|Total of all reporting groups
10817776|NCT00009945|FG000|Participant Flow|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
10817777|NCT00009945|FG001|Participant Flow|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
10817778|NCT00009945|OG000|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
10817779|NCT00009945|OG001|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
10817780|NCT00009945|EG000|Reported Event|Clodronate|Clodronate
10817781|NCT00009945|EG001|Reported Event|Placebo|Placebo
10817782|NCT00010257|BG000|Baseline|Thymoma|Patients with diagnosis of thymoma
10817783|NCT00010257|BG001|Baseline|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
10817784|NCT00010257|BG002|Baseline|Total|Total of all reporting groups
10817785|NCT00010257|FG000|Participant Flow|Thymoma|Patients with diagnosis of thymoma
10817786|NCT00010257|FG001|Participant Flow|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
10817787|NCT00010257|OG000|Outcome|Thymoma|Patients with diagnosis of thymoma
10817788|NCT00010257|OG001|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
10817789|NCT00010257|EG000|Reported Event|Thymoma|Patients with diagnosis of thymoma
10817790|NCT00010257|EG001|Reported Event|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
10817791|NCT00010374|BG000|Baseline|NeuRx DPS|"Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.~NeuRx DPS: Laparoscopic implantation of diprapagm electrode and subsequent pacing with the NeuRx DPS."
10817792|NCT00010374|FG000|Participant Flow|Treatment|Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
10817793|NCT00010374|OG000|Outcome|Treatment|Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
10817794|NCT00010374|OG000|Outcome|NeuRx Implanted Patients|SCI patients who received NeuRx DPS implants
10817795|NCT00010374|EG000|Reported Event|Treatment|Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
10817796|NCT00010439|BG000|Baseline|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
10817797|NCT00010439|FG000|Participant Flow|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
10817798|NCT00010439|OG000|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
11206569|NCT02236988|OG001|Outcome|Group 2: Apremilast Modified Release 4|Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
11206570|NCT02236988|OG002|Outcome|Group 2: Apremilast Modified Release 5|Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
11206571|NCT02236988|OG003|Outcome|Group 2: Apremilast Modified Release 6|Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
10817799|NCT00010439|EG000|Reported Event|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
10817800|NCT00010803|BG000|Baseline|Ginkgo Biloba|120 mg twice daily, total 240 mg
10817801|NCT00010803|BG001|Baseline|Placebo|Placebo 1 pill twice daily
10817802|NCT00010803|BG002|Baseline|Total|Total of all reporting groups
10817803|NCT00010803|FG000|Participant Flow|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
10817804|NCT00010803|FG001|Participant Flow|Placebo|Placebo twice daily
10817805|NCT00010803|OG000|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
10817806|NCT00010803|OG001|Outcome|Placebo|Placebo 1 pill twice a day
11206572|NCT02236988|OG000|Outcome|Group 2: Apremilast Modified Release 4|Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
10817807|NCT00010803|EG000|Reported Event|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
10817808|NCT00010803|EG001|Reported Event|Placebo|Placebo twice daily
10817809|NCT00011986|BG000|Baseline|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
10817810|NCT00011986|BG001|Baseline|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
10817811|NCT00011986|BG002|Baseline|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
10817812|NCT00011986|BG003|Baseline|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817813|NCT00011986|BG004|Baseline|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817814|NCT00011986|BG005|Baseline|Total|Total of all reporting groups
11206573|NCT02236988|OG001|Outcome|Group 2: Apremilast Modified Release 5|Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
10817815|NCT00011986|FG000|Participant Flow|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
10817816|NCT00011986|FG001|Participant Flow|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
10817817|NCT00011986|FG002|Participant Flow|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
10817818|NCT00011986|FG003|Participant Flow|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817819|NCT00011986|FG004|Participant Flow|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817820|NCT00011986|OG000|Outcome|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
10817821|NCT00011986|OG001|Outcome|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
10817822|NCT00011986|OG002|Outcome|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
10817823|NCT00011986|OG003|Outcome|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817824|NCT00011986|OG004|Outcome|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817825|NCT00011986|OG000|Outcome|Grade 3 and Above on ToxicityCarbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
10817826|NCT00011986|OG001|Outcome|Grade 3 and Above on Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
10817827|NCT00011986|OG002|Outcome|Grade 3 and Above on Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
10817828|NCT00011986|OG003|Outcome|Grade 3 and Above on Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817829|NCT00011986|OG004|Outcome|Grade 3 and Above on Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817830|NCT00011986|EG000|Reported Event|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
10817831|NCT00011986|EG001|Reported Event|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
11206574|NCT02236988|OG002|Outcome|Group 2: Apremilast Modified Release 6|Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
11206575|NCT02236988|OG000|Outcome|Group 3: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
11206576|NCT02236988|OG001|Outcome|Group 3: Apremilast Modified Release 8|Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
11206577|NCT02236988|OG002|Outcome|Group 3: Apremilast Modified Release 9|Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
10968027|NCT00896337|EG000|Reported Event|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
10968028|NCT00896363|BG000|Baseline|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
10968029|NCT00896363|BG001|Baseline|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
10968030|NCT00896363|BG002|Baseline|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
10968031|NCT00896363|BG003|Baseline|Total|Total of all reporting groups
10968032|NCT00896363|FG000|Participant Flow|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet in the morning (AM) and one taken between 11 to 13 hours after the AM dose in the evening (PM) for 6 weeks.
10968033|NCT00896363|FG001|Participant Flow|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 milligram (mg) immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards
10968034|NCT00896363|FG002|Participant Flow|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
10968035|NCT00896363|OG000|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
10968036|NCT00896363|OG001|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
10968037|NCT00896363|OG002|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
10968038|NCT00896363|OG000|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks
10968039|NCT00896363|OG000|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
10968040|NCT00896363|OG001|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
10968041|NCT00896363|EG000|Reported Event|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
11206578|NCT02236988|OG000|Outcome|Group 3: Apremilast Modified Release 8|Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
11206579|NCT02236988|OG001|Outcome|Group 3: Apremilast Modified Release 9|Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
11206580|NCT02236988|OG000|Outcome|Group 4: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
11206581|NCT02236988|OG001|Outcome|Group 4: Apremilast Modified Release 11|Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
11206582|NCT02236988|OG002|Outcome|Group 4: Apremilast Modified Release 12|Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
11206583|NCT02236988|OG003|Outcome|Group 4: Apremilast Modified Release 13|Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
10817832|NCT00011986|EG002|Reported Event|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
10817833|NCT00011986|EG003|Reported Event|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817834|NCT00011986|EG004|Reported Event|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
10817835|NCT00012012|BG000|Baseline|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
10817836|NCT00012012|BG001|Baseline|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
10817837|NCT00012012|BG002|Baseline|Total|Total of all reporting groups
10817838|NCT00012012|FG000|Participant Flow|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
10817839|NCT00012012|FG001|Participant Flow|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
10817840|NCT00012012|OG000|Outcome|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
10817841|NCT00012012|OG000|Outcome|Radiation Therapy Plus Cisplatin and Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
10817842|NCT00012012|EG000|Reported Event|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
10817843|NCT00012012|EG001|Reported Event|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
10817844|NCT00012298|BG000|Baseline|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
10817845|NCT00012298|BG001|Baseline|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
10817846|NCT00012298|BG002|Baseline|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817847|NCT00012298|BG003|Baseline|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817848|NCT00012298|BG004|Baseline|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817849|NCT00012298|BG005|Baseline|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817850|NCT00012298|BG006|Baseline|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817851|NCT00012298|BG007|Baseline|Total|Total of all reporting groups
10817852|NCT00012298|FG000|Participant Flow|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
10817853|NCT00012298|FG001|Participant Flow|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
10817854|NCT00012298|FG002|Participant Flow|Treatment: Trial 2, Dose Level 3|"Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817855|NCT00012298|FG003|Participant Flow|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817856|NCT00012298|FG004|Participant Flow|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817857|NCT00012298|FG005|Participant Flow|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817858|NCT00012298|FG006|Participant Flow|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817859|NCT00012298|OG000|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
10817860|NCT00012298|OG001|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
10822057|NCT00074269|OG000|Outcome|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
10822058|NCT00074269|OG000|Outcome|Treatment|patients treated on protocol
10968042|NCT00896363|EG001|Reported Event|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg).from Day 2 onwards.
10968043|NCT00896363|EG002|Reported Event|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
10968044|NCT00896441|BG000|Baseline|Depressed|Depressed individuals
10968045|NCT00896441|BG001|Baseline|Healthy Controls|Participants with no history of psychiatric illness
10968046|NCT00896441|BG002|Baseline|Total|Total of all reporting groups
10968047|NCT00896441|FG000|Participant Flow|Depressed|Depressed individuals
10968048|NCT00896441|FG001|Participant Flow|Healthy Controls|Participants with no history of psychiatric illness
10968049|NCT00896441|OG000|Outcome|Depressed|Depressed individuals
10968050|NCT00896441|EG000|Reported Event|Depressed|Depressed individuals
10968051|NCT00896441|EG001|Reported Event|Healthy Controls|Participants with no history of psychiatric illness
10968052|NCT00896454|BG000|Baseline|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
10968053|NCT00896454|FG000|Participant Flow|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
10968054|NCT00896454|OG000|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
10968055|NCT00896454|EG000|Reported Event|Denosumab 120 mg Q4W|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
10968056|NCT00896480|BG000|Baseline|GSK2132231A Group|Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
10968057|NCT00896480|FG000|Participant Flow|GSK2132231A Group|Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
10968058|NCT00896480|OG000|Outcome|GSK2132231A GS+/+ Group|Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
10968059|NCT00896480|OG001|Outcome|GSK2132231A GS+/- Group|Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
10968060|NCT00896480|OG002|Outcome|GSK2132231A GS- Group|Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
10968061|NCT00896480|OG000|Outcome|GSK2132231A Group|Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
10968062|NCT00896480|EG000|Reported Event|GSK2132231A Group|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A (the study product), in 4 cycles.
10968063|NCT00896532|BG000|Baseline|Placebo|Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.
10968064|NCT00896532|BG001|Baseline|Alendronate|Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).
10968065|NCT00896532|BG002|Baseline|Teriparatide|Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.
10968066|NCT00896532|BG003|Baseline|Romosozumab 70 mg QM|Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.
10968067|NCT00896532|BG004|Baseline|Romosozumab 140 mg Q3M|Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.
10968068|NCT00896532|BG005|Baseline|Romosozumab 140 mg QM|Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.
10968069|NCT00896532|BG006|Baseline|Romosozumab 210 mg Q3M|Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.
10968070|NCT00896532|BG007|Baseline|Romosozumab 210 mg QM|Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
10968071|NCT00896532|BG008|Baseline|Total|Total of all reporting groups
10968072|NCT00896532|FG000|Participant Flow|Placebo|Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.
10968073|NCT00896532|FG001|Participant Flow|Alendronate|Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).
10822059|NCT00074269|EG000|Reported Event|Treatment|"The events monitored in the treatment arm of the protocol are listed below:~incidence of Toxicity~administration of filgrastim~Grade of GVHD~Initiation of graft-versus-tumor induction therapy~Disease Status"
10968074|NCT00896532|FG002|Participant Flow|Teriparatide|Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.
10968075|NCT00896532|FG003|Participant Flow|Romosozumab 70 mg QM|Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.
10968076|NCT00896532|FG004|Participant Flow|Romosozumab 140 mg Q3M|Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.
10968077|NCT00896532|FG005|Participant Flow|Romosozumab 140 mg QM|Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.
10968078|NCT00896532|FG006|Participant Flow|Romosozumab 210 mg Q3M|Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.
10968079|NCT00896532|FG007|Participant Flow|Romosozumab 210 mg QM|Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
10968080|NCT00896532|FG008|Participant Flow|Month 24-36: Placebo/Placebo|Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months (Q6M) for 12 months during the denosumab extension phase.
10968081|NCT00896532|FG009|Participant Flow|Month 24-36: Placebo/Denosumab|Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968082|NCT00896532|FG010|Participant Flow|Month 24-36: Alendronate/Romosozumab/Placebo|Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968083|NCT00896532|FG011|Participant Flow|Month 24-36: Alendronate/Romosozumab/Denosumab|Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously QM from months 12 to 24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968084|NCT00896532|FG012|Participant Flow|Month 24-36: Romosozumab/Placebo|Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968085|NCT00896532|FG013|Participant Flow|Month 24-36: Romosozumab/Denosumab|Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968086|NCT00896532|FG014|Participant Flow|Month 36-48: Placebo/Placebo/Romosozumab|Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24-36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968087|NCT00896532|FG015|Participant Flow|Month 36-48: Placebo/Denosumab/Romosozumab|Participants who received placebo in the first 24 month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968088|NCT00896532|FG016|Participant Flow|Month 36-48: Romosozumab/Placebo/Romosozumab|Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
11206584|NCT02236988|OG004|Outcome|Group 4: Apremilast Modified Release 14|Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
11206585|NCT02236988|OG000|Outcome|Group 4: Apremilast Modified Release 11|Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
11206586|NCT02236988|OG001|Outcome|Group 4: Apremilast Modified Release 12|Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
10968089|NCT00896532|FG017|Participant Flow|Month 36-48: Romosozumab/Denosumab/Romosozumab|Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968090|NCT00896532|FG018|Participant Flow|Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention|Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72).
10968091|NCT00896532|FG019|Participant Flow|Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid|Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968092|NCT00896532|FG020|Participant Flow|Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Acid|Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968093|NCT00896532|FG021|Participant Flow|Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid|Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
11206587|NCT02236988|OG002|Outcome|Group 4: Apremilast Modified Release 13|Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
11206588|NCT02236988|OG003|Outcome|Group 4: Apremilast Modified Release 14|Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
11206589|NCT02236988|EG000|Reported Event|Group 1: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
11206590|NCT02236988|EG001|Reported Event|Group 1: Apremilast Modified Release 1|Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
11206591|NCT02236988|EG002|Reported Event|Group 1: Apremilast Modified Release 2|Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
11206592|NCT02236988|EG003|Reported Event|Group 1: Apremilast Modified Release 3|Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
11206593|NCT02236988|EG004|Reported Event|Group 1 Total|"Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3."
11206594|NCT02236988|EG005|Reported Event|Group 2: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
10817861|NCT00012298|OG002|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817862|NCT00012298|OG003|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817863|NCT00012298|OG004|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817864|NCT00012298|OG005|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817865|NCT00012298|OG002|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
10817866|NCT00012298|OG000|Outcome|Treatment : Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
10817867|NCT00012298|OG000|Outcome|Treatment (Radiolabeled Monoclonal Antibody Therapy)|"Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.~rituximab: Given IV~yttrium Y 90 ibritumomab tiuxetan: Given IV~indium In 111 ibritumomab tiuxetan: Given IV~oprelvekin: Given subcutaneously~filgrastim: Given subcutaneously"
10817868|NCT00012298|EG000|Reported Event|Treatment: Trial 1, Dose Level 1|0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
10817869|NCT00012298|EG001|Reported Event|Treatment: Trial 1, Dose Level 2|0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
10817870|NCT00012298|EG002|Reported Event|Treatment: Trial 2, Dose Level 3|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
11206595|NCT02236988|EG006|Reported Event|Group 2: Apremilast Modified Release 4|Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
10817871|NCT00012298|EG003|Reported Event|Treatment: Trial 2, Dose Level 4|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
10817872|NCT00012298|EG004|Reported Event|Treatment: Trial 3, Dose Level 5|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
10817873|NCT00012298|EG005|Reported Event|Treatment: Trial 3, Dose Level 6|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
11206596|NCT02236988|EG007|Reported Event|Group 2: Apremilast Modified Release 5|Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
11206597|NCT02236988|EG008|Reported Event|Group 2: Apremilast Modified Release 6|Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
10817874|NCT00012298|EG006|Reported Event|Treatment : Phase II (Dose Level 6)|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
10817875|NCT00013611|BG000|Baseline|Proleukin Plus Antiretroviral Therapy|
10817876|NCT00013611|BG001|Baseline|Antiretroviral Therapy Only|
10817877|NCT00013611|BG002|Baseline|Total|Total of all reporting groups
10817878|NCT00013611|FG000|Participant Flow|Proleukin Plus Antiretroviral Therapy|Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
10817879|NCT00013611|FG001|Participant Flow|Antiretroviral Therapy Only|All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
10817880|NCT00013611|OG000|Outcome|Proleukin Plus Antiretroviral Therapy|
10817881|NCT00013611|OG001|Outcome|Antiretroviral Therapy Only|
10817882|NCT00013611|EG000|Reported Event|Proleukin Plus Antiretroviral Therapy|
10817883|NCT00013611|EG001|Reported Event|Antiretroviral Therapy Only|
10817884|NCT00014222|BG000|Baseline|Arm 1: CEF|"6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid~cyclophosphamide: 75, 600 and 830 mg/m2~epirubicin hydrochloride: 60 mg/m2~fluorouracil: 500mg/m2"
10817885|NCT00014222|BG001|Baseline|Arm 2: EC/T|"6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~epoetin alfa: 40,000 IU~filgrastim: 5 mg/kg/d - days 2-13~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817886|NCT00014222|BG002|Baseline|Arm 3: AC/T|"4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817887|NCT00014222|BG003|Baseline|Total|Total of all reporting groups
10817888|NCT00014222|FG000|Participant Flow|Arm 1: CEF|"6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid~cyclophosphamide: 75, 600 and 830 mg/m2~epirubicin hydrochloride: 60 mg/m2~fluorouracil: 500mg/m2"
10817889|NCT00014222|FG001|Participant Flow|Arm 2: EC/T|"6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~epoetin alfa: 40,000 IU~filgrastim: 5 mg/kg/d - days 2-13~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817890|NCT00014222|FG002|Participant Flow|Arm 3: AC/T|"4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817891|NCT00014222|OG000|Outcome|Arm 1: CEF|"6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid~cyclophosphamide: 75, 600 and 830 mg/m2~epirubicin hydrochloride: 60 mg/m2~fluorouracil: 500mg/m2"
10817892|NCT00014222|OG001|Outcome|Arm 2: EC/T|"6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~epoetin alfa: 40,000 IU~filgrastim: 5 mg/kg/d - days 2-13~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817893|NCT00014222|OG002|Outcome|Arm 3: AC/T|"4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817894|NCT00014222|EG000|Reported Event|Arm 1: CEF|"6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid~cyclophosphamide: 75, 600 and 830 mg/m2~epirubicin hydrochloride: 60 mg/m2~fluorouracil: 500mg/m2"
10968094|NCT00896532|FG022|Participant Flow|Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid|Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968095|NCT00896532|OG000|Outcome|Placebo|Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.
10968096|NCT00896532|OG001|Outcome|Alendronate|Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).
10968097|NCT00896532|OG002|Outcome|Teriparatide|Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.
10968098|NCT00896532|OG003|Outcome|Romosozumab 70 mg QM|Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.
10968099|NCT00896532|OG004|Outcome|Romosozumab 140 mg Q3M|Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.
10968100|NCT00896532|OG005|Outcome|Romosozumab 140 mg QM|Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.
10968101|NCT00896532|OG006|Outcome|Romosozumab 210 mg Q3M|Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.
10968102|NCT00896532|OG007|Outcome|Romosozumab 210 mg QM|Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
10968103|NCT00896532|OG008|Outcome|Romosozumab Monthly|Participants who received once a month dosing of romosozumab (70, 140 or 210 mg).
10968104|NCT00896532|OG009|Outcome|Romosozumab Every 3 Months|Participants who received romosozumab every 3 months (140 or 210 mg)
10968105|NCT00896532|OG010|Outcome|Romosozumab 140 mg|Participants who received romosozumab 140 mg dosing (QM or Q3M).
10968106|NCT00896532|OG011|Outcome|Romosozumab 210 mg|Participants who received romosozumab 210 mg dosing (QM or Q3M).
10968107|NCT00896532|EG000|Reported Event|BL-Month 12: Placebo QM|Participants received placebo matching to romosozumab once a month (QM) administered subcutaneously for 12 months.
10968108|NCT00896532|EG001|Reported Event|BL-Month 12: Placebo Q3M|Participants received placebo matching to romosozumab once every 3 months (Q3M) administered subcutaneously for 12 months.
10968109|NCT00896532|EG002|Reported Event|BL-Month 12: Alendronate|Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months.
10968110|NCT00896532|EG003|Reported Event|BL-Month12: Teriparatide|Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months.
10968111|NCT00896532|EG004|Reported Event|BL-Month 12: Romosozumab 70 mg QM|Participants received double-blind romosozumab 70 mg subcutaneously every month for 12 months.
10968112|NCT00896532|EG005|Reported Event|BL-Month 12: Romosozumab 140 mg Q3M|Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 12 months.
10968113|NCT00896532|EG006|Reported Event|BL-Month 12: Romosozumab 140 mg QM|Participants received double-blind romosozumab 140 mg subcutaneously every month for 12 months.
10968114|NCT00896532|EG007|Reported Event|BL-Month 12: Romosozumab 210 mg Q3M|Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 12 months.
10968115|NCT00896532|EG008|Reported Event|BL-Month 12: Romosozumab 210 mg QM|Participants received double-blind romosozumab 210 mg QM subcutaneously for 12 months.
10968116|NCT00896532|EG009|Reported Event|BL-Month 24: Placebo QM|Participants received placebo matching to romosozumab QM administered subcutaneously for 24 months.
10968117|NCT00896532|EG010|Reported Event|BL-Month 24: Placebo Q3M|Participants received placebo matching to romosozumab Q3M administered subcutaneously for 24 months.
10968118|NCT00896532|EG011|Reported Event|BL-Month 24: ALN/Romosozumab 140 mg QM|Participants received open-label alendronate (ALN) 70 mg PO QW for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).
10968119|NCT00896532|EG012|Reported Event|BL-Month 24: Romosozumab 70 mg QM|Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.
10968120|NCT00896532|EG013|Reported Event|BL-Month 24: Romosozumab 140 mg Q3M|Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.
10968121|NCT00896532|EG014|Reported Event|BL-Month 24: Romosozumab 140 mg QM|Participants received double-blind romosozumab 140 mg subcutaneously every month for 24 months.
10968122|NCT00896532|EG015|Reported Event|BL-Month 24: Romosozumab 210 mg Q3M|Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.
10968123|NCT00896532|EG016|Reported Event|BL-Month 24: Romosozumab 210 mg QM|Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
10968124|NCT00896532|EG017|Reported Event|Month 24-36: Placebo/Placebo|Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968125|NCT00896532|EG018|Reported Event|Month 24-36: Placebo/Denosumab|Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968126|NCT00896532|EG019|Reported Event|Month 24-36: ALN/Romosozumab/Placebo|Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968127|NCT00896532|EG020|Reported Event|Month 24-36: ALN/Romosozumab/Denosumab|Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously every month from months 12-24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968128|NCT00896532|EG021|Reported Event|Month 24-36: Romosozumab/Placebo|Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968129|NCT00896532|EG022|Reported Event|Month 24-36: Romosozumab/Denosumab|Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.
10968130|NCT00896532|EG023|Reported Event|Month 36-48: Placebo/Placebo/Romosozumab|Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968131|NCT00896532|EG024|Reported Event|Month 36-48: Placebo/Denosumab/Romosozumab|Participants who received placebo in the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968132|NCT00896532|EG025|Reported Event|Month 36-48: Romosozumab/Placebo/Romosozumab|Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968133|NCT00896532|EG026|Reported Event|Month 36-48: Romosozumab/Denosumab/Romosozumab|Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).
10968134|NCT00896532|EG027|Reported Event|Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention|Participants who received romosozumab at any dose during the first 24 month treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72).
10968135|NCT00896532|EG028|Reported Event|Month 48-72: Romosozumab/Placebo/Romosozumab/No|Participants who received romosozumab at any dose during the first 24 month treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 were assigned to the zoledronic acid treatment group, but received no intervention during the 24-month follow-on phase (months 48 to 72).
10968136|NCT00896532|EG029|Reported Event|Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid|Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
11206598|NCT02236988|EG009|Reported Event|Group 2 Total|"Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6"
11206599|NCT02236988|EG010|Reported Event|Group 3: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
11206600|NCT02236988|EG011|Reported Event|Group 3: Apremilast Modified Release 8|Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
11206601|NCT02236988|EG012|Reported Event|Group 3: Apremilast Modified Release 9|Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
11206602|NCT02236988|EG013|Reported Event|Group 3 Total|"Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9"
11206603|NCT02236988|EG014|Reported Event|Group 4: Apremilast Immediate Release|Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
11206604|NCT02236988|EG015|Reported Event|Group 4: Apremilast Modified Release 11|Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
10968137|NCT00896532|EG030|Reported Event|Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic|Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968138|NCT00896532|EG031|Reported Event|Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid|Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968139|NCT00896532|EG032|Reported Event|Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid|Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
10968140|NCT00896649|BG000|Baseline|Positron Emission Mammography (PEM), Mammography, Questionaire|"questionnaire administration digital mammography positron emission mammography~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~digital mammography: standard screening mammogram~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
11206605|NCT02236988|EG016|Reported Event|Group 4: Apremilast Modified Release 12|Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
11206606|NCT02236988|EG017|Reported Event|Group 4: Apremilast Modified Release 13|Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
11206607|NCT02236988|EG018|Reported Event|Group 4: Apremilast Modified Release 14|Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
11206608|NCT02236988|EG019|Reported Event|Group 4 Total|"Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:~A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14"
11206609|NCT02236988|EG020|Reported Event|Overall Total|All participants who received any dose of apremilast during the study.
11206610|NCT02237001|BG000|Baseline|Treatment|"Suture-based meniscal repair~Suture-based meniscal repair: Suture-based meniscal repair"
11206611|NCT02237001|FG000|Participant Flow|Treatment|"Suture-based meniscal repair~Suture-based meniscal repair: Suture-based meniscal repair"
11206612|NCT02237001|OG000|Outcome|Treatment|"Suture-based meniscal repair~Suture-based meniscal repair: Suture-based meniscal repair"
11206613|NCT02237001|EG000|Reported Event|Treatment|"Suture-based meniscal repair~Suture-based meniscal repair: Suture-based meniscal repair"
11206614|NCT02237092|BG000|Baseline|Measurement of IAP|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.
10817895|NCT00014222|EG001|Reported Event|Arm 2: EC/T|"6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~epoetin alfa: 40,000 IU~filgrastim: 5 mg/kg/d - days 2-13~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817896|NCT00014222|EG002|Reported Event|Arm 3: AC/T|"4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion~cyclophosphamide: 75, 600 and 830 mg/m2~doxorubicin hydrochloride: 60 mg/m2~paclitaxel: 175 mg/m2"
10817897|NCT00014495|BG000|Baseline|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817898|NCT00014495|BG001|Baseline|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817899|NCT00014495|BG002|Baseline|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817900|NCT00014495|BG003|Baseline|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817901|NCT00014495|BG004|Baseline|Total|Total of all reporting groups
10817902|NCT00014495|FG000|Participant Flow|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
11206615|NCT02237092|FG000|Participant Flow|Measurement of IAP|"The data obtained are in inches of water column were translated in millimeters of mercury.~Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration."
11206616|NCT02237092|OG000|Outcome|Intra-abdominal Pressure (IAP) in Pregnant Women|Average IAP in pregnant women
11206617|NCT02237092|OG000|Outcome|Physiological Norm|(≤11,99 mm Hg)
11206618|NCT02237092|OG001|Outcome|Grade I|(12 - 15.99 mm Hg)
11206619|NCT02237092|OG002|Outcome|Grade II|(16 - 20.99 mm Hg)
11206620|NCT02237092|OG003|Outcome|Grade III|(21 - 25.99 mm Hg)
11206621|NCT02237092|OG000|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
10968141|NCT00896649|FG000|Participant Flow|Single Arm Positron Emission Mamm, Mammogram and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
10968142|NCT00896649|OG000|Outcome|Single Arm Positron Emission Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
10968143|NCT00896649|OG000|Outcome|Single Arm Positron Emission Mammo, Mammogram & Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
10968144|NCT00896649|EG000|Reported Event|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
10968145|NCT00896779|BG000|Baseline|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
10968146|NCT00896779|BG001|Baseline|Ranibizumab Group 2|Group 2: 6 monthly injecions of 0.5mg then prn
11244378|NCT02510664|OG001|Outcome|Parent|"There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments"
10968147|NCT00896779|BG002|Baseline|Total|Total of all reporting groups
10968148|NCT00896779|FG000|Participant Flow|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
10968149|NCT00896779|FG001|Participant Flow|Ranibizumab Group 2|Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
10968150|NCT00896779|OG000|Outcome|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
10968151|NCT00896779|OG001|Outcome|Ranibizumab Group 2|Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
10968152|NCT00896779|EG000|Reported Event|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
10968153|NCT00896779|EG001|Reported Event|Ranibizumab Group 2|Group 2: 6 monthly injections of 0.5 mg then prn
10968154|NCT00897390|BG000|Baseline|All Enrolled and Treated Participants|
10968155|NCT00897390|FG000|Participant Flow|All Treated Participants|Participants were assigned to 1 of 4 treatment sequences (A-D-B-C, B-A-C-D, C-B-D-A, D-C-A-B). Treatment A=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fasted; Treatment B=fixed-dose combination (FDC) tablet of 2.5-mg saxagliptin/1000-mg metformin immediate release (IR), fasted; Treatment C=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fed; Treatment D=FDC tablet of 2.5-mg saxagliptin/1000-mg metformin IR, fed. The washout between each dose was at least 7 days.
10968156|NCT00897390|OG000|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
10968157|NCT00897390|OG001|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
10968158|NCT00897390|OG002|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
10968159|NCT00897390|OG003|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
10968160|NCT00897390|EG000|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions.
10968161|NCT00897390|EG001|Reported Event|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
10968162|NCT00897390|EG002|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal.
10968163|NCT00897390|EG003|Reported Event|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal.
10968164|NCT00897390|EG004|Reported Event|Not Dosed|58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
10968165|NCT00897676|BG000|Baseline|Subject Population|9 subjects were randomized to the vehicle first arm and the next day they were switched to exendin- (9-39). 7 subjects were randomized to the exendin-(9-39) first arm and the next day they were switched to vehicle. All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
10968166|NCT00897676|FG000|Participant Flow|Vehicle First Then Exendin-(9-39)|"An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. The following day, at time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, glucagon-like peptide-(GLP-1) , and glucagon will be measured every 30 minutes.~Vehicle: (0.9% NaCl)"
10968167|NCT00897676|FG001|Participant Flow|Exendin-(9-39) First Then Vehicle|"An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. The following day, at time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, glucagon-like peptide-(GLP-1) , and glucagon will be measured every 30 minutes.~Exendin-(9-39): 100-500pmol/kg/min"
10968168|NCT00897676|OG000|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to 360 min~Vehicle: (0.9% NaCl)"
10968169|NCT00897676|OG001|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to 360 min~Exendin-(9-39)"
10968170|NCT00897676|OG000|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 to time 360 min~Vehicle: (0.9% NaCl)"
10968171|NCT00897676|OG001|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously from time 0 to time 360 min at a dose of 100-500 pmol/kg/min~Exendin-(9-39)"
10968172|NCT00897676|OG000|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to time 360 min~Vehicle: (0.9% NaCl)"
10968173|NCT00897676|OG001|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min~Exendin-(9-39)"
10968174|NCT00897676|OG000|Outcome|Vehicle|"Subjects receive an infusion of vehicle( 0.9%NaCl) intravenously from time 0 to time 360 min~Vehicle: (0.9% NaCl)"
10968175|NCT00897676|OG001|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 to time 360 min~Exendin-(9-39)"
10968176|NCT00897676|OG000|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to time 360 min~Vehicle"
10968177|NCT00897676|EG000|Reported Event|Vehicle|"Subjects received an infusion of vehicle (0.9% NaCl) intravenously from time 0 min to time 360 min~Vehicle: (0.9% NaCl)"
10968178|NCT00897676|EG001|Reported Event|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min~Exendin-(9-39)"
10968179|NCT00897715|BG000|Baseline|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
10968180|NCT00897715|BG001|Baseline|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
10968181|NCT00897715|BG002|Baseline|Total|Total of all reporting groups
10968182|NCT00897715|FG000|Participant Flow|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
10968183|NCT00897715|FG001|Participant Flow|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
10968184|NCT00897715|OG000|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
10968185|NCT00897715|OG001|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
10968186|NCT00897715|EG000|Reported Event|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
10968187|NCT00897715|EG001|Reported Event|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
11206622|NCT02237092|OG001|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
10968188|NCT00897897|BG000|Baseline|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
10968189|NCT00897897|FG000|Participant Flow|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
10968190|NCT00897897|OG000|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
10968191|NCT00897897|EG000|Reported Event|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
10968192|NCT00898222|BG000|Baseline|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
10968193|NCT00898222|FG000|Participant Flow|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
10968194|NCT00898222|OG000|Outcome|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
10968195|NCT00898222|EG000|Reported Event|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
10968196|NCT00898443|BG000|Baseline|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
10968197|NCT00898443|BG001|Baseline|Epidural Anesthetic Group|This is the experimental group for this study.
10968198|NCT00898443|BG002|Baseline|Total|Total of all reporting groups
10968199|NCT00898443|FG000|Participant Flow|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
11206623|NCT02237092|OG000|Outcome|No Obesity|BMI < = 29.99
10968200|NCT00898443|FG001|Participant Flow|Epidural Anesthetic Group|This is the experimental group for this study.
10968201|NCT00898443|OG000|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
10968202|NCT00898443|OG001|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
10968203|NCT00898443|EG000|Reported Event|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
10968204|NCT00898443|EG001|Reported Event|Epidural Anesthetic Group|This is the experimental group for this study.
10968205|NCT00898560|BG000|Baseline|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
10968206|NCT00898560|FG000|Participant Flow|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
10968207|NCT00898560|OG000|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
10968208|NCT00898560|OG001|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
10968209|NCT00898560|EG000|Reported Event|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
10968210|NCT00898560|EG001|Reported Event|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
10968211|NCT00898807|BG000|Baseline|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
10968212|NCT00898807|BG001|Baseline|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
10968213|NCT00898807|BG002|Baseline|Total|Total of all reporting groups
10968214|NCT00898807|FG000|Participant Flow|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
10968215|NCT00898807|FG001|Participant Flow|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
10968216|NCT00898807|OG000|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
10968217|NCT00898807|OG001|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
10968218|NCT00898807|EG000|Reported Event|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
10968219|NCT00898807|EG001|Reported Event|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
10968220|NCT00898937|BG000|Baseline|Snap-frozen|Method of RNA recovery: Snap-frozen
10968221|NCT00898937|BG001|Baseline|RNALater|Method of RNA recovery: RNALater
10968222|NCT00898937|BG002|Baseline|Unknown|Method of RNA recovery: unknown
10968223|NCT00898937|BG003|Baseline|Total|Total of all reporting groups
10968224|NCT00898937|FG000|Participant Flow|Snap-frozen|"Method of RNA recovery: Snap-frozen~For more information about snap-frozen RNA recovery please see this link:~https://www.thermofisher.com/us/en/home/references/ambion-tech-support/rna-isolation/tech-notes/effect-of-freeze-thawing-of-tissue-on-rna-integrity.html"
10968225|NCT00898937|FG001|Participant Flow|RNALater|"Method of RNA recovery: RNALater~For more information on RNAlater please see this link: https://www.thermofisher.com/us/en/home/brands/product-brand/rnalater.html"
10968226|NCT00898937|FG002|Participant Flow||Method of RNA recovery: unknown
10968227|NCT00898937|OG000|Outcome|Snap-frozen|Method of RNA recovery: Snap-frozen
10968228|NCT00898937|OG001|Outcome|RNALater|Method of RNA recovery: RNALater
10968229|NCT00898937|OG002|Outcome|Unknown|Method of RNA recovery: unknown
10968230|NCT00898937|EG000|Reported Event|Snap-frozen|Method of RNA recovery: Snap-frozen
10968231|NCT00898937|EG001|Reported Event|RNALater|Method of RNA recovery: RNALater
10968232|NCT00898937|EG002|Reported Event||Method of RNA recovery: unknown
10968233|NCT00899353|BG000|Baseline|Omega 3 Supplementation|
10968234|NCT00899353|FG000|Participant Flow|Omega 3 Supplementation|Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
10968235|NCT00899353|OG000|Outcome|Baseline Nuclear Factor Kappa B Activation|Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
11206624|NCT02237092|OG001|Outcome|Obesity|BMI = > 30.00
11206625|NCT02237092|OG000|Outcome|Level of IAP < 16 mm Hg|number of pregnant women with Level of IAP < 16 mm Hg
10968236|NCT00899353|OG001|Outcome|Nuclear Factor Kappa B Activation Following 3 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
10968237|NCT00899353|OG002|Outcome|Nuclear Factor Kappa B Activation Following 6 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
10968238|NCT00899353|OG003|Outcome|Nuclear Factor Kappa B Activation Following 9 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
10968239|NCT00899353|OG004|Outcome|Nuclear Factor Kappa B Activation Post Supplement|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
10968240|NCT00899353|OG000|Outcome|Fold Change in ALC-Patient 1|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968241|NCT00899353|OG001|Outcome|Fold Change in ALC-Patient 2|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968242|NCT00899353|OG002|Outcome|Fold Change in ALC-Patient 3|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968243|NCT00899353|OG003|Outcome|Fold Change in ALC-Patient 4|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968244|NCT00899353|OG004|Outcome|Fold Change in ALC-Patient 5|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968245|NCT00899353|OG005|Outcome|Fold Change in ALC-Patient 6|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968246|NCT00899353|OG006|Outcome|Fold Change in ALC-Patient 7|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968247|NCT00899353|OG007|Outcome|Fold Change in ALC-Patient 8|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968248|NCT00899353|OG008|Outcome|Fold Change in ALC-Patient 9|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968249|NCT00899353|OG009|Outcome|Fold Change in ALC-Patient 10|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968250|NCT00899353|OG010|Outcome|Fold Change in ALC-Patient 11|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968251|NCT00899353|OG011|Outcome|Fold Change in ALC-Patient 13|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968252|NCT00899353|OG012|Outcome|Fold Change in ALC-Patient 14|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
10968253|NCT00899353|EG000|Reported Event|Adverse Effects|Serious adverse effects associated with omega 3 fatty acid consumption.
10968254|NCT00899392|BG000|Baseline|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
10968255|NCT00899392|BG001|Baseline|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
10968256|NCT00899392|BG002|Baseline|Total|Total of all reporting groups
10968257|NCT00899392|FG000|Participant Flow|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
10968258|NCT00899392|FG001|Participant Flow|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
10968259|NCT00899392|OG000|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
10968260|NCT00899392|OG001|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
10968261|NCT00899392|EG000|Reported Event|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
10968262|NCT00899392|EG001|Reported Event|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
10968263|NCT00899431|BG000|Baseline|Group 1|Not Randomized
10968264|NCT00899431|BG001|Baseline|Group 2|Randomized to Lenalidomide
10968265|NCT00899431|BG002|Baseline|Group 3|Randomized to not receive lenalidomide
10968266|NCT00899431|BG003|Baseline|Total|Total of all reporting groups
10968267|NCT00899431|FG000|Participant Flow|Not Randomized|Did not meet the necessary criteria after transplantation to be randomized for maintenance.
10968268|NCT00899431|FG001|Participant Flow|Randomized to Lenalidomide|1:1 randomization. This group receive the study drug Lenalidomide.
10968269|NCT00899431|FG002|Participant Flow|Randomized to Not Receive Lenalidomide|1:1 randomized. This group did not receive lenalidomide.
10968270|NCT00899431|OG000|Outcome|Not Randomized|Did not meet the necessary criteria after transplantation to be randomized for maintenance.
10968271|NCT00899431|OG001|Outcome|Randomized to Lenalidomide|1:1 randomization. This group receive the study drug Lenalidomide.
10968272|NCT00899431|OG002|Outcome|Randomized to Not Receive Lenalidomide|1:1 randomized. This group did not receive lenalidomide.
10968273|NCT00899431|OG000|Outcome|Group 1|Not Randomized
10968274|NCT00899431|OG001|Outcome|Group 2|Randomized to Lenalidomide
10968275|NCT00899431|OG002|Outcome|Group 3|Randomized to not receive lenalidomide
10968276|NCT00899431|EG000|Reported Event|Group 1|Not Randomized
10968277|NCT00899431|EG001|Reported Event|Group 2|Randomized to Lenalidomide
10968278|NCT00899431|EG002|Reported Event|Group 3|Randomized to not receive lenalidomide
10968279|NCT00899470|BG000|Baseline|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
10817903|NCT00014495|FG001|Participant Flow|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817904|NCT00014495|FG002|Participant Flow|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817905|NCT00014495|FG003|Participant Flow|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817906|NCT00014495|OG000|Outcome|Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.~Patients are followed twice weekly for 4 weeks and then monthly for 3 months~filgrastim~cytarabine~bismuth Bi213 monoclonal antibody M195"
10817907|NCT00014495|EG000|Reported Event|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817908|NCT00014495|EG001|Reported Event|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817909|NCT00014495|EG002|Reported Event|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817910|NCT00014495|EG003|Reported Event|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
10817911|NCT00014911|BG000|Baseline|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
11206626|NCT02237092|OG001|Outcome|Level of IAP = > 16 mm Hg|number of pregnant women with Level of IAP = > 16 mm Hg
10968280|NCT00899470|FG000|Participant Flow|S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)|Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
10968281|NCT00899470|FG001|Participant Flow|S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)|Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
10968282|NCT00899470|FG002|Participant Flow|S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)|Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
10968283|NCT00899470|FG003|Participant Flow|S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)|Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
10968284|NCT00899470|OG000|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
10968285|NCT00899470|OG001|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
10968286|NCT00899470|OG002|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
10968287|NCT00899470|OG003|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
10968288|NCT00899470|OG000|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
10968289|NCT00899470|OG001|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
10968290|NCT00899470|OG002|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
10968291|NCT00899470|OG003|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
10968292|NCT00899470|OG004|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
10968293|NCT00899470|EG000|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
10968294|NCT00899470|EG001|Reported Event|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
10968295|NCT00899470|EG002|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
10968296|NCT00899470|EG003|Reported Event|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
10968297|NCT00899548|BG000|Baseline|Metastatic Breast Cancer Patients|Adult women with metastatic breast cancer.
10968298|NCT00899548|FG000|Participant Flow|Metastatic Breast Cancer Patients|Adult women with metastatic breast cancer.
10968299|NCT00899548|OG000|Outcome|Metastatic Breast Cancer Patients -- CMI High|All subjects enrolled to the study with samples analyzed for the primary objective of DNA methylation in metastatic breast cancer patients who had a high CMI.
10968300|NCT00899548|OG001|Outcome|Metastatic Breast Cancer Patients -- CMI Low|All subjects enrolled to the study with samples analyzed for the primary objective of DNA methylation in metastatic breast cancer patients who had a low CMI.
10968301|NCT00899548|OG000|Outcome|Metastatic Breast Cancer Patients|"DNA methylation analysis, microarray analysis, polymerase chain reaction, laboratory biomarker analysis~DNA methylation analysis: laboratory analysis~microarray analysis: laboratory analysis~polymerase chain reaction: laboratory analysis~laboratory biomarker analysis: laboratory analysis"
10968302|NCT00899548|OG000|Outcome|Metastatic Breast Cancer Patients With Measured CMI and CTC|Subjects who had measured values of both CMI and CTC
10968303|NCT00899548|OG000|Outcome|Metastatic Breast Cancer Patients With Measured CTC Values|Subjects with metastatic breast cancer who had measured values of CTC
10968304|NCT00899548|EG000|Reported Event|Metastatic Breast Cancer Patients|Adult women with metastatic breast cancer.
10968305|NCT00899574|BG000|Baseline|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
10968306|NCT00899574|FG000|Participant Flow|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
11206627|NCT02237092|EG000|Reported Event|Level of Sensory Block => Th4 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
11206628|NCT02237092|EG001|Reported Event|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
10817912|NCT00014911|FG000|Participant Flow|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
10817913|NCT00014911|OG000|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
10817914|NCT00014911|EG000|Reported Event|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
10817915|NCT00015457|BG000|Baseline|Cervical Dystonia|All participants enrolled in study
10817916|NCT00015457|FG000|Participant Flow|Amlodipine Then Placebo|Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.
10817917|NCT00015457|FG001|Participant Flow|Placebo Then Amlodipine|Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
10817918|NCT00015457|OG000|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
11206629|NCT02237118|BG000|Baseline|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
11206630|NCT02237118|BG001|Baseline|UrgoTul|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
11206631|NCT02237118|BG002|Baseline|Total|Total of all reporting groups
11206632|NCT02237118|FG000|Participant Flow|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One"
11206633|NCT02237118|FG001|Participant Flow|UrgoTul|"Pain on removal by VAS~UrgoTul"
10817919|NCT00015457|OG001|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
10817920|NCT00015457|EG000|Reported Event|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
10817921|NCT00015457|EG001|Reported Event|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
10817922|NCT00015847|BG000|Baseline|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
10817923|NCT00015847|FG000|Participant Flow|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
10817924|NCT00015847|OG000|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
10817925|NCT00015847|EG000|Reported Event|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
10817926|NCT00016354|BG000|Baseline|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
10817927|NCT00016354|FG000|Participant Flow|Benzoylphenylurea 5 mg|Benzoylphenylurea dose level of 5 mg; Dose level 1
10817928|NCT00016354|FG001|Participant Flow|Benzoylphenylurea 10 mg|Benzoylphenylurea dose level of 10 mg; Dose level 2
11206634|NCT02237118|OG000|Outcome|Mepitel One|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
11206635|NCT02237118|OG001|Outcome|UrgoTul|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
11206636|NCT02237118|OG000|Outcome|Mepitel One|Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.
11206637|NCT02237118|OG001|Outcome|UrgoTul|Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.
11206638|NCT02237118|OG000|Outcome|Condition of the Wound Mepitel One|Condition of the wound assesed by the investigator
11206639|NCT02237118|OG001|Outcome|Condition of the Wound, UrgoTul|Condition of the wound, UrgoTul, assessed by the investigator
11206640|NCT02237118|OG000|Outcome|Safety Mepitel One|Adverse Event and Adverse Device Effect
11206641|NCT02237118|OG001|Outcome|Safety UrgoTul|Adverse Event and Adverse Device Effect
11206642|NCT02237118|OG000|Outcome|Mepitel One|Condition of the surrounding skin
11206643|NCT02237118|OG001|Outcome|UrgoTul|Condition of the surrounding skin
10817929|NCT00016354|FG002|Participant Flow|Benzoylphenylurea 20 mg|Benzoylphenylurea dose level of 20 mg; Dose level 3
10817930|NCT00016354|FG003|Participant Flow|Benzoylphenylurea 40 mg|Benzoylphenylurea dose level of 40 mg; Dose level 4
10817931|NCT00016354|FG004|Participant Flow|Benzoylphenylurea 80 mg|Benzoylphenylurea dose level of 80 mg; Dose level 5
10817932|NCT00016354|FG005|Participant Flow|Benzoylphenylurea 160 mg|Benzoylphenylurea dose level of 160 mg; Dose level 6
10817933|NCT00016354|FG006|Participant Flow|Benzoylphenylurea 320 mg|Benzoylphenylurea dose level of 320 mg; Dose level 7
10817934|NCT00016354|FG007|Participant Flow|Benzoylphenylurea Dose Level of 150 mg|Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
10817935|NCT00016354|OG000|Outcome|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
10817936|NCT00016354|EG000|Reported Event|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
10817937|NCT00016718|BG000|Baseline|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
10817938|NCT00016718|BG001|Baseline|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
10817939|NCT00016718|BG002|Baseline|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
10817940|NCT00016718|BG003|Baseline|Total|Total of all reporting groups
10817941|NCT00016718|FG000|Participant Flow|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
10817942|NCT00016718|FG001|Participant Flow|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
10817943|NCT00016718|FG002|Participant Flow|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
10817944|NCT00016718|OG000|Outcome|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
10817945|NCT00016718|OG001|Outcome|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
10817946|NCT00016718|OG002|Outcome|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
10817947|NCT00016718|EG000|Reported Event|Age Group 1|90 days to 3 years of age, inclusive (FTC, EFV, ddI)
10817948|NCT00016718|EG001|Reported Event|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
10817949|NCT00016718|EG002|Reported Event|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
10817950|NCT00016913|BG000|Baseline|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
10817951|NCT00016913|FG000|Participant Flow|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
10817952|NCT00016913|OG000|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
10817953|NCT00016913|EG000|Reported Event|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
10817954|NCT00017563|BG000|Baseline|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
10817955|NCT00017563|FG000|Participant Flow|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
10817956|NCT00017563|OG000|Outcome|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
10817957|NCT00017563|EG000|Reported Event|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
10817958|NCT00018031|BG000|Baseline|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
10817959|NCT00018031|FG000|Participant Flow|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
10817960|NCT00018031|OG000|Outcome|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
10817961|NCT00018031|EG000|Reported Event|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
10817962|NCT00019604|BG000|Baseline|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
10817963|NCT00019604|FG000|Participant Flow|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
11206644|NCT02237118|EG000|Reported Event|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
10817964|NCT00019604|OG000|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
10817965|NCT00019604|EG000|Reported Event|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
10817966|NCT00019682|BG000|Baseline|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817967|NCT00019682|BG001|Baseline|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817968|NCT00019682|BG002|Baseline|Total|Total of all reporting groups
10817969|NCT00019682|FG000|Participant Flow|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817970|NCT00019682|FG001|Participant Flow|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817971|NCT00019682|OG000|Outcome|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817972|NCT00019682|OG001|Outcome|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817973|NCT00019682|EG000|Reported Event|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817974|NCT00019682|EG001|Reported Event|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
10817975|NCT00021229|BG000|Baseline|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
11206645|NCT02237118|EG001|Reported Event|UrgoTul|"Pain on removal by VAS~Mepitel One~UrgoTul"
10968307|NCT00899574|OG000|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
10968308|NCT00899574|EG000|Reported Event|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
10968309|NCT00899600|BG000|Baseline|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
10968310|NCT00899600|BG001|Baseline|Ketamine|
11206646|NCT02237157|BG000|Baseline|Gemcitabine, Local Delivery|"Gemcitabine; 4 cycles, two doses per cycle; dose escalation~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
11206647|NCT02237157|FG000|Participant Flow|Gemcitabine, Local Delivery (Dose 1)|"Gemcitabine; 1 cycles, two doses per cycle; 250mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10968311|NCT00899600|BG002|Baseline|Total|Total of all reporting groups
10968312|NCT00899600|FG000|Participant Flow|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
10968313|NCT00899600|FG001|Participant Flow|Ketamine|
10968314|NCT00899600|OG000|Outcome|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
10968315|NCT00899600|OG001|Outcome|Ketamine|Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
10968316|NCT00899600|EG000|Reported Event|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
11206648|NCT02237157|FG001|Participant Flow|Gemcitabine, Local Delivery (Dose 2)|"Gemcitabine; 1 cycles, two doses per cycle; 500mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
11206649|NCT02237157|FG002|Participant Flow|Gemcitabine, Local Delivery (Dose 3)|"Gemcitabine; 1 cycles, two doses per cycle; 750mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10968317|NCT00899600|EG001|Reported Event|Ketamine|
10968318|NCT00899678|BG000|Baseline|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
10968319|NCT00899678|BG001|Baseline|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968320|NCT00899678|BG002|Baseline|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968321|NCT00899678|BG003|Baseline|Total|Total of all reporting groups
11206650|NCT02237157|FG003|Participant Flow|Gemcitabine, Local Delivery (Dose 4)|"Gemcitabine; 1 cycles, two doses per cycle; 1000mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
11206651|NCT02237157|OG000|Outcome|Gemcitabine, Local Delivery|"Gemcitabine; 4 cycles, two doses per cycle; dose escalation~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10968322|NCT00899678|FG000|Participant Flow|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
10968323|NCT00899678|FG001|Participant Flow|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968324|NCT00899678|FG002|Participant Flow|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968325|NCT00899678|OG000|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
11206652|NCT02237157|EG000|Reported Event|Gemcitabine, Local Delivery (Dose 1)|"Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
11206653|NCT02237157|EG001|Reported Event|Gemcitabine, Local Delivery (Dose 2)|"Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10817976|NCT00021229|BG001|Baseline|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
10817977|NCT00021229|BG002|Baseline|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
10817978|NCT00021229|BG003|Baseline|Total|Total of all reporting groups
10817979|NCT00021229|FG000|Participant Flow|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
10817980|NCT00021229|FG001|Participant Flow|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
10817981|NCT00021229|FG002|Participant Flow|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
10817982|NCT00021229|OG000|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
10817983|NCT00021229|OG000|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
10817984|NCT00021229|OG001|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
10817985|NCT00021229|OG001|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
11206654|NCT02237157|EG002|Reported Event|Gemcitabine, Local Delivery (Dose 3)|"Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10817986|NCT00021229|OG002|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
10817987|NCT00021229|EG000|Reported Event|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
10817988|NCT00021229|EG001|Reported Event|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
10817989|NCT00021229|EG002|Reported Event|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
10817990|NCT00021255|BG000|Baseline|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
10817991|NCT00021255|BG001|Baseline|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10817992|NCT00021255|BG002|Baseline|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10817993|NCT00021255|BG003|Baseline|Total|Total of all reporting groups
10817994|NCT00021255|FG000|Participant Flow|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
10817995|NCT00021255|FG001|Participant Flow|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10817996|NCT00021255|FG002|Participant Flow|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10817997|NCT00021255|OG000|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
10847819|NCT00286221|EG002|Reported Event|Infratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10817998|NCT00021255|OG001|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10817999|NCT00021255|OG002|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10818000|NCT00021255|EG000|Reported Event|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
10818001|NCT00021255|EG001|Reported Event|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10818002|NCT00021255|EG002|Reported Event|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
10818003|NCT00021541|BG000|Baseline|Phase A-Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. These are the patients that started on tipifarnib only. This number does not reflect the total amount of patients that crossed over to placebo.
10818004|NCT00021541|BG001|Baseline|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. These are the patients that started on placebo only. This number does not reflect the total amount of patients that crossed over to tipifarnib. Two of the 31 patients were deemed ineligible, thus 29 started placebo.
10818005|NCT00021541|BG002|Baseline|Total|Total of all reporting groups
10818006|NCT00021541|FG000|Participant Flow|Phase A -Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Patients receive tipifarnib ONLY in the first treatment until they progress to the second treatment/crossover to receive placebo.
10818007|NCT00021541|FG001|Participant Flow|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.Patients receive placebo ONLY in the first treatment until they progress to the second treatment/crossover to receive tipifarnib.
10818008|NCT00021541|OG000|Outcome|Phase A - Tipifarnib|Tipifarnib
10818009|NCT00021541|OG001|Outcome|Phase B - Placebo|Placebo
10818010|NCT00021541|OG000|Outcome|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
10818011|NCT00021541|OG000|Outcome|Phase A - Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10818012|NCT00021541|OG001|Outcome|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.
10818013|NCT00021541|EG000|Reported Event|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
10818014|NCT00022490|BG000|Baseline|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
10818015|NCT00022490|FG000|Participant Flow|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
10818016|NCT00022490|OG000|Outcome|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
10818017|NCT00022490|EG000|Reported Event|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
10818018|NCT00022516|BG000|Baseline|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
11206655|NCT02237157|EG003|Reported Event|Gemcitabine, Local Delivery (Dose 4)|"Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose~Gemcitabine, local delivery: Intra-arterial targeted drug delivery"
10968326|NCT00899678|OG001|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968327|NCT00899678|EG000|Reported Event|Induction Period|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
11286179|NCT02885025|BG003|Baseline|Placebo Pill + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
11286180|NCT02885025|BG004|Baseline|Total|Total of all reporting groups
10818019|NCT00022516|BG001|Baseline|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
10818020|NCT00022516|BG002|Baseline|Total|Total of all reporting groups
10818021|NCT00022516|FG000|Participant Flow|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
10818022|NCT00022516|FG001|Participant Flow|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
10818023|NCT00022516|OG000|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
10818024|NCT00022516|OG001|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
10818025|NCT00022516|EG000|Reported Event|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
10818026|NCT00022516|EG001|Reported Event|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
10818027|NCT00022633|BG000|Baseline|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818028|NCT00022633|BG001|Baseline|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818029|NCT00022633|BG002|Baseline|Total|Total of all reporting groups
10818030|NCT00022633|FG000|Participant Flow|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818031|NCT00022633|FG001|Participant Flow|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818032|NCT00022633|OG000|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818033|NCT00022633|OG000|Outcome|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818034|NCT00022633|EG000|Reported Event|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
10818035|NCT00022659|BG000|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818036|NCT00022659|FG000|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818037|NCT00022659|OG000|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818038|NCT00022659|OG000|Outcome|Grade 1 (CTCAE v 2.0)|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
10818039|NCT00022659|OG001|Outcome|Grade 2 (CTCAE v 2.0)|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
10818040|NCT00022659|OG002|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
10818041|NCT00022659|OG003|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
10818042|NCT00022659|EG000|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818043|NCT00022672|BG000|Baseline|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
10818044|NCT00022672|BG001|Baseline|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
10968328|NCT00899678|EG001|Reported Event|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968329|NCT00899678|EG002|Reported Event|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
10968330|NCT00899678|EG003|Reported Event|Overall Study|Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
10968331|NCT00899717|BG000|Baseline|Real Occlusal Adjustment|
10968332|NCT00899717|BG001|Baseline|Sham Occlusal Adjustment|
10968333|NCT00899717|BG002|Baseline|Total|Total of all reporting groups
10968334|NCT00899717|FG000|Participant Flow|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
10968335|NCT00899717|FG001|Participant Flow|Sham Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
10968336|NCT00899717|OG000|Outcome|Real Occlusal Adjustment|
10968337|NCT00899717|OG001|Outcome|Placebo Occlusal Adjustment|
10968338|NCT00899717|OG000|Outcome|Real|
10968339|NCT00899717|OG001|Outcome|Placebo|
10968340|NCT00899717|OG000|Outcome|Real Occlusal Adjustment|Number of patients who changed their habitual chewing side
10968341|NCT00899717|OG001|Outcome|Placebo Occlusal Adjustment|Number of patients who changed their habitual chewing side
10968342|NCT00899717|OG000|Outcome|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
10968343|NCT00899717|OG001|Outcome|Placebo Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
10968344|NCT00899717|EG000|Reported Event|Real Occlusal Adjustment|
10968345|NCT00899717|EG001|Reported Event|Sham Occlusal Adjustment|
10968346|NCT00899847|BG000|Baseline|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
10968347|NCT00899847|FG000|Participant Flow|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
10968348|NCT00899847|OG000|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
10968349|NCT00899847|OG000|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
10968350|NCT00899847|OG000|Outcome|Autologous-Allogeneic Peripheral Blood Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
10968351|NCT00899847|EG000|Reported Event|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
10968352|NCT00900029|BG000|Baseline|HP802-247 Vehicle|Acellular vehicle applied weekly
10968353|NCT00900029|BG001|Baseline|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
10968354|NCT00900029|BG002|Baseline|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
10818045|NCT00022672|BG002|Baseline|Total|Total of all reporting groups
10968355|NCT00900029|BG003|Baseline|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
10818046|NCT00022672|FG000|Participant Flow|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
10818047|NCT00022672|FG001|Participant Flow|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
10818048|NCT00022672|OG000|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
10818049|NCT00022672|OG001|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
10818050|NCT00022672|EG000|Reported Event|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
10818051|NCT00022672|EG001|Reported Event|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
10818052|NCT00022672|EG002|Reported Event|Anastrozole (After Start of Trastuzumab)|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
10818053|NCT00022698|BG000|Baseline|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818054|NCT00022698|BG001|Baseline|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818055|NCT00022698|BG002|Baseline|Total|Total of all reporting groups
10818056|NCT00022698|FG000|Participant Flow|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818057|NCT00022698|FG001|Participant Flow|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818058|NCT00022698|OG000|Outcome|Cohort 1, Initial Regimen:(Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818059|NCT00022698|OG001|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10847820|NCT00286221|EG003|Reported Event|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847821|NCT00286234|BG000|Baseline|Dual Placebo|"Dual placebo~placebo: omacor placebo plus niaspan placebo"
10847822|NCT00286234|BG001|Baseline|Niaspan|"niaspan~extended release niacin: 2 g qpm"
10847823|NCT00286234|BG002|Baseline|Lovaza|"lovaza~omega-3 acid ethyl esters: 4 q qd~omega-3 acid ethyl esters: 4 g qd"
11206656|NCT02237196|BG000|Baseline|AMG 157+Cat Immunotherapy|"AMG 157 will be administered every four weeks.~Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection"
11206657|NCT02237196|BG001|Baseline|AMG 157 Placebo+Cat Immunotherapy|"Placebo for AMG 157 of similar appearance will be administered every four weeks.~Cat immunotherapy will be administered weekly.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
10818060|NCT00022698|OG000|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818061|NCT00022698|OG002|Outcome|Total Participants (Cohort 1 + Cohort 2)|Total of all reporting groups.
10818062|NCT00022698|EG000|Reported Event|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818063|NCT00022698|EG001|Reported Event|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
10818064|NCT00022763|BG000|Baseline|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10818065|NCT00022763|BG001|Baseline|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10818066|NCT00022763|BG002|Baseline|Total|Total of all reporting groups
10818067|NCT00022763|FG000|Participant Flow|Stratum A|Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10818068|NCT00022763|FG001|Participant Flow|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10818069|NCT00022763|OG000|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10847824|NCT00286234|BG003|Baseline|Combined Therapy|"combined therapy~combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm"
10847825|NCT00286234|BG004|Baseline|Total|Total of all reporting groups
10847826|NCT00286234|FG000|Participant Flow|Dual Placebo|"Dual placebo~placebo: omacor placebo plus niaspan placebo"
11206658|NCT02237196|BG002|Baseline|AMG 157+Cat Immunotherapy Placebo|"AMG 157 will be administered every four weeks.~Placebo for Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously"
10818070|NCT00022763|OG001|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first.
10818071|NCT00022763|EG000|Reported Event|Enfuvirtide|Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
10818072|NCT00023309|BG000|Baseline|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
10818073|NCT00023309|BG001|Baseline|Adefovir|Patients to receive adefovir alone
10818074|NCT00023309|BG002|Baseline|Total|Total of all reporting groups
10818075|NCT00023309|FG000|Participant Flow|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
10818076|NCT00023309|FG001|Participant Flow|Adefovir|Patients to receive adefovir alone (10 mg daily).
10818077|NCT00023309|OG000|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
10818078|NCT00023309|OG001|Outcome|Adefovir|Patients to receive adefovir alone
10818079|NCT00023309|EG000|Reported Event|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
10818080|NCT00023309|EG001|Reported Event|Adefovir|Patients to receive adefovir alone
10818081|NCT00023322|BG000|Baseline|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
10818082|NCT00023322|FG000|Participant Flow|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
10818083|NCT00023322|OG000|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
10818084|NCT00023322|EG000|Reported Event|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
10818085|NCT00023452|BG000|Baseline|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10818086|NCT00023452|BG001|Baseline|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
10818087|NCT00023452|BG002|Baseline|Total|Total of all reporting groups
10818088|NCT00023452|FG000|Participant Flow|9INH|Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10818089|NCT00023452|FG001|Participant Flow|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.
10818090|NCT00023452|OG000|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) daily for 9 months (240 to 270 total doses).
10818091|NCT00023452|OG001|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
10818092|NCT00023452|OG000|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10818093|NCT00023452|OG000|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR], HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10847827|NCT00286234|FG001|Participant Flow|Niaspan|"niaspan~extended release niacin: 2 g qpm"
10847828|NCT00286234|FG002|Participant Flow|Lovaza|"lovaza~omega-3 acid ethyl esters: 4 q qd"
10818094|NCT00023452|OG001|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
10818095|NCT00023452|OG000|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10818096|NCT00023452|EG000|Reported Event|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
10818097|NCT00023452|EG001|Reported Event|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
10818098|NCT00023595|BG000|Baseline|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
10818099|NCT00023595|BG001|Baseline|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
10818100|NCT00023595|BG002|Baseline|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
10818101|NCT00023595|BG003|Baseline|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
10818102|NCT00023595|BG004|Baseline|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
10818103|NCT00023595|BG005|Baseline|Total|Total of all reporting groups
10818104|NCT00023595|FG000|Participant Flow|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
10818105|NCT00023595|FG001|Participant Flow|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
10818106|NCT00023595|FG002|Participant Flow|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
10818107|NCT00023595|FG003|Participant Flow|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
10818108|NCT00023595|FG004|Participant Flow|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
10818109|NCT00023595|OG000|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
10818110|NCT00023595|OG001|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
10818111|NCT00023595|OG000|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
10847829|NCT00286234|FG003|Participant Flow|Combined Therapy|"combined therapy~combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm"
10847830|NCT00286234|OG000|Outcome|Dual Placebo|"Dual placebo~placebo: omacor placebo plus niaspan placebo"
10847831|NCT00286234|OG001|Outcome|Niaspan|"niaspan~extended release niacin: 2 g qpm"
10847832|NCT00286234|OG002|Outcome|Lovaza|"lovaza~omega-3 acid ethyl esters: 4 q qd~omega-3 acid ethyl esters: 4 g qd"
10818112|NCT00023595|OG001|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
10818113|NCT00023595|OG000|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
10818114|NCT00023595|OG001|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
10818115|NCT00023595|OG000|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
10818116|NCT00023595|OG001|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
10818117|NCT00023595|OG000|Outcome|Total H02: Medication+CABG|
10818118|NCT00023595|OG001|Outcome|H02: Medication+CABG+SVR|
10818119|NCT00023595|OG000|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
10818120|NCT00023595|OG001|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
10818121|NCT00023595|OG000|Outcome|H01: Medication + CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease~CABG surgery plus MED (medication): CABG plus standard medication management for Coronary Artery Disease"
10818122|NCT00023595|OG001|Outcome|H01: Medication|"Medical therapy alone to treat Coronary Artery Disease~Active Medication Alone: Standard medication for coronary artery disease and heart failure management."
10818123|NCT00023595|OG000|Outcome|H02: Medication+CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease~CABG surgery plus MED: CABG plus standard medication management for Coronary Artery Disease"
10818124|NCT00023595|OG001|Outcome|H02: Medication+CABG+SVR|"CABG plus Medication and Surgical ventricular reconstruction (SVR)~CABG plus MED and SVR: H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone"
10818125|NCT00023595|EG000|Reported Event|H01: Medication|
10818126|NCT00023595|EG001|Reported Event|H01: Medication + CABG|
10818127|NCT00023595|EG002|Reported Event|H01 & H02: Medication+CABG|
10818128|NCT00023595|EG003|Reported Event|H02: Medication+CABG|
10818129|NCT00023595|EG004|Reported Event|H02: Medication+CABG+SVR|
10818130|NCT00023673|BG000|Baseline|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818131|NCT00023673|BG001|Baseline|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818132|NCT00023673|BG002|Baseline|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818133|NCT00023673|BG003|Baseline|Total|Total of all reporting groups
10818134|NCT00023673|FG000|Participant Flow|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818135|NCT00023673|FG001|Participant Flow|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818136|NCT00023673|FG002|Participant Flow|Phase I: 70 Gy/35 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10847833|NCT00286234|OG003|Outcome|Combined Therapy|"combined therapy~combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm"
10968356|NCT00900029|BG004|Baseline|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
10968357|NCT00900029|BG005|Baseline|Total|Total of all reporting groups
11206659|NCT02237196|BG003|Baseline|Placebo-Placebo|"Placebo for AMG 157 will be administered every four weeks.~Placebo for cat immunotherapy will be administered weekly.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
10818137|NCT00023673|FG003|Participant Flow|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818138|NCT00023673|OG000|Outcome|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818139|NCT00023673|OG001|Outcome|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818140|NCT00023673|OG000|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.~carboplatin~paclitaxel~three-dimensional conformal radiation therapy"
10818141|NCT00023673|OG000|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818142|NCT00023673|OG000|Outcome|No High Grade Toxicity|For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs.
10818143|NCT00023673|OG001|Outcome|High Grade Toxicity|For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs.
10818144|NCT00023673|EG000|Reported Event|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818145|NCT00023673|EG001|Reported Event|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
10818146|NCT00023712|BG000|Baseline|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818147|NCT00023712|BG001|Baseline|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818148|NCT00023712|BG002|Baseline|Total|Total of all reporting groups
10818149|NCT00023712|FG000|Participant Flow|Cohort 1 - Bortezomib (1.5 mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818150|NCT00023712|FG001|Participant Flow|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818151|NCT00023712|OG000|Outcome|Cohort 1 - Bortezomib 1.5 (mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10968358|NCT00900029|FG000|Participant Flow|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
11206660|NCT02237196|BG004|Baseline|Total|Total of all reporting groups
11206661|NCT02237196|FG000|Participant Flow|AMG 157+Cat Immunotherapy|"AMG 157 will be administered every four weeks.~Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection"
10968359|NCT00900029|FG001|Participant Flow|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
10968360|NCT00900029|FG002|Participant Flow|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
10968361|NCT00900029|FG003|Participant Flow|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
10968362|NCT00900029|FG004|Participant Flow|HP802-247 Vehicle|Acellular vehicle applied weekly applied to wound surface every week
10968363|NCT00900029|OG000|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
10968364|NCT00900029|OG001|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
10968365|NCT00900029|OG002|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
10968366|NCT00900029|OG003|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
10968367|NCT00900029|OG004|Outcome|HP802-247 Vehicle|Acellular vehicle applied weekly
10968368|NCT00900029|EG000|Reported Event|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
10968369|NCT00900029|EG001|Reported Event|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
10968370|NCT00900029|EG002|Reported Event|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
10968371|NCT00900029|EG003|Reported Event|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
10968372|NCT00900029|EG004|Reported Event|HP802-247 Vehicle|
10968373|NCT00900146|BG000|Baseline|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968374|NCT00900146|BG001|Baseline|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968375|NCT00900146|BG002|Baseline|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968376|NCT00900146|BG003|Baseline|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968377|NCT00900146|BG004|Baseline|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
10968378|NCT00900146|BG005|Baseline|Total|Total of all reporting groups
10968379|NCT00900146|FG000|Participant Flow|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968380|NCT00900146|FG001|Participant Flow|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10818152|NCT00023712|OG001|Outcome|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818153|NCT00023712|OG000|Outcome|Grade 0 AEs Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who did not experience the specified AE in cohort 1.
10818154|NCT00023712|OG001|Outcome|Grade 1 AEs (CTCAE v.2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 1
10818155|NCT00023712|OG002|Outcome|Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
10818156|NCT00023712|OG003|Outcome|Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
10818157|NCT00023712|OG004|Outcome|Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
10818158|NCT00023712|OG005|Outcome|Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who did not experience the specified AE in cohort 2
10818159|NCT00023712|OG006|Outcome|Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
10818160|NCT00023712|OG007|Outcome|Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
10818161|NCT00023712|OG008|Outcome|Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
10818162|NCT00023712|OG009|Outcome|Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
10818163|NCT00023712|EG000|Reported Event|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818164|NCT00023712|EG001|Reported Event|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
10818165|NCT00023764|BG000|Baseline|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
10818166|NCT00023764|FG000|Participant Flow|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
10818167|NCT00023764|OG000|Outcome|PS-341 (Bortezomib)-Relapsed Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
10818168|NCT00023764|OG001|Outcome|PS-341 (Bortezomib)-Refractory Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
10818169|NCT00023764|EG000|Reported Event|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
10818170|NCT00024102|BG000|Baseline|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
10818171|NCT00024102|BG001|Baseline|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
10818172|NCT00024102|BG002|Baseline|Total|Total of all reporting groups
10818173|NCT00024102|FG000|Participant Flow|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles~OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
10818174|NCT00024102|FG001|Participant Flow|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
10818175|NCT00024102|OG000|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
10818176|NCT00024102|OG001|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
10818177|NCT00024102|OG000|Outcome|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
10818178|NCT00024102|OG001|Outcome|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
10818179|NCT00024102|OG002|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
10818180|NCT00024102|EG000|Reported Event|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
10818181|NCT00024102|EG001|Reported Event|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
10818182|NCT00024102|EG002|Reported Event|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
10818183|NCT00024167|BG000|Baseline|Induction Treatment|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
10818184|NCT00024167|BG001|Baseline|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
10818185|NCT00024167|BG002|Baseline|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
10818186|NCT00024167|BG003|Baseline|Total|Total of all reporting groups
10818187|NCT00024167|FG000|Participant Flow|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
10818188|NCT00024167|FG001|Participant Flow|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
10818189|NCT00024167|OG000|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
10818190|NCT00024167|OG001|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
10818191|NCT00024167|EG000|Reported Event|Induction Treatment|Induction treatment option 1 or induction treatment option 2.
10818192|NCT00024167|EG001|Reported Event|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
10818193|NCT00024167|EG002|Reported Event|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
10818194|NCT00024258|BG000|Baseline|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
10818195|NCT00024258|FG000|Participant Flow|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
10818196|NCT00024258|OG000|Outcome|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
10818197|NCT00024258|EG000|Reported Event|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
10818198|NCT00025155|BG000|Baseline|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
10847834|NCT00286234|EG000|Reported Event|Dual Placebo|"Dual placebo~placebo: omacor placebo plus niaspan placebo"
10847835|NCT00286234|EG001|Reported Event|Niaspan|"niaspan~extended release niacin: 2 g qpm"
10847836|NCT00286234|EG002|Reported Event|Lovaza|"lovaza~omega-3 acid ethyl esters: 4 q qd~omega-3 acid ethyl esters: 4 g qd"
11206662|NCT02237196|FG001|Participant Flow|AMG 157 Placebo+Cat Immunotherapy|"Placebo for AMG 157 of similar appearance will be administered every four weeks.~Cat immunotherapy will be administered weekly.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
11206663|NCT02237196|FG002|Participant Flow|AMG 157+Cat Immunotherapy Placebo|"AMG 157 will be administered every four weeks.~Placebo for Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously"
11206664|NCT02237196|FG003|Participant Flow|Placebo-Placebo|"Placebo for AMG 157 will be administered every four weeks.~Placebo for cat immunotherapy will be administered weekly.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
11206665|NCT02237196|OG000|Outcome|AMG 157+Cat Immunotherapy|"AMG 157 will be administered every four weeks.~Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection"
10818199|NCT00025155|FG000|Participant Flow|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
10818200|NCT00025155|OG000|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
10818201|NCT00025155|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10818202|NCT00025155|OG001|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
10818203|NCT00025155|OG002|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
10818204|NCT00025155|OG003|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
10818205|NCT00025155|OG004|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
10818206|NCT00025155|EG000|Reported Event|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
10818207|NCT00025233|BG000|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818208|NCT00025233|FG000|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
11206666|NCT02237196|OG001|Outcome|AMG 157 Placebo+Cat Immunotherapy|"Placebo for AMG 157 of similar appearance will be administered every four weeks.~Cat immunotherapy will be administered weekly.~Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
11206667|NCT02237196|OG002|Outcome|AMG 157+Cat Immunotherapy Placebo|"AMG 157 will be administered every four weeks.~Placebo for Cat immunotherapy will be administered weekly.~AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously"
11206668|NCT02237196|OG003|Outcome|Placebo-Placebo|"Placebo for AMG 157 will be administered every four weeks.~Placebo for cat immunotherapy will be administered weekly.~Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously~AMG 157 Placebo: Placebo for AMG 157 administered intravenously"
10818209|NCT00025233|OG000|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10818210|NCT00025233|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10818211|NCT00025233|OG001|Outcome|Grade 1 (CTCAE v 2.0)|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
10818212|NCT00025233|OG002|Outcome|Grade 2 (CTCAE v 2.0)|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
10818213|NCT00025233|OG003|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
10818214|NCT00025233|OG004|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
10818215|NCT00025233|OG005|Outcome|Grade 5 (CTCAE v 2.0)|Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
10818216|NCT00025233|EG000|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
10847837|NCT00286234|EG003|Reported Event|Combined Therapy|"combined therapy~combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm"
10847838|NCT00286325|BG000|Baseline|Treated|Open label study subjects all treated with rituximab
10847839|NCT00286325|FG000|Participant Flow|Treated|Open label study subjects all treated with rituximab
10847840|NCT00286325|OG000|Outcome|Treated|Open label study subjects all treated with rituximab
10847841|NCT00286325|EG000|Reported Event|Treated|Open label study subjects all treated with rituximab
10847842|NCT00286429|BG000|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
10818217|NCT00025259|BG000|Baseline|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818218|NCT00025259|BG001|Baseline|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818219|NCT00025259|BG002|Baseline|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818220|NCT00025259|BG003|Baseline|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818221|NCT00025259|BG004|Baseline|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818222|NCT00025259|BG005|Baseline|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
10818223|NCT00025259|BG006|Baseline|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818224|NCT00025259|BG007|Baseline|Total|Total of all reporting groups
10818225|NCT00025259|FG000|Participant Flow|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10847843|NCT00286429|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847844|NCT00286429|BG002|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10818226|NCT00025259|FG001|Participant Flow|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818227|NCT00025259|FG002|Participant Flow|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818228|NCT00025259|FG003|Participant Flow|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818229|NCT00025259|FG004|Participant Flow|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818230|NCT00025259|FG005|Participant Flow|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
10818231|NCT00025259|FG006|Participant Flow|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818232|NCT00025259|OG000|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
10818233|NCT00025259|OG001|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
10818234|NCT00025259|OG002|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT (Reduced Therapy Arm)
10818235|NCT00025259|OG003|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
10818236|NCT00025259|OG004|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
10818237|NCT00025259|OG005|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
10818238|NCT00025259|OG006|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
10818239|NCT00025259|OG002|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
10818240|NCT00025259|OG004|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
10818241|NCT00025259|OG005|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
10847845|NCT00286429|BG003|Baseline|Total|Total of all reporting groups
10847846|NCT00286429|FG000|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
10847847|NCT00286429|FG001|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847848|NCT00286429|FG002|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
11206669|NCT02237196|EG000|Reported Event|AMG 157+Cat Immunotherapy|AMG 157 administered every four weeks and Cat immunotherapy administered weekly
10818242|NCT00025259|EG000|Reported Event|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818243|NCT00025259|EG001|Reported Event|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818244|NCT00025259|EG002|Reported Event|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818245|NCT00025259|EG003|Reported Event|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818246|NCT00025259|EG004|Reported Event|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818247|NCT00025259|EG005|Reported Event|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
10818248|NCT00025259|EG006|Reported Event|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
10818249|NCT00025506|BG000|Baseline|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
10818250|NCT00025506|FG000|Participant Flow|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
10818251|NCT00025506|OG000|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
10818252|NCT00025506|OG000|Outcome|Grade 0|Number of patients who did not experience the adverse event.
10818253|NCT00025506|OG001|Outcome|Grade 1|Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)
10818254|NCT00025506|OG002|Outcome|Grade 2|Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)
10818255|NCT00025506|OG003|Outcome|Grade 3|Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)
10818256|NCT00025506|OG004|Outcome|Grade 4|Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
10818257|NCT00025506|EG000|Reported Event|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
10818258|NCT00025662|BG000|Baseline|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
10818259|NCT00025662|FG000|Participant Flow|"RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants"|"Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults"
10818260|NCT00025662|OG000|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
10818261|NCT00025662|EG000|Reported Event|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
10818262|NCT00025883|BG000|Baseline|Metreleptin With Generalized Lipodystrophy|patients with generalized lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
10818263|NCT00025883|BG001|Baseline|Metreleptin With Patial Lipodystrophy|patients with partial lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
10818264|NCT00025883|BG002|Baseline|Total|Total of all reporting groups
10818265|NCT00025883|FG000|Participant Flow|Metreleptin|subcutaneous metreleptin injections in one to two daily doses ranging from 0.06 to 0.24 mg/kg/day.
10818266|NCT00025883|OG000|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
10818267|NCT00025883|OG001|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
10818268|NCT00025883|EG000|Reported Event|Metreleptin|subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
10818269|NCT00026208|BG000|Baseline|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
10818270|NCT00026208|BG001|Baseline|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
10818271|NCT00026208|BG002|Baseline|Total|Total of all reporting groups
10818272|NCT00026208|FG000|Participant Flow|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
10818273|NCT00026208|FG001|Participant Flow|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
10818274|NCT00026208|OG000|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
10847849|NCT00286429|OG000|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
10968381|NCT00900146|FG002|Participant Flow|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968382|NCT00900146|FG003|Participant Flow|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968383|NCT00900146|FG004|Participant Flow|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
10968384|NCT00900146|OG000|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968385|NCT00900146|OG001|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968386|NCT00900146|OG002|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968387|NCT00900146|OG003|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968388|NCT00900146|OG004|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
10968389|NCT00900146|EG000|Reported Event|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10970618|NCT00911300|BG001|Baseline|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
11206670|NCT02237196|EG001|Reported Event|AMG 157 Placebo+Cat Immunotherapy|Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly
10818275|NCT00026208|OG001|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
10818276|NCT00026208|EG000|Reported Event|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
10818277|NCT00026208|EG001|Reported Event|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
10818278|NCT00026221|BG000|Baseline|Arm I (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818279|NCT00026221|BG001|Baseline|Arm II (Monoclonal Antibody)|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
10818280|NCT00026221|BG002|Baseline|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818281|NCT00026221|BG003|Baseline|Total|Total of all reporting groups
10818282|NCT00026221|FG000|Participant Flow|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818283|NCT00026221|FG001|Participant Flow|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
10818284|NCT00026221|FG002|Participant Flow|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818285|NCT00026221|OG000|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818286|NCT00026221|OG001|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
10818287|NCT00026221|OG002|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818288|NCT00026221|EG000|Reported Event|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818289|NCT00026221|EG001|Reported Event|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
10818290|NCT00026221|EG002|Reported Event|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
10818291|NCT00026494|BG000|Baseline|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818292|NCT00026494|BG001|Baseline|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818293|NCT00026494|BG002|Baseline|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818294|NCT00026494|BG003|Baseline|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818295|NCT00026494|BG004|Baseline|Total|Total of all reporting groups
10818296|NCT00026494|FG000|Participant Flow|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818297|NCT00026494|FG001|Participant Flow|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818298|NCT00026494|FG002|Participant Flow|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818299|NCT00026494|FG003|Participant Flow|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818300|NCT00026494|OG000|Outcome|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818301|NCT00026494|OG001|Outcome|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818302|NCT00026494|OG002|Outcome|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818303|NCT00026494|OG003|Outcome|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818304|NCT00026494|EG000|Reported Event|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818305|NCT00026494|EG001|Reported Event|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818306|NCT00026494|EG002|Reported Event|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10970619|NCT00911300|BG002|Baseline|Total|Total of all reporting groups
10968390|NCT00900146|EG001|Reported Event|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968391|NCT00900146|EG002|Reported Event|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968392|NCT00900146|EG003|Reported Event|Canakinumab 150 mg + Metformin|"Experimental: Canakinumab 150 mg + Metformin In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
10968393|NCT00900146|EG004|Reported Event|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
10968394|NCT00900159|BG000|Baseline|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
10968395|NCT00900159|BG001|Baseline|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
10968396|NCT00900159|BG002|Baseline|Total|Total of all reporting groups
10968397|NCT00900159|FG000|Participant Flow|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
11244379|NCT02510664|OG002|Outcome|Provider|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10968398|NCT00900159|FG001|Participant Flow|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
10968399|NCT00900159|OG000|Outcome|Eszopiclone|Medication for insomnia symptoms
10968400|NCT00900159|OG001|Outcome|Placebo|Non-medicated pills
10968401|NCT00900159|EG000|Reported Event|Eszopiclone|eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
10968402|NCT00900159|EG001|Reported Event|Placebo|"eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)~placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)"
10968403|NCT00900237|BG000|Baseline|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
10968404|NCT00900237|BG001|Baseline|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
10968405|NCT00900237|BG002|Baseline|Total|Total of all reporting groups
10968406|NCT00900237|FG000|Participant Flow|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
10968407|NCT00900237|FG001|Participant Flow|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
10968408|NCT00900237|OG000|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
10968409|NCT00900237|OG001|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
10968410|NCT00900237|EG000|Reported Event|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
10818307|NCT00026494|EG003|Reported Event|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
10818308|NCT00026793|BG000|Baseline|Kaposi's Sarcoma|Adult patients with biopsy-proven cutaneous Kaposi's sarcoma
11206671|NCT02237196|EG002|Reported Event|AMG 157+Cat Immunotherapy Placebo|AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
11206672|NCT02237196|EG003|Reported Event|Placebo-Placebo|Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
11206673|NCT02237417|BG000|Baseline|Healthy Control|No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
10847850|NCT00286429|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847851|NCT00286429|OG002|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847852|NCT00286429|EG000|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
10847853|NCT00286429|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847854|NCT00286429|EG002|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
10847855|NCT00286442|BG000|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847856|NCT00286442|BG001|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847857|NCT00286442|BG002|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
10847858|NCT00286442|BG003|Baseline|Total|Total of all reporting groups
10847859|NCT00286442|FG000|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847860|NCT00286442|FG001|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847861|NCT00286442|FG002|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
10847862|NCT00286442|OG000|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847863|NCT00286442|OG001|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847864|NCT00286442|OG002|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
10847865|NCT00286442|EG000|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847866|NCT00286442|EG001|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
10847867|NCT00286442|EG002|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
10847868|NCT00286455|BG000|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10847869|NCT00286455|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
10847870|NCT00286455|BG002|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
10847871|NCT00286455|BG003|Baseline|Total|Total of all reporting groups
10847872|NCT00286455|FG000|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10847873|NCT00286455|FG001|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
10847874|NCT00286455|FG002|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
10847875|NCT00286455|OG000|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10847876|NCT00286455|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
10847877|NCT00286455|OG002|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
10847878|NCT00286455|EG000|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
10847879|NCT00286455|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
10847880|NCT00286455|EG002|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
10847881|NCT00286468|BG000|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
10847882|NCT00286468|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847883|NCT00286468|BG002|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847884|NCT00286468|BG003|Baseline|Total|Total of all reporting groups
10847885|NCT00286468|FG000|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
10847886|NCT00286468|FG001|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847887|NCT00286468|FG002|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847888|NCT00286468|OG000|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
10847889|NCT00286468|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847890|NCT00286468|OG002|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847891|NCT00286468|EG000|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
10847892|NCT00286468|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847893|NCT00286468|EG002|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
10847894|NCT00286494|BG000|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10818309|NCT00026793|FG000|Participant Flow|Kaposi's Sarcoma|Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
10818310|NCT00026793|OG000|Outcome|Kaposi's Sarcoma|Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
10818311|NCT00026793|EG000|Reported Event|Kaposi's Sarcoma|Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
10818312|NCT00027027|BG000|Baseline|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818313|NCT00027027|BG001|Baseline|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818314|NCT00027027|BG002|Baseline|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818315|NCT00027027|BG003|Baseline|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818316|NCT00027027|BG004|Baseline|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818317|NCT00027027|BG005|Baseline|Total|Total of all reporting groups
10818318|NCT00027027|FG000|Participant Flow|rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)|Recombinant Humanized Antibody to human epidermal growth factor receptor 2 (rhuMAb 2C4) 0.5 mg/kg was administered once every 3 weeks as an intravenous (IV) infusion until progressive disease (PD) or unacceptable toxicity occurred for up to a maximum of 1 year.
10818319|NCT00027027|FG001|Participant Flow|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818320|NCT00027027|FG002|Participant Flow|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818321|NCT00027027|FG003|Participant Flow|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818322|NCT00027027|FG004|Participant Flow|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818323|NCT00027027|OG000|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818324|NCT00027027|OG001|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818325|NCT00027027|OG002|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818326|NCT00027027|OG003|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818327|NCT00027027|OG004|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818328|NCT00027027|OG000|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818329|NCT00027027|OG001|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818330|NCT00027027|OG002|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818331|NCT00027027|OG003|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818332|NCT00027027|EG000|Reported Event|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818333|NCT00027027|EG001|Reported Event|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818334|NCT00027027|EG002|Reported Event|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818335|NCT00027027|EG003|Reported Event|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818336|NCT00027027|EG004|Reported Event|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
10818337|NCT00027378|BG000|Baseline|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818338|NCT00027378|BG001|Baseline|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818339|NCT00027378|BG002|Baseline|Total|Total of all reporting groups
10818340|NCT00027378|FG000|Participant Flow|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818341|NCT00027378|FG001|Participant Flow|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818342|NCT00027378|OG000|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818343|NCT00027378|OG001|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818344|NCT00027378|EG000|Reported Event|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818345|NCT00027378|EG001|Reported Event|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
10818346|NCT00027560|BG000|Baseline|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
10818347|NCT00027560|FG000|Participant Flow|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
10818348|NCT00027560|OG000|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
10818349|NCT00027560|OG000|Outcome|Matched Related Patients|
10818350|NCT00027560|OG000|Outcome|Unrelated and Mismatched Related Patients|
10818351|NCT00027560|EG000|Reported Event|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
10818352|NCT00027846|BG000|Baseline|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
11286181|NCT02885025|FG000|Participant Flow|BSE + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis."
10818353|NCT00027846|BG001|Baseline|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
10818354|NCT00027846|BG002|Baseline|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
10818355|NCT00027846|BG003|Baseline|Total|Total of all reporting groups
10818356|NCT00027846|FG000|Participant Flow|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
10818357|NCT00027846|FG001|Participant Flow|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
10818358|NCT00027846|FG002|Participant Flow|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
10818359|NCT00027846|OG000|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
10818360|NCT00027846|OG001|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
10847895|NCT00286494|BG001|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10847896|NCT00286494|BG002|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10847897|NCT00286494|BG003|Baseline|Total|Total of all reporting groups
10968411|NCT00900237|EG001|Reported Event|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
10968412|NCT00900562|BG000|Baseline|Endometrial Cancer|"Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968413|NCT00900562|BG001|Baseline|Cervical Cancer|"Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968414|NCT00900562|BG002|Baseline|Total|Total of all reporting groups
10968415|NCT00900562|FG000|Participant Flow|Endometrial Cancer|"Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968416|NCT00900562|FG001|Participant Flow|Cervical Cancer|"Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968417|NCT00900562|OG000|Outcome|Endometrial Cancer|"Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968418|NCT00900562|OG001|Outcome|Cervical Cancer|"Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968419|NCT00900562|OG000|Outcome|PM00104|Zalypsis (PM00104): Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
10968420|NCT00900562|EG000|Reported Event|Endometrial Cancer|"Patients with Endometrial Cancer. A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968421|NCT00900562|EG001|Reported Event|Cervical Cancer|"Patients with Cervical Cancer A treatment cycle consisted of the administration of i.v. 1-hour infusions of PM00104 on Day 1, Day 8 and Day 15, and all study evaluations done before the next cycle. Treatment cycles were to be repeated every four weeks.~Study treatment was administered to patients by a central catheter and by specialized on-site study personnel. A central catheter was mandatory as some cases of infusion site reactions were observed in the phase I trials"
10968422|NCT00900601|BG000|Baseline|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
10968423|NCT00900601|FG000|Participant Flow|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
10968424|NCT00900601|OG000|Outcome|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
10968425|NCT00900601|EG000|Reported Event|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
10968426|NCT00900627|BG000|Baseline|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968427|NCT00900627|BG001|Baseline|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968428|NCT00900627|BG002|Baseline|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968429|NCT00900627|BG003|Baseline|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968430|NCT00900627|BG004|Baseline|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968431|NCT00900627|BG005|Baseline|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968432|NCT00900627|BG006|Baseline|Total|Total of all reporting groups
10968433|NCT00900627|FG000|Participant Flow|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968434|NCT00900627|FG001|Participant Flow|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968435|NCT00900627|FG002|Participant Flow|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968436|NCT00900627|FG003|Participant Flow|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968437|NCT00900627|FG004|Participant Flow|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968438|NCT00900627|FG005|Participant Flow|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968439|NCT00900627|OG000|Outcome|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968440|NCT00900627|OG001|Outcome|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968441|NCT00900627|OG002|Outcome|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968442|NCT00900627|OG003|Outcome|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968443|NCT00900627|OG000|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968444|NCT00900627|OG001|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968445|NCT00900627|EG000|Reported Event|AZD8931 40 mg bd|
10968446|NCT00900627|EG001|Reported Event|AZD8931 80 mg bd|
10968447|NCT00900627|EG002|Reported Event|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968448|NCT00900627|EG003|Reported Event|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
10968449|NCT00900627|EG004|Reported Event|AZD8931 40MG bd + Paclitaxel|
10968450|NCT00900627|EG005|Reported Event|Placebo + Paclitaxel|
10968451|NCT00900666|BG000|Baseline|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
10968452|NCT00900666|BG001|Baseline|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
10968453|NCT00900666|BG002|Baseline|Total|Total of all reporting groups
10968454|NCT00900666|FG000|Participant Flow|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
10968455|NCT00900666|FG001|Participant Flow|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
10968456|NCT00900666|OG000|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
11286182|NCT02885025|FG001|Participant Flow|BSE + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
10968457|NCT00900666|OG001|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
10968458|NCT00900666|EG000|Reported Event|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
10968459|NCT00900666|EG001|Reported Event|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
10968460|NCT00900731|BG000|Baseline|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968461|NCT00900731|BG001|Baseline|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968462|NCT00900731|BG002|Baseline|Total|Total of all reporting groups
10968463|NCT00900731|FG000|Participant Flow|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968464|NCT00900731|FG001|Participant Flow|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968465|NCT00900731|OG000|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968466|NCT00900731|OG001|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968467|NCT00900731|EG000|Reported Event|Indacaterol 150 μg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968468|NCT00900731|EG001|Reported Event|Tiotropium 18 μg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
10968469|NCT00900757|BG000|Baseline|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
10968470|NCT00900757|FG000|Participant Flow|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
10968471|NCT00900757|OG000|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
10968472|NCT00900757|EG000|Reported Event|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
10968473|NCT00900796|BG000|Baseline|Anti-tumor Necrosis Factor Agents (Evaluable Population)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
10968474|NCT00900796|FG000|Participant Flow|Anti-tumor Necrosis Factor Agents|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
11206674|NCT02237417|BG001|Baseline|Individuals With Schizophrenia (Group A)|Standard of Care Oral antipsychotics: A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
10968475|NCT00900796|OG000|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
10968476|NCT00900796|OG000|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator's discretion.
10968477|NCT00900796|EG000|Reported Event|Anti-tumor Necrosis Factor Agents|Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
10968478|NCT00900822|BG000|Baseline|Straumann Bone Ceramic|Synthetic bone graft material
10968479|NCT00900822|FG000|Participant Flow|Straumann BoneCeramic|Synthetic bone graft material
10968480|NCT00900822|OG000|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
10968481|NCT00900822|OG001|Outcome|BioOss|Xenograft bone graft material
11206675|NCT02237417|BG002|Baseline|Individuals With Schizophrenia (Group B)|IM aripiprazole once monthly: A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
11206676|NCT02237417|BG003|Baseline|Total|Total of all reporting groups
11206677|NCT02237417|FG000|Participant Flow|Healthy Control|No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
10968482|NCT00900822|OG000|Outcome|Straumann BoneCeramic|Synthetic bone graft material
10968483|NCT00900822|EG000|Reported Event|Straumann Bone Ceramic|Synthetic bone graft material
11244380|NCT02510664|OG001|Outcome|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessment."
10818361|NCT00027846|OG002|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
10818362|NCT00027846|OG000|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
10818363|NCT00027846|OG000|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
10818364|NCT00027846|OG001|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
10818365|NCT00027846|EG000|Reported Event|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
10818366|NCT00027846|EG001|Reported Event|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
10818367|NCT00028002|BG000|Baseline|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
10818368|NCT00028002|FG000|Participant Flow|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
10818369|NCT00028002|OG000|Outcome|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
10818370|NCT00028002|OG000|Outcome|PET Patricipants|"FDG-PET was done at baseline, 1-7 days after IM initiation, in patients with GIST undergoing neoadjuvant IM therapy.~Tumor GLUT4 expression by immunohistochemistry (IHC) and mutation analyses were done at baseline and/or surgery. Background-subtracted SUVmax was measured in all lesions and summed; Metabolic Response (MR)based on EORTC criteria was compared to Response Evaluation Criteria in Solid Tumors (RECIST), GLUT4 expression, and KIT/PDGFRA mutation status."
10818371|NCT00028002|EG000|Reported Event|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
10818372|NCT00028093|BG000|Baseline|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
10818373|NCT00028093|BG001|Baseline|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
10818374|NCT00028093|BG002|Baseline|Total|Total of all reporting groups
10818375|NCT00028093|FG000|Participant Flow|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
10818376|NCT00028093|FG001|Participant Flow|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
10818377|NCT00028093|OG000|Outcome|Peginterferon+Ribavirin|
10818378|NCT00028093|OG001|Outcome|Peginterferon|
10818379|NCT00028093|EG000|Reported Event|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
10818380|NCT00028093|EG001|Reported Event|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
10818381|NCT00028262|BG000|Baseline|Drug Cystagon and N-acetylcysteine|
10818382|NCT00028262|FG000|Participant Flow|Drug Cystagon and N-acetylcysteine|
10818383|NCT00028262|OG000|Outcome|Drug Cystagon and N-acetylcysteine|
10818384|NCT00028262|EG000|Reported Event|Drug Cystagon and N-acetylcysteine|
10818385|NCT00028769|BG000|Baseline|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
10818386|NCT00028769|FG000|Participant Flow|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
10818387|NCT00028769|OG000|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
10847898|NCT00286494|FG000|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10968484|NCT00900822|EG001|Reported Event|BioOss|Xenograft bone graft material
11206678|NCT02237417|FG001|Participant Flow|Individuals With Schizophrenia (Group A)|Standard of Care Oral antipsychotics: A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
11206679|NCT02237417|FG002|Participant Flow|Individuals With Schizophrenia (Group B)|IM aripiprazole once monthly: A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
11206680|NCT02237417|OG000|Outcome|Healthy Control|No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
11206681|NCT02237417|OG001|Outcome|Individuals With Schizophrenia (Group A)|Standard of Care Oral antipsychotics: A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
11206682|NCT02237417|OG002|Outcome|Individuals With Schizophrenia (Group B)|IM aripiprazole once monthly: A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
11206683|NCT02237417|EG000|Reported Event|Healthy Control|No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
11206684|NCT02237417|EG001|Reported Event|Individuals With Schizophrenia (Group A)|Standard of Care Oral antipsychotics: A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
11206685|NCT02237417|EG002|Reported Event|Individuals With Schizophrenia (Group B)|IM aripiprazole once monthly: A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
11244381|NCT02510664|OG000|Outcome|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10968485|NCT00901017|BG000|Baseline|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
10968486|NCT00901017|FG000|Participant Flow|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
10968487|NCT00901017|OG000|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
10968488|NCT00901017|OG001|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
10968489|NCT00901017|OG001|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
10968490|NCT00901017|EG000|Reported Event|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
10968491|NCT00901017|EG001|Reported Event|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
10968492|NCT00901186|BG000|Baseline|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
10968493|NCT00901186|BG001|Baseline|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
10968494|NCT00901186|BG002|Baseline|Total|Total of all reporting groups
10968495|NCT00901186|FG000|Participant Flow|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
10968496|NCT00901186|FG001|Participant Flow|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
10968497|NCT00901186|OG000|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
10968498|NCT00901186|OG001|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
10968499|NCT00901186|EG000|Reported Event|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
10968500|NCT00901186|EG001|Reported Event|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
11286183|NCT02885025|FG002|Participant Flow|Placebo Pill + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE."
10968501|NCT00901199|BG000|Baseline|Deferasirox (Exjade) and Deferoxamine (DFO)|"Patients will receive combined chelation therapy using Deferasirox (Exjade) and Deferoxamine (DFO) with dosing based on liver iron concentration at baseline.~Patients with moderate iron overload,defined as liver iron concentration of 5-15mg/g plus a documented endocrinopathy or cardiac iron (low MRI T2*), will receive 7 days per week of Deferasirox (Exjade) 20-30 mg/kg and Deferoxamine (DFO) 50 mg/kg 3-5 days per week.~Patients with high iron overload, defined as liver iron concentration over 15mg/g will receive Deferasirox (Exjade) 20-30 mg/kg 7 days per week and Deferoxamine (DFO) 50 mg/kg 5-7 days per week."
10968502|NCT00901199|FG000|Participant Flow|Deferasirox (Exjade) and Deferoxamine (DFO)|"Patients will receive combined chelation therapy using Deferasirox (Exjade) and Deferoxamine (DFO) with dosing based on liver iron concentration at baseline.~Patients with moderate iron overload,defined as liver iron concentration of 5-15mg/g plus a documented endocrinopathy or cardiac iron (low MRI T2*), will receive 7 days per week of Deferasirox (Exjade) 20-30 mg/kg and Deferoxamine (DFO) 50 mg/kg 3-5 days per week.~Patients with high iron overload, defined as liver iron concentration over 15mg/g will receive Deferasirox (Exjade) 20-30 mg/kg 7 days per week and Deferoxamine (DFO) 50 mg/kg 5-7 days per week."
10968503|NCT00901199|OG000|Outcome|Deferasirox (Exjade) and Desferal (DFO)|Subjects were treated with Deferasirox (Exjade) and Desferal (DFO) with dosing based on baseline iron overload.
10968504|NCT00901199|EG000|Reported Event|Deferasirox (Exjade) and Deferoxamine (DFO)|Treatment with Deferasirox (Exjade) and Deferoxamine (DFO) with dosing based on baseline iron overload.
10968505|NCT00901225|BG000|Baseline|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
10968506|NCT00901225|FG000|Participant Flow|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
10968507|NCT00901225|OG000|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
10968508|NCT00901225|EG000|Reported Event|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
10968509|NCT00901316|BG000|Baseline|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
10818388|NCT00028769|EG000|Reported Event|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
10818389|NCT00029107|BG000|Baseline|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
10818390|NCT00029107|BG001|Baseline|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
10818391|NCT00029107|BG002|Baseline|Total|Total of all reporting groups
10818392|NCT00029107|FG000|Participant Flow|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
10818393|NCT00029107|FG001|Participant Flow|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
10818394|NCT00029107|OG000|Outcome|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
10818395|NCT00029107|OG001|Outcome|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
10818396|NCT00029107|EG000|Reported Event|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
10818397|NCT00029107|EG001|Reported Event|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
10818398|NCT00029146|BG000|Baseline|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
10818399|NCT00029146|BG001|Baseline|Non-surgical Group|Receives best current practice medical therapy
10818400|NCT00029146|BG002|Baseline|Total|Total of all reporting groups
10818401|NCT00029146|FG000|Participant Flow|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
10818402|NCT00029146|FG001|Participant Flow|Non-surgical Group|Receives best current practice medical therapy
10818403|NCT00029146|OG000|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
10818404|NCT00029146|OG001|Outcome|Non-surgical Group|Receives best current practice medical therapy
10818405|NCT00029146|EG000|Reported Event|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
10818406|NCT00029146|EG001|Reported Event|Non-surgical Group|Receives best current practice medical therapy
10818407|NCT00029172|BG000|Baseline|Case Management|
10818408|NCT00029172|FG000|Participant Flow|Case Management|
10818409|NCT00029172|OG000|Outcome|Case Management|
10818410|NCT00029172|EG000|Reported Event|Case Management|
10818411|NCT00029536|BG000|Baseline|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
10818412|NCT00029536|BG001|Baseline|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
10818413|NCT00029536|BG002|Baseline|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
10818414|NCT00029536|BG003|Baseline|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
10818415|NCT00029536|BG004|Baseline|Total|Total of all reporting groups
10818416|NCT00029536|FG000|Participant Flow|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
10818417|NCT00029536|FG001|Participant Flow|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
10818418|NCT00029536|FG002|Participant Flow|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
10818419|NCT00029536|FG003|Participant Flow|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
10818420|NCT00029536|OG000|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
10818421|NCT00029536|OG001|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
10818422|NCT00029536|OG002|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
10818423|NCT00029536|OG003|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
10818424|NCT00029536|OG000|Outcome|Progesterone Lozenges|Subjects with catamenial and Non-Catamential epilepsy who received 200 mg progesterone lozenges
10818425|NCT00029536|OG001|Outcome|Placebo Lozenges|Subjects with catamenial and non-Catamenial epilepsy who received matched placebo lozenges
10818426|NCT00029536|EG000|Reported Event|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
10818427|NCT00029536|EG001|Reported Event|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
10818428|NCT00029536|EG002|Reported Event|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
10818429|NCT00029536|EG003|Reported Event|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
10818430|NCT00030147|BG000|Baseline|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
10818431|NCT00030147|BG001|Baseline|Placebo|Placebo skin patch and placebo tablets for eight weeks
10818432|NCT00030147|BG002|Baseline|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
10818433|NCT00030147|BG003|Baseline|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
10818434|NCT00030147|BG004|Baseline|Total|Total of all reporting groups
10818435|NCT00030147|FG000|Participant Flow|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
10818436|NCT00030147|FG001|Participant Flow|Placebo|Placebo skin patch and placebo tablets for eight weeks
10818437|NCT00030147|FG002|Participant Flow|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
10818438|NCT00030147|FG003|Participant Flow|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
10818439|NCT00030147|OG000|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
10818440|NCT00030147|OG001|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
10818441|NCT00030147|OG002|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
10818442|NCT00030147|OG003|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
10818443|NCT00030147|EG000|Reported Event|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
10818444|NCT00030147|EG001|Reported Event|Placebo|Placebo skin patch and placebo tablets for eight weeks
10818445|NCT00030147|EG002|Reported Event|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
10818446|NCT00030147|EG003|Reported Event|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
10818447|NCT00030264|BG000|Baseline|Methotrexate & Vinblastine|"Methotrexate and Vinblastine will be given once a week for the first 26 weeks and then every two weeks for the next 26 weeks or until disease progression (whichever occurs first).~Methotrexate: Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)~Vinblastine: Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg."
10818448|NCT00030264|FG000|Participant Flow|Methotrexate & Vinblastine|"Methotrexate and Vinblastine will be given once a week for the first 26 weeks and then every two weeks for the next 26 weeks or until disease progression (whichever occurs first).~Methotrexate: Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)~Vinblastine: Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg."
10818449|NCT00030264|OG000|Outcome|Methotrexate & Vinblastine|"Methotrexate and Vinblastine will be given once a week for the first 26 weeks and then every two weeks for the next 26 weeks or until disease progression (whichever occurs first).~Methotrexate: Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)~Vinblastine: Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg."
10818450|NCT00030264|EG000|Reported Event|Methotrexate & Vinblastine|"Methotrexate and Vinblastine will be given once a week for the first 26 weeks and then every two weeks for the next 26 weeks or until disease progression (whichever occurs first).~Methotrexate: Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)~Vinblastine: Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg."
10818451|NCT00030823|BG000|Baseline|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
10818452|NCT00030823|FG000|Participant Flow|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
10818453|NCT00030823|OG000|Outcome|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
10818454|NCT00030823|EG000|Reported Event|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
10822060|NCT00074282|BG000|Baseline|Arm A (PCR)|"Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.~Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.~Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.~rituximab~cyclophosphamide~pentostatin"
10822061|NCT00074282|FG000|Participant Flow|Arm A (PCR)|"Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.~Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.~Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.~rituximab~cyclophosphamide~pentostatin"
10847899|NCT00286494|FG001|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10968510|NCT00901316|BG001|Baseline|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
10968511|NCT00901316|BG002|Baseline|Total|Total of all reporting groups
10968512|NCT00901316|FG000|Participant Flow|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
10968513|NCT00901316|FG001|Participant Flow|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
10968514|NCT00901316|OG000|Outcome|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
10968515|NCT00901316|OG001|Outcome|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
10968516|NCT00901316|EG000|Reported Event|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
10968517|NCT00901316|EG001|Reported Event|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
10968518|NCT00901342|BG000|Baseline|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
10968519|NCT00901342|FG000|Participant Flow|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
10968520|NCT00901342|OG000|Outcome|Sipuleucel-T|All subjects who received ≥ one sipuleucel-T infusion
10968521|NCT00901342|EG000|Reported Event|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
10968522|NCT00901394|BG000|Baseline|B-vitamins Plus Nitrous Oxide|
10968523|NCT00901394|BG001|Baseline|Nitrous Oxide Plus Placebo|
10968524|NCT00901394|BG002|Baseline|Nitrous Oxide-free Group Plus Placebo|
10818455|NCT00030901|BG000|Baseline|Selenium|Patients receive oral selenium once daily for 3 years
10968525|NCT00901394|BG003|Baseline|Total|Total of all reporting groups
10968526|NCT00901394|FG000|Participant Flow|B-vitamins Plus Nitrous Oxide|"IV vitamin B12 (cyanocobalamin) 1 mg,~IV folic acid, 5 mg,~60% nitrous oxide"
10968527|NCT00901394|FG001|Participant Flow|Nitrous Oxide Plus Placebo|"60% nitrous oxide~Placebo: normal saline (no vitamins)"
10968528|NCT00901394|FG002|Participant Flow|Nitrous Oxide-free Group Plus Placebo|"No nitrous oxide during anesthesia (oxygen/nitrogen)~Placebo: normal saline"
10968529|NCT00901394|OG000|Outcome|Treatment 1|"B12-Folic acid, nitrous oxide~B12-Folic Acid, nitrous oxide: IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.~IV folic acid, 5 mg, single administration over 30 min.~Both diluted in 250 ml normal saline.~Nitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline"
10968530|NCT00901394|OG001|Outcome|Treatment 2|"Nitrous oxide (NO) and placebo~Nitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline~Placebo: Saline"
10968531|NCT00901394|OG002|Outcome|Control Group|"oxygen nitrogen~Placebo: Saline~oxygen nitrogen: 60% air and oxygen mix."
10968532|NCT00901394|EG000|Reported Event|B-vitamins Plus Nitrous Oxide|
10968533|NCT00901394|EG001|Reported Event|Nitrous Oxide Plus Placebo|
10968534|NCT00901394|EG002|Reported Event|Nitrous Oxide-free Group Plus Placebo|
10968535|NCT00901459|BG000|Baseline|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
10968536|NCT00901459|FG000|Participant Flow|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
10968537|NCT00901459|OG000|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
10968538|NCT00901459|OG001|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
10968539|NCT00901459|OG002|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
10968540|NCT00901459|OG000|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
10968541|NCT00901459|OG001|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
10968542|NCT00901459|OG002|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
10968543|NCT00901459|EG000|Reported Event|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
10968544|NCT00901459|EG001|Reported Event|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
11244382|NCT02510664|OG000|Outcome|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments"
10968545|NCT00901459|EG002|Reported Event|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
10968546|NCT00901485|BG000|Baseline|All Patients|Patients underwent a cross over study design. In a randomised order they used 1 month of domiciliary nocturnal autotitrating, intelligent volume assured pressure support (iVAPS) non-invasive ventilation, and one month of standard non-invasive ventilation
10968547|NCT00901485|FG000|Participant Flow|AutoVPAP Then VPAPIIIST-A|"All patients underwent a cross over design -~1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation"
10968548|NCT00901485|FG001|Participant Flow|VPAPIIIST-A First, Then AutoVPAP|"All patients underwent a cross over design -~1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation"
10968549|NCT00901485|OG000|Outcome|Autotitrating iVAPS NIV|"AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.~All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy."
10968550|NCT00901485|OG001|Outcome|Standard Non-invasive PS Ventilation|"VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.~All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy."
10818456|NCT00030901|BG001|Baseline|Placebo|Patients receive oral placebo once daily for 3 years
10968551|NCT00901485|EG000|Reported Event|Autotitrating iVAPS NIV|"AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.~All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy."
10968552|NCT00901485|EG001|Reported Event|Standard Non-invasive PS Ventilation|"VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.~All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy."
10968553|NCT00901576|BG000|Baseline|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
10968554|NCT00901576|BG001|Baseline|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
10968555|NCT00901576|BG002|Baseline|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
10968556|NCT00901576|BG003|Baseline|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
10968557|NCT00901576|BG004|Baseline|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
10968558|NCT00901576|BG005|Baseline|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
10968559|NCT00901576|BG006|Baseline|Total|Total of all reporting groups
10968560|NCT00901576|FG000|Participant Flow|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
10968561|NCT00901576|FG001|Participant Flow|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
10818457|NCT00030901|BG002|Baseline|Total|Total of all reporting groups
10818458|NCT00030901|FG000|Participant Flow|All Patients|
10818459|NCT00030901|FG001|Participant Flow|Selenium|Patients receive oral selenium once daily for 3 years
10818460|NCT00030901|FG002|Participant Flow|Placebo|Patients receive oral placebo once daily for 3 years
10818461|NCT00030901|OG000|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
10818462|NCT00030901|OG001|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
10818463|NCT00030901|EG000|Reported Event|Selenium|Patients receive oral selenium once daily for 3 years
10818464|NCT00030901|EG001|Reported Event|Placebo|Patients receive oral placebo once daily for 3 years
10818465|NCT00030992|BG000|Baseline|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
10818466|NCT00030992|FG000|Participant Flow|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
10818467|NCT00030992|OG000|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
10818468|NCT00030992|EG000|Reported Event|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
10818469|NCT00031447|BG000|Baseline|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
10818470|NCT00031447|BG001|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818471|NCT00031447|BG002|Baseline|Total|Total of all reporting groups
10818472|NCT00031447|FG000|Participant Flow|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
10818473|NCT00031447|FG001|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818474|NCT00031447|OG000|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
10818475|NCT00031447|OG001|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818476|NCT00031447|EG000|Reported Event|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
10818477|NCT00031447|EG001|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818478|NCT00031460|BG000|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818479|NCT00031460|BG001|Baseline|Placebo|Identical volume as acyclovir.
10818480|NCT00031460|BG002|Baseline|Total|Total of all reporting groups
10818481|NCT00031460|FG000|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818482|NCT00031460|FG001|Participant Flow|Placebo|Identical volume as acyclovir.
10818483|NCT00031460|OG000|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818484|NCT00031460|OG001|Outcome|Placebo|Identical volume as acyclovir.
10818485|NCT00031460|EG000|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
10818486|NCT00031460|EG001|Reported Event|Placebo|Identical volume as acyclovir.
10818487|NCT00031486|BG000|Baseline|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
10818488|NCT00031486|BG001|Baseline|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
10818489|NCT00031486|BG002|Baseline|Total|Total of all reporting groups
10818490|NCT00031486|FG000|Participant Flow|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
10818491|NCT00031486|FG001|Participant Flow|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
10818492|NCT00031486|OG000|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
10818493|NCT00031486|OG001|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
10818494|NCT00031486|OG002|Outcome|Total|
10818495|NCT00031486|OG000|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
10818496|NCT00031486|EG000|Reported Event|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
10818497|NCT00031486|EG001|Reported Event|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
10818498|NCT00031551|BG000|Baseline|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
10818499|NCT00031551|BG001|Baseline|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
10818500|NCT00031551|BG002|Baseline|Total|Total of all reporting groups
10818501|NCT00031551|FG000|Participant Flow|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
10968562|NCT00901576|FG002|Participant Flow|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
10968563|NCT00901576|FG003|Participant Flow|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
10968564|NCT00901576|FG004|Participant Flow|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
10968565|NCT00901576|FG005|Participant Flow|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
10968566|NCT00901576|OG000|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
10968567|NCT00901576|OG001|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
10968568|NCT00901576|OG000|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
10968569|NCT00901576|EG000|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release guanfacine HCl
10968570|NCT00901576|EG001|Reported Event|Concerta Alone|Single 36 mg dose of extended-release methylphenidate HCl
10968571|NCT00901576|EG002|Reported Event|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
10968572|NCT00901628|BG000|Baseline|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
10968573|NCT00901628|BG001|Baseline|No Injection Group|usual postoperative care without periarticular injection
10968574|NCT00901628|BG002|Baseline|Total|Total of all reporting groups
10968575|NCT00901628|FG000|Participant Flow|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
10968576|NCT00901628|FG001|Participant Flow|No Injection Group|usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
10968577|NCT00901628|OG000|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
10968578|NCT00901628|OG001|Outcome|No Injection Group|usual postoperative care without periarticular injection
10968579|NCT00901628|EG000|Reported Event|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
10968580|NCT00901628|EG001|Reported Event|No Injection Group|usual postoperative care without periarticular injection
10968581|NCT00901901|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
10968582|NCT00901901|BG001|Baseline|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
10968583|NCT00901901|BG002|Baseline|Total|Total of all reporting groups
10968584|NCT00901901|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
10968585|NCT00901901|FG001|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
10968586|NCT00901901|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
10968587|NCT00901901|OG001|Outcome|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
10968588|NCT00901901|OG000|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
10968589|NCT00901901|OG001|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
10968590|NCT00901901|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd).
10968591|NCT00901901|EG001|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd).
10968592|NCT00901927|BG000|Baseline|Bendamustine + Mitoxantrone + Rituximab|Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
10968593|NCT00901927|FG000|Participant Flow|Bendamustine + Mitoxantrone + Rituximab|Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
10968594|NCT00901927|OG000|Outcome|Bendamustine + Mitoxantrone + Rituximab|Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
10968595|NCT00901927|EG000|Reported Event|Bendamustine + Mitoxantrone + Rituximab|Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
10968596|NCT00902018|BG000|Baseline|Eltrombopag Arm|Participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.
10968597|NCT00902018|BG001|Baseline|Eltrombopag Receiving Romiplostim|Three Participants who had been on eltrombopag in the past will undergo a washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks.
10968598|NCT00902018|BG002|Baseline|Healthy Volunteers|single blood draw in healthy volunteers (controls)
10968599|NCT00902018|BG003|Baseline|Total|Total of all reporting groups
10968600|NCT00902018|FG000|Participant Flow|Eltrombopag|"Promacta (eltrombopag): Subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times a week for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.~first blood draw before taking eltrombopag"
10968601|NCT00902018|FG001|Participant Flow|Eltombopag Then Romiplostim|patients who receive eltrombopag and then are treated with romiplostim (nplate) to ascertain parallelism between the two agents
10968602|NCT00902018|FG002|Participant Flow|Healthy Volunteer|one blood draw only
10968603|NCT00902018|OG000|Outcome|Eltrombopag Arm|Participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.
10968604|NCT00902018|OG001|Outcome|Eltrombopag Then Romiplostim|Three Participants from Eltrombopag arm will undergo second washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks exactly like when they received Eltrombopag.
10968605|NCT00902018|OG002|Outcome|Healthy Controls|10 normal volunteers for a single blood draw
10968606|NCT00902018|OG000|Outcome|Romiplostim Treated Patients|3 patients treated with romiplostim 10 micrograms/kg weekly twice with weekly platelet counts on days 1, 8, and 15
10968607|NCT00902018|OG000|Outcome|Eltrombopag|"10 ITP patients were treated with daily oral eltrombopag 75mg for 2 weeks and testing was done at weekly intervals 3 times they then were allowed to receive long-term eltrombopag~Eltrombopag: The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times a week for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months."
10968608|NCT00902018|OG001|Outcome|Romiplostim|"3 patients, who first received eltrombopag, were treated with romiplostim 10 micrograms/kg weekly for 2 weeks with the same testing done at weekly intervals three times~Romiplostim: three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times and blood counts monitored 3 times per week"
10968609|NCT00902018|OG002|Outcome|Healthy Controls|healthy controls: single blood draw for all measures included in the intervention arms
10968610|NCT00902018|OG001|Outcome|Eltrombopag Then Romiplostim|"Three Participants were treated identically as per the eltrombopag arm and, several months later, would undergo a second washout period and were treated with Romiplostim 10 ug/kg/weekly for 2 weeks.~Participants on Romiplostim will be monitored as were the Eltrombopag participants for 2 weeks."
11206686|NCT02237898|BG000|Baseline|MoMba Contingency Management|"MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.~The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).~The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.~Most breath tests will be completed remotely."
10968611|NCT00902018|OG002|Outcome|Healthy Control Group|10 Control Participants without thrombocytopenia or any major health issues were enrolled to provide laboratory comparison data to the ITP patients with a single blood draw for platelet counts, IPF, large platelets, IC50 for apoptosis, AKT pathway intermediates.
10968612|NCT00902018|EG000|Reported Event|Eltrombopag|Ten participants will be treated with eltrombopag 75 mg once daily. Participants will be monitored three times a week for the first two weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for four months.
10968613|NCT00902018|EG001|Reported Event|Romiplostim|Three Participants who had been on eltrombopag will undergo a washout period and will be treated with Romiplostim 10 ug/kg/weekly for 2 weeks. Participants on Romiplostim will be monitored three times a week for two weeks.
10968614|NCT00902018|EG002|Reported Event|Healthy Volunteers|single blood draw in healthy controls/volunteers
10968615|NCT00902161|BG000|Baseline|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968616|NCT00902161|BG001|Baseline|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968617|NCT00902161|BG002|Baseline|Total|Total of all reporting groups
10968618|NCT00902161|FG000|Participant Flow|Propanolol + MK0893 / Propanolol + Placebo|After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
10968619|NCT00902161|FG001|Participant Flow|Propanolol + Placebo / Propanolol + MK0893|After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
10968620|NCT00902161|FG002|Participant Flow|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).
10968621|NCT00902161|OG000|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968622|NCT00902161|OG001|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968623|NCT00902161|OG000|Outcome|MK0893|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968624|NCT00902161|OG001|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968625|NCT00902161|OG002|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
10968626|NCT00902161|EG000|Reported Event|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968627|NCT00902161|EG001|Reported Event|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
10968628|NCT00902161|EG002|Reported Event|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
10968629|NCT00902174|BG000|Baseline|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
10968630|NCT00902174|BG001|Baseline|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
10968631|NCT00902174|BG002|Baseline|Total|Total of all reporting groups
10968632|NCT00902174|FG000|Participant Flow|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
10968633|NCT00902174|FG001|Participant Flow|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
10968634|NCT00902174|OG000|Outcome|Imatinib|imatinib mesylate
10968635|NCT00902174|OG001|Outcome|Placebo|Placebo to imatinib
10968636|NCT00902174|OG000|Outcome|Imatinib 200 mg|imatinib mesylate 200 mg once daily
10968637|NCT00902174|OG001|Outcome|GCP74588|imatinib metabolite
10968638|NCT00902174|OG000|Outcome|Imatinib 400 mg|imatinib mesylate 400 mg once daily
10968639|NCT00902174|EG000|Reported Event|Imatinib|imatinib mesylate
10968640|NCT00902174|EG001|Reported Event|Placebo|Placebo to imatinib
10968641|NCT00902226|BG000|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968642|NCT00902226|FG000|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968643|NCT00902226|OG000|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968644|NCT00902226|EG000|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968645|NCT00902265|BG000|Baseline|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
10968646|NCT00902265|FG000|Participant Flow|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
10968647|NCT00902265|OG000|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
10968648|NCT00902265|EG000|Reported Event|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
10968649|NCT00902278|BG000|Baseline|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
10968650|NCT00902278|BG001|Baseline|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
10968651|NCT00902278|BG002|Baseline|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
10968652|NCT00902278|BG003|Baseline|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
10968653|NCT00902278|BG004|Baseline|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
10968654|NCT00902278|BG005|Baseline|Total|Total of all reporting groups
10968655|NCT00902278|FG000|Participant Flow|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
10968656|NCT00902278|FG001|Participant Flow|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
10968657|NCT00902278|FG002|Participant Flow|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
10968658|NCT00902278|FG003|Participant Flow|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
10968659|NCT00902278|FG004|Participant Flow|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
10968660|NCT00902278|OG000|Outcome|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
10968661|NCT00902278|OG001|Outcome|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
10968662|NCT00902278|OG002|Outcome|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
10968663|NCT00902278|OG003|Outcome|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
10968664|NCT00902278|OG004|Outcome|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
10968665|NCT00902278|EG000|Reported Event|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
10968666|NCT00902278|EG001|Reported Event|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
10968667|NCT00902278|EG002|Reported Event|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
10968668|NCT00902278|EG003|Reported Event|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
10968669|NCT00902278|EG004|Reported Event|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
10968670|NCT00902304|BG000|Baseline|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
10968671|NCT00902304|BG001|Baseline|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968672|NCT00902304|BG002|Baseline|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968673|NCT00902304|BG003|Baseline|Total|Total of all reporting groups
10968674|NCT00902304|FG000|Participant Flow|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
10968675|NCT00902304|FG001|Participant Flow|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968676|NCT00902304|FG002|Participant Flow|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968677|NCT00902304|OG000|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
10968678|NCT00902304|OG001|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968679|NCT00902304|OG002|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968680|NCT00902304|EG000|Reported Event|Pre-randomization|Pre-randomization
10968681|NCT00902304|EG001|Reported Event|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
10968682|NCT00902304|EG002|Reported Event|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968683|NCT00902304|EG003|Reported Event|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
10968684|NCT00902330|BG000|Baseline|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
10968685|NCT00902330|BG001|Baseline|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
10968686|NCT00902330|BG002|Baseline|Total|Total of all reporting groups
10968687|NCT00902330|FG000|Participant Flow|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
10968688|NCT00902330|FG001|Participant Flow|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
10968689|NCT00902330|OG000|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
10968690|NCT00902330|OG001|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
10968691|NCT00902330|OG000|Outcome|All Patients Analyzed|All patients
10968692|NCT00902330|OG000|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
10968693|NCT00902330|OG001|Outcome|Arm II|Sham CES
10968694|NCT00902330|EG000|Reported Event|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
10968695|NCT00902330|EG001|Reported Event|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
10968696|NCT00902486|BG000|Baseline|INCB028050 4 mg QD|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968697|NCT00902486|BG001|Baseline|INCB028050 7 mg QD|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968698|NCT00902486|BG002|Baseline|INCB028050 10 mg QD|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968699|NCT00902486|BG003|Baseline|Placebo|INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968700|NCT00902486|BG004|Baseline|Total|Total of all reporting groups
10968701|NCT00902486|FG000|Participant Flow|Placebo|INCB028050 was administered once daily (QD), orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968702|NCT00902486|FG001|Participant Flow|Placebo Crossing Over to 7 mg INCB028050 QD|Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.
10968703|NCT00902486|FG002|Participant Flow|Placebo Crossing Over to 10 mg INCB028050 QD|Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.
10968704|NCT00902486|FG003|Participant Flow|INCB028050 4 mg QD|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968705|NCT00902486|FG004|Participant Flow|INCB028050 7 mg QD|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968706|NCT00902486|FG005|Participant Flow|INCB028050 10 mg QD|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
11206687|NCT02237898|BG001|Baseline|Office Contingency Management|"The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.~Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.~Control participants will not have access to the MoMba Live Long app."
10968707|NCT00902486|OG000|Outcome|Placebo|INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968708|NCT00902486|OG001|Outcome|INCB028050 4 mg QD|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968709|NCT00902486|OG002|Outcome|INCB028050 7 mg QD|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968710|NCT00902486|OG003|Outcome|INCB028050 10 mg QD|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968711|NCT00902486|OG000|Outcome|Placebo Crossing Over to 7 mg INCB028050 QD|Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.
10968712|NCT00902486|OG001|Outcome|Placebo Crossing Over to 10 mg INCB028050 QD|Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.
10968713|NCT00902486|OG002|Outcome|INCB028050 4 mg QD|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968714|NCT00902486|OG003|Outcome|INCB028050 7 mg QD|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968715|NCT00902486|OG004|Outcome|INCB028050 10 mg QD|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968716|NCT00902486|OG000|Outcome|INCB028050 4 mg QD|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968717|NCT00902486|OG001|Outcome|INCB028050 7 mg QD|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968718|NCT00902486|OG002|Outcome|INCB028050 10 mg QD|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10818502|NCT00031551|FG001|Participant Flow|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
10818503|NCT00031551|OG000|Outcome|Main Study: Etanercept Mouthwash|"Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Etanercept"
10818504|NCT00031551|OG001|Outcome|Main Study: Placebo Mouthwash|"Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.~Placebo"
10818505|NCT00031551|OG000|Outcome|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
10818506|NCT00031551|OG000|Outcome|Pilot Study: Baseline Scores|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
10818507|NCT00031551|OG001|Outcome|Pilot Study: Day 9 After CT Scores|
10818508|NCT00031551|OG000|Outcome|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
10818509|NCT00031551|EG000|Reported Event|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
10818510|NCT00031551|EG001|Reported Event|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
10818511|NCT00031590|BG000|Baseline|Study Treatment|"All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with vincristine. 4 weeks after radiation and vincristine treatment is completed, all subjects will begin 9 cycles (each cycle lasts 6 weeks) of maintenance chemotherapy which will be given as 2 different drug combinations, Regimen A (Lomustine, Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide) which will be given in the following order (total of 54 weeks):1st-Regimen A, 2nd-Regimen A, 3rd-Regimen B, 4th-Regimen A, 5th-Regimen A, 6th-Regimen B, 7th-Regimen A, 8th-Regimen A, 9th-Regimen B. Cisplatin: Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only). Cyclophosphamide: Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6"
10818512|NCT00031590|FG000|Participant Flow|Study Treatment|"All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with vincristine. 4 weeks after radiation and vincristine treatment is completed, all subjects will begin 9 cycles (each cycle lasts 6 weeks) of maintenance chemotherapy which will be given as 2 different drug combinations, Regimen A (Lomustine, Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide) which will be given in the following order (total of 54 weeks):1st-Regimen A, 2nd-Regimen A, 3rd-Regimen B, 4th-Regimen A, 5th-Regimen A, 6th-Regimen B, 7th-Regimen A, 8th-Regimen A, 9th-Regimen B. Cisplatin: Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only). Cyclophosphamide: Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6"
10818513|NCT00031590|OG000|Outcome|Study Treatment|"All subjects will undergo surgical resection and routine staging (MRI spine and LP for CSF cytology). Subjects aged 3-30 yrs with M0 disease are eligible. Treatment must begin within 28 days of surgery. Reduced dose craniospinal irradiation (CSI) (1800 centiGray (cGy) CSI + 3780 cGy tumor bed) will last for 6 weeks with concurrent, weekly vincristine. 4 weeks after radiation therapy is completed, all subjects will begin 9 cycles of maintenance chemotherapy: Regimen A (CCNU, Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide). Cycles will be given as AABAABAAB~Regimen A:~Cisplatin: 70mg/m2/dose x 1 dose on day 0 Vincristine: 1.5 mg/m2/dose on days 0, 7, 14 CCNU: 75 mg/m2/dose x 1 dose on day 0~Regimen B:~Cyclophosphamide: 1g/m2/dose on days 0 and 1 Etoposide: 150 mg/m2/dose (IV) on days 0 and 1 Etoposide: 50 mg/m2/day PO on days 14-34 (21 days total)"
10818514|NCT00031590|OG000|Outcome|Study Treatment|"All subjects will undergo surgical resection and routine staging (Magnetic Resonance Imagine (MRI) spine and Lumbar Puncture (LP) for cerebrospinal fluid (CSF) cytology). Subjects aged 3-30 yrs with M0 disease are eligible. Treatment must begin within 28 days of surgery. Reduced dose craniospinal RT (1800 cGy CSI + 3780 cGy tumor bed) will last for 6 weeks with concurrent, weekly vincristine. 4 weeks after radiation therapy is completed, all subjects will begin 9 cycles of maintenance chemotherapy: Regimen A (Lomustine (CCNU), Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide). Cycles will be given as AABAABAAB~Regimen A:~Cisplatin: 70mg/m2/dose x 1 dose on day 0 Vincristine: 1.5 mg/m2/dose on days 0, 7, 14 CCNU: 75 mg/m2/dose x 1 dose on day 0~Regimen B:~Cyclophosphamide: 1g/m2/dose on days 0 and 1 Etoposide: 150 mg/m2/dose intravenous (IV) on days 0 and 1 Etoposide: 50 mg/m2/day oral (PO) on days 14-34 (21 days total)"
10847900|NCT00286494|FG002|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10968719|NCT00902486|OG000|Outcome|Placebo to INCB028050 7 mg QD|Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
10968720|NCT00902486|OG001|Outcome|Placebo to INCB028050 10 mg QD|Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
10968721|NCT00902486|EG000|Reported Event|Placebo (Weeks 0-12)|INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968722|NCT00902486|EG001|Reported Event|INCB028050 4 mg QD (Weeks 0-12)|INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968723|NCT00902486|EG002|Reported Event|INCB028050 7 mg QD (Weeks 0-12)|INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968724|NCT00902486|EG003|Reported Event|INCB028050 10 mg QD (Weeks 0-12)|INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
10968725|NCT00902486|EG004|Reported Event|Placebo to INCB028050 7 mg QD|12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
10968726|NCT00902486|EG005|Reported Event|Placebo to INCB028050 10 mg QD|12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
10968727|NCT00902486|EG006|Reported Event|INCB028050 4 mg QD (Weeks 12-24)|12-week extension period
10968728|NCT00902486|EG007|Reported Event|INCB028050 7 mg QD (Weeks 12-24)|12-week extension period
10968729|NCT00902486|EG008|Reported Event|INCB028050 10 mg QD (Weeks 12-24)|12-week extension period
10968730|NCT00902486|EG009|Reported Event|Placebo to INCB028050 7 mg QD (After Week 24 to Week 28)|Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
10968731|NCT00902486|EG010|Reported Event|Placebo to INCB028050 10 mg QD (After Week 24 to Week 28)|Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
10968732|NCT00902486|EG011|Reported Event|INCB028050 4 mg QD (After Week 24 to Week 28)|Follow-up
10968733|NCT00902486|EG012|Reported Event|INCB028050 7 mg QD (After Week 24 to Week 28)|Follow-up
10968734|NCT00902486|EG013|Reported Event|INCB028050 10 mg QD (After Week 24 to Week 28)|Follow-up
10968735|NCT00902538|BG000|Baseline|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
10968736|NCT00902538|BG001|Baseline|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
10968737|NCT00902538|BG002|Baseline|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
10968738|NCT00902538|BG003|Baseline|Total|Total of all reporting groups
10968739|NCT00902538|FG000|Participant Flow|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
10968740|NCT00902538|FG001|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
10968741|NCT00902538|FG002|Participant Flow|OLM 40-AML 10-HCTZ 25|Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
10968742|NCT00902538|FG003|Participant Flow|OLM 40-AML 10-HCTZ 12.5 (Responders)|Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
10968743|NCT00902538|FG004|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
10968744|NCT00902538|FG005|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
10968745|NCT00902538|OG000|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
10968746|NCT00902538|OG001|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
10968747|NCT00902538|OG002|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
10968748|NCT00902538|OG000|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
10968749|NCT00902538|OG001|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
11206688|NCT02237898|BG002|Baseline|Total|Total of all reporting groups
11206689|NCT02237898|FG000|Participant Flow|MoMba Contingency Management|"MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.~The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).~The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.~Most breath tests will be completed remotely."
11206690|NCT02237898|FG001|Participant Flow|Office Contingency Management|"The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.~Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.~Control participants will not have access to the MoMba Live Long app."
11206691|NCT02237898|OG000|Outcome|MoMba Contingency Management|"MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.~The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).~The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.~Most breath tests will be completed remotely."
11206692|NCT02237898|OG001|Outcome|Office Contingency Management|"The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.~Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.~Control participants will not have access to the MoMba Live Long app."
11206693|NCT02237898|OG000|Outcome|Eligible From Screening|Women who were eligible for participation in the study from screening.
11206694|NCT02237898|OG000|Outcome|MoMba Contingency Management|"MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.~The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).~The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process..~Most breath tests will be completed remotely."
11206695|NCT02237898|EG000|Reported Event|MoMba Contingency Management|"MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.~The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).~The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.~Most breath tests will be completed remotely."
11206696|NCT02237898|EG001|Reported Event|Office Contingency Management|"The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.~Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.~Control participants will not have access to the MoMba Live Long app."
10818515|NCT00031590|EG000|Reported Event|Study Treatment|"All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with vincristine. 4 weeks after radiation and vincristine treatment is completed, all subjects will begin 9 cycles (each cycle lasts 6 weeks) of maintenance chemotherapy which will be given as 2 different drug combinations, Regimen A (Lomustine, Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide) which will be given in the following order (total of 54 weeks):1st-Regimen A, 2nd-Regimen A, 3rd-Regimen B, 4th-Regimen A, 5th-Regimen A, 6th-Regimen B, 7th-Regimen A, 8th-Regimen A, 9th-Regimen B Cisplatin: Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only). Cyclophosphamide: Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6"
11206697|NCT02237911|BG000|Baseline|Clinic-based Outpatient Exercise Group|Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
11206698|NCT02237911|BG001|Baseline|Community-based Exercise Group|Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
11206699|NCT02237911|BG002|Baseline|Wait-listed Usual Medical Care|Wait-listed usual medical care - no intervention provided by study.
11206700|NCT02237911|BG003|Baseline|Total|Total of all reporting groups
11206701|NCT02237911|FG000|Participant Flow|Clinic-based Outpatient Exercise Group|Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
11206702|NCT02237911|FG001|Participant Flow|Community-based Exercise Group|Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
11206703|NCT02237911|FG002|Participant Flow|Wait-listed Usual Medical Care|Wait-listed usual medical care - no intervention provided by study.
11206704|NCT02237911|OG000|Outcome|Clinic-based Outpatient Exercise Group|Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
11206705|NCT02237911|OG001|Outcome|Community-based Exercise Group|Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
10818516|NCT00031694|BG000|Baseline|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
10818517|NCT00031694|FG000|Participant Flow|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
11206706|NCT02237911|OG002|Outcome|Wait-listed Usual Medical Care|Wait-listed usual medical care - no intervention provided by study.
11206707|NCT02237911|EG000|Reported Event|Clinic-based Outpatient Exercise Group|Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
11206708|NCT02237911|EG001|Reported Event|Community-based Exercise Group|Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
11206709|NCT02237911|EG002|Reported Event|Wait-listed Usual Medical Care|Wait-listed usual medical care - no intervention provided by study.
11206710|NCT02237950|BG000|Baseline|1% SPL7013 Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks."
11206711|NCT02237950|BG001|Baseline|Placebo Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks"
11206712|NCT02237950|BG002|Baseline|Total|Total of all reporting groups
11206713|NCT02237950|FG000|Participant Flow|1% SPL7013 Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks."
11206714|NCT02237950|FG001|Participant Flow|Placebo Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks"
11206715|NCT02237950|OG000|Outcome|1% SPL7013 Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks."
11206716|NCT02237950|OG001|Outcome|Placebo Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks"
11206717|NCT02237950|EG000|Reported Event|1% SPL7013 Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks."
11206718|NCT02237950|EG001|Reported Event|Placebo Gel|"Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks~Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days~Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks"
11206719|NCT02237989|BG000|Baseline|Paracetamol|"The 1st group includes 19 patients given 1500mg/day paracetamol for three months~paracetamol: 1500 mg"
11206720|NCT02237989|BG001|Baseline|Native Collagen Type 2 + Paracetamol|"The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months~paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)"
11206721|NCT02237989|BG002|Baseline|Total|Total of all reporting groups
11206722|NCT02237989|FG000|Participant Flow|Paracetamol|"The 1st group includes 19 patients given 1500mg/day paracetamol for three months~paracetamol: 1500 mg"
11206723|NCT02237989|FG001|Participant Flow|Native Collagen Type 2 + Paracetamol|"The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months~paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)"
11206724|NCT02237989|OG000|Outcome|Paracetamol|"The 1st group includes 19 patients given 1500mg/day paracetamol for three months~paracetamol: 1500 mg"
11206725|NCT02237989|OG001|Outcome|Native Collagen Type 2 + Paracetamol|"The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months~paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)"
11206726|NCT02237989|EG000|Reported Event|Treatment Group|1500 mg/day acetaminophen and 10 mg/day of native type II collagen
11206727|NCT02237989|EG001|Reported Event|Control Group|1500 mg/day acetaminophen
11206728|NCT02238028|BG000|Baseline|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206729|NCT02238028|FG000|Participant Flow|Wearing Respirator First,Then Not Wearing Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206730|NCT02238028|FG001|Participant Flow|Not Wearing Respirator First,Then Wearing Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
11206731|NCT02238028|OG000|Outcome|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206732|NCT02238028|OG001|Outcome|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
11206733|NCT02238028|OG000|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206734|NCT02238028|OG001|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
11286184|NCT02885025|FG003|Participant Flow|Placebo Pill + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
11206735|NCT02238028|OG000|Outcome|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206736|NCT02238028|OG000|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206737|NCT02238028|OG001|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
11206738|NCT02238028|EG000|Reported Event|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
11206739|NCT02238028|EG001|Reported Event|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
11206740|NCT02238067|BG000|Baseline|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
11206741|NCT02238067|FG000|Participant Flow|Chronic Renal Anemia Participants|Participants with Chronic Kidney Disease (CKD) who were not on dialysis and treated with Erythropoiesis-Stimulating Agents (ESA) according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
11206742|NCT02238067|OG000|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
11206743|NCT02238067|EG000|Reported Event|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
11206744|NCT02238080|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
11206745|NCT02238080|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
11206746|NCT02238080|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
11206747|NCT02238080|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
11206748|NCT02238379|BG000|Baseline|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
11206749|NCT02238379|BG001|Baseline|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
11206750|NCT02238379|BG002|Baseline|Total|Total of all reporting groups
11206751|NCT02238379|FG000|Participant Flow|Oxytocin First, Then Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
11206752|NCT02238379|FG001|Participant Flow|Placebo First, Then Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
11206753|NCT02238379|OG000|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
11206754|NCT02238379|OG001|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
11206755|NCT02238379|EG000|Reported Event|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
11206756|NCT02238379|EG001|Reported Event|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
11206757|NCT02238483|BG000|Baseline|AZD7624|Active treatment 2 x 0.5mg inhalation qd
11206758|NCT02238483|BG001|Baseline|Placebo|Matching placebo comparator
11206759|NCT02238483|BG002|Baseline|Total|Total of all reporting groups
11206760|NCT02238483|FG000|Participant Flow|AZD7624|Active treatment 2 x 0.5mg inhalation qd
10818518|NCT00031694|OG000|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
10818519|NCT00031694|OG000|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV"
10847901|NCT00286494|OG000|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
11206761|NCT02238483|FG001|Participant Flow|Placebo|Matching placebo comparator
11206762|NCT02238483|OG000|Outcome|AZD7624|Active treatment 2 x 0.5mg inhalation qd
11206763|NCT02238483|OG001|Outcome|Placebo|Matching placebo comparator
11206764|NCT02238483|EG000|Reported Event|AZD7624|Active treatment 2 x 0.5mg inhalation qd
11206765|NCT02238483|EG001|Reported Event|Placebo|Matching placebo comparator
11206766|NCT02238626|BG000|Baseline|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily."
11206767|NCT02238626|BG001|Baseline|MN-166 (Early ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily."
11206768|NCT02238626|BG002|Baseline|Placebo (for MN-166) (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166) riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years of Screening."
11206769|NCT02238626|BG003|Baseline|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166 riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before screening."
11206770|NCT02238626|BG004|Baseline|Total|Total of all reporting groups
11206771|NCT02238626|FG000|Participant Flow|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset is 5 years or less."
11206772|NCT02238626|FG001|Participant Flow|MN-166 (Early ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset is 5 years or less."
11206773|NCT02238626|FG002|Participant Flow|Placebo (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset more than 5 years, but less than 10 years."
11206774|NCT02238626|FG003|Participant Flow|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset is less than 10 years, but more than 5 years."
11206775|NCT02238626|OG000|Outcome|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years."
11206776|NCT02238626|OG001|Outcome|MN-166|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years."
11206777|NCT02238626|OG002|Outcome|Placebo (for MN-166) (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before Screening."
11206778|NCT02238626|OG003|Outcome|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before Screening."
11206779|NCT02238626|OG000|Outcome|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset within 5 years of Screening."
11206780|NCT02238626|OG001|Outcome|MN-166 (Early ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset within 5 years of screening."
11286185|NCT02885025|OG000|Outcome|BSE + Nasal Fluticasone|patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
11206781|NCT02238626|OG002|Outcome|Placebo (for MN-166) (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years of Screening."
11206782|NCT02238626|OG003|Outcome|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before screening."
11206783|NCT02238626|OG000|Outcome|Placebo (for MN-166) Early ALS Cohort|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years of screening."
11206784|NCT02238626|OG001|Outcome|MN-166 (Early ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years of screening."
11206785|NCT02238626|OG002|Outcome|Placebo (for MN-166) (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166) riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years of Screening."
11206786|NCT02238626|OG003|Outcome|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166 riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before screening."
11206787|NCT02238626|OG000|Outcome|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years of screening."
11206788|NCT02238626|OG000|Outcome|Placebo (for MN-166)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily."
11206789|NCT02238626|OG001|Outcome|MN-166|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily."
10847902|NCT00286494|OG001|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
11206790|NCT02238626|EG000|Reported Event|Placebo (for MN-166) (Early ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166)~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years of screening."
11206791|NCT02238626|EG001|Reported Event|MN-166 (Early ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166~riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS onset within 5 years of screening."
11206792|NCT02238626|EG002|Reported Event|Placebo (for MN-166) (Advanced ALS Cohort)|"Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months.~Placebo (for MN-166) riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years of Screening."
11206793|NCT02238626|EG003|Reported Event|MN-166 (Advanced ALS Cohort)|"MN-166 10 mg tablets (up to 60 mg/day) by mouth 2-3 times a day plus 50 mg riluzole 2 times a day by mouth for 6 months.~MN-166 riluzole: Patient is given 50 mg riluzole twice daily. Patient ALS symptom onset between 5 and 10 years before screening."
11206794|NCT02238782|BG000|Baseline|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
11206795|NCT02238782|FG000|Participant Flow|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
11206796|NCT02238782|OG000|Outcome|Selumetinib|Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
11206797|NCT02238782|EG000|Reported Event|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
11206798|NCT02238847|BG000|Baseline|WallFlex Biliary RX Fully Covered Stent System|"Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206799|NCT02238847|BG001|Baseline|WallFlex Biliary RX Uncovered Stent System|"Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206800|NCT02238847|BG002|Baseline|Total|Total of all reporting groups
11206801|NCT02238847|FG000|Participant Flow|WallFlex Biliary RX Fully Covered Stent System|"Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206802|NCT02238847|FG001|Participant Flow|WallFlex Biliary RX Uncovered Stent System|"Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206803|NCT02238847|OG000|Outcome|WallFlex Biliary RX Fully Covered Stent System|"Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206804|NCT02238847|OG001|Outcome|WallFlex Biliary RX Uncovered Stent System|"Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206805|NCT02238847|EG000|Reported Event|WallFlex Biliary RX Fully Covered Stent System|"Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206806|NCT02238847|EG001|Reported Event|WallFlex Biliary RX Uncovered Stent System|"Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).~Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System~WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System"
11206807|NCT02238925|BG000|Baseline|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
11206808|NCT02238925|FG000|Participant Flow|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
11206809|NCT02238925|OG000|Outcome|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
11206810|NCT02238925|EG000|Reported Event|CPX-351|"Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):~Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.~Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.~Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.~CPX-351"
11206811|NCT02238977|BG000|Baseline|Fluoxetine|"Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.~Fluoxetine: Antidepressant"
11206812|NCT02238977|BG001|Baseline|Bupropion|"Bupropion sustained release (SR) 150 mg orally twice per week~Bupropion: Antidepressant"
11206813|NCT02238977|BG002|Baseline|Total|Total of all reporting groups
11206814|NCT02238977|FG000|Participant Flow|Fluoxetine|"Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.~Fluoxetine: Antidepressant"
11206815|NCT02238977|FG001|Participant Flow|Bupropion|"Bupropion sustained release (SR) 150 mg orally twice per week~Bupropion: Antidepressant"
11206816|NCT02238977|OG000|Outcome|Bupropion|"Bupropion sustained release (SR) 150 mg orally twice per week~Bupropion: Antidepressant"
11206817|NCT02238977|OG001|Outcome|Fluoxetine|"Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.~Fluoxetine: Antidepressant"
11206818|NCT02238977|EG000|Reported Event|Fluoxetine|"Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.~Fluoxetine: Antidepressant"
11206819|NCT02238977|EG001|Reported Event|Bupropion|"Bupropion sustained release (SR) 150 mg orally twice per week~Bupropion: Antidepressant"
11206820|NCT02239094|BG000|Baseline|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
11206821|NCT02239094|FG000|Participant Flow|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
11206822|NCT02239094|OG000|Outcome|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
11206823|NCT02239094|EG000|Reported Event|Lurasidone (Latuda)|"All study participants will receive open-label Latuda.~Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder"
11206824|NCT02239120|BG000|Baseline|Dabigatran Etexilate 110 or 150 Milligram (mg)|Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
11206825|NCT02239120|BG001|Baseline|Acetylsalicylic Acid, Aspirin (ASA) 100 mg|Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
11206826|NCT02239120|BG002|Baseline|Total|Total of all reporting groups
11206827|NCT02239120|FG000|Participant Flow|Dabigatran Etexilate 110 or 150 Milligram (mg)|Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
11206828|NCT02239120|FG001|Participant Flow|Acetylsalicylic Acid, Aspirin (ASA) 100 mg|Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
11206829|NCT02239120|OG000|Outcome|Dabigatran Etexilate 110 or 150 Milligram (mg)|Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
11206830|NCT02239120|OG001|Outcome|Acetylsalicylic Acid, Aspirin (ASA) 100 mg|Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
11206831|NCT02239120|EG000|Reported Event|Dabigatran Etexilate 110 or 150 Milligram (mg)|Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to <50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged <75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.
11206832|NCT02239120|EG001|Reported Event|Acetylsalicylic Acid, Aspirin (ASA) 100 mg|Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.
11206833|NCT02239224|BG000|Baseline|Cohort 1: ATYR1940 0.3 mg/kg|Participants received ATYR1940 0.3 mg/kg IV infusion once weekly for 4 weeks.
11206834|NCT02239224|BG001|Baseline|Cohort 2: ATYR1940 1.0 mg/kg|Participants received ATYR1940 1.0 mg/kg IV infusion once weekly for 4 weeks.
11206835|NCT02239224|BG002|Baseline|Cohort 3: ATYR1940 3.0 mg/kg|Participants received ATYR1940 3.0 mg/kg IV infusion once weekly for 12 weeks.
11206836|NCT02239224|BG003|Baseline|Placebo|Participants received placebo matched to ATYR1940 IV infusion once weekly for 4 weeks in Cohorts 1 and 2 and for 12 weeks in Cohort 3.
11206837|NCT02239224|BG004|Baseline|Total|Total of all reporting groups
10818520|NCT00031694|EG000|Reported Event|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
10818521|NCT00032487|BG000|Baseline|Arm 1/Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
10818522|NCT00032487|BG001|Baseline|Arm 2/Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
10818523|NCT00032487|BG002|Baseline|Total|Total of all reporting groups
11206838|NCT02239224|FG000|Participant Flow|Cohort 1: ATYR1940 0.3 mg/kg|Participants received ATYR1940 0.3 milligrams/kilograms (mg/kg) intravenous (IV) infusion once weekly for 4 weeks.
11206839|NCT02239224|FG001|Participant Flow|Cohort 2: ATYR1940 1.0 mg/kg|Participants received ATYR1940 1.0 mg/kg IV infusion once weekly for 4 weeks.
11206840|NCT02239224|FG002|Participant Flow|Cohort 3: ATYR1940 3.0 mg/kg|Participants received ATYR1940 3.0 mg/kg IV infusion once weekly for 12 weeks.
11206841|NCT02239224|FG003|Participant Flow|Placebo|Participants received placebo matched to ATYR1940 IV infusion once weekly for 4 weeks in Cohorts 1 and 2 and for 12 weeks in Cohort 3.
11206842|NCT02239224|OG000|Outcome|Cohort 1: ATYR1940 0.3 mg/kg|Participants received ATYR1940 0.3 mg/kg IV infusion once weekly for 4 weeks.
11206843|NCT02239224|OG001|Outcome|Cohort 2: ATYR1940 1.0 mg/kg|Participants received ATYR1940 1.0 mg/kg IV infusion once weekly for 4 weeks.
11206844|NCT02239224|OG002|Outcome|Cohort 3: ATYR1940 3.0 mg/kg|Participants received ATYR1940 3.0 mg/kg IV infusion once weekly for 12 weeks.
11206845|NCT02239224|OG003|Outcome|Placebo|Participants received placebo matched to ATYR1940 IV infusion once weekly for 4 weeks in Cohorts 1 and 2 and for 12 weeks in Cohort 3.
11206846|NCT02239224|EG000|Reported Event|Cohort 1: ATYR1940 0.3 mg/kg|Participants received ATYR1940 0.3 mg/kg IV infusion once weekly for 4 weeks.
11206847|NCT02239224|EG001|Reported Event|Cohort 2: ATYR1940 1.0 mg/kg|Participants received ATYR1940 1.0 mg/kg IV infusion once weekly for 4 weeks.
11206848|NCT02239224|EG002|Reported Event|Cohort 3: ATYR1940 3.0 mg/kg|Participants received ATYR1940 3.0 mg/kg IV infusion once weekly for 12 weeks.
11206849|NCT02239224|EG003|Reported Event|Placebo|Participants received placebo matched to ATYR1940 IV infusion once weekly for 4 weeks in Cohorts 1 and 2 and for 12 weeks in Cohort 3.
11206850|NCT02239263|BG000|Baseline|N6 Input Processing Features - SNR-NR & SCAN|Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)
11206851|NCT02239263|FG000|Participant Flow|N6 Input Processing Features - SNR-NR & SCAN|Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)
11206852|NCT02239263|OG000|Outcome|N6 Input Processing Features - SNR|Endpoint 1: Assessment of Nucleus 6 sound processing feature SNR-NR
10818524|NCT00032487|FG000|Participant Flow|Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
11206853|NCT02239263|OG000|Outcome|N6 Input Processing Features|Endpoint 1: Assessment of Nucleus 6 sound processing feature SCAN
11206854|NCT02239263|EG000|Reported Event|N6 Input Processing Features - SNR-NR|Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1)
11206855|NCT02239263|EG001|Reported Event|N6 Input Processing Features - SCAN|Testing of the Nucleus 6 sound processing SCAN (endpoint 2)
11206856|NCT02239289|BG000|Baseline|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
11206857|NCT02239289|FG000|Participant Flow|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
11206858|NCT02239289|OG000|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
11206859|NCT02239289|EG000|Reported Event|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
11206860|NCT02239328|BG000|Baseline|Lung Cancer, Esophageal Cancer|Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
11206861|NCT02239328|FG000|Participant Flow|Lung Cancer, Esophageal Cancer|Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
11206862|NCT02239328|OG000|Outcome|Lung Cancer, Esophageal Cancer|Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
11286186|NCT02885025|OG001|Outcome|BSE + Normal Saline Nasal Spray|Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
11206863|NCT02239328|EG000|Reported Event|Lung Cancer, Esophageal Cancer|Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
11206864|NCT02239380|BG000|Baseline|Lorazepam|Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.
11206865|NCT02239380|FG000|Participant Flow|Lorazepam|Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.
11206866|NCT02239380|OG000|Outcome|Lorazepam|Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.
11206867|NCT02239380|EG000|Reported Event|Lorazepam|Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.
11206868|NCT02239510|BG000|Baseline|Senna|"1 capsule (50 mg) Senna daily for 12 weeks~Senna: 1 capsule (50 mg) Senna daily for 12 weeks"
11206869|NCT02239510|BG001|Baseline|Linzess|"1 capsule (145 mcg) once daily for 12 weeks~Linzess: 1 capsule (145 mcg) of Linzess once daily for 12 weeks"
11206870|NCT02239510|BG002|Baseline|Total|Total of all reporting groups
11206871|NCT02239510|FG000|Participant Flow|Senna|Patients who received Senna
11206872|NCT02239510|FG001|Participant Flow|Lizness|Patients who received Lizness
11206873|NCT02239510|OG000|Outcome|Senna|Patients who received Senna
11206874|NCT02239510|OG001|Outcome|Lizness|Patients who received Lizness
11206875|NCT02239510|EG000|Reported Event|Senna|Patients who received Senna
11206876|NCT02239510|EG001|Reported Event|Linzess|Patients who received Linzess
11206877|NCT02239536|BG000|Baseline|Hot Snare Polypectomy|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique~hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps"
10818525|NCT00032487|FG001|Participant Flow|Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
10818526|NCT00032487|OG000|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
10847903|NCT00286494|OG002|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
11206878|NCT02239536|BG001|Baseline|Hot Snare Polypectomy(Saline Injection)|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique~hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps"
11206879|NCT02239536|BG002|Baseline|Total|Total of all reporting groups
11206880|NCT02239536|FG000|Participant Flow|Hot Snare Polypectomy|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique~hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps"
11206881|NCT02239536|FG001|Participant Flow|Hot Snare Polypectomy(Saline Injection)|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique~hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps"
11206882|NCT02239536|OG000|Outcome|Hot Snare Polypectomy|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique~hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps"
11206883|NCT02239536|OG001|Outcome|Hot Snare Polypectomy(Saline Injection)|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique~hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps"
11206884|NCT02239536|EG000|Reported Event|Hot Snare Polypectomy|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique~hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps"
11206885|NCT02239536|EG001|Reported Event|Hot Snare Polypectomy(Saline Injection)|"Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique~hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps"
11206886|NCT02239562|BG000|Baseline|SAD sPIF 0.1|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1
10818527|NCT00032487|OG001|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
10818528|NCT00032487|EG000|Reported Event|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
10818529|NCT00032487|EG001|Reported Event|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
10818530|NCT00032591|BG000|Baseline|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
10818531|NCT00032591|BG001|Baseline|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
10818532|NCT00032591|BG002|Baseline|Total|Total of all reporting groups
10818533|NCT00032591|FG000|Participant Flow|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
10818534|NCT00032591|FG001|Participant Flow|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
10818535|NCT00032591|OG000|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
10818536|NCT00032591|OG001|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
10818537|NCT00032591|EG000|Reported Event|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
10818538|NCT00032591|EG001|Reported Event|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
10818539|NCT00032630|BG000|Baseline|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
10818540|NCT00032630|BG001|Baseline|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
10818541|NCT00032630|BG002|Baseline|Total|Total of all reporting groups
10818542|NCT00032630|FG000|Participant Flow|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
10818543|NCT00032630|FG001|Participant Flow|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
10818544|NCT00032630|OG000|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
10818545|NCT00032630|OG001|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
10818546|NCT00032630|EG000|Reported Event|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
10818547|NCT00032630|EG001|Reported Event|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
10818548|NCT00033371|BG000|Baseline|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
10818549|NCT00033371|BG001|Baseline|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
10818550|NCT00033371|BG002|Baseline|Total|Total of all reporting groups
10818551|NCT00033371|FG000|Participant Flow|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
10818552|NCT00033371|FG001|Participant Flow|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
10818553|NCT00033371|OG000|Outcome|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
10818554|NCT00033371|OG001|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
10818555|NCT00033371|OG000|Outcome|Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic|Celecoxib, 400 mg p.o. BID plus DFMO placebo ( 60 participants with evaluable colon or rectum)
10818556|NCT00033371|OG001|Outcome|Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou|"Celecoxib, 400 mg p.o. BID plus DFMO 0.5 gm/m2/day rounded down to the nearest 250mg dose ( 60 participants with evaluable colon or rectum). "
10818557|NCT00033371|OG000|Outcome|Arm I: Celecoxib and Placebo|Celecoxib, 400 mg p.o. BID plus DFMO placebo ( 60 participants with evaluable colon or rectum)
10818558|NCT00033371|OG001|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib, 400 mg p.o. BID plus DFMO 0.5 gm/m2/day rounded down to the nearest 250mg dose ( 60 participants with evaluable colon or rectum).
10818559|NCT00033371|EG000|Reported Event|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
10818560|NCT00033371|EG001|Reported Event|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
11206887|NCT02239562|BG001|Baseline|SAD sPIF 0.5|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1
10818561|NCT00033514|BG000|Baseline|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
10818562|NCT00033514|BG001|Baseline|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
10818563|NCT00033514|BG002|Baseline|Total|Total of all reporting groups
10818564|NCT00033514|FG000|Participant Flow|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
10818565|NCT00033514|FG001|Participant Flow|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
10818566|NCT00033514|OG000|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
10818567|NCT00033514|OG000|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
10818568|NCT00033514|OG000|Outcome|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride:150 mg daily."
10818569|NCT00033514|OG000|Outcome|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
10818570|NCT00033514|EG000|Reported Event|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
10818571|NCT00033540|BG000|Baseline|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
10818572|NCT00033540|FG000|Participant Flow|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
10818573|NCT00033540|OG000|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
10818574|NCT00033540|OG000|Outcome|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
10818575|NCT00033540|EG000|Reported Event|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
10818576|NCT00033631|BG000|Baseline|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
10818577|NCT00033631|BG001|Baseline|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
10818578|NCT00033631|BG002|Baseline|Total|Total of all reporting groups
10818579|NCT00033631|FG000|Participant Flow|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
10818580|NCT00033631|FG001|Participant Flow|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
10818581|NCT00033631|OG000|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
10818582|NCT00033631|OG001|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
10818583|NCT00033631|OG001|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
10818584|NCT00033631|EG000|Reported Event|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
10968750|NCT00902538|OG000|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
10968751|NCT00902538|OG001|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
10968752|NCT00902538|EG000|Reported Event|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
10968753|NCT00902538|EG001|Reported Event|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
10968754|NCT00902538|EG002|Reported Event|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
10968755|NCT00902564|BG000|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968756|NCT00902564|FG000|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968757|NCT00902564|OG000|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968758|NCT00902564|EG000|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
10968759|NCT00902577|BG000|Baseline|Newly Diagnosed Glioblastoma Multiforme Patients|42 eligible, consented patients with newly diagnosed GBM who received both FMISO-PRT and MRI imaging two weeks before initiation of chemoradiotherapy with temozolomide
10968760|NCT00902577|FG000|Participant Flow|Newly Diagnosed Glioblastoma Multiforme Patients|Patients with Newly diagnosed GBM scheduled to have FMISO Positron Emission Tomography (PET) two weeks before initiation of chemoradiotherapy with temozolomide, with diagnostic DCE/DSE/DWI MRI
10968761|NCT00902577|OG000|Outcome|Evaluable|42 participants with imaging (FMISO-PET, DCE/DSC/DWI MRI)
10968762|NCT00902577|OG001|Outcome|FMISO-PET|Quantitative PET measurements Hypoxic Volume (HV) Max tumor:blood ratio (TBmax) Peak Standardized uptake Values (SUVpeak)
10968763|NCT00902577|OG002|Outcome|DSC MRI|"Quantitative DSC measurements:~Normalized rCBV [Relative cerebral blood volume] Normalized rCBF[Relative cerebral blood flow]"
10968764|NCT00902577|OG003|Outcome|DCE MRI|Quantitative DCE measurements Mean vascular permeability (ktrans) Median Ktrans
10968765|NCT00902577|OG004|Outcome|DWI-MRI|Apparent diffusion coefficient (ADC) Low and High
10968766|NCT00902577|OG000|Outcome|FMISO Reproducibility|Participants with two FMISO PET scans within 1 to 7 days of each other and prior to Visit 2 to test reproducibility of FMISO PET removing 5 participants with protocol variations which could affect the SUV measurements
10968767|NCT00902577|OG000|Outcome|DSC MRI|Participant with DSC MRI
10968768|NCT00902577|OG000|Outcome|nrCBV|17 participants with measured MRS markers and nRCBV: relative cerebral blood volume, corrected for leakage effects and normalized to normal-appearing white matter;
10968769|NCT00902577|OG001|Outcome|nCBF|17 participants with measured MRS markers and nCBF: cerebral blood flow, normalized to normal-appearing white matter;
10968770|NCT00902577|OG002|Outcome|Median K-trans|17 participants with measured MRS markers and k-trans: vascular permeability
10968771|NCT00902577|OG003|Outcome|SUV Max|17 participants with measured MRS markers and SUVmax: standardized uptake value
10968772|NCT00902577|OG000|Outcome|Newly Diagnosed Glioblastoma Multiforme Patients|42 eligible, consented patients with newly diagnosed GBM who received both FMISO-PRT and MRI imaging two weeks before initiation of chemoradiotherapy with temozolomide
10968773|NCT00902577|OG000|Outcome|FMISO-PET|Quantitative PET measurements Max tumor:blood ratio (TBmax) Peak Standardized uptake Values (SUVpeak)
10968774|NCT00902577|OG000|Outcome|DWI-MRI|Apparent diffusion coefficient (ADC) Low and High
10968775|NCT00902577|OG000|Outcome|DSC MRI|"Quantitative DSC measurements:~Normalized rCBV [Relative cerebral blood volume] Normalized rCBF[Relative cerebral blood flow]"
10968776|NCT00902577|OG000|Outcome|DCE MRI|Quantitative DCE measurements Mean vascular permeability (ktrans) Median Ktrans
10968777|NCT00902577|EG000|Reported Event|Evaluable Cases|Patients with Newly diagnosed GBM scheduled to have FMISO PET/CT two weeks before initiation of chemoradiotherapy with temozolomide.
10968778|NCT00902577|EG001|Reported Event|Diagnostic PET (Using FMISO)|Patients with Newly diagnosed GBM who have FMISO PET/CT Imaging two weeks before initiation of chemoradiotherapy with temozolomide.
11206888|NCT02239562|BG002|Baseline|SAD sPIF 1.0|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1
11206889|NCT02239562|BG003|Baseline|MAD sPIF 0.1|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.1 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11286187|NCT02885025|OG002|Outcome|Placebo Pill + Nasal Fluticasone|Patients received placebo tablet and nasal fluticasone for 3 weeks.
10968779|NCT00902577|EG002|Reported Event|Diagnostic MRI (DCE MRI)|Patients with Newly diagnosed GBM who have FMISO PET/CT and Dynamic Contrast Enhanced (DCE) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.
10968780|NCT00902577|EG003|Reported Event|Diagnostic MRI (DSE MRI)|Patients with Newly diagnosed GBM who have FMISO PET/CT and Dynamic Susceptibility Contrast Enhanced (DSC) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.
10968781|NCT00902577|EG004|Reported Event|Diagnostic MRI (DWI MRI)|Patients with Newly diagnosed GBM who have FMISO PET/CT and Diffusion-Weighted Imaging (DWI) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.
10968782|NCT00902746|BG000|Baseline|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
11206890|NCT02239562|BG004|Baseline|MAD sPIF 0.5|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 0.5 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206891|NCT02239562|BG005|Baseline|MAD sPIF 1.0|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug : placebo) to multiple 1.0 mg/kg sPIF doses of sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206892|NCT02239562|BG006|Baseline|Total|Total of all reporting groups
11206893|NCT02239562|FG000|Participant Flow|SAD sPIF 0.1|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1
11206894|NCT02239562|FG001|Participant Flow|SAD sPIF 0.5|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1
11206895|NCT02239562|FG002|Participant Flow|SAD sPIF 1.0|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1
10818585|NCT00033631|EG001|Reported Event|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
10818586|NCT00033657|BG000|Baseline|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
11206896|NCT02239562|FG003|Participant Flow|MAD sPIF 0.1|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5
11206897|NCT02239562|FG004|Participant Flow|MAD sPIF 0.5|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5
11206898|NCT02239562|FG005|Participant Flow|MAD sPIF 1.0|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5
11206899|NCT02239562|OG000|Outcome|SAD sPIF 0.1|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.1 mg/kg sPIF or Placebo Day 1
11206900|NCT02239562|OG001|Outcome|SAD sPIF 0.5|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 0.5 mg/kg sPIF or Placebo Day 1
11206901|NCT02239562|OG002|Outcome|SAD sPIF 1.0|single ascending dose (SAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) as follows: Single SQ dose 1.0 mg/kg sPIF or Placebo Day 1
11206902|NCT02239562|OG003|Outcome|MAD sPIF 0.1|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.1 mg/kg sPIF or Placebo Days 1-5
11206903|NCT02239562|OG004|Outcome|MAD sPIF 0.5|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 0.5 mg/kg sPIF or Placebo Days 1-5
11206904|NCT02239562|OG005|Outcome|MAD sPIF 1.0|multiple ascending dose (MAD) 3 patients with normal LFTs and 3 patients with abnormal LFTs randomized in a 2:1 ratio (active drug:placebo) to multiple doses of sPIF SQ 1X day for 5 consecutive days (Days 1 to 5) Cohort 1: SQ 1.0 mg/kg sPIF or Placebo Days 1-5
11286188|NCT02885025|OG003|Outcome|Placebo Pill + Normal Saline Nasal Spray|Patients received placebo tablet and normal saline nasal spray for 3 weeks
10818587|NCT00033657|BG001|Baseline|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
11206905|NCT02239562|EG000|Reported Event|Single Ascending Dose Placebo|Single dose of placebo administered subcutaneously (Day 1)
10818588|NCT00033657|BG002|Baseline|Total|Total of all reporting groups
10847904|NCT00286494|EG000|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
11206906|NCT02239562|EG001|Reported Event|Single Ascending Dose 0.1|Single dose 0.1 mg/kg sPIF administered subcutaneously (Day 1)
11206907|NCT02239562|EG002|Reported Event|Single Ascending Dose 0.5|Single dose 0.5 mg/kg sPIF administered subcutaneously (Day 1)
11206908|NCT02239562|EG003|Reported Event|Single Ascending Dose 1.0|Single dose 1.0 mg/kg sPIF administered subcutaneously (Day 1)
11206909|NCT02239562|EG004|Reported Event|Multiple Ascending Placebo|Placebo administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206910|NCT02239562|EG005|Reported Event|Multiple Ascending Dose 0.1|0.1 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206911|NCT02239562|EG006|Reported Event|Multiple Ascending Dose 0.5|0.5 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206912|NCT02239562|EG007|Reported Event|Multiple Ascending Dose 1.0|1.0 mg/kg sPIF administered subcutaneously once a day for 5 consecutive days (Days 1 to 5)
11206913|NCT02239601|BG000|Baseline|Physical Therapy|"4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.~Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment"
10968783|NCT00902746|FG000|Participant Flow|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
10968784|NCT00902746|OG000|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
10968785|NCT00902746|EG000|Reported Event|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
10968786|NCT00902850|BG000|Baseline|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
10968787|NCT00902850|BG001|Baseline|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
10968788|NCT00902850|BG002|Baseline|Total|Total of all reporting groups
10968789|NCT00902850|FG000|Participant Flow|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
10968790|NCT00902850|FG001|Participant Flow|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
10968791|NCT00902850|OG000|Outcome|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
10968792|NCT00902850|OG001|Outcome|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
11206914|NCT02239601|BG001|Baseline|Control|treatment per usual
10968793|NCT00902850|EG000|Reported Event|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
10968794|NCT00902850|EG001|Reported Event|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
10968795|NCT00903032|BG000|Baseline|Patient Centered Intervention|The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
10968796|NCT00903032|BG001|Baseline|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
10968797|NCT00903032|BG002|Baseline|Total|Total of all reporting groups
10968798|NCT00903032|FG000|Participant Flow|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re"
10968799|NCT00903032|FG001|Participant Flow|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
11206915|NCT02239601|BG002|Baseline|Total|Total of all reporting groups
11206916|NCT02239601|FG000|Participant Flow|Physical Therapy|"4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.~Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment"
11206917|NCT02239601|FG001|Participant Flow|Control|treatment as usual
11206918|NCT02239601|OG000|Outcome|Physical Therapy|"4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.~Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment"
10818589|NCT00033657|FG000|Participant Flow|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
10818590|NCT00033657|FG001|Participant Flow|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
10818591|NCT00033657|OG000|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
10818592|NCT00033657|OG001|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
10818593|NCT00033657|EG000|Reported Event|Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
10818594|NCT00033657|EG001|Reported Event|Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
10818595|NCT00033657|EG002|Reported Event|Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)|Adjuvant chemotherapy toxicities in treated patients
10818596|NCT00033657|EG003|Reported Event|Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)|
10818597|NCT00033917|BG000|Baseline|Indomethacin|subjects randomized to early low dose indomethacin
10818598|NCT00033917|BG001|Baseline|Placebo|Group randomized to an equal volume of placebo
10818599|NCT00033917|BG002|Baseline|Total|Total of all reporting groups
10818600|NCT00033917|FG000|Participant Flow|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
10818601|NCT00033917|FG001|Participant Flow|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
10818602|NCT00033917|OG000|Outcome|Indomethacin|subjects randomized to early low dose indomethacin
10818603|NCT00033917|OG001|Outcome|Placebo|Group randomized to an equal volume of placebo
10818604|NCT00033917|OG000|Outcome|Indomethacin - no IVH|Subjects randomized to indomethacin and had no IVH
10818605|NCT00033917|OG001|Outcome|Indomethacin - IVH|Randomized to indomethacin; had IVH
10818606|NCT00033917|OG002|Outcome|Placebo - no IVH|Randomized to placebo - no IVH
10818607|NCT00033917|OG003|Outcome|Placebo - IVH|Randomized to placebo; had IVH
10818608|NCT00033917|EG000|Reported Event|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
10818609|NCT00033917|EG001|Reported Event|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
10818610|NCT00035555|BG000|Baseline|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818611|NCT00035555|BG001|Baseline|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10847905|NCT00286494|EG001|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
10818612|NCT00035555|BG002|Baseline|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818613|NCT00035555|BG003|Baseline|Total|Total of all reporting groups
10818614|NCT00035555|FG000|Participant Flow|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818615|NCT00035555|FG001|Participant Flow|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818616|NCT00035555|FG002|Participant Flow|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818617|NCT00035555|OG000|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818618|NCT00035555|OG001|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818619|NCT00035555|OG002|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818620|NCT00035555|OG001|Outcome|Belatacept:Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10847906|NCT00286494|EG002|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
11206919|NCT02239601|OG001|Outcome|Control|chemotherapy as usual without physical therapy
10818621|NCT00035555|EG000|Reported Event|Belatacept: Less-intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818622|NCT00035555|EG001|Reported Event|Belatacept: More-intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818623|NCT00035555|EG002|Reported Event|Cyclosporin Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
10818624|NCT00035815|BG000|Baseline|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
10818625|NCT00035815|BG001|Baseline|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
10818626|NCT00035815|BG002|Baseline|Total|Total of all reporting groups
10818627|NCT00035815|FG000|Participant Flow|IGF-1|The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
10818628|NCT00035815|FG001|Participant Flow|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
10818629|NCT00035815|OG000|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
10818630|NCT00035815|OG001|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
10818631|NCT00035815|EG000|Reported Event|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
10818632|NCT00035815|EG001|Reported Event|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
11206920|NCT02239601|OG000|Outcome|Physical Therapy|"4 Physical therapy treatment sessions provided prior to chemotherapy along with a home program to continue throughout the trial.~Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy (baseline) including nerve gliding exercises, education and splinting. A home program was provided and continued throughout chemotherapy treatment."
11206921|NCT02239601|OG001|Outcome|Control Group|Chemotherapy as usual- no physical therapy intervention
10818633|NCT00035932|BG000|Baseline|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818634|NCT00035932|BG001|Baseline|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818635|NCT00035932|BG002|Baseline|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818636|NCT00035932|BG003|Baseline|Total|Total of all reporting groups
10818637|NCT00035932|FG000|Participant Flow|ATV 300 mg / RTV|"atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818638|NCT00035932|FG001|Participant Flow|ATV 400 mg / SQV|"ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818639|NCT00035932|FG002|Participant Flow|LPV / RTV|"lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818640|NCT00035932|OG000|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
11206922|NCT02239601|OG001|Outcome|Control|treatment as usual
11206923|NCT02239601|OG000|Outcome|Active|Patients that reported being active a least 4 days per week (30 minutes minimum) on 2 or more of the 4 re-assessment visits
11206924|NCT02239601|OG001|Outcome|Less Active|Any exercise that falls below the cut-off for active
10968800|NCT00903032|OG000|Outcome|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
10968801|NCT00903032|OG001|Outcome|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
10968802|NCT00903032|EG000|Reported Event|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
10968803|NCT00903032|EG001|Reported Event|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
10970620|NCT00911300|FG000|Participant Flow|Fondaparinux|For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
10970621|NCT00911300|FG001|Participant Flow|Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)|Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
10970622|NCT00911300|OG000|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
10970623|NCT00911300|OG001|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
11244383|NCT02510664|OG000|Outcome|Provider|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
11286189|NCT02885025|OG000|Outcome|BSE + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis."
10818641|NCT00035932|OG001|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
11206925|NCT02239601|EG000|Reported Event|Physical Therapy|"4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.~Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment"
11206926|NCT02239601|EG001|Reported Event|Control|treatment as usual
11206927|NCT02239640|BG000|Baseline|Overall Study|Subjects enrolled
10818642|NCT00035932|OG002|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818643|NCT00035932|OG001|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
10818644|NCT00035932|OG000|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
10818645|NCT00035932|OG001|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
10818646|NCT00035932|OG000|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
10818647|NCT00035932|OG001|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
10818648|NCT00035932|EG000|Reported Event|ATV300/RTV|atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
10818649|NCT00035932|EG001|Reported Event|ATV400/SQV|ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
10818650|NCT00035932|EG002|Reported Event|LPV/RTV|lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
11206928|NCT02239640|FG000|Participant Flow|Non-Randomized|Observation registry.
10818651|NCT00036270|BG000|Baseline|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
10818652|NCT00036270|BG001|Baseline|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
10818653|NCT00036270|BG002|Baseline|Total|Total of all reporting groups
10818654|NCT00036270|FG000|Participant Flow|Exemestane|Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
10818655|NCT00036270|FG001|Participant Flow|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
10818656|NCT00036270|OG000|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
10818657|NCT00036270|OG001|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
10818658|NCT00036270|EG000|Reported Event|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
10818659|NCT00036270|EG001|Reported Event|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years
10818660|NCT00036569|BG000|Baseline|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
10818661|NCT00036569|FG000|Participant Flow|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
10818662|NCT00036569|OG000|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
10818663|NCT00036569|OG000|Outcome|QOL Score at Baseline|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
10818664|NCT00036569|OG001|Outcome|QOL Score at Follow-up|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
10818665|NCT00036569|EG000|Reported Event|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
11206929|NCT02239640|OG000|Outcome|Successful Revascularization|Successful reperfusion (mTICI 2b-3) per imaging core lab
11206930|NCT02239640|OG000|Outcome|Neurological Deterioration|Neurological Deterioration up to 90 days (any event causing neurological deterioration; defined as ≥ 4 points worsening from baseline on the NIHSS scale).
11206931|NCT02239640|OG000|Outcome|All-cause Mortality|All cause mortality up to 90 days post index stroke procedure
11206932|NCT02239640|OG000|Outcome|mRS at 90 Days|mRS (0-2) at 90 Days
11206933|NCT02239640|OG000|Outcome|Study Device-related SAEs (Site Reported)|Incidence of study device-related SAEs <= 90 days post procedure
11206934|NCT02239640|OG000|Outcome|Time to Revascularization|Puncture to TICI 2b-3 or completion
11206935|NCT02239640|OG000|Outcome|Procedure-related SAEs (Site Reported)|Incidence of procedure-related SAEs <= 90 days post procedure
11206936|NCT02239640|EG000|Reported Event|Adverse Events|Serious adverse events reported per protocol during the study
10968804|NCT00903162|BG000|Baseline|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
10968805|NCT00903162|FG000|Participant Flow|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
10968806|NCT00903162|OG000|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
10968807|NCT00903162|EG000|Reported Event|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
10968808|NCT00903175|BG000|Baseline|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
10968809|NCT00903175|BG001|Baseline|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
11206937|NCT02239679|BG000|Baseline|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206938|NCT02239679|BG001|Baseline|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
10968810|NCT00903175|BG002|Baseline|Total|Total of all reporting groups
10968811|NCT00903175|FG000|Participant Flow|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
10968812|NCT00903175|FG001|Participant Flow|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
10968813|NCT00903175|OG000|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
10968814|NCT00903175|OG001|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
10968815|NCT00903175|EG000|Reported Event|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
10968816|NCT00903175|EG001|Reported Event|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
10968817|NCT00903201|BG000|Baseline|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
10968818|NCT00903201|BG001|Baseline|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
10968819|NCT00903201|BG002|Baseline|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
10968820|NCT00903201|BG003|Baseline|Total|Total of all reporting groups
10968821|NCT00903201|FG000|Participant Flow|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
11206939|NCT02239679|BG002|Baseline|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206940|NCT02239679|BG003|Baseline|Total|Total of all reporting groups
11206941|NCT02239679|FG000|Participant Flow|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening."
11206942|NCT02239679|FG001|Participant Flow|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206943|NCT02239679|FG002|Participant Flow|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206944|NCT02239679|OG000|Outcome|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206945|NCT02239679|OG001|Outcome|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206946|NCT02239679|OG002|Outcome|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206947|NCT02239679|EG000|Reported Event|ALA X2|"Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206948|NCT02239679|EG001|Reported Event|ALA X3|"Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments~Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206949|NCT02239679|EG002|Reported Event|VEH-PDT|"Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2~Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening."
11206950|NCT02239692|BG000|Baseline|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206951|NCT02239692|BG001|Baseline|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206952|NCT02239692|BG002|Baseline|Total|Total of all reporting groups
11206953|NCT02239692|FG000|Participant Flow|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206954|NCT02239692|FG001|Participant Flow|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206955|NCT02239692|OG000|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206956|NCT02239692|OG001|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206957|NCT02239692|EG000|Reported Event|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
11206958|NCT02239692|EG001|Reported Event|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
10822062|NCT00074282|FG001|Participant Flow|Arm B (Alemtuzumab: CR, nPR)|"Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients~Alemtuzumab"
11206959|NCT02239744|BG000|Baseline|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
11206960|NCT02239744|BG001|Baseline|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
11206961|NCT02239744|BG002|Baseline|Total|Total of all reporting groups
11206962|NCT02239744|FG000|Participant Flow|Sham Purifiers First, Then True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.
11206963|NCT02239744|FG001|Participant Flow|True Purifiers First, Then Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.
11206964|NCT02239744|OG000|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
11206965|NCT02239744|OG001|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
11206966|NCT02239744|OG000|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
11206967|NCT02239744|EG000|Reported Event|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
11206968|NCT02239744|EG001|Reported Event|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
11206969|NCT02239770|BG000|Baseline|0 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one placebo nicotine film.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206970|NCT02239770|BG001|Baseline|2 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 2 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206971|NCT02239770|BG002|Baseline|4 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 4 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206972|NCT02239770|BG003|Baseline|0, 0, 0, 0mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 0, 0, 0, 0 mg.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206973|NCT02239770|BG004|Baseline|2, 2, 2, 2mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206974|NCT02239770|BG005|Baseline|4, 4, 0, 4mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206975|NCT02239770|BG006|Baseline|Total|Total of all reporting groups
11206976|NCT02239770|FG000|Participant Flow|0 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one placebo nicotine film.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11286190|NCT02885025|OG001|Outcome|BSE + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
10968822|NCT00903201|FG001|Participant Flow|SB656933 20 mg|Eligible participants received SB656933 20 milligrams (mg) tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
11206977|NCT02239770|FG001|Participant Flow|2 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 2mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206978|NCT02239770|FG002|Participant Flow|4 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 4mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206979|NCT02239770|FG003|Participant Flow|0, 0, 0, 0mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 0, 0, 0, 0 mg.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206980|NCT02239770|FG004|Participant Flow|2, 2, 2, 2mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206981|NCT02239770|FG005|Participant Flow|4, 4, 0, 4mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206982|NCT02239770|OG000|Outcome|0 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one placebo nicotine film.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206983|NCT02239770|OG001|Outcome|2 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 2 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206984|NCT02239770|OG002|Outcome|4 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 4 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11244384|NCT02510664|EG000|Reported Event|Adolescent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
10818666|NCT00036738|BG000|Baseline|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
11206985|NCT02239770|OG003|Outcome|0, 0, 0, 0mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 0, 0, 0, 0 mg.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206986|NCT02239770|OG004|Outcome|2, 2, 2, 2mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206987|NCT02239770|OG005|Outcome|4, 4, 0, 4mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206988|NCT02239770|OG000|Outcome|0 mg Nicotine Film|"In Part 1, 4 participants will be allocated to this arm and receive one placebo nicotine film.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206989|NCT02239770|OG001|Outcome|2 mg Nicotine Film|"In Part 1, 4 participants will be allocated to this arm and receive one 2 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206990|NCT02239770|OG002|Outcome|4 mg Nicotine Film|"In Part 1, 4 participants will be allocated to this arm and receive one 4 mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206991|NCT02239770|OG003|Outcome|0, 0, 0, 0mg Nicotine Film Regimen|"In Part 2, 4 participants will be allocated to this arm and receive one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 0, 0, 0, 0 mg.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206992|NCT02239770|OG004|Outcome|2, 2, 2, 2mg Nicotine Film Regimen|"In Part 2, 4 participants will be allocated to this arm and receive one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206993|NCT02239770|OG005|Outcome|4, 4, 0, 4mg Nicotine Film Regimen|"In Part 2, 4 participants will be allocated to this arm and receive one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206994|NCT02239770|OG001|Outcome|2 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 2mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206995|NCT02239770|OG002|Outcome|4 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 4mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206996|NCT02239770|EG000|Reported Event|0 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one placebo nicotine film.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206997|NCT02239770|EG001|Reported Event|2 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 2mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206998|NCT02239770|EG002|Reported Event|4 mg Nicotine Film|"In Part 1, 4 participants were allocated to this arm and received one 4mg nicotine film.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11206999|NCT02239770|EG003|Reported Event|0, 0, 0, 0mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 0, 0, 0, 0 mg.~Placebo Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11207000|NCT02239770|EG004|Reported Event|2, 2, 2, 2mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 2, 2, 2, 2 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11207001|NCT02239770|EG005|Reported Event|4, 4, 0, 4mg Nicotine Film Regimen|"In Part 2, 4 participants were allocated to this arm and received one nicotine film every 3 hours (for a total of 4 films over 12 hours) in the following order: 4, 4, 0, 4 mg.~Nicotine Film: Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11207002|NCT02239939|BG000|Baseline|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11286191|NCT02885025|OG002|Outcome|Placebo Pill + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE."
11207003|NCT02239939|BG001|Baseline|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207004|NCT02239939|BG002|Baseline|Total|Total of all reporting groups
11207005|NCT02239939|FG000|Participant Flow|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207006|NCT02239939|FG001|Participant Flow|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207007|NCT02239939|OG000|Outcome|Diet+Vest|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207008|NCT02239939|OG001|Outcome|No Vest+Diet|"All participants will undergo a 22 week dietary weight loss.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207009|NCT02239939|OG000|Outcome|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207010|NCT02239939|OG001|Outcome|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207011|NCT02239939|EG000|Reported Event|Vest + Diet|"All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.~Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207012|NCT02239939|EG001|Reported Event|No Vest + Diet|"All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.~Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame."
11207013|NCT02239978|BG000|Baseline|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207014|NCT02239978|BG001|Baseline|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207015|NCT02239978|BG002|Baseline|Total|Total of all reporting groups
11207016|NCT02239978|FG000|Participant Flow|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207017|NCT02239978|FG001|Participant Flow|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207018|NCT02239978|OG000|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207019|NCT02239978|OG001|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207020|NCT02239978|OG002|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
11207021|NCT02239978|OG001|Outcome|Parkinson's Disease Off Medication|"These are the same participants as in the Parkinson's disease group, assessed Off their levodopa medication"
11207022|NCT02239978|EG000|Reported Event|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207023|NCT02239978|EG001|Reported Event|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
11207024|NCT02240030|BG000|Baseline|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207025|NCT02240030|BG001|Baseline|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207026|NCT02240030|BG002|Baseline|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
11207027|NCT02240030|BG003|Baseline|Total|Total of all reporting groups
11207028|NCT02240030|FG000|Participant Flow|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207029|NCT02240030|FG001|Participant Flow|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207030|NCT02240030|FG002|Participant Flow|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
11207031|NCT02240030|OG000|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
10968823|NCT00903201|FG002|Participant Flow|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
10968824|NCT00903201|OG000|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
10968825|NCT00903201|OG001|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
11207032|NCT02240030|OG001|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
11207033|NCT02240030|OG000|Outcome|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207034|NCT02240030|OG001|Outcome|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207035|NCT02240030|OG002|Outcome|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
11207036|NCT02240030|EG000|Reported Event|CVT-301 Low Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207037|NCT02240030|EG001|Reported Event|CVT-301 High Dose|"Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration~CVT-301"
11207038|NCT02240030|EG002|Reported Event|Placebo|"Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.~CVT-301"
11207039|NCT02240108|BG000|Baseline|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207040|NCT02240108|BG001|Baseline|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207041|NCT02240108|BG002|Baseline|Total|Total of all reporting groups
11207042|NCT02240108|FG000|Participant Flow|Rifaximin EIR 800 mg|Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
11207043|NCT02240108|FG001|Participant Flow|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207044|NCT02240108|OG000|Outcome|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207045|NCT02240108|OG001|Outcome|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207046|NCT02240108|EG000|Reported Event|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207047|NCT02240108|EG001|Reported Event|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207048|NCT02240121|BG000|Baseline|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207049|NCT02240121|BG001|Baseline|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207050|NCT02240121|BG002|Baseline|Total|Total of all reporting groups
11207051|NCT02240121|FG000|Participant Flow|Rifaximin EIR 800 mg|Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
11207052|NCT02240121|FG001|Participant Flow|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207053|NCT02240121|OG000|Outcome|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207054|NCT02240121|OG001|Outcome|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207055|NCT02240121|EG000|Reported Event|Rifaximin EIR 800 mg|Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
11207056|NCT02240121|EG001|Reported Event|Placebo|Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
11207057|NCT02240186|BG000|Baseline|Prosthetic Knee Joints|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207058|NCT02240186|FG000|Participant Flow|Prosthetic Knee Joints|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207059|NCT02240186|OG000|Outcome|Prosthetic Knee Joints|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207060|NCT02240186|OG000|Outcome|Prosthetic Knee Joints - NMPK Baseline|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207061|NCT02240186|OG001|Outcome|Prosthetic Knee Joint - MPK|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207062|NCT02240186|OG002|Outcome|Prosthetic Knee Joint - NMPK|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207063|NCT02240186|EG000|Reported Event|Prosthetic Knee Joints|"Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.~Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.~Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls."
11207064|NCT02240329|BG000|Baseline|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
11207065|NCT02240329|FG000|Participant Flow|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
11207066|NCT02240329|OG000|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
10847907|NCT00286728|BG000|Baseline|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
11207067|NCT02240329|EG000|Reported Event|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
11207068|NCT02240368|BG000|Baseline|Group 1|Children age between 1 month to 12 months
11207069|NCT02240368|BG001|Baseline|Group 2|Children age between 13 months and 36 months
11207070|NCT02240368|BG002|Baseline|Group 3|Children age between 37 months to 144 months
11207071|NCT02240368|BG003|Baseline|Total|Total of all reporting groups
11207072|NCT02240368|FG000|Participant Flow|Group 1|Children age between 1 month to 12 months
11207073|NCT02240368|FG001|Participant Flow|Group 2|Children age between 13 months and 36 months
11207074|NCT02240368|FG002|Participant Flow|Group 3|Children age between 37 months to 144 months
11207075|NCT02240368|OG000|Outcome|Group 1|Children age between 1 month to 12 months
11207076|NCT02240368|OG001|Outcome|Group 2|Children age between 13 months and 36 months
11207077|NCT02240368|OG002|Outcome|Group 3|Children age between 37 months to 144 months
11207078|NCT02240368|EG000|Reported Event|Group 1|Children age between 1 month to 12 months
11207079|NCT02240368|EG001|Reported Event|Group 2|Children age between 13 months and 36 months
11207080|NCT02240368|EG002|Reported Event|Group 3|Children age between 37 months to 144 months
11207081|NCT02240589|BG000|Baseline|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
11207082|NCT02240589|BG001|Baseline|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
11207083|NCT02240589|BG002|Baseline|Total|Total of all reporting groups
10847908|NCT00286728|BG001|Baseline|Arm 2 Usual Care|Usual care
10847909|NCT00286728|BG002|Baseline|Total|Total of all reporting groups
11207084|NCT02240589|FG000|Participant Flow|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
11207085|NCT02240589|FG001|Participant Flow|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
11207086|NCT02240589|OG000|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
11207087|NCT02240589|OG001|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
11207088|NCT02240589|EG000|Reported Event|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.~Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
11207089|NCT02240589|EG001|Reported Event|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.~Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
11207090|NCT02240628|BG000|Baseline|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
11207091|NCT02240628|BG001|Baseline|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
11207092|NCT02240628|BG002|Baseline|Total|Total of all reporting groups
11207093|NCT02240628|FG000|Participant Flow|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
11207094|NCT02240628|FG001|Participant Flow|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
11207095|NCT02240628|OG000|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
11207096|NCT02240628|OG001|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
11207097|NCT02240628|EG000|Reported Event|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
11207098|NCT02240628|EG001|Reported Event|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
11207099|NCT02240654|BG000|Baseline|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207100|NCT02240654|BG001|Baseline|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207101|NCT02240654|BG002|Baseline|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
11207102|NCT02240654|BG003|Baseline|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
11207103|NCT02240654|BG004|Baseline|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
11207104|NCT02240654|BG005|Baseline|Total|Total of all reporting groups
11207105|NCT02240654|FG000|Participant Flow|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207106|NCT02240654|FG001|Participant Flow|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207107|NCT02240654|FG002|Participant Flow|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
11207108|NCT02240654|FG003|Participant Flow|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
11207109|NCT02240654|FG004|Participant Flow|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
11207110|NCT02240654|OG000|Outcome|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207111|NCT02240654|OG001|Outcome|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207112|NCT02240654|OG002|Outcome|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
11207113|NCT02240654|OG003|Outcome|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
11207114|NCT02240654|OG004|Outcome|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
11207115|NCT02240654|EG000|Reported Event|Dabigatran Etexilate (Pradaxa®)_France (Cardiologists)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of cardiologists in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207116|NCT02240654|EG001|Reported Event|Dabigatran Etexilate (Pradaxa®)_France (GPs)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) identified from panels of general practitioners (GPs) in Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD) in France (primary care information)
11207117|NCT02240654|EG002|Reported Event|Dabigatran Etexilate (Pradaxa®)_Denmark|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in National Health Databases in Denmark (DK) (hospital episodes, dispensed ambulatory medications)
11207118|NCT02240654|EG003|Reported Event|Dabigatran Etexilate (Pradaxa®)_UK (HES Linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) Hospital Episode Statistics (HES) linkable (primary care information, hospital episodes, dispensed ambulatory medications)
11207119|NCT02240654|EG004|Reported Event|Dabigatran Etexilate (Pradaxa®)_UK (HES Non-linkable)|New users of Dabigatran etexilate (Pradaxa capsules, 75 mg, 110 mg and 150 mg) in Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK) non-linkable HES (primary care information)
11207120|NCT02240667|BG000|Baseline|Dabigatran (Dabigatran vs VKA)|Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.
11207121|NCT02240667|BG001|Baseline|Vitamin K Antagonists (VKA)|Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.
11207122|NCT02240667|BG002|Baseline|Total|Total of all reporting groups
11207123|NCT02240667|FG000|Participant Flow|Dabigatran (Dabigatran vs VKA)|Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.
11207124|NCT02240667|FG001|Participant Flow|Vitamin K Antagonists (VKA)|Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.
11207125|NCT02240667|OG000|Outcome|Dabigatran (Dabigatran vs VKA)|Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).
11207126|NCT02240667|OG001|Outcome|VKA (Dabigatran vs VKA)|Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).
11207127|NCT02240667|EG000|Reported Event|Dabigatran (Dabigatran vs VKA)|Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.
11207128|NCT02240667|EG001|Reported Event|Vitamin K Antagonists (VKA)|Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.
11207129|NCT02240680|BG000|Baseline|Placebo (Up to 24 Weeks)|Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks
11207130|NCT02240680|BG001|Baseline|Linagliptin 5 Milligram (Up to 24 Weeks)|Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
11207131|NCT02240680|BG002|Baseline|Total|Total of all reporting groups
11207132|NCT02240680|FG000|Participant Flow|Placebo (Up to 24 Weeks)|Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks
10968826|NCT00903201|OG002|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
11207133|NCT02240680|FG001|Participant Flow|Linagliptin 5 Milligram (Up to 24 Weeks)|Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
11207134|NCT02240680|FG002|Participant Flow|Placebo (Up to 52 Weeks)|Only Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks
11207135|NCT02240680|FG003|Participant Flow|Linagliptin 5 Milligram (Up to 52 Weeks)|Only Japanese patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 52 weeks
11207136|NCT02240680|OG000|Outcome|Placebo (Up to 24 Weeks)|Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks
11207137|NCT02240680|OG001|Outcome|Linagliptin 5 Milligram (Up to 24 Weeks)|Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
10968827|NCT00903201|OG000|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
11207138|NCT02240680|EG000|Reported Event|Placebo (Up to 24 Weeks)|Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks
11207139|NCT02240680|EG001|Reported Event|Linagliptin 5 mg (Up to 24 Weeks)|Patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 24 weeks.
11207140|NCT02240680|EG002|Reported Event|Placebo (Up to 52 Weeks)|Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks
11207141|NCT02240680|EG003|Reported Event|Linagliptin 5mg (Up to 52 Weeks)|Japanese patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 52 weeks.
11207142|NCT02240693|BG000|Baseline|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
11207143|NCT02240693|BG001|Baseline|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11207144|NCT02240693|BG002|Baseline|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11207145|NCT02240693|BG003|Baseline|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11207146|NCT02240693|BG004|Baseline|Placebo Matching BI 409306|Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
11207147|NCT02240693|BG005|Baseline|Total|Total of all reporting groups
11207148|NCT02240693|FG000|Participant Flow|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
11207149|NCT02240693|FG001|Participant Flow|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11207150|NCT02240693|FG002|Participant Flow|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11207151|NCT02240693|FG003|Participant Flow|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11207152|NCT02240693|FG004|Participant Flow|Placebo Matching BI 409306|Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
11207153|NCT02240693|OG000|Outcome|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
11207154|NCT02240693|OG001|Outcome|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11207155|NCT02240693|OG002|Outcome|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11207156|NCT02240693|OG003|Outcome|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11207157|NCT02240693|OG004|Outcome|Pooled BI 409306|Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
11207158|NCT02240693|OG005|Outcome|Placebo Matching BI 409306|Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
11207159|NCT02240693|OG004|Outcome|Placebo Matching BI 409306|Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
11207160|NCT02240693|EG000|Reported Event|BI 409306 10 Milligram (mg) Once Daily (QD)|Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
11207161|NCT02240693|EG001|Reported Event|BI 409306 25 mg QD|Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
11207162|NCT02240693|EG002|Reported Event|BI 409306 50 mg QD|Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
11207163|NCT02240693|EG003|Reported Event|BI 409306 25 mg Twice Daily (BID)|Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
11207164|NCT02240693|EG004|Reported Event|Placebo Matching BI 409306|Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
11207165|NCT02240706|BG000|Baseline|BI 836858 20 mg (Phase I)|All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207166|NCT02240706|BG001|Baseline|BI 836858 40 mg (Phase I)|All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207167|NCT02240706|BG002|Baseline|BI 836858 80 mg (Phase I)|All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207168|NCT02240706|BG003|Baseline|BI 836858 160 mg (Phase I)|All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207169|NCT02240706|BG004|Baseline|BI 836858 320 mg (Phase I)|All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207170|NCT02240706|BG005|Baseline|Total|Total of all reporting groups
11207171|NCT02240706|FG000|Participant Flow|BI 836858 20 mg (Phase I)|All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207172|NCT02240706|FG001|Participant Flow|BI 836858 40 mg (Phase I)|All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207173|NCT02240706|FG002|Participant Flow|BI 836858 80 mg (Phase I)|All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207174|NCT02240706|FG003|Participant Flow|BI 836858 160 mg (Phase I)|All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207175|NCT02240706|FG004|Participant Flow|BI 836858 320 mg (Phase I)|All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207176|NCT02240706|FG005|Participant Flow|BI 836858 + Best Supportive Care (BSC) (Phase II)|All patients were planned to be administered doses of BI 836858, recommended phase 2 dose (RP2D) together with best supportive care (BSC) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207177|NCT02240706|FG006|Participant Flow|Best Supportive Care (BSC) Only (Phase II)|All patients were planned to be administered best supportive care (BSC) including red blood cell transfusion, platelet transfusion and iron chelation therapy.
11207178|NCT02240706|OG000|Outcome|BI 836858|"Treatment group BI 836858 comprises all dose cohorts during the dose escalation phase, that is, BI 836858 20 mg, BI 836858 40 mg, BI 836858 80 mg, BI 836858 160 mg and BI 836858 320 mg.~All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient."
11207179|NCT02240706|OG000|Outcome|BI 836858 20 mg (Phase I)|All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
10968828|NCT00903201|OG001|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
11207180|NCT02240706|OG001|Outcome|BI 836858 40 mg (Phase I)|All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207181|NCT02240706|OG002|Outcome|BI 836858 80 mg (Phase I)|All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207182|NCT02240706|OG003|Outcome|BI 836858 160 mg (Phase I)|All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207183|NCT02240706|OG004|Outcome|BI 836858 320 mg (Phase I)|All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207184|NCT02240706|OG000|Outcome|BI 836858 + Best Supportive Care (BSC) (Phase II)|All patients were planned to be administered doses of BI 836858, recommended phase 2 dose (RP2D) together with best supportive care (BSC) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207185|NCT02240706|OG001|Outcome|Best Supportive Care (BSC) Only (Phase II)|All patients were planned to be administered best supportive care (BSC) including red blood cell transfusion, platelet transfusion and iron chelation therapy.
11207186|NCT02240706|EG000|Reported Event|BI 836858 20mg|All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207187|NCT02240706|EG001|Reported Event|BI 836858 40mg|All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207188|NCT02240706|EG002|Reported Event|BI 836858 80mg|All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207189|NCT02240706|EG003|Reported Event|BI 836858 160mg|All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207190|NCT02240706|EG004|Reported Event|BI 836858 320mg|All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
11207191|NCT02240810|BG000|Baseline|PLATINUM Diversity (Overall)|"Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.~Overall population."
11207192|NCT02240810|BG001|Baseline|PROMUS Element Plus US Post Approval Study (Overall)|"PROMUS Element Plus US Post Approval Study~NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978"
10968829|NCT00903201|EG000|Reported Event|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
11207193|NCT02240810|BG002|Baseline|Total|Total of all reporting groups
11207194|NCT02240810|FG000|Participant Flow|PLATINUM Diversity (Overall)|"Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.~Overall population."
11207195|NCT02240810|FG001|Participant Flow|PROMUS Element Plus US Post Approval Study|PROMUS Element Plus US Post Approval Study
11207196|NCT02240810|OG000|Outcome|PLATINUM Diversity (Overall)|"Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.~Overall population."
11207197|NCT02240810|OG001|Outcome|Caucasian Males - PROMUS Element Plus US Post Approval Study|Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study
11207198|NCT02240810|OG002|Outcome|Females - PLATINUM Diversity and PE+|All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
11207199|NCT02240810|OG003|Outcome|Minorities - PLATINUM Diversity and PE+|All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
11207200|NCT02240810|EG000|Reported Event|PLATINUM Diversity (Overall)|"Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.~Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978."
11207201|NCT02241486|BG000|Baseline|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
10968830|NCT00903201|EG001|Reported Event|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
10968831|NCT00903201|EG002|Reported Event|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
10968832|NCT00903331|BG000|Baseline|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
10968833|NCT00903331|BG001|Baseline|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
10968834|NCT00903331|BG002|Baseline|Total|Total of all reporting groups
10968835|NCT00903331|FG000|Participant Flow|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
10968836|NCT00903331|FG001|Participant Flow|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
10968837|NCT00903331|OG000|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
10968838|NCT00903331|OG001|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
10968839|NCT00903331|EG000|Reported Event|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
10968840|NCT00903331|EG001|Reported Event|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
10968841|NCT00903344|BG000|Baseline|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
10968842|NCT00903344|BG001|Baseline|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
10968843|NCT00903344|BG002|Baseline|Total|Total of all reporting groups
10968844|NCT00903344|FG000|Participant Flow|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
10968845|NCT00903344|FG001|Participant Flow|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
10968846|NCT00903344|OG000|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
10968847|NCT00903344|OG001|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
10968848|NCT00903344|EG000|Reported Event|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
10968849|NCT00903344|EG001|Reported Event|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
10968850|NCT00903357|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Montelukast first and placebo first.
10968851|NCT00903357|FG000|Participant Flow|Montelukast First, Then Placebo|Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).
10968852|NCT00903357|FG001|Participant Flow|Placebo First, Then Montelukast|Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
10968853|NCT00903357|OG000|Outcome|Montelukast Sodium|Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968854|NCT00903357|OG001|Outcome|Placebo Drug|Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968855|NCT00903357|OG000|Outcome|Montelukast Sodium|Changes of Urine LTE4 after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968856|NCT00903357|OG001|Outcome|Placebo Drug|Changes of Urine LTE4 after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968857|NCT00903357|OG000|Outcome|Montelukast Sodium|Changes of Urine EDN after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968858|NCT00903357|OG001|Outcome|Placebo Drug|Changes of Urine EDN after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
10968859|NCT00903357|EG000|Reported Event|Montelukast Sodium|Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period.
11207202|NCT02241486|FG000|Participant Flow|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
10818667|NCT00036738|FG000|Participant Flow|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
10818668|NCT00036738|OG000|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
10818669|NCT00036738|EG000|Reported Event|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
11207203|NCT02241486|OG000|Outcome|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
11207204|NCT02241486|EG000|Reported Event|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
11207205|NCT02241512|BG000|Baseline|Ibuprofen|"Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).~Ibuprofen"
11207206|NCT02241512|BG001|Baseline|Placebo|"Single dose IV normal saline~placebo"
11207207|NCT02241512|BG002|Baseline|Total|Total of all reporting groups
11207208|NCT02241512|FG000|Participant Flow|Ibuprofen|"Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).~Ibuprofen"
11207209|NCT02241512|FG001|Participant Flow|Placebo|"Single dose IV normal saline~placebo"
11207210|NCT02241512|OG000|Outcome|Ibuprofen|"Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).~Ibuprofen"
11207211|NCT02241512|OG001|Outcome|Placebo|"Single dose IV normal saline~placebo"
11207212|NCT02241512|EG000|Reported Event|Ibuprofen|"Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).~Ibuprofen"
11207213|NCT02241512|EG001|Reported Event|Placebo|"Single dose IV normal saline~placebo"
11207214|NCT02241655|BG000|Baseline|EEG Guided Protocol|"Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.~a pragmatic EEG-guided anesthetic protocol"
11207215|NCT02241655|BG001|Baseline|Control Arm|Participants will have the standard anesthetic protocol.
11207216|NCT02241655|BG002|Baseline|Total|Total of all reporting groups
11207217|NCT02241655|FG000|Participant Flow|EEG Guided Protocol|"Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.~a pragmatic EEG-guided anesthetic protocol"
11207218|NCT02241655|FG001|Participant Flow|Control Arm|Participants will have the standard anesthetic protocol.
11207219|NCT02241655|OG000|Outcome|EEG Guided Protocol|"Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.~a pragmatic EEG-guided anesthetic protocol"
11207220|NCT02241655|OG001|Outcome|Control Arm|Participants will have the standard anesthetic protocol.
11207221|NCT02241655|OG000|Outcome|No Delirium|intact with no delirium throughout postoperative days (POD) 0-5
11207222|NCT02241655|OG001|Outcome|Delirium POD 0-1|Patients who were delirious POD 0-1
11207223|NCT02241655|OG002|Outcome|Delirium POD 2-5|Patients who were delirious POD 2-5
11207224|NCT02241655|OG000|Outcome|Patients With Nursing ICU Assessment|Patients who were in the ICU and had a nursing CAM-ICU and researcher's delirium assessment were included in this analysis.
11207225|NCT02241655|OG000|Outcome|Regression Analysis|The purpose of the logistic regression and adjustment for prognostic covariates was to improve the power of the trial to detect a beneficial effect attributable to the intervention (minimization of electroencephalographic suppression) or to usual anesthesia care on the outcome of interest, postoperative delirium.
11207226|NCT02241655|EG000|Reported Event|EEG Guided Protocol|"Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.~a pragmatic EEG-guided anesthetic protocol"
11207227|NCT02241655|EG001|Reported Event|Control Arm|Participants will have the standard anesthetic protocol.
11207228|NCT02241720|BG000|Baseline|Regorafenib Treatment|regorafenib
11207229|NCT02241720|FG000|Participant Flow|Regorafenib Treatment|160 mg regorafenib by mouth once daily for 3 weeks of every 4 week cycle
11207230|NCT02241720|OG000|Outcome|Regorafenib Treatment|regorafenib
11207231|NCT02241720|EG000|Reported Event|Regorafenib Treatment|regorafenib
11207232|NCT02241733|BG000|Baseline|Exercise|"Patients will exercise for 12 weeks and then participate in an adherence program~Exercise only: Patients will participate in a 12-week exercise program . They will also participate in an adherence program."
11207233|NCT02241733|BG001|Baseline|Exercise Plus Breathing Retraining|"Patients will exercise plus breathing retraining for 12 weeks and then participate in an adherence program~Breathing retraining plus exercise: Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program."
11207234|NCT02241733|BG002|Baseline|Total|Total of all reporting groups
11207235|NCT02241733|FG000|Participant Flow|Exercise|"Patients exercised for 12 weeks and then participated in an adherence program~Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program."
11207236|NCT02241733|FG001|Participant Flow|Exercise Plus Breathing Retraining|"Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program~Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program."
11207237|NCT02241733|OG000|Outcome|Exercise|"Patients exercised for 12 weeks and then participated in an adherence program~Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program."
11207238|NCT02241733|OG001|Outcome|Exercise Plus Breathing Retraining|"Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program~Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program."
11207239|NCT02241733|EG000|Reported Event|Exercise|"Patients exercised for 12 weeks and then participated in an adherence program~Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program."
11207240|NCT02241733|EG001|Reported Event|Exercise Plus Breathing Retraining|"Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program~Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program."
11215465|NCT02299388|BG000|Baseline|Liraglutide|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215466|NCT02299388|BG001|Baseline|Placebo|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215467|NCT02299388|BG002|Baseline|Total|Total of all reporting groups
11215468|NCT02299388|FG000|Participant Flow|Liraglutide|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215469|NCT02299388|FG001|Participant Flow|Placebo|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215470|NCT02299388|OG000|Outcome|Liraglutide|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11286192|NCT02885025|OG003|Outcome|Placebo Pill + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
10818670|NCT00037830|BG000|Baseline|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
10818671|NCT00037830|BG001|Baseline|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
10968860|NCT00903357|EG001|Reported Event|Placebo Drug|Placebo drug administered once daily in either first intervention period or second intervention period.
10968861|NCT00903370|BG000|Baseline|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
10968862|NCT00903370|BG001|Baseline|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
10968863|NCT00903370|BG002|Baseline|Total|Total of all reporting groups
10968864|NCT00903370|FG000|Participant Flow|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
10968865|NCT00903370|FG001|Participant Flow|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
10968866|NCT00903370|OG000|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
10968867|NCT00903370|OG001|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
10968868|NCT00903370|EG000|Reported Event|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
10968869|NCT00903370|EG001|Reported Event|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
10968870|NCT00903383|BG000|Baseline|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
11207241|NCT02241785|BG000|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks
10818672|NCT00037830|BG002|Baseline|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
10968871|NCT00903383|BG001|Baseline|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
10968872|NCT00903383|BG002|Baseline|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
10968873|NCT00903383|BG003|Baseline|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
10968874|NCT00903383|BG004|Baseline|Total|Total of all reporting groups
11207242|NCT02241785|FG000|Participant Flow|Natalizumab|natalizumab 300 mg intravenously (IV) every 4 weeks
11207243|NCT02241785|OG000|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
11207244|NCT02241785|EG000|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks
10818673|NCT00037830|BG003|Baseline|Total|Total of all reporting groups
10818674|NCT00037830|FG000|Participant Flow|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
10818675|NCT00037830|FG001|Participant Flow|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
10818676|NCT00037830|FG002|Participant Flow|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
11207245|NCT02241889|BG000|Baseline|All Study Participants|All study participants underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. Treatment order was randomized.
11207246|NCT02241889|FG000|Participant Flow|SAP, APN, APX (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
11207247|NCT02241889|FG001|Participant Flow|SAP, APX, APN (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
11207248|NCT02241889|FG002|Participant Flow|APN, SAP and APX (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
11207249|NCT02241889|FG003|Participant Flow|APN, APX, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
11207250|NCT02241889|FG004|Participant Flow|APX, SAP, APN (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
11207251|NCT02241889|FG005|Participant Flow|APX, APN, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
11207252|NCT02241889|OG000|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
10818677|NCT00037830|OG000|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
10818678|NCT00037830|OG001|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
10818679|NCT00037830|OG000|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
10818680|NCT00037830|EG000|Reported Event|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
10818681|NCT00037830|EG001|Reported Event|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
10818682|NCT00037830|EG002|Reported Event|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
10818683|NCT00038103|BG000|Baseline|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
10818684|NCT00038103|BG001|Baseline|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
10818685|NCT00038103|BG002|Baseline|Total|Total of all reporting groups
10818686|NCT00038103|FG000|Participant Flow|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
10818687|NCT00038103|FG001|Participant Flow|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
10818688|NCT00038103|OG000|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
10818689|NCT00038103|OG001|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
10818690|NCT00038103|EG000|Reported Event|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
10818691|NCT00038103|EG001|Reported Event|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
10818692|NCT00038467|BG000|Baseline|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
10968875|NCT00903383|FG000|Participant Flow|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
11207253|NCT02241889|OG001|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
11207254|NCT02241889|OG002|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
11207255|NCT02241889|EG000|Reported Event|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
11207256|NCT02241889|EG001|Reported Event|Closed-loop Without Adjustment|"Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
11207257|NCT02241889|EG002|Reported Event|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
11207258|NCT02241967|BG000|Baseline|tDCS Full Dose|"4 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207259|NCT02241967|BG001|Baseline|tDCS Half Dose|"2 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207260|NCT02241967|BG002|Baseline|tDCS Minimal Dose|"1 active treatment~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207261|NCT02241967|BG003|Baseline|Sham tDCS|"no active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207262|NCT02241967|BG004|Baseline|Total|Total of all reporting groups
11207263|NCT02241967|FG000|Participant Flow|tDCS Full Dose|"4 active treatments administered at 2mA for 20minutes each sessions, two the day of surgery and two the day after surgery.~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207264|NCT02241967|FG001|Participant Flow|tDCS Half Dose|"2 active treatments administered at 2mA for 20minutes each sessions. 2 real sessions the day of surgery and 2 sham sessions the day after surgery.~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207265|NCT02241967|FG002|Participant Flow|tDCS Minimal Dose|"1 active treatment administered at 2mA for 20minutes for the first session immediately following surgery, then 1 sham session later, day of surgery, and 2 sham sessions the day after surgery.~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207266|NCT02241967|FG003|Participant Flow|Sham tDCS|"no active treatments. All 4 sessions were sham tDCS. 2 delivered day of surgery, 2 delivered day after surgery.~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
10818693|NCT00038467|BG001|Baseline|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
10818694|NCT00038467|BG002|Baseline|Total|Total of all reporting groups
10818695|NCT00038467|FG000|Participant Flow|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
10818696|NCT00038467|FG001|Participant Flow|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
11207267|NCT02241967|OG000|Outcome|tDCS Full Dose|"4 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
10818697|NCT00038467|OG000|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
11207268|NCT02241967|OG001|Outcome|tDCS Half Dose|"2 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207269|NCT02241967|OG002|Outcome|tDCS Minimal Dose|"1 active treatment~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207270|NCT02241967|OG003|Outcome|Sham tDCS|"no active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207271|NCT02241967|EG000|Reported Event|tDCS Full Dose|"4 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207272|NCT02241967|EG001|Reported Event|tDCS Half Dose|"2 active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207273|NCT02241967|EG002|Reported Event|tDCS Minimal Dose|"1 active treatment~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207274|NCT02241967|EG003|Reported Event|Sham tDCS|"no active treatments~Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp."
11207275|NCT02242019|BG000|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11207276|NCT02242019|FG000|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11207277|NCT02242019|OG000|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11207278|NCT02242019|EG000|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11207279|NCT02242045|BG000|Baseline|Idelalisib|Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
11207280|NCT02242045|FG000|Participant Flow|Idelalisib|Participants with indolent non-hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL) received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
11207281|NCT02242045|OG000|Outcome|Idelalisib|Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
11207282|NCT02242045|EG000|Reported Event|Idelalisib|Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
11207283|NCT02242201|BG000|Baseline|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
11207284|NCT02242201|BG001|Baseline|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207285|NCT02242201|BG002|Baseline|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207286|NCT02242201|BG003|Baseline|Total|Total of all reporting groups
11207287|NCT02242201|FG000|Participant Flow|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~Posterior lumbar plexus block (PNB) Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
11207288|NCT02242201|FG001|Participant Flow|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~Periarticular infiltration (PAI) Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207289|NCT02242201|FG002|Participant Flow|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207290|NCT02242201|OG000|Outcome|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
11207291|NCT02242201|OG001|Outcome|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207292|NCT02242201|OG002|Outcome|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207293|NCT02242201|EG000|Reported Event|PNB Bupivacaine|"Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.~PNB Bupivacaine: Infusion~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg"
11207294|NCT02242201|EG001|Reported Event|PAI Ropivacaine|"Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.~PAI Ropivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207295|NCT02242201|EG002|Reported Event|PAI Liposomal Bupivacaine|"Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.~PAI liposomal bupivacaine: Injection~Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg~Ketorolac: Injection, 30 mg"
11207296|NCT02242305|BG000|Baseline|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
11207297|NCT02242305|BG001|Baseline|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
11207298|NCT02242305|BG002|Baseline|Total|Total of all reporting groups
11207299|NCT02242305|FG000|Participant Flow|Hyoscine Butylbromide - Tablet (Tab.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
11207300|NCT02242305|FG001|Participant Flow|Hyoscine Butylbromide - Capsule (Cap.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
11207301|NCT02242305|OG000|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
11207302|NCT02242305|OG001|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
11207303|NCT02242305|EG000|Reported Event|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
11207304|NCT02242305|EG001|Reported Event|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
11207305|NCT02242487|BG000|Baseline|CVT-301 Low Dose|"60 mg (two capsules of 30 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration~CVT-301"
11207306|NCT02242487|BG001|Baseline|CVT-301 High Dose|"84 mg (two capsules of 42 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration~CVT-301"
11207307|NCT02242487|BG002|Baseline|Total|Total of all reporting groups
11207308|NCT02242487|FG000|Participant Flow|CVT-301 Low Dose|"Two capsules of 30 mg each (60 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration~CVT-301"
11207309|NCT02242487|FG001|Participant Flow|CVT-301 High Dose|"Two capsules of 42 mg each (84 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration~CVT-301"
11207310|NCT02242487|OG000|Outcome|CVT-301 DL1|60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
11207311|NCT02242487|OG001|Outcome|CVT-301 DL2|84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
11207312|NCT02242487|OG000|Outcome|CVT-301 DL1|60 mg (two capsules of 30 mg each) of Levodopa Inhalation Powder (LIP)
11207313|NCT02242487|OG001|Outcome|CVT-301 DL2|84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP)
11207314|NCT02242487|EG000|Reported Event|CVT-301 Low Dose|60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
11207315|NCT02242487|EG001|Reported Event|CVT-301 HIgh Dose|84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
11207316|NCT02242630|BG000|Baseline|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207317|NCT02242630|BG001|Baseline|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207318|NCT02242630|BG002|Baseline|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207319|NCT02242630|BG003|Baseline|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
11207320|NCT02242630|BG004|Baseline|Total|Total of all reporting groups
11207321|NCT02242630|FG000|Participant Flow|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
10847910|NCT00286728|FG000|Participant Flow|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
11207322|NCT02242630|FG001|Participant Flow|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207323|NCT02242630|FG002|Participant Flow|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207324|NCT02242630|FG003|Participant Flow|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
11207325|NCT02242630|OG000|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207326|NCT02242630|OG001|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207327|NCT02242630|OG002|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207328|NCT02242630|OG003|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
11207329|NCT02242630|EG000|Reported Event|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207330|NCT02242630|EG001|Reported Event|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207331|NCT02242630|EG002|Reported Event|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
11207332|NCT02242630|EG003|Reported Event|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
11207333|NCT02242643|BG000|Baseline|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207334|NCT02242643|BG001|Baseline|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207335|NCT02242643|BG002|Baseline|Total|Total of all reporting groups
11207336|NCT02242643|FG000|Participant Flow|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
10818698|NCT00038467|OG001|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
10818699|NCT00038467|EG000|Reported Event|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
11207337|NCT02242643|FG001|Participant Flow|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207338|NCT02242643|OG000|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207339|NCT02242643|OG001|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207340|NCT02242643|OG000|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
11207341|NCT02242643|OG001|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
11207342|NCT02242643|EG000|Reported Event|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207343|NCT02242643|EG001|Reported Event|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
11207344|NCT02242903|BG000|Baseline|Placebo|Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
11207345|NCT02242903|BG001|Baseline|LY3079514 (LY) Cohort 1|7 mg single dose of LY3079514 administered by SC injection during a single occasion
11207346|NCT02242903|BG002|Baseline|LY Cohort 2|21 mg single dose of LY3079514 administered by SC injection during a single occasion
11207347|NCT02242903|BG003|Baseline|LY Cohort 3|70 mg single dose of LY3079514 administered by SC during a single occasion
11207348|NCT02242903|BG004|Baseline|LY Cohort 4|210 mg single dose of LY3079514 administered by SC during a single occasion
11207349|NCT02242903|BG005|Baseline|LY Cohort 5|70 mg single dose of LY3079514 administered IV during a single occasion
11207350|NCT02242903|BG006|Baseline|LY Cohort 6|210 mg single dose of LY3079514 administered IV during a single occasion
11207351|NCT02242903|BG007|Baseline|Total|Total of all reporting groups
11207352|NCT02242903|FG000|Participant Flow|Placebo|Single dose of placebo matching LY3079514 administered intravenous (IV) infusion or subcutaneous (SC) injection during a single occasion.
10818700|NCT00038467|EG001|Reported Event|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
10818701|NCT00038610|BG000|Baseline|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
10818702|NCT00038610|FG000|Participant Flow|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
10818703|NCT00038610|OG000|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
10818704|NCT00038610|EG000|Reported Event|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
10818705|NCT00038649|BG000|Baseline|Gleevec|Gleevec 400 mg orally twice daily.
10818706|NCT00038649|FG000|Participant Flow|Gleevec|Gleevec 400 mg orally twice daily.
10818707|NCT00038649|OG000|Outcome|Gleevec|Gleevec 400 mg orally twice daily.
10818708|NCT00038649|EG000|Reported Event|Gleevec|Gleevec 400 mg orally twice daily.
10818709|NCT00038857|BG000|Baseline|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
10818710|NCT00038857|FG000|Participant Flow|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
10818711|NCT00038857|OG000|Outcome|Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC|Melphalan 140 mg/m^2 given for one day. Thiotepa 10 mg/kg given for one day. Fludarabine 40 mg/m^2 given daily for four days. Rabbit ATG 1.5 mg/kg given daily for four days. Infusion of CD34+ Selected Cells given on Day 0.
10818712|NCT00038857|EG000|Reported Event|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
10818713|NCT00038948|BG000|Baseline|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
10818714|NCT00038948|BG001|Baseline|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
11207353|NCT02242903|FG001|Participant Flow|LY3079514 Cohort 1|7 milligrams (mg) single dose of LY3079514 administered by SC injection during a single occasion.
10818715|NCT00038948|BG002|Baseline|Total|Total of all reporting groups
10818716|NCT00038948|FG000|Participant Flow|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
10818717|NCT00038948|FG001|Participant Flow|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
10847911|NCT00286728|FG001|Participant Flow|Arm 2 Usual Care|Usual care
11207354|NCT02242903|FG002|Participant Flow|LY3079514 Cohort 2|21 mg single dose of LY3079514 administered by SC injection during a single occasion.
11207355|NCT02242903|FG003|Participant Flow|LY3079514 Cohort 3|70 mg single dose of LY3079514 administered by SC injection during a single occasion.
11207356|NCT02242903|FG004|Participant Flow|LY3079514 Cohort 4|210 mg single dose of LY3079514 administered by SC injection during a single occasion.
11207357|NCT02242903|FG005|Participant Flow|LY3079514 Cohort 5|70 mg single dose of LY3079514 administered IV during a single occasion.
10818718|NCT00038948|OG000|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
10818719|NCT00038948|OG001|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
10818720|NCT00038948|OG002|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
10818721|NCT00038948|OG003|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
10818722|NCT00038948|OG000|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
10818723|NCT00038948|OG001|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor therapy
10818724|NCT00038948|OG002|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
10818725|NCT00038948|OG003|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor therapy
10818726|NCT00038948|EG000|Reported Event|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
10818727|NCT00038948|EG001|Reported Event|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
10818728|NCT00039130|BG000|Baseline|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
10818729|NCT00039130|FG000|Participant Flow|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
10818730|NCT00039130|OG000|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
10818731|NCT00039130|EG000|Reported Event|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
10818732|NCT00039195|BG000|Baseline|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
11207358|NCT02242903|FG006|Participant Flow|LY3079514 Cohort 6|210 mg single dose of LY3079514 administered IV during a single occasion.
11207359|NCT02242903|OG000|Outcome|Placebo|Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion
11207360|NCT02242903|OG001|Outcome|LY3079514 (LY) Cohort 1|7 mg single dose of LY3079514 administered by SC injection during a single occasion
11207361|NCT02242903|OG002|Outcome|LY Cohort 2|21 mg single dose of LY3079514 administered by SC injection during a single occasion
10818733|NCT00039195|FG000|Participant Flow|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
10818734|NCT00039195|OG000|Outcome|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
10818735|NCT00039195|EG000|Reported Event|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
11207362|NCT02242903|OG003|Outcome|LY Cohort 3|70 mg single dose of LY3079514 administered by SC during a single occasion
11207363|NCT02242903|OG004|Outcome|LY Cohort 4|210 mg single dose of LY3079514 administered by SC during a single occasion
11207364|NCT02242903|OG005|Outcome|LY Cohort 5|70 mg single dose of LY3079514 administered IV during a single occasion
11207365|NCT02242903|OG006|Outcome|LY Cohort 6|210 mg single dose of LY3079514 administered IV during a single occasion
11207366|NCT02242903|OG000|Outcome|LY Cohort 1|7 mg single dose of LY3079514 administered by SC injection during a single occasion
11207367|NCT02242903|OG001|Outcome|LY Cohort 2|21 mg single dose of LY3079514 administered by SC injection during a single occasion
11207368|NCT02242903|OG002|Outcome|LY Cohort 3|70 mg single dose of LY3079514 administered by SC injection during a single occasion
10818736|NCT00039377|BG000|Baseline|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
10818737|NCT00039377|FG000|Participant Flow|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
10818738|NCT00039377|FG001|Participant Flow|Patients With HLA-matched Sibling Donor in Course 5|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818739|NCT00039377|FG002|Participant Flow|Patients Without HLA-matched Sibling Donors in Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818740|NCT00039377|FG003|Participant Flow|Patients Who Did Not Undergo Transplant for Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
11207369|NCT02242903|OG003|Outcome|LY Cohort 4|210 mg single dose of LY3079514 administered by SC injection during a single occasion
10818741|NCT00039377|OG000|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
11207370|NCT02242903|OG004|Outcome|LY Cohort 5|70 mg single dose of LY3079514 administered IV during a single occasion
11207371|NCT02242903|OG005|Outcome|LY Cohort 6|210 mg single dose of LY3079514 administered IV during a single occasion
11207372|NCT02242903|EG000|Reported Event|Placebo|Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
10818742|NCT00039377|OG000|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10847912|NCT00286728|OG000|Outcome|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
10847913|NCT00286728|OG001|Outcome|Arm 2 Usual Care|Usual care
10968876|NCT00903383|FG001|Participant Flow|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
11207373|NCT02242903|EG001|Reported Event|LY3079514 (LY) Cohort 1|7 mg single dose of LY3079514 administered by SC injection during a single occasion
11207374|NCT02242903|EG002|Reported Event|LY Cohort 2|21 mg single dose of LY3079514 administered by SC injection during a single occasion
11207375|NCT02242903|EG003|Reported Event|LY Cohort 3|70 mg single dose of LY3079514 administered by SC injection during a single occasion
11207376|NCT02242903|EG004|Reported Event|LY Cohort 4|210 mg single dose of LY3079514 administered by SC injection during a single occasion
11207377|NCT02242903|EG005|Reported Event|LY Cohort 5|70 mg single dose of LY3079514 administered IV during a single occasion
11207378|NCT02242903|EG006|Reported Event|LY Cohort 6|210 mg single dose of LY3079514 administered IV during a single occasion
11207379|NCT02242981|BG000|Baseline|LY2623091|Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
11207380|NCT02242981|FG000|Participant Flow|LY2623091|Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 [¹⁴C]-LY2623091 (approximately 100 microcuries [µCi]) administered orally.
11207381|NCT02242981|OG000|Outcome|LY2623091|Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
11207382|NCT02242981|EG000|Reported Event|LY2623091|Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
11207383|NCT02242994|BG000|Baseline|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
11207384|NCT02242994|FG000|Participant Flow|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
11207385|NCT02242994|OG000|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
11207386|NCT02242994|EG000|Reported Event|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
11207387|NCT02243007|BG000|Baseline|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
11207388|NCT02243007|BG001|Baseline|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
11207389|NCT02243007|BG002|Baseline|Total|Total of all reporting groups
11207390|NCT02243007|FG000|Participant Flow|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
11207391|NCT02243007|FG001|Participant Flow|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
11207392|NCT02243007|OG000|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
11207393|NCT02243007|OG001|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
11207394|NCT02243007|EG000|Reported Event|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
11244385|NCT02510664|EG001|Reported Event|Parent|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessment"
10847914|NCT00286728|EG000|Reported Event|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
10847915|NCT00286728|EG001|Reported Event|Arm 2 Usual Care|Usual care
10968877|NCT00903383|FG002|Participant Flow|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
11207395|NCT02243007|EG001|Reported Event|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
11207396|NCT02243046|BG000|Baseline|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207397|NCT02243046|BG001|Baseline|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207398|NCT02243046|BG002|Baseline|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207399|NCT02243046|BG003|Baseline|Total|Total of all reporting groups
11207400|NCT02243046|FG000|Participant Flow|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207401|NCT02243046|FG001|Participant Flow|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207402|NCT02243046|FG002|Participant Flow|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207403|NCT02243046|OG000|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207404|NCT02243046|OG001|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207405|NCT02243046|OG002|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207406|NCT02243046|EG000|Reported Event|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
11207407|NCT02243046|EG001|Reported Event|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
10968878|NCT00903383|FG003|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
11207408|NCT02243046|EG002|Reported Event|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
11207409|NCT02243176|BG000|Baseline|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
11207410|NCT02243176|BG001|Baseline|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
11207411|NCT02243176|BG002|Baseline|Total|Total of all reporting groups
11207412|NCT02243176|FG000|Participant Flow|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
11207413|NCT02243176|FG001|Participant Flow|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
10968879|NCT00903383|OG000|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
10968880|NCT00903383|OG001|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
10968881|NCT00903383|OG002|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
10968882|NCT00903383|OG003|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
10968883|NCT00903383|EG000|Reported Event|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
10968884|NCT00903383|EG001|Reported Event|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
10968885|NCT00903383|EG002|Reported Event|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
10968886|NCT00903383|EG003|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
10968887|NCT00903409|BG000|Baseline|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
10968888|NCT00903409|BG001|Baseline|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
10968889|NCT00903409|BG002|Baseline|Total|Total of all reporting groups
10968890|NCT00903409|FG000|Participant Flow|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
10968891|NCT00903409|FG001|Participant Flow|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
10968892|NCT00903409|OG000|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
10968893|NCT00903409|OG001|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
10968894|NCT00903409|OG002|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
10968895|NCT00903409|EG000|Reported Event|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
10968896|NCT00903409|EG001|Reported Event|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
11207414|NCT02243176|OG000|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
10968897|NCT00903409|EG002|Reported Event|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
10968898|NCT00903448|BG000|Baseline|Entire Study Population|
10968899|NCT00903448|FG000|Participant Flow|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968900|NCT00903448|FG001|Participant Flow|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968901|NCT00903448|OG000|Outcome|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968902|NCT00903448|OG001|Outcome|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968903|NCT00903448|EG000|Reported Event|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968904|NCT00903448|EG001|Reported Event|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
10968905|NCT00903617|BG000|Baseline|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968906|NCT00903617|BG001|Baseline|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968907|NCT00903617|BG002|Baseline|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968908|NCT00903617|BG003|Baseline|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968909|NCT00903617|BG004|Baseline|Total|Total of all reporting groups
10968910|NCT00903617|FG000|Participant Flow|GSK256073 5 mg|Eligible participants received GSK256073 5 milligrams (mg) oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968911|NCT00903617|FG001|Participant Flow|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968912|NCT00903617|FG002|Participant Flow|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968913|NCT00903617|FG003|Participant Flow|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968914|NCT00903617|OG000|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968915|NCT00903617|OG001|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968916|NCT00903617|OG002|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968917|NCT00903617|OG001|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968918|NCT00903617|OG003|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968919|NCT00903617|EG000|Reported Event|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968920|NCT00903617|EG001|Reported Event|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
11207415|NCT02243176|OG001|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
11207416|NCT02243176|EG000|Reported Event|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
11207417|NCT02243176|EG001|Reported Event|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
11207418|NCT02243202|BG000|Baseline|Placebo|Participants received placebo tablets orally for 26 weeks.
11207419|NCT02243202|BG001|Baseline|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
11207420|NCT02243202|BG002|Baseline|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
11207421|NCT02243202|BG003|Baseline|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
11207422|NCT02243202|BG004|Baseline|Total|Total of all reporting groups
11207423|NCT02243202|FG000|Participant Flow|Placebo|Participants received placebo tablets orally for 26 weeks.
11207424|NCT02243202|FG001|Participant Flow|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
11207425|NCT02243202|FG002|Participant Flow|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
11207426|NCT02243202|FG003|Participant Flow|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
10818743|NCT00039377|OG001|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818744|NCT00039377|EG000|Reported Event|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818745|NCT00039377|EG001|Reported Event|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818746|NCT00039377|EG002|Reported Event|Patients Who Did Not Undergo Transplant|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
10818747|NCT00039741|BG000|Baseline|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
10818748|NCT00039741|BG001|Baseline|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
10818749|NCT00039741|BG002|Baseline|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
10818750|NCT00039741|BG003|Baseline|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
10818751|NCT00039741|BG004|Baseline|Total|Total of all reporting groups
10818752|NCT00039741|FG000|Participant Flow|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
10818753|NCT00039741|FG001|Participant Flow|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
10818754|NCT00039741|FG002|Participant Flow|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
10818755|NCT00039741|FG003|Participant Flow|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
10818756|NCT00039741|OG000|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
10818757|NCT00039741|OG001|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
10818758|NCT00039741|OG002|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
10818759|NCT00039741|OG003|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
10818760|NCT00039741|EG000|Reported Event|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
10818761|NCT00039741|EG001|Reported Event|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
10818762|NCT00039741|EG002|Reported Event|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
10818763|NCT00039741|EG003|Reported Event|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
10818764|NCT00039871|BG000|Baseline|PegIntron Plus Rebetol|
10818765|NCT00039871|FG000|Participant Flow|PegIntron Plus Rebetol|
10818766|NCT00039871|OG000|Outcome|PegIntron Plus Rebetol|
10818767|NCT00039871|EG000|Reported Event|PegIntron Plus Rebetol|
10818768|NCT00040365|BG000|Baseline|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
11207427|NCT02243202|OG000|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
11207428|NCT02243202|OG001|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
11207429|NCT02243202|OG002|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
10818769|NCT00040365|FG000|Participant Flow|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
10818770|NCT00040365|OG000|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
10818771|NCT00040365|EG000|Reported Event|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
10818772|NCT00040443|BG000|Baseline|CX516|"CX516 - 900 mg~CX516 (Ampalex®)"
10818773|NCT00040443|BG001|Baseline|Placebo|"Placebo to CX516 900 mg~CX516 (Ampalex®)"
10818774|NCT00040443|BG002|Baseline|Total|Total of all reporting groups
10818775|NCT00040443|FG000|Participant Flow|CX516|"CX516 - 900 mg~CX516 (Ampalex®)"
10818776|NCT00040443|FG001|Participant Flow|Placebo|"Placebo to CX516 900 mg~CX516 (Ampalex®)"
10818777|NCT00040443|OG000|Outcome|CX516|"CX516 - 900 mg (3 X 300 mg)~CX516 (Ampalex®)"
10818778|NCT00040443|OG001|Outcome|Placebo|"Placebo to CX516 300 mg~CX516 (Ampalex®)"
10818779|NCT00040443|EG000|Reported Event|CX516|"CX516 - 900 mg (3 X 300 mg)~CX516 (Ampalex®)"
10818780|NCT00040443|EG001|Reported Event|Placebo|"Placebo to CX516 300 mg~CX516 (Ampalex®)"
10818781|NCT00040664|BG000|Baseline|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
10818782|NCT00040664|FG000|Participant Flow|Overall Fosamprenavir (FPV)/Ritonavir(RTV)|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
10818783|NCT00040664|FG001|Participant Flow|2-5 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
10818784|NCT00040664|FG002|Participant Flow|6-11 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
10818785|NCT00040664|FG003|Participant Flow|12-18 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
10818786|NCT00040664|OG000|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
10818787|NCT00040664|OG000|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
10818788|NCT00040664|OG001|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
10818789|NCT00040664|OG000|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
10818790|NCT00040664|OG000|Outcome|FPV Tablet|Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
10818791|NCT00040664|OG001|Outcome|FPV Oral Suspension|Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
10818792|NCT00040664|OG000|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
10818793|NCT00040664|OG001|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
10818794|NCT00040664|OG002|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
10818795|NCT00040664|OG003|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
10818796|NCT00040664|OG000|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
10818797|NCT00040664|OG001|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
10818798|NCT00040664|OG002|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
10818799|NCT00040664|OG003|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
10818800|NCT00040664|OG000|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
10818801|NCT00040664|EG000|Reported Event|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
10818802|NCT00040742|BG000|Baseline|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
10818803|NCT00040742|BG001|Baseline|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818804|NCT00040742|BG002|Baseline|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818805|NCT00040742|BG003|Baseline|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
10818806|NCT00040742|BG004|Baseline|Total|Total of all reporting groups
10818807|NCT00040742|FG000|Participant Flow|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
10818808|NCT00040742|FG001|Participant Flow|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818809|NCT00040742|FG002|Participant Flow|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818810|NCT00040742|FG003|Participant Flow|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
10968921|NCT00903617|EG002|Reported Event|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968922|NCT00903617|EG003|Reported Event|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
10968923|NCT00903630|BG000|Baseline|Phase 1 - Dose Level 1|
10968924|NCT00903630|BG001|Baseline|Phase 1 - Dose Level 2|
10968925|NCT00903630|BG002|Baseline|Phase 2|
10968926|NCT00903630|BG003|Baseline|Total|Total of all reporting groups
10968927|NCT00903630|FG000|Participant Flow|Phase 1 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
10968928|NCT00903630|FG001|Participant Flow|Phase 1 - Dose Level 2|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
10968929|NCT00903630|FG002|Participant Flow|Phase 2 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
10968930|NCT00903630|OG000|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968931|NCT00903630|OG000|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968932|NCT00903630|OG001|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968933|NCT00903630|OG002|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968934|NCT00903630|OG000|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968935|NCT00903630|EG000|Reported Event|Phase 1 - Dose Level 1|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968936|NCT00903630|EG001|Reported Event|Phase 1 - Dose Level 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968937|NCT00903630|EG002|Reported Event|Phase 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
10968938|NCT00903682|BG000|Baseline|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
10968939|NCT00903682|BG001|Baseline|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
10968940|NCT00903682|BG002|Baseline|Total|Total of all reporting groups
11207430|NCT02243202|OG003|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
10968941|NCT00903682|FG000|Participant Flow|Etravirine|Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
10968942|NCT00903682|FG001|Participant Flow|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
10968943|NCT00903682|OG000|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
10968944|NCT00903682|OG001|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
10968945|NCT00903682|EG000|Reported Event|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
10968946|NCT00903682|EG001|Reported Event|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
11207431|NCT02243202|EG000|Reported Event|Placebo|Participants received placebo tablets orally for 26 weeks.
11207432|NCT02243202|EG001|Reported Event|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
11207433|NCT02243202|EG002|Reported Event|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
10968947|NCT00903695|BG000|Baseline|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
10968948|NCT00903695|BG001|Baseline|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
10968949|NCT00903695|BG002|Baseline|Total|Total of all reporting groups
10968950|NCT00903695|FG000|Participant Flow|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
10968951|NCT00903695|FG001|Participant Flow|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
10968952|NCT00903695|OG000|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
10968953|NCT00903695|OG001|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
10968954|NCT00903695|OG000|Outcome|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
10968955|NCT00903695|OG001|Outcome|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
10968956|NCT00903695|EG000|Reported Event|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
10968957|NCT00903695|EG001|Reported Event|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
10968958|NCT00903760|BG000|Baseline|Decitabine + Clofarabine|Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
10968959|NCT00903760|BG001|Baseline|Decitabine|Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.
10968960|NCT00903760|BG002|Baseline|Total|Total of all reporting groups
11207434|NCT02243202|EG003|Reported Event|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
11207435|NCT02243280|BG000|Baseline|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
11207436|NCT02243280|BG001|Baseline|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
11207437|NCT02243280|BG002|Baseline|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
10818811|NCT00040742|OG000|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
10968961|NCT00903760|FG000|Participant Flow|Decitabine + Clofarabine|Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
10968962|NCT00903760|FG001|Participant Flow|Decitabine|Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.
10968963|NCT00903760|OG000|Outcome|Decitabine + Clofarabine|Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
10968964|NCT00903760|OG001|Outcome|Decitabine|Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.
10968965|NCT00903760|EG000|Reported Event|Decitabine + Clofarabine|Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
10968966|NCT00903760|EG001|Reported Event|Decitabine|Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.
10968967|NCT00903786|BG000|Baseline|Perampanel|"Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).~The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest."
10968968|NCT00903786|FG000|Participant Flow|Perampanel|"Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).~The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest."
10968969|NCT00903786|OG000|Outcome|Perampanel|"Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).~The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest."
10968970|NCT00903786|OG000|Outcome|Perampanel|"Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-mg tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).~The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest."
10968971|NCT00903786|EG000|Reported Event|Perampanel|"Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).~The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest."
10968972|NCT00903877|BG000|Baseline|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
11092554|NCT01540513|FG000|Participant Flow|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
10968973|NCT00903877|FG000|Participant Flow|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
10968974|NCT00903877|OG000|Outcome|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
10968975|NCT00903877|EG000|Reported Event|Placebo Followed by T3|All participants receive placebo, followed by 25 mcg of T3.
10968976|NCT00903929|BG000|Baseline|Eltrombopag|Eltrombopag: dose escalation
10968977|NCT00903929|FG000|Participant Flow|Eltrombopag 75 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
10968978|NCT00903929|FG001|Participant Flow|Eltrombopag 150 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
10968979|NCT00903929|FG002|Participant Flow|Eltrombopag 225 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
10968980|NCT00903929|FG003|Participant Flow|Eltrombopag 300 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
10968981|NCT00903929|OG000|Outcome|All Participants|
10968982|NCT00903929|OG000|Outcome|Eltrombopag|Eltrombopag: dose escalation
10968983|NCT00903929|EG000|Reported Event|Eltrombopag|Eltrombopag: dose escalation
10968984|NCT00903968|BG000|Baseline|All Phase I Particiapnts|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
10968985|NCT00903968|BG001|Baseline|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
10968986|NCT00903968|BG002|Baseline|Total|Total of all reporting groups
10968987|NCT00903968|FG000|Participant Flow|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968988|NCT00903968|FG001|Participant Flow|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968989|NCT00903968|FG002|Participant Flow|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968990|NCT00903968|FG003|Participant Flow|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
11207438|NCT02243280|BG003|Baseline|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
10968991|NCT00903968|FG004|Participant Flow|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968992|NCT00903968|FG005|Participant Flow|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968993|NCT00903968|FG006|Participant Flow|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968994|NCT00903968|FG007|Participant Flow|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
10968995|NCT00903968|OG000|Outcome|All Phase I Particiapnts|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
10968996|NCT00903968|OG000|Outcome|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968997|NCT00903968|OG001|Outcome|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968998|NCT00903968|OG002|Outcome|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10968999|NCT00903968|OG003|Outcome|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969000|NCT00903968|OG004|Outcome|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969001|NCT00903968|OG005|Outcome|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969002|NCT00903968|OG006|Outcome|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
11207439|NCT02243280|BG004|Baseline|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
10818812|NCT00040742|OG001|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818813|NCT00040742|OG002|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818814|NCT00040742|OG003|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
10818815|NCT00040742|EG000|Reported Event|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
10818816|NCT00040742|EG001|Reported Event|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818817|NCT00040742|EG002|Reported Event|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
10818818|NCT00040742|EG003|Reported Event|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
10818819|NCT00040846|BG000|Baseline|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
10818820|NCT00040846|BG001|Baseline|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818821|NCT00040846|BG002|Baseline|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818822|NCT00040846|BG003|Baseline|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818823|NCT00040846|BG004|Baseline|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818824|NCT00040846|BG005|Baseline|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818825|NCT00040846|BG006|Baseline|Total|Total of all reporting groups
10847916|NCT00286741|BG000|Baseline|Arm 1|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
10847917|NCT00286741|BG001|Baseline|Arm 2|control
10847918|NCT00286741|BG002|Baseline|Total|Total of all reporting groups
11207440|NCT02243280|BG005|Baseline|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
10818826|NCT00040846|FG000|Participant Flow|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
10818827|NCT00040846|FG001|Participant Flow|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818828|NCT00040846|FG002|Participant Flow|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818829|NCT00040846|FG003|Participant Flow|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818830|NCT00040846|FG004|Participant Flow|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818831|NCT00040846|FG005|Participant Flow|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818832|NCT00040846|OG000|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
10818833|NCT00040846|OG001|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818834|NCT00040846|OG002|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
11207441|NCT02243280|BG006|Baseline|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
10818835|NCT00040846|OG003|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818836|NCT00040846|OG004|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818837|NCT00040846|OG005|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818838|NCT00040846|EG000|Reported Event|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
10818839|NCT00040846|EG001|Reported Event|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818840|NCT00040846|EG002|Reported Event|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818841|NCT00040846|EG003|Reported Event|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818842|NCT00040846|EG004|Reported Event|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818843|NCT00040846|EG005|Reported Event|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
10818844|NCT00040937|BG000|Baseline|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
11207442|NCT02243280|BG007|Baseline|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
10818845|NCT00040937|FG000|Participant Flow|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
10818846|NCT00040937|OG000|Outcome|Induction/PBSC Mobilization|
10818847|NCT00040937|OG000|Outcome|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
10818848|NCT00040937|EG000|Reported Event|Induction/PBSC Mobilization|
10818849|NCT00040937|EG001|Reported Event|Autologous PBSCT|
10818850|NCT00040937|EG002|Reported Event|Prednisone + Thalidomide|
10818851|NCT00041067|BG000|Baseline|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
10818852|NCT00041067|FG000|Participant Flow|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
10818853|NCT00041067|OG000|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
10818854|NCT00041067|OG000|Outcome|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
10818855|NCT00041067|EG000|Reported Event|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
10818856|NCT00041080|BG000|Baseline|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
10818857|NCT00041080|BG001|Baseline|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
10818858|NCT00041080|BG002|Baseline|Total|Total of all reporting groups
10818859|NCT00041080|FG000|Participant Flow|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
10818860|NCT00041080|FG001|Participant Flow|Grp - 2|Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
10818861|NCT00041080|OG000|Outcome|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
10818862|NCT00041080|OG001|Outcome|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
10818863|NCT00041080|EG000|Reported Event|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
10818864|NCT00041080|EG001|Reported Event|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
10818865|NCT00041119|BG000|Baseline|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818866|NCT00041119|BG001|Baseline|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818867|NCT00041119|BG002|Baseline|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818868|NCT00041119|BG003|Baseline|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818869|NCT00041119|BG004|Baseline|Total|Total of all reporting groups
10818870|NCT00041119|FG000|Participant Flow|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818871|NCT00041119|FG001|Participant Flow|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818872|NCT00041119|FG002|Participant Flow|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818873|NCT00041119|FG003|Participant Flow|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818874|NCT00041119|OG000|Outcome|4 Cycles (Arm I and Arm III Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818875|NCT00041119|OG001|Outcome|6 Cycles (Arm II and Arm IV Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
11207443|NCT02243280|BG008|Baseline|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
10969003|NCT00903968|OG007|Outcome|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
10969004|NCT00903968|OG000|Outcome|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
10969005|NCT00903968|EG000|Reported Event|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969006|NCT00903968|EG001|Reported Event|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969007|NCT00903968|EG002|Reported Event|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969008|NCT00903968|EG003|Reported Event|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969009|NCT00903968|EG004|Reported Event|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969010|NCT00903968|EG005|Reported Event|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969011|NCT00903968|EG006|Reported Event|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
10969012|NCT00903968|EG007|Reported Event|All Phase I Participants|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
10969013|NCT00903968|EG008|Reported Event|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
10969014|NCT00904007|BG000|Baseline|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
10969015|NCT00904007|BG001|Baseline|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
10969016|NCT00904007|BG002|Baseline|Total|Total of all reporting groups
10969017|NCT00904007|FG000|Participant Flow|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
10969018|NCT00904007|FG001|Participant Flow|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
10969019|NCT00904007|OG000|Outcome|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
10969020|NCT00904007|OG001|Outcome|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
10969021|NCT00904007|OG000|Outcome|SE Game Cohort|"Will receive ISE intervention.~Interactive Spaced Education (ISE) --- online education: ISE is a novel educational methodology based on the spacing effect, the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions."
10969022|NCT00904007|OG001|Outcome|Control Cohort|The control cohort will receive identical content online (with no ISE)
10969023|NCT00904007|EG000|Reported Event|Arm 1|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
10969024|NCT00904007|EG001|Reported Event|Arm 2|Control clinicians received identical educational content in an online posting with email reminders.
10969025|NCT00904033|BG000|Baseline|Multivitamin|"Multivitamin used as control group.~Multivitamin"
10969026|NCT00904033|BG001|Baseline|Exericse|"Exercise consisting of progressive walking and resistance band training.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969027|NCT00904033|BG002|Baseline|Calcitriol|"Calcitriol pill taken once per week.~Calcitriol: Calcitriol tablet taken once per week."
11207444|NCT02243280|BG009|Baseline|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
10969028|NCT00904033|BG003|Baseline|Calcitriol and Exercise|"Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.~Calcitriol: Calcitriol tablet taken once per week.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969029|NCT00904033|BG004|Baseline|Total|Total of all reporting groups
10969030|NCT00904033|FG000|Participant Flow|Multivitamin|"Multivitamin used as control group.~Multivitamin"
10969031|NCT00904033|FG001|Participant Flow|Exericse|"Exercise consisting of progressive walking and resistance band training.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969032|NCT00904033|FG002|Participant Flow|Calcitriol|"Calcitriol pill taken once per week.~Calcitriol: Calcitriol tablet taken once per week."
10969033|NCT00904033|FG003|Participant Flow|Calcitriol and Exercise|"Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.~Calcitriol: Calcitriol tablet taken once per week.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969034|NCT00904033|OG000|Outcome|No Exercise|Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week
10969035|NCT00904033|OG001|Outcome|Exercise|"Exercise Arm: Exercise consisting of progressive walking and resistance band training~Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise"
10969036|NCT00904033|OG000|Outcome|No Calcitriol|Multivitamin Arm + Exercise Arm:Exercise consisting of progressive walking and resistance band training
10969037|NCT00904033|OG001|Outcome|Calcitriol|"Calcitriol Arm: Calcitriol pill taken once per week~and~Calcitriol+Exercise Arm:Exercise consisting of progressive walking and resistance band training"
10969038|NCT00904033|OG001|Outcome|Calcitriol|"Calcitriol Arm: Calcitriol pill taken once per week~and~Calcitriol+ Exercise Arm:Exercise consisting of progressive walking and resistance band training"
11207445|NCT02243280|BG010|Baseline|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
10969039|NCT00904033|EG000|Reported Event|Multivitamin|"Multivitamin used as control group.~Multivitamin"
10969040|NCT00904033|EG001|Reported Event|Exericse|"Exercise consisting of progressive walking and resistance band training.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969041|NCT00904033|EG002|Reported Event|Calcitriol|"Calcitriol pill taken once per week.~Calcitriol: Calcitriol tablet taken once per week."
10969042|NCT00904033|EG003|Reported Event|Calcitriol and Exercise|"Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.~Calcitriol: Calcitriol tablet taken once per week.~Exercise: Exercise consisting of progressive walking and resistance band training"
10969043|NCT00904150|BG000|Baseline|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
10969044|NCT00904150|BG001|Baseline|2 No Migraine|Caucasian women with no personal history of migraine
10969045|NCT00904150|BG002|Baseline|Total|Total of all reporting groups
10969046|NCT00904150|FG000|Participant Flow|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
10969047|NCT00904150|FG001|Participant Flow|2 No Migraine|Caucasian women with no personal history of migraine
10969048|NCT00904150|OG000|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
10969049|NCT00904150|OG001|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
10969050|NCT00904150|EG000|Reported Event|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
10969051|NCT00904150|EG001|Reported Event|2 No Migraine|Caucasian women with no personal history of migraine
10969052|NCT00904215|BG000|Baseline|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
10969053|NCT00904215|FG000|Participant Flow|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
10969054|NCT00904215|OG000|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
10969055|NCT00904215|EG000|Reported Event|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
10969056|NCT00904345|BG000|Baseline|Treatment: Cetuximab + RT|Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
10969057|NCT00904345|FG000|Participant Flow|Treatment With Cetuximab + RT|Patients received a single loading dose of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
10969058|NCT00904345|OG000|Outcome|Treatment: Cetuximab + RT|Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
10969059|NCT00904345|EG000|Reported Event|Treatment: Cetuximab + RT|Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
10969060|NCT00904371|BG000|Baseline|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
10969061|NCT00904371|FG000|Participant Flow|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
10969062|NCT00904371|OG000|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
10969063|NCT00904371|EG000|Reported Event|Micardis® 80mg MicardisPlus® 80/12.5 mg|
10969064|NCT00904488|BG000|Baseline|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
10969065|NCT00904488|BG001|Baseline|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
10969066|NCT00904488|BG002|Baseline|Total|Total of all reporting groups
11207446|NCT02243280|BG011|Baseline|Total|Total of all reporting groups
11207447|NCT02243280|FG000|Participant Flow|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
11207448|NCT02243280|FG001|Participant Flow|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
11207449|NCT02243280|FG002|Participant Flow|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
11207450|NCT02243280|FG003|Participant Flow|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
11207451|NCT02243280|FG004|Participant Flow|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
11207452|NCT02243280|FG005|Participant Flow|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
11207453|NCT02243280|FG006|Participant Flow|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
10818876|NCT00041119|OG000|Outcome|Arm V (Arm I and Arm II Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
10818877|NCT00041119|OG001|Outcome|Arm VI (Arm III and Arm IV) Combined|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818878|NCT00041119|OG000|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
10818879|NCT00041119|OG001|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
10818880|NCT00041119|OG000|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
10818881|NCT00041119|OG001|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
10818882|NCT00041119|EG000|Reported Event|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818883|NCT00041119|EG001|Reported Event|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818884|NCT00041119|EG002|Reported Event|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
10818885|NCT00041119|EG003|Reported Event|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
10818886|NCT00041132|BG000|Baseline|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
10818887|NCT00041132|FG000|Participant Flow|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
10818888|NCT00041132|OG000|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
10818889|NCT00041132|EG000|Reported Event|Hyper-CVAD + MTX/Ara-C + Rituximab|
10818890|NCT00041470|BG000|Baseline|Phase I/II|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
10847919|NCT00286741|FG000|Participant Flow|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
10847920|NCT00286741|FG001|Participant Flow|Control|control
10847921|NCT00286741|OG000|Outcome|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
10847922|NCT00286741|OG001|Outcome|Control|Treatment as Usual Control
10847923|NCT00286741|OG000|Outcome|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
10847924|NCT00286741|OG001|Outcome|Treatment as Usual Control|control
10847925|NCT00286741|OG001|Outcome|Control|control
10847926|NCT00286741|EG000|Reported Event|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
10847927|NCT00286741|EG001|Reported Event|Control|Treatment as Usual Control
10847928|NCT00286754|BG000|Baseline|Stage-Matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
10847929|NCT00286754|BG001|Baseline|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
10847930|NCT00286754|BG002|Baseline|Usual Care (UC)|treatment as usual for hypertension
10847931|NCT00286754|BG003|Baseline|Total|Total of all reporting groups
10847932|NCT00286754|FG000|Participant Flow|Stage-matched Intervention (SM)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
10847933|NCT00286754|FG001|Participant Flow|Health Education Intervention (HEI)|6 monthly phone calls of non-tailored counseling for diet, medication and exercise
10847934|NCT00286754|FG002|Participant Flow|Usual Care (UC)|treatment as usual with no additional counseling
10847935|NCT00286754|OG000|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
10847936|NCT00286754|OG001|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
10847937|NCT00286754|OG002|Outcome|Usual Care (UC)|treatment as usual for hypertension
10847938|NCT00286754|OG001|Outcome|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
10847939|NCT00286754|OG000|Outcome|Stage-matched Intervention (SMI)|6 monthly calls targeting diet, medication and exercise adherence tailored using the Transtheoretical Model
10847940|NCT00286754|OG001|Outcome|Health Education Intervention (HEI)|6 monthly calls of non-tailored education about diet, medication and exercise recommendations
10847941|NCT00286754|OG002|Outcome|Usual Care (UC)|Treatment as usual for hypertension with no counseling
10847942|NCT00286754|OG001|Outcome|Health Education Intervention (HEI)|6 months of non-tailored counseling for diet, medication and exercise
10847943|NCT00286754|OG002|Outcome|Usual Care (UC)|treatment as usual
10847944|NCT00286754|EG000|Reported Event|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
10847945|NCT00286754|EG001|Reported Event|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
10847946|NCT00286754|EG002|Reported Event|Usual Care (UC)|treatment as usual for hypertension
10847947|NCT00286949|BG000|Baseline|Atomoxetine|Atomoxetine (Strattera): Open label, no comparator
10847948|NCT00286949|FG000|Participant Flow|Atomoxetine Open Label|This open-label, uncontrolled, single arm, flexible dose trial consisted of atomoxetine (Strattera) in 25 mg capsules initiated at 25 mg/day in the morning (Week 1) and advancing to 50mg/at (weeks 2-4), 75 mg/day (Week 5), and 100 mg/day (Weeks 6-8). Dose reductions were allowed to a minimum of 2.5 mg/day for intolerance.
10847949|NCT00286949|OG000|Outcome|Atomoxetine Open Label|Active open label drug, no comparator; Atomoxetine (Strattera)
10847950|NCT00286949|OG000|Outcome|Atomoxetine (Strattera)|"Open-Label Uncontrolled Active Drug Intervention, No comparator~Atomoxetine: Open Label uncontrolled active Drug intervention"
10847951|NCT00286949|OG000|Outcome|Atomoxetine|"Active open label drug, no comparator~Atomoxetine (Strattera)"
10847952|NCT00286949|EG000|Reported Event|Atomoxetine|"Open label, no comparator~Atomoxetine (Strattera)"
10847953|NCT00287053|BG000|Baseline|1. Inactive Placebo Pill|Inactive placebo pill
10847954|NCT00287053|BG001|Baseline|2. Active Medication|Active medication
10847955|NCT00287053|BG002|Baseline|Total|Total of all reporting groups
10847956|NCT00287053|FG000|Participant Flow|1. Inactive Placebo Pill|Inactive placebo pill
10847957|NCT00287053|FG001|Participant Flow|2. Active Medication|Active medication
10847958|NCT00287053|OG000|Outcome|1. Inactive Placebo Pill|Inactive placebo pill
10847959|NCT00287053|OG001|Outcome|2. Active Medication|Active medication
10847960|NCT00287053|EG000|Reported Event|1. Inactive Placebo Pill|Inactive placebo pill
10847961|NCT00287053|EG001|Reported Event|2. Active Medication|Active medication
10847962|NCT00287079|BG000|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
10847963|NCT00287079|BG001|Baseline|No Treatment|Participants in this group did not receive any treatment.
10847964|NCT00287079|BG002|Baseline|Total|Total of all reporting groups
10847965|NCT00287079|FG000|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
10847966|NCT00287079|FG001|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
10847967|NCT00287079|OG000|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
10847968|NCT00287079|OG001|Outcome|No Treatment|Participants in this group did not receive any treatment.
10847969|NCT00287079|EG000|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
10969067|NCT00904488|FG000|Participant Flow|Furosemide Dose Escalation|Furosemide dose escalation given either as IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
10969068|NCT00904488|FG001|Participant Flow|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
10969069|NCT00904488|OG000|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
10969070|NCT00904488|OG001|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
10969071|NCT00904488|EG000|Reported Event|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
10969072|NCT00904488|EG001|Reported Event|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
10969073|NCT00904618|BG000|Baseline|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
10969074|NCT00904618|FG000|Participant Flow|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
10969075|NCT00904618|OG000|Outcome|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
10969076|NCT00904618|OG000|Outcome|'Hammock' Technique|The 'Hammock' technique is similar to the transobturator tape dissection.
10969077|NCT00904618|OG001|Outcome|U-Method|The U-Method is similar to the retropubic tape dissection
10969078|NCT00904618|OG001|Outcome|U-Method|The 'U-Method' is similar to the retropubic tape dissection.
10969079|NCT00904618|EG000|Reported Event|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
10969080|NCT00904670|BG000|Baseline|Entire Study Population|Includes all randomized participants who received at least 1 dose of study medication.
10969081|NCT00904670|FG000|Participant Flow|OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)|Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
10969082|NCT00904670|FG001|Participant Flow|OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
10969083|NCT00904670|OG000|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
10969084|NCT00904670|OG001|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
10969085|NCT00904670|OG001|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention period.
10969086|NCT00904670|EG000|Reported Event|OL Phase (NWP06)|NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
10969087|NCT00904670|EG001|Reported Event|DB Phase (Placebo)|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
10969088|NCT00904670|EG002|Reported Event|DB Phase (NWP06)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
10969089|NCT00904722|BG000|Baseline|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
10969090|NCT00904722|FG000|Participant Flow|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
10969091|NCT00904722|OG000|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
11207454|NCT02243280|FG007|Participant Flow|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
10847970|NCT00287079|EG001|Reported Event|No Treatment|Participants in this group did not receive any treatment.
10847971|NCT00287118|BG000|Baseline|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
10847972|NCT00287118|FG000|Participant Flow|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
10847973|NCT00287118|OG000|Outcome|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
10847974|NCT00287118|EG000|Reported Event|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
10847975|NCT00287222|BG000|Baseline|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
10847976|NCT00287222|FG000|Participant Flow|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
10847977|NCT00287222|OG000|Outcome|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
10847978|NCT00287222|EG000|Reported Event|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
10847979|NCT00287287|BG000|Baseline|Lenalidomide (Revlimid)|"Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.~Lenalidomide: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day"
10847980|NCT00287287|FG000|Participant Flow|Lenalidomide (Revlimid)|"Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.~Lenalidomide: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day"
10847981|NCT00287287|OG000|Outcome|Lenalidomide (Revlimid)|Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
10847982|NCT00287287|EG000|Reported Event|Lenalidomide (Revlimid)|Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
10847983|NCT00287339|BG000|Baseline|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
10847984|NCT00287339|BG001|Baseline|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
10847985|NCT00287339|BG002|Baseline|Total|Total of all reporting groups
10847986|NCT00287339|FG000|Participant Flow|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
10847987|NCT00287339|FG001|Participant Flow|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
10847988|NCT00287339|OG000|Outcome|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
10847989|NCT00287339|OG001|Outcome|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
10847990|NCT00287339|EG000|Reported Event|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
10847991|NCT00287339|EG001|Reported Event|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
10847992|NCT00287365|BG000|Baseline|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
10847993|NCT00287365|FG000|Participant Flow|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
10847994|NCT00287365|OG000|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
10847995|NCT00287365|OG001|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
10847996|NCT00287365|EG000|Reported Event|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
10847997|NCT00287469|BG000|Baseline|Placebo|"PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum"
10969092|NCT00904722|EG000|Reported Event|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
11207455|NCT02243280|FG008|Participant Flow|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
11207456|NCT02243280|FG009|Participant Flow|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
10969093|NCT00904748|BG000|Baseline|Entire Study Population|Includes all participants who were randomized to any treatment sequence
10969094|NCT00904748|FG000|Participant Flow|Sequence 1|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
10969095|NCT00904748|FG001|Participant Flow|Sequence 2|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
10969096|NCT00904748|FG002|Participant Flow|Sequence 3|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
10969097|NCT00904748|FG003|Participant Flow|Sequence 4|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
10969098|NCT00904748|FG004|Participant Flow|Sequence 5|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
10969099|NCT00904748|FG005|Participant Flow|Sequence 6|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
10969100|NCT00904748|OG000|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
11207457|NCT02243280|FG010|Participant Flow|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
11207458|NCT02243280|OG000|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
11207459|NCT02243280|OG001|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
11207460|NCT02243280|OG002|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
11207461|NCT02243280|OG003|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
10969101|NCT00904748|OG001|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
10969102|NCT00904748|OG002|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
10969103|NCT00904748|EG000|Reported Event|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
10969104|NCT00904748|EG001|Reported Event|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
10969105|NCT00904748|EG002|Reported Event|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
10969106|NCT00904748|EG003|Reported Event|Formulation Unspecified|Sildenafil 100 mg tablet: formulation unspecified
10969107|NCT00904813|BG000|Baseline|Three-arm Randomisation: SRT|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969108|NCT00904813|BG001|Baseline|Three-arm Randomisation: SRT-delay|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969109|NCT00904813|BG002|Baseline|Three-arm Randomisation: LRT-delay|Participants included in the three-armed randomisation and allocated to long-course preoperative radiotherapy (25x5 Gy) and surgery after 4-8 weeks.
10969110|NCT00904813|BG003|Baseline|Two-arm Randomisation: SRT|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969111|NCT00904813|BG004|Baseline|Two-arm Randomisation: SRT-delay|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969112|NCT00904813|BG005|Baseline|Total|Total of all reporting groups
11207462|NCT02243280|OG004|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
11207463|NCT02243280|OG005|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
11207464|NCT02243280|OG006|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
11207465|NCT02243280|OG007|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
11207466|NCT02243280|OG008|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
10822063|NCT00074282|FG002|Participant Flow|Arm C (Alemtuzumab: PR, <PR, PD)|"For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.~Alemtuzumab"
11207467|NCT02243280|OG009|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
11207468|NCT02243280|OG010|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
11207469|NCT02243280|EG000|Reported Event|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
11207470|NCT02243280|EG001|Reported Event|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
11207471|NCT02243280|EG002|Reported Event|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis
11207472|NCT02243280|EG003|Reported Event|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis
11207473|NCT02243280|EG004|Reported Event|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
11207474|NCT02243293|BG000|Baseline|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207475|NCT02243293|BG001|Baseline|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207476|NCT02243293|BG002|Baseline|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207477|NCT02243293|BG003|Baseline|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207478|NCT02243293|BG004|Baseline|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207479|NCT02243293|BG005|Baseline|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207480|NCT02243293|BG006|Baseline|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207481|NCT02243293|BG007|Baseline|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207482|NCT02243293|BG008|Baseline|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207483|NCT02243293|BG009|Baseline|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
11207484|NCT02243293|BG010|Baseline|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
11207485|NCT02243293|BG011|Baseline|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
11207486|NCT02243293|BG012|Baseline|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207487|NCT02243293|BG013|Baseline|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207488|NCT02243293|BG014|Baseline|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
11207489|NCT02243293|BG015|Baseline|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
11207490|NCT02243293|BG016|Baseline|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
11207491|NCT02243293|BG017|Baseline|Total|Total of all reporting groups
11207492|NCT02243293|FG000|Participant Flow|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207493|NCT02243293|FG001|Participant Flow|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207494|NCT02243293|FG002|Participant Flow|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207495|NCT02243293|FG003|Participant Flow|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
10969113|NCT00904813|FG000|Participant Flow|Three-arm Randomisation: SRT|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969114|NCT00904813|FG001|Participant Flow|Three-arm Randomisation: SRT-delay|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969115|NCT00904813|FG002|Participant Flow|Three-arm Randomisation: LRT-delay|Participants included in the three-armed randomisation and allocated to long-course preoperative radiotherapy (25x5 Gy) and surgery after 4-8 weeks.
10969116|NCT00904813|FG003|Participant Flow|Two-arm Randomisation: SRT|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969117|NCT00904813|FG004|Participant Flow|Two-arm Randomisation: SRT-delay|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969118|NCT00904813|OG000|Outcome|Three-arm Randomisation: SRT|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969119|NCT00904813|OG001|Outcome|Three-arm Randomisation: SRT-delay|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969120|NCT00904813|OG002|Outcome|Three-arm Randomisation: LRT-delay|Participants included in the three-armed randomisation and allocated to long-course preoperative radiotherapy (25x5 Gy) and surgery after 4-8 weeks.
10969121|NCT00904813|OG003|Outcome|Two-arm Randomisation: SRT|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969122|NCT00904813|OG004|Outcome|Two-arm Randomisation: SRT-delay|Participants included in the two-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969123|NCT00904813|OG005|Outcome|Pooled Short-course RT: SRT|Participants assigned to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week pooled from the three-armed and two-armed randomisation.
11207496|NCT02243293|FG004|Participant Flow|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207497|NCT02243293|FG005|Participant Flow|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207498|NCT02243293|FG006|Participant Flow|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207499|NCT02243293|FG007|Participant Flow|Arm H|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207500|NCT02243293|FG008|Participant Flow|Arm I|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207501|NCT02243293|FG009|Participant Flow|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207502|NCT02243293|FG010|Participant Flow|Arm K|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207503|NCT02243293|FG011|Participant Flow|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207504|NCT02243293|FG012|Participant Flow|Arm M|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
11207505|NCT02243293|FG013|Participant Flow|Arm N|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
11207506|NCT02243293|FG014|Participant Flow|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
11207507|NCT02243293|FG015|Participant Flow|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
11207508|NCT02243293|FG016|Participant Flow|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
11207509|NCT02243293|FG017|Participant Flow|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
10818891|NCT00041470|FG000|Participant Flow|Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression"
10818892|NCT00041470|OG000|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.~Paclitaxel weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Herceptin: 4 mg/kg IV loading dose day 1"
10818893|NCT00041470|EG000|Reported Event|Weekly Paclitaxel and Vinorelbine With GCSF Support|"Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
10818894|NCT00041717|BG000|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
10818895|NCT00041717|BG001|Baseline|Placebo|Placebo : Placebo
10818896|NCT00041717|BG002|Baseline|Total|Total of all reporting groups
10818897|NCT00041717|FG000|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-sustained release (SR) : 25mg bid (twice daily)
10818898|NCT00041717|FG001|Participant Flow|Placebo|Placebo : Placebo
10818899|NCT00041717|OG000|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
10818900|NCT00041717|OG001|Outcome|Placebo|Placebo : Placebo
10818901|NCT00041717|EG000|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
10818902|NCT00041717|EG001|Reported Event|Placebo|Placebo : Placebo
10818903|NCT00041756|BG000|Baseline|Placebo Tablet|Placebo tablet dosed BID
10818904|NCT00041756|BG001|Baseline|25 mg PG-530742|25 mg PG-530742 dosed BID
10818905|NCT00041756|BG002|Baseline|50 mg PG-530742|50 mg PG-530742 dosed BID
10818906|NCT00041756|BG003|Baseline|100 mg PG-530742|100 mg PG-530742 dosed BID
10818907|NCT00041756|BG004|Baseline|200 mg PG-530742|200 mg PG-530742 dosed BID
10818908|NCT00041756|BG005|Baseline|Total|Total of all reporting groups
10818909|NCT00041756|FG000|Participant Flow|Placebo Tablet|Placebo tablet dosed BID
10818910|NCT00041756|FG001|Participant Flow|25 mg PG-530742|25 mg PG-530742 dosed BID
10818911|NCT00041756|FG002|Participant Flow|50 mg PG-530742|50 mg PG-530742 dosed BID
10818912|NCT00041756|FG003|Participant Flow|100 mg PG-530742|100 mg PG-530742 dosed BID
10818913|NCT00041756|FG004|Participant Flow|200 mg PG-530742|200 mg PG-530742 dosed BID
10818914|NCT00041756|OG000|Outcome|Placebo Tablet|Placebo tablet dosed BID
10818915|NCT00041756|OG001|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
10818916|NCT00041756|OG002|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
10818917|NCT00041756|OG003|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
10818918|NCT00041756|OG004|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
10818919|NCT00041756|EG000|Reported Event|Placebo Tablet|Placebo tablet dosed BID
10818920|NCT00041756|EG001|Reported Event|25 mg PG-530742|25 mg PG-530742 dosed BID
10818921|NCT00041756|EG002|Reported Event|50 mg PG-530742|50 mg PG-530742 dosed BID
10818922|NCT00041756|EG003|Reported Event|100 mg PG-530742|100 mg PG-530742 dosed BID
10818923|NCT00041756|EG004|Reported Event|200 mg PG-530742|200 mg PG-530742 dosed BID
10818924|NCT00041938|BG000|Baseline|Aspirin|Aspirin : 325 mg per day
10818925|NCT00041938|BG001|Baseline|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
10818926|NCT00041938|BG002|Baseline|Total|Total of all reporting groups
10818927|NCT00041938|FG000|Participant Flow|Aspirin|Aspirin : 325 mg per day
10818928|NCT00041938|FG001|Participant Flow|Warfarin|Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
10818929|NCT00041938|OG000|Outcome|Aspirin|Aspirin : 325 mg per day
10818930|NCT00041938|OG001|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
10818931|NCT00041938|EG000|Reported Event|Aspirin|Aspirin : 325 mg per day
10818932|NCT00041938|EG001|Reported Event|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
10818933|NCT00042224|BG000|Baseline|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
10818934|NCT00042224|BG001|Baseline|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
11207510|NCT02243293|FG018|Participant Flow|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207511|NCT02243293|FG019|Participant Flow|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
10818935|NCT00042224|BG002|Baseline|Total|Total of all reporting groups
10818936|NCT00042224|FG000|Participant Flow|1 Electroconvulsive Therapy With Medication|"Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Clozapine: Patients with psychotic symptoms will receive clozapine"
11207512|NCT02243293|FG020|Participant Flow|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
11207513|NCT02243293|FG021|Participant Flow|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
11207514|NCT02243293|OG000|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207515|NCT02243293|OG001|Outcome|Arm B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207516|NCT02243293|OG002|Outcome|Arm C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207517|NCT02243293|OG003|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207518|NCT02243293|OG004|Outcome|Arm E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207519|NCT02243293|OG005|Outcome|Arm F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207520|NCT02243293|OG006|Outcome|Arm G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207521|NCT02243293|OG007|Outcome|Arm J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207522|NCT02243293|OG008|Outcome|Arm L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207523|NCT02243293|OG009|Outcome|Arm O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
11207524|NCT02243293|OG010|Outcome|Arm P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
11207525|NCT02243293|OG011|Outcome|Arm Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
11207526|NCT02243293|OG012|Outcome|Arm Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207527|NCT02243293|OG013|Outcome|Arm R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207528|NCT02243293|OG014|Outcome|Arm R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
11207529|NCT02243293|OG015|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
11207530|NCT02243293|OG016|Outcome|Arm S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
11207531|NCT02243293|OG000|Outcome|Arm S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
11207532|NCT02243293|EG000|Reported Event|ARM A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207533|NCT02243293|EG001|Reported Event|ARM B|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207534|NCT02243293|EG002|Reported Event|ARM C|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
10818937|NCT00042224|FG001|Participant Flow|2 Medication Monotherapy|Clozapine: Patients with psychotic symptoms will receive clozapine
10818938|NCT00042224|OG000|Outcome|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
10818939|NCT00042224|OG001|Outcome|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
10847998|NCT00287469|BG001|Baseline|20mcg Recombinant HEV|"20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)"
10847999|NCT00287469|BG002|Baseline|Total|Total of all reporting groups
11207535|NCT02243293|EG003|Reported Event|ARM D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
11207536|NCT02243293|EG004|Reported Event|ARM E|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
10818940|NCT00042224|EG000|Reported Event|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
10818941|NCT00042224|EG001|Reported Event|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
10818942|NCT00042432|BG000|Baseline|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
10818943|NCT00042432|BG001|Baseline|Placebo|Placebo administered orally once daily
10818944|NCT00042432|BG002|Baseline|Total|Total of all reporting groups
10818945|NCT00042432|FG000|Participant Flow|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
10818946|NCT00042432|FG001|Participant Flow|Placebo|Placebo administered orally once daily
10818947|NCT00042432|OG000|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
10818948|NCT00042432|OG001|Outcome|Placebo|Placebo administered orally once daily
10818949|NCT00042432|EG000|Reported Event|Placebo|
10818950|NCT00042432|EG001|Reported Event|Cinacalcet|
11207537|NCT02243293|EG005|Reported Event|ARM F|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207538|NCT02243293|EG006|Reported Event|ARM G|ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207539|NCT02243293|EG007|Reported Event|ARM J|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
11207540|NCT02243293|EG008|Reported Event|ARM L|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207541|NCT02243293|EG009|Reported Event|ARM O|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
10818951|NCT00042666|BG000|Baseline|Enzastaurin|500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
10818952|NCT00042666|FG000|Participant Flow|Enzastaurin|500 milligrams (mg) enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
10818953|NCT00042666|OG000|Outcome|Enzastaurin|500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
10818954|NCT00042666|OG000|Outcome|Enzastaurin|500 mg enzastaurin (LY317615) was administered orally at dose in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
10818955|NCT00042666|EG000|Reported Event|Enzastaurin|500 mg enzastaurin tablets were administered in the morning within 30 minutes of a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
10818956|NCT00042939|BG000|Baseline|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
10818957|NCT00042939|BG001|Baseline|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
10818958|NCT00042939|BG002|Baseline|Total|Total of all reporting groups
10818959|NCT00042939|FG000|Participant Flow|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
10848000|NCT00287469|FG000|Participant Flow|Placebo|"PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum"
10969124|NCT00904813|OG006|Outcome|Pooled Short-course RT: SRT-delay|Participants assigned to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks pooled from the three-armed and two-armed randomisation.
10969125|NCT00904813|OG000|Outcome|Group A: Short-course RT and OTT 7 Days|Participants treated with short-course preoperative radiotherapy (5x5 Gy) with overall treatment time of 7 days.
10969126|NCT00904813|OG001|Outcome|Group B: Short-course RT and OTT 8-13 Days|Participants treated with short-course preoperative radiotherapy (5x5 Gy) with overall treatment time of 8-13 days.
10969127|NCT00904813|OG002|Outcome|Group C: Short-course RT and OTT 5-7 Weeks|Participants treated with short-course preoperative radiotherapy (5x5 Gy) with overall treatment time of 5-7 weeks.
10969128|NCT00904813|OG003|Outcome|Group D: Short-course RT and OTT 8-13 Weeks|Participants treated with short-course preoperative radiotherapy (5x5 Gy) with overall treatment time of 8-13 weeks.
10969129|NCT00904813|OG004|Outcome|Group E: Long-course RT and OTT 9-11 Weeks|Participants treated with long-course preoperative radiotherapy (25x2 Gy) with overall treatment time 9 -11 weeks.
10969130|NCT00904813|OG005|Outcome|Group F: Long-course RT and OTT 12-14 Weeks|Participants treated with long-course preoperative radiotherapy (25x2 Gy) with overall treatment time 12 - 14 weeks.
10969131|NCT00904813|OG000|Outcome|Short-course RT: SRT|Participants treated with short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969132|NCT00904813|OG001|Outcome|Short-course RT: SRT-delay|Participants treated with short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969133|NCT00904813|OG002|Outcome|Long-course RT: LRT-delay|Participants treated with long-course preoperative radiotherapy (25x5 Gy) and surgery after 4-8 weeks.
10969134|NCT00904813|EG000|Reported Event|Three-arm Randomisation: SRT|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week.
10969135|NCT00904813|EG001|Reported Event|Three-arm Randomisation: SRT-delay|Participants included in the three-armed randomisation and allocated to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks.
10969136|NCT00904813|EG002|Reported Event|Three-arm Randomisation: LRT-delay|Participants included in the three-armed randomisation and allocated to long-course preoperative radiotherapy (25x5 Gy) and surgery after 4-8 weeks.
10969137|NCT00904813|EG003|Reported Event|Pooled Short-course RT: SRT|Participants assigned to short-course preoperative radiotherapy (5x5 Gy) and surgery within 1 week pooled from both three-armed and two-armed randomisation.
10969138|NCT00904813|EG004|Reported Event|Pooled Short-course RT: SRT-delay|Participants assigned to short-course preoperative radiotherapy (5x5 Gy) and surgery after 4-8 weeks pooled from both three-armed and two-armed randomisation.
10969139|NCT00904826|BG000|Baseline|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
10969140|NCT00904826|FG000|Participant Flow|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
10969141|NCT00904826|OG000|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
10969142|NCT00904826|EG000|Reported Event|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
10969143|NCT00904839|BG000|Baseline|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969144|NCT00904839|BG001|Baseline|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969145|NCT00904839|BG002|Baseline|Total|Total of all reporting groups
10969146|NCT00904839|FG000|Participant Flow|Nintedanib 150 mg + mFolfox6|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969147|NCT00904839|FG001|Participant Flow|Nintedanib 200 mg + mFolfox6|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969148|NCT00904839|FG002|Participant Flow|Bevacizumab 5 mg + mFolfox6 (Phase II)|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969149|NCT00904839|OG000|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
10969150|NCT00904839|OG001|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969151|NCT00904839|OG000|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969152|NCT00904839|OG000|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
10969153|NCT00904839|OG001|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969154|NCT00904839|OG000|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
11207542|NCT02243293|EG010|Reported Event|ARM P|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
11207543|NCT02243293|EG011|Reported Event|ARM Q1|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
10969155|NCT00904839|OG001|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
10969156|NCT00904839|EG000|Reported Event|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
10969157|NCT00904839|EG001|Reported Event|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
10969158|NCT00904917|BG000|Baseline|Adapted PIP (Mothers)|Mothers of the mother-child dyad in the adapted PIP intervention.
10969159|NCT00904917|BG001|Baseline|Adapted PIP (Children)|Children of the mother-child dyad in the adapted PIP intervention.
10969160|NCT00904917|BG002|Baseline|Lecture (Mothers)|Mothers of the mother-child dyad in the lecture control group.
10969161|NCT00904917|BG003|Baseline|Lecture (Children)|Children of the mother-child dyad in the lecture control group.
10969162|NCT00904917|BG004|Baseline|Total|Total of all reporting groups
10969163|NCT00904917|FG000|Participant Flow|Adapted PIP (Mothers)|"Mothers participated in an adapted PIP for the families of children with a depressed African American mother.~Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies."
11207544|NCT02243293|EG012|Reported Event|ARM Q2|ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207545|NCT02243293|EG013|Reported Event|ARM R1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
11207546|NCT02243293|EG014|Reported Event|ARM R2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
11207547|NCT02243293|EG015|Reported Event|ARM S1|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
11207548|NCT02243293|EG016|Reported Event|ARM S2|ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
10969164|NCT00904917|FG001|Participant Flow|Adapted PIP (Children)|"Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.~Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies"
10969165|NCT00904917|FG002|Participant Flow|Lecture (Mothers)|"Mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
10969166|NCT00904917|FG003|Participant Flow|Lecture (Children)|"Children of mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
10969167|NCT00904917|OG000|Outcome|Adapted PIP|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
10969168|NCT00904917|OG001|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
10969169|NCT00904917|OG000|Outcome|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
10969170|NCT00904917|OG000|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
10969171|NCT00904917|OG001|Outcome|Adapted PIP (Child)|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
10969172|NCT00904917|OG002|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression.
10969173|NCT00904917|OG003|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
10969174|NCT00904917|OG001|Outcome|Adapted PIP (Child)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
10969175|NCT00904917|OG002|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
10969176|NCT00904917|EG000|Reported Event|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project.
10969177|NCT00904917|EG001|Reported Event|Lecture|Mothers received psychoeducation about depression.
10969178|NCT00904969|BG000|Baseline|Treated Participants|Participants in which a device placement was attempted.
11207549|NCT02243371|BG000|Baseline|CY/ GVAX/ CRS-207/ Nivolumab|"CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207550|NCT02243371|BG001|Baseline|CY/ GVAX/ CRS-207|"CRS-207: 1 × 10^9 CFU administered IV Day 1 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207551|NCT02243371|BG002|Baseline|Total|Total of all reporting groups
11207552|NCT02243371|FG000|Participant Flow|CY/ GVAX/ CRS-207/ Nivolumab|"CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207553|NCT02243371|FG001|Participant Flow|CY/ GVAX/ CRS-207|"CRS-207: 1 × 10^9 CFU administered IV Day 1 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207554|NCT02243371|OG000|Outcome|Arm A: CY/ GVAX/ CRS-207/ Nivolumab|"CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207555|NCT02243371|OG001|Outcome|Arm B: CY/ GVAX/ CRS-207|"CRS-207: 1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207556|NCT02243371|EG000|Reported Event|Arm A: CY/ GVAX/ CRS-207/ Nivolumab|"CRS-207: 1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207557|NCT02243371|EG001|Reported Event|Arm B: CY/ GVAX/ CRS-207|"CRS-207: 1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6~GVAX: 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2~CY: 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2"
11207558|NCT02243527|BG000|Baseline|Inspiratory Muscle Training|Inspiratory Muscle Training: 6-weeks of inspiratory muscle training
11207559|NCT02243527|BG001|Baseline|Sham-Control Inspiratory Muscle Training|"Inspiratory muscle training at a low intensity meant to elicit no physiological changes.~Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes"
11207560|NCT02243527|BG002|Baseline|Total|Total of all reporting groups
11207561|NCT02243527|FG000|Participant Flow|Inspiratory Muscle Training|Inspiratory Muscle Training: 6-weeks of inspiratory muscle training
11207562|NCT02243527|FG001|Participant Flow|Sham-Control Inspiratory Muscle Training|"Inspiratory muscle training at a low intensity meant to elicit no physiological changes.~Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes"
11207563|NCT02243527|OG000|Outcome|Inspiratory Muscle Training|Inspiratory Muscle Training: 6-weeks of inspiratory muscle training
11207564|NCT02243527|OG001|Outcome|Sham-Control Inspiratory Muscle Training|"Inspiratory muscle training at a low intensity meant to elicit no physiological changes.~Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes"
11207565|NCT02243527|EG000|Reported Event|Inspiratory Muscle Training|Inspiratory Muscle Training: 6-weeks of inspiratory muscle training
11207566|NCT02243527|EG001|Reported Event|Sham-Control Inspiratory Muscle Training|"Inspiratory muscle training at a low intensity meant to elicit no physiological changes.~Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes"
11207567|NCT02243579|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving CR) in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11207568|NCT02243579|FG000|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving CR) in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11207569|NCT02243579|OG000|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving CR) in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11207570|NCT02243579|EG000|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving CR) in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11207571|NCT02243696|BG000|Baseline|BIOTRONIK Protego DF4 Lead|Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
11207572|NCT02243696|FG000|Participant Flow|BIOTRONIK Protego DF4 Lead|Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
11207573|NCT02243696|OG000|Outcome|BIOTRONIK Protego DF4 Lead|Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
11207574|NCT02243696|EG000|Reported Event|BIOTRONIK Protego DF4 Lead|Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
11207575|NCT02243865|BG000|Baseline|Chordate System S200 + CT100 (Active Treatment)|Chordate System S200 + CT100 (active treatment) is Kinetic Oscillation Stimulation (KOS) treatment with the Chordate System S200 + CT100
11207576|NCT02243865|BG001|Baseline|Chordate System S200 + CT100 (Placebo Treatment)|Chordate System S200 + CT100 (placebo treatment), is Placebo treatment with the Chordate System S200 + CT100 without an inflated catheter and without vibrations
11207577|NCT02243865|BG002|Baseline|Total|Total of all reporting groups
10969179|NCT00904969|FG000|Participant Flow|Treated Participants|Participants in which a device placement was attempted.
10969180|NCT00904969|OG000|Outcome|Treated Participants|Participants in which a device placement was attempted.
10969181|NCT00904969|OG000|Outcome|3 Month|3 Month Follow-Up Visit
10969182|NCT00904969|OG001|Outcome|6 Month|6 Month Follow-Up Visit
10969183|NCT00904969|OG002|Outcome|12 Month|12 Month Follow-Up Visit
10969184|NCT00904969|OG003|Outcome|24 Month|24 Month Follow-Up Visit
10969185|NCT00904969|OG004|Outcome|24 Month LOCF|24 Month Visit using Last Observation Carried Forward
10969186|NCT00904969|OG005|Outcome|24 Month WCS|24 Month Visit using Worse Case Scenario
10969187|NCT00904969|OG000|Outcome|0-1 PPD|0-1 Pads per Day Use
10969188|NCT00904969|OG001|Outcome|2-3 PPD|2-3 Pads per Day Use
10969189|NCT00904969|OG002|Outcome|4-5 PPD|4-5 Pads per Day Use
10969190|NCT00904969|OG003|Outcome|6-7 PPD|6-7 Pads per Day Use
10969191|NCT00904969|OG004|Outcome|>= 10 PPD|Greater than or equal to 10 Pads per Day Use
10969192|NCT00904969|OG000|Outcome|Completely Dry|"Defined as No leakage."
10969193|NCT00904969|OG001|Outcome|Substantially Improved|"Defined as May have periodic leakage of small amounts but additional protection not needed."
10969194|NCT00904969|OG002|Outcome|Some Additional Protection May be Required|"Defined as Up to three pads per day may be needed or may wet themselves not more than once weekly."
10969195|NCT00904969|OG003|Outcome|Substantially or Totally Incontinent|"Defined as Will require more than three pads per day or may wet themselves two or more times per week."
10969196|NCT00904969|EG000|Reported Event|Treated Participants|Participants in which a device placement was attempted.
10969197|NCT00904982|BG000|Baseline|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
10969198|NCT00904982|BG001|Baseline|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
10969199|NCT00904982|BG002|Baseline|3 Incentive Group/Lottery|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken
10969200|NCT00904982|BG003|Baseline|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
10969201|NCT00904982|BG004|Baseline|Total|Total of all reporting groups
10969202|NCT00904982|FG000|Participant Flow|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
11092555|NCT01540513|OG000|Outcome|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
11207578|NCT02243865|FG000|Participant Flow|Chordate System S200 + CT100 (Active) Treatment|Chordate System S200 + control module (CT100), active treatment: 44 subjects
11207579|NCT02243865|FG001|Participant Flow|Chordate System S200 + CT100 (Placebo Treatment)|Chordate System S200 + control module (CT100), placebo treatment: 38 subjects
11207580|NCT02243865|OG000|Outcome|Chordate System S200 + CT100 (Active Treatment)|Chordate System S200 + CT100 (active treatment): 44 subjects
11207581|NCT02243865|OG001|Outcome|Chordate System S200 + CT100 (Placebo Treatment)|Chordate System S200 + CT100 (placebo treatment): 43 subjects
11207582|NCT02243865|OG000|Outcome|Chordate System S200 + CT100 (Active Treatment)|Chordate System S200 + CT100 (active treatment): 40 subjects
11207583|NCT02243865|OG001|Outcome|Chordate System S200 + CT100 (Placebo Treatment)|Chordate System S200 + CT100 (placebo treatment): 38 subjects
11207584|NCT02243865|EG000|Reported Event|Chordate System S200 + CT100 (Active Treatment)|Chordate System S200 + CT100 (active treatment): 44 subjects
11207585|NCT02243865|EG001|Reported Event|Chordate System S200 + CT100 (Placebo Treatment)|Chordate System S200 + CT100 (placebo treatment): 43 subjects
11207586|NCT02243943|BG000|Baseline|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
11207587|NCT02243943|BG001|Baseline|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
11207588|NCT02243943|BG002|Baseline|Total|Total of all reporting groups
11207589|NCT02243943|FG000|Participant Flow|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
11207590|NCT02243943|FG001|Participant Flow|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
11207591|NCT02243943|OG000|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
11207592|NCT02243943|OG001|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
11207593|NCT02243943|EG000|Reported Event|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
11207594|NCT02243943|EG001|Reported Event|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
11207595|NCT02244424|BG000|Baseline|Tools for Teen Moms Intervention Group|Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.
11207596|NCT02244424|BG001|Baseline|MIHP Standard Care|MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.
11207597|NCT02244424|BG002|Baseline|Total|Total of all reporting groups
10848001|NCT00287469|FG001|Participant Flow|20mcg Recombinant HEV|"20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)"
11207598|NCT02244424|FG000|Participant Flow|Tools for Teen Moms Intervention Group|"Tools for Teen Moms intervention group (N = 51 teen mothers) will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.~Tools for Teen Moms: The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities (challenges) for this population."
11207599|NCT02244424|FG001|Participant Flow|MIHP Standard Care|MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant. 31 teen mothers received MIHP standard care.
11207600|NCT02244424|OG000|Outcome|Tools for Teen Moms Intervention Group|Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.
11207601|NCT02244424|OG001|Outcome|MIHP Standard Care|MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.
11207602|NCT02244424|EG000|Reported Event|Tools for Teen Moms Intervention Group|Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.
11207603|NCT02244424|EG001|Reported Event|MIHP Standard Care|MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.
11207604|NCT02244580|BG000|Baseline|FinHer Patients|"Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).~RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67."
11207605|NCT02244580|FG000|Participant Flow|MammaTyper™|"MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.~MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67."
11207606|NCT02244580|OG000|Outcome|Luminal A|Patients subtyped as Luminal A with DDFS determined 5 years after randomisation
10818960|NCT00042939|FG001|Participant Flow|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
10818961|NCT00042939|OG000|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
10818962|NCT00042939|OG001|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
10818963|NCT00042939|EG000|Reported Event|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
10818964|NCT00042939|EG001|Reported Event|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
10818965|NCT00042991|BG000|Baseline|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818966|NCT00042991|BG001|Baseline|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818967|NCT00042991|BG002|Baseline|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818968|NCT00042991|BG003|Baseline|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818969|NCT00042991|BG004|Baseline|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818970|NCT00042991|BG005|Baseline|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818971|NCT00042991|BG006|Baseline|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818972|NCT00042991|BG007|Baseline|Total|Total of all reporting groups
10818973|NCT00042991|FG000|Participant Flow|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818974|NCT00042991|FG001|Participant Flow|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
11207607|NCT02244580|OG001|Outcome|Combined Subtype|Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
11207608|NCT02244580|OG000|Outcome|Patients With MKI67 mRNA Determination|Patients with low MKI67 mRNA
10818975|NCT00042991|FG002|Participant Flow|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818976|NCT00042991|FG003|Participant Flow|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818977|NCT00042991|FG004|Participant Flow|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818978|NCT00042991|FG005|Participant Flow|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818979|NCT00042991|FG006|Participant Flow|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
10818980|NCT00042991|OG000|Outcome|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 100 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
10818981|NCT00042991|OG001|Outcome|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 250 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
10818982|NCT00042991|OG002|Outcome|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 375 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
10818983|NCT00042991|OG000|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
10818984|NCT00042991|OG000|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
10818985|NCT00042991|OG001|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
10818986|NCT00042991|OG002|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
10818987|NCT00042991|OG003|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
10818988|NCT00042991|OG000|Outcome|Stratum IB and Stratum II|Activation and mutations of EGFR have been associated with many cancers. In this secondary objective, we identify how many patients have activated EGFR and this requires a tumor sample from patients, which is only available from supratentorial malignant glioma patients treated on Stratum IB and Stratum II.
10818989|NCT00042991|EG000|Reported Event|Stratum IA at Dose 100 mg/m^2|Brain Stem Glioma patients treated at 100 mg/m2
10818990|NCT00042991|EG001|Reported Event|Stratum IA at Dose 250 mg/m^2|Brain Stem Glioma patients treated at 250 mg/m2
10818991|NCT00042991|EG002|Reported Event|Stratum IA at Dose 375 mg/m^2|Brain Stem Glioma patients treated at 375 mg/m2
10818992|NCT00042991|EG003|Reported Event|Stratum IB at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2
10818993|NCT00042991|EG004|Reported Event|Stratum IB at Dose 250 mg/m^2|Patients with STMG treated at 250 mg/m2
10818994|NCT00042991|EG005|Reported Event|Stratum IB at Dose 375 mg/m^2|Patients with STMG treated at 375 mg/m2
10818995|NCT00042991|EG006|Reported Event|Stratum II at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2 who are receiving EIACD
10818996|NCT00043186|BG000|Baseline|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
10818997|NCT00043186|BG001|Baseline|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10818998|NCT00043186|BG002|Baseline|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10818999|NCT00043186|BG003|Baseline|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
10819000|NCT00043186|BG004|Baseline|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819001|NCT00043186|BG005|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
10819002|NCT00043186|BG006|Baseline|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819003|NCT00043186|BG007|Baseline|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
10819004|NCT00043186|BG008|Baseline|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
10819005|NCT00043186|BG009|Baseline|Total|Total of all reporting groups
10819006|NCT00043186|FG000|Participant Flow|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
10819007|NCT00043186|FG001|Participant Flow|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819008|NCT00043186|FG002|Participant Flow|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819009|NCT00043186|FG003|Participant Flow|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
10819010|NCT00043186|FG004|Participant Flow|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819011|NCT00043186|FG005|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
10819012|NCT00043186|FG006|Participant Flow|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819013|NCT00043186|FG007|Participant Flow|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
10819014|NCT00043186|FG008|Participant Flow|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
10819015|NCT00043186|OG000|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
10819016|NCT00043186|OG001|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819017|NCT00043186|OG002|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819018|NCT00043186|OG003|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
10819019|NCT00043186|OG004|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819020|NCT00043186|OG005|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
10819021|NCT00043186|OG006|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819022|NCT00043186|OG007|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
10819023|NCT00043186|OG008|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
10819024|NCT00043186|OG000|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
10819025|NCT00043186|EG000|Reported Event|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
10819026|NCT00043186|EG001|Reported Event|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819027|NCT00043186|EG002|Reported Event|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819028|NCT00043186|EG003|Reported Event|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
10819029|NCT00043186|EG004|Reported Event|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819030|NCT00043186|EG005|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
10819031|NCT00043186|EG006|Reported Event|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
10819032|NCT00043186|EG007|Reported Event|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
10819033|NCT00043186|EG008|Reported Event|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
10819034|NCT00043550|BG000|Baseline|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
10819035|NCT00043550|BG001|Baseline|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
10819036|NCT00043550|BG002|Baseline|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
10819037|NCT00043550|BG003|Baseline|Total|Total of all reporting groups
10819038|NCT00043550|FG000|Participant Flow|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
10819039|NCT00043550|FG001|Participant Flow|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
10819040|NCT00043550|FG002|Participant Flow|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
10819041|NCT00043550|OG000|Outcome|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
10819042|NCT00043550|OG001|Outcome|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
10819043|NCT00043550|OG002|Outcome|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
10819044|NCT00043550|EG000|Reported Event|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
10819045|NCT00043550|EG001|Reported Event|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
10819046|NCT00043550|EG002|Reported Event|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
10819047|NCT00043979|BG000|Baseline|Arm 1-Sibling Donors|Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
10819048|NCT00043979|BG001|Baseline|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
10819049|NCT00043979|BG002|Baseline|Total|Total of all reporting groups
10819050|NCT00043979|FG000|Participant Flow|Sibling Donors|Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
10819051|NCT00043979|FG001|Participant Flow|Recipients Cyclosporine GVHD Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received cyclosporine for GVHD prophylaxis."
10819052|NCT00043979|FG002|Participant Flow|Recipients Tacrolimus /Sirolimus Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received tacrolimus & sirolimus for GVHD prophylaxis."
10819053|NCT00043979|OG000|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
10819054|NCT00043979|OG000|Outcome|Recipients -Cyclosporine GVHD Prophylaxis|
10819055|NCT00043979|OG001|Outcome|Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis|
10819056|NCT00043979|EG000|Reported Event|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
10819057|NCT00044005|BG000|Baseline|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
10819058|NCT00044005|BG001|Baseline|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
10819059|NCT00044005|BG002|Baseline|Lurasidone 80mg|Lurasidone 80mg oral tablets
11207609|NCT02244580|OG000|Outcome|DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
10819060|NCT00044005|BG003|Baseline|Total|Total of all reporting groups
10819061|NCT00044005|FG000|Participant Flow|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
10819062|NCT00044005|FG001|Participant Flow|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
10819063|NCT00044005|FG002|Participant Flow|Lurasidone 80mg|Lurasidone 80mg oral tablets
10819064|NCT00044005|OG000|Outcome|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
10819065|NCT00044005|OG001|Outcome|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
10819066|NCT00044005|OG002|Outcome|Lurasidone 80mg|Lurasidone 80mg oral tablets
10819067|NCT00044005|EG000|Reported Event|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
10819068|NCT00044005|EG001|Reported Event|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
10819069|NCT00044005|EG002|Reported Event|Lurasidone 80mg|Lurasidone 80mg oral tablets
10819070|NCT00044044|BG000|Baseline|20 mg|Lurasidone 20 mg oral tablet taken once a day
10819071|NCT00044044|BG001|Baseline|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
10819072|NCT00044044|BG002|Baseline|80 mg|Lurasidone 80 mg oral tablet taken once a day
10819073|NCT00044044|BG003|Baseline|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
10819074|NCT00044044|BG004|Baseline|Placebo|Oral Capsule matching treatment group taken oce a day
10819075|NCT00044044|BG005|Baseline|Total|Total of all reporting groups
10819076|NCT00044044|FG000|Participant Flow|20 mg|Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
10819077|NCT00044044|FG001|Participant Flow|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
10819078|NCT00044044|FG002|Participant Flow|80 mg|Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
11207610|NCT02244580|OG001|Outcome|OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
10819079|NCT00044044|FG003|Participant Flow|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
10819080|NCT00044044|FG004|Participant Flow|Placebo|Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
10819081|NCT00044044|OG000|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
10819082|NCT00044044|OG001|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
10819083|NCT00044044|OG002|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
10819084|NCT00044044|OG003|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
10819085|NCT00044044|OG004|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
10819086|NCT00044044|EG000|Reported Event|20 mg|Lurasidone 20 mg oral tablet taken once a day
10819087|NCT00044044|EG001|Reported Event|40 mg|Lurasidone 40 mg oral tablet taken once a day
10819088|NCT00044044|EG002|Reported Event|80 mg|Lurasidone 80 mg oral tablet taken once a day
10819089|NCT00044044|EG003|Reported Event|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
10819090|NCT00044044|EG004|Reported Event|Placebo|Oral Capsule matching treatment group taken oce a day
10819091|NCT00044083|BG000|Baseline|Healthy Volunteers|Tolcapone 200 mg 1 week:Wash Out 1 week:Placebo 1 week: (or vice versa)
10819092|NCT00044083|BG001|Baseline|Patients|Tolcapone 200 mg 1 week:Wash Out 1 week:Placebo 1 week: (or vice versa)
10819093|NCT00044083|BG002|Baseline|Total|Total of all reporting groups
10819094|NCT00044083|FG000|Participant Flow|Placebo First Then Tolcapone|"Placebo one week first:~Tolcapone 200 mg second:"
10819095|NCT00044083|FG001|Participant Flow|Tolcapone First, Then Placebo|"Tolcapone one week:~Placebo one week second:"
10819096|NCT00044083|OG000|Outcome|Healthy Volunteer on Placebo|Placebo Days 1-7, Healthy voluntee
10819097|NCT00044083|OG001|Outcome|Healthy Volunteer Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid
10819098|NCT00044083|OG002|Outcome|Patient on Placebo|Placebo Days 1-7, Patient
10819099|NCT00044083|OG003|Outcome|Patients on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid
10819100|NCT00044083|OG000|Outcome|Healthy Volunteer on Placebo|Placebo Days 1-7, Healthy Voluntreers
10819101|NCT00044083|OG001|Outcome|Patient on Placebo|Placebo Days 1-7, Patients
10819102|NCT00044083|OG000|Outcome|Healthy Volunteers on Placebo|Placebo Days 1-7, Healthy Volunteers
10819103|NCT00044083|OG001|Outcome|Healthy Volunteers on Tolcapone|Tolcapone 100 mg TID on Day 1, 200 mg TID Days 2-7.
10819104|NCT00044083|OG002|Outcome|Patients on Placebo|Placebo Days 1-7, Patients
10819105|NCT00044083|OG003|Outcome|Patients on Tolcapone|Tolcapone 100 mg TID on Day 1, 200 mg TID Days 2-7
10819106|NCT00044083|OG000|Outcome|Patients on Placebo|Placebo Days 1-7, Patients
10819107|NCT00044083|OG001|Outcome|Patients on Tolcapone|Day 1 Tolcapone 100 mg tid, days 2-7 Tolcapone 200 mg tid, Patients
10819108|NCT00044083|OG000|Outcome|Healthy Volunteer on Placebo|Placebo Days 1-7, Healthy Volunteer
10819109|NCT00044083|OG001|Outcome|Healthy Volunteer on Tolcapone|Day 1 Tolcapone 100 mg tid, days 2-7 Tolcapone 200 mg tid
10819110|NCT00044083|OG000|Outcome|Healthy Volunteer COMT Val/Val Genotype on Placebo|Placebo Days 1-7, Healthy Volunteer COMT Val/Val Genotype
10819111|NCT00044083|OG001|Outcome|Healthy Volunteer COMT Val/Met Genotype on Placebo|Placebo Days 1-7, Healthy Volunteer COMT Val/Met Genotype
10819112|NCT00044083|OG002|Outcome|Healthy Volunteers COMT Met/Met Genotype on Placebo|Placebo Days 1-7, Healthy Volunteers COMT Met/Met Genotype
10819113|NCT00044083|OG003|Outcome|Healthy Volunteer COMT Val/Val Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid Healthy Volunteer COMT Val/Val Genotype
10819114|NCT00044083|OG004|Outcome|Healthy Volunteer COMT Val/Met Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid Healthy Volunteer COMT Val/Met Genotype
10819115|NCT00044083|OG005|Outcome|Healthy Volunteer COMT Met/Met Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid Healthy Volunteer COMT Met/Met Genotype
10819116|NCT00044083|OG000|Outcome|Patients COMT Val/Val Genotype on Placebo|Placebo Days 1-7, Patients COMT Val/Val Genotype
10819117|NCT00044083|OG001|Outcome|Patients COMT Val/Met Genotype on Placebo|Placebo Days 1-7, Patients COMT Val/Met Genotype
10819118|NCT00044083|OG002|Outcome|Patients COMT Met/Met Genotype on Placebo|Placebo Days 1-7, Patients COMT Met/Met Genotype
10819119|NCT00044083|OG003|Outcome|Patients COMT Val/Val Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid
10819120|NCT00044083|OG004|Outcome|Patients COMT Val/Met Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid
10819121|NCT00044083|OG005|Outcome|Patients COMT Met/Met Genotype on Tolcapone|Day 1: Tolcapone 100 mg tid, Days 2-7: Tolcapone 200 mg tid
10819122|NCT00044083|OG000|Outcome|Healthy Volunteer on Placebo|Placebo Days 1-7, Healthy volunteer
10819123|NCT00044083|EG000|Reported Event|Healthy Volunteers on Placebo|Placebo Days 1-7, Healthy Volunteers
10819124|NCT00044083|EG001|Reported Event|Healthy Volunteers on Tolcapone|Tolcapone 100 mg TID on Day 1, 200 mg TID Days 2-7.
10819125|NCT00044083|EG002|Reported Event|Patients on Placebo|Placebo Days 1-7, Patients
10819126|NCT00044083|EG003|Reported Event|Patients on Tolcapone|Tolcapone 100 mg TID on Day 1, 200 mg TID Days 2-7
10819127|NCT00044213|BG000|Baseline|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
10819128|NCT00044213|BG001|Baseline|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
10819129|NCT00044213|BG002|Baseline|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
10819130|NCT00044213|BG003|Baseline|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
10819131|NCT00044213|BG004|Baseline|Total|Total of all reporting groups
10819132|NCT00044213|FG000|Participant Flow|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
10819133|NCT00044213|FG001|Participant Flow|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
10819134|NCT00044213|FG002|Participant Flow|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
10819135|NCT00044213|FG003|Participant Flow|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
10819136|NCT00044213|OG000|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
10819137|NCT00044213|OG001|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
10819138|NCT00044213|OG002|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
10819139|NCT00044213|OG003|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
10819140|NCT00044213|EG000|Reported Event|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
10819141|NCT00044213|EG001|Reported Event|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
10819142|NCT00044213|EG002|Reported Event|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
10819143|NCT00044213|EG003|Reported Event|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
10819144|NCT00044512|BG000|Baseline|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
10819145|NCT00044512|FG000|Participant Flow|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
10819146|NCT00044512|OG000|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
10819147|NCT00044512|EG000|Reported Event|Sorafenib 400 mg b.i.d.|"Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d.Other AE section includes SAEs"
10819148|NCT00044655|BG000|Baseline|Stay|Participants will continue taking medication prescribed at study entry
10819149|NCT00044655|BG001|Baseline|Switch|Participants will change medications from medication prescribed at study entry
10819150|NCT00044655|BG002|Baseline|Total|Total of all reporting groups
10819151|NCT00044655|FG000|Participant Flow|Stay|Participants will continue taking medication prescribed at study entry
10819152|NCT00044655|FG001|Participant Flow|Switch|Participants will change medications from medication prescribed at study entry
10819153|NCT00044655|OG000|Outcome|Stay|Participants will continue taking medication prescribed at study entry
10819154|NCT00044655|OG001|Outcome|Switch|Participants will change medications from medication prescribed at study entry
10819155|NCT00044655|EG000|Reported Event|Stay|Participants will continue taking medication prescribed at study entry
10819156|NCT00044655|EG001|Reported Event|Switch|Participants will change medications from medication prescribed at study entry
10819157|NCT00045032|BG000|Baseline|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
10819158|NCT00045032|BG001|Baseline|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819159|NCT00045032|BG002|Baseline|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819160|NCT00045032|BG003|Baseline|Total|Total of all reporting groups
10819161|NCT00045032|FG000|Participant Flow|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
10819162|NCT00045032|FG001|Participant Flow|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819163|NCT00045032|FG002|Participant Flow|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819164|NCT00045032|OG000|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
11207611|NCT02244580|EG000|Reported Event||Since only tumor material was used, adverse events were not documented within the MammaTyper Study
10819165|NCT00045032|OG001|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819166|NCT00045032|OG001|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819167|NCT00045032|OG002|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819168|NCT00045032|OG000|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819169|NCT00045032|EG000|Reported Event|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.
10819170|NCT00045032|EG001|Reported Event|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819171|NCT00045032|EG002|Reported Event|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
10819172|NCT00045110|BG000|Baseline|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
10819173|NCT00045110|BG001|Baseline|Phase 2 w/ Recurrent Malignant Glioma|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib at a predetermined dose (150mg/day).~Patients requiring surgery were treated 7 days prior to tumor removal PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
10819174|NCT00045110|BG002|Baseline|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
10819175|NCT00045110|BG003|Baseline|Total|Total of all reporting groups
10819176|NCT00045110|FG000|Participant Flow|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
10819177|NCT00045110|FG001|Participant Flow|Phase 2 - Recurrent Malignant Glioma|"Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose.~Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
10819178|NCT00045110|FG002|Participant Flow|Phase 2 - Newly Diagnosed GBM Post RT|Patients with GBM with newly diagnosed disease following Radiation (RT) started erlotinib no more than 6 weeks from the completion of RT. Temozolomide or other adjuvant chemotherapy not allowed while on erotinib
10848002|NCT00287469|OG000|Outcome|20mcg Recombinant HEV|"20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)"
10819179|NCT00045110|OG000|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs ) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
10819180|NCT00045110|OG000|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
10819181|NCT00045110|OG000|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10819182|NCT00045110|OG000|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs (on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis..~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10819183|NCT00045110|OG000|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
10819184|NCT00045110|OG000|Outcome|Phase 2 Recurrent Malignant Gliomas and Stable Disease Post RT|"Patients with recurrent malignant gliomas not concurrently receiving EIAEDs treated with erlotinib at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
10819185|NCT00045110|OG000|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
10819186|NCT00045110|OG001|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819187|NCT00045110|OG002|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819188|NCT00045110|OG003|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819189|NCT00045110|OG004|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819190|NCT00045110|OG005|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819191|NCT00045110|OG006|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
10819192|NCT00045110|EG000|Reported Event|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
10848003|NCT00287469|OG001|Outcome|Placebo|"PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum"
10969203|NCT00904982|FG001|Participant Flow|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
10969204|NCT00904982|FG002|Participant Flow|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
10969205|NCT00904982|FG003|Participant Flow|4 Combined Group/Lottery and Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an"
10969206|NCT00904982|OG000|Outcome|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
10969207|NCT00904982|OG001|Outcome|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
10969208|NCT00904982|OG002|Outcome|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
10969209|NCT00904982|OG003|Outcome|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
11092556|NCT01540513|EG000|Reported Event|I124-NM404 Brain Metastases or GBM Imaging|"Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.~Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days."
11092557|NCT01540565|BG000|Baseline|Treatment (Veliparib)|"Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Veliparib: Given PO"
10819193|NCT00045110|EG001|Reported Event|Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
10819194|NCT00045162|BG000|Baseline|Cisplatin + Irinotecan|
10819195|NCT00045162|BG001|Baseline|Cisplatin + Etoposide|
10819196|NCT00045162|BG002|Baseline|Total|Total of all reporting groups
10819197|NCT00045162|FG000|Participant Flow|Cisplatin + Irinotecan|
10819198|NCT00045162|FG001|Participant Flow|Cisplatin + Etoposide|
10819199|NCT00045162|OG000|Outcome|Cisplatin + Irinotecan|
10819200|NCT00045162|OG001|Outcome|Cisplatin + Etoposide|
10819201|NCT00045162|EG000|Reported Event|Cisplatin + Irinotecan|
10819202|NCT00045162|EG001|Reported Event|Cisplatin + Etoposide|
10819203|NCT00045305|BG000|Baseline|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
10819204|NCT00045305|FG000|Participant Flow|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
10819205|NCT00045305|OG000|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
10819206|NCT00045305|EG000|Reported Event|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
10819207|NCT00045435|BG000|Baseline|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
10819208|NCT00045435|FG000|Participant Flow|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
10819209|NCT00045435|OG000|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
10848004|NCT00287469|OG000|Outcome|Placebo|"PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum"
11244386|NCT02510664|EG002|Reported Event|Provider|"There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.~Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
11286193|NCT02885025|EG000|Reported Event|BSE + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~no adverse events reported fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis."
11286194|NCT02885025|EG001|Reported Event|BSE + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
11286195|NCT02885025|EG002|Reported Event|Placebo Pill + Nasal Fluticasone|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE."
10819210|NCT00045435|EG000|Reported Event|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
10819211|NCT00045487|BG000|Baseline|OSI-774|Once-daily oral administration for 4 weeks.
10819212|NCT00045487|FG000|Participant Flow|OSI-774|OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
10819213|NCT00045487|OG000|Outcome|OSI-774|Once-daily oral administration for 4 weeks.
10819214|NCT00045487|EG000|Reported Event|OSI-774|Once-daily oral administration for 4 weeks.
10819215|NCT00045630|BG000|Baseline|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
10819216|NCT00045630|FG000|Participant Flow|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
10819217|NCT00045630|OG000|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
11286196|NCT02885025|EG003|Reported Event|Placebo Pill + Normal Saline Nasal Spray|"subjects will be randomized into 1 of 4 arms:~BSE + Nasal Fluticasone~BSE + normal saline nasal spray~Placebo Pill + Nasal Fluticasone~Placebo Pill + normal saline nasal spray~broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.~normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study"
10819218|NCT00045630|EG000|Reported Event|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
10819219|NCT00045708|BG000|Baseline|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
10819220|NCT00045708|BG001|Baseline|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819221|NCT00045708|BG002|Baseline|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
10819222|NCT00045708|BG003|Baseline|Total|Total of all reporting groups
10848005|NCT00287469|OG001|Outcome|20mcg Recombinant HEV|"20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)"
10848006|NCT00287469|EG000|Reported Event|Placebo|"PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum"
11207612|NCT02244619|BG000|Baseline|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
11207613|NCT02244619|BG001|Baseline|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
11207614|NCT02244619|BG002|Baseline|Total|Total of all reporting groups
11207615|NCT02244619|FG000|Participant Flow|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
11207616|NCT02244619|FG001|Participant Flow|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
11207617|NCT02244619|OG000|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
11207618|NCT02244619|OG001|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
11207619|NCT02244619|EG000|Reported Event|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.~Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
11207620|NCT02244619|EG001|Reported Event|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.~IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
11207621|NCT02244840|BG000|Baseline|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
11207622|NCT02244840|FG000|Participant Flow|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
11207623|NCT02244840|OG000|Outcome|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
11207624|NCT02244840|EG000|Reported Event|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
11207625|NCT02244918|BG000|Baseline|Counseling Plus Nicotine Replacement Therapy|"Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.~Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge."
11207626|NCT02244918|BG001|Baseline|Counseling|Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
11207627|NCT02244918|BG002|Baseline|Total|Total of all reporting groups
11207628|NCT02244918|FG000|Participant Flow|Counseling Plus Nicotine Replacement Therapy|"Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.~Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge."
11207629|NCT02244918|FG001|Participant Flow|Counseling|Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
11207630|NCT02244918|OG000|Outcome|Counseling Plus Nicotine Replacement Therapy|"Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.~Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge."
11207631|NCT02244918|OG001|Outcome|Counseling|Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
11207632|NCT02244918|OG000|Outcome|Counseling Plus Nicotine Replacement Therapy|"Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.~Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge."
11207633|NCT02244918|EG000|Reported Event|Counseling Plus Nicotine Replacement Therapy|"Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.~Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge."
11207634|NCT02244918|EG001|Reported Event|Counseling|Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
11207635|NCT02244957|BG000|Baseline|Chronic Obstructive Pulmonary Disease (COPD)|Subjects with only Chronic Obstructive Pulmonary Disease (COPD).
11207636|NCT02244957|BG001|Baseline|Overlap Syndrome|Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
11207637|NCT02244957|BG002|Baseline|Total|Total of all reporting groups
11207638|NCT02244957|FG000|Participant Flow|Chronic Obstructive Pulmonary Disease (COPD)|Subjects with only Chronic Obstructive Pulmonary Disease (COPD)
11207639|NCT02244957|FG001|Participant Flow|Overlap Syndrome|Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
11207640|NCT02244957|OG000|Outcome|Chronic Obstructive Pulmonary Disease (COPD)|Subjects with only Chronic Obstructive Pulmonary Disease (COPD).
11207641|NCT02244957|OG001|Outcome|Overlap Syndrome|Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
11207642|NCT02244957|OG000|Outcome|Bi-level Positive Airway Pressure (BPAP)|"Bi-level positive airway pressure (BPAP)~Bi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations <88% while on stable bi-level settings."
11207643|NCT02244957|OG001|Outcome|Nocturnal Oxygen|"Nocturnal oxygen~Nocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months."
11207644|NCT02244957|EG000|Reported Event|Chronic Obstructive Pulmonary Disease (COPD)|Subjects with only Chronic Obstructive Pulmonary Disease (COPD)
11207645|NCT02244957|EG001|Reported Event|Overlap Syndrome|Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
11207646|NCT02244996|BG000|Baseline|Lycium Barbarum|"Daily Lycium Barbarum dosage: 10g of granules for 12 months~Lycium Barbarum: Traditional Chinese Herbs"
11207647|NCT02244996|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11207648|NCT02244996|BG002|Baseline|Total|Total of all reporting groups
11207649|NCT02244996|FG000|Participant Flow|Lycium Barbarum|"Daily Lycium Barbarum dosage: 10g of granules for 12 months~Lycium Barbarum: Traditional Chinese Herbs"
11207650|NCT02244996|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11207651|NCT02244996|OG000|Outcome|Lycium Barbarum|"Daily Lycium Barbarum dosage: 10g of granules for 12 months~Lycium Barbarum: Traditional Chinese Herbs"
11207652|NCT02244996|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11207653|NCT02244996|EG000|Reported Event|Lycium Barbarum|"Daily Lycium Barbarum dosage: 10g of granules for 12 months~Lycium Barbarum: Traditional Chinese Herbs"
11207654|NCT02244996|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11207655|NCT02245217|BG000|Baseline|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
11207656|NCT02245217|FG000|Participant Flow|PET/CT Imaging Arm|Positron Emission Tomography (PET)/CT scan to assess treatment efficacy
11207657|NCT02245217|OG000|Outcome|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
11207658|NCT02245217|EG000|Reported Event|PET/CT Imaging Arm|PET/CT scan to assess treatment efficacy
11207659|NCT02245360|BG000|Baseline|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
11207660|NCT02245360|BG001|Baseline|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
11207661|NCT02245360|BG002|Baseline|Total|Total of all reporting groups
11207662|NCT02245360|FG000|Participant Flow|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
11207663|NCT02245360|FG001|Participant Flow|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
11207664|NCT02245360|OG000|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
11207665|NCT02245360|OG001|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
10969210|NCT00904982|EG000|Reported Event|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
10969211|NCT00904982|EG001|Reported Event|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
11207666|NCT02245360|EG000|Reported Event|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
11207667|NCT02245360|EG001|Reported Event|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
11207668|NCT02245412|BG000|Baseline|ALXN1007 10 mg/kg Once Weekly|Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.
11207669|NCT02245412|BG001|Baseline|ALXN1007 20 mg/kg Once Weekly|Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207670|NCT02245412|BG002|Baseline|ALXN1007 20 mg/kg Twice Weekly|Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207671|NCT02245412|BG003|Baseline|Total|Total of all reporting groups
11207672|NCT02245412|FG000|Participant Flow|ALXN1007 10 mg/kg Once Weekly|Cohort 1, the first dosing cohort, received 10 milligrams/kilogram (mg/kg) ALXN1007 intravenously (IV) once weekly for 8 weeks.
11207673|NCT02245412|FG001|Participant Flow|ALXN1007 20 mg/kg Once Weekly|Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207674|NCT02245412|FG002|Participant Flow|ALXN1007 20 mg/kg Twice Weekly|Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207675|NCT02245412|OG000|Outcome|ALXN1007 10 mg/kg Once Weekly|Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.
11207676|NCT02245412|OG001|Outcome|ALXN1007 20 mg/kg Once Weekly|Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11286197|NCT02885181|BG000|Baseline|GS-9876 30 mg|GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11092558|NCT01540565|FG000|Participant Flow|Treatment (Veliparib)|"Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Veliparib: Given PO"
11092559|NCT01540565|OG000|Outcome|Treatment (Veliparib)|"Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Veliparib: Given PO"
11092560|NCT01540565|EG000|Reported Event|Treatment (Veliparib)|"Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Veliparib: Given PO"
11092561|NCT01540773|BG000|Baseline|All Study Participants|Crossover of amino acid supplement to placebo or placebo to amino acid supplement
11092562|NCT01540773|FG000|Participant Flow|Amino Acid Supplement, Then Placebo|50% of participants first received an orally administered supplement with the proprietary amino acid derivative blend. After a washout period of one week, they then received a Placebo tablet (matching the amino acid supplement).
11092563|NCT01540773|FG001|Participant Flow|Placebo, Then Amino Acid Supplement|50% of participants first received an orally administered Placebo tablet (matching the amino acid supplement). After a washout period of one week, they then received the orally administered supplement with the proprietary amino acid derivative blend.
11092564|NCT01540773|OG000|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative~A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
11092565|NCT01540773|OG001|Outcome|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
11092566|NCT01540773|OG000|Outcome|Amino Acid Supplement|Participants received an orally administered supplement with the proprietary amino acid derivative blend.
11092567|NCT01540773|OG001|Outcome|Placebo|Participants received an orally administered Placebo tablet (matching the amino acid supplement).
11092568|NCT01540773|EG000|Reported Event|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
11092569|NCT01540773|EG001|Reported Event|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
11092570|NCT01540825|BG000|Baseline|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
11092571|NCT01540825|BG001|Baseline|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
11092572|NCT01540825|BG002|Baseline|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
11092573|NCT01540825|BG003|Baseline|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
11092574|NCT01540825|BG004|Baseline|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
11092575|NCT01540825|BG005|Baseline|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
11092576|NCT01540825|BG006|Baseline|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
11092577|NCT01540825|BG007|Baseline|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
11092578|NCT01540825|BG008|Baseline|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
11092579|NCT01540825|BG009|Baseline|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
11092580|NCT01540825|BG010|Baseline|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
11092581|NCT01540825|BG011|Baseline|Total|Total of all reporting groups
11092582|NCT01540825|FG000|Participant Flow|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
11092583|NCT01540825|FG001|Participant Flow|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
11092584|NCT01540825|FG002|Participant Flow|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
11092585|NCT01540825|FG003|Participant Flow|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
11092586|NCT01540825|FG004|Participant Flow|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
11092587|NCT01540825|FG005|Participant Flow|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
11092588|NCT01540825|FG006|Participant Flow|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
11092589|NCT01540825|FG007|Participant Flow|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
11092590|NCT01540825|FG008|Participant Flow|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
11092591|NCT01540825|FG009|Participant Flow|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
11092592|NCT01540825|FG010|Participant Flow|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
11092593|NCT01540825|OG000|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
11092594|NCT01540825|OG001|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
11092595|NCT01540825|OG002|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
11092596|NCT01540825|OG003|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
11092597|NCT01540825|OG004|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
11092598|NCT01540825|OG005|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
11092599|NCT01540825|OG006|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
11244387|NCT02510794|BG000|Baseline|Port Delivery System With Ranibizumab 10mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11092600|NCT01540825|OG007|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
11092601|NCT01540825|OG008|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
11092602|NCT01540825|OG009|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
11092603|NCT01540825|OG010|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
11092604|NCT01540825|OG000|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
11092605|NCT01540825|OG001|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
11092606|NCT01540825|OG002|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
11092607|NCT01540825|OG003|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
11092608|NCT01540825|OG004|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
11092609|NCT01540825|OG005|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
11092610|NCT01540825|OG006|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
11092611|NCT01540825|OG007|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
11092612|NCT01540825|OG008|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
11092613|NCT01540825|OG009|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
11092614|NCT01540825|EG000|Reported Event|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
11092615|NCT01540825|EG001|Reported Event|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
11092616|NCT01540825|EG002|Reported Event|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
11092617|NCT01540825|EG003|Reported Event|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
11092618|NCT01540825|EG004|Reported Event|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
11092619|NCT01540825|EG005|Reported Event|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
11092620|NCT01540825|EG006|Reported Event|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
11092621|NCT01540825|EG007|Reported Event|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
11092622|NCT01540825|EG008|Reported Event|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
11092623|NCT01540825|EG009|Reported Event|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
11092624|NCT01540825|EG010|Reported Event|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
11092625|NCT01540838|BG000|Baseline|Infusion With Paracetamol|"Cefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)~Infusion with paracetamol: The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days."
11092626|NCT01540838|BG001|Baseline|Bolus With Placebo|"Cefotaxime is administered as bolus q.i.d. with a placebo of paracetamol~Bolus without paracetamol: The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days."
11092627|NCT01540838|BG002|Baseline|Total|Total of all reporting groups
11092628|NCT01540838|FG000|Participant Flow|Infusion With Paracetamol|"Cefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)~Infusion with paracetamol: The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days."
11092629|NCT01540838|FG001|Participant Flow|Bolus With Placebo|"Cefotaxime is administered as bolus q.i.d. with a placebo of paracetamol~Bolus without paracetamol: The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days."
11092630|NCT01540838|OG000|Outcome|Infusion With Paracetamol|"Cefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)~Infusion with paracetamol: The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days."
11092631|NCT01540838|OG001|Outcome|Bolus With Placebo|"Cefotaxime is administered as bolus q.i.d. with a placebo of paracetamol~Bolus without paracetamol: The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days."
11092632|NCT01540838|EG000|Reported Event|Infusion With Paracetamol|"Cefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)~Infusion with paracetamol: The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days."
11207677|NCT02245412|OG002|Outcome|ALXN1007 20 mg/kg Twice Weekly|Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207678|NCT02245412|EG000|Reported Event|ALXN1007 10 mg/kg Once Weekly|Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.
11207679|NCT02245412|EG001|Reported Event|ALXN1007 20 mg/kg Once Weekly|Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207680|NCT02245412|EG002|Reported Event|ALXN1007 20 mg/kg Twice Weekly|Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
11207681|NCT02245516|BG000|Baseline|KPI-121 1.0% Ophthalmic Suspension|"KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 1.0% Ophthalmic Suspension: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207682|NCT02245516|BG001|Baseline|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 0.25% Ophthalmic Suspension: KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207683|NCT02245516|BG002|Baseline|Total|Total of all reporting groups
11207684|NCT02245516|FG000|Participant Flow|KPI-121 1.0% Ophthalmic Suspension|"KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 1.0% Ophthalmic Suspension: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207685|NCT02245516|FG001|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 0.25% Ophthalmic Suspension: KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207686|NCT02245516|OG000|Outcome|KPI-121 1.0% Ophthalmic Suspension|"KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 1.0% Ophthalmic Suspension: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207687|NCT02245516|OG001|Outcome|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 0.25% Ophthalmic Suspension: KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207688|NCT02245516|EG000|Reported Event|KPI-121 1.0% Ophthalmic Suspension|"KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 1.0% Ophthalmic Suspension: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207689|NCT02245516|EG001|Reported Event|KPI-121 0.25% Ophthalmic Suspension|"KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema~KPI-121 0.25% Ophthalmic Suspension: KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate."
11207690|NCT02245568|BG000|Baseline|LMTM 100-300 mg/Day|The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
11207691|NCT02245568|FG000|Participant Flow|LMTM 100-300 mg/Day|The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
10848007|NCT00287469|EG001|Reported Event|20mcg Recombinant HEV|"20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)"
11207692|NCT02245568|OG000|Outcome|LMTM 100-300 mg/Day|The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
11207693|NCT02245568|EG000|Reported Event|LMTM 100-300 mg/Day|The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
11207694|NCT02245620|BG000|Baseline|MTP-131 (Bendavia™)|MTP-131 (Bendavia™) administered as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.
11207695|NCT02245620|BG001|Baseline|Placebo|Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
11207696|NCT02245620|BG002|Baseline|Total|Total of all reporting groups
11207697|NCT02245620|FG000|Participant Flow|Elamipretide|Elamipretide administered as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.
11207698|NCT02245620|FG001|Participant Flow|Placebo|Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
11207699|NCT02245620|OG000|Outcome|MTP-131 (Bendavia™)|MTP-131 (Bendavia™) administered as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.
11207700|NCT02245620|OG001|Outcome|Placebo|Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
11207701|NCT02245620|EG000|Reported Event|Elamipretide|"Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.~Elamipretide: Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours"
11207702|NCT02245620|EG001|Reported Event|Placebo|"Placebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours.~Placebo: Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours"
11207703|NCT02245737|BG000|Baseline|Placebo|Participants received placebo film-coated oral tablets once daily.
11207704|NCT02245737|BG001|Baseline|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11207705|NCT02245737|BG002|Baseline|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11207706|NCT02245737|BG003|Baseline|Total|Total of all reporting groups
11207707|NCT02245737|FG000|Participant Flow|Placebo|Participants received placebo film-coated oral tablets once daily.
11207708|NCT02245737|FG001|Participant Flow|Lanabecestat 20 Milligrams (mg)|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11207709|NCT02245737|FG002|Participant Flow|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11207710|NCT02245737|OG000|Outcome|Placebo|Participants received placebo film-coated oral tablets once daily.
11207711|NCT02245737|OG001|Outcome|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11207712|NCT02245737|OG002|Outcome|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11207713|NCT02245737|OG000|Outcome|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11207714|NCT02245737|OG001|Outcome|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11207715|NCT02245737|EG000|Reported Event|Placebo|Participants received placebo film-coated oral tablets once daily.
11207716|NCT02245737|EG001|Reported Event|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11207717|NCT02245737|EG002|Reported Event|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11207718|NCT02245815|BG000|Baseline|Use Probiotics Boucardii|"group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Boucardii: group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
11207719|NCT02245815|BG001|Baseline|Use Probiotics Multi-species|"Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
11207720|NCT02245815|BG002|Baseline|Total|Total of all reporting groups
11207721|NCT02245815|FG000|Participant Flow|Use Probiotics Boucardii|"group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Boucardii: group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
11207722|NCT02245815|FG001|Participant Flow|Use Probiotics Multi-species|"Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
10969212|NCT00904982|EG002|Reported Event|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
10969213|NCT00904982|EG003|Reported Event|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
10969214|NCT00904995|BG000|Baseline|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
10969215|NCT00904995|BG001|Baseline|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
10969216|NCT00904995|BG002|Baseline|Total|Total of all reporting groups
10969217|NCT00904995|FG000|Participant Flow|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
10969218|NCT00904995|FG001|Participant Flow|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
10969219|NCT00904995|OG000|Outcome|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
10969220|NCT00904995|OG001|Outcome|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
10969221|NCT00904995|EG000|Reported Event|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
10969222|NCT00904995|EG001|Reported Event|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
10969223|NCT00905021|BG000|Baseline|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
10969224|NCT00905021|FG000|Participant Flow|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
10969225|NCT00905021|OG000|Outcome|Exemestane Plus Sunitinib|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
10969226|NCT00905021|OG000|Outcome|Exemestane Plus Sunitinib|This is a single arm study. All patients received Exemestane 25mg per day and Sunitinib 37.5 mg per day.
10969227|NCT00905021|EG000|Reported Event|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
10969228|NCT00905034|BG000|Baseline|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
10969229|NCT00905034|FG000|Participant Flow|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
10969230|NCT00905034|OG000|Outcome|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
10969231|NCT00905034|EG000|Reported Event|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
10970624|NCT00911300|OG001|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
11092633|NCT01540838|EG001|Reported Event|Bolus With Placebo|"Cefotaxime is administered as bolus q.i.d. with a placebo of paracetamol~Bolus without paracetamol: The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days."
11092634|NCT01540851|BG000|Baseline|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092635|NCT01540851|BG001|Baseline|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092636|NCT01540851|BG002|Baseline|Total|Total of all reporting groups
11092637|NCT01540851|FG000|Participant Flow|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092638|NCT01540851|FG001|Participant Flow|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092639|NCT01540851|OG000|Outcome|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092640|NCT01540851|OG001|Outcome|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092641|NCT01540851|OG000|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
11092642|NCT01540851|OG001|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
11092643|NCT01540851|EG000|Reported Event|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092644|NCT01540851|EG001|Reported Event|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
11092645|NCT01540981|BG000|Baseline|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
11092646|NCT01540981|BG001|Baseline|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
11092647|NCT01540981|BG002|Baseline|Total|Total of all reporting groups
11092648|NCT01540981|FG000|Participant Flow|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
11092649|NCT01540981|FG001|Participant Flow|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
11092650|NCT01540981|OG000|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
11092651|NCT01540981|OG001|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
11092652|NCT01540981|EG000|Reported Event|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
11092653|NCT01540981|EG001|Reported Event|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
11207723|NCT02245815|OG000|Outcome|Probiotics Lactobacillus Acidophilus Boucardii|group A will be administered the Lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
11207724|NCT02245815|OG001|Outcome|Use Probiotics Multi-species|Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
11207725|NCT02245815|OG000|Outcome|Probiotics Lactobacillus Acidophilus Boucardii|Group A will be administered the Lactobacillus acidophilus boucardii probiotic
11207726|NCT02245815|OG001|Outcome|Use Probiotics Multi-species|Group B will be administered multi-species probiotics
11207727|NCT02245815|EG000|Reported Event|Use Probiotics Lactobacillus Acidophilus Boucardii|"group A will be administered the lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Lactobacillus acidophilus boucardii: group A will be administered the Lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
11207728|NCT02245815|EG001|Reported Event|Use Probiotics Multi-species|"Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).~use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment."
11207729|NCT02246010|BG000|Baseline|Lactose-free Milk|Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
11207730|NCT02246010|BG001|Baseline|Regular Infant Milk|Regular infant milk formula and anti-diarrheic diet for 7 days.
11207731|NCT02246010|BG002|Baseline|Total|Total of all reporting groups
11207732|NCT02246010|FG000|Participant Flow|Lactose-free Milk|"Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.~Lactose- free milk: Lactose- free milk"
11207733|NCT02246010|FG001|Participant Flow|Regular Infant Milk|Regular infant milk formula and anti-diarrheic diet for 7 days.
11207734|NCT02246010|OG000|Outcome|Lactose-free Milk|"Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.~Lactose- free milk: Lactose- free milk"
11207735|NCT02246010|OG001|Outcome|Regular Infant Milk|Regular infant milk formula and anti-diarrheic diet for 7 days.
11207736|NCT02246010|EG000|Reported Event|Lactose-free Milk|"Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.~Lactose- free milk: Lactose- free milk"
11207737|NCT02246010|EG001|Reported Event|Regular Infant Milk|Regular infant milk formula and anti-diarrheic diet for 7 days.
11207738|NCT02246062|BG000|Baseline|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
11207739|NCT02246062|BG001|Baseline|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
11207740|NCT02246062|BG002|Baseline|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
11207741|NCT02246062|BG003|Baseline|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
11207742|NCT02246062|BG004|Baseline|Total|Total of all reporting groups
11207743|NCT02246062|FG000|Participant Flow|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
11207744|NCT02246062|FG001|Participant Flow|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
11207745|NCT02246062|FG002|Participant Flow|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
11207746|NCT02246062|FG003|Participant Flow|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
11207747|NCT02246062|OG000|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
11207748|NCT02246062|OG001|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
11207749|NCT02246062|OG002|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
11286198|NCT02885181|BG001|Baseline|GS-9876 10 mg|GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11207750|NCT02246062|OG003|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
11207751|NCT02246062|EG000|Reported Event|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
11207752|NCT02246062|EG001|Reported Event|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
11207753|NCT02246062|EG002|Reported Event|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
11207754|NCT02246062|EG003|Reported Event|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
11207755|NCT02246166|BG000|Baseline|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
11207756|NCT02246166|BG001|Baseline|Placebo|Matching placebo tablet
11207757|NCT02246166|BG002|Baseline|Total|Total of all reporting groups
11207758|NCT02246166|FG000|Participant Flow|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
11207759|NCT02246166|FG001|Participant Flow|Placebo|Matching placebo tablet
11207760|NCT02246166|OG000|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
11207761|NCT02246166|OG001|Outcome|Placebo|Matching placebo tablet
11207762|NCT02246166|EG000|Reported Event|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
10819223|NCT00045708|FG000|Participant Flow|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819224|NCT00045708|FG001|Participant Flow|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819225|NCT00045708|FG002|Participant Flow|Group 3 - MTD Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
11207763|NCT02246166|EG001|Reported Event|Placebo|Matching placebo tablet
11207764|NCT02246218|BG000|Baseline|RAVICTI: Age 2 Months to < 2 Years|Participants age 2 months to < 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207765|NCT02246218|BG001|Baseline|RAVICTI: Age 0 to <2 Months|Participants age 0 to < 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207766|NCT02246218|BG002|Baseline|Total|Total of all reporting groups
11207767|NCT02246218|FG000|Participant Flow|RAVICTI: Age 2 Months to < 2 Years|Participants age 2 months to < 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207768|NCT02246218|FG001|Participant Flow|RAVICTI: Age 0 to < 2 Months|Participants age 0 to < 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207769|NCT02246218|OG000|Outcome|RAVICTI: Age 2 Months to < 2 Years|Participants age 2 months to < 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207770|NCT02246218|OG000|Outcome|RAVICTI: Age 0 to < 2 Months|Participants age 0 to < 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207771|NCT02246218|EG000|Reported Event|RAVICTI: Age 2 Months to < 2 Years|Participants age 2 months to < 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207772|NCT02246218|EG001|Reported Event|RAVICTI: Age 0 to <2 Months|Participants age 0 to < 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator.
11207773|NCT02246309|BG000|Baseline|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
11207774|NCT02246309|BG001|Baseline|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
11207775|NCT02246309|BG002|Baseline|Total|Total of all reporting groups
11207776|NCT02246309|FG000|Participant Flow|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
11207777|NCT02246309|FG001|Participant Flow|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
11207778|NCT02246309|OG000|Outcome|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
11207779|NCT02246309|OG001|Outcome|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
11207780|NCT02246309|EG000|Reported Event|Embryoscope Time Lapse System|"All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection."
11207781|NCT02246309|EG001|Reported Event|Standard Embryo Culture|"All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.~Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system."
11207782|NCT02246413|BG000|Baseline|RAINBOW Intervention Program|"An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.~RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care"
11207783|NCT02246413|BG001|Baseline|Usual Care|Usual Care.
11207784|NCT02246413|BG002|Baseline|Total|Total of all reporting groups
11207785|NCT02246413|FG000|Participant Flow|RAINBOW Intervention Program|"An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.~RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care"
11207786|NCT02246413|FG001|Participant Flow|Usual Care|Usual Care.
11207787|NCT02246413|OG000|Outcome|RAINBOW Intervention Program|"An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.~RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care"
11207788|NCT02246413|OG001|Outcome|Usual Care|Usual Care.
11207789|NCT02246413|EG000|Reported Event|RAINBOW Intervention Program|"An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.~RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care"
11207790|NCT02246413|EG001|Reported Event|Usual Care|Usual Care.
11207791|NCT02246439|BG000|Baseline|RHB-102|1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
11207792|NCT02246439|BG001|Baseline|Placebo|1 tablet of matching placebo, once daily for up to 4 days.
11207793|NCT02246439|BG002|Baseline|Total|Total of all reporting groups
11207794|NCT02246439|FG000|Participant Flow|RHB-102|1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
11207795|NCT02246439|FG001|Participant Flow|Placebo|1 tablet of matching placebo, once daily for up to 4 days.
11207796|NCT02246439|OG000|Outcome|RHB-102|1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
10819226|NCT00045708|OG000|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819227|NCT00045708|OG001|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819228|NCT00045708|OG002|Outcome|Group 3 - MTD (6.8mg/m2/Day) Phase 2|"Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~ixabepilone: Given IV~MTD for no anticonvulsant arm = 6.8mg/m2/day MTD for anticonvulsant arm = 9.6mg/m2/day~Only no anticonvulsant subjects at 6.8mg/m2/day treated in Phase 2"
10819229|NCT00045708|OG000|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819230|NCT00045708|OG001|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
11207797|NCT02246439|OG001|Outcome|Placebo Oral Tablet|1 tablet of matching placebo, once daily for up to 4 days.
11207798|NCT02246439|EG000|Reported Event|RHB-102|1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
11207799|NCT02246439|EG001|Reported Event|Placebo|1 tablet of matching placebo, once daily for up to 4 days.
11207800|NCT02246478|BG000|Baseline|Placebo|"Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207801|NCT02246478|BG001|Baseline|TAS-205 Low Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207802|NCT02246478|BG002|Baseline|TAS-205 Middle Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207803|NCT02246478|BG003|Baseline|TAS-205 High Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207804|NCT02246478|BG004|Baseline|Total|Total of all reporting groups
11207805|NCT02246478|FG000|Participant Flow|Placebo|"Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207806|NCT02246478|FG001|Participant Flow|TAS-205 Low Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207807|NCT02246478|FG002|Participant Flow|TAS-205 Middle Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207808|NCT02246478|FG003|Participant Flow|TAS-205 High Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207809|NCT02246478|OG000|Outcome|Placebo|"Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
10819231|NCT00045708|OG000|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
10850947|NCT03410992|OG001|Outcome|Bimekizumab 320 mg Q4W (RS)|Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.
11207810|NCT02246478|OG001|Outcome|TAS-205 Low Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207811|NCT02246478|OG002|Outcome|TAS-205 Middle Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207812|NCT02246478|OG003|Outcome|TAS-205 High Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207813|NCT02246478|OG000|Outcome|TAS-205 Low Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207814|NCT02246478|OG001|Outcome|TAS-205 Middle Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207815|NCT02246478|OG002|Outcome|TAS-205 High Dose|"TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals~・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
11207816|NCT02246478|EG000|Reported Event|Placebo, Single-dose Phase|Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
11207817|NCT02246478|EG001|Reported Event|TAS-205 Low Dose, Single-dose Phase|Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
10819232|NCT00045708|OG000|Outcome|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
10819233|NCT00045708|OG001|Outcome|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819234|NCT00045708|OG002|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
10819235|NCT00045708|OG000|Outcome|Group A [Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1"
10819236|NCT00045708|OG001|Outcome|Group B [No Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
11207818|NCT02246478|EG002|Reported Event|TAS-205 Middle Dose, Single-dose Phase|Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
11207819|NCT02246478|EG003|Reported Event|TAS-205 High Dose, Single-dose|Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
11207820|NCT02246478|EG004|Reported Event|Placebo, Multiple-dose Phase|Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
10819237|NCT00045708|OG000|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD (6.8mg/m2).
10819238|NCT00045708|EG000|Reported Event|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
10848008|NCT00287586|BG000|Baseline|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
11207821|NCT02246478|EG005|Reported Event|TAS-205 Low Dose, Multiple-dose Phase|Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
11207822|NCT02246478|EG006|Reported Event|TAS-205 Middle Dose, Multiple-dose Phase|Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
11207823|NCT02246478|EG007|Reported Event|TAS-205 High Dose, Multiple-dose Phase|Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
11207824|NCT02246582|BG000|Baseline|All Subjects|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
11207825|NCT02246582|FG000|Participant Flow|Group A (FST 30 Mins After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
11207826|NCT02246582|FG001|Participant Flow|Group B (FST 14 Hrs After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
11207827|NCT02246582|OG000|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
11207828|NCT02246582|EG000|Reported Event|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
11207829|NCT02246608|BG000|Baseline|NPWT Standard of Care|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.~Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT."
11207830|NCT02246608|BG001|Baseline|NPWT Standard of Care Plus Oasis Wound Product|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.~Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns."
10819239|NCT00045708|EG001|Reported Event|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
10819240|NCT00045708|EG002|Reported Event|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
10819241|NCT00045734|BG000|Baseline|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10819242|NCT00045734|FG000|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10819243|NCT00045734|OG000|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10819244|NCT00045734|EG000|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10819245|NCT00045942|BG000|Baseline|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819246|NCT00045942|BG001|Baseline|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10848009|NCT00287586|BG001|Baseline|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
10848010|NCT00287586|BG002|Baseline|Total|Total of all reporting groups
11207831|NCT02246608|BG002|Baseline|Total|Total of all reporting groups
10969232|NCT00905060|BG000|Baseline|Protein Peptide-Complex (HSPPC-96)|"Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.~HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide."
10969233|NCT00905060|FG000|Participant Flow|Protein Peptide-Complex (HSPPC-96)|"Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.~HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide."
10969234|NCT00905060|OG000|Outcome|Protein Peptide-Complex (HSPPC-96)|"Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.~HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide."
10969235|NCT00905060|EG000|Reported Event|Protein Peptide-Complex (HSPPC-96)|"Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.~HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide."
10969236|NCT00905125|BG000|Baseline|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
10969237|NCT00905125|BG001|Baseline|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
10969238|NCT00905125|BG002|Baseline|Total|Total of all reporting groups
11207832|NCT02246608|FG000|Participant Flow|NPWT Standard of Care|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.~Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT."
10969239|NCT00905125|FG000|Participant Flow|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
10969240|NCT00905125|FG001|Participant Flow|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
10969241|NCT00905125|OG000|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
10969242|NCT00905125|OG001|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
10969243|NCT00905125|EG000|Reported Event|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
11207833|NCT02246608|FG001|Participant Flow|NPWT Standard of Care Plus Oasis Wound Product|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.~Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns."
10969244|NCT00905125|EG001|Reported Event|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
10969245|NCT00905151|BG000|Baseline|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
10969246|NCT00905151|FG000|Participant Flow|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
10969247|NCT00905151|OG000|Outcome|HIV Positive|Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
11207834|NCT02246608|OG000|Outcome|NPWT Standard of Care|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.~Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT."
10969248|NCT00905151|EG000|Reported Event|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
10969249|NCT00905255|BG000|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10969250|NCT00905255|BG001|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
10969251|NCT00905255|BG002|Baseline|Total|Total of all reporting groups
10969252|NCT00905255|FG000|Participant Flow|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
10969253|NCT00905255|FG001|Participant Flow|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
10969254|NCT00905255|OG000|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
10969255|NCT00905255|OG000|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
11207835|NCT02246608|OG001|Outcome|NPWT Standard of Care Plus Oasis Wound Product|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.~Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns."
11207836|NCT02246608|EG000|Reported Event|NPWT Standard of Care|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.~Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT."
10819247|NCT00045942|BG002|Baseline|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819248|NCT00045942|BG003|Baseline|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819249|NCT00045942|BG004|Baseline|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819250|NCT00045942|BG005|Baseline|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819251|NCT00045942|BG006|Baseline|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819252|NCT00045942|BG007|Baseline|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819253|NCT00045942|BG008|Baseline|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819254|NCT00045942|BG009|Baseline|Total|Total of all reporting groups
10819255|NCT00045942|FG000|Participant Flow|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819256|NCT00045942|FG001|Participant Flow|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819257|NCT00045942|FG002|Participant Flow|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819258|NCT00045942|FG003|Participant Flow|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819259|NCT00045942|FG004|Participant Flow|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819260|NCT00045942|FG005|Participant Flow|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819261|NCT00045942|FG006|Participant Flow|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819262|NCT00045942|FG007|Participant Flow|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819263|NCT00045942|FG008|Participant Flow|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819264|NCT00045942|OG000|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819265|NCT00045942|OG000|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819266|NCT00045942|OG001|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10969256|NCT00905255|OG001|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
10969257|NCT00905255|EG000|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
10969258|NCT00905255|EG001|Reported Event|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
11207837|NCT02246608|EG001|Reported Event|NPWT Standard of Care Plus Oasis Wound Product|"Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.~Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns."
11207838|NCT02246647|BG000|Baseline|Healthy Volunteers|Healthy volunteers between ages 18 - 65, who have not history of IBS.
11207839|NCT02246647|BG001|Baseline|IBS-C|Volunteers who have been diagnosed with IBS - Constipation (IBS-C)
11207840|NCT02246647|BG002|Baseline|Total|Total of all reporting groups
11207841|NCT02246647|FG000|Participant Flow|Healthy Volunteers|"Healthy subjects ages 18 - 65 Must not have had any abdominal surgeries, IBS, IBD, microscopic colitis or celiac disease. Must not have used tobacco products in the last 6 months. Must not have used corticosteroids in the last 6 weeks. Must not have taken any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron . Must not be taking any drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors. Must not have taken anti-cholinergic agents (e.g. dicyclomine, hyoscyamine, propantheline), Ultram. No GI preparations~Anti-nausea agents (e.g., trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)~Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as MiraLAX and GlycoLax) - Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone); Antimuscarinics;Peppermint oil;Systemic antibiotics, rifaximin, metronidazole. Must not have a bleeding disorder or medications that incr"
11207842|NCT02246647|FG001|Participant Flow|IBS-C|Age (yr) 18 to 65 Must have IBS-C by Rome III criteria No abdominal surgery (except appendectomy and cholecystectomy) Exclusion criteria: Must have no History of IBD (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability) Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability) Use of oral corticosteroids within the previous 6 weeks No Ingestion of artificial sweeteners such as SplendaTM (sucralose), NutraSweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins ny treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron No drugs with a known pharmacological activity at 5
11207843|NCT02246647|OG000|Outcome|Healthy Volunteers|"Ingestion of saccharides (mannitol (regular, 12C) 100 mg, lactulose 1 g and (non-radioactive) 13C labeled mannitol, 100 mg and sucralose, 50 mg) in 250ml of water Esophagogastroduodenoscopy Flexible sigmoidoscopy~Esophagogastroduodenoscopy: Duodenal biopsies will be collected from Healthy Volunteers.~Flexible sigmoidoscopy: Colonic biopsies will be collected from Healthy Volunteers."
11207844|NCT02246647|OG001|Outcome|IBS - C|"Ingestion of saccharides (mannitol (regular, 12C) 100 mg, lactulose 1 g and (non-radioactive) 13C labeled mannitol, 100 mg and sucralose, 50 mg) in 250ml of water Esophagogastroduodenoscopy Flexible sigmoidoscopy~Esophagogastroduodenoscopy: Duodenal biopsies will be collected from IBS - C cases.~Flexible sigmoidoscopy: Colonic biopsies will be collected from IBS - C cases."
11207845|NCT02246647|OG000|Outcome|Healthy Volunteers|Four biopsies from duodenum from the Healthy Volunteers were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran.
11207846|NCT02246647|OG001|Outcome|IBS - C|Four biopsies from duodenum from the IBS - C cases were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran
11207847|NCT02246647|OG000|Outcome|Healthy Volunteers|Four biopsies from each site from the Healthy Volunteers were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran.
11207848|NCT02246647|OG001|Outcome|IBS - C|Four biopsies from each site from the IBS - C cases were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran
11207849|NCT02246647|OG000|Outcome|Healthy Volunteers|Four biopsies from colon from the Healthy Volunteers were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran.
11207850|NCT02246647|OG001|Outcome|IBS - C|Four biopsies from colon from the IBS - C cases were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured.Average TMR and Isc across 3-4 biopsies/subject were calculated.Paracellular flux across biopsies was measured using 4 kDa FITC-Dextran administered on the mucosal side (1 mg/mL chamber concentration). Cumulative flux at the end of three hours and rate of flux was calculated for FITC-Dextran
11244388|NCT02510794|BG001|Baseline|Port Delivery System With Ranibizumab 40mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
10969259|NCT00905268|BG000|Baseline|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969260|NCT00905268|BG001|Baseline|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969261|NCT00905268|BG002|Baseline|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969262|NCT00905268|BG003|Baseline|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969263|NCT00905268|BG004|Baseline|Total|Total of all reporting groups
10969264|NCT00905268|FG000|Participant Flow|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969265|NCT00905268|FG001|Participant Flow|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969266|NCT00905268|FG002|Participant Flow|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969267|NCT00905268|FG003|Participant Flow|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969268|NCT00905268|OG000|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969269|NCT00905268|OG001|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969270|NCT00905268|OG002|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969271|NCT00905268|OG003|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969272|NCT00905268|EG000|Reported Event|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969273|NCT00905268|EG001|Reported Event|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969274|NCT00905268|EG002|Reported Event|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969275|NCT00905268|EG003|Reported Event|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
10969276|NCT00905307|BG000|Baseline|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
10969277|NCT00905307|BG001|Baseline|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969278|NCT00905307|BG002|Baseline|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969279|NCT00905307|BG003|Baseline|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969280|NCT00905307|BG004|Baseline|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969281|NCT00905307|BG005|Baseline|Placebo|Placebo QD for 6 weeks
10969282|NCT00905307|BG006|Baseline|Total|Total of all reporting groups
10969283|NCT00905307|FG000|Participant Flow|OPC-34712 0.25 mg|0.25 mg once daily (QD) for 6 weeks
10969284|NCT00905307|FG001|Participant Flow|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969285|NCT00905307|FG002|Participant Flow|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969286|NCT00905307|FG003|Participant Flow|OPC-34712 High Dose|5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10819267|NCT00045942|OG002|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819268|NCT00045942|OG003|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819269|NCT00045942|OG000|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819270|NCT00045942|OG001|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819271|NCT00045942|OG002|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819272|NCT00045942|OG003|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819273|NCT00045942|OG000|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819274|NCT00045942|OG000|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819275|NCT00045942|OG000|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819276|NCT00045942|OG000|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819277|NCT00045942|EG000|Reported Event|PKC412 Core|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819278|NCT00045942|EG001|Reported Event|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
11286199|NCT02885181|BG002|Baseline|Filgotinib|Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10819279|NCT00045942|EG002|Reported Event|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819280|NCT00045942|EG003|Reported Event|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819281|NCT00045942|EG004|Reported Event|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
10819282|NCT00045942|EG005|Reported Event|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819283|NCT00045942|EG006|Reported Event|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819284|NCT00045942|EG007|Reported Event|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
10819285|NCT00045942|EG008|Reported Event|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
10819286|NCT00046228|BG000|Baseline|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
10819287|NCT00046228|BG001|Baseline|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
10819288|NCT00046228|BG002|Baseline|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
10819289|NCT00046228|BG003|Baseline|Total|Total of all reporting groups
10969287|NCT00905307|FG004|Participant Flow|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969288|NCT00905307|FG005|Participant Flow|Placebo|Placebo QD for 6 weeks
10969289|NCT00905307|OG000|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
10969290|NCT00905307|OG001|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
10969291|NCT00905307|OG002|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment , the physician could request a dose increase, if needed for efficacy, based on clinical judgment
10969292|NCT00905307|OG003|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
10969293|NCT00905307|OG004|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
10969294|NCT00905307|OG005|Outcome|Placebo|Placebo QD for 6 weeks
10969295|NCT00905307|OG001|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
11207851|NCT02246647|OG000|Outcome|Healthy Volunteers|Four biopsies from duodenum from the Healthy Volunteers were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured. Average TMR and Isc across 3-4 biopsies/subject were calculated. Transcellular transport was studied by using translocation of the fluorescently labeled E. coli K-12 Bio-Particles was measured using a 107 CFU/mL chamber concentration on the mucosal side. Cumulative flux at the end of three hours and rate of flux was calculated for E. coli K-12 Bio-Particles.
11286200|NCT02885181|BG003|Baseline|Placebo|GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10969296|NCT00905307|OG002|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969297|NCT00905307|OG003|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969298|NCT00905307|OG004|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg.After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
11286201|NCT02885181|BG004|Baseline|Total|Total of all reporting groups
10969299|NCT00905307|OG000|Outcome|OPC-34712 0.25 mg|0.25 mg QD
10969300|NCT00905307|OG001|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
10969301|NCT00905307|OG002|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
10969302|NCT00905307|OG003|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
10969303|NCT00905307|OG004|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
10969304|NCT00905307|OG005|Outcome|Placebo|Placebo QD
10969305|NCT00905307|OG004|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969306|NCT00905307|OG003|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
10969307|NCT00905307|OG001|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physicna could request a dose increase, if needed for efficacy, based on clinical judgment.
10969308|NCT00905307|EG000|Reported Event|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
10969309|NCT00905307|EG001|Reported Event|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969310|NCT00905307|EG002|Reported Event|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969311|NCT00905307|EG003|Reported Event|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
10969312|NCT00905307|EG004|Reported Event|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
10969313|NCT00905307|EG005|Reported Event|Placebo|Placebo QD
10969314|NCT00905359|BG000|Baseline|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
10969315|NCT00905359|BG001|Baseline|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
10969316|NCT00905359|BG002|Baseline|Total|Total of all reporting groups
10819290|NCT00046228|FG000|Participant Flow|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
10819291|NCT00046228|FG001|Participant Flow|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
10819292|NCT00046228|FG002|Participant Flow|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
10819293|NCT00046228|OG000|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
10819294|NCT00046228|OG001|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
10819295|NCT00046228|OG002|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
10819296|NCT00046228|EG000|Reported Event|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
10819297|NCT00046228|EG001|Reported Event|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
10819298|NCT00046228|EG002|Reported Event|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
10819299|NCT00046475|BG000|Baseline|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
10819300|NCT00046475|BG001|Baseline|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
10819301|NCT00046475|BG002|Baseline|Total|Total of all reporting groups
10819302|NCT00046475|FG000|Participant Flow|All Enrolled Participants|All patients who were enrolled in this study are included in this population.
11207852|NCT02246647|OG001|Outcome|IBS - C|Four biopsies from duodenum from the IBS - C cases were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured. Average TMR and Isc across 3-4 biopsies/subject were calculated. Transcellular transport was studied by using translocation of the fluorescently labeled E. coli K-12 Bio-Particles was measured using a 107 CFU/mL chamber concentration on the mucosal side. Cumulative flux at the end of three hours and rate of flux was calculated for E. coli K-12 Bio-Particles.
10819303|NCT00046475|FG001|Participant Flow|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
10819304|NCT00046475|FG002|Participant Flow|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
10819305|NCT00046475|OG000|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
10819306|NCT00046475|OG001|Outcome|Placebo|Participants received Placebo daily for 2 weeks
10819307|NCT00046475|OG000|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
10819308|NCT00046475|EG000|Reported Event|Screening/Washout|Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
10819309|NCT00046475|EG001|Reported Event|Titration|Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
10819310|NCT00046475|EG002|Reported Event|Midodrine HCl|Patients received their optimum dose of Midodrine HCl for 2 weeks.
10819311|NCT00046475|EG003|Reported Event|Placebo|Patients received Placebo for 2 weeks.
10819312|NCT00046475|EG004|Reported Event|Follow-up|Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
10819313|NCT00046566|BG000|Baseline|Soy Protein-milk-protein-carbohydrate|Soy protein-milk-protein-carbohydrate group
10819314|NCT00046566|BG001|Baseline|Milk Protein-carbohydrate-soy Protein|Milk protein-carbohydrate-soy protein group
10819315|NCT00046566|BG002|Baseline|Carbohydrate-soy Protein-milk Protein|Carbohydrate-soy protein-milk protein group
10819316|NCT00046566|BG003|Baseline|Total|Total of all reporting groups
10819317|NCT00046566|FG000|Participant Flow|Soy Protein-milk Protein-carbohydrate Group|117 participants assigned to soy protein-milk protein-carbohydrate group. They received 40 g/d soy protein for 8 weeks, then 40 g/d milk protein for 8 weeks, and finally 40 g/d carbohydrate for 8 weeks.
10819318|NCT00046566|FG001|Participant Flow|Milk Protein-carbohydrate-soy Protein Group|117 participants assigned to milk protein-carbohydrate-soy protein group. They received 40 g/d milk protein for 8 weeks, then 40 g/d carbohydrate for 8 weeks, and finally 40 g/d soy protein for 8 weeks.
10819319|NCT00046566|FG002|Participant Flow|Carbohydrate-soy Protein-milk Protein Group|118 participants assigned to carbohydrate-soy protein-milk protein group. They received 40 g/d carbohydrate for 8 weeks, then 40 g/d soy protein for 8 weeks, and finally 40 g/d milk protein for 8 weeks.
10819320|NCT00046566|OG000|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
10819321|NCT00046566|OG001|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
10819322|NCT00046566|OG002|Outcome|Carbohydrate Supplementation|Cross-over analysis of milk protein supplementation
10819323|NCT00046566|OG002|Outcome|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
10819324|NCT00046566|EG000|Reported Event|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
10819325|NCT00046566|EG001|Reported Event|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
10819326|NCT00046566|EG002|Reported Event|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
10969317|NCT00905359|FG000|Participant Flow|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
10969318|NCT00905359|FG001|Participant Flow|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
10969319|NCT00905359|OG000|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
10969320|NCT00905359|OG001|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
10969321|NCT00905359|EG000|Reported Event|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
10969322|NCT00905359|EG001|Reported Event|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
10969323|NCT00905424|BG000|Baseline|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
10969324|NCT00905424|BG001|Baseline|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
11207853|NCT02246647|OG000|Outcome|Healthy Volunteers|Four biopsies from colon from the Healthy Volunteers were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured. Average TMR and Isc across 3-4 biopsies/subject were calculated. Transcellular transport was studied by using translocation of the fluorescently labeled E. coli K-12 Bio-Particles was measured using a 107 CFU/mL chamber concentration on the mucosal side. Cumulative flux at the end of three hours and rate of flux was calculated for E. coli K-12 Bio-Particles.
11207854|NCT02246647|OG001|Outcome|IBS - C|Four biopsies from colon from the IBS - C cases were mounted in 4 mL Ussing chambers (Physiologic Instruments, San Diego, CA, USA) exposing 0.031 sq.cm area, within 45 min of collection. Chambers were filled with Krebs with 10 mM mannitol (mucosal side) and Krebs with 10 mM glucose (submucosal side).Baseline transmucosal resistance (TMR) and short circuit current (Isc) of each tissue was measured. Average TMR and Isc across 3-4 biopsies/subject were calculated. Transcellular transport was studied by using translocation of the fluorescently labeled E. coli K-12 Bio-Particles was measured using a 107 CFU/mL chamber concentration on the mucosal side. Cumulative flux at the end of three hours and rate of flux was calculated for E. coli K-12 Bio-Particles.
11244389|NCT02510794|BG002|Baseline|Port Delivery System With Ranibizumab 100mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11244390|NCT02510794|BG003|Baseline|Intravitreal Injection With Ranibizumab 0.5mg|Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
10969325|NCT00905424|BG002|Baseline|Total|Total of all reporting groups
10969326|NCT00905424|FG000|Participant Flow|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
10969327|NCT00905424|FG001|Participant Flow|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
10969328|NCT00905424|OG000|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
10969329|NCT00905424|OG001|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
10969330|NCT00905424|OG000|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
10969331|NCT00905424|OG001|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
11207855|NCT02246647|OG000|Outcome|Healthy Volunteers|Volunteers fasted for eight hours and underwent sedated esophagogastroduodenoscopy. Duodenal impedance measurements were performed using a endoscopically passed catheter that measures electrical impedance of the duodenal epithelium by mucosal contact under direct visualization. A 2 mm diameter catheter was used with two 360° circumferential sensors placed at a separation of 2mm with the end of the distal ring being 1mm away from the catheter tip. The electrodes were connected to an impedance voltage transducer via thin wires, which ran the length of the catheter traversing through the working channel of the upper endoscope. The voltage generated by the transducer was limited to produce 10µA current at a frequency of 2 kHz. Impedance was measured every 90° in duodenal circumference with a decompressed lumen after suctioning of all fluid from the lumen. The catheter was embedded in the mucosa parallel to the two sensors and measurements were taken from a steady baseline for >10s.
11207856|NCT02246647|OG001|Outcome|IBS - C|IBS - C cases fasted for eight hours and underwent sedated esophagogastroduodenoscopy. Duodenal impedance measurements were performed using a endoscopically passed catheter that measures electrical impedance of the duodenal epithelium by mucosal contact under direct visualization. A 2 mm diameter catheter was used with two 360° circumferential sensors placed at a separation of 2mm with the end of the distal ring being 1mm away from the catheter tip. The electrodes were connected to an impedance voltage transducer via thin wires, which ran the length of the catheter traversing through the working channel of the upper endoscope. The voltage generated by the transducer was limited to produce 10µA current at a frequency of 2 kHz. Impedance was measured every 90° in duodenal circumference with a decompressed lumen after suctioning of all fluid from the lumen. The catheter was embedded in the mucosa parallel to the two sensors and measurements were taken from a steady baseline for >10s.
11207857|NCT02246647|OG000|Outcome|Healthy Volunteers|Fasting, EDTA anti-coagulated, whole blood was collected from Healthy Volunteers. Samples were analyzed using an EAA kit (Spectral Diagnostic Inc, Toronto, Ontario, Canada) that utilizes a monoclonal IgM antibody specific for gram-negative bacterial lipopolysaccharide (LPS). Samples were tested in duplicate within one hour of collection using a Berthold SmartLine luminometer (photon-counting). The endotoxin activity level was calculated as follows: chemiluminescence (test sample-negative control)/chemiluminescence (positive-negative control). Average values for each participant were expressed as absolute units.
11207858|NCT02246647|OG001|Outcome|IBS - C|Fasting, EDTA anti-coagulated, whole blood was collected from IBS - C cases. Samples were analyzed using an EAA kit (Spectral Diagnostic Inc, Toronto, Ontario, Canada) that utilizes a monoclonal IgM antibody specific for gram-negative bacterial lipopolysaccharide (LPS). Samples were tested in duplicate within one hour of collection using a Berthold SmartLine luminometer (photon-counting). The endotoxin activity level was calculated as follows: chemiluminescence (test sample-negative control)/chemiluminescence (positive-negative control). Average values for each participant were expressed as absolute units.
11207859|NCT02246647|EG000|Reported Event|Healthy Volunteer|Healthy volunteers between ages 18 - 65, who have no history of IBS.
11207860|NCT02246647|EG001|Reported Event|IBS-C|ROME III IBS-C patients
11207861|NCT02246660|BG000|Baseline|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207862|NCT02246660|BG001|Baseline|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207863|NCT02246660|BG002|Baseline|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
11207864|NCT02246660|BG003|Baseline|Total|Total of all reporting groups
11207865|NCT02246660|FG000|Participant Flow|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207866|NCT02246660|FG001|Participant Flow|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207867|NCT02246660|FG002|Participant Flow|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
11207868|NCT02246660|OG000|Outcome|Resveratrol - 500 mg/Day|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207869|NCT02246660|OG001|Outcome|Resveratrol - 125 mg/Day|"The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.~OR~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
11207870|NCT02246660|OG002|Outcome|Placebo|"Placebo will be taken orally for 6 months.~Placebo: Placebo will be taken orally for 6 months."
11207871|NCT02246660|EG000|Reported Event|Resveratrol - 500 mg/Day|The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
11207872|NCT02246660|EG001|Reported Event|Resveratrol - 125 mg/Day|The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
11207873|NCT02246660|EG002|Reported Event|Placebo|Placebo will be taken orally for 6 months.
11207874|NCT02246673|BG000|Baseline|Cohort 1|
11207875|NCT02246673|BG001|Baseline|Cohort 2|
11207876|NCT02246673|BG002|Baseline|Cohort 3|
11207877|NCT02246673|BG003|Baseline|Cohort 4|
11207878|NCT02246673|BG004|Baseline|Cohort 5|
11207879|NCT02246673|BG005|Baseline|Total|Total of all reporting groups
11207880|NCT02246673|FG000|Participant Flow|Cohort 1|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)
11207881|NCT02246673|FG001|Participant Flow|Cohort 2|(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)
11207882|NCT02246673|FG002|Participant Flow|Cohort 3|(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)
11207883|NCT02246673|FG003|Participant Flow|Cohort 4|(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)
11207884|NCT02246673|FG004|Participant Flow|Cohort 5|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
11207885|NCT02246673|OG000|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
11207886|NCT02246673|OG001|Outcome|Febuxostat 80 mg|Days 7/28 Overall (Cohorts 1 through 5)
11207887|NCT02246673|OG002|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
11207888|NCT02246673|OG003|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
11207889|NCT02246673|OG004|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
11207890|NCT02246673|OG005|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
11207891|NCT02246673|OG006|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
11207892|NCT02246673|OG007|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
11207893|NCT02246673|OG008|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
11207894|NCT02246673|OG009|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
11207895|NCT02246673|OG010|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
11207896|NCT02246673|OG001|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
11207897|NCT02246673|OG000|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
11207898|NCT02246673|OG001|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
11207899|NCT02246673|OG002|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
11207900|NCT02246673|OG003|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
11207901|NCT02246673|OG004|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
11207902|NCT02246673|OG005|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
11207903|NCT02246673|OG006|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
11207904|NCT02246673|OG007|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
11207905|NCT02246673|OG008|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
11207906|NCT02246673|OG001|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
11207907|NCT02246673|OG003|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
11207908|NCT02246673|OG005|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
11207909|NCT02246673|OG007|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
11207910|NCT02246673|OG008|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
11207911|NCT02246673|OG000|Outcome|Febuxostat 40 mg|Overall (Cohorts 1 through 5)
11207912|NCT02246673|OG001|Outcome|Febuxostat 80 mg|Overall (Cohorts 1 through 5)
11207913|NCT02246673|OG002|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
11207914|NCT02246673|OG003|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
11207915|NCT02246673|OG004|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
11207916|NCT02246673|OG005|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
11207917|NCT02246673|OG006|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
11207918|NCT02246673|OG007|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
11207919|NCT02246673|OG008|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
11207920|NCT02246673|OG009|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
11207921|NCT02246673|OG010|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
11207922|NCT02246673|EG000|Reported Event|Febuxostat 40 mg|
11207923|NCT02246673|EG001|Reported Event|Febuxostat 80 mg|
11207924|NCT02246673|EG002|Reported Event|Overall RDEA3170 + Febuxostat Combination|
11207925|NCT02246764|BG000|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
11207926|NCT02246764|BG001|Baseline|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207927|NCT02246764|BG002|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207928|NCT02246764|BG003|Baseline|Total|Total of all reporting groups
11207929|NCT02246764|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11207930|NCT02246764|FG001|Participant Flow|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207931|NCT02246764|FG002|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207932|NCT02246764|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
11207933|NCT02246764|OG001|Outcome|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning and evening (PM) in both eyes (OU)
11207934|NCT02246764|OG002|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning and evening (PM) in both eyes (OU)
11207935|NCT02246764|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11244391|NCT02510794|BG004|Baseline|Total|Total of all reporting groups
11207936|NCT02246764|EG001|Reported Event|AR-13324 Ophthalmic Solution 0.02% BID|1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207937|NCT02246764|EG002|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11207938|NCT02246777|BG000|Baseline|Ex-PRESS|Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
11207939|NCT02246777|FG000|Participant Flow|Ex-PRESS|Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
11207940|NCT02246777|OG000|Outcome|Ex-PRESS|Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
11207941|NCT02246777|OG000|Outcome|Ex-PRESS None|No secondary surgical intervention
10969332|NCT00905424|EG000|Reported Event|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
11207942|NCT02246777|OG001|Outcome|Ex-PRESS + Needling|Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
11207943|NCT02246777|OG002|Outcome|Ex-PRESS + Laser Suture Lysis|Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
11207944|NCT02246777|OG003|Outcome|Ex-PRESS + Conjunctival Suture|Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
11207945|NCT02246777|OG004|Outcome|Ex-PRESS + Scleral Flap Suture|Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
11207946|NCT02246777|EG000|Reported Event|Ex-PRESS|Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
11207947|NCT02246998|BG000|Baseline|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207948|NCT02246998|BG001|Baseline|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207949|NCT02246998|BG002|Baseline|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207950|NCT02246998|BG003|Baseline|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207951|NCT02246998|BG004|Baseline|Total|Total of all reporting groups
11207952|NCT02246998|FG000|Participant Flow|STB + Iohexol|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207953|NCT02246998|FG001|Participant Flow|TVD + ATV/r + Iohexol|FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207954|NCT02246998|FG002|Participant Flow|ATR + Iohexol|EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207955|NCT02246998|FG003|Participant Flow|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207956|NCT02246998|OG000|Outcome|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207957|NCT02246998|OG001|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207958|NCT02246998|OG002|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207959|NCT02246998|OG003|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207960|NCT02246998|OG000|Outcome|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207961|NCT02246998|OG001|Outcome|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207962|NCT02246998|OG002|Outcome|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207963|NCT02246998|EG000|Reported Event|STB + Iohexol|STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207964|NCT02246998|EG001|Reported Event|TVD + ATV/r + Iohexol|TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
11207965|NCT02246998|EG002|Reported Event|ATR + Iohexol|ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207966|NCT02246998|EG003|Reported Event|ABC/3TC + ATV/r + Iohexol|ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
11207967|NCT02247011|BG000|Baseline|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207968|NCT02247011|BG001|Baseline|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207969|NCT02247011|BG002|Baseline|Total|Total of all reporting groups
10969333|NCT00905424|EG001|Reported Event|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
10969334|NCT00905437|BG000|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
10969335|NCT00905437|BG001|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
11207970|NCT02247011|FG000|Participant Flow|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.
11207971|NCT02247011|OG000|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207972|NCT02247011|OG001|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207973|NCT02247011|OG001|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207974|NCT02247011|OG001|Outcome|Non-fracture Group|Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
11207975|NCT02247011|EG000|Reported Event|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.
11207976|NCT02247063|BG000|Baseline|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207977|NCT02247063|BG001|Baseline|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207978|NCT02247063|BG002|Baseline|Total|Total of all reporting groups
11207979|NCT02247063|FG000|Participant Flow|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11286202|NCT02885181|FG000|Participant Flow|GS-9876 30 mg|GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10969336|NCT00905437|BG002|Baseline|Total|Total of all reporting groups
10969337|NCT00905437|FG000|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
10969338|NCT00905437|FG001|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
10969339|NCT00905437|OG000|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
10969340|NCT00905437|OG001|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
10969341|NCT00905437|EG000|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
10969342|NCT00905437|EG001|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
10969343|NCT00905450|BG000|Baseline|1% Twice a Day|BOL-303242-X ophthalmic suspension 1% Twice a Day
10819327|NCT00046839|BG000|Baseline|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819328|NCT00046839|BG001|Baseline|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819329|NCT00046839|BG002|Baseline|Total|Total of all reporting groups
10819330|NCT00046839|FG000|Participant Flow|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819331|NCT00046839|FG001|Participant Flow|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819332|NCT00046839|OG000|Outcome|Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
10819333|NCT00046839|OG001|Outcome|Phase I: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
10819334|NCT00046839|OG000|Outcome|Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 or 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819335|NCT00046839|EG000|Reported Event|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819336|NCT00046839|EG001|Reported Event|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
10819337|NCT00046891|BG000|Baseline|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
10819338|NCT00046891|BG001|Baseline|Placebo|Placebo: Patients will take 1 tablet BID
11286203|NCT02885181|FG001|Participant Flow|GS-9876 10 mg|GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10819339|NCT00046891|BG002|Baseline|Total|Total of all reporting groups
10819340|NCT00046891|FG000|Participant Flow|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
10819341|NCT00046891|FG001|Participant Flow|Placebo|Placebo: Patients will take 1 tablet BID
10819342|NCT00046891|OG000|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
10819343|NCT00046891|OG001|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
10819344|NCT00046891|OG000|Outcome|Ginko Bibola|Median change from baseline to different time points.
10819345|NCT00046891|OG001|Outcome|Placebo|Median change from baseline to different time points.
10819346|NCT00046891|OG000|Outcome|Stay Focused|Self-report cognition
10819347|NCT00046891|OG001|Outcome|Think Clearly|Self-report cognition
10819348|NCT00046891|OG002|Outcome|Balance Checkbook|Self-report cognition
10819349|NCT00046891|OG000|Outcome|Solve Problems|Self-report cognition
10819350|NCT00046891|OG001|Outcome|Plan Ahead|Self-report cognition
10819351|NCT00046891|OG002|Outcome|Make Decisions|Self-report cognition
10819352|NCT00046891|EG000|Reported Event|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
10819353|NCT00046891|EG001|Reported Event|Placebo|Placebo: Patients will take 1 tablet BID
10819354|NCT00046930|BG000|Baseline|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
10819355|NCT00046930|BG001|Baseline|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
10819356|NCT00046930|BG002|Baseline|Total|Total of all reporting groups
10819357|NCT00046930|FG000|Participant Flow|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
10819358|NCT00046930|FG001|Participant Flow|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
10969344|NCT00905450|BG001|Baseline|2% Once a Day|BOL-303242-X ophthalmic suspension 2% Once a Day
10969345|NCT00905450|BG002|Baseline|2% Twice a Day|BOL-303242-X ophthalmic suspension 2% Twice a Day
10969346|NCT00905450|BG003|Baseline|2% Four Times a Day|BOL-303242-X ophthalmic suspension 2% Four times a Day
10969347|NCT00905450|BG004|Baseline|3% Once a Day|BOL-303242-X ophthalmic suspension 3% Once a Day
10969348|NCT00905450|BG005|Baseline|3% Twice a Day|BOL-303242-X ophthalmic suspension 3% Twice a Day
10969349|NCT00905450|BG006|Baseline|3% Four Times a Day|BOL-303242-X ophthalmic suspension 3% Four times a Day
10969350|NCT00905450|BG007|Baseline|Vehicle|Vehicle for BOL-303242-X ophthalmic suspension
10969351|NCT00905450|BG008|Baseline|Total|Total of all reporting groups
10969352|NCT00905450|FG000|Participant Flow|1% Twice a Day|BOL-303242-X ophthalmic suspension 1% Twice a Day
10969353|NCT00905450|FG001|Participant Flow|2% Once a Day|BOL-303242-X ophthalmic suspension 2% Once a Day
10969354|NCT00905450|FG002|Participant Flow|2% Twice a Day|BOL-303242-X ophthalmic suspension 2% Twice a Day
10969355|NCT00905450|FG003|Participant Flow|2% Four Times a Day|BOL-303242-X ophthalmic suspension 2% Four times a Day
10969356|NCT00905450|FG004|Participant Flow|3% Once a Day|BOL-303242-X ophthalmic suspension 3% Once a Day
10969357|NCT00905450|FG005|Participant Flow|3% Twice a Day|BOL-303242-X ophthalmic suspension 3% Twice a Day
10969358|NCT00905450|FG006|Participant Flow|3% Four Times a Day|BOL-303242-X ophthalmic suspension 3% Four times a Day
10969359|NCT00905450|FG007|Participant Flow|Vehicle|Vehicle for BOL-303242-X ophthalmic suspension
10969360|NCT00905450|OG000|Outcome|1% Twice a Day|BOL-303242-X ophthalmic suspension 1% Twice a Day
10969361|NCT00905450|OG001|Outcome|2% Once a Day|BOL-303242-X ophthalmic suspension 2% Once a Day
10969362|NCT00905450|OG002|Outcome|2% Twice a Day|BOL-303242-X ophthalmic suspension 2% Twice a Day
10969363|NCT00905450|OG003|Outcome|2% Four Times a Day|BOL-303242-X ophthalmic suspension 2% Four times a Day
10969364|NCT00905450|OG004|Outcome|3% Once a Day|BOL-303242-X ophthalmic suspension 3% Once a Day
10969365|NCT00905450|OG005|Outcome|3% Twice a Day|BOL-303242-X ophthalmic suspension 3% Twice a Day
10969366|NCT00905450|OG006|Outcome|3% Four Times a Day|BOL-303242-X ophthalmic suspension 3% Four times a Day
10969367|NCT00905450|OG007|Outcome|Vehicle|Vehicle for BOL-303242-X ophthalmic suspension
10969368|NCT00905450|EG000|Reported Event|1% Twice a Day|BOL-303242-X ophthalmic suspension 1% Twice a Day
10969369|NCT00905450|EG001|Reported Event|2% Once a Day|BOL-303242-X ophthalmic suspension 2% Once a Day
10969370|NCT00905450|EG002|Reported Event|2% Twice a Day|BOL-303242-X ophthalmic suspension 2% Twice a Day
10969371|NCT00905450|EG003|Reported Event|2% Four Times a Day|BOL-303242-X ophthalmic suspension 2% Four times a Day
10969372|NCT00905450|EG004|Reported Event|3% Once a Day|BOL-303242-X ophthalmic suspension 3% Once a Day
10969373|NCT00905450|EG005|Reported Event|3% Twice a Day|BOL-303242-X ophthalmic suspension 3% Twice a Day
10969374|NCT00905450|EG006|Reported Event|3% Four Times a Day|BOL-303242-X ophthalmic suspension 3% Four times a Day
10969375|NCT00905450|EG007|Reported Event|Vehicle|Vehicle for BOL-303242-X ophthalmic suspension
10969376|NCT00905489|BG000|Baseline|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
10969377|NCT00905489|FG000|Participant Flow|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
10969378|NCT00905489|OG000|Outcome|NVP XR|Nevirapine XR (extended release)
10969379|NCT00905489|OG001|Outcome|NVP IR|Nevirapine IR (immediate release)
10969380|NCT00905489|OG000|Outcome|3-<6 yr|Patients 3 to < 6 years old.
10969381|NCT00905489|OG001|Outcome|6-<12 yr|Patients 6 to < 12 years old.
10969382|NCT00905489|OG002|Outcome|12-<18 yr|Patients 12 to < 18 years old.
10969383|NCT00905489|OG003|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
10969384|NCT00905489|EG000|Reported Event|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
10969385|NCT00905515|BG000|Baseline|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
10969386|NCT00905515|BG001|Baseline|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
10969387|NCT00905515|BG002|Baseline|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
10969388|NCT00905515|BG003|Baseline|Total|Total of all reporting groups
10969389|NCT00905515|FG000|Participant Flow|Remaining on CsA|Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
10969390|NCT00905515|FG001|Participant Flow|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL."
10969391|NCT00905515|FG002|Participant Flow|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
10969392|NCT00905515|OG000|Outcome|Remaining on CsA|Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
10969393|NCT00905515|OG001|Outcome|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced TAC with target trough levels 3.0-5.9 ng/mL."
11207980|NCT02247063|FG001|Participant Flow|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207981|NCT02247063|OG000|Outcome|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207982|NCT02247063|OG001|Outcome|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207983|NCT02247063|EG000|Reported Event|Placebo|"The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207984|NCT02247063|EG001|Reported Event|Experimental|"The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.~High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain."
11207985|NCT02247193|BG000|Baseline|Botulinum Toxin|"Injection of botulinum toxin into cleft lip at time of surgical repair.~Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
10819359|NCT00046930|OG000|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
10819360|NCT00046930|OG001|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
10819361|NCT00046930|EG000|Reported Event|Zosuquidar Induction|Induction treatment with daunorubicin, cytarabine and zosuquidar
10819362|NCT00046930|EG001|Reported Event|Placebo Induction|Induction treatment with daunorubicin, cytarabine and placebo
10819363|NCT00046930|EG002|Reported Event|Consolidation I|Cytarabine 1500 mg/m2 days 1-6
10819364|NCT00046930|EG003|Reported Event|Zosuquidar Consolidation II|Consolidation with Daunorubicin, Cytarabine and Zosuquidar
10819365|NCT00046930|EG004|Reported Event|Placebo Consolidation II|Consolidation with Daunorubicin, Cytarabine and Placebo
10819366|NCT00047060|BG000|Baseline|Stem Cell Transplant Therapy With Campath-1H|Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
10819367|NCT00047060|FG000|Participant Flow|Stem Cell Transplant Therapy With Campath-1H|Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
10819368|NCT00047060|OG000|Outcome|Stem Cell Transplant Therapy With Campath-1H|Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml)
10819369|NCT00047060|EG000|Reported Event|Stem Cell Transplant Therapy With Campath-1H|Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).
10819370|NCT00047320|BG000|Baseline|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
10850948|NCT03410992|OG000|Outcome|Bimekizumab 320 mg Q4W/Placebo (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
11207986|NCT02247193|BG001|Baseline|Saline|"Injection of normal saline into cleft lip at time of surgical repair.~Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207987|NCT02247193|BG002|Baseline|Total|Total of all reporting groups
11207988|NCT02247193|FG000|Participant Flow|Botulinum Toxin|"Injection of botulinum toxin into cleft lip at time of surgical repair.~Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207989|NCT02247193|FG001|Participant Flow|Saline|"Injection of normal saline into cleft lip at time of surgical repair.~Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207990|NCT02247193|OG000|Outcome|Botulinum Toxin|"Injection of botulinum toxin into cleft lip at time of surgical repair.~Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207991|NCT02247193|OG001|Outcome|Saline|"Injection of normal saline into cleft lip at time of surgical repair.~Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207992|NCT02247193|EG000|Reported Event|Botulinum Toxin|"Injection of botulinum toxin into cleft lip at time of surgical repair.~Botulinum Toxin Type A: Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207993|NCT02247193|EG001|Reported Event|Saline|"Injection of normal saline into cleft lip at time of surgical repair.~Normal Saline Injection: Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair."
11207994|NCT02247245|BG000|Baseline|Placebo First|"Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Placebo: Placebo"
11207995|NCT02247245|BG001|Baseline|Ivabradine First|"Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Ivabradine: Ivabradine 7.5mg"
11207996|NCT02247245|BG002|Baseline|Atrial Fibrillation (Low Rate)|"Atrial fibrillation with pacemaker base rate alteration: Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.~This group - low base pacing rate (30)"
11207997|NCT02247245|BG003|Baseline|Atrial Fibrilaltion (Standard Rate)|"Atrial fibrillation with pacemaker base rate alteration: Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.~This group - standard base pacing rate (60)"
11207998|NCT02247245|BG004|Baseline|Total|Total of all reporting groups
11207999|NCT02247245|FG000|Participant Flow|Placebo First|"Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Placebo: Placebo~n=13 Placebo first, washout 1 week, then Ivabradine 7.5mg"
11208000|NCT02247245|FG001|Participant Flow|Ivabradine First|"Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Ivabradine: Ivabradine 7.5mg~Ivabradine 7.5mg first, washout 1 week, then placebo"
11208001|NCT02247245|FG002|Participant Flow|Atrial Fibrillation (Low Rate)|Atrial fibrillation with pacemaker base rate alteration: Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.
11208002|NCT02247245|FG003|Participant Flow|Atrial Fibrillation (Standard Rate)|Atrial fibrillation with pacemaker base rate alteration: Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.
11208003|NCT02247245|OG000|Outcome|Placebo|"Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Placebo: Placebo"
11208004|NCT02247245|OG001|Outcome|Ivabradine|"Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Ivabradine: Ivabradine 7.5mg"
11208005|NCT02247245|OG002|Outcome|Atrial Fibrillation: Low Base Rate (+no Rate Adaptive Pacing)|"Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algorithms switched on.~Atrial fibrillation: Pacemaker base rate alteration"
11208006|NCT02247245|OG003|Outcome|Atrial Fibrn: Standard Base Rate (+Rate Adaptive Pacing)|"Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.~Atrial fibrillation: Pacemaker base rate alteration"
11208007|NCT02247245|EG000|Reported Event|Placebo|"Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Placebo: Placebo"
11208008|NCT02247245|EG001|Reported Event|Ivabradine|"Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.~Ivabradine: Ivabradine 7.5mg"
11208009|NCT02247245|EG002|Reported Event|Atrial Fibrillation (Low Rate)|Subjects are (double blind) randomised to a low base pacing rate (30) with rate adaptive algortithms switched on.
11208010|NCT02247245|EG003|Reported Event|Atrial Fibrilaltion (Standard Rate)|Subjects are (double blind) randomised to a standard base pacing rate (60) with rate adaptive algortithms switched on.
11208011|NCT02247336|BG000|Baseline|Immediate|"Patients will complete MeTree at enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208012|NCT02247336|BG001|Baseline|Delayed|"Patients will complete MeTree 12 months following enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208013|NCT02247336|BG002|Baseline|Total|Total of all reporting groups
10969394|NCT00905515|OG002|Outcome|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
10969395|NCT00905515|EG000|Reported Event|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
10969396|NCT00905515|EG001|Reported Event|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
10969397|NCT00905515|EG002|Reported Event|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
10969398|NCT00905554|BG000|Baseline|Warm Water|warm water irrigation during the insertion phase of colonoscopy
10969399|NCT00905554|BG001|Baseline|Air Insufflation|air insufflation during the insertion phase of colonoscopy
10969400|NCT00905554|BG002|Baseline|Total|Total of all reporting groups
10969401|NCT00905554|FG000|Participant Flow|Warm Water|warm water irrigation during the insertion phase of colonoscopy
10969402|NCT00905554|FG001|Participant Flow|Air Insufflation|air insufflation during the insertion phase of colonoscopy
10969403|NCT00905554|OG000|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
10969404|NCT00905554|OG001|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
10969405|NCT00905554|EG000|Reported Event|Warm Water|warm water irrigation during the insertion phase of colonoscopy
10969406|NCT00905554|EG001|Reported Event|Air Insufflation|air insufflation during the insertion phase of colonoscopy
10969407|NCT00905580|BG000|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10969408|NCT00905580|BG001|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10969409|NCT00905580|BG002|Baseline|Total|Total of all reporting groups
10969410|NCT00905580|FG000|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10969411|NCT00905580|FG001|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
11208014|NCT02247336|FG000|Participant Flow|Immediate|"Patients will complete MeTree at enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208015|NCT02247336|FG001|Participant Flow|Delayed|"Patients will complete MeTree 12 months following enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208016|NCT02247336|OG000|Outcome|Immediate|"Patients will complete MeTree at enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208017|NCT02247336|OG001|Outcome|Delayed|"Patients will complete MeTree 12 months following enrollment~MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree"
11208018|NCT02247336|EG000|Reported Event|Immediate|"Patients completed the family history platform at enrollment~Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree"
11208019|NCT02247336|EG001|Reported Event|Delayed|"Patients completed the family history platform 12 months following enrollment~Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree"
11208020|NCT02247401|BG000|Baseline|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
11208021|NCT02247401|BG001|Baseline|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208022|NCT02247401|BG002|Baseline|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208023|NCT02247401|BG003|Baseline|Total|Total of all reporting groups
11208024|NCT02247401|FG000|Participant Flow|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
11208025|NCT02247401|FG001|Participant Flow|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
10969412|NCT00905580|OG000|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10969413|NCT00905580|OG001|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10969414|NCT00905580|EG000|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
10969415|NCT00905580|EG001|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
10969416|NCT00905632|BG000|Baseline|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
10969417|NCT00905632|BG001|Baseline|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969418|NCT00905632|BG002|Baseline|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969419|NCT00905632|BG003|Baseline|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969420|NCT00905632|BG004|Baseline|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969421|NCT00905632|BG005|Baseline|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
11208026|NCT02247401|FG002|Participant Flow|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208027|NCT02247401|OG000|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
11208028|NCT02247401|OG001|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
10969422|NCT00905632|BG006|Baseline|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969423|NCT00905632|BG007|Baseline|Total|Total of all reporting groups
10969424|NCT00905632|FG000|Participant Flow|Treatment Naive (TN): Placebo|Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
11208029|NCT02247401|OG002|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208030|NCT02247401|OG000|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
11208031|NCT02247401|EG000|Reported Event|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
11208032|NCT02247401|EG001|Reported Event|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208033|NCT02247401|EG002|Reported Event|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
11208034|NCT02247440|BG000|Baseline|PegINF-ribavirin|"Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week~Ribavirin initial dosing in the morning and in the evening:~For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).~For genotypes 1, 4, 5 and 6:~800 mg/day, if bodyweight <65 kg,~1000 mg/day, if bodyweight between 66-80 kg,~1200 mg/day, if bodyweight between 81-105 kg,~1400 mg/day, if bodyweight >105 kg.~Duration: 48 weeks~Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision"
11208035|NCT02247440|FG000|Participant Flow|PegINF-ribavirin|"Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week~Ribavirin initial dosing in the morning and in the evening:~For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).~For genotypes 1, 4, 5 and 6:~800 mg/day, if bodyweight <65 kg,~1000 mg/day, if bodyweight between 66-80 kg,~1200 mg/day, if bodyweight between 81-105 kg,~1400 mg/day, if bodyweight >105 kg.~Duration: 48 weeks~Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision"
10969425|NCT00905632|FG001|Participant Flow|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
10969426|NCT00905632|FG002|Participant Flow|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
10969427|NCT00905632|FG003|Participant Flow|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
10969428|NCT00905632|FG004|Participant Flow|Treatment Experienced (TE): BI 207127 400 mg|Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
10969429|NCT00905632|FG005|Participant Flow|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
10969430|NCT00905632|FG006|Participant Flow|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
11208036|NCT02247440|OG000|Outcome|PegINF-ribavirin|"Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week~Ribavirin initial dosing in the morning and in the evening:~For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).~For genotypes 1, 4, 5 and 6:~800 mg/day, if bodyweight <65 kg,~1000 mg/day, if bodyweight between 66-80 kg,~1200 mg/day, if bodyweight between 81-105 kg,~1400 mg/day, if bodyweight >105 kg.~Duration: 48 weeks~Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision"
11208037|NCT02247440|EG000|Reported Event|PegINF-ribavirin|"Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week~Ribavirin initial dosing in the morning and in the evening:~For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).~For genotypes 1, 4, 5 and 6:~800 mg/day, if bodyweight <65 kg,~1000 mg/day, if bodyweight between 66-80 kg,~1200 mg/day, if bodyweight between 81-105 kg,~1400 mg/day, if bodyweight >105 kg.~Duration: 48 weeks~Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision"
11208038|NCT02247466|BG000|Baseline|Group A - Saline, Assesment, Rocuronium and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208039|NCT02247466|BG001|Baseline|Group B - Rocuronium, Assesment, Sugammadex and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208040|NCT02247466|BG002|Baseline|Total|Total of all reporting groups
10969431|NCT00905632|OG000|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
10969432|NCT00905632|OG001|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
11208041|NCT02247466|FG000|Participant Flow|Group A - Saline, Assesment, Rocuronium and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208042|NCT02247466|FG001|Participant Flow|Group B - Rocuronium, Assesment, Sugammadex and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208043|NCT02247466|OG000|Outcome|Group A - Saline, Assesment, Rocuronium and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208044|NCT02247466|OG001|Outcome|Group B - Rocuronium, Assesment, Sugammadex and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208045|NCT02247466|EG000|Reported Event|Group A - Saline, Assesment, Rocuronium and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again~Rocuronium and Sugammadex"
10819371|NCT00047320|FG000|Participant Flow|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
10848011|NCT00287586|FG000|Participant Flow|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
10848012|NCT00287586|FG001|Participant Flow|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
10848013|NCT00287586|OG000|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
11208046|NCT02247466|EG001|Reported Event|Group B - Rocuronium, Assesment, Sugammadex and Assesment|"Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again~Rocuronium and Sugammadex"
11208047|NCT02247479|BG000|Baseline|Sham Comparator|Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
11208048|NCT02247479|BG001|Baseline|Lampalizumab Q4W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
11208049|NCT02247479|BG002|Baseline|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
11208050|NCT02247479|BG003|Baseline|Total|Total of all reporting groups
11208051|NCT02247479|FG000|Participant Flow|Sham Comparator|Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
11208052|NCT02247479|FG001|Participant Flow|Lampalizumab Q4W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
11208053|NCT02247479|FG002|Participant Flow|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
11208054|NCT02247479|OG000|Outcome|Sham Comparator|Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
11208055|NCT02247479|OG001|Outcome|Lampalizumab Q4W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
11208056|NCT02247479|OG002|Outcome|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
11208057|NCT02247479|EG000|Reported Event|Sham Comparator|Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.
11208058|NCT02247479|EG001|Reported Event|Lampalizumab Q4W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.
11208059|NCT02247479|EG002|Reported Event|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.
11208060|NCT02247531|BG000|Baseline|Sham Comparator|Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.
11208061|NCT02247531|BG001|Baseline|Lampalizumab Q4W|Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.
11208062|NCT02247531|BG002|Baseline|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
11208063|NCT02247531|BG003|Baseline|Total|Total of all reporting groups
11208064|NCT02247531|FG000|Participant Flow|Sham Comparator|Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.
11208065|NCT02247531|FG001|Participant Flow|Lampalizumab Q4W|Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.
11208066|NCT02247531|FG002|Participant Flow|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
11208067|NCT02247531|OG000|Outcome|Sham Comparator|Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.
11208068|NCT02247531|OG001|Outcome|Lampalizumab Q4W|Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.
11208069|NCT02247531|OG002|Outcome|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
11208070|NCT02247531|EG000|Reported Event|Sham Comparator|Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.
11208071|NCT02247531|EG001|Reported Event|Lampalizumab Q4W|Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.
11208072|NCT02247531|EG002|Reported Event|Lampalizumab Q6W|Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
11208073|NCT02247739|BG000|Baseline|All Study Participants|All randomized patients
11208074|NCT02247739|FG000|Participant Flow|Treatment Sequence A|rhC1INH twice weekly / rhC1INH once weekly / saline
11208075|NCT02247739|FG001|Participant Flow|Treatments Sequence B|rhC1INH once weekly / rhC1INH twice weekly / Saline
11208076|NCT02247739|FG002|Participant Flow|Treatment Sequesce C|Saline / rhC1INH once weekly / rhC1INH twice weekly
11208077|NCT02247739|FG003|Participant Flow|Treatment Sequence D|Saline / rhC1INH twice weekly / rhC1INH once weekly
11208078|NCT02247739|FG004|Participant Flow|Treatment Sequence E|rhC1INH twice weekly / saline / rhC1INH once weekly
11208079|NCT02247739|FG005|Participant Flow|Treatment Sequence F|rhC1INH once weekly / saline / rhC1INH twice weekly
11208080|NCT02247739|OG000|Outcome|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
11208081|NCT02247739|OG001|Outcome|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
11208082|NCT02247739|OG002|Outcome|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
11208083|NCT02247739|OG000|Outcome|rhC1INH Twice Weekly|rhC1INH administered twice weekly
11208084|NCT02247739|OG001|Outcome|rhC1INH Once Weekly|rhC1INH administered once weekly
11208085|NCT02247739|EG000|Reported Event|rhC1INH Twice Weekly|"rhC1INH administered twice weekly~Recombinant human C1 inhibitor"
11208086|NCT02247739|EG001|Reported Event|rhC1INH Once Weekly|"rhC1INH administered once weekly~Recombinant human C1 inhibitor"
11208087|NCT02247739|EG002|Reported Event|Placebo (Saline) Twice Weekly|"Placebo (Saline) administered twice weekly~Placebo"
11208088|NCT02247765|BG000|Baseline|no Treatment|
11208089|NCT02247765|FG000|Participant Flow|USB Pulse Oximetry Monitor Interface Cable|"Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.~Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing."
11208090|NCT02247765|OG000|Outcome|no Treatment|
11208091|NCT02247765|EG000|Reported Event|no Treatment|
11208092|NCT02247804|BG000|Baseline|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208093|NCT02247804|BG001|Baseline|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208094|NCT02247804|BG002|Baseline|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208095|NCT02247804|BG003|Baseline|Total|Total of all reporting groups
11208096|NCT02247804|FG000|Participant Flow|Bimatoprost SR 15 μg|Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208097|NCT02247804|FG001|Participant Flow|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208098|NCT02247804|FG002|Participant Flow|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208099|NCT02247804|OG000|Outcome|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208100|NCT02247804|OG001|Outcome|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208101|NCT02247804|OG002|Outcome|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208102|NCT02247804|EG000|Reported Event|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208103|NCT02247804|EG001|Reported Event|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208104|NCT02247804|EG002|Reported Event|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208105|NCT02247960|BG000|Baseline|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
11208106|NCT02247960|BG001|Baseline|No Antibiotic|No Antibiotic
11208107|NCT02247960|BG002|Baseline|Total|Total of all reporting groups
11208108|NCT02247960|FG000|Participant Flow|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
11208109|NCT02247960|FG001|Participant Flow|No Antibiotic|No Antibiotic
11208110|NCT02247960|OG000|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
11208111|NCT02247960|OG001|Outcome|No Antibiotic|No Antibiotic
11208112|NCT02247960|EG000|Reported Event|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
11208113|NCT02247960|EG001|Reported Event|No Antibiotic|No Antibiotic
11208114|NCT02248103|BG000|Baseline|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
10848014|NCT00287586|OG001|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
11208115|NCT02248103|BG001|Baseline|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
11208116|NCT02248103|BG002|Baseline|Total|Total of all reporting groups
11208117|NCT02248103|FG000|Participant Flow|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
11208118|NCT02248103|FG001|Participant Flow|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
11208119|NCT02248103|OG000|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
11208120|NCT02248103|OG001|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
11208121|NCT02248103|EG000|Reported Event|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
11208122|NCT02248103|EG001|Reported Event|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
11208123|NCT02248246|BG000|Baseline|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
11208124|NCT02248246|FG000|Participant Flow|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
11208125|NCT02248246|OG000|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
11208126|NCT02248246|EG000|Reported Event|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
11286204|NCT02885181|FG002|Participant Flow|Filgotinib|Filgotinib 2 x 100 mg tablets orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11286205|NCT02885181|FG003|Participant Flow|Placebo|GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208127|NCT02248285|BG000|Baseline|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
11208128|NCT02248285|BG001|Baseline|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
11208129|NCT02248285|BG002|Baseline|Total|Total of all reporting groups
11208130|NCT02248285|FG000|Participant Flow|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
11208131|NCT02248285|FG001|Participant Flow|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
11208132|NCT02248285|OG000|Outcome|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
11208133|NCT02248285|OG001|Outcome|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
11208134|NCT02248285|EG000|Reported Event|Intervention|"FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.~FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014"
11208135|NCT02248285|EG001|Reported Event|Pre-intervention|Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
10850949|NCT03410992|OG001|Outcome|Bimekizumab 320 mg Q4W/Q8W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
11208136|NCT02248480|BG000|Baseline|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
11208137|NCT02248480|BG001|Baseline|Placebo|Placebo administered orally once a day for 15 weeks.
11208138|NCT02248480|BG002|Baseline|Total|Total of all reporting groups
11208139|NCT02248480|FG000|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
11208140|NCT02248480|FG001|Participant Flow|Placebo|Placebo administered orally once a day for 15 weeks.
11208141|NCT02248480|OG000|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
11208142|NCT02248480|OG001|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
11208143|NCT02248480|OG000|Outcome|Duloxetine|"Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.~Duloxetine: Administered orally"
11208144|NCT02248480|EG000|Reported Event|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
11208145|NCT02248480|EG001|Reported Event|Placebo|Placebo administered orally once a day for 15 weeks.
11208146|NCT02248558|BG000|Baseline|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
11286206|NCT02885181|OG000|Outcome|GS-9876 30 mg|GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208147|NCT02248558|BG001|Baseline|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
11208148|NCT02248558|BG002|Baseline|Total|Total of all reporting groups
11208149|NCT02248558|FG000|Participant Flow|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
11208150|NCT02248558|FG001|Participant Flow|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
11208151|NCT02248558|OG000|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
11208152|NCT02248558|OG001|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
11208153|NCT02248558|OG000|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
11208154|NCT02248558|OG001|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
11208155|NCT02248558|EG000|Reported Event|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
11208156|NCT02248558|EG001|Reported Event|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
11208157|NCT02248636|BG000|Baseline|Real Discontinuation|"This group is tapered off their previous cholinesterase inhibitor medication.~Cholinesterase inhibitor: This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo."
11208158|NCT02248636|BG001|Baseline|Sham Discontinuation|"This group receives their previous cholinesterase inhibitor medication, but in in placebo form.~Sham discontinuation: This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form."
11208159|NCT02248636|BG002|Baseline|Total|Total of all reporting groups
11208160|NCT02248636|FG000|Participant Flow|Real Discontinuation|"This group is tapered off their previous cholinesterase inhibitor medication.~Cholinesterase inhibitor: This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo."
11208161|NCT02248636|FG001|Participant Flow|Sham Discontinuation|"This group receives their previous cholinesterase inhibitor medication, but in in placebo form.~Sham discontinuation: This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form"
11208162|NCT02248636|OG000|Outcome|Real Discontinuation|"This group is tapered off their previous cholinesterase inhibitor medication.~Cholinesterase inhibitor: This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo."
10819372|NCT00047320|OG000|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
11208163|NCT02248636|OG001|Outcome|Sham Discontinuation|"This group receives their previous cholinesterase inhibitor medication, but in in placebo form.~Sham discontinuation: This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form"
11208164|NCT02248636|EG000|Reported Event|Real Discontinuation|"This group is tapered off their previous cholinesterase inhibitor medication.~Cholinesterase inhibitor: This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo."
11208165|NCT02248636|EG001|Reported Event|Sham Discontinuation|"This group receives their previous cholinesterase inhibitor medication, but in in placebo form.~Sham discontinuation: This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form"
11208166|NCT02248649|BG000|Baseline|Physical Activity|"Structured walking program~Structured physical activity: Walking instruction and encouragement"
11208167|NCT02248649|BG001|Baseline|Control|"Health education attention control~Health education: Provision of general information about a variety of health topics~Provision of general information about a variety of health"
10969433|NCT00905632|OG002|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969434|NCT00905632|OG003|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969435|NCT00905632|OG004|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969436|NCT00905632|OG005|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969437|NCT00905632|OG006|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969438|NCT00905632|OG000|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969439|NCT00905632|OG001|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969440|NCT00905632|OG002|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969441|NCT00905632|OG003|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969442|NCT00905632|OG004|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969443|NCT00905632|OG005|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969444|NCT00905632|OG000|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
11208168|NCT02248649|BG002|Baseline|Total|Total of all reporting groups
11208169|NCT02248649|FG000|Participant Flow|Physical Activity|"Structured walking program~Structured physical activity: Walking instruction and encouragement"
11208170|NCT02248649|FG001|Participant Flow|Control|"Health education attention control~Health education: Provision of general information about a variety of health topics~Provision of general information about a variety of health"
11208171|NCT02248649|OG000|Outcome|Physical Activity|"Structured walking program~Structured physical activity: Walking instruction and encouragement"
11208172|NCT02248649|OG001|Outcome|Control|"Health education attention control~Health education: Provision of general information about a variety of health topics~Provision of general information about a variety of health"
11208173|NCT02248649|EG000|Reported Event|Physical Activity|"Structured walking program~Structured physical activity: Walking instruction and encouragement"
11208174|NCT02248649|EG001|Reported Event|Control|"Health education attention control~Health education: Provision of general information about a variety of health topics~Provision of general information about a variety of health"
11208175|NCT02248662|BG000|Baseline|SEER|Data was collected from the Surveillance Epidemiology and End Results database on patients with DCIS between 1990 and 2011.
11208176|NCT02248662|BG001|Baseline|SEER-Medicare|SEER-Medicaid diagnoses from 1990-2009 linked to Medicare claims through 2010
10969445|NCT00905632|OG001|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969446|NCT00905632|OG002|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969447|NCT00905632|OG003|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969448|NCT00905632|EG000|Reported Event|Placebo|patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
10969449|NCT00905632|EG001|Reported Event|BI 207127 400 mg|patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969450|NCT00905632|EG002|Reported Event|BI 207127 600 mg|patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969451|NCT00905632|EG003|Reported Event|BI 207127 800 mg|patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
10969452|NCT00905827|BG000|Baseline|Intervention 1: In-person CAMS|Intervention: in-person CAMS training for providers
10969453|NCT00905827|BG001|Baseline|Intervention: E-training CAMS|Intervention: e-training CAMS training for providers
10969454|NCT00905827|BG002|Baseline|Control|Control: no training
10969455|NCT00905827|BG003|Baseline|Total|Total of all reporting groups
10969456|NCT00905827|FG000|Participant Flow|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
10969457|NCT00905827|FG001|Participant Flow|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
11208177|NCT02248662|BG002|Baseline|Total|Total of all reporting groups
11208178|NCT02248662|FG000|Participant Flow|Surveillance Epidemiology and End Results (SEER)-Medicare|"SEER-Medicare diagnoses from 1990-2009 linked to Medicare claims through 2010~Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer"
11208179|NCT02248662|FG001|Participant Flow|Surveillance Epidemiology and End Results (SEER)|"Data was collected from the Surveillance Epidemiology and End Results (SEER) database on patients with ductal carcinoma in situ (DCIS) between 1990 and 2011.~Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer"
11208180|NCT02248662|OG000|Outcome|SEER - Low Treatment Cluster|Low treatment intensity for primary DCIS
11208181|NCT02248662|OG001|Outcome|SEER-Medium Treatment Cluster|Medium treatment intensity for primary DCIS
11208182|NCT02248662|OG002|Outcome|SEER - High Treatment Cluster|High treatment intensity for primary DCIS
11208183|NCT02248662|OG003|Outcome|SEER-Medicare - Low Treatment Cluster|Low treatment intensity for primary DCIS
11208184|NCT02248662|OG004|Outcome|SEER-Medicare - Medium Treatment Cluster|Medium treatment intensity for primary DCIS
10969458|NCT00905827|FG002|Participant Flow|Control|Control: no training
10969459|NCT00905827|OG000|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
10969460|NCT00905827|OG001|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
10969461|NCT00905827|OG002|Outcome|Control|Control: no training
10969462|NCT00905827|EG000|Reported Event|Arm 1|"Intervention: in person CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
11208185|NCT02248662|OG005|Outcome|SEER Medicare - High Treatment Cluster|High treatment intensity for primary DCIS
11208186|NCT02248662|EG000|Reported Event|SEER|Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer
11208187|NCT02248662|EG001|Reported Event|SEER-Medicare|Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer
11208188|NCT02248675|BG000|Baseline|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208189|NCT02248675|BG001|Baseline|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208190|NCT02248675|BG002|Baseline|Total|Total of all reporting groups
11208191|NCT02248675|FG000|Participant Flow|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208192|NCT02248675|FG001|Participant Flow|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208193|NCT02248675|OG000|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208194|NCT02248675|OG001|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208195|NCT02248675|EG000|Reported Event|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208196|NCT02248675|EG001|Reported Event|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
11208197|NCT02248714|BG000|Baseline|Study Arm|"Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)~Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response."
11208198|NCT02248714|BG001|Baseline|Control Arm|Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
11208199|NCT02248714|BG002|Baseline|Total|Total of all reporting groups
11208200|NCT02248714|FG000|Participant Flow|Study Arm|"Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)~Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response."
11208201|NCT02248714|FG001|Participant Flow|Control Arm|Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
11208202|NCT02248714|OG000|Outcome|Study Arm|"Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)~Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response."
11208203|NCT02248714|OG001|Outcome|Control Arm|Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
11208204|NCT02248714|EG000|Reported Event|Study Arm|"Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)~Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response."
11208205|NCT02248714|EG001|Reported Event|Control Arm|Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
11208206|NCT02248727|BG000|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
11208207|NCT02248727|FG000|Participant Flow|Enfilcon A / Somofilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208208|NCT02248727|OG000|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208209|NCT02248727|OG001|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208210|NCT02248727|OG002|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208211|NCT02248727|OG003|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208212|NCT02248727|EG000|Reported Event|Enfilcon A to Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
11208213|NCT02248766|BG000|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
11208214|NCT02248766|FG000|Participant Flow|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
11208215|NCT02248766|OG000|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
11208216|NCT02248766|OG001|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208217|NCT02248766|OG002|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208218|NCT02248766|OG003|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
11208219|NCT02248766|EG000|Reported Event|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
11208220|NCT02248766|EG001|Reported Event|Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
11208221|NCT02248818|BG000|Baseline|AZD8108 20 mg - SAD|AZD8108 20 mg SAD, Cohort 1
11208222|NCT02248818|BG001|Baseline|AZD8108 60 mg - SAD|AZD8108 60 mg SAD, Cohort 2
11208223|NCT02248818|BG002|Baseline|AZD8108 95 mg - SAD|AZD8108 95 mg SAD, Cohort 3
11208224|NCT02248818|BG003|Baseline|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
11208225|NCT02248818|BG004|Baseline|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
11208226|NCT02248818|BG005|Baseline|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
11208227|NCT02248818|BG006|Baseline|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
11208228|NCT02248818|BG007|Baseline|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
11208229|NCT02248818|BG008|Baseline|Total|Total of all reporting groups
11208230|NCT02248818|FG000|Participant Flow|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
11208231|NCT02248818|FG001|Participant Flow|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
11208232|NCT02248818|FG002|Participant Flow|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
11208233|NCT02248818|FG003|Participant Flow|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
11208234|NCT02248818|FG004|Participant Flow|AZD8108 50 mg|AZD8108 50 mg MAD, Cohort 5
11208235|NCT02248818|FG005|Participant Flow|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
11208236|NCT02248818|FG006|Participant Flow|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
11208237|NCT02248818|FG007|Participant Flow|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
11208238|NCT02248818|FG008|Participant Flow|Screen|Screen - no treatment
11208239|NCT02248818|OG000|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
11208240|NCT02248818|OG001|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
11208241|NCT02248818|OG002|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
11208242|NCT02248818|OG003|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
11208243|NCT02248818|OG004|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
11208244|NCT02248818|OG005|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
11208245|NCT02248818|OG006|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
11208246|NCT02248818|OG007|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
11208247|NCT02248818|EG000|Reported Event|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
11208248|NCT02248818|EG001|Reported Event|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
11208249|NCT02248818|EG002|Reported Event|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
11208250|NCT02248818|EG003|Reported Event|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
11208251|NCT02248818|EG004|Reported Event|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
11208252|NCT02248818|EG005|Reported Event|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
11208253|NCT02248818|EG006|Reported Event|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
11208254|NCT02248818|EG007|Reported Event|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
11208255|NCT02248857|BG000|Baseline|Usual Care|Employ the current standard of care. No intervention.
11208256|NCT02248857|BG001|Baseline|UMS Strategy|"Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.~Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.~A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines."
11208257|NCT02248857|BG002|Baseline|UMS Strategy + SMS Texting Reminders|"In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.~UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription."
11208258|NCT02248857|BG003|Baseline|Total|Total of all reporting groups
11208259|NCT02248857|FG000|Participant Flow|Usual Care|Employ the current standard of care. No intervention.
11208260|NCT02248857|FG001|Participant Flow|UMS Strategy|"Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.~Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.~A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines."
11208261|NCT02248857|FG002|Participant Flow|UMS Strategy + SMS Texting Reminders|"In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.~UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription."
11208262|NCT02248857|OG000|Outcome|Usual Care|Employ the current standard of care. No intervention.
11208263|NCT02248857|OG001|Outcome|UMS Strategy|"Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.~Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.~A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines."
11208264|NCT02248857|OG002|Outcome|UMS Strategy + SMS Texting Reminders|"In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.~UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription."
11208265|NCT02248857|EG000|Reported Event|Usual Care|Employ the current standard of care. No intervention.
11208266|NCT02248857|EG001|Reported Event|UMS Strategy|"Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.~Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.~A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines."
11208267|NCT02248857|EG002|Reported Event|UMS Strategy + SMS Texting Reminders|"In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.~UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.~SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription."
11208268|NCT02248922|BG000|Baseline|Tobramycin Inhalation Solution(TIS)|300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) twice a day (BID) 28days on / 28 days off
11208269|NCT02248922|BG001|Baseline|Tobramycin Inhalation Powder (TIP)|TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off
11208270|NCT02248922|BG002|Baseline|Total|Total of all reporting groups
11208271|NCT02248922|FG000|Participant Flow|Tobramycin Inhalation Solution(TIS)|300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) twice a day (BID) 28days on / 28 days off
11208272|NCT02248922|FG001|Participant Flow|Tobramycin Inhalation Powder (TIP)|TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off
11208273|NCT02248922|OG000|Outcome|Tobramycin ALL|300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off
11208274|NCT02248922|EG000|Reported Event|Tobramycin Inhalation Solution(TIS)|300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) twice a day (BID) 28days on / 28 days off
11208275|NCT02248922|EG001|Reported Event|Tobramycin Inhalation Powder (TIP)|TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off
11208276|NCT02248961|BG000|Baseline|Kanarb (Fimasartan)|60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period
11208277|NCT02248961|BG001|Baseline|Cozaar® (Losartan)|50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
11208278|NCT02248961|BG002|Baseline|Total|Total of all reporting groups
11208279|NCT02248961|FG000|Participant Flow|Kanarb (Fimasartan)|60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period
11208280|NCT02248961|FG001|Participant Flow|Cozaar® (Losartan)|50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
11208281|NCT02248961|OG000|Outcome|Kanarb (Fimasartan)|60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period
11208282|NCT02248961|OG001|Outcome|Cozaar® (Losartan)|50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
11208283|NCT02248961|EG000|Reported Event|Kanarb (Fimasartan)|60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period
11208284|NCT02248961|EG001|Reported Event|Cozaar® (Losartan)|50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period
11208285|NCT02248974|BG000|Baseline|LVAD Decision Aid|"Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.~LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.~This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE)."
11208286|NCT02248974|BG001|Baseline|No LVAD Decision Aid|The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
11208287|NCT02248974|BG002|Baseline|Total|Total of all reporting groups
11208288|NCT02248974|FG000|Participant Flow|LVAD Decision Aid|"Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.~LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.~This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE)."
11208289|NCT02248974|FG001|Participant Flow|No LVAD Decision Aid|The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
11208290|NCT02248974|OG000|Outcome|LVAD Decision Aid|"Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.~LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.~This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE)."
11208291|NCT02248974|OG001|Outcome|No LVAD Decision Aid|The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
11208292|NCT02248974|EG000|Reported Event|LVAD Decision Aid|"Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.~LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.~This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE)."
11208293|NCT02248974|EG001|Reported Event|No LVAD Decision Aid|The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
11208294|NCT02249052|BG000|Baseline|AA4500 and Placebo|"single injection of 0.58 mg study drug and placebo~Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
11208295|NCT02249052|FG000|Participant Flow|AA4500 and Placebo|"Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma~Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention"
11208296|NCT02249052|OG000|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
11208297|NCT02249052|OG001|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
11208298|NCT02249052|OG000|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
11208299|NCT02249052|OG001|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
11208300|NCT02249052|EG000|Reported Event|AA4500|"single injection of 0.58 mg study drug~AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
11208301|NCT02249052|EG001|Reported Event|Placebo|"single injection of placebo~placebo: Placebo"
11208302|NCT02249065|BG000|Baseline|Mirvaso Gel|Brimonidine Gel
11208303|NCT02249065|FG000|Participant Flow|Mirvaso Gel|Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily)
11208304|NCT02249065|OG000|Outcome|Mirvaso Gel|Brimonidine Gel
11208305|NCT02249065|EG000|Reported Event|Mirvaso Gel|Brimonidine Gel
11208306|NCT02249091|BG000|Baseline|Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208307|NCT02249091|BG001|Baseline|Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1.~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208308|NCT02249091|BG002|Baseline|Total|Total of all reporting groups
11208309|NCT02249091|FG000|Participant Flow|Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208310|NCT02249091|FG001|Participant Flow|Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1.~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208311|NCT02249091|OG000|Outcome|Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208312|NCT02249091|OG001|Outcome|Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1.~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11244392|NCT02510794|FG000|Participant Flow|Port Delivery System With Ranibizumab 10mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11208313|NCT02249091|EG000|Reported Event|Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 40 mg/m^2 twice weekly orally starting on day 2 (total of 8 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208314|NCT02249091|EG001|Reported Event|Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin|"Induction cycle: All enrolled patients were treated with selinexor, cytarabine and idarubicin as follows:~Selinexor: 60 mg flat dose twice weekly orally during weeks 1-3 of a 4-week cycle (day 2, 4, 9, 11, 16, 18; total of 6 doses per 4-week induction cycle).~Idarubcin: i.v. infusion, 10 mg/m^2, on days 1,3,5 in cycle 1.~Cytarabine: continuous i.v. infusion day 1-7, 100 mg/m^2~Up to two induction cycles were administered. If a second cycle was applied idarubicin was only given on days 1 and 3."
11208315|NCT02249104|BG000|Baseline|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
11208316|NCT02249104|FG000|Participant Flow|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
11208317|NCT02249104|OG000|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
11208318|NCT02249104|EG000|Reported Event|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
11208319|NCT02249143|BG000|Baseline|Active Comparator: CPAP and Room Air|CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.
11208320|NCT02249143|BG001|Baseline|No Intervention: Room Air|Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
11208321|NCT02249143|BG002|Baseline|Total|Total of all reporting groups
11208322|NCT02249143|FG000|Participant Flow|CPAP and Room Air|"Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.~CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone."
11208323|NCT02249143|FG001|Participant Flow|Room Air|Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
11208324|NCT02249143|OG000|Outcome|CPAP and Room Air|"Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.~CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone."
11208325|NCT02249143|OG001|Outcome|Room Air|Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
11208326|NCT02249143|EG000|Reported Event|CPAP and Room Air|"Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.~CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone."
10969463|NCT00905827|EG001|Reported Event|Arm 2|"Intervention: e-learning CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
10819373|NCT00047320|EG000|Reported Event|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
10819374|NCT00047385|BG000|Baseline|Low-Dose CT|Participants undergo low-dose helical CT examination.
10819375|NCT00047385|BG001|Baseline|Chest X-ray|Participants undergo chest x-ray examination.
10819376|NCT00047385|BG002|Baseline|Total|Total of all reporting groups
10819377|NCT00047385|FG000|Participant Flow|Low-Dose CT|Participants undergo low-dose helical CT examination.
10819378|NCT00047385|FG001|Participant Flow|Chest X-ray|Participants undergo chest x-ray examination.
10819379|NCT00047385|OG000|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
10819380|NCT00047385|OG001|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
10819381|NCT00047385|EG000|Reported Event|Low-Dose CT|Participants undergo low-dose helical CT examination.
10819382|NCT00047385|EG001|Reported Event|Chest X-ray|Participants undergo chest x-ray examination.
10969464|NCT00905827|EG002|Reported Event|Arm 3|Control Group: no training
11208327|NCT02249143|EG001|Reported Event|Room Air|Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
11208328|NCT02249182|BG000|Baseline|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208329|NCT02249182|BG001|Baseline|6 to < 12 Years Old - LDV/SOF 12 Weeks|Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
11208330|NCT02249182|BG002|Baseline|6 to < 12 Years Old - LDV/SOF 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
11208331|NCT02249182|BG003|Baseline|6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
11208332|NCT02249182|BG004|Baseline|3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208333|NCT02249182|BG005|Baseline|Total|Total of all reporting groups
10819383|NCT00047463|BG000|Baseline|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
11208334|NCT02249182|FG000|Participant Flow|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age with hepatitis C virus (HCV) genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11208335|NCT02249182|FG001|Participant Flow|6 to < 12 Years Old - LDV/SOF 12 Weeks|Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11208336|NCT02249182|FG002|Participant Flow|6 to < 12 Years Old - LDV/SOF 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
11208337|NCT02249182|FG003|Participant Flow|6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin (RBV) capsules or oral solution (dose depending on weight) for 24 weeks.
11208338|NCT02249182|FG004|Participant Flow|3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
11208339|NCT02249182|OG000|Outcome|PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208340|NCT02249182|OG001|Outcome|PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks|Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
11208341|NCT02249182|OG002|Outcome|PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208342|NCT02249182|OG000|Outcome|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208343|NCT02249182|OG001|Outcome|6 to < 12 Years Old - LDV/SOF 12 Weeks|Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
10819384|NCT00047463|BG001|Baseline|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
11208344|NCT02249182|OG002|Outcome|6 to < 12 Years Old - LDV/SOF 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
11208345|NCT02249182|OG003|Outcome|6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
11208346|NCT02249182|OG004|Outcome|3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
10819385|NCT00047463|BG002|Baseline|Total|Total of all reporting groups
10819386|NCT00047463|FG000|Participant Flow|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
10819387|NCT00047463|FG001|Participant Flow|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
10819388|NCT00047463|OG000|Outcome|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
10819389|NCT00047463|OG001|Outcome|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
10819390|NCT00047463|OG000|Outcome|Continuous Positive Airway Pressure (CPAP)|continuous positive airway pressure (CPAP): a mask treatment for sleep apnea
10819391|NCT00047463|OG001|Outcome|Placebo-CPAP|Placebo-CPAP: Placebo-CPAP
10819392|NCT00047463|OG000|Outcome|All Participants Prior to Randomization|
10819393|NCT00047463|EG000|Reported Event|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
10819394|NCT00047463|EG001|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
10819395|NCT00047619|BG000|Baseline|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
10819396|NCT00047619|BG001|Baseline|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage not directed at wound or patient"
10819397|NCT00047619|BG002|Baseline|Total|Total of all reporting groups
10819398|NCT00047619|FG000|Participant Flow|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
10819399|NCT00047619|FG001|Participant Flow|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
10819400|NCT00047619|OG000|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
10819401|NCT00047619|OG001|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
10819402|NCT00047619|EG000|Reported Event|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
10819403|NCT00047619|EG001|Reported Event|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
10819404|NCT00047697|BG000|Baseline|Donepezil HCL|Donepezil HCl: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
10819405|NCT00047697|BG001|Baseline|Placebo|Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks.
10819406|NCT00047697|BG002|Baseline|Total|Total of all reporting groups
10819407|NCT00047697|FG000|Participant Flow|Donepezil HCL|Subjects placed on 5 and 10 mg of donepezil
10819408|NCT00047697|FG001|Participant Flow|Placebo|Subjects placed on 5 mg or 10 mg of placebo
10819409|NCT00047697|OG000|Outcome|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
10819410|NCT00047697|OG001|Outcome|Placebo|Placebo used in placed of Donepezil HCL
10819411|NCT00047697|OG001|Outcome|Placebo|Placebo used in place of Donepezil HCL
10819412|NCT00047697|EG000|Reported Event|Donepezil HCL|5 mg of donepezil for 4 weeks, followed by 10 mg of donepezil for 6 weeks.
10819413|NCT00047697|EG001|Reported Event|Placebo|Placebo substituted for Donepezil HCL
10819414|NCT00047879|BG000|Baseline|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
10819415|NCT00047879|BG001|Baseline|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
10819416|NCT00047879|BG002|Baseline|Total|Total of all reporting groups
10819417|NCT00047879|FG000|Participant Flow|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
10819418|NCT00047879|FG001|Participant Flow|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
10819419|NCT00047879|OG000|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
10819420|NCT00047879|OG001|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
10819421|NCT00047879|EG000|Reported Event|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
10819422|NCT00047879|EG001|Reported Event|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
10819423|NCT00048035|BG000|Baseline|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819424|NCT00048035|BG001|Baseline|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819425|NCT00048035|BG002|Baseline|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819426|NCT00048035|BG003|Baseline|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819427|NCT00048035|BG004|Baseline|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819428|NCT00048035|BG005|Baseline|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819429|NCT00048035|BG006|Baseline|Total|Total of all reporting groups
10819430|NCT00048035|FG000|Participant Flow|Cohort 1 (RO0503821 [0.25/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819431|NCT00048035|FG001|Participant Flow|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819432|NCT00048035|FG002|Participant Flow|Cohort 3 (RO0503821 [0.4/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819433|NCT00048035|FG003|Participant Flow|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819434|NCT00048035|FG004|Participant Flow|Cohort 5 (RO0503821 [0.6/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819435|NCT00048035|FG005|Participant Flow|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819436|NCT00048035|FG006|Participant Flow|RO0503821 (1x/Week)|Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819437|NCT00048035|FG007|Participant Flow|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819438|NCT00048035|OG000|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819439|NCT00048035|OG001|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819440|NCT00048035|OG002|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819441|NCT00048035|OG003|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
11208347|NCT02249182|OG000|Outcome|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208348|NCT02249182|OG000|Outcome|12 to < 18 Years Old - LDV/SOF 12 Weeks|Male participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208349|NCT02249182|OG001|Outcome|6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks|Male participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.
11208350|NCT02249182|OG002|Outcome|3 to < 6 Years Old - LDV/SOF 12 Weeks|Male participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208351|NCT02249182|OG000|Outcome|12 to < 18 Years Old - LDV/SOF 12 Weeks|Female participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208352|NCT02249182|OG001|Outcome|6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks|Female participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.
11208353|NCT02249182|OG002|Outcome|3 to < 6 Years Old - LDV/SOF 12 Weeks|Female participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208354|NCT02249182|OG000|Outcome|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208355|NCT02249182|OG001|Outcome|6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks|Participants 6 to < 12 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.
10819442|NCT00048035|OG004|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819443|NCT00048035|OG005|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
11208356|NCT02249182|OG000|Outcome|3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208357|NCT02249182|EG000|Reported Event|12 to < 18 Years Old - LDV/SOF 12 Weeks|Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
11208358|NCT02249182|EG001|Reported Event|6 to < 12 Years Old - LDV/SOF 12 Weeks|Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
11208359|NCT02249182|EG002|Reported Event|6 to < 12 Years Old - LDV/SOF 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
11208360|NCT02249182|EG003|Reported Event|6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks|Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
11208361|NCT02249182|EG004|Reported Event|3 to < 6 Years Old - LDV/SOF 12 Weeks|Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
11208362|NCT02249585|BG000|Baseline|CS(Conventional Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch"
11208363|NCT02249585|BG001|Baseline|DS(Deep Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208364|NCT02249585|BG002|Baseline|DL(Deep Block With Low Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.~Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208365|NCT02249585|BG003|Baseline|Total|Total of all reporting groups
11208366|NCT02249585|FG000|Participant Flow|CS(Conventional Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch"
11286207|NCT02885181|OG001|Outcome|GS-9876 10 mg|GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208367|NCT02249585|FG001|Participant Flow|DS(Deep Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208368|NCT02249585|FG002|Participant Flow|DL(Deep Block With Low Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.~Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208369|NCT02249585|OG000|Outcome|CS(Conventional Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch"
11208370|NCT02249585|OG001|Outcome|DS(Deep Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208371|NCT02249585|OG002|Outcome|DL(Deep Block With Low Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.~Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208372|NCT02249585|EG000|Reported Event|CS(Conventional Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch"
11208373|NCT02249585|EG001|Reported Event|DS(Deep Block With Standard Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.~Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208374|NCT02249585|EG002|Reported Event|DL(Deep Block With Low Pressure)|"Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.~Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery~Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch"
11208375|NCT02249728|BG000|Baseline|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
11208376|NCT02249728|FG000|Participant Flow|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
11208377|NCT02249728|OG000|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
11208378|NCT02249728|OG000|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
11208379|NCT02249728|OG000|Outcome|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
11208380|NCT02249728|OG000|Outcome|Part Two Radiolabelle AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
11208381|NCT02249728|EG000|Reported Event|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
11208382|NCT02249767|BG000|Baseline|Generic Tretinoin|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208383|NCT02249767|BG001|Baseline|Brand Tretinoin|"Treatment of Acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208384|NCT02249767|BG002|Baseline|Placebo Vehicle|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208385|NCT02249767|BG003|Baseline|Total|Total of all reporting groups
11208386|NCT02249767|FG000|Participant Flow|Generic Tretinoin|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208387|NCT02249767|FG001|Participant Flow|Brand Tretinoin|"Treatment of Acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208388|NCT02249767|FG002|Participant Flow|Placebo Vehicle|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208389|NCT02249767|OG000|Outcome|Generic Tretinoin|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208390|NCT02249767|OG001|Outcome|Brand Tretinoin|"Treatment of Acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208391|NCT02249767|OG002|Outcome|Placebo Vehicle|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208392|NCT02249767|EG000|Reported Event|Generic Tretinoin|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208393|NCT02249767|EG001|Reported Event|Brand Tretinoin|"Treatment of Acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208394|NCT02249767|EG002|Reported Event|Placebo Vehicle|"Treatment of acne once daily over 12 weeks~Tretinoin: Treatment of acne once daily in evening"
11208395|NCT02249793|BG000|Baseline|Male Healthy Volunteers|Males
11208396|NCT02249793|FG000|Participant Flow|Session 1, 48-hour|Healthy volunteers; The observation time for the biosensor-derived data was a total of four months with two 48-hour sessions (Session 1 & 2) scheduled two weeks apart to extend the biosensor platform by ambulatory blood pressure monitoring (ABPM) and timestamped dietary intake (SmartIntake) as well as by collection of timed biospecimens for multiomics analysis at 12-hour intervals.
11208397|NCT02249793|OG000|Outcome|Study Group|Healthy volunteers
11208398|NCT02249793|OG000|Outcome|Session 1, 48-hour|Healthy volunteers; The observation time for the biosensor-derived data was a total of four months with two 48-hour sessions (Session 1 & 2) scheduled two weeks apart to extend the biosensor platform by ambulatory blood pressure monitoring (ABPM) and timestamped dietary intake (SmartIntake) as well as by collection of timed biospecimens for multiomics analysis at 12-hour intervals.
11208399|NCT02249793|EG000|Reported Event|Healthy Volunteers|Males
11208400|NCT02249819|BG000|Baseline|All Study Participants|Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions.
11208401|NCT02249819|FG000|Participant Flow|Anodal tDCS, Then Sham tDCS|Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy.
11208402|NCT02249819|FG001|Participant Flow|Sham tDCS, Then Anodal tDCS|Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy.
11208403|NCT02249819|OG000|Outcome|Anodal tDCS|Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
11208404|NCT02249819|OG001|Outcome|Sham tDCS|Participants received 1 single 20 min session of sham tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
11208405|NCT02249819|EG000|Reported Event|Anodal tDCS|Participants who received anodal tDCS + computerized picture-naming therapy, and were followed for 2 weeks.
11208406|NCT02249819|EG001|Reported Event|Sham tDCS|Participants who received sham tDCS + computerized picture-naming therapy, and were followed for 2 weeks.
11208407|NCT02249832|BG000|Baseline|Seated Robotic Ankle Therapy|Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.
11208408|NCT02249832|FG000|Participant Flow|Seated Robotic Ankle Therapy|Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.
11208409|NCT02249832|OG000|Outcome|Low Gait Speed Group|The low gait speed group included all subjects with a mean gait speed of <0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
11208410|NCT02249832|OG001|Outcome|Moderate Gait Speed Group|The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
11208411|NCT02249832|OG002|Outcome|High Gait Speed Group|The high gait speed group included all subjects with a mean gait speed of >0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
11208412|NCT02249832|OG000|Outcome|Low Gait Speed Group|The low gait speed group included all subjects with a mean gait speed of <0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.
11208413|NCT02249832|OG001|Outcome|Moderate Gait Speed Group|The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.
11208414|NCT02249832|OG002|Outcome|High Gait Speed Group|The high gait speed group included all subjects with a mean gait speed of >0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.
11208415|NCT02249832|EG000|Reported Event|Seated Robotic Ankle Therapy|All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.
11208416|NCT02249949|BG000|Baseline|Efatutazone Dihydrochloride|Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11208417|NCT02249949|FG000|Participant Flow|Efatutazone Dihydrochloride|Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11208418|NCT02249949|OG000|Outcome|Efatutazone Dihydrochloride|Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11208419|NCT02249949|EG000|Reported Event|Efatutazone Dihydrochloride|Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11286208|NCT02885181|OG002|Outcome|Filgotinib|Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208420|NCT02250092|BG000|Baseline|tDCS/CIMT|"Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions"
11208421|NCT02250092|BG001|Baseline|tDCS Sham/CIMT|"Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Placebo Comparator"
10969465|NCT00905840|BG000|Baseline|Two Bone Level Implants in Interforaminal Region|"All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.~The implants were placed in the interforaminal region of the mandible, one implant in each side.~Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis."
10969466|NCT00905840|FG000|Participant Flow|Titan Grade IV Implant and Titan Zircon Implant|Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
10969467|NCT00905840|OG000|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
10969468|NCT00905840|OG001|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
11208422|NCT02250092|BG002|Baseline|Total|Total of all reporting groups
10969469|NCT00905840|OG000|Outcome|Titan Grade IV Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
10969470|NCT00905840|OG001|Outcome|Titan Zirkon Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
10969471|NCT00905840|EG000|Reported Event|Two Bone Level Implants in Interforaminal Region|Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
10969472|NCT00906074|BG000|Baseline|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
10969473|NCT00906074|BG001|Baseline|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
10969474|NCT00906074|BG002|Baseline|Total|Total of all reporting groups
11208423|NCT02250092|FG000|Participant Flow|tDCS/CIMT|"Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions"
11208424|NCT02250092|FG001|Participant Flow|tDCS Sham/CIMT|"Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Placebo Comparator"
11208425|NCT02250092|OG000|Outcome|tDCS/CIMT|"Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions"
11208426|NCT02250092|OG001|Outcome|tDCS Sham/CIMT|"Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Placebo Comparator"
11208427|NCT02250092|EG000|Reported Event|tDCS/CIMT|"Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions"
11208428|NCT02250092|EG001|Reported Event|tDCS Sham/CIMT|"Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.~Placebo Comparator"
11208429|NCT02250183|BG000|Baseline|Medihoney & Santyl|Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., arm vs. leg), each with partial thickness burns of similar depth. One intervention was MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement. The other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
11208430|NCT02250183|FG000|Participant Flow|Medihoney & Santyl|Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., bilateral lower extremities), each with partial thickness burns of similar depth. One intervention was MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. MEDIHONEY® GEL dressings contains 80% honey. The other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP.
11286209|NCT02885181|OG003|Outcome|Placebo|GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208431|NCT02250183|OG000|Outcome|Medihoney & Santyl|Each patient received both interventions (MEDIHONEY® GEL & SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.
11208432|NCT02250183|OG000|Outcome|MEDIHONEY|Each patient received both interventions (MEDIHONEY® GEL & SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be MEDIHONEY ® GEL.
11208433|NCT02250183|OG001|Outcome|SANTYL|Each patient received both interventions (MEDIHONEY® GEL & SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be SANTYL ® Ointment.
11208434|NCT02250183|EG000|Reported Event|Medihoney|MEDIHONEY® was the target treatment for this arm. However, each patient received both interventions (MEDIHONEY® GEL & SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.
11208435|NCT02250183|EG001|Reported Event|Santyl|SANTYL® was the target treatment for this arm However, each patient received both interventions (MEDIHONEY® GEL & SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.
11208436|NCT02250274|BG000|Baseline|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
11208437|NCT02250274|BG001|Baseline|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
11208438|NCT02250274|BG002|Baseline|Total|Total of all reporting groups
11208439|NCT02250274|FG000|Participant Flow|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
11208440|NCT02250274|FG001|Participant Flow|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
11208441|NCT02250274|OG000|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
11208442|NCT02250274|OG001|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
10969475|NCT00906074|FG000|Participant Flow|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
10819444|NCT00048035|OG000|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819445|NCT00048035|OG001|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819446|NCT00048035|OG003|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819447|NCT00048035|OG000|Outcome|RO0503821 (1x/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819448|NCT00048035|OG001|Outcome|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819449|NCT00048035|EG000|Reported Event|RO0503821 (1/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819450|NCT00048035|EG001|Reported Event|RO0503821 (1/2week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
10819451|NCT00048048|BG000|Baseline|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819452|NCT00048048|BG001|Baseline|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819453|NCT00048048|BG002|Baseline|Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819454|NCT00048048|BG003|Baseline|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
10819455|NCT00048048|BG004|Baseline|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819456|NCT00048048|BG005|Baseline|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819457|NCT00048048|BG006|Baseline|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819458|NCT00048048|BG007|Baseline|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819459|NCT00048048|BG008|Baseline|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10969476|NCT00906074|FG001|Participant Flow|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
10969477|NCT00906074|OG000|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
10969478|NCT00906074|OG001|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
10969479|NCT00906074|EG000|Reported Event|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
10969480|NCT00906074|EG001|Reported Event|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
10969481|NCT00906087|BG000|Baseline|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969482|NCT00906087|FG000|Participant Flow|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969483|NCT00906087|OG000|Outcome|Cosopt|"Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969484|NCT00906087|OG000|Outcome|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969485|NCT00906087|OG000|Outcome|Cosopt|"Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969486|NCT00906087|EG000|Reported Event|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
10969487|NCT00906087|EG001|Reported Event|Washout (no Glaucoma Medication)|After appropriate washout, no glaucoma medication was administered for 6 weeks.
10969488|NCT00906165|BG000|Baseline|1- Immediately Provisionalized|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969489|NCT00906165|BG001|Baseline|2- Delayed Loading|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969490|NCT00906165|BG002|Baseline|Total|Total of all reporting groups
10969491|NCT00906165|FG000|Participant Flow|1- Immediately Provisionalized|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969492|NCT00906165|FG001|Participant Flow|2- Delayed Loading|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
11208443|NCT02250274|OG000|Outcome|IIV-IIV|Participants receiving IIV in 2013-14 and IIV again in 2014-15.
11208444|NCT02250274|OG001|Outcome|IIV-LAIV|Participants receiving IIV in 2013-14 and LAIV in 2014-15.
11208445|NCT02250274|OG002|Outcome|LAIV-IIV|Participants receiving LAIV in 2013-14 and IIV in 2014-15.
11208446|NCT02250274|OG003|Outcome|LAIV-LAIV|Participants receiving LAIV in 2013-14 and LAIV in 2014-15.
11208447|NCT02250274|OG004|Outcome|Unvax-IIV|Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.
10819460|NCT00048048|BG009|Baseline|Total|Total of all reporting groups
10819461|NCT00048048|FG000|Participant Flow|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819462|NCT00048048|FG001|Participant Flow|Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819463|NCT00048048|FG002|Participant Flow|Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819464|NCT00048048|FG003|Participant Flow|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819465|NCT00048048|FG004|Participant Flow|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819466|NCT00048048|FG005|Participant Flow|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819467|NCT00048048|FG006|Participant Flow|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819468|NCT00048048|FG007|Participant Flow|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819469|NCT00048048|FG008|Participant Flow|Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819470|NCT00048048|FG009|Participant Flow|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819471|NCT00048048|FG010|Participant Flow|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819472|NCT00048048|FG011|Participant Flow|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819473|NCT00048048|OG000|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants in received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819474|NCT00048048|OG001|Outcome|Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819475|NCT00048048|OG002|Outcome|Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819476|NCT00048048|OG003|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants in received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
11208448|NCT02250274|OG005|Outcome|Unvax-LAIV|Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.
10969493|NCT00906165|OG000|Outcome|1- Immediately Provisionalized|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969494|NCT00906165|OG001|Outcome|2- Delayed Loading|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969495|NCT00906165|EG000|Reported Event|1- Immediately Provisionalized|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969496|NCT00906165|EG001|Reported Event|2- Delayed Loading|"The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.~Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)"
10969497|NCT00906178|BG000|Baseline|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
10969498|NCT00906178|BG001|Baseline|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
10969499|NCT00906178|BG002|Baseline|Total|Total of all reporting groups
10969500|NCT00906178|FG000|Participant Flow|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
10969501|NCT00906178|FG001|Participant Flow|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
10969502|NCT00906178|OG000|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
10969503|NCT00906178|OG001|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
10969504|NCT00906178|EG000|Reported Event|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
10969505|NCT00906178|EG001|Reported Event|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
10969506|NCT00906204|BG000|Baseline|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
10969507|NCT00906204|BG001|Baseline|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
10969508|NCT00906204|BG002|Baseline|Total|Total of all reporting groups
10969509|NCT00906204|FG000|Participant Flow|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
11208449|NCT02250274|EG000|Reported Event|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
11286210|NCT02885181|OG001|Outcome|GS-9876 - 10 mg|GS-9876 10 mg tablet orally once daily + Filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10819477|NCT00048048|OG004|Outcome|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819478|NCT00048048|OG005|Outcome|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819479|NCT00048048|OG006|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants in received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819480|NCT00048048|OG007|Outcome|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819481|NCT00048048|OG008|Outcome|Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819482|NCT00048048|OG000|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819483|NCT00048048|OG001|Outcome|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819484|NCT00048048|OG002|Outcome|Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819485|NCT00048048|OG003|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
10819486|NCT00048048|OG006|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819487|NCT00048048|OG008|Outcome|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819488|NCT00048048|OG000|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
10819489|NCT00048048|OG003|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819490|NCT00048048|OG000|Outcome|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819491|NCT00048048|OG001|Outcome|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819492|NCT00048048|OG002|Outcome|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
11286211|NCT02885181|OG001|Outcome|GS-9876 - 10 mg|GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11286212|NCT02885181|OG002|Outcome|Filgotinib|Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks Background therapy with methotrexate orally or parenterally once weekly
10819493|NCT00048048|OG001|Outcome|RO0503821 (1x/2week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819494|NCT00048048|OG002|Outcome|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819495|NCT00048048|EG000|Reported Event|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819496|NCT00048048|EG001|Reported Event|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819497|NCT00048048|EG002|Reported Event|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
10819498|NCT00048061|BG000|Baseline|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819499|NCT00048061|BG001|Baseline|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819500|NCT00048061|BG002|Baseline|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819501|NCT00048061|BG003|Baseline|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819502|NCT00048061|BG004|Baseline|Total|Total of all reporting groups
10819503|NCT00048061|FG000|Participant Flow|Ibandronate 2.5 mg|Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
10819504|NCT00048061|FG001|Participant Flow|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819505|NCT00048061|FG002|Participant Flow|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819506|NCT00048061|FG003|Participant Flow|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819507|NCT00048061|OG000|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819508|NCT00048061|OG001|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819509|NCT00048061|OG002|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819510|NCT00048061|OG003|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819511|NCT00048061|EG000|Reported Event|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819512|NCT00048061|EG001|Reported Event|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819513|NCT00048061|EG002|Reported Event|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819514|NCT00048061|EG003|Reported Event|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
10819515|NCT00048074|BG000|Baseline|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
10819516|NCT00048074|BG001|Baseline|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
10819517|NCT00048074|BG002|Baseline|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
10819518|NCT00048074|BG003|Baseline|Total|Total of all reporting groups
10819519|NCT00048074|FG000|Participant Flow|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
10819520|NCT00048074|FG001|Participant Flow|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
10819521|NCT00048074|FG002|Participant Flow|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
10819522|NCT00048074|OG000|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
10819523|NCT00048074|OG001|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
10819524|NCT00048074|OG002|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
10819525|NCT00048074|EG000|Reported Event|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
10819526|NCT00048074|EG001|Reported Event|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
10819527|NCT00048074|EG002|Reported Event|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
10819528|NCT00048165|BG000|Baseline|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819529|NCT00048165|BG001|Baseline|Placebo|Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819530|NCT00048165|BG002|Baseline|Total|Total of all reporting groups
10819531|NCT00048165|FG000|Participant Flow|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819532|NCT00048165|FG001|Participant Flow|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819533|NCT00048165|OG000|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819534|NCT00048165|OG001|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819535|NCT00048165|OG001|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819536|NCT00048165|OG000|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819537|NCT00048165|EG000|Reported Event|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
11244393|NCT02510794|FG001|Participant Flow|Port Delivery System With Ranibizumab 40mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
10819538|NCT00048165|EG001|Reported Event|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
10819539|NCT00048347|BG000|Baseline|Avonex|30 µg IM every week for 12 weeks
10819540|NCT00048347|FG000|Participant Flow|Avonex|30 µg IM every week for 12 weeks
10819541|NCT00048347|OG000|Outcome|Avonex|30 µg IM every week for 12 weeks
10819542|NCT00048347|EG000|Reported Event|Avonex|30 µg IM every week for 12 weeks
10819543|NCT00048542|BG000|Baseline|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819544|NCT00048542|BG001|Baseline|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
10819545|NCT00048542|BG002|Baseline|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819546|NCT00048542|BG003|Baseline|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819547|NCT00048542|BG004|Baseline|Total|Total of all reporting groups
10819548|NCT00048542|FG000|Participant Flow|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819549|NCT00048542|FG001|Participant Flow|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
10819550|NCT00048542|FG002|Participant Flow|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819551|NCT00048542|FG003|Participant Flow|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819552|NCT00048542|FG004|Participant Flow|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
10819553|NCT00048542|FG005|Participant Flow|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
10819554|NCT00048542|FG006|Participant Flow|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819555|NCT00048542|FG007|Participant Flow|Open-Label Extension FD Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819556|NCT00048542|OG000|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819557|NCT00048542|OG001|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819558|NCT00048542|OG000|Outcome|Adalimumab + MTX|Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.
10819559|NCT00048542|OG001|Outcome|Adalimumab|Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
10819560|NCT00048542|OG000|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819561|NCT00048542|OG001|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819562|NCT00048542|OG000|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819563|NCT00048542|OG001|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819564|NCT00048542|OG000|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
10819565|NCT00048542|OG001|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
10819566|NCT00048542|OG002|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
10819567|NCT00048542|OG003|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
10819568|NCT00048542|OG000|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
10819569|NCT00048542|OG002|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
10819570|NCT00048542|OG000|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
10819571|NCT00048542|OG001|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
10819572|NCT00048542|OG000|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819573|NCT00048542|OG001|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819574|NCT00048542|OG000|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819575|NCT00048542|EG000|Reported Event|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819576|NCT00048542|EG001|Reported Event|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
10819577|NCT00048542|EG002|Reported Event|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
11286213|NCT02885181|OG003|Outcome|Placebo|GS-9876 placebo tablet orally once daily + Filgotinib placebo 2 tablets orally once daily for 12 weeks Background therapy with methotrexate orally or parenterally once weekly
10819578|NCT00048542|EG003|Reported Event|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
10819579|NCT00048542|EG004|Reported Event|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
10819580|NCT00048542|EG005|Reported Event|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
10819581|NCT00048542|EG006|Reported Event|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819582|NCT00048542|EG007|Reported Event|Open-Label Extension FD Adalimumab|Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
10819583|NCT00048568|BG000|Baseline|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10819584|NCT00048568|BG001|Baseline|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10819585|NCT00048568|BG002|Baseline|Total|Total of all reporting groups
10819586|NCT00048568|FG000|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
10819587|NCT00048568|FG001|Participant Flow|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10819588|NCT00048568|FG002|Participant Flow|ABA + MTX [Open-label (OL)]|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819589|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
10819590|NCT00048568|OG001|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10819591|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
10819592|NCT00048568|OG001|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10969510|NCT00906204|FG001|Participant Flow|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
10819593|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819594|NCT00048568|OG000|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819595|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
10819596|NCT00048568|OG001|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10819597|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819598|NCT00048568|OG001|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819599|NCT00048568|OG001|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819600|NCT00048568|OG000|Outcome|ABA + MTX|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819601|NCT00048568|OG001|Outcome|MTX + Placebo|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819602|NCT00048568|OG000|Outcome|ABA + MTX Cumulative DB + OL Periods|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819603|NCT00048568|OG000|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
10819604|NCT00048568|OG001|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819605|NCT00048568|EG000|Reported Event|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
10819606|NCT00048568|EG001|Reported Event|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
10819607|NCT00048568|EG002|Reported Event|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
10969511|NCT00906204|OG000|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
11244394|NCT02510794|FG002|Participant Flow|Port Delivery System With Ranibizumab 100mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
10969512|NCT00906204|OG001|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
10969513|NCT00906204|EG000|Reported Event|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
10969514|NCT00906204|EG001|Reported Event|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
10969515|NCT00906243|BG000|Baseline|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
10969516|NCT00906243|FG000|Participant Flow|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
10969517|NCT00906243|OG000|Outcome|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
10969518|NCT00906243|EG000|Reported Event|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
10969519|NCT00906282|BG000|Baseline|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment given on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
10969520|NCT00906282|FG000|Participant Flow|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
10969521|NCT00906282|OG000|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
10969522|NCT00906282|OG000|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
10969523|NCT00906282|EG000|Reported Event|Pemetrexed/Carboplatin|All patients who received at least 1 dose of study treatment were included in the safety analysis.
10969524|NCT00906347|BG000|Baseline|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
10969525|NCT00906347|BG001|Baseline|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
10969526|NCT00906347|BG002|Baseline|Total|Total of all reporting groups
10969527|NCT00906347|FG000|Participant Flow|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
10969528|NCT00906347|FG001|Participant Flow|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
10969529|NCT00906347|OG000|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
10969530|NCT00906347|OG001|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
10969531|NCT00906347|EG000|Reported Event|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
10969532|NCT00906347|EG001|Reported Event|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
10969533|NCT00906373|BG000|Baseline|Cohort 1 - 10 mg/kg Cixutumumab|"Cixutumumab: 10 mg/kg administered by IV infusion on Day 1 of each 3-week cycle.~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle.~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
11244395|NCT02510794|FG003|Participant Flow|Intravitreal Injection With Ranibizumab 0.5mg|Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
10969534|NCT00906373|BG001|Baseline|Cohort 2 - 20 mg/kg Cixutumumab|"Cixutumumab: 20 mg/kg administered by IV infusions on Day 1 of each 3-week cycle~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969535|NCT00906373|BG002|Baseline|Total|Total of all reporting groups
11244396|NCT02510794|OG000|Outcome|Port Delivery System With Ranibizumab 10mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
10969536|NCT00906373|FG000|Participant Flow|Cohort 1 - 10 mg/kg Cixutumumab|"Cixutumumab (IMC-A12/LY3012217): 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle.~Sorafenib: 400 milligrams (mg) administered orally, twice daily on Days 1 through 21 of each 3-week cycle.~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969537|NCT00906373|FG001|Participant Flow|Cohort 2 - 20 mg/kg Cixutumumab|"Cixutumumab: 20 mg/kg administered by IV infusions on Day 1 of each 3-week cycle~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969538|NCT00906373|OG000|Outcome|Cohort 2 - 20 mg/kg Cixutumumab|"Cixutumumab: 20 mg/kg administered by IV infusions on Day 1 of each 3-week cycle~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969539|NCT00906373|OG000|Outcome|Cohort 1 - 10 mg/kg Cixutumumab|"Cixutumumab: 10 mg/kg administered by IV infusion on Day 1 of each 3-week cycle.~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle.~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969540|NCT00906373|OG001|Outcome|Cohort 2 - 20 mg/kg Cixutumumab|"Cixutumumab: 20 mg/kg administered by IV infusions on Day 1 of each 3-week cycle~Sorafenib: 400 mg administered orally, twice daily on Days 1 through 21 of each 3-week cycle~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969541|NCT00906373|EG000|Reported Event|Cohort 1 - 10 mg/kg Cixutumumab|"Cixutumumab: 10 mg/kg administered by IV infusion on Day 1 of each 3-week cycle.~Sorafenib: 400 mg administered orally, twice per day on Days 1 through 21 of each 3-week cycle.~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969542|NCT00906373|EG001|Reported Event|Cohort 2 - 20 mg/kg Cixutumumab|"Cixutumumab: 20 mg/kg administered by IV infusions on Day 1 of each 3-week cycle.~Sorafenib: 400 mg administered orally, twice per day on Days 1 through 21 of each 3-week cycle.~Treatment cycles were repeated until there was evidence of PD, toxicity, or participant withdrawal."
10969543|NCT00906399|BG000|Baseline|Placebo|Placebo every 2 weeks for 48 weeks
10969544|NCT00906399|BG001|Baseline|Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969545|NCT00906399|BG002|Baseline|Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
10969546|NCT00906399|BG003|Baseline|Total|Total of all reporting groups
10969547|NCT00906399|FG000|Participant Flow|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
10969548|NCT00906399|FG001|Participant Flow|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
11286214|NCT02885181|EG000|Reported Event|GS-9876 30 mg|GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10969549|NCT00906399|FG002|Participant Flow|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
10969550|NCT00906399|FG003|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969551|NCT00906399|FG004|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
10969552|NCT00906399|FG005|Participant Flow|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969553|NCT00906399|FG006|Participant Flow|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
10969554|NCT00906399|OG000|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
10969555|NCT00906399|OG001|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969556|NCT00906399|OG002|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
10969557|NCT00906399|EG000|Reported Event|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
10969558|NCT00906399|EG001|Reported Event|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969559|NCT00906399|EG002|Reported Event|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
10969560|NCT00906399|EG003|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969561|NCT00906399|EG004|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
10969562|NCT00906399|EG005|Reported Event|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
10969563|NCT00906399|EG006|Reported Event|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
10969564|NCT00906425|BG000|Baseline|Submerged Healing|The dental implants will be placed using a submerged healing treatment
10969565|NCT00906425|BG001|Baseline|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
10969566|NCT00906425|BG002|Baseline|Total|Total of all reporting groups
10969567|NCT00906425|FG000|Participant Flow|Submerged Healing|The dental implants will be placed using a submerged healing treatment
10969568|NCT00906425|FG001|Participant Flow|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
10969569|NCT00906425|OG000|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
10969570|NCT00906425|OG001|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
10969571|NCT00906425|EG000|Reported Event|Submerged Healing|The dental implants will be placed using a submerged healing treatment
10969572|NCT00906425|EG001|Reported Event|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
10969573|NCT00906503|BG000|Baseline|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
10969574|NCT00906503|FG000|Participant Flow|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
10969575|NCT00906503|OG000|Outcome|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
10969576|NCT00906503|EG000|Reported Event|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
11208450|NCT02250274|EG001|Reported Event|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
10969577|NCT00906698|BG000|Baseline|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969578|NCT00906698|BG001|Baseline|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969579|NCT00906698|BG002|Baseline|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969580|NCT00906698|BG003|Baseline|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969581|NCT00906698|BG004|Baseline|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969582|NCT00906698|BG005|Baseline|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969583|NCT00906698|BG006|Baseline|Total|Total of all reporting groups
10969584|NCT00906698|FG000|Participant Flow|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
10969585|NCT00906698|FG001|Participant Flow|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
11208451|NCT02250417|BG000|Baseline|All Study Participanrts|Participants with positional OSA (based on a previously performed baseline clinical study) were randomized to sleep with or without the Wave sleep surface in a cross-over design. Baseline PSG measures represent values from the previously performed clinical study that qualified subjects to have positional OSA.
11208452|NCT02250417|FG000|Participant Flow|Sequence 1|Participants randomized to Wave Sleep Surface, then to Non Wave Surface
11208453|NCT02250417|FG001|Participant Flow|Sequence 2|Participants randomized to Non Wave Sleep Surface, then to the Wave Sleep Surface
11208454|NCT02250417|OG000|Outcome|Wave Night|Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
11208455|NCT02250417|OG001|Outcome|Non-Wave Night|Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
11208456|NCT02250417|OG000|Outcome|Non-Wave Night|Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
11208457|NCT02250417|OG001|Outcome|Wave Night|Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
11208458|NCT02250417|OG001|Outcome|Non-Wave Night|"Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface when the time spent in supine position is greater than time spent in non-supine position either during the baseline (inclusion) PSG study or the Non-Wave Sleep Surface night PSG.~The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization."
11208459|NCT02250417|EG000|Reported Event|Sequence 1|"Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.~Wave sleep surface: The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep."
11208460|NCT02250417|EG001|Reported Event|Sequence 2|"Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.~Wave sleep surface: The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep."
11208461|NCT02250443|BG000|Baseline|BYM338|BYM338 Group
11208462|NCT02250443|FG000|Participant Flow|BYM338|BYM338 Group
11208463|NCT02250443|OG000|Outcome|BYM338|BYM338 Group
11208464|NCT02250443|EG000|Reported Event|BYM338 10mg/kg i.v.|BYM338 10mg/kg i.v.
11208465|NCT02250521|BG000|Baseline|McGrath Mac Intubations|All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
11208466|NCT02250521|FG000|Participant Flow|McGrath Mac Intubations|All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
11208467|NCT02250521|OG000|Outcome|McGrath Mac Intubations|All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
10850950|NCT03410992|OG002|Outcome|Bimekizumab 320 mg Q4W/Q4W (WK16ResS)|Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
11208468|NCT02250521|EG000|Reported Event|McGrath Mac Intubations|All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
11208469|NCT02250612|BG000|Baseline|SYL040012 (Bamosiran) Eye Drops Dose A|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose A"
11208470|NCT02250612|BG001|Baseline|SYL040012 (Bamosiran) Eye Drops Dose B|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose B"
11208471|NCT02250612|BG002|Baseline|SYL040012 (Bamosiran) Eye Drops Dose C|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose C"
11208472|NCT02250612|BG003|Baseline|SYL040012 (Bamosiran) Eye Drops Dose D|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose D"
11208473|NCT02250612|BG004|Baseline|Timolol Maleate 0.5% Ophthalmic Solution|"1 drop in each eye twice daily for 28 consecutive days~1 drop of timolol maleate: 0.5 %"
11208474|NCT02250612|BG005|Baseline|Total|Total of all reporting groups
11208475|NCT02250612|FG000|Participant Flow|SYL040012 (Bamosiran) 0.375% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.375 %"
11208476|NCT02250612|FG001|Participant Flow|SYL040012 (Bamosiran) 0.750 % Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.750 %"
11208477|NCT02250612|FG002|Participant Flow|SYL040012 (Bamosiran) 1.125% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.125%"
11208478|NCT02250612|FG003|Participant Flow|SYL040012 (Bamosiran) 1.5% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.5%"
11208479|NCT02250612|FG004|Participant Flow|Timolol Maleate 0.5% Ophthalmic Solution|"1 drop in each eye twice daily for 28 consecutive days~1 drop of timolol maleate: 0.5 %"
11208480|NCT02250612|OG000|Outcome|SYL040012 (Bamosiran) 0.375 % Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.375 %"
11208481|NCT02250612|OG001|Outcome|SYL040012 (Bamosiran) 0.75 % Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.75%"
11208482|NCT02250612|OG002|Outcome|SYL040012 (Bamosiran) 1.125% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.125%"
11208483|NCT02250612|OG003|Outcome|SYL040012 (Bamosiran) 1.5% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.5%"
11208484|NCT02250612|OG004|Outcome|Timolol Maleate 0.5% Ophthalmic Solution|"1 drop in each eye twice daily for 28 consecutive days~1 drop of timolol maleate: 0.5 %"
11208485|NCT02250612|OG000|Outcome|SYL040012 (Bamosiran) 1.5% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.5%"
10848015|NCT00287586|EG000|Reported Event|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
11208486|NCT02250612|OG001|Outcome|SYL040012 (Bamosiran) Eye Drops 1.125%|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.125%"
11208487|NCT02250612|OG002|Outcome|SYL040012 (Bamosiran) Eye Drops 0.75%|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.75%"
11208488|NCT02250612|OG003|Outcome|SYL040012 (Bamosiran) 0.375 % Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.375 %"
11208489|NCT02250612|OG001|Outcome|SYL040012 (Bamosiran) 1.125% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 1.125%"
11208490|NCT02250612|OG002|Outcome|SYL040012 (Bamosiran) 0.75% Eye Drops|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.75%"
11208491|NCT02250612|OG003|Outcome|SYL040012 (Bamosiran) Eye Drops 0.375%|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) 0.375%"
11208492|NCT02250612|EG000|Reported Event|SYL040012 (Bamosiran) Eye Drops Dose A|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose A"
11208493|NCT02250612|EG001|Reported Event|SYL040012 (Bamosiran) Eye Drops Dose B|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose B"
11208494|NCT02250612|EG002|Reported Event|SYL040012 (Bamosiran) Eye Drops Dose C|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose C"
11208495|NCT02250612|EG003|Reported Event|SYL040012 (Bamosiran) Eye Drops Dose D|"1 drop in each eye once daily for 28 consecutive days~1 drop of SYL040012 (bamosiran) Dose D"
11208496|NCT02250612|EG004|Reported Event|Timolol Maleate 0.5% Ophthalmic Solution|"1 drop in each eye twice daily for 28 consecutive days~1 drop of timolol maleate: 0.5 %"
11208497|NCT02250651|BG000|Baseline|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208498|NCT02250651|BG001|Baseline|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208499|NCT02250651|BG002|Baseline|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208500|NCT02250651|BG003|Baseline|Total|Total of all reporting groups
11208501|NCT02250651|FG000|Participant Flow|Bimatoprost SR 15 μg|Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208502|NCT02250651|FG001|Participant Flow|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
10848016|NCT00287586|EG001|Reported Event|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
10848017|NCT00287690|BG000|Baseline|Genistein|"Supro drink once daily for 3 days~Genistein: Drink taken once daily"
11208503|NCT02250651|FG002|Participant Flow|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208504|NCT02250651|OG000|Outcome|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208505|NCT02250651|OG001|Outcome|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208506|NCT02250651|OG002|Outcome|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208507|NCT02250651|EG000|Reported Event|Bimatoprost SR 15 μg|Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208508|NCT02250651|EG001|Reported Event|Bimatoprost SR 10 μg|Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208509|NCT02250651|EG002|Reported Event|Timolol 0.5%: Comparator|Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
11208510|NCT02250703|BG000|Baseline|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
11208511|NCT02250703|BG001|Baseline|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
11208512|NCT02250703|BG002|Baseline|Total|Total of all reporting groups
10848018|NCT00287690|BG001|Baseline|Placebo|"Drink identical to Supro but containing no genistein, once daily for 3 days~Placebo: Drink taken once daily"
11208513|NCT02250703|FG000|Participant Flow|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
11208514|NCT02250703|FG001|Participant Flow|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
10848019|NCT00287690|BG002|Baseline|Total|Total of all reporting groups
11208515|NCT02250703|OG000|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
11208516|NCT02250703|OG001|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
11208517|NCT02250703|EG000|Reported Event|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication~Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
11208518|NCT02250703|EG001|Reported Event|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).~Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
11208519|NCT02250807|BG000|Baseline|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
11208520|NCT02250807|FG000|Participant Flow|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
11208521|NCT02250807|OG000|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
11208522|NCT02250807|EG000|Reported Event|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
10848020|NCT00287690|FG000|Participant Flow|Genistein|"Supro drink once daily for 3 days prior to coronary angiography~Genistein: Drink taken once daily"
11208523|NCT02251236|BG000|Baseline|Stribild Arm|"Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208524|NCT02251236|BG001|Baseline|Genvoya Arm|"Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.~Genvoya: To be administered orally, once daily with food."
11208525|NCT02251236|BG002|Baseline|Untreated Arm|"Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208526|NCT02251236|BG003|Baseline|Total|Total of all reporting groups
11208527|NCT02251236|FG000|Participant Flow|Stribild Arm|"Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208528|NCT02251236|FG001|Participant Flow|Genvoya Arm|"Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.~Genvoya: To be administered orally, once daily with food."
11208529|NCT02251236|FG002|Participant Flow|Untreated Arm|"Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208530|NCT02251236|OG000|Outcome|Stribild Arm|"Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208531|NCT02251236|OG001|Outcome|Genvoya Arm|"Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.~Genvoya: To be administered orally, once daily with food."
11208532|NCT02251236|OG002|Outcome|Untreated Arm|"Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208533|NCT02251236|EG000|Reported Event|Stribild Arm|"Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208534|NCT02251236|EG001|Reported Event|Genvoya Arm|"Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.~Genvoya: To be administered orally, once daily with food."
11208535|NCT02251236|EG002|Reported Event|Untreated Arm|"Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.~Stribild: To be administered orally, once daily with food.~Genvoya: To be administered orally, once daily with food."
11208536|NCT02251275|BG000|Baseline|Tolvaptan (From 156-13-210: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208537|NCT02251275|BG001|Baseline|Tolvaptan (From 156-13-210: Placebo)|Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208538|NCT02251275|BG002|Baseline|Tolvaptan (From 156-08-271: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.
11208539|NCT02251275|BG003|Baseline|Tolvaptan (From Other: Tolvaptan)|Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208540|NCT02251275|BG004|Baseline|Tolvaptan (From Other: Placebo)|Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208541|NCT02251275|BG005|Baseline|Total|Total of all reporting groups
11208542|NCT02251275|FG000|Participant Flow|Tolvaptan (From 156-13-210: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208543|NCT02251275|FG001|Participant Flow|Tolvaptan (From 156-13-210: Placebo)|Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208544|NCT02251275|FG002|Participant Flow|Tolvaptan (From 156-08-271: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.
11208545|NCT02251275|FG003|Participant Flow|Tolvaptan (From Other: Tolvaptan)|Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208546|NCT02251275|FG004|Participant Flow|Tolvaptan (From Other: Placebo)|Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208547|NCT02251275|OG000|Outcome|Tolvaptan (From 156-13-210: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208548|NCT02251275|OG001|Outcome|Tolvaptan (From 156-13-210: Placebo)|Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208549|NCT02251275|OG002|Outcome|Tolvaptan (From 156-08-271: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.
11208550|NCT02251275|OG003|Outcome|Tolvaptan (From Other: Tolvaptan)|Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208551|NCT02251275|OG004|Outcome|Tolvaptan (From Other: Placebo)|Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208552|NCT02251275|EG000|Reported Event|Tolvaptan (From 156-13-210: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 milligrams (mg) with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208553|NCT02251275|EG001|Reported Event|Tolvaptan (From 156-13-210: Placebo)|Participants were previously treated with placebo in Trial 156-13-210. Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208554|NCT02251275|EG002|Reported Event|Tolvaptan (From 156-08-271: Tolvaptan)|Participants were previously treated with tolvaptan in Trial 156-08-271. Participants retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211.
11208555|NCT02251275|EG003|Reported Event|Tolvaptan (From Other: Tolvaptan)|Participants were previously treated with tolvaptan in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208556|NCT02251275|EG004|Reported Event|Tolvaptan (From Other: Placebo)|Participants were previously treated with placebo in Other Trials (156-04-251 and 156-09-290). Participants initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
11208557|NCT02251379|BG000|Baseline|ECS + Medication Group|"The Environmental Control Strategy (Home Environmental Intervention) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208558|NCT02251379|BG001|Baseline|Medication Group Alone|"inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208559|NCT02251379|BG002|Baseline|Total|Total of all reporting groups
11208560|NCT02251379|FG000|Participant Flow|ECS + Medication Group|"The Environmental Control Strategy (Home Environmental Intervention) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208561|NCT02251379|FG001|Participant Flow|Medication Group Alone|"inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208562|NCT02251379|OG000|Outcome|ECS + Medication Group|"The Environmental Control Strategy (Home Environmental Intervention) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208563|NCT02251379|OG001|Outcome|Medication Group Alone|"inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208564|NCT02251379|EG000|Reported Event|ECS + Medication Group|"The Environmental Control Strategy (Home Environmental Intervention) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208565|NCT02251379|EG001|Reported Event|Medication Group Alone|"inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)~Flovent Diskus: Inhaled corticosteroids~Advair Diskus: inhaled corticosteroids + long-acting beta agonist"
11208566|NCT02251496|BG000|Baseline|Oral Nutrition Supplement (ONS-group)|"The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208567|NCT02251496|BG001|Baseline|In Between Meals Snacks (Snacks-group)|"In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208568|NCT02251496|BG002|Baseline|Total|Total of all reporting groups
11208569|NCT02251496|FG000|Participant Flow|Oral Nutrition Supplement (ONS-group)|"The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208570|NCT02251496|FG001|Participant Flow|In Between Meals Snacks (Snacks-group)|"In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208571|NCT02251496|OG000|Outcome|Oral Nutrition Supplement (ONS-group)|"The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208572|NCT02251496|OG001|Outcome|In Between Meals Snacks (Snacks-group)|"In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208573|NCT02251496|EG000|Reported Event|Oral Nutrition Supplement (ONS-group)|"The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208574|NCT02251496|EG001|Reported Event|In Between Meals Snacks (Snacks-group)|"In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).~In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital)."
11208575|NCT02251561|BG000|Baseline|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
11208576|NCT02251561|FG000|Participant Flow|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
11208577|NCT02251561|OG000|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
11208578|NCT02251561|OG001|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
11208579|NCT02251561|EG000|Reported Event|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
11208580|NCT02251561|EG001|Reported Event|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
11208581|NCT02251613|BG000|Baseline|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
11208582|NCT02251613|FG000|Participant Flow|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
11208583|NCT02251613|OG000|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
11208584|NCT02251613|OG001|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
11208585|NCT02251613|EG000|Reported Event|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
11208586|NCT02251613|EG001|Reported Event|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
11208587|NCT02251652|BG000|Baseline|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
11208588|NCT02251652|FG000|Participant Flow|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
11208589|NCT02251652|OG000|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
11208590|NCT02251652|OG001|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
11208591|NCT02251652|EG000|Reported Event|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
11208592|NCT02251652|EG001|Reported Event|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
11208593|NCT02251717|BG000|Baseline|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208594|NCT02251717|BG001|Baseline|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208595|NCT02251717|BG002|Baseline|Total|Total of all reporting groups
11208596|NCT02251717|FG000|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208597|NCT02251717|FG001|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208598|NCT02251717|OG000|Outcome|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208599|NCT02251717|OG001|Outcome|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208600|NCT02251717|EG000|Reported Event|LDV/SOF 12 Weeks|LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208601|NCT02251717|EG001|Reported Event|LDV/SOF 24 Weeks|LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
11208602|NCT02251743|BG000|Baseline|Neurofeedback Treatment|"The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:~The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)~Average voltage of theta waves~Average voltage of beta~Average ratio of theta to beta power (TBR)"
11208603|NCT02251743|BG001|Baseline|Sham Neurofeedback Treatment|"Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show training progress over successive sessions, like real NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks."
11208604|NCT02251743|BG002|Baseline|Total|Total of all reporting groups
11208605|NCT02251743|FG000|Participant Flow|Neurofeedback Treatment|"The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:~The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)~Average voltage of theta waves~Average voltage of beta~Average ratio of theta to beta power (TBR)"
11208606|NCT02251743|FG001|Participant Flow|Sham Neurofeedback Treatment|"Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show training progress over successive sessions, like real NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks."
11208607|NCT02251743|OG000|Outcome|Neurofeedback Treatment|"The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:~The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)~Average voltage of theta waves~Average voltage of beta~Average ratio of theta to beta power (TBR)"
11208608|NCT02251743|OG001|Outcome|Sham Neurofeedback Treatment|"Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show training progress over successive sessions, like real NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks."
11208609|NCT02251743|EG000|Reported Event|Neurofeedback Treatment|"The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:~The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)~Average voltage of theta waves~Average voltage of beta~Average ratio of theta to beta power (TBR)"
11244397|NCT02510794|OG001|Outcome|Port Delivery System With Ranibizumab 40mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11286215|NCT02885181|EG001|Reported Event|GS-9876 10 mg|GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11208610|NCT02251743|EG001|Reported Event|Sham Neurofeedback Treatment|"Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show training progress over successive sessions, like real NF.~Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks."
11208611|NCT02251886|BG000|Baseline|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208612|NCT02251886|BG001|Baseline|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208613|NCT02251886|BG002|Baseline|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
11208614|NCT02251886|BG003|Baseline|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
11208615|NCT02251886|BG004|Baseline|Total|Total of all reporting groups
11208616|NCT02251886|FG000|Participant Flow|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208617|NCT02251886|FG001|Participant Flow|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208618|NCT02251886|FG002|Participant Flow|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
11208619|NCT02251886|FG003|Participant Flow|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
11208620|NCT02251886|OG000|Outcome|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208621|NCT02251886|OG001|Outcome|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208622|NCT02251886|OG002|Outcome|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
11208623|NCT02251886|OG003|Outcome|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
11208624|NCT02251886|EG000|Reported Event|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208625|NCT02251886|EG001|Reported Event|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
11208626|NCT02251886|EG002|Reported Event|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
11208627|NCT02251886|EG003|Reported Event|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
11208628|NCT02251912|BG000|Baseline|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
11208629|NCT02251912|BG001|Baseline|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
11208630|NCT02251912|BG002|Baseline|Total|Total of all reporting groups
11208631|NCT02251912|FG000|Participant Flow|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
11208632|NCT02251912|FG001|Participant Flow|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
11208633|NCT02251912|OG000|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
11208634|NCT02251912|OG001|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
11208635|NCT02251912|EG000|Reported Event|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks~Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
11208636|NCT02251912|EG001|Reported Event|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks~Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
11208637|NCT02251938|BG000|Baseline|DE-109 440 μg|Medium dose of DE-109
11208638|NCT02251938|FG000|Participant Flow|DE-109 440 μg|Medium dose of DE-109
11208639|NCT02251938|OG000|Outcome|DE-109 440 μg|Medium dose of DE-109
11208640|NCT02251938|EG000|Reported Event|DE-109 440 μg|"Medium dose of DE-109~DE-109: Medium Dose of DE-109"
11208641|NCT02251990|BG000|Baseline|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
11208642|NCT02251990|BG001|Baseline|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
11208643|NCT02251990|BG002|Baseline|Total|Total of all reporting groups
11208644|NCT02251990|FG000|Participant Flow|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir fixed-dose combination (FDC) tablet once daily (q.d.) by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
11208645|NCT02251990|FG001|Participant Flow|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
11208646|NCT02251990|OG000|Outcome|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36.
11208647|NCT02251990|OG001|Outcome|Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir|Participants received a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
11208648|NCT02251990|EG000|Reported Event|Immediate Treatment Group (ITG): Grazoprevir/Elbasvir|Participants received a grazoprevir/elbasvir FDC tablet q.d. by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and were followed-up for 24 weeks to Week 36
11208649|NCT02251990|EG001|Reported Event|Deferred Treatment Group (DTG): Placebo|Participants received a placebo tablet q.d. by mouth for 12 weeks during the double-blind treatment period (Weeks 1 to 12). Participants were then followed-up for 4 weeks to Week 16.
11208650|NCT02251990|EG002|Reported Event|Deferred Treatment Group (DTG): Grazoprevir/Elbasvir|Participants received open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants were then followed-up for 24 weeks to Week 52.
11208651|NCT02252016|BG000|Baseline|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
11208652|NCT02252016|BG001|Baseline|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
11208653|NCT02252016|BG002|Baseline|Total|Total of all reporting groups
11208654|NCT02252016|FG000|Participant Flow|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
11208655|NCT02252016|FG001|Participant Flow|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
11208656|NCT02252016|OG000|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
11208657|NCT02252016|OG001|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
11208658|NCT02252016|EG000|Reported Event|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
11208659|NCT02252016|EG001|Reported Event|Deferred Treatment: Placebo Phase|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
11208660|NCT02252042|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle.
11208661|NCT02252042|BG001|Baseline|Active Comparator|Participants received methotrexate 40 mg/m^2 IV (may have been escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
11208662|NCT02252042|BG002|Baseline|Total|Total of all reporting groups
11208663|NCT02252042|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle.
11208664|NCT02252042|FG001|Participant Flow|Active Comparator|Participants received methotrexate 40 mg/m^2 IV (may have been escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
11208665|NCT02252042|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle.
11208666|NCT02252042|OG001|Outcome|Active Comparator|Participants received methotrexate 40 mg/m^2 IV (may have been escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
11208667|NCT02252042|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle.
10848021|NCT00287690|FG001|Participant Flow|Placebo|"Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.~Placebo: Drink taken once daily"
10848022|NCT00287690|OG000|Outcome|Genistein|"Supro drink once daily for 3 days prior to coronary angiography~Genistein: Drink taken once daily"
11208668|NCT02252042|EG001|Reported Event|Active Comparator|Participants received methotrexate 40 mg/m^2 IV (may have been escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
11208669|NCT02252068|BG000|Baseline|I-CBT Feasibility Pilot|"Open trial of I-CBT~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208670|NCT02252068|BG001|Baseline|I-CBT RCT|"Randomized control trial of I-CBT vs ICD~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208671|NCT02252068|BG002|Baseline|IDC RCT|"Randomized control trial of I-CBT vs ICD~IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence."
11208672|NCT02252068|BG003|Baseline|Total|Total of all reporting groups
11208673|NCT02252068|FG000|Participant Flow|I-CBT Feasibility Pilot|"Open trial of I-CBT~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208674|NCT02252068|FG001|Participant Flow|RCT I-CBT|"Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208675|NCT02252068|FG002|Participant Flow|RCT IDC|"Randomized Controlled Trial: Individual Drug Counseling Arm~IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence."
11208676|NCT02252068|OG000|Outcome|I-CBT Feasibility Pilot|"Open trial of I-CBT~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208677|NCT02252068|OG001|Outcome|RCT: I-CBT|"Randomized control trial of I-CBT vs ICD~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208678|NCT02252068|OG002|Outcome|RCT IDC|"Randomized control trial of I-CBT vs ICD~IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence."
11208679|NCT02252068|EG000|Reported Event|I-CBT Feasibility Pilot|"Open trial of I-CBT~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208680|NCT02252068|EG001|Reported Event|RCT I-CBT|"Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm~I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders."
11208681|NCT02252068|EG002|Reported Event|RCT IDC|"Randomized Controlled Trial: Individual Drug Counseling Arm~IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence."
11208682|NCT02252081|BG000|Baseline|Metformin|"500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min~metformin: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min"
11208683|NCT02252081|BG001|Baseline|Placebo|"placebo pill(s) orally per day for 16 weeks~Placebo: placebo pill(s) orally per day for 16 weeks"
11208684|NCT02252081|BG002|Baseline|Total|Total of all reporting groups
11208685|NCT02252081|FG000|Participant Flow|Metformin|"500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min~metformin: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min"
11208686|NCT02252081|FG001|Participant Flow|Placebo|"placebo pill(s) orally per day for 16 weeks~Placebo: placebo pill(s) orally per day for 16 weeks"
11208687|NCT02252081|OG000|Outcome|Metformin|"metformin 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min/1.73m^2; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min/1.73m^2~Placebo: placebo pill(s) orally per day for 16 weeks"
11208688|NCT02252081|OG001|Outcome|Placebo|"placebo pill(s) orally per day for 16 weeks~Placebo: placebo pill(s) orally per day for 16 weeks"
11208689|NCT02252081|OG000|Outcome|Metformin|"500 to 1500 mg if eGFR > 45 ml/min; 500 to 1000 mg if eGFR =< 45 ml/min~metformin: 500 to 1500 mg if eGFR > 45 ml/min; 500 to 1000 mg if eGFR =< 45 ml/min"
11208690|NCT02252081|OG000|Outcome|Metformin|500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min
11208691|NCT02252081|OG001|Outcome|Placebo|500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min
11208692|NCT02252081|OG000|Outcome|Metformin|metformin: 500 to 1500 mg orally per day if eGFR > 45 ml/min/1.73m^2; 500 to 1000 mg orally per day if eGFR =< 45 ml/min/1.73m^2 orally per day for 16 weeks
11208693|NCT02252081|OG001|Outcome|Placebo|matching placebo pill(s) 500 to 1500 mg orally per day if eGFR > 45 ml/min/1.73m^2; 500 to 1000 mg orally per day if eGFR =< 45 ml/min/1.73m^2 orally per day for 16 weeks
11208694|NCT02252081|EG000|Reported Event|Metformin|"500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min~metformin: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min"
11208695|NCT02252081|EG001|Reported Event|Placebo|"placebo pill(s) orally per day for 16 weeks~Placebo: placebo pill(s) orally per day for 16 weeks"
11208696|NCT02252133|BG000|Baseline|Overall|DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11208697|NCT02252133|FG000|Participant Flow|DT1, Then 1DAVTE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
11208698|NCT02252133|FG001|Participant Flow|1DAVTE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
11208699|NCT02252133|OG000|Outcome|Dailies Total 1|Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.
10848023|NCT00287690|OG001|Outcome|Placebo|"Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.~Placebo: Drink taken once daily"
11208700|NCT02252133|OG001|Outcome|1DAVTE|Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
11208701|NCT02252133|EG000|Reported Event|Dailies Total 1|All subjects who wore delefilcon A contact lenses
11208702|NCT02252133|EG001|Reported Event|1DAVTE|All subjects who wore narafilcon A contact lenses
11208703|NCT02252146|BG000|Baseline|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
11208704|NCT02252146|FG000|Participant Flow|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: IMO-8400 given subcutaneously twice weekly"
11208705|NCT02252146|OG000|Outcome|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
10848024|NCT00287690|EG000|Reported Event|Genistein|"Supro drink once daily for 3 days prior to coronary angiography~Genistein: Drink taken once daily"
11208706|NCT02252146|EG000|Reported Event|IMO-8400|"IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly~IMO-8400: MO-8400 given subcutaneously twice weekly"
11208707|NCT02252211|BG000|Baseline|DS-8895a 1 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208708|NCT02252211|BG001|Baseline|DS-8895a 3 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208709|NCT02252211|BG002|Baseline|Total|Total of all reporting groups
11208710|NCT02252211|FG000|Participant Flow|DS-8895a 1 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208711|NCT02252211|FG001|Participant Flow|DS-8895a 3 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208712|NCT02252211|FG002|Participant Flow|DS-8895a 10 mg/kg|Patients were to receive infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 10 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 10 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208713|NCT02252211|OG000|Outcome|DS-8895a 1 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208714|NCT02252211|OG001|Outcome|DS-8895a 3 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
11208715|NCT02252211|EG000|Reported Event|DS-8895a 1 mg/kg|"Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.~All enrolled patients are included in AE tabulations; 1 patient was enrolled but discontinued due to SAEs prior to receiving study treatment."
11208716|NCT02252211|EG001|Reported Event|DS-8895a 3 mg/kg|"Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.~All enrolled patients are included in AE tabulations."
11208717|NCT02252211|EG002|Reported Event|DS-8895a 10 mg/kg|"Patients were to have received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 10 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 10 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.~All enrolled patients are included in AE tabulations; 1 patient was enrolled but discontinued due to an SAE prior to receiving study treatment."
11208718|NCT02252354|BG000|Baseline|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
11208719|NCT02252354|BG001|Baseline|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
11208720|NCT02252354|BG002|Baseline|Total|Total of all reporting groups
11208721|NCT02252354|FG000|Participant Flow|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
11208722|NCT02252354|FG001|Participant Flow|Part 2: TAK-385 + [14C]-TAK-385|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
11208723|NCT02252354|OG000|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
11208724|NCT02252354|OG000|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
11208725|NCT02252354|EG000|Reported Event|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
11208726|NCT02252354|EG001|Reported Event|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
11208727|NCT02252406|BG000|Baseline|Ranolazine|"Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.~Ranolazine: Ranolazine 500 mg from baseline to week 3~Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24."
11208728|NCT02252406|BG001|Baseline|Placebo|"Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.~Placebo: Matching placebo tablets daily for 24 weeks."
11208729|NCT02252406|BG002|Baseline|Total|Total of all reporting groups
11208730|NCT02252406|FG000|Participant Flow|Ranolazine|"Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.~Ranolazine: Ranolazine 500 mg from baseline to week 3~Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24."
11208731|NCT02252406|FG001|Participant Flow|Placebo|"Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.~Placebo: Matching placebo tablets daily for 24 weeks."
11208732|NCT02252406|OG000|Outcome|Ranolazine Treated|We looked women randomized by table randomization to ranolazine that successfully titrated to maximum dose of tested drug (1,000 mg bid)
11208733|NCT02252406|OG001|Outcome|Placebo|We looked women randomized by table randomization to placebo that successfully titrated to maximum dose of placebo drug
11208734|NCT02252406|EG000|Reported Event|Ranolazine Treated|Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy
11208735|NCT02252406|EG001|Reported Event|Placebo|Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.
11208736|NCT02252445|BG000|Baseline|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
11208737|NCT02252445|BG001|Baseline|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
11208738|NCT02252445|BG002|Baseline|Total|Total of all reporting groups
11208739|NCT02252445|FG000|Participant Flow|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
11208740|NCT02252445|FG001|Participant Flow|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
11208741|NCT02252445|OG000|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
11208742|NCT02252445|OG001|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
11208743|NCT02252445|EG000|Reported Event|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
11208744|NCT02252445|EG001|Reported Event|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
11208745|NCT02252536|BG000|Baseline|Sugar Pill|"Matching placebo, sugar pill~Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day"
11208746|NCT02252536|BG001|Baseline|Gabapentin Enacarbil|"600 mg Gabapentin Enacarbil (Horizant)~gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day"
11208747|NCT02252536|BG002|Baseline|Total|Total of all reporting groups
11208748|NCT02252536|FG000|Participant Flow|Sugar Pill|"Matching placebo, sugar pill~Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day"
11208749|NCT02252536|FG001|Participant Flow|Gabapentin Enacarbil|"600 mg Gabapentin Enacarbil (Horizant)~gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day"
11208750|NCT02252536|OG000|Outcome|Sugar Pill|"Matching placebo, sugar pill~Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day"
11208751|NCT02252536|OG001|Outcome|Gabapentin Enacarbil|"600 mg Gabapentin Enacarbil (Horizant)~gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day"
10848025|NCT00287690|EG001|Reported Event|Placebo|"Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.~Placebo: Drink taken once daily"
10848026|NCT00287716|BG000|Baseline|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
11208752|NCT02252536|EG000|Reported Event|Sugar Pill|"Matching placebo, sugar pill~Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day"
11208753|NCT02252536|EG001|Reported Event|Gabapentin Enacarbil|"600 mg Gabapentin Enacarbil (Horizant)~gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day"
11208754|NCT02252562|BG000|Baseline|Standard Practice|Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
11208755|NCT02252562|BG001|Baseline|Personal Hand Hygiene Device|"Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),~Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback."
11208756|NCT02252562|BG002|Baseline|Total|Total of all reporting groups
11208757|NCT02252562|FG000|Participant Flow|Standard Practice|Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
11208758|NCT02252562|FG001|Participant Flow|Personal Hand Hygiene Device|"Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),~Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback."
11208759|NCT02252562|OG000|Outcome|Standard Practice|Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
11208760|NCT02252562|OG001|Outcome|Personal Hand Hygiene Device|"Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),~Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback."
11208761|NCT02252562|OG000|Outcome|Clinicians|Clinicians who were observed in for the Treatment arm utilizing the study device
11208762|NCT02252562|EG000|Reported Event|Standard Practice|Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
11208763|NCT02252562|EG001|Reported Event|Personal Hand Hygiene Device|"Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),~Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback."
11208764|NCT02252588|BG000|Baseline|Chlorhexidine|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208765|NCT02252588|BG001|Baseline|Placebo|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208766|NCT02252588|BG002|Baseline|Total|Total of all reporting groups
11208767|NCT02252588|FG000|Participant Flow|Chlorhexidine|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208768|NCT02252588|FG001|Participant Flow|Placebo|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208769|NCT02252588|OG000|Outcome|Chlorhexidine|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208770|NCT02252588|OG001|Outcome|Placebo|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208771|NCT02252588|EG000|Reported Event|Chlorhexidine|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208772|NCT02252588|EG001|Reported Event|Placebo|"Oral Rinse~Chlorhexidine: Oral Rinse~Placebo: Oral Rinse"
11208773|NCT02252666|BG000|Baseline|Neuromodulation Rehabilitation|"Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention.~Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
11208774|NCT02252666|FG000|Participant Flow|Neuromodulation Rehabilitation|"Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention.~Neuromodulation Rehabilitation: Cranial-nerve non-invasive neuromodulation (CN-NINM) uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
11208775|NCT02252666|OG000|Outcome|Neuromodulation Rehabilitation|"Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention.~Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
11208776|NCT02252666|EG000|Reported Event|Neuromodulation Rehabilitation|"Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention.~Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII."
11208777|NCT02252718|BG000|Baseline|Children 2-18 Months of Age|Children between 2 and 18 months of age who were not toilet trained
11208778|NCT02252718|FG000|Participant Flow|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
11208779|NCT02252718|OG000|Outcome|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
10848027|NCT00287716|BG001|Baseline|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
10848028|NCT00287716|BG002|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
10848029|NCT00287716|BG003|Baseline|Total|Total of all reporting groups
10848030|NCT00287716|FG000|Participant Flow|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
10848031|NCT00287716|FG001|Participant Flow|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
10848032|NCT00287716|FG002|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
11208780|NCT02252718|EG000|Reported Event|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
11208781|NCT02252744|BG000|Baseline|RA Patients|Adult patients diagnosed with rheumatoid arthritis
11208782|NCT02252744|FG000|Participant Flow|RA Patients|Adult patients diagnosed with rheumatoid arthritis
11208783|NCT02252744|OG000|Outcome|RA Patients|Adult patients diagnosed with rheumatoid arthritis
11208784|NCT02252744|EG000|Reported Event|RA Patients|Adult patients diagnosed with rheumatoid arthritis
11208785|NCT02252939|BG000|Baseline|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
11208786|NCT02252939|FG000|Participant Flow|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
11208787|NCT02252939|OG000|Outcome|Patients With Trapeziometacarpal Arthrosis Eaton Stage I|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage I~X-Ray: X-ray as part of standard care"
11208788|NCT02252939|OG001|Outcome|Patients With Trapeziometacarpal Arthrosis Eaton Stage II|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage II~X-Ray: X-ray as part of standard care"
11208789|NCT02252939|OG002|Outcome|Patients With Trapeziometacarpal Arthrosis Eaton Stage III-IV|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage III-IV~X-Ray: X-ray as part of standard care"
11208790|NCT02252939|OG000|Outcome|Patients With Thumb Pain|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis with thumb pain~X-Ray: X-ray as part of standard care"
11208791|NCT02252939|OG001|Outcome|Patients Without Thumb Pain|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis with thumb pain~X-Ray: X-ray as part of standard care"
11208792|NCT02252939|OG000|Outcome|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
11208793|NCT02252939|EG000|Reported Event|Patients With Trapeziometacarpal (TMC) Arthrosis|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"
11208794|NCT02252965|BG000|Baseline|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
11208795|NCT02252965|BG001|Baseline|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
11208796|NCT02252965|BG002|Baseline|Total|Total of all reporting groups
11208797|NCT02252965|FG000|Participant Flow|Metformin IR|Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
11208798|NCT02252965|FG001|Participant Flow|Metformin XR|Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
11208799|NCT02252965|OG000|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
11208800|NCT02252965|OG001|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
11208801|NCT02252965|OG001|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
11208802|NCT02252965|EG000|Reported Event|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
11208803|NCT02252965|EG001|Reported Event|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
11208804|NCT02252965|EG002|Reported Event|Metformin IR to XR|Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
11244398|NCT02510794|OG002|Outcome|Port Delivery System With Ranibizumab 100mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11208805|NCT02253147|BG000|Baseline|TEOSYAL® RHA Ultra Deep / Perlane-L®|"Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½ disposable sterile needles."
11208806|NCT02253147|FG000|Participant Flow|TEOSYAL® RHA Ultra Deep / Perlane-L®|"Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).~TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½ disposable sterile needles."
11208807|NCT02253147|OG000|Outcome|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
11208808|NCT02253147|OG001|Outcome|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
11208809|NCT02253147|EG000|Reported Event|TEOSYAL® RHA Ultra Deep|Injection of TEOSYAL® RHA Ultra Deep into one NLF
11208810|NCT02253147|EG001|Reported Event|Perlane-L®|Injection of Perlane-L® into the controlateral NLF
11208811|NCT02253160|BG000|Baseline|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
11208812|NCT02253160|BG001|Baseline|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208813|NCT02253160|BG002|Baseline|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208814|NCT02253160|BG003|Baseline|Total|Total of all reporting groups
11208815|NCT02253160|FG000|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
11208816|NCT02253160|FG001|Participant Flow|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208817|NCT02253160|FG002|Participant Flow|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208818|NCT02253160|OG000|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208819|NCT02253160|OG001|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
11208820|NCT02253160|OG000|Outcome|Spectra Optia|Subjects who received an CMNC collection using the Spectra Optia
11208821|NCT02253160|OG001|Outcome|COBE Spectra|Subjects who received an CMNC collection using the COBE Spectra
11208822|NCT02253160|EG000|Reported Event|Pre-collection|Subjects screened and received G-CSF.
11208823|NCT02253160|EG001|Reported Event|Spectra Optia|Subject who received Spectra Optia CMNC collection procedure.
11208824|NCT02253160|EG002|Reported Event|COBE Spectra|Subjects who received COBE Spectra MNC collection procedure.
11208825|NCT02253160|EG003|Reported Event|Follow up|Subjects who completed cross-over design and were followed for at least 1 day.
11208826|NCT02253173|BG000|Baseline|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
11208827|NCT02253173|BG001|Baseline|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
11208828|NCT02253173|BG002|Baseline|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
11208829|NCT02253173|BG003|Baseline|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
11208830|NCT02253173|BG004|Baseline|Total|Total of all reporting groups
11208831|NCT02253173|FG000|Participant Flow|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
11208832|NCT02253173|FG001|Participant Flow|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
11208833|NCT02253173|FG002|Participant Flow|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
11208834|NCT02253173|FG003|Participant Flow|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
11208835|NCT02253173|OG000|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208836|NCT02253173|OG001|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208837|NCT02253173|OG002|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208838|NCT02253173|OG003|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208839|NCT02253173|OG000|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
11208840|NCT02253173|OG001|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
11208841|NCT02253173|OG002|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
11208842|NCT02253173|OG003|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
11208843|NCT02253173|EG000|Reported Event|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208844|NCT02253173|EG001|Reported Event|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208845|NCT02253173|EG002|Reported Event|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208846|NCT02253173|EG003|Reported Event|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
11208847|NCT02253433|BG000|Baseline|Enhanced Clinic Care|This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
11208848|NCT02253433|BG001|Baseline|Enhanced Clinic Care + Home Intervention|"This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).~Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months)."
11208849|NCT02253433|BG002|Baseline|Total|Total of all reporting groups
11208850|NCT02253433|FG000|Participant Flow|Enhanced Clinic Care|This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
11208851|NCT02253433|FG001|Participant Flow|Enhanced Clinic Care + Home Intervention|"This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).~Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months)."
11208852|NCT02253433|OG000|Outcome|Enhanced Clinic Care|This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
11208853|NCT02253433|OG001|Outcome|Enhanced Clinic Care + Home Intervention|"This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).~Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months)."
11208854|NCT02253433|OG001|Outcome|Enhanced Clinic Care + Intervention|"This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).~Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months)."
11208855|NCT02253433|EG000|Reported Event|Enhanced Clinic Care|This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
11208856|NCT02253433|EG001|Reported Event|Enhanced Clinic Care + Home Intervention|"This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).~Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months)."
11208857|NCT02253537|BG000|Baseline|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
11208858|NCT02253537|FG000|Participant Flow|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
11208859|NCT02253537|OG000|Outcome|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
11208860|NCT02253537|EG000|Reported Event|Symptomatic|"Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.~CST001"
11208861|NCT02253654|BG000|Baseline|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
11208862|NCT02253654|BG001|Baseline|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
11208863|NCT02253654|BG002|Baseline|Total|Total of all reporting groups
11208864|NCT02253654|FG000|Participant Flow|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
11208865|NCT02253654|FG001|Participant Flow|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
11208866|NCT02253654|OG000|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
11208867|NCT02253654|OG001|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
11208868|NCT02253654|EG000|Reported Event|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
11208869|NCT02253654|EG001|Reported Event|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
11208870|NCT02253992|BG000|Baseline|TRT A|URE3 Q4WK+NIV3 Q2WK
11208871|NCT02253992|BG001|Baseline|TRT B|URE8 Q4WK+NIV3 Q2WK
11208872|NCT02253992|BG002|Baseline|TRT D|URE8 Q4WK+NIV240mg Q2WK
11208873|NCT02253992|BG003|Baseline|Total|Total of all reporting groups
10848033|NCT00287716|OG000|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
11208874|NCT02253992|FG000|Participant Flow|TRT A|URE3 Q4WK+NIV3 Q2WK
11208875|NCT02253992|FG001|Participant Flow|TRT B|URE8 Q4WK+NIV3 Q2WK
11208876|NCT02253992|FG002|Participant Flow|TRT D|URE8 Q4WK+NIV240mg Q2WK
11208877|NCT02253992|OG000|Outcome|TRT A|URE3 Q4WK+NIV3 Q2WK
11208878|NCT02253992|OG001|Outcome|TRT B|URE8 Q4WK+NIV3 Q2WK
11208879|NCT02253992|OG002|Outcome|TRT D|URE8 Q4WK+NIV240mg Q2WK
11208880|NCT02253992|OG000|Outcome|TRT D - NSCLC pd1/Pd-l1 Experienced|URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced
11208881|NCT02253992|OG001|Outcome|TRT D - NSCLC pd1/Pd-l1 Naive|URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.
11208882|NCT02253992|OG002|Outcome|TRT D - Melanoma pd1/Pd-l1 Experienced|URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced
11208883|NCT02253992|OG003|Outcome|TRT A - Melanoma pd1/Pd-l1 Naive|URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
11208884|NCT02253992|OG004|Outcome|TRT B -|URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
11208885|NCT02253992|OG005|Outcome|TRT D - Melanoma pd1/Pd-l1 Naive|URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
11208886|NCT02253992|OG006|Outcome|TRT A - SCCHN|URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
11208887|NCT02253992|OG007|Outcome|TRT D - SCCHN|URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
11208888|NCT02253992|OG008|Outcome|TRT A - Other Solid Tumors|URE3 Q4WK+NIV3 Q2WK - Other solid tumors
11208889|NCT02253992|OG009|Outcome|TRT B - Other Solid Tumors|URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
11208890|NCT02253992|OG010|Outcome|TRT D - DLBCL|URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
11208891|NCT02253992|OG011|Outcome|TRT D - FL|URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
11208892|NCT02253992|OG000|Outcome|Urelumab ADA|Urelumab Anti drug antibody
11208893|NCT02253992|OG001|Outcome|Nivolumab ADA|Nivolumab anti drug antibody
11208894|NCT02253992|EG000|Reported Event|TRT A|URE3 Q4WK+NIV3 Q2WK
11208895|NCT02253992|EG001|Reported Event|TRT B|URE8 Q4WK+NIV3 Q2WK
11208896|NCT02253992|EG002|Reported Event|TRT D|URE8 Q4WK+NIV240mg Q2WK
11208897|NCT02254252|BG000|Baseline|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
11208898|NCT02254252|BG001|Baseline|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
11208899|NCT02254252|BG002|Baseline|Total|Total of all reporting groups
11208900|NCT02254252|FG000|Participant Flow|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
11208901|NCT02254252|FG001|Participant Flow|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
11208902|NCT02254252|OG000|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
11208903|NCT02254252|OG001|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
11208904|NCT02254252|EG000|Reported Event|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
11208905|NCT02254252|EG001|Reported Event|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
11208906|NCT02254265|BG000|Baseline|OTX-101 0.05%|"OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution"
11208907|NCT02254265|BG001|Baseline|OTX-101 0.09%|"OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution"
11208908|NCT02254265|BG002|Baseline|Vehicle|"Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days~Vehicle: Vehicle of OTX-101 Ophthalmic Solution"
11208909|NCT02254265|BG003|Baseline|Total|Total of all reporting groups
11208910|NCT02254265|FG000|Participant Flow|OTX-101 0.05%|"OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution"
11208911|NCT02254265|FG001|Participant Flow|OTX-101 0.09%|"OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution"
11208912|NCT02254265|FG002|Participant Flow|Vehicle|"Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days~Vehicle: Vehicle of OTX-101 Ophthalmic Solution"
11208913|NCT02254265|OG000|Outcome|OTX-101 0.05%|"OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution"
11208914|NCT02254265|OG001|Outcome|OTX-101 0.09%|"OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution"
11208915|NCT02254265|OG002|Outcome|Vehicle|"Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days~Vehicle: Vehicle of OTX-101 Ophthalmic Solution"
11208916|NCT02254265|EG000|Reported Event|OTX-101 0.09%|"OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution"
11208917|NCT02254265|EG001|Reported Event|OTX-101 0.05%|"OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days~OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution"
11208918|NCT02254265|EG002|Reported Event|Vehicle|"Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days~Vehicle: Vehicle of OTX-101 Ophthalmic Solution"
11208919|NCT02254291|BG000|Baseline|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208920|NCT02254291|BG001|Baseline|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208921|NCT02254291|BG002|Baseline|Sitagliptin|The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208922|NCT02254291|BG003|Baseline|Total|Total of all reporting groups
11208923|NCT02254291|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208924|NCT02254291|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208925|NCT02254291|FG002|Participant Flow|Sitagliptin|The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208926|NCT02254291|OG000|Outcome|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208927|NCT02254291|OG001|Outcome|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208928|NCT02254291|OG002|Outcome|Sitagliptin|The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11244399|NCT02510794|OG003|Outcome|Intravitreal Injection With Ranibizumab 0.5mg|Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11208929|NCT02254291|EG000|Reported Event|Semaglutide 0.5 mg|Subjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208930|NCT02254291|EG001|Reported Event|Semaglutide 1.0 mg|Subjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208931|NCT02254291|EG002|Reported Event|Sitagliptin|The subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial.
11208932|NCT02254304|BG000|Baseline|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208933|NCT02254304|BG001|Baseline|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208934|NCT02254304|BG002|Baseline|Total|Total of all reporting groups
11208935|NCT02254304|FG000|Participant Flow|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208936|NCT02254304|FG001|Participant Flow|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208937|NCT02254304|OG000|Outcome|Rebif In RMS Subjects|Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208938|NCT02254304|OG000|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208939|NCT02254304|OG001|Outcome|Rebif in CIS Subjects|Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208940|NCT02254304|OG000|Outcome|Rebif In RMS and CIS Subjects|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208941|NCT02254304|OG000|Outcome|Rebif|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208942|NCT02254304|EG000|Reported Event|Rebif|Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
11208943|NCT02254408|BG000|Baseline|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) administered as a single dose, orally or via NG tube on Days 1, 5, 9, 13, and 17
11208944|NCT02254408|BG001|Baseline|Placebo|Placebo administered orally or via NG tube on Days 1, 5, 9, 13, and 17
11208945|NCT02254408|BG002|Baseline|Total|Total of all reporting groups
11208946|NCT02254408|FG000|Participant Flow|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) administered as a single dose, orally or via nasogastric (NG) tube on Days 1, 5, 9, 13, and 17
11208947|NCT02254408|FG001|Participant Flow|Placebo|Placebo administered orally or via NG tube on Days 1, 5, 9, 13, and 17
11208948|NCT02254408|OG000|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) administered as a single dose, orally or via NG tube on Days 1, 5, 9, 13, and 17
11208949|NCT02254408|OG001|Outcome|Placebo|Placebo administered orally or via NG tube on Days 1, 5, 9, 13, and 17
11208950|NCT02254408|EG000|Reported Event|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) administered as a single dose, orally or via NG tube on Days 1, 5, 9, 13, and 17
11208951|NCT02254408|EG001|Reported Event|Placebo|Placebo administered orally or via NG tube on Days 1, 5, 9, 13, and 17
11208952|NCT02254421|BG000|Baseline|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208953|NCT02254421|BG001|Baseline|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208954|NCT02254421|BG002|Baseline|Total|Total of all reporting groups
11208955|NCT02254421|FG000|Participant Flow|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208956|NCT02254421|FG001|Participant Flow|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208957|NCT02254421|OG000|Outcome|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208958|NCT02254421|OG001|Outcome|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208959|NCT02254421|EG000|Reported Event|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208960|NCT02254421|EG001|Reported Event|Placebo|Placebo tablets on Days 1, 5, 9, 13, and 17 administered orally or via nasogastric tube
11208961|NCT02254460|BG000|Baseline|Overall|Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208962|NCT02254460|FG000|Participant Flow|Test Followed by Control|Patients first received micronutrient fortified nutritional beverage powder (test) and then energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 grams (g) individual sachets, administered as a single serve in a total volume of 100 milliliters (mL) lukewarm milk for oral consumption. 1mL solution containing 3 milligrams/milliliters (mg/mL) of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage
11208963|NCT02254460|FG001|Participant Flow|Control Follwed by Test|Patients first received energy, iron and calcium equivalent beverage powder without micronutrient fortification (control) and then micronutrient fortified nutritional beverage powder (test), packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208964|NCT02254460|OG000|Outcome|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208965|NCT02254460|OG001|Outcome|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption.1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208966|NCT02254460|EG000|Reported Event|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208967|NCT02254460|EG001|Reported Event|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe, 58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
11208968|NCT02254473|BG000|Baseline|Wedge Insert|"Patients will receive a wedge insert~Wedge Insert"
11208969|NCT02254473|BG001|Baseline|Flat Insert|"Patients will receive a flat insert~Flat Insert"
11208970|NCT02254473|BG002|Baseline|Total|Total of all reporting groups
11208971|NCT02254473|FG000|Participant Flow|Wedge Insert|"Patients will receive a wedge insert~Wedge Insert"
11208972|NCT02254473|FG001|Participant Flow|Flat Insert|"Patients will receive a flat insert~Flat Insert"
10848034|NCT00287716|OG001|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
11208973|NCT02254473|OG000|Outcome|Wedge Insert|"Patients will receive a wedge insert~Wedge Insert"
11208974|NCT02254473|OG001|Outcome|Flat Insert|"Patients will receive a flat insert~Flat Insert"
11208975|NCT02254473|EG000|Reported Event|Wedge Insert|"Patients will receive a wedge insert~Wedge Insert"
11208976|NCT02254473|EG001|Reported Event|Flat Insert|"Patients will receive a flat insert~Flat Insert"
11208977|NCT02254486|BG000|Baseline|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208978|NCT02254486|BG001|Baseline|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208979|NCT02254486|BG002|Baseline|Total|Total of all reporting groups
11208980|NCT02254486|FG000|Participant Flow|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208981|NCT02254486|FG001|Participant Flow|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208982|NCT02254486|OG000|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208983|NCT02254486|OG001|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208984|NCT02254486|EG000|Reported Event|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
10848035|NCT00287716|OG002|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
10848036|NCT00287716|EG000|Reported Event|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
10848037|NCT00287716|EG001|Reported Event|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
11208985|NCT02254486|EG001|Reported Event|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
11208986|NCT02254551|BG000|Baseline|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
11208987|NCT02254551|FG000|Participant Flow|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
11208988|NCT02254551|OG000|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity"
11208989|NCT02254551|OG000|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
11208990|NCT02254551|EG000|Reported Event|Cohort 1: LDE225 400mg/m^2|"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
11208991|NCT02254551|EG001|Reported Event|Cohort 2: LDE225 600mg/m^2|Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
11208992|NCT02254551|EG002|Reported Event|Cohort 3: LDE225 800mg/m^2|"Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
11208993|NCT02254681|BG000|Baseline|Treatment|"Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.~Gemcitabine~Cisplatin~Low dose whole liver and portal lymph node basin radiotherapy"
11208994|NCT02254681|FG000|Participant Flow|Treatment|"Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.~Gemcitabine~Cisplatin~Low dose whole liver and portal lymph node basin radiotherapy"
11208995|NCT02254681|OG000|Outcome|Treatment|"Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.~Gemcitabine~Cisplatin~Low dose whole liver and portal lymph node basin radiotherapy~decision was made to close the study due to the futility of the regimen in the first 6 subjects, as well as the lack of funding to complete the study."
11208996|NCT02254681|OG000|Outcome|Treatment|"Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.~Gemcitabine~Cisplatin~liver and portal lymph node low dose Radiotherapy"
11208997|NCT02254681|EG000|Reported Event|Treatment|"Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.~Gemcitabine~Cisplatin~Low dose whole liver and portal lymph node basin radiotherapy"
11208998|NCT02254772|BG000|Baseline|Treatment (SD-101 + Ipilimumab + Radiation)|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
11208999|NCT02254772|FG000|Participant Flow|Treatment (SD-101 + Ipilimumab + Radiation)|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
10848038|NCT00287716|EG002|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
11209000|NCT02254772|OG000|Outcome|Treatment (SD-101 + Ipilimumab + Radiation)|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
11209001|NCT02254772|EG000|Reported Event|Treatment (SD-101 + Ipilimumab + Radiation)|Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
10848039|NCT00287729|BG000|Baseline|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
10848040|NCT00287729|BG001|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
11209002|NCT02255032|BG000|Baseline|4 mg CLS-TA|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209003|NCT02255032|BG001|Baseline|0.8 mg CLS-TA|"Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA~0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209004|NCT02255032|BG002|Baseline|Total|Total of all reporting groups
11209005|NCT02255032|FG000|Participant Flow|4 mg CLS-TA|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209006|NCT02255032|FG001|Participant Flow|0.8 mg CLS-TA|"Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA~0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209007|NCT02255032|OG000|Outcome|4 mg CLS-TA|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209008|NCT02255032|OG001|Outcome|0.8 mg CLS-TA|"Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA~0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209009|NCT02255032|EG000|Reported Event|4 mg CLS-TA|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209010|NCT02255032|EG001|Reported Event|0.8 mg CLS-TA|"Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA~0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)"
11209015|NCT02255110|BG000|Baseline|TH-302 and Doxorubicin|Subjects received TH-302 at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Day 1 and 8 of every 21-day cycle and Doxorubicin at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
11209016|NCT02255110|FG000|Participant Flow|TH-302 and Doxorubicin|Subjects received TH-302 at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Day 1 and 8 of every 21-day cycle and Doxorubicin at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
11209017|NCT02255110|OG000|Outcome|TH-302 and Doxorubicin|Subjects received TH-302 at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Day 1 and 8 of every 21-day cycle and Doxorubicin at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
11209018|NCT02255110|EG000|Reported Event|TH-302 and Doxorubicin|Subjects received TH-302 at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Day 1 and 8 of every 21-day cycle and Doxorubicin at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
11209019|NCT02255149|BG000|Baseline|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
11209020|NCT02255149|FG000|Participant Flow|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
11209021|NCT02255149|OG000|Outcome|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
11209022|NCT02255149|EG000|Reported Event|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
10848041|NCT00287729|BG002|Baseline|Total|Total of all reporting groups
10848042|NCT00287729|FG000|Participant Flow|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
10848043|NCT00287729|FG001|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
10848044|NCT00287729|OG000|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
11209023|NCT02255175|BG000|Baseline|Perimenopausal Women, Depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11286216|NCT02885181|EG002|Reported Event|Filgotinib|Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
11209024|NCT02255175|BG001|Baseline|Perimenopausal Women, Non-depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209025|NCT02255175|BG002|Baseline|Total|Total of all reporting groups
11209026|NCT02255175|FG000|Participant Flow|Perimenopausal Women, Depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209027|NCT02255175|FG001|Participant Flow|Perimenopausal Women, Non-depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209028|NCT02255175|OG000|Outcome|Perimenopausal Women, Depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209029|NCT02255175|OG001|Outcome|Perimenopausal Women, Non-depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209030|NCT02255175|OG000|Outcome|Perimenopausal Women, Depressed, Baseline|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209031|NCT02255175|OG001|Outcome|Perimenopausal Women, Non-depressed, Baseline|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209032|NCT02255175|OG002|Outcome|Perimenopausal Women, Depressed, Following Estradiol Treatment|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209033|NCT02255175|OG003|Outcome|Perimenopausal Women, Non-depressed, Following Estradiol|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11286217|NCT02885181|EG003|Reported Event|Placebo|GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
10819608|NCT00048581|BG000|Baseline|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819609|NCT00048581|BG001|Baseline|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819610|NCT00048581|BG002|Baseline|Total|Total of all reporting groups
10819611|NCT00048581|FG000|Participant Flow|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819612|NCT00048581|FG001|Participant Flow|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819613|NCT00048581|FG002|Participant Flow|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
11209034|NCT02255175|EG000|Reported Event|Perimenopausal Women, Depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209035|NCT02255175|EG001|Reported Event|Perimenopausal Women, Non-depressed|"Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.~Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks~Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation."
11209036|NCT02255279|BG000|Baseline|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209037|NCT02255279|BG001|Baseline|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209038|NCT02255279|BG002|Baseline|Total|Total of all reporting groups
11209039|NCT02255279|FG000|Participant Flow|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209040|NCT02255279|FG001|Participant Flow|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209041|NCT02255279|OG000|Outcome|Naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
11209042|NCT02255279|OG001|Outcome|Naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
11209043|NCT02255279|OG000|Outcome|Non-naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
11209044|NCT02255279|OG001|Outcome|Non-naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
11209045|NCT02255279|OG000|Outcome|Naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209046|NCT02255279|OG001|Outcome|Naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209047|NCT02255279|OG000|Outcome|Non-naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
10848045|NCT00287729|OG001|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
10848046|NCT00287729|EG000|Reported Event|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
10848047|NCT00287729|EG001|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
11209048|NCT02255279|OG001|Outcome|Non-naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209049|NCT02255279|OG000|Outcome|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209050|NCT02255279|OG001|Outcome|Naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209051|NCT02255279|OG000|Outcome|Non naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209052|NCT02255279|OG001|Outcome|Non naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209053|NCT02255279|OG000|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
11209054|NCT02255279|OG001|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
11209055|NCT02255279|EG000|Reported Event|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive).
11209056|NCT02255279|EG001|Reported Event|Naive_TIV (6 Months to < 72 Months)|"A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive).~Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy."
11209057|NCT02255279|EG002|Reported Event|Non-naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive).
11209058|NCT02255279|EG003|Reported Event|Non-naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive).
11209059|NCT02255357|BG000|Baseline|Placebo|"Solution containing only the excipients of the original solution without Oxytocin.~Placebo: Solution containing only the excipients of the original solution without Oxytocin."
11209060|NCT02255357|BG001|Baseline|Intranasal Syntocinon|"Intranasal Oxytocin 24 IU per day.~Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm"
11209061|NCT02255357|BG002|Baseline|Total|Total of all reporting groups
11209062|NCT02255357|FG000|Participant Flow|Placebo|"Solution containing only the excipients of the original solution without Oxytocin.~Placebo: Solution containing only the excipients of the original solution without Oxytocin."
11209063|NCT02255357|FG001|Participant Flow|Intranasal Syntocinon|"Intranasal Oxytocin 24 IU per day.~Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm"
11209064|NCT02255357|OG000|Outcome|Placebo|"Solution containing only the excipients of the original solution without Oxytocin.~Placebo: Solution containing only the excipients of the original solution without Oxytocin."
11209065|NCT02255357|OG001|Outcome|Intranasal Syntocinon|"Intranasal Oxytocin 24 IU per day.~Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm"
11209066|NCT02255357|EG000|Reported Event|Placebo|"Solution containing only the excipients of the original solution without Oxytocin.~Placebo: Solution containing only the excipients of the original solution without Oxytocin."
11209067|NCT02255357|EG001|Reported Event|Intranasal Syntocinon|"Intranasal Oxytocin 24 IU per day.~Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm"
11209068|NCT02255422|BG000|Baseline|Placebo|Placebo capsules administered orally once daily for 12 weeks
11209069|NCT02255422|BG001|Baseline|Omaveloxolone Capsules 2.5 and 5 mg|Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
11209070|NCT02255422|BG002|Baseline|Omaveloxolone Capsules 10 mg|Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
11209071|NCT02255422|BG003|Baseline|Omaveloxolone Capsules 20 mg|Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
11209072|NCT02255422|BG004|Baseline|Omaveloxolone Capsules 40 mg|Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
11209073|NCT02255422|BG005|Baseline|Omaveloxolone Capsules 80 mg|Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
11209074|NCT02255422|BG006|Baseline|Omaveloxolone Capsules 160 mg|Omaveloxolone (RTA 408) 160 mg capsules administered once daily for 12 weeks
11209075|NCT02255422|BG007|Baseline|Total|Total of all reporting groups
11209076|NCT02255422|FG000|Participant Flow|Placebo|Placebo capsules administered orally once daily for 12 weeks
11209077|NCT02255422|FG001|Participant Flow|Omaveloxolone Capsules 2.5 and 5 mg|Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5mg administered orally once daily for 10 weeks
11209078|NCT02255422|FG002|Participant Flow|Omaveloxolone Capsules 10 mg|Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
11209079|NCT02255422|FG003|Participant Flow|Omaveloxolone Capsules 20 mg|Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
11209080|NCT02255422|FG004|Participant Flow|Omaveloxolone Capsules 40 mg|Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
11209081|NCT02255422|FG005|Participant Flow|Omaveloxolone Capsules 80 mg|Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
11209082|NCT02255422|FG006|Participant Flow|Omaveloxolone Capsules 160 mg|Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
11209083|NCT02255422|OG000|Outcome|Placebo|Placebo capsules administered orally once daily for 12 weeks
11209084|NCT02255422|OG001|Outcome|Omaveloxolone Capsules 2.5 and 5 mg|Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
11209085|NCT02255422|OG002|Outcome|Omaveloxolone Capsules 10 mg|Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
11209086|NCT02255422|OG003|Outcome|Omaveloxolone Capsules 20 mg|Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
11209087|NCT02255422|OG004|Outcome|Omaveloxolone Capsules 40 mg|Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
11209088|NCT02255422|OG005|Outcome|Omaveloxolone Capsules 80 mg|Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
11209089|NCT02255422|OG006|Outcome|Omaveloxolone Capsules 160 mg|Omaveloxolone (RTA 408) 160 mg capsules administered once daily for 12 weeks
11209090|NCT02255422|EG000|Reported Event|Placebo|Placebo capsules administered orally once daily for 12 weeks
11209091|NCT02255422|EG001|Reported Event|Omaveloxolone Capsules 2.5 and 5 mg|Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
11209092|NCT02255422|EG002|Reported Event|Omaveloxolone Capsules 10 mg|Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
11209093|NCT02255422|EG003|Reported Event|Omaveloxolone Capsules 20 mg|Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
11209094|NCT02255422|EG004|Reported Event|Omaveloxolone Capsules 40 mg|Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
11209095|NCT02255422|EG005|Reported Event|Omaveloxolone Capsules 80 mg|Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
11209096|NCT02255422|EG006|Reported Event|Omaveloxolone Capsules 160 mg|Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
11209097|NCT02255461|BG000|Baseline|Stratum I, Dose Level 1 (50 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209098|NCT02255461|BG001|Baseline|Stratum I, Dose Level 2 (75 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209099|NCT02255461|BG002|Baseline|Stratum I, Dose Level 3 (95 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209100|NCT02255461|BG003|Baseline|Stratum II, Dose Level 1 (50 mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209101|NCT02255461|BG004|Baseline|Stratum II, Dose Level 2 (75mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209102|NCT02255461|BG005|Baseline|Total|Total of all reporting groups
11209103|NCT02255461|FG000|Participant Flow|Stratum I, Dose Level 1 (50 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209104|NCT02255461|FG001|Participant Flow|Stratum I, Dose Level 2 (75 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209105|NCT02255461|FG002|Participant Flow|Stratum I, Dose Level 3 (95 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209106|NCT02255461|FG003|Participant Flow|Stratum II, Dose Level 1 (50 mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209107|NCT02255461|FG004|Participant Flow|Stratum II, Dose Level 2 (75mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209108|NCT02255461|OG000|Outcome|Stratum I|Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.
11209109|NCT02255461|OG000|Outcome|Stratum II|Of 14 patients enrolled on stratum II, 3 patients were not evaluable for dose finding assessment: 2 patients due to receiving less than required dose of study drug and 1 due to withdrawal consent prior to beginning protocol therapy. The remaining 11 patients were used to determine the MTD for stratum II.
11209110|NCT02255461|OG000|Outcome|Stratum I, Dose Level 1 (50 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209111|NCT02255461|OG001|Outcome|Stratum I, Dose Level 2 (75 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209112|NCT02255461|OG002|Outcome|Stratum I, Dose Level 3 (95 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209113|NCT02255461|OG003|Outcome|Stratum II, Dose Level 1 (50 mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209114|NCT02255461|OG004|Outcome|Stratum II, Dose Level 2 (75mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209115|NCT02255461|OG000|Outcome|All Patients|All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no neutropenia (n = 9), grade 1 or 2 neutropenia (n = 7), and grade 3 or 4 neutropenia (n = 18).
11209116|NCT02255461|OG000|Outcome|All Patients|All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no lymphopenia (n = 17), grade 1 or 2 lymphopenia (n = 10), and grade 3 or 4 lymphopenia (n = 7).
11209117|NCT02255461|OG000|Outcome|All Patients|All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no leukopenia (n = 8), grade 1 or 2 leukopenia (n = 17), and grade 3 or 4 leukopenia (n = 9).
11209118|NCT02255461|EG000|Reported Event|Stratum I, Dose Level 1 (50 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209119|NCT02255461|EG001|Reported Event|Stratum I, Dose Level 2 (75 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209120|NCT02255461|EG002|Reported Event|Stratum I, Dose Level 3 (95 mg/m2)|Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209121|NCT02255461|EG003|Reported Event|Stratum II, Dose Level 1 (50 mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209122|NCT02255461|EG004|Reported Event|Stratum II, Dose Level 2 (75mg/m2)|Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
11209123|NCT02255474|BG000|Baseline|Biofinity|Single vision soft contact lens
11209124|NCT02255474|BG001|Baseline|Biofinity +1.50 D Add|Medium add soft bifocal contact lens (+1.50 Diopter add)
11209125|NCT02255474|BG002|Baseline|Biofinity +2.50 D Add|High add soft bifocal contact lens (+2.50 Diopter add)
11209126|NCT02255474|BG003|Baseline|Total|Total of all reporting groups
11209127|NCT02255474|FG000|Participant Flow|Biofinity|"Soft spherical contact lens~Biofinity: This is a monthly disposable spherical contact lens commercially available from CooperVision"
11209128|NCT02255474|FG001|Participant Flow|Biofinity Multifocal D +1.50 Add|"The Biofinity Multifocal D with a +1.50 add is a soft bifocal contact lens that has a medium reading power~Biofinity Multifocal D +1.50 add: This is a monthly disposable contact lens commercially available from CooperVision"
11209129|NCT02255474|FG002|Participant Flow|Biofinity Multifocal D +2.50 Add|"The Biofinity Multifocal D with a +2.50 add is a soft bifocal contact lens that has a strong reading power~Biofinity Multifocal D +2.50 add: This is a monthly disposable contact lens commercially available from CooperVision"
11209130|NCT02255474|OG000|Outcome|Biofinity|Spherical soft contact lens
11209131|NCT02255474|OG001|Outcome|Biofinity +1.50 D Add|Medium add soft bifocal contact lens (+1.50 Diopter add)
11209132|NCT02255474|OG002|Outcome|Biofinity +2.50 D Add|High add soft bifocal contact lens (+2.50 Diopter add)
11209133|NCT02255474|OG000|Outcome|Biofinity|Single vision soft contact lens
11209134|NCT02255474|EG000|Reported Event|Biofinity|Spherical soft contact lens
11209135|NCT02255474|EG001|Reported Event|Biofinity +1.50 D Add|Medium add soft bifocal contact lens (+1.50 Diopter add)
11209136|NCT02255474|EG002|Reported Event|Biofinity +2.50 D Add|High add soft bifocal contact lens (+2.50 Diopter add)
11209137|NCT02255500|BG000|Baseline|Bupivacaine FNB + EXPAREL Infiltration|"FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.~Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.~EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure."
11209138|NCT02255500|BG001|Baseline|Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine|"Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.~Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from Bupivacaine FNB + EXPAREL Infiltration."
11209139|NCT02255500|BG002|Baseline|Total|Total of all reporting groups
11209140|NCT02255500|FG000|Participant Flow|Bupivacaine FNB + EXPAREL Infiltration|"Femoral nerve block with bupivacaine hydrochloride (HCl) 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.~Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.~EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure."
11209141|NCT02255500|FG001|Participant Flow|Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine|"Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.~Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from Bupivacaine FNB + EXPAREL Infiltration."
11209142|NCT02255500|OG000|Outcome|Bupivacaine FNB + EXPAREL Infiltration|"FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.~Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.~EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure."
11209143|NCT02255500|OG001|Outcome|Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine|"Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.~Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from Bupivacaine FNB + EXPAREL Infiltration."
11209144|NCT02255500|EG000|Reported Event|Bupivacaine FNB + EXPAREL Infiltration|"FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.~Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.~EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure."
11209145|NCT02255500|EG001|Reported Event|Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine|"Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.~Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.~EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 infiltrated into the surgical site just prior to wound closure."
11209146|NCT02255513|BG000|Baseline|HLD200|Double-blind, optimal dose of HLD200 for 7 days
11209147|NCT02255513|BG001|Baseline|Placebo|Double-blind, placebo for 7 days
11209148|NCT02255513|BG002|Baseline|Total|Total of all reporting groups
11209149|NCT02255513|FG000|Participant Flow|HLD200|"HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules~Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening."
11209150|NCT02255513|FG001|Participant Flow|Placebo|"Placebo capsules (dose matched to HLD200 capsules)~Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening."
11209151|NCT02255513|OG000|Outcome|HLD200|Double-blind, optimal dose of HLD200 for 7 days
11209152|NCT02255513|OG001|Outcome|Placebo|Double-blind, placebo for 7 days
11209153|NCT02255513|EG000|Reported Event|HLD200|Double-blind, optimal dose of HLD200 for 7 days
11209154|NCT02255513|EG001|Reported Event|Placebo|Double-blind, placebo for 7 days
11209155|NCT02255552|BG000|Baseline|Eteplirsen 30 mg/kg|Participants with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to treatment by exon 51 skipping received Eteplirsen as an Intravenous (IV) infusion, at a dose of 30 milligram per kilogram (mg/kg) once weekly for 96 weeks.
11209156|NCT02255552|BG001|Baseline|Untreated Control Group (Non-exon 51 Amenable Participants)|DMD participants with mutations amenable to skipping of any exon(s) except exon 51 did not receive any treatment, but completed study assessments up to 96 weeks.
11209157|NCT02255552|BG002|Baseline|Total|Total of all reporting groups
11209158|NCT02255552|FG000|Participant Flow|Eteplirsen 30 mg/kg|Participants with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to treatment by exon 51 skipping received Eteplirsen as an Intravenous (IV) infusion, at a dose of 30 milligram per kilogram (mg/kg) once weekly for 96 weeks.
11209159|NCT02255552|FG001|Participant Flow|Untreated Control Group (Non-exon 51 Amenable Participants)|DMD participants with mutations amenable to skipping of any exon(s) except exon 51 did not receive any treatment, but completed study assessments up to 96 weeks.
11209160|NCT02255552|OG000|Outcome|Eteplirsen 30 mg/kg|Participants with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to treatment by exon 51 skipping received Eteplirsen as an Intravenous (IV) infusion, at a dose of 30 milligram per kilogram (mg/kg) once weekly for 96 weeks.
11209161|NCT02255552|OG001|Outcome|Untreated Control Group (Non-exon 51 Amenable Participants)|DMD participants with mutations amenable to skipping of any exon(s) except exon 51 did not receive any treatment, but completed study assessments up to 96 weeks.
11209162|NCT02255552|EG000|Reported Event|Eteplirsen 30 mg/kg|Participants with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to treatment by exon 51 skipping received Eteplirsen as an Intravenous (IV) infusion, at a dose of 30 milligram per kilogram (mg/kg) once weekly for 96 weeks.
11209163|NCT02255552|EG001|Reported Event|Untreated Control Group (Non-exon 51 Amenable Participants)|DMD participants with mutations amenable to skipping of any exon(s) except exon 51 did not receive any treatment, but completed study assessments up to 96 weeks.
11209164|NCT02255565|BG000|Baseline|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209165|NCT02255565|BG001|Baseline|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209166|NCT02255565|BG002|Baseline|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209167|NCT02255565|BG003|Baseline|Total|Total of all reporting groups
11209168|NCT02255565|FG000|Participant Flow|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209169|NCT02255565|FG001|Participant Flow|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209170|NCT02255565|FG002|Participant Flow|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209171|NCT02255565|OG000|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209172|NCT02255565|OG001|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209173|NCT02255565|OG002|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209174|NCT02255565|OG003|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11286218|NCT02885246|BG000|Baseline|Influenza Virus Positive Group|The group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017.
10848048|NCT00287872|BG000|Baseline|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
11209175|NCT02255565|OG004|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209176|NCT02255565|OG005|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209177|NCT02255565|OG006|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209178|NCT02255565|OG007|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209179|NCT02255565|OG008|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209180|NCT02255565|OG009|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209181|NCT02255565|OG010|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209182|NCT02255565|OG011|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209183|NCT02255565|OG012|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209184|NCT02255565|OG013|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209185|NCT02255565|OG014|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209186|NCT02255565|OG015|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209187|NCT02255565|OG016|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
10848049|NCT00287872|FG000|Participant Flow|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
10848050|NCT00287872|OG000|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
11209188|NCT02255565|OG017|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209189|NCT02255565|OG006|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209190|NCT02255565|OG007|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209191|NCT02255565|OG008|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209192|NCT02255565|OG009|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209193|NCT02255565|OG010|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209194|NCT02255565|OG011|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209195|NCT02255565|OG012|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209196|NCT02255565|OG013|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209197|NCT02255565|OG014|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209198|NCT02255565|OG015|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209199|NCT02255565|OG016|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209200|NCT02255565|OG017|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209201|NCT02255565|OG000|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209202|NCT02255565|OG001|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209203|NCT02255565|OG002|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209204|NCT02255565|OG003|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209205|NCT02255565|OG004|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209206|NCT02255565|OG005|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209207|NCT02255565|EG000|Reported Event|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
11209208|NCT02255565|EG001|Reported Event|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
11209209|NCT02255565|EG002|Reported Event|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
11209210|NCT02255604|BG000|Baseline|Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.~Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4"
11209211|NCT02255604|BG001|Baseline|3 Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.~alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode"
11209212|NCT02255604|BG002|Baseline|no Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.~0.1 ml Isoton saline: 4 injection into a lymphnode"
11209213|NCT02255604|BG003|Baseline|Total|Total of all reporting groups
11209214|NCT02255604|FG000|Participant Flow|Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.~Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4"
11209215|NCT02255604|FG001|Participant Flow|3 Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.~alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode"
11209216|NCT02255604|FG002|Participant Flow|no Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.~0.1 ml Isoton saline: 4 injection into a lymphnode"
11209217|NCT02255604|OG000|Outcome|Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.~Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4"
11209218|NCT02255604|OG001|Outcome|3 Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.~alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode"
11209219|NCT02255604|OG002|Outcome|no Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.~0.1 ml Isoton saline: 4 injection into a lymphnode"
11209220|NCT02255604|EG000|Reported Event|Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.~Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4"
11209221|NCT02255604|EG001|Reported Event|3 Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.~Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.~alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode"
11209222|NCT02255604|EG002|Reported Event|no Intralymphatic Immune Therapy|"Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.~Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.~0.1 ml Isoton saline: 4 injection into a lymphnode"
11209223|NCT02255760|BG000|Baseline|Placebo|Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
11209224|NCT02255760|BG001|Baseline|MEDI3902 - Dose 1|Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
11209225|NCT02255760|BG002|Baseline|MEDI3902 - Dose 2|Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
11209226|NCT02255760|BG003|Baseline|MEDI3902 - Dose 3|Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
11209227|NCT02255760|BG004|Baseline|MEDI3902 - Dose 4|Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
11209228|NCT02255760|BG005|Baseline|Total|Total of all reporting groups
10848051|NCT00287872|OG000|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib thalidomide"
11209229|NCT02255760|FG000|Participant Flow|Placebo|Participants received a single dose of placebo by intravenous (IV) infusion up to a maximum of 12 hours.
11209230|NCT02255760|FG001|Participant Flow|MEDI3902 - Dose 1|Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
11209231|NCT02255760|FG002|Participant Flow|MEDI3902 - Dose 2|Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
11209232|NCT02255760|FG003|Participant Flow|MEDI3902 - Dose 3|Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
11209233|NCT02255760|FG004|Participant Flow|MEDI3902 - Dose 4|Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
11209234|NCT02255760|OG000|Outcome|Placebo|Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
11209235|NCT02255760|OG001|Outcome|MEDI3902 - Dose 1|Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
11209236|NCT02255760|OG002|Outcome|MEDI3902 - Dose 2|Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
11209237|NCT02255760|OG003|Outcome|MEDI3902 - Dose 3|Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
11209238|NCT02255760|OG004|Outcome|MEDI3902 - Dose 4|Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
11209239|NCT02255760|OG000|Outcome|MEDI3902 - Dose 1|Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
11209240|NCT02255760|OG001|Outcome|MEDI3902 - Dose 2|Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
11209241|NCT02255760|OG002|Outcome|MEDI3902 - Dose 3|Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
11209242|NCT02255760|OG003|Outcome|MEDI3902 - Dose 4|Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
11209243|NCT02255760|EG000|Reported Event|Placebo|Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
10848052|NCT00287872|EG000|Reported Event|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
10848053|NCT00287989|BG000|Baseline|150 PRE|Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
11209244|NCT02255760|EG001|Reported Event|MEDI3902 - Dose 1|Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
11209245|NCT02255760|EG002|Reported Event|MEDI3902 - Dose 2|Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
11209246|NCT02255760|EG003|Reported Event|MEDI3902 - Dose 3|Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
11209247|NCT02255760|EG004|Reported Event|MEDI3902 - Dose 4|Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
11209248|NCT02255981|BG000|Baseline|Acupuncture & Macular Damage|"Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself~.~Acupuncture Traditional Chinese Medicine (TCM): Treatment consist in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement."
11209249|NCT02255981|FG000|Participant Flow|Acupuncture & Macular Damage|"Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself~.~Acupuncture Traditional Chinese Medicine (TCM): Treatment consist in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement."
11209250|NCT02255981|OG000|Outcome|Change in VA From Baseline to the End of Study|There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together
11209251|NCT02255981|OG000|Outcome|VA Measured at Snellen Chart at the Beginning of the Study|In all participants, VA was measured at baseline. The category of visual impairment according to WHO, ICD-10 is presented below.
11209252|NCT02255981|OG001|Outcome|VA Measured at Snellen Chart at the End of the Study|VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
11209253|NCT02255981|OG000|Outcome|All Eyes Which Received Acupunture for 24 Months|"The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used.~There were 22 eyes diagnosed with NV AMD, 23 eyes with no NV AMD, 8 eyes with macular dystrophy, and 3 eyes with Myopic degeneration. 2 eyes of all participants were excluded due to its status, one blind and one with retinal detachment. Although the observation collected the data for each macular disease form, the objective of the trial was not to compare between types of the disease and the results are grouped for the total of eyes."
11209254|NCT02255981|OG000|Outcome|Acupuncture Group Eyes With NV AMD|"Patients with neovascular membrane treated with Acupuncture and massage who improved vision (AV).~Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months~Acupuncture has been used for retinal diseases in hospitals of China and in other parts of the world. Some patients in this study had one or both eyes with AMD classified as Neovascular AMD by OCT and retinologist examination. In this group were analyzed 22 eyes of 13 patients, Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.~Periocular massage is taught and is practiced daily by the patient him or herself."
11209255|NCT02255981|OG000|Outcome|Acupuncture Group|"Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months~Acupuncture and massage: Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement. A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.~Periocular massage is taught and is practiced daily by the patient him or herself."
11209256|NCT02255981|OG000|Outcome|Adverse Events|"By law, and by the protocol of study the adverse events were monitored. In acupuncture, the risks are not frequent and mainly they can consist of pain in the site of insertion of the needle, minimal bleeding or ecchymosis.~When the observed adverse events exceed the expectations, should have been reported, i.e., moderate to severe pain, bleeding that is more than a drop, or ecchymosis bigger than 5 millimeters in diameter.~Similarly, was monitored any trouble related or not with the treatment as serious adverse events and mortality."
11209257|NCT02255981|EG000|Reported Event|All Study Participants|Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion plus Periocular massage.
10848054|NCT00287989|BG001|Baseline|1,500 PRE|Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
11209258|NCT02256072|BG000|Baseline|Plan Your Lifespan Website|"Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
11209259|NCT02256072|BG001|Baseline|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
11209260|NCT02256072|BG002|Baseline|Total|Total of all reporting groups
11209261|NCT02256072|FG000|Participant Flow|Plan Your Lifespan Website|Participants in the intervention arm will navigate PlanYourLifespan.org.
11209262|NCT02256072|FG001|Participant Flow|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
11209263|NCT02256072|OG000|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
11209264|NCT02256072|OG001|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
11209265|NCT02256072|OG000|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making."
11209266|NCT02256072|EG000|Reported Event|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website."
11244400|NCT02510794|OG003|Outcome|Ranibizumab PD All Participants|Participants had the Implant (prefilled with approximately 20 μL either the 10 mg/mL [approximately 0.2 mg dose], 40 mg/mL [approximately 0.8 mg dose], or 100 mg/mL formulation [approximately 2-mg dose] of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10 mg/mL, 40 mg/mL, or 100 mg/mL formulations of ranibizumab according to their randomization as per protocol-specified refill criteria.
10819614|NCT00048581|OG000|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819615|NCT00048581|OG001|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819616|NCT00048581|OG000|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
10819617|NCT00048581|OG000|Outcome|All Treated DB Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819618|NCT00048581|OG000|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819619|NCT00048581|OG001|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819620|NCT00048581|OG000|Outcome|OL: ABA|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819621|NCT00048581|OG000|Outcome|All Treated Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819622|NCT00048581|EG000|Reported Event|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
10819623|NCT00048581|EG001|Reported Event|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
10819624|NCT00048581|EG002|Reported Event|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
10819625|NCT00048724|BG000|Baseline|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
10819626|NCT00048724|BG001|Baseline|Untreated Control|
10819627|NCT00048724|BG002|Baseline|Total|Total of all reporting groups
10819628|NCT00048724|FG000|Participant Flow|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
10819629|NCT00048724|FG001|Participant Flow|Untreated Control|
10819630|NCT00048724|OG000|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
10819631|NCT00048724|OG001|Outcome|Untreated Control|
10819632|NCT00048724|EG000|Reported Event|PegIntron|
10819633|NCT00048724|EG001|Reported Event|Untreated Control|
10848055|NCT00287989|BG002|Baseline|1,500 POST|Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
10848056|NCT00287989|BG003|Baseline|Total|Total of all reporting groups
11209267|NCT02256072|EG001|Reported Event|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
11209268|NCT02256111|BG000|Baseline|ENZ+ADT+Usual Care|"The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.~Enzalutamide~Androgen deprivation therapy"
11209269|NCT02256111|BG001|Baseline|ENZ+ADT+Exercise|"The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.~Enzalutamide~Androgen deprivation therapy~Supervised exercise training"
11209270|NCT02256111|BG002|Baseline|Total|Total of all reporting groups
11209271|NCT02256111|FG000|Participant Flow|ENZ+ADT+Usual Care|"The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.~Enzalutamide~Androgen deprivation therapy"
11209272|NCT02256111|FG001|Participant Flow|ENZ+ADT+Exercise|"The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.~Enzalutamide~Androgen deprivation therapy~Supervised exercise training"
11209273|NCT02256111|OG000|Outcome|ENZ+ADT+Usual Care|"The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.~Enzalutamide~Androgen deprivation therapy"
11209274|NCT02256111|OG001|Outcome|ENZ+ADT+Exercise|"The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.~Enzalutamide~Androgen deprivation therapy~Supervised exercise training"
11209275|NCT02256111|OG000|Outcome|Approached Subjects|"The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.~Enzalutamide~Androgen deprivation therapy"
11209276|NCT02256111|EG000|Reported Event|ENZ+ADT+Usual Care|"The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.~Enzalutamide~Androgen deprivation therapy"
11209277|NCT02256111|EG001|Reported Event|ENZ+ADT+Exercise|"The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.~Enzalutamide~Androgen deprivation therapy~Supervised exercise training"
11209278|NCT02256189|BG000|Baseline|Sitagliptin First, Then Placebo|"Hypoglycemia clamp with sitagliptin~Sitagliptin: Treatment with sitagliptin 100mg QD for four weeks followed by hyperinsulinemic hypoglycemic clamp"
11209279|NCT02256189|BG001|Baseline|Placebo First, Then Stagliptin|"Hypoglycemia clamp with placebo~Placebo: Treatment with placebo QD for four weeks followed by hyperinsulinemic hypoglycemic clamp"
11209280|NCT02256189|BG002|Baseline|Total|Total of all reporting groups
11209281|NCT02256189|FG000|Participant Flow|Sitagliptin First, Then Placebo|Sitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks
11209282|NCT02256189|FG001|Participant Flow|Placebo First, Then Sitagliptin|Placebo first for four weeks, then washout for four weeks, then placebo for four weeks
11209283|NCT02256189|OG000|Outcome|Sitagliptin|"Hypoglycemia clamp with sitagliptin~Sitagliptin: Treatment with sitagliptin 100mg QD for four weeks followed by hyperinsulinemic hypoglycemic clamp"
11209284|NCT02256189|OG001|Outcome|Placebo|"Hypoglycemia clamp with placebo~Placebo: Treatment with placebo QD for four weeks followed by hyperinsulinemic hypoglycemic clamp"
11209285|NCT02256189|EG000|Reported Event|Sitagliptin First, Then Placebo|Sitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks
11209286|NCT02256189|EG001|Reported Event|Placebo First, Then Stagliptin|Placebo first for four weeks, then washout for four weeks, then sitalgiptin for four weeks
11209287|NCT02256189|EG002|Reported Event|Sitagliptin|Sitagliptin 100mg Daily for four weeks, either before or after a 4 week placebo period
11209288|NCT02256189|EG003|Reported Event|Placebo|Placebo Daily for four weeks, efter before or after a 4 week sitagliptin period
11209289|NCT02256267|BG000|Baseline|LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin|Single oral dose of 200 mg LY2835219 on Day 1 in Period 1. Day 2 through Day 9 in Period 1 is washout. QD doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.
11209290|NCT02256267|FG000|Participant Flow|LY2835219 Then LY2835219 + Rifampin|Single oral dose of 200 milligrams (mg) LY2835219 on Day 1 in Period 1. Once daily (QD) doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.Single oral dose of 200 mg of LY2835219 with 600 mg Rifampin orally, QD on Day 7 in Period 2. QD doses of 600 mg Rifampin was continued for 7 days in Period 2 after coadministration with LY2835219 dose.
11209291|NCT02256267|OG000|Outcome|200 mg LY2835219|Single oral dose of 200 mg LY2835219
11209292|NCT02256267|OG001|Outcome|200 mg LY2835219 + 600 mg Rifampin|Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD for 14 days
11209293|NCT02256267|EG000|Reported Event|LY2835219|Single oral dose of 200 mg LY2835219 Day 1, period 1.
11209294|NCT02256267|EG001|Reported Event|Rifampin|Single oral, QD doses of 600 mg of Rifampin for 6 days Day 1 to Day 6 in period 2
11209295|NCT02256267|EG002|Reported Event|LY2835219 + Rifampin|Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD on Day 7 of period 2.
11209296|NCT02256345|BG000|Baseline|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
11209297|NCT02256345|BG001|Baseline|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
11209298|NCT02256345|BG002|Baseline|Total|Total of all reporting groups
10848057|NCT00287989|FG000|Participant Flow|150 PRE|Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
11209299|NCT02256345|FG000|Participant Flow|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated.~Active Comparator: Potassium Nitrate (KNO3)"
10848058|NCT00287989|FG001|Participant Flow|1,500 PRE|Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
10848059|NCT00287989|FG002|Participant Flow|1,500 POST|Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
11209300|NCT02256345|FG001|Participant Flow|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated.~Placebo Comparator: Potassium Chloride (KCl)"
11209301|NCT02256345|OG000|Outcome|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
10819634|NCT00048737|BG000|Baseline|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
10819635|NCT00048737|FG000|Participant Flow|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
10819636|NCT00048737|OG000|Outcome|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab: 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
10819637|NCT00048737|EG000|Reported Event|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
10819638|NCT00048815|BG000|Baseline|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
10819639|NCT00048815|BG001|Baseline|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
11209302|NCT02256345|OG001|Outcome|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
11209303|NCT02256345|EG000|Reported Event|Randomized to KNO3|"KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated~Active Comparator: Potassium Nitrate"
11209304|NCT02256345|EG001|Reported Event|Randomized to KCl|"KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if tolerating well.~Placebo Comparator: Potassium Chloride"
11209305|NCT02256358|BG000|Baseline|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
11209306|NCT02256358|BG001|Baseline|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
11209307|NCT02256358|BG002|Baseline|Total|Total of all reporting groups
11209308|NCT02256358|FG000|Participant Flow|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
10819640|NCT00048815|BG002|Baseline|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
10819641|NCT00048815|BG003|Baseline|Total|Total of all reporting groups
10819642|NCT00048815|FG000|Participant Flow|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
10819643|NCT00048815|FG001|Participant Flow|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
10819644|NCT00048815|FG002|Participant Flow|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
10819645|NCT00048815|OG000|Outcome|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
10819646|NCT00048815|OG001|Outcome|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
11209309|NCT02256358|FG001|Participant Flow|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
10819647|NCT00048815|OG002|Outcome|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
10819648|NCT00048815|EG000|Reported Event|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
10819649|NCT00048815|EG001|Reported Event|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
10819650|NCT00048815|EG002|Reported Event|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
10819651|NCT00048893|BG000|Baseline|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
10819652|NCT00048893|FG000|Participant Flow|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
10819653|NCT00048893|OG000|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
10819654|NCT00048893|EG000|Reported Event|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
10848060|NCT00287989|OG000|Outcome|150 PRE|Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
11209310|NCT02256358|OG000|Outcome|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
11209311|NCT02256358|OG001|Outcome|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
11209312|NCT02256358|EG000|Reported Event|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
11209313|NCT02256358|EG001|Reported Event|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
11209314|NCT02256384|BG000|Baseline|Respiratory Acoustic Monitoring|All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
11209315|NCT02256384|FG000|Participant Flow|Respiratory Acoustic Monitoring|All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
11209316|NCT02256384|OG000|Outcome|Respiratory Acoustic Monitoring|All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
11209317|NCT02256384|OG001|Outcome|Manual Counting|Respiratory rate was recorded by clinical evaluation every 2 hours during the first minute of the evaluation and recorded also simultaneously by RAM and by transthoracic impedance.
11209318|NCT02256384|OG002|Outcome|Transthoracic Impedance|The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.
11209319|NCT02256384|OG000|Outcome|Respiratory Acoustic Monitoring|All participants wore the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
11209320|NCT02256384|OG001|Outcome|Transthoracic Impedance|All participants wore continuous electrocardiographic monitoring capable of recording respiratory rate continuously and the alarm was set up by defaulted respiratory alarms already selected during the regular clinical practice.
11209321|NCT02256384|EG000|Reported Event|Respiratory Acoustic Monitoring|All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
11209322|NCT02256436|BG000|Baseline|Control|Participants received paclitaxel 175 mg/m^2 intravenously (IV) or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
11209323|NCT02256436|BG001|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
11209324|NCT02256436|BG002|Baseline|Total|Total of all reporting groups
11209325|NCT02256436|FG000|Participant Flow|Control|Participants received paclitaxel 175 mg/m^2 intravenously (IV) or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
11209326|NCT02256436|FG001|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
11209327|NCT02256436|OG000|Outcome|Control|Participants received paclitaxel 175 mg/m^2 intravenously (IV) or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
10819655|NCT00048932|BG000|Baseline|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819656|NCT00048932|BG001|Baseline|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
11209328|NCT02256436|OG001|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
11209329|NCT02256436|EG000|Reported Event|Control|Participants received paclitaxel 175 mg/m^2 intravenously (IV) or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
11209330|NCT02256436|EG001|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
10819657|NCT00048932|BG002|Baseline|Total|Total of all reporting groups
11209331|NCT02256436|EG002|Reported Event|Control Switched Over to Pembrolizumab|Per protocol, participants originally randomized to the Control arm that experienced disease progression were switched over to receive pembrolizumab 200 mg IV on Day 1 Q3W.
11209332|NCT02256488|BG000|Baseline|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
11209333|NCT02256488|BG001|Baseline|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
11209334|NCT02256488|BG002|Baseline|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
11209335|NCT02256488|BG003|Baseline|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
11209336|NCT02256488|BG004|Baseline|Total|Total of all reporting groups
11209337|NCT02256488|FG000|Participant Flow|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
11209338|NCT02256488|FG001|Participant Flow|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
11209339|NCT02256488|FG002|Participant Flow|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
11209340|NCT02256488|FG003|Participant Flow|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
11209341|NCT02256488|OG000|Outcome|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
11209342|NCT02256488|OG001|Outcome|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
11209343|NCT02256488|OG002|Outcome|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
11209344|NCT02256488|OG000|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
11209345|NCT02256488|OG001|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
11209346|NCT02256488|OG001|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
11209347|NCT02256488|EG000|Reported Event|TIVc Pooled|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
11209348|NCT02256488|EG001|Reported Event|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
11209349|NCT02256488|EG002|Reported Event|Total|Total number of subjects
11209350|NCT02256540|BG000|Baseline|All Participants|
11209351|NCT02256540|FG000|Participant Flow|Visit 1 Placebo - Visit 2 Estrogen - Visit 3 Resveratrol|"Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Placebo tablet: Placebo tablets designed to match active resveratrol tablets.~Visit 2 Estrogen: Climara patch was worn two days prior to and during the exercise visit.~Placebo tablet:Placebo tablets designed to match active resveratrol tablets.~Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit."
11209352|NCT02256540|FG001|Participant Flow|Visit 1 Resveratrol - Visit 2 Placebo - Visit 3 Estrogen|"Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.~Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Placebo tablet: Placebo tablets designed to match active resveratrol tablets.~Visit 3 Estrogen: Climara patch was worn two days prior to and during the exercise visit.~Placebo tablet:Placebo tablets designed to match active resveratrol tablets."
11209353|NCT02256540|FG002|Participant Flow|Visit 1 Estrogen - Visit 2 Resveratrol - Visit 3 Placebo|"Visit 1 Estrogen: Climara patch was worn two days prior to and during the exercise visit.~Placebo tablet:Placebo tablets designed to match active resveratrol tablets.~Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.~Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.~Placebo tablet: Placebo tablets designed to match active resveratrol tablets."
11209354|NCT02256540|OG000|Outcome|Placebo Patch - Placebo Tablets|"Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.~Placebo patch: Placebo patch designed to match active Climara patches.~Placebo: Placebo tablets designed to match active resveratrol tablets."
11209355|NCT02256540|OG001|Outcome|Placebo Patch - Resveratrol Tablets|"Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.~Placebo patch: Placebo patch designed to match active Climara patches.~Resveratrol"
11209356|NCT02256540|OG002|Outcome|Climara Patch - Placebo Tablets|"Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.~Climara~Placebo: Placebo tablets designed to match active resveratrol tablets."
11209357|NCT02256540|EG000|Reported Event|Placebo Patch - Placebo Tablets|"Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.~Placebo patch: Placebo patch designed to match active Climara patches.~Placebo: Placebo tablets designed to match active resveratrol tablets."
11209358|NCT02256540|EG001|Reported Event|Placebo Patch - Resveratrol Tablets|"Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.~Placebo patch: Placebo patch designed to match active Climara patches.~Resveratrol"
11209359|NCT02256540|EG002|Reported Event|Climara Patch - Placebo Tablets|"Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.~Climara~Placebo: Placebo tablets designed to match active resveratrol tablets."
11209360|NCT02256553|BG000|Baseline|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209361|NCT02256553|FG000|Participant Flow|MK-3641+MK-7243|Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209362|NCT02256553|OG000|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209363|NCT02256553|EG000|Reported Event|Period I: MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209364|NCT02256553|EG001|Reported Event|Period II: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209365|NCT02256553|EG002|Reported Event|Period III: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
11209366|NCT02256839|BG000|Baseline|Non TB Infection|"Non TB Infected Group tested with CST_001~CST_001"
11209367|NCT02256839|BG001|Baseline|Low Exposure Risk|"Low exposure Risk Group tested with CST_001~CST_001"
11209368|NCT02256839|BG002|Baseline|Total|Total of all reporting groups
11209369|NCT02256839|FG000|Participant Flow|Non TB Infection|Non TB Infected Group tested with CST001
11209370|NCT02256839|FG001|Participant Flow|Low Exposure Risk|"Low exposure Risk Group tested with CST_001~CST_001"
11209371|NCT02256839|OG000|Outcome|Non TB Infection|"Group tested with CST_001~CST_001"
11209372|NCT02256839|OG001|Outcome|Low Exposure Risk|"Group tested with CST_001~CST_001"
11209373|NCT02256839|EG000|Reported Event|Non TB Infection|Non TB Infected Group tested with CST001
11209374|NCT02256839|EG001|Reported Event|Low Exposure Risk|Low exposure Risk Group tested with CST001
11209375|NCT02256891|BG000|Baseline|Double Row Only|Double Row
10848061|NCT00287989|OG001|Outcome|1,500 PRE|Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
11209376|NCT02256891|BG001|Baseline|Double Row With PRFM|PRFM
11209377|NCT02256891|BG002|Baseline|Total|Total of all reporting groups
11209378|NCT02256891|FG000|Participant Flow|Double Row|"Double Row~Double Row"
11209379|NCT02256891|FG001|Participant Flow|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
11209380|NCT02256891|OG000|Outcome|Double Row|Double Row
11209381|NCT02256891|OG001|Outcome|Double Row With PRFM|PRFM
11209382|NCT02256891|OG000|Outcome|Double Row|"Double Row~Double Row"
11209383|NCT02256891|OG001|Outcome|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
11209384|NCT02256891|EG000|Reported Event|Double Row|"Double Row~Double Row"
11209385|NCT02256891|EG001|Reported Event|Double Row With PRFM|"Double Row with PRFM~PRFM~Double Row"
11209386|NCT02256917|BG000|Baseline|SAF/ITT Population|All patients who received at least one infusion of Human-cI rhFVIII
11209387|NCT02256917|FG000|Participant Flow|Human-cl rhFVIII|"The study consisted of 3 phases:~Pharmacokinetic (PK) Phase: 58 previously treated (≥150 exposure days) immunocompetent adults with severe hemophilia A without inhibitors patients started and completed the PK phase (PK population). Patients were treated with single dose of FVIII (60±5 IU/kg). One patient discontinued after single PK administration.~Prophylactic Treatment Phase I: 57 patients started and 56 completed Phase I; Patients were treated prophylactically every other day or 3x/week with a dose of 30-40 IU/kg BW for 1-3 months until PK data had been analysed.~Prophylactic Treatment Phase II: 56 patients started and 52 completed Phase II. Patients were treated prophylactically for 6 months using the dose and dosing interval based on individual PK data.~All 58 patients were included in the safety (SAF) and the intention-to-treat (ITT) populations."
11209388|NCT02256917|OG000|Outcome|Individualized Prophylaxis in GENA-21b|Patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis
11209389|NCT02256917|OG001|Outcome|GENA-01|All patients receiving on-demand treatment with Human-cl rhFVIII in GENA-01
11209390|NCT02256917|OG000|Outcome|Individualised Prophylaxis in GENA-21b|Patients who received at least one infusion of Human-cI rhFVIII for prophylaxis
11209391|NCT02256917|OG000|Outcome|Prophylaxis 2x/Week or Less|Patients who received at least one infusion of Human-cI rhFVIII for prophylaxis and were treated with a prophylaxis infusion frequency of 2x/week or less
11209392|NCT02256917|OG000|Outcome|Prophylaxis|Patients who received at least one infusion of Human-cI rhFVIII for prophylaxis
10848062|NCT00287989|OG002|Outcome|1,500 POST|Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
10848063|NCT00287989|EG000|Reported Event|150 PRE|Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
11209393|NCT02256917|OG000|Outcome|PK Evaluation|PK-PP population
11209394|NCT02256917|OG000|Outcome|Prophylaxis|Patients who received at least one infusion of Human-cI rhFVIII for prophylaxis in Phase III
11209395|NCT02256917|OG000|Outcome|SAF/ITT Population|All patients who received at least one infusion of Human-cI rhFVIII
11209396|NCT02256917|EG000|Reported Event|SAF/ITT Population|All patients who received at least one infusion of Human-cI rhFVIII
11209397|NCT02256969|BG000|Baseline|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209398|NCT02256969|BG001|Baseline|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209399|NCT02256969|BG002|Baseline|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
11209400|NCT02256969|BG003|Baseline|Total|Total of all reporting groups
11209401|NCT02256969|FG000|Participant Flow|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209402|NCT02256969|FG001|Participant Flow|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209403|NCT02256969|FG002|Participant Flow|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
11209404|NCT02256969|OG000|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209405|NCT02256969|OG001|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209406|NCT02256969|OG002|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
11209407|NCT02256969|EG000|Reported Event|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209408|NCT02256969|EG001|Reported Event|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
11209409|NCT02256969|EG002|Reported Event|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
11209410|NCT02256982|BG000|Baseline|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
11209411|NCT02256982|BG001|Baseline|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
11209412|NCT02256982|BG002|Baseline|Total|Total of all reporting groups
11244401|NCT02510794|OG004|Outcome|Intravitreal Injection With Ranibizumab 0.5mg|Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11209413|NCT02256982|FG000|Participant Flow|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
11209414|NCT02256982|FG001|Participant Flow|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
11209415|NCT02256982|OG000|Outcome|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
11209416|NCT02256982|OG001|Outcome|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
11209417|NCT02256982|EG000|Reported Event|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
11209418|NCT02256982|EG001|Reported Event|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
11209419|NCT02257099|BG000|Baseline|Cases|Case-only study, patients with patellar instability or mal-alignment
11209420|NCT02257099|FG000|Participant Flow|Cases|Case-only, patients with patellar instability and mal-alignment
11209421|NCT02257099|OG000|Outcome|Conventional CT|conventional CT scan
11209422|NCT02257099|OG001|Outcome|CBCT|CBCT scan
11209423|NCT02257099|OG000|Outcome|Cases|Case-only, patients with patellar instability and mal-alignment
11209424|NCT02257099|EG000|Reported Event|Cases|Case-only study, patients with patellar instability and mal-alignment
11209425|NCT02257177|BG000|Baseline|0.15 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209426|NCT02257177|BG001|Baseline|1.5 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209427|NCT02257177|BG002|Baseline|3 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209428|NCT02257177|BG003|Baseline|10 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209429|NCT02257177|BG004|Baseline|20 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209430|NCT02257177|BG005|Baseline|50 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209431|NCT02257177|BG006|Baseline|Placebo Part 1|"12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Placebo: DPI placebo"
11209432|NCT02257177|BG007|Baseline|0.3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
11209433|NCT02257177|BG008|Baseline|3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
11209434|NCT02257177|BG009|Baseline|10 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
11209435|NCT02257177|BG010|Baseline|Placebo Part 2|9 Patients with IPF are administered placebo inhaled as a dry powder.
11209436|NCT02257177|BG011|Baseline|Total|Total of all reporting groups
11209437|NCT02257177|FG000|Participant Flow|0.15 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209438|NCT02257177|FG001|Participant Flow|1.5 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209439|NCT02257177|FG002|Participant Flow|3 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209440|NCT02257177|FG003|Participant Flow|10 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209441|NCT02257177|FG004|Participant Flow|20 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209442|NCT02257177|FG005|Participant Flow|50 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209443|NCT02257177|FG006|Participant Flow|Placebo Part 1|"12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Placebo: DPI placebo"
11209444|NCT02257177|FG007|Participant Flow|0.3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
11209445|NCT02257177|FG008|Participant Flow|3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
11209446|NCT02257177|FG009|Participant Flow|10 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
11209447|NCT02257177|FG010|Participant Flow|Placebo Part 2|9 Patients with IPF are administered placebo inhaled as a dry powder.
11209448|NCT02257177|OG000|Outcome|0.15 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209449|NCT02257177|OG001|Outcome|1.5 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209450|NCT02257177|OG002|Outcome|3 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209451|NCT02257177|OG003|Outcome|10 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209452|NCT02257177|OG004|Outcome|20 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209453|NCT02257177|OG005|Outcome|50 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209454|NCT02257177|OG006|Outcome|Placebo Part 1|"12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Placebo: DPI placebo"
11209455|NCT02257177|OG007|Outcome|0.3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
11209456|NCT02257177|OG008|Outcome|3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
11209457|NCT02257177|OG009|Outcome|10 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
11209458|NCT02257177|OG010|Outcome|Placebo Part 2|9 Patients with IPF are administered placebo inhaled as a dry powder.
11209459|NCT02257177|EG000|Reported Event|0.15 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209460|NCT02257177|EG001|Reported Event|1.5 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
10819658|NCT00048932|FG000|Participant Flow|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819659|NCT00048932|FG001|Participant Flow|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819660|NCT00048932|FG002|Participant Flow|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
10819661|NCT00048932|OG000|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819662|NCT00048932|OG001|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819663|NCT00048932|OG000|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
10819664|NCT00048932|OG000|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
10819665|NCT00048932|EG000|Reported Event|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
10819666|NCT00048932|EG001|Reported Event|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects < 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10819667|NCT00048932|EG002|Reported Event|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
10822064|NCT00074282|OG000|Outcome|Arm A (PCR)|"Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.~Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.~Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.~rituximab~cyclophosphamide~pentostatin"
10822065|NCT00074282|OG000|Outcome|Arm B (Alemtuzumab: CR, nPR)|"Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients~Alemtuzumab"
10822066|NCT00074282|OG000|Outcome|Arm C (Alemtuzumab: PR, <PR, PD)|"For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.~Alemtuzumab"
10822067|NCT00074282|EG000|Reported Event|Arm A (PCR)|"Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.~Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.~Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.~rituximab cyclophosphamide pentostatin"
10822068|NCT00074282|EG001|Reported Event|Arm B (Alemtuzumab: CR, nPR)|Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients Alemtuzumab
10848064|NCT00287989|EG001|Reported Event|1,500 PRE|Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
11286219|NCT02885246|FG000|Participant Flow|Influenza Virus Positive Group|The group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017.
11209461|NCT02257177|EG002|Reported Event|3 mg TD139 (Part 1)|"4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209462|NCT02257177|EG003|Reported Event|10 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209463|NCT02257177|EG004|Reported Event|20 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209464|NCT02257177|EG005|Reported Event|50 mg TD139 Part 1|"4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Inhaled TD139: DPI Galectin-3 inhibitor"
11209465|NCT02257177|EG006|Reported Event|Placebo Part 1|"12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.~Placebo: DPI placebo"
11209466|NCT02257177|EG007|Reported Event|0.3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
11209467|NCT02257177|EG008|Reported Event|3 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
11209468|NCT02257177|EG009|Reported Event|10 mg TD139 Part 2|5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
11209469|NCT02257177|EG010|Reported Event|Placebo Part 2|9 Patients with IPF are administered placebo inhaled as a dry powder.
11209470|NCT02257372|BG000|Baseline|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11209471|NCT02257372|BG001|Baseline|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
11209472|NCT02257372|BG002|Baseline|Total|Total of all reporting groups
11209473|NCT02257372|FG000|Participant Flow|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11209474|NCT02257372|FG001|Participant Flow|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
11209475|NCT02257372|OG000|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
11209476|NCT02257372|OG001|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
11209477|NCT02257372|EG000|Reported Event|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed
11209478|NCT02257372|EG001|Reported Event|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
11209479|NCT02257385|BG000|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
10819668|NCT00048997|BG000|Baseline|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
10819669|NCT00048997|BG001|Baseline|Observation|Observation.
10819670|NCT00048997|BG002|Baseline|Total|Total of all reporting groups
10819671|NCT00048997|FG000|Participant Flow|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
10819672|NCT00048997|FG001|Participant Flow|Observation|Observation
10819673|NCT00048997|OG000|Outcome|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
10819674|NCT00048997|OG001|Outcome|Observation|Observation
10848065|NCT00287989|EG002|Reported Event|1,500 POST|Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
11209480|NCT02257385|BG001|Baseline|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209481|NCT02257385|BG002|Baseline|Total|Total of all reporting groups
11209482|NCT02257385|FG000|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209483|NCT02257385|FG001|Participant Flow|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209484|NCT02257385|OG000|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209485|NCT02257385|OG001|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209486|NCT02257385|EG000|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209487|NCT02257385|EG001|Reported Event|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
11209488|NCT02257489|BG000|Baseline|50 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209489|NCT02257489|BG001|Baseline|100 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209490|NCT02257489|BG002|Baseline|200 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209491|NCT02257489|BG003|Baseline|100 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209492|NCT02257489|BG004|Baseline|200 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209493|NCT02257489|BG005|Baseline|100 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209494|NCT02257489|BG006|Baseline|150 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209495|NCT02257489|BG007|Baseline|Pooled Placebo (RF)|Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort)
11209496|NCT02257489|BG008|Baseline|Pooled Placebo (TA)|Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
11209497|NCT02257489|BG009|Baseline|Total|Total of all reporting groups
11209498|NCT02257489|FG000|Participant Flow|50 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209499|NCT02257489|FG001|Participant Flow|100 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209500|NCT02257489|FG002|Participant Flow|200 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209501|NCT02257489|FG003|Participant Flow|100 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209502|NCT02257489|FG004|Participant Flow|200 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209503|NCT02257489|FG005|Participant Flow|100 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209504|NCT02257489|FG006|Participant Flow|150 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209505|NCT02257489|FG007|Participant Flow|Pooled Placebo (RF)|Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort)
11209506|NCT02257489|FG008|Participant Flow|Pooled Placebo (TA)|Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
11209507|NCT02257489|OG000|Outcome|50 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209508|NCT02257489|OG001|Outcome|100 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209509|NCT02257489|OG002|Outcome|200 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209510|NCT02257489|OG003|Outcome|100 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209511|NCT02257489|OG004|Outcome|200 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209512|NCT02257489|OG005|Outcome|100 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209513|NCT02257489|OG006|Outcome|150 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209514|NCT02257489|OG007|Outcome|Pooled Placebo (RF)|Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort)
11209515|NCT02257489|OG008|Outcome|Pooled Placebo (TA)|Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
11209516|NCT02257489|EG000|Reported Event|50 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209517|NCT02257489|EG001|Reported Event|100 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209518|NCT02257489|EG002|Reported Event|200 mg Single Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209519|NCT02257489|EG003|Reported Event|100 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209520|NCT02257489|EG004|Reported Event|200 mg Multiple Dose (RF)|"8 subjects in total; 6 subjects to receive ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the rectus femoris (RF)~ACE-083: recombinant fusion protein"
11209521|NCT02257489|EG005|Reported Event|100 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209522|NCT02257489|EG006|Reported Event|150 mg Multiple Dose (TA)|"9 subjects in total; 6 subjects to receive ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly in the tibialis anterior (TA)~ACE-083: recombinant fusion protein"
11209523|NCT02257489|EG007|Reported Event|Pooled Placebo (RF)|Pooled placebo from the rectus femoris (RF) cohorts, n=10 (n=2 from each RF cohort)
11209524|NCT02257489|EG008|Reported Event|Pooled Placebo (TA)|Pooled placebo from the tibialis anterior cohorts, n=6 (n=3 from each TA cohort)
11209525|NCT02257541|BG000|Baseline|Phase 1b, Dose Level -1|Phase 1b, Dose Level -1: BGJ398 50 mg
11209526|NCT02257541|BG001|Baseline|Phase 1b, Dose Level 1|Phase 1b, Dose Level 1: BGJ398 75 mg
11209527|NCT02257541|BG002|Baseline|Phase 1b, Dose Level 2|Phase 1b, Dose Level 2: BGJ398 100 mg
11209528|NCT02257541|BG003|Baseline|Phase 1b, Dose Level -2|Phase 1b, Dose Level -2: BGJ398 25 mg
11209529|NCT02257541|BG004|Baseline|Phase II|Phase II: BGJ398 75mg
11209530|NCT02257541|BG005|Baseline|Total|Total of all reporting groups
11209531|NCT02257541|FG000|Participant Flow|Phase 1b, Dose Level -1|Phase 1b, Dose Level -1: BGJ398 50 mg
11209532|NCT02257541|FG001|Participant Flow|Phase 1b, Dose Level 1|Phase 1b, Dose Level 1: BGJ398 75 mg
11209533|NCT02257541|FG002|Participant Flow|Phase 1b, Dose Level 2|Phase 1b, Dose Level 2: BGJ398 100 mg
11209534|NCT02257541|FG003|Participant Flow|Phase 1b, Dose Level -2|Phase 1b, Dose Level -2: BGJ398 25 mg
11209535|NCT02257541|FG004|Participant Flow|Phase II|Phase II: BGJ398 75mg
11209536|NCT02257541|OG000|Outcome|Phase 1b, Dose Level -1|Phase 1b, Dose Level -1: BGJ398 50 mg
11209537|NCT02257541|OG001|Outcome|Phase 1b, Dose Level 1|Phase 1b, Dose Level 1: BGJ398 75 mg
11209538|NCT02257541|OG002|Outcome|Phase 1b, Dose Level 2|Phase 1b, Dose Level 2: BGJ398 100 mg
11209539|NCT02257541|OG003|Outcome|Phase 1b, Dose Level -2|Phase 1b, Dose Level -2: BGJ398 25 mg
11209540|NCT02257541|EG000|Reported Event|Phase 1b, Dose Level -1|Phase 1b, Dose Level -1: BGJ398 50 mg
11209541|NCT02257541|EG001|Reported Event|Phase 1b, Dose Level 1|Phase 1b, Dose Level 1: BGJ398 75 mg
11209542|NCT02257541|EG002|Reported Event|Phase 1b, Dose Level 2:|Phase 1b, Dose Level 2: BGJ398 100 mg
11209543|NCT02257541|EG003|Reported Event|Phase 1b, Dose Level -2|Phase 1b, Dose Level -2: BGJ398 25 mg
11209544|NCT02257541|EG004|Reported Event|Phase II|Phase II: BGJ398 75mg
11209545|NCT02257632|BG000|Baseline|Ranibizumab|6 monthly intravitreal injections of 0.5 mg ranibizumab
11209546|NCT02257632|BG001|Baseline|Aflibercept and Ranibizumab|3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
11209547|NCT02257632|BG002|Baseline|Total|Total of all reporting groups
11209548|NCT02257632|FG000|Participant Flow|Ranibizumab|6 monthly intravitreal injections of 0.5 mg ranibizumab
11209549|NCT02257632|FG001|Participant Flow|Aflibercept and Ranibizumab|3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
11209550|NCT02257632|OG000|Outcome|Ranibizumab|6 monthly intravitreal injections of 0.5 mg ranibizumab
11209551|NCT02257632|OG001|Outcome|Aflibercept and Ranibizumab|3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
11209552|NCT02257632|EG000|Reported Event|Ranibizumab (Up to Month 3)|3 monthly intravitreal injections of 0.5 mg ranibizumab
11209553|NCT02257632|EG001|Reported Event|Ranibizumab (After Month 3)|3 monthly intravitreal injections of 0.5 mg ranibizumab
11209554|NCT02257632|EG002|Reported Event|Aflibercept and Ranibizumab (Up to Month 3 - Aflibercept)|3 monthly intravitreal injections of 2 mg aflibercept (AEs reported that started before switching to ranibizumab)
11209555|NCT02257632|EG003|Reported Event|Aflibercept and Ranibizumab (After Month 3 - Ranibizumab)|3 monthly intravitreal injections of 0.5 mg ranibizumab (AEs reported that started on or after switching to ranibizumab)
11215471|NCT02299388|OG001|Outcome|Placebo|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215472|NCT02299388|EG000|Reported Event|Liraglutide|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215473|NCT02299388|EG001|Reported Event|Placebo|"All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.~Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval."
11215474|NCT02299427|BG000|Baseline|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
11215475|NCT02299427|BG001|Baseline|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
11215476|NCT02299427|BG002|Baseline|Total|Total of all reporting groups
11215477|NCT02299427|FG000|Participant Flow|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
11215478|NCT02299427|FG001|Participant Flow|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
11215479|NCT02299427|OG000|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
11215480|NCT02299427|OG001|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
11215481|NCT02299427|EG000|Reported Event|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks~There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis."
11215482|NCT02299427|EG001|Reported Event|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
11286220|NCT02885246|OG000|Outcome|Influenza Virus Positive Group|The group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017.
10819675|NCT00048997|EG000|Reported Event|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy..
10848066|NCT00288015|BG000|Baseline|Bevacizumab|"Bevacizumab treatment until disease progression or intolerance~Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle)."
11209556|NCT02257684|BG000|Baseline|Pegcrisantaspase|pegcrisantaspase
11209557|NCT02257684|FG000|Participant Flow|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
11209558|NCT02257684|OG000|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
11209559|NCT02257684|EG000|Reported Event|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
11209560|NCT02257957|BG000|Baseline|Platelet -Rich Plasma (PRP)|"15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90~PRP injection"
11209561|NCT02257957|BG001|Baseline|Standard Care|"15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90~Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90"
11209562|NCT02257957|BG002|Baseline|Total|Total of all reporting groups
11209563|NCT02257957|FG000|Participant Flow|Platelet -Rich Plasma (PRP)|"15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90~PRP injection"
11209564|NCT02257957|FG001|Participant Flow|Standard Care|"15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90~Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90"
11209565|NCT02257957|OG000|Outcome|Platelet -Rich Plasma (PRP)|"15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90~PRP injection"
11209566|NCT02257957|OG001|Outcome|Standard Care|"15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90~Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90"
11209567|NCT02257957|EG000|Reported Event|Platelet -Rich Plasma (PRP)|"15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90~PRP injection"
11209568|NCT02257957|EG001|Reported Event|Standard Care|"15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90~Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90"
11209569|NCT02257970|BG000|Baseline|Part 1: Exploratory Group|"Ketoprofen 225-300 mgs daily, taken orally~Ketoprofen-exploratory group: 225-300 mgs daily for four to six months"
11209570|NCT02257970|BG001|Baseline|Part 2: Open-label Group|"Ketoprofen 225 mg daily~Open-label group: 75 mgs, 1 capsule, taken orally, three times daily, for four months"
11209571|NCT02257970|BG002|Baseline|Part 3: Placebo Group|"Participants randomized to receive placebo:~1 capsule, taken orally, three times daily, for four months"
11209572|NCT02257970|BG003|Baseline|Part 3: Ketoprofen Group|"Participants randomized to receive active medication, Ketoprofen 225 mg daily:~Ketoprofen: 75 mgs, 1 capsule, three times daily, for four months"
11209573|NCT02257970|BG004|Baseline|Total|Total of all reporting groups
11209574|NCT02257970|FG000|Participant Flow|Part 1: Exploratory Group|"Ketoprofen 225-300 mgs daily, taken orally~Ketoprofen-exploratory group: 225-300 mgs daily for four to six months"
11209575|NCT02257970|FG001|Participant Flow|Part 2: Open-label Group|"Ketoprofen 225 mg daily, taken orally~Open-label group: 75 mgs, three times daily, for four months"
11209576|NCT02257970|FG002|Participant Flow|Part 3: Placebo Group|"Participants randomized to receive placebo: placebo, three times daily, taken orally~Placebo: 1 capsule, three times daily, for four months"
11209577|NCT02257970|FG003|Participant Flow|Part 3: Ketoprofen Group|"Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally~Ketoprofen: 1 capsule, three times daily, for four months"
11209578|NCT02257970|OG000|Outcome|Part 1: Exploratory Group|"Ketoprofen 225-300 mgs daily, taken orally~Ketoprofen-exploratory group: 225-300 mgs daily for four to six months"
11209579|NCT02257970|OG000|Outcome|Part 2: Open-label Group|"Ketoprofen 225 mg daily, taken orally~Open-label group: 75 mgs, three times daily, for four months"
11209580|NCT02257970|OG001|Outcome|Part 2: Unaffected Tissue Samples|Results from normal samples from Part 2 participants are presented in this reporting group.
11209581|NCT02257970|OG000|Outcome|Part 3: Placebo Group|Participants randomized to receive placebo: placebo, three times daily, taken orally Placebo: 1 capsule, three times daily, for four months
11209582|NCT02257970|OG001|Outcome|Part 3: Ketoprofen Group|Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally Ketoprofen: 1 capsule, three times daily, for four months
11209583|NCT02257970|OG000|Outcome|Part 3 Placebo|Placebo, 1 capsule taken orally, three times daily, for four months
11209584|NCT02257970|OG001|Outcome|Part 3: Ketoprofen Group|Ketoprofen, 75 mgs, 1 capsule taken orally, three times daily, for four months
11209585|NCT02257970|OG002|Outcome|Part 3: Unaffected Tissue Samples|Results from normal samples from Part 3 participants are presented in this reporting group.
11209586|NCT02257970|OG001|Outcome|Part 3: Placebo Group|"Participants randomized to receive placebo:~1 capsule, three times daily, for four months"
11209587|NCT02257970|OG002|Outcome|Part 3: Ketoprofen Group|"Participants randomized to receive active medication:~Ketoprofen 75 mgs., 1 capsule, taken orally, three times daily, for four months"
11209588|NCT02257970|OG000|Outcome|Part 2: Open-label Group|"Ketoprofen 225 mg daily~Open-label group: 75 mgs, 1 capsule, taken orally, three times daily, for four months"
11209589|NCT02257970|OG001|Outcome|Part 3: Placebo Group|"Participants randomized to receive placebo:~1 capsule, taken orally, three times daily, for four months"
11209590|NCT02257970|OG000|Outcome|Part 3: Placebo|Placebo, 1 capsule taken orally, three times daily, for four months
11209591|NCT02257970|EG000|Reported Event|Part 1: Exploratory Group|"Ketoprofen 225-300 mgs daily, taken orally~Ketoprofen-exploratory group: 225-300 mgs daily for four to six months"
11209592|NCT02257970|EG001|Reported Event|Part 2: Open-label Group|"Ketoprofen 225 mg daily, taken orally~Open-label group: 75 mgs, three times daily, for four months"
11209593|NCT02257970|EG002|Reported Event|Part 3: Placebo Group|"Participants randomized to receive placebo: placebo, three times daily, taken orally~Placebo: 1 capsule, three times daily, for four months"
11209594|NCT02257970|EG003|Reported Event|Part 3: Ketoprofen Group|"Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally~Ketoprofen: 1 capsule, three times daily, for four months"
11209595|NCT02258074|BG000|Baseline|Lanthanum Carbonate + Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Lanthanum Carbonate"
11209596|NCT02258074|BG001|Baseline|Lanthanum Carbonate + Nicotinamide Placebo|"Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.~Lanthanum Carbonate~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule"
11209597|NCT02258074|BG002|Baseline|Lanthanum Carbonate Placebo and Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209598|NCT02258074|BG003|Baseline|Lanthanum Carbonate Placebo and Nicotinamide Placebo|"One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209599|NCT02258074|BG004|Baseline|Total|Total of all reporting groups
11209600|NCT02258074|FG000|Participant Flow|Lanthanum Carbonate + Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Lanthanum Carbonate"
11209601|NCT02258074|FG001|Participant Flow|Lanthanum Carbonate + Nicotinamide Placebo|"Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.~Lanthanum Carbonate~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule"
11209602|NCT02258074|FG002|Participant Flow|Lanthanum Carbonate Placebo and Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209603|NCT02258074|FG003|Participant Flow|Lanthanum Carbonate Placebo and Nicotinamide Placebo|"One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209604|NCT02258074|OG000|Outcome|Lanthanum Carbonate + Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Lanthanum Carbonate"
11209605|NCT02258074|OG001|Outcome|Lanthanum Carbonate + Nicotinamide Placebo|"Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.~Lanthanum Carbonate~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule"
11209606|NCT02258074|OG002|Outcome|Lanthanum Carbonate Placebo and Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209607|NCT02258074|OG003|Outcome|Lanthanum Carbonate Placebo and Nicotinamide Placebo|"One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209608|NCT02258074|EG000|Reported Event|Lanthanum Carbonate + Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Lanthanum Carbonate"
11209609|NCT02258074|EG001|Reported Event|Lanthanum Carbonate + Nicotinamide Placebo|"Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months.~Lanthanum Carbonate~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule"
11209610|NCT02258074|EG002|Reported Event|Lanthanum Carbonate Placebo and Nicotinamide|"One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Nicotinamide~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209611|NCT02258074|EG003|Reported Event|Lanthanum Carbonate Placebo and Nicotinamide Placebo|"One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months.~Placebo (for Nicotinamide): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule~Placebo (for lanthanum carbonate): Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule"
11209612|NCT02258139|BG000|Baseline|Study Group 1|"1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens~B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens."
11209613|NCT02258139|FG000|Participant Flow|Study Group 1|"1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens~B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens."
11209614|NCT02258139|OG000|Outcome|Study Group 1|"1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens~B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens."
11209615|NCT02258139|OG000|Outcome|Test Eye With Lens|Test eye after lens removed
11209616|NCT02258139|OG001|Outcome|Control Eye|Control eye in subjects with lens in test eye
11209617|NCT02258139|EG000|Reported Event|Study Group 1|"1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens~B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens."
11209618|NCT02258152|BG000|Baseline|Placebo|Placebo: Placebo QD
11209619|NCT02258152|BG001|Baseline|SYN120|SYN120: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
11209620|NCT02258152|BG002|Baseline|Total|Total of all reporting groups
11209621|NCT02258152|FG000|Participant Flow|Placebo|Placebo: Placebo QD
11209622|NCT02258152|FG001|Participant Flow|SYN120|SYN120: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
11209623|NCT02258152|OG000|Outcome|Placebo|Placebo: Placebo QD
11209624|NCT02258152|OG001|Outcome|SYN120|SYN120: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
11209625|NCT02258152|EG000|Reported Event|Placebo|Placebo: Placebo QD
11209626|NCT02258152|EG001|Reported Event|SYN120|SYN120: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
11209627|NCT02258217|BG000|Baseline|Single Arm|"Acthar 80 units subcutaneously for five consecutive days.~Acthar: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults."
11209628|NCT02258217|FG000|Participant Flow|Single Arm|"Acthar 80 units subcutaneously for five consecutive days.~Acthar: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults."
11209629|NCT02258217|OG000|Outcome|Single Arm|"Acthar 80 units subcutaneously for five consecutive days.~Acthar: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults."
11209630|NCT02258217|EG000|Reported Event|Single Arm|"Acthar 80 units subcutaneously for five consecutive days.~Acthar: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults."
11209631|NCT02258256|BG000|Baseline|Preeclamptic Women|"All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11209632|NCT02258256|FG000|Participant Flow|Preeclamptic Women|"All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11209633|NCT02258256|OG000|Outcome|Preeclamptic Women|"All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11209634|NCT02258256|EG000|Reported Event|Preeclamptic Women|"All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11209635|NCT02258334|BG000|Baseline|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209636|NCT02258334|BG001|Baseline|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
11209637|NCT02258334|BG002|Baseline|Group 3|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209638|NCT02258334|BG003|Baseline|Group 4|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
11209639|NCT02258334|BG004|Baseline|Total|Total of all reporting groups
11209640|NCT02258334|FG000|Participant Flow|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209641|NCT02258334|FG001|Participant Flow|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
11209642|NCT02258334|FG002|Participant Flow|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209643|NCT02258334|FG003|Participant Flow|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
11209644|NCT02258334|OG000|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209645|NCT02258334|OG001|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
11209646|NCT02258334|OG002|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209647|NCT02258334|OG003|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
11209648|NCT02258334|OG001|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
11209649|NCT02258334|OG003|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
11209650|NCT02258334|EG000|Reported Event|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209651|NCT02258334|EG001|Reported Event|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
11209652|NCT02258334|EG002|Reported Event|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
11209653|NCT02258334|EG003|Reported Event|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
11209654|NCT02258373|BG000|Baseline|CGM Only|"Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.~In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.~CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm"
11209655|NCT02258373|BG001|Baseline|CGM+BGM|"Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.~CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter"
11209656|NCT02258373|BG002|Baseline|Total|Total of all reporting groups
11209657|NCT02258373|FG000|Participant Flow|CGM Only|"Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.~In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.~CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm"
11209658|NCT02258373|FG001|Participant Flow|CGM+BGM|"Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.~CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter"
11209659|NCT02258373|OG000|Outcome|CGM Only|"Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.~In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.~CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm"
11209660|NCT02258373|OG001|Outcome|CGM+BGM|"Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.~CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter"
11209661|NCT02258373|EG000|Reported Event|CGM Only|"Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.~In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.~CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm"
11209662|NCT02258373|EG001|Reported Event|CGM+BGM|"Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.~CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter"
10848067|NCT00288015|FG000|Participant Flow|Bevacizumab|"Bevacizumab treatment until disease progression or intolerance~Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle)."
11209663|NCT02258412|BG000|Baseline|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
11209664|NCT02258412|BG001|Baseline|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
11209665|NCT02258412|BG002|Baseline|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
11209666|NCT02258412|BG003|Baseline|Total|Total of all reporting groups
11209667|NCT02258412|FG000|Participant Flow|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
11209668|NCT02258412|FG001|Participant Flow|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
11209669|NCT02258412|FG002|Participant Flow|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
11209670|NCT02258412|OG000|Outcome|Alcohol Hand Sanitizer Foam|"Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.~Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day"
11209671|NCT02258412|OG001|Outcome|Hand Antiseptic With CHG and Alcohol|"Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.~hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers."
11209672|NCT02258412|EG000|Reported Event|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
11209673|NCT02258412|EG001|Reported Event|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
11209674|NCT02258412|EG002|Reported Event|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
11209675|NCT02258464|BG000|Baseline|Radium 223 Dichloride|Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209676|NCT02258464|BG001|Baseline|Placebo|Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209677|NCT02258464|BG002|Baseline|Total|Total of all reporting groups
11209678|NCT02258464|FG000|Participant Flow|Radium 223 Dichloride|Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209679|NCT02258464|FG001|Participant Flow|Placebo|Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209680|NCT02258464|OG000|Outcome|Radium 223 Dichloride|Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209681|NCT02258464|OG001|Outcome|Placebo|Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209682|NCT02258464|EG000|Reported Event|Radium 223 Dichloride|Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209683|NCT02258464|EG001|Reported Event|Placebo|Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
11209684|NCT02258477|BG000|Baseline|All Study Subjects|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week."
11209685|NCT02258477|FG000|Participant Flow|Sequence 1 (D-B-A-C)|Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.
11209686|NCT02258477|FG001|Participant Flow|Sequence 2 (A-D-C-B)|Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.
11209687|NCT02258477|FG002|Participant Flow|Sequence 3 (C-A-B-D)|Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.
11209688|NCT02258477|FG003|Participant Flow|Sequence 4 (B-C-D-A)|Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
11209689|NCT02258477|OG000|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
11209690|NCT02258477|OG001|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
11209691|NCT02258477|OG002|Outcome|50 Calorie Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
11209692|NCT02258477|OG003|Outcome|10 Calorie|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
11209693|NCT02258477|OG002|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
11209694|NCT02258477|OG003|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
11209695|NCT02258477|EG000|Reported Event|All Study Subjects|Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
11209696|NCT02258529|BG000|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
11209697|NCT02258529|FG000|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
11209698|NCT02258529|OG000|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
11209699|NCT02258529|EG000|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
11209700|NCT02259010|BG000|Baseline|Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg|All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).
11209701|NCT02259010|FG000|Participant Flow|Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg|All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).
11209702|NCT02259010|OG000|Outcome|Alisertib Without Itraconazole|Alisertib 30 mg, tablets, orally, on Day 1 in Part A.
11209703|NCT02259010|OG001|Outcome|Alisertib With Itraconazole|Itraconazole, 200 mg, oral solution, once daily on Days 5 to 13 along with alisertib 30 mg, tablets, orally, on Day 10 in Part A .
11209704|NCT02259010|OG000|Outcome|Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg|All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).
11209705|NCT02259010|EG000|Reported Event|Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg|All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).
11209706|NCT02259088|BG000|Baseline|Ranibizumab (RFB002)|3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
11209707|NCT02259088|BG001|Baseline|Laser|Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
11209708|NCT02259088|BG002|Baseline|Total|Total of all reporting groups
11209709|NCT02259088|FG000|Participant Flow|Ranibizumab (RFB002)|3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
11209710|NCT02259088|FG001|Participant Flow|Laser|Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
10969586|NCT00906698|FG002|Participant Flow|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
11209711|NCT02259088|OG000|Outcome|Ranibizumab (RFB002)|3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
11209712|NCT02259088|OG001|Outcome|Laser|Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
11209713|NCT02259088|EG000|Reported Event|Ranibizumab (RFB002)|3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
11209714|NCT02259088|EG001|Reported Event|Laser|Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
11209715|NCT02259114|BG000|Baseline|MK-8628 Continuous Dosing Regimen 80 mg/Day|Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209716|NCT02259114|BG001|Baseline|MK-8628 Continuous Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209717|NCT02259114|BG002|Baseline|MK-8628 Days 1-7 Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209718|NCT02259114|BG003|Baseline|MK-8628 Days 1-7 Dosing Regimen 120 mg/Day|Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209719|NCT02259114|BG004|Baseline|MK-8628 Days 1-7 Dosing Regimen 160 mg/Day|Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209720|NCT02259114|BG005|Baseline|Total|Total of all reporting groups
11209721|NCT02259114|FG000|Participant Flow|MK-8628 Continuous Dosing Regimen 80 mg/Day|Participants received MK-8628 (formerly OTX015) capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209722|NCT02259114|FG001|Participant Flow|MK-8628 Continuous Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209723|NCT02259114|FG002|Participant Flow|MK-8628 Days 1-7 Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209724|NCT02259114|FG003|Participant Flow|MK-8628 Days 1-7 Dosing Regimen 120 mg/Day|Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209725|NCT02259114|FG004|Participant Flow|MK-8628 Days 1-7 Dosing Regimen 160 mg/Day|Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209726|NCT02259114|OG000|Outcome|MK-8628 Continuous Dosing Regimen 80 mg/Day|Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209727|NCT02259114|OG001|Outcome|MK-8628 Continuous Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209728|NCT02259114|OG002|Outcome|MK-8628 Days 1-7 Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209729|NCT02259114|OG003|Outcome|MK-8628 Days 1-7 Dosing Regimen 120 mg/Day|Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209730|NCT02259114|OG004|Outcome|MK-8628 Days 1-7 Dosing Regimen 160 mg/Day|Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209731|NCT02259114|EG000|Reported Event|MK-8628 Continuous Dosing Regimen 80 mg/Day|Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209732|NCT02259114|EG001|Reported Event|MK-8628 Continuous Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
11209733|NCT02259114|EG002|Reported Event|MK-8628 Days 1-7 Dosing Regimen 100 mg/Day|Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209734|NCT02259114|EG003|Reported Event|MK-8628 Days 1-7 Dosing Regimen 120 mg/Day|Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209735|NCT02259114|EG004|Reported Event|MK-8628 Days 1-7 Dosing Regimen 160 mg/Day|Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
11209736|NCT02259231|BG000|Baseline|Omaveloxolone 5 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg"
11209737|NCT02259231|BG001|Baseline|Omaveloxolone 10 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209738|NCT02259231|BG002|Baseline|Omaveloxolone 5 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg"
11209739|NCT02259231|BG003|Baseline|Omaveloxolone 10 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209740|NCT02259231|BG004|Baseline|Omaveloxolone 20 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209741|NCT02259231|BG005|Baseline|Omaveloxolone 100 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209742|NCT02259231|BG006|Baseline|Omaveloxolone 150 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209743|NCT02259231|BG007|Baseline|Total|Total of all reporting groups
11209744|NCT02259231|FG000|Participant Flow|Omaveloxolone 5 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg"
11209745|NCT02259231|FG001|Participant Flow|Omaveloxolone 10 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209746|NCT02259231|FG002|Participant Flow|Omaveloxolone 5 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg"
11209747|NCT02259231|FG003|Participant Flow|Omaveloxolone 10 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209748|NCT02259231|FG004|Participant Flow|Omaveloxolone 20 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209749|NCT02259231|FG005|Participant Flow|Omaveloxolone 100 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11286221|NCT02885246|EG000|Reported Event|Influenza Virus Positive Group|The group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017.
11209750|NCT02259231|FG006|Participant Flow|Omaveloxolone 150 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209751|NCT02259231|OG000|Outcome|Omaveloxolone 5 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg"
11209752|NCT02259231|OG001|Outcome|Omaveloxolone 10 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209753|NCT02259231|OG002|Outcome|Omaveloxolone 5 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg"
11209754|NCT02259231|OG003|Outcome|Omaveloxolone 10 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209755|NCT02259231|OG004|Outcome|Omaveloxolone 20 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209756|NCT02259231|OG005|Outcome|Omaveloxolone 100 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209757|NCT02259231|OG006|Outcome|Omaveloxolone 150 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209758|NCT02259231|EG000|Reported Event|Omaveloxolone 5 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg"
11209759|NCT02259231|EG001|Reported Event|Omaveloxolone 10 mg & Ipilimumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.~Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209760|NCT02259231|EG002|Reported Event|Omaveloxolone 5 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg"
11209761|NCT02259231|EG003|Reported Event|Omaveloxolone 10 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209762|NCT02259231|EG004|Reported Event|Omaveloxolone 20 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209763|NCT02259231|EG005|Reported Event|Omaveloxolone 100 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11286222|NCT02885350|BG000|Baseline|Spinal Fentanyl|"20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
10819676|NCT00049036|BG000|Baseline|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
11209764|NCT02259231|EG006|Reported Event|Omaveloxolone 150 mg & Nivolumab|"Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.~Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg~Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label"
11209765|NCT02259348|BG000|Baseline|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
11209766|NCT02259348|FG000|Participant Flow|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
11209767|NCT02259348|OG000|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
11209768|NCT02259348|EG000|Reported Event|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
11209769|NCT02259400|BG000|Baseline|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
11209770|NCT02259400|BG001|Baseline|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
11209771|NCT02259400|BG002|Baseline|Total|Total of all reporting groups
11209772|NCT02259400|FG000|Participant Flow|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
11286223|NCT02885350|BG001|Baseline|Epidural Fentanyl|"100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
10819677|NCT00049036|BG001|Baseline|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
11209773|NCT02259400|FG001|Participant Flow|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
11209774|NCT02259400|OG000|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
11209775|NCT02259400|OG001|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
11209776|NCT02259400|EG000|Reported Event|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
11209777|NCT02259400|EG001|Reported Event|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
11209778|NCT02259582|BG000|Baseline|Placebo/Placebo Arm (Arm 1)|Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209779|NCT02259582|BG001|Baseline|Demcizumab/Placebo Arm (Arm 2)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209780|NCT02259582|BG002|Baseline|Demcizumab/Demcizumab Arm (Arm 3)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
11209781|NCT02259582|BG003|Baseline|Total|Total of all reporting groups
11209782|NCT02259582|FG000|Participant Flow|Placebo/Placebo Arm (Arm 1)|Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209783|NCT02259582|FG001|Participant Flow|Demcizumab/Placebo Arm (Arm 2)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209784|NCT02259582|FG002|Participant Flow|Demcizumab/Demcizumab Arm (Arm 3)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
11209785|NCT02259582|OG000|Outcome|Placebo/Placebo Arm (Arm 1)|Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209786|NCT02259582|OG001|Outcome|Demcizumab/Placebo Arm (Arm 2)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209787|NCT02259582|OG002|Outcome|Demcizumab/Demcizumab Arm (Arm 3)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
11209788|NCT02259582|EG000|Reported Event|Placebo/Placebo Arm (Arm 1)|Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209789|NCT02259582|EG001|Reported Event|Demcizumab/Placebo Arm (Arm 2)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
11209790|NCT02259582|EG002|Reported Event|Demcizumab/Demcizumab Arm (Arm 3)|Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
10819678|NCT00049036|BG002|Baseline|Total|Total of all reporting groups
10819679|NCT00049036|FG000|Participant Flow|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
10819680|NCT00049036|FG001|Participant Flow|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
10819681|NCT00049036|OG000|Outcome|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
10819682|NCT00049036|OG001|Outcome|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
10819683|NCT00049036|EG000|Reported Event|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
10819684|NCT00049036|EG001|Reported Event|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
10819685|NCT00049127|BG000|Baseline|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
10819686|NCT00049127|BG001|Baseline|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
10819687|NCT00049127|BG002|Baseline|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
10819688|NCT00049127|BG003|Baseline|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
10819689|NCT00049127|BG004|Baseline|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
10819690|NCT00049127|BG005|Baseline|Total|Total of all reporting groups
10819691|NCT00049127|FG000|Participant Flow|Study 1 Arm C|"Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses."
11209791|NCT02259608|BG000|Baseline|yBCG|15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
11209792|NCT02259608|FG000|Participant Flow|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
11209793|NCT02259608|OG000|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
11209794|NCT02259608|EG000|Reported Event|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
11209795|NCT02259699|BG000|Baseline|Decision Aid (PCOA)|Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
11209796|NCT02259699|BG001|Baseline|UC (Standard Care)|Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
11209797|NCT02259699|BG002|Baseline|Total|Total of all reporting groups
11209798|NCT02259699|FG000|Participant Flow|Decision Aid (PCOA)|Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
11209799|NCT02259699|FG001|Participant Flow|UC (Standard Care)|Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
10819692|NCT00049127|FG001|Participant Flow|Study 2 Arm A|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
10819693|NCT00049127|FG002|Participant Flow|Study 2 Arm B|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at 300 mg b.i.d."
10819694|NCT00049127|FG003|Participant Flow|Study 3 Arm D|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
10819695|NCT00049127|FG004|Participant Flow|Study 3 Arm E|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at 300 mg b.i.d."
10819696|NCT00049127|OG000|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
10819697|NCT00049127|OG001|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
10819698|NCT00049127|OG002|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
10819699|NCT00049127|OG003|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
10819700|NCT00049127|OG004|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
10819701|NCT00049127|EG000|Reported Event|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
10819702|NCT00049127|EG001|Reported Event|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
10819703|NCT00049127|EG002|Reported Event|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
10819704|NCT00049127|EG003|Reported Event|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
10819705|NCT00049127|EG004|Reported Event|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
10848068|NCT00288015|OG000|Outcome|Bevacizumab|"Bevacizumab treatment until disease progression or intolerance~Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle)."
11209800|NCT02259699|OG000|Outcome|Decision Aid (PCOA)|Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
11209801|NCT02259699|OG001|Outcome|UC (Standard Care)|Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
11209802|NCT02259699|EG000|Reported Event|Decision Aid (PCOA)|Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
11209803|NCT02259699|EG001|Reported Event|UC (Standard Care)|Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
11209804|NCT02260154|BG000|Baseline|Post-cholecystectomy Gastrointestinal Spasms|"Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day~Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed"
11209805|NCT02260154|FG000|Participant Flow|Post-cholecystectomy Gastrointestinal Spasms|"Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day~Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed"
11209806|NCT02260154|OG000|Outcome|Post-cholecystectomy Gastrointestinal Spasms|"Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day~Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed"
11209807|NCT02260154|OG000|Outcome|Post-cholecystectomy Gastrointestinal Spasms|"Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day~Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed"
11209808|NCT02260154|EG000|Reported Event|Post-cholecystectomy Gastrointestinal Spasms|"Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day~Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed"
11209809|NCT02260180|BG000|Baseline|A-101 40%|A-101 40% Topical Solution
11209810|NCT02260180|BG001|Baseline|A-101 32.5%|A-101 32.5% Topical Solution
11209811|NCT02260180|BG002|Baseline|A-101 Vehicle Topical Solution|A-101 0% Topical Solution (vehicle)
11209812|NCT02260180|BG003|Baseline|Total|Total of all reporting groups
11209813|NCT02260180|FG000|Participant Flow|A-101 40% Topical Solution|"A-101 40% Topical Solution~A-101: Topical Solution"
11209814|NCT02260180|FG001|Participant Flow|A-101 32.5% Topical Solution|"A-101 32.5% Topical Solution~A-101: Topical Solution"
11209815|NCT02260180|FG002|Participant Flow|A-101 Vehicle Topical Solution|"A-101 0% Topical Solution (vehicle)~A-101: Topical Solution"
11209816|NCT02260180|OG000|Outcome|A-101 40%|A-101 40% Topical Solution
11209817|NCT02260180|OG001|Outcome|A-101 32.5%|A-101 32.5% Topical Solution
11209818|NCT02260180|OG002|Outcome|A-101 Vehicle Topical Solution|A-101 0% Topical Solution (vehicle)
11209819|NCT02260180|EG000|Reported Event|A-101 40%|"A-101 40% Topical Solution~A-101: Topical Solution"
11209820|NCT02260180|EG001|Reported Event|A-101 32.5%|"A-101 32.5% Topical Solution~A-101: Topical Solution"
11209821|NCT02260180|EG002|Reported Event|A-101 Vehicle Topical Solution|"A-101 0% Topical Solution (vehicle)~A-101: Topical Solution"
11209822|NCT02260258|BG000|Baseline|Rocuronium|"Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.~Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).~Rocuronium: Neuromuscular Blockade"
11209823|NCT02260258|BG001|Baseline|Usual Care|"Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.~Normal Saline: Normal Saline"
11209824|NCT02260258|BG002|Baseline|Total|Total of all reporting groups
11209825|NCT02260258|FG000|Participant Flow|Rocuronium|"Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.~Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).~Rocuronium: Neuromuscular Blockade"
11209826|NCT02260258|FG001|Participant Flow|Usual Care|"Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.~Normal Saline: Normal Saline"
11209827|NCT02260258|OG000|Outcome|Rocuronium|"Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.~Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).~Rocuronium: Neuromuscular Blockade"
11209828|NCT02260258|OG001|Outcome|Usual Care|"Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.~Normal Saline: Normal Saline"
11209829|NCT02260258|OG000|Outcome|Effect Estimate|Value of the interaction term between allocated treatment and time, which is presented as a ratio of geometric mean differences over 24 hours. Values above 1.0 favor the placebo arm.
11209830|NCT02260258|EG000|Reported Event|Rocuronium|"Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.~Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).~Rocuronium: Neuromuscular Blockade"
11209831|NCT02260258|EG001|Reported Event|Usual Care|"Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.~Normal Saline: Normal Saline"
11209832|NCT02260388|BG000|Baseline|Nortriptyline|"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.~Nortriptyline"
11209833|NCT02260388|BG001|Baseline|Duloxetine|"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.~Duloxetine"
11209834|NCT02260388|BG002|Baseline|Pregabalin|"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.~Pregabalin"
11209835|NCT02260388|BG003|Baseline|Mexiletine|"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.~Mexiletine"
11209836|NCT02260388|BG004|Baseline|Total|Total of all reporting groups
11209837|NCT02260388|FG000|Participant Flow|Nortriptyline|"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.~Nortriptyline"
11209838|NCT02260388|FG001|Participant Flow|Duloxetine|"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.~Duloxetine"
11209839|NCT02260388|FG002|Participant Flow|Pregabalin|"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.~Pregabalin"
11209840|NCT02260388|FG003|Participant Flow|Mexiletine|"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.~Mexiletine"
11209841|NCT02260388|OG000|Outcome|Nortriptyline|"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.~Nortriptyline"
11209842|NCT02260388|OG001|Outcome|Duloxetine|"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.~Duloxetine"
11209843|NCT02260388|OG002|Outcome|Pregabalin|"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.~Pregabalin"
11209844|NCT02260388|OG003|Outcome|Mexiletine|"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.~Mexiletine"
11209845|NCT02260388|EG000|Reported Event|Nortriptyline|"Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.~Nortriptyline"
11209846|NCT02260388|EG001|Reported Event|Duloxetine|"Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.~Duloxetine"
11209847|NCT02260388|EG002|Reported Event|Pregabalin|"Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.~Pregabalin"
11209848|NCT02260388|EG003|Reported Event|Mexiletine|"Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.~Mexiletine"
11209849|NCT02260401|BG000|Baseline|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
11209850|NCT02260401|BG001|Baseline|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
11209851|NCT02260401|BG002|Baseline|Total|Total of all reporting groups
11209852|NCT02260401|FG000|Participant Flow|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
11209853|NCT02260401|FG001|Participant Flow|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
11209854|NCT02260401|OG000|Outcome|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
11209855|NCT02260401|OG001|Outcome|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
11209856|NCT02260401|EG000|Reported Event|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
11209857|NCT02260401|EG001|Reported Event|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
11209858|NCT02260440|BG000|Baseline|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
11209859|NCT02260440|FG000|Participant Flow|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
11209860|NCT02260440|OG000|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
11209861|NCT02260440|EG000|Reported Event|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
11209862|NCT02260492|BG000|Baseline|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
11209863|NCT02260492|BG001|Baseline|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
10819706|NCT00049257|BG000|Baseline|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
10819707|NCT00049257|FG000|Participant Flow|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
11209864|NCT02260492|BG002|Baseline|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
10819708|NCT00049257|OG000|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
10819709|NCT00049257|EG000|Reported Event|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
10819710|NCT00049322|BG000|Baseline|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
11209865|NCT02260492|BG003|Baseline|Total|Total of all reporting groups
11209866|NCT02260492|FG000|Participant Flow|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
10819711|NCT00049322|BG001|Baseline|Arm II (TACE-O Arm )|Observation
10819712|NCT00049322|BG002|Baseline|Total|Total of all reporting groups
11209867|NCT02260492|FG001|Participant Flow|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
11209868|NCT02260492|FG002|Participant Flow|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
11209869|NCT02260492|OG000|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
11209870|NCT02260492|OG001|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
10819713|NCT00049322|FG000|Participant Flow|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
10819714|NCT00049322|FG001|Participant Flow|Arm II (TACE-O Arm )|Observation
10819715|NCT00049322|OG000|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
10819716|NCT00049322|OG001|Outcome|Arm II (TACE-O Arm )|Observation
10848069|NCT00288015|EG000|Reported Event|Bevacizumab|"Bevacizumab treatment until disease progression or intolerance~Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle)."
11209871|NCT02260492|OG002|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
11209872|NCT02260492|EG000|Reported Event|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
11209873|NCT02260492|EG001|Reported Event|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
11209874|NCT02260492|EG002|Reported Event|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
11209875|NCT02260531|BG000|Baseline|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle~Trastuzumab- IV administered once per cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209876|NCT02260531|BG001|Baseline|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209877|NCT02260531|BG002|Baseline|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209878|NCT02260531|BG003|Baseline|Total|Total of all reporting groups
11209879|NCT02260531|FG000|Participant Flow|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle~Trastuzumab- IV administered once per cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209880|NCT02260531|FG001|Participant Flow|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209881|NCT02260531|FG002|Participant Flow|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209882|NCT02260531|OG000|Outcome|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle~Trastuzumab- IV administered once per cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209883|NCT02260531|OG001|Outcome|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209884|NCT02260531|OG002|Outcome|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,~Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
11209885|NCT02260531|OG000|Outcome|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle, 60 mg per day~Trastuzumab- IV administered once per cycle, 8 mg/kg IV loading dose followed by 6 mg/kg IV Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209886|NCT02260531|OG001|Outcome|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~- Cabozantinib- orally administered daily per treatment cycle, 60 mg per day Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209887|NCT02260531|OG002|Outcome|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~- Cabozantinib- orally administered daily per treatment cycle, 60 mg per day Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209888|NCT02260531|OG000|Outcome|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle, 60 mg per day~Trastuzumab- IV administered once per cycle, 8 mg/kg IV loading dose followed by 6 mg/kg IV Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons.~Trastuzumab"
11209889|NCT02260531|OG000|Outcome|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle~Trastuzumab- IV administered once per cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,"
11209890|NCT02260531|OG001|Outcome|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,"
10819717|NCT00049322|OG000|Outcome|Arm I-bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
10819718|NCT00049322|OG001|Outcome|Arm II-chemoembolization|chemoembolization as part of standard of care
10819719|NCT00049322|EG000|Reported Event|Arm I|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
10819720|NCT00049322|EG001|Reported Event|Arm II|Patients do not receive bevacizumab
10848070|NCT00288054|BG000|Baseline|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
11209891|NCT02260531|OG002|Outcome|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~Cabozantinib- orally administered daily per treatment cycle~MRI- Baseline, Cycle 2 Day 1, and every 2 cycles~Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,"
11209892|NCT02260531|EG000|Reported Event|Cohort 1 - Cabozantinib, Trastuzumab for HER2+|"HER2-positive~Cabozantinib- orally administered daily per treatment cycle, 60 mg per day~Trastuzumab- IV administered once per cycle, 8 mg/kg IV loading dose followed by 6 mg/kg IV Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209893|NCT02260531|EG001|Reported Event|Cohort 2 - Cabozantinib for ER+ and/or PR+|"Hormone receptor-positive (ER+ and/or PR+)~- Cabozantinib- orally administered daily per treatment cycle, 60 mg per day Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209894|NCT02260531|EG002|Reported Event|Cohort 3 - Cabozantinib for ER-, PR-, HER2-|"Triple negative (ER-, PR-, HER2-)~- Cabozantinib- orally administered daily per treatment cycle, 60 mg per day Cycle duration equals 3 weeks. Patients are treated indefinitely based on unacceptable toxicity, disease progression, or withdrawal for other reasons."
11209895|NCT02260622|BG000|Baseline|Clopidogrel Plus Aspirin|"Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days"
11209896|NCT02260622|BG001|Baseline|Rivaroxaban Plus Aspirin|"Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily~rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days"
11209897|NCT02260622|BG002|Baseline|Total|Total of all reporting groups
11209898|NCT02260622|FG000|Participant Flow|Clopidogrel Plus Aspirin|"Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days"
11209899|NCT02260622|FG001|Participant Flow|Rivaroxaban Plus Aspirin|"Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily~rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days"
11209900|NCT02260622|OG000|Outcome|Clopidogrel Plus Aspirin|"Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days"
11209901|NCT02260622|OG001|Outcome|Rivaroxaban Plus Aspirin|"Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily~rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days"
11209902|NCT02260622|EG000|Reported Event|Clopidogrel Plus Aspirin|"Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days"
11209903|NCT02260622|EG001|Reported Event|Rivaroxaban Plus Aspirin|"Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily~rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days"
11209904|NCT02260635|BG000|Baseline|Evacetrapib|130 milligrams (mg) evacetrapib given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
11209905|NCT02260635|BG001|Baseline|Placebo|Placebo given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
11209906|NCT02260635|BG002|Baseline|Total|Total of all reporting groups
11209907|NCT02260635|FG000|Participant Flow|Evacetrapib|130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
10848071|NCT00288054|FG000|Participant Flow|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
10848072|NCT00288054|OG000|Outcome|Cetuximab + Chest Radiation Therapy|
10848073|NCT00288054|OG000|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
11209908|NCT02260635|FG001|Participant Flow|Placebo|Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
11209909|NCT02260635|OG000|Outcome|Evacetrapib|130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
11209910|NCT02260635|OG001|Outcome|Placebo|Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
11209911|NCT02260635|EG000|Reported Event|Evacetrapib Double Blind Treatment Period|130mg evacetrapib given PO once a day for 12 weeks.
11209912|NCT02260635|EG001|Reported Event|Placebo Double Blind Treatment Period|Placebo given PO once a day for 12 weeks
11209913|NCT02260635|EG002|Reported Event|Evacetrapib Open Label Extension|Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
11209914|NCT02260635|EG003|Reported Event|Placebo/Evacetrapib Open Label Extension|Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
11209915|NCT02260648|BG000|Baseline|Evacetrapib|130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209916|NCT02260648|BG001|Baseline|Placebo|Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209917|NCT02260648|BG002|Baseline|Ezetimibe|10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
11209918|NCT02260648|BG003|Baseline|Total|Total of all reporting groups
11209919|NCT02260648|FG000|Participant Flow|Evacetrapib|130 milligram (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209920|NCT02260648|FG001|Participant Flow|Placebo|Placebo and 10 mg atorvastatin administered orally (PO) once a day for 12 weeks.
11209921|NCT02260648|FG002|Participant Flow|Ezetimibe|10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
11209922|NCT02260648|OG000|Outcome|Evacetrapib|130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209923|NCT02260648|OG001|Outcome|Placebo|Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209924|NCT02260648|OG002|Outcome|Ezetimibe|10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
11209925|NCT02260648|EG000|Reported Event|Evacetrapib|130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209926|NCT02260648|EG001|Reported Event|Placebo|Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
11209927|NCT02260648|EG002|Reported Event|Ezetimibe|10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
11209928|NCT02260791|BG000|Baseline|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
11209929|NCT02260791|BG001|Baseline|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
11209930|NCT02260791|BG002|Baseline|Total|Total of all reporting groups
11209931|NCT02260791|FG000|Participant Flow|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
11209932|NCT02260791|FG001|Participant Flow|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
11209933|NCT02260791|OG000|Outcome|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
11209934|NCT02260791|OG001|Outcome|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
11209935|NCT02260791|EG000|Reported Event|FKB327|Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
11209936|NCT02260791|EG001|Reported Event|Humira®|Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
11209937|NCT02260804|BG000|Baseline|CT-P10|CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period
11209938|NCT02260804|BG001|Baseline|Rituxan|Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
11209939|NCT02260804|BG002|Baseline|Total|Total of all reporting groups
11209940|NCT02260804|FG000|Participant Flow|CT-P10|CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period
11209941|NCT02260804|FG001|Participant Flow|Rituxan|Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
11209942|NCT02260804|OG000|Outcome|CT-P10|CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period
11209943|NCT02260804|OG001|Outcome|Rituxan|Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
11209944|NCT02260804|EG000|Reported Event|CT-P10|CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period
11209945|NCT02260804|EG001|Reported Event|Rituxan|Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
11209946|NCT02260817|BG000|Baseline|11C-choline for Staging of Recurrent Prostate Cancer|"The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.~Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis."
11209947|NCT02260817|BG001|Baseline|11C-choline Comparison Study of CT and MR Modalities|"11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.~Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images~11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:~15 - millicuries (mCi) 11C-choline IV Injection~PET images skull base to mid thigh with 3 min per bed position~Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol~Fusion of PET and CT images~2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:~No IV contrast~High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs~Fusion of coronal and PET images"
11209948|NCT02260817|BG002|Baseline|Total|Total of all reporting groups
11209949|NCT02260817|FG000|Participant Flow|11C-choline for Staging of Recurrent Prostate Cancer|"The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.~Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis."
11209950|NCT02260817|FG001|Participant Flow|11C-choline Comparison Study of CT and MR Modalities|"11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.~Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images~11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:~15 - millicuries (mCi) 11C-choline IV Injection~PET images skull base to mid thigh with 3 min per bed position~Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol~Fusion of PET and CT images~2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:~No IV contrast~High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs~Fusion of coronal and PET images"
11209951|NCT02260817|OG000|Outcome|11C-choline for Staging of Recurrent Prostate Cancer|"The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.~Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis."
11209952|NCT02260817|OG001|Outcome|11C-choline Comparison Study of CT and MR Modalities|"11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.~Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images~11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:~15 - millicuries (mCi) 11C-choline IV Injection~PET images skull base to mid thigh with 3 min per bed position~Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol~Fusion of PET and CT images~2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:~No IV contrast~High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs~Fusion of coronal and PET images"
11209953|NCT02260817|EG000|Reported Event|11C-choline for Staging of Recurrent Prostate Cancer|"The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.~Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis."
11209954|NCT02260817|EG001|Reported Event|11C-choline Comparison Study of CT and MR Modalities|"11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.~Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images~11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:~15 - millicuries (mCi) 11C-choline IV Injection~PET images skull base to mid thigh with 3 min per bed position~Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol~Fusion of PET and CT images~2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:~No IV contrast~High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs~Fusion of coronal and PET images"
11209955|NCT02260882|BG000|Baseline|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
11209956|NCT02260882|BG001|Baseline|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
11209957|NCT02260882|BG002|Baseline|Total|Total of all reporting groups
11209958|NCT02260882|FG000|Participant Flow|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
11209959|NCT02260882|FG001|Participant Flow|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
11209960|NCT02260882|OG000|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
11209961|NCT02260882|OG000|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
11209962|NCT02260882|OG001|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
11209963|NCT02260882|EG000|Reported Event|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
11209964|NCT02260882|EG001|Reported Event|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
11209965|NCT02260921|BG000|Baseline|Iovera° Treatment|Treatment with the iovera° device administered by a trained investigator to treat knee pain.
11209966|NCT02260921|BG001|Baseline|Sham Treatment|Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
11209967|NCT02260921|BG002|Baseline|Total|Total of all reporting groups
11209968|NCT02260921|FG000|Participant Flow|Iovera° Treatment|Treatment with the iovera° device administered by a trained investigator to treat knee pain.
11209969|NCT02260921|FG001|Participant Flow|Sham Treatment|Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
11209970|NCT02260921|OG000|Outcome|Iovera° Treatment|Treatment with the iovera° device administered by a trained investigator to treat knee pain.
10848074|NCT00288054|OG000|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
11209971|NCT02260921|OG001|Outcome|Sham Treatment|Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
11209972|NCT02260921|EG000|Reported Event|Iovera° Treatment|Treatment with the iovera° device administered by a trained investigator to treat knee pain.
11209973|NCT02260921|EG001|Reported Event|Sham Treatment|Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
11209974|NCT02260934|BG000|Baseline|Rituximab/Cyclophosphamide (RC)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.
11209975|NCT02260934|BG001|Baseline|Rituximab/Cyclophosphamide/Belimumab (RCB)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
11209976|NCT02260934|BG002|Baseline|Total|Total of all reporting groups
10819721|NCT00049504|BG000|Baseline|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
10819722|NCT00049504|FG000|Participant Flow|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
11209977|NCT02260934|FG000|Participant Flow|Rituximab/Cyclophosphamide (RC)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.
11209978|NCT02260934|FG001|Participant Flow|Rituximab/Cyclophosphamide/Belimumab (RCB)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
11209979|NCT02260934|OG000|Outcome|Rituximab/Cyclophosphamide (RC)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.
11209980|NCT02260934|OG001|Outcome|Rituximab/Cyclophosphamide/Belimumab (RCB)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
11209981|NCT02260934|OG001|Outcome|Rituximab/Cyclophosphamide/Belimumab (RCB)|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.
11209982|NCT02260934|OG000|Outcome|Rituximab/Cyclophosphamide (RC)|The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.
11209983|NCT02260934|OG001|Outcome|Rituximab/Cyclophosphamide/Belimumab (RCB)|The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.
11209984|NCT02260934|OG000|Outcome|Rituximab/Cyclophosphamide (RC)|The safety population includes all participants who received at least one dose of study treatment.
11209985|NCT02260934|OG001|Outcome|Rituximab/Cyclophosphamide/Belimumab (RCB)|The safety population includes all participants who received at least one dose of study treatment.
11209986|NCT02260934|EG000|Reported Event|RC Group on Treatment|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.
11209987|NCT02260934|EG001|Reported Event|RCB Group on Treatment|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
10819723|NCT00049504|OG000|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
10819724|NCT00049504|EG000|Reported Event|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
11209988|NCT02260934|EG002|Reported Event|RC Group After Treatment Discontinuation|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.
11209989|NCT02260934|EG003|Reported Event|RCB Group After Treatment Discontinuation|Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
11209990|NCT02260986|BG000|Baseline|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11209991|NCT02260986|BG001|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
11209992|NCT02260986|BG002|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
11209993|NCT02260986|BG003|Baseline|Total|Total of all reporting groups
11209994|NCT02260986|FG000|Participant Flow|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11209995|NCT02260986|FG001|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
11209996|NCT02260986|FG002|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
11209997|NCT02260986|OG000|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51
11209998|NCT02260986|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
11209999|NCT02260986|OG002|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
11210000|NCT02260986|OG000|Outcome|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11210001|NCT02260986|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51.
11210002|NCT02260986|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
11210003|NCT02260986|OG002|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
11210004|NCT02260986|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
11210005|NCT02260986|EG000|Reported Event|Placebo qw|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
11210006|NCT02260986|EG001|Reported Event|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
10819725|NCT00049517|BG000|Baseline|Standard Daunorubicin (Induction Therapy)|"Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.~Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course."
10819726|NCT00049517|BG001|Baseline|High Dose Daunorubicin (Induction Therapy)|Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
10819727|NCT00049517|BG002|Baseline|Total|Total of all reporting groups
10819728|NCT00049517|FG000|Participant Flow|Standard Daunorubicin Then Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
10819729|NCT00049517|FG001|Participant Flow|High-dose Daunorubicin Then Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
10819730|NCT00049517|FG002|Participant Flow|Standard Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
10819731|NCT00049517|FG003|Participant Flow|High-dose Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
10819732|NCT00049517|FG004|Participant Flow|Standard Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
10819733|NCT00049517|FG005|Participant Flow|High-dose Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
10819734|NCT00049517|OG000|Outcome|Standard Daunorubicin|Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
10819735|NCT00049517|OG001|Outcome|High-dose Daunorubicin|Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
10819736|NCT00049517|OG000|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
10819737|NCT00049517|OG001|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
10848075|NCT00288054|EG000|Reported Event|Cetuximab + Chest Radiation Therapy|
11210007|NCT02260986|EG002|Reported Event|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51. Four participants received fewer injections of Dupilumab 300 mg in Dupilumab 300 qw arm, were analyzed in Dupilumab 300 mg q2w arm.
11210008|NCT02261428|BG000|Baseline|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
11210009|NCT02261428|BG001|Baseline|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
11210010|NCT02261428|BG002|Baseline|Total|Total of all reporting groups
11210011|NCT02261428|FG000|Participant Flow|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
11210012|NCT02261428|FG001|Participant Flow|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
11210013|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of attempts made wth catheter Tiemann.
11210014|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of attempts made wth Suction catheter.
11210015|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of time required to insert the trachea wth catheter Tiemann.
11210016|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of time required to insert the trachea wth Suction catheter
11210017|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.
11210018|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter
11210019|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.
11210020|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter
11210021|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
11210022|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
11210023|NCT02261428|OG000|Outcome|Catheter Tiemann|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
11210024|NCT02261428|OG001|Outcome|Suction Catheter|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
11210025|NCT02261428|OG000|Outcome|Catheter Tiemann|Presence of blood was found on Participants immediately after suctioning with catheter Tiemann
11210026|NCT02261428|OG001|Outcome|Suction Catheter|Presence of blood was found on Participants immediately after suctioning with Suction catheter
11210027|NCT02261428|EG000|Reported Event|Catheter Tiemann|Participants received nasotracheal suction with catheter Tiemann.
11210028|NCT02261428|EG001|Reported Event|Suction Catheter|Participants received nasotracheal suction with Suction catheter
11210029|NCT02261467|BG000|Baseline|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
11210030|NCT02261467|BG001|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210031|NCT02261467|BG002|Baseline|Total|Total of all reporting groups
11210032|NCT02261467|FG000|Participant Flow|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
11210033|NCT02261467|FG001|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210034|NCT02261467|OG000|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
11210035|NCT02261467|OG001|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210036|NCT02261467|EG000|Reported Event|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
11210037|NCT02261467|EG001|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210038|NCT02261493|BG000|Baseline|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
11210039|NCT02261493|BG001|Baseline|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210040|NCT02261493|BG002|Baseline|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210041|NCT02261493|BG003|Baseline|Total|Total of all reporting groups
11210042|NCT02261493|FG000|Participant Flow|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
11210043|NCT02261493|FG001|Participant Flow|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210044|NCT02261493|FG002|Participant Flow|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210045|NCT02261493|OG000|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
11210046|NCT02261493|OG001|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210047|NCT02261493|OG002|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210048|NCT02261493|EG000|Reported Event|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
11210049|NCT02261493|EG001|Reported Event|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210050|NCT02261493|EG002|Reported Event|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
11210051|NCT02261597|BG000|Baseline|Healthy Controls|Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen.
11210052|NCT02261597|BG001|Baseline|Insomnia Disorder|Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen.
11210053|NCT02261597|BG002|Baseline|Total|Total of all reporting groups
11210054|NCT02261597|FG000|Participant Flow|Healthy Controls|Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
11210055|NCT02261597|FG001|Participant Flow|Insomnia Disorder|Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen
11210056|NCT02261597|OG000|Outcome|Healthy Controls|Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
11210057|NCT02261597|OG001|Outcome|Insomnia Disorder|Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen
11210058|NCT02261597|EG000|Reported Event|Healthy Controls|Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
11210059|NCT02261597|EG001|Reported Event|Insomnia Disorder|Participants with the diagnosis of insomnia disorder (DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen.
11210060|NCT02261714|BG000|Baseline|TG01/GM-CSF and Gemcitabine|TG01: TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes TG01: For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surge
11210061|NCT02261714|FG000|Participant Flow|TG01/GM-CSF and Gemcitabine|"TG01: TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment.~TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.~Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes TG01: For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surge"
11210062|NCT02261714|OG000|Outcome|TG01/GM-CSF and Gemcitabine|"TG01: TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment.~TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.~Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes TG01: For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surge"
11210063|NCT02261714|OG000|Outcome|TG01/GM-CSF and Gemcitabine|TG01: TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes TG01: For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery.
11210064|NCT02261714|EG000|Reported Event|TG01/GM-CSF and Gemcitabine|TG01: TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes TG01: For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery.
11210065|NCT02261727|BG000|Baseline|Placebo|"Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily~Placebo (for Theophylline): One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)"
11210066|NCT02261727|BG001|Baseline|Low-dose Theophylline Arm|"Theophylline 100 mg twice daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily"
11210067|NCT02261727|BG002|Baseline|Theophylline and Prednisone Arm|"Theophylline 100 mg twice daily plus prednisone 5 mg once daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Prednisone: Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties"
11210068|NCT02261727|BG003|Baseline|Total|Total of all reporting groups
11210069|NCT02261727|FG000|Participant Flow|Low-dose Theophylline Arm|"Theophylline 100 mg twice daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily"
11210070|NCT02261727|FG001|Participant Flow|Placebo|"Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily~Placebo (for Theophylline): One tablet twice daily in arm 1 (theophylline placebo 1 twice daily + prednisone placebo 1 once daily)"
11210071|NCT02261727|FG002|Participant Flow|Theophylline and Prednisone Arm|"Theophylline 100 mg twice daily plus prednisone 5 mg once daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Prednisone: Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties"
11210072|NCT02261727|OG000|Outcome|Placebo|"Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily~Placebo (for Theophylline): One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)"
11210073|NCT02261727|OG001|Outcome|Low-dose Theophylline Arm|"Theophylline 100 mg twice daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily"
11210074|NCT02261727|OG002|Outcome|Theophylline and Prednisone Arm|"Theophylline 100 mg twice daily plus prednisone 5 mg once daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Prednisone: Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties"
11210075|NCT02261727|EG000|Reported Event|Placebo|"Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily~Placebo (for Theophylline): One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)"
11210076|NCT02261727|EG001|Reported Event|Low-dose Theophylline Arm|"Theophylline 100 mg twice daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Placebo (for prednisone): - Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily~- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily"
11210077|NCT02261727|EG002|Reported Event|Theophylline and Prednisone Arm|"Theophylline 100 mg twice daily plus prednisone 5 mg once daily~Theophylline: Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor~Prednisone: Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties"
11210078|NCT02261805|BG000|Baseline|Ganetespib and Doxorubicin|"Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle Ganetespib and doxorubicin~Ganetespib and doxorubicin: IV ganetespib and doxorubicin"
10969587|NCT00906698|FG003|Participant Flow|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
11210079|NCT02261805|FG000|Participant Flow|Ganetespib and Doxorubicin - Phase Ib Dose Level 1|Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210080|NCT02261805|FG001|Participant Flow|Ganetespib and Doxorubicin - Phase Ib Dose Level 2|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210081|NCT02261805|FG002|Participant Flow|Ganetespib and Doxorubicin - Phase II Expansion|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210082|NCT02261805|OG000|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 1|Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210083|NCT02261805|OG001|Outcome|Ganetespib and Doxorubicin - Phase Ib Dose Level 2|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210084|NCT02261805|OG002|Outcome|Ganetespib and Doxorubicin - Phase II Expansion|Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210085|NCT02261805|EG000|Reported Event|Ganetespib and Doxorubicin|Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
11210086|NCT02261818|BG000|Baseline|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
11210087|NCT02261818|FG000|Participant Flow|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide peer support to address depressive symptoms"
11210088|NCT02261818|OG000|Outcome|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
11210089|NCT02261818|EG000|Reported Event|Meetings With Peer Mentors|"Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.~Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms"
11210090|NCT02261948|BG000|Baseline|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210091|NCT02261948|BG001|Baseline|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210092|NCT02261948|BG002|Baseline|Total|Total of all reporting groups
11210093|NCT02261948|FG000|Participant Flow|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210094|NCT02261948|FG001|Participant Flow|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
10819738|NCT00049517|EG000|Reported Event|Standard Daunorubicin (Induction Therapy)|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Conditioning/Transplant:~Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover."
11210095|NCT02261948|OG000|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210096|NCT02261948|OG001|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210097|NCT02261948|EG000|Reported Event|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210098|NCT02261948|EG001|Reported Event|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
11210099|NCT02261961|BG000|Baseline|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a post-training Follow-up"
11210100|NCT02261961|BG001|Baseline|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approx 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a Post-training Follow-up"
11210101|NCT02261961|BG002|Baseline|Total|Total of all reporting groups
11244402|NCT02510794|EG000|Reported Event|Port Delivery System With Ranibizumab 10mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
10969588|NCT00906698|FG004|Participant Flow|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
11210102|NCT02261961|FG000|Participant Flow|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 weeks."
11210103|NCT02261961|FG001|Participant Flow|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks."
11210104|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: B"
11210105|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up"
11210106|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo"
11210107|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo"
11210108|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210109|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210110|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210111|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210112|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo"
11210113|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks."
11210114|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks."
11210115|NCT02261961|OG000|Outcome|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210116|NCT02261961|OG001|Outcome|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise."
11210117|NCT02261961|EG000|Reported Event|Nutritional Supplement|"Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training."
11210118|NCT02261961|EG001|Reported Event|Placebo|"Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.~TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo~Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle~Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.~Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approx 26 wks after completion of the ex training."
11210119|NCT02261974|BG000|Baseline|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
11210120|NCT02261974|BG001|Baseline|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
11210121|NCT02261974|BG002|Baseline|Total|Total of all reporting groups
11210122|NCT02261974|FG000|Participant Flow|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
11210123|NCT02261974|FG001|Participant Flow|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
11210124|NCT02261974|OG000|Outcome|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
11210125|NCT02261974|OG001|Outcome|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
11210126|NCT02261974|EG000|Reported Event|Active Viveve Treatment|"Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus~Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus"
11210127|NCT02261974|EG001|Reported Event|Sham Viveve Treatment|"Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus~Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus"
11210128|NCT02262039|BG000|Baseline|Conventional Pressure|15mmHg target pressure
11210129|NCT02262039|BG001|Baseline|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
11210130|NCT02262039|BG002|Baseline|Total|Total of all reporting groups
11210131|NCT02262039|FG000|Participant Flow|Conventional Pressure|15mmHg target pressure
11210132|NCT02262039|FG001|Participant Flow|Low Pressure (VTI)|"10mmHg target pressure~VTI = Valveless recirculating insufflation"
11210133|NCT02262039|OG000|Outcome|Conventional Pressure|15mmHg target pressure
11210134|NCT02262039|OG001|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
11210135|NCT02262039|EG000|Reported Event|Conventional Pressure|15mmHg target pressure
11210136|NCT02262039|EG001|Reported Event|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
11210137|NCT02262078|BG000|Baseline|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
11210138|NCT02262078|BG001|Baseline|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
11210139|NCT02262078|BG002|Baseline|Total|Total of all reporting groups
11210140|NCT02262078|FG000|Participant Flow|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
11210141|NCT02262078|FG001|Participant Flow|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
11210142|NCT02262078|OG000|Outcome|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
11210143|NCT02262078|OG001|Outcome|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
11210144|NCT02262078|EG000|Reported Event|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
11210145|NCT02262078|EG001|Reported Event|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
11210146|NCT02262130|BG000|Baseline|Omalizumab|"Omalizumab 300 mg W0, W4 and W8~Omalizumab"
11210147|NCT02262130|FG000|Participant Flow|Omalizumab|"Omalizumab 300 mg W0, W4 and W8~Omalizumab"
11210148|NCT02262130|OG000|Outcome|Omalizumab|"Omalizumab 300 mg W0, W4 and W8~Omalizumab"
11210149|NCT02262130|EG000|Reported Event|Omalizumab|"Omalizumab 300 mg W0, W4 and W8~Omalizumab"
11210150|NCT02262260|BG000|Baseline|Labeled Regime Arm|Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
11286224|NCT02885350|BG002|Baseline|Spinal Sufentanil|"5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
11210151|NCT02262260|BG001|Baseline|Wait and Extend Regime Arm|Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
11210152|NCT02262260|BG002|Baseline|Total|Total of all reporting groups
11210153|NCT02262260|FG000|Participant Flow|Labeled Regime Arm|Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
11210154|NCT02262260|FG001|Participant Flow|Wait and Extend Regime Arm|Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
11210155|NCT02262260|OG000|Outcome|Labeled Regime Arm|Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
11210156|NCT02262260|OG001|Outcome|Wait and Extend Regime Arm|Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
11210157|NCT02262260|EG000|Reported Event|Labeled Treatment Arm|Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month
11210158|NCT02262260|EG001|Reported Event|Wait and Extend Regimen Arm|Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
11210159|NCT02262364|BG000|Baseline|NStride APS|Subjects will receive an intra-articular injection of APS.
11210160|NCT02262364|FG000|Participant Flow|NStride APS|Subjects will receive an intra-articular injection of APS.
11210161|NCT02262364|OG000|Outcome|NStride APS|Subjects will receive an intra-articular injection of APS.
11210162|NCT02262364|EG000|Reported Event|NStride APS|Subjects will receive an intra-articular injection of APS.
11210163|NCT02262377|BG000|Baseline|Integrative Medical Group Visits|"9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting~Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum."
11210164|NCT02262377|BG001|Baseline|Standard of Care|primary care visits, which include medications and advice
11210165|NCT02262377|BG002|Baseline|Total|Total of all reporting groups
11210166|NCT02262377|FG000|Participant Flow|Integrative Medical Group Visits|"9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting~Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum."
11210167|NCT02262377|FG001|Participant Flow|Standard of Care|primary care visits, which include medications and advice
11210168|NCT02262377|OG000|Outcome|Integrative Medicine Group Visits|9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
11210169|NCT02262377|OG001|Outcome|Standard of Care-Control|Routine primary care visits, which include medications and advice
11210170|NCT02262377|EG000|Reported Event|Integrative Medical Group Visits|"9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting~Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum."
11210171|NCT02262377|EG001|Reported Event|Standard of Care|primary care visits, which include medications and advice
11210172|NCT02262377|EG002|Reported Event|All Participants|All participants included in the RCT.
11210173|NCT02262507|BG000|Baseline|Device Wearing|"All subjects who meet the study criteria and volunteer to participate will be included in the study.~Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins"
11210174|NCT02262507|FG000|Participant Flow|Device Wearing|"All subjects who meet the study criteria and volunteer to participate will be included in the study.~Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device."
11210175|NCT02262507|OG000|Outcome|Device Wearing|"All subjects who meet the study criteria and volunteer to participate will be included in the study.~Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device."
11210176|NCT02262507|OG001|Outcome|Non Device Wearing|same subjects tested while not wearing the device
11210177|NCT02262507|EG000|Reported Event|Device Wearing|"All subjects who meet the study criteria and volunteer to participate will be included in the study.~Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device."
11210178|NCT02262728|BG000|Baseline|Panel 1 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeters of mercury [mm Hg]) received simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210179|NCT02262728|BG001|Baseline|Panel 2 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210180|NCT02262728|BG002|Baseline|Total|Total of all reporting groups
11210181|NCT02262728|FG000|Participant Flow|Panel 1 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeters of mercury [mm Hg]) received simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210182|NCT02262728|FG001|Participant Flow|Panel 2 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210183|NCT02262728|OG000|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
11210184|NCT02262728|OG001|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
11210185|NCT02262728|EG000|Reported Event|Panel 1 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeters of mercury [mm Hg]) received simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210186|NCT02262728|EG001|Reported Event|Panel 2 SMV 150mg/DCV 60mg/SOF 400mg|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
11210187|NCT02262754|BG000|Baseline|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
11210188|NCT02262754|BG001|Baseline|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
11210189|NCT02262754|BG002|Baseline|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
11210190|NCT02262754|BG003|Baseline|Total|Total of all reporting groups
11210191|NCT02262754|FG000|Participant Flow|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
11210192|NCT02262754|FG001|Participant Flow|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
11210193|NCT02262754|FG002|Participant Flow|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
11210194|NCT02262754|OG000|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
11210195|NCT02262754|OG001|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
11210196|NCT02262754|OG002|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
11210197|NCT02262754|OG000|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
11210198|NCT02262754|OG000|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
11210199|NCT02262754|EG000|Reported Event|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
11210200|NCT02262754|EG001|Reported Event|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
11210201|NCT02262754|EG002|Reported Event|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
11210202|NCT02263014|BG000|Baseline|CPM Group|CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery.
11210203|NCT02263014|BG001|Baseline|No CPM Group|No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
11210204|NCT02263014|BG002|Baseline|Total|Total of all reporting groups
11210205|NCT02263014|FG000|Participant Flow|CPM Group|Contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.
11210206|NCT02263014|FG001|Participant Flow|No CPM Group|No CPM performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
11210207|NCT02263014|OG000|Outcome|CPM Group|CPM along with scheduled mastectomy. Questionnaires completed at baseline (pre-surgery) and at 1, 6, and 12 months post-surgery.
11210208|NCT02263014|OG001|Outcome|No CPM Group|No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at baseline (pre-surgery), and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
11210209|NCT02263014|OG000|Outcome|CPM Group|Contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.
11210210|NCT02263014|OG001|Outcome|No CPM Group|No CPM performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
11210211|NCT02263014|EG000|Reported Event|CPM Group|CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.
11210212|NCT02263014|EG001|Reported Event|No CPM Group|No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
11210213|NCT02263040|BG000|Baseline|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine"
11210214|NCT02263040|BG001|Baseline|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine"
11210215|NCT02263040|BG002|Baseline|Total|Total of all reporting groups
11210216|NCT02263040|FG000|Participant Flow|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine~Either 2014/15 OR 2015/16"
11210217|NCT02263040|FG001|Participant Flow|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine~Either: 2014/15 OR 2015/16"
11210218|NCT02263040|OG000|Outcome|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine~Either season: 2014/15 OR 2015/16"
11210219|NCT02263040|OG001|Outcome|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine~Either season: 2014/15 OR 2015/16"
11210220|NCT02263040|OG000|Outcome|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine~either 2014/15 OR 2015/16"
11210221|NCT02263040|OG001|Outcome|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine Either: 2014/15 OR 2015/16"
11210222|NCT02263040|OG000|Outcome|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine~Either 2014/15 OR 2015/16"
11210223|NCT02263040|OG001|Outcome|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine~Either: 2014/15 OR 2015/16"
11210224|NCT02263040|EG000|Reported Event|High Dose Fluzone|"Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain~Fluzone High-Dose: Influenza vaccine~Either season: 2014/15 OR 2015/16"
11210225|NCT02263040|EG001|Reported Event|Fluzone (Standard Dose)|"Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults~Fluzone (standard dose): Influenza vaccine~Either season: 2014/15 OR 2015/16"
11210226|NCT02263079|BG000|Baseline|Peg-IFN-Alfa-2A + Lamivudine or Entecavir|Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks.
11210227|NCT02263079|BG001|Baseline|Untreated Control Participants|Untreated control participants were observed up to 80 weeks.
11210228|NCT02263079|BG002|Baseline|Peg-INF-Alfa-2A Monotherapy|Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks.
11210229|NCT02263079|BG003|Baseline|Total|Total of all reporting groups
11210230|NCT02263079|FG000|Participant Flow|Peg-IFN-Alfa-2A + Lamivudine or Entecavir|Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks.
11210231|NCT02263079|FG001|Participant Flow|Untreated Control Participants|Untreated control participants were observed up to 80 weeks.
11210232|NCT02263079|FG002|Participant Flow|Peg-INF-Alfa-2A Monotherapy|Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks.
11210233|NCT02263079|OG000|Outcome|Peg-IFN-Alfa-2A + Lamivudine or Entecavir|Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks.
11210234|NCT02263079|OG001|Outcome|Untreated Control Participants|Untreated control participants were observed up to 80 weeks.
11210235|NCT02263079|OG000|Outcome|Untreated Control Participants|Untreated control participants were observed up to 80 weeks.
11210236|NCT02263079|EG000|Reported Event|Peg-IFN-Alfa-2A + Lamivudine or Entecavir|Participants received lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks.
11210237|NCT02263079|EG001|Reported Event|Untreated Control Participants|Untreated control participants were observed up to 80 weeks.
11210238|NCT02263079|EG002|Reported Event|Peg-INF-Alfa-2A Monotherapy|Participants received Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks.
11210239|NCT02263118|BG000|Baseline|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
11210240|NCT02263118|BG001|Baseline|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
11210241|NCT02263118|BG002|Baseline|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
11210242|NCT02263118|BG003|Baseline|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
11210243|NCT02263118|BG004|Baseline|Total|Total of all reporting groups
11210244|NCT02263118|FG000|Participant Flow|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
11210245|NCT02263118|FG001|Participant Flow|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
11210246|NCT02263118|FG002|Participant Flow|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
11210247|NCT02263118|FG003|Participant Flow|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
11210248|NCT02263118|OG000|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
11210249|NCT02263118|OG001|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
11210250|NCT02263118|OG002|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
11210251|NCT02263118|OG003|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
11210252|NCT02263118|OG000|Outcome|Uni-directional SMS|"There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
11210253|NCT02263118|OG003|Outcome|Control Group|"There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
11210254|NCT02263118|EG000|Reported Event|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
11210255|NCT02263118|EG001|Reported Event|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
11210256|NCT02263118|EG002|Reported Event|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
11210257|NCT02263118|EG003|Reported Event|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
11210258|NCT02263131|BG000|Baseline|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
11210259|NCT02263131|BG001|Baseline|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
11210260|NCT02263131|BG002|Baseline|Total|Total of all reporting groups
11210261|NCT02263131|FG000|Participant Flow|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
11210262|NCT02263131|FG001|Participant Flow|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
11210263|NCT02263131|OG000|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
11210264|NCT02263131|OG001|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
11210265|NCT02263131|EG000|Reported Event|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
11210266|NCT02263131|EG001|Reported Event|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
11210267|NCT02263326|BG000|Baseline|Dolutegravir Plus Lamivudine|"dolutegravir 50 mg plus lamivudine 300 mg once daily~dolutegravir: 50 mg tablet by mouth once daily for 48 weeks~lamivudine: 300 mg tablet by mouth once daily for 48 weeks"
11210268|NCT02263326|BG001|Baseline|Continue Current ART Regimen|"Continue current DHHS recommended or alternative three-drug antiretroviral regimen~Continue current antiretroviral regimen: Continue current DHHS recommended or alternative three-drug antiretroviral regimen"
11210269|NCT02263326|BG002|Baseline|Total|Total of all reporting groups
11210270|NCT02263326|FG000|Participant Flow|Dolutegravir Plus Lamivudine|"dolutegravir 50 mg plus lamivudine 300 mg once daily~dolutegravir: 50 mg tablet by mouth once daily for 48 weeks~lamivudine: 300 mg tablet by mouth once daily for 48 weeks"
11210271|NCT02263326|FG001|Participant Flow|Continue Current ART Regimen|"Continue current DHHS recommended or alternative three-drug antiretroviral regimen~Continue current antiretroviral regimen: Continue current DHHS recommended or alternative three-drug antiretroviral regimen"
11210272|NCT02263326|OG000|Outcome|Dolutegravir Plus Lamivudine|"dolutegravir 50 mg plus lamivudine 300 mg once daily~dolutegravir: 50 mg tablet by mouth once daily for 48 weeks~lamivudine: 300 mg tablet by mouth once daily for 48 weeks"
11210273|NCT02263326|OG001|Outcome|Continue Current ART Regimen|"Continue current DHHS recommended or alternative three-drug antiretroviral regimen~Continue current antiretroviral regimen: Continue current DHHS recommended or alternative three-drug antiretroviral regimen"
11210274|NCT02263326|EG000|Reported Event|Dolutegravir Plus Lamivudine|"dolutegravir 50 mg plus lamivudine 300 mg once daily~dolutegravir: 50 mg tablet by mouth once daily for 48 weeks~lamivudine: 300 mg tablet by mouth once daily for 48 weeks"
11210275|NCT02263326|EG001|Reported Event|Continue Current ART Regimen|"Continue current DHHS recommended or alternative three-drug antiretroviral regimen~Continue current antiretroviral regimen: Continue current DHHS recommended or alternative three-drug antiretroviral regimen"
11210276|NCT02263547|BG000|Baseline|Teriflunomide Elimination With Colestipol|"teriflunomide~Colestipol"
11210277|NCT02263547|FG000|Participant Flow|Teriflunomide Elimination With Colestipol|"teriflunomide~Colestipol"
11210278|NCT02263547|OG000|Outcome|Teriflunomide Elimination With Colestipol|"teriflunomide~Colestipol"
11210279|NCT02263547|EG000|Reported Event|Teriflunomide Elimination With Colestipol|"teriflunomide~Colestipol"
11210280|NCT02263833|BG000|Baseline|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
11210281|NCT02263833|FG000|Participant Flow|Overall Participants|Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
11210282|NCT02263833|OG000|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
11210283|NCT02263833|EG000|Reported Event|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
11210284|NCT02263911|BG000|Baseline|Overall Study|All randomized participants.
11210285|NCT02263911|FG000|Participant Flow|Baricitinib Dosing Sequence 1|Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
11210286|NCT02263911|FG001|Participant Flow|Baricitinib Dosing Sequence 2|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
11210287|NCT02263911|FG002|Participant Flow|Baricitinib Dosing Sequence 3|Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
11210288|NCT02263911|FG003|Participant Flow|Baricitinib Dosing Sequence 4|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
11210289|NCT02263911|OG000|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
11210290|NCT02263911|OG001|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210291|NCT02263911|OG002|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210292|NCT02263911|OG003|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210293|NCT02263911|OG004|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
11210294|NCT02263911|OG000|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
11210295|NCT02263911|OG000|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210296|NCT02263911|EG000|Reported Event|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
11210297|NCT02263911|EG001|Reported Event|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210298|NCT02263911|EG002|Reported Event|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210299|NCT02263911|EG003|Reported Event|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
11210300|NCT02263911|EG004|Reported Event|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
11210301|NCT02264249|BG000|Baseline|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210302|NCT02264249|BG001|Baseline|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210303|NCT02264249|BG002|Baseline|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210304|NCT02264249|BG003|Baseline|Total|Total of all reporting groups
11210305|NCT02264249|FG000|Participant Flow|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210306|NCT02264249|FG001|Participant Flow|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210307|NCT02264249|FG002|Participant Flow|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210308|NCT02264249|OG000|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210309|NCT02264249|OG001|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210310|NCT02264249|OG002|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210311|NCT02264249|EG000|Reported Event|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
10819739|NCT00049517|EG001|Reported Event|High Dose Daunorubicin (Induction Therapy)|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.~Conditioning/Transplant:~Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I."
10819740|NCT00049530|BG000|Baseline|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
10819741|NCT00049530|FG000|Participant Flow|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
10819742|NCT00049530|OG000|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
11210312|NCT02264249|EG001|Reported Event|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210313|NCT02264249|EG002|Reported Event|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
11210314|NCT02264353|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Donepezil 10mg tablet or Placebo tablet (matching Donepezil 10mg) before sleep
11210315|NCT02264353|FG000|Participant Flow|Donepezil Then Placebo|"Sleep data with Donepezil given during Visit 1 followed by a 14 day washout period followed by Sleep data with Placebo given during Visit 2~Donepezil: Donepezil 10mg before sleep"
11210316|NCT02264353|FG001|Participant Flow|Placebo Then Donepezil|"Sleep data with Placebo given during Visit 1 followed by a 14 day washout period followed by Sleep data with Donepezil given during Visit 2~placebo: One piece of placebo before sleep"
11210317|NCT02264353|OG000|Outcome|Donepezil|"Sleep data with Donepezil given~Donepezil: Donepezil 10mg before sleep"
11210318|NCT02264353|OG001|Outcome|Placebo|"Sleep data with Placebo given~placebo: One piece of placebo before sleep"
11210319|NCT02264353|EG000|Reported Event|Donepezil|"Sleep data with Donepezil given~Donepezil: Donepezil 10mg before sleep"
11210320|NCT02264353|EG001|Reported Event|Placebo|"Sleep data with Placebo given~placebo: One piece of placebo before sleep"
11210321|NCT02264574|BG000|Baseline|IBR+OB|"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity."
11210322|NCT02264574|BG001|Baseline|CLB+OB|"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity."
11210323|NCT02264574|BG002|Baseline|Total|Total of all reporting groups
11210324|NCT02264574|FG000|Participant Flow|IBR+OB|"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity."
11210325|NCT02264574|FG001|Participant Flow|CLB+OB|"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity."
11210326|NCT02264574|OG000|Outcome|IBR+OB|"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity."
11210327|NCT02264574|OG001|Outcome|CLB+OB|"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity."
10819743|NCT00049530|EG000|Reported Event|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
11210328|NCT02264574|EG000|Reported Event|IBR+OB|"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity."
11210329|NCT02264574|EG001|Reported Event|CLB+OB|"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.~Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity."
11210330|NCT02264639|BG000|Baseline|Cohort 1 Single- and Multiple-dose Phase|"Cohort 1 single-dose phase: Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.~Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56)."
11210331|NCT02264639|BG001|Baseline|Cohort 2 Single- and Multiple-dose Phase|"Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.~Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56)."
11210332|NCT02264639|BG002|Baseline|Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase|"Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.~Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).~Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).~Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210333|NCT02264639|BG003|Baseline|Cohorts 3 and 4 Multiple-dose Phase|"Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).~Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210334|NCT02264639|BG004|Baseline|Cohort 4 Multiple-dose Phase|"Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210335|NCT02264639|BG005|Baseline|Total|Total of all reporting groups
11210336|NCT02264639|FG000|Participant Flow|Cohort 1 Single- and Multiple-dose Phase|"Cohort 1 single-dose phase: Subjects received a single subcutaneous (SC) dose of 25 milligrams (mg) pegcetacoplan on Day 1.~Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56)."
11210337|NCT02264639|FG001|Participant Flow|Cohort 2 Single- and Multiple-dose Phase|"Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.~Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56)."
11210338|NCT02264639|FG002|Participant Flow|Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase|"Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.~Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).~Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).~Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210339|NCT02264639|FG003|Participant Flow|Cohorts 3 and 4 Multiple-dose Phase|"Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).~Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210340|NCT02264639|FG004|Participant Flow|Cohort 4 Multiple-dose Phase|"Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:~Part 1: Subjects received daily doses of pegcetacoplan for 28 days.~Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.~Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.~Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.~After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210341|NCT02264639|OG000|Outcome|Cohort 1 Single-dose Phase|Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
11210342|NCT02264639|OG001|Outcome|Cohort 2 Single-dose Phase|Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
11210343|NCT02264639|OG000|Outcome|Cohort 1 Multiple-dose Phase|Subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
11210344|NCT02264639|OG001|Outcome|Cohort 2 Multiple-dose Phase|Subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
11210345|NCT02264639|OG002|Outcome|Cohort 3 Multiple-dose Phase|Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
11210346|NCT02264639|OG003|Outcome|Cohort 4 Multiple-dose Phase|"Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).~After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210347|NCT02264639|OG000|Outcome|Cohort 4 Multiple-dose Phase|"Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).~After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210348|NCT02264639|EG000|Reported Event|Cohort 1 Single-dose Phase|Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
11210349|NCT02264639|EG001|Reported Event|Cohort 2 Single-dose Phase|Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
11210350|NCT02264639|EG002|Reported Event|Cohort 1 Multiple-dose Phase|Subjects received pegcetacoplan 5 mg/day as SC dose for 28 days (from Day 29 to Day 56).
11210351|NCT02264639|EG003|Reported Event|Cohort 2 Multiple-dose Phase|Subjects received pegcetacoplan 30 mg/day as SC dose for 28 days (from Day 29 to Day 56).
11210352|NCT02264639|EG004|Reported Event|Cohort 3 Multiple-dose Phase|Subjects received pegcetacoplan 180 mg/day as SC dose for 28 days (from Day 1 to Day 28).
11210353|NCT02264639|EG005|Reported Event|Cohort 4 Multiple-dose Phase|"Subjects received pegcetacoplan 270 mg/day as SC dose for up to 729 days (from Day 1 up to Day 729).~After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability."
11210354|NCT02264821|BG000|Baseline|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
11210355|NCT02264821|BG001|Baseline|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
11210356|NCT02264821|BG002|Baseline|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
11210357|NCT02264821|BG003|Baseline|Total|Total of all reporting groups
11210358|NCT02264821|FG000|Participant Flow|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
11210359|NCT02264821|FG001|Participant Flow|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
11210360|NCT02264821|FG002|Participant Flow|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
11210361|NCT02264821|OG000|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
11210362|NCT02264821|OG001|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
11210363|NCT02264821|OG002|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
11210364|NCT02264821|EG000|Reported Event|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
11210365|NCT02264821|EG001|Reported Event|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
11210366|NCT02264821|EG002|Reported Event|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
11286225|NCT02885350|BG003|Baseline|Epidural Sufentanil|"20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
11210367|NCT02264990|BG000|Baseline|Investigator's Choice Chemotherapy|"Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:~Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²~Cisplatin 75 mg/m² + pemetrexed 500 mg/m²~Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210368|NCT02264990|BG001|Baseline|Veliparib + Carboplatin + Paclitaxel|"Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210369|NCT02264990|BG002|Baseline|Total|Total of all reporting groups
11210370|NCT02264990|FG000|Participant Flow|Investigator's Choice Chemotherapy|"Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:~Carboplatin at an area under the curve (AUC) of 6 mg/mL*min + paclitaxel 200 mg/m²~Cisplatin 75 mg/m² + pemetrexed 500 mg/m²~Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210371|NCT02264990|FG001|Participant Flow|Veliparib + Carboplatin + Paclitaxel|"Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210372|NCT02264990|OG000|Outcome|Investigator's Choice Chemotherapy|"Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:~Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²~Cisplatin 75 mg/m² + pemetrexed 500 mg/m²~Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210373|NCT02264990|OG001|Outcome|Veliparib + Carboplatin + Paclitaxel|"Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210374|NCT02264990|OG000|Outcome|Investigator's Choice Chemotherapy|"Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:~Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²~Cisplatin 75 mg/m² + pemetrexed 500 mg/m²~Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210375|NCT02264990|EG000|Reported Event|Investigator's Choice Chemotherapy|"Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:~Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²~Cisplatin 75 mg/m² + pemetrexed 500 mg/m²~Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210376|NCT02264990|EG001|Reported Event|Veliparib + Carboplatin + Paclitaxel|"Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.~After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred."
11210377|NCT02265224|BG000|Baseline|Enrolled Subjects Set|According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule. Two single doses of 600 mg of NAC (one with test and one with reference formulation) were administered to each volunteer in two subsequent study periods (morning of day 1), separated by a wash-out interval of at least 5 days.
11210378|NCT02265224|FG000|Participant Flow|Enrolled Subjects Set|According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule.Two single doses of 600 mg of NAC (one with test and one with reference formulation) were administered to each volunteer in two subsequent study periods (morning of day 1), separated by a wash-out interval of at least 5 days.
11210379|NCT02265224|OG000|Outcome|Test|N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
11210380|NCT02265224|OG001|Outcome|Reference|N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose). The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
11210381|NCT02265224|OG000|Outcome|Enrolled Subjects Set|According to the crossover design, all the enrolled subjects received both NAC formulations based on the randomization schedule.
11210382|NCT02265224|EG000|Reported Event|Test - Reference|"N-acetylcysteine (NAC) 600 mg uncoated tablet (single dose) followed by NAC 600 mg film-coated tablet (single dose)~N-acetylcysteine: The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h."
11286226|NCT02885350|BG004|Baseline|Total|Total of all reporting groups
11210383|NCT02265224|EG001|Reported Event|Reference - Test|"N-acetylcysteine (NAC) 600 mg film-coated tablet (single dose) followed by NAC 600 mg uncoated tablet (single dose)~N-acetylcysteine: The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h."
11210384|NCT02265237|BG000|Baseline|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
11210385|NCT02265237|BG001|Baseline|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
11210386|NCT02265237|BG002|Baseline|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
11210387|NCT02265237|BG003|Baseline|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
11210388|NCT02265237|BG004|Baseline|Total|Total of all reporting groups
11210389|NCT02265237|FG000|Participant Flow|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
11210390|NCT02265237|FG001|Participant Flow|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
11210391|NCT02265237|FG002|Participant Flow|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
11210392|NCT02265237|FG003|Participant Flow|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
11210393|NCT02265237|OG000|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
11210394|NCT02265237|OG001|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
11210395|NCT02265237|OG002|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
11210396|NCT02265237|OG000|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
11210397|NCT02265237|OG001|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
11210398|NCT02265237|EG000|Reported Event|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
11210399|NCT02265237|EG001|Reported Event|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
11210400|NCT02265237|EG002|Reported Event|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
11210401|NCT02265237|EG003|Reported Event|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
11210402|NCT02265341|BG000|Baseline|Treatment (Ponatinib Hydrochloride)|Patients receive ponatinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11210403|NCT02265341|FG000|Participant Flow|Treatment (Ponatinib Hydrochloride)|Patients receive ponatinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11210404|NCT02265341|OG000|Outcome|Treatment (Ponatinib Hydrochloride)|Patients receive ponatinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11210405|NCT02265341|EG000|Reported Event|Treatment (Ponatinib Hydrochloride)|Patients receive ponatinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11210406|NCT02265510|BG000|Baseline|Phase 1a TGA - INCB052793 15 mg|INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210407|NCT02265510|BG001|Baseline|Phase 1a TGA - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210408|NCT02265510|BG002|Baseline|Phase 1a TGA - INCB052793 35 mg|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210409|NCT02265510|BG003|Baseline|Phase 1a TGA - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210410|NCT02265510|BG004|Baseline|Phase 1a TGA - INCB052793 75 mg|INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210411|NCT02265510|BG005|Baseline|Phase 1a TGA - INCB052793 100 mg|INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210412|NCT02265510|BG006|Baseline|Phase 1a TGB - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210413|NCT02265510|BG007|Baseline|Phase 1a TGB - INCB052793 35 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210414|NCT02265510|BG008|Baseline|Phase 1a TGB - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210415|NCT02265510|BG009|Baseline|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
11210416|NCT02265510|BG010|Baseline|Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210417|NCT02265510|BG011|Baseline|Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210418|NCT02265510|BG012|Baseline|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210419|NCT02265510|BG013|Baseline|• Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210420|NCT02265510|BG014|Baseline|Total|Total of all reporting groups
11210421|NCT02265510|FG000|Participant Flow|Phase 1a TGA - INCB052793 15 mg|INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210422|NCT02265510|FG001|Participant Flow|Phase 1a TGA - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria
11210423|NCT02265510|FG002|Participant Flow|Phase 1a TGA - INCB052793 35 mg|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria.
11210424|NCT02265510|FG003|Participant Flow|Phase 1a TGA - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210425|NCT02265510|FG004|Participant Flow|Phase 1a TGA - INCB052793 75 mg|INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210426|NCT02265510|FG005|Participant Flow|Phase 1a TGA - INCB052793 100 mg|INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210427|NCT02265510|FG006|Participant Flow|Phase 1a TGB - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21day cycles until they met treatment discontinuation criteria.
11210428|NCT02265510|FG007|Participant Flow|Phase 1a TGB - INCB052793 35 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210429|NCT02265510|FG008|Participant Flow|Phase 1a TGB - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210430|NCT02265510|FG009|Participant Flow|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
11210431|NCT02265510|FG010|Participant Flow|Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210432|NCT02265510|FG011|Participant Flow|Hase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle.
11210433|NCT02265510|FG012|Participant Flow|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210434|NCT02265510|FG013|Participant Flow|Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210435|NCT02265510|OG000|Outcome|Phase 1a TGA - INCB052793 15 mg|INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210436|NCT02265510|OG001|Outcome|Phase 1a TGA - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210437|NCT02265510|OG002|Outcome|Phase 1a TGA - INCB052793 35 mg|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210438|NCT02265510|OG003|Outcome|Phase 1a TGA - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210439|NCT02265510|OG004|Outcome|Phase 1a TGA - INCB052793 75 mg|INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210440|NCT02265510|OG005|Outcome|Phase 1a TGA - INCB052793 100 mg|INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210441|NCT02265510|OG006|Outcome|Phase 1a TGB - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210442|NCT02265510|OG007|Outcome|Phase 1a TGB - INCB052793 35 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210443|NCT02265510|OG008|Outcome|Phase 1a TGB - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
11210444|NCT02265510|OG009|Outcome|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
11210445|NCT02265510|OG010|Outcome|Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210446|NCT02265510|OG011|Outcome|Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
11210447|NCT02265510|OG000|Outcome|Phase 2 Cohort I-INCB052793 +Azacytidine (AML)|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210448|NCT02265510|OG001|Outcome|Phase 2 Cohort I-INCB052793 +Azacytidine (MDS)|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210449|NCT02265510|OG002|Outcome|Phase 2 Cohort J-Itacitinib +Azacitidine (AML)|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210450|NCT02265510|OG003|Outcome|Phase 2 Cohort J-Itacitinib +Azacitidine (MDS)|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
11210451|NCT02265510|OG000|Outcome|Phase 1a TGA - INCB052793 in Solid Tumors|INCB052793 tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210452|NCT02265510|OG001|Outcome|Phase 1a TGB - INCB052793 in Lymphoma|INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210453|NCT02265510|OG002|Outcome|Phase 1a TGB - INCB052793 in MDS/MPN|INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210454|NCT02265510|OG003|Outcome|Phase 1a TGB - INCB052793 in MM|INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
11210455|NCT02265510|OG004|Outcome|Phase 1b Cohort B - INCB052793 + Dexamethasone in MM|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
11210456|NCT02265510|OG005|Outcome|Phase 1b Cohort F-INCB052793 +Azacytidine in AML|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210457|NCT02265510|OG006|Outcome|Phase 1b Cohort F-INCB052793 +Azacytidine in MDS|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210458|NCT02265510|OG007|Outcome|Phase 1b Cohort F-INCB052793 +Azacytidine in MDS/MPN|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210459|NCT02265510|OG000|Outcome|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210460|NCT02265510|OG001|Outcome|Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210461|NCT02265510|OG000|Outcome|Phase 1a TGA - INCB052793 15 mg|INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
11210462|NCT02265510|OG001|Outcome|Phase 1a TGA - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
11210463|NCT02265510|OG002|Outcome|Phase 1a TGA - INCB052793 35 mg|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
11210464|NCT02265510|OG003|Outcome|Phase 1a TGA - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
11210465|NCT02265510|OG004|Outcome|Phase 1a TGA - INCB052793 75 mg|INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
11210466|NCT02265510|OG005|Outcome|Phase 1a TGA - INCB052793 100 mg|INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
11210467|NCT02265510|OG006|Outcome|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
11210468|NCT02265510|OG007|Outcome|Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210469|NCT02265510|OG008|Outcome|Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210470|NCT02265510|OG009|Outcome|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210471|NCT02265510|OG006|Outcome|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle .
11210472|NCT02265510|OG009|Outcome|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
11210473|NCT02265510|OG000|Outcome|Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
11210474|NCT02265510|OG000|Outcome|Phase 1a Part 2 Expasion Cohort- INCB052793|INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
11210475|NCT02265510|EG000|Reported Event|Phase 1a TGA - INCB052793 15 mg|INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
11210476|NCT02265510|EG001|Reported Event|Phase 1a TGA - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
11210477|NCT02265510|EG002|Reported Event|Phase 1a TGA - INCB052793 35 mg|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
11210478|NCT02265510|EG003|Reported Event|Phase 1a TGA - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
11210479|NCT02265510|EG004|Reported Event|Phase 1a TGA - INCB052793 75 mg|INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
11210480|NCT02265510|EG005|Reported Event|Phase 1a TGA - INCB052793 100 mg|INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
11210481|NCT02265510|EG006|Reported Event|Phase 1a TGB - INCB052793 25 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 248.7 days).
11210482|NCT02265510|EG007|Reported Event|Phase 1a TGB - INCB052793 35 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 342.8 days).
11210483|NCT02265510|EG008|Reported Event|Phase 1a TGB - INCB052793 50 mg|INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 76.3 days).
11210484|NCT02265510|EG009|Reported Event|Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 28-day cycle (Up to mean duration of exposure of approximately 53.6 days).
11210485|NCT02265510|EG010|Reported Event|Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2|INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 151.2 days).
11210486|NCT02265510|EG011|Reported Event|Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 142.1 days).
11210487|NCT02265510|EG012|Reported Event|Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2|INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 86.2 days).
11210488|NCT02265510|EG013|Reported Event|Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2|Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 143 days).
11210489|NCT02265705|BG000|Baseline|Placebo|"Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.~Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.~Placebo: Administered orally"
11210490|NCT02265705|BG001|Baseline|Baricitinib|"4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.~Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.~Baricitinib: Administered orally"
11210491|NCT02265705|BG002|Baseline|Total|Total of all reporting groups
11210492|NCT02265705|FG000|Participant Flow|Placebo Treatment Period Week 0-24|Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210493|NCT02265705|FG001|Participant Flow|4 Milligrams (mg) Baricitinib Treatment Period Week 0-24|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210494|NCT02265705|FG002|Participant Flow|Rescue Treatment Period Week 16-52|All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
11210495|NCT02265705|FG003|Participant Flow|Placebo to Baricitinib Treatment Period Week 24 - 52|At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210496|NCT02265705|FG004|Participant Flow|4 mg Baricitinib Treatment Period Week 24-52|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210497|NCT02265705|FG005|Participant Flow|Placebo Follow-up Period|Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210498|NCT02265705|FG006|Participant Flow|4 mg Baricitinib Follow-up Period|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210499|NCT02265705|OG000|Outcome|Placebo|Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210500|NCT02265705|OG001|Outcome|Baricitinib|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210501|NCT02265705|EG000|Reported Event|Placebo Treatment Period Week 0-24|Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210502|NCT02265705|EG001|Reported Event|4 Milligrams (mg) Baricitinib Treatment Period Week 0-24|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210503|NCT02265705|EG002|Reported Event|Rescue Treatment Period Week 16-52|All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
11210504|NCT02265705|EG003|Reported Event|Placebo to Baricitinib Treatment Period Week 24 - 52|At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210505|NCT02265705|EG004|Reported Event|4 mg Baricitinib Treatment Period Week 24-52|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210506|NCT02265705|EG005|Reported Event|Placebo Follow-up Period|Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
11210507|NCT02265705|EG006|Reported Event|4 mg Baricitinib Follow-up Period|4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
11210508|NCT02265744|BG000|Baseline|Experimental: 12.5mg SC BMS-931699 Weekly|Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
11210509|NCT02265744|BG001|Baseline|Experimental: 12.5mg SC BMS-931699 Every Other Week|Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
11210510|NCT02265744|BG002|Baseline|Experimental: 5mg SC Injection BMS-931699 Every Other Week|Subjects received 5 mg SC injection of lulizumab pegol EOW.
11210511|NCT02265744|BG003|Baseline|Experimental: 1.25mg SCBMS-931699 Every Other Week|Subjects received 1.25 mg lulizumab pegol SC injection EOW
11210512|NCT02265744|BG004|Baseline|Placebo Comparator: 0mg SC Weekly BMS-931699|Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
11210513|NCT02265744|BG005|Baseline|Total|Total of all reporting groups
11210514|NCT02265744|FG000|Participant Flow|Experimental: 12.5mg SC BMS-931699 Weekly|Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
11210515|NCT02265744|FG001|Participant Flow|Experimental: 12.5mg SC BMS-931699 Every Other Week|Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
11210516|NCT02265744|FG002|Participant Flow|Experimental: 5mg SC Injection BMS-931699 Every Other Week|Subjects received 5 mg SC injection of lulizumab pegol EOW.
11210517|NCT02265744|FG003|Participant Flow|Experimental: 1.25mg SCBMS-931699 Every Other Week|Subjects received 1.25 mg lulizumab pegol SC injection EOW
11210518|NCT02265744|FG004|Participant Flow|Placebo Comparator: 0mg SC Weekly BMS-931699|Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
11210519|NCT02265744|OG000|Outcome|Experimental: 12.5mg SC BMS-931699 Weekly|Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
11210520|NCT02265744|OG001|Outcome|Experimental: 12.5mg SC BMS-931699 Every Other Week|Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
11210521|NCT02265744|OG002|Outcome|Experimental: 5mg SC Injection BMS-931699 Every Other Week|Subjects received 5 mg SC injection of lulizumab pegol EOW.
11210522|NCT02265744|OG003|Outcome|Experimental: 1.25mg SCBMS-931699 Every Other Week|Subjects received 1.25 mg lulizumab pegol SC injection EOW
11210523|NCT02265744|OG004|Outcome|Placebo Comparator: 0mg SC Weekly BMS-931699|Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
11210524|NCT02265744|EG000|Reported Event|Placebo - Short Term (ST)|Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
11210525|NCT02265744|EG001|Reported Event|Lulizumab Pegol 12.5 mg Weekly - ST|Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
11210526|NCT02265744|EG002|Reported Event|Lulizumab Pegol 12.5 mg EOW - ST|Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
11210527|NCT02265744|EG003|Reported Event|Lulizumab Pegol 5 mg EOW - ST|Subjects received 5 mg SC injection of lulizumab pegol EOW.
11210528|NCT02265744|EG004|Reported Event|Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST|Subjects received 1.25 mg lulizumab pegol SC injection EOW.
11210529|NCT02265783|BG000|Baseline|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
11210530|NCT02265783|FG000|Participant Flow|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
11210531|NCT02265783|OG000|Outcome|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
11210532|NCT02265783|EG000|Reported Event|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
11210533|NCT02265796|BG000|Baseline|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11210534|NCT02265796|BG001|Baseline|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
11210535|NCT02265796|BG002|Baseline|Total|Total of all reporting groups
11210536|NCT02265796|FG000|Participant Flow|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11210537|NCT02265796|FG001|Participant Flow|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
11210538|NCT02265796|OG000|Outcome|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11210539|NCT02265796|OG001|Outcome|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
11210540|NCT02265796|EG000|Reported Event|Ranolazine|"Ranolazine 500 mg tablets~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Ranolazine: Ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks"
11210541|NCT02265796|EG001|Reported Event|Sugar Pill|"Sugar pill that looks like the drug ranolazine 500mg tablet~500mg tablet two times per day for 7 days then,~500mg tablet (1000mg) two times per day for 15 weeks~Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks"
11210542|NCT02265848|BG000|Baseline|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210543|NCT02265848|BG001|Baseline|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210544|NCT02265848|BG002|Baseline|Total|Total of all reporting groups
11210545|NCT02265848|FG000|Participant Flow|Treatment Group A|"Subjects randomized to the treatment group A will begin the 7 week study per sequence (e.g., High frequency first, then Low frequency and Low frequency first, then High frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
11210546|NCT02265848|FG001|Participant Flow|Treatment Group B|"Subjects randomized to the treatment group B will begin the 7 week study per sequence (e.g., Low frequency first, then High frequency and High frequency first, then Low frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
11210547|NCT02265848|OG000|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210548|NCT02265848|OG001|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210549|NCT02265848|EG000|Reported Event|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210550|NCT02265848|EG001|Reported Event|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
11210551|NCT02265913|BG000|Baseline|Test Product|"acyclovir cream~Acyclovir 5 percent (Perrigo)"
11210552|NCT02265913|BG001|Baseline|Reference Product|"acyclovir cream~Acyclovir 5 percent (Reference)"
10819744|NCT00049543|BG000|Baseline|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
11210553|NCT02265913|BG002|Baseline|Placebo Product|"Placebo cream~Placebo cream"
11210554|NCT02265913|BG003|Baseline|Total|Total of all reporting groups
11210555|NCT02265913|FG000|Participant Flow|Test Product|"acyclovir cream~Acyclovir 5 percent (Perrigo)"
11210556|NCT02265913|FG001|Participant Flow|Reference Product|"acyclovir cream~Acyclovir 5 percent (Reference)"
11210557|NCT02265913|FG002|Participant Flow|Placebo Product|"Placebo cream~Placebo cream"
11210558|NCT02265913|OG000|Outcome|Test Product|acyclovir cream: Acyclovir 5 percent (Perrigo)
11210559|NCT02265913|OG001|Outcome|Reference Product|acyclovir cream: Acyclovir 5 percent (Zovirax)
11210560|NCT02265913|OG002|Outcome|Placebo Product|vehicle of the test product cream
11210561|NCT02265913|EG000|Reported Event|Test Product|"acyclovir cream~Acyclovir 5 percent (Perrigo)"
11210562|NCT02265913|EG001|Reported Event|Reference Product|"acyclovir cream~Acyclovir 5 percent (Reference)"
11210563|NCT02265913|EG002|Reported Event|Placebo Product|"Placebo cream~Placebo cream"
11210564|NCT02265952|BG000|Baseline|REGN1500 250 mg SC/15 mg/kg IV/450 mg SC|Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
11210565|NCT02265952|FG000|Participant Flow|REGN1500 250 mg SC/15 mg/kg IV/450 mg SC|Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
11210566|NCT02265952|FG001|Participant Flow|REGN1500 300 mg SC/20 mg/kg IV|Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
11210567|NCT02265952|OG000|Outcome|REGN1500 250 mg SC/15 mg/kg IV/450 mg SC|Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
11210568|NCT02265952|OG000|Outcome|REGN1500 300 mg SC/20 mg/kg IV|Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
11210569|NCT02265952|EG000|Reported Event|Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC|Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
11210570|NCT02265952|EG001|Reported Event|OLE Period: REGN1500 300 mg SC/20 mg/kg IV|Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
11210571|NCT02265965|BG000|Baseline|Intravenous Nitroglycerin|"Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered~intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery"
11210572|NCT02265965|BG001|Baseline|Intravenous Saline|Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
11210573|NCT02265965|BG002|Baseline|Total|Total of all reporting groups
10819745|NCT00049543|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
10819746|NCT00049543|BG002|Baseline|Total|Total of all reporting groups
10819747|NCT00049543|FG000|Participant Flow|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
10819748|NCT00049543|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11210574|NCT02265965|FG000|Participant Flow|Intravenous Nitroglycerin|"Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered~intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery"
11210575|NCT02265965|FG001|Participant Flow|Intravenous Saline|Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
11210576|NCT02265965|OG000|Outcome|Intravenous Nitroglycerin|"Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered~intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery"
11210577|NCT02265965|OG001|Outcome|Intravenous Saline|Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
11210578|NCT02265965|EG000|Reported Event|Intravenous Nitroglycerin|"Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered~intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery"
11210579|NCT02265965|EG001|Reported Event|Intravenous Saline|Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
11210580|NCT02266004|BG000|Baseline|tDCS+ LT|"Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.~Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.~locomotor training: An individualized dual-task walking program for approximately 30 minutes."
11210581|NCT02266004|FG000|Participant Flow|tDCS+ LT|"Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.~Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.~locomotor training: An individualized dual-task walking program for approximately 30 minutes."
11210582|NCT02266004|OG000|Outcome|tDCS+ LT|"Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.~Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.~locomotor training: An individualized dual-task walking program for approximately 30 minutes."
11210583|NCT02266004|EG000|Reported Event|tDCS+ LT|"Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.~Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.~locomotor training: An individualized dual-task walking program for approximately 30 minutes."
11210584|NCT02266108|BG000|Baseline|ESTIMA Intervention|"This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210585|NCT02266108|BG001|Baseline|Wait-list Control|"This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210586|NCT02266108|BG002|Baseline|Total|Total of all reporting groups
11210587|NCT02266108|FG000|Participant Flow|ESTIMA Intervention|"This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210588|NCT02266108|FG001|Participant Flow|Wait-list Control|"This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210589|NCT02266108|OG000|Outcome|ESTIMA Intervention|"This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210590|NCT02266108|OG001|Outcome|Wait-list Control|"This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210591|NCT02266108|EG000|Reported Event|ESTIMA Intervention|"This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210592|NCT02266108|EG001|Reported Event|Wait-list Control|"This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.~ESTIMA Intervention: This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico."
11210593|NCT02266147|BG000|Baseline|1 mg/mL|"PART 1~COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29"
11210594|NCT02266147|BG001|Baseline|2 mg/mL|"PART 1~COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29"
11210595|NCT02266147|BG002|Baseline|4 mg/mL|"PART 1~COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29"
11210596|NCT02266147|BG003|Baseline|8 mg/mL|"PART 1~COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29"
11210597|NCT02266147|BG004|Baseline|Total|Total of all reporting groups
11210598|NCT02266147|FG000|Participant Flow|1 mg/mL|PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
11210599|NCT02266147|FG001|Participant Flow|2 mg/mL|"PART 1~COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29"
11210600|NCT02266147|FG002|Participant Flow|4 mg/mL|"PART 1~COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29"
11210601|NCT02266147|FG003|Participant Flow|8 mg/mL|PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
11210602|NCT02266147|OG000|Outcome|1 mg/mL|"PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;~PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29"
11210603|NCT02266147|OG001|Outcome|2 mg/mL|"PART 1~COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29"
11210604|NCT02266147|OG002|Outcome|4 mg/mL|"PART 1~COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29"
11210605|NCT02266147|OG003|Outcome|8 mg/mL|"PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;~PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29"
11210606|NCT02266147|OG000|Outcome|1 mg/mL|PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
10819749|NCT00049543|OG000|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
10819750|NCT00049543|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11210607|NCT02266147|OG003|Outcome|8 mg/mL|PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
11210608|NCT02266147|EG000|Reported Event|1 mg/mL|"PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;~PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29"
11210609|NCT02266147|EG001|Reported Event|2 mg/mL|"PART 1~COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29"
11210610|NCT02266147|EG002|Reported Event|4 mg/mL|"PART 1~COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29"
11210611|NCT02266147|EG003|Reported Event|8 mg/mL|"PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;~PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29"
11210612|NCT02266225|BG000|Baseline|Lifestyle-integrated Functional Exercise|"Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.~Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session."
11210613|NCT02266225|FG000|Participant Flow|Lifestyle-integrated Functional Exercise|Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
11210614|NCT02266225|OG000|Outcome|Lifestyle-integrated Functional Exercise|Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
11210615|NCT02266225|OG000|Outcome|Lifestyle-integrated Functional Exercise|"Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.~Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session."
11210616|NCT02266225|EG000|Reported Event|Lifestyle-integrated Functional Exercise|"Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.~Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session."
11210617|NCT02266277|BG000|Baseline|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210618|NCT02266277|BG001|Baseline|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210619|NCT02266277|BG002|Baseline|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210620|NCT02266277|BG003|Baseline|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
11210621|NCT02266277|BG004|Baseline|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210622|NCT02266277|BG005|Baseline|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
11210623|NCT02266277|BG006|Baseline|Total|Total of all reporting groups
11210624|NCT02266277|FG000|Participant Flow|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with Interactive Voice Recognition (IVR) call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210625|NCT02266277|FG001|Participant Flow|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210626|NCT02266277|FG002|Participant Flow|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210627|NCT02266277|FG003|Participant Flow|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
11210628|NCT02266277|FG004|Participant Flow|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210629|NCT02266277|FG005|Participant Flow|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
11210630|NCT02266277|OG000|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210631|NCT02266277|OG001|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210632|NCT02266277|OG002|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210633|NCT02266277|OG003|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
11210634|NCT02266277|OG004|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210635|NCT02266277|OG005|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
11210636|NCT02266277|OG000|Outcome|Portal Self-Report|Patients who received portal questionnaire.
11210637|NCT02266277|OG001|Outcome|IVR Self-Report|Patients who received IVR questionnaire.
11210638|NCT02266277|EG000|Reported Event|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210639|NCT02266277|EG001|Reported Event|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210640|NCT02266277|EG002|Reported Event|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210641|NCT02266277|EG003|Reported Event|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
11210642|NCT02266277|EG004|Reported Event|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
11210643|NCT02266277|EG005|Reported Event|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
11210644|NCT02266381|BG000|Baseline|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
11210645|NCT02266381|BG001|Baseline|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
11210646|NCT02266381|BG002|Baseline|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
11210647|NCT02266381|BG003|Baseline|Total|Total of all reporting groups
11210648|NCT02266381|FG000|Participant Flow|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
11210649|NCT02266381|FG001|Participant Flow|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
11210650|NCT02266381|FG002|Participant Flow|Combined-guided Group|Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
11210651|NCT02266381|OG000|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
11210652|NCT02266381|OG001|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
11210653|NCT02266381|OG002|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
11210654|NCT02266381|OG000|Outcome|US-guided Group|Patients in US-guided undergo MPCNL using only US-guided renal access.
11210655|NCT02266381|OG002|Outcome|Combined Group|Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
11210656|NCT02266381|EG000|Reported Event|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
11210657|NCT02266381|EG001|Reported Event|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
11210658|NCT02266381|EG002|Reported Event|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
11210659|NCT02266433|BG000|Baseline|Arm Receiving Dexamethasone Injection|"Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up."
11210660|NCT02266433|BG001|Baseline|Arm Receiving Ketorolac Injection|"Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study"
11210661|NCT02266433|BG002|Baseline|Total|Total of all reporting groups
11210662|NCT02266433|FG000|Participant Flow|Arm Receiving Dexamethasone Injection|"Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study."
11210663|NCT02266433|FG001|Participant Flow|Arm Receiving Ketorolac Injection|"Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study"
11210664|NCT02266433|OG000|Outcome|Arm Receiving Dexamethasone Injection|"Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.~In its approved indication there use limitations for immunocompromised"
11210665|NCT02266433|OG001|Outcome|Arm Receiving Ketorolac Injection|"Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study"
11210666|NCT02266433|OG001|Outcome|Arm Receiving Ketorolac Injection|"Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study."
11210667|NCT02266433|EG000|Reported Event|Arm Receiving Dexamethasone Injection|"Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.~In its approved indication there use limitations for immunocompromised"
11210668|NCT02266433|EG001|Reported Event|Arm Receiving Ketorolac Injection|"Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.~Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.~Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study"
11210669|NCT02266472|BG000|Baseline|Fed 10mg+1000mg FDC/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
11210670|NCT02266472|BG001|Baseline|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
11210671|NCT02266472|BG002|Baseline|Total|Total of all reporting groups
11210672|NCT02266472|FG000|Participant Flow|Fed 10mg+1000mg Fixed Dose Combination (FDC)/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
11210673|NCT02266472|FG001|Participant Flow|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
11210674|NCT02266472|OG000|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
11210675|NCT02266472|OG001|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
11210676|NCT02266472|EG000|Reported Event|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
11210677|NCT02266472|EG001|Reported Event|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
11210678|NCT02266576|BG000|Baseline|Standard DPP|Participants receive Standard DPP over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.
11210679|NCT02266576|BG001|Baseline|Enhanced DPP|Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
11210680|NCT02266576|BG002|Baseline|Total|Total of all reporting groups
11210681|NCT02266576|FG000|Participant Flow|Standard Diabetes Prevention Program (DPP)|Participants receive Standard DPP (Group Lifestyle Balance™ DPP delivered by the San Jose State Timpany Center) over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.
11210682|NCT02266576|FG001|Participant Flow|Enhanced DPP|Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops such as the use of talking circles, a modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
11210683|NCT02266576|OG000|Outcome|Standard DPP|Participants receive Standard DPP over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.
10819751|NCT00049543|EG000|Reported Event|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
10819752|NCT00049543|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
11210684|NCT02266576|OG001|Outcome|Enhanced DPP|Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
11210685|NCT02266576|EG000|Reported Event|Standard DPP|Participants receive Standard DPP over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.
11210686|NCT02266576|EG001|Reported Event|Enhanced DPP|Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
11210687|NCT02266706|BG000|Baseline|Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC|Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1.
11210688|NCT02266706|BG001|Baseline|Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg|Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210689|NCT02266706|BG002|Baseline|Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210690|NCT02266706|BG003|Baseline|Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210691|NCT02266706|BG004|Baseline|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210692|NCT02266706|BG005|Baseline|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210693|NCT02266706|BG006|Baseline|Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210694|NCT02266706|BG007|Baseline|Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1.
11210695|NCT02266706|BG008|Baseline|Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210696|NCT02266706|BG009|Baseline|Total|Total of all reporting groups
11210697|NCT02266706|FG000|Participant Flow|Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC|Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1.
11210698|NCT02266706|FG001|Participant Flow|Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg|Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210699|NCT02266706|FG002|Participant Flow|Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210700|NCT02266706|FG003|Participant Flow|Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210701|NCT02266706|FG004|Participant Flow|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210702|NCT02266706|FG005|Participant Flow|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210703|NCT02266706|FG006|Participant Flow|Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210704|NCT02266706|FG007|Participant Flow|Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1.
11210705|NCT02266706|FG008|Participant Flow|Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210706|NCT02266706|OG000|Outcome|Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC|Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1.
11210707|NCT02266706|OG001|Outcome|Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg|Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210708|NCT02266706|OG002|Outcome|Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210709|NCT02266706|OG003|Outcome|Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210710|NCT02266706|OG004|Outcome|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210711|NCT02266706|OG005|Outcome|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210712|NCT02266706|OG006|Outcome|Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210713|NCT02266706|OG007|Outcome|Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1.
11210714|NCT02266706|OG008|Outcome|Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210715|NCT02266706|EG000|Reported Event|Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC|Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1.
11210716|NCT02266706|EG001|Reported Event|Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg|Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210717|NCT02266706|EG002|Reported Event|Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210718|NCT02266706|EG003|Reported Event|Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg|Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210719|NCT02266706|EG004|Reported Event|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
11210720|NCT02266706|EG005|Reported Event|Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg|Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1.
11210721|NCT02266706|EG006|Reported Event|Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210722|NCT02266706|EG007|Reported Event|Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1.
11210723|NCT02266706|EG008|Reported Event|Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg|Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1.
11210724|NCT02266810|BG000|Baseline|PROPEL Mini Sinus Implant and No Implant Cohort 1|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210725|NCT02266810|BG001|Baseline|PROPEL Nova Sinus Implant and No Implant Cohort 2|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210726|NCT02266810|BG002|Baseline|Total|Total of all reporting groups
11210727|NCT02266810|FG000|Participant Flow|PROPEL Mini Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery"
11210728|NCT02266810|FG001|Participant Flow|PROPEL Nova Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
11210729|NCT02266810|OG000|Outcome|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210730|NCT02266810|OG001|Outcome|Sinus Surgery Only: Cohort 1|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
11210731|NCT02266810|OG000|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~Propel Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
11210732|NCT02266810|OG001|Outcome|Sinus Surgery Only: Cohort 2|"Sinus surgery with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
11210733|NCT02266810|OG000|Outcome|PROPEL Mini Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery"
11210734|NCT02266810|OG001|Outcome|Sinus Surgery Only: Cohort 1|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~Sinus Surgery only: Sinus surgery only, without implant placement"
11210735|NCT02266810|OG001|Outcome|Sinus Surgery Alone: Cohort 1|"Sinus Surgery only: cohort 1: ESS with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
11210736|NCT02266810|OG000|Outcome|PROPEL Nova Sinus Implant|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery"
11210737|NCT02266810|OG001|Outcome|Sinus Surgery Only: Cohort 2|"This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.~Sinus Surgery only: Sinus surgery only, without implant placement"
11210738|NCT02266810|OG000|Outcome|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210739|NCT02266810|OG001|Outcome|Sinus Surgery Alone: Cohort 2|"Sinus Surgery only: cohort 2: ESS with standard post-operative care.~Sinus Surgery alone: Sinus surgery only, without implant placement"
11210740|NCT02266810|EG000|Reported Event|PROPEL Mini Sinus Implant|"Propel Mini placed in frontal sinus opening following ESS~PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210741|NCT02266810|EG001|Reported Event|PROPEL Nova Sinus Implant|"Propel Nova placed in frontal sinus opening following ESS~PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery"
11210742|NCT02266875|BG000|Baseline|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
11210743|NCT02266875|BG001|Baseline|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
11210744|NCT02266875|BG002|Baseline|Total|Total of all reporting groups
11210745|NCT02266875|FG000|Participant Flow|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
11210746|NCT02266875|FG001|Participant Flow|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
11210747|NCT02266875|OG000|Outcome|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~hypertonic saline"
11210748|NCT02266875|OG001|Outcome|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.~standard saline"
11210749|NCT02266875|EG000|Reported Event|Hypertonic Saline|"Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale."
11210750|NCT02266875|EG001|Reported Event|Standard Saline|"Patients will receive standard saline (0.9%) saline along with standard 2.5 mg albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).~Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale."
11215483|NCT02299479|BG000|Baseline|Dexcom G4 Platinum CGM and Activity Monitor|"Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data.~Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.~Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity."
11215484|NCT02299479|FG000|Participant Flow|Dexcom G4 Platinum CGM & Activity Monitor|"Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data.~Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.~Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity."
11215485|NCT02299479|OG000|Outcome|Dexcom G4 Platinum CGM & Activity Monitor|"Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data.~Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.~Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity."
11244403|NCT02510794|EG001|Reported Event|Port Delivery System With Ranibizumab 40mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11286227|NCT02885350|FG000|Participant Flow|Spinal Fentanyl|"20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
10819753|NCT00049673|BG000|Baseline|Prednisone|"Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.~prednisone: Given orally~thalidomide: Given orally"
11210751|NCT02266888|BG000|Baseline|Rituximab|Induction: Rituximab was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210752|NCT02266888|BG001|Baseline|Placebo|Induction: Rituximab placebo was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210753|NCT02266888|BG002|Baseline|Total|Total of all reporting groups
11210754|NCT02266888|FG000|Participant Flow|Rituximab|Induction: Rituximab was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210755|NCT02266888|FG001|Participant Flow|Placebo|Induction: Rituximab placebo was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210756|NCT02266888|FG002|Participant Flow|Discontinued Pre-Transplant|Participants who enrolled, but withdrew from the study prior to receiving a transplant.
11210757|NCT02266888|FG003|Participant Flow|Discontinued Pre-Randomization|Participants who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
11210758|NCT02266888|OG000|Outcome|Rituximab|Induction: Rituximab was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210759|NCT02266888|OG001|Outcome|Placebo|Induction: Rituximab placebo was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
10819754|NCT00049673|BG001|Baseline|Observation|Patients undergo observation.
11210760|NCT02266888|EG000|Reported Event|Rituximab|Induction: Rituximab was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210761|NCT02266888|EG001|Reported Event|Placebo|Induction: Rituximab placebo was administered in two 375 mg/m^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
11210762|NCT02266888|EG002|Reported Event|Discontinued Pre-Transplant|Subjects who enrolled, but withdrew from the study prior to receiving a transplant.
11210763|NCT02266888|EG003|Reported Event|Discontinued Pre-Randomization|Subjects who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
11210764|NCT02267083|BG000|Baseline|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
11210765|NCT02267083|FG000|Participant Flow|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
11210766|NCT02267083|OG000|Outcome|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
11210767|NCT02267083|EG000|Reported Event|GPX-150|"GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.~GPX-150 for Injection: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study."
11210768|NCT02267135|BG000|Baseline|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
11210769|NCT02267135|BG001|Baseline|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
11210770|NCT02267135|BG002|Baseline|Total|Total of all reporting groups
10819755|NCT00049673|BG002|Baseline|Total|Total of all reporting groups
10819756|NCT00049673|FG000|Participant Flow|Prednisone|"Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.~prednisone: Given orally~thalidomide: Given orally"
11210771|NCT02267135|FG000|Participant Flow|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
11210772|NCT02267135|FG001|Participant Flow|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
11210773|NCT02267135|OG000|Outcome|Secukinumab|Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
11210774|NCT02267135|OG001|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
11210775|NCT02267135|OG001|Outcome|Placebo|Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg
10819757|NCT00049673|FG001|Participant Flow|Observation|Patients undergo observation.
10819758|NCT00049673|OG000|Outcome|Prednisone|"Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.~prednisone: Given orally~thalidomide: Given orally"
10819759|NCT00049673|OG001|Outcome|Observation|Patients undergo observation.
10819760|NCT00049673|EG000|Reported Event|Prednisone|"Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.~prednisone: Given orally~thalidomide: Given orally"
10819761|NCT00049673|EG001|Reported Event|Observation|Patients undergo observation.
10819762|NCT00049842|BG000|Baseline|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
11210776|NCT02267135|EG000|Reported Event|Treatment Period 1 Secukinumab 300 mg|Treatment Period 1 Secukinumab 300 mg
11210777|NCT02267135|EG001|Reported Event|Treatment Period 1 Placebo|Treatment Period 1 Placebo
11210778|NCT02267135|EG002|Reported Event|Treatment Period 2 Placebo/Secukinumab 300 mg|Treatment Period 2 Placebo/Secukinumab 300 mg
11210779|NCT02267135|EG003|Reported Event|Treatment Period 1 & 2: Any Secukinumab|
11210780|NCT02267187|BG000|Baseline|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
11286228|NCT02885350|FG001|Participant Flow|Epidural Fentanyl|"100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
10819763|NCT00049842|BG001|Baseline|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
10819764|NCT00049842|BG002|Baseline|Total|Total of all reporting groups
10819765|NCT00049842|FG000|Participant Flow|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
10819766|NCT00049842|FG001|Participant Flow|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
10819767|NCT00049842|OG000|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
10819768|NCT00049842|OG001|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
10819769|NCT00049842|EG000|Reported Event|PEG-Intron|
10819770|NCT00049842|EG001|Reported Event|Untreated Control|
10819771|NCT00050011|BG000|Baseline|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
10819772|NCT00050011|BG001|Baseline|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
10819773|NCT00050011|BG002|Baseline|Total|Total of all reporting groups
10819774|NCT00050011|FG000|Participant Flow|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
10819775|NCT00050011|FG001|Participant Flow|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
10819776|NCT00050011|OG000|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
10819777|NCT00050011|OG001|Outcome|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
10819778|NCT00050011|OG001|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
10819779|NCT00050011|EG000|Reported Event|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Femara 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
10819780|NCT00050011|EG001|Reported Event|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
10819781|NCT00050089|BG000|Baseline|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
11210781|NCT02267187|FG000|Participant Flow|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
11210782|NCT02267187|OG000|Outcome|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
11210783|NCT02267187|EG000|Reported Event|Cotton Rolling Fat Grafting|"For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.~The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component."
10819782|NCT00050089|BG001|Baseline|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
10819783|NCT00050089|BG002|Baseline|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
10819784|NCT00050089|BG003|Baseline|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
10819785|NCT00050089|BG004|Baseline|Total|Total of all reporting groups
10819786|NCT00050089|FG000|Participant Flow|No ARDFP+Standard-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART~Standard-ART: up to 4 anti-HIV drugs"
10819787|NCT00050089|FG001|Participant Flow|No ARDFP+Mega-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART~Mega-ART: 5 or more anti-HIV drugs"
10819788|NCT00050089|FG002|Participant Flow|ARDFP+Standard-ART|"Antiretroviral Drug-Free Period (ARDFP) and Standard-ART~Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs"
10819789|NCT00050089|FG003|Participant Flow|ARDFP+Mega-ART|"Antiretroviral Drug-Free Period (ARDFP) and Mega-ART~Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs"
11210784|NCT02267226|BG000|Baseline|SAFETY Population|All patients who received at least one Octafibrin administration during the study.
11210785|NCT02267226|FG000|Participant Flow|Octafibrin|"Thirty-three patients were screened and 25 patients received at least one administration of Octafibrin for treatment of bleeding or as surgical prophylaxis. Eight patients received Octafibrin for both bleeding and a surgical procedure. One patient was treated for a surgical procedure only.~Octafibrin was individually dosed to achieve a recommended target plasma fibrinogen level of 100 mg/dL for minor bleeds/surgery or 150 mg/dL for major bleeds/surgery"
11210786|NCT02267226|OG000|Outcome|Investigator Assessment|Efficacy as assessed by the investigator
11210787|NCT02267226|OG001|Outcome|IDMEAC Assessment|Efficacy as assessed by the IDMEAC
11210788|NCT02267226|OG000|Outcome|FAS Bleeding|FAS-Bleeding population (change from pre fibrinogen infusion)
11210789|NCT02267226|OG000|Outcome|Pre-infusion|FAS-Bleeding population pre-infusion.
11210790|NCT02267226|OG001|Outcome|Day 1 Post-infusion 1 h|FAS-Bleeding population, day 1 post-infusion 1h
11210791|NCT02267226|OG002|Outcome|Day 1 Post-infusion 3 h|FAS-Bleeding population, day 1 post-infusion 3h
11210792|NCT02267226|OG003|Outcome|1 Day After Last Infusion|FAS-Bleeding population 1 day after last infusion
11210793|NCT02267226|OG000|Outcome|FAS-Bleeding|FAS-Bleeding population
11210794|NCT02267226|OG000|Outcome|Investigator|FAS-Bleeding population (all bleeding episodes) as assessed by the investigator
11210795|NCT02267226|OG001|Outcome|IDMEAC|FAS-Bleeding population (all bleeding episodes) as assessed by the IDMEAC
11210796|NCT02267226|OG000|Outcome|Surgeon (Intra-op)|Octafibrin efficacy assessed by the surgeon during the operation.
11210797|NCT02267226|OG001|Outcome|IDMEAC (Intra-op)|Octafibrin efficacy assessed by IDMEAC during the operation.
11210798|NCT02267226|OG002|Outcome|Haematologist (Post-op)|Octafibrin efficacy assessed by the Haematologist after the operation.
11210799|NCT02267226|OG003|Outcome|IDMEAC (Post-op)|Octafibrin efficacy assessed by IDMEAC after the operation.
11210800|NCT02267226|OG000|Outcome|Pre-infusion|FAS-Bleeding population, immunogenicity testing prior to infusion.
11210801|NCT02267226|OG001|Outcome|Observational Period|FAS-Bleeding population, immunogenicity testing during the observational period.*
11210802|NCT02267226|EG000|Reported Event|Safety Population|All patients who received at least one administration of Octafibrin during the study
11210803|NCT02267278|BG000|Baseline|Ruxolitinib + Pracinostat|"Ruxolitinib starting dose 15 mg orally twice/day in 28-day cycle (dose assigned based on platelet count, if low platelet count gradual up-titration from a starting dose of 5 mg) - given alone for first 3 months, then Pracinostat added at starting dose 60 mg orally once/day for 3 alternating days every 3 weeks starting Day 1 of Cycle 4.~Dose of Ruxolitinib may be increased or decreased prior to initiation of Pracinostat. Quality of Life Questionnaire."
11210804|NCT02267278|FG000|Participant Flow|Ruxolitinib + Pracinostat|"Ruxolitinib starting dose 15 mg orally twice/day in 28-day cycle (dose assigned based on platelet count, if low platelet count gradual up-titration from a starting dose of 5 mg) - given alone for first 3 months, then Pracinostat added at starting dose 60 mg orally once/day for 3 alternating days every 3 weeks starting Day 1 of Cycle 4.~Dose of Ruxolitinib may be increased or decreased prior to initiation of Pracinostat. Quality of Life Questionnaire."
11210805|NCT02267278|OG000|Outcome|Ruxolitinib + Pracinostat|"Ruxolitinib starting dose 15 mg orally twice/day in 28-day cycle (dose assigned based on platelet count, if low platelet count gradual up-titration from a starting dose of 5 mg) - given alone for first 3 months, then Pracinostat added at starting dose 60 mg orally once/day for 3 alternating days every 3 weeks starting Day 1 of Cycle 4.~Dose of Ruxolitinib may be increased or decreased prior to initiation of Pracinostat. Quality of Life Questionnaire."
11210806|NCT02267278|EG000|Reported Event|Ruxolitinib + Pracinostat|"Ruxolitinib starting dose 15 mg orally twice/day in 28-day cycle (dose assigned based on platelet count, if low platelet count gradual up-titration from a starting dose of 5 mg) - given alone for first 3 months, then Pracinostat added at starting dose 60 mg orally once/day for 3 alternating days every 3 weeks starting Day 1 of Cycle 4.~Dose of Ruxolitinib may be increased or decreased prior to initiation of Pracinostat. Quality of Life Questionnaire."
11210807|NCT02267317|BG000|Baseline|Obese Group|Subjects with BMI >30 kg/m2 were enrolled to receive two infusions, the order of which was randomly assigned.
11210808|NCT02267317|BG001|Baseline|Type 2 Diabetic Subjects|Subjects with BMI >30 kg/m2 and 2-hour Oral Glucose Tolerance Test >200mg/dL
11210809|NCT02267317|BG002|Baseline|Lean/Healthy|Subjects with BMI <26 kg/m2 and normal glucose tolerant
11210810|NCT02267317|BG003|Baseline|Total|Total of all reporting groups
11210811|NCT02267317|FG000|Participant Flow|Obese Group - D5W - Eritoran|Obese subjects randomized to receive D5W first, then Eritoran
11210812|NCT02267317|FG001|Participant Flow|Obese Group - Eritoran - D5W|Obese subjects randomized to receive Eritoran first, then D5W.
11210813|NCT02267317|FG002|Participant Flow|Diabetes (T2DM) Group - D5W - Eritoran|T2DM subjects randomized to receive D5W first then Eritoran
11210814|NCT02267317|FG003|Participant Flow|Diabetes (T2DM) Group - Eritoran - D5W|T2DM subjects randomized to receive Eritoran first then D5W
11210815|NCT02267317|FG004|Participant Flow|Lean Group - D5W - Eritoran|Lean subjects randomized to receive D5W first then Eritoran
11210816|NCT02267317|FG005|Participant Flow|Lean Group - Eritoran - D5W|Lean subjects randomized to receive Eritoran first then d5W
11210817|NCT02267317|OG000|Outcome|Obese Group - Placebo|Obese subjects - IV administration of D5W (5% Dextrose in water)
11210818|NCT02267317|OG001|Outcome|Obese Group - Eritoran|Obese subjects - IV administration of Eritoran 12 mg every 12 hours
11210819|NCT02267317|OG002|Outcome|Diabetes (T2DM) Group - Placebo|T2DM subjects - IV administration of D5W (5% Dextrose in water)
11210820|NCT02267317|OG003|Outcome|Diabetes (T2DM) Group - Eritoran|T2DM subjects - IV administration of Eritoran 12 mg every 12 hours
11210821|NCT02267317|OG004|Outcome|Lean - Placebo|Lean subjects - IV administration of D5W (5% Dextrose in water)
11210822|NCT02267317|OG005|Outcome|Lean - Eritoran|Lean subjects - IV administration of Eritoran 12 mg every 12 hours
11210823|NCT02267317|EG000|Reported Event|Obese Group - Placebo|Obese subjects - IV administration of D5W (5% Dextrose in water)
11210824|NCT02267317|EG001|Reported Event|Obese Group - Eritoran|Obese subjects - IV administration of Eritoran 12 mg every 12 hours
11210825|NCT02267317|EG002|Reported Event|Diabetes (T2DM) Group - Placebo|T2DM subjects - IV administration of D5W (5% Dextrose in water)
11210826|NCT02267317|EG003|Reported Event|Diabetes (T2DM) Group - Eritoran|T2DM subjects - IV administration of Eritoran 12 mg every 12 hours
11210827|NCT02267317|EG004|Reported Event|Lean/Healthy Group - Placebo|Lean subjects - IV administration of D5W (5% Dextrose in water)
11210828|NCT02267317|EG005|Reported Event|Lean/Healthy Group - Eritoran|Lean subjects - IV administration of Eritoran 12 mg every 12 hours
11210829|NCT02267356|BG000|Baseline|Low Dose 12-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
11210830|NCT02267356|BG001|Baseline|Low Dose 24-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210831|NCT02267356|BG002|Baseline|High Dose 12-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
11210832|NCT02267356|BG003|Baseline|High Dose 24-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
11210833|NCT02267356|BG004|Baseline|Placebo|4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210834|NCT02267356|BG005|Baseline|Total|Total of all reporting groups
11210835|NCT02267356|FG000|Participant Flow|Low Dose 12-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
11210836|NCT02267356|FG001|Participant Flow|Low Dose 24-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210837|NCT02267356|FG002|Participant Flow|High Dose 12-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
11210838|NCT02267356|FG003|Participant Flow|High Dose 24-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
11210839|NCT02267356|FG004|Participant Flow|Placebo|4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210840|NCT02267356|OG000|Outcome|Low Dose 12-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
10819790|NCT00050089|OG000|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
10819791|NCT00050089|OG001|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
10819792|NCT00050089|OG000|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
10819793|NCT00050089|OG001|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
10819794|NCT00050089|OG000|Outcome|No ARDFP + Standard ART|Standard ART regimen, with no prior ART interruption
11210841|NCT02267356|OG001|Outcome|Low Dose 24-week|2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210842|NCT02267356|OG002|Outcome|High Dose 12-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
11210843|NCT02267356|OG003|Outcome|High Dose 24-week|4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
11210844|NCT02267356|OG004|Outcome|Placebo|4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
11210845|NCT02267356|EG000|Reported Event|Low Dose 12-week|Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks
11210846|NCT02267356|EG001|Reported Event|Low Dose 24-week|Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks
11210847|NCT02267356|EG002|Reported Event|High Dose 12-week|Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks
11210848|NCT02267356|EG003|Reported Event|High Dose 24-week|Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks
11210849|NCT02267356|EG004|Reported Event|Placebo|Matching placebo tablets for 24 weeks
11210850|NCT02267382|BG000|Baseline|VT-1161 Low-dose 3-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210851|NCT02267382|BG001|Baseline|VT-1161 Low-dose 6-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
11210852|NCT02267382|BG002|Baseline|VT-1161 High-dose 3-month|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210853|NCT02267382|BG003|Baseline|VT-1161 High-dose 24-week|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
11210854|NCT02267382|BG004|Baseline|Placebo|2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
11210855|NCT02267382|BG005|Baseline|Total|Total of all reporting groups
11210856|NCT02267382|FG000|Participant Flow|VT-1161 Low-dose 3-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210857|NCT02267382|FG001|Participant Flow|VT-1161 Low-dose 6-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
11210858|NCT02267382|FG002|Participant Flow|VT-1161 High-dose 3-month|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210859|NCT02267382|FG003|Participant Flow|VT-1161 High-dose 24-week|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
11210860|NCT02267382|FG004|Participant Flow|Placebo|2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
11210861|NCT02267382|OG000|Outcome|VT-1161 Low-dose 3-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210862|NCT02267382|OG001|Outcome|VT-1161 Low-dose 6-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
11210863|NCT02267382|OG002|Outcome|VT-1161 High-dose 3-month|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
10819795|NCT00050089|OG001|Outcome|No ARDFP + Mega ART|Intensive ART regimen, with no prior ART interruption
11210864|NCT02267382|OG003|Outcome|VT-1161 High-dose 24-week|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
11210865|NCT02267382|OG004|Outcome|Placebo|2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
11210866|NCT02267382|EG000|Reported Event|VT-1161 Low-dose 3-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210867|NCT02267382|EG001|Reported Event|VT-1161 Low-dose 6-month|1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
11210868|NCT02267382|EG002|Reported Event|VT-1161 High-dose 3-month|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
11210869|NCT02267382|EG003|Reported Event|VT-1161 High-dose 24-week|2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
11210870|NCT02267382|EG004|Reported Event|Placebo|2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
11210871|NCT02267447|BG000|Baseline|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
11210872|NCT02267447|BG001|Baseline|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Survey.
11210873|NCT02267447|BG002|Baseline|Total|Total of all reporting groups
11210874|NCT02267447|FG000|Participant Flow|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
11210875|NCT02267447|FG001|Participant Flow|Validation Cohort|Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.
11210876|NCT02267447|OG000|Outcome|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
11210877|NCT02267447|OG001|Outcome|Validation Cohort|Eligible respondents to the 2007 /2008 Canadian Community Health Surveys.
11210878|NCT02267447|OG001|Outcome|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
11210879|NCT02267447|EG000|Reported Event|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
11210880|NCT02267447|EG001|Reported Event|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
11210881|NCT02267538|BG000|Baseline|DEX Group|participant who received dexmedetomidine
11210882|NCT02267538|BG001|Baseline|CTRL Group|participants who recieved normal saline
11210883|NCT02267538|BG002|Baseline|Total|Total of all reporting groups
11210884|NCT02267538|FG000|Participant Flow|DEX Group|participant who received dexmedetomidine
10819796|NCT00050089|OG002|Outcome|ARDFP + Standard ART|Standard ART regimen following ART interruption
10819797|NCT00050089|OG003|Outcome|ARDFP + Mega ART|Intensive ART following ART interruption
10819798|NCT00050089|EG000|Reported Event|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
11210885|NCT02267538|FG001|Participant Flow|CTRL Group|participants who recieved normal saline
11210886|NCT02267538|OG000|Outcome|DEX Group|participant who received dexmedetomidine
11210887|NCT02267538|OG001|Outcome|CTRL Group|participants who recieved normal saline
11210888|NCT02267538|EG000|Reported Event|DEX Group|participant who received dexmedetomidine
11210889|NCT02267538|EG001|Reported Event|CTRL Group|participants who recieved normal saline
11210890|NCT02267577|BG000|Baseline|Adults Volunteers|"Men and women over the age of 18~Sphygmo: Automatic Blood Pressure Monitor: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals."
11210891|NCT02267577|FG000|Participant Flow|Healthy Adult Volunteers|Men and women over the age of 18 who will have their blood pressure measured using both the experimental blood pressure monitor (Sphygmo), and the gold-standard, commercial blood pressure monitor (GE Dinamap ProCare).
11210892|NCT02267577|OG000|Outcome|Healthy Adult Volunteers|Men and women over the age of 18 who had their blood pressure measured using both the experimental device (Sphygmo) as well as the commercial, gold-standard monitor (GE Dinamap ProCare).
11210893|NCT02267577|OG000|Outcome|Adults Volunteers|Men and women over the age of 18 who will have their blood pressure measured using both the experimental blood pressure monitor (Sphygmo), and the gold-standard, commercial blood pressure monitor (GE Dinamap ProCare).
11210894|NCT02267577|EG000|Reported Event|Adults Volunteers|"Men and women over the age of 18~Sphygmo: Automatic Blood Pressure Monitor: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals."
11210895|NCT02267629|BG000|Baseline|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
11210896|NCT02267629|FG000|Participant Flow|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
11210897|NCT02267629|OG000|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
11210898|NCT02267629|EG000|Reported Event|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
11210899|NCT02267746|BG000|Baseline|Test|Tazarotene 0.1% foam (Actavis LLC)
11210900|NCT02267746|BG001|Baseline|Reference|Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
11210901|NCT02267746|BG002|Baseline|Vehicle|Vehicle foam of the test product (Actavis LLC)
11210902|NCT02267746|BG003|Baseline|Total|Total of all reporting groups
11210903|NCT02267746|FG000|Participant Flow|Test|Tazarotene 0.1% foam (Actavis LLC)
11210904|NCT02267746|FG001|Participant Flow|Reference|Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
10819799|NCT00050089|EG001|Reported Event|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
10819800|NCT00050089|EG002|Reported Event|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
10819801|NCT00050089|EG003|Reported Event|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
10819802|NCT00050167|BG000|Baseline|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
10819803|NCT00050167|BG001|Baseline|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
10819804|NCT00050167|BG002|Baseline|Total|Total of all reporting groups
10819805|NCT00050167|FG000|Participant Flow|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
10819806|NCT00050167|FG001|Participant Flow|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
10819807|NCT00050167|OG000|Outcome|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
10819808|NCT00050167|OG001|Outcome|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
11210905|NCT02267746|FG002|Participant Flow|Vehicle|Vehicle foam of the test product (Actavis LLC)
10819809|NCT00050167|EG000|Reported Event|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
10819810|NCT00050167|EG001|Reported Event|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
10819811|NCT00050622|BG000|Baseline|Within-Subject Treatment|All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
10819812|NCT00050622|FG000|Participant Flow|Within-Subject Treatment|All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
10819813|NCT00050622|OG000|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
10819814|NCT00050622|OG001|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
10819815|NCT00050622|OG002|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
10819816|NCT00050622|OG003|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
10819817|NCT00050622|OG004|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
10819818|NCT00050622|OG005|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
10819819|NCT00050622|OG006|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
10819820|NCT00050622|OG007|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
10819821|NCT00050622|OG008|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
10819822|NCT00050622|OG009|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
10819823|NCT00050622|OG010|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
10819824|NCT00050622|OG011|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
10819825|NCT00050622|OG000|Outcome|No Treatment|No BMOD, No medication
10819826|NCT00050622|OG001|Outcome|Low Intensity BMOD Only|
10819827|NCT00050622|OG002|Outcome|High Intensity BMOD ONly|
10819828|NCT00050622|OG003|Outcome|Medication Only|No BMOD + Medication (any dose)
10819829|NCT00050622|OG004|Outcome|Low Intensity BMOD + Med|Low intensity behavior modification + medication (any dose)
10819830|NCT00050622|OG005|Outcome|High Intensity BMOD + Medication|High Intensity BMOD + Medication (any dose)
10819831|NCT00050622|EG000|Reported Event|Placebo|Placebo
10819832|NCT00050622|EG001|Reported Event|Low Dose Medication|0.15 mg/kg MPH, No BMOD
10819833|NCT00050622|EG002|Reported Event|Medium Dose Medication|0.3 mg/kg MPH, No BMOD
10819834|NCT00050622|EG003|Reported Event|Higher Dose Medication|0.6 mg/kg MPH, No BMOD
10819835|NCT00050778|BG000|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
10819836|NCT00050778|BG001|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
11210906|NCT02267746|OG000|Outcome|Test|Tazarotene 0.1% foam (Actavis LLC)
11210907|NCT02267746|OG001|Outcome|Reference|Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
11210908|NCT02267746|OG002|Outcome|Vehicle|Placebo foam (Actavis LLC)
11210909|NCT02267746|OG002|Outcome|Vehicle Foam|Placebo Foam (Actavis LLC)
11210910|NCT02267746|OG002|Outcome|Vehicle|Vehicle foam of the test product (Actavis LLC)
11210911|NCT02267746|EG000|Reported Event|Test|Tazarotene 0.1% foam (Actavis LLC)
11210912|NCT02267746|EG001|Reported Event|Reference|Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
11210913|NCT02267746|EG002|Reported Event|Vehicle|Vehicle foam of the test product (Actavis LLC)
11210914|NCT02267772|BG000|Baseline|IV Acetaminophen|"IV acetaminophen for pain control~IV Acetaminophen: IV Acetaminophen"
11210915|NCT02267772|BG001|Baseline|IV Morphine|"IV morphine for pain control~IV Morphine: IV Morphine"
11210916|NCT02267772|BG002|Baseline|Total|Total of all reporting groups
11210917|NCT02267772|FG000|Participant Flow|IV Acetaminophen|"IV acetaminophen for pain control~IV Acetaminophen: IV Acetaminophen"
11210918|NCT02267772|FG001|Participant Flow|IV Morphine|"IV morphine for pain control~IV Morphine: IV Morphine"
11210919|NCT02267772|OG000|Outcome|IV Acetaminophen|"IV acetaminophen for pain control~IV Acetaminophen: IV Acetaminophen"
11210920|NCT02267772|OG001|Outcome|IV Morphine|"IV morphine for pain control~IV Morphine: IV Morphine"
11210921|NCT02267772|EG000|Reported Event|IV Acetaminophen|"IV acetaminophen for pain control~IV Acetaminophen: IV Acetaminophen"
11210922|NCT02267772|EG001|Reported Event|IV Morphine|"IV morphine for pain control~IV Morphine: IV Morphine"
11210923|NCT02267811|BG000|Baseline|BX8RN: OrthoPulse™ (Treatment)|"Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210924|NCT02267811|BG001|Baseline|BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control)|"Subjects assigned to this group receive orthodontic treatment with no daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210925|NCT02267811|BG002|Baseline|Total|Total of all reporting groups
10819837|NCT00050778|BG002|Baseline|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
11210926|NCT02267811|FG000|Participant Flow|BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)|"Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210927|NCT02267811|FG001|Participant Flow|BX8RN: Orthodontic Treatment (Control)|"Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210928|NCT02267811|OG000|Outcome|BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)|"Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210929|NCT02267811|OG001|Outcome|BX8RN: Orthodontic Treatment (Control)|"Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210930|NCT02267811|OG000|Outcome|Fixed Orthodontic Treatment With OrthoPulse™ (Treatment)|"Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210931|NCT02267811|OG001|Outcome|Fixed Orthodontic Treatment (Control)|"Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210932|NCT02267811|EG000|Reported Event|Fixed Orthodontic Treatment With OrthoPulse™ (Treatment)|"Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210933|NCT02267811|EG001|Reported Event|Fixed Orthodontic Treatment (Control)|"Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.~Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210934|NCT02267824|BG000|Baseline|Extra-Oral OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home."
11210935|NCT02267824|BG001|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
11210936|NCT02267824|BG002|Baseline|Total|Total of all reporting groups
11210937|NCT02267824|FG000|Participant Flow|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
10819838|NCT00050778|BG003|Baseline|Total|Total of all reporting groups
11244404|NCT02510794|EG002|Reported Event|Port Delivery System With Ranibizumab 100mg/mL|Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
11244405|NCT02510794|EG003|Reported Event|Intravitreal Injection With Ranibizumab 0.5mg|Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
11244406|NCT02510820|BG000|Baseline|Overall Baseline Characteristics|Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
11244407|NCT02510820|FG000|Participant Flow|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
11244408|NCT02510820|FG001|Participant Flow|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
11244409|NCT02510820|OG000|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
11244410|NCT02510820|OG001|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
11244411|NCT02510820|OG000|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens Synergi: Multipurpose solution"
11244412|NCT02510820|EG000|Reported Event|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution~Biotrue: Multipurpose solution"
11244413|NCT02510820|EG001|Reported Event|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution~Synergi: Multipurpose solution"
11244414|NCT02511184|BG000|Baseline|Crizotinib + Pembrolizumab|Participants were administered combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244415|NCT02511184|BG001|Baseline|Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab|Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244416|NCT02511184|BG002|Baseline|Total|Total of all reporting groups
11244417|NCT02511184|FG000|Participant Flow|Crizotinib + Pembrolizumab|Participants were administered combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244418|NCT02511184|FG001|Participant Flow|Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab|Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244419|NCT02511184|OG000|Outcome|Crizotinib + Pembrolizumab|Participants were administered combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244420|NCT02511184|OG001|Outcome|Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab|Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244421|NCT02511184|OG000|Outcome|Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab|Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244422|NCT02511184|EG000|Reported Event|Crizotinib + Pembrolizumab|Participants were administered combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11244423|NCT02511184|EG001|Reported Event|Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab|Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first.
11286229|NCT02885350|FG002|Participant Flow|Spinal Sufentanil|"5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
11210938|NCT02267824|FG001|Participant Flow|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
11210939|NCT02267824|OG000|Outcome|Extraoral OrthoPulse® PBM and Orthodontic Treatment|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
11210940|NCT02267824|OG001|Outcome|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
11210941|NCT02267824|EG000|Reported Event|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
11210942|NCT02267824|EG001|Reported Event|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
11210943|NCT02267837|BG000|Baseline|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210944|NCT02267837|BG001|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
11210945|NCT02267837|BG002|Baseline|Total|Total of all reporting groups
11210946|NCT02267837|FG000|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210947|NCT02267837|FG001|Participant Flow|No OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210948|NCT02267837|OG000|Outcome|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210949|NCT02267837|OG001|Outcome|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210950|NCT02267837|EG000|Reported Event|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210951|NCT02267837|EG001|Reported Event|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
11210952|NCT02267850|BG000|Baseline|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210953|NCT02267850|BG001|Baseline|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
11210954|NCT02267850|BG002|Baseline|Total|Total of all reporting groups
11286230|NCT02885350|FG003|Participant Flow|Epidural Sufentanil|"20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
10819839|NCT00050778|FG000|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 micrograms (mcg) subcutaneously 3-times weekly for 36 months.
10819840|NCT00050778|FG001|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
11210955|NCT02267850|FG000|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210956|NCT02267850|FG001|Participant Flow|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
11210957|NCT02267850|OG000|Outcome|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210958|NCT02267850|OG001|Outcome|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
11210959|NCT02267850|EG000|Reported Event|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
11210960|NCT02267850|EG001|Reported Event|Sham-Control OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).~Fixed Orthodontic Appliance Treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy."
11210961|NCT02268045|BG000|Baseline|RTXM83-CHOP|Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy
11210962|NCT02268045|BG001|Baseline|MabThera-CHOP|Patients treated with Rituximab in combination with CHOP chemotherapy
11210963|NCT02268045|BG002|Baseline|Total|Total of all reporting groups
11210964|NCT02268045|FG000|Participant Flow|RTXM83|Rituximab biosimilar (RTXM83) was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.
11210965|NCT02268045|FG001|Participant Flow|MabThera|MabThera was administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles. Administration of 2 additional cycles was allowed as per Investigator's criteria.
11210966|NCT02268045|OG000|Outcome|RTXM83-CHOP|Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy
11210967|NCT02268045|OG001|Outcome|MabThera-CHOP|Patients treated with Rituximab in combination with CHOP chemotherapy
11210968|NCT02268045|OG000|Outcome|RTXM83-CHOP|Patients treated with Rituximab biosimilar with CHOP chemotherapy
11210969|NCT02268045|OG001|Outcome|MabThera- CHOP|Patients treated with Rituximab in combination with CHOP chemotherapy
11210970|NCT02268045|EG000|Reported Event|RTXM83-CHOP|Patients treated with Rituximab biosimilar in combination with CHOP chemotherapy
11210971|NCT02268045|EG001|Reported Event|MabThera-CHOP|Patients treated with Rituximab in combination with CHOP chemotherapy
11210972|NCT02268058|BG000|Baseline|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
11210973|NCT02268058|BG001|Baseline|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
11210974|NCT02268058|BG002|Baseline|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
11210975|NCT02268058|BG003|Baseline|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
11210976|NCT02268058|BG004|Baseline|Total|Total of all reporting groups
11210977|NCT02268058|FG000|Participant Flow|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
11210978|NCT02268058|FG001|Participant Flow|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
11210979|NCT02268058|FG002|Participant Flow|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
11210980|NCT02268058|FG003|Participant Flow|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
11210981|NCT02268058|OG000|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
11210982|NCT02268058|OG001|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
11210983|NCT02268058|OG002|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
11210984|NCT02268058|OG003|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
11210985|NCT02268058|EG000|Reported Event|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
11210986|NCT02268058|EG001|Reported Event|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
11210987|NCT02268058|EG002|Reported Event|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
11210988|NCT02268058|EG003|Reported Event|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
11210989|NCT02268084|BG000|Baseline|Active|Magnetic EEG/ECG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open-label treatment).
11210990|NCT02268084|BG001|Baseline|Sham|Shame treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment.
11210991|NCT02268084|BG002|Baseline|Total|Total of all reporting groups
11210992|NCT02268084|FG000|Participant Flow|Active|Magnetic EEG/ECG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open-label treatment).
10819841|NCT00050778|FG002|Participant Flow|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
11210993|NCT02268084|FG001|Participant Flow|Sham|Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active treatment devices were used for the additional 2 weeks of open-label treatment.
11210994|NCT02268084|OG000|Outcome|Active|Magnetic EEG-Guided Resonance Therapy Treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double blind treatment, two weeks of open-label treatment.
11210995|NCT02268084|OG001|Outcome|Sham|Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment.
11286231|NCT02885350|OG000|Outcome|Spinal Fentanyl|"20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
10819842|NCT00050778|OG000|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
10819843|NCT00050778|OG001|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
10819844|NCT00050778|OG002|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
10819845|NCT00050778|OG003|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
10819846|NCT00050778|EG000|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
10819847|NCT00050778|EG001|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
10819848|NCT00050778|EG002|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
11210996|NCT02268084|OG000|Outcome|Active|"Magnetic EEG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks.~Active group received two weeks of active treatment in the double-blind phase, and two weeks in the open-label treatment."
11210997|NCT02268084|OG001|Outcome|Sham|"Sham treatment devices simulate the behavior of the active devices by mimicking the noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks.~Sham group received two weeks of sham treatment in the double-blind phase, and two weeks of active treatment in the double-blind phase."
11210998|NCT02268084|OG000|Outcome|Active|Magnetic EEG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open-label treatment).
11210999|NCT02268084|OG001|Outcome|Sham|Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute fro 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment.
11211000|NCT02268084|OG000|Outcome|Active|Magnetic EEG-Guided Resonance Therapy treatments use a coil to deliver pulsed magnetic fields to the cortex of the brain. Active treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for four weeks (two weeks of double-blind treatment, two weeks of open label treatment).
11211001|NCT02268084|OG001|Outcome|Sham|Sham treatment devices simulate the behavior of the active devices by mimicking the same noise and sensation of the active treatment without applying the magnetic field. Sham treatments are administered for 6 seconds/minute for 30 minutes/day, 5 days/week for two weeks. Active devices were used for the additional two weeks of open-label treatment.
11211002|NCT02268084|EG000|Reported Event|Sham|"Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase only). Sham treatment mimicks same noise and sensation of active treatment.~Sham: Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field"
11211003|NCT02268084|EG001|Reported Event|Active|"Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 2 weeks (double blind phase) and 2 additional weeks for all subjects (open label).~Magnetic EEG/ECG-guided Resonance Therapy: A coil delivers a pulsed magnetic field to the cortex of the brain"
11211004|NCT02268214|BG000|Baseline|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily + background insulin
11211005|NCT02268214|BG001|Baseline|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily + background insulin
11211006|NCT02268214|BG002|Baseline|Placebo + Insulin|Placebo oral tablet once daily + background insulin
11211007|NCT02268214|BG003|Baseline|Total|Total of all reporting groups
11211008|NCT02268214|FG000|Participant Flow|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily + background insulin
11211009|NCT02268214|FG001|Participant Flow|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily + background insulin
11211010|NCT02268214|FG002|Participant Flow|Placebo + Insulin|Placebo oral tablet once daily + background insulin
11211011|NCT02268214|OG000|Outcome|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily + background insulin
11211012|NCT02268214|OG001|Outcome|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily + background insulin
11211013|NCT02268214|OG002|Outcome|Placebo + Insulin|Placebo oral tablet once daily + background insulin
11211014|NCT02268214|EG000|Reported Event|Dapagliflozin 5 mg + Insulin|Dapagliflozin 5 mg oral tablet once daily + background insulin
11211015|NCT02268214|EG001|Reported Event|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg oral tablet once daily + background insulin
11211016|NCT02268214|EG002|Reported Event|Placebo + Insulin|Placebo oral tablet once daily + background insulin
11211017|NCT02268396|BG000|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
11211018|NCT02268396|FG000|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
11211019|NCT02268396|OG000|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
11211020|NCT02268396|EG000|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
11211021|NCT02268500|BG000|Baseline|Standard Dose Influenza Vaccine|"Standard dose (45ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211022|NCT02268500|BG001|Baseline|High Dose Influenza Vaccine|"High dose (180ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211023|NCT02268500|BG002|Baseline|Total|Total of all reporting groups
11211024|NCT02268500|FG000|Participant Flow|Standard Dose Influenza Vaccine|"Standard dose (45ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211025|NCT02268500|FG001|Participant Flow|High Dose Influenza Vaccine|"High dose (180ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211026|NCT02268500|OG000|Outcome|Standard Dose Influenza Vaccine|"Standard dose (45ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211027|NCT02268500|OG001|Outcome|High Dose Influenza Vaccine|"High dose (180ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211028|NCT02268500|EG000|Reported Event|Standard Dose Influenza Vaccine|"Standard dose (45ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211029|NCT02268500|EG001|Reported Event|High Dose Influenza Vaccine|"High dose (180ug) influenza vaccine will be administered intramuscularly~Influenza vaccine: Influenza vaccine"
11211030|NCT02268526|BG000|Baseline|Cohort 1: CSJ148|Cohort 1: CSJ148 IV q 4weeks
11211031|NCT02268526|BG001|Baseline|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
11211032|NCT02268526|BG002|Baseline|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
11211033|NCT02268526|BG003|Baseline|Total|Total of all reporting groups
11211034|NCT02268526|FG000|Participant Flow|Cohort 1: CSJ148|Cohort 1: CSJ148 IV q 4weeks
11211035|NCT02268526|FG001|Participant Flow|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
11211036|NCT02268526|FG002|Participant Flow|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
10819849|NCT00050778|EG003|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
11211037|NCT02268526|OG000|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks and Cohort 2: CSJ148 IV q 4weeks
11211038|NCT02268526|OG001|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
11211039|NCT02268526|OG002|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
11211040|NCT02268526|OG000|Outcome|Total CSJ148 (Cohort 1 & Cohort 2)|Cohort 1: CSJ148 IV q 4weeks & Cohort 2: CSJ148 IV q 4 weeks
11211041|NCT02268526|OG001|Outcome|Cohort 2: Placebo|Cohort 2: Placebo IV q 4weeks
11211042|NCT02268526|OG000|Outcome|Cohort 2: CSJ148|Cohort 2: CSJ148 IV q 4weeks
11211043|NCT02268526|EG000|Reported Event|Placebo|Cohort 2: Placebo IV q 4weeks
11211044|NCT02268526|EG001|Reported Event|Total CSJ148|Cohort 1: CSJ148 IV q 4weeks & Cohort 2: CSJ148 IV q 4weeks
11211045|NCT02268786|BG000|Baseline|Group A: Genetic Screening by NGS|Group A: Genetic Screening by NGS (PGT-A)
11211046|NCT02268786|BG001|Baseline|Group B: Morphology Only|Group B: Morphology Only (Control)
11211047|NCT02268786|BG002|Baseline|Total|Total of all reporting groups
11211048|NCT02268786|FG000|Participant Flow|Group A: Genetic Screening by NGS|Group A: Genetic Screening by NGS (PGT-A)
11211049|NCT02268786|FG001|Participant Flow|Group B: Morphology Only|Group B: Morphology Only (Control)
11211050|NCT02268786|OG000|Outcome|Group A: Genetic Screening by NGS|Group A: Genetic Screening by NGS (PGT-A)
11211051|NCT02268786|OG001|Outcome|Group B: Morphology Only|Group B: Morphology Only (Control)
11211052|NCT02268786|EG000|Reported Event|Group A: Genetic Screening by NGS|Group A: Genetic Screening by NGS (PGT-A)
11211053|NCT02268786|EG001|Reported Event|Group B: Morphology Only|Group B: Morphology Only (Control)
11211054|NCT02268812|BG000|Baseline|Ziconotide Monotherapy|Participants who took ziconotide alone.
11211055|NCT02268812|BG001|Baseline|Ziconotide Combination|Participants who took ziconotide in combination with another intrathecal (IT) therapy.
11211056|NCT02268812|BG002|Baseline|Other IT Monotherapy|Participants who took an IT therapy other than ziconotide.
11211057|NCT02268812|BG003|Baseline|Other IT Combination|Participants who took two (or more) IT therapies in conjunction other than ziconotide.
11211058|NCT02268812|BG004|Baseline|Total|Total of all reporting groups
11211059|NCT02268812|FG000|Participant Flow|Ziconotide Monotherapy|Participants who took ziconotide alone.
11211060|NCT02268812|FG001|Participant Flow|Ziconotide Combination|Participants who took ziconotide in combination with another intrathecal (IT) therapy.
11211061|NCT02268812|FG002|Participant Flow|Other IT Monotherapy|Participants who took an IT therapy other than ziconotide.
11211062|NCT02268812|FG003|Participant Flow|Other IT Combination|Participants who took two (or more) IT therapies in conjunction other than ziconotide.
11211063|NCT02268812|OG000|Outcome|Ziconotide Monotherapy|Participants who took ziconotide alone.
11211064|NCT02268812|OG001|Outcome|Ziconotide Combination|Participants who took ziconotide in combination with another intrathecal (IT) therapy.
11211065|NCT02268812|OG002|Outcome|Other IT Monotherapy|Participants who took an IT therapy other than ziconotide.
11211066|NCT02268812|OG003|Outcome|Other IT Combination|Participants who took two (or more) IT therapies in conjunction other than ziconotide.
11211067|NCT02268812|EG000|Reported Event|Ziconotide Monotherapy|Participants who took ziconotide alone.
11211068|NCT02268812|EG001|Reported Event|Ziconotide Combination|Participants who took ziconotide in combination with another intrathecal (IT) therapy.
11211069|NCT02268812|EG002|Reported Event|Other IT Monotherapy|Participants who took an IT therapy other than ziconotide.
11211070|NCT02268812|EG003|Reported Event|Other IT Combination|Participants who took two (or more) IT therapies in conjunction other than ziconotide.
11211071|NCT02268851|BG000|Baseline|CLL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211072|NCT02268851|BG001|Baseline|MCL: Phase 1 Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211073|NCT02268851|BG002|Baseline|CLL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211074|NCT02268851|BG003|Baseline|MCL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211075|NCT02268851|BG004|Baseline|CLL Phase I/IICohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211076|NCT02268851|BG005|Baseline|MCL Phase I/II Cohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211077|NCT02268851|BG006|Baseline|Total|Total of all reporting groups
11211078|NCT02268851|FG000|Participant Flow|CLL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211079|NCT02268851|FG001|Participant Flow|MCL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211080|NCT02268851|FG002|Participant Flow|CLL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211081|NCT02268851|FG003|Participant Flow|MCL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211082|NCT02268851|FG004|Participant Flow|CLL: Phase I/II Cohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211083|NCT02268851|FG005|Participant Flow|MCL: Phase I/II Cohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211084|NCT02268851|OG000|Outcome|CLL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211085|NCT02268851|OG001|Outcome|MCL: Phase 1 Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211086|NCT02268851|OG002|Outcome|CLL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211087|NCT02268851|OG003|Outcome|MCL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211088|NCT02268851|OG004|Outcome|CLL Phase I/IICohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211089|NCT02268851|OG005|Outcome|MCL Phase I/II Cohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211090|NCT02268851|EG000|Reported Event|CLL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11286232|NCT02885350|OG001|Outcome|Epidural Fentanyl|"100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
11211091|NCT02268851|EG001|Reported Event|MCL: Phase I Cohort 1|Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211092|NCT02268851|EG002|Reported Event|CLL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211093|NCT02268851|EG003|Reported Event|MCL: Phase I Cohort 2|Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211094|NCT02268851|EG004|Reported Event|CLL: Phase I/IICohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211095|NCT02268851|EG005|Reported Event|MCL: Phase I/II Cohort 3 (RPD2)|Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
11211096|NCT02268864|BG000|Baseline|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
11211097|NCT02268864|BG001|Baseline|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
11211098|NCT02268864|BG002|Baseline|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
11211099|NCT02268864|BG003|Baseline|Total|Total of all reporting groups
11211100|NCT02268864|FG000|Participant Flow|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
11211101|NCT02268864|FG001|Participant Flow|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
11211102|NCT02268864|FG002|Participant Flow|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
11211103|NCT02268864|OG000|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
11211104|NCT02268864|OG001|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
11211105|NCT02268864|OG002|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
11211106|NCT02268864|OG000|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
11211107|NCT02268864|OG001|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
11211108|NCT02268864|OG002|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
11211109|NCT02268864|EG000|Reported Event|1-12 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has adverse events (AEs) that started before or on day 88 on treatment.
11211110|NCT02268864|EG001|Reported Event|12-24 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has AEs that started after day 88 on treatment.
11211111|NCT02268877|BG000|Baseline|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211112|NCT02268877|BG001|Baseline|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211113|NCT02268877|BG002|Baseline|Total|Total of all reporting groups
11211114|NCT02268877|FG000|Participant Flow|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211115|NCT02268877|FG001|Participant Flow|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211116|NCT02268877|OG000|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211117|NCT02268877|OG001|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211118|NCT02268877|EG000|Reported Event|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211119|NCT02268877|EG001|Reported Event|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
11211120|NCT02268942|BG000|Baseline|Per Protocol Population|Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
11211121|NCT02268942|FG000|Participant Flow|Per Protocol Population|Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
11211122|NCT02268942|OG000|Outcome|Per Protocol Population|Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
11211123|NCT02268942|EG000|Reported Event|Per Protocol Population|Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
11211124|NCT02268955|BG000|Baseline|Control Group|"Saline-only control group~Saline: Saline will be administered to the placebo group"
11211125|NCT02268955|BG001|Baseline|IV Ibuprofen|"Patients receiving intravenous ibuprofen therapy~IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic"
11211126|NCT02268955|BG002|Baseline|Total|Total of all reporting groups
11211127|NCT02268955|FG000|Participant Flow|Control Group|"Saline-only control group~Saline: Saline will be administered to the placebo group"
11211128|NCT02268955|FG001|Participant Flow|IV Ibuprofen|"Patients receiving intravenous ibuprofen therapy~IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic"
11211129|NCT02268955|OG000|Outcome|Control Group: Adults Age 18-55 Years|"Saline-only control group~Saline: Saline will be administered to the placebo group"
11211130|NCT02268955|OG001|Outcome|IV Ibuprofen: Adults Age 18-55 Years|"Patients receiving intravenous ibuprofen therapy~IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic"
11211131|NCT02268955|EG000|Reported Event|Control Group|"Saline-only control group~Saline: Saline will be administered to the placebo group"
11211132|NCT02268955|EG001|Reported Event|IV Ibuprofen|"Patients receiving intravenous ibuprofen therapy~IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic"
11211133|NCT02268994|BG000|Baseline|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211134|NCT02268994|BG001|Baseline|Placebo|"Matching Placebo~Placebo: Matching placebo"
11211135|NCT02268994|BG002|Baseline|Total|Total of all reporting groups
11211136|NCT02268994|FG000|Participant Flow|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211137|NCT02268994|FG001|Participant Flow|Placebo|"Matching Placebo~Placebo: Matching placebo"
11211138|NCT02268994|OG000|Outcome|KRX-0502 (Ferric Citrate)|"1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron"
11211139|NCT02268994|OG001|Outcome|Placebo|"Matching Placebo~Placebo: Matching placebo"
11211140|NCT02268994|OG000|Outcome|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211141|NCT02268994|OG000|Outcome|KRX-0502 (Ferric Citrate)|"1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211142|NCT02268994|OG000|Outcome|KRX-0502 (Ferric Citrate)|"1 gr of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211143|NCT02268994|EG000|Reported Event|KRX-0502 (Ferric Citrate)|"1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron~ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron"
11211144|NCT02268994|EG001|Reported Event|Placebo|"Matching Placebo~Placebo: Matching placebo"
11286233|NCT02885350|OG002|Outcome|Spinal Sufentanil|"5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
11286234|NCT02885350|OG003|Outcome|Epidural Sufentanil|"20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
11286235|NCT02885350|EG000|Reported Event|Spinal Fentanyl|"20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
10819850|NCT00050960|BG000|Baseline|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
10819851|NCT00050960|BG001|Baseline|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
10819852|NCT00050960|BG002|Baseline|Total|Total of all reporting groups
10819853|NCT00050960|FG000|Participant Flow|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
10819854|NCT00050960|FG001|Participant Flow|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
10819855|NCT00050960|OG000|Outcome|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
10819856|NCT00050960|OG001|Outcome|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
10819857|NCT00050960|EG000|Reported Event|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
10819858|NCT00050960|EG001|Reported Event|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
10819859|NCT00050986|BG000|Baseline|Temozolomide and R115777|
10819860|NCT00050986|FG000|Participant Flow|Temozolomide and R115777|
10819861|NCT00050986|OG000|Outcome|Temozolomide and R115777|
10819862|NCT00050986|EG000|Reported Event|Temozolomide and R115777|
10819863|NCT00051025|BG000|Baseline|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819864|NCT00051025|BG001|Baseline|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819865|NCT00051025|BG002|Baseline|Total|Total of all reporting groups
10819866|NCT00051025|FG000|Participant Flow|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819867|NCT00051025|FG001|Participant Flow|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819868|NCT00051025|OG000|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819869|NCT00051025|OG001|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819870|NCT00051025|EG000|Reported Event|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819871|NCT00051025|EG001|Reported Event|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
10819872|NCT00051168|BG000|Baseline|Travatan|Travoprost (0.004%)
10819873|NCT00051168|FG000|Participant Flow|Travatan|Travoprost (0.004%)
10819874|NCT00051168|OG000|Outcome|Travatan|Travoprost (0.004%)
10819875|NCT00051168|EG000|Reported Event|Travatan|Travoprost (0.004%)
10819876|NCT00051311|BG000|Baseline|Donor|Apheresis: Donors will undergo apheresis to collect stem cells for a stem cell transplant for the recipient.
10819877|NCT00051311|BG001|Baseline|Recipient|"Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells.~Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD).~Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD)."
10819878|NCT00051311|BG002|Baseline|Total|Total of all reporting groups
10819879|NCT00051311|FG000|Participant Flow|Donor|Apheresis: Donors will undergo apheresis to collect stem cells for a stem cell transplant for the recipient.
10819880|NCT00051311|FG001|Participant Flow|Recipient|"Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells.~Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD).~Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD)."
10819881|NCT00051311|OG000|Outcome|Recipient|"Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells.~Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD).~Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD)."
10819882|NCT00051311|EG000|Reported Event|Recipient|"Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells.~Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD).~Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD)."
10819883|NCT00051363|BG000|Baseline|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
10819884|NCT00051363|BG001|Baseline|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
10819885|NCT00051363|BG002|Baseline|Total|Total of all reporting groups
10819886|NCT00051363|FG000|Participant Flow|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
10819887|NCT00051363|FG001|Participant Flow|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
10819888|NCT00051363|OG000|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
10819889|NCT00051363|OG001|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
10819890|NCT00051363|EG000|Reported Event|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
10819891|NCT00051363|EG001|Reported Event|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
10819892|NCT00051558|BG000|Baseline|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
10819893|NCT00051558|BG001|Baseline|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
10819894|NCT00051558|BG002|Baseline|Total|Total of all reporting groups
10819895|NCT00051558|FG000|Participant Flow|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
10819896|NCT00051558|FG001|Participant Flow|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
10819897|NCT00051558|OG000|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
10819898|NCT00051558|OG001|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
10819899|NCT00051558|EG000|Reported Event|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
10819900|NCT00051558|EG001|Reported Event|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
10819901|NCT00051636|BG000|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819902|NCT00051636|BG001|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819903|NCT00051636|BG002|Baseline|Total|Total of all reporting groups
10819904|NCT00051636|FG000|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819905|NCT00051636|FG001|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819906|NCT00051636|OG000|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819907|NCT00051636|OG001|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819908|NCT00051636|EG000|Reported Event|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819909|NCT00051636|EG001|Reported Event|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10819910|NCT00052078|BG000|Baseline|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
10819911|NCT00052078|BG001|Baseline|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819912|NCT00052078|BG002|Baseline|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819913|NCT00052078|BG003|Baseline|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
10819914|NCT00052078|BG004|Baseline|Total|Total of all reporting groups
10819915|NCT00052078|FG000|Participant Flow|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
10819916|NCT00052078|FG001|Participant Flow|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819917|NCT00052078|FG002|Participant Flow|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
11211145|NCT02269098|BG000|Baseline|Intervention|"Diabetes survival skills self-management education (G meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
11211146|NCT02269098|BG001|Baseline|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
11211147|NCT02269098|BG002|Baseline|Total|Total of all reporting groups
11211148|NCT02269098|FG000|Participant Flow|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
11211149|NCT02269098|FG001|Participant Flow|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
11211150|NCT02269098|OG000|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
11211151|NCT02269098|OG001|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
11211152|NCT02269098|OG000|Outcome|Intervention|"Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation.~Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Navigation included securing a primary care"
11211153|NCT02269098|EG000|Reported Event|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
11211154|NCT02269098|EG001|Reported Event|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
11286236|NCT02885350|EG001|Reported Event|Epidural Fentanyl|"100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
10819918|NCT00052078|FG003|Participant Flow|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
10819919|NCT00052078|OG000|Outcome|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
10819920|NCT00052078|OG001|Outcome|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819921|NCT00052078|OG002|Outcome|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819922|NCT00052078|OG003|Outcome|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
10819923|NCT00052078|EG000|Reported Event|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
10819924|NCT00052078|EG001|Reported Event|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819925|NCT00052078|EG002|Reported Event|3 Combination Setraline + CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
10819926|NCT00052078|EG003|Reported Event|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
10819927|NCT00052429|BG000|Baseline|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
10819928|NCT00052429|FG000|Participant Flow|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
10819929|NCT00052429|OG000|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
10819930|NCT00052429|EG000|Reported Event|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
10819931|NCT00052442|BG000|Baseline|135 mg/m2 Pralatrexate 1/2 Weeks|Pralatrexate 135 mg/m^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
10819932|NCT00052442|BG001|Baseline|30 mg/m2 Pralatrexate 3/4 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
10819933|NCT00052442|BG002|Baseline|30 mg/m2 Pralatrexate 6/7 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819934|NCT00052442|BG003|Baseline|45 mg/m2 Pralatrexate 6/7 Weeks|Pralatrexate 45 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819935|NCT00052442|BG004|Baseline|270 mg/m2 Pralatrexate 2/4 Weeks|Pralatrexate 270 mg/m^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
10819936|NCT00052442|BG005|Baseline|Total|Total of all reporting groups
10819937|NCT00052442|FG000|Participant Flow|135 mg/m^2 Pralatrexate 1/2 Weeks|Pralatrexate 135 mg/m^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
10819938|NCT00052442|FG001|Participant Flow|30 mg/m^2 Pralatrexate 3/4 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
10819939|NCT00052442|FG002|Participant Flow|30 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819940|NCT00052442|FG003|Participant Flow|45 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 45 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
11211155|NCT02269124|BG000|Baseline|Conventional Measures Only First, Then Conventional Methods + Hearing Aid|"Of the participants who completed the study, twenty (20) were assigned to complete the 3-month Conventional Measures Only arm first, during which only FM system and preferential seating were used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month Conventional Measures + Hearing Aid arm, during which conventional measures and a hearing aid was used."
11211156|NCT02269124|BG001|Baseline|Conventional Measures + Hearing Aid First, Then Conventional Methods Only|"Of the participants who completed the study, fourteen (14) were assigned to complete the 3-month Conventional Measures + Hearing Aid arm first, during which an FM system, preferential seating, and a hearing aid were all used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month Conventional Measures Only arm, during which only FM system and preferential seating were used."
11211157|NCT02269124|BG002|Baseline|Total|Total of all reporting groups
11211158|NCT02269124|FG000|Participant Flow|Conventional Measures Only First; Then Conventional Measures + Hearing Aid|"This group was randomized to complete the 3-month Conventional Measures Only arm first, followed immediately by the 3-month Conventional Measures + Hearing Aid arm. There was no washout period between arms."
11211159|NCT02269124|FG001|Participant Flow|Conventional Measures + Hearing Aid First; Then Conventional Measures Only|"This group was randomized to complete the 3-month Conventional Measures + Hearing Aid arm first, followed immediately by the 3-month Conventional Measures Only arm. There was no washout period between arms."
11211160|NCT02269124|OG000|Outcome|Conventional Methods Only First, Then Conventional Methods + Hearing Aid|"Subjects randomized into the conventional methods arm began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid."
11211161|NCT02269124|OG001|Outcome|Conventional Methods + Hearing Aid First, Then Conventional Methods Only|"Subjects randomized into the conventional methods + hearing aid arm began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only."
11211162|NCT02269124|OG000|Outcome|Conventional Methods Only First, Then Conventional Methods + Hearing Aid|"Subjects randomized into the conventional methods arm began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods and a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid."
11211163|NCT02269124|EG000|Reported Event|Conventional Measures Only First; Then Conventional Measures + Hearing Aid|"This group was randomized to complete the 3-month Conventional Measures Only arm first, followed immediately by the 3-month Conventional Measures + Hearing Aid arm."
11211164|NCT02269124|EG001|Reported Event|Conventional Measures + Hearing Aid First; Then Conventional Measures Only|"This group was randomized to complete the 3-month Conventional Measures + Hearing Aid arm first, followed immediately by the 3-month Conventional Measures Only arm."
11211165|NCT02269163|BG000|Baseline|Cohort 1 - Adult|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 1 consisted of adult subjects aged 17-80 years.
11211166|NCT02269163|BG001|Baseline|Cohort 2 - Pediatric|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 2 consisted of pediatric subjects aged 2 to < 17 years.
11211167|NCT02269163|BG002|Baseline|Total|Total of all reporting groups
11211168|NCT02269163|FG000|Participant Flow|Cohort 1 - Adult|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 1 consisted of adult subjects aged 17-80 years.
11211169|NCT02269163|FG001|Participant Flow|Cohort 2 - Pediatric|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 2 consisted of pediatric subjects aged 2 to < 17 years.
11211170|NCT02269163|OG000|Outcome|CP Treatment Period|The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.
11211171|NCT02269163|OG001|Outcome|Prometic IGIV 10% Treatment Period|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion
11211172|NCT02269163|OG002|Outcome|Prometic IGIV 10% Treatment Period (Cohort 1)|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (adult population)
11211173|NCT02269163|OG003|Outcome|Prometic IGIV 10% Treatment Period (Cohort 2)|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (pediatric population)
10819941|NCT00052442|FG004|Participant Flow|270 mg/m^2 Pralatrexate 2/4 Weeks|Pralatrexate 270 mg/m^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
10819942|NCT00052442|OG000|Outcome|135 mg/m^2 Pralatrexate 1/2 Weeks|Pralatrexate 135 mg/m^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
10819943|NCT00052442|OG001|Outcome|30 mg/m^2 Pralatrexate 3/4 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
11211174|NCT02269163|EG000|Reported Event|CP Treatment Period|The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.
11211175|NCT02269163|EG001|Reported Event|Prometic IGIV 10% Treatment Period|The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion.
11211176|NCT02269241|BG000|Baseline|LF111 (Drospirenone 4mg)|Single treatment arm receives LF111 film-coated tablets (24 white tablets containing 4.0 mg drospirenone, 4 green placebo tablets), oral administration once daily.
11211177|NCT02269241|FG000|Participant Flow|Drospirenone 4 mg|Single treatment arm receives LF111 film-coated tablets (24 white tablets containing 4.0 mg drospirenone, 4 green placebo tablets), oral administration once daily.
11211178|NCT02269241|OG000|Outcome|Drospirenone 4 mg|Single treatment arm receives LF111 film-coated tablets (24 white tablets containing 4.0 mg drospirenone, 4 green placebo tablets), oral administration once daily.
11211179|NCT02269241|OG000|Outcome|LF111 (Drospirenone)|"single treatment arm receives LF111~LF111 (drospirenone): One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle."
11211180|NCT02269241|EG000|Reported Event|Drospirenone 4mg|Single treatment arm receives LF111 film-coated tablets (24 white tablets containing 4.0 mg drospirenone, 4 green placebo tablets), oral administration once daily.
11211181|NCT02269423|BG000|Baseline|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211182|NCT02269423|BG001|Baseline|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211183|NCT02269423|BG002|Baseline|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211184|NCT02269423|BG003|Baseline|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
11211185|NCT02269423|BG004|Baseline|Total|Total of all reporting groups
11211186|NCT02269423|FG000|Participant Flow|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211187|NCT02269423|FG001|Participant Flow|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211188|NCT02269423|FG002|Participant Flow|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211189|NCT02269423|FG003|Participant Flow|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
11211190|NCT02269423|OG000|Outcome|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211191|NCT02269423|OG001|Outcome|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211192|NCT02269423|OG002|Outcome|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211193|NCT02269423|OG003|Outcome|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
11211194|NCT02269423|EG000|Reported Event|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211195|NCT02269423|EG001|Reported Event|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211196|NCT02269423|EG002|Reported Event|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
11211197|NCT02269423|EG003|Reported Event|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
11211198|NCT02269475|BG000|Baseline|MEDI3250|MEDI3250, 0.2mL as nasal spray
11211199|NCT02269475|BG001|Baseline|Placebo|Placebo, 0.2mL as nasal spray
11211200|NCT02269475|BG002|Baseline|Total|Total of all reporting groups
11211201|NCT02269475|FG000|Participant Flow|MEDI3250|MEDI3250, 0.2mL as nasal spray
11211202|NCT02269475|FG001|Participant Flow|Placebo|Placebo, 0.2mL as nasal spray
11211203|NCT02269475|OG000|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
11211204|NCT02269475|OG001|Outcome|Placebo|Placebo, 0.2mL as nasal spray
11211205|NCT02269475|EG000|Reported Event|MEDI3250|MEDI3250, 0.2mL as nasal spray
11211206|NCT02269475|EG001|Reported Event|Placebo|Placebo, 0.2mL as nasal spray
11211207|NCT02269475|EG002|Reported Event|Total Number|
11211208|NCT02269488|BG000|Baseline|MEDI3250|MEDI3250 was administered to all subjects.
11211209|NCT02269488|FG000|Participant Flow|MEDI3250|MEDI3250 was administered to all subjects.
11211210|NCT02269488|OG000|Outcome|MEDI3250|MEDI3250 was administered to all subjects.
11211211|NCT02269488|EG000|Reported Event|MEDI3250|MEDI3250 was administered to all subjects.
10819944|NCT00052442|OG002|Outcome|30 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
11286237|NCT02885350|EG002|Reported Event|Spinal Sufentanil|"5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.~Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique"
10819945|NCT00052442|OG003|Outcome|45 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 45 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819946|NCT00052442|OG004|Outcome|270 mg/m^2 Pralatrexate 2/4 Weeks|Pralatrexate 270 mg/m^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
10819947|NCT00052442|EG000|Reported Event|135 mg/m^2 Pralatrexate 1/2 Weeks|Pralatrexate 135 mg/m^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
10819948|NCT00052442|EG001|Reported Event|30 mg/m^2 Pralatrexate 3/4 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
11211212|NCT02269631|BG000|Baseline|Legume Diet Group|"Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.~Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals~Smartpill: to assess how long food takes to pass through the digestive system~legumes: about 1 1/2 cups of legumes included in lunch and dinner meals"
11211213|NCT02269631|BG001|Baseline|Control Diet Group|"Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.~Control diet group: no legumes in lunch or dinner meals~Smartpill: to assess how long food takes to pass through the digestive system"
11211214|NCT02269631|BG002|Baseline|Total|Total of all reporting groups
11211215|NCT02269631|FG000|Participant Flow|Legume Diet Group|"Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.~Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals~Smartpill: to assess how long food takes to pass through the digestive system~legumes: about 1 1/2 cups of legumes included in lunch and dinner meals"
11211216|NCT02269631|FG001|Participant Flow|Control Diet Group|"Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.~Control diet group: no legumes in lunch or dinner meals~Smartpill: to assess how long food takes to pass through the digestive system"
11211217|NCT02269631|OG000|Outcome|Legume Diet Group|"Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.~Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals~Smartpill: to assess how long food takes to pass through the digestive system~legumes: about 1 1/2 cups of legumes included in lunch and dinner meals"
11211218|NCT02269631|OG001|Outcome|Control Diet Group|"Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.~Control diet group: no legumes in lunch or dinner meals~Smartpill: to assess how long food takes to pass through the digestive system"
11286238|NCT02885350|EG003|Reported Event|Epidural Sufentanil|"20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.~Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter."
10819949|NCT00052442|EG002|Reported Event|30 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 30 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819950|NCT00052442|EG003|Reported Event|45 mg/m^2 Pralatrexate 6/7 Weeks|Pralatrexate 45 mg/m^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
10819951|NCT00052442|EG004|Reported Event|270 mg/m^2 Pralatrexate 2/4 Weeks|Pralatrexate 270 mg/m^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
10819952|NCT00052715|BG000|Baseline|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
10819953|NCT00052715|FG000|Participant Flow|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
10819954|NCT00052715|OG000|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
10819955|NCT00052715|EG000|Reported Event|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
10819956|NCT00052910|BG000|Baseline|Arm I (5-FU/LV)|Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
10819957|NCT00052910|BG001|Baseline|Arm II (ECF)|Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
10819958|NCT00052910|BG002|Baseline|Total|Total of all reporting groups
10819959|NCT00052910|FG000|Participant Flow|Arm I (5-FU/LV)|Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
10819960|NCT00052910|FG001|Participant Flow|Arm II (ECF)|Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
10819961|NCT00052910|OG000|Outcome|Arm I (5-FU/LV)|Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
10819962|NCT00052910|OG001|Outcome|Arm II (ECF)|Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
10819963|NCT00052910|EG000|Reported Event|Arm I (5-FU/LV)|Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
10819964|NCT00052910|EG001|Reported Event|Arm II (ECF)|Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
10819965|NCT00052962|BG000|Baseline|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819966|NCT00052962|BG001|Baseline|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819967|NCT00052962|BG002|Baseline|Total|Total of all reporting groups
10819968|NCT00052962|FG000|Participant Flow|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819969|NCT00052962|FG001|Participant Flow|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819970|NCT00052962|OG000|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819971|NCT00052962|OG001|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
11211219|NCT02269631|EG000|Reported Event|Legume Diet Group|"Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.~Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals~Smartpill: to assess how long food takes to pass through the digestive system~legumes: about 1 1/2 cups of legumes included in lunch and dinner meals"
11211220|NCT02269631|EG001|Reported Event|Control Diet Group|"Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.~Control diet group: no legumes in lunch or dinner meals~Smartpill: to assess how long food takes to pass through the digestive system"
11211221|NCT02269657|BG000|Baseline|Subject Cohort|Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
11286239|NCT02885506|BG000|Baseline|Cohort 1|"10 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10819972|NCT00052962|EG000|Reported Event|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
11211222|NCT02269657|FG000|Participant Flow|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
11211223|NCT02269657|OG000|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
11211224|NCT02269657|OG001|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
11211225|NCT02269657|OG002|Outcome|Natural Standing Position|Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
11211226|NCT02269657|EG000|Reported Event|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
11211227|NCT02269709|BG000|Baseline|ARFI Ultrasound|Subjects were pediatric patients who had undergone a Fontan operation. Subjects underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure the stiffness of the tissue.
11211228|NCT02269709|FG000|Participant Flow|ARFI Ultrasound|"Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation.~The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness."
11211229|NCT02269709|OG000|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
11211230|NCT02269709|OG000|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation. The blood pressure in the IVC (interior vena cava) was measured.
11211231|NCT02269709|EG000|Reported Event|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
11211232|NCT02269787|BG000|Baseline|Enhanced Telephone Monitoring|Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
11211233|NCT02269787|BG001|Baseline|Usual Care|Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
11211234|NCT02269787|BG002|Baseline|Total|Total of all reporting groups
11211235|NCT02269787|FG000|Participant Flow|Enhanced Telephone Monitoring|Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
11211236|NCT02269787|FG001|Participant Flow|Usual Care|Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
11211237|NCT02269787|OG000|Outcome|Enhanced Telephone Monitoring|Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
11211238|NCT02269787|OG001|Outcome|Usual Care|Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
11211239|NCT02269787|EG000|Reported Event|Enhanced Telephone Monitoring|Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
11211240|NCT02269787|EG001|Reported Event|Usual Care|Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
11211241|NCT02269943|BG000|Baseline|CC-486 200 mg|Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.
11211242|NCT02269943|BG001|Baseline|CC-486 300 mg|Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.
11211243|NCT02269943|BG002|Baseline|Total|Total of all reporting groups
11211244|NCT02269943|FG000|Participant Flow|CC-486 200 mg|Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.
11211245|NCT02269943|FG001|Participant Flow|CC-486 300 mg|Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.
11286240|NCT02885506|BG001|Baseline|Cohort 2|"30 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286241|NCT02885506|BG002|Baseline|Cohort 3|"100 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211246|NCT02269943|OG000|Outcome|CC-486 200 mg|Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.
11211247|NCT02269943|OG001|Outcome|CC-486 300 mg|Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.
11211248|NCT02269943|EG000|Reported Event|CC-486 200 mg|Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.
11211249|NCT02269943|EG001|Reported Event|CC-486 300 mg|Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.
11211250|NCT02270060|BG000|Baseline|Music Therapy Group|"Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.~Music Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."
11211251|NCT02270060|BG001|Baseline|Music Listening Group|"Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.~Music Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist."
11211252|NCT02270060|BG002|Baseline|Control Group|Patient receives standard care and waits in treatment room/bay for twenty minutes.
11211253|NCT02270060|BG003|Baseline|Total|Total of all reporting groups
11211254|NCT02270060|FG000|Participant Flow|Music Therapy Group|"Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.~Music Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."
11211255|NCT02270060|FG001|Participant Flow|Music Listening Group|"Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.~Music Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist."
11211256|NCT02270060|FG002|Participant Flow|Control Group|Patient receives standard care and waits in treatment room/bay for twenty minutes.
11211257|NCT02270060|OG000|Outcome|Music Therapy Group|"Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.~Music Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."
11211258|NCT02270060|OG001|Outcome|Music Listening Group|"Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.~Music Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist."
11211259|NCT02270060|OG002|Outcome|Control Group|Patient receives standard care and waits in treatment room/bay for twenty minutes.
11211260|NCT02270060|EG000|Reported Event|Music Therapy Group|"Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.~Music Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."
11211261|NCT02270060|EG001|Reported Event|Music Listening Group|"Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.~Music Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist."
11211262|NCT02270060|EG002|Reported Event|Control Group|Patient receives standard care and waits in treatment room/bay for twenty minutes.
11211263|NCT02270242|BG000|Baseline|Placebo + Ticagrelor|placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months
11211264|NCT02270242|BG001|Baseline|Aspirin + Ticagrelor|enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months
11211265|NCT02270242|BG002|Baseline|Total|Total of all reporting groups
11211266|NCT02270242|FG000|Participant Flow|Placebo + Ticagrelor|placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months
11211267|NCT02270242|FG001|Participant Flow|Aspirin + Ticagrelor|enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months
11211268|NCT02270242|OG000|Outcome|Placebo + Ticagrelor|placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months
11211269|NCT02270242|OG001|Outcome|Aspirin + Ticagrelor|enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months
11211270|NCT02270242|EG000|Reported Event|Placebo + Ticagrelor|placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg-100mg and ticagrelor 90mg tablet bid for 12 months
11211271|NCT02270242|EG001|Reported Event|Aspirin + Ticagrelor|enteric coated aspirin 81mg-100mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 12 months
11211272|NCT02270255|BG000|Baseline|Control Group|"Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.~Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region~1% Xylocaine: 5ml of 1% Xylocaine"
11211273|NCT02270255|BG001|Baseline|Sup Hypogastric Nerve Block Group|"Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.~Superior hypogastric nerve block: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.~0.75% Ropivacaine: 20 ml of 0.75% Ropivacaine"
11211274|NCT02270255|BG002|Baseline|Total|Total of all reporting groups
11211275|NCT02270255|FG000|Participant Flow|Control Group|"Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.~Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region~1% Xylocaine: 5ml of 1% Xylocaine"
11211276|NCT02270255|FG001|Participant Flow|Sup Hypogastric Nerve Block Group|"Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.~Superior hypogastric nerve block: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.~0.75% Ropivacaine: 20 ml of 0.75% Ropivacaine"
11211277|NCT02270255|OG000|Outcome|Control Group|"Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.~Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region~1% Xylocaine: 5ml of 1% Xylocaine"
11211278|NCT02270255|OG001|Outcome|Sup Hypogastric Nerve Block Group|"Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.~Superior hypogastric nerve block: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.~0.75% Ropivacaine: 20 ml of 0.75% Ropivacaine"
11211279|NCT02270255|EG000|Reported Event|Control Group|"Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.~Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region~1% Xylocaine: 5ml of 1% Xylocaine"
11211280|NCT02270255|EG001|Reported Event|Sup Hypogastric Nerve Block Group|"Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.~Superior hypogastric nerve block: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.~0.75% Ropivacaine: 20 ml of 0.75% Ropivacaine"
11211281|NCT02270515|BG000|Baseline|PCMH-KD Dialysis Care|Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist.
11211282|NCT02270515|FG000|Participant Flow|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and a pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
11211283|NCT02270515|OG000|Outcome|Baseline|KDQOL collected at Baseline
11211284|NCT02270515|OG001|Outcome|6 Months|KDQOL collected at 6 months
11211285|NCT02270515|OG002|Outcome|12 Months|KDQOL collected at 12 months
11211286|NCT02270515|OG003|Outcome|18 Months|KDQOL collected at 18 months
11211287|NCT02270515|OG000|Outcome|Change 0-6 Months|Change of mean score from Baseline (0) to 6 months
11211288|NCT02270515|OG001|Outcome|Change 6-12 Months|Change of mean score from 6 months to 12 months
11211289|NCT02270515|OG002|Outcome|Change 12-18 Months|Change of mean score from 12 months to 18 months
11211290|NCT02270515|OG003|Outcome|Change 0-18 Months|Change of mean score from Baseline (0) to 18 months
11211291|NCT02270515|EG000|Reported Event|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
11211292|NCT02270645|BG000|Baseline|Treatment: 595/1064 Multiplex Laser|"Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.~Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.~595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting."
11211293|NCT02270645|BG001|Baseline|Control|"Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.~Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment."
11211294|NCT02270645|BG002|Baseline|Total|Total of all reporting groups
11286242|NCT02885506|BG003|Baseline|Cohort 4|"250 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286243|NCT02885506|BG004|Baseline|Cohort 5|"500 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211295|NCT02270645|FG000|Participant Flow|Treatment: 595/1064 Multiplex Laser|"Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.~Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.~595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting."
11211296|NCT02270645|FG001|Participant Flow|Control|"Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.~Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment."
11211297|NCT02270645|OG000|Outcome|Treatment: 595/1064 Multiplex Laser|"Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.~Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.~595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting."
11211298|NCT02270645|OG001|Outcome|Control|"Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.~Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment."
11211299|NCT02270645|EG000|Reported Event|Treatment: 595/1064 Multiplex Laser|"Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.~Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.~595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting."
11211300|NCT02270645|EG001|Reported Event|Control|"Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.~Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.~Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment."
11211301|NCT02270671|BG000|Baseline|Placebo|"The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~Placebo: Placebo Training"
11211302|NCT02270671|BG001|Baseline|Intervention|"The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~ABMT: Attention Bias Modification Training"
11211303|NCT02270671|BG002|Baseline|Total|Total of all reporting groups
11211304|NCT02270671|FG000|Participant Flow|Placebo|"The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~Placebo: Placebo Training"
11286244|NCT02885506|BG005|Baseline|Cohort 6|"750 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10819973|NCT00052962|EG001|Reported Event|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
10819974|NCT00053014|BG000|Baseline|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
11211305|NCT02270671|FG001|Participant Flow|Intervention|"The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~ABMT: Attention Bias Modification Training"
11211306|NCT02270671|OG000|Outcome|Placebo|"The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~Placebo: Placebo Training"
11211307|NCT02270671|OG001|Outcome|Intervention|"The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~ABMT: Attention Bias Modification Training"
11211308|NCT02270671|EG000|Reported Event|Placebo|"The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~Placebo: Placebo Training"
11211309|NCT02270671|EG001|Reported Event|Intervention|"The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.~ABMT: Attention Bias Modification Training"
11211310|NCT02270736|BG000|Baseline|Double-blind MP: Placebo (Age 6 to 17 Years)|Participants received placebo via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks. Volumes were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm.
11211311|NCT02270736|BG001|Baseline|Double-blind, MP: NT 201 (Age 6 to 17 Years)|Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211312|NCT02270736|BG002|Baseline|Open-label, MP: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211313|NCT02270736|BG003|Baseline|Total|Total of all reporting groups
11211314|NCT02270736|FG000|Participant Flow|Double-blind MP: Placebo (Age 6 to 17 Years)|Participants received placebo via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks. Volumes were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm.
11211315|NCT02270736|FG001|Participant Flow|Double-blind, MP: NT 201 (Age 6 to 17 Years)|Participants received NT 201 (up to 2.5 Units per kilogram [U/kg] body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211316|NCT02270736|FG002|Participant Flow|Open-label, MP: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211317|NCT02270736|FG003|Participant Flow|OLEX: NT 201 (Age 6 to 17 Years)|"Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total). This arm consisted of participants who participated in MP arms Double-blind, MP: placebo (age 6 to 17 years) and Double-blind, MP: NT 201 (age 6 to 17 years)."
11211318|NCT02270736|FG004|Participant Flow|OLEX: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total).
11211319|NCT02270736|OG000|Outcome|Double-blind MP: Placebo (Age 6 to 17 Years)|Participants received placebo via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks. Volumes were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm.
11211320|NCT02270736|OG001|Outcome|Double-blind, MP: NT 201 (Age 6 to 17 Years)|Participants received NT 201 (up to 2.5 Units per kilogram [U/kg] body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211321|NCT02270736|OG001|Outcome|Double-blind, MP: NT 201 (Age 6 to 17 Years)|Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211322|NCT02270736|OG002|Outcome|Open-label, MP: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11286245|NCT02885506|BG006|Baseline|Cohort 7|"1000 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211323|NCT02270736|OG003|Outcome|OLEX: NT 201 (Age 6 to 17 Years)|"Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total). This arm consisted of participants who participated in MP arms Double-blind, MP: placebo (age 6 to 17 years) and Double-blind, MP: NT 201 (age 6 to 17 years)."
11211324|NCT02270736|OG004|Outcome|OLEX: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total).
11211325|NCT02270736|EG000|Reported Event|Double-blind MP: Placebo (Age 6 to 17 Years)|Participants received placebo via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks. Volumes were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm.
11211326|NCT02270736|EG001|Reported Event|Double-blind, MP: NT 201 (Age 6 to 17 Years)|Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211327|NCT02270736|EG002|Reported Event|Open-label, MP: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
11211328|NCT02270736|EG003|Reported Event|OLEX: NT 201 (Age 6 to 17 Years)|"Participants received NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total). This arm consisted of participants who participated in MP arms Double-blind, MP: placebo (age 6 to 17 years) and Double-blind, MP: NT 201 (age 6 to 17 years)."
11211329|NCT02270736|EG004|Reported Event|OLEX: NT 201 (Age 2 to 5 Years)|Participants received NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total).
11211330|NCT02270944|BG000|Baseline|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
11211331|NCT02270944|BG001|Baseline|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
11211332|NCT02270944|BG002|Baseline|Total|Total of all reporting groups
11211333|NCT02270944|FG000|Participant Flow|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
11211334|NCT02270944|FG001|Participant Flow|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
11211335|NCT02270944|OG000|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
11211336|NCT02270944|OG001|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
11211337|NCT02270944|OG000|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.
11211338|NCT02270944|EG000|Reported Event|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
11211339|NCT02270944|EG001|Reported Event|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
11211340|NCT02270983|BG000|Baseline|Placebo|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211341|NCT02270983|BG001|Baseline|Linaclotide 145 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211342|NCT02270983|BG002|Baseline|Linaclotide 290 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211343|NCT02270983|BG003|Baseline|Total|Total of all reporting groups
11211344|NCT02270983|FG000|Participant Flow|Placebo|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211345|NCT02270983|FG001|Participant Flow|Linaclotide 145 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211346|NCT02270983|FG002|Participant Flow|Linaclotide 290 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211347|NCT02270983|OG000|Outcome|Placebo|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211348|NCT02270983|OG001|Outcome|Linaclotide 145 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211349|NCT02270983|OG002|Outcome|Linaclotide 290 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211350|NCT02270983|EG000|Reported Event|Placebo|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211351|NCT02270983|EG001|Reported Event|Linaclotide 145 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211352|NCT02270983|EG002|Reported Event|Linaclotide 290 Micrograms|Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
11211353|NCT02271217|BG000|Baseline|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
11211354|NCT02271217|BG001|Baseline|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
11211355|NCT02271217|BG002|Baseline|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
11211356|NCT02271217|BG003|Baseline|Total|Total of all reporting groups
11211357|NCT02271217|FG000|Participant Flow|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
11211358|NCT02271217|FG001|Participant Flow|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
11211359|NCT02271217|FG002|Participant Flow|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
11211360|NCT02271217|OG000|Outcome|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
11211361|NCT02271217|OG001|Outcome|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
11211362|NCT02271217|OG002|Outcome|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
11211363|NCT02271217|EG000|Reported Event|Placebo|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~Placebo"
11211364|NCT02271217|EG001|Reported Event|Dalfampridine-ER 7.5 mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 7.5mg"
11211365|NCT02271217|EG002|Reported Event|Dalfampridine-ER 10mg|"Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.~dalfampridine-ER 10mg"
11211366|NCT02271386|BG000|Baseline|Intervention Clinicians|Clinicians in the intervention arm received the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.
11211367|NCT02271386|BG001|Baseline|Control Clinicians|Clinicians in the control arm received no intervention for the first 8 months of the study, then received the full SPA intervention for the last 8 months of the study.
11211368|NCT02271386|BG002|Baseline|Patients of Intervention Clinicians|Children aged 5-12 with ADHD seen by a clinician in the intervention group during the study period.
11211369|NCT02271386|BG003|Baseline|Patients of Control Clinicians|Children aged 5-12 with an ADHD diagnosis seen by clinicians in the control group during the study period.
11211370|NCT02271386|BG004|Baseline|Total|Total of all reporting groups
11211371|NCT02271386|FG000|Participant Flow|Intervention Clinicians|Clinicians in the intervention arm received the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.
11211372|NCT02271386|FG001|Participant Flow|Control Clinicians|Clinicians in the control arm received no intervention for the first 8 months of the study, then received the full SPA intervention for the last 8 months of the study.
11211373|NCT02271386|FG002|Participant Flow|Patients of Intervention Clinicians|Children aged 5-12 with ADHD seen by a clinician in the intervention group during the study period.
11211374|NCT02271386|FG003|Participant Flow|Patients of Control Clinicians|Children aged 5-12 with an ADHD diagnosis seen by clinicians in the control group during the study period.
11211375|NCT02271386|OG000|Outcome|Patients of Intervention Clinicians|Children aged 5-12 with ADHD seen by a clinician in the intervention group during the study period.
11211376|NCT02271386|OG001|Outcome|Patients of Control Clinicians|Children aged 5-12 with an ADHD diagnosis seen by clinicians in the control group during the study period.
11211377|NCT02271386|OG000|Outcome|Patients of Intervention Clinicians Completing MOC Attestation|Children aged 5-12 with ADHD seen by a clinician in the intervention group who fulfilled all requirements to receive Maintenance of Certification (MOC) credit.
11211378|NCT02271386|OG001|Outcome|Patients of Intervention Clinicians Not Completing MOC Attesta|Children aged 5-12 with ADHD seen by a clinician in the intervention group who did not fulfill all requirements to receive Maintenance of Certification (MOC) credit.
11211379|NCT02271386|OG000|Outcome|Patients of Intervention Clinicians Participating in >=1 Call|Children aged 5-12 with ADHD seen by a clinician in the intervention group who participated in at least one performance feedback call.
11211380|NCT02271386|OG001|Outcome|Patients of Intervention Clinicians Participating in 0 Calls|Children aged 5-12 with ADHD seen by a clinician in the intervention group who did not participate in at least one performance feedback call.
11211381|NCT02271386|OG000|Outcome|Intervention Clinicians|Clinicians in the intervention arm received the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.
11211382|NCT02271386|OG001|Outcome|Control Clinicians|Clinicians in the control arm received no intervention for the first 8 months of the study, then received the full SPA intervention for the last 8 months of the study.
11211383|NCT02271386|EG000|Reported Event|Intervention Clinicians|Clinicians in the intervention arm received the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.
11211384|NCT02271386|EG001|Reported Event|Control Clinicians|Clinicians in the control arm received no intervention for the first 8 months of the study, then received the full SPA intervention for the last 8 months of the study.
11211385|NCT02271386|EG002|Reported Event|Patients of Intervention Clinicians|Children aged 5-12 with ADHD seen by a clinician in the intervention group during the study period.
11211386|NCT02271386|EG003|Reported Event|Patients of Control Clinicians|Children aged 5-12 with an ADHD diagnosis seen by clinicians in the control group during the study period.
11211387|NCT02271425|BG000|Baseline|Evacetrapib Tablet + Evacetrapib Intravenous|Single oral dose of 130 mg evacetrapib tablet + a single IV dose of 175 µg [¹³C₈] evacetrapib administered over a 4 hour infusion.
11211388|NCT02271425|FG000|Participant Flow|Evacetrapib Tablet + Evacetrapib Intravenous|Single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)[¹³C₈] evacetrapib administered over a 4 hour infusion.
11211389|NCT02271425|OG000|Outcome|Evacetrapib: Tablet|A single oral dose of 130 mg evacetrapib tablet
11211390|NCT02271425|OG001|Outcome|Evacetrapib: Intravenous|A single IV dose of 175 μg [¹³C₈] evacetrapib administered over a 4 hour infusion.
11211391|NCT02271425|EG000|Reported Event|Evacetrapib Tablet + Evacetrapib Intravenous|Single oral dose of 130 mg evacetrapib tablet + a single IV dose of 175 µg [¹³C₈] evacetrapib administered over a 4 hour infusion.
11211392|NCT02271451|BG000|Baseline|Q Collar|"subjects wearing the q collar~Q collar: collar worn around neck"
11211393|NCT02271451|BG001|Baseline|Control|subjects not wearing the Q collar
11211394|NCT02271451|BG002|Baseline|Total|Total of all reporting groups
11211395|NCT02271451|FG000|Participant Flow|Q Collar|"subjects wearing the q collar~Q collar: collar worn around neck"
11211396|NCT02271451|FG001|Participant Flow|Control|subjects not wearing the Q collar
11211397|NCT02271451|OG000|Outcome|Q Collar|"subjects wearing the q collar~Q collar: collar worn around neck"
11211398|NCT02271451|OG001|Outcome|Control|subjects not wearing the Q collar
11211399|NCT02271451|EG000|Reported Event|Q Collar|"subjects wearing the q collar~Q collar: collar worn around neck"
11211400|NCT02271451|EG001|Reported Event|Control|subjects not wearing the Q collar
11211401|NCT02271477|BG000|Baseline|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
11211402|NCT02271477|BG001|Baseline|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
11211403|NCT02271477|BG002|Baseline|Total|Total of all reporting groups
11211404|NCT02271477|FG000|Participant Flow|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
11211405|NCT02271477|FG001|Participant Flow|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36%"
11211406|NCT02271477|OG000|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
11211407|NCT02271477|OG001|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
11211408|NCT02271477|OG001|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
11211409|NCT02271477|EG000|Reported Event|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
11211410|NCT02271477|EG001|Reported Event|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
11211411|NCT02271529|BG000|Baseline|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11211412|NCT02271529|FG000|Participant Flow|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11211413|NCT02271529|OG000|Outcome|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11211414|NCT02271529|EG000|Reported Event|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
11211415|NCT02271698|BG000|Baseline|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211416|NCT02271698|BG001|Baseline|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211417|NCT02271698|BG002|Baseline|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211418|NCT02271698|BG003|Baseline|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
11211419|NCT02271698|BG004|Baseline|Total|Total of all reporting groups
11211420|NCT02271698|FG000|Participant Flow|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211421|NCT02271698|FG001|Participant Flow|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211422|NCT02271698|FG002|Participant Flow|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211423|NCT02271698|FG003|Participant Flow|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
11211424|NCT02271698|OG000|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211425|NCT02271698|OG001|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211426|NCT02271698|OG002|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211427|NCT02271698|OG003|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
11211428|NCT02271698|EG000|Reported Event|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211429|NCT02271698|EG001|Reported Event|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211430|NCT02271698|EG002|Reported Event|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
11211431|NCT02271698|EG003|Reported Event|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
11211432|NCT02271854|BG000|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
11211433|NCT02271854|FG000|Participant Flow|Diclofenac Sodium Gel 1% and Placebo Gel|This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
11211434|NCT02271854|OG000|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
11211435|NCT02271854|OG001|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
11211436|NCT02271854|EG000|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
11211437|NCT02271880|BG000|Baseline|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
11211438|NCT02271880|BG001|Baseline|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211439|NCT02271880|BG002|Baseline|Total|Total of all reporting groups
11211440|NCT02271880|FG000|Participant Flow|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
11211441|NCT02271880|FG001|Participant Flow|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR (Supporting Teen Adherence and Responsibility): Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211442|NCT02271880|OG000|Outcome|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
11211443|NCT02271880|OG001|Outcome|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211444|NCT02271880|OG001|Outcome|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR (Supporting Teen Adherence and Responsibility): Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211445|NCT02271880|OG001|Outcome|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual: Physicians will prescribe medication as usual to the adolescent.~STAR: Adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211446|NCT02271880|EG000|Reported Event|Medication as Usual|"Medication as typically prescribed by physician.~Medication as usual: Physicians will prescribe medication as usual to the adolescent."
11211447|NCT02271880|EG001|Reported Event|Medication as Usual + STAR|"Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence~Medication as usual + STAR: Physicians will prescribe medication and adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals."
11211448|NCT02271906|BG000|Baseline|Afatinib Single Agent|Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
11211449|NCT02271906|FG000|Participant Flow|Afatinib Single Agent|Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
11211450|NCT02271906|OG000|Outcome|Afatinib Single Agent|Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
11211451|NCT02271906|EG000|Reported Event|Afatinib Single Agent|Afatinib 40mg orally daily until day of surgery for a minimum of two weeks
11211452|NCT02271945|BG000|Baseline|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211453|NCT02271945|BG001|Baseline|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211454|NCT02271945|BG002|Baseline|TOTAL|Total of all reporting groups
11211455|NCT02271945|FG000|Participant Flow|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211456|NCT02271945|FG001|Participant Flow|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211457|NCT02271945|OG000|Outcome|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211458|NCT02271945|OG001|Outcome|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211459|NCT02271945|EG000|Reported Event|MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211460|NCT02271945|EG001|Reported Event|MEDI-551 12 mg/kg and MEDI0680 10 mg/kg|Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
11211461|NCT02271984|BG000|Baseline|All Subjects|Subjects randomized to receive a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water, current praziquantel (PZQ) formulation (Cysticide®) at 40 mg/kg with water under fed conditions; MSC2499550A formulation at 10 mg/kg or 30 mg/kg dispersed in water under fed condition; MSC2499550A formulation at 20 mg/kg dispersed in water under fasted condition; MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed condition in one of the intervention periods.
11211462|NCT02271984|FG000|Participant Flow|ABC1DE|Subjects received a single oral dose of MSC2499550A oral disintegrating tablet (ODT) formulation at 20 milligram per kilogram (mg/kg) dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
11211463|NCT02271984|FG001|Participant Flow|ABDEC1|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period under fed condition followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
11286246|NCT02885506|BG007|Baseline|Pooled Placebo|"Placebo capsule oral administration~Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug."
11286247|NCT02885506|BG008|Baseline|Fed - Fasted|"A single oral dose of 250 mg of P218 under fed then fasted conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211464|NCT02271984|FG002|Participant Flow|ABEC1D|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
11211465|NCT02271984|FG003|Participant Flow|BAC1DE|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
11211466|NCT02271984|FG004|Participant Flow|BADEC1|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
11211467|NCT02271984|FG005|Participant Flow|BAEC1D|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water (C1) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
11211468|NCT02271984|FG006|Participant Flow|ABC2DE|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
11211469|NCT02271984|FG007|Participant Flow|ABDEC2|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
11211470|NCT02271984|FG008|Participant Flow|ABEC2D|Subjects received a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in first intervention period followed by single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fourth intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
11211471|NCT02271984|FG009|Participant Flow|BAC2DE|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in third intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fourth intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fifth intervention period under fed condition. There was a wash-out period of at least 7 days between each intervention period.
11211472|NCT02271984|FG010|Participant Flow|BADEC2|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in third intervention period under fasted conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in fourth intervention period followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fifth intervention period under fed conditions. There was a wash-out period of at least 7 days between each intervention period.
11211473|NCT02271984|FG011|Participant Flow|BAEC2D|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water (B) in first intervention period followed by a single oral dose of MSC2499550A ODT formulation at 20 mg/kg dispersed in water (A) in second intervention period followed by a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth (E) in third intervention followed by a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water (C2) in fourth intervention under fed conditions followed by a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water (D) in fifth intervention period under fasted conditions. There was a wash-out period of at least 7 days between each intervention period.
11211474|NCT02271984|OG000|Outcome|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
11211475|NCT02271984|OG001|Outcome|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
10819975|NCT00053014|FG000|Participant Flow|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
10819976|NCT00053014|OG000|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
10819977|NCT00053014|EG000|Reported Event|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
10819978|NCT00053352|BG000|Baseline|Arm I|Experimental
10819979|NCT00053352|BG001|Baseline|Arm 2|No intervention
10819980|NCT00053352|BG002|Baseline|Total|Total of all reporting groups
10819981|NCT00053352|FG000|Participant Flow|Arm I|Experimental
10819982|NCT00053352|FG001|Participant Flow|Arm 2|No intervention
10819983|NCT00053352|OG000|Outcome|Arm 1|Experimental
10819984|NCT00053352|OG000|Outcome|Arm I|Experimental
10819985|NCT00053352|OG001|Outcome|Arm 2|No intervention
11211476|NCT02271984|OG002|Outcome|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211477|NCT02271984|OG003|Outcome|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211478|NCT02271984|OG004|Outcome|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211479|NCT02271984|OG005|Outcome|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211480|NCT02271984|OG000|Outcome|Treatment A and B|Subjects received MSC2499550A formulation at 20 mg/kg dispersed in water as first or second intervention followed by current PZQ formulation (Cysticide®) at 40 mg/kg with water as second or first intervention under fed condition. There was a wash-out period of at least 7 days between each of the intervention period.
10819986|NCT00053352|EG000|Reported Event|Arm 2 (Observation)|"Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.~Observation only for recurrence or development of an SMN"
10819987|NCT00053352|EG001|Reported Event|Arm I (Chemotherapy)|"Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).~After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy.~After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.~Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, & 16.~con"
10819988|NCT00053365|BG000|Baseline|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
10819989|NCT00053365|FG000|Participant Flow|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
10819990|NCT00053365|OG000|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
10819991|NCT00053365|OG000|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
10819992|NCT00053365|OG001|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
10819993|NCT00053365|EG000|Reported Event|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
10819994|NCT00053417|BG000|Baseline|Placebo|Placebo control
10819995|NCT00053417|BG001|Baseline|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
11211481|NCT02271984|EG000|Reported Event|Treatment A|Subjects received a single oral dose of MSC2499550A formulation at 20 milligram per kilogram (mg/kg) dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each intervention period.
11211482|NCT02271984|EG001|Reported Event|Treatment B|Subjects received a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211483|NCT02271984|EG002|Reported Event|Treatment C1|Subjects received a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211484|NCT02271984|EG003|Reported Event|Treatment C2|Subjects received a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211485|NCT02271984|EG004|Reported Event|Treatment D|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211486|NCT02271984|EG005|Reported Event|Treatment E|Subjects received a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There was a wash-out period of at least 7 days between each of the intervention period.
11211487|NCT02272244|BG000|Baseline|Standard|"SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.~Standard"
11211488|NCT02272244|BG001|Baseline|Decision Support & Navigation|"DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.~Decision Support & Navigation"
11211489|NCT02272244|BG002|Baseline|Total|Total of all reporting groups
11211490|NCT02272244|FG000|Participant Flow|Standard|SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
11211491|NCT02272244|FG001|Participant Flow|Decision Support & Navigation|DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
11211492|NCT02272244|OG000|Outcome|Standard|SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
11211493|NCT02272244|OG001|Outcome|Decision Support & Navigation|DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
11211494|NCT02272244|EG000|Reported Event|Standard|"SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.~Standard"
11211495|NCT02272244|EG001|Reported Event|Decision Support & Navigation|"DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.~Decision Support & Navigation"
11211496|NCT02272413|BG000|Baseline|BI 695502|Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
11211497|NCT02272413|BG001|Baseline|Avastin® US|"Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 BSA, followed by carboplatin target AUC 6 mg/mL*min, with adequate pre- and concomitant medication.~After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier."
11211498|NCT02272413|BG002|Baseline|Total|Total of all reporting groups
11211499|NCT02272413|FG000|Participant Flow|BI 695502|Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
11211500|NCT02272413|FG001|Participant Flow|Avastin® US|"Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 BSA, followed by carboplatin target AUC 6 mg/mL*min, with adequate pre- and concomitant medication.~After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier."
11211501|NCT02272413|OG000|Outcome|BI 695502|Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
10819996|NCT00053417|BG002|Baseline|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
11211502|NCT02272413|OG001|Outcome|Avastin® US|"Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 BSA, followed by carboplatin target AUC 6 mg/mL*min, with adequate pre- and concomitant medication.~After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier."
11211503|NCT02272413|EG000|Reported Event|BI 695502 (Pre-switch)|Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 BSA, followed by carboplatin target AUC 6 mg/mL*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
10819997|NCT00053417|BG003|Baseline|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
10819998|NCT00053417|BG004|Baseline|Total|Total of all reporting groups
10819999|NCT00053417|FG000|Participant Flow|Placebo|Placebo control
10820000|NCT00053417|FG001|Participant Flow|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
10820001|NCT00053417|FG002|Participant Flow|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
11211504|NCT02272413|EG001|Reported Event|US-licensed Avastin® (Pre-switch)|"Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles.~During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m^2 BSA, followed by carboplatin target AUC 6 mg/mL*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier."
11211505|NCT02272413|EG002|Reported Event|BI 695502 (Post-switch)|Patients switched from BI 695502 to receive commercially available Avastin®.
11211506|NCT02272413|EG003|Reported Event|US-licensed Avastin® (Post-switch)|Patients switched from US-licensed Avastin® to receive commercially available Avastin®.
11211507|NCT02272634|BG000|Baseline|Treatment A|Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM
11211508|NCT02272634|BG001|Baseline|Treatment B|Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM
11211509|NCT02272634|BG002|Baseline|Treatment C|Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM
11211510|NCT02272634|BG003|Baseline|Total|Total of all reporting groups
11211511|NCT02272634|FG000|Participant Flow|YPL-001 Low Dose|Active arm including patients who receive the YPL-001 low dose. YPL-001 low dose: twice daily [BID]
11211512|NCT02272634|FG001|Participant Flow|YPL-001 High Dose|Active arm including patients who receive the YPL-001 high dose, YPL-001 high dose: twice daily [BID]
11211513|NCT02272634|FG002|Participant Flow|Placebo|Control arm including patients who receive the placebo drug. Placebo: twice daily [BID]
11211514|NCT02272634|OG000|Outcome|Treatment A|Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM
10820002|NCT00053417|FG003|Participant Flow|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
10820003|NCT00053417|OG000|Outcome|Placebo|Placebo control
10820004|NCT00053417|OG001|Outcome|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
10820005|NCT00053417|OG002|Outcome|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
11211515|NCT02272634|OG001|Outcome|Treatment B|Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM
11211516|NCT02272634|OG002|Outcome|Treatment C|Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM
11211517|NCT02272634|OG000|Outcome|Treatment A|Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55
11211518|NCT02272634|OG001|Outcome|Treatment B|Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55
11211519|NCT02272634|OG002|Outcome|Treatment C|Multiple oral doses of placebo BID on Days 1 - 55
11211520|NCT02272634|EG000|Reported Event|Treatment A|Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55
11211521|NCT02272634|EG001|Reported Event|Treatment B|Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55
11211522|NCT02272634|EG002|Reported Event|Treatment C|Multiple oral doses of placebo BID on Days 1 - 55
11211523|NCT02272686|BG000|Baseline|Ibrutinib Maintenance|Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
11211524|NCT02272686|FG000|Participant Flow|Ibrutinib Maintenance|Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
11211525|NCT02272686|OG000|Outcome|Ibrutinib Maintenance|Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
11211526|NCT02272686|EG000|Reported Event|Ibrutinib Maintenance|Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
11211527|NCT02272725|BG000|Baseline|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
11211528|NCT02272725|BG001|Baseline|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
11211529|NCT02272725|BG002|Baseline|Total|Total of all reporting groups
10820006|NCT00053417|OG003|Outcome|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
11211530|NCT02272725|FG000|Participant Flow|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
11211531|NCT02272725|FG001|Participant Flow|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
11211532|NCT02272725|OG000|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
11211533|NCT02272725|OG001|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
11211534|NCT02272725|EG000|Reported Event|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
11211535|NCT02272725|EG001|Reported Event|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
11211536|NCT02272777|BG000|Baseline|Imatinib|Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
11211537|NCT02272777|BG001|Baseline|Nilotinib|Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
11211538|NCT02272777|BG002|Baseline|Total|Total of all reporting groups
11211539|NCT02272777|FG000|Participant Flow|Imatinib|Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
11211540|NCT02272777|FG001|Participant Flow|Nilotinib|Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
11211541|NCT02272777|OG000|Outcome|Imatinib|Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
11211542|NCT02272777|OG001|Outcome|Nilotinib|Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
11211543|NCT02272777|EG000|Reported Event|Imatinib|Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
11211544|NCT02272777|EG001|Reported Event|Nilotinib|Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
11211545|NCT02272816|BG000|Baseline|Carboplatin AUC-10|Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
11211546|NCT02272816|FG000|Participant Flow|Carboplatin AUC-10|Carboplatin area under the curve (AUC)-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
11211547|NCT02272816|OG000|Outcome|Carboplatin AUC-10|Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
11211548|NCT02272816|EG000|Reported Event|Carboplatin AUC-10|Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
11211549|NCT02272842|BG000|Baseline|Vitamin B12|"A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India)~Vitamin B12: Vitamin B12 in a multivitamin paste."
11211550|NCT02272842|BG001|Baseline|Placebo|"A paste containing no vitamin B12 administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)~Placebo B12: Placebo B12 in a multivitamin paste."
11211551|NCT02272842|BG002|Baseline|Total|Total of all reporting groups
11211552|NCT02272842|FG000|Participant Flow|Vitamin B12|"A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India)~Vitamin B12: Vitamin B12 in a multivitamin paste."
11211553|NCT02272842|FG001|Participant Flow|Placebo|"A paste containing no vitamin B12 administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)~Placebo B12: Placebo B12 in a multivitamin paste."
11211554|NCT02272842|OG000|Outcome|Vitamin B12|"A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India)~Vitamin B12: Vitamin B12 in a multivitamin paste."
11211555|NCT02272842|OG001|Outcome|Placebo|"A paste containing no vitamin B12 administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)~Placebo B12: Placebo B12 in a multivitamin paste."
11211556|NCT02272842|OG001|Outcome|Placebo|"A paste containing no vitamin administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)~Vitamin B12: Vitamin B12 in a multivitamin paste."
11211557|NCT02272842|EG000|Reported Event|Vitamin B12|"A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India)~Vitamin B12: Vitamin B12 in a multivitamin paste."
11211558|NCT02272842|EG001|Reported Event|Placebo|"A paste containing no vitamin B12 administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)~Placebo B12: Placebo B12 in a multivitamin paste."
11211559|NCT02272985|BG000|Baseline|CBF Change During HD|Arm/Group is not applicable.
11211560|NCT02272985|FG000|Participant Flow|CBF Change|Hemodialysis patients that underwent 3 PET-scans during a hemodialysis study-session.
11211561|NCT02272985|OG000|Outcome|Global CBF Change During HD|All patients (n=12)
11211562|NCT02272985|OG000|Outcome|rSO2 Change During Hemodialysis|"[15O]H2O PET-CT scan and NIRS (Invos)~[15O]H2O PET-CT scan: All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session~NIRS (Invos): All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session."
11211563|NCT02272985|EG000|Reported Event|CBF Change During HD|
11211564|NCT02273037|BG000|Baseline|Pinard|Pinard
11211565|NCT02273037|BG001|Baseline|Doppler|Doppler
11211566|NCT02273037|BG002|Baseline|Total|Total of all reporting groups
11211567|NCT02273037|FG000|Participant Flow|Pinard|Pinard Auscultation (standard of care)
11211568|NCT02273037|FG001|Participant Flow|Doppler|Doppler Auscultation (Intervention)
11211569|NCT02273037|OG000|Outcome|Pinard Horn|"Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study.~Partograph: Graphical documentation of labour progress, and maternal and fetal well-being."
11211570|NCT02273037|OG001|Outcome|Fetal Heart Rate Doppler|"Doppler used to monitor the fetal heart rate in labour in this arm of the study.~Fetal heart rate Doppler: A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za)~Partograph: Graphical documentation of labour progress, and maternal and fetal well-being."
11211571|NCT02273037|OG000|Outcome|Pinard|Pinard Auscultation (standard of care)
11211572|NCT02273037|OG001|Outcome|Doppler|Doppler Auscultation (Intervention)
11211573|NCT02273037|EG000|Reported Event|Pinard|Pinard Auscultation (standard of care)
11211574|NCT02273037|EG001|Reported Event|Doppler|Doppler Auscultation (Intervention)
11211575|NCT02273050|BG000|Baseline|METFORMIN + PLACEBO 5MG QD|
11211576|NCT02273050|BG001|Baseline|SAXAGLIPTIN 5MG QD + METFORMIN|
11211577|NCT02273050|BG002|Baseline|SAXAGLIPTIN 5MG QD + PLACEBO|
11211578|NCT02273050|BG003|Baseline|Total|Total of all reporting groups
11211579|NCT02273050|FG000|Participant Flow|METFORMIN + PLACEBO 5MG QD|
11211580|NCT02273050|FG001|Participant Flow|SAXAGLIPTIN 5MG QD + METFORMIN|
11211581|NCT02273050|FG002|Participant Flow|SAXAGLIPTIN 5MG QD + PLACEBO|
11211582|NCT02273050|OG000|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg + Metformin 500 mg
11211583|NCT02273050|OG001|Outcome|Saxagliptin + Placebo|Saxagliptin 5 mg + Placebo
11211584|NCT02273050|OG002|Outcome|Metformin + Placebo|Metformin 500 mg + Placebo
11211585|NCT02273050|EG000|Reported Event|METFORMIN + PLACEBO 5MG QD|
11211586|NCT02273050|EG001|Reported Event|SAXAGLIPTIN 5MG QD + METFORMIN|
11211587|NCT02273050|EG002|Reported Event|SAXAGLIPTIN 5MG QD + PLACEBO|
11211588|NCT02273063|BG000|Baseline|TMS Prescription|"5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000~Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment."
11211589|NCT02273063|FG000|Participant Flow|TMS Prescription|"5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000~Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment."
11211590|NCT02273063|OG000|Outcome|Transcranial Magnetic Stimulation (TMS)|"TMS 5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000~Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment."
11211591|NCT02273063|OG000|Outcome|TMS Prescription|"5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000~Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment."
11211592|NCT02273063|EG000|Reported Event|TMS Prescription|"5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000~Transcranial Magnetic Stimulation: Stimulating DLPFC at 5 Hz for up to 40 treatment sessions overall. 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper over 3 weeks. There will be a post treatment assessment 72 hours after final treatment, and then again 1 month after the final treatment."
11211593|NCT02273115|BG000|Baseline|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211594|NCT02273115|BG001|Baseline|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211595|NCT02273115|BG002|Baseline|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211596|NCT02273115|BG003|Baseline|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211597|NCT02273115|BG004|Baseline|Total|Total of all reporting groups
10820007|NCT00053417|EG000|Reported Event|Placebo|Placebo control
11286248|NCT02885506|BG009|Baseline|Fasted - Fed|"A single oral dose of 250 mg of P218 under fasted then fed conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286249|NCT02885506|BG010|Baseline|Total|Total of all reporting groups
11286250|NCT02885506|FG000|Participant Flow|Cohort 1|"10 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286251|NCT02885506|FG001|Participant Flow|Cohort 2|"30 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10820008|NCT00053417|EG001|Reported Event|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
10820009|NCT00053417|EG002|Reported Event|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
10820010|NCT00053417|EG003|Reported Event|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
11211598|NCT02273115|FG000|Participant Flow|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211599|NCT02273115|FG001|Participant Flow|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211600|NCT02273115|FG002|Participant Flow|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211601|NCT02273115|FG003|Participant Flow|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211602|NCT02273115|OG000|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211603|NCT02273115|OG001|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211604|NCT02273115|OG002|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211605|NCT02273115|OG003|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211606|NCT02273115|EG000|Reported Event|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11286252|NCT02885506|FG002|Participant Flow|Cohort 3|"100 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10820011|NCT00053482|BG000|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
10820012|NCT00053482|BG001|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
11211607|NCT02273115|EG001|Reported Event|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211608|NCT02273115|EG002|Reported Event|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
11211609|NCT02273115|EG003|Reported Event|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
11211610|NCT02273141|BG000|Baseline|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the moring of the day before colonoscopy).
11211611|NCT02273141|BG001|Baseline|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
11211612|NCT02273141|BG002|Baseline|Total|Total of all reporting groups
11211613|NCT02273141|FG000|Participant Flow|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
11211614|NCT02273141|FG001|Participant Flow|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
11211615|NCT02273141|OG000|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
11211616|NCT02273141|OG001|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
10820013|NCT00053482|BG002|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
11211617|NCT02273141|EG000|Reported Event|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
11211618|NCT02273141|EG001|Reported Event|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
11211619|NCT02273167|BG000|Baseline|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211620|NCT02273167|BG001|Baseline|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211621|NCT02273167|BG002|Baseline|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
11211622|NCT02273167|BG003|Baseline|Total|Total of all reporting groups
11211623|NCT02273167|FG000|Participant Flow|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211624|NCT02273167|FG001|Participant Flow|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211625|NCT02273167|FG002|Participant Flow|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
11211626|NCT02273167|OG000|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211627|NCT02273167|OG001|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211628|NCT02273167|OG002|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
11211629|NCT02273167|OG000|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211630|NCT02273167|EG000|Reported Event|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211631|NCT02273167|EG001|Reported Event|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
11211632|NCT02273167|EG002|Reported Event|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
11211633|NCT02273180|BG000|Baseline|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211634|NCT02273180|BG001|Baseline|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
10820014|NCT00053482|BG003|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
11211635|NCT02273180|BG002|Baseline|Total|Total of all reporting groups
11211636|NCT02273180|FG000|Participant Flow|SAR342434|SAR342434 100 Units(U)/mL subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
11211637|NCT02273180|FG001|Participant Flow|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211638|NCT02273180|OG000|Outcome|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211639|NCT02273180|OG001|Outcome|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211640|NCT02273180|EG000|Reported Event|SAR342434|SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211641|NCT02273180|EG001|Reported Event|Humalog|Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
11211642|NCT02273206|BG000|Baseline|Collaborative Care Intervention (CCI)|Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services.
11211643|NCT02273206|BG001|Baseline|Prevention Care Management (PCM) Intervention|The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening.
11211644|NCT02273206|BG002|Baseline|Total|Total of all reporting groups
11211645|NCT02273206|FG000|Participant Flow|Collaborative Care Intervention (CCI)|Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services.
11211646|NCT02273206|FG001|Participant Flow|Prevention Care Management (PCM) Intervention|The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening.
10820015|NCT00053482|BG004|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
10820016|NCT00053482|BG005|Baseline|Total|Total of all reporting groups
11211647|NCT02273206|OG000|Outcome|Collaborative Care Intervention (CCI)|Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services
11211648|NCT02273206|OG001|Outcome|Prevention Care Management (PCM)|The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening
11211649|NCT02273206|EG000|Reported Event|Collaborative Care Intervention (CCI)|Participants assigned to the CCI group received the Prevention Care Management (PCM) intervention, as well as motivational support to initiate or follow up on mental health treatment and linkages to social support services
11211650|NCT02273206|EG001|Reported Event|Prevention Care Management (PCM) Intervention|The PCM intervention consisted of cancer screening telephone support, including education, patient navigation, and motivational interviewing to overcome barriers to screening
11211651|NCT02273310|BG000|Baseline|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
11211652|NCT02273310|BG001|Baseline|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
11211653|NCT02273310|BG002|Baseline|Total|Total of all reporting groups
11211654|NCT02273310|FG000|Participant Flow|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
11211655|NCT02273310|FG001|Participant Flow|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
11211656|NCT02273310|OG000|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
11211657|NCT02273310|OG001|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
11211658|NCT02273310|OG000|Outcome|Families Taking Control|"Families participate in a 1 day Problem-Solving Skills training for disease management intervention~Problem-Solving Skills Training for Disease Management: Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease."
11211659|NCT02273310|EG000|Reported Event|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
11211660|NCT02273310|EG001|Reported Event|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
11211661|NCT02273323|BG000|Baseline|All Study Participants|Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
11211662|NCT02273323|FG000|Participant Flow|Tea Then Placebo|Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
10820017|NCT00053482|FG000|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
11211663|NCT02273323|FG001|Participant Flow|Placebo Then Tea|Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
11211664|NCT02273323|OG000|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
11211665|NCT02273323|OG001|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
11211666|NCT02273323|EG000|Reported Event|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
11211667|NCT02273323|EG001|Reported Event|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
11286253|NCT02885506|FG003|Participant Flow|Cohort 4|"250 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286254|NCT02885506|FG004|Participant Flow|Cohort 5|"500 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211668|NCT02273596|BG000|Baseline|ALXN1840|"Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 mg per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.~Extension Period: Participants continued the same ALXN1840 daily dose maintained at Week 24 of the Treatment Period and the same dosing regimen. During the Extension Period, no up-titration was made unless NCC concentrations adjusted for Mo plasma concentration did not remain stable within (or below) the reference range."
11211669|NCT02273596|FG000|Participant Flow|ALXN1840|"Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 milligrams (mg) per day. Dose increases or dose reductions were dependent on the individual non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum (Mo) plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.~Extension Period: Participants continued the same ALXN1840 daily dose maintained at Week 24 of the Treatment Period and the same dosing regimen. During the Extension Period, no up-titration was made unless NCC concentrations adjusted for Mo plasma concentration did not remain stable within (or below) the reference range."
11211670|NCT02273596|OG000|Outcome|ALXN1840|Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 mg per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.
11211671|NCT02273596|OG000|Outcome|ALXN1840|"Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 mg per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.~Extension Period: Participants continued the same ALXN1840 daily dose maintained at Week 24 of the Treatment Period and the same dosing regimen. During the Extension Period, no up-titration was made unless NCC concentrations adjusted for Mo plasma concentration did not remain stable within (or below) the reference range."
11211672|NCT02273596|OG000|Outcome|ALXN1840|Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 milligram (mg) per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.
11211673|NCT02273596|OG000|Outcome|ALXN1840 Every Other Day|ALXN1840 administered at 15 mg every other day.
11211674|NCT02273596|OG001|Outcome|ALXN1840 15 mg Daily|ALXN1840 administered at 15 mg per day.
11211675|NCT02273596|OG002|Outcome|ALXN1840 30 mg Daily|ALXN1840 administered at 30 mg per day.
11211676|NCT02273596|OG003|Outcome|ALXN1840 60 mg Daily|ALXN1840 administered at 60 mg per day (or 30 mg twice daily).
11211677|NCT02273596|EG000|Reported Event|ALXN1840|"Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 mg per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.~Extension Period: Participants continued the same ALXN1840 daily dose maintained at Week 24 of the Treatment Period and the same dosing regimen. During the Extension Period, no up-titration was made unless NCC concentrations adjusted for Mo plasma concentration did not remain stable within (or below) the reference range."
11211678|NCT02273726|BG000|Baseline|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on the participant's average prescribed ESA dose in the 4 weeks (if on epoetin or darbepoetin or 8 weeks (if on Mircera®) prior to randomization. Dose adjustments were permitted to maintain a Hb level of approximately 11 g/dL. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 183.7 weeks.
11211679|NCT02273726|BG001|Baseline|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW and participants on home HD or PD received epoetin alfa, administered SC. Initial epoetin alfa dose was based on the participant's average weekly prescribed ESA dose in 4 weeks prior to randomization if on epoetin or darbepoetin, and average monthly (4-week) prescribed ESA dose in 8 weeks prior to randomization if on Mircera®. In case of a change in route of administration from SC to IV (TIW), the initial dose of IV epoetin alfa was determined by the investigator per local SOC. Dose adjustments followed the recommendations as per the approved country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 180.4 weeks.
11211680|NCT02273726|BG002|Baseline|Total|Total of all reporting groups
11286255|NCT02885506|FG005|Participant Flow|Cohort 6|"750 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286256|NCT02885506|FG006|Participant Flow|Cohort 7|"1000 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11211681|NCT02273726|FG000|Participant Flow|Roxadustat|Participants received roxadustat tablets, administered orally 3 times weekly (TIW). Initial roxadustat dose was based on the participant's average prescribed erythropoietin stimulating agent (ESA) dose in the 4 weeks (if on epoetin or darbepoetin or 8 weeks (if on Mircera®) prior to randomization. Dose adjustments were permitted to maintain a hemoglobin (Hb) level of approximately 11 grams (g)/deciliter (dL). The maximum roxadustat dose was 3.0 milligrams (mg)/kilogram (kg) per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 183.7 weeks.
11211682|NCT02273726|FG001|Participant Flow|Epoetin Alfa|Participants on hemodialysis (HD) received epoetin alfa, administered intravenously (IV) TIW and participants on home HD or peritoneal dialysis (PD) received epoetin alfa, administered subcutaneously (SC). Initial epoetin alfa dose was based on the participant's average weekly prescribed ESA dose in 4 weeks prior to randomization if on epoetin or darbepoetin, and average monthly (4-week) prescribed ESA dose in 8 weeks prior to randomization if on Mircera®. In case of a change in route of administration from SC to IV (TIW), the initial dose of IV epoetin alfa was determined by the investigator per local standard of care (SOC). Dose adjustments followed the recommendations as per the approved country-specific product label (United States Package Insert [USPI] or Summary of Product Characteristics [SmPC]) or local SOC. The maximum treatment duration was 180.4 weeks.
11211683|NCT02273726|OG000|Outcome|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on the participant's average prescribed ESA dose in the 4 weeks (if on epoetin or darbepoetin or 8 weeks (if on Mircera®) prior to randomization. Dose adjustments were permitted to maintain a Hb level of approximately 11 g/dL. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 183.7 weeks.
11211684|NCT02273726|OG001|Outcome|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW and participants on home HD or PD received epoetin alfa, administered SC. Initial epoetin alfa dose was based on the participant's average weekly prescribed ESA dose in 4 weeks prior to randomization if on epoetin or darbepoetin, and average monthly (4-week) prescribed ESA dose in 8 weeks prior to randomization if on Mircera®. In case of a change in route of administration from SC to IV (TIW), the initial dose of IV epoetin alfa was determined by the investigator per local SOC. Dose adjustments followed the recommendations as per the approved country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 180.4 weeks.
11211685|NCT02273726|EG000|Reported Event|Roxadustat|Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on the participant's average prescribed ESA dose in the 4 weeks (if on epoetin or darbepoetin or 8 weeks (if on Mircera®) prior to randomization. Dose adjustments were permitted to maintain a Hb level of approximately 11 g/dL. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 183.7 weeks.
11211686|NCT02273726|EG001|Reported Event|Epoetin Alfa|Participants on HD received epoetin alfa, administered IV TIW and participants on home HD or PD received epoetin alfa, administered SC. Initial epoetin alfa dose was based on the participant's average weekly prescribed ESA dose in 4 weeks prior to randomization if on epoetin or darbepoetin, and average monthly (4-week) prescribed ESA dose in 8 weeks prior to randomization if on Mircera®. In case of a change in route of administration from SC to IV (TIW), the initial dose of IV epoetin alfa was determined by the investigator per local SOC. Dose adjustments followed the recommendations as per the approved country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 180.4 weeks.
11211687|NCT02273739|BG000|Baseline|Enasidenib 100 mg|Participants received enasidenib 100 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211688|NCT02273739|BG001|Baseline|Enasidenib 200 mg|Participants received enasidenib 200 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211689|NCT02273739|BG002|Baseline|Enasidenib 400 mg|Participants received enasidenib 400 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211690|NCT02273739|BG003|Baseline|Enasidenib 650 mg|Participants received enasidenib 650 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211691|NCT02273739|BG004|Baseline|Total|Total of all reporting groups
11211692|NCT02273739|FG000|Participant Flow|Enasidenib 100 mg|Participants received enasidenib 100 mg tablets once a day (QD) on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211693|NCT02273739|FG001|Participant Flow|Enasidenib 200 mg|Participants received enasidenib 200 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211694|NCT02273739|FG002|Participant Flow|Enasidenib 400 mg|Participants received enasidenib 400 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211695|NCT02273739|FG003|Participant Flow|Enasidenib 650 mg|Participants received enasidenib 650 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211696|NCT02273739|OG000|Outcome|Enasidenib 100 mg|Participants received enasidenib 100 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211697|NCT02273739|OG001|Outcome|Enasidenib 200 mg|Participants received enasidenib 200 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211698|NCT02273739|OG002|Outcome|Enasidenib 400 mg|Participants received enasidenib 400 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211699|NCT02273739|OG003|Outcome|Enasidenib 650 mg|Participants received enasidenib 650 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211700|NCT02273739|OG000|Outcome|Enasidenib 100 mg|Participants received a single oral dose of enasidenib 100 mg on Day -3.
11211701|NCT02273739|OG001|Outcome|Enasidenib 200 mg|Participants received a single oral dose of enasidenib 200 mg on Day -3.
11211702|NCT02273739|OG002|Outcome|Enasidenib 400 mg|Participants received a single oral dose of enasidenib 400 mg on Day -3.
11211703|NCT02273739|OG003|Outcome|Enasidenib 650 mg|Participants received a single oral dose of enasidenib 650 mg on Day -3.
10820018|NCT00053482|FG001|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
11211704|NCT02273739|OG002|Outcome|Enasidenb 400 mg|Participants received enasidenib 400 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211705|NCT02273739|EG000|Reported Event|Enasidenib 100 mg|Participants received enasidenib 100 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211706|NCT02273739|EG001|Reported Event|Enasidenib 200 mg|Participants received enasidenib 200 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211707|NCT02273739|EG002|Reported Event|Enasidenib 400 mg|Participants received enasidenib 400 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211708|NCT02273739|EG003|Reported Event|Enasidenib 650 mg|Participants received enasidenib 650 mg tablets QD on Days 1 to 28 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
11211709|NCT02273908|BG000|Baseline|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
11211710|NCT02273908|BG001|Baseline|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
11211711|NCT02273908|BG002|Baseline|Total|Total of all reporting groups
11211712|NCT02273908|FG000|Participant Flow|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
11211713|NCT02273908|FG001|Participant Flow|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
11211714|NCT02273908|OG000|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
11211715|NCT02273908|OG001|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
11211716|NCT02273908|OG001|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
11211717|NCT02273908|OG000|Outcome|Pregabalin|1.Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
10820019|NCT00053482|FG002|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
10820020|NCT00053482|FG003|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
11211718|NCT02273908|OG001|Outcome|Other Analgesics|2.Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
11211719|NCT02273908|OG001|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care : no intervention
11211720|NCT02273908|OG000|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care : No intervention
10820021|NCT00053482|FG004|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
10820022|NCT00053482|OG000|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
10820023|NCT00053482|OG001|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
11211721|NCT02273908|EG000|Reported Event|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
11211722|NCT02273960|BG000|Baseline|BMS 75 mg|BMS-986004 dose level 75 mg
11211723|NCT02273960|BG001|Baseline|BMS-986004 225mg IV|BMS-986004 dose level 225 mg
11211724|NCT02273960|BG002|Baseline|BMS 675mg|BMS-986004 dose level 675 mg
11211725|NCT02273960|BG003|Baseline|BMS 1500mg|BMS-986004 dose level 1500 mg
11211726|NCT02273960|BG004|Baseline|Total|Total of all reporting groups
11211727|NCT02273960|FG000|Participant Flow|BMS-986004 75mg IV|BMS-986004 dose level 75 mg
11211728|NCT02273960|FG001|Participant Flow|BMS-986004 225mg IV|BMS-986004 dose level 225 mg
11211729|NCT02273960|FG002|Participant Flow|BMS-986004 675 mg IV|BMS-986004 dose level 675 mg
11211730|NCT02273960|FG003|Participant Flow|BM-986004 1500 mg IV|BMS-986004 dose level 1500 mg
11211731|NCT02273960|OG000|Outcome|BMS 75 mg|BMS-986004 dose level 75 mg
11211732|NCT02273960|OG001|Outcome|BMS 225 mg|BMS-986004 dose level 225 mg
11211733|NCT02273960|OG002|Outcome|BMS-986004 675 mg IV|BMS-986004 dose level 675 mg
11211734|NCT02273960|OG003|Outcome|BMS 1500mg|BMS-986004 dose level 1500 mg
11211735|NCT02273960|EG000|Reported Event|BMS-986004 75mg IV|BMS-986004 dose level 75 mg
11211736|NCT02273960|EG001|Reported Event|BMS-986004 225mg IV|BMS-986004 dose level 225 mg
11211737|NCT02273960|EG002|Reported Event|BMS 675mg|BMS-986004 dose level 675 mg
11211738|NCT02273960|EG003|Reported Event|BMS 1500mg|BMS-986004 dose level 1500 mg
11211739|NCT02273973|BG000|Baseline|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
11211740|NCT02273973|BG001|Baseline|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
11211741|NCT02273973|BG002|Baseline|Total|Total of all reporting groups
11211742|NCT02273973|FG000|Participant Flow|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
11211743|NCT02273973|FG001|Participant Flow|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
11211744|NCT02273973|OG000|Outcome|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
11211745|NCT02273973|OG001|Outcome|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
11244424|NCT02511236|BG000|Baseline|Group Cognitive Behavioral Therapy|"Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~Group Cognitive Behavioral Therapy: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244425|NCT02511236|BG001|Baseline|General Health Education|"Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~General Health Education: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244426|NCT02511236|BG002|Baseline|Total|Total of all reporting groups
11244427|NCT02511236|FG000|Participant Flow|Group Cognitive Behavioral Therapy|"Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~Group Cognitive Behavioral Therapy: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244428|NCT02511236|FG001|Participant Flow|General Health Education|"Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~General Health Education: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244429|NCT02511236|OG000|Outcome|Group Cognitive Behavioral Therapy|"Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~Group Cognitive Behavioral Therapy: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244430|NCT02511236|OG001|Outcome|General Health Education|"Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~General Health Education: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11286257|NCT02885506|FG007|Participant Flow|Pooled Placebo|"Placebo capsule oral administration~Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug."
11211746|NCT02273973|EG000|Reported Event|Experimental: Taselisib + Letrozole|Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
11211747|NCT02273973|EG001|Reported Event|Placebo Comparator: Placebo + Letrozole|Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
11211748|NCT02274038|BG000|Baseline|18F-thymidine (FLT) PET/CT|"All patients enrolled in the study will receive three 18F-thymidine (FLT) PET/CT scans at the following timepoints: before therapy, on the day of starting pemetrexed therapy (within 24 hours of starting pemetrexed) and at 2-4 weeks of starting pemetrexed therapy.~Baseline 18F-thymidine (FLT) PET/CT: FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This baseline scan will be used to compare post-therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT flare: This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT flare.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation: This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation."
11211749|NCT02274038|FG000|Participant Flow|18F-thymidine (FLT) PET/CT|"All patients enrolled receive three 18F-thymidine (FLT) PET/CT scans at the following timepoints: before therapy, on the day of starting pemetrexed therapy (within 24 hours of starting pemetrexed) and at 2-4 weeks of starting pemetrexed therapy.~Baseline 18F-thymidine (FLT) PET/CT: FLT is a fluoro-labelled thymidine analog and radiotracer of tumor proliferation in PET/CT imaging. This baseline scan will be used to compare post-therapy FLT-PET/CT to assess change in tumor accumulation of FLT.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT flare: This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT flare.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation: This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation."
11211750|NCT02274038|OG000|Outcome|18F-thymidine (FLT) PET/CT|"All patients enrolled in the study will receive three 18F-thymidine (FLT) PET/CT scans at the following timepoints: before therapy, on the day of starting pemetrexed therapy (within 24 hours of starting pemetrexed) and at 2-4 weeks of starting pemetrexed therapy.~Baseline 18F-thymidine (FLT) PET/CT: FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This baseline scan will be used to compare post-therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT flare: This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT flare.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation: This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation."
11211751|NCT02274038|OG000|Outcome|18F-thymidine (FLT) PET/CT|based on poor recruitment efforts subjects were unable to be analyzed
11211752|NCT02274038|OG000|Outcome|18F-thymidine (FLT) PET/CT|overall survival
11211753|NCT02274038|EG000|Reported Event|Baseline 18F-thymidine PET/CT (FLT-PET/CT)|"All patients enrolled in the study will receive three 18F-thymidine (FLT) PET/CT scans at the following timepoints: before therapy, on the day of starting pemetrexed therapy (within 24 hours of starting pemetrexed) and at 2-4 weeks of starting pemetrexed therapy.~Baseline 18F-thymidine (FLT) PET/CT: This baseline scan will be used to compare post-therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT flare: This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT flare.~Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation: This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation."
11211754|NCT02274311|BG000|Baseline|Clomiphene Citrate|"Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months~Patients with active acromegaly, defined by high IGF-1 levels, on regular use of a stable dose of Octreotide-LAR and/or Cabergoline for at least 1 year; IGF-1 above the reference range during the last year of follow-up; and T levels within or below the third inferior tertile of normality."
11211755|NCT02274311|FG000|Participant Flow|Clomiphene Citrate|"Patients receiving clomiphene citrate~Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months~16 patients were enrolled"
11211756|NCT02274311|OG000|Outcome|Clomiphene Citrate|"Patients receiving clomiphene citrate~Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months~16 patients were enrolled.~IGF-1 values were assessed at D0 (baseline) and D90 (mean values)"
11211757|NCT02274311|OG000|Outcome|Clomiphene Citrate|Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled.
11211758|NCT02274311|OG000|Outcome|Clomiphene Citrate|"Patients receiving clomiphene citrate~Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months~16 patients were enrolled."
11211759|NCT02274311|EG000|Reported Event|Clomiphene Citrate|"Patients receiving clomiphene citrate~Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months~No adverse events were reported"
11211760|NCT02274493|BG000|Baseline|Latissimus Dorsi Muscle Harvest|Latissimus dorsi muscle harvest using the DaVinci robotic approach
11211761|NCT02274493|FG000|Participant Flow|Latissimus Dorsi Muscle Harvest|Latissimus dorsi muscle harvest using the DaVinci robotic approach
11211762|NCT02274493|OG000|Outcome|Latissimus Dorsi Muscle Harvest|Latissimus dorsi muscle harvest using the DaVinci robotic approach
11211763|NCT02274493|EG000|Reported Event|Latissimus Dorsi Muscle Harvest|Latissimus dorsi muscle harvest using the DaVinci robotic approach
11211764|NCT02274558|BG000|Baseline|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
11211765|NCT02274558|BG001|Baseline|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
11211766|NCT02274558|BG002|Baseline|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
11211767|NCT02274558|BG003|Baseline|Total|Total of all reporting groups
11211768|NCT02274558|FG000|Participant Flow|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
11211769|NCT02274558|FG001|Participant Flow|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
11211770|NCT02274558|FG002|Participant Flow|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
11211771|NCT02274558|OG000|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
11211772|NCT02274558|OG001|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
11211773|NCT02274558|OG002|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
11211774|NCT02274558|OG001|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
11211775|NCT02274558|OG002|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
11211776|NCT02274558|EG000|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
11211777|NCT02274558|EG001|Reported Event|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
11211778|NCT02274558|EG002|Reported Event|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
11211779|NCT02274649|BG000|Baseline|Intervention|Intervention group receiving one-to-one peer mentoring. Each patient received 1 hour (approximate) of one-to-one peer mentoring each week during rehabilitation and telephone contact each week for 90 days post discharge
11211780|NCT02274649|BG001|Baseline|Control|Control group receiving traditional peer support services, which includes introduction of peer support and provision of support services upon request
11211781|NCT02274649|BG002|Baseline|Total|Total of all reporting groups
11211782|NCT02274649|FG000|Participant Flow|Intervention|Intervention group receiving one-to-one peer mentoring. Each patient received 1 hour (approximate) of one-to-one peer mentoring each week during rehabilitation and telephone contact each week for 90 days post discharge
11211783|NCT02274649|FG001|Participant Flow|Control|Control group receiving traditional peer support services, which includesintroduction of peer support and provision of support services upon request
11211784|NCT02274649|OG000|Outcome|Control|"Control group receiving general peer support~general peer support: General (traditional) peer support includes introduction and provision of support services upon request"
11211785|NCT02274649|OG001|Outcome|Intervention|"Intervention group receiving one-to-one peer mentoring~one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge"
11211786|NCT02274649|EG000|Reported Event|Intervention|Intervention group receiving one-to-one peer mentoring. Each patient received 1 hour (approximate) of one-to-one peer mentoring each week during rehabilitation and telephone contact each week for 90 days post discharge
11211787|NCT02274649|EG001|Reported Event|Control|Control group receiving traditional peer support services, which includes introduction of peer support and provision of support services upon request
11211788|NCT02274675|BG000|Baseline|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
11211789|NCT02274675|FG000|Participant Flow|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
11211790|NCT02274675|OG000|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
11211791|NCT02274675|EG000|Reported Event|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
11211792|NCT02274688|BG000|Baseline|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
11211793|NCT02274688|BG001|Baseline|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
11211794|NCT02274688|BG002|Baseline|Total|Total of all reporting groups
11211795|NCT02274688|FG000|Participant Flow|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
11211796|NCT02274688|FG001|Participant Flow|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
11211797|NCT02274688|OG000|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
11211798|NCT02274688|OG001|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
11211799|NCT02274688|OG001|Outcome|Patient-centered Care Transition|"Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Stepped Care Management: Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements."
11211800|NCT02274688|EG000|Reported Event|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.~Will be blindly assessed."
11211801|NCT02274688|EG001|Reported Event|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.~Will be blindly assessed."
11211802|NCT02274766|BG000|Baseline|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
11211803|NCT02274766|BG001|Baseline|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
11211804|NCT02274766|BG002|Baseline|Total|Total of all reporting groups
11211805|NCT02274766|FG000|Participant Flow|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
11211806|NCT02274766|FG001|Participant Flow|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 13 weeks
11211807|NCT02274766|OG000|Outcome|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
11211808|NCT02274766|OG001|Outcome|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
11211809|NCT02274766|EG000|Reported Event|Placebo|Placebo: oral capsules administered once nightly at bedtime for 13 weeks
11211810|NCT02274766|EG001|Reported Event|ADS-5102 (Amantadine HCl Extended Release)|340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
11215486|NCT02299479|EG000|Reported Event|Dexcom G4 Platinum CGM & Activity Monitor|"Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data.~Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.~Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity."
11215487|NCT02299570|BG000|Baseline|Group A|"Two enemas of RBX2660 administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes"
11215488|NCT02299570|BG001|Baseline|Group B|"Two enemas of placebo administered 7 days apart~Placebo: A suspension of saline and cryoprotectant"
11215489|NCT02299570|BG002|Baseline|Group C|"1 enema of RBX2660 and 1 enema of placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes~Placebo: A suspension of saline and cryoprotectant"
11215490|NCT02299570|BG003|Baseline|Total|Total of all reporting groups
11215491|NCT02299570|FG000|Participant Flow|Group A|"Two enemas of RBX2660 administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes"
11215492|NCT02299570|FG001|Participant Flow|Group B|"Two enemas of placebo administered 7 days apart~Placebo: A suspension of saline and cryoprotectant"
11215493|NCT02299570|FG002|Participant Flow|Group C|"1 enema of RBX2660 and 1 enema of placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes~Placebo: A suspension of saline and cryoprotectant"
11215494|NCT02299570|OG000|Outcome|Group A|"Two enemas of RBX2660 (microbiota suspension) administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes"
11215495|NCT02299570|OG001|Outcome|Group B|"Two enemas of placebo administered 7 days apart~Placebo: A suspension of saline and cryoprotectant"
11215496|NCT02299570|OG000|Outcome|Group B|"Two enemas of placebo administered 7 days apart~Placebo: A suspension of saline and cryoprotectant"
11215497|NCT02299570|OG001|Outcome|Group C|"1 enema of RBX2660 and 1 enema of placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes~Placebo: A suspension of saline and cryoprotectant"
11215498|NCT02299570|OG000|Outcome|Group A|"Two enemas of RBX2660 administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes"
11215499|NCT02299570|OG002|Outcome|Group C|"1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes~Placebo: A suspension of saline and cryoprotectant"
11215500|NCT02299570|OG000|Outcome|Group C|"One enemas of RBX2660 (microbiota suspension) and one enema of Placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant"
11215501|NCT02299570|OG001|Outcome|Group C|"One enema of RBX2660 (microbiota suspension) and one enema of Placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant"
11211811|NCT02274792|BG000|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
11211812|NCT02274792|FG000|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
11211813|NCT02274792|OG000|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
11211814|NCT02274792|EG000|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
11211815|NCT02274844|BG000|Baseline|Peer Coaching|"The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.~Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching"
11211816|NCT02274844|BG001|Baseline|Usual Care|At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
11211817|NCT02274844|BG002|Baseline|Total|Total of all reporting groups
11211818|NCT02274844|FG000|Participant Flow|Peer Coaching|"The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.~Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching"
11211819|NCT02274844|FG001|Participant Flow|Usual Care|At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
11211820|NCT02274844|OG000|Outcome|Peer Coaching|"The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.~Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching"
11211821|NCT02274844|OG001|Outcome|Usual Care|At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
11211822|NCT02274844|EG000|Reported Event|Peer Coaching|"The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.~Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching"
11211823|NCT02274844|EG001|Reported Event|Usual Care|At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
11211824|NCT02274857|BG000|Baseline|Standard PVI Ablation|"Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.~Standard PVI Ablation: Standard PVI procedure without FIRMap."
11211825|NCT02274857|BG001|Baseline|FIRM-guided Procedure and PVI|"FIRM-guided procedure followed by standard catheter ablation including PVI.~FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI."
11211826|NCT02274857|BG002|Baseline|Total|Total of all reporting groups
11211827|NCT02274857|FG000|Participant Flow|Standard PVI Ablation|"Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent atrial fibrillation (AF).~Standard PVI Ablation: Standard PVI procedure without Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)."
11211828|NCT02274857|FG001|Participant Flow|FIRM-guided Procedure and PVI|"Focal Impulse and Rotor Modulation (FIRM)-guided procedure followed by standard catheter ablation including PVI.~FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI."
11211829|NCT02274857|OG000|Outcome|Standard PVI Ablation|"Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.~Standard PVI Ablation: Standard PVI procedure without FIRMap."
11211830|NCT02274857|OG001|Outcome|FIRM-guided Procedure and PVI|"FIRM-guided procedure followed by standard catheter ablation including PVI.~FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI."
11211831|NCT02274857|OG000|Outcome|FIRM-guided Procedure and PVI|"FIRM-guided procedure followed by standard catheter ablation including PVI.~FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI."
11211832|NCT02274857|EG000|Reported Event|Standard PVI Ablation|"Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.~Standard PVI Ablation: Standard PVI procedure without FIRMap."
11211833|NCT02274857|EG001|Reported Event|FIRM-guided Procedure and PVI|"FIRM-guided procedure followed by standard catheter ablation including PVI.~FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI."
11244431|NCT02511236|EG000|Reported Event|Group Cognitive Behavioral Therapy|"Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~Group Cognitive Behavioral Therapy: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244432|NCT02511236|EG001|Reported Event|General Health Education|"Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].~General Health Education: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).~Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations."
11244433|NCT02511379|BG000|Baseline|Systane Balance|Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
11244434|NCT02511379|FG000|Participant Flow|Systane Balance|Propylene Glycol 0.6% eye drops, 1 drop QID (4 times/day) (with the last dose of each day at bedtime) in each eye for 90 days
11244435|NCT02511379|OG000|Outcome|Systane Balance|Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
11244436|NCT02511379|EG000|Reported Event|Systane Balance|Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
11244437|NCT02511431|BG000|Baseline|50mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244438|NCT02511431|BG001|Baseline|75mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244439|NCT02511431|BG002|Baseline|100mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244440|NCT02511431|BG003|Baseline|Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244441|NCT02511431|BG004|Baseline|Placebo Then 75mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244442|NCT02511431|BG005|Baseline|Placebo Then 100mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244443|NCT02511431|BG006|Baseline|Total|Total of all reporting groups
11244444|NCT02511431|FG000|Participant Flow|50mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same cytochrome p450 (CYP) system. Will be administered at 100 mg daily."
11244445|NCT02511431|FG001|Participant Flow|75mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11286258|NCT02885506|FG008|Participant Flow|Fed - Fasted|"250 mg P218 oral administration under fed then fasted conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10820024|NCT00053482|OG002|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
10820025|NCT00053482|OG003|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
11244446|NCT02511431|FG002|Participant Flow|100mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244447|NCT02511431|FG003|Participant Flow|Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244448|NCT02511431|FG004|Participant Flow|Placebo Then 75mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244449|NCT02511431|FG005|Participant Flow|Placebo Then 100mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244450|NCT02511431|OG000|Outcome|50mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244451|NCT02511431|OG001|Outcome|75mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244452|NCT02511431|OG002|Outcome|100mg/100mg Lonafarnib/Ritonavir|"Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily."
11244453|NCT02511431|OG003|Outcome|Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 50 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244454|NCT02511431|OG004|Outcome|Placebo Then 75mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 75 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244455|NCT02511431|OG005|Outcome|Placebo Then 100mg/100mg Lonafarnib/Ritonavir|"Placebo for 12 weeks then Lonafarnib/Ritonavir at 100 mg/100 mg daily for 12 weeks followed by 24 weeks of off therapy follow-up.~Lonafarnib: prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.~Ritonavir: FDA approved drug for use of boosting other drugs. Will be used to boost ritonavir as they both use the same CYP system. Will be administered at 100 mg daily.~Placebo: Placebo"
11244456|NCT02511431|EG000|Reported Event|24 Weeks of 50mg/100mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 50 mg/100 mg daily for 24 weeks.
11244457|NCT02511431|EG001|Reported Event|24 Weeks of 75mg/100mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 75 mg/100 mg daily for 24 weeks.
11244458|NCT02511431|EG002|Reported Event|24 Weeks of 100mg/100mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 100 mg/100 mg daily for 24 weeks.
11244459|NCT02511431|EG003|Reported Event|12 Weeks of Placebo|Placebo for first 12 weeks.
11244460|NCT02511431|EG004|Reported Event|12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 50 mg/100 mg daily for second 12 weeks.
11244461|NCT02511431|EG005|Reported Event|12 Weeks of 75mg/100mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 75 mg/100 mg daily for second 12 weeks.
11244462|NCT02511431|EG006|Reported Event|12 Weeks of 100mg/100mg Lonafarnib/Ritonavir|Lonafarnib/Ritonavir at 100 mg/100 mg daily for second 12 weeks.
11244463|NCT02511535|BG000|Baseline|Allergic Patients|Allergic patients receive TBE booster vaccination
11244464|NCT02511535|BG001|Baseline|Allergic Patients With De-sensitization Treatment|Allergic patients with de-sensitization treatment receive TBE booster vaccination
11244465|NCT02511535|BG002|Baseline|Healthy Controls|Healthy controls receive TBE booster vaccination
11244466|NCT02511535|BG003|Baseline|Total|Total of all reporting groups
11244467|NCT02511535|FG000|Participant Flow|Allergic Patients|"Allergic patients receive TBE booster vaccination~TBE booster vaccination"
11244468|NCT02511535|FG001|Participant Flow|Allergic Patients With De-sensitization Treatment|"Allergic patients with de-sensitization treatment receive TBE booster vaccination~TBE booster vaccination"
11244469|NCT02511535|FG002|Participant Flow|Healthy Controls|"Healthy controls receive TBE booster vaccination~TBE booster vaccination"
11244470|NCT02511535|OG000|Outcome|Allergic Patients|Allergic patients receive TBE booster vaccination
11244471|NCT02511535|OG001|Outcome|Allergic Patients With De-sensitization Treatment|Allergic patients with de-sensitization treatment receive TBE booster vaccination
11244472|NCT02511535|OG002|Outcome|Healthy Controls|Healthy controls receive TBE booster vaccination
11244473|NCT02511535|EG000|Reported Event|Allergic Patients|Allergic patients receive TBE booster vaccination
11211834|NCT02274870|BG000|Baseline|Liposomal Bupivacaine,|"Liposomal Bupivacaine 266mg, Knee Infiltration~Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint."
11211835|NCT02274870|BG001|Baseline|Bupivacaine HCl|"Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)~Bupivacaine HCl: Administered via CFNB."
11211836|NCT02274870|BG002|Baseline|Total|Total of all reporting groups
11211837|NCT02274870|FG000|Participant Flow|Liposomal Bupivacaine|"Liposomal Bupivacaine 266mg Knee Infiltration~Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint."
11211838|NCT02274870|FG001|Participant Flow|Bupivacaine HCl|"Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)~Bupivacaine HCl: Administered via CFNB"
11211839|NCT02274870|OG000|Outcome|Liposomal Bupivacaine,|"Liposomal Bupivacaine 266mg, Knee Infiltration~Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint"
11211840|NCT02274870|OG001|Outcome|Bupivacaine HCl|"Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)~Bupivacaine HCl: Administered via CFNB"
11211841|NCT02274870|OG000|Outcome|Liposomal Bupivacaine|"Liposomal Bupivacaine 266mg, Knee Infiltration~Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint"
11211842|NCT02274870|OG000|Outcome|Liposome Bupivacaine,|"Liposome Bupivacaine 266mg, Knee Infiltration~Liposome Bupivacaine: Administered via local tissue infiltration around the knee joint"
11211843|NCT02274870|OG000|Outcome|Liposomal Bupivacaine|"Liposomal Bupivacaine 266mg Knee Infiltration~Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint."
11211844|NCT02274870|EG000|Reported Event|Liposomal Bupivacaine|"Liposomal Bupivacaine 266mg, Knee Infiltration~Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint"
11211845|NCT02274870|EG001|Reported Event|Bupivacaine HCl|"Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)~Bupivacaine HCl: Administered via CFNB"
11211846|NCT02274948|BG000|Baseline|Metformin|"166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).~Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia"
11211847|NCT02274948|BG001|Baseline|Placebo|"173 were randomized to receive placebo~Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one"
11211848|NCT02274948|BG002|Baseline|Total|Total of all reporting groups
11211849|NCT02274948|FG000|Participant Flow|Metformin|"8-10.99 year old children will receive metformin. Initially children will be given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
11211850|NCT02274948|FG001|Participant Flow|Placebo|"A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
11211851|NCT02274948|OG000|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
11211852|NCT02274948|OG001|Outcome|Placebo|173 were randomized to receive placebo
11211853|NCT02274948|OG000|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)
11211854|NCT02274948|EG000|Reported Event|Metformin|"8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
11211855|NCT02274948|EG001|Reported Event|Placebo|"The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
11211856|NCT02275026|BG000|Baseline|Functional Magnetic Resonance Imaging|"Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.~Functional magnetic resonance imaging: Diffusion tensor imaging"
11211857|NCT02275026|FG000|Participant Flow|Functional Magnetic Resonance Imaging|"Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.~Functional magnetic resonance imaging: Diffusion tensor imaging"
11211858|NCT02275026|OG000|Outcome|Age Decade 40-49|Groups divided by age decade
11211859|NCT02275026|OG001|Outcome|Age Decade 50-59|Groups divided by age decade
11211860|NCT02275026|OG002|Outcome|Age Decade 60-69|Groups divided by age decade
11211861|NCT02275026|OG003|Outcome|Age Decade 70-80|Groups divided by age decade
11211862|NCT02275026|EG000|Reported Event|Functional Magnetic Resonance Imaging|"Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.~Functional magnetic resonance imaging: Diffusion tensor imaging"
11215502|NCT02299570|EG000|Reported Event|Group A|"Two enemas of RBX2660 administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes"
11211863|NCT02275052|BG000|Baseline|UMEC/VI 62.5/25 mcg and Placebo in One of the Two Sequences|Par. received a sequence consisting of the following 2 treatments: One inhalation of UMEC/VI 62.5/25 mcg or placebo once daily using a DPI. Each treatment was self-administered in the morning for 12 weeks. The treatments were separated by a 12 to 17 day washout period; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211864|NCT02275052|FG000|Participant Flow|Placebo Then UMEC/VI 62.5/25 µg|Participants received Placebo and then umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 micrograms (µg)/25 µg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211865|NCT02275052|FG001|Participant Flow|UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/ VI 62.5 µg/25 µg and then placebo each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211866|NCT02275052|FG002|Participant Flow|Period 2: UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/VI 62.5 µg/25 µg and then Placebo each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211867|NCT02275052|FG003|Participant Flow|Period 2: Placebo Then UMEC/VI 62.5/25 µg|Participants received placebo and then UMEC/VI 62.5 µg/25 µg each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211868|NCT02275052|OG000|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211869|NCT02275052|OG001|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211870|NCT02275052|EG000|Reported Event|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211871|NCT02275052|EG001|Reported Event|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
11211872|NCT02275065|BG000|Baseline|Bictegravir 5 mg|Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days
11211873|NCT02275065|BG001|Baseline|Bictegravir 25 mg|Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days
11211874|NCT02275065|BG002|Baseline|Bictegravir 50 mg|Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days
11211875|NCT02275065|BG003|Baseline|Bictegravir 100 mg|Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days
11211876|NCT02275065|BG004|Baseline|Placebo|Placebo matched to bictegravir tablet administered orally once daily for 10 days
11211877|NCT02275065|BG005|Baseline|Total|Total of all reporting groups
11211878|NCT02275065|FG000|Participant Flow|Bictegravir 5 mg|Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days
11211879|NCT02275065|FG001|Participant Flow|Bictegravir 25 mg|Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days
11211880|NCT02275065|FG002|Participant Flow|Bictegravir 50 mg|Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days
11211881|NCT02275065|FG003|Participant Flow|Bictegravir 100 mg|Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days
11211882|NCT02275065|FG004|Participant Flow|Placebo|Placebo matched to bictegravir tablet administered orally once daily for 10 days
11211883|NCT02275065|OG000|Outcome|Bictegravir 5 mg|Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days
11211884|NCT02275065|OG001|Outcome|Bictegravir 25 mg|Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days
11211885|NCT02275065|OG002|Outcome|Bictegravir 50 mg|Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days
11211886|NCT02275065|OG003|Outcome|Bictegravir 100 mg|Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days
11211887|NCT02275065|OG004|Outcome|Placebo|Placebo matched to bictegravir tablet administered orally once daily for 10 days
11211888|NCT02275065|EG000|Reported Event|Bictegravir 5 mg|Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days
11211889|NCT02275065|EG001|Reported Event|Bictegravir 25 mg|Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days
11211890|NCT02275065|EG002|Reported Event|Bictegravir 50 mg|Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days
11211891|NCT02275065|EG003|Reported Event|Bictegravir 100 mg|Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days
11211892|NCT02275065|EG004|Reported Event|Placebo|Placebo matched to bictegravir tablet administered orally once daily for 10 days
11211893|NCT02275117|BG000|Baseline|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Day 0
11211894|NCT02275117|BG001|Baseline|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Day 0
11211895|NCT02275117|BG002|Baseline|30 mg ALD403|Participants received a single 30 mg IV infusion of ALD403 on Day 0
11211896|NCT02275117|BG003|Baseline|10 mg ALD403|Participants received a single 10 mg IV infusion of ALD403 on Day 0
11211897|NCT02275117|BG004|Baseline|Placebo|Participants received a single placebo IV infusion on Day 0
11211898|NCT02275117|BG005|Baseline|Total|Total of all reporting groups
11211899|NCT02275117|FG000|Participant Flow|300 mg ALD403|Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Day 0
11211900|NCT02275117|FG001|Participant Flow|100 mg ALD403|Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Day 0
11211901|NCT02275117|FG002|Participant Flow|30 mg ALD403|Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Day 0
11211902|NCT02275117|FG003|Participant Flow|10 mg ALD403|Participants were randomized to receive a single 10 mg IV infusion of ALD403 on Day 0
11211903|NCT02275117|FG004|Participant Flow|Placebo|Participants were randomized to receive a single placebo IV infusion on Day 0
11211904|NCT02275117|OG000|Outcome|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Day 0
11211905|NCT02275117|OG001|Outcome|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Day 0
11211906|NCT02275117|OG002|Outcome|30 mg ALD403|Participants received a single 30 mg IV infusion of ALD403 on Day 0
11211907|NCT02275117|OG003|Outcome|10 mg ALD403|Participants received a single 10 mg IV infusion of ALD403 on Day 0
11211908|NCT02275117|OG004|Outcome|Placebo|Participants received a single placebo IV infusion on Day 0
11211909|NCT02275117|EG000|Reported Event|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Day 0
11211910|NCT02275117|EG001|Reported Event|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Day 0
11211911|NCT02275117|EG002|Reported Event|30 mg ALD403|Participants received a single 30 mg IV infusion of ALD403 on Day 0
11211912|NCT02275117|EG003|Reported Event|10 mg ALD403|Participants received a single 10 mg IV infusion of ALD403 on Day 0
11211913|NCT02275117|EG004|Reported Event|Placebo|Participants received a single placebo IV infusion on Day 0
11211914|NCT02275156|BG000|Baseline|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211915|NCT02275156|BG001|Baseline|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211916|NCT02275156|BG002|Baseline|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211917|NCT02275156|BG003|Baseline|Total|Total of all reporting groups
11211918|NCT02275156|FG000|Participant Flow|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211919|NCT02275156|FG001|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211920|NCT02275156|FG002|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211921|NCT02275156|OG000|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
10969589|NCT00906698|FG005|Participant Flow|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969590|NCT00906698|OG000|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
11211922|NCT02275156|OG001|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211923|NCT02275156|OG002|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211924|NCT02275156|EG000|Reported Event|Evolocumab 140 mg - Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211925|NCT02275156|EG001|Reported Event|Evolocumab 140 mg - Severe RI|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211926|NCT02275156|EG002|Reported Event|Evolocumab 140 mg - ESRD Requiring Hemodialysis|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211927|NCT02275156|EG003|Reported Event|Evolocumab 140 mg - Total|Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
11211928|NCT02275338|BG000|Baseline|Lanreotide Autogel® 120 mg - All Subjects|"All subjects were administered an initial injection of lanreotide Autogel® 120 mg via subcutaneous injection at Day 0 (Phase 1).~Subjects who completed the 28 days of Phase 1 and who were responders as defined by the protocol, had the opportunity to enter Phase 2 and receive a second subcutaneous injection of lanreotide Autogel® 120 mg.~All subjects continued to receive standard of care throughout the study."
11215503|NCT02299570|EG001|Reported Event|Group B|"Two enemas of placebo administered 7 days apart~Placebo: A suspension of saline and cryoprotectant"
11215504|NCT02299570|EG002|Reported Event|Group C|"1 enema of RBX2660 and 1 enema of placebo administered 7 days apart~RBX2660 (microbiota suspension): A suspension of intestinal microbes~Placebo: A suspension of saline and cryoprotectant"
11211929|NCT02275338|FG000|Participant Flow|Lanreotide Autogel® 120 mg - All Subjects|"All subjects were administered an initial injection of lanreotide Autogel® 120 milligrams (mg) via subcutaneous injection at Day 0 (Phase 1).~Subjects who completed the 28 days of Phase 1 and who were responders as defined by the protocol, had the opportunity to enter Phase 2 and receive a second subcutaneous injection of lanreotide Autogel® 120 mg.~All subjects continued to receive standard of care throughout the study."
11211930|NCT02275338|OG000|Outcome|Lanreotide Autogel® 120 mg|"All subjects were administered an initial injection of lanreotide Autogel® 120 mg via subcutaneous injection at Day 0 (Phase 1).~Subjects who completed the 28 days of Phase 1 and who were responders as defined by the protocol, had the opportunity to enter Phase 2 and receive a second subcutaneous injection of lanreotide Autogel® 120 mg.~All subjects continued to receive standard of care throughout the study."
11211931|NCT02275338|OG000|Outcome|Lanreotide Autogel® 120 mg - All Subjects|"All subjects were administered an initial injection of lanreotide Autogel® 120 mg via subcutaneous injection at Day 0 (Phase 1).~Subjects who completed the 28 days of Phase 1 and who were responders as defined by the protocol, had the opportunity to enter Phase 2 and receive a second subcutaneous injection of lanreotide Autogel® 120 mg.~All subjects continued to receive standard of care throughout the study."
11211932|NCT02275338|EG000|Reported Event|Lanreotide Autogel® 120 mg - All Subjects|"All subjects were administered an initial injection of lanreotide Autogel® 120 mg via subcutaneous injection at Day 0 (Phase 1).~Subjects who completed the 28 days of Phase 1 and who were responders as defined by the protocol, had the opportunity to enter Phase 2 and receive a second subcutaneous injection of lanreotide Autogel® 120 mg.~All subjects continued to receive standard of care throughout the study."
11211933|NCT02275364|BG000|Baseline|Overall|Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant.
11211934|NCT02275364|FG000|Participant Flow|Sequence 1|In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
11211935|NCT02275364|FG001|Participant Flow|Sequence 2|In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
11211936|NCT02275364|OG000|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
11211937|NCT02275364|OG001|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
11211938|NCT02275364|OG002|Outcome|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
11211939|NCT02275364|OG003|Outcome|Test Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
11211940|NCT02275364|OG000|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
11211941|NCT02275364|OG002|Outcome|Decongestant|A nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
11211942|NCT02275364|OG003|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
11211943|NCT02275364|OG002|Outcome|Decongestant|A marketed nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
11211944|NCT02275364|OG000|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
11211945|NCT02275364|OG001|Outcome|Placebo Strip|Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
11211946|NCT02275364|OG000|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
11211947|NCT02275364|EG000|Reported Event|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
11211948|NCT02275364|EG001|Reported Event|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
11211949|NCT02275364|EG002|Reported Event|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
11211950|NCT02275364|EG003|Reported Event|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
11211951|NCT02275611|BG000|Baseline|Intranasal Oxytocin Spray (Syntocinon)|Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal
11211952|NCT02275611|BG001|Baseline|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal
11211953|NCT02275611|BG002|Baseline|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
11211954|NCT02275611|BG003|Baseline|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
11244474|NCT02511535|EG001|Reported Event|Allergic Patients With De-sensitization Treatment|Allergic patients with de-sensitization treatment receive TBE booster vaccination
11211955|NCT02275611|BG004|Baseline|Total|Total of all reporting groups
11211956|NCT02275611|FG000|Participant Flow|Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks.~Inpatient Withdrawal"
11211957|NCT02275611|FG001|Participant Flow|Placebo Comparator: Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal
11211958|NCT02275611|FG002|Participant Flow|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
11211959|NCT02275611|FG003|Participant Flow|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
11211960|NCT02275611|OG000|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
11211961|NCT02275611|OG001|Outcome|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
11211962|NCT02275611|OG000|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|Syntocinon Spray 3-4 doses daily inpatient
11211963|NCT02275611|OG001|Outcome|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient
11211964|NCT02275611|OG000|Outcome|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
11211965|NCT02275611|OG001|Outcome|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
11211966|NCT02275611|EG000|Reported Event|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
11211967|NCT02275611|EG001|Reported Event|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
11211968|NCT02275611|EG002|Reported Event|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
11211969|NCT02275611|EG003|Reported Event|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
11211970|NCT02275767|BG000|Baseline|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
11211971|NCT02275767|BG001|Baseline|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
11211972|NCT02275767|BG002|Baseline|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
11211973|NCT02275767|BG003|Baseline|Total|Total of all reporting groups
11211974|NCT02275767|FG000|Participant Flow|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
11211975|NCT02275767|FG001|Participant Flow|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
11211976|NCT02275767|FG002|Participant Flow|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
11211977|NCT02275767|OG000|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
11211978|NCT02275767|OG001|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
11211979|NCT02275767|OG002|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
11211980|NCT02275767|EG000|Reported Event|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
11211981|NCT02275767|EG001|Reported Event|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
11211982|NCT02275767|EG002|Reported Event|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
11211983|NCT02275780|BG000|Baseline|Doravirine 100 mg|Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
11211984|NCT02275780|BG001|Baseline|Daurunavir 800 mg + Ritonavir 100 mg|Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
10820026|NCT00053482|OG004|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
11211985|NCT02275780|BG002|Baseline|Total|Total of all reporting groups
11211986|NCT02275780|FG000|Participant Flow|Doravirine 100 mg|Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for an additional 96 weeks. Eligible participants may continue to receive the same treatment regimen in Study Extension 2 until doravirine becomes locally available, or for an additional 96 weeks, whichever comes first.
11211987|NCT02275780|FG001|Participant Flow|Daurunavir 800 mg + Ritonavir 100 mg|Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for 96 weeks. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for an additional 96 weeks. Eligible participants may continue to receive the same treatment regimen in Study Extension 2 until doravirine becomes locally available, or for an additional 96 weeks, whichever comes first.
11211988|NCT02275780|OG000|Outcome|Doravirine 100 mg|Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
11211989|NCT02275780|OG001|Outcome|Daurunavir 800 mg + Ritonavir 100 mg|Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
11211990|NCT02275780|EG000|Reported Event|Doravirine 100 mg|Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
11211991|NCT02275780|EG001|Reported Event|Daurunavir 800 mg + Ritonavir 100 mg|Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o., q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o., q.d. for 96 weeks in the Base Study.
11211992|NCT02275819|BG000|Baseline|Control|Will not receive intervention with exercise
11211993|NCT02275819|BG001|Baseline|Intervention Group|2 groups will receive 2 different types of exercise
11211994|NCT02275819|BG002|Baseline|Total|Total of all reporting groups
11211995|NCT02275819|FG000|Participant Flow|Control|Will not receive intervention with exercise
11211996|NCT02275819|FG001|Participant Flow|Intervention Group|2 groups will receive 2 different types of exercise
11211997|NCT02275819|OG000|Outcome|Control|Will not receive intervention with exercise
11211998|NCT02275819|OG001|Outcome|Intervention Group|2 groups will receive 2 different types of exercise
11211999|NCT02275819|EG000|Reported Event|Control|Will not receive intervention with exercise
11212000|NCT02275819|EG001|Reported Event|Intervention Group|2 groups will receive 2 different types of exercise
11212001|NCT02275923|BG000|Baseline|Diagnostic|"'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.~Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor"
11212002|NCT02275923|FG000|Participant Flow|Diagnostic|"'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.~Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor"
11212003|NCT02275923|OG000|Outcome|Diagnostic|"'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.~Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor"
11212004|NCT02275923|EG000|Reported Event|Diagnostic|"'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.~Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor"
11212005|NCT02276027|BG000|Baseline|BYL719 350 mg QD|Patient's tumor must have molecular alteration of the PIK3CA gene.
11212006|NCT02276027|BG001|Baseline|INC280 400 mg BID Tab/600 mg BID Cap|Patient's tumor must have molecular alteration of the c-MET gene.
11212007|NCT02276027|BG002|Baseline|LDK378 750 mg QD|Patient's tumor must have ALK or ROS1 gene rearrangement.
11212008|NCT02276027|BG003|Baseline|MEK162 45 mg BID|Patient's tumor must have KRAS, NRAS or BRAF mutation.
11212009|NCT02276027|BG004|Baseline|Total|Total of all reporting groups
11212010|NCT02276027|FG000|Participant Flow|BYL719 350 mg QD|Patient's tumor must have molecular alteration of the PIK3CA gene.
11212011|NCT02276027|FG001|Participant Flow|INC280 400 mg BID Tab/600 mg BID Cap|Patient's tumor must have molecular alteration of the c-MET gene.
11212012|NCT02276027|FG002|Participant Flow|LDK378 750 mg QD|Patient's tumor must have ALK or ROS1 gene rearrangement.
11212013|NCT02276027|FG003|Participant Flow|MEK162 45 mg BID|Patient's tumor must have KRAS, NRAS or BRAF mutation.
11212014|NCT02276027|OG000|Outcome|BYL719 350 mg QD|Patient's tumor must have molecular alteration of the PIK3CA gene.
11212015|NCT02276027|OG001|Outcome|INC280 400 mg BID Tab/600 mg BID Cap|Patient's tumor must have molecular alteration of the c-MET gene.
11212016|NCT02276027|OG002|Outcome|LDK378 750 mg QD|Patient's tumor must have ALK or ROS1 gene rearrangement.
11212017|NCT02276027|OG003|Outcome|MEK162 45 mg BID|Patient's tumor must have KRAS, NRAS or BRAF mutation.
11212018|NCT02276027|EG000|Reported Event|BYL719 350 mg QD|Patient's tumor must have molecular alteration of the PIK3CA gene.
11212019|NCT02276027|EG001|Reported Event|INC280 400 mg BID Tab/600 mg BID Cap|Patient's tumor must have molecular alteration of the c-MET gene.
11212020|NCT02276027|EG002|Reported Event|LDK378 750 mg QD|Patient's tumor must have ALK or ROS1 gene rearrangement.
11212021|NCT02276027|EG003|Reported Event|MEK162 45 mg BID|Patient's tumor must have KRAS, NRAS or BRAF mutation.
11212022|NCT02276040|BG000|Baseline|Exparalel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
10820027|NCT00053482|EG000|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
11212023|NCT02276040|FG000|Participant Flow|Exparel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
11212024|NCT02276040|OG000|Outcome|Exparalel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
11212025|NCT02276040|EG000|Reported Event|Exparel|"Participants received Exparel (periarticular bupivicaine and liposomal bupivicaine).~periarticular bupivicaine and liposomal bupivicaine: Participants received Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel was administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine)."
11212026|NCT02276053|BG000|Baseline|Lacosamide|Patients with brain tumor-related epilepsy (BTRE), secondary to low-grade glioma (WHO Grade 1 to 2) and with at least 1 partial-onset seizure in the 8 weeks prior to start of lacosamide (LCM) treatment, routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs (AEDs) and who were included in the Safety Set (SS).
11212027|NCT02276053|FG000|Participant Flow|Lacosamide|Patients with brain tumor-related epilepsy (BTRE), secondary to low-grade glioma (WHO Grade 1 to 2) and with at least 1 partial-onset seizure in the 8 weeks prior to start of lacosamide (LCM) treatment, routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs (AEDs) and who were included in the Safety Set (SS).
11212028|NCT02276053|OG000|Outcome|Lacosamide (FAS)|Patients with BTRE, secondary to low-grade glioma (WHO Grade 1 to 2) and with at least 1 partial-onset seizure in the 8 weeks prior to start of LCM treatment, routinely treated with lacosamide as add on to one or two baseline AEDs and who were included in the Full Analysis Set (FAS), having at least one post-Baseline Patient Global Impression of Change or seizure assessment.
11212029|NCT02276053|OG000|Outcome|Lacosamide (SS)|Patients with BTRE, secondary to low-grade glioma (WHO Grade 1 to 2) and with at least 1 partial-onset seizure in the 8 weeks prior to start of LCM treatment, routinely treated with lacosamide as add on to one or two baseline AEDs and who were included in the SS.
11212030|NCT02276053|EG000|Reported Event|Lacosamide (SS)|Patients with BTRE, secondary to low-grade glioma (WHO Grade 1 to 2) and with at least 1 partial-onset seizure in the 8 weeks prior to start of LCM treatment, routinely treated with lacosamide as add on to one or two baseline AEDs and who were included in the SS.
11212031|NCT02276222|BG000|Baseline|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
11212032|NCT02276222|BG001|Baseline|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
11212033|NCT02276222|BG002|Baseline|Total|Total of all reporting groups
11212034|NCT02276222|FG000|Participant Flow|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
11212035|NCT02276222|FG001|Participant Flow|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
11212036|NCT02276222|OG000|Outcome|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
10820028|NCT00053482|EG001|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
10820029|NCT00053482|EG002|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
11212037|NCT02276222|OG001|Outcome|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
11212038|NCT02276222|EG000|Reported Event|SUN-101 50 mcg BID eFlow (CS) Nebulizer|"SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer~SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer"
11212039|NCT02276222|EG001|Reported Event|Spiriva 18 mcg QD Handihaler|"Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler~Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler"
11212040|NCT02276274|BG000|Baseline|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
11244475|NCT02511535|EG002|Reported Event|Healthy Controls|Healthy controls receive TBE booster vaccination
11212041|NCT02276274|BG001|Baseline|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
11212042|NCT02276274|BG002|Baseline|Total|Total of all reporting groups
11212043|NCT02276274|FG000|Participant Flow|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
11212044|NCT02276274|FG001|Participant Flow|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
11212045|NCT02276274|OG000|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
11212046|NCT02276274|OG001|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
11212047|NCT02276274|EG000|Reported Event|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
11212048|NCT02276274|EG001|Reported Event|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
11212049|NCT02276482|BG000|Baseline|Tedizolid Phosphate|Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212050|NCT02276482|BG001|Baseline|Antibiotic Comparator Drug|IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212051|NCT02276482|BG002|Baseline|Total|Total of all reporting groups
11212052|NCT02276482|FG000|Participant Flow|Tedizolid Phosphate|Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212053|NCT02276482|FG001|Participant Flow|Antibiotic Comparator Drug|IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212054|NCT02276482|OG000|Outcome|Tedizolid Phosphate|Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212055|NCT02276482|OG001|Outcome|Antibiotic Comparator Drug|IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212056|NCT02276482|EG000|Reported Event|Tedizolid Phosphate|Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212057|NCT02276482|EG001|Reported Event|Antibiotic Comparator Drug|IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
11212058|NCT02276612|BG000|Baseline|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
11212059|NCT02276612|BG001|Baseline|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
11212060|NCT02276612|BG002|Baseline|Total|Total of all reporting groups
11212061|NCT02276612|FG000|Participant Flow|E/C/F/TAF (12 - 17 Years of Age)|"Participants 12 - 17 years of age received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.~Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
11212062|NCT02276612|FG001|Participant Flow|E/C/F/TAF (≥ 18 Years of Age)|"Participants 18 years of age or older received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.~Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.~Note: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening."
11212063|NCT02276612|OG000|Outcome|E/C/F/TAF (12 - 17 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
11212064|NCT02276612|OG001|Outcome|E/C/F/TAF (≥ 18 Years of Age)|E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
11212065|NCT02276612|EG000|Reported Event|E/C/F/TAF (12 - 17 Years of Age)|"E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age.~Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
11212066|NCT02276612|EG001|Reported Event|E/C/F/TAF (≥ 18 Years of Age)|"E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older.~Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase."
11212067|NCT02276638|BG000|Baseline|18-28 Years Old Non-pathologic|18-28 years old Non-pathologic Device: Nidek CEM-530
11212068|NCT02276638|BG001|Baseline|29-80 Years Old Non-pathologic|29-80 years old Non-pathologic Device: Nidek CEM-530
11212069|NCT02276638|BG002|Baseline|29-80 Years Old Pathological|29-80 years old pathological Device: Nidek CEM-530
11212070|NCT02276638|BG003|Baseline|Total|Total of all reporting groups
11212071|NCT02276638|FG000|Participant Flow|18-28 Years Old Non-pathologic|18-28 years old Non-pathologic Device: Nidek CEM-530
11212072|NCT02276638|FG001|Participant Flow|29-80 Years Old Non-pathologic|29-80 years old Non-pathologic Device: Nidek CEM-530
11212073|NCT02276638|FG002|Participant Flow|29-80 Years Old Pathological|29-80 years old pathological Device: Nidek CEM-530
11212074|NCT02276638|OG000|Outcome|18-28 Years Old Non-pathologic|18-28 years old Non-pathologic Device: Nidek CEM-530
11212075|NCT02276638|OG001|Outcome|29-80 Years Old Non-pathologic|29-80 years old Non-pathologic Device: Nidek CEM-530
11212076|NCT02276638|OG002|Outcome|29-80 Years Old Pathological|29-80 years old pathological Device: Nidek CEM-530
11212077|NCT02276638|EG000|Reported Event|18-28 Years Old Non-pathologic|"Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL~Specular Microscope: Nidek CEM-530~Specular Microscope: Konan CELLCHECK XL"
11212078|NCT02276638|EG001|Reported Event|29-9- Years Old Non-pathologic|"Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL~Specular Microscope: Nidek CEM-530~Specular Microscope: Konan CELLCHECK XL"
11212079|NCT02276638|EG002|Reported Event|29-80 Years Old Pathological|"Device: Nidek CEM-530 Device: Konan Specular Microscope CELLCHEK XL~Specular Microscope: Nidek CEM-530~Specular Microscope: Konan CELLCHECK XL"
11212080|NCT02276807|BG000|Baseline|Brief Behavioral Activation|"This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.~Brief Behavioral Activation: This is a 4-session individual workshop using behavioral activation techniques."
11212081|NCT02276807|BG001|Baseline|Usual Care|"This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.~Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care."
11212082|NCT02276807|BG002|Baseline|Total|Total of all reporting groups
11212083|NCT02276807|FG000|Participant Flow|Brief Behavioral Activation|"This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.~Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques."
11212084|NCT02276807|FG001|Participant Flow|Usual Care|"This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.~Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care."
11212085|NCT02276807|OG000|Outcome|Brief Behavioral Activation|"This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.~Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques."
11212086|NCT02276807|OG001|Outcome|Usual Care|"This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.~Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care."
11212087|NCT02276807|EG000|Reported Event|Brief Behavioral Activation|"This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.~Brief Behavioral Activation: This is a 4-session individual workshop using behavioral activation techniques."
11212088|NCT02276807|EG001|Reported Event|Usual Care|"This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.~Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care."
11212089|NCT02276872|BG000|Baseline|Cohort 1 (Transitioning From Parental)|Transitioned from IV or SC Remodulin to oral treprostinil
11212090|NCT02276872|BG001|Baseline|Cohort 2 (Transitioning From Inhaled)|Transitioned from inhaled prostacyclin to oral treprostinil
11212091|NCT02276872|BG002|Baseline|Cohort 3 (Add-on to Current PAH Therapy)|Treated with oral treprostinil as a de novo add-on to current PAH therapy
11212092|NCT02276872|BG003|Baseline|Total|Total of all reporting groups
11212093|NCT02276872|FG000|Participant Flow|Cohort 1 (Transitioning From Parental)|Transitioned from IV or SC Remodulin to oral treprostinil
11212094|NCT02276872|FG001|Participant Flow|Cohort 2 (Transitioning From Inhaled)|Transitioned from inhaled prostacyclin to oral treprostinil
11212095|NCT02276872|FG002|Participant Flow|Cohort 3 (Add-on to Current PAH Therapy)|Treated with oral treprostinil as a de novo add-on to current PAH therapy
11212096|NCT02276872|OG000|Outcome|Cohort 1 (Transitioning From Parental)|Transitioned from IV or SC Remodulin to oral treprostinil
11212097|NCT02276872|OG001|Outcome|Cohort 2 (Transitioning From Inhaled)|Transitioned from inhaled prostacyclin to oral treprostinil
11212098|NCT02276872|OG002|Outcome|Cohort 3 (Add-on to Current PAH Therapy)|Treated with oral treprostinil as a de novo add-on to current PAH therapy
11212099|NCT02276872|OG000|Outcome|Cohort 1 (Transitioning From Parental)|"Transitioned from IV or SC Remodulin to oral treprostinil~oral treprostinil"
11212100|NCT02276872|OG001|Outcome|Cohort 2 (Transitioning From Inhaled)|"Transitioned from inhaled prostacyclin to oral treprostinil~oral treprostinil"
11212101|NCT02276872|OG002|Outcome|Cohort 3 (Add-on to Current PAH Therapy)|"Treated with oral treprostinil as a de novo add-on to current PAH therapy~oral treprostinil"
11212102|NCT02276872|OG000|Outcome|Cohort 1 (Transitioning From Parenteral)|Transitioned from IV or SC Remodulin to oral treprostinil
11212103|NCT02276872|OG001|Outcome|Cohorts Combined After Oral Treprostinil Administration|Combined PK data for Cohorts 1, 2, and 3 combined after oral treprostinil administration
11212104|NCT02276872|EG000|Reported Event|Cohort 1 (Transitioning From Parental)|Transitioned from IV or SC Remodulin to oral treprostinil
11212105|NCT02276872|EG001|Reported Event|Cohort 2 (Transitioning From Inhaled)|Transitioned from inhaled prostacyclin to oral treprostinil
11212106|NCT02276872|EG002|Reported Event|Cohort 3 (Add-on to Current PAH Therapy)|Treated with oral treprostinil as a de novo add-on to current PAH therapy
11212107|NCT02276963|BG000|Baseline|Ublituximab Plus Glucocorticoids|"Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5~Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells."
11212108|NCT02276963|FG000|Participant Flow|Ublituximab Plus Glucocorticoids|"Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5~Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells."
11212109|NCT02276963|OG000|Outcome|Ublituximab Plus Glucocorticoids|"Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5~Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells."
11212110|NCT02276963|EG000|Reported Event|Ublituximab Plus Glucocorticoids|"Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5~Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells."
11212111|NCT02277054|BG000|Baseline|RHCIII-MPC Cornea Substitute|"Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.~Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage."
11212112|NCT02277054|FG000|Participant Flow|RHCIII-MPC Cornea Substitute|"Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.~Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage."
11212113|NCT02277054|OG000|Outcome|RHCIII-MPC Cornea Substitute|"Recombinant human collagen type III-methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.~Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage."
11212114|NCT02277054|OG000|Outcome|RHCIII-MPC Cornea Substitute|"Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.~Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage."
11212115|NCT02277054|EG000|Reported Event|RHCIII-MPC Cornea Substitute|"Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.~Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage."
11212116|NCT02277093|BG000|Baseline|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
11212117|NCT02277093|FG000|Participant Flow|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
11212118|NCT02277093|OG000|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
11212119|NCT02277093|EG000|Reported Event|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
11212120|NCT02277249|BG000|Baseline|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212121|NCT02277249|BG001|Baseline|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212122|NCT02277249|BG002|Baseline|Total|Total of all reporting groups
11212123|NCT02277249|FG000|Participant Flow|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212124|NCT02277249|FG001|Participant Flow|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212125|NCT02277249|OG000|Outcome|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212126|NCT02277249|OG001|Outcome|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212127|NCT02277249|EG000|Reported Event|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
11212128|NCT02277249|EG001|Reported Event|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
10820030|NCT00053482|EG003|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
11212129|NCT02277548|BG000|Baseline|Lyrica at 300 mg Per Day|Lyrica 300 mg: Lyrica 300 mg per day
11212130|NCT02277548|BG001|Baseline|Placebo|Placebo
11212131|NCT02277548|BG002|Baseline|Total|Total of all reporting groups
11212132|NCT02277548|FG000|Participant Flow|Lyrica at 300 mg Per Day|Lyrica 300 mg: Lyrica 300 mg per day
11212133|NCT02277548|FG001|Participant Flow|Placebo|Placebo
11212134|NCT02277548|OG000|Outcome|Lyrica at 300 mg Per Day|Lyrica 300 mg: Lyrica 300 mg per day
11212135|NCT02277548|OG001|Outcome|Placebo|Placebo
11212136|NCT02277548|EG000|Reported Event|Lyrica at 300 mg Per Day|Lyrica 300 mg: Lyrica 300 mg per day
11212137|NCT02277548|EG001|Reported Event|Placebo|Placebo
11212138|NCT02277626|BG000|Baseline|Total Number of Participants|
11212139|NCT02277626|FG000|Participant Flow|Vest First Then ElectroFlo|"Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000.~EnCourage Vest System: Airway Clearance Device"
11212140|NCT02277626|FG001|Participant Flow|ElectroFlo First Then Vest|"Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest.~Electro Flo 5000: Airway clearance device"
11212141|NCT02277626|OG000|Outcome|Vest|"VEST Arm~Incourage Vest System: Airway Clearance Device"
11212142|NCT02277626|OG001|Outcome|Elecflo Arm|"Elecflo Arm~Electro Flo 5000: Airway clearance device"
11212143|NCT02277626|OG000|Outcome|Vest Arm|"Vest Arm~Incourage Vest System: Airway Clearance Device"
11212144|NCT02277626|OG001|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
11212145|NCT02277626|OG000|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
11212146|NCT02277626|OG001|Outcome|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
11212147|NCT02277626|OG000|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
11212148|NCT02277626|EG000|Reported Event|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
11212149|NCT02277626|EG001|Reported Event|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
11212150|NCT02277639|BG000|Baseline|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11244476|NCT02511561|BG000|Baseline|6 mg OTO-201|6 mg ciprofloxacin: single administration
11244477|NCT02511561|BG001|Baseline|12 mg OTO-201|12 mg ciprofloxacin: single administration
11212151|NCT02277639|BG001|Baseline|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212152|NCT02277639|BG002|Baseline|Total|Total of all reporting groups
11212153|NCT02277639|FG000|Participant Flow|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212154|NCT02277639|FG001|Participant Flow|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212155|NCT02277639|OG000|Outcome|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212156|NCT02277639|OG001|Outcome|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212157|NCT02277639|EG000|Reported Event|Bone Marrow Failure Syndrome|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212158|NCT02277639|EG001|Reported Event|Immunodeficiency / Dysregulation|"Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells. Reduced intensity conditioning will include Busulfan, Fludarbine, Cyclophosphamide followed by stem cell infusion.~CD3+/CD19+ delpletion using CliniMACs device follwing reduced intensity conditioning: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells."
11212159|NCT02277665|BG000|Baseline|CUD Treatment Only|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD~CUD Treatment"
11212160|NCT02277665|BG001|Baseline|CUD and Tobacco Treatment|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco~CUD Treatment~Tobacco Treatment"
11212161|NCT02277665|BG002|Baseline|Total|Total of all reporting groups
11212162|NCT02277665|FG000|Participant Flow|CUD Treatment Only|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD~CUD Treatment"
11212163|NCT02277665|FG001|Participant Flow|CUD and Tobacco Treatment|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco~CUD Treatment~Tobacco Treatment"
11212164|NCT02277665|OG000|Outcome|CUD Treatment Only|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD~CUD Treatment"
11212165|NCT02277665|OG001|Outcome|CUD and Tobacco Treatment|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco~CUD Treatment~Tobacco Treatment"
11212166|NCT02277665|OG000|Outcome|CUD Treatment|Received CUD treatment and delayed Tobacco Intervention
11212167|NCT02277665|OG001|Outcome|CUD Treatment and Tobacco Intervention|Received CUD treatment and Tobacco Intervention simultaneously
11212168|NCT02277665|EG000|Reported Event|CUD Treatment Only|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD~CUD Treatment"
11212169|NCT02277665|EG001|Reported Event|CUD and Tobacco Treatment|"12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco~CUD Treatment~Tobacco Treatment"
11212170|NCT02277691|BG000|Baseline|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
11215505|NCT02299635|BG000|Baseline|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
11244478|NCT02511561|BG002|Baseline|24 mg OTO-201|24 mg ciprofloxacin: single administration
11212171|NCT02277691|FG000|Participant Flow|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
11212172|NCT02277691|OG000|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
11212173|NCT02277691|EG000|Reported Event|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.~For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
11212174|NCT02277743|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212175|NCT02277743|BG001|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212176|NCT02277743|BG002|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212177|NCT02277743|BG003|Baseline|Total|Total of all reporting groups
11212178|NCT02277743|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212179|NCT02277743|FG001|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212180|NCT02277743|FG002|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212181|NCT02277743|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212182|NCT02277743|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212183|NCT02277743|OG002|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212184|NCT02277743|EG000|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)
11212185|NCT02277743|EG001|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).
11212186|NCT02277743|EG002|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
11212187|NCT02277769|BG000|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212188|NCT02277769|BG001|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212189|NCT02277769|BG002|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212190|NCT02277769|BG003|Baseline|Total|Total of all reporting groups
11212191|NCT02277769|FG000|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212192|NCT02277769|FG001|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212193|NCT02277769|FG002|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212194|NCT02277769|OG000|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
11212195|NCT02277769|OG001|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212196|NCT02277769|OG002|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
11212197|NCT02277769|EG000|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)
11212198|NCT02277769|EG001|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).
11212199|NCT02277769|EG002|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
10820031|NCT00053482|EG004|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
10820032|NCT00041392|BG000|Baseline|Magnesium|100 mg/kg magnesium
10820033|NCT00041392|BG001|Baseline|0.9 % Saline|100 mg/kg 0.9 % saline
11244479|NCT02511561|BG003|Baseline|Total|Total of all reporting groups
11212200|NCT02277925|BG000|Baseline|Gore-Tex Permanent Suture|Participants in this arm will receive Gore-Tex permanent suture
11212201|NCT02277925|BG001|Baseline|PDS Delayed Absorbable Suture|Participants in this arm will receive 2-0 PDS delayed absorbable suture
11212202|NCT02277925|BG002|Baseline|Total|Total of all reporting groups
11212203|NCT02277925|FG000|Participant Flow|Gore-Tex Permanent Suture|Participants in this arm will receive Gore-Tex permanent suture
11212204|NCT02277925|FG001|Participant Flow|PDS Delayed Absorbable Suture|Participants in this arm will receive 2-0 PDS delayed absorbable suture
11212205|NCT02277925|OG000|Outcome|Gore-Tex Permanent Suture|Participants in this arm will receive Gore-Tex permanent suture
11212206|NCT02277925|OG001|Outcome|PDS Delayed Absorbable Suture|Participants in this arm will receive 2-0 PDS delayed absorbable suture
11212207|NCT02277925|OG000|Outcome|Gore-Tex Permanent Suture|"Participants in this arm will receive Gore-Tex permanent suture~Polytetrafluoroethylene: Suture used to attach mesh during sacral colpopexy surgery"
11212208|NCT02277925|OG001|Outcome|PDS Delayed Absorbable Suture|"Participants in this arm will receive 2-0 PDS delayed absorbable suture~Polydioxanone: Suture used to attach mesh during sacral colpopexy surgery"
11212209|NCT02277925|EG000|Reported Event|Gore-Tex Permanent Suture|Participants in this arm will receive Gore-Tex permanent suture
11212210|NCT02277925|EG001|Reported Event|PDS Delayed Absorbable Suture|Participants in this arm will receive 2-0 PDS delayed absorbable suture
11212211|NCT02277990|BG000|Baseline|TYRX Envelope|"The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.~TYRX Absorbable Antibacterial Envelope"
11212212|NCT02277990|BG001|Baseline|Control|No TYRX envelope, bare CIED
11212213|NCT02277990|BG002|Baseline|Total|Total of all reporting groups
11212214|NCT02277990|FG000|Participant Flow|TYRX Envelope|"The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.~TYRX Absorbable Antibacterial Envelope"
11212215|NCT02277990|FG001|Participant Flow|Control|No TYRX envelope, bare CIED
11212216|NCT02277990|OG000|Outcome|TYRX Envelope|"The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.~TYRX Absorbable Antibacterial Envelope"
11212217|NCT02277990|OG001|Outcome|Control|No TYRX envelope, bare CIED
11212218|NCT02277990|EG000|Reported Event|TYRX Envelope|"The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.~TYRX Absorbable Antibacterial Envelope"
11212219|NCT02277990|EG001|Reported Event|Control|No TYRX envelope, bare CIED
11212220|NCT02278003|BG000|Baseline|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
11212221|NCT02278003|BG001|Baseline|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
11212222|NCT02278003|BG002|Baseline|Total|Total of all reporting groups
11212223|NCT02278003|FG000|Participant Flow|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
11212224|NCT02278003|FG001|Participant Flow|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
11212225|NCT02278003|OG000|Outcome|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
11212226|NCT02278003|OG001|Outcome|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
11212227|NCT02278003|EG000|Reported Event|Children Going Under Sedation With Propofol|"Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.~measure the amnesic effects of propofol.~memory test~Propofol"
11212228|NCT02278003|EG001|Reported Event|Children Not Going Under Sedation|"A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.~memory test"
11212229|NCT02278146|BG000|Baseline|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212230|NCT02278146|BG001|Baseline|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212231|NCT02278146|BG002|Baseline|Total|Total of all reporting groups
11212232|NCT02278146|FG000|Participant Flow|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212233|NCT02278146|FG001|Participant Flow|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212234|NCT02278146|OG000|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212235|NCT02278146|OG001|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212236|NCT02278146|EG000|Reported Event|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212237|NCT02278146|EG001|Reported Event|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
11212238|NCT02278237|BG000|Baseline|VME Group|Video Module Education (VME)
11212239|NCT02278237|FG000|Participant Flow|VME Group|Video Module Education (VME): The RE will provide participants with a tablet device and will demonstrate how to access VME and complete the pre/post e-learning assessments. The RE will provide technical support but will neither participate directly in the education nor help with the self-assessments. The participants will first complete the pre-assessment e-learning tool on the tablet. They will then watch the video instruction that will provide a complete demonstration with verbal instructions on correct inhaler technique. Next the participants will complete the post-assessment e-learning tool. Based on participants' performance, they will be directed to further tailored video-instruction. The cycle of self-assessment and video instruction will continue until sufficient mastery has been achieved.
11212240|NCT02278237|OG000|Outcome|VME Group|Video Module Education (VME)
11212241|NCT02278237|EG000|Reported Event|VME Group|Video Module Education (VME)
11212242|NCT02278263|BG000|Baseline|Control|"Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212243|NCT02278263|BG001|Baseline|Intraarticular|"Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Tranexamic Acid: Given intraarticularly~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212244|NCT02278263|BG002|Baseline|Systemic|"Application of 20ml of normal saline topically after implantation of prosthesis; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet~Tranexamic Acid: Given intravenously~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212245|NCT02278263|BG003|Baseline|Total|Total of all reporting groups
11212246|NCT02278263|FG000|Participant Flow|Control|"Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212247|NCT02278263|FG001|Participant Flow|Intraarticular|"Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Tranexamic Acid: Given intraarticularly~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212248|NCT02278263|FG002|Participant Flow|Systemic|"Application of 20ml of normal saline topically after implantation of prosthesis; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet~Tranexamic Acid: Given intravenously~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212249|NCT02278263|OG000|Outcome|Control|"Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212250|NCT02278263|OG001|Outcome|Intraarticular|"Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Tranexamic Acid: Given intraarticularly~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212251|NCT02278263|OG002|Outcome|Systemic|"Application of 20ml of normal saline topically after implantation of prosthesis; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet~Tranexamic Acid: Given intravenously~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212252|NCT02278263|OG000|Outcome|Control|"Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis and left to sit for two minutes, excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212253|NCT02278263|OG001|Outcome|Topical|"Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Tranexamic Acid: Given intravenously or topically~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212254|NCT02278263|OG002|Outcome|Systemic|"Application of 20ml of normal saline topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet~Tranexamic Acid: Given intravenously or topically~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212255|NCT02278263|EG000|Reported Event|Control|"Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Normal saline (0.9% NaCl): Administered in all 3 groups"
11244480|NCT02511561|FG000|Participant Flow|6 mg OTO-201|6 mg ciprofloxacin: single administration
11212256|NCT02278263|EG001|Reported Event|Intraarticular|"Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.~Tranexamic Acid: Given intraarticularly~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212257|NCT02278263|EG002|Reported Event|Systemic|"Application of 20ml of normal saline topically after implantation of prosthesis; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet~Tranexamic Acid: Given intravenously~Normal saline (0.9% NaCl): Administered in all 3 groups"
11212258|NCT02278289|BG000|Baseline|Ultrasound Therapy Group|"Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.~ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks."
11212259|NCT02278289|BG001|Baseline|Paraffin Therapy Group|"Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C~paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C"
11212260|NCT02278289|BG002|Baseline|Total|Total of all reporting groups
11212261|NCT02278289|FG000|Participant Flow|Ultrasound Therapy Group|"Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.~ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks."
11212262|NCT02278289|FG001|Participant Flow|Paraffin Therapy Group|"Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C~paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C"
11212263|NCT02278289|OG000|Outcome|Ultrasound Therapy Group|"Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.~ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks."
11212264|NCT02278289|OG001|Outcome|Paraffin Therapy Group|"Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C~paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C"
11212265|NCT02278289|EG000|Reported Event|Ultrasound Therapy Group|"Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.~ultrasound: Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks."
11212266|NCT02278289|EG001|Reported Event|Paraffin Therapy Group|"Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C~paraffin therapy: Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C"
11212267|NCT02278328|BG000|Baseline|All Participants|"Subjects receive a single dose of STX209 or placebo starting at 15 mg, increasing to 30 mg on each of three separate occasions (different dose on each occasion, according to their randomization scheme Arm. Outcome measures are reported by dose administered (or placebo) and not by randomization schedule, since the same outcome measures are acquired after each dose administration. Subjects will receive STX209 via oral disintegrating tablets, administered in individual 15mg tablets.~A randomized acute dose-response design is employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate."
11212268|NCT02278328|FG000|Participant Flow|A. Placebo Then 15mg Then 30mg|"Subjects will receive a single dose of placebo, then (a week later) 15mg STX209 then (a week later) 30mg STX209. Subjects will receive STX209 via oral disintegrating tablets, administered in individual 15mg tablets.~A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Over the course of the three weeks, each participant will receive a single dose of placebo and a single dose of STX209 from smallest to largest (15mg, and 30mg). On each occasion, separated by 1 week, participants will receive either placebo or 15mg STX209 or 30mg STX209. MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate."
11212269|NCT02278328|FG001|Participant Flow|B. 15mg Then Placebo Then 30mg|"Subjects will receive a single dose of 15mg STX209, then (a week later) placebo then (a week later) 30mg STX209. Subjects will receive STX209 via oral disintegrating tablets, administered in individual 15mg tablets.~A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Over the course of the three weeks, each participant will receive a single dose of placebo and a single dose of STX209 from smallest to largest (15mg, and 30mg). On each occasion, separated by 1 week, participants will receive either placebo or 15mg STX209 or 30mg STX209. MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate."
11215506|NCT02299635|FG000|Participant Flow|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
10820034|NCT00041392|BG002|Baseline|Total|Total of all reporting groups
11212270|NCT02278328|FG002|Participant Flow|C. 15mg Then 30mg Then Placebo|"Subjects will receive a single dose of 15mg STX209, then (a week later) 30mg STX209 then (a week later) placebo . Subjects will receive STX209 via oral disintegrating tablets, administered in individual 15mg tablets.~A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Over the course of the three weeks, each participant will receive a single dose of placebo and a single dose of STX209 from smallest to largest (15mg, and 30mg). On each occasion, separated by 1 week, participants will receive either placebo or 15mg STX209 or 30mg STX209. MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate."
11212271|NCT02278328|OG000|Outcome|All Participants|Results post placebo and each dose (15 and 30mg)
11212272|NCT02278328|EG000|Reported Event|Placebo|Subjects will receive a single dose of placebo via oral disintegrating tablets, administered as two individual tablets.
11212273|NCT02278328|EG001|Reported Event|STX209 (15mg)|Subjects will receive a single dose of 15mg STX209 via oral disintegrating tablets, administered as two individual tablets (one being 15mg drug, one being placebo)
11212274|NCT02278328|EG002|Reported Event|STX209 (30mg)|Subjects will receive a single dose of 15mg STX209 via oral disintegrating tablets, administered as two individual tablets (each being 15mg drug)
11212275|NCT02278341|BG000|Baseline|Roxadustat|Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
11212276|NCT02278341|BG001|Baseline|ESA (Erythropoiesis-Stimulating Agent)|Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
11212277|NCT02278341|BG002|Baseline|Total|Total of all reporting groups
11212278|NCT02278341|FG000|Participant Flow|Roxadustat|Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
11212279|NCT02278341|FG001|Participant Flow|ESA (Erythropoiesis-Stimulating Agent)|Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
11212280|NCT02278341|OG000|Outcome|Roxadustat|Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
11212281|NCT02278341|OG001|Outcome|ESA (Erythropoiesis-Stimulating Agent)|Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
11212282|NCT02278341|OG000|Outcome|Roxadustat|Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met. .
11212283|NCT02278341|EG000|Reported Event|Roxadustat|Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
11215507|NCT02299635|OG000|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
11244481|NCT02511561|FG001|Participant Flow|12 mg OTO-201|12 mg ciprofloxacin: single administration
11244482|NCT02511561|FG002|Participant Flow|24 mg OTO-201|24 mg ciprofloxacin: single administration
11244483|NCT02511561|OG000|Outcome|6 mg OTO-201|6 mg ciprofloxacin: single administration
11244484|NCT02511561|OG001|Outcome|12 mg OTO-201|12 mg ciprofloxacin: single administration
11244485|NCT02511561|OG002|Outcome|24 mg OTO-201|24 mg ciprofloxacin: single administration
11244486|NCT02511561|OG001|Outcome|12 mg OTO-201|12 ciprofloxacin: single administration
11244487|NCT02511561|EG000|Reported Event|6 mg OTO-201|6 mg ciprofloxacin: single administration
11244488|NCT02511561|EG001|Reported Event|12 mg OTO-201|12 mg ciprofloxacin: single administration
11244489|NCT02511561|EG002|Reported Event|24 mg OTO-201|24 mg ciprofloxacin: single administration
11244490|NCT02511587|BG000|Baseline|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244491|NCT02511587|BG001|Baseline|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244492|NCT02511587|BG002|Baseline|Total|Total of all reporting groups
11244493|NCT02511587|FG000|Participant Flow|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244494|NCT02511587|FG001|Participant Flow|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244495|NCT02511587|OG000|Outcome|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244496|NCT02511587|OG001|Outcome|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244497|NCT02511587|EG000|Reported Event|Intra Muscular Application|"intra muscular application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244498|NCT02511587|EG001|Reported Event|Subcutaneous Application|"subcutaneous application of FSME-Immune vaccination~FSME-Immune vaccination: booster vaccination with FSME-Immune"
11244499|NCT02511678|BG000|Baseline|Cryoablation|All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
11244500|NCT02511678|FG000|Participant Flow|Cryoablation|All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
10820035|NCT00041392|FG000|Participant Flow|Magnesium|100 mg/kg magnesium
11244501|NCT02511678|OG000|Outcome|Cryoablation|All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
11244502|NCT02511678|OG000|Outcome|Cryoablation|All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
11244503|NCT02511678|EG000|Reported Event|Cryoablation|All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
11286259|NCT02885506|FG009|Participant Flow|Fasted - Fed|250 mg P218 oral administration under fasted then fed conditions.
10820036|NCT00041392|FG001|Participant Flow|0.9 % Saline|100 mg/kg 0.9 % saline
11212284|NCT02278341|EG001|Reported Event|ESA (Erythropoiesis-Stimulating Agent)|Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
11212285|NCT02278354|BG000|Baseline|Active Professional Fighters|Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212286|NCT02278354|BG001|Baseline|Retired Professional Fighters|Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212287|NCT02278354|BG002|Baseline|Total|Total of all reporting groups
11212288|NCT02278354|FG000|Participant Flow|Active Professional Fighters|Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212289|NCT02278354|FG001|Participant Flow|Retired Professional Fighters|Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212290|NCT02278354|OG000|Outcome|Cognitively Impaired Fighters|Fighters (active and retired) with cognitive impairment at baseline
11212291|NCT02278354|OG001|Outcome|Cognitively Normal Fighters|Fighters (active and retired) without cognitive impairment at baseline
11212292|NCT02278354|OG000|Outcome|Active Professional Fighters|Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212293|NCT02278354|OG001|Outcome|Retired Professional Fighters|Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212294|NCT02278354|EG000|Reported Event|Active Professional Fighters|Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212295|NCT02278354|EG001|Reported Event|Retired Professional Fighters|Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
11212296|NCT02278367|BG000|Baseline|Cognitively Impaired|Cognitively impaired subjects receiving a flortaucipir PET scan
11212297|NCT02278367|BG001|Baseline|Cognitively Normal|Cognitively normal subjects receiving a flortaucipir PET scan
11212298|NCT02278367|BG002|Baseline|Total|Total of all reporting groups
11212299|NCT02278367|FG000|Participant Flow|Cognitively Impaired|Cognitively impaired subjects receiving a flortaucipir PET scan
11212300|NCT02278367|FG001|Participant Flow|Cognitively Normal|Cognitively normal subjects receiving a flortaucipir PET scan
11212301|NCT02278367|OG000|Outcome|Cognitively Impaired|Cognitively impaired subjects receiving a flortaucipir PET scan
11212302|NCT02278367|OG001|Outcome|Cognitively Normal|Cognitively normal subjects receiving a flortaucipir PET scan
11212303|NCT02278367|EG000|Reported Event|Cognitively Impaired|Cognitively impaired subjects receiving a flortaucipir PET scan
11212304|NCT02278367|EG001|Reported Event|Cognitively Normal|Cognitively normal subjects receiving a flortaucipir PET scan
11212305|NCT02278471|BG000|Baseline|Usual Care|Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers.
11212306|NCT02278471|BG001|Baseline|Polypill|"The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.~Polypill will be taken once daily.~Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)"
11212307|NCT02278471|BG002|Baseline|Total|Total of all reporting groups
11212308|NCT02278471|FG000|Participant Flow|Usual Care|Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers.
11212309|NCT02278471|FG001|Participant Flow|Polypill|"The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.~Polypill will be taken once daily.~Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)"
11212310|NCT02278471|OG000|Outcome|Usual Care|Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers.
11212311|NCT02278471|OG001|Outcome|Polypill|"The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.~Polypill will be taken once daily.~Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)"
11212312|NCT02278471|OG000|Outcome|Usual Care|Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.
11212313|NCT02278471|EG000|Reported Event|Usual Care|Subjects in this arm will not receive any investigational medications. They will continue to receive usual medical care, as directed by their primary care providers.
11212314|NCT02278471|EG001|Reported Event|Polypill|"The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.~Polypill will be taken once daily.~Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)"
11212315|NCT02278484|BG000|Baseline|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
11212316|NCT02278484|FG000|Participant Flow|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
11212317|NCT02278484|OG000|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation Using XprESS and PathAssist Devices.
11212318|NCT02278484|OG000|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
11212319|NCT02278484|EG000|Reported Event|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
11212320|NCT02278562|BG000|Baseline|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
11212321|NCT02278562|BG001|Baseline|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
11212322|NCT02278562|BG002|Baseline|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
11212323|NCT02278562|BG003|Baseline|Total|Total of all reporting groups
11212324|NCT02278562|FG000|Participant Flow|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
11212325|NCT02278562|FG001|Participant Flow|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
11212326|NCT02278562|FG002|Participant Flow|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
11212327|NCT02278562|OG000|Outcome|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
11212328|NCT02278562|OG001|Outcome|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
11212329|NCT02278562|OG002|Outcome|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
11212330|NCT02278562|EG000|Reported Event|Anakinra|"100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~anakinra: 100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)"
11212331|NCT02278562|EG001|Reported Event|Actos|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months~actos: 30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)"
11212332|NCT02278562|EG002|Reported Event|Placebo 1 and 2|"Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months~placebo: placebo capsules and injection"
11212333|NCT02278614|BG000|Baseline|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
11212334|NCT02278614|BG001|Baseline|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
11212335|NCT02278614|BG002|Baseline|Total|Total of all reporting groups
11212336|NCT02278614|FG000|Participant Flow|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
11212337|NCT02278614|FG001|Participant Flow|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
11212338|NCT02278614|OG000|Outcome|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
11212339|NCT02278614|OG001|Outcome|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
11212340|NCT02278614|EG000|Reported Event|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
11212341|NCT02278614|EG001|Reported Event|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
11212342|NCT02278640|BG000|Baseline|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
11212343|NCT02278640|FG000|Participant Flow|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
11212344|NCT02278640|OG000|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
11212345|NCT02278640|EG000|Reported Event|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
11212346|NCT02278783|BG000|Baseline|All Patients|
11212347|NCT02278783|FG000|Participant Flow|All Patients|
11212348|NCT02278783|OG000|Outcome|All Patients|
11212349|NCT02278783|EG000|Reported Event|All Patients|
11286260|NCT02885506|OG000|Outcome|Cohort 1|"10 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212350|NCT02278939|BG000|Baseline|Fit and Trim Group|"This groups will start with the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for 3 months, a pedometer/accelerometer, access to a study private Facebook virtual social networking group, and and 4 in-person intervention session with individually tailored goals for physical activity, diet, and weight. At 3months, the Fit and Trim group will transition to a maintenance phase for 3 months, receive one in-person session for maintenance support (at 4.5 months) and complete the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention uses a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino"
11212351|NCT02278939|BG001|Baseline|Pedometer Only Group|"This group will start with the pedometer/accelerometer only to monitor/ track their physical activity step-counts for the initial 3 months. In addition, subjects will receive an educational materials on Hepatitis B and Tuberculosis. At 3 months pedometer only group will transition to receive the Filipinos Fit and Trim Weight Loss Program intervention (as previously described) for the next 3 months and complete the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in st"
11212352|NCT02278939|BG002|Baseline|Total|Total of all reporting groups
11212353|NCT02278939|FG000|Participant Flow|Fit and Trim Group|"This groups will start with the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for 3 months, a pedometer/accelerometer, access to a study private Facebook virtual social networking group, and and 4 in-person intervention session with individually tailored goals for physical activity, diet, and weight. At 3months, the Fit and Trim group will transition to a maintenance phase for 3 months, receive one in-person session for maintenance support (at 4.5 months) and complete the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention uses a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino"
11212354|NCT02278939|FG001|Participant Flow|Pedometer Only Group|"This group will start with the pedometer/accelerometer only to monitor/ track their physical activity step-counts for the initial 3 months. In addition, subjects will receive an educational materials on Hepatitis B and Tuberculosis. At 3 months pedometer only group will transition to receive the Filipinos Fit and Trim Weight Loss Program intervention (as previously described) for the next 3 months and complete the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in st"
11212355|NCT02278939|OG000|Outcome|Fit and Trim Intervention Group|"This groups immediately starts the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for the initial 3 months. At 3months, the Fit and Trim group transitions to a 3-month maintenance phase and completes the study at the 6-month visit.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months."
11212356|NCT02278939|OG001|Outcome|Active Control Group|"This group starts using the Fitbit accelerometer only to track physical activity step-counts for the initial 3 months. At the 3 month visit, the active control participants transition to receive the 3-month Filipinos Fit and Trim intervention and complete the study at their 6-month visit.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months."
11215508|NCT02299635|EG000|Reported Event|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
11286261|NCT02885506|OG001|Outcome|Cohort 2|"30 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212357|NCT02278939|EG000|Reported Event|Fit and Trim Group|"This groups immediately starts Filipinos Fit and Trim Weight Loss Program mobile phone intervention with social networking for the first 3 months, At 3months, the Fit and Trim group transitions to a maintenance phase for another 3 months, and completes the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months."
11212358|NCT02278939|EG001|Reported Event|Pedometer Only Group|"This group starts with a Fitbit pedometer/accelerometer only for the initial 3 months. At 3 months the pedometer only group transitions to receive the Filipinos Fit and Trim Weight Loss Program intervention ) for the next 3 months and completes the study at month 6.~Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months."
11212359|NCT02278952|BG000|Baseline|Lung Transplant Participants|Lung transplant participants treated at UCSF with tacrolimus-based immunosuppression were followed until 18 months post-transplant, or until the participant's death or withdrawal.
11212360|NCT02278952|FG000|Participant Flow|Lung Transplant Participants|Lung transplant participants treated at UCSF with tacrolimus-based immunosuppression were followed until 18 months post-transplant, or until the participant's death or withdrawal.
11212361|NCT02278952|OG000|Outcome|Non-rejection|"Blood draw samples collected at the time of bronchoscopy with biopsy. Samples included if both time points (before tacrolimus dose and 90 to 120 minutes after dose) were collected, samples provided good quality RNA, and the patient had no evidence of acute cellular rejection. Acute cellular rejection was determined based on clinical interpretation of transbronchial biopsy specimens and graded according to International Society of Heart and Lung Transplantation (ISHLT) guidelines, with non-rejection defined as A0B0."
11212362|NCT02278952|OG001|Outcome|Rejection|Transbronchial biopsy showing A>0 or B>0 pathology with no rejection defined as A = 0 in perivascular interstitial components of the lung and B = 0 in airway components of the lung.
11212363|NCT02278952|OG000|Outcome|Non-Infection|No airway infection as defined by presence of pathogenic species on bronchoalveolar lavage (BAL) culture and at least one of the following: semi-quantitative cultures with at least moderate quantity, CT findings, or symptoms consistent with acute infection.
11212364|NCT02278952|OG001|Outcome|Infection|Airway infection defined by presence of pathogenic species on BAL culture and at least one of the following: semi-quantitative cultures with at least moderate quantity, CT findings, or symptoms consistent with acute infection.
11212365|NCT02278952|OG000|Outcome|Lung Transplant Participants|Time post-transplant determined by the number of weeks between the transplant date and the date of the blood draw. Outcome measures how mean residual expression values as a function of time post-transplant.
11212366|NCT02278952|OG000|Outcome|Lung Transplant Participants|Lung transplant participants treated at UCSF with tacrolimus-based immunosuppression were followed until 18 months post-transplant, or until the participant's death or withdrawal. Tacrolimus trough levels were assayed on whole blood by the clinical lab using the Architect Immunoassay. The tacrolimus trough value closest in time to the study visit used.
11212367|NCT02278952|OG000|Outcome|Lung Transplant Participants|Lung transplant participants treated at UCSF with tacrolimus-based immunosuppression were followed until 18 months post-transplant, or until the participant's death or withdrawal. Tacrolimus, prednisone, and mycophenolate dose abstracted from medical charts at the time of blood draw.
11212368|NCT02278952|EG000|Reported Event|Lung Transplant Participants|Lung transplant participants treated at UCSF with tacrolimus-based immunosuppression were followed until 18 months post-transplant, or until the participant's death or withdrawal.
11212369|NCT02279043|BG000|Baseline|Intervention|"IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.~Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users."
11212370|NCT02279043|BG001|Baseline|Control|"Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.~Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions."
11212371|NCT02279043|BG002|Baseline|IUC Users|IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
11212372|NCT02279043|BG003|Baseline|Total|Total of all reporting groups
10820037|NCT00041392|OG000|Outcome|Magnesium|100 mg/kg magnesium
11212373|NCT02279043|FG000|Participant Flow|Intervention|"IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.~Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users."
11212374|NCT02279043|FG001|Participant Flow|Control|"Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.~Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions."
11212375|NCT02279043|FG002|Participant Flow|IUC Users|IUC users will be recruited to populate intervention groups. Interaction with IUC users will be the intervention for non-IUC users randomized to the intervention arm. IUC users will receive no intervention.
11212376|NCT02279043|OG000|Outcome|Intervention|"IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of Interaction with users of IUC and non-IUC users in the context of the online community. About 50% of participants in intervention groups will be current IUC users, and 50% will not be current IUC users.~Interaction with users of IUC and non-IUC users: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group. Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users."
11212377|NCT02279043|OG001|Outcome|Control|"Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will have interaction with non-IUC users only. There will be up to 35 control groups of 9 members each.~Interaction with non-IUC users only: Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions."
11212378|NCT02279043|EG000|Reported Event|Intervention|IUC users and non-IUC user participants randomized to the intervention arm will take part in small intervention groups in an online community called Birth Control Connect for twelve days. There will be up to 35 intervention groups with 9 members each. Non-IUC users in these groups will receive the intervention of interaction with IUC users in the context of the online community.
11212379|NCT02279043|EG001|Reported Event|Control|Participants randomized to the control arm will take part in Birth Control Connect control groups identical to those in the intervention arm, except no participants in the control arm will be current IUC users. Therefore, participants in the control arm will not have social exposure to IUC users. We will measure these participants' attitudes and behavior related to IUC use before and after the twelve-day study period, and compare results to those of participants in the intervention arm. There will be up to 35 control groups of 9 members each.
11212380|NCT02279082|BG000|Baseline|DFN-02 (Single Arm, Open Label)|"Active DFN-02~DFN-02: Active Experimental Drug"
11212381|NCT02279082|FG000|Participant Flow|DFN-02|"Active DFN-02 (Nasal Sumatriptan 10mg)~DFN-02: Active Experimental Drug"
11212382|NCT02279082|OG000|Outcome|DFN-02|"Active DFN-02~DFN-02: Active Experimental Drug"
11212383|NCT02279082|EG000|Reported Event|DFN-02 (Single Arm, Open Label)|"Active DFN-02~DFN-02: Active Experimental Drug"
11212384|NCT02279108|BG000|Baseline|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
11212385|NCT02279108|BG001|Baseline|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
10820038|NCT00041392|OG001|Outcome|0.9 % Saline|100 mg/kg 0.9 % saline
10820039|NCT00041392|EG000|Reported Event|Magnesium|100 mg/kg magnesium
10820040|NCT00041392|EG001|Reported Event|0.9 % Saline|100 mg/kg 0.9 % saline
11212386|NCT02279108|BG002|Baseline|Total|Total of all reporting groups
11212387|NCT02279108|FG000|Participant Flow|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
11212388|NCT02279108|FG001|Participant Flow|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
11212389|NCT02279108|OG000|Outcome|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
11212390|NCT02279108|OG001|Outcome|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
11286262|NCT02885506|OG002|Outcome|Cohort 3|"100 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212391|NCT02279108|EG000|Reported Event|Double Detection Indocyanine + Isotope|"intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery~indocyanine green: One injection, 2.5 milligrams per patient, intradermal use~isotope: One injection, 20 MBq techntium99, intradermal use"
11212392|NCT02279108|EG001|Reported Event|Isotope Detection Alone|"intradermal injection of 20 MBq of technetium 99 before breast surgery~isotope: One injection, 20 MBq techntium99, intradermal use"
11212393|NCT02279160|BG000|Baseline|APD811|"Multiple dose titration to maximum tolerated dose.~APD811"
11212394|NCT02279160|BG001|Baseline|Placebo|"Multiple dose titration to maximum tolerated dose.~Placebo"
11212395|NCT02279160|BG002|Baseline|Total|Total of all reporting groups
11212396|NCT02279160|FG000|Participant Flow|APD811|"Multiple dose titration to maximum tolerated dose.~APD811"
11212397|NCT02279160|FG001|Participant Flow|Placebo|"Multiple dose titration to maximum tolerated dose.~Placebo"
11212398|NCT02279160|OG000|Outcome|APD811|"Multiple dose titration to maximum tolerated dose.~APD811"
11212399|NCT02279160|OG001|Outcome|Placebo|"Multiple dose titration to maximum tolerated dose.~Placebo"
11212400|NCT02279160|EG000|Reported Event|APD811|"Multiple dose titration to maximum tolerated dose.~APD811"
11212401|NCT02279160|EG001|Reported Event|Placebo|"Multiple dose titration to maximum tolerated dose.~Placebo"
11212402|NCT02279407|BG000|Baseline|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
11212403|NCT02279407|BG001|Baseline|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
10820041|NCT00053495|BG000|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
11212404|NCT02279407|BG002|Baseline|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
11212405|NCT02279407|BG003|Baseline|Placebo|Placebo to Epanova and placebo to Dapagliflozin
11212406|NCT02279407|BG004|Baseline|Total|Total of all reporting groups
11212407|NCT02279407|FG000|Participant Flow|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
11212408|NCT02279407|FG001|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
11212409|NCT02279407|FG002|Participant Flow|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
11212410|NCT02279407|FG003|Participant Flow|Placebo|Placebo to Epanova and placebo to Dapagliflozin
11212411|NCT02279407|OG000|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
11212412|NCT02279407|OG001|Outcome|Placebo|Placebo to Epanova and placebo to Dapagliflozin
11212413|NCT02279407|OG001|Outcome|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
11212414|NCT02279407|OG002|Outcome|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
11212415|NCT02279407|EG000|Reported Event|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
11212416|NCT02279407|EG001|Reported Event|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
11212417|NCT02279407|EG002|Reported Event|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
11212418|NCT02279407|EG003|Reported Event|Placebo|Placebo to Epanova and placebo to Dapagliflozin
11212419|NCT02279420|BG000|Baseline|Essential Study Sham Cross-over|Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
11212420|NCT02279420|FG000|Participant Flow|Essential Study Sham Cross-over|Eligible sham subjects from primary study
11212421|NCT02279420|OG000|Outcome|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
11212422|NCT02279420|EG000|Reported Event|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
11212423|NCT02279498|BG000|Baseline|Liprotamase|"Individually-optimized dose to be administered orally~Liprotamase: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11212424|NCT02279498|BG001|Baseline|Porcine (Pig) PERT|"Individually-optimized dose to be administered orally~porcine (pig) PERT: oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source"
11212425|NCT02279498|BG002|Baseline|Total|Total of all reporting groups
11212426|NCT02279498|FG000|Participant Flow|Liprotamase|"Individually-optimized dose to be administered orally~Liprotamase: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11212427|NCT02279498|FG001|Participant Flow|Porcine (Pig) PERT|"Individually-optimized dose to be administered orally~porcine (pig) PERT: oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source"
11212428|NCT02279498|OG000|Outcome|Treatment Difference|analysed as LS mean difference in change in CFA from baseline for Liprotamase - Porcine enzymes
11212429|NCT02279498|OG000|Outcome|Liprotamase|"Individually-optimized dose to be administered orally~Liprotamase: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11212430|NCT02279498|OG001|Outcome|Porcine (Pig) PERT|"Individually-optimized dose to be administered orally~porcine (pig) PERT: oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source"
11212431|NCT02279498|EG000|Reported Event|Liprotamase|"Individually-optimized dose to be administered orally~Liprotamase: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11212432|NCT02279498|EG001|Reported Event|Porcine (Pig) PERT|"Individually-optimized dose to be administered orally~porcine (pig) PERT: oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source"
11212433|NCT02279524|BG000|Baseline|Aramchol 600mg|One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
11212434|NCT02279524|BG001|Baseline|Aramchol 400mg|One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
11212435|NCT02279524|BG002|Baseline|Placebo|Two tablet of Aramchol matching placebo.
11212436|NCT02279524|BG003|Baseline|Total|Total of all reporting groups
11212437|NCT02279524|FG000|Participant Flow|Aramchol 600mg|One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg, once a day for 52 weeks
11212438|NCT02279524|FG001|Participant Flow|Aramchol 400mg|One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol, once a day for 52 weeks
11212439|NCT02279524|FG002|Participant Flow|Placebo|Two tablets of matching placebo for Aramchol, once a day for 52 weeks
11212440|NCT02279524|OG000|Outcome|Aramchol 600mg|One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
11212441|NCT02279524|OG001|Outcome|Aramchol 400mg|One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
11212442|NCT02279524|OG002|Outcome|Placebo|Two tablet of Aramchol matching placebo.
11212443|NCT02279524|EG000|Reported Event|Aramchol 600mg|One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
11212444|NCT02279524|EG001|Reported Event|Aramchol 400mg|One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
11212445|NCT02279524|EG002|Reported Event|Placebo|Two tablet of Aramchol matching placebo.
11212446|NCT02279641|BG000|Baseline|Sequence A|Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
11212447|NCT02279641|BG001|Baseline|Sequence B|Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
11212448|NCT02279641|BG002|Baseline|Total|Total of all reporting groups
11212449|NCT02279641|FG000|Participant Flow|RDEA3170 or Allopurinol Alone and in Combination (Sequence A)|Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol
11212450|NCT02279641|FG001|Participant Flow|RDEA3170 or Allopurinol Alone and in Combination (Sequence B)|Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
11212451|NCT02279641|OG000|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
11212452|NCT02279641|OG001|Outcome|Allopurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212453|NCT02279641|OG002|Outcome|Oxypurinol: Allopurinol Alone|Allopurinol 300 mg qd
11212454|NCT02279641|OG003|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212455|NCT02279641|OG004|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
11212456|NCT02279641|OG005|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212457|NCT02279641|OG004|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212458|NCT02279641|OG000|Outcome|RDEA3170: RDEA3170 Alone|RDEA3170 10 mg qd
11212459|NCT02279641|OG001|Outcome|Oxypurinol: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212460|NCT02279641|OG002|Outcome|Allopurinol: Allopurinol Alone|Allopurinol 300 mg qd
11212461|NCT02279641|OG001|Outcome|RDEA3170: RDEA3170 + Allopurinol|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212462|NCT02279641|EG000|Reported Event|RDEA3170 10 mg qd|RDEA3170 10 mg qd
11212463|NCT02279641|EG001|Reported Event|RDEA3170 10 mg qd + Allopurinol 300 mg qd|RDEA3170 10 mg qd + Allopurinol 300 mg qd
11212464|NCT02279641|EG002|Reported Event|Allopurinol 300 mg qd|Allopurinol 300 mg qd
11212465|NCT02279667|BG000|Baseline|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
11212466|NCT02279667|BG001|Baseline|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
11212467|NCT02279667|BG002|Baseline|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
11212468|NCT02279667|BG003|Baseline|Total|Total of all reporting groups
11212469|NCT02279667|FG000|Participant Flow|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
11212470|NCT02279667|FG001|Participant Flow|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
11212471|NCT02279667|FG002|Participant Flow|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
11212472|NCT02279667|OG000|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
11212473|NCT02279667|OG001|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
11212474|NCT02279667|OG002|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
11212475|NCT02279667|EG000|Reported Event|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
11212476|NCT02279667|EG001|Reported Event|BIA 2-093 - Four 200 mg Tablets|BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
11212477|NCT02279667|EG002|Reported Event|BIA 2-093 One 800 mg Tablet|BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
11212478|NCT02279667|EG003|Reported Event|Follow-up|Follow-up.
11212479|NCT02279732|BG000|Baseline|Ipi + PAC/CAR|Ipilumumab + paclitaxel/Carboplatin
11212480|NCT02279732|BG001|Baseline|Placebo + PAC/CAR|Placebo + Carboplatin/Paclitaxel
11212481|NCT02279732|BG002|Baseline|Total|Total of all reporting groups
11212482|NCT02279732|FG000|Participant Flow|Ipi + PAC/CAR|Ipilumumab + paclitaxel/Carboplatin
11212483|NCT02279732|FG001|Participant Flow|Placebo + PAC/CAR|Placebo + Carboplatin/Paclitaxel
11212484|NCT02279732|OG000|Outcome|Ipi + PAC/CAR|Ipilumumab + paclitaxel/Carboplatin
11212485|NCT02279732|OG001|Outcome|Placebo + PAC/CAR|Placebo + Carboplatin/Paclitaxel
11212486|NCT02279732|EG000|Reported Event|Ipi + PAC/CAR|Ipilumumab + paclitaxel/Carboplatin
11212487|NCT02279732|EG001|Reported Event|Placebo + PAC/CAR|Placebo + Carboplatin/Paclitaxel
11212488|NCT02279862|BG000|Baseline|Ipilimumab 3 mg/kg|Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212489|NCT02279862|BG001|Baseline|Ipilimumab 10 mg/kg|Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212490|NCT02279862|BG002|Baseline|Total|Total of all reporting groups
11212491|NCT02279862|FG000|Participant Flow|Ipilimumab 3 mg/kg|Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212492|NCT02279862|FG001|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212493|NCT02279862|OG000|Outcome|Ipilimumab 3 mg/kg|Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212494|NCT02279862|OG001|Outcome|Ipilimumab 10 mg/kg|Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212495|NCT02279862|EG000|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab at 10 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212496|NCT02279862|EG001|Reported Event|3 MG/KG IPILIMUMAB|Ipilimumab at 3 mg/kg was administered by intravenous (IV) infusion over a time period of 60-100 minutes, based on body weight. Induction Phase dosing consisted of a single dose every 3 weeks (Q3W) for 4 doses. This was followed by Maintenance Phase dosing of a single dose every 12 weeks (Q12W). Treatment was for a maximum treatment period of 3 years from the first induction dose of blinded study therapy, or until subject met treatment stopping criteria.
11212497|NCT02280044|BG000|Baseline|Rifaximin|Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
11212498|NCT02280044|BG001|Baseline|Placebo|Subjects receiving placebo will be challenged with C. jejuni
11212499|NCT02280044|BG002|Baseline|Total|Total of all reporting groups
11212500|NCT02280044|FG000|Participant Flow|Rifaximin|Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
11212501|NCT02280044|FG001|Participant Flow|Placebo|Subjects receiving placebo will be challenged with C. jejuni
11212502|NCT02280044|OG000|Outcome|Rifaximin|Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
11212503|NCT02280044|OG001|Outcome|Placebo|Subjects receiving placebo will be challenged with C. jejuni
11212504|NCT02280044|EG000|Reported Event|Rifaximin|Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
11212505|NCT02280044|EG001|Reported Event|Placebo|Subjects receiving placebo will be challenged with C. jejuni
11212506|NCT02280096|BG000|Baseline|4-aminopyridine Treatment (20 Weeks)|4-aminopyridine is given as gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as the excipient. Each patient will take two capsules every 8 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.
11212507|NCT02280096|BG001|Baseline|Placebo (20 Weeks)|"Patients randomized to the placebo sequence will receive placebo for 20 weeks after the run-in period. They will be blinded to the fact that they are taking placebo, and capsules will be identical in appearance to the intervention capsules.~Placebo: The placebo arm will include Microcrystalline Cellulose placebo"
11212508|NCT02280096|BG002|Baseline|Total|Total of all reporting groups
11212509|NCT02280096|FG000|Participant Flow|4-aminopyridine Treatment|"4-aminopyridine is given as gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as the excipient. Each patient will take two capsules every 6 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.~4-aminopyridine: Each patient will take two capsules every 6 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study."
11212510|NCT02280096|FG001|Participant Flow|Placebo|"Patients randomized to the placebo sequence will receive placebo for 20 weeks after the run-in period. They will be blinded to the fact that they are taking placebo, and capsules will be identical in appearance to the intervention capsules.~Placebo: The placebo arm will include Microcrystalline Cellulose placebo"
11212511|NCT02280096|OG000|Outcome|4-aminopyridine|The mean dose provided to the patients was 0.63 ± 0.05 mg per kg of body weight.
11212512|NCT02280096|OG001|Outcome|Placebo|Identical placebo capsules administered for 22 weeks.
11212513|NCT02280096|OG001|Outcome|Placebo|Identical placebo capsules administered for 22 weeks
11212514|NCT02280096|OG000|Outcome|4-aminopyridine|The dose provided to the patients was 0.63 ± 0.05 mg per kg of body weight.
11212515|NCT02280096|OG001|Outcome|Placebo|Identical placebo capsules were administered
11212516|NCT02280096|OG000|Outcome|4-aminopirydine|The mean dose provided to the patients was 0.63 ± 0.05 mg per kg of body weight.
11212517|NCT02280096|OG000|Outcome|4-aminopyridine Treatment|4-aminopyridine is given as gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as the excipient. Each patient will take two capsules every 8 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.
11212518|NCT02280096|OG001|Outcome|Placebo|"Patients randomized to the placebo sequence will receive placebo for 20 weeks after the run-in period. They will be blinded to the fact that they are taking placebo, and capsules will be identical in appearance to the intervention capsules.~Placebo: The placebo arm will include Microcrystalline Cellulose placebo"
11212519|NCT02280096|OG000|Outcome|4-aminopyridine|20 weeks administration of 4-aminopyridine. The mean dose provided to the patients was 0.63 ± 0.05 mg per kg of body weight.
11212520|NCT02280096|OG001|Outcome|Placebo|Identical placebo tablet administered bid for 20 weeks
11212521|NCT02280096|OG000|Outcome|4-aminopyridine Treatment|4-aminopyridine is given as gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as the excipient. Each patient will take two capsules every 8 hours after meals, for a total of 8 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.
11212522|NCT02280096|EG000|Reported Event|4-aminopyridine|22 weeks administration of 4-aminopyridine. The mean dose provided to the patients was 0.63 ± 0.05 mg per kg of body weight.
11212523|NCT02280096|EG001|Reported Event|Placebo|Identical placebo tablet administered bid for 20 weeks
11212524|NCT02280122|BG000|Baseline|Generalised Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212525|NCT02280122|BG001|Baseline|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212526|NCT02280122|BG002|Baseline|Total|Total of all reporting groups
11212527|NCT02280122|FG000|Participant Flow|Moderate Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212528|NCT02280122|FG001|Participant Flow|Severe Chronic Periodontitis|"Sites with probing PPD ≥ 3.5 mm~PAL-V ≥ 5 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212529|NCT02280122|FG002|Participant Flow|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212530|NCT02280122|OG000|Outcome|Sensitivity: Generalised Moderate/Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212531|NCT02280122|OG001|Outcome|Specificity: Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212532|NCT02280122|EG000|Reported Event|Generalized Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212533|NCT02280122|EG001|Reported Event|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
11212534|NCT02280187|BG000|Baseline|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
11212535|NCT02280187|FG000|Participant Flow|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
11212536|NCT02280187|OG000|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
11212537|NCT02280187|EG000|Reported Event|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
11212538|NCT02280200|BG000|Baseline|AFO to Improve Outcomes|"open label, non-interventional design (all patients who volunteer for trial receive AFO)~AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes."
11212539|NCT02280200|BG001|Baseline|Historical Controls|Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
11212540|NCT02280200|BG002|Baseline|Total|Total of all reporting groups
11212541|NCT02280200|FG000|Participant Flow|AFO to Improve Outcomes|Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
11212542|NCT02280200|FG001|Participant Flow|Historical Controls|Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
11212543|NCT02280200|OG000|Outcome|AFO to Improve Outcomes|"open label, non-interventional design (all patients who volunteer for trial receive AFO)~AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes."
11212544|NCT02280200|OG001|Outcome|Historical Controls|Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
11212545|NCT02280200|EG000|Reported Event|AFO to Improve Outcomes|"Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum~AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes."
11212546|NCT02280200|EG001|Reported Event|Historical Controls|Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
11212547|NCT02280226|BG000|Baseline|Deliberate Apnea Group|"Subjects undergo maximum apnea.~magnetic resonance imaging (MRI)"
11212548|NCT02280226|FG000|Participant Flow|Deliberate Apnea Group|
11212549|NCT02280226|OG000|Outcome|Deliberate Apnea Group|"Subjects undergo maximum apnea.~magnetic resonance imaging (MRI)"
11212550|NCT02280226|EG000|Reported Event|Deliberate Apnea Group|Subjects undergo maximum apnea and magnetic resonance imaging (MRI) was performed.
11212551|NCT02280291|BG000|Baseline|Ankle Single Shot Block (SSB)|Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212552|NCT02280291|BG001|Baseline|Ankle OnQ (Continuos Sedation OnQ Pump)|Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212553|NCT02280291|BG002|Baseline|DR SSB|DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212554|NCT02280291|BG003|Baseline|DR OnQ|DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212555|NCT02280291|BG004|Baseline|Total|Total of all reporting groups
11212556|NCT02280291|FG000|Participant Flow|Ankle Single Shot Block (SSB)|Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212557|NCT02280291|FG001|Participant Flow|Ankle OnQ (Continuos Sedation OnQ Pump)|Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212558|NCT02280291|FG002|Participant Flow|DR SSB|DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212559|NCT02280291|FG003|Participant Flow|DR OnQ|DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212560|NCT02280291|OG000|Outcome|Ankle Single Shot Block (SSB)|Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212561|NCT02280291|OG001|Outcome|Ankle OnQ (Continuos Sedation OnQ Pump)|Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212562|NCT02280291|OG002|Outcome|DR SSB|DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212563|NCT02280291|OG003|Outcome|DR OnQ|DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212564|NCT02280291|OG000|Outcome|DR SSB|DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
10820042|NCT00053495|BG001|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
11212565|NCT02280291|OG001|Outcome|DR OnQ|DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212566|NCT02280291|EG000|Reported Event|Ankle Single Shot Block (SSB)|Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212567|NCT02280291|EG001|Reported Event|Ankle OnQ (Continuos Sedation OnQ Pump)|Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212568|NCT02280291|EG002|Reported Event|DR SSB|DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
11212569|NCT02280291|EG003|Reported Event|DR OnQ|DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
11212570|NCT02280304|BG000|Baseline|Inner Resources for Veterans Meditation and Mantra Therapy|"Participants complete meditation and mantra therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212571|NCT02280304|BG001|Baseline|Essential Skills Therapy|Participants learn about symptoms of PTSD and mTBI and coping skills for PTSD.
11212572|NCT02280304|BG002|Baseline|Total|Total of all reporting groups
11212573|NCT02280304|FG000|Participant Flow|Inner Resources for Veterans Meditation Therapy|"Participants will complete meditation therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212574|NCT02280304|FG001|Participant Flow|PTSD and mTBI Education|"Participants will learn about symptoms and triggers of PTSD and mTBI~PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI"
11212575|NCT02280304|OG000|Outcome|Inner Resources for Veterans (IRV) Mindfulness and Mantra|"Participants will complete meditation and mantra therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212576|NCT02280304|OG001|Outcome|Essential Skills Therapy|"Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD~PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI"
11212577|NCT02280304|OG000|Outcome|Inner Resources for Veterans (IRV) Mindfulness and Mantra|"Participants will complete meditation therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212578|NCT02280304|OG000|Outcome|Essential Skills Therapy|"Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD~PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI"
11212579|NCT02280304|OG001|Outcome|Inner Resources for Veterans (IRV) Mindfulness and Mantra|"Participants will complete meditation therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212580|NCT02280304|OG001|Outcome|Essential Skills Therapy|Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD.
11212581|NCT02280304|OG000|Outcome|Inner Resources for Veterans (IRV) Mindfulness and Mantra|Meditation and mantra therapy
11212582|NCT02280304|OG001|Outcome|Essential Skills Therapy|Control therapy involving learning about PTSD and mTBI symptoms and coping information.
11212583|NCT02280304|OG000|Outcome|Combined Groups (IRV + ES)|Groups were combined to increase range of the sample size and to examine the general effect of therapy. Subjects (n=16; 9 IRV and 7 ES) were those who had both a post-therapy scan (regardless of therapy, IRV or ES) and CRIS-CAT scores prior to therapy. Analysis: Pre-therapy scores were regressed onto post-therapy functional connectivity, relative to pre-therapy functional connectivity (Post-Pre).
11212584|NCT02280304|EG000|Reported Event|Inner Resources for Veterans Meditation Therapy|"Participants will complete meditation therapy~Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment"
11212585|NCT02280304|EG001|Reported Event|PTSD and mTBI Education|"Participants will learn about symptoms and triggers of PTSD and mTBI~PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI"
11212586|NCT02280317|BG000|Baseline|Cohort 1: 0.5 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
11212587|NCT02280317|BG001|Baseline|Cohort 2: 1 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
11212588|NCT02280317|BG002|Baseline|Cohort 3: 2 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
11212589|NCT02280317|BG003|Baseline|Cohort 4: 4 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
11212590|NCT02280317|BG004|Baseline|Cohort 5: up to 8 mg/kg|VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
11212591|NCT02280317|BG005|Baseline|Total|Total of all reporting groups
11212592|NCT02280317|FG000|Participant Flow|Cohort 1: 0.5 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 0.5mg/kg.
11212593|NCT02280317|FG001|Participant Flow|Cohort 2: 1.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
11212594|NCT02280317|FG002|Participant Flow|Cohort 3: 2.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg
11212595|NCT02280317|FG003|Participant Flow|Cohort 4: 4.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg
11244504|NCT02511717|BG000|Baseline|Sham|"Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks~Sham transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244505|NCT02511717|BG001|Baseline|Transcutaneous Nerve Stimulation|"Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks~Transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244506|NCT02511717|BG002|Baseline|Total|Total of all reporting groups
11244507|NCT02511717|FG000|Participant Flow|Sham|"Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks~Sham transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244508|NCT02511717|FG001|Participant Flow|Transcutaneous Nerve Stimulation|"Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks~Transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244509|NCT02511717|OG000|Outcome|Sham|"Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks~Sham transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244510|NCT02511717|OG001|Outcome|Transcutaneous Nerve Stimulation|"Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks~Transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244511|NCT02511717|EG000|Reported Event|Sham|"Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks~Sham transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244512|NCT02511717|EG001|Reported Event|Transcutaneous Nerve Stimulation|"Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks~Transcutaneous tibial nerve stimulation: Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks."
11244513|NCT02511730|BG000|Baseline|All 100 Cases/Study Participants|Each case contributed 2 sets of images: FFDM only as well as DBT plus FFDM. Therefore there were 200 reads acquired from the 100 cases/participants.
11244514|NCT02511730|FG000|Participant Flow|FFDM Plus DBT, Then FFDM Only|Readers to read half of the FFDM plus DBT images followed by half of the FFDM only images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.
11244515|NCT02511730|FG001|Participant Flow|FFDM Only, Then FFDM Plus DBT|Readers to read half of the FFDM only images followed by half of the FFDM plus DBT images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.
11244516|NCT02511730|OG000|Outcome|FFDM Plus DBT|"Breast Images with FFDM and DBT~FFDM Plus DBT: Fujifilm Aspire Cristalle System"
11244517|NCT02511730|OG001|Outcome|FFDM|"Breast Images with FFDM alone~FFDM: Fujifilm Aspire Cristalle System"
11244518|NCT02511730|EG000|Reported Event|FFDM Plus DBT|"Breast Images with FFDM and DBT~FFDM Plus DBT: Fujifilm Aspire Cristalle System"
11244519|NCT02511730|EG001|Reported Event|FFDM|"Breast Images with FFDM alone~FFDM: Fujifilm Aspire Cristalle System"
10820043|NCT00053495|BG002|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
11244520|NCT02511782|BG000|Baseline|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244521|NCT02511782|BG001|Baseline|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244522|NCT02511782|BG002|Baseline|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244523|NCT02511782|BG003|Baseline|Total|Total of all reporting groups
11244524|NCT02511782|FG000|Participant Flow|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244525|NCT02511782|FG001|Participant Flow|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244526|NCT02511782|FG002|Participant Flow|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244527|NCT02511782|OG000|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244528|NCT02511782|OG001|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244529|NCT02511782|OG002|Outcome|Chronic Graft Versus Host Disease|This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease.
11244530|NCT02511782|EG000|Reported Event|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11286263|NCT02885506|OG003|Outcome|Cohort 4|"250 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212596|NCT02280317|FG004|Participant Flow|Cohort 5: Up to 8.0 mg/kg|VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
10820044|NCT00053495|BG003|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
11212597|NCT02280317|OG000|Outcome|Cohort 1: 0.5 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
11212598|NCT02280317|OG001|Outcome|Cohort 2: 1.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
11212599|NCT02280317|OG002|Outcome|Cohort 3: 2.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
11212600|NCT02280317|OG003|Outcome|Cohort 4: 4.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
11212601|NCT02280317|OG004|Outcome|Cohort 5: up to 8 mg/kg|VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
11212602|NCT02280317|OG000|Outcome|Cohort 5: up to 8.0 mg/kg|VAL201 Sub-cutaneous injection. 8.0 mg/kg
11212603|NCT02280317|OG001|Outcome|Cohort 5: up to 8 mg/kg|VAL201 Sub-cutaneous injection 4 mg/kg
11212604|NCT02280317|OG000|Outcome|Cohort 5: up to 8 mg/kg AUC|VAL201 Sub-cutaneous injection 8.0 mg/kg
11212605|NCT02280317|OG001|Outcome|Cohort 5: Up to 8 mg/kg|VAL201 Sub-cutaneous injection 4.0 mg/kg
11212606|NCT02280317|OG000|Outcome|Cohort 1: 0.5 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg
11212607|NCT02280317|OG001|Outcome|Cohort 2: 1.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg
11212608|NCT02280317|OG002|Outcome|Cohort 3: 2.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg
11212609|NCT02280317|OG003|Outcome|Cohort 4: 4.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg
11212610|NCT02280317|OG004|Outcome|Cohort 5: up to 8.0 mg/kg|"VAL201: VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision.~Flexibility of dosing enabled under protocol."
11212611|NCT02280317|OG004|Outcome|Cohort 5: up to 8.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
11212612|NCT02280317|EG000|Reported Event|Cohort 1: 0.5 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
11212613|NCT02280317|EG001|Reported Event|Cohort 2: 1.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
11212614|NCT02280317|EG002|Reported Event|Cohort 3: 2.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
11212615|NCT02280317|EG003|Reported Event|Cohort 4: 4.0 mg/kg|VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
11212616|NCT02280317|EG004|Reported Event|Cohort 5: up to 8 mg/kg (8 mg/kg)|"VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.~This patient received 8 mg/kg"
11212617|NCT02280317|EG005|Reported Event|Cohort 5: up to 8 mg/kg (4 mg/kg)|"VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.~This patient received 4 mg/kg"
11212618|NCT02280408|BG000|Baseline|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28.
11212619|NCT02280408|BG001|Baseline|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
11212620|NCT02280408|BG002|Baseline|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28.
11212621|NCT02280408|BG003|Baseline|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28.
11212622|NCT02280408|BG004|Baseline|Total|Total of all reporting groups
11212623|NCT02280408|FG000|Participant Flow|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28.
11212624|NCT02280408|FG001|Participant Flow|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
11212625|NCT02280408|FG002|Participant Flow|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28.
11212626|NCT02280408|FG003|Participant Flow|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28.
11212627|NCT02280408|OG000|Outcome|3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28.
11212628|NCT02280408|OG001|Outcome|2x10^7 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
11212629|NCT02280408|OG002|Outcome|1x10^8 Pfu Vaccine Cohort|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28.
11212630|NCT02280408|OG003|Outcome|Placebo Cohort|Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28.
11212631|NCT02280408|EG000|Reported Event|3x106 Pfu V920|Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28.
11212632|NCT02280408|EG001|Reported Event|2x107 Pfu V920|Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
11212633|NCT02280408|EG002|Reported Event|1x108 Pfu V920|Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28.
11212634|NCT02280408|EG003|Reported Event|Placebo|Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28.
11212635|NCT02280421|BG000|Baseline|ASP2151 400mg|"ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin first, then ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin"
11212636|NCT02280421|BG001|Baseline|ASP2151 1200mg|"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin first, then ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
11212637|NCT02280421|BG002|Baseline|Total|Total of all reporting groups
11212638|NCT02280421|FG000|Participant Flow|ASP2151 400mg|"ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin first, then ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin"
11244531|NCT02511782|EG001|Reported Event|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244532|NCT02511782|EG002|Reported Event|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
11244533|NCT02512042|BG000|Baseline|Generic Brinzolamide 1% Ophthalmic Suspension|Study subjects used one drop in both eyes three times daily for 42 days.
11244534|NCT02512042|BG001|Baseline|Azopt® 1% Ophthalmic Suspension|Study subjects used one drop in both eyes three times daily for 42 days.
11244535|NCT02512042|BG002|Baseline|Total|Total of all reporting groups
11244536|NCT02512042|FG000|Participant Flow|Generic Brinzolamide Ophthalmic Suspension USP 1%|Study subjects used one drop in both eyes three times daily for 42 days.
11244537|NCT02512042|FG001|Participant Flow|Azopt® (Brinzolomide Ophthalmic Suspension USP 1%)|Study subjects used one drop in both eyes three times daily for 42 days.
11244538|NCT02512042|OG000|Outcome|Generic Brinzolamide Ophthalmic Suspension USP 1%|Study subjects used one drop in both eyes three times daily for 42 days.
11244539|NCT02512042|OG001|Outcome|Azopt® (Brinzolomide Ophthalmic Suspension USP 1%)|Study subjects used one drop in both eyes three times daily for 42 days.
11244540|NCT02512042|EG000|Reported Event|Generic Brinzolamide 1% Ophthalmic Suspension|Study subjects used one drop in both eyes three times daily for 42 days.
11244541|NCT02512042|EG001|Reported Event|Azopt® 1% Ophthalmic Suspension|Study subjects used one drop in both eyes three times daily for 42 days.
11244542|NCT02512068|BG000|Baseline|Trelagliptin 25 mg|Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)
11244543|NCT02512068|BG001|Baseline|Placebo and Trelagliptin 25 mg|Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
11244544|NCT02512068|BG002|Baseline|Total|Total of all reporting groups
11244545|NCT02512068|FG000|Participant Flow|Trelagliptin 25 mg|Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)
11244546|NCT02512068|FG001|Participant Flow|Placebo and Trelagliptin 25 mg|Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
11244547|NCT02512068|OG000|Outcome|Trelagliptin 25 mg|Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)
11244548|NCT02512068|OG001|Outcome|Placebo and Trelagliptin 25 mg|Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
11244549|NCT02512068|EG000|Reported Event|Trelagliptin 25 mg|Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)
11244550|NCT02512068|EG001|Reported Event|Placebo and Trelagliptin 25 mg|Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
11244551|NCT02512094|BG000|Baseline|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
11244552|NCT02512094|FG000|Participant Flow|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
11244553|NCT02512094|OG000|Outcome|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
11244554|NCT02512094|EG000|Reported Event|Elderly Hip Fracture|Age at least 50 years old Hip fractures within 2 weeks since injury
11244555|NCT02512224|BG000|Baseline|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244556|NCT02512224|BG001|Baseline|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244557|NCT02512224|BG002|Baseline|Total|Total of all reporting groups
11244558|NCT02512224|FG000|Participant Flow|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244559|NCT02512224|FG001|Participant Flow|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244560|NCT02512224|OG000|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10820045|NCT00053495|BG004|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820046|NCT00053495|BG005|Baseline|Total|Total of all reporting groups
10820047|NCT00053495|FG000|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820048|NCT00053495|FG001|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
10820049|NCT00053495|FG002|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
10820050|NCT00053495|FG003|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
10820051|NCT00053495|FG004|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820052|NCT00053495|OG000|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
11244561|NCT02512224|OG001|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244562|NCT02512224|EG000|Reported Event|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10820053|NCT00053495|OG001|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
10820054|NCT00053495|OG002|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
10820055|NCT00053495|OG003|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
10820056|NCT00053495|OG004|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820057|NCT00053495|EG000|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820058|NCT00053495|EG001|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
10820059|NCT00053495|EG002|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
10820060|NCT00053495|EG003|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
10820061|NCT00053495|EG004|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
10820062|NCT00053677|BG000|Baseline|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
10820063|NCT00053677|BG001|Baseline|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
10820064|NCT00053677|BG002|Baseline|Total|Total of all reporting groups
10820065|NCT00053677|FG000|Participant Flow|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
10820066|NCT00053677|FG001|Participant Flow|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
10820067|NCT00053677|OG000|Outcome|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
10820068|NCT00053677|OG001|Outcome|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
10820069|NCT00053677|EG000|Reported Event|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
10820070|NCT00053677|EG001|Reported Event|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
10820071|NCT00053703|BG000|Baseline|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
11286264|NCT02885506|OG004|Outcome|Cohort 5|"500 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212639|NCT02280421|FG001|Participant Flow|ASP2151 1200mg|"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin first, then ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
11212640|NCT02280421|OG000|Outcome|ASP2151 400mg Alone|ASP2151(400mg) alone
11212641|NCT02280421|OG001|Outcome|ASP2151 400mg With Ciclosporin|"ASP2151 400mg + 100mg ciclosporin~ASP2151 400mg + 100mg ciclosporin"
11212642|NCT02280421|OG002|Outcome|ASP2151 1200mg Alone|ASP2151(1200mg) alone
11212643|NCT02280421|OG003|Outcome|ASP2151 1200mg With Ciclosporin|"ASP2151 1200mg + 100mg ciclosporin~ASP2151 1200mg + 100mg ciclosporin"
11212644|NCT02280421|OG000|Outcome|400 mg ASP Treatment|400 mg ASP Treatment
11212645|NCT02280421|OG001|Outcome|1200 mg ASP Treatment|1200 mg ASP Treatment
11212646|NCT02280421|OG000|Outcome|Ciclosporin After ASP2151(400mg)|Ciclosporin after ASP2151(400mg)
11212647|NCT02280421|OG001|Outcome|Ciclosporin With ASP2151(400mg)|Ciclosporin with ASP2151(400mg)
11212648|NCT02280421|OG002|Outcome|Ciclosporin After ASP2151(1200mg)|Ciclosporin after ASP2151(1200mg)
11212649|NCT02280421|OG003|Outcome|Ciclosporin With ASP2151(1200mg)|Ciclosporin with ASP2151(1200mg)
11212650|NCT02280421|EG000|Reported Event|ASP2151(400mg) Alone|Participants who administered ASP2151 alone during the treatment session 1(ASP2151 400mg)
11212651|NCT02280421|EG001|Reported Event|Ciclosporin After ASP2151(400mg)|Participants who administered ciclosporin alone during the treatment session 1(ASP2151 400mg)
10820072|NCT00053703|BG001|Baseline|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
11212652|NCT02280421|EG002|Reported Event|Ciclosporin With ASP2151(400mg)|Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 400mg)
11212653|NCT02280421|EG003|Reported Event|ASP2151(1200mg) Alone|Participants who administered ASP2151 alone during the treatment session 1(ASP2151 1200mg)
11212654|NCT02280421|EG004|Reported Event|Ciclosporin After ASP2151(1200mg)|Participants who administered ciclosporin alone during the treatment session 1(ASP2151 1200mg)
11212655|NCT02280421|EG005|Reported Event|Ciclosporin With ASP2151(1200mg)|Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 1200mg)
11212656|NCT02280473|BG000|Baseline|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212657|NCT02280473|BG001|Baseline|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212658|NCT02280473|BG002|Baseline|Total|Total of all reporting groups
11212659|NCT02280473|FG000|Participant Flow|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212660|NCT02280473|FG001|Participant Flow|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212661|NCT02280473|OG000|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212662|NCT02280473|OG001|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212663|NCT02280473|EG000|Reported Event|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212664|NCT02280473|EG001|Reported Event|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
11212665|NCT02280499|BG000|Baseline|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
11212666|NCT02280499|FG000|Participant Flow|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
11212667|NCT02280499|OG000|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
11212668|NCT02280499|EG000|Reported Event|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
11212669|NCT02280655|BG000|Baseline|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
11212670|NCT02280655|BG001|Baseline|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
11212671|NCT02280655|BG002|Baseline|Total|Total of all reporting groups
11212672|NCT02280655|FG000|Participant Flow|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
11212673|NCT02280655|FG001|Participant Flow|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
11212674|NCT02280655|OG000|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
11212675|NCT02280655|OG001|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
11212676|NCT02280655|EG000|Reported Event|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
11212677|NCT02280655|EG001|Reported Event|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
11212678|NCT02280811|BG000|Baseline|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212679|NCT02280811|BG001|Baseline|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212680|NCT02280811|BG002|Baseline|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212681|NCT02280811|BG003|Baseline|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212682|NCT02280811|BG004|Baseline|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212683|NCT02280811|BG005|Baseline|Total|Total of all reporting groups
11212684|NCT02280811|FG000|Participant Flow|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212685|NCT02280811|FG001|Participant Flow|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212686|NCT02280811|FG002|Participant Flow|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11215509|NCT02299791|BG000|Baseline|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
11244563|NCT02512224|EG001|Reported Event|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
11244564|NCT02512276|BG000|Baseline|Telepharmacist Intervention|"Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control.~Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes."
11244565|NCT02512276|BG001|Baseline|Usual Care|Patients randomized to this arm will receive usual care.
11244566|NCT02512276|BG002|Baseline|Total|Total of all reporting groups
11244567|NCT02512276|FG000|Participant Flow|Telepharmacist Intervention|"Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control.~Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes."
11244568|NCT02512276|FG001|Participant Flow|Usual Care|Patients randomized to this arm will receive usual care.
11244569|NCT02512276|OG000|Outcome|Telepharmacist Intervention|"Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control.~Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes."
11244570|NCT02512276|OG001|Outcome|Usual Care|Patients randomized to this arm will receive usual care.
11244571|NCT02512276|EG000|Reported Event|Telepharmacist Intervention|"Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control.~Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes."
11244572|NCT02512276|EG001|Reported Event|Usual Care|Patients randomized to this arm will receive usual care.
11244573|NCT02512302|BG000|Baseline|Total|Total number of participants from all treatment groups
11244574|NCT02512302|FG000|Participant Flow|Treatment Group One|Participants received Seebri Breezhaler with activated charcoal 63 mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via e flow nebulizer; Seebri Breezhaler 63 mcg for each of the five treatment periods
11244575|NCT02512302|FG001|Participant Flow|Treatment Group Two|Participants received SUN-101 50 mcg via eFlow nebulizer, SUN-101 50 mcg via eFlow nebulier with activated charcoal; Seebri Breezhaler 63 mcg, Seebri Breezhaler 63 mcg with activated charcoal; Glycopyrrolate injection via IV infusion for each of the five treatment periods
11244576|NCT02512302|FG002|Participant Flow|Treatment Group Three|Participants recveived SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg; SUN-101 50mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; Seebri Breezerhaler 63mcg with activated charcoal for each of the five treatment periods
11244577|NCT02512302|FG003|Participant Flow|Treatment Group Four|Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods
11244578|NCT02512302|FG004|Participant Flow|Treatment Group Five|Participants received Seebri Breezhaler 63mcg ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; for each of the five treatment periods
11244579|NCT02512302|FG005|Participant Flow|Treatment Group Six|Participants received Seebri Breezhaler 63mcg with activated charcoal ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods
11244580|NCT02512302|FG006|Participant Flow|Treatment Group Seven|Participants received Seebri Breezhaler 63mcg ; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal for each of the five treatment periods
11244581|NCT02512302|FG007|Participant Flow|Treatment Group Eight|Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63 mcg; Glycopyrrolate injection via IV infusion for each of the five treatment periods
11212687|NCT02280811|FG003|Participant Flow|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212688|NCT02280811|FG004|Participant Flow|HPV-16 E6 mTCR PBL MTD + HD IL-2|"This is the phase 2 arm that was treated at the MTD determined in the phase 1 portion.~patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212689|NCT02280811|OG000|Outcome|All Treated Subjects|All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10^9, 1x10^10,1x10^11, >1x10^11 up to 2x10^11 + high-dose (HD) interleukin 2 (IL-2) were included.
11212690|NCT02280811|OG000|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212691|NCT02280811|OG001|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212692|NCT02280811|OG002|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212693|NCT02280811|OG003|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212694|NCT02280811|OG004|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212695|NCT02280811|EG000|Reported Event|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212696|NCT02280811|EG001|Reported Event|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11215510|NCT02299791|BG001|Baseline|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
11215511|NCT02299791|BG002|Baseline|Total|Total of all reporting groups
10820073|NCT00053703|BG002|Baseline|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
11212697|NCT02280811|EG002|Reported Event|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212698|NCT02280811|EG003|Reported Event|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212699|NCT02280811|EG004|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212700|NCT02280811|EG005|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin~Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.~Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days~E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
11212701|NCT02280863|BG000|Baseline|Adult Cohort|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212702|NCT02280863|BG001|Baseline|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212703|NCT02280863|BG002|Baseline|Total|Total of all reporting groups
11212704|NCT02280863|FG000|Participant Flow|Adult Cohort|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212705|NCT02280863|FG001|Participant Flow|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212706|NCT02280863|OG000|Outcome|Adult Cohort - Medtronic Android Interface|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212707|NCT02280863|OG001|Outcome|Adult Cohort - Integrated System Interface|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212708|NCT02280863|OG002|Outcome|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212709|NCT02280863|OG000|Outcome|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212710|NCT02280863|OG000|Outcome|Adult Cohort - Integrated System Interface|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11286265|NCT02885506|OG005|Outcome|Cohort 6|"750 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212711|NCT02280863|OG001|Outcome|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212712|NCT02280863|EG000|Reported Event|Adult Cohort|"In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212713|NCT02280863|EG001|Reported Event|Adolescent Cohort|"Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.~Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm."
11212714|NCT02281136|BG000|Baseline|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11212715|NCT02281136|FG000|Participant Flow|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11212716|NCT02281136|OG000|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11212717|NCT02281136|EG000|Reported Event|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11212718|NCT02281318|BG000|Baseline|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212719|NCT02281318|BG001|Baseline|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212720|NCT02281318|BG002|Baseline|Total|Total of all reporting groups
11212721|NCT02281318|FG000|Participant Flow|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212722|NCT02281318|FG001|Participant Flow|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212723|NCT02281318|OG000|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212724|NCT02281318|OG001|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212725|NCT02281318|EG000|Reported Event|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212726|NCT02281318|EG001|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
11212727|NCT02281344|BG000|Baseline|Cohort 1 MMV390048 20mg|"Cohort 1 will receive a single, dose of 20mg MMV390048.~MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.~The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study."
11212728|NCT02281344|FG000|Participant Flow|Cohort 1 MMV390048 20mg|"Cohort 1 will receive a single, dose of 20mg MMV390048.~MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.~The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study."
11212729|NCT02281344|OG000|Outcome|Cohort 1 MMV390048 20mg|"Cohort 1 will receive a single, dose of 20mg MMV390048.~MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.~The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study."
11212730|NCT02281344|EG000|Reported Event|Cohort 1 MMV390048 20mg|"Cohort 1 will receive a single, dose of 20mg MMV390048.~MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use.~The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study."
11212731|NCT02281357|BG000|Baseline|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
11212732|NCT02281357|BG001|Baseline|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
11212733|NCT02281357|BG002|Baseline|Total|Total of all reporting groups
11212734|NCT02281357|FG000|Participant Flow|Tralokinumab|Tralokinumab 300 milligrams (mg) administered by subcutaneous (SC) injection every two weeks (Q2W) over a 40-week treatment period.
11212735|NCT02281357|FG001|Participant Flow|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
11212736|NCT02281357|OG000|Outcome|Tralokinumab|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
11212737|NCT02281357|OG001|Outcome|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
11212738|NCT02281357|EG000|Reported Event|Tralo 300 mg Q2W|Tralokinumab 300 mg administered by SC injection Q2W over a 40-week treatment period.
11212739|NCT02281357|EG001|Reported Event|Placebo|Placebo was administered by SC injection over a 40-week treatment period.
11212740|NCT02281409|BG000|Baseline|Cohort 1 (0.5 mg/kg KW-0761 IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212741|NCT02281409|BG001|Baseline|Cohort 2 (1.0 mg/kg KW-0761IV) Q2W|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212742|NCT02281409|BG002|Baseline|Cohort 3 (3.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212743|NCT02281409|BG003|Baseline|Cohort 4 (10.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212744|NCT02281409|BG004|Baseline|Total|Total of all reporting groups
11212745|NCT02281409|FG000|Participant Flow|Cohort 1 (0.5 mg/kg KW-0761 IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212746|NCT02281409|FG001|Participant Flow|Cohort 2 (1.0 mg/kg KW-0761IV) Q2W|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212747|NCT02281409|FG002|Participant Flow|Cohort 3 (3.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212748|NCT02281409|FG003|Participant Flow|Cohort 4 (10.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212749|NCT02281409|OG000|Outcome|Mogamulizumab (KW-0761)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212750|NCT02281409|OG000|Outcome|Cohort 1 (0.5 mg/kg KW-0761 IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212751|NCT02281409|OG001|Outcome|Cohort 2 (1.0 mg/kg KW-0761IV) Q2W|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212752|NCT02281409|OG002|Outcome|Cohort 3 (3.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212753|NCT02281409|OG003|Outcome|Cohort 4 (10.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212754|NCT02281409|EG000|Reported Event|Cohort 1 (0.5 mg/kg KW-0761 IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212755|NCT02281409|EG001|Reported Event|Cohort 2 (1.0 mg/kg KW-0761IV) Q2W|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212756|NCT02281409|EG002|Reported Event|Cohort 3 (3.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212757|NCT02281409|EG003|Reported Event|Cohort 4 (10.0mg/kg KW-0761IV)|"Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).~Mogamulizumab (KW-0761)"
11212758|NCT02281422|BG000|Baseline|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
11212759|NCT02281422|BG001|Baseline|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
11212760|NCT02281422|BG002|Baseline|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
11212761|NCT02281422|BG003|Baseline|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
11212762|NCT02281422|BG004|Baseline|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
11212763|NCT02281422|BG005|Baseline|Total|Total of all reporting groups
10820074|NCT00053703|BG003|Baseline|Total|Total of all reporting groups
11212764|NCT02281422|FG000|Participant Flow|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
11212765|NCT02281422|FG001|Participant Flow|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
11212766|NCT02281422|FG002|Participant Flow|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
11212767|NCT02281422|FG003|Participant Flow|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
11212768|NCT02281422|FG004|Participant Flow|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
11212769|NCT02281422|OG000|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
11212770|NCT02281422|OG001|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
11212771|NCT02281422|OG002|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
11212772|NCT02281422|OG003|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
11212773|NCT02281422|OG004|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
11212774|NCT02281422|EG000|Reported Event|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
11212775|NCT02281422|EG001|Reported Event|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
11212776|NCT02281422|EG002|Reported Event|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
11212777|NCT02281422|EG003|Reported Event|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
11212778|NCT02281422|EG004|Reported Event|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
11212779|NCT02281448|BG000|Baseline|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
11212780|NCT02281448|BG001|Baseline|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
11212781|NCT02281448|BG002|Baseline|Total|Total of all reporting groups
11212782|NCT02281448|FG000|Participant Flow|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
11212783|NCT02281448|FG001|Participant Flow|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
11212784|NCT02281448|OG000|Outcome|Cmax (BIA 2-194)|Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
11212785|NCT02281448|OG000|Outcome|Overall Population|Overall population - 17 subjects
11212786|NCT02281448|EG000|Reported Event|Eslicarbazepine Acetate 1200 mg + Microginon®|Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
11212787|NCT02281448|EG001|Reported Event|Microginon®|Microginon® (n=18)
11212788|NCT02281526|BG000|Baseline|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212789|NCT02281526|BG001|Baseline|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212790|NCT02281526|BG002|Baseline|Total|Total of all reporting groups
11212791|NCT02281526|FG000|Participant Flow|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212792|NCT02281526|FG001|Participant Flow|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212793|NCT02281526|OG000|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212794|NCT02281526|OG001|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212795|NCT02281526|EG000|Reported Event|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212796|NCT02281526|EG001|Reported Event|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
11212797|NCT02281552|BG000|Baseline|Tofacitinib Modified Release (MR)|Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
10820075|NCT00053703|FG000|Participant Flow|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
10820076|NCT00053703|FG001|Participant Flow|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
11212798|NCT02281552|BG001|Baseline|Tofacitinib Immediate Release (IR)|Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
11212799|NCT02281552|BG002|Baseline|Total|Total of all reporting groups
11212800|NCT02281552|FG000|Participant Flow|Tofacitinib Modified Release (MR)|Participants orally received 11 milligrams (mg) of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
11212801|NCT02281552|FG001|Participant Flow|Tofacitinib Immediate Release (IR)|Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
10820077|NCT00053703|FG002|Participant Flow|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
11212802|NCT02281552|OG000|Outcome|Tofacitinib Modified Release (MR)|Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
11212803|NCT02281552|OG001|Outcome|Tofacitinib Immediate Release (IR)|Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
11212804|NCT02281552|EG000|Reported Event|Tofacitinib Modified Release (MR)|Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks.
11212805|NCT02281552|EG001|Reported Event|Tofacitinib Immediate Release (IR)|Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks.
11212806|NCT02281591|BG000|Baseline|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
11212807|NCT02281591|BG001|Baseline|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
11212808|NCT02281591|BG002|Baseline|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
11212809|NCT02281591|BG003|Baseline|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
11212810|NCT02281591|BG004|Baseline|Total|Total of all reporting groups
11212811|NCT02281591|FG000|Participant Flow|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
11212812|NCT02281591|FG001|Participant Flow|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
11212813|NCT02281591|FG002|Participant Flow|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
11212814|NCT02281591|FG003|Participant Flow|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
11212815|NCT02281591|OG000|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
11212816|NCT02281591|OG001|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
11212817|NCT02281591|OG002|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
11212818|NCT02281591|OG003|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
11212819|NCT02281591|EG000|Reported Event|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
11212820|NCT02281591|EG001|Reported Event|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
11212821|NCT02281591|EG002|Reported Event|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
11212822|NCT02281591|EG003|Reported Event|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
11212823|NCT02281760|BG000|Baseline|Combination Therapy With Dabrafenib and Trametinib in Patients With ECD|Patients with Erdheim Chester Disease (ECD) and BRAFV600E mutation received combination therapy with dabrafenib, a BRAFV600E inhibitor 150mg orally every twelve hours, and trametinib, an inhibitor of MEK, downstream of BRAF, 2mg orally daily.
11212824|NCT02281760|FG000|Participant Flow|Combination Therapy With Dabrafenib and Trametinib in Patients With ECD|Patients with Erdheim Chester Disease (ECD) and BRAFV600E mutation received combination therapy with dabrafenib, a BRAFV600E inhibitor 150mg orally every twelve hours, and trametinib, an inhibitor of MEK, downstream of BRAF, 2mg orally daily.
11212825|NCT02281760|OG000|Outcome|Combination Therapy With Dabrafenib and Trametinib in Patients With ECD|Patients with Erdheim Chester Disease (ECD) and BRAFV600E mutation received combination therapy with dabrafenib, a BRAFV600E inhibitor 150mg orally every twelve hours, and trametinib, an inhibitor of MEK, downstream of BRAF, 2mg orally daily.
10820078|NCT00053703|OG000|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
10820079|NCT00053703|OG001|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
11212826|NCT02281760|EG000|Reported Event|Combination Therapy With Dabrafenib and Trametinib in Patients With ECD|Patients with Erdheim Chester Disease (ECD) and BRAFV600E mutation received combination therapy with dabrafenib, a BRAFV600E inhibitor 150mg orally every twelve hours, and trametinib, an inhibitor of MEK, downstream of BRAF, 2mg orally daily.
11212827|NCT02281773|BG000|Baseline|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
11212828|NCT02281773|BG001|Baseline|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212829|NCT02281773|BG002|Baseline|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212830|NCT02281773|BG003|Baseline|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
11212831|NCT02281773|BG004|Baseline|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
11212832|NCT02281773|BG005|Baseline|Total|Total of all reporting groups
11212833|NCT02281773|FG000|Participant Flow|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
11212834|NCT02281773|FG001|Participant Flow|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212835|NCT02281773|FG002|Participant Flow|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212836|NCT02281773|FG003|Participant Flow|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
11212837|NCT02281773|FG004|Participant Flow|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
11212838|NCT02281773|OG000|Outcome|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
11212839|NCT02281773|OG001|Outcome|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212840|NCT02281773|OG002|Outcome|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212841|NCT02281773|OG003|Outcome|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
11212842|NCT02281773|OG004|Outcome|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
11212843|NCT02281773|EG000|Reported Event|BI 409306 - 10 Milligram|Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
11212844|NCT02281773|EG001|Reported Event|BI 409306 - 25 Milligram|Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212845|NCT02281773|EG002|Reported Event|BI 409306 - 50 Milligram|Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
11212846|NCT02281773|EG003|Reported Event|BI 409306 - 100 Milligram|Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
11212847|NCT02281773|EG004|Reported Event|Placebo|Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
11212848|NCT02281851|BG000|Baseline|Supplemented|The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months
11212849|NCT02281851|BG001|Baseline|Non-Supplemented|The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
11212850|NCT02281851|BG002|Baseline|Total|Total of all reporting groups
11212851|NCT02281851|FG000|Participant Flow|Supplemented|The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months
11212852|NCT02281851|FG001|Participant Flow|Non-supplemented|The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
11212853|NCT02281851|OG000|Outcome|Supplemented|The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months
11212854|NCT02281851|OG001|Outcome|Non-Supplemented|The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
11212855|NCT02281851|EG000|Reported Event|Supplemented|The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months
11212856|NCT02281851|EG001|Reported Event|Non-Supplemented|The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
11212857|NCT02282111|BG000|Baseline|EUS-CNB|"Endoscopic ultrasound-core needle biopsy technique~22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle will be used to take a biopsy from the subepithelial lesion"
11212858|NCT02282111|BG001|Baseline|EUS-SINK|"Endoscopic ultrasound- single incision needle knife technique~conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome will be used to take a biopsy of the subepithelial lesion"
11212859|NCT02282111|BG002|Baseline|Total|Total of all reporting groups
11212860|NCT02282111|FG000|Participant Flow|EUS-CNB|"Endoscopic ultrasound-core needle biopsy technique~22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle was used to take a biopsy from the subepithelial lesion"
11212861|NCT02282111|FG001|Participant Flow|EUS-SINK|"Endoscopic ultrasound- single incision needle knife technique~Conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome was used to take a biopsy of the subepithelial lesion"
11212862|NCT02282111|OG000|Outcome|EUS-CNB|Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.
11212863|NCT02282111|OG001|Outcome|SINK|Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
11212864|NCT02282111|EG000|Reported Event|EUS-CNB|Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated.
11212865|NCT02282111|EG001|Reported Event|SINK|Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
11212866|NCT02282163|BG000|Baseline|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.
11212867|NCT02282163|FG000|Participant Flow|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.
11212868|NCT02282163|OG000|Outcome|Off-site Reader 1 UEUS|Off-site Reader 1 UEUS Assessment
11212869|NCT02282163|OG001|Outcome|Off-site Reader 1 CEUS|Off-site Reader 1 CEUS Assessment
11212870|NCT02282163|OG002|Outcome|Off-site Reader 2 UEUS|Off-site Reader 2 UEUS Assessment
11212871|NCT02282163|OG003|Outcome|Off-site Reader 2 CEUS|Off-site Reader 2 CEUS Assessment
11212872|NCT02282163|OG004|Outcome|Off-site Reader 3 UEUS|Off-site Reader 3 UEUS Assessment
11212873|NCT02282163|OG005|Outcome|Off-site Reader 3 CEUS|Off-site Reader 3 CEUS Assessment
11212874|NCT02282163|OG000|Outcome|Off-site Reader 1 CEUS|Off-site Reader 1 CEUS
11212875|NCT02282163|OG001|Outcome|Off-site Reader 2 CEUS|Off-site Reader 2 CEUS
11212876|NCT02282163|OG002|Outcome|Off-site Reader 3 CEUS|Off-site Reader 3 CEUS
11212877|NCT02282163|OG000|Outcome|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography
11212878|NCT02282163|EG000|Reported Event|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.
11215512|NCT02299791|FG000|Participant Flow|Early Intervention Number of Patients|"Patients in 6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
10820080|NCT00053703|OG002|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
10820081|NCT00053703|EG000|Reported Event|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
11215513|NCT02299791|FG001|Participant Flow|Late Interventions Number of Patients|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
11215514|NCT02299791|OG000|Outcome|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
11215515|NCT02299791|OG001|Outcome|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
11215516|NCT02299791|EG000|Reported Event|Early Intervention|"6 study clinics received the ALL intervention starting 6/1/11~ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.~EHR tools to expedite identification~a. EHR automated point-of-care alerts (Best Practice Alerts)~EHR tools to expedite prescribing~EHR order sets~EHR text shortcuts for notation~patient education materials (handout, poster)~EHR-based outreach support tools a. EHR registries"
11215517|NCT02299791|EG001|Reported Event|Late Implementation|"5 study clinics received the ALL intervention starting 6/1/12~ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial."
11215518|NCT02299869|BG000|Baseline|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215519|NCT02299869|BG001|Baseline|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215520|NCT02299869|BG002|Baseline|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215521|NCT02299869|BG003|Baseline|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215522|NCT02299869|BG004|Baseline|Total|Total of all reporting groups
11215523|NCT02299869|FG000|Participant Flow|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215524|NCT02299869|FG001|Participant Flow|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215525|NCT02299869|FG002|Participant Flow|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215526|NCT02299869|FG003|Participant Flow|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215527|NCT02299869|OG000|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215528|NCT02299869|OG001|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215529|NCT02299869|OG002|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215530|NCT02299869|OG003|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
11215531|NCT02299869|EG000|Reported Event|Overall Participants|Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).
11215532|NCT02300025|BG000|Baseline|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11286266|NCT02885506|OG006|Outcome|Cohort 7|"1000 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11212879|NCT02282293|BG000|Baseline|TS + DP Placebo Pregnancy|"Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Placebo"
11212880|NCT02282293|BG001|Baseline|Daily TS + Monthly DP Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11212881|NCT02282293|BG002|Baseline|Total|Total of all reporting groups
11212882|NCT02282293|FG000|Participant Flow|TS + DP Placebo Pregnancy|"Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Placebo"
11212883|NCT02282293|FG001|Participant Flow|Daily TS + Monthly DP Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11212884|NCT02282293|OG000|Outcome|TS + DP Placebo Pregnancy|"Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Placebo"
11212885|NCT02282293|OG001|Outcome|Daily TS + Monthly DP Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11212886|NCT02282293|EG000|Reported Event|TS + DP Placebo Pregnancy|"Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Placebo"
11212887|NCT02282293|EG001|Reported Event|Daily TS + Monthly DP Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.~Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.~Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy~Monthly dihydroartemisinin-piperaquine (DP) for infants"
11212888|NCT02282514|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Conditioning regimen will be 200 mg/kg of IV cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5, 1.0 mg/kg on days -4 and -3, and then 1.5 mg/kg on days -2 and -1. Methylprednisolone 1000 mg will be infused IV before each dose of rATG. Autologous hematopoietic stem cells (HSCT) will be infused IV on day 0. A granulocyte-colony stimulating factor (G-CSF) 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment. Intravenous Rituxan (500mg) will be administered on days -6 and +1.~HSCT: cells will be collected from blood during mobilization. Then the patient will be given high dose chemotherapy in accordance with approved recommendations for use in conditioning regimens for stem cell transplant in autoimmune diseases. Autologous HSCT is to re-infuse immature cells that can re-establish blood production and patient's immune system.~Cyclophosphamide: Alkylating agent which causes prevention of cell division by forming adducts with DNA Mesna: Medication used to decrease the risk of hemorrhagic cystitis rATG: lymphocyte-specific immunosuppressive agent Methylprednisolone: Steroid G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream Rituxan: Chimeric monoclonal antibody"
11212889|NCT02282514|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Conditioning regimen will be 200 mg/kg of IV cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5, 1.0 mg/kg on days -4 and -3, and then 1.5 mg/kg on days -2 and -1. Methylprednisolone 1000 mg will be infused IV before each dose of rATG. Autologous hematopoietic stem cells (HSCT) will be infused IV on day 0. A granulocyte-colony stimulating factor (G-CSF) 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment. Intravenous Rituxan (500mg) will be administered on days -6 and +1.~HSCT: cells will be collected from blood during mobilization. Then the patient will be given high dose chemotherapy in accordance with approved recommendations for use in conditioning regimens for stem cell transplant in autoimmune diseases. Autologous HSCT is to re-infuse immature cells that can re-establish blood production and patient's immune system.~Cyclophosphamide: Alkylating agent which causes prevention of cell division by forming adducts with DNA Mesna: Medication used to decrease the risk of hemorrhagic cystitis rATG: lymphocyte-specific immunosuppressive agent Methylprednisolone: Steroid G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream Rituxan: Chimeric monoclonal antibody"
11212890|NCT02282514|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Conditioning regimen will be 200 mg/kg of IV cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5, 1.0 mg/kg on days -4 and -3, and then 1.5 mg/kg on days -2 and -1. Methylprednisolone 1000 mg will be infused IV before each dose of rATG. Autologous hematopoietic stem cells (HSCT) will be infused IV on day 0. A granulocyte-colony stimulating factor (G-CSF) 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment. Intravenous Rituxan (500mg) will be administered on days -6 and +1.~HSCT: cells will be collected from blood during mobilization. Then the patient will be given high dose chemotherapy in accordance with approved recommendations for use in conditioning regimens for stem cell transplant in autoimmune diseases. Autologous HSCT is to re-infuse immature cells that can re-establish blood production and patient's immune system.~Cyclophosphamide: Alkylating agent which causes prevention of cell division by forming adducts with DNA Mesna: Medication used to decrease the risk of hemorrhagic cystitis rATG: lymphocyte-specific immunosuppressive agent Methylprednisolone: Steroid G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream Rituxan: Chimeric monoclonal antibody"
11212891|NCT02282514|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Conditioning regimen will be 200 mg/kg of IV cyclophosphamide given in 4 equal fractions on days -5 through -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5, 1.0 mg/kg on days -4 and -3, and then 1.5 mg/kg on days -2 and -1. Methylprednisolone 1000 mg will be infused IV before each dose of rATG. Autologous hematopoietic stem cells (HSCT) will be infused IV on day 0. A granulocyte-colony stimulating factor (G-CSF) 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment. Intravenous Rituxan (500mg) will be administered on days -6 and +1.~HSCT: cells will be collected from blood during mobilization. Then the patient will be given high dose chemotherapy in accordance with approved recommendations for use in conditioning regimens for stem cell transplant in autoimmune diseases. Autologous HSCT is to re-infuse immature cells that can re-establish blood production and patient's immune system.~Cyclophosphamide: Alkylating agent which causes prevention of cell division by forming adducts with DNA Mesna: Medication used to decrease the risk of hemorrhagic cystitis rATG: lymphocyte-specific immunosuppressive agent Methylprednisolone: Steroid G-CSF: Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream Rituxan: Chimeric monoclonal antibody"
11212892|NCT02282527|BG000|Baseline|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
11212893|NCT02282527|BG001|Baseline|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
11212894|NCT02282527|BG002|Baseline|Total|Total of all reporting groups
11212895|NCT02282527|FG000|Participant Flow|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
11212896|NCT02282527|FG001|Participant Flow|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
11212897|NCT02282527|OG000|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions"
11212898|NCT02282527|OG001|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
11212899|NCT02282527|OG000|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
11212900|NCT02282527|OG000|Outcome|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
11212901|NCT02282527|OG001|Outcome|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
11212902|NCT02282527|EG000|Reported Event|Liquid Alpha₁-PI|Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
11212903|NCT02282527|EG001|Reported Event|Prolastin-C|Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
10820082|NCT00053703|EG001|Reported Event|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
11212904|NCT02282605|BG000|Baseline|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212905|NCT02282605|BG001|Baseline|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212906|NCT02282605|BG002|Baseline|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212907|NCT02282605|BG003|Baseline|Total|Total of all reporting groups
11215533|NCT02300025|BG001|Baseline|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11212908|NCT02282605|FG000|Participant Flow|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212909|NCT02282605|FG001|Participant Flow|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212910|NCT02282605|FG002|Participant Flow|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212911|NCT02282605|OG000|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212912|NCT02282605|OG001|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212913|NCT02282605|OG002|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212914|NCT02282605|EG000|Reported Event|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212915|NCT02282605|EG001|Reported Event|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212916|NCT02282605|EG002|Reported Event|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
11212917|NCT02282631|BG000|Baseline|Control School|School with no intervention; ongoing advice on active school travel.
11212918|NCT02282631|BG001|Baseline|Intervention School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw. Every trip to school reported by the parent as being active (walking/cycling) corresponds to one ticket entered into the draw. In total, one child can have up to five tickets entered into one draw."
11212919|NCT02282631|BG002|Baseline|Total|Total of all reporting groups
11212920|NCT02282631|FG000|Participant Flow|Control Group School|School with no intervention (incentive scheme)
11212921|NCT02282631|FG001|Participant Flow|Intervention Group School|School with intervention (incentive scheme)
11212922|NCT02282631|OG000|Outcome|Schools Contacted|Primary schools (or equivalent) located in the North East approached in this study
11212923|NCT02282631|OG000|Outcome|Schools Who Took Part|Schools who took part in this study (two)
11212924|NCT02282631|OG000|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
11212925|NCT02282631|OG001|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
11212926|NCT02282631|OG000|Outcome|ATS Trips|active trips to school
11212927|NCT02282631|OG001|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
11212928|NCT02282631|OG000|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
11212929|NCT02282631|OG001|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
11212930|NCT02282631|EG000|Reported Event|Control Group School|School with no intervention (incentive scheme)
11212931|NCT02282631|EG001|Reported Event|Intervention Group School|School with intervention (incentive scheme)
11212932|NCT02282722|BG000|Baseline|Usual Informed Consent|"Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.~Usual, standard-of-care informed consent for chemotherapy: The enrolling site's institutional standard-of-care informed consent materials."
11212933|NCT02282722|BG001|Baseline|Investigational Informed Consent|"Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.~Investigational informed consent for chemotherapy: Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet."
11212934|NCT02282722|BG002|Baseline|Total|Total of all reporting groups
11212935|NCT02282722|FG000|Participant Flow|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
11212936|NCT02282722|FG001|Participant Flow|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
11212937|NCT02282722|OG000|Outcome|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
11212938|NCT02282722|OG001|Outcome|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
11212939|NCT02282722|EG000|Reported Event|Patient Usual Care Arm|Patients randomized to usual care informed consent materials.
11212940|NCT02282722|EG001|Reported Event|Patient Investigational Care Arm|Patients randomized to the investigational informed consent materials.
11212941|NCT02282813|BG000|Baseline|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
11212942|NCT02282813|BG001|Baseline|CTAP101 Capsules (Monotherapy; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
11212943|NCT02282813|BG002|Baseline|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
11212944|NCT02282813|BG003|Baseline|Total|Total of all reporting groups
11212945|NCT02282813|FG000|Participant Flow|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
11212946|NCT02282813|FG001|Participant Flow|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
11212947|NCT02282813|FG002|Participant Flow|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
11212948|NCT02282813|OG000|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
11212949|NCT02282813|OG001|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
11212950|NCT02282813|OG002|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
11212951|NCT02282813|OG000|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
11212952|NCT02282813|OG001|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
11212953|NCT02282813|EG000|Reported Event|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
11212954|NCT02282813|EG001|Reported Event|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
11212955|NCT02282813|EG002|Reported Event|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
11212956|NCT02282904|BG000|Baseline|CGD Recipient|"CGD patients that will undergo haplo transplantation with post-transplant cyclophosphamide as described~Sirolimus: For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD).~Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum).~Donor peripheral blood stem cells.: Infuse donor graft.~Cyclophosphamide post transplant: 50 mg/kg/d IV infused over 90 minutes. Day +3 and +4~Total body 200cGy: Day -1~Cyclophosphamide: 14.5 mg/kg IV over one hour Day -6 and -5~Fludarabine: 30 mg/m2 over 30 minutes Day -6 through Day -2~Busulfan: Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2"
11212957|NCT02282904|FG000|Participant Flow|CGD Recipient|"CGD patients that will undergo haplo transplantation with post-transplant cyclophosphamide as described~Sirolimus: For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD).~Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum).~Donor peripheral blood stem cells.: Infuse donor graft.~Cyclophosphamide post transplant: 50 mg/kg/d IV infused over 90 minutes. Day +3 and +4~Total body 200cGy: Day -1~Cyclophosphamide: 14.5 mg/kg IV over one hour Day -6 and -5~Fludarabine: 30 mg/m2 over 30 minutes Day -6 through Day -2~Busulfan: Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2"
11212958|NCT02282904|OG000|Outcome|CGD Recipient|"CGD patients that will undergo haplo transplantation with post-transplant cyclophosphamide as described~Sirolimus: For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD).~Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum).~Donor peripheral blood stem cells.: Infuse donor graft.~Cyclophosphamide post transplant: 50 mg/kg/d IV infused over 90 minutes. Day +3 and +4~Total body 200cGy: Day -1~Cyclophosphamide: 14.5 mg/kg IV over one hour Day -6 and -5~Fludarabine: 30 mg/m2 over 30 minutes Day -6 through Day -2~Busulfan: Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2"
11212959|NCT02282904|EG000|Reported Event|CGD Recipient|"CGD patients that will undergo haplo transplantation with post-transplant cyclophosphamide as described~Sirolimus: For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD).~Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum).~Donor peripheral blood stem cells.: Infuse donor graft.~Cyclophosphamide post transplant: 50 mg/kg/d IV infused over 90 minutes. Day +3 and +4~Total body 200cGy: Day -1~Cyclophosphamide: 14.5 mg/kg IV over one hour Day -6 and -5~Fludarabine: 30 mg/m2 over 30 minutes Day -6 through Day -2~Busulfan: Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2"
11212960|NCT02282930|BG000|Baseline|ACTH Gel|"Injected does of 80 units subcutaneously twice weekly for 6 months.~ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months."
11212961|NCT02282930|FG000|Participant Flow|Acthar (ACTH) Gel|"Injected does of 80 units subcutaneously twice weekly for 6 months.~Acthar (ACTH) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months."
11212962|NCT02282930|OG000|Outcome|Acthar (ACTH) Gel|"Injected does of 80 units subcutaneously twice weekly for 6 months.~ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months."
11212963|NCT02282930|EG000|Reported Event|ACTH Gel|"Injected does of 80 units subcutaneously twice weekly for 6 months.~ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months."
11212964|NCT02282982|BG000|Baseline|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
11212965|NCT02282982|FG000|Participant Flow|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
11212966|NCT02282982|OG000|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
11212967|NCT02282982|EG000|Reported Event|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
11212968|NCT02283268|BG000|Baseline|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
11212969|NCT02283268|FG000|Participant Flow|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
11212970|NCT02283268|OG000|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
11212971|NCT02283268|OG001|Outcome|Minor Surgery|All participants who underwent minor surgery.
11212972|NCT02283268|OG002|Outcome|Major Surgery|All participants who underwent major surgery.
11212973|NCT02283268|OG003|Outcome|Oral Surgery|All participants who underwent oral surgery.
11212974|NCT02283268|OG004|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
11212975|NCT02283268|OG005|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
11212976|NCT02283268|OG006|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
11212977|NCT02283268|OG007|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
11212978|NCT02283268|OG008|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
11212979|NCT02283268|EG000|Reported Event|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
11212980|NCT02283294|BG000|Baseline|Apixaban|"Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively~Apixaban"
11212981|NCT02283294|BG001|Baseline|Warfarin|"standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).~Warfarin"
11212982|NCT02283294|BG002|Baseline|Total|Total of all reporting groups
11212983|NCT02283294|FG000|Participant Flow|Apixaban|"Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively~Apixaban"
11212984|NCT02283294|FG001|Participant Flow|Warfarin|"standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).~Warfarin"
11212985|NCT02283294|OG000|Outcome|Apixaban|"Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively~Apixaban"
11212986|NCT02283294|OG001|Outcome|Warfarin|"Standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).~Warfarin"
11212987|NCT02283294|OG001|Outcome|Warfarin|"standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).~Warfarin"
11212988|NCT02283294|EG000|Reported Event|Apixaban|"Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively~Apixaban"
11212989|NCT02283294|EG001|Reported Event|Warfarin|"standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).~Warfarin"
11212990|NCT02283333|BG000|Baseline|BATE-G|"Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.~BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant."
11212991|NCT02283333|BG001|Baseline|Standard Treatment|"Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.~Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant."
11212992|NCT02283333|BG002|Baseline|Total|Total of all reporting groups
11212993|NCT02283333|FG000|Participant Flow|BATE-G|"Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.~BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant."
11212994|NCT02283333|FG001|Participant Flow|Standard Treatment|"Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.~Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant."
11212995|NCT02283333|OG000|Outcome|BATE-G|"Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.~BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant."
11212996|NCT02283333|OG001|Outcome|Standard Treatment|"Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.~Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant."
11212997|NCT02283333|EG000|Reported Event|BATE-G|"Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.~BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant."
11212998|NCT02283333|EG001|Reported Event|Standard Treatment|"Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.~Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant."
11212999|NCT02283411|BG000|Baseline|Diabetes Mellitus, Type 1 and Type 2|"Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes."
11213000|NCT02283411|FG000|Participant Flow|Diabetes Mellitus, Type 1 and Type 2|"Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes."
11213001|NCT02283411|OG000|Outcome|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes."
11213002|NCT02283411|EG000|Reported Event|Diabetes Mellitus, Type 1 and Type 2|"Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal[P] and Professional [Pro] and received no treatment except for safety purposes.~Reported adverse events were determined to be related to study procedures. Those events were observed in six (6) subjects who wore the two Systems (Personal[P] and Professional [Pro]) as required by protocol."
11213003|NCT02283528|BG000|Baseline|Hybrid|"Placement of Hybrid arch bars for open or closed reduction of mandible fractures~Stryker Hybrid: Place Hybrid arch bars"
11213004|NCT02283528|BG001|Baseline|Erich|"Placement of Erich archbars for open or closed reduction of mandible fractures~Erich: Control group is Erich arch bars"
11213005|NCT02283528|BG002|Baseline|Total|Total of all reporting groups
11213006|NCT02283528|FG000|Participant Flow|Hybrid|"Placement of Hybrid arch bars for open or closed reduction of mandible fractures~Stryker Hybrid: Place Hybrid arch bars"
11213007|NCT02283528|FG001|Participant Flow|Erich|"Placement of Erich archbars for open or closed reduction of mandible fractures~Erich: Control group is Erich arch bars"
11213008|NCT02283528|OG000|Outcome|Hybrid|"Placement of Hybrid arch bars for open or closed reduction of mandible fractures~Stryker Hybrid: Place Hybrid arch bars"
11213009|NCT02283528|OG001|Outcome|Erich|"Placement of Erich archbars for open or closed reduction of mandible fractures~Erich: Control group is Erich arch bars"
11213010|NCT02283528|EG000|Reported Event|Hybrid|"Placement of Hybrid arch bars for open or closed reduction of mandible fractures~Stryker Hybrid: Place Hybrid arch bars"
11213011|NCT02283528|EG001|Reported Event|Erich|"Placement of Erich archbars for open or closed reduction of mandible fractures~Erich: Control group is Erich arch bars"
11213012|NCT02283658|BG000|Baseline|Treatment (Everolimus and Letrozole)|Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11213013|NCT02283658|FG000|Participant Flow|Treatment (Everolimus and Letrozole)|Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10820083|NCT00053703|EG002|Reported Event|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
11213014|NCT02283658|OG000|Outcome|Treatment (Everolimus and Letrozole)|Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11213015|NCT02283658|EG000|Reported Event|Treatment (Everolimus and Letrozole)|Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11213016|NCT02283749|BG000|Baseline|Xofigo|"Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.~Xofigo: This is a radio-isotope"
11213017|NCT02283749|FG000|Participant Flow|Xofigo|"Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.~Xofigo: This is a radio-isotope"
11213018|NCT02283749|OG000|Outcome|Xofigo|"Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.~Xofigo: This is a radio-isotope"
11213019|NCT02283749|EG000|Reported Event|Xofigo|"Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.~Xofigo: This is a radio-isotope"
11213020|NCT02283762|BG000|Baseline|Riociguat (Adempas, BAY63-2521)|Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213021|NCT02283762|BG001|Baseline|Placebo|Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213022|NCT02283762|BG002|Baseline|Total|Total of all reporting groups
11213023|NCT02283762|FG000|Participant Flow|Riociguat (Adempas, BAY63-2521)|Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213024|NCT02283762|FG001|Participant Flow|Placebo|Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213025|NCT02283762|OG000|Outcome|Riociguat (Adempas, BAY63-2521)|Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213026|NCT02283762|OG001|Outcome|Placebo|Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213027|NCT02283762|EG000|Reported Event|Riociguat-Riociguat (LTE Phase)|Main treatment phase: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213028|NCT02283762|EG001|Reported Event|Placebo-Riociguat (LTE Phase)|Main treatment phase: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213029|NCT02283762|EG002|Reported Event|Riociguat (Main Treatment Phase)|Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213030|NCT02283762|EG003|Reported Event|Placebo (Main Treatment Phase)|Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
11213031|NCT02283788|BG000|Baseline|Treatment Sequence ABCD|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
11213032|NCT02283788|BG001|Baseline|Treatment Sequence BDAC|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
11213033|NCT02283788|BG002|Baseline|Treatment Sequence CADB|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
11213034|NCT02283788|BG003|Baseline|Treatment Sequence DCBA|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
11213035|NCT02283788|BG004|Baseline|Total|Total of all reporting groups
11213036|NCT02283788|FG000|Participant Flow|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
11213037|NCT02283788|FG001|Participant Flow|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
11213038|NCT02283788|FG002|Participant Flow|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
11213039|NCT02283788|FG003|Participant Flow|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
11213040|NCT02283788|OG000|Outcome|BIA 2-093 1200 mg|ESL, Eslicarbazepine 1200 mg
11213041|NCT02283788|OG001|Outcome|BIA 2-093 2400 mg|ESL, Eslicarbazepine 1200 mg
11213042|NCT02283788|OG002|Outcome|Moxifloxacin 400 mg|brand names Avelox, Avalox, and Avelon
11213043|NCT02283788|OG003|Outcome|Placebo|Placebo, PLC
11213044|NCT02283788|EG000|Reported Event|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
11213045|NCT02283788|EG001|Reported Event|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
11213046|NCT02283788|EG002|Reported Event|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
11213047|NCT02283788|EG003|Reported Event|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
11213048|NCT02283814|BG000|Baseline|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
11213049|NCT02283814|BG001|Baseline|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
11213050|NCT02283814|BG002|Baseline|Total|Total of all reporting groups
11213051|NCT02283814|FG000|Participant Flow|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
11213052|NCT02283814|FG001|Participant Flow|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
11213053|NCT02283814|OG000|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
11213054|NCT02283814|OG001|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
11213055|NCT02283814|EG000|Reported Event|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
11213056|NCT02283814|EG001|Reported Event|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
11213057|NCT02283827|BG000|Baseline|Group A BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
11213058|NCT02283827|BG001|Baseline|Group B BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
11213059|NCT02283827|BG002|Baseline|Total|Total of all reporting groups
11213060|NCT02283827|FG000|Participant Flow|Group A BIA 2-093 + Phenytoin (PHT)|Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
11213061|NCT02283827|FG001|Participant Flow|Group B BIA 2-093 + Phenytoin (PHT)|"Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg~+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg"
11213062|NCT02283827|OG000|Outcome|BIA 2-093 + Phenytoin|Phenytoin - PHT; BIA 2-093 - ESL, Eslicarbazepine
11213063|NCT02283827|OG001|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
11213064|NCT02283827|OG000|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
11213065|NCT02283827|EG000|Reported Event|BIA 2-093 600 mg|BIA 2-093 - ESL, Eslicarbazepine
11213066|NCT02283827|EG001|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine
11213067|NCT02283827|EG002|Reported Event|BIA 2-093 1200 mg + Phenytoin 100 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
11213068|NCT02283827|EG003|Reported Event|BIA 2-093 1200 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
11213069|NCT02283827|EG004|Reported Event|Phenytoin 100 mg|Phenytoin - PHT 100 mg
11213070|NCT02283827|EG005|Reported Event|Phenytoin 300 mg|Phenytoin - PHT 300 mg
11213071|NCT02283827|EG006|Reported Event|BIA 2-093 600 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
11213072|NCT02283840|BG000|Baseline|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213073|NCT02283840|BG001|Baseline|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213074|NCT02283840|BG002|Baseline|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213075|NCT02283840|BG003|Baseline|Total|Total of all reporting groups
11213076|NCT02283840|FG000|Participant Flow|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213077|NCT02283840|FG001|Participant Flow|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213078|NCT02283840|FG002|Participant Flow|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213079|NCT02283840|OG000|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213080|NCT02283840|OG001|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213081|NCT02283840|OG002|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
11213082|NCT02283840|EG000|Reported Event|Test 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg To-Be-Marketed Formulation, TBM
11213083|NCT02283840|EG001|Reported Event|Test 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg To-Be-Marketed Formulation, TBM
11213084|NCT02283840|EG002|Reported Event|Test 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg To-Be-Marketed Formulation, TBM
11213085|NCT02283840|EG003|Reported Event|Reference 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
11213086|NCT02283840|EG004|Reported Event|Reference 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
11213087|NCT02283840|EG005|Reported Event|Reference 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
11213088|NCT02284009|BG000|Baseline|Placebo|Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.
11213089|NCT02284009|BG001|Baseline|Albiglutide|Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
11213090|NCT02284009|BG002|Baseline|Total|Total of all reporting groups
11213091|NCT02284009|FG000|Participant Flow|Placebo|Matching placebo was administered once weekly for 52 weeks by subcutaneous (sc) injection in the abdomen, thigh or upper arm region in addition to insulin.
11213092|NCT02284009|FG001|Participant Flow|Albiglutide|Albiglutide 30 milligram (mg) was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
11213093|NCT02284009|OG000|Outcome|Placebo|Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.
11213094|NCT02284009|OG001|Outcome|Albiglutide|Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
11213095|NCT02284009|OG002|Outcome|DEFEND-1 Placebo|Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
11213096|NCT02284009|OG000|Outcome|Albiglutide|Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
11213097|NCT02284009|EG000|Reported Event|Placebo|Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.
11213098|NCT02284009|EG001|Reported Event|Albiglutide|Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
11213099|NCT02284126|BG000|Baseline|Topical Vancomycin|"Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis~Vancomycin: Topically applied powder and paste to surgical site at time of closure."
11213100|NCT02284126|BG001|Baseline|Standard of Care|Control group, receive standard of care only
11213101|NCT02284126|BG002|Baseline|Total|Total of all reporting groups
11213102|NCT02284126|FG000|Participant Flow|Topical Vancomycin|"Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis~Vancomycin: Topically applied powder and paste to surgical site at time of closure."
11213103|NCT02284126|FG001|Participant Flow|Standard of Care|Control group, receive standard of care only
11213104|NCT02284126|OG000|Outcome|Topical Vancomycin|"Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis~Vancomycin: Topically applied powder and paste to surgical site at time of closure."
11213105|NCT02284126|OG001|Outcome|Standard of Care|Control group, receive standard of care only
11213106|NCT02284126|EG000|Reported Event|Topical Vancomycin|"Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis~Vancomycin: Topically applied powder and paste to surgical site at time of closure."
11213107|NCT02284126|EG001|Reported Event|Standard of Care|Control group, receive standard of care only
11213108|NCT02284165|BG000|Baseline|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
11213109|NCT02284165|BG001|Baseline|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
11213110|NCT02284165|BG002|Baseline|Discharged Home|Discharged from hospital to home with or without services
11213111|NCT02284165|BG003|Baseline|Total|Total of all reporting groups
11213112|NCT02284165|FG000|Participant Flow|Inpatient Rehab Facility (IRF)|Discharged from hospital to inpatient rehabilitation facility
10820084|NCT00053846|BG000|Baseline|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
11213113|NCT02284165|FG001|Participant Flow|Skilled Nursing Facility (SNF)|Discharged from hospital to skilled nursing facility
11213114|NCT02284165|FG002|Participant Flow|Discharged Home|Discharged from hospital to home with or without services
11213115|NCT02284165|OG000|Outcome|All Patients|Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
11213116|NCT02284165|OG000|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
11213117|NCT02284165|OG001|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
11213118|NCT02284165|EG000|Reported Event|All Patients|Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry.
11213119|NCT02284178|BG000|Baseline|Enhanced Oral Suction|Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
11213120|NCT02284178|BG001|Baseline|Usual Care Oral Suction|Oropharyngeal suction with suction swab; standard oral cleansing every 4 hours.
11213121|NCT02284178|BG002|Baseline|Total|Total of all reporting groups
11213122|NCT02284178|FG000|Participant Flow|Enhanced Oral Suction|Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
11213123|NCT02284178|FG001|Participant Flow|Usual Care Oral Suction|Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
11213124|NCT02284178|OG000|Outcome|Enhanced Oral Suction|Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
11213125|NCT02284178|OG001|Outcome|Usual Care Oral Suction|Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
11213126|NCT02284178|EG000|Reported Event|Enhanced Oral Suction|Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
11213127|NCT02284178|EG001|Reported Event|Usual Care Oral Suction|Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
11213128|NCT02284243|BG000|Baseline|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
11213129|NCT02284243|BG001|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
11213130|NCT02284243|BG002|Baseline|Total|Total of all reporting groups
11213131|NCT02284243|FG000|Participant Flow|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
11213132|NCT02284243|FG001|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
11213133|NCT02284243|OG000|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
11213134|NCT02284243|OG001|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
11213135|NCT02284243|EG000|Reported Event|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
11213136|NCT02284243|EG001|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
11213137|NCT02284347|BG000|Baseline|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
11213138|NCT02284347|FG000|Participant Flow|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
11213139|NCT02284347|OG000|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
11213140|NCT02284347|EG000|Reported Event|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
11213141|NCT02284386|BG000|Baseline|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
11213142|NCT02284386|FG000|Participant Flow|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
11213143|NCT02284386|OG000|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
11213144|NCT02284386|EG000|Reported Event|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
11213145|NCT02284399|BG000|Baseline|IDTFK Group Post NIPT - (January 2012-June 2014)|Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
11213146|NCT02284399|BG001|Baseline|IDTFK Group Pre-NIPT (January 2010-July 2010)|A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
11213147|NCT02284399|BG002|Baseline|Total|Total of all reporting groups
11213148|NCT02284399|FG000|Participant Flow|IDTFK Group Pre-NIPT (January 2010-July 2010)|"A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation.~Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or chorionic villus sampling (CVS)"
11213149|NCT02284399|FG001|Participant Flow|IDTFK Group Post NIPT - (January 2012-June 2014)|"Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation.~Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or CVS"
10820085|NCT00053846|BG001|Baseline|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
10820086|NCT00053846|BG002|Baseline|Total|Total of all reporting groups
11213150|NCT02284399|OG000|Outcome|IDTFK Group Pre-NIPT (January 2010-July 2010)|A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
11213151|NCT02284399|OG001|Outcome|IDTFK Group Post NIPT - (January 2012-June 2014)|"Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation"
11213152|NCT02284399|OG000|Outcome|IDTFK Group Post NIPT - (January 2012-June 2014)|"Number of pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing procedure: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation"
11213153|NCT02284399|OG001|Outcome|IDTFK Group Pre-NIPT (January 2010-July 2010)|A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
11213154|NCT02284399|EG000|Reported Event|IDTFK Group Pre-NIPT (January 2010-July 2010)|"A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation.~Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or CVS"
11213155|NCT02284399|EG001|Reported Event|IDTFK Group Post NIPT - (January 2012-June 2014)|"Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).~non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation.~Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or CVS"
11213156|NCT02284464|BG000|Baseline|Steroids, Tacrolimus and Mycophenolate|"Normal treatment arm~Prednisone continuation: Continuation of steroids"
11213157|NCT02284464|BG001|Baseline|Tacrolimus and Mycophenolate|"Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs~Prednisone withdrawal: Withdrawal of steroids"
11213158|NCT02284464|BG002|Baseline|Total|Total of all reporting groups
11213159|NCT02284464|FG000|Participant Flow|Steroids, Tacrolimus and Mycophenolate|"Normal treatment arm~Prednisone continuation: Continuation of steroids"
11213160|NCT02284464|FG001|Participant Flow|Tacrolimus and Mycophenolate|"Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs~Prednisone withdrawal: Withdrawal of steroids"
11213161|NCT02284464|OG000|Outcome|Steroids, Tacrolimus and Mycophenolate|"Normal treatment arm~Prednisone continuation: Continuation of steroids"
11213162|NCT02284464|OG001|Outcome|Tacrolimus and Mycophenolate|"Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs~Prednisone withdrawal: Withdrawal of steroids"
11213163|NCT02284464|EG000|Reported Event|Steroids, Tacrolimus and Mycophenolate|"Normal treatment arm~Prednisone continuation: Continuation of steroids"
11213164|NCT02284464|EG001|Reported Event|Tacrolimus and Mycophenolate|"Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs~Prednisone withdrawal: Withdrawal of steroids"
11213165|NCT02284516|BG000|Baseline|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213166|NCT02284516|BG001|Baseline|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213167|NCT02284516|BG002|Baseline|Total|Total of all reporting groups
11213168|NCT02284516|FG000|Participant Flow|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213169|NCT02284516|FG001|Participant Flow|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213170|NCT02284516|OG000|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213171|NCT02284516|OG001|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213172|NCT02284516|EG000|Reported Event|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213173|NCT02284516|EG001|Reported Event|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
11213174|NCT02284555|BG000|Baseline|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
11213175|NCT02284555|FG000|Participant Flow|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
11213176|NCT02284555|OG000|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
11213177|NCT02284555|EG000|Reported Event|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
11213178|NCT02284828|BG000|Baseline|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
11213179|NCT02284828|FG000|Participant Flow|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
11213180|NCT02284828|OG000|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
11213181|NCT02284828|EG000|Reported Event|BIA 2-093 900 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
11213182|NCT02284828|EG001|Reported Event|Placebo|Placebo, PLC
11213183|NCT02284828|EG002|Reported Event|BIA 2-093 800 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
11213184|NCT02284828|EG003|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
11213185|NCT02284854|BG000|Baseline|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
11213186|NCT02284854|BG001|Baseline|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
11213187|NCT02284854|BG002|Baseline|Total|Total of all reporting groups
11213188|NCT02284854|FG000|Participant Flow|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
11213189|NCT02284854|FG001|Participant Flow|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
11213190|NCT02284854|OG000|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
11213191|NCT02284854|OG000|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
11213192|NCT02284854|EG000|Reported Event|CBZ 200 mg|Group B CBZ 200 mg
11213193|NCT02284854|EG001|Reported Event|CBZ 400 mg|Group B CBZ 400 mg
11213194|NCT02284854|EG002|Reported Event|CBZ 400 mg Twice-daily|Group B CBZ 400 mg twice-daily
11213195|NCT02284854|EG003|Reported Event|ESL 800 mg + CBZ 400 mg Twice-daily|Group A + B ESL 800 mg + CBZ 400 mg twice-daily
11213196|NCT02284854|EG004|Reported Event|ESL 800 mg|Group A ESL 800 mg
11213197|NCT02284854|EG005|Reported Event|ESL 800 mg + CBZ 200 mg|Group A ESL 800 mg + CBZ 200 mg
11213198|NCT02284854|EG006|Reported Event|ESL 800 mg + CBZ 400 mg|Group A ESL 800 mg + CBZ 400 mg
11213199|NCT02284854|EG007|Reported Event|Before Treatment|Group A and B Before treatment
11213200|NCT02284854|EG008|Reported Event|After Treatment|Group A and B After treatment
11213201|NCT02284867|BG000|Baseline|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213202|NCT02284867|BG001|Baseline|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213203|NCT02284867|BG002|Baseline|Total|Total of all reporting groups
10820087|NCT00053846|FG000|Participant Flow|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
11244582|NCT02512302|FG008|Participant Flow|Treatment Group Nine|Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63 mcg; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer SUN-101 50 mcg via eFlow nebulizer with activated charcoalfor each of the five treatment periods
11244583|NCT02512302|FG009|Participant Flow|Treatment Group Ten|Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion;Seebri Breezhaler 63mcg for each of the five treatment periods
11244584|NCT02512302|OG000|Outcome|SUN-101 Via eFlow Nebulizer|"50 mcg glycopyrrolate via Electronic Nebulizer~SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer"
11244585|NCT02512302|OG001|Outcome|SUN-101 Via eFlow Nebulizer With Activated Charcoal|"50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal~SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal"
11244586|NCT02512302|OG002|Outcome|Seebri® Breezhaler®|"63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI~Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI"
11244587|NCT02512302|OG003|Outcome|Seebri® Breezhaler® With Activated Charcoal|": : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal~Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal"
11244588|NCT02512302|OG004|Outcome|: Glycopyrrolate Injection|"50 mcg glycopyrrolate via IV infusion~Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV"
11244589|NCT02512302|OG000|Outcome|: Glycopyrrolate Injection|"50 mcg glycopyrrolate via IV infusion~Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV"
11244590|NCT02512302|EG000|Reported Event|SUN-101 Via eFlow Nebulizer|"50 mcg glycopyrrolate via Electronic Nebulizer~SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer"
11244591|NCT02512302|EG001|Reported Event|SUN-101 Via eFlow Nebulizer With Activated Charcoal|"50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal~SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal"
11244592|NCT02512302|EG002|Reported Event|Seebri® Breezhaler®|"63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI~Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI"
11244593|NCT02512302|EG003|Reported Event|Seebri® Breezhaler® With Activated Charcoal|": : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal~Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal"
11244594|NCT02512302|EG004|Reported Event|: Glycopyrrolate Injection|"50 mcg glycopyrrolate via IV infusion~Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV"
11244595|NCT02512393|BG000|Baseline|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244596|NCT02512393|BG001|Baseline|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244597|NCT02512393|BG002|Baseline|Total|Total of all reporting groups
11244598|NCT02512393|FG000|Participant Flow|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244599|NCT02512393|FG001|Participant Flow|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244600|NCT02512393|OG000|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244601|NCT02512393|OG001|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244602|NCT02512393|EG000|Reported Event|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
11244603|NCT02512393|EG001|Reported Event|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10820088|NCT00053846|FG001|Participant Flow|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
11244604|NCT02512419|BG000|Baseline|Text-Enhanced Physical Activity Intervention Arm|"The Spanish-language Physical Activity intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).~Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.~Actigraph GT3X"
11244605|NCT02512419|BG001|Baseline|Health Education Control Arm|"The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.~Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.~Actigraph GT3X"
11244606|NCT02512419|BG002|Baseline|Total|Total of all reporting groups
11244607|NCT02512419|FG000|Participant Flow|Text-Enhanced Physical Activity Intervention Arm|"The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).~Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.~Actigraph GT3X"
11244608|NCT02512419|FG001|Participant Flow|Health Education Control Arm|"The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.~Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.~Actigraph GT3X"
11244609|NCT02512419|OG000|Outcome|Text-Enhanced Physical Activity Intervention Arm|"The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).~Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.~Actigraph GT3X"
11244610|NCT02512419|OG001|Outcome|Health Education Control Arm|"The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.~Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.~Actigraph GT3X"
11244611|NCT02512419|EG000|Reported Event|Text-Enhanced Physical Activity Intervention Arm|"The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).~Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.~Actigraph GT3X"
11244612|NCT02512419|EG001|Reported Event|Health Education Control Arm|"The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.~Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.~Actigraph GT3X"
11244613|NCT02512575|BG000|Baseline|AZD9567 - 2 mg|In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
11244614|NCT02512575|BG001|Baseline|AZD9567 - 10 mg|In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
11244615|NCT02512575|BG002|Baseline|AZD9567 - 20 mg|In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
11244616|NCT02512575|BG003|Baseline|AZD9567 - 40 mg|In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
11244617|NCT02512575|BG004|Baseline|AZD9567 - 80 mg|In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
11244618|NCT02512575|BG005|Baseline|AZD9567 - 100 mg|In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
11244619|NCT02512575|BG006|Baseline|AZD9567 - 125 mg|In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
11244620|NCT02512575|BG007|Baseline|AZD9567 - 155 mg|In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
11244621|NCT02512575|BG008|Baseline|Prednisolone - 60 mg|In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
11244622|NCT02512575|BG009|Baseline|Pooled Placebo|In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
11244623|NCT02512575|BG010|Baseline|Total|Total of all reporting groups
11244624|NCT02512575|FG000|Participant Flow|AZD9567 - 2 mg|In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
11244625|NCT02512575|FG001|Participant Flow|AZD9567 - 10 mg|In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
11244626|NCT02512575|FG002|Participant Flow|AZD9567 - 20 mg|In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
11213204|NCT02284867|FG000|Participant Flow|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213205|NCT02284867|FG001|Participant Flow|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213206|NCT02284867|OG000|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213207|NCT02284867|OG001|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213208|NCT02284867|EG000|Reported Event|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213209|NCT02284867|EG001|Reported Event|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
11213210|NCT02284880|BG000|Baseline|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
11213211|NCT02284880|BG001|Baseline|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
11213212|NCT02284880|BG002|Baseline|Total|Total of all reporting groups
11213213|NCT02284880|FG000|Participant Flow|400 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
11213214|NCT02284880|FG001|Participant Flow|400 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
11213215|NCT02284880|FG002|Participant Flow|800 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
11213216|NCT02284880|FG003|Participant Flow|800 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
11213217|NCT02284880|OG000|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
11213218|NCT02284880|OG001|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
11213219|NCT02284880|EG000|Reported Event|Before Treatment|Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
11213220|NCT02284880|EG001|Reported Event|400 mg Tablet of ESL (MF)|400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
11213221|NCT02284880|EG002|Reported Event|400 mg Tablet of ESL (TBM)|400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
11213222|NCT02284880|EG003|Reported Event|800 mg Tablet of ESL (MF)|800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
11244627|NCT02512575|FG003|Participant Flow|AZD9567 - 40 mg|In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
11213223|NCT02284880|EG004|Reported Event|800 mg Tablet of ESL (TBM)|800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
11213224|NCT02284880|EG005|Reported Event|After Follow-up Visit|After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
11213225|NCT02284893|BG000|Baseline|SAXA + DAPA + MET|Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
11213226|NCT02284893|BG001|Baseline|SITA + MET|Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
11213227|NCT02284893|BG002|Baseline|Total|Total of all reporting groups
11213228|NCT02284893|FG000|Participant Flow|SAXA + DAPA + MET|Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
11213229|NCT02284893|FG001|Participant Flow|SITA + MET|Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
11213230|NCT02284893|OG000|Outcome|Saxagliptin + Dapagliflozin + Metformin Group|Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules
11213231|NCT02284893|OG001|Outcome|SITA + MET|Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
11213232|NCT02284893|EG000|Reported Event|SAXA + DAPA + MET|Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
11213233|NCT02284893|EG001|Reported Event|Sita + Met|Placebo tablet matching the saxagliptin 5-mg tablet+Placebo tablet matching the dapagliflozin 10-mg tablet+Sitagliptin 100-mg capsules+Metformin background therapy
11213234|NCT02285010|BG000|Baseline|Placebo|"Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213235|NCT02285010|BG001|Baseline|Pregabalin|"Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213236|NCT02285010|BG002|Baseline|Total|Total of all reporting groups
11213237|NCT02285010|FG000|Participant Flow|Placebo|"Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213238|NCT02285010|FG001|Participant Flow|Pregabalin|"Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213239|NCT02285010|OG000|Outcome|Placebo|"Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213240|NCT02285010|OG001|Outcome|Pregabalin|"Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213241|NCT02285010|EG000|Reported Event|Placebo|"Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11213242|NCT02285010|EG001|Reported Event|Pregabalin|"Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
11215534|NCT02300025|BG002|Baseline|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11244628|NCT02512575|FG004|Participant Flow|AZD9567 - 80 mg|In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
11244629|NCT02512575|FG005|Participant Flow|AZD9567 - 100 mg|In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
11244630|NCT02512575|FG006|Participant Flow|AZD9567 - 125 mg|In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
11244631|NCT02512575|FG007|Participant Flow|AZD9567 - 155 mg|In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
11244632|NCT02512575|FG008|Participant Flow|Prednisolone - 60 mg|In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
11244633|NCT02512575|FG009|Participant Flow|Pooled Placebo|In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
11244634|NCT02512575|OG000|Outcome|AZD9567 - 2 mg|In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
11244635|NCT02512575|OG001|Outcome|AZD9567 - 10 mg|In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
11244636|NCT02512575|OG002|Outcome|AZD9567 - 20 mg|In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
11244637|NCT02512575|OG003|Outcome|AZD9567 - 40 mg|In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
11244638|NCT02512575|OG004|Outcome|AZD9567 - 80 mg|In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
11244639|NCT02512575|OG005|Outcome|AZD9567 - 100 mg|In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
11244640|NCT02512575|OG006|Outcome|AZD9567 - 125 mg|In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
11244641|NCT02512575|OG007|Outcome|AZD9567 - 155 mg|In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
11244642|NCT02512575|OG008|Outcome|Prednisolone - 60 mg|In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
11244643|NCT02512575|OG009|Outcome|Pooled Placebo|In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
11244644|NCT02512575|EG000|Reported Event|AZD9567 - 2 mg|In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
11244645|NCT02512575|EG001|Reported Event|AZD9567 - 10 mg|In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
11244646|NCT02512575|EG002|Reported Event|AZD9567 - 20 mg|In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
11244647|NCT02512575|EG003|Reported Event|AZD9567 - 40 mg|In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
11244648|NCT02512575|EG004|Reported Event|AZD9567 - 80 mg|In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
11244649|NCT02512575|EG005|Reported Event|AZD9567 - 100 mg|In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
11244650|NCT02512575|EG006|Reported Event|AZD9567 - 125 mg|In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
11244651|NCT02512575|EG007|Reported Event|AZD9567 - 155 mg|In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
11244652|NCT02512575|EG008|Reported Event|Prednisolone - 60 mg|In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
11244653|NCT02512575|EG009|Reported Event|Pooled Placebo|In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
11244654|NCT02512679|BG000|Baseline|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
11244655|NCT02512679|FG000|Participant Flow|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
11244656|NCT02512679|FG001|Participant Flow|Cyclophosphamide Dose Level 2|"De-escalation of Cyclophosphamide given by Intravenous (IV) at a total dose of 70 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 75 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days. After ten patients the de-escalation will begin if the stopping rule is not met."
11244657|NCT02512679|OG000|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
11286267|NCT02885506|OG007|Outcome|Pooled Placebo|"Placebo capsule oral administration~Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug."
11213243|NCT02285023|BG000|Baseline|Chronic Idiopathic Urticaria Patients|"Evaluation by the Urticaria Activity Score (UAS7)~Fill the DLQI and CU-Q2oL questionnaire~CU-Q2oL: The patients diagnosed as chronic idiopathic urticaria will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home.~At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up.~At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire."
11213244|NCT02285023|FG000|Participant Flow|CU-Q2oL|"Evaluation by the Urticaria Activity Score (UAS7)~Fill the DLQI and CU-Q2oL questionnaire~CU-Q2oL: The patients will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home.~At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up.~At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire."
11213245|NCT02285023|OG000|Outcome|Extraction Sums of Square Loading (% of Variance)|% of Variance - This column contains the percent of total variance accounted for by each factor.
11213246|NCT02285023|OG001|Outcome|Rotation Sums of Squared Loading (% of Variance)|"The % of variance column tells you how much of the total variability (in all of the variables together) can be accounted for by each of these summary scales or factors."
11213247|NCT02285023|OG000|Outcome|Mean Score of Thai CUQ2oL at Baseline|It is the sum of individual scores divided by the number of individuals. Minimum and maximum of total CUQ2oL scores are 0 and 100, respectively.
11213248|NCT02285023|OG001|Outcome|Mean Score of Thai DLQI at Baseline|It is the sum of individual scores divided by the number of individuals. Minimum and maximum of total DLQI scores are 0 and 30, respectively.
11213249|NCT02285023|OG000|Outcome|Responder (Mean)|Mean score of the Thai CU-Q2oL of patients who had reduction in DLQI scores higher or equal to 5 were defined as responders.
11213250|NCT02285023|OG001|Outcome|Non-responders (Mean)|Mean score of the Thai CU-Q2oL of patients who had reduction in DLQI scores less than 5 were defined as non-responders.
11213251|NCT02285023|OG000|Outcome|Area Under the Curve|"Patients who had reduction in DLQI scores higher or equal to 5 were defined as responders.~Patients who had reduction in DLQI scores less than 5 were defined as non-responders."
11213252|NCT02285023|EG000|Reported Event|Chronic Idiopathic Urticaria|Patients diagnosed as chronic idiopathic urticarial were enrolled.
11213253|NCT02285153|BG000|Baseline|Acetylsalicylic Acid Lysinate|"100mg Acetylsalicylic Acid~Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day"
11213254|NCT02285153|BG001|Baseline|0.9% Sodium-chloride Solution|"0.9% sodium-chloride solution~0.9% sodium-chloride solution: Placebo, intravenously administered, daily"
11213255|NCT02285153|BG002|Baseline|Total|Total of all reporting groups
11213256|NCT02285153|FG000|Participant Flow|Acetylsalicylic Acid Lysinate|"100mg Acetylsalicylic Acid~Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day"
11213257|NCT02285153|FG001|Participant Flow|0.9% Sodium-chloride Solution|"0.9% sodium-chloride solution~0.9% sodium-chloride solution: Placebo, intravenously administered, daily"
11213258|NCT02285153|OG000|Outcome|Acetylsalicylic Acid Lysinate|"100mg Acetylsalicylic Acid~Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day"
11213259|NCT02285153|OG001|Outcome|0.9% Sodium-chloride Solution|"0.9% sodium-chloride solution~0.9% sodium-chloride solution: Placebo, intravenously administered, daily"
11213260|NCT02285153|EG000|Reported Event|Acetylsalicylic Acid Lysinate|"100mg Acetylsalicylic Acid~Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day"
11213261|NCT02285153|EG001|Reported Event|0.9% Sodium-chloride Solution|"0.9% sodium-chloride solution~0.9% sodium-chloride solution: Placebo, intravenously administered, daily"
11213262|NCT02285283|BG000|Baseline|Placebo|"2 capsules by mouth twice a day for 24 weeks~Placebo"
11213263|NCT02285283|BG001|Baseline|Itraconazole|"Two 100mg capsules by mouth twice a day for 24 weeks~Itraconazole"
11213264|NCT02285283|BG002|Baseline|Total|Total of all reporting groups
11213265|NCT02285283|FG000|Participant Flow|Placebo|"2 capsules by mouth twice a day for 24 weeks~Placebo"
11213266|NCT02285283|FG001|Participant Flow|Itraconazole|"Two 100mg capsules by mouth twice a day for 24 weeks~Itraconazole"
11213267|NCT02285283|OG000|Outcome|Placebo|"2 capsules by mouth twice a day for 24 weeks~Placebo"
11213268|NCT02285283|OG001|Outcome|Itraconazole|"Two 100mg capsules by mouth twice a day for 24 weeks~Itraconazole"
11213269|NCT02285283|EG000|Reported Event|Placebo|"2 capsules by mouth twice a day for 24 weeks~Placebo"
11213270|NCT02285283|EG001|Reported Event|Itraconazole|"Two 100mg capsules by mouth twice a day for 24 weeks~Itraconazole"
11213271|NCT02285361|BG000|Baseline|GIOTRIF®|GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water.
11213272|NCT02285361|FG000|Participant Flow|GIOTRIF®|GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water.
11213273|NCT02285361|OG000|Outcome|GIOTRIF®|GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water.
11286268|NCT02885506|OG008|Outcome|Fasted Cohort|"A single oral dose of 250 mg of P218 under fasted conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11244658|NCT02512679|EG000|Reported Event|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
11244659|NCT02512783|BG000|Baseline|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244660|NCT02512783|BG001|Baseline|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244661|NCT02512783|BG002|Baseline|Total|Total of all reporting groups
11244662|NCT02512783|FG000|Participant Flow|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244663|NCT02512783|FG001|Participant Flow|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244664|NCT02512783|OG000|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244665|NCT02512783|OG001|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244666|NCT02512783|EG000|Reported Event|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244667|NCT02512783|EG001|Reported Event|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
11244668|NCT02512809|BG000|Baseline|Isoflurane Arm|"Pediatric patients, aged 0-5 years, diagnosed with hydrocephalus undergoing a surgical (non-bedside) shunting procedure with general anesthesia. Pts will receive a standardized general anesthetic with isoflurane.~Isoflurane"
11244669|NCT02512809|BG001|Baseline|Dexmedetomidine/Remifentanil Arm|"Pediatric patients, aged 0-5 years, diagnosed with hydrocephalus undergoing a surgical (non-bedside) shunting procedure with general anesthesia. Pts will receive a standardized general anesthetic with dexmedetomidine and remifentanil infusions..~Dexmedetomidine"
11244670|NCT02512809|BG002|Baseline|MRI Control Arm|Otherwise healthy pediatric patients, aged 0-5 years, undergoing MRI with general anesthesia for evaluation of non-neurologic disease. Patients will receive a standardized general anesthetic with isoflurane.
11244671|NCT02512809|BG003|Baseline|Total|Total of all reporting groups
11244672|NCT02512809|FG000|Participant Flow|MRI Control Arm|Otherwise healthy pediatric patients, aged 0-5 years, undergoing MRI with general anesthesia for evaluation of non-neurologic disease. Patients will receive a standardized general anesthetic with isoflurane.
11244673|NCT02512809|OG000|Outcome|MRI Control Arm|Otherwise healthy pediatric patients, aged 0-5 years, undergoing MRI with general anesthesia for evaluation of non-neurologic disease. Patients will receive a standardized general anesthetic with isoflurane.
11244674|NCT02512809|EG000|Reported Event|MRI Control Arm|Otherwise healthy pediatric patients, aged 0-5 years, undergoing MRI with general anesthesia for evaluation of non-neurologic disease. Patients will receive a standardized general anesthetic with isoflurane.
11244675|NCT02512861|BG000|Baseline|Bupivacaine|"Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery~Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs"
11244676|NCT02512861|BG001|Baseline|Placebo|"Normal Saline~Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs"
11244677|NCT02512861|BG002|Baseline|Total|Total of all reporting groups
11244678|NCT02512861|FG000|Participant Flow|Bupivacaine|"Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery~Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs"
11244679|NCT02512861|FG001|Participant Flow|Placebo|"Normal Saline~Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs"
11244680|NCT02512861|OG000|Outcome|Bupivacaine|"Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery~Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs"
11244681|NCT02512861|OG001|Outcome|Placebo|"Normal Saline~Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs"
11244682|NCT02512861|EG000|Reported Event|Bupivacaine|"Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery~Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs"
11244683|NCT02512861|EG001|Reported Event|Placebo|"Normal Saline~Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs"
11244684|NCT02512874|BG000|Baseline|Pulmonary Rehabilitation|"One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor.~Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation.~Dynamometer: Grip Test~DEXA: Body Composition Testing~Gait Speed Test: 15 foot walk test~Activity Monitor: Measures energy expenditure and activity~Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms."
11244685|NCT02512874|FG000|Participant Flow|Pulmonary Rehabilitation|"One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor.~Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation.~Dynamometer: Grip Test~DEXA: Body Composition Testing~Gait Speed Test: 15 foot walk test~Activity Monitor: Measures energy expenditure and activity~Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms."
11244686|NCT02512874|OG000|Outcome|Pulmonary Rehabilitation|"One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor.~Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation.~Dynamometer: Grip Test~DEXA: Body Composition Testing~Gait Speed Test: 15 foot walk test~Activity Monitor: Measures energy expenditure and activity~Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms."
11244687|NCT02512874|EG000|Reported Event|Pulmonary Rehabilitation|"One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, Dual-energy X-ray absorptiometry (DEXA) scans, Dynamometer and gait speed tests and activity measured through an activity monitor.~Pulmonary Rehabilitation: Measures of frailty taken before and after pulmonary rehabilitation.~Dynamometer: Grip Test~DEXA: Body Composition Testing~Gait Speed Test: 15 foot walk test~Activity Monitor: Measures energy expenditure and activity~Questionnaires: Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms."
11244688|NCT02512900|BG000|Baseline|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244689|NCT02512900|BG001|Baseline|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244690|NCT02512900|BG002|Baseline|TOTAL|Total of all reporting groups
11244691|NCT02512900|FG000|Participant Flow|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244692|NCT02512900|FG001|Participant Flow|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244693|NCT02512900|OG000|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244694|NCT02512900|OG001|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244695|NCT02512900|OG000|Outcome|MEDI9929|On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.
11244696|NCT02512900|EG000|Reported Event|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244697|NCT02512900|EG001|Reported Event|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
11244698|NCT02512965|BG000|Baseline|Standard Conventional Radiotherapy|"Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions~20 Gy in 5 fractions"
11244699|NCT02512965|BG001|Baseline|Stereotactic Body Radiotherapy|"Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions~Conventional SBRT: 24 Gy in 2 fractions"
11244700|NCT02512965|BG002|Baseline|Total|Total of all reporting groups
11244701|NCT02512965|FG000|Participant Flow|Standard Conventional Radiotherapy|"Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions~20 Gy in 5 fractions"
11244702|NCT02512965|FG001|Participant Flow|Stereotactic Body Radiotherapy|"Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions~Conventional SBRT: 24 Gy in 2 fractions"
11244703|NCT02512965|OG000|Outcome|Standard Conventional Radiotherapy|"Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions~20 Gy in 5 fractions"
11244704|NCT02512965|OG001|Outcome|Stereotactic Body Radiotherapy|"Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions~Conventional SBRT: 24 Gy in 2 fractions"
11244705|NCT02512965|EG000|Reported Event|Standard Conventional Radiotherapy|"Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions~20 Gy in 5 fractions"
11244706|NCT02512965|EG001|Reported Event|Stereotactic Body Radiotherapy|"Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions~Conventional SBRT: 24 Gy in 2 fractions"
11244707|NCT02513095|BG000|Baseline|Ryanodex Plus Standard of Care|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
11244708|NCT02513095|BG001|Baseline|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
11244709|NCT02513095|BG002|Baseline|Total|Total of all reporting groups
11244710|NCT02513095|FG000|Participant Flow|Active|Ryanodex plus Standard of Care
11244711|NCT02513095|FG001|Participant Flow|Control|Standard of Care Only
11244712|NCT02513095|OG000|Outcome|Ryanodex Plus Standard of Care|Ryanodex plus Standard of Care. Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.
11244713|NCT02513095|OG001|Outcome|Standard of Care|Standard of Care Only
11244714|NCT02513095|EG000|Reported Event|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
11244715|NCT02513095|EG001|Reported Event|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
11244716|NCT02513121|BG000|Baseline|Intervention Group|Low free sugar diet
11244717|NCT02513121|BG001|Baseline|Control Group|Habitual diet
11244718|NCT02513121|BG002|Baseline|Total|Total of all reporting groups
11244719|NCT02513121|FG000|Participant Flow|Intervention Group|Low free sugar diet
11244720|NCT02513121|FG001|Participant Flow|Control Group|Habitual diet
11244721|NCT02513121|OG000|Outcome|Intervention Group|Low free sugar diet
11244722|NCT02513121|OG001|Outcome|Control Group|Habitual diet
11244723|NCT02513121|OG000|Outcome|Intervention Group|Low free Sugar Diet
11244724|NCT02513121|OG001|Outcome|Control Group|Habitual Diet
11244725|NCT02513121|EG000|Reported Event|Intervention Group|Low free sugar diet
11244726|NCT02513121|EG001|Reported Event|Control Group|Habitual diet
11244727|NCT02513160|BG000|Baseline|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244728|NCT02513160|BG001|Baseline|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244729|NCT02513160|BG002|Baseline|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244730|NCT02513160|BG003|Baseline|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244731|NCT02513160|BG004|Baseline|Total|Total of all reporting groups
11244732|NCT02513160|FG000|Participant Flow|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244733|NCT02513160|FG001|Participant Flow|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244734|NCT02513160|FG002|Participant Flow|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244735|NCT02513160|FG003|Participant Flow|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244736|NCT02513160|OG000|Outcome|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244737|NCT02513160|OG001|Outcome|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244738|NCT02513160|OG002|Outcome|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244739|NCT02513160|OG003|Outcome|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
11244740|NCT02513160|EG000|Reported Event|Run-in Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for up to 30 days of the single-blind Run-in Period.
11244741|NCT02513160|EG001|Reported Event|Placebo|Pooled breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for the 6 weeks of the double-blind Treatment Period.
11244742|NCT02513160|EG002|Reported Event|BAI 320 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period.
11244743|NCT02513160|EG003|Reported Event|BAI 640 mcg/Day|Beclomethasone dipropionate breath-actuated inhaler (BAI), 4 inhalations (80 mcg/inhalation), twice daily for a total daily dose of 640 mcg for the 6 weeks of the double-blind Treatment Period.
11244744|NCT02513160|EG004|Reported Event|MDI 320 mcg/Day|Beclomethasone dipropionate metered-dose inhaler (MDI), 4 inhalations (40 mcg/inhalation), twice daily for a total daily dose of 320 mcg for the 6 weeks of the double-blind Treatment Period.
11244745|NCT02513212|BG000|Baseline|Oxalate Liquid, SnF2 Paste, Manual Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Manual toothbrush: Marketed manual toothbrush"
11244746|NCT02513212|BG001|Baseline|Oxalate Liquid, SnF2 Paste, Power Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Power toothbrush: Marketed power toothbrush"
11244747|NCT02513212|BG002|Baseline|Total|Total of all reporting groups
11244748|NCT02513212|FG000|Participant Flow|Oxalate Liquid, SnF2 Paste, Manual Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Manual toothbrush: Marketed manual toothbrush"
11244749|NCT02513212|FG001|Participant Flow|Oxalate Liquid, SnF2 Paste, Power Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Power toothbrush: Marketed power toothbrush"
11244750|NCT02513212|OG000|Outcome|Oxalate Liquid, SnF2 Paste, Manual Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Manual toothbrush: Marketed manual toothbrush"
11244751|NCT02513212|OG001|Outcome|Oxalate Liquid, SnF2 Paste, Power Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Power toothbrush: Marketed power toothbrush"
11244752|NCT02513212|EG000|Reported Event|Oxalate Liquid, SnF2 Paste, Manual Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Manual toothbrush: Marketed manual toothbrush"
11244753|NCT02513212|EG001|Reported Event|Oxalate Liquid, SnF2 Paste, Power Toothbrush|"Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush~Potassium Oxalate: Professionally applied liquid~Stannous fluoride paste: SnF2 Paste~Power toothbrush: Marketed power toothbrush"
11244754|NCT02513446|BG000|Baseline|Sequence RT|"Treatment R (BI 1026706 alone):~Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.~Treatment T (itraconazole + BI 1026706):~Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).~The single dose administrations of BI 1026706 in treatments R and T were separated by a wash-out period of at least 10 days."
11244755|NCT02513446|BG001|Baseline|Sequence TR|"Treatment T (itraconazole + BI 1026706):~Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).~Treatment R (BI 1026706 alone):~Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.~The single dose administrations of BI 1026706 in treatments T and R were separated by a wash-out period of at least 10 days."
11244756|NCT02513446|BG002|Baseline|Total|Total of all reporting groups
11286269|NCT02885506|OG009|Outcome|Fed Cohort|"A single oral dose of 250 mg of P218 under fed conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286270|NCT02885506|OG008|Outcome|Fed - Fasted|"A single oral dose of 250 mg of P218 under fed then fasted conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11244757|NCT02513446|FG000|Participant Flow|Sequence RT|"Treatment R (BI 1026706 alone):~Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.~Treatment T (itraconazole + BI 1026706):~Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).~The single dose administrations of BI 1026706 in treatments R and T were separated by a wash-out period of at least 10 days."
11244758|NCT02513446|FG001|Participant Flow|Sequence TR|"Treatment T (itraconazole + BI 1026706):~Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).~Treatment R (BI 1026706 alone):~Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.~The single dose administrations of BI 1026706 in treatments T and R were separated by a wash-out period of at least 10 days."
11244759|NCT02513446|OG000|Outcome|Treatment R (BI 1026706 Alone)|Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
11244760|NCT02513446|OG001|Outcome|Treatment T (Itraconazole + BI 1026706)|Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
11244761|NCT02513446|EG000|Reported Event|Treatment R (BI 1026706 Alone)|Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
11244762|NCT02513446|EG001|Reported Event|Treatment T (Itraconazole + BI 1026706)|Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
11244763|NCT02513446|EG002|Reported Event|Total|Total
11244764|NCT02513459|BG000|Baseline|All Risankizumab|Participants who received at least one dose of risankizumab in the current study
11244765|NCT02513459|FG000|Participant Flow|All Risankizumab|Participants who received at least one dose of risankizumab in the current study
11244766|NCT02513459|OG000|Outcome|Risankizumab 600 mg IV|Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained
11244767|NCT02513459|OG001|Outcome|Risankizumab 180 mg SC|Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
11244768|NCT02513459|OG002|Outcome|All Risankizumab|Participants who received at least one dose of risankizumab in the current study
11244769|NCT02513459|OG000|Outcome|Risankizumab 180 mg SC|Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
11244770|NCT02513459|EG000|Reported Event|Risankizumab 600 mg IV|Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained
11244771|NCT02513459|EG001|Reported Event|Risankizumab 180 mg SC|Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
11244772|NCT02513459|EG002|Reported Event|All Risankizumab|Participants who received at least one dose of risankizumab in the current study
11244773|NCT02513498|BG000|Baseline|Treatment (Ixazomib Citrate)|Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
11244774|NCT02513498|FG000|Participant Flow|Treatment (Ixazomib Citrate)|Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
11244775|NCT02513498|OG000|Outcome|Treatment (Ixazomib Citrate)|Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
11244776|NCT02513498|OG000|Outcome|Response Evaluated by MD|Participants who receive ixazomib citrate
11244777|NCT02513498|OG001|Outcome|Response Evaluated by NIH|Participants who receive ixazomib citrate
11244778|NCT02513498|EG000|Reported Event|Treatment (Ixazomib Citrate)|Patients receive ixazomib citrate PO once weekly on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive an additional 6 courses of ixazomib citrate.
11244779|NCT02513550|BG000|Baseline|80 mg Ixekizumab Q4W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244780|NCT02513550|BG001|Baseline|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244781|NCT02513550|BG002|Baseline|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244782|NCT02513550|BG003|Baseline|80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244783|NCT02513550|BG004|Baseline|80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244784|NCT02513550|BG005|Baseline|80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244785|NCT02513550|BG006|Baseline|Total|Total of all reporting groups
11244786|NCT02513550|FG000|Participant Flow|80 mg Ixekizumab Q4W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244787|NCT02513550|FG001|Participant Flow|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244788|NCT02513550|FG002|Participant Flow|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244789|NCT02513550|FG003|Participant Flow|80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244790|NCT02513550|FG004|Participant Flow|80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244791|NCT02513550|FG005|Participant Flow|80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244792|NCT02513550|OG000|Outcome|80 mg Ixekizumab Q4W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244793|NCT02513550|OG001|Outcome|80 mg Ixekizumab Q4W/Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244794|NCT02513550|OG002|Outcome|80 mg Ixekizumab Q2W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244795|NCT02513550|OG000|Outcome|80 mg Ixekizumab Q4W|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind..
11244796|NCT02513550|OG000|Outcome|80 mg Ixekizumab Q4W Continuous|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244797|NCT02513550|OG001|Outcome|80 mg Ixekizumab Q4W/Q2W No Step|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244798|NCT02513550|OG002|Outcome|80 mg Ixekizumab Q4W/Q2W Step up|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244799|NCT02513550|OG003|Outcome|80 mg Ixekizumab Q2W Continuous|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244800|NCT02513550|EG000|Reported Event|Ixekizumab 80 mg Q4W - Treatment Period|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244801|NCT02513550|EG001|Reported Event|80 mg Ixekizumab Q4W/Q2W - Treatment Period|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244802|NCT02513550|EG002|Reported Event|80 mg Ixekizumab Q2W - Treatment Period|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244803|NCT02513550|EG003|Reported Event|80 mg Ixekizumab Q4W - Post-Treatment Period|Participants didn't receive any intervention.
11244804|NCT02513550|EG004|Reported Event|80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period|Participants didn't receive any intervention.
11244805|NCT02513550|EG005|Reported Event|80 mg Ixekizumab Q2W - Post-Treatment Period|Participants didn't receive any intervention.
11244806|NCT02513550|EG006|Reported Event|80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244807|NCT02513550|EG007|Reported Event|80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
11244808|NCT02513550|EG008|Reported Event|80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort|160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
11244809|NCT02513550|EG009|Reported Event|80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort|Participants didn't receive any intervention.
11244810|NCT02513550|EG010|Reported Event|80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort|Participants didn't receive any intervention.
11244811|NCT02513550|EG011|Reported Event|80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort|Participants didn't receive any intervention.
11244812|NCT02513641|BG000|Baseline|Moderate Hypoxia|"2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.~Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of ~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only."
11244813|NCT02513641|FG000|Participant Flow|Moderate Hypoxia|"2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.~Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of ~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only."
11244814|NCT02513641|OG000|Outcome|Moderate Hypoxia|"2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.~Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of ~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only."
11244815|NCT02513641|EG000|Reported Event|Moderate Hypoxia|"2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (~2,400 meters) using the Hypoxico Altitude Training Systems device.~Hypoxico Altitude Training Systems: Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of ~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only."
11244816|NCT02513719|BG000|Baseline|XIENCE PRIME SV Everolimus Eluting Coronary Stent|"Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent~XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent"
11244817|NCT02513719|FG000|Participant Flow|XIENCE PRIME SV Everolimus Eluting Coronary Stent|"Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent~XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent"
11244818|NCT02513719|OG000|Outcome|XIENCE PRIME SV Everolimus Eluting Coronary Stent|"Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent~XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent"
11244819|NCT02513719|EG000|Reported Event|XIENCE PRIME SV Everolimus Eluting Coronary Stent|"Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent~XIENCE PRIME SV Everolimus Eluting Coronary Stent: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent"
11244820|NCT02513732|BG000|Baseline|XIENCE Xpedition 2.25 mm Stent Arm|Patients receiving XIENCE Xpedition 2.25 mm stent
11244821|NCT02513732|FG000|Participant Flow|XIENCE Xpedition 2.25 mm Stent Arm|Patients receiving XIENCE Xpedition 2.25 mm stent
11244822|NCT02513732|OG000|Outcome|XIENCE Xpedition 2.25 mm Stent Arm|Patients receiving XIENCE Xpedition 2.25 mm stent
11244823|NCT02513732|EG000|Reported Event|XIENCE Xpedition 2.25 mm Stent Arm|Patients receiving XIENCE Xpedition 2.25 mm stent
11244824|NCT02513745|BG000|Baseline|Conventional|"Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.~Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery."
11244825|NCT02513745|BG001|Baseline|Refractive Cataract Suite (Verion + ORA)|"Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.~Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry."
11244826|NCT02513745|BG002|Baseline|Total|Total of all reporting groups
11244827|NCT02513745|FG000|Participant Flow|Conventional|"Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.~Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery."
11244828|NCT02513745|FG001|Participant Flow|Refractive Cataract Suite (Verion + ORA)|"Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.~Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry."
11244829|NCT02513745|OG000|Outcome|Conventional|"Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.~Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery."
11244830|NCT02513745|OG001|Outcome|Refractive Cataract Suite (Verion + ORA)|"Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.~Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry."
11244831|NCT02513745|EG000|Reported Event|Conventional|"Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.~Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery."
11244832|NCT02513745|EG001|Reported Event|Refractive Cataract Suite (Verion + ORA)|"Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.~Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry."
11244833|NCT02513771|BG000|Baseline|Sitagliptin Arm|Sitagliptin: 100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up
11244834|NCT02513771|BG001|Baseline|Placebo Arm|Placebo for sitagliptin: One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.
11244835|NCT02513771|BG002|Baseline|Total|Total of all reporting groups
11244836|NCT02513771|FG000|Participant Flow|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
11244837|NCT02513771|FG001|Participant Flow|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
11244838|NCT02513771|OG000|Outcome|Sitagliptin Arm|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
11244839|NCT02513771|OG001|Outcome|Placebo Arm|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
11244840|NCT02513771|EG000|Reported Event|Sitagliptin|Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
11244841|NCT02513771|EG001|Reported Event|Placebo|Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
11244842|NCT02513823|BG000|Baseline|Intervention|"2,000 IU of vitamin D given to African American women for 10 weeks~2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks"
11244843|NCT02513823|FG000|Participant Flow|Intervention|"2,000 IU of vitamin D given to African American women for 10 weeks~2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks"
11244844|NCT02513823|OG000|Outcome|Intervention|"2,000 IU of vitamin D given to African American women for 10 weeks~2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks"
11244845|NCT02513823|EG000|Reported Event|Intervention|"2,000 IU of vitamin D given to African American women for 10 weeks~2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks"
11244846|NCT02513940|BG000|Baseline|All Study Participants|Men 65 years of age or older were enrolled. Exclusion criteria were: prostate cancer; history of prostate or breast cancer; benign prostatic hyperplasia; weight < 60 kg or > 135 kg; serum potassium < 3.6 mEq/L; serum magnesium < 1.8 mg/dL; hematocrit < 26%; hepatic transaminases > 3x upper limit of normal; baseline Bazett's-corrected QTc interval > 450 ms; heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%); family or personal history of long QT syndrome, arrhythmias or sudden cardiac death; permanently paced ventricular rhythm; concomitant use of any QT interval-prolonging drug or strong non-QT interval-prolonging cytochrome P450 3A inhibitors.
11244847|NCT02513940|FG000|Participant Flow|Testosterone - Progesterone - Placebo|"Subjects received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days. After a washout of at least 13 days, they then received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days. After a washout period of at least 13 days, they then received transdermal placebo gel once daily every morning for 7 days and oral placebo once daily every morning x 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244848|NCT02513940|FG001|Participant Flow|Testosterone - Placebo - Progesterone|"Subjects received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days. After a washout of at least 13 days, they then received transdermal placebo gel once daily every morning for 7 days and oral placebo ( 2 capsules) once daily every morning x 7 days. After a washout period of at least 13 days, they then received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days.~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244849|NCT02513940|FG002|Participant Flow|Progesterone - Testosterone - Placebo|"Subjects received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days. After a washout period of at least 13 days, they then received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days. After a washout period of at least 13 days, they then received transdermal placebo gel once daily every morning for 7 days and oral placebo (2 capsules) once daily every morning x 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244850|NCT02513940|FG003|Participant Flow|Progesterone - Placebo - Testosterone|"Subjects received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days. After a washout period of at least 13 days, they then received transdermal placebo gel once daily every morning for 7 days and oral placebo (2 capsules) once daily every morning x 7 days. After a washout period of at least 13 days, they then received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days.~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244851|NCT02513940|FG004|Participant Flow|Placebo - Testosterone - Progesterone|"Subjects received transdermal placebo gel once daily every morning for 7 days and oral placebo once daily every morning x 7 days. After a washout period of at least 13 days, they then received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days. After a washout period of at least 13 days, they then received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days.~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244852|NCT02513940|FG005|Participant Flow|Placebo - Progesterone - Testosterone|"Subjects received transdermal placebo gel once daily every morning for 7 days and oral placebo once daily every morning x 7 days. After a washout period of at least 13 days, they then received oral progesterone 400 mg (2 x 200 mg capsules) once every evening for 7 days and transdermal placebo gel once daily every morning for 7 days. After a washout period of at least 13 days, they then received transdermal testosterone gel 1% 100 mg once daily in the morning and two (2) oral placebo capsules x 7 days.~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244853|NCT02513940|OG000|Outcome|Testosterone|"Testosterone gel 1% 100 mg daily x 7 days~Testosterone: Subjects will receive transdermal testosterone gel 1% 100 mg daily for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244854|NCT02513940|OG001|Outcome|Progesterone|"Progesterone 400 mg orally daily x 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244855|NCT02513940|OG002|Outcome|Placebo|"Dual matching placebo capsules and placebo topical gel every day x 7 days~Placebo~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244856|NCT02513940|OG000|Outcome|Testosterone|"Testosterone gel 1% 100 mg daily x 7 days Oral placebo capsules once daily for 7 days~Testosterone: Subjects will receive transdermal testosterone gel 1% 100 mg daily for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244857|NCT02513940|OG001|Outcome|Progesterone|"Progesterone 400 mg orally daily x 7 days Transdermal placebo gel once daily for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244858|NCT02513940|EG000|Reported Event|Testosterone|"Testosterone gel 1% 100 mg daily x 7 days Oral placebo capsules once daily for 7 days~Testosterone: Subjects will receive transdermal testosterone gel 1% 100 mg daily for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244859|NCT02513940|EG001|Reported Event|Progesterone|"Progesterone 400 mg orally daily x 7 days Transdermal placebo gel once daily for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244860|NCT02513940|EG002|Reported Event|Placebo|"Dual matching placebo capsules and placebo topical gel every day x 7 days~Placebo~Ibutilide: Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval"
11244861|NCT02514044|BG000|Baseline|All Study Participants|"10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day Dexedrine: 10 mg immediate release of Dexedrine Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy~Placebo, 1.5 mA anodal tDCS, and speech therapy for 1 day Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy Placebo"
11244862|NCT02514044|FG000|Participant Flow|Dexedrine+tDCS+Speech Therapy, Then Placebo+tDCS+Speech Therap|"10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day Dexedrine: 10 mg immediate release of Dexedrine Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy~Placebo, 1.5 mA anodal tDCS, and speech therapy for 1 day Active tDCS: 1.5 mA tDCS anodal tDCS Speech Therapy: 60 min of speech therapy Placebo"
11244863|NCT02514044|OG000|Outcome|Dexedrine+tDCS+Speech Therapy|The subjects received 10 mg D-AMP 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
11244864|NCT02514044|OG001|Outcome|Placebo+tDCS+Speech Therapy|The subjects received placebo 30 minutes before the 60 minutes of SLT; first 20 min is simultaneous tDCS stimulation in this experiment/arm.
11244865|NCT02514044|OG000|Outcome|Dexedrine+tDCS+Speech Therapy|"10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day~Dexedrine: 10 mg immediate release of Dexedrine~Active tDCS: 1.5 mA tDCS anodal tDCS~Speech Therapy: 60 min of speech therapy"
11244866|NCT02514044|OG001|Outcome|Placebo+tDCS+Speech Therapy|"1.5 mA anodal tDCS, and speech therapy for 1 day~Active tDCS: 1.5 mA tDCS anodal tDCS~Speech Therapy: 60 min of speech therapy~Placebo"
11244867|NCT02514044|EG000|Reported Event|D-AMP+tDCS+Speech Therapy|The subjects received 10 mg of D-AMP medication 30 minutes before the simultaneous tDCS (first 20 min) and 60 min of SLT in this experiment.
11244868|NCT02514044|EG001|Reported Event|Placebo+tDCS+Speech Therapy|The subjects received placebo medication 30 minutes before the simultaneous tDCS (first 20 min) and 60 min of SLT in this experiment.
11244869|NCT02514070|BG000|Baseline|Arm 1: EPA-rich Fish Oil, Then DHA-rich Fish Oil|Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244870|NCT02514070|BG001|Baseline|Arm 2: DHA-rich Fish Oil, Then EPA-rich Fish Oil|Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244871|NCT02514070|BG002|Baseline|Total|Total of all reporting groups
11244872|NCT02514070|FG000|Participant Flow|Arm 1: EPA-rich Fish Oil Then DHA-rich Fish Oil|Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244873|NCT02514070|FG001|Participant Flow|Arm 2: DHA-rich Fish Oil Then EPA-rich Fish Oil|Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks, followed by an 8-week washout period. Then Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244874|NCT02514070|OG000|Outcome|Baseline|All study participants.
11244875|NCT02514070|OG001|Outcome|EPA-rich Fish Oil|Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244876|NCT02514070|OG002|Outcome|DHA-rich Fish Oil Arm|Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244877|NCT02514070|OG000|Outcome|Baseline|All study participants
11244878|NCT02514070|OG002|Outcome|DHA-rich Fish Oil|Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244879|NCT02514070|EG000|Reported Event|EPA-rich Fish Oil|Eicosapentaenoic acid (EPA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244880|NCT02514070|EG001|Reported Event|DHA-rich Fish Oil|Docosahexaenoic acid (DHA)-rich fish oil 4 capsules 3 times per day after meal for a total of 3g per day for 6 weeks.
11244881|NCT02514070|EG002|Reported Event|Washout Period|8 week washout period to occur between week 6 and week 14. No study supplement taken by subject at this time.
11244882|NCT02514122|BG000|Baseline|Ketamine|"Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.~Ketamine: Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244883|NCT02514122|BG001|Baseline|Saline|"Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.~Saline: Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244884|NCT02514122|BG002|Baseline|Total|Total of all reporting groups
11244885|NCT02514122|FG000|Participant Flow|Ketamine|"Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.~Ketamine: Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244886|NCT02514122|FG001|Participant Flow|Saline|"Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.~Saline: Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244887|NCT02514122|OG000|Outcome|Ketamine|"Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.~Ketamine: Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244888|NCT02514122|OG001|Outcome|Saline|"Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.~Saline: Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244889|NCT02514122|EG000|Reported Event|Ketamine|"Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.~Ketamine: Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.~Ketamine participants had more hallucinations than saline group."
11244890|NCT02514122|EG001|Reported Event|Saline|"Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.~Saline: Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections."
11244891|NCT02514174|BG000|Baseline|Afatinib|"Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose~All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.~Mode of administration: Orally one film-coated tablet, once daily"
11244892|NCT02514174|FG000|Participant Flow|Afatinib|"Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose~All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.~Mode of administration: Orally one film-coated tablet, once daily"
11244893|NCT02514174|OG000|Outcome|Afatinib|"Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose~All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.~Mode of administration: Orally one film-coated tablet, once daily"
11244894|NCT02514174|EG000|Reported Event|Afatinib 30 mg|"Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose~All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.~Mode of administration: Orally one film-coated tablet, once daily"
11244895|NCT02514473|BG000|Baseline|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
11244896|NCT02514473|BG001|Baseline|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
11244897|NCT02514473|BG002|Baseline|Total|Total of all reporting groups
11244898|NCT02514473|FG000|Participant Flow|Placebo|Participants received placebo matched to LUM in combination with IVA fixed-dose combination (FDC) tablets orally every 12 hours (q12h) for 24 weeks.
11244899|NCT02514473|FG001|Participant Flow|LUM/IVA|Participants received LUM 200 milligram (mg) in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
11244900|NCT02514473|OG000|Outcome|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
11244901|NCT02514473|OG001|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
11244902|NCT02514473|OG000|Outcome|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
11244903|NCT02514473|EG000|Reported Event|Placebo|Participants received placebo matched to LUM in combination with IVA FDC tablets orally q12h for 24 weeks.
11244904|NCT02514473|EG001|Reported Event|LUM/IVA|Participants received LUM 200 mg in combination with IVA 250 mg FDC tablets orally q12h for 24 weeks.
11244905|NCT02514551|BG000|Baseline|12mg/kg Ramucirumab + 80 mg/m² Paclitaxel|12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244906|NCT02514551|BG001|Baseline|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244907|NCT02514551|BG002|Baseline|Total|Total of all reporting groups
11244908|NCT02514551|FG000|Participant Flow|12mg/kg Ramucirumab + 80 mg/m² Paclitaxel|12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.
11244909|NCT02514551|FG001|Participant Flow|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244910|NCT02514551|OG000|Outcome|I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel|12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244911|NCT02514551|OG000|Outcome|12mg/kg Ramucirumab + 80 mg/m² Paclitaxel|12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244912|NCT02514551|OG001|Outcome|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244913|NCT02514551|EG000|Reported Event|12mg/kg Ramucirumab + 80 mg/m² Paclitaxel|12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244914|NCT02514551|EG001|Reported Event|8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel|8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
11244915|NCT02514577|BG000|Baseline|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244916|NCT02514577|BG001|Baseline|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244917|NCT02514577|BG002|Baseline|Total|Total of all reporting groups
11244918|NCT02514577|FG000|Participant Flow|IDP-122 Lotion|Participants applied IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
11244919|NCT02514577|FG001|Participant Flow|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244920|NCT02514577|OG000|Outcome|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244921|NCT02514577|OG001|Outcome|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244922|NCT02514577|EG000|Reported Event|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244923|NCT02514577|EG001|Reported Event|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244924|NCT02514746|BG000|Baseline|Group A: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244925|NCT02514746|BG001|Baseline|Group B: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244926|NCT02514746|BG002|Baseline|Total|Total of all reporting groups
11244927|NCT02514746|FG000|Participant Flow|Group A: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244928|NCT02514746|FG001|Participant Flow|Group B: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244929|NCT02514746|OG000|Outcome|Group A: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244930|NCT02514746|OG001|Outcome|Group B: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244931|NCT02514746|OG002|Outcome|Total|Participants previously vaccinated with CD-JEV received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244932|NCT02514746|EG000|Reported Event|Group A: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244933|NCT02514746|EG001|Reported Event|Group B: CD-JEV|Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244934|NCT02514746|EG002|Reported Event|Total|Participants previously vaccinated with CD-JEV received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination.
11244935|NCT02514772|BG000|Baseline|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A Proposed biosimilar rituximab"
11244936|NCT02514772|BG001|Baseline|Rituxan ® / MabThera ®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera)"
11244937|NCT02514772|BG002|Baseline|Total|Total of all reporting groups
11244938|NCT02514772|FG000|Participant Flow|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14)~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
11244939|NCT02514772|FG001|Participant Flow|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14)~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
11244940|NCT02514772|OG000|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
11286271|NCT02885506|OG009|Outcome|Fasted - Fed|"A single oral dose of 250 mg of P218 under fasted then fed conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11244941|NCT02514772|OG001|Outcome|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
11244942|NCT02514772|OG000|Outcome|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A Proposed biosimilar rituximab"
11244943|NCT02514772|OG001|Outcome|Rituxan ® / MabThera ®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera)"
11244944|NCT02514772|EG000|Reported Event|GP2013|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~GP2013 - A proposed biosimilar rituximab~Patients in this group are switched from originator rituximab (which they received before study participation) to GP2013"
11244945|NCT02514772|EG001|Reported Event|Rituxan® / MabThera®|"10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.~Originator rituximab - Rituxan ® or MabThera ® dependent on region of participation (USA patients receive Rituxan; EU patients receive MabThera).~Patients in this group receive same originator rituximab as they received before study participation"
11244946|NCT02514824|BG000|Baseline|Dose Level 1: MLN01283 3 mg (Phase 1)|"Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244947|NCT02514824|BG001|Baseline|Dose Level 2: MLN01283 4 mg (Phase 1)|"Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244948|NCT02514824|BG002|Baseline|Total|Total of all reporting groups
11244949|NCT02514824|FG000|Participant Flow|Dose Level 1: MLN01283 3 mg (Phase 1)|"Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244950|NCT02514824|FG001|Participant Flow|Dose Level 2: MLN01283 4 mg (Phase 1)|"Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244951|NCT02514824|FG002|Participant Flow|Dose Level 3: MLN01283 5 mg (Phase 1)|"Phase 1 dose level 3 participants receive MLN01283 5 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244952|NCT02514824|FG003|Participant Flow|MLN01283 RP2D (Phase 2)|"Phase 2 participants receive MLN01283 at the recommended phase 2 dose (RP2D) orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244953|NCT02514824|OG000|Outcome|All Phase 1 Participants|"Phase 1 participants received MLN01283 according to the established dose escalation schedule.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244954|NCT02514824|OG000|Outcome|Dose Level 1: MLN01283 3 mg (Phase 1)|"Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244955|NCT02514824|OG001|Outcome|Dose Level 2: MLN01283 4 mg (Phase 1)|"Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244956|NCT02514824|EG000|Reported Event|Dose Level 1: MLN01283 3 mg (Phase 1)|"Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244957|NCT02514824|EG001|Reported Event|Dose Level 2: MLN01283 4 mg (Phase 1)|"Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons."
11244958|NCT02514889|BG000|Baseline|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
11286272|NCT02885506|EG000|Reported Event|Cohort 1|"10 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286273|NCT02885506|EG001|Reported Event|Cohort 2|"30 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286274|NCT02885506|EG002|Reported Event|Cohort 3|"100 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11286275|NCT02885506|EG003|Reported Event|Cohort 4|"250 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11244959|NCT02514889|BG001|Baseline|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
11244960|NCT02514889|BG002|Baseline|Total|Total of all reporting groups
11244961|NCT02514889|FG000|Participant Flow|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
11244962|NCT02514889|FG001|Participant Flow|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
11244963|NCT02514889|OG000|Outcome|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
11244964|NCT02514889|OG001|Outcome|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
11244965|NCT02514889|EG000|Reported Event|Calorie-counting|"Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.~Calorie-counting: The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
11244966|NCT02514889|EG001|Reported Event|MyPlate|"Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.~MyPlate: The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
11244967|NCT02515045|BG000|Baseline|TriMoxiVanc One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan or Control group.~TriMoxiVanc group:~Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD.~Control group:~Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.~Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
11244968|NCT02515045|BG001|Baseline|TriMoxiVanc + Ilevro One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group.~TriMoxiVan + Ilevro group:~Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~Control group:~Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.~Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
11244969|NCT02515045|BG002|Baseline|Total|Total of all reporting groups
11244970|NCT02515045|FG000|Participant Flow|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
11244971|NCT02515045|FG001|Participant Flow|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
11244972|NCT02515045|FG002|Participant Flow|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
11244973|NCT02515045|OG000|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
11244974|NCT02515045|OG001|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
11244975|NCT02515045|OG002|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
11244976|NCT02515045|EG000|Reported Event|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
11244977|NCT02515045|EG001|Reported Event|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.~TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
11244978|NCT02515045|EG002|Reported Event|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.~Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.~Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.~Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
11244979|NCT02515058|BG000|Baseline|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
10820089|NCT00053846|OG000|Outcome|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
10820090|NCT00053846|OG001|Outcome|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
11213274|NCT02285361|EG000|Reported Event|GIOTRIF®|GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water.
11213275|NCT02285634|BG000|Baseline|Oxymetazoline 0.05%|"Oxymetazoline 0.05%~Oxymetazoline 0.05%: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213276|NCT02285634|BG001|Baseline|Phenylephrine 0.25%|"Phenylephrine 0.25%~Phenylephrine 0.25%: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213277|NCT02285634|BG002|Baseline|Lidocaine 1% Plus Epinephrine 1:100,000|"Lidocaine 1% plus epinephrine 1:100,000~Lidocaine 1% plus epinephrine 1:100,000: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213278|NCT02285634|BG003|Baseline|Bacteriostatic 0.9% NaCL|"Bacteriostatic 0.9% sodium chloride (NaCL)~Bacteriostatic 0.9% sodium chloride (NaCL): sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213279|NCT02285634|BG004|Baseline|Total|Total of all reporting groups
11213280|NCT02285634|FG000|Participant Flow|Oxymetazoline 0.05%|"Oxymetazoline 0.05%~Oxymetazoline 0.05%: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213281|NCT02285634|FG001|Participant Flow|Phenylephrine 0.25%|"Phenylephrine 0.25%~Phenylephrine 0.25%: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213282|NCT02285634|FG002|Participant Flow|Lidocaine 1% Plus Epinephrine 1:100,000|"Lidocaine 1% plus epinephrine 1:100,000~Lidocaine 1% plus epinephrine 1:100,000: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213283|NCT02285634|FG003|Participant Flow|Bacteriostatic 0.9% Sodium Chloride (NaCL)|"Bacteriostatic 0.9% NaCL~Bacteriostatic 0.9% sodium chloride (NaCL): sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213284|NCT02285634|OG000|Outcome|Oxymetazoline 0.05%|"Oxymetazoline 0.05%~Oxymetazoline 0.05%: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213285|NCT02285634|OG001|Outcome|Phenylephrine 0.25%|"Phenylephrine 0.25%~Phenylephrine 0.25%: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213286|NCT02285634|OG002|Outcome|Lidocaine 1% Plus Epinephrine 1:100,000|"Lidocaine 1% plus epinephrine 1:100,000~Lidocaine 1% plus epinephrine 1:100,000: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213287|NCT02285634|OG003|Outcome|Bacteriostatic 0.9% NaCL|"Bacteriostatic 0.9% sodium chloride (NaCL)~Bacteriostatic 0.9% sodium chloride (NaCL): sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213288|NCT02285634|OG003|Outcome|Bacteriostatic 0.9% NaCL|"Bacteriostatic 0.9% sodium chloride (NaCL)~Bacteriostatic 0.9% NaCL: sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% sodium chloride (NaCL) into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213289|NCT02285634|EG000|Reported Event|Oxymetazoline 0.05%|"Oxymetazoline 0.05%~Oxymetazoline 0.05%: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213290|NCT02285634|EG001|Reported Event|Phenylephrine 0.25%|"Phenylephrine 0.25%~Phenylephrine 0.25%: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213291|NCT02285634|EG002|Reported Event|Lidocaine 1% Plus Epinephrine 1:100,000|"Lidocaine 1% plus epinephrine 1:100,000~Lidocaine 1% plus epinephrine 1:100,000: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213292|NCT02285634|EG003|Reported Event|Bacteriostatic 0.9% NaCL|"Bacteriostatic 0.9% sodium chloride (NaCL)~Bacteriostatic 0.9% sodium chloride (NaCL): sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes."
11213293|NCT02285777|BG000|Baseline|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
11213294|NCT02285777|BG001|Baseline|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
11213295|NCT02285777|BG002|Baseline|Total|Total of all reporting groups
11213296|NCT02285777|FG000|Participant Flow|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
11213297|NCT02285777|FG001|Participant Flow|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
11213298|NCT02285777|OG000|Outcome|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
11213299|NCT02285777|OG001|Outcome|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
11213300|NCT02285777|EG000|Reported Event|MenABCWY Group|Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
11244980|NCT02515058|BG001|Baseline|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244981|NCT02515058|BG002|Baseline|Total|Total of all reporting groups
11244982|NCT02515058|FG000|Participant Flow|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244983|NCT02515058|FG001|Participant Flow|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244984|NCT02515058|OG000|Outcome|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244985|NCT02515058|OG001|Outcome|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244986|NCT02515058|EG000|Reported Event|Non-Freeze-Dried Bone Allograft (PUROS)|"Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)~PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244987|NCT02515058|EG001|Reported Event|Freeze-Dried Bone Allograft (FDBA)|"Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)~FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction"
11244988|NCT02515097|BG000|Baseline|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244989|NCT02515097|BG001|Baseline|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244990|NCT02515097|BG002|Baseline|Total|Total of all reporting groups
11244991|NCT02515097|FG000|Participant Flow|IDP-122 Lotion|Participants applied IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
11244992|NCT02515097|FG001|Participant Flow|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244993|NCT02515097|OG000|Outcome|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244994|NCT02515097|OG001|Outcome|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244995|NCT02515097|EG000|Reported Event|IDP-122 Lotion|Participants applied IDP-122 Lotion (HP 0.01%) topically once daily for 8 weeks.
11244996|NCT02515097|EG001|Reported Event|IDP-122 Vehicle Lotion|Participants applied IDP-122 Vehicle Lotion topically once daily for 8 weeks.
11244997|NCT02515253|BG000|Baseline|Prescription Group|"Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.~Bra prescription~Standard Care"
11244998|NCT02515253|BG001|Baseline|Standard Care Group|"Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.~Standard Care"
11244999|NCT02515253|BG002|Baseline|Total|Total of all reporting groups
11245000|NCT02515253|FG000|Participant Flow|Prescription Group|"Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.~Bra prescription~Standard Care"
11245001|NCT02515253|FG001|Participant Flow|Standard Care Group|"Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.~Standard Care"
11245002|NCT02515253|OG000|Outcome|Prescription Group|"Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.~Bra prescription~Standard Care"
11245003|NCT02515253|OG001|Outcome|Standard Care Group|"Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.~Standard Care"
11245004|NCT02515253|EG000|Reported Event|Prescription Group|"Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.~Bra prescription~Standard Care"
11245005|NCT02515253|EG001|Reported Event|Standard Care Group|"Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.~Standard Care"
11245006|NCT02515279|BG000|Baseline|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
11245007|NCT02515279|FG000|Participant Flow|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
11245008|NCT02515279|OG000|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
11245009|NCT02515279|EG000|Reported Event|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
11245010|NCT02515305|BG000|Baseline|Test Product|Clindamycin and Benzoyl Peroxide Gel (combination)
11245011|NCT02515305|BG001|Baseline|Reference Product|Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
11245012|NCT02515305|BG002|Baseline|Placebo Product|Placebo gel (combination)
11245013|NCT02515305|BG003|Baseline|Total|Total of all reporting groups
11245014|NCT02515305|FG000|Participant Flow|Test Product|Clindamycin and Benzoyl Peroxide Gel (combination)
11245015|NCT02515305|FG001|Participant Flow|Reference Product|Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
11245016|NCT02515305|FG002|Participant Flow|Placebo Product|Placebo gel (combination)
11245017|NCT02515305|OG000|Outcome|Test Product|Clindamycin and Benzoyl Peroxide Gel (combination)
11245018|NCT02515305|OG001|Outcome|Reference Product|Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
11245019|NCT02515305|OG002|Outcome|Placebo Product|Placebo gel (combination)
11245020|NCT02515305|EG000|Reported Event|Test Product|Clindamycin and Benzoyl Peroxide Gel (combination)
11245021|NCT02515305|EG001|Reported Event|Reference Product|Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
11245022|NCT02515305|EG002|Reported Event|Placebo Product|Placebo gel (combination)
11245023|NCT02515331|BG000|Baseline|LHW090 100 mg|LHW090 100 mg once daily for 28 days
11245024|NCT02515331|BG001|Baseline|LHW090 200 mg|LHW090 200 mg once daily for 28 days
11245025|NCT02515331|BG002|Baseline|Placebo|Matching placebo to LHW090 oral dose for 28 days
11245026|NCT02515331|BG003|Baseline|Total|Total of all reporting groups
11245027|NCT02515331|FG000|Participant Flow|LHW090 100 mg|LHW090 100 mg once daily for 28 days
11245028|NCT02515331|FG001|Participant Flow|LHW090 200 mg|LHW090 200 mg once daily for 28 days
11245029|NCT02515331|FG002|Participant Flow|Placebo|Matching placebo to LHW090 oral dose for 28 days
11245030|NCT02515331|OG000|Outcome|LHW090 100 mg|LHW090 100 mg once daily for 28 days
11245031|NCT02515331|OG001|Outcome|LHW090 200 mg|LHW090 200 mg once daily for 28 days
11245032|NCT02515331|OG002|Outcome|Placebo|Matching placebo to LHW090 oral dose for 28 days
11245033|NCT02515331|EG000|Reported Event|LHW090 100mg|LHW090 100 mg once daily for 28 days
11245034|NCT02515331|EG001|Reported Event|LHW090 200mg|LHW090 200 mg once daily for 28 days
11245035|NCT02515331|EG002|Reported Event|Placebo|Matching placebo to LHW090 oral dose for 28 days
11245036|NCT02515630|BG000|Baseline|Transfusion Independence Responders|Subjects who became transfusion independent by Week 24
11245037|NCT02515630|BG001|Baseline|Transfusion Independence Non-Responders|Subjects who did not become transfusion independent by Week 24
11245038|NCT02515630|BG002|Baseline|Total|Total of all reporting groups
11245039|NCT02515630|FG000|Participant Flow|Momelotinib (MMB)|Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
11245040|NCT02515630|OG000|Outcome|Total|All enrolled subjects
11245041|NCT02515630|OG000|Outcome|Transfusion Independence Responders|Subjects who became transfusion independent by Week 24
11245042|NCT02515630|OG001|Outcome|Transfusion Independence Non-Responders|Subjects who did not become transfusion independent by Week 24
11245043|NCT02515630|OG002|Outcome|Total|All enrolled subjects
11245044|NCT02515630|EG000|Reported Event|Momelotinib (MMB)|Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
11245045|NCT02515656|BG000|Baseline|POLYGYNAX®|"Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules~POLYGYNAX®"
11245046|NCT02515656|BG001|Baseline|Miconazole + Placebo|"Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules~GYNODAKTARIN®~Placebo"
11245047|NCT02515656|BG002|Baseline|Total|Total of all reporting groups
11245048|NCT02515656|FG000|Participant Flow|POLYGYNAX®|"Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules~POLYGYNAX®"
11245049|NCT02515656|FG001|Participant Flow|Miconazole + Placebo|"Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules~GYNODAKTARIN®~Placebo"
11245050|NCT02515656|OG000|Outcome|POLYGYNAX®|"Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules~POLYGYNAX®"
11245051|NCT02515656|OG001|Outcome|Miconazole + Placebo|"Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules~GYNODAKTARIN®~Placebo"
11245052|NCT02515656|EG000|Reported Event|POLYGYNAX®|"Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules~POLYGYNAX®"
10820091|NCT00053846|EG000|Reported Event|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
11213301|NCT02285777|EG001|Reported Event|MenACWY Group|Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
11213302|NCT02285855|BG000|Baseline|Metformin Arm|Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.
11213303|NCT02285855|BG001|Baseline|Placebo Arm|Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo.
11213304|NCT02285855|BG002|Baseline|Total|Total of all reporting groups
11213305|NCT02285855|FG000|Participant Flow|Metformin Arm|Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.
11213306|NCT02285855|FG001|Participant Flow|Placebo Arm|Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo.
11213307|NCT02285855|OG000|Outcome|Metformin Arm|Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.
11213308|NCT02285855|OG001|Outcome|Placebo Arm|Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo.
11213309|NCT02285855|EG000|Reported Event|Metformin Arm|Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.
11213310|NCT02285855|EG001|Reported Event|Placebo Arm|Patients randomized to placebo treatment will receive 3 weeks of daily placebo and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with placebo.
11213311|NCT02285907|BG000|Baseline|All Study Participants|All 21 participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size. In the macronutrient and fiber-matched comparisons, both lunch meals contained 24-g protein and 2-g fiber, differing only in the type of protein consumed (beef vs. soy). In the serving size-matched comparisons, the lunch meals contained 1 serving of beef (24-g protein/1-g fiber) or 1 serving of soy (14-g protein/5-g fiber). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue-stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2-7 days. However, there was 7-14 days in between each treatment.
11213312|NCT02285907|FG000|Participant Flow|All Study Participants|Twenty-four participants signed the consent but two withdrew prior to beginning testing day procedures. One participant was withdrawn due to protocol violations prior to beginning the fourth treatment. All 21 remaining participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size (Macronutrient and Fiber Matched BEEF, Macronutrient and Fiber Matched SOY, Serving Size Matched BEEF, and Serving Size Matched Soy). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue-stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2-7 days. However, there was 7-14 days in between each treatment.
11213313|NCT02285907|OG000|Outcome|Macronutrient and Fiber Matched Beef|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
11213314|NCT02285907|OG001|Outcome|Macronutrient and Fiber Matched Soy|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
11213315|NCT02285907|OG002|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
11213316|NCT02285907|OG003|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
11213317|NCT02285907|OG000|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
11213318|NCT02285907|OG001|Outcome|Serving Size Matched Soy|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
11213319|NCT02285907|OG001|Outcome|Serving Size Matched Beef|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
11213320|NCT02285907|EG000|Reported Event|Macronutrient and Fiber Matched BEEF|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
11245053|NCT02515656|EG001|Reported Event|Miconazole + Placebo|"Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules~GYNODAKTARIN®~Placebo"
11245054|NCT02515669|BG000|Baseline|Placebo|Placebo subcutaneous injections on specified days
11245055|NCT02515669|BG001|Baseline|Panel 1 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
11245056|NCT02515669|BG002|Baseline|Panel 2 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245057|NCT02515669|BG003|Baseline|Panel 3 and Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245058|NCT02515669|BG004|Baseline|Total|Total of all reporting groups
11245059|NCT02515669|FG000|Participant Flow|Placebo|Placebo subcutaneous injections on specified days
11245060|NCT02515669|FG001|Participant Flow|Panel 1 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
11245061|NCT02515669|FG002|Participant Flow|Panel 2 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245062|NCT02515669|FG003|Participant Flow|Panel 3 and Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245063|NCT02515669|OG000|Outcome|Placebo|Placebo subcutaneous injections on specified days
11245064|NCT02515669|OG001|Outcome|Panel 1 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
11245065|NCT02515669|OG002|Outcome|Panel 2 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245066|NCT02515669|OG003|Outcome|Panel 3 and Expansion RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245067|NCT02515669|OG000|Outcome|Panel 1 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
11245068|NCT02515669|OG001|Outcome|Panel 2 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245069|NCT02515669|OG002|Outcome|Panel 3 and Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245070|NCT02515669|OG000|Outcome|Panel 3 and Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245071|NCT02515669|OG001|Outcome|Panel 2 RO7239361 12.5mg|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245072|NCT02515669|OG002|Outcome|Panel 2 RO7239361 20mg|"RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL.~The dose was not administered at Days 1, 15, 22, 29 and 84."
11245073|NCT02515669|OG003|Outcome|Panel 3 RO7239361 35mg|RO7239361 subcutaneous injections on specified days. RO7239361 subcutaneous injections on specified days, The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245074|NCT02515669|OG004|Outcome|Expansion Panel RO7239361 35mg|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11286276|NCT02885506|EG004|Reported Event|Cohort 5|"500 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11245075|NCT02515669|OG005|Outcome|Expansion Panel RO7239361 50mg|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245076|NCT02515669|OG003|Outcome|Panel 3 and Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245077|NCT02515669|OG003|Outcome|Panel 3 RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245078|NCT02515669|OG004|Outcome|Expansion Panel RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245079|NCT02515669|OG003|Outcome|Panel 3RO7239361|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245080|NCT02515669|OG000|Outcome|Placebo, Then RO7239361|Placebo subcutaneous injections on specified days. At the end of the DB period these participants switched to treatment to treatment with RO7239361 at dose levels of either Panel 1, Panel 2 or Panel 3.
11245081|NCT02515669|OG001|Outcome|Panel 1 RO7239361 Whole Study|RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
11245082|NCT02515669|OG002|Outcome|Panel 2 RO7239361 Whole Study|RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
11245083|NCT02515669|OG003|Outcome|Panel 3 and Expansion Panel RO7239361 Whole Study|RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
11245084|NCT02515669|EG000|Reported Event|Placebo Double-Blind|Placebo subcutaneous injections on specified days during the double-blind period.
11245085|NCT02515669|EG001|Reported Event|Panel 1 RO7239361 Double-Blind|RO7239361 subcutaneous injections on specified days during the double-blind period.
11245086|NCT02515669|EG002|Reported Event|Panel 2 RO7239361 Double-Blind|RO7239361 subcutaneous injections on specified days during the double-blind period.
11245087|NCT02515669|EG003|Reported Event|Panel 3 and Expansion Panel RO7239361 Double-Blind|RO7239361 subcutaneous injections on specified days during the double-blind period.
11245088|NCT02515669|EG004|Reported Event|Panel 1 RO7239361 Open-Label|RO7239361 subcutaneous injections on specified days during the open-label period.
11245089|NCT02515669|EG005|Reported Event|Panel 2 RO7239361 Open-Label|RO7239361 subcutaneous injections on specified days during the open label period.
11245090|NCT02515669|EG006|Reported Event|Panel 3 and Expansion Panel RO7239361 Open-Label|RO7239361 subcutaneous injections on specified days during the open-label period.
11245091|NCT02515825|BG000|Baseline|AMBIENCE|"CADence System testing followed by coronary angiogram~CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram"
11245092|NCT02515825|BG001|Baseline|AMBIENCE Plus R&R Substudy|"CADence System testing for repeatability and reproducibility (4x by 2 operators) followed by coronary angiogram~CADence System: Obtain CADence data under normal conditions for comparison of results with those of coronary angiogram.~This part of the study includes patients who are a part of the AMBIENCE study."
11245093|NCT02515825|BG002|Baseline|Total|Total of all reporting groups
11245094|NCT02515825|FG000|Participant Flow|AMBIENCE Study|Participants in the initial AMBIENCE study period
11245095|NCT02515825|FG001|Participant Flow|AMBIENCE Plus R & R|Participants in the AMBIENCE plus Repeatability and Reproducibility portion of the study
11245096|NCT02515825|OG000|Outcome|Patient CADence Result|"CADence System testing followed by coronary angiogram~CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram"
11245097|NCT02515825|OG001|Outcome|Repeatability and Reproducibility|The purpose of the study is to collect performance information regarding the use of the CADence system under normal conditions of use. Includes a 31-subject sub-study to assess the repeatability and reproducibility of the CADence system
11245098|NCT02515825|OG000|Outcome|Adverse Events|There were zero reported adverse events.
11245099|NCT02515825|EG000|Reported Event|AMBIENCE|"CADence System testing followed by coronary angiogram~CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram"
11245100|NCT02515825|EG001|Reported Event|AMBIENCE Plus R&R Substudy|"CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram~CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram"
11245101|NCT02515890|BG000|Baseline|Dexmedetomidine Only|All subjects received saline (control) followed by dexmedetomidine infusion while performing memory task and receiving intermittent painful electric nerve stimulation.
11245102|NCT02515890|BG001|Baseline|Midazolam Only|All subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation.
11245103|NCT02515890|BG002|Baseline|Ketamine Only|All subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation.
11245104|NCT02515890|BG003|Baseline|Drug Order A|"All subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation on their first experimental visit.~For another experimental session, all subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation."
11245105|NCT02515890|BG004|Baseline|Drug Order B|"All subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation on their first experimental visit.~For another experimental session, all subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation."
11245106|NCT02515890|BG005|Baseline|Total|Total of all reporting groups
11245107|NCT02515890|FG000|Participant Flow|Dexmedetomidine|subjects received dexmedetomidine and saline (control)
11245108|NCT02515890|FG001|Participant Flow|Midazolam|subjects received midazolam and saline (control)
11245109|NCT02515890|FG002|Participant Flow|Ketamine|subjects received ketamine and saline (control)
11245110|NCT02515890|FG003|Participant Flow|Drug Order A|Subjects received saline (control) and midazolam during their first set of experimental sessions, and then received saline (control) and ketamine during a second set of sessions
11245111|NCT02515890|FG004|Participant Flow|Drug Order B|Subjects received saline (control) and ketamine during their first set of experimental sessions, and then received saline (control) and midazolam during a second set of sessions
11245112|NCT02515890|OG000|Outcome|Dexmedetomidine|Subjects assigned to receive dexmedetomidine as part of the study
11245113|NCT02515890|OG001|Outcome|Midazolam|Subjects assigned to receive midazolam as part of the study. Includes subjects from groups Midazolam Only, Drug Order A, and Drug Order B
11245114|NCT02515890|OG002|Outcome|Ketamine|Subjects assigned to receive ketamine as part of the study. Includes subjects from groups Ketamine Only, Drug Order A, and Drug Order B
11245115|NCT02515890|OG003|Outcome|Saline|All subjects subjects received saline as a control condition during their study visits. Includes subjects from Dexmedetomidine Only, Midazolam Only, Ketamine Only, Drug Order A, and Drug Order B.
11245116|NCT02515890|EG000|Reported Event|Dexmedetomidine Only|Dexmedetomidine: Subjects received this drug during a portion of the study
11245117|NCT02515890|EG001|Reported Event|Midazolam Only|Midazolam: Subjects received this drug during a portion of the study
11245118|NCT02515890|EG002|Reported Event|Ketamine Only|"Ketamine: Subjects received this drug during a portion of the study~All adverse events for Ketamine Only subjects were experienced during ketamine administration."
11245119|NCT02515890|EG003|Reported Event|Drug Order A|"Midazolam: Subjects received this drug during a portion of the study~Ketamine: Subjects received this drug during a portion of the study~These drugs were given on separate visits, occurring at least 14 days apart.~All adverse events for Drug Order A subjects were experienced during ketamine administration."
11245120|NCT02515890|EG004|Reported Event|Drug Order B|"Ketamine: Subjects received this drug during a portion of the study~Midazolam: Subjects received this drug during a portion of the study~These drugs were given on separate visits, occurring at least 14 days apart.~All adverse events for Drug Order B subjects were experienced during ketamine administration."
11245121|NCT02515942|BG000|Baseline|CLG561|CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
11245122|NCT02515942|BG001|Baseline|CLG561+LFG316|CLG561 5 mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
11245123|NCT02515942|BG002|Baseline|Sham Injection|One sham injection every 28 days for total of 12 sham injections
11245124|NCT02515942|BG003|Baseline|Total|Total of all reporting groups
11245125|NCT02515942|FG000|Participant Flow|CLG561|CLG561 10 mg, one intravitreal (IVT) injection every 28 days for a total of 12 injections
11245126|NCT02515942|FG001|Participant Flow|CLG561+LFG316|CLG561 5 mg +LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
11245127|NCT02515942|FG002|Participant Flow|Sham Injection|One sham injection every 28 days for total of 12 sham injections
11245128|NCT02515942|OG000|Outcome|CLG561|CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
11245129|NCT02515942|OG001|Outcome|CLG561+LFG316|CLG561 5 mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
11245130|NCT02515942|OG002|Outcome|Sham Injection|One sham injection every 28 days for total of 12 sham injections
11245131|NCT02515942|OG001|Outcome|CLG561+LFG316|CLG561 5 mg +LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
11245132|NCT02515942|OG000|Outcome|CLG561+LFG316|CLG561 5 mg +LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
11245133|NCT02515942|EG000|Reported Event|CLG561|All subjects exposed to CLG561 10 mg
11245134|NCT02515942|EG001|Reported Event|CLG561+LFG316|All subjects exposed to CLG561 5 mg + LFG316 5 mg
11245135|NCT02515942|EG002|Reported Event|Sham Injection|All subjects exposed to sham injection
11245136|NCT02515994|BG000|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11245137|NCT02515994|BG001|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11245138|NCT02515994|BG002|Baseline|Total|Total of all reporting groups
11245139|NCT02515994|FG000|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11245140|NCT02515994|FG001|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11245141|NCT02515994|OG000|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
11245142|NCT02515994|OG001|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
11245143|NCT02515994|EG000|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11245144|NCT02515994|EG001|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11245145|NCT02516046|BG000|Baseline|All Enrolled Cohort|All subjects consenting to flortaucipir PET and brain donation at autopsy
11245146|NCT02516046|FG000|Participant Flow|All Enrolled Cohort|End-of-life subjects consenting to brain donation at autopsy from the flortaucipir PET scan arm
11245147|NCT02516046|OG000|Outcome|Sensitivity of Flortaucipir vs Autopsy NFT Score B3|Subjects with a positive autopsy NFT score truth standard (NFT B3)
11245148|NCT02516046|OG001|Outcome|Specificity of Flortaucipir vs Autopsy NFT Score <B3|Subjects with a negative autopsy NFT score truth standard (NFT B2 or lower)
11245149|NCT02516046|OG000|Outcome|Sensitivity of Flortaucipir vs NIA-AA Autopsy Diagnosis|Subjects with a positive truth standard (High ADNC)
11245150|NCT02516046|OG001|Outcome|Specificity of Flortaucipir vs NIA-AA Autopsy Diagnosis|Subjects with a negative truth standard (No/Low/Intermediate ADNC)
11245151|NCT02516046|OG000|Outcome|Sensitivity of Flortaucipir vs Autopsy NFT Score B3|Subjects with a truth positive NFT Score (B3)
11245152|NCT02516046|OG001|Outcome|Specificity of Flortaucipir vs Autopsy NFT Score <B3|Subjects with a truth negative NFT Score (B2 or lower)
11245153|NCT02516046|OG000|Outcome|Sensitivity Majority Read NIA-AA Autopsy Diagnosis|Subjects with a truth positive NIA-AA autopsy diagnosis (High ADNC)
11245154|NCT02516046|OG001|Outcome|Specificity Majority Read NIA-AA Autopsy Diagnosis|Subjects with truth negative NIA-AA autopsy diagnosis (No/Low/Intermediate ADNC)
11245155|NCT02516046|OG000|Outcome|All Cases Read|All participants from the study for which a visual read flortaucipir PET result was obtained (n=105), regardless of whether the subject had a valid autopsy
11245156|NCT02516046|OG000|Outcome|Sensitivity of Flortaucipir vs Autopsy NFT Score B2-B3|Subjects with a positive autopsy NFT score truth standard (NFT B2 or B3)
11245157|NCT02516046|OG001|Outcome|Specificity of Flortaucipir vs Autopsy NFT Score B0-B1|Subjects with a negative autopsy NFT score truth standard (NFT B0 or B1)
11245158|NCT02516046|EG000|Reported Event|Safety Analysis Population|All enrolled subjects from the flortaucipir PET scan arm who received one dose of flortaucipir
11245159|NCT02516098|BG000|Baseline|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
11245160|NCT02516098|BG001|Baseline|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
11245161|NCT02516098|BG002|Baseline|Total|Total of all reporting groups
11245162|NCT02516098|FG000|Participant Flow|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
11245163|NCT02516098|FG001|Participant Flow|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
11245164|NCT02516098|OG000|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
11245165|NCT02516098|OG001|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
11245166|NCT02516098|EG000|Reported Event|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
11245167|NCT02516098|EG001|Reported Event|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
11245168|NCT02516150|BG000|Baseline|All Subjects|All subjects enrolled
11245169|NCT02516150|FG000|Participant Flow|All Subjects|All subjects enrolled
11245170|NCT02516150|OG000|Outcome|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.~Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%~Glucagon: injection of 50 micrograms of glucagon"
11286277|NCT02885506|EG005|Reported Event|Cohort 6|"750 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11245171|NCT02516150|OG001|Outcome|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.~Glucagon: injection of 50 micrograms of glucagon"
11245172|NCT02516150|EG000|Reported Event|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.~Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%~Glucagon: injection of 50 micrograms of glucagon"
11245173|NCT02516150|EG001|Reported Event|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.~Glucagon: injection of 50 micrograms of glucagon"
11245174|NCT02516163|BG000|Baseline|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
11245175|NCT02516163|FG000|Participant Flow|Shapematch Cutting Guides|The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study.
11245176|NCT02516163|OG000|Outcome|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
11245177|NCT02516163|EG000|Reported Event|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only.~Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study"
11245178|NCT02516202|BG000|Baseline|Vagifem|"One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.~Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.~A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.~Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."
11245179|NCT02516202|BG001|Baseline|Replens|"One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).~A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.~Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Placebo: Dispensed in visually identical bottle and tablet form."
11245180|NCT02516202|BG002|Baseline|Placebo|"One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.~The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.~Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).~Placebo: Dispensed in visually identical bottle and tablet form.~Placebo: Dispensed in visually identical tube and gel form."
11245181|NCT02516202|BG003|Baseline|Total|Total of all reporting groups
11245182|NCT02516202|FG000|Participant Flow|Vagifem|"One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.~Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.~A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.~Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."
11286278|NCT02885506|EG006|Reported Event|Cohort 7|"1000 mg P218 oral administration~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
10820092|NCT00053846|EG001|Reported Event|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
11213321|NCT02285907|EG001|Reported Event|Macronutrient and Fiber Matched SOY|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
11213322|NCT02285907|EG002|Reported Event|Serving Size Matched BEEF|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
11213323|NCT02285907|EG003|Reported Event|Serving Size Matched SOY|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
11213324|NCT02285920|BG000|Baseline|Placebo|"Participants will be treated with placebo for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213325|NCT02285920|BG001|Baseline|Spironolactone 12.5 mg|"Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213326|NCT02285920|BG002|Baseline|Spironolactone 25 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213327|NCT02285920|BG003|Baseline|Spironolactone 50 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213328|NCT02285920|BG004|Baseline|Total|Total of all reporting groups
11213329|NCT02285920|FG000|Participant Flow|Placebo|"Participants will be treated with placebo for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213330|NCT02285920|FG001|Participant Flow|Spironolactone 12.5 mg|"Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213331|NCT02285920|FG002|Participant Flow|Spironolactone 25 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213332|NCT02285920|FG003|Participant Flow|Spironolactone 50 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213333|NCT02285920|OG000|Outcome|Placebo|"Participants will be treated with placebo for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213334|NCT02285920|OG001|Outcome|Spironolactone 12.5 mg|"Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213335|NCT02285920|OG002|Outcome|Spironolactone 25 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213336|NCT02285920|OG003|Outcome|Spironolactone 50 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11245183|NCT02516202|FG001|Participant Flow|Replens|"One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).~A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.~Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Placebo: Dispensed in visually identical bottle and tablet form."
11245184|NCT02516202|FG002|Participant Flow|Placebo|"One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.~The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.~Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).~Placebo: Dispensed in visually identical bottle and tablet form.~Placebo: Dispensed in visually identical tube and gel form."
11245185|NCT02516202|OG000|Outcome|Vagifem|"One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.~Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.~A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.~Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."
11245186|NCT02516202|OG001|Outcome|Replens|"One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).~A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.~Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Placebo: Dispensed in visually identical bottle and tablet form."
11245187|NCT02516202|OG002|Outcome|Placebo|"One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.~The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.~Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).~Placebo: Dispensed in visually identical bottle and tablet form.~Placebo: Dispensed in visually identical tube and gel form."
11245188|NCT02516202|EG000|Reported Event|Vagifem|"One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.~Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.~A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.~Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."
11245189|NCT02516202|EG001|Reported Event|Replens|"One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).~A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.~Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.~Placebo: Dispensed in visually identical bottle and tablet form."
11245190|NCT02516202|EG002|Reported Event|Placebo|"One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.~The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.~Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).~Placebo: Dispensed in visually identical bottle and tablet form.~Placebo: Dispensed in visually identical tube and gel form."
11245191|NCT02516306|BG000|Baseline|EV06 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
11245192|NCT02516306|BG001|Baseline|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
11245193|NCT02516306|BG002|Baseline|Total|Total of all reporting groups
11245194|NCT02516306|FG000|Participant Flow|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.
11245195|NCT02516306|FG001|Participant Flow|Placebo|Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes.
11245196|NCT02516306|OG000|Outcome|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
11245197|NCT02516306|OG001|Outcome|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
11245198|NCT02516306|EG000|Reported Event|EVO6|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
11245199|NCT02516306|EG001|Reported Event|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
11245200|NCT02516332|BG000|Baseline|Supervised Aerobic Exercise|"Patients will exercise three times per week, under medical supervision, at a level of 70-85% of their VO2peak as determined at the time of their baseline exercise stress test. Patients' exercise will consist of 10 minutes of gradual warm-up exercises followed by 35 minutes of continuous walking, biking, or jogging, and 5 minutes of cool down exercises for a total a 50 minutes per session. Patients will be instructed to monitor their radial pulses and will be checked at least three times per session to ensure that they are within their prescribed exercise training ranges.~Supervised Aerobic Exercise"
11245201|NCT02516332|BG001|Baseline|Lexapro|"Treatment in the medication will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service. The investigators will use the SSRI escitalopram (Lexapro), which has received FDA approval for the treatment of anxiety, in 5 mg capsules. Medication will be dispensed as capsules of escitalopram in individually coded bottles. Medication adherence will be assessed using pill count at each study visit. Patients will visit face-to-face with a study psychiatrist at week 0 (baseline), week 1, week 2, week 4, week 8, and week 12 with phone encounters at weeks 3 and 6. The psychiatrist will make all medication adjustments based primarily upon Spielberger Anxiety Scores. Depending on symptoms, daily escitalopram doses will be titrated to 10 mg after week 2 and to 15 mg or placebo equivalent at week 3 if patients show no change or only minimal improvement.~Lexapro"
11245202|NCT02516332|BG002|Baseline|Placebo|"Treatment in the medication and placebo pill arms will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service, who have extensive experience in clinical trials. Medication will be taken once daily in the morning but can be switched to once daily in the evening if deemed necessary. Placebo medication administration will follow the same protocol as outlined for Lexapro.~Placebo"
11245203|NCT02516332|BG003|Baseline|Total|Total of all reporting groups
11245204|NCT02516332|FG000|Participant Flow|Supervised Aerobic Exercise|"Patients will exercise three times per week, under medical supervision, at a level of 70-85% of their VO2peak as determined at the time of their baseline exercise stress test. Patients' exercise will consist of 10 minutes of gradual warm-up exercises followed by 35 minutes of continuous walking, biking, or jogging, and 5 minutes of cool down exercises for a total a 50 minutes per session. Patients will be instructed to monitor their radial pulses and will be checked at least three times per session to ensure that they are within their prescribed exercise training ranges.~Supervised Aerobic Exercise"
11245205|NCT02516332|FG001|Participant Flow|Lexapro|"Treatment in the medication will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service. The investigators will use the SSRI escitalopram (Lexapro), which has received FDA approval for the treatment of anxiety, in 5 mg capsules. Medication will be dispensed as capsules of escitalopram in individually coded bottles. Medication adherence will be assessed using pill count at each study visit. Patients will visit face-to-face with a study psychiatrist at week 0 (baseline), week 1, week 2, week 4, week 8, and week 12 with phone encounters at weeks 3 and 6. The psychiatrist will make all medication adjustments based primarily upon Spielberger Anxiety Scores. Depending on symptoms, daily escitalopram doses will be titrated to 10 mg after week 2 and to 15 mg or placebo equivalent at week 3 if patients show no change or only minimal improvement.~Lexapro"
11245206|NCT02516332|FG002|Participant Flow|Placebo|"Treatment in the medication and placebo pill arms will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service, who have extensive experience in clinical trials. Medication will be taken once daily in the morning but can be switched to once daily in the evening if deemed necessary. Placebo medication administration will follow the same protocol as outlined for Lexapro.~Placebo"
11245207|NCT02516332|OG000|Outcome|Supervised Aerobic Exercise|"Patients will exercise three times per week, under medical supervision, at a level of 70-85% of their VO2peak as determined at the time of their baseline exercise stress test. Patients' exercise will consist of 10 minutes of gradual warm-up exercises followed by 35 minutes of continuous walking, biking, or jogging, and 5 minutes of cool down exercises for a total a 50 minutes per session. Patients will be instructed to monitor their radial pulses and will be checked at least three times per session to ensure that they are within their prescribed exercise training ranges.~Supervised Aerobic Exercise"
11245208|NCT02516332|OG001|Outcome|Lexapro|"Treatment in the medication will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service. The investigators will use the SSRI escitalopram (Lexapro), which has received FDA approval for the treatment of anxiety, in 5 mg capsules. Medication will be dispensed as capsules of escitalopram in individually coded bottles. Medication adherence will be assessed using pill count at each study visit. Patients will visit face-to-face with a study psychiatrist at week 0 (baseline), week 1, week 2, week 4, week 8, and week 12 with phone encounters at weeks 3 and 6. The psychiatrist will make all medication adjustments based primarily upon Spielberger Anxiety Scores. Depending on symptoms, daily escitalopram doses will be titrated to 10 mg after week 2 and to 15 mg or placebo equivalent at week 3 if patients show no change or only minimal improvement.~Lexapro"
11286279|NCT02885506|EG007|Reported Event|Pooled Placebo|"Placebo capsule oral administration~Oral administration of P218 matching placebo: The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug."
11245209|NCT02516332|OG002|Outcome|Placebo|"Treatment in the medication and placebo pill arms will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service, who have extensive experience in clinical trials. Medication will be taken once daily in the morning but can be switched to once daily in the evening if deemed necessary. Placebo medication administration will follow the same protocol as outlined for Lexapro.~Placebo"
11245210|NCT02516332|EG000|Reported Event|Supervised Aerobic Exercise|"Patients will exercise three times per week, under medical supervision, at a level of 70-85% of their VO2peak as determined at the time of their baseline exercise stress test. Patients' exercise will consist of 10 minutes of gradual warm-up exercises followed by 35 minutes of continuous walking, biking, or jogging, and 5 minutes of cool down exercises for a total a 50 minutes per session. Patients will be instructed to monitor their radial pulses and will be checked at least three times per session to ensure that they are within their prescribed exercise training ranges.~Supervised Aerboic Exercise"
11245211|NCT02516332|EG001|Reported Event|Lexapro|"Treatment in the medication will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service. The investigators will use the SSRI escitalopram (Lexapro), which has received FDA approval for the treatment of anxiety, in 5 mg capsules. Medication will be dispensed as capsules of escitalopram in individually coded bottles. Medication adherence will be assessed using pill count at each study visit. Patients will visit face-to-face with a study psychiatrist at week 0 (baseline), week 1, week 2, week 4, week 8, and week 12 with phone encounters at weeks 3 and 6. The psychiatrist will make all medication adjustments based primarily upon Spielberger Anxiety Scores. Depending on symptoms, daily escitalopram doses will be titrated to 10 mg after week 2 and to 15 mg or placebo equivalent at week 3 if patients show no change or only minimal improvement.~Lexapro"
11245212|NCT02516332|EG002|Reported Event|Placebo|"Treatment in the medication and placebo pill arms will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service, who have extensive experience in clinical trials. Medication will be taken once daily in the morning but can be switched to once daily in the evening if deemed necessary. Placebo medication administration will follow the same protocol as outlined for Lexapro.~Placebo"
11245213|NCT02516410|BG000|Baseline|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
11245214|NCT02516410|BG001|Baseline|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
11245215|NCT02516410|BG002|Baseline|Total|Total of all reporting groups
11245216|NCT02516410|FG000|Participant Flow|Placebo|Placebo matched to VX-661 plus Ivacaftor (IVA, VX-770) fixed dose combination (FDC) tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
11245217|NCT02516410|FG001|Participant Flow|VX-661/IVA|VX-661 100 milligram (mg) plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
11245218|NCT02516410|OG000|Outcome|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
11245219|NCT02516410|OG001|Outcome|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
11245220|NCT02516410|OG000|Outcome|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
11245221|NCT02516410|EG000|Reported Event|Placebo|Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
11245222|NCT02516410|EG001|Reported Event|VX-661/IVA|VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
11245223|NCT02516579|BG000|Baseline|Patients With Sickle Cell Disease Treated With Siklos®|The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
11245224|NCT02516579|FG000|Participant Flow|Patients With Sickle Cell Disease Treated With Siklos®|The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
11245225|NCT02516579|OG000|Outcome|Patients With Sickle Cell Disease Treated With Siklos®|The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
11245226|NCT02516579|EG000|Reported Event|Patients With Sickle Cell Disease Treated With Siklos®|The follow-up of the patients was strictly observational and fitted within their usual clinical monitoring without any controlled treatment, specific exam or modification of their follow-up, in compliance with the Summary of Product Characteristics of the product.
11245227|NCT02516592|BG000|Baseline|QVA149 110/50 Micrograms|QVA149 110/50 micrograms o.d. Capsules for inhalation
11245228|NCT02516592|BG001|Baseline|Salmeterol/Fluticasone 50/500 Micrograms|salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
11245229|NCT02516592|BG002|Baseline|Total|Total of all reporting groups
11245230|NCT02516592|FG000|Participant Flow|QVA149 110/50 Micrograms|QVA149 110/50 micrograms o.d. Capsules for inhalation
11245231|NCT02516592|FG001|Participant Flow|Salmeterol/Fluticasone 50/500 Micrograms|salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
11245232|NCT02516592|OG000|Outcome|QVA149 110/50 Micrograms|QVA149 110/50 micrograms o.d. Capsules for inhalation
11245233|NCT02516592|OG001|Outcome|Salmeterol/Fluticasone 50/500 Micrograms|salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
11245234|NCT02516592|EG000|Reported Event|QVA149|QVA149 110/50 micrograms o.d. Capsules for inhalation
10820093|NCT00053898|BG000|Baseline|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~Drug: tamoxifen citrate~20 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
10820094|NCT00053898|BG001|Baseline|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~Drug: anastrozole~1 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
10820095|NCT00053898|BG002|Baseline|Total|Total of all reporting groups
10820096|NCT00053898|FG000|Participant Flow|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
11245235|NCT02516592|EG001|Reported Event|Salm/Flut|salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
10820097|NCT00053898|FG001|Participant Flow|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
10820098|NCT00053898|OG000|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
10820099|NCT00053898|OG001|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
10820100|NCT00053898|EG000|Reported Event|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~Drug: tamoxifen citrate~20 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
10820101|NCT00053898|EG001|Reported Event|Group 2: Anastrazole + Tamoxifen Placebo|"anastrozole, 1 mg/day and a tamoxifen look-alike placebo for 5 years~Drug: anastrozole~1 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
10820102|NCT00053989|BG000|Baseline|All Patients|"All patients enrolled on study Patients received cyclophosphamide 50 mg/kg on days -5 and -4, and fludarabine 25 mg/m2 on days -5, -4, -3, -2, -1.~Hematopoietic cells from peripheral blood or marrow were infused on day 0. Patients who received hematopoietic cells from cord blood additionally received ATG 30 mg/kg on days -3, -2, -1.~Fanconi anemia patients received cyclophosphamide 7.5 mg/kg on days -6, -5, -4, -3, fludarabine 25 mg/m2 on days -6, -5, -4, -3, -2 and ATG 30 mg/kg on days -3, -2, -1 and hematopoietic cells infused on day 0."
10820103|NCT00053989|FG000|Participant Flow|All Patients|"All patients enrolled on study Patients received cyclophosphamide 50 mg/kg on days -5 and -4, and fludarabine 25 mg/m2 on days -5, -4, -3, -2, -1.~Hematopoietic cells from peripheral blood or marrow were infused on day 0. Patients who received hematopoietic cells from cord blood additionally received ATG 30 mg/kg on days -3, -2, -1.~Fanconi anemia patients received cyclophosphamide 7.5 mg/kg on days -6, -5, -4, -3, fludarabine 25 mg/m2 on days -6, -5, -4, -3, -2 and ATG 30 mg/kg on days -3, -2, -1 and hematopoietic cells infused on day 0."
10820104|NCT00053989|OG000|Outcome|All Patients|All patients enrolled on study
10820105|NCT00053989|EG000|Reported Event|All Patients|All patients enrolled on study
10820106|NCT00054028|BG000|Baseline|Suramin and Paclitaxel (Phase I)|Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
10820107|NCT00054028|BG001|Baseline|Suramin and Paclitaxel (Phase II)|Patients receive paclitaxel in combination with the target dose of suramin.
10820108|NCT00054028|BG002|Baseline|Total|Total of all reporting groups
10820109|NCT00054028|FG000|Participant Flow|Treatment (Suramin and Paclitaxel)|"PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.~PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above."
10820110|NCT00054028|OG000|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
10820111|NCT00054028|OG000|Outcome|Treatment (Suramin and Paclitaxel)|PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
10820112|NCT00054028|EG000|Reported Event|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
10820113|NCT00054132|BG000|Baseline|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10820114|NCT00054132|FG000|Participant Flow|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10820115|NCT00054132|OG000|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10820116|NCT00054132|OG000|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|"Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11245236|NCT02516605|BG000|Baseline|LJN452 - 0.03 mg qd|Tropifexor 0.03 mg daily for 28 days
11245237|NCT02516605|BG001|Baseline|LJN452 - 0.06 mg qd|Tropifexor 0.06 mg daily for 28 days
11245238|NCT02516605|BG002|Baseline|LJN452 - 0.09 mg qd|Tropifexor 0.09 mg daily for 28 days
11245239|NCT02516605|BG003|Baseline|LJN452 - 0.15 mg qd|Tropifexor 0.15 mg daily for 28 days
11213337|NCT02285920|EG000|Reported Event|Placebo|"Participants will be treated with placebo for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213338|NCT02285920|EG001|Reported Event|Spironolactone 12.5 mg|"Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213339|NCT02285920|EG002|Reported Event|Spironolactone 25 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213340|NCT02285920|EG003|Reported Event|Spironolactone 50 mg|"Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.~Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks."
11213341|NCT02285998|BG000|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
11213342|NCT02285998|BG001|Baseline|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
11213343|NCT02285998|BG002|Baseline|Total|Total of all reporting groups
11213344|NCT02285998|FG000|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
11213345|NCT02285998|FG001|Participant Flow|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
11213346|NCT02285998|OG000|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
11213347|NCT02285998|OG001|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
11213348|NCT02285998|EG000|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
11213349|NCT02285998|EG001|Reported Event|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
11213350|NCT02286102|BG000|Baseline|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213351|NCT02286102|BG001|Baseline|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213352|NCT02286102|BG002|Baseline|Total|Total of all reporting groups
11213353|NCT02286102|FG000|Participant Flow|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213354|NCT02286102|FG001|Participant Flow|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213355|NCT02286102|OG000|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213356|NCT02286102|OG001|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
11245240|NCT02516605|BG004|Baseline|Placebo qd|Tropifexor placebo daily for 28 days
11245241|NCT02516605|BG005|Baseline|Total|Total of all reporting groups
11245242|NCT02516605|FG000|Participant Flow|LJN452 - 0.03 mg qd|Tropifexor 0.03 mg daily for 28 days
11245243|NCT02516605|FG001|Participant Flow|LJN452 - 0.06 mg qd|Tropifexor 0.06 mg daily for 28 days
11245244|NCT02516605|FG002|Participant Flow|LJN452 - 0.09 mg qd|Tropifexor 0.09 mg daily for 28 days
11245245|NCT02516605|FG003|Participant Flow|LJN452 - 0.15 mg qd|Tropifexor 0.15 mg daily for 28 days
11245246|NCT02516605|FG004|Participant Flow|Placebo qd|Tropifexor placebo daily for 28 days
11245247|NCT02516605|OG000|Outcome|LJN452 - 0.03 mg qd|Tropifexor 0.03 mg daily for 28 days.
11245248|NCT02516605|OG001|Outcome|LJN452 - 0.06 mg qd|Tropifexor 0.06 mg daily for 28 days
11245249|NCT02516605|OG002|Outcome|LJN452 - 0.09 mg qd|Tropifexor 0.09 mg daily for 28 days
11245250|NCT02516605|OG003|Outcome|LJN452 - 0.15 mg qd|Tropifexor 0.15 mg daily for 28 days
11245251|NCT02516605|OG004|Outcome|Pooled Placebo|Placebo data from all cohorts were pooled.
11245252|NCT02516605|OG004|Outcome|Placebo qd|Tropifexor placebo daily for 28 days
11245253|NCT02516605|OG001|Outcome|LJN452 - 0.06 mg qd|Tropifexor 0.06 mg daily for 28 days.
11245254|NCT02516605|OG002|Outcome|LJN452 - 0.09 mg qd|Tropifexor 0.09 mg daily for 28 days.
11245255|NCT02516605|OG003|Outcome|LJN452 - 0.15 mg qd|Tropifexor 0.15 mg daily for 28 days.
11245256|NCT02516605|EG000|Reported Event|LJN452 - 0.03 mg qd|Tropifexor 0.03 mg daily for 28 days
11245257|NCT02516605|EG001|Reported Event|LJN452 - 0.06 mg qd|Tropifexor 0.06 mg daily for 28 days
11245258|NCT02516605|EG002|Reported Event|LJN452 - 0.09 mg qd|Tropifexor 0.09 mg daily for 28 days
11245259|NCT02516605|EG003|Reported Event|LJN452 - 0.15 mg qd|Tropifexor 0.15 mg daily for 28 days
11245260|NCT02516605|EG004|Reported Event|Placebo qd|Tropifexor placebo daily for 28 days
11245261|NCT02516982|BG000|Baseline|Screening - Scrolling Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.~All questions were presented on a single screen. This means that participants had to scroll vertically to answer all the questions."
11245262|NCT02516982|BG001|Baseline|Screening - Paging Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.~Only one question was displayed on the screen at any given time. This means that participants had to navigate through multiple pages in order to answer all the questions."
11245263|NCT02516982|BG002|Baseline|Retrospective Plus Momentary Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants were required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions.
11245264|NCT02516982|BG003|Baseline|Retrospective Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days consisted of a single administration of the Edinburgh Postnatal Depression Scale.
11245265|NCT02516982|BG004|Baseline|Total|Total of all reporting groups
11245266|NCT02516982|FG000|Participant Flow|Screening - Scrolling Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the Edinburgh Postnatal Depression Scale.~All questions were presented on a single screen. This means that participants had to scroll vertically to answer all the questions."
11245267|NCT02516982|FG001|Participant Flow|Screening - Paging Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the Edinburgh Postnatal Depression Scale.~Only one question was displayed on the screen at any given time. This means that participants had to navigate through multiple pages in order to answer all the questions."
11245268|NCT02516982|FG002|Participant Flow|Retrospective Plus Momentary Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were be asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants were required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions.
11245269|NCT02516982|FG003|Participant Flow|Retrospective Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days consisted of a single administration of the Edinburgh Postnatal Depression Scale.
11245270|NCT02516982|OG000|Outcome|Screening - Scrolling Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.~All questions were presented on a single screen. This means that participants had to scroll vertically to answer all the questions."
11286280|NCT02885506|EG008|Reported Event|Fasted Cohort|"A single oral dose of 250 mg of P218 under fasted conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11245271|NCT02516982|OG001|Outcome|Screening - Paging Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.~Only one question was displayed on the screen at any given time. This means that participants had to navigate through multiple pages in order to answer all the questions."
11245272|NCT02516982|OG000|Outcome|Retrospective Plus Momentary Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants were required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions.
11245273|NCT02516982|OG001|Outcome|Retrospective Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days consisted of a single administration of the Edinburgh Postnatal Depression Scale.
11245274|NCT02516982|EG000|Reported Event|Screening - Scrolling Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the Edinburgh Postnatal Depression Scale.~All questions were presented on a single screen. This means that participants had to scroll vertically to answer all the questions."
11245275|NCT02516982|EG001|Reported Event|Screening - Paging Layout|"Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the Edinburgh Postnatal Depression Scale.~Only one question was displayed on the screen at any given time. This means that participants had to navigate through multiple pages in order to answer all the questions."
11245276|NCT02516982|EG002|Reported Event|Retrospective Plus Momentary Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were be asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants were required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions.
11245277|NCT02516982|EG003|Reported Event|Retrospective Assessment|Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days consisted of a single administration of the Edinburgh Postnatal Depression Scale.
11245278|NCT02517021|BG000|Baseline|Pro-netupitant/Palonosetron Plus Dexamethasone|"Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Pro-netupitant/Palonosetron~Dexamethasone"
11245279|NCT02517021|BG001|Baseline|Netupitant/Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant/Palonosetron~Dexamethasone"
11245280|NCT02517021|BG002|Baseline|Total|Total of all reporting groups
11245281|NCT02517021|FG000|Participant Flow|Pro-netupitant/Palonosetron Plus Dexamethasone|"Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Pro-netupitant/Palonosetron~Dexamethasone"
11245282|NCT02517021|FG001|Participant Flow|Netupitant/Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant/Palonosetron~Dexamethasone"
11245283|NCT02517021|OG000|Outcome|Pro-netupitant/Palonosetron Plus Dexamethasone|"Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Pro-netupitant/Palonosetron~Dexamethasone"
11245284|NCT02517021|OG001|Outcome|Netupitant/Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant/Palonosetron~Dexamethasone"
11245285|NCT02517021|EG000|Reported Event|Pro-netupitant/Palonosetron Plus Dexamethasone|"Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Pro-netupitant/Palonosetron~Dexamethasone"
11245286|NCT02517021|EG001|Reported Event|Netupitant/Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant/Palonosetron~Dexamethasone"
11245287|NCT02517047|BG000|Baseline|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
11245288|NCT02517047|FG000|Participant Flow|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
11245289|NCT02517047|OG000|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
11286281|NCT02885506|EG009|Reported Event|Fed Cohort|"A single oral dose of 250 mg of P218 under fed conditions.~Oral administration of P218 capsules: The number of capsules is determined by the dose level of the cohort."
11245290|NCT02517047|OG000|Outcome|CareTRx Device|"All eligible participants will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app.~All data in the table represent values collected during the study and no placeholder values were used."
11245291|NCT02517047|EG000|Reported Event|CareTRx Device|"Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.~CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma."
11245292|NCT02517268|BG000|Baseline|Standard 7-Day Pathway|"Patients follow the standard 7-day pathway following pancreaticoduodenectomy~Pancreaticoduodenectomy"
11245293|NCT02517268|BG001|Baseline|Accelerated 5-Day Pathway|"Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.~Pancreaticoduodenectomy"
11245294|NCT02517268|BG002|Baseline|Total|Total of all reporting groups
11245295|NCT02517268|FG000|Participant Flow|Standard 7-Day Pathway|"Patients follow the standard 7-day pathway following pancreaticoduodenectomy~Pancreaticoduodenectomy"
11245296|NCT02517268|FG001|Participant Flow|Accelerated 5-Day Pathway|"Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.~Pancreaticoduodenectomy"
11245297|NCT02517268|OG000|Outcome|Standard 7-Day Pathway|"Patients follow the standard 7-day pathway following pancreaticoduodenectomy~Pancreaticoduodenectomy"
11245298|NCT02517268|OG001|Outcome|Accelerated 5-Day Pathway|"Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.~Pancreaticoduodenectomy"
11245299|NCT02517268|EG000|Reported Event|Standard 7-Day Pathway|"Patients follow the standard 7-day pathway following pancreaticoduodenectomy~Pancreaticoduodenectomy"
11245300|NCT02517268|EG001|Reported Event|Accelerated 5-Day Pathway|"Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.~Pancreaticoduodenectomy"
11245301|NCT02517463|BG000|Baseline|Pre-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245302|NCT02517463|BG001|Baseline|Post-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245303|NCT02517463|BG002|Baseline|Total|Total of all reporting groups
11245304|NCT02517463|FG000|Participant Flow|Pre-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245305|NCT02517463|FG001|Participant Flow|Post-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245306|NCT02517463|OG000|Outcome|Pre-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245307|NCT02517463|OG001|Outcome|Post-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245308|NCT02517463|EG000|Reported Event|Pre-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245309|NCT02517463|EG001|Reported Event|Post-ovulatory|"Ulipristal acetate 30 mg single oral dose~Ulipristal acetate: This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator."
11245310|NCT02517515|BG000|Baseline|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245311|NCT02517515|BG001|Baseline|Double-blind Placebo Followed by Open-label 3-DAA|Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245312|NCT02517515|BG002|Baseline|Total|Total of all reporting groups
11245313|NCT02517515|FG000|Participant Flow|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245314|NCT02517515|FG001|Participant Flow|Double-blind Placebo Followed by Open-label 3-DAA|Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245315|NCT02517515|OG000|Outcome|Double-blind 3-DAA (Treatment-Naïve)|Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245316|NCT02517515|OG001|Outcome|Double-blind 3-DAA (Treatment-Experienced)|Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245317|NCT02517515|EG000|Reported Event|Double-blind 3-DAA|Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245318|NCT02517515|EG001|Reported Event|Double-blind Placebo|Double-blind placebo for 12 weeks.
11245319|NCT02517515|EG002|Reported Event|Open-label 3-DAA|Open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
11245320|NCT02517528|BG000|Baseline|ABT-450/r/ABT-267 + ABT-333 + Ribavirin|ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
11245321|NCT02517528|FG000|Participant Flow|ABT-450/r/ABT-267 + ABT-333 + Ribavirin|ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based ribavirin (RBV) divided twice daily for 12 weeks
11245322|NCT02517528|OG000|Outcome|ABT-450/r/ABT-267 + ABT-333 + Ribavirin|ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
11245323|NCT02517528|EG000|Reported Event|ABT-450/r/ABT-267 + ABT-333 + Ribavirin|ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
11245324|NCT02517541|BG000|Baseline|Test Period|"The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft)~SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast"
11245325|NCT02517541|FG000|Participant Flow|Test Period|"The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft)~SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast"
11245326|NCT02517541|OG000|Outcome|Own Product|The mean leakage area measured on the subjects own baseplate
11245327|NCT02517541|OG001|Outcome|SenSura Mio Convex Soft|The mean leakage area measured on SenSura Mio Convex Soft baseplates
11245328|NCT02517541|EG000|Reported Event|Own Product|The mean leakage area measured on the subjects own baseplate
11245329|NCT02517541|EG001|Reported Event|SenSura Mio Convex Soft|The mean leakage area measured on SenSura Mio Convex Soft baseplates
11245330|NCT02517567|BG000|Baseline|Overall|Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion
11245331|NCT02517567|FG000|Participant Flow|Sequence 1|DAILIES TOTAL1 (DT1)/TruEye/clariti/No Lens
11245332|NCT02517567|FG001|Participant Flow|Sequence 2|TruEye/No Lens/DT1/clariti
11245333|NCT02517567|FG002|Participant Flow|Sequence 3|clariti/DT1/No Lens/TruEye
11245334|NCT02517567|FG003|Participant Flow|Sequence 4|No Lens/clariti/TruEye/DT1
11245335|NCT02517567|OG000|Outcome|Lens|Delefilcon A contact lenses, narafilcon A contact lenses, and somofilcon A contact lenses worn bilaterally in cross-over fashion as randomized. Each product worn for one day, 8 hours minimum.
11245336|NCT02517567|OG001|Outcome|No Lens|One 8-hour day of no lens wear as part of the crossover sequence
11245337|NCT02517567|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to exposure to the investigational product (including the 'No Lens wear' treatment)
11245338|NCT02517567|EG001|Reported Event|DAILIES TOTAL1|All subjects exposed to DT1 contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
11245339|NCT02517567|EG002|Reported Event|TruEye|All subjects exposed to TruEye contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
11245340|NCT02517567|EG003|Reported Event|Clariti|All subjects exposed to clariti contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized
11245341|NCT02517567|EG004|Reported Event|No Lens|"All subjects exposed to No lens wear for 8 hours during Period 1, 2, 3, or 4 as randomized"
11245342|NCT02517580|BG000|Baseline|Vitamin K2 (MK7)|Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
11245343|NCT02517580|FG000|Participant Flow|Vitamin K2 (MK7)|Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
11245344|NCT02517580|OG000|Outcome|Vitamin K2 (MK7)|"Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks~Vitamin K2 (MK7)"
11245345|NCT02517580|EG000|Reported Event|Vitamin K2 (MK7)|"Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks~Vitamin K2 (MK7)"
11245346|NCT02517658|BG000|Baseline|Standard Discharge Teaching|"Parents will receive standard discharge teaching from the nurse prior to discharge.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245347|NCT02517658|BG001|Baseline|Video w/ Post Exam Immediately After Video|"Parents will watch the video and then take the post test immediately after watching the video.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions."
11245348|NCT02517658|BG002|Baseline|Video w/ Post Exam After Discharge Teaching|"Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245349|NCT02517658|BG003|Baseline|Total|Total of all reporting groups
11245350|NCT02517658|FG000|Participant Flow|Standard Discharge Teaching|"Parents will receive standard discharge teaching from the nurse prior to discharge.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245351|NCT02517658|FG001|Participant Flow|Video w/ Post Exam Immediately After Video|"Parents will watch the video and then take the post test immediately after watching the video.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions."
11245352|NCT02517658|FG002|Participant Flow|Video w/ Post Exam After Discharge Teaching|"Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245353|NCT02517658|OG000|Outcome|Standard Discharge Teaching|"Parents will receive standard discharge teaching from the nurse prior to discharge.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245354|NCT02517658|OG001|Outcome|Video w/ Post Exam Immediately After Video|"Parents will watch the video and then take the post test immediately after watching the video.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions."
11245355|NCT02517658|OG002|Outcome|Video w/ Post Exam After Discharge Teaching|"Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245356|NCT02517658|EG000|Reported Event|Standard Discharge Teaching|"Parents will receive standard discharge teaching from the nurse prior to discharge.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245357|NCT02517658|EG001|Reported Event|Video w/ Post Exam Immediately After Video|"Parents will watch the video and then take the post test immediately after watching the video.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions."
11245358|NCT02517658|EG002|Reported Event|Video w/ Post Exam After Discharge Teaching|"Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.~Video: Watching a YouTube video containing post tonsillectomy discharge instructions.~Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge."
11245359|NCT02517866|BG000|Baseline|Azilsartan Medoxomil|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6.
11245360|NCT02517866|FG000|Participant Flow|Azilsartan Medoxomil (Switched)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
11245361|NCT02517866|FG001|Participant Flow|Azilsartan Medoxomil (Add-On)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
11245362|NCT02517866|FG002|Participant Flow|Azilsartan Medoxomil (Treatment-Naïve)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
11245363|NCT02517866|OG000|Outcome|Azilsartan Medoxomil (Switched)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
11245364|NCT02517866|OG001|Outcome|Azilsartan Medoxomil (Add-On)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
11245365|NCT02517866|OG000|Outcome|Azilsartan Medoxomil (Treatment-Naïve)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
11245366|NCT02517866|OG000|Outcome|Azilsartan Medoxomil|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6.
11245367|NCT02517866|OG002|Outcome|Azilsartan Medoxomil (Treatment-Naïve)|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
11245368|NCT02517866|EG000|Reported Event|Before Week 6 Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 6 weeks.
11245369|NCT02517866|EG001|Reported Event|After Week 6 Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for Week 6 up to Week 12.
11245370|NCT02517866|EG002|Reported Event|After Week 6 Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once, daily, for Week 6 up to Week 12.
11245371|NCT02517905|BG000|Baseline|EXPAREL 133 mg|"10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Bupivacaine liposome: Local administration"
11245372|NCT02517905|BG001|Baseline|Placebo|"10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Placebo: Local administration"
11245373|NCT02517905|BG002|Baseline|Total|Total of all reporting groups
11245374|NCT02517905|FG000|Participant Flow|EXPAREL 133 mg|"10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Bupivacaine liposome: Local administration"
11245375|NCT02517905|FG001|Participant Flow|Placebo|"10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Placebo: Local administration"
11245376|NCT02517905|OG000|Outcome|EXPAREL 133 mg|"10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Bupivacaine liposome: Local administration"
11245377|NCT02517905|OG001|Outcome|Placebo|"10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Placebo: Local administration"
11245378|NCT02517905|EG000|Reported Event|EXPAREL 133 mg|"10 mL EXPAREL (bupivacaine liposome injectable suspension) injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Bupivacaine liposome: Local administration"
11245379|NCT02517905|EG001|Reported Event|Placebo|"10 mL normal saline injected into the maxilla (4 mL; 2 mL per side) and mandible (6 mL; 3 mL per side) at the end of surgery and ≥20 min after lidocaine administration~Placebo: Local administration"
11245380|NCT02517996|BG000|Baseline|1% Lidocaine|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.~Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the postsynaptic neuron membrane will not depolarize and so fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly."
11245381|NCT02517996|BG001|Baseline|Normal Saline|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.~Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction."
11245382|NCT02517996|BG002|Baseline|Total|Total of all reporting groups
11245383|NCT02517996|FG000|Participant Flow|1% Lidocaine|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.~Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the postsynaptic neuron membrane will not depolarize and so fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly."
11245384|NCT02517996|FG001|Participant Flow|Normal Saline|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.~Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction."
11245385|NCT02517996|OG000|Outcome|1% Lidocaine|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.~Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by stopping pain signals from propagating to the brain before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly."
11245386|NCT02517996|OG001|Outcome|Normal Saline|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.~Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction."
11245387|NCT02517996|EG000|Reported Event|1% Lidocaine|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.~Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by preventing pain signals before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered."
11245388|NCT02517996|EG001|Reported Event|Normal Saline|"Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.~Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction."
11245389|NCT02518048|BG000|Baseline|All Study Participants|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
11245390|NCT02518048|FG000|Participant Flow|LEO 90100 Aerosol Foam; Betesil® 2.25 mg|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
11245391|NCT02518048|OG000|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
11245392|NCT02518048|OG001|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
11245393|NCT02518048|EG000|Reported Event|All Subjects|All subjects received both medication and reporting is on the entire population.
11245394|NCT02518113|BG000|Baseline|50 mg LY3039478 + Dexamethasone|Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
10820117|NCT00054132|EG000|Reported Event|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10820118|NCT00054275|BG000|Baseline|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
10820119|NCT00054275|FG000|Participant Flow|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
11245395|NCT02518113|BG001|Baseline|75 mg LY3039478 + Dexamethasone|Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245396|NCT02518113|BG002|Baseline|100 mg LY3039478 + Dexamethasone|Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245397|NCT02518113|BG003|Baseline|125 mg LY3039478 + Dexamethasone|Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245398|NCT02518113|BG004|Baseline|Total|Total of all reporting groups
11245399|NCT02518113|FG000|Participant Flow|50 mg LY3039478 + Dexamethasone|Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245400|NCT02518113|FG001|Participant Flow|75 mg LY3039478 + Dexamethasone|Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245401|NCT02518113|FG002|Participant Flow|100 mg LY3039478 + Dexamethasone|Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245402|NCT02518113|FG003|Participant Flow|125 mg LY3039478 + Dexamethasone|Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245403|NCT02518113|OG000|Outcome|50 mg LY3039478 + Dexamethasone|Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245404|NCT02518113|OG001|Outcome|75 mg LY3039478 + Dexamethasone|Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245405|NCT02518113|OG002|Outcome|100 mg LY3039478 + Dexamethasone|Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245406|NCT02518113|OG003|Outcome|125 mg LY3039478 + Dexamethasone|Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245407|NCT02518113|OG000|Outcome|All Participants|"Part A:~50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression."
11245408|NCT02518113|OG000|Outcome|LY3039478 + Dexamethasone|LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245409|NCT02518113|OG001|Outcome|Placebo + Dexamethasone|Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
10820120|NCT00054275|OG000|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
10820121|NCT00054275|EG000|Reported Event|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
10820122|NCT00054327|BG000|Baseline|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
10820123|NCT00054327|BG001|Baseline|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
10820124|NCT00054327|BG002|Baseline|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
10820125|NCT00054327|BG003|Baseline|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
10820126|NCT00054327|BG004|Baseline|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
11245410|NCT02518113|EG000|Reported Event|50 mg LY3039478 + Dexamethasone|Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245411|NCT02518113|EG001|Reported Event|75 mg LY3039478 + Dexamethasone|Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
11245412|NCT02518113|EG002|Reported Event|100 mg LY3039478 + Dexamethasone|Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
11245413|NCT02518113|EG003|Reported Event|125 mg LY3039478 + Dexamethasone|Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
11245414|NCT02518191|BG000|Baseline|GnRHa (Gonadotrophin-releasing Hormone Analogues) Group|"Eligible patients with breast cancer treated with Gonadotrophin-releasing hormone analogues （GnRHa） while receiving chemotherapy.~Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy."
11245415|NCT02518191|BG001|Baseline|None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group|Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
11245416|NCT02518191|BG002|Baseline|Total|Total of all reporting groups
11245417|NCT02518191|FG000|Participant Flow|GnRHa Group|"Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.~GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy."
11245418|NCT02518191|FG001|Participant Flow|None GnRHa Group|Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
11245419|NCT02518191|OG000|Outcome|GnRHa (Gonadotrophin-releasing Hormone Analogues) Group|"Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.~Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy."
11245420|NCT02518191|OG001|Outcome|None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group|Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.
11245421|NCT02518191|OG000|Outcome|GnRHa Group|"Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.~GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy."
11245422|NCT02518191|OG001|Outcome|None GnRHa Group|Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
11245423|NCT02518191|EG000|Reported Event|GnRHa Group|"Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.~GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy."
11245424|NCT02518191|EG001|Reported Event|None GnRHa Group|Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
11245425|NCT02518230|BG000|Baseline|NAVA Ventilation First, Then SIMV(PC)PS Ventilation|"Subject will be randomized to NAVA ventilation first. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Subjects will cross over.~Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist~Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support"
11245426|NCT02518230|BG001|Baseline|SIMV(PC)PS Ventilation First, Then NAVA Ventilation|"Subject will be randomized to SIMV(PC)PS ventilation first. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. subjects will cross over.~Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist~Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support"
11245427|NCT02518230|BG002|Baseline|Total|Total of all reporting groups
11245428|NCT02518230|FG000|Participant Flow|NAVA Ventilation First, Then SIMV(PC)PS Ventilation|"Subject will be randomized to NAVA ventilation first. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Subjects will cross over.~Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist~Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support"
11245429|NCT02518230|FG001|Participant Flow|SIMV(PC)PS Ventilation First, Then NAVA Ventilation|"Subject will be randomized to SIMV(PC)PS ventilation first. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. Subjects will cross over~Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist~Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support"
11245430|NCT02518230|OG000|Outcome|NAVA Ventilation First, Then SIMV(PC)PS Ventilation|Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
11245431|NCT02518230|OG001|Outcome|SIMV(PC)PS Ventilation First, Then NAVA Ventilation|Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
11245432|NCT02518230|OG000|Outcome|Overall Study|Overall Study, Outcome not broken down further
11245433|NCT02518230|EG000|Reported Event|NAVA Ventilation First, Then SIMV(PC)PS Ventilation|Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
11245434|NCT02518230|EG001|Reported Event|SIMV(PC)PS Ventilation First, Then NAVA Ventilation|Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
11245435|NCT02518464|BG000|Baseline|Ticagrelor 90 mg Twice Per Day|"Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.~Ticagrelor 90 mg twice per day: Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches."
11245436|NCT02518464|FG000|Participant Flow|Ticagrelor 90 mg Twice Per Day|"Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.~Ticagrelor 90 mg twice per day: Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches."
11245437|NCT02518464|OG000|Outcome|Ticagrelor 90 mg Twice Per Day|"Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.~Ticagrelor 90 mg twice per day: Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.~40 subjects were enrolled."
11245438|NCT02518464|EG000|Reported Event|Ticagrelor 90 mg Twice Per Day|Two patients did not complete the TRACTOR Trial protocol due to adverse medication side effects, and five other patients had mild systemic symptoms which were potentially related to ticagrelor. Five additional patients reported unusual bruising while on ticagrelor but had no other clinical issues and completed the trial protocol. There were no significant bleeding issues in any patient treated with ticagrelor. All adverse medication effects were evaluated by the TRACTOR Trial DSMB. None were deemed to be a serious adverse event.
11245439|NCT02518490|BG000|Baseline|Overall Study|Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period.
11245440|NCT02518490|FG000|Participant Flow|Sapphire Lenses|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact Lenses"
11245441|NCT02518490|FG001|Participant Flow|Enfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~enfilcon A: Contact lenses"
11245442|NCT02518490|OG000|Outcome|Sapphire Lenses|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact Lenses"
11245443|NCT02518490|OG001|Outcome|Enfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~enfilcon A: Contact lenses"
11245444|NCT02518490|OG000|Outcome|Overall Study|"Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period.~Sapphire Test lens: Contact lens Enfilcon A: contact lens"
11245445|NCT02518490|EG000|Reported Event|Sapphire Lenses|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact Lenses"
11245446|NCT02518490|EG001|Reported Event|Enfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~enfilcon A: Contact lenses"
11286282|NCT02885636|BG000|Baseline|Inhaled Albuterol|"2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose~Albuterol: : Experimental: Inhaled albuterol~2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose"
11286283|NCT02885636|BG001|Baseline|Inhaled Saline Placebo|"Inhaled saline through a high efficiency nebulizer -single dose~Saline placebo: Saline inhaled through a nebulizer as a single dose"
10820127|NCT00054327|BG005|Baseline|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
11286284|NCT02885636|BG002|Baseline|Total|Total of all reporting groups
11286285|NCT02885636|FG000|Participant Flow|Inhaled Albuterol|"2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose~Albuterol: : Experimental: Inhaled albuterol~2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose"
11286286|NCT02885636|FG001|Participant Flow|Inhaled Saline Placebo|"Inhaled saline through a high efficiency nebulizer -single dose~Saline placebo: Saline inhaled through a nebulizer as a single dose"
11286287|NCT02885636|OG000|Outcome|Inhaled Albuterol|"2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose~Albuterol: : Experimental: Inhaled albuterol~2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose"
11245447|NCT02518620|BG000|Baseline|ALX-0061 150 mg q2w + MTX (C201 All Subjects)|ALX-0061 150 mg s.c. q2w + MTX
11245448|NCT02518620|BG001|Baseline|ALX-0061 150 mg q2w (C202 All Subjects)|ALX-0061 150 mg s.c. q2w
11245449|NCT02518620|BG002|Baseline|Total|Total of all reporting groups
11245450|NCT02518620|FG000|Participant Flow|ALX-0061 150 mg q2w + MTX (C201 All Subjects)|ALX-0061 150 mg s.c. q2w + methotrexate (MTX)
11245451|NCT02518620|FG001|Participant Flow|ALX-0061 150 mg q2w (C202 All Subjects)|ALX-0061 150 mg s.c. q2w
11245452|NCT02518620|OG000|Outcome|ALX-0061 150 mg q2w + MTX (C201 All Subjects)|ALX-0061 150 mg q2w + MTX
11245453|NCT02518620|OG001|Outcome|ALX-0061 150 mg q2w (C202 All Subjects)|ALX-0061 150 mg q2w
11245454|NCT02518620|OG002|Outcome|Total (C203 All Subjects)|C203 All Subjects
11245455|NCT02518620|EG000|Reported Event|ALX-0061 150 mg q2w + MTX (C201 All Subjects)|ALX-0061 150 mg s.c. q2w + MTX
11245456|NCT02518620|EG001|Reported Event|ALX-0061 150 mg q2w (C202 All Subjects)|ALX-0061 150 mg s.c. q2w
11245457|NCT02518620|EG002|Reported Event|Total|C203 All Subjects
11245458|NCT02518685|BG000|Baseline|TransPyloric Shuttle (TPS)|TransPyloric Shuttle plus lifestyle counseling
11245459|NCT02518685|BG001|Baseline|Control|Sham procedure plus lifestyle counseling.
11245460|NCT02518685|BG002|Baseline|Total|Total of all reporting groups
11245461|NCT02518685|FG000|Participant Flow|TransPyloric Shuttle (TPS)|TransPyloric Shuttle plus lifestyle counseling
11245462|NCT02518685|FG001|Participant Flow|Control|Sham procedure plus lifestyle counseling.
11245463|NCT02518685|OG000|Outcome|TransPyloric Shuttle (TPS)|"TransPyloric Shuttle plus lifestyle counseling~TransPyloric Shuttle~lifestyle counseling"
11245464|NCT02518685|OG001|Outcome|Control|"Sham procedure plus lifestyle counseling.~lifestyle counseling~Sham procedure"
11245465|NCT02518685|OG000|Outcome|TransPyloric Shuttle (TPS)|TransPyloric Shuttle plus lifestyle counseling
11245466|NCT02518685|EG000|Reported Event|TransPyloric Shuttle (TPS)|TransPyloric Shuttle plus lifestyle counseling
11245467|NCT02518685|EG001|Reported Event|Control|Sham procedure plus lifestyle counseling.
11245468|NCT02518919|BG000|Baseline|Standard|Patients will receive intravenous ketamine (1-2mg/kg)
11245469|NCT02518919|BG001|Baseline|Music Listening|"Patients will listen to music of their choice using headphones during sedation~Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones"
11245470|NCT02518919|BG002|Baseline|Child Life Intervention|"Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation~Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures."
11245471|NCT02518919|BG003|Baseline|Total|Total of all reporting groups
11245472|NCT02518919|FG000|Participant Flow|Standard|Patients will receive intravenous ketamine (1-2mg/kg)
11245473|NCT02518919|FG001|Participant Flow|Music Listening|"Patients will listen to music of their choice using headphones during sedation~Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones"
11245474|NCT02518919|FG002|Participant Flow|Child Life Intervention|"Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation~Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures."
11245475|NCT02518919|OG000|Outcome|Standard|Patients will receive intravenous ketamine (1-2mg/kg)
11245476|NCT02518919|OG001|Outcome|Music Listening|"Patients will listen to music of their choice using headphones during sedation~Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones"
11245477|NCT02518919|OG002|Outcome|Child Life Intervention|"Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation~Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures."
11245478|NCT02518919|EG000|Reported Event|Standard|Patients will receive intravenous ketamine (1-2mg/kg)
11245479|NCT02518919|EG001|Reported Event|Music Listening|"Patients will listen to music of their choice using headphones during sedation~Music listening: The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones"
11245480|NCT02518919|EG002|Reported Event|Child Life Intervention|"Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation~Child life intervention: The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures."
11245481|NCT02518971|BG000|Baseline|Tamsulosin|"0.4 mg daily for five days pre-op through post-op day one (seven total)~Tamsulosin: 0.4 mg daily"
11245482|NCT02518971|BG001|Baseline|Placebo|"One capsule daily for five days pre-op through post-op day one (seven total)~Placebo: one capsule daily"
11245483|NCT02518971|BG002|Baseline|Total|Total of all reporting groups
11245484|NCT02518971|FG000|Participant Flow|Tamsulosin|"0.4 mg daily for five days pre-op through post-op day one (seven total)~Tamsulosin: 0.4 mg daily"
11245485|NCT02518971|FG001|Participant Flow|Placebo|"One capsule daily for five days pre-op through post-op day one (seven total)~Placebo: one capsule daily"
11245486|NCT02518971|OG000|Outcome|Tamsulosin|"0.4 mg daily for five days pre-op through post-op day one (seven total)~Tamsulosin: 0.4 mg daily"
11245487|NCT02518971|OG001|Outcome|Placebo|"One capsule daily for five days pre-op through post-op day one (seven total)~Placebo: one capsule daily"
11245488|NCT02518971|EG000|Reported Event|Tamsulosin|"0.4 mg daily for five days pre-op through post-op day one (seven total)~Tamsulosin: 0.4 mg daily"
11245489|NCT02518971|EG001|Reported Event|Placebo|"One capsule daily for five days pre-op through post-op day one (seven total)~Placebo: one capsule daily"
11245490|NCT02518971|EG002|Reported Event|Not Randomized|Participants were withdrawn from study before randomization
11245491|NCT02518997|BG000|Baseline|All Enrolled Infants|"All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability.~Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring."
11245492|NCT02518997|FG000|Participant Flow|All Enrolled Infants|"All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability.~Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring."
11245493|NCT02518997|OG000|Outcome|All Enrolled Infants|Infants exposed to parental reading-all enrolled infants
11245494|NCT02518997|OG001|Outcome|Infants 3 Hours Before Reading|"Infants with oxygen saturations measured 3 hours before reading exposure~All enrolled infants"
11245495|NCT02518997|OG002|Outcome|Infants 1 Hour Before Reading Exposure|All enrolled infants. Infants with oxygen saturations measured 1 hour before reading exposure
11245496|NCT02518997|OG003|Outcome|Infants 1 Hour After Reading Exposure|"Infants with oxygen saturation data measured 1 hour after reading exposure~All enrolled infants"
11245497|NCT02518997|EG000|Reported Event|All Enrolled Infants|"All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability.~Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring."
11245498|NCT02519023|BG000|Baseline|TAP-Block With Liposomal Bupivacaine|"TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.~Liposomal Bupivacaine: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side."
11245499|NCT02519023|BG001|Baseline|Surgical Infiltration With Bupivacaine|"Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Bupivacaine: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Ultrasound: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane"
11245500|NCT02519023|BG002|Baseline|Total|Total of all reporting groups
11245501|NCT02519023|FG000|Participant Flow|TAP-Block With Liposomal Bupivacaine|"TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.~Liposomal Bupivacaine: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side."
11245502|NCT02519023|FG001|Participant Flow|Surgical Infiltration With Bupivacaine|"Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Bupivacaine: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Ultrasound: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane"
11245503|NCT02519023|OG000|Outcome|TAP-Block With Liposomal Bupivacaine|"TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.~Liposomal Bupivacaine: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side."
11245504|NCT02519023|OG001|Outcome|Surgical Infiltration With Bupivacaine|"Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Bupivacaine: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Ultrasound: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane"
11245505|NCT02519023|EG000|Reported Event|TAP-Block With Liposomal Bupivacaine|"TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.~Liposomal Bupivacaine: In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side."
11245506|NCT02519023|EG001|Reported Event|Surgical Infiltration With Bupivacaine|"Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Bupivacaine: Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.~Ultrasound: An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane"
11245507|NCT02519036|BG000|Baseline|Placebo|Participants received placebo, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245508|NCT02519036|BG001|Baseline|ISIS 443139 10 mg|Participants received ISIS 443139, 10 milligrams (mg), by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245509|NCT02519036|BG002|Baseline|ISIS 443139 30 mg|Participants received ISIS 443139, 30 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245510|NCT02519036|BG003|Baseline|ISIS 443139 60 mg|Participants received ISIS 443139, 60 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245511|NCT02519036|BG004|Baseline|ISIS 443139 90 mg|Participants received ISIS 443139, 90 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245512|NCT02519036|BG005|Baseline|ISIS 443139 120 mg|Participants received ISIS 443139, 120 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245513|NCT02519036|BG006|Baseline|Total|Total of all reporting groups
11245514|NCT02519036|FG000|Participant Flow|Placebo|Participants received placebo, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245515|NCT02519036|FG001|Participant Flow|ISIS 443139 10 mg|Participants received ISIS 443139, 10 milligrams (mg), by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245516|NCT02519036|FG002|Participant Flow|ISIS 443139 30 mg|Participants received ISIS 443139, 30 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245517|NCT02519036|FG003|Participant Flow|ISIS 443139 60 mg|Participants received ISIS 443139, 60 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245518|NCT02519036|FG004|Participant Flow|ISIS 443139 90 mg|Participants received ISIS 443139, 90 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245519|NCT02519036|FG005|Participant Flow|ISIS 443139 120 mg|Participants received ISIS 443139, 120 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245520|NCT02519036|OG000|Outcome|Placebo|Participants received placebo, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245521|NCT02519036|OG001|Outcome|ISIS 443139 10 mg|Participants received ISIS 443139, 10 milligrams (mg), by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245522|NCT02519036|OG002|Outcome|ISIS 443139 30 mg|Participants received ISIS 443139, 30 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245523|NCT02519036|OG003|Outcome|ISIS 443139 60 mg|Participants received ISIS 443139, 60 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245524|NCT02519036|OG004|Outcome|ISIS 443139 90 mg|Participants received ISIS 443139, 90 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245525|NCT02519036|OG005|Outcome|ISIS 443139 120 mg|Participants received ISIS 443139, 120 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245526|NCT02519036|OG000|Outcome|ISIS 443139 10 mg|Participants received ISIS 443139, 10 milligrams (mg), by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245527|NCT02519036|OG001|Outcome|ISIS 443139 30 mg|Participants received ISIS 443139, 30 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245528|NCT02519036|OG002|Outcome|ISIS 443139 60 mg|Participants received ISIS 443139, 60 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245529|NCT02519036|OG003|Outcome|ISIS 443139 90 mg|Participants received ISIS 443139, 90 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245530|NCT02519036|OG004|Outcome|ISIS 443139 120 mg|Participants received ISIS 443139, 120 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245531|NCT02519036|EG000|Reported Event|Placebo|Participants received placebo, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245532|NCT02519036|EG001|Reported Event|ISIS 443139 10 mg|Participants received ISIS 443139, 10 milligrams (mg), by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245533|NCT02519036|EG002|Reported Event|ISIS 443139 30 mg|Participants received ISIS 443139, 30 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245534|NCT02519036|EG003|Reported Event|ISIS 443139 60 mg|Participants received ISIS 443139, 60 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245535|NCT02519036|EG004|Reported Event|ISIS 443139 90 mg|Participants received ISIS 443139, 90 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245536|NCT02519036|EG005|Reported Event|ISIS 443139 120 mg|Participants received ISIS 443139, 120 mg, by intrathecal injection, at 4 week intervals over the course of a 13 week treatment period.
11245537|NCT02519231|BG000|Baseline|Treatment|"This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.~Naproxen: Naproxen 440mg 1x bid"
11245538|NCT02519231|BG001|Baseline|Placebo|"This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.~Placebo: Placebo tablet 1x bid"
11245539|NCT02519231|BG002|Baseline|Total|Total of all reporting groups
11245540|NCT02519231|FG000|Participant Flow|Treatment|"This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .~Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle"
11245541|NCT02519231|FG001|Participant Flow|Placebo|"This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.~Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation"
11245542|NCT02519231|OG000|Outcome|Treatment|"This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .~Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle"
11245543|NCT02519231|OG001|Outcome|Placebo|"This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.~Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation"
11245544|NCT02519231|OG000|Outcome|Treatment|"This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.~Naproxen: Naproxen 440mg 1x pid"
11245545|NCT02519231|OG001|Outcome|Placebo|"This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.~Placebo: Placebo tablet 440mg 1x pid"
11245546|NCT02519231|EG000|Reported Event|Treatment|"This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.~Naproxen: Naproxen 440mg 1x bid"
11245547|NCT02519231|EG001|Reported Event|Placebo|"This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.~Placebo: Placebo tablet 440mg 1x bid"
11245548|NCT02519244|BG000|Baseline|Robot-assisted Rehabilitation|"Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.~Ekso® (Wearable lower limb exoskeleton): The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs."
11245549|NCT02519244|FG000|Participant Flow|Robot-assisted Rehabilitation|"Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.~Ekso® (Wearable lower limb exoskeleton): The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs."
11245550|NCT02519244|OG000|Outcome|Robot-assisted Rehabilitation|"Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.~Ekso® (Wearable lower limb exoskeleton): The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs."
11245551|NCT02519244|EG000|Reported Event|Robot-assisted Rehabilitation|"Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.~Ekso® (Wearable lower limb exoskeleton): The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs."
11245552|NCT02519387|BG000|Baseline|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
11245553|NCT02519387|FG000|Participant Flow|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
10820128|NCT00054327|BG006|Baseline|Total|Total of all reporting groups
11245554|NCT02519387|OG000|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
11245555|NCT02519387|EG000|Reported Event|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
11245556|NCT02519491|BG000|Baseline|Modified Allen's Test|"The Modified Allen's Test to assess radial and ulnar patency.~Modified Allen Test: The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery."
11245557|NCT02519491|BG001|Baseline|Iphone Assessment|"iPhone assessment of radial and ulnar patency.~Iphone artery assessment: The iRADIAL iPhone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes."
11245558|NCT02519491|BG002|Baseline|Total|Total of all reporting groups
11245559|NCT02519491|FG000|Participant Flow|Modified Allen's Test|"The Modified Allen's Test to assess radial and ulnar patency.~Modified Allen Test: The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery."
11245560|NCT02519491|FG001|Participant Flow|Iphone Assessment|"iPhone assessment of radial and ulnar patency.~Iphone artery assessment: The iRADIAL iPhone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes."
11245561|NCT02519491|OG000|Outcome|Modified Allen's Test|"The Modified Allen's Test to assess radial and ulnar patency.~Modified Allen Test: The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery."
11245562|NCT02519491|OG001|Outcome|Iphone Assessment|"iPhone assessment of radial and ulnar patency.~Iphone artery assessment: The iRADIAL iPhone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes."
11245563|NCT02519491|EG000|Reported Event|Modified Allen's Test|"The Modified Allen's Test to assess radial and ulnar patency.~Modified Allen Test: The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery."
11245564|NCT02519491|EG001|Reported Event|Iphone Assessment|"iPhone assessment of radial and ulnar patency.~Iphone artery assessment: The iRADIAL iPhone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes."
11245565|NCT02519504|BG000|Baseline|Children With Duarte Galactosemia (Cases)|Pediatric subjects with Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245566|NCT02519504|BG001|Baseline|Unaffected Siblings (Controls)|Pediatric subjects without Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245567|NCT02519504|BG002|Baseline|Total|Total of all reporting groups
11245568|NCT02519504|FG000|Participant Flow|Children With Duarte Galactosemia (Cases)|Pediatric subjects with Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245569|NCT02519504|FG001|Participant Flow|Unaffected Siblings (Controls)|Pediatric subjects without Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245570|NCT02519504|OG000|Outcome|Children With Duarte Galactosemia (Cases)|Pediatric subjects with Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245571|NCT02519504|OG001|Outcome|Unaffected Siblings (Controls)|Pediatric subjects without Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
10820129|NCT00054327|FG000|Participant Flow|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
11245572|NCT02519504|EG000|Reported Event|Children With Duarte Galactosemia (Cases)|Pediatric subjects with Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245573|NCT02519504|EG001|Reported Event|Unaffected Siblings (Controls)|Pediatric subjects without Duarte galactosemia undergoing direct assessments of cognitive skills (memory, executive function, and auditory processing), communication processes (speech and language), physical development (including motor skills, coordination, and occurrence of tremors), and social-emotional development.
11245574|NCT02519595|BG000|Baseline|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
11245575|NCT02519595|BG001|Baseline|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
11245576|NCT02519595|BG002|Baseline|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
11245577|NCT02519595|BG003|Baseline|Total|Total of all reporting groups
11245578|NCT02519595|FG000|Participant Flow|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
11245579|NCT02519595|FG001|Participant Flow|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
11245580|NCT02519595|FG002|Participant Flow|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
11245581|NCT02519595|OG000|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
11245582|NCT02519595|OG001|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
11245583|NCT02519595|OG002|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
11245584|NCT02519595|EG000|Reported Event|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
11245585|NCT02519595|EG001|Reported Event|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
11245586|NCT02519595|EG002|Reported Event|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
11245587|NCT02519621|BG000|Baseline|NPWT PRO Without Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage~NPWT PRO without irrigation: NPWT PRO without irrigation."
11245588|NCT02519621|BG001|Baseline|NPWT PRO With Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).~NPWT PRO with irrigation: NPWT PRO with irrigation (saline)"
11245589|NCT02519621|BG002|Baseline|KCI Ulta NPWT|"KCI Ulta NPWT without irrigation.~KCI Ulta: KCI Ulta NPWT without irrigation"
11245590|NCT02519621|BG003|Baseline|Total|Total of all reporting groups
11245591|NCT02519621|FG000|Participant Flow|NPWT PRO Without Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage~NPWT PRO without irrigation: NPWT PRO without irrigation."
11245592|NCT02519621|FG001|Participant Flow|NPWT PRO With Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).~NPWT PRO with irrigation: NPWT PRO with irrigation (saline)"
11245593|NCT02519621|FG002|Participant Flow|KCI Ulta NPWT|"KCI Ulta NPWT without irrigation.~KCI Ulta: KCI Ulta NPWT without irrigation"
11245594|NCT02519621|OG000|Outcome|NPWT PRO Without Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage~NPWT PRO without irrigation: NPWT PRO without irrigation."
11245595|NCT02519621|OG001|Outcome|NPWT PRO With Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).~NPWT PRO with irrigation: NPWT PRO with irrigation (saline)"
11245596|NCT02519621|OG002|Outcome|KCI Ulta NPWT|"KCI Ulta NPWT without irrigation.~KCI Ulta: KCI Ulta NPWT without irrigation"
11245597|NCT02519621|EG000|Reported Event|NPWT PRO Without Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage~NPWT PRO without irrigation: NPWT PRO without irrigation."
11245598|NCT02519621|EG001|Reported Event|NPWT PRO With Irrigation|"Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).~NPWT PRO with irrigation: NPWT PRO with irrigation (saline)"
11245599|NCT02519621|EG002|Reported Event|KCI Ulta NPWT|"KCI Ulta NPWT without irrigation.~KCI Ulta: KCI Ulta NPWT without irrigation"
11245600|NCT02519842|BG000|Baseline|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245601|NCT02519842|BG001|Baseline|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245602|NCT02519842|BG002|Baseline|Total|Total of all reporting groups
10820130|NCT00054327|FG001|Participant Flow|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
10820131|NCT00054327|FG002|Participant Flow|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
10820132|NCT00054327|FG003|Participant Flow|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
10820133|NCT00054327|FG004|Participant Flow|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
10820134|NCT00054327|FG005|Participant Flow|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
10820135|NCT00054327|OG000|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
10820136|NCT00054327|OG001|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
10820137|NCT00054327|OG002|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
10820138|NCT00054327|OG003|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
10820139|NCT00054327|OG004|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
10820140|NCT00054327|OG005|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
10820141|NCT00054327|EG000|Reported Event|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
10820142|NCT00054327|EG001|Reported Event|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
10820143|NCT00054327|EG002|Reported Event|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
10820144|NCT00054327|EG003|Reported Event|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
10820145|NCT00054327|EG004|Reported Event|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
10820146|NCT00054327|EG005|Reported Event|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
10820147|NCT00054353|BG000|Baseline|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10848076|NCT00288067|BG000|Baseline|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
10969591|NCT00906698|OG001|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969592|NCT00906698|OG002|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969593|NCT00906698|OG003|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969594|NCT00906698|OG004|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969595|NCT00906698|OG005|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969596|NCT00906698|OG000|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969597|NCT00906698|OG001|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
10969598|NCT00906698|OG000|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
10969599|NCT00906698|OG001|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
10969600|NCT00906698|OG000|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
10969601|NCT00906698|OG001|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
10969602|NCT00906698|OG000|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
10969603|NCT00906698|OG001|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
10969604|NCT00906698|OG000|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
10969605|NCT00906698|OG001|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
10969606|NCT00906698|OG000|Outcome|in Presence of Afatinib|60 mg/m^2 vinorelbine per os in presence of Afatinib
10969607|NCT00906698|OG001|Outcome|in Absence of Afatinib|60 mg/m^2 vinorelbine per os in absence of Afatinib
10969608|NCT00906698|OG000|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
10969609|NCT00906698|OG001|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
10969610|NCT00906698|OG000|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
10969611|NCT00906698|OG001|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
10969612|NCT00906698|OG000|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
10969613|NCT00906698|OG001|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
10969614|NCT00906698|EG000|Reported Event|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969615|NCT00906698|EG001|Reported Event|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969616|NCT00906698|EG002|Reported Event|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969617|NCT00906698|EG003|Reported Event|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969618|NCT00906698|EG004|Reported Event|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969619|NCT00906698|EG005|Reported Event|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
10969620|NCT00906776|BG000|Baseline|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
10969621|NCT00906776|BG001|Baseline|Autogenous Bone|Autogenous bone from the patient
10969622|NCT00906776|BG002|Baseline|Total|Total of all reporting groups
10969623|NCT00906776|FG000|Participant Flow|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
10969624|NCT00906776|FG001|Participant Flow|Autogenous Bone|Autogenous bone from the patient
10969625|NCT00906776|OG000|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
10969626|NCT00906776|OG001|Outcome|Autogenous Bone|Autogenous bone from the patient
10969627|NCT00906776|EG000|Reported Event|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
10969628|NCT00906776|EG001|Reported Event|Autogenous Bone|Autogenous bone from the patient
10969629|NCT00906789|BG000|Baseline|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard CAD Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested"
10969630|NCT00906789|FG000|Participant Flow|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard and SoftView Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, Two types of software are tested: SoftView (TM). SoftView decreases the visibility of the ribs and clavicles on chest radiographs. OnGuard marks locations on chest radiographs meeting some of the software signs of lung nodules, a method often called Computer Aided Detection (CADe)."
11215535|NCT02300025|BG003|Baseline|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215536|NCT02300025|BG004|Baseline|Total|Total of all reporting groups
11215537|NCT02300025|FG000|Participant Flow|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
11215538|NCT02300025|FG001|Participant Flow|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215539|NCT02300025|FG002|Participant Flow|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215540|NCT02300025|FG003|Participant Flow|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215541|NCT02300025|OG000|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215542|NCT02300025|OG001|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215543|NCT02300025|OG002|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215544|NCT02300025|OG003|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215545|NCT02300025|OG003|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215546|NCT02300025|EG000|Reported Event|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215547|NCT02300025|EG001|Reported Event|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215548|NCT02300025|EG002|Reported Event|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215549|NCT02300025|EG003|Reported Event|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
11215550|NCT02300077|BG000|Baseline|Control|"Control (Intra-operative administration of opioids, other than methadone)~Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone"
11215551|NCT02300077|BG001|Baseline|Treatment Methadone 0.1 mg/kg|"methadone 0.1 mg/kg~methadone: Escalating dose of methadone up to .3mg/kg."
11215552|NCT02300077|BG002|Baseline|Treatment Methadone 0.15 mg/kg|methadone: Escalating dose of methadone up to .3mg/kg.
11215553|NCT02300077|BG003|Baseline|Total|Total of all reporting groups
11215554|NCT02300077|FG000|Participant Flow|Control|Control (Intra-operative administration of opioids, other than methadone)
11215555|NCT02300077|FG001|Participant Flow|Treatment Methadone 0.1 mg/kg|"methadone~methadone: Escalating dose of methadone up to .3mg/kg."
11215556|NCT02300077|FG002|Participant Flow|Treatment Methadone 0.15 mg/kg|methadone
11215557|NCT02300077|OG000|Outcome|Control|"Control (Intra-operative administration of opioids, other than methadone)~Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone"
11215558|NCT02300077|OG001|Outcome|Treatment Methadone 0.1 mg/kg|"methadone 0.1 mg/kg~methadone: Escalating dose of methadone up to .3mg/kg."
11215559|NCT02300077|OG002|Outcome|Treatment Methadone 0.15 mg/kg|methadone: Escalating dose of methadone up to .3mg/kg.
11215560|NCT02300077|EG000|Reported Event|Control|"Control (Intra-operative administration of opioids, other than methadone)~Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone"
11245603|NCT02519842|FG000|Participant Flow|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245604|NCT02519842|FG001|Participant Flow|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245605|NCT02519842|FG002|Participant Flow|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-hydroxytryptamine 3 (5-HT3) antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245606|NCT02519842|OG000|Outcome|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245607|NCT02519842|OG001|Outcome|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245608|NCT02519842|OG002|Outcome|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-HT3 antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245609|NCT02519842|EG000|Reported Event|Fosaprepitant Regimen Cycle 1|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245610|NCT02519842|EG001|Reported Event|Control Regimen Cycle 1|Participants received a single dose of matched placebo for fosaprepitant IV on Day 1 prior to chemotherapy plus ondansetron IV on Day 1 prior to chemotherapy and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may have also received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245611|NCT02519842|EG002|Reported Event|Fosaprepitant Regimen Cycles 2-6|Participants received a single dose of fosaprepitant 150 mg (or age-based adjustment) IV on Day 1 prior to chemotherapy plus a 5-hydroxytryptamine 3 (5-HT3) antagonist on Day 1 prior to chemotherapy and per product label or standard of care. Participants may also have received dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
11245612|NCT02519855|BG000|Baseline|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
11245613|NCT02519855|BG001|Baseline|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
11245614|NCT02519855|BG002|Baseline|Total|Total of all reporting groups
11245615|NCT02519855|FG000|Participant Flow|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
11245616|NCT02519855|FG001|Participant Flow|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
11245617|NCT02519855|OG000|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
11245618|NCT02519855|OG001|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
11245619|NCT02519855|EG000|Reported Event|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
11245620|NCT02519855|EG001|Reported Event|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
11245621|NCT02520089|BG000|Baseline|Bone Autograft|"The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates.~bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties"
11245622|NCT02520089|BG001|Baseline|Platelet Rich Plasma Plus Bone Autograft|"Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest.~Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis"
11245623|NCT02520089|BG002|Baseline|Total|Total of all reporting groups
10969631|NCT00906789|OG000|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
11286288|NCT02885636|OG001|Outcome|Inhaled Saline Placebo|"Inhaled saline through a high efficiency nebulizer -single dose~Saline placebo: Saline inhaled through a nebulizer as a single dose"
10969632|NCT00906789|OG001|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
11215561|NCT02300077|EG001|Reported Event|Treatment Methadone 0.1 mg/kg|"methadone 0.1 mg/kg~methadone: Escalating dose of methadone up to .3mg/kg."
10969633|NCT00906789|OG000|Outcome|Radiologists Using OnGuard Software: Difference of 1.0 and 5.1|Radiologists using OnGuard software. Two different versions were tested. OnGuard 1.0 and OnGuard 5.1. This software uses a computer algorithm to identify non-calcified lung nodules consistent with lung cancer. The value presented is the average difference in the areas under the LROC curve as demonstrated for the participating radiologists. The value for OnGuard 5.1 was subtracted from that of OnGuard 1.0, so a negative value indicates that OnGuard 5.1 had a higher value than OnGuard 1.0. The 95% confidence interval indicates that the OnGuard 5.1 was significantly improved.
10969634|NCT00906789|EG000|Reported Event|Participants|The 15 radiologists who participated
10969635|NCT00906945|BG000|Baseline|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969636|NCT00906945|BG001|Baseline|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969637|NCT00906945|BG002|Baseline|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969638|NCT00906945|BG003|Baseline|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969639|NCT00906945|BG004|Baseline|Dose Level 5 (Includes MTD-Phase II)|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969640|NCT00906945|BG005|Baseline|Total|Total of all reporting groups
11215562|NCT02300077|EG002|Reported Event|Treatment Methadone 0.15 mg/kg|methadone: Escalating dose of methadone up to .3mg/kg.
11215563|NCT02300103|BG000|Baseline|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
11215564|NCT02300103|FG000|Participant Flow|SOF/VEL+RBV|Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks
11215565|NCT02300103|OG000|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
11215566|NCT02300103|EG000|Reported Event|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
11215567|NCT02300129|BG000|Baseline|All Study Participants (Intent To Treat Population)|One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
11215568|NCT02300129|FG000|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
11215569|NCT02300129|FG001|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
11215570|NCT02300129|FG002|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
10969641|NCT00906945|FG000|Participant Flow|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969642|NCT00906945|FG001|Participant Flow|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969643|NCT00906945|FG002|Participant Flow|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
10969644|NCT00906945|FG003|Participant Flow|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11245624|NCT02520089|FG000|Participant Flow|Bone Autograft|"The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates.~bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties"
11245625|NCT02520089|FG001|Participant Flow|Platelet Rich Plasma Plus Bone Autograft|"Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest.~Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis"
11245626|NCT02520089|OG000|Outcome|Bone Autograft|"The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates.~bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties"
11245627|NCT02520089|OG001|Outcome|Platelet Rich Plasma Plus Bone Autograft|"Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest.~Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis"
11245628|NCT02520089|EG000|Reported Event|Bone Autograft|"The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates.~bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties"
11245629|NCT02520089|EG001|Reported Event|Platelet Rich Plasma Plus Bone Autograft|"Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest.~Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis"
11245630|NCT02520284|BG000|Baseline|Andecaliximab Every 2 Weeks|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks."
11245631|NCT02520284|BG001|Baseline|Andecaliximab Weekly|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks."
11245632|NCT02520284|BG002|Baseline|Placebo|"Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks."
11245633|NCT02520284|BG003|Baseline|Total|Total of all reporting groups
11245634|NCT02520284|FG000|Participant Flow|Andecaliximab Every 2 Weeks|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.~Blinded Maintenance Phase: Participants who achieved endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission and/or Mayo Clinical Score (MCS) response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks."
11245635|NCT02520284|FG001|Participant Flow|Andecaliximab Weekly|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks."
11245636|NCT02520284|FG002|Participant Flow|Placebo|"Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks."
11245637|NCT02520284|OG000|Outcome|Andecaliximab Every 2 Weeks|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks."
11245638|NCT02520284|OG001|Outcome|Andecaliximab Weekly|"Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks."
11245639|NCT02520284|OG002|Outcome|Placebo|"Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.~Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.~Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks."
11245640|NCT02520284|EG000|Reported Event|Blinded Induction Phase: Andecaliximab Every 2 Weeks|Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
11245641|NCT02520284|EG001|Reported Event|Blinded Induction Phase: Andecaliximab Every Weeks|Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
11245642|NCT02520284|EG002|Reported Event|Blinded Induction Phase: Placebo|Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
11245643|NCT02520284|EG003|Reported Event|Blinded Maintenance Phase: Andecaliximab Every 2 Weeks|Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
11245644|NCT02520284|EG004|Reported Event|Blinded Maintenance Phase: Andecaliximab Every Week|Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
11245645|NCT02520284|EG005|Reported Event|Blinded Maintenance Phase: Placebo|Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
11245646|NCT02520284|EG006|Reported Event|Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks|Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
11245647|NCT02520284|EG007|Reported Event|Open-Label Maintenance Phase From Andecaliximab Every Week|Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
11245648|NCT02520284|EG008|Reported Event|Open-Label Maintenance Phase From Placebo|Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
11245649|NCT02520310|BG000|Baseline|AVJ-514|The AVJ-514 system: Patients receiving AVJ-514 device
11245650|NCT02520310|FG000|Participant Flow|AVJ-514|This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.
11245651|NCT02520310|OG000|Outcome|AVJ-514|The AVJ-514 system: Patients receiving AVJ-514 device
11245652|NCT02520310|OG000|Outcome|AVJ-514|"The AVJ-514 system~AVJ-514: Patients receiving AVJ-514 device"
11245653|NCT02520310|OG000|Outcome|AVJ-514|This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.
11245654|NCT02520310|EG000|Reported Event|AVJ-514|AVJ-514: Patients receiving AVJ-514 device
11245655|NCT02520388|BG000|Baseline|HLD200 (Methylphenidate)|At the start of the Randomized Placebo-controlled Test Phase (Visit 2), subjects were randomized to receive either HLD200 or placebo. Subjects instructed to begin dosing at 40mg each evening (8:00 pm ±30 minutes) for 1 week, with scheduled titration, as medically indicated and tolerated, over the subsequent 2 weeks to 60 mg (Visit 3) and 80 mg (Visit 4) and/or a dose not to exceed 3.7 mg/kg (based on the subject's most recently assessed weight). Following dose escalation above 40 mg (i.e., after Visit 3), subjects were permitted to reduce the dose by 1 step (i.e., from 60 to 40 mg or from 80 to 60 mg) if necessary for safety or tolerability. Subjects who were unable to tolerate a dose of at least 40 mg during the final (third) week of treatment, from Visit 4 to 5, were discontinued. Subjects were also permitted to adjust the timing of the evening dosing at Visits 3 and 4 in increments of 30 to 60 minutes/week to achieve optimal morning control of observed ADHD symptoms; however, the dose was not to be taken any later than 9:30 pm or any earlier than 6:30 pm, regardless of the ±30-minute dosing window.
11245656|NCT02520388|BG001|Baseline|Placebo|"At the start of the randomized placebo-controlled Test Phase (Visit 2), subjects were randomized to receive either HLD200 or placebo. Placebo capsules were colour and weight matched to the active HLD200 capsules.~Subjects instructed to begin dosing at 40mg each evening (8:00 pm ±30 minutes) for 1 week, with scheduled titration, as medically indicated and tolerated, over the subsequent 2 weeks to 60 mg (Visit 3) and 80 mg (Visit 4) and/or a dose not to exceed 3.7 mg/kg (based on the subject's most recently assessed weight). Following dose escalation above 40 mg (i.e., after Visit 3), subjects were permitted to reduce the dose by 1 step (i.e., from 60 to 40 mg or from 80 to 60 mg) if necessary for safety or tolerability. Subjects who were unable to tolerate a dose of at least 40 mg during the final (third) week of treatment, from Visit 4 to 5, were discontinued. Subjects were also permitted to adjust the timing of the evening dosing at Visits 3 and 4 in increments of 30 to 60 minutes/week to achieve optimal morning control of observed ADHD symptoms; however, the dose was not to be taken any later than 9:30 pm or any earlier than 6:30 pm, regardless of the ±30-minute dosing window."
11245657|NCT02520388|BG002|Baseline|Total|Total of all reporting groups
11245658|NCT02520388|FG000|Participant Flow|HLD200 (Methylphenidate)|Participantas recieved HLD200 capsules (containing beads with methylphenidate in a dual-coated drug-layered core; 40, 60 or 80 mg) orally once daily in the evening for 3 weeks.
11245659|NCT02520388|FG001|Participant Flow|Placebo|Participants recieved placebo (matched to HLD200 capsules, but containing microcrystalline cellulose beads in place of methylphenidate) orally once daily in the evening for 3 weeks.
11245660|NCT02520388|OG000|Outcome|HLD200 (Methylphenidate)|
11245661|NCT02520388|OG001|Outcome|Placebo|
11245662|NCT02520388|EG000|Reported Event|HLD200 (Methylphenidate)|
11245663|NCT02520388|EG001|Reported Event|Placebo|
11245664|NCT02520414|BG000|Baseline|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
11245665|NCT02520414|FG000|Participant Flow|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
11245666|NCT02520414|OG000|Outcome|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
11245667|NCT02520414|EG000|Reported Event|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
11245668|NCT02520518|BG000|Baseline|Dapagliflozin: ad Libitum Dietary Intake|"Daily oral administration of dapagliflozin with ad libitum dietary intake. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Ad libitum dietary intake"
11245669|NCT02520518|BG001|Baseline|Dapagliflozin: Weight Maintenance|"Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Weight maintenance"
11245670|NCT02520518|BG002|Baseline|Placebo: ad Libitum Dietary Intake|"Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Ad libitum dietary intake"
11245671|NCT02520518|BG003|Baseline|Placebo: Dietary Restriction|"Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Dietary restriction"
11245672|NCT02520518|BG004|Baseline|Total|Total of all reporting groups
11245673|NCT02520518|FG000|Participant Flow|Dapagliflozin: ad Libitum Dietary Intake|"Daily oral administration of dapagliflozin with ad libitum dietary intake. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Ad libitum dietary intake"
11245674|NCT02520518|FG001|Participant Flow|Dapagliflozin: Weight Maintenance|"Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Weight maintenance"
11245675|NCT02520518|FG002|Participant Flow|Placebo: ad Libitum Dietary Intake|"Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Ad libitum dietary intake"
11245676|NCT02520518|FG003|Participant Flow|Placebo: Dietary Restriction|"Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Dietary restriction"
11245677|NCT02520518|OG000|Outcome|Dapagliflozin: ad Libitum Dietary Intake|"Daily oral administration of dapagliflozin with ad libitum dietary intake. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Ad libitum dietary intake"
11245678|NCT02520518|OG001|Outcome|Dapagliflozin: Weight Maintenance|"Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Weight maintenance"
11245679|NCT02520518|OG002|Outcome|Placebo: ad Libitum Dietary Intake|"Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Ad libitum dietary intake"
11245680|NCT02520518|OG003|Outcome|Placebo: Dietary Restriction|"Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Dietary restriction"
11245681|NCT02520518|OG002|Outcome|Placebo: Dietary Restriction|"Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Dietary restriction"
11245682|NCT02520518|OG003|Outcome|Placebo: ad Libitum Dietary Intake|"Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Ad libitum dietary intake"
11245683|NCT02520518|EG000|Reported Event|Dapagliflozin: ad Libitum Dietary Intake|"Daily oral administration of dapagliflozin with ad libitum dietary intake. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Ad libitum dietary intake"
11245684|NCT02520518|EG001|Reported Event|Dapagliflozin: Weight Maintenance|"Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.~Dapagliflozin~Weight maintenance"
11245685|NCT02520518|EG002|Reported Event|Placebo: ad Libitum Dietary Intake|"Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Ad libitum dietary intake"
11286289|NCT02885636|EG000|Reported Event|Inhaled Albuterol|"2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose~Albuterol: : Experimental: Inhaled albuterol~2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose"
11245686|NCT02520518|EG003|Reported Event|Placebo: Dietary Restriction|"Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.~Placebo~Dietary restriction"
11245687|NCT02520531|BG000|Baseline|Scorpio PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.~Scorpio PS (posterior stable): Implantation of total knee prosthesis"
11245688|NCT02520531|BG001|Baseline|Scorpio NRG PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.~Scorpio NRG PS: Implantation of total knee prosthesis"
11245689|NCT02520531|BG002|Baseline|Total|Total of all reporting groups
11245690|NCT02520531|FG000|Participant Flow|Scorpio PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.~Scorpio PS (posterior stable): Implantation of total knee prosthesis"
11245691|NCT02520531|FG001|Participant Flow|Scorpio NRG PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.~Scorpio NRG PS: Implantation of total knee prosthesis"
11245692|NCT02520531|OG000|Outcome|Scorpio PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.~Scorpio PS (posterior stable): Implantation of total knee prosthesis"
11245693|NCT02520531|OG001|Outcome|Scorpio NRG PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.~Scorpio NRG PS: Implantation of total knee prosthesis"
11245694|NCT02520531|EG000|Reported Event|Scorpio PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.~Scorpio PS (posterior stable): Implantation of total knee prosthesis"
11245695|NCT02520531|EG001|Reported Event|Scorpio NRG PS|"Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.~Scorpio NRG PS: Implantation of total knee prosthesis"
11245696|NCT02521181|BG000|Baseline|Lower Dose Sodium Bicarbonate|"Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)"
11245697|NCT02521181|BG001|Baseline|Higher Dose Sodium Bicarbonate|"Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)"
11245698|NCT02521181|BG002|Baseline|Placebo|"Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate"
10969645|NCT00906945|FG004|Participant Flow|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11245699|NCT02521181|BG003|Baseline|Total|Total of all reporting groups
11245700|NCT02521181|FG000|Participant Flow|Lower Dose Sodium Bicarbonate|"Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)"
11245701|NCT02521181|FG001|Participant Flow|Higher Dose Sodium Bicarbonate|"Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)"
11245702|NCT02521181|FG002|Participant Flow|Placebo|"Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate"
11245703|NCT02521181|OG000|Outcome|Lower Dose Sodium Bicarbonate|"Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)"
11245704|NCT02521181|OG001|Outcome|Higher Dose Sodium Bicarbonate|"Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)"
11245705|NCT02521181|OG002|Outcome|Placebo|"Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate"
11245706|NCT02521181|EG000|Reported Event|Lower Dose Sodium Bicarbonate|"Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)"
11245707|NCT02521181|EG001|Reported Event|Higher Dose Sodium Bicarbonate|"Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)"
11245708|NCT02521181|EG002|Reported Event|Placebo|"Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)~Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate"
11245709|NCT02521259|BG000|Baseline|Low Bispectral Index (BIS) Group|"BIS range under 40~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245710|NCT02521259|BG001|Baseline|Normal BIS Group|"BIS range from 40 to 60~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245711|NCT02521259|BG002|Baseline|Total|Total of all reporting groups
11245712|NCT02521259|FG000|Participant Flow|Normal Bispectral Index (BIS) Group|"Bispectral index (BIS) range from 40 to 60~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245713|NCT02521259|FG001|Participant Flow|Low Bispectral Index (BIS) Group|"BIS range under 40~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245714|NCT02521259|OG000|Outcome|Low Bispectral Index (BIS) Group|"BIS range under 40~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245715|NCT02521259|OG001|Outcome|Normal BIS Group|"BIS range from 40 to 60~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245716|NCT02521259|EG000|Reported Event|Low Bispectral Index (BIS) Group|"BIS range under 40~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245717|NCT02521259|EG001|Reported Event|Normal BIS Group|"BIS range from 40 to 60~BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."
11245718|NCT02521376|BG000|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment received entospletinib (ENTO) 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245719|NCT02521376|BG001|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245720|NCT02521376|BG002|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245721|NCT02521376|BG003|Baseline|Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245722|NCT02521376|BG004|Baseline|Total|Total of all reporting groups
11245723|NCT02521376|FG000|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment received entospletinib (ENTO) 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245724|NCT02521376|FG001|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245725|NCT02521376|FG002|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245726|NCT02521376|FG003|Participant Flow|Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245727|NCT02521376|OG000|Outcome|Cohort 1: Moderate Hepatic Impairment Smoking|Participants with moderate hepatic impairment who are smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245728|NCT02521376|OG001|Outcome|Cohort 1: Moderate Hepatic Impairment Non-smoking|Participants with moderate hepatic impairment who are non-smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245729|NCT02521376|OG002|Outcome|Cohort 1: Healthy Control Matched to Smoking|Participants with normal hepatic function who are smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245730|NCT02521376|OG003|Outcome|Cohort 1: Healthy Control Matched to Non-smoking|Participants with normal hepatic function who are non-smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245731|NCT02521376|OG004|Outcome|Cohort 2: Severe Hepatic Impairment|Participants with severe hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245732|NCT02521376|OG005|Outcome|Cohort 2: Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245733|NCT02521376|OG006|Outcome|Cohort 3: Mild Hepatic Impairment|Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245734|NCT02521376|OG007|Outcome|Cohort 3: Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245735|NCT02521376|OG000|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment received entospletinib (ENTO) 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245736|NCT02521376|OG001|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245737|NCT02521376|OG002|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245738|NCT02521376|OG003|Outcome|Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245739|NCT02521376|EG000|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment received entospletinib (ENTO) 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
10848077|NCT00288067|FG000|Participant Flow|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
11245740|NCT02521376|EG001|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245741|NCT02521376|EG002|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245742|NCT02521376|EG003|Reported Event|Healthy Control|Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.
11245743|NCT02521766|BG000|Baseline|Cohort 1|HMIOL implantation with no optic exchange
11245744|NCT02521766|BG001|Baseline|Cohort 2|HMIOL implantation with optic exchange
11245745|NCT02521766|BG002|Baseline|Total|Total of all reporting groups
11245746|NCT02521766|FG000|Participant Flow|Cohort 1|HMIOL implantation with no optic exchange
11245747|NCT02521766|FG001|Participant Flow|Cohort 2|HMIOL implantation with optic exchange
11245748|NCT02521766|OG000|Outcome|All HMIOL Cohort|HMIOL implantation with or without optic exchange
11245749|NCT02521766|OG000|Outcome|Cohort 1|HMIOL implantation with no optic exchange
11245750|NCT02521766|OG000|Outcome|Cohort 2|HMIOL implantation with optic exchange
11245751|NCT02521766|OG000|Outcome|Fellow Eye|IOL implantation per standard of care
11245752|NCT02521766|OG000|Outcome|Cohort 2 Day 1 Post-optic Exchange|HMIOL implantation with optic exchange
11245753|NCT02521766|OG001|Outcome|Cohort 2 Week 1 Post-optic Exchange|HMIOL implantation with optic exchange
11245754|NCT02521766|OG002|Outcome|Cohort 2 Month 1 Post-optic Exchange|HMIOL implantation with optic exchange
11245755|NCT02521766|OG003|Outcome|Cohort 2 Month 3 Post-optic Exchange|HMIOL implantation with optic exchange
11245756|NCT02521766|OG004|Outcome|Cohort 2 Month 6 Post-optic Exchange|HMIOL implantation with optic exchange
11245757|NCT02521766|OG005|Outcome|Cohort 2 Month 12 Post-optic Exchange|HMIOL implantation with optic exchange
11245758|NCT02521766|EG000|Reported Event|Cohort 1 (Ocular)|"HMIOL implantation with no optic exchange~Events reported in this group occurred in the study eye from time of consent to study exit (up to 15 months)"
11245759|NCT02521766|EG001|Reported Event|Cohort 2 Pre-exchange (Ocular)|"HMIOL implantation pre-optic exchange~Events reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months)"
11245760|NCT02521766|EG002|Reported Event|Cohort 2 Post-exchange (Ocular)|"HMIOL implantation post-optic exchange~Events reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months)"
11245761|NCT02521766|EG003|Reported Event|Fellow Eye (Ocular)|"IOL per standard of care~Events reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2)"
11245762|NCT02521766|EG004|Reported Event|Systemic (Non-ocular)|Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2)
11245763|NCT02521792|BG000|Baseline|Palovarotene|Subjects experiencing an eligible flare-up received a weight-based equivalent dose of palovarotene 10 mg orally once daily for 14 days, followed by 5 mg once daily for 28 days. If treatment was extended beyond 6 weeks (if deemed necessary by the Investigator), the palovarotene dose-equivalent of 5 mg was to be administered (in 2-week increments) until the flare-up resolved.
11245764|NCT02521792|FG000|Participant Flow|Palovarotene|Subjects experiencing an eligible flare-up received a weight-based equivalent dose of palovarotene 10 milligram (mg) orally once daily for 14 days, followed by 5 mg once daily for 28 days. If treatment was extended beyond 6 weeks (if deemed necessary by the Investigator), the palovarotene dose-equivalent of 5 mg was to be administered (in 2-week increments) until the flare-up resolved.
11245765|NCT02521792|OG000|Outcome|Palovarotene|Subjects experiencing an eligible flare-up received a weight-based equivalent dose of palovarotene 10 mg orally once daily for 14 days, followed by 5 mg once daily for 28 days. If treatment was extended beyond 6 weeks (if deemed necessary by the Investigator), the palovarotene dose-equivalent of 5 mg was to be administered (in 2-week increments) until the flare-up resolved.
11245766|NCT02521792|EG000|Reported Event|Palovarotene|Eligible subjects received a weight-based equivalent dose of palovarotene 10 mg orally once daily for 14 days, followed by 5 mg once daily for 28 days during flare-ups. If treatment was extended beyond 6 weeks (if deemed necessary by the Investigator), a weight-based equivalent dose of 5 mg was to be administered in 2-week increments.
11245767|NCT02521870|BG000|Baseline|Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5."
11245768|NCT02521870|BG001|Baseline|Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1."
11245769|NCT02521870|BG002|Baseline|Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8."
11245770|NCT02521870|BG003|Baseline|Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2."
11245771|NCT02521870|BG004|Baseline|HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6."
11245772|NCT02521870|BG005|Baseline|HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3."
11245773|NCT02521870|BG006|Baseline|HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7."
11245774|NCT02521870|BG007|Baseline|HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4."
11245775|NCT02521870|BG008|Baseline|Total|Total of all reporting groups
11245776|NCT02521870|FG000|Participant Flow|SD-101 1 mg|Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245777|NCT02521870|FG001|Participant Flow|SD-101 2 mg|Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245778|NCT02521870|FG002|Participant Flow|SD-101 4 mg|Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245779|NCT02521870|FG003|Participant Flow|SD-101 8 mg|Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245780|NCT02521870|FG004|Participant Flow|SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma|Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245781|NCT02521870|FG005|Participant Flow|SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma|Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245782|NCT02521870|FG006|Participant Flow|SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC|Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245783|NCT02521870|FG007|Participant Flow|SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC|Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11286290|NCT02885636|EG001|Reported Event|Inhaled Saline Placebo|"Inhaled saline through a high efficiency nebulizer -single dose~Saline placebo: Saline inhaled through a nebulizer as a single dose"
10969646|NCT00906945|FG005|Participant Flow|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11245784|NCT02521870|FG008|Participant Flow|SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma|Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245785|NCT02521870|FG009|Participant Flow|SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC|Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245786|NCT02521870|FG010|Participant Flow|SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC|Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245787|NCT02521870|FG011|Participant Flow|SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma|Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245788|NCT02521870|OG000|Outcome|SD-101 1 mg|Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245789|NCT02521870|OG001|Outcome|SD-101 2 mg|Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245790|NCT02521870|OG002|Outcome|SD-101 4 mg|Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245791|NCT02521870|OG003|Outcome|SD-101 8 mg|Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245792|NCT02521870|OG004|Outcome|SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma|Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245793|NCT02521870|OG005|Outcome|SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma|Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245794|NCT02521870|OG006|Outcome|SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC|Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245795|NCT02521870|OG007|Outcome|SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC|Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245796|NCT02521870|OG008|Outcome|SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma|Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245797|NCT02521870|OG009|Outcome|SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC|Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245798|NCT02521870|OG010|Outcome|SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC|Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245799|NCT02521870|OG011|Outcome|SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma|Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
11245800|NCT02521870|OG000|Outcome|Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5."
11245801|NCT02521870|OG001|Outcome|Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1."
11245802|NCT02521870|OG002|Outcome|Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8."
11245803|NCT02521870|OG003|Outcome|Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2."
11245804|NCT02521870|OG004|Outcome|HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6."
11245805|NCT02521870|OG005|Outcome|HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3."
11245806|NCT02521870|OG006|Outcome|HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7."
11245807|NCT02521870|OG007|Outcome|HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg|"Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4."
11245808|NCT02521870|EG000|Reported Event|Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5."
11245809|NCT02521870|EG001|Reported Event|Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1."
11245810|NCT02521870|EG002|Reported Event|Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8."
11245811|NCT02521870|EG003|Reported Event|Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2."
11245812|NCT02521870|EG004|Reported Event|HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6."
10969647|NCT00906945|OG000|Outcome|Phase I (Includes Levels 1-5)|
10969648|NCT00906945|OG000|Outcome|Phase II (MTD)|
10969649|NCT00906945|OG000|Outcome|Grade 1|
11245813|NCT02521870|EG005|Reported Event|HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3."
11245814|NCT02521870|EG006|Reported Event|HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7."
11245815|NCT02521870|EG007|Reported Event|HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg|"Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.~The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4."
11245816|NCT02521948|BG000|Baseline|MANTA Vascular Closure Device (Total)|The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
11245817|NCT02521948|FG000|Participant Flow|MANTA Vascular Closure Device (Total)|The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
11245818|NCT02521948|OG000|Outcome|MANTA Vascular Closure Device (Total)|The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
11245819|NCT02521948|OG001|Outcome|14F MANTA Device|14F subgroup of MANTA device
11245820|NCT02521948|OG002|Outcome|18F MANTA Device|18F subgroup of MANTA device
11245821|NCT02521948|EG000|Reported Event|MANTA Vascular Closure Device (Total)|The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
11245822|NCT02521948|EG001|Reported Event|Device Related Adverse Events|Device related adverse events for the overall population
10969650|NCT00906945|OG001|Outcome|Grade 2|
11245823|NCT02521974|BG000|Baseline|Group 1|1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.
11245824|NCT02521974|BG001|Baseline|Group 2+3|18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose/s of the investigational vaccine.
11245825|NCT02521974|BG002|Baseline|Total|Total of all reporting groups
11245826|NCT02521974|FG000|Participant Flow|Group 1|1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.
11245827|NCT02521974|FG001|Participant Flow|Group 2+3|18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
11245828|NCT02521974|OG000|Outcome|Group 1|1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.
11245829|NCT02521974|OG001|Outcome|Group 2+3|18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
11245830|NCT02521974|OG000|Outcome|Group 2+3|18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
11245831|NCT02521974|EG000|Reported Event|Group 1|1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.
11245832|NCT02521974|EG001|Reported Event|Group 2+3|18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
11245833|NCT02522104|BG000|Baseline|Normal-renal Function|Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
11245834|NCT02522104|BG001|Baseline|Glomerular Hyperfiltration|Patients with glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.
11245835|NCT02522104|BG002|Baseline|Moderate Renal Failure|Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
11245836|NCT02522104|BG003|Baseline|Total|Total of all reporting groups
11245837|NCT02522104|FG000|Participant Flow|Normal-renal Function|Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
11245838|NCT02522104|FG001|Participant Flow|Glomerular Hyperfiltration|Patients with glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men
11245839|NCT02522104|FG002|Participant Flow|Moderate Renal Failure|Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
11245840|NCT02522104|OG000|Outcome|Normal-renal Function|Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
11245841|NCT02522104|OG001|Outcome|Glomerular Hyperfiltration|Patients with glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.
10969651|NCT00906945|OG002|Outcome|Grade 3|
10969652|NCT00906945|OG003|Outcome|Grade 4|
10969653|NCT00906945|OG004|Outcome|Grade 5|
10969654|NCT00906945|OG000|Outcome|Phase I and Phase II Participants|
11245842|NCT02522104|OG002|Outcome|Moderate Renal Failure|Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
11245843|NCT02522104|OG001|Outcome|Glomerular Hyperfiltration|Patients with Glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.
11245844|NCT02522104|OG002|Outcome|Moderate Renal Failure|Patients with Moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
11245845|NCT02522104|OG000|Outcome|Normal-renal Function|Patients with Normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
11245846|NCT02522104|EG000|Reported Event|Normal-renal Function|Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men
11245847|NCT02522104|EG001|Reported Event|Glomerular Hyperfiltration|Patients with glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.
11245848|NCT02522104|EG002|Reported Event|Moderate Renal Failure|Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
11245849|NCT02522286|BG000|Baseline|Usual Care|Standard clinical care in primary care offices
11245850|NCT02522286|BG001|Baseline|Ask 3 Questions|"Patients using 3 questions to their physicians when making medical decisions during the office visit.~Ask 3 Questions: Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare."
11245851|NCT02522286|BG002|Baseline|Open Communication|"Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.~2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.~3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow."
11245852|NCT02522286|BG003|Baseline|Ask 3 Questions + Open Communication|A combination of both the Ask 3 and Open Communication arms.
11245853|NCT02522286|BG004|Baseline|Total|Total of all reporting groups
11245854|NCT02522286|FG000|Participant Flow|Usual Care|Standard clinical care in primary care offices
11245855|NCT02522286|FG001|Participant Flow|Ask 3 Questions|"Patients using 3 questions to their physicians when making medical decisions during the office visit.~Ask 3 Questions: Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare."
11245856|NCT02522286|FG002|Participant Flow|Open Communication|"Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.~2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.~3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow."
10969655|NCT00906945|EG000|Reported Event|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11245857|NCT02522286|FG003|Participant Flow|Ask 3 Questions + Open Communication|A combination of both the Ask 3 and Open Communication arms.
11245858|NCT02522286|OG000|Outcome|Usual Care|Standard clinical care in primary care offices
11245859|NCT02522286|OG001|Outcome|Ask 3 Questions|"Patients using 3 questions to their physicians when making medical decisions during the office visit.~Ask 3 Questions: Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare."
11245860|NCT02522286|OG002|Outcome|Open Communication|"Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.~2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.~3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow."
11245861|NCT02522286|OG003|Outcome|Ask 3 Questions + Open Communication|A combination of both the Ask 3 and Open Communication arms.
11245862|NCT02522286|EG000|Reported Event|Usual Care|Standard clinical care in primary care offices
11245863|NCT02522286|EG001|Reported Event|Ask 3 Questions|"Patients using 3 questions to their physicians when making medical decisions during the office visit.~Ask 3 Questions: Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare."
11286291|NCT02886234|BG000|Baseline|Mindfulness Training (MT)|"Eight, 30-minute phone delivered MT sessions once a week for 8 weeks~Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor."
11245864|NCT02522286|EG002|Reported Event|Open Communication|"Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.~2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.~3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow."
11245865|NCT02522286|EG003|Reported Event|Ask 3 Questions + Open Communication|A combination of both the Ask 3 and Open Communication arms.
11245866|NCT02522299|BG000|Baseline|All Placebo|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
11245867|NCT02522299|BG001|Baseline|All NEMI|Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
11245868|NCT02522299|BG002|Baseline|Total|Total of all reporting groups
11245869|NCT02522299|FG000|Participant Flow|All Placebo|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
11245870|NCT02522299|FG001|Participant Flow|All NEMI|Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
11245871|NCT02522299|OG000|Outcome|All NEMI|Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
11245872|NCT02522299|OG000|Outcome|All Placebo|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
11245873|NCT02522299|OG000|Outcome|All NEMI/All Placebo|This arm is a comparison of All NEMI and All Placebo Arm
11245874|NCT02522299|OG001|Outcome|All NEMI|Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
11245875|NCT02522299|OG001|Outcome|All NEMI|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
11245876|NCT02522299|OG000|Outcome|Placebo Via DISKUS|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
11245877|NCT02522299|OG001|Outcome|NEMI 1000 mcg Via DISKUS|Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
11245878|NCT02522299|OG002|Outcome|Placebo Via ELLIPTA|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
11245879|NCT02522299|OG003|Outcome|NEMI 700 mcg Via ELLIPTA|Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
11245880|NCT02522299|OG000|Outcome|Placebo Via DISKUS|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
11245881|NCT02522299|OG002|Outcome|Placebo Via ELLIPTA|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
11245882|NCT02522299|OG003|Outcome|NEMI 700 mcg Via ELLIPTA|Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
11245883|NCT02522299|OG000|Outcome|NEMI 1000 mcg Via DISKUS|Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
11245884|NCT02522299|OG001|Outcome|NEMI 700 mcg Via ELLIPTA|Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
11245885|NCT02522299|EG000|Reported Event|Placebo Via DISKUS|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
11245886|NCT02522299|EG001|Reported Event|NEMI 1000 mcg Via DISKUS|Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
11245887|NCT02522299|EG002|Reported Event|Placebo Via ELLIPTA|Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
11245888|NCT02522299|EG003|Reported Event|NEMI 700 mcg Via ELLIPTA|Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
11245889|NCT02522325|BG000|Baseline|Study Completers|Baseline demographics for study completers
11245890|NCT02522325|FG000|Participant Flow|Placebo First, Then Phendimetrazine|Subjects were maintained on placebo for approximately 2 weeks, then they were crossed over to 210 mg phendimetrazine daily for approximately 2 weeks.
11245891|NCT02522325|FG001|Participant Flow|Phendimetrazine First, Then Placebo|Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks, then they were crossed over to placebo daily for approximately 2 weeks.
11245892|NCT02522325|OG000|Outcome|Placebo|Subjects were maintained on Placebo for at least 7 days.
11245893|NCT02522325|OG001|Outcome|Phendimetrazine|Subjects were maintained on 210 mg Phendimetrazine for at least 7 days.
11245894|NCT02522325|EG000|Reported Event|Placebo|Subjects were maintained on placebo for approximately 2 weeks.
11245895|NCT02522325|EG001|Reported Event|Phendimetrazine|Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks.
11245896|NCT02522377|BG000|Baseline|Ketamine Infusions|"Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.~Ketamine: intervenous injections"
11245897|NCT02522377|BG001|Baseline|Midazolam|"Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.~Midazolam: intervenous injections"
11245898|NCT02522377|BG002|Baseline|Total|Total of all reporting groups
11245899|NCT02522377|FG000|Participant Flow|Ketamine Infusions|"Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.~Ketamine: intervenous injections"
11245900|NCT02522377|FG001|Participant Flow|Midazolam|"Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.~Midazolam: intervenous injections"
11245901|NCT02522377|OG000|Outcome|Ketamine Infusions|"Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.~Ketamine: intervenous injections"
11245902|NCT02522377|OG001|Outcome|Midazolam|"Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.~Midazolam: intervenous injections"
11245903|NCT02522377|EG000|Reported Event|Ketamine Infusions|"Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.~Ketamine: intervenous injections"
11245904|NCT02522377|EG001|Reported Event|Midazolam|"Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.~Midazolam: intervenous injections"
11245905|NCT02522403|BG000|Baseline|Rehabilitation|"The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.~Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise"
11245906|NCT02522403|BG001|Baseline|Low Lever Laser Acupuncture|"The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.~Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect."
11245907|NCT02522403|BG002|Baseline|Total|Total of all reporting groups
11245908|NCT02522403|FG000|Participant Flow|Rehabilitation|"The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.~Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise"
11245909|NCT02522403|FG001|Participant Flow|Low Lever Laser Acupuncture|"The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.~Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect."
11245910|NCT02522403|OG000|Outcome|Rehabilitation|"The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.~Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise"
11245911|NCT02522403|OG001|Outcome|Low Lever Laser Acupuncture|"The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.~Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect."
11245912|NCT02522403|EG000|Reported Event|Rehabilitation|"The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.~Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise"
10820148|NCT00054353|BG001|Baseline|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10820149|NCT00054353|BG002|Baseline|Total|Total of all reporting groups
10820150|NCT00054353|FG000|Participant Flow|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10822069|NCT00074282|EG002|Reported Event|Arm C (Alemtuzumab: PR, <PR, PD)|"For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.~Alemtuzumab"
11245913|NCT02522403|EG001|Reported Event|Low Lever Laser Acupuncture|"The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.~Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect."
11245914|NCT02522442|BG000|Baseline|Auto BiLevel Group|Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
11245915|NCT02522442|BG001|Baseline|CPAP Group|CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
11245916|NCT02522442|BG002|Baseline|Total|Total of all reporting groups
11245917|NCT02522442|FG000|Participant Flow|Auto BiLevel Group|Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
11245918|NCT02522442|FG001|Participant Flow|CPAP Group|CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
11245919|NCT02522442|OG000|Outcome|Auto BiLevel Group|Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
11245920|NCT02522442|OG001|Outcome|CPAP Group|CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
11245921|NCT02522442|EG000|Reported Event|Auto BiLevel Group|Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
11245922|NCT02522442|EG001|Reported Event|CPAP Group|CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
11245923|NCT02522481|BG000|Baseline|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11245924|NCT02522481|FG000|Participant Flow|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11245925|NCT02522481|OG000|Outcome|CE-DSE - UE-DSE|Difference between contrast-enhanced dobutamine stress echo (CE-DSE) and unenhanced dobutamine stress echo (UE-DSE) (CE-DSE - UE-DSE)
11245926|NCT02522481|OG000|Outcome|Reader 1|Reader 1 CE-DSE
11245927|NCT02522481|OG001|Outcome|Reader 2|Reader 2 CE-DSE
11245928|NCT02522481|OG002|Outcome|Reader 3|Reader 3 CE-DSE
11245929|NCT02522481|OG000|Outcome|UE-DSE|Unenhanced DSE
11245930|NCT02522481|OG001|Outcome|CE-DSE|Contrast-enhanced DSE
10822070|NCT00074308|BG000|Baseline|Phase 1|Patients receive oral imatinib mesylate once or twice daily (400-800 mg/day) on days 1-28 and bevacizumab IV (5-10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11245931|NCT02522481|OG002|Outcome|Difference|(CE-DSE - UE-DSE)
11245932|NCT02522481|OG000|Outcome|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography
11245933|NCT02522481|EG000|Reported Event|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11245934|NCT02522494|BG000|Baseline|Intervention|Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.
11245935|NCT02522494|BG001|Baseline|Pamphlet Alone|Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
11245936|NCT02522494|BG002|Baseline|Total|Total of all reporting groups
11245937|NCT02522494|FG000|Participant Flow|Intervention|Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.
11245938|NCT02522494|FG001|Participant Flow|Pamphlet Alone|Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
11245939|NCT02522494|OG000|Outcome|Intervention|Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.
11245940|NCT02522494|OG001|Outcome|Pamphlet Alone|Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
11245941|NCT02522494|EG000|Reported Event|Intervention|Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.
11245942|NCT02522494|EG001|Reported Event|Pamphlet Alone|Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
11245943|NCT02522624|BG000|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
11245944|NCT02522624|BG001|Baseline|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
11245945|NCT02522624|BG002|Baseline|Total|Total of all reporting groups
11245946|NCT02522624|FG000|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
11245947|NCT02522624|FG001|Participant Flow|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
11245948|NCT02522624|OG000|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
11245949|NCT02522624|OG001|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
11245950|NCT02522624|EG000|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
11245951|NCT02522624|EG001|Reported Event|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
11245952|NCT02522728|BG000|Baseline|Triathlon CR|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon CR: Implantation of Knee Prosthesis"
11245953|NCT02522728|BG001|Baseline|Triathlon PS|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon PS: Implantation of Knee Prosthesis"
11245954|NCT02522728|BG002|Baseline|Total|Total of all reporting groups
11245955|NCT02522728|FG000|Participant Flow|Triathlon CR|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon CR: Implantation of Knee Prosthesis"
11245956|NCT02522728|FG001|Participant Flow|Triathlon PS|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon PS: Implantation of Knee Prosthesis"
11245957|NCT02522728|OG000|Outcome|Triathlon CR|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon CR: Implantation of Knee Prosthesis"
11245958|NCT02522728|OG001|Outcome|Triathlon PS|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon PS: Implantation of Knee Prosthesis"
11245959|NCT02522728|EG000|Reported Event|Triathlon CR|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon CR: Implantation of Knee Prosthesis"
11245960|NCT02522728|EG001|Reported Event|Triathlon PS|"Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.~Triathlon PS: Implantation of Knee Prosthesis"
11245961|NCT02522767|BG000|Baseline|Mesalamine|Mesalamine 4 g extended release granules (sachet), administered orally QD
11245962|NCT02522767|BG001|Baseline|Placebo|Placebo 4 g to match mesalamine extended release granules, administered orally QD
11245963|NCT02522767|BG002|Baseline|Total|Total of all reporting groups
11245964|NCT02522767|FG000|Participant Flow|Mesalamine|Mesalamine 4 gram (g) extended release granules (sachet), administered orally once daily (QD)
11245965|NCT02522767|FG001|Participant Flow|Placebo|Placebo 4 g to match mesalamine extended release granules, administered orally QD
11245966|NCT02522767|OG000|Outcome|Mesalamine|Mesalamine 4 g extended release granules (sachet), administered orally QD
11245967|NCT02522767|OG001|Outcome|Placebo|Placebo 4 g to match mesalamine extended release granules, administered orally QD
11245968|NCT02522767|OG002|Outcome|Mesalamine (Open-Label)|Mesalamine 4 g extended release granules (sachet), administered orally QD
11245969|NCT02522767|EG000|Reported Event|Mesalamine|Mesalamine 4 g extended release granules (sachet), administered orally QD
11245970|NCT02522767|EG001|Reported Event|Placebo|Placebo 4 g to match mesalamine extended release granules, administered orally QD
11245971|NCT02522767|EG002|Reported Event|Mesalamine (Open-Label)|Mesalamine 4 g extended release granules (sachet), administered orally QD
11245972|NCT02522780|BG000|Baseline|Mesalamine|Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.
11245973|NCT02522780|BG001|Baseline|Placebo|Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
11245974|NCT02522780|BG002|Baseline|Total|Total of all reporting groups
11245975|NCT02522780|FG000|Participant Flow|Mesalamine|Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.
11245976|NCT02522780|FG001|Participant Flow|Placebo|Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
11245977|NCT02522780|OG000|Outcome|Mesalamine|Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.
11245978|NCT02522780|OG001|Outcome|Placebo.|Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
11245979|NCT02522780|OG001|Outcome|Placebo|Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
11245980|NCT02522780|EG000|Reported Event|Mesalamine|Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.
11245981|NCT02522780|EG001|Reported Event|Placebo|Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
11245982|NCT02522845|BG000|Baseline|Compression|"Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging~Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins"
11245983|NCT02522845|BG001|Baseline|No Compression|Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
11245984|NCT02522845|BG002|Baseline|Total|Total of all reporting groups
11245985|NCT02522845|FG000|Participant Flow|Compression|"Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging~Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins"
11245986|NCT02522845|FG001|Participant Flow|No Compression|Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
11245987|NCT02522845|OG000|Outcome|Compression|"Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging~Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins"
11245988|NCT02522845|OG001|Outcome|No Compression|Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
11245989|NCT02522845|EG000|Reported Event|Compression|"Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging~Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins"
11245990|NCT02522845|EG001|Reported Event|No Compression|Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
11245991|NCT02522884|BG000|Baseline|Tack Endovascular System (6F)|Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
11245992|NCT02522884|FG000|Participant Flow|Tack Endovascular System (6F)|Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
11245993|NCT02522884|OG000|Outcome|Tack Endovascular System (6F)|Use of the study device in the superficial femoral and/or proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s)
11245994|NCT02522884|EG000|Reported Event|Tack Endovascular System (6F)|Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
11245995|NCT02523196|BG000|Baseline|HepQuant-SHUNT (HQ-Shunt)|"Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.~HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease"
11245996|NCT02523196|FG000|Participant Flow|Hepatic Venous Pressure Gradient (HVPG) and HepQuant-SHUNT (HQ|"Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.~Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test.~Hepatic Venous Pressure Gradient (HVPG): Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease~HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease"
11245997|NCT02523196|OG000|Outcome|HVPG <6 mmHg|Patients without portal hypertension
11245998|NCT02523196|OG001|Outcome|HVPG ≥6 mmHg|Patients with portal hypertension
11245999|NCT02523196|OG002|Outcome|All Patients|patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension
11246000|NCT02523196|OG000|Outcome|Hepatic Venous Pressure Gradient (HVPG)|"Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test.~Hepatic Venous Pressure Gradient (HVPG): Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease"
11246001|NCT02523196|OG001|Outcome|HepQuant-SHUNT (HQ-Shunt)|"Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.~HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease"
11246002|NCT02523196|EG000|Reported Event|Hepatic Venous Pressure Gradient (HVPG)|"Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test.~Hepatic Venous Pressure Gradient (HVPG): Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease"
11246003|NCT02523196|EG001|Reported Event|HepQuant-SHUNT (HQ-Shunt)|"Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.~HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease"
11246004|NCT02523235|BG000|Baseline|Proximal Catheter Insertion|"Adductor canal catheters: we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. The needle will be inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30"
11246005|NCT02523235|BG001|Baseline|Distal Catheter Insertion|"Adductor canal catheters: Inserted as described by Manickam et al. 2009~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout"
11246006|NCT02523235|BG002|Baseline|Total|Total of all reporting groups
11246007|NCT02523235|FG000|Participant Flow|Proximal Catheter Insertion|"Adductor canal catheters: at the medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella.~Popliteal catheters: the bifurcation of the sciatic nerve was identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (addu"
11246008|NCT02523235|FG001|Participant Flow|Distal Catheter Insertion|"Adductor canal catheters: Inserted as described by Manickam et al. 2009~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout"
11246009|NCT02523235|OG000|Outcome|Proximal Catheter Insertion|"we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout"
11246010|NCT02523235|OG001|Outcome|Distal Catheter Insertion|"Adductor canal catheters: Inserted as described by Manickam et al. 2009~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout"
11246011|NCT02523235|OG000|Outcome|Proximal Catheter Insertion|"Adductor canal catheters: we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. The needle will be inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30"
11246012|NCT02523235|EG000|Reported Event|Proximal Catheter Insertion|"Adductor canal catheters: medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the 2. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 min lock"
11246013|NCT02523235|EG001|Reported Event|Distal Catheter Insertion|"Adductor canal catheters: Inserted as described by Manickam et al. 2009~Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected.~ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout"
11246014|NCT02523586|BG000|Baseline|Oxygen Administration|"Via Simple Mask, Via Non-rebreather, Via OxyMask, Via Anesthesia Mask (head strap and J-R circuit), Via Room Air~Oxygen administration: Subjects will breathe room air for 90 seconds. FiO2 will be measured for 30 seconds. Testing of masks will be performed with oxygen set at high flow through simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jackson-Rees circuit. After placement of each mask and starting oxygen, subjects will breathe normally for 90 seconds. FiO2 will be measured for 30 seconds. After each trial, subjects will take one vital capacity breath. Between testing each mask, subjects will breathe room air for 5 minutes to confirm stability of hemodynamic status. Respiratory rate and FiO2 data will be recorded during each breath to determine oxygen percentages. At the end of the 30 second sampling period, a final measurement will be taken during a forced vital capacity breath."
11246015|NCT02523586|FG000|Participant Flow|Oxygen Administration|"Via Simple Mask, Via Non-rebreather, Via OxyMask, Via Anesthesia Mask (head strap and J-R circuit), Via Room Air~Oxygen administration: Subjects will breathe room air for 90 seconds. FiO2 will be measured for 30 seconds. Testing of masks will be performed with oxygen set at high flow through simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jackson-Rees circuit. After placement of each mask and starting oxygen, subjects will breathe normally for 90 seconds. FiO2 will be measured for 30 seconds. After each trial, subjects will take one vital capacity breath. Between testing each mask, subjects will breathe room air for 5 minutes to confirm stability of hemodynamic status. Respiratory rate and FiO2 data will be recorded during each breath to determine oxygen percentages. At the end of the 30 second sampling period, a final measurement will be taken during a forced vital capacity breath."
11246016|NCT02523586|OG000|Outcome|Simple Mask|At the lips
11246017|NCT02523586|OG001|Outcome|Closed Mask|At the lips
11246018|NCT02523586|OG002|Outcome|Non Rebreather Mask|At the lips
11246019|NCT02523586|OG003|Outcome|OxyMask|At the lips
11246020|NCT02523586|OG000|Outcome|Simple Mask|FiO2 measured at oropharyngeal location
11246021|NCT02523586|OG001|Outcome|Closed Mask|FiO2 measured at the oropharyngeal location
11246022|NCT02523586|OG002|Outcome|Non Rebreather Mask|FiO2 measured at the oropharyngeal location
11246023|NCT02523586|OG003|Outcome|OxyMask|FiO2 measured at the oropharyngeal location
11286292|NCT02886234|BG001|Baseline|Health Coaching (HC)|"Eight, 30-minute phone delivered HC sessions once a week for 8 weeks~Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics"
11286293|NCT02886234|BG002|Baseline|Total|Total of all reporting groups
11246024|NCT02523586|EG000|Reported Event|Oxygen Administration|"Simple Mask, Non Rebreather, OxyMask, Closed Mask (head strap and J-R circuit) Each group was measured at the lips and at the oropharyngeal locations~Oxygen administration: Subjects will breathe room air for 90 seconds. FiO2 will be measured for 30 seconds. Testing of masks will be performed with oxygen set at high flow through simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jackson-Rees circuit. After placement of each mask and starting oxygen, subjects will breathe normally for 90 seconds. FiO2 will be measured for 30 seconds. After each trial, subjects will take one vital capacity breath. Between testing each mask, subjects will breathe room air for 5 minutes to confirm stability of hemodynamic status. Respiratory rate and FiO2 data will be recorded during each breath to determine oxygen percentages. At the end of the 30 second sampling period, a final measurement will be taken during a forced vital capacity breath."
11246025|NCT02523599|BG000|Baseline|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246026|NCT02523599|BG001|Baseline|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246027|NCT02523599|BG002|Baseline|Total|Total of all reporting groups
11246028|NCT02523599|FG000|Participant Flow|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246029|NCT02523599|FG001|Participant Flow|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246030|NCT02523599|OG000|Outcome|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246031|NCT02523599|OG001|Outcome|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246032|NCT02523599|EG000|Reported Event|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246033|NCT02523599|EG001|Reported Event|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246034|NCT02523690|BG000|Baseline|Intervention|"Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.~Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later"
11246035|NCT02523690|BG001|Baseline|Control|"Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.~Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later"
11246036|NCT02523690|BG002|Baseline|Total|Total of all reporting groups
11246037|NCT02523690|FG000|Participant Flow|Intervention|"Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.~Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later"
11246038|NCT02523690|FG001|Participant Flow|Control|"Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.~Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later"
11246039|NCT02523690|OG000|Outcome|Intervention|"Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.~Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later"
10822071|NCT00074308|BG001|Baseline|Phase 2|Patients receive oral imatinib mesylate once or twice daily (400 mg/day) on days 1-28 and bevacizumab IV (10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptance toxicity.
11246040|NCT02523690|OG001|Outcome|Control|"Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.~Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later"
11246041|NCT02523690|EG000|Reported Event|Intervention|"Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.~Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later"
11246042|NCT02523690|EG001|Reported Event|Control|"Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.~Placebo: Oral or enteral, single dose. Oral or enteral, single dose two days later"
10822072|NCT00074308|BG002|Baseline|Total|Total of all reporting groups
11246043|NCT02523924|BG000|Baseline|18F-DCFPyL PET/CT|"Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT~18F-DCFPyL: 18F-DCFPyL PET/CT"
11246044|NCT02523924|FG000|Participant Flow|18F-DCFPyL PET/CT|"Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT~18F-DCFPyL: 18F-DCFPyL PET/CT"
11246045|NCT02523924|OG000|Outcome|18F-DCFPyL PET/CT|"Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT~18F-DCFPyL: 18F-DCFPyL PET/CT"
11246046|NCT02523924|EG000|Reported Event|18F-DCFPyL PET/CT|"Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT~18F-DCFPyL: 18F-DCFPyL PET/CT"
11246047|NCT02524054|BG000|Baseline|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
11246048|NCT02524054|BG001|Baseline|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol or placebo saline aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
11246049|NCT02524054|BG002|Baseline|Total|Total of all reporting groups
11246050|NCT02524054|FG000|Participant Flow|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
11246051|NCT02524054|FG001|Participant Flow|Aerosol Furosemide Study 2b Arm F|Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
11246052|NCT02524054|FG002|Participant Flow|Experimental: Aerosol Furosemide Study 2b Arm S|Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
11246053|NCT02524054|OG000|Outcome|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
11246054|NCT02524054|OG001|Outcome|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
11246055|NCT02524054|OG002|Outcome|Aerosol Saline Study 2b|Inhalation of saline aerosol . Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
11246056|NCT02524054|OG001|Outcome|Aerosol Furosemide Study 2b|"Inhalation of furosemide aerosol over the course of 10-15 min.~Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized."
11246057|NCT02524054|OG002|Outcome|Aerosol Saline Study 2b|"Inhalation of placebo saline aerosol over the course of 10-15 min.~Across the study 2b, these subjects experienced a single administration of furosemide aerosol on one treatment day, and a single administration of saline aerosol on a separate treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized."
11246058|NCT02524054|EG000|Reported Event|Aerosol Furosemide Study 2a|Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
11246059|NCT02524054|EG001|Reported Event|Aerosol Furosemide Study 2b|Inhalation of furosemide aerosol over the course of 10-15 min. Single administration of furosemide aerosol on one treatment day. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
11246060|NCT02524054|EG002|Reported Event|Aerosol Saline Study 2b|Inhalation of placebo saline aerosol over the course of 10-15 min. Single administration of saline aerosol. Order of Furosemide Treatment Day and Placebo Treatment Day is randomized.
11246061|NCT02524106|BG000|Baseline|Bococizumab|"150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks~Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia."
11246062|NCT02524106|BG001|Baseline|Placebo|"150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks~Placebo"
11246063|NCT02524106|BG002|Baseline|Total|Total of all reporting groups
11246064|NCT02524106|FG000|Participant Flow|Bococizumab|"150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks~Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia."
11246065|NCT02524106|FG001|Participant Flow|Placebo|"150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks~Placebo"
11246066|NCT02524106|OG000|Outcome|Bococizumab|"150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks~Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia."
11246067|NCT02524106|OG001|Outcome|Placebo|"150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks~Placebo"
11246068|NCT02524106|EG000|Reported Event|Bococizumab|"150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks~Bococizumab: PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia."
11246069|NCT02524106|EG001|Reported Event|Placebo|"150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks~Placebo"
11246070|NCT02524119|BG000|Baseline|LEE001 With Chemoembolization|"A total of 40 patients will be enrolled and undergo chemoembolization. Patients will receive LEE011 (600 mg PO once daily, 3 weeks on/1 week off) on Day 1 with chemoembolization. Patients can receive a total of 4 chemoembolization treatments within 6 month following first treatment as needed to treat initial HCC lesion.~LEE011: 600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason~Chemoembolization: Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization."
11246071|NCT02524119|FG000|Participant Flow|LEE001 With Chemoembolization|"A total of 40 patients will be enrolled and undergo chemoembolization. Patients will receive LEE011 (600 mg PO once daily, 3 weeks on/1 week off) on Day 1 with chemoembolization. Patients can receive a total of 4 chemoembolization treatments within 6 month following first treatment as needed to treat initial HCC lesion.~LEE011: 600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason~Chemoembolization: Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization."
11246072|NCT02524119|OG000|Outcome|LEE001 With Chemoembolization|"A total of 40 patients will be enrolled and undergo chemoembolization. Patients will receive LEE011 (600 mg PO once daily, 3 weeks on/1 week off) on Day 1 with chemoembolization. Patients can receive a total of 4 chemoembolization treatments within 6 month following first treatment as needed to treat initial HCC lesion.~LEE011: 600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason~Chemoembolization: Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization."
11286294|NCT02886234|FG000|Participant Flow|Mindfulness Training (MT)|"Eight, 30-minute phone delivered MT sessions once a week for 8 weeks~Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor."
11246073|NCT02524119|EG000|Reported Event|LEE001 With Chemoembolization|"A total of 40 patients will be enrolled and undergo chemoembolization. Patients will receive LEE011 (600 mg PO once daily, 3 weeks on/1 week off) on Day 1 with chemoembolization. Patients can receive a total of 4 chemoembolization treatments within 6 month following first treatment as needed to treat initial HCC lesion.~LEE011: 600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason~Chemoembolization: Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization."
11246074|NCT02524145|BG000|Baseline|Healthy Seniors|"Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246075|NCT02524145|BG001|Baseline|HFpEF|"Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246076|NCT02524145|BG002|Baseline|Healthy Young|"Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.~Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246077|NCT02524145|BG003|Baseline|Total|Total of all reporting groups
11246078|NCT02524145|FG000|Participant Flow|Healthy Seniors|"Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246079|NCT02524145|FG001|Participant Flow|HFpEF|"Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246080|NCT02524145|FG002|Participant Flow|Healthy Young|"Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.~Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246081|NCT02524145|OG000|Outcome|Healthy Seniors|"Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins. All control subjects will have a Body Mass Index (BMI) <30, with exercise histories of less than 3 days per week of aerobic exercise.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246082|NCT02524145|OG001|Outcome|HFpEF|"Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
10822073|NCT00074308|FG000|Participant Flow|Phase 1 - Dose 1|Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
11246083|NCT02524145|OG002|Outcome|Healthy Young|"Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.~Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246084|NCT02524145|EG000|Reported Event|Healthy Seniors|"Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins. All control subjects will have a Body Mass Index (BMI) <30, with exercise histories of less than 3 days per week of aerobic exercise.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
10822074|NCT00074308|FG001|Participant Flow|Phase 1 Dose 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
10822075|NCT00074308|FG002|Participant Flow|Phase 1 Dose 3|Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
10822076|NCT00074308|FG003|Participant Flow|Phase 1 Dose 4|Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
11246085|NCT02524145|EG001|Reported Event|HFpEF|"Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.~Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246086|NCT02524145|EG002|Reported Event|Healthy Young|"Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.~Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)~Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion."
11246087|NCT02524158|BG000|Baseline|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
11246088|NCT02524158|BG001|Baseline|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
11246089|NCT02524158|BG002|Baseline|Total|Total of all reporting groups
11246090|NCT02524158|FG000|Participant Flow|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
11246091|NCT02524158|FG001|Participant Flow|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
11246092|NCT02524158|OG000|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
11246093|NCT02524158|OG001|Outcome|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
11246094|NCT02524158|OG000|Outcome|Yoga|The yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population.
11246095|NCT02524158|OG000|Outcome|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
11246096|NCT02524158|OG000|Outcome|Yoga|Participants randomized at baseline to receive 2x weekly yoga for 12 weeks.
11246097|NCT02524158|EG000|Reported Event|Yoga|The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
11246098|NCT02524158|EG001|Reported Event|Delayed Treatment Control - Usual Care|Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
11246099|NCT02524418|BG000|Baseline|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
11246100|NCT02524418|FG000|Participant Flow|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
11246101|NCT02524418|OG000|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
11246102|NCT02524418|OG001|Outcome|Pancreatoscopy|These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
11246103|NCT02524418|OG000|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
11246104|NCT02524418|OG001|Outcome|Pancreatoscopy|Subject who had a Pancreatoscopy as part of their ERCP
11246105|NCT02524418|EG000|Reported Event|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
11246106|NCT02524561|BG000|Baseline|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
11246107|NCT02524561|BG001|Baseline|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
11246108|NCT02524561|BG002|Baseline|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
11246109|NCT02524561|BG003|Baseline|Total|Total of all reporting groups
11246110|NCT02524561|FG000|Participant Flow|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
11246111|NCT02524561|FG001|Participant Flow|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
11246112|NCT02524561|FG002|Participant Flow|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
11246113|NCT02524561|OG000|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
11246114|NCT02524561|OG001|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
11246115|NCT02524561|OG002|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
11246116|NCT02524561|EG000|Reported Event|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
11246117|NCT02524561|EG001|Reported Event|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
11246118|NCT02524561|EG002|Reported Event|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
11246119|NCT02524665|BG000|Baseline|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
11246120|NCT02524665|FG000|Participant Flow|MAXCLARITY II + Murad|MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
11246121|NCT02524665|OG000|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
11246122|NCT02524665|OG001|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
11246123|NCT02524665|EG000|Reported Event|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
11246124|NCT02524730|BG000|Baseline|Scorpio NRG CR Total Knee System|"Primary total knee replacement~Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System"
11246125|NCT02524730|FG000|Participant Flow|Scorpio NRG CR Total Knee System|"Primary total knee replacement~Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System"
11246126|NCT02524730|OG000|Outcome|Scorpio NRG CR Total Knee System|"Primary total knee replacement~Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System"
11246127|NCT02524730|EG000|Reported Event|Scorpio NRG CR Total Knee System|"Primary total knee replacement~Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System"
11246128|NCT02524769|BG000|Baseline|Conjugated Estrogen|"All patients in the study will receive 0.625 mg conjugated estrogen/gram to use 0.5 grams twice weekly with the applicator for 12 weeks.~conjugated estrogen: 0.625 mg conjugated estrogen/gram and instructions to use 0.5 grams twice weekly with the applicator."
11246129|NCT02524769|FG000|Participant Flow|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11246130|NCT02524769|OG000|Outcome|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11246131|NCT02524769|EG000|Reported Event|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11246132|NCT02524847|BG000|Baseline|Methoxsalen With ECP|Participants receive methoxsalen 20 µg/ml in conjunction with ECP procedure three times per week for Weeks 1 to 4, and two times per week for Weeks 5 to 12.
11246133|NCT02524847|FG000|Participant Flow|Methoxsalen With ECP|Participants receive methoxsalen 20 µg/ml in conjunction with extracorporeal photopheresis (ECP) procedure three times per week for Weeks 1 to 4, and two times per week for Weeks 5 to 12.
11246134|NCT02524847|OG000|Outcome|Methoxsalen With ECP|Participants receive methoxsalen 20 µg/ml in conjunction with ECP procedure three times per week for Weeks 1 to 4, and two times per week for Weeks 5 to 12.
11246135|NCT02524847|OG000|Outcome|All Participants|Participants receive methoxsalen 20 µg/ml in conjunction with ECP procedure three times per week for Weeks 1 to 4, and two times per week for Weeks 5 to 12.
10820151|NCT00054353|FG001|Participant Flow|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10820152|NCT00054353|OG000|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10820153|NCT00054353|OG001|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10820154|NCT00054353|OG000|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative studies"
10820155|NCT00054353|OG001|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative studies"
10820156|NCT00054353|OG000|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
10820157|NCT00054353|OG001|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
11246136|NCT02524847|EG000|Reported Event|Methoxsalen With ECP|Participants receive methoxsalen 20 µg/ml in conjunction with ECP procedure three times per week for Weeks 1 to 4, and two times per week for Weeks 5 to 12.
10822077|NCT00074308|FG004|Participant Flow|Phase 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
11246137|NCT02524977|BG000|Baseline|Educational Intervention Only|"Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.~All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.~Educational Intervention Only: Educational conference series"
11246138|NCT02524977|BG001|Baseline|Educational Intervention Plus Decision Support|"Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.~Decision Support: Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk~Educational Intervention Only: Educational conference series"
11246139|NCT02524977|BG002|Baseline|Total|Total of all reporting groups
11246140|NCT02524977|FG000|Participant Flow|Educational Intervention Only|"Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.~All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.~Educational Intervention Only: Educational conference series"
11246141|NCT02524977|FG001|Participant Flow|Educational Intervention Plus Decision Support|"Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.~Decision Support: Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk~Educational Intervention Only: Educational conference series"
11246142|NCT02524977|OG000|Outcome|Educational Intervention Only|"Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.~All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.~Educational Intervention Only: Educational conference series"
11246143|NCT02524977|OG001|Outcome|Educational Intervention Plus Decision Support|"Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.~Decision Support: Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk~Educational Intervention Only: Educational conference series"
11246144|NCT02524977|OG000|Outcome|2014|Discordant in 2014
11246145|NCT02524977|OG001|Outcome|2015|Discordant in 2015
11246146|NCT02524977|EG000|Reported Event|Educational Intervention Only|"Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.~All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.~Educational Intervention Only: Educational conference series"
10969656|NCT00906945|EG001|Reported Event|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11246147|NCT02524977|EG001|Reported Event|Educational Intervention Plus Decision Support|"Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.~Decision Support: Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk~Educational Intervention Only: Educational conference series"
11246148|NCT02525055|BG000|Baseline|Infectious Titre 1|6 participants aged 18 to 45 inoculated with 1mL containing 2.8 x 10*3 TCID50
11246149|NCT02525055|BG001|Baseline|Infectious Titre 2|6 participants aged 18 to 45 inoculated with 1mL containing 2.5 x 10*4 TCID50
11246150|NCT02525055|BG002|Baseline|Infectious Titre 3|6 participants aged 18 to 45 inoculated with 1mL containing 3.6 x 10*5 TCID50
11246151|NCT02525055|BG003|Baseline|Infectious Titre 4|6 participants aged 18 to 45 inoculated with 1mL containing 4.7 x 10*6 TCID50
11246152|NCT02525055|BG004|Baseline|Infectious Titre 5 (18 to 45 Years Old)|6 participants aged 18 to 45 inoculated with 1mL containing 3.5 x 10*5 TCID50
11246153|NCT02525055|BG005|Baseline|Infectious Titre 5 (46 to 64 Years Old)|16 participants aged 46 to 64 inoculated with 1mL containing 3.5 x 10*5 TCID50
11246154|NCT02525055|BG006|Baseline|Total|Total of all reporting groups
11246155|NCT02525055|FG000|Participant Flow|Infectious Titre 1|"Infectious titre 1:~6 subjects aged 18 to 45 received 1mL containing 2.8 x 10*3 TCID50~Infectious titre 1: 2.8 x 10*3 TCID50/mL"
11246156|NCT02525055|FG001|Participant Flow|Infectious Titre 2|"Infectious titre 2:~6 subjects aged 18 to 45 received 1mL containing 2.5 x 10*4 TCID50~Infectious titre 2: 2.5 x 10*4 TCID50/mL"
11246157|NCT02525055|FG002|Participant Flow|Infectious Titre 3|"Infectious titre 3:~6 subjects aged 18 to 45 received 1mL containing 3.6 x 10*5 TCID50~Infectious titre 3: 3.6 x 10*5 TCID50/mL"
11246158|NCT02525055|FG003|Participant Flow|Infectious Titre 4|"Infectious titre 4:~6 subjects aged 18 to 45 received 1mL containing 4.7 x 10*6 TCID50~Infectious titre 4: 4.7 x 10*6 TCID50/mL"
11246159|NCT02525055|FG004|Participant Flow|Infectious Titre 5 (18 to 45 Years Old)|"Infectious titre 5:~6 subjects aged 18 to 45 received 1mL containing 3.5 x 10*5 TCID50~Infectious titre 5: 3.5 x 10*5 TCID50/mL"
11246160|NCT02525055|FG005|Participant Flow|Infectious Titre 5 (46 to 64 Years Old)|"Infectious titre 5:~16 subjects aged 46 to 64 received 1mL containing 3.5 x 10*5 TCID50~Infectious titre 5: 3.5 x 10*5 TCID50/mL"
11246161|NCT02525055|OG000|Outcome|Infectious Titre 1|Participants aged 18 to 45 received 1mL containing 2.8 x 10*3 TCID50
11246162|NCT02525055|OG001|Outcome|Infectious Titre 2|Participants aged 18 to 45 received 1mL containing 2.5 x 10*4 TCID50
11246163|NCT02525055|OG002|Outcome|Infectious Titre 3|Participants aged 18 to 45 received 1mL containing 3.6 x 10*5 TCID50
11246164|NCT02525055|OG003|Outcome|Infectious Titre 4|Participants aged 18 to 45 received 1mL containing 4.7 x 10*6 TCID50
11246165|NCT02525055|OG004|Outcome|Infectious Titre 5 (18 to 45 Years Old)|Participants aged 18 to 45 received 1mL containing 3.5 x 10*5 TCID50
11246166|NCT02525055|OG005|Outcome|Infectious Titre 5 (46 to 64 Years Old)|Participants aged 46 to 64 received 1mL containing 3.5 x 10*5 TCID50
11246167|NCT02525055|EG000|Reported Event|Infectious Titre 1|"Infectious titre 1:~6 participants aged 18 to 45 were inoculated with 1mL containing 2.8 x 10*3 TCID50~Infectious titre 1: 2.8 x 10*3 TCID50/mL"
11246168|NCT02525055|EG001|Reported Event|Infectious Titre 2|"Infectious titre 2:~6 participants aged 18 to 45 were inoculated with 1mL containing 2.5 x 10*4 TCID50~Infectious titre 2: 2.5 x 10*4 TCID50/mL"
11246169|NCT02525055|EG002|Reported Event|Infectious Titre 3|"Infectious titre 3:~6 participants aged 18 to 45 were inoculated with 1mL containing 3.6 x 10*5 TCID50~Infectious titre 3: 3.6 x 10*5 TCID50/mL"
11246170|NCT02525055|EG003|Reported Event|Infectious Titre 4|"Infectious titre 4:~6 participants aged 18 to 45 were inoculated with 1mL containing 4.7 x 10*6 TCID50~Infectious titre 4: 4.7 x 10*6 TCID50/mL"
11246171|NCT02525055|EG004|Reported Event|Infectious Titre 5 (Aged 18 to 45)|"6 participants aged 18 to 45 were inoculated with 1mL containing 3.5 x 10*5 TCID50~Infectious titre 5: 3.5 x 10*5 TCID50/mL"
11246172|NCT02525055|EG005|Reported Event|Infectious Titre 5 (Aged 45 to 64)|"16 participants aged 46 to 64 were inoculated with 1mL containing 3.5 x 10*5 TCID50~Infectious titre 5: 3.5 x 10*5 TCID50/mL"
11246173|NCT02525094|BG000|Baseline|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246174|NCT02525094|BG001|Baseline|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246175|NCT02525094|BG002|Baseline|Total|Total of all reporting groups
11246176|NCT02525094|FG000|Participant Flow|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246177|NCT02525094|FG001|Participant Flow|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246178|NCT02525094|OG000|Outcome|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246179|NCT02525094|OG001|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246180|NCT02525094|OG000|Outcome|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246181|NCT02525094|EG000|Reported Event|Placebo|Participants received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246182|NCT02525094|EG001|Reported Event|MEDI9929 280 mg|Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22.
11246183|NCT02525133|BG000|Baseline|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246184|NCT02525133|BG001|Baseline|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246185|NCT02525133|BG002|Baseline|Total|Total of all reporting groups
11246186|NCT02525133|FG000|Participant Flow|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246187|NCT02525133|FG001|Participant Flow|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246188|NCT02525133|OG000|Outcome|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246189|NCT02525133|OG001|Outcome|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246190|NCT02525133|EG000|Reported Event|XaraColl|"3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose~XaraColl: Surgical implantation of 3 bupivacaine collagen implants"
11246191|NCT02525133|EG001|Reported Event|Placebo|"3 placebo implants~Placebo: Plain collagen implant (vehicle)"
11246192|NCT02525263|BG000|Baseline|NKA Augment Second Dose|This trial was a single-dose, single-arm, open-label trial. The only treatment arm was a percutaneous injection of NKA.
11246193|NCT02525263|FG000|Participant Flow|NKA Augment Second Dose|This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
11246194|NCT02525263|OG000|Outcome|NKA Augment Second Dose|This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
11246195|NCT02525263|OG000|Outcome|Neo-Kidney Augment|NKA was made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.
11246196|NCT02525263|OG000|Outcome|Neo-Kidney Augment|"NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.~Neo-Kidney Augment: NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use."
11246197|NCT02525263|EG000|Reported Event|NKA Augment Second Dose|This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
11246198|NCT02525471|BG000|Baseline|RNS60|RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 24 weeks.
11246199|NCT02525471|FG000|Participant Flow|RNS60|RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 24 weeks.
11246200|NCT02525471|OG000|Outcome|RNS60|RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 24 weeks.
11246201|NCT02525471|OG000|Outcome|RNS60|RNS60: RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 24 weeks.
11246202|NCT02525471|EG000|Reported Event|RNS60|RNS60: RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 28 weeks.
11246203|NCT02525523|BG000|Baseline|Alicaforsen|"Alicaforsen enema, 240mg once daily for 6 weeks~Alicaforsen"
11246204|NCT02525523|BG001|Baseline|Placebo|"Placebo enema, once daily for 6 weeks~Placebo"
11246205|NCT02525523|BG002|Baseline|Total|Total of all reporting groups
11246206|NCT02525523|FG000|Participant Flow|Alicaforsen|"Alicaforsen enema, 240mg once daily for 6 weeks~Alicaforsen"
11246207|NCT02525523|FG001|Participant Flow|Placebo|"Placebo enema, once daily for 6 weeks~Placebo"
11246208|NCT02525523|OG000|Outcome|Alicaforsen|"Alicaforsen enema, 240mg once daily for 6 weeks~Alicaforsen"
11246209|NCT02525523|OG001|Outcome|Placebo|"Placebo enema, once daily for 6 weeks~Placebo"
11246210|NCT02525523|EG000|Reported Event|Alicaforsen|"Alicaforsen enema, 240mg once daily for 6 weeks~Alicaforsen"
11246211|NCT02525523|EG001|Reported Event|Placebo|"Placebo enema, once daily for 6 weeks~Placebo"
11246212|NCT02525536|BG000|Baseline|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246213|NCT02525536|BG001|Baseline|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246214|NCT02525536|BG002|Baseline|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246215|NCT02525536|BG003|Baseline|Total|Total of all reporting groups
11246216|NCT02525536|FG000|Participant Flow|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246217|NCT02525536|FG001|Participant Flow|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246218|NCT02525536|FG002|Participant Flow|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246219|NCT02525536|OG000|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246220|NCT02525536|OG001|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246221|NCT02525536|OG002|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246222|NCT02525536|EG000|Reported Event|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246223|NCT02525536|EG001|Reported Event|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246224|NCT02525536|EG002|Reported Event|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11246225|NCT02525549|BG000|Baseline|Test Product|"Adapalene and Benzoyl Peroxide Gel~Adapalene and Benzoyl Peroxide Gel"
11246226|NCT02525549|BG001|Baseline|Reference Product|"Adapalene and Benzoyl Peroxide Gel (Reference)~Adapalene and Benzoyl Peroxide Gel (Reference)"
11246227|NCT02525549|BG002|Baseline|Placebo Product|"Placebo gel~Placebo gel"
11246228|NCT02525549|BG003|Baseline|Total|Total of all reporting groups
11246229|NCT02525549|FG000|Participant Flow|Test Product|"Adapalene and Benzoyl Peroxide Gel~Adapalene and Benzoyl Peroxide Gel"
11246230|NCT02525549|FG001|Participant Flow|Reference Product|"Adapalene and Benzoyl Peroxide Gel (Reference)~Adapalene and Benzoyl Peroxide Gel (Reference)"
11246231|NCT02525549|FG002|Participant Flow|Placebo Product|"Placebo gel~Placebo gel"
11246232|NCT02525549|OG000|Outcome|Test Product|"Adapalene and Benzoyl Peroxide Gel~Adapalene and Benzoyl Peroxide Gel"
11246233|NCT02525549|OG001|Outcome|Reference Product|"Adapalene and Benzoyl Peroxide Gel (Reference)~Adapalene and Benzoyl Peroxide Gel (Reference)"
11246234|NCT02525549|OG002|Outcome|Placebo Product|"Placebo gel~Placebo gel"
11246235|NCT02525549|EG000|Reported Event|Test Product|"Adapalene and Benzoyl Peroxide Gel~Adapalene and Benzoyl Peroxide Gel"
11246236|NCT02525549|EG001|Reported Event|Reference Product|"Adapalene and Benzoyl Peroxide Gel (Reference)~Adapalene and Benzoyl Peroxide Gel (Reference)"
11246237|NCT02525549|EG002|Reported Event|Placebo Product|"Placebo gel~Placebo gel"
11246238|NCT02525575|BG000|Baseline|Project Life Force Group Treatment|"A manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as high-risk. This is an open-label pilot study. All participants received the intervention."
11246239|NCT02525575|FG000|Participant Flow|Project Life Force Group Treatment|"A manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as high-risk. This is an open-label pilot study. All participants received the intervention."
11246240|NCT02525575|OG000|Outcome|Project Life Force Group Treatment|"A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as high-risk. Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care."
11246241|NCT02525575|EG000|Reported Event|Project Life Force Group Treatment|"A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as high-risk. Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care."
11246242|NCT02525588|BG000|Baseline|N2Vac Polyethylene Inlay|"Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246243|NCT02525588|BG001|Baseline|X3 Highly Cross-linked Polyethylene|"X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246244|NCT02525588|BG002|Baseline|Total|Total of all reporting groups
11246245|NCT02525588|FG000|Participant Flow|N2Vac Polyethylene Inlay|"Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246246|NCT02525588|FG001|Participant Flow|X3 Highly Cross-linked Polyethylene|"X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246247|NCT02525588|OG000|Outcome|N2Vac Polyethylene Inlay|"Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246248|NCT02525588|OG001|Outcome|X3 Highly Cross-linked Polyethylene|"X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246249|NCT02525588|EG000|Reported Event|N2Vac Polyethylene Inlay|"Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246250|NCT02525588|EG001|Reported Event|X3 Highly Cross-linked Polyethylene|"X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis~Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee."
11246251|NCT02525627|BG000|Baseline|Trident Cup, X3 Inserts, 28 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 28 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246252|NCT02525627|BG001|Baseline|Trident Cup, X3 Inserts, 40 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 40 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246253|NCT02525627|BG002|Baseline|Total|Total of all reporting groups
11246254|NCT02525627|FG000|Participant Flow|Trident Cup, X3 Inserts, 28 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 28 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246255|NCT02525627|FG001|Participant Flow|Trident Cup, X3 Inserts, 40 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 40 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246256|NCT02525627|OG000|Outcome|Trident Cup, X3 Inserts, 28 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 28 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246257|NCT02525627|OG001|Outcome|Trident Cup, X3 Inserts, 40 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 40 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246258|NCT02525627|EG000|Reported Event|Trident Cup, X3 Inserts, 28 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 28 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246259|NCT02525627|EG001|Reported Event|Trident Cup, X3 Inserts, 40 mm Head|"Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.~Trident cup, X3 inserts, 40 mm head: Orthopaedic implant~Symax stem: Orthopaedic implant~Accolade TMZF stem: Orthopaedic implant"
11246260|NCT02525653|BG000|Baseline|Albumin-Bound Paclitaxel and Gemcitabine|During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
11246261|NCT02525653|FG000|Participant Flow|Albumin-Bound Paclitaxel and Gemcitabine|During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
11246262|NCT02525653|OG000|Outcome|Albumin-Bound Paclitaxel and Gemcitabine|During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
11246263|NCT02525653|EG000|Reported Event|Albumin-Bound Paclitaxel and Gemcitabine|During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
11246264|NCT02525718|BG000|Baseline|Placebo|"Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)"
11246265|NCT02525718|BG001|Baseline|0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone|"Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.~Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.~(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
11246266|NCT02525718|BG002|Baseline|Total|Total of all reporting groups
11246267|NCT02525718|FG000|Participant Flow|Placebo|"Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)"
11246268|NCT02525718|FG001|Participant Flow|0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone|"Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.~Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.~(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
11246269|NCT02525718|OG000|Outcome|Placebo|"Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)"
11246270|NCT02525718|OG001|Outcome|0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone|"Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.~Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.~(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
11246271|NCT02525718|EG000|Reported Event|Placebo|"Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)"
11246272|NCT02525718|EG001|Reported Event|0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone|"Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.~Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.~0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.~(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
11246273|NCT02525744|BG000|Baseline|Overall Study|All participants who received at least 1 dose of study drug.
11246274|NCT02525744|FG000|Participant Flow|Sequence 1 CBARC|"Participants receive single subcutaneous dose:~C: 30 U LY900014 B: 15 U LY900014 A: 7.5 Units (U) LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014~with 3 day washout between doses"
11246275|NCT02525744|FG001|Participant Flow|Sequence 2 ACRBA|"Participants receive single subcutaneous dose:~A: 7.5 Units (U) LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) B: 15 U LY900014 A: 7.5 Units (U) LY900014~with 3 day washout between doses"
11246276|NCT02525744|FG002|Participant Flow|Sequence 3 BRCAB|"Participants receive single subcutaneous dose:~B: 15 U LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 A: 7.5 Units (U) LY900014 B: 15 U LY900014~with 3 day washout between doses"
11246277|NCT02525744|FG003|Participant Flow|Sequence 4 RABCR|"Participants receive single subcutaneous dose:~R: 15 U insulin lispro(Reference) A: 7.5 Units (U) LY900014 B: 15 U LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference)~with 3 day washout between doses"
11246278|NCT02525744|OG000|Outcome|LY900014 7.5 U|Participants receive single subcutaneous dose of 7.5 Units (U) LY900014
11246279|NCT02525744|OG001|Outcome|LY900014 15 U|Participants receive single subcutaneous dose of 15 Units (U) LY900014
11246280|NCT02525744|OG002|Outcome|LY900014 30 U|Participants receive single subcutaneous dose of 30 U LY900014
11246281|NCT02525744|OG003|Outcome|Insulin Lispro 15 U|Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
11246282|NCT02525744|EG000|Reported Event|15 U Insulin Lispro (Reference,Humalog)|Participants received single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
11246283|NCT02525744|EG001|Reported Event|LY900014 7.5 U|Participants received single subcutaneous dose of 7.5 U LY900014
11246284|NCT02525744|EG002|Reported Event|LY900014 15 U|Participants received single subcutaneous dose of 15 U LY900014
11246285|NCT02525744|EG003|Reported Event|LY900014 30 U|Participants received single subcutaneous dose of 30 U LY900014
11246286|NCT02525861|BG000|Baseline|Cohort I: GLASSIA (High-end)|Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
11246287|NCT02525861|BG001|Baseline|Cohort II: GLASSIA (Low-end)|Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246288|NCT02525861|BG002|Baseline|Total|Total of all reporting groups
11246289|NCT02525861|FG000|Participant Flow|Cohort I: GLASSIA (High-end)|Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
11246290|NCT02525861|FG001|Participant Flow|Cohort II: GLASSIA (Low-end)|Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246291|NCT02525861|OG000|Outcome|Cohort I: GLASSIA (High-end)|Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
11246292|NCT02525861|OG001|Outcome|Cohort II: GLASSIA (Low-end)|Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246293|NCT02525861|OG000|Outcome|All GLASSIA 60 mg/kg/Week|All participants who received weekly IV infusions of GLASSIA (lot with particle loads representing the High and low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246294|NCT02525861|OG000|Outcome|All GLASSIA 60 mg/kg/Week|All participants who received weekly IV infusions of GLASSIA (lot with particle loads representing the High and low end within the normal range) at 60 mg/kg BW active A1PI protein administered at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246295|NCT02525861|EG000|Reported Event|GLASSIA (High-end)|Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within) at 60 milligrams per kilogram (mg/kg) body weight (BW) active A1PI protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
11246296|NCT02525861|EG001|Reported Event|GLASSIA (Low-end)|Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
11246297|NCT02525874|BG000|Baseline|Dimethyl Fumarate (BG00012)|Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
11246298|NCT02525874|FG000|Participant Flow|Dimethyl Fumarate (BG00012)|Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
11246299|NCT02525874|OG000|Outcome|Dimethyl Fumarate (BG00012)|Participants received 120 mg BID for the first 7 days and 240 mg BID thereafter until 96 weeks.
11246300|NCT02525874|EG000|Reported Event|Dimethyl Fumarate (BG00012)|Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.
11246301|NCT02526160|BG000|Baseline|Placebo|Placebo SC Q4W through Week 24
11246302|NCT02526160|BG001|Baseline|Burosumab|Burosumab 1 mg/kg SC Q4W
11246303|NCT02526160|BG002|Baseline|Total|Total of all reporting groups
11246304|NCT02526160|FG000|Participant Flow|Placebo|Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).
11246305|NCT02526160|FG001|Participant Flow|Burosumab 1 mg/kg|SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).
11246306|NCT02526160|OG000|Outcome|Placebo|Placebo SC Q4W through Week 24
11246307|NCT02526160|OG001|Outcome|Burosumab|Burosumab 1 mg/kg SC Q4W
11246308|NCT02526160|OG000|Outcome|Placebo|Subcutaneous (SC) injection of placebo every 4 weeks (Q4W) for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).
11246309|NCT02526160|OG001|Outcome|Burosumab 1 mg/kg|SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II).
11246310|NCT02526160|OG000|Outcome|Placebo|SC injection of placebo Q4W for 24 weeks (Double-blind Placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (Open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (Open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (Open-label Treatment Extension Period II).
11246311|NCT02526160|EG000|Reported Event|Placebo (DB Period)|SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period)
11246312|NCT02526160|EG001|Reported Event|Placebo -> Burosumab (OL Period)|SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II [US only]).
11246313|NCT02526160|EG002|Reported Event|Burosumab -> Burosumab (Combined DB and OL Period)|SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II [US only]).
11246314|NCT02526160|EG003|Reported Event|Total Burosumab (Combined DB and OL Period)|SC injection of 1.0 mg/kg burosumab at any time during the study.
11246315|NCT02526212|BG000|Baseline|G-BMT, Buprenorphine|"This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246316|NCT02526212|BG001|Baseline|Treatment as Usual, Buprenorphine|"Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246317|NCT02526212|BG002|Baseline|Total|Total of all reporting groups
11246318|NCT02526212|FG000|Participant Flow|G-BMT, Buprenorphine|"This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246319|NCT02526212|FG001|Participant Flow|Treatment as Usual, Buprenorphine|"Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246320|NCT02526212|OG000|Outcome|G-BMT, Buprenorphine|"This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11213357|NCT02286102|EG000|Reported Event|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.~OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213358|NCT02286102|EG001|Reported Event|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.~Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
11213359|NCT02286193|BG000|Baseline|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
11213360|NCT02286193|FG000|Participant Flow|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
11213361|NCT02286193|OG000|Outcome|Patients Presenting to Community Liaison|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
11213362|NCT02286193|OG000|Outcome|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
11213363|NCT02286193|EG000|Reported Event|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
11213364|NCT02286466|BG000|Baseline|CBT Mobile Application|"The presence and usage of a CBT Mobile Application.~CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests."
11213365|NCT02286466|BG001|Baseline|Health Education Program|"The presence and usage of Health Education Program.~Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment."
11213366|NCT02286466|BG002|Baseline|Total|Total of all reporting groups
11213367|NCT02286466|FG000|Participant Flow|CBT Mobile Application|"The presence and usage of a CBT Mobile Application.~CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests."
11213368|NCT02286466|FG001|Participant Flow|Health Education Program|"The presence and usage of Health Education Program.~Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment."
11213369|NCT02286466|OG000|Outcome|CBT Mobile Application|"The presence and usage of a CBT Mobile Application.~CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests."
11213370|NCT02286466|OG001|Outcome|Health Education Program|"The presence and usage of Health Education Program.~Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment."
11246321|NCT02526212|OG001|Outcome|Treatment as Usual, Buprenorphine|"Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246322|NCT02526212|EG000|Reported Event|G-BMT, Buprenorphine|"This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246323|NCT02526212|EG001|Reported Event|Treatment as Usual, Buprenorphine|"Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.~Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone"
11246324|NCT02526277|BG000|Baseline|MMF07 Foot Massager Device|"Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.~MMF07 Foot Massager"
11246325|NCT02526277|BG001|Baseline|Heat Therapy|"Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.~Heat Therapy"
11246326|NCT02526277|BG002|Baseline|MMF07 Foot Massager Device and Heat Therapy|"Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.~MMF07 Foot Massager~Heat Therapy"
11246327|NCT02526277|BG003|Baseline|No Treatment|Participants receiving no intervention will be asked to not alter their nighttime routine.
11246328|NCT02526277|BG004|Baseline|Total|Total of all reporting groups
11246329|NCT02526277|FG000|Participant Flow|MMF07 Foot Massager Device|"Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.~MMF07 Foot Massager"
11246330|NCT02526277|FG001|Participant Flow|Heat Therapy|"Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.~Heat Therapy"
11246331|NCT02526277|FG002|Participant Flow|MMF07 Foot Massager Device and Heat Therapy|"Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.~MMF07 Foot Massager~Heat Therapy"
11246332|NCT02526277|FG003|Participant Flow|No Treatment|Participants receiving no intervention will be asked to not alter their nighttime routine.
11246333|NCT02526277|OG000|Outcome|Heat Therapy|"Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.~Heat Therapy"
10969657|NCT00906945|EG002|Reported Event|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11246334|NCT02526277|OG001|Outcome|MMF07 Foot Massager Device|"Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.~MMF07 Foot Massager"
10969658|NCT00906945|EG003|Reported Event|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11246335|NCT02526277|OG002|Outcome|MMF07 Foot Massager Device and Heat Therapy|"Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.~MMF07 Foot Massager~Heat Therapy"
11246336|NCT02526277|OG003|Outcome|No Treatment|Participants who received no intervention
11246337|NCT02526277|OG000|Outcome|MMF07 Foot Massager Device|"Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.~MMF07 Foot Massager"
11246338|NCT02526277|OG001|Outcome|Heat Therapy|"Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.~Heat Therapy"
11246339|NCT02526277|OG003|Outcome|No Treatment|Participants received no intervention
11246340|NCT02526277|EG000|Reported Event|MMF07 Foot Massager Device|"Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.~MMF07 Foot Massager"
11246341|NCT02526277|EG001|Reported Event|Heat Therapy|"Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.~Heat Therapy"
11246342|NCT02526277|EG002|Reported Event|MMF07 Foot Massager Device and Heat Therapy|"Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.~MMF07 Foot Massager~Heat Therapy"
11246343|NCT02526277|EG003|Reported Event|No Treatment|Participants receiving no intervention will be asked to not alter their nighttime routine.
11246344|NCT02526290|BG000|Baseline|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
11246345|NCT02526290|FG000|Participant Flow|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
11246346|NCT02526290|OG000|Outcome|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
11246347|NCT02526290|EG000|Reported Event|Active - Device|The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
11246348|NCT02526524|BG000|Baseline|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246349|NCT02526524|BG001|Baseline|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246350|NCT02526524|BG002|Baseline|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246351|NCT02526524|BG003|Baseline|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246352|NCT02526524|BG004|Baseline|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
11246353|NCT02526524|BG005|Baseline|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
11246354|NCT02526524|BG006|Baseline|Total|Total of all reporting groups
11246355|NCT02526524|FG000|Participant Flow|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246356|NCT02526524|FG001|Participant Flow|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246357|NCT02526524|FG002|Participant Flow|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246358|NCT02526524|FG003|Participant Flow|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246359|NCT02526524|FG004|Participant Flow|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
11246360|NCT02526524|FG005|Participant Flow|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
11246361|NCT02526524|OG000|Outcome|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246362|NCT02526524|OG001|Outcome|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246363|NCT02526524|OG002|Outcome|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246364|NCT02526524|OG003|Outcome|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246365|NCT02526524|OG004|Outcome|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
11246366|NCT02526524|OG005|Outcome|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
11246367|NCT02526524|EG000|Reported Event|600 mg Met DR qAM|"600 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246368|NCT02526524|EG001|Reported Event|900 mg Met DR qAM|"900 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246369|NCT02526524|EG002|Reported Event|1200 mg Met DR qAM|"1200 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246370|NCT02526524|EG003|Reported Event|1500 mg Met DR qAM|"1500 mg metformin delayed-release once daily in the morning~Met DR: metformin delayed-release tablets"
11246371|NCT02526524|EG004|Reported Event|Placebo|"placebo match for 600 and 1200 mg Met DR qAM treatment groups (Placebo 1) and placebo match for 900 and 1500 mg Met DR qAM treatment groups (Placebo 2)~Placebo"
11246372|NCT02526524|EG005|Reported Event|2000 mg Met IR|"1000 mg metformin immediate-release twice daily~Met IR: metformin immediate-release tablets"
11286295|NCT02886234|FG001|Participant Flow|Health Coaching (HC)|"Eight, 30-minute phone delivered HC sessions once a week for 8 weeks~Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics"
11246373|NCT02526550|BG000|Baseline|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
11246374|NCT02526550|FG000|Participant Flow|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
11246375|NCT02526550|OG000|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
11246376|NCT02526550|EG000|Reported Event|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
11246377|NCT02526654|BG000|Baseline|Glaucoma Subjects|Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes from the Glaucoma Service at Wills Eye Hospital in Philadelphia, Pennsylvania. They will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
11246378|NCT02526654|BG001|Baseline|Healthy Controls|Healthy control subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field from staff, family and friends of the Glaucoma Service at Wills Eye Hospital in Philadelphia, Pennsylvania. Optical Coherence Tomography will image the retinal nerve fiber layer.
11246379|NCT02526654|BG002|Baseline|Total|Total of all reporting groups
11246380|NCT02526654|FG000|Participant Flow|Glaucoma Subjects|Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes.
11246381|NCT02526654|FG001|Participant Flow|Healthy Controls|Healthy subjects that do not have glaucoma and have no other eye diseases.
11246382|NCT02526654|OG000|Outcome|Glaucoma Subjects|79 glaucoma subjects defined by characteristic glaucomatous disc damage and visual field changes
11246383|NCT02526654|OG001|Outcome|Healthy Controls|36 healthy control subjects with no glaucoma or other eye diseases.
11246384|NCT02526654|OG000|Outcome|Glaucoma Subjects|36 eyes from 30 glaucoma patients were analyzed.
11246385|NCT02526654|OG001|Outcome|Healthy Controls|59 eyes from 30 healthy controls were analyzed.
11246386|NCT02526654|OG000|Outcome|Glaucoma Subjects|53 eyes from 45 subjects with glaucoma characterized by glaucomatous disc and visual field damage.
11246387|NCT02526654|EG000|Reported Event|Glaucoma Subjects|Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes.
11246388|NCT02526654|EG001|Reported Event|Healthy Controls|Healthy control subjects that do not have glaucoma or other eye diseases.
11246389|NCT02526667|BG000|Baseline|CHG, Vehicle, Comparator CHG|Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.
11246390|NCT02526667|FG000|Participant Flow|CHG Cloth|CHG, 3 min application
11246391|NCT02526667|FG001|Participant Flow|Vehicle|Vehicle 3 min application
11246392|NCT02526667|FG002|Participant Flow|Comparator CHG|CHG comparator application
11246393|NCT02526667|OG000|Outcome|CHG 3 Min Abdomen|single application on abdomen
11246394|NCT02526667|OG001|Outcome|CHG 3 Min Groin|single application on groin
11246395|NCT02526667|OG002|Outcome|Vehicle Abdomen|single application on abdomen
11246396|NCT02526667|OG003|Outcome|Vehicle Groin|single application on groin
11246397|NCT02526667|OG004|Outcome|Comparator CHG Abdomen|single application on abdomen
11246398|NCT02526667|OG005|Outcome|Comparator CHG Groin|single application on groin
11246399|NCT02526667|EG000|Reported Event|CHG Cloth Abdomen|CHG, 3 min application to abdomen
11246400|NCT02526667|EG001|Reported Event|Vehicle Abdomen|Vehicle 3 min application to abdomen
11246401|NCT02526667|EG002|Reported Event|Comparator CHG Abdomen|CHG comparator applied to abdomen
11246402|NCT02526667|EG003|Reported Event|CHG Cloth Groin|CHG, 3 min application to groin
11246403|NCT02526667|EG004|Reported Event|Vehicle Groin|Vehicle 3 min application to groin
11246404|NCT02526667|EG005|Reported Event|Comparator CHG Groin|CHG comparator applied to groin
11246405|NCT02526680|BG000|Baseline|Glaucoma Subjects|27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month.
11246406|NCT02526680|FG000|Participant Flow|Glaucoma Subjects|27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month.
11246407|NCT02526680|OG000|Outcome|Glaucoma Subjects|27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month after using the device to measure improvement in perceived vision-related quality of life.
11246408|NCT02526680|OG000|Outcome|Glaucoma Subjects|27 glaucoma subjects were given the OrCam low vision aid device to use for 1 month.
11246409|NCT02526680|EG000|Reported Event|Glaucoma Subjects|27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month.
11246410|NCT02526693|BG000|Baseline|Glaucoma|"Glaucoma patients are recruited from Wills Eye Hospital glaucoma service, who will be tested with the RAPDx Pupillography machine.~RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light."
11246411|NCT02526693|BG001|Baseline|Healthy Control|"Healthy subjects are recruited from Wills Eye Hospital primary care service, who will be tested with the RAPDx Pupillography machine.~RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light."
11246412|NCT02526693|BG002|Baseline|Total|Total of all reporting groups
11246413|NCT02526693|FG000|Participant Flow|Glaucoma Patients|"50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer machine.~RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light."
11246414|NCT02526693|FG001|Participant Flow|Healthy Controls|"50 Healthy subjects with no eye diseases from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with RAPDx Pupillometer machine.~RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light."
11246415|NCT02526693|OG000|Outcome|Glaucoma Patients|"Glaucoma patients recruited from Glaucoma Service at Wills Eye Hospital will be tested with RAPDx Pupillography machine~Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246416|NCT02526693|OG001|Outcome|Healthy Controls|"Healthy subjects are recruited from the Wills Eye clinic, who will be tested with the RAPDx Pupillography machine~Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246417|NCT02526693|OG000|Outcome|Glaucoma|"50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer.~RAPDx Pupillometer: The Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246418|NCT02526693|OG001|Outcome|Healthy Controls|"50 Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer.~Pupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246419|NCT02526693|OG000|Outcome|Glaucoma Patients|"50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with relative afferent pupillary defect (RAPDx) Pupillometer.~Pupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246420|NCT02526693|OG001|Outcome|Healthy Controls|"50 Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with relative afferent pupillary defect (RAPDx) Pupillometer.~Pupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence."
11246421|NCT02526693|EG000|Reported Event|Glaucoma Patients|"50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service were tested with RAPDx Pupillometer.~Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light."
11246422|NCT02526693|EG001|Reported Event|Healthy Controls|"50 Healthy controls recruited from Wills Eye Hospital Glaucoma Service staff, family and friends were tested with RAPDx Pupillometer.~Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light."
11246423|NCT02527148|BG000|Baseline|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
11246424|NCT02527148|BG001|Baseline|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
11246425|NCT02527148|BG002|Baseline|Total|Total of all reporting groups
11246426|NCT02527148|FG000|Participant Flow|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
11246427|NCT02527148|FG001|Participant Flow|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
11246428|NCT02527148|OG000|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
11246429|NCT02527148|OG001|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
11246430|NCT02527148|OG000|Outcome|OtisMed® ShapeMatch® With Triathlon|"Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment).~OtisMed® ShapeMatch® Technology: The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology~Total Knee Replacement~Stryker Triathlon® Total Knee System: Prosthetic components to be implanted including~Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;~Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;~Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon."
11246431|NCT02527148|OG001|Outcome|Stryker Precision Knee Navigation|"Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group.~Stryker Precision Knee Navigation: Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol."
11246432|NCT02527148|EG000|Reported Event|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
11246433|NCT02527148|EG001|Reported Event|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
11246434|NCT02527161|BG000|Baseline|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
11246435|NCT02527161|FG000|Participant Flow|ShapeMatch® Cutting Guides With Triathlon®|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
11246436|NCT02527161|OG000|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
11246437|NCT02527161|OG000|Outcome|ShapeMatch Cutting Guides With Triathlon|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only.~ShapeMatch Cutting Guides with Triathlon: All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site."
11246438|NCT02527161|EG000|Reported Event|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
11246439|NCT02527265|BG000|Baseline|Afrezza Cohort 1 (Ages 13-17)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive daily injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246440|NCT02527265|BG001|Baseline|Afrezza Cohort 2 (Ages 8-12)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive daily injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246441|NCT02527265|BG002|Baseline|Total|Total of all reporting groups
11246442|NCT02527265|FG000|Participant Flow|Afrezza Cohort 1 (Ages 13-17)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive daily injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246443|NCT02527265|FG001|Participant Flow|Afrezza Cohort 2 (Ages 8-12)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive daily injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246444|NCT02527265|OG000|Outcome|Afrezza Cohort 1 (Ages 13-17)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246445|NCT02527265|OG001|Outcome|Afrezza Cohort 2 (Ages 8-12)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246446|NCT02527265|EG000|Reported Event|Afrezza Cohort 1 (Ages 13-17)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246447|NCT02527265|EG001|Reported Event|Afrezza Cohort 2 (Ages 8-12)|"Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days.~During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.~Afrezza: Pharmaceutical form: powder~Route of administration: inhalation"
11246448|NCT02527343|BG000|Baseline|Randomized Treatment Period: Placebo|Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
11246449|NCT02527343|BG001|Baseline|Randomized Treatment Period: Volanesorsen|Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
11246450|NCT02527343|BG002|Baseline|Total|Total of all reporting groups
11246451|NCT02527343|FG000|Participant Flow|Randomized Treatment Period: Placebo|Participants received volanesorsen-matching placebo as a subcutaneous (SC) injection once-weekly from Weeks 1 to 52 of the randomized treatment (RT) period. Participants were allowed dose adjustment based on monitoring rules.
11246452|NCT02527343|FG001|Participant Flow|Randomized Treatment Period: Volanesorsen|Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246453|NCT02527343|FG002|Participant Flow|Randomized Post-Treatment Follow-up Period: Placebo|Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period.
11246454|NCT02527343|FG003|Participant Flow|Randomized Post-Treatment Follow-up Period: Volanesorsen|Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
11246455|NCT02527343|FG004|Participant Flow|Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen|Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
11246456|NCT02527343|FG005|Participant Flow|Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen|Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
11246457|NCT02527343|OG000|Outcome|Randomized Treatment Period: Placebo|Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246458|NCT02527343|OG001|Outcome|Randomized Treatment Period: Volanesorsen|Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246459|NCT02527343|OG000|Outcome|Open-Label Extension Period: Placebo/Volanesorsen|Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
11246460|NCT02527343|OG001|Outcome|Open-Label Extension Period: Volanesorsen/Volanesorsen|Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
11246461|NCT02527343|OG000|Outcome|Randomized Treatment Period: Placebo|Participants received volanesorsen-matching placebo as a SC injection once weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246462|NCT02527343|OG001|Outcome|Randomized Treatment Period: Volanesorsen|Participants received 300 mg of volanesorsen as a SC injection once weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246463|NCT02527343|OG001|Outcome|Open-Label Extension: Volanesorsen/Volanesorsen|Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
11246464|NCT02527343|EG000|Reported Event|Randomized Treatment Period: Placebo|Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246465|NCT02527343|EG001|Reported Event|Randomized Treatment Period: Volanesorsen|Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
11246466|NCT02527343|EG002|Reported Event|Randomized Post-Treatment Follow-up: Placebo|Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the OLE period went straight to the 13-week post-treatment follow-up period.
11246467|NCT02527343|EG003|Reported Event|Randomized Post-Treatment Follow-up: Volanesorsen|Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
11246468|NCT02527343|EG004|Reported Event|Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen|Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
11246469|NCT02527343|EG005|Reported Event|Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen|Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
11246470|NCT02527421|BG000|Baseline|DFD01 Spray Group 1|"DFD01 spray, twice daily, 15 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246471|NCT02527421|BG001|Baseline|DFD01 Spray Group 2|"DFD01 spray, twice daily, 29 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246472|NCT02527421|BG002|Baseline|Total|Total of all reporting groups
10820158|NCT00054353|EG000|Reported Event|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s"
10820159|NCT00054353|EG001|Reported Event|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s"
11246473|NCT02527421|FG000|Participant Flow|DFD01 Spray Group 1|"DFD01 spray, twice daily, 15 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246474|NCT02527421|FG001|Participant Flow|DFD01 Spray Group 2|"DFD01 spray, twice daily, 29 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246475|NCT02527421|OG000|Outcome|DFD01 Spray Group 1|"DFD01 spray, twice daily, 15 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246476|NCT02527421|OG001|Outcome|DFD01 Spray Group 2|"DFD01 spray, twice daily, 29 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246477|NCT02527421|EG000|Reported Event|DFD01 Spray Group 1|"DFD01 spray, twice daily, 15 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246478|NCT02527421|EG001|Reported Event|DFD01 Spray Group 2|"DFD01 spray, twice daily, 29 days~DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%"
11246479|NCT02527512|BG000|Baseline|Povidone-Iodine|"0.35% povidone-iodine (Betadine)~Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine"
11246480|NCT02527512|BG001|Baseline|Normal Saline|"Sterile sodium chloride (NaCl) solution~Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter"
11246481|NCT02527512|BG002|Baseline|Total|Total of all reporting groups
11246482|NCT02527512|FG000|Participant Flow|Povidone-Iodine|"0.35% povidone-iodine (Betadine)~Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine"
11246483|NCT02527512|FG001|Participant Flow|Normal Saline|"Sterile sodium chloride (NaCl) solution~Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter"
11246484|NCT02527512|OG000|Outcome|Povidone-Iodine|"0.35% povidone-iodine (Betadine)~Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine"
11246485|NCT02527512|OG001|Outcome|Normal Saline|"Sterile sodium chloride (NaCl) solution~Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter"
11246486|NCT02527512|OG000|Outcome|High Risk Povidone-iodine|congenital, neuromuscular, and syndromic deformities
11246487|NCT02527512|OG001|Outcome|High Risk Saline|congenital, neuromuscular, and syndromic deformities
11246488|NCT02527512|OG002|Outcome|Low Risk Povidone-iodine|idiopathic deformities
11246489|NCT02527512|OG003|Outcome|Low Risk Saline|idiopathic deformities
11246490|NCT02527512|EG000|Reported Event|Povidone-Iodine|"0.35% povidone-iodine (Betadine)~Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine"
11246491|NCT02527512|EG001|Reported Event|Normal Saline|"Sterile sodium chloride (NaCl) solution~Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter"
11246492|NCT02527694|BG000|Baseline|Standard Stretcher Cart Group|Standard strecher for manual compression on supine position
11246493|NCT02527694|BG001|Baseline|Flexible Stretcher Cart Group|We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.
11246494|NCT02527694|BG002|Baseline|Total|Total of all reporting groups
11246495|NCT02527694|FG000|Participant Flow|Flexible Stretcher Cart Group|"Patients in this group will be transported on the new flexible stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.~Flexible EMS stretcher cart: The flexible stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs.~mechanical CPR"
11246496|NCT02527694|FG001|Participant Flow|Standard Stretcher Cart Group|Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.
11246497|NCT02527694|OG000|Outcome|Standard Stretcher Cart Group|Standard strecher for manual compression on supine position
11246498|NCT02527694|OG001|Outcome|Flexible Stretcher Cart Group|We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.
11246499|NCT02527694|OG000|Outcome|Standard Stretcher Group|Standard strecher for manual compression on supine position
11246500|NCT02527694|OG001|Outcome|Reducible Stretcher Group|We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.
11246501|NCT02527694|EG000|Reported Event|Standard Stretcher Group|Standard strecher for manual compression on supine position
11246502|NCT02527694|EG001|Reported Event|Reducible Stretcher Group|We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.
11246503|NCT02528188|BG000|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.
11246504|NCT02528188|BG001|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.
11246505|NCT02528188|BG002|Baseline|NSAID|Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
11246506|NCT02528188|BG003|Baseline|Total|Total of all reporting groups
11246507|NCT02528188|FG000|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.
11246508|NCT02528188|FG001|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.
11246509|NCT02528188|FG002|Participant Flow|NSAID|Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
11246510|NCT02528188|OG000|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.
11246511|NCT02528188|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.
11246512|NCT02528188|OG002|Outcome|NSAID|Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
11246513|NCT02528188|EG000|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection administered subcutaneously (SC) once every 8 weeks, from Baseline (Day 1) up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac extended release (ER), twice daily, from Baseline up to Week 56.
11246514|NCT02528188|EG001|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks, from Baseline up to Week 48 and oral placebo tablets matched to naproxen, celecoxib or diclofenac ER, twice daily, from Baseline up to week 56.
11246515|NCT02528188|EG002|Reported Event|NSAID|Non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac ER 75 mg), administered orally, twice daily, from Baseline up to week 56 and placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks, from Baseline up to Week 48.
11246516|NCT02528214|BG000|Baseline|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246517|NCT02528214|BG001|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246518|NCT02528214|BG002|Baseline|Total|Total of all reporting groups
11246519|NCT02528214|FG000|Participant Flow|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246520|NCT02528214|FG001|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246521|NCT02528214|OG000|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246522|NCT02528214|OG001|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20.
11246523|NCT02528214|OG000|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until week 20.
11246524|NCT02528214|EG000|Reported Event|Placebo q2w|Participants who received Placebo (for Dupilumab) in combination with OCS and stable ICS (mean exposure of 24 weeks).
11246525|NCT02528214|EG001|Reported Event|Dupilumab 300mg q2w|Participants who received Dupilumab 300 mg q2w in combination with OCS and stable ICS (mean exposure of 24 weeks).
11246526|NCT02528253|BG000|Baseline|Placebo Followed by Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria >=30 percent [%] reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246527|NCT02528253|BG001|Baseline|Placebo Followed by Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246528|NCT02528253|BG002|Baseline|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246529|NCT02528253|BG003|Baseline|Pooled Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246530|NCT02528253|BG004|Baseline|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11246531|NCT02528253|BG005|Baseline|Total|Total of all reporting groups
11246532|NCT02528253|FG000|Participant Flow|Placebo Followed by Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously (SC) once every 8 weeks and placebo tablets matched to tramadol prolonged release (PR), orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria (greater than equal to [>=] 30 percent [%] reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246533|NCT02528253|FG001|Participant Flow|Placebo Followed by Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246534|NCT02528253|FG002|Participant Flow|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246535|NCT02528253|FG003|Participant Flow|Pooled Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246536|NCT02528253|FG004|Participant Flow|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11246537|NCT02528253|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to Week 16. At Week 16, participants who met efficacy responder criteria (30 percent % reduction in average (LBPI) score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246538|NCT02528253|OG001|Outcome|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246539|NCT02528253|OG002|Outcome|Pooled Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246540|NCT02528253|OG003|Outcome|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11246541|NCT02528253|OG000|Outcome|Placebo Followed by Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria >=30 percent [%] reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 milligram (mg), SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246542|NCT02528253|OG001|Outcome|Placebo Followed by Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 (baseline) up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246543|NCT02528253|OG002|Outcome|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246544|NCT02528253|OG003|Outcome|Pooled Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246545|NCT02528253|OG004|Outcome|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11246546|NCT02528253|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 percentage % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily from week 16 to week 56.
11246547|NCT02528253|OG001|Outcome|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246548|NCT02528253|OG000|Outcome|Pooled Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246549|NCT02528253|OG001|Outcome|Pooled Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246550|NCT02528253|OG002|Outcome|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11246551|NCT02528253|OG001|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16.
11246552|NCT02528253|OG002|Outcome|Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16.
11246553|NCT02528253|OG000|Outcome|Placebo (Week 16)|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16, inclusive of those participants who were randomized to placebo but received tramadol.
11246554|NCT02528253|OG001|Outcome|Safety Evaluation: Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246555|NCT02528253|OG002|Outcome|Safety Evaluation: Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria, then received tanezumab 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246556|NCT02528253|OG000|Outcome|Safety Evaluation: Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246557|NCT02528253|OG001|Outcome|Safety Evaluation: Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246558|NCT02528253|OG001|Outcome|Safety Evaluation: Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246559|NCT02528253|OG002|Outcome|Safety Evaluation: Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246560|NCT02528253|OG001|Outcome|Safety Evaluation: Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246561|NCT02528253|OG002|Outcome|Safety Evaluation: Tanezumab 10 mg|Tanezumab (RN624 or PF-04383119) 10 mg injection administered SC once every 8 weeks from Day 1, and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246562|NCT02528253|EG000|Reported Event|Placebo (Week 16)|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16, inclusive of those participants who were randomized to placebo but received tramadol.
11286296|NCT02886234|OG000|Outcome|Mindfulness Training (MT)|"Eight, 30-minute phone delivered MT sessions once a week for 8 weeks~Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor."
11246563|NCT02528253|EG001|Reported Event|Safety Evaluation: Tanezumab 5 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 5 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246564|NCT02528253|EG002|Reported Event|Safety Evaluation: Tanezumab 10 mg|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered SC, once every 8 weeks from Day 1 (baseline), and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 16. At week 16, participants who met efficacy responder criteria (>=30 % reduction in average LBPI score and >=15% reduction in average LBPI score relative to baseline at any week from week 1 to week 15), then received tanezumab 5 mg or 10 mg, SC, once every 8 weeks plus placebo tablets matched to tramadol PR, orally, once daily, from week 16 to week 56.Those participants were also included who received tanezumab 10 mg injection administered SC once every 8 weeks from Day 1 and placebo tablets matched to tramadol PR, orally, once daily from Day 1 up to week 56.
11246565|NCT02528253|EG003|Reported Event|Tramadol|Tramadol PR tablet of 100 mg (during baseline to week 4, dose increments by 100 mg was allowed up to a maximum of 300 mg, depending on pain relief or tolerability), once daily and placebo injection matched to tramadol, administered SC once every 8 weeks, from Day 1 up to week 56.
11286297|NCT02886234|OG001|Outcome|Health Coaching (HC)|"Eight, 30-minute phone delivered HC sessions once a week for 8 weeks~Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics"
11286298|NCT02886234|EG000|Reported Event|Mindfulness Training (MT)|"Eight, 30-minute phone delivered MT sessions once a week for 8 weeks~Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor."
11286299|NCT02886234|EG001|Reported Event|Health Coaching (HC)|"Eight, 30-minute phone delivered HC sessions once a week for 8 weeks~Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics"
11286300|NCT02886338|BG000|Baseline|Capsule Endoscopy Group|"Capsule endoscopy group: Participants swallowed a magnetic-assisted capsule endoscope, and an external magnetic field navigator is used for magnetic capsule manipulation in the upper gastrointestinal tract.~The movement of the magnetic capsule endoscope can be driven by an external magnetic field navigator. The external magnetic field navigator can also adjust the direction of movement of the capsule in the stomach and duodenum. Through the external magnetic-mediated navigation of the capsule in the upper gastrointestinal tract, clinicians can potentially examine the whole upper gastrointestinal tract."
11286301|NCT02886338|FG000|Participant Flow|Capsule Endoscopy Group|"The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible.~capsule endoscopy: The magnetic navigated capsule endoscope would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract."
11286302|NCT02886338|OG000|Outcome|Capsule Endoscopy Group|"Capsule endoscopy group: Participants swallowed a magnetic-assisted capsule endoscope, and an external magnetic field navigator is used for magnetic capsule manipulation in the upper gastrointestinal tract.~The movement of the magnetic capsule endoscope can be driven by an external magnetic field navigator. The external magnetic field navigator can also adjust the direction of movement of the capsule in the stomach and duodenum. Through the external magnetic-mediated navigation of the capsule in the upper gastrointestinal tract, clinicians can potentially examine the whole upper gastrointestinal tract."
11286303|NCT02886338|EG000|Reported Event|Healthy Subjects With Capsule Endoscopy Examination|"We included participants who were aged from 20 to 65 years. Exclude from the study were those (A) who had obstruction of the GI tract; (B) were pregnant; (C) had pacemaker implantation; (D) were implanted with metal or electronic devices, artificial joints or fixators (E) had cancer; (F) had difficulty in swallowing; (G) had a history of stomach operation.~All participants received the capsule endoscopic examination for the esophagus, stomach and duodenum."
11286304|NCT02886494|BG000|Baseline|BAC Treatment|"BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.~Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle"
11286305|NCT02886494|BG001|Baseline|Matched Vehicle|BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286306|NCT02886494|BG002|Baseline|Total|Total of all reporting groups
11286307|NCT02886494|FG000|Participant Flow|BAC Treatment|"BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.~Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle"
11286308|NCT02886494|FG001|Participant Flow|Matched Vehicle|BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286309|NCT02886494|OG000|Outcome|BAC Treatment|BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286310|NCT02886494|OG001|Outcome|Matched Vehicle|BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286311|NCT02886494|OG000|Outcome|BAC Treatment Arm|BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11246566|NCT02528305|BG000|Baseline|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
11246567|NCT02528305|FG000|Participant Flow|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
11246568|NCT02528305|OG000|Outcome|Baseline Assessment|on entry to trial
11246569|NCT02528305|OG001|Outcome|After 6 Week Control Period|repeat assessment after 6 weeks of no intervention
11246570|NCT02528305|OG002|Outcome|After HIT Assessment|final assessment within 1 week of completing 6 weeks of HIT
11246571|NCT02528305|EG000|Reported Event|High-intensity Interval Training (HIT)|"6 week control period with no intervention then 6 weeks of twice weekly HIT~High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12."
11246572|NCT02528318|BG000|Baseline|50 mg/kg|"Lucinactant for inhalation 50 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246573|NCT02528318|BG001|Baseline|75 mg/kg|"Lucinactant for inhalation 75 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246574|NCT02528318|BG002|Baseline|100 mg/kg|"Lucinactant for inhalation 100 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246575|NCT02528318|BG003|Baseline|150 mg/kg|"Lucinactant for inhalation 150 mg TPL/kg with nCPAP~1 repeat dose will be allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246576|NCT02528318|BG004|Baseline|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
11246577|NCT02528318|BG005|Baseline|Total|Total of all reporting groups
11246578|NCT02528318|FG000|Participant Flow|50 mg/kg|"Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246579|NCT02528318|FG001|Participant Flow|75 mg/kg|"Lucinactant for inhalation 75 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246580|NCT02528318|FG002|Participant Flow|100 mg/kg|"Lucinactant for inhalation 100 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246581|NCT02528318|FG003|Participant Flow|150 mg/kg|"Lucinactant for inhalation 150 mg TPL/kg with nCPAP~1 repeat dose will be allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246582|NCT02528318|FG004|Participant Flow|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
11246583|NCT02528318|OG000|Outcome|50 mg/kg|"Lucinactant for inhalation 50 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246584|NCT02528318|OG001|Outcome|75 mg/kg|"Lucinactant for inhalation 75 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246585|NCT02528318|OG002|Outcome|100 mg/kg|"Lucinactant for inhalation 100 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246586|NCT02528318|OG003|Outcome|150 mg/kg|"Lucinactant for inhalation 150 mg TPL/kg with nCPAP~1 repeat dose will be allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246587|NCT02528318|OG004|Outcome|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
11246588|NCT02528318|EG000|Reported Event|50 mg/kg|"Lucinactant for inhalation 50 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246589|NCT02528318|EG001|Reported Event|75 mg/kg|"Lucinactant for inhalation 75 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246590|NCT02528318|EG002|Reported Event|100 mg/kg|"Lucinactant for inhalation 100 mg TPL/kg with nCPAP~1 repeat dose allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246591|NCT02528318|EG003|Reported Event|150 mg/kg|"Lucinactant for inhalation 150 mg TPL/kg with nCPAP~1 repeat dose will be allowed if repeat dosing criteria are met.~Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)"
11246592|NCT02528318|EG004|Reported Event|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
11246593|NCT02528331|BG000|Baseline|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
11246594|NCT02528331|FG000|Participant Flow|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
11246595|NCT02528331|OG000|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
11246596|NCT02528331|EG000|Reported Event|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
11246597|NCT02528357|BG000|Baseline|Part 1: GSK3174998 0.003 mg/kg|Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
11246598|NCT02528357|BG001|Baseline|Part 1: GSK3174998 0.01 mg/kg|Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
11246599|NCT02528357|BG002|Baseline|Part 1: GSK3174998 0.03 mg/kg|Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
11246600|NCT02528357|BG003|Baseline|Part 1: GSK3174998 0.1 mg/kg|Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
11246601|NCT02528357|BG004|Baseline|Part 1: GSK3174998 0.3 mg/kg|Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
11246602|NCT02528357|BG005|Baseline|Part 1: GSK3174998 1.0 mg/kg|Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
11246603|NCT02528357|BG006|Baseline|Part 1: GSK3174998 3.0 mg/kg|Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
11246604|NCT02528357|BG007|Baseline|Part 1: GSK3174998 10.0 mg/kg|Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
11246605|NCT02528357|BG008|Baseline|Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246606|NCT02528357|BG009|Baseline|Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246607|NCT02528357|BG010|Baseline|Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246608|NCT02528357|BG011|Baseline|Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246609|NCT02528357|BG012|Baseline|Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246610|NCT02528357|BG013|Baseline|Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246611|NCT02528357|BG014|Baseline|Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246612|NCT02528357|BG015|Baseline|Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246613|NCT02528357|BG016|Baseline|Part 2B: Melanoma Cohort|Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246614|NCT02528357|BG017|Baseline|Part 2B: Soft Tissue Sarcoma Cohort|Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246615|NCT02528357|BG018|Baseline|Part 2B: NSCLC Cohort|Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246616|NCT02528357|BG019|Baseline|Total|Total of all reporting groups
11246617|NCT02528357|FG000|Participant Flow|Part 1: GSK3174998 0.003 mg/kg|Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
11246618|NCT02528357|FG001|Participant Flow|Part 1: GSK3174998 0.01 mg/kg|Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
11246619|NCT02528357|FG002|Participant Flow|Part 1: GSK3174998 0.03 mg/kg|Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
11246620|NCT02528357|FG003|Participant Flow|Part 1: GSK3174998 0.1 mg/kg|Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
11246621|NCT02528357|FG004|Participant Flow|Part 1: GSK3174998 0.3 mg/kg|Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
11246622|NCT02528357|FG005|Participant Flow|Part 1: GSK3174998 1.0 mg/kg|Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
11246623|NCT02528357|FG006|Participant Flow|Part 1: GSK3174998 3.0 mg/kg|Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
11246624|NCT02528357|FG007|Participant Flow|Part 1: GSK3174998 10.0 mg/kg|Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
11246625|NCT02528357|FG008|Participant Flow|Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246626|NCT02528357|FG009|Participant Flow|Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246627|NCT02528357|FG010|Participant Flow|Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246628|NCT02528357|FG011|Participant Flow|Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246629|NCT02528357|FG012|Participant Flow|Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246630|NCT02528357|FG013|Participant Flow|Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246631|NCT02528357|FG014|Participant Flow|Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246632|NCT02528357|FG015|Participant Flow|Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246633|NCT02528357|FG016|Participant Flow|Part 2B: Melanoma Cohort|Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246634|NCT02528357|FG017|Participant Flow|Part 2B: Soft Tissue Sarcoma Cohort|Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246635|NCT02528357|FG018|Participant Flow|Part 2B: NSCLC Cohort|Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246636|NCT02528357|OG000|Outcome|Part 1: GSK3174998 0.003 mg/kg|Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
11246637|NCT02528357|OG001|Outcome|Part 1: GSK3174998 0.01 mg/kg|Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
11246638|NCT02528357|OG002|Outcome|Part 1: GSK3174998 0.03 mg/kg|Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
11246639|NCT02528357|OG003|Outcome|Part 1: GSK3174998 0.1 mg/kg|Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
11246640|NCT02528357|OG004|Outcome|Part 1: GSK3174998 0.3 mg/kg|Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
11246641|NCT02528357|OG005|Outcome|Part 1: GSK3174998 1.0 mg/kg|Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
11246642|NCT02528357|OG006|Outcome|Part 1: GSK3174998 3.0 mg/kg|Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
11246643|NCT02528357|OG007|Outcome|Part 1: GSK3174998 10.0 mg/kg|Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
11246644|NCT02528357|OG000|Outcome|Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246645|NCT02528357|OG001|Outcome|Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246646|NCT02528357|OG002|Outcome|Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246647|NCT02528357|OG003|Outcome|Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246648|NCT02528357|OG004|Outcome|Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246649|NCT02528357|OG005|Outcome|Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246650|NCT02528357|OG006|Outcome|Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246651|NCT02528357|OG007|Outcome|Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246652|NCT02528357|OG000|Outcome|Part 2B: Melanoma Cohort|Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246653|NCT02528357|OG001|Outcome|Part 2B: Soft Tissue Sarcoma Cohort|Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246654|NCT02528357|OG002|Outcome|Part 2B: NSCLC Cohort|Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246655|NCT02528357|EG000|Reported Event|Part 1: GSK3174998 0.003 mg/kg|Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
11246656|NCT02528357|EG001|Reported Event|Part 1: GSK3174998 0.01 mg/kg|Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
11246657|NCT02528357|EG002|Reported Event|Part 1: GSK3174998 0.03 mg/kg|Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
11246658|NCT02528357|EG003|Reported Event|Part 1: GSK3174998 0.1 mg/kg|Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
11246659|NCT02528357|EG004|Reported Event|Part 1: GSK3174998 0.3 mg/kg|Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
11246660|NCT02528357|EG005|Reported Event|Part 1: GSK3174998 1.0 mg/kg|Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
11246661|NCT02528357|EG006|Reported Event|Part 1: GSK3174998 3.0 mg/kg|Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
11246662|NCT02528357|EG007|Reported Event|Part 1: GSK3174998 10.0 mg/kg|Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
11246663|NCT02528357|EG008|Reported Event|Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246664|NCT02528357|EG009|Reported Event|Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246665|NCT02528357|EG010|Reported Event|Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246666|NCT02528357|EG011|Reported Event|Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246667|NCT02528357|EG012|Reported Event|Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246668|NCT02528357|EG013|Reported Event|Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246669|NCT02528357|EG014|Reported Event|Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246670|NCT02528357|EG015|Reported Event|Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg|Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
11246671|NCT02528357|EG016|Reported Event|Part 2B: Melanoma Cohort|Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246672|NCT02528357|EG017|Reported Event|Part 2B: Soft Tissue Sarcoma Cohort|Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246673|NCT02528357|EG018|Reported Event|Part 2B: NSCLC Cohort|Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
11246674|NCT02528370|BG000|Baseline|telEPOC|The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.
11246675|NCT02528370|BG001|Baseline|No telEPOC / Usual Care|"The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months.~Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control."
11246676|NCT02528370|BG002|Baseline|Total|Total of all reporting groups
11246677|NCT02528370|FG000|Participant Flow|telEPOC|The program consisted of: 1) Educational program about chronic obstructive pulmonary disease (COPD). This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.
11246678|NCT02528370|FG001|Participant Flow|No telEPOC / Usual Care|"The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months.~Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control."
11246679|NCT02528370|OG000|Outcome|telEPOC|The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.
11246680|NCT02528370|OG001|Outcome|No telEPOC / Usual Care|"The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months.~Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control."
11246681|NCT02528370|EG000|Reported Event|telEPOC|The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.
11246682|NCT02528370|EG001|Reported Event|No telEPOC / Usual Care|"The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months.~Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control."
11246683|NCT02528409|BG000|Baseline|Placebo|"10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Placebo"
11246684|NCT02528409|BG001|Baseline|Vortioxetine|"10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Vortioxetine: Medication currently approved for major depression."
11246685|NCT02528409|BG002|Baseline|Total|Total of all reporting groups
11246686|NCT02528409|FG000|Participant Flow|Placebo|"10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Placebo"
11246687|NCT02528409|FG001|Participant Flow|Vortioxetine|"10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Vortioxetine: Medication currently approved for major depression."
11213371|NCT02286466|EG000|Reported Event|CBT Mobile Application|"The presence and usage of a CBT Mobile Application.~CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests."
11213372|NCT02286466|EG001|Reported Event|Health Education Program|"The presence and usage of Health Education Program.~Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment."
11213373|NCT02286518|BG000|Baseline|Part 1 SRD-Cohort 1A - 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213374|NCT02286518|BG001|Baseline|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213375|NCT02286518|BG002|Baseline|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213376|NCT02286518|BG003|Baseline|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213377|NCT02286518|BG004|Baseline|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213378|NCT02286518|BG005|Baseline|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213379|NCT02286518|BG006|Baseline|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213380|NCT02286518|BG007|Baseline|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
11213381|NCT02286518|BG008|Baseline|Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.
11213382|NCT02286518|BG009|Baseline|Part 3 Placebo Cohort 5A - 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213383|NCT02286518|BG010|Baseline|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213384|NCT02286518|BG011|Baseline|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213385|NCT02286518|BG012|Baseline|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213386|NCT02286518|BG013|Baseline|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213387|NCT02286518|BG014|Baseline|Total|Total of all reporting groups
11213388|NCT02286518|FG000|Participant Flow|Part 1 SRD-Cohort 1A - 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213389|NCT02286518|FG001|Participant Flow|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213390|NCT02286518|FG002|Participant Flow|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213391|NCT02286518|FG003|Participant Flow|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213392|NCT02286518|FG004|Participant Flow|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213393|NCT02286518|FG005|Participant Flow|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213394|NCT02286518|FG006|Participant Flow|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213395|NCT02286518|FG007|Participant Flow|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
11213396|NCT02286518|FG008|Participant Flow|Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.
11213397|NCT02286518|FG009|Participant Flow|Part 3 Placebo Cohort 5A - 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11246688|NCT02528409|OG000|Outcome|Placebo|"10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Placebo"
11246689|NCT02528409|OG001|Outcome|Vortioxetine|"10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Vortioxetine: Medication currently approved for major depression."
11246690|NCT02528409|EG000|Reported Event|Placebo|"10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Placebo"
11246691|NCT02528409|EG001|Reported Event|Vortioxetine|"10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.~Vortioxetine: Medication currently approved for major depression."
11246692|NCT02528721|BG000|Baseline|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246693|NCT02528721|BG001|Baseline|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246694|NCT02528721|BG002|Baseline|Total|Total of all reporting groups
11246695|NCT02528721|FG000|Participant Flow|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246696|NCT02528721|FG001|Participant Flow|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
10969659|NCT00906945|EG004|Reported Event|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11246697|NCT02528721|OG000|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246698|NCT02528721|OG001|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246699|NCT02528721|EG000|Reported Event|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246700|NCT02528721|EG001|Reported Event|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
11246701|NCT02528786|BG000|Baseline|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
11246702|NCT02528786|FG000|Participant Flow|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 milliliter [mL] per sample) for DNA isolation were collected from each participant.
11246703|NCT02528786|OG000|Outcome|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
10969660|NCT00906945|EG005|Reported Event|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
11246704|NCT02528786|EG000|Reported Event|All Participants|Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
11246705|NCT02528942|BG000|Baseline|Radiation Therapy|"The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.~Radiation therapy: Radiation therapy will be given to study patients."
11246706|NCT02528942|FG000|Participant Flow|Radiation Therapy|"The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.~Radiation therapy: Radiation therapy will be given to study patients."
11246707|NCT02528942|OG000|Outcome|Radiation Therapy|"The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.~Radiation therapy: Radiation therapy will be given to study patients."
11246708|NCT02528942|EG000|Reported Event|Radiation Therapy|"The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.~Radiation therapy: Radiation therapy will be given to study patients."
11246709|NCT02529072|BG000|Baseline|Group I|Patients will receive nivolumab 3 mg/kg IV every 2 weeks for 8 weeks followed by surgery. Following resection, nivolumab and DC vaccine will be administered every 2 weeks (± 1) for a total of 3 vaccines, followed by biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246710|NCT02529072|BG001|Baseline|Group II|Patients will initially receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV and DC vaccine every 2 weeks for a total of 3 vaccines, and then surgery. Subsequent to surgery, the patient will resume biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246711|NCT02529072|BG002|Baseline|Total|Total of all reporting groups
11246712|NCT02529072|FG000|Participant Flow|Group I|Patients will receive nivolumab 3 mg/kg IV every 2 weeks for 8 weeks followed by surgery. Following resection, nivolumab and DC vaccine will be administered every 2 weeks (± 1) for a total of 3 vaccines, followed by biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246713|NCT02529072|FG001|Participant Flow|Group II|Patients will initially receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV and DC vaccine every 2 weeks for a total of 3 vaccines, and then surgery. Subsequent to surgery, the patient will resume biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246714|NCT02529072|OG000|Outcome|Group I|Patients will receive nivolumab 3 mg/kg IV every 2 weeks for 8 weeks followed by surgery. Following resection, nivolumab and DC vaccine will be administered every 2 weeks (± 1) for a total of 3 vaccines, followed by biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246715|NCT02529072|OG001|Outcome|Group II|Patients will initially receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV and DC vaccine every 2 weeks for a total of 3 vaccines, and then surgery. Subsequent to surgery, the patient will resume biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246716|NCT02529072|EG000|Reported Event|Group I|Patients will receive nivolumab 3 mg/kg IV every 2 weeks for 8 weeks followed by surgery. Following resection, nivolumab and DC vaccine will be administered every 2 weeks (± 1) for a total of 3 vaccines, followed by biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246717|NCT02529072|EG001|Reported Event|Group II|Patients will initially receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV and DC vaccine every 2 weeks for a total of 3 vaccines, and then surgery. Subsequent to surgery, the patient will resume biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.
11246718|NCT02529137|BG000|Baseline|Surgical Pathology Cases|Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
11246719|NCT02529137|FG000|Participant Flow|Surgical Pathology Cases|Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
11246720|NCT02529137|OG000|Outcome|Manual Optical (MO)|MO is defined as reading by using optical microscope. Reading results in a diagnosis. This diagnosis is later compared to the main diagnosis resulting in either concordance, minor discordance or major discordance.
11246721|NCT02529137|OG001|Outcome|Manual Digital (MD)|MD is defined as reading by using PIPS. Reading results in a diagnosis. This diagnosis is later compared to the main diagnosis resulting in either concordance, minor discordance or major discordance.
11246722|NCT02529137|EG000|Reported Event|Surgical Pathology Cases|Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
11246723|NCT02529488|BG000|Baseline|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
11246724|NCT02529488|FG000|Participant Flow|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
11246725|NCT02529488|OG000|Outcome|TFNT00 Visit 3A|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 20-40 post second eye implantation
11246726|NCT02529488|OG001|Outcome|TFNT00 Visit 4A|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 120-180 post second eye implantation
11246727|NCT02529488|EG000|Reported Event|TFNT00 - 1st Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye
11246728|NCT02529488|EG001|Reported Event|TFNT00 - 2nd Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye
11246729|NCT02529488|EG002|Reported Event|TFNT00 - Non-Study Eye|All eyes not implanted with a study lens
11246730|NCT02529488|EG003|Reported Event|TFNT00 - Systemic|All subjects with attempted test article implantation (successful or aborted after contact with the eye).
11246731|NCT02529553|BG000|Baseline|LY3076226-0.2mg/kg|Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg.
11246732|NCT02529553|BG001|Baseline|LY3076226-0.4mg/kg|Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
11246733|NCT02529553|BG002|Baseline|LY3076226-0.8mg/kg|Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
11246734|NCT02529553|BG003|Baseline|LY3076226-1.6mg/kg|Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
11246735|NCT02529553|BG004|Baseline|LY3076226-2.4mg/kg|Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
11246736|NCT02529553|BG005|Baseline|LY3076226-3.2mg/kg|Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
11246737|NCT02529553|BG006|Baseline|LY3076226-4.0mg/kg|Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
11246738|NCT02529553|BG007|Baseline|LY3076226-5.0mg/kg|Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
11246739|NCT02529553|BG008|Baseline|LY3076226-5.0mg/kg Dose Expansion|Part B dose expansion of LY3076226 at 5.0mg/kg.
11246740|NCT02529553|BG009|Baseline|Total|Total of all reporting groups
11246741|NCT02529553|FG000|Participant Flow|LY3076226-0.2mg/kg|Part A cohort 1 of dose escalation of LY3076226 at 0.2 milligram per killogram (mg/kg).
11246742|NCT02529553|FG001|Participant Flow|LY3076226-0.4mg/kg|Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
11246743|NCT02529553|FG002|Participant Flow|LY3076226-0.8mg/kg|Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
11246744|NCT02529553|FG003|Participant Flow|LY3076226-1.6mg/kg|Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
11246745|NCT02529553|FG004|Participant Flow|LY3076226-2.4mg/kg|Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
11246746|NCT02529553|FG005|Participant Flow|LY3076226-3.2mg/kg|Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
11246747|NCT02529553|FG006|Participant Flow|LY3076226-4.0mg/kg|Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
11246748|NCT02529553|FG007|Participant Flow|LY3076226-5.0mg/kg|Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
11246749|NCT02529553|FG008|Participant Flow|LY3076226-5.0mg/kg Dose Expansion|Part B dose expansion of LY3076226 at 5.0mg/kg.
11246750|NCT02529553|OG000|Outcome|LY3076226|Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
11246751|NCT02529553|OG000|Outcome|LY3076226-0.2mg/kg|Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
11246752|NCT02529553|OG001|Outcome|LY3076226-0.4mg/kg|Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
11246753|NCT02529553|OG002|Outcome|LY3076226-0.8mg/kg|Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
11246754|NCT02529553|OG003|Outcome|LY3076226-1.6mg/kg|Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
11246755|NCT02529553|OG004|Outcome|LY3076226-2.4mg/kg|Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
11246756|NCT02529553|OG005|Outcome|LY3076226-3.2mg/kg|Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
11246757|NCT02529553|OG006|Outcome|LY3076226-4.0mg/kg|Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
11246758|NCT02529553|OG007|Outcome|LY3076226-5.0mg/kg|Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
11246759|NCT02529553|OG008|Outcome|LY3076226-5.0mg/kg Dose Expansion|Dose expansion of LY3076226 at 5.0mg/kg.
11246760|NCT02529553|EG000|Reported Event|LY3076226-0.2mg/kg|Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg.
11246761|NCT02529553|EG001|Reported Event|LY3076226-0.4mg/kg|Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
11246762|NCT02529553|EG002|Reported Event|LY3076226-0.8mg/kg|Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
11246763|NCT02529553|EG003|Reported Event|LY3076226-1.6mg/kg|Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
11246764|NCT02529553|EG004|Reported Event|LY3076226-2.4mg/kg|Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
11246765|NCT02529553|EG005|Reported Event|LY3076226-3.2mg/kg|Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
11246766|NCT02529553|EG006|Reported Event|LY3076226-4.0mg/kg|Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
11246767|NCT02529553|EG007|Reported Event|LY3076226-5.0mg/kg|Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
11246768|NCT02529553|EG008|Reported Event|LY3076226-5.0mg/kg Dose Expansion|Part B dose expansion of LY3076226 at 5.0mg/kg.
11246769|NCT02529995|BG000|Baseline|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
11246770|NCT02529995|BG001|Baseline|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
11246771|NCT02529995|BG002|Baseline|Total|Total of all reporting groups
11246772|NCT02529995|FG000|Participant Flow|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
11246773|NCT02529995|FG001|Participant Flow|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
11246774|NCT02529995|OG000|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
11246775|NCT02529995|OG001|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
11246776|NCT02529995|EG000|Reported Event|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
11246777|NCT02529995|EG001|Reported Event|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
11246778|NCT02530125|BG000|Baseline|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
11246779|NCT02530125|FG000|Participant Flow|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
11246780|NCT02530125|OG000|Outcome|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
11246781|NCT02530125|EG000|Reported Event|Treatment (Pidilizumab)|"Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pidilizumab: Given IV"
11246782|NCT02530151|BG000|Baseline|Morphine With Clonidine|"11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure~Morphine with clonidine: see arm description"
11246783|NCT02530151|BG001|Baseline|Normal Saline|"11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure~Normal saline: see arm description"
11246784|NCT02530151|BG002|Baseline|Total|Total of all reporting groups
11246785|NCT02530151|FG000|Participant Flow|Morphine With Clonidine|"11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure~Morphine with clonidine: see arm description"
11246786|NCT02530151|FG001|Participant Flow|Normal Saline|"11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure~Normal saline: see arm description"
11246787|NCT02530151|OG000|Outcome|Morphine With Clonidine|"11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure~Morphine with clonidine: see arm description"
11246788|NCT02530151|OG001|Outcome|Normal Saline|"11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure~Normal saline: see arm description"
11246789|NCT02530151|EG000|Reported Event|Morphine With Clonidine|"11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure~Morphine with clonidine: see arm description"
11246790|NCT02530151|EG001|Reported Event|Normal Saline|"11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure~Normal saline: see arm description"
11246791|NCT02530242|BG000|Baseline|End-tidal Carbon Monoxide Subjects|"Children between 1-18 years old with Sickle Cell Anemia~End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls."
11246792|NCT02530242|BG001|Baseline|End-tidal Carbon Monoxide Controls|"Healthy children age and gender matched with subjects.~End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls."
11246793|NCT02530242|BG002|Baseline|Total|Total of all reporting groups
11246794|NCT02530242|FG000|Participant Flow|End-tidal Carbon Monoxide Subjects|"Children between 1-18 years old with Sickle Cell Anemia~End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls."
11246795|NCT02530242|FG001|Participant Flow|End-tidal Carbon Monoxide Controls|"Healthy children age and gender matched with subjects.~End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls."
11246796|NCT02530242|OG000|Outcome|End-tidal Carbon Monoxide Subjects|"Children between 1-18 years old with Sickle Cell Anemia~End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls."
11246797|NCT02530242|OG001|Outcome|End-tidal Carbon Monoxide Controls|"Healthy children age and gender matched with subjects.~End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls."
11246798|NCT02530242|EG000|Reported Event|End-tidal Carbon Monoxide Subjects|"Children between 1-18 years old with Sickle Cell Anemia~End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls."
11246799|NCT02530242|EG001|Reported Event|End-tidal Carbon Monoxide Controls|"Healthy children age and gender matched with subjects.~End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls."
11246800|NCT02530281|BG000|Baseline|Glycopyrronium|glycopyrronium Topical Wipes
11246801|NCT02530281|BG001|Baseline|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246802|NCT02530281|BG002|Baseline|Total|Total of all reporting groups
11246803|NCT02530281|FG000|Participant Flow|Glycopyrronium|Glycopyrronium Topical Wipes
11246804|NCT02530281|FG001|Participant Flow|Vehicle|Glycopyrronium Topical Wipes, Vehicle
11246805|NCT02530281|OG000|Outcome|Glycopyrronium|glycopyrronium Topical Wipes
11246806|NCT02530281|OG001|Outcome|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246807|NCT02530281|OG000|Outcome|Glycopyrronium|Glycopyrronium Topical Wipes
11246808|NCT02530281|OG001|Outcome|Vehicle|Glycopyrronium Topical Wipes, Vehicle
11246809|NCT02530281|EG000|Reported Event|Glycopyrronium|glycopyrronium Topical Wipes
11246810|NCT02530281|EG001|Reported Event|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246811|NCT02530294|BG000|Baseline|Glycopyrronium|glycopyrronium Topical Wipes
11246812|NCT02530294|BG001|Baseline|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246813|NCT02530294|BG002|Baseline|Total|Total of all reporting groups
11246814|NCT02530294|FG000|Participant Flow|Glycopyrronium|glycopyrronium Topical Wipes
11246815|NCT02530294|FG001|Participant Flow|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246816|NCT02530294|OG000|Outcome|Glycopyrronium|glycopyrronium Topical Wipes
11246817|NCT02530294|OG001|Outcome|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246818|NCT02530294|EG000|Reported Event|Glycopyrronium|glycopyrronium Topical Wipes
11246819|NCT02530294|EG001|Reported Event|Vehicle|glycopyrronium Topical Wipes, Vehicle
11246820|NCT02530385|BG000|Baseline|FMT Capsules|"Active FMT capsules~FMT Capsules: Capsules will be generated as per FDA-approved procedures"
11246821|NCT02530385|BG001|Baseline|Placebo|"Placebo capsules~Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin"
11246822|NCT02530385|BG002|Baseline|Total|Total of all reporting groups
11246823|NCT02530385|FG000|Participant Flow|Placebo|"Placebo capsules~Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin"
11246824|NCT02530385|FG001|Participant Flow|FMT Capsules|"Active FMT capsules~FMT Capsules: Capsules will be generated as per FDA-approved procedures"
11246825|NCT02530385|OG000|Outcome|Placebo|"Placebo capsules~Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin"
11246826|NCT02530385|OG001|Outcome|FMT Capsules|"Active FMT capsules~FMT Capsules: Capsules will be generated as per FDA-approved procedures"
11246827|NCT02530385|EG000|Reported Event|Placebo|"Placebo capsules~Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin"
11246828|NCT02530385|EG001|Reported Event|FMT Capsules|"Active FMT capsules~FMT Capsules: Capsules will be generated as per FDA-approved procedures"
11246829|NCT02530450|BG000|Baseline|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246830|NCT02530450|BG001|Baseline|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246831|NCT02530450|BG002|Baseline|Total|Total of all reporting groups
11246832|NCT02530450|FG000|Participant Flow|Group 1|Initially blinded to continuous glucose monitoring data
11246833|NCT02530450|FG001|Participant Flow|Group 2|Never blinded to continuous glucose monitoring data
11246834|NCT02530450|OG000|Outcome|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246835|NCT02530450|OG001|Outcome|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246836|NCT02530450|EG000|Reported Event|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246837|NCT02530450|EG001|Reported Event|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
11246838|NCT02530476|BG000|Baseline|Phase I Group 1 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246839|NCT02530476|BG001|Baseline|Phase I Group 2 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle."
11246840|NCT02530476|BG002|Baseline|Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246841|NCT02530476|BG003|Baseline|Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246842|NCT02530476|BG004|Baseline|Total|Total of all reporting groups
11246843|NCT02530476|FG000|Participant Flow|Phase I Group 1 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246844|NCT02530476|FG001|Participant Flow|Phase I Group 2 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle."
11286312|NCT02886494|OG001|Outcome|BAC Matched Vehicle|BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286313|NCT02886494|OG001|Outcome|Matched Vehicle|Matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286314|NCT02886494|EG000|Reported Event|BAC Treatment|BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11246845|NCT02530476|FG002|Participant Flow|Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246846|NCT02530476|FG003|Participant Flow|Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246847|NCT02530476|OG000|Outcome|Phase I Group 1 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246848|NCT02530476|OG001|Outcome|Phase I Group 2 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle."
11246849|NCT02530476|OG002|Outcome|Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246850|NCT02530476|OG003|Outcome|Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246851|NCT02530476|EG000|Reported Event|Phase I Group 1 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246852|NCT02530476|EG001|Reported Event|Phase I Group 2 Selinexor + Sorafenib|"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.~Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle."
11246853|NCT02530476|EG002|Reported Event|Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246854|NCT02530476|EG003|Reported Event|Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)|"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.~Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
11246855|NCT02530515|BG000|Baseline|Arm A|Receive lymphodepletion chemotherapy followed by activated T-cell infusion
11246856|NCT02530515|BG001|Baseline|Arm B|Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is>1.5x109/L
11246857|NCT02530515|BG002|Baseline|Arm C|Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
11246858|NCT02530515|BG003|Baseline|Total|Total of all reporting groups
11246859|NCT02530515|FG000|Participant Flow|Arm A|Receive lymphodepletion chemotherapy followed by activated T-cell infusion
11246860|NCT02530515|FG001|Participant Flow|Arm B|Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is>1.5x109/L
11246861|NCT02530515|FG002|Participant Flow|Arm C|Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
11246862|NCT02530515|OG000|Outcome|Arm A|Receive lymphodepletion chemotherapy followed by activated T-cell infusion
11246863|NCT02530515|OG001|Outcome|Arm B|Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is>1.5x109/L
11246864|NCT02530515|OG002|Outcome|Arm C|Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
11246865|NCT02530515|EG000|Reported Event|Arm A|Receive lymphodepletion chemotherapy followed by activated T-cell infusion
11246866|NCT02530515|EG001|Reported Event|Arm B|Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is>1.5x109/L
11246867|NCT02530515|EG002|Reported Event|Arm C|Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
11246868|NCT02530528|BG000|Baseline|CHG 1, CHG 2, CHG 3, Comparator CHG|Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min, CHG at 3 min or Comparator CHG.
11246869|NCT02530528|FG000|Participant Flow|CHG 1 Min Abdomen|"1 min application time~CHG: Varied application times"
11246870|NCT02530528|FG001|Participant Flow|CHG 1 Min Groin|"1 min application time~CHG: Varied application times"
11246871|NCT02530528|FG002|Participant Flow|CHG 2 Min Abdomen|"2 min application time~CHG: Varied application times"
11246872|NCT02530528|FG003|Participant Flow|CHG 2 Min Groin|"2 min application time~CHG: Varied application times"
11246873|NCT02530528|FG004|Participant Flow|CHG 3 Min Abdomen|3 min application time
11246874|NCT02530528|FG005|Participant Flow|CHG 3 Min Groin|3 min application time
11246875|NCT02530528|FG006|Participant Flow|Comparator CHG Abdomen|Marketed CHG - only applied per products instructions for use
11246876|NCT02530528|FG007|Participant Flow|Comparator CHG Groin|Marketed CHG - only applied per products instructions for use
11246877|NCT02530528|OG000|Outcome|CHG 1 Min Abdomen|1 min application time.
11246878|NCT02530528|OG001|Outcome|CHG 1 Min Groin|1 min application time.
11246879|NCT02530528|OG002|Outcome|CHG 2 Min Abdomen|2 min application time.
11246880|NCT02530528|OG003|Outcome|CHG 2 Min Groin|2 min application time
11246881|NCT02530528|OG004|Outcome|CHG 3 Min Abdomen|3 minute application time
11246882|NCT02530528|OG005|Outcome|CHG 3 Min Groin|3 minute application time
11246883|NCT02530528|OG006|Outcome|Comparator CHG Abdomen|Comparator CHG solution
11246884|NCT02530528|OG007|Outcome|Comparator CHG Groin|Comparator CHG solution
11246885|NCT02530528|EG000|Reported Event|CHG 1 Min|1 min application time
11246886|NCT02530528|EG001|Reported Event|CHG 2 Min|2 min application time
11246887|NCT02530528|EG002|Reported Event|CHG 3 Min|3 minute application time
11246888|NCT02530528|EG003|Reported Event|Comparator CHG|Instructions for use
11246889|NCT02530541|BG000|Baseline|CHG 1, CHG 2, Comparator CHG|Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min or Comparator CHG.
11246890|NCT02530541|FG000|Participant Flow|CHG 1 Min Abdomen|CHG 1 min Abdomen sites
11246891|NCT02530541|FG001|Participant Flow|CHG 2 Min Abdomen|CHG 2 min Abdomen sites
11246892|NCT02530541|FG002|Participant Flow|Comparator CHG Abdomen|Marketed CHG - only applied per products instructions for use
11246893|NCT02530541|FG003|Participant Flow|CHG 1 Min Groin|CHG 1 min Groin sites
11246894|NCT02530541|FG004|Participant Flow|CHG 2 Min Groin|CHG 2 min Groin sites
11246895|NCT02530541|FG005|Participant Flow|Comparator CHG Groin|Marketed CHG - only applied per products instructions for use
11246896|NCT02530541|OG000|Outcome|CHG 1 Min Abdomen|1 min application time
11246897|NCT02530541|OG001|Outcome|CHG 2 Min Abdomen|2 min application time
11246898|NCT02530541|OG002|Outcome|Comparator CHG Abdomen|Marketed CHG Standard Application Time
11246899|NCT02530541|OG003|Outcome|CHG 1 Min Groin|1 min application time
11246900|NCT02530541|OG004|Outcome|CHG 2 Min Groin|2 min application time
11246901|NCT02530541|OG005|Outcome|Comparator CHG Groin|Comparator CHG Standard Application Time
11246902|NCT02530541|EG000|Reported Event|CHG 1 Min, CHG 2 Min, Comparator CHG|1 min application time, 2 min application time or comparator application. Up to 2 products applied to the same participant.
11246903|NCT02530554|BG000|Baseline|CHG 3 Min, Comparator CHG|CHG applied for 3 min, Comparator CHG applied per instructions.
11246904|NCT02530554|FG000|Participant Flow|CHG 3 Min Abdomen|3 min application time
11246905|NCT02530554|FG001|Participant Flow|CHG 3 Min Groin|3 min application time
11246906|NCT02530554|FG002|Participant Flow|Comparator CHG Abdomen|Comparator CHG on abdomen sites
11246907|NCT02530554|FG003|Participant Flow|Comparator CHG Groin|Comparator CHG on groin sites
11246908|NCT02530554|OG000|Outcome|CHG 3 Min Abdomen|3 min application time
11246909|NCT02530554|OG001|Outcome|CHG 3 Min Groin|3 min application time
11246910|NCT02530554|OG002|Outcome|Comparator CHG Abdomen|CHG comparator applied to abdomen
11246911|NCT02530554|OG003|Outcome|Comparator CHG Groin|CHG Comparator applied to groin
11246912|NCT02530554|EG000|Reported Event|CHG 3 Min and Comparator CHG|3 min application time for CHG and the comparator CHG was applied according to instructions.
11286315|NCT02886494|EG001|Reported Event|Matched Vehicle|BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
11286316|NCT02886624|BG000|Baseline|Grazoprevir/Elbasvir|"Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks~Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks"
11246913|NCT02530619|BG000|Baseline|Alisertib 50 mg BID|"Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11246914|NCT02530619|FG000|Participant Flow|Alisertib 50 mg BID|"Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11246915|NCT02530619|OG000|Outcome|Alisertib 50 mg BID|"Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11246916|NCT02530619|EG000|Reported Event|Alisertib 50 mg BID|"Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
11246917|NCT02530671|BG000|Baseline|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
11246918|NCT02530671|BG001|Baseline|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
11246919|NCT02530671|BG002|Baseline|Total|Total of all reporting groups
11246920|NCT02530671|FG000|Participant Flow|Manual Toothbrush|"ADA (American Dental Association) reference manual toothbrush~Toothbrushing with manual toothbrush"
11246921|NCT02530671|FG001|Participant Flow|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
11246922|NCT02530671|OG000|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
11246923|NCT02530671|OG001|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
11246924|NCT02530671|EG000|Reported Event|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
11246925|NCT02530671|EG001|Reported Event|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
11246926|NCT02530905|BG000|Baseline|Double-Blind Period: Placebo|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received placebo-matched to casimersen IV infusions, once weekly over approximately 12 weeks in the double-blind period.
11246927|NCT02530905|BG001|Baseline|Double-Blind Period: Casimersen|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received weekly IV infusions of casimersen at four escalating dose levels, each for at least 2 weeks: 4 mg/kg during Week 1 to Week 2, followed by 10 mg/kg during Week 3 to Week 4, followed by 20 mg/kg during Week 5 to Week 6, followed by 30 mg/kg beginning at Week 7 and continued over approximately Week 12 in the double-blind period.
11246928|NCT02530905|BG002|Baseline|Total|Total of all reporting groups
11246929|NCT02530905|FG000|Participant Flow|Double-Blind Period: Placebo|Participants with genotypically confirmed Duchenne muscular dystrophy (DMD) characterized by deletions amenable to exon 45 skipping received placebo-matched to casimersen intravenous (IV) infusions, once weekly over approximately 12 weeks in the double-blind period.
11246930|NCT02530905|FG001|Participant Flow|Double-Blind Period: Casimersen|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received weekly IV infusions of casimersen at four escalating dose levels, each for at least 2 weeks: 4 milligrams per kilograms (mg/kg) during Week 1 to Week 2, followed by 10 mg/kg during Week 3 to Week 4, followed by 20 mg/kg during Week 5 to Week 6, followed by 30 mg/kg beginning at Week 7 and continued over approximately Week 12 in the double-blind period.
11246931|NCT02530905|FG002|Participant Flow|Open Label Extension Period: Casimersen|All participants who completed double blind period were enrolled to receive casimersen 30 mg/kg once weekly, for up to Week 144 in the open label extension period.
11246932|NCT02530905|OG000|Outcome|Double-Blind Period: Placebo|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received placebo-matched to casimersen IV infusions, once weekly over approximately 12 weeks in the double-blind period.
11246933|NCT02530905|OG001|Outcome|Double-Blind Period: Casimersen 4 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 4 mg/kg once weekly for 2 weeks (i.e. Week 1 to Week 2) in the double-blind period.
11246934|NCT02530905|OG002|Outcome|Double-Blind Period: Casimersen 10 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 10 mg/kg once weekly for 2 weeks (i.e. Week 3 to Week 4) in the double-blind period.
11246935|NCT02530905|OG003|Outcome|Double-Blind Period: Casimersen 20 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 20 mg/kg once weekly for 2 weeks (i.e. Week 5 to Week 6) in the double-blind period.
11246936|NCT02530905|OG004|Outcome|Double-Blind Period: Casimersen 30 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 30 mg/kg once weekly from Week 7 to Week 12 in the double-blind period.
11246937|NCT02530905|OG005|Outcome|Open Label Extension Period: Casimersen 30 mg/kg|All participants who completed double blind period were enrolled to receive casimersen 30 mg/kg once weekly, for up to Week 144 in the open label extension period.
11246938|NCT02530905|OG003|Outcome|Double-Blind Period: Casimersen 20 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 20 mg/kg once weekly for 2 weeks (i.e. Week 5 to Week 6) in the double-blind period
11246939|NCT02530905|OG005|Outcome|Open Label Extension Period: Casimersen 30 mg/kg|All participants who completed double blind period were enrolled to receive casimersen 30 mg/kg once weekly, for up to Week 144 in the open label extension period
11246940|NCT02530905|OG000|Outcome|Double-Blind Period: Casimersen 4 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 4 mg/kg once weekly for 2 weeks (i.e. Week 1 to Week 2) in the double-blind period.
11246941|NCT02530905|OG001|Outcome|Double-Blind Period: Casimersen 10 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 10 mg/kg once weekly for 2 weeks (i.e. Week 3 to Week 4) in the double-blind period.
11246942|NCT02530905|OG002|Outcome|Double-Blind Period: Casimersen 20 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 20 mg/kg once weekly for 2 weeks (i.e. Week 5 to Week 6) in the double-blind period.
11246943|NCT02530905|OG003|Outcome|Double-Blind Period: Casimersen 30 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 30 mg/kg once weekly from Week 7 to Week 12 in the double-blind period.
11246944|NCT02530905|OG004|Outcome|Open Label Extension Period: Casimersen 30 mg/kg|All participants who completed double blind period were enrolled to receive casimersen 30 mg/kg once weekly, for up to Week 144 in the open label extension period.
11246945|NCT02530905|OG002|Outcome|Double-Blind Period: Casimersen 20 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 20 mg/kg once weekly for 2 weeks (i.e. Week 5 to Week 6) in the double-blind period
11246946|NCT02530905|EG000|Reported Event|Double-Blind Period: Placebo|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received placebo-matched to casimersen IV infusions, once weekly over approximately 12 weeks in the double-blind period.
11246947|NCT02530905|EG001|Reported Event|Double-Blind Period: Casimersen 4 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 4 mg/kg once weekly for 2 weeks (i.e. Week 1 to Week 2) in the double-blind period.
11246948|NCT02530905|EG002|Reported Event|Double-Blind Period: Casimersen 10 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 10 mg/kg once weekly for 2 weeks (i.e. Week 3 to Week 4) in the double-blind period.
11246949|NCT02530905|EG003|Reported Event|Double-Blind Period: Casimersen 20 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 20 mg/kg once weekly for 2 weeks (i.e. Week 5 to Week 6) in the double-blind period.
11246950|NCT02530905|EG004|Reported Event|Double-Blind Period: Casimersen 30 mg/kg|Participants with genotypically confirmed DMD characterized by deletions amenable to exon 45 skipping received casimersen IV infusions, at a dose level of 30 mg/kg once weekly from Week 7 to Week 12 in the double-blind period.
11246951|NCT02530905|EG005|Reported Event|Open Label Extension Period: Casimersen 30 mg/kg|All participants who completed double blind period were enrolled to receive casimersen 30 mg/kg once weekly, for up to Week 144 in the open label extension period.
11246952|NCT02530970|BG000|Baseline|CanGaroo|Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
11246953|NCT02530970|FG000|Participant Flow|CanGaroo|Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
11246954|NCT02530970|OG000|Outcome|CanGaroo|Arm/group includes all study participants.
11246955|NCT02530970|EG000|Reported Event|CanGaroo|Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
11246956|NCT02530996|BG000|Baseline|12 SSc Patients Received BH4 and Placebo|"12 SSc received BH4 intervention (blinded) and placebo in a cross-over design.~Patients were studied 5 hours after oral BH4 administration (10 mg/kg body mass) or placebo on separate days using controlled, counterbalanced, double-blind, crossover experimental design~Vasculopathy assessment: Non-invasive technique, flow mediated dilatation (FMD) to define vasculopathy in SSc."
11246957|NCT02530996|FG000|Participant Flow|6 SSc Patients Received BH4 Then Placebo|Prior to January 18, 2017, a controlled, counter-balanced, double-blind, crossover experimental design with two conditions, BH4 and placebo, was employed. There was a washout period of at least 5 days before crossing over into the alternate condition.
11246958|NCT02530996|FG001|Participant Flow|6 SSc Patients Received Placebo Then BH4|Prior to January 18, 2017, a controlled, counter-balanced, double-blind, crossover experimental design with two conditions, BH4 and placebo, was employed. There was a washout period of at least 5 days before crossing over into the alternate condition.
11246959|NCT02530996|OG000|Outcome|12 SSc Participants With Placebo|12 patients were studied 5 hours after oral BH4 administration (10 mg/kg body mass) or placebo on separate days using controlled, counterbalanced, double-blind, crossover experimental design.
11246960|NCT02530996|OG001|Outcome|12 Participants With BH4|12 patients were studied 5 hours after oral BH4 administration (10 mg/kg body mass) or placebo on separate days using controlled, counterbalanced, double-blind, crossover experimental design.
11246961|NCT02530996|OG000|Outcome|12 SSc Participants After Placebo|Twelve SSc patients were studied 5 hours after oral BH4 administration (10 mg/kg body mass) or placebo on separate days using controlled, counterbalanced, double-blind, crossover experimental design.
11246962|NCT02530996|OG001|Outcome|12 SSc Participants After BH4|Twelve SSc patients were studied 5 hours after oral BH4 administration (10 mg/kg body mass) or placebo on separate days using controlled, counterbalanced, double-blind, crossover experimental design.
11286317|NCT02886624|FG000|Participant Flow|Grazoprevir/Elbasvir|"Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks~Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks"
11286318|NCT02886624|OG000|Outcome|Grazoprevir/Elbasvir|"Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks~Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks"
11246963|NCT02530996|OG000|Outcome|12 SSc Patients Oxidative Stress After Placebo|Blood samples were obtained from the antecubital patients with SSc. Serum and plasma samples were stored at -80°C until analysis. Oxidative stress was assessed by quantifying plasma malondialdehyde (MDA) (Oxis Research/Percipio Bioscience, Foster City, CA) and protein carbonyl levels (Northwest Life Science Specialties, LLC Vancouver, WA). Endogenous antioxidant capacity, assessed by superoxide dismutase (SOD) and catalase (CAT) activity, were assayed in the plasma (Cayman Chemical Company, Ann Arbor, MI). Additionally, total antioxidant capacity was assessed by measuring the ferric reducing ability of plasma (FRAP), using the method described by Benzie and Strain (17). Systemic inflammation was assessed by determining IL-6, TNF-α (18) and C-reactive protein (CRP) in serum (R&D Systems, Minneapolis, MN).
11246964|NCT02530996|OG001|Outcome|12 SSc Patients Oxidative Stress After BH4|Blood samples were obtained from the antecubital patients with SSc. Serum and plasma samples were stored at -80°C until analysis. Oxidative stress was assessed by quantifying plasma malondialdehyde (MDA) (Oxis Research/Percipio Bioscience, Foster City, CA) and protein carbonyl levels (Northwest Life Science Specialties, LLC Vancouver, WA). Endogenous antioxidant capacity, assessed by superoxide dismutase (SOD) and catalase (CAT) activity, were assayed in the plasma (Cayman Chemical Company, Ann Arbor, MI). Additionally, total antioxidant capacity was assessed by measuring the ferric reducing ability of plasma (FRAP), using the method described by Benzie and Strain (17). Systemic inflammation was assessed by determining IL-6, TNF-α (18) and C-reactive protein (CRP) in serum (R&D Systems, Minneapolis, MN).
11246965|NCT02530996|EG000|Reported Event|12 SSc Participants Placebo|12 SSc participants were studied 5 hours after oral placebo administration (10 mg/kg body mass)
11246966|NCT02530996|EG001|Reported Event|12 SSc Participants BH4|12 SSc participants were studied 5 hours after oral BH4 administration (10 mg/kg body mass)
11246967|NCT02531022|BG000|Baseline|Control|Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device and received daily feedback.
11246968|NCT02531022|BG001|Baseline|Intervention|"Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device, received daily feedback and were eligible for a financial incentive if their goals were achieved.~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not achieved"
11246969|NCT02531022|BG002|Baseline|Total|Total of all reporting groups
11246970|NCT02531022|FG000|Participant Flow|Standard Exercise/Control|Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device and received daily feedback.
11246971|NCT02531022|FG001|Participant Flow|Daily Feedback With Financial Incentive|"Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device, received daily feedback and were eligible for a financial incentive if their goals were achieved.~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not achieved"
11246972|NCT02531022|OG000|Outcome|Control|"Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback.~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns"
11246973|NCT02531022|OG001|Outcome|Intervention|"Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives~Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not acheived~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns"
11246974|NCT02531022|EG000|Reported Event|Control|"Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback.~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns"
11246975|NCT02531022|EG001|Reported Event|Intervention|"Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives~Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not acheived~Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns"
11246976|NCT02531035|BG000|Baseline|Placebo|Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
11246977|NCT02531035|BG001|Baseline|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
11246978|NCT02531035|BG002|Baseline|Total|Total of all reporting groups
11246979|NCT02531035|FG000|Participant Flow|Placebo|Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
11246980|NCT02531035|FG001|Participant Flow|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
11246981|NCT02531035|OG000|Outcome|Placebo|Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
11246982|NCT02531035|OG001|Outcome|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
11246983|NCT02531035|EG000|Reported Event|Placebo|Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
11246984|NCT02531035|EG001|Reported Event|Sotagliflozin 400 mg|Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
11246985|NCT02531113|BG000|Baseline|Ozanimod Hydrochloride (HCl) 1 mg|Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
11246986|NCT02531113|FG000|Participant Flow|Ozanimod Hydrochloride (HCl) 1 mg|Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
11246987|NCT02531113|OG000|Outcome|Ozanimod Hydrochloride (HCl) 1 mg|Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
11246988|NCT02531113|EG000|Reported Event|Ozanimod|Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204.
11246989|NCT02531321|BG000|Baseline|Ritonavir|"Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246990|NCT02531321|BG001|Baseline|Control|"Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246991|NCT02531321|BG002|Baseline|Total|Total of all reporting groups
11246992|NCT02531321|FG000|Participant Flow|Ritonavir|"Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11286319|NCT02886624|EG000|Reported Event|Grazoprevir/Elbasvir|"Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks~Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks"
11286320|NCT02886702|BG000|Baseline|Test|Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
11286321|NCT02886702|BG001|Baseline|Reference|TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
11246993|NCT02531321|FG001|Participant Flow|Control|"Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246994|NCT02531321|OG000|Outcome|Ritonavir|"Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246995|NCT02531321|OG001|Outcome|Control|"Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246996|NCT02531321|EG000|Reported Event|Ritonavir|"Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246997|NCT02531321|EG001|Reported Event|Control|"Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.~Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives."
11246998|NCT02531373|BG000|Baseline|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
11246999|NCT02531373|BG001|Baseline|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
11247000|NCT02531373|BG002|Baseline|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
11247001|NCT02531373|BG003|Baseline|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
11247002|NCT02531373|BG004|Baseline|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
11247003|NCT02531373|BG005|Baseline|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
11247004|NCT02531373|BG006|Baseline|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
11247005|NCT02531373|BG007|Baseline|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
11247006|NCT02531373|BG008|Baseline|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
11247007|NCT02531373|BG009|Baseline|Total|Total of all reporting groups
11247008|NCT02531373|FG000|Participant Flow|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
11247009|NCT02531373|FG001|Participant Flow|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
11247010|NCT02531373|FG002|Participant Flow|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
11247011|NCT02531373|FG003|Participant Flow|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
11247012|NCT02531373|FG004|Participant Flow|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
11247013|NCT02531373|FG005|Participant Flow|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
11247014|NCT02531373|FG006|Participant Flow|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
11247015|NCT02531373|FG007|Participant Flow|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
11247016|NCT02531373|FG008|Participant Flow|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
11247017|NCT02531373|OG000|Outcome|Adults: V114 Medium Dose|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
11247018|NCT02531373|OG001|Outcome|Adults: V114 High Dose|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
11247019|NCT02531373|OG002|Outcome|Adults: V114 Medium Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
11247020|NCT02531373|OG003|Outcome|Adults: V114 High Dose + ACP|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
11247021|NCT02531373|OG000|Outcome|Infants: V114 Medium Dose|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
11247022|NCT02531373|OG001|Outcome|Infants: V114 High Dose|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
11247023|NCT02531373|OG002|Outcome|Infants: V114 Medium Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
11247024|NCT02531373|OG003|Outcome|Infants: V114 High Dose + ACP|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
11247025|NCT02531373|OG004|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
11247026|NCT02531373|OG002|Outcome|Infants: Prevnar 13™|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
11247027|NCT02531373|EG000|Reported Event|V114 Medium Adults|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
11247028|NCT02531373|EG001|Reported Event|V114 High Adults|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
11247029|NCT02531373|EG002|Reported Event|V114 Medium + ACP Adults|Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
11247030|NCT02531373|EG003|Reported Event|V114 High + ACP Adults|Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
11247031|NCT02531373|EG004|Reported Event|V114 Medium Infants|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
11247032|NCT02531373|EG005|Reported Event|V114 High Infants|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
11247033|NCT02531373|EG006|Reported Event|V114 Medium + ACP Infants|Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
11247034|NCT02531373|EG007|Reported Event|V114 High + ACP Infants|Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
11247035|NCT02531373|EG008|Reported Event|Prevnar 13 Infants|Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
11247036|NCT02531438|BG000|Baseline|Omadacycline|Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247037|NCT02531438|BG001|Baseline|Moxifloxacin|Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247038|NCT02531438|BG002|Baseline|Total|Total of all reporting groups
11247039|NCT02531438|FG000|Participant Flow|Omadacycline|Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247040|NCT02531438|FG001|Participant Flow|Moxifloxacin|Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247041|NCT02531438|OG000|Outcome|Omadacycline|Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247042|NCT02531438|OG001|Outcome|Moxifloxacin|Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247043|NCT02531438|EG000|Reported Event|Omadacycline|Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11286322|NCT02886702|BG002|Baseline|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286323|NCT02886702|BG003|Baseline|Total|Total of all reporting groups
11213398|NCT02286518|FG010|Participant Flow|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213399|NCT02286518|FG011|Participant Flow|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213400|NCT02286518|FG012|Participant Flow|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213401|NCT02286518|FG013|Participant Flow|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213402|NCT02286518|OG000|Outcome|Part 1 SRD-Cohort 1A - 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213403|NCT02286518|OG001|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213404|NCT02286518|OG002|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213405|NCT02286518|OG003|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213406|NCT02286518|OG004|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213407|NCT02286518|OG005|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213408|NCT02286518|OG006|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213409|NCT02286518|OG007|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213410|NCT02286518|OG008|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213411|NCT02286518|OG009|Outcome|Part 3 Placebo Cohort 5A - 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213412|NCT02286518|OG010|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213413|NCT02286518|OG011|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213414|NCT02286518|OG012|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213415|NCT02286518|OG013|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213416|NCT02286518|OG000|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213417|NCT02286518|OG001|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213418|NCT02286518|OG002|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213419|NCT02286518|OG003|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213420|NCT02286518|OG004|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213421|NCT02286518|OG005|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213422|NCT02286518|OG006|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213423|NCT02286518|OG007|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213424|NCT02286518|OG008|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213425|NCT02286518|OG009|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213426|NCT02286518|OG010|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213427|NCT02286518|OG011|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213428|NCT02286518|OG000|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213429|NCT02286518|OG001|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213430|NCT02286518|OG002|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213431|NCT02286518|OG003|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11247044|NCT02531438|EG001|Reported Event|Moxifloxacin|Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
11247045|NCT02531633|BG000|Baseline|SIR100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
11247046|NCT02531633|BG001|Baseline|SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
11247047|NCT02531633|BG002|Baseline|SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247048|NCT02531633|BG003|Baseline|Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247049|NCT02531633|BG004|Baseline|Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
11247050|NCT02531633|BG005|Baseline|Total|Total of all reporting groups
11247051|NCT02531633|FG000|Participant Flow|Part A:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
11247052|NCT02531633|FG001|Participant Flow|Part A:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
11247053|NCT02531633|FG002|Participant Flow|Part A:SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247054|NCT02531633|FG003|Participant Flow|Part A:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247055|NCT02531633|FG004|Participant Flow|Part A:Placebo SC q2w+12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
11247056|NCT02531633|FG005|Participant Flow|Part B:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
11247057|NCT02531633|FG006|Participant Flow|Part B:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
11247058|NCT02531633|FG007|Participant Flow|Part B:SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247059|NCT02531633|FG008|Participant Flow|Part B:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247060|NCT02531633|FG009|Participant Flow|Part B:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
11247061|NCT02531633|OG000|Outcome|PartA:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
11247062|NCT02531633|OG001|Outcome|PartA:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
11247063|NCT02531633|OG002|Outcome|PartA:SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247064|NCT02531633|OG003|Outcome|PartA:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247065|NCT02531633|OG004|Outcome|PartA:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
11247066|NCT02531633|OG000|Outcome|PartB:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
11247067|NCT02531633|OG001|Outcome|Part B:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
11247068|NCT02531633|OG002|Outcome|PartB:SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247069|NCT02531633|OG003|Outcome|Part B:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247070|NCT02531633|OG004|Outcome|Part B:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
11247071|NCT02531633|OG001|Outcome|PartB:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
11247072|NCT02531633|OG003|Outcome|PartB:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247073|NCT02531633|OG004|Outcome|PartB:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
11247074|NCT02531633|OG002|Outcome|PartA:SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
11286324|NCT02886702|FG000|Participant Flow|Test|Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
11247075|NCT02531633|OG003|Outcome|PartB:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimenin Part A
11247076|NCT02531633|OG000|Outcome|PartBSIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
11247077|NCT02531633|OG001|Outcome|PartBSIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
11247078|NCT02531633|OG003|Outcome|PartBPlacebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
11247079|NCT02531633|OG004|Outcome|PartBPlacebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
11247080|NCT02531633|OG000|Outcome|PartB:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A
11247081|NCT02531633|OG001|Outcome|PartB:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A
11247082|NCT02531633|OG003|Outcome|PartB:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A
11247083|NCT02531633|OG004|Outcome|PartB:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
11247084|NCT02531633|EG000|Reported Event|Part A:SIR 100 mg SC q2w+6 Month Prednisone|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
11247085|NCT02531633|EG001|Reported Event|Part A:SIR 100 mg SC q2w+3 Month Prednisone|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
11247086|NCT02531633|EG002|Reported Event|Part A: SIR 50 mg SC q4w+6 Month Prednisone|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247087|NCT02531633|EG003|Reported Event|Part A:Placebo SC q2w + 6 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
11247088|NCT02531633|EG004|Reported Event|Part A:Placebo SC q2w + 12 Month Prednisone|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
11247089|NCT02531633|EG005|Reported Event|Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
11247090|NCT02531633|EG006|Reported Event|Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
11247091|NCT02531633|EG007|Reported Event|Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
11247092|NCT02531633|EG008|Reported Event|Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
11247093|NCT02531633|EG009|Reported Event|Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
11247094|NCT02531633|EG010|Reported Event|Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR|Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.
11247095|NCT02531633|EG011|Reported Event|Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR|Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
11247096|NCT02531633|EG012|Reported Event|Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR|Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
11247097|NCT02531633|EG013|Reported Event|Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
11247098|NCT02531633|EG014|Reported Event|Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR|Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
11247099|NCT02531646|BG000|Baseline|Predicate & Invest. DE - Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11286325|NCT02886702|FG001|Participant Flow|Reference|TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
11286326|NCT02886702|FG002|Participant Flow|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286327|NCT02886702|OG000|Outcome|Test|Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
11213432|NCT02286518|EG000|Reported Event|Part 1 SRD-Cohort 1A - 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213433|NCT02286518|EG001|Reported Event|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213434|NCT02286518|EG002|Reported Event|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213435|NCT02286518|EG003|Reported Event|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
11213436|NCT02286518|EG004|Reported Event|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213437|NCT02286518|EG005|Reported Event|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213438|NCT02286518|EG006|Reported Event|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
11213439|NCT02286518|EG007|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213440|NCT02286518|EG008|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
11213441|NCT02286518|EG009|Reported Event|Part 3 Placebo Cohort 5A - 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213442|NCT02286518|EG010|Reported Event|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213443|NCT02286518|EG011|Reported Event|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
11213444|NCT02286518|EG012|Reported Event|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213445|NCT02286518|EG013|Reported Event|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
11213446|NCT02286713|BG000|Baseline|Patient Decision Aid|Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213447|NCT02286713|BG001|Baseline|Standard Educational Information|Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213448|NCT02286713|BG002|Baseline|Total|Total of all reporting groups
11213449|NCT02286713|FG000|Participant Flow|Patient Decision Aid|Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213450|NCT02286713|FG001|Participant Flow|Standard Educational Information|Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213451|NCT02286713|OG000|Outcome|Patient Decision Aid|Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213452|NCT02286713|OG001|Outcome|Standard Educational Information|Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213453|NCT02286713|EG000|Reported Event|Patient Decision Aid|Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213454|NCT02286713|EG001|Reported Event|Standard Educational Information|Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
11213455|NCT02286726|BG000|Baseline|Arm I (Lower-dose (50 Units/m^2) CPX-351)|"Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213456|NCT02286726|BG001|Baseline|Arm II (Intermediate-dose (75 Units/m^2) CPX-351)|"Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213457|NCT02286726|BG002|Baseline|Arm III (Standard-dose (100 Units/m^2) CPX-351)|"Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213458|NCT02286726|BG003|Baseline|Total|Total of all reporting groups
11213459|NCT02286726|FG000|Participant Flow|Arm I (Lower-dose (50 Units/m^2) CPX-351)|"Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213460|NCT02286726|FG001|Participant Flow|Arm II (Intermediate-dose (75 Units/m^2) CPX-351)|"Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213461|NCT02286726|FG002|Participant Flow|Arm III (Standard-dose (100 Units/m^2) CPX-351)|"Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11247100|NCT02531646|BG001|Baseline|Predicate & Invest. DT - Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247101|NCT02531646|BG002|Baseline|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247102|NCT02531646|BG003|Baseline|Total|Total of all reporting groups
11247103|NCT02531646|FG000|Participant Flow|Predicate & Invest. DE - Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247104|NCT02531646|FG001|Participant Flow|Predicate & Invest. DT - Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247105|NCT02531646|FG002|Participant Flow|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247106|NCT02531646|OG000|Outcome|Predicate & Invest. DE - Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247107|NCT02531646|OG000|Outcome|Predicate & Invest. DT - Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247108|NCT02531646|OG000|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247109|NCT02531646|EG000|Reported Event|Predicate & Invest. DE - Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247110|NCT02531646|EG001|Reported Event|Predicate & Invest. DT - Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247111|NCT02531646|EG002|Reported Event|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
11247112|NCT02531698|BG000|Baseline|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247113|NCT02531698|BG001|Baseline|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247114|NCT02531698|BG002|Baseline|Total|Total of all reporting groups
11247115|NCT02531698|FG000|Participant Flow|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from greater than or equal to (>=) 24 months to less than (<) 10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247116|NCT02531698|FG001|Participant Flow|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247117|NCT02531698|OG000|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247118|NCT02531698|OG001|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11286328|NCT02886702|OG001|Outcome|Reference|TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
11247119|NCT02531698|OG002|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247120|NCT02531698|OG003|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247121|NCT02531698|OG000|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247122|NCT02531698|OG001|Outcome|Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247123|NCT02531698|OG002|Outcome|Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247124|NCT02531698|OG003|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247125|NCT02531698|OG004|Outcome|Group 2 HAV/Saline (>=24 Months to <4 Years)|Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247126|NCT02531698|OG005|Outcome|Group 2 HAV/Saline (>=4 Years to <10 Years)|Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247127|NCT02531698|OG001|Outcome|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247128|NCT02531698|EG000|Reported Event|Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247129|NCT02531698|EG001|Reported Event|Group 2 HAV/Saline (>=24 Months to <10 Years)|Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule
11247130|NCT02531802|BG000|Baseline|Adult: Placebo|"Adult arm (18-45 year olds) receiving a placebo on days 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247131|NCT02531802|BG001|Baseline|Adult: ETVAX (Full)|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
11247132|NCT02531802|BG002|Baseline|Adult: ETVAX (Full) + 10 ug dmLT|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
11247133|NCT02531802|BG003|Baseline|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247134|NCT02531802|BG004|Baseline|24-59 Months: ETVAX (1/4)|24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247135|NCT02531802|BG005|Baseline|24-59 Months: ETVAX (1/2)|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247136|NCT02531802|BG006|Baseline|24-59 Months: ETVAX (Full)|24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247137|NCT02531802|BG007|Baseline|24-59 Months: ETVAX (1/2) + 2.5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247138|NCT02531802|BG008|Baseline|24-59 Months: ETVAX (1/2) + 5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247139|NCT02531802|BG009|Baseline|24-59 Months: ETVAX (1/2) + 10 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247140|NCT02531802|BG010|Baseline|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247141|NCT02531802|BG011|Baseline|12-23 Months: ETVAX (1/4)|12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247142|NCT02531802|BG012|Baseline|12-23 Months: ETVAX (1/2)|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247143|NCT02531802|BG013|Baseline|12-23 Months: ETVAX (1/2) + 2.5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247144|NCT02531802|BG014|Baseline|12-23 Months: ETVAX (1/2) + 5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247145|NCT02531802|BG015|Baseline|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247146|NCT02531802|BG016|Baseline|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247147|NCT02531802|BG017|Baseline|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11286329|NCT02886702|OG002|Outcome|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286330|NCT02886702|EG000|Reported Event|Test|Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
11247148|NCT02531802|BG018|Baseline|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247149|NCT02531802|BG019|Baseline|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247150|NCT02531802|BG020|Baseline|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247151|NCT02531802|BG021|Baseline|Total|Total of all reporting groups
11247152|NCT02531802|FG000|Participant Flow|Adult: ETVAX (Full)|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
11247153|NCT02531802|FG001|Participant Flow|Adult: ETVAX (Full) + 10 ug dmLT|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
11247154|NCT02531802|FG002|Participant Flow|Adult: Placebo|"Adult arm (18-45 year olds) receiving a placebo on days 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247155|NCT02531802|FG003|Participant Flow|24-59 Months: ETVAX (1/4)|24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247156|NCT02531802|FG004|Participant Flow|24-59 Months: ETVAX (1/2)|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247157|NCT02531802|FG005|Participant Flow|24-59 Months: ETVAX (Full)|24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247158|NCT02531802|FG006|Participant Flow|24-59 Months: ETVAX (1/2) + 2.5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247159|NCT02531802|FG007|Participant Flow|24-59 Months: ETVAX (1/2) + 5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247160|NCT02531802|FG008|Participant Flow|24-59 Months: ETVAX (1/2) + 10 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247161|NCT02531802|FG009|Participant Flow|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247162|NCT02531802|FG010|Participant Flow|12-23 Months: ETVAX (1/4)|12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247163|NCT02531802|FG011|Participant Flow|12-23 Months: ETVAX (1/2)|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247164|NCT02531802|FG012|Participant Flow|12-23 Months: ETVAX (1/2) + 2.5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247165|NCT02531802|FG013|Participant Flow|12-23 Months: ETVAX (1/2) + 5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247166|NCT02531802|FG014|Participant Flow|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247167|NCT02531802|FG015|Participant Flow|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247168|NCT02531802|FG016|Participant Flow|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247169|NCT02531802|FG017|Participant Flow|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247170|NCT02531802|FG018|Participant Flow|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247171|NCT02531802|FG019|Participant Flow|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247172|NCT02531802|FG020|Participant Flow|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247173|NCT02531802|OG000|Outcome|Adult: ETVAX (Full)|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
11247174|NCT02531802|OG001|Outcome|Adult: ETVAX (Full) + 10 ug dmLT|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
11247175|NCT02531802|OG002|Outcome|Adult: Placebo|"Adult arm (18-45 year olds) receiving a placebo on days 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11286331|NCT02886702|EG001|Reported Event|Reference|TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
11247176|NCT02531802|OG003|Outcome|24-59 Months: ETVAX (1/4)|24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247177|NCT02531802|OG004|Outcome|24-59 Months: ETVAX (1/2)|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247178|NCT02531802|OG005|Outcome|24-59 Months: ETVAX (Full)|24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247179|NCT02531802|OG006|Outcome|24-59 Months: ETVAX (1/2) + 2.5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247180|NCT02531802|OG007|Outcome|24-59 Months: ETVAX (1/2) + 5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247181|NCT02531802|OG008|Outcome|24-59 Months: ETVAX (1/2) + 10 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247182|NCT02531802|OG009|Outcome|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247183|NCT02531802|OG010|Outcome|12-23 Months: ETVAX (1/4)|12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247184|NCT02531802|OG011|Outcome|12-23 Months: ETVAX (1/2)|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247185|NCT02531802|OG012|Outcome|12-23 Months: ETVAX (1/2) + 2.5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247186|NCT02531802|OG013|Outcome|12-23 Months: ETVAX (1/2) + 5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247187|NCT02531802|OG014|Outcome|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247188|NCT02531802|OG015|Outcome|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247189|NCT02531802|OG016|Outcome|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247190|NCT02531802|OG017|Outcome|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247191|NCT02531802|OG018|Outcome|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247192|NCT02531802|OG019|Outcome|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247193|NCT02531802|OG020|Outcome|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247194|NCT02531802|OG005|Outcome|24-59 Months: ETVAX (1/2) + 2.5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247195|NCT02531802|OG006|Outcome|24-59 Months: ETVAX (1/2) + 5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247196|NCT02531802|OG007|Outcome|24-59 Months: ETVAX (1/2) + 10 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247197|NCT02531802|OG008|Outcome|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247198|NCT02531802|OG009|Outcome|12-23 Months: ETVAX (1/4)|12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247199|NCT02531802|OG010|Outcome|12-23 Months: ETVAX (1/2)|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247200|NCT02531802|OG011|Outcome|12-23 Months: ETVAX (1/2) + 2.5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247201|NCT02531802|OG012|Outcome|12-23 Months: ETVAX (1/2) + 5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247202|NCT02531802|OG013|Outcome|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247203|NCT02531802|OG014|Outcome|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247204|NCT02531802|OG015|Outcome|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247205|NCT02531802|OG016|Outcome|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247206|NCT02531802|OG017|Outcome|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247207|NCT02531802|OG018|Outcome|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247208|NCT02531802|OG019|Outcome|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247209|NCT02531802|OG000|Outcome|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247210|NCT02531802|OG001|Outcome|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247211|NCT02531802|OG002|Outcome|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247212|NCT02531802|OG003|Outcome|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247213|NCT02531802|OG004|Outcome|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247214|NCT02531802|OG005|Outcome|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247215|NCT02531802|OG000|Outcome|Adult: Placebo|"Adult arm (18-45 year olds) receiving a placebo on days 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247216|NCT02531802|OG001|Outcome|Adult: ETVAX (Full)|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
11247217|NCT02531802|OG002|Outcome|Adult: ETVAX (Full) + 10 ug dmLT|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
11247218|NCT02531802|OG003|Outcome|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247219|NCT02531802|OG004|Outcome|24-59 Months: ETVAX (1/4)|24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247220|NCT02531802|OG005|Outcome|24-59 Months: ETVAX (1/2)|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247221|NCT02531802|OG009|Outcome|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247222|NCT02531802|OG014|Outcome|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247223|NCT02531802|EG000|Reported Event|Adult: ETVAX (Full)|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
11247224|NCT02531802|EG001|Reported Event|Adult: ETVAX (Full) + 10 ug dmLT|Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
11247225|NCT02531802|EG002|Reported Event|Adult: Placebo|"Adult arm (18-45 year olds) receiving a placebo on days 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247226|NCT02531802|EG003|Reported Event|24-59 Months: ETVAX (1/4)|24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247227|NCT02531802|EG004|Reported Event|24-59 Months: ETVAX (1/2)|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247228|NCT02531802|EG005|Reported Event|24-59 Months: ETVAX (Full)|24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247229|NCT02531802|EG006|Reported Event|24-59 Months: ETVAX (1/2) + 2.5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247230|NCT02531802|EG007|Reported Event|24-59 Months: ETVAX (1/2) + 5 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247231|NCT02531802|EG008|Reported Event|24-59 Months: ETVAX (1/2) + 10 ug dmLT|24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11286332|NCT02886702|EG002|Reported Event|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11247232|NCT02531802|EG009|Reported Event|24-59 Months: Placebo|"24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247233|NCT02531802|EG010|Reported Event|12-23 Months: ETVAX (1/4)|12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247234|NCT02531802|EG011|Reported Event|12-23 Months: ETVAX (1/2)|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247235|NCT02531802|EG012|Reported Event|12-23 Months: ETVAX (1/2) + 2.5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247236|NCT02531802|EG013|Reported Event|12-23 Months: ETVAX (1/2) + 5 ug dmLT|12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247237|NCT02531802|EG014|Reported Event|12-23 Months: Placebo|"12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247238|NCT02531802|EG015|Reported Event|6-11 Months: ETVAX (1/8)|6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
11247239|NCT02531802|EG016|Reported Event|6-11 Months: ETVAX (1/4)|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247240|NCT02531802|EG017|Reported Event|6-11 Months: ETVAX (1/2)|6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
11247241|NCT02531802|EG018|Reported Event|6-11 Months: ETVAX (1/4) + 2.5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247242|NCT02531802|EG019|Reported Event|6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT|6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
11247243|NCT02531802|EG020|Reported Event|6-11 Month Olds: Placebo|"6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14~Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water"
11247244|NCT02531867|BG000|Baseline|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator's discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
11247245|NCT02531867|FG000|Participant Flow|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator's discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
11247246|NCT02531867|OG000|Outcome|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator's discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
11247247|NCT02531867|EG000|Reported Event|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator's discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
11247248|NCT02531971|BG000|Baseline|Fentanyl Citrate, Then Duragesic®, Then Mylan|Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I), washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (Study Session II), washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session III)
11247249|NCT02531971|BG001|Baseline|Fentanyl Citrate, Then Mylan, Then Duragesic®|Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I), washout at least one week, then wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session II), washout at least one week, then wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (Study Session III)
11247250|NCT02531971|BG002|Baseline|Total|Total of all reporting groups
11247251|NCT02531971|FG000|Participant Flow|Fentanyl Citrate (36 h), Duragesic® (192 h), Mylan (192 h)|Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples were obtained for 0-36 h, washout at least one week, then same volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples were obtained for 0-192 h, washout at least one week, then same volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session IIII) and blood samples obtained for 0-192 h
11247252|NCT02531971|FG001|Participant Flow|Fentanyl Citrate (36 h), Mylan (192 h), Duragesic® (192 h)|Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I) and blood samples obtained for 0-36 h, washout at least one week, then same volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (Study Session II) and blood samples obtained for 0-192 h, washout at least one week, then same volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (Study Session IIII) and blood samples were obtained for 0-192 h
11247253|NCT02531971|OG000|Outcome|Duragesic|Volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 3 days (either Study Session II or Study Session III)
11247254|NCT02531971|OG001|Outcome|Mylan|Volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 3 days (Study Session II or Study Session III)
11247255|NCT02531971|EG000|Reported Event|Fentanyl Citrate|Volunteers received a single-dose of 100 µg fentanyl citrate infusion (Study Session I); blood samples obtained from 0-36 h
11247256|NCT02531971|EG001|Reported Event|Duragesic®|Volunteers wore a Duragesic® fentanyl TDDS (25 µg/h) for 72 h (either Study Session II or Study Session III); blood samples obtained from 0-192 h
11286333|NCT02886715|BG000|Baseline|Test|Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
11247257|NCT02531971|EG002|Reported Event|Mylan Generic Fentanyl|Volunteers wore a Mylan fentanyl TDDS (25 µg/h) for 72 h (either Study Session II or Study Session III); blood samples obtained from 0-192 h
11247258|NCT02532010|BG000|Baseline|Arm A: Pacritinib and Decitiabine|"Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily."
11247259|NCT02532010|BG001|Baseline|Arm B: Pacritinib and Cytarabine|"Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily."
11247260|NCT02532010|BG002|Baseline|Total|Total of all reporting groups
11247261|NCT02532010|FG000|Participant Flow|Arm A: Pacritinib and Decitiabine|"Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily."
11247262|NCT02532010|FG001|Participant Flow|Arm B: Pacritinib and Cytarabine|"Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily."
11247263|NCT02532010|OG000|Outcome|Arm A: Pacritinib and Decitiabine|"Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily."
11247264|NCT02532010|OG001|Outcome|Arm B: Pacritinib and Cytarabine|"Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily."
11247265|NCT02532010|EG000|Reported Event|Arm A: Pacritinib and Decitiabine|"Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily."
11286334|NCT02886715|BG001|Baseline|Reference|TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
11286335|NCT02886715|BG002|Baseline|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286336|NCT02886715|BG003|Baseline|Total|Total of all reporting groups
11247266|NCT02532010|EG001|Reported Event|Arm B: Pacritinib and Cytarabine|"Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.~Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.~Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily."
11247267|NCT02532036|BG000|Baseline|Starter Group|Received 1x10^7 pfu aerosol inhaled MVA85A at day 0.
11247268|NCT02532036|FG000|Participant Flow|Starter Group|Receive 1x10^7 pfu aerosol inhaled MVA85A at day 0.
11247269|NCT02532036|FG001|Participant Flow|Group A|Receive 5x10^7 pfu aerosol inhaled MVA85A
11247270|NCT02532036|OG000|Outcome|Starter Group|Receive 1x10^7 pfu aerosol inhaled MVA85.
11247271|NCT02532036|EG000|Reported Event|Starter Group|Received 1x10^7 pfu aerosol inhaled MVA85A at day 0.
11247272|NCT02532179|BG000|Baseline|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician's discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
11247273|NCT02532179|FG000|Participant Flow|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician's discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
11247274|NCT02532179|OG000|Outcome|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 weight per volume (w/v) glycerinated mouse allergenic extract. Administration of additional dosages were given at study clinician's discretion, up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 w/v, for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation continued until maximum study dose was achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants received one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
11247275|NCT02532179|EG000|Reported Event|Mouse Allergenic Extract|Participants received escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route. The first injection contained 0.05 mL of 1:10,000 concentration of 1:20 w/v glycerinated mouse allergenic extract, with proceeding administration of additional dosage at study clinician's discretion, for up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol for the first 11 weeks of the 24-week treatment with two injections per week, separated by at least 2 days. Dose escalation would continue until maximum study dose is achieved in a maximum of 18 weeks. For the remaining time of the 24-week treatment, participants would receive one injection of investigational agent every 2 weeks and were asked to report any symptoms possibly related to the investigation agent to the study sites.
11247276|NCT02532283|BG000|Baseline|Pimodivir 600 mg Plus Oseltamivir 75 mg|Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
11247277|NCT02532283|BG001|Baseline|Placebo Plus Oseltamivir 75 mg|Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
11247278|NCT02532283|BG002|Baseline|Total|Total of all reporting groups
11247279|NCT02532283|FG000|Participant Flow|Pimodivir 600 mg Plus Oseltamivir 75 mg|Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
11247280|NCT02532283|FG001|Participant Flow|Placebo Plus Oseltamivir 75 mg|Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
11247281|NCT02532283|OG000|Outcome|Elderly Adults (65 to Less Than or Equal to [<=] 85 Years)|Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
11247282|NCT02532283|OG001|Outcome|Non-elderly Adults (18 to <=64 Years)|Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
11247283|NCT02532283|OG000|Outcome|Pimodivir 600 mg Plus Oseltamivir 75 mg|Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
11286337|NCT02886715|FG000|Participant Flow|Test|Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
11247284|NCT02532283|OG001|Outcome|Placebo Plus Oseltamivir 75 mg|Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
11247285|NCT02532283|EG000|Reported Event|Pimodivir 600 mg Plus Oseltamivir 75 mg|Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
11247286|NCT02532283|EG001|Reported Event|Placebo Plus Oseltamivir 75 mg|Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
10820160|NCT00054639|BG000|Baseline|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
11247287|NCT02532374|BG000|Baseline|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
11247288|NCT02532374|FG000|Participant Flow|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
11247289|NCT02532374|OG000|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
11247290|NCT02532374|OG000|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247291|NCT02532374|OG000|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247292|NCT02532374|OG000|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247293|NCT02532374|EG000|Reported Event|Enrolment Period|"All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.~Product test period - from enrolment to admission."
10820161|NCT00054639|FG000|Participant Flow|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
10820162|NCT00054639|OG000|Outcome|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
10820163|NCT00054639|EG000|Reported Event|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
10820164|NCT00054665|BG000|Baseline|Arm A & B: PS-341 and PS-341 & EPOCH|"Part A: PS-341 Alone~1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days"
10820165|NCT00054665|FG000|Participant Flow|Part A: PS-341 Alone|1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
10969661|NCT00906958|BG000|Baseline|All Study Participants|This was a cross-over study, therefore all participants were assigned to both interventions, for one night each, in a randomised order
10820166|NCT00054665|FG001|Participant Flow|Part B: PS-341 & EPOCH|PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
10820167|NCT00054665|OG000|Outcome|Part A: PS-341 Alone|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
10969662|NCT00906958|FG000|Participant Flow|Modified Autoset (Nexus Flow Generator)|AutoSet algorithms measure breathing patterns and respond to increase or decresase pressures to overcome obstructive sleep apnea. The modified AutoSet algorithm contains software updates to better measure and respond to sleep apnea. Participants used this device for one night, followed by the standard AutoSet, in a randomised order
11247294|NCT02532374|EG001|Reported Event|Nicorette® Inhalator Period|Subjects inhaled the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
11247295|NCT02532374|EG002|Reported Event|P3L 50 µg/Puff Period|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247296|NCT02532374|EG003|Reported Event|P3L 80 µg/Puff Period|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247297|NCT02532374|EG004|Reported Event|P3L 150 µg/Puff Period|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
11247298|NCT02532374|EG005|Reported Event|Safety Follow-up Period|All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects.
11247299|NCT02532465|BG000|Baseline|Air-Q|"The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.~Air-Q"
11247300|NCT02532465|BG001|Baseline|I-gel|"The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.~i-gel"
11247301|NCT02532465|BG002|Baseline|Total|Total of all reporting groups
11247302|NCT02532465|FG000|Participant Flow|Air-Q|"The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.~Air-Q"
11247303|NCT02532465|FG001|Participant Flow|I-gel|"The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.~i-gel"
11247304|NCT02532465|OG000|Outcome|Air-Q|"The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.~Air-Q"
11247305|NCT02532465|OG001|Outcome|I-gel|"The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.~i-gel"
11247306|NCT02532465|EG000|Reported Event|Air-Q|"The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.~Air-Q"
11247307|NCT02532465|EG001|Reported Event|I-gel|"The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.~i-gel"
11247308|NCT02532517|BG000|Baseline|CODMAN ENTERPRISE|Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to [<=] 10 millimeters [mm]), arising from a parent vessel with a diameter of greater than or equal to [>=] 2.5 mm and <= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
11247309|NCT02532517|FG000|Participant Flow|CODMAN ENTERPRISE|Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to [<=] 10 millimeters [mm]), arising from a parent vessel with a diameter of greater than or equal to [>=] 2.5 mm and <= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
11247310|NCT02532517|OG000|Outcome|CODMAN ENTERPRISE|Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to [<=] 10 millimeters [mm]), arising from a parent vessel with a diameter of greater than or equal to [>=] 2.5 mm and <= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
11247311|NCT02532517|EG000|Reported Event|CODMAN ENTERPRISE|Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to [<=] 10 millimeters [mm]), arising from a parent vessel with a diameter of greater than or equal to [>=] 2.5 mm and <= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
11247312|NCT02532543|BG000|Baseline|Group A- Allograft, Membrane|"Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane~Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane"
11247313|NCT02532543|BG001|Baseline|Group B- Alloplast, Membrane|"Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane~Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane"
11247314|NCT02532543|BG002|Baseline|Group C- Xenograft, Membrane|"OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane~Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane"
11247315|NCT02532543|BG003|Baseline|Group D- Membrane|"Symbios OsteoShield Collagen Resorbable Membrane~Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane"
11247316|NCT02532543|BG004|Baseline|Total|Total of all reporting groups
11247317|NCT02532543|FG000|Participant Flow|Group A- Allograft, Membrane|"Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane~Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane"
11247318|NCT02532543|FG001|Participant Flow|Group B- Alloplast, Membrane|"Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane~Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane"
11247319|NCT02532543|FG002|Participant Flow|Group C- Xenograft, Membrane|"OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane~Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane"
11247320|NCT02532543|FG003|Participant Flow|Group D- Membrane|"Symbios OsteoShield Collagen Resorbable Membrane~Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane"
11247321|NCT02532543|OG000|Outcome|Group A- Allograft, Membrane|"Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane~Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane"
11247322|NCT02532543|OG001|Outcome|Group B- Alloplast, Membrane|"Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane~Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane"
11247323|NCT02532543|OG002|Outcome|Group C- Xenograft, Membrane|"OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane~Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane"
11247324|NCT02532543|OG003|Outcome|Group D- Membrane|"Symbios OsteoShield Collagen Resorbable Membrane~Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane"
11247325|NCT02532543|EG000|Reported Event|Group A- Allograft, Membrane|"Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane~Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane"
11247326|NCT02532543|EG001|Reported Event|Group B- Alloplast, Membrane|"Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane~Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane"
11247327|NCT02532543|EG002|Reported Event|Group C- Xenograft, Membrane|"OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane~Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane"
11247328|NCT02532543|EG003|Reported Event|Group D- Membrane|"Symbios OsteoShield Collagen Resorbable Membrane~Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane"
11247329|NCT02532556|BG000|Baseline|Electrical Muscle Stimulation Participants|All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis)
11247330|NCT02532556|FG000|Participant Flow|Electrical Muscle Stimulation Participants|All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis)
11247331|NCT02532556|OG000|Outcome|Vastus Lateralis|
11247332|NCT02532556|OG001|Outcome|Rectus Femoris|
11247333|NCT02532556|OG002|Outcome|Vastus Medialis|
11247334|NCT02532556|OG003|Outcome|Gastrocnemius (Medial)|
10969663|NCT00906958|FG001|Participant Flow|VPAP Flow Generator 25|Existing AutoSet algorithm for the treatment of obstructive sleep apnea. Participants used this device for one night, followed by the modified AutoSet algorithm, in a randomised order
11247335|NCT02532556|OG004|Outcome|Gastrocnemius (Lateral)|
11247336|NCT02532556|OG005|Outcome|Tibialis Anterior|
11247337|NCT02532556|OG006|Outcome|Peroneus Longus|
11247338|NCT02532556|EG000|Reported Event|Electrical Muscle Stimulation Participants|All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis)
11247339|NCT02532647|BG000|Baseline|Remimazolam|Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
11247340|NCT02532647|BG001|Baseline|Placebo|Placebo administered in double-blind manner.
11247341|NCT02532647|BG002|Baseline|Midazolam|Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
11247342|NCT02532647|BG003|Baseline|Total|Total of all reporting groups
11247343|NCT02532647|FG000|Participant Flow|Remimazolam|Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
11247344|NCT02532647|FG001|Participant Flow|Placebo|Placebo administered in double-blind manner.
11247345|NCT02532647|FG002|Participant Flow|Midazolam|Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
11247346|NCT02532647|OG000|Outcome|Remimazolam|Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
11247347|NCT02532647|OG001|Outcome|Placebo|Placebo administered in double-blind manner.
11247348|NCT02532647|OG002|Outcome|Midazolam|Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
11247349|NCT02532647|EG000|Reported Event|Remimazolam|Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
11247350|NCT02532647|EG001|Reported Event|Placebo|Placebo administered in double-blind manner.
11247351|NCT02532647|EG002|Reported Event|Midazolam|Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
11247352|NCT02532764|BG000|Baseline|QR-010 SAD 6.25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247353|NCT02532764|BG001|Baseline|QR-010 SAD 12.5 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247354|NCT02532764|BG002|Baseline|QR-010 SAD 25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247355|NCT02532764|BG003|Baseline|QR-010 SAD 50 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11286338|NCT02886715|FG001|Participant Flow|Reference|TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
10820168|NCT00054665|OG001|Outcome|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
10820169|NCT00054665|OG000|Outcome|Part A: PS-341 Alone|Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
11247356|NCT02532764|BG004|Baseline|Placebo SAD|"Placebo (normal saline) administered via inhalation as a single dose~Placebo: Normal Saline"
11247357|NCT02532764|BG005|Baseline|QR-010 MAD 6.25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247358|NCT02532764|BG006|Baseline|QR-010 MAD 12.5 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247359|NCT02532764|BG007|Baseline|QR-010 MAD 25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247360|NCT02532764|BG008|Baseline|QR-010 MAD 50 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
10820170|NCT00054665|OG001|Outcome|Part B: PS-341 & EPOCH|"Part B:~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
11247361|NCT02532764|BG009|Baseline|Placebo MAD|"Placebo (normal saline) administered via inhalation three times weekly for four weeks.~Placebo: Normal Saline"
11247362|NCT02532764|BG010|Baseline|Total|Total of all reporting groups
11247363|NCT02532764|FG000|Participant Flow|QR-010 SAD 6.25mg|QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation
11247364|NCT02532764|FG001|Participant Flow|QR-010 SAD 12.5 mg|QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation
11247365|NCT02532764|FG002|Participant Flow|QR-010 SAD 25 mg|QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation
11247366|NCT02532764|FG003|Participant Flow|QR-010 SAD 50 mg|QR-010 administered via inhalation as a single dose. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation
11247367|NCT02532764|FG004|Participant Flow|Placebo SAD|Placebo (normal saline) administered via inhalation as a single dose Placebo: Normal Saline
11247368|NCT02532764|FG005|Participant Flow|QR-010 MAD 6.25|QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation.
11247369|NCT02532764|FG006|Participant Flow|QR-010 MAD 12.5 mg|QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation.
11247370|NCT02532764|FG007|Participant Flow|QR-010 MAD 25 mg|QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation.
10820171|NCT00054665|EG000|Reported Event|Part A: PS-341 Alone|PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
10822078|NCT00074308|OG000|Outcome|Phase 1 = Dose Escalation|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11247371|NCT02532764|FG008|Participant Flow|QR-010 MAD 50 mg|QR-010 administered via inhalation three times weekly for four weeks. QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalation.
11247372|NCT02532764|FG009|Participant Flow|Placebo MAD|"Placebo (normal saline) administered via inhalation three times weekly for four weeks.~Placebo: Normal Saline"
11247373|NCT02532764|OG000|Outcome|QR-010 SAD 6.25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247374|NCT02532764|OG001|Outcome|QR-010 SAD 12.5 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247375|NCT02532764|OG002|Outcome|QR-010 SAD 25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247376|NCT02532764|OG003|Outcome|QR-010 SAD 50 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247377|NCT02532764|OG004|Outcome|Placebo SAD|"Placebo (normal saline) administered via inhalation as a single dose~Placebo: Normal Saline"
11247378|NCT02532764|OG005|Outcome|QR-010 MAD 6.25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247379|NCT02532764|OG006|Outcome|QR-010 MAD 12.5 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247380|NCT02532764|OG007|Outcome|QR-010 MAD 25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247381|NCT02532764|OG008|Outcome|QR-010 MAD 50 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247382|NCT02532764|OG009|Outcome|Placebo MAD|"Placebo (normal saline) administered via inhalation three times weekly for four weeks.~Placebo: Normal Saline"
11247383|NCT02532764|OG000|Outcome|QR-010 MAD 6.25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247384|NCT02532764|OG001|Outcome|QR-010 MAD 12.5 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247385|NCT02532764|OG002|Outcome|QR-010 MAD 25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
10969664|NCT00906958|OG000|Outcome|Nexus Flow Generator|Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.
10969665|NCT00906958|OG001|Outcome|VPAP Flow Generator 25|Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.
11247386|NCT02532764|OG003|Outcome|QR-010 MAD 50 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247387|NCT02532764|OG004|Outcome|Placebo MAD|"Placebo (normal saline) administered via inhalation three times weekly for four weeks.~Placebo: Normal Saline"
11247388|NCT02532764|EG000|Reported Event|QR-010 SAD 6.25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247389|NCT02532764|EG001|Reported Event|QR-010 SAD 12.5 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247390|NCT02532764|EG002|Reported Event|QR-010 SAD 25 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247391|NCT02532764|EG003|Reported Event|QR-010 SAD 50 mg|"QR-010 administered via inhalation as a single dose~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247392|NCT02532764|EG004|Reported Event|Placebo SAD|"Placebo (normal saline) administered via inhalation as a single dose~Placebo: Normal Saline"
11247393|NCT02532764|EG005|Reported Event|QR-010 MAD 6.25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11247394|NCT02532764|EG006|Reported Event|QR-010 MAD 12.5 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
11286339|NCT02886715|FG002|Participant Flow|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11247395|NCT02532764|EG007|Reported Event|QR-010 MAD 25 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
10820172|NCT00054665|EG001|Reported Event|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days."
10820173|NCT00054691|BG000|Baseline|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
10820174|NCT00054691|FG000|Participant Flow|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
10820175|NCT00054691|OG000|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
10820176|NCT00054691|EG000|Reported Event|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
10820177|NCT00054704|BG000|Baseline|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820178|NCT00054704|BG001|Baseline|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820179|NCT00054704|BG002|Baseline|Total|Total of all reporting groups
11247396|NCT02532764|EG008|Reported Event|QR-010 MAD 50 mg|"QR-010 administered via inhalation three times weekly for four weeks.~QR-010: Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton"
10820180|NCT00054704|FG000|Participant Flow|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820181|NCT00054704|FG001|Participant Flow|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820182|NCT00054704|OG000|Outcome|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820183|NCT00054704|OG001|Outcome|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10822079|NCT00074308|OG000|Outcome|Phase 2 = Dose Expansion|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11247397|NCT02532764|EG009|Reported Event|Placebo MAD|"Placebo (normal saline) administered via inhalation three times weekly for four weeks.~Placebo: Normal Saline"
11286340|NCT02886715|OG000|Outcome|Test|Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
11286341|NCT02886715|OG001|Outcome|Reference|TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
11286342|NCT02886715|OG002|Outcome|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286343|NCT02886715|EG000|Reported Event|Test|Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
10969666|NCT00906958|OG000|Outcome|Nexus Flow Generator|"Participants were randomised for Nexus Flow Generator group for one night.~Nexus Flow Generator: The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment."
11286344|NCT02886715|EG001|Reported Event|Reference|TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
11247398|NCT02532855|BG000|Baseline|Sitagliptin|Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247399|NCT02532855|BG001|Baseline|Dapagliflozin|Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247400|NCT02532855|BG002|Baseline|Total|Total of all reporting groups
11247401|NCT02532855|FG000|Participant Flow|Sitagliptin|Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247402|NCT02532855|FG001|Participant Flow|Dapagliflozin|Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247403|NCT02532855|OG000|Outcome|Sitagliptin|Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247404|NCT02532855|OG001|Outcome|Dapagliflozin|Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247405|NCT02532855|EG000|Reported Event|Sitagliptin|Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247406|NCT02532855|EG001|Reported Event|Dapagliflozin|Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
11247407|NCT02532933|BG000|Baseline|Medialized Dome Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry~DePuy Synthes Attune PS RP"
11247408|NCT02532933|BG001|Baseline|Anatomic Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry~DePuy Synthes Attune PS RP"
11247409|NCT02532933|BG002|Baseline|Total|Total of all reporting groups
11247410|NCT02532933|FG000|Participant Flow|Medialized Dome Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry~DePuy Synthes Attune PS RP"
11247411|NCT02532933|FG001|Participant Flow|Anatomic Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry~DePuy Synthes Attune PS RP"
11247412|NCT02532933|OG000|Outcome|Medialized Dome Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry~DePuy Synthes Attune PS RP"
11247413|NCT02532933|OG001|Outcome|Anatomic Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry~DePuy Synthes Attune PS RP"
11247414|NCT02532933|EG000|Reported Event|Medialized Dome Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry~DePuy Synthes Attune PS RP"
11247415|NCT02532933|EG001|Reported Event|Anatomic Patella|"Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry~DePuy Synthes Attune PS RP"
11247416|NCT02532972|BG000|Baseline|Cochlear Implant Surgery|All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array. Intervention consists of Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
11286345|NCT02886715|EG002|Reported Event|Placebo|Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
11286346|NCT02886728|BG000|Baseline|Filgotinib 200 mg + MTX|Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
10969667|NCT00906958|OG001|Outcome|VPAP Flow Generator 25|"Participants were randomised for VPAP Flow Generator 25 group for one night.~VPAP Flow Generator 25: Exiting VPAP Auto 25 Flow Generator with A10 Algorithm"
11247417|NCT02532972|FG000|Participant Flow|Cochlear Implant Surgery|"All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array~Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery."
11247418|NCT02532972|OG000|Outcome|Cochlear Implant Surgery|"All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array~Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery."
11247419|NCT02532972|EG000|Reported Event|Cochlear Implant Surgery|Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
11247420|NCT02532998|BG000|Baseline|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
11247421|NCT02532998|FG000|Participant Flow|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
11247422|NCT02532998|OG000|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
11247423|NCT02532998|OG001|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
11247424|NCT02532998|OG000|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
11247425|NCT02532998|OG001|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
11247426|NCT02532998|OG000|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
11247427|NCT02532998|OG000|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
11247428|NCT02532998|OG002|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
11247429|NCT02532998|OG003|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
11247430|NCT02532998|EG000|Reported Event|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
11247431|NCT02532998|EG001|Reported Event|Treatment B|Participants received fludrocortisone + AZD9977
11247432|NCT02532998|EG002|Reported Event|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
11247433|NCT02532998|EG003|Reported Event|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
11247434|NCT02533063|BG000|Baseline|Loading + Vibration, Then Loading Only|"In Loading + Vibration intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~In Loading Only control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration."
11247435|NCT02533063|BG001|Baseline|Loading Only, Then Loading + Vibration|"In Loading + Vibration intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~In Loading Only control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration."
11247436|NCT02533063|BG002|Baseline|Total|Total of all reporting groups
11247437|NCT02533063|FG000|Participant Flow|Loading + Vibration, Then Loading Only|"In Loading + Vibration phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~In Loading Only phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.~There will be a four week washout period between the two interventions."
11247438|NCT02533063|FG001|Participant Flow|Loading Only, Then Loading + Vibration|"In Loading + Vibration phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~In Loading Only phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.~There will be a four week washout period between the two interventions."
11247439|NCT02533063|OG000|Outcome|Loading + Vibration|"In Loading + Vibration intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~There will be a four week washout period between the two interventions."
11247440|NCT02533063|OG001|Outcome|Loading Only|"In Loading Only control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week.~There will be a four week washout period between the two interventions."
10820184|NCT00054704|EG000|Reported Event|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820185|NCT00054704|EG001|Reported Event|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
10820186|NCT00054717|BG000|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
10820187|NCT00054717|BG001|Baseline|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
10820188|NCT00054717|BG002|Baseline|Total|Total of all reporting groups
10820189|NCT00054717|FG000|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
10820190|NCT00054717|FG001|Participant Flow|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
10820191|NCT00054717|OG000|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
10820192|NCT00054717|OG001|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
10820193|NCT00054717|EG000|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
10820194|NCT00054717|EG001|Reported Event|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
11286347|NCT02886728|BG001|Baseline|Filgotinib 100 mg + MTX|Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
10820195|NCT00054756|BG000|Baseline|Thyrotropin Releasing Hormone|Subjects receiving TRH (Thyrotropin Releasing Hormone)
10820196|NCT00054756|FG000|Participant Flow|Thyrotropin Releasing Hormone|Subjects receiving TRH (Thyrotropin Releasing Hormone)
10820197|NCT00054756|OG000|Outcome|Thyrotropin Releasing Hormone|Subjects receiving TRH (Thyrotropin Releasing Hormone)
10820198|NCT00054756|EG000|Reported Event|Thyrotropin Releasing Hormone|Subjects receiving TRH (Thyrotropin Releasing Hormone)
10820199|NCT00054847|BG000|Baseline|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
10820200|NCT00054847|BG001|Baseline|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
10820201|NCT00054847|BG002|Baseline|Total|Total of all reporting groups
10820202|NCT00054847|FG000|Participant Flow|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
10820203|NCT00054847|FG001|Participant Flow|Radial Artery Graft|"Radial Artery Graft~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
10820204|NCT00054847|OG000|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
10820205|NCT00054847|OG001|Outcome|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
10820206|NCT00054847|OG000|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
10820207|NCT00054847|OG001|Outcome|Radial Artery Grafts|"Radial Artery Grafts~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
10820208|NCT00054847|OG000|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
10820209|NCT00054847|OG001|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
10820210|NCT00054847|EG000|Reported Event|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
10820211|NCT00054847|EG001|Reported Event|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
10820212|NCT00055237|BG000|Baseline|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820213|NCT00055237|BG001|Baseline|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820214|NCT00055237|BG002|Baseline|Total|Total of all reporting groups
10820215|NCT00055237|FG000|Participant Flow|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820216|NCT00055237|FG001|Participant Flow|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820217|NCT00055237|OG000|Outcome|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820218|NCT00055237|OG000|Outcome|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820219|NCT00055237|EG000|Reported Event|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
10820220|NCT00055471|BG000|Baseline|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
10820221|NCT00055471|BG001|Baseline|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
10820222|NCT00055471|BG002|Baseline|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
11247441|NCT02533063|OG000|Outcome|Loading + Vibration|"In Loading + Vibration intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~In Loading Only control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.~There will be a four week washout period between the two interventions."
11247442|NCT02533063|EG000|Reported Event|Loading + Vibration|"In Loading + Vibration intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. The vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max of 1.0 g.~There will be a four week washout period between the two interventions."
11247443|NCT02533063|EG001|Reported Event|Loading Only|"In Loading Only ocntrol phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week.~There will be a four week washout period between the two interventions."
11247444|NCT02533089|BG000|Baseline|KT Intervention|"Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.~KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network."
11247445|NCT02533089|BG001|Baseline|Control|Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.
11247446|NCT02533089|BG002|Baseline|Total|Total of all reporting groups
11247447|NCT02533089|FG000|Participant Flow|KT Intervention|"Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.~KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network."
11247448|NCT02533089|FG001|Participant Flow|Control|Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.
11247449|NCT02533089|OG000|Outcome|KT Intervention|"Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.~KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network."
11247450|NCT02533089|OG001|Outcome|Control|Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.
11247451|NCT02533089|EG000|Reported Event|KT Intervention|"Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.~KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network."
11247452|NCT02533089|EG001|Reported Event|Control|Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.
11247453|NCT02533167|BG000|Baseline|Skin to Skin|"skin to skin initiated on all consented CS while in the operating room~skin to skin: initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care."
11247454|NCT02533167|FG000|Participant Flow|Skin to Skin|"skin to skin initiated on all consented CS while in the operating room~skin to skin: initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care."
11247455|NCT02533167|OG000|Outcome|Skin to Skin|"skin to skin initiated on all consented CS while in the operating room~skin to skin: initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care."
11247456|NCT02533167|OG000|Outcome|Skin to Skin|"skin to skin initiated on all consented CS while in the operating room~skin to skin: initiating skin to skin in the operating room"
11247457|NCT02533167|EG000|Reported Event|Skin to Skin|"skin to skin initiated on all consented CS while in the operating room~skin to skin: initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care."
11247458|NCT02533180|BG000|Baseline|Enrolled, Did Not Initiate Immunosuppression Withdrawal|Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
11247459|NCT02533180|BG001|Baseline|Initiated Immunosuppression Withdrawal|These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
11247460|NCT02533180|BG002|Baseline|Total|Total of all reporting groups
11247461|NCT02533180|FG000|Participant Flow|Enrolled, Did Not Initiate Immunosuppression Withdrawal|Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
11247462|NCT02533180|FG001|Participant Flow|Initiated Immunosuppression Withdrawal|These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
11247463|NCT02533180|OG000|Outcome|Immunosuppression Withdrawal (ISW)|These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
11247464|NCT02533180|EG000|Reported Event|Enrolled, Did Not Initiate Immunosuppression Withdrawal|Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
11247465|NCT02533180|EG001|Reported Event|Initiated Immunosuppression Withdrawal|These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
11247466|NCT02533258|BG000|Baseline|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
11247467|NCT02533258|FG000|Participant Flow|Axitinib (INLYTA)|Participants diagnosed with advanced renal cell carcinoma (RCC) and received axitinib therapy as per routine clinical practice according to the label-packaging-dosing (LPD) under the physician's prescription were observed for 40 months.
11247468|NCT02533258|OG000|Outcome|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
11247469|NCT02533258|EG000|Reported Event|Axitinib (INLYTA)|Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
11247470|NCT02533375|BG000|Baseline|Participants Receiving Adalimumab|80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
11247471|NCT02533375|FG000|Participant Flow|Participants Receiving Adalimumab|80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
11247472|NCT02533375|OG000|Outcome|Participants Receiving Adalimumab|80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
11247473|NCT02533375|EG000|Reported Event|Participants Receiving Adalimumab|80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
11247474|NCT02533401|BG000|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
11247475|NCT02533401|FG000|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
11247476|NCT02533401|OG000|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
11247477|NCT02533401|EG000|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
10820223|NCT00055471|BG003|Baseline|Total|Total of all reporting groups
10820224|NCT00055471|FG000|Participant Flow|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
11247478|NCT02533427|BG000|Baseline|NGM/EE + SOF/VEL/VOX + VOX (Part A and Part B)|"Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol (NGM/EE) for at least one menstrual cycle received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for one cycle (cycle=28 days).~Part B: Participants continued NGM/EE through Cycle 1 and 2 received sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed dose combination (FDC) 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle=28 days)."
11247479|NCT02533427|FG000|Participant Flow|NGM/EE + SOF/VEL/VOX + VOX (Part A and Part B)|"Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol (NGM/EE) for at least one menstrual cycle received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for one cycle (cycle=28 days).~Part B: Participants continued NGM/EE through Cycle 1 and 2 received sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed dose combination (FDC) 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle=28 days)."
11247480|NCT02533427|OG000|Outcome|Part A: NGM/EE|Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
11247481|NCT02533427|OG001|Outcome|Part B: NGM/EE + SOF/VEL/VOX + VOX|Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).
11247482|NCT02533427|OG000|Outcome|Part B: NGM/EE + SOF/VEL/VOX + VOX|Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).
11247483|NCT02533427|EG000|Reported Event|Part A: NGM/EE|Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for 1 cycle (cycle = 28 days).
11247484|NCT02533427|EG001|Reported Event|Part B: NGM/EE + SOF/VEL/VOX + VOX|Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg orally once daily for 2 cycles (cycle = 28 days).
11247485|NCT02533453|BG000|Baseline|12/24 Weeks Treatment|Exenatide 2mg / 12/24 weeks treatment
11247486|NCT02533453|FG000|Participant Flow|12/24 Weeks Treatment|Exenatide 2mg / 12/24 weeks treatment
11247487|NCT02533453|OG000|Outcome|12/24 Weeks Treatment|Exenatide 2mg / 12/24 weeks treatment
11247488|NCT02533453|EG000|Reported Event|12/24 Weeks Treatment|Exenatide 2mg / 12/24 weeks treatment
11247489|NCT02533466|BG000|Baseline|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247490|NCT02533466|BG001|Baseline|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
11247491|NCT02533466|BG002|Baseline|Total|Total of all reporting groups
11247492|NCT02533466|FG000|Participant Flow|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247493|NCT02533466|FG001|Participant Flow|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247494|NCT02533466|OG000|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
10820225|NCT00055471|FG001|Participant Flow|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
10820226|NCT00055471|FG002|Participant Flow|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
11247495|NCT02533466|OG001|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247496|NCT02533466|OG000|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
11247497|NCT02533466|OG001|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
11247498|NCT02533466|EG000|Reported Event|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247499|NCT02533466|EG001|Reported Event|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
11247500|NCT02533505|BG000|Baseline|Over All|
11247501|NCT02533505|FG000|Participant Flow|Symbicort pMDI/Placebo/Symbicort pMDI/Placebo|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11286348|NCT02886728|BG002|Baseline|Filgotinib 200 mg Monotherapy|Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
11247502|NCT02533505|FG001|Participant Flow|Placebo/Symbicort pMDI/Placebo/Symbicort pMDI|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11247503|NCT02533505|OG000|Outcome|Symbicort pMDI|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11247504|NCT02533505|OG001|Outcome|Placebo|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11247505|NCT02533505|EG000|Reported Event|Symbicort pMDI|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11247506|NCT02533505|EG001|Reported Event|Placebo|The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.
11247507|NCT02533570|BG000|Baseline|Placebo|Intravenous (IV) placebo every 3 weeks for a total of 4 doses
11247508|NCT02533570|BG001|Baseline|Brentuximab Vedotin 0.3 mg/kg|Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
11247509|NCT02533570|BG002|Baseline|Brentuximab Vedotin 0.6 mg/kg|Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
11247510|NCT02533570|BG003|Baseline|Total|Total of all reporting groups
11247511|NCT02533570|FG000|Participant Flow|Placebo|Intravenous (IV) placebo every 3 weeks for a total of 4 doses
11247512|NCT02533570|FG001|Participant Flow|Brentuximab Vedotin 0.3 mg/kg|Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
11247513|NCT02533570|FG002|Participant Flow|Brentuximab Vedotin 0.6 mg/kg|Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
10820227|NCT00055471|OG000|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
10820228|NCT00055471|OG001|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
11247514|NCT02533570|OG000|Outcome|Placebo|Intravenous (IV) placebo every 3 weeks for a total of 4 doses
11247515|NCT02533570|OG001|Outcome|Brentuximab Vedotin 0.3 mg/kg|Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
11247516|NCT02533570|OG002|Outcome|Brentuximab Vedotin 0.6 mg/kg|Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
11247517|NCT02533570|EG000|Reported Event|Placebo|Intravenous (IV) placebo every 3 weeks for a total of 4 doses
11247518|NCT02533570|EG001|Reported Event|Brentuximab Vedotin 0.3 mg/kg|Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
11247519|NCT02533570|EG002|Reported Event|Brentuximab Vedotin 0.6 mg/kg|Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
11247520|NCT02533674|BG000|Baseline|GEM/PM060184 Dose Level I|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level I: 800 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247521|NCT02533674|BG001|Baseline|GEM/PM060184 Dose Level II|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level II: 800 mg/m^2 GEM / 7.0 mg/m^2 PM060184"
11247522|NCT02533674|BG002|Baseline|GEM/PM060184 Dose Level III|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level III: 1000 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247523|NCT02533674|BG003|Baseline|GEM/PM060184 Dose Level IV|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level IV: 1000 mg/m^2 GEM / 8.0 mg/m^2 PM060184"
11247524|NCT02533674|BG004|Baseline|GEM/PM060184 Dose Level V|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level V: 1000 mg/m^2 GEM / 9.0 mg/m^2 PM060184"
11247525|NCT02533674|BG005|Baseline|GEM/PM060184 Dose Level VI|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VI: 1000 mg/m^2 GEM / 9.3 mg/m^2 PM060184"
11247526|NCT02533674|BG006|Baseline|GEM/PM060184 Dose Level VII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VII:1000 mg/m^2 GEM / 10.0 mg/m^2 PM060184"
11247527|NCT02533674|BG007|Baseline|GEM/PM060184 Dose Level VIII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VIII:1000 mg/m^2 GEM / 10.5 mg/m^2 PM060184"
11247528|NCT02533674|BG008|Baseline|Total|Total of all reporting groups
11247529|NCT02533674|FG000|Participant Flow|GEM/PM060184 Dose Level I|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level I: 800 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247530|NCT02533674|FG001|Participant Flow|GEM/PM060184 Dose Level II|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level II: 800 mg/m^2 GEM / 7.0 mg/m^2 PM060184"
11247531|NCT02533674|FG002|Participant Flow|GEM/PM060184 Dose Level III|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level III: 1000 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247532|NCT02533674|FG003|Participant Flow|GEM/PM060184 Dose Level IV|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level IV: 1000 mg/m^2 GEM / 8.0 mg/m^2 PM060184"
11247533|NCT02533674|FG004|Participant Flow|GEM/PM060184 Dose Level V|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level V: 1000 mg/m^2 GEM / 9.0 mg/m^2 PM060184"
11247534|NCT02533674|FG005|Participant Flow|GEM/PM060184 Dose Level VI|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VI: 1000 mg/m^2 GEM / 9.3 mg/m^2 PM060184"
10820229|NCT00055471|OG002|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
11247535|NCT02533674|FG006|Participant Flow|GEM/PM060184 Dose Level VII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VII:1000 mg/m^2 GEM / 10.0 mg/m^2 PM060184"
11247536|NCT02533674|FG007|Participant Flow|GEM/PM060184 Dose Level VIII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VIII:1000 mg/m^2 GEM / 10.5 mg/m^2 PM060184"
11247537|NCT02533674|OG000|Outcome|GEM/PM060184 Dose Level I|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level I: 800 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247538|NCT02533674|OG001|Outcome|GEM/PM060184 Dose Level II|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level II: 800 mg/m^2 GEM / 7.0 mg/m^2 PM060184"
11247539|NCT02533674|OG002|Outcome|GEM/PM060184 Dose Level III|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level III: 1000 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11286349|NCT02886728|BG003|Baseline|MTX Monotherapy|Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
10820230|NCT00055471|EG000|Reported Event|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
10820231|NCT00055471|EG001|Reported Event|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
10820232|NCT00055471|EG002|Reported Event|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
10820233|NCT00055497|BG000|Baseline|DB Placebo|
10820234|NCT00055497|BG001|Baseline|DB Adalimumab 40 mg Every Other Week (Eow)|
11247540|NCT02533674|OG003|Outcome|GEM/PM060184 Dose Level IV|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level IV: 1000 mg/m^2 GEM / 8.0 mg/m^2 PM060184"
11247541|NCT02533674|OG004|Outcome|GEM/PM060184 Dose Level V|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level V: 1000 mg/m^2 GEM / 9.0 mg/m^2 PM060184"
11247542|NCT02533674|OG005|Outcome|GEM/PM060184 Dose Level VI|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VI: 1000 mg/m^2 GEM / 9.3 mg/m^2 PM060184"
11247543|NCT02533674|OG006|Outcome|GEM/PM060184 Dose Level VII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VII:1000 mg/m^2 GEM / 10.0 mg/m^2 PM060184"
11247544|NCT02533674|OG007|Outcome|GEM/PM060184 Dose Level VIII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VIII:1000 mg/m^2 GEM / 10.5 mg/m^2 PM060184"
11247545|NCT02533674|EG000|Reported Event|GEM/PM060184 Dose Level I|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level I: 800 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247546|NCT02533674|EG001|Reported Event|GEM/PM060184 Dose Level II|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level II: 800 mg/m^2 GEM / 7.0 mg/m^2 PM060184"
11247547|NCT02533674|EG002|Reported Event|GEM/PM060184 Dose Level III|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level III: 1000 mg/m^2 GEM / 6.0 mg/m^2 PM060184"
11247548|NCT02533674|EG003|Reported Event|GEM/PM060184 Dose Level IV|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level IV: 1000 mg/m^2 GEM / 8.0 mg/m^2 PM060184"
11247549|NCT02533674|EG004|Reported Event|GEM/PM060184 Dose Level V|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level V: 1000 mg/m^2 GEM / 9.0 mg/m^2 PM060184"
10969668|NCT00906958|EG000|Reported Event|Nexus Flow Generator|Modified AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No Adverse Events were reported during the trial
11247550|NCT02533674|EG005|Reported Event|GEM/PM060184 Dose Level VI|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VI: 1000 mg/m^2 GEM / 9.3 mg/m^2 PM060184"
11247551|NCT02533674|EG006|Reported Event|GEM/PM060184 Dose Level VII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VII:1000 mg/m^2 GEM / 10.0 mg/m^2 PM060184"
11247552|NCT02533674|EG007|Reported Event|GEM/PM060184 Dose Level VIII|"Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.~Administration of study treatment was as follows:~GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:~PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.~Dose Level VIII:1000 mg/m^2 GEM / 10.5 mg/m^2 PM060184"
11247553|NCT02533726|BG000|Baseline|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
11247554|NCT02533726|BG001|Baseline|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
11247555|NCT02533726|BG002|Baseline|Total|Total of all reporting groups
11247556|NCT02533726|FG000|Participant Flow|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
11247557|NCT02533726|FG001|Participant Flow|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
11247558|NCT02533726|OG000|Outcome|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
11247559|NCT02533726|OG001|Outcome|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
11247560|NCT02533726|EG000|Reported Event|Treatment - Optimal Turning|All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
11247561|NCT02533726|EG001|Reported Event|Control - Standard Care|All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
11247562|NCT02533921|BG000|Baseline|Standard of Care|"Usual care as in including both a Primary Care Physician (PCP) and neurologist.~Standard of Care: Usual care defined as including both a PCP and neurologist"
11247563|NCT02533921|BG001|Baseline|Interdisciplinary Outpatient Palliative Care|"Usual care augmented by an outpatient interdisciplinary palliative care team.~Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease."
11247564|NCT02533921|BG002|Baseline|Total|Total of all reporting groups
11247565|NCT02533921|FG000|Participant Flow|Standard of Care|"Usual care as in including both a Primary Care Physician (PCP) and neurologist.~Standard of Care: Usual care defined as including both a PCP and neurologist"
11247566|NCT02533921|FG001|Participant Flow|Interdisciplinary Outpatient Palliative Care|"Usual care augmented by an outpatient interdisciplinary palliative care team.~Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease."
11247567|NCT02533921|OG000|Outcome|Standard of Care|"Usual care as in including both a Primary Care Physician (PCP) and neurologist.~Standard of Care: Usual care defined as including both a PCP and neurologist"
11247568|NCT02533921|OG001|Outcome|Interdisciplinary Outpatient Palliative Care|"Usual care augmented by an outpatient interdisciplinary palliative care team.~Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease."
11247569|NCT02533921|EG000|Reported Event|Standard of Care|"Usual care as in including both a Primary Care Physician (PCP) and neurologist.~Standard of Care: Usual care defined as including both a PCP and neurologist"
11247570|NCT02533921|EG001|Reported Event|Interdisciplinary Outpatient Palliative Care|"Usual care augmented by an outpatient interdisciplinary palliative care team.~Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease."
11247571|NCT02533934|BG000|Baseline|Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11286350|NCT02886728|BG004|Baseline|Total|Total of all reporting groups
10820235|NCT00055497|BG002|Baseline|DB Adalimumab 40 mg Every Week|
10820236|NCT00055497|BG003|Baseline|OL Adalimumab 40 mg Eow|Participants who did not continue at Week 4 are not included in Baseline summary.
11247572|NCT02533934|BG001|Baseline|Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247573|NCT02533934|BG002|Baseline|Total|Total of all reporting groups
11247574|NCT02533934|FG000|Participant Flow|Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247575|NCT02533934|FG001|Participant Flow|Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247576|NCT02533934|OG000|Outcome|Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247577|NCT02533934|OG001|Outcome|Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11286351|NCT02886728|FG000|Participant Flow|Filgotinib 200 mg + MTX|Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
11286352|NCT02886728|FG001|Participant Flow|Filgotinib 100 mg + MTX|Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
10820237|NCT00055497|BG004|Baseline|Total|Total of all reporting groups
10820238|NCT00055497|FG000|Participant Flow|DB Placebo|Double-blind adalimumab placebo every week.
11247578|NCT02533934|EG000|Reported Event|Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247579|NCT02533934|EG001|Reported Event|Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant|The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
11247580|NCT02533999|BG000|Baseline|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
11247581|NCT02533999|BG001|Baseline|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
11247582|NCT02533999|BG002|Baseline|Total|Total of all reporting groups
11247583|NCT02533999|FG000|Participant Flow|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
11247584|NCT02533999|FG001|Participant Flow|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
11247585|NCT02533999|OG000|Outcome|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
11247586|NCT02533999|OG001|Outcome|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
10820239|NCT00055497|FG001|Participant Flow|DB Adalimumab 40 mg Every Other Week (Eow)|Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
10820240|NCT00055497|FG002|Participant Flow|DB Adalimumab 40 mg Every Week (ew)|Double-blind adalimumab 40 mg every week.
10820241|NCT00055497|FG003|Participant Flow|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week.
10820242|NCT00055497|OG000|Outcome|DB Placebo|
10820243|NCT00055497|OG001|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
10820244|NCT00055497|OG002|Outcome|DB Adalimumab 40 mg Every Week (ew)|
11247587|NCT02533999|EG000|Reported Event|Surgical Instrument|"PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down. The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.~PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy."
11247588|NCT02533999|EG001|Reported Event|Electrosurgery|"Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.~Electrosurgery: Surgical method for tonsillectomy and adenoidectomy."
11247589|NCT02534129|BG000|Baseline|Difinsa53 and Aquaphor Arms|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field~Aquaphor: Aquaphor is applied to one half of radiation field"
11247590|NCT02534129|FG000|Participant Flow|Aquaphor|This radiation field treated with aquaphor
11247591|NCT02534129|FG001|Participant Flow|Difinsa53|This radiation field treated with Difinsa53
11247592|NCT02534129|OG000|Outcome|Difinsa 53 Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field"
11247593|NCT02534129|OG001|Outcome|Aquaphor Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Aquaphor: Aquaphor is applied to one half of radiation field"
11247594|NCT02534129|EG000|Reported Event|Difinsa53 Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Difinsa53: Difinsa53 cream is applied to one half of radiation field"
11247595|NCT02534129|EG001|Reported Event|Aquaphor Arm|"Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor~Aquaphor: Aquaphor is applied to one half of radiation field"
11247596|NCT02534285|BG000|Baseline|Control|"Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.~hearing protection: Attenuation of hearing during surgery"
11247597|NCT02534285|BG001|Baseline|Intervention|"Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.~hearing protection: Attenuation of hearing during surgery"
11247598|NCT02534285|BG002|Baseline|Total|Total of all reporting groups
11247599|NCT02534285|FG000|Participant Flow|Control|"Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.~hearing protection: Attenuation of hearing during surgery"
11247600|NCT02534285|FG001|Participant Flow|Intervention|"Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.~hearing protection: Attenuation of hearing during surgery"
11247601|NCT02534285|OG000|Outcome|Control|"Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.~hearing protection: Attenuation of hearing during surgery"
11247602|NCT02534285|OG001|Outcome|Intervention|"Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.~hearing protection: Attenuation of hearing during surgery"
11247603|NCT02534285|EG000|Reported Event|Control|"Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.~hearing protection: Attenuation of hearing during surgery"
11247604|NCT02534285|EG001|Reported Event|Intervention|"Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.~hearing protection: Attenuation of hearing during surgery"
11247605|NCT02534324|BG000|Baseline|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247606|NCT02534324|BG001|Baseline|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247607|NCT02534324|BG002|Baseline|Total|Total of all reporting groups
11247608|NCT02534324|FG000|Participant Flow|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247609|NCT02534324|FG001|Participant Flow|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247610|NCT02534324|OG000|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
10820245|NCT00055497|OG003|Outcome|OL Adalimumab 40 mg Eow|
10820246|NCT00055497|OG000|Outcome|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week
10820247|NCT00055497|OG000|Outcome|Placebo|
11247611|NCT02534324|OG001|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247612|NCT02534324|EG000|Reported Event|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247613|NCT02534324|EG001|Reported Event|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
11247614|NCT02534350|BG000|Baseline|Presatovir|200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
11247615|NCT02534350|BG001|Baseline|Placebo|Tablets administered orally or via NG tube once daily for 14 days
11247616|NCT02534350|BG002|Baseline|Total|Total of all reporting groups
11247617|NCT02534350|FG000|Participant Flow|Presatovir|200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via nasogastric (NG) tube once daily
11247618|NCT02534350|FG001|Participant Flow|Placebo|Tablets administered orally or via NG tube once daily for 14 days
11247619|NCT02534350|OG000|Outcome|Presatovir|200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
10820248|NCT00055497|OG001|Outcome|DB Adalimumab 40 mg Eow|
11247620|NCT02534350|OG001|Outcome|Placebo|Tablets administered orally or via NG tube once daily for 14 days
11247621|NCT02534350|EG000|Reported Event|Presatovir|200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
11247622|NCT02534350|EG001|Reported Event|Placebo|Tablets administered orally or via NG tube once daily for 14 days
11247623|NCT02534493|BG000|Baseline|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
11247624|NCT02534493|FG000|Participant Flow|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
11247625|NCT02534493|OG000|Outcome|Unilateral+Bilateral|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
11247626|NCT02534493|OG001|Outcome|Unilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist.
11247627|NCT02534493|OG002|Outcome|Bilateral Only|The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
11247628|NCT02534493|EG000|Reported Event|Carpal Tunnel Medical Device (CTMD)|"The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period.~If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed."
11247629|NCT02534883|BG000|Baseline|Misoprostol Group|"Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol).~Misoprostol: To be placed vaginally~Baseline characteristics not compiled because of early termination."
10820249|NCT00055497|OG002|Outcome|DB Adalimumab 40 mg ew|
10820250|NCT00055497|OG000|Outcome|OL Adalimumab 40 mg|
10820251|NCT00055497|EG000|Reported Event|DB Placebo|
10820252|NCT00055497|EG001|Reported Event|DB Adalimumab 40 mg Eow|
10820253|NCT00055497|EG002|Reported Event|DB Adalimumab 40 mg ew|
10820254|NCT00055497|EG003|Reported Event|OL Adalimumab 40 mg|
10820255|NCT00055601|BG000|Baseline|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11247630|NCT02534883|BG001|Baseline|Placebo Group|"Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery.~Placebo: To be placed vaginally~Baseline characteristics not compiled because of early termination."
11247631|NCT02534883|BG002|Baseline|Total|Total of all reporting groups
11247632|NCT02534883|FG000|Participant Flow|Misoprostol Group|"Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol).~Misoprostol: To be placed vaginally"
11247633|NCT02534883|FG001|Participant Flow|Placebo Group|"Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery.~Placebo: To be placed vaginally"
11247634|NCT02534883|OG000|Outcome|Group 1|"Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol).~Misoprostol: To be place vaginally"
11247635|NCT02534883|OG001|Outcome|Group 2|"Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.~Placebo: To be placed vaginally"
11247636|NCT02534883|EG000|Reported Event|Misoprostol Group|"Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol).~Misoprostol: To be placed vaginally"
11247637|NCT02534883|EG001|Reported Event|Placebo Group|"Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery.~Placebo: To be placed vaginally"
11247638|NCT02534896|BG000|Baseline|Treatment I: Sunpharma1505 (Low Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247639|NCT02534896|BG001|Baseline|Treatment II: Sunpharma1505 (High Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247640|NCT02534896|BG002|Baseline|Treatment III: Reference1505 and Placebo|solution for injection/infusion Day 1 and 15
11247641|NCT02534896|BG003|Baseline|Total|Total of all reporting groups
11247642|NCT02534896|FG000|Participant Flow|Treatment I : Sunpharma1505 (Low Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247643|NCT02534896|FG001|Participant Flow|Treatment II: Sunpharma1505 (High Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247644|NCT02534896|FG002|Participant Flow|Treatment III: Reference1505 and Placebo|solution for injection/infusion Day 1 and 15
11247645|NCT02534896|OG000|Outcome|Treatment I : Sunpharma1505 (Low Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247646|NCT02534896|OG001|Outcome|Treatment II: Sunpharma1505 (High Dose) and Placebo|solution for injection/infusion Day 1 and 15
11247647|NCT02534896|OG002|Outcome|Treatment III: Reference1505 and Placebo|solution for injection/infusion Day 1 and 15
11247648|NCT02534896|EG000|Reported Event|Treatment I: Sunpharma1505 (Low Dose) and Placebo|Treatment I: Treatment I and Placebo
11247649|NCT02534896|EG001|Reported Event|Treatment II: Sunpharma1505 (High Dose) and Placebo|Treatment II: Treatment II and Placebo
11247650|NCT02534896|EG002|Reported Event|Treatment III: Reference1505 and Placebo|Treatment III: Treatment III and Placebo
11247651|NCT02534935|BG000|Baseline|Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.
11247652|NCT02534935|BG001|Baseline|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.
11247653|NCT02534935|BG002|Baseline|Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
11247654|NCT02534935|BG003|Baseline|Total|Total of all reporting groups
11247655|NCT02534935|FG000|Participant Flow|Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.
11247656|NCT02534935|FG001|Participant Flow|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.
11247657|NCT02534935|FG002|Participant Flow|Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
11247658|NCT02534935|OG000|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247659|NCT02534935|OG001|Outcome|Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247660|NCT02534935|OG002|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247661|NCT02534935|OG003|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247662|NCT02534935|OG004|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247663|NCT02534935|OG005|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247664|NCT02534935|OG002|Outcome|Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.
11247665|NCT02534935|OG003|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247666|NCT02534935|OG004|Outcome|Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.
11247667|NCT02534935|OG005|Outcome|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.
11247668|NCT02534935|OG006|Outcome|Group 3: HAV/Saline (>=12 Months to <18 Months)|Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247669|NCT02534935|OG007|Outcome|Group 3: HAV/Saline (>=18 Months to <24 Months)|Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
11247670|NCT02534935|OG008|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
11247671|NCT02534935|OG000|Outcome|Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.
11247672|NCT02534935|OG001|Outcome|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.
11247673|NCT02534935|OG002|Outcome|Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
11247674|NCT02534935|OG000|Outcome|120-mcg Bivalent rLP2086: Stage 2 Booster Phase|Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.
10820256|NCT00055601|BG001|Baseline|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
10820257|NCT00055601|BG002|Baseline|Total|Total of all reporting groups
10820258|NCT00055601|FG000|Participant Flow|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11247675|NCT02534935|EG000|Reported Event|Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1|Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
11247676|NCT02534935|EG001|Reported Event|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination.
11247677|NCT02534935|EG002|Reported Event|Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
11247678|NCT02534935|EG003|Reported Event|120-mcg Bivalent rLP2086: Stage 2 Booster Phase|Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.
11247679|NCT02534935|EG004|Reported Event|Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up|Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
11247680|NCT02534935|EG005|Reported Event|Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up|Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
11247681|NCT02534935|EG006|Reported Event|Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up|Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
11247682|NCT02535000|BG000|Baseline|Group C (Control)|"subjects who will receive one capsule of placebo before the surgery and being repeated the next day~Placebo: placebo"
11247683|NCT02535000|BG001|Baseline|Group D (Duloxetine)|"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day~Duloxetine: duloxetine 60 mg"
11247684|NCT02535000|BG002|Baseline|Total|Total of all reporting groups
11247685|NCT02535000|FG000|Participant Flow|Group C (Control)|"subjects who will receive one capsule of placebo before the surgery and being repeated the next day~Placebo: placebo"
11247686|NCT02535000|FG001|Participant Flow|Group D (Duloxetine)|"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day~Duloxetine: duloxetine 60 mg"
11247687|NCT02535000|OG000|Outcome|Group C (Control)|"subjects who will receive one capsule of placebo before the surgery and being repeated the next day~Placebo: placebo"
11247688|NCT02535000|OG001|Outcome|Group D (Duloxetine)|"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day~Duloxetine: duloxetine 60 mg"
11247689|NCT02535000|EG000|Reported Event|Group C (Control)|"subjects who will receive one capsule of placebo before the surgery and being repeated the next day~Placebo: placebo"
11247690|NCT02535000|EG001|Reported Event|Group D (Duloxetine)|"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day~Duloxetine: duloxetine 60 mg"
11247691|NCT02535026|BG000|Baseline|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
11247692|NCT02535026|FG000|Participant Flow|Breast Cancer (BC) Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
11247693|NCT02535026|OG000|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
11247694|NCT02535026|OG000|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
11247695|NCT02535026|OG001|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
11247696|NCT02535026|OG000|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
11247697|NCT02535026|OG001|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
11247698|NCT02535026|OG000|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
11247699|NCT02535026|OG001|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
11247700|NCT02535026|OG000|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
11247701|NCT02535026|OG001|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
11247702|NCT02535026|OG002|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
11247703|NCT02535026|OG003|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
11247704|NCT02535026|EG000|Reported Event|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
11247705|NCT02535364|BG000|Baseline|JCAR015|Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
11247706|NCT02535364|FG000|Participant Flow|JCAR015|Participants received up to two intravenous (IV) infusions of JCAR015 separated by 14 to 28 days. In Part A, participants received at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice and/or supportive care. In Part B, eligible participants received two IV doses of JCAR015 CAR T cells. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine.
11247707|NCT02535364|OG000|Outcome|JCAR015|Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
11247708|NCT02535364|EG000|Reported Event|JCAR015|Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
11247709|NCT02535416|BG000|Baseline|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
11247710|NCT02535416|BG001|Baseline|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
11247711|NCT02535416|BG002|Baseline|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
11247712|NCT02535416|BG003|Baseline|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
11247713|NCT02535416|BG004|Baseline|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
11247714|NCT02535416|BG005|Baseline|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
11247715|NCT02535416|BG006|Baseline|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
11247716|NCT02535416|BG007|Baseline|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
11247717|NCT02535416|BG008|Baseline|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
11247718|NCT02535416|BG009|Baseline|Total|Total of all reporting groups
11247719|NCT02535416|FG000|Participant Flow|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
11247720|NCT02535416|FG001|Participant Flow|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
11247721|NCT02535416|FG002|Participant Flow|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
11247722|NCT02535416|FG003|Participant Flow|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
11247723|NCT02535416|FG004|Participant Flow|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
11247724|NCT02535416|FG005|Participant Flow|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
11247725|NCT02535416|FG006|Participant Flow|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
11247726|NCT02535416|FG007|Participant Flow|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
11247727|NCT02535416|FG008|Participant Flow|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
11247728|NCT02535416|OG000|Outcome|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
11247729|NCT02535416|OG001|Outcome|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
11247730|NCT02535416|OG002|Outcome|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
11247731|NCT02535416|OG003|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
11247732|NCT02535416|OG004|Outcome|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
11247733|NCT02535416|OG005|Outcome|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
11247734|NCT02535416|OG006|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
11247735|NCT02535416|OG007|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
11247736|NCT02535416|OG008|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
11247737|NCT02535416|OG000|Outcome|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
11247738|NCT02535416|OG001|Outcome|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
11247739|NCT02535416|OG002|Outcome|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
11247740|NCT02535416|OG003|Outcome|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
11247741|NCT02535416|EG000|Reported Event|ARC-520 Cohort 1|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
11247742|NCT02535416|EG001|Reported Event|ARC-520 Cohort 2A|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
11247743|NCT02535416|EG002|Reported Event|ARC-520 Cohort 2|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
11247744|NCT02535416|EG003|Reported Event|ARC-520 Cohort 3|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
11247745|NCT02535416|EG004|Reported Event|ARC-520 Cohort 4|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
11247746|NCT02535416|EG005|Reported Event|ARC-520 Cohort 5|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
11247747|NCT02535416|EG006|Reported Event|ARC-520 Cohort 6|Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
11247748|NCT02535416|EG007|Reported Event|ARC-520 Cohort 7|Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
11247749|NCT02535416|EG008|Reported Event|ARC-520 Cohort 8|Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
11247750|NCT02535481|BG000|Baseline|Epidermal Graft|Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.
11247751|NCT02535481|BG001|Baseline|Split Thickness Skin Graft|Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
11247752|NCT02535481|BG002|Baseline|Total|Total of all reporting groups
11247753|NCT02535481|FG000|Participant Flow|Epidermal Graft|Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.
11247754|NCT02535481|FG001|Participant Flow|Split Thickness Skin Graft|Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
11247755|NCT02535481|OG000|Outcome|Epidermal Graft|Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.
11247756|NCT02535481|OG001|Outcome|Split Thickness Skin Graft|Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
11247757|NCT02535481|EG000|Reported Event|Epidermal Graft|Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.
11247758|NCT02535481|EG001|Reported Event|Split Thickness Skin Graft|Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
11247759|NCT02535572|BG000|Baseline|FEAST|"Patients will receive the FEAST form of ECT~FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes."
11247760|NCT02535572|BG001|Baseline|RUL UB|"Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)~RUL UB: This is right unilateral ultrabrief ECT, the standard of care."
11247761|NCT02535572|BG002|Baseline|Total|Total of all reporting groups
10969669|NCT00906958|EG001|Reported Event|VPAP Flow Generator 25|Standard AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No adverse events were reported during the trial
10969670|NCT00906971|BG000|Baseline|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
10969671|NCT00906971|BG001|Baseline|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
11247762|NCT02535572|FG000|Participant Flow|FEAST|"Patients will receive the FEAST form of ECT~FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes."
11247763|NCT02535572|FG001|Participant Flow|RUL UB (Right Unilateral Ultrabrief Electroconvulsive Therapy)|"Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)~RUL UB: This is right unilateral ultrabrief ECT, the standard of care."
11247764|NCT02535572|OG000|Outcome|FEAST|"Patients will receive the FEAST form of ECT~FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes."
11247765|NCT02535572|OG001|Outcome|RUL UB|"Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)~RUL UB: This is right unilateral ultrabrief ECT, the standard of care."
11247766|NCT02535572|OG001|Outcome|RUL UB (Right Unilateral Ultrabrief Electroconvulsive Therapy)|"Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)~RUL UB: This is right unilateral ultrabrief ECT, the standard of care."
11247767|NCT02535572|EG000|Reported Event|FEAST|"Patients will receive the FEAST form of ECT~FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes."
11247768|NCT02535572|EG001|Reported Event|RUL UB|"Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)~RUL UB: This is right unilateral ultrabrief ECT, the standard of care."
11247769|NCT02535611|BG000|Baseline|Memantine|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.~Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine."
11247770|NCT02535611|BG001|Baseline|Placebo|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.~Placebo: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks."
11247771|NCT02535611|BG002|Baseline|Total|Total of all reporting groups
11247772|NCT02535611|FG000|Participant Flow|Memantine|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.~Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine."
11247773|NCT02535611|FG001|Participant Flow|Placebo|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.~Placebo: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks."
11247774|NCT02535611|OG000|Outcome|Memantine|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.~Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine."
11247775|NCT02535611|OG001|Outcome|Placebo|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.~Placebo: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks."
11247776|NCT02535611|EG000|Reported Event|Memantine|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.~Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine."
11247777|NCT02535611|EG001|Reported Event|Placebo|"Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.~Placebo: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks."
10969672|NCT00906971|BG002|Baseline|Total|Total of all reporting groups
10969673|NCT00906971|FG000|Participant Flow|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
11247778|NCT02535715|BG000|Baseline|Overall Study|"Two 8 mg ORAMED capsules containing insulin then Three 8mg ORAMED capsules containing insulin then One 16mg ORAMED capsules containing insulin~ORMD-0801 capsules: ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients."
11247779|NCT02535715|FG000|Participant Flow|2 x 8mg Oral Insulin Capsules|"Subject enrolled in study who will be assigned to different interventions for the 3 periods of the study with a 3 day to 4 week interval between the different interventions. For this arm, participants will receive the 2x8mg dose first.~2 x 8mg Oral Insulin Capsules 3 x 8mg Oral Insulin Capsules~1 x 16mg Oral Insulin Capsule"
11247780|NCT02535715|FG001|Participant Flow|3 x 8mg Oral Insulin Capsules|"Subject enrolled in study who will be assigned to different interventions for the 3 periods of the study with a 3 day to 4 week interval between the different interventions. For this arm, participants will receive the 3x8mg dose first.~2 x 8mg Oral Insulin Capsules 3 x 8mg Oral Insulin Capsules~1 x 16mg Oral Insulin Capsule"
11247781|NCT02535715|FG002|Participant Flow|1 X 16mg Oral Insulin Capsule|"Subject enrolled in study who will be assigned to different interventions for the 3 periods of the study with a 3 day to 4 week interval between the different interventions. For this arm, participants will receive the 1 x 16mg dose first.~2 x 8mg Oral Insulin Capsules 3 x 8mg Oral Insulin Capsules~1 x 16mg Oral Insulin Capsule"
11247782|NCT02535715|OG000|Outcome|2X 8mg Oral Insulin Capsules|ORAMED provided 8 mg oral insulin capsules. Two (2) capsules administered at time 0 of the euglycemic clamp
11247783|NCT02535715|OG001|Outcome|3X 8mg Oral Insulin Capsules|ORAMED provided 8 mg oral insulin capsules. Three (3) capsules administered at time 0 of the euglycemic clamp
11247784|NCT02535715|OG002|Outcome|1X 16mg Oral Insulin Capsules|ORAMED provided 16mg oral insulin capsules. One(1) capsule administered at time 0 of the euglycemic clamp
11247785|NCT02535715|OG000|Outcome|Two 8mg ORAMED Capsules Containing Insulin|"Two (2) 8 mg ORAMED capsules containing insulin~ORMD-0801 capsules: ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients."
11247786|NCT02535715|OG001|Outcome|Three 8mg ORAMED Capsules|Three (3) 8mg ORAMED INSULIN CAPSULES containing oral insulin
11247787|NCT02535715|OG002|Outcome|One 16mg ORAMED Capsule|One (1) 16mg ORAMED INSULIN CAPSULE containing oral insulin
11247788|NCT02535715|EG000|Reported Event|2X 8mg Capsules|Adverse event reporting for subjects during the 2X 8mg dosing regimen
10969674|NCT00906971|FG001|Participant Flow|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
11247789|NCT02535715|EG001|Reported Event|3X 8mg Oral Insulin Capsules|Adverse event reporting for subjects during the 3X 8mg dosing regimen
11247790|NCT02535715|EG002|Reported Event|1X 16mg Capsules|Adverse event reporting for subjects during the 1X 16mg dosing regimen
11247791|NCT02535741|BG000|Baseline|Triathlon CR Total Knee System|Progressive data: Primary total knee replacement
11247792|NCT02535741|FG000|Participant Flow|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
11247793|NCT02535741|OG000|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
11247794|NCT02535741|OG000|Outcome|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
11247795|NCT02535741|EG000|Reported Event|Triathlon CR Total Knee System|Triathlon CR Primary total knee replacement
11247796|NCT02535806|BG000|Baseline|Treatment Arm|"Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.~IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.~Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose~Velcade: 4 doses of study drug will be given.~Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8~Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22~Dexamethasone: Days 1-5 and 15-19~Mitoxantrone: Days 1 and 2~Vincristine: Days 1, 8, 15, 22~Pegaspargase: Days 3 and 17"
11247797|NCT02535806|FG000|Participant Flow|Treatment Arm|"Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.~IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.~Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose~Velcade: 4 doses of study drug will be given.~Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8~Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22~Dexamethasone: Days 1-5 and 15-19~Mitoxantrone: Days 1 and 2~Vincristine: Days 1, 8, 15, 22~Pegaspargase: Days 3 and 17"
11247798|NCT02535806|OG000|Outcome|Treatment Arm|"Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.~IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.~Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose~Velcade: 4 doses of study drug will be given.~Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8~Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22~Dexamethasone: Days 1-5 and 15-19~Mitoxantrone: Days 1 and 2~Vincristine: Days 1, 8, 15, 22~Pegaspargase: Days 3 and 17"
11286353|NCT02886728|FG002|Participant Flow|Filgotinib 200 mg Monotherapy|Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
11247799|NCT02535806|EG000|Reported Event|Treatment Arm|"Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.~IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.~Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose~Velcade: 4 doses of study drug will be given.~Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8~Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22~Dexamethasone: Days 1-5 and 15-19~Mitoxantrone: Days 1 and 2~Vincristine: Days 1, 8, 15, 22~Pegaspargase: Days 3 and 17"
11247800|NCT02535949|BG000|Baseline|Tranexamic Acid 2 Gram|"One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247801|NCT02535949|BG001|Baseline|Tranexamic Acid 4 Gram|"One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247802|NCT02535949|BG002|Baseline|Placebo|"Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury~Placebo: Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury"
11247803|NCT02535949|BG003|Baseline|Total|Total of all reporting groups
11247804|NCT02535949|FG000|Participant Flow|Tranexamic Acid 2 Gram|"One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247805|NCT02535949|FG001|Participant Flow|Tranexamic Acid 4 Gram|"One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247806|NCT02535949|FG002|Participant Flow|Placebo|"Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury~Placebo: Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury"
11247807|NCT02535949|OG000|Outcome|Tranexamic Acid 2 Gram|"One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247808|NCT02535949|OG001|Outcome|Tranexamic Acid 4 Gram|"One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247809|NCT02535949|OG002|Outcome|Placebo|"Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury~Placebo: Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury"
11247810|NCT02535949|OG000|Outcome|Tranexamic Acid 2 Gram and 4 Gram|"One time dose IV TXA 2 Grams or 4 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247811|NCT02535949|EG000|Reported Event|Tranexamic Acid 2 Gram|"One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
11247812|NCT02535949|EG001|Reported Event|Tranexamic Acid 4 Gram|"One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury~Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots."
10820259|NCT00055601|FG001|Participant Flow|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11247813|NCT02535949|EG002|Reported Event|Placebo|"Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury~Placebo: Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury"
11247814|NCT02536040|BG000|Baseline|38% Diamine Silver Fluoride|"Topical application of 38% diammine silver fluoride to active cavity~38% diammine silver fluoride: treatment of cavity with study agent"
11247815|NCT02536040|BG001|Baseline|Water|"Topical application of fluoride free water to active cavity~Water: Fluoride free, distilled water"
11247816|NCT02536040|BG002|Baseline|Total|Total of all reporting groups
11247817|NCT02536040|FG000|Participant Flow|38% Diamine Silver Fluoride|"Topical application of 38% diammine silver fluoride to active cavity~38% diammine silver fluoride: treatment of cavity with study agent"
11247818|NCT02536040|FG001|Participant Flow|Water|"Topical application of fluoride free water to active cavity~Water: Fluoride free, distilled water"
11247819|NCT02536040|OG000|Outcome|38% Diamine Silver Fluoride|"Topical application of 38% diammine silver fluoride to active cavity~38% diammine silver fluoride: treatment of cavity with study agent"
11247820|NCT02536040|OG001|Outcome|Water|"Topical application of fluoride free water to active cavity~Water: Fluoride free, distilled water"
11247821|NCT02536040|EG000|Reported Event|38% Diamine Silver Fluoride|"Topical application of 38% diammine silver fluoride to active cavity~38% diammine silver fluoride: treatment of cavity with study agent"
11247822|NCT02536040|EG001|Reported Event|Water|"Topical application of fluoride free water to active cavity~Water: Fluoride free, distilled water"
11247823|NCT02536105|BG000|Baseline|Open-Label: Methylphenidate HCl ER Tablets 1|"During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached.~Methylphenidate HCl ER tablets 1"
11286354|NCT02886728|FG003|Participant Flow|MTX Monotherapy|Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
11247824|NCT02536105|FG000|Participant Flow|All Participants|"Participants received 4 different medications at the following 5 time points.~Open-label phase MPH ER Tab 1~Crossover Placebo~Crossover MPH ER Tab 1~Crossover MPH ER Tab 2~Crossover MPH ER Suspension"
11247825|NCT02536105|OG000|Outcome|Methylphenidate HCl ER Tablets 1|"During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER tablets 1"
11247826|NCT02536105|OG001|Outcome|Placebo|"During the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators.~Placebo"
11247827|NCT02536105|OG002|Outcome|Methylphenidate HCl ER Tablets 2|"During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER tablets 2"
11247828|NCT02536105|OG003|Outcome|Methylphenidate HCl ER for Suspension|"During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER for suspension"
11247829|NCT02536105|EG000|Reported Event|Methylphenidate HCl ER Tablets 1|"During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER tablets 1"
11247830|NCT02536105|EG001|Reported Event|Placebo|"During the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators.~Placebo"
11247831|NCT02536105|EG002|Reported Event|Methylphenidate HCl ER Tablets 2|"During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER tablets 2"
11247832|NCT02536105|EG003|Reported Event|Methylphenidate HCl ER for Suspension|"During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase~Methylphenidate HCl ER for suspension"
11247833|NCT02536196|BG000|Baseline|Intervention|"Embolic Protection with transcatheter aortic valve implantation (TAVI)~Embolic Protection Device: Embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)"
11247834|NCT02536196|BG001|Baseline|Control Arm|"Transcatheter aortic valve implantation (TAVI) without embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)"
11247835|NCT02536196|BG002|Baseline|Roll-In|"Embolic Protection with transcatheter aortic valve implantation (TAVI)~Embolic Protection Device: Embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)~Only used for training / safety. No efficacy measurements"
11247836|NCT02536196|BG003|Baseline|Total|Total of all reporting groups
10820260|NCT00055601|OG000|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11247837|NCT02536196|FG000|Participant Flow|Intervention|"Embolic Protection with transcatheter aortic valve implantation (TAVI)~Embolic Protection Device: Embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)"
11247838|NCT02536196|FG001|Participant Flow|Control Arm|"Transcatheter aortic valve implantation (TAVI) without embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)"
11247839|NCT02536196|FG002|Participant Flow|Roll-in|These are patients that were the initial 2 to 3 patients per site that recieved the device but were used to train physicians but not in the randomized group
11247840|NCT02536196|OG000|Outcome|Intervention|"Embolic Protection with transcatheter aortic valve implantation (TAVI)~Embolic Protection Device: Embolic protection~Transcatheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI)"
11247841|NCT02536196|OG001|Outcome|Control|Without CEP
11247842|NCT02536196|EG000|Reported Event|Intervention|"Embolic Protection with transcatheter aortic valve implantation (TAVI)~Embolic Protection Device: Keystone Heart TriGUARD 3"
11247843|NCT02536196|EG001|Reported Event|Control|The control group received a TAVI but did not receive a cerebral embolic protection device.
11247844|NCT02536196|EG002|Reported Event|Roll In|Patients who received the investigational device - TriGUARD 3 but were used for physician training.
11247845|NCT02536248|BG000|Baseline|Sitagliptin First Then Placebo|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
11247846|NCT02536248|BG001|Baseline|Placebo First Then Sitagliptin|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
11247847|NCT02536248|BG002|Baseline|Total|Total of all reporting groups
11247848|NCT02536248|FG000|Participant Flow|Sitagliptin First Then Placebo|"Sitagliptin 100 mg/d for 6 weeks~Wash-out 14 days~Placebo for 6 weeks"
11247849|NCT02536248|FG001|Participant Flow|Placebo First, Then Sitagliptin|"Placebo for 6 weeks~Wash-out 14 days~Sitagliptin 100 mg/d for 6 weeks"
11247850|NCT02536248|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
11247851|NCT02536248|OG001|Outcome|Placebo|Placebo for 6 weeks
11247852|NCT02536248|EG000|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
11247853|NCT02536248|EG001|Reported Event|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
11247854|NCT02536313|BG000|Baseline|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11247855|NCT02536313|BG001|Baseline|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
11247856|NCT02536313|BG002|Baseline|Total|Total of all reporting groups
11247857|NCT02536313|FG000|Participant Flow|SOF/VEL/VOX|Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX ) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 12 weeks
11247858|NCT02536313|FG001|Participant Flow|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + Ribavirin (RBV) (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
11247859|NCT02536313|OG000|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11247860|NCT02536313|OG001|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
10969675|NCT00906971|OG000|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
11247861|NCT02536313|OG000|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily with food for 12 weeks
11247862|NCT02536313|OG001|Outcome|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet once daily with food for 12 weeks
11247863|NCT02536313|EG000|Reported Event|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks
11247864|NCT02536313|EG001|Reported Event|SOF/VEL/VOX + RBV|SOF/VEL/VOX (400/100/100 mg) tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily for 12 weeks
11247865|NCT02536378|BG000|Baseline|PP (Per Protocol)|Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
11247866|NCT02536378|BG001|Baseline|ITT (Intention to Treat)|Patients who were enrolled in the pivotal phase of the study but had a major protocol deviation are included
11247867|NCT02536378|BG002|Baseline|Total|Total of all reporting groups
11247868|NCT02536378|FG000|Participant Flow|PP (Per Protocol)|Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
11247869|NCT02536378|FG001|Participant Flow|ITT (Intention to Treat)|All patients who were enrolled in the pivotal phase of the study but had major protocol deviations
11247870|NCT02536378|OG000|Outcome|PP (Per Protocol)|Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
11247871|NCT02536378|OG001|Outcome|ITT (Intention to Treat)|All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
11247872|NCT02536378|OG000|Outcome|PP (Per Protocol)|Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.
11247873|NCT02536378|OG001|Outcome|ITT (Intention to Treat)|All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
11247874|NCT02536378|EG000|Reported Event|PP (Per Protocol)|Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
11247875|NCT02536378|EG001|Reported Event|ITT (Intention to Treat)|All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
11286355|NCT02886728|OG000|Outcome|Filgotinib 200 mg + MTX|Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
11286356|NCT02886728|OG001|Outcome|Filgotinib 100 mg + MTX|Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
11286357|NCT02886728|OG002|Outcome|Filgotinib 200 mg Monotherapy|Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
11286358|NCT02886728|OG003|Outcome|MTX Monotherapy|Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
11286359|NCT02886728|EG000|Reported Event|Filgotinib 200 mg + MTX|Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks.
11286360|NCT02886728|EG001|Reported Event|Filgotinib 100 mg + MTX|Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
11286361|NCT02886728|EG002|Reported Event|Filgotinib 200 mg Monotherapy|Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
11286362|NCT02886728|EG003|Reported Event|MTX Monotherapy|Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
11286363|NCT02886923|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed a study lens.
11286364|NCT02886923|FG000|Participant Flow|Hioxilfilcon A (Test)/ Hioxifilcon A (Control)|Subjects that received the Test lens during the first study period and the Control lens during the second study period.
11247876|NCT02536404|BG000|Baseline|Etrasimod 2 mg|Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
11247877|NCT02536404|BG001|Baseline|Placebo|Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
11247878|NCT02536404|BG002|Baseline|Total|Total of all reporting groups
11247879|NCT02536404|FG000|Participant Flow|Etrasimod 2 mg|Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
11247880|NCT02536404|FG001|Participant Flow|Placebo|Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
11247881|NCT02536404|OG000|Outcome|Etrasimod 2 mg|Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.
11247882|NCT02536404|OG001|Outcome|Placebo|Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
11247883|NCT02536404|EG000|Reported Event|Etrasimod 2 mg|Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
11247884|NCT02536404|EG001|Reported Event|Placebo|Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
11247885|NCT02536508|BG000|Baseline|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11247886|NCT02536508|BG001|Baseline|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11247887|NCT02536508|BG002|Baseline|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11247888|NCT02536508|BG003|Baseline|Total|Total of all reporting groups
11247889|NCT02536508|FG000|Participant Flow|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11247890|NCT02536508|FG001|Participant Flow|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11247891|NCT02536508|FG002|Participant Flow|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11247892|NCT02536508|OG000|Outcome|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11247893|NCT02536508|OG001|Outcome|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11247894|NCT02536508|OG002|Outcome|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11247895|NCT02536508|EG000|Reported Event|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11247896|NCT02536508|EG001|Reported Event|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11247897|NCT02536508|EG002|Reported Event|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11247898|NCT02536664|BG000|Baseline|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247899|NCT02536664|BG001|Baseline|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247900|NCT02536664|BG002|Baseline|Total|Total of all reporting groups
11247901|NCT02536664|FG000|Participant Flow|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247902|NCT02536664|FG001|Participant Flow|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247903|NCT02536664|OG000|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247904|NCT02536664|OG001|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247905|NCT02536664|EG000|Reported Event|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247906|NCT02536664|EG001|Reported Event|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
11247907|NCT02536781|BG000|Baseline|Placebol|"Blank gel~Anthocyanin: Anti-inflammation gel"
11247908|NCT02536781|BG001|Baseline|Anthocynin|"Anthocyanin gel~Placebo: Blank gel"
11247909|NCT02536781|BG002|Baseline|Total|Total of all reporting groups
11247910|NCT02536781|FG000|Participant Flow|Placebo|Mucoadhesive gel without any drug or treatment. Apply 2 time daily (Morning and Night)
11247911|NCT02536781|FG001|Participant Flow|Anthocynin|Mucoadhesive gel containing 10% of anthocyanin complex. Apply 2 times daily (Morning and night)
11247912|NCT02536781|OG000|Outcome|Placebol|"Blank gel~Anthocyanin: Anti-inflammation gel"
11247913|NCT02536781|OG001|Outcome|Anthocynin|"Anthocyanin gel~Placebo: Blank gel"
11247914|NCT02536781|EG000|Reported Event|Placebol|"Placebo gel~Placebo gel"
11247915|NCT02536781|EG001|Reported Event|Anthocynin|"Anthocyanin gel~Anti-inflammation gel"
11247916|NCT02536833|BG000|Baseline|0.03 mg SM04690|Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
11247917|NCT02536833|BG001|Baseline|0.07 mg SM04690|Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
11247918|NCT02536833|BG002|Baseline|0.23 mg SM04690|Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
11247919|NCT02536833|BG003|Baseline|Placebo|Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
11247920|NCT02536833|BG004|Baseline|Total|Total of all reporting groups
11247921|NCT02536833|FG000|Participant Flow|0.03 mg SM04690|Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
11247922|NCT02536833|FG001|Participant Flow|0.07 mg SM04690|Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
11247923|NCT02536833|FG002|Participant Flow|0.23 mg SM04690|Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
11247924|NCT02536833|FG003|Participant Flow|Placebo|Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
11247925|NCT02536833|OG000|Outcome|0.03 mg SM04690|Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
11247926|NCT02536833|OG001|Outcome|0.07 mg SM04690|Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
11247927|NCT02536833|OG002|Outcome|0.23 mg SM04690|Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
11247928|NCT02536833|OG003|Outcome|Placebo|Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
11247929|NCT02536833|EG000|Reported Event|0.03 mg SM04690|Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
11247930|NCT02536833|EG001|Reported Event|0.07 mg SM04690|Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
11247931|NCT02536833|EG002|Reported Event|0.23 mg SM04690|Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
11247932|NCT02536833|EG003|Reported Event|Placebo|Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
11247933|NCT02536833|EG004|Reported Event|Other|Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.
11247934|NCT02536846|BG000|Baseline|Second Generation Antipsychotic Drug|"Olanzapine; a single 2.5 mg dose PO daily followed by 5 mg dose PO daily for 14 days~Olanzapine: All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days)."
11247935|NCT02536846|FG000|Participant Flow|Olanzapine|Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
11247936|NCT02536846|OG000|Outcome|Olanzapine|Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
11247937|NCT02536846|OG000|Outcome|Second Generation Antipsychotic Drug|"Olanzapine; a single 2.5 mg dose PO daily followed by 5 mg dose PO daily for 14 days~Olanzapine: All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days)."
11247938|NCT02536846|EG000|Reported Event|Olanzapine|Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
11247939|NCT02536963|BG000|Baseline|PVS Screening and Reference Examination|"All enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit.~Pediatric Vision Scanning device: The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.~All enrolled participants will receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.~Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist."
11247940|NCT02536963|FG000|Participant Flow|PVS Screening|"All enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit.~Pediatric Vision Scanning device: The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.~All enrolled participants will receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.~Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist."
11247941|NCT02536963|OG000|Outcome|PVS Screening and Reference Examination|"All enrolled participants were screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit.~Pediatric Vision Scanning device: The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.~All enrolled participants received a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.~Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist."
11247942|NCT02536963|EG000|Reported Event|PVS Screening and Reference Examination|"All enrolled participants will be screened with the Pediatric Vision Scanner (PVS screening) during a well-child visit to compare whether the results of the PVS match the results of the regular eye examination performed during the well-visit.~Pediatric Vision Scanning device: The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.~All enrolled participants will receive a reference examination performed by a fellowship-trained pediatric ophthalmologist. Results will be compared with PVS screening results.~Reference examination: Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist."
11247943|NCT02536976|BG000|Baseline|Active Treatment|2 weeks single blind placebo followed by 2 weeks double blind 25 mg mirabegron, followed by 10 weeks double blind 50 mg mirabegron
11247944|NCT02536976|BG001|Baseline|Placebo|2 weeks single blind placebo followed by 2 weeks double blind placebo matching 25 mg mirabegron, followed by 10 weeks double blind 50 mg mirabegron
11247945|NCT02536976|BG002|Baseline|Total|Total of all reporting groups
11247946|NCT02536976|FG000|Participant Flow|Active Treatment|Participants received 1 daily placebo tablet matching 25 mg tablets of mirabegron for 2 weeks , followed by 1 daily 25 mg tablet of mirabegron for 2 weeks, followed by 2 daily 25 mg tablets of mirabegron for 10 weeks.
11247947|NCT02536976|FG001|Participant Flow|Placebo|Participants received 1 daily placebo tablet matching 25 mg tablets of mirabegron for 4 weeks , followed by 2 daily placebo tablets matching 25 mg tablets of mirabegron for 10 weeks.
11247948|NCT02536976|OG000|Outcome|Active Treatment|"Due to sample size formal statistics were not performed. Observations tabulated below:~Subject ID 8801 8814 8816 Change +2 +2 -1"
11247949|NCT02536976|OG001|Outcome|Placebo|"Due to sample size formal statistics were not performed. Observations tabulated below:~Subject ID 8805 Change +2"
11247950|NCT02536976|OG000|Outcome|Active|Participants receiving active treatment
11247951|NCT02536976|OG001|Outcome|Placebo|Participants receiving placebo treatment
11247952|NCT02536976|EG000|Reported Event|Active Treatment|Participants received 1 daily placebo tablet matching 25 mg tablets of mirabegron for 2 weeks , followed by 1 daily 25 mg tablet of mirabegron for 2 weeks, followed by 2 daily 25 mg tablets of mirabegron for 10 weeks.
10820261|NCT00055601|OG001|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11247953|NCT02536976|EG001|Reported Event|Placebo|Participants received 1 daily placebo tablet matching 25 mg tablets of mirabegron for 4 weeks , followed by 2 daily placebo tablets matching 25 mg tablets of mirabegron for 10 weeks.
11247954|NCT02537015|BG000|Baseline|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
11247955|NCT02537015|FG000|Participant Flow|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
11247956|NCT02537015|OG000|Outcome|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
11247957|NCT02537015|EG000|Reported Event|13 mg Bimatoprost Ocular Insert|13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
11247958|NCT02537431|BG000|Baseline|Open-Label Burosumab Q4W|1.0 mg/kg Q4W, calculated based on baseline weight and up to a maximum dose of 90 mg.
11247959|NCT02537431|FG000|Participant Flow|Open-Label Burosumab Q4W|1.0 mg/kg burosumab monthly (Q4W), calculated based on baseline weight and up to a maximum dose of 90 mg.
11247960|NCT02537431|OG000|Outcome|Open-Label Burosumab Q4W|1.0 mg/kg burosumab Q4W, calculated based on baseline weight and up to a maximum dose of 90 mg.
11247961|NCT02537431|EG000|Reported Event|Open-Label Burosumab Q4W|1.0 mg/kg burosumab Q4W, calculated based on baseline weight and up to a maximum dose of 90 mg.
11247962|NCT02537444|BG000|Baseline|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100mg administered orally (PO) twice daily BID.
11247963|NCT02537444|BG001|Baseline|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11247964|NCT02537444|BG002|Baseline|Total|Total of all reporting groups
11247965|NCT02537444|FG000|Participant Flow|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100mg administered orally (PO) twice daily BID.
11247966|NCT02537444|FG001|Participant Flow|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11247967|NCT02537444|OG000|Outcome|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100mg administered orally (PO) twice daily.
11247968|NCT02537444|OG001|Outcome|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11247969|NCT02537444|EG000|Reported Event|Arm 1 - Acalabrutinib Monotherapy|Acalabrutinib 100mg administered orally (PO) twice daily (BID).
11247970|NCT02537444|EG001|Reported Event|Arm 2 - Acalabrutinib + Pembrolizumab|Acalabrutinib 100mg plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
11247971|NCT02537522|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the course of the study.
11247972|NCT02537522|FG000|Participant Flow|Test/Control - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.
11247973|NCT02537522|FG001|Participant Flow|Control/Test - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.
11247974|NCT02537522|FG002|Participant Flow|Test/Control - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.
11247975|NCT02537522|FG003|Participant Flow|Control/Test - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
11247976|NCT02537522|OG000|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
11247977|NCT02537522|OG001|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
11247978|NCT02537522|EG000|Reported Event|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
11247979|NCT02537522|EG001|Reported Event|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
11247980|NCT02537574|BG000|Baseline|NTX/BUP|"Oral naltrexone + sublingual buprenorphine~NTX/BUP: Daily doses"
11247981|NCT02537574|BG001|Baseline|NTX/PBO-B|"Oral naltrexone + sublingual placebo~NTX/PBO-B: Daily doses"
11247982|NCT02537574|BG002|Baseline|PBO-N/PBO-B|"Oral placebo naltrexone + sublingual placebo buprenorphine~PBO-N/PBO-B: Daily doses"
11247983|NCT02537574|BG003|Baseline|Total|Total of all reporting groups
11247984|NCT02537574|FG000|Participant Flow|NTX/BUP|"Oral naltrexone + sublingual buprenorphine~NTX/BUP: Daily doses"
11247985|NCT02537574|FG001|Participant Flow|NTX/PBO-B|"Oral naltrexone + sublingual placebo~NTX/PBO-B: Daily doses"
11247986|NCT02537574|FG002|Participant Flow|PBO-N/PBO-B|"Oral placebo naltrexone + sublingual placebo buprenorphine~PBO-N/PBO-B: Daily doses"
11247987|NCT02537574|OG000|Outcome|NTX/BUP|"Oral naltrexone + sublingual buprenorphine~NTX/BUP: Daily doses"
11247988|NCT02537574|OG001|Outcome|NTX/PBO-B|"Oral naltrexone + sublingual placebo~NTX/PBO-B: Daily doses"
11247989|NCT02537574|OG002|Outcome|PBO-N/PBO-B|"Oral placebo naltrexone + sublingual placebo buprenorphine~PBO-N/PBO-B: Daily doses"
11247990|NCT02537574|EG000|Reported Event|NTX/BUP|"Oral naltrexone + sublingual buprenorphine~NTX/BUP: Daily doses"
11247991|NCT02537574|EG001|Reported Event|NTX/PBO-B|"Oral naltrexone + sublingual placebo~NTX/PBO-B: Daily doses"
11247992|NCT02537574|EG002|Reported Event|PBO-N/PBO-B|"Oral placebo naltrexone + sublingual placebo buprenorphine~PBO-N/PBO-B: Daily doses"
11247993|NCT02537717|BG000|Baseline|Overall Study|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact lens. Enfilcon A: contact lens"
11247994|NCT02537717|FG000|Participant Flow|Overall Study|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact lens. Enfilcon A: contact lens"
11247995|NCT02537717|OG000|Outcome|Sapphire Lens|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact lens"
11247996|NCT02537717|OG001|Outcome|Enfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~enfilcon A: contact lens"
11247997|NCT02537717|OG000|Outcome|Overall Study|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: Contact lens. Enfilcon A: contact lens"
11247998|NCT02537717|EG000|Reported Event|Sapphire Lens|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~Sapphire Lens: contact lens"
11247999|NCT02537717|EG001|Reported Event|Enfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.~enfilcon A: contact lens"
11248000|NCT02537730|BG000|Baseline|Overall Participants|Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
11248001|NCT02537730|FG000|Participant Flow|Bioclean MPS VII Combo, Then Aosept Clearcare Combo|"Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
11248002|NCT02537730|FG001|Participant Flow|Aosept Clearcare Combo, Then Bioclean MPS VII Combo|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
11248003|NCT02537730|OG000|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
11248004|NCT02537730|OG001|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
11248005|NCT02537730|EG000|Reported Event|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
11248006|NCT02537730|EG001|Reported Event|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
11248007|NCT02537873|BG000|Baseline|Arm 1: Lorcaserin and Cocaine IV|"Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.~Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions"
11248008|NCT02537873|BG001|Baseline|Arm 2: Placebo Comparator and Cocaine IV|"Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions~Placebo comparator: Dextrose in gelatin capsule"
11248009|NCT02537873|BG002|Baseline|Total|Total of all reporting groups
11248010|NCT02537873|FG000|Participant Flow|Arm 1: Lorcaserin and Cocaine IV|"Test Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.~Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions"
11248011|NCT02537873|FG001|Participant Flow|Arm 2: Placebo Comparator and Cocaine IV|"Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions~Placebo comparator: Dextrose in gelatin capsule"
11248012|NCT02537873|OG000|Outcome|Arm 1: Lorcaserin and Cocaine IV|"Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.~Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions"
11248013|NCT02537873|OG001|Outcome|Arm 2: Placebo Comparator and Cocaine IV|"Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions~Placebo comparator: Dextrose in gelatin capsule"
11248014|NCT02537873|OG000|Outcome|Arm 1: Lorcaserin and Cocaine IV|"Test Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.~Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions"
11248015|NCT02537873|EG000|Reported Event|Arm 1: Lorcaserin and Cocaine IV|"Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.~Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions"
11248016|NCT02537873|EG001|Reported Event|Arm 2: Placebo Comparator and Cocaine IV|"Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.~Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions~Placebo comparator: Dextrose in gelatin capsule"
11248017|NCT02537951|BG000|Baseline|AFI Intensity in Healthy Volunteers|"10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope~AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities~After AFI intensity measurements, the same experiment will be repeated one hour after application of lidocaine/prilocaine creme~After the negative control experiment using lidocaine/prilocaine creme, AFI intensity measurements will be repeated one week after application of a capsaicin 8% patch (second negative control experiment)"
11248018|NCT02537951|FG000|Participant Flow|10 Healthy Volunteers|"10 healthy volunteers underwent three procedures, always in the same order:~baseline AFI measurements~application of lidocaine/prilocaine creme, 1 hour later followed by AFI measurements~application of capsaicin patches, 1 week later followed by AFI measurements"
11248019|NCT02537951|OG000|Outcome|AFI Intensity in Healthy Volunteers|"10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope~AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities"
11248020|NCT02537951|OG001|Outcome|Negative Control 1: Lidocaine/Prilocaine|"10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1hour after application of lidocaine/prilocaine creme (negative control 1)~negative control 1: lidocaine/prilocaine: measurement of AFI intensities following lidocaine/prilocaine cream"
11248021|NCT02537951|OG002|Outcome|Negative Control 2: 8% Capsaicin|"-10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1week after application of an 8% capsaicin patch (negative control 2)~negative control 2: 8% capsaicin: measurement of AFI intensities following 8% capsaicin patch"
11248022|NCT02537951|EG000|Reported Event|AFI Intensity in Healthy Volunteers|10 healthy volunteers-AFI intensity measurements
11248023|NCT02537951|EG001|Reported Event|Negative Control 1: Lidocaine/Prilocaine|10 healthy volunteers-lidocaine/prilocaine creme, one hour lat
11248024|NCT02537951|EG002|Reported Event|Negative Control 2: 8% Capsaicin|10 healthy volunteers-capsaicin patch (2 hours after lidocaine
11248025|NCT02538016|BG000|Baseline|Tolvaptan|"This was a single arm, unblinded study. All participants received half of the recommended dose (weight-dependent) on Days 1 through 4 and then the full recommended dose (weight-dependent) on Days 5 through 8~Example of Dosing Schedule by Weight:~Participant Weight is between: 12.5 kg -37.49 kg Then their Dose on Days 1-4 = 7.5mg (.6mg/kg -.2mg/kg) Dose on Days 5-8 is doubled = 15mg (1.2mg/kg - .4mg/kg) Maximum dose administered was 60 mg."
11248026|NCT02538016|FG000|Participant Flow|Tolvaptan|"This was a single arm, unblinded study. All participants received half of the recommended dose (weight-dependent) on Days 1 through 4 and then the full recommended dose (weight-dependent) on Days 5 through 8~Example of Dosing Schedule by Weight:~Participant Weight is between: 12.5 kg -37.49 kg Then their Dose on Days 1-4 = 7.5mg (.6mg/kg -.2mg/kg) Dose on Days 5-8 is doubled = 15mg (1.2mg/kg - .4mg/kg)~Maximum dose administered was 60 mg."
11248027|NCT02538016|OG000|Outcome|Tolvaptan|Tolvaptan.
11248028|NCT02538016|EG000|Reported Event|Tolvaptan|Tolvaptan.
11248029|NCT02538029|BG000|Baseline|Phase 1|Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
11248030|NCT02538029|BG001|Baseline|Phase 2: Dual Task|This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
11248031|NCT02538029|BG002|Baseline|Phase 2: Single Task|This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
11248032|NCT02538029|BG003|Baseline|Total|Total of all reporting groups
11248033|NCT02538029|FG000|Participant Flow|Phase 1|Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
11248034|NCT02538029|FG001|Participant Flow|Phase 2: Dual Task|This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
11248035|NCT02538029|FG002|Participant Flow|Phase 2: Single Task|This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
11248036|NCT02538029|OG000|Outcome|Phase 1|Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
11248037|NCT02538029|OG001|Outcome|Phase 2: Dual Task|This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
11248038|NCT02538029|OG002|Outcome|Phase 2: Single Task|This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
11248039|NCT02538029|OG000|Outcome|Phase 2: Dual Task|This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
11248040|NCT02538029|OG001|Outcome|Phase 2: Single Task|This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
11248041|NCT02538029|EG000|Reported Event|Phase 1|Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
11248042|NCT02538029|EG001|Reported Event|Phase 2: Dual Task|This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
11248043|NCT02538029|EG002|Reported Event|Phase 2: Single Task|This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
11248044|NCT02538042|BG000|Baseline|MCE+|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248045|NCT02538042|BG001|Baseline|MCE- (Control)|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248046|NCT02538042|BG002|Baseline|Total|Total of all reporting groups
11248047|NCT02538042|FG000|Participant Flow|MCE+|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248048|NCT02538042|FG001|Participant Flow|MCE- (Control)|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248049|NCT02538042|OG000|Outcome|MCE+|"Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.~SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio"
11248050|NCT02538042|OG001|Outcome|MCE- (Control)|"Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.~SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei"
11248051|NCT02538042|OG000|Outcome|MCE+|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248052|NCT02538042|OG001|Outcome|MCE- (Control)|Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
11248053|NCT02538042|EG000|Reported Event|MCE+|"Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.~SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio"
11248054|NCT02538042|EG001|Reported Event|MCE- (Control)|"Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.~Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.~SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei"
11248055|NCT02538094|BG000|Baseline|All Participants|Transcranial direct current stimulation using Anodal stimulation over the area of interest or sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.
11248056|NCT02538094|FG000|Participant Flow|Sham tDCS First|Participants received sham tDCS first and then active anodal tDCS after washout.
11248057|NCT02538094|FG001|Participant Flow|Active Anodal tDCS First|Participants received active anodal tDCS first and then sham tDCS after washout.
11248058|NCT02538094|OG000|Outcome|Sham tDCS|Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.
11248059|NCT02538094|OG001|Outcome|Active Anodal tDCS|Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.
11248060|NCT02538094|EG000|Reported Event|Sham tDCS|Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus
11248061|NCT02538094|EG001|Reported Event|Active Anodal tDCS|Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.
11248062|NCT02538107|BG000|Baseline|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248063|NCT02538107|FG000|Participant Flow|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248064|NCT02538107|OG000|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248065|NCT02538107|OG000|Outcome|Living Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'living donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248066|NCT02538107|OG001|Outcome|Cadaveric Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248067|NCT02538107|OG000|Outcome|Inflammatory Diseases Present-Kidney Transplant Participants|Participants with chronic kidney disease and presence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11213462|NCT02286726|OG000|Outcome|Arm I (Lower-dose (50 Units/m^2) CPX-351)|"Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213463|NCT02286726|OG001|Outcome|Arm II (Intermediate-dose (75 Units/m^2) CPX-351)|"Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213464|NCT02286726|OG002|Outcome|Arm III (Standard-dose (100 Units/m^2) CPX-351)|"Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213465|NCT02286726|EG000|Reported Event|Arm I (Lower-dose (50 Units/m^2) CPX-351)|"Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213466|NCT02286726|EG001|Reported Event|Arm II (Intermediate-dose (75 Units/m^2) CPX-351)|"Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213467|NCT02286726|EG002|Reported Event|Arm III (Standard-dose (100 Units/m^2) CPX-351)|"Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV"
11213468|NCT02286843|BG000|Baseline|HER2-targeted PET/CT|Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
11213469|NCT02286843|FG000|Participant Flow|HER2-targeted PET/CT|Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
11213470|NCT02286843|OG000|Outcome|HER2-targeted PET/CT|Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
11213471|NCT02286843|EG000|Reported Event|HER2-targeted PET/CT|Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
11213472|NCT02286895|BG000|Baseline|Group A (Without Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213473|NCT02286895|BG001|Baseline|Group B (With Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).~pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213474|NCT02286895|BG002|Baseline|Total|Total of all reporting groups
11213475|NCT02286895|FG000|Participant Flow|Group A (Without Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213476|NCT02286895|FG001|Participant Flow|Group B (With Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).~pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213477|NCT02286895|OG000|Outcome|Group A (Without Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11248068|NCT02538107|OG001|Outcome|Inflammatory Diseases Absent-Kidney Transplant Participants|Participants with chronic kidney disease and absence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248069|NCT02538107|OG000|Outcome|Glomerulonephritis-Kidney Transplant Participants|Participants with glomerulonephritis as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248070|NCT02538107|OG001|Outcome|Other Reason-Kidney Transplant Participants|Participants with unspecified other reasons as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248071|NCT02538107|OG000|Outcome|Absence of Acute Bleeding-Kidney Transplant Participants|Participants with absence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248072|NCT02538107|OG001|Outcome|Presence of Acute Bleeding-Kidney Transplant Participants|Participants with presence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248073|NCT02538107|OG000|Outcome|GFR (<30 mL/Min)-Kidney Transplant Participants|Participants with GFR <30 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248074|NCT02538107|OG001|Outcome|GFR (30-60 mL/Min)-Kidney Transplant Participants|Participants with GFR in the range of 30-60 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248075|NCT02538107|EG000|Reported Event|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
11248076|NCT02538341|BG000|Baseline|Zoster Vaccine Live (Zostavax)|"Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Herpes Zoster Vaccine"
11248077|NCT02538341|BG001|Baseline|Placebo Normal Saline|"Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Placebo"
11248078|NCT02538341|BG002|Baseline|Total|Total of all reporting groups
11248079|NCT02538341|FG000|Participant Flow|Zoster Vaccine Live (Zostavax)|"Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Herpes Zoster Vaccine"
11248080|NCT02538341|FG001|Participant Flow|Placebo Normal Saline|"Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Placebo"
11248081|NCT02538341|OG000|Outcome|Zoster Vaccine Live (Zostavax)|"Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Herpes Zoster Vaccine"
11248082|NCT02538341|OG001|Outcome|Placebo Normal Saline|"Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Placebo"
11248083|NCT02538341|EG000|Reported Event|Zoster Vaccine Live (Zostavax)|"Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Herpes Zoster Vaccine"
11248084|NCT02538341|EG001|Reported Event|Placebo Normal Saline|"Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.~Placebo"
11248085|NCT02538354|BG000|Baseline|Riboflavin Supplementation in Quiescent Disease|"Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248086|NCT02538354|BG001|Baseline|Riboflavin Supplementation in Active Disease|"Group 2 (n=42) will consist of patients with active disease.~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248087|NCT02538354|BG002|Baseline|Total|Total of all reporting groups
11248088|NCT02538354|FG000|Participant Flow|Riboflavin Supplementation in Quiescent Disease|"Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248089|NCT02538354|FG001|Participant Flow|Riboflavin Supplementation in Active Disease|"Group 2 (n=42) will consist of patients with active disease.~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
10820262|NCT00055601|EG000|Reported Event|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
10969676|NCT00906971|OG001|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
11248090|NCT02538354|OG000|Outcome|Riboflavin Supplementation in Quiescent Disease|"Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248091|NCT02538354|OG001|Outcome|Riboflavin Supplementation in Active Disease|"Group 2 (n=42) will consist of patients with active disease.~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248092|NCT02538354|EG000|Reported Event|Riboflavin Supplementation in Quiescent Disease|"Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248093|NCT02538354|EG001|Reported Event|Riboflavin Supplementation in Active Disease|"Group 2 (n=42) will consist of patients with active disease.~Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks"
11248094|NCT02538419|BG000|Baseline|Peer Support|"Participants randomized to this arm will receive support from a 'Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.~Peer Support"
11248095|NCT02538419|BG001|Baseline|Individual Education|"Participants randomized to this arm will receive individual support and education from a trained investigator.~Individual Education"
11248096|NCT02538419|BG002|Baseline|Total|Total of all reporting groups
11248097|NCT02538419|FG000|Participant Flow|Peer Support|"Participants randomized to this arm will receive support from a 'Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.~Peer Support"
11248098|NCT02538419|FG001|Participant Flow|Individual Education|"Participants randomized to this arm will receive individual support and education from a trained investigator.~Individual Education"
11248099|NCT02538419|OG000|Outcome|Peer Support|"Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.~Peer Support"
10820263|NCT00055601|EG001|Reported Event|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
11248100|NCT02538419|OG001|Outcome|Individual Education|"Participants randomized to this arm will receive individual support and education from a trained investigator.~Individual Education"
11248101|NCT02538419|EG000|Reported Event|Peer Support|"Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.~Peer Support"
11248102|NCT02538419|EG001|Reported Event|Individual Education|"Participants randomized to this arm will receive individual support and education from a trained investigator.~Individual Education"
11248103|NCT02538471|BG000|Baseline|Arm 1 - Study Drug & Radiation Therapy|"Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet.~The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring.~Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment.~Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week.~Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) ."
11248104|NCT02538471|FG000|Participant Flow|Arm 1 - Study Drug & Radiation Therapy|"Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet.~The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring.~Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment.~Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week.~Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) ."
11248105|NCT02538471|OG000|Outcome|Arm 1 - Study Drug & Radiation Therapy|"Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet.~The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring.~Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment.~Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week.~Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) ."
11248106|NCT02538471|EG000|Reported Event|Arm 1 - Study Drug & Radiation Therapy|"Study Drug: Enrolled patients will receive 300 mg/day of LY2157299. LY2157299 will be administered as an oral drug tablet.~The study drug will be administered orally on a 28-day cycle (1 cycle=28 days), every 2 weeks, or 14 days on / 14 days off. Blood samples will be obtained at baseline, and weeks 2, 6 and 15 for immune monitoring.~Radiation therapy : Patients will receive Radiation therapy to a metastatic site at a dose of 7.5 Gy, given consecutively on days 1, 3 and 5, during Week 1 of their treatment.~Radiation therapy: Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week.~Study Drug: Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) ."
11248107|NCT02538523|BG000|Baseline|Erchonia FX-635|"The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248108|NCT02538523|BG001|Baseline|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248109|NCT02538523|BG002|Baseline|Total|Total of all reporting groups
11248110|NCT02538523|FG000|Participant Flow|Erchonia FX-635|"The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248111|NCT02538523|FG001|Participant Flow|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248112|NCT02538523|OG000|Outcome|Erchonia FX-635|"The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248113|NCT02538523|OG001|Outcome|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248114|NCT02538523|EG000|Reported Event|Erchonia FX-635|"The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.~Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248115|NCT02538523|EG001|Reported Event|Placebo Laser|"The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week."
11248116|NCT02538614|BG000|Baseline|Phase 1b: Idelalisib + BI 836826|Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
11248117|NCT02538614|FG000|Participant Flow|Phase 1b: Idelalisib + BI 836826|Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
11248118|NCT02538614|OG000|Outcome|Phase 1b: Idelalisib + BI 836826|Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
11248119|NCT02538614|OG000|Outcome|Phase 2: Idelalisib + BI 836826|"Phase 1b-Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.~Phase 2 did not occur."
11248120|NCT02538614|OG000|Outcome|Phase 1b and 2: Idelalisib + BI 836826|"Phase 1b-Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.~Phase 2 did not occur."
11248121|NCT02538614|EG000|Reported Event|Phase 1b: Idelalisib + BI 836826|Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
11248122|NCT02538679|BG000|Baseline|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
11248123|NCT02538679|BG001|Baseline|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248124|NCT02538679|BG002|Baseline|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248125|NCT02538679|BG003|Baseline|Total|Total of all reporting groups
11248126|NCT02538679|FG000|Participant Flow|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
11248127|NCT02538679|FG001|Participant Flow|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248128|NCT02538679|FG002|Participant Flow|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248129|NCT02538679|OG000|Outcome|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
11248130|NCT02538679|OG001|Outcome|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248131|NCT02538679|OG002|Outcome|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248132|NCT02538679|EG000|Reported Event|PLACEBO|"No TAP block performed~Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed"
11248133|NCT02538679|EG001|Reported Event|US TAP Bupivacaine/Epinephrine|"Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
11248134|NCT02538679|EG002|Reported Event|Lap TAP Bupivacaine/Epinephrine|"Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.~Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane."
10969677|NCT00906971|EG000|Reported Event|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
11248135|NCT02538783|BG000|Baseline|Control|Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
11248136|NCT02538783|BG001|Baseline|Escalating Lottery|"Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.~Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11248137|NCT02538783|BG002|Baseline|Total|Total of all reporting groups
11248138|NCT02538783|FG000|Participant Flow|Control|Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
11248139|NCT02538783|FG001|Participant Flow|Escalating Lottery|"Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.~Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11248140|NCT02538783|OG000|Outcome|Control|Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
11286365|NCT02886923|FG001|Participant Flow|Hioxilfilcon A (Control)/ Hioxifilcon A (Test)|Subjects that were received the Control lens during the first study period and the Test lens during the second stud period.
11286366|NCT02886923|OG000|Outcome|Hioxifilcon A (Test)|Subjects that wore the Test lens in either the first or second period of the study.
10969678|NCT00906971|EG001|Reported Event|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
11248141|NCT02538783|OG001|Outcome|Escalating Lottery|"Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.~Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11248142|NCT02538783|EG000|Reported Event|Control|Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
11248143|NCT02538783|EG001|Reported Event|Escalating Lottery|"Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.~Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail."
11248144|NCT02538900|BG000|Baseline|Group 1|"Low-intensity, self-paced walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248145|NCT02538900|BG001|Baseline|Group 2|"Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248146|NCT02538900|BG002|Baseline|Group 3|"Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.~Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic."
11248147|NCT02538900|BG003|Baseline|Total|Total of all reporting groups
11248148|NCT02538900|FG000|Participant Flow|Group 1|"Low-intensity, self-paced walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248149|NCT02538900|FG001|Participant Flow|Group 2|"Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248150|NCT02538900|FG002|Participant Flow|Group 3|"Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.~Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic."
11248151|NCT02538900|OG000|Outcome|Group 1|"Low-intensity, self-paced walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
10820264|NCT00055692|BG000|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11248152|NCT02538900|OG001|Outcome|Group 2|"Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248153|NCT02538900|OG002|Outcome|Group 3|"Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.~Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic."
11248154|NCT02538900|EG000|Reported Event|Group 1|"Low-intensity, self-paced walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248155|NCT02538900|EG001|Reported Event|Group 2|"Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.~Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach."
11248156|NCT02538900|EG002|Reported Event|Group 3|"Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.~Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic."
11248157|NCT02538965|BG000|Baseline|Lenalidomide|Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
11248158|NCT02538965|FG000|Participant Flow|Lenalidomide|Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
11248159|NCT02538965|OG000|Outcome|Lenalidomide|Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
11248160|NCT02538965|EG000|Reported Event|Lenalidomide|Participants received oral lenalidomide (capsules or suspension) at 2 mg/kg/day with a maximum dose of 70 mg/day for the first 21 days of each 28-day treatment cycle up to a maximum of 12 cycles of study treatment unless there was the development of a toxicity or adverse event (AE), death, withdrawal by parent/guardian of participant, lost to follow-up, pregnancy, non-compliance with investigational product (IP), physician decision, protocol violation or other reason. Upon completion or discontinuation of study treatment, participants entered the follow-up period for up to 5 years.
11248161|NCT02539108|BG000|Baseline|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248162|NCT02539108|BG001|Baseline|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248163|NCT02539108|BG002|Baseline|Total|Total of all reporting groups
11248164|NCT02539108|FG000|Participant Flow|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11286367|NCT02886923|OG001|Outcome|Hioxifilcon A (Control)|Subjects that wore the Control lens in either the first or second period of the study.
11248165|NCT02539108|FG001|Participant Flow|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248166|NCT02539108|OG000|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248167|NCT02539108|OG001|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248168|NCT02539108|EG000|Reported Event|6 to <36 Months of Age|Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248169|NCT02539108|EG001|Reported Event|3 to <9 Years of Age|Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
11248170|NCT02539134|BG000|Baseline|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
11248171|NCT02539134|BG001|Baseline|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
11248172|NCT02539134|BG002|Baseline|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
11248173|NCT02539134|BG003|Baseline|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
11248174|NCT02539134|BG004|Baseline|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
11248175|NCT02539134|BG005|Baseline|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11248176|NCT02539134|BG006|Baseline|Total|Total of all reporting groups
11248177|NCT02539134|FG000|Participant Flow|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
11248178|NCT02539134|FG001|Participant Flow|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
11248179|NCT02539134|FG002|Participant Flow|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
11248180|NCT02539134|FG003|Participant Flow|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
11248181|NCT02539134|FG004|Participant Flow|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
11248182|NCT02539134|FG005|Participant Flow|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11248183|NCT02539134|OG000|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
11248184|NCT02539134|OG001|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
11248185|NCT02539134|OG002|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
11248186|NCT02539134|OG003|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
11248187|NCT02539134|OG004|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
11248188|NCT02539134|OG005|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11248189|NCT02539134|OG000|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
11248190|NCT02539134|OG001|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
11248191|NCT02539134|OG002|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
10820265|NCT00055692|FG000|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11248192|NCT02539134|OG003|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
11248193|NCT02539134|OG004|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11248194|NCT02539134|EG000|Reported Event|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
11248195|NCT02539134|EG001|Reported Event|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
11248196|NCT02539134|EG002|Reported Event|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
11248197|NCT02539134|EG003|Reported Event|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
11248198|NCT02539134|EG004|Reported Event|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
11248199|NCT02539134|EG005|Reported Event|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11286368|NCT02886923|EG000|Reported Event|Hioxifilcon A (Test)|Subjects that wore the Test lens in either the first or second period of the study.
11286369|NCT02886923|EG001|Reported Event|Hioxifilcon A (Control)|Subjects that wore the Control lens in either the first or second period of the study.
11248200|NCT02539342|BG000|Baseline|Caphosol Arm|"Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a diary to record symptoms of oral mucositis.~Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:~Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.~o Participants may increase the use to 6 times per day if you have symptoms of mucositis.~Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.~For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.~For patients unable to successfu"
11248201|NCT02539342|BG001|Baseline|Control Arm|"Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later)~Biotene: • Use 5 to 10 mL of Biotene to swish and spit~o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab."
11248202|NCT02539342|BG002|Baseline|Total|Total of all reporting groups
11248203|NCT02539342|FG000|Participant Flow|Caphosol Arm|"Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a diary to record symptoms of oral mucositis.~Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:~Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.~o Participants may increase the use to 6 times per day if you have symptoms of mucositis.~Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.~For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.~For patients unable to successfu"
11248204|NCT02539342|FG001|Participant Flow|Control Arm|"Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later)~Biotene: • Use 5 to 10 mL of Biotene to swish and spit~o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab."
11248205|NCT02539342|OG000|Outcome|Caphosol Arm|"Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.~Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:~Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.~Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.~Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed"
11248206|NCT02539342|OG001|Outcome|Control Arm|"Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later)~Biotene: • Use 5 to 10 mL of Biotene to swish and spit~o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab."
11248207|NCT02539342|EG000|Reported Event|Caphosol Arm|"Caphosol Arm: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day from the start of chemotherapy until 7 days after the completion of chemotherapy AND until the ANC is >500 after count recovery OR until the the symptoms or oral mucositis resolve, whichever occurs last. Patients will also complete a study diary to record symptoms of oral mucositis.~Caphosol: Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:~• Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.~o~• Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed"
10820266|NCT00055692|OG000|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11248208|NCT02539342|EG001|Reported Event|Control Arm|"Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later)~Biotene: • Use 5 to 10 mL of Biotene to swish and spit~o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab."
11248209|NCT02539368|BG000|Baseline|CT-P13|Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.
11248210|NCT02539368|BG001|Baseline|Remicade|Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.
11248211|NCT02539368|BG002|Baseline|Switched From Remicade to CT-P13|Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248212|NCT02539368|BG003|Baseline|Switched From CT-P13 to Remicade|Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248213|NCT02539368|BG004|Baseline|Multiple Switchers|Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
11248214|NCT02539368|BG005|Baseline|Total|Total of all reporting groups
11248215|NCT02539368|FG000|Participant Flow|CT-P13|Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.
11248216|NCT02539368|FG001|Participant Flow|Remicade|Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.
11248217|NCT02539368|FG002|Participant Flow|Switched From Remicade to CT-P13|Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248218|NCT02539368|FG003|Participant Flow|Switched From CT-P13 to Remicade|Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248219|NCT02539368|FG004|Participant Flow|Multiple Switchers|Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
10969679|NCT00907088|BG000|Baseline|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
11248220|NCT02539368|OG000|Outcome|CT-P13|Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.
11248221|NCT02539368|OG001|Outcome|Remicade|Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.
11248222|NCT02539368|OG002|Outcome|Switched From Remicade to CT-P13|Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248223|NCT02539368|OG003|Outcome|Switched From CT-P13 to Remicade|Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248224|NCT02539368|OG004|Outcome|Multiple Switchers|Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
11248225|NCT02539368|OG000|Outcome|Switched From Remicade to CT-P13|Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248226|NCT02539368|OG001|Outcome|Switched From CT-P13 to Remicade|Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248227|NCT02539368|OG002|Outcome|Multiple Switchers|Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
11248228|NCT02539368|EG000|Reported Event|CT-P13|Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.
11248229|NCT02539368|EG001|Reported Event|Remicade|Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.
11248230|NCT02539368|EG002|Reported Event|Switched From Remicade to CT-P13|Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248231|NCT02539368|EG003|Reported Event|Switched From CT-P13 to Remicade|Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.
11248232|NCT02539368|EG004|Reported Event|Multiple Switchers|Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
11248233|NCT02539459|BG000|Baseline|Treatment (Everolimus)|"Patients will take 10 mg (1 tablet) of everolimus each day for 4 months~Everolimus: 10 mg tablets"
11248234|NCT02539459|FG000|Participant Flow|Treatment (Everolimus)|"Patients will take 10 mg (1 tablet) of everolimus each day for 4 months~Everolimus: 10 mg tablets"
11248235|NCT02539459|OG000|Outcome|Treatment (Everolimus)|"Patients will take 10 mg (1 tablet) of everolimus each day for 4 months~Everolimus: 10 mg tablets"
11248236|NCT02539459|EG000|Reported Event|Treatment (Everolimus)|"Patients will take 10 mg (1 tablet) of everolimus each day for 4 months~Everolimus: 10 mg tablets"
11248237|NCT02539511|BG000|Baseline|Control Group: Midazolam+MET|50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.
11248238|NCT02539511|BG001|Baseline|Active Group: Ketamine+MET|50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
11248239|NCT02539511|BG002|Baseline|Total|Total of all reporting groups
11248240|NCT02539511|FG000|Participant Flow|Control Group: Midazolam+MET|50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.
11248241|NCT02539511|FG001|Participant Flow|Active Group: Ketamine+MET|50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
11248242|NCT02539511|OG000|Outcome|Control Group: Midazolam+MET|50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.
11248243|NCT02539511|OG001|Outcome|Active Group: Ketamine+MET|50-minute intravenous infusion of ketamine (0.71 mg/kg) administered during the second week of a five week regimen of motivational enhancement therapy.
11248244|NCT02539511|EG000|Reported Event|Control Group: Midazolam+MET|50-minute intravenous infusion of the active control midazolam (0.025 mg/kg), administered during the second week of a five week regimen of motivational enhancement therapy.
11248245|NCT02539511|EG001|Reported Event|Active Group: Ketamine+MET|50-minute intravenous infusion of ketamine (0.71 mg/kg) vs. 2) administered during the second week of a five week regimen of motivational enhancement therapy.
11248246|NCT02539654|BG000|Baseline|EXE844|EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
11248247|NCT02539654|FG000|Participant Flow|EXE844|EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
11248248|NCT02539654|OG000|Outcome|EXE844|EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
11248249|NCT02539654|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11248250|NCT02539654|EG001|Reported Event|EXE844|All participants who had TT inserted and received a dose of test article
11248251|NCT02539797|BG000|Baseline|All Study Participants|tDCS: comparing anodal, cathodal, and sham tDCS
11248252|NCT02539797|FG000|Participant Flow|Anodal Cathodal Sham|anodal stimulation, followed by cathodal stimulation, followed by sham stimulation
11248253|NCT02539797|FG001|Participant Flow|Cathodal Sham Anodal|cathodal stimulation, followed by sham stimulation, followed by anodal stimulation
10969680|NCT00907088|BG001|Baseline|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
10969681|NCT00907088|BG002|Baseline|Total|Total of all reporting groups
11248254|NCT02539797|FG002|Participant Flow|Sham Anodal Cathodal|sham stimulation, followed by anodal stimulation, followed by cathodal stimulation
11248255|NCT02539797|OG000|Outcome|tDCS Anodal Stimulation|"anodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
11248256|NCT02539797|OG001|Outcome|tDCS Cathodal Stimulation|"cathodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
11248257|NCT02539797|OG002|Outcome|Sham Stimulation|"Termination of electrical stimulation following 30 seconds~tDCS: comparing anodal, cathodal, and sham tDCS"
11248258|NCT02539797|EG000|Reported Event|tDCS Anodal Stimulation|"anodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
11248259|NCT02539797|EG001|Reported Event|tDCS Cathodal Stimulation|"cathodal stimulation~tDCS: comparing anodal, cathodal, and sham tDCS"
11248260|NCT02539797|EG002|Reported Event|Sham Stimulation|"Termination of electrical stimulation following 30 seconds~tDCS: comparing anodal, cathodal, and sham tDCS"
11248261|NCT02539992|BG000|Baseline|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
11248262|NCT02539992|BG001|Baseline|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
11248263|NCT02539992|BG002|Baseline|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
11248264|NCT02539992|BG003|Baseline|Total|Total of all reporting groups
11248265|NCT02539992|FG000|Participant Flow|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
11248266|NCT02539992|FG001|Participant Flow|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
11248267|NCT02539992|FG002|Participant Flow|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
10820267|NCT00055692|OG000|Outcome|Treatment (Bevacizumab): Baseline|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11248268|NCT02539992|OG000|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
11248269|NCT02539992|OG001|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
11248270|NCT02539992|OG002|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
11248271|NCT02539992|OG000|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
11248272|NCT02539992|OG001|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
11248273|NCT02539992|EG000|Reported Event|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
11248274|NCT02539992|EG001|Reported Event|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
11248275|NCT02539992|EG002|Reported Event|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
11248276|NCT02540083|BG000|Baseline|Experimental: DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging"
11248277|NCT02540083|FG000|Participant Flow|Experimental: DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging"
11248278|NCT02540083|OG000|Outcome|Experimental: DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging"
11248279|NCT02540083|EG000|Reported Event|Experimental: DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging"
11248280|NCT02540161|BG000|Baseline|Non-bevacizumab Failures - 18 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248281|NCT02540161|BG001|Baseline|Bevacizumab Failures - 18 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248282|NCT02540161|BG002|Baseline|Non-bevacizumab Failures - 24 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248283|NCT02540161|BG003|Baseline|Bevacizumab Failures - 24 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
10969682|NCT00907088|FG000|Participant Flow|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
11248284|NCT02540161|BG004|Baseline|Total|Total of all reporting groups
11248285|NCT02540161|FG000|Participant Flow|Non-bevacizumab Failures - 18 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248286|NCT02540161|FG001|Participant Flow|Bevacizumab Failures - 18 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248287|NCT02540161|FG002|Participant Flow|Non-bevacizumab Failures - 24 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248288|NCT02540161|FG003|Participant Flow|Bevacizumab Failures - 24 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248289|NCT02540161|OG000|Outcome|Non-bevacizumab Failures - 18 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
10820268|NCT00055692|OG001|Outcome|Treatment (Bevacizumab): 8 Weeks|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11213478|NCT02286895|OG001|Outcome|Group B (With Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).~pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213479|NCT02286895|EG000|Reported Event|Group A (Without Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213480|NCT02286895|EG001|Reported Event|Group B (With Rotavirus Vaccine)|"Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).~pentavalent rotavirus vaccine (PRV): At enrollment, infants in this group receive one dose of 2.0ml orally~measles vaccine (MV): At enrollment, all infants will receive one dose of 0.5ml subcutaneously~yellow fever vaccine (YFV): At enrollment, all infants will receive one dose of 0.5ml intramuscularly~meningitis conjugate vaccine (PsA-TT-5μg): At enrollment, all infants will receive one dose of 0.5ml intramuscularly"
11213481|NCT02286921|BG000|Baseline|Arm A: Testosterone Cypionate or Testosterone Enanthate|"Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.~Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative."
11213482|NCT02286921|BG001|Baseline|Arm B: Enzalutamide|"Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.~Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide."
11213483|NCT02286921|BG002|Baseline|Total|Total of all reporting groups
11213484|NCT02286921|FG000|Participant Flow|Arm A: Testosterone Cypionate or Testosterone Enanthate|"Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.~Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative."
11213485|NCT02286921|FG001|Participant Flow|Arm B: Enzalutamide|"Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.~Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide."
11213486|NCT02286921|OG000|Outcome|Arm A: Testosterone Cypionate or Testosterone Enanthate|"Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.~Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative."
11213487|NCT02286921|OG001|Outcome|Arm B: Enzalutamide|"Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.~Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide."
11248290|NCT02540161|OG001|Outcome|Bevacizumab Failures - 18 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248291|NCT02540161|OG002|Outcome|Non-bevacizumab Failures - 24 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248292|NCT02540161|OG003|Outcome|Bevacizumab Failures - 24 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248293|NCT02540161|EG000|Reported Event|Non-bevacizumab Failures - 18 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks."
11248294|NCT02540161|EG001|Reported Event|Bevacizumab Failures - 18 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks. ."
11248295|NCT02540161|EG002|Reported Event|Non-bevacizumab Failures - 24 mg/kg|"Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.~Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248296|NCT02540161|EG003|Reported Event|Bevacizumab Failures - 24 mg/kg|"Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.~Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks."
11248297|NCT02540213|BG000|Baseline|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
11248298|NCT02540213|FG000|Participant Flow|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
11248299|NCT02540213|OG000|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
11248300|NCT02540213|EG000|Reported Event|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
11248301|NCT02540226|BG000|Baseline|Intravenous Tranexamic Acid|"Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.~Intravenous tranexamic acid~Topical saline"
11248302|NCT02540226|BG001|Baseline|Topical Tranexamic Acid|"Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.~Topical tranexamic acid~Intravenous saline"
11248303|NCT02540226|BG002|Baseline|Total|Total of all reporting groups
11248304|NCT02540226|FG000|Participant Flow|Intravenous Tranexamic Acid|"Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.~Intravenous tranexamic acid~Topical saline"
11248305|NCT02540226|FG001|Participant Flow|Topical Tranexamic Acid|"Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.~Topical tranexamic acid~Intravenous saline"
10820269|NCT00055692|EG000|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
11213488|NCT02286921|EG000|Reported Event|Arm A: Testosterone Cypionate or Testosterone Enanthate|"Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.~Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative."
11213489|NCT02286921|EG001|Reported Event|Arm B: Enzalutamide|"Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.~Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide."
11213490|NCT02286947|BG000|Baseline|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg IV infusions, weekly, for 96 weeks.
11213491|NCT02286947|FG000|Participant Flow|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg intravenous (IV) infusions, once weekly, for 96 weeks.
11213492|NCT02286947|OG000|Outcome|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg IV infusions, weekly, for 96 weeks.
11213493|NCT02286947|OG000|Outcome|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg intravenous (IV) infusions, weekly, for 96 weeks.
11213494|NCT02286947|OG000|Outcome|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg intravenous (IV) infusions, once weekly, for 96 weeks.
11213495|NCT02286947|EG000|Reported Event|Eteplirsen 30 mg/kg|Participants received eteplirsen 30 mg/kg IV infusions, weekly, for 96 weeks.
11213496|NCT02286960|BG000|Baseline|Steroid|"Prednizone pills. 4 day course 2 x 20mg per day.~Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy."
11213497|NCT02286960|BG001|Baseline|Placebo|"Lactose Pills. 4 day course 2 x 20mg per day.~Lactose Pills: 4 day course 2 x 20mg per da"
11213498|NCT02286960|BG002|Baseline|Total|Total of all reporting groups
11213499|NCT02286960|FG000|Participant Flow|Steroid|"Prednizone pills. 4 day course 2 x 20mg per day.~Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy."
11213500|NCT02286960|FG001|Participant Flow|Placebo|"Lactose Pills. 4 day course 2 x 20mg per day.~Lactose Pills: 4 day course 2 x 20mg per da"
11213501|NCT02286960|OG000|Outcome|Steroid|"Prednizone pills. 4 day course 2 x 20mg per day.~Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy."
11213502|NCT02286960|OG001|Outcome|Placebo|"Lactose Pills. 4 day course 2 x 20mg per day.~Lactose Pills: 4 day course 2 x 20mg per da"
11213503|NCT02286960|EG000|Reported Event|Steroid|"Prednizone pills. 4 day course 2 x 20mg per day.~Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy."
11213504|NCT02286960|EG001|Reported Event|Placebo|"Lactose Pills. 4 day course 2 x 20mg per day.~Lactose Pills: 4 day course 2 x 20mg per da"
11213505|NCT02287038|BG000|Baseline|Group1|Group 1: Atomoxetine during the first phase ( 4 Weeks), the Wash-out (1week), followed by a second phase (4 Weeks) of placebo.
11213506|NCT02287038|BG001|Baseline|Group 2|Group 2: Placebo during the first phase ( 4 Weeks), the Wash-out (1week), followed by a second phase (4 Weeks) of Atomoxetine.
11213507|NCT02287038|BG002|Baseline|Total|Total of all reporting groups
11213508|NCT02287038|FG000|Participant Flow|Group 1. Atomoxitine First, Then Placebo|Subjects in Group 1: First Intervention (4 weeks with Atomoxetine), Wash-out (1 week), and Second Intervention (4 weeks with placebo)
11213509|NCT02287038|FG001|Participant Flow|Group 2. Placebo First, Then Atomoxitine|Subjects in Group 1: First Intervention (4 weeks with placebo), Wash-out (1 week), and Second Intervention (4 weeks with Atomoxetine)
11213510|NCT02287038|OG000|Outcome|Arm1: Atomoxetine|This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 1 received Atomoxetine during the first phase, and Group2 receive Atomoxetine in the second phase.
11213511|NCT02287038|OG001|Outcome|Arm 2: Placebo|This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 2 received the placebo during the first phase, and Group 1 receive placebo during the second phase.
11213512|NCT02287038|OG000|Outcome|Arm 1: Atomoxetine|This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 1 will receive Atomoxetine during the first phase and Group 2 would receive Atomoxetine in the second phase.
11213513|NCT02287038|OG001|Outcome|Arm 2: Placebo|This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 2 will receive placebo during the first phase and Group 1 would receive placebo in the second phase.
11213514|NCT02287038|EG000|Reported Event|Arm1, Atomoxetine|Group 1 received Atomoxetine during the first phase of the study, and Group 2 received Atomoxetine during the second phase.
11213515|NCT02287038|EG001|Reported Event|Arm2, Placebo|Group 2 received the placebo during the first phase of the study, and Group 1 received the placebo during the second phase.
10820270|NCT00056160|BG000|Baseline|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
11213516|NCT02287350|BG000|Baseline|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
11213517|NCT02287350|FG000|Participant Flow|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
11213518|NCT02287350|OG000|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
11213519|NCT02287350|EG000|Reported Event|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.~diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
11213520|NCT02287376|BG000|Baseline|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
11213521|NCT02287376|FG000|Participant Flow|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
11213522|NCT02287376|OG000|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
11213523|NCT02287376|EG000|Reported Event|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
11213524|NCT02287402|BG000|Baseline|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
11213525|NCT02287402|FG000|Participant Flow|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
11213526|NCT02287402|OG000|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
11213527|NCT02287402|EG000|Reported Event|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
11213528|NCT02287415|BG000|Baseline|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
11213529|NCT02287415|FG000|Participant Flow|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
11213530|NCT02287415|OG000|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
11213531|NCT02287415|EG000|Reported Event|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
11213532|NCT02287467|BG000|Baseline|Arm A: hIVIG|"Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)"
11213533|NCT02287467|BG001|Baseline|Arm B: Placebo|"Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11213534|NCT02287467|BG002|Baseline|Total|Total of all reporting groups
11213535|NCT02287467|FG000|Participant Flow|Arm A: hIVIG|"Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive standard of care (SOC )treatment for the flu.~Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)"
11213536|NCT02287467|FG001|Participant Flow|Arm B: Placebo|"Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11213537|NCT02287467|OG000|Outcome|Arm A: hIVIG|"Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)"
11213538|NCT02287467|OG001|Outcome|Arm B: Placebo|"Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11213539|NCT02287467|OG001|Outcome|Arm B: Placebo|"Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11213540|NCT02287467|OG000|Outcome|Arm A: hIVIG|"Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)"
11213541|NCT02287467|OG001|Outcome|Arm B: Placebo|"Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11248306|NCT02540226|OG000|Outcome|Intravenous Tranexamic Acid|"Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.~Intravenous tranexamic acid~Topical saline"
11248307|NCT02540226|OG001|Outcome|Topical Tranexamic Acid|"Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.~Topical tranexamic acid~Intravenous saline"
11248308|NCT02540226|EG000|Reported Event|Intravenous Tranexamic Acid|"Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.~Intravenous tranexamic acid~Topical saline"
11248309|NCT02540226|EG001|Reported Event|Topical Tranexamic Acid|"Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.~Topical tranexamic acid~Intravenous saline"
11248310|NCT02540265|BG000|Baseline|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
11248311|NCT02540265|BG001|Baseline|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
11248312|NCT02540265|BG002|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11248313|NCT02540265|BG003|Baseline|Total|Total of all reporting groups
11248314|NCT02540265|FG000|Participant Flow|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
10820271|NCT00056160|BG001|Baseline|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
11248315|NCT02540265|FG001|Participant Flow|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
10820272|NCT00056160|BG002|Baseline|Total|Total of all reporting groups
11248316|NCT02540265|FG002|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11248317|NCT02540265|OG000|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
11248318|NCT02540265|OG001|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
11248319|NCT02540265|OG002|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11248320|NCT02540265|EG000|Reported Event|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
11248321|NCT02540265|EG001|Reported Event|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
11248322|NCT02540265|EG002|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11248323|NCT02540291|BG000|Baseline|E7046 125 mg|Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248324|NCT02540291|BG001|Baseline|E7046 250 mg|Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248325|NCT02540291|BG002|Baseline|E7046 500 mg|Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248326|NCT02540291|BG003|Baseline|E7046 750 mg|Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248327|NCT02540291|BG004|Baseline|Total|Total of all reporting groups
10820273|NCT00056160|FG000|Participant Flow|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
11248328|NCT02540291|FG000|Participant Flow|E7046 125 mg|Participants received E7046 125 milligram (mg) capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248329|NCT02540291|FG001|Participant Flow|E7046 250 mg|Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248330|NCT02540291|FG002|Participant Flow|E7046 500 mg|Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248331|NCT02540291|FG003|Participant Flow|E7046 750 mg|Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248332|NCT02540291|OG000|Outcome|E7046 125 mg|Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248333|NCT02540291|OG001|Outcome|E7046 250 mg|Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248334|NCT02540291|OG002|Outcome|E7046 500 mg|Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248335|NCT02540291|OG003|Outcome|E7046 750 mg|Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248336|NCT02540291|OG000|Outcome|E7046: All Participants|Participants received E7046 125, 250, 500 or 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248337|NCT02540291|OG000|Outcome|E7046: All Participants|Participants received E7046 125 mg, 250 mg, 500 mg or 700 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248338|NCT02540291|EG000|Reported Event|E7046 125 mg|Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248339|NCT02540291|EG001|Reported Event|E7046 250 mg|Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248340|NCT02540291|EG002|Reported Event|E7046 500 mg|Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248341|NCT02540291|EG003|Reported Event|E7046 750 mg|Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
11248342|NCT02540356|BG000|Baseline|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
11248343|NCT02540356|BG001|Baseline|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
11248344|NCT02540356|BG002|Baseline|Total|Total of all reporting groups
11248345|NCT02540356|FG000|Participant Flow|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
11248346|NCT02540356|FG001|Participant Flow|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
11248347|NCT02540356|OG000|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
11248348|NCT02540356|OG001|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
11248349|NCT02540356|EG000|Reported Event|Overall Trial|Treatment with Imalumab (BAX69) over a 4-week treatment period administered weekly at one of the following dose regimens: BAX69 5mg/kg IP (intraperitoneal) (Cohort S1), 10mg/kg IP (Cohort S2), 15mg/kg IP (Cohort S3), 5mg/kg IV (intravenous) + 5mg/kg IP (intraperitoneal) (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
11248350|NCT02540447|BG000|Baseline|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
11248351|NCT02540447|BG001|Baseline|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
11248352|NCT02540447|BG002|Baseline|Total|Total of all reporting groups
11248353|NCT02540447|FG000|Participant Flow|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
11248354|NCT02540447|FG001|Participant Flow|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
11286370|NCT02887183|BG000|Baseline|LCZ696(Sacubitril/Valsartan)|"Subjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3).~Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily."
11248355|NCT02540447|OG000|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
11248356|NCT02540447|OG001|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
11248357|NCT02540447|EG000|Reported Event|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
11248358|NCT02540447|EG001|Reported Event|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
11248359|NCT02540538|BG000|Baseline|HB Vaccine Naive - HBVaxPro|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBVaxPro-10ug at day 0, 30, and 180.~HBVaxPro: 3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days."
11248360|NCT02540538|BG001|Baseline|HB Vaccine Naive - HBAI20|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248361|NCT02540538|BG002|Baseline|Non-responders - HBAI20|"Subjects have been vaccinated 6 times with a Hepatitis B vaccine without developing a protective immune response, measured as anti Hepatitis B surface antigen antibodies, superior to 10mIU/ml.~Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248362|NCT02540538|BG003|Baseline|Total|Total of all reporting groups
11248363|NCT02540538|FG000|Participant Flow|HB Vaccine Naive - HBVaxPro|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBVaxPro-10ug at day 0, 30, and 180.~HBVaxPro: 3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days."
11248364|NCT02540538|FG001|Participant Flow|HB Vaccine Naive - HBAI20|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248365|NCT02540538|FG002|Participant Flow|Non-responders - HBAI20|"Subjects have been vaccinated 6 times with a Hepatitis B vaccine without developing a protective immune response, measured as anti Hepatitis B surface antigen antibodies, superior to 10mIU/ml.~Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248366|NCT02540538|OG000|Outcome|HB Vaccine Naive - HBVaxPro|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBVaxPro-10ug at day 0, 30, and 180.~HBVaxPro: 3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days."
11248367|NCT02540538|OG001|Outcome|HB Vaccine Naive - HBAI20|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248368|NCT02540538|OG002|Outcome|Non-responders - HBAI20|"Subjects have been vaccinated 6 times with a Hepatitis B vaccine without developing a protective immune response, measured as anti Hepatitis B surface antigen antibodies, superior to 10mIU/ml.~Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248369|NCT02540538|EG000|Reported Event|HB Vaccine Naive - HBVaxPro|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBVaxPro-10ug at day 0, 30, and 180.~HBVaxPro: 3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days."
10969683|NCT00907088|FG001|Participant Flow|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
11248370|NCT02540538|EG001|Reported Event|HB Vaccine Naive - HBAI20|"Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
10969684|NCT00907088|OG000|Outcome|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
11248371|NCT02540538|EG002|Reported Event|Non-responders - HBAI20|"Subjects have been vaccinated 6 times with a Hepatitis B vaccine without developing a protective immune response, measured as anti Hepatitis B surface antigen antibodies, superior to 10mIU/ml.~Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.~HBAI20: 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days."
11248372|NCT02540629|BG000|Baseline|Conventional EMS CPR (2013-2014, 2 Years)|Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.
11248373|NCT02540629|BG001|Baseline|Bundled EMS CPR (2015-2016, 2 Years)|"The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.~Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR."
11248374|NCT02540629|BG002|Baseline|Total|Total of all reporting groups
11248375|NCT02540629|FG000|Participant Flow|Conventional EMS CPR (2013-2014, 2 Years)|Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.
11248376|NCT02540629|FG001|Participant Flow|Bundled EMS CPR (2015-2016, 2 Years)|"The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.~Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR."
11248377|NCT02540629|OG000|Outcome|Conventional EMS CPR|Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.
11248378|NCT02540629|OG001|Outcome|Bundled EMS CPR|"The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.~Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR."
11248379|NCT02540629|OG001|Outcome|Bundled EMS CPR|"The main study phase will begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.~Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR."
11248380|NCT02540629|EG000|Reported Event|Conventional EMS CPR|Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.
11248381|NCT02540629|EG001|Reported Event|Bundled EMS CPR|"The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.~Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR."
11248382|NCT02540668|BG000|Baseline|Overall|Overall study population.
11248383|NCT02540668|FG000|Participant Flow|Warfarin|Single oral dose of 15 milligram (mg) warfarin on Day 1.
11248384|NCT02540668|FG001|Participant Flow|LY3314814 + Warfarin|LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
11248385|NCT02540668|OG000|Outcome|Warfarin|Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
11248386|NCT02540668|OG001|Outcome|LY3314814 + Warfarin|LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22. LY3314814: Administered orally Warfarin: Administered orally
11248387|NCT02540668|EG000|Reported Event|Warfarin|Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
11248388|NCT02540668|EG001|Reported Event|LY3314814|LY3314814 administered orally once daily on Days 8 to 27 LY3314814: Administered orally
11248389|NCT02540668|EG002|Reported Event|LY3314814 + Warfarin|Single oral dose of 15 mg warfarin co-administered on Day 22. LY3314814: Administered orally Warfarin: Administered orally
11248390|NCT02540772|BG000|Baseline|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
11248391|NCT02540772|BG001|Baseline|No Treatment|Patients in the control group only performed the baselines.
11248392|NCT02540772|BG002|Baseline|Total|Total of all reporting groups
11248393|NCT02540772|FG000|Participant Flow|Neuropsychological Treatment|"The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.~Neuropsychological treatment: Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors. This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment."
11248394|NCT02540772|FG001|Participant Flow|No Treatment|Patients in the control group only performed the baselines.
11248395|NCT02540772|OG000|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
11248396|NCT02540772|OG001|Outcome|No Treatment|Patients in the control group only performed the baselines.
11248397|NCT02540772|EG000|Reported Event|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
11248398|NCT02540772|EG001|Reported Event|No Treatment|Patients in the control group only performed the baselines.
11248399|NCT02540850|BG000|Baseline|CRC Group|stage 0-IV CRC subjects
11248400|NCT02540850|BG001|Baseline|Precancerous Disease Group|subjects with adenoma or polyps
11248401|NCT02540850|BG002|Baseline|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
11248402|NCT02540850|BG003|Baseline|Total|Total of all reporting groups
11248403|NCT02540850|FG000|Participant Flow|CRC Group|stage 0-IV CRC subjects
11248404|NCT02540850|FG001|Participant Flow|Precancerous Disease Group|subjects with adenoma or polyps
11248405|NCT02540850|FG002|Participant Flow|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
11248406|NCT02540850|OG000|Outcome|CRC Group|stage 0-IV CRC subjects
11248407|NCT02540850|OG001|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
11248408|NCT02540850|OG002|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
11248409|NCT02540850|EG000|Reported Event|CRC Group|stage 0-IV CRC subjects
11248410|NCT02540850|EG001|Reported Event|Precancerous Disease Group|subjects with adenoma or polyps
11248411|NCT02540850|EG002|Reported Event|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
11248412|NCT02540954|BG000|Baseline|Aflibercept Extended Dosing|Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
11248413|NCT02540954|BG001|Baseline|Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)|Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
11248414|NCT02540954|BG002|Baseline|Total|Total of all reporting groups
11248415|NCT02540954|FG000|Participant Flow|Aflibercept Extended Dosing|Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
11248416|NCT02540954|FG001|Participant Flow|Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)|Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
10820274|NCT00056160|FG001|Participant Flow|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
11248417|NCT02540954|OG000|Outcome|Aflibercept Extended Dosing|Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
11248418|NCT02540954|OG001|Outcome|Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)|Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
11248419|NCT02540954|EG000|Reported Event|Aflibercept Extended Dosing|Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
11248420|NCT02540954|EG001|Reported Event|Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)|Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
11248421|NCT02540993|BG000|Baseline|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11248422|NCT02540993|BG001|Baseline|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11248423|NCT02540993|BG002|Baseline|Total|Total of all reporting groups
11248424|NCT02540993|FG000|Participant Flow|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11248425|NCT02540993|FG001|Participant Flow|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11248426|NCT02540993|OG000|Outcome|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11248427|NCT02540993|OG001|Outcome|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11248428|NCT02540993|EG000|Reported Event|Finerenone|Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
11248429|NCT02540993|EG001|Reported Event|Placebo|Participants received matching placebo once daily in addition to standard of care therapy
11248430|NCT02541409|BG000|Baseline|SOF+PEG+RBV|"Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248431|NCT02541409|BG001|Baseline|SOF+RBV|"Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248432|NCT02541409|BG002|Baseline|Total|Total of all reporting groups
11248433|NCT02541409|FG000|Participant Flow|SOF+PEG+RBV|"Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248434|NCT02541409|FG001|Participant Flow|SOF+RBV|"Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248435|NCT02541409|OG000|Outcome|SOF+PEG+RBV|"Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248436|NCT02541409|OG001|Outcome|SOF+RBV|"Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248437|NCT02541409|EG000|Reported Event|SOF+PEG+RBV|"Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248438|NCT02541409|EG001|Reported Event|SOF+RBV|"Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C"
11248439|NCT02541422|BG000|Baseline|All Study Participants|All study participants received the 2 interventions - NAC and placebo. The participants completed one intervention on one day and returned to complete the other intervention on a subsequent day.
10820275|NCT00056160|OG000|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
11248440|NCT02541422|FG000|Participant Flow|NAC First, Then Placebo|Patients receiving NAC after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received placebo then again completed the survey in the morning
11248441|NCT02541422|FG001|Participant Flow|Placebo First Then NAC Group|Patients receiving placebo after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received NAC then again completed the survey in the morning
11248442|NCT02541422|OG000|Outcome|NAC Group|"Patients receiving NAC after drinking to breathalyzer value 0.1~N Acetyl Cysteine"
11248443|NCT02541422|OG001|Outcome|Placebo Group|"Patients receiving placebo after drinking to breathalyzer value 0.1~placebo"
11248444|NCT02541422|EG000|Reported Event|NAC Group|"Patients receiving NAC after drinking to breathalyzer value 0.1~N Acetyl Cysteine"
11248445|NCT02541422|EG001|Reported Event|Placebo Group|"Patients receiving placebo after drinking to breathalyzer value 0.1~placebo"
11248446|NCT02541565|BG000|Baseline|Treatment (Pembrolizumab, Combination Chemotherapy)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and prednisone PO on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11248447|NCT02541565|FG000|Participant Flow|Treatment (Pembrolizumab, Combination Chemotherapy)|"Patients will receive pembrolizumab IV over 30 minutes on day 1 and prednisone PO on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11248448|NCT02541565|OG000|Outcome|Treatment (Pembrolizumab, Combination Chemotherapy)|"Patients will receive pembrolizumab IV over 30 minutes on day 1 and prednisone PO on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11248449|NCT02541565|EG000|Reported Event|Treatment (Pembrolizumab, Combination Chemotherapy)|"Patients will receive pembrolizumab IV over 30 minutes on day 1 and prednisone PO on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11248450|NCT02541604|BG000|Baseline|COHORT 1|EWING SARCOMA
11248451|NCT02541604|BG001|Baseline|COHORT 2|HODGKIN LYMPHOMA
10820276|NCT00056160|OG001|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
11248452|NCT02541604|BG002|Baseline|COHORT 3|NEUROBLASTOMA
11248453|NCT02541604|BG003|Baseline|COHORT 4|NON HODGKIN LYMPHOMA
11248454|NCT02541604|BG004|Baseline|COHORT 5|NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
11248455|NCT02541604|BG005|Baseline|COHORT 6|OSTEOSARCOMA
11248456|NCT02541604|BG006|Baseline|COHORT 7|RHABDOMYOSARCOMA
11248457|NCT02541604|BG007|Baseline|COHORT 8|WILMS TUMOR
11248458|NCT02541604|BG008|Baseline|COHORT 9|OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
11248459|NCT02541604|BG009|Baseline|COHORT 10|OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
11248460|NCT02541604|BG010|Baseline|COHORT 11|RHABDOID TUMOR
10969685|NCT00907088|OG001|Outcome|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
11248461|NCT02541604|BG011|Baseline|COHORT 12|ATYPICAL TERATOID RHABDOID TUMOR
11248462|NCT02541604|BG012|Baseline|Total|Total of all reporting groups
11248463|NCT02541604|FG000|Participant Flow|COHORT 1|EWING SARCOMA
11248464|NCT02541604|FG001|Participant Flow|COHORT 2|HODGKIN LYMPHOMA
11248465|NCT02541604|FG002|Participant Flow|COHORT 3|NEUROBLASTOMA
11248466|NCT02541604|FG003|Participant Flow|COHORT 4|NON HODGKIN LYMPHOMA
11248467|NCT02541604|FG004|Participant Flow|COHORT 5|NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
11248468|NCT02541604|FG005|Participant Flow|COHORT 6|OSTEOSARCOMA
11248469|NCT02541604|FG006|Participant Flow|COHORT 7|RHABDOMYOSARCOMA
11248470|NCT02541604|FG007|Participant Flow|COHORT 8|WILMS TUMOR
11248471|NCT02541604|FG008|Participant Flow|COHORT 9|OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
11248472|NCT02541604|FG009|Participant Flow|COHORT 10|OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
11248473|NCT02541604|FG010|Participant Flow|COHORT 11|RHABDOID TUMOR
11248474|NCT02541604|FG011|Participant Flow|COHORT 12|ATYPICAL TERATOID RHABDOID TUMOR
11248475|NCT02541604|OG000|Outcome|Cohort 1|Participants with ewing sarcoma
11248476|NCT02541604|OG001|Outcome|Cohort 5|Participants with non-rhabdomyosarcoma soft tissue sarcoma
11248477|NCT02541604|OG002|Outcome|Cohort 6|Participants with osteosarcoma.
11248478|NCT02541604|OG003|Outcome|Cohort 7|Participants with rhabdomyosarcoma
11248479|NCT02541604|OG004|Outcome|Cohort 8|Participants with wilms tumor
11248480|NCT02541604|OG005|Outcome|Cohort 9|Participants with other tumor types with documented PD-L1 expression.
11248481|NCT02541604|OG006|Outcome|Cohort 10|Participants with other tumor types without documented PD-L1 expression.
11248482|NCT02541604|OG007|Outcome|Cohort 11|Participants with rhabdoid tumor.
11248483|NCT02541604|OG000|Outcome|Cohort 3|Participants with neuroblastoma.
11248484|NCT02541604|OG000|Outcome|Cohort 2|Participants with Hodgkin's lymphoma
11248485|NCT02541604|OG001|Outcome|Cohort 4|Participants with non-Hodgkin's lymphoma
11248486|NCT02541604|OG000|Outcome|Cohort 12|Participants with atypical teratoid rhabdoid tumor.
11248487|NCT02541604|OG000|Outcome|Cohort 6|Participants with osteosarcoma.
11248488|NCT02541604|OG000|Outcome|Cohort 1|Participants with ewing sarcoma.
11248489|NCT02541604|OG003|Outcome|Cohort 7|Participants with rhabdomyosarcoma.
11248490|NCT02541604|OG004|Outcome|Cohort 8|Participants with wilms tumor.
11248491|NCT02541604|OG006|Outcome|Cohort 10|Participant with other tumor types without documented PD-L1 expression.
11248492|NCT02541604|OG000|Outcome|Cohort 2|Participants with hodgkin's lymphoma.
11248493|NCT02541604|OG001|Outcome|Cohort 4|Participants with non-hodgkin's lymphoma.
11248494|NCT02541604|OG000|Outcome|Atezolizumab|Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
11248495|NCT02541604|OG000|Outcome|<2 Age (Years)|Participants <2 Age (Years)
11248496|NCT02541604|OG001|Outcome|2 to <12 Age (Years)|Participants 2 to <12 Age (Years)
11248497|NCT02541604|OG002|Outcome|12 to <18 Age (Years)|Participants 12 to <18 Age (Years)
11248498|NCT02541604|OG003|Outcome|>=18 Age (Years)|Participants >=18 Age (Years)
11248499|NCT02541604|OG001|Outcome|Cohort 5|Participants with non-rhabdomyosarcoma soft tissue sarcoma.
11248500|NCT02541604|OG000|Outcome|Cohort 2|Participants with hodgkin lymphoma.
11248501|NCT02541604|OG001|Outcome|Cohort 4|Participants with non-hodgkin's lymphoma
11248502|NCT02541604|OG001|Outcome|Cohort 5|Participants with non-rhabdomyosarcoma.
11248503|NCT02541604|OG008|Outcome|Cohort 12|Participants with atypical teratoid rhabdoid tumor.
11248504|NCT02541604|OG001|Outcome|Cohort 4|Participants with non-hodgkin lymphoma.
11248505|NCT02541604|OG000|Outcome|Cohort 3|Participants with neuroblastoma
11248506|NCT02541604|OG000|Outcome|Cohort 2|Participants with hodgkin lymphoma
11248507|NCT02541604|OG000|Outcome|Cohort 2|Participants with Hodgkin lymphoma.
11248508|NCT02541604|OG000|Outcome|<18 Age (Years)|Participants <18 Age (Years)
11248509|NCT02541604|OG000|Outcome|>=18 Age (Years)|Participants >=18 Age (Years)
11248510|NCT02541604|EG000|Reported Event|COHORT 1|EWING SARCOMA
11248511|NCT02541604|EG001|Reported Event|COHORT 2|HODGKIN LYMPHOMA
11248512|NCT02541604|EG002|Reported Event|COHORT 3|NEUROBLASTOMA
11248513|NCT02541604|EG003|Reported Event|COHORT 4|NON HODGKIN LYMPHOMA
11248514|NCT02541604|EG004|Reported Event|COHORT 5|NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
11248515|NCT02541604|EG005|Reported Event|COHORT 6|OSTEOSARCOMA
11248516|NCT02541604|EG006|Reported Event|COHORT 7|RHABDOMYOSARCOMA
11248517|NCT02541604|EG007|Reported Event|COHORT 8|WILMS TUMOR
11248518|NCT02541604|EG008|Reported Event|COHORT 9|OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
11248519|NCT02541604|EG009|Reported Event|COHORT 10|OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
11248520|NCT02541604|EG010|Reported Event|COHORT 11|RHABDOID TUMOR
11248521|NCT02541604|EG011|Reported Event|COHORT 12|ATYPICAL TERATOID RHABDOID TUMOR
11248522|NCT02541669|BG000|Baseline|Open Label: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248523|NCT02541669|BG001|Baseline|Open Label: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248524|NCT02541669|BG002|Baseline|Double-blind: Placebo|TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248525|NCT02541669|BG003|Baseline|Double-blind: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248526|NCT02541669|BG004|Baseline|Double-blind: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248527|NCT02541669|BG005|Baseline|Total|Total of all reporting groups
11248528|NCT02541669|FG000|Participant Flow|Open Label: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248529|NCT02541669|FG001|Participant Flow|Open Label: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248530|NCT02541669|FG002|Participant Flow|Double-blind: Placebo|TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248531|NCT02541669|FG003|Participant Flow|Double-blind: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248532|NCT02541669|FG004|Participant Flow|Double-blind: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248533|NCT02541669|OG000|Outcome|Open Label: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
10820277|NCT00056160|EG000|Reported Event|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
11248534|NCT02541669|OG001|Outcome|Open Label: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248535|NCT02541669|OG002|Outcome|Double-blind: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248536|NCT02541669|OG003|Outcome|Double-blind: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248537|NCT02541669|EG000|Reported Event|Open Label: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
10820278|NCT00056160|EG001|Reported Event|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
11248538|NCT02541669|EG001|Reported Event|Open Label: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
11248539|NCT02541669|EG002|Reported Event|Double-blind: Placebo|TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248540|NCT02541669|EG003|Reported Event|Double-blind: TAK-491 40 mg|TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248541|NCT02541669|EG004|Reported Event|Double-blind: TAK-491 80 mg|TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
11248542|NCT02541812|BG000|Baseline|Patients|"Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248543|NCT02541812|BG001|Baseline|Healthy Control Subjects|"One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248544|NCT02541812|BG002|Baseline|Total|Total of all reporting groups
11248545|NCT02541812|FG000|Participant Flow|Patients|"Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248546|NCT02541812|FG001|Participant Flow|Healthy Control Subjects|"One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248547|NCT02541812|OG000|Outcome|Patients|"Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248548|NCT02541812|OG000|Outcome|Patients|"One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248549|NCT02541812|OG001|Outcome|Healthy Control Subjects|"One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248550|NCT02541812|EG000|Reported Event|Patients|"Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248551|NCT02541812|EG001|Reported Event|Healthy Control Subjects|"One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals~Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation"
11248552|NCT02541864|BG000|Baseline|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
11248553|NCT02541864|BG001|Baseline|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
11248554|NCT02541864|BG002|Baseline|Total|Total of all reporting groups
11248555|NCT02541864|FG000|Participant Flow|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
11248556|NCT02541864|FG001|Participant Flow|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
11248557|NCT02541864|OG000|Outcome|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
11248558|NCT02541864|OG001|Outcome|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
11248559|NCT02541864|EG000|Reported Event|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
11248560|NCT02541864|EG001|Reported Event|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days~Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
11248561|NCT02541903|BG000|Baseline|Gilotrif|"Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).~Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur."
11248562|NCT02541903|FG000|Participant Flow|Gilotrif|"Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).~Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur."
10820279|NCT00056316|BG000|Baseline|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
10820280|NCT00056316|BG001|Baseline|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
11248563|NCT02541903|OG000|Outcome|Gilotrif|"Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).~Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur."
11248564|NCT02541903|EG000|Reported Event|Gilotrif|"Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).~Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur."
11248565|NCT02541942|BG000|Baseline|Subjects for Analysis|Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.
11248566|NCT02541942|FG000|Participant Flow|Subjects for Analysis|Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.
11248567|NCT02541942|OG000|Outcome|Subjects for Analysis|Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.
11248568|NCT02541942|EG000|Reported Event|Subjects for Analysis|Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.
11248569|NCT02542046|BG000|Baseline|Barium|"Patients who received barium sulfate oral contrast for abdominopelvic CT~Barium: Administration of barium oral contrast agent prior to CT scan"
11248570|NCT02542046|BG001|Baseline|Diatrizoate|"Patients who received diatrizoate oral contrast for abdominopelvic CT~Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan"
11248571|NCT02542046|BG002|Baseline|Iohexol|"Patients who received iohexol oral contrast for abdominopelvic CT~Iohexol: Administration of iohexol oral contrast agent prior to CT scan"
11248572|NCT02542046|BG003|Baseline|Total|Total of all reporting groups
11248573|NCT02542046|FG000|Participant Flow|Barium|"Patients who received barium sulfate oral contrast for abdominopelvic CT~Barium: Administration of barium oral contrast agent prior to CT scan"
11248574|NCT02542046|FG001|Participant Flow|Diatrizoate|"Patients who received diatrizoate oral contrast for abdominopelvic CT~Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan"
11248575|NCT02542046|FG002|Participant Flow|Iohexol|"Patients who received iohexol oral contrast for abdominopelvic CT~Iohexol: Administration of iohexol oral contrast agent prior to CT scan"
11248576|NCT02542046|OG000|Outcome|Barium|"Patients who received barium sulfate oral contrast for abdominopelvic CT~Barium: Administration of barium oral contrast agent prior to CT scan"
11248577|NCT02542046|OG001|Outcome|Diatrizoate|"Patients who received diatrizoate oral contrast for abdominopelvic CT~Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan"
11248578|NCT02542046|OG002|Outcome|Iohexol|"Patients who received iohexol oral contrast for abdominopelvic CT~Iohexol: Administration of iohexol oral contrast agent prior to CT scan"
11248579|NCT02542046|EG000|Reported Event|Barium|"Patients who received barium sulfate oral contrast for abdominopelvic CT~Barium: Administration of barium oral contrast agent prior to CT scan"
11248580|NCT02542046|EG001|Reported Event|Diatrizoate|"Patients who received diatrizoate oral contrast for abdominopelvic CT~Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan"
11248581|NCT02542046|EG002|Reported Event|Iohexol|"Patients who received iohexol oral contrast for abdominopelvic CT~Iohexol: Administration of iohexol oral contrast agent prior to CT scan"
11248582|NCT02542072|BG000|Baseline|Comfilcon A, Then Samfilcon A|"Randomized participants who wore the comfilcon A lens pair for one month, then samfilcon A lens pair during the cross over study.~comfilcon A: contact lenses~samfilcon A: contact lenses"
11248583|NCT02542072|BG001|Baseline|Samfilcon A, Then Comfilcon A|"Randomized participants who wore the samfilcon A lens pair for one month, then comfilcon A lens pair during the cross over study.~comfilcon A: contact lenses~samfilcon A: contact lenses"
11248584|NCT02542072|BG002|Baseline|Total|Total of all reporting groups
11248585|NCT02542072|FG000|Participant Flow|Comfilcon A, Then Samfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.~comfilcon A: contact lens~samfilcon A: contact lens"
10820281|NCT00056316|BG002|Baseline|Total|Total of all reporting groups
11248586|NCT02542072|FG001|Participant Flow|Samfilcon A, Then Comfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.~samfilcon A: contact lens~comfilcon A: contact lens"
11248587|NCT02542072|OG000|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
11248588|NCT02542072|OG001|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248589|NCT02542072|OG002|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248590|NCT02542072|OG003|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248591|NCT02542072|OG004|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248592|NCT02542072|OG000|Outcome|Comfilcon A (Day 3)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248593|NCT02542072|OG001|Outcome|Samfilcon A (Day 3)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248594|NCT02542072|OG002|Outcome|Comfilcon A (Day 12)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248595|NCT02542072|OG003|Outcome|Samfilcon A (Day 12)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248596|NCT02542072|OG004|Outcome|Comfilcon A (Day 26)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248597|NCT02542072|OG005|Outcome|Samfilcon A (Day 26)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248598|NCT02542072|OG000|Outcome|Habitual Lenses (Baseline)|Habitual data were collected of participants before lens dispensed.
11248599|NCT02542072|OG000|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248600|NCT02542072|OG001|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248601|NCT02542072|OG002|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248602|NCT02542072|OG003|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248603|NCT02542072|OG004|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248604|NCT02542072|OG005|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248605|NCT02542072|OG000|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248606|NCT02542072|OG001|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248607|NCT02542072|OG002|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248608|NCT02542072|OG003|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248609|NCT02542072|EG000|Reported Event|Comfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
11248610|NCT02542072|EG001|Reported Event|Samfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
11248611|NCT02542150|BG000|Baseline|Acetate Arm|"Placebo for 1 hour, then Acetate for 1 hour.~IV acetate given during magnetic resonance scan~acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan"
11248612|NCT02542150|BG001|Baseline|Alcohol Arm|"Placebo for 1 hour, then alcohol (given as a single dose with jello).~jello given before magnetic resonance scan~alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan."
11248613|NCT02542150|BG002|Baseline|Total|Total of all reporting groups
11248614|NCT02542150|FG000|Participant Flow|Acetate Arm|"Placebo for 1 hour, then Acetate for 1 hour~IV acetate given during magnetic resonance scan.~acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan"
11248615|NCT02542150|FG001|Participant Flow|Alcohol Arm|"Placebo for 1 hour, then Alcohol (given as a single dose of jello).~jello given before magnetic resonance scan~alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan."
11248616|NCT02542150|OG000|Outcome|Acetate Arm|"IV acetate given during magnetic resonance scan~acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan"
11248617|NCT02542150|OG001|Outcome|IV Placebo (Acetate Arm)|Placebo given before Acetate.
11248618|NCT02542150|OG002|Outcome|Alcohol Arm|"jello shots given before magnetic resonance scan~alcohol: a jello shot containing alcohol, a jello shot containing no alcohol, fMRI scan."
11248619|NCT02542150|OG003|Outcome|Oral Placebo (Alcohol Arm)|Placebo given before Alcohol.
11248620|NCT02542150|EG000|Reported Event|Acetate Arm|"IV acetate given during magnetic resonance scan~acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan"
11248621|NCT02542150|EG001|Reported Event|IV Placebo (Acetate Arm)|Placebo given before Acetate.
11248622|NCT02542150|EG002|Reported Event|Alcohol Arm|"jello given before magnetic resonance scan~alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan."
11248623|NCT02542150|EG003|Reported Event|Oral Placebo (Alcohol Arm)|Placebo given before Alcohol.
11248624|NCT02542280|BG000|Baseline|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248625|NCT02542280|BG001|Baseline|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248626|NCT02542280|BG002|Baseline|Total|Total of all reporting groups
11248627|NCT02542280|FG000|Participant Flow|Endometrial Injury|"Endometrial injury during ovarian stimulation cycle combined with intrauterine insemination.~endometrial injury: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248628|NCT02542280|FG001|Participant Flow|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248629|NCT02542280|OG000|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248630|NCT02542280|OG001|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248631|NCT02542280|EG000|Reported Event|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248632|NCT02542280|EG001|Reported Event|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
11248633|NCT02542410|BG000|Baseline|Control|"Norethindrone acetate 5 mg po daily x 6 months~Norethindrone acetate"
11248634|NCT02542410|BG001|Baseline|Experimental|"cabergoline 0.5 mg PO twice weekly x 6 months~Cabergoline"
11248635|NCT02542410|BG002|Baseline|Total|Total of all reporting groups
11248636|NCT02542410|FG000|Participant Flow|Norethindrone Acetate 5 mg Daily|"Norethindrone acetate 5 mg po daily x 6 months~Norethindrone acetate"
11248637|NCT02542410|FG001|Participant Flow|Cabergoline 0.5 mg Twice Weekly|"cabergoline 0.5 mg PO twice weekly x 6 months~Cabergoline"
11248638|NCT02542410|OG000|Outcome|Norethindrone Acetate 5 mg|"Norethindrone acetate 5 mg po daily x 6 months~Norethindrone acetate"
11248639|NCT02542410|OG001|Outcome|Cabergoline 0.5 mg|"cabergoline 0.5 mg PO twice weekly x 6 months~Cabergoline"
11248640|NCT02542410|EG000|Reported Event|Control|"Norethindrone acetate 5 mg po daily x 6 months~Norethindrone acetate"
10969686|NCT00907088|EG000|Reported Event|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
10969687|NCT00907088|EG001|Reported Event|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
10969688|NCT00907101|BG000|Baseline|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
10969689|NCT00907101|FG000|Participant Flow|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
10820282|NCT00056316|FG000|Participant Flow|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
10820283|NCT00056316|FG001|Participant Flow|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
10969690|NCT00907101|OG000|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
10969691|NCT00907101|EG000|Reported Event|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
10969692|NCT00907153|BG000|Baseline|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
10969693|NCT00907153|BG001|Baseline|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
10969694|NCT00907153|BG002|Baseline|Total|Total of all reporting groups
10969695|NCT00907153|FG000|Participant Flow|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
10969696|NCT00907153|FG001|Participant Flow|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
10969697|NCT00907153|OG000|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
10969698|NCT00907153|OG001|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
10969699|NCT00907153|EG000|Reported Event|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
10969700|NCT00907153|EG001|Reported Event|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
10969701|NCT00907257|BG000|Baseline|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
11248641|NCT02542410|EG001|Reported Event|Experimental|"cabergoline 0.5 mg PO twice weekly x 6 months~Cabergoline"
11248642|NCT02542462|BG000|Baseline|Rotarix® Alone|"monovalent rotavirus vaccine (Rotarix®, RV1)~Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone"
11248643|NCT02542462|BG001|Baseline|Rotarix®,With Other Routine Vaccines|"monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations~Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248644|NCT02542462|BG002|Baseline|RotaTeq®, Alone|"pentavalent rotavirus vaccine (RotaTeq®, RV5)~RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone"
11248645|NCT02542462|BG003|Baseline|RotaTeq®,With Other Routine Vaccines|"pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations~RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248646|NCT02542462|BG004|Baseline|Total|Total of all reporting groups
11248647|NCT02542462|FG000|Participant Flow|Rotarix® Alone|"monovalent rotavirus vaccine (Rotarix®, RV1)~Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone"
11248648|NCT02542462|FG001|Participant Flow|Rotarix®,With Other Routine Vaccines|"monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations~Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248649|NCT02542462|FG002|Participant Flow|RotaTeq®, Alone|"pentavalent rotavirus vaccine (RotaTeq®, RV5)~RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone"
11248650|NCT02542462|FG003|Participant Flow|RotaTeq®,With Other Routine Vaccines|"pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations~RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248651|NCT02542462|OG000|Outcome|Rotarix® Alone|"monovalent rotavirus vaccine (Rotarix®, RV1)~Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone"
11248652|NCT02542462|OG001|Outcome|Rotarix®,With Other Routine Vaccines|"monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations~Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248653|NCT02542462|OG002|Outcome|RotaTeq®, Alone|"pentavalent rotavirus vaccine (RotaTeq®, RV5)~RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone"
11248654|NCT02542462|OG003|Outcome|RotaTeq®,With Other Routine Vaccines|"pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations~RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248655|NCT02542462|OG000|Outcome|All Study Participants|Infants were randomized to one of four arms: monovalent rotavirus vaccine (Rotarix(r) RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq(r) RV5) alone, or RV5 with other recommended vaccines
11248656|NCT02542462|EG000|Reported Event|Rotarix® Alone|"monovalent rotavirus vaccine (Rotarix®, RV1)~Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone"
11248657|NCT02542462|EG001|Reported Event|Rotarix®,With Other Routine Vaccines|"monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations~Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248658|NCT02542462|EG002|Reported Event|RotaTeq®, Alone|"pentavalent rotavirus vaccine (RotaTeq®, RV5)~RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone"
11248659|NCT02542462|EG003|Reported Event|RotaTeq®,With Other Routine Vaccines|"pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations~RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines"
11248660|NCT02542605|BG000|Baseline|PACAP-38 Challenge Agent|"In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 pmol/kg/minute PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined.~PACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase."
11248661|NCT02542605|FG000|Participant Flow|PACAP-38 Challenge Agent|"In Part A, cohorts 1 to 4 (of 2 to 5 participants each) sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 over 2.5, 5, 7.5 and 10 minutes, respectively. Dose selection in Part A enabled the dose for Part B to be determined.~PACAP-38 naïve participants entered the study at Part B. On day 1 of the Part B challenge phase participants received the dose of PACAP-38 determined from Part A of the study: 100 pmol/kg (administered as 10 pmol/kg/minute PACAP-38 over 10 minutes). Responders who experienced a MLA within 24 hours were screened for the randomization phase."
11248662|NCT02542605|FG001|Participant Flow|Placebo|Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
11248663|NCT02542605|FG002|Participant Flow|Erenumab|Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
11248664|NCT02542605|OG000|Outcome|Placebo|Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
11248665|NCT02542605|OG001|Outcome|Erenumab|Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
11248666|NCT02542605|OG000|Outcome|Erenumab|Participants were randomized to receive 140 mg erenumab by intravenous administration over 30 minutes on day 1 of Part B randomization phase. On day 8, participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.
11248667|NCT02542605|EG000|Reported Event|Placebo Day 1-7|Participants were randomized to receive matching erenumab placebo intravenously over 30 minutes on study day 1 of Part B randomization phase.
11248668|NCT02542605|EG001|Reported Event|Erenumab Day 1-7|Participants were randomized to receive 140 mg erenumab intravenously over 30 minutes on study day 1 of Part B randomization phase.
11248669|NCT02542605|EG002|Reported Event|Placebo Day 8-EOS|On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received matching erenumab placebo on day 1. Participants were followed up for 11 weeks to EOS.
11248670|NCT02542605|EG003|Reported Event|Erenumab Day 8-EOS|On day 8 of Part B randomization phase, participants were administered 100 pmol/kg of PACAP-38, having received 140 mg erenumab intravenously on day 1. Participants were followed up for 11 weeks to EOS.
11248671|NCT02542631|BG000|Baseline|Bolus Insulin Patch|Experimental Treatment Arm
11248672|NCT02542631|BG001|Baseline|Insulin Pen|Comparator Treatment Arm
11248673|NCT02542631|BG002|Baseline|Total|Total of all reporting groups
11248674|NCT02542631|FG000|Participant Flow|Bolus Insulin Patch|Experimental Treatment Arm
11248675|NCT02542631|FG001|Participant Flow|Insulin Pen|Comparator Treatment Arm
11248676|NCT02542631|OG000|Outcome|Bolus Insulin Patch|Experimental Treatment Arm
11248677|NCT02542631|OG001|Outcome|Insulin Pen|Comparator Treatment Arm
11248678|NCT02542631|EG000|Reported Event|Bolus Insulin Patch|Experimental Treatment Arm
11248679|NCT02542631|EG001|Reported Event|Insulin Pen|Comparator Treatment Arm
11248680|NCT02542761|BG000|Baseline|Entire Study Population|Includes groups studying CFPF first and FPF first.
11248681|NCT02542761|FG000|Participant Flow|CFPF First, Then FPF|"After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF).~Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot.~Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate."
11248682|NCT02542761|FG001|Participant Flow|FPF First, Then CFPF|"After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF).~Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot.~Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate."
11248683|NCT02542761|OG000|Outcome|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
10820284|NCT00056316|OG000|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
10820285|NCT00056316|OG001|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
11213542|NCT02287467|EG000|Reported Event|Arm A: hIVIG|"Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Intravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)"
11213543|NCT02287467|EG001|Reported Event|Arm B: Placebo|"Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.~Placebo for IVIG: Administered IV as 500 mL of normal saline"
11213544|NCT02287610|BG000|Baseline|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
11213545|NCT02287610|FG000|Participant Flow|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
11213546|NCT02287610|OG000|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
11213547|NCT02287610|EG000|Reported Event|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
11213548|NCT02287623|BG000|Baseline|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
11213549|NCT02287623|BG001|Baseline|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
11213550|NCT02287623|BG002|Baseline|Total|Total of all reporting groups
11213551|NCT02287623|FG000|Participant Flow|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline."
11213552|NCT02287623|FG001|Participant Flow|Bupivacaine TAP|Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
11213553|NCT02287623|OG000|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
11213554|NCT02287623|OG001|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
11213555|NCT02287623|EG000|Reported Event|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
11213556|NCT02287623|EG001|Reported Event|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
11213557|NCT02287675|BG000|Baseline|Lymphoseek|Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
11213558|NCT02287675|BG001|Baseline|Sulfur Colloid|"Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:~In adults, to assist in the:~localization of lymph nodes draining a primary tumor in patients with~breast cancer or malignant melanoma when used with a hand-held gamma counter.~evaluation of peritoneovenous (LeVeen) shunt patency in adults."
11213559|NCT02287675|BG002|Baseline|Total|Total of all reporting groups
11213560|NCT02287675|FG000|Participant Flow|Sulfur Colloid|"Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:~In adults, to assist in the:~localization of lymph nodes draining a primary tumor in patients with~breast cancer or malignant melanoma when used with a hand-held gamma counter.~evaluation of peritoneovenous (LeVeen) shunt patency in adults."
11213561|NCT02287675|FG001|Participant Flow|Lymphoseek|Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
11213562|NCT02287675|OG000|Outcome|Lymphoseek|Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
11248684|NCT02542761|OG001|Outcome|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
11248685|NCT02542761|EG000|Reported Event|Carbon Fiber Prosthetic Foot (CFPF)|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
11248686|NCT02542761|EG001|Reported Event|Fiberglass Prosthetic Foot (FPF)|The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
11248687|NCT02542865|BG000|Baseline|Fortified Malt Based Food Plus Dietary Counselling|In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs [legally acceptable representative]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.
11248688|NCT02542865|BG001|Baseline|Dietary Counselling Only|In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
11248689|NCT02542865|BG002|Baseline|Total|Total of all reporting groups
11248690|NCT02542865|FG000|Participant Flow|Fortified Malt Based Food Plus Dietary Counselling|In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs [legally acceptable representative]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.
11248691|NCT02542865|FG001|Participant Flow|Dietary Counselling Only|In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
11248692|NCT02542865|OG000|Outcome|Fortified Malt Based Food Plus Dietary Counselling|In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs [legally acceptable representative]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.
11248693|NCT02542865|OG001|Outcome|Dietary Counselling Only|In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
11248694|NCT02542865|EG000|Reported Event|Fortified Malt Based Food Plus Dietary Counselling|In this group, participants received fortified malt based food, 27 grams (g) powder made up in 150 milliliters (mL) lukewarm water, twice daily (during school days first dose was given as soon as the participants entered the school and the second dose just prior to school dismissal and during holidays, first dose was provided in the morning and the second dose administered in the evening, by parents/LARs [legally acceptable representative]) for 9 months. Dietary counseling was provided to both participants and parents/LARs separately in 2 mandatory sessions, which were followed up in 5 follow up sessions.
11248695|NCT02542865|EG001|Reported Event|Dietary Counselling Only|In this group, only dietary counseling was provided to both participants and parents/LAR. This was matched to test group (fortified malt based product plus dietary counselling) with respect to quality, content and duration.
11248696|NCT02542943|BG000|Baseline|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248697|NCT02542943|BG001|Baseline|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248698|NCT02542943|BG002|Baseline|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248699|NCT02542943|BG003|Baseline|Total|Total of all reporting groups
11248700|NCT02542943|FG000|Participant Flow|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate [KOX], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248701|NCT02542943|FG001|Participant Flow|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248702|NCT02542943|FG002|Participant Flow|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248703|NCT02542943|OG000|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248704|NCT02542943|OG001|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248705|NCT02542943|OG002|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248706|NCT02542943|OG000|Outcome|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248707|NCT02542943|EG000|Reported Event|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248708|NCT02542943|EG001|Reported Event|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248709|NCT02542943|EG002|Reported Event|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11248710|NCT02543203|BG000|Baseline|A/C (Reconnect/Comparator)|"Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning.~Aromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night."
11248711|NCT02543203|BG001|Baseline|C/A (Comparator/Reconnect)|"Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning.~Aromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night."
11248712|NCT02543203|BG002|Baseline|Total|Total of all reporting groups
11248713|NCT02543203|FG000|Participant Flow|Reconnect, Then Comparator|"Participants received Reconnect each morning and evening for 3-months and then after a 1-month washout they received the comparator oil. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute.~In the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night."
11248714|NCT02543203|FG001|Participant Flow|Coconut Oil Comparator, Then Reconnect|"Participants received the comparator oil each morning and evening for 3-months and then after a 1-month washout they received Reconnect. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute.~In the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night."
11248715|NCT02543203|OG000|Outcome|Subjects Received Re-Connect Then the Comparator Oil Blend|Subjects were randomized to order. Twelve subjects were randomized to Re-connect for the first 3-months, then after the one-month washout they received the coconut oil comparator during the last 3-months. The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment)
11248716|NCT02543203|OG001|Outcome|Subjects Revieved the Comparator Oil Blend and Then Re-Connnec|Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect (last 3-months).The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment)
11248717|NCT02543203|OG000|Outcome|Subjects Received Re-Connect Then the Comparator Oil Blend|Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The CSHQ was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248718|NCT02543203|OG001|Outcome|Subjects Received the Comparator Oil Blend and Then Re-connnec|Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect (last 3-months).The CSHQ was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248719|NCT02543203|OG000|Outcome|Subjects Received Re-Connect Then the Comparator Oil Blend|Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The PRAS-ASD was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248720|NCT02543203|OG001|Outcome|Subjects Revieved the Comparator Oil Blend and Then Re-Connnec|Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The PRAS-ASD was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248721|NCT02543203|OG000|Outcome|Subjects Received Re-connect Then the Comparator Oil Blend|Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.The DDCGAS was administered at the Baseline Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248722|NCT02543203|OG001|Outcome|Subjects Received the Comparator Oil Blend and Then Re-connnec|Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.The DDCGAS was administered at the Baseline Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).
11248723|NCT02543203|OG000|Outcome|Subjects Received Re-connect Then the Comparator Oil Blend|Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.Adverse events were queried by the study physician at all study visits. Safety population included all participants who received one dose of study IP.
11248724|NCT02543203|OG001|Outcome|Subjects Received the Comparator Oil Blend and Then RE-connect|Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect during the last 3-months. Adverse events were queried by the study physician at all study visits.
11248725|NCT02543203|EG000|Reported Event|Reconnect|Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the Reconnect group.
11248726|NCT02543203|EG001|Reported Event|Coconut Oil Blend (Comparator)|Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the coconut oil comparator group.
11248727|NCT02543294|BG000|Baseline|Intervention (Weaning)|Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
11248728|NCT02543294|FG000|Participant Flow|Intervention (Weaning)|Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
11248729|NCT02543294|OG000|Outcome|Intervention (Weaning)|"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"
11248730|NCT02543294|OG000|Outcome|Intervention (Weaning)|Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
11248731|NCT02543294|EG000|Reported Event|Intervention (Weaning)|Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)
11248732|NCT02543346|BG000|Baseline|All Study Participants|Includes all participants at the EEU and BRC sites. All participants were randomized to receive both interventions (Cetirizine 10 mg and Placebo).
11248733|NCT02543346|FG000|Participant Flow|EEU: Cetirizine First, Then Placebo|At the EEU, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point.
11248734|NCT02543346|FG001|Participant Flow|EEU: Placebo First, Then Cetirizine|At the EEU, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point.
11248735|NCT02543346|FG002|Participant Flow|BRC: Cetirizine First, Then Placebo|At the BRC, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point.
11248736|NCT02543346|FG003|Participant Flow|BRC: Placebo First, Then Cetirizine|At the BRC, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point.
11248737|NCT02543346|OG000|Outcome|EEU Placebo|
11248738|NCT02543346|OG001|Outcome|BRC Placebo|
11248739|NCT02543346|OG002|Outcome|EEU Cetirizine|
11248740|NCT02543346|OG003|Outcome|BRC Cetirizine|
11248741|NCT02543346|EG000|Reported Event|EEU Placebo|Participants in the EEU who received one matching placebo at either the first or second treatment visit.
11248742|NCT02543346|EG001|Reported Event|BRC Placebo|Participants in the BRC who received one matching placebo at either the first or second treatment visit.
10969702|NCT00907257|BG001|Baseline|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
11248743|NCT02543346|EG002|Reported Event|EEU Cetirizine|Participants in the EEU who received Cetirizine at either the first or second treatment visit.
11248744|NCT02543346|EG003|Reported Event|BRC Cetirizine|Participants in the BRC who received Cetirizine at either the first or second treatment visit.
11248745|NCT02543398|BG000|Baseline|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not dissolve by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called Ridge preservation~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248746|NCT02543398|BG001|Baseline|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. Spontaneous Healing (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248747|NCT02543398|BG002|Baseline|Total|Total of all reporting groups
11248748|NCT02543398|FG000|Participant Flow|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not dissolve by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called Ridge preservation~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248749|NCT02543398|FG001|Participant Flow|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. Spontaneous Healing (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248750|NCT02543398|OG000|Outcome|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not dissolve by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called Ridge preservation~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248751|NCT02543398|OG001|Outcome|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. Spontaneous Healing (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248752|NCT02543398|EG000|Reported Event|Ridge Preservation|"The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not dissolve by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called Ridge preservation~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248753|NCT02543398|EG001|Reported Event|No Ridge Preservation|"The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. Spontaneous Healing (No ridge preservation is performed)~Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site."
11248754|NCT02543437|BG000|Baseline|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
11248755|NCT02543437|FG000|Participant Flow|Trident Acetabular X3 Insert|Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
11248756|NCT02543437|OG000|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
10969703|NCT00907257|BG002|Baseline|Total|Total of all reporting groups
11248757|NCT02543437|EG000|Reported Event|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
11248758|NCT02543528|BG000|Baseline|All Dispensed Subjects|All subjects dispensed at least 1 study lens.
11248759|NCT02543528|FG000|Participant Flow|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
11248760|NCT02543528|FG001|Participant Flow|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
11248761|NCT02543528|FG002|Participant Flow|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
11248762|NCT02543528|FG003|Participant Flow|Etafilcon A (Resuable)|Subjects that were randomized to receive the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
11248763|NCT02543528|FG004|Participant Flow|Etafilcon A (1-Day)|All subjects wore the etafilcon A 1-Day contact lens during the 2-week adaptation period.
10969704|NCT00907257|FG000|Participant Flow|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
10969705|NCT00907257|FG001|Participant Flow|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
10969706|NCT00907257|OG000|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
11248764|NCT02543528|OG000|Outcome|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
11248765|NCT02543528|OG001|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
11248766|NCT02543528|OG002|Outcome|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
11248767|NCT02543528|OG003|Outcome|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
11248768|NCT02543528|OG000|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
11248769|NCT02543528|OG001|Outcome|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
11248770|NCT02543528|OG000|Outcome|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
11248771|NCT02543528|EG000|Reported Event|Etafilcon A (1-Day)|All subject wore the etafilcon A (1-Day) contact lens throughout the entire duration of the adaptation period (14-Days).
11248772|NCT02543528|EG001|Reported Event|Investigational Lens 1|Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
11248773|NCT02543528|EG002|Reported Event|Investigational Lens 2|Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
11248774|NCT02543528|EG003|Reported Event|Investigational Lens 3|Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
11248775|NCT02543528|EG004|Reported Event|Etafilcon A (Resuable)|Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
11248776|NCT02543554|BG000|Baseline|Pre-intervention Group|mechanically ventilated patients before implementation of ED lung protective ventilation
11248777|NCT02543554|BG001|Baseline|Intervention Group|"mechanically ventilated patients after implementation of ED lung protective ventilation~lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia."
11248778|NCT02543554|BG002|Baseline|Total|Total of all reporting groups
11248779|NCT02543554|FG000|Participant Flow|Pre-intervention Group|mechanically ventilated patients before implementation of ED lung protective ventilation
10820286|NCT00056316|EG000|Reported Event|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
11248780|NCT02543554|FG001|Participant Flow|Intervention Group|"mechanically ventilated patients after implementation of ED lung protective ventilation~lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia."
11248781|NCT02543554|OG000|Outcome|Pre-intervention Group|Before implementation of ED lung protection
11248782|NCT02543554|OG001|Outcome|Intervention Group|after implementation of ED lung protective ventilation
11248783|NCT02543554|EG000|Reported Event|Pre-intervention Group|mechanically ventilated patients before implementation of ED lung protective ventilation
11248784|NCT02543554|EG001|Reported Event|Intervention Group|"mechanically ventilated patients after implementation of ED lung protective ventilation~lung protective ventilation: Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia."
11248785|NCT02543658|BG000|Baseline|Neostigmine|"Intramuscular injection of neostigmine on the basis of conventional conservative treatment~Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.~Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines."
11248786|NCT02543658|BG001|Baseline|Conservative Treatment|Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
11248787|NCT02543658|BG002|Baseline|Total|Total of all reporting groups
11248788|NCT02543658|FG000|Participant Flow|Neostigmine|"Intramuscular injection of neostigmine~Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.~Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage."
11248789|NCT02543658|FG001|Participant Flow|The Traditional Treatment|Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
11248790|NCT02543658|OG000|Outcome|Neostigmine|"Intramuscular injection of neostigmine on the basis of conventional conservative treatment~Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.~Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines."
11248791|NCT02543658|OG001|Outcome|Conservative Treatment|"Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.~Conservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines."
11248792|NCT02543658|OG001|Outcome|Conservative Treatment|Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
11248793|NCT02543658|EG000|Reported Event|Neostigmine|"Intramuscular injection of neostigmine~Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.~Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage."
11248794|NCT02543658|EG001|Reported Event|The Traditional Treatment|Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.
11248795|NCT02543723|BG000|Baseline|Nurse Coach Intervention|The nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs. The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics. The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience. Patients received weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period.
11248796|NCT02543723|BG001|Baseline|Control|Patients received standard of care.
11248797|NCT02543723|BG002|Baseline|Total|Total of all reporting groups
11248798|NCT02543723|FG000|Participant Flow|Nurse Coach Intervention|The nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs. The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics. The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience. Patients received weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period.
11248799|NCT02543723|FG001|Participant Flow|Control|Patients received standard of care at this Regional Cancer Center.
11248800|NCT02543723|OG000|Outcome|Nurse Coach Intervention|Using the SEAMS to measure baseline and final (at 6 months)
11248801|NCT02543723|OG001|Outcome|Control|Using the SEAMS to measure baseline and final (at 6 months)
11248802|NCT02543723|OG000|Outcome|Nurse Coach Intervention|Using CHLT-30 to assess cancer health literacy in baseline and final (at 6 months)
11248803|NCT02543723|OG001|Outcome|Control|Using CHLT-30 to assess cancer health literacy in baseline and final (at 6 months)
11248804|NCT02543723|EG000|Reported Event|Nurse Coach Intervention|The nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs. The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics. The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience. Patients received weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period.
11248805|NCT02543723|EG001|Reported Event|Control|Patients received standard of care.
11248806|NCT02543801|BG000|Baseline|Hip Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248807|NCT02543801|BG001|Baseline|Hip Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248808|NCT02543801|BG002|Baseline|Knee Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248809|NCT02543801|BG003|Baseline|Knee Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248810|NCT02543801|BG004|Baseline|Total|Total of all reporting groups
11248811|NCT02543801|FG000|Participant Flow|Hip Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248812|NCT02543801|FG001|Participant Flow|Hip Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248813|NCT02543801|FG002|Participant Flow|Knee Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248814|NCT02543801|FG003|Participant Flow|Knee Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248815|NCT02543801|OG000|Outcome|Hip Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248816|NCT02543801|OG001|Outcome|Hip Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248817|NCT02543801|OG002|Outcome|Knee Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248818|NCT02543801|OG003|Outcome|Knee Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248819|NCT02543801|EG000|Reported Event|Hip Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248820|NCT02543801|EG001|Reported Event|Hip Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248821|NCT02543801|EG002|Reported Event|Knee Cohort Liposomal Bupivacaine|"Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac~Liposomal Bupivacaine: Periarticular injection~Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248822|NCT02543801|EG003|Reported Event|Knee Cohort Ropivacaine|"Ropivacaine Clonidine Epinephrine Ketorolac~Ropivacaine: Periarticular injection~Clonidine: Included as an element of both interventions as a standard of care periarticular injection~Ketorolac: Included as an element of both interventions as a standard of care periarticular injection~Epinephrine: Included as an element of both interventions as a standard of care periarticular injection"
11248823|NCT02543840|BG000|Baseline|Veteran Participants|In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
11248824|NCT02543840|BG001|Baseline|Provider Participants|In this stepped wedge design, BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.
11248825|NCT02543840|BG002|Baseline|Total|Total of all reporting groups
11248826|NCT02543840|FG000|Participant Flow|Veteran Participants|In this stepped wedge design that is not a randomized control trial (RCT), those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
11248827|NCT02543840|FG001|Participant Flow|Provider Participants|In this stepped wedge design that is not a randomized control trial (RCT), BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.
11248828|NCT02543840|OG000|Outcome|Veteran Participants|In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
11248829|NCT02543840|OG000|Outcome|Provider Participants|In this stepped wedge design, BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.
11248830|NCT02543840|OG000|Outcome|Eligible Veterans|In this stepped wedge design, all eligible BHIP team-treated veterans were utilized for hospitalization rate analyses. Primary analyses were within-subject.
11248831|NCT02543840|EG000|Reported Event|Veteran Participants|Veterans in quasi-experimental stepped wedge design.
11248832|NCT02543840|EG001|Reported Event|Provider Participants|Providers in mental health (MH) clinics who participated in survey.
11248833|NCT02543892|BG000|Baseline|Adult 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248834|NCT02543892|BG001|Baseline|Adult 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
10820287|NCT00056316|EG001|Reported Event|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
11248835|NCT02543892|BG002|Baseline|Adult Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248836|NCT02543892|BG003|Baseline|Adult Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248837|NCT02543892|BG004|Baseline|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248838|NCT02543892|BG005|Baseline|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248839|NCT02543892|BG006|Baseline|Toddler Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248840|NCT02543892|BG007|Baseline|Toddler Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248841|NCT02543892|BG008|Baseline|Total|Total of all reporting groups
11248842|NCT02543892|FG000|Participant Flow|Adult 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248843|NCT02543892|FG001|Participant Flow|Adult 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248844|NCT02543892|FG002|Participant Flow|Adult Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248845|NCT02543892|FG003|Participant Flow|Adult Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248846|NCT02543892|FG004|Participant Flow|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248847|NCT02543892|FG005|Participant Flow|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248848|NCT02543892|FG006|Participant Flow|Toddler Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248849|NCT02543892|FG007|Participant Flow|Toddler Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248850|NCT02543892|OG000|Outcome|Adult 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248851|NCT02543892|OG001|Outcome|Adult 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248852|NCT02543892|OG002|Outcome|Adult Placebo|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
10820288|NCT00056407|BG000|Baseline|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
11248853|NCT02543892|OG000|Outcome|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248854|NCT02543892|OG001|Outcome|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248855|NCT02543892|OG002|Outcome|Toddler Placebo|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248856|NCT02543892|OG002|Outcome|Adult Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248857|NCT02543892|OG003|Outcome|Adult Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248858|NCT02543892|OG004|Outcome|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248859|NCT02543892|OG005|Outcome|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248860|NCT02543892|OG006|Outcome|Toddler Placebo Low Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248861|NCT02543892|OG007|Outcome|Toddler Placebo High Dose|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248862|NCT02543892|OG003|Outcome|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248863|NCT02543892|OG004|Outcome|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248864|NCT02543892|OG005|Outcome|Toddler Placebo|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248865|NCT02543892|EG000|Reported Event|Adult 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248866|NCT02543892|EG001|Reported Event|Adult 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248867|NCT02543892|EG002|Reported Event|Adult Placebo|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248868|NCT02543892|EG003|Reported Event|Toddler 0.6mg PATH-wSP|"Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248869|NCT02543892|EG004|Reported Event|Toddler 1.0 mg PATH-wSP|"Two 1 mg doses of PATH-wSP with a 28 day interval between doses~PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide"
11248870|NCT02543892|EG005|Reported Event|Toddler Placebo|"Two injections of normal saline with a 28 day interval between injections~Placebo: Normal Saline"
11248871|NCT02543918|BG000|Baseline|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248872|NCT02543918|BG001|Baseline|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248873|NCT02543918|BG002|Baseline|Total|Total of all reporting groups
11248874|NCT02543918|FG000|Participant Flow|Ixekizumab + Boostrix® + Pneumovax®23|"Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.~Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2."
11248875|NCT02543918|FG001|Participant Flow|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
11248876|NCT02543918|OG000|Outcome|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248877|NCT02543918|OG001|Outcome|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248878|NCT02543918|EG000|Reported Event|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248879|NCT02543918|EG001|Reported Event|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
11248880|NCT02544113|BG000|Baseline|Thymo|"Subjects randomized to the (Delay CNI) group will be treated with Thymoglobulin® (total dose of 4.5 mg/kg) administered in three doses; (each dose being 1.5 mg/kg - administered Day 0 [after transplant], Day 2, and Day 4 post transplant), along with CNI delay for 10 days. CNI will be initiated on postoperative (post-transplant) Day 10. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Thymoglobulin: Treatment with thymoglobulin and delayed CNI post OLT"
11248881|NCT02544113|BG001|Baseline|Control|"Subjects randomized to the (Early CNI) group (Control group) will receive no antibody therapy for induction and will start CNI therapy on postoperative (post-transplant) Day 2. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Placebo: Normal transplant immunosuppression"
11248882|NCT02544113|BG002|Baseline|Total|Total of all reporting groups
11248883|NCT02544113|FG000|Participant Flow|Thymo|"Subjects randomized to the (Delay CNI) group will be treated with Thymoglobulin® (total dose of 4.5 mg/kg) administered in three doses; (each dose being 1.5 mg/kg - administered Day 0 [after transplant], Day 2, and Day 4 post transplant), along with CNI delay for 10 days. CNI will be initiated on postoperative (post-transplant) Day 10. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Thymoglobulin: Treatment with thymoglobulin and delayed CNI post OLT"
11248884|NCT02544113|FG001|Participant Flow|Control|"Subjects randomized to the (Early CNI) group (Control group) will receive no antibody therapy for induction and will start CNI therapy on postoperative (post-transplant) Day 2. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Placebo: Normal transplant immunosuppression"
11248885|NCT02544113|OG000|Outcome|Thymo|"Subjects randomized to the (Delay CNI) group will be treated with Thymoglobulin® (total dose of 4.5 mg/kg) administered in three doses; (each dose being 1.5 mg/kg - administered Day 0 [after transplant], Day 2, and Day 4 post transplant), along with CNI delay for 10 days. CNI will be initiated on postoperative (post-transplant) Day 10. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Thymoglobulin: Treatment with thymoglobulin and delayed CNI post OLT"
11248886|NCT02544113|OG001|Outcome|Control|"Subjects randomized to the (Early CNI) group (Control group) will receive no antibody therapy for induction and will start CNI therapy on postoperative (post-transplant) Day 2. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Placebo: Normal transplant immunosuppression"
11248887|NCT02544113|EG000|Reported Event|Thymo|"Subjects randomized to the (Delay CNI) group will be treated with Thymoglobulin® (total dose of 4.5 mg/kg) administered in three doses; (each dose being 1.5 mg/kg - administered Day 0 [after transplant], Day 2, and Day 4 post transplant), along with CNI delay for 10 days. CNI will be initiated on postoperative (post-transplant) Day 10. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Thymoglobulin: Treatment with thymoglobulin and delayed CNI post OLT"
11248888|NCT02544113|EG001|Reported Event|Control|"Subjects randomized to the (Early CNI) group (Control group) will receive no antibody therapy for induction and will start CNI therapy on postoperative (post-transplant) Day 2. Subjects will also receive a maintenance immunosuppression regimen of corticosteroids and MMF in accordance with the standard practice at each clinical center.~Placebo: Normal transplant immunosuppression"
11248889|NCT02544152|BG000|Baseline|Placebo|Participants receive 0 mcg capsules twice daily (BID)
11248890|NCT02544152|BG001|Baseline|Lubiprostone|Participants receive 8 mcg lubiprostone capsules BID
11248891|NCT02544152|BG002|Baseline|Total|Total of all reporting groups
11248892|NCT02544152|FG000|Participant Flow|Placebo|Participants receive 0 mcg capsules twice daily (BID)
10820289|NCT00056407|BG001|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
11248893|NCT02544152|FG001|Participant Flow|Lubiprostone|Participants receive 8 mcg lubiprostone capsules BID
11248894|NCT02544152|OG000|Outcome|Placebo|Participants receive 0 mcg capsules twice daily (BID)
10820290|NCT00056407|BG002|Baseline|Total|Total of all reporting groups
10820291|NCT00056407|FG000|Participant Flow|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
10820292|NCT00056407|FG001|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
11248895|NCT02544152|OG001|Outcome|Lubiprostone|Participants receive 8 mcg lubiprostone capsules BID
11248896|NCT02544152|EG000|Reported Event|Placebo|Participants receive 0 mcg capsules twice daily (BID)
11248897|NCT02544152|EG001|Reported Event|Lubiprostone|Participants receive 8 mcg lubiprostone capsules BID
11248898|NCT02544217|BG000|Baseline|SAD Group I|SAD group I: 10mg, 100mg, 800mg
11248899|NCT02544217|BG001|Baseline|SAD Group II|SAD group II: 30mg, 300mg, 2000mg
11248900|NCT02544217|BG002|Baseline|MAD Group III|MAD group III:100mg bis in die (BID)
11248901|NCT02544217|BG003|Baseline|MAD Group IV|MAD group IV: 200mg BID
11248902|NCT02544217|BG004|Baseline|MAD Group V|MAD group V: 400mg BID
11248903|NCT02544217|BG005|Baseline|Placebo|Placebo group
11248904|NCT02544217|BG006|Baseline|Total|Total of all reporting groups
11248905|NCT02544217|FG000|Participant Flow|Single Ascending Group I|"2 alternating groups receiving escalating single doses of active/placebo~KH176~placebo"
11248906|NCT02544217|FG001|Participant Flow|Single Ascending Group II|"2 alternating groups receiving escalating single doses of active/placebo~KH176~placebo"
11248907|NCT02544217|FG002|Participant Flow|Multiple Ascending Group III|"3 multiple escalating groups, receiving active/placebo~KH176~placebo"
11248908|NCT02544217|FG003|Participant Flow|Multiple Ascending Group IV|"3 multiple escalating groups, receiving active/placebo~KH176~placebo"
11248909|NCT02544217|FG004|Participant Flow|Multiple Ascending Group V|"3 multiple escalating groups, receiving active/placebo~KH176~placebo"
11248910|NCT02544217|FG005|Participant Flow|Placebo|Group receiving placebo
11248911|NCT02544217|OG000|Outcome|Group I Placebo|Placebo - single dose
11248912|NCT02544217|OG001|Outcome|Group II Placebo|Placebo - single dose
11248913|NCT02544217|OG002|Outcome|SAD Group I 10mg|10mg KH176 - single dose
11248914|NCT02544217|OG003|Outcome|SAD Group II 30mg|30mg KH176 - single dose
11248915|NCT02544217|OG004|Outcome|SAD Group I 100mg|100mg KH176 - single dose
11248916|NCT02544217|OG005|Outcome|SAD Group II 300mg|300mg KH176 - single dose
11248917|NCT02544217|OG006|Outcome|SAD Group I 800mg|800mg KH176 - single dose
11248918|NCT02544217|OG007|Outcome|SAD Group II 2000mg|2000mg KH176 - single dose
11248919|NCT02544217|OG008|Outcome|Group I Placebo + Food|Placebo + high calorie/high fat breakfast
11248920|NCT02544217|OG009|Outcome|Group I 100mg + Food|100mg KH176 + high calorie/high fat breakfast
11248921|NCT02544217|OG000|Outcome|MAD Group III|MAD group III:100mg BID
11248922|NCT02544217|OG001|Outcome|MAD Group IV|MAD group IV: 200mg BID
11248923|NCT02544217|OG002|Outcome|MAD Group V|MAD group V: 400mg BID
11248924|NCT02544217|OG003|Outcome|Placebo|Mad group: Placebo
11248925|NCT02544217|OG010|Outcome|MAD Group III 200mg|100mg BID/Day (over 7 days)
11248926|NCT02544217|OG011|Outcome|MAD Group IV 400mg|200mg BID/Day (over 7 days)
11248927|NCT02544217|OG012|Outcome|MAD Group V 800mg|400mg BID/Day (over 7 days)
11248928|NCT02544217|OG013|Outcome|Placebo|MAD group: Placebo
11248929|NCT02544217|OG003|Outcome|Placebo|MAD group: Placebo
11248930|NCT02544217|OG003|Outcome|Placebo|MAD Placebo group
11248931|NCT02544217|OG003|Outcome|Placebo|MAD placebo group
11248932|NCT02544217|OG003|Outcome|Placebo|
11248933|NCT02544217|OG003|Outcome|Placebo|MAD group:Placebo
11248934|NCT02544217|OG000|Outcome|SAD Group I Placebo|SAD group I - Placebo
11248935|NCT02544217|OG001|Outcome|SAD Group II Placebo|SAD group II - Placebo
11248936|NCT02544217|OG008|Outcome|Group I Placebo + Food|Placebo - single dose + Food
11248937|NCT02544217|OG009|Outcome|Group II 100mg + Food|100mg KH176 - single dose + Food
11248938|NCT02544217|OG000|Outcome|SAD Group I Placebo|SAD group I Placebo
11248939|NCT02544217|OG001|Outcome|SAD Group II Placebo|SAD group II Placebo
11248940|NCT02544217|OG000|Outcome|SAD Group I 10mg|10mg KH176 - single dose
11248941|NCT02544217|OG001|Outcome|SAD Group II 30mg|30mg KH176 - single dose
11248942|NCT02544217|OG002|Outcome|SAD Group I 100mg|100mg KH176 - single dose
11248943|NCT02544217|OG003|Outcome|SAD Group II 300mg|300mg KH176 - single dose
11248944|NCT02544217|OG004|Outcome|SAD Group I 800mg|800mg KH176 - single dose
11248945|NCT02544217|OG005|Outcome|SAD Group II 2000mg|2000mg KH176 - single dose
11248946|NCT02544217|OG006|Outcome|Group I 100mg + Food|100mg KH176 + high calorie/high fat breakfast
11248947|NCT02544217|OG000|Outcome|Cmax Dose 100mg|Maximum concentration - 100mg
11248948|NCT02544217|OG001|Outcome|Cmax - Dose 200mg|Maximum concentration - 200 mg
11248949|NCT02544217|OG002|Outcome|Cmax - Dose 400mg|Maximum concentration - 400mg
11248950|NCT02544217|OG000|Outcome|Tmax Dose 100mg|Time to Maximum concentration - 100mg
11248951|NCT02544217|OG001|Outcome|Tmax - Dose 200mg|Time to Maximum concentration - 200 mg
11248952|NCT02544217|OG002|Outcome|Tmax - Dose 400mg|Time to Maximum concentration - 400mg
11248953|NCT02544217|OG000|Outcome|Racc Dose 100mg|Accumulation factor - 100mg
11248954|NCT02544217|OG001|Outcome|Racc- Dose 200mg|Accumulation factor - 200 mg
11248955|NCT02544217|OG002|Outcome|Racc - Dose 400mg|Accumulation factor - 400mg
11248956|NCT02544217|OG000|Outcome|AUCtau Dose 100mg|Area under the plasma concentration-time curve during a dose interval- 100mg
11248957|NCT02544217|OG001|Outcome|AUCtau - Dose 200mg|Area under the plasma concentration-time curve during a dose interval - 200 mg
11248958|NCT02544217|OG002|Outcome|AUCtau - Dose 400mg|Area under the plasma concentration-time curve during a dose interval - 400mg
11248959|NCT02544217|OG000|Outcome|MAD Group Dose 100mg|100mg KH176 - Multiple dose: Percentage of administered dose excreted
11248960|NCT02544217|OG001|Outcome|MAD Group - Dose 200mg|200mg KH176 - Multiple dose: Percentage of administered dose excreted
11248961|NCT02544217|OG002|Outcome|MAD Group - Dose 400mg|400mg KH176 - Percentage of administered dose excreted
11248962|NCT02544217|EG000|Reported Event|Group I Placebo|Placebo - single dose
11248963|NCT02544217|EG001|Reported Event|Group II Placebo|Placebo - single dose
11248964|NCT02544217|EG002|Reported Event|SAD Group I 10mg|10mg KH176 - single dose
11248965|NCT02544217|EG003|Reported Event|SAD Group II 30mg|30mg KH176 - single dose
11248966|NCT02544217|EG004|Reported Event|SAD Group I 100mg|100mg KH176 - single dose
11248967|NCT02544217|EG005|Reported Event|SAD Group II 300mg|300mg KH176 - single dose
11248968|NCT02544217|EG006|Reported Event|SAD Group I 800mg|800mg KH176 - single dose
11248969|NCT02544217|EG007|Reported Event|SAD Group II 2000mg|2000mg KH176 - single dose
11248970|NCT02544217|EG008|Reported Event|Group I Placebo + Food|Placebo + high calorie/high fat breakfast
11248971|NCT02544217|EG009|Reported Event|Group I 100mg + Food|100mg KH176 + high calorie/high fat breakfast
11248972|NCT02544217|EG010|Reported Event|MAD Group III 200mg|100mg BID/Day (over 7 days)
11248973|NCT02544217|EG011|Reported Event|MAD Group IV 400mg|200mg BID/Day (over 7 days)
11248974|NCT02544217|EG012|Reported Event|MAD Group V 800mg|400mg BID/Day (over 7 days)
11248975|NCT02544217|EG013|Reported Event|Placebo|Placebo
11248976|NCT02544321|BG000|Baseline|Bromocriptine QR, Then Placebo|4 weeks of investigational drug Bromocriptine QR, then 4 weeks of placebo.
11248977|NCT02544321|BG001|Baseline|Placebo, Then Bromocriptine QR|4 weeks of placebo, then 4 weeks of investigational drug Bromocriptine QR
11248978|NCT02544321|BG002|Baseline|Total|Total of all reporting groups
11248979|NCT02544321|FG000|Participant Flow|Bromocriptine QR, Then Placebo|4 weeks of investigational drug Bromocriptine QR, then 4 weeks of placebo.
11248980|NCT02544321|FG001|Participant Flow|Placebo, Then Bromocriptine QR|4 weeks of placebo, then 4 weeks of investigational drug Bromocriptine QR
11248981|NCT02544321|OG000|Outcome|Bromocriptine QR (Adolescents)|"4 weeks of investigational drug Bromocriptine QR~Bromocriptine"
11248982|NCT02544321|OG001|Outcome|Bromocriptine QR (Adults)|"4 weeks of investigational drug Bromocriptine QR~Bromocriptine"
11248983|NCT02544321|OG002|Outcome|Placebo (Adolescents)|"4 weeks of placebo~Placebo"
11248984|NCT02544321|OG003|Outcome|Placebo (Adults)|"4 weeks of placebo~Placebo"
11248985|NCT02544321|OG001|Outcome|Bromocriptine QR (Adults)|4 weeks of investigational drug Bromocriptine QR
11248986|NCT02544321|OG003|Outcome|Placebo (Adults)|4 weeks of placebo
11248987|NCT02544321|OG000|Outcome|Bromocriptine QR (Adults)|"4 weeks of investigational drug Bromocriptine QR~Bromocriptine"
11248988|NCT02544321|OG001|Outcome|Placebo (Adults)|"4 weeks of placebo~Placebo"
11248989|NCT02544321|OG001|Outcome|Placebo (Adolescents)|"4 weeks of placebo~Placebo"
11248990|NCT02544321|EG000|Reported Event|Bromocriptine QR (Adolescents)|"4 weeks of investigational drug Bromocriptine QR~Bromocriptine"
11248991|NCT02544321|EG001|Reported Event|Bromocriptine QR (Adults)|"4 weeks of investigational drug Bromocriptine QR~Bromocriptine"
11248992|NCT02544321|EG002|Reported Event|Placebo (Adolescents)|"4 weeks of placebo~Placebo"
11248993|NCT02544321|EG003|Reported Event|Placebo (Adults)|"4 weeks of placebo~Placebo"
11248994|NCT02544451|BG000|Baseline|LUM/IVA to LUM/IVA|Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
11248995|NCT02544451|BG001|Baseline|PBO to LUM/IVA|Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
11248996|NCT02544451|BG002|Baseline|Observational Cohort|Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
11248997|NCT02544451|BG003|Baseline|Total|Total of all reporting groups
11248998|NCT02544451|FG000|Participant Flow|Treatment Period 1: LUM/IVA to LUM/IVA|Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
11248999|NCT02544451|FG001|Participant Flow|Treatment Period 1: PBO to LUM/IVA|Participants received placebo (PBO) in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
11249000|NCT02544451|FG002|Participant Flow|Treatment Period 1: Observational Cohort|Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
11249001|NCT02544451|FG003|Participant Flow|Treatment Period 2: LUM/IVA|Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
11249002|NCT02544451|OG000|Outcome|LUM/IVA to LUM/IVA|Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
11249003|NCT02544451|OG001|Outcome|PBO to LUM/IVA|Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
11249004|NCT02544451|OG000|Outcome|LUM/IVA to LUM/IVA|All participants in the LCI set who received LUM/IVA in the parent study.
11249005|NCT02544451|OG001|Outcome|PBO to LUM/IVA|All participants in the LCI set who received PBO in the parent study.
11249006|NCT02544451|OG000|Outcome|LUM/IVA to LUM/IVA|All participants in the FAS who received LUM/IVA in the parent study.
11249007|NCT02544451|OG001|Outcome|PBO to LUM/IVA|All participants in the FAS who received PBO in the parent study.
11249008|NCT02544451|OG000|Outcome|Observational Cohort|Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
11249009|NCT02544451|OG000|Outcome|LUM/IVA to LUM/IVA|All participants who received LUM/IVA in parent study 109.
11249010|NCT02544451|OG001|Outcome|PBO to LUM/IVA|All participants who received PBO in parent study 109.
11249011|NCT02544451|OG000|Outcome|LUM/IVA Overall|All participants who received LUM/IVA in parent study 109, 011B LCI sub-study, or current study.
11249012|NCT02544451|OG000|Outcome|LUM/IVA Overall|All participants who received LUM/IVA in either parent study or current study.
11249013|NCT02544451|OG000|Outcome|Treatment Period 2: LUM/IVA|Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
11249014|NCT02544451|EG000|Reported Event|Treatment Period 1: LUM/IVA to LUM/IVA|Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
11249015|NCT02544451|EG001|Reported Event|Treatment Period 1: PBO to LUM/IVA|Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
11249016|NCT02544451|EG002|Reported Event|Treatment Period 1: Observational Cohort|Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
11249017|NCT02544451|EG003|Reported Event|Treatment Period 2: LUM/IVA|Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
10820293|NCT00056407|OG000|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
10820294|NCT00056407|OG001|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
11249018|NCT02544607|BG000|Baseline|Ketamine|"All eligible participants will receive open label ketamine~Ketamine: Ketamine 0.5mg/kg over 40 minutes IV"
11249019|NCT02544607|FG000|Participant Flow|Ketamine + MRI|"All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging~Ketamine: Ketamine 0.5mg/kg over 40 minutes IV"
11249020|NCT02544607|OG000|Outcome|Ketamine|"All eligible participants will receive open label ketamine~Ketamine: Ketamine 0.5mg/kg over 40 minutes IV"
11249021|NCT02544607|OG000|Outcome|Ketamine + MRI|"All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).~Ketamine: Ketamine 0.5mg/kg over 40 minutes IV~Magnetic Resonance Imaging (MRI): MRI technology will be used before and after ketamine for patients with depression"
11249022|NCT02544607|EG000|Reported Event|Ketamine|"All eligible participants will receive open label ketamine~Ketamine: Ketamine 0.5mg/kg over 40 minutes IV"
11249023|NCT02544633|BG000|Baseline|MET Activating Mutations in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
11249024|NCT02544633|BG001|Baseline|MET Gene Amplifications in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
11249025|NCT02544633|BG002|Baseline|MET Activating Mutations in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
11249026|NCT02544633|BG003|Baseline|MET Gene Amplifications in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
11249027|NCT02544633|BG004|Baseline|Total|Total of all reporting groups
11249028|NCT02544633|FG000|Participant Flow|MET Activating Mutations in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
11249029|NCT02544633|FG001|Participant Flow|MET Gene Amplifications in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
11249030|NCT02544633|FG002|Participant Flow|MET Activating Mutations in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
11249031|NCT02544633|FG003|Participant Flow|MET Gene Amplifications in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
11249032|NCT02544633|OG000|Outcome|MET Activating Mutations in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
11249033|NCT02544633|OG001|Outcome|MET Gene Amplifications in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
11249034|NCT02544633|OG002|Outcome|MET Activating Mutations in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
11249035|NCT02544633|OG003|Outcome|MET Gene Amplifications in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
11249036|NCT02544633|OG000|Outcome|Tablet 750 mg BID C1D1|Tablet formulation, 750 mg, BID, Cycle 1 Day 1
11249037|NCT02544633|OG001|Outcome|Tablet 750 mg BID C1D15|Tablet formulation, 750 mg, BID, Cycle 1 Day 15
11249038|NCT02544633|OG002|Outcome|Soft Gel 1050 mg BID C1D1|Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
11249039|NCT02544633|OG003|Outcome|Soft Gel 1050 mg BID C1D15|Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
11249040|NCT02544633|OG004|Outcome|Tablet 750 mg BID C2D1|Tablet formulation, 750 mg, BID, Cycle 2 Day 1
11249041|NCT02544633|OG005|Outcome|Tablet 750 mg BID C2D15|Tablet formulation, 750 mg, BID, Cycle 2 Day 15
11249042|NCT02544633|OG006|Outcome|Soft Gel 1050 mg BID C2D1|Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
11249043|NCT02544633|OG000|Outcome|MET Activating Mutations|Patients with MET Activating Mutations
11249044|NCT02544633|OG000|Outcome|MET Gene Amplifications|Patients with MET Gene Amplifications
11249045|NCT02544633|OG000|Outcome|MET Activating Mutation|MET Exon 14 deletion mutation
11249046|NCT02544633|OG001|Outcome|MET Gene Amplification|MET activating mutation
11249047|NCT02544633|EG000|Reported Event|MET Activating Mutations in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
11249048|NCT02544633|EG001|Reported Event|MET Gene Amplifications in Tumor Tissue|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
11249049|NCT02544633|EG002|Reported Event|MET Activating Mutations in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
11249050|NCT02544633|EG003|Reported Event|MET Gene Amplifications in ctDNA|MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
11249051|NCT02544633|EG004|Reported Event|Total|All patients
11249052|NCT02544763|BG000|Baseline|GWP42003-P 25 mg/kg/Day|Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249053|NCT02544763|BG001|Baseline|GWP42003-P 50 mg/kg/Day|Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249054|NCT02544763|BG002|Baseline|Placebo|Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily [morning and evening] administration) for 16 weeks.
11249055|NCT02544763|BG003|Baseline|Total|Total of all reporting groups
11249056|NCT02544763|FG000|Participant Flow|GWP42003-P 25 mg/kg/Day|Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249057|NCT02544763|FG001|Participant Flow|GWP42003-P 50 mg/kg/Day|Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249058|NCT02544763|FG002|Participant Flow|Placebo|Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily [morning and evening] administration) for 16 weeks.
11249059|NCT02544763|OG000|Outcome|GWP42003-P 25 mg/kg/Day|Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249060|NCT02544763|OG001|Outcome|GWP42003-P 50 mg/kg/Day|Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249061|NCT02544763|OG002|Outcome|Placebo|Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily [morning and evening] administration) for 16 weeks.
11249062|NCT02544763|EG000|Reported Event|GWP42003-P 25 mg/kg/Day|Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249063|NCT02544763|EG001|Reported Event|GWP42003-P 50 mg/kg/Day|Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily [morning and evening] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.
11249064|NCT02544763|EG002|Reported Event|Placebo|Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily [morning and evening] administration) for 16 weeks.
11249065|NCT02544984|BG000|Baseline|Placebo|The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249066|NCT02544984|BG001|Baseline|Azithromycin|The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249067|NCT02544984|BG002|Baseline|Total|Total of all reporting groups
11249068|NCT02544984|FG000|Participant Flow|Placebo|The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249069|NCT02544984|FG001|Participant Flow|Azithromycin|The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249070|NCT02544984|OG000|Outcome|Placebo|The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249071|NCT02544984|OG001|Outcome|Azithromycin|The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249072|NCT02544984|EG000|Reported Event|Placebo|The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication. Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249073|NCT02544984|EG001|Reported Event|Azithromycin|The azithromycin group will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
11249074|NCT02545075|BG000|Baseline|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)
11249075|NCT02545075|BG001|Baseline|Dacarbazine (250 mg/m2)|DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
11249076|NCT02545075|BG002|Baseline|Total|Total of all reporting groups
11249077|NCT02545075|FG000|Participant Flow|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)
11249078|NCT02545075|FG001|Participant Flow|Dacarbazine (250 mg/m2)|DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
11249079|NCT02545075|OG000|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)
11249080|NCT02545075|OG001|Outcome|Dacarbazine (250 mg/m2)|DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
11249081|NCT02545075|EG000|Reported Event|Ipilimumab|Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)
11249082|NCT02545075|EG001|Reported Event|Dacarbazine|DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
11249083|NCT02545101|BG000|Baseline|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
11249084|NCT02545101|FG000|Participant Flow|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
11249085|NCT02545101|OG000|Outcome|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
11249086|NCT02545101|EG000|Reported Event|Tolvaptan|Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH.
11286371|NCT02887183|FG000|Participant Flow|LCZ696(Sacubitril/Valsartan)|"Subjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3).~Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily."
11286372|NCT02887183|OG000|Outcome|LCZ696(Sacubitril/Valsartan)|"Subjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3).~Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily."
10820295|NCT00056407|EG000|Reported Event|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
11249087|NCT02545270|BG000|Baseline|Group 1: 12-9-6 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation."
11249088|NCT02545270|BG001|Baseline|Group 2: 11-8-5 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation."
11249089|NCT02545270|BG002|Baseline|Group 3: 10-7-4 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation."
11249090|NCT02545270|BG003|Baseline|Total|Total of all reporting groups
11249091|NCT02545270|FG000|Participant Flow|Group 1: 12-9-6 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation."
11249092|NCT02545270|FG001|Participant Flow|Group 2: 11-8-5 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation."
11249093|NCT02545270|FG002|Participant Flow|Group 3: 10-7-4 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation."
11249094|NCT02545270|OG000|Outcome|Surgeons Assessing Video Sequences|7 experienced surgeons recruited: Specialist level of training Performed >200 laparoscopic cholecystectomies
11249095|NCT02545270|OG000|Outcome|Strength of the Relationship Between the Two Scales|A regression analysis using Spearman's correlation coefficient was calculated to assess the strength of the relationship between the two scales.
11249096|NCT02545270|OG000|Outcome|Surgeons Assessing Video Sequences 5-point Scale|7 experienced surgeons recruited: Specialist level of training Performed >200 laparoscopic cholecystectomies
11249097|NCT02545270|OG001|Outcome|Surgeons Assessing Video Sequences 10-point Scale|7 experienced surgeons recruited: Specialist level of training Performed >200 laparoscopic cholecystectomies
11249098|NCT02545270|EG000|Reported Event|Group 1: 12-9-6 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation."
11249099|NCT02545270|EG001|Reported Event|Group 2: 11-8-5 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation."
11249100|NCT02545270|EG002|Reported Event|Group 3: 10-7-4 mmHg|"Elective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation after surgery is completed.~Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation."
11249101|NCT02545322|BG000|Baseline|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
11249102|NCT02545322|FG000|Participant Flow|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
11213563|NCT02287675|OG001|Outcome|Sulfur Colloid|"Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:~In adults, to assist in the:~localization of lymph nodes draining a primary tumor in patients with~breast cancer or malignant melanoma when used with a hand-held gamma counter.~evaluation of peritoneovenous (LeVeen) shunt patency in adults."
10820296|NCT00056407|EG001|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
10820297|NCT00056472|BG000|Baseline|Pharmacotherapy|sertraline plus olanzapine
11213564|NCT02287675|EG000|Reported Event|Lymphoseek|Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
11213565|NCT02287675|EG001|Reported Event|Sulfur Colloid|"Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:~In adults, to assist in the:~localization of lymph nodes draining a primary tumor in patients with~breast cancer or malignant melanoma when used with a hand-held gamma counter.~evaluation of peritoneovenous (LeVeen) shunt patency in adults."
11213566|NCT02287688|BG000|Baseline|Exposure Group|Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
11213567|NCT02287688|FG000|Participant Flow|Exposure Group|Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
11213568|NCT02287688|OG000|Outcome|Exposure Group|Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
11213569|NCT02287688|EG000|Reported Event|Exposure Group|Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
11213570|NCT02287779|BG000|Baseline|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
11213571|NCT02287779|BG001|Baseline|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
11213572|NCT02287779|BG002|Baseline|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
11213573|NCT02287779|BG003|Baseline|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
11213574|NCT02287779|BG004|Baseline|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
11213575|NCT02287779|BG005|Baseline|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
11213576|NCT02287779|BG006|Baseline|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
11213577|NCT02287779|BG007|Baseline|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
11213578|NCT02287779|BG008|Baseline|Total|Total of all reporting groups
11213579|NCT02287779|FG000|Participant Flow|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
11213580|NCT02287779|FG001|Participant Flow|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
11213581|NCT02287779|FG002|Participant Flow|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
11213582|NCT02287779|FG003|Participant Flow|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
11213583|NCT02287779|FG004|Participant Flow|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
11213584|NCT02287779|FG005|Participant Flow|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
11213585|NCT02287779|FG006|Participant Flow|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
11213586|NCT02287779|FG007|Participant Flow|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
11213587|NCT02287779|OG000|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
11213588|NCT02287779|OG001|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
11213589|NCT02287779|OG002|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
11213590|NCT02287779|OG003|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
11213591|NCT02287779|OG004|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
11213592|NCT02287779|OG005|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
11213593|NCT02287779|OG006|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
11213594|NCT02287779|OG007|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
11213595|NCT02287779|OG001|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
11213596|NCT02287779|OG002|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
11213597|NCT02287779|OG002|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
11213598|NCT02287779|OG000|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
11249103|NCT02545322|OG000|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
11249104|NCT02545322|EG000|Reported Event|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
11249105|NCT02545504|BG000|Baseline|Andecaliximab + mFOLFOX6|Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.
11249106|NCT02545504|BG001|Baseline|Placebo + mFOLFOX6|Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.
11249107|NCT02545504|BG002|Baseline|Total|Total of all reporting groups
11249108|NCT02545504|FG000|Participant Flow|Andecaliximab + mFOLFOX6|Participants were randomized to receive andecaliximab 800 mg intravenous (IV) plus mFOLFOX6 [leucovorin (LV)+5-fluorouracil (5-FU) + oxaliplatin (OXA)] IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.
11249109|NCT02545504|FG001|Participant Flow|Placebo + mFOLFOX6|Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.
11249110|NCT02545504|OG000|Outcome|Andecaliximab + mFOLFOX6|Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 135.4 weeks at the time of final analysis.
11249111|NCT02545504|OG001|Outcome|Placebo + mFOLFOX6|Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 99.7 weeks at the time of final analysis.
11249112|NCT02545504|OG000|Outcome|Andecaliximab + mFOLFOX6|Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 135.4 weeks at the time of the final analysis.
11249113|NCT02545504|OG001|Outcome|Placebo + mFOLFOX6|Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 99.7 weeks at the time of the final analysis.
11249114|NCT02545504|OG000|Outcome|Andecaliximab + mFOLFOX6|Participants received andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.
10969707|NCT00907257|OG001|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
10969708|NCT00907257|EG000|Reported Event|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
10969709|NCT00907257|EG001|Reported Event|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
10969710|NCT00907296|BG000|Baseline|Placebo|Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
11249115|NCT02545504|OG001|Outcome|Placebo + mFOLFOX6|Participants received placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.
11249116|NCT02545504|EG000|Reported Event|Andecaliximab + mFOLFOX6|Participants received andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.
11249117|NCT02545504|EG001|Reported Event|Placebo + mFOLFOX6|Participants received placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.
11249118|NCT02545543|BG000|Baseline|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249119|NCT02545543|BG001|Baseline|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249120|NCT02545543|BG002|Baseline|Total|Total of all reporting groups
11249121|NCT02545543|FG000|Participant Flow|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249122|NCT02545543|FG001|Participant Flow|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249123|NCT02545543|OG000|Outcome|GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV|GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
11249124|NCT02545543|OG000|Outcome|SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR %|Seroconversion rate difference = Comparator QIV SCR percentage minus Seqirus QIV SCR percentage
11249125|NCT02545543|OG000|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249126|NCT02545543|OG001|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249127|NCT02545543|EG000|Reported Event|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249128|NCT02545543|EG001|Reported Event|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
11249129|NCT02545608|BG000|Baseline|Restylane Vital in Both Hands|
11249130|NCT02545608|BG001|Baseline|Restylane Vital in Randomized Hand, no Treatment in the Other|
10969711|NCT00907296|BG001|Baseline|Romosozumab 70 mg: 2 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10820298|NCT00056472|BG001|Baseline|Monotherapy|placebo plus olanzapine
10969712|NCT00907296|BG002|Baseline|Romosozumab 70 mg: 3 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
11249131|NCT02545608|BG002|Baseline|Total|Total of all reporting groups
11249132|NCT02545608|FG000|Participant Flow|Restylane Vital in Both Hands|
11249133|NCT02545608|FG001|Participant Flow|Restylane Vital in Randomized Hand, no Treatment in the Other|
11249134|NCT02545608|OG000|Outcome|Restylane Vital in Randomized Hand|Restylane Vital in randomized hand
11249135|NCT02545608|OG001|Outcome|No-treatment Control Hand|No treatment control hand
11249136|NCT02545608|EG000|Reported Event|Restylane Vital in Both Hands|Restylane Vital in both hands
11249137|NCT02545608|EG001|Reported Event|Restylane Vital in Randomized Hand|Restylane Vital in randomized hand
11249138|NCT02545608|EG002|Reported Event|No-treatment Control Hand|No treatment control hand
11249139|NCT02545907|BG000|Baseline|Dose Level 0 - 26/mg^2|Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m^2 administered on Day 1, 8, and 15,.
11249140|NCT02545907|BG001|Baseline|Dose Level 1 - 45/mg^2|Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m^2 administered on Day 1, 8, and 15,.
11249141|NCT02545907|BG002|Baseline|Total|Total of all reporting groups
11249142|NCT02545907|FG000|Participant Flow|Period 1- Dose Level 0 - 36mg/m^2|3 evaluable participants were recruited to dose level 0.
11249143|NCT02545907|FG001|Participant Flow|Period 2 - Dose Level 1 - 45mg/m^2|3 evaluable participants were recruited to dose level 1, one of which experienced a dose limiting toxicity.
11249144|NCT02545907|FG002|Participant Flow|Period 3 - Dose Level 1 - 45mg/m^2|4 participants were recruited to dose level 1; three of which were evaluable for the maximum tolerated dose, one of which was deemed unevaluable due experiencing an SAE after the loading dose (20 mg/m^2) of carfilzomib and was replaced.
11249145|NCT02545907|OG000|Outcome|Dose Level 0|Participants who were allocated to receive dose level 0 and received at least one cycle of the study treatment. KTD Patients who do not receive one complete cycle due to experiencing a DLT will be included in the analysis; patients who do not receive at least one complete cycle for reasons other than toxicity, without experiencing a DLT, and who miss a dose of Carfilzomib, more than 14 doses Thalidomide or 2 doses of Dexamethasone in the first cycle, will be replaced.
11249146|NCT02545907|OG001|Outcome|Dose Level 1|Participants who were allocated to receive dose level 1 and received at least one cycle of the study treatment. KTD Patients who do not receive one complete cycle due to experiencing a DLT will be included in the analysis; patients who do not receive at least one complete cycle for reasons other than toxicity, without experiencing a DLT, and who miss a dose of Carfilzomib, more than 14 doses Thalidomide or 2 doses of Dexamethasone in the first cycle, will be replaced.
11249147|NCT02545907|OG000|Outcome|Dose Level 0- Safety Population|All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
11249148|NCT02545907|OG001|Outcome|Dose Level 1- Safety Population|All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
11249149|NCT02545907|OG000|Outcome|Safety Population|All patients that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set..
11249150|NCT02545907|EG000|Reported Event|Dose Level 0 - Safety Population|All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
11249151|NCT02545907|EG001|Reported Event|Dose Level 1 - Safety Population|All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
11249152|NCT02545933|BG000|Baseline|DAPT Plus Vorapaxar|"Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249153|NCT02545933|BG001|Baseline|Prasugrel/Ticagrelor Plus Vorapaxar|"Prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249154|NCT02545933|BG002|Baseline|DAPT|"Aspirin in addition to prasugrel or ticagrelor~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249155|NCT02545933|BG003|Baseline|Total|Total of all reporting groups
11249156|NCT02545933|FG000|Participant Flow|DAPT Plus Vorapaxar|"Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249157|NCT02545933|FG001|Participant Flow|Prasugrel/Ticagrelor Plus Vorapaxar|"Prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249158|NCT02545933|FG002|Participant Flow|DAPT|"Aspirin in addition to prasugrel or ticagrelor~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249159|NCT02545933|OG000|Outcome|DAPT Plus Vorapaxar|"Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249160|NCT02545933|OG001|Outcome|Prasugrel/Ticagrelor Plus Vorapaxar|"Prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249161|NCT02545933|OG002|Outcome|DAPT|"Aspirin in addition to prasugrel or ticagrelor~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249162|NCT02545933|EG000|Reported Event|DAPT Plus Vorapaxar|"Aspirin plus prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249163|NCT02545933|EG001|Reported Event|Prasugrel/Ticagrelor Plus Vorapaxar|"Prasugrel or ticagrelor plus vorapaxar 2.5mg od~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Vorapaxar: Vorapaxar will be administered at the dose of 2.5mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249164|NCT02545933|EG002|Reported Event|DAPT|"Aspirin in addition to prasugrel or ticagrelor~Prasugrel: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)~Aspirin: Aspirin will be administered at the dose of 81mg once daily~Ticagrelor: Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)"
11249165|NCT02546193|BG000|Baseline|Outpatient Foley Catheter (Randomized & Prospective)|"This arm reflects enrolled women who were (A) randomized to the outpatient Foley catheter group (RCT design) or (B) chose the outpatient Foley catheter group (Modified Prospective study design). NOTE: Baseline data were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure.~Participants underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting."
11249166|NCT02546193|BG001|Baseline|Inpatient Usual Care (Randomized & Prospective)|"This arm reflects enrolled women who were (A) randomized to the inpatient usual care group (RCT design) or (B) chose the inpatient usual care group (Modified Prospective study design). NOTE: Baseline data were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure.~Participants presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course."
11249167|NCT02546193|BG002|Baseline|Total|Total of all reporting groups
11249168|NCT02546193|FG000|Participant Flow|Outpatient Foley Catheter|Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.
11249169|NCT02546193|FG001|Participant Flow|Inpatient Usual Care|Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They will remained in the inpatient setting throughout their entire labor induction course.
11249170|NCT02546193|FG002|Participant Flow|Prospective Study Outpatient Intervention Group|Women chose the outpatient Foley catheter group underwent basic history review, fetal non-stress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.
10820299|NCT00056472|BG002|Baseline|Total|Total of all reporting groups
10820300|NCT00056472|FG000|Participant Flow|Sertraline Plus Olanzapine|50-200mg/day sertraline plus 5-20mg/day olanzapine
11249171|NCT02546193|FG003|Participant Flow|Prospective Study Inpatient Usual Care Group|Women who chose the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal non-stress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They will remained in the inpatient setting throughout their entire labor induction course.
11249172|NCT02546193|OG000|Outcome|Outpatient Foley Catheter|Women randomized to the outpatient Foley catheter group underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.
11249173|NCT02546193|OG001|Outcome|Inpatient Usual Care|Women randomized to the inpatient usual care group presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.
11249174|NCT02546193|EG000|Reported Event|Outpatient Foley Catheter (Randomized & Prospective)|"This arm reflects enrolled women who were (A) randomized to the outpatient Foley catheter group (RCT design) or (B) chose the outpatient Foley catheter group (Modified Prospective study design). NOTE: Adverse events were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure.~Participants underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting."
11249175|NCT02546193|EG001|Reported Event|Inpatient Usual Care (Randomized & Prospective)|"This arm reflects enrolled women who were (A) randomized to the inpatient usual care group (RCT design) or (B) chose the inpatient usual care group (Modified Prospective study design). NOTE: Adverse events were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure.~Participants presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course."
11249176|NCT02546323|BG000|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249177|NCT02546323|BG001|Baseline|Placebo|Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249178|NCT02546323|BG002|Baseline|Total|Total of all reporting groups
11249179|NCT02546323|FG000|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249180|NCT02546323|FG001|Participant Flow|Placebo|Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249181|NCT02546323|OG000|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249182|NCT02546323|OG001|Outcome|Placebo|Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249183|NCT02546323|EG000|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249184|NCT02546323|EG001|Reported Event|Placebo|Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
11249185|NCT02546362|BG000|Baseline|Cefaly Active Device|12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
11249186|NCT02546362|FG000|Participant Flow|Cefaly Active Device|12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes
11249187|NCT02546362|OG000|Outcome|Cefaly Active Device|12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
11249188|NCT02546362|EG000|Reported Event|Active|12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
11249189|NCT02546375|BG000|Baseline|Bosutinib|Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC.
11249190|NCT02546375|FG000|Participant Flow|Bosutinib|Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 milligram (mg), were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved Summary of Product Characteristics (SmPC).
11249191|NCT02546375|OG000|Outcome|Bosutinib|Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC.
10820301|NCT00056472|FG001|Participant Flow|Olanzapine Plus Placebo|5-20mg/day olanzapine plus placebo
10820302|NCT00056472|OG000|Outcome|Pharmacotherapy|sertraline plus olanzapine
10820303|NCT00056472|OG001|Outcome|Monotherapy|placebo plus olanzapine
11249192|NCT02546375|EG000|Reported Event|Bosutinib|Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC.
11249193|NCT02546388|BG000|Baseline|Indium-111 Pentreotide (OctreoScan)|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
11249194|NCT02546388|BG001|Baseline|Gallium-68 DOTATATE|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
11249195|NCT02546388|BG002|Baseline|Total|Total of all reporting groups
11249196|NCT02546388|FG000|Participant Flow|Indium-111 Pentreotide (OctreoScan)|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
11249197|NCT02546388|FG001|Participant Flow|Gallium-68 DOTATATE|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
11249198|NCT02546388|OG000|Outcome|Gallium-68 DOTATATE|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
11249199|NCT02546388|OG001|Outcome|Indium-111 Pentreotide (OctreoScan)|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
11249200|NCT02546388|OG000|Outcome|Participants With a Positive or Negative Response to Treatment|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan) or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
11249201|NCT02546388|EG000|Reported Event|Indium-111 Pentreotide (OctreoScan)|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
11249202|NCT02546388|EG001|Reported Event|Gallium-68 DOTATATE|Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
11249203|NCT02546544|BG000|Baseline|Linsitinib|Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg
11249204|NCT02546544|FG000|Participant Flow|Linsitinib|Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg
11249205|NCT02546544|OG000|Outcome|Linsitinib|Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg
11249206|NCT02546544|EG000|Reported Event|Linsitinib|Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg
11249207|NCT02546570|BG000|Baseline|Adults With PTSD (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249208|NCT02546570|BG001|Baseline|Trauma-exposed/No-PTSD Adults (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249209|NCT02546570|BG002|Baseline|Total|Total of all reporting groups
11249210|NCT02546570|FG000|Participant Flow|Adults With PTSD (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure. Placebo: See arm/group descriptions for dosage amount and procedure."
11249211|NCT02546570|FG001|Participant Flow|Trauma-exposed/No-PTSD Adults (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure. Placebo: See arm/group descriptions for dosage amount and procedure."
11249212|NCT02546570|OG000|Outcome|Adults With PTSD (18-55): Drug|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249213|NCT02546570|OG001|Outcome|Adults With PTSD (18-55): Placebo|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249214|NCT02546570|OG002|Outcome|Adults Without PTSD (18-55): Drug|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249215|NCT02546570|OG003|Outcome|Adults Without PTSD (18-55): Placebo|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249216|NCT02546570|OG000|Outcome|Adults With and Without PTSD (18-55): Drug|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249217|NCT02546570|OG001|Outcome|Adults With and Without PTSD (18-55): Placebo|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249218|NCT02546570|EG000|Reported Event|Adults With PTSD (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249219|NCT02546570|EG001|Reported Event|Trauma-exposed/No-PTSD Adults (18-55)|"Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).~Oxytocin: See arm/group descriptions for dosage amount and procedure.~Placebo: See arm/group descriptions for dosage amount and procedure."
11249220|NCT02546609|BG000|Baseline|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
11249221|NCT02546609|BG001|Baseline|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
11249222|NCT02546609|BG002|Baseline|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
11249223|NCT02546609|BG003|Baseline|Total|Total of all reporting groups
11249224|NCT02546609|FG000|Participant Flow|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
11249225|NCT02546609|FG001|Participant Flow|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
11249226|NCT02546609|FG002|Participant Flow|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
11249227|NCT02546609|OG000|Outcome|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
11249228|NCT02546609|OG001|Outcome|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
11249229|NCT02546609|OG002|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
11249230|NCT02546609|EG000|Reported Event|Placebo|"3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)~Placebo: Placebo"
11249231|NCT02546609|EG001|Reported Event|Leu Met Sil 0.5mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil.~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID~Sildenafil Citrate 0.5 mg: Sildenafil 0.5 mg BID"
11249232|NCT02546609|EG002|Reported Event|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil.~Sildenafil 1.0 mg: Sildenafil 1.0 mg~Metformin: 500 mg Metformin BID~Leucine: 1100 mg Leucine BID"
11249233|NCT02546765|BG000|Baseline|Acetaminophen-Propofol|Received Intravenous Acetaminophen 6 hourly for 8 doses and intravenous Propofol as sedative until extubation
11249234|NCT02546765|BG001|Baseline|Acetaminophen-Dexmedetomidine|Received Intravenous Acetaminophen 6 hourly for 8 doses and intravenous dexmedetomidine as sedative until extubation
11249235|NCT02546765|BG002|Baseline|Placebo-Propofol|Received Intravenous Placebo 6 hourly for 8 doses and Intravenous Propofol as a sedative until extubation
11249236|NCT02546765|BG003|Baseline|Placebo-Dexmedetomidine|Received Intravenous Placebo 6 hourly for 8 doses and Intravenous Dexmedetomidine as a sedative until extubation
11249237|NCT02546765|BG004|Baseline|Total|Total of all reporting groups
11249238|NCT02546765|FG000|Participant Flow|IV Acetaminophen & IV Propofol|"20-100 µg/kg/min IV propofol given for 4-6 hours before the patients are woken up in the ICU~1g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively~IV acetaminophen & IV propofol: use of IV tylenol and IV propofol for pain and sedation (respectively)"
11249239|NCT02546765|FG001|Participant Flow|IV Acetaminophen & IV Dexmedetomidine|"A loading infusion of 0.5 - 1 µg/kg given over 10 minutes will be administered. After the loading infusion, a maintenance infusion of 0.1-1.4 µg/kg/hr will be initiated.~1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively~IV acetaminophen & IV dexmedetomidine: use of IV tylenol and IV dexmedetomidine for pain and sedation (respectively)"
11249240|NCT02546765|FG002|Participant Flow|IV Propofol & Placebo|"20-100 µg/kg/min IV propofol given for 4-6 hours before the patients are woken up in the ICU Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl.~IV propofol & placebo: use of IV propofol for sedation and morphine, the drug of choice for cardiac pain"
11249241|NCT02546765|FG003|Participant Flow|IV Dexmedetomidine & Placebo|"0.1-1.0 µg/kg/hour IV dexmedetomidine given for 4-6 hours before the patients are woken up in the ICU Volume of the placebo (saline) will match that of i.v. acetaminophen at 100ml 0.9% NaCl.~IV dexmedetomidine & placebo: use of IV dexmedetomidine for sedation and morphine, the drug of choice for cardiac pain"
11249242|NCT02546765|OG000|Outcome|Acetaminophen and Dexmedetomidine|Patients who received intravenous Acetaminophen for analgesia and dexmedetomidine for sedation
11249243|NCT02546765|OG001|Outcome|Acetaminophen and Propofol|Those who received IV acetaminophen for analgesia and Propofol for sedation
11249244|NCT02546765|OG002|Outcome|Placebo and Dexmedetomidine|Those who received Placebo for analgesia and dexmedetomidine for sedation
11249245|NCT02546765|OG003|Outcome|Placebo and Propofol|Patients who received placebo for analgesia and Propofol for sedation
11249246|NCT02546765|OG000|Outcome|Acetaminophen and Dexmedetomidine|Those who received Acetaminophen for analgesia and dexmedetomidine for sedation
11249247|NCT02546765|OG001|Outcome|Acetaminophen and Propofol|Those who received acetaminophen for analgesia and propofol for sedation
11249248|NCT02546765|OG002|Outcome|Placebo and Dexmedetomidine|Those who received placebo for analgesia and dexmedetomidine for sedation
11249249|NCT02546765|OG003|Outcome|Placebo and Propofol|Those who received Placebo for sedation and Propofol for analgesia
11249250|NCT02546765|OG000|Outcome|Acetaminophen and Dexmedetomidine|Those who received acetaminophen for analgesia and dexmedetomidine for sedation
11249251|NCT02546765|OG003|Outcome|Placebo and Propofol|Those who received placebo for analgesia and propofol for sedation
11249252|NCT02546765|OG003|Outcome|Placebo and Propofol|Those who received placebo for analgesia and dexmedetomidine for sedation
11249253|NCT02546765|OG001|Outcome|Acetaminophen and Propofol|Those who received placebo for analgesia and propofol for sedation
11249254|NCT02546765|OG003|Outcome|Placebo and Propofol|Those who received Placebo for analgesia and Propofol for sedation
10820304|NCT00056472|EG000|Reported Event|Pharmacotherapy|sertraline plus olanzapine
10820305|NCT00056472|EG001|Reported Event|Monotherapy|placebo plus olanzapine
10820306|NCT00056498|BG000|Baseline|Risperidone|Participants assigned to risperidone
10820307|NCT00056498|BG001|Baseline|Placebo|Participants assigned to placebo
11249255|NCT02546765|OG000|Outcome|Acetaminophen and Dexmedetomidine|Patients who received intravenous Acetaminophen for analgesia and Dexmedetomidine for sedation
11249256|NCT02546765|OG002|Outcome|Placebo and Dexmedetomidine|Those who received Placebo for analgesia and Dexmedetomidine for sedation
11249257|NCT02546765|EG000|Reported Event|Acetaminophen-Propofol|Received Intravenous Acetaminophen 6 hourly for 8 doses and intravenous Propofol as sedative until extubation
11249258|NCT02546765|EG001|Reported Event|Acetaminophen-Dexmedetomidine|Received Intravenous Acetaminophen 6 hourly for 8 doses and intravenous dexmedetomidine as sedative until extubation
11249259|NCT02546765|EG002|Reported Event|Placebo-Propofol|Received Intravenous Placebo 6 hourly for 8 doses and Intravenous Propofol as a sedative until extubation
11249260|NCT02546765|EG003|Reported Event|Placebo-Dexmedetomidine|Received Intravenous Placebo 6 hourly for 8 doses and Intravenous Dexmedetomidine as a sedative until extubation
11249261|NCT02546856|BG000|Baseline|Heart Failure (HF) Cardiologist Up-titration|"Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.~HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo Left Ventricular Ejection Fraction≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines"
11249262|NCT02546856|BG001|Baseline|HF Nurse Up-titration|"Patients, following a protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo Left Ventricular Ejection Fraction ≤ 40% Patients, . Protocol based on 2012 ESC HF guidelines."
11249263|NCT02546856|BG002|Baseline|Total|Total of all reporting groups
11249264|NCT02546856|FG000|Participant Flow|Heart Failure (HF) Nurse Up-titration|"Intervention:The cardiologist prescribes drugs and the HF-nurse implements the up-titration, driven by protocol based on 2012 ESC HF guidelines, with cardiologist support.~Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients"
11249265|NCT02546856|FG001|Participant Flow|Heart Failure (HF) Cardiologist Up-titration|"Active Comparator:The cardiologist prescribes and decides dosage following a protocol based on 2012 ESC HF guidelines, with nursing clinical and educational support.~Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure De Novo Left Ventricular Ejection Fraction ≤ 40% Patients"
11249266|NCT02546856|OG000|Outcome|Heart Failure (HF) Cardiologist Up-titration|"Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.~HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines"
11249267|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines."
11249268|NCT02546856|OG000|Outcome|Heart Failure (HF) Cardiologist Up-titration|"Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.~HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines"
11249269|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines."
11249270|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11286373|NCT02887183|EG000|Reported Event|LCZ696 (Sacubitril/Valsartan)|"Subjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3).~Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily"
10820308|NCT00056498|BG002|Baseline|Total|Total of all reporting groups
11249271|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249272|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines with cardiologist prescription and support.~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249273|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients,. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249274|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines.~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients,. Protocol based on 2012 ESC HF guidelines."
11249275|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% Patient. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249276|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249277|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients,. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11286374|NCT02887404|BG000|Baseline|Spine Surgery Analgesic Pathway|"Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Spine surgery analgesic pathway: Enhanced pain management care"
11249278|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249279|NCT02546856|OG001|Outcome|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines with cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249280|NCT02546856|EG000|Reported Event|Heart Failure (HF) Cardiologist Up-titration|"Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.~HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines~HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines"
11249281|NCT02546856|EG001|Reported Event|HF Nurse Up-titration|"Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.~HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support~HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure  De Novo EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support"
11249282|NCT02547012|BG000|Baseline|Esomeprazole+Amox+Levo+Tetra|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.~esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s."
11249283|NCT02547012|BG001|Baseline|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,"
11249284|NCT02547012|BG002|Baseline|Total|Total of all reporting groups
11249285|NCT02547012|FG000|Participant Flow|Esomeprazole+Amox+Levo+Tetra|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.~esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s."
11249286|NCT02547012|FG001|Participant Flow|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,"
11249287|NCT02547012|OG000|Outcome|Esomeprazole+Amox+Levo+Tetra|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.~esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s."
11249288|NCT02547012|OG001|Outcome|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,"
11249289|NCT02547012|EG000|Reported Event|Esomeprazole+Amox+Levo+Tetra|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.~esomeprazole+amox+levo+tetra: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s."
11249290|NCT02547012|EG001|Reported Event|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,"
11249291|NCT02547038|BG000|Baseline|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days"
11249292|NCT02547038|BG001|Baseline|(Panto+Amox+Clar+Metr)+(Panto+Amox)|"a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily~(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily"
11249293|NCT02547038|BG002|Baseline|Total|Total of all reporting groups
11249294|NCT02547038|FG000|Participant Flow|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days"
11249295|NCT02547038|FG001|Participant Flow|(Panto+Amox+Clar+Metr)+(Panto+Amox)|"a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily~(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily"
11249296|NCT02547038|OG000|Outcome|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days"
11249297|NCT02547038|OG001|Outcome|(Panto+Amox+Clar+Metr)+(Panto+Amox)|"a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily~(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily"
11249298|NCT02547038|EG000|Reported Event|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days~pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days"
11249299|NCT02547038|EG001|Reported Event|(Panto+Amox+Clar+Metr)+(Panto+Amox)|"a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily~(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily"
11249300|NCT02547064|BG000|Baseline|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
11249301|NCT02547064|BG001|Baseline|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
11249302|NCT02547064|BG002|Baseline|Total|Total of all reporting groups
10969713|NCT00907296|BG003|Baseline|Romosozumab 70 mg: 4 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249303|NCT02547064|FG000|Participant Flow|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
11249304|NCT02547064|FG001|Participant Flow|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
11249305|NCT02547064|OG000|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
11249306|NCT02547064|OG001|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
11249307|NCT02547064|EG000|Reported Event|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
11249308|NCT02547064|EG001|Reported Event|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
11249309|NCT02547220|BG000|Baseline|Placebo|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of placebo (100 mL 0.9% sodium chloride) on day 1 followed by 2500 units of placebo (100 mL 0.9% sodium chloride) on Days 3, 5, 7, 9, 11, and 13.
11249310|NCT02547220|BG001|Baseline|CINRYZE|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of CINRYZE on Day 1 followed by 2500 units of CINRYZE in 100 mL of IV infusion on Day 3, 5, 7, 9, 11, and 13.
11249311|NCT02547220|BG002|Baseline|Total|Total of all reporting groups
11249312|NCT02547220|FG000|Participant Flow|Placebo|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of placebo (100 mL 0.9 percent [%] sodium chloride) on day 1 followed by 2500 units of placebo (100 mL 0.9% sodium chloride) on Days 3, 5, 7, 9, 11, and 13.
11249313|NCT02547220|FG001|Participant Flow|CINRYZE|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of CINRYZE on Day 1 followed by 2500 units of CINRYZE in 100 mL of IV infusion on Day 3, 5, 7, 9, 11, and 13.
10820309|NCT00056498|FG000|Participant Flow|Risperidone|Participants assigned to risperidone
10969714|NCT00907296|BG004|Baseline|Romosozumab 140 mg: 2 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969715|NCT00907296|BG005|Baseline|Romosozumab 140 mg: 3 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
11249314|NCT02547220|OG000|Outcome|Placebo|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of placebo (100 mL 0.9% sodium chloride) on day 1 followed by 2500 units of placebo (100 mL 0.9% sodium chloride) on Days 3, 5, 7, 9, 11, and 13.
11249315|NCT02547220|OG001|Outcome|CINRYZE|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of CINRYZE on Day 1 followed by 2500 units of CINRYZE in 100 mL of IV infusion on Day 3, 5, 7, 9, 11, and 13.
11249316|NCT02547220|EG000|Reported Event|Placebo|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of placebo (100 mL 0.9% sodium chloride) on day 1 followed by 2500 units of placebo (100 mL 0.9% sodium chloride) on Days 3, 5, 7, 9, 11, and 13.
11249317|NCT02547220|EG001|Reported Event|CINRYZE|Participants received a total of seven doses with an initial 100 mL intravenous (IV) infusion containing 5000 units of CINRYZE on Day 1 followed by 2500 units of CINRYZE in 100 mL of IV infusion on Day 3, 5, 7, 9, 11, and 13.
11249318|NCT02547233|BG000|Baseline|LEO 43204 0.018% Gel|Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel
11249319|NCT02547233|BG001|Baseline|Vehicle Gel|Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
11249320|NCT02547233|BG002|Baseline|Total|Total of all reporting groups
11249321|NCT02547233|FG000|Participant Flow|LEO 43204 0.018% Gel|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
11249322|NCT02547233|FG001|Participant Flow|Vehicle Gel|Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
11249323|NCT02547233|OG000|Outcome|LEO 43204 0.018% Gel|Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel
11249324|NCT02547233|OG001|Outcome|Vehicle Gel|Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
10969716|NCT00907296|BG006|Baseline|Romosozumab 140 mg: 4 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249325|NCT02547233|EG000|Reported Event|LEO 43204 0.018% Gel - Treatment Period Including Follow-up|Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel
10820310|NCT00056498|FG001|Participant Flow|Placebo|Participants assigned to placebo
10820311|NCT00056498|OG000|Outcome|Risperidone|Participants assigned to risperidone
10969717|NCT00907296|BG007|Baseline|Romosozumab 210 mg: 2 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
11249326|NCT02547233|EG001|Reported Event|Vehicle Gel - Treatment Period Including Follow-up|Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
11249327|NCT02547233|EG002|Reported Event|LEO 43204 0.018% Gel - Extended Follow-up|Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel
11249328|NCT02547233|EG003|Reported Event|Vehicle Gel - Extended Follow-up|Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
11249329|NCT02547363|BG000|Baseline|LEO 43204 0.037% Gel|Treatment once daily for 3 days with LEO 43204 0.037% gel
11249330|NCT02547363|BG001|Baseline|Vehicle Gel|Treatment once daily for 3 days with vehicle gel
11249331|NCT02547363|BG002|Baseline|Total|Total of all reporting groups
11249332|NCT02547363|FG000|Participant Flow|LEO 43204 0.037% Gel|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249333|NCT02547363|FG001|Participant Flow|Vehicle Gel|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249334|NCT02547363|OG000|Outcome|LEO 43204 0.037% Gel|Treatment once daily for 3 days with LEO 43204 0.037% gel
11249335|NCT02547363|OG001|Outcome|Vehicle Gel|Treatment once daily for 3 days with vehicle gel
11249336|NCT02547363|EG000|Reported Event|LEO 43204 0.037% Gel|Treatment once daily for 3 days with LEO 43204 0.037% gel
11249337|NCT02547363|EG001|Reported Event|Vehicle Gel|Treatment once daily for 3 days with vehicle gel
11249338|NCT02547363|EG002|Reported Event|LEO 43204 0.037% Gel - Extended Follow-up|Treatment once daily for 3 days with LEO 43204 0.037% gel
11249339|NCT02547363|EG003|Reported Event|Vehicle Gel - Extended Follow-up|Treatment once daily for 3 days with vehicle gel
11249340|NCT02547428|BG000|Baseline|CTN SR First, Then Placebo|Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common TDD was 400 mg/day.
11249341|NCT02547428|BG001|Baseline|Placebo First, Then CTN SR|Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.
11249342|NCT02547428|BG002|Baseline|Total|Total of all reporting groups
11249343|NCT02547428|FG000|Participant Flow|CTN SR First, Then Placebo|Participants received CTN SR tablets starting at a dose of 100 or 200 milligrams (mg) on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common total daily dose (TDD) was 400 mg/day.
11249344|NCT02547428|FG001|Participant Flow|Placebo First, Then CTN SR|Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.
11249345|NCT02547428|OG000|Outcome|CTN SR|Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day.
11249346|NCT02547428|OG001|Outcome|Placebo|Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.
11249347|NCT02547428|OG000|Outcome|CTN SR 400 mg|Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.
11249348|NCT02547428|OG001|Outcome|Placebo|Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.
11249349|NCT02547428|OG000|Outcome|CTN SR First, Then Placebo|Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common TDD was 400 mg/day.
11249350|NCT02547428|OG001|Outcome|Placebo First, Then CTN SR|Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.
11249351|NCT02547428|OG000|Outcome|CTN SR 300 mg|Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.
11249352|NCT02547428|OG001|Outcome|CTN SR 400 mg|Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.
11249353|NCT02547428|OG002|Outcome|CTN SR 600 mg|Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.
11249354|NCT02547428|EG000|Reported Event|CTN SR|Participants received CTN SR tablets at a starting dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.
11249355|NCT02547428|EG001|Reported Event|Placebo|Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.
11249356|NCT02547454|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
11249357|NCT02547454|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
11249358|NCT02547454|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
11249359|NCT02547454|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
11249360|NCT02547623|BG000|Baseline|Dexamethasone Depot|A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
11249361|NCT02547623|BG001|Baseline|Prednisolone Drops 1% (Standard of Care)|Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
11249362|NCT02547623|BG002|Baseline|Total|Total of all reporting groups
11249363|NCT02547623|FG000|Participant Flow|Dexamethasone Depot|A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
11249364|NCT02547623|FG001|Participant Flow|Prednisolone Drops 1% (Standard of Care)|Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
11249365|NCT02547623|OG000|Outcome|Dexamethasone Depot|A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
11249366|NCT02547623|OG001|Outcome|Prednisolone Drops 1% (Standard of Care)|Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
11249367|NCT02547623|EG000|Reported Event|Dexamethasone Depot|A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
11249368|NCT02547623|EG001|Reported Event|Prednisolone Drops 1% (Standard of Care)|Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
11249369|NCT02547649|BG000|Baseline|V114-A|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
11249370|NCT02547649|BG001|Baseline|V114-B|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
11249371|NCT02547649|BG002|Baseline|Prevnar 13®|Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11249372|NCT02547649|BG003|Baseline|Total|Total of all reporting groups
10820312|NCT00056498|OG001|Outcome|Placebo|Participants assigned to placebo
11249373|NCT02547649|FG000|Participant Flow|V114-A|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
11249374|NCT02547649|FG001|Participant Flow|V114-B|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
11249375|NCT02547649|FG002|Participant Flow|Prevnar 13®|Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11249376|NCT02547649|OG000|Outcome|V114-A|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
11249377|NCT02547649|OG001|Outcome|V114-B|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
11249378|NCT02547649|OG002|Outcome|Prevnar 13®|Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11249379|NCT02547649|EG000|Reported Event|V114-A|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
11249380|NCT02547649|EG001|Reported Event|V114-B|Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
11249381|NCT02547649|EG002|Reported Event|Prevnar 13®|Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11249382|NCT02547714|BG000|Baseline|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
11249383|NCT02547714|FG000|Participant Flow|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
11249384|NCT02547714|OG000|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
11249385|NCT02547714|EG000|Reported Event|Entire Period - Secukinumab (AIN457)|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
11249386|NCT02547714|EG001|Reported Event|Induction Period - Secukinumab (AIN457)|During the induction period, participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, and 4.
11249387|NCT02547766|BG000|Baseline|Anakinra Arm|"All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect.~Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days."
11249388|NCT02547766|FG000|Participant Flow|Anakinra Arm|"All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect.~Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days."
11249389|NCT02547766|OG000|Outcome|Anakinra Arm|"All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect.~Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days."
11249390|NCT02547766|EG000|Reported Event|Anakinra Arm|"All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect.~Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days."
11249391|NCT02547779|BG000|Baseline|0.9% Sodium Chloride|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11249392|NCT02547779|BG001|Baseline|Balanced Crystalloids|"Patients in an ICU block randomized to balanced crystalloids will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11249393|NCT02547779|BG002|Baseline|Total|Total of all reporting groups
11249394|NCT02547779|FG000|Participant Flow|0.9% Sodium Chloride|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11249395|NCT02547779|FG001|Participant Flow|Balanced Crystalloids|"Patients in an ICU block randomized to balanced crystalloids will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11249396|NCT02547779|OG000|Outcome|0.9% Sodium Chloride|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
10969718|NCT00907296|BG008|Baseline|Romosozumab 210 mg: 3 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969719|NCT00907296|BG009|Baseline|Romosozumab 210 mg: 4 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249397|NCT02547779|OG001|Outcome|Balanced Crystalloids|"Patients in an ICU block randomized to balanced crystalloids will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11249398|NCT02547779|EG000|Reported Event|0.9% Sodium Chloride|"Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered"
11249399|NCT02547779|EG001|Reported Event|Balanced Crystalloids|"Patients in an ICU block randomized to balanced crystalloids will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered"
11249400|NCT02547922|BG000|Baseline|Anifrolumab - Basic Regimen|Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249401|NCT02547922|BG001|Baseline|Anifrolumab - Intensified Regimen|Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249402|NCT02547922|BG002|Baseline|Placebo|Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
11249403|NCT02547922|BG003|Baseline|Total|Total of all reporting groups
11249404|NCT02547922|FG000|Participant Flow|Anifrolumab - Basic Regimen|Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249405|NCT02547922|FG001|Participant Flow|Anifrolumab - Intensified Regimen|Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249406|NCT02547922|FG002|Participant Flow|Placebo|Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
11249407|NCT02547922|OG000|Outcome|Anifrolumab - Basic Regimen|Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249408|NCT02547922|OG001|Outcome|Anifrolumab - Intensified Regimen|Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249409|NCT02547922|OG002|Outcome|All Anifrolumab|"This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.~Anifrolumab - Basic Regimen: Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.~Anifrolumab - Intensified Regimen: Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112."
11249410|NCT02547922|OG003|Outcome|Placebo|Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
11249411|NCT02547922|EG000|Reported Event|Anifrolumab - Basic Regimen- Treatment Period|Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249412|NCT02547922|EG001|Reported Event|Anifrolumab - Intensified Regimen- Treatment Period|Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249413|NCT02547922|EG002|Reported Event|All Anifrolumab- Treatment Period|"This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.~Anifrolumab - Basic Regimen: Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.~Anifrolumab - Intensified Regimen: Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112."
11249414|NCT02547922|EG003|Reported Event|Placebo- Treatment Period|Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
11249415|NCT02547922|EG004|Reported Event|Anifrolumab - Basic Regimen- Follow up|Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112
11249416|NCT02547922|EG005|Reported Event|Anifrolumab - Intensified Regimen- Follow up|Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.
11249417|NCT02547922|EG006|Reported Event|All Anifrolumab- Follow up|"This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.~Anifrolumab - Basic Regimen: Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112.~Anifrolumab - Intensified Regimen: Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112."
11249418|NCT02547922|EG007|Reported Event|Placebo- Follow up|Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
11249419|NCT02547935|BG000|Baseline|Dapagliflozin 10 mg + Saxagliptin 2.5 mg|Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
11249420|NCT02547935|BG001|Baseline|Dapagliflozin 10 mg|Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
11249421|NCT02547935|BG002|Baseline|Placebo|Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.
11249422|NCT02547935|BG003|Baseline|Total|Total of all reporting groups
11249423|NCT02547935|FG000|Participant Flow|Dapagliflozin 10 mg + Saxagliptin 2.5 mg|Dapagliflozin 10 milligram (mg) and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
11249424|NCT02547935|FG001|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
11249425|NCT02547935|FG002|Participant Flow|Placebo|Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.
11249426|NCT02547935|OG000|Outcome|Dapagliflozin 10 mg + Saxagliptin 2.5 mg|Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
11249427|NCT02547935|OG001|Outcome|Placebo|Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.
11249428|NCT02547935|OG001|Outcome|Dapagliflozin 10 mg|Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
11249429|NCT02547935|OG002|Outcome|Placebo|Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.
11249430|NCT02547935|OG000|Outcome|Dapagliflozin 10 mg|Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
11249431|NCT02547935|EG000|Reported Event|Dapagliflozin 10 mg + Saxagliptin 2.5 mg|Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
11249432|NCT02547935|EG001|Reported Event|Dapagliflozin 10 mg|Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
11249433|NCT02547935|EG002|Reported Event|Placebo|Placebo tablets to match both active products (dapagliflozin and saxagliptin)were taken orally, once daily (in the morning) for 24 weeks.
10969720|NCT00907296|BG010|Baseline|Total|Total of all reporting groups
11249434|NCT02547974|BG000|Baseline|GSK3277513A F1 Group|Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249435|NCT02547974|BG001|Baseline|GSK3277513A F2 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249436|NCT02547974|BG002|Baseline|GSK3277513A F3 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
10820313|NCT00056498|EG000|Reported Event|Risperidone|Participants assigned to risperidone
10969721|NCT00907296|FG000|Participant Flow|Placebo|Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
11249437|NCT02547974|BG003|Baseline|PLACEBO Group|Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249438|NCT02547974|BG004|Baseline|Total|Total of all reporting groups
11249439|NCT02547974|FG000|Participant Flow|GSK3277513A F1 Group|Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249440|NCT02547974|FG001|Participant Flow|GSK3277513A F2 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249441|NCT02547974|FG002|Participant Flow|GSK3277513A F3 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249442|NCT02547974|FG003|Participant Flow|PLACEBO Group|Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249443|NCT02547974|OG000|Outcome|GSK3277513A F1 Group|Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249444|NCT02547974|OG001|Outcome|GSK3277513A F2 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249445|NCT02547974|OG002|Outcome|GSK3277513A F3 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249446|NCT02547974|OG003|Outcome|PLACEBO Group|Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249447|NCT02547974|OG000|Outcome|GSK3277513A F2 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249448|NCT02547974|OG001|Outcome|GSK3277513A F3 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249449|NCT02547974|OG002|Outcome|PLACEBO Group|Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249450|NCT02547974|EG000|Reported Event|GSK3277513A F1 Group|Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249451|NCT02547974|EG001|Reported Event|GSK3277513A F2 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249452|NCT02547974|EG002|Reported Event|GSK3277513A F3 Group|Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249453|NCT02547974|EG003|Reported Event|PLACEBO Group|Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
11249454|NCT02547987|BG000|Baseline|Docetaxel/Carboplatin|"Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles~Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6"
11249455|NCT02547987|FG000|Participant Flow|Docetaxel/Carboplatin|"Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles~Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6"
11249456|NCT02547987|OG000|Outcome|Docetaxel/Carboplatin|"Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles~Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6"
11249457|NCT02547987|EG000|Reported Event|Docetaxel/Carboplatin|"Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles~Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6"
11249458|NCT02548078|BG000|Baseline|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249459|NCT02548078|BG001|Baseline|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249460|NCT02548078|BG002|Baseline|Total|Total of all reporting groups
11249461|NCT02548078|FG000|Participant Flow|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249462|NCT02548078|FG001|Participant Flow|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249463|NCT02548078|OG000|Outcome|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
10820314|NCT00056498|EG001|Reported Event|Placebo|Participants assigned to placebo
11249464|NCT02548078|OG001|Outcome|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249465|NCT02548078|OG000|Outcome|GSK3390107A+Nimenrix 13-17YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
11249466|NCT02548078|OG001|Outcome|Nimenrix+GSK3390107A 13-17YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
11249467|NCT02548078|OG002|Outcome|GSK3390107A+Nimenrix 6-12YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
11249468|NCT02548078|OG003|Outcome|Nimenrix+GSK3390107A 6-12YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
11249469|NCT02548078|OG004|Outcome|GSK3390107A+Nimenrix 1-5YOA Group|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
11249470|NCT02548078|OG005|Outcome|Nimenrix+GSK3390107A 1-5YOA Group|Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
11249471|NCT02548078|OG004|Outcome|GSK3390107A+Nimenrix 1-5YOAGroup|Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
11249472|NCT02548078|EG000|Reported Event|GSK3390107A+Nimenrix Group|Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249473|NCT02548078|EG001|Reported Event|Nimenrix+GSK3390107A Group|Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
11249474|NCT02548156|BG000|Baseline|Overall Study|All the participants randomized in this study.
11249475|NCT02548156|FG000|Participant Flow|Sequence 1: Test/Comparator/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249476|NCT02548156|FG001|Participant Flow|Sequence 2: Test/Reference/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249477|NCT02548156|FG002|Participant Flow|Sequence 3: Comparator/Test/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249478|NCT02548156|FG003|Participant Flow|Sequence 4: Comparator/Reference/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249479|NCT02548156|FG004|Participant Flow|Sequence 5: Reference/Test/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249480|NCT02548156|FG005|Participant Flow|Sequence 6: Reference/Comparator/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
11249481|NCT02548156|OG000|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
11249482|NCT02548156|OG001|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
11249483|NCT02548156|OG002|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
11249484|NCT02548156|EG000|Reported Event|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
11249485|NCT02548156|EG001|Reported Event|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
11249486|NCT02548156|EG002|Reported Event|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
11249487|NCT02548312|BG000|Baseline|Dyspepsia Review- Competing Interest Statement 1|"Honoraria & Travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249488|NCT02548312|BG001|Baseline|Gout Review- Competing Interest Statement 2|"Advisory board & consultancies:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249489|NCT02548312|BG002|Baseline|Dyspepsia Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals"
11249490|NCT02548312|BG003|Baseline|Dyspepsia Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249491|NCT02548312|BG004|Baseline|Gout Review- Competing Interest Statement 1|"Honoraria & travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249492|NCT02548312|BG005|Baseline|Dyapepsia Review- Competing Interest Statement 2|"Advisory board & consultancies.~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249493|NCT02548312|BG006|Baseline|Gout Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.."
10969722|NCT00907296|FG001|Participant Flow|Romosozumab 70 mg: 2 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
11249494|NCT02548312|BG007|Baseline|Gout Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249495|NCT02548312|BG008|Baseline|Total|Total of all reporting groups
11249496|NCT02548312|FG000|Participant Flow|Dyspepsia Review- Competing Interest Statement 1|"Honoraria & Travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249497|NCT02548312|FG001|Participant Flow|Gout Review- Competing Interest Statement 2|"Advisory board & consultancies:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249498|NCT02548312|FG002|Participant Flow|Dyspepsia Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals"
11249499|NCT02548312|FG003|Participant Flow|Dyspepsia Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249500|NCT02548312|FG004|Participant Flow|Gout Review- Competing Interest Statement 1|"Honoraria & travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249501|NCT02548312|FG005|Participant Flow|Dyspepsia Review- Competing Interest Statement 2|"Advisory board & consultancies.~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249502|NCT02548312|FG006|Participant Flow|Gout Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.."
11249503|NCT02548312|FG007|Participant Flow|Gout Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249504|NCT02548312|OG000|Outcome|Dyspepsia Review- Competing Interest Statement 1|"Honoraria & Travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
10969723|NCT00907296|FG002|Participant Flow|Romosozumab 70 mg: 3 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969724|NCT00907296|FG003|Participant Flow|Romosozumab 70 mg: 4 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249505|NCT02548312|OG001|Outcome|Gout Review- Competing Interest Statement 2|"Advisory board & consultancies:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
10969725|NCT00907296|FG004|Participant Flow|Romosozumab 140 mg: 2 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969726|NCT00907296|FG005|Participant Flow|Romosozumab 140 mg: 3 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969727|NCT00907296|FG006|Participant Flow|Romosozumab 140 mg: 4 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
11213599|NCT02287779|EG000|Reported Event|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
11213600|NCT02287779|EG001|Reported Event|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
11213601|NCT02287779|EG002|Reported Event|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
11213602|NCT02287779|EG003|Reported Event|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
11213603|NCT02287779|EG004|Reported Event|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
11213604|NCT02287779|EG005|Reported Event|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
11213605|NCT02287779|EG006|Reported Event|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
11213606|NCT02287779|EG007|Reported Event|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
11213616|NCT02287883|BG000|Baseline|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
11213617|NCT02287883|BG001|Baseline|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
11213618|NCT02287883|BG002|Baseline|Total|Total of all reporting groups
11213619|NCT02287883|FG000|Participant Flow|Patients at High PAE Practices (n=8 Practices)|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities (top quartile).
11213620|NCT02287883|FG001|Participant Flow|Patients at Low PAE Practices (n=8 Practices)|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities (bottom quartile).
11213621|NCT02287883|OG000|Outcome|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
11213622|NCT02287883|OG001|Outcome|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
11213623|NCT02287883|EG000|Reported Event|Patients at High PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities.
11213624|NCT02287883|EG001|Reported Event|Patients at Low PAE Practices|Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities.
11249506|NCT02548312|OG002|Outcome|Dyspepsia Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals"
11249507|NCT02548312|OG003|Outcome|Dyspepsia Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249508|NCT02548312|OG004|Outcome|Gout Review- Competing Interest Statement 1|"Honoraria & travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249509|NCT02548312|OG005|Outcome|Dyspepsia Review- Competing Interest Statement 2|"Advisory board & consultancies.~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249510|NCT02548312|OG006|Outcome|Gout Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.."
11249511|NCT02548312|OG007|Outcome|Gout Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249512|NCT02548312|EG000|Reported Event|Dyspepsia Review- Competing Interest Statement 1|"Honoraria & Travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
10969728|NCT00907296|FG007|Participant Flow|Romosozumab 210 mg: 2 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969729|NCT00907296|FG008|Participant Flow|Romosozumab 210 mg: 3 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969730|NCT00907296|FG009|Participant Flow|Romosozumab 210 mg: 4 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249513|NCT02548312|EG001|Reported Event|Gout Review- Competing Interest Statement 2|"Advisory board & consultancies:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249514|NCT02548312|EG002|Reported Event|Dyspepsia Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals"
11249515|NCT02548312|EG003|Reported Event|Dyspepsia Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249516|NCT02548312|EG004|Reported Event|Gout Review- Competing Interest Statement 1|"Honoraria & travel:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference."
11249517|NCT02548312|EG005|Reported Event|Dyspepsia Review- Competing Interest Statement 2|"Advisory board & consultancies.~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member."
11249518|NCT02548312|EG006|Reported Event|Gout Review- Competing Interest Statement 3|"Research funding:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.."
11249519|NCT02548312|EG007|Reported Event|Gout Review- Competing Interest Statement 4|"None:~We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests."
11249520|NCT02548455|BG000|Baseline|Treatment|"Left Ventricular Lead model Quartet 1457Q~Left Ventricular Lead"
11249521|NCT02548455|FG000|Participant Flow|Treatment|"Left Ventricular Lead model Quartet 1457Q~Left Ventricular Lead"
11249522|NCT02548455|OG000|Outcome|Treatment|Subjects implanted with the Quartet 1457Q left ventricular lead
11249523|NCT02548455|EG000|Reported Event|Treatment|Subjects implanted with the Quartet 1457Q left ventricular lead
11249524|NCT02548585|BG000|Baseline|Placebo|Participants received placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
11249525|NCT02548585|BG001|Baseline|Cohort 1: MEDI0382 100 mcg|Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
11249526|NCT02548585|BG002|Baseline|Cohort 2: MEDI0382 150 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
10969731|NCT00907296|OG000|Outcome|Placebo|Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
10969732|NCT00907296|OG001|Outcome|Romosozumab 70 mg: 2 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969733|NCT00907296|OG002|Outcome|Romosozumab 70 mg: 3 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
11249527|NCT02548585|BG003|Baseline|Cohort 3: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
11249528|NCT02548585|BG004|Baseline|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
10969734|NCT00907296|OG003|Outcome|Romosozumab 70 mg: 4 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
10969735|NCT00907296|OG004|Outcome|Romosozumab 140 mg: 2 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969736|NCT00907296|OG005|Outcome|Romosozumab 140 mg: 3 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969737|NCT00907296|OG006|Outcome|Romosozumab 140 mg: 4 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
10969738|NCT00907296|OG007|Outcome|Romosozumab 210 mg: 2 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969739|NCT00907296|OG008|Outcome|Romosozumab 210 mg: 3 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969740|NCT00907296|OG009|Outcome|Romosozumab 210 mg: 4 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
10969741|NCT00907296|EG000|Reported Event|Placebo|Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
10969742|NCT00907296|EG001|Reported Event|Romosozumab 70 mg: 2 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969743|NCT00907296|EG002|Reported Event|Romosozumab 70 mg: 3 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969744|NCT00907296|EG003|Reported Event|Romosozumab 70 mg: 4 Doses|Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
10969745|NCT00907296|EG004|Reported Event|Romosozumab 140 mg: 2 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12
10969746|NCT00907296|EG005|Reported Event|Romosozumab 140 mg: 3 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12
10969747|NCT00907296|EG006|Reported Event|Romosozumab 140 mg: 4 Doses|Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
11249529|NCT02548585|BG005|Baseline|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249530|NCT02548585|BG006|Baseline|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249531|NCT02548585|BG007|Baseline|TOTAL|Total of all reporting groups
10969748|NCT00907296|EG007|Reported Event|Romosozumab 210 mg: 2 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
10969749|NCT00907296|EG008|Reported Event|Romosozumab 210 mg: 3 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
10969750|NCT00907296|EG009|Reported Event|Romosozumab 210 mg: 4 Doses|Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
10969751|NCT00907335|BG000|Baseline|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
10969752|NCT00907335|BG001|Baseline|Vehicle Control|Color matched facial gel vehicle control used once daily
10969753|NCT00907335|BG002|Baseline|Total|Total of all reporting groups
10969754|NCT00907335|FG000|Participant Flow|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
10969755|NCT00907335|FG001|Participant Flow|Vehicle Control|Color matched facial gel vehicle control used once daily
10969756|NCT00907335|OG000|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
10969757|NCT00907335|OG001|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
10969758|NCT00907335|EG000|Reported Event|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
10969759|NCT00907335|EG001|Reported Event|Vehicle Control|Color matched facial gel vehicle control used once daily
10969760|NCT00907374|BG000|Baseline|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
10969761|NCT00907374|BG001|Baseline|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
10969762|NCT00907374|BG002|Baseline|Total|Total of all reporting groups
10969763|NCT00907374|FG000|Participant Flow|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
10969764|NCT00907374|FG001|Participant Flow|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
10969765|NCT00907374|OG000|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
11249532|NCT02548585|FG000|Participant Flow|Placebo|Participants received placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
10969766|NCT00907374|OG001|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
11249533|NCT02548585|FG001|Participant Flow|Cohort 1: MEDI0382 100 mcg|Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
11249534|NCT02548585|FG002|Participant Flow|Cohort 2: MEDI0382 150 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
11249535|NCT02548585|FG003|Participant Flow|Cohort 3: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
11249536|NCT02548585|FG004|Participant Flow|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
11249537|NCT02548585|FG005|Participant Flow|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249538|NCT02548585|FG006|Participant Flow|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249539|NCT02548585|OG000|Outcome|Cohort 4: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
11249540|NCT02548585|OG001|Outcome|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
11249541|NCT02548585|OG000|Outcome|Cohort 1: Placebo|Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
11249542|NCT02548585|OG001|Outcome|Cohort 1: MEDI0382 100 mcg|Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
11249543|NCT02548585|OG002|Outcome|Cohort 2: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
11249544|NCT02548585|OG003|Outcome|Cohort 2: MEDI0382 150 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
11249545|NCT02548585|OG004|Outcome|Cohort 3: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
11249546|NCT02548585|OG005|Outcome|Cohort 3: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
11249547|NCT02548585|OG006|Outcome|Cohort 5: Placebo|Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
11249548|NCT02548585|OG007|Outcome|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249549|NCT02548585|OG008|Outcome|Cohort 6: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
11249550|NCT02548585|OG009|Outcome|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249551|NCT02548585|OG002|Outcome|Cohort 5: Placebo|Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
11249552|NCT02548585|OG003|Outcome|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249553|NCT02548585|OG004|Outcome|Cohort 6: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
11249554|NCT02548585|OG005|Outcome|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249555|NCT02548585|OG006|Outcome|Cohort 4: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
11249556|NCT02548585|OG007|Outcome|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
11249557|NCT02548585|OG008|Outcome|Cohort 5: Placebo|Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
11249558|NCT02548585|OG009|Outcome|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249559|NCT02548585|OG010|Outcome|Cohort 6: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
11249560|NCT02548585|OG011|Outcome|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249561|NCT02548585|OG000|Outcome|Cohort 1: MEDI0382 100 mcg|Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
11249562|NCT02548585|OG001|Outcome|Cohort 2: MEDI0382 150 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
10969767|NCT00907374|EG000|Reported Event|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
11249563|NCT02548585|OG002|Outcome|Cohort 3: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
11249564|NCT02548585|OG003|Outcome|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
11249565|NCT02548585|OG004|Outcome|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249566|NCT02548585|EG000|Reported Event|Cohort 1: Placebo|Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
11249567|NCT02548585|EG001|Reported Event|Cohort 1: MEDI0382 100 mcg|Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
11249568|NCT02548585|EG002|Reported Event|Cohort 2: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
11249569|NCT02548585|EG003|Reported Event|Cohort 2: MEDI0382 150 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
11249570|NCT02548585|EG004|Reported Event|Cohort 3: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
10969768|NCT00907374|EG001|Reported Event|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
11249571|NCT02548585|EG005|Reported Event|Cohort 3: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15). )
11249572|NCT02548585|EG006|Reported Event|Cohort 4: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
11249573|NCT02548585|EG007|Reported Event|Cohort 4: MEDI0382 200 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
11249574|NCT02548585|EG008|Reported Event|Cohort 5: Placebo|Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
11249575|NCT02548585|EG009|Reported Event|Cohort 5: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
11249576|NCT02548585|EG010|Reported Event|Cohort 6: Placebo|Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
11249577|NCT02548585|EG011|Reported Event|Cohort 6: MEDI0382 300 mcg|Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
11249578|NCT02548650|BG000|Baseline|Patients With Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249579|NCT02548650|BG001|Baseline|Patients Without Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249580|NCT02548650|BG002|Baseline|Total|Total of all reporting groups
11249581|NCT02548650|FG000|Participant Flow|Patients With Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249582|NCT02548650|FG001|Participant Flow|Patients Without Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249583|NCT02548650|OG000|Outcome|Triple Therapy|vorapaxar plus DAPT
11249584|NCT02548650|OG001|Outcome|Dual Therapy|(vorapaxar plus clopidogrel)
11249585|NCT02548650|EG000|Reported Event|Patients With Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249586|NCT02548650|EG001|Reported Event|Patients Without Diabetes|Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
11249587|NCT02548728|BG000|Baseline|Oxytocin|"Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.~Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days"
11249588|NCT02548728|BG001|Baseline|Placebo|"Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.~Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day"
11249589|NCT02548728|BG002|Baseline|Total|Total of all reporting groups
11249590|NCT02548728|FG000|Participant Flow|Oxytocin|"Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.~Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days"
11249591|NCT02548728|FG001|Participant Flow|Placebo|"Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.~Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day"
11249592|NCT02548728|OG000|Outcome|Oxytocin|"Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.~Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days"
11249593|NCT02548728|OG001|Outcome|Placebo|"Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.~Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day"
10969769|NCT00907426|BG000|Baseline|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
11249594|NCT02548728|EG000|Reported Event|Oxytocin|"Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.~Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days"
11249595|NCT02548728|EG001|Reported Event|Placebo|"Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.~Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day"
11249596|NCT02548845|BG000|Baseline|Oncology Patients With Hyponatraemia|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L)
11249597|NCT02548845|FG000|Participant Flow|Oncology Patients With Hyponatraemia|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L)
11249598|NCT02548845|OG000|Outcome|Oncology Patients With Hyponatraemia|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L)
11249599|NCT02548845|OG000|Outcome|Participants Treated According to SEOM Algorithm|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm.
11249600|NCT02548845|OG001|Outcome|Participant NOT Treated According to SEOM Algorithm|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
11249601|NCT02548845|OG000|Outcome|Subjects With Chemotherapy Treated as Per SEOM Algorithm|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred.
11249602|NCT02548845|OG001|Outcome|Subjects With Chemotherapy NOT Treated as Per SEOM Algorithm|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH NOT according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred
11249603|NCT02548845|EG000|Reported Event|Oncology Patients With Hyponatraemia|Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L)
11249604|NCT02548910|BG000|Baseline|Phlebotomy|"For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.~Phlebotomy: A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.~Citrated whole blood collection bag: Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood."
11249605|NCT02548910|BG001|Baseline|Control|Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
11249606|NCT02548910|BG002|Baseline|Total|Total of all reporting groups
11249607|NCT02548910|FG000|Participant Flow|Phlebotomy|"For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.~Phlebotomy: A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.~Citrated whole blood collection bag: Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood."
11249608|NCT02548910|FG001|Participant Flow|Control|Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
11249609|NCT02548910|OG000|Outcome|Phlebotomy|"For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.~Phlebotomy: A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.~Citrated whole blood collection bag: Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood."
11249610|NCT02548910|OG001|Outcome|Control|Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
11249611|NCT02548910|OG000|Outcome|Participant Accrual|Enrolment of participants in either group (Phlebotomy or Control)
11286375|NCT02887404|BG001|Baseline|Usual Care|"Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Usual Care: Standard of pain management care"
11249612|NCT02548910|EG000|Reported Event|Phlebotomy|"For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.~Phlebotomy: A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.~Citrated whole blood collection bag: Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood."
11249613|NCT02548910|EG001|Reported Event|Control|Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.
11249614|NCT02548949|BG000|Baseline|Pristiq|Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
11249615|NCT02548949|FG000|Participant Flow|Pristiq|Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
11249616|NCT02548949|OG000|Outcome|Pristiq|Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
11249617|NCT02548949|EG000|Reported Event|Pristiq|Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
11249618|NCT02548962|BG000|Baseline|Phase 1: Dose Finding (560mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (560mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249619|NCT02548962|BG001|Baseline|Phase 1: Dose Finding (840mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (840mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249620|NCT02548962|BG002|Baseline|Total|Total of all reporting groups
11249621|NCT02548962|FG000|Participant Flow|Phase 1: Dose Finding (560mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (560mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249622|NCT02548962|FG001|Participant Flow|Phase 1: Dose Finding (840mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (840mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249623|NCT02548962|OG000|Outcome|Phase 1: Dose Finding (560mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (560mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249624|NCT02548962|OG001|Outcome|Phase 1: Dose Finding (840mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (840mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249625|NCT02548962|OG000|Outcome|Phase 1: Dose Finding (560 mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (560mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249626|NCT02548962|OG001|Outcome|Phase 1: Dose Finding (840 mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (840mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249627|NCT02548962|EG000|Reported Event|Phase 1: Dose Finding (560mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (560mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249628|NCT02548962|EG001|Reported Event|Phase 1: Dose Finding (840mg)|"Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO~Ibrutinib (840mg)~Pomalidomide (4mg)~Dexamethasone (40mg)"
11249629|NCT02549014|BG000|Baseline|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249630|NCT02549014|BG001|Baseline|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
11249631|NCT02549014|BG002|Baseline|Total|Total of all reporting groups
11249632|NCT02549014|FG000|Participant Flow|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249633|NCT02549014|FG001|Participant Flow|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
11286376|NCT02887404|BG002|Baseline|Total|Total of all reporting groups
11249634|NCT02549014|OG000|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249635|NCT02549014|OG001|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249636|NCT02549014|OG002|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249637|NCT02549014|OG003|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249638|NCT02549014|OG004|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249639|NCT02549014|OG005|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249640|NCT02549014|OG006|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249641|NCT02549014|OG007|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249642|NCT02549014|OG008|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
11249643|NCT02549014|OG009|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
11249644|NCT02549014|OG010|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249645|NCT02549014|EG000|Reported Event|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249646|NCT02549014|EG001|Reported Event|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249647|NCT02549014|EG002|Reported Event|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249648|NCT02549014|EG003|Reported Event|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249649|NCT02549014|EG004|Reported Event|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249650|NCT02549014|EG005|Reported Event|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249651|NCT02549014|EG006|Reported Event|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249652|NCT02549014|EG007|Reported Event|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249653|NCT02549014|EG008|Reported Event|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
11249654|NCT02549014|EG009|Reported Event|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
11249655|NCT02549014|EG010|Reported Event|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
11249656|NCT02549027|BG000|Baseline|All Study Participants|
11249657|NCT02549027|FG000|Participant Flow|MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)|Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
11249658|NCT02549027|FG001|Participant Flow|MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)|Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
11249659|NCT02549027|FG002|Participant Flow|MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)|Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
11249660|NCT02549027|FG003|Participant Flow|MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)|Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
11249661|NCT02549027|FG004|Participant Flow|MK-6096 20 mg (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.
11249662|NCT02549027|FG005|Participant Flow|Placebo (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.
11249663|NCT02549027|OG000|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
11249664|NCT02549027|OG001|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
11249665|NCT02549027|OG002|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
11249666|NCT02549027|OG003|Outcome|Placebo|Single dose of placebo
11249667|NCT02549027|OG000|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
11249668|NCT02549027|OG001|Outcome|Placebo|Single dose of placebo
11249669|NCT02549027|OG003|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
11249670|NCT02549027|OG004|Outcome|Placebo|Single dose of placebo
11249671|NCT02549027|EG000|Reported Event|MK-1064 50 mg|Single dose of 50 mg MK-1064
11249672|NCT02549027|EG001|Reported Event|MK-1064 120 mg|Single dose of 120 mg MK-1064
11249673|NCT02549027|EG002|Reported Event|MK-1064 250 mg|Single dose of 250 mg MK-1064
11249674|NCT02549027|EG003|Reported Event|MK-6096 20 mg|Single dose of 20 mg MK-6096
11249675|NCT02549027|EG004|Reported Event|Placebo|Single dose of placebo
11249676|NCT02549040|BG000|Baseline|MK-1439 Fixed Sequence Treatment|After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: MK-1439 Type 1 dose (150 mg tablet [40% drug loaded granule]). During Period 2, participants received Treatment A: MK-1439 100 mg film coated tablet. During Period 3, participants received Treatment C: MK-1439 Type 2 dose (150 mg tablet [30% drug loaded granule]). During Period 4, participants received Treatment D: MK-1439 Type 3 dose (150 mg tablet [50% drug loaded granule]. During Period 5, participants received Treatment E: MK-1439 Type 4 dose (100 mg tablet [30% drug loaded granule]). Each period was separated by a 14 day washout.
11249677|NCT02549040|FG000|Participant Flow|MK-1439 Fixed Sequence Treatment|After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: MK-1439 Type 1 dose (150 mg tablet [40% drug loaded granule]). During Period 2, participants received Treatment A: MK-1439 100 mg film coated tablet. During Period 3, participants received Treatment C: MK-1439 Type 2 dose (150 mg tablet [30% drug loaded granule]). During Period 4, participants received Treatment D: MK-1439 Type 3 dose (150 mg tablet [50% drug loaded granule]. During Period 5, participants received Treatment E: MK-1439 Type 4 dose (100 mg tablet [30% drug loaded granule]). Each period was separated by a 14 day washout.
11249678|NCT02549040|OG000|Outcome|Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)|Participants received a single MK-1439 Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1
11249679|NCT02549040|OG001|Outcome|Treatment A: MK-1439 100 mg Film Coated Tablet|Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
11249680|NCT02549040|OG002|Outcome|Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)|Participants received a single MK-1439 Type 2 dose (150 mg tablet [30% drug loaded granule]) administered orally at the start of Period 3
11249681|NCT02549040|OG003|Outcome|Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)|Participants received a single MK-1439 Type 3 dose (150 mg tablet [50% drug loaded granule]) administered orally at the start of Period 4
11249682|NCT02549040|OG004|Outcome|Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)|Participants received a single MK-1439 Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5
11249683|NCT02549040|EG000|Reported Event|Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)|Participants received a single MK-1439 Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1
11249684|NCT02549040|EG001|Reported Event|Treatment A: MK-1439 100 mg Film Coated Tablet|Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
11249685|NCT02549040|EG002|Reported Event|Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)|Participants received a single MK-1439 Type 2 dose (150 mg tablet [30% drug loaded granule]) administered orally at the start of Period 3
11249686|NCT02549040|EG003|Reported Event|Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)|Participants received a single MK-1439 Type 3 dose (150 mg tablet [50% drug loaded granule]) administered orally at the start of Period 4
11249687|NCT02549040|EG004|Reported Event|Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)|Participants received a single MK-1439 Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5
11249688|NCT02549196|BG000|Baseline|Cohort 1|Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249689|NCT02549196|BG001|Baseline|Cohort 2|Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249690|NCT02549196|BG002|Baseline|Cohort 1b|Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249691|NCT02549196|BG003|Baseline|Cohort 3c|Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
11249692|NCT02549196|BG004|Baseline|Total|Total of all reporting groups
11249693|NCT02549196|FG000|Participant Flow|Cohort 1|Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249694|NCT02549196|FG001|Participant Flow|Cohort 2|Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249695|NCT02549196|FG002|Participant Flow|Cohort 1b|Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249696|NCT02549196|FG003|Participant Flow|Cohort 3c|Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
11249697|NCT02549196|OG000|Outcome|Cohort 1|Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249698|NCT02549196|OG001|Outcome|Cohort 2|Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249699|NCT02549196|OG002|Outcome|Cohort 1b|Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249700|NCT02549196|OG003|Outcome|Cohort 3c|Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
11249701|NCT02549196|EG000|Reported Event|Cohort 1|Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249702|NCT02549196|EG001|Reported Event|Cohort 2|Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249703|NCT02549196|EG002|Reported Event|Cohort 1b|Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
11249704|NCT02549196|EG003|Reported Event|Cohort 3c|Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
11249705|NCT02549287|BG000|Baseline|SafeCare|SafeCare, an evidence-based home visiting program
11249706|NCT02549287|BG001|Baseline|Supportive Case Management|Child welfare services as usual
11249707|NCT02549287|BG002|Baseline|Total|Total of all reporting groups
11249708|NCT02549287|FG000|Participant Flow|SafeCare|SafeCare, an evidence-based home visiting program
11249709|NCT02549287|FG001|Participant Flow|Supportive Case Management|Child welfare services as usual
11249710|NCT02549287|OG000|Outcome|SafeCare|SafeCare, an evidence-based home visiting program
11249711|NCT02549287|OG001|Outcome|Supportive Case Management|Child welfare services as usual
11249712|NCT02549287|EG000|Reported Event|SafeCare|SafeCare, an evidence-based home visiting program
11249713|NCT02549287|EG001|Reported Event|Supportive Case Management|Child welfare services as usual
11249714|NCT02549339|BG000|Baseline|LEO 43204 0.018% Gel|Treatment once daily for 3 days with LEO 43204 0.018% gel
11249715|NCT02549339|BG001|Baseline|Vehicle Gel|Treatment once daily for 3 days with vehicle gel
11249716|NCT02549339|BG002|Baseline|Total|Total of all reporting groups
11249717|NCT02549339|FG000|Participant Flow|LEO 43204 0.018% Gel|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
11249718|NCT02549339|FG001|Participant Flow|Vehicle Gel|Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
11249719|NCT02549339|OG000|Outcome|LEO 43204 0.018% Gel|Treatment once daily for 3 days with LEO 43204 0.018% gel
11249720|NCT02549339|OG001|Outcome|Vehicle Gel|Treatment once daily for 3 days with vehicle gel
11249721|NCT02549339|EG000|Reported Event|LEO 43204 0.018% Gel|Treatment once daily for 3 days LEO 43204 0.018% gel
11249722|NCT02549339|EG001|Reported Event|Vehicle Gel|Treatment once daily for 3 days Vehicle gel
11249723|NCT02549339|EG002|Reported Event|LEO 43204 0.018% Gel - Extended Follow-up|Treatment once daily for 3 days LEO 43204 0.018% gel
11249724|NCT02549339|EG003|Reported Event|Vehicle Gel - Extended Follow-up|Treatment once daily for 3 days Vehicle gel
11249725|NCT02549352|BG000|Baseline|LEO 43204 0.037% Gel|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249726|NCT02549352|BG001|Baseline|Vehicle Gel|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249727|NCT02549352|BG002|Baseline|Total|Total of all reporting groups
11249728|NCT02549352|FG000|Participant Flow|LEO 43204 0.037% Gel|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249729|NCT02549352|FG001|Participant Flow|Vehicle Gel|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249730|NCT02549352|OG000|Outcome|LEO 43204 0.037% Gel|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249731|NCT02549352|OG001|Outcome|Vehicle Gel|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249732|NCT02549352|EG000|Reported Event|LEO 43204 0.037% Gel|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249733|NCT02549352|EG001|Reported Event|Vehicle Gel|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249734|NCT02549352|EG002|Reported Event|LEO 43204 0.037% Gel - Extended Follow-up|Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
11249735|NCT02549352|EG003|Reported Event|Vehicle Gel - Extended Follow-up|Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
11249736|NCT02549365|BG000|Baseline|Intervention|"Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.~Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season~Surveillance (nasal swabbing) during influenza season"
11249737|NCT02549365|BG001|Baseline|Controls|"Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.~Surveillance (nasal swabbing) during influenza season"
10969770|NCT00907426|BG001|Baseline|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969771|NCT00907426|BG002|Baseline|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969772|NCT00907426|BG003|Baseline|Total|Total of all reporting groups
10969773|NCT00907426|FG000|Participant Flow|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
11249738|NCT02549365|BG002|Baseline|Total|Total of all reporting groups
11249739|NCT02549365|FG000|Participant Flow|Intervention|"Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.~Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season~Surveillance (nasal swabbing) during influenza season"
11249740|NCT02549365|FG001|Participant Flow|Controls|"Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.~Surveillance (nasal swabbing) during influenza season"
11249741|NCT02549365|OG000|Outcome|Intervention|"Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.~Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season~Surveillance (nasal swabbing) during influenza season"
11249742|NCT02549365|OG001|Outcome|Controls|"Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.~Surveillance (nasal swabbing) during influenza season"
11249743|NCT02549365|OG000|Outcome|Intervention|Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Blood sample and/or oral fluid sample taken prior to, and 6 weeks post LAIV as per protocol.
11249744|NCT02549365|EG000|Reported Event|Intervention|"Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.~Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season~Surveillance (nasal swabbing) during influenza season~NB: Adverse Events were not monitored/assessed for the Household Controls"
11249745|NCT02549508|BG000|Baseline|AutoCPAP With SensAwake On First, Then SensAwake Off|"Randomized participants in this group will experience SensaAwake On first while using AutoCPAP for the first 4 weeks of the intervention.~After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake off while using AutoCPAP."
11249746|NCT02549508|BG001|Baseline|AutoCPAP With SensAwake Off First, Then SensAwake On|"Randomized participants in this group will experience SensaAwake Off first while using AutoCPAP for the first 4 weeks of the intervention.~After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake On while using AutoCPAP."
11249747|NCT02549508|BG002|Baseline|Total|Total of all reporting groups
10969774|NCT00907426|FG001|Participant Flow|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969775|NCT00907426|FG002|Participant Flow|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969776|NCT00907426|OG000|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
10969777|NCT00907426|OG001|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
10969778|NCT00907426|EG000|Reported Event|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969779|NCT00907426|EG001|Reported Event|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969780|NCT00907426|EG002|Reported Event|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
10969781|NCT00907478|BG000|Baseline|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
11249748|NCT02549508|FG000|Participant Flow|AutoCPAP With SensAwake On First, Then SensAwake Off|"Randomized participants in this group will experience SensAwake On first while using AutoCPAP for the first 4 weeks of the intervention.~After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake off while using AutoCPAP."
11249749|NCT02549508|FG001|Participant Flow|AutoCPAP With SensAwake Off First, Then SensAwake On|"Randomized participants in this group will experience SensAwake Off first while using AutoCPAP for the first 4 weeks of the intervention.~After 4 weeks, participants will cross over to the opposite arm and complete 4 weeks with SensAwake on while using AutoCPAP."
11249750|NCT02549508|OG000|Outcome|AutoCPAP With SensAwake On|Analysis of all participants who completed the AutoCPAP with SensAwake on arm.
11249751|NCT02549508|OG001|Outcome|AutoCPAP With SensAwake Off First|Analysis of all participants who completed the AutoCPAP with SensAwake off arm
11249752|NCT02549508|OG000|Outcome|AutoCPAP With SensAwake On|Analysis of all participants who completed the AutoCPAP with SensAwake on arm
11249753|NCT02549508|OG001|Outcome|AutoCPAP With SensAwake Off|Analysis of all participants who completed the AutoCPAP with SensAwake off arm
11249754|NCT02549508|EG000|Reported Event|AutoCPAP With SensAwake On|Includes data for all participants who were exposed at any point of the 8 week study to SensAwake On. Due to drop outs, not all participants were exposed to this intervention.
11249755|NCT02549508|EG001|Reported Event|AutoCPAP With SensAwake Off|Includes data for all participants who were exposed at any point of the 8 week study to SensAwake Off. Due to drop outs, not all participants were exposed to this intervention.
11249756|NCT02549573|BG000|Baseline|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the APO+ group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249757|NCT02549573|BG001|Baseline|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the APO- group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No rescue therapy will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249758|NCT02549573|BG002|Baseline|Total|Total of all reporting groups
11249759|NCT02549573|FG000|Participant Flow|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the APO+ group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249760|NCT02549573|FG001|Participant Flow|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the APO- group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No rescue therapy will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249761|NCT02549573|OG000|Outcome|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the APO+ group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249762|NCT02549573|OG001|Outcome|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the APO- group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No rescue therapy will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11286377|NCT02887404|FG000|Participant Flow|Spine Surgery Analgesic Pathway|"Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Spine surgery analgesic pathway: Enhanced pain management care"
10969782|NCT00907478|BG001|Baseline|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
10969783|NCT00907478|BG002|Baseline|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
10969784|NCT00907478|BG003|Baseline|Total|Total of all reporting groups
10969785|NCT00907478|FG000|Participant Flow|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
11249763|NCT02549573|EG000|Reported Event|Apokyn Treatment Before Physical Therapy|"APOKYN treatment before the PT Intervention Visit. Subjects in the APO+ group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~APOKYN: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249764|NCT02549573|EG001|Reported Event|Apokyn Treatment Withheld Before Physical Therapy|"APOKYN treatment withheld before the PT Intervention Visit. Subjects in the APO- group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No rescue therapy will be allowed during the PT Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.~Physical Therapy: All subjects will participate in a standardized PT intervention"
11249765|NCT02549859|BG000|Baseline|Deep Brain Stimulation (DBS)|All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.
11249766|NCT02549859|FG000|Participant Flow|Deep Brain Stimulation (DBS)|All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.
11249767|NCT02549859|OG000|Outcome|DBS 60Hz|Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
11249768|NCT02549859|OG001|Outcome|DBS 130Hz|Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
11249769|NCT02549859|OG002|Outcome|DBS Off|Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
11249770|NCT02549859|EG000|Reported Event|DBS 60Hz|Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
11249771|NCT02549859|EG001|Reported Event|DBS 130Hz|Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
10969786|NCT00907478|FG001|Participant Flow|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
11249772|NCT02549859|EG002|Reported Event|DBS Off|Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
11249773|NCT02550106|BG000|Baseline|OMALIZUMAB|sub cutaneous injections of 300 mg every 4 weeks until Week 8
11249774|NCT02550106|FG000|Participant Flow|OMALIZUMAB|sub cutaneous injections of 300 mg every 4 weeks until Week 8
11249775|NCT02550106|OG000|Outcome|OMALIZUMAB With ANGIOEDEMA|sub cutaneous injections of 300 mg every 4 weeks until W8
11249776|NCT02550106|OG001|Outcome|OMALIZUMAB Without Angioedema|sub cutaneaous injections of 300 mg every 4 weeks until Week 8
11249777|NCT02550106|OG001|Outcome|OMALIZUMAB Without ANGIOEDEMA|sub cutaneous injections of 300 mg every 4 weeks until W8
11249778|NCT02550106|EG000|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg
11249779|NCT02550132|BG000|Baseline|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
11249780|NCT02550132|FG000|Participant Flow|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
11249781|NCT02550132|OG000|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
11249782|NCT02550132|EG000|Reported Event|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
10969787|NCT00907478|FG002|Participant Flow|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
10969788|NCT00907478|OG000|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
10969789|NCT00907478|OG001|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
11249783|NCT02550210|BG000|Baseline|Breast Cancer Locator (BCL)|"The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.~Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."
11249784|NCT02550210|FG000|Participant Flow|Breast Cancer Locator (BCL)|"The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.~Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."
11249785|NCT02550210|OG000|Outcome|Breast Cancer Locator (BCL)|"The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.~Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."
11249786|NCT02550210|EG000|Reported Event|Breast Cancer Locator (BCL)|"The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure.~Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin."
11249787|NCT02550743|BG000|Baseline|Dose 1|"BYL719, capectabine and radiation Dose: 200mg/day~BYL719~Capecitabine~Radiation"
11249788|NCT02550743|BG001|Baseline|Dose 2|"BYL719, capectabine and radiation Dose: 250mg/day~BYL719~Capecitabine~Radiation"
11249789|NCT02550743|BG002|Baseline|Dose 3|"BYL719, capectabine and radiation Dose: 300mg/day~BYL719~Capecitabine~Radiation"
10969790|NCT00907478|OG002|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
11249790|NCT02550743|BG003|Baseline|Dose -1|"BYL719, capectabine and radiation Dose: 150mg/day~BYL719~Capecitabine~Radiation"
11249791|NCT02550743|BG004|Baseline|Total|Total of all reporting groups
11249792|NCT02550743|FG000|Participant Flow|Dose 1|"BYL719, capectabine and radiation Dose: 200mg/day~BYL719~Capecitabine~Radiation"
11249793|NCT02550743|FG001|Participant Flow|Dose 2|"BYL719, capectabine and radiation Dose: 250mg/day~BYL719~Capecitabine~Radiation"
11249794|NCT02550743|FG002|Participant Flow|Dose 3|"BYL719, capectabine and radiation Dose: 300mg/day~BYL719~Capecitabine~Radiation"
11249795|NCT02550743|FG003|Participant Flow|Dose -1|"BYL719, capectabine and radiation Dose: 150mg/day~BYL719~Capecitabine~Radiation"
11249796|NCT02550743|OG000|Outcome|Maximum Tolerated Dose of BYL719|BYL719, capectabine and radiation
11249797|NCT02550743|OG000|Outcome|Dose 1|"BYL719, capectabine and radiation Dose: 200mg/day~BYL719~Capecitabine~Radiation"
11249798|NCT02550743|OG001|Outcome|Dose 2|"BYL719, capectabine and radiation Dose: 250mg/day~BYL719~Capecitabine~Radiation"
11249799|NCT02550743|OG002|Outcome|Dose 3|"BYL719, capectabine and radiation Dose: 300mg/day~BYL719~Capecitabine~Radiation"
11249800|NCT02550743|OG003|Outcome|Dose -1|"BYL719, capectabine and radiation Dose: 150mg/day~BYL719~Capecitabine~Radiation"
11249801|NCT02550743|EG000|Reported Event|Dose 1|"BYL719, capectabine and radiation Dose: 200mg/day~BYL719~Capecitabine~Radiation"
11249802|NCT02550743|EG001|Reported Event|Dose 2|"BYL719, capectabine and radiation Dose: 250mg/day~BYL719~Capecitabine~Radiation"
11249803|NCT02550743|EG002|Reported Event|Dose 3|"BYL719, capectabine and radiation Dose: 300mg/day~BYL719~Capecitabine~Radiation"
11249804|NCT02550743|EG003|Reported Event|Dose -1|"BYL719, capectabine and radiation Dose: 150mg/day~BYL719~Capecitabine~Radiation"
11249805|NCT02550795|BG000|Baseline|Control|"administration of 0.9% normal saline 10ml~Control: administration of normal saline"
11249806|NCT02550795|BG001|Baseline|Dexmedetomidine|"administration of 0.5ug/kg of dexmedetomidine (5ml)~Dexmedetomidine: administration of dexmedetomidine only"
11249807|NCT02550795|BG002|Baseline|Dexmedetomidine and Dexamethasone|"administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)~Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone"
10969791|NCT00907478|OG000|Outcome|Romiplostim|Participants received once weekly romiplostim for 3 years.
10969792|NCT00907478|EG000|Reported Event|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
10969793|NCT00907478|EG001|Reported Event|Cohort 2|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
11249808|NCT02550795|BG003|Baseline|Total|Total of all reporting groups
11249809|NCT02550795|FG000|Participant Flow|Control|"administration of 0.9% normal saline 10ml~Control: administration of normal saline"
11249810|NCT02550795|FG001|Participant Flow|Dexmedetomidine|"administration of 0.5ug/kg of dexmedetomidine (5ml)~Dexmedetomidine: administration of dexmedetomidine only"
11249811|NCT02550795|FG002|Participant Flow|Dexmedetomidine and Dexamethasone|"administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)~Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone"
11249812|NCT02550795|OG000|Outcome|Control|"administration of 0.9% normal saline 10ml~Control: administration of normal saline"
11249813|NCT02550795|OG001|Outcome|Dexmedetomidine|"administration of 0.5ug/kg of dexmedetomidine (5ml)~Dexmedetomidine: administration of dexmedetomidine only"
11249814|NCT02550795|OG002|Outcome|Dexmedetomidine and Dexamethasone|"administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)~Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone"
11249815|NCT02550795|EG000|Reported Event|Control|"administration of 0.9% normal saline 10ml~Control: administration of normal saline"
11249816|NCT02550795|EG001|Reported Event|Dexmedetomidine|"administration of 0.5ug/kg of dexmedetomidine (5ml)~Dexmedetomidine: administration of dexmedetomidine only"
11249817|NCT02550795|EG002|Reported Event|Dexmedetomidine and Dexamethasone|"administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)~Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone"
11249818|NCT02550938|BG000|Baseline|7 Aligner Cohort Weartime 1|"Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
10969794|NCT00907478|EG002|Reported Event|Cohort 3|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
10969795|NCT00907478|EG003|Reported Event|Overall|Participants received once weekly romiplostim for 3 years.
11249819|NCT02550938|BG001|Baseline|7 Aligner Cohort Weartime 2|"Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249820|NCT02550938|BG002|Baseline|12 Aligner Cohort Weartime 1|"Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249821|NCT02550938|BG003|Baseline|12 Aligner Cohort Weartime 2|"Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249822|NCT02550938|BG004|Baseline|Total|Total of all reporting groups
11249823|NCT02550938|FG000|Participant Flow|7 Aligner Cohort Weartime 1|"Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249824|NCT02550938|FG001|Participant Flow|7 Aligner Cohort Weartime 2|"Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249825|NCT02550938|FG002|Participant Flow|12 Aligner Cohort Weartime 1|"Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249826|NCT02550938|FG003|Participant Flow|12 Aligner Cohort Weartime 2|"Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249827|NCT02550938|OG000|Outcome|7 Aligner Cohort Weartime 1|"Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249828|NCT02550938|OG001|Outcome|7 Aligner Cohort Weartime 2|"Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249829|NCT02550938|OG002|Outcome|12 Aligner Cohort Weartime 1|"Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249830|NCT02550938|OG003|Outcome|12 Aligner Cohort Weartime 2|"Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249831|NCT02550938|EG000|Reported Event|7 Aligner Cohort Weartime 1|"Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249832|NCT02550938|EG001|Reported Event|7 Aligner Cohort Weartime 2|"Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
10969796|NCT00907517|BG000|Baseline|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
11249833|NCT02550938|EG002|Reported Event|12 Aligner Cohort Weartime 1|"Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249834|NCT02550938|EG003|Reported Event|12 Aligner Cohort Weartime 2|"Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.~Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision."
11249835|NCT02551055|BG000|Baseline|MLN1117 300 mg + Alisertib|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
11249836|NCT02551055|BG001|Baseline|MLN1117 600 mg + Alisertib|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
11249837|NCT02551055|BG002|Baseline|MLN1117 300 mg + Paclitaxel|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
11249838|NCT02551055|BG003|Baseline|MLN1117 600 mg + Paclitaxel|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
11249839|NCT02551055|BG004|Baseline|MLN1117 300 mg + TAK-659|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 [NCT02000934]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
11249840|NCT02551055|BG005|Baseline|MLN1117 200 mg + Docetaxel|MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
11249841|NCT02551055|BG006|Baseline|MLN1117 300 mg + Docetaxel|MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
11249842|NCT02551055|BG007|Baseline|Total|Total of all reporting groups
11249843|NCT02551055|FG000|Participant Flow|MLN1117 300 mg + Alisertib|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
10969797|NCT00907517|BG001|Baseline|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969798|NCT00907517|BG002|Baseline|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
11249844|NCT02551055|FG001|Participant Flow|MLN1117 600 mg + Alisertib|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
11249845|NCT02551055|FG002|Participant Flow|MLN1117 300 mg + Paclitaxel|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
11249846|NCT02551055|FG003|Participant Flow|MLN1117 600 mg + Paclitaxel|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
11249847|NCT02551055|FG004|Participant Flow|MLN1117 300 mg + TAK-659|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 [NCT02000934]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
11249848|NCT02551055|FG005|Participant Flow|MLN1117 200 mg + Docetaxel|MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
11249849|NCT02551055|FG006|Participant Flow|MLN1117 300 mg + Docetaxel|MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
11249850|NCT02551055|FG007|Participant Flow|Part 2|Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
11249851|NCT02551055|OG000|Outcome|MLN1117 300 mg + Alisertib|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
11249852|NCT02551055|OG001|Outcome|MLN1117 600 mg + Alisertib|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
11249853|NCT02551055|OG002|Outcome|MLN1117 300 mg + Paclitaxel|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
11249854|NCT02551055|OG003|Outcome|MLN1117 600 mg + Paclitaxel|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
11249855|NCT02551055|OG004|Outcome|MLN1117 300 mg + TAK-659|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 [NCT02000934]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
11249856|NCT02551055|OG005|Outcome|MLN1117 200 mg + Docetaxel|MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
11249857|NCT02551055|OG006|Outcome|MLN1117 300 mg + Docetaxel|MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
11249858|NCT02551055|OG000|Outcome|Part 2|Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
11249859|NCT02551055|OG007|Outcome|Part 2|Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
11249860|NCT02551055|EG000|Reported Event|MLN1117 300 mg + Alisertib|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
11249861|NCT02551055|EG001|Reported Event|MLN1117 600 mg + Alisertib|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
11249862|NCT02551055|EG002|Reported Event|MLN1117 300 mg + Paclitaxel|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
11249863|NCT02551055|EG003|Reported Event|MLN1117 600 mg + Paclitaxel|MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
11249864|NCT02551055|EG004|Reported Event|MLN1117 300 mg + TAK-659|MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 [NCT02000934]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
11249865|NCT02551055|EG005|Reported Event|MLN1117 200 mg + Docetaxel|MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
11249866|NCT02551055|EG006|Reported Event|MLN1117 300 mg + Docetaxel|MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
11249867|NCT02551094|BG000|Baseline|Colchicine|"0.5 mg tablet of colchicine taken once a day~colchicine: 0.5 mg tablet taken once a day"
11249868|NCT02551094|BG001|Baseline|Colchicine Placebo|"0.5 mg tablet of placebo taken once a day~colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet"
11249869|NCT02551094|BG002|Baseline|Total|Total of all reporting groups
11249870|NCT02551094|FG000|Participant Flow|Colchicine|"0.5 mg tablet of colchicine taken once a day~colchicine: 0.5 mg tablet taken once a day"
11249871|NCT02551094|FG001|Participant Flow|Colchicine Placebo|"0.5 mg tablet of placebo taken once a day~colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet"
11249872|NCT02551094|OG000|Outcome|Colchicine Placebo|"0.5 mg tablet of placebo taken once a day~colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet"
11249873|NCT02551094|OG001|Outcome|Colchicine|"0.5 mg tablet of colchicine taken once a day~colchicine: 0.5 mg tablet taken once a day"
11249874|NCT02551094|EG000|Reported Event|Colchicine Placebo|"0.5 mg tablet of placebo taken once a day~colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet"
11249875|NCT02551094|EG001|Reported Event|Colchicine|"0.5 mg tablet of colchicine taken once a day~colchicine: 0.5 mg tablet taken once a day"
11249876|NCT02551159|BG000|Baseline|Durvalumab + Tremelimumab|tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249877|NCT02551159|BG001|Baseline|Durvalumab|durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249878|NCT02551159|BG002|Baseline|Standard of Care (SOC)|either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
11249879|NCT02551159|BG003|Baseline|Total|Total of all reporting groups
11249880|NCT02551159|FG000|Participant Flow|Durvalumab + Tremelimumab|tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
10969799|NCT00907517|BG003|Baseline|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
11249881|NCT02551159|FG001|Participant Flow|Durvalumab|durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249882|NCT02551159|FG002|Participant Flow|Standard of Care (SOC)|either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
11249883|NCT02551159|OG000|Outcome|Durvalumab + Tremelimumab|tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249884|NCT02551159|OG001|Outcome|Durvalumab|durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249885|NCT02551159|OG002|Outcome|Standard of Care (SOC)|either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
11249886|NCT02551159|EG000|Reported Event|Durvalumab + Tremelimumab|tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249887|NCT02551159|EG001|Reported Event|Durvalumab|durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
11249888|NCT02551159|EG002|Reported Event|Standard of Care (SOC)|either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
11249889|NCT02551224|BG000|Baseline|Overall|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
11249890|NCT02551224|FG000|Participant Flow|Breezhaler, Then Ellipta group1|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires are administered after using each device.
11249891|NCT02551224|FG001|Participant Flow|Ellipta Then, Breezhaler Group 2|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires administered after using each device.
11249892|NCT02551224|OG000|Outcome|Breezhaler|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
11249893|NCT02551224|OG001|Outcome|Ellipta|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
11249894|NCT02551224|EG000|Reported Event|Breezhaler|Half of the patients will be assigned to first receive a single dose of placebo via the Breezhaler® followed by (minimum of 5 minutes) a single dose of placebo via the Ellipta® inhalation device. The evaluation questionnaires were administered after using each device.
11249895|NCT02551224|EG001|Reported Event|Ellipta|Half of the patients will be assigned to first receive a single dose of placebo via the Ellipta® followed by (minimum of 5 minutes) a single dose of placebo via the Breezhaler® inhalation device. The evaluation questionnaires were administered after using each device.
11249896|NCT02551432|BG000|Baseline|Paclitaxel Pembrolizumab|"PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous,~Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous,~Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity~pembrolizumab, paclitaxel: pembrolizumab, paclitaxel"
11249897|NCT02551432|FG000|Participant Flow|Paclitaxel Pembrolizumab|"PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous,~Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous,~Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity~pembrolizumab, paclitaxel: pembrolizumab, paclitaxel"
11249898|NCT02551432|OG000|Outcome|Paclitaxel Pembrolizumab|"PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous,~Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous,~Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity~pembrolizumab, paclitaxel: pembrolizumab, paclitaxel"
11249899|NCT02551432|EG000|Reported Event|Paclitaxel Pembrolizumab|"PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous,~Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous,~Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity~pembrolizumab, paclitaxel: pembrolizumab, paclitaxel"
11249900|NCT02551653|BG000|Baseline|PAH Participants|Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
11249901|NCT02551653|BG001|Baseline|Healthy Volunteers|Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
11249902|NCT02551653|BG002|Baseline|Total|Total of all reporting groups
11249903|NCT02551653|FG000|Participant Flow|PAH Participants|Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
11249904|NCT02551653|FG001|Participant Flow|Healthy Volunteers|Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
11249905|NCT02551653|OG000|Outcome|PAH Participants|Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
11249906|NCT02551653|OG001|Outcome|Healthy Volunteers|Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
11249907|NCT02551653|EG000|Reported Event|PAH Participants|Participants received one microdose that is (i.e.) less than 10 micrograms of radiolabeled GSK2256098 in a 20 milliliter (mL) volume, via intravenous (IV) route. A PET scan was performed immediately after the IV administration.
11249908|NCT02551653|EG001|Reported Event|Healthy Volunteers|Participants received one microdose i.e. less than 10 micrograms of radiolabeled GSK2256098 in a 20 mL volume, via IV route. A PET scan was performed immediately after the IV administration.
11249909|NCT02551666|BG000|Baseline|Tai Chi Exercise Intervention|"Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.~Tai Chi exercise: Participants will perform Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session will be led by an experienced Tai Chi instructor."
11249910|NCT02551666|BG001|Baseline|Balance Recovery Training|"Participants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.~Balance recovery training: Participants will practice recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions will last approximately 30 minutes, and will be performed 3 times per week for 4 weeks."
11249911|NCT02551666|BG002|Baseline|Total|Total of all reporting groups
11249912|NCT02551666|FG000|Participant Flow|Tai Chi Exercise|"Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.~Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor."
11249913|NCT02551666|FG001|Participant Flow|Balance Recovery Training|"Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.~Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks."
11249914|NCT02551666|OG000|Outcome|Tai Chi Exercise|"Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.~Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor."
11249915|NCT02551666|OG001|Outcome|Balance Recovery Training|"Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.~Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks."
11249916|NCT02551666|EG000|Reported Event|Tai Chi Exercise|"Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.~Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor."
11249917|NCT02551666|EG001|Reported Event|Balance Recovery Training|"Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.~Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks."
11249918|NCT02551692|BG000|Baseline|Placebo (PLAC)|"Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions."
11249919|NCT02551692|BG001|Baseline|Transdermal Nicotine Patch (NRT)|"Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
11249920|NCT02551692|BG002|Baseline|Varenicline (VAR)|"Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the VAR group, participants will wear a placebo patch while taking varenicline."
11249921|NCT02551692|BG003|Baseline|Total|Total of all reporting groups
11249922|NCT02551692|FG000|Participant Flow|Placebo (PLAC)|"Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions."
11249923|NCT02551692|FG001|Participant Flow|Transdermal Nicotine Patch (NRT)|"Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
11249924|NCT02551692|FG002|Participant Flow|Varenicline (VAR)|"Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the VAR group, participants will wear a placebo patch while taking varenicline."
11249925|NCT02551692|OG000|Outcome|Placebo (PLAC)|"Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions."
11249926|NCT02551692|OG001|Outcome|Transdermal Nicotine Patch (NRT)|"Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
11249927|NCT02551692|OG002|Outcome|Varenicline (VAR)|"Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the VAR group, participants will wear a placebo patch while taking varenicline."
10969800|NCT00907517|BG004|Baseline|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969801|NCT00907517|BG005|Baseline|Total|Total of all reporting groups
11249928|NCT02551692|EG000|Reported Event|Placebo (PLAC)|"Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions."
11249929|NCT02551692|EG001|Reported Event|Transdermal Nicotine Patch (NRT)|"Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
11249930|NCT02551692|EG002|Reported Event|Varenicline (VAR)|"Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the VAR group, participants will wear a placebo patch while taking varenicline."
11249931|NCT02551731|BG000|Baseline|Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID|The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
11249932|NCT02551731|FG000|Participant Flow|Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID|The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
11249933|NCT02551731|OG000|Outcome|Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID|The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
11249934|NCT02551731|EG000|Reported Event|Cannabidiol Oral Solution: 20-40 mg/kg/Day BID|The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
11249935|NCT02551744|BG000|Baseline|Proton Pump Inhibitor Group|"Pantoprazole Tab 40mg qd for 6 monthrs.~proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months."
11249936|NCT02551744|BG001|Baseline|Histamine-2 Receptor Antagonist Group|"famotidine Tab 40 mg qd for 6 months.~histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months."
11249937|NCT02551744|BG002|Baseline|Total|Total of all reporting groups
11249938|NCT02551744|FG000|Participant Flow|Proton Pump Inhibitor Group|"Pantoprazole Tab 40mg qd for 6 monthrs.~proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months."
11249939|NCT02551744|FG001|Participant Flow|Histamine-2 Receptor Antagonist Group|"famotidine Tab 40 mg qd for 6 months.~histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months."
11249940|NCT02551744|OG000|Outcome|Proton Pump Inhibitor Group|"Pantoprazole Tab 40mg qd for 6 monthrs.~proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months."
10969802|NCT00907517|FG000|Participant Flow|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969803|NCT00907517|FG001|Participant Flow|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969804|NCT00907517|FG002|Participant Flow|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969805|NCT00907517|FG003|Participant Flow|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969806|NCT00907517|FG004|Participant Flow|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969807|NCT00907517|OG000|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969808|NCT00907517|OG001|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969809|NCT00907517|OG002|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969810|NCT00907517|OG003|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969811|NCT00907517|OG004|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969812|NCT00907517|EG000|Reported Event|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969813|NCT00907517|EG001|Reported Event|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969814|NCT00907517|EG002|Reported Event|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
11249941|NCT02551744|OG001|Outcome|Histamine-2 Receptor Antagonist Group|"famotidine Tab 40 mg qd for 6 months.~histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months."
11249942|NCT02551744|EG000|Reported Event|Proton Pump Inhibitor Group|"Pantoprazole Tab 40mg qd for 6 monthrs.~proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months."
11249943|NCT02551744|EG001|Reported Event|Histamine-2 Receptor Antagonist Group|"famotidine Tab 40 mg qd for 6 months.~histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months."
11249944|NCT02551757|BG000|Baseline|Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admit to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve CPAP adherence for patients treated with active-CPAP included education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP."
11249945|NCT02551757|BG001|Baseline|Sham-CPAP|"The sham-CPAP device was designed to entail no risks beyond those with CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the mask, which creates a larger than standard air leak that delivers a pressure of roughly 0.75 to 1 cm water. The modification is not noticeable when the device is fully assembled to avoid unblinding patients, providers, or study personnel. The elbow modification could only be used on standard nasal masks so full face masks and nasal pillows were excluded for patients in both active and sham-CPAP.~Sham-CPAP was initiated after admission to rehabilitation for the duration of rehabilitation but not exceeding 28 days. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included education, desensitization of CPAP through brief periods of daytime use and adjustments of humidity and mask, including addition of a chin strap."
11249946|NCT02551757|BG002|Baseline|Total|Total of all reporting groups
11286378|NCT02887404|FG001|Participant Flow|Usual Care|"Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Usual Care: Standard of pain management care"
10969815|NCT00907517|EG003|Reported Event|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
10969816|NCT00907517|EG004|Reported Event|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
11249947|NCT02551757|FG000|Participant Flow|Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included patient education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for"
11249948|NCT02551757|FG001|Participant Flow|Sham-CPAP|"The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device is an auto-titrating CPAP with an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification creates a larger than standard air leak that serves to prevent any chances of carbon dioxide rebreathing and delivers a pressure at the mask interface of roughly 0.75 to 1 cm water. The elbow modification is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel. The elbow modification could only be used on standard nasal masks; consequently full facemasks and nasal pillows were excluded for patients in both active and sham-CPAP.~Sham-CPAP: Sham-CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly t"
11249949|NCT02551757|OG000|Outcome|Eligible Recruited Participants: Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine."
11249950|NCT02551757|OG001|Outcome|Eligible Recruited Participants: Sham-CPAP|"The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.~Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days."
11249951|NCT02551757|OG000|Outcome|Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days."
11249952|NCT02551757|OG001|Outcome|Sham-CPAP|"The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask interface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.~Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days."
11249953|NCT02551757|OG000|Outcome|Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included education, desensitization of CPAP through daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP."
11249954|NCT02551757|OG001|Outcome|Sham-CPAP|"The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.~Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. Respiratory therapist visited patients nightly to address issues arising at night. A sleep technologist also met with patients at least twice weekly to make any adjustments to the mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through daytime use and adjustments of humidity and mask."
11249955|NCT02551757|EG000|Reported Event|Active-CPAP|"Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.~Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included education, desensitization of CPAP through daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP."
11249956|NCT02551757|EG001|Reported Event|Sham-CPAP|"The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.~Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. Respiratory therapist visited patients nightly to address issues arising at night. A sleep technologist also met with patients at least twice weekly to make any adjustments to the mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through daytime use and adjustments of humidity and mask."
11249957|NCT02551770|BG000|Baseline|All Participants|"Participants assigned to receive both interventions (i.e., control and test) in different quadrants of the jaw.~- Test Treatment (Scaling and root planing with Emdogain): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.~Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.~- Control Treatment (Scaling and root planing): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) to treat one contra-lateral quadrant in subject's jaw."
11249958|NCT02551770|FG000|Participant Flow|Test (With Emdogain)|"Scaling and root planing with Emdogain~Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.~Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw"
11249959|NCT02551770|FG001|Participant Flow|Control (Without Emdogain)|"Scaling and root planing without Emdogain~Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw."
11249960|NCT02551770|OG000|Outcome|Test (With Emdogain)|"Scaling and root planing with Emdogain~Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.~Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw"
11249961|NCT02551770|OG001|Outcome|Control (Without Emdogain)|"Scaling and root planing without Emdogain~Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw."
11249962|NCT02551770|EG000|Reported Event|All Participants|All Participants
11249963|NCT02551809|BG000|Baseline|3 Priming Doses Followed by 4 Boosters|"Subjects will receive 7 doses of UB-311.~UB-311: Intramuscular injection"
11249964|NCT02551809|BG001|Baseline|3 Priming Doses Followed by 2 Boosters|"Subjects will receive 5 doses of UB-311 and 2 doses of placebo.~UB-311: Intramuscular injection~Placebo: Intramuscular injection"
11249965|NCT02551809|BG002|Baseline|Placebo|"Subjects will receive 7 doses of placebo.~Placebo: Intramuscular injection"
11249966|NCT02551809|BG003|Baseline|Total|Total of all reporting groups
11249967|NCT02551809|FG000|Participant Flow|3 Priming Doses Followed by 4 Boosters|"Subjects will receive 7 doses of UB-311.~UB-311: Intramuscular injection"
11249968|NCT02551809|FG001|Participant Flow|3 Priming Doses Followed by 2 Boosters|"Subjects will receive 5 doses of UB-311 and 2 doses of placebo.~UB-311: Intramuscular injection~Placebo: Intramuscular injection"
11249969|NCT02551809|FG002|Participant Flow|Placebo|"Subjects will receive 7 doses of placebo.~Placebo: Intramuscular injection"
11249970|NCT02551809|OG000|Outcome|3 Priming Doses Followed by 4 Boosters|"Subjects will receive 7 doses of UB-311.~UB-311: Intramuscular injection"
11249971|NCT02551809|OG001|Outcome|3 Priming Doses Followed by 2 Boosters|"Subjects will receive 5 doses of UB-311 and 2 doses of placebo.~UB-311: Intramuscular injection~Placebo: Intramuscular injection"
11249972|NCT02551809|OG002|Outcome|Placebo|"Subjects will receive 7 doses of placebo.~Placebo: Intramuscular injection"
11249973|NCT02551809|EG000|Reported Event|3 Priming Doses Followed by 4 Boosters|"Subjects will receive 7 doses of UB-311.~UB-311: Intramuscular injection"
11249974|NCT02551809|EG001|Reported Event|3 Priming Doses Followed by 2 Boosters|"Subjects will receive 5 doses of UB-311 and 2 doses of placebo.~UB-311: Intramuscular injection~Placebo: Intramuscular injection"
11249975|NCT02551809|EG002|Reported Event|Placebo|"Subjects will receive 7 doses of placebo.~Placebo: Intramuscular injection"
11249976|NCT02551822|BG000|Baseline|Group A (Cycling, Then Continuous)|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.~The first intervention (cycling) occurred at baseline, and the second intervention occurred at 3 months (continuous)."
11249977|NCT02551822|BG001|Baseline|Group B (Continuous, Then Cycling)|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.~The first intervention (continuous) occurred at baseline, and the second intervention occurred at 3 months (cycling)."
11249978|NCT02551822|BG002|Baseline|Total|Total of all reporting groups
11286379|NCT02887404|OG000|Outcome|Spine Surgery Analgesic Pathway|"Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Spine surgery analgesic pathway: Enhanced pain management care"
11249979|NCT02551822|FG000|Participant Flow|Cycling, Then Continuous|Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
11249980|NCT02551822|FG001|Participant Flow|Continuous, Then Cycling|Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
11249981|NCT02551822|OG000|Outcome|Cycling, Then Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
11249982|NCT02551822|OG001|Outcome|Continuous, Then Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
11249983|NCT02551822|EG000|Reported Event|Arm 1: Cycling|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a cycling program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
11249984|NCT02551822|EG001|Reported Event|Arm 2: Continuous|"Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a continuous program.~sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation."
11249985|NCT02551874|BG000|Baseline|Dapagliflozin + Saxagliptin + Metformin|"Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249986|NCT02551874|BG001|Baseline|Titrated Insulin + Metformin|"Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249987|NCT02551874|BG002|Baseline|Total|Total of all reporting groups
11249988|NCT02551874|FG000|Participant Flow|Dapagliflozin + Saxagliptin + Metformin|"Subjects received dapagliflozin 10 milligrams (mg) and saxagliptin 5 mg, administered orally once daily (QD) in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).~Subjects continued to receive their stable dose of metformin with or without sulfonylurea (SU) throughout the study."
11249989|NCT02551874|FG001|Participant Flow|Titrated Insulin + Metformin|"Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kilogram (kg) body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249990|NCT02551874|OG000|Outcome|Dapagliflozin + Saxagliptin + Metformin|"Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249991|NCT02551874|OG001|Outcome|Titrated Insulin + Metformin|"Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249992|NCT02551874|EG000|Reported Event|Dapagliflozin + Saxagliptin + Metformin|"Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249993|NCT02551874|EG001|Reported Event|Titrated Insulin + Metformin|"Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.~Subjects continued to receive their stable dose of metformin with or without SU throughout the study."
11249994|NCT02551887|BG000|Baseline|Usual Care|Non-interventional study arm. Patients receive usual care.
11249995|NCT02551887|BG001|Baseline|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
11249996|NCT02551887|BG002|Baseline|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
11249997|NCT02551887|BG003|Baseline|Total|Total of all reporting groups
11249998|NCT02551887|FG000|Participant Flow|Usual Care|Non-interventional study arm. Patients receive usual care.
11249999|NCT02551887|FG001|Participant Flow|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
11250000|NCT02551887|FG002|Participant Flow|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
11250001|NCT02551887|OG000|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
11250002|NCT02551887|OG001|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
11250003|NCT02551887|OG002|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
11250004|NCT02551887|EG000|Reported Event|Usual Care|Patients receive usual care.
11250005|NCT02551887|EG001|Reported Event|Automated Reminder|Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
11250006|NCT02551887|EG002|Reported Event|Automated Reminder Plus Recommended Script|In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
11250007|NCT02552121|BG000|Baseline|Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg|Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250008|NCT02552121|BG001|Baseline|Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg|Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250009|NCT02552121|BG002|Baseline|Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250010|NCT02552121|BG003|Baseline|Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250011|NCT02552121|BG004|Baseline|Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250012|NCT02552121|BG005|Baseline|Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250013|NCT02552121|BG006|Baseline|Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250014|NCT02552121|BG007|Baseline|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250015|NCT02552121|BG008|Baseline|Total|Total of all reporting groups
11250016|NCT02552121|FG000|Participant Flow|Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg|Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250017|NCT02552121|FG001|Participant Flow|Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg|Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250018|NCT02552121|FG002|Participant Flow|Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250019|NCT02552121|FG003|Participant Flow|Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250020|NCT02552121|FG004|Participant Flow|Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250021|NCT02552121|FG005|Participant Flow|Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250022|NCT02552121|FG006|Participant Flow|Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250023|NCT02552121|FG007|Participant Flow|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250024|NCT02552121|OG000|Outcome|Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg|Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250025|NCT02552121|OG001|Outcome|Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg|Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250026|NCT02552121|OG000|Outcome|Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250027|NCT02552121|OG001|Outcome|Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250028|NCT02552121|OG002|Outcome|Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250029|NCT02552121|OG003|Outcome|Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250030|NCT02552121|OG004|Outcome|Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250031|NCT02552121|OG005|Outcome|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250032|NCT02552121|OG004|Outcome|Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250033|NCT02552121|OG004|Outcome|Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk
11250034|NCT02552121|OG000|Outcome|Part 1: Dose Escalation: Cohort 1 3q4wk 0.9mg/kg|Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250035|NCT02552121|OG002|Outcome|Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250036|NCT02552121|OG003|Outcome|Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250037|NCT02552121|OG004|Outcome|Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250038|NCT02552121|OG005|Outcome|Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250039|NCT02552121|OG006|Outcome|Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250040|NCT02552121|OG007|Outcome|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250041|NCT02552121|OG005|Outcome|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk
11250042|NCT02552121|OG004|Outcome|Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
11250043|NCT02552121|OG005|Outcome|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
11250044|NCT02552121|OG001|Outcome|Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
11250045|NCT02552121|OG002|Outcome|Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
11250046|NCT02552121|EG000|Reported Event|Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg|Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250047|NCT02552121|EG001|Reported Event|Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg|Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
11250048|NCT02552121|EG002|Reported Event|Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250049|NCT02552121|EG003|Reported Event|Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
11250050|NCT02552121|EG004|Reported Event|Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
11250051|NCT02552121|EG005|Reported Event|Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
11250052|NCT02552121|EG006|Reported Event|Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian|Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250053|NCT02552121|EG007|Reported Event|Part 2: Cohort Expansion: Cohort 6 1q3w Cervical|Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
11250054|NCT02552147|BG000|Baseline|All Study Participants|Participants randomized to receive either transdermal nicotine or placebo
11250055|NCT02552147|FG000|Participant Flow|Transdermal Placebo First, Nicotine Last|"Subject will receive transdermal placebo daily for 7 days, placebo patch for another 7 days, then transdermal nicotine 7 mg daily for a final 7 days.~Transdermal nicotine~Transdermal placebo"
11250056|NCT02552147|FG001|Participant Flow|Transdermal Nicotine First, Placebo Last|"Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.~Transdermal nicotine~Transdermal placebo"
11250057|NCT02552147|OG000|Outcome|Nicotine|Subject receiving transdermal nicotine in either the first or last week of the study and completing all study visits.
11250058|NCT02552147|OG001|Outcome|Placebo|Subject receiving transdermal placebo in either the first or last week of the study and completing all study visits.
11250059|NCT02552147|EG000|Reported Event|Nicotine|Subject receiving transdermal nicotine in either the first or last week of the study and completing all study visits.
11250060|NCT02552147|EG001|Reported Event|Placebo|Subject receiving transdermal placebo in either the first or last week of the study and completing all study visits.
11250061|NCT02552225|BG000|Baseline|Amitriptyline|"Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)~Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)"
11250062|NCT02552225|BG001|Baseline|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)"
11250063|NCT02552225|BG002|Baseline|Total|Total of all reporting groups
11250064|NCT02552225|FG000|Participant Flow|Amitriptyline|"Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)~Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)"
11250065|NCT02552225|FG001|Participant Flow|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)"
11250066|NCT02552225|OG000|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)~Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)"
11250067|NCT02552225|OG001|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)"
11250068|NCT02552225|EG000|Reported Event|Amitriptyline|"Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)~Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)"
11250069|NCT02552225|EG001|Reported Event|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)"
11250070|NCT02552238|BG000|Baseline|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11250071|NCT02552238|FG000|Participant Flow|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11250072|NCT02552238|OG000|Outcome|CE-DSE - UE-DSE|Difference between CE-DSE and UE-DSE (CE-DSE - UE-DSE)
11250073|NCT02552238|OG000|Outcome|Reader 1|Reader 1 CE-DSE
11250074|NCT02552238|OG001|Outcome|Reader 2|Reader 2 CE-DSE
11250075|NCT02552238|OG002|Outcome|Reader 3|Reader 3 CE-DSE
11250076|NCT02552238|OG000|Outcome|UE-DSE|Unenhanced Stress Echocardiography
11250077|NCT02552238|OG001|Outcome|CE-DSE|Contrast-enhanced Stress Echocardiography
11250078|NCT02552238|OG002|Outcome|Difference|CE-DSE - UE-DSE
11250079|NCT02552238|OG000|Outcome|Lumason|All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography.
11250080|NCT02552238|EG000|Reported Event|Lumason|"Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection~Lumason: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography"
11250081|NCT02552303|BG000|Baseline|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
11250082|NCT02552303|BG001|Baseline|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
11250083|NCT02552303|BG002|Baseline|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
11250084|NCT02552303|BG003|Baseline|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
11250085|NCT02552303|BG004|Baseline|Total|Total of all reporting groups
11250086|NCT02552303|FG000|Participant Flow|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
11250087|NCT02552303|FG001|Participant Flow|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
11250088|NCT02552303|FG002|Participant Flow|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
11250089|NCT02552303|FG003|Participant Flow|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
11250090|NCT02552303|OG000|Outcome|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
11250091|NCT02552303|OG001|Outcome|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
11250092|NCT02552303|OG002|Outcome|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
11250093|NCT02552303|OG003|Outcome|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
11250094|NCT02552303|EG000|Reported Event|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Armodafinil: Active medication"
11250095|NCT02552303|EG001|Reported Event|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication~Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.~Placebo: Placebo for Nuvigil (armodafinil)"
11250096|NCT02552303|EG002|Reported Event|Armodafinil|"Medication (armodafinil) only, without CBTI.~Armodafinil: Active medication"
11250097|NCT02552303|EG003|Reported Event|Placebo|"Placebo only, without CBTI.~Placebo: Placebo for Nuvigil (armodafinil)"
11215571|NCT02300129|FG003|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
11215572|NCT02300129|OG000|Outcome|Period 2 CD07805/47 0.5% Gel Cross-over|CD07805/47 0.5% gel (Brimonidine tartrate)
11215573|NCT02300129|OG001|Outcome|Period 2 Placebo Gel Cross-over|CD07805/47 placebo gel
11215574|NCT02300129|EG000|Reported Event|Period 1 Placebo Gel Cross Over|Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
11215575|NCT02300129|EG001|Reported Event|Period 1 CD07805/47 0.5% Gel Split Face|Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
11215576|NCT02300129|EG002|Reported Event|Period 1 Placebo Gel Split Face|Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
11215577|NCT02300129|EG003|Reported Event|Period 1 CD07805/47 0.5% Gel Cross-over|Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
11215578|NCT02300129|EG004|Reported Event|Period 2 CD07805/47 0.5% Gel Cross Over|Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
11215579|NCT02300129|EG005|Reported Event|Period 2 Placebo Gel Cross Over|Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
11215580|NCT02300220|BG000|Baseline|Ciprofloxacin|"500 mg, twice daily for 1 week (oral).~Ciprofloxacin: 500 mg, twice daily for 1 week (oral)"
11215581|NCT02300220|BG001|Baseline|Placebo|"one capsule, twice daily for 1 week.~Placebo: One capsule, twice daily for 1 week"
11215582|NCT02300220|BG002|Baseline|Total|Total of all reporting groups
11215583|NCT02300220|FG000|Participant Flow|Ciproflaxacin|Retreatment with Ciproflaxacin
11215584|NCT02300220|FG001|Participant Flow|Placebo|Retreatment with Placebo
11215585|NCT02300220|OG000|Outcome|Ciprofloxacin|"500 mg, twice daily for 1 week (oral).~Ciprofloxacin: 500 mg, twice daily for 1 week (oral)"
11215586|NCT02300220|OG001|Outcome|Placebo|"one capsule, twice daily for 1 week.~Placebo: One capsule, twice daily for 1 week"
11215587|NCT02300220|EG000|Reported Event|Ciprofloxacin|"500 mg, twice daily for 1 week (oral).~Ciprofloxacin: 500 mg, twice daily for 1 week (oral)"
11215588|NCT02300220|EG001|Reported Event|Placebo|"one capsule, twice daily for 1 week.~Placebo: One capsule, twice daily for 1 week"
11215589|NCT02300259|BG000|Baseline|LY2623091 + Itraconazole (Group 1)|"Period 1: Single oral dose of 6 mg LY2623091 on Day 1.~Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6."
11215590|NCT02300259|BG001|Baseline|Simvastatin + LY2623091 (Group 2)|Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
11215591|NCT02300259|BG002|Baseline|LY2623091 + Diltiazem (Group 4)|"Period 1: Single oral dose of 6 mg LY2623091 on Day 1.~Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4."
11215592|NCT02300259|BG003|Baseline|Total|Total of all reporting groups
11215593|NCT02300259|FG000|Participant Flow|LY2623091 + Itraconazole (Group 1)|"Period 1: Single oral dose of 6 mg LY2623091 on Day 1.~Period 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6."
11215594|NCT02300259|FG001|Participant Flow|Simvastatin + LY2623091 (Group 2)|Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
11215595|NCT02300259|FG002|Participant Flow|LY2623091 + Diltiazem (Group 4)|"Period 1: Single oral dose of 6 mg LY2623091 on Day 1.~Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4."
11215596|NCT02300259|OG000|Outcome|LY2623091 (Group 1)|Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
11215597|NCT02300259|OG001|Outcome|Itraconazole + LY2623091 (Group 1)|Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
11215598|NCT02300259|OG002|Outcome|LY2623091 (Group 4)|"Period 1: Single oral dose of 6 mg LY2623091 on Day 1.~."
11215599|NCT02300259|OG003|Outcome|Diltiazem + LY2623091 (Group 4)|Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
11215600|NCT02300259|OG002|Outcome|LY2623091 (Group 4)|Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
11215601|NCT02300259|OG000|Outcome|Simvastatin (Group 2)|Single oral dose of 20 mg simvastatin on Day 1.
11215602|NCT02300259|OG001|Outcome|LY2623091 + Simvastatin (Group 2)|Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
11215603|NCT02300259|OG001|Outcome|LY2623091 + Simvastatin|Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
11215604|NCT02300259|EG000|Reported Event|LY2623091 (Group 1)|Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
11215605|NCT02300259|EG001|Reported Event|Itraconazole (Group 1)|Period 2: Oral doses of 200 mg itraconazole BID on Days 1 through 5.
11215606|NCT02300259|EG002|Reported Event|Itraconazole + LY2623091 (Group 1)|Period 2: Oral doses of 200 mg itraconazole and 6 mg LY2623091 coadministered once on Day 6.
11215607|NCT02300259|EG003|Reported Event|Simvastatin (Group 2)|Single oral dose of 20 mg simvastatin on Day 1.
11215608|NCT02300259|EG004|Reported Event|LY2623091 (Group 2)|Oral doses of 24.5 mg LY2623091 QD on Days 3 to 11.
11215609|NCT02300259|EG005|Reported Event|LY2623091 + Simvastatin (Group 2)|Oral doses of 24.5 mg LY2623091 and 20 mg simvastatin coadministered once on Day 12.
11215610|NCT02300259|EG006|Reported Event|LY2623091 (Group 4)|Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
11215611|NCT02300259|EG007|Reported Event|Diltiazem (Group 4)|Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 through 3.
11250098|NCT02552316|BG000|Baseline|NB-UVB Phototherapy|"NB-UVB phototherapy is a therapy which uses ultraviolet B (UVB) light directed at the skin. This type of light therapy is given through the use of phototherapy booths which contain fluorescent tubes that emit UVB light. Booths used for phototherapy look similar to commercial tanning booths. NB-UVB phototherapy affects psoriasis by causing changes to the cells of the skin and producing a local effect by reducing the number of certain types of skin cells which have an impact on psoriasis formation.~NB-UVB Phototherapy"
11250099|NCT02552316|FG000|Participant Flow|NB-UVB Phototherapy|"Narrow band-UVB (NB-UVB) phototherapy is a therapy which uses ultraviolet B (UVB) light directed at the skin. This type of light therapy is given through the use of phototherapy booths which contain fluorescent tubes that emit UVB light. Booths used for phototherapy look similar to commercial tanning booths. NB-UVB phototherapy affects psoriasis by causing changes to the cells of the skin and producing a local effect by reducing the number of certain types of skin cells which have an impact on psoriasis formation.~In the study, NB-UVB phototherapy administered 3 times per week for 8 weeks."
11250100|NCT02552316|OG000|Outcome|Group 1a- Plaque Center vs Plaque Edge|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center vs plaque edge."
11250101|NCT02552316|OG001|Outcome|Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center vs ipsilateral perilesional unaffected skin"
11250102|NCT02552316|OG002|Outcome|Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center vs ipsilateral distant unaffected skin."
11250103|NCT02552316|OG003|Outcome|Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy.~Difference in the measure of Shannon diversity index between perilesional ipsilateral unaffected skin vs distant ipsilateral unaffected skin."
11250104|NCT02552316|OG004|Outcome|Group 1e- Plaque Center vs Contralateral Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center vs contralateral unaffected skin."
11250105|NCT02552316|OG000|Outcome|Group 2a- Plaque Center|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center at baseline vs week 8."
11250106|NCT02552316|OG001|Outcome|Group 2b- Ipsilateral Distant Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between ipsilateral distant unaffected skin at baseline vs week 8."
11250107|NCT02552316|OG002|Outcome|Group 2c- Contralateral Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between contralateral unaffected skin at baseline vs week 8."
11250108|NCT02552316|OG003|Outcome|Group 2d- Unaffected Back Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between unaffected back skin at baseline vs week 8."
11250109|NCT02552316|OG000|Outcome|Group 3a- Plaque Center|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between plaque center at baseline vs week 9."
11250110|NCT02552316|OG001|Outcome|Group 3b- Ipsilateral Distant Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between ipsilateral distant unaffected skin at baseline vs week 9."
11250111|NCT02552316|OG002|Outcome|Group 3c- Contralateral Unaffected Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between contralateral unaffected skin at baseline vs week 9."
11250112|NCT02552316|OG003|Outcome|Group 3d- Unaffected Back Skin|"The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Difference in the measure of Shannon diversity index between unaffected back skin at baseline vs week 9."
11250113|NCT02552316|OG000|Outcome|Group 1|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between plaque edge vs plaque center and ipsilateral perilesional unaffected skin vs plaque center at baseline."
11250114|NCT02552316|OG001|Outcome|Group 2|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between plaque edge vs plaque center and ipsilateral distant unaffected skin vs plaque center at baseline."
11250115|NCT02552316|OG002|Outcome|Group 3|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between plaque edge vs plaque center and contralateral unaffected skin vs plaque center at baseline."
11250116|NCT02552316|OG003|Outcome|Group 4|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between Ipsilateral perilesional unaffected skin vs plaque center and ipsilateral distant unaffected skin vs plaque center at baseline."
11250117|NCT02552316|OG004|Outcome|Group 5|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between Ipsilateral perilesional unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline."
11250118|NCT02552316|OG005|Outcome|Group 6|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.~Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline."
11250119|NCT02552316|OG000|Outcome|Plaque Edge vs Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Comparison of differences in mean between plaque edge vs plaque center at baseline vs plaque edge vs plaque center at week 8."
11250120|NCT02552316|OG001|Outcome|Ipsilateral Perilesional Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Comparison of differences in mean between Ipsilateral perilesional unaffected skin vs plaque center at baseline vs Ipsilateral perilesional unaffected skin vs plaque center at week 8."
11250121|NCT02552316|OG002|Outcome|Ipsilateral Distant Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center at baseline vs Ipsilateral distant unaffected skin vs plaque center at week 8."
11250122|NCT02552316|OG003|Outcome|Contralateral Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Comparison of differences in mean between contralateral unaffected skin vs plaque center at baseline vs contralateral unaffected skin vs plaque center at week 8."
11250123|NCT02552316|OG004|Outcome|Unaffected Back vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 8 after initiation of phototherapy.~Comparison of differences in mean between unaffected back vs plaque center at baseline vs unaffected back vs plaque center at week 8."
11250124|NCT02552316|OG000|Outcome|Plaque Edge vs Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Comparison of differences in mean between plaque edge vs plaque center at baseline vs plaque edge vs plaque center at week 9."
11250125|NCT02552316|OG001|Outcome|Ipsilateral Perilesional Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Comparison of differences in mean between Ipsilateral perilesional unaffected skin vs plaque center at baseline vs Ipsilateral perilesional unaffected skin vs plaque center at week 9."
11250126|NCT02552316|OG002|Outcome|Ipsilateral Distant Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center at baseline vs Ipsilateral distant unaffected skin vs plaque center at week 9."
11250127|NCT02552316|OG003|Outcome|Contralateral Unaffected Skin vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Comparison of differences in mean between contralateral unaffected skin vs plaque center at baseline vs contralateral unaffected skin vs plaque center at week 9."
11250128|NCT02552316|OG004|Outcome|Unaffected Back vs Plaque Center|"The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy and week 9 after initiation of phototherapy.~Comparison of differences in mean between unaffected back vs plaque center at baseline vs unaffected back vs plaque center at week 9."
11250129|NCT02552316|OG000|Outcome|Plaque Edge vs Center|"Bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy.~Comparison between plaque edge vs plaque center at baseline."
11250130|NCT02552316|OG001|Outcome|Ipsilateral Perilesional Unaffected Skin vs Plaque Center|"Bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy.~Comparison between Ipsilateral perilesional unaffected skin vs plaque center at baseline."
11250131|NCT02552316|OG002|Outcome|Ipsilateral Distant Unaffected Skin vs Plaque Center|"Bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy.~Comparison between Ipsilateral distant unaffected skin vs plaque center at baseline."
11250132|NCT02552316|OG003|Outcome|Contralateral Unaffected Skin vs Plaque Center|"Bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy.~Comparison between contralateral unaffected skin vs plaque center at baseline."
11250133|NCT02552316|OG000|Outcome|Plaque Center|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between plaque center at baseline vs plaque center at week 8."
11250134|NCT02552316|OG001|Outcome|Plaque Edge|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between plaque edge at baseline vs plaque edge at week 8."
11250135|NCT02552316|OG002|Outcome|Ipsilateral Perilesional Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between ipsilateral perilesional unaffected skin at baseline vs ipsilateral perilesional unaffected skin at week 8."
11250136|NCT02552316|OG003|Outcome|Ipsilateral Distant Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between ipsilateral distant unaffected skin at baseline vs ipsilateral distant unaffected skin at week 8."
11250137|NCT02552316|OG004|Outcome|Contralateral Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between contralateral unaffected skin at baseline vs contralateral unaffected skin week 8."
11250138|NCT02552316|OG005|Outcome|Unaffected Back|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 8 after the initiation of phototherapy.~Comparison between unaffected back at baseline vs unaffected back week 8."
11250139|NCT02552316|OG000|Outcome|Plaque Center|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between plaque center at baseline vs plaque center at week 9."
11250140|NCT02552316|OG001|Outcome|Plaque Edge|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between plaque edge at baseline vs plaque edge at week 9."
11250141|NCT02552316|OG002|Outcome|Ipsilateral Perilesional Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between ipsilateral perilesional unaffected skin at baseline vs ipsilateral perilesional unaffected skin at week 9."
11250142|NCT02552316|OG003|Outcome|Ipsilateral Distant Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between ipsilateral distant unaffected skin at baseline vs ipsilateral distant unaffected skin at week 9."
11250143|NCT02552316|OG004|Outcome|Contralateral Unaffected Skin|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between contralateral unaffected skin at baseline vs contralateral unaffected skin week 9."
11250144|NCT02552316|OG005|Outcome|Unaffected Back|"Change in bacterial load in a given sample using log10 (bacterial count/ sample) units at baseline prior to initiation of phototherapy and at week 9 after the initiation of phototherapy.~Comparison between unaffected back at baseline vs unaffected back week 9."
11250145|NCT02552316|EG000|Reported Event|NB-UVB Phototherapy|"NB-UVB phototherapy is a therapy which uses ultraviolet B (UVB) light directed at the skin. This type of light therapy is given through the use of phototherapy booths which contain fluorescent tubes that emit UVB light. Booths used for phototherapy look similar to commercial tanning booths. NB-UVB phototherapy affects psoriasis by causing changes to the cells of the skin and producing a local effect by reducing the number of certain types of skin cells which have an impact on psoriasis formation.~NB-UVB Phototherapy"
11250146|NCT02552355|BG000|Baseline|Metformin: Carbohydrate|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training. Immediately after each exercise session, participants consumed a standardized beverage that consisted of carbohydrates (82g) plus protein (2g).~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250147|NCT02552355|BG001|Baseline|Placebo: Carbohydrate|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Immediately after each exercise session, participants consumed a standardized beverage that consisted of carbohydrates (82g) plus protein (2g)."
11250148|NCT02552355|BG002|Baseline|Metformin: Protein|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training. Immediately after each exercise session, participants consumed a standardized beverage that consisted of carbohydrate (63g) plus protein (20g).~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250149|NCT02552355|BG003|Baseline|Placebo: Protein|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Immediately after each exercise session, participants consumed a standardized beverage that consisted of carbohydrates (63 g) plus protein (20g)."
10969817|NCT00907621|BG000|Baseline|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
11250150|NCT02552355|BG004|Baseline|Total|Total of all reporting groups
11250151|NCT02552355|FG000|Participant Flow|Metformin:Carbohydrate|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a isocaloric carbohydrate beverage.~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250152|NCT02552355|FG001|Participant Flow|Placebo:Carbohydrate|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of with post-exercise consumption of a protein beverage. The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Placebo: Daily administration of matching placebo during a 12 week exercise training program."
11250153|NCT02552355|FG002|Participant Flow|Metformin:Protein|Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a protein beverage. The dose of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4.
11250154|NCT02552355|FG003|Participant Flow|Placebo: Carbohydrate|Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a isocaloric carbohydrate beverage. The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.
11250155|NCT02552355|OG000|Outcome|Metformin: Carbohydrate|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a carbohydrate beverage.~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250156|NCT02552355|OG001|Outcome|Placebo:Carbohydrate|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Placebo: Daily administration of matching placebo during a 12 week exercise training program with post-exercise consumption of a carbohydrate beverage."
11250157|NCT02552355|OG002|Outcome|Metformin: Protein|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a protein beverage.~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250158|NCT02552355|OG003|Outcome|Placebo: Protein|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Placebo: Daily administration of matching placebo during a 12 week exercise training program with post-exercise consumption of a protein beverage."
11250159|NCT02552355|EG000|Reported Event|Metformin: Carbohydrate|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a isocaloric carbohydrate beverage.~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250160|NCT02552355|EG001|Reported Event|Placebo: Carbohydrate|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Placebo: Daily administration of matching placebo during a 12 week exercise training program with post-exercise consumption of an isocaloric carbohydrate beverage."
11250161|NCT02552355|EG002|Reported Event|Metformin: Protein|"Daily oral administration of Metformin with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training with post-exercise consumption of a protein beverage.~Metformin: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program."
11250162|NCT02552355|EG003|Reported Event|Placebo:Protein|"Daily oral administration of matching placebo with a 12-week exercise training program consisting of 3 days per week of aerobic exercise training The dose of matching placebo will begin as one tablet for the first week and will increase by one tablet/day/week until reaching 4 tablets by week 4.~Placebo: Daily administration of matching placebo during a 12 week exercise training program with post-exercise consumption of a protein beverage."
11250163|NCT02552368|BG000|Baseline|Experimental|"IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.~IpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity."
11250164|NCT02552368|FG000|Participant Flow|IpsiHand|"IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.~IpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity."
10969818|NCT00907621|BG001|Baseline|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
11250165|NCT02552368|OG000|Outcome|Change in ARAT From Baseline to 12 Weeks of BCI Device Use|IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.
10969819|NCT00907621|BG002|Baseline|Total|Total of all reporting groups
11215612|NCT02300259|EG008|Reported Event|Diltiazem + LY2623091 (Group 4)|Period 2: Oral doses of 240 mg diltiazem extended release and 6 mg LY2623091 coadministered once on Day 4.
11215613|NCT02300285|BG000|Baseline|CGM Protocol|"Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment."
11215614|NCT02300285|BG001|Baseline|Standard of Care|"Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia."
11215615|NCT02300285|BG002|Baseline|Total|Total of all reporting groups
11215616|NCT02300285|FG000|Participant Flow|CGM Protocol|"Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment."
11215617|NCT02300285|FG001|Participant Flow|Standard of Care|"Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia."
11215618|NCT02300285|OG000|Outcome|CGM Protocol|"Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment."
11215619|NCT02300285|OG001|Outcome|Standard of Care|"Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia."
11215620|NCT02300285|EG000|Reported Event|CGM Protocol|"Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment."
11215621|NCT02300285|EG001|Reported Event|Standard of Care|"Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.~Continuous Glucose Monitoring: Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia."
11215622|NCT02300298|BG000|Baseline|Nintedanib Plus Docetaxel|The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
11215623|NCT02300298|FG000|Participant Flow|Nintedanib Plus Docetaxel (Patient Disposition for Nintedanib)|"The patient received 2*100 milligram (mg) twice daily (b.i.d.) of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.~Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again."
11250166|NCT02552368|OG000|Outcome|Change in COPM From Baseline to 12 Weeks of BCI Device Use|Ipsihand is a device that includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.
11250167|NCT02552368|EG000|Reported Event|Chronic Stroke Survivors|All adverse events were monitored throughout the study completion, an average of 2 years with no events reported.
11250168|NCT02552732|BG000|Baseline|NHF With or Without Oxygen|"NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge~NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C."
11250169|NCT02552732|FG000|Participant Flow|NHF With or Without Oxygen|"Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.~NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.~NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C."
11250170|NCT02552732|OG000|Outcome|NHF With or Without Oxygen|"Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.~NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.~NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C."
11250171|NCT02552732|OG000|Outcome|NHF With or Without Oxygen|"NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge~NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C."
11250172|NCT02552732|EG000|Reported Event|NHF With or Without Oxygen|"NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge~NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C."
11250173|NCT02552810|BG000|Baseline|Test Group|Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
11250174|NCT02552810|BG001|Baseline|Control Group|Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
11250175|NCT02552810|BG002|Baseline|Total|Total of all reporting groups
11250176|NCT02552810|FG000|Participant Flow|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
11250177|NCT02552810|FG001|Participant Flow|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
11250178|NCT02552810|OG000|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
11250179|NCT02552810|OG001|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
11250180|NCT02552810|EG000|Reported Event|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
11250181|NCT02552810|EG001|Reported Event|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
11250182|NCT02552888|BG000|Baseline|Treatment|"Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day.~Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day~Isoquercetin: Isoquercetin 225 mg by mouth once per day"
11250183|NCT02552888|BG001|Baseline|Placebos|"identical placebos.~placebos: placebos"
11250184|NCT02552888|BG002|Baseline|Total|Total of all reporting groups
11250185|NCT02552888|FG000|Participant Flow|Treatment|"Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day.~Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day~Isoquercetin: Isoquercetin 225 mg by mouth once per day"
11250186|NCT02552888|FG001|Participant Flow|Placebos|"identical placebos.~placebos: placebos"
11250187|NCT02552888|OG000|Outcome|Treatment|"Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day.~Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day~Isoquercetin: Isoquercetin 225 mg by mouth once per day"
11250188|NCT02552888|OG001|Outcome|Placebos|"identical placebos.~placebos: placebos"
11250189|NCT02552888|OG000|Outcome|Treatment|Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg once daily
11250190|NCT02552888|OG001|Outcome|Placebo|identical placebos
11250191|NCT02552888|OG000|Outcome|Treatment|Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once daily
11250192|NCT02552888|OG001|Outcome|Placebo|Identical Placebos
11250193|NCT02552888|EG000|Reported Event|Treatment|"Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day.~Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day~Isoquercetin: Isoquercetin 225 mg by mouth once per day"
11250194|NCT02552888|EG001|Reported Event|Placebos|"identical placebos.~placebos: placebos"
11250195|NCT02552966|BG000|Baseline|UESAD|"Upper Esophageal Sphincter Assist Device~UESAD: Device designed to provide modest cricoid pressure to reduce reflux"
11250196|NCT02552966|FG000|Participant Flow|UESAD|"Upper Esophageal Sphincter Assist Device~UESAD: Device designed to provide modest cricoid pressure to reduce reflux"
11250197|NCT02552966|OG000|Outcome|UESAD|"Upper Esophageal Sphincter Assist Device~UESAD: Device designed to provide modest cricoid pressure to reduce reflux"
11250198|NCT02552966|EG000|Reported Event|UESAD|"Upper Esophageal Sphincter Assist Device~UESAD: Device designed to provide modest cricoid pressure to reduce reflux"
11250199|NCT02553135|BG000|Baseline|Injection of AAV2-REP1|"Injection of AAV-REP1, 1.00x10e11 vg, subretinal injection of total volume of 100 μL.~Injection of AAV2-REP1 (10e11 vg): Single Group: single arm study"
11250200|NCT02553135|FG000|Participant Flow|Injection of AAV2-REP1|"Injection of AAV-REP1, 1.00x10e11 vg, subretinal injection of total volume of 100 μL.~Injection of AAV2-REP1 (10e11 vg): Single Group: single arm study"
11250201|NCT02553135|OG000|Outcome|Injection of AAV2-REP1|"Injection of AAV-REP1, 1.00x10e11 vg, subretinal injection of total volume of 100 μL.~Injection of AAV2-REP1 (10e11 vg): Single Group: single arm study"
11250202|NCT02553135|EG000|Reported Event|Injection of AAV2-REP1|"Injection of AAV-REP1, 1.00x10e11 vg, subretinal injection of total volume of 100 μL.~Injection of AAV2-REP1 (10e11 vg): Single Group: single arm study"
11250203|NCT02553317|BG000|Baseline|Caplacizumab|"Caplacizumab 10 mg once daily~Caplacizumab:~First day of treatment: 10 mg intravenous (i.v.) injection prior to PE followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.~Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.~Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
11250204|NCT02553317|BG001|Baseline|Placebo|"Placebo once daily~Placebo:~First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.~Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.~Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
11250205|NCT02553317|BG002|Baseline|Total|Total of all reporting groups
11250206|NCT02553317|FG000|Participant Flow|Caplacizumab|"Caplacizumab 10 mg once daily~Caplacizumab:~First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.~Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.~Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
11250207|NCT02553317|FG001|Participant Flow|Placebo|"Placebo once daily~Placebo:~First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.~Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.~Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
11250208|NCT02553317|OG000|Outcome|Caplacizumab|Caplacizumab 10 mg once daily
11250209|NCT02553317|OG001|Outcome|Placebo|Placebo once daily
11250210|NCT02553317|EG000|Reported Event|Double-blind Caplacizumab|Caplacizumab 10 mg once daily
11250211|NCT02553317|EG001|Reported Event|Double-blind Placebo|Placebo once daily
11250212|NCT02553317|EG002|Reported Event|Open-label Caplacizumab|In case an exacerbation during the 30-day treatment period or a relapse during the treatment extension period occurred (first exacerbation or relapse), subjects were to receive open label caplacizumab 10 mg daily together with re-initiation of daily PE and optimized immunosuppressive treatment. Caplacizumab treatment schedule and visit schedule were the same as for the initial study drug treatment period (covering daily PE [variable duration] and 30-day post-daily PE period) and the possible treatment extension period.
11250213|NCT02553330|BG000|Baseline|Part A: Ruxolitinib Cream|Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
11250214|NCT02553330|BG001|Baseline|Part B : Placebo Cream|Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
11250215|NCT02553330|BG002|Baseline|Part B : Ruxolitinib Cream|Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
11250216|NCT02553330|BG003|Baseline|Total|Total of all reporting groups
11250217|NCT02553330|FG000|Participant Flow|Part A: Ruxolitinib Cream|Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
11250218|NCT02553330|FG001|Participant Flow|Part B : Placebo Cream|Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
11250219|NCT02553330|FG002|Participant Flow|Part B : Ruxolitinib Cream|Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
11250220|NCT02553330|OG000|Outcome|Part A: Ruxolitinib Cream|Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
11250221|NCT02553330|OG000|Outcome|Part B : Placebo Cream|Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
11250222|NCT02553330|OG001|Outcome|Part B: Ruxolitinib Cream|Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
11250223|NCT02553330|OG001|Outcome|Part B : Ruxolitinib Cream|Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
11250224|NCT02553330|OG001|Outcome|Part B : Placebo Cream|Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks.
11250225|NCT02553330|OG002|Outcome|Part B : Ruxolitinib Cream|Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
11250226|NCT02553330|OG000|Outcome|Part B : Placebo Cream|Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks.
11250227|NCT02553330|EG000|Reported Event|Placebo Cream|Part B: Double-blind treatment for 24 weeks.
11250228|NCT02553330|EG001|Reported Event|Ruxolitinib Cream|"Part A: Open-label treatment for 24 weeks. Part B: Double-blind treatment for 24 weeks. Placebo group from Part B had the option to crossover after the first 24 weeks of treatment period.~Both Part A and Part B participants, if eligible, continued on to open-label extension (24 weeks) and long-term extension (48 weeks) periods."
11250229|NCT02553395|BG000|Baseline|Overall Study|Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.
11250230|NCT02553395|FG000|Participant Flow|Phenacite Contact Lens Then Comfilcon A|"Subjects were randomized to wear test lenses for one week and then cross-over to comfilcon A contact lens for one week.~Phenacite : Contact Lens comfilcon A: contact lens"
11250231|NCT02553395|FG001|Participant Flow|Comfilcon A Contact Lens Then Phenacite Contact Lens|"Subjects were randomized to wear comfilcon A lenses for one week and then cross-over to test contact lens for one week.~comfilcon A: contact lens Phenacite : Contact Lens"
11250232|NCT02553395|OG000|Outcome|Phenacite Contact Lens|"Subjects were randomized to wear test contact lens for one week.~Phenacite: Contact lens"
11250233|NCT02553395|OG001|Outcome|Comfilcon A Contact Lens|"Subjects were randomized to wear control contact lens for one week.~comfilcon A: contact lens"
11250234|NCT02553395|OG000|Outcome|Overall Study|Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.
11250235|NCT02553395|EG000|Reported Event|Phenacite Contact Lens|"Subjects were randomized to wear test contact lens for one week.~Phenacite: Contact lens"
11250236|NCT02553395|EG001|Reported Event|Comfilcon A Contact Lens|"Subjects were randomized to wear control contact lens for one week.~comfilcon A: contact lens"
11250237|NCT02553421|BG000|Baseline|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
11250238|NCT02553421|BG001|Baseline|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
11250239|NCT02553421|BG002|Baseline|Total|Total of all reporting groups
11250240|NCT02553421|FG000|Participant Flow|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
11250241|NCT02553421|FG001|Participant Flow|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
11250242|NCT02553421|OG000|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
11250243|NCT02553421|OG001|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
11250244|NCT02553421|OG000|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
11250245|NCT02553421|EG000|Reported Event|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
11250246|NCT02553421|EG001|Reported Event|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
11250247|NCT02553499|BG000|Baseline|MK-1248 0.12 mg|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250248|NCT02553499|BG001|Baseline|MK-1248 0.6 mg|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250249|NCT02553499|BG002|Baseline|MK-1248 3 mg|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250250|NCT02553499|BG003|Baseline|MK-1248 10 mg|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250251|NCT02553499|BG004|Baseline|MK-1248 30 mg|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250252|NCT02553499|BG005|Baseline|MK-1248 60 mg|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250253|NCT02553499|BG006|Baseline|MK-1248 120 mg|Participants received MK-1248 120 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250254|NCT02553499|BG007|Baseline|MK-1248 170 mg|Participants received MK-1248 170 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250255|NCT02553499|BG008|Baseline|MK-1248 0.12 mg + Pembrolizumab|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250256|NCT02553499|BG009|Baseline|MK-1248 0.6 mg + Pembrolizumab|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250257|NCT02553499|BG010|Baseline|MK-1248 3 mg + Pembrolizumab|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250258|NCT02553499|BG011|Baseline|MK-1248 10 mg + Pembrolizumab|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250259|NCT02553499|BG012|Baseline|MK-1248 30 mg + Pembrolizumab|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250260|NCT02553499|BG013|Baseline|MK-1248 60 mg + Pembrolizumab|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250261|NCT02553499|BG014|Baseline|Total|Total of all reporting groups
11250262|NCT02553499|FG000|Participant Flow|MK-1248 0.12 mg|Participants received MK-1248 0.12 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250263|NCT02553499|FG001|Participant Flow|MK-1248 0.6 mg|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250264|NCT02553499|FG002|Participant Flow|MK-1248 3 mg|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
10969820|NCT00907621|FG000|Participant Flow|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
11250265|NCT02553499|FG003|Participant Flow|MK-1248 10 mg|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250266|NCT02553499|FG004|Participant Flow|MK-1248 30 mg|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250267|NCT02553499|FG005|Participant Flow|MK-1248 60 mg|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250268|NCT02553499|FG006|Participant Flow|MK-1248 120 mg|Participants received MK-1248 120 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250269|NCT02553499|FG007|Participant Flow|MK-1248 170 mg|Participants received MK-1248 170 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250270|NCT02553499|FG008|Participant Flow|MK-1248 0.12 mg + Pembrolizumab|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250271|NCT02553499|FG009|Participant Flow|MK-1248 0.6 mg + Pembrolizumab|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250272|NCT02553499|FG010|Participant Flow|MK-1248 3 mg + Pembrolizumab|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250273|NCT02553499|FG011|Participant Flow|MK-1248 10 mg + Pembrolizumab|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250274|NCT02553499|FG012|Participant Flow|MK-1248 30 mg + Pembrolizumab|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250275|NCT02553499|FG013|Participant Flow|MK-1248 60 mg + Pembrolizumab|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250276|NCT02553499|OG000|Outcome|MK-1248 0.12 mg|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250277|NCT02553499|OG001|Outcome|MK-1248 0.6 mg|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250278|NCT02553499|OG002|Outcome|MK-1248 3 mg|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250279|NCT02553499|OG003|Outcome|MK-1248 10 mg|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250280|NCT02553499|OG004|Outcome|MK-1248 30 mg|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250281|NCT02553499|OG005|Outcome|MK-1248 60 mg|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250282|NCT02553499|OG006|Outcome|MK-1248 120 mg|Participants received MK-1248 120 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250283|NCT02553499|OG007|Outcome|MK-1248 170 mg|Participants received MK-1248 170 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250284|NCT02553499|OG008|Outcome|MK-1248 0.12 mg + Pembrolizumab|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250285|NCT02553499|OG009|Outcome|MK-1248 0.6 mg + Pembrolizumab|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250286|NCT02553499|OG010|Outcome|MK-1248 3 mg + Pembrolizumab|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250287|NCT02553499|OG011|Outcome|MK-1248 10 mg + Pembrolizumab|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250288|NCT02553499|OG012|Outcome|MK-1248 30 mg + Pembrolizumab|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250289|NCT02553499|OG013|Outcome|MK-1248 60 mg + Pembrolizumab|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250290|NCT02553499|OG007|Outcome|MK-1248 170 mg|Participants received MK-1248 at selected monotherapy dose (170 mg) via IV infusion on Day 1 of each 21-day cycle for a maximum of 4 cycles (up to ~3 months).
10969821|NCT00907621|FG001|Participant Flow|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
11250291|NCT02553499|EG000|Reported Event|MK-1248 0.12 mg|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250292|NCT02553499|EG001|Reported Event|MK-1248 0.6 mg|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250293|NCT02553499|EG002|Reported Event|MK-1248 3 mg|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250294|NCT02553499|EG003|Reported Event|MK-1248 10 mg|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250295|NCT02553499|EG004|Reported Event|MK-1248 30 mg|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250296|NCT02553499|EG005|Reported Event|MK-1248 60 mg|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250297|NCT02553499|EG006|Reported Event|MK-1248 120 mg|Participants received MK-1248 120 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250298|NCT02553499|EG007|Reported Event|MK-1248 170 mg|Participants received MK-1248 170 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months).
11250299|NCT02553499|EG008|Reported Event|MK-1248 0.12 mg + Pembrolizumab|Participants received MK-1248 0.12 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250300|NCT02553499|EG009|Reported Event|MK-1248 0.6 mg + Pembrolizumab|Participants received MK-1248 0.6 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250301|NCT02553499|EG010|Reported Event|MK-1248 3 mg + Pembrolizumab|Participants received MK-1248 3 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250302|NCT02553499|EG011|Reported Event|MK-1248 10 mg + Pembrolizumab|Participants received MK-1248 10 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250303|NCT02553499|EG012|Reported Event|MK-1248 30 mg + Pembrolizumab|Participants received MK-1248 30 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250304|NCT02553499|EG013|Reported Event|MK-1248 60 mg + Pembrolizumab|Participants received MK-1248 60 mg via IV infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to approximately 3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 24 months).
11250305|NCT02553512|BG000|Baseline|Helius|Ingestible Sensor and Wearable Sensor
11250306|NCT02553512|FG000|Participant Flow|Helius|Ingestible Sensor and Wearable Sensor
11250307|NCT02553512|OG000|Outcome|Helius|Ingestible Sensor and Wearable Sensor
11250308|NCT02553512|EG000|Reported Event|Helius|Ingestible Sensor and Wearable Sensor
11250309|NCT02553538|BG000|Baseline|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
11250310|NCT02553538|BG001|Baseline|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
11250311|NCT02553538|BG002|Baseline|Total|Total of all reporting groups
11250312|NCT02553538|FG000|Participant Flow|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
11250313|NCT02553538|FG001|Participant Flow|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
11250314|NCT02553538|OG000|Outcome|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
11250315|NCT02553538|OG001|Outcome|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
11250316|NCT02553538|EG000|Reported Event|Patient Navigation Intervention|Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
11250317|NCT02553538|EG001|Reported Event|Standard of Care - No Intervention|Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
11250318|NCT02553629|BG000|Baseline|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
11250319|NCT02553629|BG001|Baseline|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
11250320|NCT02553629|BG002|Baseline|Total|Total of all reporting groups
11250321|NCT02553629|FG000|Participant Flow|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
11250322|NCT02553629|FG001|Participant Flow|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
11250323|NCT02553629|OG000|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
11250324|NCT02553629|OG001|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
11250325|NCT02553629|EG000|Reported Event|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
10969822|NCT00907621|OG000|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
11250326|NCT02553629|EG001|Reported Event|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
11250327|NCT02553746|BG000|Baseline|Ultrasound|Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
11250328|NCT02553746|BG001|Baseline|Landmarks|Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
11250329|NCT02553746|BG002|Baseline|Total|Total of all reporting groups
11250330|NCT02553746|FG000|Participant Flow|Ultrasound|Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
11250331|NCT02553746|FG001|Participant Flow|Landmarks|Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
11250332|NCT02553746|OG000|Outcome|Ultrasound|Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
11250333|NCT02553746|OG001|Outcome|Landmarks|Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
11250334|NCT02553746|EG000|Reported Event|Ultrasound|Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
11250335|NCT02553746|EG001|Reported Event|Landmarks|Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
11250336|NCT02553772|BG000|Baseline|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250337|NCT02553772|BG001|Baseline|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250338|NCT02553772|BG002|Baseline|Total|Total of all reporting groups
11250339|NCT02553772|FG000|Participant Flow|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250340|NCT02553772|FG001|Participant Flow|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250341|NCT02553772|OG000|Outcome|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250342|NCT02553772|OG001|Outcome|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250343|NCT02553772|EG000|Reported Event|OM3 Tear|Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250344|NCT02553772|EG001|Reported Event|REFRESH OPTIVE® ADVANCED|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
11250345|NCT02553798|BG000|Baseline|Glycopyrronium|Glycopyrronium Topical Wipes
11250346|NCT02553798|FG000|Participant Flow|Glycopyrronium|Glycopyrronium Topical Wipes
11250347|NCT02553798|OG000|Outcome|Glycopyrronium|Glycopyrronium Topical Wipes
11250348|NCT02553798|EG000|Reported Event|Glycopyrronium|"Glycopyrronium Topical Wipes~Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes"
11250349|NCT02553928|BG000|Baseline|Memantine (Once Daily)|Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
11250350|NCT02553928|BG001|Baseline|Memantine (Twice Daily)|10 mg given twice daily, tablets, orally AND Placebo tablets twice daily, orally
11250351|NCT02553928|BG002|Baseline|Total|Total of all reporting groups
11250352|NCT02553928|FG000|Participant Flow|Memantine (Once Daily)|Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
11250353|NCT02553928|FG001|Participant Flow|Memantine (Twice Daily)|Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
11250354|NCT02553928|OG000|Outcome|Memantine (Once Daily)|Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
11250355|NCT02553928|OG001|Outcome|Memantine (Twice Daily)|Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
11250356|NCT02553928|OG001|Outcome|Memantine (Twice Daily)|10 mg given twice daily, tablets, orally AND Placebo tablets twice daily, orally
11250357|NCT02553928|EG000|Reported Event|Memantine (Once Daily)|Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
11250358|NCT02553928|EG001|Reported Event|Memantine (Twice Daily)|Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
11250359|NCT02554019|BG000|Baseline|BT063 50 mg|"50 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250360|NCT02554019|BG001|Baseline|BT063 100 mg|"100 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250361|NCT02554019|BG002|Baseline|Placebo|"Placebo administered by IV infusion 8 times~Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250362|NCT02554019|BG003|Baseline|Total|Total of all reporting groups
11250363|NCT02554019|FG000|Participant Flow|BT063 50 mg|"50 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250364|NCT02554019|FG001|Participant Flow|BT063 100 mg|"100 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250365|NCT02554019|FG002|Participant Flow|Placebo|"Placebo administered by IV infusion 8 times~Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250366|NCT02554019|OG000|Outcome|BT063 50 mg|"50 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250367|NCT02554019|OG001|Outcome|BT063 100 mg|"100 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250368|NCT02554019|OG002|Outcome|Placebo|"Placebo administered by IV infusion 8 times~Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250369|NCT02554019|EG000|Reported Event|BT063 50 mg|"50 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250370|NCT02554019|EG001|Reported Event|BT063 100 mg|"100 mg BT063 administered by intravenous (IV) infusion 8 times~BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250371|NCT02554019|EG002|Reported Event|Placebo|"Placebo administered by IV infusion 8 times~Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)"
11250372|NCT02554279|BG000|Baseline|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
11250373|NCT02554279|BG001|Baseline|Recombinant FSH|Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250374|NCT02554279|BG002|Baseline|Total|Total of all reporting groups
11250375|NCT02554279|FG000|Participant Flow|Menotropin|Menotropins for injection, provided as a vial with powder (75 international units [IU] follicle stimulating hormone [FSH] activity and 75 IU luteinizing hormone [LH] activity) and a vial with diluent.
11250376|NCT02554279|FG001|Participant Flow|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant deoxyribonucleic acid (DNA) origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250377|NCT02554279|OG000|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
11250378|NCT02554279|OG001|Outcome|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250379|NCT02554279|OG000|Outcome|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
11250380|NCT02554279|OG000|Outcome|Menotropin, Stimulation Day 6|Menotropins for injection at stimulation Day 6. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
11250381|NCT02554279|OG001|Outcome|Recombinant FSH, Stimulation Day 6|Recombinant FSH at stimulation Day 6. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250382|NCT02554279|OG002|Outcome|Menotropin, Last Stimulation Day|Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
11250383|NCT02554279|OG003|Outcome|Recombinant FSH, Last Stimulation Day|Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
11250384|NCT02554279|OG003|Outcome|Recombinant FSH, Last Stimulation Day|recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250385|NCT02554279|OG001|Outcome|Recombinant FSH|Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250386|NCT02554279|EG000|Reported Event|Menotropin|Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
10969823|NCT00907621|OG001|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
10969824|NCT00907621|EG000|Reported Event|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
10969825|NCT00907621|EG001|Reported Event|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
10969826|NCT00907738|BG000|Baseline|Base Protocol 001|Vorinostat 400 mg daily (QD)
11250387|NCT02554279|EG001|Reported Event|Recombinant FSH|Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
11250388|NCT02554435|BG000|Baseline|Pedometer|"All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.~Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."
11250389|NCT02554435|BG001|Baseline|Electronic Activity Monitor|"All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features.~EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange."
11250390|NCT02554435|BG002|Baseline|Total|Total of all reporting groups
11250391|NCT02554435|FG000|Participant Flow|Pedometer|"All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.~Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."
10969827|NCT00907738|BG001|Baseline|Base Protocol 006|vorinostat 200 mg twice daily (BID)
10969828|NCT00907738|BG002|Baseline|Base Protocol 008|vorinostat 400 mg QD
10969829|NCT00907738|BG003|Baseline|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
10969830|NCT00907738|BG004|Baseline|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
10969831|NCT00907738|BG005|Baseline|Total|Total of all reporting groups
10969832|NCT00907738|FG000|Participant Flow|Base Protocol 001|Vorinostat 400 mg daily (QD)
10969833|NCT00907738|FG001|Participant Flow|Base Protocol 006|vorinostat 200 mg twice daily (BID)
11250392|NCT02554435|FG001|Participant Flow|Electronic Activity Monitor|"All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features.~EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange."
11250393|NCT02554435|OG000|Outcome|Pedometer|"All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.~Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."
11250394|NCT02554435|OG001|Outcome|Electronic Activity Monitor|"All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features.~EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange."
11250395|NCT02554435|OG001|Outcome|Electronic Activity Monitor|"All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features.~EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the"
11250396|NCT02554435|EG000|Reported Event|Pedometer|"All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.~Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."
11250397|NCT02554435|EG001|Reported Event|Electronic Activity Monitor|"All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features.~EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.~5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange."
11250398|NCT02554513|BG000|Baseline|All Participants|All participants received Electropalatography Treatment (EPG Tx) and Sound Production Treatment (SPT). Half the participants received EPG Tx first for 20 sessions. Following a 2 week washout period, those participants then received SPT for 20 sessions. The other half of the participants received the treatments in the opposite order.
11250399|NCT02554513|FG000|Participant Flow|EPG Tx Then Sound Production Treatment (SPT)|"Participants in this arm received EPG Treatment for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment (SPT) for 20 treatment sessions.~EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation.~SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback."
11250400|NCT02554513|FG001|Participant Flow|Sound Production Treatment (SPT) Then EPG Tx|"Participants in this arm received Sound Production Treatment - Blocked (SPT) for 20 treatment sessions. Following a 2 week washout period, participants received EPG Treatment for 20 treatment sessions.~SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback.~EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation."
10969834|NCT00907738|FG002|Participant Flow|Base Protocol 008|vorinostat 400 mg QD
11250401|NCT02554513|OG000|Outcome|EPG Treatment|EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
11250402|NCT02554513|OG001|Outcome|Sound Production Treatment|Sound Production Treatment: Articulatory-Kinematic Treatment
11250403|NCT02554513|OG000|Outcome|Treatment With EPG|Participants received articulatory-kinematic treatment in conjunction with visual-biofeedback via electropalatography (i.e., tongue movement/placement)
11250404|NCT02554513|OG001|Outcome|Sound Production Treatment|Participants received articulatory-kinematic treatment
11250405|NCT02554513|OG000|Outcome|Treatment With EPG|An articulatory-kinematic treatment in conjunction with visual biofeedback for tongue position
11250406|NCT02554513|OG001|Outcome|Sound Production Treatment|An articulatory-kinematic treatment
11250407|NCT02554513|OG000|Outcome|All Participants - Pre vs. Post Treatment|Aphasia Communication Outcome Measure (ACOM)
11250408|NCT02554513|OG000|Outcome|All Participants - Pre vs. Post Treatment|Assessment of Intelligibility of Dysarthric Speech (ASSIDS) - Word Level
11250409|NCT02554513|EG000|Reported Event|EPG Treatment: All Participants|"Participants in this arm received EPG Treatment for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment (SPT) for 20 treatment sessions.~EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation.~SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback."
11250410|NCT02554513|EG001|Reported Event|Sound Production Treatment: All Participants|"Participants in this arm received Sound Production Treatment - Blocked (SPT) for 20 treatment sessions. Following a 2 week washout period, participants received EPG Treatment for 20 treatment sessions.~SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback.~EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation (watch me, listen to me, say it with me), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation."
11250411|NCT02554656|BG000|Baseline|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11250412|NCT02554656|FG000|Participant Flow|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11250413|NCT02554656|OG000|Outcome|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11250414|NCT02554656|EG000|Reported Event|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion.
11250415|NCT02554682|BG000|Baseline|Sexual Health (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250416|NCT02554682|BG001|Baseline|Sexual Health (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250417|NCT02554682|BG002|Baseline|Alcohol Prevention (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250418|NCT02554682|BG003|Baseline|Alcohol Prevention (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250419|NCT02554682|BG004|Baseline|Sexual Health & Alcohol Control Group (Teen)|Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250420|NCT02554682|BG005|Baseline|Sexual Health & Alcohol Control Group (Parent)|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250421|NCT02554682|BG006|Baseline|Teen Driving (Teen)|"Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250422|NCT02554682|BG007|Baseline|Teen Driving (Parent)|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250423|NCT02554682|BG008|Baseline|Teen Driving Control (Teens)|Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250424|NCT02554682|BG009|Baseline|Teen Driving Control (Parent)|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250425|NCT02554682|BG010|Baseline|Total|Total of all reporting groups
11250426|NCT02554682|FG000|Participant Flow|Sexual Health (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250427|NCT02554682|FG001|Participant Flow|Sexual Health (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250428|NCT02554682|FG002|Participant Flow|Alcohol Prevention (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250429|NCT02554682|FG003|Participant Flow|Alcohol Prevention (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250430|NCT02554682|FG004|Participant Flow|Sexual Health & Alcohol Control Group (Teen)|Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250431|NCT02554682|FG005|Participant Flow|Sexual Health & Alcohol Group (Parent)|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250432|NCT02554682|FG006|Participant Flow|Teen Driving (Teen)|"Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250433|NCT02554682|FG007|Participant Flow|Teen Driving (Parent)|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250434|NCT02554682|FG008|Participant Flow|Teen Driving Control (Teen)|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250435|NCT02554682|FG009|Participant Flow|Teen Driving Control (Parent)|Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250436|NCT02554682|OG000|Outcome|Sexual Health (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250437|NCT02554682|OG001|Outcome|Sexual Health (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250438|NCT02554682|OG002|Outcome|Alcohol Prevention (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250439|NCT02554682|OG003|Outcome|Alcohol (Teen)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250440|NCT02554682|OG004|Outcome|Sexual Health & Alcohol Control Group (Parent)|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250441|NCT02554682|OG005|Outcome|Sexual Health and Alcohol Control Group (Teen)|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250442|NCT02554682|OG000|Outcome|Sexual Health (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
11250443|NCT02554682|OG001|Outcome|Sexual Health (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
10969835|NCT00907738|FG003|Participant Flow|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
10969836|NCT00907738|FG004|Participant Flow|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
11250444|NCT02554682|OG002|Outcome|Alcohol Prevention (Teen)|"Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250445|NCT02554682|OG003|Outcome|Alcohol Prevention (Parent)|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250446|NCT02554682|OG004|Outcome|Sexual Health & Alcohol Control Group (Teen)|Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250447|NCT02554682|OG005|Outcome|Sexual Health & Alcohol Group (Parent)|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250448|NCT02554682|OG000|Outcome|Teen Driving (Parents)|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250449|NCT02554682|OG001|Outcome|Teen Driving Control (Parents)|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250450|NCT02554682|OG000|Outcome|Teen Driving (Parent)|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250451|NCT02554682|OG001|Outcome|Teen Driving Control (Parent)|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250452|NCT02554682|OG000|Outcome|Teen Driving|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250453|NCT02554682|OG001|Outcome|Teen Driving Control|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250454|NCT02554682|EG000|Reported Event|Sexual Health|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager."
10969837|NCT00907738|OG000|Outcome|Base Protocol 001|Vorinostat 400 mg daily (QD)
11250455|NCT02554682|EG001|Reported Event|Alcohol Prevention|"Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.~Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving."
11250456|NCT02554682|EG002|Reported Event|Sexual Health & Alcohol Control Group|Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
11250457|NCT02554682|EG003|Reported Event|Teen Driving|"Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.~Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers."
11250458|NCT02554682|EG004|Reported Event|Teen Driving Control|Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
11250459|NCT02554721|BG000|Baseline|Group 1 (CYP2C19 EM)|Participants received cilostazol 100 milligrams (mg) twice daily (BID) for 7 consecutive days from Day 1 to Day 7 (Period A). A 7-day wash-out period (Period B) allowed a return to baseline in relation to platelet function (PF) and skin bleeding time (BT) from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with normal, extensive metabolic (EM) activity (CYP2C19 EM) received ASA 100 mg once daily (QD) for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to ASA 100 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250460|NCT02554721|BG001|Baseline|Group 2 (CYP2C19 EM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with normal EM activity (CYP2C19 EM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250461|NCT02554721|BG002|Baseline|Group 3 (CYP2C19 IM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with intermediate metabolic (IM) activity (CYP2C19 IM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250462|NCT02554721|BG003|Baseline|Group 4 CYP2C19 PM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with poor metabolic (PM) activity (CYP2C19 PM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250463|NCT02554721|BG004|Baseline|Not Assigned|Two participants who received cilostazol in Period A were not assigned to a group.
11250464|NCT02554721|BG005|Baseline|Total|Total of all reporting groups
11286380|NCT02887404|OG001|Outcome|Usual Care|"Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Usual Care: Standard of pain management care"
10969838|NCT00907738|OG001|Outcome|Base Protocol 006|vorinostat 200 mg twice daily (BID)
10969839|NCT00907738|OG002|Outcome|Base Protocol 008|vorinostat 400 mg QD
11250465|NCT02554721|FG000|Participant Flow|Group 1 (CYP2C19 EM)|Participants received cilostazol 100 milligrams (mg) twice daily (BID) for 7 consecutive days from Day 1 to Day 7 (Period A). A 7-day wash-out period (Period B) allowed a return to baseline in relation to platelet function (PF) and skin bleeding time (BT) from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with normal, extensive metabolic (EM) activity (CYP2C19 EM) received ASA 100 mg once daily (QD) for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to ASA 100 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250466|NCT02554721|FG001|Participant Flow|Group 2 (CYP2C19 EM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with normal EM activity (CYP2C19 EM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250467|NCT02554721|FG002|Participant Flow|Group 3 (CYP2C19 IM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with intermediate metabolic (IM) activity (CYP2C19 IM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250468|NCT02554721|FG003|Participant Flow|Group 4 CYP2C19 PM)|Participants received cilostazol 100 mg BID for 7 consecutive days from Day 1 to Day 7 (Period A). A 7- day wash-out period (Period B) allowed a return to baseline in relation to PF and skin BT from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). Participants with poor metabolic (PM) activity (CYP2C19 PM) received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit 7 days after last administration of cilostazol (from Day 1 to Day 7) (Period C). In the following week, participants received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250469|NCT02554721|FG004|Participant Flow|Not Assigned|Two participants who received cilostazol in Period A were not assigned to a group.
11250470|NCT02554721|OG000|Outcome|Acetylsalicylic Acid - Cilostazol|Participants with normal CYP2C19 activity (EM) (Group 1) who received ASA 100 mg QD for 7 consecutive days from Day 15 to Day 21 (Period C) went on to receive cilostazol 100 mg BID as an add-on therapy to ASA 100 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250471|NCT02554721|OG001|Outcome|Clopidogrel - Cilostazol|Participants with EM, IM, and PM CYP2C19 activity (Groups 2-4, respectively) who received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21 (Period C) went on to receive cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35 (Period D).
11250472|NCT02554721|EG000|Reported Event|Cilostazol|All 77 enrolled participants received cilostazol 100 milligrams (mg) twice daily (BID) for 7 consecutive days from Day 1 to Day 7. A 7-day wash-out period (Period B) allowed a return to baseline in relation to platelet function (PF) and skin bleeding time (BT) from Day 8 to Day 14. Participants who failed to return to baseline with respect to PF and skin BT were retested within a further week (Day 15 to Day 21). After returning to baseline, all participants were stratified and randomized to the following 4 treatment groups in a 1:1:1:1 ratio for treatment in Periods C and D: Group 1, normal, extensive metabolizer (EM); Group 2, EM; Group 3, intermediate metabolizer (IM); Group 4, poor metabolizer (PM).
11250473|NCT02554721|EG001|Reported Event|Acetylsalicylic Acid|Participants with extensive CYP2C19 activity (EM) received ASA 100 mg QD for 7 consecutive days from Day 15 to Day 21, or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit at 7 days after last administration of cilostazol (from Day 1 to Day 7).
11250474|NCT02554721|EG002|Reported Event|Clopidogrel|Participants with EM, IM, and PM CYP2C19 activity received clopidogrel 75 mg QD for 7 consecutive days from Day 15 to Day 21, or Day 22 to Day 28 for participants who failed to return to baseline with respect to PF testing and skin BT at the scheduled visit at 7 days after last administration of cilostazol (from Day 1 to Day 7).
11250475|NCT02554721|EG003|Reported Event|Acetylsalicylic Acid - Cilostazol|Participants with extensive CYP2C19 activity (EM) received cilostazol 100 mg BID as an add-on therapy to ASA 100 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35.
11250476|NCT02554721|EG004|Reported Event|Clopidogrel - Cilostazol|Participants with EM, IM, and PM CYP2C19 activity received cilostazol 100 mg BID as an add-on therapy to clopidogrel 75 mg QD for 7 consecutive days from Day 22 to Day 28 or Day 29 to Day 35.
11250477|NCT02554760|BG000|Baseline|CoolSculpting Treatment|The ZELTIQ CoolSculpting System: The CoolSculpting device and CoolCore applicator will be used to perform the treatments.
10969840|NCT00907738|OG003|Outcome|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
11250478|NCT02554760|FG000|Participant Flow|Left Side With Crown Cooling Insert, Right Side Std CoolCore|Crown Cooling Insert (CCI) used for treatment on left flank at protocol-defined temperature and duration. Right flank treated using standard CoolCore applicator at protocol-defined temperature and duration.
11250479|NCT02554760|FG001|Participant Flow|Left Side Std CoolCore, Right Side With Crown Cooling Insert|Left flank treated with standard CoolCore applicator at protocol-defined temperature and duration. Right side treated with Crown Cooling Insert at protocol-defined temperature and duration.
11250480|NCT02554760|OG000|Outcome|CoolSculpting Treatment With Standard CoolCore Applicator|19 subjects received treatment for 60 minutes in duration at a protocol-defined temperature on one flank.
11250481|NCT02554760|OG001|Outcome|CoolSculpting Treatment/ CoolCore Applicator Plus CCI|19 subjects received treatment for a duration of 35 minutes at a protocol-defined temperature on the contralateral flank.
11250482|NCT02554760|OG000|Outcome|CoolSculpting Treatment|"The ZELTIQ CoolSculpting System: The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert (CCI) will be used to perform the treatments.~There were zero Unanticipated Adverse Device Events or device and/or procedure-related adverse events reported, therefore, both arms were aggregated for this analysis."
11250483|NCT02554760|OG000|Outcome|Standard CoolCore Without CCI|The CoolSculpting device and standard CoolCore applicator without the Crown Cooling Insert.
11250484|NCT02554760|OG001|Outcome|Flank Treated With CoolCore + CCI|CoolCore Applicator with Crown Cooling Insert
11250485|NCT02554760|EG000|Reported Event|CoolSculpting Using Standard CoolCore|The CoolSculpting device using standard CoolCore applicator
11250486|NCT02554760|EG001|Reported Event|CoolSculpting Device Using Crown Cooling Insert|The CoolSculpting device using applicator and Crown Cooling Insert
11250487|NCT02554786|BG000|Baseline|QMF149 150/320 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
11250488|NCT02554786|BG001|Baseline|QMF149 150/160 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
11250489|NCT02554786|BG002|Baseline|MF 800 μg|MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
11250490|NCT02554786|BG003|Baseline|MF 400 μg|MF 400 μg was delivered o.d. via Twisthaler® in the evening.
11250491|NCT02554786|BG004|Baseline|Salmeterol/Fluticasone 50/500 μg|Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
11250492|NCT02554786|BG005|Baseline|Total|Total of all reporting groups
11250493|NCT02554786|FG000|Participant Flow|QMF149 150/320 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered once daily (o.d.) via Concept1 inhaler in the evening.
11250494|NCT02554786|FG001|Participant Flow|QMF149 150/160 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
11250495|NCT02554786|FG002|Participant Flow|MF 800 μg|Mometasone furoate (MF) 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
11250496|NCT02554786|FG003|Participant Flow|MF 400 μg|MF 400 μg was delivered o.d. via Twisthaler® in the evening.
11250497|NCT02554786|FG004|Participant Flow|Salmeterol/Fluticasone 50/500 μg|Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
11250498|NCT02554786|OG000|Outcome|QMF149 150/320 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
11250499|NCT02554786|OG001|Outcome|QMF149 150/160 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
11250500|NCT02554786|OG002|Outcome|MF 800 μg|MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
11250501|NCT02554786|OG003|Outcome|MF 400 μg|MF 400 μg was delivered o.d. via Twisthaler® in the evening.
11250502|NCT02554786|OG004|Outcome|Salmeterol/Fluticasone 50/500 μg|Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
11250503|NCT02554786|OG003|Outcome|MF 400 μg|MF 400 μg was delivered o.d via Twisthaler® in the evening
11250504|NCT02554786|OG004|Outcome|Salmeterol /Fluticasone 50/500 μg|Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
11250505|NCT02554786|OG000|Outcome|QMF149 150/320 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening
11250506|NCT02554786|OG001|Outcome|QMF149 150/160 μg|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d via Concept1 inhaler in the evening
11250507|NCT02554786|EG000|Reported Event|QMF 150/320|QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
11250508|NCT02554786|EG001|Reported Event|QMF 150/160|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
11250509|NCT02554786|EG002|Reported Event|MF 800|MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
11250510|NCT02554786|EG003|Reported Event|MF 400|MF 400 μg was delivered o.d. via Twisthaler® in the evening.
11250511|NCT02554786|EG004|Reported Event|S/F 50/500|Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
11250512|NCT02554799|BG000|Baseline|40 mg MMV390048 Form A Fasted|40 mg MMV390048 tablet formulation A fasted
11250513|NCT02554799|BG001|Baseline|40 mg MMV390048 Form B Fasted|40 mg MMV390048 tablet formulation B fasted
11250514|NCT02554799|BG002|Baseline|Total|Total of all reporting groups
11250515|NCT02554799|FG000|Participant Flow|40 mg MMV390048 Form A Fasted|40 mg MMV390048 tablet formulation A fasted
11250516|NCT02554799|FG001|Participant Flow|40 mg MMV390048 Form B Fasted|40 mg MMV390048 tablet formulation B fasted
11250517|NCT02554799|OG000|Outcome|40 mg MMV390048 Form A Fasted|40 mg MMV390048 tablet formulation A fasted
11250518|NCT02554799|OG001|Outcome|40 mg MMV390048 Form B Fasted|40 mg MMV390048 tablet formulation B fasted
11250519|NCT02554799|EG000|Reported Event|40 mg MMV390048 Form A Fasted|40 mg MMV390048 tablet formulation A fasted
11250520|NCT02554799|EG001|Reported Event|40 mg MMV390048 Form B Fasted|40 mg MMV390048 tablet formulation B fasted
11250521|NCT02554877|BG000|Baseline|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250522|NCT02554877|BG001|Baseline|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250523|NCT02554877|BG002|Baseline|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250524|NCT02554877|BG003|Baseline|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250525|NCT02554877|BG004|Baseline|Total|Total of all reporting groups
11250526|NCT02554877|FG000|Participant Flow|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250527|NCT02554877|FG001|Participant Flow|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250528|NCT02554877|FG002|Participant Flow|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250529|NCT02554877|FG003|Participant Flow|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250530|NCT02554877|OG000|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250531|NCT02554877|OG001|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250532|NCT02554877|OG002|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250533|NCT02554877|OG003|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250534|NCT02554877|EG000|Reported Event|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250535|NCT02554877|EG001|Reported Event|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250536|NCT02554877|EG002|Reported Event|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250537|NCT02554877|EG003|Reported Event|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
11250538|NCT02554890|BG000|Baseline|Enalapril|"Initial dose for patients randomized to enalapril were determined by the blood pressure at the time of randomization. Study treatment were titrated to the target dose of enalapril 10 mg bid. Titration were based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement.~Patients were required to take a total of two tablets twice daily (one tablet of active enalapril, second from sacubitril and valsartan matching placebo pack)"
11250539|NCT02554890|BG001|Baseline|Sacubitril/Valsartan (LCZ696)|Initial dose for patients randomized to sacubitril/valsartan (LCZ696) was determined by the blood pressure at the time of randomization. Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg bid (Dose Level 3). Titration was based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement. Patients were required to take a total of two tablets twice daily (one tablet of active sacubitril and valsartan and one tablet of enalapril matching placebo pack).
11250540|NCT02554890|BG002|Baseline|Total|Total of all reporting groups
11250541|NCT02554890|FG000|Participant Flow|Enalapril|"Initial dose for patients randomized to enalapril were determined by the blood pressure at the time of randomization. Study treatment were titrated to the target dose of enalapril 10 mg bid. Titration were based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement.~Patients were required to take a total of two tablets twice daily (one tablet of active enalapril, second from sacubitril and valsartan matching placebo pack)"
11250542|NCT02554890|FG001|Participant Flow|Sacubitril/Valsartan (LCZ696)|Initial dose for patients randomized to sacubitril/valsartan (LCZ696) was determined by the blood pressure at the time of randomization. Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg bid (Dose Level 3). Titration was based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement. Patients were required to take a total of two tablets twice daily (one tablet of active sacubitril and valsartan and one tablet of enalapril matching placebo pack).
11250543|NCT02554890|OG000|Outcome|Enalapril|"Initial dose for patients randomized to enalapril were determined by the blood pressure at the time of randomization. Study treatment were titrated to the target dose of enalapril 10 mg bid. Titration were based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement.~Patients were required to take a total of two tablets twice daily (one tablet of active enalapril, second from sacubitril and valsartan matching placebo pack)"
11250544|NCT02554890|OG001|Outcome|Sacubitril/Valsartan (LCZ696)|Initial dose for patients randomized to sacubitril/valsartan (LCZ696) was determined by the blood pressure at the time of randomization. Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg bid (Dose Level 3). Titration was based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement. Patients were required to take a total of two tablets twice daily (one tablet of active sacubitril and valsartan and one tablet of enalapril matching placebo pack).
11250545|NCT02554890|EG000|Reported Event|Double Blind Phase Enalapril|Patients who received Enalapril in the double-blind phase.
11250546|NCT02554890|EG001|Reported Event|Double Blind Phase Sacubitril/Valsartan|Patients who received Sacubitril/Valsartan in the double-blind phase.
11250547|NCT02554890|EG002|Reported Event|Open-Label Phase Sacubitril/Valsartan|All patients who received sacubitril/valsartan in the open-label phase.
11250548|NCT02554890|EG003|Reported Event|Pooled Phase Sacubitril/Valsartan|All patients who received a dose of sacubitril/valsartan either in the double-blind phase or open-label phase.
11250549|NCT02554903|BG000|Baseline|Macitentan 10 Milligrams (mg)|Participants (with pulmonary hypertension [PH] after a left ventricular assist device [LVAD] implantation) received macitentan 10 mg orally once daily up to Week 12.
11250550|NCT02554903|BG001|Baseline|Placebo|Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
11250551|NCT02554903|BG002|Baseline|Total|Total of all reporting groups
11250552|NCT02554903|FG000|Participant Flow|Macitentan 10 Milligrams (mg)|Participants (with pulmonary hypertension [PH] after a left ventricular assist device [LVAD] implantation) received macitentan 10 mg orally once daily up to Week 12.
11250553|NCT02554903|FG001|Participant Flow|Placebo|Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
11250554|NCT02554903|OG000|Outcome|Macitentan 10 Milligrams (mg)|Participants (with pulmonary hypertension [PH] after a left ventricular assist device [LVAD] implantation) received macitentan 10 mg orally once daily up to Week 12.
11250555|NCT02554903|OG001|Outcome|Placebo|Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
11250556|NCT02554903|OG000|Outcome|Macitentan 10 Milligrams (mg)|Participants (with PH after a LVAD implantation) received macitentan 10 mg orally once daily up to Week 12.
11250557|NCT02554903|EG000|Reported Event|Macitentan 10 Milligrams (mg)|Participants (with pulmonary hypertension [PH] after a left ventricular assist device [LVAD] implantation) received macitentan 10 mg orally once daily up to Week 12.
11250558|NCT02554903|EG001|Reported Event|Placebo|Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
11250559|NCT02554929|BG000|Baseline|Taming Sneaky Fears Group|"An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child group."
11250560|NCT02554929|BG001|Baseline|Parent Psychoeducation and Child Socialization Group|"An 11 week (introduction plus 10 week) manualized treatment protocol focusing on parent psychoeducation and child socialization in children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group."
11250561|NCT02554929|BG002|Baseline|Total|Total of all reporting groups
11250562|NCT02554929|FG000|Participant Flow|Taming Sneaky Fears Group|"An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child group."
11250563|NCT02554929|FG001|Participant Flow|Parent Psychoeducation and Child Socialization Group|"An 11 week (introduction plus 10 week) manualized treatment protocol focusing on parent psychoeducation and child socialization in children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group."
11250564|NCT02554929|OG000|Outcome|Taming Sneaky Fears Group|"An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child group."
11250565|NCT02554929|OG001|Outcome|Parent Psychoeducation and Child Socialization Group|"An 11 week (introduction plus 10 week) manualized treatment protocol focusing on parent psychoeducation and child socialization in children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group."
11250566|NCT02554929|EG000|Reported Event|Taming Sneaky Fears Group|"An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child group."
11250567|NCT02554929|EG001|Reported Event|Parent Psychoeducation and Child Socialization Group|"An 11 week (introduction plus 10 week) manualized treatment protocol focusing on parent psychoeducation and child socialization in children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.~Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group."
11250568|NCT02554981|BG000|Baseline|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
11250569|NCT02554981|FG000|Participant Flow|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
11250570|NCT02554981|OG000|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
11250571|NCT02554981|EG000|Reported Event|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
11250572|NCT02555098|BG000|Baseline|Overall Study|Each subject randomized to wear either the Sapphire lenses (test) or senofilcon A contact lenses (control) as a matched pair for two weeks and cross over to the second matched pair for two weeks.
11250573|NCT02555098|FG000|Participant Flow|Sapphire Test Lenses Then Senofilcon A Lenes|"Each subject was randomized to wear the Investigational lenses (test) for two weeks then cross-over to senofilcon A contact lenses (control) for two weeks.~Sapphire contact lenses: Contact Lenses Senofilcon A : Contact lenses"
11250574|NCT02555098|FG001|Participant Flow|Senofilcon A Then Sapphire Test Lenses|"Each subject was randomized to wear the senofilcon A contact lenses (control) for two weeks then cross-over to Sapphire lenses (test) for two weeks.~Senofilcon A : Contact lenses Sapphire lenses: Contact Lenses"
11250575|NCT02555098|OG000|Outcome|Sapphire Lenses|"Each subject randomized to wear the Sapphire lenses (test) for two weeks.~Sapphire lenses: Contact lenses"
11250576|NCT02555098|OG001|Outcome|Senofilcon A|"Each subject randomized to wear senofilcon A contact lenses (control) for two weeks.~senofilcon A contact lenses: Contact lenses"
11250577|NCT02555098|OG000|Outcome|Sapphire Lenses|"Each subject randomized to wear the Sapphirel lenses (test) for two weeks.~Sapphire lenses: Contact lenses"
11250578|NCT02555098|OG000|Outcome|Overall Study|"Each subject randomized to wear the Sapphire lenses (test) and senofilcon A contact lenses for two weeks in this cross-over study.~Sapphire contact lenses: Contact lenses senofilcon A contact lenses : Contact lenses"
11250579|NCT02555098|OG000|Outcome|Sapphire Contact Lenses|"Each subject randomized to wear the Sapphire lenses (test) for two weeks.~Sapphire contact lenses: Contact lenses"
11250580|NCT02555098|OG000|Outcome|Sapphire Lenses|"Each subject randomized to wear the Sapphire lenses (test) for two weeks.~Sapphire contact lenses: Contact lenses"
11250581|NCT02555098|EG000|Reported Event|Sapphire Contact Lenses|"Each subject randomized to wear the Sapphire lenses (test) for two weeks.~Sapphire contact lenses: Contact lenses"
11250582|NCT02555098|EG001|Reported Event|Senofilcon A|"Each subject randomized to wear senofilcon A contact lenses (control) for two weeks.~senofilcon A contact lenses: Contact lenses"
11250583|NCT02555215|BG000|Baseline|Dimethyl Fumarate|Participants will receive 120 mg capsule(s) taken orally.
11250584|NCT02555215|FG000|Participant Flow|Dimethyl Fumarate|Participants will receive 120 mg capsule(s) taken orally.
11250585|NCT02555215|OG000|Outcome|Dimethyl Fumarate|Participants will receive 120 mg capsule(s) taken orally.
11250586|NCT02555215|EG000|Reported Event|BG00012|Participants will receive 120 mg capsule(s) taken orally.
11250587|NCT02555228|BG000|Baseline|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy."
11250588|NCT02555228|BG001|Baseline|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy."
11250589|NCT02555228|BG002|Baseline|Total|Total of all reporting groups
11250590|NCT02555228|FG000|Participant Flow|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250591|NCT02555228|FG001|Participant Flow|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250592|NCT02555228|OG000|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250593|NCT02555228|OG001|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250594|NCT02555228|EG000|Reported Event|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250595|NCT02555228|EG001|Reported Event|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
11250596|NCT02555306|BG000|Baseline|0.5 mg of DE-122|Single intravitreal injection of Low Dose DE-122 Injectable Solution
11250597|NCT02555306|BG001|Baseline|1.0 mg of DE-122|Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
11250598|NCT02555306|BG002|Baseline|2.0 mg of DE-122|Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
11250599|NCT02555306|BG003|Baseline|4.0 mg of DE-122|Single intravitreal injection of High Dose DE-122 Injectable Solution
11250600|NCT02555306|BG004|Baseline|Total|Total of all reporting groups
11250601|NCT02555306|FG000|Participant Flow|0.5 mg of DE-122|Single intravitreal injection of Low Dose DE-122 Injectable Solution
11250602|NCT02555306|FG001|Participant Flow|1.0 mg of DE-122|Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
11250603|NCT02555306|FG002|Participant Flow|2.0 mg of DE-122|Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
11250604|NCT02555306|FG003|Participant Flow|4.0 mg of DE-122|Single intravitreal injection of High Dose DE-122 Injectable Solution
11250605|NCT02555306|OG000|Outcome|0.5 mg of DE-122|Single intravitreal injection of Low Dose DE-122 Injectable Solution
11250606|NCT02555306|OG001|Outcome|1.0 mg of DE-122|Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
11250607|NCT02555306|OG002|Outcome|2.0 mg of DE-122|Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
11250608|NCT02555306|OG003|Outcome|4.0 mg of DE-122|Single intravitreal injection of High Dose DE-122 Injectable Solution
11250609|NCT02555306|EG000|Reported Event|0.5 mg of DE-122|Single intravitreal injection of Low Dose DE-122
11250610|NCT02555306|EG001|Reported Event|1.0 mg of DE-122|Single intravitreal injection of Medium-Low Dose DE-122
11250611|NCT02555306|EG002|Reported Event|2.0 mg of DE-122|Single intravitreal injection of Medium-High Dose DE-122
11250612|NCT02555306|EG003|Reported Event|4.0 mg of DE-122|Single intravitreal injection of High Dose DE-122
11250613|NCT02555371|BG000|Baseline|Parts A/B: Mepolizumab 100mg SC|Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
11250614|NCT02555371|FG000|Participant Flow|Part A/B: Mepolizumab 100mg SC|Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
11250615|NCT02555371|FG001|Participant Flow|Part C: Placebo|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250616|NCT02555371|FG002|Participant Flow|Part C: Mepolizumab 100mg SC|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250617|NCT02555371|FG003|Participant Flow|Part D: Mepolizumab 100mg SC (Previous Placebo)|Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
11250618|NCT02555371|FG004|Participant Flow|Part D: Mepolizumab 100mg SC (Previous Mepolizumab)|Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C ).
11250619|NCT02555371|OG000|Outcome|Part C: Placebo|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250620|NCT02555371|OG001|Outcome|Part C: Mepolizumab 100mg SC|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250621|NCT02555371|EG000|Reported Event|Part A/B: Mepolizumab 100mg SC|Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
11250622|NCT02555371|EG001|Reported Event|Part C: Placebo|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250623|NCT02555371|EG002|Reported Event|Part C: Mepolizumab 100mg|Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
11250624|NCT02555371|EG003|Reported Event|Part D: Mepolizumab 100mg SC (Previous Placebo)|Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
10969841|NCT00907738|OG004|Outcome|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
11250625|NCT02555371|EG004|Reported Event|Part D: Mepolizumab 100mg SC (Previous Mepolizumab)|Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
11250626|NCT02555449|BG000|Baseline|[¹⁴C]-LY3202626|Single oral dose of LY3202626 containing (10 milligrams) 100 micro curies of radioactivity
11250627|NCT02555449|FG000|Participant Flow|[¹⁴C]-LY3202626|Single 10 milligram (mg) oral dose of LY3202626 containing 100 micro curies of radioactivity
11250628|NCT02555449|OG000|Outcome|[¹⁴C]-LY3202626|Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of [14C]-LY3202626.
11250629|NCT02555449|EG000|Reported Event|[¹⁴C]-LY3202626|Single 10 mg oral dose of LY3202626 containing 100 micro curies of radioactivity
11250630|NCT02555618|BG000|Baseline|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
11250631|NCT02555618|BG001|Baseline|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
11250632|NCT02555618|BG002|Baseline|Total|Total of all reporting groups
11250633|NCT02555618|FG000|Participant Flow|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
11250634|NCT02555618|FG001|Participant Flow|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
11250635|NCT02555618|OG000|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
11250636|NCT02555618|OG001|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
11250637|NCT02555618|EG000|Reported Event|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
11250638|NCT02555618|EG001|Reported Event|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
11250639|NCT02555631|BG000|Baseline|Lifestyle Intervention|"In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session~lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session"
10969842|NCT00907738|EG000|Reported Event|Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])|
10969843|NCT00907738|EG001|Reported Event|Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])|
11250640|NCT02555631|FG000|Participant Flow|Lifestyle Intervention|"In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session~lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session"
11250641|NCT02555631|OG000|Outcome|Lifestyle Intervention|"In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session~lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session"
11250642|NCT02555631|EG000|Reported Event|Lifestyle Intervention|"In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session~lifestyle: In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session"
11250643|NCT02555683|BG000|Baseline|QAW039 150 mg|QAW039 150 mg once daily
11250644|NCT02555683|BG001|Baseline|QAW039 450 mg|QAW039 450 mg once daily
11250645|NCT02555683|BG002|Baseline|Placebo|Placebo once daily
11250646|NCT02555683|BG003|Baseline|Total|Total of all reporting groups
11250647|NCT02555683|FG000|Participant Flow|QAW039 150 mg|QAW039 150 mg once daily
11250648|NCT02555683|FG001|Participant Flow|QAW039 450 mg|QAW039 450 mg once daily
11250649|NCT02555683|FG002|Participant Flow|Placebo|Placebo once daily
11250650|NCT02555683|OG000|Outcome|QAW039 150 mg|QAW039 150 mg once daily
11250651|NCT02555683|OG001|Outcome|QAW039 450 mg|QAW039 450 mg once daily
11250652|NCT02555683|OG002|Outcome|Placebo|Placebo once daily
11250653|NCT02555683|EG000|Reported Event|QAW039 150 mg|QAW039 150 mg
11250654|NCT02555683|EG001|Reported Event|QAW039 450 mg|QAW039 450 mg
11250655|NCT02555683|EG002|Reported Event|Placebo|Placebo
11250656|NCT02555722|BG000|Baseline|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
11250657|NCT02555722|BG001|Baseline|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
11250658|NCT02555722|BG002|Baseline|Total|Total of all reporting groups
11250659|NCT02555722|FG000|Participant Flow|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
11250660|NCT02555722|FG001|Participant Flow|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
11250661|NCT02555722|OG000|Outcome|Baseline|fanfilcon A lens (test)
11250662|NCT02555722|OG001|Outcome|Week 1|fanfilcon A lens (test)
11250663|NCT02555722|OG002|Outcome|Week 2|fanfilcon A lens (test)
11250664|NCT02555722|OG003|Outcome|Month 1|fanfilcon A lens (test)
11250665|NCT02555722|OG004|Outcome|Month 2|fanfilcon A lens (test)
11250666|NCT02555722|OG005|Outcome|Month 3|fanfilcon A lens (test)
11250667|NCT02555722|OG006|Outcome|Unscheduled|fanfilcon A lens (test)
11250668|NCT02555722|OG000|Outcome|Baseline|enfilcon A lens (control)
11250669|NCT02555722|OG001|Outcome|Week 1|enfilcon A lens (control)
11250670|NCT02555722|OG002|Outcome|Week 2|enfilcon A lens (control)
11250671|NCT02555722|OG003|Outcome|Month 1|enfilcon A lens (control)
11250672|NCT02555722|OG004|Outcome|Month 2|enfilcon A lens (control)
11250673|NCT02555722|OG005|Outcome|Month 3|enfilcon A lens (control)
11250674|NCT02555722|OG006|Outcome|Unscheduled|enfilcon A lens (control)
11250675|NCT02555722|OG000|Outcome|Week 1|fanfilcon A lens (test)
11250676|NCT02555722|OG001|Outcome|Week 2|fanfilcon A lens (test)
11250677|NCT02555722|OG002|Outcome|Month 1|fanfilcon A lens (test)
11250678|NCT02555722|OG003|Outcome|Month 2|fanfilcon A lens (test)
11250679|NCT02555722|OG004|Outcome|Month 3|fanfilcon A lens (test)
11250680|NCT02555722|OG000|Outcome|Week 1|enfilcon A lens (control)
11250681|NCT02555722|OG001|Outcome|Week 2|enfilcon A lens (control)
11250682|NCT02555722|OG002|Outcome|Month 1|enfilcon A lens (control)
11250683|NCT02555722|OG003|Outcome|Month 2|enfilcon A lens (control)
11250684|NCT02555722|OG004|Outcome|Month 3|enfilcon A lens (control)
11250685|NCT02555722|OG006|Outcome|Unscheduled|Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
11250686|NCT02555722|EG000|Reported Event|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
11250687|NCT02555722|EG001|Reported Event|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
11250688|NCT02555878|BG000|Baseline|Placebo|Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.
11250689|NCT02555878|BG001|Baseline|Rivaroxaban 10 mg|Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
11250690|NCT02555878|BG002|Baseline|Total|Total of all reporting groups
11250691|NCT02555878|FG000|Participant Flow|Placebo|Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.
10822080|NCT00074308|OG000|Outcome|Arm I|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
11250692|NCT02555878|FG001|Participant Flow|Rivaroxaban 10 mg|Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
11250693|NCT02555878|OG000|Outcome|Placebo|Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.
11250694|NCT02555878|OG001|Outcome|Rivaroxaban 10 mg|Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
11250695|NCT02555878|EG000|Reported Event|Placebo|Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.
11250696|NCT02555878|EG001|Reported Event|Rivaroxaban 10 mg|Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
11250697|NCT02555930|BG000|Baseline|Total Cohort|Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy or neuropathic pain)
11250698|NCT02555930|FG000|Participant Flow|Total Cohort|Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy and/or neuropathic pain)
11250699|NCT02555930|OG000|Outcome|Total Cohort|Whole cohort - Adults with HIV infection
11250700|NCT02555930|OG000|Outcome|Total Cohort|Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy and/or neuropathic pain)
11250701|NCT02555930|EG000|Reported Event|Total Cohort|Observational study whole cohort
11250702|NCT02556112|BG000|Baseline|Group Lifestyle Balance|"Participants receive the Group Lifestyle Balance intervention as per the standard curriculum~Group Lifestyle Balance: Content consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits. The instructors make themselves available to be contacted by participants outside of class to address participant concerns"
11250703|NCT02556112|BG001|Baseline|Better Body Better Life|"Participants receive the Better Body Better Life intervention as per the standard curriculum~Better Body Better Life: The BBBL program is an Air Force weight management program.). It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals. Each module is done in a classroom and is 2 hours long. One module per week is offered. Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class"
11286381|NCT02887404|OG000|Outcome|Spine Surgery Analgesic Pathway|"Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Spine surgery analgesic pathway: Enhanced pain management care"
11250704|NCT02556112|BG002|Baseline|Fitness Improvement Program|"Participants take the Fitness Improvement Program on-line~Fitness Improvement Program: The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material. The on-line FIP can be done all in one sitting or in segments. There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer. The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary. Each section has a short video presentation. The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals. Participants are then responsible for using the information for their own self-directed program."
11250705|NCT02556112|BG003|Baseline|Total|Total of all reporting groups
10969844|NCT00907738|EG002|Reported Event|Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])|
10969845|NCT00907738|EG003|Reported Event|Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)|
10969846|NCT00907738|EG004|Reported Event|Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
11250706|NCT02556112|FG000|Participant Flow|Group Lifestyle Balance|"Participants receive the Group Lifestyle Balance intervention as per the standard curriculum~Group Lifestyle Balance: Content consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits. The instructors make themselves available to be contacted by participants outside of class to address participant concerns"
11250707|NCT02556112|FG001|Participant Flow|Better Body Better Life|"Participants receive the Better Body Better Life intervention as per the standard curriculum~Better Body Better Life: The BBBL program is an Air Force weight management program.). It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals. Each module is done in a classroom and is 2 hours long. One module per week is offered. Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class"
11250708|NCT02556112|FG002|Participant Flow|Fitness Improvement Program|"Participants take the Fitness Improvement Program on-line~Fitness Improvement Program: The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material. The on-line FIP can be done all in one sitting or in segments. There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer. The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary. Each section has a short video presentation. The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals. Participants are then responsible for using the information for their own self-directed program."
11250709|NCT02556112|OG000|Outcome|Group Lifestyle Balance|"Participants receive the Group Lifestyle Balance intervention as per the standard curriculum~Group Lifestyle Balance: Content consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits. The instructors make themselves available to be contacted by participants outside of class to address participant concerns"
10822081|NCT00074308|EG000|Reported Event|Phase 1 - Dose 1|Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
10822082|NCT00074308|EG001|Reported Event|Phase 1 Dose 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
10822083|NCT00074308|EG002|Reported Event|Phase 1 Dose 3|Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
10969847|NCT00907738|EG005|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)|
10969848|NCT00907738|EG006|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)|
10969849|NCT00907738|EG007|Reported Event|Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)|
10969850|NCT00907738|EG008|Reported Event|Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
10969851|NCT00907777|BG000|Baseline|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
10969852|NCT00907777|BG001|Baseline|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
10969853|NCT00907777|BG002|Baseline|Total|Total of all reporting groups
10969854|NCT00907777|FG000|Participant Flow|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
11250710|NCT02556112|OG001|Outcome|Better Body Better Life|"Participants receive the Better Body Better Life intervention as per the standard curriculum~Better Body Better Life: The BBBL program is an Air Force weight management program.). It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals. Each module is done in a classroom and is 2 hours long. One module per week is offered. Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class"
11250711|NCT02556112|OG002|Outcome|Fitness Improvement Program|"Participants take the Fitness Improvement Program on-line~Fitness Improvement Program: The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material. The on-line FIP can be done all in one sitting or in segments. There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer. The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary. Each section has a short video presentation. The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals. Participants are then responsible for using the information for their own self-directed program."
11250712|NCT02556112|OG000|Outcome|Group Lifestyle Balance|"Participants receive the Group Lifestyle Balance intervention as per the standard curriculum~Group Lifestyle Balance: The content of the GLB program consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits."
11250713|NCT02556112|EG000|Reported Event|Group Lifestyle Balance|"Participants receive the Group Lifestyle Balance intervention as per the standard curriculum~Group Lifestyle Balance: Content consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits. The instructors make themselves available to be contacted by participants outside of class to address participant concerns"
11250714|NCT02556112|EG001|Reported Event|Better Body Better Life|"Participants receive the Better Body Better Life intervention as per the standard curriculum~Better Body Better Life: The BBBL program is an Air Force weight management program.). It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals. Each module is done in a classroom and is 2 hours long. One module per week is offered. Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class"
11250715|NCT02556112|EG002|Reported Event|Fitness Improvement Program|"Participants take the Fitness Improvement Program on-line~Fitness Improvement Program: The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material. The on-line FIP can be done all in one sitting or in segments. There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer. The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary. Each section has a short video presentation. The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals. Participants are then responsible for using the information for their own self-directed program."
11250716|NCT02556138|BG000|Baseline|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
11250717|NCT02556138|FG000|Participant Flow|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
11250718|NCT02556138|OG000|Outcome|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
11250719|NCT02556138|EG000|Reported Event|Orbera Intragastric Balloon|All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
11250720|NCT02556177|BG000|Baseline|mTBI Patient Group (Segment 1)|"1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)~MRI: MRI scanning"
10969855|NCT00907777|FG001|Participant Flow|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
11250721|NCT02556177|BG001|Baseline|Non-TBI Patients (Segment 2)|"Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~MRI: MRI scanning"
11250722|NCT02556177|BG002|Baseline|Total|Total of all reporting groups
11250723|NCT02556177|FG000|Participant Flow|mTBI Patient Group (Segment 1)|"1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)~MRI: MRI scanning"
11250724|NCT02556177|FG001|Participant Flow|Non-TBI Patients (Segment 2)|"Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~MRI: MRI scanning"
11250725|NCT02556177|OG000|Outcome|mTBI Patient Group (Segment 1)|"1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)~MRI: MRI scanning"
11250726|NCT02556177|OG001|Outcome|Non-TBI Patients (Segment 2)|"Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~MRI: MRI scanning"
11250727|NCT02556177|EG000|Reported Event|mTBI Patient Group (Segment 1)|"1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)~MRI: MRI scanning"
11250728|NCT02556177|EG001|Reported Event|Non-TBI Patients (Segment 2)|"Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit~MRI: MRI scanning"
11250729|NCT02556203|BG000|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
11250730|NCT02556203|BG001|Baseline|Antiplatelet|Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
11250731|NCT02556203|BG002|Baseline|Total|Total of all reporting groups
11250732|NCT02556203|FG000|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
11250733|NCT02556203|FG001|Participant Flow|Antiplatelet|Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
11250734|NCT02556203|OG000|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
10822084|NCT00074308|EG003|Reported Event|Phase 1 Dose 4|Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
10822085|NCT00074308|EG004|Reported Event|Phase 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
11250735|NCT02556203|OG001|Outcome|Antiplatelet|Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
11250736|NCT02556203|EG000|Reported Event|Rivaroxaban Arm|Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
11250737|NCT02556203|EG001|Reported Event|Antiplatelet Arm|Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
11250738|NCT02556255|BG000|Baseline|B-Laser™ Atherectomy Catheter|Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™.
11250739|NCT02556255|FG000|Participant Flow|B-Laser™ Atherectomy Catheter|Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™.
11250740|NCT02556255|OG000|Outcome|B-Laser™ Atherectomy Catheter|Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™.
11250741|NCT02556255|EG000|Reported Event|B-Laser™ Atherectomy Catheter|Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™.
11250742|NCT02556307|BG000|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
11250743|NCT02556307|FG000|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
11250744|NCT02556307|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
11250745|NCT02556307|EG000|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
11250746|NCT02556333|BG000|Baseline|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
11250747|NCT02556333|FG000|Participant Flow|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
11250748|NCT02556333|OG000|Outcome|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
11250749|NCT02556333|EG000|Reported Event|TAF Treatment|Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
11250750|NCT02556554|BG000|Baseline|Routine Care|Standard of Care in the Pregnancy and Women's Health clinic.
11250751|NCT02556554|BG001|Baseline|Dexcom G4 Platinum CGM System|"An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.~Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy"
11250752|NCT02556554|BG002|Baseline|Dexcom G4 Platinum CGM System With Share™|"A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.~Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™"
11250753|NCT02556554|BG003|Baseline|Total|Total of all reporting groups
11250754|NCT02556554|FG000|Participant Flow|Routine Care|Standard of Care in the Pregnancy and Women's Health clinic.
11250755|NCT02556554|FG001|Participant Flow|Dexcom G4 Platinum CGM System|"An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.~Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy"
11250756|NCT02556554|FG002|Participant Flow|Dexcom G4 Platinum CGM System With Share™|"A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.~Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™"
11250757|NCT02556554|FG003|Participant Flow|Followers for Dexcom Alone|Followers of Pregnant Women Using Dexcom Alone
11250758|NCT02556554|FG004|Participant Flow|Followers for Dexcom Share|Followers of Pregnant Women Using Dexcom with Share
11250759|NCT02556554|OG000|Outcome|Dexcom G4 Platinum CGM System|"An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.~Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy"
11250760|NCT02556554|OG001|Outcome|Dexcom G4 Platinum CGM System With Share™|"A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.~Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™"
11250761|NCT02556554|OG000|Outcome|Routine Care|Standard of Care in the Pregnancy and Women's Health clinic.
11250762|NCT02556554|OG001|Outcome|Dexcom G4 Platinum CGM System|"An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.~Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy"
11250763|NCT02556554|OG002|Outcome|Dexcom G4 Platinum CGM System With Share™|"A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.~Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™"
10822086|NCT00074412|BG000|Baseline|Nevirapine|For infants: extended treatment with NVP
10822087|NCT00074412|BG001|Baseline|Placebo|For infants: extended treatment with NVP placebo
11250764|NCT02556554|EG000|Reported Event|Dexcom G4 Platinum CGM System|"An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.~Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy"
11250765|NCT02556554|EG001|Reported Event|Dexcom G4 Platinum CGM System With Share™|"A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.~Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™"
11250766|NCT02556554|EG002|Reported Event|Followers of Dexcom G4 Platinum CGM System|Followers (family or friends) of Dexcom G4 Platinum CGM system
11250767|NCT02556554|EG003|Reported Event|Followers of Dexcom G4 Platinum CGM System With Share™|Followers (family or friends) of Dexcom G4 Platinum CGM system with Share™
11250768|NCT02556632|BG000|Baseline|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250769|NCT02556632|BG001|Baseline|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250770|NCT02556632|BG002|Baseline|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
11250771|NCT02556632|BG003|Baseline|Total|Total of all reporting groups
11250772|NCT02556632|FG000|Participant Flow|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250773|NCT02556632|FG001|Participant Flow|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250774|NCT02556632|FG002|Participant Flow|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
11250775|NCT02556632|OG000|Outcome|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250776|NCT02556632|OG001|Outcome|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250777|NCT02556632|OG002|Outcome|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
11250778|NCT02556632|EG000|Reported Event|Arm I (Curcumin-based Gel)|"Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Curcumin-based Gel: Applied topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250779|NCT02556632|EG001|Reported Event|Arm II (HPR Plus)|"Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Dermatologic Complications Management: Apply HPR Plus topically~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
11250780|NCT02556632|EG002|Reported Event|Arm III (Placebo Gel)|"Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Apply placebo gel topically~Questionnaire Administration: Ancillary studies"
11250781|NCT02556775|BG000|Baseline|Retrospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
10822088|NCT00074412|BG002|Baseline|Total|Total of all reporting groups
10822089|NCT00074412|FG000|Participant Flow|Placebo|For infants: extended treatment with NVP placebo
10822090|NCT00074412|FG001|Participant Flow|Nevirapine|For infants: extended treatment with NVP
10822091|NCT00074412|OG000|Outcome|Nevirapine|For infants: extended treatment with NVP
11250782|NCT02556775|BG001|Baseline|Prospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250783|NCT02556775|BG002|Baseline|Retrospective Cohort: Infants|Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250784|NCT02556775|BG003|Baseline|Prospective Cohort: Infants|Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250785|NCT02556775|BG004|Baseline|Total|Total of all reporting groups
11250786|NCT02556775|FG000|Participant Flow|Retrospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250787|NCT02556775|FG001|Participant Flow|Prospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250788|NCT02556775|FG002|Participant Flow|Retrospective Cohort: Infants|Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250789|NCT02556775|FG003|Participant Flow|Prospective Cohort: Infants|Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250790|NCT02556775|OG000|Outcome|Retrospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250791|NCT02556775|OG001|Outcome|Prospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250792|NCT02556775|OG002|Outcome|Retrospective Cohort: Infants|Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250793|NCT02556775|OG003|Outcome|Prospective Cohort: Infants|Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250794|NCT02556775|OG000|Outcome|Retrospective Cohort: Infants|Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250795|NCT02556775|OG001|Outcome|Prospective Cohort: Infants|Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250796|NCT02556775|EG000|Reported Event|Retrospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250797|NCT02556775|EG001|Reported Event|Prospective Cohort: Expectant Mothers|Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250798|NCT02556775|EG002|Reported Event|Retrospective Cohort: Infants|Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.
11250799|NCT02556775|EG003|Reported Event|Prospective Cohort: Infants|Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
11250800|NCT02556788|BG000|Baseline|CD5789 (Trifarotene) 50µg/g Cream|CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
11250801|NCT02556788|BG001|Baseline|Placebo Cream|Placebo cream applied once daily during 12 weeks.
11250802|NCT02556788|BG002|Baseline|Total|Total of all reporting groups
11250803|NCT02556788|FG000|Participant Flow|CD5789 (Trifarotene) 50µg/g Cream|CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
11250804|NCT02556788|FG001|Participant Flow|Placebo Cream|Placebo cream applied once daily during 12 weeks.
11250805|NCT02556788|OG000|Outcome|CD5789 (Trifarotene) 50µg/g Cream|CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
11250806|NCT02556788|OG001|Outcome|Placebo Cream|Placebo cream applied once daily during 12 weeks.
10969856|NCT00907777|OG000|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
11250807|NCT02556788|EG000|Reported Event|CD5789 (Trifarotene) 50µg/g Cream|CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
11250808|NCT02556788|EG001|Reported Event|Placebo Cream|Placebo cream applied once daily during 12 weeks.
11250809|NCT02556801|BG000|Baseline|Placebo|Patients received placebo (containing no allergen extract) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250810|NCT02556801|BG001|Baseline|SP 10,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250811|NCT02556801|BG002|Baseline|SP 40,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250812|NCT02556801|BG003|Baseline|SP 80,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250813|NCT02556801|BG004|Baseline|Total|Total of all reporting groups
11250814|NCT02556801|FG000|Participant Flow|Placebo|Subjects received placebo (containing no allergen extract) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250815|NCT02556801|FG001|Participant Flow|SP 10,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250816|NCT02556801|FG002|Participant Flow|SP 40,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250817|NCT02556801|FG003|Participant Flow|SP 80,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250818|NCT02556801|OG000|Outcome|Placebo|Subjects received placebo (containing no allergen extract) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250819|NCT02556801|OG001|Outcome|SP 10,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250820|NCT02556801|OG002|Outcome|SP 40,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250821|NCT02556801|OG003|Outcome|SP 80,000 AUN/ml|Subjects received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250822|NCT02556801|EG000|Reported Event|Placebo|Patients received placebo (containing no allergen extract) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250823|NCT02556801|EG001|Reported Event|SP 10,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 10,000 AUN/ml) sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250824|NCT02556801|EG002|Reported Event|SP 40,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 40,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250825|NCT02556801|EG003|Reported Event|SP 80,000 AUN/ml|Patients received SUBLIVAC FIX Phleum Pratense 80,000 AUN/ml sublingually. Subjects started with one drop and one drop was added each consecutive day until the maintenance dose of 5 drops per day was reached. Next treatment at maintenance dose was continued during 10 months.
11250826|NCT02556918|BG000|Baseline|Sitagliptin|Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.
11250827|NCT02556918|BG001|Baseline|Placebo|Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
11250828|NCT02556918|BG002|Baseline|Total|Total of all reporting groups
11250829|NCT02556918|FG000|Participant Flow|Sitagliptin|Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100
11250830|NCT02556918|FG001|Participant Flow|Placebo|Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
11250831|NCT02556918|OG000|Outcome|Sitagliptin|"Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate >1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day)~Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol."
11250832|NCT02556918|OG001|Outcome|Placebo|Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
11250833|NCT02556918|OG000|Outcome|Sitagliptin|Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100
11250834|NCT02556918|EG000|Reported Event|Sitagliptin|Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.
11250835|NCT02556918|EG001|Reported Event|Placebo|Placebo: One pill daily starting one day prior to surgery until discharge from the hospital
11250836|NCT02557035|BG000|Baseline|I.V. Palonosetron Infusion Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250837|NCT02557035|BG001|Baseline|I.V. Palonosetron Bolus Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250838|NCT02557035|BG002|Baseline|Total|Total of all reporting groups
11250839|NCT02557035|FG000|Participant Flow|I.V. Palonosetron Infusion Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250840|NCT02557035|FG001|Participant Flow|I.V. Palonosetron Bolus Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250841|NCT02557035|OG000|Outcome|I.V. Palonosetron Infusion Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250842|NCT02557035|OG001|Outcome|I.V. Palonosetron Bolus Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250843|NCT02557035|EG000|Reported Event|I.V. Palonosetron Infusion Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250844|NCT02557035|EG001|Reported Event|I.V. Palonosetron Bolus Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Palonosetron~Dexamethasone"
11250845|NCT02557100|BG000|Baseline|Treatment A|Abatacept Single Blind Treatment Period
11250846|NCT02557100|BG001|Baseline|Treatment B|Adalimumab Single Blind Treatment Period
11250847|NCT02557100|BG002|Baseline|Treatment C|Cumulative Abatacept Period
11250848|NCT02557100|BG003|Baseline|Total|Total of all reporting groups
11250849|NCT02557100|FG000|Participant Flow|Treatment A|Abatacept Single Blind Treatment Period
11250850|NCT02557100|FG001|Participant Flow|Treatment B|Adalimumab Single Blind Treatment Period
11250851|NCT02557100|FG002|Participant Flow|Treatment C|Cumulative Abatacept Period
11250852|NCT02557100|OG000|Outcome|Treatment A|Abatacept Single Blind Treatment Period
11250853|NCT02557100|OG001|Outcome|Treatment B|Adalimumab Single Blind Treatment Period
11250854|NCT02557100|OG002|Outcome|Treatment C|Cumulative Abatacept Period
11250855|NCT02557100|EG000|Reported Event|Treatment A|Abatacept Single Blind Treatment Period
11250856|NCT02557100|EG001|Reported Event|Treatment B|Adalimumab Single Blind Treatment Period
11250857|NCT02557100|EG002|Reported Event|Treatment C|Cumulative Abatacept Period
11250858|NCT02557178|BG000|Baseline|Activity Monitor Plus Health Coaching|"Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.~health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation."
11250859|NCT02557178|BG001|Baseline|Control|Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
11250860|NCT02557178|BG002|Baseline|Total|Total of all reporting groups
11250861|NCT02557178|FG000|Participant Flow|Activity Monitor Plus Health Coaching|"Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.~health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation."
11250862|NCT02557178|FG001|Participant Flow|Control|Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
11250863|NCT02557178|OG000|Outcome|Activity Monitor Plus Health Coaching|"Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.~health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation."
11250864|NCT02557178|OG001|Outcome|Control|Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
11250865|NCT02557178|EG000|Reported Event|Activity Monitor Plus Health Coaching|"Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.~health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation."
11250866|NCT02557178|EG001|Reported Event|Control|Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
11250867|NCT02557399|BG000|Baseline|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
11250868|NCT02557399|BG001|Baseline|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
11250869|NCT02557399|BG002|Baseline|Total|Total of all reporting groups
11250870|NCT02557399|FG000|Participant Flow|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
11250871|NCT02557399|FG001|Participant Flow|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
11250872|NCT02557399|OG000|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
11250873|NCT02557399|OG001|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
11250874|NCT02557399|OG000|Outcome|DUAC|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
11250875|NCT02557399|OG001|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
11250876|NCT02557399|OG001|Outcome|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
11250877|NCT02557399|EG000|Reported Event|Duac|Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
11250878|NCT02557399|EG001|Reported Event|ADA 0.1% +CLDM 1%|Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
11250879|NCT02557516|BG000|Baseline|Phase 1 Level 1 - 1 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 1 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250880|NCT02557516|BG001|Baseline|Phase 1 Level 2 - 2 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250881|NCT02557516|BG002|Baseline|Phase 1 Level 3 - 4 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250882|NCT02557516|BG003|Baseline|Phase 2 RP2D - 2 mg/kg|"During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1 part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250883|NCT02557516|BG004|Baseline|Total|Total of all reporting groups
11250884|NCT02557516|FG000|Participant Flow|Phase 1 Level 1 - 1 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 1mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250885|NCT02557516|FG001|Participant Flow|Phase 1 Level 2 - 2 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250886|NCT02557516|FG002|Participant Flow|Phase 1 Level 3 - 4 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration IPH2201 was administered every 4 weeks."
11250887|NCT02557516|FG003|Participant Flow|Phase 2 RP2D - 2 mg/kg|"During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1 part (2 mg/kg), combined with ibrutinib 420 mg orally, once daily, from the first administration and during 52 weeks.~The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
10969857|NCT00907777|OG001|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
11250888|NCT02557516|OG000|Outcome|Phase 1 Level 1 - 1 mg/kg|Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
11250889|NCT02557516|OG001|Outcome|Phase 1 Level 2 - 2 mg/kg|Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
11250890|NCT02557516|OG002|Outcome|Phase 1 Level 3 - 4 mg/kg|Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
11215624|NCT02300298|FG001|Participant Flow|Nintedanib Plus Docetaxel (Patient Disposition for Docetaxel)|"The patient received 2*100 milligram (mg) b.i.d. of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.~Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again."
11215625|NCT02300298|OG000|Outcome|Nintedanib Plus Docetaxel|The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
11215626|NCT02300298|EG000|Reported Event|Nintedanib Plus Docetaxel|The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
11215627|NCT02300311|BG000|Baseline|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
11215628|NCT02300311|BG001|Baseline|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
11215629|NCT02300311|BG002|Baseline|Total|Total of all reporting groups
11215630|NCT02300311|FG000|Participant Flow|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
11215631|NCT02300311|FG001|Participant Flow|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
11215632|NCT02300311|OG000|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
11215633|NCT02300311|OG001|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
11215634|NCT02300311|EG000|Reported Event|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
11215635|NCT02300311|EG001|Reported Event|Finalgon® Cream (Nicoboxil/ Nonivamide)|Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
11215636|NCT02300545|BG000|Baseline|Pazopanib|Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
11215637|NCT02300545|FG000|Participant Flow|Pazopanib|Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
11215638|NCT02300545|OG000|Outcome|Pazopanib|Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
11215639|NCT02300545|EG000|Reported Event|Pazopanib|Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
11215640|NCT02300558|BG000|Baseline|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
11215641|NCT02300558|FG000|Participant Flow|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~Open-label Extension (OLE): Eleclazine 6 mg or 3 mg tablets orally once daily"
11215642|NCT02300558|OG000|Outcome|Eleclazine|"Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24~OLE: Eleclazine 6 mg or 3 mg tablets orally once daily"
11215643|NCT02300558|EG000|Reported Event|Placebo|Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1
11250891|NCT02557516|OG000|Outcome|Phase 1 Level 1 - 1 mg/kg|"During phase 1b, patients received monalizumab, IV, at the dose of 1mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250892|NCT02557516|OG001|Outcome|Phase 1 Level 2 - 2 mg/kg|"During phase 1b, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250893|NCT02557516|OG002|Outcome|Phase 1 Level 3 - 4 mg/kg|"During phase 1b, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250894|NCT02557516|OG003|Outcome|Phase 2 RP2D - 2 mg/kg|"During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.~In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks"
11250895|NCT02557516|OG000|Outcome|Phase 1 Level 1 - 1 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 1 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250896|NCT02557516|OG001|Outcome|Phase 1 Level 2 - 2 mg/kg|"During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250897|NCT02557516|OG002|Outcome|Phase 1 Level 3 - 4 mg/kg|"During phase 1, patients receive monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250898|NCT02557516|OG003|Outcome|Phase 2 RP2D - 2 mg/kg|"During phase a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.~In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
11250899|NCT02557516|OG000|Outcome|Efficacy Population|"The efficacy population included all patients who have received at least one dose of monalizumab.~According to the protocol, patients who discontinued from monalizumab treatment due to disease progression before the end of 8 weeks of treatment were replaced. As one patient was withdrawn due to grade 3 hemolytic anemia attribuated to disease progressions at W4, 21 patients were included in the efficacy population."
11250900|NCT02557516|OG000|Outcome|ITT / Safety Population|The Intent-To-Treat / Safety population is defined by all phase 1 and phase 2a patients who received at least 1 administration of monalizumab were evaluable for progression-free survival and overall survival efficacy outcomes and for safety. 22 patients were included in the ITT / Safety population.
11250901|NCT02557516|OG000|Outcome|All ITT / Safety Population|The Intent-To-Treat / Safety population is defined by all phase 1 and phase 2a patients who received at least 1 administration of monalizumab were evaluable for progression-free survival and overall survival efficacy outcomes and for safety. 22 patients were included in the ITT / Safety population.
11250902|NCT02557516|EG000|Reported Event|1 mg/kg|During phase 1b, patients received monalizumab, IV, at the dose of 1mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
11250903|NCT02557516|EG001|Reported Event|2 mg/kg|During phase 1b and during phase 2a patients received monalizumab, IV, at the dose of 2 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
11250904|NCT02557516|EG002|Reported Event|4 mg/kg|During phase 1b, patients receivde monalizumab, IV, at the dose of 4 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
11250905|NCT02557555|BG000|Baseline|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
11250906|NCT02557555|FG000|Participant Flow|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil patient controlled analgesia, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
11250907|NCT02557555|OG000|Outcome|Yes %|Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.
11250908|NCT02557555|OG001|Outcome|No %|Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety
11250909|NCT02557555|EG000|Reported Event|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
11250910|NCT02557646|BG000|Baseline|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
11250911|NCT02557646|FG000|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
11250912|NCT02557646|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
11250913|NCT02557646|EG000|Reported Event|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
11250914|NCT02557698|BG000|Baseline|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
11250915|NCT02557698|BG001|Baseline|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
11250916|NCT02557698|BG002|Baseline|Total|Total of all reporting groups
11250917|NCT02557698|FG000|Participant Flow|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
11250918|NCT02557698|FG001|Participant Flow|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
11250919|NCT02557698|OG000|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
11250920|NCT02557698|OG001|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
11250921|NCT02557698|EG000|Reported Event|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
11250922|NCT02557698|EG001|Reported Event|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
11250923|NCT02558231|BG000|Baseline|Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag)|Participants received macitentan oral tablet, 10 milligrams (mg) once daily and tadalafil oral tablet, 20 mg, once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received selexipag oral tablet at a starting dose of 200 micrograms (mcg), twice daily from Day 15 up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250924|NCT02558231|BG001|Baseline|Double Oral Therapy (Macitentan, Tadalafil, and Placebo)|Participants received macitentan oral tablet, 10 mg once daily and tadalafil oral tablet, 20 once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received placebo matching to selexipag oral tablet, at a starting dose of 200 micrograms (mcg), twice daily from Day 15 and dose up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250925|NCT02558231|BG002|Baseline|Total|Total of all reporting groups
11250926|NCT02558231|FG000|Participant Flow|Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag)|Participants received macitentan oral tablet, 10 milligrams (mg) once daily and tadalafil oral tablet, 20 mg, once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received selexipag oral tablet at a starting dose of 200 micrograms (mcg), twice daily from Day 15 up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250927|NCT02558231|FG001|Participant Flow|Double Oral Therapy (Macitentan, Tadalafil, and Placebo)|Participants received macitentan oral tablet, 10 mg once daily and tadalafil oral tablet, 20 once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received placebo matching to selexipag oral tablet, at a starting dose of 200 micrograms (mcg), twice daily from Day 15 and dose up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250928|NCT02558231|OG000|Outcome|Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag)|Participants received macitentan oral tablet, 10 milligrams (mg) once daily and tadalafil oral tablet, 20 mg, once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received selexipag oral tablet at a starting dose of 200 micrograms (mcg), twice daily from Day 15 up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250929|NCT02558231|OG001|Outcome|Double Oral Therapy (Macitentan, Tadalafil, and Placebo)|Participants received macitentan oral tablet, 10 mg once daily and tadalafil oral tablet, 20 once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received placebo matching to selexipag oral tablet, at a starting dose of 200 micrograms (mcg), twice daily from Day 15 and dose up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250930|NCT02558231|EG000|Reported Event|Triple Oral Therapy (Macitentan, Tadalafil, and Selexipag)|Participants received macitentan oral tablet, 10 milligrams (mg) once daily and tadalafil oral tablet, 20 mg, once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received selexipag oral tablet at a starting dose of 200 micrograms (mcg), twice daily from Day 15 up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11215644|NCT02300558|EG001|Reported Event|Eleclazine Loading Dose (LD) 48 mg|Eleclazine 48 mg ( 8 x 6 mg tablets) administered orally on Day 2
11215645|NCT02300558|EG002|Reported Event|Eleclazine Maintenance Dose (MD) 3 mg|Eleclazine 3 mg (1 x 3 mg tablet) administered once daily from Day 3 to the Week 12 Visit
11215646|NCT02300558|EG003|Reported Event|Eleclazine MD 6 mg|Eleclazine 6 mg (1 x 6 mg tablet) administered orally from the day after the Week 12 Visit through Week 24 and open-label extension.
11215647|NCT02300558|EG004|Reported Event|All Eleclazine|"Loading Dose: Eleclazine 48 mg ( 8 x 6 mg tablets) administered on Day 2 and 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit~Maintenance dose: Eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24 and open-label extension.~Adverse events in this reporting group include those that occurred any time during the study by participants while receiving loading dose or maintenance dose of eleclazine."
11215648|NCT02300610|BG000|Baseline|Dose Escalation: Level 1 Dose|Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215649|NCT02300610|BG001|Baseline|Dose Escalation: Level 2 Dose|Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215650|NCT02300610|BG002|Baseline|Dose Expansion|Dose Expansion: Enzalutamide at recommended dose level with standard doses of cisplatin and gemcitabine.
11215651|NCT02300610|BG003|Baseline|Total|Total of all reporting groups
11215652|NCT02300610|FG000|Participant Flow|Dose Escalation: Level 1 Dose|Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215653|NCT02300610|FG001|Participant Flow|Dose Escalation- Level 2 Dose|Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215654|NCT02300610|FG002|Participant Flow|Dose Expansion|Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
11215655|NCT02300610|OG000|Outcome|Dose Escalation|Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215656|NCT02300610|OG000|Outcome|Dose Escalation: Level 1 Dose|Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215657|NCT02300610|OG001|Outcome|Dose Escalation: Level 2 Dose|Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
11215658|NCT02300610|OG002|Outcome|Dose Expansion|Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
11215659|NCT02300610|OG001|Outcome|Dose Escalation: Level 2 Dose|Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
11215660|NCT02300610|EG000|Reported Event|Dose Escalation: Dose Level 1|Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215661|NCT02300610|EG001|Reported Event|Dose Escalation: Level 2 Dose|Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
11215662|NCT02300610|EG002|Reported Event|Dose Expansion|Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
11215663|NCT02300727|BG000|Baseline|Mouthwash-standard Pharmacy Preparation|"Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.~Mouthwash-standard pharmacy preparation: Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine."
11215664|NCT02300727|BG001|Baseline|Curcumin|"Curcumin (BCM-95) administered by ingested mouth rinse three times per day. Subjects will be in this arm at the previously determine maximum tolerated dose (MTD).~Curcumin: After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops."
11215665|NCT02300727|BG002|Baseline|Curcumin-MTD 0.33g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215666|NCT02300727|BG003|Baseline|Curcumin-MTD 1g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215667|NCT02300727|BG004|Baseline|Curcumin-MTD 2g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215668|NCT02300727|BG005|Baseline|Curcumin-MTD 3g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215669|NCT02300727|BG006|Baseline|Total|Total of all reporting groups
11215670|NCT02300727|FG000|Participant Flow|Mouthwash-standard Pharmacy Preparation|"Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.~Mouthwash-standard pharmacy preparation: Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine."
11250931|NCT02558231|EG001|Reported Event|Double Oral Therapy (Macitentan, Tadalafil, and Placebo)|Participants received macitentan oral tablet, 10 mg once daily and tadalafil oral tablet, 20 once daily from Day 1 up to End of treatment (10 months after last participant was enrolled). Tadalafil was up-titrated from 20 mg to 40 mg on Day 8. In addition, participants received placebo matching to selexipag oral tablet, at a starting dose of 200 micrograms (mcg), twice daily from Day 15 and dose up-titrated to a maximum of 1600 mcg, up to End of treatment (10 months after last participant was enrolled).
11250932|NCT02558296|BG000|Baseline|Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet"
11250933|NCT02558296|BG001|Baseline|Placebo Tablets|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator"
11250934|NCT02558296|BG002|Baseline|Total|Total of all reporting groups
11250935|NCT02558296|FG000|Participant Flow|Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet"
11250936|NCT02558296|FG001|Participant Flow|Placebo Tablets|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator"
11250937|NCT02558296|OG000|Outcome|Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet"
11250938|NCT02558296|OG001|Outcome|Placebo Tablets|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator"
11250939|NCT02558296|OG000|Outcome|All Subjects: Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet~This group includes all subjects who have received bexagliflozin in the study."
11250940|NCT02558296|OG001|Outcome|All Subjects: Placebo Tablets|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator~This group includes all subjects who have received placebo in the study."
11250941|NCT02558296|OG002|Outcome|Subjects With HF History: Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet~This group includes subjects who reported a history of heart failure and randomized to the bexagliflozin arm."
11250942|NCT02558296|OG003|Outcome|Subjects With HF History: Placebo|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator~This group includes subjects who reported a history of heart failure and randomized to the placebo arm."
11250943|NCT02558296|EG000|Reported Event|Bexagliflozin Tablets, 20 mg|"Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.~Bexagliflozin: 20 mg, tablet"
11250944|NCT02558296|EG001|Reported Event|Placebo Tablets|"Each subject will receive placebo (inactive tablet) once daily for the duration of the study.~Placebo: 20 mg tablet to match active comparator"
11250945|NCT02558374|BG000|Baseline|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
11250946|NCT02558374|BG001|Baseline|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11250947|NCT02558374|BG002|Baseline|Total|Total of all reporting groups
11250948|NCT02558374|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11250949|NCT02558374|FG001|Participant Flow|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11250950|NCT02558374|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11250951|NCT02558374|OG001|Outcome|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11250952|NCT02558374|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.02% & Placebo|1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
11250953|NCT02558374|EG001|Reported Event|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
11250954|NCT02558400|BG000|Baseline|PG324 Ophthalmic Solution|PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250955|NCT02558400|BG001|Baseline|AR-13324 Ophthalmic Solution 0.02%|Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250956|NCT02558400|BG002|Baseline|Latanoprost Ophthalmic Solution 0.005%|Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250957|NCT02558400|BG003|Baseline|Total|Total of all reporting groups
11250958|NCT02558400|FG000|Participant Flow|PG324 Ophthalmic Solution 0.02%/0.005%|PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250959|NCT02558400|FG001|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250960|NCT02558400|FG002|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250961|NCT02558400|OG000|Outcome|PG324 Ophthalmic Solution|PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250962|NCT02558400|OG001|Outcome|AR-13324 Ophthalmic Solution 0.02%|Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250963|NCT02558400|OG002|Outcome|Latanoprost Ophthalmic Solution 0.005%|Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250964|NCT02558400|OG000|Outcome|PG324 Ophthalmic Solution 0.02%/0.005%|"Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution~PG324 Ophthalmic Solution 0.02%/0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)"
11250965|NCT02558400|OG001|Outcome|AR-13324 Ophthalmic Solution 0.02%|"Netarsudil 0.02% ophthalmic solution~Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)"
11250966|NCT02558400|OG002|Outcome|Latanoprost Ophthalmic Solution 0.005%|"Latanoprost 0.005% ophthalmic solution~Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)"
11250967|NCT02558400|EG000|Reported Event|PG324 Ophthalmic Solution|PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250968|NCT02558400|EG001|Reported Event|AR-13324 Ophthalmic Solution 0.02%|Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250969|NCT02558400|EG002|Reported Event|Latanoprost Ophthalmic Solution 0.005%|Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
11250970|NCT02558790|BG000|Baseline|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects received open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
11250971|NCT02558790|FG000|Participant Flow|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects took open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
11250972|NCT02558790|OG000|Outcome|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects took open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
11250973|NCT02558790|EG000|Reported Event|L-Threonic Acid Magnesium Salt (L-TAMS)|Subjects received open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.
11250974|NCT02558829|BG000|Baseline|Group A|"High likelihood of growth hormone deficiency (GHD):~Structural hypothalamic or pituitary lesions and low insulin-like growth factor 1 (IGF-1), and/or~Three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~Childhood onset GHD with structural lesions and low IGF-1."
11250975|NCT02558829|BG001|Baseline|Group B|"Intermediate likelihood of GHD:~• Eligible subjects not qualifying for either high or low likelihood (Group A/C)"
11250976|NCT02558829|BG002|Baseline|Group C|"Low likelihood of GHD:~One risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~Isolated idiopathic childhood onset GHD without additional pituitary deficits"
11250977|NCT02558829|BG003|Baseline|Group D|Healthy control. Healthy subjects matching Group A subjects by sex, age, body mass index (BMI), and estrogen status (females only).
11250978|NCT02558829|BG004|Baseline|Total|Total of all reporting groups
11250979|NCT02558829|FG000|Participant Flow|Group A Test Sequence MAC-ITT|"Group A: High likelihood of GHD:~structural hypothalamic or pituitary lesions and low IGF-1, and/or - three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~childhood onset GHD with structural lesions and low IGF-1.~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
11250980|NCT02558829|FG001|Participant Flow|Group A Test Sequence ITT-MAC|"Group A: High likelihood of GHD:~structural hypothalamic or pituitary lesions and low IGF-1, and/or - three or more pituitary hormone deficiencies (PHD) and low IGF-1, or~childhood onset GHD with structural lesions and low IGF-1~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
11250981|NCT02558829|FG002|Participant Flow|Group B Test Sequence MAC-ITT|"Group B: intermediate likelihood of GHD:~- eligible subjects not qualifying for either high or low likelihood (Group A/C)~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
11250982|NCT02558829|FG003|Participant Flow|Group B Test Sequence ITT- MAC|"Group B: intermediate likelihood of GHD:~- eligible subjects not qualifying for either high or low likelihood (Group A/C)~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
11250983|NCT02558829|FG004|Participant Flow|Group C Test Sequence MAC-ITT|"Group C: Low likelihood of GHD~one risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~isolated idiopathic childhood onset GHD without additional pituitary deficits.~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
11250984|NCT02558829|FG005|Participant Flow|Group C Test Sequence ITT-MAC|"Group C: Low likelihood of GHD~one risk factor for GHD only, such as history of distant traumatic brain injury (TBI) or one PHD only with otherwise normal pituitary function or~isolated idiopathic childhood onset GHD without additional pituitary deficits.~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
10822092|NCT00074412|OG001|Outcome|Placebo|For infants: extended treatment with NVP Placebo
11215671|NCT02300727|FG001|Participant Flow|Curcumin|"Curcumin (BCM-95) administered by ingested mouth rinse three times per day. Subjects will be in this arm at the previously determine maximum tolerated dose (MTD).~Curcumin: After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops."
11215672|NCT02300727|FG002|Participant Flow|Curcumin-MTD 0.33g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose level of 0.33g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215673|NCT02300727|FG003|Participant Flow|Curcumin-MTD 1g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose level of 1g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215674|NCT02300727|FG004|Participant Flow|Curcumin- MTD 2g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose level of 2g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215675|NCT02300727|FG005|Participant Flow|Curcumin- MTD 3g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participant at a dose level of 3g per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215676|NCT02300727|OG000|Outcome|Mouthwash-standard Pharmacy Preparation|"Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.~Mouthwash-standard pharmacy preparation: Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine."
11215677|NCT02300727|OG001|Outcome|Curcumin|"Curcumin (BCM-95) administered by ingested mouth rinse three times per day. Subjects will be in this arm at the previously determine maximum tolerated dose (MTD).~Curcumin: After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops."
11215678|NCT02300727|OG002|Outcome|Curcumin-MTD 0.33g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215679|NCT02300727|OG003|Outcome|Curcumin-MTD 1g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215680|NCT02300727|OG004|Outcome|Curcumin- MTD 2g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215681|NCT02300727|OG005|Outcome|Curcumin- MTD 3g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215682|NCT02300727|EG000|Reported Event|Mouthwash-standard Pharmacy Preparation|"Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine.~Mouthwash-standard pharmacy preparation: Standard mouth wash preparation administered by ingested mouth rinse three times per day.~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine."
11215683|NCT02300727|EG001|Reported Event|Curcumin|"Curcumin (BCM-95) administered by ingested mouth rinse three times per day. Subjects will be in this arm at the previously determine maximum tolerated dose (MTD).~Curcumin: After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops."
11215684|NCT02300727|EG002|Reported Event|Curcumin-MTD 0.33g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 0.33g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 0.33g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215685|NCT02300727|EG003|Reported Event|Curcumin-MTD 1g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 1g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 1g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11250985|NCT02558829|FG006|Participant Flow|Group D Test Sequence MAC-ITT|"Group D: Healthy control. Healthy subjects matching Group A subjects by sex, age, BMI, and estrogen status (females only).~Randomization of GHST administration to following test sequence:~1st Macimorelin-GHST (MAC), 2nd Insulin Tolerance Test (ITT).~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose.~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose."
11250986|NCT02558829|FG007|Participant Flow|Group D Test Sequence ITT-MAC|"Group D: Healthy control. Healthy subjects matching Group A subjects by sex, age, BMI, and estrogen status (females only).~Randomization of GHST administration to following test sequence:~1st Insulin Tolerance Test (ITT), 2nd Macimorelin-GHST (MAC)~Insulin Tolerance Test: administration of regular human insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose.~Macimorelin GHST: administration of macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose."
11250987|NCT02558829|OG000|Outcome|Positive MAC, Positive ITT|Test outcome positive for MAC and for ITT
11250988|NCT02558829|OG001|Outcome|Positive MAC, Negative ITT|Test outcome positive for MAC and negative for ITT
11250989|NCT02558829|OG002|Outcome|Negative MAC, Positive ITT|Test outcome negative for MAC and positive for ITT
11250990|NCT02558829|OG003|Outcome|Negative MAC, Negative ITT|Test outcome negative for MAC and for ITT
11250991|NCT02558829|OG000|Outcome|Insulin Tolerance Test (ITT), All Groups, SAF Population|All subjects of Group A, B, C, and D with at least one ITT performed: N=157
11250992|NCT02558829|OG001|Outcome|Macimorelin GHST (MAC), All Groups, SAF Population|All subjects of Group A, B, C, and D with at least one macimorelin GHST: N=154 (three subjects were not exposed to MAC but were exposed to ITT only).
11250993|NCT02558829|OG000|Outcome|MAC, Heart Rate at Pre-dose|Macimorelin GHST, heart rate (HR) value at test/time point pre-dose.
11250994|NCT02558829|OG001|Outcome|MAC, HR at Post-dose|Macimorelin GHST, HR value at test/time point 60 minutes post-dose.
11250995|NCT02558829|OG002|Outcome|ITT, HR at Pre-dose|Insulin Tolerance Test, HR value at test/time point pre-dose.
11250996|NCT02558829|OG003|Outcome|ITT, HR at Post-dose|Insulin Tolerance Test, HR value at test/time point 60 minutes post-dose.
11250997|NCT02558829|OG000|Outcome|Positive MAC, Group A|Positive test outcome of the MAC in subjects of AGHD likelihood group A (high likelihood)
11250998|NCT02558829|OG001|Outcome|Positive MAC, Group D|positive test outcome of the MAC in subjects of Group D (healthy matched controls)
11250999|NCT02558829|OG002|Outcome|Negative MAC, Group A|Negative test outcome of the MAC in subjects of AGHD likelihood group A (high likelihood)
11251000|NCT02558829|OG003|Outcome|Negative MAC, Group D|Negative test outcome of the MAC in subjects of Group D (healthy matched controls)
11251001|NCT02558829|OG000|Outcome|Positive MAC Core, Positive MAC Repeatability|Test outcome positive for MAC in core study part and positive for MAC in the repeatability extension.
11251002|NCT02558829|OG001|Outcome|Positive MAC Core, Negative MAC Repeatability|Test outcome positive for MAC in core study part and negative for MAC in the repeatability extension.
11251003|NCT02558829|OG002|Outcome|Negative MAC Core, Negative MAC Repeatability|Test outcome negative for MAC in core study part and negative for MAC in the repeatability extension.
11251004|NCT02558829|OG003|Outcome|Negative MAC Core, Positive MAC Repeatability|Test outcome negative for MAC in core study part and positive for MAC in the repeatability extension.
11251005|NCT02558829|EG000|Reported Event|Macimorelin GHST (MAC), SAF Population|"Macimorelin GHST (MAC): combined safety data from core study and repeatability extension (Amendment 1, European sites only)).~All subjects of Group A, B, C, D with at least one macimorelin GHST performed: N=154.~All subjects of Group A, B, C, D valid for safety (SAF) analysis: N=157. (three subjects were exposed to the ITT only).~Repeatability extension (planned repetition of the MAC): subjects of Group A, B, C valid for safety (SAF)analysis: N=34."
11251006|NCT02558829|EG001|Reported Event|Insulin Tolerance Test (ITT), SAF Population|Insulin Tolerance Test (ITT) All subjects of Group A, B, C, D with at least one ITT performed: N=157. All subjects of Group A, B, C, D valid for safety (SAF) analysis: N=157.
11251007|NCT02558894|BG000|Baseline|Durvalumab (MEDI4736) Plus Tremelimumab|"Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48.~For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion."
11251008|NCT02558894|BG001|Baseline|Durvalumab (MEDI4736) Monotherapy|Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
11251009|NCT02558894|BG002|Baseline|Total|Total of all reporting groups
11251010|NCT02558894|FG000|Participant Flow|Durvalumab (MEDI4736) Plus Tremelimumab|"Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 grams (g) durvalumab and 75 milligrams (mg) tremelimumab via intravenous (IV) infusion every 4 weeks (q4w) over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48.~For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion."
11251011|NCT02558894|FG001|Participant Flow|Durvalumab (MEDI4736) Monotherapy|Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
11251012|NCT02558894|OG000|Outcome|Durvalumab (MEDI4736) Plus Tremelimumab|"Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48.~For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion."
11251013|NCT02558894|OG001|Outcome|Durvalumab (MEDI4736) Monotherapy|Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
11251014|NCT02558894|EG000|Reported Event|Durvalumab (MEDI4736) Plus Tremelimumab|"Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48.~For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion."
11251015|NCT02558894|EG001|Reported Event|Durvalumab (MEDI4736) Monotherapy|Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
11251016|NCT02559115|BG000|Baseline|PET/CT Imaging With 68Ga-RM2|"The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.~68Ga-RM2 (RM2)~PET/CT Scan"
11251017|NCT02559115|FG000|Participant Flow|PET/CT Imaging With 68Ga-RM2|"The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.~68Ga-RM2 (RM2)~PET/CT Scan"
11251018|NCT02559115|OG000|Outcome|PET/CT Imaging With 68Ga-RM2|"The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.~68Ga-RM2 (RM2)~PET/CT Scan"
11251019|NCT02559115|EG000|Reported Event|PET/CT Imaging With 68Ga-RM2|"The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.~68Ga-RM2 (RM2)~PET/CT Scan"
11251020|NCT02559206|BG000|Baseline|Placebo|Placebo: once daily (QD) for 12 weeks
11251021|NCT02559206|BG001|Baseline|Linaclotide IR 290 μg|Linaclotide IR formulation: 290 μg QD for 12 weeks
11251022|NCT02559206|BG002|Baseline|Linaclotide DR1 30 μg|Linaclotide DR1 30 μg QD for 12 weeks
11251023|NCT02559206|BG003|Baseline|Linaclotide DR1 100 μg|Linaclotide DR1 100 μg QD for 12 weeks
11251024|NCT02559206|BG004|Baseline|Linaclotide DR1 300 μg|Linaclotide DR1 300 μg QD for 12 weeks
11251025|NCT02559206|BG005|Baseline|Linaclotide DR2 30 μg|Linaclotide DR2 30 μg QD for 12 weeks
11251026|NCT02559206|BG006|Baseline|Linaclotide DR2 100 μg|Linaclotide DR2 100 μg QD for 12 weeks
10969858|NCT00907777|EG000|Reported Event|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
11251027|NCT02559206|BG007|Baseline|Linaclotide DR2 300 μg|Linaclotide DR2 300 μg QD for 12 weeks
11251028|NCT02559206|BG008|Baseline|Total|Total of all reporting groups
11251029|NCT02559206|FG000|Participant Flow|Placebo|Placebo: once daily (QD) for 12 weeks
11251030|NCT02559206|FG001|Participant Flow|Linaclotide IR 290 μg|Linaclotide immediate release (IR) formulation: 290 μg QD for 12 weeks
11251031|NCT02559206|FG002|Participant Flow|Linaclotide DR1 30 μg|Linaclotide delayed release formulation 1 (DR1) 30 μg QD for 12 weeks
10822093|NCT00074412|OG001|Outcome|Placebo|For infants: extended treatment with NVP placebo
10969859|NCT00907777|EG001|Reported Event|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
10969860|NCT00907803|BG000|Baseline|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
11251032|NCT02559206|FG003|Participant Flow|Linaclotide DR1 100 μg|Linaclotide DR1 100 μg QD for 12 weeks
11251033|NCT02559206|FG004|Participant Flow|Linaclotide DR1 300 μg|Linaclotide DR1 300 μg QD for 12 weeks
11251034|NCT02559206|FG005|Participant Flow|Linaclotide DR2 30 μg|Linaclotide delayed release formulation 2 (DR2) 30 μg QD for 12 weeks
11251035|NCT02559206|FG006|Participant Flow|Linaclotide DR2 100 μg|Linaclotide DR2 100 μg QD for 12 weeks
11251036|NCT02559206|FG007|Participant Flow|Linaclotide DR2 300 μg|Linaclotide DR2 300 μg QD for 12 weeks
11251037|NCT02559206|OG000|Outcome|Placebo|Placebo: QD for 12 weeks
11251038|NCT02559206|OG001|Outcome|Linaclotide IR 290 μg|Linaclotide IR formulation: 290 μg QD for 12 weeks
11251039|NCT02559206|OG002|Outcome|Linaclotide DR1 30 μg|Linaclotide DR1 30 μg QD for 12 weeks
11251040|NCT02559206|OG003|Outcome|Linaclotide DR1 100 μg|Linaclotide DR1 100 μg QD for 12 weeks
11251041|NCT02559206|OG004|Outcome|Linaclotide DR1 300 μg|Linaclotide DR1 300 μg QD for 12 weeks
11251042|NCT02559206|OG002|Outcome|Linaclotide DR2 30 μg|Linaclotide DR2 30 μg QD for 12 weeks
11251043|NCT02559206|OG003|Outcome|Linaclotide DR2 100 μg|Linaclotide DR2 100 μg QD for 12 weeks
11251044|NCT02559206|OG004|Outcome|Linaclotide DR2 300 μg|Linaclotide DR2 300 μg QD for 12 weeks
11251045|NCT02559206|EG000|Reported Event|Placebo|Placebo: QD for 12 weeks
11251046|NCT02559206|EG001|Reported Event|Linaclotide IR 290 μg|Linaclotide IR formulation: 290 μg QD for 12 weeks
11251047|NCT02559206|EG002|Reported Event|Linaclotide DR1 30 μg|Linaclotide DR1 30 μg QD for 12 weeks
11251048|NCT02559206|EG003|Reported Event|Linaclotide DR1 100 μg|Linaclotide DR1 100 μg QD for 12 weeks
11251049|NCT02559206|EG004|Reported Event|Linaclotide DR1 300 μg|Linaclotide DR1 300 μg QD for 12 weeks
11251050|NCT02559206|EG005|Reported Event|Linaclotide DR2 30 μg|Linaclotide DR2 30 μg QD for 12 weeks
11251051|NCT02559206|EG006|Reported Event|Linaclotide DR2 100 μg|Linaclotide DR2 100 μg QD for 12 weeks
11251052|NCT02559206|EG007|Reported Event|Linaclotide DR2 300 μg|Linaclotide DR2 300 μg QD for 12 weeks
11251053|NCT02559310|BG000|Baseline|Lefamulin|Lefamulin 150 mg IV q12h with option to switch to 600 mg PO q12h after at least 6 doses of IV treatment. Linezolid placebo q12h was added at baseline for patients with suspected MRSA.
11251054|NCT02559310|BG001|Baseline|Moxifloxacin ± Linezolid|Moxifloxacin 400 mg IV q24h with option to switch to 400 mg PO q24h after at least 6 doses of IV treatment. Linezolid 600 mg IV q12h was added at baseline for patients with suspected MRSA.
11251055|NCT02559310|BG002|Baseline|Total|Total of all reporting groups
11251056|NCT02559310|FG000|Participant Flow|Lefamulin|Lefamulin 150 mg IV q12h with option to switch to 600 mg PO q12h after at least 6 doses of IV treatment. Linezolid placebo q12h was added at baseline for patients with suspected MRSA.
11251057|NCT02559310|FG001|Participant Flow|Moxifloxacin ± Linezolid|Moxifloxacin 400 mg IV q24h with option to switch to 400 mg PO q24h after at least 6 doses of IV treatment. Linezolid 600 mg IV q12h was added at baseline for patients with suspected MRSA.
11251058|NCT02559310|OG000|Outcome|Lefamulin|Lefamulin 150 mg IV q12h with option to switch to 600 mg PO q12h after at least 6 doses of IV treatment. Linezolid placebo q12h was added at baseline for patients with suspected MRSA.
11251059|NCT02559310|OG001|Outcome|Moxifloxacin ± Linezolid|Moxifloxacin 400 mg IV q24h with option to switch to 400 mg PO q24h after at least 6 doses of IV treatment. Linezolid 600 mg IV q12h was added at baseline for patients with suspected MRSA.
11251060|NCT02559310|EG000|Reported Event|Lefamulin|Lefamulin 150 mg IV q12h with option to switch to 600 mg PO q12h after at least 6 doses of IV treatment. Linezolid placebo q12h was added at baseline for patients with suspected MRSA.
11251061|NCT02559310|EG001|Reported Event|Moxifloxacin ± Linezolid|Moxifloxacin 400 mg IV q24h with option to switch to 400 mg PO q24h after at least 6 doses of IV treatment. Linezolid 600 mg IV q12h was added at baseline for patients with suspected MRSA.
11251062|NCT02559414|BG000|Baseline|Control|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
11251063|NCT02559414|BG001|Baseline|Aspirin|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.~Aspirin"
11251064|NCT02559414|BG002|Baseline|Clopidogrel|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.~Clopidogrel"
11251065|NCT02559414|BG003|Baseline|Total|Total of all reporting groups
11251066|NCT02559414|FG000|Participant Flow|Control|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
11251067|NCT02559414|FG001|Participant Flow|Aspirin|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.~Aspirin"
11251068|NCT02559414|FG002|Participant Flow|Clopidogrel|"This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.~Clopidogrel"
11251069|NCT02559414|OG000|Outcome|Placebo Baseline|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
11251070|NCT02559414|OG001|Outcome|Placebo Follow up|
11251071|NCT02559414|OG002|Outcome|Aspirin Baseline|
11251072|NCT02559414|OG003|Outcome|Aspirin Randomization|
11251073|NCT02559414|OG004|Outcome|Clopidogrel Baseline|
11251074|NCT02559414|OG005|Outcome|Clopidogrel Randomization|
11251075|NCT02559414|OG000|Outcome|Placebo Baseline|
11251076|NCT02559414|OG003|Outcome|Aspirin Follow up|
11251077|NCT02559414|OG005|Outcome|Clopidogrel Follow up|
11251078|NCT02559414|EG000|Reported Event|Placebo Baseline|This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
11251079|NCT02559414|EG001|Reported Event|Placebo Follow up|
11251080|NCT02559414|EG002|Reported Event|Aspirin Baseline|
11251081|NCT02559414|EG003|Reported Event|Aspirin Randomization|
11251082|NCT02559414|EG004|Reported Event|Clopidogrel Baseline|
11251083|NCT02559414|EG005|Reported Event|Clopidogrel Randomization|
11251084|NCT02559505|BG000|Baseline|6-12 Months of Age: Vaccinated|"Children 6 - 12 months of age vaccinated with seasonal IIV~Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251085|NCT02559505|BG001|Baseline|3-12 Months of Age: Acute|"Children 3-12 months of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251086|NCT02559505|BG002|Baseline|13-35 Months of Age: Vaccinated|"Children 13-35 months of age vaccinated with seasonal IIV~Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251087|NCT02559505|BG003|Baseline|13-35 Months of Age: Acute|"Children 13-35 months of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251088|NCT02559505|BG004|Baseline|3-5 Years of Age: Vaccinated|"Children 3-5 years of age vaccinated with seasonal IIV~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251089|NCT02559505|BG005|Baseline|3-5 Years of Age: Acute|"Children 3-5 years of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251090|NCT02559505|BG006|Baseline|6-8 Years of Age: Vaccinated|"Children 6-8 years of age vaccinated with seasonal IIV~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251091|NCT02559505|BG007|Baseline|6-8 Years of Age: Acute|"Children 6-8 years of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251092|NCT02559505|BG008|Baseline|Total|Total of all reporting groups
11251093|NCT02559505|FG000|Participant Flow|Acute|Children enrolled on presentation to their primary care provider with a natural influenza infection.
11251094|NCT02559505|FG001|Participant Flow|Vaccinated|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
11251095|NCT02559505|OG000|Outcome|Acute Infected|Children enrolled on presentation to their primary care provider with a natural influenza infection
11251096|NCT02559505|OG001|Outcome|Vaccinated|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
11251097|NCT02559505|OG000|Outcome|Acute Infected|Children enrolled on presentation to their primary care provider with a natural influenza infection.
11251098|NCT02559505|OG001|Outcome|Vaccinated|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age.
11251099|NCT02559505|OG000|Outcome|Vaccinated Age Subset (6-12 mo)|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 12 months.
11251100|NCT02559505|OG001|Outcome|Vaccinated Age Subset (13-35 mo)|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 13 - 35 months.
11251101|NCT02559505|OG002|Outcome|Vaccinated Age Subset (3-5 yr)|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 3 - 5 years.
11251102|NCT02559505|OG003|Outcome|Vaccinated Age Subset (6-8 yr)|Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 8 years.
10822094|NCT00074412|EG000|Reported Event|Nevirapine|For infants: extended treatment with NVP
11251103|NCT02559505|EG000|Reported Event|6-12 Months: Vaccinated|"Children 6 - 12 months of age vaccinated with seasonal IIV~Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251104|NCT02559505|EG001|Reported Event|3-12 Months: Acute|"Children 3-12 months of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251105|NCT02559505|EG002|Reported Event|13-35 Months: Vaccinated|"Children 13-35 months of age vaccinated with seasonal IIV~Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251106|NCT02559505|EG003|Reported Event|13-35 Months: Acute|"Children 13-35 months of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251107|NCT02559505|EG004|Reported Event|3-5 Years: Vaccinated|"Children 3-5 years of age vaccinated with seasonal IIV~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251108|NCT02559505|EG005|Reported Event|3-5 Years: Acute|"Children 3-5 years of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251109|NCT02559505|EG006|Reported Event|6-8 Years: Vaccinated|"Children 6-8 years of age vaccinated with seasonal IIV~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251110|NCT02559505|EG007|Reported Event|6-8 Years: Acute|"Children 6-8 years of age presenting with natural influenza infection~Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection~Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age"
11251111|NCT02559570|BG000|Baseline|Placebo|Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
11251112|NCT02559570|BG001|Baseline|LIN Dose A (9 ug or 18 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
11251113|NCT02559570|BG002|Baseline|LIN Dose B (18 ug or 36 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251114|NCT02559570|BG003|Baseline|LIN Dose C (36 ug or 72 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251115|NCT02559570|BG004|Baseline|LIN 145 µg|Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251116|NCT02559570|BG005|Baseline|Total|Total of all reporting groups
11251117|NCT02559570|FG000|Participant Flow|Placebo|Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
11251118|NCT02559570|FG001|Participant Flow|LIN Dose A (9 ug or 18 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
11251119|NCT02559570|FG002|Participant Flow|LIN Dose B (18 ug or 36 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251120|NCT02559570|FG003|Participant Flow|LIN Dose C (36 ug or 72 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251121|NCT02559570|FG004|Participant Flow|LIN 145 µg|Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251122|NCT02559570|OG000|Outcome|Placebo|Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
11251123|NCT02559570|OG001|Outcome|LIN Dose A (9 ug or 18 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
11251124|NCT02559570|OG002|Outcome|LIN Dose B (18 ug or 36 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251125|NCT02559570|OG003|Outcome|LIN Dose C (36 ug or 72 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251126|NCT02559570|EG000|Reported Event|Placebo|Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
11251127|NCT02559570|EG001|Reported Event|LIN Dose A (9 ug or 18 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks
11251128|NCT02559570|EG002|Reported Event|LIN Dose B (18 ug or 36 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251129|NCT02559570|EG003|Reported Event|LIN Dose C (36 ug or 72 ug)|Participants aged 6 to 11 years with weight 18 to <35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251130|NCT02559570|EG004|Reported Event|LIN 145 µg|Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
11251131|NCT02559622|BG000|Baseline|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251132|NCT02559622|BG001|Baseline|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251133|NCT02559622|BG002|Baseline|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251134|NCT02559622|BG003|Baseline|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251135|NCT02559622|BG004|Baseline|Total|Total of all reporting groups
11251136|NCT02559622|FG000|Participant Flow|Secukinumab 300 mg|Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251137|NCT02559622|FG001|Participant Flow|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251138|NCT02559622|FG002|Participant Flow|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251139|NCT02559622|FG003|Participant Flow|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251140|NCT02559622|OG000|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251141|NCT02559622|OG001|Outcome|Placebo (Pooled)|Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).
11251142|NCT02559622|OG001|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251143|NCT02559622|OG002|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251144|NCT02559622|OG003|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251145|NCT02559622|EG000|Reported Event|Secukinumab (300 mg) up to Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.
11251146|NCT02559622|EG001|Reported Event|Secukinumab (150 mg) up to Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.
11251147|NCT02559622|EG002|Reported Event|Placebo up to Week 12|Participants were administered with placebo up to 12 weeks.
11251148|NCT02559622|EG003|Reported Event|Secukinumab (300 mg) After Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251149|NCT02559622|EG004|Reported Event|Secukinumab (150 mg) After Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251150|NCT02559622|EG005|Reported Event|Placebo Followed by Secukinumab (300 mg) After Week 12|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
11251151|NCT02559622|EG006|Reported Event|Placebo Followed by Secukinumab (150 mg) After Week 12|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
11251152|NCT02559687|BG000|Baseline|Pembrolizumab 200 mg|Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
11251153|NCT02559687|FG000|Participant Flow|Pembrolizumab 200 mg|Participants receive pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W) for up to 35 treatments (approximately 2 years).
11251154|NCT02559687|OG000|Outcome|Pembrolizumab 200 mg|Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
11251155|NCT02559687|EG000|Reported Event|Pembrolizumab 200 mg|Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
11251156|NCT02559713|BG000|Baseline|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
11251157|NCT02559713|FG000|Participant Flow|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
11251158|NCT02559713|OG000|Outcome|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
10822095|NCT00074412|EG001|Reported Event|Placebo|For infants: extended treatment with NVP placebo
11251159|NCT02559713|EG000|Reported Event|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
11251160|NCT02559817|BG000|Baseline|Matching Placebo|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast~Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age~Placebo solid oral capsule in children 12-17 years of age"
11251161|NCT02559817|BG001|Baseline|Linaclotide Dose A|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose A: 36 micrograms solid oral capsule in children 12-17 years of age"
11251162|NCT02559817|BG002|Baseline|Linaclotide Dose B|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose B: 72 micrograms solid oral capsule in children 12-17 years of age"
11251163|NCT02559817|BG003|Baseline|Linaclotide Dose C|"Taken once daily each evening, at least 30 minutes before their evening meal,, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose C: 145 micrograms solid oral capsule in children 12-17 years of age"
11251164|NCT02559817|BG004|Baseline|Linaclotide Approved Adult Dose|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age"
11251165|NCT02559817|BG005|Baseline|Total|Total of all reporting groups
11251166|NCT02559817|FG000|Participant Flow|Matching Placebo|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast~Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age~Placebo solid oral capsule in children 12-17 years of age"
11251167|NCT02559817|FG001|Participant Flow|Linaclotide Dose A|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose A: 36 micrograms solid oral capsule in children 12-17 years of age"
11251168|NCT02559817|FG002|Participant Flow|Linaclotide Dose B|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose B: 72 micrograms solid oral capsule in children 12-17 years of age"
11251169|NCT02559817|FG003|Participant Flow|Linaclotide Dose C|"Taken once daily each evening, at least 30 minutes before their evening meal,, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose C: 145 micrograms solid oral capsule in children 12-17 years of age"
11251170|NCT02559817|FG004|Participant Flow|Linaclotide Approved Adult Dose|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age"
11251171|NCT02559817|OG000|Outcome|Matching Placebo|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast~Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age~Placebo solid oral capsule in children 12-17 years of age"
11251172|NCT02559817|OG001|Outcome|Linaclotide Dose A|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose A: 36 micrograms solid oral capsule in children 12-17 years of age"
11251173|NCT02559817|OG002|Outcome|Linaclotide Dose B|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose B: 72 micrograms solid oral capsule in children 12-17 years of age"
11251174|NCT02559817|OG003|Outcome|Linaclotide Dose C|"Taken once daily each evening, at least 30 minutes before their evening meal,, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose C: 145 micrograms solid oral capsule in children 12-17 years of age"
11251175|NCT02559817|OG004|Outcome|Linaclotide Approved Adult Dose|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age"
11251176|NCT02559817|EG000|Reported Event|Matching Placebo|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast~Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age~Placebo solid oral capsule in children 12-17 years of age"
11251177|NCT02559817|EG001|Reported Event|Linaclotide Dose A|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose A: 36 micrograms solid oral capsule in children 12-17 years of age"
11251178|NCT02559817|EG002|Reported Event|Linaclotide Dose B|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose B: 72 micrograms solid oral capsule in children 12-17 years of age"
11251179|NCT02559817|EG003|Reported Event|Linaclotide Dose C|"Taken once daily each evening, at least 30 minutes before their evening meal,, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg~Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg~Dose C: 145 micrograms solid oral capsule in children 12-17 years of age"
11251180|NCT02559817|EG004|Reported Event|Linaclotide Approved Adult Dose|"Taken once daily each evening, at least 30 minutes before their evening meal, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.~Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age"
11251181|NCT02559895|BG000|Baseline|300 mg ALD403|Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251182|NCT02559895|BG001|Baseline|100 mg ALD403|Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251183|NCT02559895|BG002|Baseline|30 mg ALD403|Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251184|NCT02559895|BG003|Baseline|Placebo|Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251185|NCT02559895|BG004|Baseline|Total|Total of all reporting groups
11251186|NCT02559895|FG000|Participant Flow|300 mg ALD403|Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251187|NCT02559895|FG001|Participant Flow|100 mg ALD403|Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251188|NCT02559895|FG002|Participant Flow|30 mg ALD403|Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251189|NCT02559895|FG003|Participant Flow|Placebo|Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251190|NCT02559895|OG000|Outcome|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251191|NCT02559895|OG001|Outcome|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251192|NCT02559895|OG002|Outcome|30 mg ALD403|Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251193|NCT02559895|OG003|Outcome|Placebo|Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251194|NCT02559895|EG000|Reported Event|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251195|NCT02559895|EG001|Reported Event|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251196|NCT02559895|EG002|Reported Event|30 mg ALD403|Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251197|NCT02559895|EG003|Reported Event|Placebo|Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
11251198|NCT02560012|BG000|Baseline|Personalized Therapy|"Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off~Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week~Sorafenib: 400 mg (2 tablets) orally twice daily without food~Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal~Everolimus: 10 mg orally once daily with or without food~Axitinib: 5 mg orally twice"
11251199|NCT02560012|FG000|Participant Flow|Personalized Therapy|"Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off~Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week~Sorafenib: 400 mg (2 tablets) orally twice daily without food~Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal~Everolimus: 10 mg orally once daily with or without food~Axitinib: 5 mg orally twice"
11251200|NCT02560012|OG000|Outcome|Personalized Therapy|"Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off~Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week~Sorafenib: 400 mg (2 tablets) orally twice daily without food~Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal~Everolimus: 10 mg orally once daily with or without food~Axitinib: 5 mg orally twice"
11251201|NCT02560012|EG000|Reported Event|Personalized Therapy|"Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.~Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off~Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week~Sorafenib: 400 mg (2 tablets) orally twice daily without food~Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal~Everolimus: 10 mg orally once daily with or without food~Axitinib: 5 mg orally twice"
11251202|NCT02560025|BG000|Baseline|Alisertib / MLN8237|"Participants will initially receive 7+3 induction chemotherapy, consisting of cytarabine and concurrent idarubicin (or daunorubicin if appropriate). Oral alisertib, at 30mg twice daily, will begin on day 8, and will continue for 7 days. During induction, patients with residual disease at day 14 may have re-induction with 5+2 chemotherapy, but will not receive additional dosing of alisertib at that time. Following count recovery after induction, if patients proceed to consolidative cycles of therapy with cytarabine, they will receive alisertib at day 6 following conclusion of cytarabine administration. Upon count recovery following consolidation, alisertib will be resumed for 7 days, followed by 14 days off, and will be continued as 21-day cycles of maintenance, for up to 12 cycles."
11251203|NCT02560025|FG000|Participant Flow|Alisertib / MLN8237|"Participants will initially receive 7+3 induction chemotherapy, consisting of cytarabine and concurrent idarubicin (or daunorubicin if appropriate). Oral alisertib, at 30mg twice daily, will begin on day 8, and will continue for 7 days. During induction, patients with residual disease at day 14 may have re-induction with 5+2 chemotherapy, but will not receive additional dosing of alisertib at that time. Following count recovery after induction, if patients proceed to consolidative cycles of therapy with cytarabine, they will receive alisertib at day 6 following conclusion of cytarabine administration. Upon count recovery following consolidation, alisertib will be resumed for 7 days, followed by 14 days off, and will be continued as 21-day cycles of maintenance, for up to 12 cycles."
11251204|NCT02560025|OG000|Outcome|Alisertib / MLN8237|"Participants will initially receive 7+3 induction chemotherapy, consisting of cytarabine and concurrent idarubicin (or daunorubicin if appropriate). Oral alisertib, at 30mg twice daily, will begin on day 8, and will continue for 7 days. During induction, patients with residual disease at day 14 may have re-induction with 5+2 chemotherapy, but will not receive additional dosing of alisertib at that time. Following count recovery after induction, if patients proceed to consolidative cycles of therapy with cytarabine, they will receive alisertib at day 6 following conclusion of cytarabine administration. Upon count recovery following consolidation, alisertib will be resumed for 7 days, followed by 14 days off, and will be continued as 21-day cycles of maintenance, for up to 12 cycles."
11251205|NCT02560025|EG000|Reported Event|Alisertib / MLN8237|"Participants will initially receive 7+3 induction chemotherapy, consisting of cytarabine and concurrent idarubicin (or daunorubicin if appropriate). Oral alisertib, at 30mg twice daily, will begin on day 8, and will continue for 7 days. During induction, patients with residual disease at day 14 may have re-induction with 5+2 chemotherapy, but will not receive additional dosing of alisertib at that time. Following count recovery after induction, if patients proceed to consolidative cycles of therapy with cytarabine, they will receive alisertib at day 6 following conclusion of cytarabine administration. Upon count recovery following consolidation, alisertib will be resumed for 7 days, followed by 14 days off, and will be continued as 21-day cycles of maintenance, for up to 12 cycles."
11251206|NCT02560038|BG000|Baseline|Combination Chemotherapy|"Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle.~Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).~Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).~Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days)."
11251207|NCT02560038|FG000|Participant Flow|Combination Chemotherapy|"Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle.~Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).~Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).~Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days)."
11251208|NCT02560038|OG000|Outcome|Combination Chemotherapy|"Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle.~Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).~Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).~Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days)."
11251209|NCT02560038|EG000|Reported Event|Combination Chemotherapy|"Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle.~Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).~Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).~Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days)."
11251210|NCT02560051|BG000|Baseline|Definitive Local Therapy|"3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251211|NCT02560051|BG001|Baseline|Nodal Only/Low-volume Bone|"4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251212|NCT02560051|BG002|Baseline|High Volume/no Prior tx|"5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251213|NCT02560051|BG003|Baseline|Total|Total of all reporting groups
11251214|NCT02560051|FG000|Participant Flow|Definitive Local Therapy|"3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251215|NCT02560051|FG001|Participant Flow|Nodal Only/Low-volume Bone|"4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251216|NCT02560051|FG002|Participant Flow|High Volume/no Prior tx|"5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251217|NCT02560051|OG000|Outcome|Definitive Local Therapy|"3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251218|NCT02560051|OG001|Outcome|Nodal Only/Low-volume Bone|"4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251219|NCT02560051|OG002|Outcome|High Volume/no Prior tx|"5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251220|NCT02560051|EG000|Reported Event|Definitive Local Therapy|"3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251221|NCT02560051|EG001|Reported Event|Nodal Only/Low-volume Bone|"4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251222|NCT02560051|EG002|Reported Event|High Volume/no Prior tx|"5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)~Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)~Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)~Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)~Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)~Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days"
11251223|NCT02560324|BG000|Baseline|Ramelteon Then Placebo|Participants smoked ad libitum for 1 week and then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
11251224|NCT02560324|BG001|Baseline|Placebo Then Ramelteon|Participants smoked ad libitum for 1 week and then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
11251225|NCT02560324|BG002|Baseline|Total|Total of all reporting groups
11251226|NCT02560324|FG000|Participant Flow|Ramelteon Then Placebo|Participants smoked ad libitum for 1 week and then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
11251227|NCT02560324|FG001|Participant Flow|Placebo Then Ramelteon|Participants smoked ad libitum for 1 week and then received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week. After a washout period of 2 weeks, participants again smoked ad libitum for 1 week, then received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
11251228|NCT02560324|OG000|Outcome|Ramelteon|Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
11251229|NCT02560324|OG001|Outcome|Placebo|Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
11251230|NCT02560324|OG000|Outcome|Ramelteon (Baseline)|Before participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
11251231|NCT02560324|OG001|Outcome|Placebo (Baseline)|Before participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
11251232|NCT02560324|OG002|Outcome|Ramelteon (Quit Week)|Participants received 8mg of Ramelteon once per day + transdermal nicotine for 1 week.
11251233|NCT02560324|OG003|Outcome|Placebo (Quit Week)|Participants received Placebo pills (matching Ramelteon 8mg pills) once per day + transdermal nicotine for 1 week.
11251234|NCT02560324|EG000|Reported Event|Ramelteon|Participants received medication (8mg of Ramelteon) once per day + transdermal nicotine for 1 week.
11251235|NCT02560324|EG001|Reported Event|Placebo|Participants received Placebo once per day + transdermal nicotine for 1 week.
11251236|NCT02560389|BG000|Baseline|Placebo|"Placebo administered in pill form once by mouth~Placebo: Sugar pill packaged to resemble levodopa"
11251237|NCT02560389|BG001|Baseline|100mg L-DOPA|"100mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251238|NCT02560389|BG002|Baseline|200mg L-DOPA|"200mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251239|NCT02560389|BG003|Baseline|Total|Total of all reporting groups
11251240|NCT02560389|FG000|Participant Flow|Placebo|"Placebo administered in pill form once by mouth~Placebo: Sugar pill packaged to resemble levodopa"
11251241|NCT02560389|FG001|Participant Flow|100mg L-DOPA|"100mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251242|NCT02560389|FG002|Participant Flow|200mg L-DOPA|"200mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251243|NCT02560389|OG000|Outcome|Placebo|"Placebo administered in pill form once by mouth~Placebo: Sugar pill packaged to resemble levodopa"
11251244|NCT02560389|OG001|Outcome|100mg L-DOPA|"100mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251245|NCT02560389|OG002|Outcome|200mg L-DOPA|"200mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251246|NCT02560389|EG000|Reported Event|Placebo|"Placebo administered in pill form once by mouth~Placebo: Sugar pill packaged to resemble levodopa"
11251247|NCT02560389|EG001|Reported Event|100mg L-DOPA|"100mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251248|NCT02560389|EG002|Reported Event|200mg L-DOPA|"200mg levodopa administered in pill form once by mouth~Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth."
11251249|NCT02560493|BG000|Baseline|Control Condition|Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
11251250|NCT02560493|BG001|Baseline|Exergaming Condition|"Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.~Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines."
11251251|NCT02560493|BG002|Baseline|Total|Total of all reporting groups
11251252|NCT02560493|FG000|Participant Flow|Control Condition|Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
11251253|NCT02560493|FG001|Participant Flow|Exergaming Condition|"Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.~Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines."
11251254|NCT02560493|OG000|Outcome|Control Condition|Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
11251255|NCT02560493|OG001|Outcome|Exergaming Condition|"Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.~Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines."
11251256|NCT02560493|EG000|Reported Event|Control Condition|Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
11251257|NCT02560493|EG001|Reported Event|Exergaming Condition|"Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.~Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines."
11251258|NCT02560558|BG000|Baseline|Belatacept 8-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251259|NCT02560558|BG001|Baseline|Belatacept 4-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251260|NCT02560558|BG002|Baseline|Total|Total of all reporting groups
11251261|NCT02560558|FG000|Participant Flow|Belatacept 8-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251262|NCT02560558|FG001|Participant Flow|Belatacept 4-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251263|NCT02560558|OG000|Outcome|Belatacept 8-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251264|NCT02560558|OG001|Outcome|Belatacept 4-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251265|NCT02560558|EG000|Reported Event|Belatacept 8-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251266|NCT02560558|EG001|Reported Event|Belatacept 4-weekly|"Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.~Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals."
11251267|NCT02560584|BG000|Baseline|Cysview Arm|"In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)~All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.~Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System"
11251268|NCT02560584|FG000|Participant Flow|Cysview Arm|"In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)~All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.~Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System"
11251269|NCT02560584|OG000|Outcome|Cysview Arm|"In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)~All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.~Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System"
11251270|NCT02560584|OG000|Outcome|Surveillance Examination|Patients who received Cysview instillation in the surveillance examination.
11251271|NCT02560584|OG001|Outcome|Surveillance + OR Examination|Patients who received a Cysview instillation in both surveillance and OR examinations.
11251272|NCT02560584|EG000|Reported Event|Cysview Arm|"In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)~All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.~Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System"
11251273|NCT02560701|BG000|Baseline|High-Deductible Health Plan Group|Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
11251274|NCT02560701|BG001|Baseline|Control Group|Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
11251275|NCT02560701|BG002|Baseline|Total|Total of all reporting groups
11251276|NCT02560701|FG000|Participant Flow|High-Deductible Health Plan Group|Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
11251277|NCT02560701|FG001|Participant Flow|Control Group|Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
11251278|NCT02560701|OG000|Outcome|High-Deductible Health Plan Group|Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
11251279|NCT02560701|OG001|Outcome|Control Group|Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
11251280|NCT02560701|EG000|Reported Event|High-Deductible Health Plan Group|Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
11251281|NCT02560701|EG001|Reported Event|Control Group|Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
11251282|NCT02560753|BG000|Baseline|T3D-959 3mg|"subjects took 3mg by mouth once daily for two weeks, with or without food.~T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)"
11251283|NCT02560753|BG001|Baseline|T3D-959 10mg|"subjects took 10mg by mouth once daily for two weeks, with or without food.~The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)"
11251284|NCT02560753|BG002|Baseline|T3D-959 30mg|"subjects took 30mg by mouth once daily for two weeks, with or without food.~The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)"
11251285|NCT02560753|BG003|Baseline|T3D-959 90mg|"subjects took 90mg by mouth once daily for two weeks, with or without food.~The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)"
11251286|NCT02560753|BG004|Baseline|Total|Total of all reporting groups
11251287|NCT02560753|FG000|Participant Flow|T3D-959 3mg|"subjects took 3mg by mouth once daily for two weeks, with or without food.~T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)"
11251288|NCT02560753|FG001|Participant Flow|T3D-959 10mg|"subjects took 10mg by mouth once daily for two weeks, with or without food.~The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)"
11251289|NCT02560753|FG002|Participant Flow|T3D-959 30mg|"subjects took 30mg by mouth once daily for two weeks, with or without food.~The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)"
11251290|NCT02560753|FG003|Participant Flow|T3D-959 90mg|"subjects took 90mg by mouth once daily for two weeks, with or without food.~The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)"
11251291|NCT02560753|OG000|Outcome|T3D-959 3mg|"subjects took 3mg by mouth once daily for two weeks, with or without food.~T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)"
11251292|NCT02560753|OG001|Outcome|T3D-959 10mg|"subjects took 10mg by mouth once daily for two weeks, with or without food.~The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)"
11251293|NCT02560753|OG002|Outcome|T3D-959 30mg|"subjects took 30mg by mouth once daily for two weeks, with or without food.~The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)"
11251294|NCT02560753|OG003|Outcome|T3D-959 90mg|"subjects took 90mg by mouth once daily for two weeks, with or without food.~The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)"
11251295|NCT02560753|EG000|Reported Event|T3D-959 3mg|"subjects took 3mg by mouth once daily for two weeks, with or without food.~T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)"
11251296|NCT02560753|EG001|Reported Event|T3D-959 10mg|"subjects took 10mg by mouth once daily for two weeks, with or without food.~The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)"
11251297|NCT02560753|EG002|Reported Event|T3D-959 30mg|"subjects took 30mg by mouth once daily for two weeks, with or without food.~The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)"
11251298|NCT02560753|EG003|Reported Event|T3D-959 90mg|"subjects took 90mg by mouth once daily for two weeks, with or without food.~The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)"
11251299|NCT02560779|BG000|Baseline|Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib|Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
11251300|NCT02560779|BG001|Baseline|Carotuximab (10 mg/kg Weekly) Plus Sorafenib|Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
11251301|NCT02560779|BG002|Baseline|Total|Total of all reporting groups
11251302|NCT02560779|FG000|Participant Flow|Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib|Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
11251303|NCT02560779|FG001|Participant Flow|Carotuximab (10 mg/kg Weekly) Plus Sorafenib|Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
11251304|NCT02560779|OG000|Outcome|Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib|Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
11251305|NCT02560779|OG001|Outcome|Carotuximab (10 mg/kg Weekly) Plus Sorafenib|Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
11251306|NCT02560779|EG000|Reported Event|Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib|Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
11251307|NCT02560779|EG001|Reported Event|Carotuximab (10 mg/kg Weekly) Plus Sorafenib|Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
11251308|NCT02560922|BG000|Baseline|Pain Coping Skills Training|"This group will take part in an 11-week pain coping skills training (CST) intervention.~Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management."
11251309|NCT02560922|BG001|Baseline|Wait List Control|The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
11251310|NCT02560922|BG002|Baseline|Total|Total of all reporting groups
11251311|NCT02560922|FG000|Participant Flow|Pain Coping Skills Training|"This group will take part in an 11-week pain coping skills training (CST) intervention.~Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management."
11251312|NCT02560922|FG001|Participant Flow|Wait List Control|The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
11251313|NCT02560922|OG000|Outcome|Pain Coping Skills Training|"This group will take part in an 11-week pain coping skills training (CST) intervention.~Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management."
11251314|NCT02560922|OG001|Outcome|Wait List Control|The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
11251315|NCT02560922|EG000|Reported Event|Pain Coping Skills Training|"This group will take part in an 11-week pain coping skills training (CST) intervention.~Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management."
11251316|NCT02560922|EG001|Reported Event|Wait List Control|The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
11251317|NCT02561000|BG000|Baseline|Placebo|"Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~Placebo"
11251318|NCT02561000|BG001|Baseline|PZ-128 0.3 mg/kg|"PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251319|NCT02561000|BG002|Baseline|PZ-128 0.5 mg/kg|"PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251320|NCT02561000|BG003|Baseline|Total|Total of all reporting groups
11251321|NCT02561000|FG000|Participant Flow|Placebo|"Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~Placebo"
11251322|NCT02561000|FG001|Participant Flow|PZ-128 0.3 mg/kg|"PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251323|NCT02561000|FG002|Participant Flow|PZ-128 0.5 mg/kg|"PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251324|NCT02561000|OG000|Outcome|Placebo|"Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~Placebo"
11251325|NCT02561000|OG001|Outcome|PZ-128 0.3 mg/kg|"PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251326|NCT02561000|OG002|Outcome|PZ-128 0.5 mg/kg|"PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251327|NCT02561000|EG000|Reported Event|Placebo|"Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~Placebo"
11251328|NCT02561000|EG001|Reported Event|PZ-128 0.3 mg/kg|"PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251329|NCT02561000|EG002|Reported Event|PZ-128 0.5 mg/kg|"PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion~PZ-128"
11251330|NCT02561078|BG000|Baseline|Human Regular U-500 Insulin Administered by CSII|Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.
11251331|NCT02561078|BG001|Baseline|Human Regular U-500 Insulin Administered by MDI|Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.
11251332|NCT02561078|BG002|Baseline|Total|Total of all reporting groups
11251333|NCT02561078|FG000|Participant Flow|Human Regular U-500 Insulin Administered by CSII|Human regular U-500 insulin administered by continuous subcutaneous insulin infusion (CSII) and titrated based on blood glucose readings for 26 weeks with a 2-week multiple daily injections (MDI) lead-in.
11251334|NCT02561078|FG001|Participant Flow|Human Regular U-500 Insulin Administered by MDI|Human regular U-500 insulin administered subcutaneously (SC) by multiple daily injections (MDI) three times a day and titrated based on blood glucose readings for 26 weeks.
11251335|NCT02561078|OG000|Outcome|Human Regular U-500 Insulin Administered by CSII|Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.
11251336|NCT02561078|OG001|Outcome|Human Regular U-500 Insulin Administered by MDI|Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.
11251337|NCT02561078|EG000|Reported Event|Human Regular U-500 Insulin Administered by CSII|Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.
11251338|NCT02561078|EG001|Reported Event|Human Regular U-500 Insulin Administered by MDI|Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.
11251339|NCT02561130|BG000|Baseline|Intervention|"Drug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise~insulin glargine: Dose is titrated to achieve fasting normoglycemia~metformin: Dose is titrated to 1 g bid or maximal tolerated dose~Forxiga: Dose is titrated to 10 mg po daily or maximal tolerated dose~Lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11251340|NCT02561130|BG001|Baseline|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11251341|NCT02561130|BG002|Baseline|Total|Total of all reporting groups
11251342|NCT02561130|FG000|Participant Flow|Intervention|"Drug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise~insulin glargine: Dose is titrated to achieve fasting normoglycemia~metformin: Dose is titrated to 1 g bid or maximal tolerated dose~Forxiga: Dose is titrated to 10 mg po daily or maximal tolerated dose~Lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11251343|NCT02561130|FG001|Participant Flow|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11251344|NCT02561130|OG000|Outcome|Intervention|"Drug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise~insulin glargine: Dose is titrated to achieve fasting normoglycemia~metformin: Dose is titrated to 1 g bid or maximal tolerated dose~Forxiga: Dose is titrated to 10 mg po daily or maximal tolerated dose~Lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11251345|NCT02561130|OG001|Outcome|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11251346|NCT02561130|EG000|Reported Event|Intervention|"Drug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise~insulin glargine: Dose is titrated to achieve fasting normoglycemia~metformin: Dose is titrated to 1 g bid or maximal tolerated dose~Forxiga: Dose is titrated to 10 mg po daily or maximal tolerated dose~Lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving"
11251347|NCT02561130|EG001|Reported Event|Standard Care|Standard glycemic care as informed by the current clinical practice guidelines
11251348|NCT02561156|BG000|Baseline|Part 1 Cohorts 1-6: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
11251349|NCT02561156|BG001|Baseline|Part 1 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
11251350|NCT02561156|BG002|Baseline|Part 1 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
11251351|NCT02561156|BG003|Baseline|Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg|TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
11251352|NCT02561156|BG004|Baseline|Part 1 Cohort 4: TAK-653 5 mg|TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
11251353|NCT02561156|BG005|Baseline|Part 1 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
11251354|NCT02561156|BG006|Baseline|Part 1 Cohort 6: TAK-653 18 mg|TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
11251355|NCT02561156|BG007|Baseline|Part 2 Cohorts 1-5: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251356|NCT02561156|BG008|Baseline|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251357|NCT02561156|BG009|Baseline|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251358|NCT02561156|BG010|Baseline|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251359|NCT02561156|BG011|Baseline|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251360|NCT02561156|BG012|Baseline|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251361|NCT02561156|BG013|Baseline|Total|Total of all reporting groups
11251362|NCT02561156|FG000|Participant Flow|Part 1 Cohorts 1-6: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
11251363|NCT02561156|FG001|Participant Flow|Part 1 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
11251364|NCT02561156|FG002|Participant Flow|Part 1 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
11251365|NCT02561156|FG003|Participant Flow|Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg|TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
11251366|NCT02561156|FG004|Participant Flow|Part 1 Cohort 4: TAK-653 5 mg|TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
11251367|NCT02561156|FG005|Participant Flow|Part 1 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
11251368|NCT02561156|FG006|Participant Flow|Part 1 Cohort 6: TAK-653 18 mg|TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
11251369|NCT02561156|FG007|Participant Flow|Part 2 Cohorts 1-5: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251370|NCT02561156|FG008|Participant Flow|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251371|NCT02561156|FG009|Participant Flow|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251372|NCT02561156|FG010|Participant Flow|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251373|NCT02561156|FG011|Participant Flow|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251374|NCT02561156|FG012|Participant Flow|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251375|NCT02561156|OG000|Outcome|Part 1 Cohorts 1-6: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
11251376|NCT02561156|OG001|Outcome|Part 1 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
11251377|NCT02561156|OG002|Outcome|Part 1 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
11251378|NCT02561156|OG003|Outcome|Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg|TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
11251379|NCT02561156|OG004|Outcome|Part 1 Cohort 4: TAK-653 5 mg|TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
11251380|NCT02561156|OG005|Outcome|Part 1 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
11251381|NCT02561156|OG006|Outcome|Part 1 Cohort 6: TAK-653 18 mg|TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
11251382|NCT02561156|OG000|Outcome|Part 2 Cohorts 1-5: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251383|NCT02561156|OG001|Outcome|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251384|NCT02561156|OG002|Outcome|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251385|NCT02561156|OG003|Outcome|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251386|NCT02561156|OG004|Outcome|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251387|NCT02561156|OG005|Outcome|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251388|NCT02561156|OG000|Outcome|Part 1 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
11251389|NCT02561156|OG001|Outcome|Part 1 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
11251390|NCT02561156|OG002|Outcome|Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg|TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
11251391|NCT02561156|OG003|Outcome|Part 1 Cohort 4: TAK-653 5 mg|TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
11251392|NCT02561156|OG004|Outcome|Part 1 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
11251393|NCT02561156|OG005|Outcome|Part 1 Cohort 6: TAK-653 18 mg|TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
11251394|NCT02561156|OG006|Outcome|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251395|NCT02561156|OG007|Outcome|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251396|NCT02561156|OG008|Outcome|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251397|NCT02561156|OG009|Outcome|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251398|NCT02561156|OG010|Outcome|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251399|NCT02561156|OG000|Outcome|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251400|NCT02561156|OG001|Outcome|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251401|NCT02561156|OG002|Outcome|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251402|NCT02561156|OG003|Outcome|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251403|NCT02561156|OG004|Outcome|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251404|NCT02561156|EG000|Reported Event|Part 1 Cohorts 1-6: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
11251405|NCT02561156|EG001|Reported Event|Part 1 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
11251406|NCT02561156|EG002|Reported Event|Part 1 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
11251407|NCT02561156|EG003|Reported Event|Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg|TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
11251408|NCT02561156|EG004|Reported Event|Part 1 Cohort 4: TAK-653 5 mg|TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
11251409|NCT02561156|EG005|Reported Event|Part 1 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
11251410|NCT02561156|EG006|Reported Event|Part 1 Cohort 6: TAK-653 18 mg|TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
11251411|NCT02561156|EG007|Reported Event|Part 2 Cohorts 1-5: Pooled Placebo|TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251412|NCT02561156|EG008|Reported Event|Part 2 Cohort 1: TAK-653 0.3 mg|TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251413|NCT02561156|EG009|Reported Event|Part 2 Cohort 2: TAK-653 1 mg|TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251414|NCT02561156|EG010|Reported Event|Part 2 Cohort 3: TAK-653 3 mg|TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251415|NCT02561156|EG011|Reported Event|Part 2 Cohort 4: TAK-653 6 mg|TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251416|NCT02561156|EG012|Reported Event|Part 2 Cohort 5: TAK-653 9 mg|TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
11251417|NCT02561195|BG000|Baseline|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
11251418|NCT02561195|BG001|Baseline|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251419|NCT02561195|BG002|Baseline|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251420|NCT02561195|BG003|Baseline|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
11251421|NCT02561195|BG004|Baseline|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251422|NCT02561195|BG005|Baseline|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251423|NCT02561195|BG006|Baseline|Total|Total of all reporting groups
11251424|NCT02561195|FG000|Participant Flow|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 microgram (mcg) of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251425|NCT02561195|FG001|Participant Flow|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251426|NCT02561195|FG002|Participant Flow|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251427|NCT02561195|FG003|Participant Flow|Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
11251428|NCT02561195|FG004|Participant Flow|Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251429|NCT02561195|FG005|Participant Flow|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251430|NCT02561195|FG006|Participant Flow|100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251431|NCT02561195|FG007|Participant Flow|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251432|NCT02561195|FG008|Participant Flow|200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251433|NCT02561195|FG009|Participant Flow|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251434|NCT02561195|FG010|Participant Flow|100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251435|NCT02561195|FG011|Participant Flow|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251436|NCT02561195|FG012|Participant Flow|200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251437|NCT02561195|FG013|Participant Flow|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251438|NCT02561195|OG000|Outcome|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251439|NCT02561195|OG001|Outcome|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
11251440|NCT02561195|OG002|Outcome|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251441|NCT02561195|OG000|Outcome|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251442|NCT02561195|OG001|Outcome|Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
11251443|NCT02561195|OG002|Outcome|Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251444|NCT02561195|OG000|Outcome|100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251445|NCT02561195|OG001|Outcome|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251446|NCT02561195|OG002|Outcome|200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251447|NCT02561195|OG003|Outcome|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251448|NCT02561195|OG001|Outcome|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251449|NCT02561195|OG000|Outcome|100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251450|NCT02561195|OG001|Outcome|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251451|NCT02561195|OG002|Outcome|200mcg Clostridium Difficile Vaccine to Placebo:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251452|NCT02561195|OG003|Outcome|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251453|NCT02561195|OG000|Outcome|100mcg Clostridium Difficile Vaccine to Placebo:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251454|NCT02561195|EG000|Reported Event|Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination
11251455|NCT02561195|EG001|Reported Event|Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251456|NCT02561195|EG002|Reported Event|Placebo: Day 1, 8 and 30 Regimen|Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination.
11251457|NCT02561195|EG003|Reported Event|Clostridium Difficile Vaccine(100 mcg): Month 0, 1 and 6 Regimen|Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination.
11251458|NCT02561195|EG004|Reported Event|Clostridium Difficile Vaccine(200 mcg): Month 0, 1 and 6 Regimen|Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251459|NCT02561195|EG005|Reported Event|Placebo: Month 0, 1 and 6 Regimen|Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination.
11251460|NCT02561195|EG006|Reported Event|100mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251461|NCT02561195|EG007|Reported Event|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received a fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251462|NCT02561195|EG008|Reported Event|200mcg Clostridium Difficile Vaccine to Placebo:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251463|NCT02561195|EG009|Reported Event|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251464|NCT02561195|EG010|Reported Event|100mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received placebo intramuscularly as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251465|NCT02561195|EG011|Reported Event|100mcg Clostridium Difficile Vaccine to 100mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 100 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 100 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251466|NCT02561195|EG012|Reported Event|200mcg Clostridium Difficile Vaccine to Placebo:Month 0, 1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received placebo as the fourth dose in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251467|NCT02561195|EG013|Reported Event|200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Month 0,1 and 6 Regimen|Eligible participants who received the first 3 doses of Clostridium difficile vaccine at the 200 mcg dose level received fourth dose of Clostridium difficile vaccine intramuscularly at the 200 mcg dose level in extension stage at visit 9 (340 to 380 Days after vaccination 3). Participants were followed up to 36 months after the last vaccination.
11251468|NCT02561221|BG000|Baseline|Lifestyle Counseling|"Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.~Trained health coaches delivered the active intervention - a comprehensive, high-intensity program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines."
11251469|NCT02561221|BG001|Baseline|Usual Care|"Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual health care schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc.~Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year."
11251470|NCT02561221|BG002|Baseline|Total|Total of all reporting groups
11251471|NCT02561221|FG000|Participant Flow|Lifestyle Counseling|"Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.~Trained health coaches delivered the active intervention - a comprehensive, high-intensity program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines."
11251472|NCT02561221|FG001|Participant Flow|Usual Care|Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
11251473|NCT02561221|OG000|Outcome|Lifestyle Counseling|"Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.~Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, high-intensity program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines."
11251474|NCT02561221|OG001|Outcome|Usual Care|Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
11251475|NCT02561221|EG000|Reported Event|Lifestyle Counseling|"Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.~Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, high-intensity program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines."
11251476|NCT02561221|EG001|Reported Event|Usual Care|Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
11251477|NCT02561247|BG000|Baseline|Prismaflex HF20 CRRT|Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
11251478|NCT02561247|FG000|Participant Flow|Prismaflex HF20 CRRT|Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
11251479|NCT02561247|OG000|Outcome|Prismaflex HF20 CRRT|Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
11251480|NCT02561247|EG000|Reported Event|Prismaflex HF20 CRRT|Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
11251481|NCT02561273|BG000|Baseline|10 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251482|NCT02561273|BG001|Baseline|15 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251483|NCT02561273|BG002|Baseline|Total|Total of all reporting groups
11251484|NCT02561273|FG000|Participant Flow|10 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251485|NCT02561273|FG001|Participant Flow|15 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251486|NCT02561273|OG000|Outcome|Treatment (Combination Chemotherapy, Lenalidomide)|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251487|NCT02561273|OG000|Outcome|10 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11251488|NCT02561273|OG001|Outcome|15 mg Lenalidomide Participants|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
11251489|NCT02561273|OG000|Outcome|Treatment (Combination Chemotherapy, Lenalidomide)|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lenalidomide: Given PO~Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood stem cell transplant~Prednisone: Given PO~Vincristine Sulfate: Given IV"
11286382|NCT02887404|EG000|Reported Event|Spine Surgery Analgesic Pathway|"Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Spine surgery analgesic pathway: Enhanced pain management care"
10969861|NCT00907803|BG001|Baseline|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
10969862|NCT00907803|BG002|Baseline|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
10969863|NCT00907803|BG003|Baseline|Total|Total of all reporting groups
10969864|NCT00907803|FG000|Participant Flow|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
11251490|NCT02561273|EG000|Reported Event|Treatment (10 mg Lenalidomide)|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251491|NCT02561273|EG001|Reported Event|Treatment (15 mg Lenalidomide)|"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant"
11251492|NCT02561338|BG000|Baseline|HMS5552 Dose 1|HMS5552: 75mgQD
11251493|NCT02561338|BG001|Baseline|HMS5552 Dose 2|HMS5552: 100mgQD
11251494|NCT02561338|BG002|Baseline|HMS5552 Dose 3|HMS5552: 50mgBID
11251495|NCT02561338|BG003|Baseline|HMS5552 Dose 4|HMS5552: 75mgBID
11251496|NCT02561338|BG004|Baseline|Placebo|Placebo: BID/QD
11251497|NCT02561338|BG005|Baseline|Total|Total of all reporting groups
11251498|NCT02561338|FG000|Participant Flow|HMS5552 Dose 1|HMS5552: 75mgQD
11251499|NCT02561338|FG001|Participant Flow|HMS5552 Dose 2|HMS5552: 100mgQD
11251500|NCT02561338|FG002|Participant Flow|HMS5552 Dose 3|HMS5552: 50mgBID
10969865|NCT00907803|FG001|Participant Flow|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
10969866|NCT00907803|FG002|Participant Flow|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
10969867|NCT00907803|OG000|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
10969868|NCT00907803|OG001|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
10969869|NCT00907803|OG002|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
10969870|NCT00907803|EG000|Reported Event|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
10969871|NCT00907803|EG001|Reported Event|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
10969872|NCT00907803|EG002|Reported Event|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
10969873|NCT00907881|BG000|Baseline|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
10969874|NCT00907881|FG000|Participant Flow|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
11251501|NCT02561338|FG003|Participant Flow|HMS5552 Dose 4|HMS5552: 75mgBID
11251502|NCT02561338|FG004|Participant Flow|Placebo|Placebo, BID/QD
11251503|NCT02561338|OG000|Outcome|HMS5552 Dose 1|HMS5552: 75mgQD
11251504|NCT02561338|OG001|Outcome|HMS5552 Dose 2|HMS5552:100mgQD
11251505|NCT02561338|OG002|Outcome|HMS5552 Dose 3|HMS5552: 50mgBID
11251506|NCT02561338|OG003|Outcome|HMS5552 Dose 4|HMS5552: 75mgBID
11251507|NCT02561338|OG004|Outcome|Placebo|Placebo:BID/QD
11251508|NCT02561338|OG001|Outcome|HMS5552 Dose 2|HMS5552: 100mgQD
11251509|NCT02561338|OG004|Outcome|Placebo|Placebo, BID/QD
11251510|NCT02561338|EG000|Reported Event|HMS5552 Dose 1|HMS5552: 75mgQD
11251511|NCT02561338|EG001|Reported Event|HMS5552 Dose 2|HMS5552: 100mgQD
11251512|NCT02561338|EG002|Reported Event|HMS5552 Dose 3|HMS5552: 50mgBID
11251513|NCT02561338|EG003|Reported Event|HMS5552 Dose 4|HMS5552: 75mgBID
11251514|NCT02561338|EG004|Reported Event|Placebo|Placebo: BID/QD
11251515|NCT02561455|BG000|Baseline|Gilteritinib 40 mg|Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251516|NCT02561455|BG001|Baseline|Gilteritinib 80 mg|Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251517|NCT02561455|BG002|Baseline|Gilteritinib 120 mg|Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251518|NCT02561455|BG003|Baseline|Gilteritinib 200 mg|Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251519|NCT02561455|BG004|Baseline|Total|Total of all reporting groups
11251520|NCT02561455|FG000|Participant Flow|Gilteritinib 40 mg|Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251521|NCT02561455|FG001|Participant Flow|Gilteritinib 80 mg|Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251522|NCT02561455|FG002|Participant Flow|Gilteritinib 120 mg|Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251523|NCT02561455|FG003|Participant Flow|Gilteritinib 200 mg|Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251524|NCT02561455|OG000|Outcome|Gilteritinib 40 mg|Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251525|NCT02561455|OG001|Outcome|Gilteritinib 80 mg|Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251526|NCT02561455|OG002|Outcome|Gilteritinib 120 mg|Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251527|NCT02561455|OG003|Outcome|Gilteritinib 200 mg|Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251528|NCT02561455|EG000|Reported Event|Gilteritinib 40 mg|Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251529|NCT02561455|EG001|Reported Event|Gilteritinib 80 mg|Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251530|NCT02561455|EG002|Reported Event|Gilteritinib 120 mg|Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251531|NCT02561455|EG003|Reported Event|Gilteritinib 200 mg|Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
11251532|NCT02561481|BG000|Baseline|Sulforaphane|"Sulforaphane (SF) will be administered once a day orally in an approximate dose of 1 µmol/lb (2.2 kg µmol/kg) body weight. Each SF tablet will contain 125 mg broccoli seed powder (equivalent to ~ 15 µmol SF). The total dose per day will depend on participants' body weight:~30-50 lb: 3 tablets (45 µmol/day) 50-70 lb: 4 tablets (60 µmol/day) 70-90 lb: 6 tablets (90 µmol/day) 90-110 lb: 7 tablets (105 µmol/day) 110-130 lb: 8 tablets (120 µmol/day)~For pilot study, all participants (n=10) will receive SF for 14 days. For main clinical trial, 25 participants will randomly receive SF for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo to sulforaphane arm will take place, and all participants will receive SF from 15-30 weeks.~Sulforaphane: See under active arm description"
11251533|NCT02561481|BG001|Baseline|Placebo|"Placebo tablets identical in size and similar in appearance to the active tablets will be used. Number of placebo tablets will be equivalent to the active tablets depending on participants' body weight.~For the main clinical trial, 25 participants will be randomly allocated to receive placebo for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo arm to sulforaphane arm will take place, and all participants will receive sulforaphane from 15-30 weeks.~Placebo: See under placebo arm description"
11251534|NCT02561481|BG002|Baseline|Total|Total of all reporting groups
11251535|NCT02561481|FG000|Participant Flow|Sulforaphane|"Sulforaphane (SF) will be administered once a day orally in an approximate dose of 1 µmol/lb (2.2 kg µmol/kg) body weight. Each SF tablet will contain 125 mg broccoli seed powder (equivalent to ~ 15 µmol SF). The total dose per day will depend on participants' body weight:~30-50 lb: 3 tablets (45 µmol/day) 50-70 lb: 4 tablets (60 µmol/day) 70-90 lb: 6 tablets (90 µmol/day) 90-110 lb: 7 tablets (105 µmol/day) 110-130 lb: 8 tablets (120 µmol/day)~For pilot study, all participants (n=10) will receive SF for 14 days. For main clinical trial, 25 participants will randomly receive SF for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo to sulforaphane arm will take place, and all participants will receive SF from 15-30 weeks.~Sulforaphane: See under active arm description"
11251536|NCT02561481|FG001|Participant Flow|Placebo|"Placebo tablets identical in size and similar in appearance to the active tablets will be used. Number of placebo tablets will be equivalent to the active tablets depending on participants' body weight.~For the main clinical trial, 25 participants will be randomly allocated to receive placebo for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo arm to sulforaphane arm will take place, and all participants will receive sulforaphane from 15-30 weeks.~Placebo: See under placebo arm description"
11251537|NCT02561481|OG000|Outcome|Sulforaphane|"Sulforaphane (SF) will be administered once a day orally in an approximate dose of 1 µmol/lb (2.2 kg µmol/kg) body weight. Each SF tablet will contain 125 mg broccoli seed powder (equivalent to ~ 15 µmol SF). The total dose per day will depend on participants' body weight:~30-50 lb: 3 tablets (45 µmol/day) 50-70 lb: 4 tablets (60 µmol/day) 70-90 lb: 6 tablets (90 µmol/day) 90-110 lb: 7 tablets (105 µmol/day) 110-130 lb: 8 tablets (120 µmol/day)~For pilot study, all participants (n=10) will receive SF for 14 days. For main clinical trial, 25 participants will randomly receive SF for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo to sulforaphane arm will take place, and all participants will receive SF from 15-30 weeks.~Sulforaphane: See under active arm description"
11251538|NCT02561481|OG001|Outcome|Placebo|"Placebo tablets identical in size and similar in appearance to the active tablets will be used. Number of placebo tablets will be equivalent to the active tablets depending on participants' body weight.~For the main clinical trial, 25 participants will be randomly allocated to receive placebo for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo arm to sulforaphane arm will take place, and all participants will receive sulforaphane from 15-30 weeks.~Placebo: See under placebo arm description"
11251539|NCT02561481|OG000|Outcome|Sulforaphane|Children receiving sulforaphane 0 - 30 weeks
11251540|NCT02561481|OG001|Outcome|Placebo|Children receiving placebo from 0 - 15 weeks; received sulforaphane (SF) from 16 - 30 weeks.
11251541|NCT02561481|OG001|Outcome|Placebo|Children receiving placebo 0 - 15 weeks; sulforaphane from 16 - 30 weeks
11251542|NCT02561481|EG000|Reported Event|Sulforaphane|"Sulforaphane (SF) will be administered once a day orally in an approximate dose of 1 µmol/lb (2.2 kg µmol/kg) body weight. Each SF tablet will contain 125 mg broccoli seed powder (equivalent to ~ 15 µmol SF). The total dose per day will depend on participants' body weight:~30-50 lb: 3 tablets (45 µmol/day) 50-70 lb: 4 tablets (60 µmol/day) 70-90 lb: 6 tablets (90 µmol/day) 90-110 lb: 7 tablets (105 µmol/day) 110-130 lb: 8 tablets (120 µmol/day)~For pilot study, all participants (n=10) will receive SF for 14 days. For main clinical trial, 25 participants will randomly receive SF for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo to sulforaphane arm will take place, and all participants will receive SF from 15-30 weeks.~Sulforaphane: See under active arm description"
11251543|NCT02561481|EG001|Reported Event|Placebo|"Placebo tablets identical in size and similar in appearance to the active tablets will be used. Number of placebo tablets will be equivalent to the active tablets depending on participants' body weight.~For the main clinical trial, 25 participants will be randomly allocated to receive placebo for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo arm to sulforaphane arm will take place, and all participants will receive sulforaphane from 15-30 weeks.~Placebo: See under placebo arm description"
11251544|NCT02561572|BG000|Baseline|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
11251545|NCT02561572|BG001|Baseline|Control|No intervention for 30 minutes.
11251546|NCT02561572|BG002|Baseline|Total|Total of all reporting groups
11251547|NCT02561572|FG000|Participant Flow|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
11251548|NCT02561572|FG001|Participant Flow|Control|No intervention for 30 minutes.
11251549|NCT02561572|OG000|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
11251550|NCT02561572|OG001|Outcome|Control|No intervention for 30 minutes.
11251551|NCT02561572|EG000|Reported Event|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
11251552|NCT02561572|EG001|Reported Event|Control|No intervention for 30 minutes.
11251553|NCT02561585|BG000|Baseline|LEO 124249|LEO 124249 ointment 30 mg/g twice daily
11251554|NCT02561585|BG001|Baseline|LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily
11251555|NCT02561585|BG002|Baseline|Total|Total of all reporting groups
11251556|NCT02561585|FG000|Participant Flow|LEO 124249|LEO 124249 ointment 30 mg/g twice daily
11251557|NCT02561585|FG001|Participant Flow|LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily
11251558|NCT02561585|OG000|Outcome|LEO 124249|LEO 124249 ointment 30 mg/g twice daily application
11251559|NCT02561585|OG001|Outcome|LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily application
11251560|NCT02561585|OG000|Outcome|Baseline: LEO 124249|LEO 124249 ointment 30 mg/g twice daily application
11251561|NCT02561585|OG001|Outcome|Baseline: LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily application
11251562|NCT02561585|OG002|Outcome|Week 12: LEO 124249|LEO 124249 ointment 30 mg/g twice daily application
11251563|NCT02561585|OG003|Outcome|Week 12: LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily application
11251564|NCT02561585|EG000|Reported Event|LEO 124249|LEO 124249 ointment 30 mg/g twice daily
11251565|NCT02561585|EG001|Reported Event|LEO 124249 Vehicle|LEO 124249 ointment vehicle twice daily
11251566|NCT02561702|BG000|Baseline|All Participants|
11251567|NCT02561702|FG000|Participant Flow|Mexiletine First/Placebo Second|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251568|NCT02561702|FG001|Participant Flow|Placebo First/Mexiletine Second|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251569|NCT02561702|OG000|Outcome|Mexiletine|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251570|NCT02561702|OG001|Outcome|Placebo|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251571|NCT02561702|EG000|Reported Event|Mexiletine|"Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251572|NCT02561702|EG001|Reported Event|Placebo|"Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily~Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days~Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days"
11251573|NCT02561806|BG000|Baseline|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
11251574|NCT02561806|BG001|Baseline|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
11251575|NCT02561806|BG002|Baseline|Total|Total of all reporting groups
11251576|NCT02561806|FG000|Participant Flow|Ustekinumab|45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
11251577|NCT02561806|FG001|Participant Flow|Ixekizumab|160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
11251578|NCT02561806|OG000|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
11251579|NCT02561806|OG001|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
11251580|NCT02561806|OG000|Outcome|Ustekinumab|"45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.~Ustekinumab: Administered SC"
11251581|NCT02561806|OG001|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.~Ixekizumab: Administered SC"
11251582|NCT02561806|OG000|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
11251583|NCT02561806|OG001|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
10969875|NCT00907881|OG000|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
11251584|NCT02561806|OG000|Outcome|Ustekinumab|"45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.~Ustekinumab: Administered SC"
11251585|NCT02561806|OG001|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.~Ixekizumab: Administered SC"
10969876|NCT00907881|EG000|Reported Event|All Participants|
11251586|NCT02561806|OG000|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was be used for blinding.
11251587|NCT02561806|OG000|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
11251588|NCT02561806|OG001|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
11251589|NCT02561806|OG001|Outcome|Ixekizumab|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injectio was used for blinding.
11251590|NCT02561806|OG000|Outcome|Ustekinumab|45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding
11251591|NCT02561806|EG000|Reported Event|Ustekinumab - Induction|45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.
11251592|NCT02561806|EG001|Reported Event|Ixekizumab - Induction|"160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks.~Placebo for Ustekinumab injection was used for blinding."
11251593|NCT02561806|EG002|Reported Event|Ustekinumab - Maintenance|45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.
11251594|NCT02561806|EG003|Reported Event|Ixekizumab - Maintenance|80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding.
11251595|NCT02561806|EG004|Reported Event|Ustekinumab - Post Treatment Follow up|Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
11251596|NCT02561806|EG005|Reported Event|Ixekizumab - Post Treatment Follow up|Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
11251597|NCT02561832|BG000|Baseline|Cohort 1|Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 week
11251598|NCT02561832|BG001|Baseline|Cohort 2|Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
11251599|NCT02561832|BG002|Baseline|Total|Total of all reporting groups
11251600|NCT02561832|FG000|Participant Flow|Cohort 1|Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 week
11251601|NCT02561832|FG001|Participant Flow|Cohort 2|Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
11251602|NCT02561832|OG000|Outcome|Cohort 1|Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 weeks
11251603|NCT02561832|OG001|Outcome|Cohort 2|Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
11251604|NCT02561832|EG000|Reported Event|Cohort 1|Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 weeks
11251605|NCT02561832|EG001|Reported Event|Cohort 2|Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
11251606|NCT02561897|BG000|Baseline|Edoxaban|"Edoxaban 30 or 60 mg~Edoxaban"
11251607|NCT02561897|BG001|Baseline|Warfarin|"Warfarin 1 -1 0 mg~Warfarin"
11251608|NCT02561897|BG002|Baseline|Total|Total of all reporting groups
11251609|NCT02561897|FG000|Participant Flow|Edoxaban|"Edoxaban 30 or 60 mg~Edoxaban"
11251610|NCT02561897|FG001|Participant Flow|Warfarin|"Warfarin 1 -1 0 mg~Warfarin"
11251611|NCT02561897|OG000|Outcome|Warfarin|One patient had a hematoma
11251612|NCT02561897|OG001|Outcome|Edoxaban|No patient met primary outcome
11251613|NCT02561897|OG000|Outcome|Warfarin|No patient had secondary outcome
11251614|NCT02561897|OG001|Outcome|Edoxaban|No patient had secondary outcome
11251615|NCT02561897|EG000|Reported Event|Warfarin|To maintain therapeutic INR level
11251616|NCT02561897|EG001|Reported Event|Edoxaban|60 mg tablet once daily
11251617|NCT02562066|BG000|Baseline|Amifampridine Phosphate - Placebo|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive amifampridine in Period I and then crossed over to receive placebo in Period II. Each randomized treatment period is 7 days in duration and is separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
11251618|NCT02562066|BG001|Baseline|Placebo - Amifampridine Phosphate|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive placebo in Period I and then crossed over to receive amifampridine in Period II. Each randomized treatment period is 7 days in duration and separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~amifampridine phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
11251619|NCT02562066|BG002|Baseline|Total|Total of all reporting groups
11251620|NCT02562066|FG000|Participant Flow|Amifampridine Phosphate - Placebo|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive amifampridine in Period I and then crossed over to receive placebo in Period II. Each randomized treatment period is 7 days in duration and is separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
11251621|NCT02562066|FG001|Participant Flow|Placebo - Amifampridine Phosphate|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive placebo in Period I and then crossed over to receive amifampridine in Period II. Each randomized treatment period is 7 days in duration and separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~amifampridine phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
11251622|NCT02562066|FG002|Participant Flow|Amifampridine Phosphate Only|Patients receiving amifampridine during the open-label run-in period but were not randomized for the crossover portion of the study.
11251623|NCT02562066|OG000|Outcome|Amifampridine Phosphate - Placebo|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive amifampridine in Period I and then crossed over to receive placebo in Period II. Each randomized treatment period is 7 days in duration and is separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
10969877|NCT00908011|BG000|Baseline|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
10969878|NCT00908011|BG001|Baseline|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
10969879|NCT00908011|BG002|Baseline|Total|Total of all reporting groups
10969880|NCT00908011|FG000|Participant Flow|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
11286383|NCT02887404|EG001|Reported Event|Usual Care|"Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).~Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).~After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.~Usual Care: Standard of pain management care"
10969881|NCT00908011|FG001|Participant Flow|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
10969882|NCT00908011|OG000|Outcome|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
10969883|NCT00908011|OG001|Outcome|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
10969884|NCT00908011|EG000|Reported Event|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
10969885|NCT00908011|EG001|Reported Event|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
10969886|NCT00908037|BG000|Baseline|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
11251624|NCT02562066|OG001|Outcome|Placebo - Amifampridine Phosphate|"Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects will be randomized to receive placebo in Period I and then crossed over to receive amifampridine in Period II. Each randomized treatment period is 7 days in duration and separated by a re-stabilization period of approximately two weeks where the subject will be returned to the stable dose administered at the end of the open-label run-in period. Dosing will be between 20 - 80 mg per day and frequency will be between 2-4 times per day.~amifampridine phosphate: Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.~Placebo: A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate."
11251625|NCT02562066|EG000|Reported Event|Amifampridine Phosphate|Treatment administered to the patient at the time of onset of the AE. Includes patients who received amifampridine phosphate during the run-in period who were not randomized for inclusion in the crossover portion of the study.
11251626|NCT02562066|EG001|Reported Event|Placebo|Treatment administered to the patient at the time of onset of the AE.
11286384|NCT02887521|BG000|Baseline|Pulmonary Rehabilitation (PR)|"Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery. Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process. Patients will also receive a log for recording their efforts and notes for every day until the day of surgery. A video recording of the intervention from start to finish will be provided to all patients. The video recording should be played in all 10 sessions at the registering site. The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~education: pulmonary rehabilitation participant manual~rehabilitation: pulmonary rehabilitation~surgery: patients undergo surgery"
11286385|NCT02887521|BG001|Baseline|Standard of Care|"Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery. The patients will not be asked to return the pedometer. The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient. The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~pedometer: receive a pedometer~education: receive a pamphlet with exercises plus the standard course of care~surgery: patients undergo surgery"
11286386|NCT02887521|BG002|Baseline|Total|Total of all reporting groups
11286387|NCT02887521|FG000|Participant Flow|Pulmonary Rehabilitation (PR)|"Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery. Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process. Patients will also receive a log for recording their efforts and notes for every day until the day of surgery. A video recording of the intervention from start to finish will be provided to all patients. The video recording should be played in all 10 sessions at the registering site. The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~education: pulmonary rehabilitation participant manual~rehabilitation: pulmonary rehabilitation~surgery: patients undergo surgery"
11286388|NCT02887521|FG001|Participant Flow|Standard of Care|"Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery. The patients will not be asked to return the pedometer. The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient. The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~pedometer: receive a pedometer~education: receive a pamphlet with exercises plus the standard course of care~surgery: patients undergo surgery"
11286389|NCT02887521|OG000|Outcome|Pulmonary Rehabilitation (PR)|"Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery. Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process. Patients will also receive a log for recording their efforts and notes for every day until the day of surgery. A video recording of the intervention from start to finish will be provided to all patients. The video recording should be played in all 10 sessions at the registering site. The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~education: pulmonary rehabilitation participant manual~rehabilitation: pulmonary rehabilitation~surgery: patients undergo surgery"
11286390|NCT02887521|OG001|Outcome|Standard of Care|"Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery. The patients will not be asked to return the pedometer. The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient. The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~pedometer: receive a pedometer~education: receive a pamphlet with exercises plus the standard course of care~surgery: patients undergo surgery"
11251627|NCT02562482|BG000|Baseline|Group 1: VRC-CHKVLP059-00-VP 20 mcg|"Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg).~VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997)."
11251628|NCT02562482|BG001|Baseline|Group 2: Placebo (VRC-PBSPLA043-00-VP)|"Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days).~VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine."
11251629|NCT02562482|BG002|Baseline|Total|Total of all reporting groups
11251630|NCT02562482|FG000|Participant Flow|Group 1: VRC-CHKVLP059-00-VP 20 mcg|"Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg).~VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997)."
11251631|NCT02562482|FG001|Participant Flow|Group 2: Placebo (VRC-PBSPLA043-00-VP)|"Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days).~VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine."
11251632|NCT02562482|OG000|Outcome|Group 1: VRC-CHKVLP059-00-VP 20 mcg|"Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg).~VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997)."
11251633|NCT02562482|OG001|Outcome|Group 2: Placebo (VRC-PBSPLA043-00-VP)|"Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days).~VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine."
11251634|NCT02562482|EG000|Reported Event|Group 1: VRC-CHKVLP059-00-VP 20 mcg|"Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg).~VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997)."
11251635|NCT02562482|EG001|Reported Event|Group 2: Placebo (VRC-PBSPLA043-00-VP)|"Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days).~VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine."
11251636|NCT02562521|BG000|Baseline|Test Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
11251637|NCT02562521|BG001|Baseline|Control Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
11251638|NCT02562521|BG002|Baseline|Total|Total of all reporting groups
11251639|NCT02562521|FG000|Participant Flow|Test Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
11251640|NCT02562521|FG001|Participant Flow|Control Site Participants|Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site.
11251641|NCT02562521|OG000|Outcome|Smoking Cessation Treatment|"The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.~Contingency management: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.~Nicotine replacement therapy: Participants have the option of using nicotine patch in combination with nicotine gum or lozenge~Varenicline: Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative~Additional behavioral support: Based on interest,"
11251642|NCT02562521|OG001|Outcome|Delayed Treatment Control|Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
11251643|NCT02562521|OG000|Outcome|All Participants Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
11251644|NCT02562521|EG000|Reported Event|All Participants Who Enrolled in Treatment|All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation and adverse event outcomes because all participants ultimately received the same treatment components.
11251645|NCT02562755|BG000|Baseline|Pexa-Vec Followed by Sorafenib|"Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.~Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251646|NCT02562755|BG001|Baseline|Sorafenib|"Sorafenib (400 mg twice daily) begins on Day 1.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251647|NCT02562755|BG002|Baseline|Total|Total of all reporting groups
11251648|NCT02562755|FG000|Participant Flow|Pexa-Vec Followed by Sorafenib|"Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.~Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251649|NCT02562755|FG001|Participant Flow|Sorafenib|"Sorafenib (400 mg twice daily) begins on Day 1.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251650|NCT02562755|OG000|Outcome|Pexa-Vec Followed by Sorafenib|"Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.~Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251651|NCT02562755|OG001|Outcome|Sorafenib|"Sorafenib (400 mg twice daily) begins on Day 1.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251652|NCT02562755|EG000|Reported Event|Pexa-Vec Followed by Sorafenib|"Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.~Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251653|NCT02562755|EG001|Reported Event|Sorafenib|"Sorafenib (400 mg twice daily) begins on Day 1.~Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
11251654|NCT02562898|BG000|Baseline|Dose Escalation for Safety and Toxicity|All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
11251655|NCT02562898|BG001|Baseline|Immune Response Cohort|Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
11251656|NCT02562898|BG002|Baseline|Total|Total of all reporting groups
11251657|NCT02562898|FG000|Participant Flow|Dose Escalation for Safety and Toxicity|All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
11251658|NCT02562898|FG001|Participant Flow|Immune Response Cohort|Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
11251659|NCT02562898|OG000|Outcome|Dose Escalation for Safety and Toxicity|"All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.~Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle~Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle~Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle"
11251660|NCT02562898|OG001|Outcome|Immune Response Cohort|"Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.~Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle~Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle~Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle"
11251661|NCT02562898|EG000|Reported Event|Dose Escalation for Safety and Toxicity|All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
11251662|NCT02562898|EG001|Reported Event|Immune Response Cohort|Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
11251663|NCT02562924|BG000|Baseline|Budesonide Rinse Group|"1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.~Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake"
11251664|NCT02562924|BG001|Baseline|MEDIHONEY® Rinse Alone Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i until day 182~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182~MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties"
11251665|NCT02562924|BG002|Baseline|MEDIHONEY® and Budesonide Rinse Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182.~ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182."
11251666|NCT02562924|BG003|Baseline|Total|Total of all reporting groups
11251667|NCT02562924|FG000|Participant Flow|Budesonide Rinse Group|"1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.~Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake"
11251668|NCT02562924|FG001|Participant Flow|MEDIHONEY® Rinse Alone Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i until day 182~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182~MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties"
11251669|NCT02562924|FG002|Participant Flow|MEDIHONEY® and Budesonide Rinse Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182.~ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182."
11251670|NCT02562924|OG000|Outcome|Budesonide Rinse Group|"1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.~Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake"
11251671|NCT02562924|OG001|Outcome|MEDIHONEY® Rinse Alone Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i until day 182~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182~MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties"
11251672|NCT02562924|OG002|Outcome|MEDIHONEY® and Budesonide Rinse Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182.~ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182."
11251673|NCT02562924|OG000|Outcome|Budesonide Rinse Group|"1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray q 1 hour while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID (twice daily) c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182."
11251674|NCT02562924|OG001|Outcome|MEDIHONEY® Rinse Alone Group|"Days 0-7: Same as 1a;~Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of the MEDIHONEY®rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of the MEDIHONEY®rinse once daily. Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182."
11251675|NCT02562924|OG002|Outcome|MEDIHONEY® and Budesonide Rinse Group|"Days 0-7: Same as 1a.;~Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182.~ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182."
11251676|NCT02562924|EG000|Reported Event|Budesonide Rinse Group|"1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.~Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake"
11251677|NCT02562924|EG001|Reported Event|MEDIHONEY® Rinse Alone Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of MEDIHONEY® rinse once daily.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i until day 182~In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182~MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties"
11251678|NCT02562924|EG002|Reported Event|MEDIHONEY® and Budesonide Rinse Group|"Days 0-7: Same as 1a~Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID~After day 91:~i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182.~ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day.~Reevaluate at day 119:~In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.~In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182."
11251679|NCT02562989|BG000|Baseline|Part 1, Healthy Young Participants|Healthy young participants received a single intravenous (IV) dose of ~185 megabecquerel (MBq) [18F]MK-6240 in Part 1 of the study.
11251680|NCT02562989|BG001|Baseline|Part 2, Healthy Elderly Participants|Healthy elderly participants received a single IV dose of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251681|NCT02562989|BG002|Baseline|Part 2, AD and Amnestic MCI Elderly Participants|AD and amnestic MCI participants received up to two IV doses of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251682|NCT02562989|BG003|Baseline|Total|Total of all reporting groups
11251683|NCT02562989|FG000|Participant Flow|Part 1, Healthy Young Participants|Healthy young participants received a single intravenous (IV) dose of ~185 megabecquerel (MBq) [18F]MK-6240 in Part 1 of the study.
11251684|NCT02562989|FG001|Participant Flow|Part 2, Healthy Elderly Participants|Healthy elderly participants received a single IV dose of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251685|NCT02562989|FG002|Participant Flow|Part 2, AD and Amnestic MCI Elderly Participants|AD and amnestic MCI participants received up to two IV doses of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251686|NCT02562989|OG000|Outcome|Part 1, Healthy Young Participants|Healthy young participants received a single intravenous (IV) dose of ~185 megabecquerel (MBq) [18F]MK-6240 in Part 1 of the study.
11251687|NCT02562989|OG001|Outcome|Part 2, Healthy Elderly Participants|Healthy elderly participants received a single IV dose of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251688|NCT02562989|OG002|Outcome|Part 2, AD and Amnestic MCI Elderly Participants|AD and amnestic MCI participants received up to two IV doses of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251689|NCT02562989|EG000|Reported Event|Part 1, Healthy Young Participants|Healthy young participants received a single intravenous (IV) dose of ~185 megabecquerel (MBq) [18F]MK-6240 in Part 1 of the study.
11251690|NCT02562989|EG001|Reported Event|Part 2, Healthy Elderly Participants|Healthy elderly participants received a single IV dose of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251691|NCT02562989|EG002|Reported Event|Part 2, AD and Amnestic MCI Elderly Participants|AD and amnestic MCI participants received up to two IV doses of ~160 MBq [18F]MK-6240, in Part 2 of the study.
11251692|NCT02563067|BG000|Baseline|QAW039 150 mg|QAW039 150 mg once daily
11251693|NCT02563067|BG001|Baseline|QAW039 450 mg|QAW039 450 mg once daily
11251694|NCT02563067|BG002|Baseline|Placebo|Placebo once daily
11251695|NCT02563067|BG003|Baseline|Total|Total of all reporting groups
11251696|NCT02563067|FG000|Participant Flow|QAW039 150 mg|QAW039 150 mg once daily
11251697|NCT02563067|FG001|Participant Flow|QAW039 450 mg|QAW039 450 mg once daily
11251698|NCT02563067|FG002|Participant Flow|Placebo|Placebo once daily
11251699|NCT02563067|OG000|Outcome|QAW039 150 mg|QAW039 150 mg once daily
11251700|NCT02563067|OG001|Outcome|QAW039 450 mg|QAW039 450 mg once daily
11251701|NCT02563067|OG002|Outcome|Placebo|Placebo once daily
11251702|NCT02563067|EG000|Reported Event|QAW039 150 mg|QAW039 150 mg
11251703|NCT02563067|EG001|Reported Event|QAW039 450 mg|QAW039 450 mg
11251704|NCT02563067|EG002|Reported Event|Placebo|Placebo
11251705|NCT02563093|BG000|Baseline|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251706|NCT02563093|BG001|Baseline|Fluzone Quadrivalent Intradermal Vaccine|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
11251707|NCT02563093|BG002|Baseline|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251708|NCT02563093|BG003|Baseline|Fluzone High-Dose Vaccine|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
11251709|NCT02563093|BG004|Baseline|Total|Total of all reporting groups
11251710|NCT02563093|FG000|Participant Flow|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251711|NCT02563093|FG001|Participant Flow|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
11251712|NCT02563093|FG002|Participant Flow|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251713|NCT02563093|FG003|Participant Flow|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
11251714|NCT02563093|OG000|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251715|NCT02563093|OG001|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
11251716|NCT02563093|OG002|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251717|NCT02563093|OG003|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
11251718|NCT02563093|OG001|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
11251719|NCT02563093|EG000|Reported Event|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251720|NCT02563093|EG001|Reported Event|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
11251721|NCT02563093|EG002|Reported Event|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
11251722|NCT02563093|EG003|Reported Event|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
11251723|NCT02563106|BG000|Baseline|SYN-004|SYN-004 150 mg
11251724|NCT02563106|BG001|Baseline|Placebo|Matching Placebo
11251725|NCT02563106|BG002|Baseline|Total|Total of all reporting groups
11251726|NCT02563106|FG000|Participant Flow|SYN-004|SYN-004 150 mg
11251727|NCT02563106|FG001|Participant Flow|Placebo|Placebo (no active drug)
11251728|NCT02563106|OG000|Outcome|SYN-004|SYN-004 150 mg
11251729|NCT02563106|OG001|Outcome|Placebo|Matching placebo
11251730|NCT02563106|EG000|Reported Event|SYN-004|SYN-004 150 mg
11251731|NCT02563106|EG001|Reported Event|Placebo|Matching Placebo
11251732|NCT02563496|BG000|Baseline|Tafenoquine 50 mg|Participants with weight band of >=5 to <=10 kilogram (kg) were planned to receive 50 milligram (mg) tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251733|NCT02563496|BG001|Baseline|Tafenoquine 100 mg|Participants with weight band of >10 to <=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251734|NCT02563496|BG002|Baseline|Tafenoquine 150 mg|Participants with weight band of >10 to <=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251735|NCT02563496|BG003|Baseline|Tafenoquine 200 mg|Participants with weight band of >20 to <=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251736|NCT02563496|BG004|Baseline|Tafenoquine 300 mg|Participants with weight band of >35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251737|NCT02563496|BG005|Baseline|Total|Total of all reporting groups
11251738|NCT02563496|FG000|Participant Flow|Tafenoquine 50 mg|Participants with weight band of >=5 to <=10 kilogram (kg) were planned to receive 50 milligram (mg) tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251739|NCT02563496|FG001|Participant Flow|Tafenoquine 100 mg|Participants with weight band of >10 to <=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251740|NCT02563496|FG002|Participant Flow|Tafenoquine 150 mg|Participants with weight band of >10 to <=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251741|NCT02563496|FG003|Participant Flow|Tafenoquine 200 mg|Participants with weight band of >20 to <=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251742|NCT02563496|FG004|Participant Flow|Tafenoquine 300 mg|Participants with weight band of >35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251743|NCT02563496|OG000|Outcome|Tafenoquine 100 mg|Participants with weight band of >10 to <=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251744|NCT02563496|OG001|Outcome|Tafenoquine 150 mg|Participants with weight band of >10 to <=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251745|NCT02563496|OG002|Outcome|Tafenoquine 200 mg|Participants with weight band of >20 to <=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251746|NCT02563496|OG003|Outcome|Tafenoquine 300 mg|Participants with weight band of >35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251747|NCT02563496|OG000|Outcome|Tafenoquine 50 mg|Participants with weight band of >=5 to <=10 kilogram (kg) were planned to receive 50 milligram (mg) tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251748|NCT02563496|EG000|Reported Event|Tafenoquine 50 mg|Participants with weight band of >=5 to <=10 kg were planned to receive 50 mg tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251749|NCT02563496|EG001|Reported Event|Tafenoquine 100 mg|Participants with weight band of >10 to <=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251750|NCT02563496|EG002|Reported Event|Tafenoquine 150 mg|Participants with weight band of >10 to <=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251751|NCT02563496|EG003|Reported Event|Tafenoquine 200 mg|Participants with weight band of >20 to <=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251752|NCT02563496|EG004|Reported Event|Tafenoquine 300 mg|Participants with weight band of >35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
11251753|NCT02563548|BG000|Baseline|GAC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|"Dose escalation part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration.~Dose expansion part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration.~Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks)."
11251754|NCT02563548|BG001|Baseline|NSCLC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|"Dose escalation part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration.~Dose expansion part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration.~Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks)."
11251755|NCT02563548|BG002|Baseline|Total|Total of all reporting groups
11251756|NCT02563548|FG000|Participant Flow|Dose Escalation (GAC): PEGPH20 1.6 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGylated recombinant human hyaluronidase (PEGPH20) 1.6 micrograms/kilogram (µg/kg) on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 milligrams/kilogram (mg/kg) every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251757|NCT02563548|FG001|Participant Flow|Dose Escalation (NSCLC): PEGPH20 1.6 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 27 weeks).
11251758|NCT02563548|FG002|Participant Flow|Dose Escalation (GAC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251759|NCT02563548|FG003|Participant Flow|Dose Escalation (NSCLC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 27 weeks).
11251760|NCT02563548|FG004|Participant Flow|Dose Expansion (GAC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks).
11251761|NCT02563548|FG005|Participant Flow|Dose Expansion (NSCLC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251762|NCT02563548|OG000|Outcome|Dose Escalation (GAC): PEGPH20 1.6 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 1.6 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251763|NCT02563548|OG001|Outcome|Dose Escalation (GAC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251764|NCT02563548|OG002|Outcome|Dose Escalation (NSCLC): PEGPH20 1.6 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 27 weeks).
11251765|NCT02563548|OG003|Outcome|Dose Escalation (NSCLC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 27 weeks).
11251766|NCT02563548|OG000|Outcome|Dose Escalation Phase: All Participants (GAC and NSCLC)|Participants with relapsed/refractory locally advanced or metastatic GAC or Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC).
11251767|NCT02563548|OG000|Outcome|Dose Expansion (GAC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks).
11251768|NCT02563548|OG001|Outcome|Dose Expansion (NSCLC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251769|NCT02563548|OG000|Outcome|Dose Escalation (GAC): PEGPH20 1.6 or 2.2 µg/kg+Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251770|NCT02563548|OG001|Outcome|Dose Escalation(NSCLC): PEGPH20 1.6 or 2.2 µg/kg+Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 27 weeks).
11251771|NCT02563548|OG002|Outcome|Dose Expansion (GAC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks).
11251772|NCT02563548|OG003|Outcome|Dose Expansion (NSCLC): PEGPH20 2.2 µg/kg + Pembrolizumab|Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251773|NCT02563548|OG000|Outcome|PEGPH20 1.6 μg/kg + Pembrolizumab 2 mg/kg|Participants with relapsed/refractory locally advanced or metastatic GAC or relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration in dose escalation phase of study. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks in participants with GAC and 27 weeks in participants with NSCLC).
11251774|NCT02563548|OG001|Outcome|PEGPH20 2.2 μg/kg + Pembrolizumab 2 mg/kg|Participants with relapsed/refractory locally advanced or metastatic GAC or relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration in dose escalation phase of study. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks in participants with GAC and 27 weeks in participants with NSCLC).
11251775|NCT02563548|OG002|Outcome|PEGPH20 2.2 μg/kg + Pembrolizumab 200 mg|Participants with relapsed/refractory locally advanced or metastatic GAC or relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks in participants with GAC and 46 weeks in participants with NSCLC).
11251776|NCT02563548|OG000|Outcome|GAC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|Dose escalation part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Dose expansion part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks).
11251777|NCT02563548|OG001|Outcome|NSCLC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|Dose escalation part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Dose expansion part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251778|NCT02563548|EG000|Reported Event|GAC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|Dose escalation part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Dose expansion part: Participants with relapsed/refractory locally advanced or metastatic GAC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks).
11251779|NCT02563548|EG001|Reported Event|NSCLC: PEGPH20 1.6 µg/kg/2.2 µg/kg + Pembrolizumab|Dose escalation part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 1.6 µg/kg or 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle (i.e. 3 doses/cycle) and pembrolizumab 2 mg/kg every 21 days on Day 1 of each cycle (i.e. 1 dose/cycle), 4-6 hours after the completion of PEGPH20 administration. Dose expansion part: Participants with relapsed/refractory Stage IIIB or IV NSCLC received PEGPH20 2.2 µg/kg on Day 1, Day 8 and Day 15 of each 21-day cycle and pembrolizumab 200 mg on Day 1 of each cycle, 4-6 hours after the completion of PEGPH20 administration. Treatment in both phases of the study was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks).
11251780|NCT02563561|BG000|Baseline|1 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251781|NCT02563561|BG001|Baseline|2 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251782|NCT02563561|BG002|Baseline|Placebo|Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251783|NCT02563561|BG003|Baseline|Total|Total of all reporting groups
11251784|NCT02563561|FG000|Participant Flow|1 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251785|NCT02563561|FG001|Participant Flow|2 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251786|NCT02563561|FG002|Participant Flow|Placebo|Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251787|NCT02563561|OG000|Outcome|1 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251788|NCT02563561|OG001|Outcome|2 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251789|NCT02563561|OG002|Outcome|Placebo|Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251790|NCT02563561|EG000|Reported Event|1 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251791|NCT02563561|EG001|Reported Event|2 Dose Apaziquone|Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251792|NCT02563561|EG002|Reported Event|Placebo|Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
11251793|NCT02563808|BG000|Baseline|Survey: Standard Version|"Females will receive standard decisions aid for early stage breast cancer.~Survey: Standard"
11251794|NCT02563808|BG001|Baseline|Survey: Anticipated Regret Version|"Females will receive anticipated regret-augmented version for early breast cancer.~Survey: Regret"
11251795|NCT02563808|BG002|Baseline|Total|Total of all reporting groups
11251796|NCT02563808|FG000|Participant Flow|Survey: Standard Version|"Females will receive standard decisions aid for early stage breast cancer.~Survey: Standard"
11251797|NCT02563808|FG001|Participant Flow|Survey: Anticipated Regret Version|"Females will receive anticipated regret-augmented version for early breast cancer.~Survey: Regret"
11251798|NCT02563808|OG000|Outcome|Survey: Standard Version|"Females will receive standard decisions aid for early stage breast cancer.~Survey: Standard"
11251799|NCT02563808|OG001|Outcome|Survey: Anticipated Regret Version|"Females will receive anticipated regret-augmented version for early breast cancer.~Survey: Regret"
11251800|NCT02563808|EG000|Reported Event|Survey: Standard Version|"Females will receive standard decisions aid for early stage breast cancer.~Survey: Standard"
11251801|NCT02563808|EG001|Reported Event|Survey: Anticipated Regret Version|"Females will receive anticipated regret-augmented version for early breast cancer.~Survey: Regret"
11251802|NCT02563834|BG000|Baseline|Lean Controls|Lean non-diabetic control participants, taking no regular medications.
11251803|NCT02563834|BG001|Baseline|Type 2 Diabetes|Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
11251804|NCT02563834|BG002|Baseline|Total|Total of all reporting groups
11251805|NCT02563834|FG000|Participant Flow|Lean Control|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
11251806|NCT02563834|FG001|Participant Flow|Type 2 DM|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
11251807|NCT02563834|OG000|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
11251808|NCT02563834|OG001|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
11251809|NCT02563834|OG002|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
11251810|NCT02563834|OG003|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
11251811|NCT02563834|EG000|Reported Event|Saline|"Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
11251812|NCT02563834|EG001|Reported Event|Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
11251813|NCT02563860|BG000|Baseline|Open Label|"Female patients with genetically confirmed RTT, treatment arm only.~Treatment with Lovastatin, dose escalating trial according to the following schedule:~10 mg daily for 8 week 20 mg daily for 8 weeks 40 mg daily for 16 weeks.~Lovastatin: dose escallating"
11251814|NCT02563860|FG000|Participant Flow|Open Label|"Treatment with Lovastatin, dose escalating trial according to the following schedule:~All participants were assigned to the specified sequence of interventions and all participants received all the three dosing regimen please make this explicit in the Arm/Group Description. In either case, separate Period 1-10 mg daily for 8 week Period 2-20 mg daily for 8 weeks Period 3-40 mg daily for 16 weeks.~Lovastatin: dose escallating"
11251815|NCT02563860|OG000|Outcome|Open Label|"Treatment with Lovastatin, dose escalating trial according to the following schedule:~10 mg daily for 8 week 20 mg daily for 8 weeks 40 mg daily for 16 weeks.~Lovastatin: dose escallating"
11251816|NCT02563860|EG000|Reported Event|Open Label|"Treatment with Lovastatin, dose escalating trial according to the following schedule:~10 mg daily for 8 week 20 mg daily for 8 weeks 40 mg daily for 16 weeks.~Lovastatin: dose escallating"
11251817|NCT02563899|BG000|Baseline|202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
11251818|NCT02563899|BG001|Baseline|202093: Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
11251819|NCT02563899|BG002|Baseline|AC4112008: GSK573719|Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
11251820|NCT02563899|BG003|Baseline|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
11251821|NCT02563899|BG004|Baseline|Total|Total of all reporting groups
11251822|NCT02563899|FG000|Participant Flow|202093: Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 milligram per square centimeter (mg/cm^2) of the 1.85%, administered once daily (OD) to both axillae, at night before going to bed for 14 days.
11251823|NCT02563899|FG001|Participant Flow|202093: Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
11251824|NCT02563899|FG002|Participant Flow|AC4112008: GSK573719|Each participant received single dose of treatment in the following order of intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
11251825|NCT02563899|FG003|Participant Flow|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% weight/ weight (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 centimeter squared (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
11251826|NCT02563899|OG000|Outcome|Umeclidinium, 2 mg/cm^2 of 1.85%, OD|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
11251827|NCT02563899|OG000|Outcome|Pooled Umeclidinium Population PK Arm|This arm is consisted of pooled PK populations from study 202093, AC4112008 and LHH117157. In the study 202093 participants topically applied Umeclidinium 2 mg/cm^2 of 1.85%, administered OD to both axillae, at night before going to bed for 14 days. In the study AC411200 each participant received single dose of treatment in the following of order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. Washout was of 5 days between two consecutive periods. In the study LHH117157 a single dose of topically applied [14C] umeclidinium was administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% w/w solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 cm^2 surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg)
11251828|NCT02563899|OG001|Outcome|Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
11251829|NCT02563899|OG002|Outcome|AC4112008: GSK573719|Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
11251830|NCT02563899|OG003|Outcome|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution Umeclidinium (equivalent to a 2.2% Umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active Umeclidinium of 3.06 mg).
11251831|NCT02563899|EG000|Reported Event|202093:Umeclidinium|Participants topically applied Umeclidinium 2 mg/cm^2 of the 1.85% formulation, administered OD to both axillae, at night before going to bed for 14 days.
11251832|NCT02563899|EG001|Reported Event|202093:Vehicle|Participants topically applied vehicle, OD to both axillae, at night before going to bed for 14 days.
11251833|NCT02563899|EG002|Reported Event|AC4112008: GSK573719|Each participants received single dose of treatment in the following order intravenous GSK573719 20 µg followed by oral GSK573719 1000 μg followed by intravenous GSK573719 50 µg, followed by inhaled GSK573719 1000 μg followed by intravenous GSK573719 65 µg in period 1, 2, 3, 4 and 5 respectively. The washout was of 5 days between two consecutive periods.
11251834|NCT02563899|EG003|Reported Event|LHH117157: Cohort B|A single dose of topically applied [14C] umeclidinium administered to the occluded axilla. The dose to be administered was 165 mg of a 1.85% (w/w) solution umeclidinium (equivalent to a 2.2% umeclidinium bromide solution) applied to 40 (cm^2) surface area of occluded axilla (resulting in a calculated net amount of active umeclidinium of 3.06 mg).
11251835|NCT02563990|BG000|Baseline|High Pressure|"High pressure injection of Ropivacaine local anesthetic at greater than 20 psi~High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure~High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure"
11251836|NCT02563990|BG001|Baseline|Low Pressure|"Low pressure injection of Ropivacaine local anesthetic at less than 15 psi~Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure~Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure"
11251837|NCT02563990|BG002|Baseline|Total|Total of all reporting groups
11251838|NCT02563990|FG000|Participant Flow|High Pressure|"High pressure injection of Ropivacaine local anesthetic at greater than 20 psi~High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure~High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure"
11251839|NCT02563990|FG001|Participant Flow|Low Pressure|"Low pressure injection of Ropivacaine local anesthetic at less than 15 psi~Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure~Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure"
11251840|NCT02563990|OG000|Outcome|High Pressure|"High pressure injection of Ropivacaine local anesthetic at greater than 20 psi~High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure~High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure"
11251841|NCT02563990|OG001|Outcome|Low Pressure|"Low pressure injection of Ropivacaine local anesthetic at less than 15 psi~Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure~Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure"
11251842|NCT02563990|OG000|Outcome|High Pressure|"High pressure injection of Ropivacaine local anesthetic at greater than 20 psi~High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure"
11251843|NCT02563990|OG001|Outcome|Low Pressure|"Low pressure injection of Ropivacaine local anesthetic at less than 15 psi~Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure"
11251844|NCT02563990|EG000|Reported Event|High Pressure|"High pressure injection of Ropivacaine local anesthetic at greater than 20 psi~High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure~High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure"
11251845|NCT02563990|EG001|Reported Event|Low Pressure|"Low pressure injection of Ropivacaine local anesthetic at less than 15 psi~Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure~Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure"
11251846|NCT02564016|BG000|Baseline|Capped Epidural|"Group 1 (control) will have the epidural catheter capped and left in place.~Capped Epidural: epidural will be capped with no saline infusion."
11251847|NCT02564016|BG001|Baseline|Normal Saline Infusion|"Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour~Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour"
11251848|NCT02564016|BG002|Baseline|Total|Total of all reporting groups
11251849|NCT02564016|FG000|Participant Flow|Capped Epidural|"Group 1 (control) will have the epidural catheter capped and left in place.~Capped Epidural: epidural will be capped with no saline infusion."
11251850|NCT02564016|FG001|Participant Flow|Normal Saline Infusion|"Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour~Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour"
11251851|NCT02564016|OG000|Outcome|Capped Epidural|"Group 1 (control) will have the epidural catheter capped and left in place.~Capped Epidural: epidural will be capped with no saline infusion."
11251852|NCT02564016|OG001|Outcome|Normal Saline Infusion|"Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour~Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour"
11251853|NCT02564016|EG000|Reported Event|Capped Epidural|"Group 1 (control) will have the epidural catheter capped and left in place.~Capped Epidural: epidural will be capped with no saline infusion."
11251854|NCT02564016|EG001|Reported Event|Normal Saline Infusion|"Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour~Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour"
11251855|NCT02564029|BG000|Baseline|All Participants|A total of 7 participants were enrolled and assigned to study treatment.
11251856|NCT02564029|FG000|Participant Flow|All Study Participants|Subjects were randomly allocated to one of 4 different treatment sequences that each included the 4 treatment groups: Placebo, PF-06372865 17.5 mg, PF-06372865 52.5 mg and Lorazepam 2 mg.
11251857|NCT02564029|OG000|Outcome|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
11251858|NCT02564029|OG001|Outcome|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
11251859|NCT02564029|OG002|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
11251860|NCT02564029|OG003|Outcome|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
11251861|NCT02564029|OG000|Outcome|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
11251862|NCT02564029|EG000|Reported Event|Placebo|One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
11251863|NCT02564029|EG001|Reported Event|PF-06372865 17.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
11251864|NCT02564029|EG002|Reported Event|PF-06372865 52.5 mg|One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
11251865|NCT02564029|EG003|Reported Event|Lorazepam 2 mg|One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
11251866|NCT02564042|BG000|Baseline|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251867|NCT02564042|BG001|Baseline|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251868|NCT02564042|BG002|Baseline|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251869|NCT02564042|BG003|Baseline|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251870|NCT02564042|BG004|Baseline|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251871|NCT02564042|BG005|Baseline|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251872|NCT02564042|BG006|Baseline|Total|Total of all reporting groups
11251873|NCT02564042|FG000|Participant Flow|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251874|NCT02564042|FG001|Participant Flow|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251875|NCT02564042|FG002|Participant Flow|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251876|NCT02564042|FG003|Participant Flow|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251877|NCT02564042|FG004|Participant Flow|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251878|NCT02564042|FG005|Participant Flow|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251879|NCT02564042|OG000|Outcome|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251880|NCT02564042|OG001|Outcome|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251881|NCT02564042|OG002|Outcome|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251882|NCT02564042|OG003|Outcome|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251883|NCT02564042|OG004|Outcome|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251884|NCT02564042|OG005|Outcome|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251885|NCT02564042|EG000|Reported Event|GSK2894512 1% BID|The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251886|NCT02564042|EG001|Reported Event|GSK2894512 1% QD|The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251887|NCT02564042|EG002|Reported Event|GSK2894512 0.5% BID|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251888|NCT02564042|EG003|Reported Event|GSK2894512 0.5% QD|The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251889|NCT02564042|EG004|Reported Event|Vehicle BID|The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251890|NCT02564042|EG005|Reported Event|Vehicle QD|The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
11251891|NCT02564055|BG000|Baseline|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251892|NCT02564055|BG001|Baseline|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251893|NCT02564055|BG002|Baseline|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251894|NCT02564055|BG003|Baseline|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251895|NCT02564055|BG004|Baseline|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
11251896|NCT02564055|BG005|Baseline|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
11251897|NCT02564055|BG006|Baseline|Total|Total of all reporting groups
11251898|NCT02564055|FG000|Participant Flow|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251899|NCT02564055|FG001|Participant Flow|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251900|NCT02564055|FG002|Participant Flow|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251901|NCT02564055|FG003|Participant Flow|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251902|NCT02564055|FG004|Participant Flow|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks.
11251903|NCT02564055|FG005|Participant Flow|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks.
11251904|NCT02564055|OG000|Outcome|GSK2894512 1% BID|Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251905|NCT02564055|OG001|Outcome|GSK2894512 1% QD|Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251906|NCT02564055|OG002|Outcome|GSK2894512 0.5% BID|Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
11251907|NCT02564055|OG003|Outcome|GSK2894512 0.5% QD|Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.
11251908|NCT02564055|OG004|Outcome|Vehicle BID|Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks
11251909|NCT02564055|OG005|Outcome|Vehicle QD|Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks
11251910|NCT02564055|EG000|Reported Event|GSK2894512 1% Cream Twice Daily|Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram [mg/g]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251911|NCT02564055|EG001|Reported Event|GSK2894512 1% Cream Once Daily|Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251912|NCT02564055|EG002|Reported Event|GSK2894512 0.5% Cream Twice Daily|Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251913|NCT02564055|EG003|Reported Event|GSK2894512 0.5% Cream Once Daily|Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251914|NCT02564055|EG004|Reported Event|Vehicle Cream Twice Daily|Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251915|NCT02564055|EG005|Reported Event|Vehicle Cream Once Daily|Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
11251916|NCT02564120|BG000|Baseline|Active Surveillance|Men placed on active surveillance (i.e., did not receive immediate treatment)
11251917|NCT02564120|BG001|Baseline|SBRT|Men who received stereotactic body radiation therapy
11251918|NCT02564120|BG002|Baseline|Radical Prostatectomy|Men treated with radical prostatectomy (i.e., surgery)
11251919|NCT02564120|BG003|Baseline|EBRT|Men treated with external beam radiation therapy
11251920|NCT02564120|BG004|Baseline|Brachytherapy|Men treated with brachytherapy
11251921|NCT02564120|BG005|Baseline|Total|Total of all reporting groups
11251922|NCT02564120|FG000|Participant Flow|NC ProCESS Cohort|NC ProCESS is a cohort of patients with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they started treatment, and were then followed prospectively.
11251923|NCT02564120|OG000|Outcome|Active Surveillance|Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
11251924|NCT02564120|OG001|Outcome|Stereotactic Body Radiation Therapy|Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
11251925|NCT02564120|OG002|Outcome|Radical Prostatectomy|Patients who received initial treatment with radical prostatectomy.
11251926|NCT02564120|OG003|Outcome|External Body Radiation Therapy|Patients who received initial treatment with external body radiation therapy (EBRT).
11251927|NCT02564120|OG004|Outcome|Brachytherapy|Patients who received initial treatment with brachytherapy.
11251928|NCT02564120|OG000|Outcome|Stereotactic Body Radiation Therapy|Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
11251929|NCT02564120|OG001|Outcome|Radical Prostatectomy|Patients who received initial treatment with radical prostatectomy.
11251930|NCT02564120|OG002|Outcome|External Body Radiation Therapy|Patients who received initial treatment with external body radiation therapy (EBRT).
11251931|NCT02564120|OG003|Outcome|Brachytherapy|Patients who received initial treatment with brachytherapy.
11251932|NCT02564120|OG001|Outcome|Any Active Treatment|Patients who received initial treatment with surgery or radiation, including brachytherapy or SBRT.
11251933|NCT02564120|OG003|Outcome|SBRT/EBRT|Patients who received initial treatment with stereotactic body radiation therapy (SBRT) or external body radiation therapy (EBRT).
11251934|NCT02564120|EG000|Reported Event|NC ProCESS Cohort|NC ProCESS cohort is a population-based, prospective prostate cancer patient cohort.
11251935|NCT02564198|BG000|Baseline|8 mg/kg Ramucirumab (Part A)|Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
11251936|NCT02564198|BG001|Baseline|12 mg/kg Ramucirumab (Part A)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251937|NCT02564198|BG002|Baseline|12 mg/kg Ramucirumab (Part B)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251938|NCT02564198|BG003|Baseline|Total|Total of all reporting groups
11251939|NCT02564198|FG000|Participant Flow|8 mg/kg Ramucirumab (Part A)|Participants received 8 milligram per kilogram [mg/kg] Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.
11251940|NCT02564198|FG001|Participant Flow|12 mg/kg Ramucirumab (Part A)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251941|NCT02564198|FG002|Participant Flow|12 mg/kg Ramucirumab (Part B)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251942|NCT02564198|OG000|Outcome|8 mg/kg Ramucirumab (Part A)|Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
11251943|NCT02564198|OG001|Outcome|12 mg/kg Ramucirumab (Part A)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251944|NCT02564198|OG000|Outcome|8 mg/kg Ramucirumab|Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.
11251945|NCT02564198|OG001|Outcome|12 mg/kg Ramucirumab|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251946|NCT02564198|OG002|Outcome|12 mg/kg Ramucirumab (Part B)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251947|NCT02564198|EG000|Reported Event|8 mg/kg Ramucirumab (Part A)|Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
11251948|NCT02564198|EG001|Reported Event|12 mg/kg Ramucirumab (Part A)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251949|NCT02564198|EG002|Reported Event|12 mg/kg Ramucirumab (Part B)|Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
11251950|NCT02564211|BG000|Baseline|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
11251951|NCT02564211|FG000|Participant Flow|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
11251952|NCT02564211|OG000|Outcome|Ipragliflozin|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
11251953|NCT02564211|EG000|Reported Event|Ipragliflozin 50 mg|Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.
11251954|NCT02564354|BG000|Baseline|Cohort 1: Homozygous for the F508del-CFTR Mutation|Subjects homozygous for the F508del-CFTR mutation were enrolled into Cohort 1 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251955|NCT02564354|BG001|Baseline|Cohort 2: Compound Heterozygous for the F508del-CFTR Mutation|Subjects compound heterozygous for the F508del-CFTR mutation were enrolled into Cohort 2 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251956|NCT02564354|BG002|Baseline|Total|Total of all reporting groups
11251957|NCT02564354|FG000|Participant Flow|Cohort 1: Homozygous for the F508del-CFTR Mutation|Subjects homozygous for the F508del-CFTR (Cystic Fibrosis Transmembrane conductance Regulator) mutation were enrolled into Cohort 1 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251958|NCT02564354|FG001|Participant Flow|Cohort 2: Compound Heterozygous for the F508del-CFTR Mutation|Subjects compound heterozygous for the F508del-CFTR mutation were enrolled into Cohort 2 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251959|NCT02564354|OG000|Outcome|Cohort 1: Homozygous for the F508del-CFTR Mutation|Subjects homozygous for the F508del-CFTR mutation were enrolled into Cohort 1 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251960|NCT02564354|OG001|Outcome|Cohort 2: Compound Heterozygous for the F508del-CFTR Mutation|Subjects compound heterozygous for the F508del-CFTR mutation were enrolled into Cohort 2 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251961|NCT02564354|EG000|Reported Event|Cohort 1: Homozygous for the F508del-CFTR Mutation|Subjects homozygous for the F508del-CFTR mutation were enrolled into Cohort 1 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251962|NCT02564354|EG001|Reported Event|Cohort 2: Compound Heterozygous for the F508del-CFTR Mutation|Subjects compound heterozygous for the F508del-CFTR mutation were enrolled into Cohort 2 and received QR-010 10 mg (5 mg/250 μL saline per nostril) via bilateral intranasal administration three times a week for 4 weeks for a total of 12 doses.
11251963|NCT02564432|BG000|Baseline|POP 10 Patient Cohort|Patient who are fitted with POP devices
11251964|NCT02564432|FG000|Participant Flow|Stomal and Skin Microbiota|Unilateral transfemoral amputees, who were fitted with a single percutaneous osseointegrated prosthetic device, were included in this study. The microbiota of the stoma (the skin exit site through which the percutaneous post protrudes) was sampled at defined time points for 16S (Svedberg unit) rRNA (ribosomal ribonucleic acid) and followed for 12 months, after the Stage 2-surgery. Microbiota from each patient's healthy ipsilateral thigh skin were used as controls. Thus, each patient had an internal control at each sampling point.
11251965|NCT02564432|OG000|Outcome|Stoma Microbiota|Patients implanted with POP devices
11251966|NCT02564432|OG001|Outcome|Healthy Thigh Skin Microbiota|Patient's thigh skin with and without POP implants (which proved to be the same and the ipsilateral thigh skin was used for final analysis)
11251967|NCT02564432|OG000|Outcome|Time to Reach a Stable Stomal Community Type|Overall, five Bacterial Community Types (CT1-5) were found to be present in the stomata at selected time points. These microbiota were generally temporarily unstable but with increasing time, following the Stage 2 surgery, some patients trended to a single Bacterial Community Type which was consistent until the end of the study (equilibrium).
11251968|NCT02564432|EG000|Reported Event|POP 10 Patient Cohort|Patients implanted with POP devices
11251969|NCT02564471|BG000|Baseline|Chloroquine|"Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base)~Chloroquine: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251970|NCT02564471|BG001|Baseline|Atovaquone and Proguanil (Malarone)|"Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Atovaquone and Proguanil: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251971|NCT02564471|BG002|Baseline|Doxycycline|"Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Doxycycline: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251972|NCT02564471|BG003|Baseline|Rabies|"RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Rabies Vaccine: FDA approve dosing schedule"
11251973|NCT02564471|BG004|Baseline|Total|Total of all reporting groups
11251974|NCT02564471|FG000|Participant Flow|Chloroquine|"Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base)~Chloroquine: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251975|NCT02564471|FG001|Participant Flow|Atovaquone and Proguanil (Malarone)|"Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Atovaquone and Proguanil: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251976|NCT02564471|FG002|Participant Flow|Doxycycline|"Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Doxycycline: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251977|NCT02564471|FG003|Participant Flow|Rabies|"RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Rabies Vaccine: FDA approve dosing schedule"
11251978|NCT02564471|OG000|Outcome|Chloroquine|"Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base)~Chloroquine: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251979|NCT02564471|OG001|Outcome|Atovaquone and Proguanil (Malarone)|"Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Atovaquone and Proguanil: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251980|NCT02564471|OG002|Outcome|Doxycycline|"Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Doxycycline: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251981|NCT02564471|OG003|Outcome|Rabies|"RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Rabies Vaccine: FDA approve dosing schedule"
11251982|NCT02564471|EG000|Reported Event|Chloroquine|"Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base)~Chloroquine: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251983|NCT02564471|EG001|Reported Event|Atovaquone and Proguanil (Malarone)|"Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Atovaquone and Proguanil: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251984|NCT02564471|EG002|Reported Event|Doxyclycline|"Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.~RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Doxycycline: FDA approve dosing schedule~Rabies Vaccine: FDA approve dosing schedule"
11251985|NCT02564471|EG003|Reported Event|Rabies|"RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.~Rabies Vaccine: FDA approve dosing schedule"
11251986|NCT02564497|BG000|Baseline|Process E Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
11251987|NCT02564497|BG001|Baseline|Process C Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
11251988|NCT02564497|BG002|Baseline|Total|Total of all reporting groups
11251989|NCT02564497|FG000|Participant Flow|Process E Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
11251990|NCT02564497|FG001|Participant Flow|Process C Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
11251991|NCT02564497|OG000|Outcome|Process E Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
11251992|NCT02564497|OG001|Outcome|Process C Belatacept|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
11251993|NCT02564497|EG000|Reported Event|Belatacept Process E|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
11251994|NCT02564497|EG001|Reported Event|Belatacept Process C|Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
11251995|NCT02564718|BG000|Baseline|Rivaroxaban (BAY59-7939) Suspension Bid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
11251996|NCT02564718|BG001|Baseline|Rivaroxaban (BAY59-7939) Suspension Tid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
11251997|NCT02564718|BG002|Baseline|Total|Total of all reporting groups
11251998|NCT02564718|FG000|Participant Flow|Rivaroxaban (BAY59-7939) Suspension Bid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
11251999|NCT02564718|FG001|Participant Flow|Rivaroxaban (BAY59-7939) Suspension Tid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
11252000|NCT02564718|OG000|Outcome|Rivaroxaban (BAY59-7939) Suspension Bid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
11252001|NCT02564718|OG001|Outcome|Rivaroxaban (BAY59-7939) Suspension Tid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
11252002|NCT02564718|EG000|Reported Event|Rivaroxaban (BAY59-7939) Suspension Bid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
11252003|NCT02564718|EG001|Reported Event|Rivaroxaban (BAY59-7939) Suspension Tid|Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
11252004|NCT02564887|BG000|Baseline|Traditional Therapy Only|"Standard of care therapy for qualifying population (with opportunity to crossover and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252005|NCT02564887|BG001|Baseline|Traditional Therapy With IOPI|"Standard of care therapy plus the addition of the IOPI instrument~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252006|NCT02564887|BG002|Baseline|Total|Total of all reporting groups
11252007|NCT02564887|FG000|Participant Flow|Traditional Therapy Only|"Standard of care therapy for qualifying population (with opportunity to crossover and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252008|NCT02564887|FG001|Participant Flow|Traditional Therapy With IOPI|"Standard of care therapy plus the addition of the IOPI instrument~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252009|NCT02564887|OG000|Outcome|Traditional Therapy Only|"Standard of care therapy for qualifying population (with opportunity to crossover and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance~Tongue strength was measured pre- and post-treatment with the Iowa Oral performance Instrument which measures linguapalatal pressure/force generation in kilopascals of pressure."
11252010|NCT02564887|OG001|Outcome|Traditional Therapy With IOPI|"Standard of care therapy plus the addition of the IOPI instrument~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance~Tongue strength was measured pre- and post-treatment with the Iowa Oral performance Instrument which measures linguapalatal pressure/force generation in kilopascals of pressure."
11252011|NCT02564887|OG000|Outcome|Traditional Therapy Only|"Standard of care therapy for qualifying population (with opportunity to crossover and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252012|NCT02564887|OG001|Outcome|Traditional Therapy With IOPI|"Standard of care therapy plus the addition of the IOPI instrument~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252013|NCT02564887|EG000|Reported Event|Traditional Therapy Only|"Standard of care therapy for qualifying population (with opportunity to crossover and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252014|NCT02564887|EG001|Reported Event|Traditional Therapy With IOPI|"Standard of care therapy plus the addition of the IOPI instrument~Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance"
11252015|NCT02564926|BG000|Baseline|Dapagliflozin|Dapagliflozin 10mg + Metformin 1000mg
11252016|NCT02564926|BG001|Baseline|Glimepiride|Glimepiriide 1-2mg + Metformin 1000mg
11252017|NCT02564926|BG002|Baseline|Total|Total of all reporting groups
11252018|NCT02564926|FG000|Participant Flow|Dapagliflozin|Dapagliflozin 10mg + Metformin 1000mg
11252019|NCT02564926|FG001|Participant Flow|Glimepiride|Glimepiriide 1-2mg + Metformin 1000mg
11252020|NCT02564926|OG000|Outcome|Dapagliflozin|Dapagliflozin 10mg + Metformin 1000mg
11252021|NCT02564926|OG001|Outcome|Glimepiride|Glimepiriide 1-2mg + Metformin 1000mg
11252022|NCT02564926|EG000|Reported Event|Dapagliflozin|Dapagliflozin 10mg + Metformin 1000mg
11252023|NCT02564926|EG001|Reported Event|Glimepiride|Glimepiriide 1-2mg + Metformin 1000mg
11252024|NCT02564952|BG000|Baseline|GWP42003-P|"Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.~CLB was administered in line with the physician's preferred CLB dosing regimen for each participant."
11252025|NCT02564952|FG000|Participant Flow|GWP42003-P|"Participants who transferred from the double blind (DB) phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.~Clobazam (CLB) was administered in line with the physician's preferred CLB dosing regimen for each participant."
11252026|NCT02564952|OG000|Outcome|GWP42003-P|"Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.~CLB was administered in line with the physician's preferred CLB dosing regimen for each participant."
11252027|NCT02564952|EG000|Reported Event|GWP42003-P|"Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.~CLB was administered in line with the physician's preferred CLB dosing regimen for each participant."
11252028|NCT02565108|BG000|Baseline|GWP42003-P 20 mg/kg/Day Dose|"Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252029|NCT02565108|BG001|Baseline|Placebo|"Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252030|NCT02565108|BG002|Baseline|Total|Total of all reporting groups
11252031|NCT02565108|FG000|Participant Flow|GWP42003-P 20 mg/kg/Day Dose|"Participants received GWP42003-P 20 milligrams (mg)/kilogram (kg)/day orally, twice daily immediately after their clobazam (CLB) dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the open-label extension (OLE) or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an Investigational Medicinal Product (IMP), for the duration of this study."
11252032|NCT02565108|FG001|Participant Flow|Placebo|"Participants received placebo (0 mg/milliliter [mL] GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252033|NCT02565108|OG000|Outcome|GWP42003-P 20 mg/kg/Day Dose|"Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252034|NCT02565108|OG001|Outcome|Placebo|"Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252035|NCT02565108|EG000|Reported Event|GWP42003-P 20 mg/kg/Day Dose|"Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252036|NCT02565108|EG001|Reported Event|Placebo|"Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.~All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study."
11252037|NCT02565147|BG000|Baseline|PPCI With Bivalirudin|Bivalirudin was administered as a bolus (0.75 mg/kg) and an infusion (1.75 mg/kg/h) for the duration of the PPCI and continued for the first 4 h after completion of the procedure.
11252038|NCT02565147|BG001|Baseline|PPCI With Heparin|UFH was administered as a bolus according to standard of care for completion of PPCI per site. An ACT ≥250 s at the end of the procedure was recommended.
11252039|NCT02565147|BG002|Baseline|Total|Total of all reporting groups
11252040|NCT02565147|FG000|Participant Flow|PPCI With Bivalirudin|Bivalirudin was administered as a bolus (0.75 milligrams [mg]/kilogram [kg]) and an infusion (1.75 mg/kg/hours [h]) for the duration of the PPCI and continued for the first 4 h after completion of the procedure.
11252041|NCT02565147|FG001|Participant Flow|PPCI With Heparin|Unfractionated heparin (UFH) was administered as a bolus according to standard of care for completion of PPCI per site. An activated clotting time (ACT) ≥250 seconds (s) at the end of the procedure was recommended.
11252042|NCT02565147|OG000|Outcome|PPCI With Bivalirudin|Bivalirudin was administered as a bolus (0.75 mg/kg) and an infusion (1.75 mg/kg/h) for the duration of the PPCI and continued for the first 4 h after completion of the procedure.
11252043|NCT02565147|OG001|Outcome|PPCI With Heparin|UFH was administered as a bolus according to standard of care for completion of PPCI per site. An ACT ≥250 s at the end of the procedure was recommended.
11252044|NCT02565147|EG000|Reported Event|PPCI With Bivalirudin|Bivalirudin was administered as a bolus (0.75 mg/kg) and an infusion (1.75 mg/kg/h) for the duration of the PPCI and continued for the first 4 h after completion of the procedure.
11252045|NCT02565147|EG001|Reported Event|PPCI With Heparin|UFH was administered as a bolus according to standard of care for completion of PPCI per site. An ACT ≥250 s at the end of the procedure was recommended.
11252046|NCT02565186|BG000|Baseline|Lasmiditan 100mg|Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252047|NCT02565186|BG001|Baseline|Lasmiditan 200mg|Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252048|NCT02565186|BG002|Baseline|Total|Total of all reporting groups
11252049|NCT02565186|FG000|Participant Flow|Lasmiditan 100mg|Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252050|NCT02565186|FG001|Participant Flow|Lasmiditan 200mg|Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252051|NCT02565186|OG000|Outcome|Lasmiditan 100mg|Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252052|NCT02565186|OG001|Outcome|Lasmiditan 200mg|Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252053|NCT02565186|EG000|Reported Event|Lasmiditan 100mg|Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252054|NCT02565186|EG001|Reported Event|Lasmiditan 200mg|Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
11252055|NCT02565381|BG000|Baseline|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
11252056|NCT02565381|BG001|Baseline|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
11252057|NCT02565381|BG002|Baseline|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
11252058|NCT02565381|BG003|Baseline|Total|Total of all reporting groups
11252059|NCT02565381|FG000|Participant Flow|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
11252060|NCT02565381|FG001|Participant Flow|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
11252061|NCT02565381|FG002|Participant Flow|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
11252062|NCT02565381|OG000|Outcome|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
11252063|NCT02565381|OG001|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
11252064|NCT02565381|OG002|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
11252065|NCT02565381|EG000|Reported Event|Control (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
11252066|NCT02565381|EG001|Reported Event|Financial Rewards (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Contingent financial rewards for smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
11252067|NCT02565381|EG002|Reported Event|Text Messaging (N=25)|"Transdermal nicotine patch~In-person smoking cessation counseling~Text messages to support smoking abstinence~Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks~- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks~In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks~Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
11252068|NCT02565485|BG000|Baseline|Standard IV Preload|Patients in this arm will receive 500mL of Lactated Ringer's solution, which is the standard IV fluid preload used on Labor and Delivery at MetroHealth Medical Center
11252069|NCT02565485|BG001|Baseline|Volume Replacement IV Preload|"Patients in this arm will receive 1500mL of Lactated Ringer's solution~Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration"
11252070|NCT02565485|BG002|Baseline|Total|Total of all reporting groups
11252071|NCT02565485|FG000|Participant Flow|Standard IV Preload|Patients in this arm will receive 500mL of Lactated Ringer's solution, which is the standard IV fluid preload used on Labor and Delivery at MetroHealth Medical Center
11252072|NCT02565485|FG001|Participant Flow|Volume Replacement IV Preload|"Patients in this arm will receive 1500mL of Lactated Ringer's solution~Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration"
11252073|NCT02565485|OG000|Outcome|Standard IV Preload|Patients in this arm will receive 500mL of Lactated Ringer's solution, which is the standard IV fluid preload used on Labor and Delivery at MetroHealth Medical Center
11252074|NCT02565485|OG001|Outcome|Volume Replacement IV Preload|"Patients in this arm will receive 1500mL of Lactated Ringer's solution~Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration"
11252075|NCT02565485|EG000|Reported Event|Standard IV Preload|Patients in this arm will receive 500mL of Lactated Ringer's solution, which is the standard IV fluid preload used on Labor and Delivery at MetroHealth Medical Center
11252076|NCT02565485|EG001|Reported Event|Volume Replacement IV Preload|"Patients in this arm will receive 1500mL of Lactated Ringer's solution~Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration"
11252077|NCT02565511|BG000|Baseline|Cohort I (CI) CAD106|CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252078|NCT02565511|BG001|Baseline|Cohort I (CI) CAD106 Placebo|Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252079|NCT02565511|BG002|Baseline|Cohort II (CII) CNP520|CNP520 (50 mg) capsules taken once daily orally
11252080|NCT02565511|BG003|Baseline|Cohort II (CII) CNP520 Placebo|Placebo to CNP520 capsules taken once daily orally
11252081|NCT02565511|BG004|Baseline|Total|Total of all reporting groups
11252082|NCT02565511|FG000|Participant Flow|Cohort I (CI) CAD106|CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252083|NCT02565511|FG001|Participant Flow|Cohort I (CI) CAD106 Placebo|Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252084|NCT02565511|FG002|Participant Flow|Cohort II (CII) CNP520|CNP520 (50 mg) capsules taken once daily orally
11252085|NCT02565511|FG003|Participant Flow|Cohort II (CII) CNP520 Placebo|Placebo to CNP520 capsules taken once daily orally
11252086|NCT02565511|OG000|Outcome|Cohort I (CI) CAD106|CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252087|NCT02565511|OG001|Outcome|Cohort I (CI) CAD106 Placebo|Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
11252088|NCT02565511|OG002|Outcome|Cohort II (CII) CNP520|CNP520 (50 mg) capsules taken once daily orally
11252089|NCT02565511|OG003|Outcome|Cohort II (CII) CNP520 Placebo|Placebo to CNP520 capsules taken once daily orally
11252090|NCT02565511|EG000|Reported Event|Cohort I @CAD106|Cohort I @CAD106
11252091|NCT02565511|EG001|Reported Event|Cohort I @Placebo|Cohort I @Placebo
11252092|NCT02565511|EG002|Reported Event|Cohort II (CNP520 50)|CNP520 (50 mg) capsules taken once daily orally
11252093|NCT02565511|EG003|Reported Event|Cohort II Placebo|Cohort II @Placebo
11252094|NCT02565576|BG000|Baseline|CFZ533|CFZ533 10 mg/kg
11252095|NCT02565576|BG001|Baseline|Placebo|Placebo
11252096|NCT02565576|BG002|Baseline|Total|Total of all reporting groups
11252097|NCT02565576|FG000|Participant Flow|CFZ533|CFZ533 10 mg/kg
11252098|NCT02565576|FG001|Participant Flow|Placebo|Placebo
11252099|NCT02565576|OG000|Outcome|CFZ533|CFZ533 10 mg/kg
11252100|NCT02565576|OG001|Outcome|Placebo|Placebo
11252101|NCT02565576|EG000|Reported Event|CFZ533 10 mg/kg IV Infusion|CFZ533 10 mg/kg IV infusion
11252102|NCT02565576|EG001|Reported Event|Placebo IV Infusion|Placebo IV infusion
11252103|NCT02565615|BG000|Baseline|Atorvastatin <=10 mg|Participants received Atorvastatin <=10 mg daily according to doctor's prescription.
11252104|NCT02565615|BG001|Baseline|Atorvastatin 20 mg|Participants received Atorvastatin 20 mg daily according to doctor's prescription.
11252105|NCT02565615|BG002|Baseline|Atorvastatin 30 mg|Participants received Atorvastatin 30 mg daily according to doctor's prescription.
11252106|NCT02565615|BG003|Baseline|Atorvastatin 40 mg|Participants received Atorvastatin 40 mg daily according to doctor's prescription.
11252107|NCT02565615|BG004|Baseline|Atorvastatin Unknown Dosage|Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
11252108|NCT02565615|BG005|Baseline|Total|Total of all reporting groups
11252109|NCT02565615|FG000|Participant Flow|Atorvastatin <=10 mg|Participants received Atorvastatin <=10 mg daily according to doctor's prescription.
11252110|NCT02565615|FG001|Participant Flow|Atorvastatin 20 mg|Participants received Atorvastatin 20 mg daily according to doctor's prescription.
11252111|NCT02565615|FG002|Participant Flow|Atorvastatin 30 mg|Participants received Atorvastatin 30 mg daily according to doctor's prescription.
11252112|NCT02565615|FG003|Participant Flow|Atorvastatin 40 mg|Participants received Atorvastatin 40 mg daily according to doctor's prescription.
11252113|NCT02565615|FG004|Participant Flow|Atorvastatin Unknown Dosage|Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
11252114|NCT02565615|OG000|Outcome|Atorvastatin <=10 mg|Participants received Atorvastatin <=10 mg daily according to doctor's prescription.
11252115|NCT02565615|OG001|Outcome|Atorvastatin 20 mg|Participants received Atorvastatin 20 mg daily according to doctor's prescription.
11252116|NCT02565615|OG002|Outcome|Atorvastatin 30 mg|Participants received Atorvastatin 30 mg daily according to doctor's prescription.
11252117|NCT02565615|OG003|Outcome|Atorvastatin 40 mg|Participants received Atorvastatin 40 mg daily according to doctor's prescription.
11252118|NCT02565615|OG004|Outcome|Atorvastatin Unknown Dosage|Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
11252119|NCT02565615|EG000|Reported Event|Atorvastatin <=10 mg|Participants received Atorvastatin <=10 mg daily according to doctor's prescription.
11252120|NCT02565615|EG001|Reported Event|Atorvastatin 20 mg|Participants received Atorvastatin 20 mg daily according to doctor's prescription.
11252121|NCT02565615|EG002|Reported Event|Atorvastatin 30 mg|Participants received Atorvastatin 30 mg daily according to doctor's prescription.
11252122|NCT02565615|EG003|Reported Event|Atorvastatin 40 mg|Participants received Atorvastatin 40 mg daily according to doctor's prescription.
11252123|NCT02565615|EG004|Reported Event|Atorvastatin Unknown Dosage|Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
11252124|NCT02565628|BG000|Baseline|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252125|NCT02565628|BG001|Baseline|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252126|NCT02565628|BG002|Baseline|Total|Total of all reporting groups
11252127|NCT02565628|FG000|Participant Flow|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252128|NCT02565628|FG001|Participant Flow|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252129|NCT02565628|OG000|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252130|NCT02565628|OG001|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252131|NCT02565628|EG000|Reported Event|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252132|NCT02565628|EG001|Reported Event|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
11252133|NCT02565706|BG000|Baseline|WIC Fresh Start Program|"Participants in this arm receive the Fresh Start program.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252134|NCT02565706|BG001|Baseline|Existing Online Health Education|"Participants in this arm receive existing online WIC health education.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252135|NCT02565706|BG002|Baseline|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11341840|NCT03689504|BG000|Baseline|Standard of Care|"The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents."
11252136|NCT02565706|BG003|Baseline|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252137|NCT02565706|BG004|Baseline|Total|Total of all reporting groups
11252138|NCT02565706|FG000|Participant Flow|WIC Fresh Start Program|"Participants in this arm receive the Fresh Start program.~The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Fresh Start Program: The intervention is an online lesson to promote farmers' market fruit and vegetable (FV) purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252139|NCT02565706|FG001|Participant Flow|Existing Online Health Education|"Participants in this arm receive existing online WIC health education.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252140|NCT02565706|FG002|Participant Flow|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252141|NCT02565706|FG003|Participant Flow|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252142|NCT02565706|OG000|Outcome|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252143|NCT02565706|OG001|Outcome|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252144|NCT02565706|OG000|Outcome|WIC Fresh Start Program|"Participants in this arm receive the Fresh Start program.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252145|NCT02565706|OG001|Outcome|Existing Online Health Education|"Participants in this arm receive existing online WIC health education.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252146|NCT02565706|OG002|Outcome|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252147|NCT02565706|OG003|Outcome|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11341863|NCT03691779|FG001|Participant Flow|Part B: ELX/TEZ/IVA|Participants in Part B weighing less than (<) 30 kilograms (kg) at Day 1 received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h and participants weighing greater than equals to (>=) 30 kg at Day 1 received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11252148|NCT02565706|OG000|Outcome|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program (includes those who receive WIC Farmers' Market Nutrition Program [FMNP] vouchers and those who do not).~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252149|NCT02565706|OG001|Outcome|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education (includes those who receive WIC Farmers' Market Nutrition Program [FMNP] vouchers and those who do not).~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252150|NCT02565706|OG002|Outcome|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252151|NCT02565706|EG000|Reported Event|WIC Fresh Start Program|"Participants in this arm receive the Fresh Start program.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252152|NCT02565706|EG001|Reported Event|Existing Online Health Education|"Participants in this arm receive existing online WIC health education.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252153|NCT02565706|EG002|Reported Event|WIC Fresh Start Program (FMNP)|"Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~WIC Fresh Start Program: The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills."
11252154|NCT02565706|EG003|Reported Event|Existing Online Health Education (FMNP)|"Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.~Existing Online Health Education: Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson."
11252155|NCT02565784|BG000|Baseline|Intradermal Injection|"Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252156|NCT02565784|FG000|Participant Flow|Intradermal Injection|"Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252157|NCT02565784|OG000|Outcome|Intradermal Injection|"Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252158|NCT02565784|OG000|Outcome|Right Nasolabial Fold|"Intradermal injection~Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252159|NCT02565784|OG001|Outcome|Left Nasolabial Fold|"Intradermal injection~Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252160|NCT02565784|OG000|Outcome|Right Upper Cheek|"Intradermal injection~Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252161|NCT02565784|OG001|Outcome|Left Upper Cheek|"Intradermal injection~Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252162|NCT02565784|EG000|Reported Event|Intradermal Injection|"Restylane and/or Perlane~Restylane: Facial tissue augmentation~Perlane: Facial tissue augmentation"
11252163|NCT02565810|BG000|Baseline|SB5 40mg|Adalimumab PFS and Pen
11252164|NCT02565810|FG000|Participant Flow|SB5 40mg|Adalimumab PFS and Pen
11252165|NCT02565810|OG000|Outcome|SB5 Pen/PFS|Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10
11252166|NCT02565810|OG000|Outcome|Week 2 (SB5 40 mg PFS)|40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.
11252167|NCT02565810|OG001|Outcome|Week 6 (SB5 40 mg Pen)|40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.
11252168|NCT02565810|OG000|Outcome|SB5 PFS|Subject preference for the PFS at Week 6
11252169|NCT02565810|OG001|Outcome|SB5 Pen|Subject preference for the Pen at Week 6
11252170|NCT02565810|OG002|Outcome|No Preference|Subject who chose 'no preference' at Week 6
11252171|NCT02565810|EG000|Reported Event|SB5 40mg|Adalimumab PFS and Pen
11341864|NCT03691779|OG000|Outcome|Part A: ELX/TEZ/IVA|Participants in Part A received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h in the treatment period for 15 days.
11252172|NCT02565901|BG000|Baseline|Arm I (Sirolimus, Docetaxel, Carboplatin)|"Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252173|NCT02565901|BG001|Baseline|Arm II (Sirolimus, Docetaxel, Carboplatin)|"Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252174|NCT02565901|BG002|Baseline|Phase 1 Group|Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
11252175|NCT02565901|BG003|Baseline|Total|Total of all reporting groups
11252176|NCT02565901|FG000|Participant Flow|Arm I (Sirolimus, Docetaxel, Carboplatin)|"Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252177|NCT02565901|FG001|Participant Flow|Arm II (Sirolimus, Docetaxel, Carboplatin)|"Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252178|NCT02565901|FG002|Participant Flow|Phase 1 Group|Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
11252179|NCT02565901|OG000|Outcome|Arm I (Sirolimus, Docetaxel, Carboplatin)|"Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Sirolimus: Given PO"
11252180|NCT02565901|OG001|Outcome|Arm II (Sirolimus, Docetaxel, Carboplatin)|"Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252181|NCT02565901|OG000|Outcome|Arm I (Sirolimus, Docetaxel, Carboplatin)|"Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252182|NCT02565901|OG002|Outcome|Phase 1 Group|Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
11252183|NCT02565901|EG000|Reported Event|Arm I (Sirolimus, Docetaxel, Carboplatin)|"Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252184|NCT02565901|EG001|Reported Event|Arm II (Sirolimus, Docetaxel, Carboplatin)|"Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Sirolimus: Given PO"
11252185|NCT02565901|EG002|Reported Event|Phase 1 Group|Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
11252186|NCT02566005|BG000|Baseline|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
11252187|NCT02566005|BG001|Baseline|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
11252188|NCT02566005|BG002|Baseline|Total|Total of all reporting groups
11252189|NCT02566005|FG000|Participant Flow|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
11337707|NCT03591406|FG001|Participant Flow|Iron Sucrose (IS)|"Participants treated with IS given by IV injection or drip infusion~Dosage Form: Sterile solution for injection containing 2% w/v iron~Strength: 5 mL ampoules containing 100 mg iron per ampoule~Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given~Route of administration: IV injection or drip infusion~Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose."
11252190|NCT02566005|FG001|Participant Flow|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
11252191|NCT02566005|OG000|Outcome|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
11252192|NCT02566005|OG001|Outcome|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
11252193|NCT02566005|EG000|Reported Event|Misoprostol Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist.)
11252194|NCT02566005|EG001|Reported Event|Misoprostol and Foley Bulb Group|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. In addition, a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.
11252195|NCT02566031|BG000|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
11252196|NCT02566031|BG001|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
11252197|NCT02566031|BG002|Baseline|Total|Total of all reporting groups
11252198|NCT02566031|FG000|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
11252199|NCT02566031|FG001|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
11252200|NCT02566031|OG000|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
11252201|NCT02566031|OG001|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
11252202|NCT02566031|EG000|Reported Event|Indacaterol and Glycopyrronium (QVA149|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
11252203|NCT02566031|EG001|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
11252204|NCT02566031|EG002|Reported Event|Total|Total
11252205|NCT02566044|BG000|Baseline|Cohort 1 QBW276|QBW276 3mg bid
11252206|NCT02566044|BG001|Baseline|Cohort 2 QBW276|QBW276 6mg bid
11252207|NCT02566044|BG002|Baseline|Placebo|Placebo to QBW276 dose 3mg bid Cohort 1, and Placebo to QBW276 dose 6mg bid Cohort 2.
11252208|NCT02566044|BG003|Baseline|Total|Total of all reporting groups
11252209|NCT02566044|FG000|Participant Flow|Cohort 1 QBW276|QBW276 3mg bid
11252210|NCT02566044|FG001|Participant Flow|Cohort 2 QBW276|QBW276 6mg bid
11252211|NCT02566044|FG002|Participant Flow|Placebo|Placebo to QBW276 dose 3mg bid Cohort 1, and Placebo to QBW276 dose 6mg bid Cohort 2.
11252212|NCT02566044|OG000|Outcome|Cohort 1 QBW276|QBW276 3mg bid
11252213|NCT02566044|OG001|Outcome|Cohort 2 QBW276|QBW276 6mg bid
11252214|NCT02566044|OG002|Outcome|Placebo|Placebo to QBW276 dose 3mg bid Cohort 1, and Placebo to QBW276 dose 6mg bid Cohort 2.
11252215|NCT02566044|OG001|Outcome|Cohort 1 QBP545|formation of metabolites QBP545
11252216|NCT02566044|OG002|Outcome|Cohort 1 QBV697|formation of metabolites QBV697
11252217|NCT02566044|OG003|Outcome|Cohort 2 QBW276|QBW276 6mg bid
11252218|NCT02566044|OG004|Outcome|Cohort 2 QBP545|formation of metabolites QBP545
11252219|NCT02566044|OG005|Outcome|Cohort 2 QBV697|formation of metabolites QBV697
11252220|NCT02566044|EG000|Reported Event|Cohort 1 QBW276|QBW276 3 mg bid
11252221|NCT02566044|EG001|Reported Event|Cohort 2 QBW276|QBW276 6 mg bid
11252222|NCT02566044|EG002|Reported Event|Placebo|Placebo to QBW276 dose 3mg bid Cohort 1, and Placebo to QBW276 dose 6mg bid Cohort 2.
11252223|NCT02566083|BG000|Baseline|Toric IOL|Experimental (ZCT300, ZCT400)
11252224|NCT02566083|BG001|Baseline|Non-toric IOL|Control (ZCB00)
11252225|NCT02566083|BG002|Baseline|Total|Total of all reporting groups
11252226|NCT02566083|FG000|Participant Flow|Toric IOL|Experimental (ZCT300, ZCT400)
11252227|NCT02566083|FG001|Participant Flow|Non-toric IOL|Control (ZCB00)
11252228|NCT02566083|OG000|Outcome|Toric IOL|Experimental (ZCT300, ZCT400)
11252229|NCT02566083|OG001|Outcome|Non-toric IOL|Control (ZCB00)
11252230|NCT02566083|EG000|Reported Event|Toric IOL|Experimental (ZCT300, ZCT400)
11252231|NCT02566083|EG001|Reported Event|Non-toric IOL|Control (ZCB00)
11252232|NCT02566109|BG000|Baseline|Fast MRI|"All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.~Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment."
11252233|NCT02566109|FG000|Participant Flow|Fast MRI|"All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.~Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment."
11252234|NCT02566109|OG000|Outcome|Fast MRI|"All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.~Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment."
11252235|NCT02566109|EG000|Reported Event|Fast MRI|"All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.~Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment."
11252236|NCT02566135|BG000|Baseline|Group-I|"In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."
11252237|NCT02566135|BG001|Baseline|Group-C|"In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."
11252238|NCT02566135|BG002|Baseline|Total|Total of all reporting groups
11252239|NCT02566135|FG000|Participant Flow|Group-I|"In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."
11252240|NCT02566135|FG001|Participant Flow|Group-C|"In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."
11252241|NCT02566135|OG000|Outcome|Group-I|"In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."
11252242|NCT02566135|OG001|Outcome|Group-C|"In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."
11252243|NCT02566135|EG000|Reported Event|Group-I|"In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."
11252244|NCT02566135|EG001|Reported Event|Group-C|"In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.~Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."
11252245|NCT02566239|BG000|Baseline|Shared Data|"Share activity data with care team.~Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.~Share activity data with care team: Share participant in-home activity data with retirement community care team."
11252246|NCT02566239|BG001|Baseline|Non-shared Data|"Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors."
11252247|NCT02566239|BG002|Baseline|Total|Total of all reporting groups
11252248|NCT02566239|FG000|Participant Flow|Shared Data|"Share activity data with care team.~Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.~Share activity data with care team: Share participant in-home activity data with retirement community care team."
11252249|NCT02566239|FG001|Participant Flow|Non-shared Data|"Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors."
11252250|NCT02566239|OG000|Outcome|Shared Data|"Share activity data with care team.~Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.~Share activity data with care team: Share participant in-home activity data with retirement community care team."
11252251|NCT02566239|OG001|Outcome|Non-shared Data|"Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors."
11252252|NCT02566239|EG000|Reported Event|Shared Data|"Share activity data with care team.~Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.~Share activity data with care team: Share participant in-home activity data with retirement community care team."
11252253|NCT02566239|EG001|Reported Event|Non-shared Data|"Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool.~This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors."
11252254|NCT02566265|BG000|Baseline|Fluzone High Dose Vaccine Then Fluzone High Dose Booster|"Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.~Fluzone High Dose Vaccine"
11252255|NCT02566265|BG001|Baseline|Standard of Care|"Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.~Standard of care/Placebo"
11252256|NCT02566265|BG002|Baseline|Total|Total of all reporting groups
11252257|NCT02566265|FG000|Participant Flow|Fluzone High Dose Vaccine Then Fluzone High Dose Booster|"Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.~Fluzone High Dose Vaccine"
11252258|NCT02566265|FG001|Participant Flow|Standard of Care|"Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.~Standard of care/Placebo"
11252259|NCT02566265|OG000|Outcome|Fluzone High Dose Vaccine Then Fluzone High Dose Booster|"Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.~Fluzone High Dose Vaccine"
11252260|NCT02566265|OG001|Outcome|Standard of Care|"Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.~Standard of care/Placebo"
11252261|NCT02566265|EG000|Reported Event|Fluzone High Dose Vaccine Then Fluzone High Dose Booster|"Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.~Fluzone High Dose Vaccine"
11252262|NCT02566265|EG001|Reported Event|Standard of Care|"Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.~Standard of care/Placebo"
11252263|NCT02566317|BG000|Baseline|MOVE+|"A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace.~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252264|NCT02566317|BG001|Baseline|STAND+|"Move intervention (A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace) plus the installation of a sit-stand workstation.~Sit-Stand workstation: Installation of a sit-stand desk at work~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252265|NCT02566317|BG002|Baseline|Total|Total of all reporting groups
11252266|NCT02566317|FG000|Participant Flow|MOVE+|"A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace.~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252267|NCT02566317|FG001|Participant Flow|STAND+|"Move intervention (A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace) plus the installation of a sit-stand workstation.~Sit-Stand workstation: Installation of a sit-stand desk at work~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252268|NCT02566317|OG000|Outcome|MOVE+|"A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace.~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252269|NCT02566317|OG001|Outcome|STAND+|"Move intervention (A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace) plus the installation of a sit-stand workstation.~Sit-Stand workstation: Installation of a sit-stand desk at work~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252270|NCT02566317|EG000|Reported Event|MOVE+|"A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace.~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252271|NCT02566317|EG001|Reported Event|STAND+|"Move intervention (A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace) plus the installation of a sit-stand workstation.~Sit-Stand workstation: Installation of a sit-stand desk at work~Move: A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace"
11252272|NCT02566369|BG000|Baseline|CD5789 (Trifarotene) 50μg/g Cream|CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
11252273|NCT02566369|BG001|Baseline|Placebo Cream|Placebo cream applied once daily for 12 weeks
11252274|NCT02566369|BG002|Baseline|Total|Total of all reporting groups
11252275|NCT02566369|FG000|Participant Flow|CD5789 (Trifarotene) 50μg/g Cream|CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
11252276|NCT02566369|FG001|Participant Flow|Placebo Cream|Placebo cream applied once daily for 12 weeks
11252277|NCT02566369|OG000|Outcome|CD5789 (Trifarotene) 50μg/g Cream|CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
11252278|NCT02566369|OG001|Outcome|Placebo Cream|Placebo cream applied once daily for 12 weeks
11252279|NCT02566369|EG000|Reported Event|CD5789 (Trifarotene) 50μg/g Cream|CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
11252280|NCT02566369|EG001|Reported Event|Placebo Cream|Placebo cream applied once daily for 12 weeks
11252281|NCT02566525|BG000|Baseline|CytoSorb Device|"Standard of care plus treatment with CytSorb device installed on the CPB machine~CytoSorb: Cytosorb device use during cardiopulmonary bypass"
11252282|NCT02566525|BG001|Baseline|Control|Standard of care
11252283|NCT02566525|BG002|Baseline|Total|Total of all reporting groups
11252284|NCT02566525|FG000|Participant Flow|CytoSorb Device|"Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine~CytoSorb: Cytosorb device use during cardiopulmonary bypass"
11252285|NCT02566525|FG001|Participant Flow|Control|Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
11252286|NCT02566525|OG000|Outcome|CytoSorb Device|"Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine~CytoSorb: Cytosorb device use during cardiopulmonary bypass"
11252287|NCT02566525|OG001|Outcome|Control|Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
11252288|NCT02566525|OG000|Outcome|CytoSorb Device|"Standard of care plus treatment with CytSorb device installed on the CPB machine~CytoSorb: Cytosorb device use during cardiopulmonary bypass"
11252289|NCT02566525|OG001|Outcome|Control|Standard of care
11252290|NCT02566525|EG000|Reported Event|CytoSorb Device|"Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine~CytoSorb: Cytosorb device use during cardiopulmonary bypass"
11252291|NCT02566525|EG001|Reported Event|Control|Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
11252292|NCT02566577|BG000|Baseline|Fresh RBC Transfusion/Storage-aged RBC Transfusion|Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11341865|NCT03691779|OG000|Outcome|Part B: ELX/TEZ/IVA|Participants in Part B weighing <30 kg at Day 1 received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h and participants weighing >=30 kg at Day 1 received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11252293|NCT02566577|BG001|Baseline|Storage-aged RBC Transfusion/Fresh RBC Transfusion|Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11252294|NCT02566577|BG002|Baseline|Total|Total of all reporting groups
11252295|NCT02566577|FG000|Participant Flow|Fresh RBC Transfusion/Storage-aged RBC Transfusion|"Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.~Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit."
11252296|NCT02566577|FG001|Participant Flow|Storage-aged RBC Transfusion/Fresh RBC Transfusion|"Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.~Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit."
11252297|NCT02566577|OG000|Outcome|Fresh RBC Transfusion/Storage-aged RBC Transfusion|"Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.~Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit."
11252298|NCT02566577|OG001|Outcome|Storage-aged RBC Transfusion/Fresh RBC Transfusion|"Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.~Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit."
11252299|NCT02566577|OG000|Outcome|Fresh RBC Transfusion/Storage-aged RBC Transfusion|Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11252300|NCT02566577|OG001|Outcome|Storage-aged RBC Transfusion/Fresh RBC Transfusion|Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11252301|NCT02566577|EG000|Reported Event|Fresh RBC Transfusion/Storage-aged RBC Transfusion|Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11252302|NCT02566577|EG001|Reported Event|Storage-aged RBC Transfusion/Fresh RBC Transfusion|Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
11252303|NCT02566590|BG000|Baseline|Control|"Participants will complete bed rest but will receive a non-protein placebo supplement~non-protein placebo supplement: supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest."
11252304|NCT02566590|BG001|Baseline|NMES + PRO|"Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink.~NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest.~Protein: supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest."
11252305|NCT02566590|BG002|Baseline|Total|Total of all reporting groups
11252306|NCT02566590|FG000|Participant Flow|Control|"Participants will complete bed rest but will receive a non-protein placebo supplement~non-protein placebo supplement: supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest."
11252307|NCT02566590|FG001|Participant Flow|NMES + PRO|"Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink.~NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest.~Protein: supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest."
11252308|NCT02566590|OG000|Outcome|Control|"Participants will complete bed rest but will receive a non-protein placebo supplement~non-protein placebo supplement: supplement will be used as a placebo for control participants. The supplement will be provided 3x a day during bed rest."
11252309|NCT02566590|OG001|Outcome|NMES + PRO|"Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink.~NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during each day of bed rest.~Protein (PRO): supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during each day of bed rest."
11252310|NCT02566590|EG000|Reported Event|Control|"Participants will complete bed rest but will receive a non-protein placebo supplement~non-protein placebo supplement: supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest."
11252311|NCT02566590|EG001|Reported Event|NMES + PRO|"Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink.~NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest.~Protein: supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest."
11252312|NCT02566759|BG000|Baseline|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
11252313|NCT02566759|BG001|Baseline|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
11252314|NCT02566759|BG002|Baseline|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
11252315|NCT02566759|BG003|Baseline|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
11252316|NCT02566759|BG004|Baseline|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
11252317|NCT02566759|BG005|Baseline|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
11252318|NCT02566759|BG006|Baseline|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
11252319|NCT02566759|BG007|Baseline|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
11252320|NCT02566759|BG008|Baseline|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252321|NCT02566759|BG009|Baseline|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252322|NCT02566759|BG010|Baseline|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252323|NCT02566759|BG011|Baseline|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252324|NCT02566759|BG012|Baseline|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
11252325|NCT02566759|BG013|Baseline|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252326|NCT02566759|BG014|Baseline|Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
11252327|NCT02566759|BG015|Baseline|Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
11252328|NCT02566759|BG016|Baseline|Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)|TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11252329|NCT02566759|BG017|Baseline|Total|Total of all reporting groups
11252330|NCT02566759|FG000|Participant Flow|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
11252331|NCT02566759|FG001|Participant Flow|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
11252332|NCT02566759|FG002|Participant Flow|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
11252333|NCT02566759|FG003|Participant Flow|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
11252334|NCT02566759|FG004|Participant Flow|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
11252335|NCT02566759|FG005|Participant Flow|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
11252336|NCT02566759|FG006|Participant Flow|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
11252337|NCT02566759|FG007|Participant Flow|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
11252338|NCT02566759|FG008|Participant Flow|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252339|NCT02566759|FG009|Participant Flow|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252340|NCT02566759|FG010|Participant Flow|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252341|NCT02566759|FG011|Participant Flow|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252342|NCT02566759|FG012|Participant Flow|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
11252343|NCT02566759|FG013|Participant Flow|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252344|NCT02566759|FG014|Participant Flow|Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
11252345|NCT02566759|FG015|Participant Flow|Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)|TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
11252346|NCT02566759|FG016|Participant Flow|Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)|TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11252347|NCT02566759|OG000|Outcome|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
11252348|NCT02566759|OG001|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
11252349|NCT02566759|OG002|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
11252350|NCT02566759|OG003|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
11252351|NCT02566759|OG004|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
11252352|NCT02566759|OG005|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
11252353|NCT02566759|OG006|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
11252354|NCT02566759|OG007|Outcome|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
11252355|NCT02566759|OG008|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252356|NCT02566759|OG009|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252357|NCT02566759|OG010|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252358|NCT02566759|OG011|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252359|NCT02566759|OG012|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
11252360|NCT02566759|OG013|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252361|NCT02566759|OG014|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252362|NCT02566759|OG015|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
11252363|NCT02566759|OG016|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252364|NCT02566759|OG000|Outcome|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
11252365|NCT02566759|OG001|Outcome|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
11252366|NCT02566759|OG002|Outcome|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
11252367|NCT02566759|OG003|Outcome|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
11252368|NCT02566759|OG004|Outcome|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
11252369|NCT02566759|OG005|Outcome|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
11252370|NCT02566759|OG006|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252371|NCT02566759|OG007|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252372|NCT02566759|OG008|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252373|NCT02566759|OG009|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252374|NCT02566759|OG010|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252375|NCT02566759|OG011|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
11252376|NCT02566759|OG012|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252377|NCT02566759|OG000|Outcome|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252378|NCT02566759|OG001|Outcome|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252379|NCT02566759|OG002|Outcome|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252380|NCT02566759|OG003|Outcome|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252381|NCT02566759|OG004|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252382|NCT02566759|OG010|Outcome|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
11252383|NCT02566759|OG011|Outcome|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252384|NCT02566759|OG012|Outcome|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252385|NCT02566759|OG013|Outcome|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
11252386|NCT02566759|OG014|Outcome|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252387|NCT02566759|EG000|Reported Event|Part 1: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1.
11252388|NCT02566759|EG001|Reported Event|Part 1: TAK-831 10 mg|TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
11252389|NCT02566759|EG002|Reported Event|Part 1: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1.
11252390|NCT02566759|EG003|Reported Event|Part 1: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1.
11252391|NCT02566759|EG004|Reported Event|Part 1: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1.
11252392|NCT02566759|EG005|Reported Event|Part 1: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1.
11252393|NCT02566759|EG006|Reported Event|Part 1: TAK-831 750 mg|TAK-831 750 mg, suspension, orally, once on Day 1.
11252394|NCT02566759|EG007|Reported Event|Part 2: Placebo Pooled|TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
11252395|NCT02566759|EG008|Reported Event|Part 2: TAK-831 30 mg|TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
11252396|NCT02566759|EG009|Reported Event|Part 2: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
11252397|NCT02566759|EG010|Reported Event|Part 2: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
11252398|NCT02566759|EG011|Reported Event|Part 2: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
11252399|NCT02566759|EG012|Reported Event|Part 3: Placebo|TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
11252400|NCT02566759|EG013|Reported Event|Part 3: TAK-831 400 mg|TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
11252401|NCT02566759|EG014|Reported Event|Part 4: TAK-831 100 mg Tablet Fasted|TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252402|NCT02566759|EG015|Reported Event|Part 4: TAK-831 100 mg Tablet Fed|TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
11252403|NCT02566759|EG016|Reported Event|Part 4: TAK-831 100 mg Suspension Fasted|TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
11252404|NCT02566785|BG000|Baseline|Intervention Group|"Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252405|NCT02566785|BG001|Baseline|Wait List Control Group|"The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252406|NCT02566785|BG002|Baseline|Total|Total of all reporting groups
11252407|NCT02566785|FG000|Participant Flow|Intervention Group|"Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252408|NCT02566785|FG001|Participant Flow|Wait List Control Group|"The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252409|NCT02566785|OG000|Outcome|Intervention Group|"Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252410|NCT02566785|OG001|Outcome|Wait List Control Group|"The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252411|NCT02566785|EG000|Reported Event|Intervention Group|"Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252412|NCT02566785|EG001|Reported Event|Wait List Control Group|"The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.~Balance Intervention: The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance."
11252413|NCT02566889|BG000|Baseline|Reference Group|Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.
11252414|NCT02566889|BG001|Baseline|Dose Escalation Group|Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
11252415|NCT02566889|BG002|Baseline|Total|Total of all reporting groups
11252416|NCT02566889|FG000|Participant Flow|Reference Group|Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.
11252417|NCT02566889|FG001|Participant Flow|Dose Escalation Group|Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
11252418|NCT02566889|OG000|Outcome|Dose Escalation Group|Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
11341866|NCT03691779|OG000|Outcome|Part A: ELX/TEZ/IVA|Participants in part A received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h in the treatment period for 15 days.
11341867|NCT03691779|EG000|Reported Event|Part A: ELX/TEZ/IVA|Participants in Part A received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h in the treatment period for 15 days.
11252419|NCT02566889|EG000|Reported Event|Reference Group|Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.
11252420|NCT02566889|EG001|Reported Event|Dose Escalation Group|Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
11252421|NCT02566902|BG000|Baseline|T-piece Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental T-piece Nebulizer (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252422|NCT02566902|BG001|Baseline|Breath-Enhanced Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental Breath-Enhanced Nebulizer (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252423|NCT02566902|BG002|Baseline|Total|Total of all reporting groups
11252424|NCT02566902|FG000|Participant Flow|T-piece Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental T-piece Nebulizer (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252425|NCT02566902|FG001|Participant Flow|Breath-Enhanced Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental Breath-Enhanced Nebulizer (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252426|NCT02566902|OG000|Outcome|T-piece Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental T-piece Nebulizer (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252427|NCT02566902|OG001|Outcome|Breath-Enhanced Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental Breath-Enhanced Nebulizer (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11335681|NCT03554746|BG000|Baseline|GC Group|"It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks.~GC group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times~1st to 2nd: clam ex. without resistance single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th:~a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th: maintain 5th ex. lunge ex. without hip internal rotation"
11252428|NCT02566902|EG000|Reported Event|T-piece Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental T-piece Nebulizer (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252429|NCT02566902|EG001|Reported Event|Breath-Enhanced Nebulizer|"Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental Breath-Enhanced Nebulizer (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.~Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)~Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.~Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.~Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer."
11252430|NCT02566993|BG000|Baseline|Lurbinectedin/Doxorubicin|"Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.~The combination was to be administered for up to a maximum of ten cycles."
11252431|NCT02566993|BG001|Baseline|Topotecan or Cyclophosphamide/Doxorubicin/Vincristine|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:~1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.~1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.~0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.~or~CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:~Cyclophosphamide: 1000 mg/m2,~Doxorubicin: 45.0 mg/m2,~Vincristine: 2.0 mg flat dose. The triple combination was to be administered for up to a maximum of ten cycles"
11252432|NCT02566993|BG002|Baseline|Total|Total of all reporting groups
11252433|NCT02566993|FG000|Participant Flow|Lurbinectedin/Doxorubicin|"Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.~The combination was to be administered for up to a maximum of ten cycles."
11252434|NCT02566993|FG001|Participant Flow|Topotecan or Cyclophosphamide/Doxorubicin/Vincristine|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and Cyclophosphamide, Doxorubicin and Vincristine (CAV), until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:~1.50 mg/m2 daily, for patients with calculated Creatinine Clearance (CrCL) ≥60 mL/min.~1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.~0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.~or~CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:~Cyclophosphamide: 1000 mg/m2,~Doxorubicin: 45.0 mg/m2,~Vincristine: 2.0 mg flat dose. The triple combination was to be administered for up to a maximum of ten cycles"
11252435|NCT02566993|OG000|Outcome|Lurbinectedin/Doxorubicin|"Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.~The combination was to be administered for up to a maximum of ten cycles."
11335682|NCT03554746|BG001|Baseline|CG Group|"IIt involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.~CG group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps"
11335683|NCT03554746|BG002|Baseline|Total|Total of all reporting groups
11337360|NCT03582943|FG001|Participant Flow|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11252436|NCT02566993|OG001|Outcome|Topotecan or Cyclophosphamide/Doxorubicin/Vincristine|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:~1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.~1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.~0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.~or~CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:~Cyclophosphamide: 1000 mg/m2,~Doxorubicin: 45.0 mg/m2,~Vincristine: 2.0 mg flat dose (FD). The triple combination was to be administered for up to a maximum of ten cycles"
11252437|NCT02566993|OG001|Outcome|Topotecan or Cyclophosphamide/Doxorubicin/Vincristine|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:~1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.~1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.~0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.~or~CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:~Cyclophosphamide: 1000 mg/m2,~Doxorubicin: 45.0 mg/m2,~Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"
11252438|NCT02566993|EG000|Reported Event|Lurbinectedin/Doxorubicin|"Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL.~The combination was to be administered for up to a maximum of ten cycles."
11252439|NCT02566993|EG001|Reported Event|Topotecan|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:~1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.~1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.~0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min."
11252440|NCT02566993|EG002|Reported Event|Cyclophosphamide/Doxorubicin/Vincristine|"If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.~CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:~Cyclophosphamide: 1000 mg/m2,~Doxorubicin: 45.0 mg/m2,~Vincristine: 2.0 mg FD. The triple combination was to be administered for up to a maximum of ten cycles"
11252441|NCT02567188|BG000|Baseline|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
11252442|NCT02567188|FG000|Participant Flow|Chronic Kidney Disease (CKD) Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
11252443|NCT02567188|OG000|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
11252444|NCT02567188|OG000|Outcome|Cohort of CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
11252445|NCT02567188|EG000|Reported Event|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
11252446|NCT02567227|BG000|Baseline|Cognitive Remediation|"An individualized computerized cognitive remediation program.~Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."
11252447|NCT02567227|BG001|Baseline|Active Control|"Individualized computer based exposure and interactive health education classes.~Active Control: Computer, multimedia and group based health education programs."
11252448|NCT02567227|BG002|Baseline|Total|Total of all reporting groups
11252449|NCT02567227|FG000|Participant Flow|Cognitive Remediation|"An individualized computerized cognitive remediation program.~Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."
11252450|NCT02567227|FG001|Participant Flow|Active Control|"Individualized computer based exposure and interactive health education classes.~Active Control: Computer, multimedia and group based health education programs."
11252451|NCT02567227|OG000|Outcome|Cognitive Remediation|"An individualized computerized cognitive remediation program.~Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."
11252452|NCT02567227|OG001|Outcome|Active Control|"Individualized computer based exposure and interactive health education classes.~Active Control: Computer, multimedia and group based health education programs."
11252453|NCT02567227|EG000|Reported Event|Cognitive Remediation|"An individualized computerized cognitive remediation program.~Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."
11252454|NCT02567227|EG001|Reported Event|Active Control|"Individualized computer based exposure and interactive health education classes.~Active Control: Computer, multimedia and group based health education programs."
11252455|NCT02567266|BG000|Baseline|Unified Protocol for Adolescents (UP-A)|"Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.~The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention."
11252456|NCT02567266|BG001|Baseline|Treatment as Usual Plus (TAU+)|"Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual~Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging critical items that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived alerts when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252457|NCT02567266|BG002|Baseline|Treatment as Usual (TAU)|"Participants will receive Treatment as Usual provided at the study clinics.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252458|NCT02567266|BG003|Baseline|Total|Total of all reporting groups
11252459|NCT02567266|FG000|Participant Flow|Unified Protocol for Adolescents (UP-A)|"Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.~The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention."
11252460|NCT02567266|FG001|Participant Flow|Treatment as Usual Plus (TAU+)|"Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual~Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging critical items that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived alerts when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252461|NCT02567266|FG002|Participant Flow|Treatment as Usual (TAU)|"Participants will receive Treatment as Usual provided at the study clinics.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252462|NCT02567266|OG000|Outcome|Unified Protocol for Adolescents (UP-A)|"Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.~The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention."
11341868|NCT03691779|EG001|Reported Event|Part B: ELX/TEZ/IVA|Participants in Part B weighing <30 kg at Day 1 received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h and participants weighing >=30 kg at Day 1 received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
11341869|NCT03691831|BG000|Baseline|Active|"Topical solution, hydrogen peroxide 45%~A-101: hydrogen peroxide 45% topical solution"
11252463|NCT02567266|OG001|Outcome|Treatment as Usual Plus (TAU+)|"Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual~Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging critical items that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived alerts when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252464|NCT02567266|OG002|Outcome|Treatment as Usual (TAU)|"Participants will receive Treatment as Usual provided at the study clinics.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252465|NCT02567266|EG000|Reported Event|Unified Protocol for Adolescents (UP-A)|"Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.~The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention."
11252466|NCT02567266|EG001|Reported Event|Treatment as Usual Plus (TAU+)|"Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual~Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging critical items that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived alerts when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252467|NCT02567266|EG002|Reported Event|Treatment as Usual (TAU)|"Participants will receive Treatment as Usual provided at the study clinics.~Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders."
11252468|NCT02567552|BG000|Baseline|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
11252469|NCT02567552|BG001|Baseline|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
11252470|NCT02567552|BG002|Baseline|Total|Total of all reporting groups
11252471|NCT02567552|FG000|Participant Flow|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
11252472|NCT02567552|FG001|Participant Flow|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
11252473|NCT02567552|OG000|Outcome|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
11252474|NCT02567552|OG001|Outcome|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
11252475|NCT02567552|EG000|Reported Event|Prolutex|"Subcutaneous progesterone~Subcutaneous progesterone: subcutaneous progesterone 25 mg/day"
11252476|NCT02567552|EG001|Reported Event|Prontogest|"Intramuscular progesterone~Intramuscular progesterone: intramuscular progesterone 50 mg/day"
11252477|NCT02567656|BG000|Baseline|Dose escalation_Cohort 1_200 mg|RP6530 administered 200 mg orally twice a day.
11252478|NCT02567656|BG001|Baseline|Dose escalation_Cohort 2_400 mg|RP6530 administered 400 mg orally twice a day.
11252479|NCT02567656|BG002|Baseline|Dose escalation_Cohort 3_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252480|NCT02567656|BG003|Baseline|Dose escalation_Cohort 4_800 mg (Fed)|RP6530 administered 800 mg orally twice a day under fed condition
11252481|NCT02567656|BG004|Baseline|Dose expansion_PTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252482|NCT02567656|BG005|Baseline|Dose expansion_CTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252483|NCT02567656|BG006|Baseline|Total|Total of all reporting groups
11252484|NCT02567656|FG000|Participant Flow|Dose escalation_Cohort 1_200 mg|RP6530 administered 200 mg orally twice a day.
11252485|NCT02567656|FG001|Participant Flow|Dose escalation_Cohort 2_400 mg|RP6530 administered 400 mg orally twice a day.
11252486|NCT02567656|FG002|Participant Flow|Dose escalation_Cohort 3_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252487|NCT02567656|FG003|Participant Flow|Dose escalation_Cohort 4_800 mg (Fed)|RP6530 administered 800 mg orally twice a day under fed condition
11252488|NCT02567656|FG004|Participant Flow|Dose expansion_PTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252489|NCT02567656|FG005|Participant Flow|Dose expansion_CTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252490|NCT02567656|OG000|Outcome|Dose escalation_Cohort 1_200 mg|RP6530 administered 200 mg orally twice a day.
11252491|NCT02567656|OG001|Outcome|Dose escalation_Cohort 2_400 mg|RP6530 administered 400 mg orally twice a day.
11252492|NCT02567656|OG002|Outcome|Dose escalation_Cohort 3_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252493|NCT02567656|OG003|Outcome|Dose escalation_Cohort 4_800 mg (Fed)|RP6530 administered 800 mg orally twice a day under fed condition
11252494|NCT02567656|OG004|Outcome|Dose expansion_PTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252495|NCT02567656|OG005|Outcome|Dose expansion_CTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252496|NCT02567656|EG000|Reported Event|Dose escalation_Cohort 1_200 mg|RP6530 administered 200 mg orally twice a day.
11252497|NCT02567656|EG001|Reported Event|Dose escalation_Cohort 2_400 mg|RP6530 administered 400 mg orally twice a day.
11252498|NCT02567656|EG002|Reported Event|Dose escalation_Cohort 3_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252499|NCT02567656|EG003|Reported Event|Dose escalation_Cohort 4_800 mg (Fed)|RP6530 administered 800 mg orally twice a day under fed condition
11252500|NCT02567656|EG004|Reported Event|Dose expansion_PTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252501|NCT02567656|EG005|Reported Event|Dose expansion_CTCL_800 mg (Fasting)|RP6530 administered 800 mg orally twice a day under fasting condition
11252502|NCT02567708|BG000|Baseline|All Participants|In Sequence 1 participants received placebo drug once daily via dry powder inhaler for 28 days during Treatment Period 1. After a washout period of 4 weeks, participants received GSK2269557 1000 micrograms (µg) drug once daily via dry powder inhaler for 28 days during Treatment Period 2. In addition, salbutamol was provided to participants to use on an as-needed basis for relief of asthma symptoms. In Sequence 2 participants received GSK2269557 1000 micrograms (µg) drug once daily via dry powder inhaler for 28 days during Treatment Period 1. After a washout period of 4 weeks, participants received placebo drug once daily via dry powder inhaler for 28 days during Treatment Period 2. In addition, salbutamol was provided to participants to use on an as-needed basis for relief of asthma symptoms.
11252503|NCT02567708|FG000|Participant Flow|Placebo, Then GSK2269557|Participants received placebo drug once daily via dry powder inhaler for 28 days during Treatment Period 1. After a washout period of 4 weeks, participants received GSK2269557 1000 micrograms (µg) drug once daily via dry powder inhaler for 28 days during Treatment Period 2. In addition, salbutamol was provided to participants to use on an as-needed basis for relief of asthma symptoms.
11252504|NCT02567708|FG001|Participant Flow|GSK2269557, Then Placebo|Participants received GSK2269557 1000 µg drug once daily via dry powder inhaler for the 28 days during Treatment Period 1. After a washout period of 4 weeks, participants received placebo drug once daily via dry powder inhaler for 28 days during Treatment Period 2. In addition, salbutamol was provided to participants to use on an as-needed basis for relief of asthma symptoms.
11252505|NCT02567708|OG000|Outcome|Placebo|Participants who received matching placebo once daily via dry powder inhaler for 28 days in either treatment period 1 or 2.
11252506|NCT02567708|OG001|Outcome|GSK2269557 1000 µg|Participants who received GSK2269557 1000 µg once daily via dry powder inhaler for 28 days in either treatment period 1 or 2.
11252507|NCT02567708|OG000|Outcome|GSK2269557 1000 µg|Participants who received GSK2269557 1000 µg once daily via dry powder inhaler for 28 days in either treatment period 1 or 2.
11252508|NCT02567708|EG000|Reported Event|Placebo|Participants who received matching placebo once daily via dry powder inhaler for 28 days in either treatment period 1 or 2.
11252509|NCT02567708|EG001|Reported Event|GSK2269557 1000 µg|Participants who received GSK2269557 1000 µg once daily via dry powder inhaler for 28 days in either treatment period 1 or 2.
11252510|NCT02567968|BG000|Baseline|All Study Participants|Participants who were randomized to either receive Caffeine then Placebo or Placebo then Caffeine
11252511|NCT02567968|FG000|Participant Flow|Caffeine, Then Placebo|Participants first received Caffeine. After a washout period of 2 weeks, they then received Placebo.
11252512|NCT02567968|FG001|Participant Flow|Placebo, Then Caffeine|Participants first received Placebo, and after 2-week washout period, then received Caffeine
11252513|NCT02567968|OG000|Outcome|Placebo|Placebo Control: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
11252514|NCT02567968|OG001|Outcome|Caffeine|Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
11252515|NCT02567968|EG000|Reported Event|Placebo|Placebo Control: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
11252516|NCT02567968|EG001|Reported Event|Caffeine|Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
11252517|NCT02568046|BG000|Baseline|Dose Level 1: Sym004 12 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252518|NCT02568046|BG001|Baseline|Dose Level -1: Sym004 9 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252519|NCT02568046|BG002|Baseline|Total|Total of all reporting groups
11252520|NCT02568046|FG000|Participant Flow|Dose Level 1: Sym004 12 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11341870|NCT03691831|BG001|Baseline|Vehicle|"Topical solution, isopropyl alcohol and water~Vehicle: Vehicle solution containing isopropyl alcohol and water"
11341871|NCT03691831|BG002|Baseline|Total|Total of all reporting groups
11341872|NCT03691831|FG000|Participant Flow|Active|"Topical solution, hydrogen peroxide 45%~A-101: hydrogen peroxide 45% topical solution"
11341873|NCT03691831|FG001|Participant Flow|Vehicle|"Topical solution, isopropyl alcohol and water~Vehicle: Vehicle solution containing isopropyl alcohol and water"
11341874|NCT03691831|OG000|Outcome|Active|"Topical solution, hydrogen peroxide 45%~A-101: hydrogen peroxide 45% topical solution"
11252521|NCT02568046|FG001|Participant Flow|Dose Level -1: Sym004 9 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252522|NCT02568046|OG000|Outcome|Dose Level 1: Sym004 12 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252523|NCT02568046|OG001|Outcome|Dose Level -1: Sym004 9 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252524|NCT02568046|EG000|Reported Event|Dose Level 1: Sym004 12 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252525|NCT02568046|EG001|Reported Event|Dose Level -1: Sym004 9 mg/kg + FOLFIRI|"Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).~The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours)."
11252526|NCT02568072|BG000|Baseline|Study Group|120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
11252527|NCT02568072|FG000|Participant Flow|Study Group|120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
11252528|NCT02568072|OG000|Outcome|Baseline|Study participants with places in the 2016 London Marathon assessed prior to training
11252529|NCT02568072|OG001|Outcome|7 Months|Study participants evaluated after completing the 2016 London Marathon
11252530|NCT02568072|EG000|Reported Event|Study Group|120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
11252531|NCT02568254|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
11252532|NCT02568254|FG000|Participant Flow|Etafilcon A/ Nelfilcon A/ Nesofilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third.
11252533|NCT02568254|FG001|Participant Flow|Etafilcon A/ Nesofilcon A/ Nelfilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third.
11252534|NCT02568254|FG002|Participant Flow|Nelfilcon A/ Nesofilcon A/ Etafilcon A|All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third.
11252535|NCT02568254|FG003|Participant Flow|Nelfilcon A/ Etafilcon A/ Nesofilcon A|All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third.
11252536|NCT02568254|FG004|Participant Flow|Nesolfilcon A/ Etafilcon A/ Nelfilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third.
11252537|NCT02568254|FG005|Participant Flow|Nesofilcon A/ Nelfilcon A/Etafilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third.
11252538|NCT02568254|OG000|Outcome|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
11252539|NCT02568254|OG001|Outcome|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
11252540|NCT02568254|OG002|Outcome|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
11252541|NCT02568254|EG000|Reported Event|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
11252542|NCT02568254|EG001|Reported Event|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
11252543|NCT02568254|EG002|Reported Event|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
11252544|NCT02568345|BG000|Baseline|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
11252545|NCT02568345|FG000|Participant Flow|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
11252546|NCT02568345|OG000|Outcome|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
11252547|NCT02568345|EG000|Reported Event|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
11252548|NCT02568384|BG000|Baseline|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
11252549|NCT02568384|FG000|Participant Flow|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
11252550|NCT02568384|OG000|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
11252551|NCT02568384|EG000|Reported Event|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:~40 to 70% of subjects will have type 1 diabetes~Not more than 30% of subjects will use an insulin pump~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
11252552|NCT02568397|BG000|Baseline|Overall|Overall study population
11252553|NCT02568397|FG000|Participant Flow|Dabigatran Etexilate|Single dose of dabigatran etexilate administered orally on Day 1.
11252554|NCT02568397|FG001|Participant Flow|LY3314814 + Dabigatran Etexilate|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the LY3314814 dosing
11252555|NCT02568397|OG000|Outcome|Dabigatran Etexilate|Single dose of 150mg dabigatran etexilate administered orally on Day 1.
11252556|NCT02568397|OG001|Outcome|LY3314814 and Dabigatran Etexilate Day 16|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 16.
11252557|NCT02568397|OG002|Outcome|LY3314814 and Dabigatran Etexilate Day 20|Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
11252558|NCT02568397|OG000|Outcome|LY3314814 (AZD3293)|50 mg LY3314814 administered orally alone on Day 15.
11252559|NCT02568397|OG000|Outcome|LY3314814 (AZD3293)|50 mg LY3314814 administered orally alone on Day 15
11252560|NCT02568397|OG001|Outcome|LY3314814 and Dabigatran Etexilate Day 16|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16.
11252561|NCT02568397|OG002|Outcome|LY3314814 and Dabigatran Etexilate Day 20|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 20.
11252562|NCT02568397|OG000|Outcome|Dabigatran Extexilate Day 1|Single dose of 150 mg dabigatran etexilate administered orally on Day 1
11252563|NCT02568397|OG000|Outcome|Dabigatran Extexilate Day 1|Single dose of 150mg dabigatran etexilate administered orally on Day 1.
11252564|NCT02568397|EG000|Reported Event|Dabigatran Etexilate|Single dose of 150mg dabigatran etexilate administered orally.
11252565|NCT02568397|EG001|Reported Event|LY3314814 (AZD3293)|50 mg LY3314814 administered orally alone on Day 15
11252566|NCT02568397|EG002|Reported Event|LY3314814 and Dabigatran Etexilate Day 16|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16.
11252567|NCT02568397|EG003|Reported Event|LY3314814 and Dabigatran Etexilate Day 20|Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 20.
11252568|NCT02568475|BG000|Baseline|Decision Aid|"Provision of Go to the Hospital or Stay Here?~Provision of Go to the Hospital or Stay Here?: Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days."
11252569|NCT02568475|BG001|Baseline|No Decision Aid|Does not receive the decision aid.
11252570|NCT02568475|BG002|Baseline|Total|Total of all reporting groups
11341875|NCT03691831|OG001|Outcome|Vehicle|"Topical solution, isopropyl alcohol and water~Vehicle: Vehicle solution containing isopropyl alcohol and water"
11341876|NCT03691831|EG000|Reported Event|Active|"Topical solution, hydrogen peroxide 45%~A-101: hydrogen peroxide 45% topical solution"
11341877|NCT03691831|EG001|Reported Event|Vehicle|"Topical solution, isopropyl alcohol and water~Vehicle: Vehicle solution containing isopropyl alcohol and water"
11252571|NCT02568475|FG000|Participant Flow|Decision Aid|"Provision of Go to the Hospital or Stay Here?~Provision of Go to the Hospital or Stay Here?: Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days."
11252572|NCT02568475|FG001|Participant Flow|No Decision Aid|Does not receive the decision aid.
11252573|NCT02568475|OG000|Outcome|Decision Aid|"Received and Discussed the Decision Aid~Provision of Go to the Hospital or Stay Here?: Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days."
11252574|NCT02568475|OG001|Outcome|No Decision Aid|Does not receive the decision aid.
11252575|NCT02568475|EG000|Reported Event|Decision Aid|"Received and Discussed the Decision Aid~Provision of Go to the Hospital or Stay Here?: Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days."
11252576|NCT02568475|EG001|Reported Event|No Decision Aid|Does not receive the decision aid.
11252577|NCT02568644|BG000|Baseline|Extract of Ginger|"People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).~Extract of ginger: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).~Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252578|NCT02568644|BG001|Baseline|Cellulose|"People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).~Cellulose: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).~Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252579|NCT02568644|BG002|Baseline|Total|Total of all reporting groups
11252580|NCT02568644|FG000|Participant Flow|Extract of Ginger|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).~Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252581|NCT02568644|FG001|Participant Flow|Cellulose|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).~Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252582|NCT02568644|OG000|Outcome|Extract of Ginger|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).~Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252583|NCT02568644|OG001|Outcome|Cellulose|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).~Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252584|NCT02568644|OG000|Outcome|Extract of Ginger|"People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).~Extract of ginger: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).~Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11341878|NCT03691844|BG000|Baseline|AMZ001 BID|"on the target knee~AMZ001 gel twice daily.~BID: twice a day/twice daily"
11341879|NCT03691844|BG001|Baseline|AMZ001 + Placebo QD|"on the target knee~AMZ001 gel once daily, Placebo gel once daily.~QD: Every day/daily"
11341880|NCT03691844|BG002|Baseline|Placebo BID|"on the target knee~Placebo gel twice daily.~BID: 2 times a day/ twice a day"
11215686|NCT02300727|EG004|Reported Event|Curcumin-MTD 2g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 2g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 2g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215687|NCT02300727|EG005|Reported Event|Curcumin-MTD 3g Dose|"Curcumin (BCM-95) administered by ingested mouth rinse. A total of 3-6 subjects will be in this arm to determine maximum tolerated dose (MTD).~There will be 3 participants at a dose of 3g curcumin per rinse, three times daily for 4-6 weeks. (additional 3 subjects if a dose-limiting toxicity occurs)~Curcumin-MTD: 3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD)."
11215688|NCT02300987|BG000|Baseline|LEE011|600 mg daily dosing days 1-21 of a 28 day cycle
11215689|NCT02300987|BG001|Baseline|Placebo Arm|600 mg daily dosing days 1-21 of a 28 day cycle
11215690|NCT02300987|BG002|Baseline|Total|Total of all reporting groups
11215691|NCT02300987|FG000|Participant Flow|LEE011|600 mg daily dosing days 1-21 of a 28 day cycle
11215692|NCT02300987|FG001|Participant Flow|Placebo Arm|600 mg daily dosing days 1-21 of a 28 day cycle
11215693|NCT02300987|OG000|Outcome|LEE011|600 mg daily dosing days 1-21 of a 28 day cycle
11215694|NCT02300987|OG001|Outcome|Placebo Arm|600 mg daily dosing days 1-21 of a 28 day cycle
11215695|NCT02300987|EG000|Reported Event|LEE011|600 mg daily dosing days 1-21 of a 28 day cycle
11215696|NCT02300987|EG001|Reported Event|Placebo|Placebo
11215697|NCT02300987|EG002|Reported Event|All Patients|All patients
11215698|NCT02301039|BG000|Baseline|Soft Tissue Sarcoma|"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215699|NCT02301039|BG001|Baseline|Bone Sarcoma|"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215700|NCT02301039|BG002|Baseline|Expansion|Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma
11215701|NCT02301039|BG003|Baseline|Total|Total of all reporting groups
11215702|NCT02301039|FG000|Participant Flow|Soft Tissue Sarcoma|"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215703|NCT02301039|FG001|Participant Flow|Bone Sarcoma|"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215704|NCT02301039|FG002|Participant Flow|Expansion Cohort|Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
11215705|NCT02301039|OG000|Outcome|Soft Tissue Sarcoma|"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215706|NCT02301039|OG001|Outcome|Bone Sarcoma|"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215707|NCT02301039|OG002|Outcome|Expansion Cohort|Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
11215708|NCT02301039|EG000|Reported Event|Soft Tissue Sarcoma|"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215709|NCT02301039|EG001|Reported Event|Bone Sarcoma|"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks~Pembrolizumab"
11215710|NCT02301039|EG002|Reported Event|Expansion|Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks
11215711|NCT02301143|BG000|Baseline|Nab-Paclitaxel Plus Gemcitabine|In the Induction period, nab-paclitaxel 125 mg/m^2 intravenous (IV) infusion was administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period: - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
11215712|NCT02301143|FG000|Participant Flow|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period.
11252585|NCT02568644|OG001|Outcome|Cellulose|"People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).~Cellulose: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).~Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252586|NCT02568644|EG000|Reported Event|Extract of Ginger|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois) and intravenous ketoprofen (100mg).~Extract of ginger: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerois).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252587|NCT02568644|EG001|Reported Event|Cellulose|"30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).~Cellulose: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).~Intravenous ketoprofen: 30 people (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg)."
11252588|NCT02568683|BG000|Baseline|ENTO 200 mg|Participants received ENTO 200 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 24 weeks.
11252589|NCT02568683|BG001|Baseline|ENTO 400 mg|Participants received ENTO 400 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 8 weeks.
11252590|NCT02568683|BG002|Baseline|Total|Total of all reporting groups
11252591|NCT02568683|FG000|Participant Flow|ENTO 200 mg|Participants received entospletinib (ENTO) 200 mg tablet twice daily + vincristine (VCR) 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 24 weeks.
11252592|NCT02568683|FG001|Participant Flow|ENTO 400 mg|Participants received ENTO 400 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 8 weeks.
11252593|NCT02568683|OG000|Outcome|ENTO 200 mg|Participants received ENTO 200 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 24 weeks.
11252594|NCT02568683|OG001|Outcome|ENTO 400 mg|Participants received ENTO 400 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 8 weeks.
11252595|NCT02568683|EG000|Reported Event|ENTO 200 mg|Participants received ENTO 200 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 24 weeks.
11252596|NCT02568683|EG001|Reported Event|ENTO 400 mg|Participants received ENTO 400 mg tablet twice daily + VCR 1.0 mg/m^2 administered via intravenous infusion every 14 days; up to 8 weeks.
11252597|NCT02568852|BG000|Baseline|Group 1|Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
11252598|NCT02568852|BG001|Baseline|Group 2|Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
11252599|NCT02568852|BG002|Baseline|Total|Total of all reporting groups
11252600|NCT02568852|FG000|Participant Flow|Group 1|Laparoscopic cholecystectomy under general anaesthesia
11252601|NCT02568852|FG001|Participant Flow|Group 2|Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
11252602|NCT02568852|OG000|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
11252603|NCT02568852|OG001|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
11252604|NCT02568852|EG000|Reported Event|Group 1|Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)
11252605|NCT02568852|EG001|Reported Event|Group 2|Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
11252606|NCT02569086|BG000|Baseline|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
11252607|NCT02569086|FG000|Participant Flow|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
11252608|NCT02569086|OG000|Outcome|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
11252609|NCT02569086|EG000|Reported Event|Piperacillin Pharmacokinetics|Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
11252610|NCT02569112|BG000|Baseline|Cryolipolysis Treatment & Cryolipolysis With Legacy|Each patient is their own control. Both flanks will be treated with cryolypolysis. The flank will be divided into two equal treatment areas where one side will receive multipolar radiofrequency with varipulse technology treatment and the other side will not.
11252611|NCT02569112|FG000|Participant Flow|Cyrolipolysis|Each side of the subject received a cryolipolysis treatment.
11252612|NCT02569112|FG001|Participant Flow|Cryolipolysis, Multipolar RF With Varipulse Technology|One side of the body received cryolipolysis plus multipolar radiofrequency with varipulse technology
11252613|NCT02569112|OG000|Outcome|Cryolipolysis Treatment & Cryolipolysis With Legacy|Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment
11252614|NCT02569112|EG000|Reported Event|ONE DEVICE USED - CoolSculpt Flank Side|Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment
11341881|NCT03691844|BG003|Baseline|Voltaren 1% QID|"on the target knee~Voltaren gel 1% applied 4 times a day"
11341882|NCT03691844|BG004|Baseline|Total|Total of all reporting groups
11341883|NCT03691844|FG000|Participant Flow|AMZ001 BID|"on the target knee~AMZ001 gel twice daily.~BID: Twice a day"
11252615|NCT02569112|EG001|Reported Event|TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side|Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment while the other side will have both a cryolypolysis treatment and an RF, PEMF and Varipulse (Venus Legacy) treatment
11252616|NCT02569398|BG000|Baseline|Placebo|Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
11252617|NCT02569398|BG001|Baseline|JNJ-54861911 (5 mg)|Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
11252618|NCT02569398|BG002|Baseline|JNJ-54861911 (25 mg)|Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
11252619|NCT02569398|BG003|Baseline|Total|Total of all reporting groups
11252620|NCT02569398|FG000|Participant Flow|Placebo|Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
11252621|NCT02569398|FG001|Participant Flow|JNJ-54861911 (5 mg)|Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
11252622|NCT02569398|FG002|Participant Flow|JNJ-54861911 (25 mg)|Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
11252623|NCT02569398|OG000|Outcome|Placebo|Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
11252624|NCT02569398|OG001|Outcome|JNJ-54861911 (5 mg)|Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
11252625|NCT02569398|OG002|Outcome|JNJ-54861911 (25 mg)|Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
11252626|NCT02569398|EG000|Reported Event|Placebo|Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
11252627|NCT02569398|EG001|Reported Event|JNJ-54861911 (5 mg)|Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
11252628|NCT02569398|EG002|Reported Event|JNJ-54861911 (25 mg)|Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
11252629|NCT02569411|BG000|Baseline|No Incentive|Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
11252630|NCT02569411|BG001|Baseline|Incentive|"Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive.~Financial Incentive: money"
11252631|NCT02569411|BG002|Baseline|Total|Total of all reporting groups
11252632|NCT02569411|FG000|Participant Flow|No Incentive (Control)|Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.
11252633|NCT02569411|FG001|Participant Flow|Financial Incentive (Intervention)|Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
11252634|NCT02569411|OG000|Outcome|No Incentive (Control)|Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.
11252635|NCT02569411|OG001|Outcome|Financial Incentive (Intervention)|Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
11252636|NCT02569411|EG000|Reported Event|No Incentive (Control)|Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.
11252637|NCT02569411|EG001|Reported Event|Financial Incentive (Intervention)|Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
11252638|NCT02569437|BG000|Baseline|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
11252639|NCT02569437|BG001|Baseline|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
11252640|NCT02569437|BG002|Baseline|Total|Total of all reporting groups
11252641|NCT02569437|FG000|Participant Flow|Doxycycline|"Doxycycline plus oral methylprednisolone and nasal saline sprays~Doxycycline: Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20~methylprednisolone: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days~nasal saline spray: nasal saline sprays: 2 sprays each nostril three times a day~Flonase: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily)."
11252642|NCT02569437|FG001|Participant Flow|Sugar Pill|"placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.~methylprednisolone: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days~Flonase: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).~sugar pill: placebo pill to match doxycycline"
11252643|NCT02569437|OG000|Outcome|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
11252644|NCT02569437|OG001|Outcome|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
11252645|NCT02569437|EG000|Reported Event|Doxycycline|Doxycycline plus oral methylprednisolone and nasal saline sprays
11252646|NCT02569437|EG001|Reported Event|Sugar Pill|placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
11252647|NCT02569541|BG000|Baseline|CEM-102 (Sodium Fusidate)|"1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:~6 months of treatment; or~24 months of treatment (if continued on chronic suppressive therapy)~sodium fusidate"
11252648|NCT02569541|FG000|Participant Flow|CEM-102 (Sodium Fusidate)|"1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:~6 months of treatment; or~24 months of treatment (if continued on chronic suppressive therapy)~sodium fusidate"
11252649|NCT02569541|OG000|Outcome|CEM-102 (Sodium Fusidate)|"1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:~6 months of treatment; or~24 months of treatment (if continued on chronic suppressive therapy)~sodium fusidate"
11252650|NCT02569541|EG000|Reported Event|CEM-102 (Sodium Fusidate)|"1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:~6 months of treatment; or~24 months of treatment (if continued on chronic suppressive therapy)~sodium fusidate"
11252651|NCT02569632|BG000|Baseline|Open Label: MenB-FHbp|"Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)~Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals): All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule."
11252652|NCT02569632|FG000|Participant Flow|Open Label: MenB-FHbp|"Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)~Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals): All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule."
11252653|NCT02569632|OG000|Outcome|Open Label: MenB-FHbp|"Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)~Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals): All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule."
11252654|NCT02569632|EG000|Reported Event|Open Label: MenB-FHbp|"Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)~Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals): All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule."
11252655|NCT02569658|BG000|Baseline|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
11252656|NCT02569658|BG001|Baseline|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
11252657|NCT02569658|BG002|Baseline|Total|Total of all reporting groups
11252658|NCT02569658|FG000|Participant Flow|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
11252659|NCT02569658|FG001|Participant Flow|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
11252660|NCT02569658|OG000|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
11252661|NCT02569658|OG001|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
11252662|NCT02569658|EG000|Reported Event|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
11252663|NCT02569658|EG001|Reported Event|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
11252664|NCT02569710|BG000|Baseline|Cohort 1 (8 Weeks Genotype [GT1])|Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
11252665|NCT02569710|BG001|Baseline|Cohort 1b + Cohort 4 (8 Weeks GT1)|Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
11252666|NCT02569710|BG002|Baseline|Cohort 2 (8 Weeks GT1)|Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252667|NCT02569710|BG003|Baseline|Cohort 3 (6 Weeks GT1)|Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
11252668|NCT02569710|BG004|Baseline|Cohort 4 (12 Weeks GT1)|Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
11252669|NCT02569710|BG005|Baseline|Cohort 5a (8 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252670|NCT02569710|BG006|Baseline|Cohort 5b (12 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
11252671|NCT02569710|BG007|Baseline|Cohort 6,7,8 (8 Weeks GT1 F4)|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
11252672|NCT02569710|BG008|Baseline|Cohort 9 (12 Weeks GT1 F4)|Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252673|NCT02569710|BG009|Baseline|Cohort 11 (12 Weeks GT2 F4)|Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252674|NCT02569710|BG010|Baseline|Total|Total of all reporting groups
11252675|NCT02569710|FG000|Participant Flow|Cohort 1 (8 Weeks Genotype [GT1])|Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
11252676|NCT02569710|FG001|Participant Flow|Cohort 1b + Cohort 4 (8 Weeks GT1)|Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
11252677|NCT02569710|FG002|Participant Flow|Cohort 2 (8 Weeks GT1)|Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252678|NCT02569710|FG003|Participant Flow|Cohort 3 (6 Weeks GT1)|Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
11252679|NCT02569710|FG004|Participant Flow|Cohort 4 (12 Weeks GT1)|Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
11252680|NCT02569710|FG005|Participant Flow|Cohort 5a (8 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252681|NCT02569710|FG006|Participant Flow|Cohort 5b (12 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
11252682|NCT02569710|FG007|Participant Flow|Cohort 6,7,8 (8 Weeks GT1 F4)|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
11252683|NCT02569710|FG008|Participant Flow|Cohort 9 (12 Weeks GT1 F4)|Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252684|NCT02569710|FG009|Participant Flow|Cohort 11 (12 Weeks GT2 F4)|Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252685|NCT02569710|OG000|Outcome|Cohort 1 (8 Weeks Genotype [GT1])|Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
11252686|NCT02569710|OG001|Outcome|Cohort 1b + Cohort 4 (8 Weeks GT1)|Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
11252687|NCT02569710|OG002|Outcome|Cohort 2 (8 Weeks GT1)|Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252688|NCT02569710|OG003|Outcome|Cohort 3 (6 Weeks GT1)|Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
11252689|NCT02569710|OG004|Outcome|Cohort 4 (12 Weeks GT1)|Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
11252690|NCT02569710|OG005|Outcome|Cohort 5a (8 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252691|NCT02569710|OG006|Outcome|Cohort 5b (12 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
11252692|NCT02569710|OG007|Outcome|Cohort 6,7,8 (8 Weeks GT1 F4)|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
11252693|NCT02569710|OG008|Outcome|Cohort 9 (12 Weeks GT1 F4)|Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252694|NCT02569710|OG009|Outcome|Cohort 11 (12 Weeks GT2 F4)|Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252695|NCT02569710|OG000|Outcome|Cohort 1|Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
11252696|NCT02569710|OG001|Outcome|Cohort 1b + Cohort 4|Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
11252697|NCT02569710|OG002|Outcome|Cohort 2 + Cohort 3 + Cohort 5|Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
11252698|NCT02569710|OG003|Outcome|Cohort 6|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
10969887|NCT00908037|BG001|Baseline|Part 2 (Randomized Period) Cohort 1-Placebo|Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
11213625|NCT02287896|BG000|Baseline|IM Arm Roledumab|"Roledumab Open-label IM~Dosage and frequency of administration:~Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage"
11213626|NCT02287896|BG001|Baseline|IV Arm Roledumab|"Roledumab Open-label IV~Dosage and frequency of administration:~Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage."
11213627|NCT02287896|BG002|Baseline|Total|Total of all reporting groups
11213628|NCT02287896|FG000|Participant Flow|IM Arm Roledumab|"Roledumab Open-label IM~Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage"
11213629|NCT02287896|FG001|Participant Flow|IV Arm Roledumab|"Roledumab Open-label IV~Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage."
11213630|NCT02287896|OG000|Outcome|Population PK (PKS1)|Single dose of Roledumab 300 μg has been administered for ante- and postnatal periods.
11213631|NCT02287896|OG000|Outcome|IM Arm Roledumab|"Arm with RhD-negative pregnant women who were allocated to the IM route of administration of Roledumab.~- Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation."
11213632|NCT02287896|OG001|Outcome|IV Arm Roledumab|"Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab.~- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation."
11213633|NCT02287896|OG001|Outcome|IV Arm Roledumab|"Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab.~Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation."
11213634|NCT02287896|OG001|Outcome|IV Arm Roledumab|"Arm with RhD-negative women who were allocated to the IV route of administration of Roledumab.~- Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation"
11213635|NCT02287896|OG000|Outcome|IM Arm Roledumab|"Arm with RhD-negative pregnant women who were allocated to the IM route of administration of Roledumab.~Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation."
11213636|NCT02287896|OG001|Outcome|IV Arm Roledumab|"Arm with RhD-negative pregnant women who were allocated to the IV route of administration of Roledumab.~Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation."
11213637|NCT02287896|EG000|Reported Event|IM Arm Roledumab|"Arm with RhD-negative pregnant women who were allocated to the IM route of administration of LFB-R593~Dosage and frequency of administration:~Planned antenatal prophylaxis: A single dose of 300 µg IM of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IM anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IM postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage"
11215713|NCT02301143|FG001|Participant Flow|Investigator Choice|For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. Investigator Choice includes 3 options: 1. Continued on nab-Paclitaxel and gemcitabine 2. Chemoradiation 3. Surgical Intervention
11341884|NCT03691844|FG001|Participant Flow|AMZ001 + Placebo QD|"on the target knee~AMZ001 gel once daily, Placebo gel once daily.~QD: Every day/daily"
11252699|NCT02569710|OG004|Outcome|Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11|Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
11252700|NCT02569710|OG002|Outcome|Cohort 2 + Cohort 3 + Cohort 5|Cohort 2+3+5 (Participants without Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD
11252701|NCT02569710|OG003|Outcome|Cohort 6|Cohort 6 (Participants with Cirrhosis): received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
11252702|NCT02569710|OG001|Outcome|Cohort 2 + Cohort 3 + Cohort 5|Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
11252703|NCT02569710|OG002|Outcome|Cohort 6|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
11252704|NCT02569710|OG003|Outcome|Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11|Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
11252705|NCT02569710|OG003|Outcome|Cohort 3 (6 Weeks GT1)|Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
11252706|NCT02569710|EG000|Reported Event|Cohort 1 (8 Weeks Genotype [GT1])|Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
11252707|NCT02569710|EG001|Reported Event|Cohort 1b + Cohort 4 (8 Weeks GT1)|Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
11252708|NCT02569710|EG002|Reported Event|Cohort 2 (8 Weeks GT1)|Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252709|NCT02569710|EG003|Reported Event|Cohort 3 (6 Weeks GT1)|Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
11252710|NCT02569710|EG004|Reported Event|Cohort 4 (12 Weeks GT1)|Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
11252711|NCT02569710|EG005|Reported Event|Cohort 5a (8 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
11252712|NCT02569710|EG006|Reported Event|Cohort 5b (12 Weeks GT3)|Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
11252713|NCT02569710|EG007|Reported Event|Cohort 6,7,8 (8 Weeks GT1 F4)|Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
11252714|NCT02569710|EG008|Reported Event|Cohort 9 (12 Weeks GT1 F4)|Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252715|NCT02569710|EG009|Reported Event|Cohort 11 (12 Weeks GT2 F4)|Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
11252716|NCT02569723|BG000|Baseline|Carbon C 14 Oxaliplatin and Oxaliplatin|"Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.~Carbon C 14 Oxaliplatin: Intravenous infusion~Oxaliplatin: Intravenous infusion"
11252717|NCT02569723|FG000|Participant Flow|Carbon C 14 Oxaliplatin and Oxaliplatin|"Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.~Carbon C 14 Oxaliplatin: Intravenous infusion~Oxaliplatin: Intravenous infusion"
11252718|NCT02569723|OG000|Outcome|Carbon C 14 Oxaliplatin and Oxaliplatin|"Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.~Carbon C 14 Oxaliplatin: Intravenous infusion~Oxaliplatin: Intravenous infusion"
11252719|NCT02569723|EG000|Reported Event|Carbon C 14 Oxaliplatin and Oxaliplatin|"Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.~Carbon C 14 Oxaliplatin: Intravenous infusion~Oxaliplatin: Intravenous infusion"
11252720|NCT02569801|BG000|Baseline|GDC-0810|Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252721|NCT02569801|BG001|Baseline|Fulvestrant|Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252722|NCT02569801|BG002|Baseline|Total|Total of all reporting groups
11252723|NCT02569801|FG000|Participant Flow|GDC-0810|Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252724|NCT02569801|FG001|Participant Flow|Fulvestrant|Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252725|NCT02569801|OG000|Outcome|GDC-0810|Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252726|NCT02569801|OG001|Outcome|Fulvestrant|Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252727|NCT02569801|EG000|Reported Event|GDC-0810|Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252728|NCT02569801|EG001|Reported Event|Fulvestrant|Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
11252729|NCT02569853|BG000|Baseline|DFN-11 - Double-blind|"DFN-11 active injection upon occurrence of migraine~DFN-11"
11252730|NCT02569853|BG001|Baseline|Placebo - Double-blind|"Placebo injection upon occurrence of migraine~Placebo"
11252731|NCT02569853|BG002|Baseline|Total|Total of all reporting groups
11252732|NCT02569853|FG000|Participant Flow|DFN-11 - Double-Blind|"DFN-11 active injection upon occurrence of migraine~DFN-11"
11252733|NCT02569853|FG001|Participant Flow|Placebo - Double-Blind|"Placebo injection upon occurrence of migraine~Placebo"
11252734|NCT02569853|OG000|Outcome|DFN-11 - Double-Blind|"DFN-11 active injection upon occurrence of migraine~DFN-11"
11252735|NCT02569853|OG001|Outcome|Placebo - Double-Blind|"Placebo injection upon occurrence of migraine~Placebo"
11252736|NCT02569853|OG000|Outcome|DFN-11|"DFN-11 active injection upon occurrence of migraine~DFN-11"
11252737|NCT02569853|OG001|Outcome|Placebo|"Placebo injection upon occurrence of migraine~Placebo"
11252738|NCT02569853|EG000|Reported Event|DFN-11 - Double-blind|"DFN-11 active injection upon occurrence of migraine~DFN-11"
11252739|NCT02569853|EG001|Reported Event|Placebo - Double-blind|"Placebo injection upon occurrence of migraine~Placebo"
11252740|NCT02569892|BG000|Baseline|All Participants|Participants receive sub-threshold macular laser photocoagulation and/or sham treatment with power setting at zero
11252741|NCT02569892|FG000|Participant Flow|Sub-threshold Macular Laser Photocoagulation|Participants that receive treatment with sub-threshold macular laser photocoagulation
11252742|NCT02569892|FG001|Participant Flow|Sham Laser|Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
11252743|NCT02569892|OG000|Outcome|Sub-threshold Macular Laser Photocoagulation|Participants that receive treatment with sub-threshold macular laser photocoagulation
11252744|NCT02569892|OG001|Outcome|Sham Laser|Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
11252745|NCT02569892|EG000|Reported Event|Sub-threshold Macular Laser Photocoagulation|Participants that receive treatment with sub-threshold macular laser photocoagulation
11252746|NCT02569892|EG001|Reported Event|Sham Laser|Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
11252747|NCT02569996|BG000|Baseline|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
11252748|NCT02569996|FG000|Participant Flow|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
11252749|NCT02569996|OG000|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
11252750|NCT02569996|EG000|Reported Event|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
11252751|NCT02570022|BG000|Baseline|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
11252752|NCT02570022|BG001|Baseline|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
11252753|NCT02570022|BG002|Baseline|Total|Total of all reporting groups
11252754|NCT02570022|FG000|Participant Flow|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
11252755|NCT02570022|FG001|Participant Flow|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
11252756|NCT02570022|OG000|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
11252757|NCT02570022|OG001|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
11252758|NCT02570022|EG000|Reported Event|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
11252759|NCT02570022|EG001|Reported Event|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
11252760|NCT02570074|BG000|Baseline|Fosfomycin - 3 Doses QoD/7 Doses QD|"Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.~Fosfomycin: Broad spectrum antibiotic"
11252761|NCT02570074|BG001|Baseline|Fosfomycin - 7 Doses QD/3 Doses QoD|"Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.~Fosfomycin: Broad spectrum antibiotic"
11252762|NCT02570074|BG002|Baseline|Total|Total of all reporting groups
11252763|NCT02570074|FG000|Participant Flow|Fosfomycin - 3 Doses QoD/7 Doses QD|"Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.~Fosfomycin: Broad spectrum antibiotic"
11252764|NCT02570074|FG001|Participant Flow|Fosfomycin - 7 Doses QD/3 Doses QoD|"Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.~Fosfomycin: Broad spectrum antibiotic"
11252765|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD Regimen|The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
11252766|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD Regimen|The number of all AE is summarized by treatment but not sequence. The total number of subjects analyzed is 19.
11252767|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD|The analysis is by Dosing Regimen
11252768|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD|The analysis is by by dosing regimen
11252769|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD Regimen|The analysis is by dosing regimen.
11252770|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD Regimen|The analysis is by dosing regimen.
11252771|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD|"Fosfomycin given as a 3 gm dose, every other day for 3 doses.~Fosfomycin: Broad spectrum antibiotic"
11252772|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD|"Fosfomycin given as a 3 gm dose, once a day for 7 doses~Fosfomycin: Broad spectrum antibiotic"
11252773|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD Regimen|The number of all AE is summarized by regimen but not sequence. The total number of subjects analyzed is 18.
11252774|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD Regimen|The number of all AE is summarized by regimen but not sequence. The total number of subjects analyzed is 18.
11252775|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD|the analysis is by Dosing Regimen
11252776|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD|the analysis is by by dosing regimen
11252777|NCT02570074|OG000|Outcome|Fosfomycin - 3 Doses QoD/7 Doses QD|"Fosfomycin given as a 3 gm dose, every other day for 3 doses, followed by 3 gm dose, once a day for 7 doses.~Fosfomycin: Broad spectrum antibiotic"
11252778|NCT02570074|OG001|Outcome|Fosfomycin - 7 Doses QD/3 Doses QoD|"Fosfomycin given as a 3 gm dose, once a day for 7 doses, followed by 3 gm dose, every other day for 3 doses.~Fosfomycin: Broad spectrum antibiotic"
11252779|NCT02570074|EG000|Reported Event|Fosfomycin - 3 Doses QoD|"Fosfomycin given as a 3 gm dose, every other day for 3 doses~Fosfomycin: Broad spectrum antibiotic"
11252780|NCT02570074|EG001|Reported Event|Fosfomycin - 7 Doses QD|"Fosfomycin given as a 3 gm dose, once a day for 7 doses~Fosfomycin: Broad spectrum antibiotic"
11252781|NCT02570126|BG000|Baseline|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252782|NCT02570126|BG001|Baseline|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252783|NCT02570126|BG002|Baseline|Total|Total of all reporting groups
11252784|NCT02570126|FG000|Participant Flow|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252785|NCT02570126|FG001|Participant Flow|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252786|NCT02570126|OG000|Outcome|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252787|NCT02570126|OG001|Outcome|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252788|NCT02570126|EG000|Reported Event|VAR_HSA_F Group|2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252789|NCT02570126|EG001|Reported Event|VAR Group|2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
11252790|NCT02570139|BG000|Baseline|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.~Cavilon Advanced Skin Protectant: The liquid barrier film flows from the applicator and dries quickly on the skin."
11252791|NCT02570139|BG001|Baseline|ConvaTec Sensi-Care Protective Barrier|"Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.~ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence."
11252792|NCT02570139|BG002|Baseline|Total|Total of all reporting groups
11252793|NCT02570139|FG000|Participant Flow|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.~Cavilon Advanced Skin Protectant: The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence."
11252794|NCT02570139|FG001|Participant Flow|ConvaTec Sensi-Care Protective Barrier|"Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.~ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence."
11252795|NCT02570139|OG000|Outcome|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.~Cavilon Advanced Skin Protectant: The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence."
11252796|NCT02570139|OG001|Outcome|ConvaTec Sensi-Care Protective Barrier|"Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.~ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence."
11252797|NCT02570139|EG000|Reported Event|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.~Cavilon Advanced Skin Protectant: The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence."
11252798|NCT02570139|EG001|Reported Event|ConvaTec Sensi-Care Protective Barrier|"Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.~ConvaTec Sensi-Care Protective Barrier: Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence."
11252799|NCT02570152|BG000|Baseline|Study Group|Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
11252800|NCT02570152|FG000|Participant Flow|Study Group|Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
11252801|NCT02570152|OG000|Outcome|Study Group|Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
11252802|NCT02570152|EG000|Reported Event|Study Group|Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
11252803|NCT02570165|BG000|Baseline|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
11252804|NCT02570165|BG001|Baseline|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252805|NCT02570165|BG002|Baseline|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252806|NCT02570165|BG003|Baseline|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252807|NCT02570165|BG004|Baseline|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252808|NCT02570165|BG005|Baseline|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252809|NCT02570165|BG006|Baseline|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
11252810|NCT02570165|BG007|Baseline|Total|Total of all reporting groups
11252811|NCT02570165|FG000|Participant Flow|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
11252812|NCT02570165|FG001|Participant Flow|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252813|NCT02570165|FG002|Participant Flow|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252814|NCT02570165|FG003|Participant Flow|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252815|NCT02570165|FG004|Participant Flow|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252816|NCT02570165|FG005|Participant Flow|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11341885|NCT03691844|FG002|Participant Flow|Placebo BID|"on the target knee~Placebo gel twice daily.~BID: twice a day/ twice daily"
11252817|NCT02570165|FG006|Participant Flow|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
11252818|NCT02570165|OG000|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
11252819|NCT02570165|OG001|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252820|NCT02570165|OG002|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252821|NCT02570165|OG003|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252822|NCT02570165|OG004|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252823|NCT02570165|OG005|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252824|NCT02570165|OG006|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
11252825|NCT02570165|EG000|Reported Event|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
11252826|NCT02570165|EG001|Reported Event|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252827|NCT02570165|EG002|Reported Event|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
11252828|NCT02570165|EG003|Reported Event|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252829|NCT02570165|EG004|Reported Event|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252830|NCT02570165|EG005|Reported Event|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
11252831|NCT02570165|EG006|Reported Event|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
11286391|NCT02887521|EG000|Reported Event|Pulmonary Rehabilitation (PR)|"Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery. Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process. Patients will also receive a log for recording their efforts and notes for every day until the day of surgery. A video recording of the intervention from start to finish will be provided to all patients. The video recording should be played in all 10 sessions at the registering site. The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~education: pulmonary rehabilitation participant manual~rehabilitation: pulmonary rehabilitation~surgery: patients undergo surgery"
11286392|NCT02887521|EG001|Reported Event|Standard of Care|"Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery. The patients will not be asked to return the pedometer. The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient. The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site. Patients undergo surgery and will be followed until 6 months following surgery. Patients complete follow up questionnaires at 3 and 6 months after discharge.~pedometer: receive a pedometer~education: receive a pamphlet with exercises plus the standard course of care~surgery: patients undergo surgery"
11286393|NCT02887989|BG000|Baseline|Virtual Reality|"Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Virtual Reality: A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game."
11286394|NCT02887989|BG001|Baseline|In-Room Television|"Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Health and Wellness Channel: Relaxing content broadcast passively on the patient in-room television channel."
11286395|NCT02887989|BG002|Baseline|Total|Total of all reporting groups
11252832|NCT02570295|BG000|Baseline|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
11252833|NCT02570295|BG001|Baseline|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
11252834|NCT02570295|BG002|Baseline|Total|Total of all reporting groups
11252835|NCT02570295|FG000|Participant Flow|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
11252836|NCT02570295|FG001|Participant Flow|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
11252837|NCT02570295|OG000|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
10969888|NCT00908037|BG002|Baseline|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
10969889|NCT00908037|BG003|Baseline|Part 2 (Randomized Period) Cohort 2-Placebo|Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
10969890|NCT00908037|BG004|Baseline|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
10969891|NCT00908037|BG005|Baseline|Part 2 (Randomized Period) Cohort 3-Placebo|Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969892|NCT00908037|BG006|Baseline|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
10969893|NCT00908037|BG007|Baseline|Total|Total of all reporting groups
11252838|NCT02570295|OG001|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
11252839|NCT02570295|EG000|Reported Event|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
11252840|NCT02570295|EG001|Reported Event|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
11286396|NCT02887989|FG000|Participant Flow|Virtual Reality|"Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Virtual Reality: A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game."
11286397|NCT02887989|FG001|Participant Flow|In-Room Television|"Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Health and Wellness Channel: Relaxing content broadcast passively on the patient in-room television channel."
11252841|NCT02570425|BG000|Baseline|SYMBICORT Turbohaler® First, Then Spiromax®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
11252842|NCT02570425|BG001|Baseline|Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
11252843|NCT02570425|BG002|Baseline|Total|Total of all reporting groups
11252844|NCT02570425|FG000|Participant Flow|Placebo Comparator: Spiromax Followed by Turbohaler|Training on BF Spiromax followed by SYMBICORT Turbohaler
11252845|NCT02570425|FG001|Participant Flow|Placebo Comparator: Turbohaler Followed by Spiromax|Training on SYMBICORT Turbohaler followed by BF Spiromax
11252846|NCT02570425|OG000|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
11252847|NCT02570425|OG001|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
11252848|NCT02570425|OG000|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
11252849|NCT02570425|OG001|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
11252850|NCT02570425|OG002|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
11252851|NCT02570425|EG000|Reported Event|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
11252852|NCT02570425|EG001|Reported Event|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
11252853|NCT02570711|BG000|Baseline|Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine|Acalabrutinib 100mg PO BID on Days 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles were repeated every 28 days.
11252854|NCT02570711|BG001|Baseline|Arm 2 - Nab-Paclitaxel and Gemcitabine|Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
11252855|NCT02570711|BG002|Baseline|Total|Total of all reporting groups
11252856|NCT02570711|FG000|Participant Flow|Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine|Acalabrutinib 100mg PO BID on Day 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles were repeated every 28 days.
11252857|NCT02570711|FG001|Participant Flow|Arm 2 - Nab-Paclitaxel and Gemcitabine|Nab-Paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles repeated every 28 days.
11252858|NCT02570711|OG000|Outcome|Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine|"ACP-196 and nab-paclitaxel and gemcitabine~ACP-196: ACP-196 capsule~Nab-paclitaxel: Nab-paclitaxel infusion~Gemcitabine: Gemcitabine infusion"
11252859|NCT02570711|OG001|Outcome|Arm 2 - Nab-Paclitaxel and Gemcitabine|"Nab-paclitaxel and gemcitabine~Nab-paclitaxel: Nab-paclitaxel infusion~Gemcitabine: Gemcitabine infusion"
11252860|NCT02570711|EG000|Reported Event|Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine|Acalabrutinib 100mg PO BID on Days 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
11252861|NCT02570711|EG001|Reported Event|Arm 2 - Nab-Paclitaxel and Gemcitabine|Nab-Paclitaxel 125mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
11252862|NCT02570750|BG000|Baseline|Etanercept: Non Smokers|Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252863|NCT02570750|BG001|Baseline|Etanercept: Smokers|Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252864|NCT02570750|BG002|Baseline|Total|Total of all reporting groups
11252865|NCT02570750|FG000|Participant Flow|Etanercept: Non Smokers|Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252866|NCT02570750|FG001|Participant Flow|Etanercept: Smokers|Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252867|NCT02570750|OG000|Outcome|Etanercept: Non Smokers|Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252868|NCT02570750|OG001|Outcome|Etanercept: Smokers|Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11341886|NCT03691844|FG003|Participant Flow|Voltaren 1% QID|"on the target knee~Voltaren gel 1% applied 4 times a day~QID: 4 times every day"
11341887|NCT03691844|OG000|Outcome|AMZ001 BID|AMZ001 gel twice daily
11252869|NCT02570750|EG000|Reported Event|Etanercept: Non Smokers|Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252870|NCT02570750|EG001|Reported Event|Etanercept: Smokers|Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
11252871|NCT02571049|BG000|Baseline|All Subjects|All subjects who were randomized into the study
11252872|NCT02571049|FG000|Participant Flow|Sumatriptan 3 mg Then 6 mg|Subjects were first dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) and in the next study visit were dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in another migraine attack (total 6 mg active sumatriptan).
11252873|NCT02571049|FG001|Participant Flow|Sumatriptan 6 mg Then 3 mg|Subjects were first dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in one migraine attack (total 6 mg active sumatriptan) and in the next study visit were dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) .
11252874|NCT02571049|OG000|Outcome|Sumatriptan 3 mg|DFN-11 active injection and placebo injection
11252875|NCT02571049|OG001|Outcome|Sumatriptan 6 mg|Two DFN-11 active injections
11252876|NCT02571049|EG000|Reported Event|Sumatriptan 3 mg SC|All subjects who had an AE when treated with sumatriptan 3 mg SC
11252877|NCT02571049|EG001|Reported Event|Sumatriptan 6 mg SC|All subjects who had an AE when treated with sumatriptan 6 mg SC
11252878|NCT02571075|BG000|Baseline|Group 1 - Receives Auricular Acupuncture|"Receives Battlefield Acupuncture (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.~Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin."
11252879|NCT02571075|BG001|Baseline|Group 2 Don't Receive Anything|They do not receive any any acupuncture only standard of care.
11252880|NCT02571075|BG002|Baseline|Total|Total of all reporting groups
11252881|NCT02571075|FG000|Participant Flow|Group 1 - Receives Auricular Acupuncture|"Receives Battlefield Acupuncture (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.~Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin."
11252882|NCT02571075|FG001|Participant Flow|Group 2 Don't Receive Anything|They do not receive any any acupuncture only standard of care.
11252883|NCT02571075|OG000|Outcome|Group 1 - Receives Auricular Acupuncture|"Receives Battlefield Acupuncture (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.~Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin."
11252884|NCT02571075|OG001|Outcome|Group 2 Don't Receive Anything|They do not receive any any acupuncture only standard of care.
11252885|NCT02571075|EG000|Reported Event|Group 1 - Receives Auricular Acupuncture|"Receives Battlefield Acupuncture (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.~Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin."
11252886|NCT02571075|EG001|Reported Event|Group 2 Don't Receive Anything|They do not receive any any acupuncture only standard of care.
11252887|NCT02571153|BG000|Baseline|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
11252888|NCT02571153|BG001|Baseline|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
11252889|NCT02571153|BG002|Baseline|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
11252890|NCT02571153|BG003|Baseline|Total|Total of all reporting groups
11252891|NCT02571153|FG000|Participant Flow|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
11252892|NCT02571153|FG001|Participant Flow|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
11252893|NCT02571153|FG002|Participant Flow|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
11252894|NCT02571153|OG000|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
11252895|NCT02571153|OG001|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
11252896|NCT02571153|OG002|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
11252897|NCT02571153|EG000|Reported Event|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
11252898|NCT02571153|EG001|Reported Event|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
11252899|NCT02571153|EG002|Reported Event|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
11341888|NCT03691844|OG001|Outcome|AMZ001 + Placebo QD|"on the target knee~AMZ001 gel once daily, Placebo gel once daily."
11341889|NCT03691844|OG002|Outcome|Placebo BID|Placebo gel twice daily
11341890|NCT03691844|OG000|Outcome|AMZ001 BID|"on the target knee~AMZ001 gel twice daily."
11252900|NCT02571218|BG000|Baseline|mCPVA|"Subjects in the mCPVA arm will undergo intervention called modified circumferential pulmonary vein ablation, which is considered to be the standard ablation treatment for AF.~mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation."
11252901|NCT02571218|BG001|Baseline|Substrate+mCPVA|"Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.~Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation."
11252902|NCT02571218|BG002|Baseline|Total|Total of all reporting groups
11252903|NCT02571218|FG000|Participant Flow|mCPVA|"Subjects in the mCPVA arm will undergo intervention called modified circumferential pulmonary vein ablation, which is considered to be the standard ablation treatment for AF.~mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation."
11252904|NCT02571218|FG001|Participant Flow|Substrate+mCPVA|"Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.~Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation."
11252905|NCT02571218|OG000|Outcome|mCPVA|"Subjects in the mCPVA arm will undergo intervention called modified circumferential pulmonary vein ablation, which is considered to be the standard ablation treatment for AF.~mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation."
11252906|NCT02571218|OG001|Outcome|Substrate+mCPVA|"Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.~Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation."
11252907|NCT02571218|EG000|Reported Event|mCPVA|"Subjects in the mCPVA arm will undergo intervention called modified circumferential pulmonary vein ablation, which is considered to be the standard ablation treatment for AF.~mCPVA: The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation."
11252908|NCT02571218|EG001|Reported Event|Substrate+mCPVA|"Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.~Substrate+mCPVA: The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation."
11252909|NCT02571244|BG000|Baseline|Motivational Interview Plus Text Message|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping."
11252910|NCT02571244|BG001|Baseline|Control Arm|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended care: None"
11252911|NCT02571244|BG002|Baseline|Total|Total of all reporting groups
11252912|NCT02571244|FG000|Participant Flow|Motivational Interview Plus Text Message|Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
11252913|NCT02571244|FG001|Participant Flow|Control Arm|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended care: None"
11286398|NCT02887989|OG000|Outcome|Virtual Reality|"Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Virtual Reality: A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game."
10969894|NCT00908037|FG000|Participant Flow|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11252914|NCT02571244|OG000|Outcome|Motivational Interview Plus Text Message|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.~Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping"
11252915|NCT02571244|OG001|Outcome|Control Arm|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended care: None"
11252916|NCT02571244|OG000|Outcome|Motivational Interview Plus Text Message|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.~Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping sk"
11252917|NCT02571244|OG000|Outcome|Motivational Interview Plus Text Message|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.~Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping s"
11252918|NCT02571244|OG000|Outcome|Motivational Interview Plus Text Message|Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping sk
11252919|NCT02571244|EG000|Reported Event|Motivational Interview Plus Text Message|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping"
11252920|NCT02571244|EG001|Reported Event|Control Arm|"Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.~Post discharge extended care: None"
11252921|NCT02571439|BG000|Baseline|Surgical TAP|Intra-operative TAP block
11252922|NCT02571439|BG001|Baseline|Conventional TAP|Percutaneous ultrasound guided TAP block
11252923|NCT02571439|BG002|Baseline|Total|Total of all reporting groups
11252924|NCT02571439|FG000|Participant Flow|Surgical TAP Block|"surgeon administered intraoperative TAP block using 0.5% ropivacaine~Surgical TAP block: surgeon administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252925|NCT02571439|FG001|Participant Flow|Conventional TAP Block|"Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine~Conventional TAP block: Anesthesiologist administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252926|NCT02571439|OG000|Outcome|Surgical TAP Block|"surgeon administered intraoperative TAP block using 0.5% ropivacaine~Surgical TAP block: surgeon administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252927|NCT02571439|OG001|Outcome|Conventional TAP Block|"Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine~Conventional TAP block: Anesthesiologist administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252928|NCT02571439|EG000|Reported Event|Surgical TAP Block|"surgeon administered intraoperative TAP block using 0.5% ropivacaine~Surgical TAP block: surgeon administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252929|NCT02571439|EG001|Reported Event|Conventional TAP Block|"Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine~Conventional TAP block: Anesthesiologist administered TAP block~0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block"
11252930|NCT02571452|BG000|Baseline|Brief Behavioral Treatment for Insomnia|"Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.~Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques."
11252931|NCT02571452|BG001|Baseline|Progressive Muscle Relaxation Training|"Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.~Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT."
11252932|NCT02571452|BG002|Baseline|Total|Total of all reporting groups
11252933|NCT02571452|FG000|Participant Flow|Brief Behavioral Treatment for Insomnia|"Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.~Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques."
11252934|NCT02571452|FG001|Participant Flow|Progressive Muscle Relaxation Training|"Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.~Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT."
11252935|NCT02571452|OG000|Outcome|Brief Behavioral Treatment for Insomnia|"Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.~Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques."
11252936|NCT02571452|OG001|Outcome|Progressive Muscle Relaxation|"Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.~Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT."
11286399|NCT02887989|OG001|Outcome|In-Room Television|"Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Health and Wellness Channel: Relaxing content broadcast passively on the patient in-room television channel."
11341891|NCT03691844|OG002|Outcome|Placebo BID|"on the target knee~Placebo gel twice daily."
11341892|NCT03691844|OG003|Outcome|Voltaren 1% QID|on the target knee Voltaren gel 1% applied 4 times a day QID: 4 times every day
11341893|NCT03691844|EG000|Reported Event|AMZ001 BID|AMZ001 gel twice daily
11341894|NCT03691844|EG001|Reported Event|AMZ001 + Placebo QD|"on the target knee~AMZ001 gel once daily, Placebo gel once daily."
11341895|NCT03691844|EG002|Reported Event|Placebo BID|Placebo gel twice daily
11252937|NCT02571452|EG000|Reported Event|Brief Behavioral Treatment for Insomnia|"Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.~Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques."
11252938|NCT02571452|EG001|Reported Event|Progressive Muscle Relaxation Training|"Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.~Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT."
11252939|NCT02571634|BG000|Baseline|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
11252940|NCT02571634|FG000|Participant Flow|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
11252941|NCT02571634|OG000|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
11252942|NCT02571634|OG000|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
11252943|NCT02571634|EG000|Reported Event|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
11252944|NCT02571777|BG000|Baseline|QVM149 150/50/160 µg o.d.|QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252945|NCT02571777|BG001|Baseline|QVM149 150/50/80 µg o.d.|QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252946|NCT02571777|BG002|Baseline|QMF149 150/320 µg o.d.|QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252947|NCT02571777|BG003|Baseline|QMF149 150/160 µg o.d.|QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252948|NCT02571777|BG004|Baseline|Salmeterol/Fluticasone 50/500 μg b.i.d.|Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
11252949|NCT02571777|BG005|Baseline|Total|Total of all reporting groups
11252950|NCT02571777|FG000|Participant Flow|QVM149 150/50/160 µg o.d.|QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252951|NCT02571777|FG001|Participant Flow|QVM149 150/50/80 µg o.d.|QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252952|NCT02571777|FG002|Participant Flow|QMF149 150/320 µg o.d.|QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252953|NCT02571777|FG003|Participant Flow|QMF149 150/160 µg o.d.|QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252954|NCT02571777|FG004|Participant Flow|Salmeterol/Fluticasone 50/500 μg b.i.d.|Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
11252955|NCT02571777|OG000|Outcome|QVM149 150/50/160 µg o.d.|QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252956|NCT02571777|OG001|Outcome|QVM149 150/50/80 µg o.d.|QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252957|NCT02571777|OG002|Outcome|QMF149 150/320 µg o.d.|QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252958|NCT02571777|OG003|Outcome|QMF149 150/160 µg o.d.|QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252959|NCT02571777|OG004|Outcome|Salmeterol/Fluticasone 50/500 μg b.i.d.|Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
11252960|NCT02571777|EG000|Reported Event|QVM149 150/50/160 μg o.d.|QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252961|NCT02571777|EG001|Reported Event|QVM149 150/50/80 μg o.d.|QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252962|NCT02571777|EG002|Reported Event|QMF149 150/320 μg o.d.|QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252963|NCT02571777|EG003|Reported Event|QMF149 150/160 μg o.d.|QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
11252964|NCT02571777|EG004|Reported Event|Salmeterol/Fluticasone 50/500 μg b.i.d.|Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
11341896|NCT03691844|EG003|Reported Event|Voltaren 1% QID|"on the target knee~Voltaren gel 1% applied 4 times a day"
11252965|NCT02571972|BG000|Baseline|Dorzolamide-timolol|"On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.~Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.~Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits~At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients~Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration"
11252966|NCT02571972|FG000|Participant Flow|Dorzolamide-timolol|On enrollment, eligible patients will be started on topical dorzolamide 2%-timolol 0.5% 1 drop in the study eye twice daily for the study duration
11252967|NCT02571972|OG000|Outcome|Dorzolamide-timolol|"On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.~Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.~Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits~At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients~Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration"
11252968|NCT02571972|EG000|Reported Event|Dorzolamide-timolol|"On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit.~Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration.~Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits~At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients~Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration"
11252969|NCT02572076|BG000|Baseline|Motus Cleansing System (MCS)|"The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.~Motus Cleansing System"
11252970|NCT02572076|FG000|Participant Flow|Motus Cleansing System (MCS)|The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
11252971|NCT02572076|OG000|Outcome|Motus Cleansing System (MCS)|The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
11252972|NCT02572076|EG000|Reported Event|Motus Cleansing System (MCS)|The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
11252973|NCT02572167|BG000|Baseline|Part 1: Staggered Dose|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252974|NCT02572167|BG001|Baseline|Part 2: Staggered Dose Expansion|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252975|NCT02572167|BG002|Baseline|Part 3: Same-day Dose|"Brentuximab vedotin plus nivolumab~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252976|NCT02572167|BG003|Baseline|Total|Total of all reporting groups
11252977|NCT02572167|FG000|Participant Flow|Part 1: Staggered Dose|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252978|NCT02572167|FG001|Participant Flow|Part 2: Staggered Dose Expansion|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252979|NCT02572167|FG002|Participant Flow|Part 3: Same-day Dose|"Brentuximab vedotin plus nivolumab~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252980|NCT02572167|OG000|Outcome|Part 1: Staggered Dose|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252981|NCT02572167|OG001|Outcome|Part 2: Staggered Dose Expansion|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252982|NCT02572167|OG002|Outcome|Part 3: Same-day Dose|"Brentuximab vedotin plus nivolumab~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252983|NCT02572167|EG000|Reported Event|Part 1: Staggered Dose|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252984|NCT02572167|EG001|Reported Event|Part 2: Staggered Dose Expansion|"Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only.~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252985|NCT02572167|EG002|Reported Event|Part 3: Same-day Dose|"Brentuximab vedotin plus nivolumab~brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles~nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles"
11252986|NCT02572388|BG000|Baseline|Group 1|"10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252987|NCT02572388|BG001|Baseline|Group 2|"50µg of R21 on days 0, 28, and 56.~R21"
11252988|NCT02572388|BG002|Baseline|Group 3|"50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252989|NCT02572388|BG003|Baseline|Group 4|"2µg of R21 mixed with 50µg of Matrix-M~R21~Matrix-M1"
11252990|NCT02572388|BG004|Baseline|Total|Total of all reporting groups
11252991|NCT02572388|FG000|Participant Flow|Group 1|"10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252992|NCT02572388|FG001|Participant Flow|Group 2|"50µg of R21 on days 0, 28, and 56.~R21"
11252993|NCT02572388|FG002|Participant Flow|Group 3|"50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252994|NCT02572388|FG003|Participant Flow|Group 4|"2µg of R21 mixed with 50µg of Matrix-M~R21~Matrix-M1"
11252995|NCT02572388|OG000|Outcome|Group 1|"10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252996|NCT02572388|OG001|Outcome|Group 2|"50µg of R21 on days 0, 28, and 56.~R21"
11252997|NCT02572388|OG002|Outcome|Group 3|"50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11252998|NCT02572388|OG003|Outcome|Group 4|"2µg of R21 mixed with 50µg of Matrix-M~R21~Matrix-M1"
11252999|NCT02572388|EG000|Reported Event|Group 1|"10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11253000|NCT02572388|EG001|Reported Event|Group 2|"50µg of R21 on days 0, 28, and 56.~R21"
11253001|NCT02572388|EG002|Reported Event|Group 3|"50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.~R21~Matrix-M1"
11253002|NCT02572388|EG003|Reported Event|Group 4|"2µg of R21 mixed with 50µg of Matrix-M~R21~Matrix-M1"
11253003|NCT02572401|BG000|Baseline|HIV Risk Reduction Only|"STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use."
11253004|NCT02572401|BG001|Baseline|No-Intervention No-Text Message Control|Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
11253005|NCT02572401|BG002|Baseline|HIV Risk Reduction and Text Messaging|"STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.~Text Messaging Intervention:"
11253006|NCT02572401|BG003|Baseline|Text Messaging Only|"Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.~Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex."
11253007|NCT02572401|BG004|Baseline|Total|Total of all reporting groups
11253008|NCT02572401|FG000|Participant Flow|HIV Risk Reduction Only|"STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use."
11253009|NCT02572401|FG001|Participant Flow|No-Intervention No-Text Message Control|Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
11253010|NCT02572401|FG002|Participant Flow|HIV Risk Reduction and Text Messaging|"STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.~Text Messaging Intervention:"
11253011|NCT02572401|FG003|Participant Flow|Text Messaging Only|"Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.~Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex."
11253012|NCT02572401|OG000|Outcome|HIV Risk Reduction Only|"STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use."
11253013|NCT02572401|OG001|Outcome|No-Intervention No-Text Message Control|Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
11253014|NCT02572401|OG002|Outcome|HIV Risk Reduction and Text Messaging|"STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.~Text Messaging Intervention:"
11253015|NCT02572401|OG003|Outcome|Text Messaging Only|"Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.~Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex."
11253016|NCT02572401|EG000|Reported Event|HIV Risk Reduction Only|"STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use."
11253017|NCT02572401|EG001|Reported Event|No-Intervention No-Text Message Control|Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
11286400|NCT02887989|EG000|Reported Event|Virtual Reality|"Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Virtual Reality: A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game."
11286401|NCT02887989|EG001|Reported Event|In-Room Television|"Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.~Health and Wellness Channel: Relaxing content broadcast passively on the patient in-room television channel."
11286402|NCT02888080|BG000|Baseline|ACZ885|ACZ885 (300 mg s.c. once monthly for 6 months)
11253018|NCT02572401|EG002|Reported Event|HIV Risk Reduction and Text Messaging|"STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.~STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.~Text Messaging Intervention:"
11253019|NCT02572401|EG003|Reported Event|Text Messaging Only|"Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.~Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex."
11253020|NCT02572427|BG000|Baseline|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
11253021|NCT02572427|BG001|Baseline|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
11253022|NCT02572427|BG002|Baseline|Total|Total of all reporting groups
11253023|NCT02572427|FG000|Participant Flow|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
11253024|NCT02572427|FG001|Participant Flow|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
11253025|NCT02572427|OG000|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
11253026|NCT02572427|OG001|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
11253027|NCT02572427|EG000|Reported Event|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
11253028|NCT02572427|EG001|Reported Event|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
11253029|NCT02572570|BG000|Baseline|Posterior Composite Resin Restoration|Posterior teeth were restored with two tooth-colored restorative materials using different techniques. Increments that were either up to 2 mm or 5 mm were placed. Twenty-two participants received one restoration and five participants received two restorations of each material, for a total of 64 restorations in 27 patients.
11253030|NCT02572570|FG000|Participant Flow|Posterior Composite Resin Restoration|Posterior teeth were restored with two tooth-colored restorative materials using different techniques. Increments that were either up to 2 mm or 5 mm were placed. Twenty-two participants received one restoration and five participants received two restorations of each material, for a total of 64 restorations in 27 patients.
11253031|NCT02572570|OG000|Outcome|Filtek Bulk Fill Posterior|Dental material for posterior restoration placed in increments up to 5 mm in thickness.
11253032|NCT02572570|OG001|Outcome|Filtek Supreme Ultra|Dental material for posterior restoration placed in increments up to 2 mm in thickness.
11253033|NCT02572570|EG000|Reported Event|Filtek Bulk Fill Posterior|Dental material for posterior restoration placed in increments up to 5 mm in thickness.
11253034|NCT02572570|EG001|Reported Event|Filtek Supreme Ultra|Dental material for posterior restoration placed in increments up to 2 mm in thickness.
11253035|NCT02572570|EG002|Reported Event|All Participants|Includes all participants, who received both interventions.
11253036|NCT02572609|BG000|Baseline|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
11253037|NCT02572609|BG001|Baseline|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
11253038|NCT02572609|BG002|Baseline|Total|Total of all reporting groups
11253039|NCT02572609|FG000|Participant Flow|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
11253040|NCT02572609|FG001|Participant Flow|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
11253041|NCT02572609|OG000|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
11253042|NCT02572609|OG001|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
11253043|NCT02572609|EG000|Reported Event|Mucosolvan® Adult Syrup|
11253044|NCT02572609|EG001|Reported Event|Ambroxol Hydrochloride Soft Pastille|
11253045|NCT02572752|BG000|Baseline|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253046|NCT02572752|BG001|Baseline|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253047|NCT02572752|BG002|Baseline|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253048|NCT02572752|BG003|Baseline|Total|Total of all reporting groups
11253049|NCT02572752|FG000|Participant Flow|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253050|NCT02572752|FG001|Participant Flow|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253051|NCT02572752|FG002|Participant Flow|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
11253052|NCT02572752|OG000|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
11253053|NCT02572752|OG001|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
11253054|NCT02572752|OG002|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
11253055|NCT02572752|EG000|Reported Event|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose of nintedanib soft gelatine capsule (Test treatment (T)) , 200 mg (1x200mg) with about 240 mL of water.
11253056|NCT02572752|EG001|Reported Event|Nintedanib, Reference Treatment (R1 & R2)|Subjects were treated twice with single oral dose of nintedanib soft gelatine capsule (Reference treatment (R1 & R2)), 200 mg (2x100mg) with about 240 mL of water.
11253057|NCT02572817|BG000|Baseline|High-titer Anti-influenza Plasma mITT|High-titer anti-influenza mITT (modified intent to treat) is the subgroup of high-titer anti-influenza plasma participants who received any study plasma
11253058|NCT02572817|BG001|Baseline|Low-titer Anti-influenza Plasma mITT|Low-titer anti-influenza mITT (modified intent to treat) is the subgroup of low-titer anti-influenza plasma participants who received any study plasma
11253059|NCT02572817|BG002|Baseline|Total|Total of all reporting groups
11253060|NCT02572817|FG000|Participant Flow|High-titer Anti-influenza Plasma mITT|High-titer anti-influenza mITT (modified intent to treat) is the subgroup of high-titer anti-influenza plasma participants who received any study plasma
11286403|NCT02888080|BG001|Baseline|Placebo|Placebo (s.c. once monthly for 6 months)
11253061|NCT02572817|FG001|Participant Flow|Low-titer Anti-influenza Plasma mITT|Low-titer anti-influenza mITT (modified intent to treat) is the subgroup of low-titer anti-influenza plasma participants who received any study plasma
11253062|NCT02572817|OG000|Outcome|High-titer Anti-influenza Plasma mITT|High-titer anti-influenza mITT (modified intent to treat) is the subgroup of high-titer anti-influenza plasma participants who received any study plasma
11253063|NCT02572817|OG001|Outcome|Low-titer Anti-influenza Plasma mITT|Low-titer anti-influenza mITT (modified intent to treat) is the subgroup of low-titer anti-influenza plasma participants who received any study plasma
11253064|NCT02572817|EG000|Reported Event|High-titer Anti-influenza Plasma mITT|High-titer anti-influenza mITT (modified intent to treat) is the subgroup of high-titer anti-influenza plasma participants who received any study plasma
11253065|NCT02572817|EG001|Reported Event|Low-titer Anti-influenza Plasma mITT|Low-titer anti-influenza mITT (modified intent to treat) is the subgroup of low-titer anti-influenza plasma participants who received any study plasma
11253066|NCT02573012|BG000|Baseline|Tocilizumab+Prednisone (Tapering Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) with 1 mg decrements every 4 weeks or matching placebo orally for 24 weeks.
11253067|NCT02573012|BG001|Baseline|Tocilizumab+Prednisone (Constant Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) or matching placebo orally for 24 weeks.
11253068|NCT02573012|BG002|Baseline|Total|Total of all reporting groups
11253069|NCT02573012|FG000|Participant Flow|Tocilizumab+Prednisone (Tapering Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) with 1 mg decrements every 4 weeks or matching placebo orally for 24 weeks.
11253070|NCT02573012|FG001|Participant Flow|Tocilizumab+Prednisone (Constant Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) or matching placebo orally for 24 weeks.
11253071|NCT02573012|OG000|Outcome|Tocilizumab+Prednisone (Tapering Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) with 1 mg decrements every 4 weeks or matching placebo orally for 24 weeks.
11253072|NCT02573012|OG001|Outcome|Tocilizumab+Prednisone (Constant Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) or matching placebo orally for 24 weeks.
11253073|NCT02573012|EG000|Reported Event|Tocilizumab+Prednisone (Tapering Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) with 1 mg decrements every 4 weeks or matching placebo orally for 24 weeks.
11253074|NCT02573012|EG001|Reported Event|Tocilizumab+Prednisone (Constant Dose)|Participants will receive tocilizumab at a dose of 162 milligram (mg) once a week subcutaneously or 8 mg/kg intravenously every 4 weeks; and prednisone at a dose of 5 milligram per day (mg/day) or matching placebo orally for 24 weeks.
11253075|NCT02573155|BG000|Baseline|Overall Population - Part 1|All individuals in Part 1 (patients who received single doses of AZD8871 [50, 400, 1800 μg for Cohort 1; 200, 900, 2100 μg for Cohort 2], or placebo, in 3 treatment periods separated by washout periods of 14 days).
11253076|NCT02573155|BG001|Baseline|Overall Population - Part 2|All individuals involved in Part 2 (patients who received single doses of AZD8871 [400 and 1800 μg], placebo, indacaterol 150 μg, or tiotropium 18 μg, in 5 treatment periods separated by washout periods of 7-21 days.
11253077|NCT02573155|BG002|Baseline|Total|Total of all reporting groups
11253078|NCT02573155|FG000|Participant Flow|Overall Population - Part 1|All individuals in Part 1 (patients who received single doses of AZD8871 [50, 400, 1800 μg for Cohort 1; 200, 900, 2100 μg for Cohort 2], or placebo, in 3 treatment periods separated by washout periods of 14 days).
11253079|NCT02573155|FG001|Participant Flow|Overall Population - Part 2|All individuals involved in Part 2 (patients who received single doses of AZD8871 [400 and 1800 μg], placebo, indacaterol 150 μg, or tiotropium 18 μg, in 5 treatment periods separated by washout periods of 7-21 days.
11253080|NCT02573155|OG000|Outcome|AZD8871 50 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253081|NCT02573155|OG001|Outcome|AZD8871 200 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253082|NCT02573155|OG002|Outcome|AZD8871 400 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253083|NCT02573155|OG003|Outcome|AZD8871 900 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253084|NCT02573155|OG004|Outcome|AZD8871 1800 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253085|NCT02573155|OG005|Outcome|AZD8871 2100 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253086|NCT02573155|OG006|Outcome|Placebo (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253087|NCT02573155|OG007|Outcome|AZD8871 400 μg (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253088|NCT02573155|OG008|Outcome|AZD8871 1800 μg (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253089|NCT02573155|OG009|Outcome|Indacaterol 150 μg (Part 2)|Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)
11253090|NCT02573155|OG010|Outcome|Tiotropium 18 μg (Part 2)|Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
11253091|NCT02573155|OG011|Outcome|Placebo (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253092|NCT02573155|EG000|Reported Event|AZD8871 50 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253093|NCT02573155|EG001|Reported Event|AZD8871 200 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11286404|NCT02888080|BG002|Baseline|Total|Total of all reporting groups
11253094|NCT02573155|EG002|Reported Event|AZD8871 400 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253095|NCT02573155|EG003|Reported Event|AZD8871 900 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253096|NCT02573155|EG004|Reported Event|AZD8871 1800 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253097|NCT02573155|EG005|Reported Event|AZD8871 2100 μg (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253098|NCT02573155|EG006|Reported Event|Placebo (Part 1)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253099|NCT02573155|EG007|Reported Event|AZD8871 400 μg (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253100|NCT02573155|EG008|Reported Event|AZD8871 1800 μg (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253101|NCT02573155|EG009|Reported Event|Indacaterol 150 μg (Part 2)|Single-dose, oral inhalation by Onbrez Breezhaler® single-dose dry powder inhaler (DPI)
11253102|NCT02573155|EG010|Reported Event|Tiotropium 18 μg (Part 2)|Single-dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI)
11253103|NCT02573155|EG011|Reported Event|Placebo (Part 2)|Single-dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
11253104|NCT02573181|BG000|Baseline|V114|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
11253105|NCT02573181|BG001|Baseline|Prevnar 13™|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11253106|NCT02573181|BG002|Baseline|Total|Total of all reporting groups
11253107|NCT02573181|FG000|Participant Flow|V114|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
11253108|NCT02573181|FG001|Participant Flow|Prevnar 13™|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11253109|NCT02573181|OG000|Outcome|V114|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
11253110|NCT02573181|OG001|Outcome|Prevnar 13™|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11253111|NCT02573181|EG000|Reported Event|V114|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
11253112|NCT02573181|EG001|Reported Event|Prevnar 13®|Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
11253113|NCT02573246|BG000|Baseline|Cognitive Restructuring+rTMS (Left)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11253114|NCT02573246|BG001|Baseline|Cognitive Restructuring + Sham rTMS|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11253115|NCT02573246|BG002|Baseline|Cognitive Restructuring+rTMS (Right)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11286405|NCT02888080|FG000|Participant Flow|ACZ885|ACZ885 (300 mg s.c. once monthly for 6 months)
11286406|NCT02888080|FG001|Participant Flow|Placebo|Placebo (s.c. once monthly for 6 months)
11286407|NCT02888080|OG000|Outcome|ACZ885|ACZ885 (300 mg s.c. once monthly for 6 months)
11286408|NCT02888080|OG001|Outcome|Placebo|Placebo (s.c. once monthly for 6 months)
11253116|NCT02573246|BG003|Baseline|Cognitive Restructuring+rTMS (Left) With Functional Targeting|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11253117|NCT02573246|BG004|Baseline|Cognitive Restructuring + Sham rTMS With Functional Targeting|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11253118|NCT02573246|BG005|Baseline|Total|Total of all reporting groups
11253119|NCT02573246|FG000|Participant Flow|Cognitive Restructuring+rTMS (Left)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11253120|NCT02573246|FG001|Participant Flow|Cognitive Restructuring + Sham rTMS|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11253121|NCT02573246|FG002|Participant Flow|Cognitive Restructuring+rTMS (Right)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11253122|NCT02573246|FG003|Participant Flow|Cognitive Restructuring+rTMS (Left) With Functional Targeting|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses"
11253123|NCT02573246|FG004|Participant Flow|Cognitive Restructuring + Sham rTMS With Functional Targeting|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11286409|NCT02888080|EG000|Reported Event|ACZ885 300 mg|ACZ885 300 mg
11286410|NCT02888080|EG001|Reported Event|Placebo|Placebo (s.c. once monthly for 6 months)
11286411|NCT02888093|BG000|Baseline|Absorbable|"Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11286412|NCT02888093|BG001|Baseline|Permanent|"Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11286413|NCT02888093|BG002|Baseline|Total|Total of all reporting groups
11253124|NCT02573246|OG000|Outcome|Cognitive Restructuring+rTMS (Left)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253125|NCT02573246|OG001|Outcome|Cognitive Restructuring + Sham rTMS|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation."
11253126|NCT02573246|OG002|Outcome|Cognitive Restructuring+rTMS (Right)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253127|NCT02573246|OG003|Outcome|Cognitive Restructuring+rTMS (Left) With Functional Targeting|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253128|NCT02573246|OG004|Outcome|Cognitive Restructuring + Sham rTMS With Functional Targeting|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation."
11253129|NCT02573246|OG000|Outcome|Cognitive Restructuring+rTMS (Left)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.~rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times"
11286414|NCT02888093|FG000|Participant Flow|Absorbable|"Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11253130|NCT02573246|OG001|Outcome|Cognitive Restructuring + Sham rTMS|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11253131|NCT02573246|OG002|Outcome|Cognitive Restructuring+rTMS (Right)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times"
11253132|NCT02573246|OG003|Outcome|Cognitive Restructuring+rTMS (Left) With Functional Targeting|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 10 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses. (4s train 26 s inter train interval). the 10-minute administration was repeated 4 times"
11253133|NCT02573246|OG004|Outcome|Cognitive Restructuring + Sham rTMS With Functional Targeting|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant."
11253134|NCT02573246|EG000|Reported Event|Cognitive Restructuring+rTMS (Left)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253135|NCT02573246|EG001|Reported Event|Cognitive Restructuring + Sham rTMS|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation."
11253136|NCT02573246|EG002|Reported Event|Cognitive Restructuring+rTMS (Right)|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253137|NCT02573246|EG003|Reported Event|Cognitive Restructuring+rTMS (Left) With Functional Targeting|"Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.~rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring."
11253138|NCT02573246|EG004|Reported Event|Cognitive Restructuring + Sham rTMS With Functional Targeting|"Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.~Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.~Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation."
11253139|NCT02573311|BG000|Baseline|Cohort 1|Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
11253140|NCT02573311|BG001|Baseline|Cohort 2|Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
11253141|NCT02573311|BG002|Baseline|Total|Total of all reporting groups
11253142|NCT02573311|FG000|Participant Flow|Cohort 1|Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
11253143|NCT02573311|FG001|Participant Flow|Cohort 2|Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
11253144|NCT02573311|OG000|Outcome|Cohort 1|Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
11253145|NCT02573311|EG000|Reported Event|Cohort 1|Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS1)
11253146|NCT02573311|EG001|Reported Event|Cohort 2|Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS2)
11253147|NCT02573311|EG002|Reported Event|Cohort 1 and 2|Cohort 1 and 2 included all men who answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks) regardless of whether they were currently using the product or not. (TS)
11253148|NCT02573350|BG000|Baseline|Delamanid 100 mg BID + OBR|Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.
11253149|NCT02573350|BG001|Baseline|Delamanid 200 mg BID + OBR|Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
11253150|NCT02573350|BG002|Baseline|Total|Total of all reporting groups
11253151|NCT02573350|FG000|Participant Flow|Delamanid 100 mg BID + OBR|Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on World Health Organization (WHO) guidelines and clinical judgment.
11253152|NCT02573350|FG001|Participant Flow|Delamanid 200 mg BID + OBR|Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
11253153|NCT02573350|OG000|Outcome|Delamanid 100 mg BID + OBR|Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.
11253154|NCT02573350|OG001|Outcome|Delamanid 200 mg BID + OBR|Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
11253155|NCT02573350|OG001|Outcome|Delamanid 200 mg BID + OBR|Participants received delamanid 200 mg (4x50 mg tablets), orally, BID plus OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant may have been titrated to delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of delamanid dose administered during the study.
11253156|NCT02573350|OG000|Outcome|Delamanid 100mg BID + OBR|Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.
11253157|NCT02573350|OG001|Outcome|Delamanid 200mg BID + OBR|Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
10969895|NCT00908037|FG001|Participant Flow|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969896|NCT00908037|FG002|Participant Flow|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969897|NCT00908037|FG003|Participant Flow|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
10969898|NCT00908037|FG004|Participant Flow|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11253158|NCT02573350|EG000|Reported Event|Delamanid 100 mg BID + OBR|Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.
11253159|NCT02573350|EG001|Reported Event|Delamanid 200 mg BID + OBR|Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
11253160|NCT02573402|BG000|Baseline|Transcutaneous Tibial Nerve Stimulation|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.~Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis."
11253161|NCT02573402|BG001|Baseline|Control|"Control (Sham stimulation).~Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero."
11253162|NCT02573402|BG002|Baseline|Total|Total of all reporting groups
11253163|NCT02573402|FG000|Participant Flow|Transcutaneous Tibial Nerve Stimulation|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.~Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis."
10969899|NCT00908037|FG005|Participant Flow|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
11253164|NCT02573402|FG001|Participant Flow|Control|"Control (Sham stimulation).~Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero."
11253165|NCT02573402|OG000|Outcome|Transcutaneous Tibial Nerve Stimulation|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.~Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis."
11253166|NCT02573402|OG001|Outcome|Control|"Control (Sham stimulation).~Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero."
11253167|NCT02573402|EG000|Reported Event|Transcutaneous Tibial Nerve Stimulation|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.~Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis."
11253168|NCT02573402|EG001|Reported Event|Control|"Control (Sham stimulation).~Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero."
11253169|NCT02573467|BG000|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253170|NCT02573467|BG001|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
11253171|NCT02573467|BG002|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253172|NCT02573467|BG003|Baseline|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253173|NCT02573467|BG004|Baseline|Total|Total of all reporting groups
11253174|NCT02573467|FG000|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253175|NCT02573467|FG001|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
11253176|NCT02573467|FG002|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253177|NCT02573467|FG003|Participant Flow|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253178|NCT02573467|OG000|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253179|NCT02573467|OG001|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
11253180|NCT02573467|OG002|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253181|NCT02573467|OG003|Outcome|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253182|NCT02573467|EG000|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253183|NCT02573467|EG001|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
11253184|NCT02573467|EG002|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253185|NCT02573467|EG003|Reported Event|Placebo|Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
11253186|NCT02573467|EG004|Reported Event|Pooled Active Treatment Groups|Participants from all 3 BYM338 groups
11253187|NCT02573857|BG000|Baseline|DSM265 P. Falciparum|"Cohort 1: the efficacy of a single administration of 400 mg DSM265 for the clearance of asexual blood stages of P. falciparum will be determined. Activity of a second single dose of 400 mg DSM265 against gametocytes will be assessed in this cohort only if sexual stages are identified by PCR following the initial drug treatment.~DSM265: Oral suspension from bulk powder"
11253188|NCT02573857|BG001|Baseline|OZ439 P. Vivax|"Cohort 2: subjects will be infected with P. vivax by IBSM, then treated with a single 200 mg dose OZ439. If recrudescence occurs following initial drug treatment with 200 mg OZ439, then affected participants who reach the treatment threshold will receive a single 400 mg dose of OZ439.~OZ439: Oral suspension from powder in a bottle"
11253189|NCT02573857|BG002|Baseline|Total|Total of all reporting groups
11253190|NCT02573857|FG000|Participant Flow|DSM265 P. Falciparum|"Cohort 1: the efficacy of a single administration of 400 mg DSM265 for the clearance of asexual blood stages of P. falciparum will be determined. Activity of a second single dose of 400 mg DSM265 against gametocytes will be assessed in this cohort only if sexual stages are identified by PCR following the initial drug treatment.~DSM265: Oral suspension from bulk powder"
11286415|NCT02888093|FG001|Participant Flow|Permanent|"Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11253191|NCT02573857|FG001|Participant Flow|OZ439 P. Vivax|"Cohort 2: subjects will be infected with P. vivax by IBSM, then treated with a single 200 mg dose OZ439. If recrudescence occurs following initial drug treatment with 200 mg OZ439, then affected participants who reach the treatment threshold will receive a single 400 mg dose of OZ439.~OZ439: Oral suspension from powder in a bottle"
11253192|NCT02573857|OG000|Outcome|DSM265 P. Falciparum|"Cohort 1: the efficacy of a single administration of 400 mg DSM265 for the clearance of asexual blood stages of P. falciparum will be determined. Activity of a second single dose of 400 mg DSM265 against gametocytes will be assessed in this cohort only if sexual stages are identified by PCR following the initial drug treatment.~DSM265: Oral suspension from bulk powder"
11253193|NCT02573857|OG001|Outcome|OZ439 P. Vivax|"Cohort 2: subjects will be infected with P. vivax by IBSM, then treated with a single 200 mg dose OZ439. If recrudescence occurs following initial drug treatment with 200 mg OZ439, then affected participants who reach the treatment threshold will receive a single 400 mg dose of OZ439.~OZ439: Oral suspension from powder in a bottle"
11253194|NCT02573857|EG000|Reported Event|DSM265 P. Falciparum|"Cohort 1: the efficacy of a single administration of 400 mg DSM265 for the clearance of asexual blood stages of P. falciparum will be determined. Activity of a second single dose of 400 mg DSM265 against gametocytes will be assessed in this cohort only if sexual stages are identified by PCR following the initial drug treatment.~DSM265: Oral suspension from bulk powder"
11253195|NCT02573857|EG001|Reported Event|OZ439 P. Vivax|"Cohort 2: subjects will be infected with P. vivax by IBSM, then treated with a single 200 mg dose OZ439. If recrudescence occurs following initial drug treatment with 200 mg OZ439, then affected participants who reach the treatment threshold will receive a single 400 mg dose of OZ439.~OZ439: Oral suspension from powder in a bottle"
11253196|NCT02573870|BG000|Baseline|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253197|NCT02573870|BG001|Baseline|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253198|NCT02573870|BG002|Baseline|Total|Total of all reporting groups
11253199|NCT02573870|FG000|Participant Flow|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253200|NCT02573870|FG001|Participant Flow|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
11253201|NCT02573870|OG000|Outcome|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253202|NCT02573870|OG001|Outcome|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253203|NCT02573870|EG000|Reported Event|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253204|NCT02573870|EG001|Reported Event|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
11253205|NCT02573883|BG000|Baseline|Fractionated Carbon Dioxide Laser|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253206|NCT02573883|BG001|Baseline|Clobetasol Propionate|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment
11253207|NCT02573883|BG002|Baseline|Total|Total of all reporting groups
11253208|NCT02573883|FG000|Participant Flow|Clobetasol Propionate- No Crossover|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need. Participants did not cross over.
11253209|NCT02573883|FG001|Participant Flow|Fractionated Carbon Dioxide Laser- No Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart. Then no further treatment."
11253210|NCT02573883|FG002|Participant Flow|Clobetasol Propionate to Laser Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved.~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253211|NCT02573883|FG003|Participant Flow|Fractionated Carbon Dioxide Laser to Clobetasol Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms.~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need."
11253212|NCT02573883|OG000|Outcome|Fractionated Carbon Dioxide Laser|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253213|NCT02573883|OG001|Outcome|Clobetasol Propionate|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment
11253214|NCT02573883|OG000|Outcome|Fractionated Carbon Dioxide Laser- No Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart. Then no further treatment."
11253215|NCT02573883|OG001|Outcome|Clobetasol Propionate- No Crossover|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need. Participants did not cross over.
11253216|NCT02573883|OG002|Outcome|Clobetasol Propionate to Laser Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved.~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253217|NCT02573883|OG003|Outcome|Fractionated Carbon Dioxide Laser to Clobetasol Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms.~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need"
11253218|NCT02573883|OG003|Outcome|Fractionated Carbon Dioxide Laser to Clobetasol Crossover|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms.~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need."
11253219|NCT02573883|EG000|Reported Event|Clobetasol Propionate- 0-6 Months|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need.
11253220|NCT02573883|EG001|Reported Event|Fractionated Carbon Dioxide Laser- 0-6 Months|"Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253221|NCT02573883|EG002|Reported Event|Clobetasol Propionate to Laser Crossover 6-12 Months|"Participants previously in the Clobetasol Propionate 0.05% ointment group. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved.~Fractionated Carbon Dioxide Laser: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart."
11253222|NCT02573883|EG003|Reported Event|Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months|"Participants previously in the Fractionated Carbon Dioxide Laser group choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms.~Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment then as need."
11253223|NCT02573883|EG004|Reported Event|Clobetasol Propionate - No Crossover 6-12 Months|Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment continued as need. No Crossover.
11253224|NCT02573883|EG005|Reported Event|Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months|Participants previoulsly treated with Fractionated Carbon Dioxide Laser choose to not undergo any further treatment.
11253225|NCT02573948|BG000|Baseline|PWID RDS|603 participants
11253226|NCT02573948|FG000|Participant Flow|People Who Injected Drugs (PWID) Respondent Driven Sample (RDS|603 participants recruited through Respondent Driven Sample survey
11253227|NCT02573948|OG000|Outcome|PWID Cohort|250 participants selected among 603 RDS participants
11253228|NCT02573948|OG000|Outcome|HCV Negative Cohort Participants|Cohort participants, HCV negative at RDS
11253229|NCT02573948|OG000|Outcome|HIV Negative Cohort Participants|Cohort participants, HIV negative at RDS.
11253230|NCT02573948|OG000|Outcome|HCV Negative Cohort Participants|HCV negative (at RDS) participants
11253231|NCT02573948|EG000|Reported Event|PWID Cohort|250 participants
11253232|NCT02574078|BG000|Baseline|Group A, Cohort A, Nivo|Nivolumab 240 mg every 2 weeks.
11253233|NCT02574078|BG001|Baseline|Group A, Cohort A, Beva + Nivo|Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
11253234|NCT02574078|BG002|Baseline|Group A, Cohort A, Beva|Bevacizumab 15 mg/kg every 3 weeks.
11253235|NCT02574078|BG003|Baseline|Group A, Cohort B, Nivo|Nivolumab 240 mg every 2 weeks.
11253236|NCT02574078|BG004|Baseline|Group A, Cohort B, Peme + Nivo|Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
11253237|NCT02574078|BG005|Baseline|Group A, Cohort B, Peme|Pemetrexed 500 mg/m^2 every 3 weeks.
11253238|NCT02574078|BG006|Baseline|Group B, Nivo|Nivolumab 240 mg every 2 weeks.
11253239|NCT02574078|BG007|Baseline|Group B, BSC|Best Supportive Care (BSC)
11253240|NCT02574078|BG008|Baseline|Group C, Nivo|Nivolumab 240 mg every 2 weeks.
11253241|NCT02574078|BG009|Baseline|Group C, ICC|Investigator's Choice of Chemotherapy
11253242|NCT02574078|BG010|Baseline|Group D, Nivo + Erlo|Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
11253243|NCT02574078|BG011|Baseline|Group D, Erlo|Erlotinib 150 mg QD.
11253244|NCT02574078|BG012|Baseline|Group E|Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
11253245|NCT02574078|BG013|Baseline|Total|Total of all reporting groups
11253246|NCT02574078|FG000|Participant Flow|Group A, Cohort A, Nivo|Nivolumab 240 mg every 2 weeks.
11253247|NCT02574078|FG001|Participant Flow|Group A, Cohort A, Beva + Nivo|Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
11253248|NCT02574078|FG002|Participant Flow|Group A, Cohort A, Beva|Bevacizumab 15 mg/kg every 3 weeks.
11253249|NCT02574078|FG003|Participant Flow|Group A, Cohort B, Nivo|Nivolumab 240 mg every 2 weeks.
11253250|NCT02574078|FG004|Participant Flow|Group A, Cohort B, Peme + Nivo|Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
11253251|NCT02574078|FG005|Participant Flow|Group A, Cohort B, Peme|Pemetrexed 500 mg/m^2 every 3 weeks.
11253252|NCT02574078|FG006|Participant Flow|Group B, Nivo|Nivolumab 240 mg every 2 weeks.
11253253|NCT02574078|FG007|Participant Flow|Group B, BSC|Best Supportive Care (BSC)
11253254|NCT02574078|FG008|Participant Flow|Group C, Nivo|Nivolumab 240 mg every 2 weeks.
11253255|NCT02574078|FG009|Participant Flow|Group C, ICC|Investigator's Choice of Chemotherapy
11253256|NCT02574078|FG010|Participant Flow|Group D, Nivo + Erlo|Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
11253257|NCT02574078|FG011|Participant Flow|Group D, Erlo|Erlotinib 150 mg QD.
11253258|NCT02574078|FG012|Participant Flow|Group E|Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
11253259|NCT02574078|OG000|Outcome|Group A, Cohort A, Nivo|Nivolumab 240 mg every 2 weeks.
11253260|NCT02574078|OG001|Outcome|Group A, Cohort A, Beva + Nivo|Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
11253261|NCT02574078|OG002|Outcome|Group A, Cohort A, Beva|Bevacizumab 15 mg/kg every 3 weeks.
11253262|NCT02574078|OG003|Outcome|Group A, Cohort B, Nivo|Nivolumab 240 mg every 2 weeks.
11253263|NCT02574078|OG004|Outcome|Group A, Cohort B, Peme + Nivo|Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
11253264|NCT02574078|OG005|Outcome|Group A, Cohort B, Peme|Pemetrexed 500 mg/m^2 every 3 weeks.
11253265|NCT02574078|OG006|Outcome|Group B, Nivo|Nivolumab 240 mg every 2 weeks.
11253266|NCT02574078|OG007|Outcome|Group B, BSC|Best Supportive Care (BSC)
11253267|NCT02574078|OG008|Outcome|Group C, Nivo|Nivolumab 240 mg every 2 weeks.
11253268|NCT02574078|OG009|Outcome|Group C, ICC|Investigator's Choice of Chemotherapy
11253269|NCT02574078|OG010|Outcome|Group D, Nivo + Erlo|Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
11253270|NCT02574078|OG011|Outcome|Group D, Erlo|Erlotinib 150 mg QD.
11253271|NCT02574078|OG000|Outcome|Group E|Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
11253272|NCT02574078|OG012|Outcome|Group E|Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
11253273|NCT02574078|OG000|Outcome|Group D, Nivo + Erlo|Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
11253274|NCT02574078|OG001|Outcome|Group D, Erlo|Erlotinib 150 mg QD.
11253275|NCT02574078|EG000|Reported Event|SUB-STUDY A, COHORT A: NIVOLUMAB 240 MG|Nivolumab 240 mg every 2 weeks.
11253276|NCT02574078|EG001|Reported Event|SUB-STUDY A: BEVACIZUMAB + NIVOLUMAB 5 MG/KG|Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
11253277|NCT02574078|EG002|Reported Event|SUB-STUDY A: BEVACIZUMAB|Bevacizumab 15 mg/kg every 3 weeks.
11253278|NCT02574078|EG003|Reported Event|SUB-STUDY A, COHORT B: NIVOLUMAB 240 MG|Nivolumab 240 mg every 2 weeks.
11253279|NCT02574078|EG004|Reported Event|SUB-STUDY A: PEMETREXED + NIVOLUMAB 5 MG/KG|Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
11253280|NCT02574078|EG005|Reported Event|SUB-STUDY A: PEMETREXED|Pemetrexed 500 mg/m^2 every 3 weeks.
11253281|NCT02574078|EG006|Reported Event|SUB-STUDY B: NIVOLUMAB 240 MG|Nivolumab 240 mg every 2 weeks.
11253282|NCT02574078|EG007|Reported Event|SUB-STUDY B: BEST SUPPORTIVE CARE|Best Supportive Care (BSC)
11253283|NCT02574078|EG008|Reported Event|SUB-STUDY C: NIVOLUMAB 240 MG|Nivolumab 240 mg every 2 weeks.
11253284|NCT02574078|EG009|Reported Event|SUB-STUDY C: INVESTIGATOR'S CHOICE OF CHEMOTHERAPY|Investigator's Choice of Chemotherapy (ICC)
11253285|NCT02574078|EG010|Reported Event|SUB-STUDY D: NIVOLUMAB 240 MG + ERLOTINIB|Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
11253286|NCT02574078|EG011|Reported Event|SUB-STUDY D: ERLOTINIB|Erlotinib 150 mg QD.
11253287|NCT02574078|EG012|Reported Event|SUB-STUDY E: SINGLE ARM: NIVOLUMAB 240 MG + CRIZOTINIB|Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
11253288|NCT02574247|BG000|Baseline|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
11253289|NCT02574247|BG001|Baseline|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
11253290|NCT02574247|BG002|Baseline|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
11253291|NCT02574247|BG003|Baseline|Total|Total of all reporting groups
11253292|NCT02574247|FG000|Participant Flow|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
11253293|NCT02574247|FG001|Participant Flow|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
11253294|NCT02574247|FG002|Participant Flow|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
11253295|NCT02574247|OG000|Outcome|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
11253296|NCT02574247|OG001|Outcome|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
11253297|NCT02574247|OG002|Outcome|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
11253298|NCT02574247|OG000|Outcome|Pooled Participant Data|Baseline data from Training, Control, and Speech Groups pooled together.
11253299|NCT02574247|OG000|Outcome|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) up to 1 year."
11253300|NCT02574247|EG000|Reported Event|Training|"Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.~Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year."
11253301|NCT02574247|EG001|Reported Event|Control|Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.
11253302|NCT02574247|EG002|Reported Event|Speech Group|Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
11253303|NCT02574260|BG000|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
11253304|NCT02574260|FG000|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
11253305|NCT02574260|OG000|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
11253306|NCT02574260|EG000|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
11253307|NCT02574312|BG000|Baseline|RUI (Reuseable Instrumentation)|Patients were operated on using Reusable TKA Instrumentation
11253308|NCT02574312|BG001|Baseline|SUI (Single-Use Instrumentation)|Patients were operated on using Single-Use TKA Instrumentation
11253309|NCT02574312|BG002|Baseline|Total|Total of all reporting groups
11253310|NCT02574312|FG000|Participant Flow|RUI (Reuseable Instrumentation)|Patients were operated on using Reusable TKA Instrumentation
11253311|NCT02574312|FG001|Participant Flow|SUI (Single-Use Instrumentation)|Patients were operated on using Single-Use TKA Instrumentation
11253312|NCT02574312|OG000|Outcome|RUI (Reuseable Instrumentation)|Patients were operated on using Reusable TKA Instrumentation
11253313|NCT02574312|OG001|Outcome|SUI (Single-Use Instrumentation)|Patients were operated on using Single-Use TKA Instrumentation
11253314|NCT02574312|EG000|Reported Event|RUI (Reuseable Instrumentation)|Patients were operated on using Reusable TKA Instrumentation
11253315|NCT02574312|EG001|Reported Event|SUI (Single-Use Instrumentation)|Patients were operated on using Single-Use TKA Instrumentation
11253316|NCT02574520|BG000|Baseline|SABER-Bupivacaine (Part 1)|5 ml once at end of surgery
11253317|NCT02574520|BG001|Baseline|Saline Placebo (Part 1)|5 ml once at end of surgery
11253318|NCT02574520|BG002|Baseline|SABER-Bupivacaine (Part 2)|5 ml once at end of surgery
11253319|NCT02574520|BG003|Baseline|Bupivacaine HCL (Part 2)|0.5%, 15 ml, once at end of surgery
11253320|NCT02574520|BG004|Baseline|Total|Total of all reporting groups
11253321|NCT02574520|FG000|Participant Flow|SABER-Bupivacaine (Part 1)|5 ml once at end of surgery
11253322|NCT02574520|FG001|Participant Flow|Saline Placebo (Part 1)|5 ml once at end of surgery
11253323|NCT02574520|FG002|Participant Flow|SABER-Bupivacaine (Part 2)|5 ml once at end of surgery
11253324|NCT02574520|FG003|Participant Flow|Bupivacaine HCL (Part 2)|0.5%, 15 ml, once at end of surgery
11253325|NCT02574520|OG000|Outcome|Part 2/SABER-Bupivacaine|5 ml once at end of surgery
11253326|NCT02574520|OG001|Outcome|Part 2/Bupivacaine HCl|0.5%, 15 ml, once at end of surgery
11253327|NCT02574520|OG000|Outcome|Part 1 and Part 2: SABER-Bupivacaine|5 ml once at end of surgery
10969900|NCT00908037|FG006|Participant Flow|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11253328|NCT02574520|OG001|Outcome|Part 2: Bupivacaine HCl|0.5%, 15 ml, once at end of surgery
11253329|NCT02574520|EG000|Reported Event|SABER-Bupivacaine (Part 1)|5 ml once at end of surgery
11253330|NCT02574520|EG001|Reported Event|Saline Placebo (Part 1)|5 ml once at end of surgery
11253331|NCT02574520|EG002|Reported Event|SABER-Bupivacaine (Part 2)|5 ml once at end of surgery
11253332|NCT02574520|EG003|Reported Event|Bupivacaine HCL (Part 2)|0.5%, 15 ml, once at end of surgery
11253333|NCT02574598|BG000|Baseline|Docetaxel + MK-3475|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.
11253334|NCT02574598|BG001|Baseline|Docetaxel|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.
11253335|NCT02574598|BG002|Baseline|Total|Total of all reporting groups
11253336|NCT02574598|FG000|Participant Flow|Docetaxel + MK-3475|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.
11253337|NCT02574598|FG001|Participant Flow|Docetaxel|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.
11253338|NCT02574598|OG000|Outcome|Docetaxel + MK-3475|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles MK-3475 (200mg, Day 8, every 3 weeks), followed by maintenance therapy with MK-3475 until disease progression or unacceptable toxicity.
11253339|NCT02574598|OG001|Outcome|Docetaxel|Docetaxel 75 mg/m2 day 1 every 3 weeks for 6 cycles.
11253340|NCT02574598|EG000|Reported Event|Docetaxel + MK-3475|"Docetaxel 75 mg/m2 every 3 weeks until progression of disease~MK-3475 (administered on day 8) 200mg every 3 until progression of disease~MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity.~Docetaxel: Use on both arms as standard of care."
11253341|NCT02574598|EG001|Reported Event|Docetaxel|"Docetaxel 75 mg/m2 every 3 weeks until progression of disease followed by MK-3475 200mg every 3 until progression of disease~MK-3475: The dosing interval of pembrolizumab can be increased in case of toxicity.~Docetaxel: Use on both arms as standard of care."
11253342|NCT02574637|BG000|Baseline|Placebo|Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
11253343|NCT02574637|BG001|Baseline|Brazikumab High Dose|Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11253344|NCT02574637|BG002|Baseline|Brazikumab High-Medium Dose|Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11253345|NCT02574637|BG003|Baseline|Brazikumab Low-Medium Dose|Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11286416|NCT02888093|OG000|Outcome|Absorbable|"Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11286417|NCT02888093|OG001|Outcome|Permanent|"Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11253346|NCT02574637|BG004|Baseline|Brazikumab Low Dose|Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11253347|NCT02574637|BG005|Baseline|Total|Total of all reporting groups
11253348|NCT02574637|FG000|Participant Flow|Double Blind (DB): Placebo|Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
11253349|NCT02574637|FG001|Participant Flow|DB: Brazikumab High Dose|Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks at Weeks 8 and 12 in the induction phase and Weeks 16, 20 and 24 in the maintenance phase.
11253350|NCT02574637|FG002|Participant Flow|DB: Brazikumab High-Medium Dose|Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253351|NCT02574637|FG003|Participant Flow|DB: Brazikumab Low-Medium Dose|Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253352|NCT02574637|FG004|Participant Flow|DB: Brazikumab Low Dose|Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253353|NCT02574637|FG005|Participant Flow|Open-label (OL): Placebo/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.
11253354|NCT02574637|FG006|Participant Flow|OL: Brazikumab High Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.
11253355|NCT02574637|FG007|Participant Flow|OL: Brazikumab High- Medium Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.
11253356|NCT02574637|FG008|Participant Flow|OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.
11253357|NCT02574637|FG009|Participant Flow|OL: Brazikumab Low Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.
11253358|NCT02574637|OG000|Outcome|Placebo|Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
11253359|NCT02574637|OG001|Outcome|Brazikumab High Dose|Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11253360|NCT02574637|OG002|Outcome|Brazikumab High-Medium Dose|Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11253361|NCT02574637|OG003|Outcome|Brazikumab Low-Medium Dose|Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11253362|NCT02574637|OG004|Outcome|Brazikumab Low Dose|Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11253363|NCT02574637|OG000|Outcome|Brazikumab High Dose|Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11286418|NCT02888093|OG000|Outcome|Absorbable|Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)
11286419|NCT02888093|OG001|Outcome|Permanent|Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)
11253364|NCT02574637|OG001|Outcome|Brazikumab High-Medium Dose|Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
11253365|NCT02574637|OG002|Outcome|Brazikumab Low-Medium Dose|Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11253366|NCT02574637|OG003|Outcome|Brazikumab Low Dose|Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
11253367|NCT02574637|EG000|Reported Event|DB: Placebo|Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
11253368|NCT02574637|EG001|Reported Event|DB: Brazikumab High Dose|Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks at Weeks 8 and 12 in the induction phase and Weeks 16, 20 and 24 in the maintenance phase.
11253369|NCT02574637|EG002|Reported Event|DB: Brazikumab High-Medium Dose|Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253370|NCT02574637|EG003|Reported Event|DB: Brazikumab Low-Medium Dose|Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253371|NCT02574637|EG004|Reported Event|DB: Brazikumab Low Dose|Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.
11253372|NCT02574637|EG005|Reported Event|OL: Placebo/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.
11253373|NCT02574637|EG006|Reported Event|OL: Brazikumab High Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.
11253374|NCT02574637|EG007|Reported Event|OL: Brazikumab High-Medium Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.
11253375|NCT02574637|EG008|Reported Event|OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.
11253376|NCT02574637|EG009|Reported Event|OL: Brazikumab Low Dose/Brazikumab 210 mg|Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.
11253377|NCT02574832|BG000|Baseline|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
11286420|NCT02888093|EG000|Reported Event|Absorbable|"Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11286421|NCT02888093|EG001|Reported Event|Permanent|"Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)~Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)"
11286422|NCT02888106|BG000|Baseline|Arm A|PEG IFN alfa-2a 180 µg for 48 weeks
11253378|NCT02574832|FG000|Participant Flow|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
11253379|NCT02574832|OG000|Outcome|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
11253380|NCT02574832|EG000|Reported Event|Spinal Lidocaine Administration|"Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl.~The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.~Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia."
11253381|NCT02574845|BG000|Baseline|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253382|NCT02574845|BG001|Baseline|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253383|NCT02574845|BG002|Baseline|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253384|NCT02574845|BG003|Baseline|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253385|NCT02574845|BG004|Baseline|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253386|NCT02574845|BG005|Baseline|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253387|NCT02574845|BG006|Baseline|Total|Total of all reporting groups
11253388|NCT02574845|FG000|Participant Flow|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11286423|NCT02888106|BG001|Baseline|Arm B|Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11286424|NCT02888106|BG002|Baseline|Arm C|Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11286425|NCT02888106|BG003|Baseline|Arm D|Myrcludex B 2 mg for 48 weeks
11253389|NCT02574845|FG001|Participant Flow|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253390|NCT02574845|FG002|Participant Flow|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253391|NCT02574845|FG003|Participant Flow|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253392|NCT02574845|FG004|Participant Flow|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253393|NCT02574845|FG005|Participant Flow|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
11253394|NCT02574845|OG000|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253395|NCT02574845|OG001|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253396|NCT02574845|OG002|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253397|NCT02574845|OG003|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253398|NCT02574845|OG004|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253399|NCT02574845|OG005|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253400|NCT02574845|EG000|Reported Event|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253401|NCT02574845|EG001|Reported Event|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253402|NCT02574845|EG002|Reported Event|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253403|NCT02574845|EG003|Reported Event|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253404|NCT02574845|EG004|Reported Event|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253405|NCT02574845|EG005|Reported Event|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
11253406|NCT02574858|BG000|Baseline|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
11286426|NCT02888106|BG004|Baseline|Arm E|Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
11286427|NCT02888106|BG005|Baseline|Arm F|Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
11286428|NCT02888106|BG006|Baseline|Total|Total of all reporting groups
11286429|NCT02888106|FG000|Participant Flow|Arm A|PEG IFN alfa-2a 180 µg for 48 weeks
11286430|NCT02888106|FG001|Participant Flow|Arm B|Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11253407|NCT02574858|FG000|Participant Flow|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
11253408|NCT02574858|OG000|Outcome|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
11253409|NCT02574858|EG000|Reported Event|QRH-886620|"The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (~100 µM concentration).~QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5."
11253410|NCT02575079|BG000|Baseline|Parafilm|Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
11253411|NCT02575079|BG001|Baseline|Historical Cohort|Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.
11253412|NCT02575079|BG002|Baseline|Total|Total of all reporting groups
11253413|NCT02575079|FG000|Participant Flow|Parafilm|Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
11253414|NCT02575079|FG001|Participant Flow|Historical Cohort|Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.
11253415|NCT02575079|OG000|Outcome|Parafilm|Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
11253416|NCT02575079|OG001|Outcome|Historical Cohort|Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.
11253417|NCT02575079|EG000|Reported Event|Parafilm|Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
11253418|NCT02575300|BG000|Baseline|Ibrutinib Therapy|"Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)~Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11253419|NCT02575300|FG000|Participant Flow|Ibrutinib Therapy|"Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)~Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11253420|NCT02575300|OG000|Outcome|Ibrutinib Therapy|"Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)~Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11253421|NCT02575300|EG000|Reported Event|Ibrutinib Therapy|"Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)~Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent."
11253422|NCT02575807|BG000|Baseline|Phase 1: CRS-207|"CRS-207 administered in 3-week cycles.~* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle)."
11253423|NCT02575807|BG001|Baseline|Phase 1: CRS-207/IDO 100 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253424|NCT02575807|BG002|Baseline|Phase 1: CRS-207/IDO 300 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253425|NCT02575807|BG003|Baseline|Phase 2: CRS-207/Pembro/IDO|"CRS-207 and pembro administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.~IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle."
11253426|NCT02575807|BG004|Baseline|Phase 2: CRS-207/Pembro|"CRS-207 and pembro administered in 3-week cycles.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles."
11253427|NCT02575807|BG005|Baseline|Total|Total of all reporting groups
11253428|NCT02575807|FG000|Participant Flow|Phase 1: CRS-207|"CRS-207 administered in 3-week cycles.~* CRS-207 (1 x 10e9 colony forming units [CFU]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle)."
11253429|NCT02575807|FG001|Participant Flow|Phase 1: CRS-207/IDO 100 mg|"CRS-207 administered in 3-week cycles, epacadostat (IDO) administered twice daily (BID).~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (100 milligrams [mg]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253430|NCT02575807|FG002|Participant Flow|Phase 1: CRS-207/IDO 300 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253431|NCT02575807|FG003|Participant Flow|Phase 2: CRS-207/Pembro/IDO|"CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.~IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle."
11253432|NCT02575807|FG004|Participant Flow|Phase 2: CRS-207/Pembro|"CRS-207 and pembro administered in 3-week cycles.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles."
11253433|NCT02575807|OG000|Outcome|Phase 1: CRS-207|"CRS-207 administered in 3-week cycles.~* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle)."
11253434|NCT02575807|OG001|Outcome|Phase 1: CRS-207/IDO 100 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253435|NCT02575807|OG002|Outcome|Phase 1: CRS-207/IDO 300 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253436|NCT02575807|OG000|Outcome|Phase 2: CRS-207/Pembro/IDO|"CRS-207 and pembro administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.~IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle."
11253437|NCT02575807|OG001|Outcome|Phase 2: CRS-207/Pembro|"CRS-207 and pembro administered in 3-week cycles.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles."
11253438|NCT02575807|OG003|Outcome|Phase 2: CRS-207/Pembro/IDO|"CRS-207 and pembro administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.~IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle."
11253439|NCT02575807|OG004|Outcome|Phase 2: CRS-207/Pembro|"CRS-207 and pembro administered in 3-week cycles.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles."
11253440|NCT02575807|EG000|Reported Event|Phase 1: CRS-207|"CRS-207 administered in 3-week cycles.~* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle)."
11253441|NCT02575807|EG001|Reported Event|Phase 1: CRS-207/IDO 100 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253442|NCT02575807|EG002|Reported Event|Phase 1: CRS-207/IDO 300 mg|"CRS-207 administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).~IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle."
11253443|NCT02575807|EG003|Reported Event|Phase 2: CRS-207/Pembro/IDO|"CRS-207 and pembro administered in 3-week cycles, IDO administered BID.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.~IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle."
11253444|NCT02575807|EG004|Reported Event|Phase 2: CRS-207/Pembro|"CRS-207 and pembro administered in 3-week cycles.~CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).~Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles."
11253445|NCT02575833|BG000|Baseline|Placebo|Participants randomized to receive a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253446|NCT02575833|BG001|Baseline|Erenumab|Participants randomized to receive a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253447|NCT02575833|BG002|Baseline|Total|Total of all reporting groups
11253448|NCT02575833|FG000|Participant Flow|Placebo|Participants randomized to receive a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253449|NCT02575833|FG001|Participant Flow|Erenumab|Participants randomized to receive a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253450|NCT02575833|OG000|Outcome|Placebo|Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253451|NCT02575833|OG001|Outcome|Erenumab|Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253452|NCT02575833|EG000|Reported Event|Placebo|Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253453|NCT02575833|EG001|Reported Event|Erenumab 140 mg|Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.
11253454|NCT02575911|BG000|Baseline|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
11253455|NCT02575911|FG000|Participant Flow|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
11253456|NCT02575911|OG000|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
11253457|NCT02575911|OG000|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
11253458|NCT02575911|OG001|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
11253459|NCT02575911|OG000|Outcome|Baseline|Prior to LASIK surgery
11253460|NCT02575911|OG001|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
11253461|NCT02575911|OG002|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
11253462|NCT02575911|OG000|Outcome|LenSx - 1 Month Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
11253463|NCT02575911|OG001|Outcome|LenSx - 3 Months Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
11253464|NCT02575911|EG000|Reported Event|Pre-treatment|All who consented to participate in the study prior to the initiation of study treatment
11253465|NCT02575911|EG001|Reported Event|LenSx|All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
11253466|NCT02575950|BG000|Baseline|Total|All participants randomized to treatment
11253467|NCT02575950|FG000|Participant Flow|Cohort 1|Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas (approx. 36 cm2 each) sequentially so that the second and third participants were not dosed until a safety evaluation of the preceding participant had been done. The first participant was dosed for 1 day, the second participant for up to 2 days, and the third participant for up to 3 days.
11253468|NCT02575950|FG001|Participant Flow|Cohort 2|Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
11253469|NCT02575950|FG002|Participant Flow|Cohort 3|Participants received once daily treatment with LEO 43204 gel 0.018 and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
11253470|NCT02575950|FG003|Participant Flow|Cohort 4|Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
11253471|NCT02575950|OG000|Outcome|LEO 43204 0.018%|LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
11253472|NCT02575950|OG001|Outcome|Vehicle|LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
11253473|NCT02575950|OG000|Outcome|LEO 43204 0.018%|LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
11253474|NCT02575950|EG000|Reported Event|Non-cutaneous|Non-cutaneous adverse events
11253475|NCT02575950|EG001|Reported Event|LEO 43204 0.018%|LEO 43204 0.018% gel administered to an acne lesion on either left or right cheek
11253476|NCT02575950|EG002|Reported Event|Vehicle|LEO 43204 vehicle gel administered to an acne lesion on either left or right cheek
11253477|NCT02576041|BG000|Baseline|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
11253478|NCT02576041|FG000|Participant Flow|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
11286431|NCT02888106|FG002|Participant Flow|Arm C|Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11253479|NCT02576041|OG000|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
11253480|NCT02576041|EG000|Reported Event|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
11253481|NCT02576054|BG000|Baseline|V501|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253482|NCT02576054|FG000|Participant Flow|V501|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253483|NCT02576054|OG000|Outcome|V501|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253484|NCT02576054|OG000|Outcome|Participants Aged 9 to 15 Years (PN200)|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253485|NCT02576054|OG001|Outcome|Participants Aged 16 to 26 Years (PN122)|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253486|NCT02576054|EG000|Reported Event|V501|0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
11253487|NCT02576067|BG000|Baseline|Low Dose Methotrexate|Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
11253488|NCT02576067|BG001|Baseline|Placebo|matching placebo
11253489|NCT02576067|BG002|Baseline|Total|Total of all reporting groups
11253490|NCT02576067|FG000|Participant Flow|Low Dose Methotrexate|Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
11253491|NCT02576067|FG001|Participant Flow|Placebo|matching placebo
11253492|NCT02576067|OG000|Outcome|Low Dose Methotrexate|Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
11253493|NCT02576067|OG001|Outcome|Placebo|matching placebo
11253494|NCT02576067|EG000|Reported Event|Low Dose Methotrexate|Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
11253495|NCT02576067|EG001|Reported Event|Placebo|matching placebo
11253496|NCT02576145|BG000|Baseline|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
11253497|NCT02576145|BG001|Baseline|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
11253498|NCT02576145|BG002|Baseline|Total|Total of all reporting groups
11253499|NCT02576145|FG000|Participant Flow|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
11253500|NCT02576145|FG001|Participant Flow|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
11253501|NCT02576145|OG000|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
11253502|NCT02576145|OG001|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
11253503|NCT02576145|EG000|Reported Event|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
11253504|NCT02576145|EG001|Reported Event|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
11253505|NCT02576249|BG000|Baseline|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
11253506|NCT02576249|BG001|Baseline|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
11253507|NCT02576249|BG002|Baseline|Total|Total of all reporting groups
11253508|NCT02576249|FG000|Participant Flow|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
11253509|NCT02576249|FG001|Participant Flow|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
11253510|NCT02576249|OG000|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
11253511|NCT02576249|OG001|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
11253512|NCT02576249|EG000|Reported Event|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
11253513|NCT02576249|EG001|Reported Event|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
11286432|NCT02888106|FG003|Participant Flow|Arm D|Myrcludex B 2 mg for 48 weeks
11286433|NCT02888106|FG004|Participant Flow|Arm E|Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
11253514|NCT02576535|BG000|Baseline|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
11253515|NCT02576535|FG000|Participant Flow|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
11253516|NCT02576535|OG000|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
11253517|NCT02576535|EG000|Reported Event|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
11253518|NCT02576587|BG000|Baseline|Case (Diagnosed With PAF)|"Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.~Cases completed baseline and having matched controls were included in baseline data analysis."
11253519|NCT02576587|BG001|Baseline|Controls|"Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.~Controls completed baseline and having matched cases were included in baseline data analysis."
11253520|NCT02576587|BG002|Baseline|Total|Total of all reporting groups
11253521|NCT02576587|FG000|Participant Flow|Case (Diagnosed With PAF)|"Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.~Cases found to have an apnea hypopnea index >=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.~Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI >=15) will be place on CPAP therapy."
11253522|NCT02576587|FG001|Participant Flow|Controls|Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
11253523|NCT02576587|OG000|Outcome|Case (Diagnosed With PAF)|"Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.~Cases found to have an apnea hypopnea index >=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.~Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI >=15) will be place on CPAP therapy."
11253524|NCT02576587|OG001|Outcome|Controls|Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
11253525|NCT02576587|OG000|Outcome|Case Baseline|Case baseline measurements
11253526|NCT02576587|OG001|Outcome|Case Follow-up|Case follow-up measurements
11253527|NCT02576587|EG000|Reported Event|Case (Diagnosed With PAF)|"Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.~Cases found to have an apnea hypopnea index >=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.~Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI >=15) will be place on CPAP therapy."
11253528|NCT02576587|EG001|Reported Event|Controls|Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
11253529|NCT02576639|BG000|Baseline|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
11253530|NCT02576639|BG001|Baseline|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
11253531|NCT02576639|BG002|Baseline|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
11253532|NCT02576639|BG003|Baseline|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
11253533|NCT02576639|BG004|Baseline|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
11253534|NCT02576639|BG005|Baseline|Total|Total of all reporting groups
11253535|NCT02576639|FG000|Participant Flow|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
11253536|NCT02576639|FG001|Participant Flow|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
11253537|NCT02576639|FG002|Participant Flow|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
11253538|NCT02576639|FG003|Participant Flow|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
11253539|NCT02576639|FG004|Participant Flow|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
11253540|NCT02576639|OG000|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
11253541|NCT02576639|OG001|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
11253542|NCT02576639|OG002|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
11253543|NCT02576639|OG003|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
11253544|NCT02576639|OG004|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
11253545|NCT02576639|OG000|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
11253546|NCT02576639|OG001|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
11253547|NCT02576639|OG002|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
11253548|NCT02576639|OG003|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
11253549|NCT02576639|EG000|Reported Event|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
11253550|NCT02576639|EG001|Reported Event|CNP520 2mg|CNP520 2 mg was taken qd orally for 13 weeks.
11253551|NCT02576639|EG002|Reported Event|CNP520 10mg|CNP520 10 mg was taken qd orally for 13 weeks.
11253552|NCT02576639|EG003|Reported Event|CNP520 35mg|CNP520 35 mg was taken qd orally for 13 weeks.
11253553|NCT02576639|EG004|Reported Event|CNP520 85mg|CNP520 85 mg was taken qd orally for 13 weeks.
11253554|NCT02576652|BG000|Baseline|Osteoarthritis Participants|Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
11253555|NCT02576652|FG000|Participant Flow|Osteoarthritis Participants|Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
11253556|NCT02576652|OG000|Outcome|Osteoarthritis Participants|Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
11253557|NCT02576652|EG000|Reported Event|Total Hip Replacement|Participants previously treated with denosumab and planning to undergo THR received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after the receipt of the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
11253558|NCT02576678|BG000|Baseline|Group 1 Adolescents: Apremilast 20 mg|Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to < 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.
11253559|NCT02576678|BG001|Baseline|Group 1 Adolescents: Apremilast 30 mg|Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253560|NCT02576678|BG002|Baseline|Group 2 Children: Apremilast 20 mg|Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253561|NCT02576678|BG003|Baseline|Total|Total of all reporting groups
11253562|NCT02576678|FG000|Participant Flow|Group 1 Adolescents: Apremilast 20 mg|Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to < 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.
11253563|NCT02576678|FG001|Participant Flow|Group 1 Adolescents: Apremilast 30 mg|Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253564|NCT02576678|FG002|Participant Flow|Group 2 Children: Apremilast 20 mg|Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253565|NCT02576678|OG000|Outcome|Group 1 Adolescents: Apremilast 20 mg|Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to < 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.
11253566|NCT02576678|OG001|Outcome|Group 1 Adolescents: Apremilast 30 mg|Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253567|NCT02576678|OG002|Outcome|Group 2 Children: Apremilast 20 mg|Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253568|NCT02576678|EG000|Reported Event|Group 1 Adolescents: Apremilast 20 mg|Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to < 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.
11253569|NCT02576678|EG001|Reported Event|Group 1 Adolescents: Apremilast 30 mg|Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253570|NCT02576678|EG002|Reported Event|Group 2 Children: Apremilast 20 mg|Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
11253571|NCT02576899|BG000|Baseline|ACT-PT|Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
11253572|NCT02576899|BG001|Baseline|Freedom From Smoking|"The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.~Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs."
11253573|NCT02576899|BG002|Baseline|Total|Total of all reporting groups
11286434|NCT02888106|FG005|Participant Flow|Arm F|Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
11286435|NCT02888106|OG000|Outcome|Arm A|PEG IFN alfa-2a 180 µg for 48 weeks
11286436|NCT02888106|OG001|Outcome|Arm B|Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11286437|NCT02888106|OG002|Outcome|Arm C|Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11286438|NCT02888106|OG003|Outcome|Arm D|Myrcludex B 2 mg for 48 weeks
11253574|NCT02576899|FG000|Participant Flow|Stage 1b Study of ACT-PT vs. FFS|"This study involves a randomized clinical trial study of 50 Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: 10 individual sessions of ACT-PT (n= 25) versus 10 individual sessions of the American Lung Association's Freedom From Smoking Program [FFS] (n=25). This study has two primary aims: 1) Evaluate the relative feasibility and acceptability of the two interventions (including ease of recruitment, randomization proportion, staff and Veteran acceptance of the treatment, retention rates, treatment adherence, fidelity, ease of the assessment process), and 2) Evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use, PTSD symptoms, health-related quality of life, and functional impairment.~Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence."
11253575|NCT02576899|FG001|Participant Flow|Freedom From Smoking|"The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.~Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs."
11253576|NCT02576899|OG000|Outcome|ACT-PT|Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence.
11253577|NCT02576899|OG001|Outcome|Freedom From Smoking|"The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.~Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs."
11253578|NCT02576899|OG000|Outcome|ACT-PT|Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values.
11253579|NCT02576899|EG000|Reported Event|ACT-PT|Acceptance and Commitment Therapy for PTSD and Tobacco Use: ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values.
11253580|NCT02576899|EG001|Reported Event|Freedom From Smoking|"The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.~Freedom From Smoking: The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs."
11253581|NCT02576938|BG000|Baseline|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
11253582|NCT02576938|BG001|Baseline|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253583|NCT02576938|BG002|Baseline|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253584|NCT02576938|BG003|Baseline|Total|Total of all reporting groups
11253585|NCT02576938|FG000|Participant Flow|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253586|NCT02576938|FG001|Participant Flow|2 mg Baricitinib|2 milligram (mg) Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253587|NCT02576938|FG002|Participant Flow|4 mg Baricitinib|4 mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253588|NCT02576938|OG000|Outcome|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks Triamcinolone 0.1% applied topically also permitted throughout study.
11253589|NCT02576938|OG001|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253590|NCT02576938|OG002|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253591|NCT02576938|OG000|Outcome|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253592|NCT02576938|OG001|Outcome|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253593|NCT02576938|EG000|Reported Event|Placebo|Placebo administered orally (PO) once daily (QD), for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253594|NCT02576938|EG001|Reported Event|2 mg Baricitinib|2mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11286439|NCT02888106|OG004|Outcome|Arm E|Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
11253595|NCT02576938|EG002|Reported Event|4mg Baricitinib|4mg Baricitinib administered PO QD for 16 weeks. Triamcinolone 0.1% applied topically also permitted throughout study.
11253596|NCT02576951|BG000|Baseline|240 mg Galcanezumab Solution - Part A|Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253597|NCT02576951|BG001|Baseline|Placebo - Part A|Participants received placebo by subcutaneous injection.
11253598|NCT02576951|BG002|Baseline|300 mg Galcanezumab Lyophilized - Part B|Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
11253599|NCT02576951|BG003|Baseline|300 mg Galcanezumab Solution - Part B|Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253600|NCT02576951|BG004|Baseline|Total|Total of all reporting groups
11253601|NCT02576951|FG000|Participant Flow|240 mg Galcanezumab Solution - Part A|Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection.
11253602|NCT02576951|FG001|Participant Flow|Placebo - Part A|Participants received placebo by subcutaneous injection.
11253603|NCT02576951|FG002|Participant Flow|300 mg Galcanezumab Lyophilized - Part B|Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
11253604|NCT02576951|FG003|Participant Flow|300 mg Galcanezumab Solution - Part B|Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection
11253605|NCT02576951|OG000|Outcome|240 mg Galcanezumab - Part A|Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253606|NCT02576951|OG001|Outcome|Placebo - Part A|Participants received placebo by subcutaneous injection.
11253607|NCT02576951|OG000|Outcome|300mg Galcanezumab Solution - Part B|Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253608|NCT02576951|OG001|Outcome|300 mg Galcanezumab Lyophilized - Part B|Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
11253609|NCT02576951|OG000|Outcome|300 mg Galcanezumab Solution - Part B|Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253610|NCT02576951|OG000|Outcome|240 mg Galcanezumab - Part A|Participants received 240mg Galcanezumab as a solution formulation by subcutaneous injection.
11253611|NCT02576951|EG000|Reported Event|Galcanezumab 240 mg - Part A|Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253612|NCT02576951|EG001|Reported Event|Placebo - Part A|Participants received placebo by subcutaneous injection.
11253613|NCT02576951|EG002|Reported Event|Galcanezumab 300 mg Lyophilized - Part B|Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
11253614|NCT02576951|EG003|Reported Event|Galcanezumab 300 mg Solution - Part B|Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
11253615|NCT02576977|BG000|Baseline|Pembrolizumab+Pomalidomide+Dexamethasone|Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253616|NCT02576977|BG001|Baseline|Standard of Care (SOC) Pomalidomide+Dexamethasone|Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253617|NCT02576977|BG002|Baseline|Total|Total of all reporting groups
11253618|NCT02576977|FG000|Participant Flow|Pembrolizumab+Pomalidomide+Dexamethasone|Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253619|NCT02576977|FG001|Participant Flow|Standard of Care (SOC) Pomalidomide+Dexamethasone|Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253620|NCT02576977|OG000|Outcome|Pembrolizumab+Pomalidomide+Dexamethasone|Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253621|NCT02576977|OG001|Outcome|Standard of Care (SOC) Pomalidomide+Dexamethasone|Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253622|NCT02576977|EG000|Reported Event|Pembrolizumab+Pomalidomide+Dexamethasone|Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253623|NCT02576977|EG001|Reported Event|Standard of Care (SOC) Pomalidomide+Dexamethasone|Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
11253624|NCT02576990|BG000|Baseline|Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)|Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253625|NCT02576990|BG001|Baseline|Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)|Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253626|NCT02576990|BG002|Baseline|Total|Total of all reporting groups
11253627|NCT02576990|FG000|Participant Flow|Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)|Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253628|NCT02576990|FG001|Participant Flow|Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)|Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253629|NCT02576990|OG000|Outcome|Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)|Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11286440|NCT02888106|OG005|Outcome|Arm F|Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
11253630|NCT02576990|OG001|Outcome|Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)|Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253631|NCT02576990|EG000|Reported Event|Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)|Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253632|NCT02576990|EG001|Reported Event|Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)|Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
11253633|NCT02577003|BG000|Baseline|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253634|NCT02577003|BG001|Baseline|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253635|NCT02577003|BG002|Baseline|Total|Total of all reporting groups
11253636|NCT02577003|FG000|Participant Flow|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253637|NCT02577003|FG001|Participant Flow|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253638|NCT02577003|OG000|Outcome|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253639|NCT02577003|OG001|Outcome|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253640|NCT02577003|EG000|Reported Event|Ipragliflozin + Sitagliptin|Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253641|NCT02577003|EG001|Reported Event|Placebo + Sitagliptin|Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
11253642|NCT02577016|BG000|Baseline|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253643|NCT02577016|BG001|Baseline|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253644|NCT02577016|BG002|Baseline|Total|Total of all reporting groups
11253645|NCT02577016|FG000|Participant Flow|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253646|NCT02577016|FG001|Participant Flow|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253647|NCT02577016|OG000|Outcome|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253648|NCT02577016|OG001|Outcome|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253649|NCT02577016|EG000|Reported Event|Sitagliptin + Ipragliflozin|Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253650|NCT02577016|EG001|Reported Event|Placebo + Ipragliflozin|Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
11253651|NCT02577029|BG000|Baseline|Cohort 1|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253652|NCT02577029|BG001|Baseline|Cohort 2|Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253653|NCT02577029|BG002|Baseline|Cohort 3|Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253654|NCT02577029|BG003|Baseline|Cohort 4|Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253655|NCT02577029|BG004|Baseline|Cohort 5|Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253656|NCT02577029|BG005|Baseline|Cohort 6|Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253657|NCT02577029|BG006|Baseline|Cohort 7|Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
11253658|NCT02577029|BG007|Baseline|Cohort 8|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253659|NCT02577029|BG008|Baseline|Total|Total of all reporting groups
11253660|NCT02577029|FG000|Participant Flow|Cohort 1|"Treatment-naïve, hepatitis B e antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous [IV]) every 4 weeks for 48 weeks (13 doses)."
11253661|NCT02577029|FG001|Participant Flow|Cohort 2|Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered entecavir (ETV) or tenofovir (TDF) for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87.
11253662|NCT02577029|FG002|Participant Flow|Cohort 3|Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253663|NCT02577029|FG003|Participant Flow|Cohort 4|Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253664|NCT02577029|FG004|Participant Flow|Cohort 5|Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253665|NCT02577029|FG005|Participant Flow|Cohort 6|Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253666|NCT02577029|FG006|Participant Flow|Cohort 7|Treatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
11253667|NCT02577029|FG007|Participant Flow|Cohort 8|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253668|NCT02577029|OG000|Outcome|Cohort 1|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253669|NCT02577029|OG001|Outcome|Cohort 2|Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253670|NCT02577029|OG002|Outcome|Cohort 3|Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253671|NCT02577029|OG003|Outcome|Cohort 4|Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253672|NCT02577029|OG004|Outcome|Cohort 5|Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253673|NCT02577029|OG005|Outcome|Cohort 6|Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253674|NCT02577029|OG006|Outcome|Cohort 7|Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
11253675|NCT02577029|OG007|Outcome|Cohort 8|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253676|NCT02577029|EG000|Reported Event|Cohort 1|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253677|NCT02577029|EG001|Reported Event|Cohort 2|Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253678|NCT02577029|EG002|Reported Event|Cohort 3|Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253679|NCT02577029|EG003|Reported Event|Cohort 4|Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253680|NCT02577029|EG004|Reported Event|Cohort 5|Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253681|NCT02577029|EG005|Reported Event|Cohort 6|Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
11253682|NCT02577029|EG006|Reported Event|Cohort 7|Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
11253683|NCT02577029|EG007|Reported Event|Cohort 8|Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
11253684|NCT02577042|BG000|Baseline|Raltegravir + Atorvastatin|"Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks~Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253685|NCT02577042|BG001|Baseline|PI-based Regimen + Atorvastatin|"Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks.~PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253686|NCT02577042|BG002|Baseline|Total|Total of all reporting groups
11253687|NCT02577042|FG000|Participant Flow|Raltegravir + Atorvastatin|"Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks~Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253688|NCT02577042|FG001|Participant Flow|PI-based Regimen + Atorvastatin|"Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks.~PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253689|NCT02577042|OG000|Outcome|Raltegravir + Atorvastatin|"Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks~Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253690|NCT02577042|OG001|Outcome|PI-based Regimen + Atorvastatin|"Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks.~PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253691|NCT02577042|OG000|Outcome|Raltegravir + Atorvastatin|"Switching the PI by raltegravir, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks~Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253692|NCT02577042|EG000|Reported Event|Raltegravir + Atorvastatin|"Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks~Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253693|NCT02577042|EG001|Reported Event|PI-based Regimen + Atorvastatin|"Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks.~PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.~Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks"
11253694|NCT02577107|BG000|Baseline|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
11253695|NCT02577107|BG001|Baseline|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
11253696|NCT02577107|BG002|Baseline|Total|Total of all reporting groups
11253697|NCT02577107|FG000|Participant Flow|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
11253698|NCT02577107|FG001|Participant Flow|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
11253699|NCT02577107|OG000|Outcome|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
11253700|NCT02577107|OG001|Outcome|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
11253701|NCT02577107|EG000|Reported Event|Ranibizumab 0.5 mg|Three monthly injections of 0.5mg Ranibizumab
11253702|NCT02577107|EG001|Reported Event|Conbercept 0.5 mg|Three monthly injections of 0.5mg Conbercept
11253703|NCT02577146|BG000|Baseline|Study Ultrasound|"Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention.~renal and bladder ultrasound with ureteral jet assessment: The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side."
11286441|NCT02888106|OG000|Outcome|Arm A|"PEG IFN alfa-2a 180 µg for 48 weeks~PEG IFN alfa-2a: solution for subcutaneous injection, once per week"
11286442|NCT02888106|OG001|Outcome|Arm B|"Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks~Myrcludex B: Lyophilised powder for solution for subcutaneous injection~PEG IFN alfa-2a: solution for subcutaneous injection, once per week"
11253704|NCT02577146|FG000|Participant Flow|Study Ultrasound|"Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention.~renal and bladder ultrasound with ureteral jet assessment: The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side."
11253705|NCT02577146|OG000|Outcome|Study Ultrasound|"Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention.~renal and bladder ultrasound with ureteral jet assessment: The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side."
11253706|NCT02577146|EG000|Reported Event|Study Ultrasound|"Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention.~renal and bladder ultrasound with ureteral jet assessment: The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side."
11253707|NCT02577315|BG000|Baseline|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
11253708|NCT02577315|BG001|Baseline|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
11253709|NCT02577315|BG002|Baseline|Total|Total of all reporting groups
11253710|NCT02577315|FG000|Participant Flow|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
11253711|NCT02577315|FG001|Participant Flow|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
11253712|NCT02577315|OG000|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
11253713|NCT02577315|OG001|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
11253714|NCT02577315|EG000|Reported Event|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
11253715|NCT02577315|EG001|Reported Event|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
11253716|NCT02577445|BG000|Baseline|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
11253717|NCT02577445|BG001|Baseline|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
11253718|NCT02577445|BG002|Baseline|Total|Total of all reporting groups
11286443|NCT02888106|OG002|Outcome|Arm C|"Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks~Myrcludex B: Lyophilised powder for solution for subcutaneous injection~PEG IFN alfa-2a: solution for subcutaneous injection, once per week"
11253719|NCT02577445|FG000|Participant Flow|CSA Patients NOT Implanted With remedē System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
11253720|NCT02577445|FG001|Participant Flow|CSA Patients With remedē System|"For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.~Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits.~Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up.~Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:"
11253721|NCT02577445|OG000|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
11253722|NCT02577445|OG000|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
11253723|NCT02577445|OG001|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
11253724|NCT02577445|EG000|Reported Event|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
11253725|NCT02577445|EG001|Reported Event|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
11253726|NCT02577510|BG000|Baseline|All Participants|
11253727|NCT02577510|FG000|Participant Flow|Nerve Stimulation- Xylocaine Injection|"Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.~Nerve Injection- Nerve Stimulator: For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior"
11253728|NCT02577510|FG001|Participant Flow|Ultrasound Guided Xylocaine Injection|Nerve Injection - Ultrasound: For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced unt
11253729|NCT02577510|OG000|Outcome|Nerve Stimulation|
11253730|NCT02577510|OG001|Outcome|Ultrasound|
11253731|NCT02577510|OG000|Outcome|Nerve|
11253732|NCT02577510|OG000|Outcome|Nerve Stimulation- Xylocaine Injection|"Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.~Nerve Injection- Nerve Stimulator: For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior"
11253733|NCT02577510|OG001|Outcome|Ultrasound Guided Xylocaine Injection|Nerve Injection - Ultrasound: For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced unt
11253734|NCT02577510|EG000|Reported Event|Ultrasound Guided Xylocaine Injection|Adverse event collected for this side with this intervention.
11253735|NCT02577510|EG001|Reported Event|Nerve Stimulation Guided Xylocaine Injection|Adverse event collected for this side with this intervention.
11286444|NCT02888106|OG003|Outcome|Arm D|"Myrcludex B 2 mg for 48 weeks~Myrcludex B: Lyophilised powder for solution for subcutaneous injection"
11286445|NCT02888106|OG004|Outcome|Arm E|"Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks~Myrcludex B: Lyophilised powder for solution for subcutaneous injection~PEG IFN alfa-2a: solution for subcutaneous injection, once per week"
11286446|NCT02888106|OG005|Outcome|Arm F|"Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks~Myrcludex B: Lyophilised powder for solution for subcutaneous injection~Tenofovir: Film-coated tablets, 300 mg, per os, once daily"
11286447|NCT02888106|EG000|Reported Event|Arm A|PEG IFN alfa-2a 180 µg for 48 weeks
11253736|NCT02577601|BG000|Baseline|All Cycles|"During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 1: Ulipristal Acetate~The month following this first treatment month (washout-cycle),there will be no study visits during this menstrual cycle but there will be contact with study staff (1 or 2 times) by telephone or email to discuss any health changes that are experiencing.~During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 3: Ulipristal Acetate and Levonorgestrel (LNG)/Ethinyl estradiol birth control pill"
11253737|NCT02577601|FG000|Participant Flow|Treatment Cycles|"UPA only: During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 1: Ulipristal Acetate~UPA+COC: During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 3: Ulipristal Acetate and Levonorgestrel (LNG)/Ethinyl estradiol birth control pill"
11253738|NCT02577601|OG000|Outcome|UPA Only|"During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.~Ulipristal Acetate"
11253739|NCT02577601|OG001|Outcome|UPA + COC|"During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.~Ulipristal Acetate~Levonorgestrel (LNG)/Ethinyl estradiol birth control pill"
11253740|NCT02577601|EG000|Reported Event|UPA Only|"During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.~Ulipristal Acetate"
11253741|NCT02577601|EG001|Reported Event|Washout Cycle|The month following this first treatment month (washout-cycle),there will be no study visits during this menstrual cycle but there will be contact with study staff (1 or 2 times) by telephone or email to discuss any health changes that are experiencing.
11253742|NCT02577601|EG002|Reported Event|UPA + COC|"During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.~Ulipristal Acetate~Levonorgestrel (LNG)/Ethinyl estradiol birth control pill"
11253743|NCT02577640|BG000|Baseline|Dose Escalation Group 1|1 slice bread per day for 1 week
11253744|NCT02577640|BG001|Baseline|Dose Escalation Group 2|2 slices bread per day for 1 week
11253745|NCT02577640|BG002|Baseline|Dose Escalation Group 3|3 slices bread per day for 1 week
11253746|NCT02577640|BG003|Baseline|Maximally Tolerated Dose|maximally tolerated dose for 4 weeks
11253747|NCT02577640|BG004|Baseline|Total|Total of all reporting groups
11253748|NCT02577640|FG000|Participant Flow|Dose Escalation Group 1|DE group at 1 slice of bread per day.
11253749|NCT02577640|FG001|Participant Flow|Dose Escalation Group 2|DE group at 2 slices of bread per day
11253750|NCT02577640|FG002|Participant Flow|Dose Escalation Group 3|DE group at 3 slices of bread per day
11253751|NCT02577640|FG003|Participant Flow|Maximally Tolerated Dose|maximally tolerated dose of bread for 4 week period
11253752|NCT02577640|OG000|Outcome|Dose Escalation Group 1|1 slice bread per day
11253753|NCT02577640|OG001|Outcome|Dose Escalation Group 2|2 slices per day
11253754|NCT02577640|OG002|Outcome|Dose Escalation Group 3|3 slices per day
11253755|NCT02577640|OG003|Outcome|Maximally Tolerated Dose Group|maximally tolerated dose (3 slices/day)
11253756|NCT02577640|OG000|Outcome|Dose Escalation (DE) Phase|Data for each of the 3 doses were examined collectively.
11253757|NCT02577640|OG001|Outcome|Maximum Tolerated Dose (MTD) Phase|Actual data for subjects who completed MTD phase over 4 weeks.
11253758|NCT02577640|EG000|Reported Event|Dose Escalation Group 1|1 slice per day
11253759|NCT02577640|EG001|Reported Event|Dose Escalation Group 2|2 slices per day
11253760|NCT02577640|EG002|Reported Event|Dose Escalation Group 3|3 slices per day
11253761|NCT02577640|EG003|Reported Event|Maximally Tolerated Dose|an extended exposure to the maximally tolerated dose of 3 slices per day.
11253762|NCT02577718|BG000|Baseline|NiCE Lock|
11253763|NCT02577718|FG000|Participant Flow|NiCE Lock|
11253764|NCT02577718|OG000|Outcome|NiCE Lock|All patients who received at least one dose
11253765|NCT02577718|OG000|Outcome|NiCE Lock|Days when patients received NiCE Lock
11253766|NCT02577718|OG001|Outcome|Off NiCE Lock|Days patients did not receive NiCE Lock
11253767|NCT02577718|EG000|Reported Event|NiCE Lock|Patients had days they received NiCE Lock and days they did not receive NiCE Lock (off-Lock days). NiCE Lock was a combination of three different agents so combined results are presented. Most patients received NiCE Lock with Nitroglycerin 30 μg/ml.
11253768|NCT02577822|BG000|Baseline|Short Stem Group|"Short femoral stem~Taperloc short length stem"
11253769|NCT02577822|BG001|Baseline|Long Stem Group|"standard-length stem~Taperloc standard length stem"
11253770|NCT02577822|BG002|Baseline|Total|Total of all reporting groups
11253771|NCT02577822|FG000|Participant Flow|Short Stem Group|"Short femoral stem~Taperloc short length stem"
11253772|NCT02577822|FG001|Participant Flow|Long Stem Group|"standard-length stem~Taperloc standard length stem"
11253773|NCT02577822|OG000|Outcome|Short Stem Group|"Short femoral stem~Taperloc short length stem"
11253774|NCT02577822|OG001|Outcome|Long Stem Group|"standard-length stem~Taperloc standard length stem"
11253775|NCT02577822|EG000|Reported Event|Short Stem Group|"Short femoral stem~Taperloc short length stem"
11253776|NCT02577822|EG001|Reported Event|Long Stem Group|"standard-length stem~Taperloc standard length stem"
11253777|NCT02577887|BG000|Baseline|All Consented Patients|Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
11253778|NCT02577887|FG000|Participant Flow|All Consented Patients|Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
11253779|NCT02577887|OG000|Outcome|All Consented Patients|Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
11253780|NCT02577887|EG000|Reported Event|All Consented Patients|Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
11253781|NCT02577900|BG000|Baseline|Acticoat Absorbent|"Apply Acticoat absorbent onto the ulcer~Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval"
11253782|NCT02577900|BG001|Baseline|Honey Gel Sheet|"Apply Honey gel sheet onto the ulcer~Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval"
11253783|NCT02577900|BG002|Baseline|Jelonet|"Apply Jelonet onto the ulcer~Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval"
11253784|NCT02577900|BG003|Baseline|Total|Total of all reporting groups
11253785|NCT02577900|FG000|Participant Flow|Acticoat Absorbent|"Apply Acticoat absorbent onto the ulcer~Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval"
11253786|NCT02577900|FG001|Participant Flow|Honey Gel Sheet|"Apply Honey gel sheet onto the ulcer~Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval"
11253787|NCT02577900|FG002|Participant Flow|Jelonet|"Apply Jelonet onto the ulcer~Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval"
11253788|NCT02577900|OG000|Outcome|Acticoat Absorbent|"Apply Acticoat absorbent onto the ulcer~Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval"
11253789|NCT02577900|OG001|Outcome|Honey Gel Sheet|"Apply Honey gel sheet onto the ulcer~Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval"
11253790|NCT02577900|OG002|Outcome|Jelonet|"Apply Jelonet onto the ulcer~Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval"
11253791|NCT02577900|EG000|Reported Event|Acticoat Absorbent|"Apply Acticoat absorbent onto the ulcer~Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval"
11253792|NCT02577900|EG001|Reported Event|Honey Gel Sheet|"Apply Honey gel sheet onto the ulcer~Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval"
11253793|NCT02577900|EG002|Reported Event|Jelonet|"Apply Jelonet onto the ulcer~Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval"
11253794|NCT02577978|BG000|Baseline|Medacta Sphere|"Ball-and-socket~Medacta GMK Sphere prosthesis"
11253795|NCT02577978|BG001|Baseline|Medacta PS|"Cam-and-post~Medacta GMK posterior stabilized prosthesis"
11253796|NCT02577978|BG002|Baseline|Total|Total of all reporting groups
11253797|NCT02577978|FG000|Participant Flow|Medacta Sphere|"Ball-and-socket~Medacta GMK Sphere prosthesis"
11253798|NCT02577978|FG001|Participant Flow|Medacta PS|"Cam-and-post~Medacta GMK posterior stabilized prosthesis"
11253799|NCT02577978|OG000|Outcome|Medacta Sphere|"Ball-and-socket~Medacta GMK Sphere prosthesis"
11253800|NCT02577978|OG001|Outcome|Medacta PS|"Cam-and-post~Medacta GMK posterior stabilized prosthesis"
11253801|NCT02577978|EG000|Reported Event|Medacta Sphere|"Ball-and-socket~Medacta GMK Sphere prosthesis"
11253802|NCT02577978|EG001|Reported Event|Medacta PS|"Cam-and-post~Medacta GMK posterior stabilized prosthesis"
11253803|NCT02577991|BG000|Baseline|Control Group|No steroid
11253804|NCT02577991|BG001|Baseline|IV Steroid|"10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate~Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate"
11253805|NCT02577991|BG002|Baseline|Local Steroid|"40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate~Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate"
11253806|NCT02577991|BG003|Baseline|Total|Total of all reporting groups
11253807|NCT02577991|FG000|Participant Flow|Control Group|No steroid
11253808|NCT02577991|FG001|Participant Flow|IV Steroid|"10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate~Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate"
11253809|NCT02577991|FG002|Participant Flow|Local Steroid|"40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate~Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate"
11253810|NCT02577991|OG000|Outcome|Control Group|No steroid
11253811|NCT02577991|OG001|Outcome|IV Steroid|"10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate~Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate"
11253812|NCT02577991|OG002|Outcome|Local Steroid|"40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate~Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate"
11253813|NCT02577991|EG000|Reported Event|Control Group|No steroid
11253814|NCT02577991|EG001|Reported Event|IV Steroid|"10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate~Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate"
11253815|NCT02577991|EG002|Reported Event|Local Steroid|"40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate~Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate"
11253816|NCT02578186|BG000|Baseline|Entire Study Population|Entire Study Population Includes groups that received Placebo and Drug First
11286448|NCT02888106|EG001|Reported Event|Arm B|Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11286449|NCT02888106|EG002|Reported Event|Arm C|Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
11253817|NCT02578186|FG000|Participant Flow|Diphenhydramine Hydrochloride, Then Placebo|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: DPH (50 mg) once a day at bedtime in first intervention period and Placebo once a day at bedtime for the second intervention period (after 5 day washout period)."
11253818|NCT02578186|FG001|Participant Flow|Placebo, Then Diphenhydramine Hydrochloride|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: Placebo once a day at bedtime in first intervention period and DPH (50 mg) once a day at bedtime for the second intervention period (after 5 day washout period)."
11253819|NCT02578186|OG000|Outcome|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
11253820|NCT02578186|OG001|Outcome|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
11253821|NCT02578186|EG000|Reported Event|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
11253822|NCT02578186|EG001|Reported Event|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
11253823|NCT02578199|BG000|Baseline|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
11253824|NCT02578199|FG000|Participant Flow|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
11253825|NCT02578199|OG000|Outcome|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
11253826|NCT02578199|EG000|Reported Event|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.~motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
11253827|NCT02578238|BG000|Baseline|Participants With Pediatric Crohn's Disease (CD)|Participants with pediatric CD prescribed Humira® by their treating physician.
11253828|NCT02578238|FG000|Participant Flow|Participants With Pediatric Crohn's Disease (CD)|Participants with pediatric CD prescribed Humira® by their treating physician.
11253829|NCT02578238|OG000|Outcome|Participants With Pediatric Crohn's Disease (CD)|Participants with pediatric CD prescribed Humira® by their treating physician.
11253830|NCT02578238|EG000|Reported Event|Participants With Pediatric CD|Participants with pediatric CD prescribed Humira® by their treating physician.
11253831|NCT02578316|BG000|Baseline|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11253832|NCT02578316|FG000|Participant Flow|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
11253833|NCT02578316|OG000|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11286450|NCT02888106|EG003|Reported Event|Arm D|Myrcludex B 2 mg for 48 weeks
11286451|NCT02888106|EG004|Reported Event|Arm E|Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
11286452|NCT02888106|EG005|Reported Event|Arm F|Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
11286453|NCT02888171|BG000|Baseline|Ferric Citrate|"Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.~ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals."
11253834|NCT02578316|OG001|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11253835|NCT02578316|OG001|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11253836|NCT02578316|OG000|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11253837|NCT02578316|OG000|Outcome|14C^Lenvatinib/Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
11253838|NCT02578316|EG000|Reported Event|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.~Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
11253839|NCT02578706|BG000|Baseline|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253840|NCT02578706|BG001|Baseline|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253841|NCT02578706|BG002|Baseline|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253842|NCT02578706|BG003|Baseline|Total|Total of all reporting groups
11253843|NCT02578706|FG000|Participant Flow|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253844|NCT02578706|FG001|Participant Flow|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253845|NCT02578706|FG002|Participant Flow|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253846|NCT02578706|OG000|Outcome|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253847|NCT02578706|OG001|Outcome|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253848|NCT02578706|OG002|Outcome|Placebo Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253849|NCT02578706|EG000|Reported Event|Aspirin and Placebo|At week 0, participants will be administered aspirin 81mg (one tablet) and placebo for clopidogrel 75 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253850|NCT02578706|EG001|Reported Event|Clopidogrel and Placebo|At week 0, participants will be administered clopidogrel 75 mg (one tablet) and placebo for aspirin 81 mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253851|NCT02578706|EG002|Reported Event|Placebos Only|At week 0, participants will be administered placebo for aspirin 81 mg (one tablet) and placebo for clopidogrel 75mg (one tablet) once daily. At week 24, participants will stop both study product tablets.
11253852|NCT02578745|BG000|Baseline|Prophylactic NPWT|"Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.~Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface."
11253853|NCT02578745|BG001|Baseline|Standard Dressing|"Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.~Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape."
11253854|NCT02578745|BG002|Baseline|Total|Total of all reporting groups
11253855|NCT02578745|FG000|Participant Flow|Prophylactic NPWT|"Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient was in the hospital to confirm that it wass functioning well. The device will be removed prior to discharge, typically on postoperative day 4.~Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface."
11253856|NCT02578745|FG001|Participant Flow|Standard Dressing|"Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.~Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape."
11253857|NCT02578745|OG000|Outcome|Prophylactic Negative Pressure Wound Therapy (NPWT)|"Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.~Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface."
11253858|NCT02578745|OG001|Outcome|Standard Dressing|"Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.~Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape."
11253859|NCT02578745|OG000|Outcome|Prophylactic NPWT|"Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient was in the hospital to confirm that it wass functioning well. The device will be removed prior to discharge, typically on postoperative day 4.~Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface."
11253860|NCT02578745|EG000|Reported Event|Prophylactic NPWT|"Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient was in the hospital to confirm that it wass functioning well. The device will be removed prior to discharge, typically on postoperative day 4.~Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface."
11253861|NCT02578745|EG001|Reported Event|Standard Dressing|"Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.~Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape."
11253862|NCT02578862|BG000|Baseline|Total Intravenous|"Intravenous propofol for maintenance of anesthesia~Propofol"
11253863|NCT02578862|BG001|Baseline|Inhaled Anesthetic|"Inhaled volatile anesthetic for maintenance of anesthesia~Sevoflurane"
11253864|NCT02578862|BG002|Baseline|Total|Total of all reporting groups
11253865|NCT02578862|FG000|Participant Flow|Total Intravenous|"Intravenous propofol for maintenance of anesthesia~Propofol"
11253866|NCT02578862|FG001|Participant Flow|Inhaled Anesthetic|"Inhaled volatile anesthetic for maintenance of anesthesia~Sevoflurane"
11253867|NCT02578862|OG000|Outcome|Total Intravenous|"Intravenous propofol for maintenance of anesthesia~Propofol"
11253868|NCT02578862|OG001|Outcome|Inhaled Anesthetic|"Inhaled volatile anesthetic for maintenance of anesthesia~Sevoflurane"
11253869|NCT02578862|EG000|Reported Event|Total Intravenous|"Intravenous propofol for maintenance of anesthesia~Propofol"
11253870|NCT02578862|EG001|Reported Event|Inhaled Anesthetic|"Inhaled volatile anesthetic for maintenance of anesthesia~Sevoflurane"
11253871|NCT02578901|BG000|Baseline|Tranexamic Acid (TXA)|"IV or PO administered after meeting inclusion/exclusion criteria~Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered"
11253872|NCT02578901|BG001|Baseline|Placebo|"IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria~Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered"
11253873|NCT02578901|BG002|Baseline|Total|Total of all reporting groups
11253874|NCT02578901|FG000|Participant Flow|Tranexamic Acid (TXA)|"IV or PO administered after meeting inclusion/exclusion criteria~Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered"
11253875|NCT02578901|FG001|Participant Flow|Placebo|"IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria~Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered"
11253876|NCT02578901|OG000|Outcome|Tranexamic Acid (TXA)|"IV or PO administered after meeting inclusion/exclusion criteria~Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered"
11253877|NCT02578901|OG001|Outcome|Placebo|"IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria~Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered"
11253878|NCT02578901|EG000|Reported Event|Tranexamic Acid (TXA)|"IV or PO administered after meeting inclusion/exclusion criteria~Tranexamic Acid: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered"
11253879|NCT02578901|EG001|Reported Event|Placebo|"IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria~Placebo: Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered"
11253880|NCT02578940|BG000|Baseline|Single Arm|"Single intravenous administration of 18F-Fluciclovine for PET Scan~18F-Fluciclovine PET CT: Radioligand for PET CT scanning"
11253881|NCT02578940|FG000|Participant Flow|Single Arm|"Single intravenous administration of 18F-Fluciclovine for PET Scan~18F-Fluciclovine PET CT: Radioligand for PET CT scanning"
11253882|NCT02578940|OG000|Outcome|18F-Fluciclovine PET CT|"Single intravenous administration of 18F-Fluciclovine for PET Scan~18F-Fluciclovine PET CT: Radioligand for PET CT scanning"
11253883|NCT02578940|OG000|Outcome|18F-fluciclovine PET CT|"Single intravenous administration of 18F-Fluciclovine for PET Scan~18F-Fluciclovine PET CT: Radioligand for PET CT scanning"
11253884|NCT02578940|OG000|Outcome|Treatment-emergent Adverse Events|Number of Subject from SAS who experienced Treatment-emergent Adverse Events
11253885|NCT02578940|EG000|Reported Event|18F-Fluciclovine PET CT|"Single intravenous administration of 18F-Fluciclovine for PET Scan~18F-Fluciclovine PET CT: Radioligand for PET CT scanning"
11253886|NCT02578992|BG000|Baseline|Head-lift Position|"The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."
11253887|NCT02578992|BG001|Baseline|Neutral Position|The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique
11253888|NCT02578992|BG002|Baseline|Total|Total of all reporting groups
11253889|NCT02578992|FG000|Participant Flow|Head-lift Position|"The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."
11253890|NCT02578992|FG001|Participant Flow|Neutral Position|The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
11286454|NCT02888171|BG001|Baseline|Ferrous Sulfate|"Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day~ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day."
11253891|NCT02578992|OG000|Outcome|Head-lift Position|"The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."
11253892|NCT02578992|OG001|Outcome|Neutral Position|The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
11253893|NCT02578992|OG000|Outcome|Neutral Head Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
11253894|NCT02578992|OG001|Outcome|Head-lift Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
11253895|NCT02578992|OG000|Outcome|Neutral Head Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
11253896|NCT02578992|OG001|Outcome|Head-lift Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
11253897|NCT02578992|OG000|Outcome|Neutral Head Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
11253898|NCT02578992|OG001|Outcome|Head-lift Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
11253899|NCT02578992|EG000|Reported Event|Head-lift Position|"The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."
11253900|NCT02578992|EG001|Reported Event|Neutral Position|The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
11253901|NCT02579057|BG000|Baseline|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
11253902|NCT02579057|BG001|Baseline|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
11253903|NCT02579057|BG002|Baseline|Total|Total of all reporting groups
11253904|NCT02579057|FG000|Participant Flow|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, United States Pharmacopeia (USP)"
11253905|NCT02579057|FG001|Participant Flow|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
11253906|NCT02579057|OG000|Outcome|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
11253907|NCT02579057|OG001|Outcome|Furosemide SC|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
11253908|NCT02579057|EG000|Reported Event|Furosemide IV|"Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)~Furosemide Injection Solution, USP"
11253909|NCT02579057|EG001|Reported Event|Furosemide Subcutaneous (SC)|"80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)~Furosemide Injection Solution (SCP-101)"
11253910|NCT02579135|BG000|Baseline|Project HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11253911|NCT02579135|BG001|Baseline|Control: Project Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11253912|NCT02579135|BG002|Baseline|Total|Total of all reporting groups
11286455|NCT02888171|BG002|Baseline|Total|Total of all reporting groups
11253913|NCT02579135|FG000|Participant Flow|Project HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11253914|NCT02579135|FG001|Participant Flow|Control: Project Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11253915|NCT02579135|OG000|Outcome|Project HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11253916|NCT02579135|OG001|Outcome|Control: Project Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11253917|NCT02579135|EG000|Reported Event|Project HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.~No adverse events."
11253918|NCT02579135|EG001|Reported Event|Control: Project Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growth Mindsets: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.~No adverse events."
11253919|NCT02579343|BG000|Baseline|Auricular Acupuncture + Lexipro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.~Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds."
11253920|NCT02579343|BG001|Baseline|Sham Auricular Acupuncture + Lexapro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).~Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current)."
11253921|NCT02579343|BG002|Baseline|Total|Total of all reporting groups
11253922|NCT02579343|FG000|Participant Flow|Auricular Acupuncture + Lexapro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.~Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds."
11253923|NCT02579343|FG001|Participant Flow|Sham Auricular Acupuncture + Lexapro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).~Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current)."
11253924|NCT02579343|OG000|Outcome|Auricular Acupuncture + Lexipro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.~Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds."
11253925|NCT02579343|OG001|Outcome|Sham Auricular Acupuncture + Lexapro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).~Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current)."
11253926|NCT02579343|EG000|Reported Event|Auricular Acupuncture + Lexipro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.~Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds."
11253927|NCT02579343|EG001|Reported Event|Sham Auricular Acupuncture + Lexapro|"Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).~Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current)."
11253928|NCT02579382|BG000|Baseline|TDF + Placebo|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253929|NCT02579382|BG001|Baseline|TDF + Vesatolimod 1 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253930|NCT02579382|BG002|Baseline|TDF + Vesatolimod 2 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253931|NCT02579382|BG003|Baseline|TDF + Vesatolimod 4 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253932|NCT02579382|BG004|Baseline|Total|Total of all reporting groups
11253933|NCT02579382|FG000|Participant Flow|TDF + Placebo|"Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253934|NCT02579382|FG001|Participant Flow|TDF + Vesatolimod 1 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253935|NCT02579382|FG002|Participant Flow|TDF + Vesatolimod 2 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253936|NCT02579382|FG003|Participant Flow|TDF + Vesatolimod 4 mg|"Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.~Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144."
11253937|NCT02579382|OG000|Outcome|TDF + Placebo|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
11253938|NCT02579382|OG001|Outcome|TDF + Vesatolimod 1 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
11253939|NCT02579382|OG002|Outcome|TDF + Vesatolimod 2 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
11253940|NCT02579382|OG003|Outcome|TDF + Vesatolimod 4 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
11253941|NCT02579382|OG000|Outcome|TDF + Placebo|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
11253942|NCT02579382|OG000|Outcome|TDF + Vesatolimod 1 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
11253943|NCT02579382|OG001|Outcome|TDF + Vesatolimod 2 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
11253944|NCT02579382|OG002|Outcome|TDF + Vesatolimod 4 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
11253945|NCT02579382|EG000|Reported Event|TDF + Placebo|Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
11253946|NCT02579382|EG001|Reported Event|TDF + Vesatolimod 1 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod (GS 9620) 1 mg tablet orally once a week (every 7 days) for 12 doses.
11253947|NCT02579382|EG002|Reported Event|TDF + Vesatolimod 2 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
11253948|NCT02579382|EG003|Reported Event|TDF + Vesatolimod 4 mg|Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
11253949|NCT02579382|EG004|Reported Event|TDF Extension From TDF + Placebo|Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; Includes participants who received TDF + Placebo in the Main Study Phase.
11253950|NCT02579382|EG005|Reported Event|TDF Extension From TDF + Vesatolimod 1 mg|Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 1 mg in the Main Study Phase.
11253951|NCT02579382|EG006|Reported Event|TDF Extension From TDF + Vesatolimod 2 mg|Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 2 mg in the Main Study Phase.
11253952|NCT02579382|EG007|Reported Event|TDF Extension From TDF + Vesatolimod 4 mg|Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 4 mg in the Main Study Phase.
11253953|NCT02579421|BG000|Baseline|Progesterone - Males|"200 mg progesterone BID~Progesterone: generic progesterone"
11253954|NCT02579421|BG001|Baseline|Placebo - Males|"placebo BID~placebo: placebo"
11253955|NCT02579421|BG002|Baseline|Progesterone - Females|"200 mg progesterone BID~Progesterone: generic progesterone"
11253956|NCT02579421|BG003|Baseline|Placebo - Females|"placebo BID~placebo: placebo"
11253957|NCT02579421|BG004|Baseline|Total|Total of all reporting groups
11253958|NCT02579421|FG000|Participant Flow|Progesterone - Males|"200 mg progesterone BID~Progesterone: generic progesterone"
11253959|NCT02579421|FG001|Participant Flow|Placebo - Males|"placebo BID~placebo: placebo"
11253960|NCT02579421|FG002|Participant Flow|Progesterone - Females|200 mg progesterone BID
11253961|NCT02579421|FG003|Participant Flow|Placebo - Females|pacebo BID
11253962|NCT02579421|OG000|Outcome|Males - Progesterone|"200 mg progesterone BID~Progesterone: generic progesterone"
11253963|NCT02579421|OG001|Outcome|Males - Placebo|"placebo BID~placebo: placebo"
11253964|NCT02579421|OG002|Outcome|Females - Progesterone|"200 mg progesterone BID~Progesterone: generic progesterone"
11253965|NCT02579421|OG003|Outcome|Females - Placebo|"placebo BID~placebo: placebo"
11253966|NCT02579421|EG000|Reported Event|Progesterone - Males|"200 mg progesterone BID~Progesterone: generic progesterone"
11253967|NCT02579421|EG001|Reported Event|Placebo - Males|"placebo BID~placebo: placebo"
11253968|NCT02579421|EG002|Reported Event|Progesterone - Females|200 mg progesterone BID
11253969|NCT02579421|EG003|Reported Event|Placebo - Females|pacebo BID
11253970|NCT02579603|BG000|Baseline|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
11253971|NCT02579603|BG001|Baseline|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
11253972|NCT02579603|BG002|Baseline|Total|Total of all reporting groups
11253973|NCT02579603|FG000|Participant Flow|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
11253974|NCT02579603|FG001|Participant Flow|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
11253975|NCT02579603|OG000|Outcome|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
11253976|NCT02579603|OG001|Outcome|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
11253977|NCT02579603|OG000|Outcome|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
11253978|NCT02579603|EG000|Reported Event|Nintedanib|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
11253979|NCT02579603|EG001|Reported Event|Nintedanib + Pirfenidone|Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
11253980|NCT02579616|BG000|Baseline|Lenvatinib 24 mg|Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
11253981|NCT02579616|FG000|Participant Flow|Lenvatinib 24 mg|Participants received lenvatinib 24 milligram (mg) capsules, orally, once daily in 28-days treatment cycles until disease progression, adverse events (AEs), withdrawal of consent, or participant's choice (up to Cycle 40).
11253982|NCT02579616|OG000|Outcome|Lenvatinib 24 mg|Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
11253983|NCT02579616|EG000|Reported Event|Lenvatinib 24 mg|Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
11286456|NCT02888171|FG000|Participant Flow|Ferric Citrate|"Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.~ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals."
11286457|NCT02888171|FG001|Participant Flow|Ferrous Sulfate|"Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day~ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day."
11286458|NCT02888171|OG000|Outcome|Ferric Citrate|"Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.~ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals."
11286459|NCT02888171|OG001|Outcome|Ferrous Sulfate|"Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day~ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day."
11286460|NCT02888171|EG000|Reported Event|Ferric Citrate|"Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.~ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals."
11286461|NCT02888171|EG001|Reported Event|Ferrous Sulfate|"Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day~ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day."
11286462|NCT02888665|BG000|Baseline|Phase 1, Part 1|Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab.
11286463|NCT02888665|BG001|Baseline|Phase 1, Part 2|Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose of pembrolizumab.
11286464|NCT02888665|BG002|Baseline|Phase 2|Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose pembrolizumab.
11286465|NCT02888665|BG003|Baseline|Total|Total of all reporting groups
11286466|NCT02888665|FG000|Participant Flow|Phase 1, Part 1|Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab.
11286467|NCT02888665|FG001|Participant Flow|Phase 1, Part 2|Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose of pembrolizumab.
11286468|NCT02888665|FG002|Participant Flow|Phase 2|Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose pembrolizumab.
11286469|NCT02888665|OG000|Outcome|Phase 1 Cohort 1|Subjects received 45 mg/m2 of doxorubicin plus 200 mg flat dose of pembrolizumab.
11286470|NCT02888665|OG001|Outcome|Phase 1 Cohort 2|Subjects received 75 mg/m2 of doxorubicin plus 200 mg flat dose of pembrolizumab.
11286471|NCT02888665|OG000|Outcome|Phase 2: Treatment (Pembrolizumab, Doxorubicin Hydrochloride)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11286472|NCT02888665|OG000|Outcome|Treatment (Pembrolizumab, Doxorubicin Hydrochloride)|"Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Doxorubicin Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11286473|NCT02888665|EG000|Reported Event|Phase 1 Cohort 1|Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab.
11286474|NCT02888665|EG001|Reported Event|Phase 1 Cohort 2|Subjects received 75 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab.
11286475|NCT02888665|EG002|Reported Event|Phase 2|Subjects received 75 mg/m2 doxorubicin plus 200 mg flat dose pembrolizumab.
11286476|NCT02888691|BG000|Baseline|Study Cohort|Baseline characteristics are for the whole study cohort, not for each of study arm of the cross-over study
11286477|NCT02888691|FG000|Participant Flow|Low Carbohydrate Diet|"< 100 grams of carbohydrate per day~Low carbohydrate diet"
11253984|NCT02579629|BG000|Baseline|Ropivacaine 0.1%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253985|NCT02579629|BG001|Baseline|Ropivacaine 0.2%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253986|NCT02579629|BG002|Baseline|Normal Saline|Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253987|NCT02579629|BG003|Baseline|Total|Total of all reporting groups
11253988|NCT02579629|FG000|Participant Flow|Ropivacaine 0.1%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253989|NCT02579629|FG001|Participant Flow|Ropivacaine 0.2%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253990|NCT02579629|FG002|Participant Flow|Normal Saline|Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253991|NCT02579629|OG000|Outcome|Ropivacaine 0.1%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253992|NCT02579629|OG001|Outcome|Ropivacaine 0.2%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253993|NCT02579629|OG002|Outcome|Normal Saline|Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253994|NCT02579629|EG000|Reported Event|Ropivacaine 0.1%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253995|NCT02579629|EG001|Reported Event|Ropivacaine 0.2%|Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253996|NCT02579629|EG002|Reported Event|Normal Saline|Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
11253997|NCT02579759|BG000|Baseline|PXT3003 Dose 1|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months~PXT3003 dose 1: Liquid oral solution, 5 ml twice a day, morning and evening with food"
11253998|NCT02579759|BG001|Baseline|PXT3003 Dose 2|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months~PXT3003 dose 2: Liquid oral solution, 5 ml twice a day, morning and evening with food"
11253999|NCT02579759|BG002|Baseline|Placebo|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months~placebo: Liquid oral solution, 5 ml twice a day, morning and evening with food"
11254000|NCT02579759|BG003|Baseline|Total|Total of all reporting groups
11254001|NCT02579759|FG000|Participant Flow|PXT3003 Dose 1|"Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food)."
11254002|NCT02579759|FG001|Participant Flow|PXT3003 Dose 2|"Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food)."
11254003|NCT02579759|FG002|Participant Flow|Placebo|"Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food)."
11254004|NCT02579759|OG000|Outcome|PXT3003 Dose 1|"Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food)."
11254005|NCT02579759|OG001|Outcome|PXT3003 Dose 2|"Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food)."
11254006|NCT02579759|OG002|Outcome|Placebo|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food)."
11254007|NCT02579759|OG002|Outcome|Placebo|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months~placebo: Liquid oral solution, 5 ml twice a day, morning and evening with food"
11254008|NCT02579759|OG002|Outcome|Placebo|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months~PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food)."
11254009|NCT02579759|EG000|Reported Event|PXT3003 Dose 1|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food)."
11254010|NCT02579759|EG001|Reported Event|PXT3003 Dose 2|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food)."
11254011|NCT02579759|EG002|Reported Event|Placebo|"Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.~PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food)."
11254012|NCT02579772|BG000|Baseline|All Study Participants|Participants who were randomized to receive either N-acetylcysteine (NAC) or placebo pills
11254013|NCT02579772|FG000|Participant Flow|N-acetylcysteine, Then Placebo|Participants first received N-acetylcysteine (NAC; 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment). After a washout period of at least 7 days, they then received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
11254014|NCT02579772|FG001|Participant Flow|Placebo, Then N-acetylcysteine|Participants first received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment. After a washout period of at least 7 days, they then received N-acetylcysteine (NAC; 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment).
11254015|NCT02579772|OG000|Outcome|N-acetylcysteine|Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.
11254016|NCT02579772|OG001|Outcome|Placebo|3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
11254017|NCT02579772|EG000|Reported Event|N-acetylcysteine|Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.
11254018|NCT02579772|EG001|Reported Event|Placebo|3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
11254019|NCT02579863|BG000|Baseline|Pembrolizumab + Lenalidomide + Dexamethasone|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254020|NCT02579863|BG001|Baseline|Lenolidomide + Dexamethasone|Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254021|NCT02579863|BG002|Baseline|Total|Total of all reporting groups
11254022|NCT02579863|FG000|Participant Flow|Pembrolizumab + Lenalidomide + Dexamethasone|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254023|NCT02579863|FG001|Participant Flow|Lenolidomide + Dexamethasone|Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254024|NCT02579863|OG000|Outcome|Pembrolizumab + Lenalidomide + Dexamethasone|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254025|NCT02579863|OG001|Outcome|Lenolidomide + Dexamethasone|Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254026|NCT02579863|EG000|Reported Event|Pembrolizumab + Lenalidomide + Dexamethasone|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254027|NCT02579863|EG001|Reported Event|Lenolidomide + Dexamethasone|Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
11254028|NCT02579876|BG000|Baseline|Viaskin Milk 500 mcg|"Viaskin patch containing milk protein. The patch is applied to the skin~Viaskin Milk 500 mcg: Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins."
11254029|NCT02579876|BG001|Baseline|Viaskin Placebo|"Viaksin patch without any milk protein.~Viaskin Placebo: Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation."
11254030|NCT02579876|BG002|Baseline|Total|Total of all reporting groups
11254031|NCT02579876|FG000|Participant Flow|Viaskin Milk 500 mcg|"Viaskin patch containing milk protein. The patch is applied to the skin~Viaskin Milk 500 mcg: Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins."
11254032|NCT02579876|FG001|Participant Flow|Viaskin Placebo|"Viaksin patch without any milk protein.~Viaskin Placebo: Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation."
11254033|NCT02579876|OG000|Outcome|Viaskin Milk 500 mcg|"Viaskin patch containing milk protein. The patch is applied to the skin~Viaskin Milk 500 mcg: Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins."
11254034|NCT02579876|OG001|Outcome|Viaskin Placebo|"Viaksin patch without any milk protein.~Viaskin Placebo: Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation."
11254035|NCT02579876|EG000|Reported Event|Viaskin Milk 500 mcg|"Viaskin patch containing milk protein. The patch is applied to the skin~Viaskin Milk 500 mcg: Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins."
11254036|NCT02579876|EG001|Reported Event|Viaskin Placebo|"Viaksin patch without any milk protein.~Viaskin Placebo: Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation."
11286478|NCT02888691|FG001|Participant Flow|High Carbohydrate Diet|"> 250 grams of carbohydrate per day~High carbohydrate diet"
11286479|NCT02888691|OG000|Outcome|Low Carbohydrate Diet|"< 100 grams of carbohydrate per day~Low carbohydrate diet"
11286480|NCT02888691|OG001|Outcome|High Carbohydrate Diet|"> 250 grams of carbohydrate per day~High carbohydrate diet"
11286481|NCT02888691|EG000|Reported Event|Low Carbohydrate Diet|"< 100 grams of carbohydrate per day~Low carbohydrate diet"
11254037|NCT02579915|BG000|Baseline|FaceAnxiety - Mental Habits|"Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.~FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254038|NCT02579915|BG001|Baseline|FaceAnxiety - Symptom Tracking|"Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254039|NCT02579915|BG002|Baseline|Total|Total of all reporting groups
11254040|NCT02579915|FG000|Participant Flow|FaceAnxiety - Mental Habits|"Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.~FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254041|NCT02579915|FG001|Participant Flow|FaceAnxiety - Symptom Tracking|"Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254042|NCT02579915|OG000|Outcome|FaceAnxiety - Mental Habits|"Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.~FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254043|NCT02579915|OG001|Outcome|FaceAnxiety - Symptom Tracking|"Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254044|NCT02579915|EG000|Reported Event|FaceAnxiety - Mental Habits|"Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.~FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254045|NCT02579915|EG001|Reported Event|FaceAnxiety - Symptom Tracking|"Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.~Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage"
11254046|NCT02579928|BG000|Baseline|Received Ketamine in the First Infusion|Participants that were randomly assigned to receive a dose of 0.5 mg/kg of Ketamine to be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. Participants were monitored continuously during the procedure, and every hour for three hours after the infusion.
11254047|NCT02579928|BG001|Baseline|Received Midazolam in the First Infusion|Participants that were assigned to receive a dose of 0.045mg/kg of Midazolam, administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. Participants were monitored continuously during the procedure, and every hour for three hours after the infusion
11254048|NCT02579928|BG002|Baseline|Total|Total of all reporting groups
11254049|NCT02579928|FG000|Participant Flow|Ketamine First Then Midazolam|"Participants received a Ketamine infusion under blinded conditions, followed by a Midazolam infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.~Ketamine was infused at a dose of 0.5mg/kg over 40 minutes and midazolam was infused at a dose of 0.045mg/kg over 40 minutes on the Hospital Research Unit of YNHH."
11254050|NCT02579928|FG001|Participant Flow|Midazolam First Then Ketamine|"Participants received a midazolam infusion under blinded conditions, followed by a ketamine infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.~Midazolam was infused at a dose of 0.045mg/kg over 40 minutes and ketamine was infused at a dose of 0.5mg/kg over 40 minutes on the Hospital Research Unit of YNHH."
11286482|NCT02888691|EG001|Reported Event|High Carbohydrate Diet|"> 250 grams of carbohydrate per day~High carbohydrate diet"
11254051|NCT02579928|OG000|Outcome|Ketamine|"Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg). The participants were monitored continuously during the procedure, and every hour for three hours after the infusion.~Followed up clinically for the next 2 weeks."
11254052|NCT02579928|OG001|Outcome|Midazolam|Participants were assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg), The participants were monitored continuously during the procedure, and every hour for three hours after the infusion.They were followed clinically for two weeks.
11254053|NCT02579928|EG000|Reported Event|Ketamine|"Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg).~Ketamine: A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion."
11254054|NCT02579928|EG001|Reported Event|Midazolam|"Participants were randomly assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg),~Midazolam: A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion."
11254055|NCT02580188|BG000|Baseline|Group M|Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11254056|NCT02580188|BG001|Baseline|Group D|"Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block~sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block)."
11254057|NCT02580188|BG002|Baseline|Total|Total of all reporting groups
11254058|NCT02580188|FG000|Participant Flow|Group M|Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11254059|NCT02580188|FG001|Participant Flow|Group D|"Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block~sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block)."
11254060|NCT02580188|OG000|Outcome|Moderate Block|Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11254061|NCT02580188|OG001|Outcome|Deep Block|"Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block~sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block)."
11254062|NCT02580188|OG001|Outcome|Deep Block|"Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block~sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block)."
11254063|NCT02580188|EG000|Reported Event|Group M|Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
11254064|NCT02580188|EG001|Reported Event|Group D|"Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block~sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block)."
11254065|NCT02580201|BG000|Baseline|Group 1|tOPV-vaccinated healthy children aged 1 to 5 years to receive 1 dose of SABIN
11254066|NCT02580201|BG001|Baseline|Group 2|Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart
11254067|NCT02580201|BG002|Baseline|Total|Total of all reporting groups
11254068|NCT02580201|FG000|Participant Flow|Group1|tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV
11254069|NCT02580201|FG001|Participant Flow|Group 2|Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
11254070|NCT02580201|OG000|Outcome|Group1|tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV
11254071|NCT02580201|OG001|Outcome|Group 2|Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
11254072|NCT02580201|OG000|Outcome|Group 2|Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
11254073|NCT02580201|EG000|Reported Event|Group1|tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV
11254074|NCT02580201|EG001|Reported Event|Group 2|Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
11254075|NCT02580240|BG000|Baseline|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
11254076|NCT02580240|BG001|Baseline|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
11254077|NCT02580240|BG002|Baseline|Total|Total of all reporting groups
11254078|NCT02580240|FG000|Participant Flow|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
11254079|NCT02580240|FG001|Participant Flow|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
11254080|NCT02580240|OG000|Outcome|Placebo|"Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.~saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar."
11254081|NCT02580240|OG001|Outcome|Hydrocortisone|"Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).~Hydrocortisone: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped)."
11254082|NCT02580240|EG000|Reported Event|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
11254083|NCT02580240|EG001|Reported Event|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
11254084|NCT02580318|BG000|Baseline|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
11254085|NCT02580318|FG000|Participant Flow|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
11254086|NCT02580318|OG000|Outcome|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
11254087|NCT02580318|EG000|Reported Event|All Study Participants|participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
11254088|NCT02580357|BG000|Baseline|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254089|NCT02580357|BG001|Baseline|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254090|NCT02580357|BG002|Baseline|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254091|NCT02580357|BG003|Baseline|Total|Total of all reporting groups
11254092|NCT02580357|FG000|Participant Flow|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11286483|NCT02888756|BG000|Baseline|iHIVARNA-01|"Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval~iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption~TriMix: Therapeutic vaccination, followed by treatment interruption"
11254093|NCT02580357|FG001|Participant Flow|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254094|NCT02580357|FG002|Participant Flow|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254095|NCT02580357|OG000|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254096|NCT02580357|OG001|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254097|NCT02580357|OG002|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254098|NCT02580357|EG000|Reported Event|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254099|NCT02580357|EG001|Reported Event|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11286484|NCT02888756|BG001|Baseline|TriMix|"Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval~TriMix: Therapeutic vaccination, followed by treatment interruption"
11286485|NCT02888756|BG002|Baseline|Placebo|"Water for injection 3 vaccinations, two weeks interval~Placebo: Therapeutic vaccination, followed by treatment interruption"
11286486|NCT02888756|BG003|Baseline|Total|Total of all reporting groups
11254100|NCT02580357|EG002|Reported Event|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
11254101|NCT02580591|BG000|Baseline|Placebo Matching Empagliflozin|Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254102|NCT02580591|BG001|Baseline|Empagliflozin 2.5 Milligram (mg)|Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254103|NCT02580591|BG002|Baseline|Empagliflozin 10 mg|Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254104|NCT02580591|BG003|Baseline|Empagliflozin 25 mg|Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254105|NCT02580591|BG004|Baseline|Total|Total of all reporting groups
11254106|NCT02580591|FG000|Participant Flow|Placebo Matching Empagliflozin|Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254107|NCT02580591|FG001|Participant Flow|Empagliflozin 2.5 Milligram (mg)|Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254108|NCT02580591|FG002|Participant Flow|Empagliflozin 10 mg|Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254109|NCT02580591|FG003|Participant Flow|Empagliflozin 25 mg|Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254110|NCT02580591|OG000|Outcome|Placebo Matching Empagliflozin|Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254111|NCT02580591|OG001|Outcome|Empagliflozin 2.5 Milligram (mg)|Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254112|NCT02580591|OG002|Outcome|Empagliflozin 10 mg|Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254113|NCT02580591|OG003|Outcome|Empagliflozin 25 mg|Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254114|NCT02580591|EG000|Reported Event|Placebo Matching Empagliflozin|Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254115|NCT02580591|EG001|Reported Event|Empagliflozin 2.5 Milligram (mg)|Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254116|NCT02580591|EG002|Reported Event|Empagliflozin 10 mg|Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254117|NCT02580591|EG003|Reported Event|Empagliflozin 25 mg|Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
11254118|NCT02580799|BG000|Baseline|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
11254119|NCT02580799|FG000|Participant Flow|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
11254120|NCT02580799|OG000|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
11254121|NCT02580799|EG000|Reported Event|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
11254122|NCT02580877|BG000|Baseline|67.5 mg Oral Insulin Crystals Daily|"67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months~67.5 mg oral insulin crystals daily: human insulin crystals in capsules"
11254123|NCT02580877|BG001|Baseline|500mg Oral Insulin Crystals Every Other Week|"500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months~500mg oral insulin crystals every other week: human insulin crystals in capsules"
11254124|NCT02580877|BG002|Baseline|Total|Total of all reporting groups
11254125|NCT02580877|FG000|Participant Flow|67.5 mg Oral Insulin Crystals Daily|"67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months~67.5 mg oral insulin crystals daily: human insulin crystals in capsules"
11254126|NCT02580877|FG001|Participant Flow|500 mg Oral Insulin Crystals Every Other Week|"500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months~500 mg oral insulin crystals every other week: human insulin crystals in capsules"
11254127|NCT02580877|OG000|Outcome|67.5 mg Oral Insulin Crystals Daily|"67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months~67.5 mg oral insulin crystals daily: human insulin crystals in capsules"
11254128|NCT02580877|OG001|Outcome|500 mg Oral Insulin Crystals Every Other Week|"500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months~500 mg oral insulin crystals every other week: human insulin crystals in capsules"
11254129|NCT02580877|OG001|Outcome|500mg Oral Insulin Crystals Every Other Week|"500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months~500mg oral insulin crystals every other week: human insulin crystals in capsules"
11254130|NCT02580877|EG000|Reported Event|67.5 mg Oral Insulin Crystals Daily|"67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months~67.5 mg oral insulin crystals daily: human insulin crystals in capsules"
11254131|NCT02580877|EG001|Reported Event|500 mg Oral Insulin Crystals Every Other Week|"500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months~500 mg oral insulin crystals every other week: human insulin crystals in capsules"
11254132|NCT02581111|BG000|Baseline|Naloxone|"Naloxone 8-mg IV given once after baseline ABG~Naloxone: Naloxone 8-mg IV bolus"
11254133|NCT02581111|BG001|Baseline|Placebo|"Equivalent volume of saline given once~Normal saline"
11254134|NCT02581111|BG002|Baseline|Total|Total of all reporting groups
11254135|NCT02581111|FG000|Participant Flow|Naloxone|"Naloxone 8-mg IV given once after baseline ABG~Naloxone: Naloxone 8-mg IV bolus"
11254136|NCT02581111|FG001|Participant Flow|Placebo|"Equivalent volume of saline given once~Normal saline"
11254137|NCT02581111|OG000|Outcome|Naloxone|"Naloxone 8-mg IV given once after baseline ABG~Naloxone: Naloxone 8-mg IV bolus"
11254138|NCT02581111|OG001|Outcome|Placebo|"Equivalent volume of saline given once~Normal saline"
11254139|NCT02581111|EG000|Reported Event|Naloxone|"Naloxone 8-mg IV given once after baseline ABG~Naloxone: Naloxone 8-mg IV bolus"
11254140|NCT02581111|EG001|Reported Event|Placebo|"Equivalent volume of saline given once~Normal saline"
11254141|NCT02581163|BG000|Baseline|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254142|NCT02581163|FG000|Participant Flow|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254143|NCT02581163|OG000|Outcome|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254144|NCT02581163|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254145|NCT02581163|EG001|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily) up to 24 weeks
11254146|NCT02581163|EG002|Reported Event|Ombitasvir/Paritaprevir/Ritonavir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks
11254147|NCT02581163|EG003|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254148|NCT02581189|BG000|Baseline|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254149|NCT02581189|FG000|Participant Flow|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254150|NCT02581189|OG000|Outcome|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254151|NCT02581189|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks
11254152|NCT02581189|EG001|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254153|NCT02581189|EG002|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily) up to 24 weeks
11254154|NCT02581189|EG003|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254155|NCT02581202|BG000|Baseline|HIV-1 Infected Participants|HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
11254156|NCT02581202|FG000|Participant Flow|Human Immunodeficiency Virus 1 (HIV-1) Infected Participants|HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
11254157|NCT02581202|OG000|Outcome|HIV-1 Infected Participants|HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
11254158|NCT02581202|OG000|Outcome|HIV-1 Infected Participants|HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
11254159|NCT02581202|EG000|Reported Event|HIV-1 Infected Participants|"Treatment-experienced HIV-1 infected participants with an undetectable plasma HIV-1 RNA level~lopinavir/ritonavir: tablet~Lamivudine: tablet"
11254160|NCT02581345|BG000|Baseline|Part 1 and Part 2: M923|Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor-alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.
11254161|NCT02581345|BG001|Baseline|Part 1 and Part 2: EU RPP|Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants from this arm were then randomized at Week 16 into either Arm: Continuous EU RPP (continued EU RPP from Weeks 17 to 48 [last dose at Week 47]) or Arm: Transition EU RPP (transition to M923 at Week 17; then to EU RPP at Week 25; and then to M923 at Week 37 [last dose at Week 47]).
11254162|NCT02581345|BG002|Baseline|Total|Total of all reporting groups
11254163|NCT02581345|FG000|Participant Flow|Part 1 and Part 2: M923|Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor-alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
11254164|NCT02581345|FG001|Participant Flow|Part 1: EU RPP|Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection
11254165|NCT02581345|FG002|Participant Flow|Part 1: EU RPP; Part 2: Transition|Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
11254166|NCT02581345|FG003|Participant Flow|Part 1: EU RPP; Part 2: Continous|Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
11254167|NCT02581345|OG000|Outcome|Part 1: M923|Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor-alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254168|NCT02581345|OG001|Outcome|Part 1: EU RPP|Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254169|NCT02581345|OG000|Outcome|Part 1: M923|Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254170|NCT02581345|OG001|Outcome|Part 1: EU RPP|Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254171|NCT02581345|OG000|Outcome|Part 2: M923|Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
11254172|NCT02581345|OG001|Outcome|Part 2: Transition EU RPP|At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
11254173|NCT02581345|OG002|Outcome|Part 2: Continuous EU RPP|Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
11254174|NCT02581345|OG002|Outcome|Part 2: M923|Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
11254175|NCT02581345|OG003|Outcome|Part 2: Transition EU RPP|At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
11254176|NCT02581345|OG004|Outcome|Part 2: Continuous EU RPP|Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
11254177|NCT02581345|OG000|Outcome|Part 1 and Part 2: M923|Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.
11254178|NCT02581345|EG000|Reported Event|Part 1: M923|Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor-alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254179|NCT02581345|EG001|Reported Event|Part 1: EU RPP|Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
11254180|NCT02581345|EG002|Reported Event|Part 2: M923|Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
11254181|NCT02581345|EG003|Reported Event|Part 2: Transition EU RPP|At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
11254182|NCT02581345|EG004|Reported Event|Part 2: Continuous EU RPP|Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
11254183|NCT02581384|BG000|Baseline|Cohort 2 Dose Level 2 [Phase I and II]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254184|NCT02581384|FG000|Participant Flow|Cohort 2 Dose Level 2 [Phase I]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254185|NCT02581384|FG001|Participant Flow|Cohort 2 Dose Level 2 [Phase II]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254186|NCT02581384|OG000|Outcome|Cohort 2 Dose Level 2 [Phase I]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254187|NCT02581384|OG000|Outcome|Cohort 2 Dose Level 2 [Phase I and II]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254188|NCT02581384|OG001|Outcome|Cohort 2 Dose Level 2 [Phase II]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254189|NCT02581384|EG000|Reported Event|Cohort 2 Dose Level 2 [Phase I]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254190|NCT02581384|EG001|Reported Event|Cohort 2 Dose Level 2 [Phase II]|"Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.~Stereotactic Body Radiotherapy (SBRT)"
11254191|NCT02581410|BG000|Baseline|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254192|NCT02581410|BG001|Baseline|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
11254193|NCT02581410|BG002|Baseline|Total|Total of all reporting groups
11254194|NCT02581410|FG000|Participant Flow|GSK1437173A Group|Subjects above or equal to (≥) 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254195|NCT02581410|FG001|Participant Flow|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
11254196|NCT02581410|OG000|Outcome|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254197|NCT02581410|OG001|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254198|NCT02581410|OG001|Outcome|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
11254199|NCT02581410|EG000|Reported Event|GSK1437173A Group|Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254200|NCT02581410|EG001|Reported Event|Control Group|Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
11254201|NCT02581475|BG000|Baseline|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
11254202|NCT02581475|BG001|Baseline|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
11254203|NCT02581475|BG002|Baseline|Total|Total of all reporting groups
11254204|NCT02581475|FG000|Participant Flow|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
10969901|NCT00908037|FG007|Participant Flow|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
11254205|NCT02581475|FG001|Participant Flow|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
11254206|NCT02581475|OG000|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
11254207|NCT02581475|OG001|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
11254208|NCT02581475|EG000|Reported Event|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
11254209|NCT02581475|EG001|Reported Event|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
11254210|NCT02581488|BG000|Baseline|Santyl|Collagenase ointment applied topically once per day for up to 6 weeks.
11254211|NCT02581488|BG001|Baseline|Product Containing Silver|Products containing silver was applied per Investigator instructions and instructions for use/package insert for up to 6 weeks. Silver product was not specified by the protocol; Investigators chose the appropriate silver containing product for each diabetic foot ulcer.
11254212|NCT02581488|BG002|Baseline|Total|Total of all reporting groups
11254213|NCT02581488|FG000|Participant Flow|Santyl|Collagenase ointment applied topically once per day for up to 6 weeks.
11254214|NCT02581488|FG001|Participant Flow|Product Containing Silver|Products containing silver was applied per Investigator instructions and instructions for use/package insert for up to 6 weeks. Silver product was not specified by the protocol; Investigators chose the appropriate silver containing product for each diabetic foot ulcer.
11254215|NCT02581488|OG000|Outcome|Santyl|Collagenase ointment applied topically once per day for up to 6 weeks.
11254216|NCT02581488|OG001|Outcome|Product Containing Silver|Products containing silver was applied per Investigator instructions and instructions for use/package insert for up to 6 weeks. Silver product was not specified by the protocol; Investigators chose the appropriate silver containing product for each diabetic foot ulcer.
11254217|NCT02581488|EG000|Reported Event|Santyl|Collagenase ointment applied topically once per day for up to 6 weeks.
11254218|NCT02581488|EG001|Reported Event|Product Containing Silver|Products containing silver was applied per Investigator instructions and instructions for use/package insert for up to 6 weeks. Silver product was not specified by the protocol; Investigators chose the appropriate silver containing product for each diabetic foot ulcer.
11254219|NCT02581839|BG000|Baseline|Eribulin Mesylate|"The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.~MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician~Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician"
11254220|NCT02581839|FG000|Participant Flow|Eribulin Mesylate|"The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.~MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician~Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician"
11254221|NCT02581839|OG000|Outcome|Eribulin Mesylate|"The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.~MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician~Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician"
11254222|NCT02581839|EG000|Reported Event|Eribulin Mesylate|"The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.~MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate~Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician~Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician"
11254223|NCT02581865|BG000|Baseline|Placebo|Placebo administered once daily for 8 weeks
11254224|NCT02581865|BG001|Baseline|NBI-98854 40 mg|Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks
11254225|NCT02581865|BG002|Baseline|NBI-98854 80 mg|NBI-98854 80 mg dose will be titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
11254226|NCT02581865|BG003|Baseline|Total|Total of all reporting groups
11254227|NCT02581865|FG000|Participant Flow|Placebo|Placebo administered once daily for 8 weeks
11254228|NCT02581865|FG001|Participant Flow|NBI-98854 40 mg|Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks
11254229|NCT02581865|FG002|Participant Flow|NBI-98854 80 mg|NBI-98854 80 mg dose will be titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
11254230|NCT02581865|OG000|Outcome|Placebo|Placebo administered once daily for 8 weeks
11254231|NCT02581865|OG001|Outcome|NBI-98854 40 mg|Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks
11254232|NCT02581865|OG002|Outcome|NBI-98854 80 mg|NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
11254233|NCT02581865|OG002|Outcome|NBI-98854 80 mg|NBI-98854 80 mg dose titrated in a blinded fashion (subjects received 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
11254234|NCT02581865|OG002|Outcome|NBI-98854 80 mg|NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period
11254235|NCT02581865|OG002|Outcome|NBI-98854 80 mg|NBI-98854 80 mg dose titrated in a blinded fashion (subjects will received 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period).
11254236|NCT02581865|EG000|Reported Event|Placebo|Placebo administered once daily for 8 weeks
11254237|NCT02581865|EG001|Reported Event|NBI-98854 40 mg|Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks
11254238|NCT02581865|EG002|Reported Event|NBI-98854 80 mg|NBI-98854 80 mg dose was titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period
11254239|NCT02581891|BG000|Baseline|Early-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254240|NCT02581891|BG001|Baseline|Late-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254241|NCT02581891|BG002|Baseline|Total|Total of all reporting groups
11254242|NCT02581891|FG000|Participant Flow|Early-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254243|NCT02581891|FG001|Participant Flow|Late-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254244|NCT02581891|OG000|Outcome|Early-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254245|NCT02581891|OG001|Outcome|Late-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254246|NCT02581891|EG000|Reported Event|Early-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254247|NCT02581891|EG001|Reported Event|Late-start T&E Arm|All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
11254248|NCT02581891|EG002|Reported Event|Treated, But Not Randomized|Participants were treated during the initiation phase, received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4 and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks)at Week 16, but were not randomized to a treatment arm after the initiation phase.
11254249|NCT02581995|BG000|Baseline|Aflibercept|Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
11254250|NCT02581995|FG000|Participant Flow|Aflibercept|Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
11254251|NCT02581995|OG000|Outcome|Aflibercept|Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
11254252|NCT02581995|EG000|Reported Event|Aflibercept|Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period.
11254253|NCT02582151|BG000|Baseline|Sham Tibial Nerve Stimulation|"Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254254|NCT02582151|BG001|Baseline|Tibial Nerve Stimulation|"Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254255|NCT02582151|BG002|Baseline|Total|Total of all reporting groups
11254256|NCT02582151|FG000|Participant Flow|Sham Tibial Nerve Stimulation|"Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254257|NCT02582151|FG001|Participant Flow|Tibial Nerve Stimulation|"Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254258|NCT02582151|OG000|Outcome|Sham Tibial Nerve Stimulation|"Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254259|NCT02582151|OG001|Outcome|Tibial Nerve Stimulation|"Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254260|NCT02582151|EG000|Reported Event|Sham Tibial Nerve Stimulation|"Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254261|NCT02582151|EG001|Reported Event|Tibial Nerve Stimulation|"Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.~EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents."
11254262|NCT02582216|BG000|Baseline|Open Label|3D augmented reality
11254263|NCT02582216|FG000|Participant Flow|Open Label|3D augmented reality
11254264|NCT02582216|OG000|Outcome|Open Label|each patients received 5 3D augmented reality over a period of 5 days. Each treatment lasted a total of 20 minutes
11254265|NCT02582216|OG000|Outcome|Open Label|Each patient received a 3D augmented reality
11254266|NCT02582216|EG000|Reported Event|Open Label|patients received a 3D augmented reality treatment
11254267|NCT02582242|BG000|Baseline|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254268|NCT02582242|BG001|Baseline|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254269|NCT02582242|BG002|Baseline|Total|Total of all reporting groups
11254270|NCT02582242|FG000|Participant Flow|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received biphasic insulin aspart 30 (BIAsp 30; a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) three times daily (TID); before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as subcutaneous (s.c.; under the skin) injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254271|NCT02582242|FG001|Participant Flow|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 twice daily (BID); before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254272|NCT02582242|OG000|Outcome|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254273|NCT02582242|OG001|Outcome|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254274|NCT02582242|EG000|Reported Event|Biphasic Insulin Aspart 30 (Three Times Daily)|Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254275|NCT02582242|EG001|Reported Event|Biphasic Insulin Aspart 30 (Twice Daily)|Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period.
11254276|NCT02582255|BG000|Baseline|Group 1|IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
11254277|NCT02582255|BG001|Baseline|Group 2|IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
11254278|NCT02582255|BG002|Baseline|Total|Total of all reporting groups
11254279|NCT02582255|FG000|Participant Flow|Group 1|IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
11254280|NCT02582255|FG001|Participant Flow|Group 2|IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
11254281|NCT02582255|OG000|Outcome|Group 1|IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
11254282|NCT02582255|OG001|Outcome|Group 2|IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
11254283|NCT02582255|OG000|Outcome|Group 2|IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
11254284|NCT02582255|EG000|Reported Event|Group 1|IPV-vaccinated children receiving 1 dose of SABIN mOPV2.
11254285|NCT02582255|EG001|Reported Event|Group 2|IPV-vaccinated children receiving 2 doses of SABIN mOPV2.
11254286|NCT02582515|BG000|Baseline|D-cycloserine + Habit Reversal Training|"Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~D-cycloserine"
11254287|NCT02582515|BG001|Baseline|Placebo + Habit Reversal Training|"Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~Placebo"
11254288|NCT02582515|BG002|Baseline|Total|Total of all reporting groups
11254289|NCT02582515|FG000|Participant Flow|D-cycloserine + Habit Reversal Training|"Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~D-cycloserine"
11254290|NCT02582515|FG001|Participant Flow|Placebo + Habit Reversal Training|"Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~Placebo"
11254291|NCT02582515|OG000|Outcome|D-cycloserine + Habit Reversal Training|"Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~D-cycloserine"
11254292|NCT02582515|OG001|Outcome|Placebo + Habit Reversal Training|"Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~Placebo"
11254293|NCT02582515|EG000|Reported Event|D-cycloserine + Habit Reversal Training|"Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~D-cycloserine"
11254294|NCT02582515|EG001|Reported Event|Placebo + Habit Reversal Training|"Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.~Placebo"
11254295|NCT02582632|BG000|Baseline|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
11254296|NCT02582632|FG000|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
11254297|NCT02582632|OG000|Outcome|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
11254298|NCT02582632|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir|ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
11254299|NCT02582658|BG000|Baseline|ABBVIE REGIMEN +/- Ribavirin (RBV)|ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
11254300|NCT02582658|FG000|Participant Flow|ABBVIE REGIMEN +/- Ribavirin (RBV)|ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
10969902|NCT00908037|FG008|Participant Flow|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969903|NCT00908037|FG009|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969904|NCT00908037|FG010|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969905|NCT00908037|FG011|Participant Flow|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969906|NCT00908037|OG000|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
10969907|NCT00908037|OG001|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969908|NCT00908037|OG002|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
10969909|NCT00908037|OG003|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969910|NCT00908037|OG004|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
10969911|NCT00908037|OG005|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254301|NCT02582658|OG000|Outcome|ABBVIE REGIMEN +/- Ribavirin (RBV)|ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
11254302|NCT02582658|EG000|Reported Event|ABBVIE REGIMEN +/- Ribavirin (RBV)|ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
10969912|NCT00908037|OG000|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
11254303|NCT02582671|BG000|Baseline|Participants With HCV Genotype 1|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254304|NCT02582671|FG000|Participant Flow|Participants With HCV Genotype 1|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254305|NCT02582671|OG000|Outcome|Participants With HCV Genotype 1|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254306|NCT02582671|EG000|Reported Event|Participants Who Did Not Receive Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily)
11254307|NCT02582671|EG001|Reported Event|Participants Who Received Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11254308|NCT02582684|BG000|Baseline|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
11254309|NCT02582684|FG000|Participant Flow|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
11254310|NCT02582684|OG000|Outcome|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
11254311|NCT02582684|EG000|Reported Event|Arm 1: DTG 50 MG + 3TC 300 mg|"Dolutegravir: Participants were prescribed 50 mg of DTG orally daily~Lamivudine: Participants were prescribed 300 mg of 3TC orally daily."
11254312|NCT02582814|BG000|Baseline|Dapagliflozin 5mg + Insulin|dapagliflozin tablet 5mg + adjustable insulin
11254313|NCT02582814|BG001|Baseline|Dapagliflozin 10mg + Insulin|dapagliflozin tablet 10mg + adjustable insulin
11254314|NCT02582814|BG002|Baseline|Total|Total of all reporting groups
10969913|NCT00908037|OG001|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969914|NCT00908037|OG000|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254315|NCT02582814|FG000|Participant Flow|Dapagliflozin 5mg + Insulin|dapagliflozin tablet 5mg + adjustable insulin
11254316|NCT02582814|FG001|Participant Flow|Dapagliflozin 10mg + Insulin|dapagliflozin tablet 10mg + adjustable insulin
11254317|NCT02582814|OG000|Outcome|Dapagliflozin 5mg + Insulin|dapagliflozin tablet 5mg + adjustable insulin
11254318|NCT02582814|OG001|Outcome|Dapagliflozin 10mg + Insulin|dapagliflozin tablet 10mg + adjustable insulin
11254319|NCT02582814|EG000|Reported Event|Dapagliflozin 5mg + Insulin|dapagliflozin tablet 5mg + adjustable insulin
11254320|NCT02582814|EG001|Reported Event|Dapagliflozin 10mg + Insulin|dapagliflozin tablet 10mg + adjustable insulin
11254321|NCT02582840|BG000|Baseline|Placebo + Insulin|Placebo administered orally once daily in the morning.
11254322|NCT02582840|BG001|Baseline|Dapagliflozin 5mg + Insulin|Dapagliflozin 5 mg administered orally once daily in the morning.
11254323|NCT02582840|BG002|Baseline|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg administered orally once daily in the morning.
11254324|NCT02582840|BG003|Baseline|Total|Total of all reporting groups
11254325|NCT02582840|FG000|Participant Flow|Placebo + Insulin|Placebo administered orally once daily in the morning.
11254326|NCT02582840|FG001|Participant Flow|Dapagliflozin 5mg + Insulin|Dapagliflozin 5 mg administered orally once daily in the morning.
11254327|NCT02582840|FG002|Participant Flow|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg administered orally once daily in the morning.
11254328|NCT02582840|OG000|Outcome|Dapagliflozin 5mg + Insulin|Dapagliflozin 5 mg administered orally once daily in the morning.
11254329|NCT02582840|OG001|Outcome|Dapagliflozin 10mg + Insulin|Dapagliflozin 10 mg administered orally once daily in the morning.
11254330|NCT02582840|OG000|Outcome|Placebo + Insulin|Placebo administered orally once daily in the morning.
11254331|NCT02582840|OG001|Outcome|Dapagliflozin 5mg+ Insulin|Dapagliflozin 5 mg administered orally once daily in the morning.
11254332|NCT02582840|OG002|Outcome|Dapagliflozin 10mg + Insulin|Dapagliflozin 10 mg administered orally once daily in the morning.
11254333|NCT02582840|EG000|Reported Event|Placebo + Insulin|Placebo administered orally once daily in the morning.
11254334|NCT02582840|EG001|Reported Event|Dapagliflozin 5mg + Insulin|Dapagliflozin 5 mg administered orally once daily in the morning.
11254335|NCT02582840|EG002|Reported Event|Dapagliflozin 10 mg + Insulin|Dapagliflozin 10 mg administered orally once daily in the morning.
11254336|NCT02582866|BG000|Baseline|Lacosamide|"Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.~Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks."
11254337|NCT02582866|FG000|Participant Flow|Lacosamide|"Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.~Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks."
11286487|NCT02888756|FG000|Participant Flow|iHIVARNA-01|"Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval~iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption~TriMix: Therapeutic vaccination, followed by treatment interruption"
11254338|NCT02582866|OG000|Outcome|Lacosamide (SS)|"Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.~Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.~Participants formed the Safety Set (SS)."
11254339|NCT02582866|EG000|Reported Event|Lacosamide (SS)|"Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.~Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.~Participants formed the Safety Set (SS)."
11254340|NCT02582970|BG000|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
11254341|NCT02582970|FG000|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
11254342|NCT02582970|OG000|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
11254343|NCT02582970|EG000|Reported Event|Bevacizumab + Chemotherapy|Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
11254344|NCT02582983|BG000|Baseline|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
11254345|NCT02582983|FG000|Participant Flow|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
11254346|NCT02582983|OG000|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
11254347|NCT02582983|EG000|Reported Event|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
11254348|NCT02583230|BG000|Baseline|MedLink|"For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
10969915|NCT00908037|OG001|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254349|NCT02583230|FG000|Participant Flow|MedLink|"For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11254350|NCT02583230|OG000|Outcome|MedLink|"For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11286488|NCT02888756|FG001|Participant Flow|TriMix|"Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval~TriMix: Therapeutic vaccination, followed by treatment interruption"
11286489|NCT02888756|FG002|Participant Flow|Placebo|"Water for injection 3 vaccinations, two weeks interval~Placebo: Therapeutic vaccination, followed by treatment interruption"
11286490|NCT02888756|OG000|Outcome|iHIVARNA-01|"Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval~iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption~TriMix: Therapeutic vaccination, followed by treatment interruption"
11254351|NCT02583230|EG000|Reported Event|MedLink|"For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.~MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
11254352|NCT02583256|BG000|Baseline|aQIV/aQIV|"Subjects previously vaccinated with aQIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254353|NCT02583256|BG001|Baseline|aQIV/QIV|"Subjects previously vaccinated with aQIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254354|NCT02583256|BG002|Baseline|QIV/aQIV|"Subjects previously vaccinated with QIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254355|NCT02583256|BG003|Baseline|QIV/QIV|"Subjects previously vaccinated with QIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254356|NCT02583256|BG004|Baseline|Total|Total of all reporting groups
11254357|NCT02583256|FG000|Participant Flow|aQIV/aQIV|"Subjects previously vaccinated with aQIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254358|NCT02583256|FG001|Participant Flow|aQIV/QIV|"Subjects previously vaccinated with aQIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254359|NCT02583256|FG002|Participant Flow|QIV/aQIV|"Subjects previously vaccinated with QIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254360|NCT02583256|FG003|Participant Flow|QIV/QIV|"Subjects previously vaccinated with QIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254361|NCT02583256|OG000|Outcome|aQIV/aQIV|"Subjects previously vaccinated with aQIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254362|NCT02583256|OG001|Outcome|aQIV/QIV|"Subjects previously vaccinated with aQIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254363|NCT02583256|OG000|Outcome|QIV/aQIV|"Subjects previously vaccinated with QIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254364|NCT02583256|OG001|Outcome|QIV/QIV|"Subjects previously vaccinated with QIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254365|NCT02583256|OG002|Outcome|QIV/aQIV|"Subjects previously vaccinated with QIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254366|NCT02583256|OG003|Outcome|QIV/QIV|"Subjects previously vaccinated with QIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254367|NCT02583256|EG000|Reported Event|aQIV-aQIV|"Subjects previously vaccinated with aQIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254368|NCT02583256|EG001|Reported Event|aQIV-QIV|"Subjects previously vaccinated with aQIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
11254369|NCT02583256|EG002|Reported Event|QIV-aQIV|"Subjects previously vaccinated with QIV followed one year later by aQIV~Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)"
11254370|NCT02583256|EG003|Reported Event|QIV-QIV|"Subjects previously vaccinated with QIV followed one year later by QIV~Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)"
10969916|NCT00908037|OG002|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254371|NCT02583360|BG000|Baseline|Study|"Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.~Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy"
11254372|NCT02583360|BG001|Baseline|Control|Eligible subjects who had VFSS alone with provider recommendations from the same single center.
11254373|NCT02583360|BG002|Baseline|Total|Total of all reporting groups
11254374|NCT02583360|FG000|Participant Flow|Study|"Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.~Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy"
11254375|NCT02583360|FG001|Participant Flow|Control|Eligible subjects who had VFSS alone with provider recommendations from the same single center.
11254376|NCT02583360|OG000|Outcome|Study|"Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.~Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy"
11254377|NCT02583360|OG001|Outcome|Control|Eligible subjects who had VFSS alone with provider recommendations from the same single center.
11254378|NCT02583360|EG000|Reported Event|Study|"Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.~Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy"
11254379|NCT02583360|EG001|Reported Event|Control|Eligible subjects who had VFSS alone with provider recommendations from the same single center.
11254380|NCT02583399|BG000|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg~Ibuprofen: Ibuprofen, 10 mg/kg"
11254381|NCT02583399|FG000|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg~Ibuprofen: Ibuprofen, 10 mg/kg"
11254382|NCT02583399|OG000|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~Ibuprofen: Ibuprofen, 10 mg/kg"
11254383|NCT02583399|EG000|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg~Ibuprofen: Ibuprofen, 10 mg/kg"
11254384|NCT02583425|BG000|Baseline|DFN-11|DFN-11 Injection upon occurrence of migraine
11254385|NCT02583425|FG000|Participant Flow|DFN-11|DFN-11 Injection upon occurrence of migraine
11254386|NCT02583425|OG000|Outcome|DFN-11|"DFN-11 Injection upon occurrence of migraine headache~DFN-11 Injection"
11254387|NCT02583425|OG000|Outcome|DFN-11|"DFN-11 Injection upon occurrence of migraine~DFN-11 Injection"
11254388|NCT02583425|EG000|Reported Event|DFN-11|DFN-11 Injection upon occurrence of migraine
11254389|NCT02583477|BG000|Baseline|Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)|Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m^2 IV infusion followed by gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254390|NCT02583477|BG001|Baseline|Cohort 2 (MEDI4736 + AZD5069)|Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254391|NCT02583477|BG002|Baseline|Total|Total of all reporting groups
11254392|NCT02583477|FG000|Participant Flow|Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)|Participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who were treatment naive received MEDI4736 1.5 gram (g) intravenous (IV) infusion on Day 1 of each 28-day cycle (q4w). Participants also received nab-paclitaxel 125 milligram per meter square (mg/m^2) IV infusion followed by gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed progressive disease (PD) unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254393|NCT02583477|FG001|Participant Flow|Cohort 2 (MEDI4736 + AZD5069)|Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally twice daily (bid). The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254394|NCT02583477|OG000|Outcome|Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)|Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m^2 IV infusion followed by gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254395|NCT02583477|OG001|Outcome|Cohort 2 (MEDI4736 + AZD5069)|Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254396|NCT02583477|OG000|Outcome|Cohort 2 (MEDI4736 + AZD5069)|Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254397|NCT02583477|EG000|Reported Event|Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)|Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m^2 IV infusion followed by gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254398|NCT02583477|EG001|Reported Event|Cohort 2 (MEDI4736 + AZD5069)|Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
11254399|NCT02583711|BG000|Baseline|Healthy Cohort|Normal healthy cohort not undergoing colorectal surgical management
11254400|NCT02583711|BG001|Baseline|Patients Wearing WAM Pre-op and Post-op on the Ward|Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge
11254401|NCT02583711|BG002|Baseline|Patients Who Wore WAM Pre-op, Post-op on the Ward and Home|Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
11254402|NCT02583711|BG003|Baseline|Total|Total of all reporting groups
11254403|NCT02583711|FG000|Participant Flow|Healthy Cohort|Normal healthy cohort not undergoing colorectal surgical management
11254404|NCT02583711|FG001|Participant Flow|Patients Wearing WAM Pre-op and Post-op on the Ward|Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge
11254405|NCT02583711|FG002|Participant Flow|Patients Who Wore WAM Pre-op, Post-op on the Ward and Home|Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
11254406|NCT02583711|OG000|Outcome|Healthy Cohort|Normal healthy cohort not undergoing colorectal surgical management
11254407|NCT02583711|OG001|Outcome|Patients Wearing WAM Pre-op and Post-op on the Ward|Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge
11254408|NCT02583711|OG002|Outcome|Patients Who Wore WAM Pre-op, Post-op on the Ward and Home|Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
11254409|NCT02583711|OG000|Outcome|Patients Wearing WAM Pre-op and Post-op on the Ward|Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge
11254410|NCT02583711|OG001|Outcome|Patients Who Wore WAM Pre-op, Post-op on the Ward and Home|Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
11254411|NCT02583711|EG000|Reported Event|Healthy Cohort|Normal healthy cohort not undergoing colorectal surgical management
11254412|NCT02583711|EG001|Reported Event|Patients Wearing WAM Pre-op and Post-op on the Ward|Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge
11254413|NCT02583711|EG002|Reported Event|Patients Who Wore WAM Pre-op, Post-op on the Ward and Home|Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
11254414|NCT02584140|BG000|Baseline|AEGIS|"All participants will be assigned to this arm of the study.~Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.~Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.~Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis."
11254415|NCT02584140|FG000|Participant Flow|AEGIS|"All participants will be assigned to this arm of the study.~Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.~Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.~Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis."
11254416|NCT02584140|OG000|Outcome|AEGIS|"All participants will be assigned to this arm of the study.~Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.~Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.~Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis."
11254417|NCT02584140|EG000|Reported Event|AEGIS|"All participants will be assigned to this arm of the study.~Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.~Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.~Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis."
11254418|NCT02584257|BG000|Baseline|Safety Population|All randomized patients who received a dose of any of the randomized study medications. Patient baseline characteristics are not designated by treatment arms due to the crossover design of the study (treatment groups are not mutually exclusive).
11254419|NCT02584257|FG000|Participant Flow|PBO-R90-T180-R180-T90|Subjects received PBO in period 1 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 2 (1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 3 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R180 in period 4 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 5 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols)
11286491|NCT02888756|OG001|Outcome|TriMix|"Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval~TriMix: Therapeutic vaccination, followed by treatment interruption"
11286492|NCT02888756|OG002|Outcome|Placebo|"Water for injection 3 vaccinations, two weeks interval~Placebo: Therapeutic vaccination, followed by treatment interruption"
11254420|NCT02584257|FG001|Participant Flow|R90-R180-PBO-T90-T180|Subjects received R90 in period 1 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 2 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 3 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 4 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), T180 in period 5 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols)
11254421|NCT02584257|FG002|Participant Flow|R180-T90-R90-T180-PBO|Subjects received R180 in period 1 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 2 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R90 in period 3 (1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 4 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), PBO in period 5 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)
11254422|NCT02584257|FG003|Participant Flow|T90-T180-R180-PBO-R90|Subjects received T90 in period 1 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), T180 in period 2 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R180 in period 3 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 4 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 5 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)
11254423|NCT02584257|FG004|Participant Flow|T180-PBO-T90-R90-R180|Subjects received T180 in period 1 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), PBO in period 2 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 3 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R90 in period 4 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 5 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)
11254424|NCT02584257|FG005|Participant Flow|T90-R180-T180-R90-PBO|Subjects received T90 in period 1 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R180 in period 2 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 3 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R90 in period 4 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 5 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)
11254425|NCT02584257|FG006|Participant Flow|T180-T90-PBO-R180-R90|Subjects received T180 in period 1 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), T90 in period 2 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), PBO in period 3 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 4 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 5 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)
11254426|NCT02584257|FG007|Participant Flow|R90-PBO-R180-T180-T90|Subjects received R90 in period 1 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 2 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 3 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 4 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), T90 in period 5 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols)
11286493|NCT02888756|EG000|Reported Event|iHIVARNA-01|"Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval~iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption~TriMix: Therapeutic vaccination, followed by treatment interruption"
11254427|NCT02584257|FG008|Participant Flow|R180-R90-T90-PBO-T180|Subjects received R180 in period 1 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 2 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 3 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), PBO in period 4 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 5 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols),
11254428|NCT02584257|OG000|Outcome|Placebo Dose|"Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~placebo ProAir HFA~placebo Lupin albuterol HFA MDI N=82"
11254429|NCT02584257|OG001|Outcome|90 mcg ProAir HFA|"90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~placebo ProAir HFA~ProAir HFA~placebo Lupin albuterol HFA MDI"
11254430|NCT02584257|OG002|Outcome|180 mcg ProAir HFA|"180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~ProAir HFA~placebo Lupin albuterol HFA MDI"
11254431|NCT02584257|OG003|Outcome|90 mcg Lupin Albuterol HFA MDI|"90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols~methacholine chloride~placebo ProAir HFA~Lupin albuterol HFA MDI~placebo Lupin albuterol HFA MDI"
11254432|NCT02584257|OG004|Outcome|180 mcg Lupin Albuterol HFA MDI|"180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols~methacholine chloride~placebo ProAir HFA~Lupin albuterol HFA MDI"
11254433|NCT02584257|EG000|Reported Event|Placebo Dose|"Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~placebo ProAir HFA~placebo Lupin albuterol HFA MDI"
11254434|NCT02584257|EG001|Reported Event|90 mcg ProAir HFA|"90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~placebo ProAir HFA~ProAir HFA~placebo Lupin albuterol HFA MDI"
11254435|NCT02584257|EG002|Reported Event|180 mcg ProAir HFA|"180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols~methacholine chloride~ProAir HFA~placebo Lupin albuterol HFA MDI"
11254436|NCT02584257|EG003|Reported Event|90 mcg Lupin Albuterol HFA MDI|"90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols~methacholine chloride~placebo ProAir HFA~Lupin albuterol HFA MDI~placebo Lupin albuterol HFA MDI"
11254437|NCT02584257|EG004|Reported Event|180 mcg Lupin Albuterol HFA MDI|"180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols~methacholine chloride~placebo ProAir HFA~Lupin albuterol HFA MDI"
11254438|NCT02584452|BG000|Baseline|Continuous Adductor Canal Nerve Catheter|"Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter~Normal Saline as bolus followed by bupivacaine: normal"
11254439|NCT02584452|BG001|Baseline|Long Acting Single Bolus Adductor Canal Nerve Block|"Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal nerve block: ultrasound guided adductor canal nerve block~ropivacaine and dexamethasone: 10cc of 0.5% ropiv"
11254440|NCT02584452|BG002|Baseline|Total|Total of all reporting groups
11254441|NCT02584452|FG000|Participant Flow|Continuous Adductor Canal Nerve Catheter|Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Patients then undergo general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction with propofol bolus and placement of laryngeal mask airway. Intraoperative opioid limited to no > 150mcg of fentanyl. Completion of procedure, dressing and LMA revoved with patients transferred to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.
11254442|NCT02584452|FG001|Participant Flow|Long Acting Single Bolus Adductor Canal Nerve Block|Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Patients then undergo general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no > 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc.
11254443|NCT02584452|OG000|Outcome|Continuous Adductor Canal Nerve Catheter|"Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter~Normal Saline as bolus followed by bupivacaine: normal"
11254444|NCT02584452|OG001|Outcome|Long- Acting Single Bolus Adductor Canal Nerve Block|"Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal nerve block: ultrasound guided adductor canal nerve block~ropivacaine and dexamethasone: 10cc of 0.5% ropiv"
11254445|NCT02584452|OG001|Outcome|Long-Acting Single Bolus Adductor Canal Nerve Block|"Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal nerve block: ultrasound guided adductor canal nerve block~ropivacaine and dexamethasone: 10cc of 0.5% ropiv"
11254446|NCT02584452|EG000|Reported Event|Continuous Adductor Canal Nerve Catheter|"Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter~Normal Saline as bolus followed by bupivacaine: normal"
11254447|NCT02584452|EG001|Reported Event|Long Acting Single Bolus Adductor Canal Nerve Block|"Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.~Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time.~adductor canal nerve block: ultrasound guided adductor canal nerve block~ropivacaine and dexamethasone: 10cc of 0.5% ropiv"
11254448|NCT02584504|BG000|Baseline|Alirocumab 150 mg Q4W|In DBTP, participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254449|NCT02584504|BG001|Baseline|Alirocumab 150 mg Q2W|In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11286494|NCT02888756|EG001|Reported Event|TriMix|"Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval~TriMix: Therapeutic vaccination, followed by treatment interruption"
11254450|NCT02584504|BG002|Baseline|Placebo Q2W|In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254451|NCT02584504|BG003|Baseline|Total|Total of all reporting groups
11254452|NCT02584504|FG000|Participant Flow|Alirocumab 150 mg Q4W|In double-blind treatment period (DBTP), participants received Alirocumab 150 mg subcutaneous (SC) injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin Lipid-Modifying Therapy (LMT) or diet therapy alone for 12 weeks. Participants who completed DBTP, entered in open-label treatment period (OLTP) and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg every 2 weeks (Q2W) at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254453|NCT02584504|FG001|Participant Flow|Alirocumab 150 mg Q2W|In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254454|NCT02584504|FG002|Participant Flow|Placebo Q2W|In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254455|NCT02584504|OG000|Outcome|Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
11254456|NCT02584504|OG001|Outcome|Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
11254457|NCT02584504|OG002|Outcome|Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
11254458|NCT02584504|OG000|Outcome|Alirocumab 150mgQ4W/Up Q2W(After Alirocumab 150mgQ4W in DBTP)|Participants who received alirocumab 150 mg Q4W during DBTP and completed DBTP, entered in OLTP and received alirocumab 150 mg Q4W from Week 12 up to Week 64. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254459|NCT02584504|OG001|Outcome|Alirocumab 150mgQ4W/Up Q2W(After Alirocumab 150mgQ2W in DBTP)|Participants who received alirocumab 150 mg Q2W during DBTP and completed DBTP, entered in OLTP and received alirocumab 150 mg Q4W from Week 12 up to Week 64. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254460|NCT02584504|OG002|Outcome|Alirocumab 150mg Q4W/Up Q2W (After Placebo Q2W in DBTP)|Participants who received Placebo Q2W during DBTP and completed DBTP, entered in OLTP and received alirocumab 150 mg Q4W from Week 12 up to Week 64. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254461|NCT02584504|EG000|Reported Event|Double-blind Treatment Period: Placebo Q2W|Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.
11254462|NCT02584504|EG001|Reported Event|Double-blind Treatment Period: Alirocumab 150 mg Q4W|Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily) stable non-statin LMT or diet therapy alone for 12 weeks.
11254463|NCT02584504|EG002|Reported Event|Double-blind Treatment Period: Alirocumab 150 mg Q2W|Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.
11254464|NCT02584504|EG003|Reported Event|Open-label Treatment Period: Alirocumab 150 mg Q4W/Up Q2W|All participants received alirocumab 150 mg Q4W from the start of the open-label treatment period. Alirocumab dose up-titrated from 150 mg Q4W to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
11254465|NCT02584608|BG000|Baseline|Treatment|"ACTIMMUNE 50 µg/m2 subcutaneously three times per week (TIW) for 8 weeks~ACTIMMUNE"
11254466|NCT02584608|FG000|Participant Flow|Treatment|"ACTIMMUNE 50 µg/m2 subcutaneously three times per week (TIW) for 8 weeks~ACTIMMUNE"
11254467|NCT02584608|OG000|Outcome|Treatment|"ACTIMMUNE 50 µg/m2 subcutaneously three times per week (TIW) for 8 weeks~ACTIMMUNE"
11254468|NCT02584608|EG000|Reported Event|Treatment|"ACTIMMUNE 50 µg/m2 subcutaneously three times per week (TIW) for 8 weeks~ACTIMMUNE"
11254469|NCT02584660|BG000|Baseline|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
11254470|NCT02584660|BG001|Baseline|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
11254471|NCT02584660|BG002|Baseline|Total|Total of all reporting groups
11254472|NCT02584660|FG000|Participant Flow|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
11254473|NCT02584660|FG001|Participant Flow|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
11254474|NCT02584660|OG000|Outcome|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
11254475|NCT02584660|OG001|Outcome|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
11254476|NCT02584660|EG000|Reported Event|Rivaroxaban|Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
11254477|NCT02584660|EG001|Reported Event|Standard-of-care|Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
11254478|NCT02584673|BG000|Baseline|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11254479|NCT02584673|BG001|Baseline|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11254480|NCT02584673|BG002|Baseline|Total|Total of all reporting groups
11254481|NCT02584673|FG000|Participant Flow|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11254482|NCT02584673|FG001|Participant Flow|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11254483|NCT02584673|OG000|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11254484|NCT02584673|OG001|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11254485|NCT02584673|EG000|Reported Event|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11254486|NCT02584673|EG001|Reported Event|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11254487|NCT02584686|BG000|Baseline|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
11254488|NCT02584686|BG001|Baseline|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
11254489|NCT02584686|BG002|Baseline|Total|Total of all reporting groups
11254490|NCT02584686|FG000|Participant Flow|Study Group|"The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
11254491|NCT02584686|FG001|Participant Flow|Control Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
11254492|NCT02584686|OG000|Outcome|(BTX) A|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
11254493|NCT02584686|OG001|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
11286495|NCT02888756|EG002|Reported Event|Placebo|"Water for injection 3 vaccinations, two weeks interval~Placebo: Therapeutic vaccination, followed by treatment interruption"
11254494|NCT02584686|OG000|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
11254495|NCT02584686|EG000|Reported Event|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
11254496|NCT02584686|EG001|Reported Event|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
11254497|NCT02584725|BG000|Baseline|5 mg/kg/Dose Tranexamic Acid|5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254498|NCT02584725|BG001|Baseline|10 mg/kg/Dose Tranexamic Acid|10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254499|NCT02584725|BG002|Baseline|15 mg/kg/Dose Tranexamic Acid|15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254500|NCT02584725|BG003|Baseline|Total|Total of all reporting groups
11254501|NCT02584725|FG000|Participant Flow|5 mg/kg/Dose Tranexamic Acid|5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254502|NCT02584725|FG001|Participant Flow|10 mg/kg/Dose Tranexamic Acid|10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254503|NCT02584725|FG002|Participant Flow|15 mg/kg/Dose Tranexamic Acid|15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254504|NCT02584725|OG000|Outcome|5 mg/kg/Dose Tranexamic Acid|5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254505|NCT02584725|OG001|Outcome|10 mg/kg/Dose Tranexamic Acid|10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254506|NCT02584725|OG002|Outcome|15 mg/kg/Dose Tranexamic Acid|15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254507|NCT02584725|EG000|Reported Event|5 mg/kg/Dose Tranexamic Acid|5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
10969917|NCT00908037|OG000|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254508|NCT02584725|EG001|Reported Event|10 mg/kg/Dose Tranexamic Acid|10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254509|NCT02584725|EG002|Reported Event|15 mg/kg/Dose Tranexamic Acid|15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
11254510|NCT02584790|BG000|Baseline|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
11254511|NCT02584790|FG000|Participant Flow|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
11254512|NCT02584790|OG000|Outcome|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
11254513|NCT02584790|EG000|Reported Event|Post Radiotherapy 8 Weeks NPC Patient|"All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system~Laryngoscope with NBI system: All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system"
11254514|NCT02584855|BG000|Baseline|Ixekizumab Open Label|Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
11254515|NCT02584855|FG000|Participant Flow|Ixekizumab Open Label|Open-Label Treatment Period (OLTP): Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (Week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
11254516|NCT02584855|FG001|Participant Flow|IXE80Q2W Non-randomized|"Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.~Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period."
11254517|NCT02584855|FG002|Participant Flow|Ixekizumab|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse)."
11254518|NCT02584855|FG003|Participant Flow|Placebo|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)"
11254519|NCT02584855|FG004|Participant Flow|IXE80Q2W Post-Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
11254520|NCT02584855|FG005|Participant Flow|Placebo Post-Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
11254521|NCT02584855|OG000|Outcome|Ixekizumab|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse)."
11254522|NCT02584855|OG001|Outcome|Placebo|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)"
11254523|NCT02584855|OG001|Outcome|Placebo|Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).
11254524|NCT02584855|OG000|Outcome|Ixekizumab Open Label|Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
11254525|NCT02584855|EG000|Reported Event|Ixekizumab Open Label|Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
11254526|NCT02584855|EG001|Reported Event|Ixekizumab|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse)."
11254527|NCT02584855|EG002|Reported Event|Placebo|"Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.~Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)."
11254528|NCT02584855|EG003|Reported Event|IXE80Q2W Non-randomized Population to Withdrawal Period|"Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.~Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period."
11254529|NCT02584855|EG004|Reported Event|IXE80Q2W Relapse Period|"IXE80Q2W Relapse Period~Double Blind Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).~Double Blind Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)."
11254530|NCT02584855|EG005|Reported Event|IXE80Q2W Post-Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
11254531|NCT02584855|EG006|Reported Event|Placebo Post-Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
11254532|NCT02584868|BG000|Baseline|Saline Colloid|6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
11254533|NCT02584868|BG001|Baseline|Balanced Colloid|6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
11254534|NCT02584868|BG002|Baseline|Total|Total of all reporting groups
11254535|NCT02584868|FG000|Participant Flow|Saline Colloid|6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
11254536|NCT02584868|FG001|Participant Flow|Balanced Colloid|6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
11254537|NCT02584868|OG000|Outcome|Saline Colloid|6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
11254538|NCT02584868|OG001|Outcome|Balanced Colloid|6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
11254539|NCT02584868|EG000|Reported Event|Saline Colloid|6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
11254540|NCT02584868|EG001|Reported Event|Balanced Colloid|6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
11254541|NCT02584959|BG000|Baseline|Experimental/Placebo|Subjects will be randomized to receive C1 Esterase Inhibitor in the 1st Treatment period and then switch to Placebo in the 2nd treatment period.
11254542|NCT02584959|BG001|Baseline|Placebo/Experimental|Subjects will be randomized to receive a placebo treatment in the 1st Treatment period and then switch to receive C1 Esterase Inhibitor in the 2nd treatment period.
11254543|NCT02584959|BG002|Baseline|Experimental/ Experimental|Subjects will be randomized and receive C1 Esterase Inhibitor in both 1st as well as the 2nd treatment period
11254544|NCT02584959|BG003|Baseline|Total|Total of all reporting groups
11254545|NCT02584959|FG000|Participant Flow|Experimental/Placebo|Participants were randomized to receive C1 Esterase Inhibitor in the 1st treatment period and then switched to Placebo in the 2nd treatment period.
11254546|NCT02584959|FG001|Participant Flow|Placebo/Experimental|Participants were randomized to receive placebo treatment in the 1st treatment period and then switched to receive C1 Esterase Inhibitor in the 2nd treatment period.
11254547|NCT02584959|FG002|Participant Flow|Experimental/ Experimental|Participants were randomized to receive C1 Esterase Inhibitor in both 1st as well as the 2nd treatment period.
11254548|NCT02584959|OG000|Outcome|Treatment C1 INH|Participants who received C1 Esterase Inhibitor (C1 INH) treatment (in period 1 of the Experimental/Placebo arm and in period 2 of the Placebo/Experimental arm).
11254549|NCT02584959|OG001|Outcome|Treatment Placebo|Participants who received Placebo treatment (in period 2 of the Experimental/Placebo arm and in period 1 of the Placebo/Experimental arm).
11254550|NCT02584959|OG000|Outcome|Full Analysis Set|Including all participants in the cross-over sequences who had data in both treatment periods and who received at least one dose of C1 Esterase Inhibitor and had at least 1 post-baseline primary efficacy assessment.
11254551|NCT02584959|OG000|Outcome|Full Analysis Data Set|Including all participants in the cross-over sequences who had data in both treatment periods and who received at least one dose of C1 Esterase Inhibitor and had at least 1 post-baseline primary efficacy assessment.
11254552|NCT02584959|OG000|Outcome|Treatment C1 INH|Participants who received C1 Esterase Inhibitor (C1 INH) treatment (in period 1 of the Experimental/Placebo arm, in period 2 of the Placebo/Experimental arm and in period 1 and 2 of the Experimental/Experimental arm).
11254553|NCT02584959|OG000|Outcome|Treatment Placebo|Participants who received Placebo treatment (in period 2 of the Experimental/Placebo arm and in period 1 of the Placebo/Experimental arm).
11254554|NCT02584959|OG001|Outcome|Treatment Placebo|Participants who received Placebo treatment (in period 2 of the Experimental/Placebo arm and in period 1 of the Placebo/Experimental arm)..
11254555|NCT02584959|OG000|Outcome|Experimental/Placebo Arm - Treatment C1 INH|Participants randomized to the Experimental/Placebo arm received C1 Esterase Inhibitor (C1 INH) in treatment period 1.
11254556|NCT02584959|OG001|Outcome|Experimental/Placebo Arm - Treatment Placebo|Participants randomized to the Experimental/Placebo arm received Placebo in treatment period 2.
11254557|NCT02584959|OG002|Outcome|Placebo/Experimental Arm - Treatment Placebo|Participants randomized to the Placebo/Experimental arm received Placebo in treatment period 1.
11254558|NCT02584959|OG003|Outcome|Placebo/Experimental Arm - Treatment C1 INH|Participants randomized to the Placebo/Experimental arm received C1 Esterase Inhibitor (C1 INH) in treatment period 2.
11254559|NCT02584959|OG004|Outcome|Experimental/Experimental Arm - Period 1 Treatment C1 INH|Participants randomized to the Experimental/Experimental arm received C1 Esterase Inhibitor (C1 INH) in treatment period 1.
11254560|NCT02584959|OG005|Outcome|Experimental/Experimental Arm - Period 2 Treatment C1 INH|Participants randomized to the Experimental/Experimental arm received C1 Esterase Inhibitor (C1 INH) in treatment period 2.
11254561|NCT02584959|EG000|Reported Event|Treatment C1 INH|Participants who received C1 Esterase Inhibitor (C1 INH) treatment (in period 1 of the Experimental/Placebo arm, in period 2 of the Placebo/Experimental arm and in period 1 and 2 of the Experimental/Experimental arm).
11254562|NCT02584959|EG001|Reported Event|Treatment Placebo|Participants who received Placebo treatment (in period 2 of the Experimental/Placebo arm and in period 1 of the Placebo/Experimental arm).
11254563|NCT02584998|BG000|Baseline|Usual Care|These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
11254564|NCT02584998|BG001|Baseline|Screening Invitation-reminder|"Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).~Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm"
11254565|NCT02584998|BG002|Baseline|Mailed-FIT|"Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).~Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample."
11254566|NCT02584998|BG003|Baseline|Total|Total of all reporting groups
11254567|NCT02584998|FG000|Participant Flow|Usual Care|These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
11254568|NCT02584998|FG001|Participant Flow|Screening Invitation-reminder|"Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).~Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm"
11254569|NCT02584998|FG002|Participant Flow|Mailed-FIT|"Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).~Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample."
11254570|NCT02584998|OG000|Outcome|Usual Care|These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
11254571|NCT02584998|OG001|Outcome|Screening Invitation-reminder|"Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).~Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm"
11254572|NCT02584998|OG002|Outcome|Mailed-FIT|"Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).~Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample."
11254573|NCT02584998|EG000|Reported Event|Usual Care|These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
11254574|NCT02584998|EG001|Reported Event|Screening Invitation-reminder|"Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).~Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm"
11254575|NCT02584998|EG002|Reported Event|Mailed-FIT|"Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).~Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample."
11254576|NCT02585245|BG000|Baseline|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
11254577|NCT02585245|FG000|Participant Flow|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
11254578|NCT02585245|OG000|Outcome|NRS2002 Nutrition Risk Screen|Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
11254579|NCT02585245|OG001|Outcome|ThedaCare RD/RN Nutrition Risk Screen|Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
11254580|NCT02585245|EG000|Reported Event|All Participants|All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
11254581|NCT02585700|BG000|Baseline|Vaccine Group|0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
11254582|NCT02585700|BG001|Baseline|Placebo Group|0.5 mL of phosphate buffered saline
11254583|NCT02585700|BG002|Baseline|Total|Total of all reporting groups
11254584|NCT02585700|FG000|Participant Flow|Vaccine Group|0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
11254585|NCT02585700|FG001|Participant Flow|Placebo Group|0.5 mL of phosphate buffered saline
11254586|NCT02585700|OG000|Outcome|Vaccine Group|0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
11254587|NCT02585700|OG001|Outcome|Placebo Group|0.5 mL of phosphate buffered saline
11254588|NCT02585700|EG000|Reported Event|Vaccine Group|"0.5 mL of influenza vaccine, split, inactivated with 15 mcg of HA of each of 3 strains:~NYMC BX-51B reassortant of B/Massachusetts/2/2012~X-181 reassortant of H1/A/California/7/2009~X-223A reassortant of H3/A/Texas/50/2012."
11254589|NCT02585700|EG001|Reported Event|Placebo Group|0.5 mL of phosphate buffered saline
11254590|NCT02585713|BG000|Baseline|Arm A (Apixaban)|Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
11254591|NCT02585713|BG001|Baseline|Arm B (Dalteparin)|Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
11254592|NCT02585713|BG002|Baseline|Total|Total of all reporting groups
11254593|NCT02585713|FG000|Participant Flow|Arm A (Apixaban)|Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
11254594|NCT02585713|FG001|Participant Flow|Arm B (Dalteparin)|Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
11254595|NCT02585713|OG000|Outcome|Arm A (Apixaban)|Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
11254596|NCT02585713|OG001|Outcome|Arm B (Dalteparin)|Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
11254597|NCT02585713|EG000|Reported Event|Arm A (Apixaban)|Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
11254598|NCT02585713|EG001|Reported Event|Arm B (Dalteparin)|Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
11254599|NCT02585778|BG000|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254600|NCT02585778|BG001|Baseline|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254601|NCT02585778|BG002|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254602|NCT02585778|BG003|Baseline|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254603|NCT02585778|BG004|Baseline|Total|Total of all reporting groups
11254604|NCT02585778|FG000|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable, maximally tolerated dose of statin therapy with or without other lipid-modifying therapy (LMT), insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254605|NCT02585778|FG001|Participant Flow|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254606|NCT02585778|OG000|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254607|NCT02585778|OG001|Outcome|Placebo Q2W: T1DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254608|NCT02585778|OG002|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254609|NCT02585778|OG003|Outcome|Placebo Q2W: T2DM Participants|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254610|NCT02585778|OG000|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254611|NCT02585778|OG001|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254612|NCT02585778|EG000|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11254613|NCT02585778|EG001|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.
11254614|NCT02585830|BG000|Baseline|Observation|Home and in-lab observation
11254615|NCT02585830|FG000|Participant Flow|Adolescent Sleep Observation|Home and in-lab observation of sleep and insulin sensitivity
11254616|NCT02585830|OG000|Outcome|Observation|Home and in-lab observation
11254617|NCT02585830|EG000|Reported Event|Observation|Home and in-lab observation
11254618|NCT02585843|BG000|Baseline|High-dose|"Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days~Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days"
11254619|NCT02585843|BG001|Baseline|Standard of Care|"Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)~Spironolactone 25mg: 25mg/day of spironolactone"
11254620|NCT02585843|BG002|Baseline|Total|Total of all reporting groups
11254621|NCT02585843|FG000|Participant Flow|High-dose|"Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days~Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days"
11254622|NCT02585843|FG001|Participant Flow|Standard of Care|"Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)~Spironolactone 25mg: 25mg/day of spironolactone"
11254623|NCT02585843|OG000|Outcome|High-dose|"Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days~Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days"
11254624|NCT02585843|OG001|Outcome|Standard of Care|"Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)~Spironolactone 25mg: 25mg/day of spironolactone"
11254625|NCT02585843|EG000|Reported Event|High-dose|"Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days~Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days"
11254626|NCT02585843|EG001|Reported Event|Standard of Care|"Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)~Spironolactone 25mg: 25mg/day of spironolactone"
11254627|NCT02585895|BG000|Baseline|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254628|NCT02585895|BG001|Baseline|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254629|NCT02585895|BG002|Baseline|Total|Total of all reporting groups
11254630|NCT02585895|FG000|Participant Flow|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254631|NCT02585895|FG001|Participant Flow|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254632|NCT02585895|OG000|Outcome|Apheresis|Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254633|NCT02585895|OG001|Outcome|Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
11254634|NCT02585895|EG000|Reported Event|Primary Period: Apheresis QW|Participants received apheresis every week (QW) for 6 weeks during the primary period of the study.
11254635|NCT02585895|EG001|Reported Event|Primary Period: Apheresis Q2W|Participants received apheresis every 2 weeks (Q2W) for 6 weeks during the primary period of the study.
11254636|NCT02585895|EG002|Reported Event|Primary Period: Evolocumab|Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study.
11254637|NCT02585895|EG003|Reported Event|Post-primary Period: Apheresis/Evolocumab|Starting at week 6 participants received 140 mg evolocumab Q2W up to week 24.
11254638|NCT02585895|EG004|Reported Event|Post-primary Period: Evolocumab/Evolocumab|Participants received 140 mg evolocumab Q2W from week 6 to week 24.
11254639|NCT02585934|BG000|Baseline|RVT-101|"RVT-101 adjunct to 5 mg or 10 mg donepezil~RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks"
11254640|NCT02585934|BG001|Baseline|Placebo|"Placebo adjunct to 5 mg or 10 mg donepezil~Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks"
11254641|NCT02585934|BG002|Baseline|Total|Total of all reporting groups
11254642|NCT02585934|FG000|Participant Flow|RVT-101|"RVT-101 adjunct to 5 mg or 10 mg donepezil~RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks"
11254643|NCT02585934|FG001|Participant Flow|Placebo|"Placebo adjunct to 5 mg or 10 mg donepezil~Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks"
11254644|NCT02585934|OG000|Outcome|RVT-101|"RVT-101 adjunct to 5 mg or 10 mg donepezil~RVT-101: once daily, oral, 35 mg tablets"
11254645|NCT02585934|OG001|Outcome|Placebo|"Placebo adjunct to 5 mg or 10 mg donepezil~Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet"
11254646|NCT02585934|OG000|Outcome|RVT-101|"RVT-101 adjunct to 5 mg or 10 mg donepezil~RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks"
11254647|NCT02585934|EG000|Reported Event|RVT-101 Treatment|"RVT-101 adjunct to 5 mg or 10 mg donepezil~RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks"
11254648|NCT02585934|EG001|Reported Event|Placebo Treatment|"Placebo adjunct to 5 mg or 10 mg donepezil~Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks"
11254649|NCT02585934|EG002|Reported Event|Screening Period|Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)
11254650|NCT02585934|EG003|Reported Event|Run-In Period|"Placebo adjunct to 5 mg or 10 mg donepezil~Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 3 weeks)"
11254651|NCT02585934|EG004|Reported Event|RVT-101 Post-Treatment|"Subjects reported adverse events after completing the treatment period.~The Post-Treatment period - defined as up to 30 days post-last-dose"
11254652|NCT02585934|EG005|Reported Event|Placebo Post-Treatment|"Subjects reported adverse events after completing the treatment period.~The Post-Treatment period - defined as up to 30 days post-last-dose"
11254653|NCT02585960|BG000|Baseline|BAX 855-Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254654|NCT02585960|BG001|Baseline|BAX 855-High Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
11254655|NCT02585960|BG002|Baseline|BAX 855-Non-randomized|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.
11254656|NCT02585960|BG003|Baseline|Total|Total of all reporting groups
11254657|NCT02585960|FG000|Participant Flow|BAX 855-Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting factor VIII (FVIII) trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of greater than (>) 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254658|NCT02585960|FG001|Participant Flow|BAX 855-High Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
11254659|NCT02585960|FG002|Participant Flow|BAX 855-Non-randomized|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.
11254660|NCT02585960|OG000|Outcome|BAX 855-Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254661|NCT02585960|OG001|Outcome|BAX 855-High Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
11254662|NCT02585960|OG000|Outcome|BAX 855 - Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254663|NCT02585960|OG001|Outcome|BAX 855 - High Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
11254664|NCT02585960|OG000|Outcome|BAX 855-Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254665|NCT02585960|OG002|Outcome|BAX 855-Non-randomized|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.
11254666|NCT02585960|EG000|Reported Event|BAX 855-Low Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
11254667|NCT02585960|EG001|Reported Event|BAX 855-High Level|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
11254668|NCT02585960|EG002|Reported Event|BAX 855-Non-randomized|Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.
11254669|NCT02585999|BG000|Baseline|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
11254670|NCT02585999|FG000|Participant Flow|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
11254671|NCT02585999|OG000|Outcome|Xulane|Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
11254672|NCT02585999|OG000|Outcome|Xulane|"All participants using the Xulane contraceptive patch for 12 continuous weeks~Xulane Contraceptive Patch: Extended use (12 weeks) of contraceptive patch"
11254673|NCT02585999|EG000|Reported Event|Xulane|All participants using the Xulane contraceptive patch for 12 continuous weeks
11254674|NCT02586012|BG000|Baseline|Subjects|All subjects randomized to 1 of 6 possible dosing sequence scenarios based on 3 different weight-based dosing regimens (TBW, LBM, and IBW).
11254675|NCT02586012|FG000|Participant Flow|TBW, LBM, IBW|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on TBW (Total Body Weight); Week 2, the dose will be based on LBM (Lean Body Mass); and Week 3, the dose will be based on IBW (Ideal Body Weight).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254676|NCT02586012|FG001|Participant Flow|LBM, IBW, TBW|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on LBM (Lean Body Mass); Week 2, the dose will be based on IBW (Ideal Body Weight); and Week 3, the dose will be based on TBW (Total Body Weight).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254677|NCT02586012|FG002|Participant Flow|IBW, TBW, LBM|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on IBW (Ideal Body Weight); Week 2, the dose will be based on TBW (Total Body Weight); and Week 3, the dose will be based on LBM (Lean Body Mass).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254678|NCT02586012|FG003|Participant Flow|TBW, IBW, LBM|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on TBW (Total Body Weight); Week 2, the dose will be based on IBW (Ideal Body Weight); and Week 3, the dose will be based on LBM (Lean Body Mass).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254679|NCT02586012|FG004|Participant Flow|LBM, TBW, IBW|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on LBM (Lean Body Mass); Week 2, the dose will be based on TBW (Total Body Weight); and Week 3, the dose will be based on IBW (Ideal Body Weight).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254680|NCT02586012|FG005|Participant Flow|IBW, LBM, TBW|"Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on, IBW (Ideal Body Weight); Week 2, the dose will be based on LBM (Lean Body Mass); and Week 3, the dose will be based on TBW (Total Body Weight).~rFVIII: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)]."
11254681|NCT02586012|OG000|Outcome|Lean Body Mass|Subjects receiving rFVIII based on LBM.
11254682|NCT02586012|OG001|Outcome|Total Body Weight|Subjects receiving rFVIII based on TBW.
11254683|NCT02586012|OG000|Outcome|Ideal Body Weight|Subjects receiving rFVIII based on IBW.
11254684|NCT02586012|OG001|Outcome|Ideal Body Weight|Subjects receiving rFVIII based on IBW.
11254685|NCT02586012|EG000|Reported Event|Total Body Weight|Subjects who received rFVIII based on TBW.
11254686|NCT02586012|EG001|Reported Event|Ideal Body Weight|Subjects who received rFVIII based on IBW.
11254687|NCT02586012|EG002|Reported Event|Lean Body Mass|Subjects who received rFVIII based on LBM.
11254688|NCT02586064|BG000|Baseline|IPT-PTSD|"Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions~Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination."
11254689|NCT02586064|BG001|Baseline|Prolonged Exposure|"Exposure based intervention including exposure to memories and avoided places and activities~Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities)."
11254690|NCT02586064|BG002|Baseline|Total|Total of all reporting groups
11254691|NCT02586064|FG000|Participant Flow|IPT-PTSD|"Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions~Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination."
11254692|NCT02586064|FG001|Participant Flow|Prolonged Exposure|"Exposure based intervention including exposure to memories and avoided places and activities~Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities)."
11254693|NCT02586064|OG000|Outcome|IPT-PTSD|"Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions~Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination."
11254694|NCT02586064|OG001|Outcome|Prolonged Exposure|"Exposure based intervention including exposure to memories and avoided places and activities~Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities)."
11254695|NCT02586064|OG002|Outcome|Difference Mean|Difference between mean of IPT-PTSD and Prolonged Exposure
11254696|NCT02586064|OG000|Outcome|IPT-PTSD|Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction.
11254697|NCT02586064|OG002|Outcome|Difference Between Means|Difference between mean of IPT-PTSD and Prolonged Exposure
11254698|NCT02586064|EG000|Reported Event|IPT-PTSD|"Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions~Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination."
11254699|NCT02586064|EG001|Reported Event|Prolonged Exposure|"Exposure based intervention including exposure to memories and avoided places and activities~Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities)."
11254700|NCT02586077|BG000|Baseline|Exparel|Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
11254701|NCT02586077|FG000|Participant Flow|Exparel|Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
11254702|NCT02586077|OG000|Outcome|Exparel|Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
11254703|NCT02586077|OG000|Outcome|Overall|Data across all patients
11254704|NCT02586077|EG000|Reported Event|Overall|Data across all patients
11254705|NCT02586155|BG000|Baseline|High-Intensity Statin Therapy+RVX000222|"Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Apabetalone: 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
10820315|NCT00056550|BG000|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
10969918|NCT00908037|OG001|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of &lt;=27 kg received 25 mg QD and participants with a body weight of &gt;=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969919|NCT00908037|OG002|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11254706|NCT02586155|BG001|Baseline|High-Intensity Statin Therapy+Placebo|"Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254707|NCT02586155|BG002|Baseline|Total|Total of all reporting groups
11254708|NCT02586155|FG000|Participant Flow|High-Intensity Statin Therapy+RVX000222|"Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Apabetalone: 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254709|NCT02586155|FG001|Participant Flow|High-Intensity Statin Therapy+Placebo|"Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254710|NCT02586155|OG000|Outcome|High-Intensity Statin Therapy+RVX000222|"Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Apabetalone: 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254711|NCT02586155|OG001|Outcome|High-Intensity Statin Therapy+Placebo|"Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254712|NCT02586155|EG000|Reported Event|High-Intensity Statin Therapy+RVX000222|"Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Apabetalone: 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254713|NCT02586155|EG001|Reported Event|High-Intensity Statin Therapy+Placebo|"Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)~Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule~Atorvastatin: High-Intensity Statin~Rosuvastatin: High-Intensity Statin"
11254714|NCT02586233|BG000|Baseline|Cohort 1: DS-1040b 0.6 mg|Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
11254715|NCT02586233|BG001|Baseline|Cohort 2: DS-1040b 1.2 mg|Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
11254716|NCT02586233|BG002|Baseline|Cohort 3: DS-1040b 2.4 mg|Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
11254717|NCT02586233|BG003|Baseline|Cohort 4: DS-1040b 4.8 mg|Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
11254718|NCT02586233|BG004|Baseline|Cohort 5: DS-1040b 7.2 mg|Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
11254719|NCT02586233|BG005|Baseline|Cohort 6: DS-1040b 9.6 mg|Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
11254720|NCT02586233|BG006|Baseline|Placebo|Participants who received a single intravenous infusion of placebo.
11254721|NCT02586233|BG007|Baseline|Total|Total of all reporting groups
11254722|NCT02586233|FG000|Participant Flow|Cohort 1: DS-1040b 0.6 mg|Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
11254723|NCT02586233|FG001|Participant Flow|Cohort 2: DS-1040b 1.2 mg|Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
11254724|NCT02586233|FG002|Participant Flow|Cohort 3: DS-1040b 2.4 mg|Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
11254725|NCT02586233|FG003|Participant Flow|Cohort 4: DS-1040b 4.8 mg|Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
11254726|NCT02586233|FG004|Participant Flow|Cohort 5: DS-1040b 7.2 mg|Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
11254727|NCT02586233|FG005|Participant Flow|Cohort 6: DS-1040b 9.6 mg|Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
11254728|NCT02586233|FG006|Participant Flow|Placebo|Participants who received a single intravenous infusion of placebo.
11254729|NCT02586233|OG000|Outcome|Cohort 1: DS-1040b 0.6 mg|Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
11254730|NCT02586233|OG001|Outcome|Cohort 2: DS-1040b 1.2 mg|Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
11254731|NCT02586233|OG002|Outcome|Cohort 3: DS-1040b 2.4 mg|Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
11254732|NCT02586233|OG003|Outcome|Cohort 4: DS-1040b 4.8 mg|Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
11254733|NCT02586233|OG004|Outcome|Cohort 5: DS-1040b 7.2 mg|Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
10822096|NCT00074490|BG000|Baseline|Arm IVDcohort 1 (Th2 DLI)|Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
11254734|NCT02586233|OG005|Outcome|Cohort 6: DS-1040b 9.6 mg|Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
11254735|NCT02586233|OG006|Outcome|All DS-1040b|All participants who received a single intravenous infusion of DS-1040b.
11254736|NCT02586233|OG007|Outcome|Placebo|Participants who received a single intravenous infusion of placebo.
11254737|NCT02586233|OG005|Outcome|Cohort 6: DS-1040b 9.6 mg (Non-IAT)|Participants who received a single intravenous infusion of DS-1040b 9.6 mg (non-intra-arterial thrombectomy).
11254738|NCT02586233|OG006|Outcome|Placebo|Participants who received a single intravenous infusion of placebo.
11254739|NCT02586233|EG000|Reported Event|Cohort 1: DS-1040b 0.6 mg|Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
11254740|NCT02586233|EG001|Reported Event|Cohort 2: DS-1040b 1.2 mg|Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
11254741|NCT02586233|EG002|Reported Event|Cohort 3: DS-1040b 2.4 mg|Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
11254742|NCT02586233|EG003|Reported Event|Cohort 4: DS-1040b 4.8 mg|Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
11254743|NCT02586233|EG004|Reported Event|Cohort 5: DS-1040b 7.2 mg|Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
11254744|NCT02586233|EG005|Reported Event|Cohort 6: DS-1040b 9.6 mg|Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
11254745|NCT02586233|EG006|Reported Event|All DS-1040b|All participants who received a single intravenous infusion of DS-1040b.
11254746|NCT02586233|EG007|Reported Event|Placebo|Participants who received a single intravenous infusion of placebo.
11254747|NCT02586415|BG000|Baseline|Endovascular Thrombectomy Therapy|"Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.~Devices approved for use in DEFUSE 3:~Trevo Retriever~Solitaire™ FR Revascularization Device~Penumbra thrombectomy system~Covidien MindFrame Capture Revascularization Device~Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system."
11254748|NCT02586415|BG001|Baseline|Medical Management|standard medical therapy alone
10822097|NCT00074490|BG001|Baseline|Arm IVD Cohort 3 (Multiple Th2 DLI)|Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
11254749|NCT02586415|BG002|Baseline|Total|Total of all reporting groups
11254750|NCT02586415|FG000|Participant Flow|Endovascular Thrombectomy Therapy|"Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.~Devices approved for use in DEFUSE 3:~Trevo Retriever~Solitaire™ FR Revascularization Device~Penumbra thrombectomy system~Covidien MindFrame Capture Revascularization Device~Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.~Trevo Retriever: Trevo R"
11254751|NCT02586415|FG001|Participant Flow|Medical Management|standard medical therapy alone
11254752|NCT02586415|OG000|Outcome|Endovascular Thrombectomy Therapy|"Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.~Devices approved for use in DEFUSE 3:~Trevo Retriever~Solitaire™ FR Revascularization Device~Penumbra thrombectomy system~Covidien MindFrame Capture Revascularization Device~Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system."
11254753|NCT02586415|OG001|Outcome|Medical Management|standard medical therapy alone
11254754|NCT02586415|OG000|Outcome|Endovascular Thrombectomy Therapy|Treatment with one or more thrombectomy devices cleared by the FDA for thrombus removal in patients experiencing an acute stroke.
11254755|NCT02586415|EG000|Reported Event|Endovascular Thrombectomy Therapy|"Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.~Devices approved for use in DEFUSE 3:~Trevo Retriever~Solitaire™ FR Revascularization Device~Penumbra thrombectomy system~Covidien MindFrame Capture Revascularization Device~Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system."
11254756|NCT02586415|EG001|Reported Event|Medical Management|standard medical therapy alone
11254757|NCT02586493|BG000|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
11254758|NCT02586493|FG000|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
11254759|NCT02586493|OG000|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
11254760|NCT02586493|EG000|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
11254761|NCT02586506|BG000|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
11254762|NCT02586506|FG000|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
11254763|NCT02586506|OG000|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
11254764|NCT02586506|EG000|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
11254765|NCT02586727|BG000|Baseline|Six Week Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254766|NCT02586727|BG001|Baseline|Treat and Extend Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Patients with decreased radiation maculopathy by one grade or more will extend re-evaluation by two weeks. Patients with increased radiation maculopathy by one grade or more will have re-evaluation decreased by one week. Patients that show no maculopathy grade change will remain at the same re-evaluation interval.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254767|NCT02586727|BG002|Baseline|Total|Total of all reporting groups
11254768|NCT02586727|FG000|Participant Flow|Six Week Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254769|NCT02586727|FG001|Participant Flow|Treat and Extend Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Patients with decreased radiation maculopathy by one grade or more will extend re-evaluation by two weeks. Patients with increased radiation maculopathy by one grade or more will have re-evaluation decreased by one week. Patients that show no maculopathy grade change will remain at the same re-evaluation interval.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254770|NCT02586727|OG000|Outcome|Six Week Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254771|NCT02586727|OG001|Outcome|Treat and Extend Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Patients with decreased radiation maculopathy by one grade or more will extend re-evaluation by two weeks. Patients with increased radiation maculopathy by one grade or more will have re-evaluation decreased by one week. Patients that show no maculopathy grade change will remain at the same re-evaluation interval.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254772|NCT02586727|EG000|Reported Event|Six Week Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254773|NCT02586727|EG001|Reported Event|Treat and Extend Dosing Regimen Arm|"Patients will receive an intravitreal aflibercept injection the first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Patients with decreased radiation maculopathy by one grade or more will extend re-evaluation by two weeks. Patients with increased radiation maculopathy by one grade or more will have re-evaluation decreased by one week. Patients that show no maculopathy grade change will remain at the same re-evaluation interval.~aflibercept: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward."
11254774|NCT02586805|BG000|Baseline|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
11254775|NCT02586805|BG001|Baseline|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254776|NCT02586805|BG002|Baseline|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254777|NCT02586805|BG003|Baseline|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
11254778|NCT02586805|BG004|Baseline|Total|Total of all reporting groups
11254779|NCT02586805|FG000|Participant Flow|Placebo|Participants received placebo matched to DX-2930 subcutaneously (SC) once in every 2 weeks (q2wks) for 26 weeks.
11254780|NCT02586805|FG001|Participant Flow|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 milligram (mg) dose of DX-2930 SC once in every 4 weeks (q4wks) and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254781|NCT02586805|FG002|Participant Flow|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254782|NCT02586805|FG003|Participant Flow|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
11254783|NCT02586805|OG000|Outcome|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
11254784|NCT02586805|OG001|Outcome|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254785|NCT02586805|OG002|Outcome|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254786|NCT02586805|OG003|Outcome|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
11254787|NCT02586805|EG000|Reported Event|Placebo|Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
11254788|NCT02586805|EG001|Reported Event|Lanadelumab (DX-2930) 150 mg Every 4 Weeks|Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254789|NCT02586805|EG002|Reported Event|Lanadelumab (DX-2930) 300 mg Every 4 Weeks|Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
11254790|NCT02586805|EG003|Reported Event|Lanadelumab (DX-2930) 300 mg Every 2 Weeks|Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
11254791|NCT02586896|BG000|Baseline|Strengths-based Case Management (SBCM)|Participants received up to six sessions of Strengths-based Case Management (SBCM) within 90 days of randomization.
11254792|NCT02586896|BG001|Baseline|Screening, Assessment and Referral (SAR)|Participants received a detailed referral sheet, an informational pamphlet, and scripted feedback recommending they seek treatment.
11254793|NCT02586896|BG002|Baseline|Total|Total of all reporting groups
11254794|NCT02586896|FG000|Participant Flow|Strengths-based Case Management (SBCM)|"The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance.~The six case management sessions for this trial were based on those described in manuals developed by Dr. Rapp for two previous clinical trials. Each session was guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence. Initiation of the relationship between client and case manager began immediately following random assignment and termination took place when either (1) six sessions had occurred; (2) ninety days had elapsed; or (3) clients discontinued involvement."
11254795|NCT02586896|FG001|Participant Flow|Screening, Assessment and Referral (SAR)|"Participants in the SAR condition were provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. The research assistant provided SAR participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet included names, addresses, and phone numbers of local addiction treatment agencies. Participants also received an informational pamphlet about drug use and its consequences, addiction, and treatment.~Because the emergency department does not currently screen or refer systematically, the SAR condition represented a level of care significantly higher than treatment as usual."
11254796|NCT02586896|OG000|Outcome|Strengths-based Case Management (SBCM)|Strengths-based Case Management (SBCM)
11254797|NCT02586896|OG001|Outcome|Screening, Assessment and Referral (SAR)|Screening, Assessment and Referral (SAR)
11254798|NCT02586896|EG000|Reported Event|Strengths-based Case Management (SBCM)|Strengths-based Case Management (SBCM)
11254799|NCT02586896|EG001|Reported Event|Screening, Assessment and Referral (SAR)|Screening, Assessment and Referral (SAR)
11254800|NCT02586909|BG000|Baseline|RVT-101 35 mg Tablets|"once daily, oral tablets~RVT-101 35 mg tablets: once daily, oral tablets"
11254801|NCT02586909|FG000|Participant Flow|RVT-101 35 mg Tablets|"once daily, oral tablets~RVT-101 35 mg tablets: once daily, oral tablets"
11254802|NCT02586909|OG000|Outcome|RVT-101 35 mg Tablets|"once daily, oral tablets~RVT-101 35 mg tablets: once daily, oral tablets"
11254803|NCT02586909|EG000|Reported Event|RVT-101 35 mg Tablets|"once daily, oral tablets~RVT-101 35 mg tablets: once daily, oral tablets"
11254804|NCT02586974|BG000|Baseline|Group H+WB|"32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)~Humigard: warmed and humidified CO2 insufflation"
11254805|NCT02586974|BG001|Baseline|Group WB|32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
11254806|NCT02586974|BG002|Baseline|Total|Total of all reporting groups
11254807|NCT02586974|FG000|Participant Flow|Group H+WB|"32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)~Humigard: warmed and humidified CO2 insufflation"
11254808|NCT02586974|FG001|Participant Flow|Group WB|32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
11254809|NCT02586974|OG000|Outcome|Group Humigard+Warming Blanket (H+WB)|"32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)~Humigard: warmed and humidified CO2 insufflation"
11254810|NCT02586974|OG001|Outcome|Group Warming Blanket (WB)|32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
11254811|NCT02586974|OG000|Outcome|Group H+WB|"32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)~Humigard: warmed and humidified CO2 insufflation"
11254812|NCT02586974|OG001|Outcome|Group WB|32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
11254813|NCT02586974|EG000|Reported Event|Group H+WB|"32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)~Humigard: warmed and humidified CO2 insufflation"
11254814|NCT02586974|EG001|Reported Event|Group WB|32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
11254815|NCT02587065|BG000|Baseline|Peg-interferon Beta-1a 125 μg|Participants received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
11254816|NCT02587065|FG000|Participant Flow|Peg-interferon Beta-1a 125 μg|Participants received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
11254817|NCT02587065|OG000|Outcome|Peg-interferon Beta-1a 125 μg|Participants received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
11254818|NCT02587065|EG000|Reported Event|Peg-interferon Beta-1a 125 μg|Participants received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months.
11254819|NCT02587117|BG000|Baseline|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
11254820|NCT02587117|BG001|Baseline|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
11254821|NCT02587117|BG002|Baseline|Total|Total of all reporting groups
11254822|NCT02587117|FG000|Participant Flow|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
11254823|NCT02587117|FG001|Participant Flow|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
11254824|NCT02587117|OG000|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
11254825|NCT02587117|OG001|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
11254826|NCT02587117|EG000|Reported Event|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
11254827|NCT02587117|EG001|Reported Event|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
11254828|NCT02587143|BG000|Baseline|Control|"Alcohol -based spray as placebo will be administrated before arterial puncture.~Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture."
11254829|NCT02587143|BG001|Baseline|Ethyl Chloride|"Ethyl choride will be administrated before arterial puncture.~Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture."
11254830|NCT02587143|BG002|Baseline|Total|Total of all reporting groups
11254831|NCT02587143|FG000|Participant Flow|Ethyl Chloride|"Ethyl choride will be administrated before arterial puncture.~Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture."
11254832|NCT02587143|FG001|Participant Flow|Control|"Alcohol -based spray as placebo will be administrated before arterial puncture.~Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture."
11254833|NCT02587143|OG000|Outcome|Control|"Alcohol -based spray as placebo will be administrated before arterial puncture.~Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture."
11254834|NCT02587143|OG001|Outcome|Ethyl Chloride|"Ethyl choride will be administrated before arterial puncture.~Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture."
11254835|NCT02587143|EG000|Reported Event|Control|"Alcohol -based spray as placebo will be administrated before arterial puncture.~Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria)."
11254836|NCT02587143|EG001|Reported Event|Ethyl Chloride|"Ethyl choride will be administrated before arterial puncture.~Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria)."
11254837|NCT02587221|BG000|Baseline|aQIV|Subjects received one dose of aQIV vaccine
11254838|NCT02587221|BG001|Baseline|Non-influenza Comparator Vaccine|Subjects received one dose of non-influenza comparator vaccine (Boostrix)
11254839|NCT02587221|BG002|Baseline|Total|Total of all reporting groups
11254840|NCT02587221|FG000|Participant Flow|aQIV|A single dose of approximately 0.5 mL of aQIV was administered on Day 1.
11254841|NCT02587221|FG001|Participant Flow|Non-influenza Comparator Vaccine|A single dose of approximately 0.5 mL dose of Boostrix was administered on Day 1. (Boostrix = Non-influenza comparator vaccine)
11254842|NCT02587221|OG000|Outcome|aQIV|Subjects received one dose of aQIV vaccine
11254843|NCT02587221|OG001|Outcome|Non-influenza Comparator Vaccine|Subjects received one dose of non-influenza comparator vaccine (Boostrix)
11254844|NCT02587221|EG000|Reported Event|aQIV|A single dose of approximately 0.5 mL of aQIV was administered on Day 1 (NH 2016/17, SH 2017).
11254845|NCT02587221|EG001|Reported Event|Non-influenza Comparator Vaccine|Non-influenza Comparator Vaccine / A single dose of approximately 0.5 mL dose of Boostrix was administered on Day 1 (NH 2016/17, SH 2017). (Boostrix = Non-influenza comparator vaccine)
11254846|NCT02587234|BG000|Baseline|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254847|NCT02587234|BG001|Baseline|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254848|NCT02587234|BG002|Baseline|Total|Total of all reporting groups
11254849|NCT02587234|FG000|Participant Flow|Active|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254850|NCT02587234|FG001|Participant Flow|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254851|NCT02587234|OG000|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254852|NCT02587234|OG001|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254853|NCT02587234|EG000|Reported Event|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254854|NCT02587234|EG001|Reported Event|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training~peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
11254855|NCT02587351|BG000|Baseline|Metoprolol Succinate|"Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).~Metoprolol succinate: Extended release Metoprolol succinate"
11254856|NCT02587351|BG001|Baseline|Placebo|"Matched placebo~Placebo: Matching placebo"
11254857|NCT02587351|BG002|Baseline|Total|Total of all reporting groups
11254858|NCT02587351|FG000|Participant Flow|Metoprolol Succinate|"Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).~Metoprolol succinate: Extended release Metoprolol succinate"
11254859|NCT02587351|FG001|Participant Flow|Placebo|"Matched placebo~Placebo: Matching placebo"
11254860|NCT02587351|OG000|Outcome|Metoprolol Succinate|"Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).~Metoprolol succinate: Extended release Metoprolol succinate"
11254861|NCT02587351|OG001|Outcome|Placebo|"Matched placebo~Placebo: Matching placebo"
11254862|NCT02587351|EG000|Reported Event|Metoprolol Succinate|"Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily).~Metoprolol succinate: Extended release Metoprolol succinate"
11254863|NCT02587351|EG001|Reported Event|Placebo|"Matched placebo~Placebo: Matching placebo"
11254864|NCT02587819|BG000|Baseline|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
11254865|NCT02587819|FG000|Participant Flow|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
11254866|NCT02587819|OG000|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
11254867|NCT02587819|OG000|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
11254868|NCT02587819|EG000|Reported Event|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
11254869|NCT02587962|BG000|Baseline|Phase 1 - 5.6 mg|Dose escalation (Phase 1): 5.6 mg birinapant + pembrolizumab
11254870|NCT02587962|BG001|Baseline|Phase 1 - 11 mg|Dose escalation (Phase 1): 11 mg birinapant + pembrolizumab
11254871|NCT02587962|BG002|Baseline|Phase 1 - 17 mg|Dose escalation (Phase 1): 17 mg birinapant + pembrolizumab
11254872|NCT02587962|BG003|Baseline|Phase 1 - 22 mg|Dose escalation (Phase 1): 22 mg birinapant + pembrolizumab
11254873|NCT02587962|BG004|Baseline|Phase 2 - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab
11254874|NCT02587962|BG005|Baseline|Total|Total of all reporting groups
11254875|NCT02587962|FG000|Participant Flow|Phase 1 - 5.6 mg|Dose escalation (Phase 1): 5.6 mg birinapant + pembrolizumab
11254876|NCT02587962|FG001|Participant Flow|Phase 1 - 11 mg|Dose escalation (Phase 1): 11 mg birinapant + pembrolizumab
11254877|NCT02587962|FG002|Participant Flow|Phase 1 - 17 mg|Dose escalation (Phase 1): 17 mg birinapant + pembrolizumab
11254878|NCT02587962|FG003|Participant Flow|Phase 1 - 22 mg|Dose escalation (Phase 1): 22 mg birinapant + pembrolizumab
11254879|NCT02587962|FG004|Participant Flow|Phase 2 - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab
11254880|NCT02587962|OG000|Outcome|Phase 1 - 5.6 mg|Dose escalation (Phase 1): 5.6 mg birinapant + pembrolizumab
11254881|NCT02587962|OG001|Outcome|Phase 1 - 11 mg|Dose escalation (Phase 1): 11 mg birinapant + pembrolizumab
11254882|NCT02587962|OG002|Outcome|Phase 1 - 17 mg|Dose escalation (Phase 1): 17 mg birinapant + pembrolizumab
11254883|NCT02587962|OG003|Outcome|Phase 1 - 22 mg|Dose escalation (Phase 1): 22 mg birinapant + pembrolizumab
11254884|NCT02587962|OG004|Outcome|Phase 2 CRC - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab in colorectal cancer cohort.
11254885|NCT02587962|OG004|Outcome|Phase 2 CRC - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab
11254886|NCT02587962|OG000|Outcome|Phase 2 CRC - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab in colorectal cancer cohort (CRC)
11254887|NCT02587962|OG000|Outcome|Phase 2 - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab
11254888|NCT02587962|EG000|Reported Event|Phase 1 - 5.6 mg|Dose escalation (Phase 1): 5.6 mg birinapant + pembrolizumab
11254889|NCT02587962|EG001|Reported Event|Phase 1 - 11 mg|Dose escalation (Phase 1): 11 mg birinapant + pembrolizumab
11254890|NCT02587962|EG002|Reported Event|Phase 1 - 17 mg|Dose escalation (Phase 1): 17 mg birinapant + pembrolizumab
11254891|NCT02587962|EG003|Reported Event|Phase 1 - 22 mg|Dose escalation (Phase 1): 22 mg birinapant + pembrolizumab
11254892|NCT02587962|EG004|Reported Event|Phase 2 CRC - 22 mg|Dose expansion (Phase 2): 22 mg birinapant + pembrolizumab in colorectal cancer cohort
11254893|NCT02588092|BG000|Baseline|Cohort 1: 3 μg/kg Q3W|Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254894|NCT02588092|BG001|Baseline|Cohort 2: 6 μg/kg Q3W|Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254895|NCT02588092|BG002|Baseline|Cohort 3: 12 μg/kg Q3W|Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254896|NCT02588092|BG003|Baseline|Cohort 4: 22 μg/kg Q3W|Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254897|NCT02588092|BG004|Baseline|Cohort 5: 32 μg/kg Q3W|Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254898|NCT02588092|BG005|Baseline|Cohort 6: 52 μg/kg Q3W|Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254899|NCT02588092|BG006|Baseline|Cohort 7: 72 μg/kg Q3W|Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254900|NCT02588092|BG007|Baseline|Cohort 8: 92 μg/kg Q3W|Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254901|NCT02588092|BG008|Baseline|Cohort 9: 30 μg/kg QW|Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254902|NCT02588092|BG009|Baseline|Cohort 10: 37.5 μg/kg QW|Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254903|NCT02588092|BG010|Baseline|Total|Total of all reporting groups
11254904|NCT02588092|FG000|Participant Flow|Cohort 1: 3 μg/kg Q3W|Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254905|NCT02588092|FG001|Participant Flow|Cohort 2: 6 μg/kg Q3W|Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254906|NCT02588092|FG002|Participant Flow|Cohort 3: 12 μg/kg Q3W|Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254907|NCT02588092|FG003|Participant Flow|Cohort 4: 22 μg/kg Q3W|Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254908|NCT02588092|FG004|Participant Flow|Cohort 5: 32 μg/kg Q3W|Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle.
11254909|NCT02588092|FG005|Participant Flow|Cohort 6: 52 μg/kg Q3W|Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254910|NCT02588092|FG006|Participant Flow|Cohort 7: 72 μg/kg Q3W|Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254911|NCT02588092|FG007|Participant Flow|Cohort 8: 92 μg/kg Q3W|Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254912|NCT02588092|FG008|Participant Flow|Cohort 9: 30 μg/kg QW|Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254913|NCT02588092|FG009|Participant Flow|Cohort 10: 37.5 μg/kg QW|Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254914|NCT02588092|OG000|Outcome|Cohort 1: 3 μg/kg Q3W|Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254915|NCT02588092|OG001|Outcome|Cohort 2: 6 μg/kg Q3W|Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254916|NCT02588092|OG002|Outcome|Cohort 3: 12 μg/kg Q3W|Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254917|NCT02588092|OG003|Outcome|Cohort 4: 22 μg/kg Q3W|Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254918|NCT02588092|OG004|Outcome|Cohort 5: 32 μg/kg Q3W|Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254919|NCT02588092|OG005|Outcome|Cohort 6: 52 μg/kg Q3W|Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254920|NCT02588092|OG006|Outcome|Cohort 7: 72 μg/kg Q3W|Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254921|NCT02588092|OG007|Outcome|Cohort 8: 92 μg/kg Q3W|Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254922|NCT02588092|OG008|Outcome|Cohort 9: 30 μg/kg QW|Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254923|NCT02588092|OG009|Outcome|Cohort 10: 37.5 μg/kg QW|Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254924|NCT02588092|OG000|Outcome|Part 1: ADCT-301 Dose Escalation|"Weekly administration: Participants received an IV infusion of ADCT-301, on Days 1, 8, and 15 of each 3-week (21-day) cycle.~3-week administration: Participants received an IV infusion of ADCT-301, on Day 1 of each 3-week (21-day) cycle.~The dose escalation was conducted according to a 3+3 design."
11254925|NCT02588092|OG000|Outcome|Cohort 9: 30 μg/kg QW|Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254926|NCT02588092|OG001|Outcome|Cohort 10: 37.5 μg/kg QW|Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254927|NCT02588092|OG000|Outcome|Part 1: ADCT-301 Dose Escalation|"Weekly administration: Participants received an IV infusion of ADCT-301, on Days 1, 8, and 15 of each 3-week (21-day) cycle.~3-week administration: Participants received an IV infusion of ADCT-301, on Day 1 of each 3-week (21-day) cycle."
11254928|NCT02588092|EG000|Reported Event|Cohort 1: 3 μg/kg Q3W|Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254929|NCT02588092|EG001|Reported Event|Cohort 2: 6 μg/kg Q3W|Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254930|NCT02588092|EG002|Reported Event|Cohort 3: 12 μg/kg Q3W|Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254931|NCT02588092|EG003|Reported Event|Cohort 4: 22 μg/kg Q3W|Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254932|NCT02588092|EG004|Reported Event|Cohort 5: 32 μg/kg Q3W|Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254933|NCT02588092|EG005|Reported Event|Cohort 6: 52 μg/kg Q3W|Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254934|NCT02588092|EG006|Reported Event|Cohort 7: 72 μg/kg Q3W|Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254935|NCT02588092|EG007|Reported Event|Cohort 8: 92 μg/kg Q3W|Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
11254936|NCT02588092|EG008|Reported Event|Cohort 9: 30 μg/kg QW|Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11254937|NCT02588092|EG009|Reported Event|Cohort 10: 37.5 μg/kg QW|Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle.
11286496|NCT02889289|BG000|Baseline|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities."
11286497|NCT02889289|FG000|Participant Flow|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities."
11286498|NCT02889289|OG000|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities."
11286499|NCT02889289|EG000|Reported Event|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities."
11286500|NCT02889393|BG000|Baseline|Standard of Care Followed by Teduglutide|"Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks.~Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.~Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously.~Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion."
11286501|NCT02889393|BG001|Baseline|Teduglutide Followed by Standard of Care|"Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks.~Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure~Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously.~Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion."
11286502|NCT02889393|BG002|Baseline|Total|Total of all reporting groups
11286503|NCT02889393|FG000|Participant Flow|Standard of Care Followed by Teduglutide|"Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks.~Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.~Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously.~Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion."
11286504|NCT02889393|FG001|Participant Flow|Teduglutide Followed by Standard of Care|"Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks.~Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure~Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously.~Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion."
11286505|NCT02889393|OG000|Outcome|Teduglutide Intervention|Participants that received Teduglutide for 8 weeks
11286506|NCT02889393|OG001|Outcome|Standard of Care Intervention|Participants that received Standard of Care for 8 weeks
11254938|NCT04960228|BG000|Baseline|Altruism Video Intervention|"Participants will watch a 3-minute video about COVID-19 vaccination that elicits altruistic motives. The role of this arm is to test whether altruistic themes are an effective way to promote COVID-19 vaccination amongst young people and whether a video format is preferable for this group.~Altruism Video: The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others."
11254939|NCT04960228|BG001|Baseline|Informational Text Intervention|"Participants will read a brief informational text including information drawn from the Public Health Agency of Canada website (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#self). The purpose of this arm is to provide an active comparator with information about COVID-19 preventative health behaviors that has been strongly recommended to the public since the beginning of the pandemic. By doing this, we will assess if the video intervention changes vaccination intentions more than a presentation of general, well-known COVID-19 related information.~COVID-19 Informational Text: The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions."
11254940|NCT04960228|BG002|Baseline|Total|Total of all reporting groups
11254941|NCT04960228|FG000|Participant Flow|Altruism Video Intervention|"Participants will watch a 3-minute video about COVID-19 vaccination that elicits altruistic motives. The role of this arm is to test whether altruistic themes are an effective way to promote COVID-19 vaccination amongst young people and whether a video format is preferable for this group.~Altruism Video: The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others."
11254942|NCT04960228|FG001|Participant Flow|Informational Text Intervention|"Participants will read a brief informational text including information drawn from the Public Health Agency of Canada website (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#self). The purpose of this arm is to provide an active comparator with information about COVID-19 preventative health behaviors that has been strongly recommended to the public since the beginning of the pandemic. By doing this, we will assess if the video intervention changes vaccination intentions more than a presentation of general, well-known COVID-19 related information.~COVID-19 Informational Text: The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions."
11254943|NCT04960228|OG000|Outcome|Altruism Video Intervention|"Participants will watch a 3-minute video about COVID-19 vaccination that elicits altruistic motives. The role of this arm is to test whether altruistic themes are an effective way to promote COVID-19 vaccination amongst young people and whether a video format is preferable for this group.~Altruism Video: The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others."
11254944|NCT04960228|OG001|Outcome|Informational Text Intervention|"Participants will read a brief informational text including information drawn from the Public Health Agency of Canada website (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#self). The purpose of this arm is to provide an active comparator with information about COVID-19 preventative health behaviors that has been strongly recommended to the public since the beginning of the pandemic. By doing this, we will assess if the video intervention changes vaccination intentions more than a presentation of general, well-known COVID-19 related information.~COVID-19 Informational Text: The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions."
11254945|NCT04960228|EG000|Reported Event|Altruism Video Intervention|"Participants will watch a 3-minute video about COVID-19 vaccination that elicits altruistic motives. The role of this arm is to test whether altruistic themes are an effective way to promote COVID-19 vaccination amongst young people and whether a video format is preferable for this group.~Altruism Video: The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others."
11254946|NCT04960228|EG001|Reported Event|Informational Text Intervention|"Participants will read a brief informational text including information drawn from the Public Health Agency of Canada website (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#self). The purpose of this arm is to provide an active comparator with information about COVID-19 preventative health behaviors that has been strongly recommended to the public since the beginning of the pandemic. By doing this, we will assess if the video intervention changes vaccination intentions more than a presentation of general, well-known COVID-19 related information.~COVID-19 Informational Text: The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions."
11286507|NCT02889393|OG000|Outcome|All Participants|Participants that received both standard of care and teduglutide interventions after a combined 16 weeks
11286508|NCT02889393|EG000|Reported Event|On Teduglutide|"The study is a crossover design. All participants received 8 weeks of daily Teduglutide.~Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously."
11254947|NCT03922477|BG000|Baseline|Atezolizumab + Hu5F9-G4|An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
11254948|NCT03922477|FG000|Participant Flow|Atezolizumab + Hu5F9-G4|An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
11254949|NCT03922477|OG000|Outcome|Atezolizumab + Hu5F9-G4|An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle.
11254950|NCT03922477|EG000|Reported Event|Safety_Cohort|An initial safety evaluation was to be performed in participants with relapsed AML. A total of 19 participants were screened for enrollment; 8 failed screening. 13 were enrolled but only 11 received study treatment. All 11 patients enrolled in the safety cohort discontinued the study.
11286509|NCT02889393|EG001|Reported Event|On Standard of Care|"The study is a crossover design. All participants received 8 weeks of daily Standard of Care Therapy.~Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion."
11286510|NCT02889510|BG000|Baseline|All Participants|All participants in the study.
11286511|NCT02889510|FG000|Participant Flow|Liraglutide First, Then Placebo|treatment with subcutaneus liraglutide for 7 weeks once daily followed by treatment with subcutaneus placebo for 7 weeks
11286512|NCT02889510|FG001|Participant Flow|Placebo First, Then Liraglutide|treatment with subcutaneus placebo for 7 weeks once daily followed by treatment with subcutaneus liraglutide for 7 weeks
11286513|NCT02889510|OG000|Outcome|Liraglutide|"7-week subcutaneous liraglutide treatment once daily~liraglutide: 7-week subcutaneous liraglutide once daily"
11286514|NCT02889510|OG001|Outcome|Placebo|"7-week subcutaneous placebo treatment once daily.~placebo: 7-week subcutaneous placebo once daily"
11286515|NCT02889510|EG000|Reported Event|Liraglutide|"7-week subcutaneous liraglutide treatment once daily~liraglutide: 7-week subcutaneous liraglutide once daily"
11286516|NCT02889510|EG001|Reported Event|Placebo|"7-week subcutaneous placebo treatment once daily.~placebo: 7-week subcutaneous placebo once daily"
11286517|NCT02889562|BG000|Baseline|Apixaban|"Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in dose modifications. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin."
11286518|NCT02889562|BG001|Baseline|Warfarin|"While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin.~After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications."
11286519|NCT02889562|BG002|Baseline|Total|Total of all reporting groups
11286520|NCT02889562|FG000|Participant Flow|Apixaban|"Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in dose modifications. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin."
11254951|NCT03688074|BG000|Baseline|Teze 210 mg Q4W|Tezepelumab subcutaneous injection
11254952|NCT03688074|BG001|Baseline|Placebo|Placebo subcutaneous injection
11254953|NCT03688074|BG002|Baseline|Total|Total of all reporting groups
11254954|NCT03688074|FG000|Participant Flow|Teze 210 mg Q4W|Tezepelumab subcutaneous injection
11254955|NCT03688074|FG001|Participant Flow|Placebo|Placebo subcutaneous injection
11254956|NCT03688074|OG000|Outcome|Teze 210 mg Q4W|Tezepelumab subcutaneous injection
11254957|NCT03688074|OG001|Outcome|Placebo|Placebo subcutaneous injection
11254958|NCT03688074|EG000|Reported Event|Placebo|Placebo subcutaneous injection
11254959|NCT03688074|EG001|Reported Event|Teze 210 mg Q4W|Tezepelumab subcutaneous injection
11254960|NCT03342001|BG000|Baseline|Calcitonin|People with hypothyroidism
11254961|NCT03342001|FG000|Participant Flow|Treatment Group, Open Label|"calcitonin nasal spray, 200 mcg daily~Calcitonin: calcitonin nasal spray"
11254962|NCT03342001|OG000|Outcome|Treatment Group, Open Label|"calcitonin nasal spray, 200 mcg daily~Calcitonin: calcitonin nasal spray"
11254963|NCT03342001|EG000|Reported Event|Treatment Group, Open Label|"calcitonin nasal spray, 200 mcg daily~Calcitonin: calcitonin nasal spray"
11254964|NCT02871934|BG000|Baseline|PGx+|"Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254965|NCT02871934|BG001|Baseline|PGx-|"Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254966|NCT02871934|BG002|Baseline|Total|Total of all reporting groups
11254967|NCT02871934|FG000|Participant Flow|PGx+|"Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254968|NCT02871934|FG001|Participant Flow|PGx-|"Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254969|NCT02871934|OG000|Outcome|PGx+|"Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254970|NCT02871934|OG001|Outcome|PGx-|"Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254971|NCT02871934|EG000|Reported Event|PGx+|"Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254972|NCT02871934|EG001|Reported Event|PGx-|"Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).~SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C."
11254973|NCT02859558|BG000|Baseline|Arm 1: Fiebig I/II|"Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254974|NCT02859558|BG001|Baseline|Arm 2: Fiebig III/IV|"Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254975|NCT02859558|BG002|Baseline|Arm 3: Fiebig V|"Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254976|NCT02859558|BG003|Baseline|Fiebig VI|"Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254977|NCT02859558|BG004|Baseline|HIV-negative|Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
11254978|NCT02859558|BG005|Baseline|Total|Total of all reporting groups
11254979|NCT02859558|FG000|Participant Flow|Arm 1: Fiebig I/II|"Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254980|NCT02859558|FG001|Participant Flow|Arm 2: Fiebig III/IV|"Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254981|NCT02859558|FG002|Participant Flow|Arm 3: Fiebig V|"Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254982|NCT02859558|FG003|Participant Flow|Fiebig VI|"Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254983|NCT02859558|FG004|Participant Flow|HIV-negative|Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
11254984|NCT02859558|OG000|Outcome|Arm 1: Fiebig I/II|"Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254985|NCT02859558|OG001|Outcome|Arm 2: Fiebig III/IV|"Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254986|NCT02859558|OG002|Outcome|Arm 3: Fiebig V|"Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254987|NCT02859558|EG000|Reported Event|Arm 1: Fiebig I/II|"Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254988|NCT02859558|EG001|Reported Event|Arm 2: Fiebig III/IV|"Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254989|NCT02859558|EG002|Reported Event|Arm 3: Fiebig V|"Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254990|NCT02859558|EG003|Reported Event|Fiebig VI|"Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).~elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen."
11254991|NCT02859558|EG004|Reported Event|HIV-negative|Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
11254992|NCT02818920|BG000|Baseline|Pembrolizumab Prior to and After Surgery|"Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 & 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles~-Note: Standard radiation therapy in selected patients for standard clinical indications"
11254993|NCT02818920|FG000|Participant Flow|Pembrolizumab Prior to and After Surgery|"Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 & 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles~-Note: Standard radiation therapy in selected patients for standard clinical indications"
11254994|NCT02818920|OG000|Outcome|Pembrolizumab Prior to and After Surgery|"Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 & 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles~-Note: Standard radiation therapy in selected patients for standard clinical indications"
11254995|NCT02818920|EG000|Reported Event|Pembrolizumab Prior to and After Surgery|"Pembrolizumab: Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 & 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles~-Note: Standard radiation therapy in selected patients for standard clinical indications"
11254996|NCT02481310|BG000|Baseline|Treatment- Cohort 1(Combination Chemotherapy, Rituximab, Ixazomib 2.3 mg)|"INDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11335461|NCT03550989|FG000|Participant Flow|Non-Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.~Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).~Non-Exposure Event: Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.~Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS)."
11254997|NCT02481310|BG001|Baseline|Treatment Cohort 2 and Phase II (Combination Chemotherapy, Rituximab, Ixazomib 3 mg)|"NDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11254998|NCT02481310|BG002|Baseline|Treatment - Cohort 3 (Combination Chemotherapy, Rituximab, Ixazomib 4 mg)|"NDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11254999|NCT02481310|BG003|Baseline|Total|Total of all reporting groups
11255000|NCT02481310|FG000|Participant Flow|Treatment- Cohort 1(Combination Chemotherapy, Rituximab, Ixazomib 2.3 mg)|"INDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11255001|NCT02481310|FG001|Participant Flow|Treatment Cohort 2 and Phase II (Combination Chemotherapy, Rituximab, Ixazomib 3 mg)|"NDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11255002|NCT02481310|FG002|Participant Flow|Treatment - Cohort 3 (Combination Chemotherapy, Rituximab, Ixazomib 4 mg)|"NDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11255003|NCT02481310|OG000|Outcome|Treatment (Combination Chemotherapy, Rituximab, Ixazomib)|"INDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11255004|NCT02481310|EG000|Reported Event|Treatment (Combination Chemotherapy, Rituximab, Ixazomib)|"INDUCTION:~Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr on day 1; and cyclophosphamide IV over 90 minutes on day 5.~CNS PROPHYLAXIS:~Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly.~MAINTENANCE:~Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.~Cyclophosphamide: Given IV~Cytarabine: Given IT or intraventricularly~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ixazomib Citrate: Given PO~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IT or intraventricularly~Prednisone: Given PO~Rituximab: Given IV~Therapeutic Hydrocortisone: Given IT or intraventricularly~Vincristine Sulfate: Given IV"
11286521|NCT02889562|FG001|Participant Flow|Warfarin|"While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin.~After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications."
11286522|NCT02889562|OG000|Outcome|Apixaban|"Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in dose modifications. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin."
11286523|NCT02889562|OG001|Outcome|Warfarin|"While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin.~After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications."
11286524|NCT02889562|EG000|Reported Event|Apixaban|"Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in dose modifications. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin."
11337361|NCT03582943|OG000|Outcome|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11255005|NCT02343952|BG000|Baseline|Experimental Arm|"Pembrolizumab -200 mg IV 3 weeks~Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab."
11255006|NCT02343952|FG000|Participant Flow|Experimental Arm|"Pembrolizumab -200 mg IV 3 weeks~Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab."
11255007|NCT02343952|OG000|Outcome|Experimental Arm|"Pembrolizumab -200 mg IV 3 weeks~Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab."
11255008|NCT02343952|EG000|Reported Event|Experimental Arm|"Pembrolizumab -200 mg IV 3 weeks~Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab."
11255009|NCT02326155|BG000|Baseline|Remsima (CT-P13)|Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255010|NCT02326155|BG001|Baseline|Switched to Remsima (CT-P13)|Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255011|NCT02326155|BG002|Baseline|Total|Total of all reporting groups
11255012|NCT02326155|FG000|Participant Flow|Remsima (CT-P13)|Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255013|NCT02326155|FG001|Participant Flow|Switched to Remsima (CT-P13)|Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255014|NCT02326155|OG000|Outcome|Remsima (CT-P13)|Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255015|NCT02326155|OG001|Outcome|Switched to Remsima (CT-P13)|Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255016|NCT02326155|EG000|Reported Event|Remsima (CT-P13)|Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255017|NCT02326155|EG001|Reported Event|Switched to Remsima (CT-P13)|Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
11255018|NCT02304367|BG000|Baseline|Burosumab|Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.
11255019|NCT02304367|FG000|Participant Flow|Burosumab|Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.
11255020|NCT02304367|OG000|Outcome|Burosumab|Participants received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.
11255021|NCT02304367|OG000|Outcome|Elbow Flexion|Elbow flexor (biceps brachii, brachioradialis, and brachialis) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.
11255022|NCT02304367|OG001|Outcome|Elbow Extension|Elbow extensor (triceps brachii and anconeus) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.
11255023|NCT02304367|OG000|Outcome|Knee Flexion|Knee flexor (hamstring) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.
11255024|NCT02304367|OG001|Outcome|Knee Extension|Knee extensor (quadriceps) muscle strength was measured in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W. Doses may have been titrated up to a maximum of 2.0 mg/kg Q2W.
11255025|NCT02304367|OG000|Outcome|Left Upper Extremity|Left arm lifts in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W, titrated up to a maximum of 2.0 mg/kg Q2W.
11255026|NCT02304367|OG001|Outcome|Right Upper Extremity|Right arm lifts in participants who received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously Q4W, titrated up to a maximum of 2.0 mg/kg Q2W.
11255027|NCT02304367|EG000|Reported Event|KRN23 TIO|Participants with TIO received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.
11255028|NCT02304367|EG001|Reported Event|KRN23 XLH and ENS|Participants with XLH and ENS received burosumab at a starting dose of 0.3 mg/kg administered subcutaneously (SC) every 4 weeks (Q4W). Doses may have been titrated up to a maximum of 2.0 mg/kg every 2 weeks (Q2W) in order to achieve fasting peak serum phosphorus levels within the target range of 2.5 to 4.0 mg/dL.
11255029|NCT01810705|BG000|Baseline|GRASPA|In the experimental group, the patients will receive one administration of GRASPA (100 IU/kg) at Day 11 in combination with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months
11255030|NCT01810705|BG001|Baseline|Control|In the control arm, patients will be treated with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months. Each period of 28 days constitute a cycle of chemotherapy.
11255031|NCT01810705|BG002|Baseline|Total|Total of all reporting groups
11255032|NCT01810705|FG000|Participant Flow|GRASPA|"patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm Control)~GRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum"
11255033|NCT01810705|FG001|Participant Flow|Control|patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months
11255034|NCT01810705|OG000|Outcome|GRASPA|"patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm Control)~GRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum"
11255035|NCT01810705|OG001|Outcome|Control|patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months
11255036|NCT01810705|EG000|Reported Event|GRASPA|Patients having received at least one injection of GRASPA (100 IU/kg) i.e. 81 in GRASPA arm
11255037|NCT01810705|EG001|Reported Event|Control|Patients having received at least one dose of study treatment i.e. 39 in control arm
11255038|NCT02588261|BG000|Baseline|ASP8273|Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255039|NCT02588261|BG001|Baseline|Erlotinib or Gefitinib|Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255040|NCT02588261|BG002|Baseline|Total|Total of all reporting groups
11255041|NCT02588261|FG000|Participant Flow|ASP8273|Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255042|NCT02588261|FG001|Participant Flow|Erlotinib or Gefitinib|Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255043|NCT02588261|OG000|Outcome|ASP8273|Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255044|NCT02588261|OG001|Outcome|Erlotinib or Gefitinib|Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255045|NCT02588261|EG000|Reported Event|ASP8273|Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255046|NCT02588261|EG001|Reported Event|Erlotinib or Gefitinib|Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).
11255047|NCT02588339|BG000|Baseline|Panobinostat (PANO) Therapy|Participants will be treated with standard of care chemotherapy agents prior to their allogeneic hematopoietic cell transplant. For Graft Versus Host Disease (GVHD) prevention, participants will receive PANO, Sirolimus and Tacrolimus.
11255048|NCT02588339|FG000|Participant Flow|Panobinostat (PANO) Therapy|Participants treated with standard of care chemotherapy agents prior to their allogeneic hematopoietic cell transplant. For Graft Versus Host Disease (GVHD) prevention, participants received PANO, Sirolimus and Tacrolimus. GVHD graded using NIH criteria, scores of 0-3 per area of involvement (e.g; skin, liver and gut) 0 being no symptoms and 3 being symptomatic, over 50% of waking hours in bed, ECOG 3-4.
11255049|NCT02588339|OG000|Outcome|Panobinostat (PANO) Therapy|Participants will be treated with standard of care chemotherapy agents prior to their allogeneic hematopoietic cell transplant. For Graft Versus Host Disease (GVHD) prevention, participants will receive PANO, Sirolimus and Tacrolimus.
11255050|NCT02588339|EG000|Reported Event|Panobinostat (PANO) Therapy|Participants will be treated with standard of care chemotherapy agents prior to their allogeneic hematopoietic cell transplant. For Graft Versus Host Disease (GVHD) prevention, participants will receive PANO, Sirolimus and Tacrolimus.
11255051|NCT02588573|BG000|Baseline|Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study.
11255052|NCT02588573|BG001|Baseline|Habitual FREQ Wearers Wearing Etafilcon A/Somofilcon A|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study.
11255053|NCT02588573|BG002|Baseline|Total|Total of all reporting groups
11255054|NCT02588573|FG000|Participant Flow|Habitual Etafilcon A Wearers|Habitual wearers of etafilcon A were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study
11255055|NCT02588573|FG001|Participant Flow|Habitual FREQ Wearers|Habitual wearers of other frequent replacement lenses (FREQ) were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study.
11255056|NCT02588573|OG000|Outcome|Habitual Etafilcon A Wearers Randomized to Etafilcon A|"Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.~etafilcon A (control): contact lens"
11255057|NCT02588573|OG001|Outcome|Habitual Etafilcon A Wearers Randomized to Somofilcon A|"Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.~somofilcon A (test): contact lens"
11255058|NCT02588573|OG002|Outcome|Habitual FREQ Wearers Randomized to Etafilcon A|"Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.~etafilcon A (control): contact lens"
11255059|NCT02588573|OG003|Outcome|Habitual FREQ Wearers Randomized to Somofilcon A|"Habitual wearers frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.~somofilcon A (test): contact lens"
11255060|NCT02588573|OG000|Outcome|Habitual Etafilcon A Wearers - Baseline|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255061|NCT02588573|OG001|Outcome|Habitual FREQ Wearers - Baseline|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255062|NCT02588573|OG002|Outcome|Habitual Etafilcon A Wearers - 8hrs|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255063|NCT02588573|OG003|Outcome|Habitual FREQ Wearers - 8hrs|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255064|NCT02588573|OG000|Outcome|Habitual Etafilcon A Wearers Randomized to Etafilcon A|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255065|NCT02588573|OG001|Outcome|Habitual Etafilcon A Wearers Randomized to Somofilcon A|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255066|NCT02588573|OG002|Outcome|Habitual FREQ Wearers Randomized to Etafilcon A|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255067|NCT02588573|OG003|Outcome|Habitual FREQ Wearers Randomized to Somofilcon A|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255068|NCT02588573|EG000|Reported Event|Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255069|NCT02588573|EG001|Reported Event|Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp|Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255070|NCT02588573|EG002|Reported Event|Etafilcon A Lens (Control) Worn by Habitual FREQ Grp|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255071|NCT02588573|EG003|Reported Event|Somofilcon A Lens (Test) Worn by Habitual FREQ Grp|Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design.
11255072|NCT02588586|BG000|Baseline|3BNC117 + ART Interruption|"Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.~3BNC117: 3BNC117 infusions~Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36."
11255073|NCT02588586|FG000|Participant Flow|3BNC117 + ART Interruption|"Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.~3BNC117: 3BNC117 infusions~Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36."
11255074|NCT02588586|OG000|Outcome|3BNC117 + ART Interruption|"Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.~3BNC117: 3BNC117 infusions~Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36."
11255075|NCT02588586|EG000|Reported Event|3BNC117 + ART Interruption|"Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.~3BNC117: 3BNC117 infusions~Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36."
11255076|NCT02588599|BG000|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11255077|NCT02588599|FG000|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11255078|NCT02588599|OG000|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11255079|NCT02588599|EG000|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
11255080|NCT02588612|BG000|Baseline|Lete-cel|Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel.
11255081|NCT02588612|FG000|Participant Flow|Lete-cel|Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel.
11255082|NCT02588612|OG000|Outcome|Lete-cel|Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel.
11255083|NCT02588612|EG000|Reported Event|Lete-cel|Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel.
11255084|NCT02588664|BG000|Baseline|Usual Care|Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
11255085|NCT02588664|BG001|Baseline|COMPASS Intervention|"Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.~COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.~Patient will receive a follow-up telephone call two days after having been discharged.~7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.~Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services."
11255086|NCT02588664|BG002|Baseline|Total|Total of all reporting groups
11255087|NCT02588664|FG000|Participant Flow|Usual Care|Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
11255088|NCT02588664|FG001|Participant Flow|COMPASS Intervention|"Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.~COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.~Patient will receive a follow-up telephone call two days after having been discharged.~7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.~Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services."
11255089|NCT02588664|OG000|Outcome|Usual Care|Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
11255090|NCT02588664|OG001|Outcome|COMPASS Intervention|"Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.~COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.~Patient will receive a follow-up telephone call two days after having been discharged.~7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.~Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services."
11255091|NCT02588664|EG000|Reported Event|Usual Care|Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
11255092|NCT02588664|EG001|Reported Event|COMPASS Intervention|"Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.~COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.~Patient will receive a follow-up telephone call two days after having been discharged.~7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.~Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services."
11255093|NCT02588833|BG000|Baseline|Cohort 1|Subjects received SC injections of pegcetacoplan 180 mg/day for up to 28 days.
11255094|NCT02588833|BG001|Baseline|Cohort 2|Subjects received SC injections or infusions of pegcetacoplan 270 mg/day for up to 364 days if entering the open-label extension study or, if entering Part 2C, until enrollment in the open-label extension study became available. If clinically indicated on the basis of response, the pegcetacoplan dosage could be increased up to 360 mg/day.
11255095|NCT02588833|BG002|Baseline|Total|Total of all reporting groups
11255096|NCT02588833|FG000|Participant Flow|Cohort 1|Subjects received subcutaneous (SC) injections of pegcetacoplan 180 milligrams (mg)/day for up to 28 days.
11255097|NCT02588833|FG001|Participant Flow|Cohort 2|Subjects received SC injections or infusions of pegcetacoplan 270 mg/day for up to 364 days if entering the open-label extension study or, if entering Part 2C, until enrollment in the open-label extension study became available. If clinically indicated on the basis of response, the pegcetacoplan dosage could be increased up to 360 mg/day.
11255098|NCT02588833|OG000|Outcome|Cohort 1|Subjects received SC injections of pegcetacoplan 180 mg/day for up to 28 days.
11255099|NCT02588833|OG001|Outcome|Cohort 2|Subjects received SC injections or infusions of pegcetacoplan 270 mg/day for up to 364 days if entering the open-label extension study or, if entering Part 2C, until enrollment in the open-label extension study became available. If clinically indicated on the basis of response, the pegcetacoplan dosage could be increased up to 360 mg/day.
11255100|NCT02588833|OG000|Outcome|Cohort 2|Subjects received SC injections or infusions of pegcetacoplan 270 mg/day for up to 364 days if entering the open-label extension study or, if entering Part 2C, until enrollment in the open-label extension study became available. If clinically indicated on the basis of response, the pegcetacoplan dosage could be increased up to 360 mg/day.
11255101|NCT02588833|EG000|Reported Event|Cohort 1|Subjects received SC injections of pegcetacoplan 180 mg/day for up to 28 days.
11255102|NCT02588833|EG001|Reported Event|Cohort 2|Subjects received SC injections or infusions of pegcetacoplan 270 mg/day for up to 364 days if entering the open-label extension study or, if entering Part 2C, until enrollment in the open-label extension study became available. If clinically indicated on the basis of response, the pegcetacoplan dosage could be increased up to 360 mg/day.
11255103|NCT02588872|BG000|Baseline|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
11255104|NCT02588872|BG001|Baseline|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
11255105|NCT02588872|BG002|Baseline|Total|Total of all reporting groups
11255106|NCT02588872|FG000|Participant Flow|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
11255107|NCT02588872|FG001|Participant Flow|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
11255108|NCT02588872|OG000|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
11255109|NCT02588872|OG001|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
11255110|NCT02588872|EG000|Reported Event|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
11255111|NCT02588872|EG001|Reported Event|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
11255112|NCT02588976|BG000|Baseline|All Patients|
11255113|NCT02588976|FG000|Participant Flow|ACT Measurements|"ACT measurements by SONOCLOT Analyzer during cardiac surgery~Sonoclot Analyzer: Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer"
11255114|NCT02588976|OG000|Outcome|All Patients|
11255115|NCT02588976|OG000|Outcome|ACT Measurements|"ACT measurements by SONOCLOT Analyzer during cardiac surgery~Sonoclot Analyzer: Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer"
11255116|NCT02588976|EG000|Reported Event|All Patients|
11255117|NCT02589067|BG000|Baseline|0.12% Chlorhexidine Gluconate Oral Rinse|"Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.~Chlorhexidine gluconate: Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255118|NCT02589067|BG001|Baseline|Saline Placebo Oral Rinse|"Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.~Saline Placebo: Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255119|NCT02589067|BG002|Baseline|Total|Total of all reporting groups
11255120|NCT02589067|FG000|Participant Flow|0.12% Chlorhexidine Gluconate Oral Rinse|"Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.~Chlorhexidine gluconate: Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255121|NCT02589067|FG001|Participant Flow|Saline Placebo Oral Rinse|"Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.~Saline Placebo: Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255122|NCT02589067|OG000|Outcome|0.12% Chlorhexidine Gluconate Oral Rinse|"Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.~Chlorhexidine gluconate: Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255123|NCT02589067|OG001|Outcome|Saline Placebo Oral Rinse|"Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.~Saline Placebo: Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255124|NCT02589067|OG001|Outcome|Saline Placebo Oral Rinse,|"Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.~Saline Placebo: Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255125|NCT02589067|EG000|Reported Event|0.12% Chlorhexidine Gluconate Oral Rinse|"Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.~Chlorhexidine gluconate: Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255126|NCT02589067|EG001|Reported Event|Saline Placebo Oral Rinse|"Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.~Saline Placebo: Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus."
11255127|NCT02589171|BG000|Baseline|Neo Close Abdominal Closure|Neo Close Abdominal Closure: Neo Close Abdominal Closure
11255128|NCT02589171|BG001|Baseline|Carter Thomason Device|Carter Thomason Device: Carter Thomason Device
11255129|NCT02589171|BG002|Baseline|Total|Total of all reporting groups
11255130|NCT02589171|FG000|Participant Flow|Neo Close Abdominal Closure|Neo Close Abdominal Closure: Neo Close Abdominal Closure
11255131|NCT02589171|FG001|Participant Flow|Carter Thomason Device|Carter Thomason Device: Carter Thomason Device
11255132|NCT02589171|OG000|Outcome|Neo Close Abdominal Closure|Neo Close Abdominal Closure: Neo Close Abdominal Closure
11255133|NCT02589171|OG001|Outcome|Carter Thomason Device|Carter Thomason Device: Carter Thomason Device
11255134|NCT02589171|EG000|Reported Event|Neo Close Abdominal Closure|Neo Close Abdominal Closure: Neo Close Abdominal Closure
11255135|NCT02589171|EG001|Reported Event|Carter Thomason Device|Carter Thomason Device: Carter Thomason Device
11255136|NCT02589405|BG000|Baseline|Three-part Treatment Regimen|Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
11255137|NCT02589405|FG000|Participant Flow|Three-part Treatment Regimen|Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
11255138|NCT02589405|OG000|Outcome|Treatment Regimen|Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
11255139|NCT02589405|EG000|Reported Event|Three-part Treatment Regimen|Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
11255140|NCT02589626|BG000|Baseline|Empagliflozin 10 mg|Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
11255141|NCT02589626|BG001|Baseline|Empagliflozin 25 mg|Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
11255142|NCT02589626|BG002|Baseline|Total|Total of all reporting groups
11255143|NCT02589626|FG000|Participant Flow|Empagliflozin 10 mg|Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
11255144|NCT02589626|FG001|Participant Flow|Empagliflozin 25 mg|Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
11255145|NCT02589626|OG000|Outcome|Empagliflozin 10 mg|Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
11255146|NCT02589626|OG001|Outcome|Empagliflozin 25 mg|Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
11255147|NCT02589626|EG000|Reported Event|Empagliflozin 10 mg|Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
11255148|NCT02589626|EG001|Reported Event|Empagliflozin 25mg|Patients were orally administered film-coated tablet of Empagliflozin 10 mg once in the morning for 52 weeks
11255149|NCT02589639|BG000|Baseline|Empagliflozin 10 mg|Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255150|NCT02589639|BG001|Baseline|Empagliflozin 25 mg|Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255151|NCT02589639|BG002|Baseline|Placebo|Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period
11255152|NCT02589639|BG003|Baseline|Total|Total of all reporting groups
11255153|NCT02589639|FG000|Participant Flow|Placebo|Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period
11255154|NCT02589639|FG001|Participant Flow|Empagliflozin 10 mg|Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255155|NCT02589639|FG002|Participant Flow|Empagliflozin 25 mg|Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255156|NCT02589639|OG000|Outcome|Placebo|Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period
11255157|NCT02589639|OG001|Outcome|Empagliflozin 10 mg|Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255158|NCT02589639|OG002|Outcome|Empagliflozin 25 mg|Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255159|NCT02589639|EG000|Reported Event|Placebo|Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period
11255160|NCT02589639|EG001|Reported Event|Empagliflozin 10 mg|Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255161|NCT02589639|EG002|Reported Event|Empagliflozin 25 mg|Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
11255162|NCT02589665|BG000|Baseline|Induction: Placebo IV Q4W|Placebo administered every 4 weeks (Q4W) intravenously (IV).
11255163|NCT02589665|BG001|Baseline|Induction: 50 mg Mirikizumab IV Q4W|"50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255164|NCT02589665|BG002|Baseline|Induction: 200 mg Mirikizumab IV Q4W|"200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255165|NCT02589665|BG003|Baseline|Induction: 600 mg Mirikizumab IV Q4W|"600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255166|NCT02589665|BG004|Baseline|Total|Total of all reporting groups
11255167|NCT02589665|FG000|Participant Flow|Induction: Placebo IV Q4W|Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
11255168|NCT02589665|FG001|Participant Flow|Induction: 50 mg Mirikizumab IV Q4W|"50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255169|NCT02589665|FG002|Participant Flow|Induction: 200 mg Mirikizumab IV Q4W|"200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255170|NCT02589665|FG003|Participant Flow|Induction: 600 mg Mirikizumab IV Q4W|"600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255171|NCT02589665|FG004|Participant Flow|Maintenance: Placebo SC Q4W|Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
11255172|NCT02589665|FG005|Participant Flow|Maintenance: 200 mg Mirikizumab SC Q4W|Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
11255173|NCT02589665|FG006|Participant Flow|Maintenance: 200 mg Mirikizumab SC Q12W|Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
11255174|NCT02589665|FG007|Participant Flow|Induction Extension: 600mg Mirikizumab IV Q4W|Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
11255175|NCT02589665|FG008|Participant Flow|Induction Extension: 1000mg Mirikizumab IV Q4W|Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
11255176|NCT02589665|FG009|Participant Flow|Maintenance Extension: 200mg Mirikizumab SC Q4W|Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
11255177|NCT02589665|OG000|Outcome|Placebo IV Q4W|Placebo administered every 4 weeks (Q4W) intravenously (IV).
11255178|NCT02589665|OG001|Outcome|50 mg Mirikizumab IV Q4W|"50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255179|NCT02589665|OG002|Outcome|200 mg Mirikizumab IV Q4W|"200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255180|NCT02589665|OG003|Outcome|600 mg Mirikizumab IV Q4W|"600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255181|NCT02589665|OG000|Outcome|Placebo SC Q4W|Placebo administered subcutaneously (SC) Q4W during the maintenance period.
11255182|NCT02589665|OG001|Outcome|200 mg Mirikizumab SC Q4W|200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
11255183|NCT02589665|OG002|Outcome|200 mg Mirikizumab SC Q12W|200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period
11255184|NCT02589665|OG000|Outcome|50 mg Mirikizumab IV Q4W|50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
11255185|NCT02589665|OG001|Outcome|200 mg Mirikizumab IV Q4W|"200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255186|NCT02589665|OG002|Outcome|600 mg Mirikizumab IV Q4W|"600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255187|NCT02589665|OG003|Outcome|200 mg Mirikizumab SC Q4W|200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
11255188|NCT02589665|OG004|Outcome|200 mg Mirikizumab SC Q12W|200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
11255189|NCT02589665|EG000|Reported Event|Induction: Placebo IV Q4W|Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
11255190|NCT02589665|EG001|Reported Event|Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)|"50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255191|NCT02589665|EG002|Reported Event|Induction: 200 mg Mirikizumab IV Q4W|"200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255192|NCT02589665|EG003|Reported Event|Induction: 600 mg Mirikizumab IV Q4W|"600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.~Participants who do not have a clinical response may choose to participate in the unblinded study extension period."
11255193|NCT02589665|EG004|Reported Event|Maintenance: Placebo SC Q4W|Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
11255194|NCT02589665|EG005|Reported Event|Maintenance: 200 mg Mirikizumab SC Q4W|Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
11255195|NCT02589665|EG006|Reported Event|Maintenance: 200 mg Mirikizumab SC Q12W|Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
11255196|NCT02589665|EG007|Reported Event|Induction Extension: 600mg Mirikizumab IV Q4W|Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
11255197|NCT02589665|EG008|Reported Event|Induction Extension:1000mg Mirikizumab IV Q4W|Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) ) once every 4 weeks (Q4W) during the Extension Open-Label.
11255198|NCT02589665|EG009|Reported Event|Maintenance Extension: 200mg Mirikizumab SC Q4W|Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
11255199|NCT02589808|BG000|Baseline|Echocardiography|"Cardiac ultrasound scan.~Echocardiography: Pocket ultrasound device."
11255200|NCT02589808|FG000|Participant Flow|All Participant|All Participant went through on full transthoracic echocardiography then GeVscan
11255201|NCT02589808|OG000|Outcome|Echocardiograph|Fully accredited echocardiography laboratory
11255202|NCT02589808|EG000|Reported Event|Echocardiography|"Cardiac ultrasound scan.~Echocardiography: Pocket ultrasound device."
11255203|NCT02589847|BG000|Baseline|RBX2660 Open-label|"RBX2660 (microbiota suspension)~RBX2660: suspension of intestinal microbes"
11255204|NCT02589847|BG001|Baseline|Historical Control Antibiotics|"Retrospective Historical Control with standard of care~Standard of Care Antibiotics: Standard of Care Antibiotics"
11255205|NCT02589847|BG002|Baseline|Total|Total of all reporting groups
11255206|NCT02589847|FG000|Participant Flow|RBX2660 Open-label|"RBX2660 (microbiota suspension)~RBX2660: suspension of intestinal microbes"
11255207|NCT02589847|FG001|Participant Flow|Historical Control Antibiotics|"Retrospective Historical Control with standard of care~Standard of Care Antibiotics: Standard of Care Antibiotics"
11255208|NCT02589847|OG000|Outcome|RBX2660 Open-label|"RBX2660 (microbiota suspension)~RBX2660: suspension of intestinal microbes"
11255209|NCT02589847|OG001|Outcome|Historical Control Antibiotics|"Retrospective Historical Control with standard of care~Standard of Care Antibiotics: Standard of Care Antibiotics"
11255210|NCT02589847|OG000|Outcome|RBX2660 Open-label|RBX2660 (microbiota suspension)
11255211|NCT02589847|EG000|Reported Event|RBX2660 Open-label|"RBX2660 (microbiota suspension)~RBX2660: suspension of intestinal microbes"
11255212|NCT02589847|EG001|Reported Event|Historical Control Antibiotics|"Retrospective Historical Control with standard of care~Standard of Care Antibiotics: Standard of Care Antibiotics"
11255213|NCT02589977|BG000|Baseline|Normal Participants|"No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255214|NCT02589977|BG001|Baseline|Hypertensive Participants|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255215|NCT02589977|BG002|Baseline|HFpEF Patients|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255216|NCT02589977|BG003|Baseline|Total|Total of all reporting groups
11255217|NCT02589977|FG000|Participant Flow|Normal Participants|"No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255218|NCT02589977|FG001|Participant Flow|Hypertensive Participants|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255219|NCT02589977|FG002|Participant Flow|HFpEF Patients|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255220|NCT02589977|OG000|Outcome|Normal Participants|"No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255221|NCT02589977|OG001|Outcome|Hypertensive Participants|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255222|NCT02589977|OG002|Outcome|HFpEF Patients|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255223|NCT02589977|EG000|Reported Event|Normal Participants|"No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255224|NCT02589977|EG001|Reported Event|Hypertensive Participants|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255225|NCT02589977|EG002|Reported Event|HFpEF Patients|"No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.~Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.~regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants"
11255226|NCT02590003|BG000|Baseline|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
11255227|NCT02590003|BG001|Baseline|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
11255228|NCT02590003|BG002|Baseline|Total|Total of all reporting groups
11255229|NCT02590003|FG000|Participant Flow|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
11255230|NCT02590003|FG001|Participant Flow|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
11255231|NCT02590003|OG000|Outcome|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
11255232|NCT02590003|OG001|Outcome|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
11255233|NCT02590003|EG000|Reported Event|Single Agent Chemotherapy|"-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Nab-paclitaxel"
11255234|NCT02590003|EG001|Reported Event|Platinum-based Doublet Chemotherapy|"Carboplatin AUC 5 30 minute infusion IV on day 1~Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle~Carboplatin~Nab-paclitaxel"
11255235|NCT02590354|BG000|Baseline|All Participants (Both Phase 1 and 2)|114 subjects were screened in phase 1. Only those with a low viral reservoir continued to phase 2 (16 subjects).
11255236|NCT02590354|FG000|Participant Flow|Treatment Interruption|"The ART treatment in patients with a very low viral reservoir will be interrupted.~Phase 1: Screening visit for HIV patients. During this visit a blood sample is taken for HIV reservoir analysis. Patients in which the reservoir is below a certain treshold will continue to phase 2 and will have their ART treatment interrupted (treatment interruption period)."
11255237|NCT02590354|OG000|Outcome|Treatment Interruption|"The ART treatment in patients with a very low viral reservoir will be interrupted.~ART interruption"
11255238|NCT02590354|OG000|Outcome|Phase 2 - Treatment Interruption|The ART treatment in patients with a very low viral reservoir will be interrupted.
11255239|NCT02590354|EG000|Reported Event|Treatment Interruption|Subjects enrolled in phase 2 (treatment interruption). There was no AE collection during phase 1.
11255240|NCT02590406|BG000|Baseline|Beach Chair (BC) and ZEEP|"Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface~Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface"
11255241|NCT02590406|BG001|Baseline|Reverse Trendelenburg and NIPPV|"Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface~Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface"
11255242|NCT02590406|BG002|Baseline|Total|Total of all reporting groups
11255243|NCT02590406|FG000|Participant Flow|Beach Chair (BC) and ZEEP|"Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface~Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface"
11255244|NCT02590406|FG001|Participant Flow|Reverse Trendelenburg and NIPPV|"Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface~Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface"
11255245|NCT02590406|OG000|Outcome|Beach Chair (BC) and ZEEP|"Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface~Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface"
11255246|NCT02590406|OG001|Outcome|Reverse Trendelenburg and NIPPV|"Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface~Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface"
11255247|NCT02590406|EG000|Reported Event|Beach Chair (BC) and ZEEP|"Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface~Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface"
11255248|NCT02590406|EG001|Reported Event|Reverse Trendelenburg and NIPPV|"Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface~Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface"
11255249|NCT02590432|BG000|Baseline|LINZESS® 145 μg (CIC, Open Label)|LINZESS® 145 μg capsules, orally, once daily for up to 52 weeks for participants with CIC. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255250|NCT02590432|BG001|Baseline|LINZESS® 290 μg (IBS-C, Open Label)|LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255251|NCT02590432|BG002|Baseline|Total|Total of all reporting groups
11255252|NCT02590432|FG000|Participant Flow|LINZESS® 145 μg (CIC, Open Label)|LINZESS® 145 μg capsules, orally, once daily for up to 52 weeks for participants with chronic idiopathic constipation (CIC). If an intolerable adverse event (AE) occurred participants could be randomized to the Double-blind Treatment Period.
11255253|NCT02590432|FG001|Participant Flow|LINZESS® 290 μg (IBS-C, Open Label)|LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with irritable bowel syndrome with constipation (IBS-C). If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255254|NCT02590432|FG002|Participant Flow|LINZESS® 290 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 290 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
11255255|NCT02590432|FG003|Participant Flow|LINZESS® 145 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
11255256|NCT02590432|FG004|Participant Flow|LINZESS® 72 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
11255257|NCT02590432|FG005|Participant Flow|LINZESS® 145 μg (CIC, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was reduced to 72 μg, if applicable.
11255258|NCT02590432|FG006|Participant Flow|LINZESS® 72 μg (CIC, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
11255259|NCT02590432|FG007|Participant Flow|LINZESS® 72 μg (CIC, Dose-reduced Open Label)|Following participation in the Double-blind Treatment Period, if an intolerable AE occurred, LINZESS® 72 μg capsules, orally, once daily up to Week 52 for participants with CIC.
11255260|NCT02590432|FG008|Participant Flow|LINZESS® 72 μg (IBS-C, Dose-reduced Open Label)|Following participation in the Double-blind Treatment Period, if an intolerable AE occurred, LINZESS® 72 μg capsules, orally, once daily up to Week 52 for participants with IBS-C.
11255261|NCT02590432|OG000|Outcome|LINZESS® 145 μg (CIC, Open Label)|LINZESS® 145 μg capsules, orally, once daily for up to 52 weeks for participants with CIC. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255262|NCT02590432|OG001|Outcome|LINZESS® 290 μg (IBS-C, Open Label)|LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255263|NCT02590432|OG000|Outcome|LINZESS® 290 μg (IBS-C, Open Label)|LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period.
11255264|NCT02590432|OG000|Outcome|LINZESS® 290 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 290 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
11255265|NCT02590432|OG001|Outcome|LINZESS® 145 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was reduced to Open Label 72 μg, if applicable.
11255266|NCT02590432|OG002|Outcome|LINZESS® 72 μg (IBS-C, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with IBS-C. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
11255267|NCT02590432|OG003|Outcome|LINZESS® 145 μg (CIC, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 145 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was reduced to 72 μg, if applicable.
11255268|NCT02590432|OG004|Outcome|LINZESS® 72 μg (CIC, Double Blind)|Following participation in the Open Label Treatment Period, LINZESS® 72 μg capsules, orally, once daily from double-blind randomization up to Week 52 for participants with CIC. If an intolerable AE occurred, dose was maintained at Open Label 72 μg, if applicable.
11255269|NCT02590432|EG000|Reported Event|LINZESS® 145 μg (CIC)|LINZESS® 145 μg capsules, orally, once daily for up to 52 weeks for participants with CIC. If an Intolerable AE occurred participants could be randomized to the Double-blind Treatment Period (145 μg or 72 μg) or entered the Dose-reduced 72 μg Open Label Period.
11255270|NCT02590432|EG001|Reported Event|LINZESS® 290 μg (IBS-C)|LINZESS® 290 μg capsules, orally, once daily for up to 52 weeks for participants with IBS-C. If an intolerable AE occurred participants could be randomized to the Double-blind Treatment Period (290 μg, 145 μg or 72 μg) or entered the Dose-reduced 72 μg Open Label Period.
11255271|NCT02590562|BG000|Baseline|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
11255272|NCT02590562|FG000|Participant Flow|Overall Population|Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
11255273|NCT02590562|OG000|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
11255274|NCT02590562|OG000|Outcome|Duration of Biological Treatment <3 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months.
11255275|NCT02590562|OG001|Outcome|Duration of Biological Treatment >=3 to <6 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months.
11255276|NCT02590562|OG002|Outcome|Duration of Biological Treatment >=6 to <12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=6 to <12 months.
11255277|NCT02590562|OG003|Outcome|Duration of Biological Treatment >=12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=12 months.
11255278|NCT02590562|OG000|Outcome|Biological Agent as Monotherapy|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs.
11255279|NCT02590562|OG001|Outcome|Biological Agent as Combination With csDMARDs|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent with concomitant csDMARDs.
11255280|NCT02590562|EG000|Reported Event|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
11255281|NCT02590588|BG000|Baseline|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
11255282|NCT02590588|FG000|Participant Flow|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
11255283|NCT02590588|OG000|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
11255284|NCT02590588|EG000|Reported Event|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
11255285|NCT02590939|BG000|Baseline|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
11255286|NCT02590939|BG001|Baseline|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
11255287|NCT02590939|BG002|Baseline|Total|Total of all reporting groups
11255288|NCT02590939|FG000|Participant Flow|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
11255289|NCT02590939|FG001|Participant Flow|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
11255290|NCT02590939|OG000|Outcome|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
11255291|NCT02590939|OG001|Outcome|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
11255292|NCT02590939|EG000|Reported Event|Active Device|"60 minutes of active external trigeminal nerve stimulation with a CEFALY device~CEFALY Active: Active external trigeminal nerve stimulation"
11255293|NCT02590939|EG001|Reported Event|Sham Device|"60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device~CEFALY Placebo: Placebo external trigeminal nerve stimulation"
11255294|NCT02591056|BG000|Baseline|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
11255295|NCT02591056|FG000|Participant Flow|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
11255296|NCT02591056|OG000|Outcome|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
11255297|NCT02591056|EG000|Reported Event|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
11255298|NCT02591238|BG000|Baseline|IVnon-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
11255299|NCT02591238|BG001|Baseline|IIInon-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255300|NCT02591238|BG002|Baseline|IIsmoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
11255301|NCT02591238|BG003|Baseline|Ismoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255302|NCT02591238|BG004|Baseline|Total|Total of all reporting groups
11255303|NCT02591238|FG000|Participant Flow|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
11255304|NCT02591238|FG001|Participant Flow|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255305|NCT02591238|FG002|Participant Flow|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
11255306|NCT02591238|FG003|Participant Flow|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255307|NCT02591238|OG000|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
11255308|NCT02591238|OG001|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255309|NCT02591238|OG002|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
11255310|NCT02591238|OG003|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255311|NCT02591238|EG000|Reported Event|Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
11255312|NCT02591238|EG001|Reported Event|Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255313|NCT02591238|EG002|Reported Event|Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
11255314|NCT02591238|EG003|Reported Event|Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
11255315|NCT02591290|BG000|Baseline|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
11255316|NCT02591290|FG000|Participant Flow|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
11255317|NCT02591290|OG000|Outcome|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
11255318|NCT02591290|EG000|Reported Event|Menactra® Vaccine|Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
11255319|NCT02591511|BG000|Baseline|Health-education App|(1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation.
11255320|NCT02591511|BG001|Baseline|Health Education Manuals|(1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual.
11255321|NCT02591511|BG002|Baseline|Total|Total of all reporting groups
11255322|NCT02591511|FG000|Participant Flow|Health-education App|"assisting the subjects in installing the app onto their personal smartphones;~teaching the patients about the content of the app and explaining its method of operation"
11255323|NCT02591511|FG001|Participant Flow|Health Education Manuals|"giving the stroke-related health education manuals to subjects;~teaching the patients about the content of the manual."
11255324|NCT02591511|OG000|Outcome|Health-education App|(1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation.
11255325|NCT02591511|OG001|Outcome|Health Education Manuals|(1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual.
11255326|NCT02591511|EG000|Reported Event|Health-education App|(1) assisting the subjects in installing the app onto their personal smartphones; (2) teaching the patients about the content of the app and explaining its method of operation
11255327|NCT02591511|EG001|Reported Event|Health Education Manual|(1) giving the stroke-related health education manuals to subjects; (2) teaching the patients about the content of the manual.
11255328|NCT02591537|BG000|Baseline|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
11255329|NCT02591537|BG001|Baseline|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
11255330|NCT02591537|BG002|Baseline|Total|Total of all reporting groups
11255331|NCT02591537|FG000|Participant Flow|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
11255332|NCT02591537|FG001|Participant Flow|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
11255333|NCT02591537|OG000|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
11255334|NCT02591537|OG001|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
11255335|NCT02591537|OG001|Outcome|Standard Tegaderm Dressing|Standard Tegaderm Dresssing will be applied.
11255336|NCT02591537|EG000|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing will be applied.~OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing."
11255337|NCT02591537|EG001|Reported Event|Standard Tegaderm Dressing|Standard Tegaderm Dressing will be applied.
11255338|NCT02592018|BG000|Baseline|Secukinumab|"All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.~Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12."
11255339|NCT02592018|FG000|Participant Flow|Secukinumab|"All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.~Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12."
11255340|NCT02592018|OG000|Outcome|Secukinumab|"All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.~Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12."
11255341|NCT02592018|EG000|Reported Event|Secukinumab|"All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.~Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12."
11255342|NCT02592421|BG000|Baseline|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: SGLT2 inhibitor (dapagliflozin)"
11255343|NCT02592421|BG001|Baseline|Placebo|"Subjects will receive placebo~Placebo: Placebo Comparator"
11255344|NCT02592421|BG002|Baseline|Total|Total of all reporting groups
11255345|NCT02592421|FG000|Participant Flow|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: SGLT2 inhibitor (dapagliflozin)"
11255346|NCT02592421|FG001|Participant Flow|Placebo|"Subjects will receive placebo~Placebo: Placebo Comparator"
11255347|NCT02592421|OG000|Outcome|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: SGLT2 inhibitor (dapagliflozin)"
11255348|NCT02592421|OG001|Outcome|Placebo|"Subjects will receive placebo~Placebo: Placebo Comparator"
11255349|NCT02592421|EG000|Reported Event|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: SGLT2 inhibitor (dapagliflozin)"
11255350|NCT02592421|EG001|Reported Event|Placebo|"Subjects will receive placebo~Placebo: Placebo Comparator"
11255351|NCT02592434|BG000|Baseline|Tofacitinib: Open-Label Phase|Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
11255352|NCT02592434|FG000|Participant Flow|Tofacitinib: Open-Label Phase|Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
11255353|NCT02592434|FG001|Participant Flow|Tofacitinib: Double Blind Phase|Participants who completed open-label phase and achieved at least a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255354|NCT02592434|FG002|Participant Flow|Placebo|Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255355|NCT02592434|OG000|Outcome|Tofacitinib: Double Blind Phase|Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255356|NCT02592434|OG001|Outcome|Placebo|Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255357|NCT02592434|OG000|Outcome|Tofacitinib: Open-Label Phase|Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
11255358|NCT02592434|EG000|Reported Event|Tofacitinib: Open-Label Phase|Participants received tofacitinib 5 mg tablets (for participants >= 40 kg body weight) or tofacitinib 5 mL oral solution (for participants <40 kg body weight), BID, orally for 18 weeks in open-label phase.
11255359|NCT02592434|EG001|Reported Event|Tofacitinib: Double Blind Phase|Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive tofacitinib tablets (for participants >=40 body weight) or oral solution (for participants <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255360|NCT02592434|EG002|Reported Event|Placebo|Participants who completed open-label phase and achieved at least a JIA ACR 30 response in open label phase, were randomized at Week 18 to receive placebo either as oral tablets, (for subjects >=40 body weight) or oral solution (for subjects <40 kg body weight), BID, in double-blind phase for additional 26 weeks (up to Week 44).
11255361|NCT02592447|BG000|Baseline|Cognitive Behavior Therapy (CBT)|"Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions.~Therapy for Targeted Therapy-related Fatigue (TTF): Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime."
11255362|NCT02592447|BG001|Baseline|Wait-List Control Condition (WLC)|"Wait-List Control Condition (WLC) group will not receive therapy sessions and will continue usual care with their providers. This group will be offered the same cognitive behavior therapy as the group receiving the CBT-TTF intervention, after the 18 week study period.~Wait-List Control Condition (WLC): Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue."
11255363|NCT02592447|BG002|Baseline|Total|Total of all reporting groups
11255364|NCT02592447|FG000|Participant Flow|Cognitive Behavior Therapy (CBT)|"Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions.~Therapy for Targeted Therapy-related Fatigue (TTF): Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime."
11255365|NCT02592447|FG001|Participant Flow|Wait-List Control Condition (WLC)|"Wait-List Control Condition (WLC) group will not receive therapy sessions and will continue usual care with their providers. This group will be offered the same cognitive behavior therapy as the group receiving the CBT-TTF intervention, after the 18 week study period.~Wait-List Control Condition (WLC): Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue."
11255366|NCT02592447|OG000|Outcome|Cognitive Behavior Therapy (CBT)|"Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions.~Therapy for Targeted Therapy-related Fatigue (TTF): Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime."
11255367|NCT02592447|OG001|Outcome|Wait-List Control Condition (WLC)|"Wait-List Control Condition (WLC) group will not receive therapy sessions and will continue usual care with their providers. This group will be offered the same cognitive behavior therapy as the group receiving the CBT-TTF intervention, after the 18 week study period.~Wait-List Control Condition (WLC): Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue."
11255368|NCT02592447|EG000|Reported Event|Cognitive Behavior Therapy (CBT)|"Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions.~Therapy for Targeted Therapy-related Fatigue (TTF): Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime."
11255369|NCT02592447|EG001|Reported Event|Wait-List Control Condition (WLC)|"Wait-List Control Condition (WLC) group will not receive therapy sessions and will continue usual care with their providers. This group will be offered the same cognitive behavior therapy as the group receiving the CBT-TTF intervention, after the 18 week study period.~Wait-List Control Condition (WLC): Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue."
11255370|NCT02592486|BG000|Baseline|Simultaneous Administration Group|"The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.~Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously."
11255371|NCT02592486|BG001|Baseline|Sequential Administration Group|"The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.~Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine."
11255372|NCT02592486|BG002|Baseline|Total|Total of all reporting groups
11255373|NCT02592486|FG000|Participant Flow|Simultaneous Administration Group|"The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.~Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously."
11255374|NCT02592486|FG001|Participant Flow|Sequential Administration Group|"The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.~Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine."
11255375|NCT02592486|OG000|Outcome|Simultaneous Administration Group|"The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.~Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously."
11255376|NCT02592486|OG001|Outcome|Sequential Administration Group|"The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.~Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine."
11255377|NCT02592486|EG000|Reported Event|Simultaneous Administration Group|"The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.~Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously."
11255378|NCT02592486|EG001|Reported Event|Sequential Administration Group|"The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.~Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine."
11255379|NCT02592629|BG000|Baseline|no Topical or Subcutaneous Anesthetic|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255380|NCT02592629|BG001|Baseline|Subcutaneous Lidocaine|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255381|NCT02592629|BG002|Baseline|Topical Ethyl Chloride|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~ethyl chloride: topical spray~Kenalog: used with lidocaine in shoulder injection"
11255382|NCT02592629|BG003|Baseline|Total|Total of all reporting groups
11255383|NCT02592629|FG000|Participant Flow|no Topical or Subcutaneous Anesthetic|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255384|NCT02592629|FG001|Participant Flow|Subcutaneous Lidocaine|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255385|NCT02592629|FG002|Participant Flow|Topical Ethyl Chloride|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~ethyl chloride: topical spray~Kenalog: used with lidocaine in shoulder injection"
11255386|NCT02592629|OG000|Outcome|no Topical or Subcutaneous Anesthetic|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255387|NCT02592629|OG001|Outcome|Subcutaneous Lidocaine|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255388|NCT02592629|OG002|Outcome|Topical Ethyl Chloride|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~ethyl chloride: topical spray~Kenalog: used with lidocaine in shoulder injection"
11255389|NCT02592629|EG000|Reported Event|no Topical or Subcutaneous Anesthetic|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255390|NCT02592629|EG001|Reported Event|Subcutaneous Lidocaine|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~Kenalog: used with lidocaine in shoulder injection"
11255391|NCT02592629|EG002|Reported Event|Topical Ethyl Chloride|"Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds~lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection~ethyl chloride: topical spray~Kenalog: used with lidocaine in shoulder injection"
11255392|NCT02592655|BG000|Baseline|One Windlass Tourniquet|Baseline characteristics for participants that received only one windlass tourniquet.
11255393|NCT02592655|BG001|Baseline|Two Windlass Tourniquets|Baseline characteristics for participants who had a second windlass tourniquet applied immediately proximal to the first. Meaning that a single windlass tourniquet did not appear effective.
11255394|NCT02592655|BG002|Baseline|Total|Total of all reporting groups
11255395|NCT02592655|FG000|Participant Flow|All Participants|"Each subject has been randomly allocated to a sequence of interventions. Pneumatic tourniquet with a 10 cm (4 inch) wide cylindrical cuff typically used in surgical settings, and is representative of best outcome.~Windlass Tourniquet: The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.8 cm (1.5 inch) in width. The SOFTT-W is representative of the typical emergency tourniquet. In accordance with current prehospital guidelines: If a single windlass tourniquet not effective then a second windlass tourniquet will be applied immediately proximal to the first.~Tourniquet Tape 10 cm wide and Tourniquet Tape 5 cm wide are elastic adhesive tape tourniquets.~5 cm tape was discontinued after the 4th participant. Once stretched the tape was too narrow for sufficient overlap. Because the overlap was not sufficient the edges began to roll. This would create an unacceptably narrow band if left in place longer than the prescribed time."
11255396|NCT02592655|OG000|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
11255397|NCT02592655|OG001|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
11255398|NCT02592655|OG002|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a one windlass tourniquet to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
11255399|NCT02592655|OG003|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
11255400|NCT02592655|OG000|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
11255401|NCT02592655|OG001|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
11255402|NCT02592655|OG002|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of one windlass tourniquet to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
11255403|NCT02592655|OG003|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of the two windlass tourniquets to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
11255404|NCT02592655|OG004|Outcome|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
11255405|NCT02592655|EG000|Reported Event|Pneumatic Tourniquet|The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) was used with a 10 cm (4 inch) wide pneumatic cuff.
11255406|NCT02592655|EG001|Reported Event|Windlass Tourniquet|One or two windlass tourniquets applied as needed to achieve study objectives.
11255407|NCT02592655|EG002|Reported Event|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
11255408|NCT02592655|EG003|Reported Event|Tourniquet Tape 10 cm|Tourniquet Tape, 10 cm (4 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
11255409|NCT02592798|BG000|Baseline|Abatacept|"Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255410|NCT02592798|BG001|Baseline|Placebo|"Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255411|NCT02592798|BG002|Baseline|Total|Total of all reporting groups
11255412|NCT02592798|FG000|Participant Flow|Abatacept|"Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255413|NCT02592798|FG001|Participant Flow|Placebo|"Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255414|NCT02592798|OG000|Outcome|Abatacept|"Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255415|NCT02592798|OG001|Outcome|Placebo|"Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255416|NCT02592798|OG001|Outcome|Placebo|"Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.~Open Label Period (OLE): Abatacept IV administered every 28 days"
11255417|NCT02592798|OG000|Outcome|Abatacept During Double-Blind Period|Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255418|NCT02592798|OG001|Outcome|Placebo During Double-Blind Period|Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255419|NCT02592798|OG002|Outcome|Abatacept During Cumulative Abatacept Safety Period|Any participants receiving at least 1 dose of Abatacept, starting either in the Double-Blind Period or in the Open Label Period
11255420|NCT02592798|EG000|Reported Event|Abatacept During Double-Blind Period 1 (DB1)|Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255421|NCT02592798|EG001|Reported Event|Placebo During Double-Blind Period 1 (DB1)|Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255422|NCT02592798|EG002|Reported Event|Abatacept During Double-Blind Period 2 (DB2)|Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255423|NCT02592798|EG003|Reported Event|Placebo During Double-Blind Period 2 (DB2)|Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
11255424|NCT02592798|EG004|Reported Event|Abatacept During Open Label Period (OLE)|Abatacept IV administered every 28 days
11255425|NCT02592876|BG000|Baseline|RICE|"Rituximab, ifosfamide, carboplatin, and etoposide~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255426|NCT02592876|BG001|Baseline|19A+RICE|"Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide~denintuzumab mafodotin: Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255427|NCT02592876|BG002|Baseline|Total|Total of all reporting groups
11255428|NCT02592876|FG000|Participant Flow|RICE|"Rituximab, ifosfamide, carboplatin, and etoposide~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255429|NCT02592876|FG001|Participant Flow|19A+RICE|"Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide~denintuzumab mafodotin: Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255430|NCT02592876|OG000|Outcome|RICE|"Rituximab, ifosfamide, carboplatin, and etoposide~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255431|NCT02592876|OG001|Outcome|19A+RICE|"Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide~denintuzumab mafodotin: Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255432|NCT02592876|EG000|Reported Event|RICE|"Rituximab, ifosfamide, carboplatin, and etoposide~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255433|NCT02592876|EG001|Reported Event|19A+RICE|"Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide~denintuzumab mafodotin: Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.~rituximab: 375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles~ifosfamide: 5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles~carboplatin: AUC 5 by IV infusion, every 3 weeks for up to 3 cycles~etoposide: 100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles"
11255434|NCT02593006|BG000|Baseline|Step-Up CTP|Consensus Treatment Plan where subjects begin non biologic DMARD (methotrexate, sulfasalazine, or leflunomide) stepping up to biologic if not improved by 3 months
11255435|NCT02593006|BG001|Baseline|Early Combination CTP|Consensus Treatment Plan where patients start a DMARD(methotrexate, sulfasalazine, or leflunomide) and biologic treatment within one month of each other.
11255436|NCT02593006|BG002|Baseline|Biologic Frist CTP|Consensus Treatment Plan where patients begin Biologic treatment
11255437|NCT02593006|BG003|Baseline|Total|Total of all reporting groups
11255438|NCT02593006|FG000|Participant Flow|Step-Up CTP|Consensus Treatment Plan where subjects begin non biologic DMARD (methotrexate, sulfasalazine, or leflunomide) stepping up to biologic if not improved by 3 months
11255439|NCT02593006|FG001|Participant Flow|Early Combination CTP|Consensus Treatment Plan where patients start a DMARD(methotrexate, sulfasalazine, or leflunomide) and biologic treatment within one month of each other.
11255440|NCT02593006|FG002|Participant Flow|Biologic Frist CTP|Consensus Treatment Plan where patients begin Biologic treatment
11255441|NCT02593006|OG000|Outcome|Step-Up Consensus Treatment Plan (CTP)|Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed
11255442|NCT02593006|OG001|Outcome|Early Combination CTP|Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment
11255443|NCT02593006|OG002|Outcome|Biologic First CTP|Initial therapy with a biologic treatment without a non-biologic DMARD
11255444|NCT02593006|OG000|Outcome|Step-Up CTP|Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed
11255445|NCT02593006|EG000|Reported Event|Step-Up CTP|Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed
11255446|NCT02593006|EG001|Reported Event|Early Combination CTP|Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment
11255447|NCT02593006|EG002|Reported Event|Biologic First CTP|Initial therapy with a biologic treatment without a non-biologic DMARD
11255448|NCT02593032|BG000|Baseline|Randomized Treatment|"Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule.~Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells."
11255449|NCT02593032|BG001|Baseline|Control Arm|Patients in the control arm will receive usual care and can continue using their existing pharmacy.
11255450|NCT02593032|BG002|Baseline|Total|Total of all reporting groups
11255451|NCT02593032|FG000|Participant Flow|Randomized Treatment|"Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule.~Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells."
11255452|NCT02593032|FG001|Participant Flow|Control Arm|Patients in the control arm will receive usual care and can continue using their existing pharmacy.
11255453|NCT02593032|OG000|Outcome|Randomized Treatment|"Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule.~Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells."
11255454|NCT02593032|OG001|Outcome|Control Arm|Patients in the control arm will receive usual care and can continue using their existing pharmacy.
11255455|NCT02593032|EG000|Reported Event|Randomized Treatment|"Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule.~Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells."
11255456|NCT02593032|EG001|Reported Event|Control Arm|Patients in the control arm will receive usual care and can continue using their existing pharmacy.
11255457|NCT02593097|BG000|Baseline|Metformin First, Then Matching Placebo|"Subjects who received Metformin in either the first or last 12 weeks of the study~Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.~Metformin: Metformin 500mg twice daily~Matching Placebo: Matching Placebo twice daily"
11255458|NCT02593097|BG001|Baseline|Matching Placebo First, Then Metformin|"Subjects who received matching placebo either the first or last 12 weeks of the study~Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.~Metformin: Metformin 500mg twice daily~Matching Placebo: Matching Placebo twice daily"
11255459|NCT02593097|BG002|Baseline|Total|Total of all reporting groups
11255460|NCT02593097|FG000|Participant Flow|Metformin First, Then Matching Placebo|"Subjects who received Metformin in either the first or last 12 weeks of the study~Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.~Metformin: Metformin 500mg twice daily~Matching Placebo: Matching Placebo twice daily"
11255461|NCT02593097|FG001|Participant Flow|Matching Placebo First, Then Metformin|"Subjects who received matching placebo either the first or last 12 weeks of the study~Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.~Metformin: Metformin 500mg twice daily~Matching Placebo: Matching Placebo twice daily"
11255462|NCT02593097|OG000|Outcome|Metformin|Subjects who received Metformin in either the first or last 12 weeks of the study
10822098|NCT00074490|BG002|Baseline|Arm IVA (12-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
11255463|NCT02593097|OG001|Outcome|Matching Placebo|Subjects who received matching placebo either the first or last 12 weeks of the study
11255464|NCT02593097|EG000|Reported Event|Metformin|Subjects who received Metformin in either the first or last 12 weeks of the study
11255465|NCT02593097|EG001|Reported Event|Matching Placebo|Subjects who received matching placebo either the first or last 12 weeks of the study
11255466|NCT02593149|BG000|Baseline|Treatment|"ClearGuard HD End Cap~ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub"
11255467|NCT02593149|BG001|Baseline|Control|Tego® connector with the CurosTM for Tego disinfecting port protector
11255468|NCT02593149|BG002|Baseline|Total|Total of all reporting groups
11255469|NCT02593149|FG000|Participant Flow|Treatment|"ClearGuard HD End Cap~ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub"
11255470|NCT02593149|FG001|Participant Flow|Control|Tego® connector with the CurosTM for Tego disinfecting port protector
11255471|NCT02593149|OG000|Outcome|Treatment|"ClearGuard HD End Cap~ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub"
11255472|NCT02593149|OG001|Outcome|Control|Tego® connector with the CurosTM for Tego disinfecting port protector
11255473|NCT02593149|EG000|Reported Event|Treatment|"ClearGuard HD End Cap~ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub"
11255474|NCT02593149|EG001|Reported Event|Control|Tego® connector with the CurosTM for Tego disinfecting port protector
11255475|NCT02593305|BG000|Baseline|Nitrate First Arm|Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.
11255476|NCT02593305|BG001|Baseline|Placebo First Arm|Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.
11255477|NCT02593305|BG002|Baseline|Young Comparison Group|Young control group, used for age-related comparisons. This group did not go through any intervention.
11255478|NCT02593305|BG003|Baseline|Total|Total of all reporting groups
11255479|NCT02593305|FG000|Participant Flow|Nitrate First Arm|Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.
11255480|NCT02593305|FG001|Participant Flow|Placebo First Arm|Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.
11255481|NCT02593305|FG002|Participant Flow|Young Comparison Group|Young subjects only completed a single experimental visit and no intervention. Data from young were used for age-related comparisons at baseline.
11255482|NCT02593305|OG000|Outcome|Nitrate Pre|Subjects randomized to the nitrate group for 4 weeks. Values reflect pre intervention measures.
11255483|NCT02593305|OG001|Outcome|Nitrate Post|Subjects randomized to the nitrate group for 4 weeks. Values reflect post intervention measures.
11255484|NCT02593305|OG002|Outcome|Placebo Pre|Subjects randomized to the placebo group for 4 weeks. Values reflect pre intervention measures.
11255485|NCT02593305|OG003|Outcome|Placebo Post|Subjects randomized to the placebo group for 4 weeks. Values reflect post intervention measures.
11255486|NCT02593305|EG000|Reported Event|Nitrate|Subjects consumed beet root juice with nitrate for 4 weeks.
11255487|NCT02593305|EG001|Reported Event|Placebo|Subjects consumed beet root juice without nitrate (placebo) for 4 weeks.
11255488|NCT02593305|EG002|Reported Event|Young Comparison Group|Subjects completed one single study visit.
11255489|NCT02593318|BG000|Baseline|Part 1 - Oxaloacetate (OAA) 1 Gram/Day|"Participants take 1 gram of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255490|NCT02593318|BG001|Baseline|Part 2 - Oxaloacetate (OAA)2 Gram/Day|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255491|NCT02593318|BG002|Baseline|Total|Total of all reporting groups
11255492|NCT02593318|FG000|Participant Flow|Part 1 - Oxaloacetate (OAA) 1 Gram/Day|"Participants take 1 gram of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255493|NCT02593318|FG001|Participant Flow|Part 2 - Oxaloacetate (OAA)2 Gram/Day|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255494|NCT02593318|OG000|Outcome|Part 1 - Oxaloacetate (OAA) 1 Gram/Day|"Participants take 1 gram of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255495|NCT02593318|OG001|Outcome|Part 2 - Oxaloacetate (OAA)2 Gram/Day|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255496|NCT02593318|OG000|Outcome|Part 1 - Oxaloacetate (OAA) 1 Gram/Day - Baseline|Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Baseline blood sample obtained prior to 500 mg OOA administered
11255497|NCT02593318|OG001|Outcome|Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 60 Minutes Post Administration of Dose|Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Baseline blood sample drawn 60 minutes post administration of dose.
11255498|NCT02593318|OG002|Outcome|Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 90 Minutes Post Administration of Dose|Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn 90 minutes post administration of dose.
11255499|NCT02593318|OG000|Outcome|Oxaloacetate (OAA) 2 Gram/Day - Baseline Blood Sample|"Participants take 2 gram of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn at baseline prior to dose administration."
11255500|NCT02593318|OG001|Outcome|Oxaloacetate (OAA)2 Gram/Day - 60 Minutes Post Administration|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn at 60 minutes post administration of dose."
11255501|NCT02593318|OG002|Outcome|Oxaloacetate (OAA)2 Gram/Day - 90 Minutes Post Administration of Dose|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample to be drawn 90 minutes post administration of dose"
11255502|NCT02593318|EG000|Reported Event|Part 1 - Oxaloacetate (OAA) 1 Gram/Day|"Participants take 1 gram of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255503|NCT02593318|EG001|Reported Event|Part 2 - Oxaloacetate (OAA)2 Gram/Day|"Participants take 2 grams of OAA per day for period of 4 weeks~Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study"
11255504|NCT02593396|BG000|Baseline|Placebo|Placebo BD
11255505|NCT02593396|BG001|Baseline|Active|Bupropion hydrochloride sustained-release 150mg BD
11255506|NCT02593396|BG002|Baseline|Total|Total of all reporting groups
11255507|NCT02593396|FG000|Participant Flow|Placebo|Placebo BD
11255508|NCT02593396|FG001|Participant Flow|Active|Bupropion hydrochloride sustained-release 150mg BD
11255509|NCT02593396|OG000|Outcome|Placebo|Placebo BD
11255510|NCT02593396|OG001|Outcome|Active|Bupropion hydrochloride sustained-release 150mg BD
11255511|NCT02593396|EG000|Reported Event|Placebo|Placebo BD
11255512|NCT02593396|EG001|Reported Event|Active|Bupropion hydrochloride sustained-release 150mg BD
11255513|NCT02593539|BG000|Baseline|All NEMI|Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
11255514|NCT02593539|FG000|Participant Flow|All NEMI|Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
11255515|NCT02593539|OG000|Outcome|All NEMI|Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
10822099|NCT00074490|BG003|Baseline|Arm IVB (6-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11255516|NCT02593539|OG000|Outcome|NEMI 1000 mcg Via DISKUS|Participants were administered NEMI 1000 mcg using DISKUS DPI once daily in the morning.
11255517|NCT02593539|OG001|Outcome|NEMI 700 mcg Via ELLIPTA|Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
11255518|NCT02593539|OG002|Outcome|NEMI 500 mcg Via ELLIPTA|Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
11255519|NCT02593539|EG000|Reported Event|All NEMI|Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
11255520|NCT02593630|BG000|Baseline|Unicirc Circumcision|Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
11255521|NCT02593630|FG000|Participant Flow|Unicirc Circumcision|Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
11255522|NCT02593630|OG000|Outcome|Unicirc Circumcision|Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
11255523|NCT02593630|OG000|Outcome|Unicirc Circumcision|"Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive~Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive"
11255524|NCT02593630|EG000|Reported Event|Unicirc Circumcision|Unicirc circumcision: Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
11255525|NCT02593773|BG000|Baseline|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
11255526|NCT02593773|FG000|Participant Flow|Interferon γ-1b|Subcutaneous (SC) ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
11255527|NCT02593773|OG000|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
11255528|NCT02593773|EG000|Reported Event|Interferon γ-1b|SC ACTIMMUNE® TIW for a total of 26 weeks. The study drug dose was escalated on a weekly basis over the first 4 weeks of treatment (from 10 μg/m² to 25, 50, and 100 μg/m²), based on tolerability, with all participants on a stable tolerated dose by Week 13. Dose may have been reduced, interrupted, or held based on tolerability thereafter.
11255529|NCT02593825|BG000|Baseline|START-Play|Received the START-Play intervention in addition to their usual early intervention and care
11255530|NCT02593825|BG001|Baseline|Business-as-Usual|Received only the usual early intervention and services required due to delays
11255531|NCT02593825|BG002|Baseline|Total|Total of all reporting groups
11255532|NCT02593825|FG000|Participant Flow|START-Play Intervention|"Intervention incorporating cognitive factors & focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.~START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill; the focus is not on a normal"
11255533|NCT02593825|FG001|Participant Flow|Business as Usual|"Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.~Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training"
11255534|NCT02593825|OG000|Outcome|START-Play Intervention|"Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.~START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill."
11255535|NCT02593825|OG001|Outcome|Business as Usual|"Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.~Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training"
11255536|NCT02593825|OG000|Outcome|START-Play|Received the START-Play intervention in addition to their usual early intervention and care
11255537|NCT02593825|OG001|Outcome|Business-as-Usual|Received only the usual early intervention and services required due to delays
11255538|NCT02593825|EG000|Reported Event|START-Play|Received the START-Play intervention in addition to their usual early intervention and care
11255539|NCT02593825|EG001|Reported Event|Business-as-Usual|Received only the usual early intervention and services required due to delays
11255540|NCT02593864|BG000|Baseline|Variable-Stiffness Shoe|"Subjects will wear a load-modifying variable-stiffness shoe for 6 months~Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading"
11255541|NCT02593864|FG000|Participant Flow|Variable-Stiffness Shoe|"Subjects will wear a load-modifying variable-stiffness shoe for 6 months~Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading"
11255542|NCT02593864|OG000|Outcome|Variable-Stiffness Shoe|"Subjects will wear a load-modifying variable-stiffness shoe for 6 months~Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading"
11255543|NCT02593864|EG000|Reported Event|Variable-Stiffness Shoe|"Subjects will wear a load-modifying variable-stiffness shoe for 6 months~Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading"
11286525|NCT02889562|EG001|Reported Event|Warfarin|"While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin.~After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.~Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications."
11286526|NCT02889796|BG000|Baseline|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286527|NCT02889796|BG001|Baseline|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286528|NCT02889796|BG002|Baseline|Adalimumab|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286529|NCT02889796|BG003|Baseline|Placebo|The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
11286530|NCT02889796|BG004|Baseline|Total|Total of all reporting groups
11286531|NCT02889796|FG000|Participant Flow|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286532|NCT02889796|FG001|Participant Flow|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286533|NCT02889796|FG002|Participant Flow|Adalimumab|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11255544|NCT04142242|BG000|Baseline|Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255545|NCT04142242|BG001|Baseline|Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255546|NCT04142242|BG002|Baseline|Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066).
11255547|NCT04142242|BG003|Baseline|Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066).
11255548|NCT04142242|BG004|Baseline|Group 5: Menomune-primed Participants (MET44)|Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255549|NCT04142242|BG005|Baseline|Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255550|NCT04142242|BG006|Baseline|Total|Total of all reporting groups
11255551|NCT04142242|FG000|Participant Flow|Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MEQ00066).
11255552|NCT04142242|FG001|Participant Flow|Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255553|NCT04142242|FG002|Participant Flow|Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066).
11255554|NCT04142242|FG003|Participant Flow|Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066).
11255555|NCT04142242|FG004|Participant Flow|Group 5: Menomune-primed Participants (MET44)|Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255556|NCT04142242|FG005|Participant Flow|Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255557|NCT04142242|OG000|Outcome|Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255558|NCT04142242|OG000|Outcome|Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255559|NCT04142242|OG001|Outcome|Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255560|NCT04142242|OG002|Outcome|Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)|Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255561|NCT04142242|OG003|Outcome|Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)|Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255562|NCT04142242|OG000|Outcome|Group 5: Menomune-primed Participants (MET44)|Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255563|NCT04142242|OG001|Outcome|Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255564|NCT04142242|OG004|Outcome|Group 5: Menomune-primed Participants (MET44)|Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255565|NCT04142242|OG005|Outcome|Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
11255566|NCT04142242|EG000|Reported Event|Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)|Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255567|NCT04142242|EG001|Reported Event|Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)|Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
11255568|NCT04087122|BG000|Baseline|Esophageal Warming|Patients receive the Attune Medical Esophageal Heat Transfer Device
11255569|NCT04087122|FG000|Participant Flow|Esophageal Warming|Patients receive the Attune Medical Esophageal Heat Transfer Device
11255570|NCT04087122|OG000|Outcome|Esophageal Warming|Patients receiving the Attune Medical Esophageal Heat Transfer Device
11255571|NCT04087122|OG000|Outcome|Esophageal Warming|"Patients receiving the Attune Medical Esophageal Heat Transfer Device~Esophageal warming device (Attune Medical, Chicago, IL: Prospective, single center pilot stud"
11255572|NCT04087122|OG000|Outcome|Esophageal Warming|"Patients receive the Attune Medical Esophageal Heat Transfer Device~Esophageal warming device (Attune Medical, Chicago, IL: Prospective, single center pilot stud"
11255573|NCT04087122|EG000|Reported Event|Esophageal Warming|Patients receive the Attune Medical Esophageal Heat Transfer Device
11255574|NCT03990389|BG000|Baseline|No Intervention: Usual Care Group|Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions.
11255575|NCT03990389|BG001|Baseline|Experimental: Chabot Care Group|Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
11255576|NCT03990389|BG002|Baseline|Total|Total of all reporting groups
11255577|NCT03990389|FG000|Participant Flow|No Intervention: Usual Care Group|Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions.
11255578|NCT03990389|FG001|Participant Flow|Experimental: Chabot Care Group|Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
11255579|NCT03990389|OG000|Outcome|No Intervention: Usual Care Group|Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions.
11255580|NCT03990389|OG001|Outcome|Experimental: Chabot Care Group|Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
11255581|NCT03990389|EG000|Reported Event|No Intervention: Usual Care Group|Subjects will undergo screening including Rapid Estimate of Adult Literacy in Medicine (REALM-R) and Edinburgh Postnatal Depression Scale (EPDS) and a few additional questions.
11255582|NCT03990389|EG001|Reported Event|Experimental: Chabot Care Group|Subjects will undergo screening including REALM-R and EPDS and a few additional questions.
11255583|NCT03939312|BG000|Baseline|Atogepant 60 mg|Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
11255584|NCT03939312|FG000|Participant Flow|Atogepant 60 mg|Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
11255585|NCT03939312|OG000|Outcome|Atogepant 60 mg|Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
11255586|NCT03939312|OG000|Outcome|Atogepant 60 mg|Participants received atogepant 60 mg, orally, QD for up to 40 weeks in the open-label treatment period.
11255587|NCT03939312|OG001|Outcome|Safety Follow-up Period|Following the open-label treatment period, participants entered the 4-week safety follow-up period.
11255588|NCT03939312|EG000|Reported Event|Atogepant 60 mg|Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
11255589|NCT03934541|BG000|Baseline|Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
11255590|NCT03934541|BG001|Baseline|Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255591|NCT03934541|BG002|Baseline|Control 1: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255592|NCT03934541|BG003|Baseline|Control 2: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255593|NCT03934541|BG004|Baseline|Total|Total of all reporting groups
11255594|NCT03934541|FG000|Participant Flow|Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
11255595|NCT03934541|FG001|Participant Flow|Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255596|NCT03934541|FG002|Participant Flow|Control 1: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255597|NCT03934541|FG003|Participant Flow|Control 2: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255598|NCT03934541|OG000|Outcome|Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
11255599|NCT03934541|OG001|Outcome|Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255600|NCT03934541|OG002|Outcome|Control 1: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255601|NCT03934541|OG003|Outcome|Control 2: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255602|NCT03934541|EG000|Reported Event|Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
11255603|NCT03934541|EG001|Reported Event|Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)|MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255604|NCT03934541|EG002|Reported Event|Control 1: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255605|NCT03934541|EG003|Reported Event|Control 2: Placebo for MPER-656 mo(0,2,6,12)|Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
11255606|NCT03895034|BG000|Baseline|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
11255607|NCT03895034|FG000|Participant Flow|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
11255608|NCT03895034|OG000|Outcome|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
11255609|NCT03895034|EG000|Reported Event|Light Adjustable Lens (LAL) and Light Delivery Device (LDD)|Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
11255610|NCT03870477|BG000|Baseline|THP Hip Fracture Plating System|"THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures~THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments."
11255611|NCT03870477|FG000|Participant Flow|THP Hip Fracture Plating System|"THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures~THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments."
11255612|NCT03870477|OG000|Outcome|THP Hip Fracture Plating System|"THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures~THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments."
11255613|NCT03870477|EG000|Reported Event|THP Hip Fracture Plating System|"THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures~THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments."
11286534|NCT02889796|FG003|Participant Flow|Placebo to Filgotinib 200 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
11286535|NCT02889796|FG004|Participant Flow|Placebo to Filgotinib 100 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
11286536|NCT02889796|FG005|Participant Flow|Placebo Never Received Filgotinib|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.
11286537|NCT02889796|OG000|Outcome|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.
11286538|NCT02889796|OG001|Outcome|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks
11255614|NCT03351244|BG000|Baseline|BI 409306 25 mg|"1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255615|NCT03351244|BG001|Baseline|BI 409306 50 mg|"1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255616|NCT03351244|BG002|Baseline|Placebo|"1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period."
11255617|NCT03351244|BG003|Baseline|Total|Total of all reporting groups
11255618|NCT03351244|FG000|Participant Flow|BI 409306 25 mg|"1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255619|NCT03351244|FG001|Participant Flow|BI 409306 50 mg|"1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255620|NCT03351244|FG002|Participant Flow|Placebo|"1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period."
11255621|NCT03351244|OG000|Outcome|BI 409306 25 mg|"1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255622|NCT03351244|OG001|Outcome|BI 409306 50 mg|"1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255623|NCT03351244|OG002|Outcome|BI 409306 Pooled|This group included all participants who administered BI 409306 during the study.
11255624|NCT03351244|OG003|Outcome|Placebo|"1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period."
11255625|NCT03351244|EG000|Reported Event|BI 409306 25 mg|"1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255626|NCT03351244|EG001|Reported Event|BI 409306 50 mg|"1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.~Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period."
11255627|NCT03351244|EG002|Reported Event|Placebo|"1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.~Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.~Both withdrawal and taper periods: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal/taper period; 3 tablets of 10 mg placebo q.d. on Day 2-3 of withdrawal/taper period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal/taper period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal/taper period."
11255628|NCT03351244|EG003|Reported Event|Total|All participants randomised in this study.
11255629|NCT03292926|BG000|Baseline|Adductor Canal Block (ACB)|"The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255630|NCT03292926|BG001|Baseline|Adductor Canal Block & IPACK (ACB/IPACK)|"The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255631|NCT03292926|BG002|Baseline|Total|Total of all reporting groups
11255632|NCT03292926|FG000|Participant Flow|Adductor Canal Block (ACB)|"The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255633|NCT03292926|FG001|Participant Flow|Adductor Canal Block & IPACK (ACB/IPACK)|"The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255634|NCT03292926|OG000|Outcome|Adductor Canal Block (ACB)|"The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255635|NCT03292926|OG001|Outcome|Adductor Canal Block & IPACK (ACB/IPACK)|"The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255636|NCT03292926|EG000|Reported Event|Adductor Canal Block (ACB)|"The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255637|NCT03292926|EG001|Reported Event|Adductor Canal Block & IPACK (ACB/IPACK)|"The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.~The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.~Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair~Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks~Dexamethasone: Dexamethasone will be used to prolong block duration"
11255638|NCT03084666|BG000|Baseline|Treatment Group Donor|"The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255639|NCT03084666|BG001|Baseline|Control Group Donor|"Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255640|NCT03084666|BG002|Baseline|Total|Total of all reporting groups
11255641|NCT03084666|FG000|Participant Flow|Treatment Group Donor|"The treatment will receive 200 mmHg of pressure from a Zimmer automatic tourniquet system (ATS) for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255642|NCT03084666|FG001|Participant Flow|Control Group Donor|"Our control group will receive 20 mmHg of pressure from a Zimmer automatic tourniquet system (ATS) for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255643|NCT03084666|OG000|Outcome|Treatment Group Donor|"The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255644|NCT03084666|OG001|Outcome|Control Group Donor|"Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255645|NCT03084666|EG000|Reported Event|Treatment Group Donor|"The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255646|NCT03084666|EG001|Reported Event|Control Group Donor|"Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals.~Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time."
11255647|NCT02982954|BG000|Baseline|Cohort 1|nivolumab 6mg/kg IV plus, ipilimumab 1mg/kg IV Q8 weeks alternating with nivolumab 480 mg IV Q8 weeks, staggered Q 4 weeks
11255648|NCT02982954|BG001|Baseline|Cohort 2|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q3 weeks for 4 doses
11255649|NCT02982954|BG002|Baseline|Cohort 3|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255650|NCT02982954|BG003|Baseline|Cohort 4|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255651|NCT02982954|BG004|Baseline|Total|Total of all reporting groups
11255652|NCT02982954|FG000|Participant Flow|Cohort 1|nivolumab 6mg/kg IV plus, ipilimumab 1mg/kg IV Q8 weeks alternating with nivolumab 480 mg IV Q8 weeks, staggered Q 4 weeks
11255653|NCT02982954|FG001|Participant Flow|Cohort 2|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q3 weeks for 4 doses
11255654|NCT02982954|FG002|Participant Flow|Cohort 3|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255655|NCT02982954|FG003|Participant Flow|Cohort 4|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255656|NCT02982954|OG000|Outcome|Cohort 1|nivolumab 6mg/kg IV plus, ipilimumab 1mg/kg IV Q8 weeks alternating with nivolumab 480 mg IV Q8 weeks, staggered Q 4 weeks
11255657|NCT02982954|OG001|Outcome|Cohort 2|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q3 weeks for 4 doses
11255658|NCT02982954|OG002|Outcome|Cohort 3|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255659|NCT02982954|OG003|Outcome|Cohort 4|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255660|NCT02982954|EG000|Reported Event|COHORT 1|nivolumab 6mg/kg IV plus, ipilimumab 1mg/kg IV Q8 weeks alternating with nivolumab 480 mg IV Q8 weeks, staggered Q 4 weeks
11255661|NCT02982954|EG001|Reported Event|COHORT 2|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q3 weeks for 4 doses
11255662|NCT02982954|EG002|Reported Event|COHORT 3|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255663|NCT02982954|EG003|Reported Event|COHORT 4|nivolumab 3mg/kg IV combined with ipilimumab 1mg/kg IV Q 3 weeks for 4 doses
11255664|NCT02903914|BG000|Baseline|Part 1A - INCB001158 50mg|INCB001158 administered orally at 50mg twice daily (BID) in participants with advanced/metastatic solid tumors.
11255665|NCT02903914|BG001|Baseline|Part 1A - INCB001158 75mg|INCB001158 administered orally at 75mg BID in participants with advanced/metastatic solid tumors.
11255666|NCT02903914|BG002|Baseline|Part 1A and Part 2- INCB001158 100mg|INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
11255667|NCT02903914|BG003|Baseline|Part 1A - INCB001158 150mg|INCB001158 administered orally at 150mg BID in participants with advanced/metastatic solid tumors.
11255668|NCT02903914|BG004|Baseline|Part 1B - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200 mg IV every 3 weeks (Q3W)
11255669|NCT02903914|BG005|Baseline|Part 1B - INCB001158 75mg + Pembrolizumab|INCB001158 administered orally 75mg BID in combination with pembrolizumab at 200 mg IV Q3W
11255670|NCT02903914|BG006|Baseline|Part 1B + Part 3- INCB001158 100mg + Pembrolizumab|INCB001158 administered orally at 100mg twice daily in combination with pembrolizumab at 200 mg IV Q3W.
11255671|NCT02903914|BG007|Baseline|Part 1C - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200mg IV Q3W in participants with Moderately Impaired Renal Function
11255672|NCT02903914|BG008|Baseline|Total|Total of all reporting groups
11255673|NCT02903914|FG000|Participant Flow|Part 1A - INCB001158 50mg|INCB001158 administered orally at 50mg twice daily (BID) in participants with advanced/metastatic solid tumors.
11255674|NCT02903914|FG001|Participant Flow|Part 1A - INCB001158 75mg|INCB001158 administered orally at 75mg BID in participants with advanced/metastatic solid tumors.
11255675|NCT02903914|FG002|Participant Flow|Part 1A and Part 2- INCB001158 100mg|INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
11255676|NCT02903914|FG003|Participant Flow|Part 1A - INCB001158 150mg|INCB001158 administered orally at 150mg BID in participants with advanced/metastatic solid tumors.
11255677|NCT02903914|FG004|Participant Flow|Part 1B - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200 mg IV every 3 weeks (Q3W)
11255678|NCT02903914|FG005|Participant Flow|Part 1B - INCB001158 75mg + Pembrolizumab|INCB001158 administered orally 75mg BID in combination with pembrolizumab at 200 mg IV Q3W
11255679|NCT02903914|FG006|Participant Flow|Part 1B and Part 3- INCB001158 100mg + Pembrolizumab|INCB001158 administered orally at 100mg BID in combination with pembrolizumab at 200 mg IV Q3W.
11255680|NCT02903914|FG007|Participant Flow|Part 1C - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200mg IV Q3W in participants with Moderately Impaired Renal Function
11255681|NCT02903914|OG000|Outcome|Part 1A - INCB001158 50mg|INCB001158 administered orally at 50mg twice daily (BID) in participants with advanced/metastatic solid tumors.
11255682|NCT02903914|OG001|Outcome|Part 1A - INCB001158 75mg|INCB001158 administered orally at 75mg BID in participants with advanced/metastatic solid tumors.
11255683|NCT02903914|OG002|Outcome|Part 1A - INCB001158 100mg|INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
11255684|NCT02903914|OG003|Outcome|Part 1A - INCB001158 150mg|INCB001158 administered orally at 150mg BID in participants with advanced/metastatic solid tumors.
11255685|NCT02903914|OG004|Outcome|Part 1B - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200 mg IV every 3 weeks (Q3W)
11255686|NCT02903914|OG005|Outcome|Part 1B - INCB001158 75mg + Pembrolizumab|INCB001158 administered orally 75mg BID in combination with pembrolizumab at 200 mg IV Q3W
11255687|NCT02903914|OG006|Outcome|Part 1B - INCB001158 100mg + Pembrolizumab|INCB001158 administered orally at 100mg BID in combination with pembrolizumab at 200 mg IV Q3W
11255688|NCT02903914|OG007|Outcome|Part 1C - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200mg IV Q3W in participants with Moderately Impaired Renal Function
11255689|NCT02903914|OG000|Outcome|INCB001158 Was Administered as Monotherapy at 50, 75, 100 and 150 mg Doses.Twice Daily|Monotherapy Part 1a: INCB001158 administered orally in patients with advanced/metastatic solid tumors. Sequential dose escalation of single agent INCB001158 will take place in patients with advanced/metastatic solid tumors.
11255690|NCT02903914|OG000|Outcome|INCB001158 Was Administered as Combination Therapy at 50, 75 and 100 mg Twice Daily|INCB001158 administered orally in patients at 50, 75 and 100 mg doses BID with advanced/metastatic solid tumors in combination with pembrolizumab (200 mg IV Q3W)
11255691|NCT02903914|EG000|Reported Event|Part 1A - INCB001158 50mg|INCB001158 administered orally at 50mg twice daily (BID) in participants with advanced/metastatic solid tumors.
11255692|NCT02903914|EG001|Reported Event|Part 1A - INCB001158 75mg|INCB001158 administered orally at 75mg BID in participants with advanced/metastatic solid tumors.
11255693|NCT02903914|EG002|Reported Event|Part 1A and Part 2- INCB001158 100mg|INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
11255694|NCT02903914|EG003|Reported Event|Part 1A - INCB001158 150mg|INCB001158 administered orally at 150mg BID in participants with advanced/metastatic solid tumors.
11255695|NCT02903914|EG004|Reported Event|Part 1B - INCB001158 50mg + Pembrolizumab|INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200 mg IV every 3 weeks (Q3W)
11255696|NCT02903914|EG005|Reported Event|Part 1B - INCB001158 75mg + Pembrolizumab|INCB001158 administered orally 75mg BID in combination with pembrolizumab at 200 mg IV Q3W
11255697|NCT02903914|EG006|Reported Event|Part 1B and Part 3 - INCB001158 100mg + Pembrolizumab|INCB001158 administered orally at 100mg BID in combination with pembrolizumab at 200 mg IV Q3W.
11255698|NCT02903914|EG007|Reported Event|Total|Total
11255699|NCT02727699|BG000|Baseline|Xanamem™|"Oral Xanamem™ capsules 10mg, to be administered once daily~Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343"
11255700|NCT02727699|BG001|Baseline|Placebo|"Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily~Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules"
11255701|NCT02727699|BG002|Baseline|Total|Total of all reporting groups
11255702|NCT02727699|FG000|Participant Flow|Xanamem™|"Oral Xanamem™ capsules 10mg, to be administered once daily~Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343 (Laboratory code for Xanamem)"
11255703|NCT02727699|FG001|Participant Flow|Placebo|"Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily~Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules"
11255704|NCT02727699|OG000|Outcome|Xanamem™|"Oral Xanamem™ capsules 10mg, to be administered once daily~Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343"
11255705|NCT02727699|OG001|Outcome|Placebo|"Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily~Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules"
11255706|NCT02727699|EG000|Reported Event|Xanamem™|"Oral Xanamem™ capsules 10mg, to be administered once daily~Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343"
11255707|NCT02727699|EG001|Reported Event|Placebo|"Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily~Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules"
11255708|NCT02429375|BG000|Baseline|Dose Level 1: 50mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255709|NCT02429375|BG001|Baseline|Dose Level 2: 70mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255710|NCT02429375|BG002|Baseline|Dose Level 3: 90mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255711|NCT02429375|BG003|Baseline|Total|Total of all reporting groups
11255712|NCT02429375|FG000|Participant Flow|Dose Level 1: 50mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255713|NCT02429375|FG001|Participant Flow|Dose Level 2: 70mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255714|NCT02429375|FG002|Participant Flow|Dose Level 3: 90mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255715|NCT02429375|OG000|Outcome|Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35)|Patients with relapsed or refractory Hodgkin lymphoma will receive brentuximab vedotin combined with mocetinostat.
11255716|NCT02429375|OG000|Outcome|Dose Level 1: 50mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255717|NCT02429375|OG001|Outcome|Dose Level 2: 70mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255718|NCT02429375|OG002|Outcome|Dose Level 3: 90mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255719|NCT02429375|EG000|Reported Event|Dose Level 1: 50mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255720|NCT02429375|EG001|Reported Event|Dose Level 2: 70mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11255721|NCT02429375|EG002|Reported Event|Dose Level 3: 90mg Mocetinostat|Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
11286539|NCT02889796|OG002|Outcome|Adalimumab|Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286540|NCT02889796|OG003|Outcome|Placebo|The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
11286541|NCT02889796|OG000|Outcome|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286542|NCT02889796|OG001|Outcome|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks
11286543|NCT02889796|OG002|Outcome|Adalimumab|Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286544|NCT02889796|OG001|Outcome|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11286545|NCT02889796|OG003|Outcome|Placebo|The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
11286546|NCT02889796|OG003|Outcome|Placebo to Filgotinib 200 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
11286547|NCT02889796|OG004|Outcome|Placebo to Filgotinib 100 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
11286548|NCT02889796|OG003|Outcome|Placebo|The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
11286549|NCT02889796|OG003|Outcome|Placebo|The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants were rerandomized to filgotinib 200 mg or filgotinib 100 mg.
11286550|NCT02889796|OG000|Outcome|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks..
11286551|NCT02889796|OG000|Outcome|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally median exposure of up to 52.1 weeks.
11255722|NCT02230254|BG000|Baseline|PROMUS POREMIER Stent|"Single-arm treatment group receiving interventional PROMUS PRIMIER study stent~Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER"
11255723|NCT02230254|FG000|Participant Flow|PROMUS POREMIER Stent|"Single-arm treatment group receiving interventional PROMUS PRIMIER study stent~Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER"
11255724|NCT02230254|OG000|Outcome|PROMUS POREMIER Stent|"Single-arm treatment group receiving interventional PROMUS PRIMIER study stent~Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER"
11255725|NCT02230254|EG000|Reported Event|PROMUS POREMIER Stent|"Single-arm treatment group receiving interventional PROMUS PRIMIER study stent~Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER"
11255726|NCT01909453|BG000|Baseline|Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)|Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255727|NCT01909453|BG001|Baseline|Part 1: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255728|NCT01909453|BG002|Baseline|Part 1: Vemurafenib 960 mg BID|Participants received 960 mg of LGX818 according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255729|NCT01909453|BG003|Baseline|Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)|Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255730|NCT01909453|BG004|Baseline|Part 2: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255731|NCT01909453|BG005|Baseline|Total|Total of all reporting groups
11255732|NCT01909453|FG000|Participant Flow|Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)|Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255733|NCT01909453|FG001|Participant Flow|Part 1: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255734|NCT01909453|FG002|Participant Flow|Part 1: Vemurafenib 960 mg BID|Participants received 960 mg of LGX818 according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255735|NCT01909453|FG003|Participant Flow|Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)|Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255736|NCT01909453|FG004|Participant Flow|Part 2: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255737|NCT01909453|OG000|Outcome|Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)|Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255738|NCT01909453|OG001|Outcome|Part 1: Vemurafenib 960 mg BID|Participants received 960 mg of LGX818 according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255739|NCT01909453|OG001|Outcome|Part 1: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255740|NCT01909453|OG000|Outcome|Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)|Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255741|NCT01909453|OG001|Outcome|Part 2: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255742|NCT01909453|OG002|Outcome|Part 1 + Part 2: LGX818 300 mg|Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
11255743|NCT01909453|OG002|Outcome|Part 1: Vemurafenib 960 mg BID|Participants received 960 mg of LGX818 according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255744|NCT01909453|OG000|Outcome|Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)|Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255745|NCT01909453|OG003|Outcome|Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)|Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255746|NCT01909453|OG004|Outcome|Part 2: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255747|NCT01909453|OG005|Outcome|Part 1 + Part 2: LGX818 300 mg|Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
11255748|NCT01909453|EG000|Reported Event|Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)|Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255749|NCT01909453|EG001|Reported Event|Part 1: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255750|NCT01909453|EG002|Reported Event|Part 1: Vemurafenib 960 mg BID|Participants received 960 mg of LGX818 according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255751|NCT01909453|EG003|Reported Event|Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)|Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255752|NCT01909453|EG004|Reported Event|Part 2: LGX818 300 mg|Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
11255753|NCT01891396|BG000|Baseline|Hyaluronic Acid and TH (Cingal®)|"Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid and TH"
11255754|NCT01891396|BG001|Baseline|Hyaluronic Acid (Monovisc®)|"Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid"
11255755|NCT01891396|BG002|Baseline|Saline|"Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe~Saline: Saline placebo packaged to look identical to comparator syringes."
11255756|NCT01891396|BG003|Baseline|Total|Total of all reporting groups
11255757|NCT01891396|FG000|Participant Flow|Hyaluronic Acid and TH (Cingal®)|"Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe~Hyaluronic Acid and TH"
11255758|NCT01891396|FG001|Participant Flow|Hyaluronic Acid (Monovisc®)|"Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe~Hyaluronic Acid"
11255759|NCT01891396|FG002|Participant Flow|Saline|"Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe~Saline: Saline placebo packaged to look identical to comparator syringes."
11255760|NCT01891396|OG000|Outcome|Hyaluronic Acid and TH (Cingal®)|"Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid and TH"
11255761|NCT01891396|OG001|Outcome|Hyaluronic Acid (Monovisc®)|"Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid"
11255762|NCT01891396|OG002|Outcome|Saline|"Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe~Saline: Saline placebo packaged to look identical to comparator syringes."
11255763|NCT01891396|OG000|Outcome|Hyaluronic Acid and TH (Cingal®)|"Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid and TH (Cingal®): Injection into knee"
11255764|NCT01891396|OG001|Outcome|Saline|"Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe~Saline: Saline placebo packaged to look identical to comparator syringes. Injection into knee."
11255765|NCT01891396|OG000|Outcome|Hyaluronic Acid and TH (Cingal®)|Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe
11255766|NCT01891396|OG001|Outcome|Hyaluronic Acid (Monovisc®)|Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe
11255767|NCT01891396|EG000|Reported Event|Hyaluronic Acid and TH (Cingal®)|"Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid and TH"
11255768|NCT01891396|EG001|Reported Event|Hyaluronic Acid (Monovisc®)|"Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe~Hyaluronic Acid"
11255769|NCT01891396|EG002|Reported Event|Saline|"Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe~Saline: Saline placebo packaged to look identical to comparator syringes."
11255770|NCT01525901|BG000|Baseline|Study 1: Insulin-Like Growth Factor-1 (IGF-1) Then Normal Saline|Insulin-Like Growth Factor-1 (IGF-1) and then placebo administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.
11255771|NCT01525901|BG001|Baseline|Study 1: Normal Saline Then IGF-1|12 weeks in each treatment arm (placebo and then IGF-1), separated by a 4-week wash-out phase
11255772|NCT01525901|BG002|Baseline|Study 2: Insulin-Like Growth Factor-1 (IGF-1) Then Normal Saline|"Participants who have pathogenic deletions or sequence variants of the SHANK3 gene.~Insulin-Like Growth Factor-1 (IGF-1) and then placebo administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously."
11255773|NCT01525901|BG003|Baseline|Study 2: Normal Saline Then IGF-1|12 weeks in each treatment arm (placebo and then IGF-1), separated by a 4-week wash-out phase
11255774|NCT01525901|BG004|Baseline|Total|Total of all reporting groups
11255775|NCT01525901|FG000|Participant Flow|Study 1: Insulin-Like Growth Factor-1 (IGF-1) Then Normal Saline|Insulin-Like Growth Factor-1 (IGF-1) and then placebo administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.
11255776|NCT01525901|FG001|Participant Flow|Study 1: Normal Saline Then IGF-1|12 weeks in each treatment arm (placebo and then IGF-1), separated by a 4-week wash-out phase
11255777|NCT01525901|FG002|Participant Flow|Study 2: Insulin-Like Growth Factor-1 (IGF-1) Then Normal Saline|Insulin-Like Growth Factor-1 (IGF-1) and then placebo administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.
11255778|NCT01525901|FG003|Participant Flow|Study 2: Normal Saline Then IGF-1|12 weeks in each treatment arm (placebo and then IGF-1), separated by a 4-week wash-out phase
11255779|NCT01525901|OG000|Outcome|Study 1: Insulin-Like Growth Factor-1 (IGF-1)|IGF-1 (Increlex; Ipsen Biopharmaceuticals, Inc) is an aqueous solution for injection containing human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Dose titration was initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily.
11255780|NCT01525901|OG001|Outcome|Study 1: Normal Saline|Placebo consisted of saline prepared in identical bottles by the research pharmacy at Mount Sinai.
11255781|NCT01525901|OG000|Outcome|Study 2: IGF-1|IGF-1 is an aqueous solution for injection containing human insulin-like growth factor-1 (Increlex; Ipsen Biopharmaceuticals, Inc)) produced by recombinant DNA technology. Dose titration was initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Medication was administered subcutaneously twice daily with meals and glucose monitoring was performed by parents prior to each injection and at bedtime.
11255782|NCT01525901|OG001|Outcome|Study 2: Placebo|Placebo consisted of saline prepared in identical bottles by the research pharmacy at Mount Sinai.
11255783|NCT01525901|OG002|Outcome|Study 2: Insulin-Like Growth|IGF-1 is an aqueous solution for injection containing human insulin-like growth factor-1 (Increlex; Ipsen Biopharmaceuticals, Inc)) produced by recombinant DNA technology. Dose titration was initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Medication was administered subcutaneously twice daily with meals and glucose monitoring was performed by parents prior to each injection and at bedtime.
11255784|NCT01525901|OG003|Outcome|Study 2: Normal Saline|Placebo consisted of saline prepared in identical bottles by the research pharmacy at Mount Sinai.
11255785|NCT01525901|EG000|Reported Event|Insulin-Like Growth Factor-1 (IGF-1)|IGF-1 is an aqueous solution for injection containing human insulin-like growth factor-1 (Increlex; Ipsen Biopharmaceuticals, Inc)) produced by recombinant DNA technology. Dose titration was initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Medication was administered subcutaneously twice daily with meals and glucose monitoring was performed by parents prior to each injection and at bedtime.
11255786|NCT01525901|EG001|Reported Event|Normal Saline|Placebo
11255787|NCT01354431|BG000|Baseline|Nivolumab 0.3 mg/kg|Nivolumab 0.3 mg/kg IV Q3W
11255788|NCT01354431|BG001|Baseline|Nivolumab 2 mg/kg|Nivolumab 2 mg/kg IV Q3W
11255789|NCT01354431|BG002|Baseline|Nivolumab 10 mg/kg|Nivolumab 10 mg/kg IV Q3W
11255790|NCT01354431|BG003|Baseline|Total|Total of all reporting groups
11255791|NCT01354431|FG000|Participant Flow|Nivolumab 0.3 mg/kg|Nivolumab 0.3 mg/kg IV Q3W
11255792|NCT01354431|FG001|Participant Flow|Nivolumab 2 mg/kg|Nivolumab 2 mg/kg IV Q3W
11255793|NCT01354431|FG002|Participant Flow|Nivolumab 10 mg/kg|Nivolumab 10 mg/kg IV Q3W
11255794|NCT01354431|OG000|Outcome|Nivolumab 0.3 mg/kg|Nivolumab 0.3 mg/kg IV Q3W
11255795|NCT01354431|OG001|Outcome|Nivolumab 2 mg/kg|Nivolumab 2 mg/kg IV Q3W
11255796|NCT01354431|OG002|Outcome|Nivolumab 10 mg/kg|Nivolumab 10 mg/kg IV Q3W
11255797|NCT01354431|EG000|Reported Event|NIVOLUMAB 0.3 mg/kg|
11255798|NCT01354431|EG001|Reported Event|NIVOLUMAB 2 mg/kg|
11255799|NCT01354431|EG002|Reported Event|NIVOLUMAB 10 mg/kg|
11255800|NCT01003691|BG000|Baseline|RN6G 5 mg/kg|RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255801|NCT01003691|BG001|Baseline|RN6G 10 mg/kg|RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255802|NCT01003691|BG002|Baseline|RN6G 15 mg/kg|RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255803|NCT01003691|BG003|Baseline|Placebo|Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
11255804|NCT01003691|BG004|Baseline|Total|Total of all reporting groups
11255805|NCT01003691|FG000|Participant Flow|RN6G 5 mg/kg|RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255806|NCT01003691|FG001|Participant Flow|RN6G 10 mg/kg|RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255807|NCT01003691|FG002|Participant Flow|RN6G 15 mg/kg|RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255808|NCT01003691|FG003|Participant Flow|Placebo|Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
11255809|NCT01003691|OG000|Outcome|RN6G 5 mg/kg|RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255810|NCT01003691|OG001|Outcome|RN6G 10 mg/kg|RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255811|NCT01003691|OG002|Outcome|RN6G 15 mg/kg|RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255812|NCT01003691|OG003|Outcome|Placebo|Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
11255813|NCT01003691|OG003|Outcome|Placebo|Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
11255814|NCT01003691|EG000|Reported Event|RN6G 5 mg/kg|RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255815|NCT01003691|EG001|Reported Event|RN6G 10 mg/kg|RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255816|NCT01003691|EG002|Reported Event|RN6G 15 mg/kg|RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
11255817|NCT01003691|EG003|Reported Event|Placebo|Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
11255818|NCT02593903|BG000|Baseline|Antibiotics Group|Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
11255819|NCT02593903|BG001|Baseline|No Antibiotics Group|Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
11255820|NCT02593903|BG002|Baseline|Total|Total of all reporting groups
11255821|NCT02593903|FG000|Participant Flow|Antibiotics Group|Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
11255822|NCT02593903|FG001|Participant Flow|No Antibiotics Group|Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
11255823|NCT02593903|OG000|Outcome|Antibiotics Group|Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
11255824|NCT02593903|OG001|Outcome|No Antibiotics Group|Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
11255825|NCT02593903|EG000|Reported Event|Antibiotics Group|Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
11255826|NCT02593903|EG001|Reported Event|No Antibiotics Group|Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
11255827|NCT02594098|BG000|Baseline|Placebo Then Secukinumab|"Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule."
11255828|NCT02594098|BG001|Baseline|Secukinumab Only|"Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48."
11255829|NCT02594098|BG002|Baseline|Total|Total of all reporting groups
11255830|NCT02594098|FG000|Participant Flow|Secukinumab Extrinsic|"Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48."
11255831|NCT02594098|FG001|Participant Flow|Placebo Then Secukinumab Extrinsic|"Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule."
11255832|NCT02594098|OG000|Outcome|Placebo Then Secukinumab for Extrinsic AD|"Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule."
11255833|NCT02594098|OG001|Outcome|Placebo Then Secukinumab for Intrinsic AD|"Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule."
11286552|NCT02889796|EG000|Reported Event|Filgotinib 200 mg|Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11255834|NCT02594098|OG002|Outcome|Secukinumab Only for Extrinsic AD|"Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48."
11255835|NCT02594098|OG003|Outcome|Secukinumab Only for Intrinsic AD|"Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48."
11255836|NCT02594098|EG000|Reported Event|Placebo Then Secukinumab|"Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule."
11255837|NCT02594098|EG001|Reported Event|Secukinumab Only|"Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.~Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.~Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48."
11255838|NCT02594111|BG000|Baseline|Colchicine|"Colchicine 1.8 mg PO over 1 hour~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255839|NCT02594111|BG001|Baseline|Placebo|"Matching placebo~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255840|NCT02594111|BG002|Baseline|Total|Total of all reporting groups
11255841|NCT02594111|FG000|Participant Flow|Colchicine|"Colchicine 1.8 mg PO over 1 hour~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255842|NCT02594111|FG001|Participant Flow|Placebo|"Matching placebo~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255843|NCT02594111|OG000|Outcome|Colchicine|"Colchicine 1.8 mg PO over 1 hour~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255844|NCT02594111|OG001|Outcome|Placebo|"Matching placebo~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255845|NCT02594111|EG000|Reported Event|Colchicine|"Colchicine 1.8 mg PO over 1 hour~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255846|NCT02594111|EG001|Reported Event|Placebo|"Matching placebo~Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour"
11255847|NCT02594163|BG000|Baseline|Rituximab, Bendamustine Control|"Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.~Rituximab~Bendamustine"
11255848|NCT02594163|BG001|Baseline|Brentuximab Vedotin Plus Rituximab Plus Bendamustine|"Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.~Brentuximab Vedotin~Rituximab~Bendamustine"
11255849|NCT02594163|BG002|Baseline|Total|Total of all reporting groups
11255850|NCT02594163|FG000|Participant Flow|Rituximab, Bendamustine Control|"Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.~Rituximab~Bendamustine"
11255851|NCT02594163|FG001|Participant Flow|Brentuximab Vedotin Plus Rituximab Plus Bendamustine|"Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.~Brentuximab Vedotin~Rituximab~Bendamustine"
11255852|NCT02594163|OG000|Outcome|Rituximab, Bendamustine Control|"Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.~Rituximab~Bendamustine"
11255853|NCT02594163|OG001|Outcome|Brentuximab Vedotin Plus Rituximab Plus Bendamustine|"Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.~Brentuximab Vedotin~Rituximab~Bendamustine"
11255854|NCT02594163|EG000|Reported Event|Rituximab, Bendamustine Control|"Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.~Rituximab~Bendamustine"
11255855|NCT02594163|EG001|Reported Event|Brentuximab Vedotin Plus Rituximab Plus Bendamustine|"Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.~Brentuximab Vedotin~Rituximab~Bendamustine"
11255856|NCT02594644|BG000|Baseline|10-minute Incubation With Microneedle Roller & Sham|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11286553|NCT02889796|EG001|Reported Event|Filgotinib 100 mg|Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11255857|NCT02594644|BG001|Baseline|20-minute Incubation With Microneedle Roller & Sham|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255858|NCT02594644|BG002|Baseline|Total|Total of all reporting groups
11255859|NCT02594644|FG000|Participant Flow|10-minute Incubation With Microneedle Roller & Sham|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255860|NCT02594644|FG001|Participant Flow|20-minute Incubation With Microneedle Roller|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255861|NCT02594644|OG000|Outcome|10-minute Incubation With Microneedle Roller|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255862|NCT02594644|OG001|Outcome|20-minute Incubation With Microneedle Roller|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255863|NCT02594644|OG002|Outcome|10-minute Incubation With Sham Microneedles|"10-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255864|NCT02594644|OG003|Outcome|20-minute Incubation With Sham Microneedles|"20-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255865|NCT02594644|OG000|Outcome|Pain_microneedle: 10-minute Incubation With Microneedle Roller|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255866|NCT02594644|OG001|Outcome|Pain_microneedle: 20-minute Incubation With Microneedle Roller|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255867|NCT02594644|OG002|Outcome|Pain_microneedle: 10-minute Incubation With Microneedle Sham|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255868|NCT02594644|OG003|Outcome|Pain_microneedle: 20-minute Incubation With Microneedle Sham|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255869|NCT02594644|OG004|Outcome|Pain_PDT: 10-minute Incubation With Microneedle Sham|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255870|NCT02594644|OG005|Outcome|Pain_PDT: 10-minute Incubation With Microneedle Roller|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255871|NCT02594644|OG006|Outcome|Pain_PDT: 20-minute Incubation With Microneedle Sham|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255872|NCT02594644|OG007|Outcome|Pain_PDT: 20-minute Incubation With Microneedle Roller|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255873|NCT02594644|EG000|Reported Event|10-minute Incubation With Microneedle Roller & Sham|"10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255874|NCT02594644|EG001|Reported Event|20-minute Incubation With Microneedle Roller & Sham|"20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.~Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA"
11255875|NCT02594826|BG000|Baseline|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
11255876|NCT02594826|BG001|Baseline|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
11255877|NCT02594826|BG002|Baseline|Total|Total of all reporting groups
11255878|NCT02594826|FG000|Participant Flow|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
11255879|NCT02594826|FG001|Participant Flow|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
11255880|NCT02594826|OG000|Outcome|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
11255881|NCT02594826|OG001|Outcome|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
11255882|NCT02594826|EG000|Reported Event|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
11255883|NCT02594826|EG001|Reported Event|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
11255884|NCT02595008|BG000|Baseline|DSXS Topical Product Cohort 1|"treatment with DSXS twice daily for 28 days in patients age 18 years and older~DSXS: Active treatment"
11255885|NCT02595008|BG001|Baseline|DSXS Topical Product Cohort 2|"treatment with DSXS twice daily for 28 days in patients age 12-17 years of age~DSXS: Active treatment"
11255886|NCT02595008|BG002|Baseline|Total|Total of all reporting groups
11255887|NCT02595008|FG000|Participant Flow|DSXS Topical Product Cohort 1|"treatment with DSXS twice daily for 28 days in patients age 18 years and older~DSXS: Active treatment"
11255888|NCT02595008|FG001|Participant Flow|DSXS Topical Product Cohort 2|"treatment with DSXS twice daily for 28 days in patients age 12-17 years of age~DSXS: Active treatment"
11255889|NCT02595008|OG000|Outcome|DSXS Topical Product Cohort 1|"treatment with DSXS twice daily for 28 days in patients age 18 years and older~DSXS: Active treatment"
11255890|NCT02595008|OG001|Outcome|DSXS Topical Product Cohort 2|"treatment with DSXS twice daily for 28 days in patients age 12-17 years of age~DSXS: Active treatment"
11255891|NCT02595008|EG000|Reported Event|DSXS Topical Product Cohort 1|"treatment with DSXS twice daily for 28 days in patients age 18 years and older~DSXS: Active treatment"
11255892|NCT02595008|EG001|Reported Event|DSXS Topical Product Cohort 2|"treatment with DSXS twice daily for 28 days in patients age 12-17 years of age~DSXS: Active treatment"
11255893|NCT02595073|BG000|Baseline|DSXS Topical Product|"DSXS Active treatment~DSXS: Active treatment"
11255894|NCT02595073|BG001|Baseline|Placebo Topical Product|"Placebo treatment~Placebo: Placebo treatment"
11255895|NCT02595073|BG002|Baseline|Total|Total of all reporting groups
11255896|NCT02595073|FG000|Participant Flow|DSXS Topical Product|"Desoximetasone (DSXS) Active treatment~DSXS: Active treatment"
11255897|NCT02595073|FG001|Participant Flow|Placebo Topical Product|"Placebo treatment~Placebo: Placebo treatment"
11255898|NCT02595073|OG000|Outcome|DSXS Topical Product|"DSXS Active treatment~DSXS: Active treatment"
11255899|NCT02595073|OG001|Outcome|Placebo Topical Product|"Placebo treatment~Placebo: Placebo treatment"
11255900|NCT02595073|EG000|Reported Event|DSXS Topical Product|"DSXS Active treatment~DSXS: Active treatment"
11255901|NCT02595073|EG001|Reported Event|Placebo Topical Product|"Placebo treatment~Placebo: Placebo treatment"
11255902|NCT02595398|BG000|Baseline|4mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints"
11255903|NCT02595398|BG001|Baseline|Sham Procedure|"Matching suprachoroidal syringe with sham procedure~Sham Procedure: Sham procedure administered at 2 timepoints"
11255904|NCT02595398|BG002|Baseline|Total|Total of all reporting groups
11255905|NCT02595398|FG000|Participant Flow|4mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints"
11255906|NCT02595398|FG001|Participant Flow|Sham Procedure|"Matching suprachoroidal syringe with sham procedure~Sham Procedure: Sham procedure administered at 2 timepoints"
11255907|NCT02595398|OG000|Outcome|4mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints"
11255908|NCT02595398|OG001|Outcome|Sham Procedure|"Matching suprachoroidal syringe with sham procedure~Sham Procedure: Sham procedure administered at 2 timepoints"
11255909|NCT02595398|EG000|Reported Event|4mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints"
11255910|NCT02595398|EG001|Reported Event|Sham Procedure|"Matching suprachoroidal syringe with sham procedure~Sham Procedure: Sham procedure administered at 2 timepoints"
11255911|NCT02595437|BG000|Baseline|Safety Population|All patients enrolled in the study who received any amount of Triferic, regardless of whether the dose was administered intravenously or via dialysate.
11255912|NCT02595437|FG000|Participant Flow|Triferic Via IV and Hemodialysate|Triferic was administered via IV infusion on study Day 1, and then mixed with the liquid bicarbonate and administered via hemodialysate on study Day 3.
11255913|NCT02595437|OG000|Outcome|Triferic 0.07 mg/kg Iron Intravenous: Absolute Value|Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
11255914|NCT02595437|OG001|Outcome|Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected|Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
11255915|NCT02595437|OG000|Outcome|Triferic 2 Micromolar in the Hemodialysate: Absolute Value|Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are the absolute values.
11255916|NCT02595437|OG001|Outcome|Triferic 2 Micromolar in the Hemodialysate: Baseline Corrected|Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are baseline-corrected.
11255917|NCT02595437|OG000|Outcome|Triferic 2 Micromolar Via Hemodialysate: Absolute Value|Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are the absolute values.
11255918|NCT02595437|OG001|Outcome|Triferic 2 Micromolar Via Hemodialysate: Baseline Corrected|Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are baseline-corrected.
11255919|NCT02595437|OG000|Outcome|IV Exposure|Patients in this population had been exposed to Triferic via IV infusion only at the time of onset of the adverse event.
11255920|NCT02595437|OG001|Outcome|IV and Hemodialysate Exposure|Patients in this population had been exposed to Triferic via the IV infusion and via hemodialysate at the time of the onset of the adverse event.
11255921|NCT02595437|EG000|Reported Event|IV Exposure|Patients in this population had received Triferic via IV infusion only at the time of onset of the adverse event.
11255922|NCT02595437|EG001|Reported Event|IV and Hemodialysate Exposure|Patients in this population had received Triferic via IV infusion and via hemodialysate at the time of onset of the adverse event.
11255923|NCT02595450|BG000|Baseline|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
11255924|NCT02595450|FG000|Participant Flow|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
11255925|NCT02595450|OG000|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
11255926|NCT02595450|EG000|Reported Event|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
11255927|NCT02595502|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
11255928|NCT02595502|FG000|Participant Flow|Delefilcon A /Senofilcon A/Delefilcon A|Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
11255929|NCT02595502|FG001|Participant Flow|Senofilcon A/Delefilcon A/Senofilcon A|Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
11255930|NCT02595502|OG000|Outcome|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
11255931|NCT02595502|OG001|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
11255932|NCT02595502|EG000|Reported Event|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
11255933|NCT02595502|EG001|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
11255934|NCT02595528|BG000|Baseline|AGN-190584 Vehicle and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255935|NCT02595528|BG001|Baseline|AGN-190584 Lower Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255936|NCT02595528|BG002|Baseline|AGN-190584 Medium Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255937|NCT02595528|BG003|Baseline|AGN-190584 Higher Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255938|NCT02595528|BG004|Baseline|Total|Total of all reporting groups
11255939|NCT02595528|FG000|Participant Flow|AGN-190584 Vehicle and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255940|NCT02595528|FG001|Participant Flow|AGN-190584 Lower Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255941|NCT02595528|FG002|Participant Flow|AGN-190584 Medium Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255942|NCT02595528|FG003|Participant Flow|AGN-190584 Higher Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255943|NCT02595528|OG000|Outcome|AGN-190584 Vehicle|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255944|NCT02595528|OG001|Outcome|AGN-190584 Lower Dose|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255945|NCT02595528|OG002|Outcome|AGN-190584 Medium Dose|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255946|NCT02595528|OG003|Outcome|AGN-190584 Higher Dose|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255947|NCT02595528|EG000|Reported Event|AGN-190584 Vehicle and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255948|NCT02595528|EG001|Reported Event|AGN-190584 Lower Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11286554|NCT02889796|EG002|Reported Event|Adalimumab|Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.
11255949|NCT02595528|EG002|Reported Event|AGN-190584 Medium Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255950|NCT02595528|EG003|Reported Event|AGN-190584 Higher Dose and AGN-199201|Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
11255951|NCT02595567|BG000|Baseline|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will have and ITPC placed for management of recurrent pleural effusion due to liver disease (hepatic hydrothorax). These patients will have undergone at least one prior thoracentesis that has resulted in improvement in shortness of breath. Pleural fluid studies will demonstrate a transudative process, also consistent with hepatic hydrothorax. All patients will have undergone evaluation by the Hepatology service and will have been deemed eligible for additional treatment, such as liver transplant or TIPS (transjugular intrahepatic portosystemic shunt) procedures.
11255952|NCT02595567|FG000|Participant Flow|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
11255953|NCT02595567|OG000|Outcome|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
11255954|NCT02595567|EG000|Reported Event|ITPC|Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
11255955|NCT02595684|BG000|Baseline|Tadalafil|"Tadalafil capsules~Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days."
11255956|NCT02595684|BG001|Baseline|Placebo|"Calcined magnesia capsules~Placebo: Calcined magnesia capsules: one per day, at night, during 28 days."
11255957|NCT02595684|BG002|Baseline|Total|Total of all reporting groups
11255958|NCT02595684|FG000|Participant Flow|Tadalafil|"Tadalafil capsules~Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days."
11255959|NCT02595684|FG001|Participant Flow|Placebo|"Calcined magnesia capsules~Placebo: Calcined magnesia capsules: one per day, at night, during 28 days."
11255960|NCT02595684|OG000|Outcome|Tadalafil|"Tadalafil capsules~Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days."
11255961|NCT02595684|OG001|Outcome|Placebo|"Calcined magnesia capsules~Placebo: Calcined magnesia capsules: one per day, at night, during 28 days."
11255962|NCT02595684|EG000|Reported Event|Tadalafil|"Tadalafil capsules~Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days."
11255963|NCT02595684|EG001|Reported Event|Placebo|"Calcined magnesia capsules~Placebo: Calcined magnesia capsules: one per day, at night, during 28 days."
11255964|NCT02595723|BG000|Baseline|Ph + Meg, Then Pl + Meg, Then Pl + Pl|"Participants first received pretreatment with Phenytoin 200 mg capsule twice/day for one day. Participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days."
11255965|NCT02595723|BG001|Baseline|Pl + Meg, Then Pl + Pl, Then Ph + Meg|"Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days."
11255966|NCT02595723|BG002|Baseline|Pl + Pl, Then Ph + Meg, Then Pl + Meg|"Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days."
11255967|NCT02595723|BG003|Baseline|Total|Total of all reporting groups
11255968|NCT02595723|FG000|Participant Flow|Ph + Meg, Then Pl + Meg, Then Pl + Pl|"Participants first received pretreatment with Phenytoin 200 mg capsule twice/day for one day. Participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days."
11255969|NCT02595723|FG001|Participant Flow|Pl + Meg, Then Pl + Pl, Then Ph + Meg|"Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days."
11255970|NCT02595723|FG002|Participant Flow|Pl + Pl, Then Ph + Meg, Then Pl + Meg|"Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.~Following first 21-day washout, participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.~Following second 21-day washout, participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days."
11255971|NCT02595723|OG000|Outcome|Phenytoin, Then Megestrol|Participants first received pretreatment with Phenytoin 200 mg capsule twice/day for one day. Participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.
11255972|NCT02595723|OG001|Outcome|Placebo, Then Megestrol|Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.
11255973|NCT02595723|OG002|Outcome|Placebo, Then Placebo|Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.
11255974|NCT02595723|EG000|Reported Event|Phenytoin, Then Megestrol|Participants first received pretreatment with Phenytoin 200 mg capsule twice/day for one day. Participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.
11255975|NCT02595723|EG001|Reported Event|Placebo, Then Megestrol|Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.
11255976|NCT02595723|EG002|Reported Event|Placebo, Then Placebo|Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.
11255977|NCT02595749|BG000|Baseline|Placebo Then Intranasal Oxytocin (40 IU)|Participants received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255978|NCT02595749|BG001|Baseline|Intranasal Oxytocin (40 IU) Then Placebo|Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255979|NCT02595749|BG002|Baseline|Total|Total of all reporting groups
11255980|NCT02595749|FG000|Participant Flow|Placebo Then Intranasal Oxytocin (40 IU)|"Participants received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.~Oxytocin"
11255981|NCT02595749|FG001|Participant Flow|Intranasal Oxytocin (40 IU) Then Placebo|Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255982|NCT02595749|OG000|Outcome|Intranasal Oxytocin (40 IU)|Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255983|NCT02595749|OG001|Outcome|Placebo|Participants received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255984|NCT02595749|EG000|Reported Event|Intranasal Oxytocin (40 IU)|Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255985|NCT02595749|EG001|Reported Event|Placebo|Participants received a single placebo nasal spray (consisting of 4ml sterile saline [Ocean Nasal Spray Solution]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
11255986|NCT02595970|BG000|Baseline|Single Arm Secukinumab|Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
11255987|NCT02595970|FG000|Participant Flow|Single Arm Secukinumab|Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
11255988|NCT02595970|OG000|Outcome|Single Arm Secukinumab|Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
11255989|NCT02595970|EG000|Reported Event|AIN457 300mg|Listed below are the most frequent treatment emergent adverse events irrespective of causality
11255990|NCT02595983|BG000|Baseline|All Patients|All patients who received at least 1 dose of revusiran
11255991|NCT02595983|FG000|Participant Flow|All Patients|All patients who received at least 1 dose of revusiran
11255992|NCT02595983|OG000|Outcome|All Patients|All patients who received at least 1 dose of study drug
11255993|NCT02595983|OG000|Outcome|All Patients|All patients who received at least 1 dose of revusiran
11255994|NCT02595983|EG000|Reported Event|Safety Population|All patients who received at least 1 dose of revusiran
11255995|NCT02596009|BG000|Baseline|Breezhaler/Ellipta/Handihaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11255996|NCT02596009|FG000|Participant Flow|Breezhaler/Ellipta/Handihaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11255997|NCT02596009|FG001|Participant Flow|Breezhaler/Handihaler/Ellipta|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11255998|NCT02596009|FG002|Participant Flow|Ellipta/Breezhaler/Handihaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11255999|NCT02596009|FG003|Participant Flow|Ellipta/Handihaler/Breezhaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256000|NCT02596009|FG004|Participant Flow|Handihaler/Breezhaler/Ellipta|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256001|NCT02596009|FG005|Participant Flow|Handihaler/Ellipta/Breezhaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256002|NCT02596009|OG000|Outcome|Breezhaler®|Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256003|NCT02596009|OG001|Outcome|Ellipta®|Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256004|NCT02596009|OG002|Outcome|Handihaler®|Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256005|NCT02596009|EG000|Reported Event|Breezhaler/Ellipta/Handihaler|Each patient were required to inhale via Breezhaler, Ellipta, and Handihaler in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).
11256006|NCT02596022|BG000|Baseline|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256007|NCT02596022|BG001|Baseline|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256008|NCT02596022|BG002|Baseline|Total|Total of all reporting groups
11256009|NCT02596022|FG000|Participant Flow|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256010|NCT02596022|FG001|Participant Flow|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256011|NCT02596022|OG000|Outcome|CI-581a|CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session
11256012|NCT02596022|OG001|Outcome|CI-581b|CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session
11256013|NCT02596022|EG000|Reported Event|CI-581a First, Followed by CI-581b|"Administration of CI-581a followed 2 weeks later by CI-581b~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256014|NCT02596022|EG001|Reported Event|CI-581b First, Followed by CI-581a|"Administration of CI-581b followed 2 weeks later by CI-581a~CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session~CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session"
11256015|NCT02596230|BG000|Baseline|Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
11256016|NCT02596230|BG001|Baseline|Dabigatran Etexilate (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
11256017|NCT02596230|BG002|Baseline|Dabigatran Etexilate (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
11256018|NCT02596230|BG003|Baseline|Vitamin K Antagonist (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
11256019|NCT02596230|BG004|Baseline|Vitamin K Antagonist (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
11256020|NCT02596230|BG005|Baseline|Total|Total of all reporting groups
11256021|NCT02596230|FG000|Participant Flow|Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
11256022|NCT02596230|FG001|Participant Flow|Dabigatran Etexilate (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
11256023|NCT02596230|FG002|Participant Flow|Dabigatran Etexilate (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
11256024|NCT02596230|FG003|Participant Flow|Vitamin K Antagonist (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
11256025|NCT02596230|FG004|Participant Flow|Vitamin K Antagonist (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
11256026|NCT02596230|OG000|Outcome|All Participants With a DVT and/or PE|All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
11256027|NCT02596230|OG000|Outcome|Dabigatran Etexilate|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
11256028|NCT02596230|OG001|Outcome|Vitamin K Antagonist|Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
11256029|NCT02596230|EG000|Reported Event|Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
11256030|NCT02596230|EG001|Reported Event|Dabigatran Etexilate (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
11256031|NCT02596230|EG002|Reported Event|Dabigatran Etexilate (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
11256032|NCT02596230|EG003|Reported Event|Vitamin K Antagonist (1)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
10822100|NCT00074490|BG004|Baseline|Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
10822101|NCT00074490|BG005|Baseline|Total|Total of all reporting groups
11256033|NCT02596230|EG004|Reported Event|Vitamin K Antagonist (2)|Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
11256034|NCT02596321|BG000|Baseline|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
11256035|NCT02596321|BG001|Baseline|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
11256036|NCT02596321|BG002|Baseline|Total|Total of all reporting groups
11256037|NCT02596321|FG000|Participant Flow|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
11256038|NCT02596321|FG001|Participant Flow|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
11256039|NCT02596321|OG000|Outcome|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
11256040|NCT02596321|OG001|Outcome|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
11256041|NCT02596321|EG000|Reported Event|Mitizax ALK HDM Tablet|"Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)~Mitizax: Allergen extract"
11256042|NCT02596321|EG001|Reported Event|Placebo Tablet|"Placebo tablet~Placebo: Placebo tablet"
11256043|NCT02596451|BG000|Baseline|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
11256044|NCT02596451|BG001|Baseline|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
11256045|NCT02596451|BG002|Baseline|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
11256046|NCT02596451|BG003|Baseline|Total|Total of all reporting groups
11256047|NCT02596451|FG000|Participant Flow|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
11256048|NCT02596451|FG001|Participant Flow|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
11256049|NCT02596451|FG002|Participant Flow|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
11256050|NCT02596451|OG000|Outcome|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
11256051|NCT02596451|OG001|Outcome|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
11256052|NCT02596451|EG000|Reported Event|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
11256053|NCT02596451|EG001|Reported Event|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
11256054|NCT02596451|EG002|Reported Event|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
11256055|NCT02596620|BG000|Baseline|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
11256056|NCT02596620|BG001|Baseline|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
11256057|NCT02596620|BG002|Baseline|Total|Total of all reporting groups
11256058|NCT02596620|FG000|Participant Flow|Sequential Therapy|esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
11256059|NCT02596620|FG001|Participant Flow|Triple Therapy|levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
11256060|NCT02596620|OG000|Outcome|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
11256061|NCT02596620|OG001|Outcome|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
11337377|NCT03583372|OG001|Outcome|52 Weeks Tolterodine ER 4 mg|Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11256062|NCT02596620|EG000|Reported Event|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
11256063|NCT02596620|EG001|Reported Event|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
11256064|NCT02596711|BG000|Baseline|Health Education (HE)|Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256065|NCT02596711|BG001|Baseline|Culturally-Tailored (CT)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256066|NCT02596711|BG002|Baseline|Culturally-Tailored With Adherence Enhancement (CT+AE)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256067|NCT02596711|BG003|Baseline|Total|Total of all reporting groups
11256068|NCT02596711|FG000|Participant Flow|Health Education (HE)|Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256069|NCT02596711|FG001|Participant Flow|Culturally-Tailored (CT)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256070|NCT02596711|FG002|Participant Flow|Culturally-Tailored With Adherence Enhancement (CT+AE)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256071|NCT02596711|OG000|Outcome|Health Education (HE)|Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256072|NCT02596711|OG001|Outcome|Culturally-Tailored (CT)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256073|NCT02596711|OG002|Outcome|Culturally-Tailored With Adherence Enhancement (CT+AE)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256074|NCT02596711|EG000|Reported Event|Health Education (HE)|Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256075|NCT02596711|EG001|Reported Event|Culturally-Tailored (CT)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256076|NCT02596711|EG002|Reported Event|Culturally-Tailored With Adherence Enhancement (CT+AE)|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
11256077|NCT02596750|BG000|Baseline|Microneedle Pretreatment|"One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.~Microneedle Roller: 200-micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller~Topical 4% lidocaine"
11256078|NCT02596750|BG001|Baseline|Sham Microneedle Pretreatment|"One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.~Sham microneedle Roller: Flat roller without microneedles~Topical 4% lidocaine"
11256079|NCT02596750|BG002|Baseline|Total|Total of all reporting groups
11256080|NCT02596750|FG000|Participant Flow|Microneedle Treatment|Microneedle treatments consisted of pre-treatment with 200 micrometer microneedle rollers and then application of topical 4% lidocaine.
11256081|NCT02596750|FG001|Participant Flow|Sham Microneedle|Sham microneedle treatments consisted of pre-treatment with flat microneedle rollers (no needles) and then application of topical 4% lidocaine.
11256082|NCT02596750|OG000|Outcome|Active Comparator: Microneedle Pretreatment 1 Ventral Forearm|One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
11256083|NCT02596750|OG001|Outcome|Sham Comparator: Sham Microneedle Pretreatment|One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
11256084|NCT02596750|OG000|Outcome|Active Comparator: Microneedle Pretreatment One Ventral Forear|One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
11256085|NCT02596750|EG000|Reported Event|Microneedle Pretreatment|"One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.~Microneedle Roller: 200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller~Topical 4% lidocaine"
11256086|NCT02596750|EG001|Reported Event|Sham Microneedle Pretreatment|"One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.~Sham microneedle Roller: Flat roller without microneedles~Topical 4% lidocaine"
11256087|NCT02596854|BG000|Baseline|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
11256088|NCT02596854|FG000|Participant Flow|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
11256089|NCT02596854|OG000|Outcome|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
11256090|NCT02596854|EG000|Reported Event|Neurological MRI|"Image acquired for post processing with synthetic software~Neurological MRI: Neurological MRI image collection"
11256091|NCT02596867|BG000|Baseline|Open Label Single Arm, Drug Propanolol|"2 subjects enrolled and received the experimental drug~propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed"
11256092|NCT02596867|FG000|Participant Flow|Open Label Single Arm, Drug Propanolol|2 subjects enrolled and received the experimental drug propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
11256093|NCT02596867|OG000|Outcome|Open Label Single Arm, Drug Propanolol|We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67
11256094|NCT02596867|OG000|Outcome|Open Label Single Arm, Drug Propanolol|"2 subjects enrolled and received the experimental drug~propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed~Both patients reported no AEs due to treatment during treatment phase"
11256095|NCT02596867|EG000|Reported Event|Open Label Single Arm, Drug Propanolol|"all subjects will receive the experimental drug~propanolol: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed"
11256096|NCT02596893|BG000|Baseline|Placebo|Participants received placebo daily up to week 52.
11256097|NCT02596893|BG001|Baseline|GED-0301 160 mg / GED-0301 40 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 52.
11256098|NCT02596893|BG002|Baseline|GED-0301 160 mg / GED-0301 40 mg|Participants received GED-0301 160 mg daily for 12 weeks, followed by continuous GED-0301 40 mg daily, up to week 52.
11256099|NCT02596893|BG003|Baseline|GED-0301 160 mg / GED-0301 160 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks, up to week 52.
11256100|NCT02596893|BG004|Baseline|Total|Total of all reporting groups
11256101|NCT02596893|FG000|Participant Flow|Placebo|Participants received placebo daily up to week 52.
11256102|NCT02596893|FG001|Participant Flow|GED-0301 160 mg / GED-0301 40 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 52.
11256103|NCT02596893|FG002|Participant Flow|GED-0301 160 mg / GED-0301 40 mg|Participants received GED-0301 160 mg daily for 12 weeks, followed by continuous GED-0301 40 mg daily, up to week 52.
11256104|NCT02596893|FG003|Participant Flow|GED-0301 160 mg / GED-0301 160 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks, up to week 52.
11256105|NCT02596893|OG000|Outcome|Placebo|Participants received placebo daily up to week 52.
11256106|NCT02596893|OG001|Outcome|GED-0301 160 mg / GED-0301 40 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 52.
11256107|NCT02596893|OG002|Outcome|GED-0301 160 mg / GED-0301 40 mg|Participants received GED-0301 160 mg daily for 12 weeks, followed by continuous GED-0301 40 mg daily, up to week 52.
11256108|NCT02596893|OG003|Outcome|GED-0301 160 mg / GED-0301 160 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks, up to week 52.
11256109|NCT02596893|EG000|Reported Event|Placebo|Participants received placebo daily up to week 52.
11256110|NCT02596893|EG001|Reported Event|GED-0301 160 mg / GED-0301 40 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 52.
11256111|NCT02596893|EG002|Reported Event|GED-0301 160 mg / GED-0301 40 mg|Participants received GED-0301 160 mg daily for 12 weeks, followed by continuous GED-0301 40 mg daily, up to week 52.
11256112|NCT02596893|EG003|Reported Event|GED-0301 160 mg / GED-0301 160 mg 4 Week Alt|Participants received GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks, up to week 52.
11256113|NCT02596906|BG000|Baseline|tDCS+Training|"This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks~tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session."
11256114|NCT02596906|BG001|Baseline|Sham tDCS+Training|"This group will receive 20 minutes of sham tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.~Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group."
11256115|NCT02596906|BG002|Baseline|Total|Total of all reporting groups
11256116|NCT02596906|FG000|Participant Flow|tDCS+Training|"This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks~tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session."
11256117|NCT02596906|FG001|Participant Flow|Sham tDCS+Training|"This group will receive 20 minutes of sham tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.~Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group."
11256118|NCT02596906|OG000|Outcome|tDCS+Training|"This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks~tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session."
11256119|NCT02596906|OG001|Outcome|Sham tDCS+Training|"This group will receive 20 minutes of sham tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.~Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group."
11256120|NCT02596906|EG000|Reported Event|tDCS+Training|"This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks~tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session."
11256121|NCT02596906|EG001|Reported Event|Sham tDCS+Training|"This group will receive 20 minutes of sham tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.~Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group."
11256122|NCT02596945|BG000|Baseline|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
11256123|NCT02596945|FG000|Participant Flow|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
11256124|NCT02596945|OG000|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
11256125|NCT02596945|EG000|Reported Event|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
11256126|NCT02596958|BG000|Baseline|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
11256127|NCT02596958|FG000|Participant Flow|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).
11256128|NCT02596958|OG000|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
11256129|NCT02596958|EG000|Reported Event|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
11256130|NCT02596971|BG000|Baseline|Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
11256131|NCT02596971|BG001|Baseline|Atezo-G-CHOP Cohort (Safety Run-In Phase)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
11256132|NCT02596971|BG002|Baseline|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256133|NCT02596971|BG003|Baseline|Total|Total of all reporting groups
11256134|NCT02596971|FG000|Participant Flow|Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
11256135|NCT02596971|FG001|Participant Flow|Atezo-G-CHOP Cohort (Safety Run-In Phase)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
11256136|NCT02596971|FG002|Participant Flow|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256137|NCT02596971|OG000|Outcome|Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
11256138|NCT02596971|OG001|Outcome|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256139|NCT02596971|OG001|Outcome|Atezo-G-CHOP Cohort (Safety Run-In Phase)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
11256140|NCT02596971|OG002|Outcome|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256141|NCT02596971|OG002|Outcome|Atezo-G-CHOP Cohort (Safety Run-In Phase)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
11256142|NCT02596971|OG000|Outcome|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256143|NCT02596971|EG000|Reported Event|Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
11256144|NCT02596971|EG001|Reported Event|Atezo-G-CHOP Cohort (Safety Run-In Phase)|Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
11256145|NCT02596971|EG002|Reported Event|Atezo-R-CHOP Cohort (Expansion Phase)|Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
11256146|NCT02597049|BG000|Baseline|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
11256147|NCT02597049|BG001|Baseline|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
11256148|NCT02597049|BG002|Baseline|Placebo|Placebo given SC QW for 24 weeks.
11256149|NCT02597049|BG003|Baseline|Total|Total of all reporting groups
11256150|NCT02597049|FG000|Participant Flow|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
11256151|NCT02597049|FG001|Participant Flow|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
11256152|NCT02597049|FG002|Participant Flow|Placebo|Placebo given SC QW for 24 weeks.
11256153|NCT02597049|OG000|Outcome|1.5 mg Dulaglutide|Dulaglutide 1.5 mg given SC QW for 24 weeks.
11256154|NCT02597049|OG001|Outcome|0.75 mg Dulaglutide|Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
11256155|NCT02597049|OG002|Outcome|Placebo|Placebo given SC QW for 24 weeks.
11256156|NCT02597049|EG000|Reported Event|1.5 mg Dulaglutide|Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
11256157|NCT02597049|EG001|Reported Event|0.75 mg Dulaglutide|Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
11256158|NCT02597049|EG002|Reported Event|Placebo|Placebo given SC QW for 24 weeks.
11256159|NCT02597101|BG000|Baseline|Placebo|"5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day) and 60 mg placebo tablet twice daily~Metformin: background drug~saxagliptin: background drug~placebo: placebo for AZD9668 to be added to background drugs"
11256160|NCT02597101|BG001|Baseline|AZD9668|"60 mg AZD9668 twice daily in addition to 5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day)~Metformin: background drug~saxagliptin: background drug~AZD9668: study drug"
11256161|NCT02597101|BG002|Baseline|Total|Total of all reporting groups
11256162|NCT02597101|FG000|Participant Flow|Placebo|"5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day) and 60 mg placebo tablet twice daily~Metformin: background drug~saxagliptin: background drug~placebo: placebo for AZD9668 to be added to background drugs"
11256163|NCT02597101|FG001|Participant Flow|AZD9668|"60 mg AZD9668 twice daily in addition to 5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day)~Metformin: background drug~saxagliptin: background drug~AZD9668: study drug"
11256164|NCT02597101|OG000|Outcome|Placebo|"5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day) and 60 mg placebo tablet twice daily~Metformin: background drug~saxagliptin: background drug~placebo: placebo for AZD9668 to be added to background drugs"
11256165|NCT02597101|OG001|Outcome|AZD9668|"60 mg AZD9668 twice daily in addition to 5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day)~Metformin: background drug~saxagliptin: background drug~AZD9668: study drug"
11256166|NCT02597101|EG000|Reported Event|Placebo|"5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day) and 60 mg placebo tablet twice daily~Metformin: background drug~saxagliptin: background drug~placebo: placebo for AZD9668 to be added to background drugs"
11256167|NCT02597101|EG001|Reported Event|AZD9668|"60 mg AZD9668 twice daily in addition to 5 mg saxagliptin, once a day, together with optimised (after titration) metformin (500-2000 mg/day)~Metformin: background drug~saxagliptin: background drug~AZD9668: study drug"
11256168|NCT02597127|BG000|Baseline|Placebo (Single-dose)|Saline subcutaneous administration once at Day 1
11256169|NCT02597127|BG001|Baseline|Inclisiran 200 mg (Single-dose)|200 mg subcutaneous administration once at Day 1
11256170|NCT02597127|BG002|Baseline|Inclisiran 300 mg (Single-dose)|300 mg subcutaneous administration once at Day 1
11256171|NCT02597127|BG003|Baseline|Inclisiran 500 mg (Single-dose)|500 mg subcutaneous administration once at Day 1
11256172|NCT02597127|BG004|Baseline|Placebo (Double-dose)|Saline subcutaneous administration at Day 1 and Day 90
11256173|NCT02597127|BG005|Baseline|Inclisiran 100 mg (Double-dose)|100 mg subcutaneous administration at Day 1 and Day 90
11256174|NCT02597127|BG006|Baseline|Inclisiran 200 mg (Double-dose)|200 mg subcutaneous administration at Day 1 and Day 90
11256175|NCT02597127|BG007|Baseline|Inclisiran 300 mg (Double-dose)|300 mg subcutaneous administration at Day 1 and Day 90
11256176|NCT02597127|BG008|Baseline|Total|Total of all reporting groups
11256177|NCT02597127|FG000|Participant Flow|Inclisiran 200 mg (Single-dose)|200 mg subcutaneous administration once at Day 1
11256178|NCT02597127|FG001|Participant Flow|Inclisiran 300 mg (Single-dose)|300 mg subcutaneous administration once at Day 1
11256179|NCT02597127|FG002|Participant Flow|Inclisiran 500 mg (Single-dose)|500 mg subcutaneous administration once at Day 1
11256180|NCT02597127|FG003|Participant Flow|Placebo (Single-dose)|Saline subcutaneous administration once at Day 1
11256181|NCT02597127|FG004|Participant Flow|Inclisiran 100 mg (Double-dose)|100 mg subcutaneous administration at Day 1 and Day 90
11256182|NCT02597127|FG005|Participant Flow|Inclisiran 200 mg (Double-dose)|200 mg subcutaneous administration at Day 1 and Day 90
11213638|NCT02287896|EG001|Reported Event|IV Arm Roledumab|"Arm with RhD-negative pregnant women who were allocated to the IV route of administration of LFB-R593~Dosage and frequency of administration:~Planned antenatal prophylaxis: A single dose of 300 µg IV of Roledumab at 28 or 29 weeks of gestation.~Antenatal prophylaxis following sensitizing events: One or more dose(s) of 300μg IV anti-RhD antibodies (Rhophylac or Roledumab) based on the Kleihauer-test as soon as possible and no later than 72 hours after event occurrence.~Postnatal prophylaxis: Roledumab should be administered to the mother as soon as possible within 72 hours of delivery of an RhD positive infant.~The postnatal dose must still be given even when antenatal prophylaxis has been administered.~Before Roledumab 300μg IV postnatal administration, a Kleihauer-Betke test will be performed on maternal blood sample taken no earlier than 30 min after delivery in order to determine the volume of foetomaternal hemorrhage."
11213639|NCT02287896|EG002|Reported Event|All Patients|Arm with RhD-negative pregnant women who were allocated to the IV and the IM route of administration of LFB-R593
11213640|NCT02287909|BG000|Baseline|A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213641|NCT02287909|BG001|Baseline|B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213642|NCT02287909|BG002|Baseline|C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213643|NCT02287909|BG003|Baseline|D) Continue Ticagrelor MD 90mg Twice Daily|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Ticagrelor: Continue treatment with ticagrelor"
11213644|NCT02287909|BG004|Baseline|Total|Total of all reporting groups
11213645|NCT02287909|FG000|Participant Flow|A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213646|NCT02287909|FG001|Participant Flow|B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213647|NCT02287909|FG002|Participant Flow|C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213648|NCT02287909|FG003|Participant Flow|D) Continue Ticagrelor MD 90mg Twice Daily|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Ticagrelor: Continue treatment with ticagrelor"
11213649|NCT02287909|OG000|Outcome|A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213650|NCT02287909|OG001|Outcome|B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213651|NCT02287909|OG002|Outcome|C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213652|NCT02287909|OG003|Outcome|D) Continue Ticagrelor MD 90mg Twice Daily|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Ticagrelor: Continue treatment with ticagrelor"
11256183|NCT02597127|FG006|Participant Flow|Inclisiran 300 mg (Double-dose)|300 mg subcutaneous administration at Day 1 and Day 90
11256184|NCT02597127|FG007|Participant Flow|Placebo (Double-dose)|Saline subcutaneous administration at Day 1 and Day 90
11256185|NCT02597127|OG000|Outcome|Placebo (Single Dose)|Saline via subcutaneous injection - Single Dose on Day 1
11256186|NCT02597127|OG001|Outcome|200 mg (Single Dose)|200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
11256187|NCT02597127|OG002|Outcome|300 mg (Single Dose)|300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
11256188|NCT02597127|OG003|Outcome|500 mg (Single Dose)|500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
11256189|NCT02597127|OG004|Outcome|Placebo (Double Dose)|Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
11256190|NCT02597127|OG005|Outcome|100 mg (Double Dose)|100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
11256191|NCT02597127|OG006|Outcome|200 mg (Double Dose)|200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
11256192|NCT02597127|OG007|Outcome|300 mg (Double Dose)|300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
11256193|NCT02597127|OG000|Outcome|Single Dose 500 mg|500 mg subcutaneous injection - Single Dose on Day 1 (2 injections)
11256194|NCT02597127|OG001|Outcome|Double Dose 100 mg|200 mg Inclisiran via subcutaneous injection - Two Doses (Day 1 and Day 90)
11256195|NCT02597127|OG002|Outcome|Single and Double Dose Placebo|Saline: Single Dose (Day 1) or Two Doses (Day 1 and Day 90)
11256196|NCT02597127|OG003|Outcome|Single and Double Dose 200 mg|200 mg Inclisiran via subcutaneous injection: Single Dose (Day 1) or Two Doses (Day 1 and Day 90)
11256197|NCT02597127|OG004|Outcome|Single and Double Dose 300 mg|300 mg Inclisiran via subcutaneous injection: Single Dose (Day 1) or Two Doses (Day 1 and Day 90)
11256198|NCT02597127|OG000|Outcome|Placebo (Single Dose)|Saline subcutaneous administration once at Day 1
11256199|NCT02597127|OG001|Outcome|Inclisiran 200 mg (Single Dose)|200 mg subcutaneous administration once at Day 1
11256200|NCT02597127|OG002|Outcome|Inclisiran 300 mg (Single Dose)|300 mg subcutaneous administration once at Day 1
11256201|NCT02597127|OG003|Outcome|Inclisiran 500 mg (Single Dose)|500 mg subcutaneous administration once at Day 1
11256202|NCT02597127|OG004|Outcome|Placebo (Double Dose)|Saline subcutaneous administration twice at Day 1 and Day 90
11256203|NCT02597127|OG005|Outcome|Inclisiran 100 mg (Double Dose)|100 mg subcutaneous administration twice at Day 1 and Day 90
11256204|NCT02597127|OG006|Outcome|Inclisiran 200 mg (Double Dose)|200 mg subcutaneous administration twice at Day 1 and Day 90
11256205|NCT02597127|OG007|Outcome|Inclisiran 300 mg (Double Dose)|300 mg subcutaneous administration twice at Day 1 and Day 90
11256206|NCT02597127|OG000|Outcome|Placebo (Single-dose)|Saline subcutaneous administration once at Day 1
11256207|NCT02597127|OG001|Outcome|Inclisiran 200 mg (Single-dose)|200 mg subcutaneous administration once at Day 1
11256208|NCT02597127|OG002|Outcome|Inclisiran 300 mg (Single-dose)|300 mg subcutaneous administration once at Day 1
11256209|NCT02597127|OG003|Outcome|Inclisiran 500 mg (Single-dose)|500 mg subcutaneous administration once at Day 1
11256210|NCT02597127|OG004|Outcome|Placebo (Double-dose)|Saline subcutaneous administration at Day 1 and Day 90
11256211|NCT02597127|OG005|Outcome|Inclisiran 100 mg (Double-dose)|100 mg subcutaneous administration at Day 1 and Day 90
11256212|NCT02597127|OG006|Outcome|Inclisiran 200 mg (Double-dose)|200 mg subcutaneous administration at Day 1 and Day 90
11256213|NCT02597127|OG007|Outcome|Inclisiran 300 mg (Double-dose)|300 mg subcutaneous administration at Day 1 and Day 90
11256214|NCT02597127|EG000|Reported Event|Placebo (Single Dose)|Saline subcutaneous administration once at Day 1
11256215|NCT02597127|EG001|Reported Event|Inclisiran 200 mg (Single Dose)|200 mg subcutaneous administration once at Day 1
11256216|NCT02597127|EG002|Reported Event|Inclisiran 300 mg (Single Dose)|300 mg subcutaneous administration once at Day 1
11256217|NCT02597127|EG003|Reported Event|Inclisiran 500 mg (Single Dose)|500 mg subcutaneous administration once at Day 1
11256218|NCT02597127|EG004|Reported Event|Placebo (Double Dose)|Saline subcutaneous administration twice at Day 1 and Day 90
11256219|NCT02597127|EG005|Reported Event|Inclisiran 100 mg (Double Dose)|100 mg subcutaneous administration twice at Day 1 and Day 90
11256220|NCT02597127|EG006|Reported Event|Inclisiran 200 mg (Double Dose)|200 mg subcutaneous administration twice at Day 1 and Day 90
11256221|NCT02597127|EG007|Reported Event|Inclisiran 300 mg (Double Dose)|300 mg subcutaneous administration twice at Day 1 and Day 90
11256222|NCT02597452|BG000|Baseline|Intelligent Breast Exam, iBE|"Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.~intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit."
11256223|NCT02597452|FG000|Participant Flow|Intelligent Breast Exam, iBE|"Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.~intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit."
11256224|NCT02597452|OG000|Outcome|Intelligent Breast Exam, iBE|"Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.~intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit."
11256225|NCT02597452|EG000|Reported Event|Intelligent Breast Exam, iBE|"Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.~intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit."
11256226|NCT02597478|BG000|Baseline|Intervention Group (High Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
11256227|NCT02597478|BG001|Baseline|Controlled Group (Low Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
11256228|NCT02597478|BG002|Baseline|Total|Total of all reporting groups
11256229|NCT02597478|FG000|Participant Flow|Intervention Group (High Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
11256230|NCT02597478|FG001|Participant Flow|Controlled Group (Low Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
11256231|NCT02597478|OG000|Outcome|Intervention Group (High Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
11256232|NCT02597478|OG001|Outcome|Controlled Group (Low Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
11256233|NCT02597478|EG000|Reported Event|Intervention Group (High Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
11256234|NCT02597478|EG001|Reported Event|Controlled Group (Low Dose Fentanyl Sublingual Spray)|Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
11256235|NCT02597543|BG000|Baseline|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256236|NCT02597543|BG001|Baseline|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256237|NCT02597543|BG002|Baseline|Total|Total of all reporting groups
11256238|NCT02597543|FG000|Participant Flow|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256239|NCT02597543|FG001|Participant Flow|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256240|NCT02597543|OG000|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256241|NCT02597543|OG001|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256242|NCT02597543|EG000|Reported Event|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256243|NCT02597543|EG001|Reported Event|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.~Regadenoson: For use in stress myocardial perfusion imaging.~Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.~Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
11256244|NCT02597582|BG000|Baseline|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256245|NCT02597582|BG001|Baseline|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
11256246|NCT02597582|BG002|Baseline|Total|Total of all reporting groups
11256247|NCT02597582|FG000|Participant Flow|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256248|NCT02597582|FG001|Participant Flow|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
11256249|NCT02597582|OG000|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256250|NCT02597582|OG001|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
11256251|NCT02597582|OG000|Outcome|Ligusure Assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256252|NCT02597582|OG001|Outcome|Conventional Neck Dissection|"The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256253|NCT02597582|EG000|Reported Event|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
11256254|NCT02597582|EG001|Reported Event|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
11256255|NCT02597673|BG000|Baseline|Standard Rehabilitation Protocol|Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
11256256|NCT02597673|BG001|Baseline|Self-Managed NMES Program|"Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11286555|NCT02889796|EG003|Reported Event|Placebo to Filgotinib 200 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
11256257|NCT02597673|BG002|Baseline|Self-Managed TENS Program|"Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256258|NCT02597673|BG003|Baseline|Combined NMES/TENS Program|"The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256259|NCT02597673|BG004|Baseline|Total|Total of all reporting groups
11256260|NCT02597673|FG000|Participant Flow|Standard Rehabilitation Protocol|Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
11256261|NCT02597673|FG001|Participant Flow|Self-Managed NMES Program|"Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256262|NCT02597673|FG002|Participant Flow|Self-Managed TENS Program|"Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256263|NCT02597673|FG003|Participant Flow|Combined NMES/TENS Program|"The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256264|NCT02597673|OG000|Outcome|Standard Rehabilitation Protocol|Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
11256265|NCT02597673|OG001|Outcome|Self-Managed NMES Program|"Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11337401|NCT03583606|BG001|Baseline|ChAd3-EBO-Z + ChAd3-EBO-Z|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10^11 vp) intramuscularly into the opposite arm on Day 8.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp))."
10848078|NCT00288067|OG000|Outcome|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
10848079|NCT00288067|OG000|Outcome|Fenretinide and Rituximab (Rituximab Naive)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
11213653|NCT02287909|EG000|Reported Event|A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213654|NCT02287909|EG001|Reported Event|B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213655|NCT02287909|EG002|Reported Event|C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Clopidogrel: Swiching from ticagrelor to clopidogrel"
11213656|NCT02287909|EG003|Reported Event|D) Continue Ticagrelor MD 90mg Twice Daily|"Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily~Ticagrelor: Continue treatment with ticagrelor"
11213657|NCT02287922|BG000|Baseline|ALX-0061 150 mg q4w|"ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213658|NCT02287922|BG001|Baseline|ALX-0061 150 mg q2w|"ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213659|NCT02287922|BG002|Baseline|ALX-0061 225 mg q2w|"ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061"
11213660|NCT02287922|BG003|Baseline|TCZ 162 mg q1w or q2w|"Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).~Tocilizumab"
11213661|NCT02287922|BG004|Baseline|Total|Total of all reporting groups
11213662|NCT02287922|FG000|Participant Flow|ALX-0061 150 mg q4w|"ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213663|NCT02287922|FG001|Participant Flow|ALX-0061 150 mg q2w|"ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213664|NCT02287922|FG002|Participant Flow|ALX-0061 225 mg q2w|"ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061"
11213665|NCT02287922|FG003|Participant Flow|TCZ 162 mg q1w or q2w|"Open-label tocilizumab (TCZ). Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).~Tocilizumab"
11213666|NCT02287922|OG000|Outcome|ALX-0061 150 mg q4w|"ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213667|NCT02287922|OG001|Outcome|ALX-0061 150 mg q2w|"ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213668|NCT02287922|OG002|Outcome|ALX-0061 225 mg q2w|"ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061"
11213669|NCT02287922|OG003|Outcome|TCZ 162 mg q1w or q2w|"Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).~Tocilizumab"
11213670|NCT02287922|OG003|Outcome|ALX-0061 Total|This group includes all participants who received at least one dose of ALX-0061
11213671|NCT02287922|EG000|Reported Event|ALX-0061 150 mg q4w|"ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213672|NCT02287922|EG001|Reported Event|ALX-0061 150 mg q2w|"ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061~Placebo"
11213673|NCT02287922|EG002|Reported Event|ALX-0061 225 mg q2w|"ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.~ALX-0061"
11213674|NCT02287922|EG003|Reported Event|TCZ 162 mg q1w or q2w|"Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).~Tocilizumab"
11213675|NCT02288091|BG000|Baseline|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
11256266|NCT02597673|OG002|Outcome|Self-Managed TENS Program|"Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256267|NCT02597673|OG003|Outcome|Combined NMES/TENS Program|"The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256268|NCT02597673|OG002|Outcome|Self-Managed TENS Program|Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
11256269|NCT02597673|EG000|Reported Event|Standard Rehabilitation Protocol|Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
11256270|NCT02597673|EG001|Reported Event|Self-Managed NMES Program|"Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256271|NCT02597673|EG002|Reported Event|Self-Managed TENS Program|"Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256272|NCT02597673|EG003|Reported Event|Combined NMES/TENS Program|"The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.~Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats."
11256273|NCT02597712|BG000|Baseline|Treatment|"Patients will take 25 mg YF476 once daily for 12 weeks~YF476: gastrin receptor antagonist"
11256274|NCT02597712|BG001|Baseline|YF476 Placebo|"Patients will take matching placebo once daily for 12 weeks~YF476 placebo: placebo"
11256275|NCT02597712|BG002|Baseline|Total|Total of all reporting groups
11256276|NCT02597712|FG000|Participant Flow|Treatment|"Patients will take 25 mg YF476 once daily for 12 weeks~YF476: gastrin receptor antagonist"
11256277|NCT02597712|FG001|Participant Flow|YF476 Placebo|"Patients will take matching placebo once daily for 12 weeks~YF476 placebo: placebo"
11256278|NCT02597712|OG000|Outcome|Treatment|"Patients will take 25 mg YF476 once daily for 12 weeks~YF476: gastrin receptor antagonist"
11256279|NCT02597712|OG001|Outcome|YF476 Placebo|"Patients will take matching placebo once daily for 12 weeks~YF476 placebo: placebo"
11256280|NCT02597712|EG000|Reported Event|Treatment|"Patients will take 25 mg YF476 once daily for 12 weeks~YF476: gastrin receptor antagonist"
11256281|NCT02597712|EG001|Reported Event|YF476 Placebo|"Patients will take matching placebo once daily for 12 weeks~YF476 placebo: placebo"
11256282|NCT02597855|BG000|Baseline|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
10848080|NCT00288067|OG001|Outcome|Fenretinide and Rituximab (Rituximab Pre Treated)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
11256283|NCT02597855|BG001|Baseline|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256284|NCT02597855|BG002|Baseline|Total|Total of all reporting groups
11256285|NCT02597855|FG000|Participant Flow|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256286|NCT02597855|FG001|Participant Flow|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256287|NCT02597855|OG000|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256288|NCT02597855|OG001|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256289|NCT02597855|EG000|Reported Event|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256290|NCT02597855|EG001|Reported Event|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
11256291|NCT02597907|BG000|Baseline|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
11256292|NCT02597907|BG001|Baseline|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
11256293|NCT02597907|BG002|Baseline|Total|Total of all reporting groups
11256294|NCT02597907|FG000|Participant Flow|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
11256295|NCT02597907|FG001|Participant Flow|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
11256296|NCT02597907|OG000|Outcome|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
11256297|NCT02597907|OG001|Outcome|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
11256298|NCT02597907|EG000|Reported Event|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
11256299|NCT02597907|EG001|Reported Event|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
11256300|NCT02597920|BG000|Baseline|Cohort A Pradaxa®|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256301|NCT02597920|BG001|Baseline|Cohort B Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256302|NCT02597920|BG002|Baseline|Cohort B VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11256303|NCT02597920|BG003|Baseline|Total|Total of all reporting groups
11256304|NCT02597920|FG000|Participant Flow|Cohort A Pradaxa®|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256305|NCT02597920|FG001|Participant Flow|Cohort B Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256306|NCT02597920|FG002|Participant Flow|Cohort B VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11256307|NCT02597920|OG000|Outcome|Cohort A Pradaxa®|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256308|NCT02597920|OG000|Outcome|Cohort B Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256309|NCT02597920|OG001|Outcome|Cohort B VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11256310|NCT02597920|OG001|Outcome|Cohort B Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256311|NCT02597920|OG002|Outcome|Cohort B VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11256312|NCT02597920|EG000|Reported Event|Cohort A Pradaxa®|Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256313|NCT02597920|EG001|Reported Event|Cohort B Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
11256314|NCT02597920|EG002|Reported Event|Cohort B VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11256315|NCT02597933|BG000|Baseline|Placebo|Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256316|NCT02597933|BG001|Baseline|Nintedanib|Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256317|NCT02597933|BG002|Baseline|Total|Total of all reporting groups
11256318|NCT02597933|FG000|Participant Flow|Placebo|Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256319|NCT02597933|FG001|Participant Flow|Nintedanib|Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256320|NCT02597933|OG000|Outcome|Placebo|Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256321|NCT02597933|OG001|Outcome|Nintedanib|Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
10848081|NCT00288067|EG000|Reported Event|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
11256322|NCT02597933|EG000|Reported Event|Placebo|Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256323|NCT02597933|EG001|Reported Event|Nintedanib|Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.
11256324|NCT02597946|BG000|Baseline|Afatinib 40 mg (Part A)|Patients were orally administered 40 milligram (mg) Afatinib film-coated tablets daily starting dose, once daily continuous (possible escalation to 50 mg, and reduction to 30 mg in the first step, and to 20 mg in the second step) until disease progression or intolerable toxicity or withdrawal of consent for any reason.
11256325|NCT02597946|FG000|Participant Flow|Afatinib 40 mg (Part A)|Patients were orally administered 40 milligram (mg) Afatinib film-coated tablets daily starting dose, once daily continuous (possible escalation to 50 mg, and reduction to 30 mg in the first step, and to 20 mg in the second step) until disease progression or intolerable toxicity or withdrawal of consent for any reason.
11256326|NCT02597946|OG000|Outcome|Afatinib 40 mg (Part A)|Patients were orally administered 40 milligram (mg) Afatinib film-coated tablets daily starting dose, once daily continuous (possible escalation to 50 mg, and reduction to 30 mg in the first step, and to 20 mg in the second step) until disease progression or intolerable toxicity or withdrawal of consent for any reason.
11256327|NCT02597946|EG000|Reported Event|Afatinib 40 mg (Part A)|Patients were orally administered 40 milligram (mg) Afatinib film-coated tablets daily starting dose, once daily continuous (possible escalation to 50 mg, and reduction to 30 mg in the first step, and to 20 mg in the second step) until disease progression or intolerable toxicity or withdrawal of consent for any reason.
11256328|NCT02598076|BG000|Baseline|Control|"Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256329|NCT02598076|BG001|Baseline|Motivational Interviewing|"Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.~Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.~motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256330|NCT02598076|BG002|Baseline|Total|Total of all reporting groups
11256331|NCT02598076|FG000|Participant Flow|Control|"Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256332|NCT02598076|FG001|Participant Flow|Motivational Interviewing|"Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.~Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.~motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256333|NCT02598076|OG000|Outcome|Control|"Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256334|NCT02598076|OG001|Outcome|Motivational Interviewing|"Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.~Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.~motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256335|NCT02598076|EG000|Reported Event|Control|"Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11286556|NCT02889796|EG004|Reported Event|Placebo to Filgotinib 100 mg|Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
10847280|NCT00282568|OG000|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
11256336|NCT02598076|EG001|Reported Event|Motivational Interviewing|"Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.~Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.~motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.~standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES"
11256337|NCT02598089|BG000|Baseline|Trivalent Seasonal Influenza Vaccine|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256338|NCT02598089|BG001|Baseline|Placebo|0.5 mL of Phosphate Buffered Saline
11256339|NCT02598089|BG002|Baseline|Total|Total of all reporting groups
11256340|NCT02598089|FG000|Participant Flow|Trivalent Seasonal Influenza Vaccine|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1 & H3N2
11256341|NCT02598089|FG001|Participant Flow|Placebo|0.5 mL of Phosphate Buffered Saline
11256342|NCT02598089|OG000|Outcome|Vaccine Group|0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256343|NCT02598089|OG001|Outcome|Placebo Group|0.5 mL of phosphate buffered saline
11256344|NCT02598089|OG000|Outcome|Vaccine Group|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256345|NCT02598089|OG000|Outcome|Vaccine Group|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of each of 3 strains: B, H1N1, & H3N2
11256346|NCT02598089|OG000|Outcome|Vaccine Group|0.5 mL of seasonal influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256347|NCT02598089|OG001|Outcome|Placebo Group|0.5 mL of Phosphate Buffered Saline
11256348|NCT02598089|OG000|Outcome|Trivalent Seasonal Influenza Vaccine|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256349|NCT02598089|OG001|Outcome|Placebo|"0.5 mL of Phosphate Buffered Saline~Placebo Comparator: Placebo (PBS)"
11256350|NCT02598089|OG001|Outcome|Placebo|0.5 mL of Phosphate Buffered Saline
11256351|NCT02598089|EG000|Reported Event|Trivalent Seasonal Influenza Vaccine|0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2
11256352|NCT02598089|EG001|Reported Event|Placebo|0.5 mL of Phosphate Buffered Saline
11256353|NCT02598128|BG000|Baseline|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
11256354|NCT02598128|FG000|Participant Flow|Period A: Clinical Treatment Practice (Days -7 to -1)|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
11256355|NCT02598128|FG001|Participant Flow|Crossover Period B: Placebo Then RELiZORB|Eligible subjects were randomized to Placebo then RELiZORB.
11256356|NCT02598128|FG002|Participant Flow|Crossover Period B: RELiZORB Then Placebo|Eligible subjects were randomized to RELiZORB then Placebo.
11256357|NCT02598128|FG003|Participant Flow|Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)|Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
11256358|NCT02598128|OG000|Outcome|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
11256359|NCT02598128|OG001|Outcome|Crossover Period B: Placebo|Non-gastrointestinal adverse events during administration.
11256360|NCT02598128|OG002|Outcome|Crossover Period B: RELiZORB|Non-gastrointestinal adverse events during administration.
11256361|NCT02598128|OG003|Outcome|Clinical Treatment Practice + RELiZORB: Period C: Days 12-20|Non-gastrointestinal adverse events during CTP+RELiZORB administration.
11256362|NCT02598128|OG000|Outcome|RELiZORB|Subjects receiving RELiZORB at any time in the study.
11256363|NCT02598128|OG001|Outcome|Control|Subjects receiving placebo at any time in the study.
11256364|NCT02598128|OG000|Outcome|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
11256365|NCT02598128|EG000|Reported Event|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
11256366|NCT02598128|EG001|Reported Event|Double-Blind Crossover: Period B: Days 1 to 11|Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10.
11256367|NCT02598128|EG002|Reported Event|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
11256368|NCT02598193|BG000|Baseline|Pirfenidone+Nintedanib|Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
11256369|NCT02598193|FG000|Participant Flow|Pirfenidone+Nintedanib|Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
11256370|NCT02598193|OG000|Outcome|Pirfenidone+Nintedanib|Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
11256371|NCT02598193|EG000|Reported Event|Pirfenidone+Nintedanib|Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
11256372|NCT02598297|BG000|Baseline|Ruxolitinib (INC424)|Two tablets of ruxolitinib 5 mg were administered orally twice per day
11256373|NCT02598297|BG001|Baseline|Ruxolitinib Placebo|Two tablets of 5mg placebo were administered orally twice per day
11256374|NCT02598297|BG002|Baseline|Total|Total of all reporting groups
11256375|NCT02598297|FG000|Participant Flow|Ruxolitinib (INC424)|Two tablets of ruxolitinib 5 mg were administered orally twice per day
11256376|NCT02598297|FG001|Participant Flow|Ruxolitinib Placebo|Two tablets of 5mg placebo were administered orally twice per day
11256377|NCT02598297|OG000|Outcome|Ruxolitinib (INC424)|Two tablets of ruxolitinib 5 mg were administered orally twice per day
11256378|NCT02598297|OG001|Outcome|Ruxolitinib Placebo|Two tablets of 5mg placebo were administered orally twice per day
11256379|NCT02598297|EG000|Reported Event|Ruxolitinib (INC424)|Two tablets of ruxolitinib 5 mg were administered orally twice per day
11256380|NCT02598297|EG001|Reported Event|Ruxolitinib Placebo|Two tablets of 5mg placebo were administered orally twice per day
11256381|NCT02598934|BG000|Baseline|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
11256382|NCT02598934|BG001|Baseline|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
11256383|NCT02598934|BG002|Baseline|Total|Total of all reporting groups
11256384|NCT02598934|FG000|Participant Flow|Ibandronate (Consult Group)|Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
11256385|NCT02598934|FG001|Participant Flow|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
11256386|NCT02598934|OG000|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
11256387|NCT02598934|OG000|Outcome|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
11256388|NCT02598934|OG001|Outcome|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
11256389|NCT02598934|EG000|Reported Event|Ibandronate (All Participants)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
11256390|NCT02599129|BG000|Baseline|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
11256391|NCT02599129|BG001|Baseline|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
11256392|NCT02599129|BG002|Baseline|Total|Total of all reporting groups
11256393|NCT02599129|FG000|Participant Flow|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
11256394|NCT02599129|FG001|Participant Flow|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
11256395|NCT02599129|OG000|Outcome|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
11256396|NCT02599129|OG001|Outcome|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
11256397|NCT02599129|EG000|Reported Event|Secukinumab|Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
11256398|NCT02599129|EG001|Reported Event|Placebo|Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
11256399|NCT02599194|BG000|Baseline|18F-FSPG and 18F-FDG Intragroup Comparision|"Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.~18F-FSPG: Administered intravenously (IV)~18F-FDG: Administered intravenously (IV)"
11256400|NCT02599194|FG000|Participant Flow|18F-FSPG and 18F-FDG Intragroup Comparision|"Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.~18F-FSPG: Administered intravenously (IV)~18F-FDG: Administered intravenously (IV)"
11256401|NCT02599194|OG000|Outcome|18F-FSPG and 18F-FDG Intragroup Comparision|"Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.~18F-FSPG: Administered intravenously (IV)~18F-FDG: Administered intravenously (IV)"
11256402|NCT02599194|OG000|Outcome|Difference in Lesion Size as Detected by 18F-FSPG|"Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes.~18F-FSPG: Administered intravenously (IV)"
11256403|NCT02599194|OG001|Outcome|Difference in Lesion Size as Detected by 18F-FDG|"Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes.~18F-FDG: Administered intravenously (IV)"
11256404|NCT02599194|EG000|Reported Event|18F-FSPG and 18F-FDG Intragroup Comparision|"Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.~18F-FSPG: Administered intravenously (IV)~18F-FDG: Administered intravenously (IV)"
11256405|NCT02599402|BG000|Baseline|Nivolumab + Ipilimumab Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months"
11256406|NCT02599402|FG000|Participant Flow|Nivolumab + Ipilimumab Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months"
11256407|NCT02599402|OG000|Outcome|Nivolumab + Ipilimumab Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months"
11256408|NCT02599402|OG001|Outcome|Nivolumab + Ipilimumab ECOG PS0-1|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup"
11256409|NCT02599402|OG002|Outcome|Nivolumab + Ipilimumab ECOG PS2|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup"
11256410|NCT02599402|OG003|Outcome|Nivolumab + Ipilimumab Brain Metastasis|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Brain Metastasis subgroup"
11256411|NCT02599402|OG004|Outcome|Nivolumab + Ipilimumab Mucosal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Mucosal"
11256412|NCT02599402|OG005|Outcome|Nivolumab + Ipilimumab Ocular/Uveal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Ocular/Uveal"
11256413|NCT02599402|OG006|Outcome|Nivolumab + Ipilimumab Cutaneous|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Cutaneous"
11256414|NCT02599402|OG007|Outcome|Nivolumab + Ipilimumab Acral|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Acral"
11256415|NCT02599402|OG008|Outcome|Nivolumab + Ipilimumab Other|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Other"
11256416|NCT02599402|OG000|Outcome|Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256417|NCT02599402|OG001|Outcome|ECOG PS0-1|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256418|NCT02599402|OG002|Outcome|ECOG PS2|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256419|NCT02599402|OG003|Outcome|Brain Metastasis|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256420|NCT02599402|OG004|Outcome|Mucosal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256421|NCT02599402|OG005|Outcome|Ocular/Uveal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256422|NCT02599402|OG006|Outcome|Cutaneous|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256423|NCT02599402|OG007|Outcome|Acral|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256424|NCT02599402|OG008|Outcome|Other|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256425|NCT02599402|OG000|Outcome|Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W"
11256426|NCT02599402|EG000|Reported Event|Nivolumab + Ipilimumab Total|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months"
11256427|NCT02599402|EG001|Reported Event|Nivolumab + Ipilimumab ECOG PS0-1|"Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup"
11256428|NCT02599402|EG002|Reported Event|Nivolumab + Ipilimumab ECOG PS2|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup"
11256429|NCT02599402|EG003|Reported Event|Nivolumab + Ipilimumab Brain Metastasis|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Brain Metastasis subgroup"
11256430|NCT02599402|EG004|Reported Event|Nivolumab + Ipilimumab Mucosal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Mucosal"
11256431|NCT02599402|EG005|Reported Event|Nivolumab + Ipilimumab Ocular/Uveal|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Ocular/Uveal"
11256432|NCT02599402|EG006|Reported Event|Nivolumab + Ipilimumab Cutaneous|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Cutaneous"
11256433|NCT02599402|EG007|Reported Event|Nivolumab + Ipilimumab Acral|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Acral"
11256434|NCT02599402|EG008|Reported Event|Nivolumab + Ipilimumab Other|"Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months~Then~Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months~Participants were grouped in to Disease Subtype subgroup Other"
11256435|NCT02599441|BG000|Baseline|Ankle Fracture Cases|9 ankle fractures included in the study
11256436|NCT02599441|FG000|Participant Flow|Ankle Fracture Cases|9 patients with SER ankle fractures
11256437|NCT02599441|OG000|Outcome|Ankle Fracture Cases|9 ankle fractures included in the study
11256438|NCT02599441|EG000|Reported Event|Ankle Fracture Cases|9 ankle fractures included in the study
11256439|NCT02599649|BG000|Baseline|Low or Intermediate-1 MDS Group - Lirilumab|"Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks."
11256440|NCT02599649|BG001|Baseline|Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab|"Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle."
11256441|NCT02599649|BG002|Baseline|High Risk MDS Group - Azacitidine + Lirilumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256442|NCT02599649|BG003|Baseline|High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256443|NCT02599649|BG004|Baseline|Total|Total of all reporting groups
11256444|NCT02599649|FG000|Participant Flow|Low or Intermediate-1 MDS Group - Lirilumab|"Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks."
11256445|NCT02599649|FG001|Participant Flow|Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab|"Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle."
11256446|NCT02599649|FG002|Participant Flow|High Risk MDS Group - Azacitidine + Lirilumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256447|NCT02599649|FG003|Participant Flow|High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256448|NCT02599649|OG000|Outcome|Low or Intermediate-1 MDS Group - Lirilumab|"Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks."
11256449|NCT02599649|OG001|Outcome|Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab|"Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle."
11256450|NCT02599649|OG002|Outcome|High Risk MDS Group - Azacitidine + Lirilumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256451|NCT02599649|OG003|Outcome|High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256452|NCT02599649|EG000|Reported Event|Low or Intermediate-1 MDS Group - Lirilumab|"Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks."
11256453|NCT02599649|EG001|Reported Event|Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab|"Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle."
11256454|NCT02599649|EG002|Reported Event|High Risk MDS Group - Azacitidine + Lirilumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256455|NCT02599649|EG003|Reported Event|High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab|"Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.~Lirilumab: 3 mg/kg by vein every 4 weeks.~Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.~Azacitidine: 75 mg/m^2 by vein for 7 days of a 28 day cycle."
11256456|NCT02599688|BG000|Baseline|Post Treatment Follow-up|Post treatment follow-up
11256457|NCT02599688|FG000|Participant Flow|Post Treatment Follow-up|Post treatment follow-up
11256458|NCT02599688|OG000|Outcome|Post Treatment Follow-up|Post treatment follow-up
11256459|NCT02599688|EG000|Reported Event|Post Treatment Follow-up|Post treatment follow-up
11256460|NCT02599766|BG000|Baseline|AAT and Control Intervention|"Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal~Control intervention: standard physiotherapy, speech therapy and occupational therapy"
11256461|NCT02599766|FG000|Participant Flow|AAT and Control Intervention|"Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. Standard therapy that is done in the presence and with integrating an animal.~Duration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week~Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week"
11256462|NCT02599766|OG000|Outcome|Animal Assisted Therapy|"Standard therapy that is done in the presence and with integrating an animal.~animal assisted therapy: physiotherapy, speech therapy and occupational therapy in the presence of an animal"
11256463|NCT02599766|OG001|Outcome|Standard Therapy|"Standard therapy without the presence of an animal.~standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy"
11256464|NCT02599766|OG000|Outcome|Animal Assisted Therapy|"Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. Standard therapy that is done in the presence and with integrating an animal.~Duration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week"
11256465|NCT02599766|OG001|Outcome|Control Intervention|Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week
11256466|NCT02599766|EG000|Reported Event|Animal Assisted Therapy|"Standard therapy that is done in the presence and with integrating an animal.~animal assisted therapy: physiotherapy, speech therapy and occupational therapy in the presence of an animal"
11256467|NCT02599766|EG001|Reported Event|Standard Therapy|"Standard therapy without the presence of an animal.~standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy"
11256468|NCT02599961|BG000|Baseline|UX007 (Triheptanoin)|UX007 dosing was targeted and/or maintained at 35% of total daily caloric intake.
11256469|NCT02599961|FG000|Participant Flow|UX007 (Triheptanoin)|UX007 dosing was targeted and/or maintained at 35% of total daily caloric intake.
11256470|NCT02599961|OG000|Outcome|UX007 (Triheptanoin)|UX007 dosing was targeted and/or maintained at 35% of total daily caloric intake.
11256471|NCT02599961|EG000|Reported Event|UX007 (Triheptanoin)|UX007 dosing was targeted and/or maintained at 35% of total daily caloric intake.
11256472|NCT02600325|BG000|Baseline|Treatment Arm|G/E 8 weeks
11256473|NCT02600325|FG000|Participant Flow|Grazoprevir/Elbasvir 100mg/50mg|"Grazoprevir/elbasvir single tablet regimen (100/50mg)~Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg"
11256474|NCT02600325|OG000|Outcome|Treatment Group|"Grazoprevir/elbasvir single tablet regimen (100/50mg)~Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg"
11256475|NCT02600325|EG000|Reported Event|Treatment Group|"Grazoprevir/elbasvir single tablet regimen (100/50mg)~Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg"
11256476|NCT02600351|BG000|Baseline|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
11256477|NCT02600351|BG001|Baseline|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
11256478|NCT02600351|BG002|Baseline|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256479|NCT02600351|BG003|Baseline|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
11256480|NCT02600351|BG004|Baseline|Total|Total of all reporting groups
11256481|NCT02600351|FG000|Participant Flow|LDV/SOF 12 Weeks, Without Cirrhosis|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
11256482|NCT02600351|FG001|Participant Flow|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
11256483|NCT02600351|FG002|Participant Flow|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256484|NCT02600351|FG003|Participant Flow|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
11256485|NCT02600351|OG000|Outcome|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
11256486|NCT02600351|OG001|Outcome|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
11256487|NCT02600351|OG002|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256488|NCT02600351|OG003|Outcome|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
11256489|NCT02600351|OG002|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256490|NCT02600351|OG002|Outcome|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256491|NCT02600351|EG000|Reported Event|LDV/SOF 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
11256492|NCT02600351|EG001|Reported Event|LDV/SOF + RBV 12 Weeks, Without Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
11256493|NCT02600351|EG002|Reported Event|LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis|LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
11256494|NCT02600351|EG003|Reported Event|LDV/SOF 24 Weeks, With Compensated Cirrhosis|LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
11256495|NCT02600403|BG000|Baseline|Glaucoma Subjects With Intra-ocular Pressure 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256496|NCT02600403|BG001|Baseline|Glaucoma Subjects With Intra-ocular Pressure >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256497|NCT02600403|BG002|Baseline|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256498|NCT02600403|BG003|Baseline|Total|Total of all reporting groups
11256499|NCT02600403|FG000|Participant Flow|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256500|NCT02600403|FG001|Participant Flow|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11286557|NCT02889796|EG005|Reported Event|Placebo|The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
11286558|NCT02889861|BG000|Baseline|Regimen 1|"IMCgp100 weekly dosing regimen (QW)~IMCgp100: Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3"
11286559|NCT02889861|FG000|Participant Flow|Regimen 1|IMCgp100 weekly dosing regimen (QW)
11256501|NCT02600403|FG002|Participant Flow|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256502|NCT02600403|OG000|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
11256503|NCT02600403|OG001|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
11256504|NCT02600403|OG002|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.~Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.~Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma."
11256505|NCT02600403|OG000|Outcome|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256506|NCT02600403|OG001|Outcome|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256507|NCT02600403|OG002|Outcome|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256508|NCT02600403|EG000|Reported Event|Glaucoma Subjects With IOP 22-32 mmHg|"Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11286560|NCT02889861|OG000|Outcome|Regimen 1|IMCgp100 weekly dosing regimen (QW)
11286561|NCT02889861|OG000|Outcome|Participant 4001001 Regimen 1|IMCgp100 weekly dosing regimen (QW)
11286562|NCT02889861|OG001|Outcome|Participant 4002001 Regimen 1|MCgp100 weekly dosing regimen (QW)
11286563|NCT02889861|OG002|Outcome|Participant 4003001 Regimen 1|MCgp100 weekly dosing regimen (QW)
11286564|NCT02889861|OG001|Outcome|Participant 4002001 Regimen 1|IMCgp100 weekly dosing regimen (QW)
11286565|NCT02889861|OG002|Outcome|Participant 4003001 Regimen 1|IMCgp100 weekly dosing regimen (QW)
11256509|NCT02600403|EG001|Reported Event|Glaucoma Subjects With IOP >32 mmHg|"Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256510|NCT02600403|EG002|Reported Event|Control Glaucoma Subjects|"Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).~Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.~Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.~Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.~Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma."
11256511|NCT02600559|BG000|Baseline|6 mg OTO-201|6 mg ciprofloxacin: single administration
11256512|NCT02600559|FG000|Participant Flow|6 mg OTO-201|6 mg ciprofloxacin: single administration
11256513|NCT02600559|OG000|Outcome|6 mg OTO-201|6 mg ciprofloxacin: single administration
11256514|NCT02600559|EG000|Reported Event|6 mg OTO-201|6 mg ciprofloxacin: single administration
11256515|NCT02600611|BG000|Baseline|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~iclaprim: Experimental treatment"
11256516|NCT02600611|BG001|Baseline|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~vancomycin: Active comparator"
11256517|NCT02600611|BG002|Baseline|Total|Total of all reporting groups
11256518|NCT02600611|FG000|Participant Flow|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~iclaprim: Experimental treatment"
11256519|NCT02600611|FG001|Participant Flow|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~vancomycin: Active comparator"
11256520|NCT02600611|OG000|Outcome|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~iclaprim: Experimental treatment"
11256521|NCT02600611|OG001|Outcome|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~vancomycin: Active comparator"
11256522|NCT02600611|EG000|Reported Event|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~iclaprim: Experimental treatment"
11256523|NCT02600611|EG001|Reported Event|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~vancomycin: Active comparator"
11256524|NCT02600637|BG000|Baseline|MBSR|"Mindfulness-based Stress Reduction program~MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms."
11256525|NCT02600637|BG001|Baseline|Education|"Educational group program~Brain Health class: An 8-week course on brain health will be administered to participants as an active control group."
11256526|NCT02600637|BG002|Baseline|Total|Total of all reporting groups
11256527|NCT02600637|FG000|Participant Flow|MBSR|"Mindfulness-based Stress Reduction program~MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms."
11256528|NCT02600637|FG001|Participant Flow|Education|"Educational group program~Brain Health class: An 8-week course on brain health will be administered to participants as an active control group."
11256529|NCT02600637|OG000|Outcome|MBSR|"Mindfulness-based Stress Reduction program~MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms."
11256530|NCT02600637|OG001|Outcome|Education|"Educational group program~Brain Health class: An 8-week course on brain health will be administered to participants as an active control group."
11256531|NCT02600637|EG000|Reported Event|MBSR|"Mindfulness-based Stress Reduction program~MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms."
11256532|NCT02600637|EG001|Reported Event|Education|"Educational group program~Brain Health class: An 8-week course on brain health will be administered to participants as an active control group."
11256533|NCT02600715|BG000|Baseline|Active B&O Suppository of Belladonna|"Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg"
11256534|NCT02600715|BG001|Baseline|Placebo Suppository|"Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~Placebo: matching placebo to B&O suppository"
11256535|NCT02600715|BG002|Baseline|Total|Total of all reporting groups
11256536|NCT02600715|FG000|Participant Flow|Active Belladonna & Opiate (B&O) Suppository|"Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg"
11256537|NCT02600715|FG001|Participant Flow|Placebo Suppository|"Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~Placebo: matching placebo to B&O suppository"
11286566|NCT02889861|EG000|Reported Event|Regimen 1|IMCgp100 weekly dosing regimen (QW)
11256538|NCT02600715|OG000|Outcome|Active B&O Suppository of Belladonna|"Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg"
11256539|NCT02600715|OG001|Outcome|Placebo Suppository|"Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~Placebo: matching placebo to B&O suppository"
11256540|NCT02600715|OG002|Outcome|Total|26 participants
11256541|NCT02600715|OG002|Outcome|Total|25 participants
11256542|NCT02600715|EG000|Reported Event|Active B&O Suppository of Belladonna|"Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.~Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg"
11256543|NCT02600715|EG001|Reported Event|Placebo Suppository|"Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.~Onabotulinumtoxin A (BoNT)~Placebo: matching placebo to B&O suppository"
11256544|NCT02600715|EG002|Reported Event|Total|25 participants completed the two-week follow-up visit
11286567|NCT02890303|BG000|Baseline|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
11286568|NCT02890303|FG000|Participant Flow|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
11286569|NCT02890303|OG000|Outcome|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
11286570|NCT02890303|EG000|Reported Event|Zepto Capsulotomy|"This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)~Zepto System: Anterior Capsulotomy using the Zepto System."
11286571|NCT02890381|BG000|Baseline|RSV LID cp ΔM2-2 Vaccine|"Participants received a single dose of the RSV LID cp ΔM2-2 vaccine at study entry (Day 0).~RSV LID cp ΔM2-2 Vaccine: 10^5 plaque-forming units (PFUs); administered as nose drops"
11286572|NCT02890381|BG001|Baseline|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Administered as nose drops"
11286573|NCT02890381|BG002|Baseline|Total|Total of all reporting groups
11286574|NCT02890381|FG000|Participant Flow|RSV LID cp ΔM2-2 Vaccine|"Participants received a single dose of the RSV LID cp ΔM2-2 vaccine at study entry (Day 0).~RSV LID cp ΔM2-2 Vaccine: 10^5 plaque-forming units (PFUs); administered as nose drops"
11286575|NCT02890381|FG001|Participant Flow|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Administered as nose drops"
11286576|NCT02890381|OG000|Outcome|RSV LID cp ΔM2-2 Vaccine|"Participants received a single dose of the RSV LID cp ΔM2-2 vaccine at study entry (Day 0).~RSV LID cp ΔM2-2 Vaccine: 10^5 plaque-forming units (PFUs); administered as nose drops"
11286577|NCT02890381|OG001|Outcome|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Administered as nose drops"
11286578|NCT02890381|EG000|Reported Event|Vaccine|"Participants received a single dose of the RSV LID cp ΔM2-2 vaccine at study entry (Day 0).~RSV LID cp ΔM2-2 Vaccine: 10^5 plaque-forming units (PFUs); administered as nose drops"
11286579|NCT02890381|EG001|Reported Event|Placebo|Participants received a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops
11286580|NCT02890992|BG000|Baseline|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286581|NCT02890992|BG001|Baseline|Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286582|NCT02890992|BG002|Baseline|Cohort 2 - Alirocumab 40 mg Q2W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11256545|NCT02600767|BG000|Baseline|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
11256546|NCT02600767|FG000|Participant Flow|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
11256547|NCT02600767|OG000|Outcome|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
11256548|NCT02600767|EG000|Reported Event|Artemether-Lumefantrine|"Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.~Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria."
11256549|NCT02600819|BG000|Baseline|E/C/F/TAF (GEN Phase)|Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
11256550|NCT02600819|FG000|Participant Flow|E/C/F/TAF (GEN Phase)|Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
11256551|NCT02600819|FG001|Participant Flow|E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)|At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
11256552|NCT02600819|OG000|Outcome|E/C/F/TAF (GEN Phase)|Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
11256553|NCT02600819|OG000|Outcome|E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)|At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
11256554|NCT02600819|EG000|Reported Event|E/C/F/TAF (GEN Phase)|Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
11256555|NCT02600819|EG001|Reported Event|E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)|At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
11256556|NCT02600845|BG000|Baseline|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
11256557|NCT02600845|FG000|Participant Flow|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
11256558|NCT02600845|OG000|Outcome|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
11256559|NCT02600845|EG000|Reported Event|ACCU-CHEK|All participants utilized ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
11286583|NCT02890992|BG003|Baseline|Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130."
11337402|NCT03583606|BG002|Baseline|ChAd3-EBO-Z + MVA- BN-Filo|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).~MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10^8 Infectious Units (IU)."
11256560|NCT02600871|BG000|Baseline|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine applied with a Q-tip to the walls and floor of the abscess cavity. Contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
11256561|NCT02600871|BG001|Baseline|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and have the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered the wound with 4x4 gauze and washed hands with soap and water for 1 minute."
11256562|NCT02600871|BG002|Baseline|Total|Total of all reporting groups
11256563|NCT02600871|FG000|Participant Flow|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine were applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and cover ed the wound with 4x4 gauze."
11256564|NCT02600871|FG001|Participant Flow|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
11256565|NCT02600871|OG000|Outcome|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
11256566|NCT02600871|OG001|Outcome|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned within 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They then covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
11256567|NCT02600871|OG001|Outcome|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
11256568|NCT02600871|EG000|Reported Event|Provodine|"Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.~Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.~Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze."
11256569|NCT02600871|EG001|Reported Event|Standard Care|"Standard care patients had standard care including incision and drainage.~Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.~Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute."
11256570|NCT02601001|BG000|Baseline|Placebo|Participants received placebo tablets twice a day (BID) in dosing period 1 (days 1 to 8) and in dosing period 2 (days 20 to 27).
11256571|NCT02601001|BG001|Baseline|Group A: Omecamtiv Mecarbil 25 mg / 37.5 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg or 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 predose omecamtiv mecarbil plasma concentration (Cpredose): If day 8 Cpredose was < 200 ng/mL, participants received 37.5 mg BID; if day 8 Cpredose was ≥ 200 ng/mL participants continued to receive 25 mg BID.
11256572|NCT02601001|BG002|Baseline|Group B: Omecamtiv Mecarbil 25 mg / 50 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg or 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 predose omecamtiv mecarbil plasma concentration (Cpredose): If day 8 Cpredose was < 200 ng/mL, participants received 50 mg BID; if day 8 Cpredose was ≥ 200 ng/mL participants continued to receive 25 mg BID.
11256573|NCT02601001|BG003|Baseline|Total|Total of all reporting groups
11337403|NCT03583606|BG003|Baseline|Total|Total of all reporting groups
11256574|NCT02601001|FG000|Participant Flow|Placebo|Participants received placebo tablets twice a day (BID) in dosing period 1 (days 1 to 8) and in dosing period 2 (days 20 to 27).
11256575|NCT02601001|FG001|Participant Flow|Period 1 Group A: Omecamtiv Mecarbil 25 mg|Participants received omecamtiv mecarbil (OM) 25 mg BID in dosing period 1 (days 1 to 8).
11256576|NCT02601001|FG002|Participant Flow|Period 1 Group B: Omecamtiv Mecarbil 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8).
11256577|NCT02601001|FG003|Participant Flow|Period 2 Group A: Omecamtiv Mecarbil 25 mg|Participants who received omecamtiv mecarbil 25 mg BID in dosing period 1 then received omecamtiv mecarbil 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 predose omecamtiv mecarbil plasma concentration (Cpredose).
11256578|NCT02601001|FG004|Participant Flow|Period 2 Group A: Omecamtiv Mecarbil 37.5 mg|Participants who received omecamtiv mecarbil 25 mg BID in dosing period 1 then received omecamtiv mecarbil 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256579|NCT02601001|FG005|Participant Flow|Period 2 Group B: Omecamtiv Mecarbil 25 mg|Participants who received omecamtiv mecarbil 25 mg BID in dosing period 1 then received omecamtiv mecarbil 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256580|NCT02601001|FG006|Participant Flow|Period 2 Group B: Omecamtiv Mecarbil 50 mg|Participants who received omecamtiv mecarbil 25 mg BID in dosing period 1 then received omecamtiv mecarbil 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256581|NCT02601001|OG000|Outcome|Group A: Omecamtiv Mecarbil 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8).
11256582|NCT02601001|OG001|Outcome|Group B: Omecamtiv Mecarbil 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8).
11256583|NCT02601001|OG000|Outcome|Group A: Omecamtiv Mecarbil 25 mg / 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256584|NCT02601001|OG001|Outcome|Group A: Omecamtiv Mecarbil 25 mg / 37.5 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256585|NCT02601001|OG002|Outcome|Group B: Omecamtiv Mecarbil 25 mg / 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256586|NCT02601001|OG003|Outcome|Group B: Omecamtiv Mecarbil 25 mg / 50 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256587|NCT02601001|OG000|Outcome|Placebo|Participants received placebo tablets twice a day (BID) in dosing period 1 (days 1 to 8) and in dosing period 2 (days 20 to 27).
11256588|NCT02601001|OG001|Outcome|Group A: Omecamtiv Mecarbil 25 mg / 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256589|NCT02601001|OG002|Outcome|Group A: Omecamtiv Mecarbil 25 mg / 37.5 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256590|NCT02601001|OG003|Outcome|Group B: Omecamtiv Mecarbil 25 mg / 25 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256591|NCT02601001|OG004|Outcome|Group B: Omecamtiv Mecarbil 25 mg / 50 mg|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256592|NCT02601001|EG000|Reported Event|Period 1: Placebo|Participants received placebo tablets twice a day (BID) in dosing period 1 (days 1 to 8).
11256593|NCT02601001|EG001|Reported Event|Period 1 Group A: OM 25 mg BID|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8).
11256594|NCT02601001|EG002|Reported Event|Period 1 Group B: OM 25 mg BID|Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8).
11256595|NCT02601001|EG003|Reported Event|Period 2: Placebo|Participants received placebo tablets BID in dosing period 2 (days 20 to 27).
11256596|NCT02601001|EG004|Reported Event|Period 2 Group A: OM 25 mg BID|Participants received omecamtiv mecarbil 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256597|NCT02601001|EG005|Reported Event|Period 2 Group A: OM 37.5 mg BID|Participants received omecamtiv mecarbil 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256598|NCT02601001|EG006|Reported Event|Period 2 Group B: OM 25 mg BID|Participants received omecamtiv mecarbil 25 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256599|NCT02601001|EG007|Reported Event|Period 2 Group B: OM 50 mg BID|Participants received omecamtiv mecarbil 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 omecamtiv mecarbil Cpredose.
11256600|NCT02601027|BG000|Baseline|0.125% Bupivacaine|"0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256601|NCT02601027|BG001|Baseline|Placebo|"Saline infusion (sham) via transversus abdominis plane (TAP) catheter.~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256602|NCT02601027|BG002|Baseline|Total|Total of all reporting groups
11256603|NCT02601027|FG000|Participant Flow|0.125% Bupivacaine|"0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256604|NCT02601027|FG001|Participant Flow|Placebo|"Saline infusion (sham) for transversus abdominis plane (TAP) catheter.~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256605|NCT02601027|OG000|Outcome|0.125% Bupivacaine|"0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256606|NCT02601027|OG001|Outcome|Placebo|"Saline infusion (sham) for transversus abdominis plane (TAP) catheter.~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256607|NCT02601027|EG000|Reported Event|0.125% Bupivacaine|"0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256608|NCT02601027|EG001|Reported Event|Placebo|"Saline infusion (sham) for transversus abdominis plane (TAP) catheter.~Transversus Abdominis Plane (TAP) block~Nimbus Infusion Pump IV Administration~Bupivacaine infusion~Acetominophen~Hydromorphone~Oxycodone~Ondansetron"
11256609|NCT02601105|BG000|Baseline|All Study Participants|"Placebo Vehicle Cream: Lipoderm Cream Alone~Lipoderm® base served as the placebo vehicle control to be applied every night to demarcated 10 x 10 cm area containing stretch marks on randomly assigned side of abdomen for 12 weeks.~Centella Asiatica: 1% Centella Asiatica in Lipoderm Cream~An alcoholic extract of CA (verified by HPLC) mixed into a Lipoderm® base served as the treatment cream to be applied every night to demarcated 10 x 10 cm area containing stretch marks on the opposite side of the abdomen for 12 weeks."
11256610|NCT02601105|FG000|Participant Flow|All Study Participants|"Placebo Vehicle Cream: Lipoderm Cream Alone Lipoderm® base served as the placebo vehicle control to be applied every night to demarcated 10 x 10 cm area containing stretch marks on randomly assigned side of abdomen for 12 weeks.~Centella Asiatica: 1% Centella Asiatica in Lipoderm Cream An alcoholic extract of CA (verified by HPLC) mixed into a Lipoderm® base served as the treatment cream to be applied every night to demarcated 10 x 10 cm area containing stretch marks on the opposite side of the abdomen for 12 weeks."
11256611|NCT02601105|OG000|Outcome|Placebo Vehicle Cream|"Lipoderm® base served as the placebo vehicle control to be applied every night to demarcated 10 x 10 cm area containing stretch marks on randomly assigned side of abdomen for 12 weeks.~Placebo Vehicle Cream: Lipoderm cream"
11256612|NCT02601105|OG001|Outcome|Centella Asiatica|"An alcoholic extract of CA (verified by HPLC) mixed into a Lipoderm® base served as the treatment cream to be applied every night to demarcated 10 x 10 cm area containing stretch marks on the opposite side of the abdomen for 12 weeks.~Centella Asiatica: 1% Centella Asiatica in lipoderm"
11256613|NCT02601105|EG000|Reported Event|Placebo Vehicle Cream|"Lipoderm® base served as the placebo vehicle control to be applied every night to demarcated 10 x 10 cm area containing stretch marks on randomly assigned side of abdomen for 12 weeks.~Placebo Vehicle Cream: Lipoderm cream"
11256614|NCT02601105|EG001|Reported Event|Centella Asiatica|"An alcoholic extract of CA (verified by HPLC) mixed into a Lipoderm® base served as the treatment cream to be applied every night to demarcated 10 x 10 cm area containing stretch marks on the opposite side of the abdomen for 12 weeks.~Centella Asiatica: 1% Centella Asiatica in lipoderm"
11256615|NCT02601170|BG000|Baseline|PRP Group|"single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)~Platelet-Rich Plasma Intra-Articular Injection"
11256616|NCT02601170|BG001|Baseline|HA Group|"five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).~Hyaluronic Acid Viscosupplementation"
11256617|NCT02601170|BG002|Baseline|Total|Total of all reporting groups
11256618|NCT02601170|FG000|Participant Flow|PRP Group|"single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)~Platelet-Rich Plasma Intra-Articular Injection"
11256619|NCT02601170|FG001|Participant Flow|HA Group|"five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).~Hyaluronic Acid Viscosupplementation"
11256620|NCT02601170|OG000|Outcome|PRP Group|"single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)~Platelet-Rich Plasma Intra-Articular Injection"
11256621|NCT02601170|OG001|Outcome|HA Group|"five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).~Hyaluronic Acid Viscosupplementation"
11256622|NCT02601170|EG000|Reported Event|PRP Group|"single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)~Platelet-Rich Plasma Intra-Articular Injection"
11256623|NCT02601170|EG001|Reported Event|HA Group|"five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).~Hyaluronic Acid Viscosupplementation"
11256624|NCT02601300|BG000|Baseline|Mongersen (Weeks 0-52)|Participants received oral mongersen 160 mg tablets daily for 8 weeks during the induction phase, followed by 160 mg tablets daily on an alternating dosing schedule for 4 weeks, followed by a 4 week break, (4 weeks on investigational product (IP), followed by 4 weeks off) for an additional 44 weeks during the extension phase, weeks 8 through 52). Participants who did not achieve at least a 20% decrease in a partial Mayo score (PMS) from baseline at Week 12 were discontinued from the study.
11256625|NCT02601300|FG000|Participant Flow|Mongersen (Weeks 0-52)|Participants received oral mongersen 160 mg tablets daily for 8 weeks during the induction phase, followed by 160 mg tablets daily on an alternating dosing schedule for 4 weeks, followed by a 4 week break, (4 weeks on investigational product (IP), followed by 4 weeks off) for an additional 44 weeks during the extension phase, weeks 8 through 52). Participants who did not achieve at least a 20% decrease in a partial Mayo score (PMS) from baseline at Week 12 were discontinued from the study.
11256626|NCT02601300|OG000|Outcome|Mongersen (Weeks 0-52)|Participants received oral mongersen 160 mg tablets daily for 8 weeks during the induction phase, followed by 160 mg tablets daily on an alternating dosing schedule for 4 weeks, followed by a 4 week break, (4 weeks on investigational product (IP), followed by 4 weeks off) for an additional 44 weeks during the extension phase, weeks 8 through 52). Participants who did not achieve at least a 20% decrease in a partial Mayo score (PMS) from baseline at Week 12 were discontinued from the study.
11256627|NCT02601300|OG000|Outcome|Mongersen Total Mongersen Exposure Period|Participants who received oral mongersen 160 mg tablets during the induction phase and the extension phase, with dosing starting on the first mongersen dose of the induction phase and ended at the last follow-up date up to 28 days after the last mongersen dose (either in the induction or the extension phase)
11256628|NCT02601300|EG000|Reported Event|Mongersen (Induction Phase: Weeks 0-8)|Participants received oral mongersen 160 mg tablets daily for 8 weeks during the induction phase.
11256629|NCT02601300|EG001|Reported Event|Mongersen (Extension Phase: Weeks 8-52)|Participants received oral mongersen 160 mg tablets daily on an alternating dosing schedule for 4 weeks, followed by a 4 week break, (4 weeks on investigational product (IP), followed by 4 weeks off) for an additional 44 weeks during the extension phase. Participants who did not achieve at least a 20% decrease in a partial Mayo score (PMS) from baseline at Week 12 were discontinued from the study.
11256630|NCT02601469|BG000|Baseline|DSXS1503 Cohort 1|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.~DSXS: twice daily for 28 days"
11256631|NCT02601469|BG001|Baseline|DSXS1503 Cohort 2|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.~DSXS: twice daily for 28 days"
11256632|NCT02601469|BG002|Baseline|Total|Total of all reporting groups
11256633|NCT02601469|FG000|Participant Flow|DSXS1503 Cohort 1|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.~DSXS: twice daily for 28 days"
11256634|NCT02601469|FG001|Participant Flow|DSXS1503 Cohort 2|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.~DSXS: twice daily for 28 days"
11256635|NCT02601469|OG000|Outcome|DSXS1503 Cohort 1|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.~DSXS: twice daily for 28 days"
11256636|NCT02601469|OG001|Outcome|DSXS1503 Cohort 2|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.~DSXS: twice daily for 28 days"
11256637|NCT02601469|EG000|Reported Event|DSXS1503 Cohort 1|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.~DSXS: twice daily for 28 days"
11256638|NCT02601469|EG001|Reported Event|DSXS1503 Cohort 2|"Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.~DSXS: twice daily for 28 days"
11256639|NCT02601560|BG000|Baseline|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
11256640|NCT02601560|BG001|Baseline|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
11256641|NCT02601560|BG002|Baseline|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
11256642|NCT02601560|BG003|Baseline|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
11256643|NCT02601560|BG004|Baseline|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
11256644|NCT02601560|BG005|Baseline|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
11256645|NCT02601560|BG006|Baseline|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
11256646|NCT02601560|BG007|Baseline|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256647|NCT02601560|BG008|Baseline|Total|Total of all reporting groups
11256648|NCT02601560|FG000|Participant Flow|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
11256649|NCT02601560|FG001|Participant Flow|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
11256650|NCT02601560|FG002|Participant Flow|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
11256651|NCT02601560|FG003|Participant Flow|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
11256652|NCT02601560|FG004|Participant Flow|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
11256653|NCT02601560|FG005|Participant Flow|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
11256654|NCT02601560|FG006|Participant Flow|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
11256655|NCT02601560|FG007|Participant Flow|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256656|NCT02601560|OG000|Outcome|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
11256657|NCT02601560|OG001|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
11256658|NCT02601560|OG002|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
11256659|NCT02601560|OG003|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
11256660|NCT02601560|OG004|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
11256661|NCT02601560|OG005|Outcome|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
11256662|NCT02601560|OG006|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
11256663|NCT02601560|OG007|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256664|NCT02601560|OG000|Outcome|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
11256665|NCT02601560|OG001|Outcome|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
11256666|NCT02601560|OG002|Outcome|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
11256667|NCT02601560|OG003|Outcome|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
11256668|NCT02601560|OG004|Outcome|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
11256669|NCT02601560|OG005|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256670|NCT02601560|OG004|Outcome|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256671|NCT02601560|EG000|Reported Event|Placebo Intravenous (IV)|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
11256672|NCT02601560|EG001|Reported Event|MEDI6012 24 Milligram (mg) IV|Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
11256673|NCT02601560|EG002|Reported Event|MEDI6012 80 mg IV|Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
11256674|NCT02601560|EG003|Reported Event|MEDI6012 240 mg IV|Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
11256675|NCT02601560|EG004|Reported Event|MEDI6012 800 mg IV|Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
11256676|NCT02601560|EG005|Reported Event|Placebo Subcutaneous (SC)|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
11256677|NCT02601560|EG006|Reported Event|MEDI6012 80 mg SC|Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
11256678|NCT02601560|EG007|Reported Event|MEDI6012 600 mg SC|Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
11256679|NCT02601573|BG000|Baseline|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
11256680|NCT02601573|BG001|Baseline|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256681|NCT02601573|BG002|Baseline|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256682|NCT02601573|BG003|Baseline|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
11256683|NCT02601573|BG004|Baseline|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
11256684|NCT02601573|BG005|Baseline|Total|Total of all reporting groups
11256685|NCT02601573|FG000|Participant Flow|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.
11256686|NCT02601573|FG001|Participant Flow|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256687|NCT02601573|FG002|Participant Flow|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256688|NCT02601573|FG003|Participant Flow|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
11256689|NCT02601573|FG004|Participant Flow|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
11256690|NCT02601573|OG000|Outcome|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
11256691|NCT02601573|OG001|Outcome|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256692|NCT02601573|OG002|Outcome|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256693|NCT02601573|OG003|Outcome|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
11256694|NCT02601573|OG004|Outcome|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
11256695|NCT02601573|EG000|Reported Event|Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
11256696|NCT02601573|EG001|Reported Event|Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks|TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256697|NCT02601573|EG002|Reported Event|Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
11256698|NCT02601573|EG003|Reported Event|Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
11256699|NCT02601573|EG004|Reported Event|Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks|TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
11256700|NCT02601625|BG000|Baseline|Anifrolumab 300 mg SC Injections|Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256701|NCT02601625|BG001|Baseline|Anifrolumab 300 mg IV Infusion|Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1
11256702|NCT02601625|BG002|Baseline|Anifrolumab 600 mg SC Infusion|Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1
11256703|NCT02601625|BG003|Baseline|Pooled Placebo|Randomized participants received Anifrolumab matching placebo.
11256704|NCT02601625|BG004|Baseline|Total|Total of all reporting groups
11256705|NCT02601625|FG000|Participant Flow|Anifrolumab 300 mg SC Injections|Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256706|NCT02601625|FG001|Participant Flow|Anifrolumab 300 mg IV Infusion|Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1
11256707|NCT02601625|FG002|Participant Flow|Anifrolumab 600 mg SC Infusion|Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1
11256708|NCT02601625|FG003|Participant Flow|Pooled Placebo|Randomized participants received Anifrolumab matching placebo.
11256709|NCT02601625|OG000|Outcome|Anifrolumab 300 mg SC Injections|Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256710|NCT02601625|OG001|Outcome|Anifrolumab 300 mg IV Infusion|Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1
11256711|NCT02601625|OG002|Outcome|Anifrolumab 600 mg SC Infusion|Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1
11256712|NCT02601625|OG003|Outcome|Pooled Placebo|Randomized participants received Anifrolumab matching placebo.
11256713|NCT02601625|OG004|Outcome|Placebo 300 mg Anifrolumab SC|Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256714|NCT02601625|OG005|Outcome|Placebo 600 mg Anifrolumab SC|Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.
11256715|NCT02601625|OG006|Outcome|Placebo 300 mg Anifrolumab IV|Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.
11256716|NCT02601625|OG007|Outcome|All Anifrolumab Participants|Overall number of participants who received anifrolumab therapy.
11256717|NCT02601625|OG001|Outcome|Anifrolumab 600 mg SC Infusion|Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1
11256718|NCT02601625|OG002|Outcome|Placebo 300 mg Anifrolumab SC|Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256719|NCT02601625|OG003|Outcome|Placebo 600 mg Anifrolumab SC|Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.
11256720|NCT02601625|OG002|Outcome|Placebo 300mg SC Injection|Participants received 300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1.
11256721|NCT02601625|OG003|Outcome|Placebo 600 mg SC Injection|Participants received placebo 600mg
11256722|NCT02601625|OG004|Outcome|All Subjects|Overall participants.
11256723|NCT02601625|EG000|Reported Event|Anifrolumab 300 mg SC Injections|Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256724|NCT02601625|EG001|Reported Event|Anifrolumab 300 mg IV Infusion|Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1
11256725|NCT02601625|EG002|Reported Event|Placebo 300 mg Anifrolumab SC|Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.
11256726|NCT02601625|EG003|Reported Event|Placebo 300 mg IV Infusion|Participants received 300 mg single dose placebo delivered as an IV infusion over 30 minutes on Day 1.
11256727|NCT02601625|EG004|Reported Event|Placebo 600 mg Anifrolumab (SC)|Participants received 600 mg single dose placebo delivered as 4 mL SC by infusion pump on Day 1.
11256728|NCT02601625|EG005|Reported Event|Anifrolumab 600 mg SC Infusion|Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1
11256729|NCT02601625|EG006|Reported Event|Pooled Placebo|Randomized participants received Anifrolumab matching placebo.
11256730|NCT02601625|EG007|Reported Event|All Anifrolumab Subjects|Overall number of participants who received anifrolumab therapy
11256731|NCT02601820|BG000|Baseline|Chronic HCV Patients on Treatment|All 1,601 patients with chronic HCV enrolled at baseline
11256732|NCT02601820|FG000|Participant Flow|Chronic HCV Patients During and After HCV Treatment|1601 patients with chronic hepatitis C were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy.
11256733|NCT02601820|OG000|Outcome|Chronic HCV Patients on Therapy|All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
11256734|NCT02601820|OG000|Outcome|Chronic HCV Patients on Therapy|All enrolled patients with symptom data recorded at T2 or T3 during HCV treatment
11256735|NCT02601820|OG000|Outcome|Chronic HCV Patients on Therapy|All enrolled patients with HCV-PRO data available at T2 or T3 during HCV treatment
11256736|NCT02601820|OG000|Outcome|Chronic HCV Patients During and After HCV Treatment|1601 patients with chronic HCV were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy.
11256737|NCT02601820|OG000|Outcome|Patients With Baseline Mental Health Disturbance|For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
11256738|NCT02601820|OG001|Outcome|Patients Without Baseline Mental Health Disturbance|For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
11256739|NCT02601820|OG002|Outcome|Patients With Baseline Alcohol Abuse|for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
11256740|NCT02601820|OG003|Outcome|Patients Without Baseline Alcohol Abuse|for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
11256741|NCT02601820|OG004|Outcome|Patients With Baseline Substance Use|For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
11256742|NCT02601820|OG005|Outcome|Patients Without Baseline Substance Use|For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
11256743|NCT02601820|OG000|Outcome|Chronic HCV Patients Who Achieved SVR|Chronic HCV patients who achieved a sustained virologic cure (SVR) 3-months post-treatment
11256744|NCT02601820|OG001|Outcome|Chronic HCV Patients Who Did Not Achieve SVR|Chronic HCV patients who did not achieve a sustained virologic cure (SVR) 3-months post-treatment
11256745|NCT02601820|OG000|Outcome|Chronic HCV Patients Who Achieved SVR|Chronic HCV patients who achieved a sustained virologic cure (SVR) and completed PRO data one-year post-treatment (T5)
11256746|NCT02601820|OG001|Outcome|Chronic HCV Patients Who Did Not Achieve SVR|Chronic HCV patients who did not achieve a sustained virologic cure (SVR) and completed data one-year post-treatment (T5)
11256747|NCT02601820|EG000|Reported Event|Chronic HCV Patients During and After HCV Treatment|1601 patients with chronic HCV were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy.
11256748|NCT02601833|BG000|Baseline|Silver Diamine Fluoride|"This arm will receive Silver Diamine Fluoride applied to their carious lesion, at baseline and 6 months, in lieu of restoration placement, with the goal of arresting caries.~Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet."
11256749|NCT02601833|BG001|Baseline|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and the University of Michigan School of Dentistry."
11256750|NCT02601833|BG002|Baseline|Total|Total of all reporting groups
11256751|NCT02601833|FG000|Participant Flow|Silver Diamine Fluoride|"This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months.~Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet."
11256752|NCT02601833|FG001|Participant Flow|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic."
11256753|NCT02601833|OG000|Outcome|Silver Diamine Fluoride|"This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months.~Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet."
11256754|NCT02601833|OG000|Outcome|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic."
11256755|NCT02601833|OG001|Outcome|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic."
11256756|NCT02601833|OG000|Outcome|Silver Diamine Fluoride|"This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.~Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet."
11256757|NCT02601833|OG001|Outcome|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration."
11256758|NCT02601833|EG000|Reported Event|Silver Diamine Fluoride|"This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months.~Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet."
11256759|NCT02601833|EG001|Reported Event|Conventional Caries Management|"Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.~Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic."
11256760|NCT02601976|BG000|Baseline|PegInterferon Alfa-2a and Ribavirin|"PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight~Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.~Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)"
11256761|NCT02601976|FG000|Participant Flow|PegInterferon Alfa-2a and Ribavirin|"PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight~Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.~Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)"
11256762|NCT02601976|OG000|Outcome|PegInterferon Alfa-2a and Ribavirin|"PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight~Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.~Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)"
11256763|NCT02601976|EG000|Reported Event|PegInterferon Alfa-2a and Ribavirin|"PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight~Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.~Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)"
11256764|NCT02602080|BG000|Baseline|FA Patients Under Popliteal Block + Spinal + Sedation|Foot and ankle patients under popliteal block+ spinal+ sedation
11256765|NCT02602080|BG001|Baseline|TSA Patients Under Brachial Plexus Block + General (LMA)|Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
11256766|NCT02602080|BG002|Baseline|TSA Patients Under Brachial Plexus Block + Sedation|Total shoulder arthroplasty patients under brachial plexus block + sedation
11256767|NCT02602080|BG003|Baseline|Total|Total of all reporting groups
11256768|NCT02602080|FG000|Participant Flow|FA Patients Under Popliteal Block + Spinal + Sedation|Foot and ankle patients under popliteal block+ spinal+ sedation
11256769|NCT02602080|FG001|Participant Flow|TSA Patients Under Brachial Plexus Block + General (LMA)|Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
11256770|NCT02602080|FG002|Participant Flow|TSA Patients Under Brachial Plexus Block + Sedation|Total shoulder arthroplasty patients under brachial plexus block + sedation
11256771|NCT02602080|OG000|Outcome|FA Patients Under Popliteal Block + Spinal + Sedation|Foot and ankle patients under popliteal block+ spinal+ sedation
11256772|NCT02602080|OG001|Outcome|TSA Patients Under Brachial Plexus Block + General (LMA)|Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
11256773|NCT02602080|OG002|Outcome|TSA Patients Under Brachial Plexus Block + Sedation|Total shoulder arthroplasty patients under brachial plexus block + sedation
11256774|NCT02602080|EG000|Reported Event|FA Patients Under Popliteal Block + Spinal + Sedation|Foot and ankle patients under popliteal block+ spinal+ sedation
11256775|NCT02602080|EG001|Reported Event|TSA Patients Under Brachial Plexus Block + General (LMA)|Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
11256776|NCT02602080|EG002|Reported Event|TSA Patients Under Brachial Plexus Block + Sedation|Total shoulder arthroplasty patients under brachial plexus block + sedation
11256777|NCT02602223|BG000|Baseline|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
11256778|NCT02602223|FG000|Participant Flow|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
11256779|NCT02602223|OG000|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
11286584|NCT02890992|BG004|Baseline|Cohort 3 - Alirocumab 75 mg Q4W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11256780|NCT02602223|OG001|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
11256781|NCT02602223|EG000|Reported Event|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
11256782|NCT02602223|EG001|Reported Event|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
11256783|NCT02602496|BG000|Baseline|Control|"3 servings of refined grains per day.~Control: 3 servings of refined grain"
11256784|NCT02602496|BG001|Baseline|Fruits and Vegetables|"5 servings of fruits and vegetable per day.~Fruits and Vegetables: 5 servings of fruits or vegetables"
11256785|NCT02602496|BG002|Baseline|Whole Grain|"3 servings of whole grains per day.~Whole Grain: 3 servings of whole grain"
11256786|NCT02602496|BG003|Baseline|Total|Total of all reporting groups
11256787|NCT02602496|FG000|Participant Flow|Control|"3 servings of refined grains per day.~Control: 3 servings of refined grain"
11256788|NCT02602496|FG001|Participant Flow|Fruits and Vegetables|"5 servings of fruits and vegetable per day.~Fruits and Vegetables: 5 servings of fruits or vegetables"
11256789|NCT02602496|FG002|Participant Flow|Whole Grain|"3 servings of whole grains per day.~Whole Grain: 3 servings of whole grain"
11256790|NCT02602496|OG000|Outcome|Control|"3 servings of refined grains per day.~Control: 3 servings of refined grain"
11256791|NCT02602496|OG001|Outcome|Fruits and Vegetables|"5 servings of fruits and vegetable per day.~Fruits and Vegetables: 5 servings of fruits or vegetables"
11256792|NCT02602496|OG002|Outcome|Whole Grain|"3 servings of whole grains per day.~Whole Grain: 3 servings of whole grain"
11256793|NCT02602496|EG000|Reported Event|Control|"3 servings of refined grains per day.~Control: 3 servings of refined grain"
11256794|NCT02602496|EG001|Reported Event|Fruits and Vegetables|"5 servings of fruits and vegetable per day.~Fruits and Vegetables: 5 servings of fruits or vegetables"
11256795|NCT02602496|EG002|Reported Event|Whole Grain|"3 servings of whole grains per day.~Whole Grain: 3 servings of whole grain"
11256796|NCT02603107|BG000|Baseline|B/F/TAF|"Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first."
11256797|NCT02603107|BG001|Baseline|Stay on Baseline Regimen (SBR)|"Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablets or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first."
11256798|NCT02603107|BG002|Baseline|Total|Total of all reporting groups
11256799|NCT02603107|FG000|Participant Flow|B/F/TAF|"Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablet orally once daily for at least 48 weeks, without regard to food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first."
11256800|NCT02603107|FG001|Participant Flow|Stay on Baseline Regimen (SBR)|"Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC tablet or abacavir/lamivudine (ABC/3TC) (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first."
11256801|NCT02603107|OG000|Outcome|B/F/TAF|Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.
11256802|NCT02603107|OG001|Outcome|Stay on Baseline Regimen (SBR)|Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
11256803|NCT02603107|EG000|Reported Event|B/F/TAF (Randomized Phase)|Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.
11256804|NCT02603107|EG001|Reported Event|Stay on Baseline Regimen (SBR) (Randomized Phase)|Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
11256805|NCT02603107|EG002|Reported Event|Extension B/F/TAF From B/F/TAF|After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
11256806|NCT02603107|EG003|Reported Event|Extension B/F/TAF From SBR|After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
11256807|NCT02603120|BG000|Baseline|B/F/TAF|"Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.~OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256808|NCT02603120|BG001|Baseline|ABC/DTG/3TC|"Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.~OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256809|NCT02603120|BG002|Baseline|Total|Total of all reporting groups
11256810|NCT02603120|FG000|Participant Flow|B/F/TAF|"Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food.~Open-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256811|NCT02603120|FG001|Participant Flow|ABC/DTG/3TC|"Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.~OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256812|NCT02603120|OG000|Outcome|B/F/TAF|"Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.~OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256813|NCT02603120|OG001|Outcome|ABC/DTG/3TC|"Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.~OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase."
11256814|NCT02603120|EG000|Reported Event|Double-Blind: B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.
11256815|NCT02603120|EG001|Reported Event|Double-Blind: ABC/DTG/3TC|ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.
11256816|NCT02603120|EG002|Reported Event|Open-label Extension: B/F/TAF From B/F/TAF|Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
11256817|NCT02603120|EG003|Reported Event|Open-label Extension: B/F/TAF From ABC/DTG/3TC|Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
11256818|NCT02603172|BG000|Baseline|GSK3039294 200 mg + GSK3039294 600 mg|In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2.
11256819|NCT02603172|BG001|Baseline|GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD|In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
11256820|NCT02603172|BG002|Baseline|GSK3039294 600 mg +GSK3039294 1200 mg|In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4.
11256821|NCT02603172|BG003|Baseline|GSK3039294 600 mg +GSK3039294 1200 mg/GSK3039294 600 mg QD|In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
11256822|NCT02603172|BG004|Baseline|GSK3039294 600 mg QD|In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
11256823|NCT02603172|BG005|Baseline|GSK3039294 (Cohort 4a)|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256824|NCT02603172|BG006|Baseline|GSK3039294 (Cohort 4b)|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256825|NCT02603172|BG007|Baseline|Part C: GSK3039294|Participants were planned to receive repeat dose of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
11256826|NCT02603172|BG008|Baseline|Total|Total of all reporting groups
11256827|NCT02603172|FG000|Participant Flow|GSK3039294 200 mg + GSK3039294 600 mg|In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 milligram (mg) capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2.
11256828|NCT02603172|FG001|Participant Flow|GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD|In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 milligram (mg) capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, once daily (QD) for 7 days.
11256829|NCT02603172|FG002|Participant Flow|GSK3039294 600 mg +GSK3039294 1200 mg|In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4.
11256830|NCT02603172|FG003|Participant Flow|GSK3039294 600 mg +GSK3039294 1200 mg/GSK3039294 600 mg QD|In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, once daily (QD) for 7 days.
11256831|NCT02603172|FG004|Participant Flow|GSK3039294 600 mg QD|In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
11256832|NCT02603172|FG005|Participant Flow|GSK3039294 (Cohort 4a)|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256833|NCT02603172|FG006|Participant Flow|GSK3039294 (Cohort 4b)|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256834|NCT02603172|FG007|Participant Flow|Part C: GSK3039294|Participants were planned to receive repeat dose of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
11256835|NCT02603172|OG000|Outcome|Part A: GSK3039294 200 mg|Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
11256836|NCT02603172|OG001|Outcome|Part A: GSK3039294 600 mg|Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
11256837|NCT02603172|OG002|Outcome|Part A: GSK3039294 1200 mg|Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
11256838|NCT02603172|OG000|Outcome|Part B: Cohort 3- GSK3039294 600 mg QD|Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
11256839|NCT02603172|OG001|Outcome|Part B: Cohort 4a- GSK3039294|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256840|NCT02603172|OG002|Outcome|Part B: Cohort 4b- GSK3039294|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256841|NCT02603172|OG000|Outcome|Part C: GSK3039294|Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
11256842|NCT02603172|EG000|Reported Event|Part A: GSK3039294 200 mg|Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
11256843|NCT02603172|EG001|Reported Event|Part A: GSK3039294 600 mg|Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
11256844|NCT02603172|EG002|Reported Event|Part A: GSK3039294 1200 mg|Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
11256845|NCT02603172|EG003|Reported Event|Part B: Cohort 3- GSK3039294 600 mg QD|Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
11256846|NCT02603172|EG004|Reported Event|Part B: Cohort 4a- GSK3039294|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256847|NCT02603172|EG005|Reported Event|Part B: Cohort 4b- GSK3039294|Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
11256848|NCT02603172|EG006|Reported Event|Part C: GSK3039294|Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
11256849|NCT02603211|BG000|Baseline|Women With Breast Tumors|"Women with breast tumors.~Tactile imaging sensor or system made in our laboratory: This is a camera with elastomer tip and LED lights. It is a harmless device."
11256850|NCT02603211|FG000|Participant Flow|Women With Breast Tumors|"Women with breast tumors.~tactile imaging sensor or system made in our laboratory: This is a camera with elastomer tip and LED lights. It is a harmless device."
11256851|NCT02603211|OG000|Outcome|Women With Breast Tumors|Women with breast tumors, who come for biopsy are recruited for this study.
11256852|NCT02603211|OG000|Outcome|Women With Breast Tumors|Women with breast tumors who come for biopsy are recruited.
11256853|NCT02603211|EG000|Reported Event|Women With Breast Tumors|"Women with breast tumors.~Tactile imaging sensor or system made in our laboratory: This is a camera with elastomer tip and LED lights. It is a harmless device."
11256854|NCT02603393|BG000|Baseline|QVA149|110/50 μg capsules o.d. for inhalation
11256855|NCT02603393|BG001|Baseline|Tiotropium + Salmeterol/Fluticasone|tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
11256856|NCT02603393|BG002|Baseline|Total|Total of all reporting groups
11256857|NCT02603393|FG000|Participant Flow|QVA149|110/50 μg capsules o.d. for inhalation
11256858|NCT02603393|FG001|Participant Flow|Tiotropium + Salmeterol/Fluticasone|tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
11256859|NCT02603393|OG000|Outcome|QVA149|110/50 μg capsules o.d. for inhalation
11256860|NCT02603393|OG001|Outcome|Tiotropium + Salmeterol/Fluticasone|tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
11256861|NCT02603393|EG000|Reported Event|QVA149|110/50 μg capsules o.d. for inhalation
11256862|NCT02603393|EG001|Reported Event|Tio+Salm/Flut|tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
11256863|NCT02603419|BG000|Baseline|Lead-in Phase: Avelumab 70 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.
11256864|NCT02603419|BG001|Baseline|Lead-in Phase: Avelumab 350 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.
11256865|NCT02603419|BG002|Baseline|Lead-in Phase: Avelumab 500 mg Q3W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.
11256866|NCT02603419|BG003|Baseline|Lead-in Phase: Avelumab 500 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.
11256867|NCT02603419|BG004|Baseline|Lead-in Phase: Avelumab 10 mg/kg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
11256868|NCT02603419|BG005|Baseline|Expansion Phase: Avelumab 70 mg, 500 mg Q2W|All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
11256869|NCT02603419|BG006|Baseline|Total|Total of all reporting groups
11256870|NCT02603419|FG000|Participant Flow|Lead-in Phase: Avelumab 70 mg Q2W|Participants with relapsed/refractory Classical Hodgkins Lymphoma (cHL) received an intravenous (IV) infusion of 70 milligrams (mg) of avelumab, every two weeks (Q2W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.
11256871|NCT02603419|FG001|Participant Flow|Lead-in Phase: Avelumab 350 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.
11256872|NCT02603419|FG002|Participant Flow|Lead-in Phase: Avelumab 500 mg Q3W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, every 3 weeks (Q3W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.
11256873|NCT02603419|FG003|Participant Flow|Lead-in Phase: Avelumab 500 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.
11256874|NCT02603419|FG004|Participant Flow|Lead-in Phase: Avelumab 10 mg/kg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 10 milligrams/kilogram (mg/kg) of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
11256875|NCT02603419|FG005|Participant Flow|Expansion Phase: Avelumab 70 mg, 500 mg Q2W|All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a complete response (CR) at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a partial response (PR) at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a stable disease (SD) at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
11256876|NCT02603419|OG000|Outcome|Lead-in Phase: Avelumab 70 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.
11256877|NCT02603419|OG001|Outcome|Lead-in Phase: Avelumab 350 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.
11256878|NCT02603419|OG002|Outcome|Lead-in Phase: Avelumab 500 mg Q3W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.
11256879|NCT02603419|OG003|Outcome|Lead-in Phase: Avelumab 500 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.
11256880|NCT02603419|OG004|Outcome|Lead-in Phase: Avelumab 10 mg/kg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
11256881|NCT02603419|OG000|Outcome|Expansion Phase: Avelumab 70 mg, 500 mg Q2W|All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
11256882|NCT02603419|OG000|Outcome|Lead-in Phase: Avelumab 70 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks
11256883|NCT02603419|EG000|Reported Event|Lead-in Phase: Avelumab 70 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.
11256884|NCT02603419|EG001|Reported Event|Lead-in Phase: Avelumab 350 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.
11256885|NCT02603419|EG002|Reported Event|Lead-in Phase: Avelumab 500 mg Q3W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.
11256886|NCT02603419|EG003|Reported Event|Lead-in Phase: Avelumab 500 mg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.
11256887|NCT02603419|EG004|Reported Event|Lead-in Phase: Avelumab 10 mg/kg Q2W|Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
11286585|NCT02890992|BG005|Baseline|Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286586|NCT02890992|BG006|Baseline|Cohort 4 - Alirocumab 150 mg Q4W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 12 until Week 48."
11256888|NCT02603419|EG005|Reported Event|Expansion Phase: Avelumab 70 mg, 500 mg Q2W|All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
11256889|NCT02603666|BG000|Baseline|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
11256890|NCT02603666|FG000|Participant Flow|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
11256891|NCT02603666|OG000|Outcome|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
11256892|NCT02603666|EG000|Reported Event|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
11256893|NCT02603809|BG000|Baseline|Placebo|Participants randomized to placebo treatment for 8 weeks.
11256894|NCT02603809|BG001|Baseline|Aprocitentan 5 mg|Participants randomized to 5 mg aprocitentan treatment for 8 weeks.
11256895|NCT02603809|BG002|Baseline|Aprocitentan 10 mg|Participants randomized to 10 mg aprocitentan treatment for 8 weeks.
11256896|NCT02603809|BG003|Baseline|Aprocitentan 25 mg|Participants randomized to 25 mg aprocitentan treatment for 8 weeks.
11256897|NCT02603809|BG004|Baseline|Aprocitentan 50 mg|Participants randomized to 50 mg aprocitentan treatment for 8 weeks.
11256898|NCT02603809|BG005|Baseline|Lisinopril 20 mg|Participants randomized to 20 mg lisinopril treatment for 8 weeks.
11256899|NCT02603809|BG006|Baseline|Total|Total of all reporting groups
11256900|NCT02603809|FG000|Participant Flow|Placebo|After a 4 to 6-week single-blind placebo run-in period, participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256901|NCT02603809|FG001|Participant Flow|Aprocitentan 5 mg|After a 4 to 6-week single-blind placebo run-in period, participants received 5 mg aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256902|NCT02603809|FG002|Participant Flow|Aprocitentan 10 mg|After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256903|NCT02603809|FG003|Participant Flow|Aprocitentan 25 mg|After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256904|NCT02603809|FG004|Participant Flow|Aprocitentan 50 mg|After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256905|NCT02603809|FG005|Participant Flow|Lisinopril 20 mg|After a 4 to 6-week single-blind placebo run-in period, participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256906|NCT02603809|OG000|Outcome|Placebo|One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
11256907|NCT02603809|OG001|Outcome|Aprocitentan 5 mg|One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
11256908|NCT02603809|OG002|Outcome|Aprocitentan 10 mg|Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
11256909|NCT02603809|OG003|Outcome|Aprocitentan 25 mg|One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
11256910|NCT02603809|OG004|Outcome|Aprocitentan 50 mg|One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
11256911|NCT02603809|OG005|Outcome|Lisinopril 20 mg|One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
11256912|NCT02603809|OG000|Outcome|Placebo|One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks
11256913|NCT02603809|OG005|Outcome|Lisinopril 20 mg|"20 mg~Lisinopril: 20 mg capsules orally o.d. for 8 weeks"
11256914|NCT02603809|EG000|Reported Event|Placebo|Participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256915|NCT02603809|EG001|Reported Event|Aprocitentan 5 mg|Participants received aprocitentan 5 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256916|NCT02603809|EG002|Reported Event|Aprocitentan 10 mg|Participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256917|NCT02603809|EG003|Reported Event|Aprocitentan 25 mg|Participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256918|NCT02603809|EG004|Reported Event|Aprocitentan 50 mg|Participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256919|NCT02603809|EG005|Reported Event|Lisinopril 20 mg|Participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
11256920|NCT02603926|BG000|Baseline|Allopregnanolone|"Subjects will receive and intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.~Allopregnanolone"
11256921|NCT02603926|FG000|Participant Flow|Allopregnanolone|Subjects will receive and intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.
11256922|NCT02603926|OG000|Outcome|Allopregnanolone|Subjects will receive and intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.
11256923|NCT02603926|OG000|Outcome|Allopregnanolone|Subjects will receive an intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.
11256924|NCT02603926|EG000|Reported Event|Allopregnanolone|Subjects will receive and intravenous infusion of Allopregnanolone at escalating doses of 2mg, 4mg, and 6mg once weekly over a three week period. The highest dose tolerated without sedation will be held stable for the remaining weekly infusions, for a total of 12 infusions.
11256925|NCT02603952|BG000|Baseline|Placebo + Oseltamivir 75 mg|Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
11256926|NCT02603952|BG001|Baseline|MEDI8852 750 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256927|NCT02603952|BG002|Baseline|MEDI8852 3000 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256928|NCT02603952|BG003|Baseline|MEDI8852 3000 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
11256929|NCT02603952|BG004|Baseline|Total|Total of all reporting groups
11256930|NCT02603952|FG000|Participant Flow|Placebo + Oseltamivir 75 mg|Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
11256931|NCT02603952|FG001|Participant Flow|MEDI8852 750 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256932|NCT02603952|FG002|Participant Flow|MEDI8852 3000 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256933|NCT02603952|FG003|Participant Flow|MEDI8852 3000 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
11256934|NCT02603952|OG000|Outcome|Placebo + Oseltamivir 75 mg|Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
11256935|NCT02603952|OG001|Outcome|MEDI8852 750 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256936|NCT02603952|OG002|Outcome|MEDI8852 3000 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256937|NCT02603952|OG003|Outcome|MEDI8852 3000 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
11256938|NCT02603952|OG000|Outcome|All MEDI8852 Participants|Participants who received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3,000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1.
11256939|NCT02603952|OG000|Outcome|All MEDI8852 Participants|Participants who received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1.
11256940|NCT02603952|OG000|Outcome|All Oseltamivir Participants|Participants who received a single IV infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3,000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256941|NCT02603952|EG000|Reported Event|Placebo + Oseltamivir 75 mg|Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.
11256942|NCT02603952|EG001|Reported Event|MEDI8852 750 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256943|NCT02603952|EG002|Reported Event|MEDI8852 3000 mg + Oseltamivir 75 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.
11256944|NCT02603952|EG003|Reported Event|MEDI8852 3000 mg|Participants received a single IV infusion of MEDI8852 3000 mg on Day 1.
11256945|NCT02604017|BG000|Baseline|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11256946|NCT02604017|BG001|Baseline|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11256947|NCT02604017|BG002|Baseline|Total|Total of all reporting groups
11256948|NCT02604017|FG000|Participant Flow|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11256949|NCT02604017|FG001|Participant Flow|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11256950|NCT02604017|OG000|Outcome|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11256951|NCT02604017|OG001|Outcome|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11256952|NCT02604017|EG000|Reported Event|ABT-493/ABT-530 for 12 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11256953|NCT02604017|EG001|Reported Event|ABT-493/ABT-530 for 8 Weeks|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11256954|NCT02604160|BG000|Baseline|Placebo|0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A.
11256955|NCT02604160|BG001|Baseline|LY3113593|50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
11256956|NCT02604160|BG002|Baseline|Total|Total of all reporting groups
11256957|NCT02604160|FG000|Participant Flow|Placebo|0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A.
11256958|NCT02604160|FG001|Participant Flow|LY3113593|50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
11256959|NCT02604160|OG000|Outcome|Placebo|0.9% saline of placebo administered by IV infusion Q4W (Day 1 and 29) in part A.
11256960|NCT02604160|OG001|Outcome|LY3113593|50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
11256961|NCT02604160|OG000|Outcome|LY3113593|50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
11256962|NCT02604160|OG000|Outcome|LY3113593|50 mg of LY3113593 administered by IV infusion Q4W on (Day 1 and 29) in part A.
11256963|NCT02604160|EG000|Reported Event|Placebo|0.9% saline, administered by slow IV infusion Q4W (Day 1 and 29) in part A.
11256964|NCT02604160|EG001|Reported Event|LY3113593|50 mg of LY3113593 administered by slow IV infusion Q4W (Day 1 and 29) in part A.
11256965|NCT02604173|BG000|Baseline|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256966|NCT02604173|BG001|Baseline|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256967|NCT02604173|BG002|Baseline|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
11256968|NCT02604173|BG003|Baseline|Total|Total of all reporting groups
11256969|NCT02604173|FG000|Participant Flow|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256970|NCT02604173|FG001|Participant Flow|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256971|NCT02604173|FG002|Participant Flow|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
11256972|NCT02604173|OG000|Outcome|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256973|NCT02604173|OG001|Outcome|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256974|NCT02604173|OG002|Outcome|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
11256975|NCT02604173|EG000|Reported Event|Budesonide|"Budesonide inhaler as experimental treatment along with placebo pill.~Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256976|NCT02604173|EG001|Reported Event|Acetazolamide|"Acetazolimide pill as active comparator along with sham inhaler.~Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness"
11256977|NCT02604173|EG002|Reported Event|Control|"Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.~Placebo: Placebo pill and sham inhaler"
11256978|NCT02604199|BG000|Baseline|PBO Low Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256979|NCT02604199|BG001|Baseline|PBO High Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256980|NCT02604199|BG002|Baseline|ARC-520 Injection 1 mg/kg|Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256981|NCT02604199|BG003|Baseline|ARC-520 Injection 2 mg/kg|Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256982|NCT02604199|BG004|Baseline|Total|Total of all reporting groups
11256983|NCT02604199|FG000|Participant Flow|PBO Low Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256984|NCT02604199|FG001|Participant Flow|PBO High Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256985|NCT02604199|FG002|Participant Flow|ARC-520 Injection 1 mg/kg|Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256986|NCT02604199|FG003|Participant Flow|ARC-520 Injection 2 mg/kg|Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256987|NCT02604199|OG000|Outcome|Placebo|Placebo (low dose or high dose) 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256988|NCT02604199|OG001|Outcome|ARC-520 Injection 1 mg/kg|Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256989|NCT02604199|OG002|Outcome|ARC-520 Injection 2 mg/kg|Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256990|NCT02604199|OG000|Outcome|PBO Low Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256991|NCT02604199|OG001|Outcome|PBO High Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256992|NCT02604199|OG002|Outcome|ARC-520 Injection 1 mg/kg|Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256993|NCT02604199|OG003|Outcome|ARC-520 Injection 2 mg/kg|Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256994|NCT02604199|EG000|Reported Event|PBO Low Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256995|NCT02604199|EG001|Reported Event|PBO High Dose|0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256996|NCT02604199|EG002|Reported Event|ARC-520 Injection 1 mg/kg|Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256997|NCT02604199|EG003|Reported Event|ARC-520 Injection 2 mg/kg|Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
11256998|NCT02604212|BG000|Baseline|Placebo Low Dose Comparator|Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11256999|NCT02604212|BG001|Baseline|Placebo High Dose Comparator|Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257000|NCT02604212|BG002|Baseline|ARC-520 1.0 mg/kg|Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257001|NCT02604212|BG003|Baseline|ARC-520 2.0 mg/kg|High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257002|NCT02604212|BG004|Baseline|Total|Total of all reporting groups
11257003|NCT02604212|FG000|Participant Flow|Placebo Low Dose Comparator|Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257004|NCT02604212|FG001|Participant Flow|Placebo High Dose Comparator|Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257005|NCT02604212|FG002|Participant Flow|ARC-520 1.0 mg/kg|Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257006|NCT02604212|FG003|Participant Flow|ARC-520 2.0 mg/kg|High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257007|NCT02604212|OG000|Outcome|Placebo|Placebo (low or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257008|NCT02604212|OG001|Outcome|ARC-520 1.0 mg/kg|Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257009|NCT02604212|OG002|Outcome|ARC-520 2.0 mg/kg|High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257010|NCT02604212|OG000|Outcome|Placebo|Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257011|NCT02604212|OG000|Outcome|Placebo Low Dose Comparator|Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257012|NCT02604212|OG001|Outcome|Placebo High Dose Comparator|Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257013|NCT02604212|OG002|Outcome|ARC-520 1.0 mg/kg|Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257014|NCT02604212|OG003|Outcome|ARC-520 2.0 mg/kg|High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257015|NCT02604212|OG000|Outcome|Placebo High Dose Comparator|Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257016|NCT02604212|EG000|Reported Event|Placebo Low Dose Comparator|Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257017|NCT02604212|EG001|Reported Event|Placebo High Dose Comparator|Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257018|NCT02604212|EG002|Reported Event|ARC-520 1.0 mg/kg|Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257019|NCT02604212|EG003|Reported Event|ARC-520 2.0 mg/kg|High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
11257020|NCT02604264|BG000|Baseline|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
11257021|NCT02604264|BG001|Baseline|Control|Standard hemodialysis end cap
11257022|NCT02604264|BG002|Baseline|Total|Total of all reporting groups
11257023|NCT02604264|FG000|Participant Flow|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
11257024|NCT02604264|FG001|Participant Flow|Control|Standard hemodialysis end cap
11257025|NCT02604264|OG000|Outcome|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
11257026|NCT02604264|OG001|Outcome|Control|Standard hemodialysis end cap
11257027|NCT02604264|EG000|Reported Event|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
11257028|NCT02604264|EG001|Reported Event|Control|Standard hemodialysis end cap
11257029|NCT02604342|BG000|Baseline|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
11257030|NCT02604342|BG001|Baseline|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
11257031|NCT02604342|BG002|Baseline|Total|Total of all reporting groups
11257032|NCT02604342|FG000|Participant Flow|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
11257033|NCT02604342|FG001|Participant Flow|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
11257034|NCT02604342|OG000|Outcome|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
11257035|NCT02604342|OG001|Outcome|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
11257036|NCT02604342|EG000|Reported Event|Experimental: Alectinib|Participants received oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food and treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or death.
11257037|NCT02604342|EG001|Reported Event|Active Comparator: Premetrexed/Docetaxel|Participants received chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously.
11257038|NCT02604407|BG000|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11257039|NCT02604407|BG001|Baseline|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
11257040|NCT02604407|BG002|Baseline|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
11257041|NCT02604407|BG003|Baseline|Total|Total of all reporting groups
11257042|NCT02604407|FG000|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11257043|NCT02604407|FG001|Participant Flow|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
11257044|NCT02604407|FG002|Participant Flow|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
11257045|NCT02604407|OG000|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11257046|NCT02604407|OG001|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
11257047|NCT02604407|OG002|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
11257048|NCT02604407|EG000|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11257049|NCT02604407|EG001|Reported Event|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
11257050|NCT02604407|EG002|Reported Event|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
11257051|NCT02604550|BG000|Baseline|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
11257052|NCT02604550|BG001|Baseline|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
11257053|NCT02604550|BG002|Baseline|Total|Total of all reporting groups
11257054|NCT02604550|FG000|Participant Flow|Femoral Nerve Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
11257055|NCT02604550|FG001|Participant Flow|Adductor Canal Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
11257056|NCT02604550|OG000|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
11257057|NCT02604550|OG001|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
11257058|NCT02604550|EG000|Reported Event|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
11257059|NCT02604550|EG001|Reported Event|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
11257060|NCT02604589|BG000|Baseline|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
11257061|NCT02604589|BG001|Baseline|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
10848082|NCT00288366|BG000|Baseline|Aripiprazole|"aripiprazole (Abilify)~ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
11257062|NCT02604589|BG002|Baseline|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
11257063|NCT02604589|BG003|Baseline|Total|Total of all reporting groups
11257064|NCT02604589|FG000|Participant Flow|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
11257065|NCT02604589|FG001|Participant Flow|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
11257066|NCT02604589|FG002|Participant Flow|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
11257067|NCT02604589|OG000|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
11257068|NCT02604589|OG001|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
11257069|NCT02604589|OG002|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
11257070|NCT02604589|EG000|Reported Event|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
11257071|NCT02604589|EG001|Reported Event|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
11257072|NCT02604589|EG002|Reported Event|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
11257073|NCT02604810|BG000|Baseline|IGIV-C 10% First, IGSC 20% Second|"IV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)~IGIV-C 10%: IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen~After completing the IGIV-C 10% infusions, subjects continued to receive IGSC 20% infusions.~Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)~IGSC 20%: IGSC 20% weekly infusions with dose calculated based on previous IgG regimen"
11257074|NCT02604810|FG000|Participant Flow|IGIV-C 10% First, IGSC 20% Second|"IV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)~IGIV-C 10%: IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen~After completing the IGIV-C 10% infusions, subjects continued to receive IGSC 20% infusions.~Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)~IGSC 20%: IGSC 20% weekly infusions with dose calculated based on previous IgG regimen"
11257075|NCT02604810|OG000|Outcome|IGIV-C 10%|"IV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)~IGIV-C 10%: IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen"
10848083|NCT00288366|BG001|Baseline|Ziprasidone|"ziprasidone (Geodon)~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
10848084|NCT00288366|BG002|Baseline|Total|Total of all reporting groups
11257076|NCT02604810|OG001|Outcome|IGSC 20%|"Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)~IGSC 20%: IGSC 20% weekly infusions with dose calculated based on previous IgG regimen"
11257077|NCT02604810|EG000|Reported Event|IGIV-C 10%|"IV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)~IGIV-C 10%: IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen"
11257078|NCT02604810|EG001|Reported Event|IGSC 20%|"Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)~IGSC 20%: IGSC 20% weekly infusions with dose calculated based on previous IgG regimen"
11257079|NCT02605122|BG000|Baseline|Solithromycin|Solithromycin was dosed for 5-7 days.
11257080|NCT02605122|BG001|Baseline|Standard of Care|Comparators were does up to 10 days per site standard of care.
11257081|NCT02605122|BG002|Baseline|Total|Total of all reporting groups
11257082|NCT02605122|FG000|Participant Flow|Solithromycin|Solithromycin was dosed for 5-7 days. Orally, as capsules or as a suspension, or intravenously. Subjects could receive intravenous therapy initially and switch to an oral formulation.
11257083|NCT02605122|FG001|Participant Flow|Standard of Care|Comparators were dosed according to age and were consistent with current recommendations for treatment of CABP in children per site standard of care.
11257084|NCT02605122|OG000|Outcome|Solithromycin|Solithromycin was dosed for 5-7 days.
11257085|NCT02605122|OG001|Outcome|Standard of Care|Comparators were dosed up to 10 days per site standard of care.
11257086|NCT02605122|EG000|Reported Event|Solithromycin|Solithromycin was dosed for 5-7 days.
11257087|NCT02605122|EG001|Reported Event|Standard of Care|Comparators were dosed up to 10 days per sites standard of care.
11257088|NCT02605174|BG000|Baseline|Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257089|NCT02605174|BG001|Baseline|Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257090|NCT02605174|BG002|Baseline|Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257091|NCT02605174|BG003|Baseline|Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257092|NCT02605174|BG004|Baseline|Total|Total of all reporting groups
11257093|NCT02605174|FG000|Participant Flow|Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257094|NCT02605174|FG001|Participant Flow|Lasmiditan 50 mg/Placebo|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257095|NCT02605174|FG002|Participant Flow|Lasmiditan 100 mg/Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257096|NCT02605174|FG003|Participant Flow|Lasmitidan 100 mg/Placebo|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257097|NCT02605174|FG004|Participant Flow|Lasmiditan 200 mg/Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257098|NCT02605174|FG005|Participant Flow|Lasmitidan 200 mg/Placebo|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257099|NCT02605174|FG006|Participant Flow|Placebo/Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257100|NCT02605174|OG000|Outcome|Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257101|NCT02605174|OG001|Outcome|Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257102|NCT02605174|OG002|Outcome|Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257103|NCT02605174|OG003|Outcome|Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257104|NCT02605174|OG000|Outcome|Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257105|NCT02605174|OG001|Outcome|Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257106|NCT02605174|OG002|Outcome|Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257107|NCT02605174|OG003|Outcome|Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257108|NCT02605174|OG000|Outcome|Lasmiditan 50 mg/Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257109|NCT02605174|OG001|Outcome|Lasmiditan 50 mg/Placebo|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257110|NCT02605174|OG002|Outcome|Lasmiditan 100 mg/Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257111|NCT02605174|OG003|Outcome|Lasmiditan 100 mg/Placebo|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
11257112|NCT02605174|OG004|Outcome|Lasmiditan 200 mg/Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
11257113|NCT02605174|OG005|Outcome|Lasmiditan 200 mg/Placebo|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
11257114|NCT02605174|OG006|Outcome|Placebo/Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257115|NCT02605174|OG000|Outcome|Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257116|NCT02605174|OG001|Outcome|Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257117|NCT02605174|EG000|Reported Event|Lasmiditan 50 mg/Lasmiditan 50 mg|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11213676|NCT02288091|FG000|Participant Flow|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
11213677|NCT02288091|OG000|Outcome|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
11213678|NCT02288091|EG000|Reported Event|Open-label|"Subjects will receive oral inosine daily.~Inosine: Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline."
11213679|NCT02288156|BG000|Baseline|0,1mM|Capsaicin: via nasal spray
11213680|NCT02288156|BG001|Baseline|0,01mM|Capsaicin: via nasal spray
11213681|NCT02288156|BG002|Baseline|0.001mM|Capsaicin: via nasal spray
11213682|NCT02288156|BG003|Baseline|Placebo|placebo: via nasal spray
11213683|NCT02288156|BG004|Baseline|Total|Total of all reporting groups
11213684|NCT02288156|FG000|Participant Flow|0,1mM|Capsaicin: via nasal spray
11213685|NCT02288156|FG001|Participant Flow|0,01mM|Capsaicin: via nasal spray
11213686|NCT02288156|FG002|Participant Flow|0.001mM|Capsaicin: via nasal spray
11213687|NCT02288156|FG003|Participant Flow|Placebo|placebo: via nasal spray
11213688|NCT02288156|OG000|Outcome|0,1mM|Capsaicin: via nasal spray
11213689|NCT02288156|OG001|Outcome|0,01mM|Capsaicin: via nasal spray
11213690|NCT02288156|OG002|Outcome|0.001mM|Capsaicin: via nasal spray
11213691|NCT02288156|OG003|Outcome|Placebo|placebo: via nasal spray
11213692|NCT02288156|OG000|Outcome|0.1mM|Capsaicin: via nasal spray
11213693|NCT02288156|OG001|Outcome|0.01mM|Capsaicin: via nasal spray
11213694|NCT02288156|EG000|Reported Event|0,1mM|Capsaicin: via nasal spray
11213695|NCT02288156|EG001|Reported Event|0,01mM|Capsaicin: via nasal spray
11213696|NCT02288156|EG002|Reported Event|0.001mM|Capsaicin: via nasal spray
11213697|NCT02288156|EG003|Reported Event|Placebo|placebo: via nasal spray
11213698|NCT02288182|BG000|Baseline|Straumann VivOss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213699|NCT02288182|BG001|Baseline|Geistlich Bio-Oss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213700|NCT02288182|BG002|Baseline|Total|Total of all reporting groups
11213701|NCT02288182|FG000|Participant Flow|Straumann VivOss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213702|NCT02288182|FG001|Participant Flow|Geistlich Bio-Oss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213703|NCT02288182|OG000|Outcome|Straumann VivOss|"Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of > 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.~Straumann VivOss: Patients will receive Straumann VivOss for sinus augmentation."
11213704|NCT02288182|OG001|Outcome|Geistlich Bio-Oss|"The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.~Geistlich Bio-Oss: Patients will receive Geistlich Bio-Oss for sinus augmentation."
11213705|NCT02288182|OG000|Outcome|Straumann VivOss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213706|NCT02288182|OG001|Outcome|Geistlich Bio-Oss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213707|NCT02288182|EG000|Reported Event|Straumann VivOss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11213708|NCT02288182|EG001|Reported Event|Geistlich Bio-Oss|Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
11257118|NCT02605174|EG001|Reported Event|Lasmiditan 50 mg/Placebo|Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
11257119|NCT02605174|EG002|Reported Event|Lasmiditan 100 mg/Lasmiditan 100 mg|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257120|NCT02605174|EG003|Reported Event|Lasmiditan 100 mg/Placebo|Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
11257121|NCT02605174|EG004|Reported Event|Lasmiditan 200 mg/Lasmiditan 200 mg|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
11257122|NCT02605174|EG005|Reported Event|Lasmiditan 200 mg/Placebo|Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
11257123|NCT02605174|EG006|Reported Event|Placebo/Placebo|Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.
11257124|NCT02605187|BG000|Baseline|No Choice|"No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257125|NCT02605187|BG001|Baseline|Choice: Low Protocol|"Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (low): Intrathecal morphine dose 50mcg"
11257126|NCT02605187|BG002|Baseline|Choice: Medium Protocol|"Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257127|NCT02605187|BG003|Baseline|Choice: High Protocol|"Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery~Morphine (high): Intrathecal morphine 300mcg"
11257128|NCT02605187|BG004|Baseline|Total|Total of all reporting groups
11257129|NCT02605187|FG000|Participant Flow|No Choice|"No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257130|NCT02605187|FG001|Participant Flow|Choice: Low Protocol|"Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (low): Intrathecal morphine dose 50mcg"
11257131|NCT02605187|FG002|Participant Flow|Choice: Medium Protocol|"Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257132|NCT02605187|FG003|Participant Flow|Choice: High Protocol|"Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery~Morphine (high): Intrathecal morphine 300mcg"
11257133|NCT02605187|OG000|Outcome|No Choice|"No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257134|NCT02605187|OG001|Outcome|Choice: Low Protocol|"Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (low): Intrathecal morphine dose 50mcg"
11257135|NCT02605187|OG002|Outcome|Choice: Medium Protocol|"Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257136|NCT02605187|OG003|Outcome|Choice: High Protocol|"Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery~Morphine (high): Intrathecal morphine 300mcg"
11257137|NCT02605187|EG000|Reported Event|No Choice|"No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
10969920|NCT00908037|OG000|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
10969921|NCT00908037|OG001|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
10969922|NCT00908037|OG002|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
10969923|NCT00908037|OG000|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969924|NCT00908037|OG001|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969925|NCT00908037|OG002|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969926|NCT00908037|OG000|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969927|NCT00908037|OG001|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11257138|NCT02605187|EG001|Reported Event|Choice: Low Protocol|"Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (low): Intrathecal morphine dose 50mcg"
10848085|NCT00288366|FG000|Participant Flow|Aripiprazole|"aripiprazole (Abilify)~ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
10848086|NCT00288366|FG001|Participant Flow|Ziprasidone|"ziprasidone (Geodon)~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
11213709|NCT02288273|BG000|Baseline|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
11213710|NCT02288273|BG001|Baseline|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
11213711|NCT02288273|BG002|Baseline|Total|Total of all reporting groups
11213712|NCT02288273|FG000|Participant Flow|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
11213713|NCT02288273|FG001|Participant Flow|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
11213714|NCT02288273|OG000|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
11213715|NCT02288273|OG001|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
11213716|NCT02288273|EG000|Reported Event|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
11213717|NCT02288273|EG001|Reported Event|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
11213718|NCT02288312|BG000|Baseline|Sequence A|Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
11213719|NCT02288312|BG001|Baseline|Sequence B|Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
11213720|NCT02288312|BG002|Baseline|Sequence C|Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
11213721|NCT02288312|BG003|Baseline|Total|Total of all reporting groups
11213722|NCT02288312|FG000|Participant Flow|Group A|"Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)~Washout periods - 7 days between dosing days"
11213723|NCT02288312|FG001|Participant Flow|Group B|"Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)~Washout periods - 7 days between dosing days"
11213724|NCT02288312|FG002|Participant Flow|Group C|"Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)~Washout periods - 7 days between dosing days"
11213725|NCT02288312|OG000|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
11213726|NCT02288312|OG001|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
11213727|NCT02288312|OG002|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
11213728|NCT02288312|EG000|Reported Event|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
11213729|NCT02288312|EG001|Reported Event|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
11213730|NCT02288312|EG002|Reported Event|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
11213731|NCT02288325|BG000|Baseline|Open-Label FETZIMA®|FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.
11213732|NCT02288325|FG000|Participant Flow|Open-Label FETZIMA®|FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.
11213733|NCT02288325|FG001|Participant Flow|Double-Blind Placebo|Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
11213734|NCT02288325|FG002|Participant Flow|Double-Blind FETZIMA®|FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
11213735|NCT02288325|OG000|Outcome|Double-Blind Placebo|Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
11213736|NCT02288325|OG001|Outcome|Double-Blind FETZIMA®|FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
11213737|NCT02288325|EG000|Reported Event|Open-Label FETZIMA®|FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.
11213738|NCT02288325|EG001|Reported Event|Double-Blind Placebo|Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
11213739|NCT02288325|EG002|Reported Event|Double-Blind FETZIMA®|FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
11213740|NCT02288364|BG000|Baseline|1% Lidocaine|1% Lidocaine alone.
11213741|NCT02288364|BG001|Baseline|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
11213742|NCT02288364|BG002|Baseline|Total|Total of all reporting groups
11213743|NCT02288364|FG000|Participant Flow|1% Lidocaine|1% Lidocaine alone.
11213744|NCT02288364|FG001|Participant Flow|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
11213745|NCT02288364|OG000|Outcome|1% Lidocaine|1% Lidocaine alone.
11213746|NCT02288364|OG001|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
11213747|NCT02288364|EG000|Reported Event|1% Lidocaine|1% Lidocaine alone.
11213748|NCT02288364|EG001|Reported Event|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
11213749|NCT02288377|BG000|Baseline|Placebo|Patients will receive placebo every 28 days until disease progression
11213750|NCT02288377|BG001|Baseline|Lanreotide|Patients will receive lanreotide 120 mg every 28 days until disease progression
11213751|NCT02288377|BG002|Baseline|Total|Total of all reporting groups
11213752|NCT02288377|FG000|Participant Flow|Placebo|Patients will receive placebo every 28 days until disease progression
11213753|NCT02288377|FG001|Participant Flow|Lanreotide|Patients will receive lanreotide 120 mg every 28 days until disease progression
11213754|NCT02288377|OG000|Outcome|Placebo|Patients will receive placebo every 28 days until disease progression
11213755|NCT02288377|OG001|Outcome|Lanreotide|Patients will receive lanreotide 120 mg every 28 days until disease progression
11257139|NCT02605187|EG002|Reported Event|Choice: Medium Protocol|"Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Morphine (med): Intrathecal morphine dose 150mcg"
11257140|NCT02605187|EG003|Reported Event|Choice: High Protocol|"Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose~Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.~Ibuprofen: Ibuprofen 600mg po q6h~Acetaminophen: Acetaminophen 650mg po q6h~Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery~Morphine (high): Intrathecal morphine 300mcg"
11257141|NCT02605304|BG000|Baseline|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
11257142|NCT02605304|BG001|Baseline|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
11257143|NCT02605304|BG002|Baseline|Total|Total of all reporting groups
11257144|NCT02605304|FG000|Participant Flow|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
11257145|NCT02605304|FG001|Participant Flow|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
11257146|NCT02605304|OG000|Outcome|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
11257147|NCT02605304|OG001|Outcome|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
11257148|NCT02605304|EG000|Reported Event|Arm A: LDV/SOF + RBV|Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up.
11257149|NCT02605304|EG001|Reported Event|Arm B: LDV/SOF|Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
11257150|NCT02605395|BG000|Baseline|All Study Participants|Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablets or Idiazole 20 mg gastro-resistant tablets under fed condition in any of the 2 treatment periods. There was a 7 days washout interval between two study drug administration.
11257151|NCT02605395|FG000|Participant Flow|Pariet 20 mg Followed by Idiazole 20 mg|Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablet in period 1 followed by Idiazole 20 mg gastro-resistant tablets in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.
11257152|NCT02605395|FG001|Participant Flow|Idiazole 20 mg Followed by Pariet 20 mg|Eligible participants received a single oral dose of Idiazole 20 mg gastro-resistant tablets in period 1 followed by Pariet 20 mg enteric coated tablet in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.
11257153|NCT02605395|OG000|Outcome|Idiazole 20 mg|Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
11257154|NCT02605395|OG001|Outcome|Pariet 20 mg|Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
11257155|NCT02605395|EG000|Reported Event|Idiazole 20 mg|Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
11257156|NCT02605395|EG001|Reported Event|Pariet 20 mg|Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.
11257157|NCT02605447|BG000|Baseline|SYNERGY Stent + 3 Month DAPT|"Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)~3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin~SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System"
11257158|NCT02605447|FG000|Participant Flow|SYNERGY Stent + 3 Month DAPT|"Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)~3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin~SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System~2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints."
11257159|NCT02605447|OG000|Outcome|SYNERGY Stent + 3 Month DAPT|"Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)~3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin~SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System"
11257160|NCT02605447|OG000|Outcome|SYNERGY Stent + 3 Month DAPT|"Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)~3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin~SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System~2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints."
11257161|NCT02605447|EG000|Reported Event|SYNERGY Stent + 3 Month DAPT|"Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)~3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin~SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System"
11257162|NCT02605642|BG000|Baseline|Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive|BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.
11213756|NCT02288377|EG000|Reported Event|Placebo|Patients will receive placebo every 28 days until disease progression
11213757|NCT02288377|EG001|Reported Event|Lanreotide|Patients will receive lanreotide 120 mg every 28 days until disease progression
11213758|NCT02288559|BG000|Baseline|Sham Q2W|Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
11213759|NCT02288559|BG001|Baseline|Sham Q4W|Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
11213760|NCT02288559|BG002|Baseline|Lampalizumab Q2W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
11213761|NCT02288559|BG003|Baseline|Lampalizumab Q4W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
11213762|NCT02288559|BG004|Baseline|Total|Total of all reporting groups
11213763|NCT02288559|FG000|Participant Flow|Sham Q2W|Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
11213764|NCT02288559|FG001|Participant Flow|Sham Q4W|Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
11213765|NCT02288559|FG002|Participant Flow|Lampalizumab Q2W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
11213766|NCT02288559|FG003|Participant Flow|Lampalizumab Q4W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
11213767|NCT02288559|OG000|Outcome|Sham Q2W|Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
11213768|NCT02288559|OG001|Outcome|Sham Q4W|Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
11213769|NCT02288559|OG002|Outcome|Lampalizumab Q2W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
11213770|NCT02288559|OG003|Outcome|Lampalizumab Q4W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
11213771|NCT02288559|OG000|Outcome|Lampalizumab Q2W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
11213772|NCT02288559|OG000|Outcome|Lampalizumab Q4W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
11213773|NCT02288559|EG000|Reported Event|Lampalizumab Q2W|Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
11213774|NCT02288559|EG001|Reported Event|Lampalizumab Q4W|Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
11213775|NCT02288559|EG002|Reported Event|Sham Q2W|Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
11213776|NCT02288559|EG003|Reported Event|Sham Q4W|Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
11213777|NCT02288819|BG000|Baseline|Loop Diuretic Downtitration|"Scheduled downtitration of maintenance loop diuretic dose while monitoring weight~Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days~Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.~In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.~In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved."
11213778|NCT02288819|FG000|Participant Flow|Loop Diuretic Downtitration|"Scheduled downtitration of maintenance loop diuretic dose while monitoring weight~Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days~Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.~In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.~In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved."
11213779|NCT02288819|OG000|Outcome|Loop Diuretic Downtitration|"Scheduled downtitration of maintenance loop diuretic dose while monitoring weight~Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days~Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.~In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.~In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved."
11213780|NCT02288819|EG000|Reported Event|Loop Diuretic Downtitration|"Scheduled downtitration of maintenance loop diuretic dose while monitoring weight~Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days~Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.~In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.~In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved."
11213781|NCT02289079|BG000|Baseline|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
11213782|NCT02289079|BG001|Baseline|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
11213783|NCT02289079|BG002|Baseline|Total|Total of all reporting groups
11213784|NCT02289079|FG000|Participant Flow|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
11213785|NCT02289079|FG001|Participant Flow|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
11213786|NCT02289079|OG000|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
11213787|NCT02289079|OG001|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
11213788|NCT02289079|EG000|Reported Event|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
11213789|NCT02289079|EG001|Reported Event|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
11257163|NCT02605642|BG001|Baseline|Participants Who Switched From Remicade to CT-P13|Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
11257164|NCT02605642|BG002|Baseline|Total|Total of all reporting groups
11257165|NCT02605642|FG000|Participant Flow|Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive|BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.
11257166|NCT02605642|FG001|Participant Flow|Participants Who Switched From Remicade to CT-P13|Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
11257167|NCT02605642|OG000|Outcome|Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive|BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.
11257168|NCT02605642|OG001|Outcome|Participants Who Switched From Remicade to CT-P13|Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
11257169|NCT02605642|EG000|Reported Event|Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive|BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.
11257170|NCT02605642|EG001|Reported Event|Participants Who Switched From Remicade to CT-P13|Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
11257171|NCT02605837|BG000|Baseline|Placebo|Participants received oral dose of 10 milliliter (ml) placebo matched with the Oral Budesonide Suspension (OBS) twice daily up to 16 weeks.
11257172|NCT02605837|BG001|Baseline|Oral Budesonide Suspension (OBS)|Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks.
11257173|NCT02605837|BG002|Baseline|Total|Total of all reporting groups
11257174|NCT02605837|FG000|Participant Flow|Placebo|Participants received oral dose of 10 milliliter (ml) placebo matched with the Oral Budesonide Suspension (OBS) twice daily up to 16 weeks.
11257175|NCT02605837|FG001|Participant Flow|Oral Budesonide Suspension (OBS)|Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks.
11257176|NCT02605837|OG000|Outcome|Placebo|Participants received oral dose of 10 milliliter (ml) placebo matched with the Oral Budesonide Suspension (OBS) twice daily up to 16 weeks.
11257177|NCT02605837|OG001|Outcome|Oral Budesonide Suspension (OBS)|Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks.
11257178|NCT02605837|OG000|Outcome|Oral Budesonide Suspension (OBS)|Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks.
10969928|NCT00908037|OG002|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11257179|NCT02605837|EG000|Reported Event|Placebo|Participants received oral dose of 10 milliliter (ml) placebo matched with the Oral Budesonide Suspension (OBS) twice daily up to 16 weeks.
11257180|NCT02605837|EG001|Reported Event|Oral Budesonide Suspension (OBS)|Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks.
11257181|NCT02605863|BG000|Baseline|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257182|NCT02605863|BG001|Baseline|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257183|NCT02605863|BG002|Baseline|Total|Total of all reporting groups
11257184|NCT02605863|FG000|Participant Flow|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257185|NCT02605863|FG001|Participant Flow|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257186|NCT02605863|OG000|Outcome|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257187|NCT02605863|OG001|Outcome|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257188|NCT02605863|EG000|Reported Event|Intermediate Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257189|NCT02605863|EG001|Reported Event|High Risk NMIBC|"Enzalutamide 160mg by mouth daily for 12 months~Enzalutamide: 160 mg by mouth daily for 12 months"
11257190|NCT02605876|BG000|Baseline|Whole Body Vibration|"Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Whole body vibration"
11257191|NCT02605876|BG001|Baseline|Local Muscle Vibration|"Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Local muscle vibration"
11257192|NCT02605876|BG002|Baseline|Control|Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
11257193|NCT02605876|BG003|Baseline|Total|Total of all reporting groups
11257194|NCT02605876|FG000|Participant Flow|Whole Body Vibration|"Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Whole body vibration"
11257195|NCT02605876|FG001|Participant Flow|Local Muscle Vibration|"Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Local muscle vibration"
11257196|NCT02605876|FG002|Participant Flow|Control|Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
11257197|NCT02605876|OG000|Outcome|Whole Body Vibration|"Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Whole body vibration"
11257198|NCT02605876|OG001|Outcome|Local Muscle Vibration|"Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Local muscle vibration"
11257199|NCT02605876|OG002|Outcome|Control|Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
11257200|NCT02605876|EG000|Reported Event|Whole Body Vibration|"Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Whole body vibration"
11257201|NCT02605876|EG001|Reported Event|Local Muscle Vibration|"Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.~Local muscle vibration"
11257202|NCT02605876|EG002|Reported Event|Control|Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
11257203|NCT02605928|BG000|Baseline|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
11257204|NCT02605928|FG000|Participant Flow|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
11257205|NCT02605928|OG000|Outcome|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
11257206|NCT02605928|EG000|Reported Event|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
11257207|NCT02605954|BG000|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks
11257208|NCT02605954|BG001|Baseline|ABC/3TC+3rd Agent|ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
11257209|NCT02605954|BG002|Baseline|Total|Total of all reporting groups
11257210|NCT02605954|FG000|Participant Flow|E/C/F/TAF|Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks
11257211|NCT02605954|FG001|Participant Flow|ABC/3TC+3rd Agent|Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
11257212|NCT02605954|OG000|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks
11257213|NCT02605954|OG001|Outcome|ABC/3TC+3rd Agent|ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
11257214|NCT02605954|OG002|Outcome|Delayed E/C/F/TAF|Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
11257215|NCT02605954|EG000|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks
11257216|NCT02605954|EG001|Reported Event|ABC/3TC+3rd Agent|ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
11257217|NCT02605954|EG002|Reported Event|Delayed E/C/F/TAF|Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
11257218|NCT02605954|EG003|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.~Participants received E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food."
11257219|NCT02606253|BG000|Baseline|Metolazone|Metolazone 5mg tablet orally twice daily for 48 hours.
11257220|NCT02606253|BG001|Baseline|Chlorothiazide|Chlorothiazide 500mg intravenous infusion over 30 minutes twice daily for 48 hours
11257221|NCT02606253|BG002|Baseline|Tolvaptan|Tolvaptan 30mg tablet orally once daily for 48 hours
11257222|NCT02606253|BG003|Baseline|Total|Total of all reporting groups
11257223|NCT02606253|FG000|Participant Flow|Metolazone|"Metolazone 5mg tablet orally twice daily for 48 hours.~Metolazone: Metolazone (Zaroxolyn) is an oral thiazide diuretic that works in the distal convoluted tubule of the nephron to cause diuresis."
11257224|NCT02606253|FG001|Participant Flow|Chlorothiazide|"Chlorothiazide 500mg intravenous infusion over 30 minutes twice daily for 48 hours~Chlorothiazide: Chlorothiazide (Diuril) is an intravenous thiazide diuretic that works in the distal convoluted tubule of the nephron to cause diuresis."
11257225|NCT02606253|FG002|Participant Flow|Tolvaptan|"Tolvaptan 30mg tablet orally once daily for 48 hours~tolvaptan: Tolvaptan (Samsca) is a vasopressin 2 receptor antagonist that works in the collecting duct of the nephron to cause diuresis."
11257226|NCT02606253|OG000|Outcome|Metolazone|Metolazone 5mg tablet orally twice daily for 48 hours.
11257227|NCT02606253|OG001|Outcome|Chlorothiazide|Chlorothiazide 500mg intravenous infusion over 30 minutes twice daily for 48 hours
11257228|NCT02606253|OG002|Outcome|Tolvaptan|Tolvaptan 30mg tablet orally once daily for 48 hours
11257229|NCT02606253|EG000|Reported Event|Metolazone|Metolazone 5mg tablet orally twice daily for 48 hours.
11257230|NCT02606253|EG001|Reported Event|Chlorothiazide|Chlorothiazide 500mg intravenous infusion over 30 minutes twice daily for 48 hours
11257231|NCT02606253|EG002|Reported Event|Tolvaptan|Tolvaptan 30mg tablet orally once daily for 48 hours
11257232|NCT02606500|BG000|Baseline|Study Group|"35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram."
11257233|NCT02606500|BG001|Baseline|Control Group|"35 normal weighing women (BMI 19 - 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 - 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.~s."
11257234|NCT02606500|BG002|Baseline|Total|Total of all reporting groups
11257235|NCT02606500|FG000|Participant Flow|Study Group|"35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram."
11257236|NCT02606500|FG001|Participant Flow|Control Group|"35 normal weighing women (BMI 19 - 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 - 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram."
11257237|NCT02606500|OG000|Outcome|Study Group|"35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram."
11286587|NCT02890992|BG007|Baseline|Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48."
11286588|NCT02890992|BG008|Baseline|Total|Total of all reporting groups
11257238|NCT02606500|OG001|Outcome|Control Group|"35 normal weighing women (BMI 19 - 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 - 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram."
11257239|NCT02606500|EG000|Reported Event|Study Group|"35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram."
11257240|NCT02606500|EG001|Reported Event|Control Group|"35 normal weighing women (BMI 19 - 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.~Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 - 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram."
11257241|NCT02606604|BG000|Baseline|FES Cycling|The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).
11257242|NCT02606604|BG001|Baseline|Cycling Only|The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.
11257243|NCT02606604|BG002|Baseline|Total|Total of all reporting groups
11257244|NCT02606604|FG000|Participant Flow|Functional Electrical Stimulation Cycling|The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention.
10969929|NCT00908037|OG000|Outcome|Part 2/ 3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969930|NCT00908037|OG001|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11257245|NCT02606604|FG001|Participant Flow|Cycling Only|The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Seven subjects completed this arm of the intervention.
11257246|NCT02606604|OG000|Outcome|FES Cycling|The intervention consisted of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks for a total of 24 sessions. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training was completed. Seven subjects completed this arm of the intervention. One participant withdrew after the second session of cycling due to developing neck pain and did not continue with the study.
11257247|NCT02606604|OG001|Outcome|Cycling Only|The intervention consisted of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks for at total of 24 sessions. Electrical stimulation was not be applied to any muscles. Outcome measures were collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed. Eight subjects completed this arm of the intervention.
11257248|NCT02606604|OG000|Outcome|FES Cycling|The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).
11257249|NCT02606604|OG001|Outcome|Cycling Only|The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.
11257250|NCT02606604|EG000|Reported Event|FES Cycling|"The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).~RT 300: Lower Extremity Cycling: Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks."
11257251|NCT02606604|EG001|Reported Event|Cycling Only|"The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.~RT 300: Lower Extremity Cycling: Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks."
11257252|NCT02606643|BG000|Baseline|Group 1 Catheter to Slight Traction|Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed.
11257253|NCT02606643|BG001|Baseline|Group 2 Catheter to no Traction|Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to no tension did not have any tension applied to their catheter. After randomization clinicians were not blinded to the allocated group. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed.
11257254|NCT02606643|BG002|Baseline|Total|Total of all reporting groups
11257255|NCT02606643|FG000|Participant Flow|Group 1 Catheter to Slight Traction|68 patients were analyzed in the tension group
11257256|NCT02606643|FG001|Participant Flow|Group 2 Catheter to no Traction|76 patients were analyzed in the no tension group
11257257|NCT02606643|OG000|Outcome|Group 1 Slight Tension|Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed.
11257258|NCT02606643|OG001|Outcome|Group 2 no Tension|Patients randomized to no tension did not have any tension applied to their catheter.
11257259|NCT02606643|OG000|Outcome|Group 1 Slight Tension|Number of Cesarean deliveries in the no tension group
11257260|NCT02606643|OG001|Outcome|Group 2 no Tension|Number of Cesarean deliveries in the no tension group
11257261|NCT02606643|OG000|Outcome|Delivery Within 24 Hours|The primary and secondary outcome data were not normally distributed. Therefore, medians and interquartile ranges are reported and compared. Means and standard deviations for the primary outcome were included in order to facilitate comparisons to other published research.
11257262|NCT02606643|OG001|Outcome|Group 2 no Tension|The primary and secondary outcome data were not normally distributed. Therefore, medians and interquartile ranges are reported and compared. Means and standard deviations for the primary outcome were included in order to facilitate comparisons to other published research.
11257263|NCT02606643|EG000|Reported Event|Group 1|Slight Tension
11257264|NCT02606643|EG001|Reported Event|Group 2|no Tension
11257265|NCT02606708|BG000|Baseline|Accelerated Intensity Modulated Radiation Therapy (AIMRT)|"All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.~Accelerated intensity modulated radiation therapy (AIMRT)"
11257266|NCT02606708|FG000|Participant Flow|Accelerated Intensity Modulated Radiation Therapy (AIMRT)|"All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.~Accelerated intensity modulated radiation therapy (AIMRT)"
11257267|NCT02606708|OG000|Outcome|Accelerated Intensity Modulated Radiation Therapy (AIMRT)|"All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.~Accelerated intensity modulated radiation therapy (AIMRT)"
11257268|NCT02606708|EG000|Reported Event|Accelerated Intensity Modulated Radiation Therapy (AIMRT)|"All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.~Accelerated intensity modulated radiation therapy (AIMRT)"
11257269|NCT02606734|BG000|Baseline|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
11257270|NCT02606734|FG000|Participant Flow|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
11257271|NCT02606734|OG000|Outcome|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
11213790|NCT02289105|BG000|Baseline|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
11213791|NCT02289105|BG001|Baseline|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
11213792|NCT02289105|BG002|Baseline|Total|Total of all reporting groups
11213793|NCT02289105|FG000|Participant Flow|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
11213794|NCT02289105|FG001|Participant Flow|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
11213795|NCT02289105|OG000|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
11213796|NCT02289105|OG001|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
11213797|NCT02289105|EG000|Reported Event|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
11213798|NCT02289105|EG001|Reported Event|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
11213799|NCT02289157|BG000|Baseline|Negative Pressure Wound Therapy|"After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.~Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study."
11213800|NCT02289157|BG001|Baseline|Standard Dressing|After standard cesarean section completed patients will have standard dressing placed.
11213801|NCT02289157|BG002|Baseline|Total|Total of all reporting groups
11213802|NCT02289157|FG000|Participant Flow|Negative Pressure Wound Therapy|"After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.~Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study."
11213803|NCT02289157|FG001|Participant Flow|Standard Dressing|After standard cesarean section completed patients will have standard dressing placed.
11213804|NCT02289157|OG000|Outcome|Negative Pressure Wound Therapy|"After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.~Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study."
11213805|NCT02289157|OG001|Outcome|Standard Dressing|After standard cesarean section completed patients will have standard dressing placed.
11213806|NCT02289157|EG000|Reported Event|Negative Pressure Wound Therapy|"After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.~Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study."
11213807|NCT02289157|EG001|Reported Event|Standard Dressing|After standard cesarean section completed patients will have standard dressing placed.
11213808|NCT02289222|BG000|Baseline|Pomalidomide, Dexamethasone & MK-3475|"Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).~MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.~Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days~Dexamethasone: Dexamethasone is given at 40 mg orally weekly"
11213809|NCT02289222|FG000|Participant Flow|Pomalidomide, Dexamethasone & MK-3475|"Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).~MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.~Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days~Dexamethasone: Dexamethasone is given at 40 mg orally weekly"
11257272|NCT02606734|EG000|Reported Event|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
11257273|NCT02606838|BG000|Baseline|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
11257274|NCT02606838|FG000|Participant Flow|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
11257275|NCT02606838|OG000|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
11257276|NCT02606838|OG000|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
11257277|NCT02606838|OG000|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
11257278|NCT02606838|OG000|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
11257279|NCT02606838|OG000|Outcome|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
10969931|NCT00908037|OG002|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11257280|NCT02606838|EG000|Reported Event|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device System: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
11257281|NCT02606877|BG000|Baseline|Treatment naïve|A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
11257282|NCT02606877|BG001|Baseline|Pirfenidone-treated|Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
11257283|NCT02606877|BG002|Baseline|Total|Total of all reporting groups
11257284|NCT02606877|FG000|Participant Flow|Treatment naïve|A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
11257285|NCT02606877|FG001|Participant Flow|Pirfenidone-treated|Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
11257286|NCT02606877|OG000|Outcome|Nintedanib + Pirfenidone (T1)|A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
11257287|NCT02606877|OG001|Outcome|Nintedanib (R1)|A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
11257288|NCT02606877|OG000|Outcome|Pirfenidone+Nintedanib (T2)|Pirfenidone 801 mg tid was administered in combination with 150 mg bid nintedanib for 7 days.
11257289|NCT02606877|OG001|Outcome|Pirfenidone (R2)|Pirfenidone 801 mg tid was administered alone for 7 days.
11257290|NCT02606877|EG000|Reported Event|Treatment naïve|A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
11257291|NCT02606877|EG001|Reported Event|Pirfenidone-treated|Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
11257292|NCT02606903|BG000|Baseline|BI 695501 Autoinjector (AI)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in auto injector via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Test Product)
11257293|NCT02606903|BG001|Baseline|BI 695501 Pre-filled Syringe (PFS)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in pre-filled syringe via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Reference Product)
11257294|NCT02606903|BG002|Baseline|Total|Total of all reporting groups
11257295|NCT02606903|FG000|Participant Flow|BI 695501 Autoinjector (AI)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in auto injector via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Test Product)
11257296|NCT02606903|FG001|Participant Flow|BI 695501 Pre-filled Syringe (PFS)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in pre-filled syringe via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Reference Product)
11257297|NCT02606903|OG000|Outcome|BI 695501 Autoinjector (AI)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in auto injector via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Test Product)
11257298|NCT02606903|OG001|Outcome|BI 695501 Pre-filled Syringe (PFS)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in pre-filled syringe via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Reference Product)
11257299|NCT02606903|EG000|Reported Event|BI 695501 Autoinjector (AI)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in auto injector via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Test Product)
11257300|NCT02606903|EG001|Reported Event|BI 695501 Pre-filled Syringe (PFS)|Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in pre-filled syringe via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Reference Product)
11257301|NCT02607124|BG000|Baseline|Diffuse Instrinsic Pontine Glioma and Diffuse Midline Glioma|"Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (>21 yrs of age 600mg daily (DIPG); <21 yrs of age 350 mg/m2/day)~Baseline characteristics data are collected irrespective of Arm/Group and cannot be reported separately."
11257302|NCT02607124|FG000|Participant Flow|Non-Biopsied Diffuse Instrinsic Pontine Glioma/Diffuse Midline Glioma|Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (>21 yrs of age 600mg daily (DIPG); <21 yrs of age 350 mg/m2/day)
11257303|NCT02607124|OG000|Outcome|RB+ High Grade Glioma|"Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (>21 yrs of age 600mg daily (DIPG); <21 yrs of age 350 mg/m2/day)~Ribociclib"
11257304|NCT02607124|OG001|Outcome|Non-Biopsied Diffuse Instrinsic Pontine Glioma|"Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (>21 yrs of age 600mg daily (DIPG); <21 yrs of age 350 mg/m2/day)~Ribociclib"
11257305|NCT02607124|EG000|Reported Event|Diffuse Intrinsic Pontine Glioma and High Grade Glioma|Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (>21 yrs of age 600mg daily (DIPG); <21 yrs of age 350 mg/m2/day)
11257306|NCT02607228|BG000|Baseline|Monotherapy: Alobresib 2 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD).
11257307|NCT02607228|BG001|Baseline|Monotherapy: Alobresib 3 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD.
11257308|NCT02607228|BG002|Baseline|Monotherapy: Alobresib 4 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD.
11257309|NCT02607228|BG003|Baseline|Monotherapy: Alobresib 6 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD.
11257310|NCT02607228|BG004|Baseline|Monotherapy: Alobresib 9 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD.
11257311|NCT02607228|BG005|Baseline|Combination Therapy: Alobresib 3 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257312|NCT02607228|BG006|Baseline|Combination Therapy: Alobresib 6 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257313|NCT02607228|BG007|Baseline|Total|Total of all reporting groups
11257314|NCT02607228|FG000|Participant Flow|Monotherapy: Alobresib 2 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD).
11257315|NCT02607228|FG001|Participant Flow|Monotherapy: Alobresib 3 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD.
11257316|NCT02607228|FG002|Participant Flow|Monotherapy: Alobresib 4 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD.
11257317|NCT02607228|FG003|Participant Flow|Monotherapy: Alobresib 6 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD.
11257318|NCT02607228|FG004|Participant Flow|Monotherapy: Alobresib 9 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD.
11257319|NCT02607228|FG005|Participant Flow|Combination Therapy: Alobresib 3 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257320|NCT02607228|FG006|Participant Flow|Combination Therapy: Alobresib 6 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257321|NCT02607228|OG000|Outcome|Monotherapy: Alobresib 2 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD).
11257322|NCT02607228|OG001|Outcome|Monotherapy: Alobresib 3 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD.
11257323|NCT02607228|OG002|Outcome|Monotherapy: Alobresib 4 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD.
11257324|NCT02607228|OG003|Outcome|Monotherapy: Alobresib 6 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD.
11257325|NCT02607228|OG004|Outcome|Monotherapy: Alobresib 9 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD.
11257326|NCT02607228|OG005|Outcome|Combination Therapy: Alobresib 3 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257327|NCT02607228|OG006|Outcome|Combination Therapy: Alobresib 6 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257328|NCT02607228|OG000|Outcome|Monotherapy: Alobresib 2 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the MTD.
11257329|NCT02607228|EG000|Reported Event|Monotherapy: Alobresib 2 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD).
11257330|NCT02607228|EG001|Reported Event|Monotherapy: Alobresib 3 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD.
11257331|NCT02607228|EG002|Reported Event|Monotherapy: Alobresib 4 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD.
11257332|NCT02607228|EG003|Reported Event|Monotherapy: Alobresib 6 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD.
11257333|NCT02607228|EG004|Reported Event|Monotherapy: Alobresib 9 mg|Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD.
11257334|NCT02607228|EG005|Reported Event|Combination Therapy: Alobresib 3 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257335|NCT02607228|EG006|Reported Event|Combination Therapy: Alobresib 6 mg + Enzalutamide|Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily.
11257336|NCT02607254|BG000|Baseline|Pregabalin Treatment/Pregabalin Withdrawal|All patients will were with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
11257337|NCT02607254|BG001|Baseline|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
11257338|NCT02607254|BG002|Baseline|Pregabalin Treatment/ No Withdrawal|After finishing the pregabalin treatment phase for 8 weeks, these patients did not qualify to continue to withdrawal phase.
11257339|NCT02607254|BG003|Baseline|Total|Total of all reporting groups
11257340|NCT02607254|FG000|Participant Flow|Pregabalin Treatment/Pregabalin Withdrawal|Patients in this arm were initially treated with pregabalin in a single blind fashion. After 8 weeks of treatment, they were randomized to continue on pregabalin for 4 weeks in the double blind randomized withdrawal phase as their pain was improved per protocol.
11257341|NCT02607254|FG001|Participant Flow|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin single-blinded treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase for 4 weeks as their pain was improved during treatment phase.
11257342|NCT02607254|FG002|Participant Flow|Pregabalin Treatment/No Withdrwal|These patients were treated with Pregabalin, but did not qualify for withdrawal phase as their pain did not improve to meet the criteria to enter the withdrawal phase.
11257343|NCT02607254|OG000|Outcome|Pregabalin Treatment/Pregabalin Withdrawal|All patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin.
11257344|NCT02607254|OG001|Outcome|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
11257345|NCT02607254|OG002|Outcome|Pregabalin Treatment/No Withdrwal|After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase.
11257346|NCT02607254|OG000|Outcome|Pregabalin Treatment/Pregabalin Withdrawal|These patients were initially treated with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin if their pain is controlled.
11257347|NCT02607254|OG001|Outcome|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin treatment phase, these patients were randomized to the placebo arm for the withdrawal phase.
11257348|NCT02607254|OG002|Outcome|Pregabalin Treatment/No Withdrwal|These patients did not qualify for the withdrawal phase after finishing the 8 weeks of pregabalin treatment.
11257349|NCT02607254|OG000|Outcome|Pregabalin Treatment/Pregabalin Withdrawal|These patients were initially treated with pregabalin. After 8 weeks of treatment, They were randomized to continue on pregabalin.
11257350|NCT02607254|OG001|Outcome|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin treatment phase,these patients were randomized to the placebo arm for the withdrawal phase.
11257351|NCT02607254|OG001|Outcome|Pregabalin Treatment/ Placebo Withdrawal|After finishing the 8 weeks of pregabalin treatment these patients were randomized to the placebo arm for the withdrawal phase.
11257352|NCT02607254|EG000|Reported Event|Pregabalin Treatment/Pregabalin Withdrawal|Patients in this arm were initially treated with pregabalin in a single blind fashion. After 8 weeks of treatment, they were randomized to continue on pregabalin for 4 weeks in the double blind randomized withdrawal phase as their pain was improved per protocol.
11257353|NCT02607254|EG001|Reported Event|Pregabalin Treatment/ Placebo Withdrawal|After finishing the pregabalin single-blinded treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase for 4 weeks as their pain was improved during treatment phase
11257354|NCT02607254|EG002|Reported Event|Pregabalin Treatment/No Withdrawal|These patients were treated with Pregabalin, but did not qualify for withdrawal phase as their pain did not improve to meet the criteria to enter the withdrawal phase.
11257355|NCT02607280|BG000|Baseline|Moderate Renal Impairment|Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
11257356|NCT02607280|BG001|Baseline|Severe Renal Impairment|Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
11257357|NCT02607280|BG002|Baseline|Total|Total of all reporting groups
11257358|NCT02607280|FG000|Participant Flow|Moderate Renal Impairment|Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
11257359|NCT02607280|FG001|Participant Flow|Severe Renal Impairment|Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
11257360|NCT02607280|OG000|Outcome|Moderate Renal Impairment|Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
11257361|NCT02607280|OG001|Outcome|Severe Renal Impairment|Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
11257362|NCT02607280|EG000|Reported Event|Moderate Renal Impairment|Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
11257363|NCT02607280|EG001|Reported Event|Severe Renal Impairment|Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
11257364|NCT02607306|BG000|Baseline|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257365|NCT02607306|BG001|Baseline|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257366|NCT02607306|BG002|Baseline|Liraglutide|Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257367|NCT02607306|BG003|Baseline|Total|Total of all reporting groups
11257368|NCT02607306|FG000|Participant Flow|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257369|NCT02607306|FG001|Participant Flow|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257370|NCT02607306|FG002|Participant Flow|Liraglutide|Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257371|NCT02607306|OG000|Outcome|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257372|NCT02607306|OG001|Outcome|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257373|NCT02607306|OG002|Outcome|Liraglutide|Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257374|NCT02607306|OG001|Outcome|Liraglutide|Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257375|NCT02607306|EG000|Reported Event|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257376|NCT02607306|EG001|Reported Event|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257377|NCT02607306|EG002|Reported Event|Liraglutide|Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.
11257378|NCT02607618|BG000|Baseline|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~Iclaprim: Experimental treatment"
11257379|NCT02607618|BG001|Baseline|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~Vancomycin: Active comparator"
11257380|NCT02607618|BG002|Baseline|Total|Total of all reporting groups
11257381|NCT02607618|FG000|Participant Flow|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~Iclaprim: Experimental treatment"
11257382|NCT02607618|FG001|Participant Flow|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~Vancomycin: Active comparator"
11257383|NCT02607618|OG000|Outcome|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~Iclaprim: Experimental treatment"
11257384|NCT02607618|OG001|Outcome|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~Vancomycin: Active comparator"
11257385|NCT02607618|EG000|Reported Event|Iclaprim|"iclaprim 80 mg intravenous every 12 hours~Iclaprim: Experimental treatment"
11257386|NCT02607618|EG001|Reported Event|Vancomycin|"vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance~Vancomycin: Active comparator"
11257387|NCT02607735|BG000|Baseline|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11257388|NCT02607735|BG001|Baseline|Placebo (Primary Study)|Placebo tablet orally once daily with food for 12 weeks
11257389|NCT02607735|BG002|Baseline|Total|Total of all reporting groups
11257390|NCT02607735|FG000|Participant Flow|SOF/VEL/VOX (Primary Study)|Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
11257391|NCT02607735|FG001|Participant Flow|Placebo (Primary Study)|Placebo tablet orally once daily with food for 12 weeks
11257392|NCT02607735|FG002|Participant Flow|SOF/VEL/VOX (Deferred Treatment Substudy)|Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks.
11257393|NCT02607735|OG000|Outcome|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11257394|NCT02607735|OG001|Outcome|Placebo (Primary Study)|Placebo tablet orally once daily with food for 12 weeks
11257395|NCT02607735|OG000|Outcome|SOF/VEL/VOX (Deferred Treatment Substudy)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11257396|NCT02607735|EG000|Reported Event|SOF/VEL/VOX (Primary Study)|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11257397|NCT02607735|EG001|Reported Event|Placebo (Primary Study)|Placebo tablet orally once daily with food for 12 weeks
11257398|NCT02607735|EG002|Reported Event|SOF/VEL/VOX (Deferred Treatment Substudy)|"Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy.~SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks"
11257399|NCT02607800|BG000|Baseline|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
11257400|NCT02607800|BG001|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
11257401|NCT02607800|BG002|Baseline|Total|Total of all reporting groups
11257402|NCT02607800|FG000|Participant Flow|SOF/VEL/VOX 8 Weeks|Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 weeks
11257403|NCT02607800|FG001|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
11257404|NCT02607800|OG000|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
11257405|NCT02607800|OG001|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
11257406|NCT02607800|OG000|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
11257407|NCT02607800|EG000|Reported Event|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
11257408|NCT02607800|EG001|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
11257409|NCT02607865|BG000|Baseline|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257410|NCT02607865|BG001|Baseline|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257411|NCT02607865|BG002|Baseline|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257412|NCT02607865|BG003|Baseline|Sitagliptin 100 mg|Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
11257413|NCT02607865|BG004|Baseline|Total|Total of all reporting groups
11257414|NCT02607865|FG000|Participant Flow|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257415|NCT02607865|FG001|Participant Flow|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257416|NCT02607865|FG002|Participant Flow|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257417|NCT02607865|FG003|Participant Flow|Sitagliptin 100 mg|Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
11257418|NCT02607865|OG000|Outcome|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257419|NCT02607865|OG001|Outcome|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257420|NCT02607865|OG002|Outcome|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257421|NCT02607865|OG003|Outcome|Sitagliptin 100 mg|Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
11257422|NCT02607865|EG000|Reported Event|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257423|NCT02607865|EG001|Reported Event|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257424|NCT02607865|EG002|Reported Event|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.
11257425|NCT02607865|EG003|Reported Event|Sitagliptin 100 mg|Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
11257426|NCT02608099|BG000|Baseline|Interrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11257427|NCT02608099|BG001|Baseline|Uninterrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11257428|NCT02608099|BG002|Baseline|Total|Total of all reporting groups
11257429|NCT02608099|FG000|Participant Flow|Interrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11257430|NCT02608099|FG001|Participant Flow|Uninterrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11257431|NCT02608099|OG000|Outcome|Interrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11257432|NCT02608099|OG001|Outcome|Uninterrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration."
11337404|NCT03583606|FG000|Participant Flow|ChAd3-EBO-Z + Placebo|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).~Placebo: 0.5 mL normal saline administered via IM injection into the deltoid."
11257433|NCT02608099|EG000|Reported Event|Interrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~A total of 149 patients were included in the Interrupted Apixaban arm from the safety population (patients were analyzed under the actual treatment received)."
11257434|NCT02608099|EG001|Reported Event|Uninterrupted Apixaban|"Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.~A total of 151 patients were included in the Uninterrupted Apixaban arm from the safety population (patients were analyzed under the actual treatment received)."
11257435|NCT02608177|BG000|Baseline|Linagliptin/Glipizide|"Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257436|NCT02608177|BG001|Baseline|Glipizide/Linagliptin|"Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257437|NCT02608177|BG002|Baseline|Total|Total of all reporting groups
11257438|NCT02608177|FG000|Participant Flow|Linagliptin/Glipizide|"Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257439|NCT02608177|FG001|Participant Flow|Glipizide/Linagliptin|"Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257440|NCT02608177|OG000|Outcome|Glipizide|Outcome assessed among all participants in both treatment groups at the end of treatment with Glipizide for 4 weeks.
11257441|NCT02608177|OG001|Outcome|Linagliptin|Outcome assessed among all participants in both treatment groups at the end of treatment with Linagliptin for 4 weeks.
11257442|NCT02608177|OG000|Outcome|Linagliptin/Glipizide|"Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257443|NCT02608177|OG001|Outcome|Glipizide/Linagliptin|"Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257444|NCT02608177|EG000|Reported Event|Linagliptin/Glipizide|"Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257445|NCT02608177|EG001|Reported Event|Glipizide/Linagliptin|"Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin~Linagliptin: Receives 4 weeks of study drug linagliptin~Glipizide: Receives 4 weeks of study drug glipizide"
11257446|NCT02608229|BG000|Baseline|Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals).~BVD-523 at 600 mg twice daily on its own for two weeks before initiating Cycle 1 treatment with gemcitabine and nab-paclitaxel.~Nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes.~Mandatory biopsy at baseline and baseline at end of 2 week BVD-523 lead in."
11257447|NCT02608229|BG001|Baseline|Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~First 2 patients enrolled: BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Remaining 6 patients enrolled: BVD-523 450 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 800 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Mandatory biopsy at baseline and at end of cycle 2 (if deemed safe for participant and feasible to obtain)"
11257448|NCT02608229|BG002|Baseline|Total|Total of all reporting groups
11257449|NCT02608229|FG000|Participant Flow|Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals).~BVD-523 at 600 mg twice daily on its own for two weeks before initiating Cycle 1 treatment with gemcitabine and nab-paclitaxel.~Nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes.~Mandatory biopsy at baseline and baseline at end of 2 week BVD-523 lead in."
11257450|NCT02608229|FG001|Participant Flow|Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~First 2 patients enrolled: BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Remaining 6 patients enrolled: BVD-523 450 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 800 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Mandatory biopsy at baseline and at end of cycle 2 (if deemed safe for participant and feasible to obtain)"
11257451|NCT02608229|OG000|Outcome|Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals).~BVD-523 at 600 mg twice daily on its own for two weeks before initiating Cycle 1 treatment with gemcitabine and nab-paclitaxel.~Nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes.~Mandatory biopsy at baseline and baseline at end of 2 week BVD-523 lead in."
11257452|NCT02608229|OG001|Outcome|Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~First 2 patients enrolled: BVD-523 600 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Remaining 6 patients enrolled: BVD-523 450 mg on a twice daily basis (at approximately 12-hour intervals), nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes, and gemcitabine 800 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes~Mandatory biopsy at baseline and at end of cycle 2 (if deemed safe for participant and feasible to obtain)"
11257453|NCT02608229|OG000|Outcome|600 mg BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~All patients who received 600 mg BVD-523 on a twice daily basis (at approximately 12-hour intervals) are included in this group~Nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes."
11257454|NCT02608229|OG001|Outcome|450 mg BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~All patients who received 450 mg BVD-523 on a twice daily basis (at approximately 12-hour intervals) are included in this group~Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 800 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes."
11257455|NCT02608229|EG000|Reported Event|600 mg BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~All patients who received 600 mg BVD-523 on a twice daily basis (at approximately 12-hour intervals) are included in this group~Nab-paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes."
11257456|NCT02608229|EG001|Reported Event|450 mg BVD-523/Nab-paclitaxel/Gemcitabine|"Treatment will be given in a 28-day cycle.~All patients who received 450 mg BVD-523 on a twice daily basis (at approximately 12-hour intervals) are included in this group~Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30-40 minutes.~Gemcitabine 800 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle over the course of 30 minutes."
11257457|NCT02608450|BG000|Baseline|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris."
11257458|NCT02608450|BG001|Baseline|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257459|NCT02608450|BG002|Baseline|Total|Total of all reporting groups
10969932|NCT00908037|OG000|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a body weight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969933|NCT00908037|OG001|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
10969934|NCT00908037|OG002|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969935|NCT00908037|OG003|Outcome|Part 2/3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
11257460|NCT02608450|FG000|Participant Flow|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris."
11257461|NCT02608450|FG001|Participant Flow|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257462|NCT02608450|OG000|Outcome|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris."
10969936|NCT00908037|OG000|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969937|NCT00908037|OG003|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
10969938|NCT00908037|OG000|Outcome|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
10969939|NCT00908037|OG001|Outcome|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
10969940|NCT00908037|OG002|Outcome|Part 2 (Randomized Period) - Eltrombopag|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
10969941|NCT00908037|OG002|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
10969942|NCT00908037|OG000|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969943|NCT00908037|OG001|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
11213810|NCT02289222|OG000|Outcome|Pomalidomide, Dexamethasone & MK-3475|"Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).~MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.~Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days~Dexamethasone: Dexamethasone is given at 40 mg orally weekly"
11213811|NCT02289222|EG000|Reported Event|Pomalidomide, Dexamethasone & MK-3475|"Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).~MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.~Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days~Dexamethasone: Dexamethasone is given at 40 mg orally weekly"
11213812|NCT02289352|BG000|Baseline|Test:Brimonidine 0.33% Gel|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213813|NCT02289352|BG001|Baseline|Reference: Mirvaso 0.33% Gel|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213814|NCT02289352|BG002|Baseline|Placebo Gel Vehicle|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213815|NCT02289352|BG003|Baseline|Total|Total of all reporting groups
11213816|NCT02289352|FG000|Participant Flow|Test: Brimonidine 0.33% Gel|"Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA)~Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days)."
11213817|NCT02289352|FG001|Participant Flow|Reference: Mirvaso 0.33% Gel|"Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA)~Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days)."
11213818|NCT02289352|FG002|Participant Flow|Placebo Gel Vehicle|"Topical gel base only (Watson Laboratories Inc., USA)~Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days)."
11213819|NCT02289352|OG000|Outcome|Test: Brimonidine 0.33% Gel|"Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA)~Test Brimonidine"
11213820|NCT02289352|OG001|Outcome|Reference: Mirvaso 0.33% Gel|"Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA)~Reference Brimonidine"
11213821|NCT02289352|OG002|Outcome|Placebo|Vehicle gel
11213822|NCT02289352|OG002|Outcome|Placebo|Placebo Vehicle gel
11213823|NCT02289352|EG000|Reported Event|Test:Brimonidine 0.33% Gel|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213824|NCT02289352|EG001|Reported Event|Reference: Mirvaso 0.33% Gel|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213825|NCT02289352|EG002|Reported Event|Placebo Gel Vehicle|Participants applies a once-daily application of brimonidine gel (pea-sized amount to each of 5 areas of the entire face for 7 days).
11213826|NCT02289417|BG000|Baseline|Placebo|Participants were randomized to identically matching placebo capsules and received placebo capsules by mouth PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213827|NCT02289417|BG001|Baseline|Apremilast 30 mg|Participants were randomized to apremilast 30 mg capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213828|NCT02289417|BG002|Baseline|Apremilast 40 mg|Participants were randomized to 40 mg apremilast capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213829|NCT02289417|BG003|Baseline|Total|Total of all reporting groups
11213830|NCT02289417|FG000|Participant Flow|Placebo|Participants were randomized to identically matching placebo capsules and received placebo capsules by mouth (PO) twice a day (BID) for 12 weeks during the double-blind placebo-controlled phase.
11213831|NCT02289417|FG001|Participant Flow|Apremilast 30 mg|"Participants were randomized to apremilast 30 mg capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.~At week 12, participants who achieved at least a 20% decrease from baseline in the total Mayo score (TMS) continued to receive 30 mg apremilast capsules BID for an additional 40 weeks during the active treatment phase."
11213832|NCT02289417|FG002|Participant Flow|Apremilast 40 mg|Participants were randomized to 40 mg apremilast capsules PO BID for 12 weeks during the double-blind placebo-controlled phase. At week 12, participants who achieved at least a 20% decrease from baseline in the TMS continued to receive 40 mg apremilast capsules BID for an additional 40 weeks during the active treatment phase.
11213833|NCT02289417|FG003|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to placebo capsules in the placebo-controlled period were re-randomized at week 12 to receive 30 mg apremilast capsules BID for 40 weeks during the active treatment phase.
11213834|NCT02289417|FG004|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to placebo in the placebo-controlled period were re-randomized at week 12 to receive 40 mg apremilast capsules BID for 40 weeks during the active treatment phase.
11213835|NCT02289417|FG005|Participant Flow|Apremilast 30 mg/Apremilast 40 mg|Participants initially randomized to 30 mg apremilast capsules BID in the placebo-controlled phase who did not achieve at least a 20% decrease from baseline in the TMS were re-assigned to 40 mg apremilast capsules BID for 40 weeks during the active treatment phase.
11213836|NCT02289417|FG006|Participant Flow|Apremilast 40 mg/ Apremilast 40 mg|Participants initially randomized to 40 mg apremilast capsules BID in the placebo-controlled phase who did not achieve at least a 20% decrease from baseline in the TMS continued to receive 40 mg apremilast capsules BID for an additional 40 weeks during the active treatment phase.
11213837|NCT02289417|FG007|Participant Flow|Extension Phase: Apremilast 30 mg|Participants who completed 52 weeks of treatment and had a Mayo endoscopy score ≤ 1 at week 52 were eligible to participate in the 52-week extension phase and receive 30 mg apremilast BID for an additional 52 weeks. This includes participants assigned to 30 mg apremilast BID at week 12, and participants who entered the extension phase after implementation of Protocol Amendment 4.
11213838|NCT02289417|FG008|Participant Flow|Extension Phase Apremilast 40 mg|Participants who completed 52 weeks of treatment and had a Mayo endoscopy score ≤ 1 at week 52 were eligible to participate in the 52-week extension phase and receive 40 mg apremilast BID for an additional 52 weeks. After implementation of Protocol Amendment 4 participants were switched to 30 mg apremilast BID for the remainder of the extension phase.
11213839|NCT02289417|OG000|Outcome|Placebo|Participants were randomized to identically matching placebo capsules and received placebo capsules by mouth (PO) twice a day (BID) for 12 weeks during the double-blind placebo-controlled phase.
11213840|NCT02289417|OG001|Outcome|Apremilast 30 mg|Participants were randomized to apremilast 30 mg capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213841|NCT02289417|OG002|Outcome|Apremilast 40 mg|Participants were randomized to 40 mg apremilast capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213842|NCT02289417|OG000|Outcome|Apremilast 30 mg|TEAEs during the apremilast 30 mg BID treatment for participants who received 30 mg apremilast capsules BID only and participants who initially received 30 mg apremilast capsules BID and switched to 40 mg apremilast capsules BID at Week 12, and participants who initially received placebo capsules BID and switched to 30 mg apremilast capsules BID at Week 12.
11213843|NCT02289417|OG001|Outcome|Apremilast 40 mg|TEAEs during the apremilast 40 mg BID treatment for participants who received 40 mg apremilast capsules BID only, and participants who initially received placebo BID and switched to 40 mg apremilast capsules BID at Week 12.
11213844|NCT02289417|OG002|Outcome|Apremilast 30 mg/Apremilast 40 mg|TEAEs during the apremilast 40 mg BID treatment for participants who initially received 30 mg apremilast BID and switched to apremilast 40 mg BID at Week 12.
11257463|NCT02608450|OG001|Outcome|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257464|NCT02608450|EG000|Reported Event|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris."
11257465|NCT02608450|EG001|Reported Event|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257466|NCT02608463|BG000|Baseline|Neuropathic Pain Group|≥13 on the painDETECT Questionnaire (PDQ)
11257467|NCT02608463|BG001|Baseline|Non-Neuropathic Pain Group|score of ≥1 or ≤12 on the PDQ
11257468|NCT02608463|BG002|Baseline|Controls|Patients without neuropathic pain receiving care as usual.
11257469|NCT02608463|BG003|Baseline|Total|Total of all reporting groups
11257470|NCT02608463|FG000|Participant Flow|Part A: Neuropathic Pain Group|≥13 on the painDETECT Questionnaire (PDQ) 10 subjects
11257471|NCT02608463|FG001|Participant Flow|Part A: Non-Neuropathic Pain Group|≥1 and ≤12 on the PDQ 5 subjects
11257472|NCT02608463|FG002|Participant Flow|Part A: Controls|Patients without neuropathic pain receiving care as usual.
11257473|NCT02608463|FG003|Participant Flow|Part B Participants|No participants were ever enrolled in Part B, so this group has been dropped from all future sections.
11257474|NCT02608463|OG000|Outcome|Neuropathic Pain Group|≥13 on the painDETECT Questionnaire (PDQ) 10 subjects
11257475|NCT02608463|OG001|Outcome|Non-Neuropathic Pain Group|≥1 and ≤12 on the PDQ 5 subjects
11257476|NCT02608463|OG002|Outcome|Control|Patients without neuropathic pain receiving care as usual. Due to n=0, no statistical analysis was completed.
11257477|NCT02608463|EG000|Reported Event|Neuropathic Pain Group|"score of ≥13 on the PDQ~Total Serious Adverse Events: 6 Number of Participants Affected by Serious Adverse Events: 3~Total Adverse Events: 62 Number of Participants Affected by Adverse Events: 8"
11257478|NCT02608463|EG001|Reported Event|Non-Neuropathic Pain Group|"score of ≥ 1 or ≤ 12 on the PDQ~Total Serious Adverse Events: 40 Number of Participants Affected by Serious Adverse Events: 3~Total Adverse Events: 39 Number of Participants Affected by Adverse Events: 5"
11257479|NCT02608463|EG002|Reported Event|Controls|"score of 0 on the PDQ~Total Serious Adverse Events: 0 Number of Participants Affected by Serious Adverse Events: 0~Total Adverse Events: 0 Number of Participants Affected by Adverse Events: 0"
10848087|NCT00288366|OG000|Outcome|Aripiprazole|"aripiprazole (Abilify)~ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
11257480|NCT02608476|BG000|Baseline|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11257481|NCT02608476|BG001|Baseline|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257482|NCT02608476|BG002|Baseline|Total|Total of all reporting groups
11257483|NCT02608476|FG000|Participant Flow|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11257484|NCT02608476|FG001|Participant Flow|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257485|NCT02608476|OG000|Outcome|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11257486|NCT02608476|OG001|Outcome|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257487|NCT02608476|EG000|Reported Event|CB-03-01 Cream|"CB-03-01 cream, 1% applied twice daily for 12 weeks~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11257488|NCT02608476|EG001|Reported Event|Vehicle Cream|"Vehicle cream applied twice daily for 12 weeks~Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate."
11257489|NCT02608489|BG000|Baseline|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
11257490|NCT02608489|BG001|Baseline|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
11257491|NCT02608489|BG002|Baseline|Total|Total of all reporting groups
11257492|NCT02608489|FG000|Participant Flow|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
11257493|NCT02608489|FG001|Participant Flow|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
11257494|NCT02608489|OG000|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
10848088|NCT00288366|OG001|Outcome|Ziprasidone|"ziprasidone (Geodon)~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
10848089|NCT00288366|EG000|Reported Event|Aripiprazole|"aripiprazole (Abilify)~ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
10848090|NCT00288366|EG001|Reported Event|Ziprasidone|"ziprasidone (Geodon)~aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert"
10848091|NCT00288509|BG000|Baseline|Dysport|250-1000 units
11257495|NCT02608489|OG001|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
11257496|NCT02608489|EG000|Reported Event|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
11257497|NCT02608489|EG001|Reported Event|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
11257498|NCT02608879|BG000|Baseline|OMDP Group|"Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.~Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.~Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth~Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol"
11257499|NCT02608879|BG001|Baseline|Control Group|"Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.~Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional."
11257500|NCT02608879|BG002|Baseline|Not Randomized|Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.
11257501|NCT02608879|BG003|Baseline|Total|Total of all reporting groups
11257502|NCT02608879|FG000|Participant Flow|OMDP Group|"Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.~Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.~Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth~Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol"
11257503|NCT02608879|FG001|Participant Flow|Control Group|"Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.~Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional."
11257504|NCT02608879|FG002|Participant Flow|Not Randomized|Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.
11257505|NCT02608879|OG000|Outcome|OMDP Group|"Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.~Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.~Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth~Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol"
11257506|NCT02608879|OG001|Outcome|Control Group|"Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.~Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional."
11257507|NCT02608879|OG000|Outcome|OMDP Group|Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
11257508|NCT02608879|EG000|Reported Event|OMDP Group|"Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.~Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.~Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth~Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol"
11257509|NCT02608879|EG001|Reported Event|Control Group|"Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.~Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional."
10848092|NCT00288509|FG000|Participant Flow|Dysport|250-1000 units
10848093|NCT00288509|OG000|Outcome|Dysport|250-1000 units
10848094|NCT00288509|EG000|Reported Event|Dysport|250-1000 units
10969944|NCT00908037|OG002|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
11213845|NCT02289417|OG000|Outcome|Extension Phase: Apremilast 30 mg|Participants who completed 52 weeks of treatment and had a Mayo endoscopy score ≤ 1 at week 52 were eligible to participate in the 52-week extension phase and received 30 mg apremilast BID for an additional 52 weeks. Includes participants assigned to 30 mg apremilast BID at week 12, and participants who entered the extension phase after implementation of Protocol Amendment 4.
11213846|NCT02289417|OG001|Outcome|Extension Phase: Apremilast 40 mg|Participants who completed 52 weeks of treatment and had a Mayo endoscopy score ≤ 1 at week 52 were eligible to participate in the 52-week extension phase and received 40 mg apremilast BID for an additional 52 weeks. After implementation of Protocol Amendment 4, participants were switched to 30 mg apremilast BID for the remainder of the extension phase.
11213847|NCT02289417|EG000|Reported Event|Placebo (Placebo Controlled Period)|TEAEs for participants who were randomized to identically matching placebo capsules twice a day (BID) for 12 weeks during the double-blind placebo-controlled phase.
11213848|NCT02289417|EG001|Reported Event|Apremilast 30 mg (Placebo Controlled Period)|TEAEs for participants who were randomized to apremilast 30 mg capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213849|NCT02289417|EG002|Reported Event|Apremilast 40 mg BID (Placebo Controlled Period)|TEAEs for participants who were randomized to apremilast 40 mg capsules PO BID for 12 weeks during the double-blind placebo-controlled phase.
11213850|NCT02289417|EG003|Reported Event|Apremilast 30 mg (Apremilast Exposure Period)|TEAEs during the apremilast 30 mg BID treatment for participants who received 30 mg apremilast capsules BID only and participants who initially received 30 mg apremilast capsules BID and switched to 40 mg apremilast capsules BID at Week 12, and participants who initially received placebo capsules BID and switched to 30 mg apremilast capsules BID at Week 12.
11213851|NCT02289417|EG004|Reported Event|Apremilast 40 mg (Apremilast Exposure Period)|TEAEs during the apremilast 40 mg BID treatment for participants who received 40 mg apremilast capsules BID only, and participants who initially received placebo BID and switched to 40 mg apremilast capsules BID at Week 12.
11213852|NCT02289417|EG005|Reported Event|Apremilast 30/40 mg (Apremilast Exposure Period)|TEAEs during the apremilast 40 mg BID treatment for participants who initially received 30 mg apremilast BID and switched to apremilast 40 mg BID at Week 12. for participants who initially received 30 mg apremilast dosage and switched to 40 mg apremilast capsules BID at Week 12.
11213853|NCT02289456|BG000|Baseline|(Induction Period) Nab-Paclitaxel and Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
11213854|NCT02289456|FG000|Participant Flow|Nab-Paclitaxel and Carboplatin|During the induction period, participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. In the absence of clinical or radiological disease progression, participants received monotherapy with nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
11213855|NCT02289456|OG000|Outcome|(Induction Period) Nab-Paclitaxel and Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
11213856|NCT02289456|OG000|Outcome|Nab-Paclitaxel/Carboplatin Followed by Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles during the Induction Period. In the absence of clinical or radiological disease progression, participants moved into the monotherapy period and received nab-paclitaxel 100 mg/m^2 by IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
11213857|NCT02289456|OG000|Outcome|Induction Period: Nab-Paclitaxel and/or Carboplatin|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle and carboplatin AUC of 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles.
11213858|NCT02289456|OG001|Outcome|Monotherapy Period: Nab-Paclitaxel|Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
11213859|NCT02289456|EG000|Reported Event|Induction: Nab-Paclitaxel/Carboplatin|Participant's received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle and barboplatin AUC = 5 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
11213860|NCT02289456|EG001|Reported Event|Monotherapy: Nab-Paclitaxel|Participants received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle
11213861|NCT02289456|EG002|Reported Event|Follow-Up Period|Participants who discontinued IP for any reason other than lost to follow-up, entered into a follow-up period; scans were performed based on standard of care. Anti-cancer treatments were collected and participants were followed for survival every 90 days for up to 1 year. Death during follow-up is defined as any death that is more than 28 days post last dose of study drug
11213862|NCT02289469|BG000|Baseline|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
11257510|NCT02608879|EG002|Reported Event|Not Randomized|Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.
11257511|NCT02608892|BG000|Baseline|Intervention Group|Viewed the BeSweet2Babies video.
11257512|NCT02608892|BG001|Baseline|Control Group|Received usual care.
11257513|NCT02608892|BG002|Baseline|Total|Total of all reporting groups
11257514|NCT02608892|FG000|Participant Flow|Intervention|"BSweet2Babies video~BSweet2Babies video: Mothers (and partners if possible) will view the brief BSweet2Babies video on electronic notebooks in French or English, as per parent/s' preference."
11257515|NCT02608892|FG001|Participant Flow|Control|Usual care
11257516|NCT02608892|OG000|Outcome|Intervention Group|Viewed the BeSweet2Babies video.
11257517|NCT02608892|OG001|Outcome|Control Group|Received usual care.
11257518|NCT02608892|OG000|Outcome|Intervention Group|Only those in the intervention group (who viewed the BeSweet2Babies video) were asked.
11257519|NCT02608892|EG000|Reported Event|Intervention Group|Viewed the BeSweet2Babies video.
11257520|NCT02608892|EG001|Reported Event|Control Group|Received usual care.
11257521|NCT02609100|BG000|Baseline|Video Capsule Endoscopy|"Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.~Video Capsule Endoscopy: Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.~1.0 X 2.5 cm 'pill' containing a camera"
11257522|NCT02609100|BG001|Baseline|Next Day Colonoscopy|"Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.~Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine."
11257523|NCT02609100|BG002|Baseline|Total|Total of all reporting groups
11257524|NCT02609100|FG000|Participant Flow|Video Capsule Endoscopy|Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
11257525|NCT02609100|FG001|Participant Flow|Next Day Colonoscopy|"Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.~Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine."
11257526|NCT02609100|OG000|Outcome|Video Capsule Endoscopy|Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
11257527|NCT02609100|OG000|Outcome|Next Day Colonoscopy|"Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.~Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine."
11257528|NCT02609100|OG000|Outcome|Video Capsule Endoscopy|"Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.~Video Capsule Endoscopy: Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.~1.0 X 2.5 cm 'pill' containing a camera"
11257529|NCT02609100|OG001|Outcome|Next Day Colonoscopy|"Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.~Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine."
11257530|NCT02609100|EG000|Reported Event|Video Capsule Endoscopy|Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
11257531|NCT02609100|EG001|Reported Event|Next Day Colonoscopy|"Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.~Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine."
11257532|NCT02609113|BG000|Baseline|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
11257533|NCT02609113|BG001|Baseline|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
11257534|NCT02609113|BG002|Baseline|Total|Total of all reporting groups
11257535|NCT02609113|FG000|Participant Flow|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
11257536|NCT02609113|FG001|Participant Flow|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
11257537|NCT02609113|OG000|Outcome|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
11257538|NCT02609113|OG001|Outcome|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
11257539|NCT02609113|EG000|Reported Event|Strong Magnetic Wristband|"Magnetic wristband of 1,795 Gauss strength~Strong Magnetic Wristband"
11257540|NCT02609113|EG001|Reported Event|Weaker Magnetic Wristband|"Magnetic wristband of 5 Gauss strength.~Weaker Magnetic Wristband"
11257541|NCT02609178|BG000|Baseline|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
11257542|NCT02609178|FG000|Participant Flow|FGP First, Then AVR, Then CON|Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.
11257543|NCT02609178|FG001|Participant Flow|FGP First, Then CON, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.
11257544|NCT02609178|FG002|Participant Flow|AVR First, Then FGP, Then CON|Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.
11257545|NCT02609178|FG003|Participant Flow|AVR First, Then CON, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.
11257546|NCT02609178|FG004|Participant Flow|CON First, Then FGP, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.
11257547|NCT02609178|FG005|Participant Flow|CON First, Then AVR, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
11257548|NCT02609178|OG000|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
11257549|NCT02609178|OG001|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
11257550|NCT02609178|OG002|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
11257551|NCT02609178|EG000|Reported Event|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
11257552|NCT02609204|BG000|Baseline|Healthy Controls|"51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.~Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules."
11257553|NCT02609204|FG000|Participant Flow|Healthy Controls|"51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA (Neuro Optic Vision Assessment).~Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules."
11257554|NCT02609204|OG000|Outcome|Healthy Controls|"51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.~Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules."
11257555|NCT02609204|OG000|Outcome|Healthy Controls|"51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.~Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA (Neuro Optic Vision Assessment) machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules."
11257556|NCT02609204|EG000|Reported Event|Healthy Controls|"51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.~Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules."
11257557|NCT02609308|BG000|Baseline|Short Leg Cast|"The patients in this group will be immobilize with a short leg cast for 14 days, and later they will be able to do physical rehabilitation and will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks."
11257558|NCT02609308|BG001|Baseline|Platelet-rich Plasma|"In this group, the patients will be receive a single dose of autologous platelet-rich plasma, and will be immobilized with a short leg cast. Posteriorly, they will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Platelet-rich plasma: Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament."
11257559|NCT02609308|BG002|Baseline|Total|Total of all reporting groups
11257560|NCT02609308|FG000|Participant Flow|Short Leg Cast|"The patients in this group will be immobilize with a short leg cast for 14 days, and later they will be able to do physical rehabilitation and will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks."
10848095|NCT00288574|BG000|Baseline|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
10848096|NCT00288574|BG001|Baseline|Placebo|Placebo group
10848097|NCT00288574|BG002|Baseline|Total|Total of all reporting groups
10848098|NCT00288574|FG000|Participant Flow|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
11257561|NCT02609308|FG001|Participant Flow|Platelet-rich Plasma|"In this group, the patients will be receive a single dose of autologous platelet-rich plasma, and will be immobilized with a short leg cast. Posteriorly, they will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Platelet-rich plasma: Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament."
11257562|NCT02609308|OG000|Outcome|Short Leg Cast|"The patients in this group will be immobilize with a short leg cast for 14 days, and later they will be able to do physical rehabilitation and will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks."
11257563|NCT02609308|OG001|Outcome|Platelet-rich Plasma|"In this group, the patients will be receive a single dose of autologous platelet-rich plasma, and will be immobilized with a short leg cast. Posteriorly, they will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Platelet-rich plasma: Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament."
11257564|NCT02609308|EG000|Reported Event|Short Leg Cast|"The patients in this group will be immobilize with a short leg cast for 14 days, and later they will be able to do physical rehabilitation and will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks."
11257565|NCT02609308|EG001|Reported Event|Platelet-rich Plasma|"In this group, the patients will be receive a single dose of autologous platelet-rich plasma, and will be immobilized with a short leg cast. Posteriorly, they will be evaluated with American Orthopedic Foot and Ankle Society's Ankle Hindfoot scale and Foot and Ankle Disability Index.~Platelet-rich plasma: Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament."
11257566|NCT02609399|BG000|Baseline|Experimental: Oseltamivir|Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
11257567|NCT02609399|BG001|Baseline|Experimental: Peramivir|Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir.
11257568|NCT02609399|BG002|Baseline|Total|Total of all reporting groups
11257569|NCT02609399|FG000|Participant Flow|Oseltamivir|Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
11257570|NCT02609399|FG001|Participant Flow|Peramivir|Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
11257571|NCT02609399|OG000|Outcome|Oseltamivir|Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
11257572|NCT02609399|OG001|Outcome|Peramivir|Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
11257573|NCT02609399|OG000|Outcome|Experimental: Oseltamivir|Subjects randomized to the oral treatment arm received 5 days of oral oseltamivir.
11257574|NCT02609399|OG001|Outcome|Experimental: Peramivir|Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
11257575|NCT02609399|EG000|Reported Event|Oseltamivir|"Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.~Oseltamivir: Oral"
11257576|NCT02609399|EG001|Reported Event|Peramivir|"Subjects randomized to the IV treatment group will receive 1 dose (or more as appropriate at the discretion of the treating physician) of IV peramivir.~Peramivir: IV~Note: Should a patient remain in the hospital after 5 days of treatment, and the patient is symptomatically better, treatment will stop. If the patient remains hospitalized after 5 days of treatment and has not improved, the treating physician will continue to have an option to continue use of peramivir daily for another 5 day course."
11257577|NCT02609607|BG000|Baseline|Placebo|"Every other day placement of a placebo rectal suppository for 4 weeks~Placebo: Rectal suppository"
11257578|NCT02609607|BG001|Baseline|Bisacodyl|"Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks~Bisacodyl: Rectal suppository"
11257579|NCT02609607|BG002|Baseline|Total|Total of all reporting groups
11257580|NCT02609607|FG000|Participant Flow|Placebo|"Every other day placement of a placebo rectal suppository for 4 weeks~Placebo: Rectal suppository"
11257581|NCT02609607|FG001|Participant Flow|Bisacodyl|"Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks~Bisacodyl: Rectal suppository"
11257582|NCT02609607|OG000|Outcome|Placebo|"Every other day placement of a placebo rectal suppository for 4 weeks~Placebo: Rectal suppository"
11257583|NCT02609607|OG001|Outcome|Bisacodyl|"Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks~Bisacodyl: Rectal suppository"
11257584|NCT02609607|EG000|Reported Event|Placebo|"Every other day placement of a placebo rectal suppository for 4 weeks~Placebo: Rectal suppository"
11257585|NCT02609607|EG001|Reported Event|Bisacodyl|"Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks~Bisacodyl: Rectal suppository"
11257586|NCT02609633|BG000|Baseline|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
11257587|NCT02609633|BG001|Baseline|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
11257588|NCT02609633|BG002|Baseline|Total|Total of all reporting groups
11257589|NCT02609633|FG000|Participant Flow|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
10848099|NCT00288574|FG001|Participant Flow|Placebo|Placebo group
10848100|NCT00288574|OG000|Outcome|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
10848101|NCT00288574|OG001|Outcome|Placebo|Placebo group
10848102|NCT00288574|OG000|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
10848103|NCT00288574|OG001|Outcome|Placebo|Placebo
10848104|NCT00288574|OG001|Outcome|Placebo|placebo to match fluoxetine
11257590|NCT02609633|FG001|Participant Flow|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
11257591|NCT02609633|OG000|Outcome|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
11257592|NCT02609633|OG001|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
11257593|NCT02609633|OG000|Outcome|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
11257594|NCT02609633|EG000|Reported Event|Control: Usual Care - Current Diabetes Management System (DMS)|Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
11257595|NCT02609633|EG001|Reported Event|Interventional: Accu-Chek® CONNECT DMS|Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
11257596|NCT02609659|BG000|Baseline|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
11257597|NCT02609659|FG000|Participant Flow|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
11257598|NCT02609659|OG000|Outcome|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
11257599|NCT02609659|EG000|Reported Event|3-DAA + RBV 600 mg|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
11257600|NCT02609672|BG000|Baseline|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257601|NCT02609672|BG001|Baseline|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257602|NCT02609672|BG002|Baseline|Total|Total of all reporting groups
11257603|NCT02609672|FG000|Participant Flow|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257604|NCT02609672|FG001|Participant Flow|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11337405|NCT03583606|FG001|Participant Flow|ChAd3-EBO-Z + ChAd3-EBO-Z|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10^11 vp) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp))."
11337406|NCT03583606|FG002|Participant Flow|ChAd3-EBO-Z + MVA- BN-Filo|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).~MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10^8 Infectious Units (IU)."
10848105|NCT00288574|EG000|Reported Event|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
10848106|NCT00288574|EG001|Reported Event|Placebo|Placebo Medication
10848107|NCT00288587|BG000|Baseline|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
10848108|NCT00288587|BG001|Baseline|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
10848109|NCT00288587|BG002|Baseline|Total|Total of all reporting groups
10848110|NCT00288587|FG000|Participant Flow|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
11213863|NCT02289469|BG001|Baseline|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
11213864|NCT02289469|BG002|Baseline|Total|Total of all reporting groups
11213865|NCT02289469|FG000|Participant Flow|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
11213866|NCT02289469|FG001|Participant Flow|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
11213867|NCT02289469|OG000|Outcome|PictureRx|"PictureRx medication history platform~PictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history"
11213868|NCT02289469|OG001|Outcome|Usual Care|Usual medication history process
11213869|NCT02289469|EG000|Reported Event|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
11213870|NCT02289469|EG001|Reported Event|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
11213871|NCT02289690|BG000|Baseline|Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 80 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213872|NCT02289690|BG001|Baseline|Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213873|NCT02289690|BG002|Baseline|Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease pParticipants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213874|NCT02289690|BG003|Baseline|Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213875|NCT02289690|BG004|Baseline|Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213876|NCT02289690|BG005|Baseline|Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213877|NCT02289690|BG006|Baseline|Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213878|NCT02289690|BG007|Baseline|Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11257605|NCT02609672|OG000|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257606|NCT02609672|OG001|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257607|NCT02609672|EG000|Reported Event|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257608|NCT02609672|EG001|Reported Event|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11257609|NCT02609841|BG000|Baseline|<3 K Dialysate Patients|Patients on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
11257610|NCT02609841|BG001|Baseline|≥3K Dialysate Patients|Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days
11257611|NCT02609841|BG002|Baseline|Total|Total of all reporting groups
11257612|NCT02609841|FG000|Participant Flow|Enrolled Study Population|All patients who were enrolled in the study
11257613|NCT02609841|OG000|Outcome|<3 K Dialysate Patients|Subjects on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
11257614|NCT02609841|OG000|Outcome|≥3 K Dialysate Patients|Subjects on ≥3 K dialysate and received all 6 hemodialysis treatments over 12 days.
11257615|NCT02609841|OG000|Outcome|Completed the Study and Wore the Body Guardian|All subjects (<3 K dialysate or dialysate combined) who received all 6 hemodialysis treatments over 12 days and wore the Body Guardian device
11257616|NCT02609841|EG000|Reported Event|Cardiac Rhythm Monitoring System|Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
11257617|NCT02609984|BG000|Baseline|CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab|Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.
11257618|NCT02609984|BG001|Baseline|Atezolizumab|Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
11257619|NCT02609984|BG002|Baseline|Total|Total of all reporting groups
11257620|NCT02609984|FG000|Participant Flow|CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab|Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered intradermally (ID) on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered intramuscularly (IM) and LV305. LV305 was administered at a dose of 1×10^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of New York Esophageal Squamous Cell Carcinoma 1 (NY ESO-1) protein.
11257621|NCT02609984|FG001|Participant Flow|Atezolizumab|Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
11257622|NCT02609984|OG000|Outcome|CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab|Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.
11257623|NCT02609984|OG001|Outcome|Atezolizumab|Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
11257624|NCT02609984|EG000|Reported Event|CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab|Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.
11257625|NCT02609984|EG001|Reported Event|Atezolizumab|Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
11257626|NCT02610140|BG000|Baseline|Anetumab Ravtansine (Experimental)|Experimental
11257627|NCT02610140|BG001|Baseline|Vinorelbine (Active Comparator)|Active comparator
11257628|NCT02610140|BG002|Baseline|Total|Total of all reporting groups
11257629|NCT02610140|FG000|Participant Flow|Anetumab Ravtansine (Experimental)|Experimental
11257630|NCT02610140|FG001|Participant Flow|Vinorelbine (Active Comparator)|Active comparator
11257631|NCT02610140|OG000|Outcome|Anetumab Ravtansine|Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
11257632|NCT02610140|OG001|Outcome|Vinorelbine|Active comparator: 30 mg/m^2 once weekly
11257633|NCT02610140|EG000|Reported Event|Anetumab Ravtansine (BAY94-9343)|Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
11257634|NCT02610140|EG001|Reported Event|Vinorelbine|Active comparator: 30 mg/m^2 once weekly
11257635|NCT02610192|BG000|Baseline|nSTRIDE APS|Intra-articular Injection of Autologous Protein Solution (APS)
11257636|NCT02610192|FG000|Participant Flow|nSTRIDE APS|Intra-articular Injection of Autologous Protein Solution (APS)
11257637|NCT02610192|OG000|Outcome|nSTRIDE APS|Intra-articular Injection of Autologous Protein Solution (APS)
11257638|NCT02610192|EG000|Reported Event|nSTRIDE APS|Intra-articular Injection of Autologous Protein Solution (APS)
11257639|NCT02610231|BG000|Baseline|Istradefylline 20 mg or 40 mg|"Treatment for 52 weeks~Istradefylline 20 mg or 40 mg"
11257640|NCT02610231|FG000|Participant Flow|Istradefylline 20 mg or 40mg|Eligible subjects were treated with istradefylline at a starting dose of 20mg/d with an option for dose adjustment at week 40mg/d at week 12 based on the Investigator's judgement of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between weeks 2 and 12 was allowed in accordance with the Investigator's clinical judgement. Subjects who had a dose adjustment to 40 mg/d could have their dose decreased to 20mg/d by the investigator at a second unscheduled dose adjustment visit if there were tolerability issues. The istradefylline dose was to remain fixed between Weeks 26 and weeks 52. Subjects took one tablet orally in the morning
11257641|NCT02610231|OG000|Outcome|Safety Analysis Set|Open label treatment for 52 weeks with Istradefylline 20 mg or 40 mg
11257642|NCT02610231|OG000|Outcome|Efficacy Analysis Based on PGI-I Scores at Week 12.|The percentage of subjects showing improvement (moderate or mild) on PGI-I scores at (week 12).
11257643|NCT02610231|OG001|Outcome|Efficacy Analysis Based on PGI-I Scores at Week 26.|The percentage of subjects showing improvement (moderate or mild) on PGI-I scores at (week 26).
11257644|NCT02610231|OG002|Outcome|Efficacy Analysis Based on PGI-I Scores at Week 52.|The percentage of subjects showing improvement (moderate or mild) on PGI-I scores at (week 52).
11257645|NCT02610231|EG000|Reported Event|Istradefylline 20 mg or 40 mg|"Treatment for 52 weeks~Istradefylline 20 mg or 40 mg"
10820316|NCT00056550|FG000|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80% and <120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments were based on the results of AT activity level determinations performed prior to and during the treatment.
11257646|NCT02610634|BG000|Baseline|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
11257647|NCT02610634|BG001|Baseline|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
11257648|NCT02610634|BG002|Baseline|Total|Total of all reporting groups
11257649|NCT02610634|FG000|Participant Flow|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
11257650|NCT02610634|FG001|Participant Flow|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
11257651|NCT02610634|OG000|Outcome|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
11257652|NCT02610634|OG001|Outcome|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
11257653|NCT02610634|EG000|Reported Event|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
11257654|NCT02610634|EG001|Reported Event|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
11257655|NCT02610725|BG000|Baseline|Yoga Class|"A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires.~Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with."
11257656|NCT02610725|FG000|Participant Flow|Yoga Class|"A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires.~Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with."
11257657|NCT02610725|OG000|Outcome|Yoga Class|"A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires.~Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with."
11257658|NCT02610725|EG000|Reported Event|Yoga Class|"A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires.~Hatha yoga: Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with."
11257659|NCT02610816|BG000|Baseline|1FED|1-food elimination diet: participants eliminate milk from the diet for 12 weeks
11257660|NCT02610816|BG001|Baseline|4FED|4-food elimination diet: participants eliminate milk, egg, wheat, soy from the diet for 12 weeks
11257661|NCT02610816|BG002|Baseline|Total|Total of all reporting groups
11257662|NCT02610816|FG000|Participant Flow|1FED|1-food elimination diet: participants eliminate milk from the diet for 12 weeks
11257663|NCT02610816|FG001|Participant Flow|4FED|4-food elimination diet: participants eliminate milk, egg, wheat, soy from the diet for 12 weeks
11257664|NCT02610816|FG002|Participant Flow|1FED Non-responders (4FED)|Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in phase 2
11257665|NCT02610816|FG003|Participant Flow|4FED Non-responders (SGC)|Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in phase 2
11257666|NCT02610816|OG000|Outcome|1FED|1-food elimination diet: participants eliminate milk from the diet for 12 weeks
11257667|NCT02610816|OG001|Outcome|4FED|4-food elimination diet: participants eliminate milk, egg, wheat, soy from the diet for 12 weeks
11257668|NCT02610816|OG000|Outcome|4FED Non-responders (SGC)|Participants that fail to respond to 4FED in Phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2
11257669|NCT02610816|OG000|Outcome|1FED Non-responders (4FED)|Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in phase 2
11257670|NCT02610816|EG000|Reported Event|1FED|1-food elimination diet (Phase 1)
11257671|NCT02610816|EG001|Reported Event|4FED|4-food elimination diet (Phase 1)
11257672|NCT02610816|EG002|Reported Event|1FED Non-responders (4FED)|4-food elimination diet (Phase 2)
11257673|NCT02610816|EG003|Reported Event|4FED Non-responders (SGC)|Swallowed glucocorticosteroids (Flovent HFA) (Phase 2)
11257674|NCT02610842|BG000|Baseline|Handbook Group|Patients with systemic scleroderma and hands commitment.
11257675|NCT02610842|FG000|Participant Flow|Handbook Group|"Patients will receive a home based program named Hands on - a hand care guide in Systemic Sclerosis which includes a handbook with instructions about the disease and hand exercises. Patients will be asked to follow the program instructions and carry out the exercises daily during the following 12 weeks.~Handbook: The handbook named Hands on - a hand care guide in Systemic Sclerosis contains instructions about the Systemic Sclerosis and hand exercises."
11257676|NCT02610842|OG000|Outcome|Handbook Group|Systemic Scleroderma subjects
11257677|NCT02610842|OG000|Outcome|Handbook Group|Systemic Sclerosis subjects
11257678|NCT02610842|OG000|Outcome|Handbook Group|Systemic sclerosis subjects
11257679|NCT02610842|EG000|Reported Event|Handbook Group|Systemic Scleroderma subjects
11257680|NCT02610868|BG000|Baseline|MYOBLOC|"MYOBLOC: After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1; Weeks 4, 13 for Treatment Sessions 2-4.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257681|NCT02610868|FG000|Participant Flow|MYOBLOC: 3500U|After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments.
11257682|NCT02610868|OG000|Outcome|Treatment Session 1|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.
11257683|NCT02610868|OG001|Outcome|Treatment Session 2|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.
11257684|NCT02610868|OG002|Outcome|Treatment Session 3|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.
11257685|NCT02610868|OG003|Outcome|Treatment Session 4|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.
11257686|NCT02610868|OG000|Outcome|Treatment Session 1: Week 4|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.
11257687|NCT02610868|OG001|Outcome|Treatment Session 1: Week 8|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.
11257688|NCT02610868|OG002|Outcome|Treatment Session 1: Week 13|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.
11257689|NCT02610868|OG003|Outcome|Treatment Session 2: Week 4|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.
11257690|NCT02610868|OG004|Outcome|Treatment Session 2: Week 13|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.
11257691|NCT02610868|OG005|Outcome|Treatment Session 3: Week 4|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.
11257692|NCT02610868|OG006|Outcome|Treatment Session 3: Week 13|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.
11257693|NCT02610868|OG007|Outcome|Treatment Session 4: Week 4|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
11257694|NCT02610868|OG008|Outcome|Treatment Session 4: Week 13|Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
11257695|NCT02610868|EG000|Reported Event|MYOBLOC: Treatment Session 1|"After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257696|NCT02610868|EG001|Reported Event|MYOBLOC: Treatment Session 2|"After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257697|NCT02610868|EG002|Reported Event|MYOBLOC: Treatment Session 3|"After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257698|NCT02610868|EG003|Reported Event|MYOBLOC: Treatment Session 4|"After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257699|NCT02610868|EG004|Reported Event|ALL MYOBLOC: Treatment Sessions 1-4|"After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1, Weeks 4 and 13 for Treatment Sessions 2-4.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."
11257700|NCT02610972|BG000|Baseline|CLINICALLY CONFIRMED PREECLAMPSIA|"Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257701|NCT02610972|BG001|Baseline|CLINICALLY HEALTHY|"Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257702|NCT02610972|BG002|Baseline|Total|Total of all reporting groups
11257703|NCT02610972|FG000|Participant Flow|CLINICALLY CONFIRMED PREECLAMPSIA|"Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257704|NCT02610972|FG001|Participant Flow|CLINICALLY HEALTHY|"Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
10820317|NCT00056550|OG000|Outcome|Recombinant Human Antithombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin (AT) deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80 and < 120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
11257705|NCT02610972|OG000|Outcome|CLINICALLY CONFIRMED PREECLAMPSIA|"Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257706|NCT02610972|OG001|Outcome|CLINICALLY HEALTHY|"Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257707|NCT02610972|EG000|Reported Event|CLINICALLY CONFIRMED PREECLAMPSIA|"Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11257708|NCT02610972|EG001|Reported Event|CLINICALLY HEALTHY|"Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.~Congo Red test GV-005: Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine."
11337407|NCT03583606|OG000|Outcome|ChAd3-EBO-Z + Placebo|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
11337408|NCT03583606|OG001|Outcome|ChAd3-EBO-Z + ChAd3-EBO-Z|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10^11 vp) intramuscularly into the opposite arm on Day 8.
11257709|NCT02611154|BG000|Baseline|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
11257710|NCT02611154|FG000|Participant Flow|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
11257711|NCT02611154|OG000|Outcome|Urine Steroid Profile - Day 6|Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
11257712|NCT02611154|OG001|Outcome|Urine Steroid Profile - Day 13|Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
11257713|NCT02611154|OG002|Outcome|Urine Steroid Profile - Day 21|Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
11257714|NCT02611154|OG003|Outcome|Urine Steroid Profile - Day 28|Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
11257715|NCT02611154|OG004|Outcome|Urine Steroid Profile - Day 29|Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.
11257716|NCT02611154|OG005|Outcome|Urine Steroid Profile - Day 30|Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.
11257717|NCT02611154|OG006|Outcome|Urine Steroid Profile - Day 35|Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.
11257718|NCT02611154|OG007|Outcome|Urine Steroid Profile - Day 42|Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
11257719|NCT02611154|OG000|Outcome|Testosterone|Testosterone level will be measured in the urine sample.
11257720|NCT02611154|OG001|Outcome|Epitestosterone|Epitestosterone level will be measured in the urine sample.
11257721|NCT02611154|OG002|Outcome|Androsterone|Androsterone level will be measured in the urine sample.
11257722|NCT02611154|OG003|Outcome|Etiocholanolone|Etiocholanolone level will be measured in the urine sample.
11257723|NCT02611154|OG004|Outcome|5αAdiol|5αAdiol level will be measured in the urine sample.
11257724|NCT02611154|OG005|Outcome|5βAdiol|5βAdiol level will be measured in the urine sample.
11257725|NCT02611154|OG000|Outcome|Serum Testosterone - Day 0|Serum Testosterone at Day 0
11257726|NCT02611154|OG001|Outcome|Serum Testosterone - Day 19|Serum Testosterone at Day 19
11257727|NCT02611154|EG000|Reported Event|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
11257728|NCT02611362|BG000|Baseline|Intervention|"The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as Missing you: Get in the Game to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.~IMB Gaming Intervention"
11257729|NCT02611362|BG001|Baseline|Comparison|This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
11257730|NCT02611362|BG002|Baseline|Total|Total of all reporting groups
11257731|NCT02611362|FG000|Participant Flow|Intervention|"Subjects in the intervention group will each receive smartphones with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as Missing you: Get in the Game to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.~IMB Gaming Intervention"
11257732|NCT02611362|FG001|Participant Flow|Comparison|This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
10848111|NCT00288587|FG001|Participant Flow|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
11257733|NCT02611362|OG000|Outcome|Intervention|"Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as Missing you: Get in the Game to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.~IMB Gaming Intervention"
11257734|NCT02611362|OG001|Outcome|Comparison|This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
11257735|NCT02611362|OG000|Outcome|Intervention|"Subjects in the intervention will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as Missing you: Get in the Game to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.~IMB Gaming Intervention"
11257736|NCT02611362|EG000|Reported Event|Intervention|"The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as Missing you: Get in the Game to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.~IMB Gaming Intervention"
11257737|NCT02611362|EG001|Reported Event|Comparison|This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
11257738|NCT02611479|BG000|Baseline|Spine Fusion Participants|Patients undergoing lumbar spine fusion surgery for any indication.
11257739|NCT02611479|FG000|Participant Flow|Spine Fusion Participants|Patients undergoing lumbar spine fusion surgery for any indication.
11257740|NCT02611479|OG000|Outcome|Spine Fusion Participants|Patients undergoing lumbar spine fusion surgery for any indication.
11257741|NCT02611479|EG000|Reported Event|Spine Fusion Participants|Patients undergoing lumbar spine fusion surgery for any indication.
11257742|NCT02611752|BG000|Baseline|CAM2038 q1w, 24 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13.
11257743|NCT02611752|BG001|Baseline|CAM2038 q1w, 32 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13.
11257744|NCT02611752|BG002|Baseline|Total|Total of all reporting groups
11257745|NCT02611752|FG000|Participant Flow|CAM2038 q1w, 24 mg|CAM2038 once weekly 24 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
11257746|NCT02611752|FG001|Participant Flow|CAM2038 q1w, 32 mg|CAM2038 once weekly 32 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
11257747|NCT02611752|OG000|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 0 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257748|NCT02611752|OG001|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 6 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257749|NCT02611752|OG002|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 18 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257750|NCT02611752|OG000|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 0 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
10820318|NCT00056550|OG000|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
11257751|NCT02611752|OG001|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 6 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257752|NCT02611752|OG002|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 18 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257753|NCT02611752|OG000|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) and 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257754|NCT02611752|OG001|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 0mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 0 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
11257755|NCT02611752|OG002|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 6 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
11257756|NCT02611752|OG000|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) and 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
11257757|NCT02611752|OG001|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 0mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 0 mg intramuscular injection will be administered on 2 of the 3 days during baseline and4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257758|NCT02611752|OG002|Outcome|CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 6 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257759|NCT02611752|OG000|Outcome|CAM2038 q1w, 24 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
11257760|NCT02611752|OG001|Outcome|CAM2038 q1w, 32 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
11257761|NCT02611752|OG000|Outcome|CAM2038 q1w, 24 mg - Hydromorphone 0 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257762|NCT02611752|EG000|Reported Event|CAM2038 q1w, 24 mg|CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257763|NCT02611752|EG001|Reported Event|CAM2038 q1w, 32 mg|CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
11257764|NCT02611765|BG000|Baseline|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
11257765|NCT02611765|BG001|Baseline|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
11257766|NCT02611765|BG002|Baseline|Total|Total of all reporting groups
11257767|NCT02611765|FG000|Participant Flow|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
11257768|NCT02611765|FG001|Participant Flow|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
11257769|NCT02611765|OG000|Outcome|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
11257770|NCT02611765|OG001|Outcome|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
11257771|NCT02611765|EG000|Reported Event|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
11257772|NCT02611765|EG001|Reported Event|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
11257773|NCT02611778|BG000|Baseline|FYB201|Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
10820319|NCT00056550|EG000|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
11213879|NCT02289690|BG008|Baseline|Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213880|NCT02289690|BG009|Baseline|Phase 2: Placebo + Carboplatin/Etoposide -> Placebo|"Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213881|NCT02289690|BG010|Baseline|Total|Total of all reporting groups
11213882|NCT02289690|FG000|Participant Flow|Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213883|NCT02289690|FG001|Participant Flow|Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213884|NCT02289690|FG002|Participant Flow|Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213885|NCT02289690|FG003|Participant Flow|Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213886|NCT02289690|FG004|Participant Flow|Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213887|NCT02289690|FG005|Participant Flow|Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213888|NCT02289690|FG006|Participant Flow|Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213889|NCT02289690|FG007|Participant Flow|Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213890|NCT02289690|FG008|Participant Flow|Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213891|NCT02289690|FG009|Participant Flow|Phase 2: Placebo + Carboplatin/Etoposide -> Placebo|"Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11257774|NCT02611778|BG001|Baseline|Lucentis|Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257775|NCT02611778|BG002|Baseline|Total|Total of all reporting groups
11257776|NCT02611778|FG000|Participant Flow|FYB201|Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257777|NCT02611778|FG001|Participant Flow|Lucentis|Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257778|NCT02611778|OG000|Outcome|FYB201|Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257779|NCT02611778|OG001|Outcome|Lucentis|Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257780|NCT02611778|OG002|Outcome|Total|Total of all reporting groups
11257781|NCT02611778|EG000|Reported Event|FYB201|Patients received FYB201 at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257782|NCT02611778|EG001|Reported Event|Lucentis|Patients received Lucentis (ranibizumab) at a dose of 0.5mg (0.05mL of a 10mg/mL solution) as twelve monthly intravitreal injections
11257783|NCT02611882|BG000|Baseline|High-risk Prostate Cancer Pre-prostatectomy (preRP) Population|"Patients with high-risk prostate cancer pre-prostatectomy.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257784|NCT02611882|BG001|Baseline|Biochemical Recurrence (BCR) Population|"Patients with prostate cancer with biochemical recurrence.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257785|NCT02611882|BG002|Baseline|Castrate Resistant Prostate Cancer (CRCP) Population|"Patients with castrate resistant prostate cancer.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257786|NCT02611882|BG003|Baseline|Total|Total of all reporting groups
11257787|NCT02611882|FG000|Participant Flow|High-risk Prostate Cancer Pre-prostatectomy (preRP) Population|"Patients with high-risk prostate cancer pre-prostatectomy.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257788|NCT02611882|FG001|Participant Flow|Biochemical Recurrence (BCR) Population|"Patients with prostate cancer with biochemical recurrence.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257789|NCT02611882|FG002|Participant Flow|Castrate Resistant Prostate Cancer (CRCP) Population|Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
11257790|NCT02611882|OG000|Outcome|High-risk Prostate Cancer Pre-prostatectomy (preRP) Population|"Patients with high-risk prostate cancer pre-prostatectomy.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257791|NCT02611882|OG001|Outcome|Biochemical Recurrence (BCR) Population|"Patients with prostate cancer with biochemical recurrence.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257792|NCT02611882|OG000|Outcome|Biochemical Recurrence (BCR) Population|"Patients with prostate cancer with biochemical recurrence.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257793|NCT02611882|EG000|Reported Event|High-risk Prostate Cancer Pre-prostatectomy (preRP) Population|"Patients with high-risk prostate cancer pre-prostatectomy.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257794|NCT02611882|EG001|Reported Event|Biochemical Recurrence (BCR) Population|"Patients with prostate cancer with biochemical recurrence.~Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later."
11257795|NCT02612064|BG000|Baseline|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11257796|NCT02612064|BG001|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
11257797|NCT02612064|BG002|Baseline|Total|Total of all reporting groups
11257798|NCT02612064|FG000|Participant Flow|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11257799|NCT02612064|FG001|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
11337409|NCT03583606|OG002|Outcome|ChAd3-EBO-Z + MVA- BN-Filo|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
11337410|NCT03583606|OG002|Outcome|ChAd3-EBO-Z + MVABN-Filo|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
11257800|NCT02612064|OG000|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11257801|NCT02612064|OG001|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
11257802|NCT02612064|EG000|Reported Event|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11257803|NCT02612064|EG001|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
11257804|NCT02612077|BG000|Baseline|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
11257805|NCT02612077|FG000|Participant Flow|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
11257806|NCT02612077|OG000|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
11257807|NCT02612077|OG001|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
11257808|NCT02612077|OG002|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
11257809|NCT02612077|OG000|Outcome|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
11257810|NCT02612077|EG000|Reported Event|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
11257811|NCT02612155|BG000|Baseline|Intervention Cell Recipients|"Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Infusion of autologous cord blood: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells."
11257812|NCT02612155|BG001|Baseline|Placebo Recipients|"Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Placebo: Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit."
11257813|NCT02612155|BG002|Baseline|Total|Total of all reporting groups
11257814|NCT02612155|FG000|Participant Flow|Intervention Cell Recipients|"Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Infusion of autologous cord blood: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells."
11257815|NCT02612155|FG001|Participant Flow|Placebo Recipients|"Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Placebo: Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit."
11257816|NCT02612155|OG000|Outcome|Intervention Cell Recipients|"Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Infusion of autologous cord blood: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells."
11257817|NCT02612155|OG001|Outcome|Placebo Recipients|"Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Placebo: Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit."
11257818|NCT02612155|EG000|Reported Event|Intervention Cell Recipients|"Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Infusion of autologous cord blood: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells."
11257819|NCT02612155|EG001|Reported Event|Placebo Recipients|"Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment~Placebo: Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit."
11257820|NCT02612428|BG000|Baseline|ELAD System|"This group will receive treatment with ELAD plus standard of care therapy.~ELAD System: An extracorporeal human hepatic cell-based liver treatment"
11257821|NCT02612428|BG001|Baseline|Standard of Care (Control)|"This group will receive standard of care therapy as defined in the protocol.~Standard of Care (Control): Standard medical treatment as defined by the protocol"
11257822|NCT02612428|BG002|Baseline|Total|Total of all reporting groups
11257823|NCT02612428|FG000|Participant Flow|ELAD System|"This group will receive treatment with ELAD plus standard of care therapy.~ELAD System: An extracorporeal human hepatic cell-based liver treatment"
11257824|NCT02612428|FG001|Participant Flow|Standard of Care (Control)|"This group will receive standard of care therapy as defined in the protocol.~Standard of Care (Control): Standard medical treatment as defined by the protocol"
11257825|NCT02612428|OG000|Outcome|ELAD System|"This group will receive treatment with ELAD plus standard of care therapy.~ELAD System: An extracorporeal human hepatic cell-based liver treatment"
11257826|NCT02612428|OG001|Outcome|Standard of Care (Control)|"This group will receive standard of care therapy as defined in the protocol.~Standard of Care (Control): Standard medical treatment as defined by the protocol"
11257827|NCT02612428|EG000|Reported Event|ELAD System|"This group will receive treatment with ELAD plus standard of care therapy.~ELAD System: An extracorporeal human hepatic cell-based liver treatment"
11257828|NCT02612428|EG001|Reported Event|Standard of Care (Control)|"This group will receive standard of care therapy as defined in the protocol.~Standard of Care (Control): Standard medical treatment as defined by the protocol"
11257829|NCT02612610|BG000|Baseline|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
11257830|NCT02612610|BG001|Baseline|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257831|NCT02612610|BG002|Baseline|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257832|NCT02612610|BG003|Baseline|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257833|NCT02612610|BG004|Baseline|Total|Total of all reporting groups
11257834|NCT02612610|FG000|Participant Flow|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
11257835|NCT02612610|FG001|Participant Flow|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257836|NCT02612610|FG002|Participant Flow|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257837|NCT02612610|FG003|Participant Flow|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257838|NCT02612610|OG000|Outcome|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
11257839|NCT02612610|OG001|Outcome|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257840|NCT02612610|OG002|Outcome|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257841|NCT02612610|OG003|Outcome|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257842|NCT02612610|EG000|Reported Event|Placebo|Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
11257843|NCT02612610|EG001|Reported Event|Gefapixant 7.5 mg|Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257844|NCT02612610|EG002|Reported Event|Gefapixant 20 mg|Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257845|NCT02612610|EG003|Reported Event|Gefapixant 50 mg|Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
11257846|NCT02612623|BG000|Baseline|Gefapixant 15 mg Twice Daily|Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257847|NCT02612623|BG001|Baseline|Gefapixant 30 mg Twice Daily|Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257848|NCT02612623|BG002|Baseline|Gefapixant 50 mg Twice Daily|One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
11257849|NCT02612623|BG003|Baseline|Placebo to Match Gefapixant|Matching placebo tablets administered by mouth twice daily for 8 weeks
11257850|NCT02612623|BG004|Baseline|Total|Total of all reporting groups
11257851|NCT02612623|FG000|Participant Flow|Gefapixant 15 mg Twice Daily|Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257852|NCT02612623|FG001|Participant Flow|Gefapixant 30 mg Twice Daily|Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257853|NCT02612623|FG002|Participant Flow|Gefapixant 50 mg Twice Daily|One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
11257854|NCT02612623|FG003|Participant Flow|Placebo to Match Gefapixant|Matching placebo tablets administered by mouth twice daily for 8 weeks
11257855|NCT02612623|OG000|Outcome|Gefapixant 15 mg Twice Daily|Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257856|NCT02612623|OG001|Outcome|Gefapixant 30 mg Twice Daily|Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257857|NCT02612623|OG002|Outcome|Gefapixant 50 mg Twice Daily|One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
11257858|NCT02612623|OG003|Outcome|Placebo to Match Gefapixant|Matching placebo tablets administered by mouth twice daily for 8 weeks
11257859|NCT02612623|EG000|Reported Event|Placebo|Matching placebo tablets administered by mouth twice daily for 8 weeks
11257860|NCT02612623|EG001|Reported Event|Gefapixant 15 mg|Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257861|NCT02612623|EG002|Reported Event|Gefapixant 30 mg|Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
11257862|NCT02612623|EG003|Reported Event|Gefapixant 50 mg|One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
11257863|NCT02612688|BG000|Baseline|Advance Care Planning (ACP) Video Program|"Facility asked to implement Advance Care Planning (ACP) Video Program~ACP Video Program: The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting)."
11257864|NCT02612688|BG001|Baseline|Usual Advance Care Planning (ACP) Procedures|Facility follows usual Advance Care Planning (ACP) procedures
11257865|NCT02612688|BG002|Baseline|Total|Total of all reporting groups
11257866|NCT02612688|FG000|Participant Flow|ACP Video Program|"Facility asked to implement ACP Video Program~ACP Video Program: The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting)."
11257867|NCT02612688|FG001|Participant Flow|Usual ACP Procedures|Facility follows usual ACP procedures
11257868|NCT02612688|OG000|Outcome|ACP Video Program|"Facility asked to implement ACP Video Program~ACP Video Program: The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting)."
11257869|NCT02612688|OG001|Outcome|Usual ACP Procedures|Facility follows usual ACP procedures
11257870|NCT02612688|OG000|Outcome|Advance Care Planning (ACP) Video Program|"Facility asked to implement Advance Care Planning (ACP) Video Program~ACP Video Program: The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting)."
11257871|NCT02612688|OG001|Outcome|Usual Advance Care Planning (ACP) Procedures|Facility follows usual Advance Care Planning (ACP) procedures
11257872|NCT02612688|EG000|Reported Event|ACP Video Program|"Facility asked to implement ACP Video Program~ACP Video Program: The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting)."
11257873|NCT02612688|EG001|Reported Event|Usual ACP Procedures|Facility follows usual ACP procedures
11257874|NCT02612727|BG000|Baseline|Filtered-sunlight Phototherapy|"Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.~Filtered-sunlight phototherapy: Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film."
11257875|NCT02612727|BG001|Baseline|Intensive Phototherapy|"Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.~Intensive phototherapy: Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days."
11257876|NCT02612727|BG002|Baseline|Total|Total of all reporting groups
11257877|NCT02612727|FG000|Participant Flow|Filtered-sunlight Phototherapy|"Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.~Filtered-sunlight phototherapy: Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film."
11257878|NCT02612727|FG001|Participant Flow|Intensive Phototherapy|"Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.~Intensive phototherapy: Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days."
11257879|NCT02612727|OG000|Outcome|Filtered-sunlight Phototherapy|"Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.~Filtered-sunlight phototherapy: Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film."
11257880|NCT02612727|OG001|Outcome|Intensive Phototherapy|"Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.~Intensive phototherapy: Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days."
11257881|NCT02612727|EG000|Reported Event|Filtered-sunlight Phototherapy|"Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.~Filtered-sunlight phototherapy: Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film."
11257882|NCT02612727|EG001|Reported Event|Intensive Phototherapy|"Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.~Intensive phototherapy: Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days."
11257883|NCT02612779|BG000|Baseline|EPd Cohort|Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
11257884|NCT02612779|BG001|Baseline|EN Cohort|Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
11257885|NCT02612779|BG002|Baseline|Total|Total of all reporting groups
11257886|NCT02612779|FG000|Participant Flow|EPd Cohort|Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
11257887|NCT02612779|FG001|Participant Flow|EN Cohort|Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
11257888|NCT02612779|OG000|Outcome|EPd Cohort|Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
11257889|NCT02612779|OG000|Outcome|EN Cohort|Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
11257890|NCT02612779|OG001|Outcome|EN Cohort|Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
11257891|NCT02612779|EG000|Reported Event|EPd Cohort|Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
11257892|NCT02612779|EG001|Reported Event|EN Cohort|Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
11257893|NCT02612857|BG000|Baseline|Placebo|"normal saline subcutaneous injections once a week for 24 weeks.~Placebo: normal saline subcutaneous injections once a week for 24 weeks."
11257894|NCT02612857|BG001|Baseline|IMO-8400 Dose Group 1|"IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks."
11257895|NCT02612857|BG002|Baseline|IMO-8400 Dose Group 2|"IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks."
11257896|NCT02612857|BG003|Baseline|Total|Total of all reporting groups
11257897|NCT02612857|FG000|Participant Flow|Placebo|"normal saline subcutaneous injections once a week for 24 weeks.~Placebo: normal saline subcutaneous injections once a week for 24 weeks."
11257898|NCT02612857|FG001|Participant Flow|IMO-8400 Dose Group 1|"IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 1: 0.6mg/kg IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks."
11257899|NCT02612857|FG002|Participant Flow|IMO-8400 Dose Group 2|"IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 2: 1.8mg/kg IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks."
11257900|NCT02612857|OG000|Outcome|Placebo|"normal saline subcutaneous injections once a week for 24 weeks.~Placebo: normal saline subcutaneous injections once a week for 24 weeks."
11257901|NCT02612857|OG001|Outcome|IMO-8400 Dose Group 1|"IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks."
11257902|NCT02612857|OG002|Outcome|IMO-8400 Dose Group 2|"IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks."
11257903|NCT02612857|EG000|Reported Event|Placebo|"normal saline subcutaneous injections once a week for 24 weeks.~Placebo: normal saline subcutaneous injections once a week for 24 weeks."
11257904|NCT02612857|EG001|Reported Event|IMO-8400 Dose Group 1|"IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks."
11257905|NCT02612857|EG002|Reported Event|IMO-8400 Dose Group 2|"IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.~IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks."
11257906|NCT02612909|BG000|Baseline|Phase 2: Placebo|Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257907|NCT02612909|BG001|Baseline|Phase 2: Vaccine (15 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257908|NCT02612909|BG002|Baseline|Phase 2: Vaccine (30 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257909|NCT02612909|BG003|Baseline|Phase 3: Placebo|Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257910|NCT02612909|BG004|Baseline|Phase 3: Vaccine|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257911|NCT02612909|BG005|Baseline|Total|Total of all reporting groups
11257912|NCT02612909|FG000|Participant Flow|Phase 2: Placebo|Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257913|NCT02612909|FG001|Participant Flow|Phase 2: Vaccine (15 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257914|NCT02612909|FG002|Participant Flow|Phase 2: Vaccine (30 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257915|NCT02612909|FG003|Participant Flow|Phase 3: Placebo|Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257916|NCT02612909|FG004|Participant Flow|Phase 3: Vaccine|Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257917|NCT02612909|OG000|Outcome|Phase 2: Placebo|Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257918|NCT02612909|OG001|Outcome|Phase 2: Vaccine (15 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257919|NCT02612909|OG002|Outcome|Phase 2: Vaccine (30 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257920|NCT02612909|OG003|Outcome|Phase 3: Placebo|Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257921|NCT02612909|OG004|Outcome|Phase 3: Vaccine|Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257922|NCT02612909|OG000|Outcome|Phase 3: Placebo|Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257923|NCT02612909|OG001|Outcome|Phase 3: Vaccine|Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257924|NCT02612909|EG000|Reported Event|Phase 2: Placebo|Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257925|NCT02612909|EG001|Reported Event|Phase 2: Vaccine (15 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257926|NCT02612909|EG002|Reported Event|Phase 2: Vaccine (30 mcg)|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257927|NCT02612909|EG003|Reported Event|Phase 3: Placebo|Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
11257928|NCT02612909|EG004|Reported Event|Phase 3: Vaccine|Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
11257929|NCT02613117|BG000|Baseline|Potassium Oxalate Gel|"potassium oxalate gel self applied~Potassium Oxalate Gel: Self applied"
11257930|NCT02613117|BG001|Baseline|Oxalate Liquid, SnF2 Paste|"Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied~Potassium Oxalate Liquid: Professionally Applied~Stannous fluoride paste: SnF2 Paste"
11257931|NCT02613117|BG002|Baseline|Total|Total of all reporting groups
11257932|NCT02613117|FG000|Participant Flow|Potassium Oxalate Gel|"potassium oxalate gel self applied~Potassium Oxalate Gel: Self applied"
11257933|NCT02613117|FG001|Participant Flow|Oxalate Liquid, SnF2 Paste|"Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied~Potassium Oxalate Liquid: Professionally Applied~Stannous fluoride paste: SnF2 Paste"
11257934|NCT02613117|OG000|Outcome|Potassium Oxalate Gel|"potassium oxalate gel self applied~Potassium Oxalate Gel: Self applied"
11257935|NCT02613117|OG001|Outcome|Oxalate Liquid, SnF2 Paste|"Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied~Potassium Oxalate Liquid: Professionally Applied~Stannous fluoride paste: SnF2 Paste"
11257936|NCT02613117|EG000|Reported Event|Potassium Oxalate Gel|"potassium oxalate gel self applied~Potassium Oxalate Gel: Self applied"
11257937|NCT02613117|EG001|Reported Event|Oxalate Liquid, SnF2 Paste|"Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied~Potassium Oxalate Liquid: Professionally Applied~Stannous fluoride paste: SnF2 Paste"
11257938|NCT02613169|BG000|Baseline|Isoniazid|"Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.~Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection."
11257939|NCT02613169|BG001|Baseline|No Isoniazid|No INH will be administered to this arm.
11257940|NCT02613169|BG002|Baseline|Total|Total of all reporting groups
11257941|NCT02613169|FG000|Participant Flow|Isoniazid|"Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.~Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection."
11257942|NCT02613169|FG001|Participant Flow|No Isoniazid|No INH will be administered to this arm.
11257943|NCT02613169|OG000|Outcome|Isoniazid|"Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.~Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection."
11257944|NCT02613169|OG001|Outcome|No Isoniazid|No INH will be administered to this arm.
11257945|NCT02613169|EG000|Reported Event|Isoniazid|"Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.~Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection."
11257946|NCT02613169|EG001|Reported Event|No Isoniazid|No INH will be administered to this arm.
11257947|NCT02613182|BG000|Baseline|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 28 days for 22 months (open-label study drug)
11257948|NCT02613182|FG000|Participant Flow|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 28 days for 22 months
11257949|NCT02613182|OG000|Outcome|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 28 days for 22 months
11257950|NCT02613182|EG000|Reported Event|NEOD001 24 mg/kg|24 mg/kg IV every 28 days for 22 months
11257951|NCT02613208|BG000|Baseline|Participants With Metastatic Breast Cancer|Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
11257952|NCT02613208|FG000|Participant Flow|Participants With Metastatic Breast Cancer|Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
11257953|NCT02613208|OG000|Outcome|Participants With Metastatic Breast Cancer|Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
11257954|NCT02613208|EG000|Reported Event|Participants With Metastatic Breast Cancer|Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
11257955|NCT02613221|BG000|Baseline|Panitumumab + TAS-102|Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m² given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course).
11257956|NCT02613221|FG000|Participant Flow|Panitumumab + TAS-102|Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m² given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course).
11257957|NCT02613221|OG000|Outcome|Panitumumab + TAS-102|Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m² given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course).
11257958|NCT02613221|EG000|Reported Event|Panitumumab + TAS-102|Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m² given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course).
11257959|NCT02613338|BG000|Baseline|DePuy Attune PS FB Knee System|"Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system~DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative."
10969945|NCT00908037|OG000|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
11257960|NCT02613338|FG000|Participant Flow|DePuy Attune PS FB Knee System|"Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system~DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative."
11257961|NCT02613338|OG000|Outcome|DePuy Attune PS FB Knee System|"Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system~DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative."
11257962|NCT02613338|EG000|Reported Event|DePuy Attune PS FB Knee System|"Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system~DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative."
11257963|NCT02613364|BG000|Baseline|Arm I (Behavioral Intervention-yoga)|"Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.~Behavioral Intervention: Undergo yoga intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257964|NCT02613364|BG001|Baseline|Arm II (Cognitive Intervention-CBT-I)|"Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.~Cognitive Intervention: Undergo CBT-I intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257965|NCT02613364|BG002|Baseline|Arm III (Educational Intervention)|"Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families.~Educational Intervention: Receive health education~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257966|NCT02613364|BG003|Baseline|Total|Total of all reporting groups
11257967|NCT02613364|FG000|Participant Flow|Arm I (Behavioral Intervention-yoga)|"Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.~Behavioral Intervention: Undergo yoga intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11337411|NCT03583606|EG000|Reported Event|ChAd3-EBO-Z + Placebo|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
10820320|NCT00056563|BG000|Baseline|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11257968|NCT02613364|FG001|Participant Flow|Arm II (Cognitive Intervention-CBT-I)|"Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.~Cognitive Intervention: Undergo CBT-I intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257969|NCT02613364|FG002|Participant Flow|Arm III (Educational Intervention)|"Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families.~Educational Intervention: Receive health education~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257970|NCT02613364|OG000|Outcome|Arm I (Behavioral Intervention-yoga)|"Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.~Behavioral Intervention: Undergo yoga intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257971|NCT02613364|OG001|Outcome|Arm II (Cognitive Intervention-CBT-I)|"Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.~Cognitive Intervention: Undergo CBT-I intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257972|NCT02613364|OG002|Outcome|Arm III (Educational Intervention)|"Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families.~Educational Intervention: Receive health education~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257973|NCT02613364|EG000|Reported Event|Arm I (Behavioral Intervention-yoga)|"Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.~Behavioral Intervention: Undergo yoga intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257974|NCT02613364|EG001|Reported Event|Arm II (Cognitive Intervention-CBT-I)|"Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.~Cognitive Intervention: Undergo CBT-I intervention~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257975|NCT02613364|EG002|Reported Event|Arm III (Educational Intervention)|"Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families.~Educational Intervention: Receive health education~Laboratory Biomarker Analysis: Correlative studies~Monitoring Device: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11257976|NCT02613403|BG000|Baseline|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257977|NCT02613403|BG001|Baseline|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257978|NCT02613403|BG002|Baseline|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257979|NCT02613403|BG003|Baseline|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257980|NCT02613403|BG004|Baseline|Total|Total of all reporting groups
11257981|NCT02613403|FG000|Participant Flow|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 [50 mg]) + uprifosbuvir (UPR; MK-3682 [225 mg]) + ruzasvir (RZR; MK-8408 [30 mg]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.
11257982|NCT02613403|FG001|Participant Flow|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257983|NCT02613403|FG002|Participant Flow|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
10848112|NCT00288587|OG000|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
11257984|NCT02613403|FG003|Participant Flow|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257985|NCT02613403|FG004|Participant Flow|[Part B] Prior DAA (GT1-6) or SOF/PR (GT3) Failure: MK-3682B|C or NC HCV participants previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT 3 only) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 16 weeks.
11257986|NCT02613403|OG000|Outcome|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257987|NCT02613403|OG001|Outcome|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257988|NCT02613403|OG002|Outcome|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257989|NCT02613403|OG003|Outcome|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257990|NCT02613403|EG000|Reported Event|[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257991|NCT02613403|EG001|Reported Event|[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257992|NCT02613403|EG002|Reported Event|[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
11257993|NCT02613403|EG003|Reported Event|[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B|C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
11257994|NCT02613481|BG000|Baseline|Poly-L-Lactic Acid (Sculptra) Injection|"Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects~Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject."
11257995|NCT02613481|FG000|Participant Flow|Poly-L-Lactic Acid (Sculptra) Injection|"Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects~Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject."
11257996|NCT02613481|OG000|Outcome|Poly-L-Lactic Acid (Sculptra) Injection|"Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects~Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject."
10848113|NCT00288587|OG001|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
11257997|NCT02613481|EG000|Reported Event|Poly-L-Lactic Acid (Sculptra) Injection|"Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects~Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject."
11257998|NCT02613572|BG000|Baseline|Alpha Lipoic Acid (ALA) 600, 800 &1200 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11257999|NCT02613572|BG001|Baseline|Placebo 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258000|NCT02613572|BG002|Baseline|Alpha Lipoic Acid (ALA) 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258001|NCT02613572|BG003|Baseline|Total|Total of all reporting groups
11258002|NCT02613572|FG000|Participant Flow|Alpha Lipoic Acid (ALA) 600, 800, 1200 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11337412|NCT03583606|EG001|Reported Event|ChAd3-EBO-Z + ChAd3-EBO-Z|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10^11 vp) intramuscularly into the opposite arm on Day 8.
11258003|NCT02613572|FG001|Participant Flow|Placebo 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258004|NCT02613572|FG002|Participant Flow|Alpha Lipoic Acid (ALA) 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258005|NCT02613572|OG000|Outcome|Alpha Lipoic Acid (ALA) 600 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258006|NCT02613572|OG001|Outcome|Alpha Lipoic Acid (ALA) 800 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258007|NCT02613572|OG002|Outcome|Alpha Lipoic Acid (ALA) 1200 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258008|NCT02613572|OG000|Outcome|Placebo 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258009|NCT02613572|OG001|Outcome|Alpha Lipoic Acid (ALA) 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258010|NCT02613572|EG000|Reported Event|Alpha Lipoic Acid (ALA) 600 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258011|NCT02613572|EG001|Reported Event|Alpha Lipoic Acid (ALA) 800 mg|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258012|NCT02613572|EG002|Reported Event|Alpha Lipoic Acid (ALA) 1200 mg (Phase I)|Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
11258013|NCT02613572|EG003|Reported Event|Placebo 1200mg|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
10969946|NCT00908037|OG000|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo QD for 7 weeks.
11258014|NCT02613572|EG004|Reported Event|Alpha Lipoic Acid (ALA) 1200mg (Phase II)|Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
11258015|NCT02613871|BG000|Baseline|LDV/SOF FDC|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
10820321|NCT00056563|BG001|Baseline|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
11258016|NCT02613871|FG000|Participant Flow|LDV/SOF FDC|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
11258017|NCT02613871|OG000|Outcome|LDV/SOF FDC|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
10820322|NCT00056563|BG002|Baseline|Total|Total of all reporting groups
11258018|NCT02613871|EG000|Reported Event|LDV/SOF FDC|LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
11258019|NCT02613884|BG000|Baseline|Treatment|All patients with a 25OHD level <30 ng/dL & given 250,000 IU D3 (cholecalciferol).
11258020|NCT02613884|FG000|Participant Flow|Treatment With High-Dose D3|All patients with a 25OHD level <30 ng/dL will be given 250,000 IU D3 (cholecalciferol) orally at one point in time and during CF clinic.
11258021|NCT02613884|OG000|Outcome|Treatment With High-Dose D3|All patients with a 25OHD level <30 ng/dL will be given 250,000 IU D3 (cholecalciferol) orally at one point in time and during CF clinic.
11258022|NCT02613884|OG000|Outcome|Treatment|All patients with a 25OHD level <30 ng/dL & given 250,000 IU D3 (cholecalciferol).
11258023|NCT02613884|EG000|Reported Event|Treatment|All patients with a 25OHD level <30 ng/dL & given 250,000 IU D3 (cholecalciferol).
11258024|NCT02613897|BG000|Baseline|Dapa/Saxa|Subjects with type 2 diabetes were enrolled into this study and received the intervention of Dapagliflozin plus Saxa
11258025|NCT02613897|BG001|Baseline|Dapa/Placebo|Subjects with type 2 diabetes were enrolled into this study and received the intervention of Dapagliflozin plus placebo
11258026|NCT02613897|BG002|Baseline|Placebo/Placebo|Subjects with type 2 diabetes were enrolled into this study and received the intervention of placebo plus placebo
11258027|NCT02613897|BG003|Baseline|Total|Total of all reporting groups
11258028|NCT02613897|FG000|Participant Flow|DAPA/SAXA (Dapagliflozin Plus Saxagliptin)|Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258029|NCT02613897|FG001|Participant Flow|DAPA (Dapagliflozin Plus Placebo)|Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258030|NCT02613897|FG002|Participant Flow|PCB (Placebo Plus Placebo)|Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258031|NCT02613897|OG000|Outcome|DAPA/SAXA (Dapagliflozin Plus Saxagliptin)|Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258032|NCT02613897|OG001|Outcome|DAPA (Dapagliflozin Plus Placebo)|Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258033|NCT02613897|OG002|Outcome|PCB (Placebo Plus Placebo)|"Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).~Placebo: Placebo"
11258034|NCT02613897|OG002|Outcome|PCB (Placebo Plus Placebo)|Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258035|NCT02613897|EG000|Reported Event|DAPA/SAXA (Dapagliflozin Plus Saxagliptin)|Dapagliflozin 10mg + Saxagliptin 5mg (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258036|NCT02613897|EG001|Reported Event|DAPA (Dapagliflozin Plus Placebo)|Dapagliflozin 10mg + Placebo (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258037|NCT02613897|EG002|Reported Event|PCB (Placebo Plus Placebo)|Placebo (for dapagliflozin) + placebo (for saxagliptin) (plus standard of care treatment of metformin or metformin plus sulfonylurea).
11258038|NCT02613910|BG000|Baseline|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
11258039|NCT02613910|FG000|Participant Flow|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
11258040|NCT02613910|OG000|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
11258041|NCT02613910|EG000|Reported Event|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
11258042|NCT02614079|BG000|Baseline|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
11258043|NCT02614079|FG000|Participant Flow|DSSEP - Dermatomal Somato Sensory Evoked Potentials|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
11258044|NCT02614079|OG000|Outcome|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
11258045|NCT02614079|EG000|Reported Event|DSSEP|"DSSEP testing after SCS trial lead placement~DSSEP: Collision testing after the placement of SCS leads"
11258046|NCT02614131|BG000|Baseline|Placebo (Part A)|Placebo matching dose given subcutaneously (SC) once.
11258047|NCT02614131|BG001|Baseline|10 mg LY2599666 (Part A Cohort 1)|10 mg LY2599666 given SC once.
11258048|NCT02614131|BG002|Baseline|25 mg LY2599666 (Part A Cohort 2)|25 mg LY2599666 given SC once.
11258049|NCT02614131|BG003|Baseline|100 mg LY2599666 (Part A Cohort 3)|100 mg LY2599666 given SC once.
11258050|NCT02614131|BG004|Baseline|200 mg LY2599666 (Part A Cohort 4)|200 mg LY2599666 given SC once.
11258051|NCT02614131|BG005|Baseline|Placebo (Part B)|Placebo matching dose given SC.
11258052|NCT02614131|BG006|Baseline|25 mg LY2599666 (Part B Cohort 5)|25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
11258053|NCT02614131|BG007|Baseline|Total|Total of all reporting groups
11258054|NCT02614131|FG000|Participant Flow|Placebo (Part A - Healthy Participants)|Placebo matching dose given subcutaneously (SC) once.
11258055|NCT02614131|FG001|Participant Flow|10 mg LY2599666 (Part A Cohort 1)|10 mg LY2599666 given SC once.
11258056|NCT02614131|FG002|Participant Flow|25 mg LY2599666 (Part A Cohort 2)|25 mg LY2599666 given SC once.
11258057|NCT02614131|FG003|Participant Flow|100 mg LY2599666 (Part A Cohort 3)|100 mg LY2599666 given SC once.
11258058|NCT02614131|FG004|Participant Flow|200 mg LY2599666 (Part A Cohort 4)|200 mg LY2599666 given SC once.
11258059|NCT02614131|FG005|Participant Flow|Placebo (Part B - Cognitively Impaired)|Placebo matching dose given SC.
11258060|NCT02614131|FG006|Participant Flow|25 mg LY2599666 (Part B Cohort 5)|25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
10820323|NCT00056563|FG000|Participant Flow|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11258061|NCT02614131|OG000|Outcome|Placebo (Part A)|Placebo matching dose given subcutaneously (SC) once.
11258062|NCT02614131|OG001|Outcome|10 mg LY2599666 (Part A Cohort 1)|10 mg LY2599666 given SC once.
11258063|NCT02614131|OG002|Outcome|25 mg LY2599666 (Part A Cohort 2)|25 mg LY2599666 given SC once.
11258064|NCT02614131|OG003|Outcome|100 mg LY2599666 (Part A Cohort 3)|100 mg LY2599666 given SC once.
11258065|NCT02614131|OG004|Outcome|200 mg LY2599666 (Part A Cohort 4)|200 mg LY2599666 given SC once.
11258066|NCT02614131|OG005|Outcome|Placebo (Part B)|Placebo matching dose given SC.
11258067|NCT02614131|OG006|Outcome|25 mg LY2599666 (Part B Cohort 5)|25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
11258068|NCT02614131|OG000|Outcome|10 mg LY2599666 (Part A Cohort 1)|10 mg LY2599666 given SC once.
11258069|NCT02614131|OG001|Outcome|25 mg LY2599666 (Part A Cohort 2)|25 mg LY2599666 given SC once.
11258070|NCT02614131|OG002|Outcome|100 mg LY2599666 (Part A Cohort 3)|100 mg LY2599666 given SC once.
11258071|NCT02614131|OG003|Outcome|200 mg LY2599666 (Part A Cohort 4)|200 mg LY2599666 given SC once.
11258072|NCT02614131|OG000|Outcome|25 mg LY2599666 (Part B Cohort 5)|25 mg LY2599666 given SC once weekly.
11258073|NCT02614131|OG000|Outcome|25 mg LY2599666 (Part B Cohort 5) Day 85|25 mg LY2599666 given SC once weekly.
11258074|NCT02614131|EG000|Reported Event|Placebo (Part A)|Placebo matching dose given subcutaneously (SC) once.
11258075|NCT02614131|EG001|Reported Event|10 mg LY2599666 (Part A Cohort 1)|10 mg LY2599666 given SC once.
11258076|NCT02614131|EG002|Reported Event|25 mg LY2599666 (Part A Cohort 2)|25 mg LY2599666 given SC once.
11258077|NCT02614131|EG003|Reported Event|100 mg LY2599666 (Part A Cohort 3)|100 mg LY2599666 given SC once.
11258078|NCT02614131|EG004|Reported Event|200 mg LY2599666 (Part A Cohort 4)|200 mg LY2599666 given SC once.
11258079|NCT02614131|EG005|Reported Event|Placebo (Part B)|Placebo matching dose given SC.
11258080|NCT02614131|EG006|Reported Event|25 mg LY2599666 (Part B Cohort 5)|25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
11258081|NCT02614183|BG000|Baseline|Placebo|Participants received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
11258082|NCT02614183|BG001|Baseline|Galcanezumab 120mg|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
11258083|NCT02614183|BG002|Baseline|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
11258084|NCT02614183|BG003|Baseline|Total|Total of all reporting groups
11258085|NCT02614183|FG000|Participant Flow|Placebo|Participants (pts) received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
11258086|NCT02614183|FG001|Participant Flow|Galcanezumab 120mg|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
11258087|NCT02614183|FG002|Participant Flow|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
11258088|NCT02614183|OG000|Outcome|Placebo|Participants received placebo by subcutaneous injection once a month for 6 months.
11258089|NCT02614183|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11258090|NCT02614183|OG002|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
11258091|NCT02614183|OG000|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11258092|NCT02614183|OG001|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
11258093|NCT02614183|OG002|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months
11258094|NCT02614183|EG000|Reported Event|Placebo - Treatment Phase|Participants received placebo by subcutaneous injection once a month for 6 months.
11258095|NCT02614183|EG001|Reported Event|Galcanezumab 120mg - Treatment Phase|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11258096|NCT02614183|EG002|Reported Event|Galcanezumab 240mg - Treatment Phase|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
11258097|NCT02614183|EG003|Reported Event|Placebo - Post-Treatment Phase|Participants didn't receive any intervention.
11258098|NCT02614183|EG004|Reported Event|Galcanezumab 120mg - Post-Treatment Phase|Participants didn't receive any intervention.
11258099|NCT02614183|EG005|Reported Event|Galcanezumab 240mg - Post-Treatment Phase|Participants didn't receive any intervention.
11258100|NCT02614196|BG000|Baseline|Placebo|Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258101|NCT02614196|BG001|Baseline|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258102|NCT02614196|BG002|Baseline|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258103|NCT02614196|BG003|Baseline|Placebo Maximum Extended Enrollment Cohort|Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258104|NCT02614196|BG004|Baseline|Galcanezumab 120mg Maximum Extended Enrollment Cohort|Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258105|NCT02614196|BG005|Baseline|Galcanezumab 240mg Maximum Extended Enrollment Cohort|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258106|NCT02614196|BG006|Baseline|Total|Total of all reporting groups
11258107|NCT02614196|FG000|Participant Flow|Placebo|Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258108|NCT02614196|FG001|Participant Flow|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258109|NCT02614196|FG002|Participant Flow|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258110|NCT02614196|FG003|Participant Flow|Placebo Maximum Extended Enrollment Cohort|Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
10820324|NCT00056563|FG001|Participant Flow|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
11258111|NCT02614196|FG004|Participant Flow|Galcanezumab 120mg Maximum Extended Enrollment Cohort|Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258112|NCT02614196|FG005|Participant Flow|Galcanezumab 240mg Maximum Extended Enrollment Cohort|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
11258113|NCT02614196|OG000|Outcome|Placebo|Participants received placebo by subcutaneous injection once a month for 6 months.
11258114|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11258115|NCT02614196|OG002|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
11258116|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11258117|NCT02614196|OG000|Outcome|Placebo|Participants received placebo subcutaneously once a month for 6 months.
11258118|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab followed by 120mg galcanezumab once a month for 5 months subcutaneously.
11258119|NCT02614196|OG002|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab subcutaneously once a month for 6 months.
11258120|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
11258121|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
11258122|NCT02614196|OG001|Outcome|Galcanezumab120mg|Participants received loading dose of 240mg galcanezumab followed by 120mg galcanezumab once a month for 5 months subcutaneously.
10820325|NCT00056563|OG000|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11258123|NCT02614196|OG001|Outcome|Galcanezumab120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
11258124|NCT02614196|OG000|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
11258125|NCT02614196|OG001|Outcome|Galcanezumab 240mg|Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
11258126|NCT02614196|OG001|Outcome|Galcanezumab 120mg|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
11258127|NCT02614196|EG000|Reported Event|Placebo - Treatment Phase|Participants received placebo subcutaneously once a month for 6 months.
11258128|NCT02614196|EG001|Reported Event|Galcanezumab 120mg - Treatment Phase|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
11258129|NCT02614196|EG002|Reported Event|Galcanezumab 240mg - Treatment Phase|Participants received 240mg galcanezumab subcutaneously once a month for 6 months.
11258130|NCT02614196|EG003|Reported Event|Placebo - Post-treatment Phase|Participants didn't receive any intervention.
11258131|NCT02614196|EG004|Reported Event|Galcanezumab 120mg - Post-treatment Phase|Participants didn't receive any intervention.
11258132|NCT02614196|EG005|Reported Event|Galcanezumab 240mg - Post-treatment Phase|Participants didn't receive any intervention.
11258133|NCT02614196|EG006|Reported Event|Placebo - Treatment Phase ME2|Participants received placebo subcutaneously once a month for 6 months.
11258134|NCT02614196|EG007|Reported Event|Galcanezumab 120mg - Treatment Phase ME2|Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
11258135|NCT02614196|EG008|Reported Event|Galcanezumab 240mg - Treatment Phase ME2|Participants received 240mg galcanezumab subcutaneously once a month for 6 months.
11258136|NCT02614196|EG009|Reported Event|Placebo - Post-treatment Phase ME2|Participants didn't receive any intervention.
11258137|NCT02614196|EG010|Reported Event|Galcanezumab 120mg - Post-treatment Phase ME2|Participants didn't receive any intervention.
11258138|NCT02614196|EG011|Reported Event|Galcanezumab 240mg - Post-treatment Phase ME2|Participants didn't receive any intervention.
11258139|NCT02614222|BG000|Baseline|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11258140|NCT02614222|BG001|Baseline|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11258141|NCT02614222|BG002|Baseline|Total|Total of all reporting groups
10820326|NCT00056563|OG001|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
11258142|NCT02614222|FG000|Participant Flow|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11258143|NCT02614222|FG001|Participant Flow|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11258144|NCT02614222|OG000|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11258145|NCT02614222|OG001|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11258146|NCT02614222|EG000|Reported Event|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
11258147|NCT02614222|EG001|Reported Event|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
11258148|NCT02614274|BG000|Baseline|Nutraceutical Joint Health Formulation|A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
11258149|NCT02614274|FG000|Participant Flow|Nutraceutical Joint Health Formulation|A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
11258150|NCT02614274|OG000|Outcome|Nutraceutical Joint Health Formulation|A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
11258151|NCT02614274|EG000|Reported Event|Nutraceutical Joint Health Formulation|A Proprietary combination of Glucosamine HCl, Chondroitin Sulfate, Avocado/Soybean Unsaponifiables (ASU), and 3-O-Acetyl-11-Keto β-Boswellic Acid (AKBA)
11258152|NCT02614287|BG000|Baseline|Galcanezumab 120 mg|Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase.
11258153|NCT02614287|BG001|Baseline|Galcanezumab 240 mg|Participants received 240 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase.
11258154|NCT02614287|BG002|Baseline|Total|Total of all reporting groups
11258155|NCT02614287|FG000|Participant Flow|Galcanezumab 120 mg|Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
11258156|NCT02614287|FG001|Participant Flow|Galcanezumab 240 mg|Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
11258157|NCT02614287|OG000|Outcome|Galcanezumab 120 mg|Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.
11258158|NCT02614287|OG001|Outcome|Galcanezumab 240 mg|Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
11258159|NCT02614287|OG000|Outcome|Galcanezumab 120 mg|Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
11258160|NCT02614287|OG000|Outcome|Galcanezumab 120 mg|Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 12 months.
11258161|NCT02614287|OG000|Outcome|Galcanezumab 120 mg|Participants received a loading dose of 240 mg of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
11258162|NCT02614287|EG000|Reported Event|Galcanezumab 120 mg - Open Label Phase|Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg Galcanezumab once a month by subcutaneous injection for 11 months.
11258163|NCT02614287|EG001|Reported Event|Galcanezumab 240 mg - Open Label Phase|Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
11258164|NCT02614287|EG002|Reported Event|Galcanezumab 120 mg - Post-treatment Phase|Participants did not receive any intervention.
11258165|NCT02614287|EG003|Reported Event|Galcanezumab 240 mg - Post-treatment Phase|Participants did not receive any intervention.
11258166|NCT02614469|BG000|Baseline|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
11258167|NCT02614469|BG001|Baseline|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
11258168|NCT02614469|BG002|Baseline|Total|Total of all reporting groups
11258169|NCT02614469|FG000|Participant Flow|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
11258170|NCT02614469|FG001|Participant Flow|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
11258171|NCT02614469|OG000|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
11258172|NCT02614469|OG001|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
11258173|NCT02614469|EG000|Reported Event|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
11258174|NCT02614469|EG001|Reported Event|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
11258175|NCT02614560|BG000|Baseline|Pre-allo (Before Stem Cell Transplant)|"Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)~Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)~Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant~vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant"
11258176|NCT02614560|BG001|Baseline|Post-allo (After Stem Cell Transplant)|"Post-allo vadastuximab talirine~vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle"
11258177|NCT02614560|BG002|Baseline|Total|Total of all reporting groups
11258178|NCT02614560|FG000|Participant Flow|Pre-allo (Before Stem Cell Transplant)|"Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)~Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)~Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant~vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant"
11258179|NCT02614560|FG001|Participant Flow|Post-allo (After Stem Cell Transplant)|"Post-allo vadastuximab talirine~vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle"
11258180|NCT02614560|OG000|Outcome|Pre-allo (Before Stem Cell Transplant)|"Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)~Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)~Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant~vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant"
11258181|NCT02614560|OG001|Outcome|Post-allo (After Stem Cell Transplant)|"Post-allo vadastuximab talirine~vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle"
11258182|NCT02614560|EG000|Reported Event|Pre-allo (Before Stem Cell Transplant)|"Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)~Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)~Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant~vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant"
11258183|NCT02614560|EG001|Reported Event|Post-allo (After Stem Cell Transplant)|"Post-allo vadastuximab talirine~vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle"
11258184|NCT02614703|BG000|Baseline|Chromoendoscopy Using Acetic Acid 2.5%|"Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus"
11258185|NCT02614703|BG001|Baseline|Standard Random Esophageal Biopsies|"Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)"
11258186|NCT02614703|BG002|Baseline|Total|Total of all reporting groups
11258187|NCT02614703|FG000|Participant Flow|Chromoendoscopy Using Acetic Acid 2.5%|"Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus"
11258188|NCT02614703|FG001|Participant Flow|Standard Random Esophageal Biopsies|"Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)"
11258189|NCT02614703|OG000|Outcome|Chromoendoscopy Using Acetic Acid 2.5%|"Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus"
11258190|NCT02614703|OG001|Outcome|Standard Random Esophageal Biopsies|"Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Standard random esophageal biopsies: Random esophageal biopsies performed as per protocol"
11258191|NCT02614703|EG000|Reported Event|Chromoendoscopy Using Acetic Acid 2.5%|"Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus"
11258192|NCT02614703|EG001|Reported Event|Standard Random Esophageal Biopsies|"Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.~Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)"
11258193|NCT02614729|BG000|Baseline|Energy Balance Comparison|"Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals"
11258194|NCT02614729|BG001|Baseline|Energy Restriction Comparison|"Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day."
11258195|NCT02614729|BG002|Baseline|Total|Total of all reporting groups
11337413|NCT03583606|EG002|Reported Event|ChAd3-EBO-Z + MVA- BN-Filo|ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
10848114|NCT00288587|EG000|Reported Event|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
11258196|NCT02614729|FG000|Participant Flow|Energy Balance Comparison|"Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals"
11258197|NCT02614729|FG001|Participant Flow|Energy Restriction Comparison|"Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day."
11258198|NCT02614729|OG000|Outcome|Energy Balance Comparison|"Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals"
11258199|NCT02614729|OG001|Outcome|Energy Restriction Comparison|"Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day."
11258200|NCT02614729|OG000|Outcome|Energy Balance Comparison|"Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef & plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef & plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef & plant proteins. Meals are unevenly distributed throughout the day."
11258201|NCT02614729|OG001|Outcome|Energy Restriction Comparison|"Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day."
11258202|NCT02614729|EG000|Reported Event|Energy Balance Comparison|"Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals"
11258203|NCT02614729|EG001|Reported Event|Energy Restriction Comparison|"Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.~Interventions:~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)~Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.~Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.~High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day."
11258204|NCT02614924|BG000|Baseline|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
11258205|NCT02614924|BG001|Baseline|Pentax AWS Videolaryngoscope Group|Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
11258206|NCT02614924|BG002|Baseline|Total|Total of all reporting groups
11258207|NCT02614924|FG000|Participant Flow|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
11258208|NCT02614924|FG001|Participant Flow|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
11258209|NCT02614924|OG000|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
11258210|NCT02614924|OG001|Outcome|Pentax AWS Videolaryngoscope|randomly allocated to Pentax AWs
11258211|NCT02614924|OG001|Outcome|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
11258212|NCT02614924|EG000|Reported Event|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
11258213|NCT02614924|EG001|Reported Event|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS group Pentax AWS videolaryngoscope group: Patient intubated with Pentax AWS
11258214|NCT02615145|BG000|Baseline|2 DAA+RBV|Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
11258215|NCT02615145|BG001|Baseline|3DAA|Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
11258216|NCT02615145|BG002|Baseline|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
11258217|NCT02615145|BG003|Baseline|Total|Total of all reporting groups
11258218|NCT02615145|FG000|Participant Flow|Genotype 1a Participants|Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1- participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label.
11258219|NCT02615145|FG001|Participant Flow|Genotype 1b Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
11258220|NCT02615145|FG002|Participant Flow|Genotype 4 Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
11258221|NCT02615145|FG003|Participant Flow|Missing|Treatment-naïve or -experienced participants with confirmed CHC but no genotype information.
11258222|NCT02615145|OG000|Outcome|All Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
11258223|NCT02615145|OG001|Outcome|All Genotype 1 Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
11258224|NCT02615145|OG002|Outcome|Genotype 1a Participants|Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
11258225|NCT02615145|OG003|Outcome|Genotype 1b Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
11258226|NCT02615145|OG004|Outcome|Genotype 4 Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
11258227|NCT02615145|OG000|Outcome|All Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
11258228|NCT02615145|OG000|Outcome|All Participants|Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label
11258229|NCT02615145|OG001|Outcome|Genotype 1 Participants|Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
11258230|NCT02615145|OG000|Outcome|2 DAA+RBV|2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
11258231|NCT02615145|OG001|Outcome|3DAA|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
11258232|NCT02615145|OG002|Outcome|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV
11258233|NCT02615145|OG000|Outcome|All Participants|Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label.
11258234|NCT02615145|OG000|Outcome|Total|"2DAA: paritaprevir/ritonavir - ombitasvir [ABBVIE REGIMEN]) plus RBV~3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN])~3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV"
11258235|NCT02615145|OG001|Outcome|2 DAA+RBV|2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
11258236|NCT02615145|OG002|Outcome|3DAA|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
11258237|NCT02615145|OG003|Outcome|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
11258238|NCT02615145|OG002|Outcome|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
11258239|NCT02615145|OG000|Outcome|Total|2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV
11258240|NCT02615145|OG001|Outcome|2 DAA+RBV|Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
11258241|NCT02615145|OG002|Outcome|3DAA|Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
11258242|NCT02615145|OG003|Outcome|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV
11258243|NCT02615145|EG000|Reported Event|2 DAA+RBV|2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
11258244|NCT02615145|EG001|Reported Event|3DAA|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
11258245|NCT02615145|EG002|Reported Event|3DAA+RBV|3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
11258246|NCT02615158|BG000|Baseline|Maternal Lifestyle (Physical Activity and Nutrition)|"A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.~Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends."
11258247|NCT02615158|BG001|Baseline|Responsive Parenting|"A responsive parenting intervention focusing on parenting, limit setting, and development strategies.~Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development."
11258248|NCT02615158|BG002|Baseline|Child Safety|"Attention control group. The parents received intervention to promote safety among toddlers.~Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals."
11258249|NCT02615158|BG003|Baseline|Total|Total of all reporting groups
11258250|NCT02615158|FG000|Participant Flow|Maternal Lifestyle (Physical Activity and Nutrition)|"A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.~Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends."
11258251|NCT02615158|FG001|Participant Flow|Responsive Parenting|"A responsive parenting intervention focusing on parenting, limit setting, and development strategies.~Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development."
11258252|NCT02615158|FG002|Participant Flow|Child Safety|"Attention control group. The parents received intervention to promote safety among toddlers.~Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals."
11258253|NCT02615158|OG000|Outcome|Maternal Lifestyle (Physical Activity and Nutrition)|"A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.~Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends."
11258254|NCT02615158|OG001|Outcome|Responsive Parenting|"A responsive parenting intervention focusing on parenting, limit setting, and development strategies.~Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development."
11258255|NCT02615158|OG002|Outcome|Child Safety|"Attention control group. The parents received intervention to promote safety among toddlers.~Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals."
11258256|NCT02615158|EG000|Reported Event|Maternal Lifestyle (Physical Activity and Nutrition)|"A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.~Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends."
11258257|NCT02615158|EG001|Reported Event|Responsive Parenting|"A responsive parenting intervention focusing on parenting, limit setting, and development strategies.~Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development."
11258258|NCT02615158|EG002|Reported Event|Child Safety|"Attention control group. The parents received intervention to promote safety among toddlers.~Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals."
11258259|NCT02615171|BG000|Baseline|Comprehensive Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258260|NCT02615171|BG001|Baseline|Simple Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258261|NCT02615171|BG002|Baseline|Total|Total of all reporting groups
11258262|NCT02615171|FG000|Participant Flow|Comprehensive Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258263|NCT02615171|FG001|Participant Flow|Simple Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258264|NCT02615171|OG000|Outcome|Comprehensive Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258265|NCT02615171|OG001|Outcome|Simple Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258266|NCT02615171|EG000|Reported Event|Comprehensive Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258267|NCT02615171|EG001|Reported Event|Simple Dietary Self-Monitoring|The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
11258268|NCT02615249|BG000|Baseline|All Subjects|All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
11258269|NCT02615249|FG000|Participant Flow|All Subjects|All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
11258270|NCT02615249|OG000|Outcome|All Subjects|All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. Allergen response pattern included number of positive responses that were late (initially observed at day 7 or later) or persistent (positive response that persisted from one study visit to the next) and number of negative responses that were doubtful or irritant.
11258271|NCT02615249|OG000|Outcome|All Subjects|All enrolled subjects were patch tested with ascending doses of investigational allergens and excipient controls on panels 1-6. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose.
11258272|NCT02615249|EG000|Reported Event|All Subjects|Subjects patched with at least 1 patch test panel were included in adverse event reporting.
11213892|NCT02289690|OG000|Outcome|Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213893|NCT02289690|OG001|Outcome|Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213894|NCT02289690|OG002|Outcome|Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213895|NCT02289690|OG003|Outcome|Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213896|NCT02289690|OG004|Outcome|Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213897|NCT02289690|OG005|Outcome|Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213898|NCT02289690|OG006|Outcome|Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213899|NCT02289690|OG000|Outcome|Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide|Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
11213900|NCT02289690|OG001|Outcome|Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide|Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
11213901|NCT02289690|OG002|Outcome|Phase 1: Veliparib 160 mg BID + Carboplatin/Etoposide|Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
11213902|NCT02289690|OG003|Outcome|Phase 1: Veliparib 200 mg BID + Carboplatin/Etoposide|Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
11213903|NCT02289690|OG004|Outcome|Phase 1: Veliparib 240 mg BID + Carboplatin/Etoposide|Participants received 240 mg veliparib orally BID (Days -2 to 5 for 7-day schedule, Days -2 to 12 for 14-day schedule or Days -2 to 19 for continuous dosing) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
11213904|NCT02289690|OG000|Outcome|Etoposide Cycle 1 Day 1 (With Veliparib)|Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
11213905|NCT02289690|OG001|Outcome|Etoposide Cycle 2 Day 1 (No Veliparib)|Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.
11213906|NCT02289690|OG000|Outcome|Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib|"Participants in Arm A received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213907|NCT02289690|OG001|Outcome|Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo|"Participants in Arm B received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213908|NCT02289690|OG002|Outcome|Phase 2: Placebo + Carboplatin/Etoposide -> Placebo|"Participants in Arm C received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213909|NCT02289690|OG000|Outcome|Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 80 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg twice a day until disease progression or unacceptable toxicity."
11213910|NCT02289690|OG001|Outcome|Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213911|NCT02289690|OG002|Outcome|Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213912|NCT02289690|OG003|Outcome|Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213913|NCT02289690|OG004|Outcome|Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213914|NCT02289690|OG005|Outcome|Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213915|NCT02289690|OG006|Outcome|Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID until disease progression or unacceptable toxicity."
11213916|NCT02289690|EG000|Reported Event|Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11258273|NCT02615470|BG000|Baseline|Enhanced Immunization Delivery Model|"Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.~Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258274|NCT02615470|BG001|Baseline|Immunization Update|"Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258275|NCT02615470|BG002|Baseline|Total|Total of all reporting groups
11258276|NCT02615470|FG000|Participant Flow|Enhanced Immunization Delivery Model|"Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.~Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258277|NCT02615470|FG001|Participant Flow|Immunization Update|"Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258278|NCT02615470|OG000|Outcome|Enhanced Immunization Delivery Model|"Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.~Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258279|NCT02615470|OG001|Outcome|Immunization Update|"Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258280|NCT02615470|EG000|Reported Event|Enhanced Immunization Delivery Model|"Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.~Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258281|NCT02615470|EG001|Reported Event|Immunization Update|"Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.~Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules."
11258282|NCT02615509|BG000|Baseline|Imaging on Experimental Tomo Device|"Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.~After collecting the cases together with ground truth a readers study will be performed.~Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system"
11258283|NCT02615509|FG000|Participant Flow|Imaging on Experimental Tomo Device|"Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.~After collecting the cases together with ground truth a readers study will be performed.~Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system"
10848115|NCT00288587|EG001|Reported Event|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
10848116|NCT00288600|BG000|Baseline|Experimental Group - Immunoglobulin|"Intravenous Immunoglobulin and Phototherapy~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
10848117|NCT00288600|BG001|Baseline|Control Group- Normal Saline|"Normal Saline solution and Phototherapy~Normal saline solution: Normal saline solution 10 ml/Kg"
11258284|NCT02615509|OG000|Outcome|Imaging on Experimental Tomo Device|"Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.~After collecting the cases together with ground truth a readers study will be performed.~Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system"
11258285|NCT02615509|EG000|Reported Event|Imaging on Experimental Tomo Device|"Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.~After collecting the cases together with ground truth a readers study will be performed.~Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system"
11258286|NCT02615535|BG000|Baseline|EEG Neurofeedback-assisted Meditation|"EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.~EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status"
11258287|NCT02615535|BG001|Baseline|Non-EEG Feedback-assisted Meditation|"Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.~Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status"
11258288|NCT02615535|BG002|Baseline|Total|Total of all reporting groups
11258289|NCT02615535|FG000|Participant Flow|EEG Neurofeedback-assisted Meditation|"EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.~EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status"
11258290|NCT02615535|FG001|Participant Flow|Non-EEG Feedback-assisted Meditation|"Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.~Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status"
11258291|NCT02615535|OG000|Outcome|EEG Neurofeedback-assisted Meditation|"EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.~EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status"
11258292|NCT02615535|OG001|Outcome|Non-EEG Feedback-assisted Meditation|"Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.~Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status"
11258293|NCT02615535|EG000|Reported Event|EEG Neurofeedback-assisted Meditation|"EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.~EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status"
11258294|NCT02615535|EG001|Reported Event|Non-EEG Feedback-assisted Meditation|"Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.~Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status"
11258295|NCT02615717|BG000|Baseline|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
11258296|NCT02615717|BG001|Baseline|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
11258297|NCT02615717|BG002|Baseline|Total|Total of all reporting groups
11258298|NCT02615717|FG000|Participant Flow|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
11258299|NCT02615717|FG001|Participant Flow|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
11258300|NCT02615717|OG000|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
10820327|NCT00056563|EG000|Reported Event|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
11258301|NCT02615717|OG001|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
11258302|NCT02615717|EG000|Reported Event|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
11258303|NCT02615717|EG001|Reported Event|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
11258304|NCT02615743|BG000|Baseline|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258305|NCT02615743|BG001|Baseline|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258306|NCT02615743|BG002|Baseline|Total|Total of all reporting groups
11258307|NCT02615743|FG000|Participant Flow|Intervention Group|"Caregivers of Intervention arm participants will receive daily text message reminders about asthma controller medication use, as well as an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258308|NCT02615743|FG001|Participant Flow|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258309|NCT02615743|OG000|Outcome|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
10848118|NCT00288600|BG002|Baseline|Total|Total of all reporting groups
10848119|NCT00288600|FG000|Participant Flow|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
11258310|NCT02615743|OG001|Outcome|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258311|NCT02615743|EG000|Reported Event|Intervention Group|"Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258312|NCT02615743|EG001|Reported Event|Control Group|"Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.~An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem."
11258313|NCT02616029|BG000|Baseline|Part 1: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258314|NCT02616029|BG001|Baseline|Part 2: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258315|NCT02616029|BG002|Baseline|Total|Total of all reporting groups
11258316|NCT02616029|FG000|Participant Flow|Part 1: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and without any other nucleos(t)ide reverse transcriptase inhibitor (NRTI)-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet orally once daily for 48 weeks.
11258317|NCT02616029|FG001|Participant Flow|Part 2: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (TAMs) switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258318|NCT02616029|OG000|Outcome|Part 1: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258319|NCT02616029|OG001|Outcome|Part 2: E/C/F/TAF|Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258320|NCT02616029|OG002|Outcome|Total E/C/F/TAF|Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258321|NCT02616029|EG000|Reported Event|Total E/C/F/TAF|Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
11258322|NCT02616250|BG000|Baseline|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
11258323|NCT02616250|BG001|Baseline|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
11258324|NCT02616250|BG002|Baseline|Total|Total of all reporting groups
11258325|NCT02616250|FG000|Participant Flow|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
11258326|NCT02616250|FG001|Participant Flow|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
11258327|NCT02616250|OG000|Outcome|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
11258328|NCT02616250|OG001|Outcome|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
11258329|NCT02616250|EG000|Reported Event|Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream|"Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.~Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.~Brimonidine 0.33% gel (Br)~CD07805/47 (Br) placebo gel~Ivermectin 1% cream (IVM)"
11258330|NCT02616250|EG001|Reported Event|CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream|"Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.~CD07805/47 (Br) placebo gel~CD5024 (IVM) placebo cream"
11258331|NCT02616380|BG000|Baseline|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11258332|NCT02616380|FG000|Participant Flow|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11258333|NCT02616380|OG000|Outcome|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11258334|NCT02616380|EG000|Reported Event|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11258335|NCT02616523|BG000|Baseline|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258336|NCT02616523|BG001|Baseline|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258337|NCT02616523|BG002|Baseline|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258338|NCT02616523|BG003|Baseline|Total|Total of all reporting groups
11258339|NCT02616523|FG000|Participant Flow|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258340|NCT02616523|FG001|Participant Flow|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258341|NCT02616523|FG002|Participant Flow|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258342|NCT02616523|OG000|Outcome|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258343|NCT02616523|OG001|Outcome|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258344|NCT02616523|OG002|Outcome|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258345|NCT02616523|OG000|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
11258346|NCT02616523|OG001|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
10848120|NCT00288600|FG001|Participant Flow|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
10848121|NCT00288600|OG000|Outcome|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
10848122|NCT00288600|OG001|Outcome|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
10848123|NCT00288600|EG000|Reported Event|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
11258347|NCT02616523|OG002|Outcome|Placebo|Participants received fentanyl boluses during the operation
11258348|NCT02616523|EG000|Reported Event|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258349|NCT02616523|EG001|Reported Event|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258350|NCT02616523|EG002|Reported Event|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
11258351|NCT02616601|BG000|Baseline|Generic Fluorouracil Cream|Participants applied up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258352|NCT02616601|BG001|Baseline|Carac (Fluorouracil) Cream|Participants applied up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258353|NCT02616601|BG002|Baseline|Vehicle Cream|Participants applied up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258354|NCT02616601|BG003|Baseline|Total|Total of all reporting groups
11258355|NCT02616601|FG000|Participant Flow|Generic Fluorouracil Cream|Participants applied up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks (wks) as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258356|NCT02616601|FG001|Participant Flow|Carac (Fluorouracil) Cream|Participants applied up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258357|NCT02616601|FG002|Participant Flow|Vehicle Cream|Participants applied up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258358|NCT02616601|OG000|Outcome|Generic Fluorouracil Cream|Participants applied up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258359|NCT02616601|OG001|Outcome|Carac (Fluorouracil) Cream|Participants applied up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258360|NCT02616601|OG002|Outcome|Vehicle Cream|Participants applied up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258361|NCT02616601|EG000|Reported Event|Generic Fluorouracil Cream|Participants applied up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258362|NCT02616601|EG001|Reported Event|Carac (Fluorouracil) Cream|Participants applied up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258363|NCT02616601|EG002|Reported Event|Vehicle Cream|Participants applied up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.
11258364|NCT02616614|BG000|Baseline|Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258365|NCT02616614|BG001|Baseline|Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258366|NCT02616614|BG002|Baseline|Vehicle Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258367|NCT02616614|BG003|Baseline|Total|Total of all reporting groups
11258368|NCT02616614|FG000|Participant Flow|Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258369|NCT02616614|FG001|Participant Flow|Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel)|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258370|NCT02616614|FG002|Participant Flow|Vehicle Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258371|NCT02616614|OG000|Outcome|Generic Clindamycin and Benzoyl Peroxide|Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC)
11258372|NCT02616614|OG001|Outcome|Reference Onexton (Clindamycin and Benzoyl Peroxide)|Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC)
11258373|NCT02616614|OG002|Outcome|Vehicle Gel|Vehicle Gel: Placebo product
11258374|NCT02616614|OG002|Outcome|Vehicle Gel|Vehicle of the test product (Actavis Laboratories SLC)
11258375|NCT02616614|EG000|Reported Event|Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258376|NCT02616614|EG001|Reported Event|Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258377|NCT02616614|EG002|Reported Event|Vehicle Gel|Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
11258378|NCT02616783|BG000|Baseline|E/C/F/TAF|Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
11258379|NCT02616783|BG001|Baseline|Stay on Baseline Regimen|Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
11258380|NCT02616783|BG002|Baseline|Total|Total of all reporting groups
11258381|NCT02616783|FG000|Participant Flow|E/C/F/TAF|Participants switched from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily for 48 weeks.
11258382|NCT02616783|FG001|Participant Flow|Stay on Baseline Regimen|Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
11258383|NCT02616783|OG000|Outcome|E/C/F/TAF|Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
11258384|NCT02616783|OG001|Outcome|Stay on Baseline Regimen|Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
11258385|NCT02616783|EG000|Reported Event|E/C/F/TAF|Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
11258386|NCT02616783|EG001|Reported Event|Stay on Baseline Regimen|Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
11258387|NCT02616900|BG000|Baseline|eSight Eyewear|"Main arm~eSight Eyewear: primary intervention"
11258388|NCT02616900|FG000|Participant Flow|eSight Eyewear|"Main arm~eSight Eyewear: primary intervention"
11258389|NCT02616900|OG000|Outcome|eSight Eyewear|"Main arm~eSight Eyewear: primary intervention"
11258390|NCT02616900|EG000|Reported Event|eSight Eyewear|"Main arm~eSight Eyewear: primary intervention"
11258391|NCT02617628|BG000|Baseline|After Re-entry|"Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone after they were released from prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling."
11258392|NCT02617628|BG001|Baseline|Before Re-entry|"Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they left the prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling."
11258393|NCT02617628|BG002|Baseline|Total|Total of all reporting groups
11258394|NCT02617628|FG000|Participant Flow|Before Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months."
11258395|NCT02617628|FG001|Participant Flow|After Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months."
11258396|NCT02617628|OG000|Outcome|Before Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.~intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling."
11258397|NCT02617628|OG001|Outcome|After Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.~outpatient treatment for six months. Subjects also received weekly psychosocial counseling."
11258398|NCT02617628|OG000|Outcome|Before Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months."
11258399|NCT02617628|OG001|Outcome|After Re-entry|"Extended Release Naltrexone, 380 mg injection~Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months."
11258400|NCT02617628|EG000|Reported Event|Before Re-entry|"Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling."
11258401|NCT02617628|EG001|Reported Event|After Re-entry|"Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling."
11258402|NCT02617667|BG000|Baseline|CyclASol 0.05% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258403|NCT02617667|BG001|Baseline|CyclASol 0.1% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258404|NCT02617667|BG002|Baseline|Placebo Ophthalmic Solution|"Blinded treatment arm. Vehicle only. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258405|NCT02617667|BG003|Baseline|Restasis|"Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.~1 drop in each eye, twice daily."
11258406|NCT02617667|BG004|Baseline|Total|Total of all reporting groups
11258407|NCT02617667|FG000|Participant Flow|CyclASol 0.05% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily"
11258408|NCT02617667|FG001|Participant Flow|CyclASol 0.1% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258409|NCT02617667|FG002|Participant Flow|Placebo Ophthalmic Solution|"Blinded treatment arm. Vehicle only. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258410|NCT02617667|FG003|Participant Flow|Restasis|"Active comparator, open label arm. Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.~1 drop in each eye, twice daily."
11258411|NCT02617667|OG000|Outcome|CyclASol 0.05% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258412|NCT02617667|OG001|Outcome|CyclASol 0.1% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258413|NCT02617667|OG002|Outcome|Placebo Ophthalmic Solution|"Blinded treatment arm. Vehicle only. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258414|NCT02617667|EG000|Reported Event|CyclASol 0.05% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258415|NCT02617667|EG001|Reported Event|CyclASol 0.1% Ophthalmic Solution|"Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.~1 drop in each eye, twice daily."
11258416|NCT02617667|EG002|Reported Event|Placebo Ophthalmic Solution|"Blinded treatment arm. Vehicle only Topical ocular eye drops.~1 drop in each eye, twice daily."
11258417|NCT02617667|EG003|Reported Event|Restasis|"Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.~1 drop in each eye, twice daily."
11258418|NCT02617784|BG000|Baseline|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
11258419|NCT02617784|BG001|Baseline|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
11258420|NCT02617784|BG002|Baseline|Total|Total of all reporting groups
11258421|NCT02617784|FG000|Participant Flow|Oseltamivir With HD|Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
11258422|NCT02617784|FG001|Participant Flow|Oseltamivir With CAPD|Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
11258423|NCT02617784|OG000|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
11258424|NCT02617784|OG000|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
11258425|NCT02617784|EG000|Reported Event|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
11258426|NCT02617784|EG001|Reported Event|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
11258427|NCT02617888|BG000|Baseline|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
11258428|NCT02617888|BG001|Baseline|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
11258429|NCT02617888|BG002|Baseline|Observational Arm|1. Non-female patients undergoing coronary CTA; 2. Patients undergoing nuclear cardiology stress testing; 3. Patients undergoing invasive coronary angiography.
11258430|NCT02617888|BG003|Baseline|Total|Total of all reporting groups
11258431|NCT02617888|FG000|Participant Flow|CCTA Breast Shields|"Within female subset, randomization to wearing bismuth breast shield.~."
11258432|NCT02617888|FG001|Participant Flow|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
11258433|NCT02617888|FG002|Participant Flow|Observational|Non-female patients undergoing coronary CTA, patients undergoing nuclear cardiology studies and invasive coronary angiography.
11258434|NCT02617888|OG000|Outcome|No Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
11258435|NCT02617888|OG001|Outcome|Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
11258436|NCT02617888|EG000|Reported Event|CCTA Breast Shields|"Within female subset, randomization to wearing bismuth breast shield.~."
11258437|NCT02617888|EG001|Reported Event|CCTA No Breast Shields|"Within female subset, randomization to not wearing bismuth breast shield (standard of care).~."
11258438|NCT02617888|EG002|Reported Event|Observational Arm|Observational evaluating the dose-related impact of radiation exposure from multiple sources and types on changes in double-stranded DNA breaks.
11258439|NCT02617901|BG000|Baseline|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~Recruited children had intervention in the form of a left hand DXA which was anonymised and from which the same 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart.~Radiographs and DXA were read in random and varied order."
11258440|NCT02617901|FG000|Participant Flow|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~Recruited children had intervention in the form of a left hand DXA which was anonymised and from which 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart.~Radiographs and DXA were read in random and varied order."
11337423|NCT03584100|BG000|Baseline|Tourniquet 8000 Arm|Both arms of participants (Auxillary lymph node dissection (ALND) and other contralateral) were used.
10848124|NCT00288600|EG001|Reported Event|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
11258441|NCT02617901|OG000|Outcome|Recruited Children|"Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).~All had left hand/wrist radiograph for bone age estimation"
11258442|NCT02617901|EG000|Reported Event|Recruited Children|Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).
11258443|NCT02618031|BG000|Baseline|Favorable CIS|"Patients with a favorable Capillary Index Score (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot."
11258444|NCT02618031|BG001|Baseline|Poor CIS|"Patients with a poor Capillary Index Score (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot."
11258445|NCT02618031|BG002|Baseline|Total|Total of all reporting groups
11258446|NCT02618031|FG000|Participant Flow|Favorable CIS|"Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258447|NCT02618031|FG001|Participant Flow|Poor CIS|"Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258448|NCT02618031|OG000|Outcome|Favorable CIS|"Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258449|NCT02618031|OG001|Outcome|Poor CIS|"Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258450|NCT02618031|OG000|Outcome|Favorable CIS and Good Revascularization|"Patients with a favorable CIS (fCIS) who achieve good revascularization based on modified treatment in cerebral infarction (mTICI) score of 2B or 3~Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:~grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches"
11258451|NCT02618031|OG001|Outcome|Poor CIS and Good Revascularization|"Patients with a poor CIS (pCIS) who achieve good revascularization based on modified treatment in cerebral infarction (mTICI) score of 2B or 3~Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:~grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches"
11258452|NCT02618031|OG002|Outcome|Favorable CIS and Poor Revascularization|"Patients with a favorable CIS (fCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A~Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:~grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches"
11258453|NCT02618031|OG003|Outcome|Poor CIS and Poor Revascularization|"Patients with a poor CIS (pCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A~Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:~grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches"
11337424|NCT03584100|FG000|Participant Flow|Tourniquet 8000 Arm|Both arms of participants, ie, auxillary lymph node dissection (ALND) and contralateral (control arm) were evaluated with a low-pressure tourniquet.
11258454|NCT02618031|EG000|Reported Event|Favorable CIS|"Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258455|NCT02618031|EG001|Reported Event|Poor CIS|"Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.~Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot."
11258456|NCT02618187|BG000|Baseline|Weekly SER-287, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Placebo Pre-Treat"
11258457|NCT02618187|BG001|Baseline|Daily Placebo, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once daily placebo for 8 weeks~Placebo~Placebo Pre-Treat"
11258458|NCT02618187|BG002|Baseline|Daily SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258459|NCT02618187|BG003|Baseline|Weekly SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258460|NCT02618187|BG004|Baseline|Total|Total of all reporting groups
11258461|NCT02618187|FG000|Participant Flow|Weekly SER-287, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Placebo Pre-Treat"
11258462|NCT02618187|FG001|Participant Flow|Daily Placebo, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once daily placebo for 8 weeks~Placebo~Placebo Pre-Treat"
11258463|NCT02618187|FG002|Participant Flow|Daily SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258464|NCT02618187|FG003|Participant Flow|Weekly SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258465|NCT02618187|OG000|Outcome|Weekly SER-287, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Placebo Pre-Treat"
11258466|NCT02618187|OG001|Outcome|Daily Placebo, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once daily placebo for 8 weeks~Placebo~Placebo Pre-Treat"
11258467|NCT02618187|OG002|Outcome|Daily SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258468|NCT02618187|OG003|Outcome|Weekly SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258469|NCT02618187|EG000|Reported Event|Weekly SER-287, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Placebo Pre-Treat"
11258470|NCT02618187|EG001|Reported Event|Daily Placebo, After Placebo Pre-Treat.|"Placebo pre-treatment, followed by once daily placebo for 8 weeks~Placebo~Placebo Pre-Treat"
11258471|NCT02618187|EG002|Reported Event|Daily SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258472|NCT02618187|EG003|Reported Event|Weekly SER-287, After Vanco. Pre-Treat.|"Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks~Eubacterial Spores, Purified Suspension, Encapsulated~Vancomycin Pre-Treat"
11258473|NCT02618343|BG000|Baseline|ISOPROPYL ALCOHOL AROMATHERAPY|"Prehospital patients complaining of nausea randomized into the IPA Arm.~IPA: IPA Aromatherapy for the experimental arm"
11258474|NCT02618343|BG001|Baseline|Ondansetron|"Prehospital patients complaining of nausea randomized into the ondansetron arm.~Ondansetron: Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel."
11258475|NCT02618343|BG002|Baseline|Total|Total of all reporting groups
11258476|NCT02618343|FG000|Participant Flow|Isopropyl Alcohol|Prehospital nausea patient randomized into the IPA group
11258477|NCT02618343|FG001|Participant Flow|Ondansetron Group|Prehospital nausea patient randomized to the Ondansetron group
11258478|NCT02618343|OG000|Outcome|Isopropyl Alcohol|Prehospital nausea patient randomized into the IPA group
11258479|NCT02618343|OG001|Outcome|Ondansetron Group|Prehospital nausea patient randomized to the Ondansetron group
11258480|NCT02618343|EG000|Reported Event|Isopropyl Alcohol|Prehospital nausea patient randomized into the IPA group
11258481|NCT02618343|EG001|Reported Event|Ondansetron Group|Prehospital nausea patient randomized to the Ondansetron group
11258482|NCT02618382|BG000|Baseline|All Subjects|"Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.~Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first"
11258483|NCT02618382|FG000|Participant Flow|All Subjects|"Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.~Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first"
11258484|NCT02618382|OG000|Outcome|All Subjects|"Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.~Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first"
11258485|NCT02618382|EG000|Reported Event|All Subjects|"Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.~Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first"
11258486|NCT02618512|BG000|Baseline|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
11258487|NCT02618512|FG000|Participant Flow|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
11258488|NCT02618512|OG000|Outcome|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
11258489|NCT02618512|EG000|Reported Event|SBC-103|Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days.
11258490|NCT02618616|BG000|Baseline|ZPL-389|Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.
11258491|NCT02618616|BG001|Baseline|Placebo|Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
11258492|NCT02618616|BG002|Baseline|Total|Total of all reporting groups
11258493|NCT02618616|FG000|Participant Flow|ZPL-389|Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
11258494|NCT02618616|FG001|Participant Flow|Placebo|Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
11258495|NCT02618616|OG000|Outcome|ZPL-389|Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.
11258496|NCT02618616|OG001|Outcome|Placebo|Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
10969947|NCT00908037|OG001|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
11258497|NCT02618616|OG000|Outcome|ZPL-389|Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
11258498|NCT02618616|EG000|Reported Event|ZPL-389|Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.
11258499|NCT02618616|EG001|Reported Event|Placebo|Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
11258500|NCT02618642|BG000|Baseline|Group x: PILER Irradiation Treatments With Red Filter|Piler light + red filter Group x: irradiation with a red filter (visible red radiation and infrared; 650-800 nm and 800-3900 nm, respectively) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
11258501|NCT02618642|BG001|Baseline|Group y: PILER Irradiation Treatments With Blue Filter|Piler light + blue filter Group y: irradiation with a blue filter (blue radiation; 440-480 nm) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
11258502|NCT02618642|BG002|Baseline|Group v: PILER Irradiation Treatments Without a Filter|Piler light without a filter Group v: irradiation without a filter (white radiation in the entire spectrum and near-infrared radiation; 480-3400 nm) one session lasted 10 minutes 10 irradiations to the biceps brachii muscle
11258503|NCT02618642|BG003|Baseline|Group z: Placebo|placebo Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm). time of phototherapy treatment: 3 minutes for one session distance of 1meter 10 irradiations to the biceps brachii muscle
11258504|NCT02618642|BG004|Baseline|Total|Total of all reporting groups
11258505|NCT02618642|FG000|Participant Flow|PILER Light Irradiation Treatments With Red Filter|Group x: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation with a red filter (visible red radiation and infrared; 650-800 nm and 800-3900 nm, respectively), each session lasted 10 minutes,
11258506|NCT02618642|FG001|Participant Flow|PILER Light Irradiation Treatments With Blue Filter|Group y: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation with a blue filter (blue radiation; 440-480 nm), each session lasted 10 minutes,
11258507|NCT02618642|FG002|Participant Flow|PILER Light Irradiation Treatments Without a Filter|Group v: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation without filter (white radiation in the entire spectrum and near-infrared radiation; 480-3400 nm), each session lasted 10 minutes,
11258508|NCT02618642|FG003|Participant Flow|Placebo|Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm); each session lasted 3 minutes
11258509|NCT02618642|OG000|Outcome|Piler Light + Red Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11258510|NCT02618642|OG001|Outcome|Piler Light + Blue Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11258511|NCT02618642|OG002|Outcome|Piler Light Without a Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11258512|NCT02618642|OG003|Outcome|Placebo|3 min irradiation with Piler light from 1 meter
11258513|NCT02618642|OG000|Outcome|PILER Light Irradiation Treatments With Red Filter|Piler light + red filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
11258514|NCT02618642|OG001|Outcome|PILER Light Irradiation Treatments With Blue Filter|Piler light + blue filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
11258515|NCT02618642|OG002|Outcome|PILER Light Irradiation Treatments Without a Filter|Piler light without a filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
11258516|NCT02618642|OG000|Outcome|Group x: PILER Irradiation Treatments With Red Filter|Piler light + red filter Group x: irradiation with a red filter (visible red radiation and infrared; 650-800 nm and 800-3900 nm, respectively) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
11258517|NCT02618642|OG001|Outcome|Group y: PILER Irradiation Treatments With Blue Filter|Piler light + blue filter Group y: irradiation with a blue filter (blue radiation; 440-480 nm) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
11258518|NCT02618642|OG002|Outcome|Group v: PILER Irradiation Treatments Without a Filter|Piler light without a filter Group v: irradiation without a filter (white radiation in the entire spectrum and near-infrared radiation; 480-3400 nm) one session lasted 10 minutes 10 irradiations to the biceps brachii muscle
10820328|NCT00056563|EG001|Reported Event|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
10969948|NCT00908037|OG000|Outcome|Part 2/ 3 Eltrombopag Open-Label Period|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
10969949|NCT00908037|OG000|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11258519|NCT02618642|OG003|Outcome|Group z: Placebo|placebo Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm). time of phototherapy treatment: 3 minutes for one session distance of 1meter 10 irradiations to the biceps brachii muscle
11258520|NCT02618642|EG000|Reported Event|Piler Light + Red Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11258521|NCT02618642|EG001|Reported Event|Piler Light + Blue Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11337425|NCT03584100|OG000|Outcome|Change in Hand Volume Following Tourniquet Use in Axillary Lymph Node Dissection (ALND) Arm|Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for axillary lymph node dissection (ALND) arm.
11258522|NCT02618642|EG002|Reported Event|Piler Light Without a Filter|"Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session~Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session~Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people"
11258523|NCT02618642|EG003|Reported Event|Placebo|3 min irradiation with Piler light from 1 meter
11258524|NCT02618759|BG000|Baseline|DSXS1505|"To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.~DSXS: active treatment~Placebo: placebo treatment"
11258525|NCT02618759|BG001|Baseline|Placebo|"Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.~DSXS: active treatment~Placebo: placebo treatment"
11258526|NCT02618759|BG002|Baseline|Total|Total of all reporting groups
11258527|NCT02618759|FG000|Participant Flow|DSXS1505|"To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.~DSXS: active treatment~Placebo: placebo treatment"
11258528|NCT02618759|FG001|Participant Flow|Placebo|"Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.~DSXS: active treatment~Placebo: placebo treatment"
11258529|NCT02618759|OG000|Outcome|DSXS1505|"To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.~DSXS: active treatment~Placebo: placebo treatment"
11258530|NCT02618759|OG001|Outcome|Placebo|"Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.~DSXS: active treatment~Placebo: placebo treatment"
11258531|NCT02618759|EG000|Reported Event|DSXS1505|"To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.~DSXS: active treatment~Placebo: placebo treatment"
11258532|NCT02618759|EG001|Reported Event|Placebo|"Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.~DSXS: active treatment~Placebo: placebo treatment"
11258533|NCT02618772|BG000|Baseline|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
11258534|NCT02618772|BG001|Baseline|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
11258535|NCT02618772|BG002|Baseline|Total|Total of all reporting groups
11258536|NCT02618772|FG000|Participant Flow|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
11258537|NCT02618772|FG001|Participant Flow|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
11258538|NCT02618772|OG000|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
11258539|NCT02618772|OG001|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
11258540|NCT02618772|EG000|Reported Event|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
11258541|NCT02618772|EG001|Reported Event|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
11258542|NCT02618915|BG000|Baseline|DTX101, Cohort 1|a single peripheral IV infusion of 1.6 x 10^12 GC/kg DTX101
11258543|NCT02618915|BG001|Baseline|DTX101, Cohort 2|a single peripheral IV infusion of 5.0 x 10^12 GC/kg DTX101
11258544|NCT02618915|BG002|Baseline|Total|Total of all reporting groups
11258545|NCT02618915|FG000|Participant Flow|DTX101, Cohort 1|a single peripheral intravenous (IV) infusion of 1.6 x 10^12 genome copies (GC)/kg DTX101
11258546|NCT02618915|FG001|Participant Flow|DTX101, Cohort 2|a single peripheral IV infusion of 5.0 x 10^12 GC/kg DTX101
11258547|NCT02618915|OG000|Outcome|DTX101, Cohort 1|a single peripheral IV infusion of 1.6 x 10^12 GC/kg DTX101
11258548|NCT02618915|OG001|Outcome|DTX101, Cohort 2|a single peripheral IV infusion of 5.0 x 10^12 GC/kg DTX101
11258549|NCT02618915|OG000|Outcome|DTX101, Dose 1|1.6 x 10^12 genome copies (GC)/kg DTX101
11258550|NCT02618915|OG001|Outcome|DTX101, Dose 3|5.0 x 10^12 GC/kg DTX101
11258551|NCT02618915|EG000|Reported Event|DTX101, Cohort 1|a single peripheral IV infusion of 1.6 x 10^12 GC/kg DTX101
11258552|NCT02618915|EG001|Reported Event|DTX101, Cohort 2|a single peripheral IV infusion of 5.0 x 10^12 GC/kg DTX101
11258553|NCT02618928|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11258554|NCT02618928|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11258555|NCT02618928|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11258556|NCT02618928|EG000|Reported Event|Paritaprevir/Ritonavir + Ombitasvir Without RBV|Participants received paritaprevir/ritonavir and ombitasvir without ribavirin for either 12 weeks.
11258557|NCT02618928|EG001|Reported Event|Paritaprevir/Ritonavir + Ombitasvir With RBV|Participants received paritaprevir/ritonavir and ombitasvir with ribavirin for either 12 weeks.
11258558|NCT02618928|EG002|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 8 or 12 weeks.
11258559|NCT02618928|EG003|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11258560|NCT02618967|BG000|Baseline|AMG 570 - 7 mg|Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
11258561|NCT02618967|BG001|Baseline|AMG 570 - 21 mg|Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
11258562|NCT02618967|BG002|Baseline|AMG 570 - 70 mg|Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
11258563|NCT02618967|BG003|Baseline|AMG 570 - 140 mg|Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
11258564|NCT02618967|BG004|Baseline|AMG 570 - 210 mg|Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
11258565|NCT02618967|BG005|Baseline|AMG 570 - 420 mg|Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
11258566|NCT02618967|BG006|Baseline|AMG 570 - 700 mg|Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
11258567|NCT02618967|BG007|Baseline|Placebo|Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
11258568|NCT02618967|BG008|Baseline|Total|Total of all reporting groups
11258569|NCT02618967|FG000|Participant Flow|AMG 570 - 7 mg|Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
11258570|NCT02618967|FG001|Participant Flow|AMG 570 - 21 mg|Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
11258571|NCT02618967|FG002|Participant Flow|AMG 570 - 70 mg|Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
11258572|NCT02618967|FG003|Participant Flow|AMG 570 - 140 mg|Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
11258573|NCT02618967|FG004|Participant Flow|AMG 570 - 210 mg|Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
11258574|NCT02618967|FG005|Participant Flow|AMG 570 - 420 mg|Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
11258575|NCT02618967|FG006|Participant Flow|AMG 570 - 700 mg|Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
11258576|NCT02618967|FG007|Participant Flow|Placebo|Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
11258577|NCT02618967|OG000|Outcome|AMG 570 - 7 mg|Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
11258578|NCT02618967|OG001|Outcome|AMG 570 - 21 mg|Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
11258579|NCT02618967|OG002|Outcome|AMG 570 - 70 mg|Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
11258580|NCT02618967|OG003|Outcome|AMG 570 - 140 mg|Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
11258581|NCT02618967|OG004|Outcome|AMG 570 - 210 mg|Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
11258582|NCT02618967|OG005|Outcome|AMG 570 - 420 mg|Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
11258583|NCT02618967|OG006|Outcome|AMG 570 - 700 mg|Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
11258584|NCT02618967|OG007|Outcome|Placebo|Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
11258585|NCT02618967|EG000|Reported Event|AMG 570 - 7 mg|Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
11258586|NCT02618967|EG001|Reported Event|AMG 570 - 21 mg|Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
11258587|NCT02618967|EG002|Reported Event|AMG 570 - 70 mg|Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
11258588|NCT02618967|EG003|Reported Event|AMG 570 - 140 mg|Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
11258589|NCT02618967|EG004|Reported Event|AMG 570 - 210 mg|Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
11258590|NCT02618967|EG005|Reported Event|AMG 570 - 420 mg|Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
11258591|NCT02618967|EG006|Reported Event|AMG 570 - 700 mg|Participants received 700 mg dose of AMG 570 administered as single dose subcutaneous in healthy volunteers.
11258592|NCT02618967|EG007|Reported Event|Placebo|Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
11258593|NCT02619175|BG000|Baseline|Perturbation-based Balance Training|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258594|NCT02619175|BG001|Baseline|Weight Shifting and Gait Training|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258595|NCT02619175|BG002|Baseline|Total|Total of all reporting groups
11258596|NCT02619175|FG000|Participant Flow|Perturbation-based Balance Training, Stroke Subjects|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258597|NCT02619175|FG001|Participant Flow|Weight Shifting and Gait Training, Stroke Subjects|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258598|NCT02619175|OG000|Outcome|Perturbation-based Balance Training|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258599|NCT02619175|OG001|Outcome|Weight Shifting and Gait Training|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258600|NCT02619175|OG000|Outcome|Perturbation Based Balance Training|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258601|NCT02619175|OG001|Outcome|Weight-shifting and Gait Training|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258602|NCT02619175|OG000|Outcome|Perturbation-based Balance Training, Stroke Subjects|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258603|NCT02619175|OG001|Outcome|Weight Shifting and Gait Training, Stroke Subjects|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258604|NCT02619175|EG000|Reported Event|BalanceTutor|"perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~BalanceTutor"
11258605|NCT02619175|EG001|Reported Event|Posturograph|"Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.~10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.~posturograph"
11258606|NCT02619396|BG000|Baseline|"Group 20 W / LSI 4"|Patients elected to AF ablation and randomized to Combination 1 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
11258607|NCT02619396|BG001|Baseline|"Group 40 W / LSI 4"|Patients elected to AF ablation and randomized to Combination 2 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
11258608|NCT02619396|BG002|Baseline|"Group 20 W / LSI 5"|Patients elected to AF ablation and randomized to Combination 3 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
11258609|NCT02619396|BG003|Baseline|"Group 40 W / LSI 5"|Patients elected to AF ablation and randomized to Combination 4 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
11258610|NCT02619396|BG004|Baseline|Total|Total of all reporting groups
11258611|NCT02619396|FG000|Participant Flow|"Group 20 W / LSI 4"|"Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall~Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall"
11258612|NCT02619396|FG001|Participant Flow|"Group 40 W / LSI 4"|"Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall~Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall"
11258613|NCT02619396|FG002|Participant Flow|"Group 20 W / LSI 5"|"Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall~Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall"
11258614|NCT02619396|FG003|Participant Flow|"Group 40 W / LSI 5"|"Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall~Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall"
11258615|NCT02619396|OG000|Outcome|"Group 20 W / LSI 4"|"Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall~Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall"
11258616|NCT02619396|OG001|Outcome|"Group 40 W / LSI 4"|"Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall~Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall"
11258617|NCT02619396|OG002|Outcome|"Group 20 W / LSI 5"|"Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall~Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall"
11258618|NCT02619396|OG003|Outcome|"Group 40 W / LSI 5"|"Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall~Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall"
11258619|NCT02619396|OG002|Outcome|"Group 20 W / LSI 5"|"Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall~Combination 3of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall"
11258620|NCT02619396|EG000|Reported Event|"Group 20 W / LSI 4"|"Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall~Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall"
11258621|NCT02619396|EG001|Reported Event|"Group 40 W / LSI 4"|"Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall~Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall"
11258622|NCT02619396|EG002|Reported Event|"Group 20 W / LSI 5"|"Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall~Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall"
11258623|NCT02619396|EG003|Reported Event|"Group 40 W / LSI 5"|"Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall~Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall"
11258624|NCT02619409|BG000|Baseline|Bupivacaine Only|"The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.~Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc."
11258625|NCT02619409|BG001|Baseline|EPI25 Group|"The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.~EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc."
11258626|NCT02619409|BG002|Baseline|EPI50 Group|"The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.~EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc"
11258627|NCT02619409|BG003|Baseline|EPI75 Group|"The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.~EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%."
11258628|NCT02619409|BG004|Baseline|EPI100 Group|"The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc~EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc."
11258629|NCT02619409|BG005|Baseline|Total|Total of all reporting groups
11258630|NCT02619409|FG000|Participant Flow|Bupivacaine Only|"The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.~Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc."
11258631|NCT02619409|FG001|Participant Flow|EPI25 Group|"The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.~EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc."
11258632|NCT02619409|FG002|Participant Flow|EPI50 Group|"The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.~EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc"
11258633|NCT02619409|FG003|Participant Flow|EPI75 Group|"The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.~EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%."
11258634|NCT02619409|FG004|Participant Flow|EPI100 Group|"The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc~EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc."
11258635|NCT02619409|OG000|Outcome|Bupivacaine Only|"The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.~Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc."
11258636|NCT02619409|OG001|Outcome|EPI25 Group|"The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.~EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc."
11258637|NCT02619409|OG002|Outcome|EPI50 Group|"The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.~EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc"
11258638|NCT02619409|OG003|Outcome|EPI75 Group|"The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.~EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%."
11258639|NCT02619409|OG004|Outcome|EPI100 Group|"The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc~EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc."
11258640|NCT02619409|EG000|Reported Event|Bupivacaine Only|"The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.~Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc."
11258641|NCT02619409|EG001|Reported Event|EPI25 Group|"The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.~EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc."
11258642|NCT02619409|EG002|Reported Event|EPI50 Group|"The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.~EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc"
11258643|NCT02619409|EG003|Reported Event|EPI75 Group|"The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.~EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%."
11258644|NCT02619409|EG004|Reported Event|EPI100 Group|"The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc~EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc."
11258645|NCT02619591|BG000|Baseline|Ultrasound Imaging - Single View|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
11258646|NCT02619591|BG001|Baseline|Ultrasound Imaging - Multiple Views|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
11258647|NCT02619591|BG002|Baseline|Total|Total of all reporting groups
11258648|NCT02619591|FG000|Participant Flow|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
11258649|NCT02619591|FG001|Participant Flow|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
11258650|NCT02619591|OG000|Outcome|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
11258651|NCT02619591|OG001|Outcome|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
11258652|NCT02619591|EG000|Reported Event|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
11258653|NCT02619591|EG001|Reported Event|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
11258654|NCT02619617|BG000|Baseline|Placebo s.c. /1.5 mg SOM230 s.c.|A: single dose of placebo s.c. (Period 1) B: single dose of 1.5 mg s.c. SOM230 (Period 2)
11258655|NCT02619617|FG000|Participant Flow|Placebo s.c.|Single dose of placebo
11258656|NCT02619617|FG001|Participant Flow|SOM230 1.5 mg s.c.|Single dose of SOM230 1.5 mg s.c.
11258657|NCT02619617|OG000|Outcome|Placebo s.c.|A single dose of placebo s.c.
11258658|NCT02619617|OG001|Outcome|SOM230 1.5 mg|A single dose of 1.5 mg s.c. SOM230
11258659|NCT02619617|OG001|Outcome|SOM230 1.5 mg|single dose of 1.5 mg s.c. SOM230
11258660|NCT02619617|OG000|Outcome|Placebo s.c. /1.5 mg SOM230 s.c.|A: single dose of placebo s.c. B: single dose of 1.5 mg s.c. SOM230
11258661|NCT02619617|EG000|Reported Event|1.5 mg SOM230 s.c.|single dose of 1.5 mg s.c. SOM230
11258662|NCT02619617|EG001|Reported Event|Placebo s.c.|A single dose of placebo s.c.
11258663|NCT02619799|BG000|Baseline|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258664|NCT02619799|BG001|Baseline|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258665|NCT02619799|BG002|Baseline|Total|Total of all reporting groups
11258666|NCT02619799|FG000|Participant Flow|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258667|NCT02619799|FG001|Participant Flow|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258668|NCT02619799|OG000|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258669|NCT02619799|OG001|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258670|NCT02619799|EG000|Reported Event|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258671|NCT02619799|EG001|Reported Event|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
11258672|NCT02620020|BG000|Baseline|Placebo SC Q4W and Placebo IV Q8W|Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
11258673|NCT02620020|BG001|Baseline|Fasinumab 6 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
11258674|NCT02620020|BG002|Baseline|Fasinumab 9 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
11258675|NCT02620020|BG003|Baseline|Fasinumab 9 mg IV Q8W and Placebo SC Q4W|Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
11258676|NCT02620020|BG004|Baseline|Total|Total of all reporting groups
11258677|NCT02620020|FG000|Participant Flow|Placebo SC Q4W and Placebo IV Q8W|Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
11258678|NCT02620020|FG001|Participant Flow|Fasinumab 6 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
11258679|NCT02620020|FG002|Participant Flow|Fasinumab 9 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
11258680|NCT02620020|FG003|Participant Flow|Fasinumab 9 mg IV Q8W and Placebo SC Q4W|Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
11258681|NCT02620020|OG000|Outcome|Placebo SC Q4W and Placebo IV Q8W|Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
11258682|NCT02620020|OG001|Outcome|Fasinumab 6 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
11258683|NCT02620020|OG002|Outcome|Fasinumab 9 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
11258684|NCT02620020|OG003|Outcome|Fasinumab 9 mg IV Q8W and Placebo SC Q4W|Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
11258685|NCT02620020|EG000|Reported Event|Placebo SC Q4W and Placebo IV Q8W|"Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. Patients randomized to the 'Placebo SC Q4W and Placebo IV Q8W treatment arm who wrongly received at least one dose of active treatment were classified in the active treatment group in the SAF."
11258686|NCT02620020|EG001|Reported Event|Fasinumab 6 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.
11258687|NCT02620020|EG002|Reported Event|Fasinumab 9 mg SC Q4W and Placebo IV Q8W|Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.
11258688|NCT02620020|EG003|Reported Event|Fasinumab 9 mg IV Q8W and Placebo SC Q4W|Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.
11258689|NCT02620384|BG000|Baseline|Experimental: Placebo|"This group will receive all standard heart failure therapy and placebo pill.~Experimental: Placebo: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose."
11258690|NCT02620384|BG001|Baseline|Experimental: Metolazone|"This group will receive all standard heart failure therapy with addition of metolazone.~Experimental: Metolazone: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose."
11258691|NCT02620384|BG002|Baseline|Total|Total of all reporting groups
11258692|NCT02620384|FG000|Participant Flow|Experimental: Placebo|"This group will receive all standard heart failure therapy and placebo pill.~Experimental: Placebo: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose."
11258693|NCT02620384|FG001|Participant Flow|Experimental: Metolazone|"This group will receive all standard heart failure therapy with addition of metolazone.~Experimental: Metolazone: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose."
11258694|NCT02620384|OG000|Outcome|Experimental: Placebo|"This group will receive all standard heart failure therapy and placebo pill.~Experimental: Placebo: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose."
11258695|NCT02620384|OG001|Outcome|Experimental: Metolazone|"This group will receive all standard heart failure therapy with addition of metolazone.~Experimental: Metolazone: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose."
11258696|NCT02620384|EG000|Reported Event|Experimental: Placebo|"This group will receive all standard heart failure therapy and placebo pill.~Experimental: Placebo: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose."
11258697|NCT02620384|EG001|Reported Event|Experimental: Metolazone|"This group will receive all standard heart failure therapy with addition of metolazone.~Experimental: Metolazone: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose."
11258698|NCT02620683|BG000|Baseline|All Study Participants|Subjects who were randomized to receive either Buffered or Non-Buffered Lidocaine
11258699|NCT02620683|FG000|Participant Flow|Buffered Lidocaine, Then Non-buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
11258700|NCT02620683|FG001|Participant Flow|Non-buffered Lidocaine, Then Buffererd Lidocaine|At Visit 1 each subject received Non-Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Buffered Lidocaine in the same fashion at Visit 2.
11258701|NCT02620683|OG000|Outcome|Buffered Lidocaine and Non-Buffered Lidocaine|At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
11258702|NCT02620683|EG000|Reported Event|Buffered Lidicaine|"In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block.~Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels~Lidocaine: See above"
11337426|NCT03584100|OG001|Outcome|Change in Hand Volume Following Tourniquet Use in Contralateral Arm|Mean change in hand volume from baseline to 30 minutes after placement of the pneumatic tourniquet, for contralateral control arm.
11258703|NCT02620683|EG001|Reported Event|Non-bufered Lidocaine|"In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block. At least a week later injections would involve the alternate local anesthetic combination.~Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels~Lidocaine: See above"
11258704|NCT02620774|BG000|Baseline|Diabetic Wound Infection|Participants with a documented history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 8 hours.
11258705|NCT02620774|BG001|Baseline|Healthy Volunteer|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid in the thigh by a microdialysis probe over 8 hours.
11258706|NCT02620774|BG002|Baseline|Total|Total of all reporting groups
11258707|NCT02620774|FG000|Participant Flow|Diabetic Wound Infection|Participants with a documented history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 8 hours.
11258708|NCT02620774|FG001|Participant Flow|Healthy Volunteer|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid in the thigh by a microdialysis probe over 8 hours.
11258709|NCT02620774|OG000|Outcome|Diabetic Wound Infection|Participants with a documented history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 8 hours.
11258710|NCT02620774|OG001|Outcome|Healthy Volunteer|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid in the thigh by a microdialysis probe over 8 hours.
11258711|NCT02620774|EG000|Reported Event|Diabetic Wound Infection|Participants with a documented history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 8 hours.
11258712|NCT02620774|EG001|Reported Event|Healthy Volunteer|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive at least 3 doses of intravenous ceftolozane/tazobactam 1.5g every 8 hours, followed by sampling of interstitial tissue fluid in the thigh by a microdialysis probe over 8 hours.
11258713|NCT02620787|BG000|Baseline|Diabetic Wound Infection|"Participants with a documented medical history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.~Tedizolid~Microdialysis Catheter Insertion: A 20 kila-Dalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection."
11258714|NCT02620787|BG001|Baseline|Healthy Volunteers|"Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.~Tedizolid~Microdialysis Catheter Insertion: A 20 kila-Dalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection."
11258715|NCT02620787|BG002|Baseline|Total|Total of all reporting groups
11258716|NCT02620787|FG000|Participant Flow|Diabetic Wound Infection|Participants with a documented medical history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258717|NCT02620787|FG001|Participant Flow|Healthy Volunteers|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258718|NCT02620787|OG000|Outcome|Diabetic Wound Infection|Participants with a documented medical history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258719|NCT02620787|OG001|Outcome|Healthy Volunteers|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258720|NCT02620787|EG000|Reported Event|Diabetic Wound Infection|Participants with a documented medical history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258721|NCT02620787|EG001|Reported Event|Healthy Volunteers|Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours.
11258722|NCT02620878|BG000|Baseline|All Study Participants|"Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp.~artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence."
11258723|NCT02620878|FG000|Participant Flow|Open Loop Than Closed Loop|Patients used for 3 days subcutaneous delivery of insulin according to usual pump regimen (open loop), than artificial pancreas for 3 days
11258724|NCT02620878|FG001|Participant Flow|Closed Loop Than Open Loop|Patients used for 3 days artificial pancreas, than subcutaneous delivery of insulin according to usual pump regimen (open loop) for 3 days
11258725|NCT02620878|OG000|Outcome|CLOSED LOOP|"Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp.~artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence."
11258726|NCT02620878|OG001|Outcome|OPEN LOOP|"Active Comparator: SAP teraphy (CGM + insulin pump) will be used for 72 hours during day and night (3 days).~sensor augmented pump: During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas"
11258727|NCT02620878|EG000|Reported Event|CLOSED LOOP|"Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp.~artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence."
11258728|NCT02620878|EG001|Reported Event|OPEN LOOP|"Active Comparator: SAP teraphy (CGM + insulin pump) will be used for 72 hours during day and night (3 days).~sensor augmented pump: During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas"
11258729|NCT02620904|BG000|Baseline|Mifepristone|"following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery~Mifepristone"
11258730|NCT02620904|BG001|Baseline|Placebo Pill|"following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery~placebo"
11258731|NCT02620904|BG002|Baseline|Total|Total of all reporting groups
11258732|NCT02620904|FG000|Participant Flow|Mifepristone|"following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery~Mifepristone"
11258733|NCT02620904|FG001|Participant Flow|Placebo Pill|"following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery~placebo"
11258734|NCT02620904|OG000|Outcome|Mifepristone|"following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery~Mifepristone"
11258735|NCT02620904|OG001|Outcome|Placebo Pill|"following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery~placebo"
11258736|NCT02620904|EG000|Reported Event|Mifepristone|"following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery~Mifepristone"
11258737|NCT02620904|EG001|Reported Event|Placebo Pill|"following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery~placebo"
11258738|NCT02620917|BG000|Baseline|CSII Treatment|Patients who received CSII treatment in Italy
11258739|NCT02620917|FG000|Participant Flow|Continuous Subcutaneous Insulin Infusion (CSII) Treatment|Patients who received Continuous subcutaneous insulin infusion (CSII) treatment in Italy
11258740|NCT02620917|OG000|Outcome|CSII Treatment|Patients who received CSII treatment in Italy
11258741|NCT02620917|OG000|Outcome|Adults on CSII Treatment|Patients who received CSII treatment in Italy ( = or > 18 YEARS OLD)
11258742|NCT02620917|OG001|Outcome|Paediatric Patients on CSII Treatment|Patients < 18 years old ON CSII treatment
11258743|NCT02620917|EG000|Reported Event|CSII Treatment|Patients who received CSII treatment in Italy
11258744|NCT02621034|BG000|Baseline|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
11258745|NCT02621034|BG001|Baseline|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
11258746|NCT02621034|BG002|Baseline|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
11258747|NCT02621034|BG003|Baseline|Total|Total of all reporting groups
11258748|NCT02621034|FG000|Participant Flow|k File|"hand instrumentation~k file: hand instrumentation"
11258749|NCT02621034|FG001|Participant Flow|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
11258750|NCT02621034|FG002|Participant Flow|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
11258751|NCT02621034|OG000|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
11258752|NCT02621034|OG001|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
11258753|NCT02621034|OG002|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
11258754|NCT02621034|OG000|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
11258755|NCT02621034|OG001|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
11258756|NCT02621034|EG000|Reported Event|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
11258757|NCT02621034|EG001|Reported Event|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
11258758|NCT02621034|EG002|Reported Event|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
11258759|NCT02621047|BG000|Baseline|Alectinib: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 milligrams (mg) on Day 1.
11258760|NCT02621047|BG001|Baseline|Alectinib: Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 mg on Day 1.
11258761|NCT02621047|BG002|Baseline|Alectinib: Normal Hepatic Function|Participants with normal hepatic function received alectinib at a single oral dose of 300 mg on Day 1.
11258762|NCT02621047|BG003|Baseline|Total|Total of all reporting groups
11258763|NCT02621047|FG000|Participant Flow|Alectinib: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 milligrams (mg) on Day 1.
11258764|NCT02621047|FG001|Participant Flow|Alectinib: Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 mg on Day 1.
11258765|NCT02621047|FG002|Participant Flow|Alectinib: Normal Hepatic Function|Participants with normal hepatic function received alectinib at a single oral dose of 300 mg on Day 1.
11258766|NCT02621047|OG000|Outcome|Alectinib: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 milligrams (mg) on Day 1.
11258767|NCT02621047|OG001|Outcome|Alectinib: Normal Moderate Matched Control|Participants with normal hepatic function matched to the participants in moderate hepatic impairment group (based on Child-Pugh score), on the basis of age, body weight and gender, received alectinib at a single oral dose of 300 mg on Day 1.
11258768|NCT02621047|OG002|Outcome|Alectinib: Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 mg on Day 1.
11258769|NCT02621047|OG003|Outcome|Alectinib: Normal Severe Matched Control|Participants with normal hepatic function matched to the participants in severe hepatic impairment group (based on Child-Pugh score), on the basis of age, body weight and gender, received alectinib at a single oral dose of 300 mg on Day 1.
11258770|NCT02621047|EG000|Reported Event|Alectinib: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 milligrams (mg) on Day 1.
11258771|NCT02621047|EG001|Reported Event|Alectinib: Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh score) received alectinib at a single oral dose of 300 mg on Day 1.
11258772|NCT02621047|EG002|Reported Event|Alectinib: Normal Hepatic Function|Participants with normal hepatic function received alectinib at a single oral dose of 300 mg on Day 1.
11258773|NCT02621060|BG000|Baseline|Placebo|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Placebo: Placebo: 1200 mg per day for three months"
11258774|NCT02621060|BG001|Baseline|Chlorogenic Acid|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Chlorogenic acid: Chologenic acid: 1200 mg per day for three months"
11258775|NCT02621060|BG002|Baseline|Total|Total of all reporting groups
11258776|NCT02621060|FG000|Participant Flow|Placebo|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Placebo: Placebo: 1200 mg per day for three months"
11258777|NCT02621060|FG001|Participant Flow|Chlorogenic Acid|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Chlorogenic acid: Chologenic acid: 1200 mg per day for three months"
11258778|NCT02621060|OG000|Outcome|Placebo|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Placebo: Placebo: 1200 mg per day for three months"
11258779|NCT02621060|OG001|Outcome|Chlorogenic Acid|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Chlorogenic acid: Chologenic acid: 1200 mg per day for three months"
11258780|NCT02621060|EG000|Reported Event|Placebo|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Placebo: Placebo: 1200 mg per day for three months"
11258781|NCT02621060|EG001|Reported Event|Chlorogenic Acid|"1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.~Chlorogenic acid: Chologenic acid: 1200 mg per day for three months"
11258782|NCT02621073|BG000|Baseline|VeraFlo With Prontosan|VeraFlo with Prontosan: VeraFlo device with Prontosan instillation
11258783|NCT02621073|BG001|Baseline|V.A.C Ulta System|V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation
11258784|NCT02621073|BG002|Baseline|Total|Total of all reporting groups
11258785|NCT02621073|FG000|Participant Flow|VeraFlo With Prontosan|VeraFlo with Prontosan: VeraFlo device with Prontosan instillation.
11258786|NCT02621073|FG001|Participant Flow|V.A.C Ulta System|V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation
11258787|NCT02621073|OG000|Outcome|VeraFlo With Prontosan|"V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010).~VeraFlo with Prontosan: VeraFlo device with Prontosan instillation (n=10)."
11258788|NCT02621073|OG001|Outcome|V.A.C Ulta System|"The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation.~V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10)."
11258789|NCT02621073|EG000|Reported Event|VeraFlo With Prontosan|"V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010).~VeraFlo with Prontosan: VeraFlo device with Prontosan instillation (n=10)."
11258790|NCT02621073|EG001|Reported Event|V.A.C Ulta System|"The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation.~V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10)."
11258791|NCT02621463|BG000|Baseline|Noninvasive Ventilation|"Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator.~Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used."
11258792|NCT02621463|FG000|Participant Flow|Noninvasive Ventilation|"Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator.~Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used."
11258793|NCT02621463|OG000|Outcome|Noninvasive Ventilation|"Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator.~Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used."
11258794|NCT02621463|EG000|Reported Event|Noninvasive Ventilation|"Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator.~Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used."
11258795|NCT02621619|BG000|Baseline|IV Acetaminophen + 0.5 mg IV Hydromorphone|"1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone~IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258796|NCT02621619|BG001|Baseline|Placebo + 0.5 mg IV Hydromorphone|"100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone~Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258797|NCT02621619|BG002|Baseline|Total|Total of all reporting groups
11258798|NCT02621619|FG000|Participant Flow|IV Acetaminophen + 0.5 mg IV Hydromorphone|"1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone~IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258799|NCT02621619|FG001|Participant Flow|Placebo + 0.5 mg IV Hydromorphone|"100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone~Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258800|NCT02621619|OG000|Outcome|IV Acetaminophen + 0.5 mg IV Hydromorphone|"1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone~IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258801|NCT02621619|OG001|Outcome|Placebo + 0.5 mg IV Hydromorphone|"100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone~Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258802|NCT02621619|EG000|Reported Event|IV Acetaminophen + 0.5 mg IV Hydromorphone|"1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone~IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258803|NCT02621619|EG001|Reported Event|Placebo + 0.5 mg IV Hydromorphone|"100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone~Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone~0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone"
11258804|NCT02621892|BG000|Baseline|50mg BID|"Tenapanor~Tenapanor"
11258805|NCT02621892|BG001|Baseline|Placebo|"Placebo~Placebo"
11258806|NCT02621892|BG002|Baseline|Total|Total of all reporting groups
11258807|NCT02621892|FG000|Participant Flow|50mg BID|"Tenapanor~Tenapanor"
11258808|NCT02621892|FG001|Participant Flow|Placebo|"Placebo~Placebo"
11258809|NCT02621892|OG000|Outcome|50mg BID|"Tenapanor~Tenapanor"
11258810|NCT02621892|OG001|Outcome|Placebo|"Placebo~Placebo"
11258811|NCT02621892|EG000|Reported Event|50mg BID|"Tenapanor~Tenapanor"
11258812|NCT02621892|EG001|Reported Event|Placebo|"Placebo~Placebo"
11258813|NCT02621931|BG000|Baseline|Placebo|Participants randomized to the placebo treatment arm received three 1.5-mL placebo injections at Day 0 and a single 1.5-mL placebo injection at Days 28 and 56 .
11258814|NCT02621931|BG001|Baseline|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11258815|NCT02621931|BG002|Baseline|Fremanezumab 675/225/225 mg|Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
11258816|NCT02621931|BG003|Baseline|Total|Total of all reporting groups
11258817|NCT02621931|FG000|Participant Flow|Placebo|Participants randomized to the placebo treatment arm received three 1.5-mL placebo injections at Day 0 and a single 1.5-mL placebo injection at Days 28 and 56 .
11258818|NCT02621931|FG001|Participant Flow|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11258819|NCT02621931|FG002|Participant Flow|Fremanezumab 675/225/225 mg|Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
11258820|NCT02621931|OG000|Outcome|Placebo|Participants randomized to the placebo treatment arm received three 1.5-mL placebo injections at Day 0 and a single 1.5-mL placebo injection at Days 28 and 56 .
11258821|NCT02621931|OG001|Outcome|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11258822|NCT02621931|OG002|Outcome|Fremanezumab 675/225/225 mg|Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
11258823|NCT02621931|OG000|Outcome|Placebo|Participants randomized to the placebo treatment arm received three 1.5-mL placebo injections at Day 0 and a single 1.5-mL placebo injection at Days 28 and 56.
11258824|NCT02621931|OG001|Outcome|Fremanezumab 675 mg|Participants randomized to both fremanezumab treatment arms received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0. Later treatments are beyond the timeframe for this outcome. Therefore the data from both active treatment arms were combined for this comparison.
11258825|NCT02621931|EG000|Reported Event|Placebo|Participants randomized to receive placebo received three 1.5-mL placebo injections at Day 0 and a single 1.5-mL placebo injection at Days 28 and 56.
11258826|NCT02621931|EG001|Reported Event|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11258827|NCT02621931|EG002|Reported Event|Fremanezumab 675/225/225 mg|Participants randomized to receive fremanezumab 675/225/225 mg received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
11286589|NCT02890992|FG000|Participant Flow|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|"Period 1: Participants with body weight less than (<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram (mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286590|NCT02890992|FG001|Participant Flow|Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg|"Period 1: Participants with body weight greater than or equal to (>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286591|NCT02890992|FG002|Participant Flow|Cohort 2 - Alirocumab 40 mg Q2W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11286592|NCT02890992|FG003|Participant Flow|Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130."
11286593|NCT02890992|FG004|Participant Flow|Cohort 3 - Alirocumab 75 mg Q4W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130."
11258828|NCT02621983|BG000|Baseline|Aerobic Exercise|"Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258829|NCT02621983|BG001|Baseline|Balance and Stretching|"Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258830|NCT02621983|BG002|Baseline|Total|Total of all reporting groups
11258831|NCT02621983|FG000|Participant Flow|Aerobic Exercise|"Subjects with a diagnosis of schizophrenia (SCZ) will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258832|NCT02621983|FG001|Participant Flow|Balance and Stretching|"Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258833|NCT02621983|OG000|Outcome|Aerobic Exercise|"Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258834|NCT02621983|OG001|Outcome|Balance and Stretching|"Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258835|NCT02621983|EG000|Reported Event|Aerobic Exercise|"Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258836|NCT02621983|EG001|Reported Event|Balance and Stretching|"Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.~Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks."
11258837|NCT02622074|BG000|Baseline|Cohort A: KNp / KAC|Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258838|NCT02622074|BG001|Baseline|Cohort B: KNpCb (Regimen 1) / KAC|Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258839|NCT02622074|BG002|Baseline|Cohort C: KNpCb (Regimen 2) / KAC|Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258840|NCT02622074|BG003|Baseline|Cohort D: KNpCb (Regimen 3) / KAC|Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258841|NCT02622074|BG004|Baseline|Cohort E: KTCb (Regimen 1) / KAC|Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258842|NCT02622074|BG005|Baseline|Cohort F: KTCb (Regimen 2) / KAC|Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258843|NCT02622074|BG006|Baseline|Total|Total of all reporting groups
11258844|NCT02622074|FG000|Participant Flow|Cohort A: KNp / KAC|Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258845|NCT02622074|FG001|Participant Flow|Cohort B: KNpCb (Regimen 1) / KAC|Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258846|NCT02622074|FG002|Participant Flow|Cohort C: KNpCb (Regimen 2) / KAC|Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258847|NCT02622074|FG003|Participant Flow|Cohort D: KNpCb (Regimen 3) / KAC|Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258848|NCT02622074|FG004|Participant Flow|Cohort E: KTCb (Regimen 1) / KAC|Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258849|NCT02622074|FG005|Participant Flow|Cohort F: KTCb (Regimen 2) / KAC|Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258850|NCT02622074|OG000|Outcome|Cohort A: KNp / KAC|Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258851|NCT02622074|OG001|Outcome|Cohort B: KNpCb (Regimen 1) / KAC|Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258852|NCT02622074|OG002|Outcome|Cohort C: KNpCb (Regimen 2) / KAC|Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258853|NCT02622074|OG003|Outcome|Cohort D: KNpCb (Regimen 3) / KAC|Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258854|NCT02622074|OG004|Outcome|Cohort E: KTCb (Regimen 1) / KAC|Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258855|NCT02622074|OG005|Outcome|Cohort F: KTCb (Regimen 2) / KAC|Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258856|NCT02622074|EG000|Reported Event|Cohort A: KNp / KAC|Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258857|NCT02622074|EG001|Reported Event|Cohort B: KNpCb (Regimen 1) / KAC|Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258858|NCT02622074|EG002|Reported Event|Cohort C: KNpCb (Regimen 2) / KAC|Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258859|NCT02622074|EG003|Reported Event|Cohort D: KNpCb (Regimen 3) / KAC|Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258860|NCT02622074|EG004|Reported Event|Cohort E: KTCb (Regimen 1) / KAC|Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258861|NCT02622074|EG005|Reported Event|Cohort F: KTCb (Regimen 2) / KAC|Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
11258862|NCT02622113|BG000|Baseline|Placebo/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
11258863|NCT02622113|BG001|Baseline|CANA/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
11258864|NCT02622113|BG002|Baseline|Total|Total of all reporting groups
11258865|NCT02622113|FG000|Participant Flow|Placebo/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
11258866|NCT02622113|FG001|Participant Flow|CANA/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
11258867|NCT02622113|OG000|Outcome|Placebo/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
11258868|NCT02622113|OG001|Outcome|CANA/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
11258869|NCT02622113|EG000|Reported Event|Placebo/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study
11258870|NCT02622113|EG001|Reported Event|CANA/CANA + Insulin|Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study
11258871|NCT02622178|BG000|Baseline|Healthy Subjects|"42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes for optical coherence tomography (OCT) and visual evoked potential testing (VEP).~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter wit"
11258872|NCT02622178|BG001|Baseline|Glaucoma Suspects|"45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography and visual evoked potential.~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white check"
11258873|NCT02622178|BG002|Baseline|Glaucoma Patients|"49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography and visual evoked potential.~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visu"
11258874|NCT02622178|BG003|Baseline|Total|Total of all reporting groups
11258875|NCT02622178|FG000|Participant Flow|Healthy Subjects|"42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258876|NCT02622178|FG001|Participant Flow|Glaucoma Suspects|"45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258877|NCT02622178|FG002|Participant Flow|Glaucoma Patients|"49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258878|NCT02622178|OG000|Outcome|Healthy Subjects|"42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11337427|NCT03584100|OG000|Outcome|Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Elevated|Mean change in hand volume 30 minutes after placement of the pneumatic tourniquet, between axillary lymph node dissection (ALND) arm and contralateral arm, both in the elevated position.
10820329|NCT00056862|BG000|Baseline|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
11258879|NCT02622178|OG001|Outcome|Glaucoma Suspects|"45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258880|NCT02622178|OG002|Outcome|Glaucoma Patients|"49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (cup to disc ratio greater than 0.7, rim thinning or glaucomatous Retinal Nerve Fiber Layer defects) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258881|NCT02622178|OG002|Outcome|Glaucoma Patients|"49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing.~Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD).~Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed."
11258882|NCT02622178|EG000|Reported Event|Healthy Subjects|"42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes for optical coherence tomography (OCT) and visual evoked potential testing (VEP).~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter wit"
11258883|NCT02622178|EG001|Reported Event|Glaucoma Suspects|"45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography and visual evoked potential.~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white check"
11258884|NCT02622178|EG002|Reported Event|Glaucoma Patients|"49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography and visual evoked potential.~Optical Coherence Tomography: Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.~Visual evoked potential: Visual evoked potential is a means of objectively testing visu"
11258885|NCT02622191|BG000|Baseline|Open-angle Glaucoma|"Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.~Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea."
11258886|NCT02622191|BG001|Baseline|Healthy Controls|"Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.~Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea."
11258887|NCT02622191|BG002|Baseline|Total|Total of all reporting groups
11258888|NCT02622191|FG000|Participant Flow|Open-angle Glaucoma|"Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.~Spectral domain Optical Coherence Tomography (SD-OCT): Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany)."
11258889|NCT02622191|FG001|Participant Flow|Healthy Controls|"Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.~Spectral domain Optical Coherence Tomography (SD-OCT): Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany)."
11258890|NCT02622191|OG000|Outcome|Open-angle Glaucoma Affected Eye|Affected eye of patients with primary open-angle glaucoma and visual field defect.
11258891|NCT02622191|OG001|Outcome|Healthy Controls|Eyes of healthy controls with no glaucoma or other eye diseases.
11258892|NCT02622191|OG002|Outcome|Open-angle Glaucoma Fellow Eye|Fellow eye of patients with primary open-angle glaucoma and no visual field defect.
11258893|NCT02622191|EG000|Reported Event|Open-angle Glaucoma|Participants with unilateral primary open-angle glaucoma (POAG) and visual field defect in only one eye.
11258894|NCT02622191|EG001|Reported Event|Healthy Controls|Participants without glaucoma and no other eye diseases.
11258895|NCT02622321|BG000|Baseline|Arm A: 1.5 mg/kg Emicizumab QW|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm A started to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 milligrams per kilogram (mg/kg) once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258896|NCT02622321|BG001|Baseline|Arm B (Control): No Prophylaxis, Then Emicizumab|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm B continued with their prior episodic treatment regimen for the first 24 weeks of the study; they did not receive emicizumab prophylaxis during that time. After completing at least 24 weeks on study, participants in Arm B were allowed to switch to emicizumab prophylaxis (as described for Arm A) up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258897|NCT02622321|BG002|Baseline|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258898|NCT02622321|BG003|Baseline|Arm D: 1.5 mg/kg Emicizumab QW|Participants who were either: 1) Receiving episodic bypassing agents prior to study entry but were unable to enroll in Arms A or B; or 2) Receiving bypassing agent prophylaxis prior to study entry but were unable to enroll in Arm C, were enrolled in Arm D to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258899|NCT02622321|BG004|Baseline|Total|Total of all reporting groups
11258900|NCT02622321|FG000|Participant Flow|Arm A: 1.5 mg/kg Emicizumab QW|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm A started to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 milligrams per kilogram (mg/kg) once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258901|NCT02622321|FG001|Participant Flow|Arm B (Control): No Prophylaxis, Then Emicizumab|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm B continued with their prior episodic treatment regimen for the first 24 weeks of the study; they did not receive emicizumab prophylaxis during that time. After completing at least 24 weeks on study, participants in Arm B were allowed to switch to emicizumab prophylaxis (as described for Arm A) up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258902|NCT02622321|FG002|Participant Flow|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258903|NCT02622321|FG003|Participant Flow|Arm D: 1.5 mg/kg Emicizumab QW|Participants who were either: 1) Receiving episodic bypassing agents prior to study entry but were unable to enroll in Arms A or B; or 2) Receiving bypassing agent prophylaxis prior to study entry but were unable to enroll in Arm C, were enrolled in Arm D to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258904|NCT02622321|OG000|Outcome|Arm A: 1.5 mg/kg Emicizumab QW|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm A started to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 milligrams per kilogram (mg/kg) once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258905|NCT02622321|OG001|Outcome|Arm B (Control): No Prophylaxis|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm B continued with their prior episodic treatment regimen for the first 24 weeks of the study; they did not receive emicizumab prophylaxis during that time. After completing at least 24 weeks on study, participants in Arm B were allowed to switch to emicizumab prophylaxis (as described for Arm A) up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258906|NCT02622321|OG001|Outcome|Arm A (NIS): Previous Episodic Bypassing Agents|This arm includes data collected before entry into this study (assessed prospectively in a non-interventional study [NIS]) from Arm A participants who previously participated in NIS BH29768 (NCT02476942) and had received episodic bypassing agents during the NIS.
11258907|NCT02622321|OG000|Outcome|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258908|NCT02622321|OG001|Outcome|Arm C (NIS): Previous Prophylactic Bypassing Agents|This arm includes data collected before entry into this study (assessed prospectively in a non-interventional study [NIS]) from Arm C participants who previously participated in NIS BH29768 (NCT02476942) and had received prophylactic bypassing agents during the NIS.
11258909|NCT02622321|OG001|Outcome|Arm Cnis: Previous Prophylactic Bypassing Agents|This arm includes data collected before entry into this study (assessed prospectively in a non-interventional study [NIS]) from Arm C participants who previously participated in NIS BH29768 (NCT02476942) and had received prophylactic bypassing agents (rFVIIa or/and aPCC) during the NIS BH29768.
11258910|NCT02622321|OG002|Outcome|Arm B (Emi): 1.5 mg/kg Emicizumab QW|This arm includes Arm B participants who switched to emicizumab prophylaxis after having completed the first 24 weeks on study with no prophylaxis. After Week 24, emicizumab was administered at a loading dose of 3 mg/kg once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study.
11258911|NCT02622321|OG003|Outcome|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258912|NCT02622321|OG001|Outcome|Arm B (Emi): 1.5 mg/kg Emicizumab QW|This arm includes Arm B participants who switched to emicizumab prophylaxis after having completed the first 24 weeks on study with no prophylaxis. After Week 24, emicizumab was administered at a loading dose of 3 mg/kg once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study.
11258913|NCT02622321|OG002|Outcome|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258914|NCT02622321|OG003|Outcome|Arm D: 1.5 mg/kg Emicizumab QW|Participants who were either: 1) Receiving episodic bypassing agents prior to study entry but were unable to enroll in Arms A or B; or 2) Receiving bypassing agent prophylaxis prior to study entry but were unable to enroll in Arm C, were enrolled in Arm D to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258915|NCT02622321|OG004|Outcome|All Participants: 1.5 mg/kg Emicizumab QW|This analysis set included all enrolled participants on the study. For Arm B, it only all participants starting after Week 24 on study when they crossed over to first receive prophylactic treatment with emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
11258916|NCT02622321|OG004|Outcome|All Participants: 1.5 mg/kg Emicizumab QW|This analysis set included all enrolled participants on the study. For Arm B, it only included participants starting after Week 24 on study when they crossed over to first receive prophylactic treatment with emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
11258917|NCT02622321|OG000|Outcome|All Participants: 1.5 mg/kg Emicizumab QW|This analysis set included all enrolled participants on the study. For Arm B, it only included participants starting after Week 24 on study when they crossed over to first receive prophylactic treatment with emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Participants continued to receive bypassing agent therapy to treat breakthrough bleeds, with rFVIIa and/or aPCC.
11258918|NCT02622321|OG002|Outcome|Arm B (Emi): 1.5 mg/kg Emicizumab QW|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Data reported represents data collected during emicizumab treatment only.
11258919|NCT02622321|OG004|Outcome|Arm D: 1.5 mg/kg Emicizumab QW|Participants who were either: 1) Receiving episodic bypassing agents prior to study entry but were unable to enroll in Arms A or B; or 2) Receiving bypassing agent prophylaxis prior to study entry but were unable to enroll in Arm C, were enrolled in Arm D to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258920|NCT02622321|OG001|Outcome|Arm B (Emi): 1.5 mg/kg Emicizumab QW|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study.
11258921|NCT02622321|EG000|Reported Event|Arm A: 1.5 mg/kg Emicizumab QW|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm A started to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 milligrams per kilogram (mg/kg) once a week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11286594|NCT02890992|FG005|Participant Flow|Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130."
10820330|NCT00056862|BG001|Baseline|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
10820331|NCT00056862|BG002|Baseline|Total|Total of all reporting groups
11258922|NCT02622321|EG001|Reported Event|Arm B (Control): No Prophylaxis|Participants who were receiving episodic treatment with bypassing agents prior to study entry and were randomized to study Arm B continued with their prior episodic treatment regimen for the first 24 weeks of the study; they did not receive emicizumab prophylaxis during that time. The safety data reported here represents data collected from all Arm B participants during the first 24 weeks of 'no prophylaxis'; safety data from Arm B participants who switched to emicizumab after Week 24 are reported separately under Arm B (Emi): 1.5 mg/kg Emicizumab QW.
11258923|NCT02622321|EG002|Reported Event|Arm B (Emi): 1.5 mg/kg Emicizumab QW|This arm includes Arm B participants who switched to emicizumab prophylaxis after completing at least 24-week no prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg/week SC for the first 4 weeks (after at least 24 weeks) followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. Data reported represents data collected during emicizumab treatment only.
11258924|NCT02622321|EG003|Reported Event|Arm C: 1.5 mg/kg Emicizumab QW|Participants who were receiving prophylactic bypassing agents prior to study entry were enrolled in Arm C to receive prophylactic emicizumab. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258925|NCT02622321|EG004|Reported Event|Arm D: 1.5 mg/kg Emicizumab QW|Participants who were either: 1) Receiving episodic bypassing agents prior to study entry but were unable to enroll in Arms A or B; or 2) Receiving bypassing agent prophylaxis prior to study entry but were unable to enroll in Arm C, were enrolled in Arm D to receive emicizumab prophylaxis. Emicizumab was administered at a loading dose of 3 mg/kg QW SC for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC up to the end of study. Participants continued to receive bypassing agent therapy to treat any breakthrough bleeds.
11258926|NCT02622568|BG000|Baseline|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins + cryotherapy"
11258927|NCT02622568|BG001|Baseline|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11258928|NCT02622568|BG002|Baseline|Total|Total of all reporting groups
11258929|NCT02622568|FG000|Participant Flow|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11258930|NCT02622568|FG001|Participant Flow|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11258931|NCT02622568|OG000|Outcome|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins following cryotherapy"
11258932|NCT02622568|OG001|Outcome|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11286595|NCT02890992|FG006|Participant Flow|Cohort 4 - Alirocumab 150 mg Q4W: <50 kg|"Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.~Period 2: Participants with body weight < 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48."
11258933|NCT02622568|EG000|Reported Event|Cryotherapy + Veregen|"Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11258934|NCT02622568|EG001|Reported Event|Veregen Only|"Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.~Veregen or Sinecatechins"
11258935|NCT02622724|BG000|Baseline|FP-1201-lyo 10 μg|"FP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon beta-1a: Investigational drug"
11258936|NCT02622724|BG001|Baseline|Placebo|"Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Placebo: Placebo for investigational drug"
11258937|NCT02622724|BG002|Baseline|Total|Total of all reporting groups
11258938|NCT02622724|FG000|Participant Flow|FP-1201-lyo 10 μg|"FP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon beta-1a: Investigational drug"
11258939|NCT02622724|FG001|Participant Flow|Placebo|"Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Placebo: Placebo for investigational drug"
11258940|NCT02622724|OG000|Outcome|FP-1201-lyo 10 μg|"FP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon beta-1a: Investigational drug"
11258941|NCT02622724|OG001|Outcome|Placebo|"Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Placebo: Placebo for investigational drug"
11258942|NCT02622724|OG000|Outcome|FP-1201-lyo 10 μg|FP-1201-lyo 10 μg (Interferon beta-1a) for 6 days.
11258943|NCT02622724|OG001|Outcome|Placebo|Placebo for 6 days.
11258944|NCT02622724|OG000|Outcome|FP-1201-lyo 10 μg|FP-1201-lyo 10 μg (Interferon beta-1a) for 6 days
11258945|NCT02622724|OG001|Outcome|Placebo|Placebo for 6 days
11258946|NCT02622724|OG000|Outcome|Biomarker Responder|FP-1201-lyo 10 μg (Interferon beta-1a) for 6 days.
11258947|NCT02622724|OG001|Outcome|Biomarker Non-responder|FP-1201-lyo 10 μg (Interferon beta-1a) for 6 days.
11258948|NCT02622724|EG000|Reported Event|FP-1201-lyo 10 μg|"FP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon beta-1a: Investigational drug"
11258949|NCT02622724|EG001|Reported Event|Placebo|"Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Placebo: Placebo for investigational drug"
11258950|NCT02623218|BG000|Baseline|TBI-ACUP|"This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258951|NCT02623218|BG001|Baseline|TBI-SHAM|"This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258952|NCT02623218|BG002|Baseline|C-ACUP|"This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258953|NCT02623218|BG003|Baseline|C-SHAM|"This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258954|NCT02623218|BG004|Baseline|C-EX|"This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258955|NCT02623218|BG005|Baseline|Total|Total of all reporting groups
11258956|NCT02623218|FG000|Participant Flow|TBI-ACUP|"This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258957|NCT02623218|FG001|Participant Flow|TBI-SHAM|"This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258958|NCT02623218|FG002|Participant Flow|C-ACUP|"This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258959|NCT02623218|FG003|Participant Flow|C-SHAM|"This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258960|NCT02623218|FG004|Participant Flow|C-EX|"This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258961|NCT02623218|OG000|Outcome|TBI-ACUP|"This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258962|NCT02623218|OG001|Outcome|TBI-SHAM|"This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258963|NCT02623218|OG002|Outcome|C-ACUP|"This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258964|NCT02623218|OG003|Outcome|C-SHAM|"This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
11258965|NCT02623218|OG004|Outcome|C-EX|"This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258966|NCT02623218|EG000|Reported Event|TBI-ACUP|"This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258967|NCT02623218|EG001|Reported Event|TBI-SHAM|"This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
10969950|NCT00908037|OG001|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11258968|NCT02623218|EG002|Reported Event|C-ACUP|"This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258969|NCT02623218|EG003|Reported Event|C-SHAM|"This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.~Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin."
10820332|NCT00056862|FG000|Participant Flow|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
11258970|NCT02623218|EG004|Reported Event|C-EX|"This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group.~Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment."
11258971|NCT02623322|BG000|Baseline|Placebo|Participants received single-dose placebo by intravenous (IV) administration.
11258972|NCT02623322|BG001|Baseline|MHAA4549A 3600 mg|Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
11258973|NCT02623322|BG002|Baseline|MHAA4549A 8400 mg|Participants received single-dose MHAA4549A, 8400 mg, by IV administration.
11258974|NCT02623322|BG003|Baseline|Total|Total of all reporting groups
11258975|NCT02623322|FG000|Participant Flow|Placebo|Participants received single-dose placebo by intravenous (IV) administration.
11258976|NCT02623322|FG001|Participant Flow|MHAA4549A 3600 mg|Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
11258977|NCT02623322|FG002|Participant Flow|MHAA4549A 8400 mg|Participants received single-dose MHAA4549A, 8400 mg, by IV administration.
11258978|NCT02623322|OG000|Outcome|Placebo|Participants received single-dose placebo by intravenous (IV) administration.
11258979|NCT02623322|OG001|Outcome|MHAA4549A 3600 mg|Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
11258980|NCT02623322|OG002|Outcome|MHAA4549A 8400 mg|Participants received single-dose MHAA4549A, 8400 mg, by IV administration.
11258981|NCT02623322|OG000|Outcome|MHAA4549A 3600 mg|Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
11258982|NCT02623322|OG001|Outcome|MHAA4549A 8400 mg|Participants received single-dose MHAA4549A, 8400 mg, by IV administration.
11258983|NCT02623322|EG000|Reported Event|Placebo|Participants received single-dose placebo by intravenous (IV) administration.
11258984|NCT02623322|EG001|Reported Event|MHAA4549A 3600 mg|Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
11258985|NCT02623322|EG002|Reported Event|MHAA4549A 8400 mg|Participants received single-dose MHAA4549A, 8400 mg, by IV administration.
11258986|NCT02623335|BG000|Baseline|QPL (Question Prompt List) Brochure|"Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.~QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon."
11258987|NCT02623335|BG001|Baseline|Usual Care|The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
11258988|NCT02623335|BG002|Baseline|Total|Total of all reporting groups
11258989|NCT02623335|FG000|Participant Flow|QPL (Question Prompt List) Brochure|"Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.~QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon."
11258990|NCT02623335|FG001|Participant Flow|Usual Care|The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
11258991|NCT02623335|OG000|Outcome|QPL (Question Prompt List) Brochure|"Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.~QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon."
11258992|NCT02623335|OG001|Outcome|Usual Care|The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
11258993|NCT02623335|EG000|Reported Event|QPL (Question Prompt List) Brochure|"Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.~QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon."
11258994|NCT02623335|EG001|Reported Event|Usual Care|The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
11258995|NCT02623348|BG000|Baseline|Pedometer|Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.
11258996|NCT02623348|BG001|Baseline|Usual Care|Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
11258997|NCT02623348|BG002|Baseline|Total|Total of all reporting groups
11258998|NCT02623348|FG000|Participant Flow|Pedometer|Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.
11258999|NCT02623348|FG001|Participant Flow|Usual Care|Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
11259000|NCT02623348|OG000|Outcome|Pedometer|Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.
11259001|NCT02623348|OG001|Outcome|Usual Care|Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
11259002|NCT02623348|EG000|Reported Event|Pedometer|Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.
11259003|NCT02623348|EG001|Reported Event|Usual Care|Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
11259004|NCT02623361|BG000|Baseline|Sham|Sham Block: Sham Block by saline injection
11259005|NCT02623361|BG001|Baseline|FICB|Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
11259006|NCT02623361|BG002|Baseline|Total|Total of all reporting groups
11259007|NCT02623361|FG000|Participant Flow|Sham|Sham Block: Sham Block by saline injection
11259008|NCT02623361|FG001|Participant Flow|FICB|Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
11259009|NCT02623361|OG000|Outcome|Sham|Sham Block: Sham Block by saline injection
11259010|NCT02623361|OG001|Outcome|FICB|Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
11259011|NCT02623361|EG000|Reported Event|Sham|Sham Block: Sham Block by saline injection
11259012|NCT02623361|EG001|Reported Event|FICB|Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection
11259013|NCT02623803|BG000|Baseline|Treatment Group|"lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.~Lidocaine"
11259014|NCT02623803|BG001|Baseline|Control Group|"placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.~Placebo D5W"
11259015|NCT02623803|BG002|Baseline|Total|Total of all reporting groups
11259016|NCT02623803|FG000|Participant Flow|Treatment Group|"lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.~Lidocaine"
11259017|NCT02623803|FG001|Participant Flow|Control Group|"placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.~Placebo D5W"
11259018|NCT02623803|OG000|Outcome|Treatment Group|"lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.~Lidocaine"
11259019|NCT02623803|OG001|Outcome|Control Group|"placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.~Placebo D5W"
11259020|NCT02623803|EG000|Reported Event|Treatment Group|"lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.~Lidocaine"
11259021|NCT02623803|EG001|Reported Event|Control Group|"placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.~Placebo D5W"
11259022|NCT02623829|BG000|Baseline|Botulinum Toxin|subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
11259023|NCT02623829|BG001|Baseline|Saline|subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
11259024|NCT02623829|BG002|Baseline|Total|Total of all reporting groups
11259025|NCT02623829|FG000|Participant Flow|Botulinum Toxin|subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
11259026|NCT02623829|FG001|Participant Flow|Saline|subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
11259027|NCT02623829|OG000|Outcome|Botulinum Toxin|subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
11259028|NCT02623829|OG001|Outcome|Saline|subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
11259029|NCT02623829|EG000|Reported Event|Botulinum Toxin|subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds
11259030|NCT02623829|EG001|Reported Event|Saline|subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
11286596|NCT02890992|FG007|Participant Flow|Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg|"Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.~Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48."
11286597|NCT02890992|OG000|Outcome|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
11286598|NCT02890992|OG001|Outcome|Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
11286599|NCT02890992|OG002|Outcome|Cohort 2 - Alirocumab 40 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
11286600|NCT02890992|OG003|Outcome|Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
11286601|NCT02890992|OG004|Outcome|Cohort 3 - Alirocumab 75 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
11286602|NCT02890992|OG005|Outcome|Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
11286603|NCT02890992|OG006|Outcome|Cohort 4 - Alirocumab 150 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
11286604|NCT02890992|OG007|Outcome|Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
11286605|NCT02890992|OG000|Outcome|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.
11286606|NCT02890992|OG000|Outcome|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram (mg) administered Q2W up to 8 weeks added to LMT.
11259031|NCT02623855|BG000|Baseline|Park Prescription|"Park prescription, pedometry.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry."
11259032|NCT02623855|BG001|Baseline|Park Prescription and Family Outings|"Park prescription, pedometry, case management and 3 weekly family outings.~Family outings: Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry.~Case Management: Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary."
11259033|NCT02623855|BG002|Baseline|Total|Total of all reporting groups
11259034|NCT02623855|FG000|Participant Flow|Park Prescription|"Park prescription, pedometry.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry."
11259035|NCT02623855|FG001|Participant Flow|Park Prescription and Family Outings|"Park prescription, pedometry, case management and 3 weekly family outings.~Family outings: Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry.~Case Management: Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary."
11259036|NCT02623855|OG000|Outcome|Park Prescription|"Park prescription, pedometry.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry."
11259037|NCT02623855|OG001|Outcome|Park Prescription and Family Outings|"Park prescription, pedometry, case management and 3 weekly family outings.~Family outings: Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry.~Case Management: Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary."
11259038|NCT02623855|EG000|Reported Event|Park Prescription|"Park prescription, pedometry.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry."
11259039|NCT02623855|EG001|Reported Event|Park Prescription and Family Outings|"Park prescription, pedometry, case management and 3 weekly family outings.~Family outings: Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.~Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.~Pedometry: Participants will record their daily pedometry.~Case Management: Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary."
11259040|NCT02624050|BG000|Baseline|Methohexital|"Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.~Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259041|NCT02624050|BG001|Baseline|Propofol|"Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.~Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259042|NCT02624050|BG002|Baseline|Total|Total of all reporting groups
11259043|NCT02624050|FG000|Participant Flow|Methohexital|"Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.~Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259044|NCT02624050|FG001|Participant Flow|Propofol|"Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.~Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259045|NCT02624050|OG000|Outcome|Methohexital|"Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.~Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259046|NCT02624050|OG001|Outcome|Propofol|"Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.~Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259047|NCT02624050|EG000|Reported Event|Propofol|"Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.~Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259048|NCT02624050|EG001|Reported Event|Methohexital|"Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.~Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event."
11259049|NCT02624180|BG000|Baseline|Colchicine|"Colchicine 0.6 mg daily by mouth~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11259050|NCT02624180|BG001|Baseline|Placebo|"Placebo for colchicine 1 tablet by mouth daily~Placebo: A substance containing no medication"
11259051|NCT02624180|BG002|Baseline|Total|Total of all reporting groups
11259052|NCT02624180|FG000|Participant Flow|Colchicine|"Colchicine 0.6 mg daily by mouth~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11259053|NCT02624180|FG001|Participant Flow|Placebo|"Placebo for colchicine 1 tablet by mouth daily~Placebo: A substance containing no medication"
11259054|NCT02624180|OG000|Outcome|Colchicine|"Colchicine 0.6 mg daily by mouth~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11259055|NCT02624180|OG001|Outcome|Placebo|"Placebo for colchicine 1 tablet by mouth daily~Placebo: A substance containing no medication"
11259056|NCT02624180|EG000|Reported Event|Colchicine|"Colchicine 0.6 mg daily by mouth~Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease."
11259057|NCT02624180|EG001|Reported Event|Placebo|"Placebo for colchicine 1 tablet by mouth daily~Placebo: A substance containing no medication"
11259058|NCT02624284|BG000|Baseline|Sham Dose|"Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area.~Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS."
11259059|NCT02624284|BG001|Baseline|1mA Dose|"Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259060|NCT02624284|BG002|Baseline|2 mA Dose|"Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259061|NCT02624284|BG003|Baseline|Total|Total of all reporting groups
11259062|NCT02624284|FG000|Participant Flow|Sham Dose|"Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area.~Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS."
11259063|NCT02624284|FG001|Participant Flow|1mA Dose|"Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11286607|NCT02890992|OG000|Outcome|Cohort 4 - Alirocumab 150 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
11286608|NCT02890992|OG001|Outcome|Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
11259064|NCT02624284|FG002|Participant Flow|2 mA Dose|"Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259065|NCT02624284|OG000|Outcome|Sham Dose|"Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area.~Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS."
11259066|NCT02624284|OG001|Outcome|1mA Dose|"Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259067|NCT02624284|OG002|Outcome|2 mA Dose|"Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259068|NCT02624284|EG000|Reported Event|Sham Dose|"Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area.~Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS."
11259069|NCT02624284|EG001|Reported Event|1mA Dose|"Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259070|NCT02624284|EG002|Reported Event|2 mA Dose|"Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).~transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system)."
11259071|NCT02624375|BG000|Baseline|Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)|We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
10969951|NCT00908037|OG005|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
11259072|NCT02624375|FG000|Participant Flow|Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)|We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
11259073|NCT02624375|OG000|Outcome|Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)|We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
11259074|NCT02624375|EG000|Reported Event|Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)|We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
11259075|NCT02624492|BG000|Baseline|BI 836826 25 Milligram (mg) + GemOx|Patients were administered (intravenous infusion) BI 836826 25 mg on Day 8 and GemOx (gemcitabine 1000 mg/metre square (m^2) plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259076|NCT02624492|BG001|Baseline|BI 836826 50 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 50 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259077|NCT02624492|BG002|Baseline|BI 836826 100 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 100 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259078|NCT02624492|BG003|Baseline|Total|Total of all reporting groups
11259079|NCT02624492|FG000|Participant Flow|BI 836826 25 Milligram (mg) + GemOx|Patients were administered (intravenous infusion) BI 836826 25 mg on Day 8 and GemOx (gemcitabine 1000 mg/metre square (m^2) plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259080|NCT02624492|FG001|Participant Flow|BI 836826 50 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 50 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259081|NCT02624492|FG002|Participant Flow|BI 836826 100 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 100 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259082|NCT02624492|OG000|Outcome|BI 836826 25 Milligram (mg) + GemOx|Patients were administered (intravenous infusion) BI 836826 25 mg on Day 8 and GemOx (gemcitabine 1000 mg/metre square (m^2) plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259083|NCT02624492|OG001|Outcome|BI 836826 50 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 50 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259084|NCT02624492|OG002|Outcome|BI 836826 100 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 100 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259085|NCT02624492|EG000|Reported Event|BI 836826 25 Milligram (mg) + GemOx|Patients were administered (intravenous infusion) BI 836826 25 mg on Day 8 and GemOx (gemcitabine 1000 mg/metre square (m^2) plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259086|NCT02624492|EG001|Reported Event|BI 836826 50 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 50 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259087|NCT02624492|EG002|Reported Event|BI 836826 100 mg + GemOx|Patients were administered (intravenous infusion) BI 836826 100 mg on Day 8 and GemOx (gemcitabine 1000 mg/m^2 plus oxaliplatin 100 mg/m^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days.
11259088|NCT02624687|BG000|Baseline|Intervention|"These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction.~Decreasing Sedentary Behavior"
11259089|NCT02624687|BG001|Baseline|Control|"These subjects will receive no intervention.~No intervention"
11259090|NCT02624687|BG002|Baseline|Total|Total of all reporting groups
11259091|NCT02624687|FG000|Participant Flow|Intervention|"These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction.~Decreasing Sedentary Behavior"
11259092|NCT02624687|FG001|Participant Flow|Control|"These subjects will receive no intervention.~No intervention"
11259093|NCT02624687|OG000|Outcome|Intervention|"These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction.~Decreasing Sedentary Behavior"
11259094|NCT02624687|OG001|Outcome|Control|"These subjects will receive no intervention.~No intervention"
11259095|NCT02624687|EG000|Reported Event|Intervention|"These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction.~Decreasing Sedentary Behavior"
11259096|NCT02624687|EG001|Reported Event|Control|"These subjects will receive no intervention.~No intervention"
11286609|NCT02890992|OG004|Outcome|Cohort 3 - Alirocumab 75 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to Week 8 added to LMT.
11259097|NCT02624700|BG000|Baseline|A: Pemetrexed + Sorafenib|"Pemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle~Experimental Arm A: Pemetrexed: Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm A: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg."
11259098|NCT02624700|BG001|Baseline|B: Pemetrexed + Sorafenib|"Pemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21 days of each cycle.~Experimental Arm B: Pemetrexed: Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm B: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg."
11259099|NCT02624700|BG002|Baseline|Total|Total of all reporting groups
11259100|NCT02624700|FG000|Participant Flow|A: Pemetrexed + Sorafenib|"Pemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle~Experimental Arm A: Pemetrexed: Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm A: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg."
11259101|NCT02624700|FG001|Participant Flow|B: Pemetrexed + Sorafenib|"Pemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21-days of each cycle.~Experimental Arm B: Pemetrexed: Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm B: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg."
11259102|NCT02624700|OG000|Outcome|A: Pemetrexed + Sorafenib|"Pemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle~Experimental Arm A: Pemetrexed: Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm A: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg."
11259103|NCT02624700|OG001|Outcome|B: Pemetrexed + Sorafenib|"Pemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21 days of each cycle.~Experimental Arm B: Pemetrexed: Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm B: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg."
11259104|NCT02624700|OG000|Outcome|A: Pemetrexed + Sorafenib|Pemetrexed 500mg/m2 IV Day 1 + Sorafenib 400mg PO BID Days 1-5, Every 14 Days
11259105|NCT02624700|OG001|Outcome|B: Pemetrexed + Sorafenib|Pemetrexed 375mg/m2 IV Day 1 + Sorafenib 200mg PO BID Days 1-5, Every 21 Days
11259106|NCT02624700|EG000|Reported Event|A: Pemetrexed + Sorafenib|"Pemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle~Experimental Arm A: Pemetrexed: Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm A: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg."
11259107|NCT02624700|EG001|Reported Event|B: Pemetrexed + Sorafenib|"Pemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21 days of each cycle.~Experimental Arm B: Pemetrexed: Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.~Experimental Arm B: Sorafenib: Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg."
11259108|NCT02624713|BG000|Baseline|Prospective Study|obesity treatment: 1.Parents' education groups for nutrition and healthy behavior with a dietitian and a social worker every 2 weeks for 5 months, for a total of 10 meetings. This part of the intervention aimed at providing parents with effective tools for modification of lifestyle and the family environment. 2. Children's individual therapy consisted of 6 individual meetings with a family physician, a physical therapist specializing in children.
11259109|NCT02624713|BG001|Baseline|Retrospective Random Controlled Research|"Retrospective Random Controlled Research~The research group - families that have completed an intervention program of Active Maccabi ,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires. Approximately 66 families.~The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), ."
11259110|NCT02624713|BG002|Baseline|Total|Total of all reporting groups
11259111|NCT02624713|FG000|Participant Flow|Prospective Study|"The Prospective study had only an intervention group. The intervention group included families who participated in the Maccabi Active program in 2015 in the northern district. The parameters were measured in three different times. Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (time 3). Anthropometric measurements were taken and a Cheat 26 questionnaire was given to each child in the families. The parents filled personal details and a questionnaire for mapping the family eating habits (FEAHQ-33)."
11286610|NCT02890992|EG000|Reported Event|Cohort 1 - Alirocumab 30 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to the switch of dosage added to LMT.
11286611|NCT02890992|EG001|Reported Event|Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to the switch of dosage added to LMT.
11259112|NCT02624713|FG001|Participant Flow|Retrospective Controlled Research|"Retrospective Controlled Research The research group - families that have completed an intervention program of Active Maccabi Northern Region, Israel,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires..~The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in correlation with the child in the intervention group.~All participants from both the control and research groups were evaluated at the follow-up and the data collected at follow-up is being reported collectively for the Retrospective Controlled Research branch."
11259113|NCT02624713|OG000|Outcome|Obesity Treatment|"Retrospective Random Controlled Research~The research group - families that have completed an intervention program of Active Maccabi ,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires. Approximately 66 families.~The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), .~obesity treatment: 1.Parents' education groups for nutrition and healthy behavior with a dietician and a social worker every 2 weeks for5 months, for a total of 10 meetings. This part of the intervention aimed at providing parents with effective tools for modification of lifestyle and the family environment. 2. Children's individual therapy consisted of 6 individual meetings with a family physician, a physical therapist specializing in children's physi"
11259114|NCT02624713|OG001|Outcome|Prospective Research|Forty-two families took part in this study, with 78 children: 48 overweight children and 30 siblings. The parameters were measured in three different times. Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (time 3). Anthropometric measurements were taken and the Eat 26 questionnaire was given to each child in the families. The parents filled personal details and answered questions regarding the family eating habits.
11259115|NCT02624713|OG000|Outcome|Prospective Research|Forty-two families (one parent in each family) took part in this study, with 78 children: 48 overweight children and 30 siblings. The parameters were measured in three different times. Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (time 3). Anthropometric measurements were taken and the Eat 26 questionnaire was given to each child in the families. The parents filled personal details and answered questions regarding the family eating habits.
11259116|NCT02624713|EG000|Reported Event|Prospective Study|"Obesity research~Parents' education groups for nutrition and healthy behavior with a dietitian and a social worker every 2 weeks for 5 months, for a total of 10 meetings. This part of the intervention aimed at providing parents with effective tools for modification of lifestyle and the family environment.~Children's individual therapy consisted of 6 individual meetings with a family physician, a physical therapist specializing in children's physi"
11259117|NCT02624713|EG001|Reported Event|Retrospective Random Controlled Research|"Retrospective Random Controlled Research~The research group - families that have completed an intervention program of Active Maccabi ,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires. Approximately 66 families.~The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years)"
11259118|NCT02624791|BG000|Baseline|Contact Lens Sequence|Order in which each participant received the 3 lens conditions
11259119|NCT02624791|FG000|Participant Flow|Lens Sequence 1|None; Sphere; Toric
11259120|NCT02624791|FG001|Participant Flow|Lens Sequence 2|None; Toric; Sphere
11259121|NCT02624791|FG002|Participant Flow|Lens Sequence 3|Sphere; None; Toric
11259122|NCT02624791|FG003|Participant Flow|Lens Sequence 4|Sphere; Toric; None
11259123|NCT02624791|FG004|Participant Flow|Lens Sequence 5|Toric; None; Sphere
11259124|NCT02624791|FG005|Participant Flow|Lens Sequence 6|Toric; Sphere; None
11259125|NCT02624791|OG000|Outcome|Contact Lens Rx|All study participants
11259126|NCT02624791|EG000|Reported Event|Contact Lens Rx|None; Sphere; Toric
11259127|NCT02624843|BG000|Baseline|Benzyl Alcohol Lotion 5%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Benzyl Alcohol Lotion 5%: White topical lotion"
11259128|NCT02624843|BG001|Baseline|Ulesfia (Benzyl Alcohol Lotion 5%)|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Ulesfia (benzyl alcohol lotion) 5%: White topical lotion"
11259129|NCT02624843|BG002|Baseline|Vehicle Placebo Lotion 0%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Placebo: White topical lotion"
11259130|NCT02624843|BG003|Baseline|Total|Total of all reporting groups
11259131|NCT02624843|FG000|Participant Flow|Benzyl Alcohol Lotion 5%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Benzyl Alcohol Lotion 5%: White topical lotion"
11259132|NCT02624843|FG001|Participant Flow|Ulesfia (Benzyl Alcohol Lotion 5%)|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Ulesfia (benzyl alcohol lotion) 5%: White topical lotion"
11259133|NCT02624843|FG002|Participant Flow|Vehicle Placebo Lotion 0%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Placebo: White topical lotion"
11259134|NCT02624843|OG000|Outcome|Benzyl Alcohol Lotion 5%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Benzyl Alcohol Lotion 5%: White topical lotion"
11259135|NCT02624843|OG001|Outcome|Ulesfia (Benzyl Alcohol Lotion 5%)|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Ulesfia (benzyl alcohol lotion) 5%: White topical lotion"
11259136|NCT02624843|OG002|Outcome|Vehicle Placebo Lotion 0%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Placebo: White topical lotion"
11259137|NCT02624843|EG000|Reported Event|Benzyl Alcohol Lotion 5%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Benzyl Alcohol Lotion 5%: White topical lotion"
11259138|NCT02624843|EG001|Reported Event|Ulesfia (Benzyl Alcohol Lotion 5%)|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Ulesfia (benzyl alcohol lotion) 5%: White topical lotion"
11259139|NCT02624843|EG002|Reported Event|Vehicle Placebo Lotion 0%|"Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.~Placebo: White topical lotion"
11259140|NCT02624986|BG000|Baseline|DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259141|NCT02624986|BG001|Baseline|DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259142|NCT02624986|BG002|Baseline|DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259143|NCT02624986|BG003|Baseline|DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m^2) IV for 6 cycles (1 cycle = 28 days).
11259144|NCT02624986|BG004|Baseline|DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m^2 IV for 6 cycles (1 cycle = 28 days).
11259145|NCT02624986|BG005|Baseline|FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259146|NCT02624986|BG006|Baseline|FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259147|NCT02624986|BG007|Baseline|FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
11259148|NCT02624986|BG008|Baseline|Total|Total of all reporting groups
11259149|NCT02624986|FG000|Participant Flow|DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259150|NCT02624986|FG001|Participant Flow|DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259151|NCT02624986|FG002|Participant Flow|DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259152|NCT02624986|FG003|Participant Flow|DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m^2) IV for 6 cycles (1 cycle = 28 days).
11259153|NCT02624986|FG004|Participant Flow|DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m^2 IV for 6 cycles (1 cycle = 28 days).
11259154|NCT02624986|FG005|Participant Flow|FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259155|NCT02624986|FG006|Participant Flow|FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259156|NCT02624986|FG007|Participant Flow|FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
11259157|NCT02624986|OG000|Outcome|DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259158|NCT02624986|OG001|Outcome|DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259159|NCT02624986|OG002|Outcome|DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259160|NCT02624986|OG003|Outcome|DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m^2) IV for 6 cycles (1 cycle = 28 days).
11259161|NCT02624986|OG004|Outcome|DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m^2 IV for 6 cycles (1 cycle = 28 days).
11259162|NCT02624986|OG005|Outcome|FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259163|NCT02624986|OG006|Outcome|FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259164|NCT02624986|OG007|Outcome|FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
11259165|NCT02624986|OG000|Outcome|DLBCL/FL Combined: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259166|NCT02624986|OG001|Outcome|DLBCL/FL Combined: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259167|NCT02624986|OG000|Outcome|DLBCL/FL: Idasanutlin 100/150/200 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma received induction treatment with idasanutlin 100 milligrams (mg), 150 mg, or 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259168|NCT02624986|OG000|Outcome|DLBCL Combined: Idasanutlin 150/200 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) received induction treatment with idasanutlin 150 mg or 200 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m^2) IV for 6 cycles (1 cycle = 28 days).
11259169|NCT02624986|EG000|Reported Event|DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259170|NCT02624986|EG001|Reported Event|DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259171|NCT02624986|EG002|Reported Event|DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259172|NCT02624986|EG003|Reported Event|DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m^2) IV for 6 cycles (1 cycle = 28 days).
11259173|NCT02624986|EG004|Reported Event|DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2|Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m^2 IV for 6 cycles (1 cycle = 28 days).
11259174|NCT02624986|EG005|Reported Event|FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
11259175|NCT02624986|EG006|Reported Event|FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
11259176|NCT02624986|EG007|Reported Event|FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg|Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
11259177|NCT02625181|BG000|Baseline|Baseline Measurement|No recommendations were provided for PONV prophylaxis.
11259178|NCT02625181|BG001|Baseline|CDS Email Recommendations|Automated recommendations on PONV prophylaxis provided by email only.
11259179|NCT02625181|BG002|Baseline|CDS Email + Real TIme Recommenations|Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
11259180|NCT02625181|BG003|Baseline|Total|Total of all reporting groups
11259181|NCT02625181|FG000|Participant Flow|Baseline Measurement|No recommendations were provided for PONV prophylaxis.
11259182|NCT02625181|FG001|Participant Flow|CDS Email Recommendations|Automated recommendations on PONV prophylaxis provided by email only.
11259183|NCT02625181|FG002|Participant Flow|CDS Email + Real TIme Recommenations|Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
11259184|NCT02625181|OG000|Outcome|Baseline Measurement|No recommendations were provided for PONV prophylaxis.
11259185|NCT02625181|OG001|Outcome|CDS Email Recommendations|Automated recommendations on PONV prophylaxis provided by email only.
11259186|NCT02625181|OG002|Outcome|CDS Email + Real TIme Recommenations|Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
11259187|NCT02625181|EG000|Reported Event|PONV Clinical Decision Support System|"Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.~Automated recommendation at the start of the case: The first notification is the main notification that informs the anesthesia providers at the start of anesthesia of the risk score for that individual patient and the recommended number of prophylactic interventions. The notification occurs within the anesthesia information management system (AIMS)~Preoperative recommendations: by email: A recommendation on PONV prophylaxis to anesthesia providers through email."
11259188|NCT02625207|BG000|Baseline|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259189|NCT02625207|BG001|Baseline|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259190|NCT02625207|BG002|Baseline|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259191|NCT02625207|BG003|Baseline|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259192|NCT02625207|BG004|Baseline|Total|Total of all reporting groups
11259193|NCT02625207|FG000|Participant Flow|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 milligram (mg) tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259194|NCT02625207|FG001|Participant Flow|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259195|NCT02625207|FG002|Participant Flow|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259196|NCT02625207|FG003|Participant Flow|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259197|NCT02625207|OG000|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259198|NCT02625207|OG001|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259199|NCT02625207|OG002|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259200|NCT02625207|OG003|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259201|NCT02625207|OG000|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
11259202|NCT02625207|OG001|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259203|NCT02625207|OG000|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
11259204|NCT02625207|OG001|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
11259205|NCT02625207|EG000|Reported Event|Part 1: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259206|NCT02625207|EG001|Reported Event|Part 1: Cohort 2- One CYP3A5*1 Allele|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259207|NCT02625207|EG002|Reported Event|Part 1: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259208|NCT02625207|EG003|Reported Event|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
11259209|NCT02625207|EG004|Reported Event|Part 2: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
11259210|NCT02625207|EG005|Reported Event|Part 2: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
11259211|NCT02625220|BG000|Baseline|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
11259212|NCT02625220|FG000|Participant Flow|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
11259213|NCT02625220|OG000|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
11259214|NCT02625220|EG000|Reported Event|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
11259215|NCT02625233|BG000|Baseline|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
11259216|NCT02625233|BG001|Baseline|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
11259217|NCT02625233|BG002|Baseline|Total|Total of all reporting groups
11259218|NCT02625233|FG000|Participant Flow|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
11259219|NCT02625233|FG001|Participant Flow|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
11259220|NCT02625233|OG000|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens througout the entire duration of the study.
11259221|NCT02625233|OG001|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
11259222|NCT02625233|EG000|Reported Event|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
11259223|NCT02625233|EG001|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
11259224|NCT02625259|BG000|Baseline|Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets|TAK-117 9*100 mg, capsules (current clinical trial material [CTM]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3*300 mg, tablets (new clinical trial material [NTM]), orally, once on Day 15 (second intervention).
11259225|NCT02625259|BG001|Baseline|Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
11259226|NCT02625259|BG002|Baseline|Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
11259227|NCT02625259|BG003|Baseline|Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
11259228|NCT02625259|BG004|Baseline|Part-3: TAK-117 900 mg + Lansoprazole 30 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
11259229|NCT02625259|BG005|Baseline|Total|Total of all reporting groups
11259230|NCT02625259|FG000|Participant Flow|Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets|TAK-117 9*100 mg, capsules (current clinical trial material [CTM]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3*300 mg, tablets (new clinical trial material [NTM]), orally, once on Day 15 (second intervention).
11259231|NCT02625259|FG001|Participant Flow|Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
11259232|NCT02625259|FG002|Participant Flow|Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
11259233|NCT02625259|FG003|Participant Flow|Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
11259234|NCT02625259|FG004|Participant Flow|Part-3: TAK-117 900 mg + Lansoprazole 30 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
11259235|NCT02625259|OG000|Outcome|Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
11259236|NCT02625259|OG001|Outcome|Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
11259237|NCT02625259|OG002|Outcome|Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
11259238|NCT02625259|OG003|Outcome|Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
11259239|NCT02625259|OG004|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets)|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
11259240|NCT02625259|OG005|Outcome|Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally once on Day 15.
11259241|NCT02625259|EG000|Reported Event|Part-1: TAK-117 900 mg Capsules|TAK-117 9*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
11259242|NCT02625259|EG001|Reported Event|Part-1: TAK-117 900 mg Tablets|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
11259243|NCT02625259|EG002|Reported Event|Part-2: TAK-117 600 mg Fasted|TAK-117 2*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
11259244|NCT02625259|EG003|Reported Event|Part-2: TAK-117 600 mg Fed|TAK-117 2*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
11259245|NCT02625259|EG004|Reported Event|Part-3: TAK-117 900 mg|TAK-117 3*300 mg, tablets (NTM), orally, once on Day 1.
11259246|NCT02625259|EG005|Reported Event|Part-3: Lansoprazole 30 mg|Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 14.
11259247|NCT02625259|EG006|Reported Event|Part 3: Lansoprazole 30 mg + TAK-117 900 mg|Lansoprazole 30 mg, capsule, orally, once daily on Day 15 along with TAK-117 3*300 mg, tablets (NTM), orally, once on Day 15.
11259248|NCT02625298|BG000|Baseline|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
11259249|NCT02625298|BG001|Baseline|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
11259250|NCT02625298|BG002|Baseline|Total|Total of all reporting groups
11259251|NCT02625298|FG000|Participant Flow|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
11259252|NCT02625298|FG001|Participant Flow|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
11259253|NCT02625298|OG000|Outcome|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
11259254|NCT02625298|OG001|Outcome|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
11259255|NCT02625298|OG000|Outcome|ProRoot MTA|Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
11259256|NCT02625298|OG001|Outcome|MTA+ Cercamed|Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
11259257|NCT02625298|EG000|Reported Event|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment~ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
11259258|NCT02625298|EG001|Reported Event|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment~MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
11259259|NCT02625402|BG000|Baseline|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11259260|NCT02625402|BG001|Baseline|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11259261|NCT02625402|BG002|Baseline|Total|Total of all reporting groups
11259262|NCT02625402|FG000|Participant Flow|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11259263|NCT02625402|FG001|Participant Flow|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11259264|NCT02625402|OG000|Outcome|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11259265|NCT02625402|OG001|Outcome|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11259266|NCT02625402|EG000|Reported Event|Interactive Decision Aid|"Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise~Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11259267|NCT02625402|EG001|Reported Event|Video Decision Aid|"Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog~Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11286612|NCT02890992|EG002|Reported Event|Cohort 2 - Alirocumab 40 mg Q2W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to the switch of dosage added to LMT.
11286613|NCT02890992|EG003|Reported Event|Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to the switch of dosage added to LMT.
11259268|NCT02625428|BG000|Baseline|For Cause|"For cause biopsy to evaluate a recent rise in serum creatinine.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259269|NCT02625428|BG001|Baseline|Surveillance|"Surveillance biopsy done after transplant mostly looking for subclinical rejection.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259270|NCT02625428|BG002|Baseline|Total|Total of all reporting groups
11259271|NCT02625428|FG000|Participant Flow|For Cause|"For cause biopsy to evaluate a recent rise in serum creatinine.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259272|NCT02625428|FG001|Participant Flow|Surveillance|"Surveillance biopsy done after transplant mostly looking for subclinical rejection.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259273|NCT02625428|OG000|Outcome|For Cause|"For cause biopsy to evaluate a recent rise in serum creatinine.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259274|NCT02625428|OG001|Outcome|Surveillance|"Surveillance biopsy done after transplant mostly looking for subclinical rejection.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259275|NCT02625428|EG000|Reported Event|For Cause|"For cause biopsy to evaluate a recent rise in serum creatinine.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259276|NCT02625428|EG001|Reported Event|Surveillance|"Surveillance biopsy done after transplant mostly looking for subclinical rejection.~Optison~Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.~Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure."
11259277|NCT02625545|BG000|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure.
11259278|NCT02625545|FG000|Participant Flow|UroLift System Procedure|"All eligible,enrolled subjects will undergo a UroLift procedure~UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH"
11259279|NCT02625545|OG000|Outcome|UroLift System Procedure|"All eligible,enrolled subjects will undergo a UroLift procedure~UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH"
11259280|NCT02625545|EG000|Reported Event|UroLift System Procedure|"All eligible,enrolled subjects will undergo a UroLift procedure~UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH"
11259281|NCT02625571|BG000|Baseline|Intervention|Phase-based treatment of sexual behavior problems of children
11259282|NCT02625571|FG000|Participant Flow|Intervention|Phase-based treatment of sexual behavior problems of children
11259283|NCT02625571|OG000|Outcome|Intervention|Phase-based treatment of sexual behavior problems of children
11259284|NCT02625571|EG000|Reported Event|Intervention|Phase-based treatment of sexual behavior problems of children
11259285|NCT02625623|BG000|Baseline|Physician Choice Chemotherapy + Best Supportive Care (BSC)|Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259286|NCT02625623|BG001|Baseline|Avelumab + BSC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259287|NCT02625623|BG002|Baseline|Total|Total of all reporting groups
10820333|NCT00056862|FG001|Participant Flow|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
11259288|NCT02625623|FG000|Participant Flow|Physician Choice Chemotherapy + Best Supportive Care (BSC)|Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259289|NCT02625623|FG001|Participant Flow|Avelumab + BSC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259290|NCT02625623|OG000|Outcome|Physician Choice Chemotherapy + Best Supportive Care (BSC)|Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259291|NCT02625623|OG001|Outcome|Avelumab + BSC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259292|NCT02625623|OG001|Outcome|Avelumab + BSC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259293|NCT02625623|OG001|Outcome|Avelumab + SC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259294|NCT02625623|EG000|Reported Event|Physician Choice Chemotherapy + Best Supportive Care (BSC)|Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259295|NCT02625623|EG001|Reported Event|Avelumab + BSC|Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion.
11259296|NCT02625844|BG000|Baseline|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
11259297|NCT02625844|FG000|Participant Flow|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
11259298|NCT02625844|OG000|Outcome|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
11259299|NCT02625844|EG000|Reported Event|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
11259300|NCT02625909|BG000|Baseline|Drug: Sofosbuvir/Velpatasvir (SOF/VEL) for 6 Weeks|"Open-label sofosbuvir/velpatasvir (SOF/VEL) 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the short treatment duration arm (A) for 6 weeks.~SOF/VEL for 6 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration)."
11259301|NCT02625909|BG001|Baseline|Drug: Sofosbuvir/Velpatasvir (SOF/VEL) for 12 Weeks|"Open-label sofosbuvir/velpatasvir (SOF/VEL) 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the standard treatment duration arm (B) for 12 weeks.~SOF/VEL for 12 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration)."
11259302|NCT02625909|BG002|Baseline|Total|Total of all reporting groups
11259303|NCT02625909|FG000|Participant Flow|Drug: Sofosbuvir/Velpatasvir (SOF/VEL) for 6 Weeks|"Open-label sofosbuvir/velpatasvir (SOF/VEL) 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the short treatment duration arm (A) for 6 weeks.~SOF/VEL for 6 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration)."
11259304|NCT02625909|FG001|Participant Flow|Drug: Sofosbuvir/Velpatasvir (SOF/VEL) for 12 Weeks|"Open-label sofosbuvir/velpatasvir (SOF/VEL) 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the standard treatment duration arm (B) for 12 weeks.~SOF/VEL for 12 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration)."
11259305|NCT02625909|OG000|Outcome|Drug: SOF/VEL for 6 Weeks|"Open-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the short treatment duration arm (A) for 6 weeks.~SOF/VEL for 6 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration)."
11259306|NCT02625909|OG001|Outcome|Drug: SOF/VEL for 12 Weeks|"Open-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the standard treatment duration arm (B) for 12 weeks.~SOF/VEL for 12 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration)."
11259307|NCT02625909|EG000|Reported Event|Drug: SOF/VEL for 6 Weeks|"Open-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the short treatment duration arm (A) for 6 weeks.~SOF/VEL for 6 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration)."
11259308|NCT02625909|EG001|Reported Event|Drug: SOF/VEL for 12 Weeks|"Open-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the standard treatment duration arm (B) for 12 weeks.~SOF/VEL for 12 weeks: Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration)."
11259309|NCT02625922|BG000|Baseline|Serelaxin-Placebo|"Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259310|NCT02625922|BG001|Baseline|Placebo-Serelaxin|"Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259311|NCT02625922|BG002|Baseline|Total|Total of all reporting groups
11259312|NCT02625922|FG000|Participant Flow|Serelaxin-Placebo|"Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259313|NCT02625922|FG001|Participant Flow|Placebo-Serelaxin|"Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259314|NCT02625922|OG000|Outcome|Serelaxin-Placebo|"Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259315|NCT02625922|OG001|Outcome|Placebo-Serelaxin|"Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion."
11259316|NCT02625922|OG000|Outcome|Serelaxin|"Participants receiving serelaxin in Treatment Period 1 and in Treatment Period 2.~Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen."
11259317|NCT02625922|OG001|Outcome|Placebo|"Participants receiving placebo in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.~Placebo was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen."
11259318|NCT02625922|EG000|Reported Event|Serelaxin|"Participants receiving serelaxin in Treatment Period 1 and in Treatment Period 2.~Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.~Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen."
11259319|NCT02625922|EG001|Reported Event|Placebo|"Participants receiving placebo in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.~Placebo was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen."
11259320|NCT02625922|EG002|Reported Event|Total|Total
11259321|NCT02625974|BG000|Baseline|Nifurtimox 60 Days / Arm 1|Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
11286614|NCT02890992|EG004|Reported Event|Cohort 3 - Alirocumab 75 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to the switch of dosage added to LMT.
11259322|NCT02625974|BG001|Baseline|Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2|Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
11259323|NCT02625974|BG002|Baseline|Total|Total of all reporting groups
11259324|NCT02625974|FG000|Participant Flow|Nifurtimox 60 Days / Arm 1|Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
11259325|NCT02625974|FG001|Participant Flow|Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2|Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
11259326|NCT02625974|OG000|Outcome|Nifurtimox 60 Days / Arm 1|Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
11259327|NCT02625974|OG001|Outcome|Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2|Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
11259328|NCT02625974|OG000|Outcome|Nifurtimox 60 Days / Arm 1|Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment), 1-year follow-up data
11259329|NCT02625974|OG000|Outcome|Nifurtimox 60 Days Reactive Detectable|Nifurtimox 60 days with Reactive Conventional Serologic Testing and Detectable qPCR
11259330|NCT02625974|OG001|Outcome|Nifurtimox 60 Days Reactive Non-detectable|Nifurtimox 60 days with Reactive Conventional Serologic Testing and Non-detectable qPCR
11259331|NCT02625974|OG002|Outcome|Nifurtimox 60 Days Non-reactive Detectable|Nifurtimox 60 days with Non-reactive Conventional Serologic Testing and Detectable qPCR
11259332|NCT02625974|OG003|Outcome|Nifurtimox 60 Days Non-reactive Non-detectable|Nifurtimox 60 days with Non-reactive Conventional Serologic Testing and Non-detectable qPCR
11259333|NCT02625974|OG004|Outcome|Nifurtimox 60 Days Reactive Non Evaluable|Nifurtimox 60 days with Reactive Conventional Serologic Testing and Non evaluable qPCR
11259334|NCT02625974|OG005|Outcome|Nifurtimox 60 Days Reactive qPCR Missing|Nifurtimox 60 days with Reactive Conventional Serologic Testing and missing qPCR
11259335|NCT02625974|OG006|Outcome|Nifurtimox 30 Days Reactive Detectable|Nifurtimox 30 days with Reactive Conventional Serologic Testing and Detectable qPCR
11259336|NCT02625974|OG007|Outcome|Nifurtimox 30 Days Reactive Non-detectable|Nifurtimox 30 days with Reactive Conventional Serologic Testing and Non-detectable qPCR
11259337|NCT02625974|OG008|Outcome|Nifurtimox 30 Days Non-reactive Detectable|Nifurtimox 30 days with Non-reactive Conventional Serologic Testing and Detectable qPCR
11259338|NCT02625974|OG009|Outcome|Nifurtimox 30 Days Non-reactive Non-detectable|Nifurtimox 30 days with Non-reactive Conventional Serologic Testing and Non-detectable qPCR
11259339|NCT02625974|OG010|Outcome|Nifurtimox 30 Days Reactive Non Evaluable|Nifurtimox 30 days with Reactive Conventional Serologic Testing and Non evaluable qPCR
11259340|NCT02625974|OG011|Outcome|Nifurtimox 30 Days Missing Conventional Testing Non-detectable|Nifurtimox 30 days with missing Conventional Serologic Testing and Non-detectable qPCR
11259341|NCT02625974|OG000|Outcome|Nifurtimox 60 Days Reactive and Reactive|Nifurtimox 60 days with Reactive Conventional Serologic Testing and Reactive Non-conventional Serologic Testing
11259342|NCT02625974|OG001|Outcome|Nifurtimox 60 Days Reactive and Non-reactive|Nifurtimox 60 days with Reactive Conventional Serologic Testing and Non-reactive Non-conventional Serologic Testing
11259343|NCT02625974|OG002|Outcome|Nifurtimox 60 Days Non-reactive and Reactive|Nifurtimox 60 days with Non-reactive Conventional Serologic Testing and Reactive Non-conventional Serologic Testing
11259344|NCT02625974|OG003|Outcome|Nifurtimox 60 Days Non-reactive and Non-reactive|Nifurtimox 60 days with Non-reactive Conventional Serologic Testing and Non-reactive Non-conventional Serologic Testing
11259345|NCT02625974|OG004|Outcome|Nifurtimox 30 Days Reactive and Reactive|Nifurtimox 30 days with Reactive Conventional Serologic Testing and Reactive Non-conventional Serologic Testing
11259346|NCT02625974|OG005|Outcome|Nifurtimox 30 Days Reactive and Non-reactive|Nifurtimox 30 days with Reactive Conventional Serologic Testing and Non-reactive Non-conventional Serologic Testing
11259347|NCT02625974|OG006|Outcome|Nifurtimox 30 Days Non-reactive and Reactive|Nifurtimox 30 days with Non-reactive Conventional Serologic Testing and Reactive Non-conventional Serologic Testing
11259348|NCT02625974|OG007|Outcome|Nifurtimox 30 Days Non-reactive and Non-reactive|Nifurtimox 30 days with Non-reactive Conventional Serologic Testing and Non-reactive Non-conventional Serologic Testing
11259349|NCT02625974|OG000|Outcome|Non-reactive ELISA and Non-reactive IHA|ELISA results: Non-reactive IHA results: Non-reactive
11259350|NCT02625974|OG001|Outcome|Non-reactive ELISA and Reactive IHA Decrease|ELISA results: Non-reactive IHA results: reactive with decreasing in titers
11259351|NCT02625974|OG002|Outcome|Non-react ELISA and React IHA Nochange|ELISA results: Non-reactive IHA results: reactive without change in titers
11259352|NCT02625974|OG003|Outcome|Reactive ELISA: Sero-reduction and Non-react IHA|ELISA results: reactive, Sero-reduction IHA results: Non-reactive
11259353|NCT02625974|OG004|Outcome|Reactive ELISA: Sero Reduction and Reactive IHA Decrease|ELISA results: reactive, Sero-reduction IHA results: reactive with decreasing in titers
11259354|NCT02625974|OG005|Outcome|Reactive ELISA: Sero-reduction and Reactive IHA Nochange|ELISA results: reactive, Sero-reduction IHA results: reactive without Change in titers
11259355|NCT02625974|OG006|Outcome|Reactive ELISA: Others and Non-reactive IHA|ELISA results: reactive, Others IHA results: Non-reactive
11259356|NCT02625974|OG007|Outcome|Reactive ELISA: Others and React IHA Decrease|ELISA results: reactive, Other IHA: reactive with decreasing in titers
11259357|NCT02625974|OG008|Outcome|Reactive ELISA: Others and React IHA Nochange|ELISA results: reactive, Other IHA results: reactive without Change in titers
11259358|NCT02625974|OG009|Outcome|Reactive ELISA: Others and Missing IHA|ELISA results: reactive, Others IHA results: Missing
11259359|NCT02625974|OG000|Outcome|Cure and Non Reactive/Reactive Decreasing|Elisa results: Cure IHA results: Non reactive or reactive but decreasing in titer
11259360|NCT02625974|OG001|Outcome|Cure and Reactive Non-decreasing|Elisa results: Cure IHA results: reactive but non-decreasing in titer
11259361|NCT02625974|OG002|Outcome|No Cure and Non Reactive/Reactive Decreasing|Elisa results: No Cure IHA results: Non reactive or reactive but decreasing in titer
11259362|NCT02625974|OG003|Outcome|No Cure and Reactive Non-decreasing|Elisa results: No Cure IHA results: reactive but non-decreasing in titer
11259363|NCT02625974|OG004|Outcome|No Cure and Missing IHA Testing|Elisa results: No Cure IHA results: Missing
11259364|NCT02625974|EG000|Reported Event|Nifurtimox 60 Days / Arm 1|Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
11259365|NCT02625974|EG001|Reported Event|Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2|Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
11259366|NCT02626000|BG000|Baseline|Talimogene Laherparepvec + Pembrolizumab|"Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.~Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first."
11259367|NCT02626000|FG000|Participant Flow|Talimogene Laherparepvec + Pembrolizumab|"Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.~Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first."
11259368|NCT02626000|OG000|Outcome|Talimogene Laherparepvec + Pembrolizumab|"Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.~Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first."
11259369|NCT02626000|OG000|Outcome|Talimogene Laherparepvec + Pembrolizumab|"Talimogene laherparepvec (T-VEC) was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.~Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first."
11259370|NCT02626000|EG000|Reported Event|Talimogene Laherparepvec + Pembrolizumab|"Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.~Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first."
11259371|NCT02626026|BG000|Baseline|Cohort 1, Part A: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week.
11259372|NCT02626026|BG001|Baseline|Cohort 1, Part A: Placebo|Placebo to match tirabrutinib capsules orally QD in the morning for 1 week.
11259373|NCT02626026|BG002|Baseline|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259374|NCT02626026|BG003|Baseline|Cohort 2, Part A: Placebo|Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259375|NCT02626026|BG004|Baseline|Part B: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally QD for 4 weeks.
11259376|NCT02626026|BG005|Baseline|Part B: Placebo|Placebo to match tirabrutinib capsules orally QD for 4 weeks.
11259377|NCT02626026|BG006|Baseline|Total|Total of all reporting groups
11259378|NCT02626026|FG000|Participant Flow|Cohort 1, Part A: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week.
11259379|NCT02626026|FG001|Participant Flow|Cohort 1, Part A: Placebo|Placebo to match tirabrutinib capsules orally QD in the morning for 1 week.
11259380|NCT02626026|FG002|Participant Flow|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259381|NCT02626026|FG003|Participant Flow|Cohort 2, Part A: Placebo|Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259382|NCT02626026|FG004|Participant Flow|Part B: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally QD for 4 weeks.
11259383|NCT02626026|FG005|Participant Flow|Part B: Placebo|Placebo to match tirabrutinib capsules orally QD for 4 weeks.
11259384|NCT02626026|OG000|Outcome|Cohort 1, Part A: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week.
11259385|NCT02626026|OG001|Outcome|Cohort 1, Part A: Placebo|Placebo to match tirabrutinib capsules orally QD in the morning for 1 week.
11259386|NCT02626026|OG002|Outcome|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259387|NCT02626026|OG003|Outcome|Cohort 2, Part A: Placebo|Placebo to match tirabrutinib 10 mg capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259388|NCT02626026|OG000|Outcome|Cohort 1, Part A: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally QD in the morning for 1 week.
11259389|NCT02626026|OG002|Outcome|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259390|NCT02626026|OG003|Outcome|Cohort 2, Part A: Placebo|Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259391|NCT02626026|OG001|Outcome|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259392|NCT02626026|OG000|Outcome|Part B: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally QD for 4 weeks.
11259393|NCT02626026|OG001|Outcome|Part B: Placebo|Placebo to match tirabrutinib capsules orally QD for 4 weeks.
11259394|NCT02626026|EG000|Reported Event|Cohort 1, Part A: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week.
11259395|NCT02626026|EG001|Reported Event|Cohort 2, Part A: Tirabrutinib 10 mg BID|Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.
11259396|NCT02626026|EG002|Reported Event|Part B: Tirabrutinib 20 mg QD|Tirabrutinib 20 mg capsules orally QD for 4 weeks.
11259397|NCT02626026|EG003|Reported Event|All Placebo|Cohort 1, Part A: Placebo to match tirabrutinib capsules orally QD in the morning for 1 week; Cohort 2, Part A: Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered. Part B, Placebo to match tirabrutinib capsules orally QD for 4 weeks.
11259398|NCT02626156|BG000|Baseline|Cooling Gel Pack - Venous Leg Ulcer|"A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259399|NCT02626156|BG001|Baseline|Cooling Cotton Pack - Venous Leg Ulcer|"A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259400|NCT02626156|BG002|Baseline|Cooling Gel Pack - Diabetic Foot Ulcer|"A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259401|NCT02626156|BG003|Baseline|Cooling Cotton Pack - Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259402|NCT02626156|BG004|Baseline|Total|Total of all reporting groups
11259403|NCT02626156|FG000|Participant Flow|Cooling Gel Pack Diabetic Foot Ulcer|"A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11286615|NCT02890992|EG005|Reported Event|Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the switch of dosage added to LMT.
11286616|NCT02890992|EG006|Reported Event|Cohort 4 - Alirocumab 150 mg Q4W: <50 kg|Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
11286617|NCT02890992|EG007|Reported Event|Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg|Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
11259404|NCT02626156|FG001|Participant Flow|Cooling Cotton Pack Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259405|NCT02626156|FG002|Participant Flow|Cooling Gel Pack Venous Leg Ulcer|"A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259406|NCT02626156|FG003|Participant Flow|Cooling Cotton Pack Venous Leg Ulcer|"A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259407|NCT02626156|OG000|Outcome|Cooling Gel Pack - Venous Leg Ulcer|"A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259408|NCT02626156|OG001|Outcome|Cooling Cotton Pack - Venous Leg Ulcer|"A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259409|NCT02626156|OG002|Outcome|Cooling Gel Pack - Diabetic Foot Ulcer|"A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259410|NCT02626156|OG003|Outcome|Cotton Cooling Pack - Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259411|NCT02626156|OG003|Outcome|Cooling Cotton Pack - Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259412|NCT02626156|OG000|Outcome|Cooling Gel Pack|A cooling pack was applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients self monitored skin temperature of affected skin daily 3 times per week to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.
11259413|NCT02626156|OG001|Outcome|Cooling Cotton Pack|A cooling cotton pack was applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients self monitored skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.
11259414|NCT02626156|OG000|Outcome|Adherence|All participants were assessed for adherence to the temperature and cooling protocols.
11259415|NCT02626156|OG001|Outcome|Cooling Cotton Pack - Venus Leg Ulcer|"A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259416|NCT02626156|OG003|Outcome|Cotton Gel Pack - Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259417|NCT02626156|EG000|Reported Event|Cooling Gel Pack - Venous Leg Ulcer|"A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259418|NCT02626156|EG001|Reported Event|Cooling Cotton Pack - Venous Leg Ulcer|"A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259419|NCT02626156|EG002|Reported Event|Cooling Gel Pack - Diabetic Foot Ulcer|"A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259420|NCT02626156|EG003|Reported Event|Cooling Cotton Pack - Diabetic Foot Ulcer|"A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.~Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature."
11259421|NCT02626182|BG000|Baseline|Sildenafil|"Subjects will be randomized in a 3:1 (sildenafil:placebo) fashion. Subjects randomized to the treatment arm will receive sildenafil 20 mg p.o. t.i.d for 1 week followed by 40 mg p.o. t.i.d. for 11 weeks.~sildenafil: active sildenafil"
11259422|NCT02626182|BG001|Baseline|Placebo|"Subjects randomized to the placebo arm will receive placebo p.o. t.i.d for 1 week followed by 2 placebo tablets p.o. t.i.d. for 11 weeks.~placebo: sugar pill that looks like sildenafil tablets"
11259423|NCT02626182|BG002|Baseline|Total|Total of all reporting groups
11259424|NCT02626182|FG000|Participant Flow|Sildenafil|"Subjects will be randomized in a 3:1 (sildenafil:placebo) fashion. Subjects randomized to the treatment arm will receive sildenafil 20 mg p.o. t.i.d for 1 week followed by 40 mg p.o. t.i.d. for 11 weeks.~sildenafil: active sildenafil"
11259425|NCT02626182|FG001|Participant Flow|Placebo|"Subjects randomized to the placebo arm will receive placebo p.o. t.i.d for 1 week followed by 2 placebo tablets p.o. t.i.d. for 11 weeks.~placebo: sugar pill that looks like sildenafil tablets"
11259426|NCT02626182|OG000|Outcome|Sildenafil|Subjects who received sildenafil 40 mg po tid
11259427|NCT02626182|OG001|Outcome|Placebo|Subjects who received placebo for 12 weeks
11259428|NCT02626182|EG000|Reported Event|Sildenafil|"Subjects will be randomized in a 3:1 (sildenafil:placebo) fashion. Subjects randomized to the treatment arm will receive sildenafil 20 mg p.o. t.i.d for 1 week followed by 40 mg p.o. t.i.d. for 11 weeks.~sildenafil: active sildenafil"
11259429|NCT02626182|EG001|Reported Event|Placebo|"Subjects randomized to the placebo arm will receive placebo p.o. t.i.d for 1 week followed by 2 placebo tablets p.o. t.i.d. for 11 weeks.~placebo: sugar pill that looks like sildenafil tablets"
11259430|NCT02626611|BG000|Baseline|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259431|NCT02626611|BG001|Baseline|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259432|NCT02626611|BG002|Baseline|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259433|NCT02626611|BG003|Baseline|Total|Total of all reporting groups
11259434|NCT02626611|FG000|Participant Flow|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259435|NCT02626611|FG001|Participant Flow|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259436|NCT02626611|FG002|Participant Flow|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11286618|NCT02890992|EG008|Reported Event|Alirocumab 40 Q2W Post-switch|Participants with body weight < 50 kg from cohort 1, 2 and 3 switched to dosage and received SC injection of alirocumab 40 mg administered Q2W from the switch up to the end of the OLE period (up to 130 weeks) added to LMT.
11286619|NCT02890992|EG009|Reported Event|Alirocumab 75 Q2W Post-switch|Participants from Cohort 1 (7 participants), Cohort 2 and Cohort 3 (11 participants) switched to dosage and received SC injection of alirocumab 75 mg administered Q2W up to the end of the OLE period (up to 130 weeks) added to LMT.
11259437|NCT02626611|OG000|Outcome|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259438|NCT02626611|OG001|Outcome|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259439|NCT02626611|OG002|Outcome|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259440|NCT02626611|OG000|Outcome|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
11259441|NCT02626611|OG001|Outcome|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
11259442|NCT02626611|OG002|Outcome|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks.~Omalizumab: Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 m"
11259443|NCT02626611|OG000|Outcome|Placebo|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
10820334|NCT00056862|OG000|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
11259444|NCT02626611|OG001|Outcome|Low Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
11259445|NCT02626611|OG002|Outcome|High Dose Food|Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food.
11259446|NCT02626611|EG000|Reported Event|All Participants Prior to Active Phase|Only Xolair administered before active phase began.
11286620|NCT02891070|BG000|Baseline|Tisseel|Tisseel (FS VH S/D 500 s-apr), single use treatment, was administered intra-operatively with sutures during dural closure. Product was applied with cannula by dripping in a thin and continuous layer with a 5 mm overlap on each side of the sutured line, ensuring that all suture holes were covered.
11286621|NCT02891070|BG001|Baseline|DuraSeal|DuraSeal Dural Sealant, single use treatment, was administered intra-operatively with sutures during dural closure. The product was applied with the DuraSeal System Applicator by spraying a thin (1 - 2 mm) coating, ensuring that all suture holes were covered.
11286622|NCT02891070|BG002|Baseline|Total|Total of all reporting groups
11259447|NCT02626611|EG001|Reported Event|Placebo|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259448|NCT02626611|EG002|Reported Event|Low Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 -16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259449|NCT02626611|EG003|Reported Event|High Dose Food|"Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.~Omalizumab: Omalizumab is administered per product insert from weeks 0 - 16 of the study.~Food Flour Buildup: Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized."
11259450|NCT02626780|BG000|Baseline|SVF Injection|"Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.~GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF."
11259451|NCT02626780|FG000|Participant Flow|SVF Injection|"Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.~GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF."
11259452|NCT02626780|OG000|Outcome|SVF Injection|"Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.~GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF."
11259453|NCT02626780|EG000|Reported Event|SVF Injection|"Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.~GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF."
11259454|NCT02626819|BG000|Baseline|Arm 1: Receiving MOVE! Toward Your Goals|"Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)~MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members"
11259455|NCT02626819|BG001|Baseline|Arm 2: Receiving Enhanced Usual Care|"Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)~Enhanced Usual Care: Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
11259456|NCT02626819|BG002|Baseline|Total|Total of all reporting groups
11259457|NCT02626819|FG000|Participant Flow|Arm 1: Receiving MOVE! Toward Your Goals|"Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)~MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members"
11259458|NCT02626819|FG001|Participant Flow|Arm 2: Receiving Enhanced Usual Care|"Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)~Enhanced Usual Care: Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
11259459|NCT02626819|OG000|Outcome|Arm 1: Receiving MOVE! Toward Your Goals|"Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)~MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members"
11286623|NCT02891070|FG000|Participant Flow|Tisseel|Tisseel (FS VH S/D 500 s-apr), single use treatment, was administered intra-operatively with sutures during dural closure. Product was applied with cannula by dripping in a thin and continuous layer with a 5 mm overlap on each side of the sutured line, ensuring that all suture holes were covered.
11259460|NCT02626819|OG001|Outcome|Arm 2: Receiving Enhanced Usual Care|"Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)~Enhanced Usual Care: Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
11259461|NCT02626819|EG000|Reported Event|Arm 1: Receiving MOVE! Toward Your Goals|"Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)~MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members"
11259462|NCT02626819|EG001|Reported Event|Arm 2: Receiving Enhanced Usual Care|"Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)~Enhanced Usual Care: Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
11259463|NCT02626910|BG000|Baseline|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
11259464|NCT02626910|BG001|Baseline|Second Life: People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
11259465|NCT02626910|BG002|Baseline|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
11259466|NCT02626910|BG003|Baseline|Urban Group|People with and without disabilities recruited from an Urban setting.
11259467|NCT02626910|BG004|Baseline|Total|Total of all reporting groups
11259468|NCT02626910|FG000|Participant Flow|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
11259469|NCT02626910|FG001|Participant Flow|Second Life: People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
11259470|NCT02626910|FG002|Participant Flow|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
11259471|NCT02626910|FG003|Participant Flow|Urban Group|People with and without disabilities recruited from an Urban setting.
11259472|NCT02626910|OG000|Outcome|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
11259473|NCT02626910|OG001|Outcome|Second Life: People Without Disabilities|People without disabilities recruited fro the virtual world Second Life
11259474|NCT02626910|OG002|Outcome|Second Life: Clinicians|Clinicians recruited from the virtual world Second life
11259475|NCT02626910|OG003|Outcome|Urban|People with and without disabilities recruited from an Urban community
11259476|NCT02626910|EG000|Reported Event|Second Life: People With Disabilities|People with disabilities recruited from the virtual world, Second life.
11259477|NCT02626910|EG001|Reported Event|Second Life:People Without Disabilities|People without disabilities recruited from the virtual world, Second life.
11259478|NCT02626910|EG002|Reported Event|Second Life: Clinicians|Clinicians recruited from the virtual world, Second life.
11259479|NCT02626910|EG003|Reported Event|Urban|People with and without disabilities recruited from an Urban community.
11259480|NCT02627001|BG000|Baseline|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
11259481|NCT02627001|BG001|Baseline|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device.~Bag Valve Mask: Conventional bag valve mask"
11259482|NCT02627001|BG002|Baseline|Total|Total of all reporting groups
11259483|NCT02627001|FG000|Participant Flow|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
11259484|NCT02627001|FG001|Participant Flow|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask.~Bag Valve Mask: Conventional bag valve mask"
11259485|NCT02627001|OG000|Outcome|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
11259486|NCT02627001|OG001|Outcome|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
11259487|NCT02627001|EG000|Reported Event|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
11259488|NCT02627001|EG001|Reported Event|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
11259489|NCT02627118|BG000|Baseline|Dialyzer Comparison|2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
11259490|NCT02627118|FG000|Participant Flow|Dialyzer Comparison|2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
11259491|NCT02627118|OG000|Outcome|Dialyzer Comparison|2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
11259492|NCT02627118|EG000|Reported Event|FRESENIUS OPTIFLUX 160NR|2 MONTHS OF DIALYSIS WITH THE FRESENIUS OPTIFLUX 160NR
11259493|NCT02627118|EG001|Reported Event|NIPRO ELISIO-15H|2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
11259494|NCT02627144|BG000|Baseline|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
11259495|NCT02627144|FG000|Participant Flow|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
11259496|NCT02627144|OG000|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
11259497|NCT02627144|EG000|Reported Event|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
10969952|NCT00908037|EG000|Reported Event|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
11259498|NCT02627495|BG000|Baseline|tDCS Intervention (Open Label)|"Subjects will undergo tDCS stimulation~transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period."
11259499|NCT02627495|FG000|Participant Flow|tDCS Intervention (Open Label)|"Subjects will undergo tDCS stimulation~transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period."
11259500|NCT02627495|OG000|Outcome|tDCS Intervention (Open Label)|"Subjects will undergo tDCS stimulation~transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period."
11259501|NCT02627495|EG000|Reported Event|tDCS Intervention (Open Label)|"Subjects will undergo tDCS stimulation~transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period."
11259502|NCT02627677|BG000|Baseline|Cohort A: Ponatinib 30 mg|Ponatinib 30 mg, tablets, orally, once daily (QD) until achievement of major molecular response (MMR) up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 42 months.
11259503|NCT02627677|BG001|Baseline|Cohort B: Ponatinib 15 mg|Ponatinib 15 mg, tablets, orally, QD until achievement of MMR up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 45 months.
11259504|NCT02627677|BG002|Baseline|Cohort C: Nilotinib 400 mg|Nilotinib 400 mg, tablets, orally, twice daily up to approximately 42 months.
11259505|NCT02627677|BG003|Baseline|Total|Total of all reporting groups
11259506|NCT02627677|FG000|Participant Flow|Cohort A: Ponatinib 30 mg|Ponatinib 30 mg, tablets, orally, once daily (QD) until achievement of major molecular response (MMR) up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 42 months.
11259507|NCT02627677|FG001|Participant Flow|Cohort B: Ponatinib 15 mg|Ponatinib 15 mg, tablets, orally, QD until achievement of MMR up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 45 months.
11259508|NCT02627677|FG002|Participant Flow|Cohort C: Nilotinib 400 mg|Nilotinib 400 mg, tablets, orally, twice daily up to approximately 42 months.
11259509|NCT02627677|OG000|Outcome|Cohort A: Ponatinib 30 mg|Ponatinib 30 mg, tablets, orally, once daily (QD) until achievement of major molecular response (MMR) up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 42 months.
11259510|NCT02627677|OG001|Outcome|Cohort B: Ponatinib 15 mg|Ponatinib 15 mg, tablets, orally, QD until achievement of MMR up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 45 months.
11259511|NCT02627677|OG002|Outcome|Cohort C: Nilotinib 400 mg|Nilotinib 400 mg, tablets, orally, twice daily up to approximately 42 months.
11259512|NCT02627677|OG001|Outcome|Cohort B: Ponatinib 15 mg|Ponatinib 15 mg, tablets, orally, QD until achievement of MMR up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 45months.
11259513|NCT02627677|EG000|Reported Event|Cohort A: Ponatinib 30 mg|Ponatinib 30 mg, tablets, orally, once daily (QD) until achievement of major molecular response (MMR) up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 42 months.
11259514|NCT02627677|EG001|Reported Event|Cohort B: Ponatinib 15 mg|Ponatinib 15 mg, tablets, orally, QD until achievement of MMR up to 12 months. Once MMR was achieved, participants received reduced dose of ponatinib 15 mg orally once daily up to approximately 45 months.
11259515|NCT02627677|EG002|Reported Event|Cohort C: Nilotinib 400 mg|Nilotinib 400 mg, tablets, orally, twice daily up to approximately 42 months.
11259516|NCT02627794|BG000|Baseline|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259517|NCT02627794|FG000|Participant Flow|Restora™ Steroid Eluting & Silastic Silicone Spacers|"This study arm receives both the experimental treatment, a Restora™ Steroid eluting spacer and Silastic Silicone spacer.~Both spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259518|NCT02627794|OG000|Outcome|Silastic Silicone Spacer|"Silastic Silicone spacers are actively being used as the standard of care.~Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259519|NCT02627794|OG001|Outcome|Restora™ Steroid Eluting Spacer|"This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.~Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259520|NCT02627794|OG000|Outcome|Restora™ Steroid Eluting & Silastic Silicone Spacer|"This arm receives both Restora™ Steroid eluting & Silastic Silicone spacers.~The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259521|NCT02627794|EG000|Reported Event|Silastic Silicone Spacer|"Silastic Silicone spacers are actively being used as the standard of care.~Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259522|NCT02627794|EG001|Reported Event|Restora™ Steroid Eluting Spacer|"This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.~Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery."
11259523|NCT02627924|BG000|Baseline|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
10969953|NCT00908037|EG001|Reported Event|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
11259524|NCT02627924|FG000|Participant Flow|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11259525|NCT02627924|OG000|Outcome|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11259526|NCT02627924|OG000|Outcome|Baseline|Participants who completed the patient treatment satisfaction questionnaire at baseline.
11259527|NCT02627924|OG001|Outcome|Week 12|Participants who completed the patient treatment satisfaction questionnaire at week 12
11259528|NCT02627924|OG002|Outcome|Week 24|Participants who completed the patient treatment satisfaction questionnaire at week 24.
11259529|NCT02627924|EG000|Reported Event|Adalimumab|Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
11259530|NCT02628028|BG000|Baseline|Part A: Placebo|Participants received oral dose of placebo once daily (QD) for 4 weeks.
11259531|NCT02628028|BG001|Baseline|Part A: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
11259532|NCT02628028|BG002|Baseline|Part A: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
11259533|NCT02628028|BG003|Baseline|Part A: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
11259534|NCT02628028|BG004|Baseline|Part B: Placebo|Participants received oral dose of placebo QD for 12 weeks.
11259535|NCT02628028|BG005|Baseline|Part B: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
11259536|NCT02628028|BG006|Baseline|Part B: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
11259537|NCT02628028|BG007|Baseline|Part B: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
11259538|NCT02628028|BG008|Baseline|Total|Total of all reporting groups
11259539|NCT02628028|FG000|Participant Flow|Part A: Placebo|Participants received oral dose of placebo once daily (QD) for 4 weeks.
11259540|NCT02628028|FG001|Participant Flow|Part A: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
11259541|NCT02628028|FG002|Participant Flow|Part A: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
11259542|NCT02628028|FG003|Participant Flow|Part A: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
11259543|NCT02628028|FG004|Participant Flow|Part B: Placebo|Participants received oral dose of placebo QD for 12 weeks.
11259544|NCT02628028|FG005|Participant Flow|Part B: 5 mg LY3337641|"Part B Dosing period: Participants received oral dose of 5 mg LY3337641 tablet QD for 12 weeks.~Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks."
11259545|NCT02628028|FG006|Participant Flow|Part B: 10 mg LY3337641|"Participants received oral dose of 10 mg LY3337641 tablet QD for 12 weeks.~Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks."
11259546|NCT02628028|FG007|Participant Flow|Part B: 30 mg LY3337641|"Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.~Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks."
11259547|NCT02628028|OG000|Outcome|Part A: Placebo|Participants received oral dose of placebo once daily (QD) for 4 weeks.
11259548|NCT02628028|OG001|Outcome|Part A: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
11259549|NCT02628028|OG002|Outcome|Part A: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
11259550|NCT02628028|OG003|Outcome|Part A: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
11259551|NCT02628028|OG000|Outcome|Part B: Placebo|Participants received oral dose of placebo QD for 12 weeks.
11259552|NCT02628028|OG001|Outcome|Part B: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
11259553|NCT02628028|OG002|Outcome|Part B: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
11259554|NCT02628028|OG003|Outcome|Part B: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
11259555|NCT02628028|OG000|Outcome|LY3337641|Participants received oral doses of 5 mg, 10 mg and 30 mg LY3337641 QD for 4 weeks in Part A and 12 weeks in Part B.
11259556|NCT02628028|EG000|Reported Event|Part A: Placebo|Participants received oral dose of placebo once daily (QD) for 4 weeks.
11259557|NCT02628028|EG001|Reported Event|Part A: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
11259558|NCT02628028|EG002|Reported Event|Part A: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
11259559|NCT02628028|EG003|Reported Event|Part A: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
11259560|NCT02628028|EG004|Reported Event|Part B: Placebo|Participants received oral dose of placebo QD for 12 weeks.
11259561|NCT02628028|EG005|Reported Event|Part B: 5 mg LY3337641|Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
11259562|NCT02628028|EG006|Reported Event|Part B: 10 mg LY3337641|Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
11259563|NCT02628028|EG007|Reported Event|Part B: 30 mg LY3337641|Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
11259564|NCT02628028|EG008|Reported Event|Long-Term Extension: 5 mg LY3337641|Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.
11259565|NCT02628028|EG009|Reported Event|Long-Term Extension: 10 mg LY3337641|Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.
11259566|NCT02628028|EG010|Reported Event|Long-Term Extension: 30 mg LY3337641|Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.
11259567|NCT02628093|BG000|Baseline|THUNDERBEAT|"THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels~THUNDERBEAT: Tissue dissection and vessels ligation"
11259568|NCT02628093|BG001|Baseline|LIGASURE|"LIGASURE energy device will be used for dissection of tissue and ligation of vessels~LIGASURE: Tissue dissection and vessels ligation"
11259569|NCT02628093|BG002|Baseline|Total|Total of all reporting groups
11259570|NCT02628093|FG000|Participant Flow|THUNDERBEAT|"THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels~THUNDERBEAT: Tissue dissection and vessels ligation"
11259571|NCT02628093|FG001|Participant Flow|LIGASURE|"LIGASURE energy device will be used for dissection of tissue and ligation of vessels~LIGASURE: Tissue dissection and vessels ligation"
11259572|NCT02628093|OG000|Outcome|THUNDERBEAT|"THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels~THUNDERBEAT: Tissue dissection and vessels ligation"
11259573|NCT02628093|OG001|Outcome|LIGASURE|"LIGASURE energy device will be used for dissection of tissue and ligation of vessels~LIGASURE: Tissue dissection and vessels ligation"
11259574|NCT02628093|EG000|Reported Event|THUNDERBEAT|"THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels~THUNDERBEAT: Tissue dissection and vessels ligation"
11259575|NCT02628093|EG001|Reported Event|LIGASURE|"LIGASURE energy device will be used for dissection of tissue and ligation of vessels~LIGASURE: Tissue dissection and vessels ligation"
11259576|NCT02628106|BG000|Baseline|Lipo-prostaglandin E1|"all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.~Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days"
11259577|NCT02628106|FG000|Participant Flow|Diabetic Nephropathy,Chronic Kidney Disease|all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
11259578|NCT02628106|OG000|Outcome|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
11259579|NCT02628106|EG000|Reported Event|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
11259580|NCT02628223|BG000|Baseline|180 Degrees|"180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259581|NCT02628223|BG001|Baseline|360 Degrees|"360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259582|NCT02628223|BG002|Baseline|Total|Total of all reporting groups
11259583|NCT02628223|FG000|Participant Flow|180 Degrees|"180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259584|NCT02628223|FG001|Participant Flow|360 Degrees|"360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259585|NCT02628223|OG000|Outcome|180 Degrees|"180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259586|NCT02628223|OG001|Outcome|360 Degrees|"360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259587|NCT02628223|EG000|Reported Event|180 Degrees|"180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259588|NCT02628223|EG001|Reported Event|360 Degrees|"360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser~Selective Laser Trabeculoplasty: The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.~Neodymium:Yttrium Aluminum Garnet (YAG) laser: The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp."
11259589|NCT02628236|BG000|Baseline|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11259590|NCT02628236|FG000|Participant Flow|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11259591|NCT02628236|OG000|Outcome|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
10820335|NCT00056862|OG001|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
11259592|NCT02628236|EG000|Reported Event|ALA-PDT|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
11259593|NCT02628418|BG000|Baseline|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11259594|NCT02628418|BG001|Baseline|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific Hand Rehabilitation (SHR) performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259595|NCT02628418|BG002|Baseline|Total|Total of all reporting groups
11259596|NCT02628418|FG000|Participant Flow|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11259597|NCT02628418|FG001|Participant Flow|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259598|NCT02628418|OG000|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11259599|NCT02628418|OG001|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259600|NCT02628418|OG000|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11286624|NCT02891070|FG001|Participant Flow|DuraSeal|DuraSeal Dural Sealant, single use treatment, was administered intra-operatively with sutures during dural closure. The product was applied with the DuraSeal System Applicator by spraying a thin (1 - 2 mm) coating, ensuring that all suture holes were covered.
11259601|NCT02628418|OG001|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259602|NCT02628418|OG001|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR on performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259603|NCT02628418|OG001|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259604|NCT02628418|OG000|Outcome|Gloreha Group|"TThe patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11259605|NCT02628418|OG001|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259606|NCT02628418|EG000|Reported Event|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
11259607|NCT02628418|EG001|Reported Event|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
11259608|NCT02628600|BG000|Baseline|Prior LAI + Multidrug Regimen|Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.
11259609|NCT02628600|BG001|Baseline|Prior Multidrug Regimen Alone|Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.
11259610|NCT02628600|BG002|Baseline|Total|Total of all reporting groups
11259611|NCT02628600|FG000|Participant Flow|Prior LAI + Multidrug Regimen|Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.
11259612|NCT02628600|FG001|Participant Flow|Prior Multidrug Regimen Alone|Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.
11259613|NCT02628600|OG000|Outcome|Prior LAI + Multidrug Regimen|Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.
11259614|NCT02628600|OG001|Outcome|Prior Multidrug Regimen Alone|Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.
11259615|NCT02628600|EG000|Reported Event|Prior LAI + Multidrug Regimen|Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.
11259616|NCT02628600|EG001|Reported Event|Prior Multidrug Regimen Alone|Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.
11259617|NCT02628743|BG000|Baseline|Olesoxime|Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.
11259618|NCT02628743|FG000|Participant Flow|Olesoxime|Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.
11259619|NCT02628743|OG000|Outcome|Olesoxime|Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.
11259620|NCT02628743|EG000|Reported Event|Olesoxime|Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.
11259621|NCT02628769|BG000|Baseline|All Participant|All participants cross-over study
11259622|NCT02628769|FG000|Participant Flow|First Solithromycin, Then Placebo|First 28-day treatment of 400 mg Solithromycin taken once a day, then 28-day treatment with placebo taken once per day.
11259623|NCT02628769|FG001|Participant Flow|First Placebo, Then Solithromycin|First 28-day treatment with placebo taken once per day, then 28-day treatment of 400 mg Solithromycin taken once a day.
11259624|NCT02628769|OG000|Outcome|Solithromycin|28 day treatment of 400 mg Solithromycin taken once a day.
11259625|NCT02628769|OG001|Outcome|Placebo|28 day treatment with placebo taken once per day.
11259626|NCT02628769|EG000|Reported Event|Solithromycin|28 day treatment of 400 mg Solithromycin taken once a day.
11259627|NCT02628769|EG001|Reported Event|Placebo|28 day treatment with placebo taken once per day.
11259628|NCT02628873|BG000|Baseline|Arm 1 (HyCoSy Followed by HSG)|"HyCoSy procedure followed by HSG procedure~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes"
11259629|NCT02628873|BG001|Baseline|Arm 2 (HSG Followed by HyCoSy)|"HSG procedure followed by HyCoSy procedure~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes"
11259630|NCT02628873|BG002|Baseline|Total|Total of all reporting groups
11259631|NCT02628873|FG000|Participant Flow|Arm 1 (HyCoSy Followed by HSG)|"HyCoSy followed by HSG~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes"
11259632|NCT02628873|FG001|Participant Flow|Arm 2 (HSG Followed by HyCoSy)|"HSG followed by HyCoSy~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes"
11259633|NCT02628873|OG000|Outcome|Arm 1 (HyCoSy Followed by HSG)|HyCoSy procedure followed by HSG procedure
11259634|NCT02628873|OG001|Outcome|Arm 2 (HSG Followed by HyCoSy)|HSG procedure followed by HyCoSy procedure
11259635|NCT02628873|EG000|Reported Event|HyCoSy Followed by HSG|"HyCoSy followed by HSG~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes~followed by:~HSG performed to evaluate the patency (openness) of the fallopian tubes"
11259636|NCT02628873|EG001|Reported Event|Hysterosalpingogram (HSG) Followed by HyCoSy|"Hysterosalpingogram (HSG) followed by HyCoSy~HSG performed to evaluate the patency (openness) of the fallopian tubes~followed by:~HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes"
11259637|NCT02628938|BG000|Baseline|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
11259638|NCT02628938|BG001|Baseline|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
11259639|NCT02628938|BG002|Baseline|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
11259640|NCT02628938|BG003|Baseline|Total|Total of all reporting groups
11259641|NCT02628938|FG000|Participant Flow|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
11259642|NCT02628938|FG001|Participant Flow|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
11259643|NCT02628938|FG002|Participant Flow|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
11259644|NCT02628938|OG000|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
11259645|NCT02628938|OG001|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
11259646|NCT02628938|OG002|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
11259647|NCT02628938|EG000|Reported Event|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
11259648|NCT02628938|EG001|Reported Event|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
11259649|NCT02628938|EG002|Reported Event|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
11259650|NCT02628964|BG000|Baseline|4.5% E-cig|"e-cigarettes with nicotine cartridges~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259651|NCT02628964|BG001|Baseline|0 mg E-cig|"e-cigarettes with placebo cartridges (0mg).~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259652|NCT02628964|BG002|Baseline|Total|Total of all reporting groups
11259653|NCT02628964|FG000|Participant Flow|4.5% E-cig|"e-cigarettes with nicotine cartridges~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259654|NCT02628964|FG001|Participant Flow|0 mg E-cig|"e-cigarettes with placebo cartridges (0mg).~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259655|NCT02628964|OG000|Outcome|4.5% E-cig|"e-cigarettes with nicotine cartridges~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259656|NCT02628964|OG001|Outcome|0 mg E-cig|"e-cigarettes with placebo cartridges (0mg).~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259657|NCT02628964|EG000|Reported Event|4.5% E-cig|"e-cigarettes with nicotine cartridges~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259658|NCT02628964|EG001|Reported Event|0 mg E-cig|"e-cigarettes with placebo cartridges (0mg).~e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges."
11259659|NCT02629094|BG000|Baseline|Eplerenone|Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
11259660|NCT02629094|FG000|Participant Flow|Eplerenone|Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
11259661|NCT02629094|OG000|Outcome|Eplerenone|Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
11259662|NCT02629094|EG000|Reported Event|Eplerenone|Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
11259663|NCT02629133|BG000|Baseline|SHE Program|"Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute booster session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.~SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use."
11259664|NCT02629133|BG001|Baseline|Control Condition|Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
11259665|NCT02629133|BG002|Baseline|Total|Total of all reporting groups
11259666|NCT02629133|FG000|Participant Flow|SHE Program|"Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute booster session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.~SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use."
11259667|NCT02629133|FG001|Participant Flow|Control Condition|Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
11286625|NCT02891070|OG000|Outcome|Tisseel|Tisseel (FS VH S/D 500 s-apr), single use treatment, was administered intra-operatively with sutures during dural closure. Product was applied with cannula by dripping in a thin and continuous layer with a 5 mm overlap on each side of the sutured line, ensuring that all suture holes were covered.
11286626|NCT02891070|OG001|Outcome|DuraSeal|DuraSeal Dural Sealant, single use treatment, was administered intra-operatively with sutures during dural closure. The product was applied with the DuraSeal System Applicator by spraying a thin (1 - 2 mm) coating, ensuring that all suture holes were covered.
11259668|NCT02629133|OG000|Outcome|SHE Program|"Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute booster session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.~SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use."
11259669|NCT02629133|OG001|Outcome|Control Condition|Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
11259670|NCT02629133|EG000|Reported Event|SHE Program|"Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute booster session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.~SHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use."
11259671|NCT02629133|EG001|Reported Event|Control Condition|Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.
11259672|NCT02629354|BG000|Baseline|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
11259673|NCT02629354|BG001|Baseline|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
11259674|NCT02629354|BG002|Baseline|Total|Total of all reporting groups
11259675|NCT02629354|FG000|Participant Flow|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
11259676|NCT02629354|FG001|Participant Flow|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
11259677|NCT02629354|OG000|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
11259678|NCT02629354|OG001|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
11259679|NCT02629354|EG000|Reported Event|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
11259680|NCT02629354|EG001|Reported Event|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
11259681|NCT02629822|BG000|Baseline|DOR/3TC/TDF|Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
11259682|NCT02629822|FG000|Participant Flow|DOR/3TC/TDF|Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
11259683|NCT02629822|OG000|Outcome|DOR/3TC/TDF|Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
11259684|NCT02629822|EG000|Reported Event|DOR/3TC/TDF Base Study: Day 1 to Week 96|Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study.
11259685|NCT02629822|EG001|Reported Event|DOR/3TC/TDF Study Extension: Week 97 to Week 192|Eligible participants who chose to continue on study received the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.
11259686|NCT02629861|BG000|Baseline|Placebo|Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.
11259687|NCT02629861|BG001|Baseline|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11259688|NCT02629861|BG002|Baseline|Fremanezumab 225/225/225 mg|Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.
11259689|NCT02629861|BG003|Baseline|Total|Total of all reporting groups
11259690|NCT02629861|FG000|Participant Flow|Placebo|Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.
11259691|NCT02629861|FG001|Participant Flow|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11259692|NCT02629861|FG002|Participant Flow|Fremanezumab 225/225/225 mg|Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.
11259693|NCT02629861|OG000|Outcome|Placebo|Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.
11259694|NCT02629861|OG001|Outcome|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11259695|NCT02629861|OG002|Outcome|Fremanezumab 225/225/225 mg|Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.
11259696|NCT02629861|EG000|Reported Event|Placebo|Participants randomized to receive placebo received three 1.5-mL placebo injections Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.
11259697|NCT02629861|EG001|Reported Event|Fremanezumab 225/225/225 mg|Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.
11259698|NCT02629861|EG002|Reported Event|Fremanezumab 675 mg/Placebo/Placebo|Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
11259699|NCT02629965|BG000|Baseline|Total|Total randomised participants in the trial.
11259700|NCT02629965|FG000|Participant Flow|Tiotropium 5 μg / Tiotropium + Olodaterol 5/5 μg FDC|"Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) in period 1 and Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks~2 treatments were not separated by wash-out periods."
11259701|NCT02629965|FG001|Participant Flow|Tiotropium + Olodaterol 5/5 μg FDC / Tiotropium 5 μg|"Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 1 and Tiotropium inhalation solution (2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks.~2 treatments were not separated by wash-out periods."
11259702|NCT02629965|OG000|Outcome|Tiotropium 5 μg|Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
11259703|NCT02629965|OG001|Outcome|Tiotropium + Olodaterol 5/5 μg|Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
11259704|NCT02629965|EG000|Reported Event|Tiotropium 5|Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium fixed dose combination of 2.5 μg per actuation once a day in the morning for 6 weeks.
11259705|NCT02629965|EG001|Reported Event|Tiotropium + Olodaterol 5/5|Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium + Olodaterol fixed dose combination of 2.5/2.5 μg per actuation once a day in the morning for 6 weeks.
11259706|NCT02629991|BG000|Baseline|Intranasal Oxytocin|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259707|NCT02629991|BG001|Baseline|Matched Placebo|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259708|NCT02629991|BG002|Baseline|Total|Total of all reporting groups
11259709|NCT02629991|FG000|Participant Flow|Intranasal Oxytocin|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259710|NCT02629991|FG001|Participant Flow|Matched Placebo|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259711|NCT02629991|OG000|Outcome|Intranasal Oxytocin|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259712|NCT02629991|OG001|Outcome|Matched Placebo|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259713|NCT02629991|OG000|Outcome|Intranasal Oxytocin (IN-OXT)|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259714|NCT02629991|OG000|Outcome|Intranasal Oxytocin|"Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).~Intranasal Oxytocin (IN-OXT): Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff)."
11259715|NCT02629991|OG001|Outcome|Matched Placebo|"Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).~Matched Placebo: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff)."
11259716|NCT02629991|EG000|Reported Event|Intranasal Oxytocin (IN-OXT)|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259717|NCT02629991|EG001|Reported Event|Matched Placebo|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
11259718|NCT02630017|BG000|Baseline|ADHD|Adults with ADHD
11259719|NCT02630017|BG001|Baseline|Non-ADHD|Adults without ADHD
11259720|NCT02630017|BG002|Baseline|Total|Total of all reporting groups
11259721|NCT02630017|FG000|Participant Flow|ADHD Methylphenidate First, Placebo Second|Adults with ADHD who received drug (methylphenidate) first, followed by placebo
11259722|NCT02630017|FG001|Participant Flow|ADHD Placebo First, Methylphenidate Second|Adults with ADHD who received placebo first, followed by drug (methylphenidate)
11259723|NCT02630017|FG002|Participant Flow|Non-ADHD Methylphenidate First, Placebo Second|Adults without ADHD who received drug (methylphenidate) first, followed by placebo
11259724|NCT02630017|FG003|Participant Flow|Non-ADHD Placebo First, Methylphenidate Second|Adults without ADHD who received placebo first, followed by drug (methylphenidate)
11259725|NCT02630017|OG000|Outcome|ADHD Subjects, Placebo Condition|Adults with ADHD, under the placebo condition
11259726|NCT02630017|OG001|Outcome|ADHD Subjects, Methylphenidate Condition|Adults with ADHD, under the methylphenidate (drug) condition
11259727|NCT02630017|OG002|Outcome|Non-ADHD Subjects, Placebo Condition|Adults without ADHD, under the placebo condition
11259728|NCT02630017|OG003|Outcome|Non-ADHD Subjects, Methylphenidate Condition|Adults without ADHD, under the methylphenidate (drug) condition
11259729|NCT02630017|EG000|Reported Event|ADHD Methylphenidate First, Placebo Second|Adults with ADHD who received drug (methylphenidate) first, followed by placebo
11259730|NCT02630017|EG001|Reported Event|ADHD Placebo First, Methylphenidate Second|Adults with ADHD who received placebo first, followed by drug (methylphenidate)
11259731|NCT02630017|EG002|Reported Event|Non-ADHD Methylphenidate First, Placebo Second|Adults without ADHD who received drug (methylphenidate) first, followed by placebo
11259732|NCT02630017|EG003|Reported Event|Non-ADHD Placebo First, Methylphenidate Second|Adults without ADHD who received placebo first, followed by drug (methylphenidate)
11259733|NCT02630030|BG000|Baseline|Ixazomib|"Patients receive ixazomib PO 3 hours before surgery.~Ixazomib: Given PO"
11259734|NCT02630030|FG000|Participant Flow|Ixazomib|"Patients receive ixazomib PO 3 hours before surgery.~Ixazomib: Given PO"
11259735|NCT02630030|OG000|Outcome|Ixazomib|"Patients receive ixazomib PO 3 hours before surgery.~Ixazomib: Given PO"
11259736|NCT02630030|EG000|Reported Event|Ixazomib|"Patients receive ixazomib PO 3 hours before surgery.~Ixazomib: Given PO"
11259737|NCT02630186|BG000|Baseline|Single Arm Rociletinib and MPDL3280A in Combination|Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV).
11259738|NCT02630186|FG000|Participant Flow|Single Arm Rociletinib and MPDL3280A in Combination|Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV).
11259739|NCT02630186|OG000|Outcome|Single Arm Rociletinib and MPDL3280A in Combination|Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV).
11259740|NCT02630186|EG000|Reported Event|Single Arm Rociletinib and MPDL3280A in Combination|Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV).
11259741|NCT02630251|BG000|Baseline|GSK2820151 3 mg|Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259742|NCT02630251|BG001|Baseline|GSK2820151 6 mg|Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259743|NCT02630251|BG002|Baseline|GSK2820151 12 mg|Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259744|NCT02630251|BG003|Baseline|GSK2820151 20 mg|Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259745|NCT02630251|BG004|Baseline|Total|Total of all reporting groups
11259746|NCT02630251|FG000|Participant Flow|GSK2820151 3 mg|Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259747|NCT02630251|FG001|Participant Flow|GSK2820151 6 mg|Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259748|NCT02630251|FG002|Participant Flow|GSK2820151 12 mg|Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259749|NCT02630251|FG003|Participant Flow|GSK2820151 20 mg|Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259750|NCT02630251|OG000|Outcome|GSK2820151 3 mg|Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259751|NCT02630251|OG001|Outcome|GSK2820151 6 mg|Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259752|NCT02630251|OG002|Outcome|GSK2820151 12 mg|Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259753|NCT02630251|OG003|Outcome|GSK2820151 20 mg|Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259754|NCT02630251|EG000|Reported Event|GSK2820151 3 mg|Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259755|NCT02630251|EG001|Reported Event|GSK2820151 6 mg|Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259756|NCT02630251|EG002|Reported Event|GSK2820151 12 mg|Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259757|NCT02630251|EG003|Reported Event|GSK2820151 20 mg|Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
11259758|NCT02630316|BG000|Baseline|Placebo|"Matching placebo inhaled using an ultrasonic nebulizer four times daily~Placebo: Placebo administered four times daily"
11259759|NCT02630316|BG001|Baseline|Inhaled Treprostinil|"Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily~Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily"
11259760|NCT02630316|BG002|Baseline|Total|Total of all reporting groups
11259761|NCT02630316|FG000|Participant Flow|Placebo|"Matching placebo inhaled using an ultrasonic nebulizer four times daily~Placebo: Placebo administered four times daily"
11259762|NCT02630316|FG001|Participant Flow|Inhaled Treprostinil|"Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily~Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily"
11259763|NCT02630316|OG000|Outcome|Placebo|"Matching placebo inhaled using an ultrasonic nebulizer four times daily~Placebo: Placebo administered four times daily"
11259764|NCT02630316|OG001|Outcome|Inhaled Treprostinil|"Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily~Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily"
11259765|NCT02630316|EG000|Reported Event|Placebo|"Matching placebo inhaled using an ultrasonic nebulizer four times daily~Placebo: Placebo administered four times daily"
11259766|NCT02630316|EG001|Reported Event|Active Inhaled Treprostinil|"Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily~Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily"
11259767|NCT02630563|BG000|Baseline|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
11259768|NCT02630563|FG000|Participant Flow|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
11259769|NCT02630563|OG000|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
11259770|NCT02630563|OG000|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
11259771|NCT02630563|EG000|Reported Event|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
11259772|NCT02630693|BG000|Baseline|Palbociclib (100mg)|"Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 100mg: 100mg PO daily~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259773|NCT02630693|BG001|Baseline|Palbociclib (125mg)|"Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 125mg: 125mg PO daily 3 weeks out of 4~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259774|NCT02630693|BG002|Baseline|Total|Total of all reporting groups
11259775|NCT02630693|FG000|Participant Flow|Palbociclib (100mg)|"Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 100mg: 100mg PO daily~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259776|NCT02630693|FG001|Participant Flow|Palbociclib (125mg)|"Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 125mg: 125mg PO daily 3 weeks out of 4~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259777|NCT02630693|OG000|Outcome|Palbociclib (100mg)|"Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 100mg: 100mg PO daily~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259778|NCT02630693|OG001|Outcome|Palbociclib (125mg)|"Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 125mg: 125mg PO daily 3 weeks out of 4~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259779|NCT02630693|EG000|Reported Event|Palbociclib (100mg)|"Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 100mg: 100mg PO daily~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259780|NCT02630693|EG001|Reported Event|Palbociclib (125mg)|"Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules~Palbociclib 125mg: 125mg PO daily 3 weeks out of 4~Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules"
11259781|NCT02630706|BG000|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259782|NCT02630706|BG001|Baseline|Ertugliflozin 15 mg|Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259783|NCT02630706|BG002|Baseline|Placebo|Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259784|NCT02630706|BG003|Baseline|Total|Total of all reporting groups
11259785|NCT02630706|FG000|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259786|NCT02630706|FG001|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259787|NCT02630706|FG002|Participant Flow|Placebo|Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259788|NCT02630706|OG000|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259789|NCT02630706|OG001|Outcome|Ertugliflozin 15 mg|Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259790|NCT02630706|OG002|Outcome|Placebo|Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259791|NCT02630706|EG000|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259792|NCT02630706|EG001|Reported Event|Ertugliflozin 15 mg|Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259793|NCT02630706|EG002|Reported Event|Placebo|Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
11259794|NCT02630719|BG000|Baseline|Timolol Eye Drops First|"Treatment with timolol eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by Artificial tears at the onset of an acute migraine headache for the next 2 months.~Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes."
11259795|NCT02630719|BG001|Baseline|Artifical Tears First|"Treatment with artificial eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by timolol eye drops at the onset of an acute migraine headache for the next 2 months.~Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes."
11259796|NCT02630719|BG002|Baseline|Total|Total of all reporting groups
11259797|NCT02630719|FG000|Participant Flow|Timolol Eye Drops First|"Timolol ophthalmic solution 0.5% first, then Artificial Tears~Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.~Each intervention period is 2 months with a 4 day washout period in between."
11259798|NCT02630719|FG001|Participant Flow|Artificial Tears First|"Artificial tears first, then timolol ophthalmic solution 0.5%~Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.~Each intervention period is 2 months with a 4 day washout period in between."
11259799|NCT02630719|OG000|Outcome|Timolol Eye Drops|"Treatment with timolol eye drops at the onset of an acute migraine headache~Timolol eye drops: eye drops"
11259800|NCT02630719|OG001|Outcome|Artificial Tears|"Treatment with artificial eye drops at the onset of an acute migraine headache~Artificial tears: Placebo drop"
11259801|NCT02630719|EG000|Reported Event|Timolol Eye Drops|"Treatment with timolol eye drops at the onset of an acute migraine headache~Timolol eye drops: eye drops"
11259802|NCT02630719|EG001|Reported Event|Artificial Tears|"Treatment with artificial eye drops at the onset of an acute migraine headache~Artificial tears: Placebo drop"
11259803|NCT02630953|BG000|Baseline|Original Tailored Intervention|"This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).~Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety)."
11259804|NCT02630953|BG001|Baseline|Enhanced Tailored Intervention|"We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.~Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring."
11259805|NCT02630953|BG002|Baseline|Total|Total of all reporting groups
11259806|NCT02630953|FG000|Participant Flow|Original Tailored Intervention|"This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).~Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety)."
11286627|NCT02891070|EG000|Reported Event|Tisseel|Tisseel (FS VH S/D 500 s-apr), single use treatment, was administered intra-operatively with sutures during dural closure. Product was applied with cannula by dripping in a thin and continuous layer with a 5 mm overlap on each side of the sutured line, ensuring that all suture holes were covered.
11286628|NCT02891070|EG001|Reported Event|DuraSeal|DuraSeal Dural Sealant, single use treatment, was administered intra-operatively with sutures during dural closure. The product was applied with the DuraSeal System Applicator by spraying a thin (1 - 2 mm) coating, ensuring that all suture holes were covered.
11337428|NCT03584100|OG001|Outcome|Difference in Hand Volume, Axillary Lymph Node Dissection (ALND) vs Contralateral Arms, Sling|Mean change in hand volume 30 minutes after placement of the pneumatic tourniquet, between axillary lymph node dissection (ALND) arm and contralateral arm, both in the sling position.
11337429|NCT03584100|EG000|Reported Event|Tourniquet 8000 Arm|Both arms of participants (Auxillary lymph node dissection (ALND) and other contralateral) were used.
11337430|NCT03585244|BG000|Baseline|Individuals With Prader-Willi Syndrome|"Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months~weekly weight: weekly weight data collection for six months"
11337431|NCT03585244|FG000|Participant Flow|Individuals With Prader-Willi Syndrome|"Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months~weekly weight: weekly weight data collection for six months"
11259807|NCT02630953|FG001|Participant Flow|Enhanced Tailored Intervention|"We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.~Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring."
11259808|NCT02630953|OG000|Outcome|Original Tailored Intervention|"This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).~Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety)."
11259809|NCT02630953|OG001|Outcome|Enhanced Tailored Intervention|"We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.~Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring."
11259810|NCT02630953|EG000|Reported Event|Original Tailored Intervention|"This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).~Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety)."
11259811|NCT02630953|EG001|Reported Event|Enhanced Tailored Intervention|"We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.~Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring."
11259812|NCT02630966|BG000|Baseline|Group 1: Vedolizumab IV 300 mg + Placebo|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.
11259813|NCT02630966|BG001|Baseline|Group 2: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
11259814|NCT02630966|BG002|Baseline|Total|Total of all reporting groups
11259815|NCT02630966|FG000|Participant Flow|Group 1: Vedolizumab IV 300 mg + Placebo|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.
11259816|NCT02630966|FG001|Participant Flow|Group 2: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
11259817|NCT02630966|OG000|Outcome|Group 1: Vedolizumab IV 300 mg + Placebo|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.
11259818|NCT02630966|OG001|Outcome|Group 2: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
11259819|NCT02630966|EG000|Reported Event|Group 1: Vedolizumab IV 300 mg + Placebo|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.
11259820|NCT02630966|EG001|Reported Event|Group 2: Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
11259821|NCT02630992|BG000|Baseline|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
11259822|NCT02630992|FG000|Participant Flow|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
11259823|NCT02630992|OG000|Outcome|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
11259824|NCT02630992|EG000|Reported Event|Amoxicillin-clavulanate Potassium|amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg in two divided doses for 10 days; oral, liquid (formulation 2)
11259825|NCT02631057|BG000|Baseline|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
11259826|NCT02631057|BG001|Baseline|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
11259827|NCT02631057|BG002|Baseline|Total|Total of all reporting groups
11259828|NCT02631057|FG000|Participant Flow|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
11259829|NCT02631057|FG001|Participant Flow|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
11259830|NCT02631057|OG000|Outcome|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
11259831|NCT02631057|OG001|Outcome|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
11259832|NCT02631057|EG000|Reported Event|Dabigatran Etexilate [Prazaxa®]|The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
11259833|NCT02631057|EG001|Reported Event|Warfarin|Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
11259834|NCT02631525|BG000|Baseline|REM-PRO|"Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.~Propofol: Total intravenous anesthesia based on propofol"
11259835|NCT02631525|BG001|Baseline|REM-DES|"Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.~Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring"
11259836|NCT02631525|BG002|Baseline|Total|Total of all reporting groups
11259837|NCT02631525|FG000|Participant Flow|REM-PRO|"Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.~Propofol: Total intravenous anesthesia based on propofol"
11259838|NCT02631525|FG001|Participant Flow|REM-DES|"Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.~Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring"
11259839|NCT02631525|OG000|Outcome|REM-PRO|"Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.~Propofol: Total intravenous anesthesia based on propofol"
11259840|NCT02631525|OG001|Outcome|REM-DES|"Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.~Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring"
11259841|NCT02631525|EG000|Reported Event|REM-PRO|"Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.~Propofol: Total intravenous anesthesia based on propofol"
11259842|NCT02631525|EG001|Reported Event|REM-DES|"Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.~Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring"
11259843|NCT02631538|BG000|Baseline|Placebo|Participants received belimumab matching placebo weekly subcutaneous injections up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment General Follow-Up (GFU) period.
11259844|NCT02631538|BG001|Baseline|Belimumab + Rituximab Co-administration Therapy|Participants received belimumab 200 milligrams (mg) weekly subcutaneous injections for 24 weeks followed by belimumab matching placebo injections weekly up to Week 52; along with rituximab 1000 mg intravenous infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11337432|NCT03585244|OG000|Outcome|Individuals With Prader-Willi Syndrome|"Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months~weekly weight: weekly weight data collection for six months"
11259845|NCT02631538|BG002|Baseline|Belimumab Monotherapy|Participants received 200 mg weekly subcutaneous injections of belimumab up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259846|NCT02631538|BG003|Baseline|Rituximab Monotherapy|Participants received 1000 mg intravenous rituximab infusions at Weeks 8 and 10 and weekly subcutaneous injections of belimumab matching placebo up to Week 52 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259847|NCT02631538|BG004|Baseline|Total|Total of all reporting groups
11259848|NCT02631538|FG000|Participant Flow|Placebo|Participants received belimumab matching placebo weekly subcutaneous injections up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment General Follow-Up (GFU) period.
11259849|NCT02631538|FG001|Participant Flow|Belimumab + Rituximab Co-administration Therapy|Participants received belimumab 200 milligrams (mg) weekly subcutaneous injections for 24 weeks followed by belimumab matching placebo injections weekly up to Week 52; along with rituximab 1000 mg intravenous infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259850|NCT02631538|FG002|Participant Flow|Belimumab Monotherapy|Participants received 200 mg weekly subcutaneous injections of belimumab up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259851|NCT02631538|FG003|Participant Flow|Rituximab Monotherapy|Participants received 1000 mg intravenous rituximab infusions at Weeks 8 and 10 and weekly subcutaneous injections of belimumab matching placebo up to Week 52 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259852|NCT02631538|OG000|Outcome|Placebo|Participants received belimumab matching placebo weekly subcutaneous injections up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment General Follow-Up (GFU) period.
11259853|NCT02631538|OG001|Outcome|Belimumab + Rituximab Co-administration Therapy|Participants received belimumab 200 milligrams (mg) weekly subcutaneous injections for 24 weeks followed by belimumab matching placebo injections weekly up to Week 52; along with rituximab 1000 mg intravenous infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259854|NCT02631538|OG002|Outcome|Belimumab Monotherapy|Participants received 200 mg weekly subcutaneous injections of belimumab up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259855|NCT02631538|OG003|Outcome|Rituximab Monotherapy|Participants received 1000 mg intravenous rituximab infusions at Weeks 8 and 10 and weekly subcutaneous injections of belimumab matching placebo up to Week 52 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259856|NCT02631538|EG000|Reported Event|Placebo|Participants received belimumab matching placebo weekly subcutaneous injections up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment General Follow-Up (GFU) period.
11259857|NCT02631538|EG001|Reported Event|Belimumab + Rituximab Co-administration Therapy|Participants received belimumab 200 milligrams (mg) weekly subcutaneous injections for 24 weeks followed by belimumab matching placebo injections weekly up to Week 52; along with rituximab 1000 mg intravenous infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259858|NCT02631538|EG002|Reported Event|Belimumab Monotherapy|Participants received 200 mg weekly subcutaneous injections of belimumab up to Week 52 and rituximab matching placebo infusions at Weeks 8 and 10 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259859|NCT02631538|EG003|Reported Event|Rituximab Monotherapy|Participants received 1000 mg intravenous rituximab infusions at Weeks 8 and 10 and weekly subcutaneous injections of belimumab matching placebo up to Week 52 in the treatment period. Participants then entered in a 16-week no-treatment GFU period.
11259860|NCT02631551|BG000|Baseline|GSP 301 NS|2 sprays in each nostril twice daily for 14 days
11259861|NCT02631551|BG001|Baseline|Olopatadine HCl NS|2 sprays in each nostril twice daily for 14 days
11259862|NCT02631551|BG002|Baseline|Mometasone Furoate NS|2 sprays in each nostril twice daily for 14 days
11259863|NCT02631551|BG003|Baseline|GSP 301 Placebo NS|2 sprays in each nostril twice daily for 14 days
11259864|NCT02631551|BG004|Baseline|Total|Total of all reporting groups
11259865|NCT02631551|FG000|Participant Flow|GSP 301 NS|2 sprays in each nostril twice daily for 14 days
11259866|NCT02631551|FG001|Participant Flow|Olopatadine HCl NS|2 sprays in each nostril twice daily for 14 days
11259867|NCT02631551|FG002|Participant Flow|Mometasone Furoate NS|2 sprays in each nostril twice daily for 14 days
11259868|NCT02631551|FG003|Participant Flow|GSP 301 Placebo NS|2 sprays in each nostril twice daily for 14 days
11259869|NCT02631551|OG000|Outcome|GSP 301 NS|2 sprays in each nostril twice daily for 14 days
11259870|NCT02631551|OG001|Outcome|Olopatadine HCl NS|2 sprays in each nostril twice daily for 14 days
11259871|NCT02631551|OG002|Outcome|Mometasone Furoate NS|2 sprays in each nostril twice daily for 14 days
11259872|NCT02631551|OG003|Outcome|GSP 301 Placebo NS|2 sprays in each nostril twice daily for 14 days
11259873|NCT02631551|EG000|Reported Event|GSP 301 NS|2 sprays in each nostril twice daily for 14 days
11259874|NCT02631551|EG001|Reported Event|Olopatadine HCl NS|2 sprays in each nostril twice daily for 14 days
11259875|NCT02631551|EG002|Reported Event|Mometasone Furoate NS|2 sprays in each nostril twice daily for 14 days
11259876|NCT02631551|EG003|Reported Event|GSP 301 Placebo NS|2 sprays in each nostril twice daily for 14 days
11259877|NCT02631590|BG000|Baseline|Combination Therapy|"Treatment Plan: Cisplatin (25 mg/m^2 ) + Gemcitabine (1000 mg/m^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.~Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.~Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.~Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days."
11259878|NCT02631590|FG000|Participant Flow|Combination Therapy|"Treatment Plan: Cisplatin (25 mg/m^2 ) + Gemcitabine (1000 mg/m^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.~Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.~Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.~Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days."
11259879|NCT02631590|OG000|Outcome|Combination Therapy|"Treatment Plan: Cisplatin (25 mg/m^2 ) + Gemcitabine (1000 mg/m^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.~Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.~Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.~Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days."
11259880|NCT02631590|EG000|Reported Event|Combination Therapy|"Treatment Plan: Cisplatin (25 mg/m^2 ) + Gemcitabine (1000 mg/m^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.~Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.~Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.~Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days."
11259881|NCT02631746|BG000|Baseline|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacogenomic Study: Correlative studies"
11259882|NCT02631746|FG000|Participant Flow|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacogenomic Study: Correlative studies"
11259883|NCT02631746|OG000|Outcome|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacogenomic Study: Correlative studies"
11259884|NCT02631746|EG000|Reported Event|Treatment (Nivolumab)|"Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacogenomic Study: Correlative studies"
11259885|NCT02631772|BG000|Baseline|Late Cohort, Arm 1|"LDV/SOF monotherapy x 12 weeks~Sofosbuvir/Ledipasvir x 12 weeks"
11259886|NCT02631772|BG001|Baseline|Late Cohort, Arm 2|"LDV/SOF+ribavirin x 12 weeks~Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks"
11259887|NCT02631772|BG002|Baseline|Total|Total of all reporting groups
11259888|NCT02631772|FG000|Participant Flow|Late Cohort, Arm 1|"LDV/SOF monotherapy x 12 weeks~Sofosbuvir/Ledipasvir x 12 weeks"
11259889|NCT02631772|FG001|Participant Flow|Late Cohort, Arm 2|"LDV/SOF+ribavirin x 12 weeks~Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks"
11259890|NCT02631772|OG000|Outcome|Late Cohort, Arm 1|"LDV/SOF monotherapy x 12 weeks~Sofosbuvir/Ledipasvir x 12 weeks"
11259891|NCT02631772|OG001|Outcome|Late Cohort, Arm 2|"LDV/SOF+ribavirin x 12 weeks~Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks"
11259892|NCT02631772|EG000|Reported Event|Late Cohort, Arm 1|"LDV/SOF monotherapy x 12 weeks~Sofosbuvir/Ledipasvir x 12 weeks"
11259893|NCT02631772|EG001|Reported Event|Late Cohort, Arm 2|"LDV/SOF+ribavirin x 12 weeks~Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks"
11259894|NCT02631850|BG000|Baseline|Traditional CI Therapy|"Participants will receive a 35-hour dose of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.~Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis."
11259895|NCT02631850|BG001|Baseline|Gaming CI Therapy|"15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.~Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis."
11259896|NCT02631850|BG002|Baseline|Gaming CI Therapy With Additional Contact Via Video Conference|"This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.~Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference."
11337433|NCT03585244|EG000|Reported Event|Individuals With Prader-Willi Syndrome|"Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months~weekly weight: weekly weight data collection for six months"
11337434|NCT03585296|BG000|Baseline|ATI-502|"ATI-502 topical solution applied daily for four weeks.~ATI-502: Topical Solution"
11337435|NCT03585296|FG000|Participant Flow|ATI-502|0.46% Solution applied twice a day for 28 days
11337436|NCT03585296|OG000|Outcome|ATI-502|"ATI-502 topical solution applied daily for four weeks.~ATI-502: Topical Solution"
11259897|NCT02631850|BG003|Baseline|Traditional Occupational Therapy/Physical Therapy|"Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.~Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity."
11259898|NCT02631850|BG004|Baseline|Total|Total of all reporting groups
11259899|NCT02631850|FG000|Participant Flow|Traditional CI Therapy|"Participants will receive a 35-hour dose of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.~Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis."
11259900|NCT02631850|FG001|Participant Flow|Gaming CI Therapy|"15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.~Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis."
11259901|NCT02631850|FG002|Participant Flow|Gaming CI Therapy With Additional Contact Via Video Conference|"This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.~Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference."
11259902|NCT02631850|FG003|Participant Flow|Traditional Occupational Therapy/Physical Therapy|"Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.~Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity."
11259903|NCT02631850|OG000|Outcome|Traditional CI Therapy|"Participants will receive a 35-hour dose of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.~Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis."
11259904|NCT02631850|OG001|Outcome|Gaming CI Therapy|"15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.~Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis."
11259905|NCT02631850|OG002|Outcome|Gaming CI Therapy With Additional Contact Via Video Conference|"This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.~Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference."
11286629|NCT02891174|BG000|Baseline|Ibuprofen Followed by Acetaminophen|"Ibuprofen administered immediately post-partum, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours followed by acetaminophen, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours.~Ibuprofen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.~Acetaminophen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen."
11259906|NCT02631850|OG003|Outcome|Traditional Occupational Therapy/Physical Therapy|"Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.~Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity."
11259907|NCT02631850|OG003|Outcome|Traditional Occupational Therapy/Physical Therapy|"Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on activities of daily living (ADLs) with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.~Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity."
11259908|NCT02631850|EG000|Reported Event|Traditional CI Therapy|"Participants will receive a 35-hour dose of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.~Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis."
11259909|NCT02631850|EG001|Reported Event|Gaming CI Therapy|"15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.~Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis."
11259910|NCT02631850|EG002|Reported Event|Gaming CI Therapy With Additional Contact Via Video Conference|"This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.~Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference."
11259911|NCT02631850|EG003|Reported Event|Traditional Occupational Therapy/Physical Therapy|"Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.~Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity."
11259912|NCT02631876|BG000|Baseline|Mirvetuximab Soravtansine|Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
11259913|NCT02631876|BG001|Baseline|Investigator's Choice (IC) Chemotherapy|Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
11259914|NCT02631876|BG002|Baseline|Total|Total of all reporting groups
11337437|NCT03585296|EG000|Reported Event|ATI-502|"ATI-502 topical solution applied daily for four weeks.~ATI-502: Topical Solution"
11337438|NCT03585504|BG000|Baseline|Intervention Group|"Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11259915|NCT02631876|FG000|Participant Flow|Mirvetuximab Soravtansine|Participants received mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
11259916|NCT02631876|FG001|Participant Flow|Investigator's Choice (IC) Chemotherapy|Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
11259917|NCT02631876|OG000|Outcome|Mirvetuximab Soravtansine|Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
11259918|NCT02631876|OG001|Outcome|Investigator's Choice (IC) Chemotherapy|Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
11259919|NCT02631876|OG000|Outcome|Mirvetuximab Soravtansine|Participants received MIRV mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
11259920|NCT02631876|EG000|Reported Event|Mirvetuximab Soravtansine|Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
11259921|NCT02631876|EG001|Reported Event|Investigator's Choice (IC) Chemotherapy|Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
11259922|NCT02631954|BG000|Baseline|TR Group|"Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg~Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once~Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once"
11259923|NCT02631954|BG001|Baseline|RT Group|"Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)~Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once~Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once"
11259924|NCT02631954|BG002|Baseline|Total|Total of all reporting groups
11259925|NCT02631954|FG000|Participant Flow|TR Group|"Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg~Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once~Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once"
11259926|NCT02631954|FG001|Participant Flow|RT Group|"Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)~Vorico Injection 200mg(Voriconazole): Vorico Injection 200mg(Voriconazole) to administered intravenously once~Vfend®(Voriconazole) IV 200mg: Vfend®(Voriconazole) IV 200mg to administered intravenously once"
11259927|NCT02631954|OG000|Outcome|Reference|"Reference: Vfend® IV 200mg drug~RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I~TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II"
11259928|NCT02631954|OG001|Outcome|Test|"Test: Vorico Injection 200mg(Voriconazole) drug~RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II~TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I"
11259929|NCT02631954|EG000|Reported Event|Reference|"Reference: Vfend® IV 200mg drug~RT group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period I~TR group: Vfend®(Voriconazole) IV 200mg to administered intravenously once at Period II"
11259930|NCT02631954|EG001|Reported Event|Test|"Test: Vorico Injection 200mg(Voriconazole) drug~RT group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period II~TR group: Vorico Injection 200mg(Voriconazole) to administered intravenously once at Period I"
11259931|NCT02632110|BG000|Baseline|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259932|NCT02632110|BG001|Baseline|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259933|NCT02632110|BG002|Baseline|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259934|NCT02632110|BG003|Baseline|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259935|NCT02632110|BG004|Baseline|VEH 60 Min 10 mW|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259936|NCT02632110|BG005|Baseline|Total|Total of all reporting groups
11259937|NCT02632110|FG000|Participant Flow|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application"
11259938|NCT02632110|FG001|Participant Flow|ALA 25 Min 10 mW|"Aminolevulinic acid photodynamic therapy (ALA-PDT), 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle (MN): one actinic keratosis (AK) Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~Investigational Blue Light (IBL) 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259939|NCT02632110|FG002|Participant Flow|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259940|NCT02632110|FG003|Participant Flow|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259941|NCT02632110|FG004|Participant Flow|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
11259942|NCT02632110|FG005|Participant Flow|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259943|NCT02632110|FG006|Participant Flow|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259944|NCT02632110|FG007|Participant Flow|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259945|NCT02632110|FG008|Participant Flow|MN + VEH 60 Min 10 mW|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application"
11259946|NCT02632110|FG009|Participant Flow|VEH 60 Min 10 mW|"Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259947|NCT02632110|OG000|Outcome|MN + ALA 25 Min 10 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
11259948|NCT02632110|OG001|Outcome|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259949|NCT02632110|OG002|Outcome|MN + ALA 25 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259950|NCT02632110|OG003|Outcome|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259951|NCT02632110|OG004|Outcome|MN + ALA 60 Min 10mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
11259952|NCT02632110|OG005|Outcome|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259953|NCT02632110|OG006|Outcome|MN + ALA 60 Min 20 mW|"Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259954|NCT02632110|OG007|Outcome|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259955|NCT02632110|OG008|Outcome|MN + VEH|"Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds~Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application."
11259956|NCT02632110|OG009|Outcome|VEH PDT|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259957|NCT02632110|EG000|Reported Event|ALA 25 Min 10 mW|"ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259958|NCT02632110|EG001|Reported Event|ALA 25 Min 20 mW|"ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259959|NCT02632110|EG002|Reported Event|ALA 60 Min 10 mW|"ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259960|NCT02632110|EG003|Reported Event|ALA 60 Min 20 mW|"ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.~ALA: 20% ALA applied to face prior to light treatment~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.~IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds"
11259961|NCT02632110|EG004|Reported Event|VEH 60 Min 10 mW|"Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.~MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.~Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment~IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds"
11259962|NCT02632526|BG000|Baseline|Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg & 1200mg with 6 participants in each dose level
11259963|NCT02632526|BG001|Baseline|Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg & 300 mg with 6 participants in each dose level
11259964|NCT02632526|BG002|Baseline|Part B (Amorphous Suspension)|Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg & 600 mg with 6 participants in each dose level
11259965|NCT02632526|BG003|Baseline|Placebo - Part A (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)
11259966|NCT02632526|BG004|Baseline|Placebo - Part A (Crystalline Suspension)|2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
11259967|NCT02632526|BG005|Baseline|Placebo - Part B (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
11259968|NCT02632526|BG006|Baseline|Total|Total of all reporting groups
11259969|NCT02632526|FG000|Participant Flow|Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg & 1200mg with 6 participants in each dose level
11259970|NCT02632526|FG001|Participant Flow|Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg & 300 mg with 6 participants in each dose level
11259971|NCT02632526|FG002|Participant Flow|Part B (Amorphous Suspension)|Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg & 600 mg with 6 participants in each dose level
11259972|NCT02632526|FG003|Participant Flow|Placebo - Part A (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)
11259973|NCT02632526|FG004|Participant Flow|Placebo - Part A (Crystalline Suspension)|2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
11259974|NCT02632526|FG005|Participant Flow|Placebo - Part B (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
11259975|NCT02632526|OG000|Outcome|Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg & 1200mg with 6 participants in each dose level
11259976|NCT02632526|OG001|Outcome|Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg & 300 mg with 6 participants in each dose level
11259977|NCT02632526|OG002|Outcome|Part B (Amorphous Suspension)|Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg & 600 mg with 6 participants in each dose level
11259978|NCT02632526|OG003|Outcome|Placebo - Part A (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)
11259979|NCT02632526|OG004|Outcome|Placebo - Part A (Crystalline Suspension)|2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
11259980|NCT02632526|OG005|Outcome|Placebo - Part B (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
11259981|NCT02632526|OG000|Outcome|25 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state
11259982|NCT02632526|OG001|Outcome|50 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state
11259983|NCT02632526|OG002|Outcome|100 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state
11259984|NCT02632526|OG003|Outcome|300 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 300 mg in amorphous state
11259985|NCT02632526|OG004|Outcome|600 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 600 mg in amorphous state
11259986|NCT02632526|OG005|Outcome|1200 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 1200 mg in amorphous state
11259987|NCT02632526|OG006|Outcome|100 mg - Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state
11259988|NCT02632526|OG007|Outcome|300 mg - Part A (Crystalline Suspension)|"Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state.~Presented only based on 5 subjects data."
11259989|NCT02632526|OG000|Outcome|60 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts
11259990|NCT02632526|OG001|Outcome|180 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts
11259991|NCT02632526|OG002|Outcome|360 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts
11259992|NCT02632526|OG003|Outcome|600 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 600 mg in amorphous state in 6 cohorts
11259993|NCT02632526|OG000|Outcome|100 mg - AZD5718|Participants received single dose of oral suspension of AZD5718 100 mg in amorphous/crystalline state
11259994|NCT02632526|OG001|Outcome|300 mg - AZD5718|Participants received single dose of oral suspension of AZD5718 300 mg in amorphous/crystalline state
11259995|NCT02632526|OG000|Outcome|100 mg AZD5718|Participants received single dose of oral suspension of AZD5718 100 mg in amorphous/crystalline state
11259996|NCT02632526|OG000|Outcome|180mg-Part B (Amorphous Suspension) -Fed State (Day 9)|Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts under fed condition
11259997|NCT02632526|OG001|Outcome|180mg -Part B (Amorphous Suspension) -Fasted State (Day 10)|Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts under fed condition
11259998|NCT02632526|OG006|Outcome|Placebo - Part A (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)
11259999|NCT02632526|OG007|Outcome|100 mg - Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state
11260000|NCT02632526|OG008|Outcome|300 mg - Part A (Crystalline Suspension)|"Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state.~Presented only based on 5 subjects data."
11260001|NCT02632526|OG009|Outcome|Placebo - Part A (Crystalline Suspension)|2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
11260002|NCT02632526|OG004|Outcome|Placebo - Part B (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
11260003|NCT02632526|EG000|Reported Event|25 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state
11260004|NCT02632526|EG001|Reported Event|50 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state
11260005|NCT02632526|EG002|Reported Event|100 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state
11260006|NCT02632526|EG003|Reported Event|300 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 300 mg in amorphous state
11260007|NCT02632526|EG004|Reported Event|600 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 600 mg in amorphous state
11260008|NCT02632526|EG005|Reported Event|1200 mg - Part A (Amorphous Suspension)|Participants received single dose of oral suspension of AZD5718 1200 mg in amorphous state
11260009|NCT02632526|EG006|Reported Event|Placebo - Part A (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)
11260010|NCT02632526|EG007|Reported Event|100 mg - Part A (Crystalline Suspension)|Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state
11260011|NCT02632526|EG008|Reported Event|300 mg - Part A (Crystalline Suspension)|"Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state.~Presented only based on 5 subjects data."
11260012|NCT02632526|EG009|Reported Event|Placebo - Part A (Crystalline Suspension)|2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
11260013|NCT02632526|EG010|Reported Event|60 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts
11260014|NCT02632526|EG011|Reported Event|180 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts
11260015|NCT02632526|EG012|Reported Event|360 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts
11260016|NCT02632526|EG013|Reported Event|600 mg - Part B (Amorphous Suspension)|Participants received multiple doses of oral suspension of AZD5718 600 mg in amorphous state in 6 cohorts
11260017|NCT02632526|EG014|Reported Event|Placebo - Part B (Amorphous Suspension)|2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
11286630|NCT02891174|BG001|Baseline|Acetaminophen Followed by Ibuprofen|"Acetaminophen administered immediately post-partum, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours followed by ibuprofen, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours.~Ibuprofen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.~Acetaminophen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen."
11286631|NCT02891174|BG002|Baseline|Total|Total of all reporting groups
11286632|NCT02891174|FG000|Participant Flow|Ibuprofen Followed by Acetaminophen|Period 1: Ibuprofen 600 mg every 6 hours for 24 hours Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout
11286633|NCT02891174|FG001|Participant Flow|Acetaminophen Followed by Ibuprofen|Period 1: Acetaminophen 650 mg every 6 hours for 24 hours Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout
11286634|NCT02891174|OG000|Outcome|Ibuprofen|Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended ibuprofen period.
11286635|NCT02891174|OG001|Outcome|Acetaminophen|Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended acetaminophen period.
11286636|NCT02891174|OG000|Outcome|Ibuprofen|Ibuprofen was the first intervention and pain scales were administered only during this first period.
11286637|NCT02891174|OG001|Outcome|Acetaminophen|Acetaminophen was the first intervention and pain scales were administered only during this first period.
11286638|NCT02891174|OG000|Outcome|Ibuprofen Followed by Acetaminophen|Period 1: Ibuprofen 600 mg every 6 hours for 24 hours. Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout period.
11286639|NCT02891174|OG001|Outcome|Acetaminophen Followed by Ibuprofen|Period 1: Acetaminophen 650 mg every 6 hours for 24 hours. Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout period.
11286640|NCT02891174|EG000|Reported Event|Ibuprofen|Women who received ibuprofen intervention
11286641|NCT02891174|EG001|Reported Event|Acetaminophen|Women who received acetaminophen intervention
11286642|NCT02891200|BG000|Baseline|Healthcare Professional (HCP) Arm|"Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11286643|NCT02891200|BG001|Baseline|HCP Plus Peer Arm|"HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker.~Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11286644|NCT02891200|BG002|Baseline|Total|Total of all reporting groups
11286645|NCT02891200|FG000|Participant Flow|Healthcare Professional (HCP) Arm|"Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide Chronic Obstructive Pulmonary Disease (COPD) self-management education and support via an in-person session and written materials .~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11286646|NCT02891200|FG001|Participant Flow|HCP Plus Peer Arm|"HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker.~Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11337439|NCT03585504|BG001|Baseline|Control Group|"These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11260018|NCT02632552|BG000|Baseline|Technology-assisted Care Transition Arm|"In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting~Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting"
11260019|NCT02632552|BG001|Baseline|Active Attention Control|"In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting~Active attention control: In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting"
11260020|NCT02632552|BG002|Baseline|Total|Total of all reporting groups
11260021|NCT02632552|FG000|Participant Flow|Intervention|In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
11260022|NCT02632552|FG001|Participant Flow|Active Attention Control|In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
11260023|NCT02632552|OG000|Outcome|Intervention|Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
11260024|NCT02632552|OG001|Outcome|Active Attention Control|In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
11260025|NCT02632552|OG000|Outcome|Intervention|In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
11260026|NCT02632552|EG000|Reported Event|Technology-assisted Care Transition Arm|"In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting~Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting"
11260027|NCT02632552|EG001|Reported Event|Active Attention Control|"In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting~Active attention control: In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting"
11260028|NCT02632747|BG000|Baseline|Sequence A: 25 mg Empagliflozin / Placebo|During dosing Period 1, participants were administered 1 tablet of 25 milligram (mg) empagliflozin once daily as single oral dose for 4 weeks added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg ramipril or to their maximum tolerated dose. This was followed by a 4-week wash-out period with background treatment of open-label ramipril administered orally as capsule once or twice daily as prescribed by the investigator,and then followed by 4 weeks of dosing period 2 of 1 tablet matching placebo administered once daily as single oral dose added to open-label Ramipril.
11260029|NCT02632747|BG001|Baseline|Sequence B: Placebo / 25 mg Empagliflozin|During dosing Period 1, participants were administered 1 tablet of matching placebo once daily as single oral dose for 4 weeks added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg ramipril or to their maximum tolerated dose. This was followed by a 4-week wash-out period with background treatment of open-label ramipril administered orally as capsule once or twice daily as prescribed by the investigator,and then followed by 4 weeks of dosing period 2 of 1 tablet of 25 mg empagliflozin administered once daily as single oral dose added to open-label Ramipril.
11260030|NCT02632747|BG002|Baseline|Total|Total of all reporting groups
11260031|NCT02632747|FG000|Participant Flow|Sequence A: 25 mg Empagliflozin / Placebo|During dosing Period 1, participants were administered 1 tablet of 25 milligram (mg) empagliflozin once daily as single oral dose for 4 weeks added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg ramipril or to their maximum tolerated dose. This was followed by a 4-week wash-out period with background treatment of open-label ramipril administered orally as capsule once or twice daily as prescribed by the investigator,and then followed by 4 weeks of dosing period 2 of 1 tablet matching placebo administered once daily as single oral dose added to open-label Ramipril.
11260032|NCT02632747|FG001|Participant Flow|Sequence B: Placebo / 25 mg Empagliflozin|During dosing Period 1, participants were administered 1 tablet of matching placebo once daily as single oral dose for 4 weeks added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg ramipril or to their maximum tolerated dose. This was followed by a 4-week wash-out period with background treatment of open-label ramipril administered orally as capsule once or twice daily as prescribed by the investigator,and then followed by 4 weeks of dosing period 2 of 1 tablet of 25 mg empagliflozin administered once daily as single oral dose added to open-label Ramipril.
11260033|NCT02632747|OG000|Outcome|25 mg Empagliflozin|Participants were administered 1 tablet of 25 milligram (mg) empagliflozin once daily as single oral dose, added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg Ramipril or to their maximum tolerated dose.
11260034|NCT02632747|OG001|Outcome|Placebo|Participants were administered 1 tablet of matching placebo administered once daily as single oral dose, added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg Ramipril or to their maximum tolerated dose.
11260035|NCT02632747|EG000|Reported Event|25 mg Empagliflozin|Participants were administered 1 tablet of 25 milligram (mg) empagliflozin once daily as single oral dose, added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg Ramipril or to their maximum tolerated dose.
11260036|NCT02632747|EG001|Reported Event|Placebo|Participants were administered 1 tablet of matching placebo administered once daily as single oral dose, added to open-label Ramipril, where participants had been dose escalated from 1.25, 5, 7.5, or 10 mg, up to 10 mg Ramipril or to their maximum tolerated dose.
11260037|NCT02632786|BG000|Baseline|NEOD001 24mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 12 months
11260038|NCT02632786|BG001|Baseline|Placebo|Placebo, 0.9% Saline IV every 4 weeks for 12 months
11260039|NCT02632786|BG002|Baseline|Total|Total of all reporting groups
11260040|NCT02632786|FG000|Participant Flow|NEOD001 24mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 12 months
11260041|NCT02632786|FG001|Participant Flow|Placebo|Placebo, 0.9% Saline IV every 4 weeks for 12 months
11260042|NCT02632786|OG000|Outcome|NEOD001 24mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 12 months
11260043|NCT02632786|OG001|Outcome|Placebo|Placebo, 0.9% Saline IV every 4 weeks for 12 months
11260044|NCT02632786|OG000|Outcome|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 12 months
11260045|NCT02632786|EG000|Reported Event|NEOD001 24 mg/kg|24 mg/kg IV every 4 weeks for 12 months
11260046|NCT02632786|EG001|Reported Event|Placebo|0.9% Saline IV every 4 weeks for 12 months
11260047|NCT02632812|BG000|Baseline|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
11260048|NCT02632812|BG001|Baseline|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
11260049|NCT02632812|BG002|Baseline|Total|Total of all reporting groups
11260050|NCT02632812|FG000|Participant Flow|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
11260051|NCT02632812|FG001|Participant Flow|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
11260052|NCT02632812|OG000|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
11260053|NCT02632812|OG001|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
11260054|NCT02632812|EG000|Reported Event|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
11260055|NCT02632812|EG001|Reported Event|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
11260056|NCT02632838|BG000|Baseline|the mHealth Group|The mHealth group asked to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual.
11260057|NCT02632838|BG001|Baseline|the Standard Follow-up Group|The standard follow-up group received regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care in the community health center
11260058|NCT02632838|BG002|Baseline|Total|Total of all reporting groups
11260059|NCT02632838|FG000|Participant Flow|the mHealth Group|"The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also will be asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual.~iHealth BP7-Wireless Blood Pressure Wrist Monitor,: The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor at home. This monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. The Bluetooth sync system allows the monitor to send BP measures and pulse rate to patients' mobile devices. The free iHealth app automatically keeps a history of BP data and gives patient the option to share their blood pressure data with their provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vi"
11260060|NCT02632838|FG001|Participant Flow|the Standard Follow-up Group|The standard follow-up group will receive regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care in the community health center
11260061|NCT02632838|OG000|Outcome|the mHealth Group|The mHealth group asked to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual.
11260062|NCT02632838|OG001|Outcome|the Standard Follow-up Group|The standard follow-up group received regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care in the community health center
11260063|NCT02632838|OG000|Outcome|the mHealth Group|SF-36 scores between the baseline and 6-month later were compared between the mHealth group and the Standard follow-up group.
11260064|NCT02632838|OG001|Outcome|the Standard Follow-up Group|SF-36 scores between the baseline and 6-month later were compared between the mHealth group and the Standard follow-up group.
11260065|NCT02632838|OG000|Outcome|the mHealth Group|MASE scores between the baseline and 6 month later were compared between the mHealth group and the Standard follow-up group.
11260066|NCT02632838|OG001|Outcome|the Standard Follow-up Group|MASE scores between the baseline and 6 month later were compared between the mHealth group and the Standard follow-up group.
11260067|NCT02632838|EG000|Reported Event|the mHealth Group|The mHealth group asked to use iHealth BP7-Wirless Blood Pressure Wrist Monitor on a daily basis at HOME and also asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual.
11260068|NCT02632838|EG001|Reported Event|the Standard Follow-up Group|The standard follow-up group received regular hypertension care as usual which consists nursing assessment, medication management, patient education, follow up and continuing care in the community health center.
11260069|NCT02633020|BG000|Baseline|AMG 714|Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260070|NCT02633020|BG001|Baseline|Placebo|Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260071|NCT02633020|BG002|Baseline|Total|Total of all reporting groups
11260072|NCT02633020|FG000|Participant Flow|AMG 714|Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260073|NCT02633020|FG001|Participant Flow|Placebo|Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260074|NCT02633020|OG000|Outcome|AMG 714|Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260075|NCT02633020|OG001|Outcome|Placebo|Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260076|NCT02633020|EG000|Reported Event|AMG 714|Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260077|NCT02633020|EG001|Reported Event|Placebo|Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.
11260078|NCT02633046|BG000|Baseline|Acthar Gel|All participants receive open-label treatment with Acthar Gel per protocol regimen
11260079|NCT02633046|FG000|Participant Flow|Acthar Gel|"All participants receive open-label treatment with Acthar Gel per protocol regimen:~Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product."
11260080|NCT02633046|OG000|Outcome|Acthar Gel|All participants receive open-label treatment with Acthar Gel per protocol regimen
11260081|NCT02633046|EG000|Reported Event|Acthar Gel|All participants receive open-label treatment with Acthar Gel per protocol regimen
11260082|NCT02633215|BG000|Baseline|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260083|NCT02633215|BG001|Baseline|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260084|NCT02633215|BG002|Baseline|Total|Total of all reporting groups
11260085|NCT02633215|FG000|Participant Flow|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260086|NCT02633215|FG001|Participant Flow|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260087|NCT02633215|OG000|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260088|NCT02633215|OG001|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260089|NCT02633215|EG000|Reported Event|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260090|NCT02633215|EG001|Reported Event|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.~S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy"
11260091|NCT02633306|BG000|Baseline|Transcranial Magnetic Stimulation|"transcranial magnetic stimulation~transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain."
11337440|NCT03585504|BG002|Baseline|Total|Total of all reporting groups
11260092|NCT02633306|FG000|Participant Flow|Transcranial Magnetic Stimulation|"transcranial magnetic stimulation~transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain."
11260093|NCT02633306|OG000|Outcome|Transcranial Magnetic Stimulation|"transcranial magnetic stimulation~transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain."
11260094|NCT02633306|OG000|Outcome|Transcranial Magnetic Stimulation|"All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data~1 has missing data for 7 day post treatment social relationships score"
11260095|NCT02633306|EG000|Reported Event|Transcranial Magnetic Stimulation|"transcranial magnetic stimulation~transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain."
11260096|NCT02633358|BG000|Baseline|Therapeutic Hypothermia|"Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling~Therapeutic hypothermia: Therapeutic hypothermia"
11260097|NCT02633358|BG001|Baseline|Non-Hypothermia|Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
11260098|NCT02633358|BG002|Baseline|Total|Total of all reporting groups
11260099|NCT02633358|FG000|Participant Flow|Therapeutic Hypothermia|"Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling~Therapeutic hypothermia: Therapeutic hypothermia"
11260100|NCT02633358|FG001|Participant Flow|Non-hypothermia|Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
11260101|NCT02633358|OG000|Outcome|Therapeutic Hypothermia|"Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling~Therapeutic hypothermia: Therapeutic hypothermia"
11260102|NCT02633358|OG001|Outcome|Non-hypothermia|"Control group for non-hypothermia.~Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling"
11260103|NCT02633358|OG001|Outcome|Non-hypothermia|Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
11260104|NCT02633358|EG000|Reported Event|Therapeutic Hypothermia|Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.
11260105|NCT02633358|EG001|Reported Event|Non-Hypothermia|Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.
11260106|NCT02633371|BG000|Baseline|Oxybutynin|Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
11260107|NCT02633371|FG000|Participant Flow|Oxybutynin|Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
11260108|NCT02633371|OG000|Outcome|Oxybutynin|Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
11260109|NCT02633371|EG000|Reported Event|Oxybutynin|"Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks~Oxybutynin 3% gel"
11260110|NCT02633488|BG000|Baseline|Placebo, Then Metformin|12 weeks of Placebo tablet 3 x daily, then a 8 week washout, then 12 weeks Metformin tablet 3 X daily
11260111|NCT02633488|BG001|Baseline|Metformin, Then Placebo|12 weeks of Metformin tablet 850 mg 3 x daily, then 8 week washout , then 12 weeks Placebo tablet 3X daily
11260112|NCT02633488|BG002|Baseline|Total|Total of all reporting groups
11260113|NCT02633488|FG000|Participant Flow|Placebo, Then Metformin|12 weeks of Placebo tablet 3 x daily then 8 week washout then 12 weeks of metformin 500 mg 3x daily
11260114|NCT02633488|FG001|Participant Flow|Metformin, Then Placebo|12 weeks of metformin 500 mg tablet 3 x daily then 8 week washout then 12 weeks of placebo 3x daily
11260115|NCT02633488|OG000|Outcome|Pre and Post Placebo 12 Weeks|measured % dilation in response to shear stress before and after 2 hour insulin clamp which is performed before and after 12 weeks of Placebo tablets 3X daily
11260116|NCT02633488|OG001|Outcome|Pre and Post Metformin 12 Weeks|measured % dilation in response to shear stress before and after 2 hour insulin clamp which is performed before and after 12 weeks of Metformin tablets 3X daily
11260117|NCT02633488|EG000|Reported Event|Placebo|"12 weeks of Placebo tablet 3 x daily~Placebos: A 12 week single blind placebos"
11260118|NCT02633488|EG001|Reported Event|Metformin|"12 weeks of Metformin tablet 850 mg 3 x daily~metformin: A 12 week single blind metformin"
11260119|NCT02633501|BG000|Baseline|Subset 2 - P03277 0.025 mmol/kg/Gadobenate Dimeglumine|P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260120|NCT02633501|BG001|Baseline|Subset 2 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine|P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260121|NCT02633501|BG002|Baseline|Subset 2 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine|P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260122|NCT02633501|BG003|Baseline|Subset 2 - P03277 0.2 mmol/kg/Gadobenate Dimeglumine|P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260123|NCT02633501|BG004|Baseline|Subset 1 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine|P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260124|NCT02633501|BG005|Baseline|Subset 1 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine|P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260125|NCT02633501|BG006|Baseline|Total|Total of all reporting groups
11260126|NCT02633501|FG000|Participant Flow|Subset 1 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260127|NCT02633501|FG001|Participant Flow|Subset 1 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260128|NCT02633501|FG002|Participant Flow|Subset 2 - P03277 0.025 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.025 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260129|NCT02633501|FG003|Participant Flow|Subset 2 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260130|NCT02633501|FG004|Participant Flow|Subset 2 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260131|NCT02633501|FG005|Participant Flow|Subset 2 - P03277 0.2 mmol/kg/Gadobenate Dimeglumine|"P03277 (0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa~P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second~Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second"
11260132|NCT02633501|OG000|Outcome|P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 1|P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260133|NCT02633501|OG001|Outcome|P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 1|P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260134|NCT02633501|OG002|Outcome|P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 1|P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260135|NCT02633501|OG003|Outcome|P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 1|P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260136|NCT02633501|OG004|Outcome|P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 2|P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260137|NCT02633501|OG005|Outcome|P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 2|P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260138|NCT02633501|OG006|Outcome|P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 2|P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260139|NCT02633501|OG007|Outcome|P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 2|P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260140|NCT02633501|OG008|Outcome|P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 3|P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260141|NCT02633501|OG009|Outcome|P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 3|P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260142|NCT02633501|OG010|Outcome|P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 3|P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260143|NCT02633501|OG011|Outcome|P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 3|P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
11260144|NCT02633501|EG000|Reported Event|P03277 0.025 mmol/kg|Patients who received one injection of P03277 0.025 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2).
11260145|NCT02633501|EG001|Reported Event|P03277 0.05 mmol/kg|Patients who received one injection of P03277 0.05 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2).
11260146|NCT02633501|EG002|Reported Event|P03277 0.1 mmol/kg|Patients who received one injection of P03277 0.1 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2)
11260147|NCT02633501|EG003|Reported Event|P03277 0.2 mmol/kg|Patients who received one injection of P03277 0.2 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2)
11260148|NCT02633501|EG004|Reported Event|Gadobenate Dimeglumine|Patients who received one injection of gadobenate dimeglumine regardless of injection order vs P03277 (subset 1 + subset 2).
11260149|NCT02633527|BG000|Baseline|Placebo|Treatment A: Placebo was administered once daily
11260150|NCT02633527|BG001|Baseline|100mg SPN-812|Treatment B: 100mg SPN-812 was administered once daily and compared to placebo
11260151|NCT02633527|BG002|Baseline|200mg SPN-812|Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
11260152|NCT02633527|BG003|Baseline|300mg SPN-812|Treatment D: 300mg SPN-812 was administered once daily and compared to placebo
11260153|NCT02633527|BG004|Baseline|400mg SPN-812|Treatment E: 400mg SPN-812 was administered once daily and compared to placebo
11260154|NCT02633527|BG005|Baseline|Total|Total of all reporting groups
11260155|NCT02633527|FG000|Participant Flow|Placebo|Treatment A: Placebo was administered once daily
11260156|NCT02633527|FG001|Participant Flow|100mg SPN-812|Treatment B: 100mg SPN-812 was administered once daily and compared to placebo
11260157|NCT02633527|FG002|Participant Flow|200mg SPN-812|Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
11260158|NCT02633527|FG003|Participant Flow|300mg SPN-812|Treatment D: 300mg SPN-812 was administered once daily and compared to placebo
11260159|NCT02633527|FG004|Participant Flow|400mg SPN-812|Treatment E: 400mg SPN-812 was administered once daily and compared to placebo
11260160|NCT02633527|OG000|Outcome|Placebo|Treatment A: Placebo was administered once daily
11260161|NCT02633527|OG001|Outcome|100mg SPN-812|Treatment B: 100mg SPN-812 was administered once daily and compared to placebo
11260162|NCT02633527|OG002|Outcome|200mg SPN-812|Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
11260163|NCT02633527|OG003|Outcome|300mg SPN-812|Treatment D: 300mg SPN-812 was administered once daily and compared to placebo
11260164|NCT02633527|OG004|Outcome|400mg SPN-812|Treatment E: 400mg SPN-812 was administered once daily and compared to placebo
11260165|NCT02633527|EG000|Reported Event|Placebo|Treatment A: Placebo was administered once daily
11260166|NCT02633527|EG001|Reported Event|100mg SPN-812|Treatment B: 100mg SPN-812 was administered once daily and compared to placebo
11260167|NCT02633527|EG002|Reported Event|200mg SPN-812|Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
11260168|NCT02633527|EG003|Reported Event|300mg SPN-812|Treatment D: 300mg SPN-812 was administered once daily and compared to placebo
11260169|NCT02633527|EG004|Reported Event|400mg SPN-812|Treatment E: 400mg SPN-812 was administered once daily and compared to placebo
11260170|NCT02633735|BG000|Baseline|Control|Usual care
11260171|NCT02633735|BG001|Baseline|Intervention|"The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.~appy-cds: See description under arm/group section"
11260172|NCT02633735|BG002|Baseline|Total|Total of all reporting groups
11260173|NCT02633735|FG000|Participant Flow|Control|Usual care
11260174|NCT02633735|FG001|Participant Flow|Intervention|"The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.~appy-cds: See description under arm/group section"
11260175|NCT02633735|OG000|Outcome|Control|Usual care
11260176|NCT02633735|OG001|Outcome|Intervention|"The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.~appy-cds: See description under arm/group section"
11260177|NCT02633735|EG000|Reported Event|Appy CDS Intervention|"The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The Appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.~Post Appy Clinical Decision Support: The Appy CDS is a point of care clinical decision support system that provides the provider with 1) risk for appendicitis based on EHR data, 2) recommendations on actions to take based on risk, 3) advises on imaging use."
11260178|NCT02633735|EG001|Reported Event|Control|People in the control arm receive usual care.
11260179|NCT02633787|BG000|Baseline|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
11260180|NCT02633787|FG000|Participant Flow|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
11260181|NCT02633787|OG000|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
11260182|NCT02633787|EG000|Reported Event|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
11260183|NCT02633800|BG000|Baseline|Patritumab|All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260184|NCT02633800|BG001|Baseline|Placebo|All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260185|NCT02633800|BG002|Baseline|Total|Total of all reporting groups
11260186|NCT02633800|FG000|Participant Flow|Patritumab|All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260187|NCT02633800|FG001|Participant Flow|Placebo|All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260188|NCT02633800|OG000|Outcome|Patritumab|All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260189|NCT02633800|OG001|Outcome|Placebo|All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260190|NCT02633800|EG000|Reported Event|Patritumab|All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260191|NCT02633800|EG001|Reported Event|Placebo|All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
11260192|NCT02633956|BG000|Baseline|5 mg Obeticholic Acid|"5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260193|NCT02633956|BG001|Baseline|10 mg Obeticholic Acid|"10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260194|NCT02633956|BG002|Baseline|25 mg Obeticholic Acid|"25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260195|NCT02633956|BG003|Baseline|Placebo|"One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.~Placebo: Once a day (QD) by mouth (PO)"
11260196|NCT02633956|BG004|Baseline|Total|Total of all reporting groups
11260197|NCT02633956|FG000|Participant Flow|5 mg Obeticholic Acid|"5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260198|NCT02633956|FG001|Participant Flow|10 mg Obeticholic Acid|"10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260199|NCT02633956|FG002|Participant Flow|25 mg Obeticholic Acid|"25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260200|NCT02633956|FG003|Participant Flow|Placebo|"One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.~Placebo: Once a day (QD) by mouth (PO)"
11260201|NCT02633956|OG000|Outcome|5 mg Obeticholic Acid|"5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260202|NCT02633956|OG001|Outcome|10 mg Obeticholic Acid|"10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260203|NCT02633956|OG002|Outcome|25 mg Obeticholic Acid|"25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260204|NCT02633956|OG003|Outcome|Placebo|"One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.~Placebo: Once a day (QD) by mouth (PO)"
11260205|NCT02633956|OG000|Outcome|5 mg Obeticholic Acid|"5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260206|NCT02633956|OG001|Outcome|10 mg Obeticholic Acid|"10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260207|NCT02633956|OG002|Outcome|25 mg Obeticholic Acid|"25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260208|NCT02633956|OG003|Outcome|Placebo|"One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.~Placebo: Once a day (QD) by mouth (PO)"
11260209|NCT02633956|EG000|Reported Event|5 mg Obeticholic Acid|"5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11337441|NCT03585504|FG000|Participant Flow|Intervention Group|"Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11337442|NCT03585504|FG001|Participant Flow|Control Group|"These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11337443|NCT03585504|OG000|Outcome|Intervention Group|"Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11260210|NCT02633956|EG001|Reported Event|10 mg Obeticholic Acid|"10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260211|NCT02633956|EG002|Reported Event|25 mg Obeticholic Acid|"25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Obeticholic Acid: Once a day (QD) by mouth (PO)~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
11260212|NCT02633956|EG003|Reported Event|Placebo|"One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.~Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.~Placebo: Once a day (QD) by mouth (PO)"
11260213|NCT02634073|BG000|Baseline|All Treatment Groups Combined|Sixteen participants were randomized to receive one of the following 4 treatment sequences : Treatment sequence 1 : ABCD; Treatment sequence 2: DABC; Trearment sequence 3: BCDA; Treatment sequence 4: CDAB; where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g.
11260214|NCT02634073|FG000|Participant Flow|Treatment Sequence 1: ADBC|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
11260215|NCT02634073|FG001|Participant Flow|Treatment Sequence 2: BACD|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
11260216|NCT02634073|FG002|Participant Flow|Treatment Sequence 3: CBDA|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
11260217|NCT02634073|FG003|Participant Flow|Treatment Sequence 4: DCAB|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
11260218|NCT02634073|OG000|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260219|NCT02634073|OG001|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260220|NCT02634073|OG002|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260221|NCT02634073|OG003|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260222|NCT02634073|EG000|Reported Event|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260223|NCT02634073|EG001|Reported Event|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260224|NCT02634073|EG002|Reported Event|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260225|NCT02634073|EG003|Reported Event|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
11260226|NCT02634151|BG000|Baseline|Gemcabene 600 mg|Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
11260227|NCT02634151|BG001|Baseline|Placebo|Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
11260228|NCT02634151|BG002|Baseline|Total|Total of all reporting groups
11260229|NCT02634151|FG000|Participant Flow|Gemcabene 600 mg|Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
11260230|NCT02634151|FG001|Participant Flow|Placebo|Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
11260231|NCT02634151|OG000|Outcome|Gemcabene 600 mg|Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
11260232|NCT02634151|OG001|Outcome|Placebo|Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
11260233|NCT02634151|EG000|Reported Event|Gemcabene 600 mg|Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
11260234|NCT02634151|EG001|Reported Event|Placebo|Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
11260235|NCT02634177|BG000|Baseline|Assay-guided Treatment (AGT)|"Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.~Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability."
11260236|NCT02634177|BG001|Baseline|Treatment-as-usual (TAU)|"The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.~Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay."
11260237|NCT02634177|BG002|Baseline|Total|Total of all reporting groups
11260238|NCT02634177|FG000|Participant Flow|Assay-guided Treatment (AGT)|"Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.~Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability."
11260239|NCT02634177|FG001|Participant Flow|Treatment-as-usual (TAU)|"The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.~Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay."
11260240|NCT02634177|OG000|Outcome|Assay-guided Treatment (AGT)|"Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.~Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability."
11260241|NCT02634177|OG001|Outcome|Treatment-as-usual (TAU)|"The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.~Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay."
11260242|NCT02634177|EG000|Reported Event|Assay-guided Treatment (AGT)|"Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.~Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability."
11260243|NCT02634177|EG001|Reported Event|Treatment-as-usual (TAU)|"The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.~Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay."
11260244|NCT02634320|BG000|Baseline|Aripiprazole Lauroxil|"Intramuscular (IM) injection~Aripiprazole Lauroxil: Monthly IM injection"
11260245|NCT02634320|FG000|Participant Flow|Aripiprazole Lauroxil|"Intramuscular (IM) injection~Aripiprazole Lauroxil: Monthly IM injection"
11260246|NCT02634320|OG000|Outcome|Aripiprazole Lauroxil|"Intramuscular (IM) injection~Aripiprazole Lauroxil: Monthly IM injection"
11260247|NCT02634320|EG000|Reported Event|Aripiprazole Lauroxil|"Intramuscular (IM) injection~Aripiprazole Lauroxil: Monthly IM injection"
11260248|NCT02634333|BG000|Baseline|Aflibercept|"Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260249|NCT02634333|BG001|Baseline|Sham|"Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260250|NCT02634333|BG002|Baseline|Total|Total of all reporting groups
11286647|NCT02891200|OG000|Outcome|Healthcare Professional (HCP) Arm|"Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11260251|NCT02634333|FG000|Participant Flow|Aflibercept|"Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260252|NCT02634333|FG001|Participant Flow|Sham|"Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260253|NCT02634333|OG000|Outcome|Aflibercept|"Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260254|NCT02634333|OG001|Outcome|Sham|"Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260255|NCT02634333|EG000|Reported Event|Aflibercept|"Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260256|NCT02634333|EG001|Reported Event|Sham|"Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.~Prompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.~Deferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met~Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria."
11260257|NCT02634333|EG002|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
11260258|NCT02634346|BG000|Baseline|ALKS 3831|"Administered as a coated bilayer tablet~ALK3831: Daily dosing"
11260259|NCT02634346|BG001|Baseline|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11260260|NCT02634346|BG002|Baseline|Placebo|"Administered as a coated bilayer tablet~Placebo: Daily dosing"
11260261|NCT02634346|BG003|Baseline|Total|Total of all reporting groups
11260262|NCT02634346|FG000|Participant Flow|ALKS 3831|"Olanzapine + samidorphan; administered as a coated bilayer tablet~ALK3831: Daily dosing"
11260263|NCT02634346|FG001|Participant Flow|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11260264|NCT02634346|FG002|Participant Flow|Placebo|"Administered as a coated bilayer tablet~Placebo: Daily dosing"
11260265|NCT02634346|OG000|Outcome|ALKS 3831|"Administered as a coated bilayer tablet~ALK3831: Daily dosing"
11260266|NCT02634346|OG001|Outcome|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11260267|NCT02634346|OG002|Outcome|Placebo|"Administered as a coated bilayer tablet~Placebo: Daily dosing"
11260268|NCT02634346|EG000|Reported Event|ALKS 3831|"Administered as a coated bilayer tablet~ALK3831: Daily dosing"
11260269|NCT02634346|EG001|Reported Event|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11260270|NCT02634346|EG002|Reported Event|Placebo|"Administered as a coated bilayer tablet~Placebo: Daily dosing"
11260271|NCT02634580|BG000|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11260272|NCT02634580|BG001|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks.
11260273|NCT02634580|BG002|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks.
11260274|NCT02634580|BG003|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks.
11260275|NCT02634580|BG004|Baseline|Total|Total of all reporting groups
11260276|NCT02634580|FG000|Participant Flow|Ezetimibe (Q2W)|"Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks in the double-blind treatment period.~From week 12 to week 48 participants self-administered 140 mg evolocumab subcutaneously every 2 weeks in the open-label extension period."
11260277|NCT02634580|FG001|Participant Flow|Ezetimibe (QM)|"Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks in the double-blind treatment period.~From week 12 to week 48 participants self-administered 420 mg evolocumab subcutaneously once a month in the open-label extension period."
11260278|NCT02634580|FG002|Participant Flow|Evolocumab Q2W|"Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks in the double-blind treatment period.~From week 12 to week 48 participants self-administered 140 mg evolocumab subcutaneously every 2 weeks in the open-label extension period."
11260279|NCT02634580|FG003|Participant Flow|Evolocumab QM|"Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks in the double-blind treatment period.~From week 12 to week 48 participants self-administered 420 mg evolocumab subcutaneously once a month in the open-label extension period."
11260280|NCT02634580|OG000|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
11260281|NCT02634580|OG001|Outcome|Evolocumab|Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
11260282|NCT02634580|EG000|Reported Event|DB Period: Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
11260283|NCT02634580|EG001|Reported Event|DB Period: Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks.
11260284|NCT02634580|EG002|Reported Event|DB Period: Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks.
11260285|NCT02634580|EG003|Reported Event|DB Period: Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks.
11260286|NCT02634580|EG004|Reported Event|OLE Period: Evolocumab|Participants received evolocumab by subcutaneous injection from week 12 to week 48 at the same dosing interval as the investigational product regimen that they were randomized to during the double-blind period (ie, every 2 weeks or once monthly) during the open-label extension (OLE) period.
11260287|NCT02634684|BG000|Baseline|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11286648|NCT02891200|OG001|Outcome|HCP Plus Peer Arm|"HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker.~Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11286649|NCT02891200|EG000|Reported Event|Healthcare Professional (HCP) Arm|"Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11260288|NCT02634684|BG001|Baseline|Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260289|NCT02634684|BG002|Baseline|Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260290|NCT02634684|BG003|Baseline|Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260291|NCT02634684|BG004|Baseline|Total|Total of all reporting groups
11260292|NCT02634684|FG000|Participant Flow|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine.~Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11286650|NCT02891200|EG001|Reported Event|HCP Plus Peer Arm|"HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker.~Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.~HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials ."
11286651|NCT02891408|BG000|Baseline|Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg|Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286652|NCT02891408|BG001|Baseline|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286653|NCT02891408|BG002|Baseline|Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
11260293|NCT02634684|FG001|Participant Flow|Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine.~Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260294|NCT02634684|FG002|Participant Flow|Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine.~Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260295|NCT02634684|FG003|Participant Flow|Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine.~Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260296|NCT02634684|OG000|Outcome|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260297|NCT02634684|OG001|Outcome|Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260298|NCT02634684|OG002|Outcome|Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260299|NCT02634684|OG003|Outcome|Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo|"Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes ~6 hours of testing in the laboratory. The participant stays at the lab for ~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week.~Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.~Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week."
11260300|NCT02634684|EG000|Reported Event|Subjects With Schizophrenia: Placebo|Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11260301|NCT02634684|EG001|Reported Event|Subjects With Schizophrenia: 10 mg Amphetamine|Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11260302|NCT02634684|EG002|Reported Event|Healthy Subjects: Placebo|Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11260303|NCT02634684|EG003|Reported Event|Healthy Subjects: 10 mg Amphetamine|Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11260304|NCT02634788|BG000|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
11260305|NCT02634788|BG001|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
11260306|NCT02634788|BG002|Baseline|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
11260307|NCT02634788|BG003|Baseline|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
11260308|NCT02634788|BG004|Baseline|Total|Total of all reporting groups
11260309|NCT02634788|FG000|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
11260310|NCT02634788|FG001|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
11260311|NCT02634788|FG002|Participant Flow|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
11260312|NCT02634788|FG003|Participant Flow|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
11260313|NCT02634788|OG000|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
11260314|NCT02634788|OG001|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
11260315|NCT02634788|OG002|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
11260316|NCT02634788|OG003|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
11260317|NCT02634788|EG000|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
11260318|NCT02634788|EG001|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
11260319|NCT02634788|EG002|Reported Event|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
11260320|NCT02634788|EG003|Reported Event|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
11260321|NCT02634801|BG000|Baseline|Ixekizumab|"160 mg ixekizumab given as two SC injection followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.~Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks."
11260322|NCT02634801|BG001|Baseline|Fumaric Acid Esters|"Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260323|NCT02634801|BG002|Baseline|Methotrexate|"7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260324|NCT02634801|BG003|Baseline|Total|Total of all reporting groups
11260325|NCT02634801|FG000|Participant Flow|Ixekizumab|"160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.~Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks."
11260326|NCT02634801|FG001|Participant Flow|Fumaric Acid Esters|"Starting dose of 105 mg Fumaric Acid Esters (FAE) given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260327|NCT02634801|FG002|Participant Flow|Methotrexate|"7.5 mg starting dose up to 30 mg Methotrexate (MTX) given orally once a week until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260328|NCT02634801|OG000|Outcome|Ixekizumab|"160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.~Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks."
11260329|NCT02634801|OG001|Outcome|Fumaric Acid Esters|"Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260330|NCT02634801|OG002|Outcome|Methotrexate|"7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260331|NCT02634801|EG000|Reported Event|Ixekizumab-Treatment Period|"160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.~Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks."
11260332|NCT02634801|EG001|Reported Event|Fumaric Acid Esters-Treatment Period|"Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260333|NCT02634801|EG002|Reported Event|Methotrexate-Treatment Period|7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
11260334|NCT02634801|EG003|Reported Event|Ixekizumab-Extension Period|"160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.~Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks."
11260335|NCT02634801|EG004|Reported Event|Fumaric Acid Esters-Extension Period|"Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.~Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks."
11260336|NCT02634801|EG005|Reported Event|Methotrexate-Extension Period|7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
11260337|NCT02634801|EG006|Reported Event|Follow-up Period|Participants were allowed to continue the treatment administered during the treatment and extension period.
11260338|NCT02634814|BG000|Baseline|TENS and Therapeutic Exercise|Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
11260339|NCT02634814|BG001|Baseline|Sham TENS and Therapeutic Exercise|"Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program."
11260340|NCT02634814|BG002|Baseline|Therapeutic Exercise Only|Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
11260341|NCT02634814|BG003|Baseline|Total|Total of all reporting groups
11260342|NCT02634814|FG000|Participant Flow|TENS and Therapeutic Exercise|Patients assigned to this group will receive a Select System TENS (i.e., transcutaneous electrical nerve stimulation TENS) unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
11286654|NCT02891408|BG003|Baseline|Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg|Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11260343|NCT02634814|FG001|Participant Flow|Sham TENS and Therapeutic Exercise|"Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of traditional therapeutic exercise (TE) will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program."
11260344|NCT02634814|FG002|Participant Flow|Therapeutic Exercise Only|Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
11260345|NCT02634814|OG000|Outcome|TENS and Therapeutic Exercise|Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
11260346|NCT02634814|OG001|Outcome|Sham TENS and Therapeutic Exercise|"Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program."
11260347|NCT02634814|OG002|Outcome|Therapeutic Exercise Only|Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
11260348|NCT02634814|EG000|Reported Event|TENS and Therapeutic Exercise|Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
11260349|NCT02634814|EG001|Reported Event|Sham TENS and Therapeutic Exercise|"Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program."
11260350|NCT02634814|EG002|Reported Event|Therapeutic Exercise Only|Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
11260351|NCT02634983|BG000|Baseline|All Study Participants|Participants who were randomized to receive either QVA149 110/50 mcg or Placebo matching QVA149 110/50 mcg
11260352|NCT02634983|FG000|Participant Flow|QVA149 110/50 mcg Then Matching Placebo|QVA149, followed by matching placebo. Each treatment 8-10 days.
11260353|NCT02634983|FG001|Participant Flow|Matching Placebo Then QVA149 110/50 mcg|Matching placebo, followed by QVA149. Each treatment 8-10 days.
11260354|NCT02634983|OG000|Outcome|QVA149 110/50 mcg|Single daily dose of 110/50 μg QVA149 for 8-10 days.
11260355|NCT02634983|OG001|Outcome|Matching Placebo|Single daily dose of matching placebo for 8-10 days.
11260356|NCT02634983|EG000|Reported Event|QVA149 110/50 mcg|Single daily dose of 110/50 μg QVA149 for 8-10 days.
11260357|NCT02634983|EG001|Reported Event|Matching Placebo|Single daily dose of matching placebo for 8-10 days.
11260358|NCT02635035|BG000|Baseline|Lisdexamfetamine First|"In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260359|NCT02635035|BG001|Baseline|Lisdexamfetamine Second|"In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260360|NCT02635035|BG002|Baseline|Total|Total of all reporting groups
11260361|NCT02635035|FG000|Participant Flow|Lisdexamfetamine First|"In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11286655|NCT02891408|BG004|Baseline|Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg|Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11260362|NCT02635035|FG001|Participant Flow|Lisdexamfetamine Second|"In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260363|NCT02635035|OG000|Outcome|Lisdexamfetamine First|"In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260364|NCT02635035|OG001|Outcome|Lisdexamfetamine Second|"In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260365|NCT02635035|EG000|Reported Event|Lisdexamfetamine First|"In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260366|NCT02635035|EG001|Reported Event|Lisdexamfetamine Second|"In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second~Lisdexamfetamine: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.~Placebo: Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill."
11260367|NCT02635204|BG000|Baseline|DFD-06 Cream|Participants applied DFD-06 Cream twice daily for 14 days.
11260368|NCT02635204|BG001|Baseline|Vehicle Cream|Participants received Vehicle Cream and was applied twice daily for 14 days.
11260369|NCT02635204|BG002|Baseline|Total|Total of all reporting groups
11260370|NCT02635204|FG000|Participant Flow|DFD-06 Cream|DFD-06 Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
11260371|NCT02635204|FG001|Participant Flow|Vehicle Cream|Vehicle Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
11260372|NCT02635204|OG000|Outcome|DFD-06 Cream|Participants received DFD-06 Cream applied topical twice daily for 14 days.
11260373|NCT02635204|OG001|Outcome|Vehicle Cream|Participants received Vehicle Cream applied topical twice daily for 14 days.
11260374|NCT02635204|EG000|Reported Event|DFD-06 Cream|DFD-06 Cream applied to subjects twice daily for 14 days.
11260375|NCT02635204|EG001|Reported Event|Vehicle Cream|Vehicle Cream applied to subjects twice daily for 14 days.
11260376|NCT02635347|BG000|Baseline|Remote Ischemic Conditioning (RIC) Cohort|Subjects received remote ischemic conditioning
11260377|NCT02635347|BG001|Baseline|Historical Control Cohort|Historical control subjects received liver transplants in an earlier period
11260378|NCT02635347|BG002|Baseline|Total|Total of all reporting groups
11260379|NCT02635347|FG000|Participant Flow|Remote Ischemic Conditioning (RIC) Group|"Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC~Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.~Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions."
11260380|NCT02635347|FG001|Participant Flow|Historical Control Cohort|Matched historical controls
11260381|NCT02635347|OG000|Outcome|Remote Ischemic Conditioning (RIC) Group|"Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC~Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.~Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions."
11260382|NCT02635347|OG001|Outcome|Historical Control Cohort|Subjects in this cohort were chosen via retrospective record review, and selected applying the same inclusion and exclusion criteria as in the RIC cohort. They were chosen consecutively in revere-chronological order that began at the start of the study date. Target ratio of RIC:Controls was 1:2. No matching was performed for age, sex, and model for end stage liver disease (MELD) score.
11260383|NCT02635347|OG001|Outcome|Historical Control Cohort|Historical matched recipient controls
11260384|NCT02635347|EG000|Reported Event|Remote Ischemic Conditioning (RIC) Group|"Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC~Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.~Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions."
11260385|NCT02635347|EG001|Reported Event|Historical Control Cohort|Subjects in this cohort were chosen via retrospective record review, and selected applying the same inclusion and exclusion criteria as in the RIC cohort. They were chosen consecutively in revere-chronological order that began at the start of the study date. Target ratio of RIC:Controls was 1:2. No matching was performed for age, sex, and model for end stage liver disease (MELD) score.
11260386|NCT02635386|BG000|Baseline|Exenatide Once Weekly (EQW )|"EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks~Exenatide once weekly (EQW ): 2 mg SC injection every 7 days"
11260387|NCT02635386|BG001|Baseline|Dapagliflozin (DAPA)|"DAPA-10 mg oral pill once daily in am for 24 weeks~Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am"
11260388|NCT02635386|BG002|Baseline|EQW Plus DAPA|"EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks~EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am"
11260389|NCT02635386|BG003|Baseline|Dapagliflozin Plus Glucophage (MET ER)|"Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks~Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose"
11260390|NCT02635386|BG004|Baseline|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260391|NCT02635386|BG005|Baseline|Total|Total of all reporting groups
11260392|NCT02635386|FG000|Participant Flow|Exenatide Once Weekly (EQW )|"EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks~Exenatide once weekly (EQW ): 2 mg SC injection every 7 days"
11260393|NCT02635386|FG001|Participant Flow|Dapagliflozin (DAPA)|"DAPA-10 mg oral pill once daily in am for 24 weeks~Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am"
11260394|NCT02635386|FG002|Participant Flow|EQW Plus DAPA|"EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks~EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am"
11260395|NCT02635386|FG003|Participant Flow|Dapagliflozin Plus Glucophage (MET ER)|"Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks~Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose"
11260396|NCT02635386|FG004|Participant Flow|Phentermine /Topiramate (PHEN/ TRP) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TRP) ER: PHEN 3.75/TRP ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TRP ER 46mg- 1 pill by mouth once daily in am"
11260397|NCT02635386|OG000|Outcome|Exenatide Once Weekly (EQW )|"EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks~Exenatide once weekly (EQW ): 2 mg SC injection every 7 days"
11260398|NCT02635386|OG001|Outcome|Dapagliflozin (DAPA)|"DAPA-10 mg oral pill once daily in am for 24 weeks~Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am"
11260399|NCT02635386|OG002|Outcome|EQW Plus DAPA|"EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks~EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am"
11260400|NCT02635386|OG003|Outcome|Dapagliflozin Plus Glucophage (MET ER)|"Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks~Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose"
11260401|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260402|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPMER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260403|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPMER 46mg- 1 pill by mouth once daily in am"
11260404|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260405|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260406|NCT02635386|OG004|Outcome|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260407|NCT02635386|EG000|Reported Event|Exenatide Once Weekly (EQW )|"EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks~Exenatide once weekly (EQW ): 2 mg SC injection every 7 days"
11260408|NCT02635386|EG001|Reported Event|Dapagliflozin (DAPA)|"DAPA-10 mg oral pill once daily in am for 24 weeks~Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am"
11260409|NCT02635386|EG002|Reported Event|EQW Plus DAPA|"EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks~EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am"
11260410|NCT02635386|EG003|Reported Event|Dapagliflozin Plus Glucophage (MET ER)|"Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks~Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose"
11260411|NCT02635386|EG004|Reported Event|Phentermine /Topiramate (PHEN/ TPM) ER|"Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks~Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am"
11260412|NCT02635425|BG000|Baseline|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
11260413|NCT02635425|BG001|Baseline|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
11260414|NCT02635425|BG002|Baseline|Total|Total of all reporting groups
11260415|NCT02635425|FG000|Participant Flow|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
11260416|NCT02635425|FG001|Participant Flow|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
11260417|NCT02635425|OG000|Outcome|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
11260418|NCT02635425|OG001|Outcome|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
11260419|NCT02635425|EG000|Reported Event|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
11260420|NCT02635425|EG001|Reported Event|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
11260421|NCT02635542|BG000|Baseline|Group CIS|"Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).~Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia."
11260422|NCT02635542|BG001|Baseline|Group SUX|"A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.~Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia."
11260423|NCT02635542|BG002|Baseline|Total|Total of all reporting groups
11260424|NCT02635542|FG000|Participant Flow|Group CIS|"Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).~Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia."
11260425|NCT02635542|FG001|Participant Flow|Group SUX|"A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.~Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia."
11260426|NCT02635542|OG000|Outcome|Group CIS|"Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).~Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia."
11260427|NCT02635542|OG001|Outcome|Group SUX|"A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.~Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia."
11260428|NCT02635542|EG000|Reported Event|Group CIS|"Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).~Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia."
11260429|NCT02635542|EG001|Reported Event|Group SUX|"A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.~Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia."
11260430|NCT02635646|BG000|Baseline|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling."
11260431|NCT02635646|BG001|Baseline|Individual Approach|"Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~Individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually."
11260432|NCT02635646|BG002|Baseline|Total|Total of all reporting groups
11260433|NCT02635646|FG000|Participant Flow|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~56 patients were included in this group"
11260434|NCT02635646|FG001|Participant Flow|Individual Approach|"Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~Individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~58 patients were included in this group"
11260435|NCT02635646|OG000|Outcome|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~57 patients were included in this group"
11260436|NCT02635646|OG001|Outcome|Individual Approach|"individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~65 patients were included in this group"
11260437|NCT02635646|OG000|Outcome|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~57 patients started in this group, but only 32 completed the 12-month follow-up"
11260438|NCT02635646|OG001|Outcome|Individual Approach|"individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~65 patients started in this group, but only 39 completed the 12-month follow-up"
11260439|NCT02635646|OG000|Outcome|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~68 patients were included in this group, but only 23 completed the 12-month follow-up"
11260440|NCT02635646|OG001|Outcome|Individual Approach|"Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~Individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~33 patients were included in this group, but only 7 completed the 12-month follow-up"
11260441|NCT02635646|OG000|Outcome|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~57 patients were included in this group, but only 32 patients completed the 12-month follow-up"
11260442|NCT02635646|OG001|Outcome|Individual Approach|"individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~65 patients were included in this group, but only 39 patients completed the 12-month follow-up"
11286656|NCT02891408|BG005|Baseline|Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg|Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11260443|NCT02635646|EG000|Reported Event|Family and Interdisciplinary Approach|"Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months~Family and interdisciplinary approach: Family and interdisciplinary approach that includes:~nutritional counseling,~physical activity counseling,~psychological counseling,~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.~56 patients were included in this group"
11260444|NCT02635646|EG001|Reported Event|Individual Approach|"Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months~Individual approach: Individual approach that includes:~nutritional and physical activity counseling in individual appointments,~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.~58 patients were included in this group"
11260445|NCT02635724|BG000|Baseline|At Risk (<65 Years)|A single IV dose of peramivir was administered to adults considered at risk
11260446|NCT02635724|BG001|Baseline|Elderly (65-75 Years)|A single IV dose of peramivir was administered to adults aged 65 to 75 years
11260447|NCT02635724|BG002|Baseline|Very Elderly (>75 Years)|A single IV dose of peramivir was administered to adults aged over 75 years
11260448|NCT02635724|BG003|Baseline|Total|Total of all reporting groups
11260449|NCT02635724|FG000|Participant Flow|At Risk (<65 Years)|A single IV dose of peramivir was administered to adults considered at risk, including pregnant women, residents of long-term care facilities, American Indians and Alaskan Natives, as well as those with comorbidities (e.g. asthma, heart disease, diabetes) that increased the risk of complications.
11260450|NCT02635724|FG001|Participant Flow|Elderly (65-75 Years)|A single IV dose of peramivir was administered to adults aged 65 to 75 years
11260451|NCT02635724|FG002|Participant Flow|Very Elderly (>75 Years)|A single IV dose of peramivir was administered to adults aged over 75 years
11260452|NCT02635724|OG000|Outcome|At Risk (<65 Years)|A single IV dose of peramivir was administered to adults considered at risk
11260453|NCT02635724|OG001|Outcome|Elderly (65-75 Years)|A single IV dose of peramivir was administered to adults aged 65 to 75 years
11260454|NCT02635724|OG002|Outcome|Very Elderly (>75 Years)|A single IV dose of peramivir was administered to adults aged over 75 years
11260455|NCT02635724|EG000|Reported Event|At Risk (<65 Years)|A single IV dose of peramivir was administered to adults considered at risk
11260456|NCT02635724|EG001|Reported Event|Elderly (65-75 Years)|A single IV dose of peramivir was administered to adults aged 65 to 75 years
11260457|NCT02635724|EG002|Reported Event|Very Elderly (>75 Years)|A single IV dose of peramivir was administered to adults aged over 75 years
11260458|NCT02635737|BG000|Baseline|Sentimark Device Placement|"Sentimark device placed in women having mastectomy surgery~Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation"
11260459|NCT02635737|FG000|Participant Flow|Sentimark Device Placement|"Sentimark device placed in women having mastectomy surgery~Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation"
11260460|NCT02635737|OG000|Outcome|Sentimark Device Placement|"Sentimark device placed in women having mastectomy surgery~Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation"
11260461|NCT02635737|EG000|Reported Event|Sentimark Device Placement|"Sentimark device placed in women having mastectomy surgery~Sentimark: Placement of a metallic clip with paramagnetic properties for tumour localisation"
11260462|NCT02635828|BG000|Baseline|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
11260463|NCT02635828|FG000|Participant Flow|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
11260464|NCT02635828|OG000|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
11260465|NCT02635828|EG000|Reported Event|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
11260466|NCT02635880|BG000|Baseline|Baseline Group|The following types of benign pigmented lesions will be treated in this study: (1) lentigines (solar or senile); (2) ephelides (freckles); and (3) seborrheic keratosis.
11260467|NCT02635880|FG000|Participant Flow|Healty Evaluation of Clinical Study|Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
11260468|NCT02635880|OG000|Outcome|Investigational Enlighten Device|Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
11260469|NCT02635880|EG000|Reported Event|Investigational Enlighten Device|"Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.~Investigational Enlighten Device: Up to 3 laser treatments, spaced 4 to 6 weeks apart"
11260470|NCT02635984|BG000|Baseline|Triplet Therapy Plus Placebo|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.~Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy"
11260471|NCT02635984|BG001|Baseline|Triplet Therapy Plus Olanzapine|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.~Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy"
11260472|NCT02635984|BG002|Baseline|Total|Total of all reporting groups
11260473|NCT02635984|FG000|Participant Flow|Triplet Therapy Plus Placebo|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.~Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy"
11260474|NCT02635984|FG001|Participant Flow|Triplet Therapy Plus Olanzapine|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.~Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy"
11260475|NCT02635984|OG000|Outcome|Triplet Therapy Plus Placebo|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.~Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy"
11260476|NCT02635984|OG001|Outcome|Triplet Therapy Plus Olanzapine|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.~Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy"
11260477|NCT02635984|EG000|Reported Event|Triplet Therapy Plus Placebo|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.~Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy"
11260478|NCT02635984|EG001|Reported Event|Triplet Therapy Plus Olanzapine|"All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.~Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy"
11260479|NCT02636049|BG000|Baseline|Safety Population|All 12 participants completed every arm of the study. Therefore, the baseline demographic characteristics of the Safety Population as a whole also reflect the characteristics of each arm of the study.
11260480|NCT02636049|FG000|Participant Flow|All Participants|"After enrollment, all subjects underwent blood sampling for pharmacokinetic (PK) purposes over 16 hours on Day 1 to establish a baseline. On Day 2, subjects received a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours, with blood sampling for PK purposes over 16 hours. On Day 3, subject received Triferic 35 micrograms/kg as an intravenous push (administered in 30 - 60 seconds), with blood sampling for PK purposes over 16 hours.~Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron."
11260481|NCT02636049|OG000|Outcome|Treatment Period: 6 mg Triferic IV Over 3 Hours|"Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron.~Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron."
11260482|NCT02636049|OG001|Outcome|Treatment Period: 35 Micrograms/kg IV Push|"Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL.~Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron."
11260483|NCT02636049|EG000|Reported Event|Treatment Period: 6 mg Triferic IV Over 3 Hours|"Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron.~Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron."
11286657|NCT02891408|BG006|Baseline|Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11286658|NCT02891408|BG007|Baseline|Total|Total of all reporting groups
11260484|NCT02636049|EG001|Reported Event|Treatment Period: 35 Micrograms/kg IV Push|"Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL.~Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron."
11260485|NCT02636361|BG000|Baseline|Overall Study|All participants who received at least 1 dose of study drug.
11260486|NCT02636361|FG000|Participant Flow|Sequence 1 BDCAR|B = LY900014 Test B, D, LY900014 Test D, C = LY900014 Test C, A = LY900014 Test A, R = Reference, insulin lispro (Humalog)
11260487|NCT02636361|FG001|Participant Flow|Sequence 2 ADCRB|A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, R = Reference, insulin lispro (Humalog), B = LY900014 Test B
11260488|NCT02636361|FG002|Participant Flow|Sequence 3 ADRCB|A = LY900014 Test A, D=LY900014 Test D,R = Reference, insulin lispro (Humalog), C = LY900014 Test C, B = LY900014 Test B
11260489|NCT02636361|FG003|Participant Flow|Sequence 4 BRDAC|B = LY900014 Test B,R = Reference, insulin lispro (Humalog),D=LY900014 Test D, A = LY900014 Test A,C = LY900014 Test C
11260490|NCT02636361|FG004|Participant Flow|Sequence 5 RADCB|R = Reference, insulin lispro (Humalog)A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, B = LY900014 Test B
11260491|NCT02636361|OG000|Outcome|LY900014 Test A|LY900014 Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
11260492|NCT02636361|OG001|Outcome|LY900014 Test B|LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
11260493|NCT02636361|OG002|Outcome|LY900014 Test C|LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
11260494|NCT02636361|OG003|Outcome|LY900014 Test D|LY900014 Test Formulation D. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
11260495|NCT02636361|OG004|Outcome|Reference (Insulin Lispro, Humalog)|A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods
11260496|NCT02636361|OG000|Outcome|LY900014 Test A|LY900014 Test Formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods.
11260497|NCT02636361|OG003|Outcome|LY900014 Test D|LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
11260498|NCT02636361|EG000|Reported Event|Reference (Insulin Lispro, Humalog)|Reference formulation: Single dose of lispro administered SC in one of five periods
11260499|NCT02636361|EG001|Reported Event|LY900014 Test A|Test formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
11260500|NCT02636361|EG002|Reported Event|LY900014 Test B|Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
11260501|NCT02636361|EG003|Reported Event|LY900014 Test C|Test formulation C: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
11260502|NCT02636361|EG004|Reported Event|LY900014 Test D|Test formulation D: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
11260503|NCT02636595|BG000|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260504|NCT02636595|FG000|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260505|NCT02636595|OG000|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260506|NCT02636595|EG000|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260507|NCT02636608|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11260508|NCT02636608|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11260509|NCT02636608|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11260510|NCT02636608|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 or 24 weeks.
11260511|NCT02636608|OG001|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11260512|NCT02636608|EG000|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for12 or 24 weeks.
11260513|NCT02636608|EG001|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11260514|NCT02636699|BG000|Baseline|DBV712 250 μg|Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260515|NCT02636699|BG001|Baseline|Placebo|Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260516|NCT02636699|BG002|Baseline|Total|Total of all reporting groups
11260517|NCT02636699|FG000|Participant Flow|DBV712 250 μg|Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260518|NCT02636699|FG001|Participant Flow|Placebo|Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260519|NCT02636699|OG000|Outcome|DBV712 250 μg|Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260520|NCT02636699|OG001|Outcome|Placebo|Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260521|NCT02636699|EG000|Reported Event|DBV712 250 μg|Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260522|NCT02636699|EG001|Reported Event|Placebo|Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
11260523|NCT02636712|BG000|Baseline|ImageReady™ System Indication|"Subject must have the ImageReady™ System as their initial (de novo) pacing system implant~Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines~ImageReady™ MR Conditional Pacing System"
11260524|NCT02636712|FG000|Participant Flow|ImageReady™ System Indication|"Subject must have the ImageReady™ System as their initial (de novo) pacing system implant~Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines~ImageReady™ MR Conditional Pacing System"
11260525|NCT02636712|OG000|Outcome|ImageReady™ MR System Indication|"Subject must have the ImageReady™ System as their initial (de novo) pacing system implant~Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines~ImageReady™ MR Conditional Pacing System"
11260526|NCT02636712|OG000|Outcome|ImageReady™ System Indication|"Subject must have the ImageReady™ System as their initial (de novo) pacing system implant~Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines~ImageReady™ MR Conditional Pacing System"
11260527|NCT02636712|EG000|Reported Event|ImageReady™ MR Conditional Pacing System|"Subject must have the ImageReady™ System as their initial (de novo) pacing system implant~Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines~ImageReady™ MR Conditional Pacing System"
11260528|NCT02636725|BG000|Baseline|Axitinib Plus Pembrolizumab Group|"Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first."
11260529|NCT02636725|FG000|Participant Flow|Axitinib Plus Pembrolizumab Group|"Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first."
11260530|NCT02636725|OG000|Outcome|Axitinib Plus Pembrolizumab Group|"Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first."
11286659|NCT02891408|FG000|Participant Flow|Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg|Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11260531|NCT02636725|EG000|Reported Event|Axitinib Plus Pembrolizumab Group|"Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.~Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first."
11260532|NCT02636868|BG000|Baseline|Aerosolized Lucinactant (40 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260533|NCT02636868|BG001|Baseline|Aerosolized Lucinactant (80 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260534|NCT02636868|BG002|Baseline|nCPAP Only|"nCPAP alone~nCPAP: Nasal CPAP"
11260535|NCT02636868|BG003|Baseline|Total|Total of all reporting groups
11260536|NCT02636868|FG000|Participant Flow|Aerosolized Lucinactant (40 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260537|NCT02636868|FG001|Participant Flow|Aerosolized Lucinactant (80 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260538|NCT02636868|FG002|Participant Flow|nCPAP Only|"nCPAP alone~nCPAP: Nasal CPAP"
11260539|NCT02636868|OG000|Outcome|Aerosolized Lucinactant (40 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260540|NCT02636868|OG001|Outcome|Aerosolized Lucinactant (80 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260541|NCT02636868|OG002|Outcome|nCPAP Only|"nCPAP alone~nCPAP: Nasal CPAP"
11260542|NCT02636868|EG000|Reported Event|Aerosolized Lucinactant (40 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260543|NCT02636868|EG001|Reported Event|Aerosolized Lucinactant (80 mg TPL/kg)|"Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.~Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)~nCPAP: Nasal CPAP"
11260544|NCT02636868|EG002|Reported Event|nCPAP Only|"nCPAP alone~nCPAP: Nasal CPAP"
11260545|NCT02636907|BG000|Baseline|BI 695501|Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
11260546|NCT02636907|FG000|Participant Flow|BI 695501|Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
11260547|NCT02636907|OG000|Outcome|BI 695501|Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
11260548|NCT02636907|EG000|Reported Event|BI 695501|Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections
11260549|NCT02637037|BG000|Baseline|Part 1|Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg)
11260550|NCT02637037|BG001|Baseline|Part 2|Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg)
11260551|NCT02637037|BG002|Baseline|Total|Total of all reporting groups
11260552|NCT02637037|FG000|Participant Flow|Part 1|Sequences 1, 2, 3 and 4- each sequence had 10 subjects; Part 1: ABCD, BADC, ABDC, BACD (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted) Part 1: Test: Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant (1 x 5/500 mg); Reference: Dapagliflozin/metformin XR mg manufactured at Humacao plant (1 x 5/500 mg)
11260553|NCT02637037|FG001|Participant Flow|Part 2|Sequences 1, 2, 3 and 4 - each sequence had 10 subjects Part 2: EFGH, FEHG, EFHG, FEGH (E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) Part 2: Test: Dapagliflozin/metformin XR manufactured at Mount Vernon plant (1 x 10/1000 mg); Reference: Dapagliflozin/metformin XR manufactured at Humacao plant (1 x 10/1000 mg)
11260554|NCT02637037|OG000|Outcome|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
11260555|NCT02637037|OG001|Outcome|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
11260556|NCT02637037|OG002|Outcome|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260557|NCT02637037|OG003|Outcome|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260558|NCT02637037|OG004|Outcome|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260559|NCT02637037|OG005|Outcome|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260560|NCT02637037|OG006|Outcome|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260561|NCT02637037|OG007|Outcome|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260562|NCT02637037|EG000|Reported Event|Treatment A|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Mount Vernon plant
11260563|NCT02637037|EG001|Reported Event|Treatment B|Fed - 5/500 mg - Dapagliflozin/metformin XR mg manufactured at Humacao plant
11260564|NCT02637037|EG002|Reported Event|Treatment C|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260565|NCT02637037|EG003|Reported Event|Treatment D|Fasted - 5/500 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260566|NCT02637037|EG004|Reported Event|Treatment E|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260567|NCT02637037|EG005|Reported Event|Treatment F|Fed - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260568|NCT02637037|EG006|Reported Event|Treatment G|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Mount Vernon plant
11260569|NCT02637037|EG007|Reported Event|Treatment H|Fasted - 10/1000 mg - Dapagliflozin/metformin XR manufactured at Humacao plant
11260570|NCT02637063|BG000|Baseline|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260571|NCT02637063|BG001|Baseline|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260572|NCT02637063|BG002|Baseline|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
11260573|NCT02637063|BG003|Baseline|Total|Total of all reporting groups
11260574|NCT02637063|FG000|Participant Flow|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260575|NCT02637063|FG001|Participant Flow|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260576|NCT02637063|FG002|Participant Flow|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
11260577|NCT02637063|OG000|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260578|NCT02637063|OG001|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260579|NCT02637063|OG002|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
11260580|NCT02637063|EG000|Reported Event|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260581|NCT02637063|EG001|Reported Event|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
11260582|NCT02637063|EG002|Reported Event|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
11260583|NCT02637076|BG000|Baseline|Narcolepsy With Cataplexy|"patients given single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260584|NCT02637076|BG001|Baseline|Healthy Controls|"healthy controls given a single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260585|NCT02637076|BG002|Baseline|Total|Total of all reporting groups
11260586|NCT02637076|FG000|Participant Flow|Narcolepsy With Cataplexy|"patients given single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260587|NCT02637076|FG001|Participant Flow|Healthy Controls|"healthy controls given a single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260588|NCT02637076|OG000|Outcome|Narcolepsy With Cataplexy|"patients given single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260589|NCT02637076|OG001|Outcome|Healthy Controls|"healthy controls given a single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260590|NCT02637076|EG000|Reported Event|Narcolepsy With Cataplexy|"patients given single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260591|NCT02637076|EG001|Reported Event|Healthy Controls|"healthy controls given a single dose of Xyrem~Xyrem: single 3.0 gram dose"
11260592|NCT02637141|BG000|Baseline|AMG 714 150 mg|Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260593|NCT02637141|BG001|Baseline|AMG 714 300 mg|Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260594|NCT02637141|BG002|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260595|NCT02637141|BG003|Baseline|Total|Total of all reporting groups
11260596|NCT02637141|FG000|Participant Flow|AMG 714 150 mg|Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260597|NCT02637141|FG001|Participant Flow|AMG 714 300 mg|Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260598|NCT02637141|FG002|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260599|NCT02637141|OG000|Outcome|AMG 714 150 mg|Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260600|NCT02637141|OG001|Outcome|AMG 714 300 mg|Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260601|NCT02637141|OG002|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260602|NCT02637141|EG000|Reported Event|150 mg AMG 714|Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260603|NCT02637141|EG001|Reported Event|300 mg AMG 714|Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260604|NCT02637141|EG002|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
11260605|NCT02637232|BG000|Baseline|Mirvaso® / Onreltea TM|Mirvaso® / Onreltea TM
11260606|NCT02637232|FG000|Participant Flow|Mirvaso® / Onreltea TM|Mirvaso® / Onreltea TM
11260607|NCT02637232|OG000|Outcome|Mirvaso® / Onreltea TM|Mirvaso® / Onreltea TM
11260608|NCT02637232|EG000|Reported Event|Mirvaso® / Onreltea TM|Mirvaso® / Onreltea TM
11260609|NCT02637323|BG000|Baseline|FX006 32 mg|Single 5 mL IA injection
11260610|NCT02637323|BG001|Baseline|TCA IR 40 mg|Single 1 mL IA injection
11260611|NCT02637323|BG002|Baseline|Total|Total of all reporting groups
11260612|NCT02637323|FG000|Participant Flow|FX006 32 mg|63 subjects received FX006 32 mg as a single 5 mL IA injection
11260613|NCT02637323|FG001|Participant Flow|TCA IR 40 mg|18 subjects received TCA IR 40 mg as a single 1 mL IA injection
11260614|NCT02637323|OG000|Outcome|FX006 32 mg|Single 5 mL IA injection
11260615|NCT02637323|OG001|Outcome|TCA IR 40 mg|Single 1 mL IA injection
11260616|NCT02637323|OG000|Outcome|FX006 32 mg|Single 5mL IA injection
11260617|NCT02637323|EG000|Reported Event|FX006 32 mg|"Single 5 mL intra-articular injection~FX006: Sustained Release Steroid"
11260618|NCT02637323|EG001|Reported Event|TCA IR 40 mg|"Commercially available triamcinolone acetonide, single 1 mL intra-articular injection~TCA IR: Immediate Release Steroid"
11260619|NCT02637427|BG000|Baseline|Fresh Frozen Plasma Transfusion|"Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)~Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)"
11260620|NCT02637427|BG001|Baseline|No Transfusion|No transfusions prior to the procedure
11260621|NCT02637427|BG002|Baseline|Total|Total of all reporting groups
11260622|NCT02637427|FG000|Participant Flow|Fresh Frozen Plasma Transfusion|"Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)~Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)"
11260623|NCT02637427|FG001|Participant Flow|No Transfusion|No transfusions prior to the procedure
11260624|NCT02637427|OG000|Outcome|Fresh Frozen Plasma Transfusion|"Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)~Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)"
11260625|NCT02637427|OG001|Outcome|No Transfusion|No transfusions prior to the procedure
11260626|NCT02637427|EG000|Reported Event|Fresh Frozen Plasma Transfusion|"Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)~Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)"
11260627|NCT02637427|EG001|Reported Event|No Transfusion|No transfusions prior to the procedure
11260628|NCT02637557|BG000|Baseline|Placebo BID|Matching placebo BID
11260629|NCT02637557|BG001|Baseline|500 mg IW-3718 BID|500 mg IW-3718 BID
11260630|NCT02637557|BG002|Baseline|1000 mg IW-3718 BID|1000 mg IW-3718 BID
11260631|NCT02637557|BG003|Baseline|1500 mg IW-3718 BID|1500 mg IW-3718 BID
11260632|NCT02637557|BG004|Baseline|Total|Total of all reporting groups
11260633|NCT02637557|FG000|Participant Flow|Placebo BID|Matching placebo twice daily (BID)
11260634|NCT02637557|FG001|Participant Flow|500 mg IW-3718 BID|500 mg IW-3718 BID
11260635|NCT02637557|FG002|Participant Flow|1000 mg IW-3718 BID|1000 mg IW-3718 BID
11260636|NCT02637557|FG003|Participant Flow|1500 mg IW-3718 BID|1500 mg IW-3718 BID
11260637|NCT02637557|OG000|Outcome|Placebo BID|Matching placebo BID
11260638|NCT02637557|OG001|Outcome|500 mg IW-3718 BID|500 mg IW-3718 BID
11260639|NCT02637557|OG002|Outcome|1000 mg IW-3718 BID|1000 mg IW-3718 BID
11260640|NCT02637557|OG003|Outcome|1500 mg IW-3718 BID|1500 mg IW-3718 BID
11260641|NCT02637557|EG000|Reported Event|Placebo BID|Matching placebo BID
11260642|NCT02637557|EG001|Reported Event|500 mg IW-3718 BID|500 mg IW-3718 BID
11260643|NCT02637557|EG002|Reported Event|1000 mg IW-3718 BID|1000 mg IW-3718 BID
11260644|NCT02637557|EG003|Reported Event|1500 mg IW-3718 BID|1500 mg IW-3718 BID
11260645|NCT02637804|BG000|Baseline|Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
11260646|NCT02637804|BG001|Baseline|Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
11260647|NCT02637804|BG002|Baseline|Total|Total of all reporting groups
11260648|NCT02637804|FG000|Participant Flow|Stenfilcon A, Then Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
11260649|NCT02637804|FG001|Participant Flow|Narafilcon A, Then Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
11260650|NCT02637804|FG002|Participant Flow|Stenfilcon A, Then Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
11260651|NCT02637804|FG003|Participant Flow|Delefilcon A, Then Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
11260652|NCT02637804|OG000|Outcome|Stenfilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
11260653|NCT02637804|OG001|Outcome|Narafilcon A (Group 1)|"Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~narafilcon A: contact lens"
11260654|NCT02637804|OG002|Outcome|Stenfilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
11260655|NCT02637804|OG003|Outcome|Delefilcon A (Group 2)|"Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.~stenfilcon A: contact lens~delefilcon A: contact lens"
11260656|NCT02637804|OG000|Outcome|Prefer Stenfilcon A|stenfilcon A: contact lens
11260657|NCT02637804|OG001|Outcome|Little Prefer Stenfilcon A|stenfilcon A: contact lens
11260658|NCT02637804|OG002|Outcome|No Preference|No Preference
11260659|NCT02637804|OG003|Outcome|Little Prefer Narafilcon A|narafilcon A: contact lens
11260660|NCT02637804|OG004|Outcome|Prefer Narafilcon A|narafilcon A: contact lens
11260661|NCT02637804|OG003|Outcome|Little Prefer Delefilcon A|delefilcon A: contact lens
11260662|NCT02637804|OG004|Outcome|Prefer Delefilcon A|delefilcon A: contact lens
11260663|NCT02637804|EG000|Reported Event|Stenfilcon A (Group 1)|Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over.
11260664|NCT02637804|EG001|Reported Event|Narafilcon A (Group1)|Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over.
11260665|NCT02637804|EG002|Reported Event|Stenfilcon A (Group 2)|Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over.
11260666|NCT02637804|EG003|Reported Event|Delefilcon A (Group 2)|Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over.
11260667|NCT02637856|BG000|Baseline|Ocrelizumab|Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
11260668|NCT02637856|FG000|Participant Flow|Ocrelizumab|Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
11286660|NCT02891408|FG001|Participant Flow|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11260669|NCT02637856|FG001|Participant Flow|Ocrelizumab (Substudy)|Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
11260670|NCT02637856|OG000|Outcome|Ocrelizumab|Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
11260671|NCT02637856|OG000|Outcome|Ocrelizumab (Substudy)|Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
11260672|NCT02637856|EG000|Reported Event|Ocrelizumab|Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
11260673|NCT02637856|EG001|Reported Event|Ocrelizumab (Substudy)|Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
11260674|NCT02637895|BG000|Baseline|Placebo|"Placebo pill once daily for 12 weeks of active treatment.~Placebo: Placebo pill matching Vortioxetine."
11260675|NCT02637895|BG001|Baseline|Vortioxetine|"Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.~Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12."
11260676|NCT02637895|BG002|Baseline|Total|Total of all reporting groups
11260677|NCT02637895|FG000|Participant Flow|Placebo|"Placebo pill once daily for 12 weeks of active treatment.~Placebo: Placebo pill matching Vortioxetine."
11260678|NCT02637895|FG001|Participant Flow|Vortioxetine|"Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.~Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12."
11260679|NCT02637895|OG000|Outcome|Placebo|"Placebo pill once daily for 12 weeks of active treatment.~Placebo: Placebo pill matching Vortioxetine."
11260680|NCT02637895|OG001|Outcome|Vortioxetine|"Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.~Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12."
11260681|NCT02637895|OG001|Outcome|Vortioxetine|"Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.~Vortioxetine: Immediate Release 10 mg. Vortioxetine Pill"
11260682|NCT02637895|EG000|Reported Event|Placebo|"Placebo pill once daily for 12 weeks of active treatment.~Placebo: Placebo pill matching Vortioxetine."
11260683|NCT02637895|EG001|Reported Event|Vortioxetine|"Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.~Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12."
11260684|NCT02637999|BG000|Baseline|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260685|NCT02637999|BG001|Baseline|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
11260686|NCT02637999|BG002|Baseline|PEG IFN|PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260687|NCT02637999|BG003|Baseline|Total|Total of all reporting groups
11260688|NCT02637999|FG000|Participant Flow|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260689|NCT02637999|FG001|Participant Flow|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks
11260690|NCT02637999|FG002|Participant Flow|PEG IFN|PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260691|NCT02637999|OG000|Outcome|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260692|NCT02637999|OG001|Outcome|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
11260693|NCT02637999|OG002|Outcome|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
11260694|NCT02637999|EG000|Reported Event|MXB Then PEG IFN|Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
11260695|NCT02637999|EG001|Reported Event|MXB + PEG IFN Then PEG IFN|Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 24 weeks, followed by pegINF 180mcg once weekly for 24 weeks
11260696|NCT02637999|EG002|Reported Event|PEG IFN|PEG IFN alfa-2a, 180 µg/0.5 mL once weekly for 48 weeks
11260697|NCT02638012|BG000|Baseline|Floseal Treatment|Patient baseline characteristics
11260698|NCT02638012|FG000|Participant Flow|Floseal Treatment|All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
11260699|NCT02638012|OG000|Outcome|Floseal Treatment|All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
11260700|NCT02638012|EG000|Reported Event|Floseal Treatment|Patient baseline characteristics
11260701|NCT02638051|BG000|Baseline|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
11260702|NCT02638051|BG001|Baseline|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
11260703|NCT02638051|BG002|Baseline|Total|Total of all reporting groups
11260704|NCT02638051|FG000|Participant Flow|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
11260705|NCT02638051|FG001|Participant Flow|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
11260706|NCT02638051|OG000|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
11260707|NCT02638051|OG001|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
11260708|NCT02638051|EG000|Reported Event|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
11260709|NCT02638051|EG001|Reported Event|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
11286661|NCT02891408|FG002|Participant Flow|Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
11286662|NCT02891408|FG003|Participant Flow|Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg|Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11260710|NCT02638103|BG000|Baseline|TEV-48125 225 mg Monthly: New/Placebo Rollover Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260711|NCT02638103|BG001|Baseline|TEV-48125 225 mg Monthly: Active Rollover Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260712|NCT02638103|BG002|Baseline|TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants|Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260713|NCT02638103|BG003|Baseline|TEV-48125 675 mg Quarterly: Active Rollover Participants|Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260714|NCT02638103|BG004|Baseline|Total|Total of all reporting groups
11260715|NCT02638103|FG000|Participant Flow|TEV-48125 225 mg Monthly: New/Placebo Rollover Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab (TEV-48125) 675 milligrams (mg) subcutaneously (SC) as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters [mL] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260716|NCT02638103|FG001|Participant Flow|TEV-48125 225 mg Monthly: Active Rollover Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260717|NCT02638103|FG002|Participant Flow|TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants|Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260718|NCT02638103|FG003|Participant Flow|TEV-48125 675 mg Quarterly: Active Rollover Participants|Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260719|NCT02638103|OG000|Outcome|TEV-48125 225 mg Monthly: New/Placebo Rollover Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11286663|NCT02891408|FG004|Participant Flow|Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg|Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11286664|NCT02891408|FG005|Participant Flow|Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg|Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11260720|NCT02638103|OG001|Outcome|TEV-48125 225 mg Monthly: Active Rollover Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260721|NCT02638103|OG002|Outcome|TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants|Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260722|NCT02638103|OG003|Outcome|TEV-48125 675 mg Quarterly: Active Rollover Participants|Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260723|NCT02638103|OG000|Outcome|TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260724|NCT02638103|OG001|Outcome|TEV-48125 225 mg Monthly: Active Rollover CM Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260725|NCT02638103|OG002|Outcome|TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260726|NCT02638103|OG003|Outcome|TEV-48125 675 mg Quarterly: Active Rollover CM Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260727|NCT02638103|OG004|Outcome|TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants|Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260728|NCT02638103|OG005|Outcome|TEV-48125 225 mg Monthly: Active Rollover EM Participants|Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260729|NCT02638103|OG006|Outcome|TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants|Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260730|NCT02638103|OG007|Outcome|TEV-48125 675 mg Quarterly: Active Rollover EM Participants|Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
11260731|NCT02638103|EG000|Reported Event|TEV-48125 225 mg Monthly: New/Placebo Rollover Participants|Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11286665|NCT02891408|FG006|Participant Flow|Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11260732|NCT02638103|EG001|Reported Event|TEV-48125 225 mg Monthly: Active Rollover Participants|Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260733|NCT02638103|EG002|Reported Event|TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants|Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260734|NCT02638103|EG003|Reported Event|TEV-48125 675 mg Quarterly: Active Rollover Participants|Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
11260735|NCT02638168|BG000|Baseline|With-in Subjects Trial|Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
11260736|NCT02638168|FG000|Participant Flow|Immediate Release Methylphenidate|"With-in subjects trial. Subjects will be randomized to 0.3 mg/kg of Immediate Release Methylphenidate versus placebo over 3-weeks duration~Immediate Release Methylphenidate: The medication assessment procedure will be a double-blind, within-subject evaluation of placebo and matching evening dose of IR MPH rounded to the nearest 2.5mg increment with a max IR MPH dose of 0.3mg/kg. Expected evening dose range will be from 2.5mg to 20mg with most participants receiving between 5 to 15mg per evening dose. Dose will be determined based on current dose of their morning extended release stimulant"
11260737|NCT02638168|FG001|Participant Flow|Placebo|"inert placebo ingredient~Placebo: inert placebo ingredient~We have total 6 screening and recruited 3 patients for this study"
11260738|NCT02638168|OG000|Outcome|With-in Subjects Trial|Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
11260739|NCT02638168|EG000|Reported Event|With-in Subjects Trial|Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
11260740|NCT02638207|BG000|Baseline|0.5 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260741|NCT02638207|BG001|Baseline|1.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260742|NCT02638207|BG002|Baseline|2.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260743|NCT02638207|BG003|Baseline|Total|Total of all reporting groups
11260744|NCT02638207|FG000|Participant Flow|0.5 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260745|NCT02638207|FG001|Participant Flow|1.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260746|NCT02638207|FG002|Participant Flow|2.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260747|NCT02638207|OG000|Outcome|1.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260748|NCT02638207|OG000|Outcome|0.5 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260749|NCT02638207|OG001|Outcome|1.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260750|NCT02638207|OG002|Outcome|2.0 g/kg NewGam|All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
11260751|NCT02638207|EG000|Reported Event|NGAM 0.5 g/kg|NGAM 0.5 g/kg
11260752|NCT02638207|EG001|Reported Event|NGAM 1.0 g/kg|NGAM 1.0 g/kg
11260753|NCT02638207|EG002|Reported Event|NGAM 2.0 g/kg|NGAM 2.0 g/kg
11260754|NCT02638207|EG003|Reported Event|Total|Total of all three treatment arms.
11260755|NCT02638259|BG000|Baseline|50mg GP2015|Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260756|NCT02638259|BG001|Baseline|50mg EU-authorized Enbrel|Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260757|NCT02638259|BG002|Baseline|Total|Total of all reporting groups
11260758|NCT02638259|FG000|Participant Flow|50mg GP2015|Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260759|NCT02638259|FG001|Participant Flow|50mg EU-authorized Enbrel|Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260760|NCT02638259|OG000|Outcome|50mg GP2015|Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260761|NCT02638259|OG001|Outcome|50mg EU-authorized Enbrel|Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator
11260762|NCT02638259|EG000|Reported Event|Treatment Period 1 TP1 SAF GP2015|Treatment Period 1 TP1 SAF GP2015
11260763|NCT02638259|EG001|Reported Event|Treatment Period 1 TP1 SAF Enbrel|Treatment Period 1 TP1 SAF Enbrel
11260764|NCT02638259|EG002|Reported Event|Treatment Period 2 TP2 SAF Continued GP2015|Treatment Period 2 TP2 SAF Continued GP2015
11260765|NCT02638259|EG003|Reported Event|Treatment Period 2 TP2 SAF Enbrel Switched to GP2015|Treatment Period 2 TP2 SAF Enbrel switched to GP2015
11260766|NCT02638259|EG004|Reported Event|Entire Study SAF GP2015|Entire study SAF GP2015
11260767|NCT02638259|EG005|Reported Event|Entire Study SAF Enbrel/GP2015|Entire study SAF Enbrel/GP2015
11260768|NCT02638337|BG000|Baseline|Ospemifene|Participants received one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
11260769|NCT02638337|BG001|Baseline|Placebo|Participants received one tablet of matching placebo, orally, once a day for 12 weeks.
11260770|NCT02638337|BG002|Baseline|Total|Total of all reporting groups
11260771|NCT02638337|FG000|Participant Flow|Ospemifene|Participants received one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
11260772|NCT02638337|FG001|Participant Flow|Placebo|Participants received one tablet of matching placebo, orally, once a day for 12 weeks.
11260773|NCT02638337|OG000|Outcome|Ospemifene|Participants received one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
11260774|NCT02638337|OG001|Outcome|Placebo|Participants received one tablet of matching placebo, orally, once a day for 12 weeks.
11260775|NCT02638337|EG000|Reported Event|Ospemifene|Participants received one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
11260776|NCT02638337|EG001|Reported Event|Placebo|Participants received one tablet of matching placebo, orally, once a day for 12 weeks.
11260777|NCT02638493|BG000|Baseline|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
11260778|NCT02638493|BG001|Baseline|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
11260779|NCT02638493|BG002|Baseline|HIV Positive TAF|8 HIV positive men taking TAF as treatment
11260780|NCT02638493|BG003|Baseline|Total|Total of all reporting groups
11260781|NCT02638493|FG000|Participant Flow|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as treatment
11260782|NCT02638493|FG001|Participant Flow|HIV Negative|8 HIV negative men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as pre-exposure prophylaxis
11260783|NCT02638493|FG002|Participant Flow|HIV Positive TAF|8 HIV positive men taking TAF (Tenofovir Alafenamide) as treatment
11260784|NCT02638493|OG000|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
11260785|NCT02638493|OG001|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
11260786|NCT02638493|OG002|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
11260787|NCT02638493|EG000|Reported Event|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
11260788|NCT02638493|EG001|Reported Event|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
11260789|NCT02638493|EG002|Reported Event|HIV Positive TAF|8 HIV positive men taking TAF as treatment
11260790|NCT02638597|BG000|Baseline|Waitlist|Participants placed on waitlist for medication, otherwise completed study procedures
11260791|NCT02638597|BG001|Baseline|Gemfibrozil|Received gemfibrozil tablets
11260792|NCT02638597|BG002|Baseline|Total|Total of all reporting groups
11260793|NCT02638597|FG000|Participant Flow|Waitlist|Participants placed on waitlist for medication, otherwise completed study procedures
11260794|NCT02638597|FG001|Participant Flow|Gemfibrozil|Received gemfibrozil tablets
11260795|NCT02638597|OG000|Outcome|Gemfibrozil|"Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion~Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)~smoking cessation counseling: smoking cessation counseling"
11260796|NCT02638597|OG001|Outcome|Waitlist|"Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.~smoking cessation counseling: smoking cessation counseling"
11260797|NCT02638597|OG000|Outcome|Waitlist|Participants placed on waitlist for medication, otherwise completed study procedures
11260798|NCT02638597|OG001|Outcome|Gemfibrozil|Received gemfibrozil tablets
11260799|NCT02638597|EG000|Reported Event|Gemfibrozil|"Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion~Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)~smoking cessation counseling: smoking cessation counseling"
11260800|NCT02638597|EG001|Reported Event|Waitlist|"Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.~smoking cessation counseling: smoking cessation counseling"
11260801|NCT02638623|BG000|Baseline|Lactated Ringer Bolus Group|"Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement~Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty"
11260802|NCT02638623|BG001|Baseline|Placebo|"Covered empty bag with no hydration supplement~Placebo: No additional fluids will be administered"
11260803|NCT02638623|BG002|Baseline|Total|Total of all reporting groups
11260804|NCT02638623|FG000|Participant Flow|Lactated Ringer Bolus Group|"Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement~Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty"
11260805|NCT02638623|FG001|Participant Flow|Placebo|"Covered empty bag with no hydration supplement~Placebo: No additional fluids will be administered"
11260806|NCT02638623|OG000|Outcome|Lactated Ringer Bolus Group|"Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement~Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty"
11260807|NCT02638623|OG001|Outcome|Placebo|"Covered empty bag with no hydration supplement~Placebo: No additional fluids will be administered"
11260808|NCT02638623|EG000|Reported Event|Lactated Ringer Bolus Group|"Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement~Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty"
11260809|NCT02638623|EG001|Reported Event|Placebo|"Covered empty bag with no hydration supplement~Placebo: No additional fluids will be administered"
11260810|NCT02638948|BG000|Baseline|Placebo|Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
11260811|NCT02638948|BG001|Baseline|BMS 100mg|Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
11260812|NCT02638948|BG002|Baseline|BMS 200mg|Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
11260813|NCT02638948|BG003|Baseline|BMS 350mg|Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
11260814|NCT02638948|BG004|Baseline|Total|Total of all reporting groups
11260815|NCT02638948|FG000|Participant Flow|Placebo|Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
11260816|NCT02638948|FG001|Participant Flow|BMS 100mg|Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
11260817|NCT02638948|FG002|Participant Flow|BMS 200mg|Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
11260818|NCT02638948|FG003|Participant Flow|BMS 350mg|Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
11260819|NCT02638948|OG000|Outcome|Placebo|Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
11260820|NCT02638948|OG001|Outcome|BMS 100mg|Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
11260821|NCT02638948|OG002|Outcome|BMS 200mg|Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
11260822|NCT02638948|OG003|Outcome|BMS 350mg|Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
11260823|NCT02638948|OG000|Outcome|BMS 100mg|Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
11260824|NCT02638948|OG001|Outcome|BMS 200mg|Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
11260825|NCT02638948|OG002|Outcome|BMS 350mg|Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
11260826|NCT02638948|EG000|Reported Event|BMS-986142 100mg|Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
11260827|NCT02638948|EG001|Reported Event|BMS-986142 200mg|Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
11260828|NCT02638948|EG002|Reported Event|BMS-986142 350mg|Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
11260829|NCT02638948|EG003|Reported Event|Placebo|Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
11260830|NCT02638974|BG000|Baseline|Medical Skin Camouflage|"This arm will use medical skin camouflage for 6 weeks~Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions"
11260831|NCT02638974|BG001|Baseline|Wait List Control|This arm will receive medical skin camouflage at the end of the study
11260832|NCT02638974|BG002|Baseline|Total|Total of all reporting groups
11260833|NCT02638974|FG000|Participant Flow|Medical Skin Camouflage|"This arm will use medical skin camouflage for 6 weeks~Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions"
11260834|NCT02638974|FG001|Participant Flow|Wait List Control|This arm will receive medical skin camouflage at the end of the study
11260835|NCT02638974|OG000|Outcome|Medical Skin Camouflage|"This arm will use medical skin camouflage for 6 weeks~Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions"
11260836|NCT02638974|OG001|Outcome|Wait List Control|This arm will receive medical skin camouflage at the end of the study
11260837|NCT02638974|EG000|Reported Event|Medical Skin Camouflage|"This arm will use medical skin camouflage for 6 weeks~Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions"
11260838|NCT02638974|EG001|Reported Event|Wait List Control|This arm will receive medical skin camouflage at the end of the study
11286666|NCT02891408|OG000|Outcome|Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg|Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11260839|NCT02639052|BG000|Baseline|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
11260840|NCT02639052|FG000|Participant Flow|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
11260841|NCT02639052|OG000|Outcome|Botox|10 units of Botox intradermally injected into one forearm
11260842|NCT02639052|OG001|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
11260843|NCT02639052|EG000|Reported Event|Botox|10 units of Botox intradermally injected into one forearm
11260844|NCT02639052|EG001|Reported Event|Saline|Saline vehicle intradermally injected into the other forearm
11260845|NCT02639182|BG000|Baseline|AGS-16C3F|Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
11260846|NCT02639182|BG001|Baseline|Axitinib|Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
11260847|NCT02639182|BG002|Baseline|Total|Total of all reporting groups
11260848|NCT02639182|FG000|Participant Flow|AGS-16C3F|Participants received 1.8 milligram per kilogram (mg/kg) of AGS-16C3F once every three weeks by single (60-minute) intravenous (IV) infusion.
11260849|NCT02639182|FG001|Participant Flow|Axitinib|Participants received axitinib at a starting dose of 5 milligram (mg) orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
11260850|NCT02639182|OG000|Outcome|AGS-16C3F|Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
11260851|NCT02639182|OG001|Outcome|Axitinib|Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
11260852|NCT02639182|EG000|Reported Event|AGS-16C3F|Participants received 1.8 mg/kg of AGS-16C3F once every three weeks by single (60-minute) IV infusion.
11260853|NCT02639182|EG001|Reported Event|Axitinib|Participants received axitinib at a starting dose of 5 mg orally twice daily and then adjusted to 2 to 10 mg orally twice daily, as defined in the product label and per local institutional guidelines.
11260854|NCT02639247|BG000|Baseline|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11260855|NCT02639247|BG001|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260856|NCT02639247|BG002|Baseline|Total|Total of all reporting groups
11260857|NCT02639247|FG000|Participant Flow|SOF/VEL/VOX 12 Weeks|Sofosbuvir/veltapasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
11260858|NCT02639247|FG001|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260859|NCT02639247|OG000|Outcome|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11260860|NCT02639247|OG001|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260861|NCT02639247|EG000|Reported Event|SOF/VEL/VOX 12 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
11260862|NCT02639247|EG001|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260863|NCT02639286|BG000|Baseline|Placebo|Placebo administered via SC
11260864|NCT02639286|BG001|Baseline|ISIS 304801|300 mg of ISIS 304801 administered as SC
11260865|NCT02639286|BG002|Baseline|Total|Total of all reporting groups
11260866|NCT02639286|FG000|Participant Flow|Placebo|Placebo administered via SC
11260867|NCT02639286|FG001|Participant Flow|ISIS 304801|300 mg of ISIS 304801 administered as SC
11260868|NCT02639286|OG000|Outcome|Placebo|Placebo administered via SC
11260869|NCT02639286|OG001|Outcome|ISIS 304801|300 mg of ISIS 304801 administered as SC
11260870|NCT02639286|EG000|Reported Event|Placebo|Placebo administered via SC
11260871|NCT02639286|EG001|Reported Event|ISIS 304801|300 mg of ISIS 304801 administered as SC
11260872|NCT02639338|BG000|Baseline|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
11260873|NCT02639338|BG001|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) tablet orally once daily without regard to food for 12 weeks
11260874|NCT02639338|BG002|Baseline|Total|Total of all reporting groups
11260875|NCT02639338|FG000|Participant Flow|SOF/VEL/VOX 8 Weeks|Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 weeks
11260876|NCT02639338|FG001|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260877|NCT02639338|OG000|Outcome|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
11260878|NCT02639338|OG001|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260879|NCT02639338|EG000|Reported Event|SOF/VEL/VOX 8 Weeks|SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
11260880|NCT02639338|EG001|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
11260881|NCT02639351|BG000|Baseline|LHD153R Formulation 1 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.
11260882|NCT02639351|BG001|Baseline|LHD153R Formulation 2 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.
11260883|NCT02639351|BG002|Baseline|LHD153R Formulation 3 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.
11260884|NCT02639351|BG003|Baseline|LHD153R Formulation 4 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.
11260885|NCT02639351|BG004|Baseline|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
11260886|NCT02639351|BG005|Baseline|Total|Total of all reporting groups
11260887|NCT02639351|FG000|Participant Flow|LHD153R Formulation 1 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.
11260888|NCT02639351|FG001|Participant Flow|LHD153R Formulation 2 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.
11260889|NCT02639351|FG002|Participant Flow|LHD153R Formulation 3 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.
11260890|NCT02639351|FG003|Participant Flow|LHD153R Formulation 4 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.
11260891|NCT02639351|FG004|Participant Flow|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of Meningococcal C-CRM conjugate vaccine (MenC-CRM).
11260892|NCT02639351|OG000|Outcome|LHD153R Formulation 1 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.
11260893|NCT02639351|OG001|Outcome|LHD153R Formulation 2 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.
11260894|NCT02639351|OG002|Outcome|LHD153R Formulation 3 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.
11260895|NCT02639351|OG003|Outcome|LHD153R Formulation 4 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.
11260896|NCT02639351|OG004|Outcome|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
11260897|NCT02639351|OG004|Outcome|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM.
11260898|NCT02639351|OG004|Outcome|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine .
11260899|NCT02639351|EG000|Reported Event|LHD153R Formulation 1 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.
11260900|NCT02639351|EG001|Reported Event|LHD153R Formulation 2 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.
11260901|NCT02639351|EG002|Reported Event|LHD153R Formulation 3 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.
11260902|NCT02639351|EG003|Reported Event|LHD153R Formulation 4 Group|Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.
11260903|NCT02639351|EG004|Reported Event|MenC Group|Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
11260904|NCT02639429|BG000|Baseline|Combined Approach: Foley Balloon + Vaginal Misoprostol|"These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.~Foley Balloon + Vaginal Misoprostol"
11260905|NCT02639429|BG001|Baseline|Single Approach: Vaginal Misoprostol Only|"These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.~Vaginal Misoprostol"
11260906|NCT02639429|BG002|Baseline|Total|Total of all reporting groups
11260907|NCT02639429|FG000|Participant Flow|Combined Approach: Foley Balloon + Vaginal Misoprostol|"These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.~Foley Balloon + Vaginal Misoprostol"
11260908|NCT02639429|FG001|Participant Flow|Single Approach: Vaginal Misoprostol Only|"These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.~Vaginal Misoprostol"
11260909|NCT02639429|OG000|Outcome|Combined Approach: Foley Balloon + Vaginal Misoprostol|"These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.~Foley Balloon + Vaginal Misoprostol"
11260910|NCT02639429|OG001|Outcome|Single Approach: Vaginal Misoprostol Only|"These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.~Vaginal Misoprostol"
11260911|NCT02639429|EG000|Reported Event|Combined Approach: Foley Balloon + Vaginal Misoprostol|"These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.~Foley Balloon + Vaginal Misoprostol"
11260912|NCT02639429|EG001|Reported Event|Single Approach: Vaginal Misoprostol Only|"These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.~Vaginal Misoprostol"
11260913|NCT02639494|BG000|Baseline|Self-Centering Guide Catheter|Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
11260914|NCT02639494|FG000|Participant Flow|Self-Centering Guide Catheter|Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
11260915|NCT02639494|OG000|Outcome|Self-Centering Guide Catheter|Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
11260916|NCT02639494|EG000|Reported Event|Self-Centering Guide Catheter|Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
11260917|NCT02639637|BG000|Baseline|Controls Who Completed Crossover Arm 1 or 2|Healthy non-smokers Crossover arm 1 is sitagliptin then placebo Crossover arm 2 is placebo then sitagliptin
11260918|NCT02639637|BG001|Baseline|Patients With Diabetes Who Completed Crossover Arm 1 or 2|Non-smokers with diabetes who were taking no medication or metformin only Crossover arm 1 is sitagliptin then placebo Crossover arm 2 is placebo then sitagliptin
11260919|NCT02639637|BG002|Baseline|Controls Who Completed Crossover Arm 3 or 4|Healthy non-smokers Crossover arm 3 is sitagliptin and valsartan, then placebo and valsartan Crossover arm 4 is placebo and valsartan, then sitagliptin and valsartan
11260920|NCT02639637|BG003|Baseline|Total|Total of all reporting groups
11260921|NCT02639637|FG000|Participant Flow|Sitagliptin Then Placebo (Diabetics and Controls)|"Subjects in this arm will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for study day #1. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. A four week washout of medications will occur after the study day. Subjects will then receive placebo for one week followed by study day #2.~Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260922|NCT02639637|FG001|Participant Flow|Placebo Then Sitagliptin (Diabetics and Controls)|"Subjects in this arm will receive placebo for one week. After this, subjects will report for study day #1. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. A four week washout of medications will occur after the study day. Subjects will then receive 100 mg of sitagliptin daily for one week followed by study day #2.~Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260923|NCT02639637|FG002|Participant Flow|Sitagliptin Then Placebo: Valsartan (Controls Only)|"Subjects in this arm will receive sitagliptin 100 mg/d for one week as well as valsartan 160 mg/d for one week. After this subjects will report for study day #1. During the study day, subjects will be given intra-arterial neuropeptide Y. A four week washout of medication will occur after the study day. Subjects will then receive placebo/d and valsartan 160 mg/d for one week followed by study day #2.~Sitagliptin: Subjects will receive sitagliptin 100 mg daily for 7 days prior to one of the study days.~Placebo: Subjects will receive a placebo capsule daily for 7 days prior to one of the study days.~Valsartan 160mg: Valsartan 160 mg/d for 7 days prior to one of the study days."
11286667|NCT02891408|OG001|Outcome|Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286668|NCT02891408|OG002|Outcome|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11260924|NCT02639637|FG003|Participant Flow|Placebo Then Sitagliptin: Valsartan (Controls Only)|"Subjects in this arm will receive placebo/d for one week as well as valsartan 160 mg/d for one week. After this subjects will report for study day #1. During the study day, subjects will be given intra-arterial neuropeptide Y. A four week washout of medication will occur after the study day. Subjects will then receive sitagliptin 100mg/d and valsartan 160 mg/d for one week followed by study day #2.~Sitagliptin: Subjects will receive sitagliptin 100 mg daily for 7 days prior to one of the study days.~Placebo: Subjects will receive a placebo capsule daily for 7 days prior to one of the study days.~Valsartan 160mg: Valsartan 160 mg/d for 7 days prior to one of the study days."
11260925|NCT02639637|OG000|Outcome|Sitagliptin and Enalaprilat (Diabetics and Controls)|"Subjects will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260926|NCT02639637|OG001|Outcome|Placebo and Enalaprilat (Diabetics and Controls)|"Subjects will receive placebo 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260927|NCT02639637|OG002|Outcome|Sitagliptin and Valsartan (Controls Only)|Subjects in this arm will receive sitagliptin 100 mg/d for one week as well as valsartan 160 mg/d for one week. After this subjects will report for a study day. During the study day, subjects will be given intra-arterial neuropeptide Y.
11260928|NCT02639637|OG003|Outcome|Placebo and Valsartan (Controls Only)|Subjects in this arm will receive a placebo for one week as well as valsartan 160 mg/d for one week. After this subjects will report for a study day. During the study day, subjects will be given intra-arterial neuropeptide Y.
11260929|NCT02639637|OG000|Outcome|Sitagliptin + Enalaprilat (Diabetics and Controls)|"Subjects will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260930|NCT02639637|OG001|Outcome|Placebo + Enalaprilat (Diabetics and Controls)|"Subjects will receive placebo 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260931|NCT02639637|OG000|Outcome|Sitagliptin (Diabetics)|"Subjects will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260932|NCT02639637|OG001|Outcome|Placebo (Diabetics)|"Subjects will receive placebo 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260933|NCT02639637|OG000|Outcome|Sitagliptin (Diabetics and Controls)|"Subjects will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11286669|NCT02891408|OG003|Outcome|Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286670|NCT02891408|OG004|Outcome|Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg|Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11260934|NCT02639637|OG001|Outcome|Placebo (Diabetics and Controls)|"Subjects will receive placebo 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260935|NCT02639637|EG000|Reported Event|Sitagliptin (Diabetics and Controls)|"Subjects will receive sitagliptin 100 mg daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260936|NCT02639637|EG001|Reported Event|Placebo (Diabetics and Controls)|"Subjects will receive placebo daily. After one week of treatment, subjects will report for a study day. During the study day subjects will be given intra-aterial neuropeptide Y and enalaprilat. Neuropeptide Y: During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.~Enalaprilat: Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second After 30 minutes, a second NPY at graded doses was started ten minutes after that."
11260937|NCT02639637|EG002|Reported Event|Sitagliptin and Valsartan (Controls Only)|Subjects in this arm will receive sitagliptin 100 mg/d for one week as well as valsartan 160 mg/d for one week. After this subjects will report for a study day. During the study day, subjects will be given intra-arterial neuropeptide Y
11260938|NCT02639637|EG003|Reported Event|Placebo and Valsartan (Controls Only)|Subjects in this arm will receive splacebo for one week as well as valsartan 160 mg/d for one week. After this subjects will report for a study day. During the study day, subjects will be given intra-arterial neuropeptide Y
11260939|NCT02639884|BG000|Baseline|Evaluation Group|All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring.
11260940|NCT02639884|FG000|Participant Flow|Evaluation Group|"All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring~SedLine EEG~RRa monitoring"
11260941|NCT02639884|OG000|Outcome|Evaluation Group|"All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring~SedLine EEG~RRa monitoring"
11260942|NCT02639884|OG000|Outcome|Evaluation Group|All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
11260943|NCT02639884|EG000|Reported Event|Evaluation Group|All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
11260944|NCT02640053|BG000|Baseline|Arm I (Cryotherapy)|Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
11260945|NCT02640053|BG001|Baseline|Arm II (Control)|Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
11260946|NCT02640053|BG002|Baseline|Total|Total of all reporting groups
11260947|NCT02640053|FG000|Participant Flow|Arm I (Cryotherapy)|Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
11260948|NCT02640053|FG001|Participant Flow|Arm II (Control)|Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
11260949|NCT02640053|OG000|Outcome|Arm I (Cryotherapy)|Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
11260950|NCT02640053|OG001|Outcome|Arm II (Control)|Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
11260951|NCT02640053|EG000|Reported Event|Arm I (Cryotherapy)|Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
11260952|NCT02640053|EG001|Reported Event|Arm II (Control)|Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
11260953|NCT02640157|BG000|Baseline|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260954|NCT02640157|BG001|Baseline|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
11260955|NCT02640157|BG002|Baseline|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11260956|NCT02640157|BG003|Baseline|Total|Total of all reporting groups
11260957|NCT02640157|FG000|Participant Flow|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260958|NCT02640157|FG001|Participant Flow|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
11260959|NCT02640157|FG002|Participant Flow|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11260960|NCT02640157|OG000|Outcome|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260961|NCT02640157|OG001|Outcome|Arm B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
11260962|NCT02640157|OG001|Outcome|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11260963|NCT02640157|OG002|Outcome|Arm C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11260964|NCT02640157|EG000|Reported Event|Arm A|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11260965|NCT02640157|EG001|Reported Event|ARM B|Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
11260966|NCT02640157|EG002|Reported Event|ARM C|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
11260967|NCT02640235|BG000|Baseline|CELSTAT|"Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site~CELSTAT"
11260968|NCT02640235|BG001|Baseline|Surgicel Original|"Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site~Surgicel Original"
11260969|NCT02640235|BG002|Baseline|Total|Total of all reporting groups
11260970|NCT02640235|FG000|Participant Flow|CELSTAT|"Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site~CELSTAT"
11260971|NCT02640235|FG001|Participant Flow|Surgicel Original|"Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site~Surgicel Original"
11260972|NCT02640235|OG000|Outcome|CELSTAT|"Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site~CELSTAT"
11260973|NCT02640235|OG001|Outcome|Surgicel Original|"Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site~Surgicel Original"
11260974|NCT02640235|EG000|Reported Event|CELSTAT|"Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site~CELSTAT"
11260975|NCT02640235|EG001|Reported Event|Surgicel Original|"Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site~Surgicel Original"
11260976|NCT02640404|BG000|Baseline|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
11260977|NCT02640404|BG001|Baseline|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
11260978|NCT02640404|BG002|Baseline|Total|Total of all reporting groups
11260979|NCT02640404|FG000|Participant Flow|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
11260980|NCT02640404|FG001|Participant Flow|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
11260981|NCT02640404|OG000|Outcome|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
11260982|NCT02640404|OG000|Outcome|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
11260983|NCT02640404|EG000|Reported Event|Menactra® Vaccine (9 to 23 Months)|Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
11260984|NCT02640404|EG001|Reported Event|Menactra® Vaccine (2 to 55 Years)|Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
11260985|NCT02640482|BG000|Baseline|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
11260986|NCT02640482|BG001|Baseline|Arm B DB Placebo Then OL Active Drug|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
11260987|NCT02640482|BG002|Baseline|Total|Total of all reporting groups
11260988|NCT02640482|FG000|Participant Flow|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
11260989|NCT02640482|FG001|Participant Flow|Arm B DB Placebo Then OL Active Drug|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
11260990|NCT02640482|OG000|Outcome|Arm A DB Active Drug|Arm A DB Active Drug: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
11260991|NCT02640482|EG000|Reported Event|Arm A DB Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
11260992|NCT02640482|EG001|Reported Event|Arm B DB Placebo|Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)
11260993|NCT02640482|EG002|Reported Event|Arm B OL Active Drug|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
11260994|NCT02640547|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11286671|NCT02891408|OG005|Outcome|Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg|Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11286672|NCT02891408|OG006|Outcome|Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg|Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11260995|NCT02640547|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11260996|NCT02640547|OG000|Outcome|Genotype 1 (Total)|Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11260997|NCT02640547|OG001|Outcome|Genotype 1a|Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11260998|NCT02640547|OG002|Outcome|Genotype 1b|Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11260999|NCT02640547|OG003|Outcome|Genotype 4|Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11261000|NCT02640547|OG000|Outcome|2 DAA + RBV|Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
11261001|NCT02640547|OG001|Outcome|3 DAA Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.
11261002|NCT02640547|OG002|Outcome|3 DAA + RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11261003|NCT02640547|EG000|Reported Event|2 DAA + RBV|Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
11261004|NCT02640547|EG001|Reported Event|3 DAA Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.
11261005|NCT02640547|EG002|Reported Event|3 DAA + RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11261006|NCT02640612|BG000|Baseline|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.
11261007|NCT02640612|BG001|Baseline|Humira® to Humira®|Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261008|NCT02640612|BG002|Baseline|Humira® to BI 695501|Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261009|NCT02640612|BG003|Baseline|Total|Total of all reporting groups
11261010|NCT02640612|FG000|Participant Flow|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.
11261011|NCT02640612|FG001|Participant Flow|Humira® to Humira®|Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261012|NCT02640612|FG002|Participant Flow|Humira® to BI 695501|Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261013|NCT02640612|OG000|Outcome|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.
11261014|NCT02640612|OG001|Outcome|Humira® to Humira®|Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261015|NCT02640612|OG002|Outcome|Humira® to BI 695501|Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261016|NCT02640612|EG000|Reported Event|BI 695501 to BI 695501|Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.
11261017|NCT02640612|EG001|Reported Event|Humira® to Humira®|Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261018|NCT02640612|EG002|Reported Event|Humira® to BI 695501|Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
11261019|NCT02640716|BG000|Baseline|Training Group|"Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.~multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels."
11261020|NCT02640716|BG001|Baseline|Control Group|"Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.~placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set."
11261021|NCT02640716|BG002|Baseline|Total|Total of all reporting groups
11261022|NCT02640716|FG000|Participant Flow|Training Group|"Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.~multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels."
11261023|NCT02640716|FG001|Participant Flow|Control Group|"Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.~placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set."
11261024|NCT02640716|OG000|Outcome|Training Group|"Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.~multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels."
11261025|NCT02640716|OG001|Outcome|Control Group|"Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.~placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set."
11261026|NCT02640716|EG000|Reported Event|Training Group|"Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.~multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels."
11261027|NCT02640716|EG001|Reported Event|Control Group|"Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.~placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set."
11261028|NCT02640755|BG000|Baseline|[14C]-AZD2014 Then AZD2014 Monotherapy|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue non-radiolabelled AZD2014 (AZD2014 monotherapy), which was administered as an oral tablet. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261029|NCT02640755|BG001|Baseline|[14C]-AZD2014 Then AZD2014 + Fulvestrant|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue AZD2014, which was administered as an oral tablet, in combination with standard regimens of fulvestrant therapy. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261030|NCT02640755|BG002|Baseline|Total|Total of all reporting groups
11286673|NCT02891408|OG007|Outcome|Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11286674|NCT02891408|OG002|Outcome|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
11261031|NCT02640755|FG000|Participant Flow|[14C]-AZD2014 Then AZD2014 Monotherapy|"Single Dose Period: Patients were given a single oral dose of radiolabelled AZD2014 ([14C]-AZD2014) as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue non-radiolabelled AZD2014 (AZD2014 monotherapy), which was administered as an oral tablet. Patients continued treatment as outpatients until withdrawal due to adverse events (AEs), withdrawal of consent, progression of disease according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261032|NCT02640755|FG001|Participant Flow|[14C]-AZD2014 Then AZD2014 + Fulvestrant|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue AZD2014, which was administered as an oral tablet, in combination with standard regimens of fulvestrant therapy. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261033|NCT02640755|OG000|Outcome|[14C]-AZD2014 (Period 1 [Day 1 - 8])|"125 mg [14C]-AZD2014 single oral dose was administered on Day 1. Patients fasted for 2 hours before or 1 hour after administration, and were administered prophylactic anti-emetics.~Samples of whole blood, plasma, urine, faeces, saliva and biofluid (vomit) were collected at various time points up to 168 h post-dose to characterise the absorption, metabolism, excretion and PK of AZD2014."
11261034|NCT02640755|OG000|Outcome|[14C]-AZD2014 Then AZD2014 Monotherapy|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue non-radiolabelled AZD2014 (AZD2014 monotherapy), which was administered as an oral tablet. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261035|NCT02640755|OG001|Outcome|[14C]-AZD2014 Then AZD2014 + Fulvestrant|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue AZD2014, which was administered as an oral tablet, in combination with standard regimens of fulvestrant therapy. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261036|NCT02640755|EG000|Reported Event|[14C]-AZD2014 Then AZD2014 Monotherapy|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic predose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue non-radiolabelled AZD2014 (AZD2014 monotherapy), which was administered as an oral tablet. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261037|NCT02640755|EG001|Reported Event|[14C]-AZD2014 Then AZD2014 + Fulvestrant|"Single Dose Period: Patients were given a single oral dose of [14C]-AZD2014 as an oral solution on Day 1 of the first treatment period (Cycle 0). Patients were admitted to the study clinic pre-dose on Day 1 until at least Day 8 (168 hours post-dose).~Multiple Dose Period: From Day 1 Cycle 1, patients could continue AZD2014, which was administered as an oral tablet, in combination with standard regimens of fulvestrant therapy. Patients continued treatment as outpatients until withdrawal due to AEs, withdrawal of consent, progression of disease according to RECIST 1.1, until the patient was no longer receiving clinical benefit or the patient started any new anti-cancer therapy."
11261038|NCT02640807|BG000|Baseline|CYT107 High Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000"
11261039|NCT02640807|BG001|Baseline|CYT107 Low Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261040|NCT02640807|BG002|Baseline|Control|"Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261041|NCT02640807|BG003|Baseline|Total|Total of all reporting groups
11261042|NCT02640807|FG000|Participant Flow|CYT107 High Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000"
11261043|NCT02640807|FG001|Participant Flow|CYT107 Low Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261044|NCT02640807|FG002|Participant Flow|Control|"Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261045|NCT02640807|OG000|Outcome|CYT107 High Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000"
11261046|NCT02640807|OG001|Outcome|CYT107 Low Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261047|NCT02640807|OG002|Outcome|Control|"Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261048|NCT02640807|EG000|Reported Event|CYT107 High Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000"
11261049|NCT02640807|EG001|Reported Event|CYT107 Low Frequency|"Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks~Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261050|NCT02640807|EG002|Reported Event|Control|"Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks~Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000"
11261051|NCT02641067|BG000|Baseline|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 100 mg doravirine
11261052|NCT02641067|BG001|Baseline|Healthy Matched Controls|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine
11261053|NCT02641067|BG002|Baseline|Total|Total of all reporting groups
11261054|NCT02641067|FG000|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 100 mg doravirine
11261055|NCT02641067|FG001|Participant Flow|Healthy Matched Controls|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine
11261056|NCT02641067|OG000|Outcome|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 100 mg doravirine
11261057|NCT02641067|OG001|Outcome|Healthy Matched Controls|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine
11261058|NCT02641067|EG000|Reported Event|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 100 mg doravirine
11261059|NCT02641067|EG001|Reported Event|Healthy Matched Control|Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine
11261060|NCT02641080|BG000|Baseline|Aspirin|"Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261061|NCT02641080|BG001|Baseline|Aspirin With Portable Compression Device|"Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.~Portable Compression Device: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261062|NCT02641080|BG002|Baseline|Total|Total of all reporting groups
11261063|NCT02641080|FG000|Participant Flow|Aspirin|"Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261064|NCT02641080|FG001|Participant Flow|Aspirin With Portable Compression Device|"Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.~Portable Compression Device: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261065|NCT02641080|OG000|Outcome|Aspirin|"Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11286675|NCT02891408|OG002|Outcome|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286676|NCT02891408|OG001|Outcome|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11261066|NCT02641080|OG001|Outcome|Aspirin With Portable Compression Device|"Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.~Portable Compression Device: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261067|NCT02641080|EG000|Reported Event|Aspirin|"Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261068|NCT02641080|EG001|Reported Event|Aspirin With Portable Compression Device|"Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.~Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.~Portable Compression Device: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device."
11261069|NCT02641249|BG000|Baseline|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
11261070|NCT02641249|FG000|Participant Flow|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
11261071|NCT02641249|OG000|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
11261072|NCT02641249|OG001|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
11261073|NCT02641249|EG000|Reported Event|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
11261074|NCT02641353|BG000|Baseline|Total|"Participants received a single dose of the following three treatments in one of six treatment sequences:~Treatment A: Single oral dose of 30 mg apremilast tablet under fasted conditions~Treatment B: Single oral dose of 30 mg apremilast oral suspension formulation under fasted conditions~Treatment C: Single oral dose of 30 mg apremilast oral suspension formulation under fed conditions"
11261075|NCT02641353|FG000|Participant Flow|Sequence 1: Treatments ACB|Participants received 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 1, 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 2, and 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 3.
11261076|NCT02641353|FG001|Participant Flow|Sequence 2: Treatments CBA|Participants received 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 1, 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 2, and 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 3.
11261077|NCT02641353|FG002|Participant Flow|Sequence 3: Treatments BAC|Participants received 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 1, 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 2, and 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 3.
11261078|NCT02641353|FG003|Participant Flow|Sequence 4: Treatments ABC|Participants received 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 1, 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 2, and 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 3.
11261079|NCT02641353|FG004|Participant Flow|Sequence 5: Treatments CAB|Participants received 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 1, 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 2, and 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 3.
11261080|NCT02641353|FG005|Participant Flow|Sequence 6: Treatments BCA|Participants received 30 mg apremilast oral suspension after an overnight fast on day 1 of treatment period 1, 30 mg apremilast oral suspension after a high-fat meal on day 1 of treatment period 2, and 30 mg apremilast oral tablet after an overnight fast on day 1 of treatment period 3.
11261081|NCT02641353|OG000|Outcome|Treatment A: Apremilast 30 mg Tablet - Fasted|A single oral dose of 30 mg apremilast tablet after an overnight fast.
11261082|NCT02641353|OG001|Outcome|Treatment B: Apremilast 30 mg Oral Suspension - Fasted|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast.
11261083|NCT02641353|OG002|Outcome|Treatment C: Apremilast 30 mg Oral Suspension - Fed|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.
11261084|NCT02641353|OG000|Outcome|Treatment B: Apremilast 30 mg Oral Suspension - Fasted|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast.
11261085|NCT02641353|OG001|Outcome|Treatment C: Apremilast 30 mg Oral Suspension - Fed|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.
11261086|NCT02641353|EG000|Reported Event|Treatment A: Apremilast 30 mg Tablet - Fasted|A single oral dose of 30 mg apremilast tablet after an overnight fast.
11261087|NCT02641353|EG001|Reported Event|Treatment B: Apremilast 30 mg Oral Suspension - Fasted|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast.
11261088|NCT02641353|EG002|Reported Event|Treatment C: Apremilast 30 mg Oral Suspension - Fed|A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.
11261089|NCT02641353|EG003|Reported Event|Total|"Participants received a single dose of the following three treatments in one of six treatment sequences:~Treatment A: Single oral dose of 30 mg apremilast tablet under fasted conditions~Treatment B: Single oral dose of 30 mg apremilast oral suspension formulation under fasted conditions~Treatment C: Single oral dose of 30 mg apremilast oral suspension formulation under fed conditions"
11261090|NCT02641379|BG000|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261091|NCT02641379|BG001|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261092|NCT02641379|BG002|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
11261093|NCT02641379|BG003|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261094|NCT02641379|BG004|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261095|NCT02641379|BG005|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261096|NCT02641379|BG006|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11286677|NCT02891408|OG002|Outcome|Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
11261097|NCT02641379|BG007|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
11261098|NCT02641379|BG008|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261099|NCT02641379|BG009|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
11261100|NCT02641379|BG010|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261101|NCT02641379|BG011|Baseline|Total|Total of all reporting groups
11261102|NCT02641379|FG000|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261103|NCT02641379|FG001|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261104|NCT02641379|FG002|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
11261105|NCT02641379|FG003|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261106|NCT02641379|FG004|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261107|NCT02641379|FG005|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261108|NCT02641379|FG006|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261109|NCT02641379|FG007|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
11261110|NCT02641379|FG008|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261111|NCT02641379|FG009|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
11261112|NCT02641379|FG010|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261113|NCT02641379|OG000|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261114|NCT02641379|OG001|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261115|NCT02641379|OG000|Outcome|PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261116|NCT02641379|OG001|Outcome|PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261117|NCT02641379|OG002|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
11261118|NCT02641379|OG002|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
11261119|NCT02641379|OG003|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11286678|NCT02891408|OG003|Outcome|Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg|Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11261120|NCT02641379|OG004|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261121|NCT02641379|OG000|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261122|NCT02641379|OG001|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261123|NCT02641379|OG002|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
11261124|NCT02641379|OG003|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261125|NCT02641379|OG000|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
11261126|NCT02641379|OG001|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261127|NCT02641379|OG004|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
11261128|NCT02641379|OG005|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261129|NCT02641379|EG000|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261130|NCT02641379|EG001|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11286679|NCT02891408|OG004|Outcome|Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg|Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11286680|NCT02891408|OG005|Outcome|Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg|Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11261131|NCT02641379|EG002|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
11261132|NCT02641379|EG003|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261133|NCT02641379|EG004|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11261134|NCT02641379|EG005|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261135|NCT02641379|EG006|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
11261136|NCT02641379|EG007|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
11261137|NCT02641379|EG008|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
11261138|NCT02641379|EG009|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
11261139|NCT02641379|EG010|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
11286681|NCT02891408|OG006|Outcome|Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11286682|NCT02891408|OG002|Outcome|Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286683|NCT02891408|EG000|Reported Event|Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg|Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286684|NCT02891408|EG001|Reported Event|Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg|Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
11286685|NCT02891408|EG002|Reported Event|Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
11286686|NCT02891408|EG003|Reported Event|Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg|Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11286687|NCT02891408|EG004|Reported Event|Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg|Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
11261140|NCT02641392|BG000|Baseline|GED-0301 40 mg 4 Weeks Alt|Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208
11261141|NCT02641392|BG001|Baseline|GED-0301 40 mg|Participants received continuous GED-0301 40 mg daily, up to week 208.
11261142|NCT02641392|BG002|Baseline|GED-0301 160 mg 4 Weeks Alt|"Participants received one of three dose regimens up to week 208:~1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks"
11261143|NCT02641392|BG003|Baseline|Total|Total of all reporting groups
11261144|NCT02641392|FG000|Participant Flow|GED-0301 40 mg 4 Weeks Alt|Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208
11261145|NCT02641392|FG001|Participant Flow|GED-0301 40 mg|Participants received continuous GED-0301 40 mg daily, up to week 208.
11261146|NCT02641392|FG002|Participant Flow|GED-0301 160 mg 4 Weeks Alt|"Participants received one of three dose regimens up to week 208:~1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks"
11261147|NCT02641392|OG000|Outcome|GED 40 mg 4 Weeks Alt|Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208
11261148|NCT02641392|OG001|Outcome|GED-0301 40 mg|Participants received continuous GED-0301 40 mg daily, up to week 208.
11261149|NCT02641392|OG002|Outcome|GED-0301 160 mg 4 Weeks Alt|"Participants received one of three dose regimens up to week 208:~1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks"
11261150|NCT02641392|EG000|Reported Event|GED-0301 40 mg 4 Weeks Alt|Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208
11261151|NCT02641392|EG001|Reported Event|GED-0301 40 mg|Participants received continuous GED-0301 40 mg daily, up to week 208.
11261152|NCT02641392|EG002|Reported Event|GED-0301 160 mg 4 Weeks Alt|"Participants received one of three dose regimens up to week 208:~1) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks"
11261153|NCT02641522|BG000|Baseline|Siltuximab|"Single infusion of siltuximab (11 mg/kg)~Siltuximab: Single infusion of siltuximab (11 mg/kg)"
11261154|NCT02641522|FG000|Participant Flow|Siltuximab|"Single infusion of siltuximab (11 mg/kg)~Siltuximab: Single infusion of siltuximab (11 mg/kg)"
11261155|NCT02641522|OG000|Outcome|Siltuximab|"Single infusion of siltuximab (11 mg/kg)~Siltuximab: Single infusion of siltuximab (11 mg/kg)"
11261156|NCT02641522|EG000|Reported Event|Siltuximab|"Single infusion of siltuximab (11 mg/kg)~Siltuximab: Single infusion of siltuximab (11 mg/kg)"
11261157|NCT02641561|BG000|Baseline|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
11261158|NCT02641561|BG001|Baseline|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
11261159|NCT02641561|BG002|Baseline|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
11261160|NCT02641561|BG003|Baseline|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
11261161|NCT02641561|BG004|Baseline|Total|Total of all reporting groups
11261162|NCT02641561|FG000|Participant Flow|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
11286688|NCT02891408|EG005|Reported Event|Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg|Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11286689|NCT02891408|EG006|Reported Event|Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg|Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
11261163|NCT02641561|FG001|Participant Flow|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
11261164|NCT02641561|FG002|Participant Flow|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
11261165|NCT02641561|FG003|Participant Flow|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
11261166|NCT02641561|OG000|Outcome|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
11261167|NCT02641561|OG001|Outcome|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
11261168|NCT02641561|OG002|Outcome|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
11261169|NCT02641561|OG003|Outcome|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
11261170|NCT02641561|EG000|Reported Event|A (NS+Placebo)|"Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.~Placebo: Placebo would be a suppository 50 mg x 2"
11261171|NCT02641561|EG001|Reported Event|B (NS+IND)|"Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride."
11261172|NCT02641561|EG002|Reported Event|C (LR+Placebo)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis~Placebo: Placebo would be a suppository 50 mg x 2"
11261173|NCT02641561|EG003|Reported Event|D (LR+IND)|"Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)~Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis~Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis"
11261174|NCT02641587|BG000|Baseline|CHTP 1.2|"Ad libitum use of the CHTP 1.2~CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting."
11261175|NCT02641587|BG001|Baseline|Cigarettes (CC)|"Ad libitum use of subject's own preferred non-menthol brand of CC~CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting."
11261176|NCT02641587|BG002|Baseline|Exposed Not Randomized|"Exposed not randomized refers to all subjects exposed to CHTP 1.2 but not randomized."
11261177|NCT02641587|BG003|Baseline|Total|Total of all reporting groups
11261178|NCT02641587|FG000|Participant Flow|CHTP 1.2|"Ad libitum use of the CHTP 1.2~CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting."
11261179|NCT02641587|FG001|Participant Flow|Cigarettes (CC)|"Ad libitum use of subject's own preferred non-menthol brand of CC~CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting."
11261180|NCT02641587|OG000|Outcome|CHTP 1.2|"Ad libitum use of the CHTP 1.2~CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting."
11261181|NCT02641587|OG001|Outcome|Cigarettes (CC)|"Ad libitum use of subject's own preferred non-menthol brand of CC~CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting."
11261182|NCT02641587|EG000|Reported Event|Product Test|After all inclusion/exclusion criteria were checked, all eligible subjects were enrolled and performed a product test using up to five CHTP 1.2
11261183|NCT02641587|EG001|Reported Event|CHTP 1.2 Confinement|Ad libitum use of the CHTP 1.2 for 5 days in confinement.
11261184|NCT02641587|EG002|Reported Event|CC Confinement|Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement.
11261185|NCT02641587|EG003|Reported Event|CHTP 1.2 Ambulatory|Ad libitum use of the CHTP 1.2 for 85 days in an ambulatory setting.
11261186|NCT02641587|EG004|Reported Event|CC Ambulatory|Ad libitum use of subject's own preferred non-menthol brand of CC for 85 days in an ambulatory setting.
11261187|NCT02641587|EG005|Reported Event|CHTP 1.2 Safety FU|CHTP 1.2 Safety Follow-Up period of 28 days
11261188|NCT02641587|EG006|Reported Event|CC Safety FU|CC Safety Follow-Up period of 28 days
11261189|NCT02641587|EG007|Reported Event|CHTP 1.2 Post-Randomization|CHTP 1.2 Post-Randomization period
11261190|NCT02641587|EG008|Reported Event|CC Post-Randomization|CC Post-Randomization period
11261191|NCT02641691|BG000|Baseline|Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU|"Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.~An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.~Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.~Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.~5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles~Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX"
11261192|NCT02641691|FG000|Participant Flow|Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU|"Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.~An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.~Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.~Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.~5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles~Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX"
11261193|NCT02641691|OG000|Outcome|Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU|"Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.~An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.~Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.~Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.~5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles~Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX"
11261194|NCT02641691|OG000|Outcome|0=Not at All|-Participant is asked about specific well-being in the past 7 days
11261195|NCT02641691|OG001|Outcome|1=A Little Bit|-Participant is asked about specific well-being in the past 7 days
11261196|NCT02641691|OG002|Outcome|2=Somewhat|-Participant is asked about specific well-being in the past 7 days
11261197|NCT02641691|OG003|Outcome|3=Quite a Bit|-Participant is asked about specific well-being in the past 7 days
11261198|NCT02641691|OG004|Outcome|4=Very Much|-Participant is asked about specific well-being in the past 7 days
11261199|NCT02641691|OG005|Outcome|Prefer Not to Answer/No Answer/No|-Participant did not answer question about well-being
11286690|NCT02891629|BG000|Baseline|Device Use in Healthy Volunteers|"10 healthy volunteers will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11286691|NCT02891629|BG001|Baseline|Device Use in ALS Patients|"5 ALS patients in early stages will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11286692|NCT02891629|BG002|Baseline|Total|Total of all reporting groups
11261200|NCT02641691|EG000|Reported Event|Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU|"Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.~An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.~Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.~Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.~5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.~5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles~Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX"
11261201|NCT02641730|BG000|Baseline|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo-controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
11261202|NCT02641730|BG001|Baseline|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
11261203|NCT02641730|BG002|Baseline|Guselkumab 200 mg|Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261204|NCT02641730|BG003|Baseline|Total|Total of all reporting groups
11261205|NCT02641730|FG000|Participant Flow|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo-controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
11261206|NCT02641730|FG001|Participant Flow|Placebo Then Guselkumab 100 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 100 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261207|NCT02641730|FG002|Participant Flow|Placebo Then Guselkumab 200 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 200 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261208|NCT02641730|FG003|Participant Flow|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
11261209|NCT02641730|FG004|Participant Flow|Guselkumab 200 mg|Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
10820336|NCT00056862|EG000|Reported Event|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
11261210|NCT02641730|OG000|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo-controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
11261211|NCT02641730|OG001|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
11261212|NCT02641730|OG002|Outcome|Guselkumab 200 mg|Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261213|NCT02641730|OG001|Outcome|Placebo Then Guselkumab 100 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 100 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261214|NCT02641730|OG002|Outcome|Placebo Then Guselkumab 200 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 200 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261215|NCT02641730|OG003|Outcome|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
11261216|NCT02641730|OG004|Outcome|Guselkumab 200 mg|Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261217|NCT02641730|EG000|Reported Event|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo-controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
11261218|NCT02641730|EG001|Reported Event|Placebo Then Guselkumab 100 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 100 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261219|NCT02641730|EG002|Reported Event|Placebo Then Guselkumab 200 mg|Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo-controlled period were crossed over to receive guselkumab 200 mg SC injection at Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261220|NCT02641730|EG003|Reported Event|Guselkumab 100 mg|Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
11261221|NCT02641730|EG004|Reported Event|Guselkumab 200 mg|Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
11261222|NCT02641834|BG000|Baseline|Veg Group|"Group that starts with the Vegetarian diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261223|NCT02641834|BG001|Baseline|Med Group|"Group that starts with the Mediterranean diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261224|NCT02641834|BG002|Baseline|Total|Total of all reporting groups
11261225|NCT02641834|FG000|Participant Flow|Veg Group|"Group that starts with the Vegetarian diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261226|NCT02641834|FG001|Participant Flow|Med Group|"Group that starts with the Mediterranean diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261227|NCT02641834|OG000|Outcome|Veg Group|"Group that starts with the Vegetarian diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261228|NCT02641834|OG001|Outcome|Med Group|"Group that starts with the Mediterranean diet~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months"
11261229|NCT02641834|OG001|Outcome|Med Group|"Group that starts with the Mediterranean diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261230|NCT02641834|EG000|Reported Event|Veg Group|"Group that starts with the Vegetarian diet~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months"
11261231|NCT02641834|EG001|Reported Event|Med Group|"Group that starts with the Mediterranean diet~Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months~Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months"
11261232|NCT02641912|BG000|Baseline|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
11261233|NCT02641912|BG001|Baseline|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
11261234|NCT02641912|BG002|Baseline|Total|Total of all reporting groups
11261235|NCT02641912|FG000|Participant Flow|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
11261236|NCT02641912|FG001|Participant Flow|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
11261237|NCT02641912|OG000|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
11261238|NCT02641912|OG001|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
11261239|NCT02641912|OG000|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
11261240|NCT02641912|OG001|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
11261241|NCT02641912|OG000|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
11261242|NCT02641912|OG001|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
11261243|NCT02641912|EG000|Reported Event|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
11261244|NCT02641912|EG001|Reported Event|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
11261245|NCT02642159|BG000|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
11261246|NCT02642159|BG001|Baseline|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
11261247|NCT02642159|BG002|Baseline|Total|Total of all reporting groups
11261248|NCT02642159|FG000|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapies (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels >=100 mg/dL (2.59 mmol/L) at Week 8.
11261249|NCT02642159|FG001|Participant Flow|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
11261250|NCT02642159|OG000|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
11261251|NCT02642159|OG001|Outcome|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
11261252|NCT02642159|OG001|Outcome|Usual Care: Intent to Prescribe Fenofibrate|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks.
11261253|NCT02642159|EG000|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8.
11261254|NCT02642159|EG001|Reported Event|Usual Care|Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
11261255|NCT02642237|BG000|Baseline|LPS-Fluenz|"Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~LPS"
11261256|NCT02642237|BG001|Baseline|Placebo-Fluenz|"Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~placebo"
11261257|NCT02642237|BG002|Baseline|Total|Total of all reporting groups
11261258|NCT02642237|FG000|Participant Flow|LPS-Fluenz|"Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~LPS"
11261259|NCT02642237|FG001|Participant Flow|Placebo-Fluenz|"Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~placebo"
11261260|NCT02642237|OG000|Outcome|LPS-Fluenz|"Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~LPS"
11261261|NCT02642237|OG001|Outcome|Placebo-Fluenz|"Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~placebo"
11261262|NCT02642237|EG000|Reported Event|LPS-Fluenz|"Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~LPS"
11261263|NCT02642237|EG001|Reported Event|Placebo-Fluenz|"Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin~Fluenz: intranasal inoculation with Fluenz~placebo"
11261264|NCT02642393|BG000|Baseline|Inosine|"Inosine will be dosed by titrating the number of capsules taken daily to achieve an elevation of serum urate to trough levels of 7.1 to 8.0 mg/dL.~Inosine: capsules containing 500 mg of inosine"
11261265|NCT02642393|BG001|Baseline|Placebo|"Placebo will be dosed to match the capsule titrations of the inosine group.~Placebo: capsules containing ~500 mg of lactose and appearing indistinguishable from inosine capsules"
11261266|NCT02642393|BG002|Baseline|Total|Total of all reporting groups
11261267|NCT02642393|FG000|Participant Flow|Inosine|"Inosine will be dosed by titrating the number of capsules taken daily to achieve an elevation of serum urate to trough levels of 7.1 to 8.0 mg/dL.~Inosine: capsules containing 500 mg of inosine"
11261268|NCT02642393|FG001|Participant Flow|Placebo|"Placebo will be dosed to match the capsule titrations of the inosine group.~Placebo: capsules containing ~500 mg of lactose and appearing indistinguishable from inosine capsules"
11261269|NCT02642393|OG000|Outcome|Inosine|"Inosine will be dosed by titrating the number of capsules taken daily to achieve an elevation of serum urate to trough levels of 7.1 to 8.0 mg/dL.~Inosine: capsules containing 500 mg of inosine"
11261270|NCT02642393|OG001|Outcome|Placebo|"Placebo will be dosed to match the capsule titrations of the inosine group.~Placebo: capsules containing ~500 mg of lactose and appearing indistinguishable from inosine capsules"
11261271|NCT02642393|EG000|Reported Event|Inosine|"Inosine will be dosed by titrating the number of capsules taken daily to achieve an elevation of serum urate to trough levels of 7.1 to 8.0 mg/dL.~Inosine: capsules containing 500 mg of inosine"
11261272|NCT02642393|EG001|Reported Event|Placebo|"Placebo will be dosed to match the capsule titrations of the inosine group.~Placebo: capsules containing ~500 mg of lactose and appearing indistinguishable from inosine capsules"
11261273|NCT02642432|BG000|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11261274|NCT02642432|FG000|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11261275|NCT02642432|OG000|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11261276|NCT02642432|EG000|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11261277|NCT02642536|BG000|Baseline|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
11261278|NCT02642536|BG001|Baseline|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
11261279|NCT02642536|BG002|Baseline|Total|Total of all reporting groups
11261280|NCT02642536|FG000|Participant Flow|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions"
11261281|NCT02642536|FG001|Participant Flow|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
11261282|NCT02642536|OG000|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
11261283|NCT02642536|OG001|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
11261284|NCT02642536|EG000|Reported Event|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions~MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
11261285|NCT02642536|EG001|Reported Event|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.~Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
11261286|NCT02642575|BG000|Baseline|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
11261287|NCT02642575|FG000|Participant Flow|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
11261288|NCT02642575|OG000|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
11261289|NCT02642575|EG000|Reported Event|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
11261290|NCT02642614|BG000|Baseline|Placebo|Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
11261291|NCT02642614|BG001|Baseline|5 Milligram BI 1026706|Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261292|NCT02642614|BG002|Baseline|25 Milligram BI 1026706|Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261293|NCT02642614|BG003|Baseline|100 Milligram BI 1026706|Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261294|NCT02642614|BG004|Baseline|Total|Total of all reporting groups
11261295|NCT02642614|FG000|Participant Flow|Placebo|Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
11261296|NCT02642614|FG001|Participant Flow|5 Milligram BI 1026706|Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261297|NCT02642614|FG002|Participant Flow|25 Milligram BI 1026706|Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261298|NCT02642614|FG003|Participant Flow|100 Milligram BI 1026706|Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261299|NCT02642614|OG000|Outcome|Placebo|Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
11261300|NCT02642614|OG001|Outcome|5 Milligram BI 1026706|Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261301|NCT02642614|OG002|Outcome|25 Milligram BI 1026706|Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261302|NCT02642614|OG003|Outcome|100 Milligram BI 1026706|Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261303|NCT02642614|OG000|Outcome|5 Milligram BI 1026706|Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261304|NCT02642614|OG001|Outcome|25 Milligram BI 1026706|Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11286693|NCT02891629|FG000|Participant Flow|Device Use in Healthy Volunteers|"10 healthy volunteers will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11261305|NCT02642614|OG002|Outcome|100 Milligram BI 1026706|Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261306|NCT02642614|EG000|Reported Event|Placebo|Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
11261307|NCT02642614|EG001|Reported Event|5 Milligram BI 1026706|Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261308|NCT02642614|EG002|Reported Event|25 Milligram BI 1026706|Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261309|NCT02642614|EG003|Reported Event|100 Milligram BI 1026706|Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
11261310|NCT02642627|BG000|Baseline|Bellafill Injections|"Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.~Bellafill"
11261311|NCT02642627|FG000|Participant Flow|Bellafill Injections|"Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.~Bellafill"
11261312|NCT02642627|OG000|Outcome|Bellafill Injections|"Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.~Bellafill"
11261313|NCT02642627|OG000|Outcome|Bellafill Injections|Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
11261314|NCT02642627|EG000|Reported Event|Bellafill Injections|Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
11261315|NCT02642653|BG000|Baseline|Lovastatin and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with study medication Lovastatin.~Lovastatin: Once per day dosing"
11261316|NCT02642653|BG001|Baseline|Placebo and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with placebo.~Placebo: Once per day dosing"
11261317|NCT02642653|BG002|Baseline|Total|Total of all reporting groups
11261318|NCT02642653|FG000|Participant Flow|Lovastatin and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with study medication Lovastatin.~Lovastatin: Once per day dosing"
11261319|NCT02642653|FG001|Participant Flow|Placebo and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with placebo.~Placebo: Once per day dosing"
11261320|NCT02642653|OG000|Outcome|Lovastatin and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with study medication Lovastatin.~Lovastatin: Once per day dosing"
11261321|NCT02642653|OG001|Outcome|Placebo and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with placebo.~Placebo: Once per day dosing"
11261322|NCT02642653|EG000|Reported Event|Lovastatin and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with study medication Lovastatin.~Lovastatin: Once per day dosing"
11261323|NCT02642653|EG001|Reported Event|Placebo and PILI|"Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with placebo.~Placebo: Once per day dosing"
11261324|NCT02642679|BG000|Baseline|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
11261325|NCT02642679|FG000|Participant Flow|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
11261326|NCT02642679|OG000|Outcome|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
11261327|NCT02642679|EG000|Reported Event|Opticell Ag|"Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.~Opticell Ag: Opticell Ag+ applied to STSG donor site"
11261328|NCT02642835|BG000|Baseline|Mesh Group|underwent anterior mesh for recurrent cystocele
11261329|NCT02642835|FG000|Participant Flow|Mesh Group|all had an anterior mesh for recurrent prolapse
11261330|NCT02642835|OG000|Outcome|Mesh Group|underwent anterior mesh for recurrent cystocele
11261331|NCT02642835|EG000|Reported Event|Mesh Group|underwent anterior mesh for recurrent cystocele
11261332|NCT02642952|BG000|Baseline|Open-graft Group|"Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261333|NCT02642952|BG001|Baseline|Endograft Group|"Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261334|NCT02642952|BG002|Baseline|Total|Total of all reporting groups
11261335|NCT02642952|FG000|Participant Flow|Open-graft Group|"Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261336|NCT02642952|FG001|Participant Flow|Endograft Group|"Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261337|NCT02642952|OG000|Outcome|Open-graft Group|"Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261338|NCT02642952|OG001|Outcome|Endograft Group|"Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261339|NCT02642952|EG000|Reported Event|Open-graft Group|"Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261340|NCT02642952|EG001|Reported Event|Endograft Group|"Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.~non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure."
11261341|NCT02642991|BG000|Baseline|Overall Study|Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week.
11261342|NCT02642991|FG000|Participant Flow|Phenacite Test Lens Then Comfilcon A Control Lens|"Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.~Phenacite: contact lens~comfilcon A: contact lens"
11261343|NCT02642991|FG001|Participant Flow|Comfilcon A Control Lens Then Phenacite Test Lens|"Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.~Phenacite: contact lens~comfilcon A: contact lens"
11261344|NCT02642991|OG000|Outcome|Phenacite Test Lens|"Participants were randomized to wear Phenacite test lens for one week~Phenacite: contact lens"
11261345|NCT02642991|OG001|Outcome|Comfilcon A Control Lens|"Participants were randomized to wear comfilcon A control lens for one week~comfilcon A: contact lens"
11261346|NCT02642991|OG000|Outcome|Overall Study|Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week.
11261347|NCT02642991|OG000|Outcome|Phenacite|"Subjects were randomized to wear phenacite study lens for one week.~Phenacite: contact lens"
11261348|NCT02642991|OG001|Outcome|Comfilcon A|"Subjects were randomized to wear comfilcon A contact lens for one week.~comfilcon A : contact lens"
11261349|NCT02642991|EG000|Reported Event|Phenacite Test Lens|"Participants were randomized to wear Phenacite test lens for one week.~Phenacite: contact lens"
11261350|NCT02642991|EG001|Reported Event|Comfilcon A Control Lens|"Participants were randomized to wear comfilcon A control lens for one week.~comfilcon A: contact lens"
11261351|NCT02643004|BG000|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
11261352|NCT02643004|FG000|Participant Flow|Senofilcon A, Then Stenfilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
11261353|NCT02643004|FG001|Participant Flow|Stenfilcon A, Then Senofilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens~Senofilcon A: contact lens"
11261354|NCT02643004|OG000|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
11261355|NCT02643004|OG001|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
11261356|NCT02643004|EG000|Reported Event|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
11261357|NCT02643004|EG001|Reported Event|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
11261358|NCT02643082|BG000|Baseline|Overall Study|All Randomized Patients
11261359|NCT02643082|FG000|Participant Flow|GFF MDI/Placebo MDI|Treatment Sequence of Glycopyrronium Formoterol Fumarate Metered Dose Inhalation/Placebo Metered Dose Inhalation
11261360|NCT02643082|FG001|Participant Flow|Placebo MDI/GFF MDI|Treatment Sequence of Placebo Metered Dose Inhalation/Glycopyrronium Formoterol Fumarate Metered Dose Inhalation
11261361|NCT02643082|OG000|Outcome|GFF MDI 14.4/9.6 µg|GFF MDI
11261362|NCT02643082|OG001|Outcome|Placebo MDI|Placebo
11261363|NCT02643082|EG000|Reported Event|Overall Study|All Randomized Patients
11261364|NCT02643082|EG001|Reported Event|GFF MDI 14.4/9.6 µg|GFF MDI
11261365|NCT02643082|EG002|Reported Event|Placebo MDI|Placebo
11261366|NCT02643095|BG000|Baseline|Lens Fitting/Evaluation|"This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.~scleral contact lens: Scleral contact lens"
11261367|NCT02643095|FG000|Participant Flow|Lens Fitting/Evaluation|"This study was conducted with subjects who already habitually wore scleral contact lenses. The study lens was made with a material that is already widely available and has a new design. It was fit by the investigators and assessed one week and 1 month of wear.~scleral contact lens: Scleral contact lens"
11261368|NCT02643095|OG000|Outcome|Lens Fitting/Evaluation|"This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.~scleral contact lens: Scleral contact lens"
11261369|NCT02643095|EG000|Reported Event|Lens Fitting/Evaluation|"This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.~scleral contact lens: Scleral contact lens"
11261370|NCT02643199|BG000|Baseline|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
11261371|NCT02643199|FG000|Participant Flow|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
11261372|NCT02643199|OG000|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
11261373|NCT02643199|EG000|Reported Event|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
11261374|NCT02643225|BG000|Baseline|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261375|NCT02643225|BG001|Baseline|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261376|NCT02643225|BG002|Baseline|Total|Total of all reporting groups
11261377|NCT02643225|FG000|Participant Flow|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
11261378|NCT02643225|FG001|Participant Flow|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
11261379|NCT02643225|OG000|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261380|NCT02643225|OG001|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261381|NCT02643225|OG000|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261382|NCT02643225|EG000|Reported Event|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261383|NCT02643225|EG001|Reported Event|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
11261384|NCT02643251|BG000|Baseline|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
11261385|NCT02643251|BG001|Baseline|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
11261386|NCT02643251|BG002|Baseline|Total|Total of all reporting groups
11261387|NCT02643251|FG000|Participant Flow|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
11261388|NCT02643251|FG001|Participant Flow|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
11261389|NCT02643251|OG000|Outcome|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
11261390|NCT02643251|OG001|Outcome|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
11261391|NCT02643251|EG000|Reported Event|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%~Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
11261392|NCT02643251|EG001|Reported Event|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator~Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
11261393|NCT02643355|BG000|Baseline|Olanzapine|Standard of Care Option 1 - Olanzapine
11261394|NCT02643355|BG001|Baseline|Standard of Care - Clonidine|Standard of Care Option 2 - Clonidine
11261395|NCT02643355|BG002|Baseline|Total|Total of all reporting groups
11261396|NCT02643355|FG000|Participant Flow|Olanzapine|Standard of Care Option 1 - Olanzapine
11261397|NCT02643355|FG001|Participant Flow|Clonidine|Standard of Care Option 2 - Clonidine
11261398|NCT02643355|OG000|Outcome|Olanzapine|Standard of Care Option 1 - Olanzapine
11261399|NCT02643355|OG001|Outcome|Clonidine|Standard of Care Option 2 - Clonidine
11261400|NCT02643355|EG000|Reported Event|Olanzapine|Standard of Care Option 1 - Olanzapine
11261401|NCT02643355|EG001|Reported Event|Clonidine|Standard of Care Option 2 - Clonidine
11261402|NCT02643394|BG000|Baseline|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
11261403|NCT02643394|BG001|Baseline|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
11261404|NCT02643394|BG002|Baseline|Total|Total of all reporting groups
11261405|NCT02643394|FG000|Participant Flow|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
11261406|NCT02643394|FG001|Participant Flow|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
11261407|NCT02643394|OG000|Outcome|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
11261408|NCT02643394|OG001|Outcome|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
11261409|NCT02643394|EG000|Reported Event|Oral Acetaminophen|"Oral Acetaminophen 1-hour before surgery~Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision"
11261410|NCT02643394|EG001|Reported Event|Intravenous Acetaminophen|"Intravenous Acetaminophen within 1-hour prior to anesthetic emergence~Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence."
11261411|NCT02643459|BG000|Baseline|Conventional|no suPAR measurement. Standard care.
11261412|NCT02643459|BG001|Baseline|suPAR|suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
11261413|NCT02643459|BG002|Baseline|Total|Total of all reporting groups
11261414|NCT02643459|FG000|Participant Flow|Conventional|no suPAR measurement. Standard care.
11261415|NCT02643459|FG001|Participant Flow|suPAR|suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
11261416|NCT02643459|OG000|Outcome|Conventional|no suPAR measurement. Standard care.
11261417|NCT02643459|OG001|Outcome|suPAR|suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
11261418|NCT02643459|OG001|Outcome|suPAR|"suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.~suPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge."
11261419|NCT02643459|EG000|Reported Event|Conventional|no suPAR measurement. Standard care.
11261420|NCT02643459|EG001|Reported Event|suPAR|suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
11261421|NCT02643472|BG000|Baseline|Care Notebook|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261422|NCT02643472|BG001|Baseline|Care Notebook + Parent Navigator|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.~Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261423|NCT02643472|BG002|Baseline|Total|Total of all reporting groups
11261424|NCT02643472|FG000|Participant Flow|Care Notebook|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261425|NCT02643472|FG001|Participant Flow|Care Notebook + Parent Navigator|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation (PN). Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.~Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261426|NCT02643472|OG000|Outcome|Care Notebook|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System."
11261427|NCT02643472|OG001|Outcome|Care Notebook + Parent Navigator|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.~Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and"
11261428|NCT02643472|OG000|Outcome|Care Notebook|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261429|NCT02643472|OG001|Outcome|Care Notebook + Parent Navigator|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.~Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261430|NCT02643472|EG000|Reported Event|Care Notebook|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261431|NCT02643472|EG001|Reported Event|Care Notebook + Parent Navigator|"Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.~Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ.~Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates."
11261432|NCT02643615|BG000|Baseline|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11261433|NCT02643615|BG001|Baseline|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
11261434|NCT02643615|BG002|Baseline|Total|Total of all reporting groups
11261435|NCT02643615|FG000|Participant Flow|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11286694|NCT02891629|FG001|Participant Flow|Device Use in ALS Patients|"5 ALS patients in early stages will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11261436|NCT02643615|FG001|Participant Flow|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11261437|NCT02643615|OG000|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11261438|NCT02643615|OG001|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
11261439|NCT02643615|OG001|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11261440|NCT02643615|EG000|Reported Event|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance~VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
11261441|NCT02643615|EG001|Reported Event|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia~VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.~Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
11261442|NCT02643628|BG000|Baseline|Microneedling Only|All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. Subjects randomized at week 12 to no further treatment.
11261443|NCT02643628|BG001|Baseline|Microneedling Followed by Bellafill Treatment|"Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.~Microneedling followed by Bellafill treatment"
11261444|NCT02643628|BG002|Baseline|Total|Total of all reporting groups
11261445|NCT02643628|FG000|Participant Flow|Microneedling Only|All subjects eligible scars within the treatment areas on each side of the face will receive microneedling treatment. At Week 12 subjects randomized to no further treatment.
11261446|NCT02643628|FG001|Participant Flow|Microneedling Followed by Bellafill Treatment|"All Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.~Microneedling followed by Bellafill treatment"
11261447|NCT02643628|OG000|Outcome|Microneedling Followed by Bellafill Treatment|"Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.~Microneedling followed by Bellafill treatment"
11261448|NCT02643628|OG001|Outcome|Microneedling Only|"All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.~Microneedling"
11261449|NCT02643628|OG000|Outcome|Microneedling Only|"All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.~Microneedling"
11261450|NCT02643628|OG001|Outcome|Microneedling Followed by Bellafill Treatment|"Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.~Microneedling followed by Bellafill treatment"
11261451|NCT02643628|EG000|Reported Event|Microneedling Followed by Bellafill Treatment|"Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.~Microneedling followed by Bellafill treatment"
11261452|NCT02643628|EG001|Reported Event|Microneedling Only|"All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.~Microneedling"
11261453|NCT02643693|BG000|Baseline|P3L/VUSE/CC Product Exposure|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261454|NCT02643693|FG000|Participant Flow|P3L/Vuse/CC Product Exposure|Subjects followed a sequence of product exposure comprised of P3L; VUSE; CC.
11261455|NCT02643693|FG001|Participant Flow|P3L/CC/Vuse Product Exposure|Subjects followed a sequence of product exposure comprised of P3L; CC; Vuse.
11261456|NCT02643693|FG002|Participant Flow|Vuse/CC/P3L Product Exposure|Subjects followed a sequence of product exposure comprised of Vuse; CC; P3L.
11261457|NCT02643693|FG003|Participant Flow|Vuse/P3L/CC Product Exposure|Subjects followed a sequence of product exposure comprised of Vuse; P3L; CC.
11261458|NCT02643693|FG004|Participant Flow|CC/P3L/Vuse Product Exposure|Subjects followed a sequence of product exposure comprised of CC; P3L; Vuse.
11261459|NCT02643693|FG005|Participant Flow|CC/Vuse/P3L Product Exposure|Subjects followed a sequence of product exposure comprised of the three products (CC; Vuse; P3L).
11261460|NCT02643693|OG000|Outcome|P3L Product Exposure|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261461|NCT02643693|OG001|Outcome|VUSE Product Exposure|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261462|NCT02643693|OG002|Outcome|CC Product Exposure|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261463|NCT02643693|EG000|Reported Event|P3L Product|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261464|NCT02643693|EG001|Reported Event|VUSE Product|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261465|NCT02643693|EG002|Reported Event|CC Product|Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
11261466|NCT02643849|BG000|Baseline|Spanner|The Spanner Temporary Prostatic Stent
11261467|NCT02643849|FG000|Participant Flow|Spanner|The Spanner Temporary Prostatic Stent
11261468|NCT02643849|OG000|Outcome|Spanner|The Spanner Temporary Prostatic Stent
11261469|NCT02643849|EG000|Reported Event|Spanner|The Spanner Temporary Prostatic Stent
11261470|NCT02643862|BG000|Baseline|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261471|NCT02643862|BG001|Baseline|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261472|NCT02643862|BG002|Baseline|Total|Total of all reporting groups
11261473|NCT02643862|FG000|Participant Flow|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261474|NCT02643862|FG001|Participant Flow|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261475|NCT02643862|OG000|Outcome|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261476|NCT02643862|OG001|Outcome|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261477|NCT02643862|EG000|Reported Event|Xolair|"Pts will be randomized to receive xolair at a 3 active:1 placebo ratio~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261478|NCT02643862|EG001|Reported Event|Placebo|"This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair~Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria"
11261479|NCT02643875|BG000|Baseline|Orthokeratology Lenses With Different Compression Factors|Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
11261480|NCT02643875|FG000|Participant Flow|Orthokeratology Lenses With Different Compression Factors|Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
11261481|NCT02643875|OG000|Outcome|Orthokeratology Lenses With Different Compression Factors|Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
11261482|NCT02643875|EG000|Reported Event|Conventional Compression Factor (0.75 D)|Orthokeratology lenses with conventional compression factor (0.75 D) were randomly assigned to one eye of each subject.
11261483|NCT02643875|EG001|Reported Event|Increased Compression Factor (1.75 D)|Orthokeratology lenses with increased compression factor (1.75 D) were randomly assigned to the fellow eye of each subject.
11261484|NCT02643979|BG000|Baseline|Ketofol: Ketamine and Propofol|This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
11261485|NCT02643979|BG001|Baseline|Propofol Only|This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
11261486|NCT02643979|BG002|Baseline|Total|Total of all reporting groups
11261487|NCT02643979|FG000|Participant Flow|Ketofol: Ketamine and Propofol|This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
11261488|NCT02643979|FG001|Participant Flow|Propofol Only|This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
11261489|NCT02643979|OG000|Outcome|Ketofol: Ketamine and Propofol|This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
11261490|NCT02643979|OG001|Outcome|Propofol Only|This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
11261491|NCT02643979|EG000|Reported Event|Ketofol and Propofol|This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
11261492|NCT02643979|EG001|Reported Event|Propofol Only|This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
11261493|NCT02644096|BG000|Baseline|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
11261494|NCT02644096|BG001|Baseline|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
11261495|NCT02644096|BG002|Baseline|Total|Total of all reporting groups
11261496|NCT02644096|FG000|Participant Flow|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
11261497|NCT02644096|FG001|Participant Flow|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
11261498|NCT02644096|OG000|Outcome|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
11261499|NCT02644096|OG001|Outcome|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation.after THR."
11261500|NCT02644096|EG000|Reported Event|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
11261501|NCT02644096|EG001|Reported Event|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR."
11261502|NCT02644109|BG000|Baseline|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261503|NCT02644109|BG001|Baseline|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261504|NCT02644109|BG002|Baseline|Total|Total of all reporting groups
11286695|NCT02891629|OG000|Outcome|Device Use in Healthy Volunteers|"10 healthy volunteers will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11286696|NCT02891629|OG001|Outcome|Device Use in ALS Patients|"5 ALS patients in early stages will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11261505|NCT02644109|FG000|Participant Flow|Phytosterols|"Milk powder: subjects will consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols).~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
11261506|NCT02644109|FG001|Participant Flow|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
11261507|NCT02644109|OG000|Outcome|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261508|NCT02644109|OG001|Outcome|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261509|NCT02644109|EG000|Reported Event|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261510|NCT02644109|EG001|Reported Event|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
11261511|NCT02644122|BG000|Baseline|SF1126|SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
11261512|NCT02644122|FG000|Participant Flow|SF1126|SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
11261513|NCT02644122|OG000|Outcome|SF1126|SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
11261514|NCT02644122|OG000|Outcome|SF1126|"SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.~SF1126"
11261515|NCT02644122|EG000|Reported Event|SF1126|"SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.~SF1126"
11261516|NCT02644278|BG000|Baseline|VX-984 120 mg + PLD 40 mg/m^2|Participants received VX-984 orally 120 milligram (mg) once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261517|NCT02644278|BG001|Baseline|VX-984 240 mg + PLD 40 mg/m^2|Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261518|NCT02644278|BG002|Baseline|VX-984 480 mg + PLD 40 mg/m^2|Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261519|NCT02644278|BG003|Baseline|VX-984 720 mg + PLD 40 mg/m^2|Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261520|NCT02644278|BG004|Baseline|Total|Total of all reporting groups
11261521|NCT02644278|FG000|Participant Flow|VX-984 120 mg + PLD 40 mg/m^2|Participants received VX-984 orally 120 milligram (mg) once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261522|NCT02644278|FG001|Participant Flow|VX-984 240 mg + PLD 40 mg/m^2|Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261523|NCT02644278|FG002|Participant Flow|VX-984 480 mg + PLD 40 mg/m^2|Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261524|NCT02644278|FG003|Participant Flow|VX-984 720 mg + PLD 40 mg/m^2|Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261525|NCT02644278|OG000|Outcome|VX-984 120 mg + PLD 40 mg/m^2|Participants received VX-984 orally 120 milligram (mg) once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261526|NCT02644278|OG001|Outcome|VX-984 240 mg + PLD 40 mg/m^2|Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261527|NCT02644278|OG002|Outcome|VX-984 480 mg + PLD 40 mg/m^2|Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261528|NCT02644278|OG003|Outcome|VX-984 720 mg + PLD 40 mg/m^2|Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261529|NCT02644278|EG000|Reported Event|VX-984 120 mg + PLD 40 mg/m^2|Participants received VX-984 orally 120 milligram (mg) once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261530|NCT02644278|EG001|Reported Event|VX-984 240 mg + PLD 40 mg/m^2|Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261531|NCT02644278|EG002|Reported Event|VX-984 480 mg + PLD 40 mg/m^2|Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261532|NCT02644278|EG003|Reported Event|VX-984 720 mg + PLD 40 mg/m^2|Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
11261533|NCT02644343|BG000|Baseline|Remote Programming Group|"Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.~The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.~Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants."
11261534|NCT02644343|FG000|Participant Flow|Remote Programming Group|"Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.~The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.~Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants."
11261535|NCT02644343|OG000|Outcome|Remote Programming Group|"Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.~The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.~Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants."
11261536|NCT02644343|EG000|Reported Event|Remote Programming Group|"Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.~The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.~Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants."
11261537|NCT02644356|BG000|Baseline|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
11261538|NCT02644356|FG000|Participant Flow|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
11261539|NCT02644356|OG000|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
11261540|NCT02644356|EG000|Reported Event|Online CE/CME Course|All subjects were assigned to take the three course modules of an online CE/CME course and complete pre- and post-course data collection. Module topics consisted of acupuncture, massage, and music-related interventions
11261541|NCT02644668|BG000|Baseline|Placebo|Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.
11261542|NCT02644668|BG001|Baseline|Reldesemtiv 150 mg Twice Daily|Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.
11261543|NCT02644668|BG002|Baseline|Reldesemtiv 450 mg Twice Daily|Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
11261544|NCT02644668|BG003|Baseline|Total|Total of all reporting groups
11261545|NCT02644668|FG000|Participant Flow|Placebo|"Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.~Placebo: Granules for oral suspension (placebo)"
11261546|NCT02644668|FG001|Participant Flow|Reldesemtiv 150 mg Twice Daily|"Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.~Reldesemtiv 150 mg: Granules for oral suspension, 18.7% reldesemtiv"
11261547|NCT02644668|FG002|Participant Flow|Reldesemtiv 450 mg Twice Daily|"Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.~Reldesemtiv 450 mg: Granules for oral suspension, 56.0% reldesemtiv"
11261548|NCT02644668|OG000|Outcome|Placebo|Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.
11261549|NCT02644668|OG001|Outcome|Reldesemtiv 150 mg Twice Daily|Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.
11261550|NCT02644668|OG002|Outcome|Reldesemtiv 450 mg Twice Daily|Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
11261551|NCT02644668|OG000|Outcome|Reldesemtiv 150 mg Twice Daily|Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.
11261552|NCT02644668|OG001|Outcome|Reldesemtiv 450 mg Twice Daily|Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
11261553|NCT02644668|EG000|Reported Event|Placebo|Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.
11261554|NCT02644668|EG001|Reported Event|Reldesemtiv 150 mg Twice Daily|Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.
11261555|NCT02644668|EG002|Reported Event|Reldesemtiv 450 mg Twice Daily|Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
11261556|NCT02645019|BG000|Baseline|LMA 2|Airway secured using a size 2 laryngeal mask airway.
11261557|NCT02645019|BG001|Baseline|LMA 2.5|Airway secured using a size 2.5 laryngeal mask airway.
11261558|NCT02645019|BG002|Baseline|LMA 3|Airway secured using a size 3 laryngeal mask airway.
11261559|NCT02645019|BG003|Baseline|LMA 4|Airway secured using a size 4 laryngeal mask airway.
11261560|NCT02645019|BG004|Baseline|Cuffed ETT|Airway secured using a cuffed endotracheal tube.
11261561|NCT02645019|BG005|Baseline|Total|Total of all reporting groups
11261562|NCT02645019|FG000|Participant Flow|Cuffed ETT|Airway secured using a cuffed endotracheal tube.
11261563|NCT02645019|FG001|Participant Flow|LMA 2|Airway secured using a size 2 laryngeal mask airway.
11261564|NCT02645019|FG002|Participant Flow|LMA 2.5|Airway secured using a size 2.5 laryngeal mask airway.
11261565|NCT02645019|FG003|Participant Flow|LMA 3|Airway secured using a size 3 laryngeal mask airway.
11261566|NCT02645019|FG004|Participant Flow|LMA 4|Airway secured using a size 4 laryngeal mask airway.
11261567|NCT02645019|OG000|Outcome|LMA 2|Airway secured using a size 2 laryngeal mask airway.
11261568|NCT02645019|OG001|Outcome|LMA 2.5|Airway secured using a size 2.5 laryngeal mask airway.
11261569|NCT02645019|OG002|Outcome|LMA 3|Airway secured using a size 3 laryngeal mask airway.
11261570|NCT02645019|OG003|Outcome|LMA 4|Airway secured using a size 4 laryngeal mask airway.
11261571|NCT02645019|OG004|Outcome|Cuffed ETT|Airway secured using a cuffed endotracheal tube.
11261572|NCT02645019|EG000|Reported Event|LMA 2|Airway secured using a size 2 laryngeal mask airway.
11261573|NCT02645019|EG001|Reported Event|LMA 2.5|Airway secured using a size 2.5 laryngeal mask airway.
11261574|NCT02645019|EG002|Reported Event|LMA 3|Airway secured using a size 3 laryngeal mask airway.
11261575|NCT02645019|EG003|Reported Event|LMA 4|Airway secured using a size 4 laryngeal mask airway.
11261576|NCT02645019|EG004|Reported Event|Cuffed ETT|Airway secured using a cuffed endotracheal tube.
11261577|NCT02645123|BG000|Baseline|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261578|NCT02645123|BG001|Baseline|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261579|NCT02645123|BG002|Baseline|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261580|NCT02645123|BG003|Baseline|Total|Total of all reporting groups
11261581|NCT02645123|FG000|Participant Flow|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
11261582|NCT02645123|FG001|Participant Flow|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
11261583|NCT02645123|FG002|Participant Flow|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
11261584|NCT02645123|OG000|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261585|NCT02645123|OG001|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261586|NCT02645123|OG002|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
11261587|NCT02645123|EG000|Reported Event|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
11261588|NCT02645123|EG001|Reported Event|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
11261589|NCT02645123|EG002|Reported Event|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
11261590|NCT02645253|BG000|Baseline|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
11261591|NCT02645253|BG001|Baseline|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
11261592|NCT02645253|BG002|Baseline|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
11261593|NCT02645253|BG003|Baseline|Palcebo|Participants received placebo
11261594|NCT02645253|BG004|Baseline|Total|Total of all reporting groups
11261595|NCT02645253|FG000|Participant Flow|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
11261596|NCT02645253|FG001|Participant Flow|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
11261597|NCT02645253|FG002|Participant Flow|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
11261598|NCT02645253|FG003|Participant Flow|Palcebo|Participants received placebo
11261599|NCT02645253|OG000|Outcome|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
11261600|NCT02645253|OG001|Outcome|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
11261601|NCT02645253|OG002|Outcome|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
11261602|NCT02645253|OG003|Outcome|Total AZD7594|Overall number of participants who received treatment with AZD7594.
11261603|NCT02645253|OG004|Outcome|Placebo|Participants who received placebo.
11261604|NCT02645253|OG005|Outcome|All Subjects|Total number of participants in the study.
11261605|NCT02645253|OG003|Outcome|Placebo|Participants received placebo.
11261606|NCT02645253|EG000|Reported Event|AZD7594 200 μg|Participants received 200 μg inhaled AZD7594 via multi-dose dry powder inhaler (DPI) (1 x 200 μg inhalation)
11261607|NCT02645253|EG001|Reported Event|AZD7594 400 μg|Participants received 400 μg inhaled AZD7594 via multi-dose DPI (1 x 400 μg inhalation)
10969954|NCT00908037|EG002|Reported Event|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
10969955|NCT00908037|EG003|Reported Event|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
10969956|NCT00908076|BG000|Baseline|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
10969957|NCT00908076|BG001|Baseline|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
10969958|NCT00908076|BG002|Baseline|Total|Total of all reporting groups
10969959|NCT00908076|FG000|Participant Flow|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
10969960|NCT00908076|FG001|Participant Flow|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
11261608|NCT02645253|EG002|Reported Event|AZD7594 1600 μg|Participants received 1600 μg inhaled AZD7594 via multi-dose DPI (4 x 400 μg inhalations).
11261609|NCT02645253|EG003|Reported Event|Palcebo|Participants received placebo
11261610|NCT02645253|EG004|Reported Event|Total AZD7594|Overall number of subjects who received AZD7594 therapy.
11261611|NCT02645253|EG005|Reported Event|All Subjects|Overall number of subjects who participated in the study.
11261612|NCT02645409|BG000|Baseline|Partial Nephrectomy|"OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.~OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.~Intraoperative fluorescence imaging system"
10969961|NCT00908076|OG000|Outcome|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
10969962|NCT00908076|OG001|Outcome|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
11261613|NCT02645409|BG001|Baseline|Radical Nephrectomy|"OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.~OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma."
10969963|NCT00908076|EG000|Reported Event|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
10969964|NCT00908076|EG001|Reported Event|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
11261614|NCT02645409|BG002|Baseline|Total|Total of all reporting groups
11286697|NCT02891629|EG000|Reported Event|Device Use in Healthy Volunteers|"10 healthy volunteers will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
10969965|NCT00908115|BG000|Baseline|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
10969966|NCT00908115|FG000|Participant Flow|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
10969967|NCT00908115|OG000|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
10969968|NCT00908115|EG000|Reported Event|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
10969969|NCT00908141|BG000|Baseline|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
11261615|NCT02645409|FG000|Participant Flow|Partial Nephrectomy|"OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.~OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.~Intraoperative fluorescence imaging system"
11261616|NCT02645409|FG001|Participant Flow|Radical Nephrectomy|OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
11261617|NCT02645409|OG000|Outcome|Partial Nephrectomy|"OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.~OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.~Intraoperative fluorescence imaging system"
11261618|NCT02645409|EG000|Reported Event|Partial Nephrectomy|"OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.~OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.~Intraoperative fluorescence imaging system"
11261619|NCT02645409|EG001|Reported Event|Radical Nephrectomy|"OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.~OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma"
11261620|NCT02645617|BG000|Baseline|Varnish|"Dental varnish containing povidone iodine and sodium fluoride~Varnish: Topical application to the teeth"
11261621|NCT02645617|FG000|Participant Flow|Varnish|"Dental varnish containing povidone iodine and sodium fluoride~Varnish: Topical application to the teeth"
11261622|NCT02645617|OG000|Outcome|Varnish|"Dental varnish containing povidone iodine and sodium fluoride~Varnish: Topical application to the teeth"
11261623|NCT02645617|EG000|Reported Event|Varnish|"Dental varnish containing povidone iodine and sodium fluoride~Varnish: Topical application to the teeth"
11261624|NCT02645760|BG000|Baseline|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
11261625|NCT02645760|BG001|Baseline|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
11261626|NCT02645760|BG002|Baseline|Total|Total of all reporting groups
11261627|NCT02645760|FG000|Participant Flow|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
11261628|NCT02645760|FG001|Participant Flow|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
11261629|NCT02645760|OG000|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
11261630|NCT02645760|OG001|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
11261631|NCT02645760|OG000|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
11261632|NCT02645760|EG000|Reported Event|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
11261633|NCT02645760|EG001|Reported Event|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
11261634|NCT02646124|BG000|Baseline|Diazepam|"Naproxen +Diazepam~Naproxen: Naproxen 500mg by mouth two times a day, #20~Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day,, #28"
11261635|NCT02646124|BG001|Baseline|Placebo|"Naproxen + Placebo~Naproxen: Naproxen 500mg by mouth two times a day, #20~Placebo: 28 placebo capsules"
11261636|NCT02646124|BG002|Baseline|Total|Total of all reporting groups
11261637|NCT02646124|FG000|Participant Flow|Diazepam|"Naproxen +Diazepam~Naproxen: Naproxen 500mg by mouth two times a day, #20~Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28"
11261638|NCT02646124|FG001|Participant Flow|Placebo|"Naproxen + Placebo~Naproxen: Naproxen 500mg by mouth two times a day, #20~Placebo: 28 placebo capsules"
11261639|NCT02646124|OG000|Outcome|Diazepam|"Naproxen +Diazepam~Naproxen: Naproxen 500mg by mouth two times a day, #20~Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28"
11261640|NCT02646124|OG001|Outcome|Placebo|"Naproxen + Placebo~Naproxen: Naproxen 500mg by mouth two times a day, #20~Placebo: 28 placebo capsules"
11261641|NCT02646124|EG000|Reported Event|Diazepam|"Naproxen +Diazepam~Naproxen: Naproxen 500mg by mouth two times a day, #20~Diazepam: Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28"
11261642|NCT02646124|EG001|Reported Event|Placebo|"Naproxen + Placebo~Naproxen: Naproxen 500mg by mouth two times a day, #20~Placebo: 28 placebo capsules"
11261643|NCT02646332|BG000|Baseline|(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)|"a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily~(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily"
11261644|NCT02646332|BG001|Baseline|Dexlan+Clarith+Amox+Metro|"dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days~dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days"
11261645|NCT02646332|BG002|Baseline|Total|Total of all reporting groups
11261646|NCT02646332|FG000|Participant Flow|(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)|"a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily~(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily"
11261647|NCT02646332|FG001|Participant Flow|Dexlan+Clarith+Amox+Metro|"dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days~dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days"
11261648|NCT02646332|OG000|Outcome|(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)|"a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily~(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily"
11261649|NCT02646332|OG001|Outcome|Dexlan+Clarith+Amox+Metro|"dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days~dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days"
11261650|NCT02646332|EG000|Reported Event|(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)|"a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily~(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily"
10969970|NCT00908141|BG001|Baseline|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
11261651|NCT02646332|EG001|Reported Event|Dexlan+Clarith+Amox+Metro|"dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days~dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days"
11261652|NCT02646371|BG000|Baseline|Flexyn2a - Vaccination|"2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart~Flexyn2a: 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart"
11261653|NCT02646371|BG001|Baseline|Placebo - Vaccination|"2 doses of TBS solution will be injected intramuscularly 4 weeks apart~Placebo: 2 doses of TBS solution will be injected intramuscularly 4 weeks apart"
11261654|NCT02646371|BG002|Baseline|Total|Total of all reporting groups
11261655|NCT02646371|FG000|Participant Flow|Flexyn2a - Vaccination|"2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart~Flexyn2a: 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart"
11261656|NCT02646371|FG001|Participant Flow|Placebo - Vaccination|"2 doses of TBS solution will be injected intramuscularly 4 weeks apart~Placebo: 2 doses of TBS solution will be injected intramuscularly 4 weeks apart"
11261657|NCT02646371|OG000|Outcome|Flexyn2a|The Flexyn2a treatment arm that was challenged.
11261658|NCT02646371|OG001|Outcome|Placebo|The control (Placebo) treatment arm that was challenged.
11261659|NCT02646371|EG000|Reported Event|Flexyn2a - Vaccination|In the Flexyn2a treatment arm - 34 subjects received the first Flexyn2a vaccine and 34 subjects received the second Flexyn2a vaccine.
11261660|NCT02646371|EG001|Reported Event|Placebo - Vaccination|In the control treatment (Placebo) arm - 34 subjects received the first Placebo vaccine and 30 subjects received the second Placebo vaccine.
11261661|NCT02646423|BG000|Baseline|Prior CD Decision App (PCDDA)|Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider.
11261662|NCT02646423|BG001|Baseline|Usual Care - No App|Women randomized to the Usual Care - No App group will simply continue with usual care.
11261663|NCT02646423|BG002|Baseline|Total|Total of all reporting groups
11261664|NCT02646423|FG000|Participant Flow|Prior CD Decision App (PCDDA)|Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider.
11261665|NCT02646423|FG001|Participant Flow|Usual Care - No App|Women randomized to the Usual Care - No App group will simply continue with usual care.
11261666|NCT02646423|OG000|Outcome|Prior CD Decision App (PCDDA)|Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider.
11261667|NCT02646423|OG001|Outcome|Usual Care - No App|Women randomized to the Usual Care - No App group will simply continue with usual care.
11261668|NCT02646423|EG000|Reported Event|Prior CD Decision App (PCDDA)|Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider.
11261669|NCT02646423|EG001|Reported Event|Usual Care - No App|Women randomized to the Usual Care - No App group will simply continue with usual care.
11261670|NCT02646449|BG000|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
11261671|NCT02646449|BG001|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11261672|NCT02646449|BG002|Baseline|Total|Total of all reporting groups
11261673|NCT02646449|FG000|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
11261674|NCT02646449|FG001|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11261675|NCT02646449|OG000|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
11261676|NCT02646449|OG001|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11261677|NCT02646449|EG000|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
11261678|NCT02646449|EG001|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
11261679|NCT02646566|BG000|Baseline|APD421 5mg|APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes
11261680|NCT02646566|BG001|Baseline|APD421 10mg|APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes
11261681|NCT02646566|BG002|Baseline|Placebo|Matching placebo administered as a single, slow, IV push over about two minutes
11261682|NCT02646566|BG003|Baseline|Total|Total of all reporting groups
11261683|NCT02646566|FG000|Participant Flow|APD421 5mg|APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes
11261684|NCT02646566|FG001|Participant Flow|APD421 10mg|APD421 10mg administered as a single,slow intravenous (IV) push over about two minutes
11261685|NCT02646566|FG002|Participant Flow|Placebo|Matching Placebo administered as a single, slow intravenous (IV) push over about two minutes
11261686|NCT02646566|OG000|Outcome|APD421 5mg|APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes
11261687|NCT02646566|OG001|Outcome|APD421 10mg|APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes
11261688|NCT02646566|OG002|Outcome|Placebo|Matching placebo administered as a single, slow, IV push over about two minutes
11261689|NCT02646566|EG000|Reported Event|APD421 IV 5mg|IV dose of APD421 5mg (IV dose)- was administered to each patient in a double-blind fashion, by slow IV push over about two minutes into a peripheral or central venous cannula.
11261690|NCT02646566|EG001|Reported Event|APD421 IV 10mg|IV dose of APD421 10mg (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula.
11261691|NCT02646566|EG002|Reported Event|Placebo|IV dose of Placebo (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula.
11261692|NCT02646618|BG000|Baseline|Get Social|"Get Social participants will receive a weight loss intervention in a protected Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Get Social: Online-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261693|NCT02646618|BG001|Baseline|Traditional|"Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Traditional: Group-delivered weight loss intervention"
11261694|NCT02646618|BG002|Baseline|Total|Total of all reporting groups
11261695|NCT02646618|FG000|Participant Flow|Get Social|"Get Social participants will receive a weight loss intervention in a protected Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Get Social: Online-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261696|NCT02646618|FG001|Participant Flow|Traditional|"Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Traditional: Group-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261697|NCT02646618|OG000|Outcome|Get Social|"Get Social participants will receive a weight loss intervention in a protected Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Get Social: Online-delivered weight loss intervention"
10969971|NCT00908141|BG002|Baseline|Total|Total of all reporting groups
11261698|NCT02646618|OG001|Outcome|Traditional|"Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Traditional: Group-delivered weight loss intervention"
11261699|NCT02646618|OG000|Outcome|Get Social|"Get Social participants will receive a weight loss intervention in a protected Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Get Social: Online-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261700|NCT02646618|OG001|Outcome|Traditional|"Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Traditional: Group-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261701|NCT02646618|EG000|Reported Event|Get Social|"Get Social participants will receive a weight loss intervention in a protected Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Get Social: Online-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261702|NCT02646618|EG001|Reported Event|Traditional|"Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.~Traditional: Group-delivered weight loss intervention~Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants"
11261703|NCT02646761|BG000|Baseline|Rehabilitation With InterACTION|"After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.~InterACTION: InterACTION guided home exercise program paired with standard of care physical therapy"
11261704|NCT02646761|BG001|Baseline|Standard Physical Therapy|"After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.~Standard of Care Physical Therapy: Physical therapy rehabilitation program"
11261705|NCT02646761|BG002|Baseline|Total|Total of all reporting groups
11261706|NCT02646761|FG000|Participant Flow|Rehabilitation With InterACTION|Subjects underwent a rehabilitation program with InterACTION.
11261707|NCT02646761|FG001|Participant Flow|Standard Physical Therapy|Subjects underwent standard of care physical therapy.
10969972|NCT00908141|FG000|Participant Flow|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
11261708|NCT02646761|OG000|Outcome|Rehabilitation With InterACTION|"After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.~InterACTION: InterACTION guided home exercise program paired with standard of care physical therapy"
11261709|NCT02646761|OG001|Outcome|Standard Physical Therapy|"After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.~Standard of Care Physical Therapy: Physical therapy rehabilitation program"
11261710|NCT02646761|EG000|Reported Event|Rehabilitation With InterACTION|"After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.~InterACTION: InterACTION guided home exercise program paired with standard of care physical therapy"
11261711|NCT02646761|EG001|Reported Event|Standard Physical Therapy|"After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.~Standard of Care Physical Therapy: Physical therapy rehabilitation program"
11261712|NCT02646826|BG000|Baseline|Placebo|"Subjects are treated with placebo tablets.~Placebo: Subjects are treated with Placebo tablets"
11261713|NCT02646826|BG001|Baseline|Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen|"Subjects are treated with the first dose level of Paxerol.~Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol"
11261714|NCT02646826|BG002|Baseline|Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen|"Subjects are treated with the second dose level of Paxerol.~Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol"
11261715|NCT02646826|BG003|Baseline|Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen|"Subjects are treated with the third dose level of Paxerol.~Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol"
11261716|NCT02646826|BG004|Baseline|Total|Total of all reporting groups
11261717|NCT02646826|FG000|Participant Flow|Placebo|"Subjects are treated with placebo tablets.~Placebo: Subjects are treated with Placebo tablets"
11261718|NCT02646826|FG001|Participant Flow|Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen|"Subjects are treated with the first dose level of Paxerol.~Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol"
11261719|NCT02646826|FG002|Participant Flow|Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen|"Subjects are treated with the second dose level of Paxerol.~Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol"
11261720|NCT02646826|FG003|Participant Flow|Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen|"Subjects are treated with the third dose level of Paxerol.~Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol"
11261721|NCT02646826|OG000|Outcome|Placebo|"Subjects are treated with placebo tablets.~Placebo: Subjects are treated with Placebo tablets"
11261722|NCT02646826|OG001|Outcome|Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen|"Subjects are treated with the first dose level of Paxerol.~Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol"
11261723|NCT02646826|OG002|Outcome|Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen|"Subjects are treated with the second dose level of Paxerol.~Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol"
11261724|NCT02646826|OG003|Outcome|Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen|"Subjects are treated with the third dose level of Paxerol.~Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol"
11261725|NCT02646826|EG000|Reported Event|Placebo|"Subjects are treated with placebo tablets.~Placebo: Subjects are treated with Placebo tablets"
11261726|NCT02646826|EG001|Reported Event|Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen|"Subjects are treated with the first dose level of Paxerol.~Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol"
11261727|NCT02646826|EG002|Reported Event|Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen|"Subjects are treated with the second dose level of Paxerol.~Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol"
11261728|NCT02646826|EG003|Reported Event|Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen|"Subjects are treated with the third dose level of Paxerol.~Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol"
11261729|NCT02646891|BG000|Baseline|Adults: Placebo|Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261730|NCT02646891|BG001|Baseline|Adults: 30 µg P2-VP8|Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261731|NCT02646891|BG002|Baseline|Adults: 90 µg P2-VP8|Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261732|NCT02646891|BG003|Baseline|Toddlers: Placebo|Toddlers received one intramuscular injection of placebo on Day 0.
11261733|NCT02646891|BG004|Baseline|Toddlers: 30 µg P2-VP8|Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261734|NCT02646891|BG005|Baseline|Toddlers: 90 µg P2-VP8|Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261735|NCT02646891|BG006|Baseline|Infants: Placebo|Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261736|NCT02646891|BG007|Baseline|Infants: 15 µg P2-VP8|Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261737|NCT02646891|BG008|Baseline|Infants: 30 µg P2-VP8|Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261738|NCT02646891|BG009|Baseline|Infants: 90 µg P2-VP8|Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261739|NCT02646891|BG010|Baseline|Total|Total of all reporting groups
11261740|NCT02646891|FG000|Participant Flow|Adult: Placebo|Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.
11261741|NCT02646891|FG001|Participant Flow|Adult: P2-VP8 (30 µg)|Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.
11261742|NCT02646891|FG002|Participant Flow|Adult: P2-VP8 (90 µg)|Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
11261743|NCT02646891|FG003|Participant Flow|Toddler: Placebo|Toddler participants who received one intramuscular injection of placebo on day 0. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.
11261744|NCT02646891|FG004|Participant Flow|Toddler: P2-VP8 (30 µg)|Toddler participants who received one intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) on day 0.
11261745|NCT02646891|FG005|Participant Flow|Toddler: P2-VP8 (90 µg)|Toddler participants who received one intramuscular injection of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) on day 0.
11261746|NCT02646891|FG006|Participant Flow|Infant: Placebo|Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.
11261747|NCT02646891|FG007|Participant Flow|Infant: P2-VP8 (15 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.
11261748|NCT02646891|FG008|Participant Flow|Infant: P2-VP8 (30 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.
11261749|NCT02646891|FG009|Participant Flow|Infant: P2-VP8 (90 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
11261750|NCT02646891|OG000|Outcome|Adults: Placebo|Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261751|NCT02646891|OG001|Outcome|Adults: 30 µg P2-VP8|Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261752|NCT02646891|OG002|Outcome|Adults: 90 µg P2-VP8|Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261753|NCT02646891|OG003|Outcome|Toddlers: Placebo|Toddlers received one intramuscular injection of placebo on Day 0.
11261754|NCT02646891|OG004|Outcome|Toddlers: 30 µg P2-VP8|Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261755|NCT02646891|OG005|Outcome|Toddlers: 90 µg P2-VP8|Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261756|NCT02646891|OG006|Outcome|Infants: Placebo|Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261757|NCT02646891|OG007|Outcome|Infants: 15 µg P2-VP8|Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261758|NCT02646891|OG008|Outcome|Infants: 30 µg P2-VP8|Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261759|NCT02646891|OG009|Outcome|Infants: 90 µg P2-VP8|Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261760|NCT02646891|OG000|Outcome|Infants: Placebo|Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261761|NCT02646891|OG001|Outcome|Infants: 15 µg P2-VP8|Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261762|NCT02646891|OG002|Outcome|Infants: 30 µg P2-VP8|Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261763|NCT02646891|OG003|Outcome|Infants: 90 µg P2-VP8|Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261764|NCT02646891|OG000|Outcome|Infants: Placebo|Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261765|NCT02646891|OG003|Outcome|Infants: Placebo|Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56.
11261766|NCT02646891|OG004|Outcome|Infants: 15 µg P2-VP8|Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261767|NCT02646891|OG005|Outcome|Infants: 30 µg P2-VP8|Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261768|NCT02646891|OG006|Outcome|Infants: 90 µg P2-VP8|Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56.
11261769|NCT02646891|OG000|Outcome|Toddlers: Placebo|Toddlers received one intramuscular injection of placebo on Day 0.
11261770|NCT02646891|OG001|Outcome|Toddlers: 30 µg P2-VP8|Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261771|NCT02646891|OG002|Outcome|Toddlers: 90 µg P2-VP8|Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0.
11261772|NCT02646891|EG000|Reported Event|Adult: Placebo|Adult participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.
11261773|NCT02646891|EG001|Reported Event|Adult: P2-VP8 (30 µg)|Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.
11261774|NCT02646891|EG002|Reported Event|Adult: P2-VP8 (90 µg)|Adult participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
11261775|NCT02646891|EG003|Reported Event|Toddler: Placebo|Toddler participants who received one intramuscular injection of placebo on day 0. Approximately half of the participants were compared to the arm receiving the 30 µg dose of P2-VP8; once the safety of this dose was established, the other half were compared to the arm receiving 90 µg.
11261776|NCT02646891|EG004|Reported Event|Toddler: P2-VP8 (30 µg)|Toddler participants who received one intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) on day 0.
11261777|NCT02646891|EG005|Reported Event|Toddler: P2-VP8 (90 µg)|Toddler participants who received one intramuscular injection of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) on day 0.
11261778|NCT02646891|EG006|Reported Event|Infant: Placebo|Infant participants who received three intramuscular injections of placebo four weeks apart on days 0, 28, and 56. Approximately one third of the participants were compared to the arm receiving the 15 µg dose of P2-VP8; once the safety of the 15 µg dose was established, one third of the participants were compared to the arm receiving 30 µg; and the last third were compared to the arm receiving 90 µg after the safety of the 30 µg dose was established.
11261779|NCT02646891|EG007|Reported Event|Infant: P2-VP8 (15 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (15 µg) four weeks apart on days 0, 28, and 56.
11261780|NCT02646891|EG008|Reported Event|Infant: P2-VP8 (30 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (30 µg) four weeks apart on days 0, 28, and 56.
11261781|NCT02646891|EG009|Reported Event|Infant: P2-VP8 (90 µg)|Infant participants who received three intramuscular injections of Trivalent P2-VP8 Subunit Rotavirus Vaccine (90 µg) four weeks apart on days 0, 28, and 56.
11261782|NCT02646917|BG000|Baseline|SkinPen II|"3 treatments with SkinPen II to each patient, each one month apart.~SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261783|NCT02646917|BG001|Baseline|SkinPen Precision|"3 treatments with SkinPen Precision to each patient, each one month apart.~SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261784|NCT02646917|BG002|Baseline|Total|Total of all reporting groups
11261785|NCT02646917|FG000|Participant Flow|SkinPen II|"21 Subjects, 3 SkinPen II treatments to each patient, each one month apart.~SkinPen II: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261786|NCT02646917|FG001|Participant Flow|SkinPen Precision|"20 Subjects, 3 SkinPen precision treatments to each patient, each one month apart.~SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261787|NCT02646917|OG000|Outcome|Skinpen ll|Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
11261788|NCT02646917|OG001|Outcome|Skinpen Precision|Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
11261789|NCT02646917|OG000|Outcome|SkinPen II|"21 Subjects, 3 SkinPen II treatments to each patient, each one month apart.~SkinPen II: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261790|NCT02646917|OG001|Outcome|SkinPen Precision|"20 Subjects, 3 SkinPen Precision treatments to each patient, each one month apart.~SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261791|NCT02646917|OG000|Outcome|SkinPen II|"Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.~Aesthetic Microneedling Treatment: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261792|NCT02646917|OG001|Outcome|SkinPen Precision|"Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.~Aesthetic Microneedling Treatment: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261793|NCT02646917|OG001|Outcome|SkinPen Precision|"20 Subjects, 3 SkinPen II treatments to each patient, each one month apart.~SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261794|NCT02646917|EG000|Reported Event|SkinPen II|"3 SkinPen ll treatments to each patient, each one month apart.~SkinPen ll: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261795|NCT02646917|EG001|Reported Event|SkinPen Precision|"3 SkinPen treatments to each patient, each one month apart.~SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring."
11261796|NCT02647203|BG000|Baseline|High Fluoride Toothpaste|"5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261797|NCT02647203|BG001|Baseline|Standard Fluoride Toothpaste|"1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261798|NCT02647203|BG002|Baseline|Total|Total of all reporting groups
11261799|NCT02647203|FG000|Participant Flow|High Fluoride Toothpaste|"5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261800|NCT02647203|FG001|Participant Flow|Standard Fluoride Toothpaste|"1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261801|NCT02647203|OG000|Outcome|High Fluoride Toothpaste|"5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261802|NCT02647203|OG001|Outcome|Standard Fluoride Toothpaste|"1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
10969973|NCT00908141|FG001|Participant Flow|Group B:Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
10969974|NCT00908141|OG000|Outcome|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
10969975|NCT00908141|OG001|Outcome|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
11261803|NCT02647203|EG000|Reported Event|High Fluoride Toothpaste|"5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11286698|NCT02891629|EG001|Reported Event|Device Use in ALS Patients|"5 ALS patients in early stages will be recruited~EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences"
11261804|NCT02647203|EG001|Reported Event|Standard Fluoride Toothpaste|"1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided."
11261805|NCT02647281|BG000|Baseline|Part 1: Placebo|Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.
11261806|NCT02647281|BG001|Baseline|Part 1: GSK3389404 10 mg|Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.
11261807|NCT02647281|BG002|Baseline|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.
11261808|NCT02647281|BG003|Baseline|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.
11261809|NCT02647281|BG004|Baseline|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
11261810|NCT02647281|BG005|Baseline|Part 2: Placebo|Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.
11261811|NCT02647281|BG006|Baseline|Part 2: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261812|NCT02647281|BG007|Baseline|Part 2: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261813|NCT02647281|BG008|Baseline|Part 2: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261814|NCT02647281|BG009|Baseline|Total|Total of all reporting groups
11261815|NCT02647281|FG000|Participant Flow|Part 1: Placebo|Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.
11261816|NCT02647281|FG001|Participant Flow|Part 1: GSK3389404 10 mg|Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.
11261817|NCT02647281|FG002|Participant Flow|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.
11261818|NCT02647281|FG003|Participant Flow|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.
11261819|NCT02647281|FG004|Participant Flow|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
11261820|NCT02647281|FG005|Participant Flow|Part 2: Placebo|Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.
11261821|NCT02647281|FG006|Participant Flow|Part 2: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261822|NCT02647281|FG007|Participant Flow|Part 2: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261823|NCT02647281|FG008|Participant Flow|Part 2: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261824|NCT02647281|OG000|Outcome|Part 1: Placebo|Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.
11261825|NCT02647281|OG001|Outcome|Part 1: GSK3389404 10 mg|Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.
11261826|NCT02647281|OG002|Outcome|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.
11261827|NCT02647281|OG003|Outcome|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.
11261828|NCT02647281|OG004|Outcome|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
11261829|NCT02647281|OG000|Outcome|Part 2: Placebo|Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.
11261830|NCT02647281|OG001|Outcome|Part 2: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261831|NCT02647281|OG002|Outcome|Part 2: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261832|NCT02647281|OG003|Outcome|Part 2: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261833|NCT02647281|OG000|Outcome|Part 1: GSK3389404 10 mg|Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.
11261834|NCT02647281|OG001|Outcome|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.
11261835|NCT02647281|OG002|Outcome|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.
11261836|NCT02647281|OG003|Outcome|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
11261837|NCT02647281|OG000|Outcome|Part 2: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261838|NCT02647281|OG001|Outcome|Part 2: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261839|NCT02647281|OG002|Outcome|Part 2: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261840|NCT02647281|OG000|Outcome|GSK3389404 10-120 mg|Participants received a single dose of either 10 mg or 30 mg or 60 mg or 120 mg of GSK3389404 by subcutaneous injection on Day 1 of Part 1 or Part 2.
11261841|NCT02647281|OG000|Outcome|GSK3389404 30-120 mg|Participants received a single dose of either 30 mg or 60 mg or 120 mg of GSK3389404 by subcutaneous injection QW for 4 weeks in Part 2.
11261842|NCT02647281|EG000|Reported Event|Part 1: Placebo|Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.
11261843|NCT02647281|EG001|Reported Event|Part 1: GSK3389404 10 mg|Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.
11261844|NCT02647281|EG002|Reported Event|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.
11261845|NCT02647281|EG003|Reported Event|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.
11261846|NCT02647281|EG004|Reported Event|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
11261847|NCT02647281|EG005|Reported Event|Part 2: Placebo|Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.
11261848|NCT02647281|EG006|Reported Event|Part 2: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261849|NCT02647281|EG007|Reported Event|Part 2: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261850|NCT02647281|EG008|Reported Event|Part 2: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
11261851|NCT02647320|BG000|Baseline|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
11261852|NCT02647320|BG001|Baseline|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
11261853|NCT02647320|BG002|Baseline|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
11261854|NCT02647320|BG003|Baseline|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
11261855|NCT02647320|BG004|Baseline|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
11261856|NCT02647320|BG005|Baseline|Total|Total of all reporting groups
11261857|NCT02647320|FG000|Participant Flow|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
11261858|NCT02647320|FG001|Participant Flow|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
11261859|NCT02647320|FG002|Participant Flow|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
11261860|NCT02647320|FG003|Participant Flow|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
11261861|NCT02647320|FG004|Participant Flow|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
11261862|NCT02647320|OG000|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablets and placebo
10969976|NCT00908141|EG000|Reported Event|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
10969977|NCT00908141|EG001|Reported Event|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
11261863|NCT02647320|OG001|Outcome|DS-8500a 50 mg|Two DS-8500a 25 mg tablets and placebo
11261864|NCT02647320|OG002|Outcome|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and placebo
11261865|NCT02647320|OG003|Outcome|Sitagliptin 100 mg|One sitagliptin 100 mg over-capsule and placebo
11261866|NCT02647320|OG004|Outcome|Placebo|Placebo tablets and capsule
11261867|NCT02647320|OG000|Outcome|DS-8500a 25mg|One DS-8500a 25 mg tablet and placebo
11261868|NCT02647320|OG004|Outcome|Placebo|Placebo tablets and placebo capsule
11261869|NCT02647320|EG000|Reported Event|DS-8500a 25mg|One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
11261870|NCT02647320|EG001|Reported Event|DS-8500a 50 mg|Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
11261871|NCT02647320|EG002|Reported Event|DS-8500a 75 mg|Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
11261872|NCT02647320|EG003|Reported Event|Sitagliptin 100 mg|Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
11261873|NCT02647320|EG004|Reported Event|Placebo|Three placebo tablets and one placebo capsule in a once-daily oral dose
11261874|NCT02647346|BG000|Baseline|Participant Cohort|Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
11261875|NCT02647346|FG000|Participant Flow|Participant Cohort|Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
11261876|NCT02647346|OG000|Outcome|Participant Cohort|Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
11261877|NCT02647346|EG000|Reported Event|Participant Cohort|Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
11261878|NCT02647645|BG000|Baseline|Cognitive Training|"Cognitive training Sham tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261879|NCT02647645|BG001|Baseline|Cognitive Training With tDCS|"Cognitive training Active tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261880|NCT02647645|BG002|Baseline|Total|Total of all reporting groups
11261881|NCT02647645|FG000|Participant Flow|Cognitive Training|"Cognitive training Sham tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261882|NCT02647645|FG001|Participant Flow|Cognitive Training With tDCS|"Cognitive training Active tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261883|NCT02647645|OG000|Outcome|Cognitive Training|"Cognitive training Sham tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261884|NCT02647645|OG001|Outcome|Cognitive Training With tDCS|"Cognitive training Active tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261885|NCT02647645|EG000|Reported Event|Cognitive Training|"Cognitive training Sham tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261886|NCT02647645|EG001|Reported Event|Cognitive Training With tDCS|"Cognitive training Active tDCS~Transcranial direct current stimulation: Direct current stimulation"
11261887|NCT02647658|BG000|Baseline|GBC+PIPT|"Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)~Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement"
11261888|NCT02647658|BG001|Baseline|Guideline Based Care|"Guideline Based Care (GBC)~Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives"
11261889|NCT02647658|BG002|Baseline|Total|Total of all reporting groups
11261890|NCT02647658|FG000|Participant Flow|GBC+PIPT|"Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)~Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement"
11261891|NCT02647658|FG001|Participant Flow|Guideline Based Care|"Guideline Based Care (GBC)~Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives"
11261892|NCT02647658|OG000|Outcome|GBC+PIPT|"Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)~Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement"
11261893|NCT02647658|OG001|Outcome|Guideline Based Care|"Guideline Based Care (GBC)~Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives"
11261894|NCT02647658|EG000|Reported Event|GBC+PIPT|"Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)~Guideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement"
11261895|NCT02647658|EG001|Reported Event|Guideline Based Care|"Guideline Based Care (GBC)~Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives"
11261896|NCT02647788|BG000|Baseline|Acetaminophen/Ibuprofen|"Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg~Acetaminophen/Ibuprofen: After surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit"
11261897|NCT02647788|BG001|Baseline|Acetaminophen/Codeine|"Group 2: Acetaminophen 300mg, Codeine 30 mg~Acetaminophen/Codeine: After surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit"
11261898|NCT02647788|BG002|Baseline|Total|Total of all reporting groups
11261899|NCT02647788|FG000|Participant Flow|Acetaminophen/Ibuprofen|"Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg~Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit"
11261900|NCT02647788|FG001|Participant Flow|Acetaminophen/Codeine|"Group 2: Acetaminophen 300mg, Codeine 30 mg~Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit"
11261901|NCT02647788|OG000|Outcome|Acetaminophen/Ibuprofen|"Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg~Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit"
11261902|NCT02647788|OG001|Outcome|Acetaminophen/Codeine|"Group 2: Acetaminophen 300mg, Codeine 30 mg~Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit"
11261903|NCT02647788|EG000|Reported Event|Acetaminophen/Ibuprofen|"Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg~Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit"
11261904|NCT02647788|EG001|Reported Event|Acetaminophen/Codeine|"Group 2: Acetaminophen 300mg, Codeine 30 mg~Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit"
11261905|NCT02647866|BG000|Baseline|KHK4083 Cohort 1|Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261906|NCT02647866|BG001|Baseline|KHK4083 Cohort 2|Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261907|NCT02647866|BG002|Baseline|KHK4083 Cohort 3|Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261908|NCT02647866|BG003|Baseline|KHK4083 Cohort 4|Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261909|NCT02647866|BG004|Baseline|Placebo|Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
11261910|NCT02647866|BG005|Baseline|Total|Total of all reporting groups
11261911|NCT02647866|FG000|Participant Flow|KHK4083 Cohort 1|Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261912|NCT02647866|FG001|Participant Flow|KHK4083 Cohort 2|Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261913|NCT02647866|FG002|Participant Flow|KHK4083 Cohort 3|Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261914|NCT02647866|FG003|Participant Flow|KHK4083 Cohort 4|Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261915|NCT02647866|FG004|Participant Flow|Placebo|Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
11261916|NCT02647866|OG000|Outcome|KHK4083 Cohort 1|Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261917|NCT02647866|OG001|Outcome|KHK4083 Cohort 2|Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261918|NCT02647866|OG002|Outcome|KHK4083 Cohort 3|Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261919|NCT02647866|OG003|Outcome|KHK4083 Cohort 4|Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261920|NCT02647866|OG004|Outcome|KHK4083 Combined|The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
11261921|NCT02647866|OG005|Outcome|Placebo|Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
11261922|NCT02647866|OG004|Outcome|KHK4083 Combined|The total number of participants analyzed who received KHK4083 during Induction Therapy.
11261923|NCT02647866|OG005|Outcome|Placebo|Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
11261924|NCT02647866|OG002|Outcome|KHK4083 Cohorts 3 + 4 Combined|Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
11261925|NCT02647866|OG003|Outcome|KHK4083 Combined|The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
11261926|NCT02647866|OG004|Outcome|Placebo|Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
11261927|NCT02647866|OG003|Outcome|KHK4083 Combined|The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy,
11261928|NCT02647866|EG000|Reported Event|KHK4083 Cohort 1|Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
11261929|NCT02647866|EG001|Reported Event|KHK4083 Cohort 2|Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
11261930|NCT02647866|EG002|Reported Event|KHK4083 Cohort 3|Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48.
11261931|NCT02647866|EG003|Reported Event|KHK4083 Cohort 4|Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48.
11261932|NCT02647866|EG004|Reported Event|KHK4083 Combined|The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A & B.
11261933|NCT02647866|EG005|Reported Event|Placebo|Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
11261934|NCT02647905|BG000|Baseline|Accuracy Assessment, CGMS|"To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days~Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device"
11261935|NCT02647905|FG000|Participant Flow|Accuracy Assessment, CGMS|"To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days~Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device"
11261936|NCT02647905|OG000|Outcome|Accuracy Assessment, CGMS|"To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days~Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device"
11261937|NCT02647905|EG000|Reported Event|Accuracy Assessment, CGMS|"To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days~Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device"
11261938|NCT02647944|BG000|Baseline|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261939|NCT02647944|BG001|Baseline|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261940|NCT02647944|BG002|Baseline|Total|Total of all reporting groups
11261941|NCT02647944|FG000|Participant Flow|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261942|NCT02647944|FG001|Participant Flow|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261943|NCT02647944|OG000|Outcome|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261944|NCT02647944|OG001|Outcome|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261945|NCT02647944|EG000|Reported Event|Liraglutide|Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261946|NCT02647944|EG001|Reported Event|Placebo|Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
11261947|NCT02648022|BG000|Baseline|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
11261948|NCT02648022|BG001|Baseline|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
11261949|NCT02648022|BG002|Baseline|Total|Total of all reporting groups
11261950|NCT02648022|FG000|Participant Flow|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
11261951|NCT02648022|FG001|Participant Flow|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
11261952|NCT02648022|OG000|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
11261953|NCT02648022|OG001|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
11261954|NCT02648022|EG000|Reported Event|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
11261955|NCT02648022|EG001|Reported Event|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
11261956|NCT02648178|BG000|Baseline|Ecigarette Use|Enrolled participants using the e-cigarette.
11261957|NCT02648178|FG000|Participant Flow|Ecigarette Use|Enrolled participants using the e-cigarette.
11261958|NCT02648178|OG000|Outcome|Ecigarette Use|Enrolled participants using the e-cigarette.
11261959|NCT02648178|EG000|Reported Event|Ecigarette Use|Enrolled participants using the e-cigarette.
11261960|NCT02648204|BG000|Baseline|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
11261961|NCT02648204|BG001|Baseline|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
11261962|NCT02648204|BG002|Baseline|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261963|NCT02648204|BG003|Baseline|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261964|NCT02648204|BG004|Baseline|Total|Total of all reporting groups
11261965|NCT02648204|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
11261966|NCT02648204|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period.
11261967|NCT02648204|FG002|Participant Flow|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261968|NCT02648204|FG003|Participant Flow|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261969|NCT02648204|OG000|Outcome|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
11261970|NCT02648204|OG001|Outcome|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
11261971|NCT02648204|OG002|Outcome|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261972|NCT02648204|OG003|Outcome|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261973|NCT02648204|EG000|Reported Event|Semaglutide 0.5 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).
11261974|NCT02648204|EG001|Reported Event|Semaglutide 1.0 mg|Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
11261975|NCT02648204|EG002|Reported Event|Dulaglutide 0.75 mg|Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11261976|NCT02648204|EG003|Reported Event|Dulaglutide 1.5 mg|Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
11337444|NCT03585504|OG001|Outcome|Control Group|"These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11337445|NCT03585504|EG000|Reported Event|Intervention Group|"Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11261977|NCT02648217|BG000|Baseline|Insulin Degludec/Insulin Aspart|Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
11261978|NCT02648217|BG001|Baseline|Biphasic Insulin Aspart 30|Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
11261979|NCT02648217|BG002|Baseline|Total|Total of all reporting groups
11261980|NCT02648217|FG000|Participant Flow|Insulin Degludec/Insulin Aspart|Subjects received insulin degludec/insulin aspart (IDegAsp) subcutaneously (s.c.; under the skin) in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered twice daily (BID) during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
11261981|NCT02648217|FG001|Participant Flow|Biphasic Insulin Aspart 30|Subjects received biphasic insulin aspart 30 (BIAsp 30) s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without oral antidiabetic drugs (OADs). Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' self-measured plasma glucose (SMPG) values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan
11261982|NCT02648217|OG000|Outcome|Insulin Degludec/Insulin Aspart|Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
11261983|NCT02648217|OG001|Outcome|Biphasic Insulin Aspart 30|Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
11261984|NCT02648217|EG000|Reported Event|Insulin Degludec/Insulin Aspart|Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
11286699|NCT02891681|BG000|Baseline|NIR/US (Neoadjuvant Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11261985|NCT02648217|EG001|Reported Event|Biphasic Insulin Aspart 30|Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
11261986|NCT02648230|BG000|Baseline|Pressure Wire and Microcatheter|"All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).~St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time~ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time"
11261987|NCT02648230|FG000|Participant Flow|Pressure Wire and Microcatheter|"All subjects enrolled will have both a fractional flow reserve (FFR) done measured by a pressure wire (PW) and then again by a microcatheter (MC).~St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time~ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time"
11261988|NCT02648230|OG000|Outcome|Pressure Wire and Microcatheter|"All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).~St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time~ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time"
11261989|NCT02648230|EG000|Reported Event|Pressure Wire and Microcatheter|"All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).~St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time~ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time"
11261990|NCT02648438|BG000|Baseline|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
11261991|NCT02648438|BG001|Baseline|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
11261992|NCT02648438|BG002|Baseline|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
11261993|NCT02648438|BG003|Baseline|Total|Total of all reporting groups
11261994|NCT02648438|FG000|Participant Flow|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
11261995|NCT02648438|FG001|Participant Flow|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
11261996|NCT02648438|FG002|Participant Flow|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
11261997|NCT02648438|OG000|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
11261998|NCT02648438|OG001|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
11261999|NCT02648438|OG002|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
11262000|NCT02648438|OG003|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
11262001|NCT02648438|OG000|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
11262002|NCT02648438|OG001|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
11262003|NCT02648438|OG004|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
11262004|NCT02648438|OG005|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
11262005|NCT02648438|EG000|Reported Event|IV Formulation|AZD7594 150 μg IV formulation
11262006|NCT02648438|EG001|Reported Event|DPI Device 1|AZD7594 400 μg delivered dose monodose inhaler
11262007|NCT02648438|EG002|Reported Event|DPI Device 2|AZD7594 400 μg delivered dose multiple-dose DPI
11262008|NCT02648438|EG003|Reported Event|pMDI|AZD7594 400 μg delivered dose pMDI
11262009|NCT02648438|EG004|Reported Event|Oral Formulation|AZD7594 1200 μg oral formulation
11262010|NCT02648438|EG005|Reported Event|pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (separate treatment)
11262011|NCT02648646|BG000|Baseline|Single Arm - Intervention|"Receives Otago Exercise Programme and Walk with Ease~Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program."
10969978|NCT00908232|BG000|Baseline|All Study Participants|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
11262012|NCT02648646|FG000|Participant Flow|Single Arm - Intervention|"Receives Otago Exercise Programme and Walk with Ease~Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program."
11337446|NCT03585504|EG001|Reported Event|Control Group|"These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.~Etonogestrel contraceptive implant: Etonogestrel contraceptive implant"
11337447|NCT03585543|BG000|Baseline|Intervention Group|This was a single-arm study; all participants received the intervention.
11262013|NCT02648646|OG000|Outcome|Single Arm - Intervention|"Receives Otago Exercise Programme and Walk with Ease~Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program."
11262014|NCT02648646|EG000|Reported Event|Single Arm - Intervention|"Receives Otago Exercise Programme and Walk with Ease~Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program."
11262015|NCT02648880|BG000|Baseline|Exercise Group|"Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.~Exercise program: Individual exercise sessions in this program implement a whole body approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.~Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team."
11262016|NCT02648880|FG000|Participant Flow|Exercise Group|"Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.~Exercise program: Individual exercise sessions in this program implement a whole body approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.~Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team."
11262017|NCT02648880|OG000|Outcome|Exercise Group|"Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.~Exercise program: Individual exercise sessions in this program implement a whole body approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.~Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team."
11262018|NCT02648880|EG000|Reported Event|Exercise Group|"Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.~Exercise program: Individual exercise sessions in this program implement a whole body approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.~Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team."
11262019|NCT02648919|BG000|Baseline|Noni 6,000 mg/Day|"Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)~Noni extract: Intervention will be administered on an outpatient basis. Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants."
11337448|NCT03585543|FG000|Participant Flow|Group Receiving mHealth Intervention|This was a single-arm study; all participants received the intervention.
11262020|NCT02648919|FG000|Participant Flow|Noni 6,000 mg/Day|"Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)~Noni extract: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants."
11262021|NCT02648919|OG000|Outcome|Noni 6,000 mg/Day|"Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)~Noni extract: Intervention will be administered on an outpatient basis. Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants."
11262022|NCT02648919|OG000|Outcome|Noni 6,000 mg/Day|"Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)~Noni extract: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants."
11262023|NCT02648919|EG000|Reported Event|Noni 6,000 mg/Day|"Noni extract 6,000 mg/day (4 capsules, 3 times per day)~Noni extract: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants."
11262024|NCT02648932|BG000|Baseline|Haplo-Cord Search|"If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.~Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device"
11262025|NCT02648932|BG001|Baseline|Matched Unrelated Donor Search (MUD)|"If subject meets the inclusion criteria and consents, will undergo a MUD transplant.~Matched Unrelated Donor Transplant"
11262026|NCT02648932|BG002|Baseline|Total|Total of all reporting groups
11262027|NCT02648932|FG000|Participant Flow|Haplo-Cord Search|"If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.~Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device"
11262028|NCT02648932|FG001|Participant Flow|Matched Unrelated Donor Search (MUD)|"If subject meets the inclusion criteria and consents, will undergo a MUD transplant.~Matched Unrelated Donor Transplant"
11262029|NCT02648932|OG000|Outcome|Haplo-Cord Search|"If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.~Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device"
11262030|NCT02648932|OG001|Outcome|Matched Unrelated Donor Search (MUD)|"If subject meets the inclusion criteria and consents, will undergo a MUD transplant.~Matched Unrelated Donor Transplant"
11262031|NCT02648932|EG000|Reported Event|Haplo-Cord Search|"If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.~Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device"
11262032|NCT02648932|EG001|Reported Event|Matched Unrelated Donor Search (MUD)|"If subject meets the inclusion criteria and consents, will undergo a MUD transplant.~Matched Unrelated Donor Transplant"
11262033|NCT02648971|BG000|Baseline|Single Portal Knee Arthroscopy|"After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Single Portal Knee Arthroscopy: Patients in Group 1 will undergo knee arthroscopy using a single portal."
11262034|NCT02648971|BG001|Baseline|Two Portal Knee Arthroscopy|"Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Two Portal Knee Arthroscopy: Patients in Group 2 will undergo knee arthroscopy using two portals."
11262035|NCT02648971|BG002|Baseline|Total|Total of all reporting groups
11262036|NCT02648971|FG000|Participant Flow|Single Portal Knee Arthroscopy|"After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Single Portal Knee Arthroscopy: Patients in Group 1 will undergo knee arthroscopy using a single portal."
11262037|NCT02648971|FG001|Participant Flow|Two Portal Knee Arthroscopy|"Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Two Portal Knee Arthroscopy: Patients in Group 2 will undergo knee arthroscopy using two portals."
11286700|NCT02891681|BG001|Baseline|NIR/US (Neoadjuvant Endocrine Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11262038|NCT02648971|OG000|Outcome|Single Portal Knee Arthroscopy|"After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Single Portal Knee Arthroscopy: Patients in Group 1 will undergo knee arthroscopy using a single portal."
11262039|NCT02648971|OG001|Outcome|Two Portal Knee Arthroscopy|"Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Two Portal Knee Arthroscopy: Patients in Group 2 will undergo knee arthroscopy using two portals."
11262040|NCT02648971|EG000|Reported Event|Single Portal Knee Arthroscopy|"After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Single Portal Knee Arthroscopy: Patients in Group 1 will undergo knee arthroscopy using a single portal."
11262041|NCT02648971|EG001|Reported Event|Two Portal Knee Arthroscopy|"Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.~Two Portal Knee Arthroscopy: Patients in Group 2 will undergo knee arthroscopy using two portals."
11262042|NCT02649192|BG000|Baseline|A&D-S1|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262043|NCT02649192|BG001|Baseline|Placebo - S1|Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
11262044|NCT02649192|BG002|Baseline|A&D - S2|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262045|NCT02649192|BG003|Baseline|Placebo - S2|Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
11262046|NCT02649192|BG004|Baseline|A&D - S3|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262047|NCT02649192|BG005|Baseline|Placebo - S3|Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
11262048|NCT02649192|BG006|Baseline|Total|Total of all reporting groups
11262049|NCT02649192|FG000|Participant Flow|A&D - S1|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262050|NCT02649192|FG001|Participant Flow|Placebo - S1|Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
11262051|NCT02649192|FG002|Participant Flow|A&D - S2|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262052|NCT02649192|FG003|Participant Flow|Placebo - S2|Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
11262053|NCT02649192|FG004|Participant Flow|A&D - S3|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262054|NCT02649192|FG005|Participant Flow|Placebo - S3|Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
11262055|NCT02649192|OG000|Outcome|A&D - S1|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262056|NCT02649192|OG001|Outcome|Placebo - S1|Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
11262057|NCT02649192|OG002|Outcome|A&D - S2|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262058|NCT02649192|OG003|Outcome|Placebo - S2|Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
11262059|NCT02649192|OG004|Outcome|A&D - S3|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262060|NCT02649192|OG005|Outcome|Placebo - S3|Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
11262061|NCT02649192|OG000|Outcome|A&D-S1|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262062|NCT02649192|OG000|Outcome|A&D-S1 VAS|Sub-group of subjects from the A&D-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262063|NCT02649192|OG001|Outcome|Placebo-S1 VAS|Sub-group of subjects from the Placebo-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
11262064|NCT02649192|OG002|Outcome|A&D-S2 VAS|Sub-group of subjects from the A&D-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262065|NCT02649192|OG003|Outcome|Placebo-S2 VAS|Sub-group of subjects from the Placebo-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
11262066|NCT02649192|OG004|Outcome|A&D-S3 VAS|Sub-group of subjects from the A&D-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262067|NCT02649192|OG005|Outcome|Placebo-S3 VAS|Sub-group of subjects from the Placebo-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
11337449|NCT03585543|OG000|Outcome|Intervention Group|This was a single-arm study; all participants received the intervention.
11262068|NCT02649192|OG006|Outcome|A&D-S1 Non-VAS|Sub-group of subjects from the A&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262069|NCT02649192|OG007|Outcome|Placebo-S1 Non-VAS|Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
11262070|NCT02649192|OG008|Outcome|A&D-S2 Non-VAS|Sub-group of subjects from the A&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262071|NCT02649192|OG009|Outcome|Placebo-S2 Non-VAS|Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
11262072|NCT02649192|OG010|Outcome|A&D-S3 Non-VAS|Sub-group of subjects from the A&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262073|NCT02649192|OG011|Outcome|Placebo-S3 Non-VAS|Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
11262074|NCT02649192|EG000|Reported Event|A&D-S1|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
11262075|NCT02649192|EG001|Reported Event|Placebo - S1|Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
11262076|NCT02649192|EG002|Reported Event|A&D - S2|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
11262077|NCT02649192|EG003|Reported Event|Placebo - S2|Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
11262078|NCT02649192|EG004|Reported Event|A&D - S3|Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
11262079|NCT02649192|EG005|Reported Event|Placebo - S3|Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
11262080|NCT02649218|BG000|Baseline|Ligelizumab|QGE031 240 mg s.c. q4w x 13 treatments
11262081|NCT02649218|FG000|Participant Flow|Ligelizumab|QGE031 240 mg s.c. q4w x 13 treatments
11262082|NCT02649218|OG000|Outcome|Ligelizumab|QGE031 240 mg s.c. q4w x 13 treatments
11262083|NCT02649218|EG000|Reported Event|QGE031 240 mg q4w (TEAE)|QGE031 240 mg every four weeks (TEAE)
11262084|NCT02649218|EG001|Reported Event|QGE031 240 mg q4w (Non-TEAE)|QGE031 240 mg every four weeks (non-TEAE)
11262085|NCT02649231|BG000|Baseline|Ketamine+Psychological Therapy|"Ketamine with psychological therapy~Ketamine: 0.8 mg/kg ketamine~Psychological Therapy: Manualised relapse prevention based CBT"
11262086|NCT02649231|BG001|Baseline|Ketamine+Education|"ketamine with alcohol education~Ketamine: 0.8 mg/kg ketamine~Alcohol Education: Simple education about alcohol effects"
11262087|NCT02649231|BG002|Baseline|Placebo+Psychological Therapy|"placebo with psychological therapy~Placebo: 0.9% saline~Psychological Therapy: Manualised relapse prevention based CBT"
11262088|NCT02649231|BG003|Baseline|Placebo+Education|"placebo with alcohol education~Placebo: 0.9% saline~Alcohol Education: Simple education about alcohol effects"
11262089|NCT02649231|BG004|Baseline|Total|Total of all reporting groups
10969979|NCT00908232|FG000|Participant Flow|Cycle 1 to 4: Bortezomib + Dexamethasone (VD)|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
11262090|NCT02649231|FG000|Participant Flow|Ketamine+Psychological Therapy|"Ketamine with psychological therapy~Ketamine: 0.8 mg/kg ketamine~Psychological Therapy: Manualised relapse prevention based CBT"
11262091|NCT02649231|FG001|Participant Flow|Ketamine+Education|"ketamine with alcohol education~Ketamine: 0.8 mg/kg ketamine~Alcohol Education: Simple education about alcohol effects"
11262092|NCT02649231|FG002|Participant Flow|Placebo+Psychological Therapy|"placebo with psychological therapy~Placebo: 0.9% saline~Psychological Therapy: Manualised relapse prevention based CBT"
11262093|NCT02649231|FG003|Participant Flow|Placebo+Education|"placebo with alcohol education~Placebo: 0.9% saline~Alcohol Education: Simple education about alcohol effects"
11262094|NCT02649231|OG000|Outcome|Ketamine+Psychological Therapy|"Ketamine with psychological therapy~Ketamine: 0.8 mg/kg ketamine~Psychological Therapy: Manualised relapse prevention based CBT"
11262095|NCT02649231|OG001|Outcome|Ketamine+Education|"ketamine with alcohol education~Ketamine: 0.8 mg/kg ketamine~Alcohol Education: Simple education about alcohol effects"
11262096|NCT02649231|OG002|Outcome|Placebo+Psychological Therapy|"placebo with psychological therapy~Placebo: 0.9% saline~Psychological Therapy: Manualised relapse prevention based CBT"
11262097|NCT02649231|OG003|Outcome|Placebo+Education|"placebo with alcohol education~Placebo: 0.9% saline~Alcohol Education: Simple education about alcohol effects"
11262098|NCT02649231|EG000|Reported Event|Ketamine+Psychological Therapy|"Ketamine with psychological therapy~Ketamine: 0.8 mg/kg ketamine~Psychological Therapy: Manualised relapse prevention based CBT"
11262099|NCT02649231|EG001|Reported Event|Ketamine+Education|"ketamine with alcohol education~Ketamine: 0.8 mg/kg ketamine~Alcohol Education: Simple education about alcohol effects"
11262100|NCT02649231|EG002|Reported Event|Placebo+Psychological Therapy|"placebo with psychological therapy~Placebo: 0.9% saline~Psychological Therapy: Manualised relapse prevention based CBT"
11262101|NCT02649231|EG003|Reported Event|Placebo+Education|"placebo with alcohol education~Placebo: 0.9% saline~Alcohol Education: Simple education about alcohol effects"
11262102|NCT02649322|BG000|Baseline|Group A Lidocaine J-Tip|"Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.~J-Tip: After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic pop and hissing sounds inherent to the J-tip injector."
11337450|NCT03585543|OG000|Outcome|Group Receiving mHealth Intervention|This was a single-arm study; all participants received the intervention.
11337451|NCT03585543|EG000|Reported Event|Intervention Group|This was a single-arm study; all participants received the intervention.
11262103|NCT02649322|BG001|Baseline|Group B Lidocaine Syringe|"Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.~Syringe and 25 gauge needle: The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle."
11262104|NCT02649322|BG002|Baseline|Total|Total of all reporting groups
11262105|NCT02649322|FG000|Participant Flow|Group A Lidocaine J-Tip|"Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.~J-Tip: After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic pop and hissing sounds inherent to the J-tip injector."
11262106|NCT02649322|FG001|Participant Flow|Group B Lidocaine Syringe|"Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.~Syringe and 25 gauge needle: The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle."
11262107|NCT02649322|OG000|Outcome|Group A Lidocaine J-Tip|"Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.~J-Tip: After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic pop and hissing sounds inherent to the J-tip injector."
11262108|NCT02649322|OG001|Outcome|Group B Lidocaine Syringe|"Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.~Syringe and 25 gauge needle: The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle."
11262109|NCT02649322|EG000|Reported Event|Group A|"Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure.~J-Tip: After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic pop and hissing sounds inherent to the J-tip injector."
11262110|NCT02649322|EG001|Reported Event|Group B|"Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure.~Syringe and 25 gauge needle: The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle."
11262111|NCT02649556|BG000|Baseline|THS 2.2 Use|"The THS 2.2 use product use category was defined as THS use of 70% or more over the entire analysis period.~(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)"
11262112|NCT02649556|BG001|Baseline|CC Use|"The CC use product use category was defined as THS use of less than 1% over the entire analysis period.~(≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)"
11262113|NCT02649556|BG002|Baseline|Dual Use|"The Dual use product use category was defined as THS use of less than 70% over the entire analysis period.~(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)"
11262114|NCT02649556|BG003|Baseline|Other Use|"Other use refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)"
11262115|NCT02649556|BG004|Baseline|Total|Total of all reporting groups
11262116|NCT02649556|FG000|Participant Flow|THS 2.2 Use|"This reporting group comprised 230 subjects. The THS 2.2 use product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)"
11262117|NCT02649556|FG001|Participant Flow|CC Use|"This reporting group comprised 424 subjects. The CC use product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)"
11262118|NCT02649556|FG002|Participant Flow|Dual Use|"This reporting group comprised 152 subjects. The Dual use product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)"
11262119|NCT02649556|FG003|Participant Flow|Other Use|"This reporting group comprised 51 subjects. Other use refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)"
11262120|NCT02649556|OG000|Outcome|THS 2.2 Use|"The THS 2.2 use product use category was defined as THS use of 70% or more over the entire analysis period.~(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)"
11337452|NCT03585712|BG000|Baseline|All Enrolled Subjects|All subjects enrolled in the study
11262121|NCT02649556|OG001|Outcome|CC Use|"The CC use product use category was defined as THS use of less than 1% over the entire analysis period.~(≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)"
11262122|NCT02649556|OG002|Outcome|Dual Use|"The Dual use product use category was defined as THS use of less than 70% over the entire analysis period.~(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)"
11262123|NCT02649556|OG003|Outcome|Other Use|"Other use refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)"
11262124|NCT02649556|EG000|Reported Event|THS 2.2 Use|"The THS 2.2 use product use category was defined as THS use of 70% or more over the entire analysis period.~(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)"
11262125|NCT02649556|EG001|Reported Event|CC Use|"The CC use product use category was defined as THS use of less than 1% over the entire analysis period.~(≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)"
11262126|NCT02649556|EG002|Reported Event|Dual Use|"The Dual use product use category was defined as THS use of less than 70% over the entire analysis period.~(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)~."
11262127|NCT02649556|EG003|Reported Event|Other Use|"Other use refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)"
11262128|NCT02649608|BG000|Baseline|Lu AE04621|Patients having received 3 or 4 doses of Lu AE04621, ranging from 0.04 to 1.2 mg. Baseline measures are anlayzed on full patient group only.
11262129|NCT02649608|FG000|Participant Flow|Group 1|Patients received 0.2 mg, 0.4 mg, and 0.6 mg Lu AE04621 on Days 1, 2, and 3, respectively
11262130|NCT02649608|FG001|Participant Flow|Group 2|Patient received 0.2 mg, 0.4 mg, and 0.2 mg Lu AE04621 on Days 1, 2, and 3, respectively
11262131|NCT02649608|FG002|Participant Flow|Group 3|Patients received 0.4 mg, 0.6 mg, and 0.8 mg Lu AE04621 on Days 1, 2, and 3, respectively
11262132|NCT02649608|FG003|Participant Flow|Group 4|Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.0 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
11262133|NCT02649608|FG004|Participant Flow|Group 5|Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.2 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
11262134|NCT02649608|FG005|Participant Flow|Group 6|Patients received 0.2 mg, 0.4 mg, 0.4 mg, and 0.4 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
11262135|NCT02649608|FG006|Participant Flow|Group 7|Patient received 0.04 mg, 0.08 mg, 0.6 mg, and 0.6 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
11262136|NCT02649608|OG000|Outcome|0.04 mg Lu AE04621|Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
11262137|NCT02649608|OG001|Outcome|0.08 mg Lu AE04621|Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
11262138|NCT02649608|OG002|Outcome|0.2 mg Lu AE04621|Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
11262139|NCT02649608|OG003|Outcome|0.4 mg Lu AE04621|Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
11262140|NCT02649608|OG004|Outcome|0.6 mg Lu AE04621|Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
11262141|NCT02649608|OG005|Outcome|0.8 mg Lu AE04621|Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
11262142|NCT02649608|OG006|Outcome|1.0 mg Lu AE04621|Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
11262143|NCT02649608|OG007|Outcome|1.2 mg Lu AE04621|Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
11262144|NCT02649608|OG000|Outcome|0.2 mg Lu AE04621|Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
11262145|NCT02649608|OG001|Outcome|0.4 mg Lu AE04621|Patients having received a dose of 0.4 mg Lu AE04621, independent of which cohort they belong to.
11262146|NCT02649608|OG002|Outcome|0.6 mg Lu AE04621|Patients having received a dose of 0.6 mg Lu AE04621, independent of which cohort they belong to.
11262147|NCT02649608|OG001|Outcome|0.08 mg LuAE04621|Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
11262148|NCT02649608|OG003|Outcome|0.4 mg Lu AE04621|Patients having received a dose of 0.4 mg, independent of which Cohort they belong to.
11262149|NCT02649608|OG004|Outcome|0.6 mg Lu AE06421|Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
11262150|NCT02649608|OG001|Outcome|0.4 mg Lu AE04621|Patients having received a dose of 0.4 mg, independent of which Cohort they belong to.
11262151|NCT02649608|OG002|Outcome|0.6 mg Lu AE04621|Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
11262152|NCT02649608|OG003|Outcome|0.8 mg Lu AE04621|Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
11262153|NCT02649608|OG004|Outcome|1.2 mg Lu AE04621|Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
11262154|NCT02649608|OG002|Outcome|0.6 mg Lu AE06421|Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
11262155|NCT02649608|EG000|Reported Event|0.04 mg Lu AE04621|
11262156|NCT02649608|EG001|Reported Event|0.08 mg Lu AE04621|
11262157|NCT02649608|EG002|Reported Event|0.2 mg Lu AE04621|
11262158|NCT02649608|EG003|Reported Event|0.4 mg Lu AE04621|
11262159|NCT02649608|EG004|Reported Event|0.6 mg Lu AE04621|
11262160|NCT02649608|EG005|Reported Event|0.8 mg Lu AE04621|
11262161|NCT02649608|EG006|Reported Event|1 mg Lu AE04621|
11262162|NCT02649608|EG007|Reported Event|1.2 mg Lu AE04621|
11337453|NCT03585712|FG000|Participant Flow|Treatment Period 1: All Enrolled Subjects|"Subjects were enrolled in treatment period 1 without being assigned an arm (Arm A or Arm B) until week 5.~Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3"
11262163|NCT02649634|BG000|Baseline|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
11262164|NCT02649634|BG001|Baseline|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
11262165|NCT02649634|BG002|Baseline|Total|Total of all reporting groups
11262166|NCT02649634|FG000|Participant Flow|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
11262167|NCT02649634|FG001|Participant Flow|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
11262168|NCT02649634|OG000|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
11262169|NCT02649634|OG001|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
11262170|NCT02649634|EG000|Reported Event|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
11262171|NCT02649634|EG001|Reported Event|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
11262172|NCT02649842|BG000|Baseline|Extended Cylinder IOL|All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
11262173|NCT02649842|FG000|Participant Flow|Extended Cylinder IOL|All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
11262174|NCT02649842|OG000|Outcome|Extended Cylinder IOL|All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
11262175|NCT02649842|OG000|Outcome|Extended Cylinder IOL|All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600)
11262176|NCT02649842|OG000|Outcome|Extended Cylinder IOL|All subjects implanted with a ZCT450/525/600 in at least one eye
11262177|NCT02649842|EG000|Reported Event|Extended Cylinder IOL|All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. Subject is considered to have adverse events whether the adverse event was in the higher cylinder or lower cylinder group.
11262178|NCT02649894|BG000|Baseline|Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)|"Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)~Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)"
11262179|NCT02649894|BG001|Baseline|Approved Uncoated PleurX Indwelling Pleural Catheter|"Approved Uncoated PleurX Indwelling Pleural Catheter~Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter"
11262180|NCT02649894|BG002|Baseline|Total|Total of all reporting groups
11262181|NCT02649894|FG000|Participant Flow|Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)|"Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)~Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)"
11262182|NCT02649894|FG001|Participant Flow|Approved Uncoated PleurX Indwelling Pleural Catheter|"Approved Uncoated PleurX Indwelling Pleural Catheter~Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter"
11262183|NCT02649894|OG000|Outcome|Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)|"Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)~Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)"
11262184|NCT02649894|OG001|Outcome|Approved Uncoated PleurX Indwelling Pleural Catheter|"Approved Uncoated PleurX Indwelling Pleural Catheter~Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter"
11262185|NCT02649894|EG000|Reported Event|Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)|"Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)~Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)"
11262186|NCT02649894|EG001|Reported Event|Approved Uncoated PleurX Indwelling Pleural Catheter|"Approved Uncoated PleurX Indwelling Pleural Catheter~Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter"
11262187|NCT02650128|BG000|Baseline|Shockwave Coronary Rx Lithoplasty System|"Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement~Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator."
11262188|NCT02650128|FG000|Participant Flow|Shockwave Coronary Rx Lithoplasty System|"Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement~Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator."
11262189|NCT02650128|OG000|Outcome|Shockwave Coronary Rx Lithoplasty System|"Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement~Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator."
11262190|NCT02650128|OG000|Outcome|Lithoplasty System|"Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement~Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator."
11262191|NCT02650128|EG000|Reported Event|Shockwave Coronary Rx Lithoplasty System|"Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement~Shockwave Coronary Rx Lithoplasty® System: The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator."
10969980|NCT00908232|FG001|Participant Flow|Stable Disease: Bortezomib + Dexamethasone (VD)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
10969981|NCT00908232|FG002|Participant Flow|SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
10969982|NCT00908232|FG003|Participant Flow|SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
11262192|NCT02650193|BG000|Baseline|Cycle 0: HSP-130 3mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262193|NCT02650193|BG001|Baseline|Cycles 0: HSP-130 6mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262194|NCT02650193|BG002|Baseline|Cycles 1-4: HSP-130 6mg|Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
11262195|NCT02650193|BG003|Baseline|Total|Total of all reporting groups
11262196|NCT02650193|FG000|Participant Flow|Cycle 0: HSP-130 3mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262197|NCT02650193|FG001|Participant Flow|Cycles 0: HSP-130 6mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262198|NCT02650193|FG002|Participant Flow|Cycles 1-4: HSP-130 6mg|Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
11262199|NCT02650193|OG000|Outcome|Cycle 0: HSP-130 3mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262200|NCT02650193|OG001|Outcome|Cycles 0: HSP-130 6mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262201|NCT02650193|OG000|Outcome|Cycles 1-4: HSP-130 6mg|Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
11262202|NCT02650193|OG002|Outcome|Cycles 1-4: HSP-130 6mg|Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
11262203|NCT02650193|EG000|Reported Event|Cycle 0: HSP-130 3mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262204|NCT02650193|EG001|Reported Event|Cycle 0: HSP-130 6mg|Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
11262205|NCT02650193|EG002|Reported Event|Cycle 1-4: HSP-130 6mg|Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
11262206|NCT02650219|BG000|Baseline|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
11262207|NCT02650219|BG001|Baseline|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
11262208|NCT02650219|BG002|Baseline|Total|Total of all reporting groups
11262209|NCT02650219|FG000|Participant Flow|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
10969983|NCT00908232|OG000|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
11262210|NCT02650219|FG001|Participant Flow|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
11262211|NCT02650219|OG000|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
11262212|NCT02650219|OG001|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
11262213|NCT02650219|EG000|Reported Event|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
10969984|NCT00908232|OG001|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
10969985|NCT00908232|EG000|Reported Event|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
11262214|NCT02650219|EG001|Reported Event|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
11262215|NCT02650440|BG000|Baseline|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
11262216|NCT02650440|BG001|Baseline|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
11262217|NCT02650440|BG002|Baseline|Total|Total of all reporting groups
11262218|NCT02650440|FG000|Participant Flow|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
11262219|NCT02650440|FG001|Participant Flow|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
11262220|NCT02650440|OG000|Outcome|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
11262221|NCT02650440|OG001|Outcome|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
11262222|NCT02650440|EG000|Reported Event|Novel Protocol|"Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.~Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject."
10820337|NCT00056862|EG001|Reported Event|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
10969986|NCT00908232|EG001|Reported Event|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
11262223|NCT02650440|EG001|Reported Event|Standard Protocol|"Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.~Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject"
11262224|NCT02650466|BG000|Baseline|Nanopulse Treatment|"The Nanopulse System consists of an electrical pulse generator, a handpiece, and a detachable applicator tip at the end of the handpiece that interfaces with the treatment area on the skin. The applicator tip delivers pulses to the skin through needle electrodes. The Applicator Tips are designed for single patient use, and are sterilized prior to first use and between treatment sessions using a standard steam autoclave.~All subjects will receive a minimum number of applications per discrete skin wart lesion (n=1 application). Up to 4 warts per subject will be treated. The wart will be debulked prior to the initial application. The subject will return after 1 week for an evaluation visit, at 4 weeks for a second treatment and up to 2 additional monthly treatments. Subjects will be evaluated at each application visit and placed in follow-up when they are declared clinically clear. They will return at the 12 week point post last visit for final assessment and evaluation."
11262225|NCT02650466|FG000|Participant Flow|Nanopulse Treatment|"The study will be a single center, open label, non-randomized clinical trial that will provide efficacy data for the treatment of common warts by the Nanopulse system in terms of efficacy and cosmetic outcome with 1 - 4 application (treatment) sessions. All subjects will receive a minimum number of applications (n=1 application) per discrete skin wart lesion. Up to 4 warts per subject will be treated with the Nanopulse device. The wart will be debulked to the point of pinpoint bleeding prior to the initial application. The subject will return after 1 week for an evaluation visit and at 4 weeks for a second treatment and 2 additional monthly treatments if warranted. If the subject is declared clinically clear at any of the application visits, they will be placed into follow up. They will return at the 12 week point post last visit for final assessment and evaluation.~Nanopulse System: The Nanopulse System consists of an electrical"
11262226|NCT02650466|OG000|Outcome|Partially Removed(1)|wart size has been reduced in height and width during treatment.
11262227|NCT02650466|OG000|Outcome|Number of Adverse Events|"An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.~For those anticipated adverse reactions which are not present before the first application procedure and are rated at a severity level above minimal or mild will be recorded at the time of occurrence. The adverse event will be reported to the sponsor, and will be followed by study personnel through to its resolution. All unanticipated adverse reactions, regardless of their severity, will be recorded as adverse events and reported to the sponsor."
11262228|NCT02650466|OG000|Outcome|Number of Serious Adverse Events|
11262229|NCT02650466|EG000|Reported Event|Nanopulse Treatment|
10969987|NCT00908310|BG000|Baseline|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
10969988|NCT00908310|FG000|Participant Flow|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
10969989|NCT00908310|OG000|Outcome|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
10969990|NCT00908310|EG000|Reported Event|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
10969991|NCT00908349|BG000|Baseline|Oxcarbazepine XR|"Open Label Study~Oxcarbazepine XR: Open Label Study"
10969992|NCT00908349|FG000|Participant Flow|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
10969993|NCT00908349|OG000|Outcome|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
10969994|NCT00908349|EG000|Reported Event|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
10969995|NCT00908375|BG000|Baseline|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
10969996|NCT00908375|BG001|Baseline|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
10969997|NCT00908375|BG002|Baseline|Total|Total of all reporting groups
10969998|NCT00908375|FG000|Participant Flow|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
10969999|NCT00908375|FG001|Participant Flow|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
11262230|NCT02650856|BG000|Baseline|Group 1 Tranexamic Acid|"A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.~First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.~Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.~Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site."
11262231|NCT02650856|BG001|Baseline|Group 2 Platelet Rich Plasma|"A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.~First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.~Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.~Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site"
11262232|NCT02650856|BG002|Baseline|Total|Total of all reporting groups
11262233|NCT02650856|FG000|Participant Flow|Group 1 Tranexamic Acid|"A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.~First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.~Second application: The rest of 40ml of solution previously prepared is applied after placing the final total knee replacement components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.~Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site."
11262234|NCT02650856|FG001|Participant Flow|Group 2 Platelet Rich Plasma|"A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.~First application: 8 mL of Platelet rich plasma are applied over the surgical site and are left for five minutes then drained out completely by suction.~Second application: The rest of the 8 mL are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.~Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site"
11262235|NCT02650856|OG000|Outcome|Group 1 Tranexamic Acid|"A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.~First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.~Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.~Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site."
11262236|NCT02650856|OG001|Outcome|Group 2 Platelet Rich Plasma|"A final volume of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.~First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.~Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.~Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site"
11262237|NCT02650856|EG000|Reported Event|Group 1 Tranexamic Acid|"A dosis of 2 gr of tranexamic acid (1000mg/10mL X-GEN pharmaceuticals inc.) diluted in 80mL of physiologic solution and will be divided in two applications.~First application: 40mL of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.~Second application: The rest of 40mL of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.~Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site."
11262238|NCT02650856|EG001|Reported Event|Group 2 Platelet Rich Plasma|"A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.~First application: 8 mL of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.~Second application: The rest of the 8 mL are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.~Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site"
11262239|NCT02650895|BG000|Baseline|Saline|Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
11262240|NCT02650895|BG001|Baseline|CD24Fc 10 mg|Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262241|NCT02650895|BG002|Baseline|CD24Fc 30 mg|Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262242|NCT02650895|BG003|Baseline|CD24Fc 60 mg|Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262243|NCT02650895|BG004|Baseline|CD24Fc 120 mg|Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262244|NCT02650895|BG005|Baseline|CD24Fc 240 mg|Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262245|NCT02650895|BG006|Baseline|Total|Total of all reporting groups
11262246|NCT02650895|FG000|Participant Flow|Saline|Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
11262247|NCT02650895|FG001|Participant Flow|CD24Fc 10 mg|Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262248|NCT02650895|FG002|Participant Flow|CD24Fc 30 mg|Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262249|NCT02650895|FG003|Participant Flow|CD24Fc 60 mg|Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262250|NCT02650895|FG004|Participant Flow|CD24Fc 120 mg|Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262251|NCT02650895|FG005|Participant Flow|CD24Fc 240 mg|Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262252|NCT02650895|OG000|Outcome|Saline|Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
11262253|NCT02650895|OG001|Outcome|CD24Fc 10 mg|Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262254|NCT02650895|OG002|Outcome|CD24Fc 30 mg|Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262255|NCT02650895|OG003|Outcome|CD24Fc 60 mg|Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262256|NCT02650895|OG004|Outcome|CD24Fc 120 mg|Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262257|NCT02650895|OG005|Outcome|CD24Fc 240 mg|Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262258|NCT02650895|OG000|Outcome|CD24Fc 10 mg|Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262259|NCT02650895|OG001|Outcome|CD24Fc 30 mg|Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262260|NCT02650895|OG002|Outcome|CD24Fc 60 mg|Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262261|NCT02650895|OG003|Outcome|CD24Fc 120 mg|Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
11262262|NCT02650895|OG004|Outcome|CD24Fc 240 mg|Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
10820338|NCT00057330|BG000|Baseline|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262263|NCT02650895|EG000|Reported Event|Saline|Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
11262264|NCT02650895|EG001|Reported Event|CD24Fc 10 mg|Single dose of 10 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
11262265|NCT02650895|EG002|Reported Event|CD24Fc 30 mg|Single dose of 30 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
11262266|NCT02650895|EG003|Reported Event|CD24Fc 60 mg|Single dose of 60 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
11262267|NCT02650895|EG004|Reported Event|CD24Fc 120 mg|Single dose of 120 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
11262268|NCT02650895|EG005|Reported Event|CD24Fc 240 mg|Single dose of 240 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
11262269|NCT02650921|BG000|Baseline|Restylane Lyft With Lidocaine|"Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine;~Subjects were randomized to receive Restylane Lyft with Lidocaine in either the right or left hand."
11262270|NCT02650921|FG000|Participant Flow|All Subjects|Subjects randomized to treatment with Restylane Lyft with Lidocaine in one hand and no treatment in the other
11262271|NCT02650921|OG000|Outcome|Restylane Lyft With Lidocaine|Hands randomized to treatment with Restylane Lyft with Lidocaine
11262272|NCT02650921|OG001|Outcome|No Intervention|Hands randomized to no treatment
11262273|NCT02650921|OG000|Outcome|Restylane Lyft With Lidocaine|Subjects that received treatment with Restylane Lyft with Lidocaine
11262274|NCT02650921|EG000|Reported Event|Restylane Lyft With Lidocaine|Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine
11286701|NCT02891681|BG002|Baseline|NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286702|NCT02891681|BG003|Baseline|Total|Total of all reporting groups
11286703|NCT02891681|FG000|Participant Flow|NIR/US (Neoadjuvant Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286704|NCT02891681|FG001|Participant Flow|NIR/US (Neoadjuvant Endocrine Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286705|NCT02891681|FG002|Participant Flow|NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286706|NCT02891681|OG000|Outcome|NIR/US (Neoadjuvant Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286707|NCT02891681|OG001|Outcome|NIR/US (Neoadjuvant Endocrine Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286708|NCT02891681|OG002|Outcome|NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286709|NCT02891681|EG000|Reported Event|NIR/US (Neoadjuvant Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286710|NCT02891681|EG001|Reported Event|NIR/US (Neoadjuvant Endocrine Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11286711|NCT02891681|EG002|Reported Event|NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)|"Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.~In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.~The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen"
11262275|NCT02650999|BG000|Baseline|Single Arm|Pembrolizumab: 200mg intravenously (IV)
11262276|NCT02650999|FG000|Participant Flow|Pembrolizumab|Pembrolizumab: 200mg intravenously (IV)
11262277|NCT02650999|OG000|Outcome|Single Arm|Pembrolizumab: 200mg intravenously (IV)
11262278|NCT02650999|EG000|Reported Event|Single Arm|Pembrolizumab: 200mg intravenously (IV)
11262279|NCT02651103|BG000|Baseline|Posterior Spinal Fusion|"Patients undergoing spinal fusion surgery~NIRS: Cerebral oxygenation monitor which is standard of care for this surgery."
11262280|NCT02651103|FG000|Participant Flow|Posterior Spinal Fusion|"Patients undergoing spinal fusion surgery~NIRS: Cerebral oxygenation monitor which is standard of care for this surgery."
11262281|NCT02651103|OG000|Outcome|Posterior Spinal Fusion|"Patients undergoing spinal fusion surgery~NIRS: Cerebral oxygenation monitor which is standard of care for this surgery."
11262282|NCT02651103|EG000|Reported Event|Posterior Spinal Fusion|"Patients undergoing spinal fusion surgery~NIRS: Cerebral oxygenation monitor which is standard of care for this surgery."
11262283|NCT02651116|BG000|Baseline|Dextromethorphan Hydrobromide|Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262284|NCT02651116|BG001|Baseline|Placebo|Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262285|NCT02651116|BG002|Baseline|Total|Total of all reporting groups
11262286|NCT02651116|FG000|Participant Flow|Dextromethorphan Hydrobromide|Participants were randomized to receive 9 doses of DXM HBr (15 milligram [mg] per 10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262287|NCT02651116|FG001|Participant Flow|Placebo|Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262288|NCT02651116|OG000|Outcome|Dextromethorphan Hydrobromide|Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262289|NCT02651116|OG001|Outcome|Placebo|Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262290|NCT02651116|EG000|Reported Event|Dextromethorphan Hydrobromide|Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262291|NCT02651116|EG001|Reported Event|Placebo|Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
11262292|NCT02651155|BG000|Baseline|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
11262293|NCT02651155|BG001|Baseline|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
11262294|NCT02651155|BG002|Baseline|Total|Total of all reporting groups
11262295|NCT02651155|FG000|Participant Flow|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
10820339|NCT00057330|BG001|Baseline|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
10820340|NCT00057330|BG002|Baseline|Total|Total of all reporting groups
11262296|NCT02651155|FG001|Participant Flow|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
11262297|NCT02651155|OG000|Outcome|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
11262298|NCT02651155|OG001|Outcome|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
11262299|NCT02651155|EG000|Reported Event|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, for up to 4 weeks.
11262300|NCT02651155|EG001|Reported Event|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, for up to 4 weeks.
11262301|NCT02651194|BG000|Baseline|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11262302|NCT02651194|FG000|Participant Flow|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11262303|NCT02651194|OG000|Outcome|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11262304|NCT02651194|EG000|Reported Event|ABT-493/ABT-530|ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11262305|NCT02651220|BG000|Baseline|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w|Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262306|NCT02651220|BG001|Baseline|Epiduo® Forte Gel 0.3%/2.5% w/w|Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262307|NCT02651220|BG002|Baseline|Vehicle Topical Gel|Placebo gel: vehicle used as placebo
11262308|NCT02651220|BG003|Baseline|Total|Total of all reporting groups
11262309|NCT02651220|FG000|Participant Flow|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w|Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262310|NCT02651220|FG001|Participant Flow|Epiduo® Forte Gel 0.3%/2.5% w/w|Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262311|NCT02651220|FG002|Participant Flow|Vehicle Topical Gel|Placebo gel: vehicle used as placebo
11262312|NCT02651220|OG000|Outcome|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w|Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262313|NCT02651220|OG001|Outcome|Epiduo® Forte Gel 0.3%/2.5% w/w|Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262314|NCT02651220|OG002|Outcome|Vehicle Topical Gel|Placebo gel: vehicle used as placebo
11262315|NCT02651220|EG000|Reported Event|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w|Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262316|NCT02651220|EG001|Reported Event|Epiduo® Forte Gel 0.3%/2.5% w/w|Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
11262317|NCT02651220|EG002|Reported Event|Vehicle Topical Gel|Placebo gel: vehicle used as placebo
11262318|NCT02651259|BG000|Baseline|Cohort 1 (Pregnant Women Enrolled in the Second Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262319|NCT02651259|BG001|Baseline|Cohort 2 (Pregnant Women Enrolled in the Third Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262320|NCT02651259|BG002|Baseline|Total|Total of all reporting groups
11262321|NCT02651259|FG000|Participant Flow|Cohort 1 (Pregnant Women Enrolled in the Second Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262322|NCT02651259|FG001|Participant Flow|Cohort 2 (Pregnant Women Enrolled in the Third Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262323|NCT02651259|OG000|Outcome|Cohort 1 (Pregnant Women Enrolled in the Second Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262324|NCT02651259|OG001|Outcome|Cohort 2 (Pregnant Women Enrolled in the Third Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262325|NCT02651259|OG000|Outcome|All Cohorts|Combined for all women in Second and Third Trimester of pregnancy
11262326|NCT02651259|OG000|Outcome|Cohort 1 (Infants Born to Women Enrolled in Second Trimester)|Infants born to women who received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262327|NCT02651259|OG001|Outcome|Cohort 2 (Infants Born to Women Enrolled in Third Trimester)|Infants born to women who received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262328|NCT02651259|OG000|Outcome|All Cohorts|All postpartum women
11262329|NCT02651259|OG000|Outcome|All Cohorts|Combined for all infants born to women in Second and Third Trimester of pregnancy
11262330|NCT02651259|OG000|Outcome|Cohort 1(Infants Born to Women Enrolled in Second Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262331|NCT02651259|OG001|Outcome|Cohort 2 (Infants Born to Women Enrolled in Third Trimester)|Participants will receive 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262332|NCT02651259|OG000|Outcome|All Cohorts|All participants with intensive and sparse PK results at all doses in all stages of pregnancy were used for analysis
11262333|NCT02651259|EG000|Reported Event|Cohort 1 (Pregnant Women Enrolled in Their Second Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262334|NCT02651259|EG001|Reported Event|Cohort 2 (Pregnant Women Enrolled in Their Third Trimester)|Participants received 12 directly observed once-weekly doses of RPT, INH, and pyridoxine (vitamin B6) at study entry and at 11 weekly follow-up visits.
11262335|NCT02651272|BG000|Baseline|Macitentan|"10mg macitentan tablets, taken once daily (QD), by mouth (PO), for the treatment period lasting 16 weeks.~macitentan: 10mg macitentan tablets"
11262336|NCT02651272|FG000|Participant Flow|Macitentan|"10mg macitentan tablets, taken once daily (QD), by mouth (PO), for the treatment period lasting 16 weeks.~macitentan: 10mg macitentan tablets"
11262337|NCT02651272|OG000|Outcome|Macitentan|"10mg macitentan tablets, taken once daily (QD), by mouth (PO), for the treatment period lasting 16 weeks.~macitentan: 10mg macitentan tablets"
11262338|NCT02651272|EG000|Reported Event|Macitentan|"10mg macitentan tablets, taken once daily (QD), by mouth (PO), for the treatment period lasting 16 weeks.~macitentan: 10mg macitentan tablets"
11262339|NCT02651337|BG000|Baseline|Drainage With Alivio In-line Flusher|"Volume of saline needed to drain CSF using the Alivio in-line Flusher historically compared with volume of saline needed to drain CSF using a standard syringe~Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage"
11262340|NCT02651337|FG000|Participant Flow|Drainage With Alivio In-line Flusher|"Volume of saline needed to drain CSF using the Alivio in-line Flusher historically compared with volume of saline needed to drain CSF using a standard syringe~Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage"
11262341|NCT02651337|OG000|Outcome|Alivio Ventricular Flusher Device|The Alivio Ventricular Flusher Device (Flusher) is used in the treatment of patients with hydrocephalus. It is an accessory component that may be connected to a shunt system, which is designed to aid in resuming flow in a non-flowing ventricular catheter.
11262342|NCT02651337|EG000|Reported Event|Drainage With Alivio In-line Flusher|"Volume of saline needed to drain CSF using the Alivio in-line Flusher historically compared with volume of saline needed to drain CSF using a standard syringe~Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage"
11262343|NCT02651415|BG000|Baseline|Regorafenib and Perindopril|"Phase II, open label, single arm trial of patient with refractory metastatic colorectal carcinoma (mCRC) treated with regorafenib (10 mg/day) and perindopril (4 mg/day). There will be no stratification in this study.~Regorafenib: Stivarga® will be used as per the marketed indication (on label), Coversyl will be used off-label and as such a Clinical Trial Application will be filed with Health Canada.~Regorafenib will be administered 160 mg daily for 21 days of a 28 day cycle. Regorafenib will be administered with low fat breakfast, one hour after perindopril. A low fat breakfast as defined by the Stivarga ® (regorafenib) Product Monograph is one that is <30% fat, ~300-550 calories.~Perindopril: COVERSYL® (perindopril erbumine) 4 mg will be administered daily for 21 days of a 28 day cycle. Perindopril will be administered orally, first thing in the morning on an empty stomach."
11262344|NCT02651415|FG000|Participant Flow|Single Arm Trial|All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
11262345|NCT02651415|OG000|Outcome|Single Arm Trial|All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
11262346|NCT02651415|EG000|Reported Event|Single Arm Trial|All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
11262347|NCT02651428|BG000|Baseline|Neutrolin Arm|"Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution~Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262348|NCT02651428|BG001|Baseline|Heparin Arm|"Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution~Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262349|NCT02651428|BG002|Baseline|Total|Total of all reporting groups
11262350|NCT02651428|FG000|Participant Flow|Neutrolin Arm|"Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution~Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262351|NCT02651428|FG001|Participant Flow|Heparin Arm|"Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution~Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262352|NCT02651428|OG000|Outcome|Neutrolin Arm|"Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution~Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262353|NCT02651428|OG001|Outcome|Heparin Arm|"Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution~Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262354|NCT02651428|EG000|Reported Event|Neutrolin Arm|"Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution~Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
11262355|NCT02651428|EG001|Reported Event|Heparin Arm|"Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution~Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session"
10820341|NCT00057330|FG000|Participant Flow|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262356|NCT02651467|BG000|Baseline|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262357|NCT02651467|BG001|Baseline|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262358|NCT02651467|BG002|Baseline|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262359|NCT02651467|BG003|Baseline|Total|Total of all reporting groups
11262360|NCT02651467|FG000|Participant Flow|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% weight by weight [w/w] KOX, 0 parts per million [ppm], pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262361|NCT02651467|FG001|Participant Flow|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262362|NCT02651467|FG002|Participant Flow|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262363|NCT02651467|OG000|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262364|NCT02651467|OG001|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262365|NCT02651467|OG002|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262366|NCT02651467|OG002|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )(using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262367|NCT02651467|EG000|Reported Event|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262368|NCT02651467|EG001|Reported Event|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262369|NCT02651467|EG002|Reported Event|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
11262370|NCT02651545|BG000|Baseline|MS Group|Multiple Sclerosis Patients Prescribed Aubagio
11262371|NCT02651545|BG001|Baseline|Healthy Control Group|Healthy controls matched to the MS group
11262372|NCT02651545|BG002|Baseline|Total|Total of all reporting groups
11262373|NCT02651545|FG000|Participant Flow|Relapsing MS Patients|Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
10820342|NCT00057330|FG001|Participant Flow|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262374|NCT02651545|FG001|Participant Flow|Healthy Controls|A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
11262375|NCT02651545|OG000|Outcome|Relapsing MS Patients|Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
11262376|NCT02651545|OG001|Outcome|Healthy Controls|A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
11262377|NCT02651545|EG000|Reported Event|MS Group|Multiple Sclerosis Patients Prescribed Aubagio
11262378|NCT02651545|EG001|Reported Event|Healthy Controls|This sample 30 healthy control volunteers, matched on demographics with the multiple sclerosis group. This healthy control group was not prescribed Aubagio.
11262379|NCT02651584|BG000|Baseline|Group 1: SL BP/NX Tablets + Placebo SC Injections|"SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262380|NCT02651584|BG001|Baseline|Group 2: CAM2038 SC Injections + SL Placebo Tablets|"CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).~CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).~SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily"
11262381|NCT02651584|BG002|Baseline|Total|Total of all reporting groups
11262382|NCT02651584|FG000|Participant Flow|Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections|"SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262383|NCT02651584|FG001|Participant Flow|Group 2: CAM2038 SC Injections + SL Placebo Tablets|"CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).~CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).~SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily"
11262384|NCT02651584|OG000|Outcome|Group 1: SL BP/NX Tablets + Placebo SC Injections|"SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262385|NCT02651584|OG001|Outcome|Group 2: CAM2038 SC Injections + SL Placebo Tablets|"CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).~CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).~SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily"
11262386|NCT02651584|OG000|Outcome|SL BPN Tablets + Placebo Subcutaneous (SC) Injections|"SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262387|NCT02651584|OG000|Outcome|Group 1: SL BPN/NX Tabs+ Placebo Subcutaneous (SC) Injections|"SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262388|NCT02651584|OG000|Outcome|Group 1: SL BPN/NX Tablets + Placebo SC Injections|"SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262389|NCT02651584|EG000|Reported Event|Group 1: SL BPN/NX Tablets + Placebo SC Injections|"SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w)."
11262390|NCT02651584|EG001|Reported Event|Group 2: CAM2038 SC Injections + SL Placebo Tablets|"CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).~CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).~SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily"
11262391|NCT02651688|BG000|Baseline|Enclomiphene 12.5 mg|Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262392|NCT02651688|BG001|Baseline|Enclomiphene 25 mg|Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262393|NCT02651688|BG002|Baseline|Placebo|One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262394|NCT02651688|BG003|Baseline|Total|Total of all reporting groups
11262395|NCT02651688|FG000|Participant Flow|Enclomiphene 12.5 mg|Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262396|NCT02651688|FG001|Participant Flow|Enclomiphene 25 mg|Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262397|NCT02651688|FG002|Participant Flow|Placebo|One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262398|NCT02651688|OG000|Outcome|Enclomiphene 12.5 mg|Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262399|NCT02651688|OG001|Outcome|Enclomiphene 25 mg|Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262400|NCT02651688|OG002|Outcome|Placebo|One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262401|NCT02651688|EG000|Reported Event|Enclomiphene 12.5 mg|Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262402|NCT02651688|EG001|Reported Event|Enclomiphene 25 mg|Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262403|NCT02651688|EG002|Reported Event|Placebo|One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
11262404|NCT02651922|BG000|Baseline|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
11262405|NCT02651922|FG000|Participant Flow|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
11262406|NCT02651922|OG000|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
11262407|NCT02651922|EG000|Reported Event|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
11262408|NCT02651987|BG000|Baseline|PanNET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262409|NCT02651987|BG001|Baseline|Midgut NET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262410|NCT02651987|BG002|Baseline|Total|Total of all reporting groups
11262411|NCT02651987|FG000|Participant Flow|Pancreatic NET (panNET) Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep subcutaneous (SC) injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (progressive disease [PD] or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262412|NCT02651987|FG001|Participant Flow|Midgut NET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262413|NCT02651987|OG000|Outcome|PanNET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262414|NCT02651987|OG001|Outcome|Midgut NET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262415|NCT02651987|OG000|Outcome|PanNET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability
11262416|NCT02651987|OG002|Outcome|Overall|All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
11286712|NCT02891850|BG000|Baseline|Riociguat|Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks.
11262417|NCT02651987|EG000|Reported Event|PanNET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262418|NCT02651987|EG001|Reported Event|Midgut NET Cohort|Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
11262419|NCT02651987|EG002|Reported Event|Overall Subjects|All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
11262420|NCT02652156|BG000|Baseline|Single Injection of Bupivacaine|"Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.~Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block."
11262421|NCT02652156|BG001|Baseline|Single Injection of Exparel®|"Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane~Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block."
11262422|NCT02652156|BG002|Baseline|Continuous Infusion of Ropivacaine|"Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump~Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side."
11262423|NCT02652156|BG003|Baseline|Total|Total of all reporting groups
11262424|NCT02652156|FG000|Participant Flow|Single Injection of Bupivacaine|"Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.~Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block."
11262425|NCT02652156|FG001|Participant Flow|Single Injection of Exparel®|"Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane~Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block."
11262426|NCT02652156|FG002|Participant Flow|Continuous Infusion of Ropivacaine|"Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump~Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side."
11286713|NCT02891850|BG001|Baseline|PDE-5i|Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator.
11286714|NCT02891850|BG002|Baseline|Total|Total of all reporting groups
10970000|NCT00908375|OG000|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
10970001|NCT00908375|OG001|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
11262427|NCT02652156|OG000|Outcome|Single Injection of Bupivacaine|"Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.~Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block."
11262428|NCT02652156|OG001|Outcome|Single Injection of Exparel®|"Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane~Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block."
11262429|NCT02652156|OG002|Outcome|Continuous Infusion of Ropivacaine|"Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump~Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side."
11262430|NCT02652156|EG000|Reported Event|Single Injection of Bupivacaine|"Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.~Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block."
11262431|NCT02652156|EG001|Reported Event|Single Injection of Exparel®|"Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane~Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block."
11262432|NCT02652156|EG002|Reported Event|Continuous Infusion of Ropivacaine|"Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump~Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side."
11262433|NCT02652208|BG000|Baseline|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
11262434|NCT02652208|BG001|Baseline|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
11262435|NCT02652208|BG002|Baseline|Total|Total of all reporting groups
10820343|NCT00057330|OG000|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262436|NCT02652208|FG000|Participant Flow|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
11262437|NCT02652208|FG001|Participant Flow|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
11262438|NCT02652208|OG000|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
11262439|NCT02652208|OG001|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
11262440|NCT02652208|EG000|Reported Event|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.~Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
11262441|NCT02652208|EG001|Reported Event|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.~Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
11262442|NCT02652221|BG000|Baseline|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
11262443|NCT02652221|FG000|Participant Flow|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
11262444|NCT02652221|OG000|Outcome|BMI <30 kg/m2|Subset of study cohort with BMI <30 kg/m2
11262445|NCT02652221|OG001|Outcome|BMI >30kg/m2|Subset of study cohort with BMI 30 kg/m2 or more
11262446|NCT02652221|EG000|Reported Event|Study Cohort|"Acoustic Radiation Force Imaging~Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
11262447|NCT02652260|BG000|Baseline|Immediate Switch to MK-1439A|Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
11262448|NCT02652260|BG001|Baseline|Deferred Switch to MK-1439A|Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
11262449|NCT02652260|BG002|Baseline|Total|Total of all reporting groups
11262450|NCT02652260|FG000|Participant Flow|Immediate Switch to MK-1439A|Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
11262451|NCT02652260|FG001|Participant Flow|Deferred Switch to MK-1439A|Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
11262452|NCT02652260|OG000|Outcome|Immediate Switch to MK-1439A|Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
11262453|NCT02652260|OG001|Outcome|Deferred Switch to MK-1439A|Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
11262454|NCT02652260|OG000|Outcome|Combined Treatment Groups: Time of Switch|"Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.~Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks."
11262455|NCT02652260|OG001|Outcome|Combined Treatment Groups: Week 24 Post-Switch|"Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.~Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks."
11262456|NCT02652260|OG000|Outcome|Combined Treatment Groups|"Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.~Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks."
11262457|NCT02652260|EG000|Reported Event|Immediate Switch to MK-1439A|Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
11262458|NCT02652260|EG001|Reported Event|Deferred Switch to MK-1439A|Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
11262459|NCT02652390|BG000|Baseline|Methylprednisolone 80 mg|"Local injection of 80 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine"
11262460|NCT02652390|BG001|Baseline|Methylprednisolone 40 mg|"Local injection of 40 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine"
11262461|NCT02652390|BG002|Baseline|Placebo|"Local injection of saline into the carpal tunnel~Saline: 2 mL saline + 1 mL lidocaine"
11262462|NCT02652390|BG003|Baseline|Total|Total of all reporting groups
11262463|NCT02652390|FG000|Participant Flow|Methylprednisolone 80 mg|"Local injection of 80 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine"
11262464|NCT02652390|FG001|Participant Flow|Methylprednisolone 40 mg|"Local injection of 40 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine"
11262465|NCT02652390|FG002|Participant Flow|Placebo|"Local injection of saline into the carpal tunnel~Saline: 2 mL saline + 1 mL lidocaine"
11262466|NCT02652390|OG000|Outcome|Methylprednisolone 80 mg|"Local injection of 80 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine"
11262467|NCT02652390|OG001|Outcome|Methylprednisolone 40 mg|"Local injection of 40 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine"
11262468|NCT02652390|OG002|Outcome|Placebo|"Local injection of saline into the carpal tunnel~Saline: 2 mL saline + 1 mL lidocaine"
11262469|NCT02652390|OG000|Outcome|80-mg Mrthylprednisolone and no Surgery|Patients in the 80-mg methylprednisolone group who had not undergone carpal tunnel release surgery on the study hand
11262470|NCT02652390|OG001|Outcome|Surgery After Methylprednisolone or Placebo|Patients in the methylprednisolone or placebo groups who had undergone carpal tunnel release surgery after injection.
11262471|NCT02652390|EG000|Reported Event|Methylprednisolone 80 mg|"Local injection of 80 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine"
11262472|NCT02652390|EG001|Reported Event|Methylprednisolone 40 mg|"Local injection of 40 mg Methylprednisolone into the carpal tunnel~Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine"
11262473|NCT02652390|EG002|Reported Event|Placebo|"Local injection of saline into the carpal tunnel~Saline: 2 mL saline + 1 mL lidocaine"
11262474|NCT02652416|BG000|Baseline|Placebo|The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).
11262475|NCT02652416|BG001|Baseline|BI 1026706 25 mg|The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262476|NCT02652416|BG002|Baseline|BI 1026706 50 mg|The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.
11262477|NCT02652416|BG003|Baseline|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
11262478|NCT02652416|BG004|Baseline|Total|Total of all reporting groups
11262479|NCT02652416|FG000|Participant Flow|Placebo|The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).
11262480|NCT02652416|FG001|Participant Flow|BI 1026706 25 mg|The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262481|NCT02652416|FG002|Participant Flow|BI 1026706 50 mg|The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.
11262482|NCT02652416|FG003|Participant Flow|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
11262483|NCT02652416|OG000|Outcome|Placebo|The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).
11262484|NCT02652416|OG001|Outcome|BI 1026706 25 mg|The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262485|NCT02652416|OG002|Outcome|BI 1026706 50 mg|The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.
11262486|NCT02652416|OG003|Outcome|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
11262487|NCT02652416|OG000|Outcome|BI 1026706 25 mg|The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262488|NCT02652416|OG001|Outcome|BI 1026706 50 mg|The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.
11262489|NCT02652416|OG002|Outcome|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262490|NCT02652416|OG000|Outcome|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablets twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
11262491|NCT02652416|EG000|Reported Event|Placebo|The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).
11262492|NCT02652416|EG001|Reported Event|BI 1026706 25 mg|The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
11262493|NCT02652416|EG002|Reported Event|BI 1026706 50 mg|The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.
11262494|NCT02652416|EG003|Reported Event|BI 1026706 100 mg|The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
11286715|NCT02891850|FG000|Participant Flow|Riociguat|Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks.
11262495|NCT02652442|BG000|Baseline|Centrifugation Distance|"Each subject will complete training at both chair positions (3.5 cm off-axis and 7.0 cm off-axis). Subjects will be randomized to start with either chair position (3.5 cm or 7.0 cm) and have a wash out period of at least 2 weeks in between chair training distance (3.5 cm or 7.0 cm) until static SVV returns to normal.~Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm or 7.0 cm off-axis and the other ear positioned on-axis. Participants will receive 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo will be assessed at the start and end of each session."
11262496|NCT02652442|FG000|Participant Flow|Centrifugation|"Each subject will complete training at 3.5 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis. Subjects will have a wash out period of at least 2 weeks in between chair training distance (3.5 cm or 7.0 cm) until static SVV returns to normal. Then subjects will complete training at 7.0 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis.~Participants will receive 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo will be assessed at the start and end of each session."
11262497|NCT02652442|OG000|Outcome|Centrifugation Distance - 3.5 cm|"Each subject completed training at chair position of 3.5 cm off-axis.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session."
11262498|NCT02652442|OG001|Outcome|Centrifugation Distance - 7.0 cm|"Each subject completed training at chair position of 7.0 cm off-axis after completing training with chair position at 3.5 cm off-axis and having a wash out period of at least 2 weeks (or until static SVV returned to normal) prior to chair training at distance of 7.0 cm.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session."
11262499|NCT02652442|OG002|Outcome|Centrifugation Duration - 1 Minute|"Each subject completed training at chair position of 3.5 cm off-axis.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute duration. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session."
11262500|NCT02652442|OG003|Outcome|Centrifugation Duration - 3 Minutes|"After a wash out period of at least 2 weeks (or until static SVV returns to normal), each subject completed training at chair position of 3.5 cm off-axis.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes duration. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session."
11262501|NCT02652442|OG004|Outcome|Centrifugation Schedule - Daily|"After a wash out period of at least 2 weeks (or until static SVV returned to normal), each subject completed training at chair position of 3.5 cm off-axis.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session."
11262502|NCT02652442|OG005|Outcome|Centrifugation Schedule - Biweekly|"After a wash out period of at least 2 weeks (or until static SVV returned to normal), each subject completed training at chair position of 3.5 cm off-axis.~Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received biweekly sessions for a total of 5 sessions. Static subjective visual vertigo was assessed at the start and end of each session."
11262503|NCT02652442|EG000|Reported Event|Centrifugation Distance - 3.5|Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 1 daily session for 5 consecutive days.
11262504|NCT02652442|EG001|Reported Event|Centrifugation Distance - 7.0|Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 1 daily session for 5 consecutive days.
11262505|NCT02652442|EG002|Reported Event|Centrifugation Duration - 3 Minutes|Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received 1 daily session for 5 consecutive days.
11262506|NCT02652442|EG003|Reported Event|Centrifugation Schedule - Biweekly|Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received biweekly sessions for a total of 5 sessions.
11262507|NCT02652481|BG000|Baseline|ImageReady™ MR Conditional Defibrillation System|"This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the MRI protection mode. This new MRI scan feature was considered investigational , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system."
11286716|NCT02891850|FG001|Participant Flow|PDE-5i|Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator.
11262508|NCT02652481|FG000|Participant Flow|ImageReady MR Conditional Defibrillation System Group|"This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the MRI protection mode. This new MRI scan feature was considered investigational , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system."
11262509|NCT02652481|OG000|Outcome|ImageReady MR Conditional Defibrillation System Group|"This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the MRI protection mode. This new MRI scan feature was considered investigational , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system"
11262510|NCT02652481|EG000|Reported Event|ImageReady MR Conditional Defibrillation System Group|"This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the MRI protection mode. This new MRI scan feature was considered investigational , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system"
11262511|NCT02652624|BG000|Baseline|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.
11262512|NCT02652624|BG001|Baseline|Stay on Baseline Regimen|Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
11262513|NCT02652624|BG002|Baseline|Total|Total of all reporting groups
11262514|NCT02652624|FG000|Participant Flow|B/F/TAF|"Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily for at least 48 weeks, without regard to food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first."
11262515|NCT02652624|FG001|Participant Flow|Stay on Baseline Regimen (SBR)|"Randomized Phase: Participants remained on their baseline regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) tablet, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) tablet, or atazanavir (ATV) 300 mg capsule + ritonavir (RTV) 100 mg tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) tablet for at least 48 weeks with food.~Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first."
11262516|NCT02652624|OG000|Outcome|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.
11262517|NCT02652624|OG001|Outcome|Stay on Baseline Regimen|Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
11262518|NCT02652624|EG000|Reported Event|B/F/TAF (Randomized Phase)|Adverse events reported occurred during the Randomized Phase in participants from the B/F/TAF group, who received B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks.
11262519|NCT02652624|EG001|Reported Event|Stay on Baseline Regimen (Randomized Phase)|Adverse events reported occurred during the Randomized Phase in participants from the SBR group, who remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks.
11262520|NCT02652624|EG002|Reported Event|Extension Phase B/F/TAF From B/F/TAF|Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the B/F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
11262521|NCT02652624|EG003|Reported Event|Extension Phase B/F/TAF From Stay on Baseline Regimen|Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the SBR group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
11286717|NCT02891850|OG000|Outcome|Riociguat|Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks.
11262522|NCT02652767|BG000|Baseline|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure simultaneously. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to receive GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262523|NCT02652767|FG000|Participant Flow|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure simultaneously. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to receive GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262524|NCT02652767|OG000|Outcome|GS010-treated Eyes|"All eyes that received the study treatment, GS010. Each participant was randomly assigned GS010 in either the right or left eye. The eye assigned to GS010 received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 μL. The injection was performed in the vitreous humor under local anesthesia.~The same participants also received the sham procedure in the right or left eye, which was not assigned to receive GS010, at the same study visit."
11262525|NCT02652767|OG001|Outcome|Sham-treated Eyes|"All eyes that received the Sham. Each participant was randomly assigned GS010 in either the right or left eye, the eye not assigned GS010 received the sham procedure. The eye assigned to the Sham received one single sham intravitreal (IVT) injection, which was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle.~The same participants also received GS010 in the right or left eye, which did not receive the sham procedure, at the same study visit."
11262526|NCT02652767|OG000|Outcome|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to receive GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262527|NCT02652767|EG000|Reported Event|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure simultaneously. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to receive GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262528|NCT02652780|BG000|Baseline|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure simultaneously. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham procedure: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262529|NCT02652780|FG000|Participant Flow|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. All participants in the study received both GS010 and the sham procedure simultaneously. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham procedure in the eye not assigned to GS010, at the same study visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham procedure: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262530|NCT02652780|OG000|Outcome|GS010-treated Eyes|"All eyes that received the study treatment, GS010. Each participant was randomly assigned GS010 in either the right or left eye. The eye assigned to GS010 received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 μL. The injection was performed in the vitreous humor under local anesthesia.~The same participants also received the sham procedure in the right or left eye, which was not assigned to receive GS010, at the same study visit."
11262531|NCT02652780|OG001|Outcome|Sham-treated Eyes|"All eyes that received the Sham. Each participant was randomly assigned GS010 in either the right or left eye, the eye not assigned GS010 received the sham procedure. The eye assigned to the Sham received one single sham intravitreal (IVT) injection, which was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle.~The same participants also received GS010 in the right or left eye, which did not receive the Sham, at the same study visit."
11262532|NCT02652780|OG001|Outcome|Sham-treated Eyes|"All eyes that received the Sham. Each participant was randomly assigned GS010 in either the right or left eye, the eye not assigned GS010 received the sham procedure. The eye assigned to the Sham received one single sham intravitreal (IVT) injection, which was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle.~The same participants also received GS010 in the right or left eye, which did not receive the sham procedure, at the same study visit."
11262533|NCT02652780|OG000|Outcome|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham comparator in the eye not assigned to GS010 at the same visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham procedure: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262534|NCT02652780|EG000|Reported Event|All Participants|"All participants who were enrolled and received both study treatments, GS010 and Sham. Participants were randomly assigned to receive GS010 in either the right or left eye. The same participants also received the sham comparator in the eye not assigned to GS010 at the same visit.~GS010: Either the right or left eye received one single dose of GS010 (9E10 vg/eye) via an intravitreal (IVT) injection. The volume of the injected formula was 90 µL. The injection was performed in the vitreous humor under local anesthesia.~Sham procedure: Either the right or left eye (the eye not randomly assigned to GS010) received the sham procedure. One single sham IVT injection was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle."
11262535|NCT02653144|BG000|Baseline|Dexmedetomidine and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262536|NCT02653144|BG001|Baseline|Dexamethasone and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262537|NCT02653144|BG002|Baseline|Ropivacaine Only Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262538|NCT02653144|BG003|Baseline|Total|Total of all reporting groups
11262539|NCT02653144|FG000|Participant Flow|Dexmedetomidine and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262540|NCT02653144|FG001|Participant Flow|Dexamethasone and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262541|NCT02653144|FG002|Participant Flow|Ropivacaine Only Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11286718|NCT02891850|OG001|Outcome|PDE-5i|Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator.
11286719|NCT02891850|EG000|Reported Event|Riociguat|Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks.
11262542|NCT02653144|OG000|Outcome|Dexmedetomidine and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262543|NCT02653144|OG001|Outcome|Dexamethasone and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262544|NCT02653144|OG002|Outcome|Ropivacaine Only Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262545|NCT02653144|EG000|Reported Event|Dexmedetomidine and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262546|NCT02653144|EG001|Reported Event|Dexamethasone and Ropivacaine Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery~Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262547|NCT02653144|EG002|Reported Event|Ropivacaine Only Group|"In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)~Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery"
11262548|NCT02653170|BG000|Baseline|Usual Care|Patients in this group will receive the hospitals' usual transitional care approach along with mailings of stroke and health-related brochures to help promote study retention.
11262549|NCT02653170|BG001|Baseline|SWSCM|"One intervention is provided:~1. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~SWSCM program: Stroke Case Managers (SWSCMs) will conduct 2 home visits; one within 72-96 hours and another after 30-days of returning home. SWSCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if as needed.~Biopsychosocial assessment of patient and caregiver needs.~Set up appointments.~Assist scheduling appointments with primary care physician and other medical providers.~Promote medication adherence through medication tool kits, pill organizers and other aids.~Facilitate patient and caregiver engagement and activation.~Facilitate access to social and community services."
11262550|NCT02653170|BG002|Baseline|SWSCM and VSSP Website|"Two interventions are provided:~SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP, a purpose-built, online, patient-centered information and support resource intended to complement the SWSCM program.~SWSCM and VSSP:~SWSCM activities as described in the SWSCM group.~VSSP website: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:~Care team contact list~Hospital patient portal access~Stroke education materials and resources~Access to Michigan 2-1-1 services~Medication information and adherence tools~Patient and Caregiver support networks."
11262551|NCT02653170|BG003|Baseline|Total|Total of all reporting groups
11262552|NCT02653170|FG000|Participant Flow|Usual Care|Patients in this group will receive the hospitals' usual transitional care approach along with mailings of stroke and health-related brochures to help promote study retention.
11262553|NCT02653170|FG001|Participant Flow|SWSCM|"One intervention is provided:~1. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~SWSCM: Stroke Case Managers (SWSCMs) will conduct 2 home visits; one within 72-96 hours and another after 30-days of returning home. SWSCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Home visit activities include:~Biopsychosocial assessment of patient and caregiver needs.~Set up appointments.~Assist scheduling appointments with primary care physician and other medical providers.~Promote medication adherence through medication tool kits, pill organizers and other and activation.~Facilitate patient and caregiver engagement and activation.~Facilitate access to social and community services."
11286720|NCT02891850|EG001|Reported Event|PDE-5i|Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator.
11337454|NCT03585712|FG001|Participant Flow|Arm A: Delayed Then Missed Pill|"Treatment period 2, visit Day 42+/- 3 days: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, visit Day 70+/- 3 days: missed pill of Norgestrel 75 mcg~Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3"
11262554|NCT02653170|FG002|Participant Flow|SWSCM and VSSP Website|"Two interventions are provided:~SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP, a purpose-built, online, patient-centered information and support resource intended to complement the SWSCM program.~SWSCM and VSSP:~SWSCM activities as described in the SWSCM group.~VSSP website: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:~Care team contact list~Hospital patient portal access~Stroke education materials and resources~Access to Michigan 2-1-1 services~Medication information and adherence tools~Patient and Caregiver support networks"
11262555|NCT02653170|OG000|Outcome|Usual Care|Patients in this group will receive the hospitals' usual transitional care approach along with mailings of stroke and health-related brochures to help promote study retention.
11262556|NCT02653170|OG001|Outcome|SWSCM|"One intervention is provided:~1. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~SWSCM: Stroke Case Managers (SWSCMs) will conduct 2 home visits; one within 72-96 hours and another after 30-days of returning home. SWSCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Home visit activities include:~Biopsychosocial assessment of patient and caregiver needs.~Set up appointments.~Assist scheduling appointments with primary care physician and other medical providers.~Promote medication adherence through medication tool kits, pill organizers and other and activation.~Facilitate patient and caregiver engagement and activation.~Facilitate access to social and community services."
11262557|NCT02653170|OG002|Outcome|SWSCM and VSSP Website|"Two interventions are provided:~SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP, a purpose-built, online, patient-centered information and support resource intended to complement the SWSCM program.~SWSCM and VSSP:~SWSCM activities as described in the SWSCM group.~VSSP website: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:~Care team contact list~Hospital patient portal access~Stroke education materials and resources~Access to Michigan 2-1-1 services~Medication information and adherence tools~Patient and Caregiver support networks"
11262558|NCT02653170|EG000|Reported Event|Usual Care|Patients in this group will receive the hospitals' usual transitional care approach along with mailings of stroke and health-related brochures to help promote study retention.
11262559|NCT02653170|EG001|Reported Event|SWSCM|"One intervention is provided:~1. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~SWSCM: Stroke Case Managers (SWSCMs) will conduct 2 home visits; one within 72-96 hours and another after 30-days of returning home. SWSCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Home visit activities include:~Biopsychosocial assessment of patient and caregiver needs.~Set up appointments.~Assist scheduling appointments with primary care physician and other medical providers.~Promote medication adherence through medication tool kits, pill organizers and other and activation.~Facilitate patient and caregiver engagement and activation.~Facilitate access to social and community services."
11262560|NCT02653170|EG002|Reported Event|SWSCM and VSSP Website|"Two interventions are provided:~SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.~VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP, a purpose-built, online, patient-centered information and support resource intended to complement the SWSCM program.~SWSCM and VSSP:~SWSCM activities as described in the SWSCM group.~VSSP website: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:~Care team contact list~Hospital patient portal access~Stroke education materials and resources~Access to Michigan 2-1-1 services~Medication information and adherence tools~Patient and Caregiver support networks"
11262561|NCT02653183|BG000|Baseline|Device Mepilex Border Post-Op|"Post-operative all-in-one self-adherent soft silicone coated foam dressing.~Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing"
11262562|NCT02653183|BG001|Baseline|Device Aquacel Surgical|"Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.~Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing"
11262563|NCT02653183|BG002|Baseline|Total|Total of all reporting groups
11262564|NCT02653183|FG000|Participant Flow|Device Mepilex Border Post-Op|"Post-operative all-in-one self-adherent soft silicone coated foam dressing.~Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing"
11262565|NCT02653183|FG001|Participant Flow|Device Aquacel Surgical|"Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.~Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing"
11262566|NCT02653183|OG000|Outcome|Device Mepilex Border Post-Op|"Post-operative all-in-one self-adherent soft silicone coated foam dressing.~Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing"
11262567|NCT02653183|OG001|Outcome|Device Aquacel Surgical|"Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.~Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing"
11262568|NCT02653183|EG000|Reported Event|Device Mepilex Border Post-Op|"Post-operative all-in-one self-adherent soft silicone coated foam dressing.~Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing"
11262569|NCT02653183|EG001|Reported Event|Device Aquacel Surgical|"Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.~Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing"
11262570|NCT02653300|BG000|Baseline|Oral Insulin|"treatment~Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801."
11262571|NCT02653300|FG000|Participant Flow|Oral Insulin|"treatment~Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801."
11262572|NCT02653300|OG000|Outcome|Oral Insulin|"treatment~Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801."
11262573|NCT02653300|EG000|Reported Event|Oral Insulin|"treatment~Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801."
11262574|NCT02653326|BG000|Baseline|Telerehabilitation|"In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.~Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment."
11262575|NCT02653326|BG001|Baseline|Routine Care|"Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:~Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.~Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.~Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician."
11262576|NCT02653326|BG002|Baseline|Total|Total of all reporting groups
11262577|NCT02653326|FG000|Participant Flow|Telerehabilitation|"In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.~Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment."
11262578|NCT02653326|FG001|Participant Flow|Routine Care|"Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:~Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.~Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.~Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician."
11262579|NCT02653326|OG000|Outcome|Telerehabilitation|"In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.~Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment."
11262580|NCT02653326|OG001|Outcome|Routine Care|"Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:~Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.~Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.~Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician."
11262581|NCT02653326|EG000|Reported Event|Telerehabilitation|"In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.~Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment."
11262582|NCT02653326|EG001|Reported Event|Routine Care|"Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:~Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.~Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.~Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician."
11262583|NCT02653391|BG000|Baseline|Elamipretide 1.0% Ophthalmic Solution and Placebo|Part A participants includes those receiving Elamipretide and placebo
11262584|NCT02653391|BG001|Baseline|Part B Elamipretide 3.0% Ophthalmic Solution|Part B Participants includes those receiving Elamipretide.
11262585|NCT02653391|BG002|Baseline|Part B Placebo|Part B Participants include those receiving Placebo.
11213917|NCT02289690|EG001|Reported Event|Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213918|NCT02289690|EG002|Reported Event|Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213919|NCT02289690|EG003|Reported Event|Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213920|NCT02289690|EG004|Reported Event|Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213921|NCT02289690|EG005|Reported Event|Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213922|NCT02289690|EG006|Reported Event|Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide|"Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213923|NCT02289690|EG007|Reported Event|Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213924|NCT02289690|EG008|Reported Event|Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo|"Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213925|NCT02289690|EG009|Reported Event|Phase 2: Placebo + Carboplatin/Etoposide -> Placebo|"Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles.~Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity."
11213926|NCT02289729|BG000|Baseline|All Participants|LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
11213927|NCT02289729|FG000|Participant Flow|All Participants|LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
11213928|NCT02289729|OG000|Outcome|All Participants|LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
11213929|NCT02289729|EG000|Reported Event|All Participants|LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
11213930|NCT02289742|BG000|Baseline|Presbyopes|Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
11213931|NCT02289742|BG001|Baseline|Astigmats|Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
11213932|NCT02289742|BG002|Baseline|Total|Total of all reporting groups
11213933|NCT02289742|FG000|Participant Flow|Presbyopes MF/Sphere|Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
11213934|NCT02289742|FG001|Participant Flow|Presbyopes Sphere/MF|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
11213935|NCT02289742|FG002|Participant Flow|Astigmats Toric/Sphere|Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
11213936|NCT02289742|FG003|Participant Flow|Astigmats Sphere/Toric|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
11213937|NCT02289742|OG000|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
11213938|NCT02289742|OG001|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
11213939|NCT02289742|OG002|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
11213940|NCT02289742|OG003|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
11213941|NCT02289742|OG002|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)
11213942|NCT02289742|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11213943|NCT02289742|EG001|Reported Event|Presbyopes / Multifocal|All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
11213944|NCT02289742|EG002|Reported Event|Presbyopes / Sphere First Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
11213945|NCT02289742|EG003|Reported Event|Presbyopes / Sphere Second Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
11213946|NCT02289742|EG004|Reported Event|Astigmats / Toric|All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
11213947|NCT02289742|EG005|Reported Event|Astigmats / Sphere First Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
11213948|NCT02289742|EG006|Reported Event|Astigmats / Sphere Second Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
11213949|NCT02289755|BG000|Baseline|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
11213950|NCT02289755|FG000|Participant Flow|ALLN-177|ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
11213951|NCT02289755|OG000|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
11213952|NCT02289755|EG000|Reported Event|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
11213953|NCT02289820|BG000|Baseline|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
11213954|NCT02289820|BG001|Baseline|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
11213955|NCT02289820|BG002|Baseline|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213956|NCT02289820|BG003|Baseline|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213957|NCT02289820|BG004|Baseline|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213958|NCT02289820|BG005|Baseline|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213959|NCT02289820|BG006|Baseline|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
11213960|NCT02289820|BG007|Baseline|Total|Total of all reporting groups
11213961|NCT02289820|FG000|Participant Flow|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
11213962|NCT02289820|FG001|Participant Flow|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
11213963|NCT02289820|FG002|Participant Flow|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
11213964|NCT02289820|FG003|Participant Flow|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213965|NCT02289820|FG004|Participant Flow|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213966|NCT02289820|FG005|Participant Flow|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213967|NCT02289820|FG006|Participant Flow|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213968|NCT02289820|OG000|Outcome|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
11213969|NCT02289820|OG001|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213970|NCT02289820|OG002|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213971|NCT02289820|OG003|Outcome|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
11213972|NCT02289820|OG004|Outcome|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
11213973|NCT02289820|OG005|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213974|NCT02289820|OG006|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213975|NCT02289820|OG000|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213976|NCT02289820|OG001|Outcome|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213977|NCT02289820|OG002|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213978|NCT02289820|OG003|Outcome|MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213979|NCT02289820|EG000|Reported Event|MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1|Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
11213980|NCT02289820|EG001|Reported Event|Inactivated Influenza Vaccine (IIV)|Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
11213981|NCT02289820|EG002|Reported Event|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213982|NCT02289820|EG003|Reported Event|MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213983|NCT02289820|EG004|Reported Event|MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
11213984|NCT02289820|EG005|Reported Event|MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3|Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
11213985|NCT02289820|EG006|Reported Event|MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4|Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
11213986|NCT02289833|BG000|Baseline|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213987|NCT02289833|BG001|Baseline|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213988|NCT02289833|BG002|Baseline|Total|Total of all reporting groups
11213989|NCT02289833|FG000|Participant Flow|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213990|NCT02289833|FG001|Participant Flow|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11262586|NCT02653391|BG003|Baseline|Total|Total of all reporting groups
11262587|NCT02653391|FG000|Participant Flow|Elamipretide 1.0% Ophthalmic Solution and Placebo Part A (Cohort 1)|Part A: Each subject will receive one drop of elamipretide 1.0% ophthalmic solution twice daily (BID) in the randomly selected study eye, and Placebo twice daily (BID) in the paired eye.
11262588|NCT02653391|FG001|Participant Flow|Elamipretide 3.0% Ophthalmic Solution Part B (Cohort 2)|"Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution twice daily (BID) in both the right and left study eyes (Cohort 2).~Part B Elamipretide 3.0% Ophthalmic Solution"
11262589|NCT02653391|FG002|Participant Flow|Placebo Part B (Cohort 2)|"Part B Each subject will receive one drop of placebo comparator solution twice daily (BID) in both the right and left study eyes (Cohort 2).~Placebo Part B"
11262590|NCT02653391|OG000|Outcome|Part A Placebo|Part A participants includes those receiving vehicle in eye paired with treatment eye.
11262591|NCT02653391|OG001|Outcome|Part A Elamipretide 1.0% Ophthalmic Solution|Part A participants includes those receiving 1% Elamipretide
11262592|NCT02653391|OG002|Outcome|Part B Placebo|Part B participants includes those receiving vehicle in both eyes.
11262593|NCT02653391|OG003|Outcome|Part B Elamipretide 3.0% Ophthalmic Solution|Part B Participants includes those receiving 3% Elamipretide
11262594|NCT02653391|OG000|Outcome|Part A Elamipretide 1.0% Ophthalmic Solution or Placebo|Part A participants includes those receiving 1% Elamipretide in one eye and Placebo in paired eye.
11262595|NCT02653391|OG001|Outcome|Part B Placebo|Part B Placebo includes participants who received vehicle only in both eyes.
11262596|NCT02653391|OG002|Outcome|Part B Elamipretide 3.0% Ophthalmic Solution|Part B Participants includes those receiving 3% Elamipretide in both eyes
11262597|NCT02653391|OG000|Outcome|Part A Placebo|Part A Placebo participants received vehicle in paired eye to treatment eye.
11262598|NCT02653391|OG001|Outcome|Part A Elamipretide 1.0% Ophthalmic Solution|Part A participants includes those receiving 1% Elamipretide in a randomly selected treatment eye
11262599|NCT02653391|OG000|Outcome|Part B Placebo|Part B Placebo participants received vehicle in both eyes.
11262600|NCT02653391|OG001|Outcome|Part B Elamipretide 3.0% Ophthalmic Solution|Part B participants includes those receiving 3% Elamipretide in both eyes.
11262601|NCT02653391|OG000|Outcome|Placebo Part A|"Part A: Each subject will receive one drop of vehicle ophthalmic solution BID in the fellow control eye.~Placebo A: Placebo for Part A"
11262602|NCT02653391|OG001|Outcome|Elamipretide 1.0% Ophthalmic Solution|"Cohort A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution in the randomly selected study eye BID.~Part A Elamipretide 1.0% Ophthalmic Solution: Each subject will receive one drop of Elamipretide 1.0% ophthalmic solution in the randomly selected study eye BID."
11262603|NCT02653391|OG000|Outcome|Placebo Part B|Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.
11262604|NCT02653391|OG001|Outcome|Elamipretide 3.0% Ophthalmic Solution|Part B Elamipretide 3.0% Ophthalmic Solution: Each subject will receive one drop of Elamipretide 3.0% ophthalmic solution in both eyes BID.
11262605|NCT02653391|OG000|Outcome|Placebo Eye - Pachymetry|Part A: Each subject will receive one drop of vehicle ophthalmic solution BID in the fellow control eye.
11262606|NCT02653391|OG001|Outcome|Elamipretide 1.0% Ophthalmic Solution Eye-Pachymetry|Part A Elamipretide 1.0% Ophthalmic Solution: Each subject will receive one drop of Elamipretide 1.0% ophthalmic solution in the randomly selected study eye BID.
11262607|NCT02653391|OG002|Outcome|Vehicle Eye-Pentacam|"Part A: Each subject will receive one drop of vehicle ophthalmic solution BID in the fellow control eye.~Placebo A: Placebo for Part A"
11262608|NCT02653391|OG003|Outcome|Elamipretide 1.0% Ophthalmic Solution-Pentacam|Part A Elamipretide 1.0% Ophthalmic Solution: Each subject will receive one drop of Elamipretide 1.0% ophthalmic solution in the randomly selected study eye BID.
11262609|NCT02653391|OG000|Outcome|OD-Pachymetry|Right Eye by Pachymetry
11262610|NCT02653391|OG001|Outcome|OD Pentacam|Right Eye as measured by pentacam
11262611|NCT02653391|OG002|Outcome|OS: Pachymetry|Left Eye as measured by Pachymetry
11262612|NCT02653391|OG003|Outcome|OD-Pentacam|Left Eye as measured by Pentacam
11262613|NCT02653391|OG000|Outcome|Right Eye|Right Eye Cell Hexagonality in Percentage
11262614|NCT02653391|OG001|Outcome|Left Eye|Left Eye Cell Hexagonality in Percentage
11262615|NCT02653391|OG000|Outcome|Right Eye|Subjects were randomized to receive one drop of elamipretide 3.0% topical ophthalmic solution BID in both the right and left study eyes or one drop of vehicle topical ophthalmic solution BID in both the right and left eyes.
11262616|NCT02653391|OG001|Outcome|Left Eye|Subjects were randomized to receive one drop of elamipretide 3.0% topical ophthalmic solution BID in both the right and left study eyes or one drop of vehicle topical ophthalmic solution BID in both the right and left eyes.
11262617|NCT02653391|OG000|Outcome|Right Eye|Right Eye Cell Corneal Endothelial Cell Density
11262618|NCT02653391|OG001|Outcome|Left Eye|Left Eye Cell Corneal Endothelial Cell Density
11262619|NCT02653391|OG000|Outcome|Right Eye|Right Eye Locations affected by microcysts
11262620|NCT02653391|OG001|Outcome|Left Eye|Left eye locations affected by microcysts
11262621|NCT02653391|OG000|Outcome|Part A Vehicle|Part A Placebo participants received vehicle in paired eye to treatment eye.
11262622|NCT02653391|OG001|Outcome|Elamipretide 1.0% Ophthalmic Solution|Part A participants includes those receiving 1% Elamipretide in eye paired with Placebo eye
11262623|NCT02653391|OG000|Outcome|Right Eye|Corneal Bullae in Right Eye
11262624|NCT02653391|OG001|Outcome|Left Eye|Corneal Bullae in Left Eye
11262625|NCT02653391|OG000|Outcome|Right Eye|Right Eye -Severity of Corneal Stromal Folds
11262626|NCT02653391|OG001|Outcome|Left Eye|Left Eye-Severity of Corneal Stromal Folds
11262627|NCT02653391|EG000|Reported Event|Part A Elamipretide 1.0% Ophthalmic Solution and Placebo|Part A participants includes those receiving 1% Elamipretide in one eye and placebo in other eye. This arm will report systemic events that cannot be attributed to either intervention.
11262628|NCT02653391|EG001|Reported Event|Part A Placebo Only|These will be reporting ocular AEs for placebo eye only. Part A participants includes those receiving Placebo in one eye only.
11262629|NCT02653391|EG002|Reported Event|Part A Elamipretide 1.0% Ophthalmic Solution Only|These will be reporting ocular AEs for elamipretide eye only. Part A participants includes those receiving 1% Elamipretide in one eye only.
11262630|NCT02653391|EG003|Reported Event|Part B Placebo|Part B participants includes those receiving Placebo in both eyes. This arm will be reporting ocular and systemic events.
11262631|NCT02653391|EG004|Reported Event|Part B Elamipretide 3.0% Ophthalmic Solution|Part B participants includes those receiving 3% Elamipretide in both eyes. This arm will be reporting ocular and systemic events.
11262632|NCT02653417|BG000|Baseline|Regimen 1 RAD1901 5 mg|"RAD1901 5 mg~RAD1901: RAD1901"
11262633|NCT02653417|BG001|Baseline|Regimen 2 RAD1901 10 mg|"RAD1901 10 mg~RAD1901: RAD1901"
11262634|NCT02653417|BG002|Baseline|Regimen 3 RAD1901 20 mg|"RAD1901 20 mg~RAD1901: RAD1901"
11262635|NCT02653417|BG003|Baseline|Regimen 4 Placebo|"Placebo~Placebo: Placebo"
11262636|NCT02653417|BG004|Baseline|Total|Total of all reporting groups
11262637|NCT02653417|FG000|Participant Flow|Regimen 1|"RAD1901 5 mg~RAD1901: RAD1901"
11262638|NCT02653417|FG001|Participant Flow|Regimen 2|"RAD1901 10 mg~RAD1901: RAD1901"
11262639|NCT02653417|FG002|Participant Flow|Regimen 3|"RAD1901 20 mg~RAD1901: RAD1901"
11262640|NCT02653417|FG003|Participant Flow|Regimen 4|"Placebo~Placebo: Placebo"
11262641|NCT02653417|OG000|Outcome|Regimen 1|"RAD1901 5 mg~RAD1901: RAD1901"
11262642|NCT02653417|OG001|Outcome|Regimen 2|"RAD1901 10 mg~RAD1901: RAD1901"
11262643|NCT02653417|OG002|Outcome|Regimen 3|"RAD1901 20 mg~RAD1901: RAD1901"
11262644|NCT02653417|OG003|Outcome|Regimen 4|"Placebo~Placebo: Placebo"
11262645|NCT02653417|OG000|Outcome|Regimen 1 RAD1901 5 mg|"RAD1901 5 mg~RAD1901: RAD1901"
11262646|NCT02653417|OG001|Outcome|Regimen 2 RAD1901 10 mg|"RAD1901 10 mg~RAD1901: RAD1901"
11213991|NCT02289833|OG000|Outcome|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213992|NCT02289833|OG001|Outcome|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11262647|NCT02653417|OG002|Outcome|Regimen 3 RAD1901 20 mg|"RAD1901 20 mg~RAD1901: RAD1901"
11262648|NCT02653417|OG003|Outcome|Regimen 4 Placebo|"Placebo~Placebo: Placebo"
11262649|NCT02653417|EG000|Reported Event|Regimen 1 RAD1901 5 mg|"RAD1901 5 mg~RAD1901: RAD1901"
11262650|NCT02653417|EG001|Reported Event|Regimen 2 RAD1901 10 mg|"RAD1901 10 mg~RAD1901: RAD1901"
11262651|NCT02653417|EG002|Reported Event|Regimen 3 RAD1901 20 mg|"RAD1901 20 mg~RAD1901: RAD1901"
11262652|NCT02653417|EG003|Reported Event|Regimen 4 Placebo|"Placebo~Placebo: Placebo"
11262653|NCT02653456|BG000|Baseline|RA-308 Excimer Laser and DABRA Catheter|"Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately.~RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description"
11262654|NCT02653456|FG000|Participant Flow|RA-308 Excimer Laser and DABRA Catheter|Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
11262655|NCT02653456|OG000|Outcome|RA-308 Excimer Laser and DABRA Catheter|"Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately.~RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description"
11213993|NCT02289833|OG000|Outcome|Pharmacokinetic (PK) Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213994|NCT02289833|OG000|Outcome|Anti-drug Antibody Analysis Group|Participants with HER2 IHC2 or IHC3-positive (IHC 2+ or IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213995|NCT02289833|EG000|Reported Event|Cohort IHC2+|Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11213996|NCT02289833|EG001|Reported Event|Cohort IHC3+|Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
11262656|NCT02653456|OG000|Outcome|RA-308 Excimer Laser and DABRA Catheter|"Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately.~RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description"
11262657|NCT02653456|EG000|Reported Event|RA-308 Excimer Laser and DABRA Catheter|"Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately.~RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description"
11262658|NCT02653560|BG000|Baseline|All Study Participants|Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
11262659|NCT02653560|FG000|Participant Flow|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
11262660|NCT02653560|FG001|Participant Flow|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
11262661|NCT02653560|FG002|Participant Flow|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
11262662|NCT02653560|FG003|Participant Flow|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
11262663|NCT02653560|OG000|Outcome|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
11262664|NCT02653560|OG001|Outcome|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
11262665|NCT02653560|OG002|Outcome|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
11262666|NCT02653560|OG003|Outcome|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
11262667|NCT02653560|EG000|Reported Event|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
11262668|NCT02653560|EG001|Reported Event|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
11262669|NCT02653560|EG002|Reported Event|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
11262670|NCT02653560|EG003|Reported Event|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
11262671|NCT02653625|BG000|Baseline|Cenicriviroc 150 mg|Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
11262672|NCT02653625|FG000|Participant Flow|Cenicriviroc 150 mg|Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
11262673|NCT02653625|OG000|Outcome|Cenicriviroc 150 mg|Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
11262674|NCT02653625|EG000|Reported Event|Cenicriviroc 150 mg|Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
11262675|NCT02653664|BG000|Baseline|Condition #1: PsychoEducation|"Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.~PsychoEducation: Condition #1"
11262676|NCT02653664|BG001|Baseline|Condition #2:Self-Hypnosis Training|"In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).~Self-Hypnosis Training: Condition #2"
11262677|NCT02653664|BG002|Baseline|Condition #3: Mindfulness Meditation|"In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.~Mindfulness Meditation: Condition #3"
11262678|NCT02653664|BG003|Baseline|Total|Total of all reporting groups
11262679|NCT02653664|FG000|Participant Flow|Condition #1: PsychoEducation (ED)|"Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.~PsychoEducation: Condition #1"
11262680|NCT02653664|FG001|Participant Flow|Condition #2:Self-Hypnosis Training (HYP)|"In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).~Self-Hypnosis Training: Condition #2"
11286721|NCT02891863|BG000|Baseline|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
11262681|NCT02653664|FG002|Participant Flow|Condition #3: Mindfulness Meditation (MM)|"In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.~Mindfulness Meditation: Condition #3"
11262682|NCT02653664|OG000|Outcome|Condition #1: PsychoEducation (ED)|"Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.~PsychoEducation: Condition #1"
11262683|NCT02653664|OG001|Outcome|Condition #2:Self-Hypnosis Training (HYP)|"In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).~Self-Hypnosis Training: Condition #2"
11262684|NCT02653664|OG002|Outcome|Condition #3: Mindfulness Meditation (MM)|"In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.~Mindfulness Meditation: Condition #3"
11262685|NCT02653664|OG000|Outcome|Condition #1: PsychoEducation|"Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.~PsychoEducation: Condition #1"
11262686|NCT02653664|OG001|Outcome|Condition #2:Self-Hypnosis Training|"In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).~Self-Hypnosis Training: Condition #2"
11262687|NCT02653664|OG002|Outcome|Condition #3: Mindfulness Meditation|"In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.~Mindfulness Meditation: Condition #3"
11262688|NCT02653664|EG000|Reported Event|Condition #1: PsychoEducation|"Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to.~PsychoEducation: Condition #1"
11262689|NCT02653664|EG001|Reported Event|Condition #2:Self-Hypnosis Training|"In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).~Self-Hypnosis Training: Condition #2"
11262690|NCT02653664|EG002|Reported Event|Condition #3: Mindfulness Meditation|"In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice.~Mindfulness Meditation: Condition #3"
11262691|NCT02653768|BG000|Baseline|STEP-KOA|"This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.~Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.~STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.~STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit"
11262692|NCT02653768|BG001|Baseline|Arthritis Education (AE)|The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
11262693|NCT02653768|BG002|Baseline|Total|Total of all reporting groups
11286722|NCT02891863|FG000|Participant Flow|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
11262694|NCT02653768|FG000|Participant Flow|STEP-KOA|"This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.~Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.~STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.~STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit"
11262695|NCT02653768|FG001|Participant Flow|Arthritis Education (AE)|The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
11262696|NCT02653768|OG000|Outcome|STEP-KOA|"This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.~Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.~STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.~STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit"
11262697|NCT02653768|OG001|Outcome|Arthritis Education (AE)|The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
11262698|NCT02653768|EG000|Reported Event|STEP-KOA|"This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.~Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.~STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.~STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit"
11262699|NCT02653768|EG001|Reported Event|Arthritis Education (AE)|The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
11262700|NCT02653872|BG000|Baseline|All Participants|All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
11262701|NCT02653872|FG000|Participant Flow|All Participants|All 15 participants who were enrolled in the study and who received at least a single dose of the study drug in three treatment periods in a fixed sequence and were separated by a washout period.
11262702|NCT02653872|OG000|Outcome|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11262703|NCT02653872|OG001|Outcome|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11262704|NCT02653872|OG002|Outcome|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11262705|NCT02653872|OG000|Outcome|Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11262706|NCT02653872|OG001|Outcome|Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11262707|NCT02653872|OG002|Outcome|OH-itraconazole (a Metabolite of Itraconazole)|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
11262708|NCT02653872|EG000|Reported Event|AZD7986|Participants received a single dose of AZD7986 (25 mg) administration on Day 1 (1 hour before food).
11262709|NCT02653872|EG001|Reported Event|AZD7986 + Verapamil|Participants received Verapamil (240 mg; extended release formulation) administered daily (1 hour before food) on Days 1 to 10 plus administration of a single dose of AZD7986 (25 mg) on Day 5 (1 hour before food).
11262710|NCT02653872|EG002|Reported Event|AZD7986 + Itraconazole|Participants received Itraconazole (200 mg; oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily on Days 2 to 11 (1 hour before food) plus administration of AZD7986 (25 mg) as a single dose on Day 6 (1 hour before food).
10820344|NCT00057330|OG001|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262711|NCT02653872|EG003|Reported Event|Verapamil|Participants received Verapamil
11262712|NCT02653872|EG004|Reported Event|Itraconazole|Participants received Itraconazole.
11262713|NCT02653872|EG005|Reported Event|All Subjects|Overall number of participants in the study.
11262714|NCT02654002|BG000|Baseline|Cohort 1: Cilofexor 10 mg|Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11213997|NCT02289898|BG000|Baseline|Placebo/Placebo Arm|Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11213998|NCT02289898|BG001|Baseline|Demcizumab/Placebo Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11213999|NCT02289898|BG002|Baseline|Demcizumab/Demcizumab Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214000|NCT02289898|BG003|Baseline|Total|Total of all reporting groups
11214001|NCT02289898|FG000|Participant Flow|Placebo/Placebo Arm|Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214002|NCT02289898|FG001|Participant Flow|Demcizumab/Placebo Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214003|NCT02289898|FG002|Participant Flow|Demcizumab/Demcizumab Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214004|NCT02289898|OG000|Outcome|Placebo/Placebo Arm|Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214005|NCT02289898|OG001|Outcome|Demcizumab/Placebo and Demcizumab/Demcizumab|"Pooled demcizumab arms: Demcizumab/placebo arm - Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.~Demcizumab/demcizumab arn - Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression."
11214006|NCT02289898|EG000|Reported Event|Placebo/Placebo Arm|Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214007|NCT02289898|EG001|Reported Event|Demcizumab/Placebo Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214008|NCT02289898|EG002|Reported Event|Demcizumab/Demcizumab Arm|Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.
11214009|NCT02289950|BG000|Baseline|Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (area under the concentration-time curve [AUC] 5) plus paclitaxel 175 milligrams per square meter (mg/m^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
11214010|NCT02289950|BG001|Baseline|Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
11214011|NCT02289950|BG002|Baseline|Total|Total of all reporting groups
11214012|NCT02289950|FG000|Participant Flow|Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (area under the concentration-time curve [AUC] 5) plus paclitaxel 175 milligrams per square meter (mg/m^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
11214013|NCT02289950|FG001|Participant Flow|Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
11262715|NCT02654002|BG001|Baseline|Cohort 2: Cilofexor 30 mg|Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
11262716|NCT02654002|BG002|Baseline|Cohort 3: Cilofexor 100 mg|Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
11262717|NCT02654002|BG003|Baseline|Cohort 4: Cilofexor 300 mg|Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
11262718|NCT02654002|BG004|Baseline|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262719|NCT02654002|BG005|Baseline|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262720|NCT02654002|BG006|Baseline|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262721|NCT02654002|BG007|Baseline|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262722|NCT02654002|BG008|Baseline|All Placebo|Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262723|NCT02654002|BG009|Baseline|Total|Total of all reporting groups
11262724|NCT02654002|FG000|Participant Flow|Cohort 1: Cilofexor 10 mg|Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262725|NCT02654002|FG001|Participant Flow|Cohort 2: Cilofexor 30 mg|Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
11262726|NCT02654002|FG002|Participant Flow|Cohort 3: Cilofexor 100 mg|Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
11262727|NCT02654002|FG003|Participant Flow|Cohort 4: Cilofexor 300 mg|Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
11262728|NCT02654002|FG004|Participant Flow|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262729|NCT02654002|FG005|Participant Flow|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262730|NCT02654002|FG006|Participant Flow|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262731|NCT02654002|FG007|Participant Flow|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262732|NCT02654002|FG008|Participant Flow|All Placebo|Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262733|NCT02654002|OG000|Outcome|Cohort 1: Cilofexor 10 mg|Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262734|NCT02654002|OG001|Outcome|Cohort 2: Cilofexor 30 mg|Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
11262735|NCT02654002|OG002|Outcome|Cohort 3: Cilofexor 100 mg|Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
11262736|NCT02654002|OG003|Outcome|Cohort 4: Cilofexor 300 mg|Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
11262737|NCT02654002|OG004|Outcome|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262738|NCT02654002|OG005|Outcome|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262739|NCT02654002|OG006|Outcome|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262740|NCT02654002|OG007|Outcome|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262741|NCT02654002|OG008|Outcome|All Placebo|Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262742|NCT02654002|OG000|Outcome|Cohort 1: Cilofexor 10 mg|Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262743|NCT02654002|OG001|Outcome|Cohort 2: Cilofexor 30 mg|Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
11262744|NCT02654002|OG002|Outcome|Cohort 3: Cilofexor 100 mg|Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
11262745|NCT02654002|OG003|Outcome|Cohort 4: Cilofexor 300 mg|Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
11262746|NCT02654002|OG004|Outcome|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262747|NCT02654002|OG005|Outcome|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262748|NCT02654002|OG006|Outcome|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262749|NCT02654002|OG007|Outcome|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262750|NCT02654002|OG008|Outcome|All Placebo|Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then receive placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262751|NCT02654002|OG004|Outcome|All Fasted Placebo|Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
11262752|NCT02654002|OG005|Outcome|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262753|NCT02654002|OG006|Outcome|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262754|NCT02654002|OG007|Outcome|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262755|NCT02654002|OG008|Outcome|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262756|NCT02654002|OG009|Outcome|All Fed Placebo|Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262757|NCT02654002|EG000|Reported Event|Cohort 1: Cilofexor 10 mg|Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262758|NCT02654002|EG001|Reported Event|Cohort 2: Cilofexor 30 mg|Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
11262759|NCT02654002|EG002|Reported Event|Cohort 3: Cilofexor 100 mg|Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
11262760|NCT02654002|EG003|Reported Event|Cohort 4: Cilofexor 300 mg|Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
11262761|NCT02654002|EG004|Reported Event|Cohort 5: Cilofexor 100 mg|Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
11262762|NCT02654002|EG005|Reported Event|Cohort 6: Cilofexor 50 mg|Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
11262763|NCT02654002|EG006|Reported Event|Cohort 7: Cilofexor 15 mg|Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
11262764|NCT02654002|EG007|Reported Event|Cohort 8: Cilofexor 10 mg|Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
11262765|NCT02654002|EG008|Reported Event|All Placebo|Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
11262766|NCT02654054|BG000|Baseline|Placebo|Placebo for both elagolix BID and E2/NETA QD
11262767|NCT02654054|BG001|Baseline|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262768|NCT02654054|BG002|Baseline|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262769|NCT02654054|BG003|Baseline|Total|Total of all reporting groups
11262770|NCT02654054|FG000|Participant Flow|Placebo|Placebo for both elagolix BID and E2/NETA QD
11262771|NCT02654054|FG001|Participant Flow|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262772|NCT02654054|FG002|Participant Flow|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262773|NCT02654054|OG000|Outcome|Placebo|Placebo for both elagolix BID and E2/NETA QD
11262774|NCT02654054|OG001|Outcome|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262775|NCT02654054|OG002|Outcome|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262776|NCT02654054|OG002|Outcome|Elagolix + Estradiol/Norethindrone Acetate|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262777|NCT02654054|EG000|Reported Event|Placebo|Placebo for both elagolix BID and E2/NETA QD
11262778|NCT02654054|EG001|Reported Event|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262779|NCT02654054|EG002|Reported Event|Elagolix + E2-NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11262780|NCT02654145|BG000|Baseline|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11262781|NCT02654145|FG000|Participant Flow|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11262782|NCT02654145|OG000|Outcome|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11262783|NCT02654145|EG000|Reported Event|Mepolizumab 100 mg SC|Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
11262784|NCT02654483|BG000|Baseline|5 mg VPD-737|"5 mg tablets of VPD-737 to be taken daily by mouth for 56 days~VPD-737: VPD-737 inhibits the receptor neurokinin-1."
11262785|NCT02654483|BG001|Baseline|Placebo|"Placebo tablets to be taken daily by mouth for 56 days~Placebo: Matching tablets to VPD-737 tablets without active drug"
11262786|NCT02654483|BG002|Baseline|Total|Total of all reporting groups
11262787|NCT02654483|FG000|Participant Flow|5 mg VPD-737|"5 mg tablets of VPD-737 to be taken daily by mouth for 56 days~VPD-737: VPD-737 inhibits the receptor neurokinin-1."
11262788|NCT02654483|FG001|Participant Flow|Placebo|"Placebo tablets to be taken daily by mouth for 56 days~Placebo: Matching tablets to VPD-737 tablets without active drug"
11262789|NCT02654483|OG000|Outcome|5 mg VPD-737|7 subjects were treated with active drug
11262790|NCT02654483|OG001|Outcome|Placebo|7 subjects were treated with placebo
11262791|NCT02654483|OG000|Outcome|5 mg VPD-737|"5 mg tablets of VPD-737 to be taken daily by mouth for 56 days~VPD-737: VPD-737 inhibits the receptor neurokinin-1."
11262792|NCT02654483|OG001|Outcome|Placebo|"Placebo tablets to be taken daily by mouth for 56 days~Placebo: Matching tablets to VPD-737 tablets without active drug"
11262793|NCT02654483|OG000|Outcome|5 mg VPD-737|5 mg tablets of VPD-737 to be taken daily by mouth for 56 days
11262794|NCT02654483|OG001|Outcome|Placebo|Placebo tablets to be taken daily by mouth for 56 days
11262795|NCT02654483|EG000|Reported Event|Double-blind, 5 mg VPD-737|"5 mg tablets of VPD-737 to be taken daily by mouth for 56 days~VPD-737: VPD-737 inhibits the receptor neurokinin-1."
11262796|NCT02654483|EG001|Reported Event|Double-blind, Placebo|"Placebo tablets to be taken daily by mouth for 56 days~Placebo: Matching tablets to VPD-737 tablets without active drug"
11262797|NCT02654483|EG002|Reported Event|Open-label, 5 mg VPD-737 - 5 mg VPD-737|5 mg tablets of VPD-737 to be taken daily by mouth for 56 days, followed by a wash out period and, 5 mg tablets of VPD-737 to be taken daily by mouth for 2 months.
11262798|NCT02654483|EG003|Reported Event|Open-label, Placebo - 5 mg VPD-737|Placebo tablets to be taken daily by mouth for 56 days, followed by a wash out period and, 5 mg tablets of VPD-737 to be taken daily by mouth for 2 months.
11262799|NCT02654652|BG000|Baseline|Symbiotic|Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.
11262800|NCT02654652|BG001|Baseline|Maltodextrin|Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
11262801|NCT02654652|BG002|Baseline|Total|Total of all reporting groups
11262802|NCT02654652|FG000|Participant Flow|Symbiotic|"Patients will receive twice a day the symbiotic product during seven days after surgical treatment~LactoFos: Patients will receive the product twice a day during seven days after surgical treatment"
11262803|NCT02654652|FG001|Participant Flow|Maltodextrin|"Patients will receive twice a day the placebo product during seven days after surgical treatment~Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment"
11262804|NCT02654652|OG000|Outcome|Symbiotic|Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.
11262805|NCT02654652|OG001|Outcome|Maltodextrin|Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
11262806|NCT02654652|EG000|Reported Event|Symbiotic|Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.
11262807|NCT02654652|EG001|Reported Event|Maltodextrin|Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
11262808|NCT02654691|BG000|Baseline|Chemotherapy|Patients treated with docetaxel or oxaliplatin.
11262809|NCT02654691|FG000|Participant Flow|Chemotherapy|Patients treated with docetaxel or oxaliplatin.
11262810|NCT02654691|OG000|Outcome|Chemotherapy|Patients treated with docetaxel or oxaliplatin.
11262811|NCT02654691|EG000|Reported Event|Chemotherapy|There were no adverse events
11262812|NCT02654717|BG000|Baseline|DFD-07 Cream|"DFD-07 cream applied twice daily~DFD-07 Cream"
11262813|NCT02654717|BG001|Baseline|Placebo Cream|"Placebo cream applied twice daily~Placebo Cream"
11262814|NCT02654717|BG002|Baseline|Total|Total of all reporting groups
11262815|NCT02654717|FG000|Participant Flow|DFD-07 Cream|"DFD-07 cream applied twice daily~DFD-07 Cream"
11262816|NCT02654717|FG001|Participant Flow|Placebo Cream|"Placebo cream applied twice daily~Placebo Cream"
11262817|NCT02654717|OG000|Outcome|DFD-07|Patients treated with DFD07 for 8 weeks
11262818|NCT02654717|OG001|Outcome|Vehicle|Pts treated with vehicle for 8 weeks
11262819|NCT02654717|EG000|Reported Event|DFD-07 Cream|"DFD-07 cream applied twice daily~DFD-07 Cream"
11262820|NCT02654717|EG001|Reported Event|Placebo Cream|"Placebo cream applied twice daily~Placebo Cream"
11262821|NCT02654769|BG000|Baseline|Active Comparator Picato®|"Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11262822|NCT02654769|BG001|Baseline|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.05% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11262823|NCT02654769|BG002|Baseline|Vehicle Foam|"Vehicle gel of the test product~Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11262824|NCT02654769|BG003|Baseline|Total|Total of all reporting groups
11262825|NCT02654769|FG000|Participant Flow|Active Comparator Picato®|"Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11262826|NCT02654769|FG001|Participant Flow|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.05% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11262827|NCT02654769|FG002|Participant Flow|Vehicle Foam|"Vehicle gel of the test product~Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11262828|NCT02654769|OG000|Outcome|Active Comparator Picato®|"Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11262829|NCT02654769|OG001|Outcome|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.05% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11262830|NCT02654769|OG002|Outcome|Vehicle Foam|"Vehicle gel of the test product~Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11262831|NCT02654769|EG000|Reported Event|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.05% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11262832|NCT02654769|EG001|Reported Event|Active Comparator Picato®|"Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11262833|NCT02654769|EG002|Reported Event|Vehicle Foam|"Vehicle gel of the test product~Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11262834|NCT02654808|BG000|Baseline|Standard Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262835|NCT02654808|BG001|Baseline|Standard Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262836|NCT02654808|BG002|Baseline|AirSeal Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262837|NCT02654808|BG003|Baseline|AirSeal Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262838|NCT02654808|BG004|Baseline|Total|Total of all reporting groups
11262839|NCT02654808|FG000|Participant Flow|Standard Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262840|NCT02654808|FG001|Participant Flow|Standard Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262841|NCT02654808|FG002|Participant Flow|AirSeal Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262842|NCT02654808|FG003|Participant Flow|AirSeal Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262843|NCT02654808|OG000|Outcome|Standard Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262844|NCT02654808|OG001|Outcome|Standard Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262845|NCT02654808|OG002|Outcome|AirSeal Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262846|NCT02654808|OG003|Outcome|AirSeal Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262847|NCT02654808|OG000|Outcome|Standard 10|Standard insufflation system 10mmHg
11262848|NCT02654808|OG001|Outcome|Standard 15|standard insufflation system 15 mmHg
11262849|NCT02654808|OG002|Outcome|Valveless 10|Valveless insufflation system 10 mmHg
11262850|NCT02654808|OG003|Outcome|Valveless 15|Valveless insufflation system 15 mmHg
11262851|NCT02654808|EG000|Reported Event|Standard Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262852|NCT02654808|EG001|Reported Event|Standard Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
11262853|NCT02654808|EG002|Reported Event|AirSeal Trocar/ IAP 15 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11337455|NCT03585712|FG002|Participant Flow|Arm B: Missed Then Delayed Pill|"Treatment period 2, visit Day 42+/- 3 days: missed pill of Norgestrel 75 mcg Treatment period 3, visit Day 70+/-3 days: 6 hour delayed intake of the pill of Norgestrel 75 mcg~Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3"
11214014|NCT02289950|OG000|Outcome|Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (area under the concentration-time curve [AUC] 5) plus paclitaxel 175 milligrams per square meter (mg/m^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
11214015|NCT02289950|OG001|Outcome|Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
11214016|NCT02289950|EG000|Reported Event|Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (area under the concentration-time curve [AUC] 5) plus paclitaxel 175 milligrams per square meter (mg/m^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason.
11214017|NCT02289950|EG001|Reported Event|Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD|Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
11214018|NCT02289963|BG000|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
11214019|NCT02289963|BG001|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11214020|NCT02289963|BG002|Baseline|Total|Total of all reporting groups
11214021|NCT02289963|FG000|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
11214022|NCT02289963|FG001|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11214023|NCT02289963|OG000|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
11214024|NCT02289963|OG001|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
11214025|NCT02289963|EG000|Reported Event|Placebo Q2W|Participants exposed to Placebo (for Alirocumab) SC injection Q2W added to stable LMT (mean exposure of 23 weeks).
11214026|NCT02289963|EG001|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable LMT (mean exposure of 24 weeks).
11214027|NCT02289989|BG000|Baseline|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214028|NCT02289989|BG001|Baseline|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214029|NCT02289989|BG002|Baseline|Total|Total of all reporting groups
11214030|NCT02289989|FG000|Participant Flow|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214031|NCT02289989|FG001|Participant Flow|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214032|NCT02289989|OG000|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11262854|NCT02654808|EG003|Reported Event|AirSeal Trocar/ IAP 10 mmHg|"Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.~AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
11262855|NCT02654860|BG000|Baseline|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262856|NCT02654860|BG001|Baseline|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262857|NCT02654860|BG002|Baseline|120 mg Paracetamol 3% (4mL)|"120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262858|NCT02654860|BG003|Baseline|Phase II Only: Saline Solution 0.9%|"Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.~Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262859|NCT02654860|BG004|Baseline|Total|Total of all reporting groups
11262860|NCT02654860|FG000|Participant Flow|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262861|NCT02654860|FG001|Participant Flow|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262862|NCT02654860|FG002|Participant Flow|120 mg Paracetamol 3% (4mL)|"120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262863|NCT02654860|FG003|Participant Flow|Phase II Only: Saline Solution 0.9%|"Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.~Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262864|NCT02654860|OG000|Outcome|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262865|NCT02654860|OG001|Outcome|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262866|NCT02654860|OG002|Outcome|120 mg Paracetamol 3% (4mL)|"120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262867|NCT02654860|OG003|Outcome|Phase II Only: Saline Solution 0.9%|"Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.~Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262868|NCT02654860|EG000|Reported Event|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262869|NCT02654860|EG001|Reported Event|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262870|NCT02654860|EG002|Reported Event|120 mg Paracetamol 3% (4mL)|"120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route.~Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262871|NCT02654860|EG003|Reported Event|Phase II Only: Saline Solution 0.9%|"Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %.~Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.~Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure"
11262872|NCT02654977|BG000|Baseline|Metreleptin|"Metreleptin open-label~Metreleptin: MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections"
11262873|NCT02654977|FG000|Participant Flow|Metreleptin|"Metreleptin open-label~Metreleptin: MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections"
11262874|NCT02654977|OG000|Outcome|Metreleptin|"Metreleptin open-label~Metreleptin: MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections"
11262875|NCT02654977|EG000|Reported Event|Metreleptin|"Metreleptin open-label~Metreleptin: MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections"
11262876|NCT02655224|BG000|Baseline|Relugolix 40 mg|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
11262877|NCT02655224|BG001|Baseline|Placebo|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
11262878|NCT02655224|BG002|Baseline|Total|Total of all reporting groups
11262879|NCT02655224|FG000|Participant Flow|Relugolix 40 mg|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
11262880|NCT02655224|FG001|Participant Flow|Placebo|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
11262881|NCT02655224|OG000|Outcome|Relugolix 40 mg|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
11262882|NCT02655224|OG001|Outcome|Placebo|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
11262883|NCT02655224|EG000|Reported Event|Relugolix 40 mg|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
11262884|NCT02655224|EG001|Reported Event|Placebo|Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
11262885|NCT02655237|BG000|Baseline|Relugolix 40 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period.
11262886|NCT02655237|BG001|Baseline|Leuprorelin 1.88 mg or 3.75 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period.
11262887|NCT02655237|BG002|Baseline|Total|Total of all reporting groups
11262888|NCT02655237|FG000|Participant Flow|Relugolix 40 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period.
11262889|NCT02655237|FG001|Participant Flow|Leuprorelin 1.88 mg or 3.75 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period.
11262890|NCT02655237|OG000|Outcome|Relugolix 40 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period.
11262891|NCT02655237|OG001|Outcome|Leuprorelin 1.88 mg or 3.75 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period.
11262892|NCT02655237|EG000|Reported Event|Relugolix 40 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period.
11262893|NCT02655237|EG001|Reported Event|Leuprorelin 1.88 mg or 3.75 mg|Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period.
11262894|NCT02655354|BG000|Baseline|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Care Management~Fluoxetine: Anti-depressant~Fluvoxamine: Anti-depressant~Paroxetine: Anti-depressant~Sertraline: Anti-depressant~Citalopram: Anti-depressant~Venlafaxine: Anti-depressant~Duloxetine: Anti-depressant~Mirtazapine: Anti-depressant~Diphenhydramine: Sleep medication~Trazodone: Sleep medication~Prazosin: Sleep medication"
11262895|NCT02655354|BG001|Baseline|Usual Care|Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
11262896|NCT02655354|BG002|Baseline|Total|Total of all reporting groups
11262897|NCT02655354|FG000|Participant Flow|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Care Management~Fluoxetine: Anti-depressant~Fluvoxamine: Anti-depressant~Paroxetine: Anti-depressant~Sertraline: Anti-depressant~Citalopram: Anti-depressant~Venlafaxine: Anti-depressant~Duloxetine: Anti-depressant~Mirtazapine: Anti-depressant~Diphenhydramine: Sleep medication~Trazodone: Sleep medication~Prazosin: Sleep medication"
11262898|NCT02655354|FG001|Participant Flow|Usual Care|Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
11262899|NCT02655354|OG000|Outcome|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Care Management~Fluoxetine: Anti-depressant~Fluvoxamine: Anti-depressant~Paroxetine: Anti-depressant~Sertraline: Anti-depressant~Citalopram: Anti-depressant~Venlafaxine: Anti-depressant~Duloxetine: Anti-depressant~Mirtazapine: Anti-depressant~Diphenhydramine: Sleep medication~Trazodone: Sleep medication~Prazosin: Sleep medication"
11262900|NCT02655354|OG001|Outcome|Usual Care|Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
11262901|NCT02655354|EG000|Reported Event|Intervention|"The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Care Management~Fluoxetine: Anti-depressant~Fluvoxamine: Anti-depressant~Paroxetine: Anti-depressant~Sertraline: Anti-depressant~Citalopram: Anti-depressant~Venlafaxine: Anti-depressant~Duloxetine: Anti-depressant~Mirtazapine: Anti-depressant~Diphenhydramine: Sleep medication~Trazodone: Sleep medication~Prazosin: Sleep medication"
11262902|NCT02655354|EG001|Reported Event|Usual Care|Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
11262903|NCT02655419|BG000|Baseline|ATM-AVI+ Metronidazole:Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (CrCl > 50 mL/min), received IV infusion of 500 mg ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11286723|NCT02891863|OG000|Outcome|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
10820345|NCT00057330|EG000|Reported Event|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262904|NCT02655419|BG001|Baseline|ATM-AVI + Metronidazole: High AVI Dose Cohort|Participants received ATM-AVI IV infusion in following manner (1. normal renal function or mild renal impairment [CrCl >50mL/min] : 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 500 mg AVI, over a 3 hour period every 6 hours; 2. moderate renal impairment [CrCl 31-50 ml/min]: 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by IV extended loading infusion of 1500 mg ATM plus 500 mg AVI over 3 hour, followed by maintenance infusions of 750 mg ATM plus 250 mg AVI, over 3 hour period every 6 hours) along with 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion. All treatments were administered for minimum 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262905|NCT02655419|BG002|Baseline|Total|Total of all reporting groups
11262906|NCT02655419|FG000|Participant Flow|Aztreonam-Avibactam(ATM-AVI)+Metronidazole:Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (Creatinine clearance [CrCl] greater than[>] 50 milliliter per minute [mL/min]), received intravenous (IV) infusion of 500 milligram (mg) ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262907|NCT02655419|FG001|Participant Flow|ATM-AVI + Metronidazole: High AVI Dose Cohort|Participants received ATM-AVI IV infusion in following manner (1. normal renal function or mild renal impairment [CrCl >50mL/min] : 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 500 mg AVI, over a 3 hour period every 6 hours; 2. moderate renal impairment [CrCl 31-50 ml/min]: 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by IV extended loading infusion of 1500 mg ATM plus 500 mg AVI over 3 hour, followed by maintenance infusions of 750 mg ATM plus 250 mg AVI, over 3 hour period every 6 hours) along with 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion. All treatments were administered for minimum 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262908|NCT02655419|OG000|Outcome|ATM-AVI+ Metronidazole:Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (CrCl > 50 mL/min), received IV infusion of 500 mg ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262909|NCT02655419|OG001|Outcome|ATM-AVI + Metronidazole: High AVI Dose Cohort|Participants received ATM-AVI IV infusion in following manner (1. normal renal function or mild renal impairment [CrCl >50mL/min] : 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 500 mg AVI, over a 3 hour period every 6 hours; 2. moderate renal impairment [CrCl 31-50 ml/min]: 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by IV extended loading infusion of 1500 mg ATM plus 500 mg AVI over 3 hour, followed by maintenance infusions of 750 mg ATM plus 250 mg AVI, over 3 hour period every 6 hours) along with 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion. All treatments were administered for minimum 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262910|NCT02655419|OG000|Outcome|ATM-AVI + Metronidazole: Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (CrCl > 50 mL/min), received IV infusion of 500 mg ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262911|NCT02655419|OG000|Outcome|ATM-AVI + Metronidazole: High AVI Dose Cohort|Participants received ATM-AVI IV infusion in following manner (1. normal renal function or mild renal impairment [CrCl >50mL/min] : 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 500 mg AVI, over a 3 hour period every 6 hours; 2. moderate renal impairment [CrCl 31-50 ml/min]: 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by IV extended loading infusion of 1500 mg ATM plus 500 mg AVI over 3 hour, followed by maintenance infusions of 750 mg ATM plus 250 mg AVI, over 3 hour period every 6 hours) along with 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion. All treatments were administered for minimum 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262912|NCT02655419|OG001|Outcome|Higher AVI Dose (Cohorts 2+3)|Participants with cIAI, having CrCl >50mL/min, received ATM plus AVI at loading dose of 500mg ATM plus higher dose AVI(167mg), IV for 30minute period, followed by maintenance infusions of 1500mg ATM plus 500mg AVI, over 3hr period every 6hrs, for maximum of 14days. Participants with CrCl 31-50mL/min, either received loading dose consistent with Cohort 1, followed by extended loading infusion of 1500mg ATM plus 410mg AVI over 3hr period, followed by(3hrs after stop of second loading infusion) maintenance infusion of 750mg ATM plus 205mg AVI over 3hr period(administered every 6hrs) or loading dose consistent with higher AVI dose in Cohort 2, followed by extended loading infusion of 1500mg ATM plus 500mg AVI over 3hrperiod, followed by maintenance infusion of 750mg ATM plus 250mg AVI over 3hr period(administered every 6hrs). Participants also received 500mg metronidazole infused over 1hr every 8hrs after first ATM-AVI maintenance infusion(Day5 to Day14) at investigator's discretion.
11262913|NCT02655419|OG000|Outcome|ATM-AVI+ Metronidazole: Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (CrCl > 50 mL/min), received IV infusion of 500 mg ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262914|NCT02655419|EG000|Reported Event|ATM-AVI+ Metronidazole: Low AVI Dose Cohort|Participants with normal renal function or mild renal impairment (CrCl > 50 mL/min), received IV infusion of 500 mg ATM plus 137 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 410 mg AVI, over a 3 hour period every 6 hours, for a minimum of 5 days and up to maximum of 14 days. Participants also received 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion for a minimum of 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262915|NCT02655419|EG001|Reported Event|ATM-AVI + Metronidazole: High AVI Dose Cohort|Participants received ATM-AVI IV infusion in following manner (1. normal renal function or mild renal impairment [CrCl >50mL/min] : 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by maintenance infusions of 1500 mg ATM plus 500 mg AVI, over a 3 hour period every 6 hours; 2. moderate renal impairment [CrCl 31-50 ml/min]: 500 mg ATM plus 167 mg AVI over 30 minutes as loading dose, followed by IV extended loading infusion of 1500 mg ATM plus 500 mg AVI over 3 hour, followed by maintenance infusions of 750 mg ATM plus 250 mg AVI, over 3 hour period every 6 hours) along with 1 hour IV infusion of 500 mg metronidazole, every 8 hrs after first ATM-AVI maintenance infusion. All treatments were administered for minimum 5 days and up to maximum of 14 days. All study therapies could be discontinued (after at least 5 full days of IV therapy) at the discretion of the investigator.
11262916|NCT02655510|BG000|Baseline|Period 1: F-652 10 μg/kg|Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262917|NCT02655510|BG001|Baseline|Period 2: F-652 30 μg/kg|Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion
11262918|NCT02655510|BG002|Baseline|Period 3: F-652 45 μg/kg|Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262919|NCT02655510|BG003|Baseline|Total|Total of all reporting groups
11262920|NCT02655510|FG000|Participant Flow|Period 1: F-652 10 μg/kg|Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262921|NCT02655510|FG001|Participant Flow|Period 2: F-652 30 μg/kg|Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262922|NCT02655510|FG002|Participant Flow|Period 3: F-652 45 μg/kg|Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262923|NCT02655510|OG000|Outcome|Period 1: F-652 10 μg/kg|Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262924|NCT02655510|OG001|Outcome|Period 2: F-652 30 μg/kg|Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262925|NCT02655510|OG002|Outcome|Period 3: F-652 45 μg/kg|Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262926|NCT02655510|EG000|Reported Event|Period 1: F-652 10 μg/kg|Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262927|NCT02655510|EG001|Reported Event|Period 2: F-652 30 μg/kg|Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
10820346|NCT00057330|EG001|Reported Event|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
11262928|NCT02655510|EG002|Reported Event|Period 3: F-652 45 μg/kg|Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
11262929|NCT02655653|BG000|Baseline|Epsilon-aminocaproic Acid (EACA)|"Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr.~Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262930|NCT02655653|BG001|Baseline|Tranexamic Acid (TA)|"Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion.~Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262931|NCT02655653|BG002|Baseline|Total|Total of all reporting groups
11286724|NCT02891863|EG000|Reported Event|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.~LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
10820347|NCT00057551|BG000|Baseline|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
10820348|NCT00057551|BG001|Baseline|Brief Supportive P|Brief Supportive Psychotherapyherapy
10820349|NCT00057551|BG002|Baseline|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
11262932|NCT02655653|FG000|Participant Flow|Epsilon-aminocaproic Acid (EACA)|"Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr.~Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262933|NCT02655653|FG001|Participant Flow|Tranexamic Acid (TA)|"Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion.~Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262934|NCT02655653|OG000|Outcome|Epsilon-aminocaproic Acid (EACA)|"Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr.~Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262935|NCT02655653|OG001|Outcome|Tranexamic Acid (TA)|"Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion.~Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262936|NCT02655653|OG000|Outcome|Epsilon-aminocaproic Acid (EACA)|How many subjects had a myocardial infarction?
11262937|NCT02655653|OG001|Outcome|Tranexamic Acid (TA)|How many subjects had a myocardial infarction?
11262938|NCT02655653|OG000|Outcome|Epsilon-aminocaproic Acid (EACA)|How many subjects were reoperated on?
11262939|NCT02655653|OG001|Outcome|Tranexamic Acid (TA)|How many subjects were reoperated on?
11262940|NCT02655653|OG000|Outcome|Epsilon-aminocaproic Acid (EACA)|How many subjects passed away?
11262941|NCT02655653|OG001|Outcome|Tranexamic Acid (TA)|How many subjects passed away?
11262942|NCT02655653|EG000|Reported Event|Epsilon-aminocaproic Acid (EACA)|"Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr.~Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
11262943|NCT02655653|EG001|Reported Event|Tranexamic Acid (TA)|"Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion.~Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin."
10820350|NCT00057551|BG003|Baseline|Total|Total of all reporting groups
10820351|NCT00057551|FG000|Participant Flow|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
10820352|NCT00057551|FG001|Participant Flow|BriefSP|Brief Supportive Psychotherapy
11262944|NCT02655666|BG000|Baseline|Medtronic MiniMed Paradigm® REAL-Time System|Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
11262945|NCT02655666|FG000|Participant Flow|Medtronic MiniMed Paradigm® REAL-Time System|Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
11262946|NCT02655666|OG000|Outcome|Medtronic MiniMed Paradigm® REAL-Time System|Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
11262947|NCT02655666|EG000|Reported Event|Medtronic MiniMed Paradigm® REAL-Time System|Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor
11262948|NCT02655679|BG000|Baseline|VTP- 38543 0.05%|VTP-38543 0.05% administered topically every 12 hours for 28 days.
11262949|NCT02655679|BG001|Baseline|VTP- 38543 0.15%|VTP-38543 0.15% administered topically every 12 hours for 28 days.
11262950|NCT02655679|BG002|Baseline|Vehicle Without Transcutol®P|Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
11262951|NCT02655679|BG003|Baseline|VTP-38543 1%|VTP-38543 1% administered topically every 12 hours for 28 days.
11262952|NCT02655679|BG004|Baseline|Vehicle With Transcutol®P|Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
11262953|NCT02655679|BG005|Baseline|Total|Total of all reporting groups
11262954|NCT02655679|FG000|Participant Flow|VTP- 38543 0.05%|VTP-38543 0.05% administered topically every 12 hours for 28 days.
11262955|NCT02655679|FG001|Participant Flow|VTP- 38543 0.15%|VTP-38543 0.15% administered topically every 12 hours for 28 days.
11262956|NCT02655679|FG002|Participant Flow|Vehicle Without Transcutol®P|Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
11262957|NCT02655679|FG003|Participant Flow|VTP-38543 1%|VTP-38543 1% administered topically every 12 hours for 28 days.
11262958|NCT02655679|FG004|Participant Flow|Vehicle With Transcutol®P|Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
11262959|NCT02655679|OG000|Outcome|VTP-38543 0.05%|VTP-38543 0.05% administered topically every 12 hours for 28 days.
11262960|NCT02655679|OG001|Outcome|VTP-38543 0.15%|VTP-38543 0.15% administered topically every 12 hours for 28 days.
11262961|NCT02655679|OG002|Outcome|Vehicle Without Transcutol®P|Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
11262962|NCT02655679|OG003|Outcome|VTP-38543 1%|VTP-38543 1% administered topically every 12 hours for 28 days.
11262963|NCT02655679|OG004|Outcome|Vehicle With Transcutol®P|Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
11262964|NCT02655679|OG002|Outcome|VTP-38543 1%|VTP-38543 1% administered topically every 12 hours for 28 days.
11262965|NCT02655679|EG000|Reported Event|VTP- 38543 0.05%|VTP-38543 0.05% administered topically every 12 hours for 28 days.
11262966|NCT02655679|EG001|Reported Event|VTP- 38543 0.15%|VTP-38543 0.15% administered topically every 12 hours for 28 days.
11262967|NCT02655679|EG002|Reported Event|Vehicle Without Transcutol®P|Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
11262968|NCT02655679|EG003|Reported Event|VTP-38543 1%|VTP-38543 1% administered topically every 12 hours for 28 days.
11262969|NCT02655679|EG004|Reported Event|Vehicle With Transcutol®P|Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
11262970|NCT02655887|BG000|Baseline|VENOVO™ Venous Stent.|"Implant of the VENOVO™ Venous Stent~VENOVO™ Venous Stent: VENOVO™ Venous stent placement"
11262971|NCT02655887|FG000|Participant Flow|VENOVO™ Venous Stent.|"Implant of the VENOVO™ Venous Stent~VENOVO™ Venous Stent: VENOVO™ Venous stent placement"
11262972|NCT02655887|OG000|Outcome|VENOVO™ Venous Stent.|"Implant of the VENOVO™ Venous Stent~VENOVO™ Venous Stent: VENOVO™ Venous stent placement"
11262973|NCT02655887|EG000|Reported Event|VENOVO™ Venous Stent.|"Implant of the VENOVO™ Venous Stent~VENOVO™ Venous Stent: VENOVO™ Venous stent placement"
11262974|NCT02656069|BG000|Baseline|G-Pen First, Then Lilly Glucagon|"A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])~G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector~Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder"
11262975|NCT02656069|BG001|Baseline|Lilly Glucagon First, Then G-Pen|"A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)~Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder~G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector"
11262976|NCT02656069|BG002|Baseline|Total|Total of all reporting groups
11262977|NCT02656069|FG000|Participant Flow|G-Pen First, Then Lilly Glucagon|"A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])~G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector~Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder"
11262978|NCT02656069|FG001|Participant Flow|Lilly Glucagon First, Then G-Pen|"A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)~Lilly Glucagon (glucagon injection [rDNA origin]): 1 mg of Lilly glucagon reconstituted from lyophilized powder~G-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector"
11262979|NCT02656069|OG000|Outcome|G-Pen|A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
11262980|NCT02656069|OG001|Outcome|Lilly Glucagon|A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
11262981|NCT02656069|EG000|Reported Event|G-Pen|A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)
11262982|NCT02656069|EG001|Reported Event|Lilly Glucagon|A single 1 mg subcutaneous (SC) injection of Lilly Glucagon
11262983|NCT02656160|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11262984|NCT02656160|FG000|Participant Flow|4-AP First, Placebo Second|4-AP 10 mg administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching 4-AP administered 3 hours before normal sleep time on second study night.
11262985|NCT02656160|FG001|Participant Flow|Placebo First, 4-AP Second|Placebo-matching 4-AP administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then 4-AP administered 3 hours before normal sleep time on second study night.
11262986|NCT02656160|OG000|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
11262987|NCT02656160|OG001|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
11262988|NCT02656160|EG000|Reported Event|Placebo|Placebo: Placebo 3 hrs before sleep
11262989|NCT02656160|EG001|Reported Event|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
11262990|NCT02656173|BG000|Baseline|Placebo|Participants received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
11262991|NCT02656173|BG001|Baseline|Mirabegron 50mg|Participants received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks.
11262992|NCT02656173|BG002|Baseline|Total|Total of all reporting groups
11262993|NCT02656173|FG000|Participant Flow|Placebo|Participants received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
11262994|NCT02656173|FG001|Participant Flow|Mirabegron 50mg|Participants received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks.
11262995|NCT02656173|OG000|Outcome|Placebo|Participants received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
11262996|NCT02656173|OG001|Outcome|Mirabegron 50mg|Participants received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks.
11262997|NCT02656173|OG000|Outcome|Placebo|Patients received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
11262998|NCT02656173|OG001|Outcome|Mirabegron 50mg|Patients received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks.
11262999|NCT02656173|EG000|Reported Event|Placebo|Participants received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
11263000|NCT02656173|EG001|Reported Event|Mirabegron 50mg|Participants received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks.
11263001|NCT02656329|BG000|Baseline|AdreView™|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) <1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M >= 1.6 continued to receive GDMT according to clinical standard practice.
11263002|NCT02656329|BG001|Baseline|Standard of Care|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
11263003|NCT02656329|BG002|Baseline|Total|Total of all reporting groups
11263004|NCT02656329|FG000|Participant Flow|AdreView™|Participants received 1 intravenous injection of 10 millicurie (mCi) (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) <1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M >= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice.
11263005|NCT02656329|FG001|Participant Flow|Standard of Care|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted Heart Failure (HF) guidelines.
11263006|NCT02656329|OG000|Outcome|AdreView™|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio <1.6 underwent ICD device implantation and H/M ratio >= 1.6 continued to receive GDMT according to clinical standard practice.
11263007|NCT02656329|OG001|Outcome|Standard of Care|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
11263008|NCT02656329|EG000|Reported Event|AdreView™|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio <1.6 underwent ICD device implantation and H/M ratio >= 1.6 continued to receive GDMT according to clinical standard practice.
11263009|NCT02656329|EG001|Reported Event|Standard of Care|Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
11263010|NCT02656329|EG002|Reported Event|Total Participants|All participants who were randomized in AdreView™ and Standard of Care group in addition with non-randomized participants who signed informed consent form.
11263011|NCT02656420|BG000|Baseline|Placebo|"Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263012|NCT02656420|BG001|Baseline|High Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263013|NCT02656420|BG002|Baseline|Medium Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263014|NCT02656420|BG003|Baseline|Low Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263015|NCT02656420|BG004|Baseline|Total|Total of all reporting groups
11263016|NCT02656420|FG000|Participant Flow|Placebo|"Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263017|NCT02656420|FG001|Participant Flow|High Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263018|NCT02656420|FG002|Participant Flow|Medium Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263019|NCT02656420|FG003|Participant Flow|Low Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263020|NCT02656420|OG000|Outcome|Placebo|"Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263021|NCT02656420|OG001|Outcome|High Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263022|NCT02656420|OG002|Outcome|Medium Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263023|NCT02656420|OG003|Outcome|Low Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263024|NCT02656420|OG001|Outcome|Low Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263025|NCT02656420|OG003|Outcome|High Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263026|NCT02656420|EG000|Reported Event|Placebo|"Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263027|NCT02656420|EG001|Reported Event|High Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263028|NCT02656420|EG002|Reported Event|Medium Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263029|NCT02656420|EG003|Reported Event|Low Dose Broccoli Sprout|"Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.~Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo."
11263030|NCT02656485|BG000|Baseline|Dose I|"B244 dose strength I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263031|NCT02656485|BG001|Baseline|Dose II|"B244 dose strength II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263032|NCT02656485|BG002|Baseline|Dose III|"B244 dose strength III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263033|NCT02656485|BG003|Baseline|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263034|NCT02656485|BG004|Baseline|Total|Total of all reporting groups
11263035|NCT02656485|FG000|Participant Flow|Dose I|BB244 Dose I : 10 pumps of spray applied BID twice a day to the entire face for 14 days
10820353|NCT00057551|FG002|Participant Flow|Medication Only|"An algorithm including Sertraline, Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
11263036|NCT02656485|FG001|Participant Flow|Dose II|BB244 Dose II : 10 pumps of spray applied BID twice a day to the entire face for 14 days
11263037|NCT02656485|FG002|Participant Flow|Dose III|BB244 Dose III: 10 pumps of spray applied BID twice a day to the entire face for 14 days
11263038|NCT02656485|FG003|Participant Flow|Placebo|Placebo: 10 pumps of spray applied BID twice a day to the entire face for 14 days
11263039|NCT02656485|OG000|Outcome|Dose I|"B244 dose I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263040|NCT02656485|OG001|Outcome|Dose II|"B244 dose II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263041|NCT02656485|OG002|Outcome|Dose III|"B244 dose III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263042|NCT02656485|OG003|Outcome|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263043|NCT02656485|OG000|Outcome|Pooled Active Doses|Pooled Active Doses (Doses I, II, III)
11263044|NCT02656485|OG001|Outcome|Placebo|Placebo Arm
11263045|NCT02656485|EG000|Reported Event|Dose I|"B244 Dose 1 (dose level [cells/mL] 20,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263046|NCT02656485|EG001|Reported Event|Dose II|"B244 Dose 2 (dose level [cells/mL] 40,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263047|NCT02656485|EG002|Reported Event|Dose III|"B244 Dose 3 (dose level [cells/mL] 80,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11263048|NCT02656485|EG003|Reported Event|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
11286725|NCT02891915|BG000|Baseline|Short Course|"Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.~Placebo: Placebo"
11263049|NCT02656680|BG000|Baseline|FB+Friends|"FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8.~FB + Friends: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8."
11263050|NCT02656680|BG001|Baseline|FB Only|"FB Only Facebook-delivered weight loss intervention including only study participants.~FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet."
11263051|NCT02656680|BG002|Baseline|Total|Total of all reporting groups
11263052|NCT02656680|FG000|Participant Flow|FB+Friends|"FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.~Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8."
11263053|NCT02656680|FG001|Participant Flow|FB Only|"FB Only Facebook-delivered weight loss intervention including only study participants.~FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet."
11263054|NCT02656680|OG000|Outcome|FB+Friends|FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.
11263055|NCT02656680|OG001|Outcome|FB Only|FB Only Facebook-delivered weight loss intervention including only study participants.
11263056|NCT02656680|OG000|Outcome|FB+Friends|FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8.
11263057|NCT02656680|OG001|Outcome|FB Only|FB Only is a Facebook-delivered weight loss intervention including only study participants.
11263058|NCT02656680|EG000|Reported Event|FB+Friends|"FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8.~Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8."
11263059|NCT02656680|EG001|Reported Event|FB Only|"FB Only Facebook-delivered weight loss intervention including only study participants.~FB Only: Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet."
11263060|NCT02656693|BG000|Baseline|Usual Care|Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)
11263061|NCT02656693|BG001|Baseline|Online Program Only|"Patients will use an online weight management program called BMIQ, with minimal additional support.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program."
10820354|NCT00057551|OG000|Outcome|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
10820355|NCT00057551|OG001|Outcome|Brief SP|Supportive Therapy
10820356|NCT00057551|OG002|Outcome|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
11263062|NCT02656693|BG002|Baseline|Combined Intervention|"Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.~Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol."
11263063|NCT02656693|BG003|Baseline|Total|Total of all reporting groups
11263064|NCT02656693|FG000|Participant Flow|Usual Care|Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)
11263065|NCT02656693|FG001|Participant Flow|Online Program Only|"Patients will use an online weight management program called BMIQ, with minimal additional support.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program."
11263066|NCT02656693|FG002|Participant Flow|Combined Intervention|"Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.~Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol."
11263067|NCT02656693|OG000|Outcome|Usual Care|Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)
11263068|NCT02656693|OG001|Outcome|Online Program Only|"Patients will use an online weight management program called BMIQ, with minimal additional support.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program."
11263069|NCT02656693|OG002|Outcome|Combined Intervention|"Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.~Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol."
11263070|NCT02656693|EG000|Reported Event|Usual Care|Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)
11263071|NCT02656693|EG001|Reported Event|Online Program Only|"Patients will use an online weight management program called BMIQ, with minimal additional support.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program."
11263072|NCT02656693|EG002|Reported Event|Combined Intervention|"Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.~Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.~Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol."
11263073|NCT02656745|BG000|Baseline|Mobile Smoking Cessation Solution|"Subjects download & use the mobile application.~Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete missions, daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly Check-Ins are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program."
11337456|NCT03585712|OG000|Outcome|Delayed Pill Intake|"All the subjects of Arm A during treatment period 2 and all the subjects of Arm B during treatment period 3~Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they delayed their pill intake of 6 hours"
11263074|NCT02656745|FG000|Participant Flow|Mobile Smoking Cessation Solution|"Subjects download & use the mobile application.~Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete missions, daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly Check-Ins are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program."
11263075|NCT02656745|OG000|Outcome|Mobile Smoking Cessation Solution|"Subjects download & use the mobile application.~Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete missions, daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly Check-Ins are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program."
11263076|NCT02656745|OG000|Outcome|Adverse Events|Total Adverse Events
11263077|NCT02656745|OG000|Outcome|ITT Sample Population|"Subjects download & use the mobile application.~Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete missions, daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly Check-Ins are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program."
11263078|NCT02656745|OG001|Outcome|Completers|ITT sample- completed the outcome survey
11263079|NCT02656745|EG000|Reported Event|Adverse Events|Total Adverse Events
11263080|NCT02656836|BG000|Baseline|Home Tonometry Group|No comparator
11263081|NCT02656836|FG000|Participant Flow|Home Tonometry Group|No comparator
11263082|NCT02656836|OG000|Outcome|Home Tonometry Group|
11263083|NCT02656836|EG000|Reported Event|Home Tonometry Group|
11263084|NCT02656875|BG000|Baseline|TRV130|"For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.~For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.~TRV130"
11263085|NCT02656875|FG000|Participant Flow|TRV130|"For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.~For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval."
11263086|NCT02656875|OG000|Outcome|TRV130|"For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.~For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval."
11263087|NCT02656875|EG000|Reported Event|TRV130|"For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.~For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval."
11263088|NCT02657031|BG000|Baseline|Control Arm|"This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus~Prochlorperazine: prochlorperazine 10 mg IV~Diphenhydromine: Diphenhydromine 25 mg IV~Normal Saline: Normal Saline 500 cc IV Bolus"
11263089|NCT02657031|BG001|Baseline|Study Arm|"This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Sailing 500 cc bolus.~Ketamine: Ketamine 0.3 mg/kg IV~Ondansetron: Ondansetron 4 mg IV~Normal Saline: Normal Saline 500 cc IV Bolus"
11263090|NCT02657031|BG002|Baseline|Total|Total of all reporting groups
11263091|NCT02657031|FG000|Participant Flow|Control Arm|Prochlorperazine and Diphenhydramine
11263092|NCT02657031|FG001|Participant Flow|Study Arm|Ketamine and Ondansetron
11263093|NCT02657031|OG000|Outcome|Control Arm|Prochlorperazine and Diphenhydramine
11263094|NCT02657031|OG001|Outcome|Study Arm|Ketamine and Ondansetron
11263095|NCT02657031|EG000|Reported Event|Control Arm|Prochlorperazine and Diphenhydramine
11263096|NCT02657031|EG001|Reported Event|Study Arm|Ketamine and Ondansetron
11263097|NCT02657226|BG000|Baseline|Study Population Undergoing Urine Output and Serum Creatinine|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
10820357|NCT00057551|EG000|Reported Event|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
10820358|NCT00057551|EG001|Reported Event|BriefSP|Supportive Therapy
11263098|NCT02657226|FG000|Participant Flow|Study Population Undergoing Urine Output and Serum Creatinine|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
11263099|NCT02657226|OG000|Outcome|Intensive vs Non-Intensive UO Monitoring|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
11263100|NCT02657226|OG001|Outcome|Intensive vs Non-Intensive SC Monitoring|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
11263101|NCT02657226|OG000|Outcome|Study Population Undergoing Urine Output and Serum Creatinine|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission
11263102|NCT02657226|OG000|Outcome|Study Population Undergoing Urine Output and Serum Creatinine|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
11263103|NCT02657226|EG000|Reported Event|Study Population Undergoing Urine Output and Serum Creatinine|We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of > 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
11263104|NCT02657252|BG000|Baseline|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263105|NCT02657252|BG001|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263106|NCT02657252|BG002|Baseline|Total|Total of all reporting groups
11263107|NCT02657252|FG000|Participant Flow|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263108|NCT02657252|FG001|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263109|NCT02657252|OG000|Outcome|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
10820359|NCT00057551|EG002|Reported Event|Medication|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
11263110|NCT02657252|OG001|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263111|NCT02657252|EG000|Reported Event|Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263112|NCT02657252|EG001|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects~Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb."
11263113|NCT02657369|BG000|Baseline|Lenvatinib 24 mg|Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
11263114|NCT02657369|FG000|Participant Flow|Lenvatinib 24 mg|Participants received lenvatinib 24 milligram (mg) (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
11263115|NCT02657369|OG000|Outcome|Lenvatinib 24 mg|Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
11263116|NCT02657369|EG000|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).
11263117|NCT02657408|BG000|Baseline|Placebo|Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263118|NCT02657408|BG001|Baseline|BI 1026706|Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263119|NCT02657408|BG002|Baseline|Total|Total of all reporting groups
11263120|NCT02657408|FG000|Participant Flow|Placebo|Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263121|NCT02657408|FG001|Participant Flow|BI 1026706|Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263122|NCT02657408|OG000|Outcome|Placebo|Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263123|NCT02657408|OG001|Outcome|BI 1026706|Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263124|NCT02657408|EG000|Reported Event|Placebo|Subjects were orally treated with matching placebo as film-coated tablets twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263125|NCT02657408|EG001|Reported Event|BI 1026706|Subjects were orally treated with BI 1026706 as film-coated tablets 100 mg twice daily in the morning and evening from beginning on Day 1 (Visit 2) until Day 28.
11263126|NCT02657538|BG000|Baseline|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11263127|NCT02657538|FG000|Participant Flow|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11263128|NCT02657538|OG000|Outcome|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
11263129|NCT02657538|OG001|Outcome|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
11263130|NCT02657538|OG000|Outcome|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
11263131|NCT02657538|EG000|Reported Event|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
11263132|NCT02657538|EG001|Reported Event|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
11263133|NCT02657564|BG000|Baseline|Polyethylene Glycol (PEG)|"3L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.~3L Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol."
11263134|NCT02657564|FG000|Participant Flow|Polyethylene Glycol (PEG)|"3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.~Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol."
11263135|NCT02657564|OG000|Outcome|Polyethylene Glycol (PEG)|A total of 1,163 patients completed the study protocol in which 3-L polyethylene glycol was used as colonoscopy preparation.
11263136|NCT02657564|OG000|Outcome|Polyethylene Glycol (PEG)|"3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.~Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol."
11263137|NCT02657564|EG000|Reported Event|Polyethylene Glycol (PEG)|"3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.~Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol."
11263138|NCT02657629|BG000|Baseline|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263139|NCT02657629|BG001|Baseline|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263140|NCT02657629|BG002|Baseline|Total|Total of all reporting groups
11263141|NCT02657629|FG000|Participant Flow|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263142|NCT02657629|FG001|Participant Flow|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263143|NCT02657629|OG000|Outcome|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263144|NCT02657629|OG001|Outcome|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263145|NCT02657629|EG000|Reported Event|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263146|NCT02657629|EG001|Reported Event|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
11263147|NCT02657889|BG000|Baseline|Phase 1: Niraparib 200mg + Pembrolizumab|Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263148|NCT02657889|BG001|Baseline|Phase 1: Niraparib 300mg + Pembrolizumab|Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263149|NCT02657889|BG002|Baseline|Phase 2 OC: Niraparib 200mg + Pembrolizumab|Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263150|NCT02657889|BG003|Baseline|Phase 2 TNBC: Niraparib 200mg + Pembrolizumab|Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263151|NCT02657889|BG004|Baseline|Total|Total of all reporting groups
11263152|NCT02657889|FG000|Participant Flow|Phase 1: Niraparib 200mg + Pembrolizumab|Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263153|NCT02657889|FG001|Participant Flow|Phase 1: Niraparib 300mg + Pembrolizumab|Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263154|NCT02657889|FG002|Participant Flow|Phase 2 OC: Niraparib 200mg + Pembrolizumab|Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263155|NCT02657889|FG003|Participant Flow|Phase 2 TNBC: Niraparib 200mg + Pembrolizumab|Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263156|NCT02657889|OG000|Outcome|Phase 1: Niraparib 200mg + Pembrolizumab|Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263157|NCT02657889|OG001|Outcome|Phase 1: Niraparib 300mg + Pembrolizumab|Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263158|NCT02657889|OG000|Outcome|Phase 2 OC: Niraparib 200mg + Pembrolizumab|Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263159|NCT02657889|OG001|Outcome|Phase 2 TNBC: Niraparib 200mg + Pembrolizumab|Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263160|NCT02657889|OG002|Outcome|Phase 2 OC: Niraparib 200mg + Pembrolizumab|Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263161|NCT02657889|OG003|Outcome|Phase 2 TNBC: Niraparib 200mg + Pembrolizumab|Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263162|NCT02657889|EG000|Reported Event|Phase 1: Niraparib 200mg + Pembrolizumab|Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263163|NCT02657889|EG001|Reported Event|Phase 1: Niraparib 300mg + Pembrolizumab|Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263164|NCT02657889|EG002|Reported Event|Phase 2 OC: Niraparib 200mg + Pembrolizumab|Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263165|NCT02657889|EG003|Reported Event|Phase 2 TNBC: Niraparib 200mg + Pembrolizumab|Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
11263166|NCT02657915|BG000|Baseline|Placebo|This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161).
11263167|NCT02657915|BG001|Baseline|BIIB033 (Opicinumab) 100 mg/kg|This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161).
11263168|NCT02657915|BG002|Baseline|Total|Total of all reporting groups
11263169|NCT02657915|FG000|Participant Flow|Placebo|This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161).
11263170|NCT02657915|FG001|Participant Flow|BIIB033 (Opicinumab) 100 mg/kg|This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161).
11263171|NCT02657915|OG000|Outcome|Placebo|This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161).
11263172|NCT02657915|OG001|Outcome|BIIB033 (Opicinumab) 100 mg/kg|This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161).
11263173|NCT02657915|EG000|Reported Event|Placebo|This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161).
11263174|NCT02657915|EG001|Reported Event|BIIB033 (Opicinumab) 100 mg/kg|This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161).
11263175|NCT02657928|BG000|Baseline|Cohort A: Ovarian|Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263176|NCT02657928|BG001|Baseline|Cohort B: Endometrial|Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263177|NCT02657928|BG002|Baseline|Total|Total of all reporting groups
11263178|NCT02657928|FG000|Participant Flow|Cohort A: Ovarian|Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263179|NCT02657928|FG001|Participant Flow|Cohort B: Endometrial|Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263180|NCT02657928|OG000|Outcome|Cohort A: Ovarian|Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263181|NCT02657928|OG001|Outcome|Cohort B: Endometrial|Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263182|NCT02657928|OG000|Outcome|Overall (Cohort A + Cohort B)|Patients with either ovarian, primary peritoneal, fallopian tube ACA or endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263183|NCT02657928|EG000|Reported Event|Cohort A: Ovarian|Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263184|NCT02657928|EG001|Reported Event|Cohort B: Endometrial|Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
11263185|NCT02658019|BG000|Baseline|Pembrolizumab in Advanced HCC|Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
11263186|NCT02658019|FG000|Participant Flow|Pembrolizumab in Advanced HCC|Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
11263187|NCT02658019|OG000|Outcome|Pembrolizumab in Advanced HCC|Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
11263188|NCT02658019|EG000|Reported Event|Pembrolizumab in Advanced HCC|Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
11263189|NCT02658084|BG000|Baseline|Phase 1: T-DM1 + Vinorelbine|"One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D).~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263190|NCT02658084|BG001|Baseline|Phase 2: T-DM1 + RP2D Vinorelbine|"One cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I.~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263191|NCT02658084|BG002|Baseline|Total|Total of all reporting groups
11263192|NCT02658084|FG000|Participant Flow|Phase 1: T-DM1 + Vinorelbine|"One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D).~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263193|NCT02658084|FG001|Participant Flow|Phase 2: T-DM1 + RP2D Vinorelbine|"One cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I.~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263194|NCT02658084|OG000|Outcome|Phase 1: T-DM1 + Vinorelbine|"One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D).~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263195|NCT02658084|OG000|Outcome|Phase 2: T-DM1 + RP2D Vinorelbine|"One cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I.~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263196|NCT02658084|EG000|Reported Event|Phase 1: T-DM1 + Vinorelbine|"One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D).~Vinorelbine: Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.~Trastuzumab Emtansine: Administered as an intravenous infusion on Day 1 of every 21-day cycle."
11263197|NCT02658149|BG000|Baseline|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11263198|NCT02658149|BG001|Baseline|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11263199|NCT02658149|BG002|Baseline|Total|Total of all reporting groups
11263200|NCT02658149|FG000|Participant Flow|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11263201|NCT02658149|FG001|Participant Flow|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11263202|NCT02658149|OG000|Outcome|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11263203|NCT02658149|OG001|Outcome|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11263204|NCT02658149|EG000|Reported Event|Psoas Compartment Block|"After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).~Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment"
11263205|NCT02658149|EG001|Reported Event|Periarticular Local Anesthetic|"An anesthetic cocktail of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.~Epinephrine: 0.15 mg Epinephrine are injected as part of the drug cocktail~Morphine: 4 mg Morphine are injected as part of the drug cocktail~Ketorolac Tromethamine: 30 mg morphine are injected as part of the drug cocktail~Ropivacaine: 30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
11263206|NCT02658175|BG000|Baseline|Treatment-naïve Group|Treatment naïve group included combined group of ISIS 304801-CS7 (CS7-New) study participant and participant on placebo in index studies (ISIS 304801-CS6- Placebo [NCT02211209] and ISIS 304801-CS16-Placebo [NCT02300233]), were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263207|NCT02658175|BG001|Baseline|CS6-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS6 (NCT02211209) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263208|NCT02658175|BG002|Baseline|CS16-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS16 (NCT02300233) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263209|NCT02658175|BG003|Baseline|Total|Total of all reporting groups
11263210|NCT02658175|FG000|Participant Flow|Treatment-naïve Group|Treatment naïve group included combined group of ISIS 304801-CS7 (CS7-New) study participant and participant on placebo in index studies (ISIS 304801-CS6- Placebo [NCT02211209] and ISIS 304801-CS16-Placebo [NCT02300233]), were to receive 300 milligrams (mg) of volanesorsen as a single subcutaneous (SC) injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263211|NCT02658175|FG001|Participant Flow|CS6-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS6 (NCT02211209) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263212|NCT02658175|FG002|Participant Flow|CS16-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS16 (NCT02300233) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263213|NCT02658175|OG000|Outcome|Treatment-naïve Group|Treatment naïve group included combined group of ISIS 304801-CS7 (CS7-New) study participant and participant on placebo in index studies (ISIS 304801-CS6- Placebo [NCT02211209] and ISIS 304801-CS16-Placebo [NCT02300233]), were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263214|NCT02658175|OG001|Outcome|CS6-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS6 (NCT02211209) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263215|NCT02658175|OG002|Outcome|CS16-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS16 (NCT02300233) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263216|NCT02658175|EG000|Reported Event|Treatment-naïve Group|Treatment naïve group included combined group of ISIS 304801-CS7 (CS7-New) study participant and participant on placebo in index studies (ISIS 304801-CS6- Placebo [NCT02211209] and ISIS 304801-CS16-Placebo [NCT02300233]), were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263217|NCT02658175|EG001|Reported Event|CS6-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS6 (NCT02211209) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263218|NCT02658175|EG002|Reported Event|CS16-Volanesorsen|Participants with FCS rolling over from the ISIS 304801-CS16 (NCT02300233) index study after receiving volanesorsen, were to receive 300 mg of volanesorsen as a single SC injection once weekly for Weeks 1-52 of this study. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Following the Week 52 visit, participants had the option of participating in an expanded access program or continuing treatment with 300 mg of volanesorsen as a single SC injection once-weekly for up to an additional 52 weeks (Weeks 53-104) and in France participants, up to an additional 104 weeks for total of 156 weeks of treatment (Weeks 105 to Week 156) of this study until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week post-treatment evaluation period and in France, participants not continuing treatment were to enter a 26-week post-treatment follow-up period.
11263219|NCT02658240|BG000|Baseline|Compartment Block|"Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263220|NCT02658240|BG001|Baseline|Infiltration|"Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263221|NCT02658240|BG002|Baseline|Total|Total of all reporting groups
11263222|NCT02658240|FG000|Participant Flow|Compartment Block|"Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263223|NCT02658240|FG001|Participant Flow|Infiltration|"Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263224|NCT02658240|OG000|Outcome|Compartment Block|"Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263225|NCT02658240|OG001|Outcome|Infiltration|"Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263226|NCT02658240|EG000|Reported Event|Compartment Block|"Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263227|NCT02658240|EG001|Reported Event|Infiltration|"Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision~Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL~Epinephrine: 0.5 mg epinephrine"
11263228|NCT02658448|BG000|Baseline|GTx-024 3 mg|"GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg"
11263229|NCT02658448|FG000|Participant Flow|GTx-024 3 mg|"GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg"
11263230|NCT02658448|OG000|Outcome|GTx-024 3 mg|"GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg"
11263231|NCT02658448|EG000|Reported Event|GTx-024 3 mg|"GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.~GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg"
11263232|NCT02658461|BG000|Baseline|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263233|NCT02658461|BG001|Baseline|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263234|NCT02658461|BG002|Baseline|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263235|NCT02658461|BG003|Baseline|Total|Total of all reporting groups
11263236|NCT02658461|FG000|Participant Flow|Trastuzumab Single-Use Injection Device|Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263237|NCT02658461|FG001|Participant Flow|Trastuzumab Subcutaneous (SC) Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263238|NCT02658461|FG002|Participant Flow|Trastuzumab Intravenous (IV) Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263239|NCT02658461|OG000|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263240|NCT02658461|OG000|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263241|NCT02658461|OG000|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263242|NCT02658461|OG001|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263243|NCT02658461|OG002|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263244|NCT02658461|EG000|Reported Event|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263245|NCT02658461|EG001|Reported Event|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263246|NCT02658461|EG002|Reported Event|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
11263247|NCT02658487|BG000|Baseline|Treatment (Vosaroxin, Cytarabine)|"Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I). Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I.~Cytarabine: Given IV~Vosaroxin: Given IV"
11263248|NCT02658487|FG000|Participant Flow|Treatment (Vosaroxin, Cytarabine) Induction|"Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I). Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I.~Cytarabine: Given IV~Vosaroxin: Given IV"
11263249|NCT02658487|OG000|Outcome|Treatment (Vosaroxin, Cytarabine)|"Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I). Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I.~Cytarabine: Given IV~Vosaroxin: Given IV"
11263250|NCT02658487|EG000|Reported Event|Treatment (Vosaroxin, Cytarabine) Induction 1|"Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I).~Cytarabine: Given IV~Vosaroxin: Given IV"
11263251|NCT02658487|EG001|Reported Event|Induction 2|Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I.
11263252|NCT02658630|BG000|Baseline|Device: Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
11263253|NCT02658630|FG000|Participant Flow|Device: Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
11263254|NCT02658630|OG000|Outcome|Device: Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
11263255|NCT02658630|EG000|Reported Event|Device: Robot + TTT Exercise|"All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.~Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session."
11263256|NCT02658734|BG000|Baseline|Trastuzumab Emtansine|3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
11263257|NCT02658734|FG000|Participant Flow|Trastuzumab Emtansine|3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
11263258|NCT02658734|OG000|Outcome|Trastuzumab Emtansine|3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
11263259|NCT02658734|EG000|Reported Event|Trastuzumab Emtansine|3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
11263260|NCT02658851|BG000|Baseline|J-Plasma|"Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.~J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."
11263261|NCT02658851|FG000|Participant Flow|J-Plasma|"Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.~J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."
11263262|NCT02658851|OG000|Outcome|J-Plasma|"Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.~J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."
11263263|NCT02658851|EG000|Reported Event|J-Plasma|"Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.~J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."
11263264|NCT02658994|BG000|Baseline|Enhanced Usual Care|Informing participants and LHWs about depression status and ways to seek help.
11263265|NCT02658994|BG001|Baseline|THPP and THPP+|Group based booster sessions which included peer support behavioral activation and problem solving.
11263266|NCT02658994|BG002|Baseline|No Prenatal Depression|No prenatal depression at baseline.
11263267|NCT02658994|BG003|Baseline|Total|Total of all reporting groups
11263268|NCT02658994|FG000|Participant Flow|Enhanced Usual Care|Women in the control clusters who were depressed prenatally have been receiving Enhanced Usual Care (EUC). At the time of the screening, women, their Lady Health Workers, and their local primary health care facility were informed of the diagnosis, and women were given an information sheet about depression and how to access care. There are no new EUC protocols put in place post-partum as part of the THPP+.
11263269|NCT02658994|FG001|Participant Flow|THPP+|"As part of THPP+, the intervention will continue from the 6th month postnatal through 36 months postnatal and so will consist of an additional 30 months of lower intensity services that are unique to THPP+. The THPP+ will also include additional group sessions to be held every other month for a total of 18 over the intervention duration. The content will be a continuation of the previous THPP sessions with continuing emphasis on self-care as well as the baby's health and development.~Thinking Healthy Program Peer Delivered Plus"
11263270|NCT02658994|FG002|Participant Flow|No Prenatal Depression|No prenatal depression recorded at baseline.
11263271|NCT02658994|OG000|Outcome|Enhanced Usual Care|Informing participants and LHWs about depression status and ways to seek help.
11263272|NCT02658994|OG001|Outcome|THPP and THPP+|Group based booster sessions which included peer support behavioral activation and problem solving.
11263273|NCT02658994|OG002|Outcome|No Prenatal Depression|No prenatal depression at baseline.
11263274|NCT02658994|OG002|Outcome|No Prenatal Depression|No prenatal depression at baseline
11263275|NCT02658994|EG000|Reported Event|Enhanced Usual Care|Informing participants and LHWs about depression status and ways to seek help.
11263276|NCT02658994|EG001|Reported Event|THPP and THPP+|Group based booster sessions which included peer support behavioral activation and problem solving.
11263277|NCT02658994|EG002|Reported Event|No Prenatal Depression|No prenatal depression at baseline.
11263278|NCT02659098|BG000|Baseline|CNTO 2476 3.0*10^5 Cells|Participants received a single subretinal administration of CNTO 2476 (Palucorcel) comprising 3.0*10^5 cells in 50 microliters (mcL) dosing volume on Day 1. CNTO 2476 was delivered using the custom-designed Delivery System and surgical procedure.
11263279|NCT02659098|FG000|Participant Flow|CNTO 2476 3.0*10^5 Cells|Participants received a single subretinal administration of CNTO 2476 (Palucorcel) comprising 3.0*10^5 cells in 50 microliters (mcL) dosing volume on Day 1. CNTO 2476 was delivered using the custom-designed Delivery System and surgical procedure.
11263280|NCT02659098|OG000|Outcome|CNTO 2476 3.0*10^5 Cells|Participants received a single subretinal administration of CNTO 2476 (Palucorcel) comprising 3.0*10^5 cells in 50 microliters (mcL) dosing volume on Day 1. CNTO 2476 was delivered using the custom-designed Delivery System and surgical procedure.
11263281|NCT02659098|EG000|Reported Event|CNTO 2476 3.0*10^5 Cells|Participants received a single subretinal administration of CNTO 2476 (Palucorcel) comprising 3.0*10^5 cells in 50 microliters (mcL) dosing volume on Day 1. CNTO 2476 was delivered using the custom-designed Delivery System and surgical procedure.
11263282|NCT02659150|BG000|Baseline|Open-Label Tocilizumab|"tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week~tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU)."
11263283|NCT02659150|FG000|Participant Flow|Open-Label Tocilizumab|"tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week~tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU)."
11263284|NCT02659150|OG000|Outcome|Open-Label Tocilizumab|"tocilizumab was given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week~tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU)."
11263285|NCT02659150|OG000|Outcome|Open-Label Tocilizumab|"tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week~tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU)."
11263286|NCT02659150|EG000|Reported Event|Open-Label Tocilizumab|"tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week~tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU)."
11263287|NCT02659501|BG000|Baseline|Bupivacaine With Epinephrine Injections|"Patients in the control arm will be treated intra-operatively with standard of care, 0.25% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.~Bupivacaine with epinephrine: Bupivacaine is a local anesthetic. This drug is the current standard of care for local anesthesia following breast reconstruction.~Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.~Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.~Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms."
11263288|NCT02659501|BG001|Baseline|Liposomal Bupivacaine|"Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.~Liposomal bupivacaine: Liposomal Bupivacaine is a suspension of multivesicular liposomes containing bupivacaine. After injection, bupivacaine is slowly released from the liposomes, extending this drug's duration of action.~Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.~Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.~Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms."
11263289|NCT02659501|BG002|Baseline|Total|Total of all reporting groups
11263290|NCT02659501|FG000|Participant Flow|Bupivacaine With Epinephrine Injections|"Patients in the control arm will be treated intra-operatively with standard of care, 0.25% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.~Bupivacaine with epinephrine: Bupivacaine is a local anesthetic. This drug is the current standard of care for local anesthesia following breast reconstruction.~Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.~Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.~Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms."
11263291|NCT02659501|FG001|Participant Flow|Liposomal Bupivacaine|"Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.~Liposomal bupivacaine: Liposomal Bupivacaine is a suspension of multivesicular liposomes containing bupivacaine. After injection, bupivacaine is slowly released from the liposomes, extending this drug's duration of action.~Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.~Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.~Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms."
11263292|NCT02659501|OG000|Outcome|Bupivacaine With Epinephrine Injections|Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
11263293|NCT02659501|OG001|Outcome|Liposomal Bupivacaine|Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
11263294|NCT02659501|EG000|Reported Event|Bupivacaine With Epinephrine Injections|Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
11263295|NCT02659501|EG001|Reported Event|Liposomal Bupivacaine|Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
11263296|NCT02659540|BG000|Baseline|Cohort A (Conventional RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
11263297|NCT02659540|BG001|Baseline|Cohort B (Hypofractionated RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
11263298|NCT02659540|BG002|Baseline|Total|Total of all reporting groups
11263299|NCT02659540|FG000|Participant Flow|Cohort A (Conventional RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
11263300|NCT02659540|FG001|Participant Flow|Cohort B (Hypofractionated RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
11263301|NCT02659540|OG000|Outcome|Cohort A (Conventional RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
11263302|NCT02659540|OG001|Outcome|Cohort B (Hypofractionated RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
11263303|NCT02659540|EG000|Reported Event|Cohort A (Conventional RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
11263304|NCT02659540|EG001|Reported Event|Cohort B (Hypofractionated RT)|Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
11263305|NCT02659631|BG000|Baseline|PF-06671008 1.5 ng/kg IV|PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263306|NCT02659631|BG001|Baseline|PF-06671008 7.5 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
11263307|NCT02659631|BG002|Baseline|PF-06671008 20 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263308|NCT02659631|BG003|Baseline|PF-06671008 50 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263309|NCT02659631|BG004|Baseline|PF-06671008 100 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263310|NCT02659631|BG005|Baseline|PF-06671008 200 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
11263311|NCT02659631|BG006|Baseline|PF-06671008 300 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263312|NCT02659631|BG007|Baseline|PF-06671008 400 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263313|NCT02659631|BG008|Baseline|PF-06671008 200 ng/kg SC|PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
11263314|NCT02659631|BG009|Baseline|PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
11263315|NCT02659631|BG010|Baseline|Total|Total of all reporting groups
11263316|NCT02659631|FG000|Participant Flow|PF-06671008 1.5 ng/kg IV|PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort.
11263317|NCT02659631|FG001|Participant Flow|PF-06671008 7.5 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
11263318|NCT02659631|FG002|Participant Flow|PF-06671008 20 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263319|NCT02659631|FG003|Participant Flow|PF-06671008 50 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263320|NCT02659631|FG004|Participant Flow|PF-06671008 100 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263321|NCT02659631|FG005|Participant Flow|PF-06671008 200 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
11263322|NCT02659631|FG006|Participant Flow|PF-06671008 300 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263323|NCT02659631|FG007|Participant Flow|PF-06671008 400 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263324|NCT02659631|FG008|Participant Flow|PF-06671008 200 ng/kg SC|PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
11263325|NCT02659631|FG009|Participant Flow|PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
11263326|NCT02659631|OG000|Outcome|PF-06671008 1.5 ng/kg IV|PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263327|NCT02659631|OG001|Outcome|PF-06671008 7.5 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
11263328|NCT02659631|OG002|Outcome|PF-06671008 20 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263329|NCT02659631|OG003|Outcome|PF-06671008 50 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263330|NCT02659631|OG004|Outcome|PF-06671008 100 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263331|NCT02659631|OG005|Outcome|PF-06671008 200 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
11263332|NCT02659631|OG006|Outcome|PF-06671008 300 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263333|NCT02659631|OG007|Outcome|PF-06671008 400 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263334|NCT02659631|OG008|Outcome|PF-06671008 200 ng/kg SC|PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
11263335|NCT02659631|OG009|Outcome|PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
11263336|NCT02659631|OG008|Outcome|PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
11263337|NCT02659631|OG000|Outcome|PF-06671008 200 ng/kg SC|PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
11263338|NCT02659631|EG000|Reported Event|PF-06671008 1.5 ng/kg IV|PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263339|NCT02659631|EG001|Reported Event|PF-06671008 7.5 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
11263340|NCT02659631|EG002|Reported Event|PF-06671008 20 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263341|NCT02659631|EG003|Reported Event|PF-06671008 50 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263342|NCT02659631|EG004|Reported Event|PF-06671008 100 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263343|NCT02659631|EG005|Reported Event|PF-06671008 200 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
11263344|NCT02659631|EG006|Reported Event|PF-06671008 300 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
11263345|NCT02659631|EG007|Reported Event|PF-06671008 400 ng/kg IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
11263346|NCT02659631|EG008|Reported Event|PF-06671008 200 ng/kg SC|PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
11263347|NCT02659631|EG009|Reported Event|PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV|PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
11337457|NCT03585712|OG001|Outcome|Missed Pill Intake|"All the subjects of Arm B during treatment period 2 and all the subjects of Arm A during treatment period 3~Norgestrel 0.075 mg: Subjects took norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for one specific day (Day 42 +/3 days) during treatment period 2 or treatment period 3 (Day 70 +/3 days) where they missed their pill"
11263348|NCT02659709|BG000|Baseline|Glaucoma Patients and Caregivers|50 Glaucoma patients and/or caregivers will test a glaucoma application (app) on smart phones or tablets then complete a 20 item questionnaire providing demographic information, effectiveness and ease of use with the application designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications.
11263349|NCT02659709|FG000|Participant Flow|Glaucoma Patients and Caregivers|Glaucoma patients and caregivers will test a glaucoma smartphone application (app) on smart phones or tablets then complete 20 item questionnaire providing demographic information, effectiveness and ease of use with the application designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications.
11263350|NCT02659709|OG000|Outcome|Glaucoma Smartphone Application|"Glaucoma patients and/or caregivers answered a Questionnaire on availability to Smartphone or Tablet Usage and accessing social media. Questionnaire includes 20 items regarding demographic information, effectiveness of social media and compliance with glaucoma medications.~From this information, Smartphone Application will be designed to educate glaucoma patients about the disease, testing, and treatments and also include reminders for taking medications."
11263351|NCT02659709|EG000|Reported Event|Glaucoma Smartphone Application|"50 Glaucoma patients and caregivers will test a glaucoma smartphone application (app) on smart phones or tablets then complete 20 item questionnaire providing demographic information, effectiveness and ease of use with the application.~Smartphone Application: Smartphone Application designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications."
11263352|NCT02659787|BG000|Baseline|ALL Subjects|Subjects all receive placebo, 0.2 mg buprenorphine in crossover design
11263353|NCT02659787|FG000|Participant Flow|Placebo, Then Buprenorphine|Participants first received placebo during first study session. After a washout period of 3 days, participants returned to lab and they then received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2mg).
11263354|NCT02659787|FG001|Participant Flow|Buprenorphine, Then Placebo|Participants first received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2mg) during first study session. After a washout period of 3 days, participants returned to lab and they received placebo tablet.
11263355|NCT02659787|OG000|Outcome|Low Dose Buprenorphine|"Subjects all receive placebo, 0.2 mg buprenorphine in crossover design~0.2mg Buprenorphine: Sublingual buprenorphine tablets (0.2mg)"
11263356|NCT02659787|OG001|Outcome|Placebo|"Subjects all receive placebo, 0.2 mg buprenorphine in crossover design~Placebo: Placebo"
11263357|NCT02659787|EG000|Reported Event|Placebo, Then Buprenorphine|Participants first received placebo during first study session. After a washout period of 3 days, participants returned to lab and they then received 0.2 mg buprenorphine (sublingual buprenorphine tablets (0.2 mg).
11263358|NCT02659787|EG001|Reported Event|Buprenorphine, Then Placebo|Participants first received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2 mg)) during first study session. After a washout period of 3 days, participants returned to lab and they then received placebo tablet.
11263359|NCT02659943|BG000|Baseline|LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only|LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263360|NCT02659943|BG001|Baseline|LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells
11263361|NCT02659943|BG002|Baseline|LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263362|NCT02659943|BG003|Baseline|LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only|LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263363|NCT02659943|BG004|Baseline|LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263364|NCT02659943|BG005|Baseline|LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only|LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263365|NCT02659943|BG006|Baseline|Participants Enrolled But Not Treated|Participants who were enrolled but not treated.
11263366|NCT02659943|BG007|Baseline|Total|Total of all reporting groups
11263367|NCT02659943|FG000|Participant Flow|LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only|LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263368|NCT02659943|FG001|Participant Flow|LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells
11263369|NCT02659943|FG002|Participant Flow|LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263370|NCT02659943|FG003|Participant Flow|LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only|LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263371|NCT02659943|FG004|Participant Flow|LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263372|NCT02659943|FG005|Participant Flow|LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only|LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263373|NCT02659943|FG006|Participant Flow|Participants Enrolled But Not Treated|Participants who were enrolled but not treated.
11263374|NCT02659943|OG000|Outcome|All Participants|All participants who received Biological/Vaccine: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg (weight-based dosing) (up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0 Drug: Cyclophosphamide 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 Drug: Fludarabine 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
11263375|NCT02659943|OG000|Outcome|LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only|LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263376|NCT02659943|OG001|Outcome|LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells
11263377|NCT02659943|OG002|Outcome|LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263378|NCT02659943|OG003|Outcome|LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only|LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263379|NCT02659943|OG004|Outcome|LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263380|NCT02659943|OG005|Outcome|LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only|LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263381|NCT02659943|OG000|Outcome|LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only|"LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0"
11263382|NCT02659943|OG001|Outcome|LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells|"LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0~Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3"
11263383|NCT02659943|OG002|Outcome|LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|"LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0~Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3"
11263384|NCT02659943|OG003|Outcome|LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only|"LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0"
11263385|NCT02659943|OG004|Outcome|LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|"LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0~Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3~Fludarabine: 30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3"
11263386|NCT02659943|OG005|Outcome|LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only|"LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only~Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells: Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0"
11263387|NCT02659943|EG000|Reported Event|LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only|LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263388|NCT02659943|EG001|Reported Event|LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells
11263389|NCT02659943|EG002|Reported Event|LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263390|NCT02659943|EG003|Reported Event|LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only|LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263391|NCT02659943|EG004|Reported Event|LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells|LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
11263392|NCT02659943|EG005|Reported Event|LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only|LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
11263393|NCT02660112|BG000|Baseline|(+)-Epicatechin|"Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks~(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)"
11263394|NCT02660112|FG000|Participant Flow|(+)-Epicatechin|"Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks~(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)"
11337458|NCT03585712|OG000|Outcome|OS: Reported Perfect Use Period (Treatment Period 1)|Subjects in Treatment Period 1 who also had an Ovarian Status in either Treatment Period 2 or Treatment Period 3
11337459|NCT03585712|OG001|Outcome|OS: Delayed Pill Period|"Subjects with Ovarian Status, of:~Arm A in Treatment Period 2~Arm B in Treatment Period 3"
11263395|NCT02660112|OG000|Outcome|(+)-Epicatechin|"Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks~(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)"
11263396|NCT02660112|EG000|Reported Event|(+)-Epicatechin|"Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks~(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)"
11263397|NCT02660138|BG000|Baseline|Placebo|"Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263398|NCT02660138|BG001|Baseline|Dysport® 600 U|"Subjects were administered Dysport® 600 U for the first study treatment administration on Day 1 of the DBPC cycle.~All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263399|NCT02660138|BG002|Baseline|Dysport® 800 U|"Subjects were administered Dysport® 800 U for the first study treatment administration on Day 1 of the DBPC cycle.~All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263400|NCT02660138|BG003|Baseline|Total|Total of all reporting groups
11263401|NCT02660138|FG000|Participant Flow|Placebo|"Subjects were administered placebo on Day 1 of the DBPC cycle.~All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263402|NCT02660138|FG001|Participant Flow|Dysport® 600 U|"Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle.~All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263403|NCT02660138|FG002|Participant Flow|Dysport® 800 U|"Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle.~All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263404|NCT02660138|OG000|Outcome|Placebo|"Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263405|NCT02660138|OG001|Outcome|Dysport® 600 U|"Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263406|NCT02660138|OG002|Outcome|Dysport® 800 U|"Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263407|NCT02660138|OG001|Outcome|Dysport® 600 U|"Subjects were administered Dysport® 600 U for the first study treatment administration on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263408|NCT02660138|OG002|Outcome|Dysport® 800 U|"Subjects were administered Dysport® 800 U for the first study treatment administration on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263409|NCT02660138|OG002|Outcome|Dysport® 800 U|"Subjects were administered Dysport® 800 U for on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263410|NCT02660138|EG000|Reported Event|Placebo|Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263411|NCT02660138|EG001|Reported Event|Dysport® 600 U|"Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263412|NCT02660138|EG002|Reported Event|Dysport® 800 U|"Subjects were administered Dysport® 800 U for on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each.~Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required."
11263413|NCT02660229|BG000|Baseline|Oxycodone Hydrochloride|"Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride~Oxycodone Hydrochloride: Oxycodone IV injection"
11263414|NCT02660229|BG001|Baseline|Morphine Sulphate|"Brand name: BC Morphine sulfate Generic name: Morphine sulfate~Morphine Sulphate: Morphine sulphate IV injection"
11263415|NCT02660229|BG002|Baseline|Total|Total of all reporting groups
11263416|NCT02660229|FG000|Participant Flow|Oxycodone Hydrochloride|"Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride~Oxycodone Hydrochloride: Oxycodone injection. The 10mg/1ml or 20mg/2ml was injected through intravenous PCA according to patient's pain intensity"
11263417|NCT02660229|FG001|Participant Flow|Morphine Sulphate|"Brand name: BC Morphine sulfate Generic name: Morphine sulfate~Morphine Sulphate: Morphine sulphate injection. The 5mg/5ml or 30mg/2ml was injected through intravenous PCA according to patient's pain intensity."
11263418|NCT02660229|OG000|Outcome|Oxycodone Hydrochloride|"Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride~Oxycodone Hydrochloride: Oxycodone injection"
11263419|NCT02660229|OG001|Outcome|Morphine Sulphate|"Brand name: BC Morphine sulfate Generic name: Morphine sulfate~Morphine Sulphate: Morphine sulphate injection"
11263420|NCT02660229|EG000|Reported Event|Oxycodone Hydrochloride|"Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride~Oxycodone Hydrochloride: Oxycodone injection"
11263421|NCT02660229|EG001|Reported Event|Morphine Sulphate|"Brand name: BC Morphine sulfate Generic name: Morphine sulfate~Morphine Sulphate: Morphine sulphate injection"
11263422|NCT02660242|BG000|Baseline|Entire Study Population|Includes all patients who completed the crossover trial.
11263423|NCT02660242|FG000|Participant Flow|MIni-dose Glucagon Crossover Trial|Each participant will undergo four aerobic exercise sessions (in random order) of a) a Control Trial: Fasted exercise, no basal insulin reduction; b) Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate five minutes before exercise, for the duration of the exercise); c) Strategy 2: Fasted exercise, no basal adjustment + pre-exercise and mid-exercise glucose tabs (buccal route-40 grams in total); d) Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc). Each period includes 0-165 minutes in the lab and the participant continues to wear a continuous glucose monitor during the afternoon, overnight, and through noon the following day.
11263424|NCT02660242|OG000|Outcome|Control|No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
11263425|NCT02660242|OG001|Outcome|Basal Insulin Reduction|Basal insulin reduction to 50% 5 minutes before the start of exercise.
11263426|NCT02660242|OG002|Outcome|Glucose Tabs|Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
11263427|NCT02660242|OG003|Outcome|G-Pen Mini™ (Glucagon Injection)|Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
11263428|NCT02660242|OG001|Outcome|Basal Insulin Reduction|Basal insulin reduction to 50% five minutes before the start of exercise.
11263429|NCT02660242|OG002|Outcome|Glucose Tabs|Dextrose tabs orally (20 grams) five minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
11263430|NCT02660242|OG003|Outcome|G-Pen Mini™ (Glucagon Injection)|Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen).
11263431|NCT02660242|EG000|Reported Event|Control|No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
11263432|NCT02660242|EG001|Reported Event|Basal Insulin Reduction|Basal insulin reduction to 50% 5 minutes before the start of exercise.
11263433|NCT02660242|EG002|Reported Event|Glucose Tabs|Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
11263434|NCT02660242|EG003|Reported Event|G-Pen Mini™ (Glucagon Injection)|Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
11263435|NCT02660359|BG000|Baseline|Placebo|Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263436|NCT02660359|BG001|Baseline|Dysport® 600 U|Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11337460|NCT03585712|OG002|Outcome|OS: Missed Pill Period|"Subjects with Ovarian Status, of:~Arm A in Treatment Period 3~Arm B in Treatment Period 2"
11337461|NCT03585712|OG000|Outcome|CMS: Reported Perfect Use Period (Treatment Period 1)|Subjects in Treatment Period 1 who had at least 7 cervical mucus scores in either Treatment Period 2 or Treatment Period 3
11263437|NCT02660359|BG002|Baseline|Dysport® 800 U|Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263438|NCT02660359|BG003|Baseline|Total|Total of all reporting groups
11263439|NCT02660359|FG000|Participant Flow|Placebo|Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263440|NCT02660359|FG001|Participant Flow|Dysport® 600 U|Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263441|NCT02660359|FG002|Participant Flow|Dysport® 800 U|Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263442|NCT02660359|OG000|Outcome|Placebo|Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263443|NCT02660359|OG001|Outcome|Dysport® 600 U|Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263444|NCT02660359|OG002|Outcome|Dysport® 800 U|Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263445|NCT02660359|EG000|Reported Event|Placebo|Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263446|NCT02660359|EG001|Reported Event|Dysport® 600 U|Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263447|NCT02660359|EG002|Reported Event|Dysport® 800 U|Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
11263448|NCT02660489|BG000|Baseline|OC459 (CRTH2 Antagonist)|"OC459 50mg once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263449|NCT02660489|BG001|Baseline|Placebo|"Placebo tablet once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263450|NCT02660489|BG002|Baseline|Total|Total of all reporting groups
11263451|NCT02660489|FG000|Participant Flow|OC459 (CRTH2 Antagonist)|"OC459 50mg once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263452|NCT02660489|FG001|Participant Flow|Placebo|"Placebo tablet once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263453|NCT02660489|OG000|Outcome|OC459 (CRTH2 Antagonist)|"OC459 50mg once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263454|NCT02660489|OG001|Outcome|Placebo|"Placebo tablet once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263455|NCT02660489|EG000|Reported Event|OC459 (CRTH2 Antagonist)|"OC459 50mg once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263456|NCT02660489|EG001|Reported Event|Placebo|"Placebo tablet once daily for 5 weeks~Rhinovirus: Inoculation with rhinovirus serotype 16"
11263457|NCT02660580|BG000|Baseline|MSB11022 (Core Treatment Period)|Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263458|NCT02660580|BG001|Baseline|EU-Humira|Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263459|NCT02660580|BG002|Baseline|Total|Total of all reporting groups
11337462|NCT03585712|OG001|Outcome|CMS: Delayed Pill Period|"Subjects who had at least 7 cervical mucus scores in:~Arm A: Treatment Period 2~Arm B: Treatment Period 3"
11263460|NCT02660580|FG000|Participant Flow|MSB11022 (Core Treatment Period)|Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263461|NCT02660580|FG001|Participant Flow|EU-Humira|Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263462|NCT02660580|FG002|Participant Flow|MSB11022 (Extended Treatment Period)|Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263463|NCT02660580|FG003|Participant Flow|EU-Humira/EU-Humira|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
11263464|NCT02660580|FG004|Participant Flow|EU-Humira/MSB11022|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263465|NCT02660580|OG000|Outcome|MSB11022 (Core Treatment Period)|Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263466|NCT02660580|OG001|Outcome|EU-Humira|Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263467|NCT02660580|OG000|Outcome|MSB11022 (Extended Treatment Period)|Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263468|NCT02660580|OG001|Outcome|EU-Humira/EU-Humira|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
11263469|NCT02660580|OG002|Outcome|EU-Humira/MSB11022|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263470|NCT02660580|OG000|Outcome|MSB11022 (Overall Treatment Period)|Participants received MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 1 up to and including Week 50 in overall treatment period.
11263471|NCT02660580|OG001|Outcome|EU-Humira/EU-Humira (Overall Treatment Period)|Participants who received EU-Humira up to Week 16 continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in overall treatment period.
11263472|NCT02660580|OG002|Outcome|EU-Humira/MSB11022 (Overall Treatment Period)|Participants who received EU-Humira up to Week 16 were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in overall treatment period.
11263473|NCT02660580|OG001|Outcome|MSB11022 (Extended Treatment Period)|Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263474|NCT02660580|OG002|Outcome|EU-Humira|Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263475|NCT02660580|OG003|Outcome|EU-Humira/EU-Humira|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
11263476|NCT02660580|OG004|Outcome|EU-Humira/MSB11022|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263477|NCT02660580|EG000|Reported Event|MSB11022 (Core Treatment Period)|Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263478|NCT02660580|EG001|Reported Event|EU-Humira|Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
11263479|NCT02660580|EG002|Reported Event|MSB11022 (Extended Treatment Period)|Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263480|NCT02660580|EG003|Reported Event|EU-Humira/EU-Humira|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
11263481|NCT02660580|EG004|Reported Event|EU-Humira/MSB11022|Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
11263482|NCT02660788|BG000|Baseline|Control Arm|"Mail~Standard Reminder Postcard"
11263483|NCT02660788|BG001|Baseline|Family Physician Reminder Letter Arm|"Mail~Standard Reminder Postcard~Family Physician Reminder Letter"
11263484|NCT02660788|BG002|Baseline|Total|Total of all reporting groups
11263485|NCT02660788|FG000|Participant Flow|Control Arm|"Mail~Standard Reminder Postcard"
11263486|NCT02660788|FG001|Participant Flow|Family Physician Reminder Letter Arm|"Mail~Standard Reminder Postcard~Family Physician Reminder Letter"
11263487|NCT02660788|OG000|Outcome|Control Arm|"Mail~Standard Reminder Postcard"
11263488|NCT02660788|OG001|Outcome|Family Physician Reminder Letter Arm|"Mail~Standard Reminder Postcard~Family Physician Reminder Letter"
11263489|NCT02660788|EG000|Reported Event|Control Arm|"Mail~Standard Reminder Postcard"
11263490|NCT02660788|EG001|Reported Event|Family Physician Reminder Letter Arm|"Mail~Standard Reminder Postcard~Family Physician Reminder Letter"
11263491|NCT02660801|BG000|Baseline|All Participants|"Experimental group 1: spinal manipulation, spinal mobilization Participants first received spinal manipulation. After a washout period of 48h, they then received a spinal mobilization at the same spinal level.~Experimental group 2: spinal mobilization, spinal manipulation Participants first received spinal mobilization. After a washout period of 48h, they then received a spinal manipulation at the same spinal level."
11263492|NCT02660801|FG000|Participant Flow|Spinal Manipulation Then Spinal Mobilization|"Participants first received spinal manipulation*. After a washout period of 48h, they then received a spinal mobilization* at the same spinal level.~*Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)"
11263493|NCT02660801|FG001|Participant Flow|Spinal Mobilization Then Spinal Manipulation|"Participants first received spinal mobilization*. After a washout period of 48h, they then received a spinal manipulation* at the same spinal level.~*Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)"
11263494|NCT02660801|OG000|Outcome|Spinal Manipulation|SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
11263495|NCT02660801|OG001|Outcome|Spinal Mobilization|SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
11263496|NCT02660801|EG000|Reported Event|Spinal Manipulation Then Spinal Mobilization|"11 participants with chronic nonspecific middle back pain will participate in two experimental sessions. During the first session, each participant received either a spinal manipulation of their thoracic spine preceded and followed by the assessment of their thoracic spine stiffness. The second session (24 to 48h after) will be identical but with spinal mobilization.~Spinal manipulation: A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra~Spinal mobilization: Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra"
11263497|NCT02660801|EG001|Reported Event|Spinal Mobilization Then Spinal Manipulation|"11 participants with chronic nonspecific middle back pain will participate in two experimental sessions. During the first session, each participant received a spinal mobilization of their thoracic spine preceded and followed by the assessment of their thoracic spine stiffness. The second session (24 to 48h after) will be identical but with spinal manipulation .~Spinal manipulation: A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra~Spinal mobilization: Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra"
11263498|NCT02660853|BG000|Baseline|Severe Asthma|Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
11263499|NCT02660853|FG000|Participant Flow|Severe Asthma|Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines, Observational study
11263500|NCT02660853|OG000|Outcome|Severe Asthma|Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
11263501|NCT02660853|EG000|Reported Event|Severe Asthma|Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
11263502|NCT02660918|BG000|Baseline|Control|"Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.~Normal Saline: Equal volume injection of normal saline with the same paracervical technique"
11263503|NCT02660918|BG001|Baseline|Treatment|"Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.~Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure"
11263504|NCT02660918|BG002|Baseline|Total|Total of all reporting groups
11263505|NCT02660918|FG000|Participant Flow|Treatment|"Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.~Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure"
11263506|NCT02660918|FG001|Participant Flow|Control|"Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.~Normal Saline: Equal volume injection of normal saline with the same paracervical technique"
11263507|NCT02660918|OG000|Outcome|Control|"Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.~Normal Saline: Equal volume injection of normal saline with the same paracervical technique"
11263508|NCT02660918|OG001|Outcome|Treatment|"Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.~Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure"
11263509|NCT02660918|OG000|Outcome|Control|"Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.~Normal Saline: Equal volume injection of normal saline with the same paracervical technique"
11263510|NCT02660918|EG000|Reported Event|Control|"Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.~Normal Saline: Equal volume injection of normal saline with the same paracervical technique"
11337463|NCT03585712|OG002|Outcome|CMS: Missed Pill Period|"Subjects who had at least 7 cervical mucus scores in:~Arm A: Treatment Period 3~Arm B: Treatment Period 2"
11263511|NCT02660918|EG001|Reported Event|Treatment|"Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.~Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure"
11263512|NCT02660944|BG000|Baseline|RSLV-132|"10 mg/kg RSLV-132~RSLV-132: RNase-Fc fusion protein"
11263513|NCT02660944|BG001|Baseline|Placebo|"Saline placebo~Placebo: Saline placebo"
11263514|NCT02660944|BG002|Baseline|Total|Total of all reporting groups
11263515|NCT02660944|FG000|Participant Flow|RSLV-132|"10 mg/kg RSLV-132~RSLV-132: RNase-Fc fusion protein"
11263516|NCT02660944|FG001|Participant Flow|Placebo|"Saline placebo~Placebo: Saline placebo"
11263517|NCT02660944|OG000|Outcome|RSLV-132|"10 mg/kg RSLV-132~RSLV-132: RNase-Fc fusion protein"
11263518|NCT02660944|OG001|Outcome|Placebo|"Saline placebo~Placebo: Saline placebo"
11263519|NCT02660944|EG000|Reported Event|RSLV-132|"10 mg/kg RSLV-132~RSLV-132: RNase-Fc fusion protein"
11263520|NCT02660944|EG001|Reported Event|Placebo|"Saline placebo~Placebo: Saline placebo"
11263521|NCT02660983|BG000|Baseline|Double Blind (DB) Phase: Placebo|Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263522|NCT02660983|BG001|Baseline|Double Blind (DB) Phase: Donepezil|Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263523|NCT02660983|BG002|Baseline|Total|Total of all reporting groups
11263524|NCT02660983|FG000|Participant Flow|Placebo in DB Phase Then Donepezil in OLE Phase|Participants received placebo matched to donepezil 5 milligram (mg) tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in Double Blind (DB) Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the Open Label Extension (OLE) Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 milligram per day (mg/day) up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
11263525|NCT02660983|FG001|Participant Flow|Donepezil in DB Phase Then Donepezil in OLE Phase|Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the OLE Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
11263526|NCT02660983|OG000|Outcome|Double Blind (DB) Phase: Placebo|Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263527|NCT02660983|OG001|Outcome|Double Blind (DB) Phase: Donepezil|Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263528|NCT02660983|EG000|Reported Event|Double Blind (DB) Phase: Placebo|Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263529|NCT02660983|EG001|Reported Event|Double Blind (DB) Phase: Donepezil|Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
11263530|NCT02660983|EG002|Reported Event|Open Label Extension (OLE) Phase: Donepezil|Participants who completed DB phase and consented to continue their participation in the study, were enrolled in OLE phase. In OLE phase, initially all participants received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
11263531|NCT02661061|BG000|Baseline|Ketamine|"Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart."
11263532|NCT02661061|BG001|Baseline|Midazolam|"Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart."
11263533|NCT02661061|BG002|Baseline|Total|Total of all reporting groups
11263534|NCT02661061|FG000|Participant Flow|Ketamine|"Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart."
11263535|NCT02661061|FG001|Participant Flow|Midazolam|"Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart."
11263536|NCT02661061|OG000|Outcome|Ketamine|"Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart."
11263537|NCT02661061|OG001|Outcome|Midazolam|"Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart."
11263538|NCT02661061|EG000|Reported Event|Ketamine|"Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart."
11263539|NCT02661061|EG001|Reported Event|Midazolam|"Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart."
11263540|NCT02661126|BG000|Baseline|Moderate RI Participants|Participants with an eGFR of ≥30 mL/min/1.73m^2 to <60 mL/min/1.73m^2 took 2 MK-3682B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263541|NCT02661126|BG001|Baseline|Healthy Participants|Healthy participants (CLcr ≥80 mL/min) took 2 MK-362B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263542|NCT02661126|BG002|Baseline|Total|Total of all reporting groups
11263543|NCT02661126|FG000|Participant Flow|Moderate RI Participants|Participants with an eGFR of ≥30 mL/min/1.73m^2 to <60 mL/min/1.73m^2 took 2 MK-3682B fixed dose combination (FDC) tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263544|NCT02661126|FG001|Participant Flow|Healthy Participants|Healthy participants (creatinine clearance [CLcr] ≥80 mL/min) took 2 MK-362B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263545|NCT02661126|OG000|Outcome|Moderate RI Participants|Participants with an eGFR of ≥30 mL/min/1.73m^2 to <60 mL/min/1.73m^2 took 2 MK-3682B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263546|NCT02661126|OG001|Outcome|Healthy Participants|Healthy participants (CLcr ≥80 mL/min) took 2 MK-362B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263547|NCT02661126|EG000|Reported Event|Moderate RI Participants|Participants with an eGFR of ≥30 mL/min/1.73m^2 to <60 mL/min/1.73m^2 took 2 MK-3682B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263548|NCT02661126|EG001|Reported Event|Healthy Participants|Healthy participants (CLcr ≥80 mL/min) took 2 MK-362B FDC tablets (225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir per tablet) on Day 1 after fasting for 10 hours.
11263549|NCT02661178|BG000|Baseline|Emodepside 0.1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263550|NCT02661178|BG001|Baseline|Emodepside 1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263551|NCT02661178|BG002|Baseline|Emodepside 2.5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263552|NCT02661178|BG003|Baseline|Emodepside 5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263553|NCT02661178|BG004|Baseline|Emodepside 5mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263554|NCT02661178|BG005|Baseline|Emodepside 10mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263555|NCT02661178|BG006|Baseline|Emodepside 20mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263556|NCT02661178|BG007|Baseline|Emodepside 20mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263557|NCT02661178|BG008|Baseline|Emodepside 40mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263558|NCT02661178|BG009|Baseline|Placebo Solution, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263559|NCT02661178|BG010|Baseline|Placebo Tablet, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263560|NCT02661178|BG011|Baseline|Emodepside 10mg Solution, Fed (Part 2)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11337464|NCT03585712|OG000|Outcome|CP/R&L: Reported Perfect Use Period (Treatment Period 1)|Subjects in Treatment Period 1 who had a OS + enough CMS to assess their Conception Protection Risk & Level in either Treatment Period 2 or Treatment Period 3
11263561|NCT02661178|BG012|Baseline|Emodepside 40mg Solution, Fasted, AE Follow-up Arm (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263562|NCT02661178|BG013|Baseline|Placebo Solution, Fed (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263563|NCT02661178|BG014|Baseline|Placebo Solution, Fasted (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263564|NCT02661178|BG015|Baseline|Total|Total of all reporting groups
11263565|NCT02661178|FG000|Participant Flow|Emodepside 0.1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263566|NCT02661178|FG001|Participant Flow|Emodepside 1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263567|NCT02661178|FG002|Participant Flow|Emodepside 2.5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263568|NCT02661178|FG003|Participant Flow|Emodepside 5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263569|NCT02661178|FG004|Participant Flow|Emodepside 5mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263570|NCT02661178|FG005|Participant Flow|Emodepside 10mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263571|NCT02661178|FG006|Participant Flow|Emodepside 20mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263572|NCT02661178|FG007|Participant Flow|Emodepside 20mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263573|NCT02661178|FG008|Participant Flow|Emodepside 40mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263574|NCT02661178|FG009|Participant Flow|Placebo Solution, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263575|NCT02661178|FG010|Participant Flow|Placebo Tablet, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263576|NCT02661178|FG011|Participant Flow|Emodepside 10mg Solution, Fed (Part 2)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263577|NCT02661178|FG012|Participant Flow|Emodepside 40mg Solution, Fasted, (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263578|NCT02661178|FG013|Participant Flow|Placebo Solution, Fed (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263579|NCT02661178|FG014|Participant Flow|Placebo Solution, Fasted (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263580|NCT02661178|OG000|Outcome|Emodepside 0.1mg Solution, Fasted (Part 1)|No AEs were reported for Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state
11263581|NCT02661178|OG001|Outcome|Emodepside 1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263582|NCT02661178|OG002|Outcome|Emodepside 2.5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263583|NCT02661178|OG003|Outcome|Emodepside 5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263584|NCT02661178|OG004|Outcome|Emodepside 5mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263585|NCT02661178|OG005|Outcome|Emodepside 10mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263586|NCT02661178|OG006|Outcome|Emodepside 20mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263587|NCT02661178|OG007|Outcome|Emodepside 20mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263588|NCT02661178|OG008|Outcome|Emodepside 40mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263589|NCT02661178|OG009|Outcome|Emodepside 10mg Solution, Fed (Part 2)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263590|NCT02661178|OG010|Outcome|Emodepside 40mg Solution, Fasted, (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263591|NCT02661178|OG011|Outcome|Placebo Solution, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263592|NCT02661178|OG012|Outcome|Placebo Tablet, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263593|NCT02661178|OG013|Outcome|Placebo Solution, Fed (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263594|NCT02661178|OG014|Outcome|Placebo Solution, Fasted (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263595|NCT02661178|OG000|Outcome|Emodepside 0.1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263596|NCT02661178|OG000|Outcome|Emodepside 40mg Solution, Fasted, (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263597|NCT02661178|OG001|Outcome|Placebo Solution, Fasted (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263598|NCT02661178|OG000|Outcome|Emodepside 1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263599|NCT02661178|OG001|Outcome|Emodepside 2.5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263600|NCT02661178|OG002|Outcome|Emodepside 5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263601|NCT02661178|OG003|Outcome|Emodepside 5mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263602|NCT02661178|OG004|Outcome|Emodepside 10mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263603|NCT02661178|OG005|Outcome|Emodepside 20mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263604|NCT02661178|OG006|Outcome|Emodepside 20mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263605|NCT02661178|OG007|Outcome|Emodepside 40mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263606|NCT02661178|OG008|Outcome|Emodepside 10mg Solution, Fed (Part 2)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263607|NCT02661178|OG009|Outcome|Emodepside 40mg Solution, Fasted, (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263608|NCT02661178|OG010|Outcome|Emodepside 0.1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263609|NCT02661178|OG000|Outcome|Emodepside 5mg Solution Versus Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution versus tablet, administered in fasted state Part one of study
11263610|NCT02661178|OG001|Outcome|Emodepside 20mg Solution Versus Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution versus tablet, administered in fasted state Part one of study
11263611|NCT02661178|OG000|Outcome|Emodepside 10mg Solution Fasted|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state
11263612|NCT02661178|OG001|Outcome|Emodepside 10mg Solution Fed|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state
11263613|NCT02661178|EG000|Reported Event|Emodepside 0.1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 0.1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263614|NCT02661178|EG001|Reported Event|Emodepside 1mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 1mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263615|NCT02661178|EG002|Reported Event|Emodepside 2.5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 2.5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263616|NCT02661178|EG003|Reported Event|Emodepside 5mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263617|NCT02661178|EG004|Reported Event|Emodepside 5mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 5mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263618|NCT02661178|EG005|Reported Event|Emodepside 10mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263619|NCT02661178|EG006|Reported Event|Emodepside 20mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263620|NCT02661178|EG007|Reported Event|Emodepside 20mg Tablet, Fasted (Part 1)|Emodepside (BAY 44-4400) 20mg tablet (immediate release), administered in fasted state Part one of study (FIH, single ascending dose phase)
11263621|NCT02661178|EG008|Reported Event|Emodepside 40mg Solution, Fasted (Part 1)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263622|NCT02661178|EG009|Reported Event|Emodepside 10mg Solution, Fed (Part 2)|Emodepside (BAY 44-4400) 10mg solution, as oral liquid service formulation, administered in fed state This cohort was not classed as first in human Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263623|NCT02661178|EG010|Reported Event|Emodepside 40mg Solution, Fasted, (Part 2)|Emodepside (BAY 44-4400) 40mg solution, as oral liquid service formulation, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263624|NCT02661178|EG011|Reported Event|Placebo Solution, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263625|NCT02661178|EG012|Reported Event|Placebo Tablet, Fasted (Part 1)|Matching placebo of emodepside (BAY 44-4400), tablet, administered in fasted state Part one of study (FIH, single ascending dose phase)
11263626|NCT02661178|EG013|Reported Event|Placebo Solution, Fed (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fed state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263627|NCT02661178|EG014|Reported Event|Placebo Solution, Fasted (Part 2)|Matching placebo of emodepside (BAY 44-4400), solution, administered in fasted state Part two of study (not FIH, exploratory effect of food on the bioavailability of emodepside and to assess relationship between emodepside and adverse events)
11263628|NCT02661217|BG000|Baseline|LCZ696 Pre-discharge Treatment Initiation|Patients received first dose at any point after Randomization but no later than 12 h before discharge.
11263629|NCT02661217|BG001|Baseline|LCZ696 Post-discharge Treatment Initiation|Patients received first dose after discharge and up to 14 days thereafter.
11263630|NCT02661217|BG002|Baseline|Total|Total of all reporting groups
11263631|NCT02661217|FG000|Participant Flow|LCZ696 Pre-discharge Treatment Initiation|Patients received first dose at any point after Randomization but no later than 12 h before discharge.
11263632|NCT02661217|FG001|Participant Flow|LCZ696 Post-discharge Treatment Initiation|Patients received first dose after discharge and up to 14 days thereafter.
11263633|NCT02661217|OG000|Outcome|LCZ696 Pre-discharge Treatment Initiation|Patients received first dose at any point after Randomization but no later than 12 h before discharge.
11263634|NCT02661217|OG001|Outcome|LCZ696 Post-discharge Treatment Initiation|Patients received first dose after discharge and up to 14 days thereafter.
11263635|NCT02661217|EG000|Reported Event|Pre-discharge|Pre-discharge
11263636|NCT02661217|EG001|Reported Event|Post-discharge|Post-discharge
11263637|NCT02661217|EG002|Reported Event|All Patients|All patients
11263638|NCT02661256|BG000|Baseline|VFSS on nCPAP Then Off nCPAP|"Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed on NCPAP swallows. The swallows were assessed in real time for any swallowing dysfunction.~Immediately following the on NCPAP condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed off NCPAP swallows."
11263639|NCT02661256|FG000|Participant Flow|VFSS on nCPAP Then Off nCPAP|"Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed on NCPAP swallows. The swallows were assessed in real time for any swallowing dysfunction.~Immediately following the on NCPAP condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed off NCPAP swallows."
11263640|NCT02661256|OG000|Outcome|on NCPAP|"Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed on NCPAP swallows. The swallows were assessed in real time for any swallowing dysfunction.~NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.~Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy."
11263641|NCT02661256|OG001|Outcome|Off NCPAP|"Immediately following the on NCPAP condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed off NCPAP swallows.~NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.~Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy."
11263642|NCT02661256|EG000|Reported Event|on NCPAP|"Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed on NCPAP swallows. The swallows were assessed in real time for any swallowing dysfunction.~NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.~Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy."
11263643|NCT02661256|EG001|Reported Event|Off NCPAP|"Immediately following the on NCPAP condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed off NCPAP swallows.~NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.~Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy."
11263644|NCT02661490|BG000|Baseline|Arm 1: NoV Vaccine Formulation A_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
11263645|NCT02661490|BG001|Baseline|Arm 2: NoV Vaccine Formulation A_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
11263646|NCT02661490|BG002|Baseline|Arm 3: NoV Vaccine Formulation B_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
11263647|NCT02661490|BG003|Baseline|Arm 4: NoV Vaccine Formulation B_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
11263648|NCT02661490|BG004|Baseline|Arm 5: NoV Vaccine Formulation A_1-Dose|Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
11263649|NCT02661490|BG005|Baseline|Total|Total of all reporting groups
11263650|NCT02661490|FG000|Participant Flow|Arm 1: NoV Vaccine Formulation A_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
11263651|NCT02661490|FG001|Participant Flow|Arm 2: NoV Vaccine Formulation A_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
11263652|NCT02661490|FG002|Participant Flow|Arm 3: NoV Vaccine Formulation B_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
11263653|NCT02661490|FG003|Participant Flow|Arm 4: NoV Vaccine Formulation B_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
11263654|NCT02661490|FG004|Participant Flow|Arm 5: NoV Vaccine Formulation A_1-Dose|Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
11263655|NCT02661490|OG000|Outcome|Arm 1: NoV Vaccine Formulation A_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
11263656|NCT02661490|OG001|Outcome|Arm 2: NoV Vaccine Formulation A_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
11263657|NCT02661490|OG002|Outcome|Arm 3: NoV Vaccine Formulation B_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
11263658|NCT02661490|OG003|Outcome|Arm 4: NoV Vaccine Formulation B_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
11263659|NCT02661490|OG004|Outcome|Arm 5: NoV Vaccine Formulation A_1-Dose|Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
11263660|NCT02661490|EG000|Reported Event|Arm 1: NoV Vaccine Formulation A_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
11263661|NCT02661490|EG001|Reported Event|Arm 2: NoV Vaccine Formulation A_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
11263662|NCT02661490|EG002|Reported Event|Arm 3: NoV Vaccine Formulation B_1-Dose|Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
11263663|NCT02661490|EG003|Reported Event|Arm 4: NoV Vaccine Formulation B_2-Dose|Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
11263664|NCT02661490|EG004|Reported Event|Arm 5: NoV Vaccine Formulation A_1-Dose|Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
11263665|NCT02661594|BG000|Baseline|ABCD|A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo.
11263666|NCT02661594|BG001|Baseline|BDAC|B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg.
11263667|NCT02661594|BG002|Baseline|CADB|C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg
11263668|NCT02661594|BG003|Baseline|DCBA|D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg
11263669|NCT02661594|BG004|Baseline|Total|Total of all reporting groups
11263670|NCT02661594|FG000|Participant Flow|ABCD|A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo
11263671|NCT02661594|FG001|Participant Flow|BDAC|B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg.
11263672|NCT02661594|FG002|Participant Flow|CADB|C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg
11263673|NCT02661594|FG003|Participant Flow|DCBA|D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg
11263674|NCT02661594|OG000|Outcome|5 mg IV APD421|Single dose of 5 mg IV APD421 infused over 2 minutes
10848134|NCT00288639|EG000|Reported Event|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
11263675|NCT02661594|OG001|Outcome|40 mg IV APD421|Single dose of 40 mg IV APD421 infused over 2 minutes
11263676|NCT02661594|OG002|Outcome|Placebo|IV placebo infused over 8 minutes
11263677|NCT02661594|OG003|Outcome|Oral Moxifloxacin|Single 400 mg oral dose of moxifloxacin
11263678|NCT02661594|EG000|Reported Event|Placebo|"Intravenous placebo: two infusions in parallel, one over 2 minutes, one over 8 minutes~Placebo: Placebo comparator to establish baseline for calculating change in QTcF"
11263679|NCT02661594|EG001|Reported Event|Amisulpride 5 mg|"Intravenous amisulpride 5 mg: infusion over 2 minutes; Intravenous placebo infused in parallel over 8 minutes~Amisulpride 5 mg: Therapeutic dose of amisulpride"
11263680|NCT02661594|EG002|Reported Event|Amisulpride 40 mg|"Intravenous amisulpride 40 mg: infusion over 8 minutes;~Intravenous placebo infused in parallel over 2 minutes~Amisulpride 40 mg: Supra-therapeutic dose of amisulpride"
11263681|NCT02661594|EG003|Reported Event|Moxifloxacin|"Oral moxifloxacin 400 mg tablet administered once (not blinded)~Moxifloxacin: Positive control for assay sensitivity"
11263682|NCT02661737|BG000|Baseline|YVOIRE Volume s|"YVOIRE volume s~YVOIRE volume s"
11263683|NCT02661737|FG000|Participant Flow|YVOIRE Volume s|"YVOIRE volume s~YVOIRE volume s"
10848135|NCT00288704|BG000|Baseline|Placebo|
10848136|NCT00288704|BG001|Baseline|Rilonacept 160 mg|
11263684|NCT02661737|OG000|Outcome|YVOIRE Volume s|"YVOIRE volume s~YVOIRE volume s"
11263685|NCT02661737|EG000|Reported Event|YVOIRE Volume s|"YVOIRE volume s~YVOIRE volume s"
11263686|NCT02661815|BG000|Baseline|Phase 1 Expansion Cohort A|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263687|NCT02661815|BG001|Baseline|Phase 1 Expansion Cohort B|"Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263688|NCT02661815|BG002|Baseline|Phase 1 Expansion Cohort C|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description.~Bevacizumab: Please see arm/group description."
11263689|NCT02661815|BG003|Baseline|Phase 1 Escalation Cohort|"Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263690|NCT02661815|BG004|Baseline|Total|Total of all reporting groups
11263691|NCT02661815|FG000|Participant Flow|Phase 1 Escalation Cohort|"Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263692|NCT02661815|FG001|Participant Flow|Phase 1 Expansion Cohort A|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263693|NCT02661815|FG002|Participant Flow|Phase 1 Expansion Cohort B|"Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263694|NCT02661815|FG003|Participant Flow|Phase 1 Expansion Cohort C|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description.~Bevacizumab: Please see arm/group description."
11263695|NCT02661815|OG000|Outcome|Phase 1 Escalation Cohort|"Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263696|NCT02661815|OG001|Outcome|Phase 1 Expansion Cohort A|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263697|NCT02661815|OG002|Outcome|Phase 1 Expansion Cohort B|"Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263698|NCT02661815|OG003|Outcome|Phase 1 Expansion Cohort C|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description.~Bevacizumab: Please see arm/group description."
11337465|NCT03585712|OG001|Outcome|CP/R&L: Delayed Pill Period|"Subjects who had a OS + enough CMS to asses their Conception Protection Risk & Level in:~Arm A: Treatment Period 2~Arm B: Treatment Period 3"
11263699|NCT02661815|OG000|Outcome|Phase 1 Expansion Cohort A|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263700|NCT02661815|OG001|Outcome|Phase 1 Expansion Cohort B|"Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263701|NCT02661815|OG002|Outcome|Phase 1 Expansion Cohort C|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description.~Bevacizumab: Please see arm/group description."
11263702|NCT02661815|OG003|Outcome|Phase 1 Escalation Cohort|"Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263703|NCT02661815|EG000|Reported Event|Phase 1 Expansion Cohort A|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263704|NCT02661815|EG001|Reported Event|Phase 1 Expansion Cohort B|"Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263705|NCT02661815|EG002|Reported Event|Phase 1 Expansion Cohort C|"Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description.~Bevacizumab: Please see arm/group description."
11263706|NCT02661815|EG003|Reported Event|Phase 1 Escalation Cohort|"Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).~Paclitaxel: Please see arm/group description.~Ricolinostat: Please see arm/group description."
11263707|NCT02661828|BG000|Baseline|Taper A Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a Two-Week Taper Regimen to discontinue their medication.~Two-Week Antidepressant Taper Regimen: Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant."
11263708|NCT02661828|BG001|Baseline|Taper B Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a One-Week Taper Regimen to discontinue their medication.~One-Week Antidepressant Taper Regimen: Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant."
11263709|NCT02661828|BG002|Baseline|Total|Total of all reporting groups
11263710|NCT02661828|FG000|Participant Flow|Taper A Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a Two-Week Taper Regimen to discontinue their medication.~Two-Week Antidepressant Taper Regimen: Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant."
11263711|NCT02661828|FG001|Participant Flow|Taper B Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a One-Week Taper Regimen to discontinue their medication.~One-Week Antidepressant Taper Regimen: Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant."
11263712|NCT02661828|OG000|Outcome|Taper A Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a Two-Week Taper Regimen to discontinue their medication.~Two-Week Antidepressant Taper Regimen: Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant."
11263713|NCT02661828|EG000|Reported Event|Taper A Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a Two-Week Taper Regimen to discontinue their medication.~Two-Week Antidepressant Taper Regimen: Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant."
11263714|NCT02661828|EG001|Reported Event|Taper B Regimen|"Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a One-Week Taper Regimen to discontinue their medication.~One-Week Antidepressant Taper Regimen: Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant."
11263715|NCT02662023|BG000|Baseline|Right Side of the Body Randomized to Bolus|"Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h~Perineural ropivacaine administration.~Since it's a split body study ,left side of the body of these participants simultaneously received Ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) x 6 h."
11263716|NCT02662023|BG001|Baseline|Right Side of the Body Randomized to Basal|"Ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h~Perineural ropivacaine administration.~Since it's a split body study, left side of these participants simultenously received Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h."
11263717|NCT02662023|BG002|Baseline|Total|Total of all reporting groups
11263718|NCT02662023|FG000|Participant Flow|Right Side of the Body Randomized to Bolus|"Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h~Perineural ropivacaine administration.~Since it's a split body study ,left side of the body of these participants received Ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) x 6 h."
11263719|NCT02662023|FG001|Participant Flow|Right Side of the Body Randomized to Basal|"Ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h~Perineural ropivacaine administration.~Since it's a split body study, left side of these participants received Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h"
11263720|NCT02662023|OG000|Outcome|Bolus|"ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h~perineural ropivacaine administration"
11263721|NCT02662023|OG001|Outcome|Basal|"ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h~perineural ropivacaine administration"
11263722|NCT02662023|EG000|Reported Event|Bolus|"ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h~perineural ropivacaine administration"
11263723|NCT02662023|EG001|Reported Event|Basal|"ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h~perineural ropivacaine administration"
11263724|NCT02662036|BG000|Baseline|Group 1: Bupivicaine|-TAP block of 30 cc of 0.25% bupivicaine
11263725|NCT02662036|BG001|Baseline|Group 2: Liposomal Bupivacaine|-TAP block of 266 mg/30 cc liposomal bupivacaine
11263726|NCT02662036|BG002|Baseline|Total|Total of all reporting groups
11263727|NCT02662036|FG000|Participant Flow|Group 1: Bupivicaine|-TAP block of 30 cc of 0.25% bupivicaine
11263728|NCT02662036|FG001|Participant Flow|Group 2: Liposomal Bupivacaine|-TAP block of 266 mg/30 cc liposomal bupivacaine
11263729|NCT02662036|OG000|Outcome|Group 1: Bupivicaine|-TAP block of 30 cc of 0.25% bupivicaine
11263730|NCT02662036|OG001|Outcome|Group 2: Liposomal Bupivacaine|-TAP block of 266 mg/30 cc liposomal bupivacaine
11263731|NCT02662036|EG000|Reported Event|Group 1: Bupivicaine|-TAP block of 30 cc of 0.25% bupivicaine
11263732|NCT02662036|EG001|Reported Event|Group 2: Liposomal Bupivacaine|-TAP block of 266 mg/30 cc liposomal bupivacaine
11263733|NCT02662244|BG000|Baseline|Yag Laser Treatment Of Basal Cell Carcinoma|"Thirty-one subjects seeking treatment for biopsy-proven BCC that did not meet the criteria for Mohs surgery were recruited. Subjects on current anticoagulation therapy, or with a history of immunosuppression were excluded. Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC. Standardized photographs and adverse assessments were taken at the baseline visit, immediately after laser treatment and on the day of excision.~Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma"
11263734|NCT02662244|FG000|Participant Flow|All Participants|Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC.
11263735|NCT02662244|OG000|Outcome|Single Arm|"Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype.~Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma"
11263736|NCT02662244|OG000|Outcome|All Participants|Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC.
11263737|NCT02662244|OG000|Outcome|All Participants|"Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC.~30 to 90 days after laser treatment, all subjects are required to return for excision of the tumor site as located and recorded at the time of the first treatment. At this final follow-up visit, there is no will be no laser treatment. The following procedures and assessments will be performed.~The lesional areas to be treated will be located. A record of the size of the lesional area will be made.~The lesional area will be photographed.~The treatment area will be assessed for purpura, edema, erythema, scar or blistering using the following scale:~0 = absence~1 = mild~2 = moderate~3 = severe"
11263738|NCT02662244|EG000|Reported Event|Yag Laser Treatment Of Basal Cell Carcinoma|"Single arm/group study~Study participants will be treated with a long-pulsed 1064 nm Nd:YAG laser with a 5-7 mm spot, an approximate fluence of 100-200 J/cm2 and a pulse duration of 3-15ms determined somewhat at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. There will be no randomization."
11263739|NCT02662387|BG000|Baseline|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
11263740|NCT02662387|BG001|Baseline|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
11263741|NCT02662387|BG002|Baseline|Total|Total of all reporting groups
11263742|NCT02662387|FG000|Participant Flow|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
11263743|NCT02662387|FG001|Participant Flow|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
11263744|NCT02662387|OG000|Outcome|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS"
11263745|NCT02662387|OG001|Outcome|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS"
11263746|NCT02662387|OG000|Outcome|HFNC Group|High flow nasal cannula alone without external nasal dilator
11263747|NCT02662387|OG001|Outcome|HFNC With END|High flow nasal cannula with external nasal dilator
11263748|NCT02662387|EG000|Reported Event|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
11263749|NCT02662387|EG001|Reported Event|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator~External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen~High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
11337466|NCT03585712|OG002|Outcome|CP/R&L: Missed Pill Period|"Subjects who had a OS + enough CMS to assess their Conception Protection Risk & Level in:~Arm A: Treatment Period 3~Arm B: Treatment Period 2"
11263750|NCT02662556|BG000|Baseline|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11263751|NCT02662556|FG000|Participant Flow|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11263752|NCT02662556|OG000|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11263753|NCT02662556|OG000|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11263754|NCT02662556|EG000|Reported Event|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
11263755|NCT02662569|BG000|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263756|NCT02662569|BG001|Baseline|Placebo QM|Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263757|NCT02662569|BG002|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263758|NCT02662569|BG003|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263759|NCT02662569|BG004|Baseline|Total|Total of all reporting groups
11263760|NCT02662569|FG000|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263761|NCT02662569|FG001|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263762|NCT02662569|FG002|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263763|NCT02662569|FG003|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263764|NCT02662569|OG000|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263765|NCT02662569|OG001|Outcome|Placebo QM|Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263766|NCT02662569|OG002|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263767|NCT02662569|OG003|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263768|NCT02662569|EG000|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263769|NCT02662569|EG001|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263770|NCT02662569|EG002|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263771|NCT02662569|EG003|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
11263772|NCT02662582|BG000|Baseline|CK-2127107 1000mg, Then Placebo|Participants received CK-2127107 500 mg, orally, twice daily for 2 weeks in treatment period 1 followed by matching placebo orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks will be maintained between the two treatment periods.
11263773|NCT02662582|BG001|Baseline|Placebo, Then CK-2127107 1000mg|Participants received matching placebo orally, twice daily for 2 weeks in treatment period 1 followed by CK-2127107 500 mg, orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks will be maintained between the two treatment periods.
11263774|NCT02662582|BG002|Baseline|Total|Total of all reporting groups
11263775|NCT02662582|FG000|Participant Flow|CK-2127107 1000 mg, Then Placebo|Participants received CK-2127107 500 mg, orally, twice daily for 2 weeks in treatment period 1 followed by matching placebo orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods.
11263776|NCT02662582|FG001|Participant Flow|Placebo, Then CK-212710 1000 mg|Participants received matching placebo orally, twice daily for 2 weeks in treatment period 1 followed by CK-2127107 500 mg orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods.
11263777|NCT02662582|OG000|Outcome|Placebo|Participants received matching placebo orally, twice daily for 2 weeks in treatment periods 1 and 2.
11263778|NCT02662582|OG001|Outcome|CK-2127107|Participants received CK-2127107 500 mg orally twice daily for 2 weeks in treatment periods 1 and 2.
11263779|NCT02662582|OG000|Outcome|CK-2127107|Participants received CK-2127107 500 mg orally twice daily for 2 weeks in treatment periods 1 and 2.
11263780|NCT02662582|EG000|Reported Event|Placebo|Participants received matching placebo orally, twice daily for 2 weeks in treatment periods 1 and 2.
11263781|NCT02662582|EG001|Reported Event|CK-2127107|Participants received CK-2127107 500 mg orally twice daily for 2 weeks in treatment periods 1 and 2.
11263782|NCT02662608|BG000|Baseline|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11263783|NCT02662608|FG000|Participant Flow|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11263784|NCT02662608|OG000|Outcome|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11263785|NCT02662608|EG000|Reported Event|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
11263786|NCT02662764|BG000|Baseline|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
11263787|NCT02662764|FG000|Participant Flow|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
11263788|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
11263789|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|"Zalviso™(sufentanil sublingual tablet system) 15 mcg~Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for up to 72 hours"
11263790|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|"Zalviso™(sufentanil sublingual tablet system) 15 mcg~Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours"
11263791|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
11263792|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
11263793|NCT02662764|OG000|Outcome|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for at least 24 hours and up to 72 hours.
11263794|NCT02662764|EG000|Reported Event|Zalviso™ 15 mcg|Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
11263795|NCT02663128|BG000|Baseline|18 to 55 Years|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group
11263796|NCT02663128|BG001|Baseline|> 55 Years|LY3314814 (AZD3293): 50 mg administered once orally PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group
11263797|NCT02663128|BG002|Baseline|Total|Total of all reporting groups
11263798|NCT02663128|FG000|Participant Flow|Sequence 1|LY3314814 (AZD3293): 50 milligram (mg) administered once orally (PO) in each of 3 treatment periods. Treatment sequence: Reference (R [Fasted])/ Test (T [Fasted])/ T (Fed)
11263799|NCT02663128|FG001|Participant Flow|Sequence 2|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: T (Fasted)/T (Fed)/ R (Fasted)
11263800|NCT02663128|FG002|Participant Flow|Sequence 3|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fed)/ R (Fasted)/ T (Fasted)
11263801|NCT02663128|FG003|Participant Flow|Sequence 4|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T(Fed)/ T (Fasted)/ R (Fasted)
11263802|NCT02663128|FG004|Participant Flow|Sequence 5|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: R (Fasted)/T (Fed)/ T (Fasted)
11263803|NCT02663128|FG005|Participant Flow|Sequence 6|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fasted)/ R (Fasted)/ T (Fed)
11263804|NCT02663128|OG000|Outcome|R (Fasted)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
11263805|NCT02663128|OG001|Outcome|T (Fasted)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group.
11263806|NCT02663128|OG002|Outcome|T (Fed)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
11263807|NCT02663128|OG001|Outcome|T (Fasted)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group
11263808|NCT02663128|EG000|Reported Event|R (Fasted)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
11263809|NCT02663128|EG001|Reported Event|T (Fasted)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group
11263810|NCT02663128|EG002|Reported Event|T (Fed)|LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
11263811|NCT02663232|BG000|Baseline|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11263812|NCT02663232|FG000|Participant Flow|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11263813|NCT02663232|OG000|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11263814|NCT02663232|EG000|Reported Event|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
11337496|NCT03586544|BG000|Baseline|Albuterol First|"Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and~Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, albuterol visit was completed first."
11263815|NCT02663453|BG000|Baseline|Study Group|"multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~multicomponent lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
11263816|NCT02663453|BG001|Baseline|Control Group|"pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~pure soybean oil lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
11263817|NCT02663453|BG002|Baseline|Total|Total of all reporting groups
11263818|NCT02663453|FG000|Participant Flow|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11263819|NCT02663453|FG001|Participant Flow|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11263820|NCT02663453|OG000|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11263821|NCT02663453|OG001|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11263822|NCT02663453|EG000|Reported Event|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
11263823|NCT02663453|EG001|Reported Event|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
11263824|NCT02663674|BG000|Baseline|Fluconazole|Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
11263825|NCT02663674|BG001|Baseline|Placebo|Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
11263826|NCT02663674|BG002|Baseline|Total|Total of all reporting groups
11263827|NCT02663674|FG000|Participant Flow|Fluconazole|Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
11263828|NCT02663674|FG001|Participant Flow|Placebo|Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
11263829|NCT02663674|OG000|Outcome|Fluconazole|Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
11263830|NCT02663674|OG001|Outcome|Placebo|Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
11263831|NCT02663674|EG000|Reported Event|Fluconazole|Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
11263832|NCT02663674|EG001|Reported Event|Placebo|Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
11263833|NCT02663687|BG000|Baseline|Placebo|Participants received placebo matched to SHP623 intravenous and subcutaneous administration in 1:3 ratio for each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between intravenous (IV) and subcutaneous (SC) dosing in the following order: once as an IV dose and once as an SC dose.
11263834|NCT02663687|BG001|Baseline|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263835|NCT02663687|BG002|Baseline|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263836|NCT02663687|BG003|Baseline|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263837|NCT02663687|BG004|Baseline|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263838|NCT02663687|BG005|Baseline|Total|Total of all reporting groups
11263839|NCT02663687|FG000|Participant Flow|Placebo|Participants received placebo matched to SHP623 intravenous (IV) and subcutaneous (SC) administration in 1:3 ratio for each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263840|NCT02663687|FG001|Participant Flow|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an subcutaneous SC dose.
11263841|NCT02663687|FG002|Participant Flow|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an subcutaneous SC dose.
11263842|NCT02663687|FG003|Participant Flow|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an subcutaneous SC dose.
11263843|NCT02663687|FG004|Participant Flow|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an subcutaneous SC dose.
11263844|NCT02663687|OG000|Outcome|Placebo|Participants received placebo matched to SHP623 intravenous (IV) and subcutaneous (SC) administration in 1:3 ratio for each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263845|NCT02663687|OG001|Outcome|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263846|NCT02663687|OG002|Outcome|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263847|NCT02663687|OG003|Outcome|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263848|NCT02663687|OG004|Outcome|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263849|NCT02663687|OG000|Outcome|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263850|NCT02663687|OG001|Outcome|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263851|NCT02663687|OG002|Outcome|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263852|NCT02663687|OG003|Outcome|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263853|NCT02663687|OG000|Outcome|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263854|NCT02663687|OG001|Outcome|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263855|NCT02663687|OG002|Outcome|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263856|NCT02663687|OG003|Outcome|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 and 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263857|NCT02663687|OG000|Outcome|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 and treatment period 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263858|NCT02663687|OG001|Outcome|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 and treatment period 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263859|NCT02663687|OG002|Outcome|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 and treatment period 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263860|NCT02663687|OG003|Outcome|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 and treatment period 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263861|NCT02663687|OG003|Outcome|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 and treatment oeriod 2 for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263862|NCT02663687|EG000|Reported Event|Placebo|Participants received placebo matched to SHP623 intravenous (IV) and subcutaneous (SC) administration in 1:3 ratio for each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263863|NCT02663687|EG001|Reported Event|1000 U SHP623|Participants received 1000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263864|NCT02663687|EG002|Reported Event|2000 U SHP623|Participants received 2000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263865|NCT02663687|EG003|Reported Event|3000 U SHP623|Participants received 3000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263866|NCT02663687|EG004|Reported Event|5000 U SHP623|Participants received 5000 unit (U) of SHP623 in each cohort during treatment period 1 (IV) and treatment period 2 (SC) for 28 days respectively with 28 days interval between IV and SC dosing in the following order: once as an IV dose and once as an SC dose.
11263867|NCT02663817|BG000|Baseline|IMRT|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
11263868|NCT02663817|FG000|Participant Flow|IMRT|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
11263869|NCT02663817|OG000|Outcome|IMRT Lung|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Lung cancer.
11263870|NCT02663817|OG001|Outcome|IMRT Prostate|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Prostate cancer.
11263871|NCT02663817|OG002|Outcome|IMRT Head and Neck|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Head-and-Neck cancer.
11263872|NCT02663817|EG000|Reported Event|IMRT|Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
11263873|NCT02663882|BG000|Baseline|Smoking-related Self Control Task|"self control practice - smoking related task~self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day"
11263874|NCT02663882|BG001|Baseline|Non-smoking-related Self Control Task|"self control practice - non-smoking related task~self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day"
11263875|NCT02663882|BG002|Baseline|Total|Total of all reporting groups
11263876|NCT02663882|FG000|Participant Flow|Smoking-related Self Control Task|"self control practice - smoking related task~self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day"
11263877|NCT02663882|FG001|Participant Flow|Non-smoking-related Self Control Task|"self control practice - non-smoking related task~self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day"
11263878|NCT02663882|OG000|Outcome|Smoking-related Self Control Task|"self control practice - smoking related task~self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day"
11263879|NCT02663882|OG001|Outcome|Non-smoking-related Self Control Task|"self control practice - non-smoking related task~self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day"
11263880|NCT02663882|EG000|Reported Event|Smoking-related Self Control Task|"self control practice - smoking related task~self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day"
11263881|NCT02663882|EG001|Reported Event|Non-smoking-related Self Control Task|"self control practice - non-smoking related task~self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day"
11263882|NCT02663895|BG000|Baseline|Oral Treprostinil|"Treprostinil 0.125 mg TID orally, which will be increased by 0.125 mg TID every 3 to 4 days as tolerated for 12 months~Oral treprostinil: Treprostinil 0.125 mg TID orally, which will be increased by 0.125 mg TID every 3 to 4 days as tolerated"
11263883|NCT02663895|FG000|Participant Flow|Oral Treprostinil|Treprostinil 0.125 mg three times daily (TID), increased by 0.125 mg TID every 3 to 4 days as tolerated for 12-month period of time.
11263884|NCT02663895|OG000|Outcome|Oral Treprostinil|Treprostinil 0.125 mg TID, increased by 0.125 mg TID every 3 to 4 days as tolerated for 12-month period of time.
11263885|NCT02663895|OG000|Outcome|Oral Treprostinil|"Treprostinil 0.125 mg TID orally, which will be increased by 0.125 mg TID every 3 to 4 days as tolerated for 12 months~Oral treprostinil: Treprostinil 0.125 mg TID orally, which will be increased by 0.125 mg TID every 3 to 4 days as tolerated"
11263886|NCT02663895|EG000|Reported Event|Oral Treprostinil|Treprostinil 0.125 mg TID, increased by 0.125 mg TID every 3 to 4 days as tolerated for 12-month period of time.
11263887|NCT02664220|BG000|Baseline|Povidone-iodine Irrigation|"Povidone-iodine irrigation: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.~1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister."
11263888|NCT02664220|BG001|Baseline|No Irrigation|No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
11263889|NCT02664220|BG002|Baseline|Total|Total of all reporting groups
11263890|NCT02664220|FG000|Participant Flow|Povidone-iodine Irrigation|"Povidone-iodine irrigation: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.~1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister."
10848137|NCT00288704|BG002|Baseline|Open-Label Rilonacept 160 mg|57 new subjects entered the study directly into the OLE. This was not part of the double blind or randomized withdrawal portion of the results. The 44 subjects who completed Parts A and B were not included in this category for baseline characteristics. Pediatric subjects , age 7 or older, received rilonacept dosed 2.2 mg/kg weekly up to 160 mg during the OLE.
11263891|NCT02664220|FG001|Participant Flow|No Irrigation|No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
11263892|NCT02664220|OG000|Outcome|Povidone-iodine Irrigation|"Povidone-iodine irrigation: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.~1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister."
11263893|NCT02664220|OG001|Outcome|No Irrigation|No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
10848138|NCT00288704|BG003|Baseline|Total|Total of all reporting groups
11263894|NCT02664220|EG000|Reported Event|Povidone-iodine Irrigation|"Povidone-iodine irrigation: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.~1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister."
11263895|NCT02664220|EG001|Reported Event|No Irrigation|No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation.
11263896|NCT02664272|BG000|Baseline|SL-PLUS™ MIA Ti/HA|Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
11263897|NCT02664272|FG000|Participant Flow|SL-PLUS™ MIA Ti/HA|Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
11263898|NCT02664272|OG000|Outcome|SL-PLUS™ MIA Ti/HA|Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
11263899|NCT02664272|EG000|Reported Event|SL-PLUS™ MIA Ti/HA|Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
11263900|NCT02664311|BG000|Baseline|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11263901|NCT02664311|BG001|Baseline|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
10970002|NCT00908375|EG000|Reported Event|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
10970003|NCT00908375|EG001|Reported Event|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
10970004|NCT00908388|BG000|Baseline|GORE Conformable TAG® Device Surgical Implant|Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
10970005|NCT00908388|FG000|Participant Flow|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
10970006|NCT00908388|OG000|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
10970007|NCT00908388|EG000|Reported Event|GORE Conformable TAG® Device Surgical Implant|
11263902|NCT02664311|BG002|Baseline|Total|Total of all reporting groups
10970008|NCT00908466|BG000|Baseline|Intravitreal Injection|"Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120."
10970009|NCT00908466|BG001|Baseline|Subconjunctival Injection|"Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120."
10970010|NCT00908466|BG002|Baseline|Total|Total of all reporting groups
11263903|NCT02664311|FG000|Participant Flow|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11263904|NCT02664311|FG001|Participant Flow|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11263905|NCT02664311|OG000|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11263906|NCT02664311|OG001|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11263907|NCT02664311|EG000|Reported Event|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
11263908|NCT02664311|EG001|Reported Event|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
11263909|NCT02664363|BG000|Baseline|EGFRvIII CAR T Cells|4.5 x 10^6 EGFRvIII CAR T Cells/kg: Autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII
11263910|NCT02664363|FG000|Participant Flow|EGFRvIII CAR T Cells|4.5 x 10^6 EGFRvIII CAR T Cells/kg - Autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII
11263911|NCT02664363|OG000|Outcome|EGFRvIII CAR T Cells|4.5 x 10^6 EGFRvIII CAR T cells/kg: Autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII
11263912|NCT02664363|EG000|Reported Event|EGFRvIII CAR T Cells|4.5 x 10^6 EGFRvIII CAR T cells/kg: Autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII
11263913|NCT02664415|BG000|Baseline|VRC01|"Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~VRC01: 40 mg/kg; administered IV"
11263914|NCT02664415|BG001|Baseline|Placebo for VRC01|"Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV"
11263915|NCT02664415|BG002|Baseline|Total|Total of all reporting groups
11263916|NCT02664415|FG000|Participant Flow|VRC01|"Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~VRC01: 40 mg/kg; administered IV"
11263917|NCT02664415|FG001|Participant Flow|Placebo for VRC01|"Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV"
11263918|NCT02664415|OG000|Outcome|VRC01|"Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~VRC01: 40 mg/kg; administered IV"
11263919|NCT02664415|OG001|Outcome|Placebo for VRC01|"Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV"
11263920|NCT02664415|EG000|Reported Event|VRC01|"Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~VRC01: 40 mg/kg; administered IV"
11263921|NCT02664415|EG001|Reported Event|Placebo for VRC01|"Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.~Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV"
11263922|NCT02664532|BG000|Baseline|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11263923|NCT02664532|BG001|Baseline|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11263924|NCT02664532|BG002|Baseline|Total|Total of all reporting groups
11263925|NCT02664532|FG000|Participant Flow|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11263926|NCT02664532|FG001|Participant Flow|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11263927|NCT02664532|OG000|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11263928|NCT02664532|OG001|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11263929|NCT02664532|EG000|Reported Event|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
11263930|NCT02664532|EG001|Reported Event|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
11263931|NCT02664610|BG000|Baseline|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11263932|NCT02664610|BG001|Baseline|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11263933|NCT02664610|BG002|Baseline|Total|Total of all reporting groups
11263934|NCT02664610|FG000|Participant Flow|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11263935|NCT02664610|FG001|Participant Flow|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11263936|NCT02664610|OG000|Outcome|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11263937|NCT02664610|OG001|Outcome|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11263938|NCT02664610|EG000|Reported Event|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
11263939|NCT02664610|EG001|Reported Event|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.~Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
11263940|NCT02664909|BG000|Baseline|Tranexamic Acid|"Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.~Tranexamic Acid"
11263941|NCT02664909|BG001|Baseline|Placebo|"Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.~Placebo (saline)"
11263942|NCT02664909|BG002|Baseline|Total|Total of all reporting groups
11263943|NCT02664909|FG000|Participant Flow|Tranexamic Acid|"Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.~Tranexamic Acid"
11263944|NCT02664909|FG001|Participant Flow|Placebo|"Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.~Placebo (saline)"
11263945|NCT02664909|OG000|Outcome|Tranexamic Acid|"Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.~Tranexamic Acid"
11263946|NCT02664909|OG001|Outcome|Placebo|"Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.~Placebo (saline)"
11263947|NCT02664909|EG000|Reported Event|Tranexamic Acid|"Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.~Tranexamic Acid"
11263948|NCT02664909|EG001|Reported Event|Placebo|"Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.~Placebo (saline)"
11263949|NCT02664922|BG000|Baseline|Sedation - Group 1|"Sedation - monitored anesthesia with propofol.~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263950|NCT02664922|BG001|Baseline|Sedation - Group 2|"Sedation - monitored anesthesia with ketamine + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263951|NCT02664922|BG002|Baseline|Sedation - Group 3|"Sedation - monitored anesthesia with remifentanil + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures."
10848139|NCT00288704|FG000|Participant Flow|Placebo|If assigned, subjects received Placebo during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). No subject received Placebo during the open-label extension (after week 24). The drug is administered subcutaneously on a weekly basis.
11263952|NCT02664922|BG003|Baseline|General Anesthesia - Group 1|"General anesthesia (GA) with Sevoflurane + O2~Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures."
11263953|NCT02664922|BG004|Baseline|Total|Total of all reporting groups
11263954|NCT02664922|FG000|Participant Flow|Sedation - Group 1|"Sedation - monitored anesthesia with propofol.~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263955|NCT02664922|FG001|Participant Flow|Sedation - Group 2|"Sedation - monitored anesthesia with ketamine + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263956|NCT02664922|FG002|Participant Flow|Sedation - Group 3|"Sedation - monitored anesthesia with remifentanil + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures."
11263957|NCT02664922|FG003|Participant Flow|General Anesthesia - Group 1|"General anesthesia (GA) with Sevoflurane + O2~Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures."
11263958|NCT02664922|OG000|Outcome|Sedation - Group 1|"Sedation - monitored anesthesia with propofol.~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263959|NCT02664922|OG001|Outcome|Sedation - Group 2|"Sedation - monitored anesthesia with ketamine + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263960|NCT02664922|OG002|Outcome|Sedation - Group 3|"Sedation - monitored anesthesia with remifentanil + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures."
11263961|NCT02664922|OG003|Outcome|General Anesthesia - Group 1|"General anesthesia (GA) with Sevoflurane + O2~Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures."
11263962|NCT02664922|EG000|Reported Event|Sedation - Group 1|"Sedation - monitored anesthesia with propofol.~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263963|NCT02664922|EG001|Reported Event|Sedation - Group 2|"Sedation - monitored anesthesia with ketamine + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Ketamine: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures."
11263964|NCT02664922|EG002|Reported Event|Sedation - Group 3|"Sedation - monitored anesthesia with remifentanil + propofol~Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.~1 of 2 sedation groups for VT ablation and afib procedures.~Remifentanil: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures."
11263965|NCT02664922|EG003|Reported Event|General Anesthesia - Group 1|"General anesthesia (GA) with Sevoflurane + O2~Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures."
11263966|NCT02664961|BG000|Baseline|TRC105 and/or Bevacizumab|"All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.~TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.~Bevacizumab: Bevacizumab will be dosed every two weeks."
11263967|NCT02664961|FG000|Participant Flow|TRC105 and/or Bevacizumab|"All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.~TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.~Bevacizumab: Bevacizumab will be dosed every two weeks."
11263968|NCT02664961|OG000|Outcome|TRC105 and/or Bevacizumab|"All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.~TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.~Bevacizumab: Bevacizumab will be dosed every two weeks."
11263969|NCT02664961|EG000|Reported Event|TRC105 and/or Bevacizumab|"All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.~TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.~Bevacizumab: Bevacizumab will be dosed every two weeks."
11263970|NCT02664987|BG000|Baseline|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11263971|NCT02664987|FG000|Participant Flow|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11263972|NCT02664987|OG000|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
11263973|NCT02664987|EG000|Reported Event|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
10970011|NCT00908466|FG000|Participant Flow|Intravitreal Injection|"Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120."
11263974|NCT02665052|BG000|Baseline|Home-based BATRAC|Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system.
11263975|NCT02665052|BG001|Baseline|Lab-based BATRAC Plus TTT|Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT).
11263976|NCT02665052|BG002|Baseline|Delayed Entry Usual Care|Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did received weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
11263977|NCT02665052|BG003|Baseline|Home-based BATRAC Caregivers|An identified caregiver provided assistance as needed for the home-based intervention.
11263978|NCT02665052|BG004|Baseline|Total|Total of all reporting groups
11263979|NCT02665052|FG000|Participant Flow|Home-based BATRAC|Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system.
11263980|NCT02665052|FG001|Participant Flow|Lab-based BATRAC Plus TTT|Lab-based BATRAC + TTT consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT).
11263981|NCT02665052|FG002|Participant Flow|Delayed Entry Usual Care|Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
11263982|NCT02665052|FG003|Participant Flow|Home-based BATRAC Caregivers|An identified caregiver provided assistance as needed for the home-based intervention.
11263983|NCT02665052|OG000|Outcome|Home-Based BATRAC|Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The BATRAC training included high intensity bilateral reaching and rest periods. The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system.
11263984|NCT02665052|OG001|Outcome|Lab-based BATRAC Plus TTT|Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT).
11263985|NCT02665052|OG002|Outcome|Delayed Entry Usual Care|Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except for protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
11263986|NCT02665052|OG000|Outcome|Home-Based BATRAC|Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system.
11263987|NCT02665052|OG002|Outcome|Delayed Entry Usual Care|Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
11263988|NCT02665052|EG000|Reported Event|Home-based BATRAC|Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system.
11263989|NCT02665052|EG001|Reported Event|Lab-based BATRAC Plus TTT|Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT).
11263990|NCT02665052|EG002|Reported Event|Delayed Entry Usual Care|Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
11263991|NCT02665052|EG003|Reported Event|Home-based BATRAC Caregivers|An identified caregiver provided assistance as needed for the home-based intervention.
11263992|NCT02665260|BG000|Baseline|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
11263993|NCT02665260|BG001|Baseline|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
11263994|NCT02665260|BG002|Baseline|Placebo|Patients treated with placebo without occlusion
11263995|NCT02665260|BG003|Baseline|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
11263996|NCT02665260|BG004|Baseline|Total|Total of all reporting groups
11263997|NCT02665260|FG000|Participant Flow|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
11263998|NCT02665260|FG001|Participant Flow|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
11263999|NCT02665260|FG002|Participant Flow|Placebo With Occlusion|Patients treated with placebo and occlusion
11264000|NCT02665260|FG003|Participant Flow|Placebo Without Occlusion|Patients treated with placebo without conclusion
11264001|NCT02665260|OG000|Outcome|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
11264002|NCT02665260|OG001|Outcome|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
11264003|NCT02665260|OG002|Outcome|Placebo With Occlusion|Patients treated with placebo and occlusion
11264004|NCT02665260|OG003|Outcome|Placebo Without Occlusion|Patients treated with placebo without conclusion
11264005|NCT02665260|OG000|Outcome|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
11264006|NCT02665260|OG001|Outcome|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
11264007|NCT02665260|OG002|Outcome|Placebo|Patients treated with placebo without occlusion
11264008|NCT02665260|OG003|Outcome|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
11264009|NCT02665260|EG000|Reported Event|Cantharidin|Subjects treated with topical cantharidin 0.7% without occlusion
11264010|NCT02665260|EG001|Reported Event|Cantharidin With Occlusion|Subjects treated with topical cantharidin 0.7% with occlusion
11264011|NCT02665260|EG002|Reported Event|Placebo|Subjects treated with placebo without occlusion
11264012|NCT02665260|EG003|Reported Event|Placebo With Occlusion|Subjects treated with placebo with occlusion
11264013|NCT02665273|BG000|Baseline|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique~Greater occipital nerve block: Bilateral greater occipital nerve block"
11264014|NCT02665273|BG001|Baseline|Sham|"Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve~Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally"
11264015|NCT02665273|BG002|Baseline|Total|Total of all reporting groups
11264016|NCT02665273|FG000|Participant Flow|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique~Greater occipital nerve block: Bilateral greater occipital nerve block"
11264017|NCT02665273|FG001|Participant Flow|Sham|"Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve~Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally"
11264018|NCT02665273|OG000|Outcome|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique~Greater occipital nerve block: Bilateral greater occipital nerve block"
11264019|NCT02665273|OG001|Outcome|Sham|"Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve~Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally"
11264020|NCT02665273|EG000|Reported Event|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique~Greater occipital nerve block: Bilateral greater occipital nerve block"
11264021|NCT02665273|EG001|Reported Event|Sham|"Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve~Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally"
11264022|NCT02665286|BG000|Baseline|Placebo|"Naproxen 500mg po BID x 10 days #20 + Placebo~Naproxen: Naproxen 500mg PO BID x 7 days~Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days"
11264023|NCT02665286|BG001|Baseline|Orphenadrine|"Naproxen 500mg po BID x 10 days #20 + Orphenadrine~Orphenadrine: Orphenadrine 100mg PO BID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264024|NCT02665286|BG002|Baseline|Methocarbamol|"Naproxen 500mg po BID x 10 days #20 + Methocarbamol~Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264025|NCT02665286|BG003|Baseline|Total|Total of all reporting groups
11264026|NCT02665286|FG000|Participant Flow|Placebo|"Naproxen 500mg po BID x 10 days #20 + Placebo~Naproxen: Naproxen 500mg PO BID x 7 days~Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days"
11264027|NCT02665286|FG001|Participant Flow|Orphenadrine|"Naproxen 500mg po BID x 10 days #20 + Orphenadrine~Orphenadrine: Orphenadrine 100mg PO BID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264028|NCT02665286|FG002|Participant Flow|Methocarbamol|"Naproxen 500mg po BID x 10 days #20 + Methocarbamol~Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264029|NCT02665286|OG000|Outcome|Placebo|"Naproxen 500mg po BID x 10 days #20 + Placebo~Naproxen: Naproxen 500mg PO BID x 7 days~Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days"
11264030|NCT02665286|OG001|Outcome|Orphenadrine|"Naproxen 500mg po BID x 10 days #20 + Orphenadrine~Orphenadrine: Orphenadrine 100mg PO BID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264031|NCT02665286|OG002|Outcome|Methocarbamol|"Naproxen 500mg po BID x 10 days #20 + Methocarbamol~Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264032|NCT02665286|EG000|Reported Event|Placebo|"Naproxen 500mg po BID x 10 days #20 + Placebo~Naproxen: Naproxen 500mg PO BID x 7 days~Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days"
11264033|NCT02665286|EG001|Reported Event|Orphenadrine|"Naproxen 500mg po BID x 10 days #20 + Orphenadrine~Orphenadrine: Orphenadrine 100mg PO BID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264034|NCT02665286|EG002|Reported Event|Methocarbamol|"Naproxen 500mg po BID x 10 days #20 + Methocarbamol~Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days~Naproxen: Naproxen 500mg PO BID x 7 days"
11264035|NCT02665364|BG000|Baseline|IFN-Kinoid|IFN-K adjuvanted with ISA 51 VG
11264036|NCT02665364|BG001|Baseline|Placebo|Placebo adjuvanted with ISA 51 VG
11264037|NCT02665364|BG002|Baseline|Total|Total of all reporting groups
11264038|NCT02665364|FG000|Participant Flow|IFN-K|Subjects received IFN-K adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
11264039|NCT02665364|FG001|Participant Flow|Placebo|Subjects received placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
11264040|NCT02665364|OG000|Outcome|IFN-K|IFN-K adjuvanted with ISA 51 VG
11264041|NCT02665364|OG001|Outcome|Placebo|Placebo adjuvanted with ISA 51 VG
11264042|NCT02665364|EG000|Reported Event|IFN-K|IFN-K adjuvanted with ISA 51 VG
11264043|NCT02665364|EG001|Reported Event|Placebo|Placebo adjuvanted with ISA 51 VG
11264044|NCT02665455|BG000|Baseline|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11264045|NCT02665455|FG000|Participant Flow|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11264046|NCT02665455|OG000|Outcome|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11264047|NCT02665455|EG000|Reported Event|Intervention|"FreeStyle Libre Flash Glucose Monitoring System~FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
11264048|NCT02665468|BG000|Baseline|Arm 1: Supported Adoption Intervention|"Supported adoption intervention~Supported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)"
11264049|NCT02665468|BG001|Baseline|Arm 2: General Wellness Information|"General wellness information~Active comparator control: The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention"
11264050|NCT02665468|BG002|Baseline|Total|Total of all reporting groups
11264051|NCT02665468|FG000|Participant Flow|Arm 1: Supported Adoption Intervention|"Supported adoption intervention~Supported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)"
11264052|NCT02665468|FG001|Participant Flow|Arm 2: Usual Care|Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.
11264053|NCT02665468|OG000|Outcome|Arm 1: Supported Adoption Intervention|"Supported adoption intervention~Supported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)"
11264054|NCT02665468|OG001|Outcome|Arm 2: Usual Care|Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.
11264055|NCT02665468|EG000|Reported Event|Arm 1: Supported Adoption Intervention|"Supported adoption intervention~Supported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)"
11264056|NCT02665468|EG001|Reported Event|Arm 2: Usual Care|Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.
11264057|NCT02665689|BG000|Baseline|Regular Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264058|NCT02665689|BG001|Baseline|Intensified Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264059|NCT02665689|BG002|Baseline|Total|Total of all reporting groups
11264060|NCT02665689|FG000|Participant Flow|Regular Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264061|NCT02665689|FG001|Participant Flow|Intensified Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
10848140|NCT00288704|FG001|Participant Flow|Rilonacept 160 mg|"If assigned, subjects received rilonacept 160 mg during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). Note: Between weeks 6 and 15 (Parts A and B), all subjects received rilonacept 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg."
11264062|NCT02665689|OG000|Outcome|Regular Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264063|NCT02665689|OG001|Outcome|Intensified Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264064|NCT02665689|EG000|Reported Event|Regular Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264065|NCT02665689|EG001|Reported Event|Intensified Glycemic Control|"Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.~ranibizumab: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied."
11264066|NCT02665728|BG000|Baseline|BLI400|"BLI400 Laxative~BLI400 Laxative"
11264067|NCT02665728|FG000|Participant Flow|BLI400|"BLI400 Laxative~BLI400 Laxative"
11264068|NCT02665728|OG000|Outcome|BLI400|"BLI400 Laxative~BLI400 Laxative"
11264069|NCT02665728|EG000|Reported Event|BLI400|"BLI400 Laxative~BLI400 Laxative"
11264070|NCT02665741|BG000|Baseline|Control|"No distal colonoscope attachment will be used in this arm~Control: No distal colonoscope attachments"
11264071|NCT02665741|BG001|Baseline|Olympus Transparent Cap|"The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure~Olympus transparent cap: distal colonoscope attachment"
11264072|NCT02665741|BG002|Baseline|Medivators Endocuff|"The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure~Medivators Endocuff: distal colonoscope attachment"
11264073|NCT02665741|BG003|Baseline|Total|Total of all reporting groups
11264074|NCT02665741|FG000|Participant Flow|Control|"No distal colonoscope attachment will be used in this arm~Control: No distal colonoscope attachments"
11264075|NCT02665741|FG001|Participant Flow|Olympus Transparent Cap|"The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure~Olympus transparent cap: distal colonoscope attachment"
11264076|NCT02665741|FG002|Participant Flow|Medivators Endocuff|"The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure~Medivators Endocuff: distal colonoscope attachment"
11264077|NCT02665741|OG000|Outcome|Control|"No distal colonoscope attachment will be used in this arm~Control: No distal colonoscope attachments"
11264078|NCT02665741|OG001|Outcome|Olympus Transparent Cap|"The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure~Olympus transparent cap: distal colonoscope attachment"
11264079|NCT02665741|OG002|Outcome|Medivators Endocuff|"The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure~Medivators Endocuff: distal colonoscope attachment"
11264080|NCT02665741|EG000|Reported Event|Control|"Standard colonoscopy - no distal colonoscope attachment will be used in this arm~Control: No distal colonoscope attachments"
11264081|NCT02665741|EG001|Reported Event|Olympus Transparent Cap|"The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure~Olympus transparent cap: distal colonoscope attachment"
11264082|NCT02665741|EG002|Reported Event|Medivators Endocuff|"The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure~Medivators Endocuff: distal colonoscope attachment"
11264083|NCT02665975|BG000|Baseline|Experimental Group: iCBT|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: Tinnitus e-learning programme"
11264084|NCT02665975|BG001|Baseline|Face-to-face Clinical Tinnitus Care|"Receive individual face-to-face tinnitus care, and follow-up appointments as required.~Face-to-face clinical tinnitus care: Hospital tinnitus counselling"
11264085|NCT02665975|BG002|Baseline|Total|Total of all reporting groups
11337497|NCT03586544|BG001|Baseline|Interval Warm up First|"Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and~Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, interval warm-up visit was completed first."
11337498|NCT03586544|BG002|Baseline|Total|Total of all reporting groups
11337499|NCT03586544|FG000|Participant Flow|Order 1: Albuterol First, Interval Warm-up Second|Participants first received albuterol on one day only. After at least 72 h, they completed the interval warm up on one day only. This was an acute study. There is no washout per se.
11337500|NCT03586544|FG001|Participant Flow|Order 2: Interval Warm-up First, Albuterol Second|Participants first completed interval warm up exercise on one day only. After at least 72 h, they recieved the albuterol (180ug) on one day only. This was an acute study. There is no washout per se.
11337501|NCT03586544|OG000|Outcome|Albuterol First|Albuterol first and then interval warm up
11337502|NCT03586544|OG001|Outcome|Interval Warm-up First|Interval warm-up first and then albuterol
11337503|NCT03586544|EG000|Reported Event|Albuterol Intervention|180 ug of albuterol given on one day in this acute study.
11337504|NCT03586544|EG001|Reported Event|Interval Warm-up Intervention|Interval warm-up exercise completed on one day in this acute study.
11337505|NCT03586583|BG000|Baseline|FBP (Old Processing)/ISR (New Processing)|Filtered back projection (old processing) and ISR (new processing) images of the same breast are presented side-by-side for radiologist review.
11337506|NCT03586583|FG000|Participant Flow|FBP (Old Processing) and ISR (New Processing)|Radiologists reviewed images of a breast with ISR side-by-side the same breast with FBP. They were blinded to the image reconstruction and presentation processing methods. Radiologists compared several general mammographic features and were asked to grade each feature on each view using the 5-point Likert scale outlined previously.
11337507|NCT03586583|OG000|Outcome|ISR (New Processing)|"Iterative super resolution; new processing.~ISR: New processing"
11337508|NCT03586583|EG000|Reported Event|FBP (Old Processing)|This was a reader study where radiologists/readers compared processing of previously acquired images.
11337509|NCT03586583|EG001|Reported Event|ISR (New Processing)|This was a reader study where radiologists/readers compared processing of previously acquired images.
11337510|NCT03586648|BG000|Baseline|Dispensed Subjects|All subjects dispensed at least one study lens.
11337511|NCT03586648|FG000|Participant Flow|Test/Control|Subjects that were randomized to receive the Test lens in both eyes during the first period and the Control lens in both eyes during the second period.
11337512|NCT03586648|FG001|Participant Flow|Control/Test|Subjects that were randomized to receive the Control lens in both eyes during the first period and the Test lens in both eyes during the second period.
11337513|NCT03586648|OG000|Outcome|Test|Subjects that wore the Test lens in the study.
11337514|NCT03586648|OG001|Outcome|Control|Subjects that wore the Control lens in the study.
11337515|NCT03586648|EG000|Reported Event|Test|Subjects that wore the Test lens during either period of the study.
11337516|NCT03586648|EG001|Reported Event|Control|Subjects that wore the Control lens during either period of the study.
11264086|NCT02665975|FG000|Participant Flow|Experimental Group: iCBT|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: Tinnitus e-learning programme"
11264087|NCT02665975|FG001|Participant Flow|Face-to-face Clinical Tinnitus Care|"Receive individual face-to-face tinnitus care, and follow-up appointments as required.~Face-to-face clinical tinnitus care: Hospital tinnitus counselling"
11264088|NCT02665975|OG000|Outcome|Experimental Group: iCBT|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: Tinnitus e-learning programme"
11264089|NCT02665975|OG001|Outcome|Face-to-face Clinical Tinnitus Care|"Receive individual face-to-face tinnitus care, and follow-up appointments as required.~Face-to-face clinical tinnitus care: Hospital tinnitus counselling"
11264090|NCT02665975|EG000|Reported Event|Experimental Group: iCBT|"CBT-based internet-intervention for tinnitus The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.~CBT-based internet-intervention for tinnitus: Tinnitus e-learning programme"
11264091|NCT02665975|EG001|Reported Event|Face-to-face Clinical Tinnitus Care|"Receive individual face-to-face tinnitus care, and follow-up appointments as required.~Face-to-face clinical tinnitus care: Hospital tinnitus counselling"
11264092|NCT02666222|BG000|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11264093|NCT02666222|FG000|Participant Flow|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11264094|NCT02666222|OG000|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11264095|NCT02666222|EG000|Reported Event|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
11264096|NCT02666352|BG000|Baseline|Moderate HI Participants|Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264097|NCT02666352|BG001|Baseline|Severe HI Participants|Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264098|NCT02666352|BG002|Baseline|Healthy Participants|Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264099|NCT02666352|BG003|Baseline|Total|Total of all reporting groups
11264100|NCT02666352|FG000|Participant Flow|Moderate HI Participants|Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264101|NCT02666352|FG001|Participant Flow|Severe HI Participants|Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264102|NCT02666352|FG002|Participant Flow|Healthy Participants|Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264103|NCT02666352|OG000|Outcome|Moderate HI Participants|Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264104|NCT02666352|OG001|Outcome|Severe HI Participants|Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264105|NCT02666352|OG002|Outcome|Healthy Participants|Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264106|NCT02666352|EG000|Reported Event|Moderate HI Participants|Participants with moderate HI (Child-Pugh score 7 to 9) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264107|NCT02666352|EG001|Reported Event|Severe HI Participants|Participants with severe HI (Child-Pugh score 10 to 15) received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264108|NCT02666352|EG002|Reported Event|Healthy Participants|Participants with normal hepatic function received a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
11264109|NCT02666508|BG000|Baseline|Plaque Identifying Toothpaste|"A 30 day supply of dosed syringes containing a plaque identifying toothpaste~Plaque identifying toothpaste: Plaque identifying toothpaste~Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening."
11264110|NCT02666508|BG001|Baseline|Non-plaque Identifying Toothpaste|"A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste~Non-plaque identifying toothpaste: Non-plaque identifying toothpaste~Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening."
11264111|NCT02666508|BG002|Baseline|Total|Total of all reporting groups
11264112|NCT02666508|FG000|Participant Flow|Plaque Identifying Toothpaste|A 30 day supply of dosed syringes containing a plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.
11264113|NCT02666508|FG001|Participant Flow|Non-plaque Identifying Toothpaste|A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.
11264114|NCT02666508|OG000|Outcome|Plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol~Plaque identifying toothpaste: Plaque identifying toothpaste with targetol"
11264115|NCT02666508|OG001|Outcome|Non-plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol~Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol"
11264116|NCT02666508|OG000|Outcome|Plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol~Plaque identifying toothpaste: Plaque identifying toothpaste with targetol~With follow-up between 30-60 days."
11264117|NCT02666508|OG001|Outcome|Non-plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol~Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol~With follow-up between 30-60 days."
11264118|NCT02666508|OG000|Outcome|Plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol~Plaque identifying toothpaste: Plaque identifying toothpaste with targetol~With baseline hs-CRP between 0.5 and 10 mg/L and follow-up between 30-60 days."
11264119|NCT02666508|OG001|Outcome|Non-plaque Identifying Toothpaste|"A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol~Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol~With baseline hs-CRP between 0.5 and 10 mg/L and follow-up between 30-60 days."
11264120|NCT02666508|EG000|Reported Event|Plaque Identifying Toothpaste|"A 30 day supply of dosed syringes containing a plaque identifying toothpaste~Plaque identifying toothpaste: Plaque identifying toothpaste"
11264121|NCT02666508|EG001|Reported Event|Non-plaque Identifying Toothpaste|"A 30 day supply of dosed syringes containing an identical non plaque identifying toothpaste~Non-plaque identifying toothpaste: Non-plaque identifying toothpaste"
11264122|NCT02666560|BG000|Baseline|All Study Participants|"Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.~Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.~This was a crossover design where participants completed both arms in the trial."
11264123|NCT02666560|FG000|Participant Flow|Cueing Self Paced Then Cueing 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.~Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."
11264124|NCT02666560|FG001|Participant Flow|Cueing at 20% Above Self Paced Cadence Then Self Based Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."
11264125|NCT02666560|OG000|Outcome|ACSC|Auditory cueing at self paced cadence
11264126|NCT02666560|OG001|Outcome|AC20|Auditory cueing set at 20% above self paced cadence
11264127|NCT02666560|OG001|Outcome|AC20|Auditory cueing at 20% above self paced cadence
11264128|NCT02666560|EG000|Reported Event|Auditory Cueing at Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: Auditory cueing set at different frequency rates"
11264129|NCT02666560|EG001|Reported Event|Cueing at 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.~Auditory Cueing: Auditory cueing set at different frequency rates"
11264130|NCT02666664|BG000|Baseline|Placebo|During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264131|NCT02666664|BG001|Baseline|Bempedoic Acid|During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264132|NCT02666664|BG002|Baseline|Total|Total of all reporting groups
11264133|NCT02666664|FG000|Participant Flow|Placebo|During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264134|NCT02666664|FG001|Participant Flow|Bempedoic Acid|During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264135|NCT02666664|OG000|Outcome|Placebo|During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264136|NCT02666664|OG001|Outcome|Bempedoic Acid|During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264137|NCT02666664|EG000|Reported Event|Bempedoic Acid|During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11264138|NCT02666664|EG001|Reported Event|Placebo|During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
11337517|NCT03586726|BG000|Baseline|Balovaptan + Rifampicin|Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
11264139|NCT02666742|BG000|Baseline|DOAC|"Participants will be asked to take approved dose of the drug for stroke Px~DOAC Apixaban is a blood thinning drug, also called an anticoagulant. DOAC is approved by the U.S. Food and Drug Administration (FDA) for stroke prophylaxis and the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs."
11264140|NCT02666742|BG001|Baseline|Aspirin|"Participants will be asked to take 81 milligrams by mouth once per day.~Aspirin: Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation."
11264141|NCT02666742|BG002|Baseline|Total|Total of all reporting groups
11264142|NCT02666742|FG000|Participant Flow|Direct Oral Anticoagulant (DOAC)|"Participants will be asked to take a DOAC (Rivaroxaban/Apixiban/Dabigatran/Edoxaban) dose that is approved for stroke prophylaxis for 30 days post ablation~DOAC: DOAC is a blood thinning drug, also called an anticoagulant. DOAC is approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis of stroke in atrial fibrillation patients and treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs."
11264143|NCT02666742|FG001|Participant Flow|Aspirin|"Participants will be asked to take 81 milligrams by mouth once per day.~Aspirin: Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation."
11264144|NCT02666742|OG000|Outcome|DOAC|DOAC is a blood thinner group
11264145|NCT02666742|OG001|Outcome|Aspirin|"Participants will be asked to take 81 milligrams by mouth once per day.~Aspirin: Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation."
11264146|NCT02666742|OG000|Outcome|DOAC|"Participants will be asked to take standard dose approved for stroke prophylaxis~DOAC: DOAC is a blood thinning drug, also called direct oral anticoagulant. These group of drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of stroke prophylaxis in atrial fibrillation and deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs."
11264147|NCT02666742|OG000|Outcome|DOAC|"Participants will be asked to take DOAC as prescribed~DOAC is a blood thinning drug, also called an anticoagulant. DOACs are approved by the U.S. Food and Drug Administration (FDA) for stroke prophylaxis and the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs."
11264148|NCT02666742|EG000|Reported Event|Apixaban|"Participants will be asked to take 5 milligrams by mouth twice per day.~Apixaban: Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is approved by the U.S. Food and Drug Administration (FDA) for the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs."
11264149|NCT02666742|EG001|Reported Event|Aspirin|"Participants will be asked to take 81 milligrams by mouth once per day.~Aspirin: Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation."
11264150|NCT02666846|BG000|Baseline|Cohort 1|"Cohort 1:~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel) or Ibuprofen, Nurofen oral tablets (2 x 400 mg)"
11264151|NCT02666846|BG001|Baseline|Cohort 2:|"Cohort 2:~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264152|NCT02666846|BG002|Baseline|Cohort 3|"Cohort 3:~Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264153|NCT02666846|BG003|Baseline|Total|Total of all reporting groups
11264154|NCT02666846|FG000|Participant Flow|Cohort 1 (Dosed on Days 1, 2 and 3)|"All Cohort 1 participants: Ibuprofen (day 1), TIB200 gel (10%, w/w) (Day 2) and TIB200 (placebo gel) (Day 3)~(Follow up 7-9 days post last UVB irradiation)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264155|NCT02666846|FG001|Participant Flow|Cohort 2 (Dosed on Days 1,2,3 and 4)|"All Cohort 2 Participants: Diclofenac, DCF100 gel (2% w/w) (day 1), DCF100 gel (4% w/w) (day 2), DCF100 gel (marching placebo) Day 3 and Voltarol® 12 Hour Emulgel® P 2.32% Gel (day 4)~(Follow up 7-9 days post last UVB irradiation)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264156|NCT02666846|FG002|Participant Flow|Cohort 3 (Dosed on Days 1 and 2)|"All Cohort 3 Participants: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol) (day 1) and SPR300 (Matching Placebo) (day 2)~Follow up visit between days 7-9 post last UVB irradiation~Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264157|NCT02666846|OG000|Outcome|Cohort 1: TIB200 Gel 10%|"Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11337518|NCT03586726|FG000|Participant Flow|Balovaptan + Rifampicin|Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
11264158|NCT02666846|OG001|Outcome|Cohort 1: Nurofen Gel 10%|"Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264159|NCT02666846|OG002|Outcome|Cohort 1: Nurofen Tablets|"Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264160|NCT02666846|OG003|Outcome|Cohort 1: TIB200 Placebo Gel|"Cohort 1: TIB200 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264161|NCT02666846|OG004|Outcome|Cohort 2: DCF100 Gel 2%|"Cohort 2: Diclofenac, DCF100 gel (2% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264162|NCT02666846|OG005|Outcome|Cohort 2: DCF100 Gel 4%|"Cohort 2: Diclofenac, DCF100 gel (4% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264163|NCT02666846|OG006|Outcome|Cohort 2: Voltaren Gel 2%|"Cohort 2: Diclofenac, Voltaren Emulgel (2%)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264164|NCT02666846|OG007|Outcome|Cohort 2: Voltarol Oral Tablet|"Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264165|NCT02666846|OG008|Outcome|Cohort 2: DCF100 Placebo Gel|"Cohort 2: DCF100 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264166|NCT02666846|OG009|Outcome|Cohort 3: SPR300 Gel (15%:7%)|"Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)~Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264167|NCT02666846|OG010|Outcome|Cohort 3: SPR300 Placebo Gel|"Cohort 3: SPR300 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264168|NCT02666846|OG003|Outcome|Cohort 2: DCF100 Gel 2%|"Cohort 2: Diclofenac, DCF100 gel (2% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264169|NCT02666846|OG004|Outcome|Cohort 2: DCF100 Gel 4%|"Cohort 2: Diclofenac, DCF100 gel (4% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264170|NCT02666846|OG005|Outcome|Cohort 2: Voltaren Gel 2%|"Cohort 2: Diclofenac, Voltaren Emulgel (2%)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264171|NCT02666846|OG006|Outcome|Cohort 2: Voltarol Oral Tablet|"Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264172|NCT02666846|OG007|Outcome|Cohort 3: SPR300 Gel (15%:7%)|"Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)~Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11337519|NCT03586726|OG000|Outcome|Balovaptan + Rifampicin|Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
11264173|NCT02666846|OG008|Outcome|Cohort 3: SPR300 Placebo Gel|"Cohort 3: SPR300 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264174|NCT02666846|EG000|Reported Event|Cohort 1: TIB200 Gel 10%|"Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264175|NCT02666846|EG001|Reported Event|Cohort 1: Nurofen Gel 10%|"Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264176|NCT02666846|EG002|Reported Event|Cohort 1: Nurofen Tablets|"Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)~Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel)."
11264177|NCT02666846|EG003|Reported Event|Cohort 1: TIB200 Placebo Gel|"Cohort 1: TIB200 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264178|NCT02666846|EG004|Reported Event|Cohort 2: DCF100 Gel 2%|"Cohort 2: Diclofenac, DCF100 gel (2% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264179|NCT02666846|EG005|Reported Event|Cohort 2: DCF100 Gel 4%|"Cohort 2: Diclofenac, DCF100 gel (4% w/w)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264180|NCT02666846|EG006|Reported Event|Cohort 2: Voltaren Gel 2%|"Cohort 2: Diclofenac, Voltaren Emulgel (2%)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264181|NCT02666846|EG007|Reported Event|Cohort 2: Voltarol Oral Tablet|"Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)~Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264182|NCT02666846|EG008|Reported Event|Cohort 2: DCF100 Placebo Gel|"Cohort 2: DCF100 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264183|NCT02666846|EG009|Reported Event|Cohort 3: SPR300 Gel (15%:7%)|"Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)~Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264184|NCT02666846|EG010|Reported Event|Cohort 3: SPR300 Placebo Gel|"Cohort 3: SPR300 matching placebo gel~Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing."
11264185|NCT02666950|BG000|Baseline|Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)|Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.
11264186|NCT02666950|FG000|Participant Flow|Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)|Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.
11264187|NCT02666950|OG000|Outcome|Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)|Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.
11264188|NCT02666950|EG000|Reported Event|Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)|Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.
11264189|NCT02667236|BG000|Baseline|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11264190|NCT02667236|BG001|Baseline|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11264191|NCT02667236|BG002|Baseline|Total|Total of all reporting groups
11264192|NCT02667236|FG000|Participant Flow|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11264193|NCT02667236|FG001|Participant Flow|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11264194|NCT02667236|OG000|Outcome|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11264195|NCT02667236|OG001|Outcome|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11264196|NCT02667236|EG000|Reported Event|A-101 Solution|"A-101 Solution 40% applied topically~A-101 Solution: Active Drug"
11264197|NCT02667236|EG001|Reported Event|Vehicle Solution|"Vehicle Solution applied topically~Vehicle Solution: Placebo"
11264198|NCT02667275|BG000|Baseline|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11264199|NCT02667275|BG001|Baseline|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11264200|NCT02667275|BG002|Baseline|Total|Total of all reporting groups
11264201|NCT02667275|FG000|Participant Flow|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11264202|NCT02667275|FG001|Participant Flow|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11264203|NCT02667275|OG000|Outcome|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11264204|NCT02667275|OG001|Outcome|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11264205|NCT02667275|EG000|Reported Event|A-101 Solution|"A-101 Solution 40% administered once~A-101 Solution"
11264206|NCT02667275|EG001|Reported Event|Vehicle Solution|"Vehicle Solution administered once~Vehicle Solution: Placebo"
11264207|NCT02667288|BG000|Baseline|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
10970012|NCT00908466|FG001|Participant Flow|Subconjunctival Injection|"Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120."
11264208|NCT02667288|FG000|Participant Flow|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11264209|NCT02667288|OG000|Outcome|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11264210|NCT02667288|EG000|Reported Event|A-101 Solution|"A-101 Solution 40% administered topically for a maximum of 4 treatment visits~A-101 Solution"
11264211|NCT02667301|BG000|Baseline|EMG, TAS and Tympanometry|"All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:~The patient is subjected to tympanometry test on the specific ear,~The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded,~The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test.~Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded."
11264212|NCT02667301|FG000|Participant Flow|EMG, TAS and Tympanometry|"All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:~The patient is subjected to tympanometry test on the specific ear,~The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded,~The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test.~Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded."
11264213|NCT02667301|OG000|Outcome|EMG, TAS and Tympanometry|"All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:~The patient is subjected to tympanometry test on the specific ear,~The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded,~The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test.~Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded."
11264214|NCT02667301|OG000|Outcome|mLVP|Recorded amplitude of mLVP
11264215|NCT02667301|OG001|Outcome|mTVP|Recorded amplitude of mTVP
11264216|NCT02667301|EG000|Reported Event|EMG, TAS and Tympanometry|"All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:~The patient is subjected to tympanometry test on the specific ear,~The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded,~The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test.~Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded."
11286726|NCT02891915|BG001|Baseline|Standard Course|"Participants will receive a standard course of the initially prescribed antibiotic( Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body."
11286727|NCT02891915|BG002|Baseline|Total|Total of all reporting groups
11337520|NCT03586726|EG000|Reported Event|BALOVAPTAN+RIFAMPICIN|"In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.~In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.~In Period 2, 600 mg of rifampicin was administered alone as a qd dose on Days 7 to 16."
11264217|NCT02667392|BG000|Baseline|Biofeedback Group|"Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.~Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.~Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they push off with their (paretic) leg to swing it forward when the participant-specific pre-programmed threshold is exceeded."
11264218|NCT02667392|FG000|Participant Flow|Biofeedback Group|"Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.~Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.~Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they push off with their (paretic) leg to swing it forward when the participant-specific pre-programmed threshold is exceeded."
11264219|NCT02667392|OG000|Outcome|Biofeedback Group|"Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.~Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.~Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they push off with their (paretic) leg to swing it forward when the participant-specific pre-programmed threshold is exceeded."
11264220|NCT02667392|EG000|Reported Event|Biofeedback Group|"Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.~Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.~Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they push off with their (paretic) leg to swing it forward when the participant-specific pre-programmed threshold is exceeded."
11264221|NCT02667457|BG000|Baseline|CAD Participants|Participants with asymptomatic or previously symptomatic with TIA only carotid atherosclerotic plaque with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11264222|NCT02667457|BG001|Baseline|Healthy Participants|Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11264223|NCT02667457|BG002|Baseline|Total|Total of all reporting groups
11264224|NCT02667457|FG000|Participant Flow|Carotid Atherosclerotic Plaque (CAD) Participants|Participants with asymptomatic or previously symptomatic with TIA only carotid atherosclerotic plaque with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an intraveneous (IV) catheter in an antecubital vein, followed by a saline flush on Day 0.
11264225|NCT02667457|FG001|Participant Flow|Healthy Participants|Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11264226|NCT02667457|OG000|Outcome|CAD Participants|Participants with asymptomatic or previously symptomatic with TIA only carotid atherosclerotic plaque with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11337521|NCT03586830|BG000|Baseline|Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11337522|NCT03586830|BG001|Baseline|JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264227|NCT02667457|OG001|Outcome|Healthy Participants|Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11264228|NCT02667457|OG000|Outcome|CAD Participants|Participants with asymptomatic carotid atherosclerotic plaque or previously symptomatic with TIA only with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on Day 0.
11264229|NCT02667457|EG000|Reported Event|CAD Participants|Participants with asymptomatic carotid atherosclerotic plaque or previously symptomatic with TIA only with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on screening (Day 0).
11264230|NCT02667457|EG001|Reported Event|Healthy Participants|Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on screening (Day 0).
11264231|NCT02667626|BG000|Baseline|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts."
11264232|NCT02667626|BG001|Baseline|Control|"Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.~Control: Web-based resource lists and text-based study adherence reminders"
11264233|NCT02667626|BG002|Baseline|Total|Total of all reporting groups
11264234|NCT02667626|FG000|Participant Flow|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence"
11264235|NCT02667626|FG001|Participant Flow|Control|"Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.~Control: Web-based resource lists and text-based study adherence reminders"
11264236|NCT02667626|OG000|Outcome|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence"
11264237|NCT02667626|OG001|Outcome|Control|"Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.~Control: Web-based resource lists and text-based study adherence reminders"
11264238|NCT02667626|OG000|Outcome|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts."
11264239|NCT02667626|OG000|Outcome|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of websites, followed by reproductive health prompts and study adherence reminders for 24 weeks.~Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts."
11264240|NCT02667626|OG001|Outcome|Control|"Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.~Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.~Control: Web-based resource lists and text-based study adherence reminders"
11337523|NCT03586830|BG002|Baseline|JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264241|NCT02667626|EG000|Reported Event|SCPR Intervention|"Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.~Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts."
11264242|NCT02667626|EG001|Reported Event|Control|"Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.~Control: Web-based resource lists and text-based study adherence reminders"
11264243|NCT02667704|BG000|Baseline|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
11264244|NCT02667704|FG000|Participant Flow|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
11264245|NCT02667704|OG000|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
11264246|NCT02667704|OG001|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11264247|NCT02667704|EG000|Reported Event|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 administered orally with 240 millilitre (mL) of water.
11264248|NCT02667704|EG001|Reported Event|Bosentan|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 6 of period 2 administered orally with 240 mL of water
11264249|NCT02667704|EG002|Reported Event|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 7 and 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
11264250|NCT02667821|BG000|Baseline|Intervention Group|Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11264251|NCT02667821|FG000|Participant Flow|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11264252|NCT02667821|OG000|Outcome|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11264253|NCT02667821|OG000|Outcome|Intervention Group|"Participants included in the experimental arm will be adults aged 18 years and older with chronic neck pain who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. Each participant will begin with neutral cervical spine as a standard natural control, followed by block randomization between maximum voluntary rotation of the cervical spine and one cervical manipulation. Please see Intervention section for a detailed description.~Head positions and spinal manipulation: Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held fo"
11286728|NCT02891915|FG000|Participant Flow|Short Course|"Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.~Placebo: Placebo"
11264254|NCT02667821|EG000|Reported Event|Intervention Group|Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Head positions and spinal manipulation: Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
11264255|NCT02667912|BG000|Baseline|Distal Renal Denervation|Endovascular denervation of segmental branches of renal artery
11264256|NCT02667912|BG001|Baseline|Conventional Renal Denervation|Endovascular denervation of main trunk of renal artery
11264257|NCT02667912|BG002|Baseline|Total|Total of all reporting groups
11264258|NCT02667912|FG000|Participant Flow|Distal Renal Denervation|Endovascular denervation of segmental branches of renal artery
11264259|NCT02667912|FG001|Participant Flow|Conventional Renal Denervation|Endovascular denervation of main trunk of renal artery
11264260|NCT02667912|OG000|Outcome|Distal Renal Denervation|Endovascular denervation of segmental branches of renal artery
11264261|NCT02667912|OG001|Outcome|Conventional Renal Denervation|Endovascular denervation of main trunk of renal artery
11264262|NCT02667912|EG000|Reported Event|Distal Renal Denervation|Endovascular denervation of segmental branches of renal artery
11264263|NCT02667912|EG001|Reported Event|Conventional Renal Denervation|Endovascular denervation of main trunk of renal artery
11264264|NCT02667951|BG000|Baseline|Control Group|Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.
11264265|NCT02667951|BG001|Baseline|Intervention Group|"Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.~A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated."
11264266|NCT02667951|BG002|Baseline|Total|Total of all reporting groups
11264267|NCT02667951|FG000|Participant Flow|Control Group|Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.
11264268|NCT02667951|FG001|Participant Flow|Intervention Group|"Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.~A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated."
11264269|NCT02667951|OG000|Outcome|Control Group|Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.
11264270|NCT02667951|OG001|Outcome|Intervention Group|"Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.~A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated."
11264271|NCT02667951|EG000|Reported Event|Control Group|Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.
11264272|NCT02667951|EG001|Reported Event|Intervention Group|"Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.~A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated."
11264273|NCT02668003|BG000|Baseline|Cognitive Behavioural Therapy|"Brief Cognitive Behavioural Therapy delivered by telephone~Cognitive Behavioural Therapy: The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan."
11264274|NCT02668003|BG001|Baseline|Treatment as Usual|The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions.
11264275|NCT02668003|BG002|Baseline|Total|Total of all reporting groups
11264276|NCT02668003|FG000|Participant Flow|Cognitive Behavioural Therapy|"Brief Cognitive Behavioural Therapy delivered by telephone~Cognitive Behavioural Therapy: The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan."
11264277|NCT02668003|FG001|Participant Flow|Treatment as Usual|The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions.
11264278|NCT02668003|OG000|Outcome|Cognitive Behavioural Therapy|"Brief Cognitive Behavioural Therapy delivered by telephone~Cognitive Behavioural Therapy: The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan."
11264279|NCT02668003|OG001|Outcome|Treatment as Usual|The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions.
11264280|NCT02668003|EG000|Reported Event|Cognitive Behavioural Therapy|"Brief Cognitive Behavioural Therapy delivered by telephone~Cognitive Behavioural Therapy: The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan."
11264281|NCT02668003|EG001|Reported Event|Treatment as Usual|The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions.
11264282|NCT02668185|BG000|Baseline|Overall Participants|Crossover study - all participants
11264283|NCT02668185|FG000|Participant Flow|Active Drug First Then Placebo|2 week baseline period First NK3R antagonist - AZD4901 - 40mg orally bd - for 4 weeks intervention then 2 weeks washout period then second intervention with Matched placebo orally bd for 4 weeks with 2 weeks monitoring period
11264284|NCT02668185|FG001|Participant Flow|Placebo First Then Active Drug|2 week baseline period First intervention is Placebo - 40mg bd - for 4 weeks, then 2 weeks washout period, then second intervention with NK3R antagonist - AZD4901 - 40mg orally bd - for 4 weeks with 2 weeks monitoring period
11264285|NCT02668185|OG000|Outcome|Active Drug|"NK3R antagonist - AZD4901 - 40mg bd - for 4 weeks~NK3R antagonist - AZD4901: Neurokinin 3 receptor antagonist"
11264286|NCT02668185|OG001|Outcome|Placebo|"Placebo - 40mg bd - for 4 weeks~Placebo: Placebo"
11264287|NCT02668185|EG000|Reported Event|Active Drug First Then Placebo|2 week baseline period First NK3R antagonist - AZD4901 - 40mg orally bd - for 4 weeks intervention then 2 weeks washout period then second intervention with Matched placebo orally bd for 4 weeks with 2 weeks monitoring period
11264288|NCT02668185|EG001|Reported Event|Placebo First Then Active Drug|2 week baseline period First intervention is Placebo - 40mg bd - for 4 weeks, then 2 weeks washout period, then second intervention with NK3R antagonist - AZD4901 - 40mg orally bd - for 4 weeks with 2 weeks monitoring period
11264289|NCT02668198|BG000|Baseline|Endoscopic Scar Assessment|"Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus.~Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique~Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site.~Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR.~Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site.~Biopsy: Endoscopic colorectal mucosal resection"
11337524|NCT03586830|BG003|Baseline|JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11337525|NCT03586830|BG004|Baseline|Total|Total of all reporting groups
11337526|NCT03586830|FG000|Participant Flow|Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
10970013|NCT00908466|OG000|Outcome|Intravitreal Injection|"Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120."
11264290|NCT02668198|FG000|Participant Flow|Endoscopic Scar Assessment|"Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus.~Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique~Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior endoscopic mucosal resection (EMR) site.~Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR.~Olympus CF190 Colonoscope Narrow band imaging (NBI) with near focus: NBI with near focus to help closely examine the area of prior EMR site.~Biopsy: Endoscopic colorectal mucosal resection"
11264291|NCT02668198|OG000|Outcome|Endoscopic Scar Assessment|"Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus.~Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique~Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site.~Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR.~Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site.~Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment"
11264292|NCT02668198|OG000|Outcome|Endoscopic Scar Assessment|"Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus.~Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique~Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior endoscopic mucosal resection (EMR) site.~Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR.~Olympus CF190 Colonoscope Narrow band imaging (NBI) with near focus: NBI with near focus to help closely examine the area of prior EMR site.~Biopsy: Endoscopic colorectal mucosal resection"
11264293|NCT02668198|EG000|Reported Event|Endoscopic Scar Assessment|"Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus.~Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique~Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site.~Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR.~Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site.~Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment"
11264294|NCT02668302|BG000|Baseline|Treatment|Steroid-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
11264295|NCT02668302|BG001|Baseline|Control|Post-op standard of care (i.e. debridement, irrigation, and topical steroids)
11264296|NCT02668302|BG002|Baseline|Total|Total of all reporting groups
11264297|NCT02668302|FG000|Participant Flow|Sinus Implant+Post-op Standard of Care|Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids
11264298|NCT02668302|FG001|Participant Flow|Post-op Standard of Care|Post-op standard of care, including debridement, irrigation, and topical steroids
11264299|NCT02668302|OG000|Outcome|Sinus Implant+Post-op Standard of Care|Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids
11264300|NCT02668302|OG001|Outcome|Post-op Standard of Care|Post-op standard of care, including debridement, irrigation, and topical steroids
11264301|NCT02668302|EG000|Reported Event|Treatment|Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
11264302|NCT02668302|EG001|Reported Event|Control|Post-op standard of care, including debridement, irrigation, and topical steroids
10970014|NCT00908466|OG001|Outcome|Subconjunctival Injection|"Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120."
11264303|NCT02668393|BG000|Baseline|150 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed.
11264304|NCT02668393|BG001|Baseline|200 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day.
11264305|NCT02668393|BG002|Baseline|Total|Total of all reporting groups
11264306|NCT02668393|FG000|Participant Flow|150 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed.
11337527|NCT03586830|FG001|Participant Flow|JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264307|NCT02668393|FG001|Participant Flow|200 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day.
11264308|NCT02668393|OG000|Outcome|Nintedanib + Docetaxel|Comprises all dose cohorts during the dose escalation phase. In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was taken orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression.
11264309|NCT02668393|OG000|Outcome|150 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed.
11264310|NCT02668393|OG001|Outcome|200 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day.
11264311|NCT02668393|EG000|Reported Event|150 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed.
11264312|NCT02668393|EG001|Reported Event|200 mg Nintedanib + Docetaxel|In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day.
11264313|NCT02668432|BG000|Baseline|Partial Load|"150 mg intravenous (IV) bolus dose of amiodarone, followed by continuous infusion of 1 mg/min for 6 hours, with recommended reduction to 0.5 mg/min. Conversion from IV to oral (PO) amiodarone will occur based on patient hemodynamic stability and physician/pharmacist discretion. Patients randomized to the partial load arm will receive <4g IV or < 8g PO. The assigned total loading dose will include all IV and PO amiodarone administered within 7 days from initiation of amiodarone. All doses will be compared in total PO amount (accounting for 50% bioavailability of PO versus IV amiodarone).~Amiodarone: Patients will receive a 150 mg IV bolus amiodarone dose, followed by a 1 mg/min continuous infusion for six hours, then 0.5 mg/min. Conversion to PO amiodarone will be based on patient hemodynamic stability and physician/pharmacist discretion. The total loading dose will be calculated based on all IV and PO amiodarone"
11264314|NCT02668432|BG001|Baseline|Full Load|"All patients will receive a 150 mg intravenous (IV) bolus dose of amiodarone, followed immediately by a continuous infusion of 1 mg/min for the first six hours, with a recommended reduction to 0.5 mg/min subsequently. Conversion from IV to oral (PO) amiodarone will occur based on patient hemodynamic stability and physician/pharmacist discretion. Patients randomized to the partial load arm will receive (≥ 5g IV or ≥10g PO +/- 20%). The assigned total loading dose will include all IV and PO amiodarone administered within 7 days from initiation of amiodarone. All doses will be compared in total PO amount (accounting for 50% bioavailability of PO versus IV amiodarone).~Amiodarone: Patients will receive a 150 mg IV bolus amiodarone dose, followed by a 1 mg/min continuous infusion for six hours, then 0.5 mg/min. Conversion to PO amiodarone will be based on patient hemodynamic stability and physician/pharmacist discretion. The total loading dose will be calculated based on all IV and PO"
11264315|NCT02668432|BG002|Baseline|Total|Total of all reporting groups
11264316|NCT02668432|FG000|Participant Flow|Partial Load|"150 mg intravenous (IV) bolus dose of amiodarone, followed immediately by continuous infusion 1 mg/min for 6 hours, with a reduction to 0.5 mg/min subsequently. Conversion from IV to oral (PO) amiodarone will occur based on patient hemodynamic stability and physician/pharmacist discretion. Patients will receive <4g IV or < 8g PO. The assigned total loading dose will include all IV and PO amiodarone administered within 7 days from initiation of amiodarone. All doses will be compared in total PO amount (accounting for 50% bioavailability of PO versus IV amiodarone).~Amiodarone: Patients will receive a 150 mg IV bolus amiodarone dose, followed by a 1 mg/min continuous infusion for six hours, then 0.5 mg/min. Conversion to PO amiodarone will be based on patient hemodynamic stability and physician/pharmacist discretion. The total loading dose will be calculated based on all IV and PO amiodarone"
11286729|NCT02891915|FG001|Participant Flow|Standard Course|"Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body."
11264317|NCT02668432|FG001|Participant Flow|Full Load|"All patients will receive a 150 mg intravenous (IV) bolus dose of amiodarone, followed immediately by a continuous infusion of 1 mg/min for the first six hours, with a recommended reduction to 0.5 mg/min subsequently. Conversion from IV to oral (PO) amiodarone will occur based on patient hemodynamic stability and physician/pharmacist discretion. Patients randomized to the partial load arm will receive (≥ 5g IV or ≥10g PO +/- 20%). The assigned total loading dose will include all IV and PO amiodarone administered within 7 days from initiation of amiodarone. All doses will be compared in total PO amount (accounting for 50% bioavailability of PO versus IV amiodarone).~Amiodarone: Patients will receive a 150 mg IV bolus amiodarone dose, followed by a 1 mg/min continuous infusion for six hours, then 0.5 mg/min. Conversion to PO amiodarone will be based on patient hemodynamic stability and physician/pharmacist discretion. The total loading dose will be calculated based on all IV and PO"
11264318|NCT02668432|OG000|Outcome|Partial Load|< 10g oral loading dose of amiodarone
11264319|NCT02668432|OG001|Outcome|Full Load|10 g (+/- 20%) oral loading dose of amiodarone
11264320|NCT02668432|EG000|Reported Event|Partial Load|< 10g oral loading dose of amiodarone
11264321|NCT02668432|EG001|Reported Event|Full Load|10 g (+/- 20%) oral loading dose of amiodarone
11264322|NCT02668640|BG000|Baseline|Participants With RA Receiving Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
11264323|NCT02668640|FG000|Participant Flow|Participants With RA Receiving Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
11264324|NCT02668640|OG000|Outcome|Participants With RA Receiving Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
11264325|NCT02668640|EG000|Reported Event|Participants With RA Receiving Adalimumab|40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
11264326|NCT02668692|BG000|Baseline|LEO 80185 Gel|LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264327|NCT02668692|BG001|Baseline|Dovobet® Ointment|Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264328|NCT02668692|BG002|Baseline|Total|Total of all reporting groups
11264329|NCT02668692|FG000|Participant Flow|LEO 80185 Gel|LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264330|NCT02668692|FG001|Participant Flow|Dovobet® Ointment|Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264331|NCT02668692|OG000|Outcome|LEO 80185 Gel|LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264332|NCT02668692|OG001|Outcome|Dovobet® Ointment|Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264333|NCT02668692|EG000|Reported Event|LEO 80185 Gel|LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264334|NCT02668692|EG001|Reported Event|Dovobet® Ointment|Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
11264335|NCT02668952|BG000|Baseline|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11264336|NCT02668952|BG001|Baseline|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11264337|NCT02668952|BG002|Baseline|Total|Total of all reporting groups
11264338|NCT02668952|FG000|Participant Flow|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11264339|NCT02668952|FG001|Participant Flow|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11264340|NCT02668952|OG000|Outcome|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11264341|NCT02668952|OG001|Outcome|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11264342|NCT02668952|EG000|Reported Event|Normal Saline Group|"0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.~0.9% Normal Saline (0.9% Sodium Chloride) injection"
11264343|NCT02668952|EG001|Reported Event|Isolyte Group|"Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.~Isolyte S injection"
11264344|NCT02669017|BG000|Baseline|Part 1: 15 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264345|NCT02669017|BG001|Baseline|Part 1: 30 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264346|NCT02669017|BG002|Baseline|Part 1: 60 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264347|NCT02669017|BG003|Baseline|Part 1: 90 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264348|NCT02669017|BG004|Baseline|Part 1: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264349|NCT02669017|BG005|Baseline|Part 2: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264350|NCT02669017|BG006|Baseline|Part 1: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264351|NCT02669017|BG007|Baseline|Part 2: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264352|NCT02669017|BG008|Baseline|Part 1: 200 μg/kg Q3W and Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
11264353|NCT02669017|BG009|Baseline|Total|Total of all reporting groups
11264354|NCT02669017|FG000|Participant Flow|Part 1: 15 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264355|NCT02669017|FG001|Participant Flow|Part 1: 30 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264356|NCT02669017|FG002|Participant Flow|Part 1: 60 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264357|NCT02669017|FG003|Participant Flow|Part 1: 90 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264358|NCT02669017|FG004|Participant Flow|Part 1: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264359|NCT02669017|FG005|Participant Flow|Part 2: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264360|NCT02669017|FG006|Participant Flow|Part 1: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264361|NCT02669017|FG007|Participant Flow|Part 2: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264362|NCT02669017|FG008|Participant Flow|Part 1: 200 μg/kg Q3W and Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
11264363|NCT02669017|OG000|Outcome|Part 1: 15 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264364|NCT02669017|OG001|Outcome|Part 1: 30 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264365|NCT02669017|OG002|Outcome|Part 1: 60 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264366|NCT02669017|OG003|Outcome|Part 1: 90 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264367|NCT02669017|OG004|Outcome|Part 1: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264368|NCT02669017|OG005|Outcome|Part 1: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264369|NCT02669017|OG006|Outcome|Part 1: 200 μg/kg Q3W and Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
11264370|NCT02669017|OG000|Outcome|Part 1: ADCT-402 Dose Escalation|"In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:~Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)~Dose Level 2: 30 μg/kg Day 1 Q3W~Dose Level 3: 60 μg/kg Day 1 Q3W~Dose Level 4: 90 μg/kg Day 1 Q3W~Dose Level 5: 120 μg/kg Day 1 Q3W~Dose Level 6: 150 μg/kg Day 1 Q3W~Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W)."
11264371|NCT02669017|OG005|Outcome|Part 2: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264372|NCT02669017|OG006|Outcome|Part 1: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264373|NCT02669017|OG007|Outcome|Part 2: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264374|NCT02669017|OG008|Outcome|Part 1: 200 μg/kg Q3W and Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
11337528|NCT03586830|FG002|Participant Flow|JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264375|NCT02669017|OG000|Outcome|Parts 1 and 2: ADCT-402|"In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:~Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)~Dose Level 2: 30 μg/kg Day 1 Q3W~Dose Level 3: 60 μg/kg Day 1 Q3W~Dose Level 4: 90 μg/kg Day 1 Q3W~Dose Level 5: 120 μg/kg Day 1 Q3W~Dose Level 6: 150 μg/kg Day 1 Q3W~Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).~In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W)."
11264376|NCT02669017|OG004|Outcome|Parts 1 and 2: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
11264377|NCT02669017|OG005|Outcome|Parts 1 and 2: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
11264378|NCT02669017|OG006|Outcome|Part 1: 200 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
11264379|NCT02669017|OG007|Outcome|Part 1: 200 μg/kg Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
11264380|NCT02669017|EG000|Reported Event|Part 1: 15 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264381|NCT02669017|EG001|Reported Event|Part 1: 30 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264382|NCT02669017|EG002|Reported Event|Part 1: 60 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264383|NCT02669017|EG003|Reported Event|Part 1: 90 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264384|NCT02669017|EG004|Reported Event|Part 1: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264385|NCT02669017|EG005|Reported Event|Part 2: 120 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264386|NCT02669017|EG006|Reported Event|Part 1: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264387|NCT02669017|EG007|Reported Event|Part 2: 150 μg/kg Q3W|Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
11264388|NCT02669017|EG008|Reported Event|Part 1: 200 μg/kg Q3W and Q6W|Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
11264389|NCT02669043|BG000|Baseline|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11264390|NCT02669043|FG000|Participant Flow|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11264391|NCT02669043|OG000|Outcome|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11264392|NCT02669043|EG000|Reported Event|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
11264393|NCT02669082|BG000|Baseline|Ramelteon 8 mg|Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
11264394|NCT02669082|FG000|Participant Flow|Ramelteon 8 mg|Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
11264395|NCT02669082|OG000|Outcome|Ramelteon 8 mg|Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
11264396|NCT02669082|EG000|Reported Event|Ramelteon 8 mg|Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
11264397|NCT02669095|BG000|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11264398|NCT02669095|BG001|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11264399|NCT02669095|BG002|Baseline|Total|Total of all reporting groups
11264400|NCT02669095|FG000|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11264401|NCT02669095|FG001|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11264402|NCT02669095|OG000|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11264403|NCT02669095|OG001|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11264404|NCT02669095|EG000|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
11264405|NCT02669095|EG001|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
11264406|NCT02669121|BG000|Baseline|Placebo|NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
11264407|NCT02669121|BG001|Baseline|NoV GI.1/GII.4 Bivalent VLP Vaccine|NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
11264408|NCT02669121|BG002|Baseline|Total|Total of all reporting groups
11264409|NCT02669121|FG000|Participant Flow|Placebo|NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1.
11264410|NCT02669121|FG001|Participant Flow|NoV GI.1/GII.4 Bivalent VLP Vaccine|NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1.
11264411|NCT02669121|OG000|Outcome|Placebo|NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
11264412|NCT02669121|OG001|Outcome|NoV GI.1/GII.4 Bivalent VLP Vaccine|NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
11264413|NCT02669121|EG000|Reported Event|Placebo|NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
11264414|NCT02669121|EG001|Reported Event|NoV GI.1/GII.4 Bivalent VLP Vaccine|NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
11264415|NCT02669264|BG000|Baseline|15 μg/kg Q3W|Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264416|NCT02669264|BG001|Baseline|30 μg/kg Q3W|Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264417|NCT02669264|BG002|Baseline|60 μg/kg Q3W|Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264418|NCT02669264|BG003|Baseline|90 μg/kg Q3W|Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264419|NCT02669264|BG004|Baseline|120 μg/kg Q3W|Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264420|NCT02669264|BG005|Baseline|150 μg/kg Q3W|Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264421|NCT02669264|BG006|Baseline|50 μg/kg QW|Participants received 50 μg/kg ADCT-402 on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the QW dosing was based on the safety and tolerability of participants who have been treated on the every 3-week (Q3W) schedule.
11264422|NCT02669264|BG007|Baseline|Total|Total of all reporting groups
11264423|NCT02669264|FG000|Participant Flow|15 μg/kg Q3W|Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264424|NCT02669264|FG001|Participant Flow|30 μg/kg Q3W|Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264425|NCT02669264|FG002|Participant Flow|60 μg/kg Q3W|Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264426|NCT02669264|FG003|Participant Flow|90 μg/kg Q3W|Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264427|NCT02669264|FG004|Participant Flow|120 μg/kg Q3W|Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264428|NCT02669264|FG005|Participant Flow|150 μg/kg Q3W|Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264429|NCT02669264|FG006|Participant Flow|50 μg/kg QW|Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
11264430|NCT02669264|OG000|Outcome|15 μg/kg Q3W|Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264431|NCT02669264|OG001|Outcome|30 μg/kg Q3W|Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264432|NCT02669264|OG002|Outcome|60 μg/kg Q3W|Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264433|NCT02669264|OG003|Outcome|90 μg/kg Q3W|Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264434|NCT02669264|OG004|Outcome|120 μg/kg Q3W|Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264435|NCT02669264|OG005|Outcome|150 μg/kg Q3W|Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264436|NCT02669264|OG006|Outcome|50 μg/kg QW|Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
11264437|NCT02669264|OG000|Outcome|Part 1: ADCT-402 Dose Escalation|"Weekly administration (QW) - Participants received an intravenous (IV) infusion of ADCT-402, on Days 1, 8, and 15 of each 3- week (21-day) cycle.~3-week administration (Q3W) - Participants received an IV infusion of ADCT-402, on Day 1 of each 3-week (21-day) cycle.~The dose escalation was conducted according to a 3+3 design."
11264438|NCT02669264|OG000|Outcome|50 μg/kg QW|Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
11264439|NCT02669264|EG000|Reported Event|15 μg/kg Q3W|Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264440|NCT02669264|EG001|Reported Event|30 μg/kg Q3W|Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264441|NCT02669264|EG002|Reported Event|60 μg/kg Q3W|Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264442|NCT02669264|EG003|Reported Event|90 μg/kg Q3W|Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264443|NCT02669264|EG004|Reported Event|120 μg/kg Q3W|Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264444|NCT02669264|EG005|Reported Event|150 μg/kg Q3W|Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
11264445|NCT02669264|EG006|Reported Event|50 μg/kg QW|Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
11264446|NCT02669329|BG000|Baseline|Upper Arm Treatment With Vacuum Applicator|The CoolSculpting device with vacuum applicator will be used to administer treatment.
11264447|NCT02669329|FG000|Participant Flow|Upper Arm Treatment Group|Each subject in the arm received bilateral treatment with the CoolSculpting device. Each arm was treated once.
11264448|NCT02669329|OG000|Outcome|Upper Arm Treatment With Vacuum Applicator|The CoolSculpting device with vacuum applicator will be used to administer treatment.
11264449|NCT02669329|EG000|Reported Event|Upper Arm Treatment With Vacuum Applicator|The CoolSculpting device with vacuum applicator will be used to administer treatment.
11286730|NCT02891915|OG000|Outcome|Short Course|"Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.~Placebo: Placebo"
11337529|NCT03586830|FG003|Participant Flow|JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11337530|NCT03586830|OG000|Outcome|Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264450|NCT02669407|BG000|Baseline|Regional Nerve Anesthesia|"Regional nerve anesthesia of splanchnic nerve~splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve~regional nerve block with a local anesthetic (Lidocaine)"
11264451|NCT02669407|FG000|Participant Flow|Regional Nerve Anesthesia|"Regional nerve anesthesia of splanchnic nerve~splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve~regional nerve block with a local anesthetic (Lidocaine)"
11264452|NCT02669407|OG000|Outcome|Regional Nerve Anesthesia|"Regional nerve anesthesia of splanchnic nerve~splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve~regional nerve block with a local anesthetic (Lidocaine)"
11264453|NCT02669407|EG000|Reported Event|Regional Nerve Anesthesia|"Regional nerve anesthesia of splanchnic nerve~splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve~regional nerve block with a local anesthetic (Lidocaine)"
11264454|NCT02669433|BG000|Baseline|Placebo|"Subjects dosed with two Placebo tablets~Placebo: once daily, oral, matching tablets"
11264455|NCT02669433|BG001|Baseline|RVT-101 35 mg|"Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101~RVT-101 35 mg: once daily, oral, 35-mg tablets"
11264456|NCT02669433|BG002|Baseline|RVT-101 70 mg|"Subjects dosed with two RVT-101 35 mg tablets~RVT-101 70 mg: once daily, oral, 35-mg tablets"
11264457|NCT02669433|BG003|Baseline|Total|Total of all reporting groups
11264458|NCT02669433|FG000|Participant Flow|Placebo|"Subjects dosed with two Placebo tablets~Placebo: once daily, oral, matching tablets"
11264459|NCT02669433|FG001|Participant Flow|RVT-101 35 mg|"Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101~RVT-101 35 mg: once daily, oral, 35-mg tablets"
11264460|NCT02669433|FG002|Participant Flow|RVT-101 70 mg|"Subjects dosed with two RVT-101 35 mg tablets~RVT-101 70 mg: once daily, oral, 35-mg tablets"
11264461|NCT02669433|OG000|Outcome|Placebo|"Subjects dosed with two Placebo tablets~Placebo: once daily, oral, matching tablets"
11264462|NCT02669433|OG001|Outcome|RVT-101 35 mg|"Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101~RVT-101 35 mg: once daily, oral, 35-mg tablets"
11264463|NCT02669433|OG002|Outcome|RVT-101 70 mg|"Subjects dosed with two RVT-101 35 mg tablets~RVT-101 70 mg: once daily, oral, 35-mg tablets"
11264464|NCT02669433|EG000|Reported Event|Placebo|"Placebo~Placebo: once daily, oral, matching tablets"
11264465|NCT02669433|EG001|Reported Event|RVT-101 35 mg|"RVT-101 35 mg once daily~RVT-101 35 mg: once daily, oral, 35-mg tablets"
11264466|NCT02669433|EG002|Reported Event|RVT-101 70 mg|"RVT-101 70 mg once daily~RVT-101 70 mg: once daily, oral, 35-mg tablets"
11264467|NCT02669615|BG000|Baseline|Melphalan HCl for Injection (Propylene Glycol Free)|"Patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0).~Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2."
11264468|NCT02669615|FG000|Participant Flow|Melphalan HCl for Injection (Propylene Glycol Free)|"Patients will receive 200 mg/m^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0).~Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2."
11264469|NCT02669615|OG000|Outcome|Melphalan HCl for Injection (Propylene Glycol Free)|"Patients will receive 200 mg/m^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0).~Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2."
11264470|NCT02669615|EG000|Reported Event|Melphalan HCl for Injection (Propylene Glycol Free)|"Patients will receive 200 mg/m^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0).~Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2."
11264471|NCT02669667|BG000|Baseline|Placebo|Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
11264472|NCT02669667|BG001|Baseline|Cohort 1|Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
11264473|NCT02669667|BG002|Baseline|Cohort 2|Participants received a single SC injection of MEDI9314 150 mg on Day 1.
11264474|NCT02669667|BG003|Baseline|Cohort 3|Participants received a single SC injection of MEDI9314 300 mg on Day 1.
11264475|NCT02669667|BG004|Baseline|Cohort 4|Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
11264476|NCT02669667|BG005|Baseline|Cohort 5|Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
11264477|NCT02669667|BG006|Baseline|Cohort 6|Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
11264478|NCT02669667|BG007|Baseline|Total|Total of all reporting groups
11264479|NCT02669667|FG000|Participant Flow|Placebo|Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
11264480|NCT02669667|FG001|Participant Flow|Cohort 1|Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
11264481|NCT02669667|FG002|Participant Flow|Cohort 2|Participants received a single SC injection of MEDI9314 150 mg on Day 1.
11264482|NCT02669667|FG003|Participant Flow|Cohort 3|Participants received a single SC injection of MEDI9314 300 mg on Day 1.
11264483|NCT02669667|FG004|Participant Flow|Cohort 4|Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
11264484|NCT02669667|FG005|Participant Flow|Cohort 5|Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
11264485|NCT02669667|FG006|Participant Flow|Cohort 6|Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
11264486|NCT02669667|OG000|Outcome|Placebo|Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
11264487|NCT02669667|OG001|Outcome|Cohort 1|Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
11264488|NCT02669667|OG002|Outcome|Cohort 2|Participants received a single SC injection of MEDI9314 150 mg on Day 1.
11264489|NCT02669667|OG003|Outcome|Cohort 3|Participants received a single SC injection of MEDI9314 300 mg on Day 1.
11264490|NCT02669667|OG004|Outcome|Cohort 4|Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
11264491|NCT02669667|OG005|Outcome|Cohort 5|Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
11264492|NCT02669667|OG006|Outcome|Cohort 6|Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
11264493|NCT02669667|OG000|Outcome|Cohort 1|Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
11264494|NCT02669667|OG001|Outcome|Cohort 2|Participants received a single SC injection of MEDI9314 150 mg on Day 1.
11264495|NCT02669667|OG002|Outcome|Cohort 3|Participants received a single SC injection of MEDI9314 300 mg on Day 1.
11264496|NCT02669667|OG003|Outcome|Cohort 4|Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
11264497|NCT02669667|OG004|Outcome|Cohort 5|Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
11264498|NCT02669667|OG005|Outcome|Cohort 6|Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
11264499|NCT02669667|EG000|Reported Event|Placebo|Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
11264500|NCT02669667|EG001|Reported Event|Cohort 1|Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
11264501|NCT02669667|EG002|Reported Event|Cohort 2|Participants received a single SC injection of MEDI9314 150 mg on Day 1.
11264502|NCT02669667|EG003|Reported Event|Cohort 3|Participants received a single SC injection of MEDI9314 300 mg on Day 1.
11264503|NCT02669667|EG004|Reported Event|Cohort 4|Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
11264504|NCT02669667|EG005|Reported Event|Cohort 5|Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
11264505|NCT02669667|EG006|Reported Event|Cohort 6|Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
11264506|NCT02669758|BG000|Baseline|ALKS 3831|"Administered as a coated bilayer tablet.~ALKS 3831: Daily dosing"
11264507|NCT02669758|FG000|Participant Flow|ALKS 3831|"Administered as a coated bilayer tablet.~ALKS 3831: Daily dosing"
11264508|NCT02669758|OG000|Outcome|ALKS 3831|"Administered as a coated bilayer tablet.~ALKS 3831: Daily dosing"
11264509|NCT02669758|EG000|Reported Event|ALKS 3831|"Administered as a coated bilayer tablet.~ALKS 3831: Daily dosing"
11264510|NCT02669784|BG000|Baseline|Low Dose Contrast (40mL)|CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
11264511|NCT02669784|BG001|Baseline|Low Dose Contrast (50mL)|CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
11264512|NCT02669784|BG002|Baseline|Total|Total of all reporting groups
11264513|NCT02669784|FG000|Participant Flow|Contrast (Omnipaque) Low Dose (40mL)|"CTA of the chest: 40 mL of intravenous contrast (omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.~This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast."
11264514|NCT02669784|FG001|Participant Flow|Contrast (Omnipaque) Low Dose (50mL)|"CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.~This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast."
11264515|NCT02669784|OG000|Outcome|Contrast (Omnipaque) Low Dose (40mL)|"CTA of the chest: 40 mL of intravenous contrast (omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.~This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast."
11264516|NCT02669784|OG001|Outcome|Contrast (Omnipaque) Low Dose (50mL)|"CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.~This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast."
11264517|NCT02669784|EG000|Reported Event|Low Dose Contrast (40mL)|CTA of the chest: 40 mL of intravenous contrast (omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. . The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
11264518|NCT02669784|EG001|Reported Event|Low Dose Contrast (50mL)|CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
11264519|NCT02669849|BG000|Baseline|Placebo|Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264520|NCT02669849|BG001|Baseline|VX-210 3 mg|Participants who received VX-210 3 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264521|NCT02669849|BG002|Baseline|VX-210 9 mg|Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264522|NCT02669849|BG003|Baseline|Total|Total of all reporting groups
11264523|NCT02669849|FG000|Participant Flow|Placebo|Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264524|NCT02669849|FG001|Participant Flow|VX-210 3 mg|Participants who received VX-210 3 milligram (mg) as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264525|NCT02669849|FG002|Participant Flow|VX-210 9 mg|Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264526|NCT02669849|OG000|Outcome|Placebo|Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264527|NCT02669849|OG001|Outcome|VX-210 9 mg|Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264528|NCT02669849|OG000|Outcome|VX-210 9 mg|Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264529|NCT02669849|EG000|Reported Event|Placebo|Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264530|NCT02669849|EG001|Reported Event|VX-210 3 mg|Participants who received VX-210 3 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264531|NCT02669849|EG002|Reported Event|VX-210 9 mg|Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
11264532|NCT02669862|BG000|Baseline|A-101 Solution 40|"A-101 Solution 40% administered once per week~A-101 Solution 40"
11264533|NCT02669862|BG001|Baseline|A-101 Solution 45|"A-101 Solution 45% administered once per week~A-101 Solution 45"
11264534|NCT02669862|BG002|Baseline|Vehicle Solution|"Vehicle Solution administered once per week~Vehicle Solution"
11264535|NCT02669862|BG003|Baseline|Total|Total of all reporting groups
11264536|NCT02669862|FG000|Participant Flow|A-101 Solution 40|"A-101 Solution 40% administered once per week~A-101 Solution 40"
11264537|NCT02669862|FG001|Participant Flow|A-101 Solution 45|"A-101 Solution 45% administered once per week~A-101 Solution 45"
11264538|NCT02669862|FG002|Participant Flow|Vehicle Solution|"Vehicle Solution administered once per week~Vehicle Solution"
11264539|NCT02669862|OG000|Outcome|A-101 Solution 40|"A-101 Solution 40% administered once per week~A-101 Solution 40"
11264540|NCT02669862|OG001|Outcome|A-101 Solution 45|"A-101 Solution 45% administered once per week~A-101 Solution 45"
11264541|NCT02669862|OG002|Outcome|Vehicle Solution|"Vehicle Solution administered once per week~Vehicle Solution"
11264542|NCT02669862|OG000|Outcome|A-101 Solution 40|A-101 Solution 40% administered once per week
11264543|NCT02669862|OG001|Outcome|A-101 Solution 45|A-101 Solution 45% administered once per week
11264544|NCT02669862|OG002|Outcome|Vehicle Solution|Vehicle Solution administered once per week
11264545|NCT02669862|EG000|Reported Event|A-101 Solution 40|"A-101 Solution 40% administered once per week~A-101 Solution 40"
11264546|NCT02669862|EG001|Reported Event|A-101 Solution 45|"A-101 Solution 45% administered once per week~A-101 Solution 45"
11264547|NCT02669862|EG002|Reported Event|Vehicle Solution|"Vehicle Solution administered once per week~Vehicle Solution"
11264548|NCT02669914|BG000|Baseline|Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264549|NCT02669914|BG001|Baseline|Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264550|NCT02669914|BG002|Baseline|Cohort C: NSCLC or Non-NSCLC w/Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264551|NCT02669914|BG003|Baseline|Total|Total of all reporting groups
11264552|NCT02669914|FG000|Participant Flow|Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264553|NCT02669914|FG001|Participant Flow|Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264554|NCT02669914|FG002|Participant Flow|Cohort C: NSCLC or Non-NSCLC w/Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
10970015|NCT00908466|EG000|Reported Event|Intravitreal Injection|"Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120."
11264555|NCT02669914|OG000|Outcome|Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264556|NCT02669914|OG001|Outcome|Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264557|NCT02669914|OG002|Outcome|Cohort C: NSCLC or Non-NSCLC w/Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264558|NCT02669914|EG000|Reported Event|Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264559|NCT02669914|EG001|Reported Event|Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264560|NCT02669914|EG002|Reported Event|Cohort C: NSCLC or Non-NSCLC w/Corticosteroids|-MEDI4736 will be given to all patients > 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients < 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
11264561|NCT02669940|BG000|Baseline|Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.
11264562|NCT02669940|BG001|Baseline|Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
11264563|NCT02669940|BG002|Baseline|Total|Total of all reporting groups
11264564|NCT02669940|FG000|Participant Flow|Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/ritonavir [r] - ombitasvir with or without dasabuvir with ribavirin (RBV) according to standard of care and in line with the current local label.
11264565|NCT02669940|FG001|Participant Flow|Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
11264566|NCT02669940|OG000|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.
11337531|NCT03586830|OG001|Outcome|JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
10970016|NCT00908466|EG001|Reported Event|Subconjunctival Injection|"Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.~Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120."
11337532|NCT03586830|OG002|Outcome|JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264567|NCT02669940|OG001|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
11264568|NCT02669940|OG002|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
11264569|NCT02669940|OG000|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.
11264570|NCT02669940|OG001|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
11264571|NCT02669940|OG000|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with RBV according to standard of care and in line with the current local label.
11264572|NCT02669940|OG002|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with or without RBV according to standard of care and in line with the current local label.
11264573|NCT02669940|OG001|Outcome|Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) without RBV according to standard of care and in line with the current local label.
11264574|NCT02669940|EG000|Reported Event|Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.
11264575|NCT02669940|EG001|Reported Event|Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
11264576|NCT02669940|EG002|Reported Event|Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV|Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
11264577|NCT02670083|BG000|Baseline|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
10970017|NCT00908544|BG000|Baseline|CHI-patients|"Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also Eligibility) intensified by Maraviroc + Raltegravir~CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.~2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
11264578|NCT02670083|BG001|Baseline|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11264579|NCT02670083|BG002|Baseline|Total|Total of all reporting groups
11264580|NCT02670083|FG000|Participant Flow|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11264581|NCT02670083|FG001|Participant Flow|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11264582|NCT02670083|OG000|Outcome|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11264583|NCT02670083|OG001|Outcome|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11264584|NCT02670083|OG000|Outcome|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11264585|NCT02670083|EG000|Reported Event|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11264586|NCT02670083|EG001|Reported Event|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11264587|NCT02670122|BG000|Baseline|Patients With Non Resectable HCC|"DEB-TACE with doxorubicin eluting 100 µ microspheres~DEB-TACE: Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin."
11264588|NCT02670122|FG000|Participant Flow|Patients With Non Resectable HCC|"DEB-TACE with doxorubicin eluting 100 µ microspheres~DEB-TACE: Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin."
11264589|NCT02670122|OG000|Outcome|Major Complications|Common Terminology Criteria for Adverse Events 4.03 grade 3 or 4 adverse events
11264590|NCT02670122|OG001|Outcome|Minor Complications|Common Terminology Criteria for Adverse Events 4.03 grade 1 or 2 adverse events
11264591|NCT02670122|OG002|Outcome|Procedure Related Mortality|Patients that died due to the DEB-TACE procedure
11264592|NCT02670122|OG003|Outcome|Severe PES|Severe Post Embolisation Syndrome is when due to the pain and/or fever caused by the DEB TACE procedure requires intravenous analgesia and extend hospital admission.
11264593|NCT02670122|OG000|Outcome|6 m ORR|Objective Response Rate as the sum of complete and partial response rate 6 months after the first DEB-TACE
11264594|NCT02670122|OG001|Outcome|12 m ORR|Objective Response Rate as the sum of complete and partial response rate 12 months after the first DEB-TACE
11264595|NCT02670122|OG002|Outcome|24 m ORR|Objective Response Rate as the sum of complete and partial response rate 24 months after the first DEB-TACE
11264596|NCT02670122|OG000|Outcome|Overall Survival|OS is defined as the cumulative 24-month survival rate.
11264597|NCT02670122|EG000|Reported Event|Adverse Events|Mortality, minor and major adverse events after Tandem-100 DEB-TACE were assessed in accordance with CTCAE 4.03 criteria
11337533|NCT03586830|OG003|Outcome|JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264598|NCT02670330|BG000|Baseline|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264599|NCT02670330|BG001|Baseline|Placebo to SD-101-6.0|Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264600|NCT02670330|BG002|Baseline|Total|Total of all reporting groups
11264601|NCT02670330|FG000|Participant Flow|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264602|NCT02670330|FG001|Participant Flow|Placebo to SD-101-6.0|Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264603|NCT02670330|OG000|Outcome|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264604|NCT02670330|OG001|Outcome|Placebo to SD-101-6.0|Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264605|NCT02670330|EG000|Reported Event|SD-101-6.0 to SD-101-6.0|Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264606|NCT02670330|EG001|Reported Event|Placebo to SD-101-6.0|Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
11264607|NCT02670343|BG000|Baseline|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11264608|NCT02670343|FG000|Participant Flow|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11264609|NCT02670343|OG000|Outcome|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11264610|NCT02670343|EG000|Reported Event|Oral Testosterone Undecanoate|"A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.~Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone."
11264611|NCT02670382|BG000|Baseline|All Participants|Baseline characteristic, defined as end of lead-in phase
11264612|NCT02670382|FG000|Participant Flow|Placebo, Then EPA, Then DHA|3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure EPA for 10 weeks; then washout of 10 weeks; then pure DHA 3000 mg/day Placebo and EPA and DHA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
11264613|NCT02670382|FG001|Participant Flow|Placebo, Then DHA, and Then EPA|3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure DHA for 10 weeks; then washout of 10 weeks; then pure EPA 3000 mg/day Placebo and DHA and EPA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
11264614|NCT02670382|OG000|Outcome|Placebo|"3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.~sunflower oil: 4-week lead-in"
10970018|NCT00908544|BG001|Baseline|PHI-patients|"Patients with primary HIV infection (PHI) (see also Eligibility) are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir~PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
11264615|NCT02670382|OG001|Outcome|EPA Intervention|"Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.~EPA: 10 week supplementation"
11264616|NCT02670382|OG002|Outcome|DHA Intervention|"Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.~DHA: 10 week supplementation"
11264617|NCT02670382|EG000|Reported Event|EPA Intervention|"Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.~EPA: 10 week supplementation"
11264618|NCT02670382|EG001|Reported Event|DHA Intervention|"Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.~DHA: 10 week supplementation"
11264619|NCT02670382|EG002|Reported Event|Placebo|"3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.~sunflower oil: 4-week lead-in"
11264620|NCT02670473|BG000|Baseline|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11264621|NCT02670473|FG000|Participant Flow|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11264622|NCT02670473|OG000|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
11264623|NCT02670473|OG001|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
10970019|NCT00908544|BG002|Baseline|Total|Total of all reporting groups
11264624|NCT02670473|OG002|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
11264625|NCT02670473|OG003|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
11264626|NCT02670473|OG000|Outcome|Completely Satisfied|
11264627|NCT02670473|OG001|Outcome|Somewhat Satisfied|
11264628|NCT02670473|OG002|Outcome|Somewhat Dissatisfied|
11264629|NCT02670473|OG003|Outcome|Completely Dissatisfied|
11264630|NCT02670473|OG000|Outcome|Habitual Lenses|enfilcon A habitual lens (control)
11264631|NCT02670473|OG001|Outcome|Fanfilcon A Lens (Test)|fanfilcon A lens (test)
11264632|NCT02670473|EG000|Reported Event|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
11264633|NCT02670538|BG000|Baseline|Placebo|Following a 7 to 14 day screening/washout period, matching placebo capsule, one per day, orally for 6 weeks.
11264634|NCT02670538|BG001|Baseline|Cariprazine 1.5 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.
11264635|NCT02670538|BG002|Baseline|Cariprazine 3.0 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
11264636|NCT02670538|BG003|Baseline|Total|Total of all reporting groups
11264637|NCT02670538|FG000|Participant Flow|Placebo|Following a 7 to 14 day screening/washout period, matching placebo capsule, one per day, orally for 6 weeks.
11264638|NCT02670538|FG001|Participant Flow|Cariprazine 1.5 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.
11264639|NCT02670538|FG002|Participant Flow|Cariprazine 3.0 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
11264640|NCT02670538|OG000|Outcome|Placebo|Following a 7 to 14 day screening/washout period, matching placebo capsule, one per day, orally for 6 weeks.
11264641|NCT02670538|OG001|Outcome|Cariprazine 1.5 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.
11264642|NCT02670538|OG002|Outcome|Cariprazine 3.0 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
11264643|NCT02670538|EG000|Reported Event|Placebo|Following a 7 to 14 day screening/washout period, matching placebo capsule, one per day, orally for 6 weeks.
11264644|NCT02670538|EG001|Reported Event|Cariprazine 1.5 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.
10970020|NCT00908544|FG000|Participant Flow|CHI-patients|"Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also Eligibility) intensified by Maraviroc + Raltegravir~CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.~2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
11264645|NCT02670538|EG002|Reported Event|Cariprazine 3.0 mg|Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
11264646|NCT02670551|BG000|Baseline|Placebo|Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
11264647|NCT02670551|BG001|Baseline|Cariprazine 1.5 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
11264648|NCT02670551|BG002|Baseline|Cariprazine 3.0 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.
11264649|NCT02670551|BG003|Baseline|Total|Total of all reporting groups
11264650|NCT02670551|FG000|Participant Flow|Placebo|Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
11264651|NCT02670551|FG001|Participant Flow|Cariprazine 1.5 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
11264652|NCT02670551|FG002|Participant Flow|Cariprazine 3.0 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.
11264653|NCT02670551|OG000|Outcome|Placebo|Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
11264654|NCT02670551|OG001|Outcome|Cariprazine 1.5 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
11264655|NCT02670551|OG002|Outcome|Cariprazine 3.0 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.
11264656|NCT02670551|EG000|Reported Event|Placebo|Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
11264657|NCT02670551|EG001|Reported Event|Cariprazine 1.5 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
11264658|NCT02670551|EG002|Reported Event|Cariprazine 3.0 mg|Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.
11264659|NCT02670629|BG000|Baseline|Anatomic Closed Reduction + Short Cast|"Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was performing a closed anatomic reduction under anesthesia.~Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks."
11337534|NCT03586830|EG000|Reported Event|Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11264660|NCT02670629|BG001|Baseline|Partial Reduction Overriding Position|"Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was not performing a closed anatomic reduction under anesthesia.~Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks."
11264661|NCT02670629|BG002|Baseline|Total|Total of all reporting groups
11264662|NCT02670629|FG000|Participant Flow|Anatomic Closed Reduction + Short Cast|"Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was performing a closed anatomic reduction under anesthesia.~Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks."
11264663|NCT02670629|FG001|Participant Flow|Partial Reduction Overriding Position|"Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was not performing a closed anatomic reduction under anesthesia.~Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks."
11264664|NCT02670629|OG000|Outcome|Anatomic Closed Reduction + Short Cast|"Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was performing a closed anatomic reduction under anesthesia.~Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks."
11264665|NCT02670629|OG001|Outcome|Partial Reduction Overriding Position|"Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was not performing a closed anatomic reduction under anesthesia.~Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks."
11264666|NCT02670629|EG000|Reported Event|Anatomic Closed Reduction + Short Cast|"Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was performing a closed anatomic reduction under anesthesia.~Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks."
11264667|NCT02670629|EG001|Reported Event|Partial Reduction Overriding Position|"Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.~The intervention in this control group was not performing a closed anatomic reduction under anesthesia.~Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks."
11264668|NCT02670811|BG000|Baseline|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11264669|NCT02670811|BG001|Baseline|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11264670|NCT02670811|BG002|Baseline|Total|Total of all reporting groups
11264671|NCT02670811|FG000|Participant Flow|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11264672|NCT02670811|FG001|Participant Flow|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11264673|NCT02670811|OG000|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11264674|NCT02670811|OG001|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11264675|NCT02670811|EG000|Reported Event|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
11264676|NCT02670811|EG001|Reported Event|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
11264677|NCT02670915|BG000|Baseline|Faster Aspart (Meal)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264678|NCT02670915|BG001|Baseline|Faster Aspart (Post)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264679|NCT02670915|BG002|Baseline|NovoRapid (Meal)|Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264680|NCT02670915|BG003|Baseline|Total|Total of all reporting groups
11264681|NCT02670915|FG000|Participant Flow|Faster Aspart (Meal)|Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264682|NCT02670915|FG001|Participant Flow|Faster Aspart (Post)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264683|NCT02670915|FG002|Participant Flow|NovoRapid (Meal)|Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264684|NCT02670915|OG000|Outcome|Faster Aspart (Meal)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264685|NCT02670915|OG001|Outcome|Faster Aspart (Post)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
10970021|NCT00908544|FG001|Participant Flow|PHI-patients|"Patients with primary HIV infection (PHI) (see also Eligibility) are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir~PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
11286731|NCT02891915|OG001|Outcome|Standard Course|"Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body."
11264686|NCT02670915|OG002|Outcome|NovoRapid (Meal)|Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264687|NCT02670915|EG000|Reported Event|Faster Aspart (Meal)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264688|NCT02670915|EG001|Reported Event|Faster Aspart (Post)|Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264689|NCT02670915|EG002|Reported Event|NovoRapid (Meal)|Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
11264690|NCT02670928|BG000|Baseline|Active Group of Patients|Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
11264691|NCT02670928|BG001|Baseline|Control Group of Patients|Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
11264692|NCT02670928|BG002|Baseline|Total|Total of all reporting groups
11264693|NCT02670928|FG000|Participant Flow|Active Group of Patients|Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
11264694|NCT02670928|FG001|Participant Flow|Control Group of Patients|Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
11264695|NCT02670928|OG000|Outcome|Active Group of Patients|Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
11264696|NCT02670928|OG001|Outcome|Control Group of Patients|Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
11264697|NCT02670928|EG000|Reported Event|Active Group of Patients|Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
11264698|NCT02670928|EG001|Reported Event|Control Group of Patients|Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
11264699|NCT02671032|BG000|Baseline|Implantation With Nucleus CI532 Cochlear Implant|"All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.~Nucleus CI532 cochlear implant"
11264700|NCT02671032|FG000|Participant Flow|Implantation With Nucleus CI532 Cochlear Implant|"All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.~Nucleus CI532 cochlear implant"
11264701|NCT02671032|OG000|Outcome|Implantation With Nucleus CI532 Cochlear Implant|"All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.~Nucleus CI532 cochlear implant"
11264702|NCT02671032|EG000|Reported Event|Implantation With Nucleus CI532 Cochlear Implant|"All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.~Nucleus CI532 cochlear implant"
11264703|NCT02671266|BG000|Baseline|Oxytocin, Then Placebo|"Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11286732|NCT02891915|EG000|Reported Event|Short Course|"Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.~Placebo: Placebo"
11264704|NCT02671266|BG001|Baseline|Placebo, Then Oxytocin|"Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264705|NCT02671266|BG002|Baseline|Total|Total of all reporting groups
11264706|NCT02671266|FG000|Participant Flow|Oxytocin, Then Placebo|"Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264707|NCT02671266|FG001|Participant Flow|Placebo, Then Oxytocin|"Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264708|NCT02671266|OG000|Outcome|Oxytocin, Then Placebo|"Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264709|NCT02671266|OG001|Outcome|Placebo, Then Oxytocin|"Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264710|NCT02671266|EG000|Reported Event|Oxytocin|"Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).~Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray."
11264711|NCT02671266|EG001|Reported Event|Placebo|"Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).~Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient."
11264712|NCT02671422|BG000|Baseline|200mg Vargatef®|"Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.~Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first."
11264713|NCT02671422|FG000|Participant Flow|200mg Vargatef®|"Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.~Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first."
11264714|NCT02671422|OG000|Outcome|200mg Vargatef®|"Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.~Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first."
11264715|NCT02671422|EG000|Reported Event|200mg Vargatef®|"Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.~Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first."
11264716|NCT02671500|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
11264717|NCT02671500|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
11264718|NCT02671500|OG000|Outcome|SOF/VEL (Overall)|All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
11264719|NCT02671500|OG001|Outcome|SOF/VEL (China - Region 1)|All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
11264720|NCT02671500|OG002|Outcome|SOF/VEL (Southeast Asia - Region 2)|All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
11264721|NCT02671500|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
11264722|NCT02671500|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11264723|NCT02671500|EG000|Reported Event|SOL/VEL|SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
11264724|NCT02671760|BG000|Baseline|All Study Participants|All study participants regardless of randomization sequence.
10970022|NCT00908544|OG000|Outcome|CHI-patients|"Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also Eligibility) intensified by Maraviroc + Raltegravir~CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.~2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
10970023|NCT00908544|OG001|Outcome|PHI-patients|"Patients with primary HIV infection (PHI) (see also Eligibility) are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir~PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
10970024|NCT00908544|EG000|Reported Event|CHI-patients|"Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also Eligibility) intensified by Maraviroc + Raltegravir~CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.~2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
10970025|NCT00908544|EG001|Reported Event|PHI-patients|"Patients with primary HIV infection (PHI) (see also Eligibility) are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir~PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir"
10970026|NCT00908583|BG000|Baseline|All Study Participants|Combined study participants, all phases.
10970027|NCT00908583|FG000|Participant Flow|All Study Participants|Combined study participants all phases.
10970028|NCT00908583|OG000|Outcome|Phase 1, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
11264725|NCT02671760|FG000|Participant Flow|Experimental: SM-1 Then Comparator Then Placebo|Subjects received a single dose of SM-1 followed by a 5-16 day washout. They the received a single dose of Comparator followed by a 5-16 day washout. They then received a single dose of Placebo.
11264726|NCT02671760|FG001|Participant Flow|Experimental: Comparator Then Placebo Then SM-1|Subjects received a single dose of Comparator followed by a 5-16 day washout. They the received a single dose of Placebo followed by a 5-16 day washout. They then received a single dose of SM-1.
11264727|NCT02671760|FG002|Participant Flow|Experimental: Placebo Then SM-1 Then Comparator|Subjects received a single dose of Placebo followed by a 5-16 day washout. They the received a single dose of SM-1 followed by a 5-16 day washout. They then received a single dose of Comparator.
11264728|NCT02671760|OG000|Outcome|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11264729|NCT02671760|OG001|Outcome|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11264730|NCT02671760|OG002|Outcome|Placebo|"Placebo~Placebo: Placebo"
10970029|NCT00908583|OG001|Outcome|Phase 1 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970030|NCT00908583|OG002|Outcome|Phase 2, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970031|NCT00908583|OG003|Outcome|Phase 2 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970032|NCT00908583|OG004|Outcome|Phase 3, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970033|NCT00908583|OG005|Outcome|Phase 3, Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970034|NCT00908583|OG006|Outcome|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970035|NCT00908583|OG007|Outcome|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970036|NCT00908583|OG000|Outcome|All Study Participants|All study participants combined. Counting participants only once even though 7 participants were enrolled in multiple phases.
11264731|NCT02671760|EG000|Reported Event|Treatment|"SM-1~SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam"
11264732|NCT02671760|EG001|Reported Event|Comparator|"2-drug combination~Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam"
11264733|NCT02671760|EG002|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11264734|NCT02672111|BG000|Baseline|CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX|Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w
11264735|NCT02672111|BG001|Baseline|CAM2038 q1w or q4w New to BPN Treatment|New to BPN Treatment who received CAM2028 q1w or q4w
11264736|NCT02672111|BG002|Baseline|Total|Total of all reporting groups
11264737|NCT02672111|FG000|Participant Flow|CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX|Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w
11264738|NCT02672111|FG001|Participant Flow|CAM2038 q1w or q4w New to BPN Treatment|New to BPN Treatment who received CAM2038 q1w or q4w
11264739|NCT02672111|OG000|Outcome|CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX|Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w
11264740|NCT02672111|OG001|Outcome|CAM2038 q1w or q4w New to BPN Treatment|New to BPN Treatment who received CAM2038 q1w or q4w
11264741|NCT02672111|OG001|Outcome|CAM2038 q1w or q4w New to BPN Treatment|New to BPN Treatment who received CAM2028 q1w or q4w
11264742|NCT02672111|EG000|Reported Event|CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX|Subjects exposed to SL BPN/NX who received CAM2038 q1w or q4w
11264743|NCT02672111|EG001|Reported Event|CAM2038 q1w or q4w New to BPN Treatment|New to BPN Treatment who received either CAM2028 q1w or q4w
11264744|NCT02672176|BG000|Baseline|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.~Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient."
11264745|NCT02672176|BG001|Baseline|P2E2T2 Program|"The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org).~P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:"
11264746|NCT02672176|BG002|Baseline|Total|Total of all reporting groups
11264747|NCT02672176|FG000|Participant Flow|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.~Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient."
11264748|NCT02672176|FG001|Participant Flow|P2E2T2 Program|"The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org).~P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using motivational interviewing (MI), an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:"
11264749|NCT02672176|OG000|Outcome|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.~Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient."
11264750|NCT02672176|OG001|Outcome|P2E2T2 Program|"The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org).~P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:"
10970037|NCT00908583|OG000|Outcome|All Study Participants|All study participants combined.4 participants were enrolled in multiple groups or phases. They are only counted once.
10970038|NCT00908583|OG000|Outcome|All Transplanted Participants|Combined phases, transplanted patients.
10970039|NCT00908583|EG000|Reported Event|Phase 1, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970040|NCT00908583|EG001|Reported Event|Phase 2, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
11264751|NCT02672176|OG000|Outcome|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.~Usual Care: This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient."
11264752|NCT02672176|OG000|Outcome|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. C~Usual Care: This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient."
11264753|NCT02672176|OG000|Outcome|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.~Usual Care: This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis."
11264754|NCT02672176|EG000|Reported Event|Usual Care-Chronic Disease Management|"Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.~Usual Care: This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis."
11264755|NCT02672176|EG001|Reported Event|P2E2T2 Program|"The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org).~P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:"
11264756|NCT02672423|BG000|Baseline|Part A: Abemaciclib|Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
11264757|NCT02672423|BG001|Baseline|Part B Abemaciclib|R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
11264758|NCT02672423|BG002|Baseline|Part C Abemaciclib|T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
11264759|NCT02672423|BG003|Baseline|Total|Total of all reporting groups
11264760|NCT02672423|FG000|Participant Flow|Part A: Abemaciclib (R,T150 )|Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
11264761|NCT02672423|FG001|Participant Flow|Part A: Abemaciclib (T150,R)|T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 2 periods.
11264762|NCT02672423|FG002|Participant Flow|Part B: Abemaciclib (R,T150,T50 )|R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
11264763|NCT02672423|FG003|Participant Flow|Part B: Abemaciclib (T150,T50,R)|T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
10970041|NCT00908583|EG002|Reported Event|Phase 3|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970042|NCT00908583|EG003|Reported Event|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
11264764|NCT02672423|FG004|Participant Flow|Part B: Abemaciclib (T50,R,T150)|T50 = 3 x 50 mg abemaciclib tablets, R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
11264765|NCT02672423|FG005|Participant Flow|Part B: Abemaciclib (R,T50,T150)|R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
11264766|NCT02672423|FG006|Participant Flow|Part B: Abemaciclib (T150,R,T50)|T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
11264767|NCT02672423|FG007|Participant Flow|Part B: Abemaciclib (T50,T150,R)|T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 3 periods.
11264768|NCT02672423|FG008|Participant Flow|Part C: Abemaciclib (T150 Fed, T150 Fasted)|T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
11264769|NCT02672423|FG009|Participant Flow|Part C: Abemaciclib (T150 Fasted, T150 Fed)|T150 Fasted and T150 Fed = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
11264770|NCT02672423|OG000|Outcome|Part A: 150 mg Abemaciclib (T150)|150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period.
10970043|NCT00908583|EG004|Reported Event|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
10970044|NCT00908596|BG000|Baseline|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11264771|NCT02672423|OG001|Outcome|Part A: 3 x 50 mg Abemaciclib (R)|3 x 50 mg abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period.
11264772|NCT02672423|OG002|Outcome|Part B: 150 mg Abemaciclib (T150)|150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period.
11264773|NCT02672423|OG003|Outcome|Part B: 3 x 50 mg Abemaciclib (T50)|3 x 50 mg abemaciclib tablets (T50) administered orally on Day 1 of 1 period.
11264774|NCT02672423|OG004|Outcome|Part B: 3 x 50 mg Abemaciclib (R)|3 x 50 mg abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period.
11264775|NCT02672423|OG005|Outcome|Part C: 150 mg Abemaciclib (Fed)|150 mg abemaciclib tablet (test formulation [T150]) with a meal administered orally on Day 1 of 1 period.
11264776|NCT02672423|OG006|Outcome|Part C: 150 mg Abemaciclib (Fasted)|150 mg abemaciclib tablet (test formulation[T150]) without a meal administered orally on Day 1 of 1 period.
11264777|NCT02672423|OG001|Outcome|Part A: 3 x 50 mg Abemaciclib (R)|3 x 50 mg abemaciclib capsules (reference formulation [R]) administered orally on Day 1 of 1 period.
11264778|NCT02672423|OG002|Outcome|Part B:150 mg Abemaciclib (T150)|150 mg abemaciclib tablet (test formulation [T150]) administered orally on Day 1 of 1 period.
11264779|NCT02672423|OG004|Outcome|Part B: 3 x 50 mg Abemaciclib (R)|3 x 50 mg abemaciclib capsules (reference formulation [R]) administered orally on Day 1 of 1 period.
11264780|NCT02672423|OG005|Outcome|Part C:150 mg Abemaciclib (Fed)|150 mg abemaciclib tablet (test formulation[T150]) with a meal administered orally on Day 1 of 1 period.
11264781|NCT02672423|OG006|Outcome|Part C:150 mg Abemaciclib (Fasted)|150 mg abemaciclib tablet (test formulation[T150]) without a meal administered orally on Day 1 of 1 period.
11264782|NCT02672423|EG000|Reported Event|Part A: 3 x 50 mg (R)|3 x 50 milligrams (mg) abemaciclib capsules (reference formulation [R]) administered orally on Day 1 of 1 period.
11264783|NCT02672423|EG001|Reported Event|Part A: 1 x 150 mg (T150)|150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period.
11264784|NCT02672423|EG002|Reported Event|Part B: 3 x 50 mg (R)|3 x 50 milligrams (mg) abemaciclib capsules (reference formulation[R]) administered orally on Day 1 of 1 period.
11264785|NCT02672423|EG003|Reported Event|Part B 1 x 150 mg (T150)|150 mg abemaciclib tablet (test formulation[T150]) administered orally on Day 1 of 1 period.
11264786|NCT02672423|EG004|Reported Event|Part B 3 x 50 mg (T50)|3 x 50 mg abemaciclib tablets (test formulation[T50]) administered orally on Day 1 of 1 period.
10970045|NCT00908596|BG001|Baseline|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11264787|NCT02672423|EG005|Reported Event|Part C: (T150 Fed, T150 Fasted)|150 mg abemaciclib tablet (test formulation [T150]) with a meal and then without a meal administered orally on Day 1 of 1 period..
11264788|NCT02672423|EG006|Reported Event|Part C: (T150 Fasted, T150 Fed)|150 mg abemaciclib tablet (test formulation [T150]) without a meal and then with a meal administered orally on Day 1 of 1 period.
11264789|NCT02672514|BG000|Baseline|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11286733|NCT02891915|EG001|Reported Event|Standard Course|"Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic~Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.~Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body."
11286734|NCT02892019|BG000|Baseline|Indacaterol Acetate 150 μg o.d.|Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
11264790|NCT02672514|BG001|Baseline|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11264791|NCT02672514|BG002|Baseline|Total|Total of all reporting groups
11264792|NCT02672514|FG000|Participant Flow|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11264793|NCT02672514|FG001|Participant Flow|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11264794|NCT02672514|OG000|Outcome|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
10970046|NCT00908596|BG002|Baseline|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11264795|NCT02672514|OG001|Outcome|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11264796|NCT02672514|EG000|Reported Event|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
11264797|NCT02672514|EG001|Reported Event|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
11264798|NCT02672553|BG000|Baseline|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR
11264799|NCT02672553|BG001|Baseline|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
11264800|NCT02672553|BG002|Baseline|Total|Total of all reporting groups
11264801|NCT02672553|FG000|Participant Flow|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR
11264802|NCT02672553|FG001|Participant Flow|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
11264803|NCT02672553|OG000|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR.
11264804|NCT02672553|OG001|Outcome|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
11264805|NCT02672553|OG000|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR
11264806|NCT02672553|EG000|Reported Event|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR
11264807|NCT02672553|EG001|Reported Event|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
11264808|NCT02672852|BG000|Baseline|Placebo (Part A1)|Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
11264809|NCT02672852|BG001|Baseline|Risankizumab (Part A1)|Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
11264810|NCT02672852|BG002|Baseline|Total|Total of all reporting groups
11264811|NCT02672852|FG000|Participant Flow|Placebo (Part A1)|Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
11264812|NCT02672852|FG001|Participant Flow|Risankizumab (Part A1)|Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
11264813|NCT02672852|FG002|Participant Flow|Placebo/Risankizumab Part A2/Part B|Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B).
11264814|NCT02672852|FG003|Participant Flow|Risankizumab/Risankizumab Part A2|Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg at Weeks 16 (Part A2).
11264815|NCT02672852|FG004|Participant Flow|Risankizumab/Placebo (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
11264816|NCT02672852|FG005|Participant Flow|Risankizumab/Risankizumab (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
11264817|NCT02672852|FG006|Participant Flow|Risankizumab/Risankizumab Part B (Nonresponders)|Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
11264818|NCT02672852|OG000|Outcome|Placebo (Part A1)|Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
11264819|NCT02672852|OG001|Outcome|Risankizumab (Part A1)|Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
11264820|NCT02672852|OG000|Outcome|Risankizumab/Placebo (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
11286735|NCT02892019|BG001|Baseline|Indacaterol Acetate 75 μg o.d.|Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
11286736|NCT02892019|BG002|Baseline|Total|Total of all reporting groups
11264821|NCT02672852|OG001|Outcome|Risankizumab/Risankizumab (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
11264822|NCT02672852|EG000|Reported Event|Placebo (Part A1)|All participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
11264823|NCT02672852|EG001|Reported Event|Risankizumab (Part A1)|All participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
11264824|NCT02672852|EG002|Reported Event|Risankizumab/Placebo (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
11264825|NCT02672852|EG003|Reported Event|Risankizumab/Risankizumab (Part B; Rerandomized Responders)|Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
11264826|NCT02672852|EG004|Reported Event|Any Risankizumab|Participants who received at least one dose of risankizumab during the study.
11264827|NCT02673138|BG000|Baseline|Basal Interruption With or Without Canagliflozin|"Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit~canagliflozin: basal interruption with canagliflozin"
11264828|NCT02673138|FG000|Participant Flow|Basal Interruption With or Without Canagliflozin|"Subjects will undergo basal interruption with or without canagliflozin during an overnight stay on the research unit~canagliflozin: basal interruption with canagliflozin"
11264829|NCT02673138|OG000|Outcome|Basal Interruption|"Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit~basal interruption without canagliflozin: basal interruption"
11264830|NCT02673138|OG001|Outcome|Basal Interruption With Canagliflozin|"Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit~canagliflozin: basal interruption with canagliflozin"
11264831|NCT02673138|EG000|Reported Event|Basal Interruption|"Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit~basal interruption without canagliflozin: basal interruption"
11264832|NCT02673138|EG001|Reported Event|Basal Interruption With Canagliflozin|"Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit~canagliflozin: basal interruption with canagliflozin"
11264833|NCT02673372|BG000|Baseline|Morphine Group|"intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.~Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC."
11264834|NCT02673372|BG001|Baseline|Ketamine Group|"Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)~Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC."
11264835|NCT02673372|BG002|Baseline|Total|Total of all reporting groups
11264836|NCT02673372|FG000|Participant Flow|Morphine Group|"intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.~Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC."
11264837|NCT02673372|FG001|Participant Flow|Ketamine Group|"Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)~Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC."
11264838|NCT02673372|OG000|Outcome|Morphine Group|"intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.~Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC."
11264839|NCT02673372|OG001|Outcome|Ketamine Group|"Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)~Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC."
11264840|NCT02673372|EG000|Reported Event|Morphine Group|"intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.~Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC."
11264841|NCT02673372|EG001|Reported Event|Ketamine Group|"Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)~Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC."
11264842|NCT02673489|BG000|Baseline|Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11264843|NCT02673489|BG001|Baseline|Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11264844|NCT02673489|BG002|Baseline|Total|Total of all reporting groups
11264845|NCT02673489|FG000|Participant Flow|Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11264846|NCT02673489|FG001|Participant Flow|Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11264847|NCT02673489|OG000|Outcome|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11264848|NCT02673489|OG001|Outcome|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11264849|NCT02673489|EG000|Reported Event|Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)|Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
11264850|NCT02673489|EG001|Reported Event|HCV Treatment Naive|HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
11264851|NCT02673489|EG002|Reported Event|HCV Treatment Experienced|HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
11286737|NCT02892019|FG000|Participant Flow|Indacaterol Acetate 150 μg o.d.|Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
11264852|NCT02673515|BG000|Baseline|Alternate Day Fasting|"Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum feed day with a 100% restriction fast day).~Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed."
11264853|NCT02673515|BG001|Baseline|Control Group|participants in the control group should be remaining on their usual diet
11264854|NCT02673515|BG002|Baseline|Total|Total of all reporting groups
11264855|NCT02673515|FG000|Participant Flow|Alternate Day Fasting|"Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum feed day with a 100% restriction fast day).~Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed."
11264856|NCT02673515|FG001|Participant Flow|Control Group|participants in the control group should be remaining on their usual diet
11264857|NCT02673515|OG000|Outcome|Alternate Day Fasting|"Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum feed day with a 100% restriction fast day).~Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed."
11264858|NCT02673515|OG001|Outcome|Control Group|participants of the control group should be remaining on their usual diet
11264859|NCT02673515|EG000|Reported Event|Alternate Day Fasting|"Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum feed day with a 100% restriction fast day).~Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed."
11264860|NCT02673515|EG001|Reported Event|Control Group|Participants in the control group should be remaining their normal diet
11264861|NCT02673541|BG000|Baseline|AXIOS™ Stent|Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist
11264862|NCT02673541|BG001|Baseline|Double Pigtail Stents|"Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.~Double Pigtail Stents: Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity."
11264863|NCT02673541|BG002|Baseline|Total|Total of all reporting groups
11264864|NCT02673541|FG000|Participant Flow|AXIOS™ Stent|Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) through the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist
11264865|NCT02673541|FG001|Participant Flow|Double Pigtail Stents|"Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.~Double Pigtail Stents: Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity."
11264866|NCT02673541|OG000|Outcome|AXIOS™ Stent|Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist.
11264867|NCT02673541|OG001|Outcome|Double Pigtail Stents|"2. Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.~Double Pigtail Stents: Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity."
11264868|NCT02673541|EG000|Reported Event|AXIOS™ Stent|Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist
11264869|NCT02673541|EG001|Reported Event|Double Pigtail Stents|"Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.~Double Pigtail Stents: Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity."
11264870|NCT02673619|BG000|Baseline|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264871|NCT02673619|BG001|Baseline|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264872|NCT02673619|BG002|Baseline|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264873|NCT02673619|BG003|Baseline|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264874|NCT02673619|BG004|Baseline|Total|Total of all reporting groups
11264875|NCT02673619|FG000|Participant Flow|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264876|NCT02673619|FG001|Participant Flow|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264877|NCT02673619|FG002|Participant Flow|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264878|NCT02673619|FG003|Participant Flow|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264879|NCT02673619|OG000|Outcome|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264880|NCT02673619|OG001|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264881|NCT02673619|OG001|Outcome|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264882|NCT02673619|OG002|Outcome|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264883|NCT02673619|OG003|Outcome|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264884|NCT02673619|EG000|Reported Event|Higher Dose Cohort (UMEC 1.85 Percent)|Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264885|NCT02673619|EG001|Reported Event|Higher Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264886|NCT02673619|EG002|Reported Event|Lower Dose Cohort (UMEC 1.15 Percent)|Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264887|NCT02673619|EG003|Reported Event|Lower Dose Cohort (Vehicle)|Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
11264888|NCT02673918|BG000|Baseline|Part 1: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264889|NCT02673918|BG001|Baseline|Part 2: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264890|NCT02673918|BG002|Baseline|Total|Total of all reporting groups
11286738|NCT02892019|FG001|Participant Flow|Indacaterol Acetate 75 μg o.d.|Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
11286739|NCT02892019|OG000|Outcome|Indacaterol Acetate 150 μg o.d.|Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
11286740|NCT02892019|OG001|Outcome|Indacaterol Acetate 75 μg o.d.|Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
11264891|NCT02673918|FG000|Participant Flow|Part 1: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264892|NCT02673918|FG001|Participant Flow|Part 2: Home-based Rehabilitation|"Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264893|NCT02673918|OG000|Outcome|Part 1: Home-based Rehabilitation|"Participants in part 1 and part 2 will receive home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264894|NCT02673918|OG001|Outcome|Part 2: Home-based Rehabilitation|"Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264895|NCT02673918|OG000|Outcome|Part 1: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264896|NCT02673918|OG000|Outcome|Part 1: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264897|NCT02673918|EG000|Reported Event|Part 1: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11286741|NCT02892019|EG000|Reported Event|QAB149 150 ug OD|QAB149 150 ug OD
11286742|NCT02892019|EG001|Reported Event|QAB149 75 ug OD|QAB149 75 ug OD
11286743|NCT02892110|BG000|Baseline|Varenicline|"2 mg daily~Varenicline: 2 mg daily"
11286744|NCT02892110|BG001|Baseline|Placebo|"2 mg daily~Placebo: 2 mg daily"
11286745|NCT02892110|BG002|Baseline|Total|Total of all reporting groups
11286746|NCT02892110|FG000|Participant Flow|Varenicline|"2 mg daily~Varenicline: 2 mg daily"
11286747|NCT02892110|FG001|Participant Flow|Placebo|"2 mg daily~Placebo: 2 mg daily"
11286748|NCT02892110|OG000|Outcome|Varenicline|"2 mg daily~Varenicline: 2 mg daily"
11264898|NCT02673918|EG001|Reported Event|Part 2: Home-based Rehabilitation|"Home-based upper-body rehabilitation with online support~Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.~On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes."
11264899|NCT02673944|BG000|Baseline|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11264900|NCT02673944|FG000|Participant Flow|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11264901|NCT02673944|OG000|Outcome|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11264902|NCT02673944|OG001|Outcome|Standard Urodynamic Analyzer|Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
11264903|NCT02673944|EG000|Reported Event|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
11264904|NCT02674334|BG000|Baseline|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to NIRS data and treated participants per standard of care.
11264905|NCT02674334|BG001|Baseline|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based NIRS monitoring and per standard of care.
11264906|NCT02674334|BG002|Baseline|Total|Total of all reporting groups
11264907|NCT02674334|FG000|Participant Flow|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.
11264908|NCT02674334|FG001|Participant Flow|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.
11264909|NCT02674334|OG000|Outcome|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS monitoring and treated participants per standard of care based on MAP.
11264910|NCT02674334|OG001|Outcome|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP.
11264911|NCT02674334|EG000|Reported Event|NIRS Monitored Not Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment.
11264912|NCT02674334|EG001|Reported Event|NIRS Monitored and Treated|Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care.
10970047|NCT00908596|BG003|Baseline|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
10970048|NCT00908596|BG004|Baseline|Total|Total of all reporting groups
11264913|NCT02674386|BG000|Baseline|Placebo|Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
11264914|NCT02674386|BG001|Baseline|Tanezumab Combined|Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264915|NCT02674386|BG002|Baseline|NSAID|Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264916|NCT02674386|BG003|Baseline|Total|Total of all reporting groups
11264917|NCT02674386|FG000|Participant Flow|Placebo|Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
11286749|NCT02892110|OG001|Outcome|Placebo|"2 mg daily~Placebo: 2 mg daily"
11286750|NCT02892110|EG000|Reported Event|Varenicline|"2 mg daily~Varenicline: 2 mg daily"
11286751|NCT02892110|EG001|Reported Event|Placebo|"2 mg daily~Placebo: 2 mg daily"
11264918|NCT02674386|FG001|Participant Flow|Tanezumab Combined|Participants who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264919|NCT02674386|FG002|Participant Flow|NSAID|Participants who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264920|NCT02674386|OG000|Outcome|Placebo|Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
11264921|NCT02674386|OG001|Outcome|Tanezumab Combined|Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264922|NCT02674386|OG002|Outcome|NSAID|Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264923|NCT02674386|OG003|Outcome|All Participants|All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
11264924|NCT02674386|EG000|Reported Event|Placebo|Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
11264925|NCT02674386|EG001|Reported Event|Tanezumab 2.5 mg|Participants who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264926|NCT02674386|EG002|Reported Event|Tanezumab 2.5/5 mg|Participants who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264927|NCT02674386|EG003|Reported Event|Tanezumab 5 mg|Participants who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264928|NCT02674386|EG004|Reported Event|Tanezumab Combined|Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264929|NCT02674386|EG005|Reported Event|NSAID|Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
11264930|NCT02674386|EG006|Reported Event|All Participants|All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
11264931|NCT02674399|BG000|Baseline|JointStem|"autologous adipose tissue derived mesenchymal stem cells (AdMSC)~JointStem"
11264932|NCT02674399|BG001|Baseline|Synvisc-One|"hyaluronic acid~Synvisc-One"
11264933|NCT02674399|BG002|Baseline|Total|Total of all reporting groups
11264934|NCT02674399|FG000|Participant Flow|JointStem|JointStem : autologous adipose tissue derived mesenchymal stem cells (AdMSC) 1x10e8 cells At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
11264935|NCT02674399|FG001|Participant Flow|Synvisc-One|hyaluronic acid At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
11264936|NCT02674399|OG000|Outcome|JointStem|"autologous adipose tissue derived mesenchymal stem cells (AdMSC)~JointStem"
11264937|NCT02674399|OG001|Outcome|Synvisc-One|"hyaluronic acid~Synvisc-One"
11264938|NCT02674399|EG000|Reported Event|JointStem|autologous adipose tissue derived mesenchymal stem cells (AdMSC)
11264939|NCT02674399|EG001|Reported Event|Synvisc-One|hyaluronic acid
11264940|NCT02674412|BG000|Baseline|All Study Participants|All participants who enrolled in and completed the study.
11264941|NCT02674412|FG000|Participant Flow|Buspirone Then Placebo|Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
11264942|NCT02674412|FG001|Participant Flow|Placebo Then Buspirone|Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
11264943|NCT02674412|OG000|Outcome|Buspirone|All participants in the study, while taking Buspirone
11264944|NCT02674412|OG001|Outcome|Placebo|All participants on the study, while taking placebo.
11264945|NCT02674412|OG001|Outcome|Placebo|All participants in the study, while taking placebo
11264946|NCT02674412|EG000|Reported Event|Buspirone|"Buspirone 10 mg PO TID~Buspirone"
11264947|NCT02674412|EG001|Reported Event|Placebo|"Placebo Tablet TID~Placebo: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic"
11264948|NCT02674477|BG000|Baseline|Therapeutic Education System (TES)|"Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well.~Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material."
11264949|NCT02674477|BG001|Baseline|Treatment as Usual (TAU)|"Participants will have the typical treatment during and after their hospitalizations, without additional intervention.~Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization."
11264950|NCT02674477|BG002|Baseline|Total|Total of all reporting groups
11264951|NCT02674477|FG000|Participant Flow|Therapeutic Education System (TES)|"Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well.~Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material."
11264952|NCT02674477|FG001|Participant Flow|Treatment as Usual (TAU)|"Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health. There will be no change to the routine care (treatment at usual [TAU]) provided to patients on the service.~Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization."
11264953|NCT02674477|OG000|Outcome|Therapeutic Education System (TES)|"Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well.~Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material."
11264954|NCT02674477|OG001|Outcome|Treatment as Usual (TAU)|"Participants will have the typical treatment during and after their hospitalizations, without additional intervention.~Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization."
11264955|NCT02674477|EG000|Reported Event|Therapeutic Education System (TES)|"Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well.~Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material."
10970049|NCT00908596|FG000|Participant Flow|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11264956|NCT02674477|EG001|Reported Event|Treatment as Usual (TAU)|"Participants will have the typical treatment during and after their hospitalizations, without additional intervention.~Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization."
11286752|NCT02892344|BG000|Baseline|QMF149 150/80 μg|QMF149 150/80 microgram o.d. delivered via Concept1
11286753|NCT02892344|BG001|Baseline|MF 200 µg|MF 200 microgram o.d. delivered via Twisthaler®
11264957|NCT02674568|BG000|Baseline|Rovalpituzumab Tesirine|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264958|NCT02674568|FG000|Participant Flow|Rovalpituzumab Tesirine|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264959|NCT02674568|OG000|Outcome|Rovalpituzumab Tesirine: DLL3 High|'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264960|NCT02674568|OG001|Outcome|Rovalpituzumab Tesirine: DLL3 Positive|'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264961|NCT02674568|OG000|Outcome|Rovalpituzumab Tesirine: Initial Treatment Period|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles.
11264962|NCT02674568|OG001|Outcome|Rovalpituzumab Tesirine: Re-Treatment 1|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 1
11264963|NCT02674568|OG002|Outcome|Rovalpituzumab Tesirine: Re-Treatment 2|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 2
11264964|NCT02674568|OG000|Outcome|Rovalpituzumab Tesirine|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264965|NCT02674568|EG000|Reported Event|Rovalpituzumab Tesirine|0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
11264966|NCT02674633|BG000|Baseline|AKL-T01 (EVO Multi)|"AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.~AKL-T01: Videogame-like digital therapy"
10970050|NCT00908596|FG001|Participant Flow|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11264967|NCT02674633|BG001|Baseline|AKL-T09 (EVO Words)|"AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.~AKL-T09: Videogame-like digital therapy"
11264968|NCT02674633|BG002|Baseline|Total|Total of all reporting groups
11264969|NCT02674633|FG000|Participant Flow|AKL-T01 (EVO Multi)|"AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.~AKL-T01: Videogame-like digital therapy"
11264970|NCT02674633|FG001|Participant Flow|AKL-T09 (EVO Words)|"AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.~AKL-T09: Videogame-like digital therapy"
11264971|NCT02674633|OG000|Outcome|AKL-T01 (EVO Multi)|"AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.~AKL-T01: Videogame-like digital therapy"
11264972|NCT02674633|OG001|Outcome|AKL-T09 (EVO Words)|"AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.~AKL-T09: Videogame-like digital therapy"
11264973|NCT02674633|EG000|Reported Event|AKL-T01 (EVO Multi)|"AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.~AKL-T01: Videogame-like digital therapy"
11286754|NCT02892344|BG002|Baseline|Total|Total of all reporting groups
11286755|NCT02892344|FG000|Participant Flow|QMF149 150/80 μg|QMF149 150/80 microgram o.d. delivered via Concept1
11264974|NCT02674633|EG001|Reported Event|AKL-T09 (EVO Words)|"AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.~AKL-T09: Videogame-like digital therapy"
11264975|NCT02674659|BG000|Baseline|Control Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264976|NCT02674659|BG001|Baseline|Intervention Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)~resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264977|NCT02674659|BG002|Baseline|Total|Total of all reporting groups
11264978|NCT02674659|FG000|Participant Flow|Control Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264979|NCT02674659|FG001|Participant Flow|Intervention Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)~resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264980|NCT02674659|OG000|Outcome|Control Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264981|NCT02674659|OG001|Outcome|Intervention Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)~resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264982|NCT02674659|EG000|Reported Event|Control Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264983|NCT02674659|EG001|Reported Event|Intervention Group|"Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)~resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.~aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)"
11264984|NCT02674685|BG000|Baseline|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
11264985|NCT02674685|FG000|Participant Flow|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
11264986|NCT02674685|OG000|Outcome|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
11264987|NCT02674685|EG000|Reported Event|VFEND (Voriconazole)|Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
11264988|NCT02674854|BG000|Baseline|PG324 Ophthalmic Solution|1 drop daily in the evening (PM) in both eyes (OU)
11264989|NCT02674854|BG001|Baseline|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop daily in the evening (PM) in both eyes (OU)
11264990|NCT02674854|BG002|Baseline|Latanoprost Ophthalmic Solution 0.005%|1 drop daily in the evening (PM) in both eyes (OU)
11264991|NCT02674854|BG003|Baseline|Total|Total of all reporting groups
11264992|NCT02674854|FG000|Participant Flow|PG324 Ophthalmic Solution 0.02%/0.005%|1 drop daily in the evening (PM) in both eyes (OU)
11264993|NCT02674854|FG001|Participant Flow|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop daily in the evening (PM) in both eyes (OU)
11264994|NCT02674854|FG002|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|1 drop daily in the evening (PM) in both eyes (OU)
11264995|NCT02674854|OG000|Outcome|PG324 Ophthalmic Solution|1 drop daily in the evening (PM) in both eyes (OU)
11264996|NCT02674854|OG001|Outcome|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop daily in the evening (PM) in both eyes (OU)
11264997|NCT02674854|OG002|Outcome|Latanoprost Ophthalmic Solution 0.005%|1 drop daily in the evening (PM) in both eyes (OU)
11264998|NCT02674854|EG000|Reported Event|PG324 Ophthalmic Solution|1 drop daily in the evening (PM) in both eyes (OU)
11264999|NCT02674854|EG001|Reported Event|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop daily in the evening (PM) in both eyes (OU)
11265000|NCT02674854|EG002|Reported Event|Latanoprost Ophthalmic Solution 0.005%|1 drop daily in the evening (PM) in both eyes (OU)
11265001|NCT02675075|BG000|Baseline|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria. Veterans were at least 18 years old, and were diagnosed with ALS, and followed at the James A Haley VA Hospital
11265002|NCT02675075|BG001|Baseline|Healthy Controls|Healthy Controls were recruited to complete a one time vocal recording of the TIMIT and Ba repetition voice recordings.
11265003|NCT02675075|BG002|Baseline|Total|Total of all reporting groups
11265004|NCT02675075|FG000|Participant Flow|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
11265005|NCT02675075|FG001|Participant Flow|Healthy Controls|Anonymous Controls who were not diagnosed with any nervous system diseases.
11265006|NCT02675075|OG000|Outcome|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
11265007|NCT02675075|OG001|Outcome|Healthy Controls|Anonymous Controls who were not diagnosed with any nervous system diseases.
11265008|NCT02675075|OG000|Outcome|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria. Veterans were at least 18 years old, and were diagnosed with ALS, and followed at the James A Haley VA Hospital.
11265009|NCT02675075|OG000|Outcome|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria. Veterans were at least 18 years old, and were diagnosed with ALS, and followed at the James A Haley VA Hospital
11265010|NCT02675075|EG000|Reported Event|Veterans With ALS|This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
11265011|NCT02675075|EG001|Reported Event|Healthy Controls|Healthy Controls were enrolled for a one time vocal recording. There was no follow-up visits for healthy controls.
11265012|NCT02675517|BG000|Baseline|Spiolto Respimat|COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11265013|NCT02675517|FG000|Participant Flow|Spiolto Respimat|COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11265014|NCT02675517|OG000|Outcome|Spiolto Respimat|COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11265015|NCT02675517|EG000|Reported Event|Spiolto Respimat|COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11265016|NCT02675543|BG000|Baseline|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11265017|NCT02675543|BG001|Baseline|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11265018|NCT02675543|BG002|Baseline|Total|Total of all reporting groups
11265019|NCT02675543|FG000|Participant Flow|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11265020|NCT02675543|FG001|Participant Flow|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11265021|NCT02675543|OG000|Outcome|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11265022|NCT02675543|OG001|Outcome|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11265023|NCT02675543|EG000|Reported Event|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
11265024|NCT02675543|EG001|Reported Event|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
11265025|NCT02675634|BG000|Baseline|The Study Population|This consists of all participants who were enrolled in the study
11265026|NCT02675634|FG000|Participant Flow|Test A, Test B, Subjects Own Product|"The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
10970051|NCT00908596|FG002|Participant Flow|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265027|NCT02675634|FG001|Participant Flow|Test A, Subjects Own Product, Test B|"The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11286756|NCT02892344|FG001|Participant Flow|MF 200 µg|MF 200 microgram o.d. delivered via Twisthaler®
11286757|NCT02892344|OG000|Outcome|QMF149 150/80 μg|QMF149 150/80 microgram o.d. delivered via Concept1
11286758|NCT02892344|OG001|Outcome|MF 200 µg|MF 200 microgram o.d. delivered via Twisthaler®
11286759|NCT02892344|EG000|Reported Event|QMF149 150/80|QMF149 150/80 microgram o.d. delivered via Concept1
11265028|NCT02675634|FG002|Participant Flow|Test B, Test A, Subjects Own Product|"The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11265029|NCT02675634|FG003|Participant Flow|Test B, Subjects Own Product, Test A|"The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11265030|NCT02675634|FG004|Participant Flow|Subjects Own Product, Test A, Test B|"The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11265031|NCT02675634|FG005|Participant Flow|Subjects Own Product, Test B, Test A|"The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A~Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S~Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S~Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group."
11265032|NCT02675634|OG000|Outcome|Test A|This is the result from all subjects evaluating Test A
11265033|NCT02675634|OG001|Outcome|Test B|This is the results from all the subjects evaluating Test B
11265034|NCT02675634|OG002|Outcome|Own Product|this is the result from all the subjects evaluating Own product.
11265035|NCT02675634|EG000|Reported Event|Test A|This is the result from all subjects evaluating Test A
11265036|NCT02675634|EG001|Reported Event|Test B|This is the results from all the subjects evaluating Test B
11265037|NCT02675634|EG002|Reported Event|Own Product|this is the result from all the subjects evaluating Own product.
11265038|NCT02675764|BG000|Baseline|Experimental|"The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.~Vibration: peripheral vibration at the wrist skin at an imperceptible level~therapy: standardized hand therapy program"
11265039|NCT02675764|BG001|Baseline|Placebo|"The control group will wear the vibration device with no vibration.~Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.~Placebo (for vibration): No peripheral vibration at the wrist skin~therapy: standardized hand therapy program"
11265040|NCT02675764|BG002|Baseline|Total|Total of all reporting groups
11265041|NCT02675764|FG000|Participant Flow|Experimental (Therapy + Stimulation)|"The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.~Vibration: peripheral vibration at the wrist skin at an imperceptible level~therapy: standardized hand therapy program"
11265042|NCT02675764|FG001|Participant Flow|Placebo (Therapy + Stimulation Placebo)|"The control group wears the vibration device with no vibration during therapy.~Placebo (for vibration): No peripheral vibration at the wrist skin~therapy: standardized hand therapy program"
11265043|NCT02675764|OG000|Outcome|Experimental (Therapy + Stimulation)|"The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.~Vibration: peripheral vibration at the wrist skin at an imperceptible level~therapy: standardized hand therapy program"
11265044|NCT02675764|OG001|Outcome|Placebo (Therapy + Stimulation Placebo)|"The control group wears the vibration device with no vibration.~Placebo (for vibration): No peripheral vibration at the wrist skin~therapy: standardized hand therapy program"
11265045|NCT02675764|EG000|Reported Event|Experimental|"The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.~Vibration: peripheral vibration at the wrist skin at an imperceptible level~therapy: standardized hand therapy program"
11265046|NCT02675764|EG001|Reported Event|Placebo|"The control group will wear the vibration device with no vibration.~Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.~Placebo (for vibration): No peripheral vibration at the wrist skin~therapy: standardized hand therapy program"
11265047|NCT02675907|BG000|Baseline|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265048|NCT02675907|BG001|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265049|NCT02675907|BG002|Baseline|Total|Total of all reporting groups
11265050|NCT02675907|FG000|Participant Flow|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265051|NCT02675907|FG001|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
10848141|NCT00288704|FG002|Participant Flow|Open-Label Extension (OLE) Rilonacept 160 mg|"After week 24 of study, all subjects received weekly injections of rilonacept 160 mg until the end of the study. This was not part of the double blind (Part A) or randomized withdrawal (Part B) portion of the results. Pediatric subjects received rilonacept dosed 2.2 mg/kg weekly up to 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week."
10848142|NCT00288704|OG000|Outcome|Placebo|
10848143|NCT00288704|OG001|Outcome|Rilonacept 160 mg|
10848144|NCT00288704|OG000|Outcome|Rilonacept 160 mg|
10848145|NCT00288704|EG000|Reported Event|Rilonacept 160 mg|
10848146|NCT00288704|EG001|Reported Event|Placebo|
11265052|NCT02675907|OG000|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265053|NCT02675907|OG001|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265054|NCT02675907|EG000|Reported Event|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265055|NCT02675907|EG001|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265056|NCT02675998|BG000|Baseline|3mg BID|Tenapanor, 3mg BID (6mg total)
11265057|NCT02675998|BG001|Baseline|10mg BID|Tenapanor, 10mg BID (20mg total)
11265058|NCT02675998|BG002|Baseline|Dose Titration|Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question
11265059|NCT02675998|BG003|Baseline|Placebo|"Placebo~Placebo"
11265060|NCT02675998|BG004|Baseline|Total|Total of all reporting groups
11265061|NCT02675998|FG000|Participant Flow|3mg BID|"Tenapanor, 3mg BID (6mg total)~Tenapanor"
11265062|NCT02675998|FG001|Participant Flow|10mg BID|"Tenapanor, 10mg BID (20mg total)~Tenapanor"
10970052|NCT00908596|FG003|Participant Flow|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265063|NCT02675998|FG002|Participant Flow|30 mg Dose Titration|"Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question~Tenapanor"
11265064|NCT02675998|FG003|Participant Flow|Randomized Withdrawal Period Placebo|These were participants re-randomized to placebo during the 4-week withdrawal period.
11265065|NCT02675998|OG000|Outcome|3mg BID|"Tenapanor, 3mg BID (6mg total)~Tenapanor"
11265066|NCT02675998|OG001|Outcome|10mg BID|"Tenapanor, 10mg BID (20mg total)~Tenapanor"
11265067|NCT02675998|OG002|Outcome|30 mg Dose Titration|"Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question~Tenapanor"
11265068|NCT02675998|OG003|Outcome|Placebo|"Placebo~Placebo"
11265069|NCT02675998|EG000|Reported Event|3mg BID|Tenapanor, 3mg BID (6mg total)
11265070|NCT02675998|EG001|Reported Event|10mg BID|Tenapanor, 10mg BID (20mg total)
11265071|NCT02675998|EG002|Reported Event|30 mg Dose Titration|Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question
11265072|NCT02675998|EG003|Reported Event|Randomized Withdrawal Period Placebo|The 164 patients that ended the 8 week treatment period were re-randomized 1:1 to stay on tenapanor or receive placebo. The patients in this group were re-randomized to receive placebo for the last 4 weeks of the study
11265073|NCT02676375|BG000|Baseline|Standard Monotherapy|"Treatment as usual starting with one smoking cessation medication plus group therapy.~Monotherapy"
11265074|NCT02676375|BG001|Baseline|Combination Extended Treatment|"Extended treatment with multiple standard medications plus group therapy.~Combination Bupropion + NRTs~Extended Treatment"
11265075|NCT02676375|BG002|Baseline|Combination Extended Treatment + Home Visits/Calls|"Extended treatment with multiple standard medications plus group therapy plus home visits.~Combination Bupropion + NRTs~Extended Treatment~Home Visits & Calls"
11265076|NCT02676375|BG003|Baseline|Total|Total of all reporting groups
11265077|NCT02676375|FG000|Participant Flow|Standard Monotherapy|"Treatment as usual starting with one smoking cessation medication plus group therapy.~Monotherapy"
11265078|NCT02676375|FG001|Participant Flow|Combination Extended Treatment|"Extended treatment with multiple standard medications plus group therapy.~Combination Bupropion + NRTs~Extended Treatment"
11265079|NCT02676375|FG002|Participant Flow|Combination Extended Treatment + Home Visits/Calls|"Extended treatment with multiple standard medications plus group therapy plus home visits.~Combination Bupropion + NRTs~Extended Treatment~Home Visits & Calls"
11265080|NCT02676375|OG000|Outcome|Standard Monotherapy|"Treatment as usual starting with one smoking cessation medication plus group therapy.~Monotherapy"
11265081|NCT02676375|OG001|Outcome|Combination Extended Treatment|"Extended treatment with multiple standard medications plus group therapy.~Combination Bupropion + NRTs~Extended Treatment"
11265082|NCT02676375|OG002|Outcome|Combination Extended Treatment + Home Visits/Calls|"Extended treatment with multiple standard medications plus group therapy plus home visits.~Combination Bupropion + NRTs~Extended Treatment~Home Visits & Calls"
11265083|NCT02676375|EG000|Reported Event|Standard Monotherapy|"Treatment as usual starting with one smoking cessation medication plus group therapy.~Monotherapy"
11265084|NCT02676375|EG001|Reported Event|Combination Extended Treatment|"Extended treatment with multiple standard medications plus group therapy.~Combination Bupropion + NRTs~Extended Treatment"
11265085|NCT02676375|EG002|Reported Event|Combination Extended Treatment + Home Visits/Calls|"Extended treatment with multiple standard medications plus group therapy plus home visits.~Combination Bupropion + NRTs~Extended Treatment~Home Visits & Calls"
11265086|NCT02676466|BG000|Baseline|Fish Oil Active|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day."
11265087|NCT02676466|BG001|Baseline|Fish Oil Placebo|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil."
11286760|NCT02892344|EG001|Reported Event|MF 200|MF 200 microgram o.d. delivered via Twisthaler®
11286761|NCT02892409|BG000|Baseline|Clarithromycin + Amoxicillin + Bismuth + TAK-438|Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
11265088|NCT02676466|BG002|Baseline|Losartan Active|"This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day."
11265089|NCT02676466|BG003|Baseline|Losartan Placebo|"This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11265090|NCT02676466|BG004|Baseline|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin"
11265091|NCT02676466|BG005|Baseline|Fish Oil Active + Losartan Placebo|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.~In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.~Cellulose Based (Losartan Placeb"
11265092|NCT02676466|BG006|Baseline|Fish Oil Placebo + Losartan Active|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure"
11265093|NCT02676466|BG007|Baseline|Fish Oil Placebo + Losartan Placebo|"This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11265094|NCT02676466|BG008|Baseline|Total|Total of all reporting groups
11265095|NCT02676466|FG000|Participant Flow|Fish Oil Active|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day."
11265096|NCT02676466|FG001|Participant Flow|Fish Oil Placebo|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil."
11286762|NCT02892409|BG001|Baseline|Clarithromycin + Amoxicillin + Bismuth + Lansoprazole|Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
11286763|NCT02892409|BG002|Baseline|Total|Total of all reporting groups
11286764|NCT02892409|FG000|Participant Flow|Clarithromycin + Amoxicillin + Bismuth + TAK-438|Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
10848147|NCT00288860|BG000|Baseline|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
10848148|NCT00288860|BG001|Baseline|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
11265097|NCT02676466|FG002|Participant Flow|Losartan Active|"This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day."
11265098|NCT02676466|FG003|Participant Flow|Losartan Placebo|"This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11265099|NCT02676466|FG004|Participant Flow|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months."
11265100|NCT02676466|FG005|Participant Flow|Fish Oil Active + Losartan Placebo|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan."
11265101|NCT02676466|FG006|Participant Flow|Fish Oil Placebo + Losartan Active|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months."
11265102|NCT02676466|FG007|Participant Flow|Fish Oil Placebo + Losartan Placebo|This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
11265103|NCT02676466|OG000|Outcome|Fish Oil Active|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day."
11265104|NCT02676466|OG001|Outcome|Fish Oil Placebo|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil."
11265105|NCT02676466|OG002|Outcome|Losartan Active|"This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day."
10848149|NCT00288860|BG002|Baseline|Total|Total of all reporting groups
11265106|NCT02676466|OG003|Outcome|Losartan Placebo|"This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11286765|NCT02892409|FG001|Participant Flow|Clarithromycin + Amoxicillin + Bismuth + Lansoprazole|Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
11286766|NCT02892409|OG000|Outcome|Clarithromycin + Amoxicillin + Bismuth + TAK-438|Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
11286767|NCT02892409|OG001|Outcome|Clarithromycin + Amoxicillin + Bismuth + Lansoprazole|Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
11265107|NCT02676466|OG004|Outcome|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin"
11265108|NCT02676466|OG005|Outcome|Fish Oil Active + Losartan Placebo|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.~In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.~Cellulose Based (Losartan Placeb"
11265109|NCT02676466|OG006|Outcome|Fish Oil Placebo + Losartan Active|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure"
11265110|NCT02676466|OG007|Outcome|Fish Oil Placebo + Losartan Placebo|"This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11265111|NCT02676466|OG004|Outcome|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams/ day or be increased to 100 milligrams per day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin"
11265112|NCT02676466|OG005|Outcome|Fish Oil Active + Losartan Placebo|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams/day or be increased to 2.8 grams per day for the remaining six month.~In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.~Cellulose Based (Losartan Placeb"
11265113|NCT02676466|OG004|Outcome|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin"
11286768|NCT02892409|EG000|Reported Event|Clarithromycin + Amoxicillin + Bismuth + TAK-438|Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
10848150|NCT00288860|FG000|Participant Flow|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
11265114|NCT02676466|OG006|Outcome|Fish Oil Placebo + Losartan Active|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure"
11265115|NCT02676466|EG000|Reported Event|Fish Oil Active|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day."
11265116|NCT02676466|EG001|Reported Event|Fish Oil Placebo|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil."
11265117|NCT02676466|EG002|Reported Event|Losartan Active|"This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day."
11265118|NCT02676466|EG003|Reported Event|Losartan Placebo|"This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.~Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules."
11265119|NCT02676466|EG004|Reported Event|Fish Oil Active + Losartan Active|"This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.~Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months."
11265120|NCT02676466|EG005|Reported Event|Fish Oil Active + Losartan Placebo|"This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.~In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan."
11265121|NCT02676466|EG006|Reported Event|Fish Oil Placebo + Losartan Active|"This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.~In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months."
11265122|NCT02676466|EG007|Reported Event|Fish Oil Placebo + Losartan Placebo|This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
11265123|NCT02676778|BG000|Baseline|PTCL: E7777 9 mcg/kg/Day|Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
10848151|NCT00288860|FG001|Participant Flow|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
11265124|NCT02676778|BG001|Baseline|CTCL: E7777 9 mcg/kg/Day|Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265125|NCT02676778|BG002|Baseline|Other: E7777 9 mcg/kg/Day|Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265126|NCT02676778|BG003|Baseline|Total|Total of all reporting groups
11265127|NCT02676778|FG000|Participant Flow|PTCL: E7777 9 mcg/kg/Day|Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) received E7777 9 microgram per kilogram per day (mcg/kg/day) as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length equal to [=] 3 weeks).
11265128|NCT02676778|FG001|Participant Flow|CTCL: E7777 9 mcg/kg/Day|Participants with cutaneous T-cell lymphoma (CTCL) received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265129|NCT02676778|FG002|Participant Flow|Other: E7777 9 mcg/kg/Day|Participant with extranodal natural killer (NK)/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265130|NCT02676778|OG000|Outcome|PTCL: E7777 9 mcg/kg/Day|Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265131|NCT02676778|OG001|Outcome|CTCL: E7777 9 mcg/kg/Day|Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265132|NCT02676778|OG002|Outcome|Other: E7777 9 mcg/kg/Day|Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265133|NCT02676778|OG000|Outcome|PTCL and CTCL Participants: E7777 9 mcg/kg/Day|Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265134|NCT02676778|EG000|Reported Event|PTCL: E7777 9 mcg/kg/Day|Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265135|NCT02676778|EG001|Reported Event|CTCL: E7777 9 mcg/kg/Day|Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265136|NCT02676778|EG002|Reported Event|Other: E7777 9 mcg/kg/Day|Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
11265137|NCT02676843|BG000|Baseline|18F-AV-1451|"Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.~18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan."
11265138|NCT02676843|FG000|Participant Flow|18F-AV-1451|"Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.~18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan."
11265139|NCT02676843|OG000|Outcome|18F-AV-1451 - Non-carriers|"Subjects who are microtubule associated protein tau (MAPT) family non-carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.~18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan."
11265140|NCT02676843|OG001|Outcome|18F-AV-1451 - Carriers|"Subjects who are MAPT family carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.~18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan."
11265141|NCT02676843|EG000|Reported Event|18F-AV-1451|"Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.~18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan."
11265142|NCT02676882|BG000|Baseline|"Group 1 - Relapse-Prevention Group (Well Group)"|"Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of < 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11265143|NCT02676882|BG001|Baseline|"Group 2 - Treatment Group (Depressed Group)"|"Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of > 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11265144|NCT02676882|BG002|Baseline|Total|Total of all reporting groups
11265145|NCT02676882|FG000|Participant Flow|"Group 1 - Relapse-Prevention Group (Well Group)"|"Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of < 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11337535|NCT03586830|EG001|Reported Event|JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11265146|NCT02676882|FG001|Participant Flow|"Group 2 - Treatment Group (Depressed Group)"|"Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of > 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11265147|NCT02676882|OG000|Outcome|"Group 1 - Relapse-Prevention Group (Well Group)"|"Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of < 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11265148|NCT02676882|OG000|Outcome|"Group 2 - Treatment Group (Depressed Group)"|"Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of > 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.~Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study"
11265149|NCT02676882|EG000|Reported Event|"Group 1 - Relapse Prevention Group (Well Group)"|"Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.~Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from Major Depressive Disorder (MDD) as defined by a baseline score of </=10 on the Montgomery-Åsberg Depression Rating Scale (MADRS), have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of a major depressive episode (MDE) as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses."
11265150|NCT02676882|EG001|Reported Event|"Group 2 - Treatment Group (Depressed Group)"|"Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.~Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of >/=15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated."
11265151|NCT02676895|BG000|Baseline|1790GAHB 25 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
11265152|NCT02676895|BG001|Baseline|1790GAHB 100 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
11265153|NCT02676895|BG002|Baseline|Control Group|Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
11265154|NCT02676895|BG003|Baseline|Total|Total of all reporting groups
11265155|NCT02676895|FG000|Participant Flow|1790GAHB 25 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
11265156|NCT02676895|FG001|Participant Flow|1790GAHB 100 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
11265157|NCT02676895|FG002|Participant Flow|Control Group|Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
11265158|NCT02676895|OG000|Outcome|1790GAHB 25 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
11265159|NCT02676895|OG001|Outcome|1790GAHB 100 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
11265160|NCT02676895|OG002|Outcome|Control Group|Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
11265161|NCT02676895|OG000|Outcome|1790GAHB 25 μg Group|Subjects who received 2 injections 1790GAHB vaccine containing 25 μg of S. sonnei
11265162|NCT02676895|EG000|Reported Event|1790GAHB 25 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
11265163|NCT02676895|EG001|Reported Event|1790GAHB 100 μg Group|Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
11265164|NCT02676895|EG002|Reported Event|Control Group|Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
11265165|NCT02677116|BG000|Baseline|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265166|NCT02677116|BG001|Baseline|Olaratumab + Doxorubicin (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265167|NCT02677116|BG002|Baseline|Olaratumab + Ifosfamide (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265168|NCT02677116|BG003|Baseline|Olaratumab + Vincristine + Irinotecan (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265169|NCT02677116|BG004|Baseline|Olaratumab + Doxorubicin (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265170|NCT02677116|BG005|Baseline|Olaratumab + Ifosfamide (Part B)|"Cycle1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265171|NCT02677116|BG006|Baseline|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265172|NCT02677116|BG007|Baseline|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265173|NCT02677116|BG008|Baseline|Olaratumab + Doxorubicin (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265174|NCT02677116|BG009|Baseline|Total|Total of all reporting groups
11265175|NCT02677116|FG000|Participant Flow|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265176|NCT02677116|FG001|Participant Flow|Olaratumab + Doxorubicin (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. . Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265177|NCT02677116|FG002|Participant Flow|Olaratumab + Ifosfamide (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265178|NCT02677116|FG003|Participant Flow|Olaratumab + Vincristine + Irinotecan (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265179|NCT02677116|FG004|Participant Flow|Olaratumab + Doxorubicin (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265180|NCT02677116|FG005|Participant Flow|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265181|NCT02677116|FG006|Participant Flow|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265182|NCT02677116|FG007|Participant Flow|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265183|NCT02677116|FG008|Participant Flow|Olaratumab + Doxorubicin (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265184|NCT02677116|OG000|Outcome|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265185|NCT02677116|OG001|Outcome|Olaratumab + Ifosfamide (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265186|NCT02677116|OG002|Outcome|Olaratumab + Doxorubicin (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8).~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265187|NCT02677116|OG003|Outcome|Olaratumab + Vincristine + Irinotecan (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265188|NCT02677116|OG004|Outcome|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg alone (administered IV on Days 1 and 8).~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265189|NCT02677116|OG005|Outcome|Olaratumab + Doxorubicin (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265190|NCT02677116|OG006|Outcome|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265191|NCT02677116|OG007|Outcome|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265192|NCT02677116|OG008|Outcome|Olaratumab + Doxorubicin (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265193|NCT02677116|OG000|Outcome|Olaratumab Alone (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~All cycles are 21 days."
11265194|NCT02677116|OG001|Outcome|Olaratumab + Doxorubicin (Part A)|"Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265195|NCT02677116|OG002|Outcome|Olaratumab + Ifosfamide (Part A)|"Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265196|NCT02677116|OG003|Outcome|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265197|NCT02677116|OG000|Outcome|Olaratumab Alone (Part B)|"Cycle 1: Olaratumab 20-mg/kg was administered alone IV on Days 1 and 8.~All cycles are 21 days."
11265198|NCT02677116|OG001|Outcome|Olaratumab + Doxorubicin (Part B)|"Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265199|NCT02677116|OG002|Outcome|Olaratumab + Ifosfamide (Part B)|"Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265200|NCT02677116|OG003|Outcome|Olaratumab +Vincristine + Irinotecan (Part B)|"Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265201|NCT02677116|OG000|Outcome|Olaratumab + Doxorubicin Cycle 1 (Part C)|"Cycle 1: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265202|NCT02677116|OG001|Outcome|Olaratumab + Doxorubicin (Part C)|"Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265203|NCT02677116|OG002|Outcome|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265204|NCT02677116|OG003|Outcome|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265205|NCT02677116|OG002|Outcome|Olaratumab + Ifosfamide (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265206|NCT02677116|OG003|Outcome|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265207|NCT02677116|OG000|Outcome|Olaratumab Alone (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~All cycles = 21 days"
11265208|NCT02677116|OG002|Outcome|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265209|NCT02677116|OG003|Outcome|Olaratumab +Vincristine + Irinotecan (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265210|NCT02677116|OG000|Outcome|Olaratumab + Doxorubicin (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265211|NCT02677116|OG001|Outcome|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265212|NCT02677116|OG002|Outcome|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265213|NCT02677116|OG002|Outcome|Olaratumab + Doxorubicin (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265214|NCT02677116|OG004|Outcome|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265215|NCT02677116|OG004|Outcome|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265216|NCT02677116|EG000|Reported Event|Olaratumab + Vincristine + Irinotecan (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265217|NCT02677116|EG001|Reported Event|Olaratumab + Ifosfamide (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265218|NCT02677116|EG002|Reported Event|Olaratumab + Doxorubicin (Part A)|"Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265219|NCT02677116|EG003|Reported Event|Olaratumab + Vincristine + Irinotecan (Part B)|"Cycle 1: Olaratumab 20 mg/kg administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265220|NCT02677116|EG004|Reported Event|Olaratumab + Ifosfamide (Part B)|"Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.~Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265221|NCT02677116|EG005|Reported Event|Olaratumab + Doxorubicin (Part B)|"Cycle 1: Olaratumab 20 mg/kg alone was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265222|NCT02677116|EG006|Reported Event|Olaratumab + Vincristine + Irinotecan (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265223|NCT02677116|EG007|Reported Event|Olaratumab + Ifosfamide (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265224|NCT02677116|EG008|Reported Event|Olaratumab + Doxorubicin (Part C)|"Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.~All cycles are 21 days."
11265225|NCT02677220|BG000|Baseline|Surgical|Subjects implanted with the CI532 cochlear implant in one ear
10970053|NCT00908596|OG000|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265226|NCT02677220|FG000|Participant Flow|Surgical|Subjects implanted with the CI532 cochlear implant in one ear
11265227|NCT02677220|OG000|Outcome|Surgical|Subjects implanted with the CI532 cochlear implant in one ear
11265228|NCT02677220|OG000|Outcome|Surgical|Subjects with the CI532 cochlear implant in one ear
11265229|NCT02677220|EG000|Reported Event|Surgical|Subjects with the CI532 cochlear implant in one ear
11265230|NCT02677428|BG000|Baseline|Remotely Delivered Benefits Counseling|Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
11265231|NCT02677428|BG001|Baseline|Control|The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation & Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C&P office where issues pertaining to an individual Veteran's specific application are addressed.
11265232|NCT02677428|BG002|Baseline|Total|Total of all reporting groups
11265233|NCT02677428|FG000|Participant Flow|Remotely Delivered Benefits Counseling|Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
11286769|NCT02892409|EG001|Reported Event|Clarithromycin + Amoxicillin + Bismuth + Lansoprazole|Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
11265234|NCT02677428|FG001|Participant Flow|Control Website|The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation & Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C&P office where issues pertaining to an individual Veteran's specific application are addressed.
11265235|NCT02677428|OG000|Outcome|Remotely Delivered Benefits Counseling|Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
11265236|NCT02677428|OG001|Outcome|Control|The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation & Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C&P office where issues pertaining to an individual Veteran's specific application are addressed.
11265237|NCT02677428|EG000|Reported Event|Remotely Delivered Benefits Counseling|Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
11265238|NCT02677428|EG001|Reported Event|Control|The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation & Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C&P office where issues pertaining to an individual Veteran's specific application are addressed.
11265239|NCT02677493|BG000|Baseline|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265240|NCT02677493|BG001|Baseline|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11265241|NCT02677493|BG002|Baseline|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265242|NCT02677493|BG003|Baseline|Total|Total of all reporting groups
11265243|NCT02677493|FG000|Participant Flow|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265244|NCT02677493|FG001|Participant Flow|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11265245|NCT02677493|FG002|Participant Flow|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265246|NCT02677493|OG000|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265247|NCT02677493|OG001|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11265248|NCT02677493|OG002|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265249|NCT02677493|OG001|Outcome|IL-YANG Flu Vaccine Prefilled Syringe.IL-YANG Trivalent Influe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11265250|NCT02677493|OG000|Outcome|IL-YANG Trivalent Vaccine (Combined)|"This Arm/Group is combination of IL-YANG Flu Vaccine Prefilled Syringe and IL-YANG Trivalent Influenza Vaccine Arm/Group.~-Reason that the two arms were combined IL-YANG Flu Vaccine Prefilled Syringe: contains H1N1, H3N2 and Yamagata strain. IL-YANG Trivalent Influenza Vaccine: includes H1N1, H3N2 and Victoria strain.~-> To be used the above two trivalent vaccines as a control for the Quadrivalent vaccine, the results of seroconversion rate of above two trivalent vaccine was combined."
11265251|NCT02677493|OG001|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265252|NCT02677493|EG000|Reported Event|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265253|NCT02677493|EG001|Reported Event|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
11265254|NCT02677493|EG002|Reported Event|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
11265255|NCT02677623|BG000|Baseline|A- Pyridium|"Method of administration: oral~Dose: 200 mg PO with small sip of water~Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps~Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia~Pyridium"
11265256|NCT02677623|BG001|Baseline|B- Sodium Fluorescein|"Method of administration: intravenous~Dose: 25 mg~Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,~Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma~Sodium Fluorescein"
11265257|NCT02677623|BG002|Baseline|C- Mannitol|"Method of administration: irrigant during cystoscopy~Dose: 300cc during cystoscopy to visualize the ureters~Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection~Contraindications when used as a genitourinary irrigation solution: anuria~Mannitol"
11265258|NCT02677623|BG003|Baseline|Control- Normal Saline|"Method of administration: irrigant during cystoscopy~Dose: 300cc~Known adverse events: no known significant adverse events~Contraindications: none~Normal Saline"
11265259|NCT02677623|BG004|Baseline|Total|Total of all reporting groups
11265260|NCT02677623|FG000|Participant Flow|A- Pyridium|"Method of administration: oral~Dose: 200 mg PO with small sip of water~Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps~Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia~Pyridium"
11265261|NCT02677623|FG001|Participant Flow|B- Sodium Fluorescein|"Method of administration: intravenous~Dose: 25 mg~Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,~Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma~Sodium Fluorescein"
11265262|NCT02677623|FG002|Participant Flow|C- Mannitol|"Method of administration: irrigant during cystoscopy~Dose: 300cc during cystoscopy to visualize the ureters~Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection~Contraindications when used as a genitourinary irrigation solution: anuria~Mannitol"
11265263|NCT02677623|FG003|Participant Flow|Control- Normal Saline|"Method of administration: irrigant during cystoscopy~Dose: 300cc~Known adverse events: no known significant adverse events~Contraindications: none~Normal Saline"
11265264|NCT02677623|OG000|Outcome|A- Pyridium|"Method of administration: oral~Dose: 200 mg PO with small sip of water~Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps~Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia~Pyridium"
11265265|NCT02677623|OG001|Outcome|B- Sodium Fluorescein|"Method of administration: intravenous~Dose: 25 mg~Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,~Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma~Sodium Fluorescein"
11265266|NCT02677623|OG002|Outcome|C- Mannitol|"Method of administration: irrigant during cystoscopy~Dose: 300cc during cystoscopy to visualize the ureters~Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection~Contraindications when used as a genitourinary irrigation solution: anuria~Mannitol"
11265267|NCT02677623|OG003|Outcome|Control- Normal Saline|"Method of administration: irrigant during cystoscopy~Dose: 300cc~Known adverse events: no known significant adverse events~Contraindications: none~Normal Saline"
11337536|NCT03586830|EG002|Reported Event|JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11265268|NCT02677623|EG000|Reported Event|A- Pyridium|"Method of administration: oral~Dose: 200 mg PO with small sip of water~Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps~Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia~Pyridium"
11265269|NCT02677623|EG001|Reported Event|B- Sodium Fluorescein|"Method of administration: intravenous~Dose: 25 mg~Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,~Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma~Sodium Fluorescein"
11265270|NCT02677623|EG002|Reported Event|C- Mannitol|"Method of administration: irrigant during cystoscopy~Dose: 300cc during cystoscopy to visualize the ureters~Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection~Contraindications when used as a genitourinary irrigation solution: anuria~Mannitol"
11265271|NCT02677623|EG003|Reported Event|Control- Normal Saline|"Method of administration: irrigant during cystoscopy~Dose: 300cc~Known adverse events: no known significant adverse events~Contraindications: none~Normal Saline"
11265272|NCT02677701|BG000|Baseline|Azithromycin|"azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks~azithromycin: 500mg tablet over-encapsulated to match placebo~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265273|NCT02677701|BG001|Baseline|Placebo|"encapsulated placebo taken by mouth thrice weekly for 6 weeks~placebo (for azithromycin)~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265274|NCT02677701|BG002|Baseline|Total|Total of all reporting groups
11265275|NCT02677701|FG000|Participant Flow|Azithromycin|"azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks~azithromycin: 500mg tablet over-encapsulated to match placebo~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265276|NCT02677701|FG001|Participant Flow|Placebo|"encapsulated placebo taken by mouth thrice weekly for 6 weeks~placebo (for azithromycin)~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265277|NCT02677701|OG000|Outcome|Azithromycin|"azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks~azithromycin: 500mg tablet over-encapsulated to match placebo~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265278|NCT02677701|OG001|Outcome|Placebo|"encapsulated placebo taken by mouth thrice weekly for 6 weeks~placebo (for azithromycin)~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265279|NCT02677701|EG000|Reported Event|Azithromycin|"azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks~azithromycin: 500mg tablet over-encapsulated to match placebo~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265280|NCT02677701|EG001|Reported Event|Placebo|"encapsulated placebo taken by mouth thrice weekly for 6 weeks~placebo (for azithromycin)~inhaled tobramycin: clinically prescribed inhaled tobramycin used by subjects participating in the study"
11265281|NCT02677714|BG000|Baseline|99mTc-rhAnnexin V-128 (Part I / Proof of Concept)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265282|NCT02677714|BG001|Baseline|99mTc-rhAnnexin V-128 (Part II / Phase II)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265283|NCT02677714|BG002|Baseline|Total|Total of all reporting groups
11265284|NCT02677714|FG000|Participant Flow|99mTc-rhAnnexin V-128 (Part I / Proof of Concept)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265285|NCT02677714|FG001|Participant Flow|99mTc-rhAnnexin V-128 (Part II / Phase II)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265286|NCT02677714|OG000|Outcome|99mTc-rhAnnexin V-128 (Part I / Proof of Concept)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265287|NCT02677714|OG001|Outcome|99mTc-rhAnnexin V-128 (Part II / Phase II)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265288|NCT02677714|EG000|Reported Event|99mTc-rhAnnexin V-128 (Part I / Proof of Concept)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11265289|NCT02677714|EG001|Reported Event|99mTc-rhAnnexin V-128 (Part II / Phase II)|After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
11286770|NCT02892422|BG000|Baseline|Flexible-dose of Lu AF35700|Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
11265290|NCT02677740|BG000|Baseline|Inhibitory rTMS (1 Hz)|"Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the"
11265291|NCT02677740|BG001|Baseline|Excitatory rTMS (5 Hz)|"Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv"
11265292|NCT02677740|BG002|Baseline|Total|Total of all reporting groups
11265293|NCT02677740|FG000|Participant Flow|Inhibitory rTMS (1 Hz)|"Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the"
11265294|NCT02677740|FG001|Participant Flow|Excitatory rTMS (5 Hz)|"Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv"
11265295|NCT02677740|OG000|Outcome|Inhibitory rTMS (1 Hz)|"Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the"
11265296|NCT02677740|OG001|Outcome|Excitatory rTMS (5 Hz)|"Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv"
11265297|NCT02677740|EG000|Reported Event|Inhibitory rTMS (1 Hz)|"Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the"
11337537|NCT03586830|EG003|Reported Event|JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
11265298|NCT02677740|EG001|Reported Event|Excitatory rTMS (5 Hz)|"Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.~Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv"
11265299|NCT02677753|BG000|Baseline|Fluoroscopy Guided PNE|"Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.~Fluoroscopy"
11265300|NCT02677753|BG001|Baseline|PNE Without Fluoroscopic Guidance|No fluoroscopy will be used during or after the placement of the lead wires.
11265301|NCT02677753|BG002|Baseline|Total|Total of all reporting groups
11265302|NCT02677753|FG000|Participant Flow|Fluoroscopy Guided PNE|"Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.~Fluoroscopy"
11265303|NCT02677753|FG001|Participant Flow|PNE Without Fluoroscopic Guidance|No fluoroscopy will be used during or after the placement of the lead wires.
11265304|NCT02677753|OG000|Outcome|Fluoroscopy Guided PNE|"Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.~Fluoroscopy"
11265305|NCT02677753|OG001|Outcome|PNE Without Fluoroscopic Guidance|No fluoroscopy will be used during or after the placement of the lead wires.
11265306|NCT02677753|EG000|Reported Event|Fluoroscopy Guided PNE|"Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.~Fluoroscopy"
11265307|NCT02677753|EG001|Reported Event|PNE Without Fluoroscopic Guidance|No fluoroscopy will be used during or after the placement of the lead wires.
11265308|NCT02677766|BG000|Baseline|Intervention|"Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM~occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0."
11265309|NCT02677766|BG001|Baseline|Usual Care|"Usual care consists in rehabilitation treatment delivered by a multidisciplinary team~Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team"
11265310|NCT02677766|BG002|Baseline|Total|Total of all reporting groups
11265311|NCT02677766|FG000|Participant Flow|Intervention|"Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM~occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0."
11265312|NCT02677766|FG001|Participant Flow|Usual Care|"Usual care consists in rehabilitation treatment delivered by a multidisciplinary team~Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team"
11265313|NCT02677766|OG000|Outcome|Intervention|"Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM~occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0."
11265314|NCT02677766|OG001|Outcome|Usual Care|"Usual care consists in rehabilitation treatment delivered by a multidisciplinary team~Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team"
11265315|NCT02677766|EG000|Reported Event|Intervention|"Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM~occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0."
11265316|NCT02677766|EG001|Reported Event|Usual Care|"Usual care consists in rehabilitation treatment delivered by a multidisciplinary team~Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team"
11265317|NCT02677779|BG000|Baseline|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11265318|NCT02677779|BG001|Baseline|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11265319|NCT02677779|BG002|Baseline|Total|Total of all reporting groups
11265320|NCT02677779|FG000|Participant Flow|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11265321|NCT02677779|FG001|Participant Flow|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11265322|NCT02677779|OG000|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11265323|NCT02677779|OG001|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11265324|NCT02677779|EG000|Reported Event|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
11265325|NCT02677779|EG001|Reported Event|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
11265326|NCT02677844|BG000|Baseline|Cohort 1|Single ascending doses of 200, 300, and 400 mg of Abemaciclib & Placebo were administered orally in one of the four sequences in each period.
11265327|NCT02677844|BG001|Baseline|Cohort 2|Single ascending doses of 400, 600 mg Abemaciclib & Placebo were administered orally in one of the four sequences in each period. Loperamide 8mg was administered orally in period 4 (DDI) along with Abemaciclib.
11265328|NCT02677844|BG002|Baseline|Total|Total of all reporting groups
11265329|NCT02677844|FG000|Participant Flow|Cohort 1 Sequence 1|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 1- Placebo; Period 2- 200 milligram (mg) Abemaciclib; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib."
11265330|NCT02677844|FG001|Participant Flow|Cohort 1 Sequence 2|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 1- 200 mg Abemaciclib; Period 2- Placebo; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib."
11265331|NCT02677844|FG002|Participant Flow|Cohort 1 Sequence 3|"Abemaciclib matching placebo was administered orally on day 1 of each period based on below dosing schedule.~Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- Placebo; Period 4- 400 mg Abemaciclib."
11265332|NCT02677844|FG003|Participant Flow|Cohort 1 Sequence 4|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- 400 mg Abemaciclib; Period 4- Placebo."
11265333|NCT02677844|FG004|Participant Flow|Cohort 2 Sequence 1|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 4 (DDI)- 8 mg Loperamide (on day -3 & 1) & Placebo; Period 5- Placebo; Period 6- 400 mg Abemaciclib; Period 7- 600 mg Abemaciclib."
11265334|NCT02677844|FG005|Participant Flow|Cohort 2 Sequence 2|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 4 (DDI)- 8 mg Loperamide (on Day -3 & 1) & 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- Placebo; Period 7- 600 mg Abemaciclib."
11265335|NCT02677844|FG006|Participant Flow|Cohort 2 Sequence 3|"Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:~Period 4 (DDI)- 8 mg Loperamide (on day -3 & 1) & 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- 600 mg Abemaciclib; Period 7- Placebo."
11265336|NCT02677844|OG000|Outcome|200 mg Abemaciclib|200 mg Abemaciclib was given orally.
11265337|NCT02677844|OG001|Outcome|300 mg Abemaciclib|300 mg Abemaciclib was given orally.
10848152|NCT00288860|OG000|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
11265338|NCT02677844|OG002|Outcome|400 mg Abemaciclib|400mg Abemaciclib was given orally.
11265339|NCT02677844|OG003|Outcome|600 mg Abemaciclib|600 mg Abemaciclib was given orally.
11265340|NCT02677844|OG002|Outcome|400 mg Abemaciclib|400 mg Abemaciclib was given orally.
11265341|NCT02677844|OG004|Outcome|400 mg Abemaciclib + Loperamide 8mg|400 mg Abemaciclib was given orally along with 8mg Loperamide.
11265342|NCT02677844|OG004|Outcome|400 mg Abemaciclib + 8 mg Loperamide|400 mg Abemaciclib was given orally along with 8 mg Loperamide.
11265343|NCT02677844|OG000|Outcome|8 mg Loperamide|8 mg Loperamide was given orally.
11265344|NCT02677844|OG001|Outcome|8 mg Loperamide + 400 mg Abemaciclib|8 mg Loperamide was given orally along with 400 mg Abemaciclib.
11265345|NCT02677844|EG000|Reported Event|Placebo|Matching placebo was given orally in place of Abemaciclib.
11265346|NCT02677844|EG001|Reported Event|200 mg Abemaciclib|200 mg Abemaciclib was given orally.
11265347|NCT02677844|EG002|Reported Event|300 mg Abemaciclib|300 mg Abemaciclib was given orally.
11265348|NCT02677844|EG003|Reported Event|400 mg Abemaciclib|400 mg Abemaciclib was given orally.
11265349|NCT02677844|EG004|Reported Event|600 mg Abemaciclib|600 mg Abemaciclib was given orally.
11265350|NCT02677844|EG005|Reported Event|8 mg Loperamide|8 mg Loperamide was given orally.
11265351|NCT02677844|EG006|Reported Event|8 mg Loperamide + Placebo|8 mg Loperamide was given orally & matching placebo was used for Abemaciclib
11265352|NCT02677844|EG007|Reported Event|8 mg Loperamide + 400 mg Abemaciclib|400 mg Abemaciclib was given orally along with 8 mg Loperamide.
11265353|NCT02678000|BG000|Baseline|LHW090 (PART 1)|For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment.
11265354|NCT02678000|BG001|Baseline|Placebo (PART 1)|For Part 1, patients will receive matching placebo once daily for 12 days.
11265355|NCT02678000|BG002|Baseline|LHW090 100mg (PART 2)|For PART 2, patients will receive LWH090 100 mg for 4 weeks
11265356|NCT02678000|BG003|Baseline|LHW090 200mg (PART 2)|For PART 2, patients will receive LWH090 200 mg for 4 weeks
11265357|NCT02678000|BG004|Baseline|Placebo (PART 2)|For Part 2, patients will receive matching placebo once daily for 4 weeks.
11265358|NCT02678000|BG005|Baseline|Total|Total of all reporting groups
11265359|NCT02678000|FG000|Participant Flow|LHW090 (PART 1)|For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment.
11265360|NCT02678000|FG001|Participant Flow|Placebo (PART 1)|For Part 1, patients will receive matching placebo once daily for 12 days.
11265361|NCT02678000|FG002|Participant Flow|LHW090 100mg (PART 2)|For PART 2, patients will receive LWH090 100 mg for 4 weeks
11265362|NCT02678000|FG003|Participant Flow|LHW090 200mg (PART 2)|For PART 2, patients will receive LWH090 200 mg for 4 weeks
11265363|NCT02678000|FG004|Participant Flow|Placebo (PART 2)|For Part 2, patients will receive matching placebo once daily for 4 weeks.
11265364|NCT02678000|OG000|Outcome|LHW090 25 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 25 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265365|NCT02678000|OG001|Outcome|LHW090 50 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 50 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265366|NCT02678000|OG002|Outcome|LHW090 100 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265367|NCT02678000|OG003|Outcome|Placebo (PART 1)|For Part 1, patients will receive matching placebo once daily for 12 days.
11265368|NCT02678000|OG003|Outcome|LHW090/LHV527 25 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 25 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)
11265369|NCT02678000|OG004|Outcome|LHW090/LHV527 50 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 50 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)
11265370|NCT02678000|OG005|Outcome|LHW090/LHV527 100 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)
11265371|NCT02678000|OG000|Outcome|LHW090 100mg (PART 2)|For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks
11265372|NCT02678000|OG001|Outcome|LHW090 200mg (PART 2)|For PART 2, patients will receive LWH090 200 mg once daily for 4 weeks
11265373|NCT02678000|OG002|Outcome|Placebo (PART 2)|For Part 2, patients will receive matching placebo once daily for 4 weeks.
11265374|NCT02678000|OG002|Outcome|LHW090 100 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment
11265375|NCT02678000|OG003|Outcome|LHW090 100mg (PART 2)|For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks
11265376|NCT02678000|OG004|Outcome|LHW090 200mg (PART 2)|For PART 2, patients will receive LWH090 200 mg once daily for 4 weeks
11265377|NCT02678000|OG000|Outcome|LHW090 100 mg (PART 2)|For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks
11265378|NCT02678000|OG002|Outcome|LHW090/LHV527 100 mg (PART 2)|For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks. (PK draw with active metabolite, LHV527)
11265379|NCT02678000|OG003|Outcome|LHW090/LHV527 200 mg (PART 2)|For PART 2, patients will receive LWH090 200 mg once daily for 4 weeks. (PK draw with active metabolite, LHV527)
11265380|NCT02678000|EG000|Reported Event|LHW090 25 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 25 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265381|NCT02678000|EG001|Reported Event|LHW090 50 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 50 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265382|NCT02678000|EG002|Reported Event|LHW090 100 mg (PART 1)|For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment.
11265383|NCT02678000|EG003|Reported Event|PART 1 Placebo|For Part 1, patients will receive matching placebo once daily for 12 days.
11265384|NCT02678000|EG004|Reported Event|LHW090 100mg (PART 2)|For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks
11265385|NCT02678000|EG005|Reported Event|LHW090 200 mg (PART 2)|For PART 2, patients will receive LWH090 200 mg once daily for 4 weeks
11265386|NCT02678000|EG006|Reported Event|Placebo (PART 2|For Part 2, patients will receive matching placebo once daily for 4 weeks.
11265387|NCT02678039|BG000|Baseline|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of epidural catheter in the epidural space at the desired location.~Following epidural catheter placement 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11265388|NCT02678039|BG001|Baseline|Traditional|"The traditional approach for placement of an epidural catheter is with indirect indicators including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr."
11265389|NCT02678039|BG002|Baseline|Total|Total of all reporting groups
11265390|NCT02678039|FG000|Participant Flow|Traditional|"The traditional approach for placement of an epidural catheter is indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of placement: depth of needle and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle and the needle removed. After catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr."
11337538|NCT03587207|BG000|Baseline|MenABCWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).
11265391|NCT02678039|FG001|Participant Flow|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the epidural space at the desired location.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11265392|NCT02678039|OG000|Outcome|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi"
11265393|NCT02678039|OG001|Outcome|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.~Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b"
11265394|NCT02678039|EG000|Reported Event|Fluoroscopy|"Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr"
11265395|NCT02678039|EG001|Reported Event|Traditional|"The traditional approach for placement of an epidural catheter is used with indirect indicators of placement.~Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control.~Traditional: An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr ."
11265396|NCT02678247|BG000|Baseline|Ischial Containment Socket Then NU-FlexSIV Socket|Participants wore the Ischial Containment Socket for 7 weeks then wore the NU-FlexSIV Socket for 7 weeks.
11265397|NCT02678247|BG001|Baseline|NU-FlexSIV Socket Then Ischial Containment Socket|Participants wore the NU-FlexSIV Socket for 7 weeks then wore the Ischial Containment Socket for 7 weeks.
11265398|NCT02678247|BG002|Baseline|Total|Total of all reporting groups
11265399|NCT02678247|FG000|Participant Flow|Ischial Containment Socket Then NU-FlexSIV Socket|Participants first received the Ischial Containment Socket which they wore for 7 weeks, then they received the NU-FlexSIV Socket which they wore for 7 weeks.
11265400|NCT02678247|FG001|Participant Flow|NU-FlexSIV Socket Then Ischial Containment Socket|Participants first received the NU-FlexSIV Socket which they wore for 7 weeks, then they received the Ischial Containment Socket which they wore for 7 weeks.
11265401|NCT02678247|OG000|Outcome|NU-FlexSIV Socket|Participants wore the NU-FlexSIV Socket for 7 weeks
11265402|NCT02678247|OG001|Outcome|Ischial Containment Socket|Participants wore the Ischial Containment Socket for 7 weeks
11265403|NCT02678247|OG000|Outcome|NU-FlexSIV Socket|Participant wore the NU-FlexSIV Socket for 7 weeks.
11265404|NCT02678247|OG001|Outcome|Ischial Containment Socket|Participant wore the Ischial Containment Socket for 7 weeks.
11265405|NCT02678247|OG000|Outcome|NU-FlexSIV Socket|Participants wore the NU-FlexSIV Socket for 7 weeks.
11265406|NCT02678247|OG001|Outcome|Ischial Containment Socket|Participants wore the Ischial Containment Socket for 7 weeks.
11265407|NCT02678247|OG001|Outcome|IC Socket|Participants wore the Ischial Containment Socket for 7 weeks.
11265408|NCT02678247|EG000|Reported Event|Ischial Containment Socket|Participants wore the Ischial Containment Socket for 7 weeks.
11265409|NCT02678247|EG001|Reported Event|NU-FlexSIV Socket|Participants wore the NU-FlexSIV Socket for 7 weeks.
11265410|NCT02678286|BG000|Baseline|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265411|NCT02678286|BG001|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265412|NCT02678286|BG002|Baseline|Total|Total of all reporting groups
11265413|NCT02678286|FG000|Participant Flow|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265414|NCT02678286|FG001|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265415|NCT02678286|OG000|Outcome|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265416|NCT02678286|OG001|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265417|NCT02678286|EG000|Reported Event|N1539 30 mg|"N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses.~N1539"
11265418|NCT02678286|EG001|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
11265419|NCT02678390|BG000|Baseline|Healthy Women|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265420|NCT02678390|BG001|Baseline|Women With Prediabetes|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265421|NCT02678390|BG002|Baseline|Total|Total of all reporting groups
11265422|NCT02678390|FG000|Participant Flow|Healthy Women|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265423|NCT02678390|FG001|Participant Flow|Women With Prediabetes|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265424|NCT02678390|OG000|Outcome|Healthy Women|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265425|NCT02678390|OG001|Outcome|Women With Prediabetes|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265426|NCT02678390|EG000|Reported Event|Healthy Women|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
10848153|NCT00288860|OG001|Outcome|Treatment as Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
10848154|NCT00288860|OG001|Outcome|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
11265427|NCT02678390|EG001|Reported Event|Women With Prediabetes|"Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.~Interventions:~A control day with no MCT and no aerobic exercise.~A 5 day consecutive MCT intake of 30 g/day.~30 minutes of aerobic exercise at 70% to 80% HRR of intensity.~A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days.~MCT: A 5 day consecutive MCT intake of 30 g/day.~MCT+ aerobic exercise: A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.~Aerobic exercise: A single period of 30 minutes of aerobic exercise (70% to 80% HRR).~Control day: No MCT or aerobic exercise"
11265428|NCT02678416|BG000|Baseline|Part 1|All participants who received a drug product in Part 1
11265429|NCT02678416|BG001|Baseline|Part 2|All participants who received a drug product in Part 2
11265430|NCT02678416|BG002|Baseline|Total|Total of all reporting groups
11265431|NCT02678416|FG000|Participant Flow|Part 1|All participants receive all products in random sequence
11265432|NCT02678416|OG000|Outcome|IV Acetaminophen|All participants received IV acetaminophen
11265433|NCT02678416|OG001|Outcome|Oral Acetaminophen|All participants received oral acetaminophen
11265434|NCT02678416|OG002|Outcome|Placebo|All participants received placebo
11265435|NCT02678416|OG003|Outcome|Morphine|All participants received morphine
11265436|NCT02678416|OG000|Outcome|Part 2: IV Acetaminophen|All participants received IV acetaminophen
11265437|NCT02678416|OG001|Outcome|Part 2: Oral Acetaminophen|All participants received oral acetaminophen
11265438|NCT02678416|OG002|Outcome|Part 2: Placebo|All participants received placebo
11265439|NCT02678416|OG003|Outcome|Part 2: IV Morphine|All participants received morphine
11265440|NCT02678416|EG000|Reported Event|Part 1: IV Acetaminophen|All participants received IV acetaminophen
11265441|NCT02678416|EG001|Reported Event|Part 1: Oral Acetaminophen|All participants received oral acetaminophen
11265442|NCT02678416|EG002|Reported Event|Part 1: Placebo|All participants received placebo
11265443|NCT02678416|EG003|Reported Event|Part 1: Morphine|All participants received morphine
11265444|NCT02678416|EG004|Reported Event|Part 2: IV Acetaminophen|All participants received IV acetaminophen
11265445|NCT02678416|EG005|Reported Event|Part 2: Oral Acetaminophen|All participants received oral acetaminophen
11265446|NCT02678416|EG006|Reported Event|Part 2: Placebo|All participants received placebo
11265447|NCT02678416|EG007|Reported Event|Part 2: Morphine|All participants received morphine
11265448|NCT02678442|BG000|Baseline|FNB First, Then FNA|"In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).~Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.~Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds."
11265449|NCT02678442|BG001|Baseline|FNA First, Then FNB|"In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).~Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.~Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds."
11265450|NCT02678442|BG002|Baseline|Total|Total of all reporting groups
11265451|NCT02678442|FG000|Participant Flow|FNB First, Then FNA|"In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).~Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.~Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds."
11265452|NCT02678442|FG001|Participant Flow|FNA First, Then FNB|"In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).~Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.~Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds."
11265453|NCT02678442|OG000|Outcome|Fine Needle Biopsy (FNB)|Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
11265454|NCT02678442|OG001|Outcome|Fine Needle Aspiration (FNA)|Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
11265455|NCT02678442|EG000|Reported Event|Fine Needle Biopsy (FNB)|Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
11265456|NCT02678442|EG001|Reported Event|Fine Needle Aspiration (FNA)|Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
11265457|NCT02678676|BG000|Baseline|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11265458|NCT02678676|BG001|Baseline|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11265459|NCT02678676|BG002|Baseline|Total|Total of all reporting groups
11265460|NCT02678676|FG000|Participant Flow|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11265461|NCT02678676|FG001|Participant Flow|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11265462|NCT02678676|OG000|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11265463|NCT02678676|OG001|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11265464|NCT02678676|EG000|Reported Event|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
11265465|NCT02678676|EG001|Reported Event|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
11265466|NCT02678923|BG000|Baseline|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11265467|NCT02678923|BG001|Baseline|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11265468|NCT02678923|BG002|Baseline|Total|Total of all reporting groups
11265469|NCT02678923|FG000|Participant Flow|MDCO-216|20 milligrams/kilogram (mg/kg) of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29
11265470|NCT02678923|FG001|Participant Flow|Placebo|360 mL of placebo (0.9% sodium chloride [NaCl] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11265471|NCT02678923|OG000|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11265472|NCT02678923|OG001|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11265473|NCT02678923|EG000|Reported Event|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
11265474|NCT02678923|EG001|Reported Event|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
11265475|NCT02679079|BG000|Baseline|Placebo|Participants received matching placebo once daily for 6 weeks.
11265476|NCT02679079|BG001|Baseline|NBI-98854 Low Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day. Participants aged 12 to 17 years received 20 mg/day.
11265477|NCT02679079|BG002|Baseline|NBI-98854 High Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day for the first week followed by 20 mg/day for the remainder of the treatment period. Participants aged 12 to 17 years received 20 mg/day for the first week followed by 40 mg/day for the remainder of the treatment period.
11265478|NCT02679079|BG003|Baseline|Total|Total of all reporting groups
11265479|NCT02679079|FG000|Participant Flow|Placebo|Participants received matching placebo once daily for 6 weeks.
11265480|NCT02679079|FG001|Participant Flow|NBI-98854 Low Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day. Participants aged 12 to 17 years received 20 mg/day.
11265481|NCT02679079|FG002|Participant Flow|NBI-98854 High Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day for the first week followed by 20 mg/day for the remainder of the treatment period. Participants aged 12 to 17 years received 20 mg/day for the first week followed by 40 mg/day for the remainder of the treatment period.
11265482|NCT02679079|OG000|Outcome|Placebo|Participants received matching placebo once daily for 6 weeks.
11265483|NCT02679079|OG001|Outcome|NBI-98854 Low Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day. Participants aged 12 to 17 years received 20 mg/day.
11265484|NCT02679079|OG002|Outcome|NBI-98854 High Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day for the first week followed by 20 mg/day for the remainder of the treatment period. Participants aged 12 to 17 years received 20 mg/day for the first week followed by 40 mg/day for the remainder of the treatment period.
11265485|NCT02679079|EG000|Reported Event|Placebo|Participants received matching placebo once daily for 6 weeks.
11265486|NCT02679079|EG001|Reported Event|NBI-98854 Low Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day. Participants aged 12 to 17 years received 20 mg/day.
11265487|NCT02679079|EG002|Reported Event|NBI-98854 High Dose|Participants received valbenazine once daily for 6 weeks. Participants aged 6 to 11 years received 10 mg/day for the first week followed by 20 mg/day for the remainder of the treatment period. Participants aged 12 to 17 years received 20 mg/day for the first week followed by 40 mg/day for the remainder of the treatment period.
11337539|NCT03587207|BG001|Baseline|rMenBOMV+ACWY_S Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).
11265488|NCT02679222|BG000|Baseline|Supplementation|"Protocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT [tricaprylin/tricaprin]; coconut oil + MCT [50:50]; Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day.~Coconut oil: 20 g of coconut oil~Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)~MCT: 20 g of MCT (60 of C8+40 of C10)~Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin~Tricaprylin: 20 g tricaprylin~Tricaprin: 20 g tricaprin~Control: No supplement taken on this visit"
11265489|NCT02679222|FG000|Participant Flow|Supplementation|"Protocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT [tricaprylin/tricaprin]; coconut oil + MCT [50:50]; Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day.~Coconut oil: 20 g of coconut oil~Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)~MCT: 20 g of MCT (60 of C8+40 of C10)~Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin~Tricaprylin: 20 g tricaprylin~Tricaprin: 20 g tricaprin~Control: No supplement taken on this visit"
11265490|NCT02679222|OG000|Outcome|Control|"vehicle (Control) taken twice, once at breakfast and once at mid-day.~Control: No supplement taken on this visit"
11265491|NCT02679222|OG001|Outcome|Medium Chain Triglyceride|"20 mL of MCT taken twice, once at breakfast and once at mid-day.~MCT: 20 g of MCT (60 of C8+40 of C10)"
11265492|NCT02679222|OG002|Outcome|Tricaprin|"20 mL of MCT tricaprin taken twice, once at breakfast and once at mid-day.~Tricaprin: 20 g tricaprin"
11265493|NCT02679222|OG003|Outcome|Tricaprylin|"20 mL of tricaprylin taken twice, once at breakfast and once at mid-day.~Tricaprylin: 20 g tricaprylin"
11265494|NCT02679222|OG004|Outcome|Coconut Oil|"20 mL of Coconut oil taken twice, once at breakfast and once at mid-day.~Coconut oil: 20 g of coconut oil"
11265495|NCT02679222|OG005|Outcome|Coconut Oil + MCT|"20 mL of coconut oil + MCT taken twice, once at breakfast and once at mid-day.~Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)"
11265496|NCT02679222|OG006|Outcome|Coconut Oil + Tricaprylin|"20 mL of Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day.~Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin"
11265497|NCT02679222|OG002|Outcome|Tricaprin|"20 mL of MCT tricaprintaken twice, once at breakfast and once at mid-day.~Tricaprin: 20 g tricaprin"
11265498|NCT02679222|OG006|Outcome|Coconut Oil +t Tricaprylin|"20 mL of Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day.~Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin"
11265499|NCT02679222|EG000|Reported Event|Supplementation|"Protocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT [tricaprylin/tricaprin]; coconut oil + MCT [50:50]; Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day.~Coconut oil: 20 g of coconut oil~Coconut oil + MCT: 10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)~MCT: 20 g of MCT (60 of C8+40 of C10)~Coconut oil + tricaprylin: 10 g coconut oil + 10 g tricaprylin~Tricaprylin: 20 g tricaprylin~Tricaprin: 20 g tricaprin~Control: No supplement taken on this visit"
11265500|NCT02679235|BG000|Baseline|Triheptanoin|"Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.~POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.~control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit."
11265501|NCT02679235|FG000|Participant Flow|Triheptanoin|"Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.~POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.~control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit."
11265502|NCT02679235|OG000|Outcome|Triheptanoin|"Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.~POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.~control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit."
11265503|NCT02679235|EG000|Reported Event|Triheptanoin|"Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.~POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.~control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit."
11265504|NCT02679274|BG000|Baseline|Placebo|"Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.~Placebo: Intermittent intramuscular injections of saline (males and females)."
11265505|NCT02679274|BG001|Baseline|Testosterone|"Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.~Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females)."
11265506|NCT02679274|BG002|Baseline|Total|Total of all reporting groups
11265507|NCT02679274|FG000|Participant Flow|Placebo|"Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.~Placebo: Intermittent intramuscular injections of saline (males and females)."
11265508|NCT02679274|FG001|Participant Flow|Testosterone|"Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.~Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females)."
11265509|NCT02679274|OG000|Outcome|Placebo|"Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.~Placebo: Intermittent intramuscular injections of saline (males and females)."
11265510|NCT02679274|OG001|Outcome|Testosterone|"Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.~Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females)."
11265511|NCT02679274|EG000|Reported Event|Placebo|"Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.~Placebo: Intermittent intramuscular injections of saline (males and females)."
11265512|NCT02679274|EG001|Reported Event|Testosterone|"Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.~Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females)."
11265513|NCT02679287|BG000|Baseline|Group A|"Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive."
11265514|NCT02679287|BG001|Baseline|Group B|"Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive."
11265515|NCT02679287|BG002|Baseline|Total|Total of all reporting groups
11265516|NCT02679287|FG000|Participant Flow|Group A|"Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.~SAP=sensor-augmented pump only~USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight~USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control"
11265517|NCT02679287|FG001|Participant Flow|Group B|"Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.~SAP=sensor-augmented pump only~USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight~USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control"
11265518|NCT02679287|OG000|Outcome|Group A and Group B Combined|"Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)~Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP~SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive."
11265519|NCT02679287|OG000|Outcome|Sensor-augmented Pump Therapy (SAP)|Use of study CGM and personal pump for 8 weeks.
11265520|NCT02679287|OG001|Outcome|Evening and Overnight Closed-Loop Control|Use of CLC evening to overnight hours for two sessions of 8 weeks
11265521|NCT02679287|OG002|Outcome|24/7 Closed-Loop Control|Use of CLC 24/7 for 8 weeks
11265522|NCT02679287|OG000|Outcome|Group A|"Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive."
10970054|NCT00908596|OG001|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265523|NCT02679287|OG001|Outcome|Group B|"Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP~CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive."
11265524|NCT02679287|EG000|Reported Event|Sensor-Augmented Pump Therapy (SAP)|8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
11265525|NCT02679287|EG001|Reported Event|Evening and Overnight Closed-Loop Control|8 week study phases (2) for both Group A and Group B that underwent the same procedures in different orders.
11265526|NCT02679287|EG002|Reported Event|24/7 Closed-Loop Control|8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
11265527|NCT02679287|EG003|Reported Event|Other|This includes any study periods outside of other study phases listed such as screening and washout periods for both Group A and Group B that underwent the same procedures in different orders.
11265528|NCT02679469|BG000|Baseline|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11265529|NCT02679469|FG000|Participant Flow|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11265530|NCT02679469|OG000|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11265531|NCT02679469|EG000|Reported Event|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
11265532|NCT02679573|BG000|Baseline|Delafloxacin|Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
11265533|NCT02679573|BG001|Baseline|Moxifloxacin/Linezolid|"Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total~Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses"
11265534|NCT02679573|BG002|Baseline|Total|Total of all reporting groups
11265535|NCT02679573|FG000|Participant Flow|Delafloxacin|Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
11265536|NCT02679573|FG001|Participant Flow|Moxifloxacin/Linezolid|"Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total~Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses"
11265537|NCT02679573|OG000|Outcome|Delafloxacin|Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
11265538|NCT02679573|OG001|Outcome|Moxifloxacin/Linezolid|"Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total~Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses"
11265539|NCT02679573|EG000|Reported Event|Delafloxacin|Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
11265540|NCT02679573|EG001|Reported Event|Moxifloxacin/Linezolid|"Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total~Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses"
11265541|NCT02679690|BG000|Baseline|Patient Population Pre Intervention|Patients with heart failure demographics who recieved standard dietary sodium education
11265542|NCT02679690|FG000|Participant Flow|Patients With Heart Failure|"Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention.~Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure.~Color-Coded Cue Cards: The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping."
11265543|NCT02679690|OG000|Outcome|Patients With Heart Failure|"Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention.~Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure.~Color-Coded Cue Cards: The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping."
11265544|NCT02679690|OG000|Outcome|Participants Mean Sodium Post Standard Dietary Education|Ten participants with heart failure received standard dietary sodium education and then two weeks later chose 15 items from a simulated grocery store. These 15 items were tallied for the mean milligrams of sodium per serving.
11265545|NCT02679690|OG001|Outcome|Participants Dietary Sodium Choices Post Color-coded Cue Card|The mean milligrams of dietary sodium from the 15 grocery items chosen post color-coded cue card education intervention.
11265546|NCT02679690|EG000|Reported Event|Patients With Heart Failure|"Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention.~Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure.~Color-Coded Cue Cards: The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping."
11265547|NCT02679729|BG000|Baseline|AZD5634 - Inhaled 10 μg|Participants received inhaled single doses of AZD5634 10 μg under fasted conditions
11265548|NCT02679729|BG001|Baseline|AZD5634 27 μg|Participants received inhaled single doses of AZD5634 27 μg under fasted conditions
11265549|NCT02679729|BG002|Baseline|AZD5634 81 μg|Participants received inhaled single doses of AZD5634 81 μg under fasted conditions
11265550|NCT02679729|BG003|Baseline|AZD5634 216 μg|Participants received inhaled single doses of AZD5634 216 μg under fasted conditions
11265551|NCT02679729|BG004|Baseline|AZD5634 648 μg|Participants received inhaled single doses of AZD5634 648 μg under fasted conditions
11265552|NCT02679729|BG005|Baseline|AZD5634 1296 μg|Participants received inhaled single doses of AZD5634 1296 μg under fasted conditions
11265553|NCT02679729|BG006|Baseline|AZD5634 1692 μg|Participants received inhaled single doses of AZD5634 1692 μg under fasted conditions
11265554|NCT02679729|BG007|Baseline|Placebo|2 participants per dose level received single dose of placebo in Part A
11265555|NCT02679729|BG008|Baseline|AZD5634 - IV 65 μg and IN 1692 μg|After safety evaluation of all inhaled AZD5634 cohorts, 6 participants (who did not participate in Part A) were admitted for inhaled (1692 μg AZD5634) and IV (65 μg AZD5634) dosing (fixed dosing; IV first followed by inhalation), with at least a 14 day washout between dosing
11265556|NCT02679729|BG009|Baseline|Total|Total of all reporting groups
11265557|NCT02679729|FG000|Participant Flow|Part A - AZD5634 - 10 μg|Participants received inhaled single doses of AZD5634 10 μg under fasted conditions
11265558|NCT02679729|FG001|Participant Flow|Part A - AZD5634 27 μg|Participants received inhaled single doses of AZD5634 27 μg under fasted conditions
11265559|NCT02679729|FG002|Participant Flow|Part A - AZD5634 81 μg|Participants received inhaled single doses of AZD5634 81 μg under fasted conditions
11265560|NCT02679729|FG003|Participant Flow|Part A - AZD5634 216 μg|Participants received inhaled single doses of AZD5634 216 μg under fasted conditions
11265561|NCT02679729|FG004|Participant Flow|Part A - AZD5634 648 μg|Participants received inhaled single doses of AZD5634 648 μg under fasted conditions
11265562|NCT02679729|FG005|Participant Flow|Part A - AZD5634 1296 μg|Participants received inhaled single doses of AZD5634 1296 μg under fasted conditions
11265563|NCT02679729|FG006|Participant Flow|Part A - AZD5634 1692 μg|Participants received inhaled single doses of AZD5634 1692 μg under fasted conditions
11265564|NCT02679729|FG007|Participant Flow|Part A - Placebo|2 participants per dose level received single dose of placebo in Part A
11265565|NCT02679729|FG008|Participant Flow|PartB- AZD5634-Intravenous(IV) 65μg and Inhalation(IN) 1692μg|After safety evaluation of all inhaled AZD5634 cohorts, 6 participants (who did not participate in Part A) were admitted for inhaled (1692 μg AZD5634) and IV (65 μg AZD5634) dosing (fixed dosing; IV first followed by inhalation), with at least a 14 day washout between dosing
11265566|NCT02679729|OG000|Outcome|Part A - AZD5634 10 µg|Participants received inhaled single doses of AZD5634 10 µg under fasted conditions
11265567|NCT02679729|OG001|Outcome|Part A - AZD5634 27 µg|Participants received inhaled single doses of AZD5634 27 µg under fasted conditions
11265568|NCT02679729|OG002|Outcome|Part A - AZD5634 81 µg|Participants received inhaled single doses of AZD5634 81 µg under fasted conditions
11265569|NCT02679729|OG003|Outcome|Part A - AZD5634 216 µg|Participants received inhaled single doses of AZD5634 216 µg under fasted conditions
11265570|NCT02679729|OG004|Outcome|Part A - AZD5634 648 µg|Participants received inhaled single doses of AZD5634 648 µg under fasted conditions
11265571|NCT02679729|OG005|Outcome|Part A - AZD5634 1296 µg|Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions
11265572|NCT02679729|OG006|Outcome|Part A - AZD5634 1692 µg|Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions
11265573|NCT02679729|OG007|Outcome|Part A - Placebo for AZD5634|2 participants per dose level received single dose of placebo in Part A
11265574|NCT02679729|OG008|Outcome|Part B - AZD5634 IV 65 µg|Participants received IV dose of AZD5634 65 µg
11265575|NCT02679729|OG009|Outcome|Part B - AZD5634 IN 1692 µg|Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
11265576|NCT02679729|OG000|Outcome|Part A - AZD5634 81 µg|Participants received inhaled single doses of AZD5634 81 µg under fasted conditions
11265577|NCT02679729|OG001|Outcome|Part A - AZD5634 216 µg|Participants received inhaled single doses of AZD5634 216 µg under fasted conditions
11265578|NCT02679729|OG002|Outcome|Part A - AZD5634 648 µg|Participants received inhaled single doses of AZD5634 648 µg under fasted conditions
11265579|NCT02679729|OG003|Outcome|Part A - AZD5634 1296 µg|Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions
11265580|NCT02679729|OG004|Outcome|Part A - AZD5634 1692 µg|Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions
11265581|NCT02679729|OG005|Outcome|Part B - AZD5634 IV 65 µg|Participants received IV dose of AZD5634 65 µg
11265582|NCT02679729|OG006|Outcome|Part B - AZD5634 IN 1692 µg|Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
11265583|NCT02679729|OG000|Outcome|Part B - AZD5634 IV 65 µg|Participants received IV dose of AZD5634 65 µg
11265584|NCT02679729|OG001|Outcome|Part B - AZD5634 IN 1692 µg|Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
11265585|NCT02679729|OG005|Outcome|Part B - AZD5634 IN 1692 µg|Participants received an IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
11265586|NCT02679729|EG000|Reported Event|Part A - AZD5634 10 µg|Participants received inhaled single doses of AZD5634 10 µg under fasted conditions
11265587|NCT02679729|EG001|Reported Event|Part A - AZD5634 27 µg|Participants received inhaled single doses of AZD5634 27 µg under fasted conditions
11265588|NCT02679729|EG002|Reported Event|Part A - AZD5634 81 µg|Participants received inhaled single doses of AZD5634 81 µg under fasted conditions
11265589|NCT02679729|EG003|Reported Event|Part A - AZD5634 216 µg|Participants received inhaled single doses of AZD5634 216 µg under fasted conditions
11265590|NCT02679729|EG004|Reported Event|Part A - AZD5634 648 µg|Participants received inhaled single doses of AZD5634 648 µg under fasted conditions
11265591|NCT02679729|EG005|Reported Event|Part A - AZD5634 1296 µg|Participants received inhaled single doses of AZD5634 1296 µg under fasted conditions
11265592|NCT02679729|EG006|Reported Event|Part A - AZD5634 1692 µg|Participants received inhaled single doses of AZD5634 1692 µg under fasted conditions
11265593|NCT02679729|EG007|Reported Event|Part A - Placebo for AZD5634|2 participants per dose level received single dose of placebo in Part A
11265594|NCT02679729|EG008|Reported Event|Part B - AZD5634 IV 65 µg|Participants received IV dose of IV 65 µg
11265595|NCT02679729|EG009|Reported Event|Part B - AZD5634 IN 1692 µg|Participants received IV dose and after a washout period of 14 days this was followed by an inhaled dose AZD5634 1692 µg to the same participants
11265596|NCT02679755|BG000|Baseline|Palbociclib+Letrozole India Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265597|NCT02679755|BG001|Baseline|Palbociclib+Letrozole Australia Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
10970055|NCT00908596|OG002|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265598|NCT02679755|BG002|Baseline|Total|Total of all reporting groups
11265599|NCT02679755|FG000|Participant Flow|Palbociclib+Letrozole India Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265600|NCT02679755|FG001|Participant Flow|Palbociclib+Letrozole Australia Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265601|NCT02679755|OG000|Outcome|Palbociclib+Letrozole India Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265602|NCT02679755|OG001|Outcome|Palbociclib+Letrozole Australia Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265603|NCT02679755|OG002|Outcome|Palbociclib+LetrozoleTotal|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265604|NCT02679755|OG000|Outcome|Palbociclib+Letrozole India Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265605|NCT02679755|OG002|Outcome|Palbociclib+Letrozole Total|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265606|NCT02679755|EG000|Reported Event|Palbociclib+Letrozole India Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265607|NCT02679755|EG001|Reported Event|Palbociclib+Letrozole Australia Cohort|Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
11265608|NCT02679807|BG000|Baseline|Bifidobacterium Lactis Bl-04|"2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier~Bifidobacterium animalis subsp. lactis Bl-04"
11265609|NCT02679807|BG001|Baseline|Placebo|"sucrose~sucrose"
11265610|NCT02679807|BG002|Baseline|Total|Total of all reporting groups
11265611|NCT02679807|FG000|Participant Flow|Bifidobacterium Lactis Bl-04|"2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier~Bifidobacterium animalis subsp. lactis Bl-04"
11265612|NCT02679807|FG001|Participant Flow|Placebo|"sucrose~sucrose"
11265613|NCT02679807|OG000|Outcome|Bifidobacterium Lactis Bl-04|"2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier~Bifidobacterium animalis subsp. lactis Bl-04"
11265614|NCT02679807|OG001|Outcome|Placebo|"sucrose~sucrose"
11265615|NCT02679807|EG000|Reported Event|Bifidobacterium Lactis Bl-04|"2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier~Bifidobacterium animalis subsp. lactis Bl-04"
11265616|NCT02679807|EG001|Reported Event|Placebo|"sucrose~sucrose"
11265617|NCT02679911|BG000|Baseline|Loceryl NL + Ciclopirox NL|"Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.~Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed"
11265618|NCT02679911|FG000|Participant Flow|Loceryl NL and Ciclopirox NL|"Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.~Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed"
11265619|NCT02679911|OG000|Outcome|Loceryl NL|Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.
11265620|NCT02679911|OG001|Outcome|Ciclopirox NL|Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
11265621|NCT02679911|EG000|Reported Event|Loceryl NL + Ciclopirox NL|"Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.~Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed~Note: Adverse Events are not available for each intervention."
11265622|NCT02679976|BG000|Baseline|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11265623|NCT02679976|FG000|Participant Flow|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11265624|NCT02679976|OG000|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11265625|NCT02679976|OG001|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11265626|NCT02679976|EG000|Reported Event|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
11265627|NCT02680002|BG000|Baseline|7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
11265628|NCT02680002|BG001|Baseline|15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
11265629|NCT02680002|BG002|Baseline|7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265630|NCT02680002|BG003|Baseline|15 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265631|NCT02680002|BG004|Baseline|90 mcg H5N1 (Monobulk) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
11265632|NCT02680002|BG005|Baseline|90 mcg H5N1 (Vials) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
11265633|NCT02680002|BG006|Baseline|Total|Total of all reporting groups
11265634|NCT02680002|FG000|Participant Flow|7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
11265635|NCT02680002|FG001|Participant Flow|15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant MF59 adjuvant
11265636|NCT02680002|FG002|Participant Flow|7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)|"Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant~7.5 mcg H5N1 (stored as monobulk)~MF59"
11265637|NCT02680002|FG003|Participant Flow|15 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265638|NCT02680002|FG004|Participant Flow|90 mcg H5N1 (Monobulk) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
11265639|NCT02680002|FG005|Participant Flow|90 mcg H5N1 (Vials) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
11265640|NCT02680002|OG000|Outcome|7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
11265641|NCT02680002|OG001|Outcome|15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
11265642|NCT02680002|OG002|Outcome|7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265643|NCT02680002|OG003|Outcome|15 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265644|NCT02680002|OG004|Outcome|90 mcg H5N1 (Monobulk) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
11265645|NCT02680002|OG005|Outcome|90 mcg H5N1 (Vials) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
11265646|NCT02680002|OG002|Outcome|7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
11265647|NCT02680002|OG003|Outcome|15 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
11265648|NCT02680002|OG000|Outcome|7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/G5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
11265649|NCT02680002|EG000|Reported Event|7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
11265650|NCT02680002|EG001|Reported Event|15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
11265651|NCT02680002|EG002|Reported Event|7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265652|NCT02680002|EG003|Reported Event|15 mcg H5N1 (Monobulk) Plus MF59 (Vials)|Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
11265653|NCT02680002|EG004|Reported Event|90 mcg H5N1 (Monobulk) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
11265654|NCT02680002|EG005|Reported Event|90 mcg H5N1 (Vials) Without MF59|Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
11265655|NCT02680041|BG000|Baseline|18F-fluciclovine PET CT|Single intravenous administration of 18F-fluciclovine PET/CT.
11265656|NCT02680041|FG000|Participant Flow|18F-fluciclovine PET CT|Single intravenous administration of 18F-fluciclovine PET CT.
11265657|NCT02680041|OG000|Outcome|18F-fluciclovine PET CT|"Single intravenous administration of 18F-fluciclovine PET CT.~18F-fluciclovine PET CT: Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment"
11265658|NCT02680041|OG000|Outcome|18F-fluciclovine PET CT|Single intravenous administration of 18F-fluciclovine PET CT.
11265659|NCT02680041|EG000|Reported Event|18F-fluciclovine PET CT|Single intravenous administration of 18F-fluciclovine PET CT.
11286771|NCT02892422|FG000|Participant Flow|Lu AF35700 Flexible-dose|Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
11286772|NCT02892422|OG000|Outcome|Flexible-dose of Lu AF35700|Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
11286773|NCT02892422|EG000|Reported Event|Lu AF35700 Flexible-dose|Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
11286774|NCT02892448|BG000|Baseline|Unilateral Hip Resurfacing|"Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286775|NCT02892448|BG001|Baseline|Bilateral Hip Resurfacing|"Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286776|NCT02892448|BG002|Baseline|Non-Metal on Metal Total Hip|"Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286777|NCT02892448|BG003|Baseline|Total|Total of all reporting groups
11286778|NCT02892448|FG000|Participant Flow|Unilateral Hip Resurfacing|"Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286779|NCT02892448|FG001|Participant Flow|Bilateral Hip Resurfacing|"Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286780|NCT02892448|FG002|Participant Flow|Non-Metal on Metal Total Hip|"Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11337540|NCT03587207|BG002|Baseline|rMenBOMV+ACWY_D Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).
11265660|NCT02680054|BG000|Baseline|All Study Participants|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal, then +1hr, then +2hr. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265661|NCT02680054|FG000|Participant Flow|All Study Participants|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal, then +1hr after, then +2hr after. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265662|NCT02680054|OG000|Outcome|Arm 1 (Usual Treatment)|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265663|NCT02680054|OG001|Outcome|Arm 2|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265664|NCT02680054|OG002|Outcome|Arm 3|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265665|NCT02680054|OG000|Outcome|All Participants|All participants
11265666|NCT02680054|EG000|Reported Event|Arm 1 (Usual Treatment)|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265667|NCT02680054|EG001|Reported Event|Arm 2|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265668|NCT02680054|EG002|Reported Event|Arm 3|"Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child.~Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal"
11265669|NCT02680145|BG000|Baseline|Preoperative Pessary Use|"All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse~Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair"
11265670|NCT02680145|FG000|Participant Flow|Preoperative Pessary Use|"All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse~Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair"
11265671|NCT02680145|OG000|Outcome|Preoperative Pessary Use|"All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse~Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair"
11265672|NCT02680145|EG000|Reported Event|Preoperative Pessary Use|"All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse~Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair"
11265673|NCT02680158|BG000|Baseline|All Study Participants|All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0.
11265674|NCT02680158|FG000|Participant Flow|Sequence 1 - Intranasal : Extranasal : Sham|Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265675|NCT02680158|FG001|Participant Flow|Sequence 2 - Intranasal : Sham : Extranasal|Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265676|NCT02680158|FG002|Participant Flow|Sequence 3 - Extranasal: Intranasal: Sham|Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265677|NCT02680158|FG003|Participant Flow|Sequence 4 - Extranasal : Sham : Intranasal|Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265678|NCT02680158|FG004|Participant Flow|Sequence 5 - Sham : Intranasal : Extranasal|Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265679|NCT02680158|FG005|Participant Flow|Sequence 6 - Sham : Extranasal : Intranasal|Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
11265680|NCT02680158|OG000|Outcome|Oculeve Intranasal|Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0
11265681|NCT02680158|OG001|Outcome|Sham|Sham device (control), intranasal application for approximately 3 minutes on Day 0
11265682|NCT02680158|OG002|Outcome|Oculeve Extranasal|Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
11265683|NCT02680158|EG000|Reported Event|Oculeve Intranasal|Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0
11265684|NCT02680158|EG001|Reported Event|Sham|Sham device (control), intranasal application for approximately 3 minutes on Day 0
11265685|NCT02680158|EG002|Reported Event|Oculeve Extranasal|Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
11265686|NCT02680301|BG000|Baseline|Ointment Right/Cream Left|"Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on right side and 0.1% triamcinolone CREAM with wet-wrap dressing on left side of bilateral flare of atopic dermatitis twice daily as instructed.~0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.~0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique."
11265687|NCT02680301|BG001|Baseline|Ointment Left/Cream Right|"Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on left side and 0.1% triamcinolone CREAM with wet-wrap dressing on right side of bilateral flare of atopic dermatitis twice daily as instructed.~0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.~0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique."
11265688|NCT02680301|BG002|Baseline|Total|Total of all reporting groups
11265689|NCT02680301|FG000|Participant Flow|Ointment Right/Cream Left|"Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on right side and 0.1% triamcinolone CREAM with wet-wrap dressing on left side of bilateral flare of atopic dermatitis twice daily as instructed.~0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.~0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique."
11265690|NCT02680301|FG001|Participant Flow|Ointment Left/Cream Right|"Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on left side and 0.1% triamcinolone CREAM with wet-wrap dressing on right side of bilateral flare of atopic dermatitis twice daily as instructed.~0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.~0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique."
11265691|NCT02680301|OG000|Outcome|Cream|Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
11265692|NCT02680301|OG001|Outcome|Ointment|Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
10848155|NCT00288860|OG000|Outcome|Telephone Monitoring|"Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.~Telephone monitoring: Three months of biweekly telephone monitoring and support~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
11265693|NCT02680301|OG000|Outcome|All Subjects|All study participants
11265694|NCT02680301|EG000|Reported Event|Ointement|0.1% triamcinolone OINTMENT with wet-wrap dressing
11265695|NCT02680301|EG001|Reported Event|Cream|0.1% triamcinolone CREAM with wet-wrap dressing
11265696|NCT02680314|BG000|Baseline|Single Dose|"single dose of misoprostol~Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix."
11265697|NCT02680314|BG001|Baseline|Multiple Dose|"multiple doses of misoprostol~Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix."
11265698|NCT02680314|BG002|Baseline|Total|Total of all reporting groups
11265699|NCT02680314|FG000|Participant Flow|Single Dose|single dose of misoprostol
11265700|NCT02680314|FG001|Participant Flow|Multiple Dose|multiple doses of misoprostol
11265701|NCT02680314|OG000|Outcome|Single Dose|single dose of misoprostol
11265702|NCT02680314|OG001|Outcome|Multiple Dose|multiple doses of misoprostol
11265703|NCT02680314|EG000|Reported Event|Single Dose|single dose of misoprostol
11265704|NCT02680314|EG001|Reported Event|Multiple Dose|multiple doses of misoprostol
11265705|NCT02680457|BG000|Baseline|Insulin Total Group|Total Group of Patients with Type 2 Diabetes mellitus
11265706|NCT02680457|FG000|Participant Flow|Insulin Degludec - Insulin Glargine|Insulin Degludec: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days
11265707|NCT02680457|FG001|Participant Flow|Insulin Glargine - Insulin Degludec|Insulin Glargine: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days
11265708|NCT02680457|OG000|Outcome|Insulin Degludec|"Patients who received:~Insulin Degludec: 10 IU SC every 24 hours for 6 days, from both arms of the study"
11265709|NCT02680457|OG001|Outcome|Insulin Glargine|"Patients who received:~Insulin Glargine: 10 IU SC every 24 hours for 6 days, from both arms of the study"
11265710|NCT02680457|EG000|Reported Event|Insulin Degludec|"Patients with Type 2 Diabetes mellitus~Insulin Degludec: 10 IU SC every 24 hours for 6 days"
11265711|NCT02680457|EG001|Reported Event|Insulin Glargine|"Patients with Type 2 Diabetes mellitus~Insulin Glargine: 10 IU SC every 24 hours for 6 days"
11265712|NCT02680639|BG000|Baseline|All Participants|All participants that signed consent.
11265713|NCT02680639|FG000|Participant Flow|Screening Period|All study participants that were consented to the study.
11265714|NCT02680639|FG001|Participant Flow|Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P|Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - non-optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - Optimized EPAP w/ no peak-to-peak last
11265715|NCT02680639|FG002|Participant Flow|Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized NP2P|Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - Non-Optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - optimized EPAP w/ no peak-to-peak last
11265716|NCT02680639|OG000|Outcome|Optimal EPAP Determination|"On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes expiratory flow limitation (EFL). Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)~BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in."
11265717|NCT02680639|OG001|Outcome|Optimized EPAP w/ no Peak-to-peak|"On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)~BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in."
11265718|NCT02680639|OG002|Outcome|Optimized EPAP w/ Max Peak-to-peak|"On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)~BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in."
11265719|NCT02680639|OG003|Outcome|Non-optimized EPAP w/ no Peak-to-peak|"On the BiPAP Synchrony ventilator EPAP will be set at 4cmH2O and IPAP will be set at 10cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).~BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in."
11265720|NCT02680639|OG000|Outcome|Optimal EPAP Determination|"On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes EFL. Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)~BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in."
11265721|NCT02680639|EG000|Reported Event|Screening Period|All study participants that were consented to the study.
11265722|NCT02680639|EG001|Reported Event|Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P|Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - non-optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - Optimized EPAP w/ no peak-to-peak last
11265723|NCT02680639|EG002|Reported Event|Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized P2P|Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - Non-Optimized EPAP w/ no peak-to-pea third, and Optimized P2P - optimized EPAP w/ peak-to-peak last
11265724|NCT02680665|BG000|Baseline|AMEPAROMO Capsules (Paromomycin)|Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion.
11265725|NCT02680665|FG000|Participant Flow|AMEPAROMO Capsules (Paromomycin)|Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion.
11265726|NCT02680665|OG000|Outcome|AMEPAROMO Capsules (Paromomycin)|Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion.
11265727|NCT02680665|EG000|Reported Event|AMEPAROMO Capsules (Paromomycin)|Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion.
11265728|NCT02680756|BG000|Baseline|Oral Ferric Iron Compound|"30 mg capsules to be taken orally twice a day~Ferric Maltol"
11265729|NCT02680756|BG001|Baseline|Intravenous Iron|"Administered as per the local SmPC/PI~Ferric Carboxymaltose"
11265730|NCT02680756|BG002|Baseline|Total|Total of all reporting groups
11265731|NCT02680756|FG000|Participant Flow|Oral Ferric Iron Compound|"30 mg capsules to be taken orally twice a day~Ferric Maltol"
11265732|NCT02680756|FG001|Participant Flow|Intravenous Iron|"Administered as per the local SmPC/PI~Ferric Carboxymaltose"
11265733|NCT02680756|OG000|Outcome|Oral Ferric Iron Compound|"30 mg capsules to be taken orally twice a day~Ferric Maltol"
11265734|NCT02680756|OG001|Outcome|Intravenous Iron|"Administered as per the local SmPC/PI~Ferric Carboxymaltose"
11265735|NCT02680756|EG000|Reported Event|Oral Ferric Iron Compound|"30 mg capsules to be taken orally twice a day~Ferric Maltol"
11265736|NCT02680756|EG001|Reported Event|Intravenous Iron|"Administered as per the local SmPC/PI~Ferric Carboxymaltose"
11265737|NCT02680834|BG000|Baseline|Dual Action Pneumatic Compression Device|"ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.~Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs."
11265738|NCT02680834|BG001|Baseline|Multi-layer Bandaging|"PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.~Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs"
11265739|NCT02680834|BG002|Baseline|Total|Total of all reporting groups
11265740|NCT02680834|FG000|Participant Flow|Dual Action Pneumatic Compression Device|"ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.~Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs."
11265741|NCT02680834|FG001|Participant Flow|Multi-layer Bandaging|"PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.~Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs"
11265742|NCT02680834|OG000|Outcome|Dual Action Pneumatic Compression Device|"ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.~Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs."
11265743|NCT02680834|OG001|Outcome|Multi-layer Bandaging|"PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.~Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs"
11265744|NCT02680834|EG000|Reported Event|Dual Action Pneumatic Compression Device|"ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.~Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs."
11265745|NCT02680834|EG001|Reported Event|Multi-layer Bandaging|"PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.~Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs"
11265746|NCT02680847|BG000|Baseline|ALO-02 <=20 mg|Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265747|NCT02680847|BG001|Baseline|ALO-02 >20-40 mg|Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265748|NCT02680847|BG002|Baseline|ALO-02 >40-80 mg|Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265749|NCT02680847|BG003|Baseline|Total|Total of all reporting groups
11265750|NCT02680847|FG000|Participant Flow|ALO-02 <=20 mg|Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265751|NCT02680847|FG001|Participant Flow|ALO-02 >20-40 mg|Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265752|NCT02680847|FG002|Participant Flow|ALO-02 >40-80 mg|Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265753|NCT02680847|OG000|Outcome|ALO-02 <= 20 mg|Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265754|NCT02680847|OG001|Outcome|ALO-02 >20-40 mg|Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265755|NCT02680847|OG002|Outcome|ALO-02 >40-80 mg|Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265756|NCT02680847|EG000|Reported Event|ALO-02 <=20 mg|Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265757|NCT02680847|EG001|Reported Event|ALO-02 >20-40 mg|Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265758|NCT02680847|EG002|Reported Event|ALO-02 >40-80 mg|Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
11265759|NCT02681094|BG000|Baseline|Dapagliflozin + Saxagliptin + Metformin|Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
11265760|NCT02681094|BG001|Baseline|Dapagliflozin + Metformin|Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
11265761|NCT02681094|BG002|Baseline|Saxagliptin + Metformin|Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
11265762|NCT02681094|BG003|Baseline|Total|Total of all reporting groups
11265763|NCT02681094|FG000|Participant Flow|Dapagliflozin + Saxagliptin + Metformin|Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
11265764|NCT02681094|FG001|Participant Flow|Dapagliflozin + Metformin|Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
11265765|NCT02681094|FG002|Participant Flow|Saxagliptin + Metformin|Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
11265766|NCT02681094|OG000|Outcome|Dapagliflozin + Saxagliptin + Metformin|Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
11265767|NCT02681094|OG001|Outcome|Dapagliflozin + Metformin|Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
11265768|NCT02681094|OG002|Outcome|Saxagliptin + Metformin|Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
11265769|NCT02681094|OG001|Outcome|Saxagliptin + Metformin|Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
11265770|NCT02681094|EG000|Reported Event|Dapagliflozin + Saxagliptin + Metformin|Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
11265771|NCT02681094|EG001|Reported Event|Dapagliflozin + Metformin|Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
11265772|NCT02681094|EG002|Reported Event|Saxagliptin + Metformin|Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
11265773|NCT02681172|BG000|Baseline|Neuraceq (Florbetaben 18F) PET Scan|A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. PET: A brain PET scan was taken 90 minutes after the i.v. injection of florbetaben 18F.
11265774|NCT02681172|FG000|Participant Flow|Neuraceq (Florbetaben 18F) PET Scan|A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. PET: A brain PET scan was taken 90 minutes after the i.v. injection of florbetaben 18F.
11265775|NCT02681172|OG000|Outcome|Safety Analysis Set|All subjects who received any amount of florbetaben were included.
11265776|NCT02681172|EG000|Reported Event|Safety Analysis Set|All subjects who received any amount of florbetaben were included.
11265777|NCT02681458|BG000|Baseline|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265778|NCT02681458|BG001|Baseline|Non-drug Users|"Control group that consisted of non drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265779|NCT02681458|BG002|Baseline|Total|Total of all reporting groups
11265780|NCT02681458|FG000|Participant Flow|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265781|NCT02681458|FG001|Participant Flow|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265782|NCT02681458|OG000|Outcome|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265783|NCT02681458|OG001|Outcome|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265784|NCT02681458|EG000|Reported Event|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265785|NCT02681458|EG001|Reported Event|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
11265786|NCT02681510|BG000|Baseline|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11265787|NCT02681510|FG000|Participant Flow|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11265788|NCT02681510|OG000|Outcome|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11265789|NCT02681510|EG000|Reported Event|Three Drug Intervention|Varenicline, nicotine patch and nicotine lozenge for 12 weeks
11265790|NCT02681523|BG000|Baseline|Single Arm Study|3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
11265791|NCT02681523|FG000|Participant Flow|Single Arm Study|3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This was then followed by 9 weeks of an Aromatase Inhibitor (AI) treatment (either letrozole, exemestane or anastrozole), followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients remained on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever was sooner.
11265792|NCT02681523|OG000|Outcome|Single Arm Study|3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
11265793|NCT02681523|EG000|Reported Event|Single Arm Study|3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
11265799|NCT02681757|BG000|Baseline|Control- Triple Antibiotic Ointment|"triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~triple antibiotic ointment dressing: used for control group under soft cast"
11265800|NCT02681757|BG001|Baseline|Variable- Mepitel Ag|"mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~Mepitel Ag: used for variable/experimental group under soft cast"
11265801|NCT02681757|BG002|Baseline|Total|Total of all reporting groups
11265802|NCT02681757|FG000|Participant Flow|Control- Triple Antibiotic Ointment|"triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~triple antibiotic ointment dressing: used for control group under soft cast"
11265803|NCT02681757|FG001|Participant Flow|Variable- Mepitel Ag|"mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~Mepitel Ag: used for variable/experimental group under soft cast"
11265804|NCT02681757|OG000|Outcome|Control- Triple Antibiotic Ointment|"triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~triple antibiotic ointment dressing: used for control group under soft cast"
11265805|NCT02681757|OG001|Outcome|Variable- Mepitel Ag|"mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~Mepitel Ag: used for variable/experimental group under soft cast"
11265806|NCT02681757|EG000|Reported Event|Control- Triple Antibiotic Ointment|"triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~triple antibiotic ointment dressing: used for control group under soft cast"
11265807|NCT02681757|EG001|Reported Event|Variable- Mepitel Ag|"mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban~Mepitel Ag: used for variable/experimental group under soft cast"
11265808|NCT02681809|BG000|Baseline|Ocriplasmin 0.0625mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
11265809|NCT02681809|BG001|Baseline|Ocriplasmin 0.125mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
11265810|NCT02681809|BG002|Baseline|Sham Injection|Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
11265811|NCT02681809|BG003|Baseline|Total|Total of all reporting groups
11265812|NCT02681809|FG000|Participant Flow|Ocriplasmin 0.0625mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
11265813|NCT02681809|FG001|Participant Flow|Ocriplasmin 0.125mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
11265814|NCT02681809|FG002|Participant Flow|Sham Injection|Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
11265815|NCT02681809|OG000|Outcome|Ocriplasmin 0.0625mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
11265816|NCT02681809|OG001|Outcome|Ocriplasmin 0.125mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
11265817|NCT02681809|OG002|Outcome|Sham Injection|Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
11265818|NCT02681809|EG000|Reported Event|Ocriplasmin 0.0625mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
11265819|NCT02681809|EG001|Reported Event|Ocriplasmin 0.125mg|Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
11265820|NCT02681809|EG002|Reported Event|Sham Injection|Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
11265821|NCT02682030|BG000|Baseline|Treatment Group A HFCC Only|"Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area."
11265822|NCT02682030|BG001|Baseline|Treatment Group B HFCC + Cough Assist|"Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.~Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing."
11265823|NCT02682030|BG002|Baseline|Total|Total of all reporting groups
11265824|NCT02682030|FG000|Participant Flow|Treatment Group A - HFCC Only|"Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area."
10848156|NCT00288860|OG001|Outcome|Treatment-As-Usual|"Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
11265825|NCT02682030|FG001|Participant Flow|Treatment Group B- HFCC and Cough Assist|"Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.~Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing."
11265826|NCT02682030|OG000|Outcome|Treatment Group A|"Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area."
11265827|NCT02682030|OG001|Outcome|Treatment Group B- HFCC and Cough Assist|"Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.~Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing."
11265828|NCT02682030|OG000|Outcome|Treatment Group A - HFCC Only|"Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area."
11265829|NCT02682030|EG000|Reported Event|Treatment Group A - HFCC Only|"Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area."
11265830|NCT02682030|EG001|Reported Event|Treatment Group B- HFCC and Cough Assist|"Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.~High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.~Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing."
11265831|NCT02682056|BG000|Baseline|Children Having Glucose Levels Tested Through Three Methods|Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.
11265832|NCT02682056|FG000|Participant Flow|Children Having Glucose Levels Tested Through Three Methods|Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. Sample collection with the different methods will occur simultaneously four times, on an hourly basis, during a single study visit.
11265833|NCT02682056|OG000|Outcome|Microneedle|Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265834|NCT02682056|OG001|Outcome|Lancet|Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265835|NCT02682056|OG002|Outcome|Intravenous Catheter|Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265836|NCT02682056|EG000|Reported Event|Microneedle|Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265837|NCT02682056|EG001|Reported Event|Lancet|Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265838|NCT02682056|EG002|Reported Event|Intravenous Catheter|Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit.
11265839|NCT02682069|BG000|Baseline|All Patients|There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.MolecuLight i:X Imaging Device: The intended use of the device is to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device will be used as part of the current clinical wound assessment process which may include examination for characteristic signs and symptoms of infection. The device can capture and document either an image or video of the chronic wound where the presence of florescent bacteria appears under violet light illumination.
11265840|NCT02682069|FG000|Participant Flow|All Patients|There is one arm to this study and all patients will undergo the same procedures.The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations.Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
11265841|NCT02682069|OG000|Outcome|All Patients|There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
11265842|NCT02682069|EG000|Reported Event|All Patients (Imaging/no Intervention)|There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
11265843|NCT02682264|BG000|Baseline|CB-03-01 Cream, 1%|"Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11265844|NCT02682264|BG001|Baseline|CB-03-01 Cream, 1% (Vehicle Arm)|Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
11265845|NCT02682264|BG002|Baseline|Total|Total of all reporting groups
11265846|NCT02682264|FG000|Participant Flow|CB-03-01 Cream, 1%|"Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris."
11265847|NCT02682264|FG001|Participant Flow|CB-03-01 Cream, 1% (Vehicle Arm)|Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
11265848|NCT02682264|OG000|Outcome|CB-03-01 Cream, 1%|"Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11265849|NCT02682264|OG001|Outcome|CB-03-01 Cream, 1% (Vehicle Arm)|Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
11265850|NCT02682264|EG000|Reported Event|CB-03-01 Cream, 1%|"Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.~Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a~1% cream for the topical treatment of acne vulgaris."
11265851|NCT02682264|EG001|Reported Event|CB-03-01 Cream, 1% (Vehicle Arm)|Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
11265852|NCT02682381|BG000|Baseline|0.025 mg/kg/Day Teduglutide|Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265853|NCT02682381|BG001|Baseline|0.05 mg/kg/Day Teduglutide|Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265854|NCT02682381|BG002|Baseline|Standard of Care|Participants received standard medical therapy.
11265855|NCT02682381|BG003|Baseline|Total|Total of all reporting groups
11265856|NCT02682381|FG000|Participant Flow|0.025 mg/kg/Day Teduglutide|Participants received 0.025 milligram per kilogram per day (mg/kg/day) of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265857|NCT02682381|FG001|Participant Flow|0.05 mg/kg/Day Teduglutide|Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265858|NCT02682381|FG002|Participant Flow|Standard of Care|Participants received standard medical therapy.
11265859|NCT02682381|OG000|Outcome|0.025 mg/kg/Day Teduglutide|Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265860|NCT02682381|OG001|Outcome|0.05 mg/kg/Day Teduglutide|Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265861|NCT02682381|OG002|Outcome|Standard of Care|Participants received standard medical therapy.
11265862|NCT02682381|EG000|Reported Event|0.025 mg/kg/Day Teduglutide|Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265863|NCT02682381|EG001|Reported Event|0.05 mg/kg/Day Teduglutide|Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
11265864|NCT02682381|EG002|Reported Event|Standard of Care|Participants received standard medical therapy.
11265865|NCT02682420|BG000|Baseline|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11265866|NCT02682420|FG000|Participant Flow|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11265867|NCT02682420|OG000|Outcome|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
10848157|NCT00288860|EG000|Reported Event|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
11265868|NCT02682420|OG000|Outcome|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11265869|NCT02682420|OG000|Outcome|At 1 Month|Participants that have met the definition for maturity by the 1 Month follow-up visit
11265870|NCT02682420|OG001|Outcome|At 3 Months|Participants that have met the definition for maturity by the 3 Month follow-up visit
11265871|NCT02682420|OG002|Outcome|At 6 Months|Participants that have met the definition for maturity by the 6 Month follow-up visit
11265872|NCT02682420|OG003|Outcome|At Any Visit|Participants that have met the definition for maturity at any visit
11265873|NCT02682420|OG000|Outcome|At 1 Month|Participants that were not on dialysis at the time of endoAVF creation and were catheter-free at 30 days of follow-up
11265874|NCT02682420|OG001|Outcome|At 6 Months|Participants that were not on dialysis at the time of endoAVF creation and were catheter-free at 180 days of follow-up
11265875|NCT02682420|EG000|Reported Event|endoAVF|everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
11265876|NCT02682498|BG000|Baseline|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11265877|NCT02682498|BG001|Baseline|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11265878|NCT02682498|BG002|Baseline|Total|Total of all reporting groups
11265879|NCT02682498|FG000|Participant Flow|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11265880|NCT02682498|FG001|Participant Flow|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11265881|NCT02682498|OG000|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11265882|NCT02682498|OG001|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11265883|NCT02682498|OG001|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
11265884|NCT02682498|EG000|Reported Event|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.~(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
11265885|NCT02682498|EG001|Reported Event|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
11265886|NCT02682563|BG000|Baseline|Dapagliflozin 10mg Once Daily|"Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks.~Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks"
11265887|NCT02682563|BG001|Baseline|Gliclazide Modified Release 30mg Once Daily|"Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks.~Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks"
11265888|NCT02682563|BG002|Baseline|Total|Total of all reporting groups
11265889|NCT02682563|FG000|Participant Flow|Dapagliflozin 10mg Once Daily|"Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks.~Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks"
11265890|NCT02682563|FG001|Participant Flow|Gliclazide Modified Release 30mg Once Daily|"Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks.~Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks"
11265891|NCT02682563|OG000|Outcome|Dapagliflozin 10mg Once Daily|"Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks.~Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks"
11265892|NCT02682563|OG001|Outcome|Gliclazide Modified Release 30mg Once Daily|"Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks.~Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks"
11265893|NCT02682563|EG000|Reported Event|Dapagliflozin 10mg Once Daily|"Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks.~Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks"
11265894|NCT02682563|EG001|Reported Event|Gliclazide Modified Release 30mg Once Daily|"Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks.~Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks"
11265895|NCT02682602|BG000|Baseline|Diseased/Implanted Hip|Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265896|NCT02682602|BG001|Baseline|Normal Hip|Subjects with a normal hip.
11265897|NCT02682602|BG002|Baseline|Total|Total of all reporting groups
11265898|NCT02682602|FG000|Participant Flow|Diseased/Implanted Hip|Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265899|NCT02682602|FG001|Participant Flow|Normal Hip|Subjects with a normal hip.
11265900|NCT02682602|OG000|Outcome|Diseased Hip (Baseline)|Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265901|NCT02682602|OG001|Outcome|Normal Hip|Subjects with a normal hip.
11265902|NCT02682602|OG002|Outcome|Implanted Hip|Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265903|NCT02682602|OG002|Outcome|Implanted Hip|Diseased hip subjects who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265904|NCT02682602|OG002|Outcome|Implanted Hip|Diseased subjects who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265905|NCT02682602|EG000|Reported Event|Diseased Hip|Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
11265906|NCT02682602|EG001|Reported Event|Normal Hip|Subjects will have a normal hip.
11265907|NCT02682602|EG002|Reported Event|Implanted Group|Diseased hip subjects who were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA
11265908|NCT02682784|BG000|Baseline|Oxytocin/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265909|NCT02682784|BG001|Baseline|Placebo/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to placebo.~Placebo"
11265910|NCT02682784|BG002|Baseline|Oxytocin/Control|"Healthy controls who are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265911|NCT02682784|BG003|Baseline|Placebo/Control|"Healthy controls who are randomized to placebo.~Placebo"
11265912|NCT02682784|BG004|Baseline|Total|Total of all reporting groups
10848158|NCT00288860|EG001|Reported Event|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
11265913|NCT02682784|FG000|Participant Flow|Oxytocin/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265914|NCT02682784|FG001|Participant Flow|Placebo/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to placebo.~Placebo"
11265915|NCT02682784|FG002|Participant Flow|Oxytocin/Control|"Healthy controls who are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265916|NCT02682784|FG003|Participant Flow|Placebo/Control|"Healthy controls who are randomized to placebo.~Placebo"
11265917|NCT02682784|OG000|Outcome|Oxytocin/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265918|NCT02682784|OG001|Outcome|Placebo/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to placebo.~Placebo"
11265919|NCT02682784|OG002|Outcome|Oxytocin/Control|"Healthy controls who are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265920|NCT02682784|OG003|Outcome|Placebo/Control|"Healthy controls who are randomized to placebo.~Placebo"
11265921|NCT02682784|EG000|Reported Event|Oxytocin/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265922|NCT02682784|EG001|Reported Event|Placebo/Cocaine User|"Individuals who meet criteria for cocaine use disorder and are randomized to placebo.~Placebo"
11265923|NCT02682784|EG002|Reported Event|Oxytocin/Control|"Healthy controls who are randomized to oxytocin.~Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin."
11265924|NCT02682784|EG003|Reported Event|Placebo/Control|"Healthy controls who are randomized to placebo.~Placebo"
11265925|NCT02682823|BG000|Baseline|Caregivers|CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265926|NCT02682823|BG001|Baseline|Healthcare Professionals|HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265927|NCT02682823|BG002|Baseline|RA Group 1 (Self-Administration)|Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265928|NCT02682823|BG003|Baseline|RA Group 2 (Administration by CG)|CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265929|NCT02682823|BG004|Baseline|RA Group 3 (Administration by HCP)|HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
11265930|NCT02682823|BG005|Baseline|Total|Total of all reporting groups
11265931|NCT02682823|FG000|Participant Flow|Caregivers|Caregivers (CGs) performed injection of 162 milligrams (mg) subcutaneous (SC) tocilizumab to a subset of participants with rheumatoid arthritis (RA) using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265932|NCT02682823|FG001|Participant Flow|Healthcare Professionals|Healthcare professionals (HCPs) performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265933|NCT02682823|FG002|Participant Flow|RA Group 1 (Self-Administration)|Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265934|NCT02682823|FG003|Participant Flow|RA Group 2 (Administration by CG)|CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265935|NCT02682823|FG004|Participant Flow|RA Group 3 (Administration by HCP)|HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
11265936|NCT02682823|OG000|Outcome|RA Group 1 (Self-Administration)|Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265937|NCT02682823|OG001|Outcome|Caregivers|CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265938|NCT02682823|OG002|Outcome|Healthcare Professionals|HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265939|NCT02682823|OG001|Outcome|RA Group 2 (Administration by CG)|CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265940|NCT02682823|OG002|Outcome|RA Group 3 (Administration by HCP)|HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
11265941|NCT02682823|OG003|Outcome|RA Group 2 (Administration by CG)|CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265942|NCT02682823|OG004|Outcome|RA Group 3 (Administration by HCP)|HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
11265943|NCT02682823|EG000|Reported Event|RA Group 1 (Self-Administration)|Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265944|NCT02682823|EG001|Reported Event|RA Group 2 (Administration by CG)|CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
11265945|NCT02682823|EG002|Reported Event|RA Group 3 (Administration by HCP)|HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
10970056|NCT00908596|OG003|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265946|NCT02683083|BG000|Baseline|[131I]-SGMIB Anti-HER2 VHH1|All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).
11265947|NCT02683083|FG000|Participant Flow|[131I]-SGMIB Anti-HER2 VHH1|All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).
11265948|NCT02683083|OG000|Outcome|[131I]-SGMIB Anti-HER2 VHH1|All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).
11265949|NCT02683083|EG000|Reported Event|[131I]-SGMIB Anti-HER2 VHH1|All subjects received one single intravenous injection of the investigational medical product ([131I]-SGMIB Anti-HER2 VHH1).
11265950|NCT02683109|BG000|Baseline|T+O 5/5|"The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler.~Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler."
11265951|NCT02683109|BG001|Baseline|T 5/O 5|The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol.
11265952|NCT02683109|BG002|Baseline|Total|Total of all reporting groups
11265953|NCT02683109|FG000|Participant Flow|T+O 5/5|"The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler.~Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler."
11265954|NCT02683109|FG001|Participant Flow|T 5/O 5|The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol.
11265955|NCT02683109|OG000|Outcome|T+O 5/5|"The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler.~Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler."
11265956|NCT02683109|OG001|Outcome|T 5/O 5|The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol.
11265957|NCT02683109|EG000|Reported Event|T+O 5/5|"The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler.~Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler."
11265958|NCT02683109|EG001|Reported Event|T 5/O 5|The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol.
11265959|NCT02683109|EG002|Reported Event|Total|The total number of subjects who were administered T+O 5/5 or T 5/O 5.
11265960|NCT02683161|BG000|Baseline|Open-label Trial|Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery.
11265961|NCT02683161|FG000|Participant Flow|Open-label Trial|Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery.
11265962|NCT02683161|OG000|Outcome|Open-label Group|Participants received clinically-indicated dose of varenicline for smoking cessation.
11265963|NCT02683161|EG000|Reported Event|Open-label Trial|Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery.
11265964|NCT02683174|BG000|Baseline|Single Study Arm|"All enrolled patients will be fitted with a novel ambulatory patch (ZIO®Patch), which continuously records heartbeats for up to 14 days. Brain natriuretic peptide (BNP) and hs-troponin I at 0 and 3 hours post ED attendance~Novel ambulatory patch (ZIO® XT Patch): All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)~BNP and hs-troponin I at 0 and 3 hours post ED attendance: All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance."
11265965|NCT02683174|FG000|Participant Flow|Single Study Arm|"All enrolled patients will be fitted with a novel ambulatory patch (ZIO®Patch), which continuously records heartbeats for up to 14 days. Brain natriuretic peptide (BNP) and hs-troponin I at 0 and 3 hours post ED attendance~Novel ambulatory patch (ZIO® XT Patch): All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)~BNP and hs-troponin I at 0 and 3 hours post ED attendance: All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance."
11265966|NCT02683174|OG000|Outcome|Study Group|Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
11265967|NCT02683174|OG000|Outcome|Single Study Arm|"All enrolled patients will be fitted with a novel ambulatory patch (ZIO®Patch), which continuously records heartbeats for up to 14 days. Brain natriuretic peptide (BNP) and hs-troponin I at 0 and 3 hours post ED attendance~Novel ambulatory patch (ZIO® XT Patch): All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)~BNP and hs-troponin I at 0 and 3 hours post ED attendance: All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance."
10970057|NCT00908596|EG000|Reported Event|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11265968|NCT02683174|EG000|Reported Event|Study Arm|All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)
11337541|NCT03587207|BG003|Baseline|rMenBOMV Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).
11265969|NCT02683187|BG000|Baseline|Sitagliptin and Non-Sitagliptin Recipients|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff.~Active Comparator: Sitagliptin: Subjects will receive sitagliptin prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time).~Placebo Comparator - No Sitagliptin: Subjects will receive Placebo (instead of sitagliptin) prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265970|NCT02683187|FG000|Participant Flow|Sitagliptin and Non-Sitagliptin|"Arms of study per sequence:~1. Sitagliptin and Ex-9 then Saline then Non-Sitagliptin and Ex-9 then Saline 2. Sitagliptin and Saline then Ex-9 then Non-Sitagliptin and Ex-9 then Saline 3. Sitagliptin and Ex-9 then Saline then Non-Sitagliptin and Saline then Ex-9 4. Sitagliptin and Saline then Ex-9 then Non-Sitagliptin and Saline then Ex-9 5. Non-Sitagliptin and Ex-9 then Saline then Sitagliptin and Ex-9 then Saline 6. Non-Sitagliptin and Ex-9 then Saline then Sitagliptin and Saline then Ex-9 7. Non-Sitagliptin and Saline then Ex-9 then Sitagliptin and Ex-9 then Saline 8. Non-Sitagliptin and Saline then Ex-9 then Sitagliptin and Saline then Ex-9~."
11265971|NCT02683187|OG000|Outcome|Sitagliptin and Ex-9/Saline (Non-diabetics)|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, Sitagliptin will be administered.~Active Comparator: Sitagliptin: Subjects will receive sitagliptin prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265972|NCT02683187|OG001|Outcome|Sitagliptin and Ex-9/Saline (Diabetics)|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, Sitagliptin will be administered.~Active Comparator: Sitagliptin: Subjects will receive sitagliptin prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265973|NCT02683187|OG002|Outcome|Non-Sitagliptin and Ex-9/Saline (Non-diabetics)|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, placebo will be administered~Placebo Comparator - No Sitagliptin: Subjects will receive Placebo (instead of sitagliptin) prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265974|NCT02683187|OG003|Outcome|Non-Sitagliptin and Ex-9/Saline (Diabetics)|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, placebo will be administered~Placebo Comparator - No Sitagliptin: Subjects will receive Placebo (instead of sitagliptin) prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265975|NCT02683187|EG000|Reported Event|Sitagliptin|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, Sitagliptin will be administered.~Active Comparator: Sitagliptin: Subjects will receive sitagliptin prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265976|NCT02683187|EG001|Reported Event|Non-Sitagliptin|"The infusion procedures performed during study visits 2 and 3 are identical except that the oral medicine Sitagliptin will only be administered at one of the two visits, with order of Sitagliptin administration determined at random by study staff. In this arm, placebo will be administered~Placebo Comparator - No Sitagliptin: Subjects will receive Placebo (instead of sitagliptin) prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time)."
11265977|NCT02683421|BG000|Baseline|Control Subjects: 50 mcg/20 mCi Dose|"Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265978|NCT02683421|BG001|Baseline|Control Subjects: 200 mcg/2 mCi Dose|"Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265979|NCT02683421|BG002|Baseline|RA Subjects: 50 mcg/2 mCi Dose|"RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265980|NCT02683421|BG003|Baseline|RA Subjects: 200 mcg/2 mCi Dose|"RA group:200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265981|NCT02683421|BG004|Baseline|Total|Total of all reporting groups
11265982|NCT02683421|FG000|Participant Flow|Control Subjects: 50 mcg/2 mCi Dose|"Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m~Tilmanocept"
11265983|NCT02683421|FG001|Participant Flow|Controls Subjects: 200 mcg/2mCi Dose|"Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265984|NCT02683421|FG002|Participant Flow|RA Subjects: 50 mcg/2 mCi Dose|"Rheumatoid arthritis (RA) Group: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265985|NCT02683421|FG003|Participant Flow|RA Subjects: 200 mcg/2 mCi Dose|"RA group:200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265986|NCT02683421|OG000|Outcome|Control Subjects: 50 mcg/2 mCi Dose|"Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265987|NCT02683421|OG001|Outcome|Control Subjects: 200 mcg/2 mCi Dose|"Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265988|NCT02683421|OG002|Outcome|RA Subjects: 50 mcg/2 mCi Dose|"RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265989|NCT02683421|OG003|Outcome|RA Subjects: 200 mcg/2 mCi Dose|"RA group:200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265990|NCT02683421|EG000|Reported Event|Cohort 1|"Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265991|NCT02683421|EG001|Reported Event|Cohort 2|"Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265992|NCT02683421|EG002|Reported Event|Cohort 3|"RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265993|NCT02683421|EG003|Reported Event|Cohort 4|"RA group:200 mcg tilmanocept with 2 mCi Tc 99m~Tilmanocept"
11265994|NCT02683525|BG000|Baseline|Sitagliptin|"Sitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.~Sitagliptin: 600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant"
11265995|NCT02683525|FG000|Participant Flow|Sitagliptin|"Sitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.~Sitagliptin: 600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant"
11265996|NCT02683525|OG000|Outcome|Sitagliptin|"Sitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.~Sitagliptin: 600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant"
11265997|NCT02683525|EG000|Reported Event|Sitagliptin|"Sitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.~Sitagliptin: 600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant"
11265998|NCT02683577|BG000|Baseline|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11265999|NCT02683577|BG001|Baseline|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266000|NCT02683577|BG002|Baseline|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266001|NCT02683577|BG003|Baseline|Total Title|
11266002|NCT02683577|FG000|Participant Flow|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266003|NCT02683577|FG001|Participant Flow|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266004|NCT02683577|FG002|Participant Flow|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266005|NCT02683577|OG000|Outcome|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266006|NCT02683577|OG001|Outcome|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266007|NCT02683577|OG002|Outcome|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266008|NCT02683577|OG003|Outcome|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11266009|NCT02683577|EG000|Reported Event|Healthy Control|"Subjects in the healthy control group were assessed as having normal hepatic function.~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266010|NCT02683577|EG001|Reported Event|Mild HI|"Subjects in the mild HI group were assessed as C-P class A (5 to 6 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266011|NCT02683577|EG002|Reported Event|Moderate HI|"Subjects in the moderate HI group were assessed as C-P class B (7 to 9 points on C-P scale for classification of the severity of liver disease).~All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1."
11266012|NCT02683577|EG003|Reported Event|All HI|The all HI group represented all subjects in either HI group (mild + moderate). All subjects in each study group received a single oral dose of telotristat ethyl hippurate 500 mg (2x250 mg) on Day 1.
11266013|NCT02683668|BG000|Baseline|All Participant|Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use.
11266014|NCT02683668|FG000|Participant Flow|Handihaler-Tiotropium 18 mcg Untrained|"Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria~Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler"
11266015|NCT02683668|FG001|Participant Flow|Handihaler-Tiotropium 18 mcg Trained|"Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)~Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment"
11266016|NCT02683668|FG002|Participant Flow|Respimat-Tiotropium 5 mcg Trained|"Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.~Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment"
11266017|NCT02683668|OG000|Outcome|Handihaler-Tiotropium 18 mcg Untrained|"Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria~Handihaler-Tiotropium 18 mcg untrained: We are looking at the untrained used of Handihaler"
11266018|NCT02683668|OG001|Outcome|Handihaler-Tiotropium 18 mcg Trained|"Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)~Handihaler-Tiotropium 18 mcg trained: We are looking at the trained use of Handihaler after 14 days treatment"
11266019|NCT02683668|OG002|Outcome|Respimat-Tiotropium 5 mcg Trained|"Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.~Respimat-Tiotropium 5 mcg trained: we are looking at the trained use of Respimat after 14 days treatment"
11266020|NCT02683668|EG000|Reported Event|All Participant|Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use.
11266021|NCT02683707|BG000|Baseline|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266022|NCT02683707|BG001|Baseline|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266023|NCT02683707|BG002|Baseline|Total|Total of all reporting groups
11266024|NCT02683707|FG000|Participant Flow|PCI Without Intranvenous (IV) Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for percutaneous coronary intervention [PCI])~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266025|NCT02683707|FG001|Participant Flow|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266026|NCT02683707|OG000|Outcome|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266027|NCT02683707|OG001|Outcome|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266028|NCT02683707|EG000|Reported Event|PCI Without IV Opiate|"IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)~Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266029|NCT02683707|EG001|Reported Event|PCI With IV Opiate|"IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia~Fentanyl: IV peri-procedural analgesia~Lidocaine: Local Anesthetic~Midazolam: IV sedation"
11266030|NCT02683746|BG000|Baseline|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266031|NCT02683746|BG001|Baseline|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266032|NCT02683746|BG002|Baseline|Total|Total of all reporting groups
11266033|NCT02683746|FG000|Participant Flow|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266034|NCT02683746|FG001|Participant Flow|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266035|NCT02683746|OG000|Outcome|Albiglutide Liquid|Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266036|NCT02683746|OG001|Outcome|Albiglutide Lyophilized|Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
11266037|NCT02683746|EG000|Reported Event|Albiglutide Active LAI Plus Placebo Lyophilized DCC PI|Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
11266038|NCT02683746|EG001|Reported Event|Albiglutide Lyophilized DCC PI Plus Placebo LAI|Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
11266039|NCT02683772|BG000|Baseline|Study Total|This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
11266040|NCT02683772|FG000|Participant Flow|iVAPS With AutoEPAP, Then iVAPS With Manual EPAP|This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with AutoEPAP first, and the second night iVAPS with manual EPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.
11266041|NCT02683772|FG001|Participant Flow|iVAPS With Manual EPAP, Then iVAPS With AutoEPAP|This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with manual EPAP first, and the second night iVAPS with AutoEPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.
11266042|NCT02683772|OG000|Outcome|iVAPS With AutoEPAP|This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
11266043|NCT02683772|OG001|Outcome|iVAPS With Manual EPAP|This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
11266044|NCT02683772|OG000|Outcome|iVAPS With AutoEPAP|"Astral device will be set using iVAPS with autoEPAP for the overnight PSG~Astral: Astral ventilator"
11266045|NCT02683772|OG001|Outcome|iVAPS With Manual EPAP|"Astral device will be set using iVAPS with manual EPAP during overnight PSG~Astral: Astral ventilator"
11266046|NCT02683772|OG000|Outcome|iVAPS With AutoEPAP|This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with AutoEPAP first, and the second night iVAPS with manual EPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.
11266047|NCT02683772|OG001|Outcome|iVAPS With Manual EPAP|This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with manual EPAP first, and the second night iVAPS with AutoEPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.
11266048|NCT02683772|EG000|Reported Event|iVAPS With AutoEPAP|This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients.
11266049|NCT02683772|EG001|Reported Event|iVAPS With Manual EPAP|This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients.
11266050|NCT02683785|BG000|Baseline|Placebo|Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266051|NCT02683785|BG001|Baseline|GSK3196165 180mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266052|NCT02683785|BG002|Baseline|Total|Total of all reporting groups
11266053|NCT02683785|FG000|Participant Flow|Placebo|Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266054|NCT02683785|FG001|Participant Flow|GSK3196165 180mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266055|NCT02683785|OG000|Outcome|Placebo|Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266056|NCT02683785|OG001|Outcome|GSK3196165 180mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266057|NCT02683785|OG000|Outcome|GSK3196165 180mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266058|NCT02683785|OG000|Outcome|GSK3196165 180 mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266059|NCT02683785|EG000|Reported Event|Placebo|Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266060|NCT02683785|EG001|Reported Event|GSK3196165 180mg|Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
11266061|NCT02683876|BG000|Baseline|Subjects With Malodor|individuals with self-reported socially debilitating odor episodes
11266062|NCT02683876|BG001|Baseline|Healthy Control|individuals not complaining of uncontrollable or unpredictable malodor episodes
11266063|NCT02683876|BG002|Baseline|Total|Total of all reporting groups
11266064|NCT02683876|FG000|Participant Flow|Subjects With Malodor|individuals with self-reported socially debilitating odor episodes
11266065|NCT02683876|FG001|Participant Flow|Healthy Control|individuals not complaining of uncontrollable or unpredictable malodor episodes
11266066|NCT02683876|OG000|Outcome|Subjects With Malodor|individuals with self-reported socially debilitating odor episodes
11266067|NCT02683876|OG001|Outcome|Healthy Control|individuals not complaining of uncontrollable or unpredictable malodor episodes
11266068|NCT02683876|OG000|Outcome|Subjects With More Severe Disease|More severe form of MEBO based on self-reports and prior tests
11266069|NCT02683876|OG001|Outcome|Subjects With Less Severe Disease|Subjects with less severe symptoms based on self-reports
11266070|NCT02683876|EG000|Reported Event|Subjects With Malodor|individuals with self-reported socially debilitating odor episodes
11266071|NCT02683876|EG001|Reported Event|Healthy Control|individuals not complaining of uncontrollable or unpredictable malodor episodes
11266072|NCT02683928|BG000|Baseline|GBR 830|Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart
11266073|NCT02683928|BG001|Baseline|Placebo|Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart
11266074|NCT02683928|BG002|Baseline|Total|Total of all reporting groups
11266075|NCT02683928|FG000|Participant Flow|GBR 830|Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart
11266076|NCT02683928|FG001|Participant Flow|Placebo|Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart
11266077|NCT02683928|OG000|Outcome|GBR 830|Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart
11266078|NCT02683928|OG001|Outcome|Placebo|Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart
11266079|NCT02683928|EG000|Reported Event|GBR 830|Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart
11266080|NCT02683928|EG001|Reported Event|Placebo|Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart
11266081|NCT02683941|BG000|Baseline|Lanreotide|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
11337542|NCT03587207|BG004|Baseline|MenACWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
11337543|NCT03587207|BG005|Baseline|Total|Total of all reporting groups
11266082|NCT02683941|BG001|Baseline|Placebo|Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
11266083|NCT02683941|BG002|Baseline|Total|Total of all reporting groups
11266084|NCT02683941|FG000|Participant Flow|Lanreotide|Subjects received deep subcutaneous (SC) injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
11266085|NCT02683941|FG001|Participant Flow|Placebo|Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
11266086|NCT02683941|OG000|Outcome|Overall Study: Lanreotide|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
11266087|NCT02683941|OG000|Outcome|Double-Blind Phase: Lanreotide|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase they entered the open-label follow-up phase.
11266088|NCT02683941|OG001|Outcome|Double-Blind Phase: Placebo|Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
11266089|NCT02683941|OG002|Outcome|Open-Label Treatment Phase: All Subjects|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
11266090|NCT02683941|EG000|Reported Event|Double-Blind Phase: Lanreotide|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase they entered the open-label follow-up phase.
11266091|NCT02683941|EG001|Reported Event|Double-Blind Phase: Placebo|Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
11266092|NCT02683941|EG002|Reported Event|Open-Label Treatment Phase|Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
11266093|NCT02683941|EG003|Reported Event|Open-Label Follow-Up Phase|If the subject received lanreotide autogel/depot and progressed during the double-blind phase or open-label treatment phase, the subject entered the follow-up phase of the open-label extension phase and was followed for QoL/survival and all subsequent anticancer treatments received. No intervention was received in the open-label follow-up phase.
11266094|NCT02683954|BG000|Baseline|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266095|NCT02683954|BG001|Baseline|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266096|NCT02683954|BG002|Baseline|Total|Total of all reporting groups
11266097|NCT02683954|FG000|Participant Flow|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266098|NCT02683954|FG001|Participant Flow|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266099|NCT02683954|OG000|Outcome|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266100|NCT02683954|OG001|Outcome|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266101|NCT02683954|EG000|Reported Event|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266102|NCT02683954|EG001|Reported Event|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
11266103|NCT02684097|BG000|Baseline|Tralokinumab|Tralokinumab subcutaneous injection every two weeks for 24 weeks
11266104|NCT02684097|BG001|Baseline|Placebo|Saline subcutaneous injection every two weeks for 24 weeks.
11266105|NCT02684097|BG002|Baseline|Total|Total of all reporting groups
11266106|NCT02684097|FG000|Participant Flow|Tralokinumab|Tralokinumab subcutaneous injection every two weeks for 24 weeks
11266107|NCT02684097|FG001|Participant Flow|Placebo|Saline subcutaneous injection every two weeks for 24 weeks.
11266108|NCT02684097|OG000|Outcome|Tralokinumab|Tralokinumab subcutaneous injection every two weeks for 24 weeks
11266109|NCT02684097|OG001|Outcome|Placebo|Saline subcutaneous injection every two weeks for 24 weeks.
11266110|NCT02684097|EG000|Reported Event|Tralokinumab|Tralokinumab subcutaneous injection every two weeks for 24 weeks
11266111|NCT02684097|EG001|Reported Event|Placebo|Saline subcutaneous injection every two weeks for 24 weeks.
11266112|NCT02684136|BG000|Baseline|All Study Participants|this is a crossover study with 20 mg suvorexant and placebo each administered for 9 nights
11266113|NCT02684136|FG000|Participant Flow|Suvorexant First, Then Placebo|9 nights of 20 mg suvorexant first, then 9 nights of placebo suvorexant: suvorexant 20 mg taken before sleep; placebo taken before sleep
11266114|NCT02684136|FG001|Participant Flow|Placebo First, Then Suvorexant|9 nights placebo first, washout, then 9 nights of 20 mg suvorexant: suvorexant 20 mg taken before sleep; placebo taken before sleep
11266115|NCT02684136|OG000|Outcome|Suvorexant|"9 nights of 20 mg suvorexant~suvorexant: suvorexant 20 mg taken before sleep"
11266116|NCT02684136|OG001|Outcome|Placebo|"9 nights placebo~placebo: placebo taken before sleep"
11266117|NCT02684136|EG000|Reported Event|Suvorexant|"9 nights of 20 mg suvorexant~suvorexant: suvorexant 20 mg taken before sleep"
11266118|NCT02684136|EG001|Reported Event|Placebo|"9 nights placebo~placebo: placebo taken before sleep"
11266119|NCT02684188|BG000|Baseline|Current Treatment|Patients receive that current discharge planning services and supports.
11266120|NCT02684188|BG001|Baseline|Enhanced Transitions Planning|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient."
11266121|NCT02684188|BG002|Baseline|Total|Total of all reporting groups
11266122|NCT02684188|FG000|Participant Flow|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
11266123|NCT02684188|FG001|Participant Flow|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
11266124|NCT02684188|OG000|Outcome|Standard Hospital Discharge Services|Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group
11337544|NCT03587207|FG000|Participant Flow|MenABCWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).
11337545|NCT03587207|FG001|Participant Flow|rMenBOMV+ACWY_S Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).
11337546|NCT03587207|FG002|Participant Flow|rMenBOMV+ACWY_D Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).
11266125|NCT02684188|OG001|Outcome|Enhanced Discharge & Rural Transition Support|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of recovery supports to the patient.~Enhanced Discharge Planning & Rural Transition Support: While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient."
11266126|NCT02684188|OG000|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services;the baseline and return to baseline groups were combined to form a single standard discharge group
11266127|NCT02684188|OG001|Outcome|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
11266128|NCT02684188|OG000|Outcome|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
11266129|NCT02684188|EG000|Reported Event|Standard Hospital Discharge Planning Services|Patients receive standard discharge planning services.
11266130|NCT02684188|EG001|Reported Event|Enhanced Discharge Planning and Rural Transition Supports|"The intervention consists of a package of procedures that enhances supports during the transitions from the hospital to recovery at home, including a structured needs assessment that produces a plan that matches available rural community service providers to a patient's transition needs and the provision of recovery supports to the patient.~Enhanced Transitions Planning: While in the treating hospital, patients from small towns and rural communities are engaged in a process designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs. Once home, a Local Community Transition Coordinator provides support to address needs."
11266131|NCT02684279|BG000|Baseline|Dasotraline|4, 6, 8 mg flexibly dosed
11266132|NCT02684279|FG000|Participant Flow|Dasotraline|4, 6, 8 mg flexibly dosed
11266133|NCT02684279|OG000|Outcome|Dasotraline|4, 6, 8 mg flexibly dosed
11266134|NCT02684279|EG000|Reported Event|Dasotraline|4, 6, 8 mg flexibly dosed
11266135|NCT02684344|BG000|Baseline|Tamsulosin Group|"Subjects will receive:~0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery~education about signs and symptoms of urinary retention~Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention~Education: Education about signs and symptoms of urinary retention"
11266136|NCT02684344|BG001|Baseline|Education Group|"Subjects will receive:~1) education about signs and symptoms of urinary retention~Education: Education about signs and symptoms of urinary retention"
11266137|NCT02684344|BG002|Baseline|Total|Total of all reporting groups
11266138|NCT02684344|FG000|Participant Flow|Tamsulosin Group|"Subjects will receive:~0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery~education about signs and symptoms of urinary retention~Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention~Education: Education about signs and symptoms of urinary retention"
11266139|NCT02684344|FG001|Participant Flow|Education Group|"Subjects will receive:~1) education about signs and symptoms of urinary retention~Education: Education about signs and symptoms of urinary retention"
11266140|NCT02684344|OG000|Outcome|Tamsulosin Group|"Subjects will receive:~0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery~education about signs and symptoms of urinary retention~Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention~Education: Education about signs and symptoms of urinary retention"
11266141|NCT02684344|OG001|Outcome|Education Group|"Subjects will receive:~1) education about signs and symptoms of urinary retention~Education: Education about signs and symptoms of urinary retention"
11266142|NCT02684344|EG000|Reported Event|Tamsulosin Group|"Subjects will receive:~0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery~education about signs and symptoms of urinary retention~Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention~Education: Education about signs and symptoms of urinary retention"
11266143|NCT02684344|EG001|Reported Event|Education Group|"Subjects will receive:~1) education about signs and symptoms of urinary retention~Education: Education about signs and symptoms of urinary retention"
11266144|NCT02684357|BG000|Baseline|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266145|NCT02684357|BG001|Baseline|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266146|NCT02684357|BG002|Baseline|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266147|NCT02684357|BG003|Baseline|Total|Total of all reporting groups
11266148|NCT02684357|FG000|Participant Flow|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266149|NCT02684357|FG001|Participant Flow|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266150|NCT02684357|FG002|Participant Flow|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266151|NCT02684357|FG003|Participant Flow|Placebo/Risankizumab (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266152|NCT02684357|FG004|Participant Flow|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266153|NCT02684357|FG005|Participant Flow|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266154|NCT02684357|OG000|Outcome|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266155|NCT02684357|OG001|Outcome|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266156|NCT02684357|OG000|Outcome|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266157|NCT02684357|OG000|Outcome|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266158|NCT02684357|OG001|Outcome|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266159|NCT02684357|EG000|Reported Event|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266160|NCT02684357|EG001|Reported Event|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266161|NCT02684357|EG002|Reported Event|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266162|NCT02684357|EG003|Reported Event|Placebo/Risankizumab (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266163|NCT02684357|EG004|Reported Event|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266164|NCT02684357|EG005|Reported Event|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266165|NCT02684370|BG000|Baseline|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266166|NCT02684370|BG001|Baseline|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266167|NCT02684370|BG002|Baseline|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266168|NCT02684370|BG003|Baseline|Total|Total of all reporting groups
11266169|NCT02684370|FG000|Participant Flow|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
10970058|NCT00908596|EG001|Reported Event|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11266170|NCT02684370|FG001|Participant Flow|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266171|NCT02684370|FG002|Participant Flow|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266172|NCT02684370|FG003|Participant Flow|Placebo/Risankizumab (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266173|NCT02684370|FG004|Participant Flow|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266174|NCT02684370|FG005|Participant Flow|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266175|NCT02684370|OG000|Outcome|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266176|NCT02684370|OG001|Outcome|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266177|NCT02684370|OG000|Outcome|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) SC at Weeks 0 and 4 (Part A).
11266178|NCT02684370|OG000|Outcome|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266179|NCT02684370|OG000|Outcome|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266180|NCT02684370|OG001|Outcome|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266181|NCT02684370|EG000|Reported Event|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266182|NCT02684370|EG001|Reported Event|Ustekinumab (Part A)|Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266183|NCT02684370|EG002|Reported Event|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11266184|NCT02684370|EG003|Reported Event|Placebo/Risankizumab (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266185|NCT02684370|EG004|Reported Event|Ustekinumab/Ustekinumab (Part B)|Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266186|NCT02684370|EG005|Reported Event|Risankizumab/Risankizumab (Part B)|Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11266187|NCT02684396|BG000|Baseline|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
11266188|NCT02684396|BG001|Baseline|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
11266189|NCT02684396|BG002|Baseline|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
11266190|NCT02684396|BG003|Baseline|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
11266191|NCT02684396|BG004|Baseline|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
11266192|NCT02684396|BG005|Baseline|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
11266193|NCT02684396|BG006|Baseline|Total|Total of all reporting groups
11266194|NCT02684396|FG000|Participant Flow|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
11266195|NCT02684396|FG001|Participant Flow|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
11266196|NCT02684396|FG002|Participant Flow|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
11266197|NCT02684396|FG003|Participant Flow|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
11266198|NCT02684396|FG004|Participant Flow|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
11266199|NCT02684396|FG005|Participant Flow|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
11266200|NCT02684396|OG000|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
11266201|NCT02684396|OG001|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
11266202|NCT02684396|OG002|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
11266203|NCT02684396|OG003|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
11266204|NCT02684396|OG004|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
11266205|NCT02684396|OG005|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
11266206|NCT02684396|EG000|Reported Event|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
11266207|NCT02684396|EG001|Reported Event|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
11266208|NCT02684396|EG002|Reported Event|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
11266209|NCT02684396|EG003|Reported Event|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
11266210|NCT02684396|EG004|Reported Event|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
11266211|NCT02684396|EG005|Reported Event|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
11266212|NCT02684435|BG000|Baseline|Perflutren Lipid Microsphere|"Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval~Perflutren lipid microsphere: Dosing per approved package label"
11266213|NCT02684435|FG000|Participant Flow|Perflutren Lipid Microsphere|"Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval~Perflutren lipid microsphere: Dosing per approved package label"
11266214|NCT02684435|OG000|Outcome|Perflutren Lipid Microsphere|"Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval~Perflutren lipid microsphere: Dosing per approved package label"
11266215|NCT02684435|EG000|Reported Event|Perflutren Lipid Microsphere|"Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval~Perflutren lipid microsphere: Dosing per approved package label"
11337547|NCT03587207|FG003|Participant Flow|rMenBOMV Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).
11337548|NCT03587207|FG004|Participant Flow|MenACWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
11266216|NCT02684591|BG000|Baseline|Aramchol 600 mg Orally Daily|"Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks.~Intervention: Aramchol~Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters"
11266217|NCT02684591|BG001|Baseline|Placebo|"Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks.~Placebo: Placebo"
11266218|NCT02684591|BG002|Baseline|Total|Total of all reporting groups
11266219|NCT02684591|FG000|Participant Flow|Aramchol 600 mg Orally Daily|"Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks.~Intervention: Aramchol~Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters"
11266220|NCT02684591|FG001|Participant Flow|Placebo|"Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks.~Placebo: Placebo"
11266221|NCT02684591|OG000|Outcome|Aramchol 600 mg Orally Daily|"Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks.~Intervention: Aramchol~Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters"
11266222|NCT02684591|OG001|Outcome|Placebo|"Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks.~Placebo: Placebo"
11266223|NCT02684591|EG000|Reported Event|Aramchol 600 mg Orally Daily|"Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks.~Intervention: Aramchol~Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters"
11266224|NCT02684591|EG001|Reported Event|Placebo|"Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks.~Placebo: Placebo"
11266225|NCT02684604|BG000|Baseline|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
11266226|NCT02684604|BG001|Baseline|Fertile Women|44 fertile women
11266227|NCT02684604|BG002|Baseline|Total|Total of all reporting groups
11266228|NCT02684604|FG000|Participant Flow|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
11266229|NCT02684604|FG001|Participant Flow|Fertile Women|44 fertile women
11266230|NCT02684604|OG000|Outcome|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
11266231|NCT02684604|OG001|Outcome|Fertile Women|44 fertile women
11266232|NCT02684604|EG000|Reported Event|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
11266233|NCT02684604|EG001|Reported Event|Fertile Women|44 fertile women
11266234|NCT02684617|BG000|Baseline|rrCLL Cohort|Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266235|NCT02684617|BG001|Baseline|rrMM Cohort|Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266236|NCT02684617|BG002|Baseline|rrDLBCL Cohort|Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266237|NCT02684617|BG003|Baseline|Total|Total of all reporting groups
11266238|NCT02684617|FG000|Participant Flow|rrCLL Cohort|Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266239|NCT02684617|FG001|Participant Flow|rrMM Cohort|Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266240|NCT02684617|FG002|Participant Flow|rrDLBCL Cohort|Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266241|NCT02684617|OG000|Outcome|rrCLL Cohort|Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266242|NCT02684617|OG001|Outcome|rrMM Cohort|Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266243|NCT02684617|OG002|Outcome|rrDLBCL Cohort|Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266244|NCT02684617|EG000|Reported Event|rrCLL Cohort|Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266245|NCT02684617|EG001|Reported Event|rrMM Cohort|Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266246|NCT02684617|EG002|Reported Event|rrDLBCL Cohort|Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
11266247|NCT02684630|BG000|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266248|NCT02684630|BG001|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266249|NCT02684630|BG002|Baseline|Total|Total of all reporting groups
11266250|NCT02684630|FG000|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266251|NCT02684630|FG001|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266252|NCT02684630|OG000|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
11266253|NCT02684630|OG001|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
11266254|NCT02684630|OG000|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266255|NCT02684630|OG001|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
11266256|NCT02684630|EG000|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
11266257|NCT02684630|EG001|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
11266258|NCT02684942|BG000|Baseline|All Participants|All participants who enrolled to this study.
11266259|NCT02684942|FG000|Participant Flow|Meperidine,Fentanyl,Meperidine,Fentanyl|"First and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266260|NCT02684942|FG001|Participant Flow|Fentanyl,Meperidine,Fentanyl,Meperidine|"First and Third Intervention inject inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266261|NCT02684942|FG002|Participant Flow|Meperidine,Meperidine,Fentanyl,Fentanyl|"First and Second Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266262|NCT02684942|FG003|Participant Flow|Fentanyl,Fentanyl,Meperidine,Meperidine|"First and Second Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266263|NCT02684942|FG004|Participant Flow|Meperidine,Fentanyl,Fentanyl,Meperidine|"First and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266264|NCT02684942|FG005|Participant Flow|Fentanyl,Meperidine,Meperidine,Fentanyl|"First and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
11266265|NCT02684942|OG000|Outcome|Meperidine|Separate analysis in meperidine group.
11266266|NCT02684942|OG001|Outcome|Fentanyl|Separate analysis in fentanyl group.
11266267|NCT02684942|OG000|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
11266268|NCT02684942|OG001|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
11266269|NCT02684942|OG000|Outcome|Meperidine|Analyze in meperidine group.
11266270|NCT02684942|OG001|Outcome|Fentanyl|Analyze in fentanyl group.
11266271|NCT02684942|OG000|Outcome|Fentanyl|Analyze in fentanyl group.
11266272|NCT02684942|EG000|Reported Event|Meperidine|Analyze in meperidine group.
11266273|NCT02684942|EG001|Reported Event|Fentanyl|Analyze in fentanyl group.
11266274|NCT02684981|BG000|Baseline|Cohort A|Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
11266275|NCT02684981|BG001|Baseline|Cohort B- Pradaxa®|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
11266276|NCT02684981|BG002|Baseline|Cohort B- VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266277|NCT02684981|BG003|Baseline|Total|Total of all reporting groups
11266278|NCT02684981|FG000|Participant Flow|Cohort A|Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
10970059|NCT00908596|EG002|Reported Event|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11266279|NCT02684981|FG001|Participant Flow|Cohort B- Pradaxa®|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
11266280|NCT02684981|FG002|Participant Flow|Cohort B- VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266281|NCT02684981|OG000|Outcome|Cohort A|Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
11266282|NCT02684981|OG000|Outcome|Cohort B- Pradaxa®|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
11266283|NCT02684981|OG001|Outcome|Cohort B- VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266284|NCT02684981|OG001|Outcome|Cohort B- Pradaxa®|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
11266285|NCT02684981|OG002|Outcome|Cohort B- VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266286|NCT02684981|OG001|Outcome|Cohort B- Pradaxa|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy were included.
11266287|NCT02684981|OG002|Outcome|Cohort B-VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266288|NCT02684981|OG001|Outcome|Cohort B|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy were included.
11266289|NCT02684981|EG000|Reported Event|Cohort A|Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
11266290|NCT02684981|EG001|Reported Event|Cohort B- Pradaxa®|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
11266291|NCT02684981|EG002|Reported Event|Cohort B- VKA|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
11266292|NCT02684981|EG003|Reported Event|Cohort B|Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) or Vitamin K Antagonist (VKA) therapy were included.
11266293|NCT02685007|BG000|Baseline|TachoSil|TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
11266294|NCT02685007|FG000|Participant Flow|TachoSil|TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
11266295|NCT02685007|OG000|Outcome|TachoSil|TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
11266296|NCT02685007|EG000|Reported Event|TachoSil|TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC.
11266297|NCT02685033|BG000|Baseline|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was < 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
11266298|NCT02685033|BG001|Baseline|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11266299|NCT02685033|BG002|Baseline|Total|Total of all reporting groups
11266300|NCT02685033|FG000|Participant Flow|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was < 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
11266301|NCT02685033|FG001|Participant Flow|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11266302|NCT02685033|OG000|Outcome|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was < 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
11266303|NCT02685033|OG001|Outcome|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11266304|NCT02685033|EG000|Reported Event|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was < 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
10970060|NCT00908596|EG003|Reported Event|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
11266305|NCT02685033|EG001|Reported Event|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
11266306|NCT02685072|BG000|Baseline|TNP + Progesterone|"Transdermal Nicotine Patch + Progesterone (200 mgs BID)~Progesterone (200 mgs BID): TNP + Progesterone"
11266307|NCT02685072|BG001|Baseline|TNP + Placebo|"Transdermal Nicotine Patch + Placebo (for Progesterone)~Placebo: TNP + Placebo"
11266308|NCT02685072|BG002|Baseline|Total|Total of all reporting groups
11266309|NCT02685072|FG000|Participant Flow|TNP + Progesterone|"Transdermal Nicotine Patch + Progesterone (200 mgs BID)~Progesterone (200 mgs BID): TNP + Progesterone"
11266310|NCT02685072|FG001|Participant Flow|TNP + Placebo|"Transdermal Nicotine Patch + Placebo (for Progesterone)~Placebo: TNP + Placebo"
11266311|NCT02685072|OG000|Outcome|TNP + Progesterone|"Transdermal Nicotine Patch + Progesterone (200 mgs BID)~Progesterone (200 mgs BID): TNP + Progesterone"
11266312|NCT02685072|OG001|Outcome|TNP + Placebo|"Transdermal Nicotine Patch + Placebo (for Progesterone)~Placebo: TNP + Placebo"
11266313|NCT02685072|OG000|Outcome|TNP + Progesterone|"Transdermal Nicotine Patch + Progesterone (200 mgs BID)~Progesterone (200 mgs BID): Transdermal Nicotine Patch (TNP) + Progesterone"
11266314|NCT02685072|EG000|Reported Event|TNP + Progesterone|"Transdermal Nicotine Patch + Progesterone (200 mgs BID)~Progesterone (200 mgs BID): TNP + Progesterone"
11266315|NCT02685072|EG001|Reported Event|TNP + Placebo|"Transdermal Nicotine Patch + Placebo (for Progesterone)~Placebo: TNP + Placebo"
11266316|NCT02685267|BG000|Baseline|Docetaxel/Prednisone|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout~Docetaxel~Prednisone"
11266317|NCT02685267|BG001|Baseline|Docetaxel/Prednisone + Enzalutamide|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel.~Docetaxel~Enzalutamide~Prednisone"
11266318|NCT02685267|BG002|Baseline|Total|Total of all reporting groups
11266319|NCT02685267|FG000|Participant Flow|Docetaxel/Prednisone|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout~Docetaxel~Prednisone"
11266320|NCT02685267|FG001|Participant Flow|Docetaxel/Prednisone + Enzalutamide|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel.~Docetaxel~Enzalutamide~Prednisone"
11266321|NCT02685267|OG000|Outcome|Docetaxel/Prednisone|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout~Docetaxel~Prednisone"
11266322|NCT02685267|OG001|Outcome|Docetaxel/Prednisone + Enzalutamide|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel.~Docetaxel~Enzalutamide~Prednisone"
11266323|NCT02685267|EG000|Reported Event|Docetaxel/Prednisone|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout~Docetaxel~Prednisone"
11266324|NCT02685267|EG001|Reported Event|Docetaxel/Prednisone + Enzalutamide|"Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel.~Docetaxel~Enzalutamide~Prednisone"
11266325|NCT02685293|BG000|Baseline|All Randomized Subjects|All subjects randomized to receive treatment.
11266326|NCT02685293|FG000|Participant Flow|GFF MDI, Then Placebo MDI|Subjects first received GFF MDI (PT003) 14.4/9.6 micrograms (μg) as 2 inhalations twice daily (BID) for 7 days in treatment period 1. After a washout period, subjects then received Placebo MDI as 2 inhalations BID for 7 days in treatment period 2.
11266327|NCT02685293|FG001|Participant Flow|Placebo MDI, Then GFF MDI|Subjects first received Placebo MDI as 2 inhalations BID for 7 days in treatment period 1. After a washout period, subjects then received GFF MDI 14.4/9.6 μg as 2 inhalations BID for 7 days in treatment period 2.
11266328|NCT02685293|OG000|Outcome|GFF MDI|GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.
11266329|NCT02685293|OG001|Outcome|Placebo MDI|Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.
11266330|NCT02685293|EG000|Reported Event|GFF MDI|GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.
11266331|NCT02685293|EG001|Reported Event|Placebo|Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.
11266332|NCT02685436|BG000|Baseline|Omeprazole and Domperidone|wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
11266333|NCT02685436|FG000|Participant Flow|Omeprazole and Domperidone|wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
11266334|NCT02685436|OG000|Outcome|Treatment Group|a wheezy infant with positive combined MII-pH and/or reflux esophagitis
11266335|NCT02685436|EG000|Reported Event|Omeprazole and Domperidone|"wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).~Omeprazole and domperidone: wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s)"
11266336|NCT02685488|BG000|Baseline|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266337|NCT02685488|BG001|Baseline|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266338|NCT02685488|BG002|Baseline|Total|Total of all reporting groups
11266339|NCT02685488|FG000|Participant Flow|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266340|NCT02685488|FG001|Participant Flow|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266341|NCT02685488|OG000|Outcome|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266342|NCT02685488|OG001|Outcome|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266343|NCT02685488|EG000|Reported Event|Transcranial Ultrasound|"Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266344|NCT02685488|EG001|Reported Event|Transcranial Ultrasound Sham|"Stimulation with the transcranial ultrasound will be on sham mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.~Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz."
11266345|NCT02685566|BG000|Baseline|All 100 Cases/Study Participants|Each case contributed 2 sets of images: FFDM only as well as DBT plus FFDM. Therefore there were 200 reads acquired from the 100 cases/participants.
11266346|NCT02685566|FG000|Participant Flow|FFDM Plus DBT, Then FFDM Only|Readers to read half of the FFDM plus DBT images followed by half of the FFDM only images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.
11266347|NCT02685566|FG001|Participant Flow|FFDM Only, Then FFDM Plus DBT|Readers to read half of the FFDM only images followed by half of the FFDM plus DBT images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.
11266348|NCT02685566|OG000|Outcome|FFDM Plus DBT|"Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.~This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate)."
11266349|NCT02685566|OG001|Outcome|Full-Field Digital Mammography (FFDM)|"Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.~This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate)."
11266350|NCT02685566|OG000|Outcome|FFDM Plus DBT|"Breast Images with FFDM and DBT~FFDM Plus DBT: FujiFilm Aspire Cristalle System"
11266351|NCT02685566|OG001|Outcome|Full-Field Digital Mammography (FFDM)|"Breast Images with FFDM alone~FFDM: FujiFilm Aspire Cristalle System"
11266352|NCT02685566|EG000|Reported Event|FFDM Plus DBT|"Breast Images with FFDM and DBT~FFDM Plus DBT: FujiFilm Aspire Cristalle System"
11266353|NCT02685566|EG001|Reported Event|Full-Field Digital Mammography|"Breast Images with FFDM alone~FFDM: FujiFilm Aspire Cristalle System"
11266354|NCT02685956|BG000|Baseline|Oral Lesions|Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266355|NCT02685956|BG001|Baseline|Anogenital Lesions|Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266356|NCT02685956|BG002|Baseline|Total|Total of all reporting groups
11266357|NCT02685956|FG000|Participant Flow|Oral Lesions|Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266358|NCT02685956|FG001|Participant Flow|Anogenital Lesions|Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266359|NCT02685956|OG000|Outcome|Anogenital Lesions With POSITIVE HSV1 ELVIS Result|Sample collected from an anogenital lesion and tested positive for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
11266360|NCT02685956|OG001|Outcome|Anogenital Lesions With Negative HSV1 ELVIS Result|Sample collected from an anogenital lesion and tested negative for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
11266361|NCT02685956|OG000|Outcome|Anogenital Lesions With POSITIVE HSV2 ELVIS Result|Sample collected from an anogenital lesion and tested positive for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
11266362|NCT02685956|OG001|Outcome|Anogenital Lesions With NEGATIVE HSV2 ELVIS Result|Sample collected from an anogenital lesion and tested negative for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
11266363|NCT02685956|EG000|Reported Event|Oral Lesions|Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266364|NCT02685956|EG001|Reported Event|Anogenital Lesions|Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
11266365|NCT02685995|BG000|Baseline|Palindrome TDC|TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266366|NCT02685995|BG001|Baseline|VectorFlow TDC|TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266367|NCT02685995|BG002|Baseline|Total|Total of all reporting groups
11266368|NCT02685995|FG000|Participant Flow|Palindrome TDC|TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266369|NCT02685995|FG001|Participant Flow|VectorFlow TDC|TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266370|NCT02685995|OG000|Outcome|Palindrome TDC|TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266371|NCT02685995|OG001|Outcome|VectorFlow TDC|TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266372|NCT02685995|EG000|Reported Event|Palindrome TDC|TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266373|NCT02685995|EG001|Reported Event|VectorFlow TDC|TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
11266374|NCT02686034|BG000|Baseline|gammaCore-S|"Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication."
11266375|NCT02686034|BG001|Baseline|gammaCore-S Sham|"Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication."
11266376|NCT02686034|BG002|Baseline|Total|Total of all reporting groups
11266377|NCT02686034|FG000|Participant Flow|gammaCore-S|"Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication."
11266378|NCT02686034|FG001|Participant Flow|gammaCore-S Sham|"Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication."
11266379|NCT02686034|OG000|Outcome|gammaCore-S|"Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication."
11266380|NCT02686034|OG001|Outcome|gammaCore-S Sham|"Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication."
11266381|NCT02686034|EG000|Reported Event|gammaCore-S|"Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication."
11266382|NCT02686034|EG001|Reported Event|gammaCore-S Sham|"Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve~gammaCore-S Sham: At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication."
11266383|NCT02686138|BG000|Baseline|50mg BID|"Tenapanor, 50mg BID (100mg total)~Tenapanor"
11266384|NCT02686138|BG001|Baseline|Placebo|"Placebo~Placebo"
11266385|NCT02686138|BG002|Baseline|Total|Total of all reporting groups
11266386|NCT02686138|FG000|Participant Flow|50mg BID|"Tenapanor, 50mg BID (100mg total)~Tenapanor"
11266387|NCT02686138|FG001|Participant Flow|Placebo|"Placebo~Placebo"
11266388|NCT02686138|OG000|Outcome|50mg BID|"Tenapanor, 50mg BID (100mg total)~Tenapanor"
11266389|NCT02686138|OG001|Outcome|Placebo|"Placebo~Placebo"
11266390|NCT02686138|EG000|Reported Event|50mg BID|"Tenapanor, 50mg BID (100mg total)~Tenapanor"
11266391|NCT02686138|EG001|Reported Event|Placebo|"Placebo~Placebo"
11266392|NCT02686164|BG000|Baseline|Midazolam + Lenvatinib|Participants received midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day -3, Day 1 and Day 14 of Cycle 1 and lenvatinib 24 mg capsules, orally, QD, on each morning, continuously for 28 days of Cycle 1, starting on Day 1 of Cycle 1. Participants continued to fast for 2 hours postdose of midazolam. Duration of each cycle = 28 days.
11266393|NCT02686164|FG000|Participant Flow|Midazolam + Lenvatinib|Participants received midazolam 4 milligram (mg) (2 milliliter [mL]) syrup, orally, once daily (QD), after an overnight fast on Day -3, Day 1 and Day 14 of Cycle 1 and lenvatinib 24 mg capsules, orally, QD, on each morning, continuously for 28 days of Cycle 1, starting on Day 1 of Cycle 1. Participants continued to fast for 2 hours postdose of midazolam. Duration of each cycle equal to (=) 28 days.
11266394|NCT02686164|OG000|Outcome|Cycle 1 Day -3: Midazolam|Participants received midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day-3 of Cycle 1. Participants continued to fast for 2 hours post dose of midazolam.
11266395|NCT02686164|OG001|Outcome|Cycle 1 Day 1: Lenvatinib + Midazolam|Participants received lenvatinib 24 mg capsules, orally, QD, in the morning and midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day 1 of Cycle 1. Participants continued to fast for 2 hours post dose of midazolam.
11266396|NCT02686164|OG002|Outcome|Cycle 1 Day 14: Lenvatinib + Midazolam|Participants received lenvatinib 24 mg capsules, orally, QD, in the morning and midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day 14 of Cycle 1. Participants continued to fast for 2 hours post dose of midazolam.
11266397|NCT02686164|OG000|Outcome|Midazolam + Lenvatinib|Participants received midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day -3, Day 1 and Day 14 of Cycle 1 and lenvatinib 24 mg capsules, orally, QD, on each morning, continuously for 28 days of Cycle 1, starting on Day 1 of Cycle 1. Participants continued to fast for 2 hours postdose of midazolam. Duration of each cycle = 28 days.
10970061|NCT00908791|BG000|Baseline|Single Arm Study|Women with histologically proven invasive non-metastatic breast cancer.
10970062|NCT00908791|FG000|Participant Flow|Conjugated Linoleic Acid|Women with histologically proven invasive non-metastatic breast cancer.
11266398|NCT02686164|EG000|Reported Event|Midazolam + Lenvatinib|Participants received midazolam 4 mg (2 mL) syrup, orally, QD, after an overnight fast on Day -3, Day 1 and Day 14 of Cycle 1 and lenvatinib 24 mg capsules, orally, QD, on each morning, continuously for 28 days of Cycle 1, starting on Day 1 of Cycle 1. Participants continued to fast for 2 hours postdose of midazolam. Duration of each cycle = 28 days.
11266399|NCT02686437|BG000|Baseline|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266400|NCT02686437|BG001|Baseline|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266401|NCT02686437|BG002|Baseline|Total|Total of all reporting groups
11266402|NCT02686437|FG000|Participant Flow|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266403|NCT02686437|FG001|Participant Flow|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266404|NCT02686437|OG000|Outcome|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266405|NCT02686437|OG001|Outcome|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266406|NCT02686437|EG000|Reported Event|Increasing Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:~Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
11266407|NCT02686437|EG001|Reported Event|Control Tension|"The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an I strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension~TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment."
10970063|NCT00908791|OG000|Outcome|Pre CLA|Women with histologically proven invasive non-metastatic breast cancer.
10970064|NCT00908791|OG001|Outcome|Post CLA|Women with histologically proven invasive non-metastatic breast cancer.
11266408|NCT02687035|BG000|Baseline|SAPIEN 3|Intermediate risk patients receiving the SAPIEN S3 valve with Commander or Certitude delivery system.
11266409|NCT02687035|FG000|Participant Flow|SAPIEN 3|Patients at intermediate surgical risk receiving the SAPIEN S3 valve with Commander or Certitude delivery system.
11266410|NCT02687035|OG000|Outcome|SAPIEN 3|Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
11266411|NCT02687035|EG000|Reported Event|SAPIEN 3|Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
11266412|NCT02687126|BG000|Baseline|Demographic Variables|gender, age, weight, height, cross sectional area, body surface area
11266413|NCT02687126|FG000|Participant Flow|Ultrasound Guided Central Venous Catheterization|Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients
11266414|NCT02687126|OG000|Outcome|Number of Attempts|An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
11266415|NCT02687126|OG000|Outcome|Time to Successful Cannulation|Time taken in seconds from skin prick to aspiration of blood from catheter
11266416|NCT02687126|OG000|Outcome|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
11266417|NCT02687126|OG000|Outcome|Correlation|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate
11266418|NCT02687126|EG000|Reported Event|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
11266419|NCT02687139|BG000|Baseline|18F-DCFPyL PET/CT|Men and women of all races and ethnic groups are eligible for this study were encouraged to participate.
11266420|NCT02687139|FG000|Participant Flow|18F-DCFPyL PET/CT|18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
11266421|NCT02687139|OG000|Outcome|18F-DCFPyL PET/CT|18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
11266422|NCT02687139|EG000|Reported Event|18F-DCFPyL PET/CT|18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
11266423|NCT02687191|BG000|Baseline|PF-05230907 5 Microgram Per Kilogram (mcg/kg)|PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.
11266424|NCT02687191|BG001|Baseline|PF-05230907 8 mcg/kg|PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.
11266425|NCT02687191|BG002|Baseline|PF-05230907 12 mcg/kg|PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.
11266426|NCT02687191|BG003|Baseline|PF-05230907 19 mcg/kg|PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.
11266427|NCT02687191|BG004|Baseline|PF-05230907 24 mcg/kg|PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.
11266428|NCT02687191|BG005|Baseline|PF-05230907 30 mcg/kg|PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
11266429|NCT02687191|BG006|Baseline|Total|Total of all reporting groups
11266430|NCT02687191|FG000|Participant Flow|PF-05230907 5 Microgram Per Kilogram (mcg/kg)|PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.
11266431|NCT02687191|FG001|Participant Flow|PF-05230907 8 mcg/kg|PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.
11266432|NCT02687191|FG002|Participant Flow|PF-05230907 12 mcg/kg|PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.
11266433|NCT02687191|FG003|Participant Flow|PF-05230907 19 mcg/kg|PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.
11266434|NCT02687191|FG004|Participant Flow|PF-05230907 24 mcg/kg|PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.
11266435|NCT02687191|FG005|Participant Flow|PF-05230907 30 mcg/kg|PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
11266436|NCT02687191|OG000|Outcome|PF-05230907 5 Microgram Per Kilogram (mcg/kg)|PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.
11266437|NCT02687191|OG001|Outcome|PF-05230907 8 mcg/kg|PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.
11266438|NCT02687191|OG002|Outcome|PF-05230907 12 mcg/kg|PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.
11266439|NCT02687191|OG003|Outcome|PF-05230907 19 mcg/kg|PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.
11266440|NCT02687191|OG004|Outcome|PF-05230907 24 mcg/kg|PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.
11266441|NCT02687191|OG005|Outcome|PF-05230907 30 mcg/kg|PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
11266442|NCT02687191|EG000|Reported Event|PF-05230907 5 Microgram Per Kilogram (mcg/kg)|PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.
11266443|NCT02687191|EG001|Reported Event|PF-05230907 8 mcg/kg|PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.
11266444|NCT02687191|EG002|Reported Event|PF-05230907 12 mcg/kg|PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.
11266445|NCT02687191|EG003|Reported Event|PF-05230907 19 mcg/kg|PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.
11266446|NCT02687191|EG004|Reported Event|PF-05230907 24 mcg/kg|PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.
11266447|NCT02687191|EG005|Reported Event|PF-05230907 30 mcg/kg|PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
11266448|NCT02687217|BG000|Baseline|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
11266449|NCT02687217|BG001|Baseline|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
11266450|NCT02687217|BG002|Baseline|Total|Total of all reporting groups
10970065|NCT00908791|OG000|Outcome|All Study Participants|Women with histologically proven invasive non-metastatic breast cancer.
11266451|NCT02687217|FG000|Participant Flow|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
11266452|NCT02687217|FG001|Participant Flow|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
11266453|NCT02687217|OG000|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
11266454|NCT02687217|OG001|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
11266455|NCT02687217|EG000|Reported Event|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
11266456|NCT02687217|EG001|Reported Event|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
11266457|NCT02687412|BG000|Baseline|Fast-track Surgery|"Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).~Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.~Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet)."
11266458|NCT02687412|BG001|Baseline|Traditional Surgery|"pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.~Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust~pre-operative fasting at least 8h~Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool~intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade~began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust"
11266459|NCT02687412|BG002|Baseline|Total|Total of all reporting groups
11266460|NCT02687412|FG000|Participant Flow|Fast-track Surgery|"Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).~Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.~Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet)."
11266461|NCT02687412|FG001|Participant Flow|Traditional Surgery|"pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.~Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust~pre-operative fasting at least 8h~Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool~intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade~began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust"
11266462|NCT02687412|OG000|Outcome|Fast-track Surgery|"Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).~Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.~Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet)."
11266463|NCT02687412|OG001|Outcome|Traditional Surgery|"pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.~Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust~pre-operative fasting at least 8h~Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool~intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade~began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust"
11286781|NCT02892448|OG000|Outcome|Unilateral Hip Resurfacing|"Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11266464|NCT02687412|EG000|Reported Event|Fast-track Surgery|"Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).~Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.~Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet)."
11266465|NCT02687412|EG001|Reported Event|Traditional Surgery|"pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.~Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust~pre-operative fasting at least 8h~Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool~intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade~began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust"
11266466|NCT02687451|BG000|Baseline|Group A (6 Months - <2 Years) 0.05 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266467|NCT02687451|BG001|Baseline|Group A (6 Months - <2 Years) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266468|NCT02687451|BG002|Baseline|Group A (6 Months - <2 Years) 0.15 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266469|NCT02687451|BG003|Baseline|Group B (61 Days - <6 Months) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266470|NCT02687451|BG004|Baseline|Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
11266471|NCT02687451|BG005|Baseline|Placebo|Sodium Chloride 0.9%; comparator for multiple dose phase.
11266472|NCT02687451|BG006|Baseline|Total|Total of all reporting groups
11266473|NCT02687451|FG000|Participant Flow|Group A (6 Months - <2 Years) 0.05 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266474|NCT02687451|FG001|Participant Flow|Group A (6 Months - <2 Years) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266475|NCT02687451|FG002|Participant Flow|Group A (6 Months - <2 Years) 0.15 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266476|NCT02687451|FG003|Participant Flow|Group B (61 Days - <6 Months) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266477|NCT02687451|FG004|Participant Flow|Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
11266478|NCT02687451|FG005|Participant Flow|Placebo|Sodium Chloride 0.9%; comparator for multiple dose phase.
11266479|NCT02687451|OG000|Outcome|Group A (6 Months - <2 Years) 0.05 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266480|NCT02687451|OG001|Outcome|Group A (6 Months - <2 Years) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266481|NCT02687451|OG002|Outcome|Group A (6 Months - <2 Years) 0.15 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266482|NCT02687451|OG003|Outcome|Group B (61 Days - <6 Months) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266483|NCT02687451|OG004|Outcome|Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
11266484|NCT02687451|OG005|Outcome|Placebo|Sodium Chloride 0.9%; comparator for multiple dose phase.
11266485|NCT02687451|OG000|Outcome|Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
11266486|NCT02687451|OG001|Outcome|Placebo|Sodium Chloride 0.9%; comparator for multiple dose phase.
11266487|NCT02687451|EG000|Reported Event|Group A (6 Months - <2 Years) 0.05 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266488|NCT02687451|EG001|Reported Event|Group A (6 Months - <2 Years) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266489|NCT02687451|EG002|Reported Event|Group A (6 Months - <2 Years) 0.15 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266490|NCT02687451|EG003|Reported Event|Group B (61 Days - <6 Months) 0.10 mg/kg|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase.
11266491|NCT02687451|EG004|Reported Event|Oxymorphone HCl Multiple Dose Phase (6 Months - <2 Years)|Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection.
11266492|NCT02687451|EG005|Reported Event|Placebo|Sodium Chloride 0.9%; comparator for multiple dose phase.
11266493|NCT02687529|BG000|Baseline|Low Risk|"Tested with CST001~CST001"
11266494|NCT02687529|BG001|Baseline|Known Risk|"Tested with CST001~CST001"
11266495|NCT02687529|BG002|Baseline|Total|Total of all reporting groups
11266496|NCT02687529|FG000|Participant Flow|Low Risk|"Tested with CST001~CST001"
11266497|NCT02687529|FG001|Participant Flow|Known Risk|"Tested with CST001~CST001"
10970066|NCT00908791|OG000|Outcome|Mean # of Stained Cells Per Microscope Field Pre CLA|Women with histologically proven invasive non-metastatic breast cancer.
11266498|NCT02687529|OG000|Outcome|Low Risk|"Tested with CST001~CST001"
11266499|NCT02687529|OG001|Outcome|Known Risk|"Tested with CST001~CST001"
11266500|NCT02687529|EG000|Reported Event|Low Risk|"Tested with CST001~CST001"
11266501|NCT02687529|EG001|Reported Event|Known Risk|"Tested with CST001~CST001"
11266502|NCT02687542|BG000|Baseline|Placebo|"The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266503|NCT02687542|BG001|Baseline|PF-06649751 1 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266504|NCT02687542|BG002|Baseline|PF-06649751 3 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266505|NCT02687542|BG003|Baseline|PF-06649751 7 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266506|NCT02687542|BG004|Baseline|PF-06649751 15 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266507|NCT02687542|BG005|Baseline|Total|Total of all reporting groups
11266508|NCT02687542|FG000|Participant Flow|Placebo|"The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266509|NCT02687542|FG001|Participant Flow|PF-06649751 1 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266510|NCT02687542|FG002|Participant Flow|PF-06649751 3 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266511|NCT02687542|FG003|Participant Flow|PF-06649751 7 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266512|NCT02687542|FG004|Participant Flow|PF-06649751 15 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266513|NCT02687542|OG000|Outcome|Placebo|"The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266514|NCT02687542|OG001|Outcome|PF-06649751 1 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266515|NCT02687542|OG002|Outcome|PF-06649751 3 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266516|NCT02687542|OG003|Outcome|PF-06649751 7 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266517|NCT02687542|OG004|Outcome|PF-06649751 15 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266518|NCT02687542|EG000|Reported Event|Placebo|"The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266519|NCT02687542|EG001|Reported Event|PF-06649751 1 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266520|NCT02687542|EG002|Reported Event|PF-06649751 3 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266521|NCT02687542|EG003|Reported Event|PF-06649751 7 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266522|NCT02687542|EG004|Reported Event|PF-06649751 15 mg QD|"The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed.~Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa.~A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety."
11266523|NCT02687711|BG000|Baseline|Brivaracetam (BRV)|Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC).
11266524|NCT02687711|FG000|Participant Flow|Brivaracetam (BRV)|Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC).
11266525|NCT02687711|OG000|Outcome|Brivaracetam (FAS)|Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Full Analysis Set (FAS).
11266526|NCT02687711|EG000|Reported Event|Brivaracetam (SS)|Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). Participants formed the Safety Set (SS).
11266527|NCT02687815|BG000|Baseline|Vitamin D3|"Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily~vitamin D3 4000 IU: The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap."
11266528|NCT02687815|BG001|Baseline|Placebo|"placebo formulations will be in gel cap form and identical to the active drug~Placebo: The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap."
11266529|NCT02687815|BG002|Baseline|Total|Total of all reporting groups
11266530|NCT02687815|FG000|Participant Flow|Vitamin D3|"Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily~vitamin D3 4000 IU: The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap."
11266531|NCT02687815|FG001|Participant Flow|Placebo|"placebo formulations will be in gel cap form and identical to the active drug~Placebo: The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap."
11266532|NCT02687815|OG000|Outcome|Vitamin D3|"Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily~vitamin D3 4000 IU: The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap."
11266533|NCT02687815|OG001|Outcome|Placebo|"placebo formulations will be in gel cap form and identical to the active drug~Placebo: The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap."
11266534|NCT02687815|EG000|Reported Event|Vitamin D3|"Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily~vitamin D3 4000 IU: The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap."
11266535|NCT02687815|EG001|Reported Event|Placebo|"placebo formulations will be in gel cap form and identical to the active drug~Placebo: The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap."
11266536|NCT02687919|BG000|Baseline|Modified Paleo Diet Intervention (MPDI)|"Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)~Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)"
11266537|NCT02687919|BG001|Baseline|Usual Care|Typical physician recommendations for MS.
11266538|NCT02687919|BG002|Baseline|Total|Total of all reporting groups
11266539|NCT02687919|FG000|Participant Flow|Modified Paleo Diet Intervention (MPDI)|"Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)~Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)"
11266540|NCT02687919|FG001|Participant Flow|Usual Care|Typical physician recommendations for MS.
11266541|NCT02687919|OG000|Outcome|Modified Paleo Diet Intervention (MPDI)|"Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)~Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)"
11266542|NCT02687919|OG001|Outcome|Usual Care|Typical physician recommendations for MS.
11266543|NCT02687919|EG000|Reported Event|Modified Paleo Diet Intervention (MPDI)|"Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)~Modified Paleo diet: Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)"
11266544|NCT02687919|EG001|Reported Event|Usual Care|Typical physician recommendations for MS.
11266545|NCT02688153|BG000|Baseline|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve.
11266546|NCT02688153|BG001|Baseline|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve.
11266547|NCT02688153|BG002|Baseline|Total|Total of all reporting groups
11266548|NCT02688153|FG000|Participant Flow|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve.
11266549|NCT02688153|FG001|Participant Flow|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve.
11266550|NCT02688153|OG000|Outcome|EDWARDS INTUITY Valve System, Model 8300A|Subject who received an Edwards INTUITY surgical aortic heart valve.
11266551|NCT02688153|OG001|Outcome|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve.
11266552|NCT02688153|OG000|Outcome|Edwards INTUITY Surgical Aortic Heart Valve|Subject who received an Edwards INTUITY surgical aortic heart valve.
11266553|NCT02688153|EG000|Reported Event|Edwards INTUITY Surgical Aortic Heart Valve|Subject who receive an Edwards INTUITY surgical aortic heart valve.
11266554|NCT02688153|EG001|Reported Event|Control Group - Commercial Surgical Aortic Heart Valve|Subject who received a commercially available surgical aortic heart valve.
11266555|NCT02688192|BG000|Baseline|Arm I (Intervention)|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~Participate in a fitness program which includes:~8 group meetings over 90 minutes weekly~Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266556|NCT02688192|BG001|Baseline|Arm II (Waitlist Control [WLC])|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~After waiting 6 months they will begin the fitness program as described in Arm I~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266557|NCT02688192|BG002|Baseline|Total|Total of all reporting groups
11266558|NCT02688192|FG000|Participant Flow|Arm I (Intervention)|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~Participate in a fitness program which includes:~8 group meetings over 90 minutes weekly~Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266559|NCT02688192|FG001|Participant Flow|Arm II (Waitlist Control [WLC])|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~After waiting 6 months they will begin the fitness program as described in Arm I~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266560|NCT02688192|OG000|Outcome|Arm I (Intervention)|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~Participate in a fitness program which includes:~8 group meetings of 90 minutes weekly~Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266561|NCT02688192|OG001|Outcome|Arm II (Waitlist Control [WLC])|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~After waiting 6 months they will begin the fitness program as described in Arm I~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266562|NCT02688192|OG000|Outcome|ALL: Arm I (Intervention) and Arm II (WLC)|All participants from Arm I and Arm II who started the 12-week intervention.
11266563|NCT02688192|EG000|Reported Event|Arm I (FitSurvivor Intervention)|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~Participate in a fitness program which includes:~8 group meetings of 90 minutes weekly~Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266564|NCT02688192|EG001|Reported Event|Arm II (Waitlist Control [WLC])|"Assessment including~Wear an electronic accelerometer~Quality of life assessment~Physical fitness evaluation~After waiting 6 months they will begin the fitness program as described in Arm I~Exercise Intervention: Participate in fitness program~Internet-Based Intervention: Engage in private social support messaging and Use the mobile app~Monitoring Device: Wear an electronic accelerometer~Quality-of-Life Assessment: Ancillary studies"
11266565|NCT02688218|BG000|Baseline|Aerobic First, Resistance Second|"Subjects will complete three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. This will be followed by 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises.~Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.~Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises."
11266566|NCT02688218|BG001|Baseline|Resistance First, Aerobic Second|"Subjects will complete 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. This will be followed by three 15 minute periods of aerobic exercise, with 10 minute recovery between each period.~Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.~Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises."
11266567|NCT02688218|BG002|Baseline|Total|Total of all reporting groups
11266568|NCT02688218|FG000|Participant Flow|Aerobic First, Resistance Second|"Subjects will complete three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. This will be followed by 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises.~Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.~Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises."
11266569|NCT02688218|FG001|Participant Flow|Resistance First, Aerobic Second|"Subjects will complete 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. This will be followed by three 15 minute periods of aerobic exercise, with 10 minute recovery between each period.~Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.~Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises."
11266570|NCT02688218|OG000|Outcome|Aerobic Exercise|Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.
11266571|NCT02688218|OG001|Outcome|Resistance Exercise|Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises.
11266572|NCT02688218|EG000|Reported Event|Aerobic Exercise|"Subjects will complete three 15 minute periods of aerobic exercise, with 10 minute recovery between each period.~Aerobic Exercise: Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements."
11266573|NCT02688218|EG001|Reported Event|Resistance Exercise|"Subjects will complete 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises.~Resistance Exercise: Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises."
11266574|NCT02688387|BG000|Baseline|Part 1|In Part 1, there were 5 dosing sessions of four formulations of the FDCs (ambrisentan 10 mg + tadalafil 40 mg) (F1, F2, F3, F4) and 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg (R) which were administered concurrently . The participants received a single oral dose of formulation or the reference during each session. All the doses were taken in fasted condition. The treatment period for Part 1 was of 4-weeks, post which there was a follow-up period of 14 days (which included 7-days washout)
11266575|NCT02688387|BG001|Baseline|Part 2|This comprised of 4 dose sessions, of 3 different granulation sizes for a single FDC (ambrisentan 10 mg +tadalafil 40 mg) compared to the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg & tadalafil 40 mg), to evaluate the bioavailability. This part of the study provided data for 3 granulation size forms of a single FDC formulation selected from Part 1. The participants received a single oral dose during each session. All the doses were taken in fasted condition. The treatment period for Part 2 was of 4-weeks, post which a follow-up period of 14 days (which included 7-days washout). Part 2 had FG1, FG2, FG3 which are Ambrisentan and Tadalafil FDCs (10mg/40mg). R is ambrisentan and tadalafil monotherapies taken concurrently (10mg/40mg).
11266576|NCT02688387|BG002|Baseline|Part 3A|This comprised of 4 dose sessions of the FDC against the reference ambrisentan 10 mg + tadalafil 40mg monotherapies in the fed and fasted state, taken to evaluate the bioequivalence. The participants received a single oral dose during each session, taken under fed and fasted conditions. The fed arms of this part of the study received a standard high fat breakfast. The treatment period of Part 3A was of 4-weeks, post which a follow-up period of 14 days (which included 10-days washout). In Part 3A, X1, X2 are ambrisentan and tadalafil FDCs (10mg/40mg),where X1 is under fed state and X2 is under fasted state. R1, R2 are Ambrisentan and Tadalafil monotherapies taken concurrently(10mg/40mg), where R1 is under fed state and R2 is under fasted state.
11266577|NCT02688387|BG003|Baseline|Part 3B|This study part comprised of 4 dose sessions which assessed the bioequivalence of the two FDC dose strengths, (ambrisentan 5 mg + tadalafil 40mg and ambrisentan 5 mg + tadalafil 20mg) against the reference ambrisentan 5 mg + tadalafil 40mg monotherapies and ambrisentan 5 mg + tadalafil 20mg monotherapies in the fasted state. The treatment period of Part 3B was of 4-weeks, post which there was a follow-up period of 14 days (which included 10-days washout). In the Part 3B, Y1, Y2 are ambrisentan and tadalafil FDCs, under fasted state, where Y1 is 5mg/40mg and Y2 is 5mg/20mg and R3, R4 are ambrisentan and tadalafil monotherapies taken concurrently, under fasted state, where R3 is 5mg/40mg and R4 is 5mg/20mg.
11266578|NCT02688387|BG004|Baseline|Total|Total of all reporting groups
11266579|NCT02688387|FG000|Participant Flow|Part 1, F2/ F3/ F1/ F4/ R|The eligible participants in the Sequence (F2/ F3/ F1/ F4/ R) received a single oral dose of fixed dose combination (FDC) for GSK3380154 (ambrisentan 10 milligram [mg] + tadalafil 40 mg). Participants received single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg Sodium laurilsulfate [SLS]) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, which was followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266580|NCT02688387|FG001|Participant Flow|Part 1, R/ F1/ F4/ F2/ F3|The eligible participants in the Sequence (R/ F1/ F4/ F2/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 2, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS during Period 4, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 5.Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11337549|NCT03587207|OG000|Outcome|MenABCWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).
11266581|NCT02688387|FG002|Participant Flow|Part 1, F4/ F3/ R/ F2/ F1|The eligible participants in the Sequence (F4/ F3/ R/ F2/ F1), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 1, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by single oral dose F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266582|NCT02688387|FG003|Participant Flow|Part 1, F2/ F1/ F3/ R/ F4|The eligible participants in the Sequence (F2/ F1/ F3/ R/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 1, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 2, followed by single oral dose F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS) during Period 3, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266583|NCT02688387|FG004|Participant Flow|Part 1, F3/ F2/ F4/ F1/ R|The eligible participants in the Sequence (F3/ F2/ F4/ F1/ R), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 3, followed by single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266584|NCT02688387|FG005|Participant Flow|Part 1, F1/ F2/ R/ F3/ F4|The eligible participants in the Sequence (F1/ F2/ R/ F3/ F4), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 1, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 2, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently, during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266585|NCT02688387|FG006|Participant Flow|Part 1, F3/ F4/ F2/ R/ F1|The eligible participants in the Sequence (F3/ F4/ F2/ R/ F1), , received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 1, followed by single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 4, followed by received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS) during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266586|NCT02688387|FG007|Participant Flow|Part 1, F4/ R/ F3/ F1/ F2|The eligible participants in the Sequence (F4/ R/ F3/ F1/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS)during Period 1, followed by a single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2,followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 3, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 4, followed by a single oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266587|NCT02688387|FG008|Participant Flow|Part 1, R/ F4/ F1/ F3/ F2|The eligible participants in the Sequence (R/ F4/ F1/ F3/ F2), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 1, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 2, followed single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS), during Period 3, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 4, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266588|NCT02688387|FG009|Participant Flow|Part 1, F1/ R/ F2/ F4/ F3|The eligible participants in the Sequence (F1/ R/ F2/ F4/ F3), received a single oral dose of FDC for GSK3380154 (ambrisentan 10 mg + tadalafil 40 mg). Participants received single oral dose of F1(FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS),during Period 1, followed by single oral dose of R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil, taken concurrently during Period 2, followed by a s ingle oral dose of F2 (FDC 2-GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, during Period 3, followed by a single oral dose of F4 (FDC4- GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS) during Period 4, followed by a single oral dose of F3 (FDC 3- GSK3380154, TAB-A, Tablet Weight 560mg/2mg SLS), during Period 5. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266589|NCT02688387|FG010|Participant Flow|Part 2, R/ FG1/ FG3/ FG2|The eligible participants in the Sequence (R/ FG1/ FG3/ FG2) were administered the 2 monotherapies ambrisentan and tadalafil concurrently, during Period 1, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 2, this was followed by the single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266590|NCT02688387|FG011|Participant Flow|Part 2, FG1/FG2/R/ FG3|The eligible participants in the Sequence (FG1/FG2/R/ FG3) were administered single oral dose of FG1 given as FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 1, this was followed by the single oral dose of FG2 given as FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 2, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 3, this was followed by single oral dose of FG3 given as FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266591|NCT02688387|FG012|Participant Flow|Part 2, FG2/ FG3/ FG1/ R|The eligible participants in the Sequence (FG2/ FG3/ FG1/ R), were administered single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 1, this was followed by single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 2, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 3, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266592|NCT02688387|FG013|Participant Flow|Part 2, FG3/ R/ FG2/ FG1|The eligible participants in the Sequence (FG3/ R/ FG2/ FG1),were administered with single oral dose of the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1, administered during Period 1, this was followed by the 2 monotherapies R, a Reference- single monotherapies of 10 mg ambrisentan and 20 mg of tadalafil concurrently, from the formulation selected from Part 1, given during Period 2, this was followed by single oral dose of FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1 during Period 3, this was followed by single oral dose of FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg), with formulation selected from Part 1, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 7-Days.
11266593|NCT02688387|FG014|Participant Flow|Part 3A, X2/ R2/ R1/ X1|Eligible participants received single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 1, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 2, this was followed by a single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 3, followed by a single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
11266594|NCT02688387|FG015|Participant Flow|Part 3A, ,X1/ R1/ R2/ X2|Eligible participants received single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of a high fat diet, during Period 1, followed by single oral dose of R1 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 2, followed by single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 3, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose taken either under fed or fasted condition and separated by washout period of 10-Days.
11266595|NCT02688387|FG016|Participant Flow|Part 3A, R1/ X2/ X1/ R2|Eligible participants were administered single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising of high fat diet during Period 1, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state during Period 2, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, comprising high fat diet, during Period 3, followed by single oral dose of R2 where participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
11286782|NCT02892448|OG001|Outcome|Bilateral Hip Resurfacing|"Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11266596|NCT02688387|FG017|Participant Flow|Part 3A, ,R2/ X1/ X2/ R1|Eligible participants were administered single oral dose of R2 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state during Period 1, followed by single oral dose of X1 where participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state, which comprised of high fat diet, during Period 2, followed by single oral dose of X2 as FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (granular formulation selected from Part 2), under fasted state during Period 3, followed by single oral dose of R1 where participants had received 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state, comprising high fat diet during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fed or fasted condition and separated by washout period of 10-Days.
11266597|NCT02688387|FG018|Participant Flow|Part 3B, Y1/ R3/ R4/ Y2|The eligible participants in the Sequence (Y1/ R3/ R4/ Y2), where participants for Y1 dose were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R3 the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg during Period 2, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 3, this was followed by Y2 dose where the participants received a single oral dose of received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
11266598|NCT02688387|FG019|Participant Flow|Part 3B, R3/ Y2/ Y1/ R4|The eligible participants in the Sequence (R3/ Y2/ Y1/ R4), where the participants for R3 dose were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose, during Period 1, this was followed by the Y2 dose, where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 2, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
11266599|NCT02688387|FG020|Participant Flow|Part 3B, Y2/ R4/ R3/ Y1|The eligible participants in the Sequence (Y2/ R4/ R3/ Y1), received single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 1, this was followed by a single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 2, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 3, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
11266600|NCT02688387|FG021|Participant Flow|Part 3B, R4/ Y1/ Y2/ R3|The eligible participants in the Sequence (R4/ Y1/ Y2/ R3), received single oral dose of R4, where the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state, during Period 1, this was followed by the Y1 dose where the participants were administered a single oral dose of FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose during Period 2, this was followed by single oral dose of Y2 where the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose during Period 3, this was followed by a single oral dose of R3 dose where participants were administered a single oral dose of the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state, during Period 4. Overall treatment period was of 4-weeks. Each dose was taken under fasted condition and separated by a washout period of 10-Days.
11266601|NCT02688387|OG000|Outcome|Part 1,Treatment F1|In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2.
11266602|NCT02688387|OG001|Outcome|Part 1,Treatment F2|In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3.
11266603|NCT02688387|OG002|Outcome|Part 1,Treatment F3|In the F3 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TABA, Tablet Weight 560mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F4.
11266604|NCT02688387|OG003|Outcome|Part 1,Treatment F4|In the F4 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
11266605|NCT02688387|OG004|Outcome|Part 1, Treatment R|In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
11266606|NCT02688387|OG000|Outcome|Part 2, Treatment R|Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
11266607|NCT02688387|OG001|Outcome|Part 2, Treatment FG1|Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2.
11266608|NCT02688387|OG002|Outcome|Part 2, Treatment FG2|Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3.
11266609|NCT02688387|OG003|Outcome|Part 2, Treatment FG3|Participants were administered the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG3 was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
11266610|NCT02688387|OG000|Outcome|Part 3A,Treatment X1|In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2.
11266611|NCT02688387|OG001|Outcome|Part 3A,Treatment X2|In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1.
11266612|NCT02688387|OG002|Outcome|Part 3A,Treatment R1|In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
11266613|NCT02688387|OG003|Outcome|Part 3A,Treatment R2|In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
11266614|NCT02688387|OG000|Outcome|Part 3B,Treatment Y1|In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2
11266615|NCT02688387|OG001|Outcome|Part 3B,Treatment R3|In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4.
11266616|NCT02688387|OG000|Outcome|Part 3B,Treatment Y2|In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
11266617|NCT02688387|OG001|Outcome|Part 3B,Treatment R4|In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
11266618|NCT02688387|OG002|Outcome|Part 3A,Treatment R1|In the R1 arm, of Part 3A, , the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
11266619|NCT02688387|OG001|Outcome|Part 3B,Treatment Y2|In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
11266620|NCT02688387|OG002|Outcome|Part 3B,Treatment R3|In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4.
11266621|NCT02688387|OG003|Outcome|Part 3B,Treatment R4|In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
11266622|NCT02688387|OG000|Outcome|Part 1,Treatment F1|In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg Sodium laurilsulfate (SLS), with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2.
11266623|NCT02688387|OG001|Outcome|Part 1,Treatment F2|In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3.
11266624|NCT02688387|OG002|Outcome|Part 1,Treatment F3|In the F3 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): GSK3380154, TABA, Tablet Weight 560mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F4.
10970067|NCT00908791|OG000|Outcome|Correlation of CLA Isomers Matched to Spot 14 Expression|Number of participants demonstrating a change in concentrations of CLA isomers in correlation to Spot 14 expression.
10970068|NCT00908791|OG000|Outcome|Correlation of CLA Isomers Matched to Ki-67 Expression|Number of participants demonstrating a change in concentrations of CLA isomers in correlation to Ki-67 expression.
11266625|NCT02688387|OG003|Outcome|Part 1,Treatment F4|In the F4 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
11266626|NCT02688387|OG000|Outcome|Part 2, Treatment R|Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
11266627|NCT02688387|OG001|Outcome|Part 2, Treatment FG1|Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 milligram (mg) + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2.
11266628|NCT02688387|EG000|Reported Event|Part 1,Treatment F1|In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2.
11266629|NCT02688387|EG001|Reported Event|Part 1,Treatment F2|In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3.
11266630|NCT02688387|EG002|Reported Event|Part 1,Treatment F3|In the F3 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TABA, Tablet Weight 560mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F4.
11266631|NCT02688387|EG003|Reported Event|Part 1,Treatment F4|In the F4 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
11266632|NCT02688387|EG004|Reported Event|Part 1, Treatment R|In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
11266633|NCT02688387|EG005|Reported Event|Part 2, Treatment R|Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days.
10970069|NCT00908791|OG000|Outcome|"# of Grade 1 AEs Deemed Possibly Related to CLA"|Women with histologically proven invasive non-metastatic breast cancer.
11266634|NCT02688387|EG006|Reported Event|Part 2, Treatment FG1|Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2.
11266635|NCT02688387|EG007|Reported Event|Part 2, Treatment FG2|Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3.
11266636|NCT02688387|EG008|Reported Event|Part 2, Treatment FG3|Participants were administered the FDC-G3 granulation size 3 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG3 was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R.
11266637|NCT02688387|EG009|Reported Event|Part 3A,Treatment X1|In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, particpants recived a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2.
11266638|NCT02688387|EG010|Reported Event|Part 3A,Treatment X2|In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1.
11266639|NCT02688387|EG011|Reported Event|Part 3A,Treatment R1|In the R1 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fed state. Fed state comprised of high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose R2.
11266640|NCT02688387|EG012|Reported Event|Part 3A,Treatment R2|In the R2 arm, of Part 3A, the participants had received the 2 monotherapies, for ambrisentan 10 mg and tadalafil 40 mg, as single oral dose, under fasted state. This was followed by a wash-out period of 10-days.
11266641|NCT02688387|EG013|Reported Event|Part 3B,Treatment Y1|In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2
11266642|NCT02688387|EG014|Reported Event|Part 3B,Treatment Y2|In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3.
11266643|NCT02688387|EG015|Reported Event|Part 3B,Treatment R3|In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4.
11266644|NCT02688387|EG016|Reported Event|Part 3B,Treatment R4|In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days.
11266645|NCT02688556|BG000|Baseline|OTX-101 0.09%|0.09% cyclosporine nanomicellar ophthalmic solution
11266646|NCT02688556|BG001|Baseline|Vehicle|vehicle of OTX-101
11266647|NCT02688556|BG002|Baseline|Total|Total of all reporting groups
11266648|NCT02688556|FG000|Participant Flow|OTX-101 0.09%|0.09% cyclosporine nanomicellar ophthalmic solution
11266649|NCT02688556|FG001|Participant Flow|Vehicle|vehicle of OTX-101
11266650|NCT02688556|OG000|Outcome|OTX-101 0.09%|0.09% cyclosporine nanomicellar ophthalmic solution
11266651|NCT02688556|OG001|Outcome|Vehicle|vehicle of OTX-101
11266652|NCT02688556|EG000|Reported Event|OTX-101 0.09%|"0.09% cyclosporine nanomicellar ophthalmic solution.~A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09%"
11266653|NCT02688556|EG001|Reported Event|Vehicle|"vehicle of OTX-101~A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09%"
11266654|NCT02688621|BG000|Baseline|Internet Only|"Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.~Internet Only: 18 month behavioral weight loss intervention delivered online"
11266655|NCT02688621|BG001|Baseline|Internet + Incentives|"Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.~Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing"
11266656|NCT02688621|BG002|Baseline|Total|Total of all reporting groups
11266657|NCT02688621|FG000|Participant Flow|Internet Only|"Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.~Internet Only: 18 month behavioral weight loss intervention delivered online"
11266658|NCT02688621|FG001|Participant Flow|Internet + Incentives|"Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.~Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing"
11266659|NCT02688621|OG000|Outcome|Internet Only|"Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.~Internet Only: 18 month behavioral weight loss intervention delivered online"
11266660|NCT02688621|OG001|Outcome|Internet + Incentives|"Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.~Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing"
11266661|NCT02688621|OG000|Outcome|Internet Only|Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks.
11266662|NCT02688621|OG001|Outcome|Internet + Incentives|"Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.~Internet + Incentives: 6 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing"
11266663|NCT02688621|OG000|Outcome|Internet Only|Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone app. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks.
11266664|NCT02688621|EG000|Reported Event|Internet Only|"Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.~Internet Only: 6 month behavioral weight loss intervention delivered online"
11266665|NCT02688621|EG001|Reported Event|Internet + Incentives|"Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.~Internet + Incentives: 6 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing"
11266666|NCT02688764|BG000|Baseline|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron~PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time."
11266667|NCT02688764|BG001|Baseline|Calcium Acetate (Phoslyra®)|"Formulation:~Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
11266668|NCT02688764|BG002|Baseline|Total|Total of all reporting groups
11266669|NCT02688764|FG000|Participant Flow|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron~PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time."
11266670|NCT02688764|FG001|Participant Flow|Calcium Acetate (Phoslyra®)|"Formulation:~Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
11266671|NCT02688764|OG000|Outcome|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
10970070|NCT00908791|OG001|Outcome|"# of Grade 2 AEs Deemed Possibly Related to CLA"|Women with histologically proven invasive non-metastatic breast cancer.
11266672|NCT02688764|OG000|Outcome|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron~PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time."
11266673|NCT02688764|OG001|Outcome|Calcium Acetate (Phoslyra®)|"Formulation:~Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
11266674|NCT02688764|OG000|Outcome|Calcium Acetate (Phoslyra®)|"Formulation:~Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
11266675|NCT02688764|OG000|Outcome|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time."
11266676|NCT02688764|EG000|Reported Event|PA21 (Velphoro®)|"Formulations:~PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time."
11266677|NCT02688764|EG001|Reported Event|Calcium Acetate (Phoslyra®)|"Formulation:~Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.~Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.~Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time."
11266678|NCT02688829|BG000|Baseline|Treatment Group|"Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.~Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system"
11266679|NCT02688829|FG000|Participant Flow|Treatment Group|"Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.~Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system"
11266680|NCT02688829|OG000|Outcome|Treatment Group|"Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.~Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system"
11266681|NCT02688829|EG000|Reported Event|Treatment Group|"Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.~Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system"
11266682|NCT02688842|BG000|Baseline|Treatment Group|"Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems~Rapamycin target-eluting coronary stent systems (38mm)"
11266683|NCT02688842|FG000|Participant Flow|Treatment Group|"Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems~Rapamycin target-eluting coronary stent systems (38mm)"
11266684|NCT02688842|OG000|Outcome|Treatment Group|"Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems~Rapamycin target-eluting coronary stent systems (38mm)"
11266685|NCT02688842|EG000|Reported Event|Treatment Group|"Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems~Rapamycin target-eluting coronary stent systems (38mm)"
11266686|NCT02688868|BG000|Baseline|New Specifications (Diameter 2.25mm)of Firehawk Stent|"Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease~FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems"
11266687|NCT02688868|FG000|Participant Flow|New Specifications (Diameter 2.25mm)of Firehawk Stent|"Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease~FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems"
11266688|NCT02688868|OG000|Outcome|New Specifications (Diameter 2.25mm)of Firehawk Stent|"Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease~FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems"
11266689|NCT02688868|EG000|Reported Event|New Specifications (Diameter 2.25mm)of Firehawk Stent|"Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease~FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems"
11266690|NCT02689063|BG000|Baseline|Maxigesic IV|"intravenous acetaminophen1000 mg + intravenous ibuprofen 300 mg/100 ml solution for infusion, 100 mL, every 6 hours for 48 hours~Maxigesic IV: IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266691|NCT02689063|BG001|Baseline|IV Acetaminophen|"IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL. every 6 hours for 48 hours~IV Acetaminophen: IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266692|NCT02689063|BG002|Baseline|IV Ibuprofen|"IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL every 6 hours for 48 hours~IV Ibuprofen: IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266693|NCT02689063|BG003|Baseline|Placebo IV|"Placebo IV- 100 mL saline for infusion, 100mL every 6 hours for 48 hours~Placebo IV: Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours"
11266694|NCT02689063|BG004|Baseline|Total|Total of all reporting groups
11266695|NCT02689063|FG000|Participant Flow|Maxigesic IV|"intravenous acetaminophen1000 mg + intravenous ibuprofen 300 mg/100 ml solution for infusion, 100 mL, every 6 hours for 48 hours~Maxigesic IV: IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266696|NCT02689063|FG001|Participant Flow|IV Acetaminophen|"IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL. every 6 hours for 48 hours~IV Acetaminophen: IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266697|NCT02689063|FG002|Participant Flow|IV Ibuprofen|"IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL every 6 hours for 48 hours~IV Ibuprofen: IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266698|NCT02689063|FG003|Participant Flow|Placebo IV|"Placebo IV- 100 mL saline for infusion, 100mL every 6 hours for 48 hours~Placebo IV: Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours"
11266699|NCT02689063|OG000|Outcome|Maxigesic IV|"intravenous acetaminophen1000 mg + intravenous ibuprofen 300 mg/100 ml solution for infusion, 100 mL, every 6 hours for 48 hours~Maxigesic IV: IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266700|NCT02689063|OG001|Outcome|IV Acetaminophen|"IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL. every 6 hours for 48 hours~IV Acetaminophen: IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266701|NCT02689063|OG002|Outcome|IV Ibuprofen|"IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL every 6 hours for 48 hours~IV Ibuprofen: IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266702|NCT02689063|OG003|Outcome|Placebo IV|"Placebo IV- 100 mL saline for infusion, 100mL every 6 hours for 48 hours~Placebo IV: Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours"
11266703|NCT02689063|EG000|Reported Event|Maxigesic IV|"intravenous acetaminophen1000 mg + intravenous ibuprofen 300 mg/100 ml solution for infusion, 100 mL, every 6 hours for 48 hours~Maxigesic IV: IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266704|NCT02689063|EG001|Reported Event|IV Acetaminophen|"IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL. every 6 hours for 48 hours~IV Acetaminophen: IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266705|NCT02689063|EG002|Reported Event|IV Ibuprofen|"IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL every 6 hours for 48 hours~IV Ibuprofen: IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours"
11266706|NCT02689063|EG003|Reported Event|Placebo IV|"Placebo IV- 100 mL saline for infusion, 100mL every 6 hours for 48 hours~Placebo IV: Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours"
11266707|NCT02689076|BG000|Baseline|HIE Notification Plus Care Coordination|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange~Care transitions intervention: Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge"
11266708|NCT02689076|BG001|Baseline|HIE Notification Alone|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange"
11266709|NCT02689076|BG002|Baseline|Usual Care (No HIE Notification and No Care Coordination)|Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]
11266710|NCT02689076|BG003|Baseline|Total|Total of all reporting groups
11266711|NCT02689076|FG000|Participant Flow|HIE Notification Plus Care Coordination|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange~Care transitions intervention: Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge"
11266712|NCT02689076|FG001|Participant Flow|HIE Notification Alone|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange"
11266713|NCT02689076|FG002|Participant Flow|Usual Care (No HIE Notification and No Care Coordination)|Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]
11266714|NCT02689076|OG000|Outcome|HIE Notification Plus Care Coordination|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange~Care transitions intervention: Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge"
11266715|NCT02689076|OG001|Outcome|HIE Notification Alone|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange"
11266716|NCT02689076|OG002|Outcome|Usual Care (No HIE Notification and No Care Coordination)|Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]
11266717|NCT02689076|EG000|Reported Event|HIE Notification Plus Care Coordination|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange~Care transitions intervention: Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge"
11266718|NCT02689076|EG001|Reported Event|HIE Notification Alone|"VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care~HIE Notification: VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange"
11266719|NCT02689076|EG002|Reported Event|Usual Care (No HIE Notification and No Care Coordination)|Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]
11286783|NCT02892448|OG002|Outcome|Non-Metal on Metal Total Hip|"Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286784|NCT02892448|EG000|Reported Event|Unilateral Hip Resurfacing|"Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286785|NCT02892448|EG001|Reported Event|Bilateral Hip Resurfacing|"Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286786|NCT02892448|EG002|Reported Event|Non-Metal on Metal Total Hip|"Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).~Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI."
11286787|NCT02892513|BG000|Baseline|Active|"Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.~Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current."
11286788|NCT02892513|BG001|Baseline|Inactive|"Participants will have inactive device worn for 5 days during and after elective surgery.~Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given."
11286789|NCT02892513|BG002|Baseline|Total|Total of all reporting groups
11337550|NCT03587207|OG001|Outcome|rMenBOMV+ACWY_S Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).
11337551|NCT03587207|OG002|Outcome|rMenBOMV+ACWY_D Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).
10970071|NCT00908791|OG002|Outcome|"# of Grade 3 AEs Deemed Possibly Related to CLA"|Women with histologically proven invasive non-metastatic breast cancer.
11266720|NCT02689154|BG000|Baseline|W8Loss2Go App|"Subjects will complete all stages of W8Loss2Go mHealth intervention.~W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology."
11266721|NCT02689154|FG000|Participant Flow|W8Loss2Go App|"Subjects will complete all stages of W8Loss2Go mHealth intervention.~W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology."
11266722|NCT02689154|OG000|Outcome|W8Loss2Go App|"Subjects will complete all stages of W8Loss2Go mHealth intervention.~W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology."
11266723|NCT02689154|EG000|Reported Event|W8Loss2Go App|"Subjects will complete all stages of W8Loss2Go mHealth intervention.~W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology."
11266724|NCT02689206|BG000|Baseline|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
11266725|NCT02689206|BG001|Baseline|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
11266726|NCT02689206|BG002|Baseline|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
11266727|NCT02689206|BG003|Baseline|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
11266728|NCT02689206|BG004|Baseline|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
11266729|NCT02689206|BG005|Baseline|Total|Total of all reporting groups
11266730|NCT02689206|FG000|Participant Flow|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
11266731|NCT02689206|FG001|Participant Flow|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
11266732|NCT02689206|FG002|Participant Flow|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
11266733|NCT02689206|FG003|Participant Flow|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
11266734|NCT02689206|FG004|Participant Flow|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
11266735|NCT02689206|OG000|Outcome|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
11266736|NCT02689206|OG001|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
11266737|NCT02689206|OG002|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
11266738|NCT02689206|OG003|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
11266739|NCT02689206|OG004|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
11266740|NCT02689206|OG000|Outcome|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
11266741|NCT02689206|OG001|Outcome|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
11266742|NCT02689206|OG002|Outcome|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
11266743|NCT02689206|OG003|Outcome|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
11266744|NCT02689206|EG000|Reported Event|Placebo|Randomized participants received placebo tablet via oral route three times weekly for 29 days.
11266745|NCT02689206|EG001|Reported Event|Dapro 10 mg|Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.
11266746|NCT02689206|EG002|Reported Event|Dapro 15 mg|Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.
11266747|NCT02689206|EG003|Reported Event|Dapro 25 mg|Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.
11266748|NCT02689206|EG004|Reported Event|Dapro 30 mg|Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
11266749|NCT02689219|BG000|Baseline|CD30 Negative/Unknown|Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
11266750|NCT02689219|BG001|Baseline|CD30 Positive|Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
11266751|NCT02689219|BG002|Baseline|Total|Total of all reporting groups
11266752|NCT02689219|FG000|Participant Flow|CD30 Negative/Unknown|Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
11266753|NCT02689219|FG001|Participant Flow|CD30 Positive|Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
11266754|NCT02689219|OG000|Outcome|CD30 Negative/Unknown|Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
11266755|NCT02689219|OG001|Outcome|CD30 Positive|Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
11266756|NCT02689219|EG000|Reported Event|CD30 Negative/Unknown|Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
11266757|NCT02689219|EG001|Reported Event|CD30 Positive|Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
11266758|NCT02689492|BG000|Baseline|Total COPD Patients|Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
11266759|NCT02689492|FG000|Participant Flow|Total COPD Patients|Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
11266760|NCT02689492|OG000|Outcome|Enrollment Visit|Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
11266761|NCT02689492|OG001|Outcome|6-month Follow-up|Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
11266762|NCT02689492|OG002|Outcome|12-month Follow-up|Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
11266763|NCT02689492|OG000|Outcome|Total COPD Patients|Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
11266764|NCT02689492|EG000|Reported Event|Total COPD Patients|Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
11266765|NCT02689804|BG000|Baseline|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
11266766|NCT02689804|BG001|Baseline|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
11266767|NCT02689804|BG002|Baseline|Total|Total of all reporting groups
11266768|NCT02689804|FG000|Participant Flow|Normal-BMI|Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
11266769|NCT02689804|FG001|Participant Flow|Obese-MRI|Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
11266770|NCT02689804|OG000|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
11266771|NCT02689804|OG001|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
11266772|NCT02689804|OG001|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
11266773|NCT02689804|EG000|Reported Event|Normal-BMI on LNG|Women with normal BMI will receive LNG-EC
11266774|NCT02689804|EG001|Reported Event|Normal-BMI on UPA|Women with obese BMI will receive UPA-EC
11266775|NCT02689804|EG002|Reported Event|Obese-BMI on LNG|Women with obese BMI will receive LNG-EC
11266776|NCT02689804|EG003|Reported Event|Obese-BMI on UPA|Women with obese BMI will receive UPA-EC
11337552|NCT03587207|OG003|Outcome|rMenBOMV Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).
11266777|NCT02689973|BG000|Baseline|Self-efficacy|"The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, prompting self-talk. Applications of all BCT included references to self-efficacy beliefs. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning."
11266778|NCT02689973|BG001|Baseline|Planning|"The following BCT were included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.~The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Planning: The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska et al. (2007)"
11266779|NCT02689973|BG002|Baseline|Combined Planning+Self-efficacy|"This condition included all BCT applied in the planning and self-efficacy arms. The intervention was integrated into health promotion-nutrition education program. The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007).~Group and individual components were included. Setting: secondary and high schools."
11266780|NCT02689973|BG003|Baseline|Education|"The education group received extended physical activity education program. The physical activity education was integrated into health promotion-nutrition education program.The education program was applied twice (the baseline and 2-month follow-up).~Education: Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements.~The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning.~Group and individual components were included. Setting: secondary and high schools."
11266781|NCT02689973|BG004|Baseline|Total|Total of all reporting groups
11266782|NCT02689973|FG000|Participant Flow|Self-efficacy|"The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, prompting self-talk. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning."
11266783|NCT02689973|FG001|Participant Flow|Planning|"The following BCT were included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.~The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Planning: The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska et al. (2007)"
11266784|NCT02689973|FG002|Participant Flow|Combined Planning+Self-efficacy|"This condition included all BCT applied in the planning and self-efficacy arms. The intervention was integrated into health promotion-nutrition education program. The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007).~Group and individual components were included. Setting: secondary and high schools."
11286790|NCT02892513|FG000|Participant Flow|Active|"Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.~Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current."
10970072|NCT00908791|OG003|Outcome|"# of Grade 4 AEs Deemed Possibly Related to CLA"|Women with histologically proven invasive non-metastatic breast cancer.
11266785|NCT02689973|FG003|Participant Flow|Education|"The education group received extended physical activity education program. The physical activity education was integrated into health promotion-nutrition education program.The education program was applied twice (the baseline and 2-month follow-up).~Education: Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements.~The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning.~Group and individual components were included. Setting: secondary and high schools."
11266786|NCT02689973|OG000|Outcome|Self-efficacy|"The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, prompting self-talk. Applications of all BCT included references to self-efficacy beliefs. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based"
11266787|NCT02689973|OG001|Outcome|Planning|"The following BCT were included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.~The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Planning: The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska et al. (2007)"
11266788|NCT02689973|OG002|Outcome|Combined Planning+Self-efficacy|"This condition included all BCT applied in the planning and self-efficacy arms. The intervention was integrated into health promotion-nutrition education program. The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007).~Group and individual components were included. Setting: secondary and high schools."
11266789|NCT02689973|OG003|Outcome|Education|"The education group received extended physical activity education program. The physical activity education was integrated into health promotion-nutrition education program.The education program was applied twice (the baseline and 2-month follow-up).~Education: Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements.~The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning.~Group and individual components were included. Setting: secondary and high schools."
11266790|NCT02689973|OG000|Outcome|Self-efficacy|"The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, prompting self-talk. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning."
11266791|NCT02689973|EG000|Reported Event|Self-efficacy|"The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, prompting self-talk. Applications of all BCT included references to self-efficacy beliefs. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based"
11266792|NCT02689973|EG001|Reported Event|Planning|"The following BCT were included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.~The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).~Planning: The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska et al. (2007)"
11266793|NCT02689973|EG002|Reported Event|Combined Planning+Self-efficacy|"This condition included all BCT applied in the planning and self-efficacy arms. The intervention was integrated into health promotion-nutrition education program. The intervention was applied twice (the baseline and 2-month follow-up).~Self-Efficacy: The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007).~Group and individual components were included. Setting: secondary and high schools."
11266794|NCT02689973|EG003|Reported Event|Education|"The education group received extended physical activity education program. The physical activity education was integrated into health promotion-nutrition education program.The education program was applied twice (the baseline and 2-month follow-up).~Education: Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements.~The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning.~Group and individual components were included. Setting: secondary and high schools."
11266795|NCT02690168|BG000|Baseline|Healthy Men|Fasting: 72 hour fasting
11266796|NCT02690168|FG000|Participant Flow|Fasting|72 hour fasting
11266797|NCT02690168|OG000|Outcome|Healthy Men|Fasting: 72 hour fasting
11266798|NCT02690168|OG000|Outcome|Fasting|72 hour fasting
11266799|NCT02690168|EG000|Reported Event|Fasting|72 hour fasting
11266800|NCT02690181|BG000|Baseline|GBS NoAdj/GBS NoAdj Group|Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266801|NCT02690181|BG001|Baseline|GBS Alum/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266802|NCT02690181|BG002|Baseline|GBS MF59 Half/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266803|NCT02690181|BG003|Baseline|GBS MF59 Full/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266804|NCT02690181|BG004|Baseline|Placebo/GBS NoAdj Group|Subjects who had received placebo in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266805|NCT02690181|BG005|Baseline|Naive/GBS NoAdj Group|Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266806|NCT02690181|BG006|Baseline|Total|Total of all reporting groups
11266807|NCT02690181|FG000|Participant Flow|GBS NoAdj/GBS NoAdj Group|Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266808|NCT02690181|FG001|Participant Flow|GBS Alum/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266809|NCT02690181|FG002|Participant Flow|GBS MF59 Half/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266810|NCT02690181|FG003|Participant Flow|GBS MF59 Full/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266811|NCT02690181|FG004|Participant Flow|Placebo/GBS NoAdj Group|Subjects who had received placebo in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266812|NCT02690181|FG005|Participant Flow|Naive/GBS NoAdj Group|Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266813|NCT02690181|OG000|Outcome|GBS NoAdj/GBS NoAdj Group|Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266814|NCT02690181|OG001|Outcome|GBS Alum/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266815|NCT02690181|OG002|Outcome|GBS MF59 Half/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266816|NCT02690181|OG003|Outcome|GBS MF59 Full/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266817|NCT02690181|OG004|Outcome|Placebo/GBS NoAdj Group|Subjects who had received placebo in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
10970073|NCT00908791|EG000|Reported Event|Subjects Taking 1 or More Doses of CLA|Women with histologically proven invasive, non metastatic breast cancer who received at least one day of CLA.
11214033|NCT02289989|OG001|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214034|NCT02289989|EG000|Reported Event|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214035|NCT02289989|EG001|Reported Event|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
11214036|NCT02290028|BG000|Baseline|Sentus QP Left Ventricular Lead|Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
11214037|NCT02290028|FG000|Participant Flow|Sentus QP Left Ventricular Lead|Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D, plus participants that were consented but did not receive a Sentus QP lead or CRT-D.
11214038|NCT02290028|OG000|Outcome|Sentus QP Left Ventricular Lead|Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
11214039|NCT02290028|OG000|Outcome|Sentus QP L Model Left Ventricular Lead|Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.
11214040|NCT02290028|OG001|Outcome|Sentus QP S Model Left Ventricular Lead|Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
11214041|NCT02290028|OG001|Outcome|Sentus QP S Model Left Ventricular Lead|Participants consented and implanted with a Sentus QP S model left ventricular lead CRT-D.
11214042|NCT02290028|EG000|Reported Event|Sentus QP Left Ventricular Lead|Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
11214043|NCT02290106|BG000|Baseline|Pitavastatin|"pitavastatin 4mg daily by mouth for 6 months~pitavastatin"
11214044|NCT02290106|BG001|Baseline|Placebo|"Identical placebo 4mg by mouth daily for 6 months~PLACEBO"
11214045|NCT02290106|BG002|Baseline|Total|Total of all reporting groups
11214046|NCT02290106|FG000|Participant Flow|Pitavastatin|"pitavastatin 4mg daily by mouth for 6 months~pitavastatin"
11214047|NCT02290106|FG001|Participant Flow|Placebo|"Identical placebo 4mg by mouth daily for 6 months~PLACEBO"
11214048|NCT02290106|OG000|Outcome|Pitavastatin|"pitavastatin 4mg daily by mouth for 6 months~pitavastatin"
11214049|NCT02290106|OG001|Outcome|Placebo|"Identical placebo 4mg by mouth daily for 6 months~PLACEBO"
11214050|NCT02290106|EG000|Reported Event|Pitavastatin|"pitavastatin 4mg daily by mouth for 6 months~pitavastatin"
11214051|NCT02290106|EG001|Reported Event|Placebo|"Identical placebo 4mg by mouth daily for 6 months~PLACEBO"
11214052|NCT02290184|BG000|Baseline|Start With PilAm Go4Health Program|"Baseline to 3-months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor physical activity"
11214053|NCT02290184|BG001|Baseline|Start With Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214054|NCT02290184|BG002|Baseline|Total|Total of all reporting groups
11214055|NCT02290184|FG000|Participant Flow|Intervention Group - Start With PilAm Go4Health Intervention|"In the first 3 months intervention group start PilAm Go4Health lifestyle intervention. After initial 3-months participants will transition to a 3-month maintenance phase to maintain weight loss and learned lifestyle behaviors on their own. Group will complete the study at 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention promoting weight loss through physical activity and health diet using a mobile health app, pedometer to track daily step-counts, and social networking (in-person and Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on oral meds. Subjects will be asked: 1) log daily calorie/food intake and weekly wt. in mobile app diary and 2) wear a pedometer for 10hrs/day to monitor steps"
11266818|NCT02690181|OG005|Outcome|Naive/GBS NoAdj Group|Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266819|NCT02690181|EG000|Reported Event|GBS NoAdj/GBS NoAdj Group|Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266820|NCT02690181|EG001|Reported Event|GBS Alum/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266821|NCT02690181|EG002|Reported Event|GBS MF59 Half/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266822|NCT02690181|EG003|Reported Event|GBS MF59 Full/GBS NoAdj Group|Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266823|NCT02690181|EG004|Reported Event|Placebo/GBS NoAdj Group|Subjects who had received placebo in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266824|NCT02690181|EG005|Reported Event|Naive/GBS NoAdj Group|Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).
11266825|NCT02690194|BG000|Baseline|Placebo Group|"Pre-Placebo therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PLACEBO THERAPY SESSION~Post-Placebo therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Placebo Group: The placebo group will wear headphones and listen to nature sounds."
11266826|NCT02690194|BG001|Baseline|Experimental (Buddhify) Group|"Pre-Buddhify therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~BUDDHIFY THERAPY SESSION~Post-Buddhify therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions."
11266827|NCT02690194|BG002|Baseline|Control Group|"Pre-Procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure"
11266828|NCT02690194|BG003|Baseline|Total|Total of all reporting groups
11266829|NCT02690194|FG000|Participant Flow|Placebo Group|"Pre-Placebo therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PLACEBO THERAPY SESSION~Post-Placebo therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Placebo Group: The placebo group will wear headphones and listen to nature sounds."
11266830|NCT02690194|FG001|Participant Flow|Experimental (Buddhify) Group|"Pre-Buddhify therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~BUDDHIFY THERAPY SESSION~Post-Buddhify therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions."
11266831|NCT02690194|FG002|Participant Flow|Control Group|"Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure"
11266832|NCT02690194|OG000|Outcome|Placebo Group|"Pre-Placebo therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PLACEBO THERAPY SESSION~Post-Placebo therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Placebo Group: The placebo group will wear headphones and listen to nature sounds."
11266833|NCT02690194|OG001|Outcome|Experimental (Buddhify) Group|"Pre-Buddhify therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~BUDDHIFY THERAPY SESSION~Post-Buddhify therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions."
11266834|NCT02690194|OG002|Outcome|Control Group|"Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure"
11266835|NCT02690194|EG000|Reported Event|Placebo Group|"Pre-Placebo therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PLACEBO THERAPY SESSION~Post-Placebo therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Placebo Group: The placebo group will wear headphones and listen to nature sounds."
11266836|NCT02690194|EG001|Reported Event|Experimental (Buddhify) Group|"Pre-Buddhify therapy~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~BUDDHIFY THERAPY SESSION~Post-Buddhify therapy/Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure~Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions."
11266837|NCT02690194|EG002|Reported Event|Control Group|"Pre-procedure~Blood pressure, pulse, and respiration rate~State-Trait Anxiety Inventory~PROCEDURE~Post-procedure -Rate pain level of procedure"
11266838|NCT02690207|BG000|Baseline|HZ/su Group|Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11266839|NCT02690207|FG000|Participant Flow|HZ/su Group|Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11266840|NCT02690207|OG000|Outcome|HZ/su Group|Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11266841|NCT02690207|EG000|Reported Event|HZ/su Group|Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
11266842|NCT02690558|BG000|Baseline|Pembrolizumab, Gemcitabine and Cisplatin|"There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.~pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy"
11266843|NCT02690558|FG000|Participant Flow|Pembrolizumab, Gemcitabine and Cisplatin|"There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.~pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy"
11266844|NCT02690558|OG000|Outcome|Pembrolizumab, Gemcitabine and Cisplatin|"There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.~pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy"
11266845|NCT02690558|EG000|Reported Event|Pembrolizumab, Gemcitabine and Cisplatin|"There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.~pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy"
11266846|NCT02690649|BG000|Baseline|Health Messaging (Non-Procedural)|"PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle."
11266847|NCT02690649|BG001|Baseline|No Health Messaging|No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
11266848|NCT02690649|BG002|Baseline|Total|Total of all reporting groups
11266849|NCT02690649|FG000|Participant Flow|Health Messaging (Non-Procedural)|"PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle."
11266850|NCT02690649|FG001|Participant Flow|No Health Messaging|No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
11266851|NCT02690649|OG000|Outcome|Health Messaging (Non-Procedural)|"PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle."
11266852|NCT02690649|OG001|Outcome|No Health Messaging|No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
11266853|NCT02690649|OG000|Outcome|Health Messaging (Non-Procedural)|"PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use.~Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle."
11266854|NCT02690649|OG001|Outcome|No Health Messaging|"No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Standard care, training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use"
11266855|NCT02690649|EG000|Reported Event|Health Messaging (Non-Procedural)|"PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.~Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle."
11266856|NCT02690649|EG001|Reported Event|No Health Messaging|No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
11266857|NCT02690701|BG000|Baseline|Secukinumab|Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
11266858|NCT02690701|BG001|Baseline|Placebo|Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
11266859|NCT02690701|BG002|Baseline|Total|Total of all reporting groups
11266860|NCT02690701|FG000|Participant Flow|Secukinumab|Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
11266861|NCT02690701|FG001|Participant Flow|Placebo|Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
11266862|NCT02690701|OG000|Outcome|Secukinumab|Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
11266863|NCT02690701|OG001|Outcome|Placebo|Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
11266864|NCT02690701|EG000|Reported Event|Secukinumab 300 mg|Secukinumab 300 mg
11266865|NCT02690701|EG001|Reported Event|Placebo/Secukinumab 300 mg|Placebo/Secukinumab 300 mg
11266866|NCT02690701|EG002|Reported Event|Total|Total
11266867|NCT02690714|BG000|Baseline|6.6 mg/kg Plasminogen (Human) Intravenous|"6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion~Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3."
11266868|NCT02690714|FG000|Participant Flow|6.6 mg/kg Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous 6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks. Some subjects received more than 48 weeks of study drug.
11266869|NCT02690714|OG000|Outcome|Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
11266870|NCT02690714|OG000|Outcome|Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segment 2.
11266871|NCT02690714|OG000|Outcome|Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2,3 and post-week 48.
11266872|NCT02690714|OG000|Outcome|Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2, 3 and post-week 48.
11266873|NCT02690714|OG000|Outcome|Plasminogen (Human) Intravenous|Prometic Plasminogen (Human) intravenous Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segment 2.
11266874|NCT02690714|EG000|Reported Event|6.6 mg/kg Plasminogen (Human) Intravenous|"6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks (Norway) and longer until product licensing or study termination by the Sponsor (US).~Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3."
11266875|NCT02690727|BG000|Baseline|All Participants|"A single dose of RP6530 following fasting and Fed condition~RP6530: Single oral dose"
11266876|NCT02690727|FG000|Participant Flow|RP6530: Fast Condition First, Then Fed Condition|"Fast Condition first, then Fed Condition~RP6530: Single oral dose"
11266877|NCT02690727|FG001|Participant Flow|RP6530: Fed Condition First, Then Fast Condition|"Fed Condition first, then Fast Condition~RP6530: Single oral dose"
11266878|NCT02690727|OG000|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
11266879|NCT02690727|OG001|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
11266880|NCT02690727|OG000|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast Condition~RP6530: Single oral dose"
11266881|NCT02690727|OG001|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed Condition~RP6530: Single oral dose"
11266882|NCT02690727|EG000|Reported Event|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
11266883|NCT02690727|EG001|Reported Event|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
11266884|NCT02690935|BG000|Baseline|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
11266885|NCT02690935|BG001|Baseline|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
11266886|NCT02690935|BG002|Baseline|Total|Total of all reporting groups
11266887|NCT02690935|FG000|Participant Flow|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
11266888|NCT02690935|FG001|Participant Flow|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
11266889|NCT02690935|OG000|Outcome|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
11266890|NCT02690935|OG001|Outcome|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
11266891|NCT02690935|EG000|Reported Event|2LALERG|"Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH~Impregnated on lactose saccharose globules (380 mg/capsule)~2LALERG: Homeopathic drug"
11266892|NCT02690935|EG001|Reported Event|Placebo|"Non-impregnated lactose saccharose globules (380 mg/capsule)~Placebo: Placebo"
11266893|NCT02690948|BG000|Baseline|Pembrolizumab Monotherapy|"Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV"
11266894|NCT02690948|BG001|Baseline|Pembrolizumab Plus Vismodegib Combination Therapy|"Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Vismodegib: Given PO"
11266895|NCT02690948|BG002|Baseline|Total|Total of all reporting groups
11266896|NCT02690948|FG000|Participant Flow|Pembrolizumab Monotherapy|"Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV"
11266897|NCT02690948|FG001|Participant Flow|Pembrolizumab Plus Vismodegib Combination Therapy|"Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Vismodegib: Given PO"
11266898|NCT02690948|OG000|Outcome|Pembrolizumab Monotherapy|"Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV"
11266899|NCT02690948|OG001|Outcome|Pembrolizumab Plus Vismodegib Combination Therapy|"Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Vismodegib: Given PO"
11266900|NCT02690948|EG000|Reported Event|Pembrolizumab Monotherapy|"Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV"
11266901|NCT02690948|EG001|Reported Event|Pembrolizumab Plus Vismodegib Combination Therapy|"Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~Pembrolizumab: Given IV~Vismodegib: Given PO"
11266902|NCT02690974|BG000|Baseline|LCZ696 (Sacubitril / Valsartan)|All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
11266903|NCT02690974|FG000|Participant Flow|LCZ696 (Sacubitril / Valsartan)|All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
11266904|NCT02690974|OG000|Outcome|LCZ696 (Sacubitril / Valsartan)|All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
11266905|NCT02690974|EG000|Reported Event|LCZ696 (Sacubitril / Valsartan)|All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
11266906|NCT02691143|BG000|Baseline|Manipulation Plus Tape|"The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a Y strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal I strip applied at 50% tension at the site of pain."
11266907|NCT02691143|BG001|Baseline|Manipulation Only|The control group received manipulation from a licensed chiropractor only
11266908|NCT02691143|BG002|Baseline|Total|Total of all reporting groups
11266909|NCT02691143|FG000|Participant Flow|Manipulation Plus Tape|"The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a Y strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal I strip applied at 50% tension at the site of pain."
11266910|NCT02691143|FG001|Participant Flow|Manipulation Only|The control group received manipulation from a licensed chiropractor only
11266911|NCT02691143|OG000|Outcome|Manipulation Plus Tape|"The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a Y strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal I strip applied at 50% tension at the site of pain."
11266912|NCT02691143|OG001|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
11266913|NCT02691143|EG000|Reported Event|Manipulation Plus Tape|"The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a Y strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal I strip applied at 50% tension at the site of pain."
11266914|NCT02691143|EG001|Reported Event|Manipulation Only|The control group received manipulation from a licensed chiropractor only
11266915|NCT02691247|BG000|Baseline|CLBS03 Low Dose|"A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.~CLBS03 Low Dose"
11266916|NCT02691247|BG001|Baseline|CLBS03 High Dose|"A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.~CLBS03 High Dose"
11266917|NCT02691247|BG002|Baseline|Placebo|"A single infusion of placebo, consisting of the infusion solution only~Placebo"
11266918|NCT02691247|BG003|Baseline|Total|Total of all reporting groups
11266919|NCT02691247|FG000|Participant Flow|CLBS03 Low Dose|"A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.~CLBS03 Low Dose"
11266920|NCT02691247|FG001|Participant Flow|CLBS03 High Dose|"A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.~CLBS03 High Dose"
11266921|NCT02691247|FG002|Participant Flow|Placebo|"A single infusion of placebo, consisting of the infusion solution only~Placebo"
11266922|NCT02691247|OG000|Outcome|CLBS03 Low Dose|"A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.~CLBS03 Low Dose"
11266923|NCT02691247|OG001|Outcome|CLBS03 High Dose|"A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.~CLBS03 High Dose"
11266924|NCT02691247|OG002|Outcome|Placebo|"A single infusion of placebo, consisting of the infusion solution only~Placebo"
11266925|NCT02691247|EG000|Reported Event|CLBS03 Low Dose|"A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.~CLBS03 Low Dose"
11266926|NCT02691247|EG001|Reported Event|CLBS03 High Dose|"A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.~CLBS03 High Dose"
11266927|NCT02691247|EG002|Reported Event|Placebo|"A single infusion of placebo, consisting of the infusion solution only~Placebo"
11266928|NCT02691260|BG000|Baseline|no Incentives|Participants do not receive financial incentives.
11266929|NCT02691260|BG001|Baseline|Incentives for Dietary Self-monitoring|"Participants receive financial incentives for dietary self-monitoring.~incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application."
11266930|NCT02691260|BG002|Baseline|Incentives for Interim Weight Loss|"Participants receive financial incentives for interim weight loss.~incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly."
11266931|NCT02691260|BG003|Baseline|Incentives for Both|"Participants receive incentives for dietary self-monitoring and interim weight loss.~incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly."
11266932|NCT02691260|BG004|Baseline|Total|Total of all reporting groups
11266933|NCT02691260|FG000|Participant Flow|no Incentives|Participants do not receive financial incentives.
11266934|NCT02691260|FG001|Participant Flow|Incentives for Dietary Self-monitoring|"Participants receive financial incentives for dietary self-monitoring.~incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application."
11266935|NCT02691260|FG002|Participant Flow|Incentives for Interim Weight Loss|"Participants receive financial incentives for interim weight loss.~incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly."
11266936|NCT02691260|FG003|Participant Flow|Incentives for Both|"Participants receive incentives for dietary self-monitoring and interim weight loss.~incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly."
11266937|NCT02691260|OG000|Outcome|no Incentives|Participants do not receive financial incentives.
11266938|NCT02691260|OG001|Outcome|Incentives for Dietary Self-monitoring|"Participants receive financial incentives for dietary self-monitoring.~incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application."
11266939|NCT02691260|OG002|Outcome|Incentives for Interim Weight Loss|"Participants receive financial incentives for interim weight loss.~incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly."
11266940|NCT02691260|OG003|Outcome|Incentives for Both|"Participants receive incentives for dietary self-monitoring and interim weight loss.~incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly."
11266941|NCT02691260|EG000|Reported Event|no Incentives|Participants do not receive financial incentives.
11266942|NCT02691260|EG001|Reported Event|Incentives for Dietary Self-monitoring|"Participants receive financial incentives for dietary self-monitoring.~incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application."
11266943|NCT02691260|EG002|Reported Event|Incentives for Interim Weight Loss|"Participants receive financial incentives for interim weight loss.~incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly."
11266944|NCT02691260|EG003|Reported Event|Incentives for Both|"Participants receive incentives for dietary self-monitoring and interim weight loss.~incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly."
11266945|NCT02691416|BG000|Baseline|Propofol Postconditioning|1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
11266946|NCT02691416|BG001|Baseline|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
11266947|NCT02691416|BG002|Baseline|Total|Total of all reporting groups
11266948|NCT02691416|FG000|Participant Flow|Propofol Postconditioning|Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
11266949|NCT02691416|FG001|Participant Flow|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
11266950|NCT02691416|OG000|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
11266951|NCT02691416|OG001|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
11266952|NCT02691416|OG000|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
11266953|NCT02691416|OG000|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
11266954|NCT02691416|OG000|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
11266955|NCT02691416|OG000|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal"
11266956|NCT02691416|EG000|Reported Event|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
11266957|NCT02691416|EG001|Reported Event|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
11266958|NCT02691455|BG000|Baseline|Second Aqueous Shunt|"Second Aqueous Shunt~Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.~Baerveldt Glaucoma Implant 350-mm2 / BG101-350~Ahmed Model FP7 Flexible Plate~Baerveldt Glaucoma Implant 250-mm2 / BG103-250"
11266959|NCT02691455|BG001|Baseline|Transscleral Cyclophotocoagulation|"Transscleral Diode Laser Cyclophotocoagulation~Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard."
11266960|NCT02691455|BG002|Baseline|Total|Total of all reporting groups
11266961|NCT02691455|FG000|Participant Flow|Second Aqueous Shunt|"Second Aqueous Shunt~Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.~Baerveldt Glaucoma Implant 350-mm2 / BG101-350~Ahmed Model FP7 Flexible Plate~Baerveldt Glaucoma Implant 250-mm2 / BG103-250"
11266962|NCT02691455|FG001|Participant Flow|Transscleral Cyclophotocoagulation|"Transscleral Diode Laser Cyclophotocoagulation~Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard."
11266963|NCT02691455|OG000|Outcome|Second Aqueous Shunt|"Second Aqueous Shunt~Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.~Baerveldt Glaucoma Implant 350-mm2 / BG101-350~Ahmed Model FP7 Flexible Plate~Baerveldt Glaucoma Implant 250-mm2 / BG103-250"
11266964|NCT02691455|OG001|Outcome|Transscleral Cyclophotocoagulation|"Transscleral Diode Laser Cyclophotocoagulation~Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard."
11266965|NCT02691455|EG000|Reported Event|Second Aqueous Shunt|"Second Aqueous Shunt~Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.~Baerveldt Glaucoma Implant 350-mm2 / BG101-350~Ahmed Model FP7 Flexible Plate~Baerveldt Glaucoma Implant 250-mm2 / BG103-250"
11266966|NCT02691455|EG001|Reported Event|Transscleral Cyclophotocoagulation|"Transscleral Diode Laser Cyclophotocoagulation~Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard."
11266967|NCT02691468|BG000|Baseline|PVC DLT|"After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.~PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC"
11266968|NCT02691468|BG001|Baseline|Silicon DLT|"After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.~silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon"
11266969|NCT02691468|BG002|Baseline|Total|Total of all reporting groups
11266970|NCT02691468|FG000|Participant Flow|Polyvinyl Chloride (PVC) Double Lumen Tube (DLT)|"After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.~PVC DLT: PVC DLT is type of double lumen tube that is composed of polyvinlyl chloride."
11266971|NCT02691468|FG001|Participant Flow|Silicon Double Lumen Tube (DLT)|"After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.~silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon"
11266972|NCT02691468|OG000|Outcome|PVC DLT|"After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.~PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC"
11266973|NCT02691468|OG001|Outcome|Silicon DLT|"After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.~silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon"
11266974|NCT02691468|EG000|Reported Event|PVC DLT|"After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.~PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC"
11266975|NCT02691468|EG001|Reported Event|Silicon DLT|"After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.~The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .~The second set of measurements is taken in lateral position after position change.~The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.~silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon"
11266976|NCT02691494|BG000|Baseline|Placebo|Placebo for both elagolix BID and E2/NETA QD
11266977|NCT02691494|BG001|Baseline|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266978|NCT02691494|BG002|Baseline|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266979|NCT02691494|BG003|Baseline|Total|Total of all reporting groups
11266980|NCT02691494|FG000|Participant Flow|Placebo|Placebo for both elagolix BID and E2/NETA QD
11266981|NCT02691494|FG001|Participant Flow|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266982|NCT02691494|FG002|Participant Flow|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266983|NCT02691494|OG000|Outcome|Placebo|Placebo for both elagolix BID and E2/NETA QD
11266984|NCT02691494|OG001|Outcome|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266985|NCT02691494|OG002|Outcome|Elagolix + E2/NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266986|NCT02691494|EG000|Reported Event|Placebo|Placebo for both elagolix BID and E2/NETA QD
11266987|NCT02691494|EG001|Reported Event|Elagolix|Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266988|NCT02691494|EG002|Reported Event|Elagolix + E2-NETA|Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
11266989|NCT02691507|BG000|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
11266990|NCT02691507|BG001|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
11266991|NCT02691507|BG002|Baseline|Total|Total of all reporting groups
11266992|NCT02691507|FG000|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
11266993|NCT02691507|FG001|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
11266994|NCT02691507|OG000|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
11266995|NCT02691507|OG001|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
11266996|NCT02691507|EG000|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
11266997|NCT02691507|EG001|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
11266998|NCT02691572|BG000|Baseline|Wound Infiltration|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11266999|NCT02691572|BG001|Baseline|Transversus Abdominis Plane Block|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267000|NCT02691572|BG002|Baseline|Total|Total of all reporting groups
11267001|NCT02691572|FG000|Participant Flow|Wound Infiltration|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267002|NCT02691572|FG001|Participant Flow|Transversus Abdominis Plane Block|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267003|NCT02691572|OG000|Outcome|Wound Infiltration|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267004|NCT02691572|OG001|Outcome|Transversus Abdominis Plane Block|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267005|NCT02691572|EG000|Reported Event|Wound Infiltration|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267006|NCT02691572|EG001|Reported Event|Transversus Abdominis Plane Block|Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
11267007|NCT02691702|BG000|Baseline|Placebo (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267008|NCT02691702|BG001|Baseline|Melatonin 0.5 mg PM (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received melatonin 0.5 mg at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267009|NCT02691702|BG002|Baseline|PF-05251749 50 mg AM (Part A)|Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267010|NCT02691702|BG003|Baseline|PF-05251749 100 mg AM (Part A)|Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267011|NCT02691702|BG004|Baseline|PF-05251749 200 mg AM (Part A)|Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267012|NCT02691702|BG005|Baseline|PF-05251749 400 mg AM (Part A)|Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267013|NCT02691702|BG006|Baseline|PF-05251749 750 mg AM (Part A)|Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267014|NCT02691702|BG007|Baseline|Placebo (Part B)|Participants received placebo suspensions matched to PF-05251749 at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267015|NCT02691702|BG008|Baseline|PF-05251749 50 mg PM (Part B)|Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267016|NCT02691702|BG009|Baseline|PF-05251749 200 mg PM (Part B)|Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267017|NCT02691702|BG010|Baseline|PF-05251749 500 mg PM (Part B)|Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267018|NCT02691702|BG011|Baseline|Total|Total of all reporting groups
11267019|NCT02691702|FG000|Participant Flow|Placebo (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267020|NCT02691702|FG001|Participant Flow|Melatonin 0.5 mg PM (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received melatonin 0.5 mg at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267021|NCT02691702|FG002|Participant Flow|PF-05251749 50 mg AM (Part A)|Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267022|NCT02691702|FG003|Participant Flow|PF-05251749 100 mg AM (Part A)|Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267023|NCT02691702|FG004|Participant Flow|PF-05251749 200 mg AM (Part A)|Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267024|NCT02691702|FG005|Participant Flow|PF-05251749 400 mg AM (Part A)|Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267025|NCT02691702|FG006|Participant Flow|PF-05251749 750 mg AM (Part A)|Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267026|NCT02691702|FG007|Participant Flow|Placebo (Part B)|Participants received placebo suspensions matched to PF-05251749 at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267027|NCT02691702|FG008|Participant Flow|PF-05251749 50 mg PM (Part B)|Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267028|NCT02691702|FG009|Participant Flow|PF-05251749 200 mg PM (Part B)|Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267029|NCT02691702|FG010|Participant Flow|PF-05251749 500 mg PM (Part B)|Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267030|NCT02691702|OG000|Outcome|Placebo (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267031|NCT02691702|OG001|Outcome|Melatonin 0.5 mg PM (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received melatonin 0.5 mg at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267032|NCT02691702|OG002|Outcome|PF-05251749 50 mg AM (Part A)|Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267033|NCT02691702|OG003|Outcome|PF-05251749 100 mg AM (Part A)|Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267034|NCT02691702|OG004|Outcome|PF-05251749 200 mg AM (Part A)|Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267035|NCT02691702|OG005|Outcome|PF-05251749 400 mg AM (Part A)|Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267036|NCT02691702|OG006|Outcome|PF-05251749 750 mg AM (Part A)|Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267037|NCT02691702|OG007|Outcome|Placebo (Part B)|Participants received placebo suspensions matched to PF-05251749 at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267038|NCT02691702|OG008|Outcome|PF-05251749 50 mg PM (Part B)|Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267039|NCT02691702|OG009|Outcome|PF-05251749 200 mg PM (Part B)|Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267040|NCT02691702|OG010|Outcome|PF-05251749 500 mg PM (Part B)|Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267041|NCT02691702|OG000|Outcome|PF-05251749 50 mg AM (Part A)|Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267042|NCT02691702|OG001|Outcome|PF-05251749 100 mg AM (Part A)|Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267043|NCT02691702|OG002|Outcome|PF-05251749 200 mg AM (Part A)|Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267044|NCT02691702|OG003|Outcome|PF-05251749 400 mg AM (Part A)|Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267045|NCT02691702|OG004|Outcome|PF-05251749 750 mg AM (Part A)|Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267046|NCT02691702|OG005|Outcome|PF-05251749 50 mg PM (Part B)|Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
10970074|NCT00908830|BG000|Baseline|Cystic Fibrosis|"Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970075|NCT00908830|BG001|Baseline|Non-cystic Fibrosis Lung Transplant|"Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970076|NCT00908830|BG002|Baseline|Total|Total of all reporting groups
10970077|NCT00908830|FG000|Participant Flow|Cystic Fibrosis|"Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970078|NCT00908830|FG001|Participant Flow|Non-cystic Fibrosis Lung Transplant|"Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970079|NCT00908830|OG000|Outcome|Cystic Fibrosis|"Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970080|NCT00908830|OG001|Outcome|Non-cystic Fibrosis Lung Transplant|"Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
11267047|NCT02691702|OG006|Outcome|PF-05251749 200 mg PM (Part B)|Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267048|NCT02691702|OG007|Outcome|PF-05251749 500 mg PM (Part B)|Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
10970081|NCT00908830|EG000|Reported Event|Cystic Fibrosis|"Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970082|NCT00908830|EG001|Reported Event|Non-cystic Fibrosis Lung Transplant|"Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.~mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil"
10970083|NCT00908882|BG000|Baseline|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
10970084|NCT00908882|BG001|Baseline|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
10970085|NCT00908882|BG002|Baseline|Total|Total of all reporting groups
10970086|NCT00908882|FG000|Participant Flow|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
10970087|NCT00908882|FG001|Participant Flow|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
10970088|NCT00908882|OG000|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
10970089|NCT00908882|OG001|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
11267049|NCT02691702|EG000|Reported Event|Placebo (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267050|NCT02691702|EG001|Reported Event|Melatonin 0.5 mg PM (Part A)|Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received melatonin 0.5 mg at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267051|NCT02691702|EG002|Reported Event|PF-05251749 50 mg AM (Part A)|Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267052|NCT02691702|EG003|Reported Event|PF-05251749 100 mg AM (Part A)|Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267053|NCT02691702|EG004|Reported Event|PF-05251749 200 mg AM (Part A)|Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267054|NCT02691702|EG005|Reported Event|PF-05251749 400 mg AM (Part A)|Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267055|NCT02691702|EG006|Reported Event|PF-05251749 750 mg AM (Part A)|Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267056|NCT02691702|EG007|Reported Event|Placebo (Part B)|Participants received placebo suspensions matched to PF-05251749 at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267057|NCT02691702|EG008|Reported Event|PF-05251749 50 mg PM (Part B)|Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267058|NCT02691702|EG009|Reported Event|PF-05251749 200 mg PM (Part B)|Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267059|NCT02691702|EG010|Reported Event|PF-05251749 500 mg PM (Part B)|Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14.
11267060|NCT02691741|BG000|Baseline|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
11267061|NCT02691741|BG001|Baseline|839MP|AT LISA® tri IOL, bilateral implantation
11267062|NCT02691741|BG002|Baseline|Total|Total of all reporting groups
11267063|NCT02691741|FG000|Participant Flow|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
11267064|NCT02691741|FG001|Participant Flow|839MP|AT LISA® tri IOL, bilateral implantation
11267065|NCT02691741|OG000|Outcome|TFNT00|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
11267066|NCT02691741|OG001|Outcome|839MP|AT LISA® tri IOL, bilateral implantation
11267067|NCT02691741|EG000|Reported Event|TFNT00 - 1st Eye|First eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
11267068|NCT02691741|EG001|Reported Event|TFNT00 - 2nd Eye|Second eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
11267069|NCT02691741|EG002|Reported Event|TFNT00 - Systemic|Subjects implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in at least one eye
11267070|NCT02691741|EG003|Reported Event|839MP - 1st Eye|First eye implanted with AT LISA® tri IOL
11267071|NCT02691741|EG004|Reported Event|839MP - 2nd Eye|Second eye implanted with AT LISA® tri IOL
11267072|NCT02691741|EG005|Reported Event|839MP - Non-Study Eye|Eyes not meeting study inclusion/exclusion criteria
11267073|NCT02691741|EG006|Reported Event|839MP - Systemic|Subjects implanted with AT LISA® tri IOL in at least one eye
11267074|NCT02691936|BG000|Baseline|CO2 Fractionated Vaginal Laser|"Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.~CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months"
11267075|NCT02691936|BG001|Baseline|Estrogens, Conjugated (USP)|"The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.~Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks"
11267076|NCT02691936|BG002|Baseline|Total|Total of all reporting groups
11267077|NCT02691936|FG000|Participant Flow|CO2 Fractionated Vaginal Laser|"Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.~CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months"
11267078|NCT02691936|FG001|Participant Flow|Estrogens, Conjugated (USP)|"The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.~Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks"
11267079|NCT02691936|OG000|Outcome|CO2 Fractionated Vaginal Laser|"Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.~CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months"
11267080|NCT02691936|OG001|Outcome|Estrogens, Conjugated (USP)|"The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.~Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks"
11267081|NCT02691936|EG000|Reported Event|CO2 Fractionated Vaginal Laser|"Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.~CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months"
11267082|NCT02691936|EG001|Reported Event|Estrogens, Conjugated (USP)|"The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.~Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks"
11267083|NCT02691962|BG000|Baseline|Subjects Treated With XenMatrix AB|This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
11267084|NCT02691962|FG000|Participant Flow|Subjects Treated With Xen Matrix AB|This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
11267085|NCT02691962|OG000|Outcome|Xen Matrix AB|"Subjects treated with Xen Matrix AB~This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB."
11267086|NCT02691962|OG000|Outcome|Subjects Treated With Xen Matrix AB|This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
11267087|NCT02691962|EG000|Reported Event|Subjects Treated With Xen Matrix AB|This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
11267088|NCT02692040|BG000|Baseline|Placebo (A2-A11) - Saline|Single subcutaneous injection of 0.9% saline
11267089|NCT02692040|BG001|Baseline|G3215 Single Ascending Dose (A1)|Sequential cross-over group received either Saline or 0.1 mg dose G3215 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 0.5 mg dose G3215 single dose, subcutaneous injection in the second period, Saline or 1.5 mg dose G3215 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.
11267090|NCT02692040|BG002|Baseline|4 mg Dose G3215 (A2)|4 mg G3215 single dose, subcutaneous injection
11267091|NCT02692040|BG003|Baseline|4 mg Dose G3215 (A3)|4 mg G3215 single dose, subcutaneous injection
11267092|NCT02692040|BG004|Baseline|4 mg Dose G3215 (A4)|4 mg G3215 single dose, subcutaneous injection
11267093|NCT02692040|BG005|Baseline|4 mg Dose G3215 (A5)|4 mg G3215 single dose, subcutaneous injection
11267094|NCT02692040|BG006|Baseline|8 mg Dose G3215 (A7)|8 mg G3215 single dose, subcutaneous injection
11267095|NCT02692040|BG007|Baseline|10 mg Dose G3215 (A6)|10 mg G3215 single dose, subcutaneous injection
11267096|NCT02692040|BG008|Baseline|12 mg Dose G3215 (A8)|12 mg G3215 single dose, subcutaneous injection
11267097|NCT02692040|BG009|Baseline|16 mg Dose G3215 (A9)|16 mg G3215 single dose, subcutaneous injection
11267098|NCT02692040|BG010|Baseline|32 mg Dose G3215 (A10)|32 mg G3215 single dose, subcutaneous injection
11267099|NCT02692040|BG011|Baseline|48 mg Dose G3215 (A11)|48 mg G3215 single dose, subcutaneous injection
11267100|NCT02692040|BG012|Baseline|Placebo (B) - Saline|"0.9% saline multiple subcutaneous injection~5 injections over a 4 week treatment period~Placebo: 0.9% saline"
11267101|NCT02692040|BG013|Baseline|12-24 mg (B1) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 24 mg.~G3215: Gut hormone analogue"
11267102|NCT02692040|BG014|Baseline|6-10 mg (B2) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 10 mg.~G3215: Gut hormone analogue"
11267103|NCT02692040|BG015|Baseline|5-16 mg (B3) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 16 mg.~G3215: Gut hormone analogue"
11267104|NCT02692040|BG016|Baseline|3.2mg (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion over a 4 day treatment period at escalating doses to a max of 3.2 mg (with either the first or last day administering infusion of placebo [saline]).~G3215: Gut hormone analogue~Placebo: 0.9% saline"
11267105|NCT02692040|BG017|Baseline|Total|Total of all reporting groups
11267106|NCT02692040|FG000|Participant Flow|Placebo (A) - Saline|"0.9% saline single subcutaneous injection~Placebo: 0.9% saline"
11267107|NCT02692040|FG001|Participant Flow|G3215 Single Ascending Dose (A1)|Sequential cross-over group received either Saline or 0.1 mg dose G3215 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 0.5 mg dose G3215 single dose, subcutaneous injection in the second period, Saline or 1.5 mg dose G3215 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.
11267108|NCT02692040|FG002|Participant Flow|4 mg Dose G3215 (A2) With Varied Formulation|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267109|NCT02692040|FG003|Participant Flow|4 mg Dose G3215 (A3) With Varied Formulation|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267110|NCT02692040|FG004|Participant Flow|4 mg Dose G3215 (A4) With Varied Formulation|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267111|NCT02692040|FG005|Participant Flow|4 mg Dose G3215 (A5) With Varied Formulation|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267112|NCT02692040|FG006|Participant Flow|8 mg Dose G3215 (A7)|"8 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267113|NCT02692040|FG007|Participant Flow|10 mg Dose G3215 (A6)|"10 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267114|NCT02692040|FG008|Participant Flow|12 mg Dose G3215 (A8)|"12 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267115|NCT02692040|FG009|Participant Flow|16 mg Dose G3215 (A9)|"16 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267116|NCT02692040|FG010|Participant Flow|32 mg Dose G3215 (A10)|"32 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267117|NCT02692040|FG011|Participant Flow|48 mg Dose G3215 (A11)|"48 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267118|NCT02692040|FG012|Participant Flow|Placebo (B) - Saline|"0.9% saline multiple subcutaneous injection:~5 injections over a 4 week treatment period~Placebo: 0.9% saline"
11267119|NCT02692040|FG013|Participant Flow|12-24 mg (B1) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 24 mg.~G3215: Gut hormone analogue"
11267120|NCT02692040|FG014|Participant Flow|6-10 mg (B2) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 10 mg.~G3215: Gut hormone analogue"
11267121|NCT02692040|FG015|Participant Flow|5-16 mg (B3) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 16 mg.~G3215: Gut hormone analogue"
11267122|NCT02692040|FG016|Participant Flow|3.2mg (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion over a 4 day treatment period at escalating doses to a max of 3.2 mg (with either the first or last day administering infusion of placebo [saline]).~G3215: Gut hormone analogue~Placebo: 0.9% saline"
11267123|NCT02692040|OG000|Outcome|Placebo (A) - Saline|"0.9% saline single subcutaneous injection~Placebo: 0.9% saline"
11267124|NCT02692040|OG001|Outcome|0.1 mg Dose G3215 (A1)|"0.1 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267125|NCT02692040|OG002|Outcome|0.5 mg Dose G3215 (A1)|"0.5 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267126|NCT02692040|OG003|Outcome|1.5 mg Dose G3215 (A1)|"1.5 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267127|NCT02692040|OG004|Outcome|4 mg Dose G3215 (A2)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267128|NCT02692040|OG005|Outcome|4 mg Dose G3215 (A3)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267129|NCT02692040|OG006|Outcome|4 mg Dose G3215 (A4)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267130|NCT02692040|OG007|Outcome|4 mg Dose G3215 (A5)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267131|NCT02692040|OG008|Outcome|8 mg Dose G3215 (A7)|"8 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267132|NCT02692040|OG009|Outcome|10 mg Dose G3215 (A6)|"10 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267133|NCT02692040|OG010|Outcome|12 mg Dose G3215 (A8)|"12 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267134|NCT02692040|OG011|Outcome|16 mg Dose G3215 (A9)|"16 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267135|NCT02692040|OG012|Outcome|32 mg Dose G3215 (A10)|"32 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267136|NCT02692040|OG013|Outcome|48 mg Dose G3215 (A11)|"48 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267137|NCT02692040|OG014|Outcome|Placebo (B) - Saline|"0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period~Placebo: 0.9% saline"
11267138|NCT02692040|OG015|Outcome|5mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses~G3215: Gut hormone analogue"
11267139|NCT02692040|OG016|Outcome|6 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses~G3215: Gut hormone analogue"
11267140|NCT02692040|OG017|Outcome|7 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267141|NCT02692040|OG018|Outcome|8 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267142|NCT02692040|OG019|Outcome|10 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267143|NCT02692040|OG020|Outcome|12 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267144|NCT02692040|OG021|Outcome|16 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267145|NCT02692040|OG022|Outcome|20 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267146|NCT02692040|OG023|Outcome|24 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267147|NCT02692040|OG024|Outcome|Placebo (C)|Placebo: 0.9% saline
11267148|NCT02692040|OG025|Outcome|0.6 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 0.6 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267149|NCT02692040|OG026|Outcome|0.7 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 0.7 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267150|NCT02692040|OG027|Outcome|0.8 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 0.8 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267151|NCT02692040|OG028|Outcome|1 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 1 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267152|NCT02692040|OG029|Outcome|1.1 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 1.1 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267153|NCT02692040|OG030|Outcome|1.4 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 1.4 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267154|NCT02692040|OG031|Outcome|1.5 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 1.5 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267155|NCT02692040|OG032|Outcome|1.8 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 1.8 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267156|NCT02692040|OG033|Outcome|2.2 mg/24h (C) Infusion Pump Dose of G3215|"G3215 subcutaneous infusion of 2.2 mg over 24h treatment period.~G3215: Gut hormone analogue"
11267157|NCT02692040|OG000|Outcome|Placebo (A) - Saline|"0.9% saline~Placebo: 0.9% saline"
11267158|NCT02692040|OG014|Outcome|Placebo (B) - Saline|"0.9% saline~Placebo: 0.9% saline"
11267159|NCT02692040|OG015|Outcome|12-24 mg (B1) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 24 mg.~G3215: Gut hormone analogue"
11267160|NCT02692040|OG016|Outcome|6-10 mg (B2) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 10 mg.~G3215: Gut hormone analogue"
11267161|NCT02692040|OG017|Outcome|5-16 mg (B3) Dose of G3215|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses to a max of 16 mg.~G3215: Gut hormone analogue"
11267162|NCT02692040|OG018|Outcome|Infusion Pump Dose of G3215 (C)|"G3215 subcutaneous infusion over a 4 day treatment period at escalating doses to a max of 3.2 mg (with either the first or last day administering infusion of placebo [saline]).~G3215: Gut hormone analogue~Placebo: 0.9% saline"
11267163|NCT02692040|OG019|Outcome|Placebo (Part C)|Placebo infusion received on day 4 of infusion pump study
11267164|NCT02692040|EG000|Reported Event|Placebo (A) - Saline|"0.9% saline, single dose, subcutaneous injection~Placebo: 0.9% saline"
11267165|NCT02692040|EG001|Reported Event|0.1 mg Dose G3215 (A1)|"0.1 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267166|NCT02692040|EG002|Reported Event|0.5 mg Dose G3215 (A1)|"0.5 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267167|NCT02692040|EG003|Reported Event|1.5 mg Dose G3215 (A1)|"1.5 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267168|NCT02692040|EG004|Reported Event|4 mg Dose G3215 (A2)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267169|NCT02692040|EG005|Reported Event|4 mg Dose G3215 (A3)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267170|NCT02692040|EG006|Reported Event|4 mg Dose G3215 (A4)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267171|NCT02692040|EG007|Reported Event|4 mg Dose G3215 (A5)|"4 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267172|NCT02692040|EG008|Reported Event|8 mg Dose G3215 (A7)|"8 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267173|NCT02692040|EG009|Reported Event|10 mg Dose G3215 (A6)|"10 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267174|NCT02692040|EG010|Reported Event|12 mg Dose G3215 (A8)|"12 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267175|NCT02692040|EG011|Reported Event|16 mg Dose G3215 (A9)|"16 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267176|NCT02692040|EG012|Reported Event|32 mg Dose G3215 (A10)|"32 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267177|NCT02692040|EG013|Reported Event|48 mg Dose G3215 (A11)|"48 mg G3215 single dose, subcutaneous injection~G3215: Gut hormone analogue"
11267178|NCT02692040|EG014|Reported Event|Placebo (B) - Saline|"0.9% saline, multiple subcutaneous injections 5 injections over a 4 week treatment period~Placebo: 0.9% saline"
11267179|NCT02692040|EG015|Reported Event|5 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267180|NCT02692040|EG016|Reported Event|6 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267181|NCT02692040|EG017|Reported Event|7 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267182|NCT02692040|EG018|Reported Event|8 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267183|NCT02692040|EG019|Reported Event|10 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267184|NCT02692040|EG020|Reported Event|12 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267185|NCT02692040|EG021|Reported Event|16 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267186|NCT02692040|EG022|Reported Event|20 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267187|NCT02692040|EG023|Reported Event|24 mg G3215 (B)|"G3215 multiple dose, subcutaneous injection:~5 doses over a 4 week treatment period at escalating doses.~G3215: Gut hormone analogue"
11267188|NCT02692040|EG024|Reported Event|Placebo (C)|Placebo: 0.9% saline subcutaneous infusion over a 24 hour treatment period
11267189|NCT02692040|EG025|Reported Event|0.6 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 0.6 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267190|NCT02692040|EG026|Reported Event|0.7 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 0.7 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267191|NCT02692040|EG027|Reported Event|0.8 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 0.8 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267192|NCT02692040|EG028|Reported Event|1 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 1 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267193|NCT02692040|EG029|Reported Event|1.1 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 1.1 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267194|NCT02692040|EG030|Reported Event|1.4 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 1.4 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267195|NCT02692040|EG031|Reported Event|1.5 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 1.5 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267196|NCT02692040|EG032|Reported Event|1.8 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 1.8 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267197|NCT02692040|EG033|Reported Event|2.2 mg/24h (C) Infusion Rate Pump of G3215|"G3215 subcutaneous infusion of 2.2 mg over a 24 hour treatment period~G3215: Gut hormone analogue"
11267198|NCT02692209|BG000|Baseline|All 298 Cases/Study Participants|There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.
11267199|NCT02692209|FG000|Participant Flow|FFDM Alone Then FFDM Plus DBT|"FFDM images are being evaluated as compared to FFDM Plus DBT~FujiFilm Aspire Cristalle System~This is a sequential read, each reader read the case as a FFDM read followed by a FFDM plus DBT read"
11267200|NCT02692209|OG000|Outcome|FFDM Plus DBT|"FFDM Plus DBT images are being evaluated as compared to FFDM alone~FFDM Plus DBT: FFDM + DBT Images~FujiFilm Aspire Cristalle System"
11267201|NCT02692209|OG001|Outcome|Full Field Digital Mammography (FFDM)|"Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT~FFDM Alone: FFDM Alone Images"
11267202|NCT02692209|EG000|Reported Event|FFDM Plus DBT|"FFDM Plus DBT images are being evaluated as compared to FFDM alone~FFDM Plus DBT: FFDM + DBT Images~FujiFilm Aspire Cristalle System"
11267203|NCT02692209|EG001|Reported Event|Full Field Digital Mammography|"Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT~FFDM Alone: FFDM Alone Images"
11267204|NCT02692235|BG000|Baseline|Carnitine|"24 weeks l-carnitine-l-tartrate supplementation~carnitine: 1500 mg/d l-carnitine-l-tartrate"
11267205|NCT02692235|BG001|Baseline|Placebo|"24 weeks isonitrogenous supplementation~placebo: isonitrogenous"
11267206|NCT02692235|BG002|Baseline|Total|Total of all reporting groups
11267207|NCT02692235|FG000|Participant Flow|Carnitine|"24 weeks l-carnitine-l-tartrate supplementation~carnitine: 1500 mg/d l-carnitine-l-tartrate"
11267208|NCT02692235|FG001|Participant Flow|Placebo|"24 weeks isonitrogenous supplementation~placebo: isonitrogenous"
11267209|NCT02692235|OG000|Outcome|Carnitine|"24 weeks l-carnitine-l-tartrate supplementation~carnitine: 1500 mg/d l-carnitine-l-tartrate"
11267210|NCT02692235|OG001|Outcome|Placebo|"24 weeks isonitrogenous supplementation~placebo: isonitrogenous"
11267211|NCT02692235|EG000|Reported Event|Carnitine|"24 weeks l-carnitine-l-tartrate supplementation~carnitine: 1500 mg/d l-carnitine-l-tartrate"
11267212|NCT02692235|EG001|Reported Event|Placebo|"24 weeks isonitrogenous supplementation~placebo: isonitrogenous"
11267213|NCT02692391|BG000|Baseline|Placebo|"6 doses, Q8hrs for a total period of 48 hours~Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin"
11267214|NCT02692391|BG001|Baseline|Indomethacin Suppository|"Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)~Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours."
11267215|NCT02692391|BG002|Baseline|Total|Total of all reporting groups
11267216|NCT02692391|FG000|Participant Flow|Placebo|"6 doses, Q8hrs for a total period of 48 hours~Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin"
11267217|NCT02692391|FG001|Participant Flow|Indomethacin Suppository|"Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)~Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours."
11267218|NCT02692391|OG000|Outcome|Placebo|"6 doses, Q8hrs for a total period of 48 hours~Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin"
11267219|NCT02692391|OG001|Outcome|Indomethacin Suppository|"Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)~Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours."
11267220|NCT02692391|EG000|Reported Event|Placebo|"6 doses, Q8hrs for a total period of 48 hours~Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin"
11267221|NCT02692391|EG001|Reported Event|Indomethacin Suppository|"Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)~Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours."
11267222|NCT02692417|BG000|Baseline|Posterior Tibial Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267223|NCT02692417|BG001|Baseline|Dorsal Genital Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267224|NCT02692417|BG002|Baseline|Total|Total of all reporting groups
11267225|NCT02692417|FG000|Participant Flow|Posterior Tibial Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267226|NCT02692417|FG001|Participant Flow|Dorsal Genital Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267227|NCT02692417|OG000|Outcome|Posterior Tibial Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267228|NCT02692417|OG001|Outcome|Dorsal Genital Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267229|NCT02692417|EG000|Reported Event|Posterior Tibial Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267230|NCT02692417|EG001|Reported Event|Dorsal Genital Nerve Stimulation Group|"Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.~Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold."
11267231|NCT02692482|BG000|Baseline|Polyurethane Foam|"Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area~hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care"
11267232|NCT02692482|BG001|Baseline|Standard Care|standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
11267233|NCT02692482|BG002|Baseline|Total|Total of all reporting groups
11267234|NCT02692482|FG000|Participant Flow|Polyurethane Foam|"Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area~hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care"
11267235|NCT02692482|FG001|Participant Flow|Standard Care|standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
11267236|NCT02692482|OG000|Outcome|Polyurethane Foam|"Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area~hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care"
11267237|NCT02692482|OG001|Outcome|Standard Care|standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
11267238|NCT02692482|OG000|Outcome|Polyurethane Foam|"Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area~hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care~standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure."
11267239|NCT02692482|EG000|Reported Event|Polyurethane Foam|"Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area~hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care~standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure."
11267240|NCT02692482|EG001|Reported Event|Standard Care|standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
11267241|NCT02692495|BG000|Baseline|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
11267242|NCT02692495|BG001|Baseline|Halitosis|individuals with halitosis, not complaining of body odors
11267243|NCT02692495|BG002|Baseline|Total|Total of all reporting groups
11267244|NCT02692495|FG000|Participant Flow|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
11267245|NCT02692495|FG001|Participant Flow|Halitosis|individuals with halitosis (bad breath), not complaining of body odors
11267246|NCT02692495|OG000|Outcome|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
11267247|NCT02692495|OG001|Outcome|Halitosis|individuals with halitosis, not complaining of body odors
11267248|NCT02692495|OG000|Outcome|"Sour Group"|"Self-reported predominant odors included fishy, ammonia, sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic fecal odor"
11267249|NCT02692495|OG001|Outcome|"Sweet Group"|"Self-reported odors mostly identified as gas, benzene, burning,sulfur, rotten vegetables, rotten eggs, cheesy/sweaty and sulfury fecal, sewage, burning, and elusive odors that could not be smelled by the sufferer including PATM condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses)."
11267250|NCT02692495|OG002|Outcome|"Lactic Subgroup"|"Garbage odor identified as one of the most common types of odor (subgroup of the Sour cluster)"
11267251|NCT02692495|OG002|Outcome|"Lactic Subgroup"|"Garbage odor identified as one of the most common types of odor"
11267252|NCT02692495|EG000|Reported Event|Body Odor|individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis
11267253|NCT02692495|EG001|Reported Event|Halitosis|individuals self-reporting breath malodors but not body odors
11267254|NCT02692560|BG000|Baseline|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
11267255|NCT02692560|BG001|Baseline|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
11267256|NCT02692560|BG002|Baseline|Total|Total of all reporting groups
11267257|NCT02692560|FG000|Participant Flow|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
11286791|NCT02892513|FG001|Participant Flow|Inactive|"Participants will have inactive device worn for 5 days during and after elective surgery.~Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given."
11267258|NCT02692560|FG001|Participant Flow|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
11267259|NCT02692560|OG000|Outcome|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
11267260|NCT02692560|OG001|Outcome|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
11267261|NCT02692560|EG000|Reported Event|I-STAND|"Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.~I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time."
11267262|NCT02692560|EG001|Reported Event|Healthy Living|"Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.~Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees."
11267263|NCT02692586|BG000|Baseline|FlowTriever System|FlowTriever System
11267264|NCT02692586|FG000|Participant Flow|FlowTriever System|FlowTriever System
11267265|NCT02692586|OG000|Outcome|FlowTriever System|Patients treated with the FlowTriever System
11267266|NCT02692586|EG000|Reported Event|FlowTriever System|FlowTriever System
11267267|NCT02692703|BG000|Baseline|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11267268|NCT02692703|FG000|Participant Flow|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11267269|NCT02692703|OG000|Outcome|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11267270|NCT02692703|EG000|Reported Event|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
11267271|NCT02692716|BG000|Baseline|Oral Semaglutide|Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.
11267272|NCT02692716|BG001|Baseline|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
11267273|NCT02692716|BG002|Baseline|Total|Total of all reporting groups
11267274|NCT02692716|FG000|Participant Flow|Oral Semaglutide|Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.
11267275|NCT02692716|FG001|Participant Flow|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
11267276|NCT02692716|OG000|Outcome|Oral Semaglutide|Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.
11267277|NCT02692716|OG001|Outcome|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
11267278|NCT02692716|EG000|Reported Event|Oral Semaglutide|Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.
11267279|NCT02692716|EG001|Reported Event|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of upto 82 weeks.
11267280|NCT02692755|BG000|Baseline|Palbociclib + Letrozole or Fulvestrant|Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
11267281|NCT02692755|FG000|Participant Flow|Palbociclib + Letrozole or Fulvestrant|Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
11267282|NCT02692755|OG000|Outcome|Palbociclib + Letrozole or Fulvestrant|Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
11267283|NCT02692755|OG000|Outcome|Single ARM|"Palbociclib + Letrozole or Fulvestrant~Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months"
11267284|NCT02692755|EG000|Reported Event|Single ARM|"Palbociclib + Letrozole or Fulvestrant~Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months"
11267285|NCT02692859|BG000|Baseline|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
11267286|NCT02692859|BG001|Baseline|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
11267287|NCT02692859|BG002|Baseline|Total|Total of all reporting groups
11267288|NCT02692859|FG000|Participant Flow|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267289|NCT02692859|FG001|Participant Flow|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267290|NCT02692859|OG000|Outcome|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267291|NCT02692859|OG001|Outcome|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267292|NCT02692859|EG000|Reported Event|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267293|NCT02692859|EG001|Reported Event|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine~Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
11267294|NCT02693106|BG000|Baseline|Ketogenic Potential|"Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.~Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT"
11267295|NCT02693106|FG000|Participant Flow|Ketogenic Potential|"Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.~Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT"
11267296|NCT02693106|OG000|Outcome|Ketogenic Potential|"Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.~Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT"
11267297|NCT02693106|EG000|Reported Event|Control, no Supplement|Each visit corresponding to a standardize breakfast taken alone (control visit)followed by a period of 4-hour with multiple blood sampling.
11267298|NCT02693106|EG001|Reported Event|5g of Leucine|Each visit corresponding to a standardize breakfast taken with 5g of leucine followed by a period of 4-hour with multiple blood sampling.
11267299|NCT02693106|EG002|Reported Event|3.6g de Butyrate|Each visit corresponding to a standardize breakfast taken with 3.6g of butyrate followed by a period of 4-hour with multiple blood sampling.
11267300|NCT02693106|EG003|Reported Event|7.2g de Butyrate|Each visit corresponding to a standardize breakfast taken with 7.2g of butyrate followed by a period of 4-hour with multiple blood sampling.
11267301|NCT02693106|EG004|Reported Event|5g d'Octanoate|Each visit corresponding to a standardize breakfast taken with 5g of octanoate followed by a period of 4-hour with multiple blood sampling.
11267302|NCT02693106|EG005|Reported Event|10g d'Octanoate|Each visit corresponding to a standardize breakfast taken with 10g of octanoate followed by a period of 4-hour with multiple blood sampling.
11267303|NCT02693106|EG006|Reported Event|1.95g de Carnitine|Each visit corresponding to a standardize breakfast taken with 1.95g of carnitine followed by a period of 4-hour with multiple blood sampling.
11267304|NCT02693119|BG000|Baseline|Group 2|One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to a single eye and one drop of vehicle topical ophthalmic solution BID in the fellow eye.
11267305|NCT02693119|BG001|Baseline|Group 3|One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).
11267306|NCT02693119|BG002|Baseline|Total|Total of all reporting groups
11267307|NCT02693119|FG000|Participant Flow|Group 2|One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to a single eye and one drop of vehicle topical ophthalmic solution BID in the fellow eye
11267308|NCT02693119|FG001|Participant Flow|Group 3|One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).
11267309|NCT02693119|OG000|Outcome|Double Masked Group Vehicle Eyes|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267310|NCT02693119|OG001|Outcome|Double Masked Group Elamipretide Eyes|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267311|NCT02693119|OG000|Outcome|Vehicle Eyes: Mild|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267312|NCT02693119|OG001|Outcome|Vehicle Eyes: Moderate|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267313|NCT02693119|OG002|Outcome|Vehicle Eyes: Severe|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267314|NCT02693119|OG003|Outcome|Elamipretide Eyes: Mild|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267315|NCT02693119|OG004|Outcome|Elamipretide Eyes: Moderate|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267316|NCT02693119|OG005|Outcome|Elamipretide Eyes: Severe|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267317|NCT02693119|OG000|Outcome|Vehicle to Elamipretide Eyes: Mild|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267318|NCT02693119|OG001|Outcome|Vehicle to Elamipretide Eyes: Moderate|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267319|NCT02693119|OG002|Outcome|Vehicle to Elamipretide Eyes: Severe|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267320|NCT02693119|OG003|Outcome|Elamipretide to Elamipretide Eyes: Mild|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267321|NCT02693119|OG004|Outcome|Elamipretide to Elamipretide Eyes: Moderate|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267322|NCT02693119|OG005|Outcome|Elamipretide to Elamipretide Eyes: Severe|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267323|NCT02693119|OG000|Outcome|Vehicle to Elamipretide|4 participants who received vehicle in left eye during DM period, now received elamipretide. 4 participants who received vehicle in right eye during former DM period, now received elamipretide.
11267324|NCT02693119|OG001|Outcome|Elamipretide to Elamipretide|8 participants who received 1% elamipretide in left or right eye only during DM period, continued to receive 1% elamipretide in the eye. 4 participants who received 1% elamipretide in both eyes during former DM period, continued to receive 1% elamipretide in both eyes.
11267325|NCT02693119|OG000|Outcome|Vehicle Eyes|4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only
11267326|NCT02693119|OG001|Outcome|Elamipretide Eyes|4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes
11267327|NCT02693119|OG000|Outcome|Vehicle to Elamipretide Eyes|"Double Masked Period 4 participants received vehicle in the left eye only, 4 participants received 1% elamipretide in the right eye only~Open Label Period: All 12 participants received 1 drop of elamipretide 1.0% topical ophthalmic solution BID instilled into both eyes (Oculus Uterque [OU])."
11267328|NCT02693119|OG001|Outcome|Elamipretide to Elamipretide Eyes|"Double Masked Period: 4 participants received 1% elamipretide in the left eye only, 4 participants received 1% elamipretide in the right eye only, 4 participants received 1% elamipretide in both eyes~Open Label Period: All 12 participants received 1 drop of elamipretide 1.0% topical ophthalmic solution BID instilled into both eyes (Oculus Uterque [OU])."
11267329|NCT02693119|OG000|Outcome|Single Eye|Participants who received 1% elamipretide in one eye and control (placebo) in paired eye.
11267330|NCT02693119|OG001|Outcome|Bilateral Eye|Participants who received 1% elamipretide in both eyes.
11267331|NCT02693119|OG000|Outcome|Single Eye in DM Period|Participants who received 1% elamipretide BID in one eye and control (placebo) BID in paired eye in the DM Period, and then received 1% elamipretide BID in both eyes in the OLE Period.
11267332|NCT02693119|OG001|Outcome|Bilateral Eye in DM Period|"Elamipretide to Elamipretide Eyes~DM Period: 4 participants received 1% elamipretide in both eyes in DM Period and continued receiving 1% elamipretide in both eyes in the OLE Period"
11267333|NCT02693119|OG000|Outcome|Vehicle to Elamipretide Eyes|"Double Masked Period 4 participants received vehicle in the left eye only, 4 participants received vehicle in the right eye only.~Open Label Period: All 8 participants received 1 drop of elamipretide 1.0% topical ophthalmic solution BID instilled into both eyes (Oculus Uterque [OU])."
11267334|NCT02693119|OG001|Outcome|Elamipretide to Elamipretide Eyes|"DM Period: 4 participants received 1% elamipretide BID in the left eye only, 4 participants received 1% elamipretide BID in the right eye only, 4 participants received 1% elamipretide BID in both eyes.~OLE Period: All 8 participants received 1 drop of elamipretide 1.0% topical ophthalmic solution BID instilled into both eyes (Oculus Uterque [OU])."
11267335|NCT02693119|OG000|Outcome|Normal to Abnormal CS|Number of eyes shifting from normal to Abnormal clinically significant in slit lamp findings
11267336|NCT02693119|OG001|Outcome|Shift From Abnormal NCS to Abnormal CS|Number of eyes shifting from Abnormal nonclinically significant to abnormal clinically significant
11267337|NCT02693119|OG000|Outcome|Vehicle Eyes|Vehicle Eyes: Number of eyes shifting from normal or Abnormal- non clinically significant, to Abnormal clinically significant
11267338|NCT02693119|OG001|Outcome|Elamipretide Eyes|Elamipretide Eyes: Number of eyes shifting from normal or Abnormal-non clinically significant, to abnormal clinically significant
11267339|NCT02693119|EG000|Reported Event|One Eye DM Period|One eye Double Masked (DM) Period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to a single eye and one drop of vehicle topical ophthalmic solution BID in the fellow eye
11267340|NCT02693119|EG001|Reported Event|Both Eyes DM Period|Both eyes Double Masked (DM) One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU).
11267341|NCT02693119|EG002|Reported Event|(One Eye DM Period) OLE|Both eyes Open label Extension period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU) (and one eye in DM period)
11267342|NCT02693119|EG003|Reported Event|(Both Eyes DM) OLE Period|Both eyes Open label Extension period One drop elamipretide (MTP-131) 1% topical ophthalmic solution BID applied to both eyes (OU) (and both eyes in DM period)
11267343|NCT02693132|BG000|Baseline|Supervised (SUP-PA)|"Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.~Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity."
11267344|NCT02693132|BG001|Baseline|Unsupervised (UNSUP-PA)|"Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.~Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity."
11267345|NCT02693132|BG002|Baseline|Step-based (STEP)|"Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.~Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 brisk steps/day."
11267346|NCT02693132|BG003|Baseline|Total|Total of all reporting groups
11267347|NCT02693132|FG000|Participant Flow|Supervised (SUP-PA)|"Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.~Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity."
11267348|NCT02693132|FG001|Participant Flow|Unsupervised (UNSUP-PA)|"Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.~Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity."
10970090|NCT00908882|EG000|Reported Event|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
11267349|NCT02693132|FG002|Participant Flow|Step-based (STEP)|"Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.~Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 brisk steps/day."
11267350|NCT02693132|OG000|Outcome|Supervised (SUP-PA)|"Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.~Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity."
11267351|NCT02693132|OG001|Outcome|Unsupervised (UNSUP-PA)|"Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.~Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity."
11267352|NCT02693132|OG002|Outcome|Step-based (STEP)|"Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.~Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 brisk steps/day."
11267353|NCT02693132|EG000|Reported Event|Supervised (SUP-PA)|"Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.~Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity."
11267354|NCT02693132|EG001|Reported Event|Unsupervised (UNSUP-PA)|"Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.~Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity."
11267355|NCT02693132|EG002|Reported Event|Step-based (STEP)|"Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.~Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 brisk steps/day."
11267356|NCT02693262|BG000|Baseline|All Study Participants|All participants were randomized to receive all interventions, therefore baseline characteristics will be reported together.
11267357|NCT02693262|FG000|Participant Flow|CLS, Then DDDR|Participants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of CLS followed by 1 week of DDDR.
11267358|NCT02693262|FG001|Participant Flow|DDDR, Then CLS|Participants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of DDDR followed by 1 week of CLS.
11267359|NCT02693262|OG000|Outcome|CLS Mode on Biotronik CRT-D|"All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.~CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire."
11267360|NCT02693262|OG001|Outcome|Accelerometer Mode on Biotronik CRT-D|"All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.~Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire."
11267361|NCT02693262|EG000|Reported Event|CLS Mode on Biotronik CRT-D|"All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.~CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire."
11267362|NCT02693262|EG001|Reported Event|Accelerometer Mode on Biotronik CRT-D|"All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.~Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire."
11267363|NCT02693418|BG000|Baseline|Acidform Gel, Group A|"Administration of a single vaginal dose of Acidform gel (5 g)~Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days"
11267364|NCT02693418|BG001|Baseline|Acidform Gel, Group B|"Administration of a single vaginal dose of Acidform gel (4 g)~Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days"
11267365|NCT02693418|BG002|Baseline|Acidform Gel, Group C|"Administration of a single vaginal dose of Acidform gel (3 g)~Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days"
10970091|NCT00908882|EG001|Reported Event|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy
11267366|NCT02693418|BG003|Baseline|Placebo Gel, Group D|"Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)~Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days"
11267367|NCT02693418|BG004|Baseline|No Intervention, Group E|No vaginal product administered
11267368|NCT02693418|BG005|Baseline|Total|Total of all reporting groups
11267369|NCT02693418|FG000|Participant Flow|Acidform Gel, Group A|"Administration of a single vaginal dose of Acidform gel (5 g)~Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days"
11267370|NCT02693418|FG001|Participant Flow|Acidform Gel, Group B|"Administration of a single vaginal dose of Acidform gel (4 g)~Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days"
10970092|NCT00908895|BG000|Baseline|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
10970093|NCT00908895|BG001|Baseline|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
11267371|NCT02693418|FG002|Participant Flow|Acidform Gel, Group C|"Administration of a single vaginal dose of Acidform gel (3 g)~Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days"
11267372|NCT02693418|FG003|Participant Flow|Placebo Gel, Group D|"Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)~Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days"
11267373|NCT02693418|FG004|Participant Flow|No Intervention, Group E|No vaginal product administered
11267374|NCT02693418|OG000|Outcome|Acidform Gel, Group A|"Administration of a single vaginal dose of Acidform gel (5 g)~Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days"
11267375|NCT02693418|OG001|Outcome|Acidform Gel, Group B|"Administration of a single vaginal dose of Acidform gel (4 g)~Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days"
11267376|NCT02693418|OG002|Outcome|Acidform Gel, Group C|"Administration of a single vaginal dose of Acidform gel (3 g)~Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days"
11267377|NCT02693418|OG003|Outcome|Placebo Gel, Group D|"Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)~Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days"
11267378|NCT02693418|OG004|Outcome|No Intervention, Group E|No vaginal product administered
11267379|NCT02693418|EG000|Reported Event|Acidform Gel, Group A|"Administration of a single vaginal dose of Acidform gel (5 g)~Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days"
11267380|NCT02693418|EG001|Reported Event|Acidform Gel, Group B|"Administration of a single vaginal dose of Acidform gel (4 g)~Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days"
11267381|NCT02693418|EG002|Reported Event|Acidform Gel, Group C|"Administration of a single vaginal dose of Acidform gel (3 g)~Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days"
11267382|NCT02693418|EG003|Reported Event|Placebo Gel, Group D|"Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)~Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days"
11267383|NCT02693418|EG004|Reported Event|No Intervention, Group E|No vaginal product administered
11267384|NCT02693704|BG000|Baseline|Normal Hearing|People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
11286792|NCT02892513|OG000|Outcome|Active|"Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.~Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current."
10970094|NCT00908895|BG002|Baseline|Total|Total of all reporting groups
10970095|NCT00908895|FG000|Participant Flow|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
11267385|NCT02693704|BG001|Baseline|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267386|NCT02693704|BG002|Baseline|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267387|NCT02693704|BG003|Baseline|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267388|NCT02693704|BG004|Baseline|Total|Total of all reporting groups
11267389|NCT02693704|FG000|Participant Flow|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
11267390|NCT02693704|FG001|Participant Flow|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267391|NCT02693704|FG002|Participant Flow|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267392|NCT02693704|FG003|Participant Flow|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267393|NCT02693704|OG000|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
11267394|NCT02693704|OG001|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11286793|NCT02892513|OG001|Outcome|Inactive|"Participants will have inactive device worn for 5 days during and after elective surgery.~Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given."
11286794|NCT02892513|EG000|Reported Event|Active|"Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.~Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current."
11267395|NCT02693704|OG002|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267396|NCT02693704|OG003|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267397|NCT02693704|EG000|Reported Event|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
11267398|NCT02693704|EG001|Reported Event|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267399|NCT02693704|EG002|Reported Event|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267400|NCT02693704|EG003|Reported Event|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
11267401|NCT02693834|BG000|Baseline|Ankle Foot Orthosis|"Participants will be assigned to practice with Posterior Leaf spring AFO for a week, then they will be assigned to practice with Double adjustable AFO for another week.~Posterior Leaf spring AFO: Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.~Double adjustable AFO: Double adjustable AFO is a custom AFO with double action metal upright joints"
11267402|NCT02693834|FG000|Participant Flow|PLS AFO First Then DA AFO|At baseline Participants were assigned to wearing PLS AFO first for all measurements. Upon completion of baseline measurements,10 participants were randomly assigned to practice wearing the PLS AFO for the first week and the same participants were randomly assigned to the DA AFO for the second week
11267403|NCT02693834|FG001|Participant Flow|DA AFO First Then PLS AFO|At baseline Participants were assigned to wearing DA AFO first for all measurements. Upon completion of baseline measurements,11 participants were randomly assigned to practice wearing the DA AFO for the first week and the same 11 participants were randomly assigned to The PLS AFO for the second week. One person was lost to follow up in this group and so only 10 completed the protocol.
11267404|NCT02693834|OG000|Outcome|Ankle Foot Orthosis|At Baseline, all participants wore both AFOs in random order and gait endurance, gait velocity and gait symmetry were assessed and compared.
11267405|NCT02693834|OG000|Outcome|Ankle Foot Orthosis|"Participants will be assigned to practice with Posterior Leaf spring AFO for a week, then they will be assigned to practice with Double adjustable AFO for another week. The selection of AFO was randomized. Posterior Leaf spring AFO: Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.Double adjustable AFO: Double adjustable AFO is a custom AFO with double action metal upright joints.~10 participants wore the PLS AFO for the first week of practice and 10 participants wore the DA AFO for the first week."
11267406|NCT02693834|EG000|Reported Event|PLS AFO|Posterior Leaf Spring AFO
11267407|NCT02693834|EG001|Reported Event|DA AFO|Double Adjustable AFO
11267408|NCT02694029|BG000|Baseline|Arm 1: ABC, Then VRT|"Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH~Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH"
10970096|NCT00908895|FG001|Participant Flow|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
11267409|NCT02694029|BG001|Baseline|Arm 2: VisionRT, Then ABC|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH."
11267410|NCT02694029|BG002|Baseline|Total|Total of all reporting groups
11267411|NCT02694029|FG000|Participant Flow|Arm 1: ABC, Then VRT|"Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH~Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH"
11267412|NCT02694029|FG001|Participant Flow|Arm 2: VRT, Then ABC|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH."
11267413|NCT02694029|OG000|Outcome|Radiation With ABC|"Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH~Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH"
11267414|NCT02694029|OG001|Outcome|Radiation VRT|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH"
11267415|NCT02694029|OG001|Outcome|Radiation With VRT|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH"
11267416|NCT02694029|OG000|Outcome|Radiation With ABC|"Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH,~Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH"
11267417|NCT02694029|OG001|Outcome|Radiation With VisionRT|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH,~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH"
11267418|NCT02694029|OG001|Outcome|Radiation With VisionRT|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH"
11267419|NCT02694029|EG000|Reported Event|Radiation With ABC|"Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH~Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH"
11267420|NCT02694029|EG001|Reported Event|Radiation With VisionRT|"VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH~VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH."
11267421|NCT02694198|BG000|Baseline|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
11267422|NCT02694198|FG000|Participant Flow|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
11267423|NCT02694198|OG000|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
11267424|NCT02694198|EG000|Reported Event|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
11267425|NCT02694315|BG000|Baseline|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
11267426|NCT02694315|FG000|Participant Flow|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
10970097|NCT00908895|OG000|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
10970098|NCT00908895|OG001|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
11267427|NCT02694315|OG000|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
11267428|NCT02694315|EG000|Reported Event|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
11267429|NCT02694328|BG000|Baseline|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11267430|NCT02694328|BG001|Baseline|ALKS 3831|"Administered as a coated bilayer tablet~ALKS 3831: Daily dosing"
11267431|NCT02694328|BG002|Baseline|Total|Total of all reporting groups
11267432|NCT02694328|FG000|Participant Flow|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11267433|NCT02694328|FG001|Participant Flow|ALKS 3831|"Administered as a coated bilayer tablet~ALKS 3831: Daily dosing"
11267434|NCT02694328|OG000|Outcome|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11267435|NCT02694328|OG001|Outcome|ALKS 3831|"Administered as a coated bilayer tablet~ALKS 3831: Daily dosing"
11267436|NCT02694328|EG000|Reported Event|Olanzapine|"Administered as a coated bilayer tablet~Olanzapine: Daily dosing"
11267437|NCT02694328|EG001|Reported Event|ALKS 3831|"Administered as a coated bilayer tablet~ALKS 3831: Daily dosing"
10970099|NCT00908895|EG000|Reported Event|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
10970100|NCT00908895|EG001|Reported Event|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
10970101|NCT00908908|BG000|Baseline|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
10970102|NCT00908908|FG000|Participant Flow|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
11267438|NCT02694445|BG000|Baseline|Participant Patients|Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
11267439|NCT02694445|FG000|Participant Flow|Participant Patients|Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
11267440|NCT02694445|OG000|Outcome|Participant AD Patients|Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
11267441|NCT02694445|EG000|Reported Event|Participant Patients|Patient aged ≥60 years, inclusion criteria were: (1) a primary diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 13 diagnosed by a dementia specialist; (2) complete information about the economic costs of AD and comorbidities, obtained from electronic medical records systems and face-to-face interviews; and (3) no co-morbidity with direct medical cost > 10% of the total annual costs due to AD.
11267442|NCT02694523|BG000|Baseline|Adalimumab (Part A)|Participants randomized to receive double blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Weeks 0, 1, and every other week for 15 weeks (Part A).
11267443|NCT02694523|BG001|Baseline|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4 (Part A).
11267444|NCT02694523|BG002|Baseline|Total|Total of all reporting groups
11267445|NCT02694523|FG000|Participant Flow|Adalimumab (Part A)|Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
11267446|NCT02694523|FG001|Participant Flow|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11267447|NCT02694523|FG002|Participant Flow|Risankizumab/Risankizumab (Part B)|Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
11267448|NCT02694523|FG003|Participant Flow|Adalimumab/Adalimumab (Part B)|Participants who were responders after receiving adalimumab in Part A continued to receive adalimumab 40 mg by subcutaneous (SC) injection every other week through Week 41 (Part B).
11267449|NCT02694523|FG004|Participant Flow|Adalimumab/Risankizumab (Part B)|Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
11267450|NCT02694523|FG005|Participant Flow|Adalimumab/Rerandomized to Adalimumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
11267451|NCT02694523|FG006|Participant Flow|Adalimumab/Rerandomized to Risankizumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
11267452|NCT02694523|OG000|Outcome|Adalimumab (Part A)|Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
11267453|NCT02694523|OG001|Outcome|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11267454|NCT02694523|OG000|Outcome|Adalimumab/Rerandomized to Adalimumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
11267455|NCT02694523|OG001|Outcome|Adalimumab/Rerandomized to Risankizumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
11267456|NCT02694523|EG000|Reported Event|Adalimumab (Part A)|Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
11267457|NCT02694523|EG001|Reported Event|Risankizumab (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11267458|NCT02694523|EG002|Reported Event|Risankizumab/Risankizumab (Part B)|Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
11267459|NCT02694523|EG003|Reported Event|Adalimumab/Risankizumab (Part B)|Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
11267460|NCT02694523|EG004|Reported Event|Adalimumab/Rerandomized to Adalimumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
11267461|NCT02694523|EG005|Reported Event|Adalimumab/Rerandomized to Risankizumab (Part B)|Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
11267462|NCT02694536|BG000|Baseline|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
11267463|NCT02694536|FG000|Participant Flow|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
11267464|NCT02694536|OG000|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
11267465|NCT02694536|EG000|Reported Event|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
10970103|NCT00908908|OG000|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
11267466|NCT02694549|BG000|Baseline|CaveoVasc|Patients treated with CaveoVasc System
11267467|NCT02694549|FG000|Participant Flow|CaveoVasc|Patients treated with CaveoVasc System
11267468|NCT02694549|OG000|Outcome|CaveoVasc|Patients treated with CaveoVasc System
11267469|NCT02694549|EG000|Reported Event|CaveoVasc|Patients treated with CaveoVasc System
11267470|NCT02694562|BG000|Baseline|40um Embozene TANDEM Microspheres|"40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)~40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)."
11267471|NCT02694562|FG000|Participant Flow|40um Embozene TANDEM Microspheres|"40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)~40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)."
11267472|NCT02694562|OG000|Outcome|40um Embozene TANDEM Microspheres|"40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)~40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)."
11267473|NCT02694562|EG000|Reported Event|40um Embozene TANDEM Microspheres|"40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)~40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)."
11286795|NCT02892513|EG001|Reported Event|Inactive|"Participants will have inactive device worn for 5 days during and after elective surgery.~Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given."
10970104|NCT00908908|EG000|Reported Event|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
11267474|NCT02694601|BG000|Baseline|Ketonemia Following Caffeine Intake|"Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.~Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)"
11267475|NCT02694601|FG000|Participant Flow|Ketonemia Following Caffeine Intake|"Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.~Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)"
11267476|NCT02694601|OG000|Outcome|Ketonemia Following Caffeine Intake|"Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.~Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)"
11267477|NCT02694601|EG000|Reported Event|Ketonemia Following Caffeine Intake|"Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations.~Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)"
11267478|NCT02694718|BG000|Baseline|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
11267479|NCT02694718|FG000|Participant Flow|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
11267480|NCT02694718|OG000|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
11267481|NCT02694718|EG000|Reported Event|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
11267482|NCT02694744|BG000|Baseline|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
10970105|NCT00908947|BG000|Baseline|LifeStent|"Percutaneous trasluminal angioplasty (PTA) plus stenting with the LifeStent® Vascular Stent System~PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent"
10970106|NCT00908947|FG000|Participant Flow|LifeStent|Percutaneous Transluminal Angioplasty (PTA) followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
11267483|NCT02694744|BG001|Baseline|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally~*Note: Two randomized participants in Group 2 -Dosing With Food were excluded from the analyses for the intent-to-treat (ITT) population. One participant who did not receive any patiromer dose. Another participant had an important protocol violation and had no post-baseline serum K+, and was excluded from ITT prior to unblinding."
11267484|NCT02694744|BG002|Baseline|Total|Total of all reporting groups
11267485|NCT02694744|FG000|Participant Flow|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
11267486|NCT02694744|FG001|Participant Flow|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally"
11267487|NCT02694744|OG000|Outcome|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
11267488|NCT02694744|OG001|Outcome|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally"
11267489|NCT02694744|OG000|Outcome|Group 1|Patiromer without Food
11267490|NCT02694744|OG001|Outcome|Group 2|Patiromer with Food
11267491|NCT02694744|EG000|Reported Event|Group 1 - Dosing Without Food|"Patiromer dosing without food~patiromer: 8.4 g/day starting dose, administered orally"
11267492|NCT02694744|EG001|Reported Event|Group 2 - Dosing With Food|"Patiromer dosing with food~patiromer: 8.4 g/day starting dose, administered orally~*Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose."
11267493|NCT02694835|BG000|Baseline|DT1 UV|Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
11267494|NCT02694835|BG001|Baseline|Dailies Total1 (DT1)|Delefilcon A contact lenses worn bilaterally for 9 hours
11267495|NCT02694835|BG002|Baseline|Total|Total of all reporting groups
10970107|NCT00908947|OG000|Outcome|Overall Study|"PTA plus stenting with the LifeStent® Vascular Stent System~PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent"
11267496|NCT02694835|FG000|Participant Flow|DT1 UV|Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
11267497|NCT02694835|FG001|Participant Flow|Dailies Total1 (DT1)|Delefilcon A contact lenses worn bilaterally for 9 hours
11267498|NCT02694835|OG000|Outcome|DT1 UV|Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
11267499|NCT02694835|OG001|Outcome|Dailies Total1 (DT1)|Delefilcon A contact lenses worn bilaterally for 9 hours
11267500|NCT02694835|EG000|Reported Event|DT1 UV|Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
11267501|NCT02694835|EG001|Reported Event|Dailies Total1 (DT1)|Delefilcon A contact lenses worn bilaterally for 9 hours
11267502|NCT02694978|BG000|Baseline|Ferumoxytol|Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
11267503|NCT02694978|BG001|Baseline|Ferric Carboxymaltose (FCM)|Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
11267504|NCT02694978|BG002|Baseline|Total|Total of all reporting groups
11267505|NCT02694978|FG000|Participant Flow|Ferumoxytol|Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
11267506|NCT02694978|FG001|Participant Flow|Ferric Carboxymaltose (FCM)|Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
11267507|NCT02694978|OG000|Outcome|Ferumoxytol|Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
11267508|NCT02694978|OG001|Outcome|Ferric Carboxymaltose (FCM)|Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
11267509|NCT02694978|EG000|Reported Event|Ferumoxytol|Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
10970108|NCT00908947|OG000|Outcome|LifeStent|"PTA plus stenting with the LifeStent® Vascular Stent System~PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent"
11267510|NCT02694978|EG001|Reported Event|Ferric Carboxymaltose (FCM)|Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
11267511|NCT02695290|BG000|Baseline|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
11267512|NCT02695290|FG000|Participant Flow|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
11267513|NCT02695290|OG000|Outcome|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
11267514|NCT02695290|EG000|Reported Event|Afatinib|Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
11267515|NCT02695329|BG000|Baseline|Vanguard With KneeAlign 2|"Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.~KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation."
11267516|NCT02695329|BG001|Baseline|Vanguard Without KneeAlign 2|Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
11267517|NCT02695329|BG002|Baseline|Total|Total of all reporting groups
11267518|NCT02695329|FG000|Participant Flow|Vanguard With KneeAlign 2|"Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.~KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation."
11267519|NCT02695329|FG001|Participant Flow|Vanguard Without KneeAlign 2|Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
11267520|NCT02695329|OG000|Outcome|Vanguard With KneeAlign 2|"Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.~KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation."
11267521|NCT02695329|OG001|Outcome|Vanguard Without KneeAlign 2|Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
11267522|NCT02695329|EG000|Reported Event|Vanguard With KneeAlign 2|"Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.~KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation."
11267523|NCT02695329|EG001|Reported Event|Vanguard Without KneeAlign 2|Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
11267524|NCT02695420|BG000|Baseline|Placebo BID|Placebo for omecamtiv mecarbil BID
11267525|NCT02695420|BG001|Baseline|Omecamtiv Mecarbil 25 mg BID|Omecamtiv mecarbil 25 mg BID
11267526|NCT02695420|BG002|Baseline|Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose|Omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK
11267527|NCT02695420|BG003|Baseline|Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose|Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK
11267528|NCT02695420|BG004|Baseline|Total|Total of all reporting groups
11267529|NCT02695420|FG000|Participant Flow|Placebo BID|Placebo for omecamtiv mecarbil BID
11267530|NCT02695420|FG001|Participant Flow|Omecamtiv Mecarbil 25 mg BID|Omecamtiv mecarbil 25 mg BID
11267531|NCT02695420|FG002|Participant Flow|Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose|Omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK
11267532|NCT02695420|FG003|Participant Flow|Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose|Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK
11267533|NCT02695420|OG000|Outcome|Omecamtiv Mecarbil 25 mg BID|Omecamtiv mecarbil 25 mg BID
11267534|NCT02695420|OG001|Outcome|Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose|Omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK
11267535|NCT02695420|OG002|Outcome|Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose|Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK
11267536|NCT02695420|OG000|Outcome|Placebo BID|Placebo for omecamtiv mecarbil BID
11267537|NCT02695420|OG001|Outcome|Omecamtiv Mecarbil 25 mg BID|Omecamtiv mecarbil 25 mg BID
11267538|NCT02695420|OG002|Outcome|Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose|Omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK
11267539|NCT02695420|OG003|Outcome|Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose|Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK
11267540|NCT02695420|EG000|Reported Event|Placebo BID|Placebo for omecamtiv mecarbil BID
11267541|NCT02695420|EG001|Reported Event|Omecamtiv Mecarbil 25 mg BID|Omecamtiv mecarbil 25 mg BID
11267542|NCT02695420|EG002|Reported Event|Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose|Omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK
11267543|NCT02695420|EG003|Reported Event|Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose|Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK
11267544|NCT02695446|BG000|Baseline|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
11267545|NCT02695446|FG000|Participant Flow|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
11267546|NCT02695446|OG000|Outcome|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
11267547|NCT02695446|EG000|Reported Event|Oral ER Minocycline - Up to 2mg/kg|"Oral extended release minocycline - up to 2mg/kg once a day for 30 days.~Minocycline: Oral extended release minocycline"
11267548|NCT02695524|BG000|Baseline|Scapula-focused Exercises|"Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises"
11267549|NCT02695524|BG001|Baseline|Motor Control Exercises|"Towel slide, Scapular Clock, PNF scapular, Inferior Glide modified, Scapular Orientation Exercise, protraction and retraction of scapula, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises~Motor control exercises"
11267550|NCT02695524|BG002|Baseline|Total|Total of all reporting groups
11267551|NCT02695524|FG000|Participant Flow|Scapula-focused Exercises|"Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises"
11267552|NCT02695524|FG001|Participant Flow|Motor Control Exercises|"Towel slide, Scapular Clock, PNF scapular, Inferior Glide modified, Scapular Orientation Exercise, protraction and retraction of scapula, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises~Motor control exercises"
11267553|NCT02695524|OG000|Outcome|Scapula-focused Exercises|"Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises"
11267554|NCT02695524|OG001|Outcome|Motor Control Exercises|"Towel slide, Scapular Clock, PNF scapular, Inferior Glide modified, Scapular Orientation Exercise, protraction and retraction of scapula, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises~Motor control exercises"
11267555|NCT02695524|EG000|Reported Event|Scapula-focused Exercises|"Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises"
11267556|NCT02695524|EG001|Reported Event|Motor Control Exercises|"Towel slide, Scapular Clock, PNF scapular, Inferior Glide modified, Scapular Orientation Exercise, protraction and retraction of scapula, three times a week, 8 weeks, 3x10 repetitions~Scapula-focused exercises~Motor control exercises"
11267557|NCT02695537|BG000|Baseline|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11267558|NCT02695537|FG000|Participant Flow|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11267559|NCT02695537|OG000|Outcome|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11267560|NCT02695537|EG000|Reported Event|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11267561|NCT02695628|BG000|Baseline|Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)|"Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.~18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT~Arterial Embolization: Undergo transcatheter arterial embolization~Computed Tomography: Undergo [18F] FMISO PET/CT~Positron Emission Tomography: Undergo [18F] FMISO PET/CT"
11267562|NCT02695628|FG000|Participant Flow|Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)|"Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.~18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT~Arterial Embolization: Undergo transcatheter arterial embolization~Computed Tomography: Undergo [18F] FMISO PET/CT~Positron Emission Tomography: Undergo [18F] FMISO PET/CT"
11267563|NCT02695628|OG000|Outcome|Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)|"Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.~18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT~Arterial Embolization: Undergo transcatheter arterial embolization~Computed Tomography: Undergo [18F] FMISO PET/CT~Positron Emission Tomography: Undergo [18F] FMISO PET/CT"
11267564|NCT02695628|EG000|Reported Event|Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)|"Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.~18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT~Arterial Embolization: Undergo transcatheter arterial embolization~Computed Tomography: Undergo [18F] FMISO PET/CT~Positron Emission Tomography: Undergo [18F] FMISO PET/CT"
11267565|NCT02695719|BG000|Baseline|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267566|NCT02695719|BG001|Baseline|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267567|NCT02695719|BG002|Baseline|Total|Total of all reporting groups
11267568|NCT02695719|FG000|Participant Flow|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267569|NCT02695719|FG001|Participant Flow|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267570|NCT02695719|OG000|Outcome|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267571|NCT02695719|OG001|Outcome|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267572|NCT02695719|EG000|Reported Event|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267573|NCT02695719|EG001|Reported Event|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for up to 4 weeks
11267574|NCT02696070|BG000|Baseline|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
11267575|NCT02696070|BG001|Baseline|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
11267576|NCT02696070|BG002|Baseline|Total|Total of all reporting groups
11267577|NCT02696070|FG000|Participant Flow|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
11267578|NCT02696070|FG001|Participant Flow|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
11267579|NCT02696070|OG000|Outcome|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
11267580|NCT02696070|OG001|Outcome|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
11267581|NCT02696070|EG000|Reported Event|Sham of Provant|Inactive / sham Provant Therapy System. Subjects were instructed to treatment with an inactive Provant Therapy Unit that did not emit a pulsed electromagnet field.
11267582|NCT02696070|EG001|Reported Event|Active Treatment|Acitve Provant Therapy System. Subjects were instructed to treatment with an active Provant Therapy Unit that emitted a pulsed electromagnet field.
11267583|NCT02696083|BG000|Baseline|Active Treatment|Provant Therapy System
11267584|NCT02696083|FG000|Participant Flow|Active Treatment (Provant Therapy System)|Provant Therapy System
11267585|NCT02696083|OG000|Outcome|BMP and Related Proteins|BMP and related protein synovial markers measured included 9 markers: bone morphologic proteins (BMP-2, BMP-4, BMP-6, BMP-7, BMP-9) and related proteins Activin A, Osteoactivin (Ostact), sonic hedgehog (Shh N) and Dickkopf (DKK-1).
11267586|NCT02696083|OG001|Outcome|Cytokines|The 7 synovial markers measured included the levels of interleukin cytokines and tumor necrosis factor alpha (Il-1α, IL-1β, IL-6, IL-8, IL-11, IL-17 and TNFα),
11267587|NCT02696083|OG002|Outcome|Growth Factors and Related Proteins|The 10 synovial markers included in this group include Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1 (FGF-1, FGF-2, AR, PDGF BB, TGF b1, TGF b2, TGF b3, OPG, OPN and IGF-1
11267588|NCT02696083|OG003|Outcome|Bone Remodeling Related Proteins|The 6 synovial fluid markers in this group included monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine (MCP-1, M-CSF, MIP-1a, RANK, TRANCE).
11267589|NCT02696083|OG004|Outcome|Adhesion and Matrix Proteins|This group includes 4 adhesion and matrix metalloproteinase proteins: ICAM-1, P-CadH, VCAM-1, and VE-CadH.
11267590|NCT02696083|OG005|Outcome|MPP Proteins|The 4 matrix metalloproteinase proteins analyzed in this group include the following: MMP-2, MMP-3, MMP-9, and MMP-13.
11267591|NCT02696083|EG000|Reported Event|Active Treatment|Provant Therapy System
11267592|NCT02696200|BG000|Baseline|Subjects Wearing the Q Collar|"Subjects wearing the Q collar throughout the football season~Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt."
11267593|NCT02696200|BG001|Baseline|Subjects Not Wearing the Q Collar|Control group of subjects not wearing the q collar
11267594|NCT02696200|BG002|Baseline|Total|Total of all reporting groups
11267595|NCT02696200|FG000|Participant Flow|Subjects Wearing the Q Collar|"Subjects wearing the Q collar throughout the football season~Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt."
11267596|NCT02696200|FG001|Participant Flow|Subjects Not Wearing the Q Collar|Control group of subjects not wearing the q collar
11267597|NCT02696200|OG000|Outcome|Subjects Wearing the Q Collar|"Subjects wearing the Q collar throughout the football season~Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt."
11267598|NCT02696200|OG001|Outcome|Subjects Not Wearing the Q Collar|Control group of subjects not wearing the q collar
11267599|NCT02696200|EG000|Reported Event|Subjects Wearing the Q Collar|"Subjects wearing the Q collar throughout the football season~Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt."
11267600|NCT02696200|EG001|Reported Event|Subjects Not Wearing the Q Collar|Control group of subjects not wearing the q collar
11267601|NCT02696291|BG000|Baseline|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
11267602|NCT02696291|BG001|Baseline|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
11267603|NCT02696291|BG002|Baseline|Total|Total of all reporting groups
11267604|NCT02696291|FG000|Participant Flow|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
11267605|NCT02696291|FG001|Participant Flow|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
11267606|NCT02696291|OG000|Outcome|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
11267607|NCT02696291|OG001|Outcome|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
11267608|NCT02696291|EG000|Reported Event|Cohort 1 - 30 mg UV-4B|Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days
11267609|NCT02696291|EG001|Reported Event|Cohort 1 - Placebo|Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days
11267610|NCT02696317|BG000|Baseline|Overall|Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon A contact lenses in Periods 1 and 2, as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
11267611|NCT02696317|FG000|Participant Flow|Habitual, AO1D, AO|Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
11267612|NCT02696317|FG001|Participant Flow|Habitual, AO, AO1D|Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
11267613|NCT02696317|OG000|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
11267614|NCT02696317|OG001|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
11267615|NCT02696317|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to initiation of study treatment
11267616|NCT02696317|EG001|Reported Event|Habitual Lenses|All subjects exposed to habitual contact lenses during Period 1
11267617|NCT02696317|EG002|Reported Event|ACUVUE OASYS 1-DAY|All subjects exposed to ACUVUE OASYS 1-DAY contact lenses
11267618|NCT02696317|EG003|Reported Event|ACUVUE OASYS|All subjects exposed to ACUVUE OASYS contact lenses
11267619|NCT02696434|BG000|Baseline|NTX + BUP|"Naltrexone + buprenorphine~Naltrexone: daily dosing~Buprenorphine: daily dosing"
11267620|NCT02696434|BG001|Baseline|PBO NTX + BUP|"Placebo naltrexone + buprenorphine~Placebo: daily dosing~Buprenorphine: daily dosing"
11267621|NCT02696434|BG002|Baseline|Total|Total of all reporting groups
11267622|NCT02696434|FG000|Participant Flow|NTX + BUP|"Naltrexone + buprenorphine~Naltrexone: daily dosing~Buprenorphine: daily dosing"
11267623|NCT02696434|FG001|Participant Flow|PBO NTX + BUP|"Placebo naltrexone + buprenorphine~Placebo: daily dosing~Buprenorphine: daily dosing"
11267624|NCT02696434|OG000|Outcome|NTX + BUP|"Naltrexone + buprenorphine~Naltrexone: daily dosing~Buprenorphine: daily dosing"
11267625|NCT02696434|OG001|Outcome|PBO NTX + BUP|"Placebo naltrexone + buprenorphine~Placebo: daily dosing~Buprenorphine: daily dosing"
11267626|NCT02696434|EG000|Reported Event|NTX + BUP|"Naltrexone + buprenorphine~Naltrexone: daily dosing~Buprenorphine: daily dosing"
11267627|NCT02696434|EG001|Reported Event|PBO NTX + BUP|"Placebo naltrexone + buprenorphine~Placebo: daily dosing~Buprenorphine: daily dosing"
11267628|NCT02696785|BG000|Baseline|PBO/IXE|Participants received placebo every two weeks by subcutaneous injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by subcutaneous injection during extension treatment period.
11267629|NCT02696785|BG001|Baseline|ADA/IXE|Participants received 40mg Adalimumab every two weeks by SC injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period.
11267630|NCT02696785|BG002|Baseline|IXE80Q2W/IXE80Q2W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period.
11267631|NCT02696785|BG003|Baseline|IXE80Q4W/IXE80Q4W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period.
11267632|NCT02696785|BG004|Baseline|Total|Total of all reporting groups
11267633|NCT02696785|FG000|Participant Flow|PBO/IXE|"Blinded Treatment Period: Participants received placebo every two weeks by subcutaneous injection.~Extended Treatment Period: Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either every two weeks (Q2W) or every four weeks (Q4W) by subcutaneous (SC) injection during extended treatment period.~Participants did not receive any intervention during Follow-up period."
11267634|NCT02696785|FG001|Participant Flow|ADA/PBO/IXE|"Blinded Treatment Period:Participants received 40mg Adalimumab every two weeks by SC injection.~Washout Period: Participants received placebo for 6 weeks. Extended Treatment Period:Participants received 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period.~Participants did not receive any intervention during Follow-up period."
11267635|NCT02696785|FG002|Participant Flow|IXE80Q2W/IXE80Q2W|"Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period.~Participants did not receive any intervention during Follow-up period."
11267636|NCT02696785|FG003|Participant Flow|IXE80Q4W/IXE80Q4W|"Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period.~Participants did not receive any intervention during Follow-up period."
11267637|NCT02696785|OG000|Outcome|Placebo|Participants received placebo every two weeks by subcutaneous injection.
11267638|NCT02696785|OG001|Outcome|Adalimumab|Participants received 40mg Adalimumab every two weeks by SC injection.
11267639|NCT02696785|OG002|Outcome|IXE80Q4W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
11267640|NCT02696785|OG003|Outcome|IXE80Q2W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
11267641|NCT02696785|OG001|Outcome|Adalimumab 40mg|Participants received 40mg Adalimumab every two weeks by SC injection.
11267642|NCT02696785|OG000|Outcome|Placebo|Participants placebo every two weeks by subcutaneous injection.
11267643|NCT02696785|OG000|Outcome|Placebo/Ixekizumab|Participants received placebo every two weeks during blinded treatment period and starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either Q2W or Q4W extended treatment period by subcutaneous injection.
11267644|NCT02696785|OG001|Outcome|Adalimumab/Ixekizumab|Participants received 40mg Adalimumab every two weeks during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W during extended treatment period by subcutaneous injection.
10970109|NCT00908947|EG000|Reported Event|LifeStent|"PTA plus stenting with the LifeStent® Vascular Stent System~PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent"
11267645|NCT02696785|OG002|Outcome|Ixekizumab Q4W/Ixekizumab Q4W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection.
11267646|NCT02696785|OG003|Outcome|Ixekizumab 80mg Q2W/Ixekizumab 80mg Q2W|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection.
11267647|NCT02696785|OG000|Outcome|IXE80Q4W|Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.
11267648|NCT02696785|OG001|Outcome|IXE160/80Q4W|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
11267649|NCT02696785|OG002|Outcome|IXE80Q2W|Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.
11267650|NCT02696785|OG003|Outcome|IXE160/80Q2W|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
11267651|NCT02696785|EG000|Reported Event|Placebo - Blinded Treatment|Participants received placebo every two weeks by subcutaneous injection.
11267652|NCT02696785|EG001|Reported Event|Adalimumab 40mg - Blinded Treatment|Participants received 40mg Adalimumab every two weeks by SC injection.
11267653|NCT02696785|EG002|Reported Event|IXE80Q2W - Blinded Treatment|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
11267654|NCT02696785|EG003|Reported Event|IXE80Q4W - Blinded Treatment|Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
11267655|NCT02696785|EG004|Reported Event|ADA/PBO - Washout Treatment Period|Participants received placebo by subcutaneous injection
11267656|NCT02696785|EG005|Reported Event|PBO/IXE - Extended Treatment Period|Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Q2W or 80mg Q4W by subcutaneous injection.
11267657|NCT02696785|EG006|Reported Event|ADA/PBO/IXE - Extended Treatment Period|Participants received 80mg Ixekizumab Q2W or 80mg Q4W by subcutaneous injection.
11267658|NCT02696785|EG007|Reported Event|IXE80Q2W/IXE80Q2W - Extended Treatment|Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.
11267659|NCT02696785|EG008|Reported Event|IXE80Q4W/IXE80Q4W - Extended Treatment|Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.
11267660|NCT02696785|EG009|Reported Event|PBO-follow-up Period|Participants did not receive any intervention.
11267661|NCT02696785|EG010|Reported Event|IXE80Q2W-follow-up Period|Participants did not receive any intervention.
11267662|NCT02696785|EG011|Reported Event|IXE80Q4W-follow-up Period|Participants did not receive any intervention.
11267663|NCT02696798|BG000|Baseline|PBO/IXE|"Blinded Treatment Dosing Period: Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.~Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab 80 mg Q4W or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period~Participants did not receive any intervention during Follow-up period"
11267664|NCT02696798|BG001|Baseline|IXE80Q4W/IXE80Q4W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period~Participants did not receive any intervention during Follow-up period"
11267665|NCT02696798|BG002|Baseline|IXE80Q2W/IXE80Q2W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period~Participants did not receive any intervention during Follow-up period"
11267666|NCT02696798|BG003|Baseline|Total|Total of all reporting groups
11267667|NCT02696798|FG000|Participant Flow|PBO/IXE|"Blinded Treatment Dosing Period: Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.~Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab (IXE) 80 mg every four weeks (Q4W) or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period"
11267668|NCT02696798|FG001|Participant Flow|IXE80Q4W/IXE80Q4W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period"
11267669|NCT02696798|FG002|Participant Flow|IXE80Q2W/IXE80Q2W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.~Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period"
10970110|NCT00908960|BG000|Baseline|High TFMP: Enoxaparin|"Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).~Only patients with high TFMP status at baseline were randomized to treatment or observation."
11267670|NCT02696798|OG000|Outcome|Placebo|Participants received placebo every 2 weeks (Q2W) by subcutaneous injection.
11267671|NCT02696798|OG001|Outcome|80 mg Q4W Ixekizumab|Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
11267672|NCT02696798|OG002|Outcome|80 mg Q2W Ixekizumab|Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
10970111|NCT00908960|BG001|Baseline|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
11267673|NCT02696798|OG000|Outcome|Placebo|Participants received placebo every 2 weeks by subcutaneous injection.
11267674|NCT02696798|OG000|Outcome|PBO/IXE|"Blinded Treatment Dosing Period: Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.~Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab 80 mg Q4W or 80 mg Q2W at a 1:1 ratio."
11267675|NCT02696798|OG001|Outcome|IXE80Q4W/IXE80Q4W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52."
11267676|NCT02696798|OG002|Outcome|IXE80Q2W/IXE80Q2W|"Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.~Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52."
11267677|NCT02696798|OG000|Outcome|80 mg Q4W Ixekizumab (Starting Dose 80 mg)|Participants received 80 mg of Ixekizumab every four weeks by subcutaneous injection.
11267678|NCT02696798|OG001|Outcome|80 mg Q4W Ixekizumab (Starting Dose 160 mg)|Participants received 160 mg ixekizumab at baseline followed by 80 mg ixekizumab given SC every four weeks by subcutaneous injection.
11267679|NCT02696798|OG002|Outcome|80 mg Q2W Ixekizumab (Starting Dose 80 mg)|Participants received 80 mg ixekizumab every two weeks by subcutaneous injection.
11267680|NCT02696798|OG003|Outcome|80 mg Q2W Ixekizumab (Starting Dose 160 mg)|Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
11267681|NCT02696798|EG000|Reported Event|80 mg Q2W Ixekizumab-Blinded Treatment Period|Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
11267682|NCT02696798|EG001|Reported Event|80 mg Q4W Ixekizumab-Blinded Treatment Period|Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
11267683|NCT02696798|EG002|Reported Event|PBO-Blinded Treatment Period|Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
11267684|NCT02696798|EG003|Reported Event|IXE80Q2W/IXE80Q2W-Extended Treatment Period|Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
11267685|NCT02696798|EG004|Reported Event|IXE80Q4W/IXE80Q4W-Extended Treatment Period|Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
11267686|NCT02696798|EG005|Reported Event|PBO/IXE-Extended Treatment Period|Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
11267687|NCT02696798|EG006|Reported Event|IXE80Q2W-Follow-up Period|Participants did not receive any intervention during post-treatment follow-up period.
11267688|NCT02696798|EG007|Reported Event|IXE80Q4W-Follow-up Period|Participants did not receive any intervention during post-treatment follow-up period.
11267689|NCT02696798|EG008|Reported Event|PBO-Follow-up Period|Participants did not receive any intervention during post-treatment follow-up period.
11267690|NCT02696850|BG000|Baseline|Budesonide|"The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..~Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.~Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse."
11267691|NCT02696850|BG001|Baseline|Saline Alone|"Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.~Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse."
11267692|NCT02696850|BG002|Baseline|Total|Total of all reporting groups
11267693|NCT02696850|FG000|Participant Flow|Budesonide|"The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..~Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.~Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse."
11267694|NCT02696850|FG001|Participant Flow|Saline Alone|"Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.~Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse."
10970112|NCT00908960|BG002|Baseline|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
11267695|NCT02696850|OG000|Outcome|Budesonide|"The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..~Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.~Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse."
11267696|NCT02696850|OG001|Outcome|Saline Alone|"Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.~Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse."
11267697|NCT02696850|EG000|Reported Event|Budesonide|"The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..~Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.~Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse."
11286796|NCT02892734|BG000|Baseline|Treatment (Nivolumab, Ipilimumab)|"Patients receive nivolumab 240mg IV over 30 minutes Q2W for the first 16 weeks then 480mg IV every 4 weeks thereafter. Patients will Ipilimumab 1mg/kg IV over 90 minutes Q6W in the absence of disease progression or unacceptable toxicity. 1 Cycle = 12 weeks. Scans every 12 weeks for disease assessment.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
10970113|NCT00908960|BG003|Baseline|Total|Total of all reporting groups
11267698|NCT02696850|EG001|Reported Event|Saline Alone|"Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.~Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse."
11267699|NCT02696902|BG000|Baseline|Placebo|Of the 85 participants, 83 participants received single intravenous (IV) dose of placebo matched to MEDI3902.
11267700|NCT02696902|BG001|Baseline|MEDI3902 500 mg|Participants received single IV dose of 500 mg MEDI3902.
11267701|NCT02696902|BG002|Baseline|MEDI3902 1500 mg|Of the 87 participants, 85 participants received single IV dose of 1500 mg MEDI3902.
11267702|NCT02696902|BG003|Baseline|Total|Total of all reporting groups
11267703|NCT02696902|FG000|Participant Flow|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
11267704|NCT02696902|FG001|Participant Flow|MEDI3902 500 mg|Participants received single IV dose of 500 mg MEDI3902.
11267705|NCT02696902|FG002|Participant Flow|MEDI3902 1500 mg|Participants received single IV dose of 1500 mg MEDI3902.
11267706|NCT02696902|OG000|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
11267707|NCT02696902|OG001|Outcome|MEDI3902 500 mg|Participants received single IV dose of 500 mg MEDI3902.
10970114|NCT00908960|FG000|Participant Flow|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
11267708|NCT02696902|OG002|Outcome|MEDI3902 1500 mg|Participants received single IV dose of 1500 mg MEDI3902.
11267709|NCT02696902|OG000|Outcome|MEDI3902 500 mg|Participants received single IV dose of 500 mg MEDI3902.
11267710|NCT02696902|OG001|Outcome|MEDI3902 1500 mg|Participants received single IV dose of 1500 mg MEDI3902.
11267711|NCT02696902|EG000|Reported Event|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
11267712|NCT02696902|EG001|Reported Event|MEDI3902 500 mg|Participants received single IV dose of 500 mg MEDI3902.
11267713|NCT02696902|EG002|Reported Event|MEDI3902 1500 mg|Participants received single IV dose of 1500 mg MEDI3902.
11267714|NCT02696967|BG000|Baseline|CLR325 0.25 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner.
10970115|NCT00908960|FG001|Participant Flow|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
10970116|NCT00908960|FG002|Participant Flow|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
11267715|NCT02696967|BG001|Baseline|CLR325 2.5 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner.
11267716|NCT02696967|BG002|Baseline|CLR325 8 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner.
11267717|NCT02696967|BG003|Baseline|Placebo|Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner.
11267718|NCT02696967|BG004|Baseline|Total|Total of all reporting groups
10970117|NCT00908960|OG000|Outcome|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
11267719|NCT02696967|FG000|Participant Flow|CLR325 0.25 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner.
11267720|NCT02696967|FG001|Participant Flow|CLR325 2.5 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner.
11267721|NCT02696967|FG002|Participant Flow|CLR325 8 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner.
11267722|NCT02696967|FG003|Participant Flow|Placebo|Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner.
11267723|NCT02696967|OG000|Outcome|CLR325 0.25 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner.
11267724|NCT02696967|OG001|Outcome|CLR325 2.5 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner.
11267725|NCT02696967|OG002|Outcome|CLR325 8 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner.
11267726|NCT02696967|OG003|Outcome|Placebo|Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner.
11267727|NCT02696967|EG000|Reported Event|CLR325 0.25 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner.
11267728|NCT02696967|EG001|Reported Event|CLR325 2.5 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner.
11267729|NCT02696967|EG002|Reported Event|CLR325 8 mcg/kg/Min|Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner.
11267730|NCT02696967|EG003|Reported Event|Placebo|Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner.
11267731|NCT02697071|BG000|Baseline|Placebo Control|"Patients will receive an equivalent volume of normal saline intravenously.~Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267732|NCT02697071|BG001|Baseline|Ketamine|"Patients will receive 0.2mg/kg ketamine intravenously over one minute.~Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267733|NCT02697071|BG002|Baseline|Total|Total of all reporting groups
11267734|NCT02697071|FG000|Participant Flow|Placebo Control|"Patients will receive an equivalent volume of normal saline intravenously.~Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267735|NCT02697071|FG001|Participant Flow|Ketamine|"Patients will receive 0.2mg/kg ketamine intravenously over one minute.~Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267736|NCT02697071|OG000|Outcome|Placebo Control|"Patients will receive an equivalent volume of normal saline intravenously.~Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267737|NCT02697071|OG001|Outcome|Ketamine|"Patients will receive 0.2mg/kg ketamine intravenously over one minute.~Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267738|NCT02697071|EG000|Reported Event|Placebo Control|"Patients will receive an equivalent volume of normal saline intravenously.~Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267739|NCT02697071|EG001|Reported Event|Ketamine|"Patients will receive 0.2mg/kg ketamine intravenously over one minute.~Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration."
11267740|NCT02697188|BG000|Baseline|Testosterone Enanthate and Testosterone Undecanoate|"Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose) Testosterone enanthate: Single-day dose for 2 of 5 crossover periods~Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose) Testosterone undecanoate: Single-day dose as QD or BID for 3 of 5 crossover periods"
11267741|NCT02697188|FG000|Participant Flow|Testosterone Enanthate and Testosterone Undecanoate|Testosterone Enanthate Periods 1 and 5 Single-day dose as QD Period 1 and BID Period 5 Testosterone Undecanoate: Single-day dose as QD Period 2 and BID Periods 3 and 4
11267742|NCT02697188|OG000|Outcome|Testosterone Enanthate and Testosterone Undecanoate|"Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)~Testosterone enanthate: Single-day dose for 2 of 5 crossover periods Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose)~Testosterone undecanoate: Single-day dose as QD or BID for 3 of 5 crossover periods"
11267743|NCT02697188|EG000|Reported Event|Testosterone Enanthate 400 mg QD|Period 1: Testosterone Enanthate 400 mg QD
11267744|NCT02697188|EG001|Reported Event|Testosterone Undecanoate 200 mg QD|Period 2: Testosterone Undecanoate 200 mg QD
11267745|NCT02697188|EG002|Reported Event|Testosterone Undecanoate 100 mg BID|Period 3: Testosterone Undecanoate 100 mg BID
11267746|NCT02697188|EG003|Reported Event|Testosterone Undecanoate 200 mg BID|Period 4: Testosterone Undecanoate 200 mg BID
11267747|NCT02697188|EG004|Reported Event|Testosterone Enanthate 400 mg BID|Period 5: Testosterone Enanthate 400 mg BID
11267748|NCT02697214|BG000|Baseline|Apple Watch|"Apple Watch heart rate monitoring device.~Apple Watch: Apple Watch heart rate monitoring device."
11267749|NCT02697214|BG001|Baseline|Fitbit Charge HR|"Fitbit Charge HR heart rate monitoring device.~Fitbit Charge HR: Fitbit Charge HR heart rate monitoring device."
11267750|NCT02697214|BG002|Baseline|Mio Fuse|"Mio Fuse heart rate monitoring device.~Mio Fuse: Mio Fuse heart rate monitoring device."
11267751|NCT02697214|BG003|Baseline|Basis Peak|"Basis Peak heart rate monitoring device.~Basis Peak: Basis Peak heart rate monitoring device."
11267752|NCT02697214|BG004|Baseline|Total|Total of all reporting groups
11267753|NCT02697214|FG000|Participant Flow|Apple Watch|Participants wore Polar H7 chest monitor, standard ECG and Apple Watch and one other wrist monitor.
11267754|NCT02697214|FG001|Participant Flow|Fitbit Charge HR|Participants wore Polar H7 chest monitor, standard ECG and Fitbit Charge HR and one other wrist monitor.
11267755|NCT02697214|FG002|Participant Flow|Mio Fuse|Participants wore Polar H7 chest monitor, standard ECG and Mio Fuse and one other wrist monitor.
11267756|NCT02697214|FG003|Participant Flow|Basis Peak|Participants wore Polar H7 chest monitor and Basis Peak and one other wrist monitor.
11267757|NCT02697214|FG004|Participant Flow|Polar HR|All participants wore Polar HR chest monitor
11267758|NCT02697214|FG005|Participant Flow|Standard ECG|All participants wore standard ECG
11267759|NCT02697214|OG000|Outcome|Apple Watch|"Apple Watch heart rate monitoring device.~Apple Watch: Apple Watch heart rate monitoring device."
11267760|NCT02697214|OG001|Outcome|Fitbit Charge HR|"Fitbit Charge HR heart rate monitoring device.~Fitbit Charge HR: Fitbit Charge HR heart rate monitoring device."
11267761|NCT02697214|OG002|Outcome|Mio Fuse|"Mio Fuse heart rate monitoring device.~Mio Fuse: Mio Fuse heart rate monitoring device."
11267762|NCT02697214|OG003|Outcome|Basis Peak|"Basis Peak heart rate monitoring device.~Basis Peak: Basis Peak heart rate monitoring device."
11267763|NCT02697214|EG000|Reported Event|Apple Watch|"Apple Watch heart rate monitoring device.~Apple Watch: Apple Watch heart rate monitoring device."
11267764|NCT02697214|EG001|Reported Event|Fitbit Charge HR|"Fitbit Charge HR heart rate monitoring device.~Fitbit Charge HR: Fitbit Charge HR heart rate monitoring device."
11267765|NCT02697214|EG002|Reported Event|Mio Fuse|"Mio Fuse heart rate monitoring device.~Mio Fuse: Mio Fuse heart rate monitoring device."
11267766|NCT02697214|EG003|Reported Event|Basis Peak|"Basis Peak heart rate monitoring device.~Basis Peak: Basis Peak heart rate monitoring device."
11337553|NCT03587207|OG004|Outcome|MenACWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
11267767|NCT02697240|BG000|Baseline|Intravenous Citrulline|"Intravenous citrulline at a bolus dose over 5 minutes and then a continuous rate for the next 23 hours.~Intravenous citrulline: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants."
11267768|NCT02697240|FG000|Participant Flow|Intravenous Citrulline|"Intravenous citrulline at a bolus dose over 5 minutes and then a continuous rate for the next 23 hours.~Intravenous citrulline: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants."
11267769|NCT02697240|OG000|Outcome|Intravenous Citrulline|"Intravenous citrulline at a bolus dose over 5 minutes and then a continuous rate for the next 23 hours.~Intravenous citrulline: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants."
11267770|NCT02697240|EG000|Reported Event|Intravenous Citrulline|"Intravenous citrulline at a bolus dose over 5 minutes and then a continuous rate for the next 23 hours.~Intravenous citrulline: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants."
11267771|NCT02697292|BG000|Baseline|Placebo/Normal Saline Group|Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267772|NCT02697292|BG001|Baseline|Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group|Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
11267773|NCT02697292|BG002|Baseline|Total|Total of all reporting groups
11267774|NCT02697292|FG000|Participant Flow|Placebo/Normal Saline Group|Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267775|NCT02697292|FG001|Participant Flow|Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group|Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
11267776|NCT02697292|OG000|Outcome|Placebo/Normal Saline Group|Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267777|NCT02697292|OG001|Outcome|Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group|Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
11267778|NCT02697292|OG001|Outcome|Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group|Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267779|NCT02697292|EG000|Reported Event|Placebo/Normal Saline Group|Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267780|NCT02697292|EG001|Reported Event|Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group|Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
11267781|NCT02697435|BG000|Baseline|Patient-Centered Care|"Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.~Patient-Centered Care: Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs."
11267782|NCT02697435|BG001|Baseline|Imaging-Directed Care|"Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.~Imaging-Directed Care: Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all."
11267783|NCT02697435|BG002|Baseline|Total|Total of all reporting groups
11267784|NCT02697435|FG000|Participant Flow|Patient-Centered Care|"Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.~Patient-Centered Care: Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs."
11267785|NCT02697435|FG001|Participant Flow|Imaging-Directed Care|"Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.~Imaging-Directed Care: Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all."
11267786|NCT02697435|OG000|Outcome|Patient-Centered Care|Patient-Centered Care (i.e., ABC care): Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain in older adults. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.
11267787|NCT02697435|OG001|Outcome|Imaging-Directed Care|"Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.~Imaging-Directed Care: Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all."
11337554|NCT03587207|EG000|Reported Event|MenABCWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).
11267788|NCT02697435|OG000|Outcome|Patient-Centered Care|"Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.~Patient-Centered Care: Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs."
11267789|NCT02697435|EG000|Reported Event|Patient-Centered Care|"Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.~Patient-Centered Care: Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs."
11267790|NCT02697435|EG001|Reported Event|Imaging-Directed Care|"Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.~Imaging-Directed Care: Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all."
11267791|NCT02697591|BG000|Baseline|Phase 1: 0.03 mg/kg Q2W|INCAGN01876 was administered at 0.03mg/kg Q2W as part of dose escalation.
11267792|NCT02697591|BG001|Baseline|Phase 1: 0.1 mg/kg Q2W|INCAGN01876 was administered at 0.1mg/kg Q2W as part of dose escalation.
11267793|NCT02697591|BG002|Baseline|Phase 1: 0.3 mg/kg Q2W|INCAGN01876 was administered at 0.3mg/kg Q2W as part of dose escalation.
11267794|NCT02697591|BG003|Baseline|Phase 1: 1.0 mg/kg Q2W|INCAGN01876 was administered at 1.0mg/kg Q2W as part of dose escalation.
11267795|NCT02697591|BG004|Baseline|Phase 1: 3.0 mg/kg Q2W|INCAGN01876 was administered at 3mg/kg Q2W as part of dose escalation.
11267796|NCT02697591|BG005|Baseline|Phase 1: 5.0 mg/kg Q2W|INCAGN01876 was administered at 5mg/kg Q2W as part of dose escalation.
11267797|NCT02697591|BG006|Baseline|Phase 1: 10.0 mg/kg Q2W|INCAGN01876 was administered at 10mg/kg Q2W as part of dose escalation.
11267798|NCT02697591|BG007|Baseline|Phase 1: 20.0 mg/kg Q2W|INCAGN01876 was administered at 20mg/kg Q2W as part of dose escalation.
11267799|NCT02697591|BG008|Baseline|Phase 1: 400 mg Q4W|INCAGN01876 was administered at 400mg Q4W as part of dose escalation.
11267800|NCT02697591|BG009|Baseline|Phase 2: 300 mg Q2W|INCAGN01876 was administered at 300mg Q2W as part of dose escalation.
11267801|NCT02697591|BG010|Baseline|Total|Total of all reporting groups
11267802|NCT02697591|FG000|Participant Flow|Phase 1: 0.03 mg/kg Q2W|Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267803|NCT02697591|FG001|Participant Flow|Phase 1: 0.1 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267804|NCT02697591|FG002|Participant Flow|Phase 1: 0.3 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267805|NCT02697591|FG003|Participant Flow|Phase 1: 1.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267806|NCT02697591|FG004|Participant Flow|Phase 1: 3.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267807|NCT02697591|FG005|Participant Flow|Phase 1: 5.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
10970118|NCT00908960|OG001|Outcome|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
11267808|NCT02697591|FG006|Participant Flow|Phase 1: 10.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267809|NCT02697591|FG007|Participant Flow|Phase 1: 20.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267810|NCT02697591|FG008|Participant Flow|Phase 1: 400 mg Q4W|Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
11267811|NCT02697591|FG009|Participant Flow|Phase 2: 300 mg Q2W|Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
11267812|NCT02697591|OG000|Outcome|Phase 1: 0.03 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267813|NCT02697591|OG001|Outcome|Phase 1: 0.1 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267814|NCT02697591|OG002|Outcome|Phase 1: 0.3 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267815|NCT02697591|OG003|Outcome|Phase 1: 1.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267816|NCT02697591|OG004|Outcome|Phase 1: 3.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
10970119|NCT00908960|OG002|Outcome|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
10970120|NCT00908960|EG000|Reported Event|High TFMP: Enoxaparin|"Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).~Only patients with high TFMP status at baseline were randomized to treatment or observation."
11267817|NCT02697591|OG005|Outcome|Phase 1: 5.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267818|NCT02697591|OG006|Outcome|Phase 1: 10.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267819|NCT02697591|OG007|Outcome|Phase 1: 20.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267820|NCT02697591|OG008|Outcome|Phase 1: 400 mg Q4W|Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
11267821|NCT02697591|OG009|Outcome|Phase 2: 300 mg Q2W|Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
11267822|NCT02697591|EG000|Reported Event|Phase 1: 0.03 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267823|NCT02697591|EG001|Reported Event|Phase 1: 0.1 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267824|NCT02697591|EG002|Reported Event|Phase 1: 0.3 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267825|NCT02697591|EG003|Reported Event|Phase 1: 1.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
10970121|NCT00908960|EG001|Reported Event|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
10970122|NCT00908960|EG002|Reported Event|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
10970123|NCT00909038|BG000|Baseline|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
10970124|NCT00909038|FG000|Participant Flow|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
11267826|NCT02697591|EG004|Reported Event|Phase 1: 3.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
10970125|NCT00909038|OG000|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
11267827|NCT02697591|EG005|Reported Event|Phase 1: 5.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267828|NCT02697591|EG006|Reported Event|Phase 1: 10.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267829|NCT02697591|EG007|Reported Event|Phase 1: 20.0 mg/kg Q2W|Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
11267830|NCT02697591|EG008|Reported Event|Phase 1: 400 mg Q4W|Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
11267831|NCT02697591|EG009|Reported Event|Phase 2: 300 mg Q2W|Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
11267832|NCT02697591|EG010|Reported Event|Total|Total
11267833|NCT02697617|BG000|Baseline|All Study Participants|at randomization to sequence 1 (pioglitazone 15 mg) or placebo for cross over study
11267834|NCT02697617|FG000|Participant Flow|PIO Then PLACEBO|Sequence Pioglitazone then Placebo
11267835|NCT02697617|FG001|Participant Flow|Placebo Then PIO|sequence placebo then pioglitazone
11267836|NCT02697617|OG000|Outcome|Pioglitazone|Total body water
11267837|NCT02697617|OG001|Outcome|Placebo|Total Body Water
11267838|NCT02697617|OG000|Outcome|Pioglitazone 15 mg Daily|Patients who completed both arms, data from the 12 months of pioglitazone treatment
11267839|NCT02697617|OG001|Outcome|Placebo po Daily|of patients who finished both arms, the results from the placebo arm
11267840|NCT02697617|OG000|Outcome|Pioglitazone 15 mg|All patients taking pioglitazone
11267841|NCT02697617|OG001|Outcome|Placebo|all patients taking placebo
10970126|NCT00909038|EG000|Reported Event|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
11267842|NCT02697617|EG000|Reported Event|Pioglitazone|15 mg po daily
11267843|NCT02697617|EG001|Reported Event|Placebo|Over encapsulated (identical appearing) placebo
11267844|NCT02697734|BG000|Baseline|Osilodrostat Group|Participants in this arm were randomized to receive the study drug, osilodrostat, followed after Week 12 by open-label osilodrostat at the starting dose (with a second dose titration).
11267845|NCT02697734|BG001|Baseline|Osilodrostat Placebo Group|Participants in this arm were randomized to receive osilodrostat placebo followed after Week 12 by open-label osilodrostat at the starting dose (with a dose titration).
11267846|NCT02697734|BG002|Baseline|Total|Total of all reporting groups
11267847|NCT02697734|FG000|Participant Flow|Osilodrostat Group|Participants in this arm were randomized to receive the study drug, osilodrostat, followed after Week 12 by open-label osilodrostat at the starting dose (with a second dose titration).
11267848|NCT02697734|FG001|Participant Flow|Osilodrostat Placebo Group|Participants in this arm were randomized to receive osilodrostat placebo followed after Week 12 by open-label osilodrostat at the starting dose (with a dose titration).
11267849|NCT02697734|OG000|Outcome|Osilodrostat Group|Participants in this arm were randomized to receive the study drug, osilodrostat, followed after Week 12 by open-label osilodrostat at the starting dose (with a second dose titration).
11267850|NCT02697734|OG001|Outcome|Osilodrostat Placebo Group|Participants in this arm were randomized to receive osilodrostat placebo followed after Week 12 by open-label osilodrostat at the starting dose (with a dose titration).
11267851|NCT02697734|OG000|Outcome|All Participants Combined|Consisted of all randomized participants who received at least one dose of osilodrostat.
11267852|NCT02697734|OG002|Outcome|All Participants|All Participants
11267853|NCT02697734|OG000|Outcome|Osilodrostat Incident Dose 1mg|Participants received 1mg of osilodrostat.
11267854|NCT02697734|OG001|Outcome|Osilodrostat Incident Dose 2mg|Participants received 2mg of osilodrostat.
11267855|NCT02697734|OG002|Outcome|Osilodrostat Incident Dose 5mg|Participants received 5mg of osilodrostat.
11267856|NCT02697734|EG000|Reported Event|Placebo Controlled Period - Osilodrostat Arm.|All data while on osilodrostat treatment up to week 12 in participants initially randomized to osilodrostat.
11267857|NCT02697734|EG001|Reported Event|Placebo Controlled Period - Placebo Arm.|All data while on placebo treatment up to week 12 in participants initially randomized to placebo.
11267858|NCT02697734|EG002|Reported Event|Overall Study Period - Osilodrostat Arm.|All data while on osilodrostat treatment from randomization up to end-of-study in participants initially randomized to osilodrostat.
11267859|NCT02697734|EG003|Reported Event|Overall Study Period - Placebo Arm.|All data while on osilodrostat treatment from Week 12 up to end-of-study in participants initially randomized to placebo.
11267860|NCT02697734|EG004|Reported Event|Overall Study Period - All Participants.|All data while on osilodrostat treatment up to end-of-study in all randomized participants, excluding data while on placebo from participants initially randomized to placebo.
11267861|NCT02697773|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267862|NCT02697773|BG001|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267863|NCT02697773|BG002|Baseline|Tanezumab 2.5mg/5mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Tanezumab 5 mg injection administered subcutaneously on Week 8.
11267864|NCT02697773|BG003|Baseline|Total|Total of all reporting groups
11267865|NCT02697773|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267866|NCT02697773|FG001|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267867|NCT02697773|FG002|Participant Flow|Tanezumab 2.5/5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
11267868|NCT02697773|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267869|NCT02697773|OG001|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267870|NCT02697773|OG002|Outcome|Tanezumab 2.5/5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
11267871|NCT02697773|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267872|NCT02697773|EG001|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8.
11267873|NCT02697773|EG002|Reported Event|Tanezumab 2.5/5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and 5 mg injection administered subcutaneously on Week 8.
11267874|NCT02697890|BG000|Baseline|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
11267875|NCT02697890|BG001|Baseline|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
11267876|NCT02697890|BG002|Baseline|Total|Total of all reporting groups
11267877|NCT02697890|FG000|Participant Flow|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
11267878|NCT02697890|FG001|Participant Flow|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
11267879|NCT02697890|OG000|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
11267880|NCT02697890|OG001|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
11267881|NCT02697890|EG000|Reported Event|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
11267882|NCT02697890|EG001|Reported Event|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
11267883|NCT02697916|BG000|Baseline|ASA 81mg|"aspirin 81mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267884|NCT02697916|BG001|Baseline|ASA 325mg|"aspirin 325mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267885|NCT02697916|BG002|Baseline|Total|Total of all reporting groups
11267886|NCT02697916|FG000|Participant Flow|ASA 81mg|"aspirin 81mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267887|NCT02697916|FG001|Participant Flow|ASA 325mg|"aspirin 325mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267888|NCT02697916|OG000|Outcome|ASA 81mg|"aspirin 81mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267889|NCT02697916|OG001|Outcome|ASA 325mg|"aspirin 325mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267890|NCT02697916|EG000|Reported Event|ASA 81mg|"aspirin 81mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267891|NCT02697916|EG001|Reported Event|ASA 325mg|"aspirin 325mg~aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily"
11267892|NCT02698033|BG000|Baseline|Peanut Flour|"Double-blind food challenge with peanut flour~Peanut flour: A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly."
11267893|NCT02698033|FG000|Participant Flow|Peanut Flour|"Double Blind Oral food challenge to peanut~Peanut flour: A food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly."
11267894|NCT02698033|OG000|Outcome|Peanut Flour|"Double-blind food challenge with peanut flour~Peanut flour: A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly."
11267895|NCT02698033|EG000|Reported Event|Peanut Flour|"Double-blind food challenge with peanut flour~Peanut flour: A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly."
11267896|NCT02698176|BG000|Baseline|MK-8628 20 mg CRPC Cohort-Part A|Participants in the CRPC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267897|NCT02698176|BG001|Baseline|MK-8628 20 mg NMC Cohort-Part A|Participants in the NMC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267898|NCT02698176|BG002|Baseline|MK-8628 20 mg TNBC Cohort-Part A|Participants in the TNBC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267899|NCT02698176|BG003|Baseline|Total|Total of all reporting groups
11267900|NCT02698176|FG000|Participant Flow|MK-8628 20 mg CRPC Cohort-Part A|Participants in the CRPC cohort in Part A of the study received MK-8628 20 mg orally (PO), twice a day (BID), in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267901|NCT02698176|FG001|Participant Flow|MK-8628 20 mg NMC Cohort-Part A|Participants in the NMC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267902|NCT02698176|FG002|Participant Flow|MK-8628 20 mg TNBC Cohort-Part A|Participants in the TNBC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267903|NCT02698176|FG003|Participant Flow|NMC Cohort-Part B|Participants (up to 30) in Part B were to receive MK-8628 at one dose level below the dose that was currently being administered in the escalation portion of Part A of the study. Once the recommended Phase 2 dose (RP2D) from Part A was established, participants in Part B were to receive MK-8628 at the RP2D. Participants were to continue receiving MK-8628 at an assigned/adjusted dose level for continuous cycles up to 24 months.
11267904|NCT02698176|OG000|Outcome|MK-8628 20 mg CRPC Cohort-Part A|Participants in the CRPC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
10970127|NCT00909064|BG000|Baseline|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
11267905|NCT02698176|OG001|Outcome|MK-8628 20 mg NMC Cohort-Part A|Participants in the NMC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267906|NCT02698176|OG002|Outcome|MK-8628 20 mg TNBC Cohort-Part A|Participants in the TNBC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267907|NCT02698176|OG003|Outcome|NMC Cohort-Part B|Participants (up to 30) in Part B were to receive MK-8628 at one dose level below the dose that was currently being administered in the escalation portion of Part A of the study. Once the recommended Phase 2 dose (RP2D) from Part A was established, participants in Part B were to receive MK-8628 at the RP2D. Participants were to continue receiving MK-8628 at an assigned/adjusted dose level for continuous cycles up to 24 months.
11267908|NCT02698176|OG000|Outcome|MK-8628 20 mg PK Cohort|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg PO, BID, in a fasted state.
11267909|NCT02698176|OG000|Outcome|MK-8628 20 mg DLT Cohort|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg PO, BID, in a fasted state.
11267910|NCT02698176|EG000|Reported Event|MK-8628 20 mg CRPC Cohort-Part A|Participants in the CRPC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267911|NCT02698176|EG001|Reported Event|MK-8628 20 mg NMC Cohort-Part A|Participants in the NMC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267912|NCT02698176|EG002|Reported Event|MK-8628 20 mg TNBC Cohort-Part A|Participants in the TNBC cohort in Part A of the study received MK-8628 20 mg PO, BID, in a fasted state for 21 consecutive days per cycle. Participants received MK-8628 in continuous cycles up to 24 months.
11267913|NCT02698189|BG000|Baseline|MK-8628 20 mg AML Cohort|Participants in the AML cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267914|NCT02698189|BG001|Baseline|MK-8628 20 mg DLBCL Cohort|Participants in the DLBCL cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267915|NCT02698189|BG002|Baseline|Total|Total of all reporting groups
11267916|NCT02698189|FG000|Participant Flow|MK-8628 20 mg Acute Myeloid Leukemia (AML) Cohort|Participants in the AML cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267917|NCT02698189|FG001|Participant Flow|MK-8628 20 mg Diffuse Large B Cell Lymphoma (DLBCL) Cohort|Participants in the DLBCL cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267918|NCT02698189|OG000|Outcome|MK-8628 20 mg AML Cohort|Participants in the AML cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267919|NCT02698189|OG001|Outcome|MK-8628 20 mg DLBCL Cohort|Participants in the DLBCL cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267920|NCT02698189|OG000|Outcome|MK-8628 20 mg DLBCL Cohort|Participants in the DLBCL cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267921|NCT02698189|OG000|Outcome|MK-8628 20 mg AML+DLBCL Cohorts|Total number of participants from both cohorts (AML and DLBCL) received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267922|NCT02698189|EG000|Reported Event|MK-8628 20 mg AML Cohort|Participants in the AML cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267923|NCT02698189|EG001|Reported Event|MK-8628 20 mg DLBCL Cohort|Participants in the DLBCL cohort received 20 mg of MK-8628 as an oral capsule twice a day for 21 consecutive days per cycle (21-day cycle).
11267924|NCT02698215|BG000|Baseline|Varenicline Plus Naltrexone|"VAR (1 mg twice daily) + NTX (50 mg once daily)~Varenicline plus Naltrexone: Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily"
11267925|NCT02698215|BG001|Baseline|Varenicline|"VAR (1 mg twice daily)~Varenicline: Varenicline 1 mg twice daily"
11267926|NCT02698215|BG002|Baseline|Total|Total of all reporting groups
11267927|NCT02698215|FG000|Participant Flow|Varenicline Plus Naltrexone|"VAR (1 mg twice daily) + NTX (50 mg once daily)~Varenicline plus Naltrexone: Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily"
11267928|NCT02698215|FG001|Participant Flow|Varenicline|"VAR (1 mg twice daily)~Varenicline: Varenicline 1 mg twice daily"
11267929|NCT02698215|OG000|Outcome|Varenicline Plus Naltrexone|"VAR (1 mg twice daily) + NTX (50 mg once daily)~Varenicline plus Naltrexone: Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily"
11267930|NCT02698215|OG001|Outcome|Varenicline|"VAR (1 mg twice daily)~Varenicline: Varenicline 1 mg twice daily"
11267931|NCT02698215|EG000|Reported Event|Varenicline Plus Naltrexone|"VAR (1 mg twice daily) + NTX (50 mg once daily)~Varenicline plus Naltrexone: Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily"
11267932|NCT02698215|EG001|Reported Event|Varenicline|"VAR (1 mg twice daily)~Varenicline: Varenicline 1 mg twice daily"
11286797|NCT02892734|FG000|Participant Flow|Treatment (Nivolumab, Ipilimumab)|"Patients receive nivolumab 240mg IV over 30 minutes Q2W for the first 16 weeks then 480mg IV every 4 weeks thereafter. Patients will Ipilimumab 1mg/kg IV over 90 minutes Q6W in the absence of disease progression or unacceptable toxicity. 1 Cycle = 12 weeks. Scans every 12 weeks for disease assessment.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11286798|NCT02892734|OG000|Outcome|Treatment (Nivolumab, Ipilimumab)|"Patients receive nivolumab 240mg IV over 30 minutes Q2W for the first 16 weeks then 480mg IV every 4 weeks thereafter. Patients will Ipilimumab 1mg/kg IV over 90 minutes Q6W in the absence of disease progression or unacceptable toxicity. 1 Cycle = 12 weeks. Scans every 12 weeks for disease assessment.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11286799|NCT02892734|EG000|Reported Event|Treatment (Nivolumab, Ipilimumab)|"Patients receive nivolumab 240mg IV over 30 minutes Q2W for the first 16 weeks then 480mg IV every 4 weeks thereafter. Patients will Ipilimumab 1mg/kg IV over 90 minutes Q6W in the absence of disease progression or unacceptable toxicity. 1 Cycle = 12 weeks. Scans every 12 weeks for disease assessment.~Ipilimumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11286800|NCT02892760|BG000|Baseline|With C-brace|"C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.~C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking."
11286801|NCT02892760|FG000|Participant Flow|With C-brace|"C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.~C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking."
11286802|NCT02892760|OG000|Outcome|With C-brace|"C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.~C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking."
11286803|NCT02892760|EG000|Reported Event|With C-brace|"C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.~C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking."
11286804|NCT02893878|BG000|Baseline|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
11286805|NCT02893878|BG001|Baseline|Vaccinated_Non GSK Group|Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
11286806|NCT02893878|BG002|Baseline|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
11286807|NCT02893878|BG003|Baseline|Total|Total of all reporting groups
11286808|NCT02893878|FG000|Participant Flow|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
11286809|NCT02893878|FG001|Participant Flow|Vaccinated_Non GSK Group|Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
11286810|NCT02893878|FG002|Participant Flow|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
11286811|NCT02893878|OG000|Outcome|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
11286812|NCT02893878|OG000|Outcome|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline 's (GSK's) influenza vaccination (Fluarix Tetra ) in 10 volunteer practices.
11267933|NCT02698241|BG000|Baseline|Device Diagnostic & Diuretic and Chronic Medication Management|Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
11267934|NCT02698241|FG000|Participant Flow|Device Diagnostic & Diuretic and Chronic Medication Management|Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
11267935|NCT02698241|OG000|Outcome|Device Diagnostic & Diuretic and Chronic Medication Management|Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
11267936|NCT02698241|EG000|Reported Event|Device Diagnostic & Diuretic and Chronic Medication Management|Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
11267937|NCT02698371|BG000|Baseline|All Participants|Each participant is enrolled in several randomly allocated arms/groups (G1, G2, G3, G4, G5, G6) and received one to six NCCLs restorations in premolar/molar teeth.
11267938|NCT02698371|FG000|Participant Flow|All Participants|Each participant is enrolled in several randomly allocated arms/groups (G1, G2, G3, G4, G5, G6) and received one to six NCCLs restorations in Premolar/molar teeth.
11267939|NCT02698371|OG000|Outcome|FBDC-SE (G1; Control Group)|Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
11267940|NCT02698371|OG001|Outcome|FBDC-SE-EE (G2; Control Group)|FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
11267941|NCT02698371|OG002|Outcome|FBU-ER (G3)|FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267942|NCT02698371|OG003|Outcome|FBU-SE (G4)|FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
11267943|NCT02698371|OG004|Outcome|ADU-ER (G5)|Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267944|NCT02698371|OG005|Outcome|ADU-SE (G6)|ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267945|NCT02698371|OG003|Outcome|FBU-SE (G4)|FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267946|NCT02698371|OG001|Outcome|FBDC-SE-EE (G2; Control Group)|FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel, and light-cured.
11267947|NCT02698371|EG000|Reported Event|FBDC-SE (G1; Control Group)|Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
10970128|NCT00909064|FG000|Participant Flow|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
10970129|NCT00909064|OG000|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
10970130|NCT00909064|EG000|Reported Event|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
11267948|NCT02698371|EG001|Reported Event|FBDC-SE-EE (G2; Control Group)|FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
11267949|NCT02698371|EG002|Reported Event|FBU-ER (G3)|FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267950|NCT02698371|EG003|Reported Event|FBU-SE (G4)|FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267951|NCT02698371|EG004|Reported Event|ADU-ER (G5)|Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11267952|NCT02698371|EG005|Reported Event|ADU-SE (G6)|ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
11286813|NCT02893878|OG001|Outcome|Vaccinated_Non GSK Group|Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
11267953|NCT02698410|BG000|Baseline|Lanreotide ATG Plus Temozolomide|Lanreotide ATG 120 mg was administered by deep subcutaneous injection on Day 1 (baseline) and every 28 days for up to 52 weeks. Participants also received temozolomide 250 mg capsule orally once daily for 5 consecutive days every 28 days for up to 52 weeks. The dose of temozolomide could subsequently be reduced to 180 mg daily for 5 consecutive days every 28 days in case of bone marrow toxicity.
11267954|NCT02698410|FG000|Participant Flow|Lanreotide Autogel (ATG) Plus Temozolomide|Lanreotide ATG 120 milligrams (mg) was administered by deep subcutaneous injection on Day 1 (baseline) and every 28 days for up to 52 weeks. Participants also received temozolomide 250 mg capsule orally once daily for 5 consecutive days every 28 days for up to 52 weeks. The dose of temozolomide could subsequently be reduced to 180 mg daily for 5 consecutive days every 28 days in case of bone marrow toxicity.
11267955|NCT02698410|OG000|Outcome|Lanreotide ATG Plus Temozolomide|Lanreotide ATG 120 mg was administered by deep subcutaneous injection on Day 1 (baseline) and every 28 days for up to 52 weeks. Participants also received temozolomide 250 mg capsule orally once daily for 5 consecutive days every 28 days for up to 52 weeks. The dose of temozolomide could subsequently be reduced to 180 mg daily for 5 consecutive days every 28 days in case of bone marrow toxicity.
11267956|NCT02698410|EG000|Reported Event|Lanreotide ATG Plus Temozolomide|Lanreotide ATG 120 mg was administered by deep subcutaneous injection on Day 1 (baseline) and every 28 days for up to 52 weeks. Participants also received temozolomide 250 mg capsule orally once daily for 5 consecutive days every 28 days for up to 52 weeks. The dose of temozolomide could subsequently be reduced to 180 mg daily for 5 consecutive days every 28 days in case of bone marrow toxicity.
11267957|NCT02698423|BG000|Baseline|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing"
11267958|NCT02698423|BG001|Baseline|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test"
11267959|NCT02698423|BG002|Baseline|Total|Total of all reporting groups
11267960|NCT02698423|FG000|Participant Flow|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing."
11267961|NCT02698423|FG001|Participant Flow|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test."
11267962|NCT02698423|OG000|Outcome|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
11267963|NCT02698423|OG001|Outcome|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test.~N=331"
11267964|NCT02698423|OG000|Outcome|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing."
11267965|NCT02698423|OG001|Outcome|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test."
11267966|NCT02698423|EG000|Reported Event|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.~Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
11267967|NCT02698423|EG001|Reported Event|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.~Papanicolau test: Women will be invited to come in for a physician-performed Pap test.~N=331"
11267968|NCT02698436|BG000|Baseline|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
11267969|NCT02698436|BG001|Baseline|2.5% Benzoyl Peroxide Treatment|Applied BPO treatment once daily
11267970|NCT02698436|BG002|Baseline|Total|Total of all reporting groups
11267971|NCT02698436|FG000|Participant Flow|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
11267972|NCT02698436|FG001|Participant Flow|Benzoyl Peroxide 2.5%|Apply test product to face once in the morning and once at night.
11267973|NCT02698436|OG000|Outcome|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
11267974|NCT02698436|OG001|Outcome|2.5% Benzoyl Peroxide|Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
11267975|NCT02698436|EG000|Reported Event|Acne Mask|Light therapy mask applied to the face once in the evening for a duration of 10 minutes
11267976|NCT02698436|EG001|Reported Event|2.5% Benzoyl Peroxide Treatment|Applied BPO treatment once daily
11267977|NCT02698475|BG000|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264.
11286814|NCT02893878|OG002|Outcome|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
11286815|NCT02893878|OG002|Outcome|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices
11286816|NCT02893878|OG002|Outcome|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in10 volunteer practices.
11286817|NCT02893878|EG000|Reported Event|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
11267978|NCT02698475|FG000|Participant Flow|Ustekinumab Standard Dosage|Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264.
11267979|NCT02698475|OG000|Outcome|Ustekinumab Standard Dose (Main Study)|Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
11267980|NCT02698475|OG000|Outcome|Ustekinumab Standard Dosage (Main Study)|Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
11267981|NCT02698475|OG000|Outcome|Ustekinumab Standard Dosage (Long-Term Extension [LTE])|Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg.
11267982|NCT02698475|EG000|Reported Event|Ustekinumab Standard Dosage (Main Study)|Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56.
11267983|NCT02698475|EG001|Reported Event|Ustekinumab Standard Dosage (Long-Term Extension [LTE])|Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg.
11267984|NCT02698566|BG000|Baseline|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
11267985|NCT02698566|FG000|Participant Flow|Ranibizumab PFS - Patients|Healthcare professionals (HCPs) administered ITV injections of ranibizumab 0.5 milligrams (mg) delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
11267986|NCT02698566|FG001|Participant Flow|Ranibizumab PFS - HCPs|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
11267987|NCT02698566|OG000|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
11267988|NCT02698566|EG000|Reported Event|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
11267989|NCT02698735|BG000|Baseline|Gentamicin Versus Placebo|Split body skin Test Site study with each patient getting 0.1% topical gentamicin to a test site wound (Test Site #1) or placebo ointment to another like sized wound (Test Site #2) and each patient getting an intradermal injection of gentamicin in an intact skin site (Test Site #3) or an intradermal injection of placebo solution to another intact skin site (Test Site #4). So, there are a total of 4 Test Skin Sites in each patient.
11267990|NCT02698735|FG000|Participant Flow|Gentamicin Versus Placebo|Split body skin Test Site study with each patient getting 0.1% topical gentamicin to a test site wound (Test Site #1) or placebo ointment to another like sized wound (Test Site #2) and each patient getting an intradermal injection of gentamicin in an intact skin site (Test Site #3) or an intradermal injection of placebo solution to another intact skin site (Test Site #4). So, there are a total of 4 Test Skin Sites in each patient.
11267991|NCT02698735|OG000|Outcome|Topical Gentamicin Ointment|0.1% Gentamicin antibiotic in vehicle ointment
11267992|NCT02698735|OG001|Outcome|Topical Placebo Ointment|Placebo Control (Vehicle ointment alone)
11267993|NCT02698735|OG002|Outcome|Intradermal Gentamicin Injection|8 mg Gentamicin in Solution (200ul Intradermal Injection)
11267994|NCT02698735|OG003|Outcome|Intradermal Placebo Injection|200 ul Placebo Intradermal Injection
10970131|NCT00909090|BG000|Baseline|12 mg Lutein + Zeaxanthin|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
11267995|NCT02698735|EG000|Reported Event|Topical Gentamicin Ointment|0.1% Gentamicin antibiotic in vehicle ointment
10970132|NCT00909090|BG001|Baseline|Visually Identical Placebo|"visually identical placebo~Placebo: Visually identical placebo, taken once daily for one year"
10970133|NCT00909090|BG002|Baseline|Total|Total of all reporting groups
11267996|NCT02698735|EG001|Reported Event|Topical Placebo Ointment|Placebo Control (Vehicle ointment alone)
11267997|NCT02698735|EG002|Reported Event|Intradermal Gentamicin Injection|8 mg Gentamicin in Solution (200ul Intradermal Injection)
11267998|NCT02698735|EG003|Reported Event|Intradermal Placebo Injection|200 ul Placebo Intradermal Injection
10970134|NCT00909090|FG000|Participant Flow|Intervention|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
10970135|NCT00909090|FG001|Participant Flow|Placebo|"visually identical placebo~Placebo: Visually identical placebo, taken once daily for one year"
11267999|NCT02698787|BG000|Baseline|Group 1: FAST First, Then ACE Sound Processing Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11268000|NCT02698787|BG001|Baseline|Group 2: ACE First, Then FAST Sound Processing Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11268001|NCT02698787|BG002|Baseline|Total|Total of all reporting groups
11268002|NCT02698787|FG000|Participant Flow|Group 1: FAST First, Then ACE Sound Coding Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11268003|NCT02698787|FG001|Participant Flow|Group 2: ACE First, Then FAST Sound Processng Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11268004|NCT02698787|OG000|Outcome|Group 1: FAST First, Then ACE Sound Processing Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11286818|NCT02893878|EG001|Reported Event|Vaccinated_Non GSK Group|Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
11286819|NCT02893878|EG002|Reported Event|Vaccinated_Unknown Group|Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
10970136|NCT00909090|OG000|Outcome|Luten + Zeaxanthin|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
10970137|NCT00909090|OG001|Outcome|Placebo|"visually identical placebo~Placebo: Visually identical placebo, taken once daily for one year"
10970138|NCT00909090|OG000|Outcome|Intervention|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
11268005|NCT02698787|OG001|Outcome|Group 2: ACE First, Then FAST Sound Processing Strategy|"All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.~Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy~Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy"
11268006|NCT02698787|EG000|Reported Event|No Sound Coding Strategy|Healing period after surgery.
11268007|NCT02698787|EG001|Reported Event|FAST Sound Coding Strategy|Participants utilising the FAST Sound Coding Strategy. Group 1 utilises in first 3 months, Group 2 utilises in second 3 months.
11268008|NCT02698787|EG002|Reported Event|ACE Sound Coding Strategy|Participants utilising the ACE Sound Coding Strategy. Group 1 utilises in second 3 months, Group 2 utilises in first 3 months.
11268009|NCT02698800|BG000|Baseline|Blue Blocking (BB)/Clear|"Wearing of BB lenses.~Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.~Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime."
11268010|NCT02698800|FG000|Participant Flow|BB First (7 d), Then Clear (7 d), Separated by 4-wk Washout|"Wearing of BB first for 7 days, followed by Clear lenses for 7 days, separated by 4-week washout period~Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.~Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime"
11268011|NCT02698800|FG001|Participant Flow|Clear First (7 ), Then BB (7 d), Separated by 4-wk Washout|Wearing Clear lenses first for 7 days, followed by BB lenses for 7 days, separated by a 4-week washout period
11268012|NCT02698800|OG000|Outcome|Blue Blocking (BB)|"Wearing of BB lenses.~Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime."
11268013|NCT02698800|OG000|Outcome|Clear|"Wearing of clear lenses~Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime."
11268014|NCT02698800|EG000|Reported Event|Blue Blocking (BB)|"Wearing of BB lenses.~Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime."
11268015|NCT02698800|EG001|Reported Event|Clear|"Wearing of clear lenses~Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime."
10970139|NCT00909090|OG000|Outcome|12 mg Lutein + Zeaxanthin|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
10970140|NCT00909090|OG001|Outcome|Visually Identical Placebo|"visually identical placebo~Placebo: Visually identical placebo, taken once daily for one year"
10970141|NCT00909090|EG000|Reported Event|Intervention|"10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin~Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year"
10970142|NCT00909090|EG001|Reported Event|Placebo|"visually identical placebo~Placebo: Visually identical placebo, taken once daily for one year"
11268016|NCT02699099|BG000|Baseline|Coad Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268017|NCT02699099|BG001|Baseline|RTS,S Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268018|NCT02699099|BG002|Baseline|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268019|NCT02699099|BG003|Baseline|Total|Total of all reporting groups
11268020|NCT02699099|FG000|Participant Flow|Coad Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268021|NCT02699099|FG001|Participant Flow|RTS,S Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268022|NCT02699099|FG002|Participant Flow|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268023|NCT02699099|OG000|Outcome|Coad Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268024|NCT02699099|OG001|Outcome|RTS,S Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268025|NCT02699099|OG001|Outcome|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268026|NCT02699099|OG000|Outcome|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268027|NCT02699099|OG002|Outcome|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268028|NCT02699099|EG000|Reported Event|Coad Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268029|NCT02699099|EG001|Reported Event|RTS,S Group|Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
11268030|NCT02699099|EG002|Reported Event|Control Group|Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
11268031|NCT02699125|BG000|Baseline|Placebo|"Placebo column have 6 rows of baseline Primary Outcome Values: 24-h, Wake and Sleep Systolic and Diastolic Blood Pressure. Placebo column also have 1 row of baseline Secondary Outcome Value: Brachial Artery Flow Mediated Dilation."
11268032|NCT02699125|FG000|Participant Flow|Placebo, Then Guanfacine, Then Hydrochlorothiazide|Participants first received Placebo for 2 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks.
11268033|NCT02699125|FG001|Participant Flow|Placebo, Then Hydrochlorothiazide Then Guanfacine.|Participants first received Placebo for 2 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.
11268034|NCT02699125|OG000|Outcome|Placebo|Placebo for 2 weeks
11268035|NCT02699125|OG001|Outcome|Guanfacine|Guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.
11268036|NCT02699125|OG002|Outcome|Hydrochlorothyazide|Hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
11268037|NCT02699125|OG000|Outcome|Placebo|Placebo for 2 weeks.
11268038|NCT02699125|OG002|Outcome|Hydrochlorothiazide|Hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
11268039|NCT02699125|EG000|Reported Event|Placebo|Placebo for 2 weeks.
11268040|NCT02699125|EG001|Reported Event|Guanfacine|"Guanfacine 1mg for 2 weeks followed by guanfacine 2mg for 4 weeks.~Guanfacine: Guanfacine 1mg for 2 weeks followed by guanfacine 2mg for 4 weeks."
11268041|NCT02699125|EG002|Reported Event|Hydrochlorothiazide|"Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks.~Hydrochlorothiazide: Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks"
11268042|NCT02699450|BG000|Baseline|Arm A: 0.3 mg Ranibizumab|Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268043|NCT02699450|BG001|Baseline|Arm B: 1.5 mg Faricimab|Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268044|NCT02699450|BG002|Baseline|Arm C: 6 mg Faricimab|Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268045|NCT02699450|BG003|Baseline|Total|Total of all reporting groups
11268046|NCT02699450|FG000|Participant Flow|Arm A: 0.3 mg Ranibizumab|Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268047|NCT02699450|FG001|Participant Flow|Arm B: 1.5 mg Faricimab|Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268048|NCT02699450|FG002|Participant Flow|Arm C: 6 mg Faricimab|Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268049|NCT02699450|OG000|Outcome|Arm A: 0.3 mg Ranibizumab|Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268050|NCT02699450|OG001|Outcome|Arm B: 1.5 mg Faricimab|Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268051|NCT02699450|OG002|Outcome|Arm C: 6 mg Faricimab|Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268052|NCT02699450|OG001|Outcome|Arm C: 6 mg Faricimab|Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268053|NCT02699450|EG000|Reported Event|Arm A: 0.3 mg Ranibizumab|Participants received 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268054|NCT02699450|EG001|Reported Event|Arm B: 1.5 mg Faricimab|Participants received 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268055|NCT02699450|EG002|Reported Event|Arm C: 6 mg Faricimab|Participants received 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant met pre-specified criteria they received a single dose of 0.3 mg ranibizumab and exited the study.
11268056|NCT02699463|BG000|Baseline|Continous Positive Airway Pressure|"Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial~Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA"
11268057|NCT02699463|BG001|Baseline|Control Group|"Participants will receive standard care (Sleep hygiene counseling) during the study.~Control Group: Standard sleep hygiene counseling as per published guidelines"
11268058|NCT02699463|BG002|Baseline|Total|Total of all reporting groups
11268059|NCT02699463|FG000|Participant Flow|Continous Positive Airway Pressure|"Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial~Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA"
11268060|NCT02699463|FG001|Participant Flow|Control Group|"Participants will receive standard care (Sleep hygiene counseling) during the study.~Control Group: Standard sleep hygiene counseling as per published guidelines"
11268061|NCT02699463|OG000|Outcome|Continous Positive Airway Pressure|"Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial~Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA"
11268062|NCT02699463|OG001|Outcome|Control Group|"Participants will receive standard care (Sleep hygiene counseling) during the study.~Control Group: Standard sleep hygiene counseling as per published guidelines"
11268063|NCT02699463|EG000|Reported Event|Continous Positive Airway Pressure|"Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial~Continous Positive Airway Pressure: CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA"
11268064|NCT02699463|EG001|Reported Event|Control Group|"Participants will receive standard care (Sleep hygiene counseling) during the study.~Control Group: Standard sleep hygiene counseling as per published guidelines"
11268065|NCT02699593|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11268066|NCT02699593|FG000|Participant Flow|Senofilcon A(Test)/Senofilcon A(Control)|Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
11268067|NCT02699593|FG001|Participant Flow|Senofilcon A(Control)/Senofilcon A(Test)|Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
11268068|NCT02699593|OG000|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
11268069|NCT02699593|OG001|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
11268070|NCT02699593|EG000|Reported Event|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
11268071|NCT02699593|EG001|Reported Event|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
11268072|NCT02699632|BG000|Baseline|All Participants|"Women previously, currently, or planning to become pregnant. Data utilized is from completed questionnaires only, is uncorrected, and was collected from January through June 2016.~Mode of initial contact with potential participants was made on the Internet (email and Facebook posts). Participants were instructed of survey length in these Internet advertisements and study purpose and data storage information on the first page of our electronic survey.~No incentives were offered to participants, no protected health information was collected, and no measures were used for prevention of multiple entries from the same individual."
11268073|NCT02699632|FG000|Participant Flow|All Participants|"The survey was taken by 360 women previously, currently, or planning to become pregnant.~Although number of unique site visitors between January and June 2016 is indeterminable, we had a completion rate of 69% (the percentage of surveys completed out of the total number initiated, ie, number of page 2 completions and number of page 1 completions)."
11268074|NCT02699632|OG000|Outcome|All Participants|Respondents were asked what types of research they were willing to participate in during pregnancy
11268075|NCT02699632|OG000|Outcome|All Participants|Survey respondents were asked how they would prefer to learn about a research study
11268076|NCT02699632|OG000|Outcome|All Participants|Survey respondents were asked about their comfort and whether or not their physician needed to be involved.
11268077|NCT02699632|OG000|Outcome|All Participants|Survey respondents were asked about their concerns and what could be done to help minimize those concerns.
11268078|NCT02699632|EG000|Reported Event|All Participants|
11268079|NCT02699684|BG000|Baseline|Overall|Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized.
11268080|NCT02699684|FG000|Participant Flow|AOHG, Then AOA|Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
11268081|NCT02699684|FG001|Participant Flow|AOA, Then AOHG|Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
11268082|NCT02699684|OG000|Outcome|AOHG Contact Lenses|Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
11268083|NCT02699684|OG001|Outcome|AOA Contact Lenses|Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
11268084|NCT02699684|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11268085|NCT02699684|EG001|Reported Event|AOHG Contact Lenses|All subjects exposed to AOHG contact lenses
11268086|NCT02699684|EG002|Reported Event|AOA Contact Lenses|All subjects exposed to AOA contact lenses
11268087|NCT02699749|BG000|Baseline|Schedule A: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268088|NCT02699749|BG001|Baseline|Schedule A: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268089|NCT02699749|BG002|Baseline|Schedule A: TAK-931 50 mg|TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268090|NCT02699749|BG003|Baseline|Schedule A: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268091|NCT02699749|BG004|Baseline|Schedule B: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268092|NCT02699749|BG005|Baseline|Schedule B: TAK-931 80 mg|TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268093|NCT02699749|BG006|Baseline|Schedule B: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268094|NCT02699749|BG007|Baseline|Schedule B: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268095|NCT02699749|BG008|Baseline|Schedule D: TAK-931 20 mg|TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268096|NCT02699749|BG009|Baseline|Schedule D: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268097|NCT02699749|BG010|Baseline|Schedule D: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268098|NCT02699749|BG011|Baseline|Schedule E: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268099|NCT02699749|BG012|Baseline|Schedule E: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268100|NCT02699749|BG013|Baseline|Schedule E: TAK-931 150 mg|TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
10970143|NCT00909155|BG000|Baseline|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
11268101|NCT02699749|BG014|Baseline|Total|Total of all reporting groups
11268102|NCT02699749|FG000|Participant Flow|Schedule A: TAK-931 30 mg|TAK-931 30 milligram (mg), capsule, orally, once daily (QD) for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268103|NCT02699749|FG001|Participant Flow|Schedule A: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268104|NCT02699749|FG002|Participant Flow|Schedule A: TAK-931 50 mg|TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268105|NCT02699749|FG003|Participant Flow|Schedule A: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268106|NCT02699749|FG004|Participant Flow|Schedule B: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily or twice daily (BID) for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268107|NCT02699749|FG005|Participant Flow|Schedule B: TAK-931 80 mg|TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268108|NCT02699749|FG006|Participant Flow|Schedule B: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268109|NCT02699749|FG007|Participant Flow|Schedule B: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268110|NCT02699749|FG008|Participant Flow|Schedule D: TAK-931 20 mg|TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268111|NCT02699749|FG009|Participant Flow|Schedule D: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268112|NCT02699749|FG010|Participant Flow|Schedule D: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268113|NCT02699749|FG011|Participant Flow|Schedule E: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268114|NCT02699749|FG012|Participant Flow|Schedule E: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268115|NCT02699749|FG013|Participant Flow|Schedule E: TAK-931 150 mg|TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268116|NCT02699749|OG000|Outcome|Schedule A: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268117|NCT02699749|OG001|Outcome|Schedule A: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268118|NCT02699749|OG002|Outcome|Schedule A: TAK-931 50 mg|TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268119|NCT02699749|OG003|Outcome|Schedule A: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268120|NCT02699749|OG004|Outcome|Schedule B: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268121|NCT02699749|OG005|Outcome|Schedule B: TAK-931 80 mg|TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268122|NCT02699749|OG006|Outcome|Schedule B: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268123|NCT02699749|OG007|Outcome|Schedule B: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268124|NCT02699749|OG008|Outcome|Schedule D: TAK-931 20 mg|TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268125|NCT02699749|OG009|Outcome|Schedule D: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268126|NCT02699749|OG010|Outcome|Schedule D: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268127|NCT02699749|OG011|Outcome|Schedule E: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268128|NCT02699749|OG012|Outcome|Schedule E: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268129|NCT02699749|OG013|Outcome|Schedule E: TAK-931 150 mg|TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268130|NCT02699749|EG000|Reported Event|Schedule A: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268131|NCT02699749|EG001|Reported Event|Schedule A: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268132|NCT02699749|EG002|Reported Event|Schedule A: TAK-931 50 mg|TAK-931 50 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268133|NCT02699749|EG003|Reported Event|Schedule A: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily for 14 days in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268134|NCT02699749|EG004|Reported Event|Schedule B: TAK-931 60 mg|TAK-931 60 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268135|NCT02699749|EG005|Reported Event|Schedule B: TAK-931 80 mg|TAK-931 80 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
10970144|NCT00909155|BG001|Baseline|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
10970145|NCT00909155|BG002|Baseline|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
11268136|NCT02699749|EG006|Reported Event|Schedule B: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268137|NCT02699749|EG007|Reported Event|Schedule B: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily or twice daily for 7 days, followed by 7 days of rest and repeated (7 days on and 7 days off treatment) in each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268138|NCT02699749|EG008|Reported Event|Schedule D: TAK-931 20 mg|TAK-931 20 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268139|NCT02699749|EG009|Reported Event|Schedule D: TAK-931 30 mg|TAK-931 30 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268140|NCT02699749|EG010|Reported Event|Schedule D: TAK-931 40 mg|TAK-931 40 mg, capsule, orally, once daily in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268141|NCT02699749|EG011|Reported Event|Schedule E: TAK-931 100 mg|TAK-931 100 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268142|NCT02699749|EG012|Reported Event|Schedule E: TAK-931 120 mg|TAK-931 120 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268143|NCT02699749|EG013|Reported Event|Schedule E: TAK-931 150 mg|TAK-931 150 mg, capsule, orally, once daily on Days 1 and 2 followed by 5 days of rest and repeated weekly (2 days on and 5 days off treatment) in each 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or termination of the study by the sponsor.
11268144|NCT02699866|BG000|Baseline|BLT Implant Ø 2.9 mm|"The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.~BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading."
11268145|NCT02699866|FG000|Participant Flow|BLT Implant Ø 2.9 mm|"The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.~BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading."
10970146|NCT00909155|BG003|Baseline|Total|Total of all reporting groups
11268146|NCT02699866|OG000|Outcome|BLT Implant Ø 2.9 mm|"The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.~BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading."
11268147|NCT02699866|EG000|Reported Event|BLT Implant Ø 2.9 mm|"The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.~BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading."
11268148|NCT02699892|BG000|Baseline|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
11268149|NCT02699892|FG000|Participant Flow|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
11268150|NCT02699892|OG000|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
11268151|NCT02699892|EG000|Reported Event|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
11268152|NCT02699970|BG000|Baseline|Precision|"Intra-system: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists.~Inter-system: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans."
11268153|NCT02699970|FG000|Participant Flow|Precision|"Intra-system: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists.~Inter-system: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans."
11268154|NCT02699970|OG000|Outcome|Intra-system Sub-study|At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists.
11268155|NCT02699970|OG001|Outcome|Inter-system Sub-study|At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans.
11268156|NCT02699970|EG000|Reported Event|Precision|"Intra-system sub-study: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists.~Inter-system sub-study: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans."
11268157|NCT02699983|BG000|Baseline|Group I (SparkPeople Program)|"Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.~Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.~Behavioral Dietary Intervention: Use SparkPeople web-based program~Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268158|NCT02699983|BG001|Baseline|Group II (Wait List)|Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
11268159|NCT02699983|BG002|Baseline|Total|Total of all reporting groups
11268160|NCT02699983|FG000|Participant Flow|Group I (SparkPeople Program)|"Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.~Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.~Behavioral Dietary Intervention: Use SparkPeople web-based program~Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268161|NCT02699983|FG001|Participant Flow|Group II (Wait List)|"Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268162|NCT02699983|OG000|Outcome|Group I (SparkPeople Program)|"Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.~Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.~Behavioral Dietary Intervention: Use SparkPeople web-based program~Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268163|NCT02699983|OG001|Outcome|Group II (Wait List)|"Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.~Exercise Intervention: Use Fitbit monitor~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268164|NCT02699983|OG001|Outcome|Group II (Wait List)|"Participants receive a weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.~Exercise Intervention: Use Fitbit monitor~Activity Monitoring Device: Wear Fitbit activity monitoring device"
11268165|NCT02699983|OG001|Outcome|Group II (Wait List)|Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.
11268166|NCT02699983|OG000|Outcome|Group I (SparkPeople Program)|"Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.~Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.~All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements."
11268167|NCT02699983|OG001|Outcome|Group II (Wait List)|Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.
11268168|NCT02699983|EG000|Reported Event|Group I (SparkPeople Program)|"Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.~Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.~All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements."
11268169|NCT02699983|EG001|Reported Event|Group II (Wait List)|Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.
11268170|NCT02699996|BG000|Baseline|Group Intervention Participants|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268171|NCT02699996|BG001|Baseline|Group Intervention Mentors|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268172|NCT02699996|BG002|Baseline|Total|Total of all reporting groups
11268173|NCT02699996|FG000|Participant Flow|Group Intervention Participants|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268174|NCT02699996|FG001|Participant Flow|Group Intervention Mentors|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268175|NCT02699996|OG000|Outcome|Group Intervention Participants|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268176|NCT02699996|OG001|Outcome|Group Intervention Mentors|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
10970147|NCT00909155|FG000|Participant Flow|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
11268177|NCT02699996|OG000|Outcome|Group Intervention Mentors|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268178|NCT02699996|EG000|Reported Event|Group Intervention Participants|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268179|NCT02699996|EG001|Reported Event|Group Intervention Mentors|one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
11268180|NCT02700165|BG000|Baseline|CoolSculpting With CoolMini Applicator|ZELTIQ CoolSculpting System Treatment Group
11268181|NCT02700165|FG000|Participant Flow|CoolSculpting With CoolMini Applicator for Fat Reduction in the Chin|Per protocol, subjects were permitted to receive up to 3 CoolSculpting treatments on the submental and submandibular area at each of two treatment sessions spaced 6 weeks apart. At each treatment session, subjects were treated with the CoolSculpting device programmed for a specified protocol-defined time and temperature. All subjects received 2 cooling cycles at the first treatment session. At the second treatment visit, 12 subjects received 2 cooling cycles and 2 received 1 cycle.
11268182|NCT02700165|OG000|Outcome|CoolSculpting With CoolMini Applicator|ZELTIQ CoolSculpting System Treatment Group
11268183|NCT02700165|OG000|Outcome|CoolSculpting With CoolMini Applicator|The ZELTIQ CoolSculpting System Treatment Group
11268184|NCT02700165|EG000|Reported Event|CoolSculpting With CoolMini Applicator|The ZELTIQ CoolSculpting System Treatment Group
11268185|NCT02700334|BG000|Baseline|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11268186|NCT02700334|BG001|Baseline|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo: one per day before breakfast during 12 weeks."
11268187|NCT02700334|BG002|Baseline|Total|Total of all reporting groups
10970148|NCT00909155|FG001|Participant Flow|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
11268188|NCT02700334|FG000|Participant Flow|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11268189|NCT02700334|FG001|Participant Flow|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo: one per day before breakfast during 12 weeks."
11268190|NCT02700334|OG000|Outcome|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11268191|NCT02700334|OG001|Outcome|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo: one per day before breakfast during 12 weeks."
11268192|NCT02700334|EG000|Reported Event|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11268193|NCT02700334|EG001|Reported Event|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo: one per day before breakfast during 12 weeks."
11268194|NCT02700412|BG000|Baseline|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11268195|NCT02700412|FG000|Participant Flow|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11268196|NCT02700412|OG000|Outcome|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11268197|NCT02700412|EG000|Reported Event|Epidiolex|The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
11268198|NCT02700425|BG000|Baseline|His Bundle Pacing|"Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268199|NCT02700425|BG001|Baseline|Coronary Sinus Pacing|"Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268200|NCT02700425|BG002|Baseline|Total|Total of all reporting groups
11268201|NCT02700425|FG000|Participant Flow|His Bundle Pacing|"Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268202|NCT02700425|FG001|Participant Flow|Coronary Sinus Pacing|"Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268203|NCT02700425|OG000|Outcome|His Bundle Pacing|"Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268204|NCT02700425|OG001|Outcome|Coronary Sinus Pacing|"Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268205|NCT02700425|EG000|Reported Event|His Bundle Pacing|"Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268206|NCT02700425|EG001|Reported Event|Coronary Sinus Pacing|"Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.~CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture."
11268207|NCT02700815|BG000|Baseline|Placebo Gel|Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.
11268208|NCT02700815|BG001|Baseline|Capsaicin (0.075%) Gel|Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268209|NCT02700815|BG002|Baseline|Diclofenac (2%) Gel|Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.
11268210|NCT02700815|BG003|Baseline|Diclofenac (2%) +Capsaicin (0.075%) Gel|Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268211|NCT02700815|BG004|Baseline|Total|Total of all reporting groups
11268212|NCT02700815|FG000|Participant Flow|Placebo Gel|Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.
11268213|NCT02700815|FG001|Participant Flow|Capsaicin (0.075%) Gel|Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268214|NCT02700815|FG002|Participant Flow|Diclofenac (2%) Gel|Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.
11268215|NCT02700815|FG003|Participant Flow|Diclofenac (2%) +Capsaicin (0.075%) Gel|Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268216|NCT02700815|OG000|Outcome|Placebo Gel|Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.
11268217|NCT02700815|OG001|Outcome|Capsaicin (0.075%) Gel|Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268218|NCT02700815|OG002|Outcome|Diclofenac (2%) Gel|Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.
11268219|NCT02700815|OG003|Outcome|Diclofenac (2%) +Capsaicin (0.075%) Gel|Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268220|NCT02700815|EG000|Reported Event|Placebo Gel|Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.
11268221|NCT02700815|EG001|Reported Event|Capsaicin (0.075%) Gel|Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268222|NCT02700815|EG002|Reported Event|Diclofenac (2%) Gel|Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.
11268223|NCT02700815|EG003|Reported Event|Diclofenac (2%) +Capsaicin (0.075%) Gel|Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
11268224|NCT02700919|BG000|Baseline|BCT197 High Dose Regimen|Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268225|NCT02700919|BG001|Baseline|BCT197 Low Dose Regimen|Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268226|NCT02700919|BG002|Baseline|Placebo|Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
10970149|NCT00909155|FG002|Participant Flow|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
11268227|NCT02700919|BG003|Baseline|Total|Total of all reporting groups
11268228|NCT02700919|FG000|Participant Flow|BCT197 High Dose Regimen|Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268229|NCT02700919|FG001|Participant Flow|BCT197 Low Dose Regimen|Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268230|NCT02700919|FG002|Participant Flow|Placebo|Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268231|NCT02700919|OG000|Outcome|BCT197 High Dose Regimen|Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268232|NCT02700919|OG001|Outcome|BCT197 Low Dose Regimen|Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268233|NCT02700919|OG002|Outcome|Placebo|Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268234|NCT02700919|EG000|Reported Event|BCT197 High Dose Regimen|Participants received 75 mg BCT197 orally on Day 1. Subsequent doses with 40 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268235|NCT02700919|EG001|Reported Event|BCT197 Low Dose Regimen|Participants received 40 mg BCT197 orally on Day 1. Subsequent doses with 20 mg BCT197 were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268236|NCT02700919|EG002|Reported Event|Placebo|Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally on Day 3 and Day 5, respectively. All participants also received standard of care treatment for the acute exacerbation.
11268237|NCT02700984|BG000|Baseline|Cataract Surgery + CyPass|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268238|NCT02700984|BG001|Baseline|Cataract Surgery Only|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268239|NCT02700984|BG002|Baseline|Total|Total of all reporting groups
11268240|NCT02700984|FG000|Participant Flow|Cataract Surgery + CyPass|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268241|NCT02700984|FG001|Participant Flow|Cataract Surgery Only|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268242|NCT02700984|OG000|Outcome|Cataract Surgery + CyPass|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268243|NCT02700984|OG001|Outcome|Cataract Surgery Only|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268244|NCT02700984|OG000|Outcome|CyPass Visible|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) and visible by gonioscopy
11268245|NCT02700984|OG001|Outcome|Cypass Not Visible|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial) and not visible by gonioscopy
11268246|NCT02700984|OG000|Outcome|Cataract Surgery + CyPass, Month 36|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268247|NCT02700984|OG001|Outcome|Cataract Surgery + CyPass, Month 48|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268248|NCT02700984|OG002|Outcome|Cataract Surgery + CyPass, Month 60|CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
11268249|NCT02700984|OG003|Outcome|Cataract Surgery Only, Month 36|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268250|NCT02700984|OG004|Outcome|Cataract Surgery Only, Month 48|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268251|NCT02700984|OG005|Outcome|Cataract Surgery Only, Month 60|Cataract surgery (COMPASS trial) with no CyPass Micro-Stent implantation
11268252|NCT02700984|EG000|Reported Event|CyPass Micro-Stent + Cataract Surgery (Study Eye)|All eyes implanted with CyPass Micro-Stent at the conclusion of cataract surgery. At risk population is reported in units of eye.
11268253|NCT02700984|EG001|Reported Event|Cataract Surgery Only (Study Eye)|All eyes wherein cataract surgery occurred. At risk population is reported in units of eye
11268254|NCT02700984|EG002|Reported Event|CyPass Micro-Stent + Cataract Surgery (Systemic)|All subjects implanted with CyPass Micro-Stent at the conclusion of cataract surgery (non-study eye or not eye-related).
11268255|NCT02700984|EG003|Reported Event|Cataract Surgery Only (Systemic)|All subjects who underwent cataract surgery (non-study eye or not eye-related).
11268256|NCT02700997|BG000|Baseline|Vascular Clip|"Application of a clip to dissolvable sutures.~Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging"
11268257|NCT02700997|FG000|Participant Flow|Vascular Clip|"Application of a clip to dissolvable sutures.~Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging"
11268258|NCT02700997|OG000|Outcome|Vascular Clip|"Application of a clip to dissolvable sutures.~Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging"
11268259|NCT02700997|EG000|Reported Event|Vascular Clip|"Application of a clip to dissolvable sutures.~Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging"
11268260|NCT02701049|BG000|Baseline|Mode 0|Patients who were not asked their SO/GI
11268261|NCT02701049|BG001|Baseline|Mode 1|Patients who were verbally asked by a nurse their SO/GI
11268262|NCT02701049|BG002|Baseline|Mode 2|Patients whose SO/GI was collected non-verbally on a form
11268263|NCT02701049|BG003|Baseline|Total|Total of all reporting groups
11268264|NCT02701049|FG000|Participant Flow|Mode 0|Patients who were not asked their SO/GI
11268265|NCT02701049|FG001|Participant Flow|Mode 1|Patients who were verbally asked by a nurse their SO/GI
11268266|NCT02701049|FG002|Participant Flow|Mode 2|Patients whose SO/GI was collected non-verbally on a form
11268267|NCT02701049|OG000|Outcome|Mode 0|Patients who were not asked their SO/GI
11268268|NCT02701049|OG001|Outcome|Mode 1|Patients who were verbally asked by a nurse their SO/GI
11268269|NCT02701049|OG002|Outcome|Mode 2|Patients whose SO/GI was collected non-verbally on a form
11268270|NCT02701049|OG000|Outcome|Mode 1|Nurses who verbally collected SO/GI
11268271|NCT02701049|OG001|Outcome|Mode 2|Registrars who collected SO/GI non-verbally on a form
11268272|NCT02701049|OG000|Outcome|Mode 1|Patients who had SO/GI recorded in the EHR of all adult ED patients
11268273|NCT02701049|OG001|Outcome|Mode 2|Patients who had SO/GI recorded in the EHR of all adult ED patients
11268274|NCT02701049|EG000|Reported Event|Mode 0|Patients who were not asked their SO/GI
11268275|NCT02701049|EG001|Reported Event|Mode 1|Patients who were verbally asked by a nurse their SO/GI
11268276|NCT02701049|EG002|Reported Event|Mode 2|Patients whose SO/GI was collected non-verbally on a form
11268277|NCT02701062|BG000|Baseline|AtriClip®|"LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.~AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems"
11268278|NCT02701062|BG001|Baseline|No AtriClip®|"Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.~Other Names:~Warfarin/Coumadin~New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban~No AtriClip® used."
11268279|NCT02701062|BG002|Baseline|Total|Total of all reporting groups
11268280|NCT02701062|FG000|Participant Flow|AtriClip®|"LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.~AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems"
11268281|NCT02701062|FG001|Participant Flow|No AtriClip®|"Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.~Other Names:~Warfarin/Coumadin~New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban~No AtriClip® used."
11268282|NCT02701062|OG000|Outcome|AtriClip®|"LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.~AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems"
11268283|NCT02701062|OG000|Outcome|AtriClip With OAC|Patients in the AtriClip group that were administered an Oral Anticoagulant (OAC) at any time following the procedure
11268284|NCT02701062|OG001|Outcome|AtriClip Without OAC|Patients in the AtriClip group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
11268285|NCT02701062|OG002|Outcome|Standard of Care With OAC|Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure
11268286|NCT02701062|OG003|Outcome|Standard of Care Without OAC|Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
11268287|NCT02701062|OG004|Outcome|Combined Standard of Care|Combined Standard of Care group with or without OAC
11268288|NCT02701062|OG002|Outcome|Combined AtriClip|Combined AtriClip group with or without OAC
11268289|NCT02701062|OG003|Outcome|Standard of Care With OAC|Patients in the No AtriClip (Standard of Care) group that were administered an Oral Anticoagulant (OAC) at any time following the procedure
11268290|NCT02701062|OG004|Outcome|Standard of Care Without OAC|Patients in the No AtriClip (Standard of Care) group that were not administered an Oral Anticoagulant (OAC) at any time following the procedure
11268291|NCT02701062|OG005|Outcome|Combined Standard of Care|Combined Standard of Care group with or without OAC
11268292|NCT02701062|EG000|Reported Event|AtriClip®|"LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.~AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems"
11268293|NCT02701062|EG001|Reported Event|No AtriClip®|"Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.~Other Names:~Warfarin/Coumadin~New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban~No AtriClip® used."
11268294|NCT02701101|BG000|Baseline|Daily Skin Assessments (SoC and SEM Scanner Readings)|"The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:~Risk Assessment (standard of care; Braden, Waterlow, or Norton)~Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)~SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa~Use of SEM200 Scanner daily: From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels~Assessment and treatment o"
11268295|NCT02701101|FG000|Participant Flow|Daily Skin Assessments (Standard of Care and SEM Readings)|"The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:~Risk Assessment (standard of care; Braden, Waterlow, or Norton)~Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)~SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa.~Use of SEM200 Scanner daily: From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels"
11337555|NCT03587207|EG001|Reported Event|rMenBOMV+ACWY_S Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).
11268296|NCT02701101|OG000|Outcome|Daily Skin Assessments (SoC and SEM Scanner Readings)|"The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:~Risk Assessment (standard of care; Braden, Waterlow, or Norton)~Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)~SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa."
11268297|NCT02701101|OG000|Outcome|Daily Skin Assessments (Standard of Care and SEM Readings)|"The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:~Risk Assessment (standard of care; Braden, Waterlow, or Norton)~Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)~SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa.~Use of SEM200 Scanner daily: From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels"
11268298|NCT02701101|EG000|Reported Event|Daily Skin Assessments (Standard of Care and SEM Readings)|"The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:~Risk Assessment (standard of care; Braden, Waterlow, or Norton)~Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)~SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa.~Use of SEM200 Scanner daily: From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels"
11268299|NCT02701257|BG000|Baseline|iPhone Bionic Pancreas - Lilly Glucagon|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed dailyy"
11268300|NCT02701257|BG001|Baseline|iLet Bionic Pancreas - Lilly Glucagon|"iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily"
11268301|NCT02701257|BG002|Baseline|iLet Bionic Pancreas - Xerisol Glucagon|"iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump"
11268302|NCT02701257|BG003|Baseline|iLet Infusion Set First, Then Contact Detach|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.~Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268303|NCT02701257|BG004|Baseline|Contact Detach First, Then iLet Infusion Set|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.~iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268304|NCT02701257|BG005|Baseline|Total|Total of all reporting groups
11268305|NCT02701257|FG000|Participant Flow|iPhone BP First, Then iLet BP (Lilly gLucagon)|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily~iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device."
11337556|NCT03587207|EG002|Reported Event|rMenBOMV+ACWY_D Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).
11214056|NCT02290184|FG001|Participant Flow|Active Wait-list Control Group - Start With Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214057|NCT02290184|OG000|Outcome|Intervention / PilAm Go4Health Program|"In the first 3 months the Intervention group starts with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months the Intervention group transitions to a 3-month maintenance phase and continues physical activity and healthy eating behaviors learned in the PilAm Go4Health lifestyle intervention and then complete the study at the end of 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214058|NCT02290184|OG001|Outcome|Active Control - Pedometer Only|"This group start the first 3-months with a pedometer only. After 3 months, this Active Control transitions to receive the PilAm Go4Health lifestyle intervention for the second 3 month and completes the study at the end of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214059|NCT02290184|OG000|Outcome|Intervention Group - Start With PilAm Go4Health Intervention|"In the first 3 months intervention group start PilAm Go4Health lifestyle intervention. After initial 3-months participants will transition to a 3-month maintenance phase to maintain weight loss and learned lifestyle behaviors on their own. Group will complete the study at 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention promoting weight loss through physical activity and health diet using a mobile health app, pedometer to track daily step-counts, and social networking (in-person and Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on oral meds. Subjects will be asked: 1) log daily calorie/food intake and weekly wt. in mobile app diary and 2) wear a pedometer for 10hrs/day to monitor steps"
11214060|NCT02290184|OG001|Outcome|Active Wait-list Control Group - Start With Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214061|NCT02290184|OG000|Outcome|Intervention - PilAm Go4Health Program|"Baseline to 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor physical activity"
11214062|NCT02290184|OG001|Outcome|Active Control - Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11215714|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
11214063|NCT02290184|OG000|Outcome|Start With PilAm Go4Health Program|"Baseline to 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. At 3 months this group will begin a 3-month maintenance and will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214064|NCT02290184|OG001|Outcome|Start With Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214065|NCT02290184|EG000|Reported Event|Intervention - PilAm Go4Health Program|"Baseline to 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. The intervention group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity"
11214066|NCT02290184|EG001|Reported Event|Active Control - Pedometer Only|"In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months~PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts)."
11214067|NCT02290223|BG000|Baseline|Patient Activation Group Intervention|"The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.~Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week."
11214068|NCT02290223|BG001|Baseline|Usual Care|Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
11214069|NCT02290223|BG002|Baseline|Total|Total of all reporting groups
11214070|NCT02290223|FG000|Participant Flow|Patient Activation Group Intervention|"The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.~Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week."
11214071|NCT02290223|FG001|Participant Flow|Usual Care|Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
11214072|NCT02290223|OG000|Outcome|Patient Activation Group Intervention|"The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.~Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week."
11214073|NCT02290223|OG001|Outcome|Usual Care|Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
11214074|NCT02290223|EG000|Reported Event|Patient Activation Group Intervention|"The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.~Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week."
11214075|NCT02290223|EG001|Reported Event|Usual Care|Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
11214076|NCT02290340|BG000|Baseline|Placebo|Participants received placebo intramuscularly.
11214077|NCT02290340|BG001|Baseline|MEDI8897 10 mg|Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
11214078|NCT02290340|BG002|Baseline|MEDI8897 25 mg|Participants received a single dose of MEDI8897 25 mg intramuscularly.
11214079|NCT02290340|BG003|Baseline|MEDI8897 50 mg|Participants received a single dose of MEDI8897 50 mg intramuscularly.
11214080|NCT02290340|BG004|Baseline|Total|Total of all reporting groups
11268306|NCT02701257|FG001|Participant Flow|iLet BP First, Then iPhone BP (Lilly Glucagon)|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily~iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device."
11268307|NCT02701257|FG002|Participant Flow|iLet Bionic Pancreas - Xerisol Glucagon|"iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump"
11268308|NCT02701257|FG003|Participant Flow|iLet Infusion Set First, Then Contact Detach|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.~Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268309|NCT02701257|FG004|Participant Flow|Contact Detach Infusion Set First, Then iLet Infusion Set|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.~iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268310|NCT02701257|OG000|Outcome|iPhone Bionic Pancreas - Lilly Glucagon|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily"
11268311|NCT02701257|OG001|Outcome|iLet Bionic Pancreas - Lilly Glucagon|"iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily"
11268312|NCT02701257|OG002|Outcome|iLet Bionic Pancreas - Xerisol Glucagon|"iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump"
11268313|NCT02701257|OG003|Outcome|iLet Infusion Set|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268314|NCT02701257|OG004|Outcome|Contact Detach Infusion Set|"The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits.~Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits."
11268315|NCT02701257|OG000|Outcome|iPhone BP First, Then iLet BP (Lilly gLucagon)|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily~iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device."
11268316|NCT02701257|OG001|Outcome|iLet BP First, Then iPhone BP (Lilly Glucagon)|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily~iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device."
11268317|NCT02701257|OG003|Outcome|iLet Infusion Set|iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
11268318|NCT02701257|OG004|Outcome|Contact Detach Infusion Set|Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
11214081|NCT02290340|FG000|Participant Flow|Placebo|Participants received placebo intramuscularly.
11214082|NCT02290340|FG001|Participant Flow|MEDI8897 10 mg|Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
11214083|NCT02290340|FG002|Participant Flow|MEDI8897 25 mg|Participants received a single dose of MEDI8897 25 mg intramuscularly.
11214084|NCT02290340|FG003|Participant Flow|MEDI8897 50 mg|Participants received a single dose of MEDI8897 50 mg intramuscularly.
11214085|NCT02290340|OG000|Outcome|Placebo|Participants received placebo intramuscularly.
11214086|NCT02290340|OG001|Outcome|MEDI8897 10 mg|Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
11214087|NCT02290340|OG002|Outcome|MEDI8897 25 mg|Participants received a single dose of MEDI8897 25 mg intramuscularly.
11214088|NCT02290340|OG003|Outcome|MEDI8897 50 mg|Participants received a single dose of MEDI8897 50 mg intramuscularly.
11214089|NCT02290340|OG000|Outcome|MEDI8897 10 mg|Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
11214090|NCT02290340|OG001|Outcome|MEDI8897 25 mg|Participants received a single dose of MEDI8897 25 mg intramuscularly.
11214091|NCT02290340|OG002|Outcome|MEDI8897 50 mg|Participants received a single dose of MEDI8897 50 mg intramuscularly.
11214092|NCT02290340|EG000|Reported Event|Placebo|Participants received placebo intramuscularly.
11214093|NCT02290340|EG001|Reported Event|MEDI8897 10 mg|Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
11214094|NCT02290340|EG002|Reported Event|MEDI8897 25 mg|Participants received a single dose of MEDI8897 25 mg intramuscularly.
11214095|NCT02290340|EG003|Reported Event|MEDI8897 50 mg|Participants received a single dose of MEDI8897 50 mg intramuscularly.
11214096|NCT02290405|BG000|Baseline|Primary Insomnia (PI)|"PI sufferers enrolled will meet Research Diagnostic Criteria for insomnia disorder, score > 14 on the Insomnia Severity Index, report insomnia for > 3 months, have sleep difficulties > 3 nights per week, score < 3 on the Epworth Sleepiness Scale (ESS), score > 40 on the Hyperarousal Scale10 and report an inability to nap in the daytime.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214097|NCT02290405|BG001|Baseline|Normal Sleepers (NS)|"The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale10, and deny a practice of routine daytime napping.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214098|NCT02290405|BG002|Baseline|Total|Total of all reporting groups
11214099|NCT02290405|FG000|Participant Flow|Primary Insomnia (PI)|"PI sufferers enrolled will meet Research Diagnostic Criteria for insomnia disorder, score > 14 on the Insomnia Severity Index, report insomnia for > 3 months, have sleep difficulties > 3 nights per week, score < 3 on the Epworth Sleepiness Scale (ESS), score > 40 on the Hyperarousal Scale10 and report an inability to nap in the daytime.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214100|NCT02290405|FG001|Participant Flow|Normal Sleepers (NS)|"The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale10, and deny a practice of routine daytime napping.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214101|NCT02290405|OG000|Outcome|Primary Insomnia (PI)|"PI sufferers enrolled will meet Research Diagnostic Criteria for insomnia disorder, score > 14 on the Insomnia Severity Index, report insomnia for > 3 months, have sleep difficulties > 3 nights per week, score < 3 on the Epworth Sleepiness Scale (ESS), score > 40 on the Hyperarousal Scale10 and report an inability to nap in the daytime.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11268319|NCT02701257|EG000|Reported Event|iPhone Bionic Pancreas - Lilly Glucagon|"iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily"
11268320|NCT02701257|EG001|Reported Event|iLet Bionic Pancreas - Lilly Glucagon|"iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily"
11268321|NCT02701257|EG002|Reported Event|iLet Bionic Pancreas - Xerisol Glucagon|"iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.~iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.~Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump"
11268322|NCT02701257|EG003|Reported Event|iLet Infusion Set|iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
11268323|NCT02701257|EG004|Reported Event|Contact Detach|Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
11268324|NCT02701270|BG000|Baseline|All Study Participants|All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
11268325|NCT02701270|FG000|Participant Flow|Polydextrose First, Then Dextrose, Fibre1 and Fibre 2|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2.
11268326|NCT02701270|FG001|Participant Flow|Dextrose First, Then Fibre1, Fibre 2 and Polydextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control.
11268327|NCT02701270|FG002|Participant Flow|Fibre1 First, Then Fibre 2, Polydextrose and Dextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control.
11268328|NCT02701270|FG003|Participant Flow|Fibre 2 First, Then Polydextrose, Dextrose and Fibre1|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
11268329|NCT02701270|OG000|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
11268330|NCT02701270|OG001|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
11268331|NCT02701270|OG002|Outcome|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
11268332|NCT02701270|OG003|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
11268333|NCT02701270|OG002|Outcome|Polydextrose|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
11268334|NCT02701270|EG000|Reported Event|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
11268335|NCT02701270|EG001|Reported Event|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
11268336|NCT02701270|EG002|Reported Event|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
11268337|NCT02701270|EG003|Reported Event|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
11268338|NCT02701296|BG000|Baseline|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
11268339|NCT02701296|BG001|Baseline|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
11268340|NCT02701296|BG002|Baseline|Total|Total of all reporting groups
11268341|NCT02701296|FG000|Participant Flow|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
11268342|NCT02701296|FG001|Participant Flow|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
11268343|NCT02701296|OG000|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
11268344|NCT02701296|OG001|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
11268345|NCT02701296|EG000|Reported Event|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
11268346|NCT02701296|EG001|Reported Event|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
11268347|NCT02701361|BG000|Baseline|Mobile Mindfulness|"Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.~mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request."
11268348|NCT02701361|BG001|Baseline|Standard Mindfulness|"Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.~standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks."
11268349|NCT02701361|BG002|Baseline|Education Group|"A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.~education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials."
11268350|NCT02701361|BG003|Baseline|Total|Total of all reporting groups
11268351|NCT02701361|FG000|Participant Flow|Mobile Mindfulness|"Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.~mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request."
11268352|NCT02701361|FG001|Participant Flow|Standard Mindfulness|"Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.~standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks."
11268353|NCT02701361|FG002|Participant Flow|Education Group|"A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.~education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials."
11268354|NCT02701361|OG000|Outcome|All Eligible Subjects Approached to Participate in the Study|All eligible subjects approached to participate in the study.
10970150|NCT00909155|OG000|Outcome|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
11268355|NCT02701361|OG000|Outcome|All Eligible Participants|All eligible participants.
11268356|NCT02701361|OG000|Outcome|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
11268357|NCT02701361|OG001|Outcome|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
11268358|NCT02701361|OG002|Outcome|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
11268359|NCT02701361|EG000|Reported Event|Mobile Mindfulness|Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.
11268360|NCT02701361|EG001|Reported Event|Standard Mindfulness|Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
11268361|NCT02701361|EG002|Reported Event|Education Group|A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
11268362|NCT02701387|BG000|Baseline|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
11268363|NCT02701387|FG000|Participant Flow|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
11268364|NCT02701387|OG000|Outcome|AnyRidge Implant|"Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth)."
11268365|NCT02701387|OG001|Outcome|EZ Plus Implant|"Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market."
11268366|NCT02701387|EG000|Reported Event|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
11268367|NCT02701400|BG000|Baseline|Arm I (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.~Durvalumab: Given IV~Tremelimumab: Given IV"
11268368|NCT02701400|BG001|Baseline|Arm II (RT, Tremelimumab, Durvalumab)|"Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.~Durvalumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Stereotactic Body Radiation Therapy: Undergo SBRT~Tremelimumab: Given IV"
11268369|NCT02701400|BG002|Baseline|Total|Total of all reporting groups
11268370|NCT02701400|FG000|Participant Flow|Arm I (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.~Durvalumab: Given IV~Tremelimumab: Given IV"
11268371|NCT02701400|FG001|Participant Flow|Arm II (RT, Tremelimumab, Durvalumab)|"Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.~Durvalumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Stereotactic Body Radiation Therapy: Undergo SBRT~Tremelimumab: Given IV"
11268372|NCT02701400|OG000|Outcome|Arm I (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.~Durvalumab: Given IV~Tremelimumab: Given IV"
11268373|NCT02701400|OG001|Outcome|Arm II (RT, Tremelimumab, Durvalumab)|"Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.~Durvalumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Stereotactic Body Radiation Therapy: Undergo SBRT~Tremelimumab: Given IV"
11268374|NCT02701400|OG000|Outcome|Pooled Analysis (Arms I and II)|"Durvalumab: Given IV~Tremelimumab: Given IV~Patients in Arm II undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I."
11268375|NCT02701400|EG000|Reported Event|Arm I (Tremelimumab, Durvalumab)|"Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.~Durvalumab: Given IV~Tremelimumab: Given IV"
11268376|NCT02701400|EG001|Reported Event|Arm II (RT, Tremelimumab, Durvalumab)|"Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.~Durvalumab: Given IV~Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy~Stereotactic Body Radiation Therapy: Undergo SBRT~Tremelimumab: Given IV"
11268377|NCT02701413|BG000|Baseline|ApexM Device|"The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.~ApexM (Stimulation) Device: Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268378|NCT02701413|BG001|Baseline|Sham Device|"The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.~Sham Device: A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268379|NCT02701413|BG002|Baseline|Total|Total of all reporting groups
11268380|NCT02701413|FG000|Participant Flow|ApexM Device|"The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.~ApexM (Stimulation) Device: Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268381|NCT02701413|FG001|Participant Flow|Sham Device|"The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.~Sham Device: A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11337557|NCT03587207|EG003|Reported Event|rMenBOMV Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).
11337558|NCT03587207|EG004|Reported Event|MenACWY Group|Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
11214102|NCT02290405|OG001|Outcome|Normal Sleepers (NS)|"The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale10, and deny a practice of routine daytime napping.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214103|NCT02290405|EG000|Reported Event|Primary Insomnia (PI)|"PI sufferers enrolled will meet Research Diagnostic Criteria for insomnia disorder, score > 14 on the Insomnia Severity Index, report insomnia for > 3 months, have sleep difficulties > 3 nights per week, score < 3 on the Epworth Sleepiness Scale (ESS), score > 40 on the Hyperarousal Scale10 and report an inability to nap in the daytime.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214104|NCT02290405|EG001|Reported Event|Normal Sleepers (NS)|"The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale10, and deny a practice of routine daytime napping.~Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists."
11214105|NCT02290444|BG000|Baseline|Cognitively Relapsing Patients|"For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.~Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient."
11214106|NCT02290444|BG001|Baseline|Stable Multiple Sclerosis Patients|Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
11214107|NCT02290444|BG002|Baseline|Total|Total of all reporting groups
11214108|NCT02290444|FG000|Participant Flow|Cognitively Relapsing Patients|"For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.~Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient."
11214109|NCT02290444|FG001|Participant Flow|Stable Multiple Sclerosis Patients|Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
11214110|NCT02290444|OG000|Outcome|Cognitively Relapsing Patients|"For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.~Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient."
11214111|NCT02290444|OG001|Outcome|Stable Multiple Sclerosis Patients|Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
11214112|NCT02290444|EG000|Reported Event|Cognitively Relapsing Patients|"For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.~Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient."
11214113|NCT02290444|EG001|Reported Event|Stable Multiple Sclerosis Patients|Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
11214114|NCT02290509|BG000|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
11214115|NCT02290509|BG001|Baseline|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
11268382|NCT02701413|OG000|Outcome|ApexM Device|"The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.~ApexM (Stimulation) Device: Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268383|NCT02701413|OG001|Outcome|Sham Device|"The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.~Sham Device: A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268384|NCT02701413|EG000|Reported Event|ApexM Device|"The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.~ApexM (Stimulation) Device: Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268385|NCT02701413|EG001|Reported Event|Sham Device|"The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.~Sham Device: A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks."
11268386|NCT02701582|BG000|Baseline|Goal DIrected Therapy|"Anesthesiologist will be able to see the dynamic indicators, and will be given a study algorithm to follow, based on the trending data, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Sensor: Care based on algorithm and device."
11268387|NCT02701582|BG001|Baseline|Control Group|"FloTrac will be connected to the monitor, the anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be asked to choose from the same drug and fluid options used in the GDT group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Algorithm Not Visible: Standard of Care"
11268388|NCT02701582|BG002|Baseline|Total|Total of all reporting groups
11268389|NCT02701582|FG000|Participant Flow|Goal Directed Therapy|"Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Sensor: Care based on algorithm and device."
11268390|NCT02701582|FG001|Participant Flow|Control Group|"FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Algorithm Not Visible: Standard of Care"
11268391|NCT02701582|OG000|Outcome|Goal Directed Therapy|FloTrac monitor visible, care based on algorithm and device.
11268392|NCT02701582|OG001|Outcome|Control Group|FloTrac monitor not visible, standard of care
11268393|NCT02701582|OG000|Outcome|Goal Directed Therapy|"Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Sensor: Care based on algorithm and device."
11337559|NCT03587428|BG000|Baseline|Overall|Includes participants that were given interventions: Zinc-A toothpaste or Zinc-B toothpaste or Mineral Water
11337560|NCT03587428|FG000|Participant Flow|B-C-A|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product B, then product C followed by product A, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11268394|NCT02701582|OG001|Outcome|Control Group|"FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis.~FloTrac Algorithm Not Visible: Standard of Care"
11268395|NCT02701582|EG000|Reported Event|FloTrac Sensor|FloTrac monitor visible, care based on algorithm and device.
11268396|NCT02701582|EG001|Reported Event|Control Group|FloTrac monitor not visible, standard of care
11268397|NCT02701634|BG000|Baseline|ENTO|ENTO 400 mg or 200 mg tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268398|NCT02701634|BG001|Baseline|Placebo|Placebo to match ENTO tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268399|NCT02701634|BG002|Baseline|Total|Total of all reporting groups
11268400|NCT02701634|FG000|Participant Flow|ENTO|Entospletinib (ENTO) 400 mg or 200 mg tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268401|NCT02701634|FG001|Participant Flow|Placebo|Placebo to match Entospletinib tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268402|NCT02701634|OG000|Outcome|ENTO|ENTO 400 mg or 200 mg tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268403|NCT02701634|OG001|Outcome|Placebo|Placebo to match entospletinib tablets for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268404|NCT02701634|OG001|Outcome|Placebo|Placebo to match entospletinib tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268405|NCT02701634|EG000|Reported Event|ENTO|ENTO 400 mg or 200 mg tablet twice daily for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268406|NCT02701634|EG001|Reported Event|Placebo|Placebo to match entospletinib tablets for 48 weeks in combination with systemic corticosteroids as first-line therapy
11268407|NCT02701647|BG000|Baseline|25-Hz rTMS|"Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.~Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. Positive verbal feedback"
11268408|NCT02701647|BG001|Baseline|1-Hz rTMS|"Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11268409|NCT02701647|BG002|Baseline|Sham rTMS|"Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11268410|NCT02701647|BG003|Baseline|Total|Total of all reporting groups
11268411|NCT02701647|FG000|Participant Flow|25-Hz rTMS|Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
11268412|NCT02701647|FG001|Participant Flow|1-Hz rTMS|"Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11337561|NCT03587428|FG001|Participant Flow|C-B-A|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product C, then product B followed by product A, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11337562|NCT03587428|FG002|Participant Flow|A-B-C|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product A, then product B followed by product C, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11268413|NCT02701647|FG002|Participant Flow|Sham rTMS|"Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11268414|NCT02701647|OG000|Outcome|25-Hz rTMS|Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
11268415|NCT02701647|OG001|Outcome|1-Hz rTMS|Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
11268416|NCT02701647|OG002|Outcome|Sham rTMS|Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
11268417|NCT02701647|OG000|Outcome|25Hz-TT|"Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.~Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.~Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes."
11268418|NCT02701647|OG001|Outcome|1Hz-TT|"Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training.~Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.~Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes."
11268419|NCT02701647|OG002|Outcome|Sham-TT|"Sham rTMS will be applied over the same site as for real rTMS discounnted coil. Anothe coil using the same stimulation parameters as per 25Hz-TT group will be placed posterior to the subject's neck produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.~Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.~Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes."
11268420|NCT02701647|OG000|Outcome|25-Hz rTMS|Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
11268421|NCT02701647|OG001|Outcome|1-Hz rTMS|"Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11268422|NCT02701647|OG002|Outcome|Sham rTMS|"Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.~Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed."
11268423|NCT02701647|EG000|Reported Event|25-Hz rTMS|Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
11268424|NCT02701647|EG001|Reported Event|1-Hz rTMS|Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
11268425|NCT02701647|EG002|Reported Event|Sham rTMS|Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
11268426|NCT02701764|BG000|Baseline|Pregabalin|"Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Pregabalin"
11268427|NCT02701764|BG001|Baseline|Placebo|"Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Placebo"
11268428|NCT02701764|BG002|Baseline|Total|Total of all reporting groups
11268429|NCT02701764|FG000|Participant Flow|Pregabalin|"Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Pregabalin"
11268430|NCT02701764|FG001|Participant Flow|Placebo|"Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Placebo"
11268431|NCT02701764|OG000|Outcome|Pregabalin|"Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Pregabalin"
11268432|NCT02701764|OG001|Outcome|Placebo|"Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Placebo"
11268433|NCT02701764|EG000|Reported Event|Pregabalin|"Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Pregabalin"
11268434|NCT02701764|EG001|Reported Event|Placebo|"Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.~Placebo"
11268435|NCT02701868|BG000|Baseline|Phase 1|Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.
11268436|NCT02701868|BG001|Baseline|Phase 2 Standard Instructions|Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the standard infant formula preparation instructions.
11268437|NCT02701868|BG002|Baseline|Phase 2 Modified Instructions|Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the modified infant formula preparation instructions. The modified instructions were developed as a result of the focus groups' conditions in Phase 1.
11268438|NCT02701868|BG003|Baseline|Total|Total of all reporting groups
11268439|NCT02701868|FG000|Participant Flow|Phase 1|Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Research Center Demonstration Kitchen over the course of approximately 3 months.
11268440|NCT02701868|FG001|Participant Flow|Phase 2 Standard Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.
11268441|NCT02701868|FG002|Participant Flow|Phase 2 Modified Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
11268442|NCT02701868|OG000|Outcome|Phase 1|Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.
11268443|NCT02701868|OG001|Outcome|Phase 2|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.
11268444|NCT02701868|OG001|Outcome|Phase 2 Standard Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.
11268445|NCT02701868|OG002|Outcome|Phase 2 Modified Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
11268446|NCT02701868|EG000|Reported Event|Phase 1|Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Research Center Demonstration Kitchen over the course of approximately 3 months.
11268447|NCT02701868|EG001|Reported Event|Phase 2 Standard Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.
11268448|NCT02701868|EG002|Reported Event|Phase 2 Modified Instructions|Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
11268449|NCT02701985|BG000|Baseline|Placebo|Matching-placebo capsules was administered orally, 2 times a day, for up to 12 weeks.
11268450|NCT02701985|BG001|Baseline|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
11268451|NCT02701985|BG002|Baseline|Total|Total of all reporting groups
11268452|NCT02701985|FG000|Participant Flow|Placebo|Matching-placebo capsules was administered orally, 2 times a day, for up to 12 weeks.
11268453|NCT02701985|FG001|Participant Flow|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
11268454|NCT02701985|OG000|Outcome|Placebo|Matching-placebo capsules was administered orally, 2 times a day, for up to 12 weeks.
11268455|NCT02701985|OG001|Outcome|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
11268456|NCT02701985|OG000|Outcome|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
11268457|NCT02701985|EG000|Reported Event|Placebo|Matching-placebo capsules was administered orally, 2 times a day, for up to 12 weeks.
11214116|NCT02290509|BG002|Baseline|Total|Total of all reporting groups
11214117|NCT02290509|FG000|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
11214118|NCT02290509|FG001|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
11214119|NCT02290509|OG000|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
11214120|NCT02290509|OG001|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
11214121|NCT02290509|EG000|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
11214122|NCT02290509|EG001|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
11214123|NCT02290574|BG000|Baseline|Thermo-radio-chemotherapy Arm|Hyperthermia with concurrent chemo-radiation therapy
11214124|NCT02290574|FG000|Participant Flow|Thermo-radio-chemotherapy Arm|Hyperthermia with concurrent chemo-radiation therapy
11214125|NCT02290574|OG000|Outcome|Thermo-radio-chemotherapy Arm|Hyperthermia with concurrent chemo-radiation therapy
11214126|NCT02290574|OG000|Outcome|Thermo-radio-chemotherapy Arm|Radiation: Hyperthermia with concurrent chemo-radiation therapy
11214127|NCT02290574|EG000|Reported Event|Thermo-radio-chemotherapy Arm|Hyperthermia with concurrent chemo-radiation therapy
11214128|NCT02290613|BG000|Baseline|Ambrisentan Verum|"Study medication will be ambrisentan 10 mg (starting with 5 mg in the beginning of the study and then up-titrated to 10 mg/die).~Ambrisentan: Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/die.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake."
11214129|NCT02290613|BG001|Baseline|Placebo|"Placebo tablet~Placebo: Placebo tablet (one to two tablets corresponding to one to two verum tablets)"
11214130|NCT02290613|BG002|Baseline|Total|Total of all reporting groups
11214131|NCT02290613|FG000|Participant Flow|Ambrisentan Verum|"Study medication will be ambrisentan 10 mg (starting with 5 mg in the beginning of the study and then up-titrated to 10 mg/die).~Ambrisentan: Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/die.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake."
11214132|NCT02290613|FG001|Participant Flow|Placebo|"Placebo tablet~Placebo: Placebo tablet (one to two tablets corresponding to one to two verum tablets)"
11214133|NCT02290613|OG000|Outcome|Ambrisentan Verum|"Study medication will be ambrisentan 10 mg (starting with 5 mg in the beginning of the study and then up-titrated to 10 mg/die).~Ambrisentan: Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/die.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake."
11214134|NCT02290613|OG001|Outcome|Placebo|"Placebo tablet~Placebo: Placebo tablet (one to two tablets corresponding to one to two verum tablets)"
11214135|NCT02290613|EG000|Reported Event|Ambrisentan Verum|"Study medication will be ambrisentan 10 mg (starting with 5 mg in the beginning of the study and then up-titrated to 10 mg/die).~Ambrisentan: Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/die.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake."
11214136|NCT02290613|EG001|Reported Event|Placebo|"Placebo tablet~Placebo: Placebo tablet (one to two tablets corresponding to one to two verum tablets)"
11214137|NCT02290691|BG000|Baseline|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11268458|NCT02701985|EG001|Reported Event|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.
11268459|NCT02702011|BG000|Baseline|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
11268460|NCT02702011|BG001|Baseline|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
11268461|NCT02702011|BG002|Baseline|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268462|NCT02702011|BG003|Baseline|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268463|NCT02702011|BG004|Baseline|Total|Total of all reporting groups
11268464|NCT02702011|FG000|Participant Flow|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
11268465|NCT02702011|FG001|Participant Flow|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
11268466|NCT02702011|FG002|Participant Flow|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268467|NCT02702011|FG003|Participant Flow|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268468|NCT02702011|OG000|Outcome|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
11268469|NCT02702011|OG001|Outcome|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
11268470|NCT02702011|OG002|Outcome|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268471|NCT02702011|OG003|Outcome|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268472|NCT02702011|EG000|Reported Event|Placebo|Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
11268473|NCT02702011|EG001|Reported Event|Empagliflozin 2.5 mg|Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
11268474|NCT02702011|EG002|Reported Event|Empagliflozin 10 mg|Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268475|NCT02702011|EG003|Reported Event|Empagliflozin 25 mg|Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
11268476|NCT02702193|BG000|Baseline|SET-R/Healthy Home|"SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.~SET-R/Healthy Home: SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks."
11268477|NCT02702193|BG001|Baseline|Treatment as Usual (TAU)|Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.
11268478|NCT02702193|BG002|Baseline|Total|Total of all reporting groups
11268479|NCT02702193|FG000|Participant Flow|SET-R/Healthy Home|"SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.~SET-R/Healthy Home: SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks."
11268480|NCT02702193|FG001|Participant Flow|Treatment As Usual (TAU)|Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.
11337563|NCT03587428|FG003|Participant Flow|C-A-B|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product C, then product A followed by product B, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11268481|NCT02702193|OG000|Outcome|SET-R/Healthy Home|"SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.~SET-R/Healthy Home: SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks."
11268482|NCT02702193|OG001|Outcome|Treatment As Usual (TAU)|Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.
11268483|NCT02702193|EG000|Reported Event|SET-R/Healthy Home|"SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.~SET-R/Healthy Home: SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks."
11268484|NCT02702193|EG001|Reported Event|Treatment As Usual (TAU)|Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.
11268485|NCT02702388|BG000|Baseline|Lenvatinib 24 mg|Participants received lenvatinib 24 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of two 10-mg capsules and one 4-mg capsule containing lenvatinib and one 4-mg placebo capsule.
11268486|NCT02702388|BG001|Baseline|Lenvatinib 18 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11268487|NCT02702388|BG002|Baseline|Total|Total of all reporting groups
11268488|NCT02702388|FG000|Participant Flow|Lenvatinib 24 mg|Participants received lenvatinib 24 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of two 10-mg capsules and one 4-mg capsule containing lenvatinib and one 4-mg placebo capsule.
11268489|NCT02702388|FG001|Participant Flow|Lenvatinib 18 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11268490|NCT02702388|OG000|Outcome|Lenvatinib 24 mg|Participants received lenvatinib 24 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of two 10-mg capsules and one 4-mg capsule containing lenvatinib and one 4-mg placebo capsule.
11268491|NCT02702388|OG001|Outcome|Lenvatinib 18 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11268492|NCT02702388|OG000|Outcome|Lenvatinib 24 mg|All participants received lenvatinib 24 mg, capsule orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554), E7080-G000-201 (NCT00784303) and this current study (E7080-G000-211).
11268493|NCT02702388|OG001|Outcome|Lenvatinib 18 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months) in this current study E7080-G000-211. To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11337564|NCT03587428|FG004|Participant Flow|B-A-C|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product B, then product A followed by product C, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11268494|NCT02702388|OG000|Outcome|Lenvatinib or Placebo - All Participants|All participants who received lenvatinib 24 mg or 18 mg or placebo, capsule, orally, once daily in a 28-day treatment cycles until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554) and this current study (E7080-G000-211).
11214138|NCT02290691|BG001|Baseline|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214139|NCT02290691|BG002|Baseline|Total|Total of all reporting groups
11214140|NCT02290691|FG000|Participant Flow|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214141|NCT02290691|FG001|Participant Flow|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214142|NCT02290691|OG000|Outcome|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214143|NCT02290691|OG001|Outcome|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214144|NCT02290691|EG000|Reported Event|Needle- Free|"Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214145|NCT02290691|EG001|Reported Event|Needle and Syringe|"Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.~Influenza Vaccine: Influenza Vaccine"
11214146|NCT02290821|BG000|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
11214147|NCT02290821|BG001|Baseline|Placebo|"Placebo~diclofenac sodium gel 1%"
11214148|NCT02290821|BG002|Baseline|Total|Total of all reporting groups
11214149|NCT02290821|FG000|Participant Flow|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
11214150|NCT02290821|FG001|Participant Flow|Placebo|"Placebo~diclofenac sodium gel 1%"
11214151|NCT02290821|OG000|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
11214152|NCT02290821|OG001|Outcome|Placebo|"Placebo~diclofenac sodium gel 1%"
11214153|NCT02290821|EG000|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
11214154|NCT02290821|EG001|Reported Event|Placebo|"Placebo~diclofenac sodium gel 1%"
11214155|NCT02290873|BG000|Baseline|Remimazolam|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11214156|NCT02290873|BG001|Baseline|Placebo|Double-blind Placebo iv arm: inactive control arm
11214157|NCT02290873|BG002|Baseline|Midazolam|"Open-label Midazolam iv arm: 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.~*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill"
11214158|NCT02290873|BG003|Baseline|Total|Total of all reporting groups
11214159|NCT02290873|FG000|Participant Flow|Remimazolam|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11214160|NCT02290873|FG001|Participant Flow|Placebo|Double-blind Placebo iv arm: as an inactive control
11214161|NCT02290873|FG002|Participant Flow|Midazolam|"Open-label Midazolam iv arm: 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.~*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill"
11214162|NCT02290873|OG000|Outcome|Remimazolam|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11214163|NCT02290873|OG001|Outcome|Placebo|Double-blind Placebo iv arm: as an inactive control arm
11214164|NCT02290873|OG002|Outcome|Midazolam|"Open-label Midazolam iv arm: 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.~*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill"
11214165|NCT02290873|OG001|Outcome|Placebo|Double-blind Placebo iv arm: as an inactive control
11214166|NCT02290873|EG000|Reported Event|Remimazolam|Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11214167|NCT02290873|EG001|Reported Event|Placebo|Double-blind Placebo iv arm: as an inactive control
11214168|NCT02290873|EG002|Reported Event|Midazolam|"Open-label Midazolam iv arm: 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.~*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill"
11214169|NCT02290925|BG000|Baseline|Placebo Biscuit First Then Kothala Himbutu Biscuit Group|first given placebo biscuit for three months and after wash out period of one month given Kothala Himbutu biscuit (extract of Salacia reticulata) for three moths
11214170|NCT02290925|BG001|Baseline|Kothala Himbutu First Then Placebo Biscuit Group|first given Kothala Himbutu biscuit (extract of Salacia reticulata) for three months and after wash out period of one month given placebo biscuit for three moths
11214171|NCT02290925|BG002|Baseline|Total|Total of all reporting groups
11214172|NCT02290925|FG000|Participant Flow|Placebo Biscuit First and Then Kothala Himbutu Biscuit|(Description of the placebo biscuit, and the Kothala Himbutu biscuit is described in the other arm)) An identical placebo biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate). Given as same as the Kothala Himbutu biscuit and manufactured by the same manufacturer.
11268495|NCT02702388|OG000|Outcome|Lenvatinib or Placebo - All Participants|All participants received lenvatinib 24 mg or 18 mg or placebo, capsule orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554) and this current study (E7080-G000-211).
11268496|NCT02702388|OG000|Outcome|Lenvatinib or Placebo - All Participants|All participants initially received lenvatinib 24 mg or 18 mg or placebo, capsule orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554) and this current study (E7080-G000-211).
11268497|NCT02702388|OG000|Outcome|Lenvatinib or Placebo - All Participants|All participants who received lenvatinib 24 mg or 18 mg or placebo, capsule, orally, once daily in a 28-day treatment cycles until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554), E7080-G000-201 (NCT00784303) and this current study (E7080-G000-211).
11268498|NCT02702388|OG000|Outcome|Lenvatinib or Placebo - All Participants|All participants received lenvatinib 24 mg or 18 mg or placebo, capsule orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first in studies E7080-G000-303 (NCT01321554), E7080-G000-201 (NCT00784303) and this current study (E7080-G000-211) with available pharmacokinetic data.
11268499|NCT02702388|OG001|Outcome|Lenvatinib 18 mg|Participants initially received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11268500|NCT02702388|OG000|Outcome|Lenvatinib 24 mg|Participants initially received lenvatinib 24 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of two 10-mg capsules and one 4-mg capsule containing lenvatinib and one 4-mg placebo capsule.
11268501|NCT02702388|EG000|Reported Event|Lenvatinib 24 mg|Participants received lenvatinib 24 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of two 10-mg capsules and one 4-mg capsule containing lenvatinib and one 4-mg placebo capsule.
11268502|NCT02702388|EG001|Reported Event|Lenvatinib 18 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first (up to 35 months). To maintain blinded treatment assignment, participants received a total of 4 capsules in the form of one 10-mg capsule and two 4-mg capsules containing lenvatinib and one 10-mg placebo capsule.
11268503|NCT02702401|BG000|Baseline|Pembrolizumab + Best Supportive Care|Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS best supportive care (BSC). Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
11268504|NCT02702401|BG001|Baseline|Placebo + Best Supportive Care|Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
11268505|NCT02702401|BG002|Baseline|Total|Total of all reporting groups
11268506|NCT02702401|FG000|Participant Flow|Pembrolizumab + Best Supportive Care|Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS best supportive care (BSC). Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
11268507|NCT02702401|FG001|Participant Flow|Placebo + Best Supportive Care|Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
11268508|NCT02702401|OG000|Outcome|Pembrolizumab + Best Supportive Care|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
11268509|NCT02702401|OG001|Outcome|Placebo + Best Supportive Care|Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
11268510|NCT02702401|EG000|Reported Event|Pembrolizumab + Best Supportive Care|Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
11268511|NCT02702401|EG001|Reported Event|Placebo + Best Supportive Care|Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment PLUS BSC.
11268512|NCT02702518|BG000|Baseline|rhDNase I|"rhDNase I 0.1% eye drops 4 times a day for 8 weeks~rhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks"
11268513|NCT02702518|BG001|Baseline|Vehicle|"Drug vehicle eye drops 4 times a day for 8 weeks~Vehicle: Drug vehicle 4 times a day for 8 weeks"
11268514|NCT02702518|BG002|Baseline|Total|Total of all reporting groups
11268515|NCT02702518|FG000|Participant Flow|rhDNase I|"rhDNase I 0.1% eye drops 4 times a day for 8 weeks~rhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks"
11268516|NCT02702518|FG001|Participant Flow|Vehicle|"Drug vehicle eye drops 4 times a day for 8 weeks~Vehicle: Drug vehicle 4 times a day for 8 weeks"
11268517|NCT02702518|OG000|Outcome|rhDNase I|"rhDNase I 0.1% eye drops 4 times a day for 8 weeks~rhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks"
11268518|NCT02702518|OG001|Outcome|Vehicle|"Drug vehicle eye drops 4 times a day for 8 weeks~Vehicle: Drug vehicle 4 times a day for 8 weeks"
11268519|NCT02702518|EG000|Reported Event|rhDNase I|"rhDNase I 0.1% eye drops 4 times a day for 8 weeks~rhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks"
11268520|NCT02702518|EG001|Reported Event|Vehicle|"Drug vehicle eye drops 4 times a day for 8 weeks~Vehicle: Drug vehicle 4 times a day for 8 weeks"
11268521|NCT02702609|BG000|Baseline|Moldable Beta-TCP Grafting System|"Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)~easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement."
11268522|NCT02702609|BG001|Baseline|Allograft|"Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug~FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement."
11268523|NCT02702609|BG002|Baseline|Total|Total of all reporting groups
11268524|NCT02702609|FG000|Participant Flow|Moldable Beta-TCP Grafting System|"Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)~easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement."
11268525|NCT02702609|FG001|Participant Flow|Allograft|"Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug~FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement."
11268526|NCT02702609|OG000|Outcome|Moldable Beta-TCP Grafting System|"Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)~easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement."
11268527|NCT02702609|OG001|Outcome|Allograft|"Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug~FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement."
11268528|NCT02702609|EG000|Reported Event|Moldable Beta-TCP Grafting System|"Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)~easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement."
11268529|NCT02702609|EG001|Reported Event|Allograft|"Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug~FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement."
11268530|NCT02702921|BG000|Baseline|Standard of Care|Facility's Current Instrumentation
11268531|NCT02702921|BG001|Baseline|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11268532|NCT02702921|BG002|Baseline|Total|Total of all reporting groups
11268533|NCT02702921|FG000|Participant Flow|Standard of Care|Facility's Current Instrumentation
11268534|NCT02702921|FG001|Participant Flow|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11268535|NCT02702921|OG000|Outcome|Standard of Care|Facility's Current Instrumentation
11268536|NCT02702921|OG001|Outcome|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11268537|NCT02702921|EG000|Reported Event|Standard of Care|Facility's Current Instrumentation
11268538|NCT02702921|EG001|Reported Event|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11268539|NCT02702999|BG000|Baseline|Routine Third Trimester Care|Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
11268540|NCT02702999|BG001|Baseline|Serial Third Trimester Ultrasound|Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
11268541|NCT02702999|BG002|Baseline|Total|Total of all reporting groups
11268542|NCT02702999|FG000|Participant Flow|Routine Third Trimester Care|Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
11268543|NCT02702999|FG001|Participant Flow|Serial Third Trimester Ultrasound|Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
11268544|NCT02702999|OG000|Outcome|Routine Third Trimester Care|Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
11268545|NCT02702999|OG001|Outcome|Serial Third Trimester Ultrasound|Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
11268546|NCT02702999|EG000|Reported Event|Routine Third Trimester Care|"Routine third trimester care with clinically-indicated ultrasound (control)~Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)"
11268547|NCT02702999|EG001|Reported Event|Serial Third Trimester Ultrasound|"Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).~Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks)."
11337565|NCT03587428|FG005|Participant Flow|A-C-B|In this arm, participants received toothpaste in the form of slurry. The flow of events were first product A, then product C followed by product B, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water.
11337566|NCT03587428|OG000|Outcome|Zinc-A Toothpaste|In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
10970151|NCT00909155|OG001|Outcome|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
11214173|NCT02290925|FG001|Participant Flow|Kothala Himbutu Biscuit First and Then Placebo Biscuit|A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day as a mid morning and a mid afternoon snack for 3 months. Dry bark of the Salacia reticulate plant (210kg) is boiled repeatedly with water and evaporated to 210 liters of extract containing 10.5kg of dried extract (Herbal drug to extract ratio 1:1). The 100g of biscuit mixture are blended with 1.042ml of the aqueous extract. The raw material was authenticated by thin layer chromatography finger print analysis by the Industrial Technology Institute, Colombo. The energy, carbohydrate and fiber content of the study and the placebo biscuits are identical. The KH biscuit contained 447.21kcal of energy, 10.42g of protein, 13.97g of fat (6.29g saturated), 69.95g of carbohydrates (less than 0.10g of sugar), 7.53g of dietary fiber and 979mg of sodium per 100g. Glycaemic index of the KH biscuit was 30 and the placebo biscuit was 56.
11214174|NCT02290925|OG000|Outcome|Placebo Biscuit First Then Kothala Himbutu Biscuit Group|first given placebo biscuit for three months and after wash out period of one month given Kothala Himbutu biscuit (extract of Salacia reticulata) for three moths.
11214175|NCT02290925|OG001|Outcome|Kothala Himbutu Biscuit First Then Placebo Biscuit Group|first given Kothala Himbutu biscuit (extract of Salacia reticulata) for three months and after wash out period of one month given placebo biscuit for three moths
11214176|NCT02290925|OG000|Outcome|Placebo Biscuit First Then Kothala Himbutu Biscuit Group|first given placebo biscuit for three months and after wash out period of one month given Kothala Himbutu biscuit (extract of Salacia reticulata) for three moths
11214177|NCT02290925|OG001|Outcome|Kothala Himbutu Biscuit First and the Placebo Biscuit Group|first given Kothala Himbutu biscuit (extract of Salacia reticulata) for three months and after wash out period of one month given placebo biscuit for three moths
11214178|NCT02290925|EG000|Reported Event|Placebo Biscuit Group|"Adverse events are reported per intervention (participants consuming placebo biscuits are presented here). Separate Arms/Groups reflect all participants who received each intervention during the study."
11214179|NCT02290925|EG001|Reported Event|Kothala Himbutu Biscuit Group|"Adverse events are reported per intervention (participants consuming Kothala Himbutu biscuits are presented here). Separate Arms/Groups reflect all participants who received each intervention during the study."
11214180|NCT02291016|BG000|Baseline|Formoterol Via DPI Then Formoterol Via Nebulizer|"Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214181|NCT02291016|BG001|Baseline|Formoterol Via Nebulizer Then Formoterol Via DPI|"Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214182|NCT02291016|BG002|Baseline|Total|Total of all reporting groups
11214183|NCT02291016|FG000|Participant Flow|Formoterol Via DPI Then Formoterol Via Nebulizer|"Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and then Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214184|NCT02291016|FG001|Participant Flow|Formoterol Via Nebulizer Then Formoterol Via DPI|"Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and then Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214185|NCT02291016|OG000|Outcome|Formoterol With Nebilizer and Placebo With DPI|"One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.~Randomization:~Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.~Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11337567|NCT03587428|OG001|Outcome|Zinc-B Toothpaste|In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
11268548|NCT02703259|BG000|Baseline|Gabapentin|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules~Gabapentin~Acetaminophen~Celecoxib"
11268549|NCT02703259|BG001|Baseline|Control|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules~Acetaminophen~Celecoxib"
11268550|NCT02703259|BG002|Baseline|Total|Total of all reporting groups
11268551|NCT02703259|FG000|Participant Flow|Gabapentin|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules~Gabapentin~Acetaminophen~Celecoxib"
11268552|NCT02703259|FG001|Participant Flow|Control|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules~Acetaminophen~Celecoxib"
11268553|NCT02703259|OG000|Outcome|Gabapentin|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules~Gabapentin~Acetaminophen~Celecoxib"
11268554|NCT02703259|OG001|Outcome|Control|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules~Acetaminophen~Celecoxib"
11268555|NCT02703259|EG000|Reported Event|Gabapentin|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules~Gabapentin~Acetaminophen~Celecoxib"
11268556|NCT02703259|EG001|Reported Event|Control|"As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:~Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules~Acetaminophen~Celecoxib"
11268557|NCT02703311|BG000|Baseline|Cardioband|Patients who were enrolled and had the Cardioband procedure attempted
11268558|NCT02703311|FG000|Participant Flow|Cardioband|Patients who were enrolled and had the Cardioband procedure attempted
11268559|NCT02703311|OG000|Outcome|Cardioband|Patients who were enrolled and had the Cardioband procedure attempted
11268560|NCT02703311|EG000|Reported Event|Cardioband|Patients who were enrolled and had the Cardioband procedure attempted
11268561|NCT02703324|BG000|Baseline|All Participants|Individualized doses of LY900014 (Test) or insulin lispro (Reference) delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals in four, three-day periods.
11268562|NCT02703324|FG000|Participant Flow|Sequence 1, TRTR|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous subcutaneous (SC) infusion with intermittent bolus doses immediately before meals for three days.
11268563|NCT02703324|FG001|Participant Flow|Sequence 2, RTRT|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
11268564|NCT02703324|FG002|Participant Flow|Sequence 3, TTRR|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
11268565|NCT02703324|FG003|Participant Flow|Sequence 4, RRTT|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
11268566|NCT02703324|FG004|Participant Flow|Sequence 5, TRRT|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
11268567|NCT02703324|FG005|Participant Flow|Sequence 6, RTTR|T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
11337568|NCT03587428|OG002|Outcome|Mineral Water|In this arm, participants received mineral water.
11268568|NCT02703324|OG000|Outcome|Insulin Lispro - Reference|Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
11268569|NCT02703324|OG001|Outcome|LY900014 - Test|Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
11268570|NCT02703324|OG000|Outcome|Insulin Lispro - Reference|Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
11268571|NCT02703324|OG001|Outcome|LY900014 - Test|Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
11268572|NCT02703324|EG000|Reported Event|Insulin Lispro - Reference|Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
11268573|NCT02703324|EG001|Reported Event|LY900014 - Test|Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
11268574|NCT02703324|EG002|Reported Event|Insulin Lispro - Open Label|Individualized doses of open label insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses between periods.
11268575|NCT02703337|BG000|Baseline|All Participants|Individualized doses of LY900014 (Test) or insulin lispro (Reference) administered once SC at various mealtime intervals in each of six periods (Part A) and immediately before meals for 14 days (Part B).
11268576|NCT02703337|FG000|Participant Flow|Part A Sequence 1, ABFCED|A = LY900014 Test (15 minutes [mins] before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268577|NCT02703337|FG001|Participant Flow|Part A Sequence 2, BCADFE|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268578|NCT02703337|FG002|Participant Flow|Part A Sequence 3, CDBEAF|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268579|NCT02703337|FG003|Participant Flow|Part A Sequence 4, DECFBA|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268580|NCT02703337|FG004|Participant Flow|Part A Sequence 5, EFDACB|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268581|NCT02703337|FG005|Participant Flow|Part A Sequence 6, FAEBDC|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268582|NCT02703337|FG006|Participant Flow|Part B LY900014 (Test)|Individualized doses of LY900014 Test administered SC immediately before meals for 14 days.
11268583|NCT02703337|FG007|Participant Flow|Part B Insulin Lispro (Reference)|Individualized doses of Insulin Lispro Reference administered SC immediately before meals for 14 days.
11268584|NCT02703337|OG000|Outcome|Insulin Lispro - Reference (Part A)|Individualized doses of insulin lispro (Reference) administered once SC in three of six periods.
11268585|NCT02703337|OG001|Outcome|LY900014 - Test (Part A)|Individualized doses of LY900014 (Test) administered once SC in three of six periods.
11268586|NCT02703337|OG000|Outcome|Insulin Lispro - Reference (Part B)|Individualized doses of insulin lispro (Reference) administered SC immediately before each meal for 14 days.
11268587|NCT02703337|OG001|Outcome|LY900014 - Test (Part B)|Individualized doses of LY900014 (Test) administered SC immediately before each meal for 14 days.
11268588|NCT02703337|OG000|Outcome|Insulin Lispro - Reference 0 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods.
11268589|NCT02703337|OG001|Outcome|LY900014 - Test 0 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods.
11268590|NCT02703337|EG000|Reported Event|Insulin Lispro - Reference -15 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC 15 minutes prior to meal in one of six periods.
11268591|NCT02703337|EG001|Reported Event|Insulin Lispro - Reference 0 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods.
11268592|NCT02703337|EG002|Reported Event|Insulin Lispro - Reference +15 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC 15 minutes after start of meal in one of six periods.
11268593|NCT02703337|EG003|Reported Event|LY900014 - Test -15 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC 15 minutes prior to meal in one of six periods.
11268594|NCT02703337|EG004|Reported Event|LY900014 - Test 0 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods.
11268595|NCT02703337|EG005|Reported Event|LY900014 - Test +15 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC 15 minutes after start of meal in one of six periods.
11268596|NCT02703337|EG006|Reported Event|Insulin Lispro Open Label - (Part A)|Individualized doses of insulin lispro administered SC between periods.
11268597|NCT02703337|EG007|Reported Event|Insulin Lispro - Reference (Part B)|Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days.
11268598|NCT02703337|EG008|Reported Event|LY900014 - Test (Part B)|Individualized doses of LY900014 (Test) administered SC immediately before meals for 14 days.
11268599|NCT02703337|EG009|Reported Event|Insulin Lispro Open Label - (Part B)|Individualized doses of insulin lispro administered SC immediately before meals.
11268600|NCT02703350|BG000|Baseline|All Participants|Individualized doses of LY900014 (Test) or insulin lispro (Reference) administered once SC at various mealtime intervals in each of six periods (Part A) and immediately before meals for 14 days (Part B).
11268601|NCT02703350|FG000|Participant Flow|Part A Sequence 1, ABFCED|A = LY900014 Test (15 minutes [mins] before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268602|NCT02703350|FG001|Participant Flow|Part A Sequence 2, BCADFE|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268603|NCT02703350|FG002|Participant Flow|Part A Sequence 3, CDBEAF|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268604|NCT02703350|FG003|Participant Flow|Part A Sequence 4, DECFBA|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268605|NCT02703350|FG004|Participant Flow|Part A Sequence 5, EFDACB|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268606|NCT02703350|FG005|Participant Flow|Part A Sequence 6, FAEBDC|A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal).
11268607|NCT02703350|FG006|Participant Flow|Part B LY900014 (Test)|Individualized doses of LY900014 Test administered SC immediately before meals for 14 days.
11268608|NCT02703350|FG007|Participant Flow|Part B Insulin Lispro (Reference)|Individualized doses of Insulin Lispro Reference administered SC immediately before meals for 14 days.
11268609|NCT02703350|OG000|Outcome|Insulin Lispro - Reference (Part A)|Individualized doses of insulin lispro (Reference) administered once SC in three of six periods.
11268610|NCT02703350|OG001|Outcome|LY900014 - Test (Part A)|Individualized doses of LY900014 (Test) administered once SC in three of six periods.
11268611|NCT02703350|OG000|Outcome|Insulin Lispro - Reference (Part B)|Individualized doses of insulin lispro (Reference) administered SC immediately before each meal for 14 days.
11268612|NCT02703350|OG001|Outcome|LY900014 - Test (Part B)|Individualized doses of LY900014 (Test) administered SC immediately before each meal for 14 days.
11268613|NCT02703350|OG000|Outcome|Insulin Lispro - Reference 0 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods.
11268614|NCT02703350|OG001|Outcome|LY900014 - Test 0 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods.
11268615|NCT02703350|EG000|Reported Event|Insulin Lispro - Reference -15 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC 15 minutes prior to meal in one of six periods.
11268616|NCT02703350|EG001|Reported Event|Insulin Lispro - Reference 0 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods.
11268617|NCT02703350|EG002|Reported Event|Insulin Lispro - Reference +15 Min (Part A)|Individualized doses of insulin lispro (Reference) administered once SC 15 minutes after start of meal in one of six periods.
11268618|NCT02703350|EG003|Reported Event|LY900014 - Test -15 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC 15 minutes prior to meal in one of six periods.
11268619|NCT02703350|EG004|Reported Event|LY900014 - Test 0 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods.
11268620|NCT02703350|EG005|Reported Event|LY900014 - Test +15 Min (Part A)|Individualized doses of LY900014 (Test) administered once SC 15 minutes after start of meal in one of six periods.
11268621|NCT02703350|EG006|Reported Event|Insulin Lispro Open Label - (Part A)|Individualized doses of insulin lispro administered SC between periods.
11268622|NCT02703350|EG007|Reported Event|Insulin Lispro - Reference (Part B)|Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days.
11268623|NCT02703350|EG008|Reported Event|LY900014 - Test (Part B)|Individualized doses of LY900014 (Test) administered SC immediately before meals for 14 days.
11268624|NCT02703350|EG009|Reported Event|Insulin Lispro Open Label - (Part B)|Individualized doses of insulin lispro administered SC immediately before meals.
11268625|NCT02703454|BG000|Baseline|FIRM-only|"Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).~FIRM-guided RF ablation"
11268626|NCT02703454|BG001|Baseline|Conventional|"Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.~Conventional RF ablation"
11268627|NCT02703454|BG002|Baseline|Total|Total of all reporting groups
11268628|NCT02703454|FG000|Participant Flow|FIRM-only|"Subjects in this arm will be treated with Focal Impulse and Rotor Modulation (FIRM)-guided conventional radio frequency (RF) ablation without pulmonary vein isolation (PVI).~FIRM-guided RF ablation"
11268629|NCT02703454|FG001|Participant Flow|Conventional|"Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.~Conventional RF ablation"
11268630|NCT02703454|OG000|Outcome|FIRM-only|"Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).~FIRM-guided RF ablation"
11268631|NCT02703454|OG001|Outcome|Conventional|"Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.~Conventional RF ablation"
11268632|NCT02703454|EG000|Reported Event|FIRM-only|"Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI).~FIRM-guided RF ablation"
11268633|NCT02703454|EG001|Reported Event|Conventional|"Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.~Conventional RF ablation"
11268634|NCT02703467|BG000|Baseline|Healthy|Healthy participants
11268635|NCT02703467|BG001|Baseline|Mild-moderate|Mild-moderate asthma patients
11268636|NCT02703467|BG002|Baseline|Severe|Severe asthma patients
11268637|NCT02703467|BG003|Baseline|Total|Total of all reporting groups
11268638|NCT02703467|FG000|Participant Flow|Healthy|Healthy participants
11268639|NCT02703467|FG001|Participant Flow|Mild-moderate|Mild-moderate asthma patients
11268640|NCT02703467|FG002|Participant Flow|Severe|Severe asthma patients
11268641|NCT02703467|OG000|Outcome|Healthy|Healthy participants
11268642|NCT02703467|OG001|Outcome|Mild-moderate|Mild-moderate asthma patients
11268643|NCT02703467|OG002|Outcome|Severe|Severe asthma patients
11268644|NCT02703467|OG000|Outcome|Healthy Subjects|Healthy participants
11268645|NCT02703467|OG001|Outcome|Mild-moderate Asthma|Participants with Mild-moderate asthma
11268646|NCT02703467|OG002|Outcome|Severe Asthma|Participant with Severe asthma
11268647|NCT02703467|OG002|Outcome|Severe Asthma|Participants with severe asthma
11268648|NCT02703467|EG000|Reported Event|Healthy|Healthy participants
11268649|NCT02703467|EG001|Reported Event|Mild-moderate|Mild-moderate asthma patients
11268650|NCT02703467|EG002|Reported Event|Severe|Severe asthma patients
11268651|NCT02703532|BG000|Baseline|CARE-CITE Education Program Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268652|NCT02703532|BG001|Baseline|Traditional Education Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268653|NCT02703532|BG002|Baseline|Stroke Survivors With CARE-CITE Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
11268654|NCT02703532|BG003|Baseline|Stroke Survivors With Traditional Education Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
11268655|NCT02703532|BG004|Baseline|Total|Total of all reporting groups
11268656|NCT02703532|FG000|Participant Flow|CARE-CITE Education Program Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received 10 sessions of constraint-induced movement therapy (CIMT).
11268657|NCT02703532|FG001|Participant Flow|Traditional Education Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received 10 sessions of constraint-induced movement therapy (CIMT).
11268658|NCT02703532|FG002|Participant Flow|Stroke Survivors With CARE-CITE Carepartners|Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
11268659|NCT02703532|FG003|Participant Flow|Stroke Survivors With Traditional Education Carepartners|Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
11268660|NCT02703532|OG000|Outcome|Stroke Survivors With CARE-CITE Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
11268661|NCT02703532|OG001|Outcome|Stroke Survivors With Traditional Education Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
11268662|NCT02703532|OG000|Outcome|CARE-CITE Education Program Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268663|NCT02703532|OG001|Outcome|Traditional Education Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268664|NCT02703532|EG000|Reported Event|CARE-CITE Education Program Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268665|NCT02703532|EG001|Reported Event|Traditional Education Carepartners|Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).
11268666|NCT02703532|EG002|Reported Event|Stroke Survivors With CARE-CITE Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
11268667|NCT02703532|EG003|Reported Event|Stroke Survivors With Traditional Education Carepartners|Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
11268668|NCT02703636|BG000|Baseline|Rivastigmine Patch|Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
11268669|NCT02703636|FG000|Participant Flow|Rivastigmine Patch|Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
11268670|NCT02703636|OG000|Outcome|Rivastigmine Patch|Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
11337569|NCT03587428|EG000|Reported Event|Zinc-A Toothpaste|In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
11268671|NCT02703636|EG000|Reported Event|Exelon/Rivastigmine Patch|Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
11268672|NCT02703779|BG000|Baseline|Stem Cell Collection Without In-vivo Purging With Bortezomib|"Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).~NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268673|NCT02703779|BG001|Baseline|Stem Cell Collection With In-vivo Purging With Bortezomib|"Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.~There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268674|NCT02703779|BG002|Baseline|Total|Total of all reporting groups
11268675|NCT02703779|FG000|Participant Flow|Stem Cell Collection Without In-vivo Purging With Bortezomib|"Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).~NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268676|NCT02703779|FG001|Participant Flow|Stem Cell Collection With In-vivo Purging With Bortezomib|"Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.~There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268677|NCT02703779|OG000|Outcome|Stem Cell Collection Without In-vivo Purging With Bortezomib|"Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).~NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268678|NCT02703779|OG001|Outcome|Stem Cell Collection With In-vivo Purging With Bortezomib|"Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.~There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268679|NCT02703779|EG000|Reported Event|Stem Cell Collection Without In-vivo Purging With Bortezomib|"Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).~NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268680|NCT02703779|EG001|Reported Event|Stem Cell Collection With In-vivo Purging With Bortezomib|"Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.~There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B~Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.~Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.~Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator."
11268681|NCT02703909|BG000|Baseline|Moderate NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268682|NCT02703909|BG001|Baseline|Moderate NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268683|NCT02703909|BG002|Baseline|Deep NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268684|NCT02703909|BG003|Baseline|Deep NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268685|NCT02703909|BG004|Baseline|Total|Total of all reporting groups
11268686|NCT02703909|FG000|Participant Flow|Moderate NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268687|NCT02703909|FG001|Participant Flow|Moderate NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268688|NCT02703909|FG002|Participant Flow|Deep NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268689|NCT02703909|FG003|Participant Flow|Deep NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268690|NCT02703909|OG000|Outcome|Moderate NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268691|NCT02703909|OG001|Outcome|Moderate NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268692|NCT02703909|OG002|Outcome|Deep NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11337570|NCT03587428|EG001|Reported Event|Zinc-B Toothpaste|In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
11337571|NCT03587428|EG002|Reported Event|Mineral Water|In this arm, participants received mineral water.
11214186|NCT02291016|OG001|Outcome|Formoterol With Dry Powder Inhaler|"Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.~Randomization:~Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.~Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214187|NCT02291016|OG001|Outcome|Formoterol With Dry Powder Inhaler and Placebo With Nebulizer|"Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.~Randomization:~Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.~Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214188|NCT02291016|EG000|Reported Event|Formoterol With Nebulizer|"One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.~Randomization:~Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.~Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214189|NCT02291016|EG001|Reported Event|Formoterol With Dry Powder Inhaler|"One dose of Formoterol 12 µg (solution form) via DPI at either visit 1 or visit 2 depending on group randomization, which is listed below.~Randomization:~Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.~Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.~Placebo: Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2."
11214190|NCT02291029|BG000|Baseline|Cohort 1 CFZ533|CFZ533 3 mg/kg s.c.
11214191|NCT02291029|BG001|Baseline|Cohort 1 Placebo|Placebo s.c./CFZ533 3 mg/kg s.c.
11214192|NCT02291029|BG002|Baseline|Cohort 2 CFZ533|CFZ533 10 mg/kg i.v.
11214193|NCT02291029|BG003|Baseline|Cohort 2 Placebo|Placebo i.v./CFZ533 10 mg/kg i.v.
11214194|NCT02291029|BG004|Baseline|Cohort 3 CFZ533 Arm 1|CFZ533 600 mg s.c./CFZ533 300 mg s.c.
11214195|NCT02291029|BG005|Baseline|Cohort 3 CFZ533 Arm 2|CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
11214196|NCT02291029|BG006|Baseline|Total|Total of all reporting groups
11214197|NCT02291029|FG000|Participant Flow|Cohort 1 CFZ533|CFZ533 3 mg/kg s.c.
11214198|NCT02291029|FG001|Participant Flow|Cohort 1 Placebo|Placebo s.c./CFZ533 3 mg/kg s.c.
11214199|NCT02291029|FG002|Participant Flow|Cohort 2 CFZ533|CFZ533 10 mg/kg i.v.
11214200|NCT02291029|FG003|Participant Flow|Cohort 2 Placebo|Placebo i.v./CFZ533 10 mg/kg i.v.
11214201|NCT02291029|FG004|Participant Flow|Cohort 3 CFZ533 Arm 1|CFZ533 600 mg s.c./CFZ533 300 mg s.c.
11214202|NCT02291029|FG005|Participant Flow|Cohort 3 CFZ533 Arm 2|CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
11214203|NCT02291029|OG000|Outcome|Cohort 1 CFZ533|CFZ533 3 mg/kg s.c.
11214204|NCT02291029|OG001|Outcome|Cohort 1 Placebo|Placebo s.c./CFZ533 3 mg/kg s.c.
11214205|NCT02291029|OG002|Outcome|Cohort 2 CFZ533|CFZ533 10 mg/kg i.v.
11214206|NCT02291029|OG003|Outcome|Cohort 2 Placebo|Placebo i.v./CFZ533 10 mg/kg i.v.
11214207|NCT02291029|OG004|Outcome|Cohort 3 CFZ533 Arm 1|CFZ533 600 mg s.c./CFZ533 300 mg s.c.
11214208|NCT02291029|OG005|Outcome|Cohort 3 CFZ533 Arm 2|CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
11214209|NCT02291029|EG000|Reported Event|Cohort 1 CFZ533|CFZ533 3 mg/kg s.c.
11214210|NCT02291029|EG001|Reported Event|Cohort 1 Placebo|Placebo s.c./CFZ533 3 mg/kg s.c.
11214211|NCT02291029|EG002|Reported Event|Cohort 2 CFZ533|CFZ533 10 mg/kg i.v.
11214212|NCT02291029|EG003|Reported Event|Cohort 2 Placebo|Placebo i.v./CFZ533 10 mg/kg i.v.
11214213|NCT02291029|EG004|Reported Event|Cohort 3 CFZ533 Arm 1|CFZ533 600 mg s.c./CFZ533 300 mg s.c.
11214214|NCT02291029|EG005|Reported Event|Cohort 3 CFZ533 Arm 2|CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
11214215|NCT02291133|BG000|Baseline|Electrochemotherapy Treatment|"Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation~Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.~The maximum duration of procedure is 90 minutes, after liver mobilization.~Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)"
11214216|NCT02291133|FG000|Participant Flow|Electrochemotherapy Treatment|"Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation~Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.~The maximum duration of procedure is 90 minutes, after liver mobilization.~Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)"
11214217|NCT02291133|OG000|Outcome|Electrochemotherapy Treatment|"Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation~Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.~The maximum duration of procedure is 90 minutes, after liver mobilization.~Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)"
11214218|NCT02291133|EG000|Reported Event|Electrochemotherapy Treatment|"Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation~Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.~The maximum duration of procedure is 90 minutes, after liver mobilization.~Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)"
11214219|NCT02291237|BG000|Baseline|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
11214220|NCT02291237|BG001|Baseline|Placebo|Placebo to match eleclazine administered orally for up to at least 24 weeks
11214221|NCT02291237|BG002|Baseline|Total|Total of all reporting groups
11214222|NCT02291237|FG000|Participant Flow|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
11214223|NCT02291237|FG001|Participant Flow|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
11214224|NCT02291237|OG000|Outcome|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
11214225|NCT02291237|OG001|Outcome|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
11214226|NCT02291237|EG000|Reported Event|Eleclazine 30/3/6 mg|Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
11214227|NCT02291237|EG001|Reported Event|Placebo|Placebo to match eleclazine administered orally for at least 24 weeks
11214228|NCT02291289|BG000|Baseline|Cohort 1|Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt)
11214229|NCT02291289|BG001|Baseline|Cohort 2|Included participants with BRAFwt
11214230|NCT02291289|BG002|Baseline|Cohort 3|Included participants with human epidermal growth factor receptor 2 positive (HER2+)
11214231|NCT02291289|BG003|Baseline|Cohort 4|Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut)
11214232|NCT02291289|BG004|Baseline|Total|Total of all reporting groups
11214233|NCT02291289|FG000|Participant Flow|Cohort 1: Induction Phase (IP)|Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214234|NCT02291289|FG001|Participant Flow|Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib|Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) will receive 1600-2400 milligrams per square meter (mg/m^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
11214235|NCT02291289|FG002|Participant Flow|Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214236|NCT02291289|FG003|Participant Flow|Cohort 2 (IP)|Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11337572|NCT03587974|BG000|Baseline|REACH-VN|"In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months~REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease"
11337573|NCT03587974|BG001|Baseline|Enhanced Control|Single session with education about nature of dementia
11268693|NCT02703909|OG003|Outcome|Deep NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268694|NCT02703909|OG000|Outcome|Opioid Requirement-Subjects Who Had IP of 10 mm During Surgery|This variable reflects the amount of opioid required by the subjects in which the IP was 10 mm for the entire surgery.
11268695|NCT02703909|OG001|Outcome|Opioid Requirement -Subjects Who Had P of 15 mm During Surgery|This variable reports the amount of opioid required in subjects who had an IP of 15 mm for the entire surgery or had their IP increase from 10 mm to 15 mm at the start of surgery.
11268696|NCT02703909|EG000|Reported Event|Moderate NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268697|NCT02703909|EG001|Reported Event|Moderate NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268698|NCT02703909|EG002|Reported Event|Deep NMB + 10 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268699|NCT02703909|EG003|Reported Event|Deep NMB + 15 mm IP|"participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.~Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment~Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment"
11268700|NCT02703948|BG000|Baseline|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
11268701|NCT02703948|FG000|Participant Flow|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
11268702|NCT02703948|OG000|Outcome|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
11268703|NCT02703948|EG000|Reported Event|Restylane Silk With Lidocaine|Restylane Silk with Lidocaine
11268704|NCT02703987|BG000|Baseline|Sequence 1|Test at visit 3, Control at visit 4
11268705|NCT02703987|BG001|Baseline|Sequence 2|Control at visit 3, Test at visit 4
11268706|NCT02703987|BG002|Baseline|Total|Total of all reporting groups
11268707|NCT02703987|FG000|Participant Flow|Sequence 1 (Test at Visit 3 Followed by Control at Visit 4)|"Test product: 35g of Gallia Lactofidus 1 + 11.2g lactose to match an oral load of 20g lactose, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins~Control product: 35g of Nursie 1 + 10g maltodextrin to match an oral load of 20g lactose and the carbohydrate load as test product, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins."
11268708|NCT02703987|FG001|Participant Flow|Sequence 2 (Control at Visit 3 Followed by Test at Visit 4)|"Control product: 35g of Nursie 1 + 10g maltodextrin to match an oral load of 20g lactose and the carbohydrate load as test product, 250mL (reconstituted), once as breakfast, had to be consumed within 10~Test product: 35g of Gallia Lactofidus 1 + 11.2g lactose to match an oral load of 20g lactose, 250mL (reconstituted), once as breakfast, had to be consumed within 10 mins"
11268709|NCT02703987|OG000|Outcome|Control|Non-fermented infant milk formula
11268710|NCT02703987|OG001|Outcome|Test|Fermented infant milk formula
11268711|NCT02703987|EG000|Reported Event|Control|Non-fermented infant milk formula
11268712|NCT02703987|EG001|Reported Event|Test|Fermented infant milk formula
11268713|NCT02704091|BG000|Baseline|Diosmectite|"Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268714|NCT02704091|BG001|Baseline|Placebo|"Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268715|NCT02704091|BG002|Baseline|Total Title|
11268716|NCT02704091|FG000|Participant Flow|Diosmectite|"Participants received diosmectite as 2 sachets, three times a day (TID) (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11337574|NCT03587974|BG002|Baseline|Total|Total of all reporting groups
11268717|NCT02704091|FG001|Participant Flow|Placebo|"Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268718|NCT02704091|OG000|Outcome|Diosmectite|"Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268719|NCT02704091|OG001|Outcome|Placebo|"Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268720|NCT02704091|EG000|Reported Event|Diosmectite|"Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268721|NCT02704091|EG001|Reported Event|Placebo|"Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.~The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days)."
11268722|NCT02704104|BG000|Baseline|Overall|Characteristics of the 46 patients enrolled in the study
11268723|NCT02704104|FG000|Participant Flow|All Study Participants|All study participants had two freshly excised lesions, each randomized to either application of a topical hemostatic device (AC5) or control (saline) treatment.
11268724|NCT02704104|OG000|Outcome|AC5 Topical Hemostatic Device|The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions
11268725|NCT02704104|OG001|Outcome|Control|The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
11268726|NCT02704104|OG000|Outcome|Wounds Treated With AC5 Topical Hemostatic Device|The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of wounds
11268727|NCT02704104|OG001|Outcome|Wounds Treated With Control|The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to wounds
11268728|NCT02704104|EG000|Reported Event|AC5 Topical Hemostatic Device|"The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion~AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient"
11268729|NCT02704104|EG001|Reported Event|Control|"The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion~AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient"
11268730|NCT02704143|BG000|Baseline|Combination of Cyberknife With S-1|"Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.~combination of Cyberknife with sequential S-1: Radiation therapy combined with sequential chemotherapy"
11268731|NCT02704143|FG000|Participant Flow|Combination of Cyberknife With S-1|"Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.~combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy"
11268732|NCT02704143|OG000|Outcome|Combination of Cyberknife With S-1|"Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.~combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy"
11268733|NCT02704143|EG000|Reported Event|Combination of Cyberknife With S-1|"Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.~combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy"
11268734|NCT02704689|BG000|Baseline|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
11268735|NCT02704689|FG000|Participant Flow|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
11268736|NCT02704689|OG000|Outcome|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
11268737|NCT02704689|EG000|Reported Event|AccuLIF TL|All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
11268738|NCT02704702|BG000|Baseline|Sequence 2 (ACB)|"Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268739|NCT02704702|BG001|Baseline|Sequence 3 (BAC)|"Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268740|NCT02704702|BG002|Baseline|Sequence 1 (ABC)|"Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268741|NCT02704702|BG003|Baseline|Sequence 4 (BCA)|"Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268742|NCT02704702|BG004|Baseline|Sequence 5 (CAB)|"Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268743|NCT02704702|BG005|Baseline|Sequence 6 (CBA)|"Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268744|NCT02704702|BG006|Baseline|Total|Total of all reporting groups
11268745|NCT02704702|FG000|Participant Flow|Sequence 1 (ABC)|"Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268746|NCT02704702|FG001|Participant Flow|Sequence 2 (ACB)|"Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268747|NCT02704702|FG002|Participant Flow|Sequence 3 (BAC)|"Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268748|NCT02704702|FG003|Participant Flow|Sequence 4 (BCA)|"Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268749|NCT02704702|FG004|Participant Flow|Sequence 5 (CAB)|"Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268750|NCT02704702|FG005|Participant Flow|Sequence 6 (CBA)|"Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)~There will be a washout of at least 7 days between the each period.~Fimasartan~Rosuvastatin~Fimasartan + Rosuvastatin"
11268751|NCT02704702|OG000|Outcome|Treatment A(Single Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268752|NCT02704702|OG001|Outcome|Treatment A(Multiple Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268753|NCT02704702|OG002|Outcome|Treatment B(Single Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268754|NCT02704702|OG003|Outcome|Treatment B(Multiple Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268755|NCT02704702|OG004|Outcome|Treatment C(Single Dose_Fimasartan)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268756|NCT02704702|OG005|Outcome|Treatment C(Single Dose_Rosuvastatin)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268757|NCT02704702|OG006|Outcome|Treatment C(Multiple Dose_Fimasartan)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268758|NCT02704702|OG007|Outcome|Treatment C(Multiple Dose_Rosuvastatin)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268759|NCT02704702|OG005|Outcome|Treatment C(Multiple Dose_Fimasartan)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268760|NCT02704702|OG006|Outcome|Treatment C(Single Dose_Rosuvastatin)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268761|NCT02704702|EG000|Reported Event|Treatment A(Single Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268762|NCT02704702|EG001|Reported Event|Treatment A(Multiple Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268763|NCT02704702|EG002|Reported Event|Treatment B(Single Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268764|NCT02704702|EG003|Reported Event|Treatment B(Multiiple Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268765|NCT02704702|EG004|Reported Event|Treatment C(Single Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268766|NCT02704702|EG005|Reported Event|Treatment C(Multiple Dose)|"Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)~There will be a washout of at least 7 days between the each period.~Treatment A: Fimasartan~Treatment B: Rosuvastatin~Treatment C: Fimasartan + Rosuvastatin"
11268767|NCT02705105|BG000|Baseline|All in Phase 1 Cohort|All subjects in dose-finding cohort
11268768|NCT02705105|BG001|Baseline|NSCLC, Squamous Cell|Subjects in expansion cohort with squamous cell NSCLC
11268769|NCT02705105|BG002|Baseline|NSCLC, Nonsquamous, PD-L1 Non-Expressing|Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
11268770|NCT02705105|BG003|Baseline|Squamous Cell Carcinoma of Head and Neck|Subjects in expansion cohort with head & neck squamous cell carcinoma
11268771|NCT02705105|BG004|Baseline|Colorectal Carcinoma, Non-MSI High|Subjects in expansion cohort with colorectal carcinoma
11268772|NCT02705105|BG005|Baseline|Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma|Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
11268773|NCT02705105|BG006|Baseline|Hepatocellular Carcinoma (HCC)|Subjects in expansion cohort with hepatocellular carcinoma
11268774|NCT02705105|BG007|Baseline|Pancreatic Adenocarcinoma|Subjects in expansion cohort with pancreatic adenocarcinoma
11268775|NCT02705105|BG008|Baseline|Total|Total of all reporting groups
11268776|NCT02705105|FG000|Participant Flow|Phase 1|Dose-finding cohort to identify the maximum tolerated dose (MTD), or the highest protocol-defined dose in the absence of exceeding the MTD, for the combination regimen.
11268777|NCT02705105|FG001|Participant Flow|Phase 2|Expansion cohort, subjects were treated with the highest dose of the combination regimen that was considered tolerable in Phase 1.
11268778|NCT02705105|OG000|Outcome|All in Phase 1 Cohort|All subjects in dose-finding cohort
11268779|NCT02705105|OG001|Outcome|NSCLC, Squamous Cell|Subjects in expansion cohort with squamous cell NSCLC
11268780|NCT02705105|OG002|Outcome|NSCLC, Nonsquamous, PD-L1 Non-expressing|Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
11268781|NCT02705105|OG003|Outcome|Squamous Cell Carcinoma of Head and Neck|Subjects in expansion cohort with head & neck squamous cell carcinoma
11268782|NCT02705105|OG004|Outcome|Colorectal Carcinoma, Non-MSI Hign|Subjects in expansion cohort with colorectal carcinoma
11268783|NCT02705105|OG005|Outcome|Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma|Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
11268784|NCT02705105|OG006|Outcome|Hepatocellular Carcinoma|Subjects in expansion cohort with hepatocellular carcinoma
11268785|NCT02705105|OG007|Outcome|Pancreatic Adenocarcinoma|Subjects in expansion cohort with pancreatic adenocarcinoma
11268786|NCT02705105|EG000|Reported Event|All in Phase 1 Cohort|All subjects in dose-finding cohort
11268787|NCT02705105|EG001|Reported Event|NSCLC, Squamous Cell|Subjects in expansion cohort with squamous cell NSCLC
11268788|NCT02705105|EG002|Reported Event|NSCLC, Nonsquamous, PD-L1 Non-Expressing|Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC
11268789|NCT02705105|EG003|Reported Event|Squamous Cell Carcinoma of Head and Neck|Subjects in expansion cohort with head & neck squamous cell carcinoma
11268790|NCT02705105|EG004|Reported Event|Colorectal Carcinoma, Non-MSI High|Subjects in expansion cohort with colorectal carcinoma
11268791|NCT02705105|EG005|Reported Event|Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma|Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma
11268792|NCT02705105|EG006|Reported Event|Hepatocellular Carcinoma (HCC)|Subjects in expansion cohort with hepatocellular carcinoma
11268793|NCT02705105|EG007|Reported Event|Pancreatic Adenocarcinoma|Subjects in expansion cohort with pancreatic adenocarcinoma
11268794|NCT02705352|BG000|Baseline|5-Fluorouracil|"Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~5-Fluorouracil: Treatment medication"
11268795|NCT02705352|BG001|Baseline|Normal Saline|"Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~Normal saline: Placebo"
11268796|NCT02705352|BG002|Baseline|Total|Total of all reporting groups
11268797|NCT02705352|FG000|Participant Flow|5-Fluorouracil|"Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~5-Fluorouracil: Treatment medication"
11268798|NCT02705352|FG001|Participant Flow|Normal Saline|"Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~Normal saline: Placebo"
11268799|NCT02705352|OG000|Outcome|5-Fluorouracil|"Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~5-Fluorouracil: Treatment medication"
11268800|NCT02705352|OG001|Outcome|Normal Saline|"Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~Normal saline: Placebo"
11268801|NCT02705352|EG000|Reported Event|5-Fluorouracil|"Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~5-Fluorouracil: Treatment medication"
11268802|NCT02705352|EG001|Reported Event|Normal Saline|"Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.~Normal saline: Placebo"
11268803|NCT02705365|BG000|Baseline|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268804|NCT02705365|BG001|Baseline|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268805|NCT02705365|BG002|Baseline|Total|Total of all reporting groups
11268806|NCT02705365|FG000|Participant Flow|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268807|NCT02705365|FG001|Participant Flow|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268808|NCT02705365|OG000|Outcome|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268809|NCT02705365|OG001|Outcome|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268810|NCT02705365|EG000|Reported Event|Patient Navigation|"Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.~Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268811|NCT02705365|EG001|Reported Event|Usual Care|"The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.~Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance."
11268812|NCT02705586|BG000|Baseline|Only One Arm - Open Label Study|Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
11268813|NCT02705586|FG000|Participant Flow|Only One Arm - Open Label Study|Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
11268814|NCT02705586|OG000|Outcome|Only One Arm - Open Label Study|Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
11268815|NCT02705586|EG000|Reported Event|Only One Arm - Open Label Study|Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
11268816|NCT02705625|BG000|Baseline|MIV-711:100 mg|MIV-711 100 mg administered orally once daily for a total of 26 weeks
11268817|NCT02705625|BG001|Baseline|MIV-711:200 mg|MIV-711 200 mg administered orally once daily for a total of 26 weeks
11268818|NCT02705625|BG002|Baseline|Placebo|Placebo manufactured to mimic MIV-711 capsule administered orally once daily for a total of 26 weeks
11268819|NCT02705625|BG003|Baseline|Total|Total of all reporting groups
11268820|NCT02705625|FG000|Participant Flow|MIV-711:100 mg|MIV-711 100 mg administered orally once daily for a total of 26 weeks
11268821|NCT02705625|FG001|Participant Flow|MIV-711:200 mg|MIV-711 200 mg administered orally once daily for a total of 26 weeks
11268822|NCT02705625|FG002|Participant Flow|Placebo|Placebo manufactured to mimic MIV-711 capsule administered orally once daily for a total of 26 weeks
11268823|NCT02705625|OG000|Outcome|MIV-711:100 mg|MIV-711 100 mg administered orally once daily for a total of 26 weeks
11268824|NCT02705625|OG001|Outcome|MIV-711:200 mg|MIV-711 200 mg administered orally once daily for a total of 26 weeks
11268825|NCT02705625|OG002|Outcome|Placebo|Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
11268826|NCT02705625|EG000|Reported Event|MIV-711:100 mg|MIV-711 100 mg administered orally once daily for a total of 26 weeks
11268827|NCT02705625|EG001|Reported Event|MIV-711:200 mg|MIV-711 200 mg administered orally once daily for a total of 26 weeks
11268828|NCT02705625|EG002|Reported Event|Placebo|Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
11268829|NCT02705716|BG000|Baseline|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268830|NCT02705716|BG001|Baseline|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268831|NCT02705716|BG002|Baseline|Total|Total of all reporting groups
11268832|NCT02705716|FG000|Participant Flow|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268833|NCT02705716|FG001|Participant Flow|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268834|NCT02705716|OG000|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268835|NCT02705716|OG001|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
10970152|NCT00909155|OG002|Outcome|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
11268836|NCT02705716|EG000|Reported Event|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268837|NCT02705716|EG001|Reported Event|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11268838|NCT02705807|BG000|Baseline|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
11268839|NCT02705807|FG000|Participant Flow|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
11268840|NCT02705807|OG000|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
11268841|NCT02705807|EG000|Reported Event|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
11268842|NCT02706041|BG000|Baseline|Damage Control Laparotomy|"Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.~Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed."
11268843|NCT02706041|BG001|Baseline|Definitive Closure Laparotomy|"Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.~Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy."
11268844|NCT02706041|BG002|Baseline|Total|Total of all reporting groups
11268845|NCT02706041|FG000|Participant Flow|Damage Control Laparotomy|"Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.~Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed."
11268846|NCT02706041|FG001|Participant Flow|Definitive Closure Laparotomy|"Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.~Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy."
11268847|NCT02706041|OG000|Outcome|Damage Control Laparotomy|"Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.~Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed."
11268848|NCT02706041|OG001|Outcome|Definitive Closure Laparotomy|"Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.~Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy."
11268849|NCT02706041|EG000|Reported Event|Damage Control Laparotomy|"Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.~Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed."
11268850|NCT02706041|EG001|Reported Event|Definitive Closure Laparotomy|"Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.~Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy."
11268851|NCT02706249|BG000|Baseline|A: Standard Dose Enoxaparin|"Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.~After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.~Enoxaparin"
11268852|NCT02706249|BG001|Baseline|B: Weight Adjusted Enoxaparin|"Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.~On study Enoxaparin will be administered for up 14 days during hospitalization.~Enoxaparin"
11268853|NCT02706249|BG002|Baseline|Total|Total of all reporting groups
11268854|NCT02706249|FG000|Participant Flow|A: Standard Dose Enoxaparin|"Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.~After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.~Enoxaparin"
11268855|NCT02706249|FG001|Participant Flow|B: Weight Adjusted Enoxaparin|"Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.~On study Enoxaparin will be administered for up 14 days during hospitalization.~Enoxaparin"
11268856|NCT02706249|OG000|Outcome|A: Standard Dose Enoxaparin|Participants will receive Enoxaparin 40 mg subcutaneously once daily.
11268857|NCT02706249|OG001|Outcome|B: Weight Adjusted Enoxaparin|Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily
11268858|NCT02706249|OG000|Outcome|A: Standard Dose Enoxaparin|Participants will receive Enoxaparin 40 mg subcutaneously once daily. .
11268859|NCT02706249|OG001|Outcome|B: Weight Adjusted Enoxaparin|Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily.
11268860|NCT02706249|EG000|Reported Event|A: Standard Dose Enoxaparin|"Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.~After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.~Enoxaparin"
11268861|NCT02706249|EG001|Reported Event|B: Weight Adjusted Enoxaparin|"Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.~On study Enoxaparin will be administered for up 14 days during hospitalization.~Enoxaparin"
11268862|NCT02706327|BG000|Baseline|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268863|NCT02706327|BG001|Baseline|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268864|NCT02706327|BG002|Baseline|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
11268865|NCT02706327|BG003|Baseline|Total|Total of all reporting groups
11268866|NCT02706327|FG000|Participant Flow|CAD/CAM|"8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268867|NCT02706327|FG001|Participant Flow|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268868|NCT02706327|FG002|Participant Flow|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
11268869|NCT02706327|OG000|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268870|NCT02706327|OG001|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268871|NCT02706327|OG002|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
11268872|NCT02706327|EG000|Reported Event|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program~CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268873|NCT02706327|EG001|Reported Event|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program~Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
11268874|NCT02706327|EG002|Reported Event|Control|"8-week follow-up with placebo insole and home based exercise program~Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
11268875|NCT02706483|BG000|Baseline|Plecanatide|"Plecanatide 6.0 mg tablets~Plecanatide"
11268876|NCT02706483|FG000|Participant Flow|Plecanatide|"Plecanatide 6.0 mg tablets~Plecanatide"
11268877|NCT02706483|OG000|Outcome|Plecanatide|"Plecanatide 6.0 mg tablets~Plecanatide"
11268878|NCT02706483|EG000|Reported Event|Plecanatide|"Plecanatide 6.0 mg tablets~Plecanatide"
11268879|NCT02706717|BG000|Baseline|Visbiome Extra Strength|Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268880|NCT02706717|BG001|Baseline|Placebo for Visbiome Extra Strength|Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268881|NCT02706717|BG002|Baseline|Total|Total of all reporting groups
11268882|NCT02706717|FG000|Participant Flow|Visbiome Extra Strength|Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268883|NCT02706717|FG001|Participant Flow|Placebo for Visbiome Extra Strength|Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268884|NCT02706717|OG000|Outcome|Visbiome Extra Strength|Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268885|NCT02706717|OG001|Outcome|Placebo for Visbiome Extra Strength|Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268886|NCT02706717|EG000|Reported Event|Visbiome Extra Strength|Visibiome: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268887|NCT02706717|EG001|Reported Event|Placebo for Visbiome Extra Strength|Placebo: From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
11268888|NCT02706834|BG000|Baseline|Cohort 1, Sequence I|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11214237|NCT02291289|FG004|Participant Flow|Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab|Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m^2 5-FU via 46-hour IV infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214238|NCT02291289|FG005|Participant Flow|Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214239|NCT02291289|FG006|Participant Flow|Cohort 3 (IP)|Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214240|NCT02291289|FG007|Participant Flow|Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab|Participants with human epidermal growth factor receptor 2 positive (HER2+) will receive 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
11214241|NCT02291289|FG008|Participant Flow|Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214242|NCT02291289|FG009|Participant Flow|Cohort 4 (IP)|Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214243|NCT02291289|FG010|Participant Flow|Cohort 4 (MP): Cobimetinib,Atezolizumab|Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) will receive 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214244|NCT02291289|FG011|Participant Flow|Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214245|NCT02291289|OG000|Outcome|Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib|Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) will receive 1600-2400 milligrams per square meter (mg/m^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
11214246|NCT02291289|OG001|Outcome|Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214247|NCT02291289|OG002|Outcome|Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab|Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m^2 5-FU via 46-hour IV infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214248|NCT02291289|OG003|Outcome|Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214249|NCT02291289|OG004|Outcome|Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab|Participants with human epidermal growth factor receptor 2 positive (HER2+) will receive 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
11214250|NCT02291289|OG005|Outcome|Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214251|NCT02291289|OG006|Outcome|Cohort 4 (MP): Cobimetinib,Atezolizumab|Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) will receive 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214252|NCT02291289|OG007|Outcome|Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214253|NCT02291289|OG001|Outcome|Cohort 1 Control(MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214254|NCT02291289|OG002|Outcome|Cohort 2(MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab|Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m^2 5-FU via 46-hour IV infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214255|NCT02291289|OG001|Outcome|Cohort 1 Control(MP):5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214256|NCT02291289|EG000|Reported Event|Cohort 1: Induction Phase (IP)|Included participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214257|NCT02291289|EG001|Reported Event|Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib|Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) will receive 1600-2400 milligrams per square meter (mg/m^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth.
11214258|NCT02291289|EG002|Reported Event|Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214259|NCT02291289|EG003|Reported Event|Cohort 2 (IP)|Included participants with BRAFwt. All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214260|NCT02291289|EG004|Reported Event|Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab|Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m^2 5-FU via 46-hour IV infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle.
11214261|NCT02291289|EG005|Reported Event|Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214262|NCT02291289|EG006|Reported Event|Cohort 3 (IP)|Included participants with human epidermal growth factor receptor 2 positive (HER2+). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214263|NCT02291289|EG007|Reported Event|Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab|Participants with human epidermal growth factor receptor 2 positive (HER2+) will receive 1000 mg/m^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses.
11214264|NCT02291289|EG008|Reported Event|Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214265|NCT02291289|EG009|Reported Event|Cohort 4 (IP)|Included participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All study participants received either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab during Induction Treatment.
11214266|NCT02291289|EG010|Reported Event|Cohort 4 (MP): Cobimetinib,Atezolizumab|Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) will receive 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle.
11268889|NCT02706834|BG001|Baseline|Cohort 1, Sequence II|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268890|NCT02706834|BG002|Baseline|Cohort 1, Sequence III|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268891|NCT02706834|BG003|Baseline|Cohort 1, Sequence IV|Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268892|NCT02706834|BG004|Baseline|Cohort 2, Sequence I|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268893|NCT02706834|BG005|Baseline|Cohort 2, Sequence II|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268894|NCT02706834|BG006|Baseline|Cohort 2, Sequence III|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268895|NCT02706834|BG007|Baseline|Cohort 2, Sequence IV|Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.
11268896|NCT02706834|BG008|Baseline|Cohort 3, Sequence I|Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268897|NCT02706834|BG009|Baseline|Cohort 3, Sequence II|Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268898|NCT02706834|BG010|Baseline|Cohort 3, Sequence III|Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268899|NCT02706834|BG011|Baseline|Total|Total of all reporting groups
11268900|NCT02706834|FG000|Participant Flow|Cohort 1, Sequence I|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268901|NCT02706834|FG001|Participant Flow|Cohort 1, Sequence II|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268902|NCT02706834|FG002|Participant Flow|Cohort 1, Sequence III|Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11214267|NCT02291289|EG011|Reported Event|Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab|Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle.
11214268|NCT02291302|BG000|Baseline|Environmental Intervention|"Active Classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11214269|NCT02291302|BG001|Baseline|Sham and Control (Control)|"Sham air purifiers and no school integrated pest management environmental intervention~No intervention (control): no integrated pest management and sham air purifier"
11214270|NCT02291302|BG002|Baseline|Active Air Purifier and Control|"Active air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11214271|NCT02291302|BG003|Baseline|Sham and Inegrated Pest|"Sham air purifiers and active school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11214272|NCT02291302|BG004|Baseline|Total|Total of all reporting groups
11214273|NCT02291302|FG000|Participant Flow|Environmental Intervention|"Active Classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11214274|NCT02291302|FG001|Participant Flow|Sham and Control (Control)|"Sham air purifiers and no school integrated pest management environmental intervention~No intervention (control): no integrated pest management and sham air purifier"
11214275|NCT02291302|FG002|Participant Flow|Active Air Purifier and Control|"Active air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11214276|NCT02291302|FG003|Participant Flow|Sham and Inegrated Pest|"Sham air purifiers and active school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11214277|NCT02291302|OG000|Outcome|Environmental Intervention|"Active Classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11214278|NCT02291302|OG001|Outcome|Sham and Control (Control)|"Sham air purifiers and no school integrated pest management environmental intervention~No intervention (control): no integrated pest management and sham air purifier"
11214279|NCT02291302|OG002|Outcome|Active Air Purifier and Control|"Active air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11214280|NCT02291302|OG003|Outcome|Sham and Inegrated Pest|"Sham air purifiers and active school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11214281|NCT02291302|EG000|Reported Event|Environmental Intervention|"Active Classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
11214282|NCT02291302|EG001|Reported Event|Sham and Control (Control)|"Sham air purifiers and no school integrated pest management environmental intervention~No intervention (control): no integrated pest management and sham air purifier"
11214283|NCT02291302|EG002|Reported Event|Active Air Purifier and Control|"Active air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
11214284|NCT02291302|EG003|Reported Event|Sham and Inegrated Pest|"Sham air purifiers and active school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
11214285|NCT02291419|BG000|Baseline|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
11214286|NCT02291419|BG001|Baseline|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
11214287|NCT02291419|BG002|Baseline|Total|Total of all reporting groups
11214288|NCT02291419|FG000|Participant Flow|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
11214289|NCT02291419|FG001|Participant Flow|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
11214290|NCT02291419|OG000|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
11214291|NCT02291419|OG001|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
11214292|NCT02291419|EG000|Reported Event|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
11214293|NCT02291419|EG001|Reported Event|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
11214294|NCT02291432|BG000|Baseline|AMDC-USR|Single intraurethral injection of 150 x 10^6 autologous muscle-derived cells (AMDCs).
11214295|NCT02291432|FG000|Participant Flow|AMDC-USR|Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
11214296|NCT02291432|OG000|Outcome|AMDC-USR|Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
11214297|NCT02291432|EG000|Reported Event|AMDC-USR|Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
11214298|NCT02291510|BG000|Baseline|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214299|NCT02291510|BG001|Baseline|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214300|NCT02291510|BG002|Baseline|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214301|NCT02291510|BG003|Baseline|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214302|NCT02291510|BG004|Baseline|Total|Total of all reporting groups
11214303|NCT02291510|FG000|Participant Flow|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214304|NCT02291510|FG001|Participant Flow|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214305|NCT02291510|FG002|Participant Flow|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214306|NCT02291510|FG003|Participant Flow|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
11214307|NCT02291510|OG000|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
11214308|NCT02291510|OG001|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
11214309|NCT02291510|OG002|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
11214310|NCT02291510|OG003|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
11214311|NCT02291510|EG000|Reported Event|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
11214312|NCT02291510|EG001|Reported Event|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
11214313|NCT02291510|EG002|Reported Event|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
11214314|NCT02291510|EG003|Reported Event|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
11214315|NCT02291549|BG000|Baseline|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11214316|NCT02291549|BG001|Baseline|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11214317|NCT02291549|BG002|Baseline|Total|Total of all reporting groups
11214318|NCT02291549|FG000|Participant Flow|S8 Sinus Implant|"Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200 mcg) once daily"
11214319|NCT02291549|FG001|Participant Flow|Control|"Bilateral in-office sham procedure~Mometasone furoate nasal spray (200 mcg) once daily"
11214320|NCT02291549|OG000|Outcome|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11214321|NCT02291549|OG001|Outcome|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11214322|NCT02291549|OG000|Outcome|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200 mcg) once daily"
11214323|NCT02291549|OG001|Outcome|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200 mcg) once daily"
11214324|NCT02291549|EG000|Reported Event|Treatment|"In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses~Mometasone furoate nasal spray (200mcg) once daily"
11214325|NCT02291549|EG001|Reported Event|Control|"In-office bilateral sham procedure~Mometasone furoate nasal spray (200mcg) once daily"
11214326|NCT02291601|BG000|Baseline|CHG, Vehicle, Comparator CHG|Single applications of products. 3 min application for CHG and vehicle. Comparator CHG applied according to instructions.
11214327|NCT02291601|FG000|Participant Flow|CHG Cloth|CHG 3 min application
11214328|NCT02291601|FG001|Participant Flow|Vehicle|Vehicle, 3 min application
11214329|NCT02291601|FG002|Participant Flow|Comparator CHG|marketed CHG - application done per products instructions for use
11214330|NCT02291601|OG000|Outcome|CHG Abdomen|single application on abdomen
11214331|NCT02291601|OG001|Outcome|CHG Groin|single application on groin.
11214332|NCT02291601|OG002|Outcome|Vehicle Abdomen|single application on abdomen
11214333|NCT02291601|OG003|Outcome|Vehicle Groin|single application on groin
11214334|NCT02291601|OG004|Outcome|Comparator Abdomen|single application on abdomen
11214335|NCT02291601|OG005|Outcome|Comparator Groin|single application of groin
11214336|NCT02291601|EG000|Reported Event|CHG Cloth|single application
11214337|NCT02291601|EG001|Reported Event|Vehicle|Excipients of CHG product only.
11214338|NCT02291601|EG002|Reported Event|Comparator CHG|2% CHG solution
11214339|NCT02291614|BG000|Baseline|AMG 211 200 µg/Day for 7/14 Days|In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214340|NCT02291614|BG001|Baseline|AMG 211 200 µg/Day for 14 Days|Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214341|NCT02291614|BG002|Baseline|AMG 211 400 µg/Day for 14 Days|Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214342|NCT02291614|BG003|Baseline|AMG 211 800 µg/Day for 14 Days|Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214343|NCT02291614|BG004|Baseline|AMG 211 1600 µg/Day for 14 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214344|NCT02291614|BG005|Baseline|AMG 211 1600 µg/Day for 28 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214345|NCT02291614|BG006|Baseline|AMG 211 3200 µg/Day for 14 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214346|NCT02291614|BG007|Baseline|AMG 211 3200 µg/Day for 28 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214347|NCT02291614|BG008|Baseline|AMG 211 6400 µg/Day for 14 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214348|NCT02291614|BG009|Baseline|AMG 211 6400 µg/Day for 28 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214349|NCT02291614|BG010|Baseline|AMG 211 12,800 µg/Day for 28 Days|Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214350|NCT02291614|BG011|Baseline|Total|Total of all reporting groups
11214351|NCT02291614|FG000|Participant Flow|AMG 211 200 µg/Day for 7/14 Days|In cycle 1 participants received 200 µg/day AMG 211 administered as a continuous intravenous (cIV) infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214352|NCT02291614|FG001|Participant Flow|AMG 211 200 µg/Day for 14 Days|Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214353|NCT02291614|FG002|Participant Flow|AMG 211 400 µg/Day for 14 Days|Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214354|NCT02291614|FG003|Participant Flow|AMG 211 800 µg/Day for 14 Days|Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214355|NCT02291614|FG004|Participant Flow|AMG 211 1600 µg/Day for 14 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214356|NCT02291614|FG005|Participant Flow|AMG 211 1600 µg/Day for 28 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214357|NCT02291614|FG006|Participant Flow|AMG 211 3200 µg/Day for 14 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214358|NCT02291614|FG007|Participant Flow|AMG 211 3200 µg/Day for 28 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214359|NCT02291614|FG008|Participant Flow|AMG 211 6400 µg/Day for 14 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214360|NCT02291614|FG009|Participant Flow|AMG 211 6400 µg/Day for 28 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214361|NCT02291614|FG010|Participant Flow|AMG 211 12,800 µg/Day for 28 Days|Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214362|NCT02291614|OG000|Outcome|AMG 211 200 µg/Day for 7/14 Days|In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214363|NCT02291614|OG001|Outcome|AMG 211 200 µg/Day for 14 Days|Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214364|NCT02291614|OG002|Outcome|AMG 211 400 µg/Day for 14 Days|Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214365|NCT02291614|OG003|Outcome|AMG 211 800 µg/Day for 14 Days|Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214366|NCT02291614|OG004|Outcome|AMG 211 1600 µg/Day for 14 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214367|NCT02291614|OG005|Outcome|AMG 211 1600 µg/Day for 28 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214368|NCT02291614|OG006|Outcome|AMG 211 3200 µg/Day for 14 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214369|NCT02291614|OG007|Outcome|AMG 211 3200 µg/Day for 28 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214370|NCT02291614|OG008|Outcome|AMG 211 6400 µg/Day for 14 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214371|NCT02291614|OG009|Outcome|AMG 211 6400 µg/Day for 28 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214372|NCT02291614|OG010|Outcome|AMG 211 12,800 µg/Day for 28 Days|Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214373|NCT02291614|OG005|Outcome|AMG 211 3200 µg/Day for 14 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214374|NCT02291614|OG006|Outcome|AMG 211 6400 µg/Day for 14 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214375|NCT02291614|OG000|Outcome|AMG 211 1600 µg/Day for 28 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214376|NCT02291614|OG001|Outcome|AMG 211 3200 µg/Day for 28 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214377|NCT02291614|OG002|Outcome|AMG 211 6400 µg/Day for 28 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214378|NCT02291614|OG003|Outcome|AMG 211 12,800 µg/Day for 28 Days|Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214379|NCT02291614|EG000|Reported Event|AMG 211 200 µg/Day for 7/14 Days|In cycle 1 participants received 200 µg/day AMG 211 administered as a cIV infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214380|NCT02291614|EG001|Reported Event|AMG 211 200 µg/Day for 14 Days|Participants received 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11268903|NCT02706834|FG003|Participant Flow|Cohort 1, Sequence IV|Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268904|NCT02706834|FG004|Participant Flow|Cohort 2, Sequence I|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268905|NCT02706834|FG005|Participant Flow|Cohort 2, Sequence II|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268906|NCT02706834|FG006|Participant Flow|Cohort 2, Sequence III|Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
11268907|NCT02706834|FG007|Participant Flow|Cohort 2, Sequence IV|Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.
11268908|NCT02706834|FG008|Participant Flow|Cohort 3, Sequence I|Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268909|NCT02706834|FG009|Participant Flow|Cohort 3, Sequence II|Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268910|NCT02706834|FG010|Participant Flow|Cohort 3, Sequence III|Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
11268911|NCT02706834|OG000|Outcome|Cohort 1: Placebo|Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
11268912|NCT02706834|OG001|Outcome|Cohort 1: TAK-828 0.1 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268913|NCT02706834|OG002|Outcome|Cohort 1: TAK-828 0.5 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268914|NCT02706834|OG003|Outcome|Cohort 1: TAK-828 15 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268915|NCT02706834|OG004|Outcome|Cohort 1: TAK-828 100 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
11268916|NCT02706834|OG005|Outcome|Cohort 1: TAK-828 100 mg/ Fed|Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
11268917|NCT02706834|OG006|Outcome|Cohort 2: Placebo|Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
11268918|NCT02706834|OG007|Outcome|Cohort 2: TAK-828 3 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268919|NCT02706834|OG008|Outcome|Cohort 2: TAK-828 50 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268920|NCT02706834|OG009|Outcome|Cohort 2: TAK-828 200 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268921|NCT02706834|OG010|Outcome|Cohort 2: TAK-828 100 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
11268922|NCT02706834|OG011|Outcome|Cohort 2: TAK-828 100 mg/ Fed|Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
11268923|NCT02706834|OG012|Outcome|Cohort 3: Placebo|Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
11268924|NCT02706834|OG013|Outcome|Cohort 3: TAK-828 15 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268925|NCT02706834|OG014|Outcome|Cohort 3: TAK-828 100 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268926|NCT02706834|OG015|Outcome|Cohort 3: TAK-828 150 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268927|NCT02706834|OG000|Outcome|TAK-828 0.1 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268928|NCT02706834|OG001|Outcome|TAK-828 0.5 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268929|NCT02706834|OG002|Outcome|TAK-828 3 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268930|NCT02706834|OG003|Outcome|TAK-828 15 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268931|NCT02706834|OG004|Outcome|TAK-828 50 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268932|NCT02706834|OG005|Outcome|TAK-828 100 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
11268933|NCT02706834|OG006|Outcome|TAK-828 100 mg/ Fed in Non-Japanese Participants|Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
11268934|NCT02706834|OG007|Outcome|TAK-828 200 mg/ Fasted in Non-Japanese Participants|Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268935|NCT02706834|OG008|Outcome|TAK-828 15 mg/ Fasted in Japanese Participants|Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268936|NCT02706834|OG009|Outcome|TAK-828 100 mg/ Fasted in Japanese Participants|Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268937|NCT02706834|OG010|Outcome|TAK-828 150 mg/ Fasted in Japanese Participants|Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268938|NCT02706834|EG000|Reported Event|Cohort 1: Placebo|Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
11268939|NCT02706834|EG001|Reported Event|Cohort 1: TAK-828 0.1 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268940|NCT02706834|EG002|Reported Event|Cohort 1: TAK-828 0.5 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268941|NCT02706834|EG003|Reported Event|Cohort 1: TAK-828 15 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268942|NCT02706834|EG004|Reported Event|Cohort 1: TAK-828 100 mg/ Fasted|Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
11268943|NCT02706834|EG005|Reported Event|Cohort 1: TAK-828 100 mg/ Fed|Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
11268944|NCT02706834|EG006|Reported Event|Cohort 2: Placebo|Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
11268945|NCT02706834|EG007|Reported Event|Cohort 2: TAK-828 3 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268946|NCT02706834|EG008|Reported Event|Cohort 2: TAK-828 50 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268947|NCT02706834|EG009|Reported Event|Cohort 2: TAK-828 200 mg/ Fasted|Cohort 2: TAK-828 200 mg/ Fasted Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268948|NCT02706834|EG010|Reported Event|Cohort 2: TAK-828 100 mg/ Fasted|Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
11268949|NCT02706834|EG011|Reported Event|Cohort 2: TAK-828 100 mg/ Fed|Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
11268950|NCT02706834|EG012|Reported Event|Cohort 3: Placebo|Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
11268951|NCT02706834|EG013|Reported Event|Cohort 3: TAK-828 15 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
11268952|NCT02706834|EG014|Reported Event|Cohort 3: TAK-828 100 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
11268953|NCT02706834|EG015|Reported Event|Cohort 3: TAK-828 150 mg/ Fasted|Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
11268954|NCT02706873|BG000|Baseline|Methotrexate|Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
11268955|NCT02706873|BG001|Baseline|Upadacitinib 7.5 mg|Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268956|NCT02706873|BG002|Baseline|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268957|NCT02706873|BG003|Baseline|Upadacitinib 30 mg|Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268958|NCT02706873|BG004|Baseline|Total|Total of all reporting groups
11268959|NCT02706873|FG000|Participant Flow|Methotrexate|Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
11268960|NCT02706873|FG001|Participant Flow|Upadacitinib 7.5 mg|Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268961|NCT02706873|FG002|Participant Flow|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268962|NCT02706873|FG003|Participant Flow|Upadacitinib 30 mg|Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268963|NCT02706873|OG000|Outcome|Methotrexate|Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
11268964|NCT02706873|OG001|Outcome|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268965|NCT02706873|OG002|Outcome|Upadacitinib 30 mg|Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268966|NCT02706873|OG001|Outcome|Upadacitinib 7.5 mg|Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268967|NCT02706873|OG002|Outcome|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268968|NCT02706873|OG003|Outcome|Upadacitinib 30 mg|Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268969|NCT02706873|EG000|Reported Event|Methotrexate|Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
11268970|NCT02706873|EG001|Reported Event|Upadacitinib 7.5 mg|Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268971|NCT02706873|EG002|Reported Event|Upadacitinib 15 mg|Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268972|NCT02706873|EG003|Reported Event|Upadacitinib 30 mg|Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
11268973|NCT02706886|BG000|Baseline|Part A: SAD: Placebo|A single dose of matching placebo was administered SC.
11268974|NCT02706886|BG001|Baseline|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered SC.
11268975|NCT02706886|BG002|Baseline|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11268976|NCT02706886|BG003|Baseline|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11268977|NCT02706886|BG004|Baseline|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11268978|NCT02706886|BG005|Baseline|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebo-treated participants crossed over to their respective Part B lumasiran arms in Part B: MAD Study Day 85-End of Study and were then treated with lumasiran. The estimated total time on study was up to 546 days.
11268979|NCT02706886|BG006|Baseline|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268980|NCT02706886|BG007|Baseline|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268981|NCT02706886|BG008|Baseline|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268982|NCT02706886|BG009|Baseline|Total|Total of all reporting groups
11268983|NCT02706886|FG000|Participant Flow|Part A: SAD: Placebo|A single dose of matching placebo was administered subcutaneously (SC).
11268984|NCT02706886|FG001|Participant Flow|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered SC.
11268985|NCT02706886|FG002|Participant Flow|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11268986|NCT02706886|FG003|Participant Flow|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11268987|NCT02706886|FG004|Participant Flow|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11268988|NCT02706886|FG005|Participant Flow|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebo-treated participants crossed over to their respective Part B lumasiran arms in Part B: MAD Study Day 85-End of Study and were then treated with lumasiran. The estimated total time on study was up to 546 days.
11268989|NCT02706886|FG006|Participant Flow|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268990|NCT02706886|FG007|Participant Flow|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268991|NCT02706886|FG008|Participant Flow|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268992|NCT02706886|OG000|Outcome|Part A: SAD: Placebo|A single dose of matching placebo was administered SC.
11268993|NCT02706886|OG001|Outcome|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg Lumasiran was administered SC.
11268994|NCT02706886|OG002|Outcome|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg Lumasiran was administered SC.
11268995|NCT02706886|OG003|Outcome|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg Lumasiran was administered SC.
11268996|NCT02706886|OG004|Outcome|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg Lumasiran was administered SC.
11268997|NCT02706886|OG005|Outcome|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebo-treated participants crossed over to their respective Part B lumasiran arms in Part B: MAD Study Day 85-End of Study and were then treated with lumasiran. The estimated total time on study was up to 546 days.
11268998|NCT02706886|OG006|Outcome|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11268999|NCT02706886|OG007|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269000|NCT02706886|OG008|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269001|NCT02706886|OG000|Outcome|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered SC.
11269002|NCT02706886|OG001|Outcome|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11269003|NCT02706886|OG002|Outcome|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11269004|NCT02706886|OG003|Outcome|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11269005|NCT02706886|OG004|Outcome|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269006|NCT02706886|OG005|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269007|NCT02706886|OG006|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269008|NCT02706886|OG000|Outcome|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered subcutaneously (SC).
10847281|NCT00282568|EG000|Reported Event|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
10847282|NCT00282672|BG000|Baseline|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
10847283|NCT00282672|BG001|Baseline|LGD Radiofrequency Ablation|
10847284|NCT00282672|BG002|Baseline|HGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
10847285|NCT00282672|BG003|Baseline|HGD Radiofrequency Ablation|
10847286|NCT00282672|BG004|Baseline|Total|Total of all reporting groups
10847287|NCT00282672|FG000|Participant Flow|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
10847288|NCT00282672|FG001|Participant Flow|LGD Radiofrequency Ablation|
10847289|NCT00282672|FG002|Participant Flow|HGD Sham Procedure First Then HGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
10847290|NCT00282672|FG003|Participant Flow|HGD Radiofrequency Ablation|
10847291|NCT00282672|OG000|Outcome|LGD:Radiofrequency Ablation|
10847292|NCT00282672|OG001|Outcome|HGD:Radiofrequency Ablation|
10847293|NCT00282672|OG000|Outcome|LGD:Radiofrequency|
10847294|NCT00282672|OG001|Outcome|HGD:Radiofrequency|
10847295|NCT00282672|OG000|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|Crossed over to LGD:Radiofrequency
11269009|NCT02706886|OG000|Outcome|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11269010|NCT02706886|OG001|Outcome|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11269011|NCT02706886|OG002|Outcome|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11269012|NCT02706886|OG003|Outcome|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269013|NCT02706886|OG004|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269014|NCT02706886|OG005|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269015|NCT02706886|OG001|Outcome|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered SC.
11269016|NCT02706886|OG002|Outcome|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11269017|NCT02706886|OG003|Outcome|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11269018|NCT02706886|OG004|Outcome|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11092260|NCT01538615|EG000|Reported Event|HOME Plus Intervention|HOME Plus intervention: The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
11269019|NCT02706886|OG005|Outcome|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebotreated participants crossed over to their respective Part B lumasiran arms in Part B: MAD Study Day 85-End of Study and were then treated with lumasiran. The estimated total time on study was up to 546 days.
11269020|NCT02706886|OG000|Outcome|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebo-treated participants crossed over to their respective Part B lumasiran arms in Part B: MAD Study Day 85-End of Study and were then treated with lumasiran. The estimated total time on study was up to 546 days.
11269021|NCT02706886|OG001|Outcome|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269022|NCT02706886|OG002|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269023|NCT02706886|OG003|Outcome|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days. One participant from the Part B: MAD: Placebo arm crossed over to this lumasiran arm at Day 85. For this participant treatment with lumasiran started at Day 85.
11269024|NCT02706886|EG000|Reported Event|Part A: SAD: Placebo|A single dose of matching placebo was administered.
11269025|NCT02706886|EG001|Reported Event|Part A: SAD: Lumasiran 0.3 mg/kg|A single dose of 0.3 mg/kg lumasiran was administered subcutaneously (SC).
11269026|NCT02706886|EG002|Reported Event|Part A: SAD: Lumasiran 1.0 mg/kg|A single dose of 1.0 mg/kg lumasiran was administered SC.
11269027|NCT02706886|EG003|Reported Event|Part A: SAD: Lumasiran 3.0 mg/kg|A single dose of 3.0 mg/kg lumasiran was administered SC.
11269028|NCT02706886|EG004|Reported Event|Part A: SAD: Lumasiran 6.0 mg/kg|A single dose of 6.0 mg/kg lumasiran was administered SC.
11269029|NCT02706886|EG005|Reported Event|Part B: MAD: Placebo|Participants with primary hyperoxaluria type 1 (PH1) were treated with placebo matching one of the lumasiran dosages in the lumasiran arms (one placebo participant for each lumasiran arm). At Day 85 these placebo-treated participants crossed over to their respective Part B lumasiran arms in the All-Lumasiran-Treated Period. The estimated total time on study was up to 546 days.
11269030|NCT02706886|EG006|Reported Event|Part B: MAD: Lumasiran 1.0 mg/kg qM|Participants with PH1 were treated with 1.0 mg/kg lumasiran SC once monthly (qM) on Days 1, 29 and 57. The estimated total time on study was up to 546 days.
10847296|NCT00282672|OG001|Outcome|LGD:Radiofrequency|
11269031|NCT02706886|EG007|Reported Event|Part B: MAD: Lumasiran 3.0 mg/kg qM|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC qM on Days 1, 29 and 57. The estimated total time on study was up to 546 days.
11269032|NCT02706886|EG008|Reported Event|Part B: MAD: Lumasiran 3.0 mg/kg q3M|Participants with PH1 were treated with 3.0 mg/kg lumasiran SC once every three months (q3M) on Days 1 and 85. The estimated total time on study was up to 546 days.
11269033|NCT02706899|BG000|Baseline|33A (5 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269034|NCT02706899|BG001|Baseline|33A (10 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269035|NCT02706899|BG002|Baseline|Total|Total of all reporting groups
11269036|NCT02706899|FG000|Participant Flow|33A (5 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269037|NCT02706899|FG001|Participant Flow|33A (10 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269038|NCT02706899|OG000|Outcome|33A (5 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269039|NCT02706899|OG001|Outcome|33A (10 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269040|NCT02706899|EG000|Reported Event|33A (5 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269041|NCT02706899|EG001|Reported Event|33A (10 mcg/kg) + Azacitidine|"Vadastuximab talirine (33A) plus azacitidine~Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks~Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks"
11269042|NCT02706925|BG000|Baseline|Placebo|Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269043|NCT02706925|BG001|Baseline|BI 443651 10 μg|Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11092261|NCT01538615|EG001|Reported Event|Control|Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
11092262|NCT01538628|BG000|Baseline|SpaceOAR|Subjects randomized to receive SpaceOAR hydrogel.
11269044|NCT02706925|BG002|Baseline|BI 443651 30 μg|Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269045|NCT02706925|BG003|Baseline|BI 443651 100 μg|Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269046|NCT02706925|BG004|Baseline|BI 443651 300 μg|Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269047|NCT02706925|BG005|Baseline|BI 443651 900 μg|Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269048|NCT02706925|BG006|Baseline|BI 443651 1800 μg|Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269049|NCT02706925|BG007|Baseline|BI 443651 2700 μg|Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269050|NCT02706925|BG008|Baseline|BI 443651 3600 μg|Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269051|NCT02706925|BG009|Baseline|Total|Total of all reporting groups
11269052|NCT02706925|FG000|Participant Flow|Placebo|Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269053|NCT02706925|FG001|Participant Flow|BI 443651 10 μg|Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269054|NCT02706925|FG002|Participant Flow|BI 443651 30 μg|Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269055|NCT02706925|FG003|Participant Flow|BI 443651 100 μg|Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269056|NCT02706925|FG004|Participant Flow|BI 443651 300 μg|Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269057|NCT02706925|FG005|Participant Flow|BI 443651 900 μg|Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269058|NCT02706925|FG006|Participant Flow|BI 443651 1800 μg|Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269059|NCT02706925|FG007|Participant Flow|BI 443651 2700 μg|Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269060|NCT02706925|FG008|Participant Flow|BI 443651 3600 μg|Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269061|NCT02706925|OG000|Outcome|Placebo|Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269062|NCT02706925|OG001|Outcome|BI 443651 10 μg|Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269063|NCT02706925|OG002|Outcome|BI 443651 30 μg|Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269064|NCT02706925|OG003|Outcome|BI 443651 100 μg|Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269065|NCT02706925|OG004|Outcome|BI 443651 300 μg|Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269066|NCT02706925|OG005|Outcome|BI 443651 900 μg|Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269067|NCT02706925|OG006|Outcome|BI 443651 1800 μg|Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11092263|NCT01538628|BG001|Baseline|Control|Subjects randomized to not receive SpaceOAR hydrogel.
11092264|NCT01538628|BG002|Baseline|Total|Total of all reporting groups
11214381|NCT02291614|EG002|Reported Event|AMG 211 400 µg/Day for 14 Days|Participants received 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214382|NCT02291614|EG003|Reported Event|AMG 211 800 µg/Day for 14 Days|Participants received 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214383|NCT02291614|EG004|Reported Event|AMG 211 1600 µg/Day for 14 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214384|NCT02291614|EG005|Reported Event|AMG 211 1600 µg/Day for 28 Days|Participants received 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214385|NCT02291614|EG006|Reported Event|AMG 211 3200 µg/Day for 14 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214386|NCT02291614|EG007|Reported Event|AMG 211 3200 µg/Day for 28 Days|Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214387|NCT02291614|EG008|Reported Event|AMG 211 6400 µg/Day for 14 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
11214388|NCT02291614|EG009|Reported Event|AMG 211 6400 µg/Day for 28 Days|Participants received 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214389|NCT02291614|EG010|Reported Event|AMG 211 12,800 µg/Day for 28 Days|Participants received 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
11214390|NCT02291679|BG000|Baseline|Placebo|Matching placebo, once daily for 12 weeks
11214391|NCT02291679|BG001|Baseline|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
11214392|NCT02291679|BG002|Baseline|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
11214393|NCT02291679|BG003|Baseline|Total|Total of all reporting groups
11214394|NCT02291679|FG000|Participant Flow|Placebo|Matching placebo, once daily for 12 weeks
11214395|NCT02291679|FG001|Participant Flow|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
11214396|NCT02291679|FG002|Participant Flow|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
11214397|NCT02291679|OG000|Outcome|Placebo|Matching placebo, once daily for 12 weeks
11214398|NCT02291679|OG001|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
11214399|NCT02291679|EG000|Reported Event|Placebo|Matching placebo, once daily for 12 weeks
11214400|NCT02291679|EG001|Reported Event|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
11214401|NCT02291679|EG002|Reported Event|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
11214402|NCT02291718|BG000|Baseline|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
11214403|NCT02291718|BG001|Baseline|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
11214404|NCT02291718|BG002|Baseline|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
11214405|NCT02291718|BG003|Baseline|Total|Total of all reporting groups
11214406|NCT02291718|FG000|Participant Flow|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
11214407|NCT02291718|FG001|Participant Flow|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
11214408|NCT02291718|FG002|Participant Flow|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
11214409|NCT02291718|OG000|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
11214410|NCT02291718|OG001|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
11214411|NCT02291718|OG002|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
11214412|NCT02291718|EG000|Reported Event|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
11214413|NCT02291718|EG001|Reported Event|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
11214414|NCT02291718|EG002|Reported Event|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
11214415|NCT02291861|BG000|Baseline|Placebo|Placebo tablets taken twice daily for 12 weeks.
11214416|NCT02291861|BG001|Baseline|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
11214417|NCT02291861|BG002|Baseline|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
11214418|NCT02291861|BG003|Baseline|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
11214419|NCT02291861|BG004|Baseline|Total|Total of all reporting groups
11214420|NCT02291861|FG000|Participant Flow|Placebo|Placebo tablets taken twice daily for 12 weeks.
11214421|NCT02291861|FG001|Participant Flow|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
11214422|NCT02291861|FG002|Participant Flow|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
11214423|NCT02291861|FG003|Participant Flow|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
11214424|NCT02291861|OG000|Outcome|Placebo|Placebo tablets taken twice daily for 12 weeks.
11214425|NCT02291861|OG001|Outcome|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
11214426|NCT02291861|OG002|Outcome|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
11214427|NCT02291861|OG003|Outcome|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
11269068|NCT02706925|OG007|Outcome|BI 443651 2700 μg|Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269069|NCT02706925|OG008|Outcome|BI 443651 3600 μg|Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269070|NCT02706925|OG000|Outcome|BI 443651 10 μg|Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269071|NCT02706925|OG001|Outcome|BI 443651 30 μg|Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269072|NCT02706925|OG002|Outcome|BI 443651 100 μg|Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269073|NCT02706925|OG003|Outcome|BI 443651 300 μg|Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269074|NCT02706925|OG004|Outcome|BI 443651 900 μg|Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269075|NCT02706925|OG005|Outcome|BI 443651 1800 μg|Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269076|NCT02706925|OG006|Outcome|BI 443651 2700 μg|Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269077|NCT02706925|OG007|Outcome|BI 443651 3600 μg|Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269078|NCT02706925|EG000|Reported Event|Placebo|Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269079|NCT02706925|EG001|Reported Event|BI 443651 10 μg|Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269080|NCT02706925|EG002|Reported Event|BI 443651 30 μg|Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269081|NCT02706925|EG003|Reported Event|BI 443651 100 μg|Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269082|NCT02706925|EG004|Reported Event|BI 443651 300 μg|Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269083|NCT02706925|EG005|Reported Event|BI 443651 900 μg|Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269084|NCT02706925|EG006|Reported Event|BI 443651 1800 μg|Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269085|NCT02706925|EG007|Reported Event|BI 443651 2700 μg|Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269086|NCT02706925|EG008|Reported Event|BI 443651 3600 μg|Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
11269087|NCT02706938|BG000|Baseline|Head of Bed Elevation - Control|"Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269088|NCT02706938|BG001|Baseline|Control - Head of Bed Elevation|"Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269089|NCT02706938|BG002|Baseline|Total|Total of all reporting groups
11269090|NCT02706938|FG000|Participant Flow|Head of Bed Elevation - Control|"Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269091|NCT02706938|FG001|Participant Flow|Control - Head of Bed Elevation|"Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269092|NCT02706938|OG000|Outcome|Head of Bed Elevation|"Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269093|NCT02706938|OG001|Outcome|Control|"Participants will sleep in a bed without inclination during a first period of 6 weeks.~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269094|NCT02706938|OG000|Outcome|All Participants|All participants who used both head of bed elevation and control interventions, regardless they did not complete the entire trial or did not retrieve all the questionnaires.
11269095|NCT02706938|EG000|Reported Event|Head of Bed Elevation|"Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.~Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269096|NCT02706938|EG001|Reported Event|Control|"Participants will sleep in a bed without inclination during a first period of 6 weeks.~Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement."
11269097|NCT02706951|BG000|Baseline|Methotrexate|Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.
11269098|NCT02706951|BG001|Baseline|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269099|NCT02706951|BG002|Baseline|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269100|NCT02706951|BG003|Baseline|Total|Total of all reporting groups
11269101|NCT02706951|FG000|Participant Flow|Methotrexate|Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily (QD) for 14 weeks in Period 1.
11269102|NCT02706951|FG001|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269103|NCT02706951|FG002|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269104|NCT02706951|OG000|Outcome|Methotrexate|Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.
11269105|NCT02706951|OG001|Outcome|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269106|NCT02706951|OG002|Outcome|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269107|NCT02706951|EG000|Reported Event|Methotrexate|Participants received up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1
11269108|NCT02706951|EG001|Reported Event|Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269109|NCT02706951|EG002|Reported Event|Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.
11269110|NCT02707146|BG000|Baseline|Tablet in the Waiting Room|"Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the Visit Planner tool application on the tablet~Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit~iPad"
11269111|NCT02707146|BG001|Baseline|Health Education Handout|"Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review~Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle"
11269112|NCT02707146|BG002|Baseline|Total|Total of all reporting groups
11269113|NCT02707146|FG000|Participant Flow|Tablet in the Waiting Room|"Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the Visit Planner tool application on the tablet~Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit~iPad"
11269114|NCT02707146|FG001|Participant Flow|Health Education Handout|"Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review~Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle"
11269115|NCT02707146|OG000|Outcome|Tablet in the Waiting Room|"Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the Visit Planner tool application on the tablet~Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit~iPad"
11269116|NCT02707146|OG001|Outcome|Health Education Handout|"Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review~Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle"
11269117|NCT02707146|EG000|Reported Event|Tablet in the Waiting Room|"Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the Visit Planner tool application on the tablet~Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit~iPad"
11269118|NCT02707146|EG001|Reported Event|Health Education Handout|"Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review~Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle"
11269119|NCT02707172|BG000|Baseline|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
10970153|NCT00909155|OG000|Outcome|Depressed; Venlafaxine Treatment|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months.~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.~12 subjects completed the treatment, and both the 2month and 6month fMRI scans."
10970154|NCT00909155|OG001|Outcome|Depressed; Fluoxetine Treatment|"Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months.~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d.~9 subjects completed the treatment, and both the 2month and 6month fMRI scans."
11214428|NCT02291861|EG000|Reported Event|Placebo|Placebo tablets taken twice daily for 12 weeks.
11214429|NCT02291861|EG001|Reported Event|SD-809 12 mg/Day|SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
11214430|NCT02291861|EG002|Reported Event|SD-809 24 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
11214431|NCT02291861|EG003|Reported Event|SD-809 36 mg/Day|SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
11214432|NCT02291913|BG000|Baseline|Everolimus|"Everolimus will be administered at a dose of 10 mg by mouth daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. A treatment cycle was defined as 4 weeks, with radiological evaluations every 8 weeks.~Everolimus~Exemestane: Anti-estrogen therapy~Tamoxifen: Anti-estrogen therapy~Fulvestrant: Anti-estrogen therapy~Anastrozole: Anti-estrogen therapy~Letrozole: Anti-estrogen therapy~Toremifine: Anti-estrogen therapy"
11214433|NCT02291913|FG000|Participant Flow|Everolimus|"Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.~Everolimus~Exemestane: Anti-estrogen therapy~Tamoxifen: Anti-estrogen therapy~Fulvestrant: Anti-estrogen therapy~Anastrozole: Anti-estrogen therapy~Letrozole: Anti-estrogen therapy~Toremifine: Anti-estrogen therapy"
11214434|NCT02291913|OG000|Outcome|Everolimus|"Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.~Everolimus~Exemestane: Anti-estrogen therapy~Tamoxifen: Anti-estrogen therapy~Fulvestrant: Anti-estrogen therapy~Anastrozole: Anti-estrogen therapy~Letrozole: Anti-estrogen therapy~Toremifine: Anti-estrogen therapy"
11214435|NCT02291913|EG000|Reported Event|Everolimus|"Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.~Everolimus~Exemestane: Anti-estrogen therapy~Tamoxifen: Anti-estrogen therapy~Fulvestrant: Anti-estrogen therapy~Anastrozole: Anti-estrogen therapy~Letrozole: Anti-estrogen therapy~Toremifine: Anti-estrogen therapy"
11214436|NCT02292082|BG000|Baseline|Peri-Articular Injections Only|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Surgeon will perform the periarticular injections:~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine~Intravenous sedation with midazolam and propofol.~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone"
11214437|NCT02292082|BG001|Baseline|Peri-Articular Injections and Adductor Canal Block|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Adductor canal block technique:~Supine position, after IV sedation~Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches~Femoral artery will be identified in the adductor canal deep to the Sartorius muscle~15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone~Local anesthetic will be delivered periarterial between 12 and 6 o'clock~Intravenous sedation with midazolam and propofol.~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 20 ml 0.25% bupivacaine~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone~8 MHz. Chiba needle, 22 G / 4 inches"
11214438|NCT02292082|BG002|Baseline|Total|Total of all reporting groups
11214439|NCT02292082|FG000|Participant Flow|Peri-Articular Injections Only|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Surgeon will perform the periarticular injections:~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine~Intravenous sedation with midazolam and propofol.~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone"
11269120|NCT02707172|FG000|Participant Flow|All Participants|"All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order.~28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment.~In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment.~A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study."
11269121|NCT02707172|OG000|Outcome|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
11269122|NCT02707172|EG000|Reported Event|Intervention|"Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique.~Then the subjects in this arms are crossover to receive placebo, handwashing with water only.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
11269123|NCT02707172|EG001|Reported Event|Placebo|"Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique.~Then the subjects in this arms are crossover to perform the intervention, handwashing with soap.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
11269124|NCT02707432|BG000|Baseline|Time 1 Heart Matters Intervention Group|"This group will receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269125|NCT02707432|BG001|Baseline|Time 2 Heart Matters 6 Month-Delayed Intervention Group|"This 6 month delayed intervention group will receive the adapted intervention, Heart Matters, six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269126|NCT02707432|BG002|Baseline|Total|Total of all reporting groups
11269127|NCT02707432|FG000|Participant Flow|Time 1 Heart Matters Intervention Group|"This group will receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269128|NCT02707432|FG001|Participant Flow|Time 2 Heart Matters 6 Month-Delayed Intervention Group|"This 6 month delayed intervention group will receive the adapted intervention, Heart Matters, six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269129|NCT02707432|OG000|Outcome|Time 1 Heart Matters Intervention Group|"This group will receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269130|NCT02707432|OG001|Outcome|Time 2 Heart Matters 6 Month-Delayed Intervention Group|"This 6 month delayed intervention group will receive the adapted intervention, Heart Matters, six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269131|NCT02707432|EG000|Reported Event|Time 1 Heart Matters Intervention Group|"This group will receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269132|NCT02707432|EG001|Reported Event|Time 2 Heart Matters 6 Month-Delayed Intervention Group|"This 6 month delayed intervention group will receive the adapted intervention, Heart Matters, six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period."
11269133|NCT02707523|BG000|Baseline|Control|Placebo controlled (normal saline) daily for 3 days
11269134|NCT02707523|BG001|Baseline|Azithromycin (10 mg/kg)|10 mg/kg IV Azithromycin daily for 3 days
11269135|NCT02707523|BG002|Baseline|Azithromycin (20 mg/kg)|20 mg/kg IV Azithromycin daily for 3 days
11269136|NCT02707523|BG003|Baseline|Total|Total of all reporting groups
11269137|NCT02707523|FG000|Participant Flow|Control|Placebo controlled (normal saline) daily for 3 days
11269138|NCT02707523|FG001|Participant Flow|Azithromycin (10 mg/kg)|10 mg/kg IV Azithromycin daily for 3 days
11269139|NCT02707523|FG002|Participant Flow|Azithromycin (20 mg/kg)|20 mg/kg IV Azithromycin daily for 3 days
11269140|NCT02707523|OG000|Outcome|Control|"Placebo controlled (normal saline) daily for 3 days~Placebo"
11269141|NCT02707523|OG001|Outcome|Azithromycin (10 mg/kg)|"10 mg/kg IV Azithromycin daily for 3 days~Azithromycin 10 mg"
11269142|NCT02707523|OG002|Outcome|Azithromycin (20 mg/kg)|"20 mg/kg IV Azithromycin daily for 3 days~Azithromycin 20mg"
11269143|NCT02707523|EG000|Reported Event|Control|"Placebo controlled (normal saline) daily for 3 days~Placebo"
11269144|NCT02707523|EG001|Reported Event|Azithromycin (10 mg/kg)|"10 mg/kg IV Azithromycin daily for 3 days~Azithromycin 10 mg"
11269145|NCT02707523|EG002|Reported Event|Azithromycin (20 mg/kg)|"20 mg/kg IV Azithromycin daily for 3 days~Azithromycin 20mg"
11269146|NCT02707601|BG000|Baseline|E/C/F/TAF + LDV/SOF|"Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269147|NCT02707601|BG001|Baseline|F/R/TAF + LDV/SOF|"Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269148|NCT02707601|BG002|Baseline|Total|Total of all reporting groups
11269149|NCT02707601|FG000|Participant Flow|E/C/F/TAF + LDV/SOF|"Part 1: Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269150|NCT02707601|FG001|Participant Flow|F/R/TAF + LDV/SOF|"Part 1: Participants received emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269151|NCT02707601|OG000|Outcome|E/C/F/TAF + LDV/SOF|"Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269152|NCT02707601|OG001|Outcome|F/R/TAF + LDV/SOF|"Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269153|NCT02707601|OG000|Outcome|E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)|In Part 2 of the study, participants from part 1 continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
11269154|NCT02707601|OG001|Outcome|F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)|In Part 2 of the study, participants from part 1 continued receiving (F/R/TAF) 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
11269155|NCT02707601|OG002|Outcome|E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12)|"Part 1: Participants received E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food for 8 weeks.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269156|NCT02707601|OG003|Outcome|F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12)|"Part 1: Participants received F/R/TAF 200/25/25 mg tablet orally once daily with food for 8 weeks.~Part 2: Participants continued receiving (F/R/TAF) 200/25/25 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269157|NCT02707601|EG000|Reported Event|E/C/F/TAF + LDV/SOF|"Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269158|NCT02707601|EG001|Reported Event|F/R/TAF + LDV/SOF|"Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20)."
11269159|NCT02707640|BG000|Baseline|N-Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269160|NCT02707640|BG001|Baseline|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269161|NCT02707640|BG002|Baseline|Total|Total of all reporting groups
11269162|NCT02707640|FG000|Participant Flow|N-Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
10847297|NCT00282672|OG002|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|Crossed over to HGD: Radiofrequency
10847298|NCT00282672|OG003|Outcome|HGD Radiofrequency Ablation|
11269163|NCT02707640|FG001|Participant Flow|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269164|NCT02707640|OG000|Outcome|N-Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269165|NCT02707640|OG001|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269166|NCT02707640|EG000|Reported Event|N-Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269167|NCT02707640|EG001|Reported Event|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
11269168|NCT02707757|BG000|Baseline|Iron Sucrose|"Iron sucrose 200mg for 5 doses~Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"
11269169|NCT02707757|BG001|Baseline|Neorecormon|"Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000~Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria"
11269170|NCT02707757|BG002|Baseline|Total|Total of all reporting groups
11092265|NCT01538628|FG000|Participant Flow|SpaceOAR|"Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel~SpaceOAR System: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel."
11269171|NCT02707757|FG000|Participant Flow|Iron Sucrose|"Iron sucrose 200mg for 5 doses~Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"
11269172|NCT02707757|FG001|Participant Flow|Neorecormon|"Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000~Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria"
11269173|NCT02707757|OG000|Outcome|Iron Sucrose|"Iron sucrose 200mg for 5 doses~Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"
11269174|NCT02707757|OG001|Outcome|Neorecormon|"Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000~Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria"
11269175|NCT02707757|EG000|Reported Event|Iron Sucrose|"Iron sucrose 200mg for 5 doses~Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"
11269176|NCT02707757|EG001|Reported Event|Neorecormon|"Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000~Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria"
11269177|NCT02707770|BG000|Baseline|Ambulatory Oxygen|Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)
10847299|NCT00282672|OG000|Outcome|All LGD Patients|LGD: Sham procedure group crossed over to LGD: Radiofrequency group at 12 month
11269178|NCT02707770|BG001|Baseline|Room Air|Patient will breath on room air during pulmonary rehabilitation programme
11269179|NCT02707770|BG002|Baseline|Total|Total of all reporting groups
11269180|NCT02707770|FG000|Participant Flow|Ambulatory Oxygen|"Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)~Pulmonary Rehabilitation"
11269181|NCT02707770|FG001|Participant Flow|Room Air|"Patient will breath on room air during pulmonary rehabilitation programme~Pulmonary Rehabilitation"
11269182|NCT02707770|OG000|Outcome|Ambulatory Oxygen|"Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)~Pulmonary Rehabilitation"
11269183|NCT02707770|OG001|Outcome|Room Air|"Patient will breath on room air during pulmonary rehabilitation programme~Pulmonary Rehabilitation"
11269184|NCT02707770|OG000|Outcome|Ambulatory Oxygen|Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)
11269185|NCT02707770|OG001|Outcome|Room Air|Patient will breath on room air during pulmonary rehabilitation programme
11269186|NCT02707770|EG000|Reported Event|Ambulatory Oxygen|Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)
11269187|NCT02707770|EG001|Reported Event|Room Air|Patient will breath on room air during pulmonary rehabilitation programme
11337575|NCT03587974|FG000|Participant Flow|REACH-VN|"In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months~REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease"
11337576|NCT03587974|FG001|Participant Flow|Enhanced Control|Single session with education about nature of dementia
11269188|NCT02707861|BG000|Baseline|Cohort 1|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~OR~2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269189|NCT02707861|BG001|Baseline|Cohort 2|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for qualifying patients who have never received ibalizumab~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269190|NCT02707861|BG002|Baseline|Total|Total of all reporting groups
11269191|NCT02707861|FG000|Participant Flow|Cohort 1|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~OR~2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269192|NCT02707861|FG001|Participant Flow|Cohort 2|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for qualifying patients who have never received ibalizumab~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269193|NCT02707861|OG000|Outcome|Cohort 1|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~OR~2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269194|NCT02707861|OG001|Outcome|Cohort 2|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for qualifying patients who have never received ibalizumab~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269195|NCT02707861|EG000|Reported Event|Cohort 1|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~OR~2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269196|NCT02707861|EG001|Reported Event|Cohort 2|"IV ibalizumab (combined with optimized background regimen):~800 mg once every two weeks for qualifying patients who have never received ibalizumab~Administered for 48 weeks, or until ibalizumab becomes commercially available~ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry~Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible)."
11269197|NCT02707952|BG000|Baseline|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.
11269198|NCT02707952|BG001|Baseline|Arm B|Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
11269199|NCT02707952|BG002|Baseline|Arm C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
11269200|NCT02707952|BG003|Baseline|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
11269201|NCT02707952|BG004|Baseline|Total|Total of all reporting groups
11269202|NCT02707952|FG000|Participant Flow|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.
11269203|NCT02707952|FG001|Participant Flow|Arm B|Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
11269204|NCT02707952|FG002|Participant Flow|Arm C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
11269205|NCT02707952|FG003|Participant Flow|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
11269206|NCT02707952|OG000|Outcome|Arm A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.
11269207|NCT02707952|OG001|Outcome|Arm B|Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
11269208|NCT02707952|OG000|Outcome|Arm C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
11269209|NCT02707952|OG001|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
11269210|NCT02707952|OG002|Outcome|Arm C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
11269211|NCT02707952|OG003|Outcome|Arm D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
11269212|NCT02707952|EG000|Reported Event|ARM A|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.
11269213|NCT02707952|EG001|Reported Event|ARM B|Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
11269214|NCT02707952|EG002|Reported Event|ARM C|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
11269215|NCT02707952|EG003|Reported Event|ARM D|ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
11269216|NCT02707965|BG000|Baseline|Topiramate Tablet Group|All subjects who received the Topiramate Tablet.
11269217|NCT02707965|BG001|Baseline|Lamotrigine IR Tablet Group|All subjects who received the Lamotrigine IR Tablet.
11269218|NCT02707965|BG002|Baseline|Lamotrigine ER Tablet Group|All subjects who received the Lamotrigine ER Tablet.
11269219|NCT02707965|BG003|Baseline|Levetiracetam IR Tablet Group|All subjects who received the Levetiracetam IR Tablet.
11269220|NCT02707965|BG004|Baseline|Levetiracetam ER Tablet Group|All subjects who received the Levetiracetam ER Tablet.
11269221|NCT02707965|BG005|Baseline|Carbamazepine ER Capsule|All subjects who received the Carbamazepine ER Capsule.
11269222|NCT02707965|BG006|Baseline|Carbamazepine ER Tablet|All subjects who received the Carbamazepine ER Tablet.
11269223|NCT02707965|BG007|Baseline|Zonisamide Capsule Group|All subjects who received the Zonisamide Capsule.
11269224|NCT02707965|BG008|Baseline|Valproic Acid ER Tablet Group|All subjects who received the Valproic Acid ER Tablet.
11269225|NCT02707965|BG009|Baseline|Total|Total of all reporting groups
11269226|NCT02707965|FG000|Participant Flow|Sequence 1/Topiramate|"Subjects received Topiramate in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269227|NCT02707965|FG001|Participant Flow|Sequence 2/Topiramate|"Subjects received Topiramate in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269228|NCT02707965|FG002|Participant Flow|Sequence 1/Lamotrigine|"Subjects received Lamotrigine in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269229|NCT02707965|FG003|Participant Flow|Sequence 2/Lamotrigine|"Subjects received Lamotrigine in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269230|NCT02707965|FG004|Participant Flow|Sequence 1/Levetiracetam IR|"Subjects received Levetiracetam IR in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269231|NCT02707965|FG005|Participant Flow|Sequence 2/Levetiracetam IR|"Subjects received Levetiracetam IR in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269232|NCT02707965|FG006|Participant Flow|Sequence 1/Carbamazepine ER Tablet|"Subjects received Carbamazepine ER tablet in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269233|NCT02707965|FG007|Participant Flow|Sequence 2/Carbamazepine ER Tablet|"Subjects received Carbamazepine ER tablet in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269234|NCT02707965|FG008|Participant Flow|Sequence 1/Carbamazepine ER Capsule|"Subjects received Carbamazepine ER capsule in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269235|NCT02707965|FG009|Participant Flow|Sequence 2/Carbamazepine ER Capsule|"Subjects received Carbamazepine ER capsule in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269236|NCT02707965|FG010|Participant Flow|Sequence 1/Zonisamide|"Subjects received Zonisamide in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269237|NCT02707965|FG011|Participant Flow|Sequence 2/Zonisamide|"Subjects received Zonisamide in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269238|NCT02707965|FG012|Participant Flow|Sequence 1/Levetiracetam ER|"Subjects received Levetiracetam in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269239|NCT02707965|FG013|Participant Flow|Sequence 2/Levetiracetam ER|"Subjects received Levetiracetam ER in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269240|NCT02707965|FG014|Participant Flow|Sequence 1/Valproic Acid|"Subjects received Valproic acid in the sequence order 1 (TRRT).~Test-Reference-Reference-Test~Reference: Brand Test: Generic"
11269241|NCT02707965|FG015|Participant Flow|Sequence 2/Valproic Acid|"Subjects received Valproic acid in the sequence order 2 (RTTR).~Reference-Test-Test-Reference~Reference: Brand Test: Generic"
11269242|NCT02707965|OG000|Outcome|Topiramate Tablet|Subjects who received Topiramate for Sequence 1 and 2.
11269243|NCT02707965|OG001|Outcome|Lamotrigine ER Tablet|Subjects who received Lamotrigine ER for Sequence 1 and 2.
11269244|NCT02707965|OG002|Outcome|Levetiracetam IR Tablet|Subjects who received Levetiracetam IR for Sequence 1 and 2.
11269245|NCT02707965|OG003|Outcome|Levetiracetam ER Tablet|Subjects who received Levetiracetam ER for Sequence 1 and 2.
11269246|NCT02707965|OG004|Outcome|Carbamazepine ER Capsule|Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
11269247|NCT02707965|OG005|Outcome|Carbamazepine ER Tablet|Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
11269248|NCT02707965|OG006|Outcome|Zonisamide Capsule|Subjects who received Zonisamide for Sequence 1 and 2.
11269249|NCT02707965|OG000|Outcome|Topiramate|Subjects who received Topiramate for Sequence 1 and 2.
11269250|NCT02707965|OG001|Outcome|Lamotrigine ER|Subjects who received Lamotrigine ER for Sequence 1 and 2.
11269251|NCT02707965|OG002|Outcome|Levetiracetam IR|Subjects who received Levetiracetam IR for Sequence 1 and 2.
11269252|NCT02707965|OG003|Outcome|Levetiracetam ER|Subjects who received Levetiracetam ER for Sequence 1 and 2.
11269253|NCT02707965|OG005|Outcome|Zonisamide|Subjects who received Zonisamide for Sequence 1 and 2.
11269254|NCT02707965|OG006|Outcome|Carbamazepine ER Tablet|Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
11269255|NCT02707965|OG007|Outcome|Valproic Acid|Subjects who received Valproic acid for Sequence 1 and 2.
11269256|NCT02707965|OG000|Outcome|Topiramate Tablet Group|All subjects who received the Topiramate Tablet.
11269257|NCT02707965|OG001|Outcome|Lamotrigine IR Tablet Group|All subjects who received the Lamotrigine IR Tablet.
11269258|NCT02707965|OG002|Outcome|Lamotrigine ER Tablet Group|All subjects who received the Lamotrigine ER Tablet.
11269259|NCT02707965|OG003|Outcome|Levetiracetam IR Tablet Group|All subjects who received the Levetiracetam IR Tablet.
11269260|NCT02707965|OG004|Outcome|Levetiracetam ER Tablet Group|All subjects who received the Levetiracetam ER Tablet.
11269261|NCT02707965|OG005|Outcome|Carbamazepine ER Capsule|All subjects who received the Carbamazepine ER Capsule.
11269262|NCT02707965|OG006|Outcome|Carbamazepine ER Tablet|All subjects who received the Carbamazepine ER Tablet.
11269263|NCT02707965|OG007|Outcome|Zonisamide Capsule Group|All subjects who received the Zonisamide Capsule.
11269264|NCT02707965|OG008|Outcome|Valproic Acid ER Tablet Group|All subjects who received the Valproic Acid ER Tablet.
11269265|NCT02707965|EG000|Reported Event|Topiramate|Subjects who received Topiramate for Sequence 1 and 2.
11269266|NCT02707965|EG001|Reported Event|Lamotrigine ER|Subjects who received Lamotrigine ER for Sequence 1 and 2.
11269267|NCT02707965|EG002|Reported Event|Levetiracetam IR|Subjects who received Levetiracetam IR for Sequence 1 and 2.
11269268|NCT02707965|EG003|Reported Event|Levetiracetam ER|Subjects who received Levetiracetam ER for Sequence 1 and 2.
11269269|NCT02707965|EG004|Reported Event|Carbamazepine ER Capsule|Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
11269270|NCT02707965|EG005|Reported Event|Zonisamide|Subjects who received Zonisamide for Sequence 1 and 2.
11269271|NCT02707965|EG006|Reported Event|Carbamazepine ER Tablet|Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
11269272|NCT02707965|EG007|Reported Event|Valproic Acid|Subjects who received Valproic acid for Sequence 1 and 2.
11269273|NCT02707991|BG000|Baseline|Enhanced Usual Care|Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
11269274|NCT02707991|BG001|Baseline|Nurse Case Management|"Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention~Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention."
11269275|NCT02707991|BG002|Baseline|Total|Total of all reporting groups
11269276|NCT02707991|FG000|Participant Flow|Enhanced Usual Care|Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
11269277|NCT02707991|FG001|Participant Flow|Nurse Case Management|"Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention~Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention."
11269278|NCT02707991|OG000|Outcome|Enhanced Usual Care|Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
11269279|NCT02707991|OG001|Outcome|Nurse Case Management|"Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention~Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention."
11269280|NCT02707991|EG000|Reported Event|Enhanced Usual Care|Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
11269281|NCT02707991|EG001|Reported Event|Nurse Case Management|"Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention~Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention."
11269282|NCT02708095|BG000|Baseline|Placebo|Participants received Placebo orally once daily (QD) for 24 weeks.
11269283|NCT02708095|BG001|Baseline|2 mg Baricitinib|Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
11269284|NCT02708095|BG002|Baseline|4 mg Baricitinib|Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
11269285|NCT02708095|BG003|Baseline|Total|Total of all reporting groups
11269286|NCT02708095|FG000|Participant Flow|Placebo|Participants received Placebo orally once daily (QD) for 24 weeks.
11269287|NCT02708095|FG001|Participant Flow|2 mg Baricitinib|Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
11269288|NCT02708095|FG002|Participant Flow|4 mg Baricitinib|Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
11269289|NCT02708095|OG000|Outcome|Placebo|Participants received Placebo orally once daily (QD) for 24 weeks.
11269290|NCT02708095|OG001|Outcome|2 mg Baricitinib|Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
11269291|NCT02708095|OG002|Outcome|4 mg Baricitinib|Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
11269292|NCT02708095|OG000|Outcome|2 mg Baricitinib|Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
11269293|NCT02708095|OG001|Outcome|4 mg Baricitinib|Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
11269294|NCT02708095|EG000|Reported Event|Placebo|Participants received Placebo orally once daily (QD) for 24 weeks.
11269295|NCT02708095|EG001|Reported Event|2 mg Baricitinib|Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
11269296|NCT02708095|EG002|Reported Event|4 mg Baricitinib|Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
11269297|NCT02708121|BG000|Baseline|Mobilization Tool Arm|"Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.~Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment."
11269298|NCT02708121|BG001|Baseline|Comparator Tool Arm|"Participant receives access to weight loss treatment alone.~Comparator Intervention: Participants informed that they have access to weight loss treatment."
11269299|NCT02708121|BG002|Baseline|Total|Total of all reporting groups
11269300|NCT02708121|FG000|Participant Flow|Mobilization Tool Arm|"Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.~Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment."
11269301|NCT02708121|FG001|Participant Flow|Comparator Tool Arm|"Participant receives access to weight loss treatment alone.~Comparator Intervention: Participants informed that they have access to weight loss treatment."
11269302|NCT02708121|OG000|Outcome|Mobilization Tool Arm|"Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.~Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment."
11269303|NCT02708121|OG001|Outcome|Comparator Tool Arm|"Participant receives access to weight loss treatment alone.~Comparator Intervention: Participants informed that they have access to weight loss treatment."
11269304|NCT02708121|EG000|Reported Event|Mobilization Tool Arm|"Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.~Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment."
11269305|NCT02708121|EG001|Reported Event|Comparator Tool Arm|"Participant receives access to weight loss treatment alone.~Comparator Intervention: Participants informed that they have access to weight loss treatment."
11269306|NCT02708186|BG000|Baseline|Nelotanserin|"Nelotanserin 80 mg~Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin."
11269307|NCT02708186|BG001|Baseline|Placebo|"Placebo~Placebo: once daily, oral, matching tablets"
11269308|NCT02708186|BG002|Baseline|Total|Total of all reporting groups
11269309|NCT02708186|FG000|Participant Flow|Nelotanserin|"Nelotanserin 80 mg~Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin."
11269310|NCT02708186|FG001|Participant Flow|Placebo|"Placebo~Placebo: once daily, oral, matching tablets"
11269311|NCT02708186|OG000|Outcome|Nelotanserin|"Nelotanserin 80 mg~Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin."
11269312|NCT02708186|OG001|Outcome|Placebo|"Placebo~Placebo: once daily, oral, matching tablets"
11092266|NCT01538628|FG001|Participant Flow|Control|Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.
11269313|NCT02708186|EG000|Reported Event|Nelotanserin|"Nelotanserin 80 mg~Nelotanserin: once daily, oral, 20-mg tablets"
11269314|NCT02708186|EG001|Reported Event|Placebo|"Placebo~Placebo: once daily, oral, matching tablets"
11269315|NCT02708212|BG000|Baseline|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
11269316|NCT02708212|BG001|Baseline|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
11269317|NCT02708212|BG002|Baseline|Total|Total of all reporting groups
11269318|NCT02708212|FG000|Participant Flow|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
11269319|NCT02708212|FG001|Participant Flow|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
11269320|NCT02708212|OG000|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
11269321|NCT02708212|OG001|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
11337577|NCT03587974|OG000|Outcome|REACH-VN|"In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months~REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease"
11092267|NCT01538628|OG000|Outcome|SpaceOAR|Subjects randomized to receive SpaceOAR hydrogel.
11269322|NCT02708212|OG000|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
11269323|NCT02708212|OG001|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
11269324|NCT02708212|OG000|Outcome|EGD-colonoscopy Group|The duration of both EGD and colonoscopy examinations was recorded and compared.
11269325|NCT02708212|OG001|Outcome|Colonoscopy-EGD Group|The duration of both colonoscopy and EGD examinations was recorded and compared.
11269326|NCT02708212|EG000|Reported Event|EGD-colonoscopy Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
11269327|NCT02708212|EG001|Reported Event|Colonoscopy-EGD Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
11269328|NCT02708238|BG000|Baseline|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
11269329|NCT02708238|BG001|Baseline|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
11269330|NCT02708238|BG002|Baseline|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
11269331|NCT02708238|BG003|Baseline|Total|Total of all reporting groups
11269332|NCT02708238|FG000|Participant Flow|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
11092268|NCT01538628|OG001|Outcome|Control|Subjects randomized to not receive SpaceOAR hydrogel.
11092269|NCT01538628|OG001|Outcome|Control|Subjects randomized to not receive SpaceOAR hydrogel
11269333|NCT02708238|FG001|Participant Flow|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
11269334|NCT02708238|FG002|Participant Flow|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
11269335|NCT02708238|OG000|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
11269336|NCT02708238|OG001|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
11269337|NCT02708238|OG002|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
11269338|NCT02708238|EG000|Reported Event|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
11269339|NCT02708238|EG001|Reported Event|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
11269340|NCT02708238|EG002|Reported Event|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
11337578|NCT03587974|OG001|Outcome|Enhanced Control|Single session with education about nature of dementia
11337579|NCT03587974|EG000|Reported Event|REACH-VN|"In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months~REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease"
11337580|NCT03587974|EG001|Reported Event|Enhanced Control|Single session with education about nature of dementia
11269341|NCT02708277|BG000|Baseline|Group A|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
11269342|NCT02708277|BG001|Baseline|Group B|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
11269343|NCT02708277|BG002|Baseline|Total|Total of all reporting groups
11269344|NCT02708277|FG000|Participant Flow|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
11269345|NCT02708277|FG001|Participant Flow|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
11269346|NCT02708277|OG000|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
11269347|NCT02708277|OG001|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
11269348|NCT02708277|EG000|Reported Event|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
11269349|NCT02708277|EG001|Reported Event|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
10847300|NCT00282672|OG001|Outcome|All HGD Patients|HGD: Sham procedure group crossed over to HGD: Radiofrequency group at 12 month
11269350|NCT02708290|BG000|Baseline|Test Arm|"The test group included participants who completed more than one thousand MITA exercises and made no more than one error per exercise.~MITA imagination exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time: Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store."
11269351|NCT02708290|BG001|Baseline|Control Arm|The control group included the rest of participants. The test group participants were matched to the control group by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health at the 1st evaluation.
11269352|NCT02708290|BG002|Baseline|Total|Total of all reporting groups
11269353|NCT02708290|FG000|Participant Flow|Test Arm: Completed More Than One Thousand Exercises|"The test group (assigned at the end of the three-year study) included participants who demonstrated engagement with the intervention by completing more than one thousand MITA exercises and making no more than one error per exercise.~MITA imagination exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time: Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store."
11269354|NCT02708290|FG001|Participant Flow|Control Arm: the Rest of Participants|The control group (assigned at the end of the three-year study) included the participants matched by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health score at the 1st evaluation to the test group participants. The participants that were not matched to the test group were not included into the comparison between the groups.
11269355|NCT02708290|OG000|Outcome|Test Arm|"The test group included participants who completed more than one thousand exercises and made no more than one error per exercise.~MITA imagination exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time: Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store."
11269356|NCT02708290|OG001|Outcome|Control Arm|The control group included the rest of participants. The test group participants were matched to the control group by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health at the 1st evaluation.
11269357|NCT02708290|EG000|Reported Event|Test Arm|"The test group included participants who completed more than one thousand exercises and made no more than one error per exercise.~MITA imagination exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time: Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store."
11269358|NCT02708290|EG001|Reported Event|Control Arm|The control group included the rest of participants. The test group participants were matched to the control group by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health at the 1st evaluation.
11269359|NCT02708355|BG000|Baseline|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
11269360|NCT02708355|BG001|Baseline|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
11269361|NCT02708355|BG002|Baseline|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
11269362|NCT02708355|BG003|Baseline|Total|Total of all reporting groups
11269363|NCT02708355|FG000|Participant Flow|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
11269364|NCT02708355|FG001|Participant Flow|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
11269365|NCT02708355|FG002|Participant Flow|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
11269366|NCT02708355|OG000|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
11269367|NCT02708355|OG001|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
11269368|NCT02708355|OG002|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
11269369|NCT02708355|EG000|Reported Event|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
11269370|NCT02708355|EG001|Reported Event|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
11269371|NCT02708355|EG002|Reported Event|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
11269372|NCT02708433|BG000|Baseline|All Participants|All participants who were randomized to received either Buffered 1% Lidocaine or Non-buffered 2% Lidocaine
11269373|NCT02708433|FG000|Participant Flow|Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine."
11269374|NCT02708433|FG001|Participant Flow|Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine."
11269375|NCT02708433|OG000|Outcome|Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine."
11269376|NCT02708433|OG001|Outcome|Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine."
11269377|NCT02708433|EG000|Reported Event|Buffered 1% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine."
11269378|NCT02708433|EG001|Reported Event|Non-Buffered 2% Lidocaine|"At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).~For this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine."
11269379|NCT02708485|BG000|Baseline|Control|The Sedentary group received no active treatment.
11269380|NCT02708485|BG001|Baseline|Physical Exercise|A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).
11269381|NCT02708485|BG002|Baseline|Total|Total of all reporting groups
11269382|NCT02708485|FG000|Participant Flow|Control Group|No intervention
11269383|NCT02708485|FG001|Participant Flow|Physical Exercise|"A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).~Physical exercise: A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale)."
11269384|NCT02708485|OG000|Outcome|Control|The Sedentary group received no active treatment.
11337581|NCT03588572|BG000|Baseline|Venlafaxine Group|"The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.~Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization"
11269385|NCT02708485|OG001|Outcome|Physical Exercise|"A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).~Physical exercise: A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale)."
11269386|NCT02708485|EG000|Reported Event|Control Group|No intervention
11269387|NCT02708485|EG001|Reported Event|Physical Exercise|"A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).~Physical exercise: A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale)."
11269388|NCT02708498|BG000|Baseline|Intervention Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269389|NCT02708498|BG001|Baseline|Control Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269390|NCT02708498|BG002|Baseline|Intervention Group Next-of-Kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269391|NCT02708498|BG003|Baseline|Control Group Next-of-kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269392|NCT02708498|BG004|Baseline|Intervention Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269393|NCT02708498|BG005|Baseline|Control Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269394|NCT02708498|BG006|Baseline|Intervention Group Managers|Managers: Managers at different levels with responsibility for the care and social service at the included nursing homes.
11269395|NCT02708498|BG007|Baseline|Intervention Focus Groups Staff|The focus groups took place at the intervention nursing homes and included 40 staff divided into six groups.
11269396|NCT02708498|BG008|Baseline|Total|Total of all reporting groups
11269397|NCT02708498|FG000|Participant Flow|Intervention Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269398|NCT02708498|FG001|Participant Flow|Control Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269399|NCT02708498|FG002|Participant Flow|Intervention Group Next-of-Kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269400|NCT02708498|FG003|Participant Flow|Control Group Next-of-kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269401|NCT02708498|FG004|Participant Flow|Intervention Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269402|NCT02708498|FG005|Participant Flow|Control Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269403|NCT02708498|FG006|Participant Flow|Intervention Group Managers|Managers: Managers at different levels with responsibility for the care and social service at the included nursing homes.
11269404|NCT02708498|FG007|Participant Flow|Intervention Focus Groups|The focus groups took place at the intervention nursing homes and included 48 staff divided into six groups.
11269405|NCT02708498|OG000|Outcome|Intervention Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269406|NCT02708498|OG001|Outcome|Control Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia and with enough energy to manage a structured interview during up to one hour.
11269407|NCT02708498|OG000|Outcome|Intervention Group Next-of-Kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269408|NCT02708498|OG001|Outcome|Control Group Next-of-kin|The next of kin: The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269409|NCT02708498|OG000|Outcome|Intervention Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269410|NCT02708498|OG001|Outcome|Control Group Staff|Staff: The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269411|NCT02708498|EG000|Reported Event|Intervention Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia, speaking Swedish and with enough energy to manage a structured interview during up to one hour.
11269412|NCT02708498|EG001|Reported Event|Control Group Older People|Older persons: The inclusion criteria for the older persons were ≥ 65 years without dementia, speaking Swedish and with enough energy to manage a structured interview during up to one hour.
11337582|NCT03588572|BG001|Baseline|Controlled Group|the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
11269413|NCT02708498|EG002|Reported Event|Intervention Group Next of Kin|The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269414|NCT02708498|EG003|Reported Event|Control Group Next of Kin|The inclusion criterion was someone who had a relation to one of the older persons living at the participating nursing homes but not necessarily family members or relatives.
11269415|NCT02708498|EG004|Reported Event|Intervention Group Staff|The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269416|NCT02708498|EG005|Reported Event|Control Group Staff|The inclusion criterion was staff at nursing homes (commonly assistant nurses, nurses, occupational therapists and physiotherapists).
11269417|NCT02708498|EG006|Reported Event|Intervention Group Managers|Managers at different levels with responsibility for the care and social service at the included nursing homes
11269418|NCT02708498|EG007|Reported Event|Intervention Focus Groups Staff|The focus groups took place at the intervention nursing homes and included 40 staff divided into six groups.
11269419|NCT02708524|BG000|Baseline|Senofilcon C|All subjects that wore the senofilcon C lens throughout the duration of the study.
11269420|NCT02708524|BG001|Baseline|Comfilcon A|All subjects that wore the comfilcon A lens throughout the duration of the study.
11269421|NCT02708524|BG002|Baseline|Lotrafilcon B|All subjects that wore the lotrafilcon B lens throughout the duration of the study.
11269422|NCT02708524|BG003|Baseline|Samfilcon A|All subjects that wore the samfilcon A lens throughout the duration of the study.
11269423|NCT02708524|BG004|Baseline|Total|Total of all reporting groups
11269424|NCT02708524|FG000|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11269425|NCT02708524|FG001|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11269426|NCT02708524|FG002|Participant Flow|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
11269427|NCT02708524|FG003|Participant Flow|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
11269428|NCT02708524|OG000|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11269429|NCT02708524|OG001|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11269430|NCT02708524|OG002|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
11269431|NCT02708524|OG003|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
11269432|NCT02708524|EG000|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
11269433|NCT02708524|EG001|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
11269434|NCT02708524|EG002|Reported Event|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
11269435|NCT02708524|EG003|Reported Event|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
11269436|NCT02708641|BG000|Baseline|Pembro 200 mg - AML Patients|Patients with AML (not transplantation eligible) treated with pembrolizumab 200 mg IV administered once every three weeks, post-remission
11269437|NCT02708641|FG000|Participant Flow|Pembro 200 mg - AML Patients|Patients with AML (not transplantation eligible) treated with pembrolizumab 200 mg IV administered once every three weeks, post-remission
11269438|NCT02708641|OG000|Outcome|Pembro 200 mg - AML Patients|Patients with AML (not transplantation eligible) treated with pembrolizumab 200 mg IV administered once every three weeks, post-remission.
11269439|NCT02708641|EG000|Reported Event|AML Patients|pembrolizumab 200 mg given IV once every three weeks
11269440|NCT02708745|BG000|Baseline|Placebo Arm|"Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.~Placebo Survey"
11269441|NCT02708745|BG001|Baseline|Intervention Arm|"Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.~Intervention Survey"
11269442|NCT02708745|BG002|Baseline|Pre-Intervention Providers|Providers at enrolled clinics who completed a survey before the parent-level intervention period
11269443|NCT02708745|BG003|Baseline|Post-Intervention Providers|Providers at enrolled clinics who completed a survey after the parent-level intervention period
11269444|NCT02708745|BG004|Baseline|Total|Total of all reporting groups
11269445|NCT02708745|FG000|Participant Flow|Placebo Arm|"Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.~Placebo Survey"
11269446|NCT02708745|FG001|Participant Flow|Intervention Arm|"Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.~Intervention Survey"
11269447|NCT02708745|FG002|Participant Flow|Pre-Intervention Providers|Providers at enrolled clinics who completed a survey before the parent-level intervention period
11269448|NCT02708745|FG003|Participant Flow|Post-Intervention Providers|Providers at enrolled clinics who completed a survey after the parent-level intervention period
11269449|NCT02708745|OG000|Outcome|Placebo Arm|"Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.~Placebo Survey"
11269450|NCT02708745|OG001|Outcome|Intervention Arm|"Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.~Intervention Survey"
11269451|NCT02708745|OG000|Outcome|Experimental|Parents in this arm received the intervention
11269452|NCT02708745|OG001|Outcome|Placebo|Parents in this arm did not receive the intervention
11269453|NCT02708745|OG000|Outcome|Pre-Intervention Providers|Providers rated the significance of the 3 barriers to the vaccine discussion before the parent-level intervention period
11337583|NCT03588572|BG002|Baseline|Total|Total of all reporting groups
11269454|NCT02708745|OG001|Outcome|Post-Intervention Providers|Providers rated the significance of the 3 barriers to the vaccine discussion after the parent-level intervention period
11269455|NCT02708745|EG000|Reported Event|Placebo Arm|"Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.~Placebo Survey"
11269456|NCT02708745|EG001|Reported Event|Intervention Arm|"Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.~Intervention Survey"
11269457|NCT02708745|EG002|Reported Event|Pre-Intervention Providers|Providers at enrolled clinics who completed a survey before the parent-level intervention period
11269458|NCT02708745|EG003|Reported Event|Post-Intervention Providers|Providers at enrolled clinics who completed a survey after the parent-level intervention period
11269459|NCT02708862|BG000|Baseline|Preoxygenation|All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
11269460|NCT02708862|FG000|Participant Flow|Preoxygenation|All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
11269461|NCT02708862|OG000|Outcome|Preoxygenation|All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
11269462|NCT02708862|EG000|Reported Event|Simple Mask|"Simple mask at 60 L/min for 3 minutes~Simple mask at 60 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured."
11269463|NCT02708862|EG001|Reported Event|Non-rebreather at 15 L/Min|"Non-rebreather at 60 L/min~Non-rebreather at 15 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured."
11269464|NCT02708862|EG002|Reported Event|Non-rebreather at 60 L/Min|"Non-rebreather at 60 L/min for 3 minutes~Non-rebreather at 60 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured."
11269465|NCT02708862|EG003|Reported Event|Bag Valve Mask at 15 L/Min|"Bag valve mask at 15 L/min for 3 minutes~Bag valve mask at 15 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured."
11269466|NCT02708966|BG000|Baseline|Gymnema Sylvestre|"Patients with IGT~Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269467|NCT02708966|BG001|Baseline|Placebo|"Patients with IGT~Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269468|NCT02708966|BG002|Baseline|Total|Total of all reporting groups
11269469|NCT02708966|FG000|Participant Flow|Gymnema Sylvestre|"Patients with impaired glucose tolerance (IGT)~Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269470|NCT02708966|FG001|Participant Flow|Placebo|"Patients with IGT~Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269471|NCT02708966|OG000|Outcome|Gymnema Sylvestre|"Patients with IGT~Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269472|NCT02708966|OG001|Outcome|Placebo|"Patients with IGT~Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269473|NCT02708966|EG000|Reported Event|Gymnema Sylvestre|"Patients with IGT~Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269474|NCT02708966|EG001|Reported Event|Placebo|"Patients with IGT~Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner"
11269475|NCT02709005|BG000|Baseline|5% Monolaurin Vaginal Gel|Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269476|NCT02709005|BG001|Baseline|Vehicle Placebo|The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269477|NCT02709005|BG002|Baseline|Total|Total of all reporting groups
11269478|NCT02709005|FG000|Participant Flow|5% Monolaurin Vaginal Gel|Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269479|NCT02709005|FG001|Participant Flow|Vehicle Placebo|The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269480|NCT02709005|OG000|Outcome|5% Monolaurin Vaginal Gel|Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269481|NCT02709005|OG001|Outcome|Vehicle Placebo|The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269482|NCT02709005|EG000|Reported Event|5% Monolaurin Vaginal Gel|Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269483|NCT02709005|EG001|Reported Event|Vehicle Placebo|The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
11269484|NCT02709018|BG000|Baseline|Losartan|"Losartan flexibly dosed from 25-100 mg per day over 10 weeks~losartan: Angiotensin receptor blocker (ARB)"
11269485|NCT02709018|BG001|Baseline|Placebo|"Placebo flexibly dosed from 25-100 mg per day over 10 weeks~Placebo: Placebo"
11269486|NCT02709018|BG002|Baseline|Total|Total of all reporting groups
11269487|NCT02709018|FG000|Participant Flow|Losartan|"Losartan flexibly dosed from 25-100 mg per day over 10 weeks~losartan: Angiotensin receptor blocker (ARB)"
11269488|NCT02709018|FG001|Participant Flow|Placebo|"Placebo flexibly dosed from 25-100 mg per day over 10 weeks~Placebo: Placebo"
11269489|NCT02709018|OG000|Outcome|Losartan|"Losartan flexibly dosed from 25-100 mg per day over 10 weeks~losartan: Angiotensin receptor blocker (ARB)"
11269490|NCT02709018|OG001|Outcome|Placebo|"Placebo flexibly dosed from 25-100 mg per day over 10 weeks~Placebo: Placebo"
11269491|NCT02709018|OG000|Outcome|CC Homozygotes on Losartan|CC Homozygotes on Losartan
11269492|NCT02709018|OG001|Outcome|T Carriers on Losartan|T Carriers on Losartan
11269493|NCT02709018|EG000|Reported Event|Losartan|"Losartan flexibly dosed from 25-100 mg per day over 10 weeks~losartan: Angiotensin receptor blocker (ARB)"
11269494|NCT02709018|EG001|Reported Event|Placebo|"Placebo flexibly dosed from 25-100 mg per day over 10 weeks~Placebo: Placebo"
11269495|NCT02709096|BG000|Baseline|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269496|NCT02709096|BG001|Baseline|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269497|NCT02709096|BG002|Baseline|Total|Total of all reporting groups
11269498|NCT02709096|FG000|Participant Flow|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269499|NCT02709096|FG001|Participant Flow|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269500|NCT02709096|OG000|Outcome|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269501|NCT02709096|OG001|Outcome|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269502|NCT02709096|EG000|Reported Event|BPX-01, 1% Topical Gel|"BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.~BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269503|NCT02709096|EG001|Reported Event|BPX-01, Vehicle Gel|"BPX-01, Vehicle Gel; applied once daily to the face for four weeks.~BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin"
11269504|NCT02709109|BG000|Baseline|Sequence 1: VX-371 + HS, Then HS|Participants received 85 mcg VX-371 diluted in 3 milliliter (mL) 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269505|NCT02709109|BG001|Baseline|Sequence 2: HS, Then VX-371 + HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269506|NCT02709109|BG002|Baseline|Sequence 3: VX-371 + Placebo, Then Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269507|NCT02709109|BG003|Baseline|Sequence 4: Placebo, Then VX-371 + Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269508|NCT02709109|BG004|Baseline|Total|Total of all reporting groups
11269509|NCT02709109|FG000|Participant Flow|Sequence 1: VX-371 + HS, Then HS|Participants received 85 microgram (mcg) VX-371 diluted in 3 milliliter (mL) 4.2 percent (%) HS through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 milligram (mg)/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their cystic fibrosis (CF) standard of care.
11269510|NCT02709109|FG001|Participant Flow|Sequence 2: HS, Then VX-371 + HS|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269511|NCT02709109|FG002|Participant Flow|Sequence 3: VX-371 + Placebo, Then Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269512|NCT02709109|FG003|Participant Flow|Sequence 4: Placebo, Then VX-371 + Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 1 to Day 28) in treatment period 1 followed by a 28 days washout period (Day 29 to Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (Day 57 to Day 84) in treatment period 2. Participants also received a stable dose of 2 tablets of Orkambi (lumacaftor 400 mg/ivacaftor 250 mg) orally every 12 hours with fat-containing food throughout the study as part of their CF standard of care.
11269513|NCT02709109|OG000|Outcome|VX-371 + Hypertonic Saline|Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269514|NCT02709109|OG001|Outcome|Hypertonic Saline|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269515|NCT02709109|OG002|Outcome|VX-371 + Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269516|NCT02709109|OG003|Outcome|Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269517|NCT02709109|OG001|Outcome|VX-371 + Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269518|NCT02709109|EG000|Reported Event|VX-371 + Hypertonic Saline|Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269519|NCT02709109|EG001|Reported Event|Hypertonic Saline|Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269520|NCT02709109|EG002|Reported Event|VX-371 + Placebo|Participants received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269521|NCT02709109|EG003|Reported Event|Placebo|Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
11269522|NCT02709330|BG000|Baseline|Lunasin Regimen|"The Lunasin regimen consists of:~LunaRich X Capsules (12 capsules per day)~Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)~Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)~It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.~Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage"
11269523|NCT02709330|FG000|Participant Flow|Lunasin Regimen|"The Lunasin regimen consists of:~LunaRich X Capsules (12 capsules per day)~Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)~Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)~It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.~Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage"
11269524|NCT02709330|FG001|Participant Flow|Control|Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group.
11269525|NCT02709330|OG000|Outcome|Lunasin Regimen|"The Lunasin regimen consists of:~LunaRich X Capsules (12 capsules per day)~Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)~Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)~It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.~Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage"
11269526|NCT02709330|OG001|Outcome|ALS Controls|Individuals with ALS who are not on Lunasin.
11269527|NCT02709330|OG002|Outcome|Healthy Controls|Healthy individuals who are not on Lunasin.
11269528|NCT02709330|EG000|Reported Event|Lunasin Regimen|"The Lunasin regimen consists of:~LunaRich X Capsules (12 capsules per day)~Reliv NOW - a mixture of 'vitamins, minerals and super-powered antioxidants' (3 scoops per day)~Pro-Vantage - a mixture of 'soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids' (2 scoops per day)~It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.~Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage"
10847301|NCT00282672|OG000|Outcome|All Groups|
10847302|NCT00282672|OG000|Outcome|All LGD Patients|
11269529|NCT02709369|BG000|Baseline|Active HIRREM|This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
11269530|NCT02709369|FG000|Participant Flow|Active HIRREM|This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
11269531|NCT02709369|OG000|Outcome|Active HIRREM|This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
11269532|NCT02709369|EG000|Reported Event|Active HIRREM|This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
11269533|NCT02709486|BG000|Baseline|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269534|NCT02709486|BG001|Baseline|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269535|NCT02709486|BG002|Baseline|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269536|NCT02709486|BG003|Baseline|Total|Total of all reporting groups
11269537|NCT02709486|FG000|Participant Flow|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269538|NCT02709486|FG001|Participant Flow|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269539|NCT02709486|FG002|Participant Flow|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269540|NCT02709486|OG000|Outcome|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269541|NCT02709486|OG001|Outcome|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269542|NCT02709486|OG002|Outcome|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269543|NCT02709486|EG000|Reported Event|Placebo|Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269544|NCT02709486|EG001|Reported Event|Tanezumab 2.5 mg|Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269545|NCT02709486|EG002|Reported Event|Tanezumab 5 mg|Tanezumab (RN624 or PF-04383119) 5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16.
11269546|NCT02709538|BG000|Baseline|GSP 301 NS|GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
11269547|NCT02709538|BG001|Baseline|GSP 301 Placebo NS pH 3.7|GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
11269548|NCT02709538|BG002|Baseline|GSP 301 Placebo NS pH 7.0|GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
11269549|NCT02709538|BG003|Baseline|Total|Total of all reporting groups
11269550|NCT02709538|FG000|Participant Flow|GSP 301 NS|GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
11269551|NCT02709538|FG001|Participant Flow|GSP 301 Placebo NS pH 3.7|GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
11269552|NCT02709538|FG002|Participant Flow|GSP 301 Placebo NS pH 7.0|GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
11269553|NCT02709538|OG000|Outcome|GSP 301 NS|GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
11269554|NCT02709538|OG001|Outcome|GSP 301 Placebo NS pH 3.7|GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
11269555|NCT02709538|OG002|Outcome|GSP 301 Placebo NS pH 7.0|GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
11269556|NCT02709538|EG000|Reported Event|GSP 301 NS|GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
11269557|NCT02709538|EG001|Reported Event|GSP 301 Placebo NS pH 3.7|GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
11269558|NCT02709538|EG002|Reported Event|GSP 301 Placebo NS pH 7.0|GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
11269559|NCT02709577|BG000|Baseline|EndoBarrier Gastrointestinal Liner|"Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.~EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum."
11269560|NCT02709577|BG001|Baseline|Sham: Endoscopy and Standard of Care|"Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.~Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes"
11269561|NCT02709577|BG002|Baseline|Total|Total of all reporting groups
11269562|NCT02709577|FG000|Participant Flow|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
11269563|NCT02709577|FG001|Participant Flow|Cohort B:EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
11269564|NCT02709577|FG002|Participant Flow|Cohort A Control Sham|Device was not implanted
11269565|NCT02709577|FG003|Participant Flow|Cohort B Control Sham|Device not implanted.
11269566|NCT02709577|OG000|Outcome|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
11269567|NCT02709577|OG001|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
11269568|NCT02709577|OG002|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
11269569|NCT02709577|OG003|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
11269570|NCT02709577|OG000|Outcome|Cohoart A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
11269571|NCT02709577|OG002|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was originally 6 months and then extended to 12 months based on physician discretion.
11269572|NCT02709577|OG003|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was 12 months.
11269573|NCT02709577|EG000|Reported Event|Cohorts A and B: EndoBarrier Gastrointestinal Liner|Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
11269574|NCT02709577|EG001|Reported Event|Cohorts A and B Sham: Endoscopy and Standard of Care|Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
11269575|NCT02709694|BG000|Baseline|Adult Subjects With Crohn's Disease|These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics >6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI.
11269576|NCT02709694|FG000|Participant Flow|Adult Subjects With Crohn's Disease|These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics >6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI.
11269577|NCT02709694|OG000|Outcome|Any Back Pain|Subjects with Crohn's Disease with back pain.
11269578|NCT02709694|OG001|Outcome|No Back Pain|Subjects with Crohn's disease without back pain.
11269579|NCT02709694|OG000|Outcome|Global MRI Positive|MRI showed evidence of sacroiliitis.
11269580|NCT02709694|OG001|Outcome|Global MRI Negative|MRI did not show evidence of sacroiliitis.
11269581|NCT02709694|OG000|Outcome|ASAS (Assessment of SpondyloArthritis International Society) MRI Positive|Subjects classified as having inflammatory back pain for meeting 4 out of the 5 following back pain parameters: onset of symptoms <40 years of age, insidious onset of pain, nocturnal pain, improvement with exercise and no improvement with rest.
11269582|NCT02709694|OG001|Outcome|ASAS (Assessment of SpondyloArthritis International Society) MRI Negative|Subjects not classified as having inflammatory back pain for meeting 4 out of the 5 following back pain parameters: onset of symptoms <40 years of age, insidious onset of pain, nocturnal pain, improvement with exercise and no improvement with rest.
11269583|NCT02709694|OG000|Outcome|Bone Marrow Edema|Type of lesion seen in MRI.
11269584|NCT02709694|OG001|Outcome|Erosion|Type of structural lesion seen in MRI.
11269585|NCT02709694|OG002|Outcome|Fat Metaplasia|Type of structural lesion seen in MRI.
11269586|NCT02709694|OG003|Outcome|Backfill|Type of structural lesion seen in MRI.
11269587|NCT02709694|OG004|Outcome|Ankylosis|Type of structural lesion seen in MRI.
11269588|NCT02709694|EG000|Reported Event|Adult Subjects With Crohn's Disease|These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics >6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI.
11269589|NCT02709746|BG000|Baseline|Single-blind Treatment (SBT), Placebo|Single-blind treatment, Placebo (encapsulated, orally) and Brief Psychosocial Intervention (BPI) for 4 weeks
11269590|NCT02709746|BG001|Baseline|DBT, Vortioxetine 10 mg|"Eligible patients from SBT period (patients with incomplete improvement), will be randomly assigned (1:1:1:1) double-blind treatment in DBT Period, 8 weeks.~Vortioxetine 10 mg/day, encapsulated tablets, orally."
11269591|NCT02709746|BG002|Baseline|DBT, Vortioxetine 20 mg|"Eligible patients from SBT period (patients with incomplete improvement), will be randomly assigned (1:1:1:1) double-blind treatment in DBT Period, 8 weeks.~Vortioxetine 20 mg/day, encapsulated tablets, orally."
11269592|NCT02709746|BG003|Baseline|DBT, Fluoxetine 20 mg|"Eligible patients from SBT period (patients with incomplete improvement), will be randomly assigned (1:1:1:1) double-blind treatment in DBT Period, 8 weeks.~Fluoxetine 20 mg/day, encapsulated tablets, orally."
11269593|NCT02709746|BG004|Baseline|DBT, Placebo|"Eligible patients from SBT period (patients with incomplete improvement), will be randomly assigned (1:1:1:1) double-blind treatment in DBT Period, 8 weeks.~Placebo, encapsulated tablets, orally."
11269594|NCT02709746|BG005|Baseline|Total|Total of all reporting groups
11269595|NCT02709746|FG000|Participant Flow|Single-blind Treatment, Placebo|Placebo, encapsulated, orally
11269596|NCT02709746|FG001|Participant Flow|DBT, Vortioxetine 10 mg|Vortioxetine 10 mg/day: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269597|NCT02709746|FG002|Participant Flow|DBT, Vortioxetine 20 mg|Vortioxetine 20 mg/day: 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269598|NCT02709746|FG003|Participant Flow|DBT, Fluoxetine 20 mg|Fluoxetine 20 mg/day: 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
11269599|NCT02709746|FG004|Participant Flow|DBT, Placebo|Placebo, encapsulated, orally
11269600|NCT02709746|OG000|Outcome|Vortioxetine 10 mg/Day|Vortioxetine 10 mg/day: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269601|NCT02709746|OG001|Outcome|Vortioxetine 20 mg/Day|Vortioxetine 20 mg/day: 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269602|NCT02709746|OG002|Outcome|Fluoxetine 20 mg/Day,|Fluoxetine 20 mg/day: 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
11269603|NCT02709746|OG003|Outcome|Placebo|Placebo: Encapsulated tablet
11269604|NCT02709746|OG004|Outcome|Vortioxetine Average (Avg. VOR)|"patients are randomized to one of four treatments.~Avg.- VOR is a calculation based on the treatment estimates from VOR 10 mg and VOR 20 mg."
11269605|NCT02709746|EG000|Reported Event|SBT, Placebo|Patients not randomized to DBT period
11269606|NCT02709746|EG001|Reported Event|DBT, Vortioxetine 10 mg|Vortioxetine 10 mg/day: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269607|NCT02709746|EG002|Reported Event|DBT, Vortioxetine 20 mg|Vortioxetine 20 mg/day: 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
11269608|NCT02709746|EG003|Reported Event|DBT, Fluoxetine 20 mg|Vortioxetine 20 mg/day: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
11269609|NCT02709746|EG004|Reported Event|DBT, Placebo|Placebo, encapsulated tablet, orally
11269610|NCT02709785|BG000|Baseline|Group 1 SmartMouth|"24 subjects with plaque and gingival inflammation~SmartMouth Clinical DDS Advanced Oral Rinse"
11269611|NCT02709785|BG001|Baseline|Group 2 Chlorhexidine|"28 subjects with plaque and gingival inflammation~0.12% chlorhexidine rinse"
11269612|NCT02709785|BG002|Baseline|Group 3 Placebo|"28 subjects with plaque and gingival inflammation~Placebo rinse"
11269613|NCT02709785|BG003|Baseline|Total|Total of all reporting groups
11269614|NCT02709785|FG000|Participant Flow|Group 1 SmartMouth|"24 subjects with plaque and gingival inflammation~SmartMouth Clinical DDS Advanced Oral Rinse"
11269615|NCT02709785|FG001|Participant Flow|Group 2 Chlorhexidine|"28 subjects with plaque and gingival inflammation~0.12% chlorhexidine rinse"
11269616|NCT02709785|FG002|Participant Flow|Group 3 Placebo|"28 subjects with plaque and gingival inflammation~Placebo rinse"
11269617|NCT02709785|OG000|Outcome|Group 1 SmartMouth|"23 subjects with plaque and gingival inflammation~SmartMouth Clinical DDS Advanced Oral Rinse"
11269618|NCT02709785|OG001|Outcome|Group 2 Chlorhexidine|"26 subjects with plaque and gingival inflammation~0.12% chlorhexidine rinse"
11269619|NCT02709785|OG002|Outcome|Group 3 Placebo|"27 subjects with plaque and gingival inflammation~Placebo rinse"
11269620|NCT02709785|EG000|Reported Event|Group 1 SmartMouth|"24 subjects with plaque and gingival inflammation~SmartMouth Clinical DDS Advanced Oral Rinse"
11269621|NCT02709785|EG001|Reported Event|Group 2 Chlorhexidine|"28 subjects with plaque and gingival inflammation~0.12% chlorhexidine rinse"
10847303|NCT00282672|OG001|Outcome|All HGD Patients|
11269622|NCT02709785|EG002|Reported Event|Group 3 Placebo|"28 subjects with plaque and gingival inflammation~Placebo rinse"
11269623|NCT02709889|BG000|Baseline|Large Cell Neuroendocrine Carcinoma|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269624|NCT02709889|BG001|Baseline|Neuroendocrine Prostate Cancer|Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269625|NCT02709889|BG002|Baseline|Gastroenteropancreatic Neuroendocrine Carcinoma|Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269626|NCT02709889|BG003|Baseline|Other Neuroendocrine Carcinoma|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269627|NCT02709889|BG004|Baseline|Malignant Melanoma|Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269628|NCT02709889|BG005|Baseline|Medullary Thyroid Cancer|Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269629|NCT02709889|BG006|Baseline|Glioblastoma|Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269630|NCT02709889|BG007|Baseline|Other Solid Tumors|Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269631|NCT02709889|BG008|Baseline|Total|Total of all reporting groups
11269632|NCT02709889|FG000|Participant Flow|Part A: Rovalpituzumab Tesirine 0.2 mg/kg|Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269633|NCT02709889|FG001|Participant Flow|Part A: Rovalpituzumab Tesirine 0.3 mg/kg|Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269634|NCT02709889|FG002|Participant Flow|Part A: Rovalpituzumab Tesirine 0.4 mg/kg|Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269635|NCT02709889|FG003|Participant Flow|Part B: Rovalpituzumab Tesirine 0.3 mg/kg|Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
10970155|NCT00909155|OG002|Outcome|Control|"Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication.~Control subjects did not complete the 2month and 6month fMRI scans since no depression was present, no treatment given, and no change in mood state expected.~As such, no change in depression score could be calculated to provide a comparable measure in this group analysis. This analysis looked for functional imaging findings that correlated with improvement in depression symptoms."
11269636|NCT02709889|OG000|Outcome|NEC: 0.2 mg/kg|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269637|NCT02709889|OG001|Outcome|NEC: 0.3 mg/kg|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269638|NCT02709889|OG002|Outcome|NEC: 0.4 mg/kg|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269639|NCT02709889|OG003|Outcome|NEC: Any Dose|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269640|NCT02709889|OG004|Outcome|Non-NEC: 0.2 mg/kg|Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269641|NCT02709889|OG005|Outcome|Non-NEC: 0.3 mg/kg|Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269642|NCT02709889|OG006|Outcome|Non-NEC: 0.4 mg/kg|Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11092270|NCT01538628|EG000|Reported Event|SpaceOAR|Subjects randomized to receive SpaceOAR hydrogel.
11092271|NCT01538628|EG001|Reported Event|Control|Subjects randomized to not receive SpaceOAR hydrogel.
11092272|NCT01538719|BG000|Baseline|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
11269643|NCT02709889|OG007|Outcome|Non-NEC: Any Dose|Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269644|NCT02709889|OG000|Outcome|Large Cell Neuroendocrine Carcinoma|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269645|NCT02709889|OG001|Outcome|Neuroendocrine Prostate Cancer|Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269646|NCT02709889|OG002|Outcome|Gastroenteropancreatic Neuroendocrine Carcinoma|Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269647|NCT02709889|OG003|Outcome|Other Neuroendocrine Carcinoma|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269648|NCT02709889|OG004|Outcome|Malignant Melanoma|Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269649|NCT02709889|OG005|Outcome|Medullary Thyroid Cancer|Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269650|NCT02709889|OG006|Outcome|Glioblastoma|Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269651|NCT02709889|OG007|Outcome|Other Solid Tumors|Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269652|NCT02709889|OG003|Outcome|Other Neuroendocrine Carcinoma|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269653|NCT02709889|OG006|Outcome|Glioblastoma|Participants with glioblastoma (GBM) who received rovalpituzumab rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269654|NCT02709889|OG000|Outcome|0.2 mg/kg|Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269655|NCT02709889|OG001|Outcome|0.3 mg/kg|Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269656|NCT02709889|OG002|Outcome|0.4 mg/kg|Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269657|NCT02709889|EG000|Reported Event|0.2_mg_kg_(LCNEC)|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269658|NCT02709889|EG001|Reported Event|0.2_mg_kg_(NEPC)|Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269659|NCT02709889|EG002|Reported Event|0.2_mg_kg_(GEPNEC)|"Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle.~Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle."
11269660|NCT02709889|EG003|Reported Event|0.2_mg_kg_(Other_NEC)|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269661|NCT02709889|EG004|Reported Event|0.2_mg_kg_(MM)|Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269662|NCT02709889|EG005|Reported Event|0.2_mg_kg_(MTC)|Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269663|NCT02709889|EG006|Reported Event|0.2_mg_kg_(GBM)|Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
10847304|NCT00282672|OG000|Outcome|LGD Radiofrequency Ablation|
11269664|NCT02709889|EG007|Reported Event|0.2_mg_kg_(Other_Solid)|Participants with other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269665|NCT02709889|EG008|Reported Event|0.3_mg_kg_(LCNEC)|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269666|NCT02709889|EG009|Reported Event|0.3_mg_kg_(NEPC)|Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269667|NCT02709889|EG010|Reported Event|0.3_mg_kg_(GEPNEC)|"Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle.~Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle."
11269668|NCT02709889|EG011|Reported Event|0.3_mg_kg_(Other_NEC)|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269669|NCT02709889|EG012|Reported Event|0.3_mg_kg_(MM)|Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269670|NCT02709889|EG013|Reported Event|0.3_mg_kg_(MTC)|Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269671|NCT02709889|EG014|Reported Event|0.3_mg_kg_(GBM)|Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269672|NCT02709889|EG015|Reported Event|0.3_mg_kg_(Other_Solid)|Participants with other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269673|NCT02709889|EG016|Reported Event|0.4_mg_kg_(GBM)|Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269674|NCT02709889|EG017|Reported Event|0.4_mg_kg_(GEPNEC)|"Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle.~Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle."
11269675|NCT02709889|EG018|Reported Event|0.4_mg_kg_(LCNEC)|Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269676|NCT02709889|EG019|Reported Event|0.4_mg_kg_(NEPC)|Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269677|NCT02709889|EG020|Reported Event|0.4_mg_kg_(Other_NEC)|Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269678|NCT02709889|EG021|Reported Event|0.4_mg_kg_(Other_Solid)|Participants with other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
11269679|NCT02710045|BG000|Baseline|MV at 9 Months|"All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.~At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269680|NCT02710045|BG001|Baseline|DTP + MV at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 old.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de"
11269681|NCT02710045|BG002|Baseline|DTP at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269682|NCT02710045|BG003|Baseline|Total|Total of all reporting groups
11269683|NCT02710045|FG000|Participant Flow|MV at 9 Months|"All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.~At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269684|NCT02710045|FG001|Participant Flow|DTP + MV at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de"
11269685|NCT02710045|FG002|Participant Flow|DTP at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269686|NCT02710045|OG000|Outcome|MV at 9 Months|"All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.~At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269687|NCT02710045|OG001|Outcome|DTP + MV at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.~Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de"
11269688|NCT02710045|OG002|Outcome|DTP at 9 Months|"DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.~Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age~Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age"
11269689|NCT02710045|EG000|Reported Event|MV Vaccination at 9 Months|Infants administered MV at 9 months of age
11269690|NCT02710045|EG001|Reported Event|DTP and MV Vaccination at 9 Months|Infants administered MV and DTP vaccines at 9 months of age
11269691|NCT02710045|EG002|Reported Event|DTP Vaccination at 9 Months|Infants administered DTP vaccine at 9 months of age
11269692|NCT02710071|BG000|Baseline|Placebo, Then Nebivolol, Then Hydrochlorothiazide|The participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
11092273|NCT01538719|BG001|Baseline|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
11092274|NCT01538719|BG002|Baseline|Total|Total of all reporting groups
11269693|NCT02710071|BG001|Baseline|Placebo, Then Hydrochlorothiazide, Then Nebivolol|The participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
11269694|NCT02710071|BG002|Baseline|Total|Total of all reporting groups
11269695|NCT02710071|FG000|Participant Flow|Placebo, Then Nebivolol, Then Hydrochlorothyazide|The participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
11269696|NCT02710071|FG001|Participant Flow|Placebo, Then Hydrochlorothiazide, Then Nebivolol|The participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
11269697|NCT02710071|OG000|Outcome|Placebo|Placebo for 2 weeks.
11269698|NCT02710071|OG001|Outcome|Nebivolol|Nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
11269699|NCT02710071|OG002|Outcome|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks.
11269700|NCT02710071|EG000|Reported Event|Placebo, Then Nebivolol, Then Hydrochlorothyazide|Participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
11269701|NCT02710071|EG001|Reported Event|Placebo, Then Hydrochlorothyazide, Then Nebivolol|Participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
11269702|NCT02710136|BG000|Baseline|Cockroach Sensitive Adults With Asthma|In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
11269703|NCT02710136|BG001|Baseline|Cockroach Sensitive Children With Asthma|In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
11269704|NCT02710136|BG002|Baseline|Total|Total of all reporting groups
11269705|NCT02710136|FG000|Participant Flow|Cockroach Sensitive Adults With Asthma|In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
11269706|NCT02710136|FG001|Participant Flow|Cockroach Sensitive Children With Asthma|In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
11269707|NCT02710136|OG000|Outcome|Cockroach Sensitive Adults With Asthma|In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
10847305|NCT00282672|OG001|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
10847306|NCT00282672|OG002|Outcome|HGD Radiofrequency Ablation|
11269708|NCT02710136|OG001|Outcome|Cockroach Sensitive Children With Asthma|In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
11269709|NCT02710136|EG000|Reported Event|Phase 1a Cockroach Sensitive Adults With Asthma|Adverse events captured during Screening and Phase 1a are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to return for a second nasal allergen challenge in Phase 1b to assess the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
11269710|NCT02710136|EG001|Reported Event|Phase 1b Cockroach Sensitive Adults With Asthma|Adverse events captured during Phase 1b are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
11269711|NCT02710136|EG002|Reported Event|Cockroach Sensitive Children With Asthma|Adverse events captured during Phase 2 are included. In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
11269712|NCT02710214|BG000|Baseline|Duavee|"1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks~Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks."
11269713|NCT02710214|BG001|Baseline|Placebo|"Placebo pill daily for 8 weeks.~Placebo: Once-daily dosing of placebo for 8 weeks"
11269714|NCT02710214|BG002|Baseline|Total|Total of all reporting groups
11269715|NCT02710214|FG000|Participant Flow|Duavee|"1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks~Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks."
11269716|NCT02710214|FG001|Participant Flow|Placebo|"Placebo pill daily for 8 weeks.~Placebo: Once-daily dosing of placebo for 8 weeks"
11269717|NCT02710214|OG000|Outcome|Duavee|"1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks~Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks."
11269718|NCT02710214|OG001|Outcome|Placebo|"Placebo pill daily for 8 weeks.~Placebo: Once-daily dosing of placebo for 8 weeks"
11269719|NCT02710214|EG000|Reported Event|Duavee|"1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks~Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks."
11269720|NCT02710214|EG001|Reported Event|Placebo|"Placebo pill daily for 8 weeks.~Placebo: Once-daily dosing of placebo for 8 weeks"
11269721|NCT02710240|BG000|Baseline|ICG Arm|Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
11269722|NCT02710240|FG000|Participant Flow|ICG Arm|Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
11269723|NCT02710240|OG000|Outcome|ICG Arm|Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
11269724|NCT02710240|EG000|Reported Event|ICG Arm|Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
11269725|NCT02710292|BG000|Baseline|Overall|Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11269726|NCT02710292|FG000|Participant Flow|DT1, Then TE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
11269727|NCT02710292|FG001|Participant Flow|TE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
11269728|NCT02710292|OG000|Outcome|Dailies Total1|Delefilcon A contact lenses worn bilaterally during Period 1 or Period 2 for for at least 7 days in a daily disposable modality.
11269729|NCT02710292|OG001|Outcome|TruEye|Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.
11269730|NCT02710292|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11269731|NCT02710292|EG001|Reported Event|Dailies Total1|All subjects exposed to delefilcon A contact lenses
11269732|NCT02710292|EG002|Reported Event|TruEye|All subjects exposed to narafilcon A contact lenses
11337584|NCT03588572|FG000|Participant Flow|Venlafaxine Group|"The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.~Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization"
11337585|NCT03588572|FG001|Participant Flow|Controlled Group|the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
11269733|NCT02710422|BG000|Baseline|Arm 1 - Amniotic Membrane Placement|"Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269734|NCT02710422|BG001|Baseline|Arm 2 - No Amniotic Membrane Placement|"Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269735|NCT02710422|BG002|Baseline|Total|Total of all reporting groups
11269736|NCT02710422|FG000|Participant Flow|Arm 1 - Amniotic Membrane Placement|"Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269737|NCT02710422|FG001|Participant Flow|Arm 2 - No Amniotic Membrane Placement|"Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269738|NCT02710422|OG000|Outcome|Arm 1 - Amniotic Membrane Placement|"Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269739|NCT02710422|OG001|Outcome|Arm 2 - No Amniotic Membrane Placement|"Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269740|NCT02710422|OG000|Outcome|Arm 1: Amniotic Membrane Placement|"Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269741|NCT02710422|OG001|Outcome|Arm 2: No Amniotic Membrane Placement|"Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11092275|NCT01538719|FG000|Participant Flow|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
11269742|NCT02710422|EG000|Reported Event|Arm 1 - Amniotic Membrane Placement|"Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269743|NCT02710422|EG001|Reported Event|Arm 2 - No Amniotic Membrane Placement|"Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.~EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.~PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.~SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals."
11269744|NCT02710526|BG000|Baseline|32 mg CAM2038 Weekly|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269745|NCT02710526|BG001|Baseline|128 mg CAM2038 Monthly Injection|"Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269746|NCT02710526|BG002|Baseline|160 mg CAM2038 Monthly Injection|"Group 3: 24 mg SL BPN for the first 7 days and then 160 mg of CAM2038 subcutaneous monthly injection in the buttocks starting on Day 8~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269747|NCT02710526|BG003|Baseline|Total|Total of all reporting groups
11269748|NCT02710526|FG000|Participant Flow|32 mg CAM2038 Weekly|"Group 1, 32 mg of CAM2038 subcutaneous weekly injections at multiple injection sites~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269749|NCT02710526|FG001|Participant Flow|128 mg CAM2038 Monthly Injection|"Group 2: 128 mg of CAM2038 subcutaneous monthly injections during Treatment Phase and 32 mg of CAM2038 subcutaneous weekly injections during Safety Extension in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269750|NCT02710526|FG002|Participant Flow|160 mg CAM2038 Monthly Injection|"Group 3: 24 mg SL BPN for the first 7 days and then 160 mg of CAM2038 subcutaneous monthly injections in the buttocks starting on Day 8~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269751|NCT02710526|OG000|Outcome|32 mg CAM2038 Weekly-Buttock|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269752|NCT02710526|OG001|Outcome|32 mg CAM2038 Weekly-Abdomen|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269753|NCT02710526|OG002|Outcome|32 mg CAM2038 Weekly-Thigh|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269754|NCT02710526|OG003|Outcome|32 mg CAM2038 Weekly-Upper Arm|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269755|NCT02710526|OG000|Outcome|128 mg CAM2038 Monthly Injection|"Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269756|NCT02710526|OG001|Outcome|160 mg CAM2038 Monthly Injection|"Group 3: 160 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269757|NCT02710526|OG002|Outcome|24 mg SL BPN|Group 3: 24 mg SL BPN-daily
11269758|NCT02710526|OG002|Outcome|24 mg SL BPN|Group 3: 24 mg SL BPN daily
11269759|NCT02710526|OG002|Outcome|24 mg SL BPN|Group 3: 24mg SL BPN daily
11269760|NCT02710526|OG000|Outcome|32 mg CAM2038 Weekly|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269761|NCT02710526|OG001|Outcome|128 mg CAM2038 Monthly Injection|"Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269762|NCT02710526|OG002|Outcome|160 mg CAM2038 Monthly Injection|"Group 3: 160 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269763|NCT02710526|EG000|Reported Event|32 mg CAM2038 Weekly|"Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269764|NCT02710526|EG001|Reported Event|128 mg CAM2038 Monthly Injection|"Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269765|NCT02710526|EG002|Reported Event|160 mg CAM2038 Monthly Injection|"Group 3: 160 mg of CAM2038 subcutaneous monthly injection in the buttocks~CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine"
11269766|NCT02710526|EG003|Reported Event|24 mg SL BPN|Group 3: 24 mg Sublingual Buprenorphine (SL BPN) from day 1-7 in group 3
11269767|NCT02710591|BG000|Baseline|Cohort 1|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID; patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received Rimeporide during 4 weeks.
11269768|NCT02710591|BG001|Baseline|Cohort 2|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID; patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received Rimeporide during 4 weeks.
11269769|NCT02710591|BG002|Baseline|Cohort 3|5 patients in total: patients with a with a body weight less than or equal to 30kg at baseline were administered 150 mg TID; patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.
11269770|NCT02710591|BG003|Baseline|Cohort 4|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID; patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks
11269771|NCT02710591|BG004|Baseline|Total|Total of all reporting groups
11269772|NCT02710591|FG000|Participant Flow|Cohort 1|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID; patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received Rimeporide during 4 weeks.
11269773|NCT02710591|FG001|Participant Flow|Cohort 2|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID; patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received Rimeporide during 4 weeks.
11269774|NCT02710591|FG002|Participant Flow|Cohort 3|5 patients in total: patients with a with a body weight less than or equal to 30kg at baseline were administered 150 mg TID; patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.
11269775|NCT02710591|FG003|Participant Flow|Cohort 4|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID; patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks
11269776|NCT02710591|OG000|Outcome|Cohort 1|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID; patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received Rimeporide during 4 weeks.
11269777|NCT02710591|OG001|Outcome|Cohort 2|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID; patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received Rimeporide during 4 weeks.
11269778|NCT02710591|OG002|Outcome|Cohort 3|5 patients in total: patients with a with a body weight less than or equal to 30kg at baseline were administered 150 mg TID; patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.
11269779|NCT02710591|OG003|Outcome|Cohort 4|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID; patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks
11269780|NCT02710591|EG000|Reported Event|Cohort 1|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID; patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received Rimeporide during 4 weeks.
11269781|NCT02710591|EG001|Reported Event|Cohort 2|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID; patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received Rimeporide during 4 weeks.
11269782|NCT02710591|EG002|Reported Event|Cohort 3|5 patients in total: patients with a with a body weight less than or equal to 30kg at baseline were administered 150 mg TID; patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.
11269783|NCT02710591|EG003|Reported Event|Cohort 4|5 patients in total: patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID; patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks
11269784|NCT02710630|BG000|Baseline|Ref-A1-B1-C1-D1-E1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269785|NCT02710630|BG001|Baseline|Ref-B1-C1-D1-E1-A1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269786|NCT02710630|BG002|Baseline|Ref-C1-D1-E1-A1-B1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11337586|NCT03588572|OG000|Outcome|Venlafaxine Group|"The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.~Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization"
10847307|NCT00282672|OG003|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
10847308|NCT00282672|OG000|Outcome|HGD Radiofrequency Ablation|
11269787|NCT02710630|BG003|Baseline|Ref-D1-E1-A1-B1-C1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269788|NCT02710630|BG004|Baseline|Ref-E1-A1-B1-C1-D1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269789|NCT02710630|BG005|Baseline|Total|Total of all reporting groups
11269790|NCT02710630|FG000|Participant Flow|Ref-A1-B1-C1-D1-E1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation A1 (TF-A1) in period 2, followed by Test Formulation B1 (TF-B1) in period 3, followed by Test Formulation C1 (TF-C1) in period 4, followed by Test Formulation D1 (TF-D1) in period 5, followed by Test Formulation E1 (TF-E1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269791|NCT02710630|FG001|Participant Flow|Ref-B1-C1-D1-E1-A1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation B1 (TF-B1) in period 2, followed by Test Formulation C1 (TF-C1) in period 3, followed by Test Formulation D1 (TF-D1) in period 4, followed by Test Formulation E1 (TF-E1) in period 5, followed by Test Formulation A1 (TF-A1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269792|NCT02710630|FG002|Participant Flow|Ref-C1-D1-E1-A1-B1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation C1 (TF-C1) in period 2, followed by Test Formulation D1 (TF-D1) in period 3, followed by Test Formulation E1 (TF-E1) in period 4, followed by Test Formulation A1 (TF-A1) in period 5, followed by Test Formulation B1 (TF-B1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269793|NCT02710630|FG003|Participant Flow|Ref-D1-E1-A1-B1-C1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation D1 (TF-D1) in period 2, followed by Test Formulation E1 (TF-E1) in period 3, followed by Test Formulation A1 (TF-A1) in period 4, followed by Test Formulation B1 (TF-B1) in period 5, followed by Test Formulation C1 (TF-C1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269794|NCT02710630|FG004|Participant Flow|Ref-E1-A1-B1-C1-D1|"All subjects were treated with the reference treatment (Ref), Dabigatran Etexilate (BIBR 1048) commercial capsule formulation, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours in period 1, followed by one of the 5 investigational treatment in the following sequence, i.e., test formulation Dabigatran Etexilate tablet formulations in the sequence Test Formulation E1 (TF-E1) in period 2, followed by Test Formulation A1 (TF-A1) in period 3, followed by Test Formulation B1 (TF-B1) in period 4, followed by Test Formulation C1 (TF-C1) in period 5, followed by Test Formulation D1 (TF-D1) in period 6, 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.~A washout period of at least 4 days was set following the drug administration in each period."
11269795|NCT02710630|OG000|Outcome|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269796|NCT02710630|OG001|Outcome|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269797|NCT02710630|OG002|Outcome|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269798|NCT02710630|OG003|Outcome|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269799|NCT02710630|OG004|Outcome|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269800|NCT02710630|OG005|Outcome|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269801|NCT02710630|EG000|Reported Event|Dabigatran Etexilate Capsule: Ref|The subjects received Dabigatran Etexilate (Reference) capsule formulation (commercial formulation) 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269802|NCT02710630|EG001|Reported Event|Dabigatran Etexilate Tablet: A1|The subjects received Dabigatran Etexilate (Test) tablet formulation (A1), 110 mg orally (one day, single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269803|NCT02710630|EG002|Reported Event|Dabigatran Etexilate Tablet: B1|The subjects received Dabigatran Etexilate (Test) tablet formulation (B1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269804|NCT02710630|EG003|Reported Event|Dabigatran Etexilate Tablet: C1|The subjects received Dabigatran Etexilate (Test) tablet formulation (C1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269805|NCT02710630|EG004|Reported Event|Dabigatran Etexilate Tablet: D1|The subjects received Dabigatran Etexilate (Test) tablet formulation (D1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269806|NCT02710630|EG005|Reported Event|Dabigatran Etexilate Tablet: E1|The subjects received Dabigatran Etexilate (Test) tablet formulation (E1), 110 mg orally (one day single dose) with 200 mL of water after an overnight fast of at least 10 hours.
11269807|NCT02710890|BG000|Baseline|Lacosamide Age Cohort ≥ 1 Month - < 8 Years|This arm consisted of participants who formed Cohort 2, were greater than or equal to (≥) 1 month to less than (<) 8 years of age and received at least 1 dose of intravenous (iv) lacosamide (LCM). For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a Data Monitoring Committee (DMC) reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated.
11269808|NCT02710890|BG001|Baseline|Lacosamide Age Cohort ≥ 8 - < 17 Years|This arm consisted of participants who formed Cohort 1, were ≥ 8 to < 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
11269809|NCT02710890|BG002|Baseline|Total Title|
10847309|NCT00282672|OG001|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
11269810|NCT02710890|FG000|Participant Flow|Lacosamide Age Cohort ≥ 1 Month - < 8 Years|This arm consisted of participants who formed Cohort 2, were greater than or equal to (≥) 1 month to less than (<) 8 years of age and received at least 1 dose of intravenous (iv) lacosamide (LCM). For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a Data Monitoring Committee (DMC) reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated.
11269811|NCT02710890|FG001|Participant Flow|Lacosamide Age Cohort ≥ 8 - < 17 Years|This arm consisted of participants who formed Cohort 1, were ≥ 8 to < 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
11269812|NCT02710890|OG000|Outcome|Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)|This arm consisted of participants who formed Cohort 2, were ≥ 1 month to < 8 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated. Participants formed the Safety Set iv (SS-iv).
11269813|NCT02710890|OG001|Outcome|Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)|This arm consisted of participants who formed Cohort 1, were ≥ 8 to < 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2). Participants formed the Safety Set iv (SS-iv).
11269814|NCT02710890|EG000|Reported Event|Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)|This arm consisted of participants who formed Cohort 2, were ≥ 1 month to < 8 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated. Participants formed the Safety Set iv (SS-iv).
11337587|NCT03588572|OG001|Outcome|Controlled Group|the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
11269815|NCT02710890|EG001|Reported Event|Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)|This arm consisted of participants who formed Cohort 1, were ≥ 8 to < 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2). Participants formed the Safety Set iv (SS-iv).
11269816|NCT02710981|BG000|Baseline|Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)|Infertile women who have completed 5 cycles of clomiphene citrate with successful ovulation, thin endometrium and no pregnancy who are attempting a 6th cycle of clomiphene citrate.
11269817|NCT02710981|FG000|Participant Flow|Clomiphene Citrate Only|Clomiphene citrate only arm: Patients underwent 6th ovulation induction cycle in which women received Clomiphene citrate (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days). A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection). Period of this arm is one menstrual cycle (6th induction cycle)
11269818|NCT02710981|FG001|Participant Flow|Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)|Clomiphene citrate plus sildenafil vaginal gel arm: Women who did not conceive on the 6th cycle ( clomiphene citrate only cycle; 41 women) were offered a 7th cycle in which they were given Clomiphene citrate 100 mg/ day starting from day of the cycle for 5 days, with adding sildenafil vaginal gel 5 gm twice daily starting from cycle day 8 on until day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection). Period of this arm is the subsequent menstrual cycle (7th induction cycle)
11269819|NCT02710981|OG000|Outcome|Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)|Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium
11269820|NCT02710981|OG001|Outcome|Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)|Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
11269821|NCT02710981|OG001|Outcome|Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)|Women who did not get pregnant after 6th ovulation induction cycle with clomiphene citrate and placebo vaginal gel were offered a 7th cycle in which ovulation was induced with clomiphene citrate plus sildenafil vaginal gel
11269822|NCT02710981|OG001|Outcome|Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation|Women who did not get pregnant after 6th ovulation induction cycle with clomiphene citrate and placebo vaginal gel were offered a 7th ovulation induction cycle with clomiphene citrate and sildenafil vaginal gel
11269823|NCT02710981|EG000|Reported Event|Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)|Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium (N =41)
11269824|NCT02710981|EG001|Reported Event|Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)|Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
11269825|NCT02711306|BG000|Baseline|First GMN Then PN|"First Intervention (4 weeks, GMN), Washout (2 weeks) and Second Intervention (4 weeks, PN)"
11269826|NCT02711306|BG001|Baseline|First PN Then GMN|"First Intervention (4 weeks, PN), Washout (2 weeks) and Second Intervention (4 weeks, GMN)"
11269827|NCT02711306|BG002|Baseline|Total|Total of all reporting groups
11269828|NCT02711306|FG000|Participant Flow|First GMN Then PN|"First Intervention (4 weeks, GMN), Washout (2 weeks) and Second Intervention (4 weeks, PN)"
11269829|NCT02711306|FG001|Participant Flow|First PN Then GMN|"First Intervention (4 weeks, PN), Washout (2 weeks) and Second Intervention (4 weeks, GMN)"
11269830|NCT02711306|OG000|Outcome|GMN Diet|In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
11269831|NCT02711306|OG001|Outcome|PN Diet|In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
11269832|NCT02711306|EG000|Reported Event|GMN Diet|The 100 g GMN noodle contains 1 g of konjac glucomannan powder. Participants approximately consumed 2 g GMN per day in 200 g of noodle. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any probiotics or prebiotics.
10847310|NCT00282672|OG000|Outcome|LGD to HGD|
10847311|NCT00282672|OG001|Outcome|LGD to IMC|
11269833|NCT02711306|EG001|Reported Event|PN Diet|Isocaloric noodle with no konjac glucomannan powder in placebo comparator. The PN-participants daily consumed placebo noodle without any added GMN (approximately 200 g noodle per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any probiotics or prebiotics.
11269834|NCT02711345|BG000|Baseline|LTT462 45 mg QD|Participants received 45 mg LTT462 once QD as oral capsules.
11269835|NCT02711345|BG001|Baseline|LTT462 100 mg QD|Participants received 100 mg LTT462 QD as oral capsules.
11269836|NCT02711345|BG002|Baseline|LTT462 150 mg QD|Participants received 150 mg LTT462 QD as oral capsules.
11269837|NCT02711345|BG003|Baseline|LTT462 200 mg QD|Participants received 200 mg LTT462 QD as oral capsules.
11269838|NCT02711345|BG004|Baseline|LTT462 300 mg QD|Participants received 300 mg LTT462 QD as oral capsules.
11269839|NCT02711345|BG005|Baseline|LTT462 400 mg QD|Participants received 400 mg LTT462 QD as oral capsules.
11269840|NCT02711345|BG006|Baseline|LTT462 450 mg QD|Participants received 450 mg LTT462 QD as oral capsules.
11269841|NCT02711345|BG007|Baseline|LTT462 600 mg QD|Participants received 600 mg LTT462 QD as oral capsules.
11269842|NCT02711345|BG008|Baseline|LTT462 150 mg BID|Participants received 150 mg LTT462 BID as oral capsules.
11269843|NCT02711345|BG009|Baseline|LTT462 200 mg BID|Participants received 200 mg LTT462 BID as oral capsules.
11269844|NCT02711345|BG010|Baseline|Total|Total of all reporting groups
11269845|NCT02711345|FG000|Participant Flow|LTT462 45 mg QD|Participants received LTT462 45 milligram (mg) once daily (QD)
11269846|NCT02711345|FG001|Participant Flow|LTT462 100 mg QD|Participants received 100 mg LTT462 QD as oral capsules.
11269847|NCT02711345|FG002|Participant Flow|LTT462 150 mg QD|Participants received 150 mg LTT462 QD as oral capsules.
11269848|NCT02711345|FG003|Participant Flow|LTT462 200 mg QD|Participants received 200 mg LTT462 QD as oral capsules.
11269849|NCT02711345|FG004|Participant Flow|LTT462 300 mg QD|Participants received 300 mg LTT462 QD as oral capsules.
11269850|NCT02711345|FG005|Participant Flow|LTT462 400 mg QD|Participants received 400 mg LTT462 QD as oral capsules.
11269851|NCT02711345|FG006|Participant Flow|LTT462 450 mg QD|Participants received 450 mg LTT462 QD as oral capsules.
11269852|NCT02711345|FG007|Participant Flow|LTT462 600 mg QD|Participants received 600 mg LTT462 QD as oral capsules.
11269853|NCT02711345|FG008|Participant Flow|LTT462 150 mg BID|Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
11269854|NCT02711345|FG009|Participant Flow|LTT462 200 mg BID|Participants received 200 mg LTT462 BID as oral capsules.
11269855|NCT02711345|OG000|Outcome|LTT462 45 mg QD|Participants received 45 mg LTT462 QD as oral capsules.
11269856|NCT02711345|OG001|Outcome|LTT462 100 mg QD|Participants received 100 mg LTT462 QD as oral capsules.
11269857|NCT02711345|OG002|Outcome|LTT462 150 mg QD|Participants received 150 mg LTT462 QD as oral capsules.
11269858|NCT02711345|OG003|Outcome|LTT462 200 mg QD|Participants received 200 mg LTT462 QD as oral capsules.
11269859|NCT02711345|OG004|Outcome|LTT462 300 mg QD|Participants received 300 mg LTT462 QD as oral capsules.
11269860|NCT02711345|OG005|Outcome|LTT462 400 mg QD|Participants received 400 mg LTT462 QD as oral capsules.
11269861|NCT02711345|OG006|Outcome|LTT462 450 mg QD|Participants received 450 mg LTT462 QD as oral capsules.
11269862|NCT02711345|OG007|Outcome|LTT462 600 mg QD|Participants received 600 mg LTT462 QD as oral capsules.
10847312|NCT00282672|OG002|Outcome|HGD to IMC|
10847313|NCT00282672|OG000|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
11269863|NCT02711345|OG008|Outcome|LTT462 150 mg BID|Participants received 150 mg LTT462 BID as oral capsules.
11269864|NCT02711345|OG009|Outcome|LTT462 200 mg BID|Participants received 200 mg LTT462 BID as oral capsules.
11269865|NCT02711345|OG000|Outcome|LTT462 45 mg QD|Participants received 45 mg LTT462 once QD as oral capsules.
11269866|NCT02711345|OG008|Outcome|LTT462 150 mg BID|Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
11269867|NCT02711345|OG008|Outcome|LTT462 150 mg BID|Participants received 150 mg LTT462 twice daily (BID) as oral capsules
11269868|NCT02711345|EG000|Reported Event|LTT462 45 mg QD|Participants received 45 mg LTT462 QD as oral capsules.
11269869|NCT02711345|EG001|Reported Event|LTT462 100 mg QD|Participants received 100 mg LTT462 QD as oral capsules.
11269870|NCT02711345|EG002|Reported Event|LTT462 150 mg QD|Participants received 150 mg LTT462 QD as oral capsules.
11269871|NCT02711345|EG003|Reported Event|LTT462 200 mg QD|Participants received 200 mg LTT462 QD as oral capsules.
11269872|NCT02711345|EG004|Reported Event|LTT462 300 mg QD|Participants received 300 mg LTT462 QD as oral capsules.
11269873|NCT02711345|EG005|Reported Event|LTT462 400 mg QD|Participants received 400 mg LTT462 QD as oral capsules.
11269874|NCT02711345|EG006|Reported Event|LTT462 450 mg QD|Participants received 450 mg LTT462 QD as oral capsules.
11269875|NCT02711345|EG007|Reported Event|LTT462 600 mg QD|Participants received 450 mg LTT462 QD as oral capsules.
11269876|NCT02711345|EG008|Reported Event|All QD Participants|Participants received 45 to 600 mg LTT462 QD as oral capsules.
11269877|NCT02711345|EG009|Reported Event|LTT462 150 mg BID|Participants received 150 mg LTT462 BID as oral capsules.
11269878|NCT02711345|EG010|Reported Event|LTT462 200 mg BID|Participants received 200 mg LTT462 BID as oral capsules.
11269879|NCT02711345|EG011|Reported Event|All BID Participants|Participants received 150 and 200 mg LTT462 BID as oral capsules.
11269880|NCT02711553|BG000|Baseline|8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 8 mg/kg ramucirumab plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
11269881|NCT02711553|BG001|Baseline|Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269882|NCT02711553|BG002|Baseline|80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
11269883|NCT02711553|BG003|Baseline|Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269884|NCT02711553|BG004|Baseline|Total|Total of all reporting groups
11269885|NCT02711553|FG000|Participant Flow|8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
11269886|NCT02711553|FG001|Participant Flow|Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269887|NCT02711553|FG002|Participant Flow|80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
11269888|NCT02711553|FG003|Participant Flow|Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269889|NCT02711553|OG000|Outcome|8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 8 mg/kg ramucirumab plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
11269890|NCT02711553|OG001|Outcome|80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
11269891|NCT02711553|OG002|Outcome|Pooled Placebo|Participants received placebo IV and placebo oral (indistinguishable and equivalent volume to ramucirumab and merestinib) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269892|NCT02711553|OG000|Outcome|80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
11269893|NCT02711553|OG000|Outcome|8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
11269894|NCT02711553|OG001|Outcome|Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269895|NCT02711553|EG000|Reported Event|8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 8 mg/kg ramucirumab plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
11269896|NCT02711553|EG001|Reported Event|Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269897|NCT02711553|EG002|Reported Event|80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
11269898|NCT02711553|EG003|Reported Event|Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine|Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
11269899|NCT02711800|BG000|Baseline|Lactobacillus Rhamnosus|The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
11269900|NCT02711800|FG000|Participant Flow|Lactobacillus Rhamnosus|The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
11269901|NCT02711800|OG000|Outcome|Lactobacillus Rhamnosus|The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
11269902|NCT02711800|EG000|Reported Event|Lactobacillus Rhamnosus|The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
11269903|NCT02711839|BG000|Baseline|Control Group|"Commercial diabetic formula~Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269904|NCT02711839|BG001|Baseline|Treatment Group|"White sweet potato formula~White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269905|NCT02711839|BG002|Baseline|Total|Total of all reporting groups
11269906|NCT02711839|FG000|Participant Flow|Control Group|"Commercial diabetic formula~Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269907|NCT02711839|FG001|Participant Flow|Treatment Group|"White sweet potato formula~White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269908|NCT02711839|OG000|Outcome|Control Group|"Commercial diabetic formula~Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269909|NCT02711839|OG001|Outcome|Treatment Group|"White sweet potato formula~White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269910|NCT02711839|EG000|Reported Event|Control Group|"Commercial diabetic formula~Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269911|NCT02711839|EG001|Reported Event|Treatment Group|"White sweet potato formula~White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation"
11269912|NCT02711956|BG000|Baseline|DE-A - 48 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269913|NCT02711956|BG001|Baseline|DE-A - 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269914|NCT02711956|BG002|Baseline|DE-A - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269915|NCT02711956|BG003|Baseline|DE-A - 96 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269916|NCT02711956|BG004|Baseline|DE-A - 120 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269917|NCT02711956|BG005|Baseline|DE-A - 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269918|NCT02711956|BG006|Baseline|DE-B - 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269919|NCT02711956|BG007|Baseline|DE-B - 48 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269920|NCT02711956|BG008|Baseline|DE-B - 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269921|NCT02711956|BG009|Baseline|DE-B - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269922|NCT02711956|BG010|Baseline|DE-B - 96 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269923|NCT02711956|BG011|Baseline|DC-A - 48 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269924|NCT02711956|BG012|Baseline|DC-A - 96 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269925|NCT02711956|BG013|Baseline|DC-B - 48 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269926|NCT02711956|BG014|Baseline|DC-B - 96 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269927|NCT02711956|BG015|Baseline|Total|Total of all reporting groups
11269928|NCT02711956|FG000|Participant Flow|DE-A - 48 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269929|NCT02711956|FG001|Participant Flow|DE-A - 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11092276|NCT01538719|FG001|Participant Flow|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
11269930|NCT02711956|FG002|Participant Flow|DE-A - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269931|NCT02711956|FG003|Participant Flow|DE-A - 96 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269932|NCT02711956|FG004|Participant Flow|DE-A - 120 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269933|NCT02711956|FG005|Participant Flow|DE-A - 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269934|NCT02711956|FG006|Participant Flow|DE-B - 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269935|NCT02711956|FG007|Participant Flow|DE-B - 48 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269936|NCT02711956|FG008|Participant Flow|DE-B 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269937|NCT02711956|FG009|Participant Flow|DE-B - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269938|NCT02711956|FG010|Participant Flow|DE-B 96 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269939|NCT02711956|FG011|Participant Flow|DC-A 48 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269940|NCT02711956|FG012|Participant Flow|DC-A 96 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
11269941|NCT02711956|FG013|Participant Flow|DC-B 48 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
11269942|NCT02711956|FG014|Participant Flow|DC-B 96 mg ZEN003694 + Enzalutamide|Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
11269943|NCT02711956|OG000|Outcome|DE A+B - 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269944|NCT02711956|OG001|Outcome|DE A+B - 48 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269945|NCT02711956|OG002|Outcome|DE A+B - 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269946|NCT02711956|OG003|Outcome|DE A+B - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269947|NCT02711956|OG004|Outcome|DE A+B - 96 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269948|NCT02711956|OG005|Outcome|DE A+B - 120 mg ZEN003694 + Enzalutamide|Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269949|NCT02711956|OG006|Outcome|DE A+B - 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
10847314|NCT00282672|OG001|Outcome|LGD Radiofrequency Ablation|
10847315|NCT00282672|OG002|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
10847316|NCT00282672|OG000|Outcome|Sham Patients|Patients randomized to Sham Procedure arm.
10847317|NCT00282672|OG001|Outcome|Treatment Patients|Patients randomized to Radiofrequency Ablation at start of study and underwent RFA treatment at randomization.
10847318|NCT00282672|OG000|Outcome|All Study Participants|
10847319|NCT00282672|EG000|Reported Event|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
10847320|NCT00282672|EG001|Reported Event|LGD Radiofrequency Ablation|
10847321|NCT00282672|EG002|Reported Event|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
10847322|NCT00282672|EG003|Reported Event|HGD Radiofrequency Ablation|
10847323|NCT00282815|BG000|Baseline|Active Continuous Positive Airway Pressure (CPAP)|
10847324|NCT00282815|BG001|Baseline|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
10847325|NCT00282815|BG002|Baseline|Total|Total of all reporting groups
10847326|NCT00282815|FG000|Participant Flow|Active Continuous Positive Airway Pressure (CPAP)|
10847327|NCT00282815|FG001|Participant Flow|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
10847328|NCT00282815|OG000|Outcome|Active CPAP|
10847329|NCT00282815|OG001|Outcome|Sham CPAP|
10847330|NCT00282815|OG000|Outcome|After Randomization|
10847331|NCT00282815|OG000|Outcome|Active Continuous Positive Airway Pressure (CPAP)|
10847332|NCT00282815|OG001|Outcome|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
10847333|NCT00282815|EG000|Reported Event|Active Continuous Positive Airway Pressure (CPAP)|
11269950|NCT02711956|OG000|Outcome|DE - 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269951|NCT02711956|OG001|Outcome|DE/DC - 48 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269952|NCT02711956|OG002|Outcome|DE - 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269953|NCT02711956|OG003|Outcome|DE - 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269954|NCT02711956|OG004|Outcome|DE/DC - 96 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269955|NCT02711956|OG005|Outcome|DE - 120 mg ZEN003694 + Enzalutamide|Dose Escalation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269956|NCT02711956|OG006|Outcome|DE - 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269957|NCT02711956|OG000|Outcome|DE/DC-A ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 -144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269958|NCT02711956|OG001|Outcome|DE/DC-B ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 - 96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269959|NCT02711956|OG000|Outcome|DE/DC A ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort A - Enzalutamide/Apalutamide Progressors - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg - 144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269960|NCT02711956|OG001|Outcome|DE/DC B ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort B - Abiraterone Progressors - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg - 144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269961|NCT02711956|OG001|Outcome|DE/DC B ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort B -Abiraterone Progressors - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg - 144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269962|NCT02711956|OG000|Outcome|DE/DC A ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort A - Enzalutamide/Apalutamide Progressors - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg -144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269963|NCT02711956|OG001|Outcome|DE/DC B ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohort B - Abiraterone Progressors - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg -144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269964|NCT02711956|OG000|Outcome|DE A+B 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269965|NCT02711956|OG001|Outcome|DE/DC A+B 48 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269966|NCT02711956|OG002|Outcome|DE A+B 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269967|NCT02711956|OG003|Outcome|DE A+B 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269968|NCT02711956|OG004|Outcome|DE/DC A+B 96 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269969|NCT02711956|OG005|Outcome|DE A+B 120 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269970|NCT02711956|OG006|Outcome|DE A+B 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A +B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269971|NCT02711956|OG001|Outcome|DE/DC A+B 48 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
10847334|NCT00282815|EG001|Reported Event|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
10847335|NCT00282828|BG000|Baseline|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
10847336|NCT00282828|BG001|Baseline|Venlafaxine|Participants will take venlafaxine only
10847337|NCT00282828|BG002|Baseline|Sertraline and Placebo|Participants will take both sertraline and placebo
10847338|NCT00282828|BG003|Baseline|Total|Total of all reporting groups
10847339|NCT00282828|FG000|Participant Flow|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
10847340|NCT00282828|FG001|Participant Flow|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
10847341|NCT00282828|FG002|Participant Flow|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
11269972|NCT02711956|OG002|Outcome|DE A+B 60 mg ZEN003694 + Enzalutamide PO QD|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269973|NCT02711956|OG005|Outcome|DE A+B 120 mg ZEN003694 + Enzalutamide PO QD|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269974|NCT02711956|OG006|Outcome|DE A+B 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269975|NCT02711956|EG000|Reported Event|DE A+B 36 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269976|NCT02711956|EG001|Reported Event|DE/DC A+B 48 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269977|NCT02711956|EG002|Reported Event|DE A+B 60 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269978|NCT02711956|EG003|Reported Event|DE A+B 72 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269979|NCT02711956|EG004|Reported Event|DE/DC A+B 96 mg ZEN003694 + Enzalutamide|Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269980|NCT02711956|EG005|Reported Event|DE A+B 120 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269981|NCT02711956|EG006|Reported Event|DE A+B 144 mg ZEN003694 + Enzalutamide|Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
11269982|NCT02711995|BG000|Baseline|Botulinum Toxin First and RenuGel After|Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
11269983|NCT02711995|FG000|Participant Flow|Botulinum Toxin First and RenuGel After|Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
11269984|NCT02711995|OG000|Outcome|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
11269985|NCT02711995|OG001|Outcome|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
11269986|NCT02711995|EG000|Reported Event|Botulinum Toxin|"Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.~Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder."
11269987|NCT02711995|EG001|Reported Event|RenuGel|"Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.~RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders."
11269988|NCT02712008|BG000|Baseline|REGN910-3 (3 mg: 2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram (mg):2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32
11269989|NCT02712008|BG001|Baseline|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, week 4 and week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 or Week 20 and Q8 or Q12 through week 32.
11269990|NCT02712008|BG002|Baseline|Aflibercept 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI or REGN910-3 (6 mg:2 mg) at week 16 or 20 and Q8 through week 32.
11269991|NCT02712008|BG003|Baseline|Total|Total of all reporting groups
11269992|NCT02712008|FG000|Participant Flow|REGN910-3 (3 mg: 2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
11269993|NCT02712008|FG001|Participant Flow|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to week 12.
11269994|NCT02712008|FG002|Participant Flow|Aflibercept 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12.
11269995|NCT02712008|FG003|Participant Flow|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, week 4 and week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
11269996|NCT02712008|FG004|Participant Flow|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 20 and Q12 through Week 32.
11269997|NCT02712008|FG005|Participant Flow|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI at week 16 and Q8 through week 32.
11269998|NCT02712008|FG006|Participant Flow|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week 20 and Q12 through Week 32.
11269999|NCT02712008|FG007|Participant Flow|Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
11270000|NCT02712008|OG000|Outcome|REGN910-3 (3 mg: 2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32
11270001|NCT02712008|OG001|Outcome|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, week 4 and week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 or Week 20 and Q8 or Q12 through week 32.
11270002|NCT02712008|OG002|Outcome|Aflibercept 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI or REGN910-3 (6 mg:2 mg) at week 16 or 20 and Q8 through week 32.
11270003|NCT02712008|OG000|Outcome|REGN910-3 (3 mg: 2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram (mg):2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32
11270004|NCT02712008|OG001|Outcome|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, week 4 and week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
11270005|NCT02712008|OG002|Outcome|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 20 and Q12 through Week 32.
11270006|NCT02712008|OG003|Outcome|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI at week 16 and Q8 through week 32.
11270007|NCT02712008|OG004|Outcome|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week 20 and Q12 through Week 32.
11270008|NCT02712008|OG005|Outcome|Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
11270009|NCT02712008|EG000|Reported Event|REGN910-3 (3 mg: 2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram (mg):2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
11270010|NCT02712008|EG001|Reported Event|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, week 4 and week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 or Week 20 and Q8 or Q12 through week 32.
11270011|NCT02712008|EG002|Reported Event|Aflibercept 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI or REGN910-3 (6 mg:2 mg) at week 16 or 20 and Q8 through week 32.
11337588|NCT03588572|EG000|Reported Event|Venlafaxine Group|"The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.~Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization"
11270012|NCT02712047|BG000|Baseline|Total (Placebo+FF/VI 100/25mcg)|In this two-period crossover study, participants received FF/VI 100/25 mcg or matching placebo through DPI once daily in each morning for 14 days either in TP 1 or TP 2 as per randomization schedule. There was a 21-days monitoring/washout period between two treatments during which participants were allowed to take rescue medication if required. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270013|NCT02712047|FG000|Participant Flow|Fluticasone Furoate/Vilanterol (FF/VI) Followed by Placebo|Participants were administered with FF/VI 100/25 microgram (mcg) during TP 1 followed by matching Placebo during TP 2 through a dry powder inhaler (DPI) once daily each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270014|NCT02712047|FG001|Participant Flow|Placebo Followed by FF/VI|Participants were administered with Placebo during TP 1 followed by FF/VI 100/25 mcg during TP 2 through DPI once daily in each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270015|NCT02712047|OG000|Outcome|Placebo|Participants received matching Placebo in either of TP 1 or TP 2 through DPI once daily in each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270016|NCT02712047|OG001|Outcome|FF/VI 100/25mcg|Participants received FF/VI 100/25 mcg in either of TP 1 or TP 2 through DPI once daily in each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270017|NCT02712047|EG000|Reported Event|Placebo|Participants received matching Placebo in either of TP 1 or TP 2 through DPI once daily in each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270018|NCT02712047|EG001|Reported Event|FF/VI 100/25mcg|Participants received FF/VI 100/25 mcg in either of TP 1 or TP 2 through DPI once daily in each morning for 14 days. There was a 21-day monitoring/washout period between two treatments in this two-period crossover study. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study.
11270019|NCT02712099|BG000|Baseline|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
11270020|NCT02712099|BG001|Baseline|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
11270021|NCT02712099|BG002|Baseline|Total|Total of all reporting groups
11337589|NCT03588572|EG001|Reported Event|Controlled Group|the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
11337590|NCT03588741|BG000|Baseline|Turoctocog Alfa|The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
11270022|NCT02712099|FG000|Participant Flow|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
11270023|NCT02712099|FG001|Participant Flow|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
11270024|NCT02712099|OG000|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
11270025|NCT02712099|OG001|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
11270026|NCT02712099|EG000|Reported Event|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
11270027|NCT02712099|EG001|Reported Event|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
11270028|NCT02712320|BG000|Baseline|LMIS 50 mg|"All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)~LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate"
11270029|NCT02712320|FG000|Participant Flow|LMIS 50 mg|"All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)~LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate"
11270030|NCT02712320|OG000|Outcome|LMIS 50 mg|"All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)~LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate"
11270031|NCT02712320|EG000|Reported Event|LMIS 50 mg|"All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)~LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate"
11270032|NCT02712333|BG000|Baseline|Group1-air Purification First, Then Sham Air Purification|"Participants in this group received a treatment of true air purification first, and then switched to the sham purification treatment the second stage.~For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment."
10847342|NCT00282828|OG000|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
11270033|NCT02712333|BG001|Baseline|Group2-sham Air Purification First, Then Real Air Purification|"Participants in this group received a treatment of sham air purification first, and then switched to the real purification treatment the second stage.~For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment."
11270034|NCT02712333|BG002|Baseline|Total|Total of all reporting groups
11270035|NCT02712333|FG000|Participant Flow|Group 1-air Purification First, Then Sham Air Purification|"Participants in this group received an intervention of true air purifiers placed in the center of the room.~Real Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment."
11270036|NCT02712333|FG001|Participant Flow|Group2-sham Air Purification First, Then Real Air Purification|"Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.~Sham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment."
11270037|NCT02712333|OG000|Outcome|Real Purification|Participants in this group received a treatment of air purification.
11270038|NCT02712333|OG001|Outcome|Sham Purification|Participants received sham air purification first.
11270039|NCT02712333|OG000|Outcome|Real Purification|Participants received a treatment of air purification
11270040|NCT02712333|OG001|Outcome|Sham Purification|Participants received a treatment of sham air purification
11270041|NCT02712333|OG000|Outcome|Real Purification|Participants received a treatment of real air purification.
11270042|NCT02712333|OG001|Outcome|Sham Air Purification|Participants received a treatment of sham air purification.
11270043|NCT02712333|OG001|Outcome|Sham Air Purification|Participants received a treatment of sham air purification
11270044|NCT02712333|EG000|Reported Event|Real Air Purification|"Participants in this group received an intervention of true air purifiers placed in the center of the room.~Real Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment."
11270045|NCT02712333|EG001|Reported Event|Sham Air Purification|"Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.~Sham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment."
11270046|NCT02712359|BG000|Baseline|Havrix 1 dose_Year 8 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270047|NCT02712359|BG001|Baseline|Havrix 2 doses_Year 8 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270048|NCT02712359|BG002|Baseline|Havrix 1 dose_Year 10 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270049|NCT02712359|BG003|Baseline|Havrix 2 doses_Year 10 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270050|NCT02712359|BG004|Baseline|Total|Total of all reporting groups
11270051|NCT02712359|FG000|Participant Flow|Havrix 1 dose_Year 8 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270052|NCT02712359|FG001|Participant Flow|Havrix 2 doses_Year 8 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270053|NCT02712359|FG002|Participant Flow|Havrix 1 dose_Year 10 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270054|NCT02712359|FG003|Participant Flow|Havrix 2 doses_Year 10 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270055|NCT02712359|OG000|Outcome|Havrix 1 dose_Year 8 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270056|NCT02712359|OG001|Outcome|Havrix 2 doses_Year 8 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270057|NCT02712359|OG000|Outcome|Havrix 1 dose_Year 10 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270058|NCT02712359|OG001|Outcome|Havrix 2 doses_Year 10 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270059|NCT02712359|EG000|Reported Event|Havrix 1 dose_Year 8 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270060|NCT02712359|EG001|Reported Event|Havrix 2 doses_Year 8 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
11270061|NCT02712359|EG002|Reported Event|Havrix 1 dose_Year 10 Group|Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270062|NCT02712359|EG003|Reported Event|Havrix 2 doses_Year 10 Group|Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
11270063|NCT02712398|BG000|Baseline|Phasix™ ST|"Subjects treated with Phasix™ ST mesh~Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable."
11270064|NCT02712398|FG000|Participant Flow|Phasix™ ST|"Subjects treated with Phasix™ ST mesh~Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable."
11270065|NCT02712398|OG000|Outcome|Phasix™ ST|"Subjects treated with Phasix™ ST mesh~Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable."
11270066|NCT02712398|EG000|Reported Event|Phasix™ ST|"Subjects treated with Phasix™ ST mesh~Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable."
11270067|NCT02712424|BG000|Baseline|DAR-901|"0.1 mL intradermal injection of 1 mg DAR-901~DAR-901"
11270068|NCT02712424|BG001|Baseline|Placebo|"0.1 mL intradermal injection of sterile saline for human use~Sterile saline placebo"
11270069|NCT02712424|BG002|Baseline|Total|Total of all reporting groups
11270070|NCT02712424|FG000|Participant Flow|DAR-901|"0.1 mL intradermal injection of 1 mg DAR-901~DAR-901"
11270071|NCT02712424|FG001|Participant Flow|Placebo|"0.1 mL intradermal injection of sterile saline for human use~Sterile saline placebo"
11270072|NCT02712424|OG000|Outcome|DAR-901|"0.1 mL intradermal injection of 1 mg DAR-901~DAR-901"
11270073|NCT02712424|OG001|Outcome|Placebo|"0.1 mL intradermal injection of sterile saline for human use~Sterile saline placebo"
11270074|NCT02712424|EG000|Reported Event|DAR-901|"0.1 mL intradermal injection of 1 mg DAR-901~DAR-901"
11270075|NCT02712424|EG001|Reported Event|Placebo|"0.1 mL intradermal injection of sterile saline for human use~Sterile saline placebo"
11270076|NCT02712554|BG000|Baseline|Part A (Dose Selection Phase): CL-108 or Placebo|"Treatment AA: CL-108 15 mg/650 mg/25 mg tablet by mouth~Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth~Treatment CC: CL-108 30 mg/1300 mg/50 mg tablet by mouth~Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth~Treatment EE: Placebo 0 mg tablet by mouth"
11270077|NCT02712554|BG001|Baseline|Part B (Treatment Phase): CL-108, M366 and Placebo|"Treatment A (low-dose): CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth~Treatment B (high-dose): CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth~Treatment C (low-dose): M366 22.5 mg/975 mg tablet by mouth~Treatment D (high-dose): M366 37.5 mg/1625 mg tablet by mouth~Treatment E: Placebo 0 mg tablet by mouth"
11270078|NCT02712554|BG002|Baseline|Total|Total of all reporting groups
11270079|NCT02712554|FG000|Participant Flow|Part A (Dose Selection Phase): CL-108 or Placebo|"Treatment AA: CL-108 15 mg/650 mg/25 mg tablet by mouth~Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth~Treatment CC: CL-108 30 mg/1300 mg/50 mg tablet by mouth~Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth~Treatment EE: Placebo 0 mg tablet by mouth"
11270080|NCT02712554|FG001|Participant Flow|Part B (Treatment Phase): CL-108, M366 and Placebo|"Treatment A (low-dose): CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth~Treatment B (high-dose): CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth~Treatment C (low-dose): M366 22.5 mg/975 mg tablet by mouth~Treatment D (high-dose): M366 37.5 mg/1625 mg tablet by mouth~Treatment E: Placebo 0 mg tablet by mouth"
11270081|NCT02712554|OG000|Outcome|Treatment AA: CL-108 15 mg/650 mg/25 mg|CL-108 15 mg/650 mg/25 mg tablet by mouth
11270082|NCT02712554|OG001|Outcome|Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg|CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
11270083|NCT02712554|OG002|Outcome|Treatment CC: CL-108 30 mg/1300 mg/50 mg|CL-108 30 mg/1300 mg/50 mg tablet by mouth
11270084|NCT02712554|OG003|Outcome|Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg|CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
11270085|NCT02712554|OG004|Outcome|Treatment EE: Placebo|Placebo 0 mg tablet by mouth
11270086|NCT02712554|OG000|Outcome|Treatment A: CL-108 22.5 mg/975 mg/37.5 mg|CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
11270087|NCT02712554|OG001|Outcome|Treatment B: CL-108 37.5 mg/1625 mg/62.5 mg|CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
11270088|NCT02712554|OG002|Outcome|Treatment C: M366 22.5 mg/975 mg|M366 22.5 mg/975 mg tablet by mouth
11270089|NCT02712554|OG003|Outcome|Treatment D: M366 37.5 mg/1625 mg|M366 37.5 mg/1625 mg tablet by mouth
11270090|NCT02712554|OG004|Outcome|Treatment E: Placebo|Placebo 0 mg tablet by mouth
11270091|NCT02712554|OG000|Outcome|Part A: Dose Selection Phase|"Naloxone 0.2 mg bolus intravenously followed by a 10 mL saline flush~CL-108 15 mg/650 mg/25 mg~CL-108 22.5 mg/975 mg/37.5 mg~CL-108 30 mg/1300 mg/50 mg~CL-108 37.5 mg/1625 mg/62.5 mg~Placebo 0 mg"
11270092|NCT02712554|EG000|Reported Event|Dose Selection AA: CL-108 15 mg/650 mg/25 mg|CL-108 15 mg/650 mg/25 mg tablet by mouth
11270093|NCT02712554|EG001|Reported Event|Dose Selection BB: CL-108 22.5 mg/975 mg/37.5 mg|CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
11270094|NCT02712554|EG002|Reported Event|Dose Selection CC: CL-108 30 mg/1300 mg/50 mg|CL-108 30 mg/1300 mg/50 mg tablet by mouth
11270095|NCT02712554|EG003|Reported Event|Dose Selection CC: CL-108 37.5 mg/1625 mg/62.5 mg|CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
11270096|NCT02712554|EG004|Reported Event|Dose Selection EE: Placebo|Placebo 0 mg tablet by mouth
11270097|NCT02712554|EG005|Reported Event|Treatment AA: CL-108 22.5 mg/975 mg/37.5 mg|CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
11270098|NCT02712554|EG006|Reported Event|Treatment BB: CL-108 37.5 mg/1625 mg/62.5 mg|CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
11270099|NCT02712554|EG007|Reported Event|Treatment CC: M366 22.5 mg/975 mg|M366 22.5 mg/975 mg tablet by mouth
11270100|NCT02712554|EG008|Reported Event|Treatment DD: M366 37.5 mg/1625 mg|M366 37.5 mg/1625 mg tablet by mouth
11270101|NCT02712554|EG009|Reported Event|Treatment EE: Placebo|Placebo 0 mg tablet by mouth
11270102|NCT02712788|BG000|Baseline|Milrinone|"Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Milrinone"
11270103|NCT02712788|BG001|Baseline|Placebo|"Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Placebo"
11270104|NCT02712788|BG002|Baseline|Total|Total of all reporting groups
10970156|NCT00909155|EG000|Reported Event|Currently Depressed Subjects; Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
11270105|NCT02712788|FG000|Participant Flow|Milrinone|"Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Milrinone"
11270106|NCT02712788|FG001|Participant Flow|Placebo|"Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Placebo"
11270107|NCT02712788|OG000|Outcome|Milrinone|"Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Milrinone"
11270108|NCT02712788|OG001|Outcome|Placebo|"Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Placebo"
11270109|NCT02712788|EG000|Reported Event|Milrinone|"Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Milrinone"
11270110|NCT02712788|EG001|Reported Event|Placebo|"Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.~Placebo"
11270111|NCT02712983|BG000|Baseline|Cohort A (3 Capsules o.d.): TIP|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
11270112|NCT02712983|BG001|Baseline|Cohort A (3 Capsules o.d.): TIP/PBO|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270113|NCT02712983|BG002|Baseline|Cohort A (3 Capsules o.d.): PBO|Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
11270114|NCT02712983|BG003|Baseline|Cohort B (5 Capsules o.d.): TIP|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
11270115|NCT02712983|BG004|Baseline|Cohort B (5 Capsules o.d.): TIP/PBO|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270116|NCT02712983|BG005|Baseline|Cohort B (5 Capsules o.d.): PBO|Cohort B (5 capsules o.d.): inhaled placebo (PBO)
11270117|NCT02712983|BG006|Baseline|Cohort C (4 Capsules b.i.d.): TIP|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
11270118|NCT02712983|BG007|Baseline|Cohort C (4 Capsules b.i.d.): TIP/PBO|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270119|NCT02712983|BG008|Baseline|Cohort C (4 Capsules b.i.d.): PBO|Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
11270120|NCT02712983|BG009|Baseline|Total|Total of all reporting groups
11270121|NCT02712983|FG000|Participant Flow|Cohort A (3 Capsules o.d.): TIP|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
11270122|NCT02712983|FG001|Participant Flow|Cohort A (3 Capsules o.d.): TIP/PBO|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270123|NCT02712983|FG002|Participant Flow|Cohort A (3 Capsules o.d.): PBO|Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
11270124|NCT02712983|FG003|Participant Flow|Cohort B (5 Capsules o.d.): TIP|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
11270125|NCT02712983|FG004|Participant Flow|Cohort B (5 Capsules o.d.): TIP/PBO|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270126|NCT02712983|FG005|Participant Flow|Cohort B (5 Capsules o.d.): PBO|Cohort B (5 capsules o.d.): inhaled placebo (PBO)
11270127|NCT02712983|FG006|Participant Flow|Cohort C (4 Capsules b.i.d.): TIP|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
11270128|NCT02712983|FG007|Participant Flow|Cohort C (4 Capsules b.i.d.): TIP/PBO|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270129|NCT02712983|FG008|Participant Flow|Cohort C (4 Capsules b.i.d.): PBO|Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
11270130|NCT02712983|OG000|Outcome|Cohort A (3 Capsules o.d.): TIP|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
11270131|NCT02712983|OG001|Outcome|Cohort A (3 Capsules o.d.): TIP/PBO|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270132|NCT02712983|OG002|Outcome|Cohort B (5 Capsules o.d.): TIP|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
11270133|NCT02712983|OG003|Outcome|Cohort B (5 Capsules o.d.): TIP/PBO|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270134|NCT02712983|OG004|Outcome|Cohort C (4 Capsules b.i.d.): TIP|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
11270135|NCT02712983|OG005|Outcome|Cohort C (4 Capsules b.i.d.): TIP/PBO|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270136|NCT02712983|OG006|Outcome|Pooled TIP|Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
11270137|NCT02712983|OG007|Outcome|Pooled TIP/PBO|Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
11270138|NCT02712983|OG008|Outcome|Pooled PBO|Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
11270139|NCT02712983|EG000|Reported Event|Cohort A (3 Capsules o.d.): TIP|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
11270140|NCT02712983|EG001|Reported Event|Cohort A (3 Capsules o.d.): TIP/PBO|Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270141|NCT02712983|EG002|Reported Event|Cohort A (3 Capsules o.d.): PBO|Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
11270142|NCT02712983|EG003|Reported Event|Cohort B (5 Capsules o.d.): TIP|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
11270143|NCT02712983|EG004|Reported Event|Cohort B (5 Capsules o.d.): TIP/PBO|Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270144|NCT02712983|EG005|Reported Event|Cohort B (5 Capsules o.d.): PBO|Cohort B (5 capsules o.d.): inhaled placebo (PBO)
11270145|NCT02712983|EG006|Reported Event|Cohort C:4 Capsules b.i.d. TIP|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
11270146|NCT02712983|EG007|Reported Event|Cohort C (4 Capsules b.i.d.): TIP/PBO|Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
11270147|NCT02712983|EG008|Reported Event|Cohort C (4 Capsules b.i.d.): PBO|Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
11270148|NCT02712996|BG000|Baseline|Lisdexamfetamine (Vyvanse) Then Placebo|Participants first received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks. Then on day 43 after treatment initiation, each subject received Placebo capsule, 20-70 mg, each morning for 6 weeks
11270149|NCT02712996|BG001|Baseline|Placebo Then Lisdexamfetamine (Vyvanse)|Participants first received Placebo capsule, 20-70 mg, each morning for 6 weeks. Then on day 43 after treatment initiation, each subject received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.
11270150|NCT02712996|BG002|Baseline|Total|Total of all reporting groups
11270151|NCT02712996|FG000|Participant Flow|Lisdexamfetamine (Vyvanse) Then Placebo|Participants first received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks. On day 43 after treatment initiation, each subject was switched to placebo capsule, 20-70 mg, each morning for 6 weeks.
11270152|NCT02712996|FG001|Participant Flow|Placebo Then Vyvanse|Participants first received Placebo capsule, 20-70 mg, each morning for 6 weeks. On day 43 after treatment initiation, participants received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks
11270153|NCT02712996|OG000|Outcome|Lisdexamfetamine (Vyvanse)|Participants who received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning in either the or last 6 weeks of the study.
11270154|NCT02712996|OG001|Outcome|Placebo|Participants who received Placebo capsule, 20-70 mg, each morning in either the or last 6 weeks of the study.
11270155|NCT02712996|OG000|Outcome|Vyvanse|"Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.~Lisdexamfetamine: Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks."
11270156|NCT02712996|OG001|Outcome|Placebo|"Placebo capsule, 20-70 mg, each morning for 6 weeks.~Placebo: Placebo capsule, 20-70 mg, each morning for 6 weeks."
11270157|NCT02712996|EG000|Reported Event|Lisdexamfetamine (Vyvanse)|Participants who received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning in either the first or last 6 weeks of the study.
11270158|NCT02712996|EG001|Reported Event|Placebo|Participants who received Placebo capsule, 20-70 mg, each morning in either the first or last 6 weeks of the study.
11270159|NCT02713178|BG000|Baseline|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270160|NCT02713178|BG001|Baseline|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≥1 h preoperatively
11270161|NCT02713178|BG002|Baseline|Placebo|20 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270162|NCT02713178|BG003|Baseline|Total|Total of all reporting groups
11270163|NCT02713178|FG000|Participant Flow|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270164|NCT02713178|FG001|Participant Flow|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≥1 h preoperatively
11270165|NCT02713178|FG002|Participant Flow|Placebo|20 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270166|NCT02713178|OG000|Outcome|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270167|NCT02713178|OG001|Outcome|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≥1 h preoperatively
11270168|NCT02713178|OG002|Outcome|Placebo|20 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270169|NCT02713178|EG000|Reported Event|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270170|NCT02713178|EG001|Reported Event|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≥1 h preoperatively
11270171|NCT02713178|EG002|Reported Event|Placebo|20 mL normal saline as single-injection femoral nerve block ≥1 h preoperatively
11270172|NCT02713204|BG000|Baseline|REGN910-3 (3 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.
11270173|NCT02713204|BG001|Baseline|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 or Week 20 and Q8 or Q12 through Week 32.
11270174|NCT02713204|BG002|Baseline|Aflibercept (IAI) 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270175|NCT02713204|BG003|Baseline|Total|Total of all reporting groups
11270176|NCT02713204|FG000|Participant Flow|REGN910-3 (3 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.
11270177|NCT02713204|FG001|Participant Flow|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
11270178|NCT02713204|FG002|Participant Flow|Aflibercept 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270179|NCT02713204|FG003|Participant Flow|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270180|NCT02713204|FG004|Participant Flow|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32.
11270181|NCT02713204|FG005|Participant Flow|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI Q8 beginning at week 16 through week 32.
11092277|NCT01538719|OG000|Outcome|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
11270182|NCT02713204|FG006|Participant Flow|Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.
11270183|NCT02713204|FG007|Participant Flow|Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270184|NCT02713204|OG000|Outcome|REGN910-3 (3 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.
11270185|NCT02713204|OG001|Outcome|REGN910-3 (6 mg:2 mg)|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
11270186|NCT02713204|OG002|Outcome|Aflibercept (IAI) 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270187|NCT02713204|OG001|Outcome|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270188|NCT02713204|OG002|Outcome|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32.
11270189|NCT02713204|OG003|Outcome|Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
11270190|NCT02713204|OG004|Outcome|Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.
11270191|NCT02713204|OG005|Outcome|Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270192|NCT02713204|OG003|Outcome|Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
11270193|NCT02713204|OG003|Outcome|Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32
11270194|NCT02713204|OG002|Outcome|REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32.
11270195|NCT02713204|EG000|Reported Event|REGN910-3 3 mg:2 mg|Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.
11270196|NCT02713204|EG001|Reported Event|REGN910-3 6 mg:2 mg|Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
11270197|NCT02713204|EG002|Reported Event|IAI 2 mg|Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
11270198|NCT02713204|EG003|Reported Event|IAI 2mg to REGN910-3|"Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.~Data in this arm include only the 58 participants that switched to high dose at week 16. Data from these 58 participants are also included in the Aflibercept (IAI) 2 mg arm (n = 183)."
11270199|NCT02713230|BG000|Baseline|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270200|NCT02713230|BG001|Baseline|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270201|NCT02713230|BG002|Baseline|Placebo|20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270202|NCT02713230|BG003|Baseline|Total|Total of all reporting groups
11270203|NCT02713230|FG000|Participant Flow|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270204|NCT02713230|FG001|Participant Flow|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270205|NCT02713230|FG002|Participant Flow|Placebo|20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270206|NCT02713230|OG000|Outcome|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270207|NCT02713230|OG001|Outcome|Placebo|20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270208|NCT02713230|EG000|Reported Event|EXPAREL 133 mg|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270209|NCT02713230|EG001|Reported Event|EXPAREL 266 mg|20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270210|NCT02713230|EG002|Reported Event|Placebo|20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
11270211|NCT02713243|BG000|Baseline|LJN452 Followed by Placebo|Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
11270212|NCT02713243|BG001|Baseline|Placebo Followed by LJN452|Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
11270213|NCT02713243|BG002|Baseline|Total|Total of all reporting groups
11270214|NCT02713243|FG000|Participant Flow|LJN452 Followed by Placebo|Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
11270215|NCT02713243|FG001|Participant Flow|Placebo Followed by LJN452|Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
11270216|NCT02713243|OG000|Outcome|LJN452 ALL Patients|All Patients on LJN452 in both Period 1 and Period 2
11270217|NCT02713243|OG001|Outcome|Placebo ALL Patients|All Patients on Placebo in both Period 1 and Period 2
11270218|NCT02713243|EG000|Reported Event|LJN452 ALL Patients|All Patients on LJN452 in both Period 1 and Period 2
11270219|NCT02713243|EG001|Reported Event|Placebo ALL Patients|All Patients on Placebo in both Period 1 and Period 2
11270220|NCT02713256|BG000|Baseline|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
11270221|NCT02713256|FG000|Participant Flow|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
11270222|NCT02713256|OG000|Outcome|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
11270223|NCT02713256|EG000|Reported Event|CFZ533 10 mg/kg|CFZ533 intravenously over approximately one hour
11337591|NCT03588741|FG000|Participant Flow|Turoctocog Alfa|The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
10970157|NCT00909155|EG001|Reported Event|Currently Depressed Subjects; Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
11337592|NCT03588741|OG000|Outcome|Turoctocog Alfa|The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
11337593|NCT03588741|EG000|Reported Event|Turoctocog Alfa|The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
11337594|NCT03588806|BG000|Baseline|Xtampza ER (Oxycodone) Treatment|"Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.~Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study."
11337595|NCT03588806|FG000|Participant Flow|Xtampza ER (Oxycodone) Treatment|"Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.~Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study."
11337596|NCT03588806|OG000|Outcome|Xtampza ER (Oxycodone) Treatment|"Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.~Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study."
11337597|NCT03588806|EG000|Reported Event|Xtampza ER (Oxycodone) Treatment|"Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.~Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study."
11337598|NCT03588910|BG000|Baseline|Number of Oxycodone Tablets Typically Prescribed|"Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11337599|NCT03588910|BG001|Baseline|Half the Number of Oxycodone Tablets Typically Prescribed|"Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11337600|NCT03588910|BG002|Baseline|Total|Total of all reporting groups
11337601|NCT03588910|FG000|Participant Flow|Number of Oxycodone Tablets Typically Prescribed|"Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11270224|NCT02713425|BG000|Baseline|Single Arm - Entertaining Video Game|"The children in this study will have a single visit. During this visit they will be introduced to the game. The child will then interact with the game and after they have finished, they will be asked questions about their experience with the game.~Entertaining Video Game: Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game."
11270225|NCT02713425|FG000|Participant Flow|Single Arm - Entertaining Video Game|"The children in this study will have a single visit. During this visit they will be introduced to the game. The child will then interact with the game and after they have finished, they will be asked questions about their experience with the game.~Entertaining Video Game: Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game."
11270226|NCT02713425|OG000|Outcome|Single Arm - Entertaining Video Game|"The children in this study will have a single visit. During this visit they will be introduced to the game. The child will then interact with the game and after they have finished, they will be asked questions about their experience with the game.~Entertaining Video Game: Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game."
11270227|NCT02713425|EG000|Reported Event|Single Arm - Entertaining Video Game|"The children in this study will have a single visit. During this visit they will be introduced to the game. The child will then interact with the game and after they have finished, they will be asked questions about their experience with the game.~Entertaining Video Game: Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game."
11270228|NCT02713490|BG000|Baseline|EXPAREL|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
11270229|NCT02713490|BG001|Baseline|Bupivacaine|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
11270230|NCT02713490|BG002|Baseline|Total|Total of all reporting groups
11270231|NCT02713490|FG000|Participant Flow|EXPAREL 266 mg + Bupivacaine HCl|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
11270232|NCT02713490|FG001|Participant Flow|Bupivacaine HCl|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
11270233|NCT02713490|OG000|Outcome|EXPAREL|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
11270234|NCT02713490|OG001|Outcome|Bupivacaine|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
11270235|NCT02713490|EG000|Reported Event|EXPAREL|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
11270236|NCT02713490|EG001|Reported Event|Bupivacaine|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
11270237|NCT02713529|BG000|Baseline|Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg|Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
11270238|NCT02713529|BG001|Baseline|Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg|"Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.~If >= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg."
11270239|NCT02713529|BG002|Baseline|Part 2, Group 1: CRC MMR-proficient|"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270240|NCT02713529|BG003|Baseline|Part 2, Group 2: Pancreatic Cancer|"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270241|NCT02713529|BG004|Baseline|Part 2, Group 3: NSCLC PD-L1 Low, Naïve|"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270242|NCT02713529|BG005|Baseline|Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low|"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (<50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270243|NCT02713529|BG006|Baseline|Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High|"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (>=50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270244|NCT02713529|BG007|Baseline|Total|Total of all reporting groups
11270245|NCT02713529|FG000|Participant Flow|Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg|Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
11270246|NCT02713529|FG001|Participant Flow|Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg|"Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.~If >= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg."
11270247|NCT02713529|FG002|Participant Flow|Part 2, Group 1: CRC MMR-proficient|"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270248|NCT02713529|FG003|Participant Flow|Part 2, Group 2: Pancreatic Cancer|"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270249|NCT02713529|FG004|Participant Flow|Part 2, Group 3: NSCLC PD-L1 Low, Naïve|"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270250|NCT02713529|FG005|Participant Flow|Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low|"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (<50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270251|NCT02713529|FG006|Participant Flow|Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High|"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (>=50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270252|NCT02713529|OG000|Outcome|Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg|Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
11270253|NCT02713529|OG001|Outcome|Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg|"Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.~If >= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg."
10970158|NCT00909155|EG002|Reported Event|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
10970159|NCT00909181|BG000|Baseline|Oxybutynin Gel 56 mg/Day|
11270254|NCT02713529|OG002|Outcome|Part 2, Group 1: CRC MMR-proficient|"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270255|NCT02713529|OG003|Outcome|Part 2, Group 2: Pancreatic Cancer|"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270256|NCT02713529|OG004|Outcome|Part 2, Group 3: NSCLC PD-L1 Low, Naïve|"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270257|NCT02713529|OG005|Outcome|Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low|"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (<50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270258|NCT02713529|OG006|Outcome|Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High|"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (>=50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270259|NCT02713529|OG000|Outcome|Part 1: AMG 820 + Pem|Part 1 Cohorts 1 + 2 combined. Participants with advanced solid tumors were treated with 1400 mg or 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
11270260|NCT02713529|OG001|Outcome|Part 2, Group 1: CRC MMR-proficient|"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270261|NCT02713529|OG002|Outcome|Part 2, Group 2: Pancreatic Cancer|"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270262|NCT02713529|OG003|Outcome|Part 2, Group 3: NSCLC PD-L1 Low, Naïve|"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
10847343|NCT00282828|OG001|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
10970160|NCT00909181|BG001|Baseline|Oxybutynin Gel 84 mg/Day|
10970161|NCT00909181|BG002|Baseline|Placebo Gel|
11270263|NCT02713529|OG004|Outcome|Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low|"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (<50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270264|NCT02713529|OG005|Outcome|Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High|"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (>=50%).~AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent."
11270265|NCT02713529|OG000|Outcome|Part 1: AMG 820 + Pem 200 mg|Part 1 Cohorts 1 + 2 combined. Participants with advanced solid tumors were treated with 1400 mg or 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
11270266|NCT02713529|OG000|Outcome|AMG 820 1100 mg|Includes participants from all treatment arms that were administered AMG 820 1100 mg.
11270267|NCT02713529|OG001|Outcome|AMG 820 1400 mg|Includes participants from all treatment arms who were administered AMG 820 1400 mg
11270268|NCT02713529|EG000|Reported Event|AMG 820 1100 MG|Includes participants from all treatment arms that were administered AMG 820 1100 mg.
11270269|NCT02713529|EG001|Reported Event|AMG 820 1400 MG|Includes participants from all treatment arms that were administered AMG 820 1400 mg.
11270270|NCT02713542|BG000|Baseline|Experimental: Autologous Conditioned Plasma (ACP)|Three Intra-articular injections of ACP in knee at 1 week intervals
11270271|NCT02713542|BG001|Baseline|Control: Normal Saline (NS)|Three Intra-articular injections of NS in knee knee at 1 week intervals
11270272|NCT02713542|BG002|Baseline|Total|Total of all reporting groups
11270273|NCT02713542|FG000|Participant Flow|Autologous Conditioned Plasma (ACP)|"3 Intra-articular (IA) injections at 1 week intervals~ACP: Autologous Conditioned Plasma"
11270274|NCT02713542|FG001|Participant Flow|Normal Saline (NS)|"3 NS Intra-articular (IA) injections at 1 week intervals~Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals."
11270275|NCT02713542|OG000|Outcome|Autologous Conditioned Plasma|3 Intra-articular injections of ACP in knee at 1 week intervals
11270276|NCT02713542|OG001|Outcome|Normal Saline|3 Intra-articular injections of NS in knee at 1 week intervals
11270277|NCT02713542|EG000|Reported Event|Autologous Conditioned Plasma (ACP)|"3 Intra-articular (IA) injections at 1 week intervals~ACP: Autologous Conditioned Plasma"
11270278|NCT02713542|EG001|Reported Event|Normal Saline (NS)|"3 NS Intra-articular (IA) injections at 1 week intervals~Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals."
11270279|NCT02713594|BG000|Baseline|Control|Counseling from WTQL
11270280|NCT02713594|BG001|Baseline|Incentive|Counseling from WTQL; Financial incentive to participate
11270281|NCT02713594|BG002|Baseline|Total|Total of all reporting groups
11270282|NCT02713594|FG000|Participant Flow|Control|Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
11270283|NCT02713594|FG001|Participant Flow|Incentive|"Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit."
11270284|NCT02713594|OG000|Outcome|Control|Counseling from WTQL
11270285|NCT02713594|OG001|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
11270286|NCT02713594|OG000|Outcome|Control|"Counseling from WTQL~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."
10970162|NCT00909181|BG003|Baseline|Total|Total of all reporting groups
10970163|NCT00909181|FG000|Participant Flow|Oxybutynin Gel 56 mg/Day|
10970164|NCT00909181|FG001|Participant Flow|Oxybutynin Gel 84 mg/Day|
11270287|NCT02713594|OG001|Outcome|Incentive|"Counseling from WTQL; Financial incentive to participate~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Financial incentive to participate: Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.)"
11270288|NCT02713594|EG000|Reported Event|Control|Counseling from WTQL
11270289|NCT02713594|EG001|Reported Event|Incentive|Counseling from WTQL; Financial incentive to participate
11270290|NCT02713659|BG000|Baseline|Early Literacy Promotion|Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270291|NCT02713659|BG001|Baseline|Standard Literacy Promotion|Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270292|NCT02713659|BG002|Baseline|Total|Total of all reporting groups
11270293|NCT02713659|FG000|Participant Flow|Early Literacy Promotion|Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270294|NCT02713659|FG001|Participant Flow|Standard Literacy Promotion|Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270295|NCT02713659|OG000|Outcome|Early Literacy Promotion|Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270296|NCT02713659|OG001|Outcome|Standard Literacy Promotion|Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270297|NCT02713659|EG000|Reported Event|Early Literacy Promotion|Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270298|NCT02713659|EG001|Reported Event|Standard Literacy Promotion|Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
11270299|NCT02713698|BG000|Baseline|Group 1 (≥18 Years, BMI<35kg/m2)|Patients with 18 or more years presenting for inpatient nose and ear surgery.
11270300|NCT02713698|BG001|Baseline|Group 2 (≥18 Years, BMI≥35kg/m2)|Patients with 18 or more years presenting for inpatient bariatric surgery.
11270301|NCT02713698|BG002|Baseline|Group 3 (≥65 Years)|Patients with 65 or more years presenting for urgent orthopaedic surgery.
11270302|NCT02713698|BG003|Baseline|Total|Total of all reporting groups
11270303|NCT02713698|FG000|Participant Flow|Group 1 (≥18 Years, BMI<35kg/m2)|Patients with 18 or more years presenting for inpatient nose and ear surgery.
11270304|NCT02713698|FG001|Participant Flow|Group 2 (≥18 Years, BMI≥35kg/m2)|Patients with 18 or more years presenting for inpatient bariatric surgery.
11270305|NCT02713698|FG002|Participant Flow|Group 3 (≥65 Years)|Patients with 65 or more years presenting for urgent orthopaedic surgery.
11270306|NCT02713698|OG000|Outcome|Group 1 (≥18 Years, BMI<35kg/m2)|Patients with 18 or more years presenting for inpatient nose and ear surgery.
11270307|NCT02713698|OG001|Outcome|Group 2 (≥18 Years, BMI≥35kg/m2)|Patients with 18 or more years presenting for inpatient bariatric surgery.
11270308|NCT02713698|OG002|Outcome|Group 3 (≥65 Years)|Patients with 65 or more years presenting for urgent orthopaedic surgery.
11270309|NCT02713698|EG000|Reported Event|Group 1 (≥18 Years, BMI<35kg/m2)|Patients with 18 or more years presenting for inpatient nose and ear surgery.
11270310|NCT02713698|EG001|Reported Event|Group 2 (≥18 Years, BMI≥35kg/m2)|Patients with 18 or more years presenting for inpatient bariatric surgery.
11270311|NCT02713698|EG002|Reported Event|Group 3 (≥65 Years)|Patients with 65 or more years presenting for urgent orthopaedic surgery.
11270312|NCT02713711|BG000|Baseline|All Participants|"Each participant had psoriatic plaques divided into 4 groups.~The control group plaques did not receive any treatment.~Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).~- phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).~Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.~- balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).~Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.~balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments."
11270313|NCT02713711|FG000|Participant Flow|Control Group|The control group plaques did not receive any treatment.
11270314|NCT02713711|FG001|Participant Flow|Phototherapy Group|"Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).~phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED)."
11270315|NCT02713711|FG002|Participant Flow|Balneotherapy|"Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.~balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L)."
11270316|NCT02713711|FG003|Participant Flow|Balneophototherapy|"Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.~balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments."
11270317|NCT02713711|OG000|Outcome|Control Group|The control group plaques did not receive any treatment.
11270318|NCT02713711|OG001|Outcome|Phototherapy Group|"Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).~phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED)."
11270319|NCT02713711|OG002|Outcome|Balneotherapy|"Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.~balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L)."
11270320|NCT02713711|OG003|Outcome|Balneophototherapy|"Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.~balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments."
11270321|NCT02713711|OG000|Outcome|All Participants|14 participants with 58 psoriatic plaques divided into 4 groups.
11270322|NCT02713711|OG000|Outcome|All Participants|14 subjects with 58 psoriatic plaques divided into 4 groups.
11270323|NCT02713711|OG000|Outcome|All Participants|"Each participant had psoriatic plaques divided into 4 groups.~The control group plaques did not receive any treatment.~Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).~- phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).~Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.~- balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).~Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.~balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments."
11270324|NCT02713711|EG000|Reported Event|Control Group|The control group plaques did not receive any treatment.
11270325|NCT02713711|EG001|Reported Event|Phototherapy Group|"Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).~phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED)."
11270326|NCT02713711|EG002|Reported Event|Balneotherapy|"Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.~balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L)."
11270327|NCT02713711|EG003|Reported Event|Balneophototherapy|"Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.~balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments."
11270328|NCT02713789|BG000|Baseline|hMaxi-K 8000 µg|Participants received a single injection of hMaxi-K 8000 micrograms (µg) into the corpus cavernosum of the penis.
11270329|NCT02713789|BG001|Baseline|hMaxi-K 16000 µg|Participants received a single injection of hMaxi-K 16000 µg into the corpus cavernosum of the penis.
11270330|NCT02713789|BG002|Baseline|Placebo|Participants received a single injection of matching placebo (PBS-20% sucrose) into the corpus cavernosum of the penis.
11270331|NCT02713789|BG003|Baseline|Total|Total of all reporting groups
10970165|NCT00909181|FG002|Participant Flow|Placebo Gel|
10970166|NCT00909181|OG000|Outcome|Oxybutynin Gel 56 mg/Day|
10970167|NCT00909181|OG001|Outcome|Oxybutynin Gel 84 mg/Day|
10970168|NCT00909181|OG002|Outcome|Placebo Gel|
10970169|NCT00909181|EG000|Reported Event|Oxybutynin Gel 56 mg/Day|
10970170|NCT00909181|EG001|Reported Event|Oxybutynin Gel 84 mg/Day|
10970171|NCT00909181|EG002|Reported Event|Placebo Gel|
11270332|NCT02713789|FG000|Participant Flow|hMaxi-K 8000 µg|Participants received a single injection of hMaxi-K 8000 micrograms (µg) into the corpus cavernosum of the penis.
11270333|NCT02713789|FG001|Participant Flow|hMaxi-K 16000 µg|Participants received a single injection of hMaxi-K 16000 µg into the corpus cavernosum of the penis.
11270334|NCT02713789|FG002|Participant Flow|Placebo|Participants received a single injection of matching placebo (PBS-20% sucrose) into the corpus cavernosum of the penis.
11270335|NCT02713789|OG000|Outcome|hMaxi-K 8000 µg|Participants received a single injection of hMaxi-K 8000 micrograms (µg) into the corpus cavernosum of the penis.
11270336|NCT02713789|OG001|Outcome|hMaxi-K 16000 µg|Participants received a single injection of hMaxi-K 16000 µg into the corpus cavernosum of the penis.
11270337|NCT02713789|OG002|Outcome|Placebo|Participants received a single injection of matching placebo (PBS-20% sucrose) into the corpus cavernosum of the penis.
11270338|NCT02713789|EG000|Reported Event|hMaxi-K 8000 µg|Participants received a single injection of hMaxi-K 8000 micrograms (µg) into the corpus cavernosum of the penis.
11270339|NCT02713789|EG001|Reported Event|hMaxi-K 16000 µg|Participants received a single injection of hMaxi-K 16000 µg into the corpus cavernosum of the penis.
11270340|NCT02713789|EG002|Reported Event|Placebo|Participants received a single injection of matching placebo (PBS-20% sucrose) into the corpus cavernosum of the penis.
11270341|NCT02713828|BG000|Baseline|Phase I: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle.~Phase I: Glembatumumab Vedotin: Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).~Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs."
11270342|NCT02713828|BG001|Baseline|Phase II: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Maximum Tolerated Dose (MTD) determined in Phase I will be used in Phase II.~Phase II: Glembatumumab Vedotin: In Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients."
11270343|NCT02713828|BG002|Baseline|Total|Total of all reporting groups
11270344|NCT02713828|FG000|Participant Flow|Phase I: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle.~Phase I: Glembatumumab Vedotin: Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).~Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs."
11270345|NCT02713828|FG001|Participant Flow|Phase II: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Maximum Tolerated Dose (MTD) determined in Phase I will be used in Phase II.~Phase II: Glembatumumab Vedotin: In Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients."
11270346|NCT02713828|OG000|Outcome|Phase I: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle.~Phase I: Glembatumumab Vedotin: Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).~Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs."
11270347|NCT02713828|OG000|Outcome|Phase II: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Maximum Tolerated Dose (MTD) determined in Phase I will be used in Phase II.~Phase II: Glembatumumab Vedotin: In Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients."
11270348|NCT02713828|EG000|Reported Event|Phase I: Glembatumumab Vedotin|"Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle.~Phase I: Glembatumumab Vedotin: Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).~Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs."
11270349|NCT02714153|BG000|Baseline|Bridge Occlusion Balloon|"Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.~Bridge Balloon: The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy."
11270350|NCT02714153|FG000|Participant Flow|Bridge Occlusion Balloon|"Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.~Bridge Balloon: The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy."
11270351|NCT02714153|OG000|Outcome|Bridge Occlusion Balloon|"Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.~Bridge Balloon: The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy."
11337602|NCT03588910|FG001|Participant Flow|Half the Number of Oxycodone Tablets Typically Prescribed|"Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11270352|NCT02714153|EG000|Reported Event|Bridge Occlusion Balloon|"Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.~Bridge Balloon: The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy."
11270353|NCT02714283|BG000|Baseline|Inhaled Corticosteroids (ICS)|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists."
11270354|NCT02714283|BG001|Baseline|Macrolide Monotherapy|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded."
11270355|NCT02714283|BG002|Baseline|Total|Total of all reporting groups
11270356|NCT02714283|FG000|Participant Flow|Inhaled Corticosteroids (ICS)|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists."
11270357|NCT02714283|FG001|Participant Flow|Macrolide Monotherapy|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded."
11270358|NCT02714283|OG000|Outcome|Inhaled Corticosteroids (ICS)|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists."
11270359|NCT02714283|OG001|Outcome|Macrolide Monotherapy|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded."
11270360|NCT02714283|OG000|Outcome|Non-CF Bronchiectasis Patients on ICS Monotherapy|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists."
11270361|NCT02714283|OG001|Outcome|Non-CF Bronchiectasis Patients on Macrolide Monotherapy|"New use was defined as the first prescription for a minimum 28 day (chronic) supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded."
11270362|NCT02714283|OG000|Outcome|Non-CF Bronchiectasis Patients on ICS Monotherapy|Patients prescribed a 28 day or more supply of ICS, with an absence of ICS prescriptions for at least the 12 months prior to identified prescription. ICS include beclomethasone, budesonide, flunisolide, fluticasone, mometasone, triamcinolone, ipratropium/albuterol, budesonide/formoterol, or fluticasone/salmeterol. Exclude baseline 28+ day macrolide, missing geographic or socioeconomic data.
11270363|NCT02714283|OG001|Outcome|Non-CF Bronchiectasis Patients on Macrolide Monotherapy|Patients prescribed a 28 day or more supply of a macrolide, with an absence of macrolide prescriptions for at least the 12 months prior to identified prescription. Macrolides include oral azithromycin, clarithromycin, and erythromycin. Exclude baseline 28+ day ICS, missing geographic or socioeconomic data
11270364|NCT02714283|EG000|Reported Event|Non-CF Bronchiectasis Patients on ICS Monotherapy|Patients prescribed a 28 day or more supply of ICS, with an absence of ICS prescriptions for at least the 12 months prior to identified prescription. ICS include beclomethasone, budesonide, flunisolide, fluticasone, mometasone, triamcinolone, ipratropium/albuterol, budesonide/formoterol, or fluticasone/salmeterol. Exclude baseline 28+ day macrolide, missing geographic or socioeconomic data.
11270365|NCT02714283|EG001|Reported Event|Non-CF Bronchiectasis Patients on Macrolide Monotherapy|Patients prescribed a 28 day or more supply of a macrolide, with an absence of macrolide prescriptions for at least the 12 months prior to identified prescription. Macrolides include oral azithromycin, clarithromycin, and erythromycin. Exclude baseline 28+ day ICS, missing geographic or socioeconomic data
11270366|NCT02714400|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11270367|NCT02714400|FG000|Participant Flow|Venlafaxine First, Placebo Second|"50mg of Venlafaxine before sleep first night~1 Pill of Placebo before sleep second night"
11270368|NCT02714400|FG001|Participant Flow|Placebo First, Venlafaxine Second|1 Pill of Placebo before sleep first night 50mg of Venlafaxine before sleep second night
11270369|NCT02714400|OG000|Outcome|Venlafaxine|"50mg of Venlafaxine before sleep~Venlafaxine: Venlafaxine 50mg before sleep"
11270370|NCT02714400|OG001|Outcome|Placebo|"One piece of placebo before sleep~Placebo: One piece of placebo before sleep"
11270371|NCT02714400|EG000|Reported Event|Venlafaxine|"50mg of Venlafaxine before sleep~Venlafaxine: Venlafaxine 50mg before sleep"
11270372|NCT02714400|EG001|Reported Event|Placebo|"One piece of placebo before sleep~Placebo: One piece of placebo before sleep"
11270373|NCT02714426|BG000|Baseline|Brain Health|"Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.~Participants in both interventions receive all study measures equivalently at all occasions"
11270374|NCT02714426|BG001|Baseline|Mindfulness-inspired Treatment/Testing|"Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.~Participants receive all of the same measures as the active comparator Brain Health condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness treatment."
11270375|NCT02714426|BG002|Baseline|Total|Total of all reporting groups
11270376|NCT02714426|FG000|Participant Flow|Brain Health|"Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.~Participants in both interventions receive all study measures equivalently at all occasions"
11270377|NCT02714426|FG001|Participant Flow|Mindfulness-inspired Treatment/Testing|"Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.~Participants receive all of the same measures as the active comparator Brain Health condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment"
11270378|NCT02714426|OG000|Outcome|Brain Health|"Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.~Participants in both interventions receive all study measures equivalently at all occasions"
11270379|NCT02714426|OG001|Outcome|Mindfulness-inspired Treatment/Testing|"Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.~Participants receive all of the same measures as the active comparator Brain Health condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment"
11270380|NCT02714426|EG000|Reported Event|Brain Health|"Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.~Participants in both interventions receive all study measures equivalently at all occasions"
11270381|NCT02714426|EG001|Reported Event|Mindfulness-inspired Treatment/Testing|"Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.~Participants receive all of the same measures as the active comparator Brain Health condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment"
10847344|NCT00282828|OG002|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
10847345|NCT00282828|EG000|Reported Event|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
10847346|NCT00282828|EG001|Reported Event|Venlafaxine|Participants will take venlafaxine only
10847347|NCT00282828|EG002|Reported Event|Sertraline and Placebo|Participants will take both sertraline and placebo
11270382|NCT02714504|BG000|Baseline|Observational|No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
11270383|NCT02714504|BG001|Baseline|Anti-mold Prophylaxis|"Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.~Voriconazole or posaconazole: Azole with activity against molds"
11270384|NCT02714504|BG002|Baseline|Total|Total of all reporting groups
11270385|NCT02714504|FG000|Participant Flow|Observational|No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
11270386|NCT02714504|FG001|Participant Flow|Anti-mold Prophylaxis|"Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.~Voriconazole or posaconazole: Azole with activity against molds"
11270387|NCT02714504|OG000|Outcome|Observational|No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
11270388|NCT02714504|OG001|Outcome|Anti-mold Prophylaxis|"Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.~Voriconazole or posaconazole: Azole with activity against molds"
11270389|NCT02714504|EG000|Reported Event|Observational|No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
11270390|NCT02714504|EG001|Reported Event|Anti-mold Prophylaxis|"Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.~Voriconazole or posaconazole: Azole with activity against molds"
11270391|NCT02714569|BG000|Baseline|Part A, C1, Sequence 1|"1 mg of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.~C1, Sequence 1:~(1 mg LY, 10 mg LY, Placebo, 600 mg LY)"
11092278|NCT01538719|OG001|Outcome|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
11270392|NCT02714569|BG001|Baseline|Part A, C1, Sequence 2|"1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.~C1, Sequence 2:~(1 mg LY, Placebo, 100 mg LY, 600 mg LY)"
11270393|NCT02714569|BG002|Baseline|Part A, C1, Sequence 3|"Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention.~C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)"
11270394|NCT02714569|BG003|Baseline|Part A, C2, Sequence 1|"3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention~C2, Sequence 1:~3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed"
11270395|NCT02714569|BG004|Baseline|Part A, C2, Sequence 2|"3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention.~C2, Sequence 2:~3 mg LY, Placebo, 300 mg LY, Placebo"
11270396|NCT02714569|BG005|Baseline|Part A, C2, Sequence 3|"Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.~C2, Sequence 3:~Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed"
11270397|NCT02714569|BG006|Baseline|Part B: SS/AS/Placebo|Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270398|NCT02714569|BG007|Baseline|Part B: SS/AS/5 mg LY|5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270399|NCT02714569|BG008|Baseline|Part B: SS/AS/20 mg LY|20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270400|NCT02714569|BG009|Baseline|Part B: SS/AS/100 mg LY|100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270401|NCT02714569|BG010|Baseline|Part B: SS/AS/300 mg LY|300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270402|NCT02714569|BG011|Baseline|Total|Total of all reporting groups
11270403|NCT02714569|FG000|Participant Flow|Part A: Cohort 1(C1), Sequence 1|"1 milligram (mg) of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.~C1, Sequence 1: (1 mg LY, 10 mg LY, Placebo, 600 mg LY)"
11270404|NCT02714569|FG001|Participant Flow|Part A: C1, Sequence 2|"1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention.~C1, Sequence 2: (1 mg LY, Placebo, 100 mg LY, 600 mg LY)"
11270405|NCT02714569|FG002|Participant Flow|Part A: C1, Sequence 3|"Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention.~C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)"
11270406|NCT02714569|FG003|Participant Flow|Part A: Cohort 2 (C2), Sequence 1|"3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.~C2, Sequence 1: (3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed)"
11270407|NCT02714569|FG004|Participant Flow|Part A: C2, Sequence 2|"3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention.~C2, Sequence 2: (3 mg LY, Placebo, 300 mg LY, Placebo)"
11270408|NCT02714569|FG005|Participant Flow|Part A: C2, Sequence 3|"Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention.~C2, Sequence 3: (Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed)"
11270409|NCT02714569|FG006|Participant Flow|Part B: C3 (Simvastatin [SS]/Atorvastatin[AS] + 5 mg LY)|5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270410|NCT02714569|FG007|Participant Flow|Part B: C4 (SS/AS + 20 mg LY)|20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270411|NCT02714569|FG008|Participant Flow|Part B: C5 (SS/AS + 100 mg LY)|100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270412|NCT02714569|FG009|Participant Flow|Part B: C6 (SS/AS + 300 mg LY)|300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270413|NCT02714569|FG010|Participant Flow|Part B: C3-C6 (SS/AS + Placebo)|Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270414|NCT02714569|OG000|Outcome|Part A: Placebo|Participants were randomly assigned to placebo instead of LY in one of the first three periods.
11270415|NCT02714569|OG001|Outcome|Part A: 1 mg LY3202328 (LY)|1 mg of LY was taken orally in one of four periods.
11270416|NCT02714569|OG002|Outcome|Part A: 3 mg LY|3 mg of LY was taken orally in one of four periods.
11092279|NCT01538719|EG000|Reported Event|Placebo|"2:1 randomization~Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks"
11270417|NCT02714569|OG003|Outcome|Part A: 10 mg LY|10 mg of LY was taken orally in one of four periods.
11270418|NCT02714569|OG004|Outcome|Part A: 30 mg LY|30 mg of LY was taken orally in one of four periods.
11270419|NCT02714569|OG005|Outcome|Part A: 100 mg LY|100 mg of LY was taken orally in one of four periods.
11270420|NCT02714569|OG006|Outcome|Part A: 300 mg LY|300 mg of LY was taken orally in one of four periods.
11270421|NCT02714569|OG007|Outcome|Part A: 30 mg LY Fed|30 mg (fed) of LY was taken orally in one of four periods.
11270422|NCT02714569|OG008|Outcome|Part A: 600 mg LY|600 mg of LY was taken orally in one of four periods.
11270423|NCT02714569|OG009|Outcome|Part B: SS/AS/Placebo|Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270424|NCT02714569|OG010|Outcome|Part B: SS/AS/5 mg of LY|5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270425|NCT02714569|OG011|Outcome|Part B: SS/AS/20 mg of LY|20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270426|NCT02714569|OG012|Outcome|Part B: SS/AS/100 mg of LY|100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270427|NCT02714569|OG013|Outcome|Part B: SS/AS/300 mg of LY|300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270428|NCT02714569|OG000|Outcome|Part A: 1 mg LY|1 mg of LY was taken orally in one of four periods.
11270429|NCT02714569|OG001|Outcome|Part A: 3 mg LY|3 mg of LY was taken orally in one of four periods.
11270430|NCT02714569|OG002|Outcome|Part A: 10 mg LY|10 mg of LY was taken orally in one of four periods.
11270431|NCT02714569|OG003|Outcome|Part A: 30 mg LY|30 mg of LY was taken orally in one of four periods.
11270432|NCT02714569|OG004|Outcome|Part A: 100 mg LY|100 mg of LY was taken orally in one of four periods.
11270433|NCT02714569|OG005|Outcome|Part A: 300 mg LY|300 mg of LY was taken orally in one of four periods.
11270434|NCT02714569|OG006|Outcome|Part A: 600 mg LY|600 mg of LY was taken orally in one of four periods.
11270435|NCT02714569|OG007|Outcome|Part A: 30 mg LY Fed|30 mg of LY (fed) was taken orally in one of four periods.
11270436|NCT02714569|OG000|Outcome|Part B: 5 mg LY|5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270437|NCT02714569|OG001|Outcome|Part B: 20 mg LY|20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270438|NCT02714569|OG002|Outcome|Part B: 100 mg LY|100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270439|NCT02714569|OG003|Outcome|Part B: 300 mg LY|300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270440|NCT02714569|OG001|Outcome|Part A: 3 mg of LY|3 mg of LY was taken orally in one of four periods.
11270441|NCT02714569|OG004|Outcome|Part A: 100 mg of LY|100 mg of LY was taken orally in one of four periods.
11270442|NCT02714569|OG007|Outcome|Part A: 30 mg LY Fed|30 mg of LY was taken orally in one of four periods.
11270443|NCT02714569|OG002|Outcome|Part A: 10 mg LY|10 mg of LY or placebo was taken orally in one of four periods.
11270444|NCT02714569|OG001|Outcome|Part A: 1 mg LY|1 mg of LY was taken orally in one of four periods.
11270445|NCT02714569|OG007|Outcome|Part A: 600 mg LY|600 mg of LY was taken orally in one of four periods..
11270446|NCT02714569|OG000|Outcome|Part B: Placebo|A multiple ascending dose of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270447|NCT02714569|OG001|Outcome|Part B: 5 mg LY|5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270448|NCT02714569|OG002|Outcome|Part B: 20 mg LY|20 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270449|NCT02714569|OG003|Outcome|Part B: 100 mg LY|100 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270450|NCT02714569|OG004|Outcome|Part B: 300 mg LY|300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) week prior to treatment and on Day 29.
11270451|NCT02714569|OG007|Outcome|Part A: 600 mg LY|600 mg of LY was taken orally in one of four periods.
11270452|NCT02714569|OG004|Outcome|Part B: 300 mg LY|300 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270453|NCT02714569|OG000|Outcome|Part B: Placebo|A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270454|NCT02714569|OG003|Outcome|Part A: 10 mg LY|10 mg of LY was taken orally in one of four periods..
11270455|NCT02714569|OG000|Outcome|Part B: Placebo|Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270456|NCT02714569|OG004|Outcome|Part B: 300 mg LY|5 mg of LY taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
11270457|NCT02714569|OG000|Outcome|Simvastatin With LY (Test)|A single simvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
11270458|NCT02714569|OG001|Outcome|Simvastatin Alone (Reference)|A single simvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
11270459|NCT02714569|OG000|Outcome|Atorvastatin With LY (Test)|A single atorvastatin test dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing (coadministered with LY).
11270460|NCT02714569|OG001|Outcome|Atorvastatin Alone (Reference)|A single atorvastatin reference dose was taken fasted a week prior to LY treatment initiation, and on Day 29 after initiation of LY daily dosing without LY.
11270461|NCT02714569|EG000|Reported Event|Placebo|Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
11270462|NCT02714569|EG001|Reported Event|1 mg LY3202328 (LY)|1 mg of LY was taken orally in one of four periods in Part A.
11270463|NCT02714569|EG002|Reported Event|3 mg LY|3 mg of LY was taken orally in one of four periods in Part A.
11270464|NCT02714569|EG003|Reported Event|5 mg LY|5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
11270465|NCT02714569|EG004|Reported Event|10 mg LY|10 mg of LY was taken orally in one of four periods in Part A.
11270466|NCT02714569|EG005|Reported Event|20 mg LY|20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
11270467|NCT02714569|EG006|Reported Event|30 mg LY|30 mg of LY was taken orally in one of four periods in Part A.
11270468|NCT02714569|EG007|Reported Event|30 mg LY Fed|30 mg of LY (fed) was taken orally in one of four periods in Part A.
11270469|NCT02714569|EG008|Reported Event|100 mg LY|100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
11270470|NCT02714569|EG009|Reported Event|300 mg LY|300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
11270471|NCT02714569|EG010|Reported Event|600 mg of LY|600 mg of LY was taken orally in one of four periods in Part A.
11270472|NCT02714595|BG000|Baseline|Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270473|NCT02714595|BG001|Baseline|Best Available Therapy (BAT)|Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270474|NCT02714595|BG002|Baseline|Total|Total of all reporting groups
11270475|NCT02714595|FG000|Participant Flow|Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270476|NCT02714595|FG001|Participant Flow|Best Available Therapy (BAT)|Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270477|NCT02714595|OG000|Outcome|HAP/VAP/HCAP: Cefiderocol|Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270478|NCT02714595|OG001|Outcome|HAP/VAP/HCAP: Best Available Therapy|Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270479|NCT02714595|OG002|Outcome|BSI/Sepsis: Cefiderocol|Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270480|NCT02714595|OG003|Outcome|BSI/Sepsis: Best Available Therapy|Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270481|NCT02714595|OG000|Outcome|cUTI: Cefiderocol|Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270482|NCT02714595|OG001|Outcome|cUTI: Best Available Therapy|Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270483|NCT02714595|OG000|Outcome|HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol|Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270484|NCT02714595|OG001|Outcome|HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy|Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270485|NCT02714595|OG002|Outcome|Overall: Cefiderocol|Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270486|NCT02714595|OG003|Outcome|Overall: Best Available Therapy|Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270487|NCT02714595|OG004|Outcome|cUTI: Cefiderocol|Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270488|NCT02714595|OG005|Outcome|cUTI: Best Available Therapy|Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270489|NCT02714595|OG006|Outcome|HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol|Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270490|NCT02714595|OG007|Outcome|HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy|Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270491|NCT02714595|OG008|Outcome|Overall: Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270492|NCT02714595|OG009|Outcome|Overall: Best Available Therapy|Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270493|NCT02714595|OG000|Outcome|Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270494|NCT02714595|OG001|Outcome|Best Available Therapy (BAT)|Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270495|NCT02714595|OG006|Outcome|Overall: Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270496|NCT02714595|OG007|Outcome|Overall: Best Available Therapy|Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270497|NCT02714595|EG000|Reported Event|Cefiderocol|Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.
11270498|NCT02714595|EG001|Reported Event|Best Available Therapy (BAT)|Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
11270499|NCT02714868|BG000|Baseline|Project TEAM Intervention|"Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.~Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal."
11270500|NCT02714868|BG001|Baseline|Matched Comparison|"Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.~Matched Comparison: Participants set goal to try a new activity in the community"
11270501|NCT02714868|BG002|Baseline|Total|Total of all reporting groups
11337603|NCT03588910|OG000|Outcome|Number of Oxycodone Tablets Typically Prescribed|"Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11270502|NCT02714868|FG000|Participant Flow|Project TEAM Intervention|"Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.~Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal."
11270503|NCT02714868|FG001|Participant Flow|Matched Comparison|"Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.~Matched Comparison: Participants set goal to try a new activity in the community"
11270504|NCT02714868|OG000|Outcome|Project TEAM Intervention|"Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.~Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal."
11270505|NCT02714868|OG001|Outcome|Matched Comparison|"Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.~Matched Comparison: Participants set goal to try a new activity in the community"
11270506|NCT02714868|OG000|Outcome|Project TEAM Intervention|Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes are to: increase youths' knowledge of environmental factors and modification strategies; reduce the impact of environmental barriers on participation; increase self-efficacy and self-determination; and increase participation in a personal activity goal in the area of education, employment, or community life.
11270507|NCT02714868|EG000|Reported Event|Project TEAM Intervention|"Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.~Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential"
11270508|NCT02714868|EG001|Reported Event|Matched Comparison|"Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.~Matched Comparison: Participants set goal to try a new activity in the community"
11270509|NCT02715076|BG000|Baseline|Ambient Temp 19°C & Passive Insulation|"Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 19°C: Ambient Temperature 19°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270510|NCT02715076|BG001|Baseline|Ambient Temp 19°C & Forced-air Warming|"Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 19°C: Ambient Temperature 19°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270511|NCT02715076|BG002|Baseline|Ambient Temp 21°C & Passive Insulation|"Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 21°C: Ambient Temperature 21°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270512|NCT02715076|BG003|Baseline|Ambient Temp 21°C & Forced-air Warming|"Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 21°C: Ambient Temperature 21°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11092280|NCT01538719|EG001|Reported Event|Rilonacept|"2:1 randomization~Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks"
11092281|NCT01538745|BG000|Baseline|Ketamine|"0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.~Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses."
11092282|NCT01538745|BG001|Baseline|Morphine|"0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.~Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses."
11270513|NCT02715076|BG004|Baseline|Ambient Temp 23°C & Passive Insulation|"Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 23°C: Ambient Temperature 23°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270514|NCT02715076|BG005|Baseline|Ambient Temp 23°C & Forced-air Warming|"Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 23°C: Ambient Temperature 23°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270515|NCT02715076|BG006|Baseline|Total|Total of all reporting groups
11270516|NCT02715076|FG000|Participant Flow|Ambient Temp 19°C & Passive Insulation|"Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 19°C: Ambient Temperature 19°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270517|NCT02715076|FG001|Participant Flow|Ambient Temp 19°C & Forced-air Warming|"Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 19°C: Ambient Temperature 19°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270518|NCT02715076|FG002|Participant Flow|Ambient Temp 21°C & Passive Insulation|"Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 21°C: Ambient Temperature 21°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270519|NCT02715076|FG003|Participant Flow|Ambient Temp 21°C & Forced-air Warming|"Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 21°C: Ambient Temperature 21°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270520|NCT02715076|FG004|Participant Flow|Ambient Temp 23°C & Passive Insulation|"Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 23°C: Ambient Temperature 23°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270521|NCT02715076|FG005|Participant Flow|Ambient Temp 23°C & Forced-air Warming|"Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 23°C: Ambient Temperature 23°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270522|NCT02715076|OG000|Outcome|Ambient Temp 19°C & Passive Insulation|"Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 19°C: Ambient Temperature 19°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270523|NCT02715076|OG001|Outcome|Ambient Temp 19°C & Forced-air Warming|"Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 19°C: Ambient Temperature 19°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270524|NCT02715076|OG002|Outcome|Ambient Temp 21°C & Passive Insulation|"Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 21°C: Ambient Temperature 21°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270525|NCT02715076|OG003|Outcome|Ambient Temp 21°C & Forced-air Warming|"Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 21°C: Ambient Temperature 21°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270526|NCT02715076|OG004|Outcome|Ambient Temp 23°C & Passive Insulation|"Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 23°C: Ambient Temperature 23°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270527|NCT02715076|OG005|Outcome|Ambient Temp 23°C & Forced-air Warming|"Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 23°C: Ambient Temperature 23°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270528|NCT02715076|EG000|Reported Event|Ambient Temp 19°C & Passive Insulation|"Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 19°C: Ambient Temperature 19°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11270529|NCT02715076|EG001|Reported Event|Ambient Temp 19°C & Forced-air Warming|"Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 19°C: Ambient Temperature 19°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270530|NCT02715076|EG002|Reported Event|Ambient Temp 21°C & Passive Insulation|"Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 21°C: Ambient Temperature 21°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11092283|NCT01538745|BG002|Baseline|Total|Total of all reporting groups
11270531|NCT02715076|EG003|Reported Event|Ambient Temp 21°C & Forced-air Warming|"Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 21°C: Ambient Temperature 21°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270532|NCT02715076|EG004|Reported Event|Ambient Temp 23°C & Passive Insulation|"Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.~Ambient Temperature 23°C: Ambient Temperature 23°C~Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping."
11092284|NCT01538745|FG000|Participant Flow|Ketamine|"0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.~Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses."
11270533|NCT02715076|EG005|Reported Event|Ambient Temp 23°C & Forced-air Warming|"Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.~Ambient Temperature 23°C: Ambient Temperature 23°C~Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface."
11270534|NCT02715258|BG000|Baseline|Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
11270535|NCT02715258|BG001|Baseline|Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
11270536|NCT02715258|BG002|Baseline|Total|Total of all reporting groups
11270537|NCT02715258|FG000|Participant Flow|Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
11270538|NCT02715258|FG001|Participant Flow|Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
11270539|NCT02715258|OG000|Outcome|Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
11270540|NCT02715258|OG001|Outcome|Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
11270541|NCT02715258|EG000|Reported Event|Bexagliflozin Tablets, 20 mg|Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks.
11270542|NCT02715258|EG001|Reported Event|Placebo Tablets|Each subject was to take placebo (inactive tablet) once daily for 24 weeks.
11270543|NCT02715700|BG000|Baseline|Maintenance Methadone + Doravirine|Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Days 1 to 7 and doravirine 100 mg on Days 2 to 6.
11270544|NCT02715700|FG000|Participant Flow|Maintenance Methadone + Doravirine|Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Days 1 to 7 and doravirine 100 mg on Days 2 to 6.
11270545|NCT02715700|OG000|Outcome|Maintenance Methadone|Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
11270546|NCT02715700|OG001|Outcome|Maintenance Methadone + Doravirine|Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
11270547|NCT02715700|EG000|Reported Event|Maintenance Methadone (Day 1)|Participants received the methadone maintenance dose on Day 1.
11270548|NCT02715700|EG001|Reported Event|Maintenance Methadone + Doravirine (Days 2 to 6)|Participants received the methadone maintenance dose and doravirine 100 mg on Days 2 to 6.
11270549|NCT02715700|EG002|Reported Event|Maintenance Methadone (Day 7)|Participants received the maintenance methadone dose on Day 7.
11270550|NCT02715700|EG003|Reported Event|Safety Follow-Up (Days 8 to 21)|Participants were monitored for safety for 14 days after the final dose of study treatment.
11270551|NCT02715726|BG000|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
11270552|NCT02715726|BG001|Baseline|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
11270553|NCT02715726|BG002|Baseline|Total|Total of all reporting groups
11270554|NCT02715726|FG000|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule once daily with or without food for 24 Weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT).
11270555|NCT02715726|FG001|Participant Flow|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) level was >=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]) at Week 8.
11270556|NCT02715726|OG000|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
11270557|NCT02715726|OG001|Outcome|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
11270558|NCT02715726|EG000|Reported Event|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
11270559|NCT02715726|EG001|Reported Event|Alirocumab 75 mg Q2W/up150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
11270560|NCT02715804|BG000|Baseline|PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine|Participants received 3.0 μg/kg PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisted of 4 weeks [Week 4 of every cycle was a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 150.1 weeks).
11270561|NCT02715804|BG001|Baseline|AG: Placebo + Nab-Paclitaxel + Gemcitabine|Participants received placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 83.9 weeks).
11270562|NCT02715804|BG002|Baseline|Total|Total of all reporting groups
11270563|NCT02715804|FG000|Participant Flow|PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine|Participants received 3.0 micrograms/kilogram (μg/kg) PEGPH20 as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisted of 4 weeks [Week 4 of every cycle was a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 milligrams/square meter (mg/m^2) nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 150.1 weeks).
11270564|NCT02715804|FG001|Participant Flow|AG: Placebo + Nab-Paclitaxel + Gemcitabine|Participants received placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 83.9 weeks).
11270565|NCT02715804|OG000|Outcome|PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine|Participants received 3.0 μg/kg PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisted of 4 weeks [Week 4 of every cycle was a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 150.1 weeks).
11270566|NCT02715804|OG001|Outcome|AG: Placebo + Nab-Paclitaxel + Gemcitabine|Participants received placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 83.9 weeks).
11270567|NCT02715804|EG000|Reported Event|PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine|Participants received 3.0 μg/kg PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisted of 4 weeks [Week 4 of every cycle was a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 150.1 weeks).
11270568|NCT02715804|EG001|Reported Event|AG: Placebo + Nab-Paclitaxel + Gemcitabine|Participants received placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continue until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 83.9 weeks).
11270569|NCT02716194|BG000|Baseline|Cohort 1 - Low Dose|Participants were to receive an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270570|NCT02716194|BG001|Baseline|Cohort 2 - Medium Dose|After data from Cohort 1 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270571|NCT02716194|BG002|Baseline|Cohort 3 - High Dose|After data from Cohort 2 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 75±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270572|NCT02716194|BG003|Baseline|Total|Total of all reporting groups
11270573|NCT02716194|FG000|Participant Flow|Cohort 1 - Low Dose|Participants were to receive an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270574|NCT02716194|FG001|Participant Flow|Cohort 2 - Medium Dose|After data from Cohort 1 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270575|NCT02716194|FG002|Participant Flow|Cohort 3 - High Dose|After data from Cohort 2 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 75±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270576|NCT02716194|OG000|Outcome|Cohort 1 - Low Dose|Participants were to receive an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270577|NCT02716194|OG001|Outcome|Cohort 2 - Medium Dose|After data from Cohort 1 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270578|NCT02716194|OG002|Outcome|Cohort 3 - High Dose|After data from Cohort 2 have been reviewed and approved by an internal Safety Monitoring Committee, participants were to receive an infusion of 75±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. Following the washout period, participants were to receive a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270579|NCT02716194|OG000|Outcome|Cohort 1 - Low Dose|The study is comprised of 3 dose cohorts and two dose escalation steps [Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level.
11270580|NCT02716194|OG001|Outcome|Cohort 2 - Medium Dose|The study is comprised of 3 dose cohorts and two dose escalation steps [Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level.
11270581|NCT02716194|OG002|Outcome|Cohort 3 - High Dose|The study is comprised of 3 dose cohorts and two dose escalation steps [Cohort 1: 10 evaluable participants; Cohort 2: 10 evaluable participants; Cohort 3: 10 evaluable participants]. Participants will be recruited to the next dose level only after short-term safety has been reviewed and subject to approval by a Safety Review Committee at the preceding dose level.
11270582|NCT02716194|OG000|Outcome|Cohort 1 - Low Dose ADVATE|Participants received an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270583|NCT02716194|OG001|Outcome|Cohort 2 - Medium Dose ADVATE|Participants received an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270584|NCT02716194|OG002|Outcome|Cohort 3 - High Dose ADVATE|Participants received an infusion of 75±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270585|NCT02716194|OG003|Outcome|Cohort 1 - Low Dose BAX 826|After the 4 day washout period following the infusion of 25±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270586|NCT02716194|OG004|Outcome|Cohort 2 - Medium Dose BAX 826|After the washout period following the infusion of 50±5 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270587|NCT02716194|OG005|Outcome|Cohort 3 - High Dose BAX 826|After the washout period following the infusion of 75±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270588|NCT02716194|OG000|Outcome|Pharmacokinetic Analysis Data Set|The PK analysis set includes all participants that underwent pharmacokinetic assessments.
11270589|NCT02716194|EG000|Reported Event|Cohort 1 - Low Dose ADVATE|Participants received an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270590|NCT02716194|EG001|Reported Event|Cohort 2 - Medium Dose ADVATE|Participants received an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270591|NCT02716194|EG002|Reported Event|Cohort 3 - High Dose ADVATE|Participants received an infusion of 75±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation.
11270592|NCT02716194|EG003|Reported Event|Cohort 1 - Low Dose BAX 826|After the 4 day washout period following the infusion of 25±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270593|NCT02716194|EG004|Reported Event|Cohort 2 - Medium Dose BAX 826|After the washout period following the infusion of 50±5 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270594|NCT02716194|EG005|Reported Event|Cohort 3 - High Dose BAX 826|After the washout period following the infusion of 75±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation.
11270595|NCT02716298|BG000|Baseline|Overall Participants|"Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
11270596|NCT02716298|FG000|Participant Flow|Fanfilcon A Then Lotrafilcon B|"Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
11270597|NCT02716298|FG001|Participant Flow|Lotrafilcon B Then Fanfilcon A|"Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.~lotrafilcon B: contact lens fanfilcon A: contact lens"
11270598|NCT02716298|OG000|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
11270599|NCT02716298|OG001|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
11270600|NCT02716298|OG000|Outcome|Strongly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
11270601|NCT02716298|OG001|Outcome|Slightly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
11270602|NCT02716298|OG002|Outcome|No Preference|
11270603|NCT02716298|OG003|Outcome|Slightly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
11270604|NCT02716298|OG004|Outcome|Strongly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
11270605|NCT02716298|EG000|Reported Event|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens during the crossover study~fanfilcon A: contact lens"
11270606|NCT02716298|EG001|Reported Event|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens during the crossover study.~lotrafilcon B: contact lens"
11270607|NCT02716324|BG000|Baseline|ADHD Portal|"In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.~ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool."
11270608|NCT02716324|BG001|Baseline|ADHD Portal Plus Care Manager|"In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal.~Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment.~ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment."
11270609|NCT02716324|BG002|Baseline|Total|Total of all reporting groups
11270610|NCT02716324|FG000|Participant Flow|ADHD Portal|"In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.~ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool."
11270611|NCT02716324|FG001|Participant Flow|ADHD Portal Plus Care Manager|"In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal.~Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment.~ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment."
11270612|NCT02716324|OG000|Outcome|ADHD Portal|"In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.~ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool."
11270613|NCT02716324|OG001|Outcome|ADHD Portal Plus Care Manager|"In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal.~Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment.~ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment."
11286820|NCT02894502|BG000|Baseline|Motivational Interviewing Only for Patients|"In this arm the interventions will be delivered only to patients~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11092285|NCT01538745|FG001|Participant Flow|Morphine|"0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.~Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses."
11092286|NCT01538745|OG000|Outcome|Ketamine|"0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.~Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses."
11270614|NCT02716324|EG000|Reported Event|ADHD Portal|"In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.~ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool."
11270615|NCT02716324|EG001|Reported Event|ADHD Portal Plus Care Manager|"In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal.~Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment.~ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment."
11270616|NCT02716506|BG000|Baseline|Symptomatic POP|Patients that were operated for POP in 2015 in Finland and participated the study
11270617|NCT02716506|FG000|Participant Flow|Symptomatic POP|"POP surgery in year 2015~POP surgery: Any surgical procedure that is done to treat the symptomatic POP"
11270618|NCT02716506|OG000|Outcome|Symptomatic POP|"POP surgery in year 2015~POP surgery: Any surgical procedure that is done to treat the symptomatic POP"
11270619|NCT02716506|EG000|Reported Event|Symptomatic POP|"POP surgery in year 2015~POP surgery: Any surgical procedure that is done to treat the symptomatic POP"
11270620|NCT02716584|BG000|Baseline|Physical Exercise|"Participants participate in brisk walking exercises.~Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age)."
11270621|NCT02716584|BG001|Baseline|Stretching Exercise|"Participants participate in non-aerobic, non-Yoga stretching exercises~Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week."
11270622|NCT02716584|BG002|Baseline|Total|Total of all reporting groups
11270623|NCT02716584|FG000|Participant Flow|Physical Exercise|"Participants participate in brisk walking exercises.~Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age)."
11270624|NCT02716584|FG001|Participant Flow|Stretching Exercise|"Participants participate in non-aerobic, non-Yoga stretching exercises~Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week."
11270625|NCT02716584|OG000|Outcome|Physical Exercise|"Participants participate in brisk walking exercises.~Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age)."
11270626|NCT02716584|OG001|Outcome|Stretching Exercise|"Participants participate in non-aerobic, non-Yoga stretching exercises~Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week."
11270627|NCT02716584|EG000|Reported Event|Physical Exercise|"Participants participate in brisk walking exercises.~Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age)."
11270628|NCT02716584|EG001|Reported Event|Stretching Exercise|"Participants participate in non-aerobic, non-Yoga stretching exercises~Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week."
11270629|NCT02716714|BG000|Baseline|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270630|NCT02716714|BG001|Baseline|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270631|NCT02716714|BG002|Baseline|Total|Total of all reporting groups
11270632|NCT02716714|FG000|Participant Flow|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270633|NCT02716714|FG001|Participant Flow|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270634|NCT02716714|OG000|Outcome|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270635|NCT02716714|OG001|Outcome|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270636|NCT02716714|OG000|Outcome|CC Group|The participants who achieved complete clearance of AK lesions in the selected treatment.
11270637|NCT02716714|OG001|Outcome|Non-CC Group|The participants who didn't achieved complete clearance of AK lesions in the selected treatment.
11270638|NCT02716714|OG000|Outcome|CC Group|The participants who achieved complete clearance of AK lesions in the selected treatment and the CC group of Ingenol Mebutate Gel 0.015% and 0.05% was intended to be analyzed together.
11270639|NCT02716714|OG001|Outcome|Non-CC Group|The participants who didn't achieved complete clearance of AK lesions in the selected treatment and the Non-CC group of Ingenol Mebutate Gel 0.015% and 0.05% was intended to be analyzed together.
11270640|NCT02716714|EG000|Reported Event|Ingenol Mebutate Gel 0.015%|"Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270641|NCT02716714|EG001|Reported Event|Ingenol Mebutate Gel 0.05%|"Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.~1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area."
11270642|NCT02716727|BG000|Baseline|Aquasil Ultra Cordless, Dentsply|"Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.~Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure"
11270643|NCT02716727|BG001|Baseline|Ultrapak, Ultradent Cord|"The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement.~Ultrapak, Ultradent cord: Cordless gingival displacement procedure"
11270644|NCT02716727|BG002|Baseline|Total|Total of all reporting groups
11270645|NCT02716727|FG000|Participant Flow|Aquasil Ultra Cordless, Dentsply|"Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.~Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure"
11270646|NCT02716727|FG001|Participant Flow|Ultrapak, Ultradent Cord|"The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement.~Ultrapak, Ultradent cord: Cordless gingival displacement procedure"
11270647|NCT02716727|OG000|Outcome|Aquasil Ultra Cordless, Dentsply|"Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.~Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure"
11270648|NCT02716727|OG001|Outcome|Ultrapak, Ultradent Cord|"The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement.~Ultrapak, Ultradent cord: Cordless gingival displacement procedure"
11270649|NCT02716727|EG000|Reported Event|Aquasil Ultra Cordless, Dentsply|"Gingival displacement procedure that uses a pneumatic hand piece to inject the light body impression material into the gingival sulcus.~Aquasil Ultra Cordless, Dentsply: Cordless gingival displacement procedure"
11270650|NCT02716727|EG001|Reported Event|Ultrapak, Ultradent Cord|"The knitted cord is used for physical displacement of gingival tissue. Cord is placed in the gingival sulcus and left in place for at least 4 minutes to achieve gingival displacement.~Ultrapak, Ultradent cord: Cordless gingival displacement procedure"
11270651|NCT02716779|BG000|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270652|NCT02716779|BG001|Baseline|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270653|NCT02716779|BG002|Baseline|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270654|NCT02716779|BG003|Baseline|Total|Total of all reporting groups
11270655|NCT02716779|FG000|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270656|NCT02716779|FG001|Participant Flow|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270657|NCT02716779|FG002|Participant Flow|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270658|NCT02716779|OG000|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270659|NCT02716779|OG001|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270660|NCT02716779|OG002|Outcome|Total Participant Group|Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
11335719|NCT03555266|FG001|Participant Flow|Sham NSS-2 BRIDGE and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol~Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol."
11092287|NCT01538745|OG001|Outcome|Morphine|"0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.~Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses."
11270661|NCT02716779|OG001|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270662|NCT02716779|OG002|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270663|NCT02716779|OG001|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
11270664|NCT02716779|EG000|Reported Event|PEG-IFN Alfa-2a, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks."
11270665|NCT02716779|EG001|Reported Event|Placebo, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks."
11270666|NCT02716779|EG002|Reported Event|Ribavirin, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
11270667|NCT02716779|EG003|Reported Event|PEG-IFN Alfa-2a, Period 2 Combination Therapy|"In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
11270668|NCT02716779|EG004|Reported Event|Placebo, Period 2 Combination Therapy|"In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
11270669|NCT02716779|EG005|Reported Event|Ribavirin, Period 2 Combination Therapy|"In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
11335720|NCT03555266|OG000|Outcome|NSS-2 Bridge and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol."
11092288|NCT01538745|EG000|Reported Event|Ketamine|"0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.~Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses."
11092289|NCT01538745|EG001|Reported Event|Morphine|"0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.~Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses."
11092290|NCT01538862|BG000|Baseline|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
11270670|NCT02716805|BG000|Baseline|Cohort 1|"Late post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270671|NCT02716805|FG000|Participant Flow|Cohort 1|"Late post-autologous stem cell transplant (ASCT) treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270672|NCT02716805|FG001|Participant Flow|Cohort 2|"Early post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270673|NCT02716805|FG002|Participant Flow|Cohort 3|"Late post-ASCT treatment (tremelimumab + durvalumab in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270674|NCT02716805|FG003|Participant Flow|Cohort 4|"Early post-ASCT treatment (tremelimumab + durvalumab in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270675|NCT02716805|OG000|Outcome|Cohort 1|"Late post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270676|NCT02716805|EG000|Reported Event|Cohort 1|"Late post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)"
11270677|NCT02716818|BG000|Baseline|Chronocort®|"Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subjects previous glucocorticoid therapy dose and then dose titrated to effect.~Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol."
11270678|NCT02716818|BG001|Baseline|Standard Glucocorticoid Therapy|"Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of:~Hydrocortisone only~Prednisone or prednisolone, alone or in combination with hydrocortisone~Dexamethasone, alone or in combination with any other glucocorticoid"
11270679|NCT02716818|BG002|Baseline|Total|Total of all reporting groups
11270680|NCT02716818|FG000|Participant Flow|Chronocort®|"Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subject's previous glucocorticoid therapy dose and then dose titrated to effect.~Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol."
11092291|NCT01538862|FG000|Participant Flow|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
11092292|NCT01538862|OG000|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
11270681|NCT02716818|FG001|Participant Flow|Standard Glucocorticoid Therapy|"Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of:~Hydrocortisone only~Prednisone or prednisolone, alone or in combination with hydrocortisone~Dexamethasone, alone or in combination with any other glucocorticoid"
11270682|NCT02716818|OG000|Outcome|Chronocort®|"Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subjects previous glucocorticoid therapy dose and then dose titrated to effect.~Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol."
11270683|NCT02716818|OG001|Outcome|Standard Glucocorticoid Therapy|"Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of:~Hydrocortisone only~Prednisone or prednisolone, alone or in combination with hydrocortisone~Dexamethasone, alone or in combination with any other glucocorticoid"
11270684|NCT02716818|OG000|Outcome|Pre-Baseline - Hydrocortisone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270685|NCT02716818|OG001|Outcome|Pre-Baseline - Prednisone/Prednisolone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270686|NCT02716818|OG002|Outcome|Pre-Baseline - Dexamethasone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270687|NCT02716818|OG003|Outcome|Pre-Baseline - Chronocort vs. Hydrocortisone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270688|NCT02716818|OG004|Outcome|Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270689|NCT02716818|OG005|Outcome|Pre-Baseline - Chronocort vs. Dexamethasone - 17-OHP|Secondary efficacy analysis of 17-OHP by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set).
11270690|NCT02716818|OG006|Outcome|Pre-Baseline - Hydrocortisone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270691|NCT02716818|OG007|Outcome|Pre-Baseline - Prednisone/Prednisolone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270692|NCT02716818|OG008|Outcome|Pre-Baseline - Dexamethasone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270693|NCT02716818|OG009|Outcome|Pre-Baseline - Chronocort vs. Hydrocortisone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270694|NCT02716818|OG010|Outcome|Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270695|NCT02716818|OG011|Outcome|Pre-Baseline - Chronocort vs. Dexamethasone - A4|Secondary efficacy analysis of A4 by pre-treatment strata, change from baseline to 24 weeks in primary efficacy variable, analysis of covariance model (Efficacy evaluable analysis set)
11270696|NCT02716818|OG000|Outcome|Chronocort - 09:00h Response - 17-OHP|Number of participants in the Chronocort arm (from the efficacy evaluable analysis set) achieving 17-OHP levels within the optimal range expected at 09:00h at the week 24 visit.
11270697|NCT02716818|OG001|Outcome|Chronocort - 09:00h Response - A4|Number of participants in the Chronocort arm (from the efficacy evaluable analysis set) achieving A4 levels within the optimal range expected at 09:00h at the week 24 visit.
11270698|NCT02716818|OG002|Outcome|Standard Glucocorticoid Therapy - 09:00h Response - 17-OHP|Number of participants in the standard glucocorticoid arm (from the efficacy evaluable analysis set) achieving 17-OHP levels within the optimal range expected at 09:00h at the week 24 visit.
11270699|NCT02716818|OG003|Outcome|Standard Glucocorticoid Therapy - 09:00h Response - A4|Number of participants in the standard glucocorticoid arm (from the efficacy evaluable analysis set) achieving A4 levels within the optimal range expected at 09:00h at the week 24 visit.
11270700|NCT02716818|OG000|Outcome|Chronocort - DEXA - Fat Mass|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270701|NCT02716818|OG001|Outcome|Standard Glucocorticoid Therapy - DEXA - Fat Mass|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270702|NCT02716818|OG002|Outcome|Chronocort - DEXA - Lean Mass|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270703|NCT02716818|OG003|Outcome|Standard Glucocorticoid Therapy - DEXA - Lean Mass|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270704|NCT02716818|OG000|Outcome|Chronocort - DEXA - Bone Mineral Density|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270705|NCT02716818|OG001|Outcome|Standard Glucocorticoid Therapy - DEXA - Bone Mineral Density|German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.
11270706|NCT02716818|EG000|Reported Event|Chronocort®|"Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subjects previous glucocorticoid therapy dose and then dose titrated to effect.~Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol."
11270707|NCT02716818|EG001|Reported Event|Standard Glucocorticoid Therapy|"Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of:~Hydrocortisone only~Prednisone or prednisolone, alone or in combination with hydrocortisone~Dexamethasone, alone or in combination with any other glucocorticoid"
11270708|NCT02716896|BG000|Baseline|Surgery (Radical Cystectomy)|"In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen.~Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group."
11270709|NCT02716896|BG001|Baseline|Radiation and Chemoradiation|"Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen.~Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group."
11270710|NCT02716896|BG002|Baseline|Total|Total of all reporting groups
11270711|NCT02716896|FG000|Participant Flow|Surgery (Radical Cystectomy)|"In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen.~Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group."
11270712|NCT02716896|FG001|Participant Flow|Radiation and Chemoradiation|"Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen.~Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group."
11270713|NCT02716896|OG000|Outcome|Surgery (Radical Cystectomy)|"In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen.~Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group."
11270714|NCT02716896|OG001|Outcome|Radiation and Chemoradiation|"Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen.~Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group."
11270715|NCT02716896|EG000|Reported Event|Surgery (Radical Cystectomy)|"In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen.~Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group."
11270716|NCT02716896|EG001|Reported Event|Radiation and Chemoradiation|"Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen.~Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group."
11270717|NCT02716987|BG000|Baseline|Set A: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270718|NCT02716987|BG001|Baseline|Set A: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270719|NCT02716987|BG002|Baseline|Set A: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270720|NCT02716987|BG003|Baseline|Set A: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270721|NCT02716987|BG004|Baseline|Set B: [18F]PGM299|[18F]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
11270722|NCT02716987|BG005|Baseline|Set A: [18F]PGM299 Baseline|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
11270723|NCT02716987|BG006|Baseline|Total|Total of all reporting groups
11270724|NCT02716987|FG000|Participant Flow|Set A: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of Positron Emission Tomography (PET) ligand PGM028299 labeled with [18F] ([18F]PGM299) with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270725|NCT02716987|FG001|Participant Flow|Set A: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270726|NCT02716987|FG002|Participant Flow|Set A: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270727|NCT02716987|FG003|Participant Flow|Set A: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270728|NCT02716987|FG004|Participant Flow|Set B: [18F]PGM299|[18F]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
11270729|NCT02716987|FG005|Participant Flow|Set A: [18F]PGM299 Baseline|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
11270730|NCT02716987|OG000|Outcome|Set A: TAK-831 100 mg|TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270731|NCT02716987|OG001|Outcome|Set A: TAK-831 200 mg|TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270732|NCT02716987|OG002|Outcome|Set A: TAK-831 250 mg|TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270733|NCT02716987|OG003|Outcome|Set A: TAK-831 500 mg|TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270734|NCT02716987|OG004|Outcome|Set B: [18F]PGM299|[18F]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
11270735|NCT02716987|OG005|Outcome|Set A: [18F]PGM299 Baseline|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
11270736|NCT02716987|OG004|Outcome|Set A: [18F]PGM299 Baseline|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
11270737|NCT02716987|OG000|Outcome|Set A: All Participants|Participants received TAK-831 100, 200, 250 or 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
11270738|NCT02716987|OG000|Outcome|Set B: [18F]PGM299|[18F]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
11270739|NCT02716987|EG000|Reported Event|Set A: [18F]PGM299 Dose 1 to Prior TAK-831 100 mg Dose|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 100 mg, suspension, orally, once on Day 1.
11270740|NCT02716987|EG001|Reported Event|Set A: [18F]PGM299 Dose 1 to Prior TAK-831 200 mg Dose|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 200 mg, suspension, orally, once on Day 1.
11270741|NCT02716987|EG002|Reported Event|Set A: [18F]PGM299 Dose 1 to Prior TAK-831 250 mg Dose|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 250 mg, suspension, orally, once on Day 1.
11270742|NCT02716987|EG003|Reported Event|Set A: [18F]PGM299 Dose 1 to Prior TAK-831 500 mg Dose|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 500 mg, suspension, orally, once on Day 1.
11270743|NCT02716987|EG004|Reported Event|Set A: TAK-831 100 mg Dose to Prior [18F]PGM299 Dose 2|TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at [18F]PGM299 Dose 2 (2 hours post-TAK-831 dose).
11270744|NCT02716987|EG005|Reported Event|Set A: TAK-831 200 mg Dose to Prior [18F]PGM299 Dose 2|TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F]PGM299 Dose 2 (2 hours post-TAK-831 dose).
11270745|NCT02716987|EG006|Reported Event|Set A: TAK-831 250 mg Dose to Prior [18F]PGM299 Dose 2|TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F]PGM299 Dose 2 (2 hours post-TAK-831 dose).
11270746|NCT02716987|EG007|Reported Event|Set A: TAK-831 500 mg Dose to Prior [18F]PGM299 Dose 2|TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of [18F]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F]PGM299 Dose 2 (2 hours post-TAK-831 dose).
11270747|NCT02716987|EG008|Reported Event|SetA:TAK-831 100mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 100 mg dose up to follow up on Day 15.
11270748|NCT02716987|EG009|Reported Event|SetA:TAK-831 200mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 200 mg dose up to follow up on Day 15.
11270749|NCT02716987|EG010|Reported Event|SetA:TAK-831 250mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 250 mg dose up to follow up on Day 15.
11270750|NCT02716987|EG011|Reported Event|SetA:TAK-831 500mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 500 mg dose up to follow up on Day 15.
11270751|NCT02716987|EG012|Reported Event|Set B: [18F]PGM299|[18F]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
11270752|NCT02716987|EG013|Reported Event|Set A: [18F]PGM299 Baseline|[18F]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
11270753|NCT02717195|BG000|Baseline|Non-randomized Patients|Patients not randomized into the double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm independent of treatment.
11270754|NCT02717195|BG001|Baseline|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
11270755|NCT02717195|BG002|Baseline|DBT Period, Lu AF35700 20 mg|Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
11270756|NCT02717195|BG003|Baseline|DBT Period, Continued Treatment From PC Period|Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
11270757|NCT02717195|BG004|Baseline|Total|Total of all reporting groups
11270758|NCT02717195|FG000|Participant Flow|Prospective Confirmation (PC) Period, Risperidone|"Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks~Risperidone: 4-6 mg/day, encapsulated tablets, orally"
11270759|NCT02717195|FG001|Participant Flow|PC Period, Olanzapine|"Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks~Olanzapine: 15-20 mg/day, encapsulated tablets, orally"
11270760|NCT02717195|FG002|Participant Flow|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
11270761|NCT02717195|FG003|Participant Flow|DBT Period, Lu AF35700 20 mg|Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
11270762|NCT02717195|FG004|Participant Flow|DBT Period, Continued Treatment From PC Period|Patients in this arm will continue the treatment allocated in the PC Period at the dose set at last visit of the PC Period. The analysis is made independent on which treatment the patient was on (risperidone or olanzapine)
11270763|NCT02717195|OG000|Outcome|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
11270764|NCT02717195|OG001|Outcome|DBT Period, Lu AF35700 20 mg|Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
11270765|NCT02717195|OG002|Outcome|DBT Period, Continued Treatment From PC Period|Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
11270766|NCT02717195|OG000|Outcome|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|"Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks~Lu AF35700: 10 mg/day, encapsulated tablets, orally"
11270767|NCT02717195|OG001|Outcome|DBT Period, Lu AF35700 20 mg|"Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks~Lu AF35700: 20 mg/day, encapsulated tablets, orally"
11270768|NCT02717195|OG002|Outcome|DBT Period, Continued Treatment From PC Period|"Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period~Risperidone: 4-6 mg/day, encapsulated tablets, orally~Olanzapine: 15-20 mg/day, encapsulated tablets, orally"
11270769|NCT02717195|EG000|Reported Event|Prospective Confirmation (PC) Period, Risperidone|Patients not randomized to double-blind treatment
11270770|NCT02717195|EG001|Reported Event|PC Period, Olanzapine|Patients not randomized to double-blind treatment
11270771|NCT02717195|EG002|Reported Event|Double Blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
11270772|NCT02717195|EG003|Reported Event|DBT Period, Lu AF35700 20 mg|Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
11092293|NCT01538862|OG000|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
11092294|NCT01538862|EG000|Reported Event|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
11270773|NCT02717195|EG004|Reported Event|DBT Period, Continued Treatment From PC Period|Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone).
11270774|NCT02717273|BG000|Baseline|Standard Peri-operative Antibiotic Regimen|"The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.~standard: peri-operative antibiotic regimen only~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270775|NCT02717273|BG001|Baseline|Extended Three-day Course of Antibiotics|"For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.~This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.~extended: extended three-day course of antibiotics~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270776|NCT02717273|BG002|Baseline|Total|Total of all reporting groups
11270777|NCT02717273|FG000|Participant Flow|Standard Peri-operative Antibiotic Regimen|"The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.~standard: peri-operative antibiotic regimen only~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270778|NCT02717273|FG001|Participant Flow|Extended Three-day Course of Antibiotics|"For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.~This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.~extended: extended three-day course of antibiotics~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270779|NCT02717273|OG000|Outcome|Standard Peri-operative Antibiotic Regimen|"The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.~standard: peri-operative antibiotic regimen only~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270780|NCT02717273|OG001|Outcome|Extended Three-day Course of Antibiotics|"For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.~This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.~extended: extended three-day course of antibiotics~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270781|NCT02717273|EG000|Reported Event|Standard Peri-operative Antibiotic Regimen|"The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.~standard: peri-operative antibiotic regimen only~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270782|NCT02717273|EG001|Reported Event|Extended Three-day Course of Antibiotics|"For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.~This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.~extended: extended three-day course of antibiotics~steroids: 500mg methylprednisolone intravenously~liver transplant: orthotopic liver transplantation"
11270783|NCT02717494|BG000|Baseline|Arm 1A (PPV-23)|"In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270784|NCT02717494|BG001|Baseline|Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270785|NCT02717494|BG002|Baseline|Arm 1C (Placebo)|"In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270786|NCT02717494|BG003|Baseline|Total|Total of all reporting groups
11270787|NCT02717494|FG000|Participant Flow|Arm 1A (PPV-23)|"In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270788|NCT02717494|FG001|Participant Flow|Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270789|NCT02717494|FG002|Participant Flow|Arm 1C (Placebo)|"In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270790|NCT02717494|OG000|Outcome|Arm 1A (PPV-23)|"In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270791|NCT02717494|OG001|Outcome|Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270792|NCT02717494|OG002|Outcome|Arm 1C (Placebo)|"In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270793|NCT02717494|OG000|Outcome|Arm 2A (PPV-23)|"In Step 2, women who received Placebo in Step 1 and who were randomized to Arm 2A were administered a 0.5 mL dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270794|NCT02717494|OG001|Outcome|Arm 2B (PCV-10)|"In Step 2, women who received Placebo in Step 1 and who were randomized to Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270795|NCT02717494|OG000|Outcome|Infants Born to Women in Arm 1A (PPV-23)|"In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270796|NCT02717494|OG001|Outcome|Infants Born to Women in Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270797|NCT02717494|OG002|Outcome|Infants Born to Women in Arm 1C (Placebo)|"In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270798|NCT02717494|OG000|Outcome|Arm 1A (PPV-23)|"These are the infants born to the pregnant women in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270799|NCT02717494|OG001|Outcome|Arm 1B (PCV-10)|"These are the infants born to the pregnant women in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270800|NCT02717494|OG002|Outcome|Arm 1C (Placebo)|"These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270801|NCT02717494|OG001|Outcome|Arm 2A (PPV-23)|"In Step 2, women who received placebo in step 1 that were randomized to Arm 2A were administered a 0.5 mL dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270802|NCT02717494|OG000|Outcome|Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270803|NCT02717494|OG000|Outcome|Infants of Mothers in Arm 1A (PPV-23)|"These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270804|NCT02717494|OG001|Outcome|Infants of Mothers in Arm 1B (PCV-10)|"These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270805|NCT02717494|OG002|Outcome|Infants of Mothers in Arm 1C (Placebo)|"These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270806|NCT02717494|EG000|Reported Event|Arm 1A (PPV-23)|"In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270807|NCT02717494|EG001|Reported Event|Arm 1B (PCV-10)|"In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270808|NCT02717494|EG002|Reported Event|Arm 1C (Placebo)|"In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270809|NCT02717494|EG003|Reported Event|Arm 2A (PPV-23)|"In Step 2, women in Arm 2A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270810|NCT02717494|EG004|Reported Event|Arm 2B (PCV-10)|"In Step 2, women in Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270811|NCT02717494|EG005|Reported Event|Infants of Mothers in Arm 1A (PPV-23)|"These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once.~PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes."
11270812|NCT02717494|EG006|Reported Event|Infants of Mothers in Arm 1B (PCV-10)|"These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once.~PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes."
11270813|NCT02717494|EG007|Reported Event|Infants of Mothers in Arm 1C (Placebo)|"These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once.~NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy."
11270814|NCT02717546|BG000|Baseline|Group One|"Distal Tibia Fracture repaired with Zimmer MotionLoc Screw~Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating."
11270815|NCT02717546|FG000|Participant Flow|Group One|"Distal Tibia Fracture repaired with Zimmer MotionLoc Screw~Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating."
11270816|NCT02717546|OG000|Outcome|Group One|"Distal Tibia Fracture repaired with Zimmer MotionLoc Screw~Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating."
11270817|NCT02717546|EG000|Reported Event|Group One|"Distal Tibia Fracture repaired with Zimmer MotionLoc Screw~Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating."
11270818|NCT02717754|BG000|Baseline|Placebo|Participants received oseltamivir matched placebo BID for 5 days.
11270819|NCT02717754|BG001|Baseline|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
11270820|NCT02717754|BG002|Baseline|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
11270821|NCT02717754|BG003|Baseline|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
11270822|NCT02717754|BG004|Baseline|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
11270823|NCT02717754|BG005|Baseline|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
11270824|NCT02717754|BG006|Baseline|Total|Total of all reporting groups
11270825|NCT02717754|FG000|Participant Flow|Placebo|Participants received oseltamivir matched placebo twice daily (BID) for 5 days.
11270826|NCT02717754|FG001|Participant Flow|Oseltamivir 100 mg|Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.
11270827|NCT02717754|FG002|Participant Flow|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
11270828|NCT02717754|FG003|Participant Flow|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
11270829|NCT02717754|FG004|Participant Flow|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
11270830|NCT02717754|FG005|Participant Flow|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
11270831|NCT02717754|OG000|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
11270832|NCT02717754|OG001|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
11270833|NCT02717754|EG000|Reported Event|Placebo|Participants received oseltamivir matched placebo for 5 days.
11270834|NCT02717754|EG001|Reported Event|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
11270835|NCT02717754|EG002|Reported Event|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
11270836|NCT02717754|EG003|Reported Event|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
11270837|NCT02717754|EG004|Reported Event|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
11270838|NCT02717754|EG005|Reported Event|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
11270839|NCT02718040|BG000|Baseline|Emervel Treatment Group|"Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep~Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity treated by product type:~Emervel Classic:~Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3~Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4~Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)"
11270840|NCT02718040|FG000|Participant Flow|Emervel Treatment Group|"Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep~Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity treated by product type:~Emervel Classic:~Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3~Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4~Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)"
11270841|NCT02718040|OG000|Outcome|Emervel Treatment Group|"Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep~Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity treated by product type:~Emervel Classic:~Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3~Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4~Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)"
11270842|NCT02718040|EG000|Reported Event|Emervel Treatment Group|"Eligible subjects receive bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep~Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity to be treated by product type:~Emervel Classic:~Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3~Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4~Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)"
11270843|NCT02718118|BG000|Baseline|1.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270844|NCT02718118|BG001|Baseline|2.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270845|NCT02718118|BG002|Baseline|Total|Total of all reporting groups
11270846|NCT02718118|FG000|Participant Flow|1.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270847|NCT02718118|FG001|Participant Flow|2.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270848|NCT02718118|OG000|Outcome|1.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270849|NCT02718118|OG001|Outcome|2.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270850|NCT02718118|EG000|Reported Event|1.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270851|NCT02718118|EG001|Reported Event|2.5 mL Reconstitution|"Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit.~Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown."
11270852|NCT02718131|BG000|Baseline|INFUSE Bone Graft (BMP-2)|"Children with NF1 and tibial pseudarthrosis who require surgery will have the INFUSE bone graft added to their surgical protocol. After a standard surgical approach of resection of abnormal pseudarthrotic tissue, placement of a rigid intramedullary rod (of the surgeon's choice) and placement of autogenous bone graft from the iliac crest; in addition, the INFUSE bone graft in the form of a collagen sponge will be wrapped around the tibia during the surgical process.~INFUSE Bone Graft (BMP-2): The INFUSE bone graft, containing BMP-2 on a collagen sponge, will be wrapped around the tibia during the surgical process."
11270853|NCT02718131|BG001|Baseline|Control Group|"Children with NF1 and tibial pseudarthrosis who require surgery will receive the standard surgical protocol only. This includes resection of abnormal pseudarthrotic tissue, placement of a rigid intramedullary rod (of the surgeon's choice) and placement of autogenous bone graft from the iliac crest.~Control Group: The control group will receive the standard surgical protocol, without addition of the INFUSE device."
11270854|NCT02718131|BG002|Baseline|Total|Total of all reporting groups
11270855|NCT02718131|FG000|Participant Flow|INFUSE Bone Graft (BMP-2)|Standard surgery plus BMP-2
11270856|NCT02718131|FG001|Participant Flow|Control Group|Standard surgery without BMP-2
11270857|NCT02718131|OG000|Outcome|INFUSE Bone Graft (BMP-2)|Standard surgery plus BMP-2
11270858|NCT02718131|OG001|Outcome|Control Group|Standard surgery without BMP-2
11270859|NCT02718131|OG000|Outcome|INFUSE Bone Graft (BMP-2)|"Children with NF1 and tibial pseudarthrosis who require surgery will have the INFUSE bone graft added to their surgical protocol. After a standard surgical approach of resection of abnormal pseudarthrotic tissue, placement of a rigid intramedullary rod (of the surgeon's choice) and placement of autogenous bone graft from the iliac crest; in addition, the INFUSE bone graft in the form of a collagen sponge will be wrapped around the tibia during the surgical process.~INFUSE Bone Graft (BMP-2): The INFUSE bone graft, containing BMP-2 on a collagen sponge, will be wrapped around the tibia during the surgical process."
11270860|NCT02718131|OG001|Outcome|Control Group|"Children with NF1 and tibial pseudarthrosis who require surgery will receive the standard surgical protocol only. This includes resection of abnormal pseudarthrotic tissue, placement of a rigid intramedullary rod (of the surgeon's choice) and placement of autogenous bone graft from the iliac crest.~Control Group: The control group will receive the standard surgical protocol, without addition of the INFUSE device."
11270861|NCT02718131|EG000|Reported Event|INFUSE Bone Graft (BMP-2)|Standard surgery plus BMP-2
11270862|NCT02718131|EG001|Reported Event|Control Group|Standard surgery without BMP-2
11270863|NCT02718157|BG000|Baseline|Accuracy Testing|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain."
11270864|NCT02718157|FG000|Participant Flow|Accuracy Testing|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain."
11270865|NCT02718157|OG000|Outcome|Accuracy Testing|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain."
11270866|NCT02718157|EG000|Reported Event|Accuracy Testing|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain."
11270867|NCT02718248|BG000|Baseline|CHESS Mobile Health Group|"The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus.~CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.~Problem solving therapy: Face to face problem solving therapy every week for six weeks."
11270868|NCT02718248|FG000|Participant Flow|CHESS Mobile Health Group|"The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus.~CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.~Problem solving therapy: Face to face problem solving therapy every week for six weeks."
11337604|NCT03588910|OG001|Outcome|Half the Number of Oxycodone Tablets Typically Prescribed|"Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11270869|NCT02718248|OG000|Outcome|CHESS Mobile Health Group|"The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus.~CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.~Problem solving therapy: Face to face problem solving therapy every week for six weeks."
11270870|NCT02718248|EG000|Reported Event|CHESS Mobile Health Group|"The intervention will be six weekly one hour sessions of face-to-face problem solving therapy combined with the CHESS Mobile Health smart phone application (Comprehensive Health Enhancement Support System - CHESS). The CHESS Mobile Health smart phone application enables users to access relevant resources, create a support network and check in regularly with carers. The intervention will be delivered by Dr. Hatcher, a staff psychiatrist in Liaison Psychiatry at The Ottawa Hospital General Campus.~CHESS Mobile Health smart phone application: A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.~Problem solving therapy: Face to face problem solving therapy every week for six weeks."
11270871|NCT02718326|BG000|Baseline|Sham Treatment|All participants received sham injections in the study eye every 4 weeks (Q4) to week 16 (after 5 initial monthly sham injections), followed by sham injections Q8 to week 96.
11270872|NCT02718326|BG001|Baseline|Intravitreal Aflibercept Injection (IAI) 2Q16|All participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96.
11270873|NCT02718326|BG002|Baseline|Intravitreal Aflibercept Injection (IAI) 2Q8|All participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270874|NCT02718326|BG003|Baseline|Total|Total of all reporting groups
11270875|NCT02718326|FG000|Participant Flow|Sham Treatment|All participants received sham injections in the study eye every 4 weeks (Q4) to week 16 (after 5 initial monthly sham injections), followed by sham injections Q8 to week 96.
11270876|NCT02718326|FG001|Participant Flow|Intravitreal Aflibercept Injection (IAI) 2Q16|All participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96.
11270877|NCT02718326|FG002|Participant Flow|Intravitreal Aflibercept Injection (IAI) 2Q8|All participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270878|NCT02718326|OG000|Outcome|Sham Treatment|All participants received sham injections in the study eye every 4 weeks (Q4) to week 16 (after 5 initial monthly sham injections), followed by sham injections Q8 to week 96.
11270879|NCT02718326|OG001|Outcome|Intravitreal Aflibercept Injection (IAI) 2Q16|All participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96.
11270880|NCT02718326|OG002|Outcome|Intravitreal Aflibercept Injection (IAI) 2Q8|All participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270881|NCT02718326|OG003|Outcome|IAI 2 mg Groups Combined (2Q16 & 2Q8)|IAI 2Q16: Participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96; IAI 2Q8: Participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270882|NCT02718326|EG000|Reported Event|Sham Treatment|All participants received sham injections in the study eye every 4 weeks (Q4) to week 16 (after 5 initial monthly sham injections), followed by sham injections Q8 to week 96.
11270883|NCT02718326|EG001|Reported Event|Intravitreal Aflibercept Injection (IAI) 2Q16|All participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96.
11270884|NCT02718326|EG002|Reported Event|Intravitreal Aflibercept Injection (IAI) 2Q8|All participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270885|NCT02718326|EG003|Reported Event|IAI 2 mg Groups Combined (2Q16 & 2Q8)|IAI 2Q16: Participants received a 2 milligram (mg) Intravitreal Aflibercept Injection (IAI) in the study eye every 16 weeks (2Q16) (after 3 initial monthly doses and one 8-week interval) to week 96; IAI 2Q8: Participants received 2 mg IAI in the study eye every 8 weeks (2Q8) from day 1 up to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with IAI 2 mg to week 96.
11270886|NCT02718417|BG000|Baseline|Chemotherapy Followed by Avelumab|In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
10847348|NCT00282841|BG000|Baseline|All Stroke Code Patients|Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
11270887|NCT02718417|BG001|Baseline|Chemotherapy + Avelumab Followed by Avelumab|In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270888|NCT02718417|BG002|Baseline|Chemotherapy Followed by Observation|In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
11270889|NCT02718417|BG003|Baseline|Total|Total of all reporting groups
11270890|NCT02718417|FG000|Participant Flow|Chemotherapy Followed by Avelumab|In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270891|NCT02718417|FG001|Participant Flow|Chemotherapy + Avelumab Followed by Avelumab|In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
10970172|NCT00909220|BG000|Baseline|Current Major Depressive Disorder|"participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).~Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).~Behavioral Activation: 16 weekly study visits aimed at identifying avoidance patterns used in social or physical situations that contribute to depression and replacing them with reinforcing experiences using directive behavioral strategies."
10970173|NCT00909220|BG001|Baseline|Healthy Participants|participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks. Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).).
10970174|NCT00909220|BG002|Baseline|Total|Total of all reporting groups
10970175|NCT00909220|FG000|Participant Flow|Current Major Depressive Disorder|"Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986) were enrolled into a treatment study at Northwestern University's Feinberg School of Medicine in Chicago, Illinois.~Behavioral Activation: 16 weekly study visits aimed at identifying avoidance patterns used in social or physical situations that contribute to depression and replacing them with reinforcing experiences using directive behavioral strategies"
10970176|NCT00909220|FG001|Participant Flow|Healthy Participants|Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks
10970177|NCT00909220|OG000|Outcome|Current Major Depressive Disorder|Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA. DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).
10970178|NCT00909220|OG001|Outcome|Healthy Participants|An additional 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled
11270892|NCT02718417|FG002|Participant Flow|Chemotherapy Followed by Observation|In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
11270893|NCT02718417|OG000|Outcome|Chemotherapy Followed by Avelumab|In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270894|NCT02718417|OG001|Outcome|Chemotherapy + Avelumab Followed by Avelumab|In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270895|NCT02718417|OG002|Outcome|Chemotherapy Followed by Observation|In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
11270896|NCT02718417|OG000|Outcome|PK: Chemotherapy Followed by Avelumab|In chemotherapy phase, participants received paclitaxel once every three weeks (Q3W) (or once weekly [QW] on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab once every 2 weeks (Q2W) on Days 1, 15 and 29 of each 42 day cycle.
11270897|NCT02718417|OG001|Outcome|PK: Chemotherapy + Avelumab Followed by Avelumab|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
11270898|NCT02718417|OG002|Outcome|PK: Chemotherapy Followed by Observation|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
11270899|NCT02718417|OG000|Outcome|PK: Chemotherapy Followed by Avelumab|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
11270900|NCT02718417|OG000|Outcome|PK: Chemotherapy + Avelumab Followed by Avelumab|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
11270901|NCT02718417|OG000|Outcome|Immunogenicity: Chemotherapy Followed by Avelumab|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
11270902|NCT02718417|OG001|Outcome|Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab|In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
11270903|NCT02718417|EG000|Reported Event|Chemotherapy Followed by Avelumab|In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270904|NCT02718417|EG001|Reported Event|Chemotherapy + Avelumab Followed by Avelumab|In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
11270905|NCT02718417|EG002|Reported Event|Chemotherapy Followed by Observation|In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
11270906|NCT02718625|BG000|Baseline|Santyl|"Santyl collagenase ointment applied topically once per day for up to six weeks~Santyl: Collagenase ointment applied topically"
11270907|NCT02718625|BG001|Baseline|SoloSite®|"SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.~SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound."
11270908|NCT02718625|BG002|Baseline|Total|Total of all reporting groups
11270909|NCT02718625|FG000|Participant Flow|Santyl|"Santyl collagenase ointment applied topically once per day for up to six weeks~Santyl: Collagenase ointment applied topically"
11270910|NCT02718625|FG001|Participant Flow|SoloSite®|"SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.~SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound."
11270911|NCT02718625|OG000|Outcome|Santyl|"Santyl collagenase ointment applied topically once per day for up to six weeks~Santyl: Collagenase ointment applied topically"
11270912|NCT02718625|OG001|Outcome|SoloSite®|"SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.~SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound."
11270913|NCT02718625|EG000|Reported Event|Santyl|"Santyl collagenase ointment applied topically once per day for up to six weeks~Santyl: Collagenase ointment applied topically"
11270914|NCT02718625|EG001|Reported Event|SoloSite®|"SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.~SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound."
11270915|NCT02718898|BG000|Baseline|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
11270916|NCT02718898|BG001|Baseline|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
11270917|NCT02718898|BG002|Baseline|Total|Total of all reporting groups
11270918|NCT02718898|FG000|Participant Flow|Placebo - Blinded Treatment|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by Subcutaneous injection during blinded treatment period.
11270919|NCT02718898|FG001|Participant Flow|Ixekizumab 80mg Q2W - Blinded Treatment|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.
11270920|NCT02718898|FG002|Participant Flow|Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period|"Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.~Participants had an option to step-up to Q2W dosing starting at week 24 through week 40."
11270921|NCT02718898|FG003|Participant Flow|Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment|"Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.~Participants had an option to step-up to Q2W dosing starting at week 24 through week 40."
11270922|NCT02718898|FG004|Participant Flow|Placebo - Post Treatment Follow-up|Participants did not receive any study treatment during post treatment follow-up period.
11270923|NCT02718898|FG005|Participant Flow|Ixeqizumab 80mg Q4W - Post Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period.
11270924|NCT02718898|FG006|Participant Flow|Ixekizumab 80mg Q2W - Post Treatment Follow-up|Participants did not receive any study treatment during post treatment follow-up period.
11270925|NCT02718898|OG000|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by subcutaneous injection.
11270926|NCT02718898|OG001|Outcome|Ixekizumab 80mg Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
11270927|NCT02718898|OG000|Outcome|Placebo|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
11270928|NCT02718898|OG001|Outcome|Ixekizumab Q2W|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
11270929|NCT02718898|EG000|Reported Event|Placebo - Blinded Treatment Period|Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by subcutaneous injection during blinded treatment period.
11270930|NCT02718898|EG001|Reported Event|Ixekizumab 80 mg Q2W - Blinded Treatment Period|Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
11270931|NCT02718898|EG002|Reported Event|Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period|"Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.~Participants had an option to step-up to Q2W dosing starting at week 24 through week 40."
11270932|NCT02718898|EG003|Reported Event|Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment|"Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.~Participants had an option to step-up to Q2W dosing starting at week 24 through week 40."
11270933|NCT02718898|EG004|Reported Event|Placebo - Post Treatment Follow-up|Participants did not receive any study treatment during post treatment follow-up period.
11270934|NCT02718898|EG005|Reported Event|Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period|Participants did not receive any study treatment during post treatment follow-up period.
11270935|NCT02718898|EG006|Reported Event|Ixekizumab 80mg Q4W - Post Treatment Follow-up|Participants did not receive any study treatment during post treatment follow-up period.
11270936|NCT02718963|BG000|Baseline|Control Group|"control group(N=10): who does not have dysphagia symptom~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270937|NCT02718963|BG001|Baseline|Experimental Group|"experimental group(N=10): who have dysphagia symptoms~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270938|NCT02718963|BG002|Baseline|Total|Total of all reporting groups
11270939|NCT02718963|FG000|Participant Flow|Control Group|"control group(N=10): who does not have dysphagia symptom~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270940|NCT02718963|FG001|Participant Flow|Experimental Group|"experimental group(N=10): who have dysphagia symptoms~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270941|NCT02718963|OG000|Outcome|Control Group|"control group(N=10): who does not have dysphagia symptom~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270942|NCT02718963|OG001|Outcome|Experimental Group|"experimental group(N=10): who have dysphagia symptoms~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270943|NCT02718963|EG000|Reported Event|Control Group|"control group(N=10): who does not have dysphagia symptom~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
11270944|NCT02718963|EG001|Reported Event|Experimental Group|"experimental group(N=10): who have dysphagia symptoms~apply Synchronized Electrical Stimulation Device~before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function~Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition"
10970179|NCT00909220|OG000|Outcome|Current Major Depressive Disorder|participants diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID; First, Spitzer, Gibbon, & Williams, 2002) and a score > 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C; Rush et al., 2003; Rush et al., 1986).
10970180|NCT00909220|OG001|Outcome|Healthy Participants|Healthy participants were enrolled with no lifetime history or current presentation of psychiatric symptoms per the SCID and a score < 11 on the IDS-C.
10970181|NCT00909220|EG000|Reported Event|Current Major Depressive Disorder|Diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID) and a score ≥ 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C).
10970182|NCT00909220|EG001|Reported Event|Healthy Participants|No lifetime history or current presentation of psychiatric symptoms per the SCID and a score ≤ 11 on the IDS-C.
10970183|NCT00909324|BG000|Baseline|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
10970184|NCT00909324|BG001|Baseline|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
10970185|NCT00909324|BG002|Baseline|Total|Total of all reporting groups
11270945|NCT02719028|BG000|Baseline|Placebo|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day.~placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)"
11270946|NCT02719028|BG001|Baseline|Antroquinonol 50 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270947|NCT02719028|BG002|Baseline|Antroquinonol 100 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
10970186|NCT00909324|FG000|Participant Flow|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
10970187|NCT00909324|FG001|Participant Flow|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
10970188|NCT00909324|OG000|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
10970189|NCT00909324|OG001|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
10970190|NCT00909324|EG000|Reported Event|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
10970191|NCT00909324|EG001|Reported Event|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
10970192|NCT00909363|BG000|Baseline|Promacta|"Promacta® is commercially available in 12.5 mg, 25 mg, 50 mg, and 75 mg tablets. For this study, for young children unable to swallow a tablet, eltrombopag powder for oral suspension (Eltrombopag PfOS) will be used. PfOS is only available for investigational use at 20mg. Each sachet contains eltrombopag equivalent to 20mg per gm of powder and is reconstituted to a total of 10 ml so that the concentration is 2 mg/ml.~Promacta (eltrombopag): Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP.~Eltrombopag/promacta: Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP."
10970193|NCT00909363|BG001|Baseline|Healthy Volunteers|5 well children having blood drawn for another reason: 3 pre-op and 2 for HLAA-typing
10970194|NCT00909363|BG002|Baseline|WAS Patients for Blood Drawing Only|patients with WAS either not eligible or not interested in eltrombpopag treatment who are willing to have their blood drawn once
10970195|NCT00909363|BG003|Baseline|Total|Total of all reporting groups
10970196|NCT00909363|FG000|Participant Flow|WAS Patients Treated With Promacta|"Promacta® is commercially available in 12.5 mg, 25 mg, 50 mg, and 75 mg tablets. For this study, for young children unable to swallow a tablet, eltrombopag powder for oral suspension (Eltrombopag PfOS) will be used. PfOS is only available for investigational use at 20mg. Each sachet contains eltrombopag equivalent to 20mg per gm of powder and is reconstituted to a total of 10 ml so that the concentration is 2 mg/ml.~Promacta (eltrombopag): WAS Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP.~Eltrombopag/promacta: Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP."
11270948|NCT02719028|BG003|Baseline|Antroquinonol 150 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270949|NCT02719028|BG004|Baseline|Total|Total of all reporting groups
11270950|NCT02719028|FG000|Participant Flow|Placebo|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day.~placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)"
11270951|NCT02719028|FG001|Participant Flow|Antroquinonol 50 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270952|NCT02719028|FG002|Participant Flow|Antroquinonol 100 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270953|NCT02719028|FG003|Participant Flow|Antroquinonol 150 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270954|NCT02719028|OG000|Outcome|Placebo|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day.~placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)"
11270955|NCT02719028|OG001|Outcome|Antroquinonol 50 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270956|NCT02719028|OG002|Outcome|Antroquinonol 100 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270957|NCT02719028|OG003|Outcome|Antroquinonol 150 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270958|NCT02719028|EG000|Reported Event|Placebo|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day.~placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)"
11270959|NCT02719028|EG001|Reported Event|Antroquinonol 50 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270960|NCT02719028|EG002|Reported Event|Antroquinonol 100 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270961|NCT02719028|EG003|Reported Event|Antroquinonol 150 mg PO|"Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day.~Antroquinonol: Antroquinonol will be provided as capsules of 50 mg"
11270962|NCT02719158|BG000|Baseline|6 mg OTO-201|6 mg ciprofloxacin: single administration of OTO-201
11270963|NCT02719158|BG001|Baseline|12 mg OTO-201|12 mg ciprofloxacin: single administration of OTO-201
11270964|NCT02719158|BG002|Baseline|Control|Sham Control: simulated, single administration
11270965|NCT02719158|BG003|Baseline|Total|Total of all reporting groups
11270966|NCT02719158|FG000|Participant Flow|6 mg OTO-201|6 mg ciprofloxacin: single administration of OTO-201
11270967|NCT02719158|FG001|Participant Flow|12 mg OTO-201|12 mg ciprofloxacin: single administration of OTO-201
11270968|NCT02719158|FG002|Participant Flow|Control|Sham Control: simulated, single administration
11270969|NCT02719158|OG000|Outcome|6 mg OTO-201|6 mg ciprofloxacin: single administration of OTO-201
11270970|NCT02719158|OG001|Outcome|12 mg OTO-201|12 mg ciprofloxacin: single administration of OTO-201
11270971|NCT02719158|OG002|Outcome|Control|Sham Control: simulated, single administration
11270972|NCT02719158|EG000|Reported Event|6 mg OTO-201|6 mg ciprofloxacin: single administration of OTO-201
11270973|NCT02719158|EG001|Reported Event|12 mg OTO-201|12 mg ciprofloxacin: single administration of OTO-201
11270974|NCT02719158|EG002|Reported Event|Control|Sham Control: simulated, single administration
11270975|NCT02719171|BG000|Baseline|Placebo|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270976|NCT02719171|BG001|Baseline|Risankizumab 150 mg Every 4 Weeks|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270977|NCT02719171|BG002|Baseline|Risankizumab 150 mg Weeks 0, 4, and 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
11270978|NCT02719171|BG003|Baseline|Risankizumab 150 mg Weeks 0 and 12|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
11270979|NCT02719171|BG004|Baseline|Risankizumab 75 mg Week 0|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
11270980|NCT02719171|BG005|Baseline|Total|Total of all reporting groups
11270981|NCT02719171|FG000|Participant Flow|Placebo|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270982|NCT02719171|FG001|Participant Flow|Risankizumab 150 mg Every 4 Weeks|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270983|NCT02719171|FG002|Participant Flow|Risankizumab 150 mg Weeks 0, 4, and 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
11270984|NCT02719171|FG003|Participant Flow|Risankizumab 150 mg Weeks 0 and 12|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
11270985|NCT02719171|FG004|Participant Flow|Risankizumab 75 mg Week 0|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
11270986|NCT02719171|OG000|Outcome|Placebo|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270987|NCT02719171|OG001|Outcome|Risankizumab 150 mg Every 4 Weeks|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270988|NCT02719171|OG002|Outcome|Risankizumab 150 mg Weeks 0, 4, and 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
11270989|NCT02719171|OG003|Outcome|Risankizumab 150 mg Weeks 0 and 12|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
11270990|NCT02719171|OG004|Outcome|Risankizumab 75 mg Week 0|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
11270991|NCT02719171|OG005|Outcome|Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
11270992|NCT02719171|OG006|Outcome|Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
11270993|NCT02719171|OG005|Outcome|Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
11270994|NCT02719171|EG000|Reported Event|Placebo|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270995|NCT02719171|EG001|Reported Event|Risankizumab 150 mg Every 4 Weeks|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
11270996|NCT02719171|EG002|Reported Event|Risankizumab 150 mg Weeks 0, 4, and 16|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
11270997|NCT02719171|EG003|Reported Event|Risankizumab 150 mg Weeks 0 and 12|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
11270998|NCT02719171|EG004|Reported Event|Risankizumab 75 mg Week 0|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
11270999|NCT02719353|BG000|Baseline|Overall Study|"Subjects will be randomized to wear the test contact lenses or control contact lenses first as per the randomization table bilaterally for four days then cross-over to alternated pair lenses.~comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses"
11271000|NCT02719353|FG000|Participant Flow|Test Lens Then Control Lens|"Subjects will be randomized to wear the test contact lenses then control contact lenses bilaterally for four days in the cross-over study.~comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses"
11271001|NCT02719353|FG001|Participant Flow|Control Lens Then Test Lens|"Subjects will be randomized to wear the control contact lenses then test contact lenses bilaterally for four days in the cross-over study.~comfilcon A control lens: contact lenses comfilcon A Extended Range test lens: contact lenses"
11271002|NCT02719353|OG000|Outcome|Comfilcon A Extended Range Test Lens|"Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.~comfilcon A Extended Range test lens: contact lens"
11271003|NCT02719353|OG001|Outcome|Comfilcon A Control Lens|"Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.~comfilcon A control lens: contact lens"
11271004|NCT02719353|OG000|Outcome|Overall Study|Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study.
11271005|NCT02719353|EG000|Reported Event|Comfilcon A Extended Range Test Lens|"Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.~comfilcon A Extended Range test lens: contact lens"
11271006|NCT02719353|EG001|Reported Event|Comfilcon A Control Lens|"Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.~comfilcon A control lens: contact lens"
11271007|NCT02719366|BG000|Baseline|Overall Study|"Subjects will be randomized to wear the test contact lenses or control contact lenses bilaterally first for four days then cross-over to alternate study lenses.~comfilcon A Extended Range test lens: contact lenses~comfilcon A control lens: contact lenses"
11271008|NCT02719366|FG000|Participant Flow|Test Lens Then Control Lens|"Subjects will be randomized to wear the test contact lenses first then control contact lenses bilaterally for four days in the cross-over study.~comfilcon A Extended Range test lens: contact lenses~comfilcon A control lens: contact lenses"
11271009|NCT02719366|FG001|Participant Flow|Control Lens Then Test Lens|"Subjects will be randomized to wear the control contact lenses first then test contact lenses bilaterally for four days in the cross-over study.~comfilcon A control lens: contact lenses~comfilcon A Extended Range test lens: contact lenses"
11271010|NCT02719366|OG000|Outcome|Comfilcon A Extended Range Test Lens|"Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.~comfilcon A Extended Range test lens: contact lenses"
11271011|NCT02719366|OG001|Outcome|Comfilcon A Control Lens|"Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.~comfilcon A control lens: contact lenses"
11271012|NCT02719366|OG000|Outcome|Overall Study|Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.
11271013|NCT02719366|EG000|Reported Event|Comfilcon A Extended Range Test Lens|"Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.~comfilcon A Extended Range test lens: contact lenses"
11271014|NCT02719366|EG001|Reported Event|Comfilcon A Control Lens|"Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.~comfilcon A control lens: contact lenses"
11271015|NCT02719535|BG000|Baseline|Corneal Reshaping Therapy|Participants receiving Corneal Reshaping Therapy were monitored for ocular biometry and refractive errors throughout a 6-month period. Corneal stiffness and tangent modulus were outcome measures.
11271016|NCT02719535|FG000|Participant Flow|Corneal Reshaping Therapy|"Subjects will be wearing corneal reshaping lenses for the correction of their myopia~Corneal reshaping therapy: Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses"
11271017|NCT02719535|OG000|Outcome|Treatment|Treatment
11271018|NCT02719535|EG000|Reported Event|Treatment|Treatment
11271019|NCT02719639|BG000|Baseline|Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram|Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
11271020|NCT02719639|FG000|Participant Flow|Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram|Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
11271021|NCT02719639|OG000|Outcome|Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram|Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
11271022|NCT02719639|EG000|Reported Event|Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram|Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
11271023|NCT02719743|BG000|Baseline|H5N1 Formulation 1 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
11271024|NCT02719743|BG001|Baseline|H5N1 Formulation 2 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271025|NCT02719743|BG002|Baseline|H5N1 Formulation 3 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271026|NCT02719743|BG003|Baseline|H5N1 Formulation 4 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271027|NCT02719743|BG004|Baseline|H5N1 Formulation 5 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271028|NCT02719743|BG005|Baseline|Total|Total of all reporting groups
11271029|NCT02719743|FG000|Participant Flow|H5N1 Formulation 1 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
11271030|NCT02719743|FG001|Participant Flow|H5N1 Formulation 2 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271031|NCT02719743|FG002|Participant Flow|H5N1 Formulation 3 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271032|NCT02719743|FG003|Participant Flow|H5N1 Formulation 4 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271033|NCT02719743|FG004|Participant Flow|H5N1 Formulation 5 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271034|NCT02719743|OG000|Outcome|H5N1 Formulation 1 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
11271035|NCT02719743|OG001|Outcome|H5N1 Formulation 2 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271036|NCT02719743|OG002|Outcome|H5N1 Formulation 3 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271037|NCT02719743|OG003|Outcome|H5N1 Formulation 4 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271038|NCT02719743|OG004|Outcome|H5N1 Formulation 5 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271039|NCT02719743|EG000|Reported Event|H5N1 Formulation 1 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
11271040|NCT02719743|EG001|Reported Event|H5N1 Formulation 2 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271041|NCT02719743|EG002|Reported Event|H5N1 Formulation 3 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271042|NCT02719743|EG003|Reported Event|H5N1 Formulation 4 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271043|NCT02719743|EG004|Reported Event|H5N1 Formulation 5 Group|Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
11271044|NCT02719938|BG000|Baseline|Specialty Palliative Care|"Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.~Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers."
11271045|NCT02719938|BG001|Baseline|Control|Usual care.
11271046|NCT02719938|BG002|Baseline|Total|Total of all reporting groups
11271047|NCT02719938|FG000|Participant Flow|Specialty Palliative Care|"Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.~Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers."
11271048|NCT02719938|FG001|Participant Flow|Control|Usual care.
11271049|NCT02719938|OG000|Outcome|Specialty Palliative Care|"Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.~Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers."
11271050|NCT02719938|OG001|Outcome|Control|Usual care.
11271051|NCT02719938|EG000|Reported Event|Specialty Palliative Care|"Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.~Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers."
11271052|NCT02719938|EG001|Reported Event|Control|Usual care.
11271053|NCT02720042|BG000|Baseline|Phasix™ Mesh|"Patients treated with Phasix™ Mesh for hernia repair~Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)"
11271054|NCT02720042|FG000|Participant Flow|Phasix™ Mesh|"Patients treated with Phasix™ Mesh for hernia repair~Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)"
11271055|NCT02720042|OG000|Outcome|Phasix™ Mesh|"Patients treated with Phasix™ Mesh for hernia repair~Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)"
11271056|NCT02720042|EG000|Reported Event|Phasix™ Mesh|"Patients treated with Phasix™ Mesh for hernia repair~Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)"
11271057|NCT02720081|BG000|Baseline|MK-1029 150 mg + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271058|NCT02720081|BG001|Baseline|MK-1029 Placebo + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271059|NCT02720081|BG002|Baseline|Total|Total of all reporting groups
11271060|NCT02720081|FG000|Participant Flow|MK-1029 150 mg + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271061|NCT02720081|FG001|Participant Flow|MK-1029 Placebo + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271062|NCT02720081|OG000|Outcome|MK-1029 150 mg + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271063|NCT02720081|OG001|Outcome|MK-1029 Placebo + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271064|NCT02720081|EG000|Reported Event|MK-1029 150 mg + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271065|NCT02720081|EG001|Reported Event|MK-1029 Placebo + Montelukast 10 mg|Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
11271066|NCT02720107|BG000|Baseline|Fingolimod|Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).
11271067|NCT02720107|FG000|Participant Flow|Fingolimod|Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).
11271068|NCT02720107|OG000|Outcome|Fingolimod|Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).
11271069|NCT02720107|EG000|Reported Event|Fingolimod 0.5 mg|fingolimod 0.5 mg
11271070|NCT02720198|BG000|Baseline|Levomilnacipran|Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
11271071|NCT02720198|BG001|Baseline|Quetiapine|Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
11271072|NCT02720198|BG002|Baseline|Total|Total of all reporting groups
10847349|NCT00282841|FG000|Participant Flow|All Stroke Code Patients|Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
11271073|NCT02720198|FG000|Participant Flow|Levomilnacipran|Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
11271074|NCT02720198|FG001|Participant Flow|Quetiapine|Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
11271075|NCT02720198|OG000|Outcome|Levomilnacipran|Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
11271076|NCT02720198|OG001|Outcome|Quetiapine|Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
11271077|NCT02720198|EG000|Reported Event|Levomilnacipran|Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
11271078|NCT02720198|EG001|Reported Event|Quetiapine|Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
11271079|NCT02720224|BG000|Baseline|Estetrol|"A single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C~Estetrol: 15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C"
11271080|NCT02720224|FG000|Participant Flow|Estetrol|"A single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C~Estetrol: 15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C"
11271081|NCT02720224|OG000|Outcome|Estetrol|"A single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C~Estetrol: 15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C"
11271082|NCT02720224|EG000|Reported Event|Estetrol|"A single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C~Estetrol: 15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C"
11271083|NCT02720484|BG000|Baseline|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11271084|NCT02720484|FG000|Participant Flow|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11271085|NCT02720484|OG000|Outcome|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11271086|NCT02720484|EG000|Reported Event|Treatment (Nivolumab)|"Patients receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV"
11271110|NCT02720536|BG000|Baseline|Deferasirox|Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
11271111|NCT02720536|FG000|Participant Flow|Deferasirox|Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
11271112|NCT02720536|OG000|Outcome|Deferasirox|Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
11271113|NCT02720536|OG000|Outcome|Baseline|Baseline of laboratory value
11271114|NCT02720536|OG001|Outcome|Month 6|Change from baseline at month 6
11271115|NCT02720536|OG002|Outcome|Month 12|Change from baseline at month 12
11271116|NCT02720536|OG000|Outcome|Baseline|Serum ferritin value at baseline
11271117|NCT02720536|OG001|Outcome|Month 6|Serum ferritin value at baseline and at month 6
11271118|NCT02720536|OG002|Outcome|Month 12|Serum ferritin value at baseline and at month 12
11271119|NCT02720536|EG000|Reported Event|Deferasirox|Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
11271120|NCT02720627|BG000|Baseline|CB-03-01 Cream, 1%|"Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days~cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder."
11271121|NCT02720627|FG000|Participant Flow|CB-03-01 Cream, 1%|"Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days~cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder."
11271122|NCT02720627|OG000|Outcome|CB-03-01 Cream, 1%|"Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days~cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder."
11271123|NCT02720627|EG000|Reported Event|CB-03-01 Cream, 1%|"Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days~cortexolone 17α-propionate (USAN/INN: clasocoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder."
11271124|NCT02720757|BG000|Baseline|Tiotropium + Olodaterol FDC|"Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.~Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use"
11271125|NCT02720757|FG000|Participant Flow|Tiotropium + Olodaterol FDC|"Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.~Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use"
11271126|NCT02720757|OG000|Outcome|Tiotropium + Olodaterol FDC|"Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.~Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use"
11271127|NCT02720757|EG000|Reported Event|Tiotropium + Olodaterol FDC|"Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.~Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use"
11271128|NCT02721017|BG000|Baseline|Cryoanalgesia|"Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure~Cryoanalgesia"
11271129|NCT02721017|BG001|Baseline|Thoracic Epidural|"Thoracic epidural (ropivicaine, fentanyl).~Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl."
11271130|NCT02721017|BG002|Baseline|Total|Total of all reporting groups
11271131|NCT02721017|FG000|Participant Flow|Cryoanalgesia|"Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure~Cryoanalgesia"
11271132|NCT02721017|FG001|Participant Flow|Thoracic Epidural|"Thoracic epidural (ropivicaine, fentanyl).~Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl."
11271133|NCT02721017|OG000|Outcome|Cryoanalgesia|Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure.
11271134|NCT02721017|OG001|Outcome|Thoracic Epidural|"Thoracic epidural (ropivicaine, fentanyl).~Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl."
11271135|NCT02721017|OG000|Outcome|Cryoanalgesia|"Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure~Cryoanalgesia"
11271136|NCT02721017|OG000|Outcome|Cryoanalgesia|Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
11271137|NCT02721017|EG000|Reported Event|Cryoanalgesia|"Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure~Cryoanalgesia"
11271138|NCT02721017|EG001|Reported Event|Thoracic Epidural|"Thoracic epidural (ropivicaine, fentanyl).~Thoracic epidural (ropivicaine, fentanyl): Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl."
11271139|NCT02721147|BG000|Baseline|Intimacy Enhancing Intervention|Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
11271140|NCT02721147|BG001|Baseline|Living Healthy Together|Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
11271141|NCT02721147|BG002|Baseline|Developmental Substudy|Study-eligible patients who refuse participation in the intervention study were asked to complete a one-time survey assessing reasons for refusal and preferences for obtaining support about sexual concerns. Baseline characteristics were collected for this arm. No primary or secondary outcome measures were collected.
11271142|NCT02721147|BG003|Baseline|Total|Total of all reporting groups
11271143|NCT02721147|FG000|Participant Flow|Intimacy Enhancing Intervention|Participants attend 4 60-75 minute intimacy enhancement intervention weekly sessions delivered over the telephone to both members of the couple. The intimacy enhancement intervention content covers the following main topics: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Written handouts are sent to participants included session handouts in advance of the scheduled session. Participants are encouraged to participate in written and behavioral activities at home.
11271144|NCT02721147|FG001|Participant Flow|Living Healthy Together|Participants attend 4 60-75 minute educational and support weekly sessions delivered over the telephone to both members of the couple. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Written materials are sent to participants in advance of each session. Participants are encouraged to read educational materials and engage in the sessions with the counselor through active discussions.
11271145|NCT02721147|FG002|Participant Flow|Developmental Substudy|Study-eligible refusers were offered the opportunity to complete a one-time survey assessing reasons for refusal and preferences for obtaining support for sexual concerns. Primary and secondary outcome measures were not collected from these participants.
11271146|NCT02721147|OG000|Outcome|Participants Eligible For Enrollment|Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.
11271147|NCT02721147|OG000|Outcome|Intimacy Enhancing Intervention|Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
11271148|NCT02721147|OG001|Outcome|Educational Control|Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
11271149|NCT02721147|OG001|Outcome|Living Healthy Together|Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
11271150|NCT02721147|EG000|Reported Event|Intimacy Enhancing Intervention|Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex/intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
11271151|NCT02721147|EG001|Reported Event|Educational Control|Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
11271152|NCT02721251|BG000|Baseline|Weight Loss|"16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement~Weight Loss: 16 week. the goal is 10% weight loss."
11271153|NCT02721251|BG001|Baseline|Exercise|"16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week~Exercise: 16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)"
11271154|NCT02721251|BG002|Baseline|Exercise + Weight Loss|"Combined components of the exercise and weight loss treatments~Exercise + Weight Loss: Combined exercise and weight loss components of the other arms"
11271155|NCT02721251|BG003|Baseline|Total|Total of all reporting groups
11271156|NCT02721251|FG000|Participant Flow|Weight Loss|"16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement~Weight Loss: 16 week. the goal is 10% weight loss."
11271157|NCT02721251|FG001|Participant Flow|Exercise|"16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week~Exercise: 16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)"
11271158|NCT02721251|FG002|Participant Flow|Exercise + Weight Loss|"Combined components of the exercise and weight loss treatments~Exercise + Weight Loss: Combined exercise and weight loss components of the other arms"
11271159|NCT02721251|OG000|Outcome|Weight Loss|16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement Weight Loss: 16 week. the goal is 10% weight loss.
11271160|NCT02721251|OG001|Outcome|Exercise|"16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week~Exercise: 16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)"
11271161|NCT02721251|OG002|Outcome|Exercise + Weight Loss|"Combined components of the exercise and weight loss treatments~Exercise + Weight Loss: Combined exercise and weight loss components of the other arms"
11271162|NCT02721251|OG000|Outcome|Weight Loss|"16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement~Weight Loss: 16 week. the goal is 10% weight loss."
11271163|NCT02721251|EG000|Reported Event|Weight Loss|"16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement~Weight Loss: 16 week. the goal is 10% weight loss."
11271164|NCT02721251|EG001|Reported Event|Exercise|"16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week~Exercise: 16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)"
11271165|NCT02721251|EG002|Reported Event|Exercise + Weight Loss|"Combined components of the exercise and weight loss treatments~Exercise + Weight Loss: Combined exercise and weight loss components of the other arms"
11271166|NCT02721355|BG000|Baseline|Food Supplement GastimunHP|"The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime~GastimunHP: Health food supplement containing specific IgY against urease of H. pylori"
11271167|NCT02721355|BG001|Baseline|Control|The subjects undergo the routine treatment regime without taking food supplement
11271168|NCT02721355|BG002|Baseline|Total|Total of all reporting groups
11271169|NCT02721355|FG000|Participant Flow|Food Supplement GastimunHP|"The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime~GastimunHP: Health food supplement containing specific IgY against urease of H. pylori"
11271170|NCT02721355|FG001|Participant Flow|Control|The subjects undergo the routine treatment regime without taking food supplement
11271171|NCT02721355|OG000|Outcome|Food Supplement GastimunHP|"The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime~GastimunHP: Health food supplement containing specific IgY against urease of H. pylori"
11271172|NCT02721355|OG001|Outcome|Control|The subjects undergo the routine treatment regime without taking food supplement
11271173|NCT02721355|EG000|Reported Event|Food Supplement GastimunHP|"The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime~GastimunHP: Health food supplement containing specific IgY against urease of H. pylori"
11271174|NCT02721355|EG001|Reported Event|Control|The subjects undergo the routine treatment regime without taking food supplement
11271175|NCT02721641|BG000|Baseline|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
11271176|NCT02721641|FG000|Participant Flow|Herceptin|Participants received intravenous (IV) Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
11271177|NCT02721641|OG000|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
11271178|NCT02721641|EG000|Reported Event|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
11271179|NCT02721875|BG000|Baseline|Volasertib Monotherapy|Subject received volasertib with starting dose of 110 mg/meter square (m2) in solution for intravenous infusion (350 milligram (mg)/175 milliliter (mL) vial (2.0 mg/mL)), on day 1 + 8, 28-day cycle
11271180|NCT02721875|BG001|Baseline|Volasertib + Azacitidine Combination|Subject received volasertib with starting dose 170 mg/m2 on day 8 in combination with subcutaneous (s.c.) or intravenous administration of azacitidine 75 mg/m2 once daily for 7 consecutive days (days 1-7), 28-day cycle
11271181|NCT02721875|BG002|Baseline|Total|Total of all reporting groups
11271182|NCT02721875|FG000|Participant Flow|Volasertib Monotherapy|Subject received volasertib with starting dose of 110 mg/meter square (m2) in solution for intravenous infusion (350 milligram (mg)/175 milliliter (mL) vial (2.0 mg/mL)), on day 1 + 8, 28-day cycle
11271183|NCT02721875|FG001|Participant Flow|Volasertib + Azacitidine Combination|Subject received volasertib with starting dose 170 mg/m2 on day 8 in combination with subcutaneous (s.c.) or intravenous administration of azacitidine 75 mg/m2 once daily for 7 consecutive days (days 1-7), 28-day cycle
11271184|NCT02721875|OG000|Outcome|Volasertib Monotherapy|Subject received volasertib with starting dose of 110 mg/meter square (m2) in solution for intravenous infusion (350 milligram (mg)/175 milliliter (mL) vial (2.0 mg/mL)), on day 1 + 8, 28-day cycle
11271185|NCT02721875|OG001|Outcome|Volasertib + Azacitidine Combination|Subject received volasertib with starting dose 170 mg/m2 on day 8 in combination with subcutaneous (s.c.) or intravenous administration of azacitidine 75 mg/m2 once daily for 7 consecutive days (days 1-7), 28-day cycle
11271186|NCT02721875|OG000|Outcome|Volasertib + Azacitidine Combination|Subject received volasertib with starting dose 170 mg/m2 on day 8 in combination with subcutaneous (s.c.) or intravenous administration of azacitidine 75 mg/m2 once daily for 7 consecutive days (days 1-7), 28-day cycle
11271187|NCT02721875|EG000|Reported Event|Volasertib Monotherapy|Subject received volasertib with starting dose of 110 mg/meter square (m2) in solution for intravenous infusion (350 milligram (mg)/175 milliliter (mL) vial (2.0 mg/mL)), on day 1 + 8, 28-day cycle
11271188|NCT02721966|BG000|Baseline|AIN457 300mg|Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48
11271189|NCT02721966|BG001|Baseline|AIN457 150mg|Secukinumab 150 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 150 mg injections every 4 weeks between week 8 and week 48
11271190|NCT02721966|BG002|Baseline|Placebo AIN457|Placebo sc. injections at baseline and weekly until Week 4, then at Week 8 and followed by Secukinumab 300 mg or 150 mg injections every 4 weeks between week 12 and week 48
11271191|NCT02721966|BG003|Baseline|Total|Total of all reporting groups
11271192|NCT02721966|FG000|Participant Flow|AIN457 300mg|Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48
11271193|NCT02721966|FG001|Participant Flow|AIN457 150mg|Secukinumab 150 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 150 mg injections every 4 weeks between week 8 and week 48
11271194|NCT02721966|FG002|Participant Flow|Placebo AIN457 300 mg|Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 300 mg sc injection every 4 week for remaining 40 weeks.
11271195|NCT02721966|FG003|Participant Flow|Placebo AIN457 150 mg|Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg sc injection every 4 week for remaining 40 weeks.
11271196|NCT02721966|FG004|Participant Flow|Placebo|Placebo sc injections at baseline and weekly until Week 8
11271197|NCT02721966|OG000|Outcome|AIN457 150mg|Secukinumab 150 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 150 mg injections every 4 weeks between week 8 and week 48
11271198|NCT02721966|OG001|Outcome|AIN457 300mg|Secukinumab 300 mg sc injections at baseline and weekly until 4 weeks followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48
11271199|NCT02721966|OG002|Outcome|Placebo AIN457|Placebo sc. injections at baseline and weekly until Week 4, then at Week 8 and followed by Secukinumab 300 mg or 150 mg injections every 4 weeks between week 12 and week 48
11271200|NCT02721966|EG000|Reported Event|Secukinumab 300 mg|Secukinumab 300 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 300 mg injections every 4 weeks between week 8 and week 48 and placebo-switchers to Secukinumab at week 12 onwards
10970197|NCT00909363|FG001|Participant Flow|WAS Patients for Blood Drawing Only|patients with WAS whose parents did not want them to receive treatment but were willing to let them have their blood drawn to increase the number of patients studied for platelet parameters with WAS
11271201|NCT02721966|EG001|Reported Event|Secukinumab 150 mg|Secukinumab 150 mg sc. injections at baseline and weekly until Week 4 followed by Secukinumab 150 mg injections every 4 weeks between week 8 and week 48 and placebo-switchers to Secukinumab at week 12 onwards
11271202|NCT02721966|EG002|Reported Event|Placebo|Placebo sc. injections at baseline and weekly until Week 4, then at Week 8
11271203|NCT02722044|BG000|Baseline|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
11271204|NCT02722044|FG000|Participant Flow|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
11271205|NCT02722044|OG000|Outcome|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
11271206|NCT02722044|OG000|Outcome|M923 40 mg|Participants self-administered 40 mg of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
11271207|NCT02722044|EG000|Reported Event|M923 40 mg|Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
11271208|NCT02722148|BG000|Baseline|Enrolled Patients|"All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy~Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE)."
11271209|NCT02722148|FG000|Participant Flow|Enrolled Patients|"All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy~Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE)."
11271210|NCT02722148|OG000|Outcome|Enrolled Patients|"All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy~Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE)."
11271211|NCT02722148|EG000|Reported Event|Enrolled Patients|"All enrolled subjects will receive a novel allergen-specific immune signature directed approach to dietary elimination therapy~Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy: A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE)."
11271212|NCT02722239|BG000|Baseline|T Drug First / Then Drug R|Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period took the study test product (Т), and on the second study period after wash out period of 7 days the volunteers were given the Reference product (R)
11271213|NCT02722239|BG001|Baseline|R Drug First / Then Drug T|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 were administered with the study drug in reverse order. It means that group 1 took the study products in sequence T-R and group 2 in the sequence R-T.
11271214|NCT02722239|BG002|Baseline|Total|Total of all reporting groups
11271215|NCT02722239|FG000|Participant Flow|T Drug First / Then Drug R|Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period took the study test product (Т), and on the second study period after wash out period of 7 days the volunteers were given the Reference product (R)
10970198|NCT00909363|FG002|Participant Flow|Healthy Children|platelet parameters (primarily function) needed normal controls in children-----three were pre-op and two siblings were being tested as potential bone marrow donors
11271216|NCT02722239|FG001|Participant Flow|R Drug First / Then Drug T|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 were administered with the study drug in reverse order. It means that group 1 took the study products in sequence T-R and group 2 in the sequence R-T.
11271217|NCT02722239|OG000|Outcome|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
11271218|NCT02722239|OG001|Outcome|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
11271219|NCT02722239|OG000|Outcome|T Drug vs R Drug|Ratio of Test product (a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release) and Reference product (co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long)).
11271220|NCT02722239|EG000|Reported Event|Test Product (T)|Test Product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release.
11271221|NCT02722239|EG001|Reported Event|Reference Product (R)|Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
11271222|NCT02722278|BG000|Baseline|Oral Testosterone Undecanoate|"Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271223|NCT02722278|BG001|Baseline|Axiron Testosterone Topical Solution|"Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271224|NCT02722278|BG002|Baseline|Total|Total of all reporting groups
11271225|NCT02722278|FG000|Participant Flow|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11092295|NCT01539070|BG000|Baseline|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
11271226|NCT02722278|FG001|Participant Flow|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271227|NCT02722278|OG000|Outcome|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271228|NCT02722278|OG001|Outcome|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271229|NCT02722278|OG000|Outcome|Oral TU Cosyntropin Substudy Subjects|Subjects receiving Oral TU participating in cosyntropin substudy
11271230|NCT02722278|OG001|Outcome|Axiron Cosyntropin Substudy Subjects|
11271231|NCT02722278|EG000|Reported Event|Oral Testosterone Undecanoate|"166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271232|NCT02722278|EG001|Reported Event|Axiron Testosterone Topical Solution|"56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
11271233|NCT02722304|BG000|Baseline|ARALAST NP 60 mg/kg (Group 1)|Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
11271234|NCT02722304|BG001|Baseline|ARALAST NP 120 mg/kg (Group 2)|Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
11271235|NCT02722304|BG002|Baseline|GLASSIA 60 mg/kg (Group 3)|Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271236|NCT02722304|BG003|Baseline|GLASSIA 120 mg/kg (Group 4)|Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271237|NCT02722304|BG004|Baseline|Placebo (Group 5)|Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent [%]) in normal saline for a total of 96 weeks.
11271238|NCT02722304|BG005|Baseline|Total|Total of all reporting groups
11271239|NCT02722304|FG000|Participant Flow|ARALAST NP 60 mg/kg (Group 1)|Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
11271240|NCT02722304|FG001|Participant Flow|ARALAST NP 120 mg/kg (Group 2)|Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
11271241|NCT02722304|FG002|Participant Flow|GLASSIA 60 mg/kg (Group 3)|Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271242|NCT02722304|FG003|Participant Flow|GLASSIA 120 mg/kg (Group 4)|Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271243|NCT02722304|FG004|Participant Flow|Placebo (Group 5)|Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent [%]) in normal saline for a total of 96 weeks.
11271244|NCT02722304|OG000|Outcome|ARALAST NP 60 mg/kg Versus Placebo|Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent [%]) in normal saline for a total of 96 weeks.
11271245|NCT02722304|OG001|Outcome|GLASSIA 60 mg/kg Versus Placebo|Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
11271246|NCT02722304|OG002|Outcome|GLASSIA 120 mg/kg Versus Placebo|Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
11271247|NCT02722304|OG000|Outcome|ARALAST NP 60 mg/kg (Group 1)|Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
11271248|NCT02722304|OG001|Outcome|GLASSIA 60 mg/kg (Group 3)|Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271249|NCT02722304|OG002|Outcome|GLASSIA 120 mg/kg (Group 4)|Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271250|NCT02722304|OG003|Outcome|Placebo (Group 5)|Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent [%]) in normal saline for a total of 96 weeks.
11271251|NCT02722304|EG000|Reported Event|ARALAST NP 60 mg/kg (Group 1)|Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
11271252|NCT02722304|EG001|Reported Event|ARALAST NP 120 mg/kg (Group 2)|Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
11271253|NCT02722304|EG002|Reported Event|GLASSIA 60 mg/kg (Group 3)|Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271254|NCT02722304|EG003|Reported Event|GLASSIA 120 mg/kg (Group 4)|Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
11271255|NCT02722304|EG004|Reported Event|Placebo (Group 5)|Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent [%]) in normal saline for a total of 96 weeks.
11271256|NCT02722330|BG000|Baseline|Baha 5 SuperPower on Baha Attract System|"The device involves the following parts:~The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.~Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling."
11337605|NCT03588910|EG000|Reported Event|Number of Oxycodone Tablets Typically Prescribed|"Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11271257|NCT02722330|FG000|Participant Flow|Baha 5 SuperPower on Baha Attract System|"The device involves the following parts:~The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.~Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling."
11271258|NCT02722330|OG000|Outcome|Baha 5 SuperPower on Baha Attract System|"The device involves the following parts:~The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.~Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling."
11271259|NCT02722330|EG000|Reported Event|Baha 5 SuperPower on Baha Attract System|"The device involves the following parts:~The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.~Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling."
11271260|NCT02722408|BG000|Baseline|Gemcabene|Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84.
11271261|NCT02722408|FG000|Participant Flow|Gemcabene|"Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 milligram (mg) of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84.~Participants were followed until Day 112."
11271262|NCT02722408|OG000|Outcome|Gemcabene|Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84.
11271263|NCT02722408|EG000|Reported Event|Gemcabene 300 mg|Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28.
11271264|NCT02722408|EG001|Reported Event|Gemcabene 600 mg|Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 600 mg of Gemcabene, orally once daily from day 29 to 56.
11271265|NCT02722408|EG002|Reported Event|Gemcabene 900 mg|Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 900 mg of Gemcabene, orally once daily from day 57 to 84.
11271266|NCT02722499|BG000|Baseline|High Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure~High Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65."
11271267|NCT02722499|BG001|Baseline|Moderate Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure~Moderate Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85"
11092296|NCT01539070|BG001|Baseline|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
11092297|NCT01539070|BG002|Baseline|Total|Total of all reporting groups
11271268|NCT02722499|BG002|Baseline|Low Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure~Low Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150."
11271269|NCT02722499|BG003|Baseline|Total|Total of all reporting groups
11271270|NCT02722499|FG000|Participant Flow|High Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure~High Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65."
11271271|NCT02722499|FG001|Participant Flow|Moderate Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure~Moderate Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85"
11271272|NCT02722499|FG002|Participant Flow|Low Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure~Low Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150."
11271273|NCT02722499|OG000|Outcome|High Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure~High Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65."
11271274|NCT02722499|OG001|Outcome|Moderate Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure~Moderate Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85"
11271275|NCT02722499|OG002|Outcome|Low Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure~Low Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150."
11271276|NCT02722499|EG000|Reported Event|High Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure~High Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65."
11271277|NCT02722499|EG001|Reported Event|Moderate Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure~Moderate Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85"
11271278|NCT02722499|EG002|Reported Event|Low Frequency Financial Incentive|"This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure~Low Frequency Financial Incentive: 1. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.~2. Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150."
11271279|NCT02722564|BG000|Baseline|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
11271280|NCT02722564|FG000|Participant Flow|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
11271281|NCT02722564|OG000|Outcome|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
11271282|NCT02722564|EG000|Reported Event|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
11271283|NCT02722577|BG000|Baseline|Main Group|All patients enrolled in this study
11271284|NCT02722577|FG000|Participant Flow|Main Group|All patients enrolled in this study
11271285|NCT02722577|OG000|Outcome|Main Group|All patients enrolled in this study
11271286|NCT02722577|EG000|Reported Event|Main Group|All patients enrolled in this study
11271287|NCT02722837|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
11271288|NCT02722837|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks, with or without food
11271289|NCT02722837|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
11271290|NCT02722837|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
11271291|NCT02722863|BG000|Baseline|Safety Set|all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen
11271292|NCT02722863|FG000|Participant Flow|Samsca|"Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction.~Patients who are prescribed Samsca® treatment as per investigator's medical judgment Patients who gave written authorization to use their personal and health data Patients starting Samsca® treatment after agreement is in place"
11271293|NCT02722863|OG000|Outcome|Safety Set|a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
11271294|NCT02722863|OG000|Outcome|Efficacy Set|patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets.
11271295|NCT02722863|EG000|Reported Event|Safety Set|a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
11271296|NCT02722928|BG000|Baseline|Conventional 1:1 Oxygen/Air Gas Mixture|39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
11271297|NCT02722928|BG001|Baseline|Pure Oxygen Ventilation|31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (FiO2 = 100%) until extubation
11271298|NCT02722928|BG002|Baseline|Total|Total of all reporting groups
11271299|NCT02722928|FG000|Participant Flow|Conventional 1:1 Oxygen/Air Gas Mixture|39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
11271300|NCT02722928|FG001|Participant Flow|Pure Oxygen Ventilation|31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (FiO2 = 100%) until extubation
11271301|NCT02722928|OG000|Outcome|Conventional 1:1 Oxygen/Air Gas Mixture|39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
11271302|NCT02722928|OG001|Outcome|Pure Oxygen Ventilation|31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (FiO2 = 100%) until extubation
11271303|NCT02722928|OG000|Outcome|Conventional 1:1 Oxygen/Air Gas Mixture|Out of the 39 patients included in the Conventional 1:1 oxygen / air gas mixture ventilation group, 23 patients underwent conventional anterior fossa surgery. Pneumocephalus volume was compared between groups for this patient sub-setting
11271304|NCT02722928|OG001|Outcome|Pure Oxygen Ventilation|Out of the 31 patients in the pure oxygen ventilation after hemostasis group, 16 patients underwent conventional anterior fossa surgery. Pneumocephalus volume was compared between groups for this patient setting
11271305|NCT02722928|OG000|Outcome|Conventional 1:1 Oxygen / Air Gas Mixture Ventilation|Out of the 39 patients in the Conventional 1:1 oxygen / air gas mixture ventilation group, 15 patients underwent conventional posterior fossa surgery. Pneumocephalus volume was compared between groups for this patient sub-setting
11271306|NCT02722928|OG001|Outcome|Pure Oxygen Ventilation After Hemostasis|Out of the 31 patients in the pure oxygen ventilation after hemostasis group,11 patients underwent conventional posterior fossa surgery. Pneumocephalus volume was compared between groups for this patient sub-setting
11271307|NCT02722928|EG000|Reported Event|Conventional 1:1 Oxygen/Air Gas Mixture|39 patients received ventilation during the surgery with a 1:1 oxygen / air gas mixture
11271308|NCT02722928|EG001|Reported Event|Pure Oxygen Ventilation|31 patients received controlled ventilation with a conventional 1:1 oxygen / air gas mixture (60% oxygen concentration) during the approach and tumor removal phases. Once tumor resection was completed and hemostasis started, this group of patients was switched to ventilation with pure oxygen (100% oxygen concentration) until extubation
11271309|NCT02722967|BG000|Baseline|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with bipolar 1 disorder who were treated with oral aripiprazole.
11271310|NCT02722967|BG001|Baseline|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
11271311|NCT02722967|BG002|Baseline|Schizophrenia (SCH)|This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
11271312|NCT02722967|BG003|Baseline|Total|Total of all reporting groups
11271313|NCT02722967|FG000|Participant Flow|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole.
11271314|NCT02722967|FG001|Participant Flow|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
11271315|NCT02722967|FG002|Participant Flow|Schizophrenia (SCH)|This group consisted of the participants with SCH who were being treated with oral aripiprazole.
11271316|NCT02722967|OG000|Outcome|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with bipolar 1 disorder who were treated with oral aripiprazole
11271317|NCT02722967|OG001|Outcome|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of major depressive disorder who were treated with oral aripiprazole.
11271318|NCT02722967|OG002|Outcome|Schizophrenia (SCH)|This group consisted of the participants with schizophrenia who were treated with oral aripiprazole.
11271319|NCT02722967|EG000|Reported Event|Bipolar 1 Disorder (BP1)|This group consisted of the participants with acute treatment of manic and mixed episodes associated with BP1 who were being treated with oral aripiprazole.
11271320|NCT02722967|EG001|Reported Event|Major Depressive Disorder (MDD)|This group consisted of the participants with adjunctive treatment of MDD who were being treated with oral aripiprazole.
11271321|NCT02722967|EG002|Reported Event|Schizophrenia (SCH)|This group consisted of the participants with SCH who were being treated with oral aripiprazole.
11271322|NCT02723006|BG000|Baseline|Arm 1: TAK-580 + Nivolumab|Participants in this group received TAK-580 400 mg, tablets, orally, once weekly along with nivolumab 3 mg/kg, infusion, intravenous, once every 2 weeks (up to Week 48).
11271323|NCT02723006|BG001|Baseline|Arm 2: TAK-202 + Nivolumab|Participants in this group received TAK-202 (plozalizumab) 4 mg/kg titrated up to 8 mg/kg (stable dose), infusion, intravenous, once in Weeks 1, 3, 5, and every 4 weeks thereafter along with nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks (up to Week 50).
11271324|NCT02723006|BG002|Baseline|Arm 3: Vedolizumab + Ipilimumab + Nivolumab|Participants in this group received vedolizumab 200 mg titrated up to 450 mg (stable dose), infusion, intravenously, once in Weeks 1, 3, 5, and 13 along with ipilimumab 3 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses and nivolumab 1 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks until disease progression or unacceptable toxicity (up to Week 48).
11271325|NCT02723006|BG003|Baseline|Total|Total of all reporting groups
11271326|NCT02723006|FG000|Participant Flow|Arm 1: TAK-580 + Nivolumab|Participants in this group received TAK-580 400 milligram (mg), tablets, orally, once weekly along with nivolumab 3 milligram per kilogram (mg/kg), infusion, intravenous, once every 2 weeks (up to Week 48).
11271327|NCT02723006|FG001|Participant Flow|Arm 2: TAK-202 + Nivolumab|Participants in this group received TAK-202 (plozalizumab) 4 mg/kg titrated up to 8 mg/kg (stable dose), infusion, intravenous, once in Weeks 1, 3, 5, and every 4 weeks thereafter along with nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks (up to Week 50).
11271328|NCT02723006|FG002|Participant Flow|Arm 3: Vedolizumab + Ipilimumab + Nivolumab|Participants in this group received vedolizumab 200 mg titrated up to 450 mg (stable dose), infusion, intravenously, once in Weeks 1, 3, 5, and 13 along with ipilimumab 3 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses and nivolumab 1 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks until disease progression or unacceptable toxicity (up to Week 48).
11271329|NCT02723006|OG000|Outcome|Arm 1: TAK-580 + Nivolumab|Participants in this group received TAK-580 400 mg, tablets, orally, once weekly along with nivolumab 3 mg/kg, infusion, intravenous, once every 2 weeks (up to Week 48).
11271330|NCT02723006|OG001|Outcome|Arm 2: TAK-202 + Nivolumab|Participants in this group received TAK-202 (plozalizumab) 4 mg/kg titrated up to 8 mg/kg (stable dose), infusion, intravenous, once in Weeks 1, 3, 5, and every 4 weeks thereafter along with nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks (up to Week 50).
11271331|NCT02723006|OG002|Outcome|Arm 3: Vedolizumab + Ipilimumab + Nivolumab|Participants in this group received vedolizumab 200 mg titrated up to 450 mg (stable dose), infusion, intravenously, once in Weeks 1, 3, 5, and 13 along with ipilimumab 3 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses and nivolumab 1 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks until disease progression or unacceptable toxicity (up to Week 48).
11271332|NCT02723006|EG000|Reported Event|Arm 1: TAK-580 + Nivolumab|Participants in this group received TAK-580 400 mg, tablets, orally, once weekly along with nivolumab 3 mg/kg, infusion, intravenous, once every 2 weeks (up to Week 48).
11271333|NCT02723006|EG001|Reported Event|Arm 2: TAK-202 + Nivolumab|Participants in this group received TAK-202 (plozalizumab) 4 mg/kg titrated up to 8 mg/kg (stable dose), infusion, intravenous, once in Weeks 1, 3, 5, and every 4 weeks thereafter along with nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks (up to Week 50).
11271334|NCT02723006|EG002|Reported Event|Arm 3: Vedolizumab + Ipilimumab + Nivolumab|Participants in this group received vedolizumab 200 mg titrated up to 450 mg (stable dose), infusion, intravenously, once in Weeks 1, 3, 5, and 13 along with ipilimumab 3 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses and nivolumab 1 mg/kg, infusion, intravenously, once every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg, infusion, intravenously, once every 2 weeks until disease progression or unacceptable toxicity (up to Week 48).
11271335|NCT02723084|BG000|Baseline|Arm A|Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
11271336|NCT02723084|BG001|Baseline|Arm B|sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
11271337|NCT02723084|BG002|Baseline|Total|Total of all reporting groups
11271338|NCT02723084|FG000|Participant Flow|Arm A|Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
11271339|NCT02723084|FG001|Participant Flow|Arm B|sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
11271340|NCT02723084|OG000|Outcome|Arm A|Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
11271341|NCT02723084|OG001|Outcome|Arm B|sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
11271342|NCT02723084|EG000|Reported Event|ARM A|Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
11271343|NCT02723084|EG001|Reported Event|ARM B|sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
11271344|NCT02723175|BG000|Baseline|Sham tDCS Stimulation|"30 minutes of the sham transcranial Direct Current Stimulation~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271345|NCT02723175|BG001|Baseline|Anodal tDCS Stimulation of DLPFC|"30 minutes of the active transcranial Direct Current Stimulation (tDCS)~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271346|NCT02723175|BG002|Baseline|Total|Total of all reporting groups
11271347|NCT02723175|FG000|Participant Flow|Sham tDCS Stimulation|"30 minutes of the sham transcranial Direct Current Stimulation~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271348|NCT02723175|FG001|Participant Flow|Anodal tDCS Stimulation of DLPFC|"30 minutes of the active transcranial Direct Current Stimulation (tDCS)~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271349|NCT02723175|OG000|Outcome|Sham tDCS Stimulation|"30 minutes of the sham transcranial Direct Current Stimulation~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271350|NCT02723175|OG001|Outcome|Anodal tDCS Stimulation of DLPFC|"30 minutes of the active transcranial Direct Current Stimulation (tDCS)~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271351|NCT02723175|EG000|Reported Event|Sham tDCS Stimulation|"30 minutes of the sham transcranial Direct Current Stimulation~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271352|NCT02723175|EG001|Reported Event|Anodal tDCS Stimulation of DLPFC|"30 minutes of the active transcranial Direct Current Stimulation (tDCS)~Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people."
11271353|NCT02723188|BG000|Baseline|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
11271354|NCT02723188|BG001|Baseline|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
11271355|NCT02723188|BG002|Baseline|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
11271356|NCT02723188|BG003|Baseline|Total|Total of all reporting groups
11271357|NCT02723188|FG000|Participant Flow|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
11271358|NCT02723188|FG001|Participant Flow|DC (Direct Current)|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
11271359|NCT02723188|FG002|Participant Flow|AC (Alternating Current)|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
11271360|NCT02723188|OG000|Outcome|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
11271361|NCT02723188|OG001|Outcome|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
11271362|NCT02723188|OG002|Outcome|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
11271363|NCT02723188|EG000|Reported Event|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
11271364|NCT02723188|EG001|Reported Event|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
11271365|NCT02723188|EG002|Reported Event|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
11271366|NCT02723201|BG000|Baseline|Part 1: TAK-020 17.5 mg|TAK-020 17.5 mg, OS, under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, SDT, orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, IRT, orally, under fasted state, once on Day 1 of fourth intervention period.
11271367|NCT02723201|BG001|Baseline|Part 2- TAK-020 25 mg CCT: Fasted + Fed|TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
11271368|NCT02723201|BG002|Baseline|Part 2- TAK-020 25 mg CCT: Fed + Fasted|TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
11271369|NCT02723201|BG003|Baseline|Total|Total of all reporting groups
11271370|NCT02723201|FG000|Participant Flow|Part 1- TAK-020 17.5 mg: OS + CCT + SDT + IRT|TAK-020 17.5 milligram (mg), oral solution (OS), under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, solid dispersion tablets (SDT), orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, immediate release tablets (IRT), orally, under fasted state, once on Day 1 of fourth intervention period.
11271371|NCT02723201|FG001|Participant Flow|Part 2- TAK-020 25 mg CCT: Fasted + Fed|TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
11271372|NCT02723201|FG002|Participant Flow|Part 2- TAK-020 25 mg CCT: Fed + Fasted|TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
11271373|NCT02723201|OG000|Outcome|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
11271374|NCT02723201|OG001|Outcome|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
11271375|NCT02723201|OG002|Outcome|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
11271376|NCT02723201|OG003|Outcome|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
11271377|NCT02723201|OG004|Outcome|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
11271378|NCT02723201|OG005|Outcome|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
11271379|NCT02723201|EG000|Reported Event|Part 1: TAK-020 17.5 mg OS|TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
11271380|NCT02723201|EG001|Reported Event|Part 1: TAK-020 17.5 mg CCT|TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
11271381|NCT02723201|EG002|Reported Event|Part 1: TAK-020 17.5 mg SDT|TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
11271382|NCT02723201|EG003|Reported Event|Part 1: TAK-020 17.5 mg IRT|TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
11271383|NCT02723201|EG004|Reported Event|Part 2: TAK-020 25 mg CCT Fasted|TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
11271384|NCT02723201|EG005|Reported Event|Part 2: TAK-020 25 mg CCT Fed|TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
11271385|NCT02723344|BG000|Baseline|Placebo|Sham Probiotic
11271386|NCT02723344|BG001|Baseline|L Reuteri|Probiotic
11271387|NCT02723344|BG002|Baseline|Total|Total of all reporting groups
11271388|NCT02723344|FG000|Participant Flow|Placebo|Allocated to Placebo
11271389|NCT02723344|FG001|Participant Flow|L Reuteri|Allocated to L reuteri
11271390|NCT02723344|OG000|Outcome|Placebo|Allocated to Placebo
11271391|NCT02723344|OG001|Outcome|L Reuteri|Allocated to L reuteri
11271392|NCT02723344|EG000|Reported Event|Placebo|Allocated to Placebo
11271393|NCT02723344|EG001|Reported Event|L Reuteri|Allocated to L reuteri
11271394|NCT02723591|BG000|Baseline|Tacrolimus, Extended Release (Astagraf XL®) Once Daily|Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271395|NCT02723591|BG001|Baseline|Tacrolimus, Immediate Release BID|Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271396|NCT02723591|BG002|Baseline|Total|Total of all reporting groups
11271397|NCT02723591|FG000|Participant Flow|Tacrolimus, Extended Release (Astagraf XL®) Once Daily|Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 milligram per kilogram (mg/kg), once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 nanogram per milliliter (ng/mL) at all times during the study.
11271398|NCT02723591|FG001|Participant Flow|Tacrolimus, Immediate Release Twice Daily (BID)|Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271399|NCT02723591|OG000|Outcome|Tacrolimus, Extended Release (Astagraf XL®) Once Daily|Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271400|NCT02723591|OG001|Outcome|Tacrolimus, Immediate Release BID|Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271401|NCT02723591|EG000|Reported Event|Tacrolimus, Extended Release (Astagraf XL®) Once Daily|Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271402|NCT02723591|EG001|Reported Event|Tacrolimus, Immediate Release BID|Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
11271403|NCT02723630|BG000|Baseline|Sequence A|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence A were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level <4%), Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), and Treatment 3 (high Crystal form Type-C level 38%) on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271404|NCT02723630|BG001|Baseline|Sequence B|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence B were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 1 (low Crystal form Type-C level <4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11337357|NCT03582943|BG001|Baseline|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11271405|NCT02723630|BG002|Baseline|Sequence C|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence C were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 1 (low Crystal form Type-C level <4%), and Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271406|NCT02723630|BG003|Baseline|Sequence D|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence D were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), and Treatment 1 (low Crystal form Type-C level <4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271407|NCT02723630|BG004|Baseline|Sequence E|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence E were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level <4%), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271408|NCT02723630|BG005|Baseline|Sequence F|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence F were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), Treatment 1 (low Crystal form Type-C level <4%), and Treatment 3 (high Crystal form Type-C level 38%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271409|NCT02723630|BG006|Baseline|Total|Total of all reporting groups
11271410|NCT02723630|FG000|Participant Flow|Sequence A|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence A were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level <4%), Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), and Treatment 3 (high Crystal form Type-C level 38%) on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271411|NCT02723630|FG001|Participant Flow|Sequence B|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence B were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 1 (low Crystal form Type-C level <4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271412|NCT02723630|FG002|Participant Flow|Sequence C|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence C were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 1 (low Crystal form Type-C level <4%), and Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11337358|NCT03582943|BG002|Baseline|Total|Total of all reporting groups
11271413|NCT02723630|FG003|Participant Flow|Sequence D|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence D were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), and Treatment 1 (low Crystal form Type-C level <4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271414|NCT02723630|FG004|Participant Flow|Sequence E|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence E were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level <4%), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271415|NCT02723630|FG005|Participant Flow|Sequence F|The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence F were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches), Treatment 1 (low Crystal form Type-C level <4%), and Treatment 3 (high Crystal form Type-C level 38%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11271416|NCT02723630|OG000|Outcome|Treatment 1: Low Crystal Form|Treatment 1: low Crystal form Type-C level < 4%
11271417|NCT02723630|OG001|Outcome|Treatment 2: Reference Crystal Form|Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
11271418|NCT02723630|OG002|Outcome|Treatment 3: High Crystal Form|Treatment 3: high Crystal form Type-C level 38%
11271419|NCT02723630|OG000|Outcome|Treatment 1: Low Crystal Form|Treatment 1: low Crystal form Type-C level <4%
11271420|NCT02723630|OG001|Outcome|Treatment 2: Reference Crystal Form|Treatment 2: reference* Crystal form Type-C level 15%, *reference range determined from clinical batches
11271421|NCT02723630|OG000|Outcome|Treatment 1: Low Crystal Form|Treatment 1: (low Crystal form Type-C level <4%)
11271422|NCT02723630|OG001|Outcome|Treatment 2: Reference Crystal Form|Treatment 2: (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches)
11271423|NCT02723630|OG002|Outcome|Treatment 3: High Crystal Form|Treatment 3: (high Crystal form Type-C level 38%)
11271424|NCT02723630|EG000|Reported Event|Treatment 1: Low Crystal Form|Treatment 1: (low Crystal form Type-C level <4%)
11271425|NCT02723630|EG001|Reported Event|Treatment 2: Reference Crystal Form|Treatment 2: (reference* Crystal form Type-C level 15%, *reference range determined from clinical batches)
11271426|NCT02723630|EG002|Reported Event|Treatment 3: High Crystal Form|Treatment 3: (high Crystal form Type-C level 38%)
11271427|NCT02723786|BG000|Baseline|GSK1070806 3 mg/kg IV|Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
11271428|NCT02723786|FG000|Participant Flow|GSK1070806 3 mg/kg IV|Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
11271429|NCT02723786|OG000|Outcome|GSK1070806 3 mg/kg IV|Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
11271430|NCT02723786|EG000|Reported Event|GSK1070806 3 mg/kg IV|Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
11271431|NCT02723916|BG000|Baseline|Intervention: ezParent Program|ezParent Program: Tablet-based behavioral parent training program.
11271432|NCT02723916|BG001|Baseline|Control: Health-e Kids App|Health-e Kids Control App: Tablet based health promotion information App
11271433|NCT02723916|BG002|Baseline|Total|Total of all reporting groups
11271434|NCT02723916|FG000|Participant Flow|Intervention: ezParent Program|ezParent Program: Tablet-based behavioral parent training program.
11271435|NCT02723916|FG001|Participant Flow|Control: Health-e Kids App|Health-e Kids Control App: Tablet based health promotion information App
11271436|NCT02723916|OG000|Outcome|Intervention: ezParent Program|ezParent Program: Tablet-based behavioral parent training program.
11271437|NCT02723916|OG001|Outcome|Control: Health-e Kids App|Health-e Kids Control App: Tablet based health promotion information App
11271438|NCT02723916|EG000|Reported Event|Intervention: ezParent Program|ezParent Program: Tablet-based behavioral parent training program.
11271439|NCT02723916|EG001|Reported Event|Control: Health-e Kids App|Health-e Kids Control App: Tablet based health promotion information App
11271440|NCT02723929|BG000|Baseline|Active Electrical Stim/Active Ultrasound|"Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.~active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
11271441|NCT02723929|BG001|Baseline|Sham Electrical Stim/Sham Ultrasound|"Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.~Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
11271442|NCT02723929|BG002|Baseline|Total|Total of all reporting groups
11271443|NCT02723929|FG000|Participant Flow|Active Electrical Stim/Active Ultrasound|"Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.~Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
11271444|NCT02723929|FG001|Participant Flow|Sham Electrical Stim/Sham Ultrasound|"Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.~Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
11271445|NCT02723929|OG000|Outcome|Active Electrical Stim/Active Ultrasound|"Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.~Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
11271446|NCT02723929|OG001|Outcome|Sham Electrical Stim/Sham Ultrasound|"Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.~Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
11271447|NCT02723929|OG000|Outcome|Active Electrical Stim/Active Ultrasound|"Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.~active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
11271448|NCT02723929|OG001|Outcome|Sham Electrical Stim/Sham Ultrasound|"Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.~Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
11271449|NCT02723929|EG000|Reported Event|Active Electrical Stim/Active Ultrasound|"Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.~active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
11271450|NCT02723929|EG001|Reported Event|Sham Electrical Stim/Sham Ultrasound|"Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.~Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.~Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
11271451|NCT02724020|BG000|Baseline|Arm A: Single-agent Everolimus 10 mg QD|Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
11271452|NCT02724020|BG001|Baseline|Arm B: Single-agent MLN0128 30 mg QW|MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
11271453|NCT02724020|BG002|Baseline|Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD|MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA (Median duration of treatment was 9.43 weeks up to end of study).
11271454|NCT02724020|BG003|Baseline|Total|Total of all reporting groups
11271455|NCT02724020|FG000|Participant Flow|Arm A: Single-agent Everolimus 10 mg QD|Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
11271456|NCT02724020|FG001|Participant Flow|Arm B: Single-agent MLN0128 30 mg QW|MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
11271457|NCT02724020|FG002|Participant Flow|Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD|MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
11271458|NCT02724020|OG000|Outcome|Arm A: Single-agent Everolimus 10 mg QD|Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
11271459|NCT02724020|OG001|Outcome|Arm B: Single-agent MLN0128 30 mg QW|MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
11271460|NCT02724020|OG002|Outcome|Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD|MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
11271461|NCT02724020|EG000|Reported Event|Arm A: Single-agent Everolimus 10 mg QD|Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
11271462|NCT02724020|EG001|Reported Event|Arm B: Single-agent MLN0128 30 mg QW|MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
11271463|NCT02724020|EG002|Reported Event|Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD|MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
10970199|NCT00909363|OG000|Outcome|Promacta|"Promacta® is commercially available in 12.5 mg, 25 mg, 50 mg, and 75 mg tablets. For this study, for young children unable to swallow a tablet, eltrombopag powder for oral suspension (Eltrombopag PfOS) will be used. PfOS is only available for investigational use at 20mg. Each sachet contains eltrombopag equivalent to 20mg per gm of powder and is reconstituted to a total of 10 ml so that the concentration is 2 mg/ml.~Promacta (eltrombopag): WAS Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP.~Eltrombopag/promacta: Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP."
11271464|NCT02724033|BG000|Baseline|Group A|"Group A - regional nerve block~regional nerve block: regional nerve block"
11271465|NCT02724033|BG001|Baseline|Group B|"Group B - antiemetic~Antiemetic: Antiemetic"
11271466|NCT02724033|BG002|Baseline|Group C|"Group C - block and antiemetic~regional nerve block: regional nerve block~Antiemetic: Antiemetic"
11271467|NCT02724033|BG003|Baseline|Total|Total of all reporting groups
11271468|NCT02724033|FG000|Participant Flow|Group A|"Group A - regional nerve block~regional nerve block: regional nerve block"
11271469|NCT02724033|FG001|Participant Flow|Group B|"Group B - antiemetic~Antiemetic: Antiemetic"
11271470|NCT02724033|FG002|Participant Flow|Group C|"Group C - block and antiemetic~regional nerve block: regional nerve block~Antiemetic: Antiemetic"
11271471|NCT02724033|OG000|Outcome|Group A|"Group A - regional nerve block~regional nerve block: regional nerve block"
11271472|NCT02724033|OG001|Outcome|Group B|"Group B - antiemetic~Antiemetic: Antiemetic"
11271473|NCT02724033|OG002|Outcome|Group C|"Group C - block and antiemetic~regional nerve block: regional nerve block~Antiemetic: Antiemetic"
11271474|NCT02724033|EG000|Reported Event|Group A|"Group A - regional nerve block~regional nerve block: regional nerve block"
11271475|NCT02724033|EG001|Reported Event|Group B|"Group B - antiemetic~Antiemetic: Antiemetic"
11271476|NCT02724033|EG002|Reported Event|Group C|"Group C - block and antiemetic~regional nerve block: regional nerve block~Antiemetic: Antiemetic"
11271477|NCT02724111|BG000|Baseline|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
11271478|NCT02724111|BG001|Baseline|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
11271479|NCT02724111|BG002|Baseline|Total|Total of all reporting groups
11271480|NCT02724111|FG000|Participant Flow|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (train-of-four [TOF] count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
11271481|NCT02724111|FG001|Participant Flow|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
11271482|NCT02724111|OG000|Outcome|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
11271483|NCT02724111|OG001|Outcome|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
11271484|NCT02724111|EG000|Reported Event|Deep Neuromuscular Blockade|"This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.~sufficient dose of rocuronium"
11271485|NCT02724111|EG001|Reported Event|Restricted Neuromuscular Blockade|"This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.~sugammadex 10 min after position change"
11271486|NCT02724423|BG000|Baseline|NRL-1|Single intranasal doses of NRL-1 (diazepam nasal spray) in epilepsy subjects during the ictal/peri-ictal period and single intranasal doses of NRL-1 (diazepam nasal spray) to the same subjects during the inter-ictal period.
11271487|NCT02724423|FG000|Participant Flow|NRL-1|Single intranasal doses of NRL-1 (diazepam nasal spray) in epilepsy subjects during the ictal/peri-ictal period and single intranasal doses of NRL-1 (diazepam nasal spray) to the same subjects during the inter-ictal period.
11271488|NCT02724423|OG000|Outcome|NRL-1 ICTAL/PERI-ICTAL|NRL-1 ICTAL/PERI-ICTAL: This was a Phase 1, open-label, PK Study of Diazepam After Single Intranasal Doses of NRL-1 Administered to epilepsy Subjects During the Ictal or Peri-ictal Period.
11271489|NCT02724423|OG001|Outcome|NRL-1 INTER-ICTAL|NRL-1 INTER-ICTAL: This was a Phase 1, open-label, PK Study of Diazepam After Single Intranasal Doses of NRL-1 Administered to epilepsy Subjects During the Inter-ictal Period.
11271490|NCT02724423|EG000|Reported Event|NRL-1|"A single intranasal dose of NRL-1 will be administered at either 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight.~NRL-1"
11271491|NCT02724449|BG000|Baseline|Cavilon Advanced Barrier Film|"Cavilon Advanced Barrier Film applied to areas of IAD~Cavilon Advanced Barrier Film: Cavilon Advanced Barrier Fim's application applied twice a week"
11271492|NCT02724449|FG000|Participant Flow|Open-label Study|No competitive products evaluated.
11271493|NCT02724449|OG000|Outcome|Open Label Study|
11271494|NCT02724449|EG000|Reported Event|Open-label Study|Single arm study
11271495|NCT02724462|BG000|Baseline|Experimental|Novel/experimental intervention smartphone smoking cessation app iCanQuit.
11271496|NCT02724462|BG001|Baseline|Control|Standard of care control smoking cessation app QuitGuide from NCI.
11271497|NCT02724462|BG002|Baseline|Total|Total of all reporting groups
11271498|NCT02724462|FG000|Participant Flow|Experimental|Novel/experimental intervention smartphone smoking cessation app iCanQuit.
11271499|NCT02724462|FG001|Participant Flow|Control|Standard of care control smoking cessation app QuitGuide from NCI.
11271500|NCT02724462|OG000|Outcome|Experimental|Novel/experimental intervention smartphone smoking cessation app iCanQuit.
11271501|NCT02724462|OG001|Outcome|Control|Standard of care control smoking cessation app QuitGuide from NCI.
11271502|NCT02724462|EG000|Reported Event|Experimental|Novel/experimental intervention smartphone smoking cessation app iCanQuit.
11271503|NCT02724462|EG001|Reported Event|Control|Standard of care control smoking cessation app QuitGuide from NCI.
11271504|NCT02724592|BG000|Baseline|Intervention|"intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)~self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271505|NCT02724592|BG001|Baseline|Control|"control group, only Fluoride varnish (Duraphat®)~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271506|NCT02724592|BG002|Baseline|Total|Total of all reporting groups
11271507|NCT02724592|FG000|Participant Flow|Intervention|"intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)~self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271508|NCT02724592|FG001|Participant Flow|Control|"control group, only Fluoride varnish (Duraphat®)~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271509|NCT02724592|OG000|Outcome|Intervention|"intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)~self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271510|NCT02724592|OG001|Outcome|Control|"control group, only Fluoride varnish (Duraphat®)~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271511|NCT02724592|EG000|Reported Event|Intervention|"intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)~self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271512|NCT02724592|EG001|Reported Event|Control|"control group, only Fluoride varnish (Duraphat®)~fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions"
11271513|NCT02724644|BG000|Baseline|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
11271514|NCT02724644|BG001|Baseline|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
11271515|NCT02724644|BG002|Baseline|Total|Total of all reporting groups
11271516|NCT02724644|FG000|Participant Flow|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
11271517|NCT02724644|FG001|Participant Flow|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
11271518|NCT02724644|OG000|Outcome|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
11271519|NCT02724644|OG001|Outcome|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
11271520|NCT02724644|EG000|Reported Event|EN3835 0.84 mg|"Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.~Injectable intervention"
11271521|NCT02724644|EG001|Reported Event|Placebo|Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
11271522|NCT02724787|BG000|Baseline|Open Trial|"All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.~Manage Emotions to Reduce Aggression (MERA): MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions."
11271523|NCT02724787|FG000|Participant Flow|Open Trial|"All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.~Manage Emotions to Reduce Aggression (MERA): MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions."
11271524|NCT02724787|OG000|Outcome|Open Trial|"All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.~Manage Emotions to Reduce Aggression (MERA): MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions."
11271525|NCT02724787|EG000|Reported Event|Open Trial|"All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.~Manage Emotions to Reduce Aggression (MERA): MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions."
11271526|NCT02724800|BG000|Baseline|Cognitive Behavioral Therapy for Insomnia (CBTI)|"CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.~CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes."
11271527|NCT02724800|BG001|Baseline|Brief Behavioral Treatment for Insomnia (BBTI)|"BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction.~BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (<20 minutes) telephone sessions were conducted on Weeks 2 and 4."
11271528|NCT02724800|BG002|Baseline|Total|Total of all reporting groups
11271529|NCT02724800|FG000|Participant Flow|Cognitive Behavioral Therapy for Insomnia (CBTI)|"Cognitive Behavioral Therapy for Insomnia (CBTI) consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.~CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes."
11271530|NCT02724800|FG001|Participant Flow|Brief Behavioral Treatment for Insomnia (BBTI)|"Brief Behavioral Treatment for Insomnia (BBTI) consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction.~BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (<20 minutes) telephone sessions were conducted on Weeks 2 and 4."
11271531|NCT02724800|OG000|Outcome|CBTI|"CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.~CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes."
11271532|NCT02724800|OG001|Outcome|BBTI|"BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction.~BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (<20 minutes) telephone sessions were conducted on Weeks 2 and 4."
11271533|NCT02724800|EG000|Reported Event|CBTI|"CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.~CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes."
11271534|NCT02724800|EG001|Reported Event|BBTI|"BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction.~BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (<20 minutes) telephone sessions were conducted on Weeks 2 and 4."
11271535|NCT02724839|BG000|Baseline|Biweekly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the first of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered biweekly (first phase).Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11337606|NCT03588910|EG001|Reported Event|Half the Number of Oxycodone Tablets Typically Prescribed|"Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).~Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)~Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)~Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms."
11337607|NCT03589807|BG000|Baseline|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
11337608|NCT03589807|BG001|Baseline|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
10847350|NCT00282841|OG000|Outcome|Stroke Code Patients - Reference Method|Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
11271536|NCT02724839|BG001|Baseline|Monthly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the second of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered monthly (second phase). Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11271537|NCT02724839|BG002|Baseline|Weekly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the third of three non-concurrent phases of the study which sought to compare the feasibility of the group sessions when offered weekly (third phase). For phases one and two participants will participate in only one phase. Due to recruitment issues in the third phase, researchers obtained IRB approval to allow participants from previous phases to participate and instead evaluated feasibility outcomes. Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11271538|NCT02724839|BG003|Baseline|Total|Total of all reporting groups
11271539|NCT02724839|FG000|Participant Flow|Biweekly Arm|13 parent-child dyads were enrolled in this arm which convened biweekly.
11271540|NCT02724839|FG001|Participant Flow|Monthly Arm|12 parent-child dyads were enrolled in this arm which convened monthly.
11271541|NCT02724839|FG002|Participant Flow|Weekly Arm|8 parent-child dyads were enrolled in this arm which convened weekly.
11271542|NCT02724839|OG000|Outcome|Biweekly Arm|12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
11271543|NCT02724839|OG001|Outcome|Monthly Arm|8 parent-child dyads participated in the monthly arm which convened for 6 sessions.
11271544|NCT02724839|OG002|Outcome|Weekly Arm|6 parent-child dyads participated in the weekly arm which convened for 6 sessions.
11271545|NCT02724839|OG000|Outcome|Biweekly Arm|12 parent-child dyads participated in this arm which convened for 6 sessions.
11271546|NCT02724839|OG001|Outcome|Monthly Arm|8 parent-child dyads participated in this arm which convened for 6 sessions.
11271547|NCT02724839|OG002|Outcome|Weekly Arm|6 parent-child dyads participated in this arm which convened for 6 sessions.
11271548|NCT02724839|OG000|Outcome|Biweekly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the first of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered biweekly (first phase).Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11271549|NCT02724839|OG001|Outcome|Monthly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the second of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered monthly (second phase). Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11271550|NCT02724839|OG002|Outcome|Weekly Arm|The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the third of three non-concurrent phases of the study which sought to compare the feasibility of the group sessions when offered weekly (third phase). For phases one and two participants will participate in only one phase. Due to recruitment issues in the third phase, researchers obtained IRB approval to allow participants from previous phases to participate and instead evaluated feasibility outcomes. Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session.
11271551|NCT02724839|OG002|Outcome|Weekly Arm|Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm.
11271552|NCT02724839|EG000|Reported Event|Biweekly Arm|12 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
11271553|NCT02724839|EG001|Reported Event|Monthly Arm|8 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
11271554|NCT02724839|EG002|Reported Event|Weekly Arm|6 parent-child dyads participated in the biweekly arm which convened for 6 sessions.
11271555|NCT02724956|BG000|Baseline|Ambu AuraGain|"SGAD placement using Ambu AuraGain~Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.~Standard Parker Flex Tip endotracheal tube (ETT) size 6.0, 7.0, and 8.0 mm ETT will be used as per anesthesiologist preference.~Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.~Inflate cuff and remove aScope.~Ambu AuraGain: Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.~Ambu aScope: Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO)."
11337359|NCT03582943|FG000|Participant Flow|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11271556|NCT02724956|BG001|Baseline|Teleflex LMA Protector|"SGAD placement using the Teleflex LMA Protector~Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.~Standard Parker Flex Tip ETT size 6.0 and 7.0 mm. ETT will be used as per anesthesiologist preference.~Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.~Inflate cuff and remove aScope.~Teleflex LMA Protector: Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.~Ambu aScope: Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO)."
11271557|NCT02724956|BG002|Baseline|Total|Total of all reporting groups
11271558|NCT02724956|FG000|Participant Flow|Ambu AuraGain|Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271559|NCT02724956|FG001|Participant Flow|Teleflex LMA Protector|Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271560|NCT02724956|OG000|Outcome|Ambu AuraGain|Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271561|NCT02724956|OG001|Outcome|Teleflex LMA Protector|Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271562|NCT02724956|EG000|Reported Event|Ambu AuraGain|Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271563|NCT02724956|EG001|Reported Event|Teleflex LMA Protector|Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
11271564|NCT02725008|BG000|Baseline|Control|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit~Dexamethasone"
11271565|NCT02725008|BG001|Baseline|Investigational|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit~Dexamethasone~placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone"
11271566|NCT02725008|BG002|Baseline|Total|Total of all reporting groups
11271567|NCT02725008|FG000|Participant Flow|Control|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit~Dexamethasone"
11271568|NCT02725008|FG001|Participant Flow|Investigational|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit~Dexamethasone~placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone"
11271569|NCT02725008|OG000|Outcome|Control|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit~Dexamethasone"
10847351|NCT00282841|OG001|Outcome|Stroke Code Patients - Transcranial Ultrasound|All acute stroke patients who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA) did receive a contrast-enhanced transcranial ultrasound study as well.
11271570|NCT02725008|OG001|Outcome|Investigational|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit~Dexamethasone~placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone"
11271571|NCT02725008|EG000|Reported Event|Control|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit~Dexamethasone"
11271572|NCT02725008|EG001|Reported Event|Investigational|"Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit~Dexamethasone~placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone"
10847352|NCT00282841|EG000|Reported Event|Stroke Code Patients|Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
11271573|NCT02725268|BG000|Baseline|Paclitaxel 80 mg/m^2|Paclitaxel 80 milligrams per square meter (mg/m^2), IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 13.00 weeks).
11271574|NCT02725268|BG001|Baseline|Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg|Paclitaxel 80 mg/m^2, IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle along with sapanisertib 4 milligrams (mg), capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 20.14 and 18.50 weeks).
11271575|NCT02725268|BG002|Baseline|Sapanisertib 30 mg|Sapanisertib 30 mg, capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 6.14 weeks).
11271576|NCT02725268|BG003|Baseline|Sapanisertib 4 mg + MLN1117 200 mg|Sapanisertib 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 7.43 weeks).
11271577|NCT02725268|BG004|Baseline|Total|Total of all reporting groups
11271578|NCT02725268|FG000|Participant Flow|Paclitaxel 80 mg/m^2|Paclitaxel 80 milligrams per square meter (mg/m^2), IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 13.00 weeks).
11271579|NCT02725268|FG001|Participant Flow|Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg|Paclitaxel 80 mg/m^2, IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle along with sapanisertib 4 milligrams (mg), capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 20.14 and 18.50 weeks).
11271580|NCT02725268|FG002|Participant Flow|Sapanisertib 30 mg|Sapanisertib 30 mg, capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 6.14 weeks).
11271581|NCT02725268|FG003|Participant Flow|Sapanisertib 4 mg + MLN1117 200 mg|Sapanisertib 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 7.43 weeks).
11271582|NCT02725268|OG000|Outcome|Paclitaxel 80 mg/m^2|Paclitaxel 80 milligrams per square meter (mg/m^2), IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 13.00 weeks).
11271583|NCT02725268|OG001|Outcome|Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg|Paclitaxel 80 mg/m^2, IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle along with sapanisertib 4 milligrams (mg), capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 20.14 and 18.50 weeks).
11271584|NCT02725268|OG002|Outcome|Sapanisertib 30 mg|Sapanisertib 30 mg, capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 6.14 weeks).
11271585|NCT02725268|OG003|Outcome|Sapanisertib 4 mg + MLN1117 200 mg|Sapanisertib 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 7.43 weeks).
11271586|NCT02725268|EG000|Reported Event|Paclitaxel 80 mg/m^2|Paclitaxel 80 milligrams per square meter (mg/m^2), IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 13.00 weeks).
11271587|NCT02725268|EG001|Reported Event|Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg|Paclitaxel 80 mg/m^2, IV, injection, weekly on Days 1, 8, and 15 of a 28-day cycle along with sapanisertib 4 milligrams (mg), capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 20.14 and 18.50 weeks).
11271588|NCT02725268|EG002|Reported Event|Sapanisertib 30 mg|Sapanisertib 30 mg, capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 6.14 weeks).
11271589|NCT02725268|EG003|Reported Event|Sapanisertib 4 mg + MLN1117 200 mg|Sapanisertib 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was 7.43 weeks).
11271590|NCT02725411|BG000|Baseline|Tanezumab 5 mg|Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271591|NCT02725411|BG001|Baseline|Tanezumab 10 mg|Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271592|NCT02725411|BG002|Baseline|Celecoxib|Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271593|NCT02725411|BG003|Baseline|Total|Total of all reporting groups
11271594|NCT02725411|FG000|Participant Flow|Tanezumab 5 mg|Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271595|NCT02725411|FG001|Participant Flow|Tanezumab 10 mg|Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271596|NCT02725411|FG002|Participant Flow|Celecoxib|Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271597|NCT02725411|OG000|Outcome|Tanezumab 5 mg|Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11337609|NCT03589807|BG002|Baseline|"2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
11271598|NCT02725411|OG001|Outcome|Tanezumab 10 mg|Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271599|NCT02725411|OG002|Outcome|Celecoxib|Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271600|NCT02725411|EG000|Reported Event|Tanezumab 5 mg|Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271601|NCT02725411|EG001|Reported Event|Tanezumab 10 mg|Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271602|NCT02725411|EG002|Reported Event|Celecoxib|Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
11271603|NCT02725476|BG000|Baseline|XmAb5871 5 mg/kg|5 mg/kg weight-based dosing group
11271604|NCT02725476|BG001|Baseline|XmAb5871 Fixed Dose|90 mg or 180 mg fixed dose group
11271605|NCT02725476|BG002|Baseline|Total|Total of all reporting groups
11271606|NCT02725476|FG000|Participant Flow|XmAb5871 5 mg/kg|5 mg/kg weight-based dosing group
11271607|NCT02725476|FG001|Participant Flow|XmAb5871 Fixed Dose|90 mg or 180 mg fixed dose group
11271608|NCT02725476|OG000|Outcome|XmAb5871 5 mg/kg|5 mg/kg weight-based dosing group
11271609|NCT02725476|OG001|Outcome|XmAb5871 Fixed Dose|90 mg or 180 mg fixed dose group
11271610|NCT02725476|EG000|Reported Event|XmAb5871 5 mg/kg|5 mg/kg weight-based dosing group
11271611|NCT02725476|EG001|Reported Event|XmAb5871 Fixed Dose|90 mg or 180 mg fixed dose group
11271612|NCT02725515|BG000|Baseline|XmAb5871|XmAb5871 administered by IV infusion for up to a total of 16 infusions
11271613|NCT02725515|BG001|Baseline|Placebo|Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
11271614|NCT02725515|BG002|Baseline|Total|Total of all reporting groups
11271615|NCT02725515|FG000|Participant Flow|XmAb5871|XmAb5871 administered by IV infusion for up to a total of 16 infusions
11271616|NCT02725515|FG001|Participant Flow|Placebo|Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
11271617|NCT02725515|OG000|Outcome|XmAb5871|XmAb5871 administered by IV infusion for up to a total of 16 infusions
11271618|NCT02725515|OG001|Outcome|Placebo|Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
11271619|NCT02725515|EG000|Reported Event|XmAb5871|XmAb5871 administered by IV infusion for up to a total of 16 infusions
11271620|NCT02725515|EG001|Reported Event|Placebo|Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
11271621|NCT02725645|BG000|Baseline|Healthy School Children|Participants had to stand with different backpack loading conditions.
11271622|NCT02725645|FG000|Participant Flow|Healthy School Children|Participants had to stand, using backpacks with different load conditions, while being monitored with emg.
11271623|NCT02725645|OG000|Outcome|Healthy School Children|14 elementary school children participated in the study, 9 female and 5 male.
11271624|NCT02725645|EG000|Reported Event|Healthy School Children|Participants had to stand with different backpack loading conditions
11271625|NCT02725710|BG000|Baseline|Group 1: Placebo|"Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.~Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure"
11271626|NCT02725710|BG001|Baseline|Group 2: Gabapentin|"Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.~Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure"
11271627|NCT02725710|BG002|Baseline|Total|Total of all reporting groups
11271628|NCT02725710|FG000|Participant Flow|Group 1: Placebo|"Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.~Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure"
11271629|NCT02725710|FG001|Participant Flow|Group 2: Gabapentin|"Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.~Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure"
11271630|NCT02725710|OG000|Outcome|Group 1: Placebo|"Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.~Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure"
11271631|NCT02725710|OG001|Outcome|Group 2: Gabapentin|"Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.~Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure"
11271632|NCT02725710|EG000|Reported Event|Group 1: Placebo|"Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.~Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure"
11271633|NCT02725710|EG001|Reported Event|Group 2: Gabapentin|"Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.~Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure"
11271634|NCT02725788|BG000|Baseline|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
11271635|NCT02725788|BG001|Baseline|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
11271636|NCT02725788|BG002|Baseline|Total|Total of all reporting groups
11271637|NCT02725788|FG000|Participant Flow|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
11271638|NCT02725788|FG001|Participant Flow|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
11271639|NCT02725788|OG000|Outcome|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
11271640|NCT02725788|OG001|Outcome|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
11271641|NCT02725788|EG000|Reported Event|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
11271642|NCT02725788|EG001|Reported Event|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
11271643|NCT02725801|BG000|Baseline|One-port|"intervention is placement of one-port tissue expander at time of reconstruction~Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271644|NCT02725801|BG001|Baseline|Two-port|"intervention is placement of two-port tissue expander at time of reconstruction~AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271645|NCT02725801|BG002|Baseline|Total|Total of all reporting groups
11271646|NCT02725801|FG000|Participant Flow|One-port|"intervention is placement of one-port tissue expander at time of reconstruction~Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271647|NCT02725801|FG001|Participant Flow|Two-port|"intervention is placement of two-port tissue expander at time of reconstruction~AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271648|NCT02725801|OG000|Outcome|One-port|"intervention is placement of one-port tissue expander at time of reconstruction~Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271649|NCT02725801|OG001|Outcome|Two-port|"intervention is placement of two-port tissue expander at time of reconstruction~AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271650|NCT02725801|EG000|Reported Event|One-port|"intervention is placement of one-port tissue expander at time of reconstruction~Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271651|NCT02725801|EG001|Reported Event|Two-port|"intervention is placement of two-port tissue expander at time of reconstruction~AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction"
11271652|NCT02725866|BG000|Baseline|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11271653|NCT02725866|FG000|Participant Flow|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11271654|NCT02725866|OG000|Outcome|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11271655|NCT02725866|EG000|Reported Event|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
11271656|NCT02726022|BG000|Baseline|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
11271657|NCT02726022|FG000|Participant Flow|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
11271658|NCT02726022|OG000|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
11271659|NCT02726022|EG000|Reported Event|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
11271660|NCT02726074|BG000|Baseline|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.
11271661|NCT02726074|FG000|Participant Flow|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 milligrams per day (mg/day) and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.
11337610|NCT03589807|BG003|Baseline|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
11271662|NCT02726074|OG000|Outcome|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.
11271663|NCT02726074|EG000|Reported Event|Perampanel 12 mg|During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.
11271664|NCT02726113|BG000|Baseline|Intervention|vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
11271665|NCT02726113|BG001|Baseline|Placebo|softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
11271666|NCT02726113|BG002|Baseline|Total|Total of all reporting groups
11271667|NCT02726113|FG000|Participant Flow|Intervention|vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
11271668|NCT02726113|FG001|Participant Flow|Placebo|softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
11271669|NCT02726113|OG000|Outcome|Intervention|vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
11271670|NCT02726113|OG001|Outcome|Control|Placebo softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
11271671|NCT02726113|OG000|Outcome|All Study Participants|All study participants undergoing genomic analysis of prostrate tissue
11271672|NCT02726113|EG000|Reported Event|Intervention|vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
11271673|NCT02726113|EG001|Reported Event|Placebo|softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
11271674|NCT02726178|BG000|Baseline|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271675|NCT02726178|BG001|Baseline|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271676|NCT02726178|BG002|Baseline|Total|Total of all reporting groups
11271677|NCT02726178|FG000|Participant Flow|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271678|NCT02726178|FG001|Participant Flow|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271679|NCT02726178|OG000|Outcome|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271680|NCT02726178|OG001|Outcome|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271681|NCT02726178|OG000|Outcome|Advil® Pediatric Drops for Infants|"Two annotated polysomnographies were performed for all patients:~The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.~The second was conducted 18 to 24 hours after immunization.~We compared the data of polysomnographies after to those before immunization.~Polysomnography : an AURA PSG GRASS ambulatory and wireless system."
11271682|NCT02726178|OG001|Outcome|Control|"Two annotated polysomnographies were performed for all patients:~The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.~The second was conducted 18 to 24 hours after immunization.~We compared the data of polysomnographies after to those before immunization.~Polysomnography : an AURA PSG GRASS ambulatory and wireless system."
11271683|NCT02726178|EG000|Reported Event|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271684|NCT02726178|EG001|Reported Event|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
11271685|NCT02726451|BG000|Baseline|Basic Skin Care|"Subjects use a basic skin care regimen.~Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271686|NCT02726451|BG001|Baseline|Active Skin Care|"Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.~Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271687|NCT02726451|BG002|Baseline|Total|Total of all reporting groups
11271688|NCT02726451|FG000|Participant Flow|Basic Skin Care|"Subjects use a basic skin care regimen.~Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271689|NCT02726451|FG001|Participant Flow|Active Skin Care|"Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.~Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271690|NCT02726451|OG000|Outcome|Basic Skin Care|"Subjects use a basic skin care regimen.~Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271691|NCT02726451|OG001|Outcome|Active Skin Care|"Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.~Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271692|NCT02726451|EG000|Reported Event|Basic Skin Care|"Subjects use a basic skin care regimen.~Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271693|NCT02726451|EG001|Reported Event|Active Skin Care|"Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.~Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)"
11271694|NCT02726542|BG000|Baseline|Growth Hormone|"Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.~somatropin: Norditropin (growth hormone) given by injection using a pen-device"
11271695|NCT02726542|BG001|Baseline|No Treatment|(no study treatment - observation only)
10847353|NCT00282919|BG000|Baseline|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
11271696|NCT02726542|BG002|Baseline|Total|Total of all reporting groups
11271697|NCT02726542|FG000|Participant Flow|Growth Hormone|"Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.~somatropin: Norditropin (growth hormone) given by injection using a pen-device"
11271698|NCT02726542|FG001|Participant Flow|No Treatment|(no study treatment - observation only)
11271699|NCT02726542|OG000|Outcome|Growth Hormone|"Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.~somatropin: Norditropin (growth hormone) given by injection using a pen-device"
11271700|NCT02726542|OG001|Outcome|No Treatment|(no study treatment - observation only)
11271701|NCT02726542|EG000|Reported Event|Growth Hormone|"Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.~somatropin: Norditropin (growth hormone) given by injection using a pen-device"
11271702|NCT02726542|EG001|Reported Event|No Treatment|(no study treatment - observation only)
11271703|NCT02726620|BG000|Baseline|Usual Care Group|The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
11271704|NCT02726620|BG001|Baseline|Hypotension Decision Support|"The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.~Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.~All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia."
11271705|NCT02726620|BG002|Baseline|Total|Total of all reporting groups
11271706|NCT02726620|FG000|Participant Flow|Usual Care Group|The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
11337611|NCT03589807|BG004|Baseline|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
11337612|NCT03589807|BG005|Baseline|"2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
11337613|NCT03589807|BG006|Baseline|Total|Total of all reporting groups
11271707|NCT02726620|FG001|Participant Flow|Hypotension Decision Support|"The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.~Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.~All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia."
11271708|NCT02726620|OG000|Outcome|Usual Care Group|The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
11271709|NCT02726620|OG001|Outcome|Hypotension Decision Support|"The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.~Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.~All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia."
11271710|NCT02726620|EG000|Reported Event|Usual Care Group|The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
11271711|NCT02726620|EG001|Reported Event|Hypotension Decision Support|"The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.~Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.~All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia."
11271712|NCT02726789|BG000|Baseline|Experimental|"Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.~REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex~pegylated interferon: immunotherapy~Participants receiving entecavir at the start of therapy continue to receive entecavir during experimental therapy."
11271713|NCT02726789|FG000|Participant Flow|Experimental|Patients to receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.
11271714|NCT02726789|OG000|Outcome|Experimental|"Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.~REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex~pegylated interferon: immunotherapy~Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy."
11271715|NCT02726789|OG000|Outcome|Experimental|"Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.~REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex~pegylated interferon: immunotherapy~Partiipants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy."
11271716|NCT02726789|EG000|Reported Event|Experimental|"Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.~REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex~pegylated interferon: immunotherapy~Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy."
11286821|NCT02894502|BG001|Baseline|Motivational Interviewing to Patients and Caregivers|"In this arm the interventions will be delivered both to patients and caregivers~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11286822|NCT02894502|BG002|Baseline|Control Group|This Group will receive the usual care
11286823|NCT02894502|BG003|Baseline|Total|Total of all reporting groups
11337634|NCT03589807|EG005|Reported Event|"2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
10847354|NCT00282919|FG000|Participant Flow|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
11271717|NCT02726945|BG000|Baseline|Low Dose SVF|This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
11271718|NCT02726945|BG001|Baseline|High Dose SVF|This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
11271719|NCT02726945|BG002|Baseline|Placebo|This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
11271720|NCT02726945|BG003|Baseline|Total|Total of all reporting groups
11271721|NCT02726945|FG000|Participant Flow|Low Dose SVF|This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
11271722|NCT02726945|FG001|Participant Flow|High Dose SVF|This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
11271723|NCT02726945|FG002|Participant Flow|Placebo|This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
11271724|NCT02726945|OG000|Outcome|Low Dose SVF|This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
11271725|NCT02726945|OG001|Outcome|High Dose SVF|This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
11271726|NCT02726945|OG002|Outcome|Placebo|This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
11271727|NCT02726945|EG000|Reported Event|Low Dose SVF|This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
11271728|NCT02726945|EG001|Reported Event|High Dose SVF|This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
10847355|NCT00282919|OG000|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
10847356|NCT00282919|EG000|Reported Event|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
11271729|NCT02726945|EG002|Reported Event|Placebo|This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
10847357|NCT00282971|BG000|Baseline|Inhaled Insulin|Inhaled insulin plus oral therapy
11271730|NCT02726971|BG000|Baseline|2mg Estradiol Therapy(Low Dose)|"mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3~BMI=body mass index"
11271731|NCT02726971|BG001|Baseline|6mg Estradiol Therapy(High Dose)|"mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1~BMI=body mass index"
11271732|NCT02726971|BG002|Baseline|Total|Total of all reporting groups
11271733|NCT02726971|FG000|Participant Flow|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271734|NCT02726971|FG001|Participant Flow|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271735|NCT02726971|OG000|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271736|NCT02726971|OG001|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271737|NCT02726971|EG000|Reported Event|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271738|NCT02726971|EG001|Reported Event|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
11271739|NCT02727192|BG000|Baseline|PAP-therapy (CPAP or ASV)|PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).
11271740|NCT02727192|BG001|Baseline|Control Group|No sleep apnea treatment (usual care)
11271741|NCT02727192|BG002|Baseline|Total|Total of all reporting groups
11271742|NCT02727192|FG000|Participant Flow|CPAP-therapy|CPAP-therapy (Continous Positive Airway Pressure)
11271743|NCT02727192|FG001|Participant Flow|Control Group|No sleep apnea treatment (usual care)
11271744|NCT02727192|FG002|Participant Flow|ASV-therapy|ASV-therapy (Adaptive Servo-Ventilation)
11271745|NCT02727192|OG000|Outcome|PAP-therapy (CPAP or ASV)|PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).
11271746|NCT02727192|OG001|Outcome|Control Group|No sleep apnea treatment (usual care)
11271747|NCT02727192|EG000|Reported Event|CPAP-therapy|Positive airway pressure therapy (CPAP)
11271748|NCT02727192|EG001|Reported Event|Control Group|No sleep apnea treatment
11271749|NCT02727192|EG002|Reported Event|ASV Therapy|Adaptive Servo Ventilation (ASV)
11271750|NCT02727322|BG000|Baseline|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use."
11271751|NCT02727322|BG001|Baseline|Placebo|"Receives matching placebo~Placebo: Patients will receive identical appearing placebo once daily during catheter use."
11271752|NCT02727322|BG002|Baseline|Total|Total of all reporting groups
11271753|NCT02727322|FG000|Participant Flow|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use."
11271754|NCT02727322|FG001|Participant Flow|Placebo|"Receives matching placebo~Placebo: Patients will receive identical appearing placebo once daily during catheter use."
11271755|NCT02727322|OG000|Outcome|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheterization."
11271756|NCT02727322|OG001|Outcome|Placebo|"Receives matching placebo~Placebo: Patients will receive identical appearing placebo daily during catheterization."
11271757|NCT02727322|OG000|Outcome|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use."
11271758|NCT02727322|OG001|Outcome|Placebo|"Receives matching placebo~Placebo: Patients will receive identical appearing placebo once daily during catheter use."
11271759|NCT02727322|OG000|Outcome|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical."
11271760|NCT02727322|OG001|Outcome|Placebo|"Receives matching placebo~Placebo: Placebo"
11271761|NCT02727322|EG000|Reported Event|Nitrofurantoin|"Receives once daily nitrofurantoin 100mg~Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use."
11271762|NCT02727322|EG001|Reported Event|Placebo|"Receives matching placebo~Placebo: Patients will receive identical appearing placebo once daily during catheter use."
11271763|NCT02727660|BG000|Baseline|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
11271764|NCT02727660|BG001|Baseline|BFF MDI 160/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
11271765|NCT02727660|BG002|Baseline|FF MDI 9.6 ug|Formoterol Fumarate Metered dose inhalation 9.6 ug
11271766|NCT02727660|BG003|Baseline|Total|Total of all reporting groups
11271767|NCT02727660|FG000|Participant Flow|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
11271768|NCT02727660|FG001|Participant Flow|BFF MDI 160/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
11271769|NCT02727660|FG002|Participant Flow|FF MDI 9.6 ug|Formoterol Fumarate Metered dose inhalation 9.6 ug
11271770|NCT02727660|OG000|Outcome|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
11271771|NCT02727660|OG001|Outcome|BFF MDI 160/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
11271772|NCT02727660|OG002|Outcome|FF MDI 9.6 ug|Formoterol Fumarate Metered dose inhalation 9.6 ug
11271773|NCT02727660|EG000|Reported Event|BFF MDI 320/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
11271774|NCT02727660|EG001|Reported Event|BFF MDI 160/9.6 ug|Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
11271775|NCT02727660|EG002|Reported Event|FF MDI 9.6 ug|Formoterol Fumarate Metered dose inhalation 9.6 ug
11271776|NCT02727751|BG000|Baseline|50mg BID|Tenapanor, 50 mg BID (100 mg total)
11271777|NCT02727751|FG000|Participant Flow|50mg BID|Tenapanor, 50 mg BID (100 mg total)
11271778|NCT02727751|OG000|Outcome|50mg BID|Tenapanor, 50 mg BID (100 mg total)
11271779|NCT02727751|EG000|Reported Event|50mg BID|Tenapanor, 50 mg BID (100 mg total)
11271780|NCT02727777|BG000|Baseline|Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr|Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b
11271781|NCT02727777|BG001|Baseline|Indolent NHL:FL grade1-3a,SLL,MZL|Indolent NHL:FL grade1-3a,SLL,MZL
11271782|NCT02727777|BG002|Baseline|Hodgkin Lymphoma|Hodgkin lymphoma
11271783|NCT02727777|BG003|Baseline|Total|Total of all reporting groups
11271784|NCT02727777|FG000|Participant Flow|Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr|Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b
11271785|NCT02727777|FG001|Participant Flow|Indolent NHL:FL grade1-3a,SLL,MZL|Indolent NHL:FL grade1-3a,SLL,MZL
11271786|NCT02727777|FG002|Participant Flow|Hodgkin Lymphoma|Hodgkin lymphoma
11271787|NCT02727777|OG000|Outcome|Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr|Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b
11271788|NCT02727777|OG001|Outcome|Indolent NHL:FL grade1-3a,SLL,MZL|Indolent NHL:FL grade1-3a,SLL,MZL
11271789|NCT02727777|OG002|Outcome|Hodgkin Lymphoma|Hodgkin lymphoma
11271790|NCT02727777|EG000|Reported Event|Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr|Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b
11271791|NCT02727777|EG001|Reported Event|Indolent NHL:FL grade1-3a,SLL,MZL|Indolent NHL:FL grade1-3a,SLL,MZL
11271792|NCT02727777|EG002|Reported Event|Hodgkin Lymphoma|Hodgkin lymphoma
11271793|NCT02727816|BG000|Baseline|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
11271794|NCT02727816|FG000|Participant Flow|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
11271795|NCT02727816|OG000|Outcome|Filcon IV I (BC 8.6) - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.6): control lens"
11271796|NCT02727816|OG001|Outcome|Ocufilcon D - Pair One|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
11271797|NCT02727816|OG000|Outcome|Filcon IV I (BC 8.7) - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
11271798|NCT02727816|OG001|Outcome|Ocufilcon D - Pair Two|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
11271799|NCT02727816|OG000|Outcome|Filcon IV I (BC 8.6) - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
11271800|NCT02727816|OG001|Outcome|Ocufilcon D - Pair Three|"Participants were randomized to a test and control lens for each pair in a contralateral design.~ocufilcon D: test lens"
11271801|NCT02727816|OG000|Outcome|Filcon IV I (BC 8.7) - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~filcon IV I (BC 8.7): control lens"
11271802|NCT02727816|OG001|Outcome|Somofilcon A - Pair Four|"Participants were randomized to a test and control lens for each pair in a contralateral design.~somofilcon A: test lens"
11271803|NCT02727816|OG000|Outcome|Prefer Filcon IV I (BC 8.6) - Pair One|
11271804|NCT02727816|OG001|Outcome|Prefer Ocufilcon D - Pair One|
11271805|NCT02727816|OG002|Outcome|No Preference|
11271806|NCT02727816|OG000|Outcome|Prefer Filcon IV I (BC 8.7) - Pair Two|
11271807|NCT02727816|OG001|Outcome|Prefer Ocufilcon D - Pair Two|
11271808|NCT02727816|OG000|Outcome|Prefer Methafilcon A (BC 8.6) - Pair Three|
11271809|NCT02727816|OG001|Outcome|Prefer Ocufilcon D - Pair Three|
11271810|NCT02727816|OG000|Outcome|Prefer Methafilcon A (BC 8.7) - Pair Four|
11271811|NCT02727816|OG001|Outcome|Prefer Somofilcon A - Pair Four|
11271812|NCT02727816|EG000|Reported Event|Overall Participants|Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
11271813|NCT02727842|BG000|Baseline|Treatment Group|"All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod~CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor~Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software"
11271814|NCT02727842|FG000|Participant Flow|Treatment Group|"All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod~CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor~Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software"
11271815|NCT02727842|OG000|Outcome|All Subjects|All study participants were analyzed in the treatment group.
11271816|NCT02727842|EG000|Reported Event|Treatment Group|There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero.
11271817|NCT02727894|BG000|Baseline|Screening|Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after FOBT).
11271818|NCT02727894|BG001|Baseline|Others|Patients with colorectal cancer diagnosed by other diagnostic procedures (diagnostic colonoscopy, CT, magnetic resonance, ultrasonography, urgent surgery, etc.)
11271819|NCT02727894|BG002|Baseline|Total|Total of all reporting groups
11271820|NCT02727894|FG000|Participant Flow|Screening Group|CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test (iFOBT) in patients without symptoms invited to examination according to the national screening programme policy
11271821|NCT02727894|FG001|Participant Flow|Non-screening Group|Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.
11271822|NCT02727894|OG000|Outcome|Screening Group|Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).
11271823|NCT02727894|OG001|Outcome|Non-Screening Group|Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
11271824|NCT02727894|OG000|Outcome|Screening Group|Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).
11271825|NCT02727894|OG001|Outcome|Non-screening Group|Symptomatic CRC (non-screening group) was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
11271826|NCT02727894|OG001|Outcome|Non-screening Group|Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
11271827|NCT02727894|EG000|Reported Event|Screening Group|Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after FOBT).
11271828|NCT02727894|EG001|Reported Event|Non-screening Group|Symptomatic CRC was defined as carcinoma detected by CT, MR or sonography and then verified by colonoscopy.
11271829|NCT02728089|BG000|Baseline|MK-7625A|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min.
11271830|NCT02728089|FG000|Participant Flow|MK-7625A|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min.
11271831|NCT02728089|OG000|Outcome|MK-7625A|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min.
11271832|NCT02728089|EG000|Reported Event|MK-7625A|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min.
11271833|NCT02728102|BG000|Baseline|Lenalidomide, Vaccine, and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.~Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~Myeloma vaccine: The target dose is 3 x 10^6 fusion cells per vaccine. A minimum of 3 x 10^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.~GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle."
11337635|NCT03589885|BG000|Baseline|Secukinumab 2 mL Auto-injector|Secukinumab 300 mg provided in 2 mL auto-injector form
11337636|NCT03589885|BG001|Baseline|Secukinumab 1 mL Prefilled Syringe|Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
11337637|NCT03589885|BG002|Baseline|Placebo|Placebo to Secukinumab
11337638|NCT03589885|BG003|Baseline|Total|Total of all reporting groups
11271834|NCT02728102|BG001|Baseline|Lenalidomide and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle."
11271835|NCT02728102|BG002|Baseline|Maintenance Lenalidomide|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy."
11271836|NCT02728102|BG003|Baseline|Total|Total of all reporting groups
11271837|NCT02728102|FG000|Participant Flow|Lenalidomide, Vaccine, and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.~Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~Myeloma vaccine: The target dose is 3 x 10^6 fusion cells per vaccine. A minimum of 3 x 10^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.~GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle."
11271838|NCT02728102|FG001|Participant Flow|Lenalidomide and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle."
11271839|NCT02728102|FG002|Participant Flow|Maintenance Lenalidomide|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy."
11286824|NCT02894502|FG000|Participant Flow|Motivational Interviewing Only for Patients|"In this arm the interventions will be delivered only to patients~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11337639|NCT03589885|FG000|Participant Flow|Secukinumab 300 mg (2 mL AI)|Secukinumab 300 mg provided in 2 mL auto-injector form
11271840|NCT02728102|OG000|Outcome|Lenalidomide, Vaccine, and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.~Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~Myeloma vaccine: The target dose is 3 x 10^6 fusion cells per vaccine. A minimum of 3 x 10^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.~GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle."
11271841|NCT02728102|OG001|Outcome|Lenalidomide With or Without GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with or without GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle."
11271842|NCT02728102|EG000|Reported Event|Lenalidomide, Vaccine, and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.~Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~Myeloma vaccine: The target dose is 3 x 10^6 fusion cells per vaccine. A minimum of 3 x 10^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.~GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle."
11271843|NCT02728102|EG001|Reported Event|Lenalidomide and GM-CSF|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.~GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle."
11271844|NCT02728102|EG002|Reported Event|Maintenance Lenalidomide|"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.~Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).~Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.~Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.~Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy."
11271845|NCT02728206|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
11271846|NCT02728206|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
11271847|NCT02728206|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
11271848|NCT02728206|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
11271849|NCT02728830|BG000|Baseline|Pembrolizumab|"Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.~If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.~If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.~Pembrolizumab: Pembrolizumab 200mg IV"
11271850|NCT02728830|FG000|Participant Flow|Pembrolizumab|"Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.~If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.~If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.~Pembrolizumab: Pembrolizumab 200mg IV"
11271851|NCT02728830|OG000|Outcome|Pembrolizumab|"Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.~If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.~If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.~Pembrolizumab: Pembrolizumab 200mg IV"
11271852|NCT02728830|EG000|Reported Event|Pembrolizumab|"Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.~If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.~If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.~Pembrolizumab: Pembrolizumab 200mg IV"
11271853|NCT02728895|BG000|Baseline|Cohort 1: Vedolizumab 75 mg|Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271854|NCT02728895|BG001|Baseline|Cohort 2: Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271855|NCT02728895|BG002|Baseline|Total|Total of all reporting groups
11271856|NCT02728895|FG000|Participant Flow|Cohort 1: Vedolizumab 75 mg|Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271857|NCT02728895|FG001|Participant Flow|Cohort 2: Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271858|NCT02728895|OG000|Outcome|Cohort 1: Vedolizumab 75 mg|Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271859|NCT02728895|OG001|Outcome|Cohort 2: Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271860|NCT02728895|EG000|Reported Event|Cohort 1: Vedolizumab 75 mg|Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271861|NCT02728895|EG001|Reported Event|Cohort 2: Vedolizumab 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
11271862|NCT02729025|BG000|Baseline|Placebo|Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271863|NCT02729025|BG001|Baseline|Evolocumab 420 mg QM|Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271864|NCT02729025|BG002|Baseline|Total|Total of all reporting groups
11271865|NCT02729025|FG000|Participant Flow|Placebo|Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271866|NCT02729025|FG001|Participant Flow|Evolocumab 420 mg QM|Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271867|NCT02729025|OG000|Outcome|Placebo|Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271868|NCT02729025|OG001|Outcome|Evolocumab 420 mg QM|Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271869|NCT02729025|EG000|Reported Event|Placebo QM|Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271870|NCT02729025|EG001|Reported Event|Evolocumab 420 mg QM|Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
11271871|NCT02729038|BG000|Baseline|Normal, Part 1|The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated Clcr >= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271872|NCT02729038|BG001|Baseline|Moderate, Part 1|The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271873|NCT02729038|BG002|Baseline|Severe/ESRD Not on Hemodialysis, Part 1|The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271874|NCT02729038|BG003|Baseline|ESRD on Hemodialysis, Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
11271875|NCT02729038|BG004|Baseline|Total|Total of all reporting groups
11271876|NCT02729038|FG000|Participant Flow|Normal, Part 1|The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated creatinine clearance (Clcr) >= 90 milliliter per minute), in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271877|NCT02729038|FG001|Participant Flow|Moderate|The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271878|NCT02729038|FG002|Participant Flow|Severe/ESRD Not on Hemodialysis, Part 1|The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271879|NCT02729038|FG003|Participant Flow|ESRD on Hemodialysis, Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
11271880|NCT02729038|OG000|Outcome|Normal, Part 1|The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated Clcr >= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271881|NCT02729038|OG001|Outcome|Moderate, Part 1|The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271882|NCT02729038|OG002|Outcome|Severe/ESRD Not on Hemodialysis, Part 1|The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271883|NCT02729038|OG001|Outcome|ESRD on Hemodialysis (Before Hemodialysis), Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (treatment period 1).
11271884|NCT02729038|OG002|Outcome|ESRD on Hemodialysis (After Hemodialysis), Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
11271885|NCT02729038|OG000|Outcome|ESRD on Hemodialysis (Before Hemodialysis), Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (treatment period 1).
11271886|NCT02729038|OG001|Outcome|ESRD on Hemodialysis (After Hemodialysis), Part 2|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
10847358|NCT00282971|BG001|Baseline|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
10847359|NCT00282971|BG002|Baseline|Total|Total of all reporting groups
10847360|NCT00282971|FG000|Participant Flow|Inhaled Insulin|Inhaled insulin plus oral therapy
11271887|NCT02729038|OG000|Outcome|ESRD on Hemodialysis|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
11271888|NCT02729038|OG000|Outcome|Moderate, Part 1|The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271889|NCT02729038|OG001|Outcome|Severe/ESRD Not on Hemodialysis, Part 1|The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271890|NCT02729038|EG000|Reported Event|Normal, Part 1|The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated Clcr >= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271891|NCT02729038|EG001|Reported Event|Moderate, Part 1|The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271892|NCT02729038|EG002|Reported Event|Severe/ESRD Not on Hemodialysis, Part 1|The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
11271893|NCT02729038|EG003|Reported Event|ESRD on Hemodialysis (Before Hemodialysis)|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (treatment period 1).
11271894|NCT02729038|EG004|Reported Event|ESRD on Hemodialysis (After Hemodialysis)|The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
11271895|NCT02729051|BG000|Baseline|FF/UMEC/VI 100/62.5/25|Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271896|NCT02729051|BG001|Baseline|FF/VI 100/25 + UMEC 62.5|Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271897|NCT02729051|BG002|Baseline|Total|Total of all reporting groups
11271898|NCT02729051|FG000|Participant Flow|FF/UMEC/VI 100/62.5/25|Participants received FF/UMEC/VI, 100 micrograms (mcg)/62.5 mcg/25 mcg via ELLIPTA dry powder inhaler (DPI) once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271899|NCT02729051|FG001|Participant Flow|FF/VI 100/25 + UMEC 62.5|Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271900|NCT02729051|OG000|Outcome|FF/UMEC/VI 100/62.5/25|Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271901|NCT02729051|OG001|Outcome|FF/VI 100/25 + UMEC 62.5|Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271902|NCT02729051|EG000|Reported Event|FF/UMEC/VI 100/62.5/25|Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271903|NCT02729051|EG001|Reported Event|FF/VI 100/25 + UMEC 62.5|Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
11271904|NCT02729194|BG000|Baseline|Pazopanib|Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
11271905|NCT02729194|FG000|Participant Flow|Pazopanib|Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
10847361|NCT00282971|FG001|Participant Flow|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
11271906|NCT02729194|OG000|Outcome|Pazopanib|Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
11271907|NCT02729194|EG000|Reported Event|Pazopanib|Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
11271908|NCT02729545|BG000|Baseline|Tung's Acupuncture|The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
11271909|NCT02729545|BG001|Baseline|CPA/EE|Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
11271910|NCT02729545|BG002|Baseline|Total|Total of all reporting groups
11271911|NCT02729545|FG000|Participant Flow|Tung's Acupuncture Group|The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
11271912|NCT02729545|FG001|Participant Flow|CPA/EE Group|CPA/EE were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
11271913|NCT02729545|OG000|Outcome|Tung's Acupuncture|The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
11271914|NCT02729545|OG001|Outcome|CPA/EE|Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
11271915|NCT02729545|EG000|Reported Event|Tung's Acupuncture Group|The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
11271916|NCT02729545|EG001|Reported Event|CPA/EE Group|CPA/EE were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
11271917|NCT02729740|BG000|Baseline|Penumbra Smart System|"Penumbra Smart Coil~Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care"
11271918|NCT02729740|FG000|Participant Flow|Penumbra Smart System|"Penumbra Smart Coil~Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care"
11271919|NCT02729740|OG000|Outcome|Penumbra Smart System|"Penumbra Smart Coil~Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care"
11271920|NCT02729740|EG000|Reported Event|Penumbra Smart System|"Penumbra Smart Coil~Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care"
11271921|NCT02729831|BG000|Baseline|Interactive Decision Aid and Usual Care|"Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11271922|NCT02729831|BG001|Baseline|Video Decision Aid and Usual Care|"Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.~Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11271923|NCT02729831|BG002|Baseline|Interactive Decision Aid and Provider Report|"Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271924|NCT02729831|BG003|Baseline|Video Decision Aid and Provider Report|"Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271925|NCT02729831|BG004|Baseline|Total|Total of all reporting groups
11271926|NCT02729831|FG000|Participant Flow|Interactive Decision Aid and Usual Care|"Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11271927|NCT02729831|FG001|Participant Flow|Video Decision Aid and Usual Care|"Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.~Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11337640|NCT03589885|FG001|Participant Flow|Secukinumab 300 mg (2x 1 mL PFS)|Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
11337641|NCT03589885|FG002|Participant Flow|Placebo|Placebo to Secukinumab
11271928|NCT02729831|FG002|Participant Flow|Interactive Decision Aid and Provider Report|"Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271929|NCT02729831|FG003|Participant Flow|Video Decision Aid and Provider Report|"Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271930|NCT02729831|OG000|Outcome|Interactive Decision Aid and Usual Care|"Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11271931|NCT02729831|OG001|Outcome|Video Decision Aid and Usual Care|"Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.~Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11271932|NCT02729831|OG002|Outcome|Interactive Decision Aid and Provider Report|"Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271933|NCT02729831|OG003|Outcome|Video Decision Aid and Provider Report|"Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271934|NCT02729831|EG000|Reported Event|Interactive Decision Aid and Usual Care|"Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis"
11271935|NCT02729831|EG001|Reported Event|Video Decision Aid and Usual Care|"Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.~Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis"
11271936|NCT02729831|EG002|Reported Event|Interactive Decision Aid and Provider Report|"Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
10847362|NCT00282971|OG000|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
10847363|NCT00282971|OG001|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
11271937|NCT02729831|EG003|Reported Event|Video Decision Aid and Provider Report|"Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.~Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis~Provider Report: A short report that includes the patients' goals and treatment preferences"
11271938|NCT02729896|BG000|Baseline|Dose-Escalation FL Cohort 1.4 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.
11271939|NCT02729896|BG001|Baseline|Dose-Escalation and Expansion FL Cohort 1.8 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271940|NCT02729896|BG002|Baseline|Safety Run-in and Expansion DLBCL Cohort|For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271941|NCT02729896|BG003|Baseline|Total|Total of all reporting groups
11337642|NCT03589885|FG003|Participant Flow|Placebo-Secukinumab 300 mg (2 mL AI)|Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL AI up to the end of treatment
11271942|NCT02729896|FG000|Participant Flow|Dose-Escalation FL Cohort 1.4 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.
11271943|NCT02729896|FG001|Participant Flow|Dose-Escalation and Expansion FL Cohort 1.8 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271944|NCT02729896|FG002|Participant Flow|Safety Run-in and Expansion DLBCL Cohort|For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271945|NCT02729896|OG000|Outcome|Dose-Escalation FL Cohort 1.4 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.
11271946|NCT02729896|OG001|Outcome|Dose-Escalation and Expansion FL Cohort 1.8 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271947|NCT02729896|OG002|Outcome|Safety Run-In Phase|For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271948|NCT02729896|OG000|Outcome|Safety Run-In Phase|For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271949|NCT02729896|EG000|Reported Event|Dose-Escalation FL Cohort 1.4 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.
11271950|NCT02729896|EG001|Reported Event|Dose-Escalation and Expansion FL Cohort 1.8 mg|During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271951|NCT02729896|EG002|Reported Event|Safety Run-in and Expansion DLBCL Cohort|For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
11271952|NCT02729909|BG000|Baseline|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271953|NCT02729909|BG001|Baseline|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271954|NCT02729909|BG002|Baseline|Total|Total of all reporting groups
11271955|NCT02729909|FG000|Participant Flow|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271956|NCT02729909|FG001|Participant Flow|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271957|NCT02729909|OG000|Outcome|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271958|NCT02729909|OG001|Outcome|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
10847364|NCT00282971|EG000|Reported Event|Inhaled Insulin|Inhaled insulin plus oral therapy
10847365|NCT00282971|EG001|Reported Event|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
11271959|NCT02729909|EG000|Reported Event|Lubiprostone 24 μg|Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271960|NCT02729909|EG001|Reported Event|Placebo|Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
11271961|NCT02730169|BG000|Baseline|BGS649 0.1 mg|"BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271962|NCT02730169|BG001|Baseline|BGS649 0.3 mg|"BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271963|NCT02730169|BG002|Baseline|BGS649 1.0 mg|"BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271964|NCT02730169|BG003|Baseline|Placebo|"Placebo weekly (3 indistinguishable placebo capsules)~Placebo: Capsules will be taken weekly for a maximum of 24 weeks"
11271965|NCT02730169|BG004|Baseline|Total|Total of all reporting groups
11271966|NCT02730169|FG000|Participant Flow|BGS649 0.1 mg|"BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271967|NCT02730169|FG001|Participant Flow|BGS649 0.3 mg|"BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271968|NCT02730169|FG002|Participant Flow|BGS649 1.0 mg|"BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271969|NCT02730169|FG003|Participant Flow|Placebo|"Placebo weekly (3 indistinguishable placebo capsules)~Placebo: Capsules will be taken weekly for a maximum of 24 weeks"
11271970|NCT02730169|OG000|Outcome|BGS649 0.1 mg|"BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271971|NCT02730169|OG001|Outcome|BGS649 0.3 mg|"BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271972|NCT02730169|OG002|Outcome|BGS649 1.0 mg|"BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271973|NCT02730169|OG003|Outcome|Placebo|"Placebo weekly (3 indistinguishable placebo capsules)~Placebo: Capsules will be taken weekly for a maximum of 24 weeks"
11271974|NCT02730169|EG000|Reported Event|BGS649 0.1 mg|"BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271975|NCT02730169|EG001|Reported Event|BGS649 0.3 mg|"BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271976|NCT02730169|EG002|Reported Event|BGS649 1.0 mg|"BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)~BGS649: Capsules will be taken weekly for a maximum of 24 weeks"
11271977|NCT02730169|EG003|Reported Event|Placebo|"Placebo weekly (3 indistinguishable placebo capsules)~Placebo: Capsules will be taken weekly for a maximum of 24 weeks"
11271978|NCT02730195|BG000|Baseline|Pioglitazone & TKI Therapy|"Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.~Pioglitazone: Given PO~Tyrosine Kinase Inhibitor (TKI): Given TKI therapy"
11271979|NCT02730195|FG000|Participant Flow|Pioglitazone & TKI Therapy|"Patients receive pioglitazone PO once a day (QD) on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.~Pioglitazone: Given PO~Tyrosine Kinase Inhibitor (TKI): Given TKI therapy"
11271980|NCT02730195|OG000|Outcome|Pioglitazone & TKI Therapy|"Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.~Pioglitazone: Given PO~Tyrosine Kinase Inhibitor (TKI): Given TKI therapy"
11271981|NCT02730195|EG000|Reported Event|Pioglitazone & TKI Therapy|"Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.~Pioglitazone: Given PO~Tyrosine Kinase Inhibitor (TKI): Given TKI therapy"
11271982|NCT02730208|BG000|Baseline|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
11271983|NCT02730208|BG001|Baseline|Placebo|Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
11271984|NCT02730208|BG002|Baseline|Total|Total of all reporting groups
11271985|NCT02730208|FG000|Participant Flow|TEZ/IVA|Participants received TEZ 100 milligram (mg)/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
11271986|NCT02730208|FG001|Participant Flow|Placebo|Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
11271987|NCT02730208|OG000|Outcome|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
11271988|NCT02730208|OG001|Outcome|Placebo|Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
11271989|NCT02730208|EG000|Reported Event|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
11271990|NCT02730208|EG001|Reported Event|Placebo|Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
11337643|NCT03589885|FG004|Participant Flow|Placebo-Secukinumab 300 mg (2 x 1 mL PFS)|Placebo patients up to Week 12 who thereafter received secukinumab in 2 x 1 mL PFS up to the end of treatment
11271991|NCT02730234|BG000|Baseline|JetStream XC With Balloon Angioplasty|"The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.~JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic."
11271992|NCT02730234|FG000|Participant Flow|JetStream XC With Balloon Angioplasty|"The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.~JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic."
11271993|NCT02730234|OG000|Outcome|JetStream XC With Balloon Angioplasty|"The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.~JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic."
11271994|NCT02730234|EG000|Reported Event|JetStream XC With Balloon Angioplasty|"The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.~JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic."
11271995|NCT02730247|BG000|Baseline|Ramucirumab + Nab-paclitaxel|"8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle~100 mg/m^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle"
11271996|NCT02730247|FG000|Participant Flow|Ramucirumab + Nab-paclitaxel|"8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle~100 mg/m^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle"
11271997|NCT02730247|OG000|Outcome|Ramucirumab + Nab-paclitaxel|"8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle~100 mg/m^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle"
11271998|NCT02730247|EG000|Reported Event|Ramucirumab + Nab-paclitaxel|"8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle~100 mg/m^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle"
11271999|NCT02730260|BG000|Baseline|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
11272000|NCT02730260|BG001|Baseline|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
11272001|NCT02730260|BG002|Baseline|Total|Total of all reporting groups
11272002|NCT02730260|FG000|Participant Flow|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
11272003|NCT02730260|FG001|Participant Flow|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
11272004|NCT02730260|OG000|Outcome|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
11272005|NCT02730260|OG001|Outcome|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
11272006|NCT02730260|EG000|Reported Event|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
11272007|NCT02730260|EG001|Reported Event|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
11272008|NCT02730351|BG000|Baseline|All Treatment Combined|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 µg BID following which the participants were randomized to one of the following two treatment sequences in a ratio of 1:1: FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in treatment period 1 followed by FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 2 or FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 1 followed by FF/VI 100/25 µg once daily (QD) via ELLIPTA + Placebo BID via DISKUS in treatment period 2. All participants entered a 2-week single blind wash-out period on FP 250 µg BID between the two treatment periods. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
11272009|NCT02730351|FG000|Participant Flow|FF/VI 100/25 µg Followed by FP 250 µg|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 microgram (µg) twice daily (BID) following which the participants were randomized to receive FF/VI 100/25 µg once daily (QD) via ELLIPTA + Placebo BID via DISKUS in treatment period 1 followed by a 2-week single blind wash-out period on FP 250 µg BID. The participants then received FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 2. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
11337644|NCT03589885|OG000|Outcome|Secukinumab 2 mL Auto-injector|Secukinumab 300 mg provided in 2 mL auto-injector form
11337645|NCT03589885|OG001|Outcome|Secukinumab 1 mL Prefilled Syringe|Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
11337646|NCT03589885|OG002|Outcome|Placebo|Placebo to secukinumab
11337647|NCT03589885|OG002|Outcome|Placebo|Placebo to Secukinumab
11337648|NCT03589885|OG002|Outcome|Placebo|Placebo to secuinumab
11272010|NCT02730351|FG001|Participant Flow|FP 250 µg Followed by FF/VI 100/25 µg|After screening, the eligible participants entered a 4-week single blind run-in period on FP 250 µg BID following which the participants were randomized to receive FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in treatment period 1 followed by a 2-week single blind wash-out period on FP 250 µg BID. The participants then received FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in treatment period 2. The participants were followed up for approximately 7 days after completing Treatment Period 2. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
11272011|NCT02730351|OG000|Outcome|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|Participants were administered FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
11272012|NCT02730351|OG001|Outcome|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|Participants were administered FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA in one of the two treatment periods. Each treatment period was of 2 weeks with a single blind 2 week wash-out period on FP 250 µg BID between the treatment periods. Albuterol/salbutamol was issued for rescue use during the run-in, wash-out and treatment periods as needed.
11272013|NCT02730351|EG000|Reported Event|FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS|FF/VI 100/25 µg QD via ELLIPTA + Placebo BID via DISKUS
11272014|NCT02730351|EG001|Reported Event|FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA|FP 250 µg BID via DISKUS + Placebo QD via ELLIPTA
11272015|NCT02730377|BG000|Baseline|Liraglutide 1.8 mg|Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks.
11272016|NCT02730377|BG001|Baseline|Oral Antidiabetic Drug|Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
11272017|NCT02730377|BG002|Baseline|Total|Total of all reporting groups
11272018|NCT02730377|FG000|Participant Flow|Liraglutide 1.8 mg|Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks.
11272019|NCT02730377|FG001|Participant Flow|Oral Antidiabetic Drug|Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
11272020|NCT02730377|OG000|Outcome|Liraglutide 1.8 mg|Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks.
11272021|NCT02730377|OG001|Outcome|Oral Antidiabetic Drug|Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
11272022|NCT02730377|EG000|Reported Event|Liraglutide 1.8 mg|Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks.
11272023|NCT02730377|EG001|Reported Event|Oral Antidiabetic Drug|Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
11272024|NCT02730403|BG000|Baseline|Treatment As Usual|Patients admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
11272025|NCT02730403|FG000|Participant Flow|Treatment As Usual|Patients admitted to detoxification or short term residential programs associated with CTN-0051 for Opioid Use Disorder (OUD).
11272026|NCT02730403|OG000|Outcome|Treatment As Usual|Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
11272027|NCT02730403|OG000|Outcome|Treatment As Usual|Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
11272028|NCT02730403|EG000|Reported Event|Treatment As Usual|Patients who were admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
11272029|NCT02730455|BG000|Baseline|Placebo|Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272030|NCT02730455|BG001|Baseline|Natalizumab 300 mg IV|Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272031|NCT02730455|BG002|Baseline|Natalizumab 600 mg IV|Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272032|NCT02730455|BG003|Baseline|Total|Total of all reporting groups
11272033|NCT02730455|FG000|Participant Flow|Placebo|Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272034|NCT02730455|FG001|Participant Flow|Natalizumab 300 mg IV|Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272035|NCT02730455|FG002|Participant Flow|Natalizumab 600 mg IV|Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272036|NCT02730455|OG000|Outcome|Placebo|Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272037|NCT02730455|OG001|Outcome|Natalizumab 300 mg IV|Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272038|NCT02730455|OG002|Outcome|Natalizumab 600 mg IV|Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272039|NCT02730455|EG000|Reported Event|Placebo|Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272040|NCT02730455|EG001|Reported Event|Natalizumab 300 mg IV|Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272041|NCT02730455|EG002|Reported Event|Natalizumab 600 mg IV|Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
11272042|NCT02730598|BG000|Baseline|Hybrid Training System (HTS)|"HTS stimulation while walking at a comfortable pace for 30 minutes.~Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks."
11272043|NCT02730598|BG001|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|"Sensory TENS while walking at a comfortable pace for 30 minutes.~Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS."
11272044|NCT02730598|BG002|Baseline|Total|Total of all reporting groups
11272045|NCT02730598|FG000|Participant Flow|Hybrid Training System (HTS)|"HTS stimulation while walking at a comfortable pace for 30 minutes.~Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks."
11272046|NCT02730598|FG001|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|"Sensory TENS while walking at a comfortable pace for 30 minutes.~Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS."
11092298|NCT01539070|FG000|Participant Flow|Eating and Physical Activity Counseling|"Eating and physical activity counseling: The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
11272047|NCT02730598|OG000|Outcome|Hybrid Training System (HTS)|"HTS stimulation while walking at a comfortable pace for 30 minutes.~Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks."
11272048|NCT02730598|OG001|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|"Sensory TENS while walking at a comfortable pace for 30 minutes.~Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS."
11272049|NCT02730598|EG000|Reported Event|Hybrid Training System (HTS)|"HTS stimulation while walking at a comfortable pace for 30 minutes.~Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks."
11272050|NCT02730598|EG001|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|"Sensory TENS while walking at a comfortable pace for 30 minutes.~Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS."
11272051|NCT02730663|BG000|Baseline|Niti-S SPAXUS Stent|"Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)~Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage"
11272052|NCT02730663|FG000|Participant Flow|Niti-S SPAXUS Stent|"Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)~Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage"
11272053|NCT02730663|OG000|Outcome|Niti-S SPAXUS Stent|"Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)~Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage"
11272054|NCT02730663|EG000|Reported Event|Niti-S SPAXUS Stent|"Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)~Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage"
11272055|NCT02730728|BG000|Baseline|Single Shot Adductor Canal Block|"adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11272056|NCT02730728|BG001|Baseline|24 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272057|NCT02730728|BG002|Baseline|48 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272058|NCT02730728|BG003|Baseline|Total|Total of all reporting groups
11272059|NCT02730728|FG000|Participant Flow|Single Shot Adductor Canal Block|"adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11272060|NCT02730728|FG001|Participant Flow|24 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272061|NCT02730728|FG002|Participant Flow|48 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11092299|NCT01539070|FG001|Participant Flow|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
11272062|NCT02730728|OG000|Outcome|Single Shot Adductor Canal Block|"adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11272063|NCT02730728|OG001|Outcome|24 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272064|NCT02730728|OG002|Outcome|48 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272065|NCT02730728|EG000|Reported Event|Single Shot Adductor Canal Block|"adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA~20ml bolus of 0.5% ropivicaine: Local anesthetic"
11272066|NCT02730728|EG001|Reported Event|24 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272067|NCT02730728|EG002|Reported Event|48 Hour Continuous Adductor Canal Block|"adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA~0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic~5ml bolus of 0.5% ropivicaine: Local anesthetic"
11272068|NCT02730819|BG000|Baseline|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
11272069|NCT02730819|FG000|Participant Flow|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
11272070|NCT02730819|OG000|Outcome|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
11272071|NCT02730819|EG000|Reported Event|Illuminate Cream|Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
11272072|NCT02730871|BG000|Baseline|Simbrinza + Duotrav|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272073|NCT02730871|BG001|Baseline|Vehicle + Duotrav|Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272074|NCT02730871|BG002|Baseline|Total|Total of all reporting groups
11272075|NCT02730871|FG000|Participant Flow|Simbrinza + Duotrav|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272076|NCT02730871|FG001|Participant Flow|Vehicle + Duotrav|Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272077|NCT02730871|OG000|Outcome|Simbrinza + Duotrav|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272078|NCT02730871|OG001|Outcome|Vehicle + Duotrav|Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
11272079|NCT02730871|EG000|Reported Event|Simbrinza + Duotrav|All subjects exposed to brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension plus travoprost 0.004%/timolol 0.5% solution
11272080|NCT02730871|EG001|Reported Event|Vehicle + Duotrav|All subjects exposed to brinzolamide/brimonidine vehicle plus travoprost 0.004%/timolol 0.5% solution
11272081|NCT02730884|BG000|Baseline|Rigosertib|"Participants receive oral Rigosertib under fasting conditions twice a day on a continuous basis. Quality of life questionnaire completed on Day 1 of Cycle 1.~Rigosertib: Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.~Questionnaire: Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete."
11272082|NCT02730884|FG000|Participant Flow|Rigosertib|"Participants receive oral Rigosertib under fasting conditions twice a day on a continuous basis. Quality of life questionnaire completed on Day 1 of Cycle 1.~Rigosertib: Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.~Questionnaire: Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete."
11272083|NCT02730884|OG000|Outcome|Rigosertib|"Participants receive oral Rigosertib under fasting conditions twice a day on a continuous basis. Quality of life questionnaire completed on Day 1 of Cycle 1.~Rigosertib: Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.~Questionnaire: Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete."
11272084|NCT02730884|EG000|Reported Event|Rigosertib|"Participants receive oral Rigosertib under fasting conditions twice a day on a continuous basis. Quality of life questionnaire completed on Day 1 of Cycle 1.~Rigosertib: Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.~Questionnaire: Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete."
11272085|NCT02730962|BG000|Baseline|Antibiotics Prior to FMT|"One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg.~Vancomycin: Vancomycin 3 times a day for 7 days~Neomycin: Neomycin 3 times a day for 1 day~Clindamycin: Clindamycin 3 times a day for 5 days~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272086|NCT02730962|BG001|Baseline|Placebo Prior to FMT|"One week prior to FMT, a course of three sugar pills identical to each antibiotic.~Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272087|NCT02730962|BG002|Baseline|Total|Total of all reporting groups
11272088|NCT02730962|FG000|Participant Flow|Antibiotics Prior to FMT|"One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg.~Vancomycin: Vancomycin 3 times a day for 7 days~Neomycin: Neomycin 3 times a day for 1 day~Clindamycin: Clindamycin 3 times a day for 5 days~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272089|NCT02730962|FG001|Participant Flow|Placebo Prior to FMT|"One week prior to FMT, a course of three sugar pills identical to each antibiotic.~Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272090|NCT02730962|OG000|Outcome|Antibiotics Prior to FMT|"One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg.~Vancomycin: Vancomycin 3 times a day for 7 days~Neomycin: Neomycin 3 times a day for 1 day~Clindamycin: Clindamycin 3 times a day for 5 days~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272091|NCT02730962|OG001|Outcome|Placebo Prior to FMT|"One week prior to FMT, a course of three sugar pills identical to each antibiotic.~Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272092|NCT02730962|EG000|Reported Event|Antibiotics Prior to FMT|"One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg.~Vancomycin: Vancomycin 3 times a day for 7 days~Neomycin: Neomycin 3 times a day for 1 day~Clindamycin: Clindamycin 3 times a day for 5 days~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11337649|NCT03589885|OG003|Outcome|Placebo-Secukinumab 300 mg (2 mL Auto-injector)|Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL aI up to the end of treatment
11272093|NCT02730962|EG001|Reported Event|Placebo Prior to FMT|"One week prior to FMT, a course of three sugar pills identical to each antibiotic.~Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic~Fecal Microbiota Transplantation: FMT conducted via colonoscopy"
11272094|NCT02730988|BG000|Baseline|Weight Loss Lifestyle Counseling|The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
11272095|NCT02730988|BG001|Baseline|Weight Stable Lifestyle Counseling|The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
11272096|NCT02730988|BG002|Baseline|Total|Total of all reporting groups
11272097|NCT02730988|FG000|Participant Flow|Weight Loss Lifestyle Counseling|The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
11272098|NCT02730988|FG001|Participant Flow|Weight Stable Lifestyle Counseling|The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
11272099|NCT02730988|OG000|Outcome|Weight Loss Lifestyle Counseling|The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
11272100|NCT02730988|OG001|Outcome|Weight Stable Lifestyle Counseling|The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
11272101|NCT02730988|EG000|Reported Event|Weight Loss Lifestyle Counseling|The high protein weight loss group follows the Medifast 4 & 2 & 1 Plan™, a 1200 calorie, high protein diet targeting ~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling.
11272102|NCT02730988|EG001|Reported Event|Weight Stable Lifestyle Counseling|The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff.
11272103|NCT02731131|BG000|Baseline|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
11272104|NCT02731131|BG001|Baseline|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
11272105|NCT02731131|BG002|Baseline|Total|Total of all reporting groups
11272106|NCT02731131|FG000|Participant Flow|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
11272107|NCT02731131|FG001|Participant Flow|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
11272108|NCT02731131|OG000|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
11272109|NCT02731131|OG001|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
11272110|NCT02731131|EG000|Reported Event|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
11272111|NCT02731131|EG001|Reported Event|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
11272112|NCT02731157|BG000|Baseline|All Study Participants|Each participant in this 4 subject pilot study acted as their own control. Red cell exchanges (RCEs) occurred approximately every month and, over a 6 month period, the sequence of exchanges for each patient was: SRRRSS, where S=standard and R=rejuvenated RCEs.
11272113|NCT02731157|FG000|Participant Flow|All Study Participants|Each participant in this 4 subject pilot study acted as their own control. Red cell exchanges (RCEs) occurred approximately every month and, over a 6 month period, the sequence of exchanges for each patient was: SRRRSS, where S=standard and R=rejuvenated RCEs.
11272114|NCT02731157|OG000|Outcome|Transfusion With Rejuvenated Red Blood Cells (RBCs)|"Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.~Rejuvesol~Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study."
10970200|NCT00909363|OG001|Outcome|Healthy Volunteers|8 normal subjects will be studied for degree of platelet activation from one blood draw by collaborator Alan Michelson at Boston Childrens Hospital
11272115|NCT02731157|OG001|Outcome|Transfusion With Standard Red Blood Cells|"Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.~Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study."
11272116|NCT02731157|EG000|Reported Event|Transfusion With Standard RBCs|Each participant received three standard red cell exchanges.
11272117|NCT02731157|EG001|Reported Event|Transfusion With Rejuvenated RBCs|Each participant received three rejuvenated red cell exchanges.
11272118|NCT02731300|BG000|Baseline|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272119|NCT02731300|BG001|Baseline|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272120|NCT02731300|BG002|Baseline|Total|Total of all reporting groups
11272121|NCT02731300|FG000|Participant Flow|Active tDCS|"2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272122|NCT02731300|FG001|Participant Flow|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272123|NCT02731300|OG000|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272124|NCT02731300|OG001|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272125|NCT02731300|EG000|Reported Event|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272126|NCT02731300|EG001|Reported Event|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
11272127|NCT02731313|BG000|Baseline|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma Samples|"Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned~Trastuzumab: Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions."
11272128|NCT02731313|FG000|Participant Flow|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
11272129|NCT02731313|OG000|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
11272130|NCT02731313|EG000|Reported Event|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
11272131|NCT02731469|BG000|Baseline|BCD-131, 0.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously~BCD-131"
11272132|NCT02731469|BG001|Baseline|BCD-131, 0.15 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously~BCD-131"
11272133|NCT02731469|BG002|Baseline|BCD-131, 0.40 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously~BCD-131"
11272134|NCT02731469|BG003|Baseline|BCD-131, 1.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously~BCD-131"
11272135|NCT02731469|BG004|Baseline|BCD-131, 1.70 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously~BCD-131"
11272136|NCT02731469|BG005|Baseline|BCD-131, 2.25 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously~BCD-131"
11272137|NCT02731469|BG006|Baseline|BCD-131, 4.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously~BCD-131"
11272138|NCT02731469|BG007|Baseline|Mircera®, 1.20 mcg/kg Subcutaneously|"Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously~Mircera®"
11272139|NCT02731469|BG008|Baseline|Aranesp®, 0.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously~Aranesp®"
11272140|NCT02731469|BG009|Baseline|BCD-131, Optimal Dose, Intravenously|"Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously~BCD-131"
11272141|NCT02731469|BG010|Baseline|BCD-131, Optimal Dose, Subcutaneously|"Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously~BCD-131"
11272142|NCT02731469|BG011|Baseline|Total|Total of all reporting groups
10970201|NCT00909363|OG002|Outcome|Was Patients Blood Drawing Only|WAS pts who were ineligible for or did not want eltrombopag treatment
11272143|NCT02731469|FG000|Participant Flow|BCD-131, 0.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously~BCD-131"
11272144|NCT02731469|FG001|Participant Flow|BCD-131, 0.15 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously~BCD-131"
11272145|NCT02731469|FG002|Participant Flow|BCD-131, 0.40 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously~BCD-131"
11272146|NCT02731469|FG003|Participant Flow|BCD-131, 1.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously~BCD-131"
11272147|NCT02731469|FG004|Participant Flow|BCD-131, 1.70 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously~BCD-131"
11272148|NCT02731469|FG005|Participant Flow|BCD-131, 2.25 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously~BCD-131"
11272149|NCT02731469|FG006|Participant Flow|BCD-131, 4.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously~BCD-131"
11272150|NCT02731469|FG007|Participant Flow|Mircera®, 1.20 mcg/kg Subcutaneously|"Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously~Mircera®"
11272151|NCT02731469|FG008|Participant Flow|Aranesp®, 0.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously~Aranesp®"
11272152|NCT02731469|FG009|Participant Flow|BCD-131, Optimal Dose, Intravenously|"Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously~BCD-131"
11214440|NCT02292082|FG001|Participant Flow|Peri-Articular Injections and Adductor Canal Block|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Adductor canal block technique:~Supine position, after IV sedation~Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches~Femoral artery will be identified in the adductor canal deep to the Sartorius muscle~15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone~Local anesthetic will be delivered periarterial between 12 and 6 o'clock~Intravenous sedation with midazolam and propofol.~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 20 ml 0.25% bupivacaine~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone~8 MHz. Chiba needle, 22 G / 4 inches"
11214441|NCT02292082|OG000|Outcome|Peri-Articular Injections Only|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Surgeon will perform the periarticular injections:~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine~Intravenous sedation with midazolam and propofol.~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone"
11214442|NCT02292082|OG001|Outcome|Peri-Articular Injections and Adductor Canal Block|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Adductor canal block technique:~Supine position, after IV sedation~Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches~Femoral artery will be identified in the adductor canal deep to the Sartorius muscle~15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone~Local anesthetic will be delivered periarterial between 12 and 6 o'clock~Intravenous sedation with midazolam and propofol.~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 20 ml 0.25% bupivacaine~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone~8 MHz. Chiba needle, 22 G / 4 inches"
11214443|NCT02292082|EG000|Reported Event|Peri-Articular Injections Only|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Surgeon will perform the periarticular injections:~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine~Intravenous sedation with midazolam and propofol.~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone"
11214444|NCT02292082|EG001|Reported Event|Peri-Articular Injections and Adductor Canal Block|"Intra-Operatively~Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)~Adductor canal block technique:~Supine position, after IV sedation~Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches~Femoral artery will be identified in the adductor canal deep to the Sartorius muscle~15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone~Local anesthetic will be delivered periarterial between 12 and 6 o'clock~Intravenous sedation with midazolam and propofol.~First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc~Second superficial injection prior to closure. 20 ml 0.25% bupivacaine~Bupivacaine~Morphine~Methylprednisolone~Cefazolin~Normal saline~Midazolam~Propofol~Dexamethasone~8 MHz. Chiba needle, 22 G / 4 inches"
11214445|NCT02292186|BG000|Baseline|Revusiran (ALN-TTRSC)|All patients who received at least 1 dose of revusiran
11214446|NCT02292186|FG000|Participant Flow|Revusiran (ALN-TTRSC)|All patients who received at least 1 dose of revusiran
11214447|NCT02292186|OG000|Outcome|Revusiran (ALN-TTRSC)|All patients who received at least 1 dose of revusiran
11214448|NCT02292186|EG000|Reported Event|Revusiran (ALN-TTRSC)|All patients who received at least 1 dose of revusiran
11214449|NCT02292212|BG000|Baseline|Single Arm|Total 16 weeks, divided to 3 phases, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
11214450|NCT02292212|FG000|Participant Flow|Single Arm|Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
11214451|NCT02292212|OG000|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
11214452|NCT02292212|OG001|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
11214453|NCT02292212|OG002|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
11214454|NCT02292212|OG000|Outcome|Pre-ViE Phase|Two weeks (six sessions) on the control dialyzer
11214455|NCT02292212|OG001|Outcome|ViE Phase|12 weeks (36 sessions) on the ViE-21
11214456|NCT02292212|OG002|Outcome|Post ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
11214457|NCT02292212|EG000|Reported Event|Pre-ViE Phase|Two weeks (six sessions) on control dialyzer
11214458|NCT02292212|EG001|Reported Event|ViE Phase|12 weeks (36 sessions) on ViE-21
11214459|NCT02292212|EG002|Reported Event|Post-ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
11214460|NCT02292433|BG000|Baseline|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11272153|NCT02731469|FG010|Participant Flow|BCD-131, Optimal Dose, Subcutaneously|"Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously~BCD-131"
11272154|NCT02731469|OG000|Outcome|BCD-131, 0.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously~BCD-131"
11272155|NCT02731469|OG001|Outcome|BCD-131, 0.15 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously~BCD-131"
11214461|NCT02292433|BG001|Baseline|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11214462|NCT02292433|BG002|Baseline|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11214463|NCT02292433|BG003|Baseline|Total|Total of all reporting groups
11214464|NCT02292433|FG000|Participant Flow|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11214465|NCT02292433|FG001|Participant Flow|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11214466|NCT02292433|FG002|Participant Flow|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
11214467|NCT02292433|OG000|Outcome|PF--04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
11214468|NCT02292433|OG001|Outcome|PF--04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
11214469|NCT02292433|OG002|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
11214470|NCT02292433|EG000|Reported Event|PF--04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
11214471|NCT02292433|EG001|Reported Event|PF--04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
11214472|NCT02292433|EG002|Reported Event|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
11214473|NCT02292446|BG000|Baseline|All Patients|All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
11214474|NCT02292446|FG000|Participant Flow|All Patients|All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
11214475|NCT02292446|OG000|Outcome|All Patients|All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
11214476|NCT02292446|OG000|Outcome|Baseline|Hematocrit level at baseline
11214477|NCT02292446|OG001|Outcome|Post-baseline|Post-baseline hematocrit value
11214478|NCT02292446|OG002|Outcome|Change|Change from baseline
11214479|NCT02292446|EG000|Reported Event|All Patients|All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
11214480|NCT02292537|BG000|Baseline|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
11214481|NCT02292537|BG001|Baseline|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
11214482|NCT02292537|BG002|Baseline|Total|Total of all reporting groups
11214483|NCT02292537|FG000|Participant Flow|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
10970202|NCT00909363|OG002|Outcome|WAS Pts: Blood Drawing Only|WASpatients who were not eligible for or did not want treatment with eltrombopag and had blood drawn once
10970203|NCT00909363|OG002|Outcome|WAS Pts: Blood Drawing Only|WAS patients who are either no eligible for treatment or do not want it and agreed to have blood drawn once
10970204|NCT00909363|OG002|Outcome|Was Patients Blood Drawing Only|Was patients ineligible for or not interested in eltrombopag treatment
11214484|NCT02292537|FG001|Participant Flow|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
11214485|NCT02292537|OG000|Outcome|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
11214486|NCT02292537|OG001|Outcome|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
11214487|NCT02292537|EG000|Reported Event|Sham Procedure|Sham comparator on Days 1, 29, 85 and 274.
11214488|NCT02292537|EG001|Reported Event|Nusinersen|Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.
11214489|NCT02292719|BG000|Baseline|Arm A (Genotype [GT]3, Noncirrhotic)|Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
11214490|NCT02292719|BG001|Baseline|Arm B (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
11214491|NCT02292719|BG002|Baseline|Arm C (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
11214492|NCT02292719|BG003|Baseline|Arm D (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
11214493|NCT02292719|BG004|Baseline|Arm E (GT3, Cirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
11214494|NCT02292719|BG005|Baseline|Arm F (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
11214495|NCT02292719|BG006|Baseline|Total|Total of all reporting groups
11214496|NCT02292719|FG000|Participant Flow|Arm A (Genotype [GT]3, Noncirrhotic)|Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
11214497|NCT02292719|FG001|Participant Flow|Arm B (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
11214498|NCT02292719|FG002|Participant Flow|Arm C (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
11214499|NCT02292719|FG003|Participant Flow|Arm D (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
11214500|NCT02292719|FG004|Participant Flow|Arm E (GT3, Cirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
11214501|NCT02292719|FG005|Participant Flow|Arm F (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
11214502|NCT02292719|OG000|Outcome|Arm A (Genotype [GT]3, Noncirrhotic)|Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
11214503|NCT02292719|OG001|Outcome|Arm B (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
11214504|NCT02292719|OG002|Outcome|Arm C (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
11214505|NCT02292719|OG003|Outcome|Arm D (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
11214506|NCT02292719|OG004|Outcome|Arm E (GT3, Cirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
11214507|NCT02292719|OG005|Outcome|Arm F (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
11214508|NCT02292719|EG000|Reported Event|Arm A (Genotype [GT]3, Noncirrhotic)|Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD ) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
11214509|NCT02292719|EG001|Reported Event|Arm B (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
11214510|NCT02292719|EG002|Reported Event|Arm C (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
11214511|NCT02292719|EG003|Reported Event|Arm D (GT2, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
11214512|NCT02292719|EG004|Reported Event|Arm E (GT3, Cirrhotic)|OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
11214513|NCT02292719|EG005|Reported Event|Arm F (GT3, Noncirrhotic)|OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
11214514|NCT02292771|BG000|Baseline|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11214515|NCT02292771|BG001|Baseline|Atosiban|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214516|NCT02292771|BG002|Baseline|Total|Total of all reporting groups
11214517|NCT02292771|FG000|Participant Flow|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11272156|NCT02731469|OG002|Outcome|BCD-131, 0.40 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously~BCD-131"
11214518|NCT02292771|FG001|Participant Flow|Atosiban|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214519|NCT02292771|OG000|Outcome|Retosiban|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11214520|NCT02292771|OG001|Outcome|Atosiban|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214521|NCT02292771|EG000|Reported Event|Retosiban (Maternal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11214522|NCT02292771|EG001|Reported Event|Atosiban (Maternal)|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214523|NCT02292771|EG002|Reported Event|Retosiban (Fetal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11214524|NCT02292771|EG003|Reported Event|Atosiban (Fetal)|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214525|NCT02292771|EG004|Reported Event|Retosiban (Neonatal)|Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
11214526|NCT02292771|EG005|Reported Event|Atosiban (Neonatal)|Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
11214527|NCT02292784|BG000|Baseline|Placebo (200719 Study)|All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous [IV] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study did not require any medical interventions or study visits to an investigational site.
11214528|NCT02292784|BG001|Baseline|Atosiban (200721 Study)|All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214529|NCT02292784|BG002|Baseline|Retosiban (200719 and 200721 Study)|All infants and children born to women who received retosiban (6 mg IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214530|NCT02292784|BG003|Baseline|Total|Total of all reporting groups
11214531|NCT02292784|FG000|Participant Flow|Placebo (200719 Study)|All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous [IV] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study did not require any medical interventions or study visits to an investigational site.
11214532|NCT02292784|FG001|Participant Flow|Atosiban (200721 Study)|All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214533|NCT02292784|FG002|Participant Flow|Retosiban (200719 and 200721 Study)|All infants and children born to women who received retosiban (6 mg IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11272157|NCT02731469|OG003|Outcome|BCD-131, 1.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously~BCD-131"
11272158|NCT02731469|OG004|Outcome|BCD-131, 1.70 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously~BCD-131"
11272159|NCT02731469|OG005|Outcome|BCD-131, 2.25 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously~BCD-131"
11272160|NCT02731469|OG006|Outcome|BCD-131, 4.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously~BCD-131"
11272161|NCT02731469|OG007|Outcome|Mircera®, 1.20 mcg/kg Subcutaneously|"Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously~Mircera®"
11272162|NCT02731469|OG008|Outcome|Aranesp®, 0.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously~Aranesp®"
11272163|NCT02731469|OG009|Outcome|BCD-131, Optimal Dose, Intravenously|"Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously~BCD-131"
11272164|NCT02731469|OG010|Outcome|BCD-131, Optimal Dose, Subcutaneously|"Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously~BCD-131"
11272165|NCT02731469|EG000|Reported Event|BCD-131, 0.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously~BCD-131"
11272166|NCT02731469|EG001|Reported Event|BCD-131, 0.15 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously~BCD-131"
10847366|NCT00282984|BG000|Baseline|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
11272167|NCT02731469|EG002|Reported Event|BCD-131, 0.40 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously~BCD-131"
11272168|NCT02731469|EG003|Reported Event|BCD-131, 1.05 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously~BCD-131"
11272169|NCT02731469|EG004|Reported Event|BCD-131, 1.70 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously~BCD-131"
11272170|NCT02731469|EG005|Reported Event|BCD-131, 2.25 mcg/kg SC|"Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously~BCD-131"
11272171|NCT02731469|EG006|Reported Event|BCD-131, 4.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously~BCD-131"
11272172|NCT02731469|EG007|Reported Event|Mircera®, 1.20 mcg/kg Subcutaneously|"Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously~Mircera®"
11272173|NCT02731469|EG008|Reported Event|Aranesp®, 0.45 mcg/kg Subcutaneously|"Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously~Aranesp®"
11272174|NCT02731469|EG009|Reported Event|BCD-131, Optimal Dose, Intravenously|"Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously~BCD-131"
11272175|NCT02731469|EG010|Reported Event|BCD-131, Optimal Dose, Subcutaneously|"Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously~BCD-131"
11272176|NCT02731638|BG000|Baseline|Intrastromal Voriconazole Plus Natamycin|"Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis~Intrastromal voriconazole: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272177|NCT02731638|BG001|Baseline|Natamycin Alone|"Standard of care topical treatment for fungal keratitis~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272178|NCT02731638|BG002|Baseline|Total|Total of all reporting groups
11272179|NCT02731638|FG000|Participant Flow|Intrastromal Voriconazole Plus Natamycin|"Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis~Intrastromal voriconazole: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272180|NCT02731638|FG001|Participant Flow|Natamycin Alone|"Standard of care topical treatment for fungal keratitis~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272181|NCT02731638|OG000|Outcome|Intrastromal Voriconazole Plus Natamycin|"Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis~Intrastromal voriconazole: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272182|NCT02731638|OG001|Outcome|Natamycin Alone|"Standard of care topical treatment for fungal keratitis~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272183|NCT02731638|EG000|Reported Event|Intrastromal Voriconazole Plus Natamycin|"Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis~Intrastromal voriconazole: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272184|NCT02731638|EG001|Reported Event|Natamycin Alone|"Standard of care topical treatment for fungal keratitis~Natamycin: Subjects will receive topical 5% natamycin drops hourly for 3 days."
11272185|NCT02731690|BG000|Baseline|UX001 6g/Day|Open-label UX001 6000 mg (6 g) total daily dose administered orally divided into a 3-times-daily regimen.
11272186|NCT02731690|FG000|Participant Flow|UX001 6g/Day|Open-label UX001 6000 mg (6 g) total daily dose administered orally divided into a 3-times-daily regimen.
11272187|NCT02731690|OG000|Outcome|UX001 6g/Day|Open-label UX001 6000 mg (6 g) total daily dose administered orally divided into a 3-times-daily regimen.
11272188|NCT02731690|EG000|Reported Event|Ace-ER 6 g/Day|Open-label UX001 6000 mg (6 g) total daily dose administered orally divided into a 3-times-daily regimen.
11337650|NCT03589885|OG004|Outcome|Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe)|Placebo patients up to Week 12 who thereafter received secukinumab in 2x 1mL PFS up to the end of treatment
11337651|NCT03589885|OG000|Outcome|PRE- Module by Visit|PRE- Module by Visit score- Entire Treatment Period (Safety set)
11272189|NCT02731729|BG000|Baseline|Ipilimumab and Nivolumab|"For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.~ipilimumab~nivolumab"
11272190|NCT02731729|BG001|Baseline|Ipilimumab|"In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.~ipilimumab"
11272191|NCT02731729|BG002|Baseline|Total|Total of all reporting groups
11272192|NCT02731729|FG000|Participant Flow|Ipilimumab and Nivolumab|"For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.~ipilimumab~nivolumab"
11272193|NCT02731729|FG001|Participant Flow|Ipilimumab|"In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.~ipilimumab"
11272194|NCT02731729|OG000|Outcome|Ipilimumab and Nivolumab|"For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.~ipilimumab~nivolumab"
11272195|NCT02731729|OG001|Outcome|Ipilimumab|"In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.~ipilimumab"
11272196|NCT02731729|EG000|Reported Event|Ipilimumab and Nivolumab|"For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.~ipilimumab~nivolumab"
11272197|NCT02731729|EG001|Reported Event|Ipilimumab|"In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.~ipilimumab"
11272198|NCT02731742|BG000|Baseline|MK-1966 70 mg+SD-101 1 mg|Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272199|NCT02731742|BG001|Baseline|MK-1966 70 mg+SD-101 4 mg|Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272200|NCT02731742|BG002|Baseline|MK-1966 210 mg+SD-101 4 mg|Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272201|NCT02731742|BG003|Baseline|MK-1966 700 mg+SD-101 4 mg|Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272202|NCT02731742|BG004|Baseline|Total|Total of all reporting groups
11272203|NCT02731742|FG000|Participant Flow|MK-1966 70 mg+SD-101 1 mg|Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272204|NCT02731742|FG001|Participant Flow|MK-1966 70 mg+SD-101 4 mg|Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272205|NCT02731742|FG002|Participant Flow|MK-1966 210 mg+SD-101 4 mg|Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
10847367|NCT00282984|BG001|Baseline|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
10847368|NCT00282984|BG002|Baseline|Total|Total of all reporting groups
11272206|NCT02731742|FG003|Participant Flow|MK-1966 700 mg+SD-101 4 mg|Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272207|NCT02731742|OG000|Outcome|MK-1966 70 mg+SD-101 1 mg|Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272208|NCT02731742|OG001|Outcome|MK-1966 70 mg+SD-101 4 mg|Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272209|NCT02731742|OG002|Outcome|MK-1966 210 mg+SD-101 4 mg|Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272210|NCT02731742|OG003|Outcome|MK-1966 700 mg+SD-101 4 mg|Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272211|NCT02731742|EG000|Reported Event|MK-1966 70 mg+SD-101 1 mg|Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272212|NCT02731742|EG001|Reported Event|MK-1966 70 mg+SD-101 4 mg|Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272213|NCT02731742|EG002|Reported Event|MK-1966 210 mg+SD-101 4 mg|Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272214|NCT02731742|EG003|Reported Event|MK-1966 700 mg+SD-101 4 mg|Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
11272215|NCT02731755|BG000|Baseline|All Participant|Crossover study - All participant
11272216|NCT02731755|FG000|Participant Flow|Oat Then Control|The first intervention is oat, the second intervention is control
11272217|NCT02731755|FG001|Participant Flow|Control Then Oat|The first intervention is control, the second intervention is oat
11272218|NCT02731755|OG000|Outcome|Oat Intervention|The first intervention is oat, the second intervention is control
11272219|NCT02731755|OG001|Outcome|Control|The first intervention is control, the second intervention is oat
11272220|NCT02731755|EG000|Reported Event|Oat Intervention|Participants received oat intervention
11272221|NCT02731755|EG001|Reported Event|Control|Participants received control intervention
11337652|NCT03589885|OG001|Outcome|POST-module by Visit|POST-Module by Visit score-Entire Treatment Period (Safety Set)
10847369|NCT00282984|FG000|Participant Flow|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
10847370|NCT00282984|FG001|Participant Flow|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
10847371|NCT00282984|OG000|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
11214534|NCT02292784|OG000|Outcome|Placebo (200719 Study)|All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous [IV] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study did not require any medical interventions or study visits to an investigational site.
11214535|NCT02292784|OG001|Outcome|Atosiban (200721 Study)|All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214536|NCT02292784|OG002|Outcome|Retosiban (200719 and 200721 Study)|All infants and children born to women who received retosiban (6 mg IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214537|NCT02292784|EG000|Reported Event|Placebo (200719 Study)|All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous [IV] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study did not require any medical interventions or study visits to an investigational site.
11214538|NCT02292784|EG001|Reported Event|Atosiban (200721 Study)|All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214539|NCT02292784|EG002|Reported Event|Retosiban (200719 and 200721 Study)|All infants and children born to women who received retosiban (6 mg IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
11214540|NCT02292849|BG000|Baseline|Peer to Peer Coaches|These individuals were eligible to provide the Behavioral Activation intervention.
11214541|NCT02292849|BG001|Baseline|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
11214542|NCT02292849|BG002|Baseline|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
11214543|NCT02292849|BG003|Baseline|Total|Total of all reporting groups
11214544|NCT02292849|FG000|Participant Flow|Peer to Peer Coaches|Peer coaches who were eligible to provide the Behavioral Activation intervention
11214545|NCT02292849|FG001|Participant Flow|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
11214546|NCT02292849|FG002|Participant Flow|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
11214547|NCT02292849|OG000|Outcome|Peer to Peer Coaches|Peer coaches who were eligible to provide the Behavioral Activation intervention
11214548|NCT02292849|OG000|Outcome|Peer to Peer Clients|Those individuals will receive a standard mental health referral to a community agency and in addition meet with a Peer Coach for 12 weekly meetings.
11214549|NCT02292849|OG000|Outcome|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
11214550|NCT02292849|OG001|Outcome|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
11214551|NCT02292849|EG000|Reported Event|Peer to Peer Clients|"These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings.~Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation"
11214552|NCT02292849|EG001|Reported Event|Referral Clients|"These individuals will receive a standard mental health referral to a community agency.~Standard Mental Health Referral: Standard mental health referral to a community agency"
11214553|NCT02292927|BG000|Baseline|Baseline Pre|Baseline Characteristics of the Pre-intervention Standard of Care
11214554|NCT02292927|BG001|Baseline|Baseline Post|Baseline Characteristics of the Post-intervention Prehabilitation
11214555|NCT02292927|BG002|Baseline|Total|Total of all reporting groups
11214556|NCT02292927|FG000|Participant Flow|Pre-intervention|Patients treated as standard before intervention
11214557|NCT02292927|FG001|Participant Flow|Post-intervention|"Patients after the institution of a physical, psychological and social training programme~Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice"
11214558|NCT02292927|OG000|Outcome|Post-intervention|"Patients after the institution of a physical, psychological and social training programme~Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice"
11214559|NCT02292927|OG001|Outcome|Pre-intervention|Before the introduction of a rehabilitation programme
11272222|NCT02731820|BG000|Baseline|Treatment Group, Potassium Citrate|"Potassium citrate Calcium carbonate Vitamin D3~Potassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272223|NCT02731820|BG001|Baseline|Control Group, Placebo|"Placebo (Excipients) Calcium carbonate Vitamin D3~Placebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272224|NCT02731820|BG002|Baseline|Total|Total of all reporting groups
10847372|NCT00282984|OG001|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
11214560|NCT02292927|OG001|Outcome|Pre-intervention|Before the institution of a rehabilitation programme
11214561|NCT02292927|OG000|Outcome|Pre-intervention|Patients treated as standard before intervention
11214562|NCT02292927|OG001|Outcome|Post-intervention|"Patients after the institution of a physical, psychological and social training programme~Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice = 13"
11214563|NCT02292927|EG000|Reported Event|Post-intervention|"Patients after the institution of a physical, psychological and social training programme~Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice"
11214564|NCT02292927|EG001|Reported Event|Pre-intervention|Before the institution of a physical, psychological and social training programme
11214565|NCT02292940|BG000|Baseline|Adult Patients With Chronic Conditions: Medical Record Data|Medical record data of adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system.
11214566|NCT02292940|BG001|Baseline|Adult Patients With Chronic Conditions Survey Data|Survey data competed by adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system. Participants were given the option to complete the survey by mail, by phone with a research assistant, or online
11214567|NCT02292940|BG002|Baseline|Total|Total of all reporting groups
11214568|NCT02292940|FG000|Participant Flow|Adult Patients With Chronic Conditions: Medical Record Data|Medical record data of adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system.
11214569|NCT02292940|FG001|Participant Flow|Adult Patients With Chronic Conditions: Survey Data|Survey data completed by adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system. Participants were given the option to complete the survey by mail, by phone with a research assistant, or online.
11214570|NCT02292940|OG000|Outcome|ACSC Hospitalizations for Those Accessing the Portal|ACSC Hospitalizations for those accessing the portal.
11214571|NCT02292940|OG001|Outcome|ACSC Hospitalizations - Non Portal Users.|ACSC Hospitalizations for those who did not access the portal.
11214572|NCT02292940|OG000|Outcome|Survey Data: Portal Users|Adult patients with complex chronic conditions who registered to use the portal completed a survey describing reasons for using the portal.
11214573|NCT02292940|EG000|Reported Event|Adult Patients With Complex Chronic Conditions|Adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system.
11214574|NCT02292940|EG001|Reported Event|Adult Patients With Complex Chronic Conditions: Survey Data|Survey data completed by adult patients with diabetes and/or complex chronic conditions in a large integrated delivery system. Participants were given the option to complete the survey by mail, by phone with a research assistant or online.
11214575|NCT02293044|BG000|Baseline|Crest® Sensi-Stop™ Strips|"Self Applied~Crest® Sensi-Stop™ Strips"
11214576|NCT02293044|FG000|Participant Flow|Crest® Sensi-Stop™ Strips|"Self Applied~Crest® Sensi-Stop™ Strips"
11214577|NCT02293044|OG000|Outcome|Crest® Sensi-Stop™ Strips|"Self Applied~Crest® Sensi-Stop™ Strips"
11214578|NCT02293044|EG000|Reported Event|Crest® Sensi-Stop™ Strips|"Self Applied~Crest® Sensi-Stop™ Strips"
11214579|NCT02293096|BG000|Baseline|Metoprolol Succinate, Genotyping, Clinical Factors, and Phenotyping|"The parent study will integrate covariates to predict metoprolol effectiveness for SBP decline of 10%. All patients will receive metoprolol. The following covariates will be used to predict metoprolol effectiveness: clinical variables (Age, sex, race/ethnicity, co-medications, and BMI) CYP2D6 genotype, CYP2D6 phenotype, and metabolomic factors.~metoprolol succinate~Genotyping: CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete.~CYP2D6 Phenotyping: Phenotype can be discordant from what is predicted by genotype. CYP2D6 henotyping using dextromethorphan will be used. Investigators will be blind to the patient blood pressure outcome for this intervention."
11214580|NCT02293096|FG000|Participant Flow|Metoprolol Succinate, Genotyping, Clinical Factors, and Phenotyping|"The parent study will integrate covariates to predict metoprolol effectiveness for SBP decline of 10%. All patients will receive metoprolol. The following covariates will be used to predict metoprolol effectiveness: clinical variables (Age, sex, race/ethnicity, co-medications, and BMI) CYP2D6 genotype, CYP2D6 phenotype, and metabolomic factors.~metoprolol succinate~Genotyping: CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete.~CYP2D6 Phenotyping: Phenotype can be discordant from what is predicted by genotype. CYP2D6 henotyping using dextromethorphan will be used. Investigators will be blind to the patient blood pressure outcome for this intervention."
11272225|NCT02731820|FG000|Participant Flow|Treatment Group, Potassium Citrate|"Potassium citrate Calcium carbonate Vitamin D3~Potassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272226|NCT02731820|FG001|Participant Flow|Control Group, Placebo|"Placebo (Excipients) Calcium carbonate Vitamin D3~Placebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272227|NCT02731820|OG000|Outcome|Treatment Group, Potassium Citrate|"Potassium citrate Calcium carbonate Vitamin D3~Potassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272228|NCT02731820|OG001|Outcome|Control Group, Placebo|"Placebo (Excipients) Calcium carbonate Vitamin D3~Placebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272229|NCT02731820|EG000|Reported Event|Treatment Group|"Potassium citrate Calcium carbonate Vitamin D3~Potassium citrate: Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272230|NCT02731820|EG001|Reported Event|Control Group, Placebo|"Placebo (Excipients) Calcium carbonate Vitamin D3~Placebo: Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)~Vitamin D3: 400 IU/die Vitamin D3 daily by mouth~Calcium carbonate: 500 mg/die calcium carbonate daily by mouth"
11272231|NCT02731833|BG000|Baseline|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272232|NCT02731833|BG001|Baseline|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272233|NCT02731833|BG002|Baseline|Total|Total of all reporting groups
11272234|NCT02731833|FG000|Participant Flow|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272235|NCT02731833|FG001|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272236|NCT02731833|OG000|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272237|NCT02731833|OG001|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272238|NCT02731833|EG000|Reported Event|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272239|NCT02731833|EG001|Reported Event|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11272240|NCT02732015|BG000|Baseline|Cohort 1 - 8mg Dexamethasone|Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
11272241|NCT02732015|BG001|Baseline|Cohort 2- 12mg Dexamethasone|Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
11272242|NCT02732015|BG002|Baseline|Total|Total of all reporting groups
11272243|NCT02732015|FG000|Participant Flow|Cohort 1|Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
11272244|NCT02732015|FG001|Participant Flow|Cohort 2|Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
11272245|NCT02732015|OG000|Outcome|Cohort 1|Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
11272246|NCT02732015|OG001|Outcome|Cohort 2|Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
11272247|NCT02732015|EG000|Reported Event|Cohort 1|Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
11272248|NCT02732015|EG001|Reported Event|Cohort 2|Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
11272249|NCT02732119|BG000|Baseline|Cohort A|Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
11272250|NCT02732119|BG001|Baseline|Cohort B|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272251|NCT02732119|BG002|Baseline|Cohort C|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272252|NCT02732119|BG003|Baseline|Group 1|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272253|NCT02732119|BG004|Baseline|Group 2|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272254|NCT02732119|BG005|Baseline|Total|Total of all reporting groups
11272255|NCT02732119|FG000|Participant Flow|Cohort A|Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
11272256|NCT02732119|FG001|Participant Flow|Cohort B|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272257|NCT02732119|FG002|Participant Flow|Cohort C|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272258|NCT02732119|FG003|Participant Flow|Group 1|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272259|NCT02732119|FG004|Participant Flow|Group 2|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272260|NCT02732119|OG000|Outcome|Cohort A|Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
11272261|NCT02732119|OG001|Outcome|Cohort B|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272262|NCT02732119|OG002|Outcome|Cohort C|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272263|NCT02732119|OG000|Outcome|Group 1|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272264|NCT02732119|OG001|Outcome|Group 2|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272265|NCT02732119|EG000|Reported Event|Cohort A|Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
11272266|NCT02732119|EG001|Reported Event|Cohort B|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272267|NCT02732119|EG002|Reported Event|Cohort C|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken ora
11272268|NCT02732119|EG003|Reported Event|Group 1|Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
11272269|NCT02732119|EG004|Reported Event|Group 2|Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
11272270|NCT02732145|BG000|Baseline|Normal Vulva|Patients without vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and finding any vulvar lesion (Clinical Examination and Cotton-Swab Test); undergoing planned labioplasty, who granted vulvar specimens for further investigation.
11272271|NCT02732145|BG001|Baseline|Impaired Vulvar Skin|Patients without vulvar symptoms (ISSVD Vulvodynia Pattern Questionnaire), but with some non-specific vulvar lesions (Clinical Examination and Cotton-Swab Test); undergoing planned labioplasty, who granted vulvar specimens for further investigation.
11272272|NCT02732145|BG002|Baseline|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), who clinically fulfilled Friedrich's criteria (Clinical Examination and Cotton-Swab Test). Non-specific lesions found with TRIV were not relevant for the diagnosis of vulvodynia.
11272273|NCT02732145|BG003|Baseline|Vulvar Dermatosis|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and vulvar lesions specific for dermatosis (Clinical Examination and Cotton-Swab Test).
11272274|NCT02732145|BG004|Baseline|Total|Total of all reporting groups
11272275|NCT02732145|FG000|Participant Flow|Normal Vulva|Patients without vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and finding any vulvar lesion (Clinical Examination and Cotton-Swab Test); undergoing planned labioplasty, who granted vulvar specimens for further investigation.
11272276|NCT02732145|FG001|Participant Flow|Impaired Vulvar Skin|Patients without vulvar symptoms (ISSVD Vulvodynia Pattern Questionnaire), but with some non-specific vulvar lesions (Clinical Examination and Cotton-Swab Test); undergoing planned labioplasty, who granted vulvar specimens for further investigation.
11272277|NCT02732145|FG002|Participant Flow|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), who clinically fulfilled Friedrich's criteria (Clinical Examination and Cotton-Swab Test). Non-specific lesions found with TRIV were not relevant for the diagnosis of vulvodynia.
11272278|NCT02732145|FG003|Participant Flow|Vulvar Dermatosis|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and vulvar lesions specific for dermatosis (Clinical Examination and Cotton-Swab Test).
11272279|NCT02732145|OG000|Outcome|Vulvoscopy: Vulvar Dermatosis|"Patients with vulvoscopy diagnosis Vulvar Dermatosis according to the Vulvoscopy Index (19-32 points)."
11272280|NCT02732145|OG001|Outcome|Vulvoscopy: Absent Vulvar Dermatosis|"Patients with vulvoscopy diagnoses Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points) and Vulvodynia (12-18 points) according to the Vulvoscopy Index, who were classified into one group labeled by the term Absent Vulvar Dermatosis."
11272281|NCT02732145|OG001|Outcome|Histopathology: Vulvar Dermatosis|"Histopathological diagnosis Vulvar Dermatosis from the vulvar specimens of 328 women was set in 72 patients."
11272282|NCT02732145|OG000|Outcome|Vulvoscopy: Absent Vulvar Dermatosis|"Patients with vulvoscopy diagnoses Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points) and Vulvodynia (12-18 points) according to the Vulvoscopy Index, who were classified into one group labeled by the term Absent Vulvar Dermatosis."
11272283|NCT02732145|OG001|Outcome|Histopathology: Absent Vulvar Dermatosis|"Histopathological diagnosis Normal Vulva or absent vulvar dermatosis."
11272284|NCT02732145|OG001|Outcome|Histopathology: Absent Vulvar Dermatosis|"Histopathological diagnosis: Normal Vulva or absent vulvar dermatosis."
11272285|NCT02732145|OG000|Outcome|Vulvoscopy: Absent Vulvar Dermatosis|"Patients with vulvoscopy diagnoses: Normal Vulva, Impaired Vulvar Skin and Vulvodynia according to the N-S-P Scheme, who were classified into one group marked by the term Absent Vulvar Dermatosis."
11272286|NCT02732145|OG000|Outcome|Normal Vulva|Patients without vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and without finding any clinical and colposcopy vulvar lesion.
11272287|NCT02732145|OG001|Outcome|Impaired Vulvar Skin|Patients without vulvar symptoms (ISSVD Vulvodynia Pattern Questionnaire) but with some non-specific vulvar lesions found clinically and with TRIV.
11272288|NCT02732145|OG002|Outcome|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), who clinically fulfilled Friedrich's criteria. Non-specific lesions found with TRIV were not relevant for diagnosis of vulvodynia.
11272289|NCT02732145|OG003|Outcome|Vulvar Dermatosis|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), clinical and vulvoscopy (TRIV) finding of lesions specific for dermatosis.
11272290|NCT02732145|OG000|Outcome|Normal Vulva|Patients without vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) and without finding of any clinical and colposcopy vulvar lesion.
11272291|NCT02732145|OG000|Outcome|Vulvar Dermatosis|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), clinical and vulvoscopy (TRIV) finding of lesions specific for dermatosis.
11272292|NCT02732145|OG001|Outcome|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire) who clinically fulfilled Friedrich's criteria. Non-specific lesions found with TRIV were not relevant for diagnosis of vulvodynia.
11272293|NCT02732145|OG002|Outcome|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), who clinically fulfilled Friedrich's criteria. Non-specific lesions found with TRIV (some non-specific lesions of the vulva) were not relevant for diagnosis of vulvodynia.
11272294|NCT02732145|OG001|Outcome|Vulvodynia|Patients with vulvar discomfort (ISSVD Vulvodynia Pattern Questionnaire), who clinically fulfilled Friedrich's criteria. Non-specific lesions found with TRIV were not relevant for diagnosis of vulvodynia.
11272295|NCT02732145|OG000|Outcome|Vulvar Dermatosis With Normal Epidermis|Histopathological Finding of Normal Epidermis among the various vulvar complaints in patients with vulvar dermatosis.
11272296|NCT02732145|OG001|Outcome|Vulvar Dermatosis With Abnormal Epidermis|Histopathological Finding of Abnormal Epidermis among the various vulvar complaints in patients with vulvar dermatosis.
11272297|NCT02732145|OG000|Outcome|Vulvodynia With Normal Epidermis|Histopathological Finding of Normal Epidermis among the various vulvar complaints in patients with vulvodynia.
11272298|NCT02732145|OG001|Outcome|Vulvodynia With Abnormal Epidermis|Histopathological Finding of Abnormal Epidermis among the various vulvar complaints in patients with vulvodynia.
11272299|NCT02732145|OG000|Outcome|Vulvar Dermatosis 1|Patients with duration of symptoms of the vulvar dermatosis less than 24 months.
11272300|NCT02732145|OG001|Outcome|Vulvar Dermatosis 2|Patients with duration of symptoms of the vulvar dermatosis more than 24 months.
11272301|NCT02732145|OG000|Outcome|Vulvodynia 1|Patients with duration of symptoms of the vulvodynia less than 24 months.
11272302|NCT02732145|OG001|Outcome|Vulvodynia 2|Patients with duration of symptoms of vulvodynia more than 24 months.
11272303|NCT02732145|EG000|Reported Event|Normal Vulva|Patients without vulvar discomfort and any vulvar lesion undergoing planned labioplasty, before surgery.
11272304|NCT02732145|EG001|Reported Event|Impaired Vulvar Skin|Patients without vulvar symptoms with some non-specific lesions of the vulva found by clinical examination, undergoing planned labioplasty, before surgery.
11272305|NCT02732145|EG002|Reported Event|Vulvodynia|Patients with vulvar discomfort, who clinically fulfilled Friedrich's criteria. Non-specific lesions found with TRIV were not relevant to the diagnosis of vulvodynia.
11272306|NCT02732145|EG003|Reported Event|Vulvar Dermatosis|Patients with vulvar discomfort and vulvar lesions specific for dermatosis found by clinical examination.
11272307|NCT02732210|BG000|Baseline|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
11272308|NCT02732210|BG001|Baseline|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
11272309|NCT02732210|BG002|Baseline|Total|Total of all reporting groups
11272310|NCT02732210|FG000|Participant Flow|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
11272311|NCT02732210|FG001|Participant Flow|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
11272312|NCT02732210|OG000|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
11272313|NCT02732210|OG001|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
11272314|NCT02732210|EG000|Reported Event|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
11272315|NCT02732210|EG001|Reported Event|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
11272316|NCT02732366|BG000|Baseline|Group-based Exercise and Peer Coaching|"This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.~Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring."
11272317|NCT02732366|BG001|Baseline|Usual PT and Attention Control Grp Class|"This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.~Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions)."
11272318|NCT02732366|BG002|Baseline|Total|Total of all reporting groups
11272319|NCT02732366|FG000|Participant Flow|Group-based Exercise and Peer Coaching|"This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.~Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring."
11272320|NCT02732366|FG001|Participant Flow|Usual PT and Attention Control Grp Class|"This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.~Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions)."
11272321|NCT02732366|OG000|Outcome|Screened Population|Number screened
11272322|NCT02732366|OG000|Outcome|Group-based Exercise and Peer Coaching|Attendance to 8 intervention sessions for 6 groups
11272323|NCT02732366|OG001|Outcome|Usual PT and Attention Control Grp Class|Attendance to 6 control group sessions for 6 groups
11272324|NCT02732366|OG000|Outcome|Group-based Exercise and Peer Coaching|"This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.~Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring."
11272325|NCT02732366|OG001|Outcome|Usual PT and Attention Control Grp Class|"This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.~Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions)."
11272326|NCT02732366|EG000|Reported Event|Group-based Exercise and Peer Coaching|"This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.~Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring."
11272327|NCT02732366|EG001|Reported Event|Usual PT and Attention Control Grp Class|"This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.~Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions)."
11272328|NCT02732561|BG000|Baseline|Sham Device|"Sham device~Sham device: Sham device"
11272329|NCT02732561|BG001|Baseline|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
11272330|NCT02732561|BG002|Baseline|Total|Total of all reporting groups
11272331|NCT02732561|FG000|Participant Flow|Sham Device|"Sham device~Sham device: Sham device"
11272332|NCT02732561|FG001|Participant Flow|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
11272333|NCT02732561|OG000|Outcome|Sham Device|"Sham device~Sham device: Sham device"
11272334|NCT02732561|OG001|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
11272335|NCT02732561|EG000|Reported Event|Sham Device|"Sham device~Sham device: Sham device"
11272336|NCT02732561|EG001|Reported Event|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
11337653|NCT03589885|OG002|Outcome|Absolute Change POST Module -PRE Module|Absolute Change POST Module -PRE Module scores
11272337|NCT02732587|BG000|Baseline|125 mg Saracatinib|"125 mg Saracatinib once daily for 8-11 days~Saracatinib: Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session"
11272338|NCT02732587|FG000|Participant Flow|125 mg Saracatinib|. Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
11272339|NCT02732587|OG000|Outcome|125 mg Saracatinib|Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
11272340|NCT02732587|EG000|Reported Event|125 mg Saracatinib|Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
11272341|NCT02732600|BG000|Baseline|Standard Implementation|Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
11272342|NCT02732600|BG001|Baseline|Facilitated Implementation|"Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation.~Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation"
11272343|NCT02732600|BG002|Baseline|Total|Total of all reporting groups
11272344|NCT02732600|FG000|Participant Flow|Standard Implementation|Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
11272345|NCT02732600|FG001|Participant Flow|Facilitated Implementation|"Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation.~Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation"
11272346|NCT02732600|OG000|Outcome|Standard Implementation|Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
11272347|NCT02732600|OG001|Outcome|Facilitated Implementation|"Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation.~Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation"
11272348|NCT02732600|OG000|Outcome|Standard Implementation|Standard Implementation sites will receive written guidance and limited consultation by the in vestigators' team.
11272349|NCT02732600|EG000|Reported Event|Standard Implementation|Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
11272350|NCT02732600|EG001|Reported Event|Facilitated Implementation|"Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation.~Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation"
11272351|NCT02732639|BG000|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
11272352|NCT02732639|FG000|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
11272353|NCT02732639|OG000|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
11272354|NCT02732639|EG000|Reported Event|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
11272355|NCT02732847|BG000|Baseline|Post-Dated Prescription|"a delayed prescription dated 2 days after clinical office visit~A delayed prescription dated 2 days after clinical office visit"
11272356|NCT02732847|BG001|Baseline|Usual|"usual date~Usual Dated"
11272357|NCT02732847|BG002|Baseline|Total|Total of all reporting groups
11272358|NCT02732847|FG000|Participant Flow|Post-Dated Prescription|"a delayed prescription dated 2 days after clinical office visit~A delayed prescription dated 2 days after clinical office visit"
11272359|NCT02732847|FG001|Participant Flow|Usual|"usual date~Usual Dated"
11272360|NCT02732847|OG000|Outcome|Post-Dated Prescription|"a delayed prescription dated 2 days after clinical office visit~A delayed prescription dated 2 days after clinical office visit"
11272361|NCT02732847|OG001|Outcome|Usual|"usual date~Usual Dated"
11272362|NCT02732847|EG000|Reported Event|Post-Dated Prescription|"a delayed prescription dated 2 days after clinical office visit~A delayed prescription dated 2 days after clinical office visit"
11272363|NCT02732847|EG001|Reported Event|Usual|"usual date~Usual Dated"
11272364|NCT02732899|BG000|Baseline|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
11272365|NCT02732899|BG001|Baseline|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
11272366|NCT02732899|BG002|Baseline|Total|Total of all reporting groups
11272367|NCT02732899|FG000|Participant Flow|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
11272368|NCT02732899|FG001|Participant Flow|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
11272369|NCT02732899|OG000|Outcome|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
11272370|NCT02732899|OG001|Outcome|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
11272371|NCT02732899|EG000|Reported Event|Group 1|"Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32.~Sirolimus~EYLEA"
11272372|NCT02732899|EG001|Reported Event|Group 2|"Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment~EYLEA"
11272373|NCT02732912|BG000|Baseline|Control|"Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272374|NCT02732912|BG001|Baseline|Eye Mask and Ear Plugs|"General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.~Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272375|NCT02732912|BG002|Baseline|Total|Total of all reporting groups
11272376|NCT02732912|FG000|Participant Flow|Control|"Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272377|NCT02732912|FG001|Participant Flow|Eye Mask and Ear Plugs|"General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.~Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272378|NCT02732912|OG000|Outcome|Control|"Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272379|NCT02732912|OG001|Outcome|Eye Mask and Ear Plugs|"General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.~Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11337654|NCT03589885|EG000|Reported Event|Secukinumab 300 mg (2 mL Auto-Injector)|Secukinumab 300 mg provided in 2 mL auto-injector form
11272380|NCT02732912|EG000|Reported Event|Control|"Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272381|NCT02732912|EG001|Reported Event|Eye Mask and Ear Plugs|"General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.~Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.~Zopiclone: This night sedation will be given to any patient requesting it, in either group"
11272382|NCT02732938|BG000|Baseline|Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272383|NCT02732938|BG001|Baseline|Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272384|NCT02732938|BG002|Baseline|Total|Total of all reporting groups
11272385|NCT02732938|FG000|Participant Flow|Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272386|NCT02732938|FG001|Participant Flow|Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272387|NCT02732938|FG002|Participant Flow|Phase 2: PF-04136309 or Placebo + Nab-paclitaxel + Gemcitabine|In Phase 2 part of the study which was not conducted due to early termination, participants were to be randomized with a 1:1 to receive either PF-04136309 or placebo in combination with nab-paclitaxel + gemcitabine. The dose of PF-04136309 was to be the recommended Phase 2 dose (RP2D) determined in the Phase 1b part of the study.
11272388|NCT02732938|OG000|Outcome|Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272389|NCT02732938|OG001|Outcome|Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272390|NCT02732938|OG000|Outcome|Phase 2: PF-04136309 or Placebo + Nab-paclitaxel + Gemcitabine|In Phase 2 part of the study which was not conducted due to early termination, participants were to be randomized with a 1:1 to receive either PF-04136309 or placebo in combination with nab-paclitaxel + gemcitabine. The dose of PF-04136309 was to be the recommended Phase 2 dose (RP2D) determined in the Phase 1b part of the study.
11272391|NCT02732938|OG000|Outcome|Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272392|NCT02732938|EG000|Reported Event|Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 750 mg twice-daily (BID) for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an intravenous (IV) infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272393|NCT02732938|EG001|Reported Event|Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine|PF-04136309 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. Nab-paclitaxel (125 mg/m2) was administered as an IV infusion on Days 1, 8 and 15 followed by 1 week of no treatment in 28-day cycles. Gemcitabine (1000 mg/m2) was administered as an IV infusion immediately after nab-paclitaxel, on Days 1, 8 and 15 followed by 1 week off treatment for 28-day cycles.
11272394|NCT02732951|BG000|Baseline|Placebo Matching to BI 1026706|Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
11272395|NCT02732951|BG001|Baseline|BI 1026706|Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
11272396|NCT02732951|BG002|Baseline|Total|Total of all reporting groups
11272397|NCT02732951|FG000|Participant Flow|Placebo Matching to BI 1026706|Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
11272398|NCT02732951|FG001|Participant Flow|BI 1026706|Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
11272399|NCT02732951|OG000|Outcome|Placebo Matching to BI 1026706|Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
11272400|NCT02732951|OG001|Outcome|BI 1026706|Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
11272401|NCT02732951|EG000|Reported Event|Placebo Matching to BI 1026706|Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
11272402|NCT02732951|EG001|Reported Event|BI 1026706|Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
11272403|NCT02733367|BG000|Baseline|Infacort|"Infacort® granules~Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled."
11272404|NCT02733367|FG000|Participant Flow|Infacort|"Infacort® granules~Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled."
11272405|NCT02733367|OG000|Outcome|Infacort|"Infacort® granules~Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled."
11272406|NCT02733367|OG000|Outcome|Infacort|"Infacort® granules~Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg)."
11272407|NCT02733367|EG000|Reported Event|Infacort|"Infacort® granules~Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled."
11272408|NCT02733588|BG000|Baseline|G-Pump™ (Glucagon Infusion)|"0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump~G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump"
11272409|NCT02733588|FG000|Participant Flow|G-Pump™ (Glucagon Infusion)|"0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump~G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump"
11272410|NCT02733588|OG000|Outcome|G-Pump™ (Glucagon Infusion)|"0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump~G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump"
11272411|NCT02733588|EG000|Reported Event|G-Pump™ (Glucagon Infusion)|"0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump~G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump"
11272412|NCT02733627|BG000|Baseline|BI 1467335 10 mg (Low Dose)|Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272413|NCT02733627|BG001|Baseline|BI 1467335 15 mg (Medium Dose)|Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272414|NCT02733627|BG002|Baseline|BI 1467335 20 mg (High Dose)|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272415|NCT02733627|BG003|Baseline|Placebo|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272416|NCT02733627|BG004|Baseline|Total|Total of all reporting groups
11272417|NCT02733627|FG000|Participant Flow|BI 1467335 10 mg (Low Dose)|Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272418|NCT02733627|FG001|Participant Flow|BI 1467335 15 mg (Medium Dose)|Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272419|NCT02733627|FG002|Participant Flow|BI 1467335 20 mg (High Dose)|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272420|NCT02733627|FG003|Participant Flow|Placebo|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272421|NCT02733627|OG000|Outcome|BI 1467335 10 mg (Low Dose)|Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272422|NCT02733627|OG001|Outcome|BI 1467335 15 mg (Medium Dose)|Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272423|NCT02733627|OG002|Outcome|BI 1467335 20 mg (High Dose)|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272424|NCT02733627|OG003|Outcome|Placebo|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272425|NCT02733627|EG000|Reported Event|Placebo|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272426|NCT02733627|EG001|Reported Event|BI 1467335 10 mg (Low Dose)|Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11337655|NCT03589885|EG001|Reported Event|Secukinumab 300 mg (2 x 1 mL PFS)|Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
11272427|NCT02733627|EG002|Reported Event|BI 1467335 15 mg (Medium Dose)|Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272428|NCT02733627|EG003|Reported Event|BI 1467335 20 mg (High Dose)|Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
11272429|NCT02733653|BG000|Baseline|Jetstream Atherectomy System - Primary Subject|"Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention~Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA"
11272430|NCT02733653|FG000|Participant Flow|Jetstream Atherectomy System - Primary Subject|"Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention~Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA"
11272431|NCT02733653|OG000|Outcome|Jetstream Atherectomy System - Primary Subject|"Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention~Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA"
11272432|NCT02733653|EG000|Reported Event|Jetstream Atherectomy System - Primary Subject|"Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention~Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA"
11272433|NCT02733757|BG000|Baseline|Sub-Tenon's Group Control|2% Lidocaine without epinephrine
11272434|NCT02733757|BG001|Baseline|Sub-Tenon's Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272435|NCT02733757|BG002|Baseline|Peribulbar Group Control|2% Lidocaine without epinephrine
11272436|NCT02733757|BG003|Baseline|Peribulbar Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272437|NCT02733757|BG004|Baseline|Total|Total of all reporting groups
11272438|NCT02733757|FG000|Participant Flow|Sub-Tenon's Group Control|2% Lidocaine without epinephrine
11272439|NCT02733757|FG001|Participant Flow|Sub-Tenon's Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272440|NCT02733757|FG002|Participant Flow|Peribulbar Group Control|2% Lidocaine without epinephrine
11272441|NCT02733757|FG003|Participant Flow|Peribulbar Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272442|NCT02733757|OG000|Outcome|Sub-Tenon's Group Control|2% Lidocaine without epinephrine
11272443|NCT02733757|OG001|Outcome|Sub-Tenon's Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272444|NCT02733757|OG002|Outcome|Peribulbar Group Control|2% Lidocaine without epinephrine
11272445|NCT02733757|OG003|Outcome|Peribulbar Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272446|NCT02733757|EG000|Reported Event|Sub-Tenon's Group Control|2% Lidocaine without epinephrine
11272447|NCT02733757|EG001|Reported Event|Sub-Tenon's Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272448|NCT02733757|EG002|Reported Event|Peribulbar Group Control|2% Lidocaine without epinephrine
11272449|NCT02733757|EG003|Reported Event|Peribulbar Group Clonidine|"2% Lidocaine without epinephrine plus clonidine 1 µg/kg~Clonidine: Clonidine 1 µg/kg plus 2% lidocaine"
11272450|NCT02733991|BG000|Baseline|Treatment|MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
11272451|NCT02733991|BG001|Baseline|Control|MiniMed™640G alone
11272452|NCT02733991|BG002|Baseline|Total|Total of all reporting groups
11272453|NCT02733991|FG000|Participant Flow|Treatment|MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
11272454|NCT02733991|FG001|Participant Flow|Control|MiniMed™640G alone
11272455|NCT02733991|OG000|Outcome|Treatment|MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
11272456|NCT02733991|OG001|Outcome|Control|MiniMed™640G alone
11272457|NCT02733991|EG000|Reported Event|Treatment|MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
11272458|NCT02733991|EG001|Reported Event|Control|MiniMed™640G alone
11272459|NCT02734056|BG000|Baseline|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
11272460|NCT02734056|BG001|Baseline|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
11272461|NCT02734056|BG002|Baseline|Total|Total of all reporting groups
11272462|NCT02734056|FG000|Participant Flow|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
11272463|NCT02734056|FG001|Participant Flow|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
11272464|NCT02734056|OG000|Outcome|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
11272465|NCT02734056|OG001|Outcome|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
11272466|NCT02734056|EG000|Reported Event|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
11272467|NCT02734056|EG001|Reported Event|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
11272468|NCT02734147|BG000|Baseline|High Dose IV Ascorbic Acid|"Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.~Ascorbic Acid"
11272469|NCT02734147|BG001|Baseline|Placebo|"The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.~Normal Saline"
11272470|NCT02734147|BG002|Baseline|Total|Total of all reporting groups
11272471|NCT02734147|FG000|Participant Flow|High Dose IV Ascorbic Acid|"Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.~Ascorbic Acid~Participant Started: 12 Participant Completed: 9"
11272472|NCT02734147|FG001|Participant Flow|Placebo|"The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.~Normal Saline~Participant Started: 12 Participant Completed: 11"
11272473|NCT02734147|OG000|Outcome|High Dose IV Ascorbic Acid|"Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.~Ascorbic Acid"
11272474|NCT02734147|OG001|Outcome|Placebo|"The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.~Normal Saline"
11272475|NCT02734147|EG000|Reported Event|High Dose IV Ascorbic Acid|"Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.~Ascorbic Acid"
11272476|NCT02734147|EG001|Reported Event|Placebo|"The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.~Normal Saline"
11272477|NCT02734212|BG000|Baseline|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11272478|NCT02734212|BG001|Baseline|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
11272479|NCT02734212|BG002|Baseline|Total|Total of all reporting groups
11272480|NCT02734212|FG000|Participant Flow|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11272481|NCT02734212|FG001|Participant Flow|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
11272482|NCT02734212|OG000|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11272483|NCT02734212|OG001|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
11272484|NCT02734212|OG001|Outcome|Enhanced Treatment as Usual|"The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.~."
11272485|NCT02734212|EG000|Reported Event|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
11272486|NCT02734212|EG001|Reported Event|Enhanced Treatment as Usual|"The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.~."
11272487|NCT02734238|BG000|Baseline|Energy Deficit|"Participants randomly assigned to the control condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered sesame oil placebo injections during phase 2 of the trial.~Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35"
11272488|NCT02734238|BG001|Baseline|Energy Deficit + Testosterone|"Participants randomly assigned to the intervention condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered testosterone enanthate injections during phase 2 of the trial.~testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35"
11272489|NCT02734238|BG002|Baseline|Total|Total of all reporting groups
11272490|NCT02734238|FG000|Participant Flow|Energy Deficit|"Participants randomly assigned to the control condition were subjected to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered sesame oil placebo injections during phase 2 of the trial.~Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35"
11272491|NCT02734238|FG001|Participant Flow|Energy Deficit + Testosterone|"Participants randomly assigned to the intervention condition were subjected to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered testosterone enanthate injections during phase 2 of the trial.~testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35"
11337656|NCT03589885|EG002|Reported Event|Any Secukinumab 300 mg (2 mL AI)|Any Secukinumab 300 mg (2 mL AI)
11337657|NCT03589885|EG003|Reported Event|Any Secukinumab 300 mg (2 x 1 mL PFS)|Any Secukinumab 300 mg (2 x 1 mL PFS)
11272492|NCT02734238|OG000|Outcome|Energy Deficit|"Participants randomly assigned to the control condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered sesame oil placebo injections during phase 2 of the trial.~Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35"
11272493|NCT02734238|OG001|Outcome|Energy Deficit + Testosterone|"Participants randomly assigned to the intervention condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered testosterone enanthate injections during phase 2 of the trial.~testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35"
11272494|NCT02734238|EG000|Reported Event|Energy Deficit|"Participants randomly assigned to the control condition were subject to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered sesame oil placebo injections during phase 2 of the trial.~Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35"
11272495|NCT02734238|EG001|Reported Event|Energy Deficit + Testosterone|"Participants randomly assigned to the intervention condition were subject to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered testosterone enanthate injections during phase 2 of the trial.~testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35"
11272496|NCT02734355|BG000|Baseline|Therapy|"Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days~Telmisartan 80 mg and amlodipine 5 mg"
11272497|NCT02734355|BG001|Baseline|Placebo|"Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days~Placebo (for telmisartan and amlodipine): Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet"
11272498|NCT02734355|BG002|Baseline|Total|Total of all reporting groups
11272499|NCT02734355|FG000|Participant Flow|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
11272500|NCT02734355|FG001|Participant Flow|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
11272501|NCT02734355|OG000|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
11272502|NCT02734355|OG001|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
11272503|NCT02734355|EG000|Reported Event|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
11272504|NCT02734355|EG001|Reported Event|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
11272505|NCT02734498|BG000|Baseline|Right Unilateral (RUL) ECT|"Right Unilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272506|NCT02734498|BG001|Baseline|Bilateral (BL) ECT|"Bilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272507|NCT02734498|BG002|Baseline|Control Group|No ECT treatment for control group.
11272508|NCT02734498|BG003|Baseline|Total|Total of all reporting groups
11272509|NCT02734498|FG000|Participant Flow|Right Unilateral (RUL) ECT|"Right Unilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272510|NCT02734498|FG001|Participant Flow|Bilateral (BL) ECT|"Bilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272511|NCT02734498|FG002|Participant Flow|Control Group|No ECT treatment for control group.
11272512|NCT02734498|OG000|Outcome|Right Unilateral (RUL) ECT|"Right Unilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272513|NCT02734498|OG001|Outcome|Bilateral (BL) ECT|"Bilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272514|NCT02734498|OG002|Outcome|Control Group|No ECT treatment for control group.
11272515|NCT02734498|EG000|Reported Event|Right Unilateral (RUL) ECT|"Right Unilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272516|NCT02734498|EG001|Reported Event|Bilateral (BL) ECT|"Bilateral placement of treatment electrodes in electroconvulsive treatment.~Electroconvulsive Treatment (ECT): Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia"
11272517|NCT02734498|EG002|Reported Event|Control Group|No ECT treatment for control group.
11272518|NCT02734576|BG000|Baseline|Venous Sinus Stenting|Venous sinus stenting is the experimental procedure being tested in this protocol and consists of placing a stent into the narrowed veins of the brain.
11272519|NCT02734576|FG000|Participant Flow|Venous Sinus Stenting|Venous sinus stenting is the experimental procedure being tested in this protocol and consists of placing a stent into the narrowed veins of the brain.
11272520|NCT02734576|OG000|Outcome|Venous Sinus Stenting|Venous sinus stenting is the experimental procedure being tested in this protocol and consists of placing a stent into the narrowed veins of the brain.
11272521|NCT02734576|EG000|Reported Event|Venous Sinus Stenting|Venous sinus stenting is the experimental procedure being tested in this protocol and consists of placing a stent into the narrowed veins of the brain.
11272522|NCT02734693|BG000|Baseline|Placebo|Placebo capsule
11272523|NCT02734693|BG001|Baseline|Dasotraline 4mg|Dasotraline capsule 4mg/day
11272524|NCT02734693|BG002|Baseline|Dasotraline 6mg|Dasotraline capsule 6mg/day
11272525|NCT02734693|BG003|Baseline|Total|Total of all reporting groups
11272526|NCT02734693|FG000|Participant Flow|Placebo|Placebo capsule
11272527|NCT02734693|FG001|Participant Flow|Dasotraline 4mg|Dasotraline capsule 4mg/day
11272528|NCT02734693|FG002|Participant Flow|Dasotraline 6mg|Dasotraline capsule 6mg/day
11272529|NCT02734693|OG000|Outcome|Placebo|Placebo capsule
11272530|NCT02734693|OG001|Outcome|Dasotraline 4mg|Dasotraline capsule 4mg/day
11272531|NCT02734693|OG002|Outcome|Dasotraline 6mg|Dasotraline capsule 6mg/day
11272532|NCT02734693|EG000|Reported Event|Placebo|Placebo capsule
11272533|NCT02734693|EG001|Reported Event|Dasotraline 4mg|Dasotraline capsule 4mg/day
11272534|NCT02734693|EG002|Reported Event|Dasotraline 6mg|Dasotraline capsule 6mg/day
11272535|NCT02734810|BG000|Baseline|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272536|NCT02734810|BG001|Baseline|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272537|NCT02734810|BG002|Baseline|Total|Total of all reporting groups
11272538|NCT02734810|FG000|Participant Flow|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272539|NCT02734810|FG001|Participant Flow|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272540|NCT02734810|OG000|Outcome|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272541|NCT02734810|OG001|Outcome|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272542|NCT02734810|EG000|Reported Event|Part A|"Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272543|NCT02734810|EG001|Reported Event|Part B|"Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years~Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy"
11272544|NCT02734849|BG000|Baseline|25 mg AK001|25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272545|NCT02734849|BG001|Baseline|250 mg AK001|250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272546|NCT02734849|BG002|Baseline|Placebo|Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272547|NCT02734849|BG003|Baseline|Total|Total of all reporting groups
11272548|NCT02734849|FG000|Participant Flow|25 mg AK001|25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272549|NCT02734849|FG001|Participant Flow|250 mg AK001|250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272550|NCT02734849|FG002|Participant Flow|Placebo|Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272551|NCT02734849|OG000|Outcome|25 mg AK001|25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272552|NCT02734849|OG001|Outcome|250 mg AK001|250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49
11272553|NCT02734849|OG002|Outcome|Placebo|Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272554|NCT02734849|EG000|Reported Event|25 mg AK001|25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272555|NCT02734849|EG001|Reported Event|250 mg AK001|250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272556|NCT02734849|EG002|Reported Event|Placebo|Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
11272557|NCT02734862|BG000|Baseline|Group 1|"Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272558|NCT02734862|BG001|Baseline|Group 2|"Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272559|NCT02734862|BG002|Baseline|Group 3|"Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia).~After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.~Caspofungin: Intravenous antifungal therapy~Fluconazole: oral antifungal therapy~intravenous placebo: normal saline"
11272560|NCT02734862|BG003|Baseline|Total|Total of all reporting groups
11337658|NCT03589885|EG004|Reported Event|Placebo|Placebo to Secukinumab sub-cutaneous form
11337659|NCT03589885|EG005|Reported Event|Any Secukinumab 300 mg|Any Secukinumab 300 mg
11337660|NCT03590613|BG000|Baseline|All Study Participants|All study participants received GSK2982772 and PBO in four treatment sequences (A,B,C &D) at 0 hour (starting dose), 7 hours (second dose) and 14 hours (third dose) on Day 1 in each TP.
11272561|NCT02734862|FG000|Participant Flow|Group 1|"Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272562|NCT02734862|FG001|Participant Flow|Group 2|"Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272563|NCT02734862|FG002|Participant Flow|Group 3|"Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia).~After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.~Caspofungin: Intravenous antifungal therapy~Fluconazole: oral antifungal therapy~intravenous placebo: normal saline"
11272564|NCT02734862|OG000|Outcome|Group 1|"Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272565|NCT02734862|OG001|Outcome|Group 2|"Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272566|NCT02734862|OG002|Outcome|Group 3|"Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia).~After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.~Caspofungin: Intravenous antifungal therapy~Fluconazole: oral antifungal therapy~intravenous placebo: normal saline"
11272567|NCT02734862|OG001|Outcome|Group 2|"Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272568|NCT02734862|EG000|Reported Event|Group 1|"Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272569|NCT02734862|EG001|Reported Event|Group 2|"Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed.~Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.~CD101: Intravenous antifungal therapy~intravenous placebo: normal saline~oral placebo: microcrystalline cellulose"
11272570|NCT02734862|EG002|Reported Event|Group 3|"Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia).~After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.~Caspofungin: Intravenous antifungal therapy~Fluconazole: oral antifungal therapy~intravenous placebo: normal saline"
11272571|NCT02734953|BG000|Baseline|Intervention|"Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr~Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test"
11272572|NCT02734953|FG000|Participant Flow|Intervention|"Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr~Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test"
11272573|NCT02734953|OG000|Outcome|Intervention|"Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr~Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test"
11272574|NCT02734953|EG000|Reported Event|Intervention|"Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr~Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test"
11272575|NCT02734979|BG000|Baseline|Biobridge and Lymph Node Transfer|"The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.~Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery"
11272576|NCT02734979|FG000|Participant Flow|Biobridge and Lymph Node Transfer|"The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.~Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery"
11272577|NCT02734979|OG000|Outcome|Biobridge and Lymph Node Transfer|"The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.~Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery"
11272578|NCT02734979|OG000|Outcome|Caliper Skin-fold Thickness - Upper Arm|Caliper skin-fold thickness as measured at the upper arm, of the arm receiving the BioBridge implant.
11272579|NCT02734979|OG001|Outcome|Caliper Skin-fold Thickness - Forearm|Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.
11272580|NCT02734979|OG002|Outcome|Caliper Skin-fold Thickness - Hand|Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.
11272581|NCT02734979|OG000|Outcome|LYMQOL Survey - Overall QoL|LYMQOL Survey for overall quality of life (QoL) after receiving the BioBridge implant. Survey is a 10-point scale.
11272582|NCT02734979|OG001|Outcome|LYMQOL Survey - Function|LYMQOL Survey for function in the arm receiving the BioBridge implant. Survey is a 4-point scale.
11272583|NCT02734979|OG002|Outcome|LYMQOL Survey - Appearance|LYMQOL survey for appearance of the arm receiving the BioBridge implant. Survey is a 4-point scale.
11272584|NCT02734979|OG003|Outcome|LYMQOL Survey - Symptoms|LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.
11272585|NCT02734979|OG004|Outcome|LYMQOL Survey - Mood|LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
11272586|NCT02734979|EG000|Reported Event|Biobridge and Lymph Node Transfer|"The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.~Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery"
11272587|NCT02735096|BG000|Baseline|Patients Diagnosed With Vestibular Dysfunction|"Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.~EquiCue (Intraoral Electronic Balance Aid): When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement."
11272588|NCT02735096|FG000|Participant Flow|Patients Diagnosed With Vestibular Dysfunction|"Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.~EquiCue (Intraoral Electronic Balance Aid): When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement."
11272589|NCT02735096|OG000|Outcome|Patients Diagnosed With Vestibular Dysfunction|"Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.~EquiCue (Intraoral Electronic Balance Aid): When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement."
11272590|NCT02735096|EG000|Reported Event|Patients Diagnosed With Vestibular Dysfunction|"Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.~EquiCue (Intraoral Electronic Balance Aid): When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement."
11092300|NCT01539070|OG000|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
11272591|NCT02735174|BG000|Baseline|Single Arm Asthma Self-management|"Interventions include:~Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits~Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.~App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.~Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills~Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control."
11272592|NCT02735174|FG000|Participant Flow|Single Arm Asthma Self-management|"Interventions include:~Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits~Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.~App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.~Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills~Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control."
11272593|NCT02735174|OG000|Outcome|Single Arm Asthma Self-management|"Interventions include:~Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits~Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.~App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.~Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills~Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control."
10970205|NCT00909363|EG000|Reported Event|Promacta|"Promacta® is commercially available in 12.5 mg, 25 mg, 50 mg, and 75 mg tablets. For this study, for young children unable to swallow a tablet, eltrombopag powder for oral suspension (Eltrombopag PfOS) will be used. PfOS is only available for investigational use at 20mg. Each sachet contains eltrombopag equivalent to 20mg per gm of powder and is reconstituted to a total of 10 ml so that the concentration is 2 mg/ml.~Promacta (eltrombopag): WAS Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP.~Eltrombopag/promacta: Patients will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP."
10970206|NCT00909363|EG001|Reported Event|Healthy Volunteers|8 normal subjects will be studied for degree of platelet activation from one blood draw by collaborator Alan Michelson at Boston Childrens Hospital
10970207|NCT00909363|EG002|Reported Event|WAS Patients for Blood Drawing Only|WAS patients who are either ineligible or do not want treatment but are willing to have their blood drawn once for testing
10970208|NCT00909428|BG000|Baseline|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
10970209|NCT00909428|BG001|Baseline|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
10970210|NCT00909428|BG002|Baseline|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
10970211|NCT00909428|BG003|Baseline|Total|Total of all reporting groups
10970212|NCT00909428|FG000|Participant Flow|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).
10970213|NCT00909428|FG001|Participant Flow|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
10970214|NCT00909428|FG002|Participant Flow|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
10970215|NCT00909428|OG000|Outcome|Baseline Maximal Cystometric Capacity|All patients with DOI or USI had their baseline maximal cystometric capacity recorded
10970216|NCT00909428|OG001|Outcome|One Month Maximal Cystometric Capacity|All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate.
10970217|NCT00909428|EG000|Reported Event|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
10970218|NCT00909428|EG001|Reported Event|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
10970219|NCT00909428|EG002|Reported Event|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
10970220|NCT00909480|BG000|Baseline|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
10970221|NCT00909480|BG001|Baseline|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
10970222|NCT00909480|BG002|Baseline|Total|Total of all reporting groups
11272594|NCT02735174|EG000|Reported Event|Single Arm Asthma Self-management|"Interventions include:~Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits~Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.~App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.~Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills~Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control."
10970223|NCT00909480|FG000|Participant Flow|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
10970224|NCT00909480|FG001|Participant Flow|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
11214581|NCT02293096|OG000|Outcome|Metoprolol Succinate, Genotyping, Clinical Factors, and Phenotyping|"The parent study will integrate covariates to predict metoprolol effectiveness for SBP decline of 10%. All patients will receive metoprolol. The following covariates will be used to predict metoprolol effectiveness: clinical variables (Age, sex, race/ethnicity, co-medications, and BMI) CYP2D6 genotype, CYP2D6 phenotype, and metabolomic factors.~metoprolol succinate~Genotyping: CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete.~CYP2D6 Phenotyping: Phenotype can be discordant from what is predicted by genotype. CYP2D6 henotyping using dextromethorphan will be used. Investigators will be blind to the patient blood pressure outcome for this intervention."
11214582|NCT02293096|EG000|Reported Event|Metoprolol Succinate, Genotyping, Clinical Factors, and Phenotyping|"The parent study will integrate covariates to predict metoprolol effectiveness for SBP decline of 10%. All patients will receive metoprolol. The following covariates will be used to predict metoprolol effectiveness: clinical variables (Age, sex, race/ethnicity, co-medications, and BMI) CYP2D6 genotype, CYP2D6 phenotype, and metabolomic factors.~metoprolol succinate~Genotyping: CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete.~CYP2D6 Phenotyping: Phenotype can be discordant from what is predicted by genotype. CYP2D6 henotyping using dextromethorphan will be used. Investigators will be blind to the patient blood pressure outcome for this intervention."
11214583|NCT02293395|BG000|Baseline|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214584|NCT02293395|BG001|Baseline|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214585|NCT02293395|BG002|Baseline|Total|Total of all reporting groups
11214586|NCT02293395|FG000|Participant Flow|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214587|NCT02293395|FG001|Participant Flow|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214588|NCT02293395|OG000|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214589|NCT02293395|OG001|Outcome|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214590|NCT02293395|EG000|Reported Event|Rivaroxaban 2.5 mg Twice Daily (BID)|Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214591|NCT02293395|EG001|Reported Event|Acetylsalicylic Acid 100 mg Once Daily (OD)|Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
11214592|NCT02293460|BG000|Baseline|Total Treated Set|All subjects who received at least one infusion of I10E
11214593|NCT02293460|FG000|Participant Flow|Single Arm|This study included patients never previously treated with IgG and patients already treated with IgG but in clinical relapse following IgG therapy discontinuation.
11214594|NCT02293460|OG000|Outcome|Full Analysis Set|All TTS subjects having an available assessment of the primary efficacy criteria.
11214595|NCT02293460|EG000|Reported Event|Total Treated Set|All subjects who received at least one infusion of I10E
11214596|NCT02293499|BG000|Baseline|Adult Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the adult-led control group."
11214597|NCT02293499|BG001|Baseline|Peer Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the peer--led intervention group."
11214598|NCT02293499|BG002|Baseline|Peer Leaders|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This group is the peer leaders who facilitated the Peer--led intervention group intervention."
11214599|NCT02293499|BG003|Baseline|Total|Total of all reporting groups
11214600|NCT02293499|FG000|Participant Flow|Adult Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the adult-led control group."
11214601|NCT02293499|FG001|Participant Flow|Peer Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the peer-led intervention group."
11214602|NCT02293499|FG002|Participant Flow|Peer Leaders|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This group is the peer leaders who facilitated the Peer--led intervention group intervention."
11214603|NCT02293499|OG000|Outcome|Adult Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the adult-led control group."
11214604|NCT02293499|OG001|Outcome|Peer Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the peer-led intervention group."
11214605|NCT02293499|OG002|Outcome|Peer Leaders|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This group is the peer leaders who facilitated the Peer--led intervention group intervention."
11214606|NCT02293499|OG001|Outcome|Peer Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the peer--led intervention group."
11214607|NCT02293499|EG000|Reported Event|Adult Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the adult-led control group."
11214608|NCT02293499|EG001|Reported Event|Peer Led Asthma Self-Management|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This arm is the peer-led intervention group."
11214609|NCT02293499|EG002|Reported Event|Peer Leaders|"PLASMA: A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. This group is the peer leaders who facilitated the Peer--led intervention group intervention."
11214610|NCT02293512|BG000|Baseline|Coping Effectiveness Training (CET)|"A 3-session intervention to facilitate coping strategies among individuals with tinnitus.~Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not."
11214611|NCT02293512|BG001|Baseline|Cognitive-behavioral Therapy (CBT)|"A 3-session intervention to reduce negative affectivity triggered by tinnitus.~Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal."
11214612|NCT02293512|BG002|Baseline|Acceptance and Commitment Therapy|"A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus.~Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values."
11214613|NCT02293512|BG003|Baseline|Wait-list Control Group|No intervention. This is a 'usual care' group.
11214614|NCT02293512|BG004|Baseline|Total|Total of all reporting groups
11214615|NCT02293512|FG000|Participant Flow|Coping Effectiveness Training (CET)|"A 3-session intervention to facilitate coping strategies among individuals with tinnitus.~Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not."
11214616|NCT02293512|FG001|Participant Flow|Cognitive-behavioral Therapy (CBT)|"A 3-session intervention to reduce negative affectivity triggered by tinnitus.~Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal."
11214617|NCT02293512|FG002|Participant Flow|Acceptance and Commitment Therapy|"A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus.~Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values."
11214618|NCT02293512|FG003|Participant Flow|Wait-list Control Group|No intervention. This is a 'usual care' group.
11272595|NCT02735187|BG000|Baseline|group30|"Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272596|NCT02735187|BG001|Baseline|group15|"Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272597|NCT02735187|BG002|Baseline|Total|Total of all reporting groups
11272598|NCT02735187|FG000|Participant Flow|group30|"Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272599|NCT02735187|FG001|Participant Flow|group15|"Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272600|NCT02735187|OG000|Outcome|group30 (Blue Light)|Treatment of the target area with 30 minutes of blue light at 453nm
11272601|NCT02735187|OG001|Outcome|group30 (Comparator)|Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
11272602|NCT02735187|OG000|Outcome|group15 (Blue Light)|Treatment of the target area with 30 minutes of blue light at 453nm
11272603|NCT02735187|OG001|Outcome|group15 (Comparator)|Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
11272604|NCT02735187|OG002|Outcome|group15 (Blue Light)|Treatment of the target area with 15 minutes of blue light at 453nm
11272605|NCT02735187|OG003|Outcome|group15 (Comparator)|Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
11272606|NCT02735187|OG000|Outcome|group30|"Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272607|NCT02735187|OG001|Outcome|group15|"Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272608|NCT02735187|EG000|Reported Event|group30|"Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272609|NCT02735187|EG001|Reported Event|group15|"Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.~Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.~Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)"
11272610|NCT02735200|BG000|Baseline|Topical Application of Vitamin D3|this arm received topical vitamin D3 1gram (5000IU)
11272611|NCT02735200|BG001|Baseline|Application of Aloe Vera Gel|Intervention: aloe vera gel administration 1 gram
11272612|NCT02735200|BG002|Baseline|Total|Total of all reporting groups
11272613|NCT02735200|FG000|Participant Flow|Application of Aloe Vera Gel|Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.
11272614|NCT02735200|FG001|Participant Flow|Topical Application of Vitamin D3|topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
11272615|NCT02735200|OG000|Outcome|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
11272616|NCT02735200|OG001|Outcome|Application of Aloe Vera Gel|Intervention: aloe vera gel administration
11272617|NCT02735200|EG000|Reported Event|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
11272618|NCT02735200|EG001|Reported Event|Application of Aloe Vera Gel|"Intervention: aloe vera gel administration~topical vitamin D3 in intervention group: local application"
11272619|NCT02735382|BG000|Baseline|EHR-based Referral to Quit Line|"Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline EHR referral~Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics."
11272620|NCT02735382|BG001|Baseline|Fax-based Referral to Quit Line|"Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline Fax referral~Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics."
10847373|NCT00282984|EG000|Reported Event|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
10970225|NCT00909480|OG000|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
11272621|NCT02735382|BG002|Baseline|EHR-based Clinic Staff|"Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.~Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics."
11272622|NCT02735382|BG003|Baseline|Fax-based Referral to Quit Line Clinic Staff|"Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.~Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics."
11272623|NCT02735382|BG004|Baseline|Total|Total of all reporting groups
11272624|NCT02735382|FG000|Participant Flow|EHR-based Referral to Quit Line|"Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline EHR referral~Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics."
11272625|NCT02735382|FG001|Participant Flow|Fax-based Referral to Quit Line|"Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline Fax referral~Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics."
11272626|NCT02735382|FG002|Participant Flow|EHR-based Referral to Quit Line Clinic Staff|Staff in these clinics that use EHR-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272627|NCT02735382|FG003|Participant Flow|Fax-based Referral to Quit Line Clinic Staff|Staff in these clinics that use Fax-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272628|NCT02735382|OG000|Outcome|EHR-based Referral to Quit Line|"Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline EHR referral~Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics."
11272629|NCT02735382|OG001|Outcome|Fax-based Referral to Quit Line|"Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline Fax referral~Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics."
11272630|NCT02735382|OG000|Outcome|EHR-based Referral to Quit Line Clinic Staff|Staff in these clinics that use EHR-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272631|NCT02735382|OG001|Outcome|Fax-based Referral to Quit Line Clinic Staff|Staff in these clinics that use Fax-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272632|NCT02735382|EG000|Reported Event|EHR-based Referral to Quit Line|"Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline EHR referral~Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics."
11272633|NCT02735382|EG001|Reported Event|Fax-based Referral to Quit Line|"Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.~Intervention: Behavioral: Tobacco quitline Fax referral~Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics."
11272634|NCT02735382|EG002|Reported Event|EHR-based Referral to Quit Line Clinic Staff|Staff in these clinics that use EHR-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272635|NCT02735382|EG003|Reported Event|Fax-based Referral to Quit Line Clinic Staff|Staff in these clinics that use Fax-based referral to the quit line will complete surveys to address Aim 4 of the study.
11272636|NCT02735421|BG000|Baseline|All Participants|Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face and adapalene 0.3% - BPO 2.5% vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks.
11272637|NCT02735421|FG000|Participant Flow|All Participants|Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face and adapalene 0.3% - BPO 2.5% vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks.
11272638|NCT02735421|OG000|Outcome|Adapalene / BPO Gel|Participants applied once-daily adapalene 0.3% - BPO 2.5% gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
11272639|NCT02735421|OG001|Outcome|Vehicle Gel|Participants applied once-daily adapalene 0.3% - BPO 2.5% vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
11272640|NCT02735421|EG000|Reported Event|Adapalene / BPO Side|On the side treated with Adapalene 0.3% / BPO 2.5% gel, once daily in the evening on half of the face (determined by randomization).
11272641|NCT02735421|EG001|Reported Event|Vehicle Side|On the side treated with Vehicle gel, once daily in the evening on half of the face (determined by randomization).
11272642|NCT02735421|EG002|Reported Event|Unspecific Treated Side|Unspecific treated site.
11272643|NCT02735551|BG000|Baseline|Non-LARC Group: Short Acting Method|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services~Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice"
11272644|NCT02735551|BG001|Baseline|Control Group: Referral for LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to referral for LARC placement to local clinic.~Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)"
11272645|NCT02735551|BG002|Baseline|LARC Group: Same Day LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to same day LARC placement (intervention).~Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon"
11272646|NCT02735551|BG003|Baseline|Total|Total of all reporting groups
11272647|NCT02735551|FG000|Participant Flow|Non-LARC Group: Short Acting Method|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services~Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice"
11272648|NCT02735551|FG001|Participant Flow|Control Group: Referral for LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to referral for LARC placement to local clinic.~Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)"
11272649|NCT02735551|FG002|Participant Flow|LARC Group: Same Day LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to same day LARC placement (intervention).~Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon"
11272650|NCT02735551|OG000|Outcome|Non-LARC Group: Short Acting Method|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services~Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice"
11272651|NCT02735551|OG001|Outcome|Control Group: Referral for LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to referral for LARC placement to local clinic.~Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)"
11272652|NCT02735551|OG002|Outcome|LARC Group: Same Day LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to same day LARC placement (intervention).~Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon"
11272653|NCT02735551|EG000|Reported Event|Non-LARC Group: Short Acting Method|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services~Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice"
11272654|NCT02735551|EG001|Reported Event|Control Group: Referral for LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to referral for LARC placement to local clinic.~Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)"
11272655|NCT02735551|EG002|Reported Event|LARC Group: Same Day LARC Placement|"All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to same day LARC placement (intervention).~Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon"
11272656|NCT02735577|BG000|Baseline|Disulfiram|"Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days.~Disulfiram: Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment."
11272657|NCT02735577|FG000|Participant Flow|Disulfiram|"Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days.~Disulfiram: Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment."
11272658|NCT02735577|OG000|Outcome|Disulfiram|"Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days.~Disulfiram: Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment."
11272659|NCT02735577|EG000|Reported Event|Disulfiram|"Patients in this arm will receive disulfiram 250 mg daily for a total of 42 days.~Disulfiram: Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment."
11272660|NCT02735642|BG000|Baseline|Home-based Recruitment Strategy|We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
11272661|NCT02735642|BG001|Baseline|Mobile Event Based Recruitment Strategy|We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
11272662|NCT02735642|BG002|Baseline|Total|Total of all reporting groups
11272663|NCT02735642|FG000|Participant Flow|Aim 1: Home-based Recruitment Strategy|In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.
11272664|NCT02735642|FG001|Participant Flow|Aim 1: Mobile Event Based Recruitment Strategy|In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.
11272665|NCT02735642|OG000|Outcome|Home-based Recruitment Strategy|In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.
11272666|NCT02735642|OG001|Outcome|Mobile Event Based Recruitment Strategy|In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.
11272667|NCT02735642|OG000|Outcome|SMART Randomization 1 - Referral|"Newly diagnosed adolescent girls and young women living with HIV were enrolled into a SMART trial to pilot adaptive interventions to support them with initial linkage to treatment and care services.~In the first randomization, participants in this arm were randomized to referral."
11272668|NCT02735642|OG001|Outcome|SMART Randomization 1 - Referral and SMS|"Newly diagnosed adolescent girls and young women living with HIV were enrolled into a SMART trial to pilot adaptive interventions to support them with initial linkage to treatment and care services.~In the first randomization, participants in this arm were randomized to receive referral and SMS message."
11272669|NCT02735642|OG002|Outcome|SMART Randomization 2 - SMS|"Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care.~In this second randomization, participants in this arm were randomized to receive an SMS message."
11272670|NCT02735642|OG003|Outcome|SMART Randomization 2 - Incentive|"Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care.~In this second randomization, participants in this arm were randomized to receive an economic incentive."
11272671|NCT02735642|EG000|Reported Event|Home-based Recruitment Strategy|We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
11272672|NCT02735642|EG001|Reported Event|Mobile Event Based Recruitment Strategy|We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
11272673|NCT02735915|BG000|Baseline|GSK1437173A Vaccine Group|Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
11272674|NCT02735915|FG000|Participant Flow|GSK1437173A Vaccine Group|Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
11272675|NCT02735915|OG000|Outcome|GSK1437173A Vaccine Group|Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
11272676|NCT02735915|OG000|Outcome|GSK1437173A Vaccine 60-69 YOA Sub-group|Subjects of 60-69 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
11272677|NCT02735915|OG001|Outcome|GSK1437173A Vaccine ≥ 70 YOA Sub-group|Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
11272678|NCT02735915|EG000|Reported Event|GSK1437173A Vaccine Group|Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
11272679|NCT02735980|BG000|Baseline|Prexasertib (Platinum Sensitive Disease)|Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
11272680|NCT02735980|BG001|Baseline|Prexasertib (Platinum Resistant Disease)|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272681|NCT02735980|BG002|Baseline|Prexasertib Exploratory Addendum (Platinum Sensitive Disease)|IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
11272682|NCT02735980|BG003|Baseline|Total|Total of all reporting groups
11272683|NCT02735980|FG000|Participant Flow|105 mg/m^2 Prexasertib (Platinum Sensitive Disease)|Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
11272684|NCT02735980|FG001|Participant Flow|105 mg/m^2 Prexasertib (Platinum Resistant Disease)|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272685|NCT02735980|FG002|Participant Flow|40 mg/m2 Prexasertib Exploratory Addendum|40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
11272686|NCT02735980|OG000|Outcome|Prexasertib (Platinum Sensitive Disease)|Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272687|NCT02735980|OG001|Outcome|Prexasertib (Platinum Resistant Disease)|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272688|NCT02735980|OG002|Outcome|Prexasertib Exploratory Addendum (Platinum Sensitive Disease)|IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
11272689|NCT02735980|OG000|Outcome|105 mg/m^2 Prexasertib|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272690|NCT02735980|OG000|Outcome|40 mg/m2 Prexasertib Exploratory Addendum|40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
11272691|NCT02735980|OG000|Outcome|Cohort 1 Prexasertib (Platinum Sensitive Disease)|Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272692|NCT02735980|OG001|Outcome|Cohort 2 Prexasertib (Platinum Resistant Disease)|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272693|NCT02735980|OG002|Outcome|Cohort 3 Prexasertib Exploratory(Platinum Sensitive Disease)|IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
11272694|NCT02735980|EG000|Reported Event|105 mg/m^2 Prexasertib (Platinum Sensitive Disease)|Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
11272695|NCT02735980|EG001|Reported Event|105 mg/m^2 Prexasertib (Platinum Resistant Disease)|IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
11272696|NCT02735980|EG002|Reported Event|40 mg/m2 Prexasertib Exploratory Addendum|IV 40 mg/m2 prexasertib (LY2606368) IV administered on Days 1, 2 and 3 of a 14-day cycle
11272697|NCT02736175|BG000|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11272698|NCT02736175|BG001|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
11272699|NCT02736175|BG002|Baseline|Total|Total of all reporting groups
11272700|NCT02736175|FG000|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11272701|NCT02736175|FG001|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
11272702|NCT02736175|OG000|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11272703|NCT02736175|OG001|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
11272704|NCT02736175|EG000|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11272705|NCT02736175|EG001|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
11272706|NCT02736188|BG000|Baseline|Ace-ER 6 g/Day|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day
11272707|NCT02736188|FG000|Participant Flow|Ace-ER 6 g/Day|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day
11272708|NCT02736188|OG000|Outcome|Ace-ER 6 g/Day|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day
11272709|NCT02736188|OG000|Outcome|Ace-ER 6 g/Day (Parent Study Treatment: Ace-ER 6 g/Day)|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day in participants who took Ace-ER in study UX001-CL301 (NCT02377921)
11272710|NCT02736188|OG001|Outcome|Ace-ER 6 g/Day (Parent Study Treatment: Placebo)|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day in participants who took placebo in study UX001-CL301 (NCT02377921)
11272711|NCT02736188|EG000|Reported Event|Ace-ER 6 g/Day|4 tablets (500 mg Ace-ER each for 2 g per dose) orally 3 times per day
11286825|NCT02894502|FG001|Participant Flow|Motivational Interviewing to Patients and Caregivers|"In this arm the interventions will be delivered both to patients and caregivers~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11286826|NCT02894502|FG002|Participant Flow|Control Group|This Group will receive the usual care
11286827|NCT02894502|OG000|Outcome|Motivational Interviewing Only for Patients|"In this arm the interventions will be delivered only to patients~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11286828|NCT02894502|OG001|Outcome|Motivational Interviewing to Patients and Caregivers|"In this arm the interventions will be delivered both to patients and caregivers~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11272712|NCT02736409|BG000|Baseline|Full Responder BOS-PBO Group|Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.
11272713|NCT02736409|BG001|Baseline|Full Responder BOS-BOS Group|Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272714|NCT02736409|BG002|Baseline|Non-Responder BOS-BOS Group|Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272715|NCT02736409|BG003|Baseline|PBO-BOS Group|PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272716|NCT02736409|BG004|Baseline|Total|Total of all reporting groups
11272717|NCT02736409|FG000|Participant Flow|Full Responder BOS-PBO Group|Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.
11272718|NCT02736409|FG001|Participant Flow|Full Responder BOS-BOS Group|Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272719|NCT02736409|FG002|Participant Flow|Non-Responder BOS-BOS Group|Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272720|NCT02736409|FG003|Participant Flow|PBO-BOS Group|PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272721|NCT02736409|OG000|Outcome|Full Responder BOS-PBO Group|Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.
11272722|NCT02736409|OG001|Outcome|Full Responder BOS-BOS Group|Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272723|NCT02736409|OG000|Outcome|Non-Responder BOS-BOS Group|Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272724|NCT02736409|OG002|Outcome|Non-Responder BOS-BOS Group|Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272725|NCT02736409|OG003|Outcome|PBO-BOS Group|PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272726|NCT02736409|EG000|Reported Event|Full Responder BOS-PBO Group|Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.
11272727|NCT02736409|EG001|Reported Event|Full Responder BOS-BOS Group|Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272728|NCT02736409|EG002|Reported Event|Non-Responder BOS-BOS Group|Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272729|NCT02736409|EG003|Reported Event|PBO-BOS Group|PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
11272730|NCT02736474|BG000|Baseline|Naltrexone and Bupropion|"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.~Naltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.~Bupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."
11286829|NCT02894502|OG002|Outcome|Control Group|This Group will receive the usual care
11286830|NCT02894502|OG000|Outcome|Motivational Interviewing Only for Patients|In this Arm, motivational interviewing will be provided only to patients
11272731|NCT02736474|BG001|Baseline|Placebo Naltrexone and Bupropion|"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.~Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.~Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."
11272732|NCT02736474|BG002|Baseline|Total|Total of all reporting groups
11272733|NCT02736474|FG000|Participant Flow|Naltrexone and Bupropion|"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.~Naltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.~Bupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."
11272734|NCT02736474|FG001|Participant Flow|Placebo Naltrexone and Bupropion|"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.~Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.~Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."
11272735|NCT02736474|OG000|Outcome|Naltrexone and Bupropion|"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.~Naltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.~Bupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."
11272736|NCT02736474|OG001|Outcome|Placebo Naltrexone and Bupropion|"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.~Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.~Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."
11272737|NCT02736474|EG000|Reported Event|Naltrexone and Bupropion|"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.~Naltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.~Bupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."
10847374|NCT00282984|EG001|Reported Event|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
11272738|NCT02736474|EG001|Reported Event|Placebo Naltrexone and Bupropion|"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.~Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.~Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."
11272739|NCT02736578|BG000|Baseline|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272740|NCT02736578|BG001|Baseline|Cetuximab IRDye800, 100 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272741|NCT02736578|BG002|Baseline|Total|Total of all reporting groups
11272742|NCT02736578|FG000|Participant Flow|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272743|NCT02736578|FG001|Participant Flow|Cetuximab IRDye800, 100 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272744|NCT02736578|OG000|Outcome|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272745|NCT02736578|OG000|Outcome|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
10970226|NCT00909480|OG001|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
11272746|NCT02736578|OG000|Outcome|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272747|NCT02736578|OG001|Outcome|Cetuximab IRDye800, 100 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272748|NCT02736578|OG002|Outcome|Cetuximab IRDye800, Both Doses|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272749|NCT02736578|OG001|Outcome|Cetuximab IRDye800, 100 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272750|NCT02736578|EG000|Reported Event|Cetuximab IRDye800, 50 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272751|NCT02736578|EG001|Reported Event|Cetuximab IRDye800, 100 mg|"On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.~Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg~Cetuximab: Administered as a 100 mg IV loading dose"
11272752|NCT02736721|BG000|Baseline|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
11272753|NCT02736721|FG000|Participant Flow|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
11272754|NCT02736721|OG000|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
11272755|NCT02736721|EG000|Reported Event|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
11272756|NCT02736825|BG000|Baseline|Group A|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
11272757|NCT02736825|BG001|Baseline|Group B|Participants received single comparable treatment with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducer DS 4-4.5 at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0 S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
11272758|NCT02736825|BG002|Baseline|Total|Total of all reporting groups
11272759|NCT02736825|FG000|Participant Flow|Group A|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 percent [%]) at the 4.5 millimeter (mm) and 3.0 mm depths at EL 2, using standard transducers DeepSEE (DS) 4-4.5 at 0.9 joules (J) with pitch of 1.5 mm and 17 thermal coagulation points (TCPs) per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
10970227|NCT00909480|EG000|Reported Event|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
11272760|NCT02736825|FG001|Participant Flow|Group B|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
11272761|NCT02736825|OG000|Outcome|Group A|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
10970228|NCT00909480|EG001|Reported Event|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
11272762|NCT02736825|OG001|Outcome|Group B|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
11286831|NCT02894502|OG001|Outcome|Motivational Interviewing for Patients and Caregivers|In this Arm, motivational interviewing will be provided to patients and caregivers
10970229|NCT00909532|BG000|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
10970230|NCT00909532|BG001|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
10970231|NCT00909532|BG002|Baseline|Total|Total of all reporting groups
10970232|NCT00909532|FG000|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
11272763|NCT02736825|OG001|Outcome|Group B|Participants received single comparable treatment with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducer DS 4-4.5 at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0 S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
11272764|NCT02736825|EG000|Reported Event|Group A|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5 %) at the 4.5 mm and 3.0 mm depths at EL 2, using standard transducers DS 4-4.5 at 0.9 J with pitch of 1.5 mm and 17 TCPs per line and DS 7-3.0 at 0.30 J with pitch of 1.1 mm and 23 TCPs per line.
11272765|NCT02736825|EG001|Reported Event|Group B|Participants received single Ultherapy treatment to the lower face and neck with a total minimum pulse count of 336 pulses (+5%) at the 4.5 mm and 3.0 mm depths at EL 2 using prototype 2 simulines transducers DS 4-4.5S at 1.23 J with pitch of 1.5 mm and 17 TCPs per line and DS 4-3.0S at 0.88 J with pitch of 1.3 mm and 20 TCPs per line.
11272766|NCT02736890|BG000|Baseline|Botulinum Toxin A Then Placebo|Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
11272767|NCT02736890|BG001|Baseline|Placebo Then Botulinum Toxin A|Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
11272768|NCT02736890|BG002|Baseline|Total|Total of all reporting groups
11272769|NCT02736890|FG000|Participant Flow|Botulinum Toxin A Then Placebo|Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
11272770|NCT02736890|FG001|Participant Flow|Placebo Then Botulinum Toxin A|Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
11272771|NCT02736890|OG000|Outcome|Botulinum Toxin A Then Placebo|Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
11272772|NCT02736890|OG001|Outcome|Placebo Then Botulinum Toxin A|Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
11272773|NCT02736890|EG000|Reported Event|Botulinum Toxin A|Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks
11272774|NCT02736890|EG001|Reported Event|Placebo|Placebo 0.2mL of 0.9% normal saline for 12 weeks
11272775|NCT02736955|BG000|Baseline|Valbenazine 40 mg|Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
11272776|NCT02736955|BG001|Baseline|Valbenazine 80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
11272777|NCT02736955|BG002|Baseline|Valbenazine 40/80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
11272778|NCT02736955|BG003|Baseline|Total|Total of all reporting groups
11272779|NCT02736955|FG000|Participant Flow|Valbenazine 40 mg|Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks
11272780|NCT02736955|FG001|Participant Flow|Valbenazine 80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
11272781|NCT02736955|FG002|Participant Flow|Valbenazine 40/80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
11272782|NCT02736955|OG000|Outcome|Valbenazine 40 mg|Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
11272783|NCT02736955|OG001|Outcome|Valbenazine 80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
11272784|NCT02736955|OG002|Outcome|Valbenazine 40/80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
11272785|NCT02736955|OG000|Outcome|Valbenazine 40 mg|Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks
11272786|NCT02736955|EG000|Reported Event|Valbenazine 40 mg|Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
11272787|NCT02736955|EG001|Reported Event|Valbenazine 80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks
11272788|NCT02736955|EG002|Reported Event|Valbenazine 40/80 mg|Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
11272789|NCT02737072|BG000|Baseline|20 mg LY2510924 + 1500 mg Durvalumab|20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).
11272790|NCT02737072|BG001|Baseline|30 mg LY2510924 + 1500 mg Durvalumab|30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272791|NCT02737072|BG002|Baseline|40 mg LY2510924 + 1500 mg Durvalumab|40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272792|NCT02737072|BG003|Baseline|Total|Total of all reporting groups
11272793|NCT02737072|FG000|Participant Flow|20 mg LY2510924 + 1500 mg Durvalumab|20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).
11272794|NCT02737072|FG001|Participant Flow|30 mg LY2510924 + 1500 mg Durvalumab|30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272795|NCT02737072|FG002|Participant Flow|40 mg LY2510924 + 1500 mg Durvalumab|40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272796|NCT02737072|OG000|Outcome|20 mg LY2510924 + 1500 mg Durvalumab|20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).
11272797|NCT02737072|OG001|Outcome|30 mg LY2510924 + 1500 mg Durvalumab|30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272798|NCT02737072|OG002|Outcome|40 mg LY2510924 + 1500 mg Durvalumab|40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272799|NCT02737072|OG000|Outcome|All Phase 1a Participants|"20 mg LY2510924 + 1500 mg Durvalumab:~20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).~30 mg LY2510924 + 1500 mg Durvalumab:~30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).~40 mg LY2510924 + 1500 mg Durvalumab:~40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days)."
11272800|NCT02737072|OG000|Outcome|20 mg LY2510924 + 1500 mg Durvalumab|20 milligrams (mg) LY2510924 given subcutaneously (SQ) in combination with 1500 mg durvalumab given intravenously (IV).
11272801|NCT02737072|OG001|Outcome|30 mg LY2510924 + 1500 mg Durvalumab|30 mg LY2510924 given SQ in combination with 1500 mg durvalumab given IV.
11272802|NCT02737072|OG002|Outcome|40 mg LY2510924 + 1500 mg Durvalumab|40 mg LY2510924 given SQ in combination with 1500 mg durvalumab given IV.
11272803|NCT02737072|EG000|Reported Event|20 mg LY2510924 + 1500 mg Durvalumab|20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).
11272804|NCT02737072|EG001|Reported Event|30 mg LY2510924 + 1500 mg Durvalumab|30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
11272805|NCT02737072|EG002|Reported Event|40 mg LY2510924 + 1500 mg Durvalumab|40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
10970233|NCT00909532|FG001|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
11272806|NCT02737163|BG000|Baseline|Observational Single Encounter Assessment|"Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at single encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findings."
11272807|NCT02737163|FG000|Participant Flow|Observational Single Ecounter Assessment|"Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at single encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findings."
10970234|NCT00909532|OG000|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
10970235|NCT00909532|OG001|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
11272808|NCT02737163|OG000|Outcome|Observational Single Ecounter Assessment|"Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at single encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs."
11272809|NCT02737163|EG000|Reported Event|Observational Single Ecounter Assessment|"Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at single encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs."
11272810|NCT02737332|BG000|Baseline|Zytiga® (Abiraterone Acetate)|Zytiga® 1,000 mg (4 x 250 mg qd) tablets
11272811|NCT02737332|BG001|Baseline|SoluMatrix™ (Abiraterone Acetate)|SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
11272812|NCT02737332|BG002|Baseline|Total|Total of all reporting groups
11272813|NCT02737332|FG000|Participant Flow|Zytiga® (Abiraterone Acetate)|Zytiga® 1,000 mg (4 x 250 mg qd) tablets
11272814|NCT02737332|FG001|Participant Flow|SoluMatrix™ (Abiraterone Acetate)|SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
11272815|NCT02737332|OG000|Outcome|Zytiga® (Abiraterone Acetate)|Zytiga® 1,000 mg (4 x 250 mg qd) tablets
11272816|NCT02737332|OG001|Outcome|SoluMatrix™ (Abiraterone Acetate)|SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
11272817|NCT02737332|OG000|Outcome|Zytiga® (Abiraterone Acetate)|Zytiga® 1,000 mg (4 x 250 mg qd) tablets.
11272818|NCT02737332|OG001|Outcome|SoluMatrix™ (Abiraterone Acetate)|"500 mg (4 x 125 mg qd)~SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)"
11272819|NCT02737332|EG000|Reported Event|Zytiga® (Abiraterone Acetate)|"1,000 MG (4 x 250 mg qd)~Zytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg"
11272820|NCT02737332|EG001|Reported Event|SoluMatrix™ (Abiraterone Acetate)|"500 mg (4 x 125 mg qd)~SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)"
11272821|NCT02737358|BG000|Baseline|Placebo|"Matched placebo will be given to half of the study participants.~Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support."
11272822|NCT02737358|BG001|Baseline|N-Acetylcysteine (NAC)|"NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)~N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks."
11272823|NCT02737358|BG002|Baseline|Total|Total of all reporting groups
11272824|NCT02737358|FG000|Participant Flow|Placebo|"Matched placebo will be given to half of the study participants.~Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support."
11272825|NCT02737358|FG001|Participant Flow|N-Acetylcysteine (NAC)|"NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)~N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks."
11272826|NCT02737358|OG000|Outcome|Placebo|"Matched placebo will be given to half of the study participants.~Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support."
11272827|NCT02737358|OG001|Outcome|N-Acetylcysteine (NAC)|"NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)~N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks."
11272828|NCT02737358|EG000|Reported Event|Placebo|"Matched placebo will be given to half of the study participants.~Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support."
11272829|NCT02737358|EG001|Reported Event|N-Acetylcysteine (NAC)|"NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)~N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks."
11272830|NCT02737397|BG000|Baseline|All Study Participants|Participants were randomized to receive 4 sequences of drug therapy including placebo.
11272831|NCT02737397|FG000|Participant Flow|All Study Participants|"JMI-001 (SJP-304 and SJP-223), single dose~SJP-304 + placebo~SJP-223 + placebo~placebo + placebo"
11272832|NCT02737397|OG000|Outcome|Pain Medicine and Antihistamine|"JMI-001 (SJP-304 and SJP-223)~JMI-001 (SJP-304 and SJP-223)"
11272833|NCT02737397|OG001|Outcome|Pain Medicine|"SJP-304 and placebo~SJP-304~placebo"
11272834|NCT02737397|OG002|Outcome|Antihistamine|"SJP-223 and placebo~SJP-223~placebo"
11272835|NCT02737397|OG003|Outcome|Placebo|Placebo + placebo, single dose
11272836|NCT02737397|EG000|Reported Event|Pain Medicine and Antihistamine|"JMI-001 (SJP-304 and SJP-223)~JMI-001 (SJP-304 and SJP-223)"
11272837|NCT02737397|EG001|Reported Event|Pain Medicine|"SJP-304 and placebo~SJP-304~placebo"
11272838|NCT02737397|EG002|Reported Event|Antihistamine|"SJP-223 and placebo~SJP-223~placebo"
11272839|NCT02737397|EG003|Reported Event|Placebo|"placebo and placebo~placebo"
11272840|NCT02737501|BG000|Baseline|Randomized Phase: Brigatinib 90 mg QD/180 QD|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
10970236|NCT00909532|OG001|Outcome|150 mg Ivacaftor q12h|Oral tablets of 150 mg of ivacaftor q12h for up to 48 weeks.
11272841|NCT02737501|BG001|Baseline|Randomized Phase: Crizotinib 250 mg BID|Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
11272842|NCT02737501|BG002|Baseline|Total|Total of all reporting groups
11272843|NCT02737501|FG000|Participant Flow|Randomized Phase: Brigatinib 90 mg QD/180 QD|Brigatinib 90 mg, tablets, orally, once daily (QD) for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until disease progression (PD), intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
10970237|NCT00909532|EG000|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
11272844|NCT02737501|FG001|Participant Flow|Randomized Phase: Crizotinib 250 mg BID|Crizotinib 250 mg, tablets, twice daily (BID) in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
11272845|NCT02737501|FG002|Participant Flow|Crossover Phase: Brigatinib 90 mg QD/180 mg QD|Participants who experienced PD as assessed by the blinded Independent Review Committee (BIRC) or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
11272846|NCT02737501|OG000|Outcome|Randomized Phase: Brigatinib 90 mg QD/180 QD|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
11272847|NCT02737501|OG001|Outcome|Randomized Phase: Crizotinib 250 mg BID|Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
11272848|NCT02737501|OG002|Outcome|Crossover Phase: Brigatinib 90 mg QD/180 mg QD|Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
11272849|NCT02737501|EG000|Reported Event|Randomized Phase: Brigatinib 90 mg QD/180 QD|Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
11272850|NCT02737501|EG001|Reported Event|Randomized Phase: Crizotinib 250 mg BID|Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
11272851|NCT02737501|EG002|Reported Event|Crossover Phase: Brigatinib 90 mg QD/180 mg QD|Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
11272852|NCT02737592|BG000|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
11272853|NCT02737592|FG000|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
11272854|NCT02737592|OG000|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
11272855|NCT02737592|EG000|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
11272856|NCT02737618|BG000|Baseline|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272857|NCT02737618|FG000|Participant Flow|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272858|NCT02737618|OG000|Outcome|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272859|NCT02737618|EG000|Reported Event|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon Personal Lubricant applied by occlusive patch~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272860|NCT02737631|BG000|Baseline|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
11272861|NCT02737631|FG000|Participant Flow|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
11272862|NCT02737631|OG000|Outcome|Healthy Subject|"Healthy subjects exposed to Chameleon personal lubricant via occlusive patch~Chameleon Personal Lubricant"
11272863|NCT02737631|EG000|Reported Event|Healthy Subject|"Healthy subjects exposed to Trojan Chameleon personal lubricant via occlusive patch~Trojan Chameleon Personal Lubricant"
11272864|NCT02737722|BG000|Baseline|0.1% Bisphosphocin Nu-3|Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272865|NCT02737722|BG001|Baseline|1% Bisphosphocin Nu-3|Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272866|NCT02737722|BG002|Baseline|2% Bisphosphocin Nu-3|Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272867|NCT02737722|BG003|Baseline|Placebo|Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
11272868|NCT02737722|BG004|Baseline|Total|Total of all reporting groups
11272869|NCT02737722|FG000|Participant Flow|0.1% Bisphosphocin Nu-3|Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272870|NCT02737722|FG001|Participant Flow|1% Bisphosphocin Nu-3|Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272871|NCT02737722|FG002|Participant Flow|2% Bisphosphocin Nu-3|Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272872|NCT02737722|FG003|Participant Flow|Placebo|Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
11272873|NCT02737722|OG000|Outcome|0.1% Bisphosphocin Nu-3|Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272874|NCT02737722|OG001|Outcome|1% Bisphosphocin Nu-3|Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272875|NCT02737722|OG002|Outcome|2% Bisphosphocin Nu-3|Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272876|NCT02737722|OG003|Outcome|Placebo|Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
11272877|NCT02737722|EG000|Reported Event|0.1% Bisphosphocin Nu-3|Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272878|NCT02737722|EG001|Reported Event|1% Bisphosphocin Nu-3|Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272879|NCT02737722|EG002|Reported Event|2% Bisphosphocin Nu-3|Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
11272880|NCT02737722|EG003|Reported Event|Placebo|Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
11272881|NCT02737826|BG000|Baseline|All Study Participants|"In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. Buprenorphine tolerability will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol."
11272882|NCT02737826|FG000|Participant Flow|Phase I - Buprenorphine Initiation|"In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol using up to 16mg of buprenoprhine over an up to 8 hour induction window. Buprenorphine tolerability will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol."
11272883|NCT02737826|FG001|Participant Flow|Phase II - Gabapentin + Buprenorphine Taper|"Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period where buprenorphine will be titrated up as tolerated/needed to a maximum of 24 mg/day and gabapentin will be titrated up to 1600mg/day in 3 daily doses as tolerated. After the 2 week stabilization period, buprenorphine tapering will begin according to a tapering schedule that will last up to 8 weeks based on stabilizing buprenorphine dose.~After the buprenorphine taper is complete, a 1 week taper of gabapentin will be provided."
11272884|NCT02737826|FG002|Participant Flow|Phase II - Placebo + Buprenorphine Taper|"Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period where buprenorphine will be titrated up as tolerated/needed to a maximum of 24 mg/day and placebo will be titrated up to 1600mg/day in 3 daily doses as tolerated. After the 2 week stabilization period, buprenorphine tapering will begin according to a tapering schedule that will last up to 8 weeks based on stabilizing buprenorphine dose.~After the buprenorphine taper is complete, a 1 week taper of placebo will be provided."
11272885|NCT02737826|OG000|Outcome|Phase I - Buprenorphine Initiation|"In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. Buprenorphine tolerability will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol."
11272886|NCT02737826|OG000|Outcome|Phase II - Gabapentin + Buprenorphine Taper|"Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.~Gabapentin - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Placebo - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering."
11272887|NCT02737826|OG001|Outcome|Phase II - Placebo + Buprenorphine Taper|"Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.~Gabapentin - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Placebo - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering."
11272888|NCT02737826|EG000|Reported Event|Phase I - Buprenorphine Initiation|In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window.
11272889|NCT02737826|EG001|Reported Event|Phase II - Gabapentin + Buprenorphine|Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
11272890|NCT02737826|EG002|Reported Event|Phase II - Gabapentin + Placebo|Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
11272891|NCT02737826|EG003|Reported Event|Phase II - Buprenorphine Taper|After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms.
11272892|NCT02737852|BG000|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272893|NCT02737852|FG000|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
10970238|NCT00909532|EG001|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
10970239|NCT00909545|BG000|Baseline|Placebo|4 Placebo to Match (PTM) tablets once daily
10970240|NCT00909545|BG001|Baseline|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
10970241|NCT00909545|BG002|Baseline|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
10970242|NCT00909545|BG003|Baseline|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
10970243|NCT00909545|BG004|Baseline|Total|Total of all reporting groups
11272894|NCT02737852|OG000|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272895|NCT02737852|EG000|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks~Trojan Chameleon Personal Lubricant: silicone base with sensate"
11272896|NCT02737891|BG000|Baseline|Tesofensine/Metoprolol|"Oral tablets Tesofensine/Metoprolol~Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg"
11272897|NCT02737891|BG001|Baseline|Placebo|"Placebo tablets matching oral Tesofensine/Metoprolol~Placebo"
11272898|NCT02737891|BG002|Baseline|Total|Total of all reporting groups
11272899|NCT02737891|FG000|Participant Flow|Tesofensine/Metoprolol|"Oral tablets Tesofensine/Metoprolol~Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg"
11272900|NCT02737891|FG001|Participant Flow|Placebo|"Placebo tablets matching oral Tesofensine/Metoprolol~Placebo"
11272901|NCT02737891|OG000|Outcome|Tesofensine/Metoprolol|"Oral tablets Tesofensine/Metoprolol~Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg"
11272902|NCT02737891|OG001|Outcome|Placebo|"Placebo tablets matching oral Tesofensine/Metoprolol~Placebo"
11272903|NCT02737891|EG000|Reported Event|Tesofensine/Metoprolol|"Oral tablets Tesofensine/Metoprolol~Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg"
11272904|NCT02737891|EG001|Reported Event|Placebo|"Placebo tablets matching oral Tesofensine/Metoprolol~Placebo"
11272905|NCT02737917|BG000|Baseline|Apneic Oxygenation|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.~Oxygen: 15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.~Standard of care: Rapid sequence intubation"
11272906|NCT02737917|BG001|Baseline|Usual Care|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)~Standard of care: Rapid sequence intubation"
11272907|NCT02737917|BG002|Baseline|Total|Total of all reporting groups
11272908|NCT02737917|FG000|Participant Flow|Apneic Oxygenation|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.~Oxygen: 15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.~Standard of care: Rapid sequence intubation"
11272909|NCT02737917|FG001|Participant Flow|Usual Care|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)~Standard of care: Rapid sequence intubation"
11272910|NCT02737917|OG000|Outcome|Apneic Oxygenation|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.~Oxygen: 15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.~Standard of care: Rapid sequence intubation"
11272911|NCT02737917|OG001|Outcome|Usual Care|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)~Standard of care: Rapid sequence intubation"
11272912|NCT02737917|EG000|Reported Event|Apneic Oxygenation|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.~Oxygen: 15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.~Standard of care: Rapid sequence intubation"
11272913|NCT02737917|EG001|Reported Event|Usual Care|"This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)~Standard of care: Rapid sequence intubation"
11272914|NCT02737930|BG000|Baseline|Fluoxetine|"20 mg fluoxetine capsule by mouth once daily for 90 days~Fluoxetine"
11272915|NCT02737930|BG001|Baseline|Placebo|"Matching placebo~Placebo"
11272916|NCT02737930|BG002|Baseline|Total|Total of all reporting groups
11272917|NCT02737930|FG000|Participant Flow|Fluoxetine|"20 mg fluoxetine capsule by mouth once daily for 90 days~Fluoxetine"
11272918|NCT02737930|FG001|Participant Flow|Placebo|"Matching placebo~Placebo"
11272919|NCT02737930|OG000|Outcome|Fluoxetine|"20 mg fluoxetine capsule by mouth once daily for 90 days~Fluoxetine"
11272920|NCT02737930|OG001|Outcome|Placebo|"Matching placebo~Placebo"
11272921|NCT02737930|EG000|Reported Event|Fluoxetine|"20 mg fluoxetine capsule by mouth once daily for 90 days~Fluoxetine"
11272922|NCT02737930|EG001|Reported Event|Placebo|"Matching placebo~Placebo"
11272923|NCT02738008|BG000|Baseline|Heparc-2002: ARC-520 1.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272924|NCT02738008|BG001|Baseline|Heparc-2002: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272925|NCT02738008|BG002|Baseline|Heparc-2003: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272926|NCT02738008|BG003|Baseline|Total|Total of all reporting groups
11272927|NCT02738008|FG000|Participant Flow|Heparc-2002: ARC-520 1.0 mg/kg|ARC-520 2.0 mg/kg administered by intravenous (IV) infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272928|NCT02738008|FG001|Participant Flow|Heparc-2002: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272929|NCT02738008|FG002|Participant Flow|Heparc-2003: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272930|NCT02738008|OG000|Outcome|Heparc-2002: ARC-520 1.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272931|NCT02738008|OG001|Outcome|Heparc-2002: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272932|NCT02738008|OG002|Outcome|Heparc-2003: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272933|NCT02738008|EG000|Reported Event|Heparc-2002: ARC-520 1.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272934|NCT02738008|EG001|Reported Event|Heparc-2002: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272935|NCT02738008|EG002|Reported Event|Heparc-2003: ARC-520 2.0 mg/kg|ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
11272936|NCT02738086|BG000|Baseline|Early PABC Intervention|"GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272937|NCT02738086|BG001|Baseline|Wait-List Control Intervention|"GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272938|NCT02738086|BG002|Baseline|Total|Total of all reporting groups
11272939|NCT02738086|FG000|Participant Flow|Early PABC Intervention (Months 1-3)|"GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272940|NCT02738086|FG001|Participant Flow|Wait-List Control Intervention (Months 4-6)|"GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272941|NCT02738086|OG000|Outcome|Early PABC Intervention|"GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272942|NCT02738086|OG001|Outcome|GROUP 2: Wait-List Control Intervention|"GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272943|NCT02738086|OG000|Outcome|PABC Intervention|"Groups 1 and 2~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272944|NCT02738086|EG000|Reported Event|GROUP 1: Early PABC Intervention (Months 1-3)|"GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272945|NCT02738086|EG001|Reported Event|GROUP 1: No Contact Phase (Months 4-6)|GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
11272946|NCT02738086|EG002|Reported Event|GROUP 2: PABC Attention Control (Months 1-3)|GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
11272947|NCT02738086|EG003|Reported Event|GROUP 2: PABC Intervention (Months 4-6)|"GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.~Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning."
11272948|NCT02738138|BG000|Baseline|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
11272949|NCT02738138|BG001|Baseline|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
11272950|NCT02738138|BG002|Baseline|Total|Total of all reporting groups
11272951|NCT02738138|FG000|Participant Flow|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
11272952|NCT02738138|FG001|Participant Flow|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
11272953|NCT02738138|OG000|Outcome|ABT-493/ABT-530|HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
11272954|NCT02738138|EG000|Reported Event|ABT-493/ABT-530 for 8 Weeks|HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
11272955|NCT02738138|EG001|Reported Event|ABT-493/ABT-530 for 12 Weeks|HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
11272956|NCT02738151|BG000|Baseline|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272957|NCT02738151|BG001|Baseline|Tresiba|Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272958|NCT02738151|BG002|Baseline|Total|Total of all reporting groups
11272959|NCT02738151|FG000|Participant Flow|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272960|NCT02738151|FG001|Participant Flow|Tresiba|Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272961|NCT02738151|OG000|Outcome|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272962|NCT02738151|OG001|Outcome|Tresiba|Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272963|NCT02738151|EG000|Reported Event|Toujeo|Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272964|NCT02738151|EG001|Reported Event|Tresiba|Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
11272965|NCT02738203|BG000|Baseline|Experimental, IUD Insertion Group|"If the subject is assigned to the experimental group (vaginal lidocaine jelly):~She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly"
11272966|NCT02738203|BG001|Baseline|Control, IUD Insertion Group|"If the subject is assigned to the control group (sterile, surgical lubricant jelly):~•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly"
11272967|NCT02738203|BG002|Baseline|Total|Total of all reporting groups
11272968|NCT02738203|FG000|Participant Flow|Experimental, IUD Insertion Group|"If the subject is assigned to the experimental group (vaginal lidocaine jelly):~She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly"
11272969|NCT02738203|FG001|Participant Flow|Control, IUD Insertion Group|"If the subject is assigned to the control group (sterile, surgical lubricant jelly):~•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly"
11272970|NCT02738203|OG000|Outcome|Experimental, IUD Insertion Group|"If the subject is assigned to the experimental group (vaginal lidocaine jelly):~She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly"
11286832|NCT02894502|OG002|Outcome|Control Group|This Arm will receive the standard of care
11272971|NCT02738203|OG001|Outcome|Control, IUD Insertion Group|"If the subject is assigned to the control group (sterile, surgical lubricant jelly):~•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly"
11272972|NCT02738203|EG000|Reported Event|Experimental, IUD Insertion Group|"If the subject is assigned to the experimental group (vaginal lidocaine jelly):~She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly"
11272973|NCT02738203|EG001|Reported Event|Control, IUD Insertion Group|"If the subject is assigned to the control group (sterile, surgical lubricant jelly):~•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.~Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly"
11272974|NCT02738333|BG000|Baseline|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11272975|NCT02738333|BG001|Baseline|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
11272976|NCT02738333|BG002|Baseline|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
11272977|NCT02738333|BG003|Baseline|Total|Total of all reporting groups
11272978|NCT02738333|FG000|Participant Flow|LDV/SOF (Cohort 1)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
11272979|NCT02738333|FG001|Participant Flow|SOF+RBV (Cohort 1)|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
11272980|NCT02738333|FG002|Participant Flow|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
11272981|NCT02738333|OG000|Outcome|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11272982|NCT02738333|OG001|Outcome|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
11272983|NCT02738333|OG002|Outcome|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
11272984|NCT02738333|EG000|Reported Event|LDV/SOF (Cohort 1)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
11272985|NCT02738333|EG001|Reported Event|SOF+RBV (Cohort 1)|SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
11272986|NCT02738333|EG002|Reported Event|LDV/SOF (Cohort 2)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
11272987|NCT02738450|BG000|Baseline|ACI-24 300µg|Cohort 1: Low dose
11272988|NCT02738450|BG001|Baseline|ACI-24 1000µg|Cohort 2: High dose
11272989|NCT02738450|BG002|Baseline|Placebo|Placebo cohort 1 + cohort 2
11272990|NCT02738450|BG003|Baseline|Screen Failure|Screen failure cohort 1 + cohort 2
11272991|NCT02738450|BG004|Baseline|Total|Total of all reporting groups
11272992|NCT02738450|FG000|Participant Flow|ACI-24 300µg|Cohort 1: Low dose
11272993|NCT02738450|FG001|Participant Flow|ACI-24 1000µg|Cohort 2: High dose
11272994|NCT02738450|FG002|Participant Flow|Placebo|Placebo cohort 1 + cohort 2
11272995|NCT02738450|OG000|Outcome|ACI-24 300µg|Cohort 1: Low dose
11272996|NCT02738450|OG001|Outcome|ACI-24 1000µg|Cohort 2: High dose
11272997|NCT02738450|OG002|Outcome|Placebo|Placebo cohort 1 + cohort 2
11272998|NCT02738450|EG000|Reported Event|ACI-24 300µg|Cohort 1: Low dose
11272999|NCT02738450|EG001|Reported Event|ACI-24 1000µg|Cohort 2: High dose
11273000|NCT02738450|EG002|Reported Event|Placebo Cohort 1|Cohort 1: Placebo
11273001|NCT02738450|EG003|Reported Event|Placebo Cohort 2|Cohort 2: Placebo
11273002|NCT02738580|BG000|Baseline|rFSH|"Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.~COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function."
11273003|NCT02738580|BG001|Baseline|HP-HMG|"Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function.~COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function."
11273004|NCT02738580|BG002|Baseline|Total|Total of all reporting groups
11273005|NCT02738580|FG000|Participant Flow|rFSH|"Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.~COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function."
11273006|NCT02738580|FG001|Participant Flow|HP-HMG|"Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function.~COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function."
11273007|NCT02738580|OG000|Outcome|rFSH|"Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.~COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function."
11273008|NCT02738580|OG001|Outcome|HP-HMG|"Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function.~COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function."
10970244|NCT00909545|FG000|Participant Flow|Placebo|4 Placebo to Match (PTM) tablets once daily
11273009|NCT02738580|EG000|Reported Event|rFSH|"Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.~COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function."
11273010|NCT02738580|EG001|Reported Event|HP-HMG|"Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function.~COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function."
11273011|NCT02738775|BG000|Baseline|Cohort 1|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
11273012|NCT02738775|BG001|Baseline|Cohort 2|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
11273013|NCT02738775|BG002|Baseline|Cohort 3|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273014|NCT02738775|BG003|Baseline|Cohort 4|Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273015|NCT02738775|BG004|Baseline|Cohort 5|Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273016|NCT02738775|BG005|Baseline|Cohort 6|Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273017|NCT02738775|BG006|Baseline|Total|Total of all reporting groups
11273018|NCT02738775|FG000|Participant Flow|Cohort 1|Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
11273019|NCT02738775|FG001|Participant Flow|Cohort 2|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
11273020|NCT02738775|FG002|Participant Flow|Cohort 3|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273021|NCT02738775|FG003|Participant Flow|Cohort 4|Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273022|NCT02738775|FG004|Participant Flow|Cohort 5|Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273023|NCT02738775|FG005|Participant Flow|Cohort 6|Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273024|NCT02738775|OG000|Outcome|Cohort 1|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
11273025|NCT02738775|OG001|Outcome|Cohort 2|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
11273026|NCT02738775|OG002|Outcome|Cohort 3|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273027|NCT02738775|OG003|Outcome|Cohort 4|Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273028|NCT02738775|OG004|Outcome|Cohort 5|Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273029|NCT02738775|OG005|Outcome|Cohort 6|Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273030|NCT02738775|OG000|Outcome|Cohort 1|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
11273031|NCT02738775|OG003|Outcome|Cohort 4|Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg / 1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273032|NCT02738775|OG003|Outcome|Cohort 4|Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273033|NCT02738775|EG000|Reported Event|Cohort 1|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
11273034|NCT02738775|EG001|Reported Event|Cohort 2|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
11273035|NCT02738775|EG002|Reported Event|Cohort 3|Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273036|NCT02738775|EG003|Reported Event|Cohort 4|Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273037|NCT02738775|EG004|Reported Event|Cohort 5|Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273038|NCT02738775|EG005|Reported Event|Cohort 6|Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
11273039|NCT02738775|EG006|Reported Event|Placebo|Participant received IV infusion of placebo on Day 1 and Day 15.
11273040|NCT02738801|BG000|Baseline|Placebo QD|Participants received matching oral capsules QD for 12 weeks.
11273041|NCT02738801|BG001|Baseline|GLPG1690 600 mg QD|Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks.
11273042|NCT02738801|BG002|Baseline|Total|Total of all reporting groups
10847375|NCT00283049|BG000|Baseline|SU + TZD + IG|Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
11273043|NCT02738801|FG000|Participant Flow|Placebo Once Daily (QD)|Participants received matching oral capsules QD for 12 weeks.
11273044|NCT02738801|FG001|Participant Flow|GLPG1690 600 mg QD|Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks.
11273045|NCT02738801|OG000|Outcome|Placebo QD|Participants received matching oral capsules QD for 12 weeks.
11273046|NCT02738801|OG001|Outcome|GLPG1690 600 mg QD|Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks.
11273047|NCT02738801|OG000|Outcome|GLPG1690 600 mg QD|Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks.
11273048|NCT02738801|EG000|Reported Event|Placebo QD|Participants received matching oral capsules QD for 12 weeks.
11273049|NCT02738801|EG001|Reported Event|GLPG1690 600 mg QD|Participants received 600 mg GLPG1690, administered as oral capsules QD for 12 weeks.
11273050|NCT02738840|BG000|Baseline|Prodigy MRI or Proclaim Elite MR|"The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).~The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.~MRI scan: MRI scan"
11273051|NCT02738840|FG000|Participant Flow|Prodigy MRI or Proclaim Elite MR|"The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).~The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.~MRI scan: MRI scan"
11273052|NCT02738840|OG000|Outcome|Prodigy MRI or Proclaim Elite MR|"The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).~The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.~MRI scan: MRI scan"
11273053|NCT02738840|EG000|Reported Event|Prodigy MRI or Proclaim Elite MR|"The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip).~The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.~MRI scan: MRI scan"
11273054|NCT02738879|BG000|Baseline|Sitagliptin|Sitagliptin 100 mg, oral, once daily for 30 weeks
11273055|NCT02738879|BG001|Baseline|Placebo|Placebo to sitagliptin 100 mg, oral, once daily for 30 weeks
11273056|NCT02738879|BG002|Baseline|Total|Total of all reporting groups
11273057|NCT02738879|FG000|Participant Flow|Sitagliptin|Sitagliptin 100 mg, oral, once daily for 30 weeks
11273058|NCT02738879|FG001|Participant Flow|Placebo|Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
11273059|NCT02738879|OG000|Outcome|Sitagliptin|Sitagliptin 100 mg, oral, once daily for 30 weeks
11273060|NCT02738879|OG001|Outcome|Placebo|Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
11273061|NCT02738879|EG000|Reported Event|Sitagliptin|Sitagliptin 100 mg, oral, once daily for 30 weeks
11273062|NCT02738879|EG001|Reported Event|Placebo|Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
11273063|NCT02739100|BG000|Baseline|Safety Population|All 13 participants completed every arm of the study. Therefore, the baseline demographic characteristics of the Safety Population as a whole also reflect the characteristics of each arm of the study.
11273064|NCT02739100|FG000|Participant Flow|All Participants|In this cross-over study, all enrolled participants underwent blood sampling over 12 hours for pharmacokinetic (PK) purposes on Day 1. On Days 3, 8, and 10 participants received the following three treatments in a randomized sequence (one treatment per study day): Triferic 2 micromolar via hemodialysate, Triferic 6.6. mg intravenously pre-dialyzer over 3 hours, and Triferic 6.6 mg intravenously post-dialyzer over 3 hours. Blood sampling was conducted over a 12 hour period on each treatment day for PK purposes.
11273065|NCT02739100|OG000|Outcome|Triferic Via Hemodialysate|"Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.~Triferic"
11273066|NCT02739100|OG001|Outcome|Triferic Via IV Infusion Pre-dialyzer|Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer).
11273067|NCT02739100|OG002|Outcome|Triferic IV Infusion Post-dialyzer|Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer).
11273068|NCT02739100|EG000|Reported Event|Triferic Via Hemodialysate|"Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.~Triferic"
11273069|NCT02739100|EG001|Reported Event|Triferic Via IV Infusion Pre-dialyzer|Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer).
11273070|NCT02739100|EG002|Reported Event|Triferic IV Infusion Post-dialyzer|Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer).
11273071|NCT02739269|BG000|Baseline|AMH Group|"Serum AMH measurement~Serum AMH measurement: Serum AMH is measured one month before the IVF treatment"
11273072|NCT02739269|BG001|Baseline|AFC Group|"AFC measurement~AFC measurement: Early follicular phase AFC is measured one month before the IVF treatment"
11273073|NCT02739269|BG002|Baseline|Total|Total of all reporting groups
11273074|NCT02739269|FG000|Participant Flow|AMH Group|"Serum AMH measurement~Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment"
11273075|NCT02739269|FG001|Participant Flow|AFC Group|"AFC measurement~Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment"
11273076|NCT02739269|OG000|Outcome|AMH Group|"Serum AMH measurement~Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment"
11273077|NCT02739269|OG001|Outcome|AFC Group|"AFC measurement~Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment"
11273078|NCT02739269|EG000|Reported Event|AMH Group|"Serum AMH measurement~Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment"
11273079|NCT02739269|EG001|Reported Event|AFC Group|"AFC measurement~Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment"
11273080|NCT02739321|BG000|Baseline|Mattress Technology On|"Intervention: The first two weeks of the study the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. The second two weeks of the study, the mattress technology will be turned off, there will be no intervention.~Sound to Sleep System turned on: The first two weeks of the study the sound to sleep system will be turned on during this arm of the study. The second two weeks of the study, the sound to sleep system will be turned off, there will be no intervention."
11273081|NCT02739321|BG001|Baseline|Mattress Technology Turned Off|"Intervention: The first two weeks of the study there will be no intervention. The second two weeks of the study, the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System: The first two weeks of the study the sound to sleep system will be turned off, there will be no intervention. The second two weeks of the study the sound to sleep system will be turn on."
11273082|NCT02739321|BG002|Baseline|Total|Total of all reporting groups
11273083|NCT02739321|FG000|Participant Flow|Mattress Technology On Then Off|"Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System turned on: For the first two weeks of the study, the sound to sleep system will be turned on during this arm of the study. For the second two weeks of the study, the Sound to Sleep System will be turned off, there is no intervention."
11273084|NCT02739321|FG001|Participant Flow|Mattress Technology Turned Off Then On|"Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.~Sound to Sleep System: For the first two weeks of the study, the Sound to Sleep System is turned off, there is no intervention. For the second two weeks of the study, the Sound to Sleep System is turned on."
11273085|NCT02739321|OG000|Outcome|Mattress Technology On Then Off|"For the first two weeks of the study, the mattress technology is turned on~For the second two weeks of the study, the mattress technology is turned off, there is no intervention.~Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
11273086|NCT02739321|OG001|Outcome|Mattress Technology Off Then On|"For the first two weeks of the study, the mattress technology is turned off, there is no intervention.~For the second two weeks of the study, the mattress technology is turned on~Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
11273087|NCT02739321|OG000|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
11273088|NCT02739321|OG001|Outcome|Mattres Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
11273089|NCT02739321|OG001|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
11273090|NCT02739321|OG000|Outcome|Baseline|All participants before they were randomized into arms
11273091|NCT02739321|OG001|Outcome|Mattress Technology On|Participants who slept with the mattress technology turned on in either the first or second two weeks of the study.
11273092|NCT02739321|OG002|Outcome|Mattress Technology Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
11273093|NCT02739321|OG002|Outcome|Mattress Technonlogy Off|Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
11273094|NCT02739321|OG000|Outcome|Baseline|All participants before they were randomized into arms.
11273095|NCT02739321|OG000|Outcome|All Participants|All participants in both the mattress technology on and off conditions.
11273096|NCT02739321|EG000|Reported Event|Mattress Technology On|"The mattress technology will be turned on.~Intervention: The Sound to Sleep System is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input."
11273097|NCT02739321|EG001|Reported Event|Mattress Technology Off|The mattress technology is turned off, there is no intervention.
11273098|NCT02739360|BG000|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily.
11273099|NCT02739360|FG000|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily.
11273100|NCT02739360|OG000|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily.
11273101|NCT02739360|EG000|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily.
11273102|NCT02739594|BG000|Baseline|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273103|NCT02739594|BG001|Baseline|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273104|NCT02739594|BG002|Baseline|Total|Total of all reporting groups
11273105|NCT02739594|FG000|Participant Flow|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273106|NCT02739594|FG001|Participant Flow|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273107|NCT02739594|OG000|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273108|NCT02739594|OG001|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273109|NCT02739594|OG000|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273110|NCT02739594|EG000|Reported Event|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273111|NCT02739594|EG001|Reported Event|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
11273112|NCT02739698|BG000|Baseline|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273113|NCT02739698|BG001|Baseline|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273114|NCT02739698|BG002|Baseline|Total|Total of all reporting groups
11273115|NCT02739698|FG000|Participant Flow|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273116|NCT02739698|FG001|Participant Flow|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273117|NCT02739698|OG000|Outcome|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy"
11273118|NCT02739698|OG001|Outcome|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy"
11273119|NCT02739698|EG000|Reported Event|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273120|NCT02739698|EG001|Reported Event|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).~Paclitaxel~Radical surgery-peritonectomy (ovarian carcinomatosis)"
11273121|NCT02739789|BG000|Baseline|Sham tDCS|"tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment~Sham tDCS: Sham tDCS"
11273122|NCT02739789|BG001|Baseline|Active tDCS|"tDCS stimulation will be administered over the brain area of interest~tDCS: tDCS"
11273123|NCT02739789|BG002|Baseline|Total|Total of all reporting groups
11273124|NCT02739789|FG000|Participant Flow|Sham tDCS First, Then Active tDCS|"Sham transcranial direct current stimulation (tDCS) on first scan day: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment.~Active tDCS on second scan day: tDCS stimulation will be administered over the brain area of interest."
11273125|NCT02739789|FG001|Participant Flow|Active tDCS First, Then Sham tDCS|"Active tDCS on first scan day: tDCS stimulation will be administered over the brain area of interest.~Sham tDCS on second scan day: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment."
11273126|NCT02739789|OG000|Outcome|Sham tDCS|"tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment~Sham tDCS: Sham tDCS"
11273127|NCT02739789|OG001|Outcome|Active tDCS|"tDCS stimulation will be administered over the brain area of interest~tDCS: tDCS"
11273128|NCT02739789|EG000|Reported Event|Sham tDCS|"Sham tDCS: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment.~All participants received sham tDCS, either on the first or second scan day."
11273129|NCT02739789|EG001|Reported Event|Active tDCS|"Active tDCS: tDCS stimulation will be administered over the brain area of interest.~All participants received active tDCS, either on the first or second scan day."
11273130|NCT02739828|BG000|Baseline|Participants With Hidradenitis Suppurativa|Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
11273131|NCT02739828|FG000|Participant Flow|Participants With Hidradenitis Suppurativa|Participants with moderate or severe hidradenitis suppurativa (HS) treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
11273132|NCT02739828|OG000|Outcome|Participants With Hidradenitis Suppurativa|Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
11273133|NCT02739828|EG000|Reported Event|Patients With Hidradenitis Suppurativa|Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
11273134|NCT02739984|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
11273135|NCT02739984|BG001|Baseline|Evolocumab|Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
11273136|NCT02739984|BG002|Baseline|Total|Total of all reporting groups
11273137|NCT02739984|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
10847376|NCT00283049|BG001|Baseline|MET + TZD + IG|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
10970245|NCT00909545|FG001|Participant Flow|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
10970246|NCT00909545|FG002|Participant Flow|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
10970247|NCT00909545|FG003|Participant Flow|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
11273138|NCT02739984|FG001|Participant Flow|Evolocumab|Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
10970248|NCT00909545|OG000|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
10970249|NCT00909545|OG001|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
10970250|NCT00909545|OG002|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
11273139|NCT02739984|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
11273140|NCT02739984|OG001|Outcome|Evolocumab|Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
11273141|NCT02739984|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
11273142|NCT02739984|EG001|Reported Event|Evolocumab|Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
11273143|NCT02739997|BG000|Baseline|MK-7625A + Metronidazole|MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days.
11273144|NCT02739997|FG000|Participant Flow|MK-7625A + Metronidazole|MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days.
11273145|NCT02739997|OG000|Outcome|MK-7625A + Metronidazole|MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days.
11273146|NCT02739997|EG000|Reported Event|MK-7625A + Metronidazole|MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days.
11273147|NCT02740049|BG000|Baseline|Astma Patients|"Participant undergoes a bronchoscopy to isolate epithelial cells~VR588: Evaluation of the efficacy of a novel JAK/STAT inhibitor, VR588, in isolated epithelial cells from asthma patients"
11273148|NCT02740049|FG000|Participant Flow|Astma Patients|"Participant undergoes a bronchoscopy to isolate epithelial cells~VR588: Evaluation of the efficacy of a novel JAK/STAT inhibitor, VR588, in isolated epithelial cells from asthma patients"
11273149|NCT02740049|OG000|Outcome|Astma Patients|"Participant undergoes a bronchoscopy to isolate epithelial cells~VR588: Evaluation of the efficacy of a novel JAK/STAT inhibitor, VR588, in isolated epithelial cells from asthma patients"
11273150|NCT02740049|EG000|Reported Event|Astma Patients|"Participant undergoes a bronchoscopy to isolate epithelial cells~VR588: Evaluation of the efficacy of a novel JAK/STAT inhibitor, VR588, in isolated epithelial cells from asthma patients"
11273151|NCT02740114|BG000|Baseline|Active Comparator: Bupivacaine Group|Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
11273152|NCT02740114|BG001|Baseline|Experimental: Liposomal Bupivacaine + Bupivacaine Group|Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
11273153|NCT02740114|BG002|Baseline|Total|Total of all reporting groups
11273154|NCT02740114|FG000|Participant Flow|Active Comparator: Bupivacaine Group|Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
11273155|NCT02740114|FG001|Participant Flow|Experimental: Liposomal Bupivacaine + Bupivacaine Group|Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
11273156|NCT02740114|OG000|Outcome|Active Comparator: Bupivacaine Group|Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
11273157|NCT02740114|OG001|Outcome|Experimental: Liposomal Bupivacaine + Bupivacaine Group|Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
11273158|NCT02740114|EG000|Reported Event|Active Comparator: Bupivacaine Group|Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
11273159|NCT02740114|EG001|Reported Event|Experimental: Liposomal Bupivacaine + Bupivacaine Group|Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
11273160|NCT02740153|BG000|Baseline|Urea Cycle Disorder With Liver Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~History of liver transplant"
11273161|NCT02740153|BG001|Baseline|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~No history of liver transplant"
11273162|NCT02740153|BG002|Baseline|Total|Total of all reporting groups
11273163|NCT02740153|FG000|Participant Flow|Urea Cycle Disorder With Liver Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~History of liver transplant.~No intervention given."
11273164|NCT02740153|FG001|Participant Flow|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No history of liver transplant, managed conservatively with medication and diet.~No intervention given."
10970251|NCT00909545|OG003|Outcome|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
11273165|NCT02740153|OG000|Outcome|Urea Cycle Disorder With Liver Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~History of liver transplant"
11273166|NCT02740153|OG001|Outcome|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~No history of liver transplant, UCD managed conservatively through medical management"
11273167|NCT02740153|OG001|Outcome|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~No history of liver transplant. UCD managed conservatively with medical intervention."
11273168|NCT02740153|OG001|Outcome|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~No history of liver transplant. UCD managed conservatively through medical intervention."
11273169|NCT02740153|EG000|Reported Event|Urea Cycle Disorder With Liver Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~History of liver transplant"
11273170|NCT02740153|EG001|Reported Event|Urea Cycle Disorder Without Transplant|"Age 18 and under~Diagnosed with the following Neonatal-type urea cycle disorders: CPSD, OTCD, ASD or ALD, as defined as follows:~No Intervention Given~No history of liver transplant. UCD managed conservatively with medical intervention."
11273171|NCT02740413|BG000|Baseline|Benefix/Refacto/Refacto AF|Participants diagnosed with haemophilia A and B who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273172|NCT02740413|FG000|Participant Flow|Benefix/Refacto/Refacto AF|Participants diagnosed with haemophilia A and B who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273173|NCT02740413|OG000|Outcome|Benefix/Refacto/Refacto AF: Haemophilia A|Participants diagnosed with haemophilia A who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273174|NCT02740413|OG001|Outcome|Benefix/Refacto/Refacto AF: Haemophilia B|Participants diagnosed with haemophilia B who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273175|NCT02740413|OG000|Outcome|Benefix/Refacto/Refacto AF|Participants diagnosed with haemophilia A and B who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273176|NCT02740413|OG000|Outcome|Haemophilia A|Participants with haemophilia A registered in the Malmo Haemophilia Register (MHR) with at least one prescription of BeneFIX and ReFacto/ReFacto AF were observed for 11 years (2005-2015).
11273177|NCT02740413|OG001|Outcome|Haemophilia B|Participants with haemophilia B registered in the Malmo Haemophilia Register (MHR) with at least one prescription of BeneFIX and ReFacto/ReFacto AF were observed for 11 years (2005-2015).
11273178|NCT02740413|EG000|Reported Event|Benefix/Refacto/Refacto AF|Participants diagnosed with haemophilia A and B who were registered in the MHR and had at least one registered prescription of Benefix or Refacto/Refacto AF were included in the study and their data (for the duration of 11 years, i.e. 2005-2015) was retrospectively observed.
11273179|NCT02740478|BG000|Baseline|Reassure 10.5 GHz Sensor Sleep Simulation|"Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate.~Volunteers recruited until there were 20 that completed the study."
11273180|NCT02740478|FG000|Participant Flow|Reassure 10.5 GHz Sensor Sleep Simulation|"Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate.~Volunteers recruited until there were 20 that completed the study."
11273181|NCT02740478|OG000|Outcome|Reassure 10.5 GHz Sensor Sleep Simulation|"Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate.~Volunteers recruited until there were 20 that completed the study."
11273182|NCT02740478|EG000|Reported Event|Reassure 10.5 GHz Sensor Sleep Simulation|"Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate.~Volunteers recruited until there were 20 that completed the study."
11273183|NCT02740504|BG000|Baseline|Respiration Rate Sensor|All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45
11273184|NCT02740504|FG000|Participant Flow|Respiration Rate Sensor|"All 20 subjects. Selected to have a range of ages (18 to 75) and BMI from 18.5 to 45.~Actual:~Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3"
11273185|NCT02740504|OG000|Outcome|Respiration Rate Sensor|"All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45.~Actual:~Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3"
11273186|NCT02740504|EG000|Reported Event|Respiration Rate Sensor|"All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45.~Actual:~Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3"
11273187|NCT02740517|BG000|Baseline|Home User Trial Phase 1 (HUT1)|First phase of the home user trial.
11273188|NCT02740517|BG001|Baseline|Home User Trial Phase 2 (HUT2)|Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.
11273189|NCT02740517|BG002|Baseline|Home User Trial Phase 3 (HUT3)|Third phase of home user trial, testing the final improvements to the device.
11273190|NCT02740517|BG003|Baseline|Total|Total of all reporting groups
11273191|NCT02740517|FG000|Participant Flow|Home User Trial Phase 1 (HUT1)|First phase of the home user trial.
11273192|NCT02740517|FG001|Participant Flow|Home User Trial Phase 2 (HUT2)|Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.
11273193|NCT02740517|FG002|Participant Flow|Home User Trial Phase 3 (HUT3)|Third phase of home user trial, testing the final improvements to the device.
11273194|NCT02740517|OG000|Outcome|Home User Trial Phase 1 (HUT1)|First phase of the home user trial.
11273195|NCT02740517|OG001|Outcome|Home User Trial Phase 2 (HUT2)|Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.
11273196|NCT02740517|OG002|Outcome|Home User Trial Phase 3 (HUT3)|Third phase of home user trial, testing the final improvements to the device.
11273197|NCT02740517|EG000|Reported Event|Home User Trial Phase 1 (HUT1)|First phase of the home user trial.
11273198|NCT02740517|EG001|Reported Event|Home User Trial Phase 2 (HUT2)|Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1.
11273199|NCT02740517|EG002|Reported Event|Home User Trial Phase 3 (HUT3)|Third phase of home user trial, testing the final improvements to the device.
11273200|NCT02740543|BG000|Baseline|Allergic Asthma (AA)|Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
11273201|NCT02740543|BG001|Baseline|Control|No fluticasone propionate HFA was given to participants.
11273202|NCT02740543|BG002|Baseline|Total|Total of all reporting groups
11273203|NCT02740543|FG000|Participant Flow|Allergic Asthma (AA)|Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
11273204|NCT02740543|FG001|Participant Flow|Control|No fluticasone propionate HFA was given to participants.
11273205|NCT02740543|OG000|Outcome|Allergic Asthma (AA)|Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
11273206|NCT02740543|OG001|Outcome|Control|No fluticasone propionate HFA was given to participants.
11273207|NCT02740543|EG000|Reported Event|Allergic Asthma (AA)|Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
11273208|NCT02740543|EG001|Reported Event|Control|Fluticasone propionate HFA was not given to participant
11273209|NCT02740582|BG000|Baseline|Tolcapone First|"Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID~Tolcapone~Placebo"
11273210|NCT02740582|BG001|Baseline|Placebo First|"Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID~Tolcapone~Placebo"
11273211|NCT02740582|BG002|Baseline|Total|Total of all reporting groups
11273212|NCT02740582|FG000|Participant Flow|Tolcapone First|Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
11273213|NCT02740582|FG001|Participant Flow|Placebo First|Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
11273214|NCT02740582|OG000|Outcome|Tolcapone First, Then Placebo|"Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID~Tolcapone~Placebo"
11273215|NCT02740582|OG001|Outcome|Placebo First, Then Tolcapone|"Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID~Tolcapone~Placebo"
11273216|NCT02740582|EG000|Reported Event|Tolcapone|"Adverse Events Groups are being reported per intervention (e.g., Tolcapone and Placebo) rather than based on group in the cross over study. Tolcapone Group here reflect all participants who received Tolcapone during the study, regardless of order."
11273217|NCT02740582|EG001|Reported Event|Placebeo|"Adverse Events Groups are being reported per intervention (e.g., Tolcapone and Placebo) rather than based on group in the cross over study. Placebo Group here reflect all participants who received Placebo during the study, regardless of order."
11273218|NCT02740660|BG000|Baseline|Caffeine 100mg / Albuterol 4mg|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Caffeine 100mg / Albuterol 4mg~Family weight management counseling"
11273219|NCT02740660|BG001|Baseline|Placebo|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Placebo~Family weight management counseling"
11273220|NCT02740660|BG002|Baseline|Total|Total of all reporting groups
11273221|NCT02740660|FG000|Participant Flow|Caffeine 100mg / Albuterol 4mg|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Caffeine 100mg / Albuterol 4mg~Family weight management counseling"
11273222|NCT02740660|FG001|Participant Flow|Placebo|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Placebo~Family weight management counseling"
11273223|NCT02740660|OG000|Outcome|Caffeine 100mg / Albuterol 4mg|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Caffeine 100mg / Albuterol 4mg~Family weight management counseling"
11273224|NCT02740660|OG001|Outcome|Placebo|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Placebo~Family weight management counseling"
11273225|NCT02740660|EG000|Reported Event|Caffeine 100mg / Albuterol 4mg|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Caffeine 100mg / Albuterol 4mg~Family weight management counseling"
11273226|NCT02740660|EG001|Reported Event|Placebo|"One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.~Placebo~Family weight management counseling"
11273227|NCT02740920|BG000|Baseline|Pembrolizumab|"200mg IV Day 1 every 3 weeks.~Pembrolizumab~CT Scan"
11273228|NCT02740920|FG000|Participant Flow|Pembrolizumab|"200mg IV Day 1 every 3 weeks.~Pembrolizumab~CT Scan"
11273229|NCT02740920|OG000|Outcome|Pembrolizumab|"200mg IV Day 1 every 3 weeks.~Pembrolizumab~CT Scan"
11273230|NCT02740920|EG000|Reported Event|Pembrolizumab|"200mg IV Day 1 every 3 weeks.~Pembrolizumab~CT Scan"
11273231|NCT02741076|BG000|Baseline|Structured Discontinuation Opioid Therapy Suboptimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
10970252|NCT00909545|OG003|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
10970253|NCT00909545|EG000|Reported Event|Placebo|4 Placebo to Match (PTM) tablets once daily
11273232|NCT02741076|BG001|Baseline|Continuation of Opioid Therapy Suboptimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273233|NCT02741076|BG002|Baseline|Structured Discontinuation Opioid Therapy Optimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273234|NCT02741076|BG003|Baseline|Continuation of Opioid Therapy Optimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273235|NCT02741076|BG004|Baseline|Total|Total of all reporting groups
11273236|NCT02741076|FG000|Participant Flow|Structured Discontinuation Opioid Therapy Suboptimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER) Suboptimal Responder
11273237|NCT02741076|FG001|Participant Flow|Continuation of Opioid Therapy Suboptimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273238|NCT02741076|FG002|Participant Flow|Structured Discontinuation Opioid Therapy Optimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273239|NCT02741076|FG003|Participant Flow|Continuation of Opioid Therapy Optimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273240|NCT02741076|OG000|Outcome|Structured Discontinuation Opioid Therapy Suboptimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273241|NCT02741076|OG001|Outcome|Continuation of Opioid Therapy Suboptimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273242|NCT02741076|OG002|Outcome|Structured Discontinuation Opioid Therapy Optimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273243|NCT02741076|OG003|Outcome|Continuation of Opioid Therapy Optimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273244|NCT02741076|OG002|Outcome|Structured Discontinuation Opioid Therapy Optimal Responders|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273245|NCT02741076|EG000|Reported Event|Structured Discontinuation Opioid Therapy Suboptimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273246|NCT02741076|EG001|Reported Event|Continuation of Opioid Therapy Suboptimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
11273247|NCT02741076|EG002|Reported Event|Structured Discontinuation Opioid Therapy Optimal Responder|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Respond
11273248|NCT02741076|EG003|Reported Event|Continuation of Opioid Therapy Optimal Responder|Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
11273249|NCT02741284|BG000|Baseline|Room Air|Room air, no mask
11273250|NCT02741284|BG001|Baseline|Oxygen|10L oxygen by nonrebreather mask
11273251|NCT02741284|BG002|Baseline|Total|Total of all reporting groups
11273252|NCT02741284|FG000|Participant Flow|Room Air|Room air, no mask
11273253|NCT02741284|FG001|Participant Flow|Oxygen|10L oxygen by nonrebreather mask
11273254|NCT02741284|OG000|Outcome|Room Air|Room air, no mask
11273255|NCT02741284|OG001|Outcome|Oxygen|10L oxygen by nonrebreather mask
11273256|NCT02741284|OG000|Outcome|No Oxygen|"Room air~Room air"
11273257|NCT02741284|OG001|Outcome|Oxygen|"10L oxygen by nonrebreather mask~10L Oxygen by nonrebreather mask"
11273258|NCT02741284|EG000|Reported Event|Room Air|Room air, no mask
11273259|NCT02741284|EG001|Reported Event|Oxygen|10L oxygen by nonrebreather mask
11273260|NCT02741297|BG000|Baseline|Spinal Cord Stimulation (SCS) System|"Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology~Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology"
11273261|NCT02741297|FG000|Participant Flow|Spinal Cord Stimulation (SCS) System|"Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology~Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology"
11273262|NCT02741297|OG000|Outcome|Spinal Cord Stimulation (SCS) System|"Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology~Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology"
11273263|NCT02741297|EG000|Reported Event|Spinal Cord Stimulation (SCS) System|"Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology~Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology"
11273264|NCT02741310|BG000|Baseline|Group A: Placebo + Sumatriptan|Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
11273265|NCT02741310|BG001|Baseline|Group B: Erenumab + Sumatriptan|Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
10970254|NCT00909545|EG001|Reported Event|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
11273266|NCT02741310|BG002|Baseline|Total|Total of all reporting groups
11273267|NCT02741310|FG000|Participant Flow|Group A: Placebo + Sumatriptan|Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
11273268|NCT02741310|FG001|Participant Flow|Group B: Erenumab + Sumatriptan|Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
11273269|NCT02741310|OG000|Outcome|Sumatriptan Alone|All participants who received placebo and sumatriptan (Group A, Parts 1 and 2 and Group B, Part 1).
11273270|NCT02741310|OG001|Outcome|Erenumab + Sumatriptan|All participants who received erenumab plus sumatriptan (Group B, Part 2)
11273271|NCT02741310|OG000|Outcome|Part 1 Group A: Placebo + Sumatriptan|In Part 1 participants in Group A received a placebo IV infusion on day 1 then 12 mg SC sumatriptan on day 2.
11273272|NCT02741310|OG001|Outcome|Part 1 Group B: Placebo + Sumatriptan|In Part 1 participants in Group B received a placebo IV infusion on day 1 then 12 mg SC sumatriptan on day 2.
11273273|NCT02741310|OG002|Outcome|Part 2 Group A: Placebo + Sumatriptan|In Part 2 participants in Group A received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan on day 5.
11273274|NCT02741310|OG003|Outcome|Part 2 Group B: Erenumab + Sumatriptan|In Part 2 participants in Group B received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan on day 5.
11273275|NCT02741310|OG000|Outcome|Group A: Placebo + Sumatriptan|Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
11273276|NCT02741310|OG001|Outcome|Group B: Erenumab + Sumatriptan|Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
11273277|NCT02741310|EG000|Reported Event|Part 1 Group A: Placebo + Sumatriptan|In Part 1 participants in Group A received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2.
11273278|NCT02741310|EG001|Reported Event|Part 1 Group B: Placebo + Sumatriptan|In Part 1 participants in Group B received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2.
11273279|NCT02741310|EG002|Reported Event|Part 2 Group A: Placebo + Sumatriptan|In Part 2 participants in Group A received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5.
11273280|NCT02741310|EG003|Reported Event|Part 2: Group B: Erenumab + Sumatriptan|In part 2 participants in Group B received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5.
11273281|NCT02741518|BG000|Baseline|Treatment Arm|"The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use~Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated"
11273282|NCT02741518|BG001|Baseline|Placebo Arm|"The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8~Placebo: These are capsules that have no fecal material in them."
11273283|NCT02741518|BG002|Baseline|Total|Total of all reporting groups
11273284|NCT02741518|FG000|Participant Flow|Treatment Arm|"The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use~Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated"
11273285|NCT02741518|FG001|Participant Flow|Placebo Arm|"The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8~Placebo: These are capsules that have no fecal material in them."
11273286|NCT02741518|OG000|Outcome|Treatment Arm|"The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use~Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated"
11273287|NCT02741518|OG001|Outcome|Placebo Arm|"The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8~Placebo: These are capsules that have no fecal material in them."
11273288|NCT02741518|EG000|Reported Event|Treatment Arm|"The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use~Fecal Microbiota Transplantation: This is pre-screened fecal material that has been encapsulated"
11273289|NCT02741518|EG001|Reported Event|Placebo Arm|"The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8~Placebo: These are capsules that have no fecal material in them."
11273290|NCT02741596|BG000|Baseline|Rollover Participants|Participants who rolled from the DX-2930-03 (NCT02586805) study received 300 milligrams (mg) of DX-2930 subcutaneous (SC) injection on Day 0 followed by a second dose after participants reported their first HAE attack and continued to receive repeated SC administrations of 300 mg DX-2930 every 2 weeks (q2wks) throughout the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days were required between subsequent administrations.
11273291|NCT02741596|BG001|Baseline|Non-rollover Participants|Participants who directly entered in to this DX-2930-04 study received 300 mg of DX-2930 SC injection on Day 0 and continued to receive SC administrations of 300 mg DX-2930 every 2 weeks throughout the treatment period (up to 924 days).
11273292|NCT02741596|BG002|Baseline|Total|Total of all reporting groups
11273293|NCT02741596|FG000|Participant Flow|Rollover Participants|Participants who rolled from the DX-2930-03 (NCT02586805) study received 300 milligrams (mg) of DX-2930 subcutaneous (SC) injection on Day 0 followed by a second dose after participants reported their first HAE attack and continued to receive repeated SC administrations of 300 mg DX-2930 every 2 weeks (q2wks) throughout the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days were required between subsequent administrations.
11273294|NCT02741596|FG001|Participant Flow|Non-rollover Participants|Participants who directly entered in to this DX-2930-04 study received 300 mg of DX-2930 SC injection on Day 0 and continued to receive SC administrations of 300 mg DX-2930 every 2 weeks throughout the treatment period (up to 924 days).
11273295|NCT02741596|OG000|Outcome|Rollover Participants|Participants who rolled from the DX-2930-03 (NCT02586805) study received 300 milligrams (mg) of DX-2930 subcutaneous (SC) injection on Day 0 followed by a second dose after participants reported their first HAE attack and continued to receive repeated SC administrations of 300 mg DX-2930 every 2 weeks (q2wks) throughout the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days were required between subsequent administrations.
10970255|NCT00909545|EG002|Reported Event|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
11273296|NCT02741596|OG001|Outcome|Non-rollover Participants|Participants who directly entered in to this DX-2930-04 study received 300 mg of DX-2930 SC injection on Day 0 and continued to receive SC administrations of 300 mg DX-2930 every 2 weeks throughout the treatment period (up to 924 days).
11273297|NCT02741596|EG000|Reported Event|Rollover|Participants who rolled from the DX-2930-03 (NCT02586805) study received 300 milligrams (mg) of DX-2930 subcutaneous (SC) injection on Day 0 followed by a second dose after participants reported their first HAE attack and continued to receive repeated SC administrations of 300 mg DX-2930 every 2 weeks (q2wks) throughout the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days were required between subsequent administrations.
11273298|NCT02741596|EG001|Reported Event|Non-Rollover|Participants who directly entered in to this DX-2930-04 study received 300 mg of DX-2930 SC injection on Day 0 and continued to receive SC administrations of 300 mg DX-2930 every 2 weeks throughout the treatment period (up to 924 days).
11273299|NCT02741635|BG000|Baseline|Toffee Nasal Pillows Mask|"Participants to use nasal pillows mask one night in lab overnight polysomnography.~Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)"
11273300|NCT02741635|FG000|Participant Flow|Toffee Nasal Pillows Mask|"Participants to use nasal pillows mask one night in lab overnight polysomnography.~New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)"
11273301|NCT02741635|OG000|Outcome|Toffee Nasal Pillows Mask|"Participants to use nasal pillows mask one night in lab overnight polysomnography.~New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)"
11273302|NCT02741635|OG000|Outcome|Toffee Nasal Pillows Mask|"Participants to use nasal pillows mask one night in lab overnight polysomnography.~Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)"
11273303|NCT02741635|EG000|Reported Event|Toffee Nasal Pillows Mask|"Participants to use nasal pillows mask one night in lab overnight polysomnography.~Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)"
11273304|NCT02741687|BG000|Baseline|Placebo|Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273305|NCT02741687|BG001|Baseline|Sitagliptin|Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273306|NCT02741687|BG002|Baseline|Total|Total of all reporting groups
11273307|NCT02741687|FG000|Participant Flow|Placebo|Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273308|NCT02741687|FG001|Participant Flow|Sitagliptin|Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273309|NCT02741687|OG000|Outcome|Placebo|Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273310|NCT02741687|OG001|Outcome|Sitagliptin|Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273311|NCT02741687|EG000|Reported Event|Placebo|Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273312|NCT02741687|EG001|Reported Event|Sitagliptin|Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
11273313|NCT02741713|BG000|Baseline|Interscalene Block Plus Sham Block|"Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS Pectoralis block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.~Interscalene Block: An interscalene block will be performed on the subjects.~Sham Block~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection in Sham Block: Lidocaine 1%"
11273314|NCT02741713|BG001|Baseline|Interscalene Plus PECS Blocks|"Twenty patients will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. Intervention subjects will also a PECS Pectoralis II using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.~PECS Pectoralis II Blocks: An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects.~Interscalene Block: An interscalene block will be performed on the subjects. Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine Solution for Injection PECS II Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2 location."
11273315|NCT02741713|BG002|Baseline|Total|Total of all reporting groups
11273316|NCT02741713|FG000|Participant Flow|Interscalene Block Plus Sham Block|"Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS Pectoralis block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.~Interscalene Block: An interscalene block will be performed on the subjects.~Sham Block~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection in Sham Block: Lidocaine 1%"
10970256|NCT00909545|EG003|Reported Event|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
10970257|NCT00909727|BG000|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
11273317|NCT02741713|FG001|Participant Flow|Interscalene Plus PECS Blocks|"Twenty patients will receive an ultrasound guided interscalene nerve block with Solution for Injection for Interscalene Block dosed at the 6th cervical root level, per standard clinical practice. Intervention subjects will also get a PECS Pectoralis 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.~PECS Pectoralis 1 and 2 Blocks: An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects.~Interscalene Block: An interscalene block will be performed on the subjects.~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at PECS II."
11273318|NCT02741713|OG000|Outcome|Interscalene Block Plus Sham Block|"Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS Pectoralis block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.~Interscalene Block: An interscalene block will be performed on the subjects.~Sham Block~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection in Sham Block: Lidocaine 1%"
11273319|NCT02741713|OG001|Outcome|Interscalene Plus PECS Blocks|"Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS Pectoralis 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.~PECS Pectoralis 1 and 2 Blocks: An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects.~Interscalene Block: An interscalene block will be performed on the subjects.~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2"
11273320|NCT02741713|OG000|Outcome|Interscalene Plus PECS Blocks|"Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS Pectoralis 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.~PECS Pectoralis 1 and 2 Blocks: An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects.~Interscalene Block: An interscalene block will be performed on the subjects.~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2"
11273321|NCT02741713|EG000|Reported Event|Interscalene Block Plus Sham Block|"Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS Pectoralis block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.~Interscalene Block: An interscalene block will be performed on the subjects.~Sham Block~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection in Sham Block: Lidocaine 1%"
11273322|NCT02741713|EG001|Reported Event|Interscalene Plus PECS Blocks|"Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS Pectoralis 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.~PECS Pectoralis 1 and 2 Blocks: An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects.~Interscalene Block: An interscalene block will be performed on the subjects.~Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine~Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at t"
11273323|NCT02742077|BG000|Baseline|Robotic-assisted PVI|Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
11273324|NCT02742077|FG000|Participant Flow|Robotic-assisted PVI|Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
11273325|NCT02742077|OG000|Outcome|Robotic-assisted PVI|Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
11273326|NCT02742077|EG000|Reported Event|Robotic-assisted PVI|Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
11273327|NCT02742103|BG000|Baseline|CSL_112|"CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).~CSL_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11273328|NCT02742103|BG001|Baseline|Placebo|"Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11273329|NCT02742103|BG002|Baseline|Total|Total of all reporting groups
10847377|NCT00283049|BG002|Baseline|MET+SU + IG|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
11273330|NCT02742103|FG000|Participant Flow|CSL_112|"CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).~CSL_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11273331|NCT02742103|FG001|Participant Flow|Placebo|"Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11273332|NCT02742103|OG000|Outcome|CSL_112|"CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).~CSL_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11273333|NCT02742103|OG001|Outcome|Placebo|"Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11273334|NCT02742103|EG000|Reported Event|CSL_112|"CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).~CSL_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles."
11273335|NCT02742103|EG001|Reported Event|Placebo|"Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.~Placebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)"
11273336|NCT02742129|BG000|Baseline|AIR001 Crossover to Placebo|"Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001.~Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally to"
11273337|NCT02742129|BG001|Baseline|Placebo Crossover to AIR001|"Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo.~Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally"
11273338|NCT02742129|BG002|Baseline|Total|Total of all reporting groups
11273339|NCT02742129|FG000|Participant Flow|AIR001 Crossover to Placebo|Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001.
11273340|NCT02742129|FG001|Participant Flow|Placebo Crossover to AIR001|Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo.
11273341|NCT02742129|OG000|Outcome|AIR001 Crossover to Placebo|"Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001.~Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally to"
11273342|NCT02742129|OG001|Outcome|Placebo Crossover to AIR001|"Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo.~Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally"
10847378|NCT00283049|BG003|Baseline|Total|Total of all reporting groups
11273343|NCT02742129|OG000|Outcome|AIR001 Crossover to Placebo|Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001.
11273344|NCT02742129|OG001|Outcome|Placebo Crossover to AIR001|Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo.
11273345|NCT02742129|OG000|Outcome|AIR001 Crossover to Placebo|Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001.
11273346|NCT02742129|EG000|Reported Event|AIR001|Time period in which patient received AIR001 plus 2 weeks regardless of study phase.
11273347|NCT02742129|EG001|Reported Event|Placebo|Time period in which patient received placebo plus 2 weeks regardless of study phase.
11273348|NCT02742441|BG000|Baseline|122-0551 Foam|"122-0511 Foam, topically applied twice daily~Intervention: Drug: 122-0551 Foam~122-0551 Foam: Topical Foam containing active drug"
11273349|NCT02742441|BG001|Baseline|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Intervention: Drug: Vehicle Foam~Vehicle Foam: Topical Foam containing no active drug"
11273350|NCT02742441|BG002|Baseline|Total|Total of all reporting groups
11273351|NCT02742441|FG000|Participant Flow|122-0551 Foam|"122-0511 Foam, topically applied twice daily~Intervention: Drug: 122-0551 Foam~122-0551 Foam: Topical Foam containing active drug"
11273352|NCT02742441|FG001|Participant Flow|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Intervention: Drug: Vehicle Foam~Vehicle Foam: Topical Foam containing no active drug"
11273353|NCT02742441|OG000|Outcome|122-0551 Foam|"122-0511 Foam, topically applied twice daily~Intervention: Drug: 122-0551 Foam~122-0551 Foam: Topical Foam containing active drug"
11273354|NCT02742441|OG001|Outcome|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Intervention: Drug: Vehicle Foam~Vehicle Foam: Topical Foam containing no active drug"
11273355|NCT02742441|EG000|Reported Event|122-0551 Foam|"122-0511 Foam, topically applied twice daily~Intervention: Drug: 122-0551 Foam~122-0551 Foam: Topical Foam containing active drug"
11273356|NCT02742441|EG001|Reported Event|Vehicle Foam|"Vehicle Foam, topically applied twice daily~Intervention: Drug: Vehicle Foam~Vehicle Foam: Topical Foam containing no active drug"
11273357|NCT02742519|BG000|Baseline|Part 1 Sequence 1: Ivacaftor First, Then Placebo|Ivacaftor administered every 12 hours for 8 weeks in treatment period 1 followed by placebo matched to Ivacaftor administered every 12 hours for 8 weeks in treatment period 2. Washout period of 8 weeks occurred between treatment period 1 and treatment period 2. For ivacaftor, the dose was either 50 milligram (mg) or 75 mg, as determined by the participant's body weight on Day 1.
11273358|NCT02742519|BG001|Baseline|Part 1 Sequence 2: Placebo First, Then Ivacaftor|Placebo matched to Ivacaftor administered every 12 hours for 8 weeks in treatment period 1 followed by Ivacaftor administered every 12 hours for 8 weeks in treatment period 2. Washout period of 8 weeks occurred between treatment period 1 and treatment period 2. For ivacaftor, the dose was either 50 mg or 75 mg, as determined by the participant's body weight on Day 1.
11273359|NCT02742519|BG002|Baseline|Total|Total of all reporting groups
11273360|NCT02742519|FG000|Participant Flow|Part 1 Sequence 1: Ivacaftor First, Then Placebo|Ivacaftor administered every 12 hours for 8 weeks in treatment period 1 followed by placebo matched to Ivacaftor administered every 12 hours for 8 weeks in treatment period 2. Washout period of 8 weeks occurred between treatment period 1 and treatment period 2. For ivacaftor, the dose was either 50 milligram (mg) or 75 mg, as determined by the participant's body weight on Day 1.
11273361|NCT02742519|FG001|Participant Flow|Part 1 Sequence 2: Placebo First, Then Ivacaftor|Placebo matched to Ivacaftor administered every 12 hours for 8 weeks in treatment period 1 followed by Ivacaftor administered every 12 hours for 8 weeks in treatment period 2. Washout period of 8 weeks occurred between treatment period 1 and treatment period 2. For ivacaftor, the dose was either 50 mg or 75 mg, as determined by the participant's body weight on Day 1.
11273362|NCT02742519|FG002|Participant Flow|Part 2: Ivacaftor|Ivacaftor 50 mg, 75 mg or 150 mg, as determined by the participant's body weight at the beginning of Part 2, administered every 12 hours for up to 32 weeks in open label period.
11273363|NCT02742519|OG000|Outcome|Placebo (Crossover Part)|Placebo matched to Ivacaftor administered orally every 12 hours for 8 weeks in treatment period 1 or treatment period 2.
11273364|NCT02742519|OG001|Outcome|Ivacaftor (Crossover Part)|Ivacaftor administered as determined by the participant's body weight on Day 1 orally every 12 hours for 8 weeks in treatment period 1 or treatment period 2.
11273365|NCT02742519|OG002|Outcome|Ivacaftor (Open Label Part)|Ivacaftor administered as determined by the participant's body weight in the beginning of Part 2 orally every 12 hours in for up to 34 weeks in open label period.
10847379|NCT00283049|FG000|Participant Flow|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
10970258|NCT00909727|BG001|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
10970259|NCT00909727|BG002|Baseline|Total|Total of all reporting groups
11273366|NCT02742519|EG000|Reported Event|Placebo (Crossover Part)|Placebo matched to Ivacaftor administered orally every 12 hours for 8 weeks in treatment period 1 or treatment period 2.
11273367|NCT02742519|EG001|Reported Event|Ivacaftor (Crossover Part)|Ivacaftor administered orally every 12 hours for 8 weeks in treatment period 1 or treatment period 2.
11273368|NCT02742519|EG002|Reported Event|Ivacaftor (Open Label Part)|Ivacaftor administered orally every 12 hours in open label period.
11273369|NCT02742532|BG000|Baseline|Oxytocin|"Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)~Oxytocin: Intranasal oxytocin 40 IU"
11273370|NCT02742532|BG001|Baseline|Placebo|"Intra-nasal saline placebo (5 puffs in each nostril)~Placebo: Intranasal saline solution"
11273371|NCT02742532|BG002|Baseline|Total|Total of all reporting groups
11273372|NCT02742532|FG000|Participant Flow|Oxytocin|"Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)~Oxytocin: Intranasal oxytocin 40 IU"
11273373|NCT02742532|FG001|Participant Flow|Placebo|"Intra-nasal saline placebo (5 puffs in each nostril)~Placebo: Intranasal saline solution"
11273374|NCT02742532|OG000|Outcome|Oxytocin|"Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)~Oxytocin: Intranasal oxytocin 40 IU"
11273375|NCT02742532|OG001|Outcome|Placebo|"Intra-nasal saline placebo (5 puffs in each nostril)~Placebo: Intranasal saline solution"
11273376|NCT02742532|EG000|Reported Event|Oxytocin|"Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)~Oxytocin: Intranasal oxytocin 40 IU"
11273377|NCT02742532|EG001|Reported Event|Placebo|"Intra-nasal saline placebo (5 puffs in each nostril)~Placebo: Intranasal saline solution"
11273378|NCT02742649|BG000|Baseline|Fixed Combination (FC) Ocular Inset|Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
10847380|NCT00283049|FG001|Participant Flow|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
11273379|NCT02742649|BG001|Baseline|Bimatoprost Ocular Insert|Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273380|NCT02742649|BG002|Baseline|Timolol Ocular Insert|Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273381|NCT02742649|BG003|Baseline|Total|Total of all reporting groups
11273382|NCT02742649|FG000|Participant Flow|Washout + Placebo Ocular Insert|During the washout period, participants wore a placebo insert in each eye serving as a trial-wear period for 24 to 48 days.
11273383|NCT02742649|FG001|Participant Flow|Fixed Combination (FC) Ocular Insert|Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
11273384|NCT02742649|FG002|Participant Flow|Bimatoprost Ocular Insert|Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98.
11273385|NCT02742649|FG003|Participant Flow|Timolol Ocular Insert|Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
11273386|NCT02742649|FG004|Participant Flow|Timolol 0.5% Ophthalmic Drops|Following a second washout period, timolol drops, 0.5% solution twice daily in each eye from Day 99 to 112.
11273387|NCT02742649|OG000|Outcome|Fixed Combination (FC) Ocular Insert|Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
11273388|NCT02742649|OG001|Outcome|Bimatoprost Ocular Insert|Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98.
11273389|NCT02742649|OG002|Outcome|Timolol Ocular Insert|Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
11273390|NCT02742649|OG000|Outcome|Fixed Combination (FC) Ocular Insert|Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273391|NCT02742649|OG002|Outcome|Timolol Ocular Insert|Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273392|NCT02742649|OG001|Outcome|Bimatoprost Ocular Insert|Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273393|NCT02742649|EG000|Reported Event|Fixed Combination (FC) Ocular Inset|Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273394|NCT02742649|EG001|Reported Event|Bimatoprost Ocular Insert|Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273395|NCT02742649|EG002|Reported Event|Timolol Ocular Insert|Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
11273396|NCT02742766|BG000|Baseline|Part 1- Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (as either single or multiple doses) along with a 30% fat by calorie meal approximately 2 hours after the morning dose for a single day.
11273397|NCT02742766|BG001|Baseline|Part 1-Cohort A1: GSK3008356 5 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273398|NCT02742766|BG002|Baseline|Part 1-Cohort A2: GSK3008356 10 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273399|NCT02742766|BG003|Baseline|Part 1-Cohort A3: GSK3008356 30 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273400|NCT02742766|BG004|Baseline|Part 1-Cohort A4: GSK3008356 75 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273401|NCT02742766|BG005|Baseline|Part 1-Cohort A5: GSK3008356 200 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273402|NCT02742766|BG006|Baseline|Part 1-Cohort A6: GSK3008356 125 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273403|NCT02742766|BG007|Baseline|Part 1-Cohort A7: GSK3008356 100 mg BID (0 h, 4 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273404|NCT02742766|BG008|Baseline|Part 1-Cohort A8: GSK3008356 100 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273405|NCT02742766|BG009|Baseline|Part 1-Cohort A9: GSK3008356 200 mg Evening Dose|Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled.
11273406|NCT02742766|BG010|Baseline|Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273407|NCT02742766|BG011|Baseline|Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
10847381|NCT00283049|FG002|Participant Flow|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
10970260|NCT00909727|FG000|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
11273408|NCT02742766|BG012|Baseline|Part 2-Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (repeat doses) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273409|NCT02742766|BG013|Baseline|Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273410|NCT02742766|BG014|Baseline|Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273411|NCT02742766|BG015|Baseline|Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273412|NCT02742766|BG016|Baseline|Part 3: Obese Participants Cohort 1|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as morning doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273413|NCT02742766|BG017|Baseline|Part 3: Obese Participants Cohort 2|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273414|NCT02742766|BG018|Baseline|Part 3: Obese Participants Cohort 3|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273415|NCT02742766|BG019|Baseline|Total|Total of all reporting groups
11273416|NCT02742766|FG000|Participant Flow|Part 1- Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (as either single or multiple doses) along with a 30% fat by calorie meal approximately 2 hours after the morning dose for a single day.
11273417|NCT02742766|FG001|Participant Flow|Part 1-Cohort A1: GSK3008356 5 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 milligrams [mg]) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273418|NCT02742766|FG002|Participant Flow|Part 1-Cohort A2: GSK3008356 10 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273419|NCT02742766|FG003|Participant Flow|Part 1-Cohort A3: GSK3008356 30 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273420|NCT02742766|FG004|Participant Flow|Part 1-Cohort A4: GSK3008356 75 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273421|NCT02742766|FG005|Participant Flow|Part 1-Cohort A5: GSK3008356 200 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273422|NCT02742766|FG006|Participant Flow|Part 1-Cohort A6: GSK3008356 125 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273423|NCT02742766|FG007|Participant Flow|Part 1-Cohort A7: GSK3008356 100 mg (0 h, 4 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 hour [h] and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273424|NCT02742766|FG008|Participant Flow|Part 1-Cohort A8: GSK3008356 100 mg (0 h, 16 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273425|NCT02742766|FG009|Participant Flow|Part 1-Cohort A9: GSK3008356 200 mg Evening Dose|Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled.
11273426|NCT02742766|FG010|Participant Flow|Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered once every hour [q1h] for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273427|NCT02742766|FG011|Participant Flow|Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273428|NCT02742766|FG012|Participant Flow|Part 2-Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (repeat doses) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273429|NCT02742766|FG013|Participant Flow|Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets twice-daily (BID) via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273430|NCT02742766|FG014|Participant Flow|Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273431|NCT02742766|FG015|Participant Flow|Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273432|NCT02742766|FG016|Participant Flow|Part 3: Obese Participants Cohort 1|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as morning doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273433|NCT02742766|FG017|Participant Flow|Part 3: Obese Participants Cohort 2|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273434|NCT02742766|FG018|Participant Flow|Part 3: Obese Participants Cohort 3|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273435|NCT02742766|OG000|Outcome|Part 1- Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (as either single or multiple doses) along with a 30% fat by calorie meal approximately 2 hours after the morning dose for a single day.
11273436|NCT02742766|OG001|Outcome|Part 1-Cohort A1: GSK3008356 5 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273437|NCT02742766|OG002|Outcome|Part 1-Cohort A2: GSK3008356 10 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273438|NCT02742766|OG003|Outcome|Part 1-Cohort A3: GSK3008356 30 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
10970261|NCT00909727|FG001|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
11214619|NCT02293512|OG000|Outcome|Coping Effectiveness Training (CET)|"A 3-session intervention to facilitate coping strategies among individuals with tinnitus.~Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not."
11214620|NCT02293512|OG001|Outcome|Cognitive-behavioral Therapy (CBT)|"A 3-session intervention to reduce negative affectivity triggered by tinnitus.~Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal."
11214621|NCT02293512|OG002|Outcome|Acceptance and Commitment Therapy|"A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus.~Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values."
11214622|NCT02293512|OG003|Outcome|Wait-list Control Group|No intervention. This is a 'usual care' group.
11214623|NCT02293512|EG000|Reported Event|Coping Effectiveness Training (CET)|"A 3-session intervention to facilitate coping strategies among individuals with tinnitus.~Coping Effectiveness Training for tinnitus: A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not."
11214624|NCT02293512|EG001|Reported Event|Cognitive-behavioral Therapy (CBT)|"A 3-session intervention to reduce negative affectivity triggered by tinnitus.~Cognitive-behavioral therapy (CBT): CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal."
11214625|NCT02293512|EG002|Reported Event|Acceptance and Commitment Therapy|"A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus.~Acceptance and Commitment Therapy for tinnitus: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values."
11214626|NCT02293512|EG003|Reported Event|Wait-list Control Group|No intervention. This is a 'usual care' group.
11214627|NCT02293538|BG000|Baseline|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214628|NCT02293538|BG001|Baseline|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214629|NCT02293538|BG002|Baseline|Total|Total of all reporting groups
11214630|NCT02293538|FG000|Participant Flow|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214631|NCT02293538|FG001|Participant Flow|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214632|NCT02293538|OG000|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214633|NCT02293538|OG001|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214634|NCT02293538|OG000|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214635|NCT02293538|EG000|Reported Event|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214636|NCT02293538|EG001|Reported Event|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
11214637|NCT02293798|BG000|Baseline|SERI|"Subjects receiving SERI for mastopexy~silk surgical scaffold: surgical implant"
11214638|NCT02293798|FG000|Participant Flow|SERI|"Subjects receiving SERI for mastopexy~silk surgical scaffold: surgical implant"
11214639|NCT02293798|OG000|Outcome|SERI|"Subjects receiving SERI for mastopexy~silk surgical scaffold: surgical implant"
11214640|NCT02293798|EG000|Reported Event|SERI|"Subjects receiving SERI for mastopexy~silk surgical scaffold: surgical implant"
11214641|NCT02293837|BG000|Baseline|Tocilizumab (TCZ) in Pediatric Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pediatric participants were 6 to 17 years old inclusive.
11214642|NCT02293837|BG001|Baseline|Placebo in Pediatric Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pediatric participants were 6 to 17 years old inclusive.
11214643|NCT02293837|BG002|Baseline|Tocilizumab (TCZ) in Adult Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Adult participants were 18 to 45 years old inclusive.
11214644|NCT02293837|BG003|Baseline|Placebo in Adult Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Adult participants were 18 to 45 years old inclusive.
11214645|NCT02293837|BG004|Baseline|Total|Total of all reporting groups
11214646|NCT02293837|FG000|Participant Flow|Tocilizumab (TCZ) in Pediatric Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pediatric participants were 6 to 17 years old inclusive.
11273439|NCT02742766|OG004|Outcome|Part 1-Cohort A4: GSK3008356 75 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273440|NCT02742766|OG005|Outcome|Part 1-Cohort A5: GSK3008356 200 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273441|NCT02742766|OG006|Outcome|Part 1-Cohort A6: GSK3008356 125 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273442|NCT02742766|OG007|Outcome|Part 1-Cohort A7: GSK3008356 100 mg (0 h, 4 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273443|NCT02742766|OG008|Outcome|Part 1-Cohort A8: GSK3008356 100 mg (0 h, 16 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273444|NCT02742766|OG009|Outcome|Part 1-Cohort A9: GSK3008356 200 mg Evening Dose|Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled.
11273445|NCT02742766|OG010|Outcome|Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273446|NCT02742766|OG011|Outcome|Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273447|NCT02742766|OG000|Outcome|Part 2-Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (repeat doses) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273448|NCT02742766|OG001|Outcome|Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273449|NCT02742766|OG002|Outcome|Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273450|NCT02742766|OG003|Outcome|Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
10847382|NCT00283049|OG000|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
11273451|NCT02742766|OG000|Outcome|Part 3: Obese Participants Cohort 1|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as morning doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273452|NCT02742766|OG001|Outcome|Part 3: Obese Participants Cohort 2|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273453|NCT02742766|OG002|Outcome|Part 3: Obese Participants Cohort 3|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273454|NCT02742766|OG000|Outcome|Part 1-Cohort A1: GSK3008356 5 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273455|NCT02742766|OG001|Outcome|Part 1-Cohort A2: GSK3008356 10 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273456|NCT02742766|OG002|Outcome|Part 1-Cohort A3: GSK3008356 30 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273457|NCT02742766|OG003|Outcome|Part 1-Cohort A4: GSK3008356 75 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273458|NCT02742766|OG004|Outcome|Part 1-Cohort A5: GSK3008356 200 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273459|NCT02742766|OG005|Outcome|Part 1-Cohort A6: GSK3008356 125 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273460|NCT02742766|OG006|Outcome|Part 1-Cohort A7: GSK3008356 100 mg (0 h, 4 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273461|NCT02742766|OG007|Outcome|Part 1-Cohort A8: GSK3008356 100 mg (0 h, 16 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273462|NCT02742766|OG008|Outcome|Part 1-Cohort A9: GSK3008356 200 mg Evening Dose|Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled.
11273463|NCT02742766|OG009|Outcome|Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273464|NCT02742766|OG010|Outcome|Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273465|NCT02742766|OG006|Outcome|Part 1-Cohort A7: GSK3008356 100 mg t0, t4|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273466|NCT02742766|OG007|Outcome|Part 1-Cohort A8: GSK3008356 100 mg t0, t16|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273467|NCT02742766|OG000|Outcome|GSK3008356 5 mg, 200 mg, 100 mg 0 h, 4 h and 100 mg 0 h, 16 h|Participants received a single dose of either 5 mg or 200 mg or multiple doses of 100 mg at either 0 h and 4 h or t0 and 16 h via oral route on Day 1 of Part 1.
11273468|NCT02742766|OG000|Outcome|GSK3008356 5 mg and 200 mg|Participants received a single dose of either 5 mg or 200 mg via oral route on Day 1 of Part 1.
11273469|NCT02742766|OG000|Outcome|Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273470|NCT02742766|OG001|Outcome|Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
10970262|NCT00909727|OG000|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
11273471|NCT02742766|OG002|Outcome|Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273472|NCT02742766|OG000|Outcome|GSK3008356 1 mg BID or 3 mg BID or 10 mg BID|Participants received multiple doses of either 1 mg BID or 3 mg BID or 10 mg BID of GSK3008356 via oral route on Day 1 and Day 14 of Part 2.
11273473|NCT02742766|OG000|Outcome|Part 3: Cohort 1 to Cohort 3|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 administered as morning doses.
11273474|NCT02742766|EG000|Reported Event|Part 1- Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (as either single or multiple doses) along with a 30% fat by calorie meal approximately 2 hours after the morning dose for a single day.
11273475|NCT02742766|EG001|Reported Event|Part 1-Cohort A1: GSK3008356 5 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273476|NCT02742766|EG002|Reported Event|Part 1-Cohort A2: GSK3008356 10 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273477|NCT02742766|EG003|Reported Event|Part 1-Cohort A3: GSK3008356 30 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273478|NCT02742766|EG004|Reported Event|Part 1-Cohort A4: GSK3008356 75 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273479|NCT02742766|EG005|Reported Event|Part 1-Cohort A5: GSK3008356 200 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273480|NCT02742766|EG006|Reported Event|Part 1-Cohort A6: GSK3008356 125 mg|Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose.
11273481|NCT02742766|EG007|Reported Event|Part 1-Cohort A7: GSK3008356 100 mg BID (0 h, 4 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273482|NCT02742766|EG008|Reported Event|Part 1-Cohort A8: GSK3008356 100 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day.
11273483|NCT02742766|EG009|Reported Event|Part 1-Cohort A9: GSK3008356 200 mg Evening Dose|Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled.
11273484|NCT02742766|EG010|Reported Event|Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273485|NCT02742766|EG011|Reported Event|Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses|Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day.
11273486|NCT02742766|EG012|Reported Event|Part 2-Placebo|Eligible participants received GSK3008356 matching placebo tablets via oral route (repeat doses) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273487|NCT02742766|EG013|Reported Event|Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273488|NCT02742766|EG014|Reported Event|Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273489|NCT02742766|EG015|Reported Event|Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h)|Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose.
11273490|NCT02742766|EG016|Reported Event|Part 3: Obese Participants Cohort 1|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as morning doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273491|NCT02742766|EG017|Reported Event|Part 3: Obese Participants Cohort 2|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273492|NCT02742766|EG018|Reported Event|Part 3: Obese Participants Cohort 3|Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
11273493|NCT02742818|BG000|Baseline|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
10847383|NCT00283049|OG001|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
10970263|NCT00909727|OG001|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
10970264|NCT00909727|EG000|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
11273494|NCT02742818|BG001|Baseline|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
11273495|NCT02742818|BG002|Baseline|Total|Total of all reporting groups
11273496|NCT02742818|FG000|Participant Flow|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
11273497|NCT02742818|FG001|Participant Flow|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
11273498|NCT02742818|OG000|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
11273499|NCT02742818|OG001|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
11273500|NCT02742818|OG000|Outcome|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
11273501|NCT02742818|OG001|Outcome|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
11273502|NCT02742818|EG000|Reported Event|Upper Body Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~522 upper body blanket, Bair Hugger, 3M"
11273503|NCT02742818|EG001|Reported Event|Underbody Blanket|"Patients undergoing EVAR and LEA will use this type of warming blanket.~635 full access underbody blanket, Bair Hugger, 3M"
11273504|NCT02742987|BG000|Baseline|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273505|NCT02742987|BG001|Baseline|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273506|NCT02742987|BG002|Baseline|Total|Total of all reporting groups
11273507|NCT02742987|FG000|Participant Flow|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273508|NCT02742987|FG001|Participant Flow|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273509|NCT02742987|OG000|Outcome|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273510|NCT02742987|OG001|Outcome|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273511|NCT02742987|EG000|Reported Event|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy~Ticagrelor: Ticagrelor 90 mg twice daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273512|NCT02742987|EG001|Reported Event|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy~Clopidogrel: Clopidogrel 150 mg once daily~Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
11273513|NCT02743078|BG000|Baseline|Bevacizumab and TTFields Therapy|"Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.~Bevacizumab: 10 mg/kg every 2 weeks intravenously over 30 minutes.~TTFields Therapy: Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks."
11273514|NCT02743078|FG000|Participant Flow|Bevacizumab and TTFields Therapy|"Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.~Bevacizumab: 10 mg/kg every 2 weeks intravenously over 30 minutes.~TTFields Therapy: Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks."
11273515|NCT02743078|OG000|Outcome|Bevacizumab and TTFields Therapy|"Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.~Bevacizumab: 10 mg/kg every 2 weeks intravenously over 30 minutes.~TTFields Therapy: Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks."
11273516|NCT02743078|EG000|Reported Event|Bevacizumab and TTFields Therapy|"Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.~Bevacizumab: 10 mg/kg every 2 weeks intravenously over 30 minutes.~TTFields Therapy: Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks."
10970265|NCT00909727|EG001|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
11273517|NCT02743117|BG000|Baseline|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11273518|NCT02743117|BG001|Baseline|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11273519|NCT02743117|BG002|Baseline|Total|Total of all reporting groups
11273520|NCT02743117|FG000|Participant Flow|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11273521|NCT02743117|FG001|Participant Flow|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11273522|NCT02743117|OG000|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11273523|NCT02743117|OG001|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11273524|NCT02743117|EG000|Reported Event|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11273525|NCT02743117|EG001|Reported Event|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11273526|NCT02743221|BG000|Baseline|Trifluridine/Tipiracil + Bevacizumab|"Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.~Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.~Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.~Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion."
11273527|NCT02743221|BG001|Baseline|Capecitabine + Bevacizumab|"Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks~Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion."
11273528|NCT02743221|BG002|Baseline|Total|Total of all reporting groups
11273529|NCT02743221|FG000|Participant Flow|Trifluridine/Tipiracil + Bevacizumab|"Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.~Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.~Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.~Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion."
11273530|NCT02743221|FG001|Participant Flow|Capecitabine + Bevacizumab|"Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks~Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion."
11273531|NCT02743221|OG000|Outcome|Trifluridine/Tipiracil + Bevacizumab|"Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.~Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.~Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.~Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion."
11273532|NCT02743221|OG001|Outcome|Capecitabine + Bevacizumab|"Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks~Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion."
11273533|NCT02743221|EG000|Reported Event|Trifluridine/Tipiracil + Bevacizumab|"Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.~Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.~Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.~Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion."
11273534|NCT02743221|EG001|Reported Event|Capecitabine + Bevacizumab|"Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks~Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion."
11273535|NCT02743312|BG000|Baseline|Torso Weights Then Sham Weights|"No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks.~Participants wear the Fitbit Flex throughout.~Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with actual weights (but the assessors and patients do not know which weights are placed).~Sham Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.~Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device."
11273536|NCT02743312|BG001|Baseline|Sham Weights Then Torso Weights|"No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks.~Participants wear the Fitbit Flex throughout.~Sham Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights (but the assessors and patient do not know which weights are placed).~Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with actual weights.~Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device."
11273537|NCT02743312|BG002|Baseline|Total|Total of all reporting groups
11273538|NCT02743312|FG000|Participant Flow|Torso Weights Then Sham Weights|"No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross over to wear garment with sham weights 2-4 hours daily for 2 weeks.~Participants wear the Fitbit Flex throughout.~Balance-Based Torso-Weighting (WT): Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with actual weights (but assessors and patients are not told which weights are placed).~Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device."
11337661|NCT03590613|FG000|Participant Flow|Treatment Sequence A: PBO TID /60mg TID /120mg TID /240mg TID|Participants in this arm received PBO TID in treatment period (TP) 1, GSK2982772 60 milligram (mg) TID in TP2, GSK2982772 120 mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 and placebo was administered at 0 hour (starting dose), 7 hours (second dose) and 14 hours (third dose) on Day 1 in each TP. Participants had fasted overnight for 8 hours before first dose. Each TP was followed by a washout period of at least 7 days, for each participant.
10847384|NCT00283049|OG002|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
11273539|NCT02743312|FG001|Participant Flow|Sham Weights Then Torso Weights|"No weights are worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights 2-4 hours daily for 2 weeks.~Participants wear the Fitbit Flex throughout.~Sham Weights (SW): Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights (assessors and patients are not told which weights are placed).~Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device."
11273540|NCT02743312|OG000|Outcome|Torso Weights|"Garment with torso weights worn 2-4 hours daily for 2 weeks.~Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss."
11273541|NCT02743312|OG001|Outcome|Sham Weights|"Garment with sham weights worn 2-4 hours daily for 2 weeks.~Sham Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights."
11273542|NCT02743312|OG000|Outcome|Torso Weights|Average change in variable from beginning to end of 2 weeks of torso weights.
11273543|NCT02743312|OG001|Outcome|Sham Weights|Average change in variable from beginning to end of 2 weeks of sham weights.
11273544|NCT02743312|OG000|Outcome|Torso Weights|Garment with torso weights worn 2-4 hours daily for 2 weeks.
11273545|NCT02743312|OG001|Outcome|Sham Weights|Garment with sham weights worn 2-4 hours daily for 2 weeks.
11273546|NCT02743312|OG000|Outcome|Torso Weights|Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
11273547|NCT02743312|OG001|Outcome|No Weights|Vest-like garment is worn for testing during each visit (at 4 weeks, 6 weeks, and 8 weeks) before torso-weights are applied.
10970266|NCT00909779|BG000|Baseline|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11273548|NCT02743312|OG000|Outcome|Torso Weights|From beginning to end of 2 weeks of daily wearing of torso weights.
11273549|NCT02743312|OG001|Outcome|Sham Weights|From beginning to end of 2 weeks of daily wearing of sham weights.
11273550|NCT02743312|EG000|Reported Event|Torso Weights|Garment with torso weights worn 2-4 hours daily for 2 weeks.
11273551|NCT02743312|EG001|Reported Event|Sham Weights|Garment with sham weights worn 2-4 hours daily for 2 weeks.
11273552|NCT02743312|EG002|Reported Event|Pre-weighting (no Weights)|4 week baseline period in which participants wore activity monitor but had no other intervention.
11273553|NCT02743377|BG000|Baseline|Healthy Control|Healthy controls received 11C-(R)-rolipram whole-body and/or brain PET scans
11273554|NCT02743377|BG001|Baseline|Subjects With McCune-Albright Syndrome (MAS)|Subjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans
11273555|NCT02743377|BG002|Baseline|Total|Total of all reporting groups
11273556|NCT02743377|FG000|Participant Flow|Healthy Control|Healthy controls received 11C-(R)-rolipram whole-body and/or brain PET scans
11273557|NCT02743377|FG001|Participant Flow|Subjects With McCune-Albright Syndrome (MAS)|Subjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans
11273558|NCT02743377|OG000|Outcome|Healthy Control|Healthy control received 11C-(R)-rolipram whole-body and/or brain PET scans
11273559|NCT02743377|OG001|Outcome|Subjects With McCune-Albright Syndrome (MAS)|Subjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans
11273560|NCT02743377|OG000|Outcome|Subjects With McCune-Albright Syndrome (MAS)|Subjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans
11273561|NCT02743377|EG000|Reported Event|Healthy Control|Healthy control received 11C-(R)-rolipram whole-body and/or brain PET scans
11273562|NCT02743377|EG001|Reported Event|Subjects With McCune-Albright Syndrome (MAS)|Subjects with McCune-Albright syndrome (MAS) received 11C-(R)-rolipram whole-body and/or brain PET scans
11273563|NCT02743442|BG000|Baseline|Transoral Surgery|The study is a single arm : all patients were treated with da Vinci surgical procedure.
11273564|NCT02743442|FG000|Participant Flow|Transoral Surgery|da Vinci® Si™ single arm
11273565|NCT02743442|OG000|Outcome|Transoral Surgery|Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot
11273566|NCT02743442|EG000|Reported Event|Transoral Surgery|Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot
11273567|NCT02743520|BG000|Baseline|Cardiac Event Monitor|"Participants will under go evaluation with a two week cardiac event monitor.~The Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings."
11273568|NCT02743520|FG000|Participant Flow|Cardiac Event Monitor|"Participants will under go evaluation with a two week cardiac event monitor.~The Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings."
11273569|NCT02743520|OG000|Outcome|Cardiac Event Monitor|"Participants will under go evaluation with a two week cardiac event monitor.~The Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings."
11273570|NCT02743520|EG000|Reported Event|Cardiac Event Monitor|"Participants will under go evaluation with a two week cardiac event monitor.~The Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings."
11273571|NCT02743702|BG000|Baseline|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
11273572|NCT02743702|BG001|Baseline|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
11273573|NCT02743702|BG002|Baseline|Total|Total of all reporting groups
11273574|NCT02743702|FG000|Participant Flow|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
11273575|NCT02743702|FG001|Participant Flow|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
11273576|NCT02743702|OG000|Outcome|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
11273577|NCT02743702|OG001|Outcome|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
11273578|NCT02743702|EG000|Reported Event|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
11273579|NCT02743702|EG001|Reported Event|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
10847385|NCT00283049|EG000|Reported Event|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
11273580|NCT02743780|BG000|Baseline|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
11273581|NCT02743780|BG001|Baseline|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
11273582|NCT02743780|BG002|Baseline|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
11273583|NCT02743780|BG003|Baseline|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
11273584|NCT02743780|BG004|Baseline|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
11273585|NCT02743780|BG005|Baseline|Total|Total of all reporting groups
11273586|NCT02743780|FG000|Participant Flow|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
11273587|NCT02743780|FG001|Participant Flow|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
11273588|NCT02743780|FG002|Participant Flow|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
11273589|NCT02743780|FG003|Participant Flow|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
11273590|NCT02743780|FG004|Participant Flow|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
11273591|NCT02743780|OG000|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
11273592|NCT02743780|OG001|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
11273593|NCT02743780|OG000|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
11273594|NCT02743780|OG001|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
11273595|NCT02743780|OG002|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
11273596|NCT02743780|OG000|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
11273597|NCT02743780|OG001|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
11273598|NCT02743780|OG000|Outcome|MGV354 0.1%|Part 3: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 2, 1 drop in each eye for 7 days
11273599|NCT02743780|EG000|Reported Event|MGV354 0.01% Part 1|1 drop in the study eye
11273600|NCT02743780|EG001|Reported Event|MGV354 0.03% Part 1|1 drop in the study eye
11273601|NCT02743780|EG002|Reported Event|MGV354 0.1% Part 1|1 drop in the study eye
11273602|NCT02743780|EG003|Reported Event|MGV354 0.3% Part 1|1 drop in the study eye
11273603|NCT02743780|EG004|Reported Event|Placebo Part 1|1 drop in the study eye
11273604|NCT02743780|EG005|Reported Event|MGV354 0.03% Part 2|1 drop in each eye for 7 days
11273605|NCT02743780|EG006|Reported Event|MGV354 0.1% Part 2|1 drop in each eye for 7 days
11273606|NCT02743780|EG007|Reported Event|Placebo Part 2|1 drop in each eye for 7 days
11273607|NCT02743780|EG008|Reported Event|MGV354 0.1% Part 3|1 drop in each eye for 7 days
11273608|NCT02743780|EG009|Reported Event|Placebo Part 3|1 drop in each eye for 7 days
11273609|NCT02743793|BG000|Baseline|Enrolled, Not Eligible|These participants were consented and enrolled into the study, but did not meet eligibility criteria.
11273610|NCT02743793|BG001|Baseline|Accrued|These participations met all eligibility criteria and completed at least one mechanistic sample collection.
11273611|NCT02743793|BG002|Baseline|Total|Total of all reporting groups
11273612|NCT02743793|FG000|Participant Flow|Enrolled, Not Eligible|These participants were consented and enrolled into the study, but did not meet eligibility criteria.
11273613|NCT02743793|FG001|Participant Flow|Accrued|These participations met all eligibility criteria and completed at least one mechanistic sample collection.
11273614|NCT02743793|OG000|Outcome|Accrued|These participants met all eligibility criteria and completed at least one mechanistic sample collection.
11273615|NCT02743793|EG000|Reported Event|Enrolled, Not Eligible|"These participants were consented and enrolled into the study, but did not meet eligibility criteria. Only adverse events meeting serious criteria were collected for this study. A SAE is defined as any adverse event that meets on or more serious criterion and occurs within 24 hours of the protocol mandated blood draw for research specimens. Those in the Enrolled, Not Eligible Arm/Group did not undergo any protocol mandated blood draws and so no adverse events will be reported for this Arm/Group."
11273616|NCT02743793|EG001|Reported Event|Accrued|"Accrued participations met all eligibility criteria and completed at least one mechanistic sample collection. Only adverse events meeting serious criteria were collected for this study. An SAE is defined as any adverse event that meets one or more serious criterion and occurs within 24 hours of the protocol mandated blood draw for research specimens."
11273617|NCT02743936|BG000|Baseline|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273618|NCT02743936|BG001|Baseline|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273619|NCT02743936|BG002|Baseline|Total|Total of all reporting groups
11273620|NCT02743936|FG000|Participant Flow|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273621|NCT02743936|FG001|Participant Flow|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273622|NCT02743936|OG000|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273623|NCT02743936|OG001|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273624|NCT02743936|EG000|Reported Event|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273625|NCT02743936|EG001|Reported Event|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
11273626|NCT02743949|BG000|Baseline|Esomeprazole 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over-encapsulated tablets, orally, once daily for 4 weeks during the active treatment period.
11273627|NCT02743949|BG001|Baseline|Vonoprazan 20 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period.
11273628|NCT02743949|BG002|Baseline|Vonoprazan 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period.
11273629|NCT02743949|BG003|Baseline|Total|Total of all reporting groups
11273630|NCT02743949|FG000|Participant Flow|Esomeprazole 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over-encapsulated tablets, orally, once daily for 4 weeks during the active treatment period.
11273631|NCT02743949|FG001|Participant Flow|Vonoprazan 20 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period.
11273632|NCT02743949|FG002|Participant Flow|Vonoprazan 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period.
11273633|NCT02743949|OG000|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over-encapsulated tablets, orally, once daily for 4 weeks during the active treatment period.
11273634|NCT02743949|OG001|Outcome|Vonoprazan 20 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period.
11273635|NCT02743949|OG002|Outcome|Vonoprazan 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period.
11273636|NCT02743949|EG000|Reported Event|Esomeprazole 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over-encapsulated tablets, orally, once daily for 4 weeks during the active treatment period.
11273637|NCT02743949|EG001|Reported Event|Vonoprazan 20 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period.
11273638|NCT02743949|EG002|Reported Event|Vonoprazan 40 mg|Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period.
11273639|NCT02743962|BG000|Baseline|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
11273640|NCT02743962|BG001|Baseline|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273641|NCT02743962|BG002|Baseline|Total|Total of all reporting groups
11273642|NCT02743962|FG000|Participant Flow|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
11273643|NCT02743962|FG001|Participant Flow|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273644|NCT02743962|OG000|Outcome|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
11273645|NCT02743962|OG001|Outcome|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273646|NCT02743962|OG000|Outcome|Usual Physiotherapy Treatment Group|"This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
11273647|NCT02743962|OG001|Outcome|Therapeutic Wand Group|"This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273648|NCT02743962|OG000|Outcome|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273649|NCT02743962|EG000|Reported Event|Usual Physiotherapy Treatment Group|"This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period.~Routine physiotherapy control: Provision of routine physiotherapy care as control"
11273650|NCT02743962|EG001|Reported Event|Therapeutic Wand Group|"This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes.~Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study."
11273651|NCT02744066|BG000|Baseline|Phase #1|Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
11273652|NCT02744066|BG001|Baseline|Phase #2|Infants recruited in phase #2 had the device placed for 8 hour periods on three consecutive days with vital signs recorded before, during and after device placements.
11273653|NCT02744066|BG002|Baseline|Total|Total of all reporting groups
11273654|NCT02744066|FG000|Participant Flow|Phase #1|Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
11273655|NCT02744066|FG001|Participant Flow|Phase #2|Infants recruited in phase #2 had the device placed for 8 hour periods on three consecutive days with vital signs recorded before, during and after device placements.
11273656|NCT02744066|OG000|Outcome|Phase #1|Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
11273657|NCT02744066|OG001|Outcome|Phase #2|Infants recruited in phase #2 had the device placed for 8 hour periods on three consecutive days with vital signs recorded before, during and after device placements.
11273658|NCT02744066|OG000|Outcome|Phase #1|Infants recruited in phase #1 had the device placed for 1 hour.
11273659|NCT02744066|OG001|Outcome|Phase #2|Infants recruited in phase #2 had the device placed daily for the same 8 hour periods on three consecutive days.
11273660|NCT02744066|EG000|Reported Event|Phase #1|Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
11273661|NCT02744066|EG001|Reported Event|Phase #2|Infants recruited in phase #2 had the device placed for 8 hour periods on three consecutive days with vital signs recorded before, during and after device placements.
11273662|NCT02744391|BG000|Baseline|L-DOPA|"Patients will receive titration of L-DOPA from 150 mg to 450 mg.~Levodopa"
11273663|NCT02744391|FG000|Participant Flow|L-DOPA|"Patients will receive titration of L-DOPA from 150 mg to 450 mg.~Levodopa"
11273664|NCT02744391|OG000|Outcome|L-DOPA|"Patients will receive titration of L-DOPA from 150 mg to 450 mg.~Levodopa"
11273665|NCT02744391|EG000|Reported Event|L-DOPA|"Patients will receive titration of L-DOPA from 150 mg to 450 mg.~Levodopa"
11273666|NCT02744534|BG000|Baseline|Targeted Biopsy and Template Biopsy|Study participants with abnormal FACBC PET-CT scans received a targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
11273667|NCT02744534|FG000|Participant Flow|Targeted Biopsy and Template Biopsy|Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
11273668|NCT02744534|OG000|Outcome|Targeted Biopsy|Fluciclovine defined targets were biopsied using the 3-D visualization and navigation platform to guide the biopsy needle and record its path.
11273669|NCT02744534|OG001|Outcome|Standard Biopsy|The standard transrectal ultrasound guided biopsy collects 2 cores per region (when possible) from 6 standard regions of the prostate.
11273670|NCT02744534|EG000|Reported Event|Targeted Biopsy|Study participants with abnormal FACBC PET-CT scans received a targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
11273671|NCT02744534|EG001|Reported Event|Template Biopsy|Study participants with abnormal FACBC PET-CT scans received a targeted biopsy and a template (standard of care) biopsy to test for recurrent prostate cancer.
11273672|NCT02744755|BG000|Baseline|GP2017|Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273673|NCT02744755|BG001|Baseline|Humira / Switched GP2017|Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273674|NCT02744755|BG002|Baseline|Total|Total of all reporting groups
11273675|NCT02744755|FG000|Participant Flow|GP2017|Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273676|NCT02744755|FG001|Participant Flow|Humira / Switched GP2017|Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273677|NCT02744755|OG000|Outcome|GP2017|Group 1 received treatment with 40 mg GP2017 in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response continued treatment with 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273678|NCT02744755|OG001|Outcome|Humira / Switched GP2017|Group 2 received treatment with 40 mg Humira in 0.8 mL of solution administered subcutaneously from pre-filled syringes up to 24 weeks (study Period 1) after which patients achieving at least a moderate clinical response were switched to 40mg GP2017 subcutaneous injection up to 46 weeks (study Period 2).
11273679|NCT02744755|EG000|Reported Event|Study Period 1 SP1 SAF GP2017|Study Period 1 SP1 SAF GP2017
11273680|NCT02744755|EG001|Reported Event|Study Period 1 SP1 SAF Humira|Study Period 1 SP1 SAF Humira
11273681|NCT02744755|EG002|Reported Event|Study Period 2 SP2 SAF Continued GP2017|Study Period 2 SP2 SAF Continued GP2017
11273682|NCT02744755|EG003|Reported Event|Study Period 2 SP2 SAF Humira to GP2017|Study Period 2 SP2 SAF Humira to GP2017
11273683|NCT02744755|EG004|Reported Event|Entire Study SP1 SAF GP2017|Entire study SP1 SAF GP2017
11273684|NCT02744755|EG005|Reported Event|Entire Study SP1 SAF Humira/Switched GP2017|Entire study SP1 SAF Humira/Switched GP2017
11273685|NCT02744846|BG000|Baseline|Children From Birth to 5 Years|"Children from birth to 5 years where:~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in either or both of the following age intervals: 4.0 to 5.9 y (age 5 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data~Antibiotics exposure"
11273686|NCT02744846|FG000|Participant Flow|Children From Birth to 10 Years|"Analysis Period 1:~Children from birth to 5 years where:~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~>= 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y (age 5 years)~Analysis Period 2:~Children from birth to 10 years where:~Same criteria as above for the 5 year assessment, and~>= 1 encounter with height and weight measured in the following age intervals: 9.0 to 10.9 y (age 10 years)"
11273687|NCT02744846|OG000|Outcome|Children With no Complex Chronic Conditions|"Children from birth to 5 years where:~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y (age 5 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data~Antibiotics exposure"
11273688|NCT02744846|OG001|Outcome|Children With Complex Chronic Conditions|"Children from birth to 5 years where:~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in the following age intervals: 4.0 to 5.9 y (age 5 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data~Antibiotics exposure"
11273689|NCT02744846|OG000|Outcome|Children With no Complex Chronic Conditions|"Children from birth to 10 years where~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y (age 10 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data"
11273690|NCT02744846|OG001|Outcome|Children With Complex Chronic Conditions|"Children from birth to 10 years where~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y (age 10 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data"
11273691|NCT02744846|EG000|Reported Event|Children From Birth to 5 Years|"Children from birth to 5 years where:~1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in either or both of the following age intervals: 4.0 to 5.9 y (age 5 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data~Antibiotics exposure"
11273692|NCT02744846|EG001|Reported Event|Children From Birth to 10 Years|"Children from birth to 10 years where:~1 or more encounters with length and weight measured in each of the following age intervals: 0-12 m, 12-30 m, and~> 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y (age 10 years), or eligible to be followed to these ages for use in multiple imputation to account for missing data.~Antibiotics exposure"
11273693|NCT02744898|BG000|Baseline|Carboplatin AUC and Abraxane 100mg/m2|Approximately 23 patients will be enrolled in this study at the Laura & Isaac Perlmutter Cancer Center at NYU Langone.There is a total of 17 study visits, including the screening visit to determine if you are eligible to participate. This study will be an out-patient study.
11273694|NCT02744898|FG000|Participant Flow|Carboplatin AUC and Abraxane 100mg/m2|"Carboplatin AUC~Abraxane: 100mg/m2"
11273695|NCT02744898|OG000|Outcome|Carboplatin AUC and Abraxane 100mg/m2|"Carboplatin AUC~Abraxane: 100mg/m2"
11273696|NCT02744898|EG000|Reported Event|Carboplatin AUC and Abraxane 100mg/m2|"Carboplatin AUC~Abraxane: 100mg/m2"
11273697|NCT02745080|BG000|Baseline|Secukinumab 300 mg s.c.|Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
11273698|NCT02745080|BG001|Baseline|Adalimumab 40 mg s.c.|Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
11273699|NCT02745080|BG002|Baseline|Total|Total of all reporting groups
11273700|NCT02745080|FG000|Participant Flow|Secukinumab 300 mg s.c.|Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
11273701|NCT02745080|FG001|Participant Flow|Adalimumab 40 mg s.c.|Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
11273702|NCT02745080|OG000|Outcome|Secukinumab 300 mg s.c.|Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
11273703|NCT02745080|OG001|Outcome|Adalimumab 40 mg s.c.|Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
11273704|NCT02745080|EG000|Reported Event|AIN457 300 mg|Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
11273705|NCT02745080|EG001|Reported Event|Adalimumab 40 mg|Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
11273706|NCT02745080|EG002|Reported Event|Total|Total
11273707|NCT02745119|BG000|Baseline|Lampalizumab Q4W - Treatment-Naive|Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
11273708|NCT02745119|BG001|Baseline|Lampalizumab Q4W - Previously Treated|Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
11273709|NCT02745119|BG002|Baseline|Lampalizumab Q6W - Treatment-Naive|Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273710|NCT02745119|BG003|Baseline|Lampalizumab Q6W - Previously Treated|Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273711|NCT02745119|BG004|Baseline|Total|Total of all reporting groups
11273712|NCT02745119|FG000|Participant Flow|Lampalizumab Q4W - Treatment-Naive|Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
11273713|NCT02745119|FG001|Participant Flow|Lampalizumab Q4W - Previously Treated|Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
11273714|NCT02745119|FG002|Participant Flow|Lampalizumab Q6W - Treatment-Naive|Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273715|NCT02745119|FG003|Participant Flow|Lampalizumab Q6W - Previously Treated|Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273716|NCT02745119|OG000|Outcome|Lampalizumab Q4W - Treatment-Naive|Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
11273717|NCT02745119|OG001|Outcome|Lampalizumab Q4W - Previously Treated|Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
11273718|NCT02745119|OG002|Outcome|Lampalizumab Q6W - Treatment-Naive|Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273719|NCT02745119|OG003|Outcome|Lampalizumab Q6W - Previously Treated|Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273720|NCT02745119|OG004|Outcome|All Participants|All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
11273721|NCT02745119|EG000|Reported Event|Lampalizumab Q4W - Treatment-Naive|Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
11273722|NCT02745119|EG001|Reported Event|Lampalizumab Q4W - Previously Treated|Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
10847386|NCT00283049|EG001|Reported Event|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
11214647|NCT02293837|FG001|Participant Flow|Placebo in Pediatric Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pediatric participants were 6 to 17 years old inclusive.
11214648|NCT02293837|FG002|Participant Flow|Tocilizumab (TCZ) in Adult Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Adult participants were 18 to 45 years old inclusive.
11214649|NCT02293837|FG003|Participant Flow|Placebo in Adult Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Adult participants were 18 to 45 years old inclusive.
11214650|NCT02293837|OG000|Outcome|Tocilizumab (TCZ) in Pediatric Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pediatric participants were 6 to 17 years old inclusive.
11214651|NCT02293837|OG001|Outcome|Placebo in Pediatric Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pediatric participants were 6 to 17 years old inclusive.
11214652|NCT02293837|OG002|Outcome|Tocilizumab (TCZ) in Adult Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Adult participants were 18 to 45 years old inclusive.
11214653|NCT02293837|OG003|Outcome|Placebo in Adult Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Adult participants were 18 to 45 years old inclusive.
11214654|NCT02293837|OG004|Outcome|Tocilizumab (TCZ) in Pooled Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pooled participants are the pediatric and adult participants who received TCZ combined.
11214655|NCT02293837|OG005|Outcome|Placebo in Pooled Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pooled participants are the pediatric and adult participants who received placebo combined.
11214656|NCT02293837|EG000|Reported Event|Tocilizumab (TCZ) in Pediatric Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pediatric participants were 6 to 17 years old inclusive.
11214657|NCT02293837|EG001|Reported Event|Placebo in Pediatric Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pediatric participants were 6 to 17 years old inclusive.
11214658|NCT02293837|EG002|Reported Event|Tocilizumab (TCZ) in Adult Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Adult participants were 18 to 45 years old inclusive.
11214659|NCT02293837|EG003|Reported Event|Placebo in Adult Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Adult participants were 18 to 45 years old inclusive.
11214660|NCT02293837|EG004|Reported Event|Tocilizumab (TCZ) in Pooled Participants|Participants received intravenous (IV) infusions of either 8.0 mg/kg (body weight >=30 kg) or 10.0 mg/kg (body weight <30kg) tocilizumab every 4 weeks for 24 weeks. The dose was capped at 800 mg. Pooled participants are the pediatric and adult participants who received TCZ combined.
11214661|NCT02293837|EG005|Reported Event|Placebo in Pooled Participants|Participants received IV placebo infusions of saline of equal volume and appearance to the treatment. Pooled participants are the pediatric and adult participants who received placebo combined.
11214662|NCT02293863|BG000|Baseline|Placebo + Oseltamivir|Participants received a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214663|NCT02293863|BG001|Baseline|MHAA4549A 3600 mg + Oseltamivir|Participants received a single low intravenous (IV) dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214664|NCT02293863|BG002|Baseline|MHAA4549A 8400 mg + Oseltamivir|Participants received a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214665|NCT02293863|BG003|Baseline|Total|Total of all reporting groups
11214666|NCT02293863|FG000|Participant Flow|Placebo + Oseltamivir|Participants received a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214667|NCT02293863|FG001|Participant Flow|MHAA4549A 3600 mg + Oseltamivir|Participants received a single low intravenous (IV) dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214668|NCT02293863|FG002|Participant Flow|MHAA4549A 8400 mg + Oseltamivir|Participants received a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214669|NCT02293863|OG000|Outcome|Placebo + Oseltamivir|Participants received a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214670|NCT02293863|OG001|Outcome|MHAA4549A 3600 mg + Oseltamivir|Participants received a single low intravenous (IV) dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214671|NCT02293863|OG002|Outcome|MHAA4549A 8400 mg + Oseltamivir|Participants received a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214672|NCT02293863|OG000|Outcome|MHAA4549A 3600 mg + Oseltamivir|Participants received a single low intravenous (IV) dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214673|NCT02293863|OG001|Outcome|MHAA4549A 8400 mg + Oseltamivir|Participants received a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214674|NCT02293863|EG000|Reported Event|Placebo + Oseltamivir|Participants received a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11273723|NCT02745119|EG002|Reported Event|Lampalizumab Q6W - Treatment-Naive|Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273724|NCT02745119|EG003|Reported Event|Lampalizumab Q6W - Previously Treated|Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
11273725|NCT02745119|EG004|Reported Event|All Participants|All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
11273726|NCT02745145|BG000|Baseline|Placebo|Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273727|NCT02745145|BG001|Baseline|Abituzumab 500 Milligrams (mg)|Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273728|NCT02745145|BG002|Baseline|Abituzumab 1500 mg|Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273729|NCT02745145|BG003|Baseline|Total|Total of all reporting groups
11273730|NCT02745145|FG000|Participant Flow|Placebo|Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273731|NCT02745145|FG001|Participant Flow|Abituzumab 500 Milligrams (mg)|Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273732|NCT02745145|FG002|Participant Flow|Abituzumab 1500 mg|Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273733|NCT02745145|OG000|Outcome|Placebo|Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
10970267|NCT00909779|BG001|Baseline|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11273734|NCT02745145|OG001|Outcome|Abituzumab 500 mg|Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273735|NCT02745145|OG002|Outcome|Abituzumab 1500 mg|Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273736|NCT02745145|EG000|Reported Event|Placebo|Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273737|NCT02745145|EG001|Reported Event|Abituzumab 500 Milligrams (mg)|Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273738|NCT02745145|EG002|Reported Event|Abituzumab 1500 mg|Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
11273739|NCT02745353|BG000|Baseline|A- Naloxegol/Standard of Care|"Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.~naloxegol"
11273740|NCT02745353|BG001|Baseline|B - Standard of Care/Naloxegol|"Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.~naloxegol"
11273741|NCT02745353|BG002|Baseline|Total|Total of all reporting groups
11273742|NCT02745353|FG000|Participant Flow|A- Naloxegol/ Standard of Care|"Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.~naloxegol"
11273743|NCT02745353|FG001|Participant Flow|B- Standard of Care/ Naloxegol|"Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.~naloxegol"
11273744|NCT02745353|OG000|Outcome|Arm A (Naloxegol/Standard of Care)|"Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.~naloxegol"
11273745|NCT02745353|OG001|Outcome|Arm B (Standard of Care/ Naloxego)|"Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.~naloxegol"
11273746|NCT02745353|EG000|Reported Event|Naloxegol|All patients who received a single daily dose of 25 mg Naloxegol during the entire study duration
11273747|NCT02745353|EG001|Reported Event|Standard of Care|All patients who received Standard of Care during the entire study duration
11273748|NCT02745392|BG000|Baseline|Placebo|Either single or double patch administration
10970268|NCT00909779|BG002|Baseline|Total|Total of all reporting groups
10970269|NCT00909779|FG000|Participant Flow|Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11273749|NCT02745392|BG001|Baseline|ZP-Zolmitriptan 1 mg|Single 1 mg patch administration
11273750|NCT02745392|BG002|Baseline|ZP-Zolmitriptan 1.9 mg|Single 1.9 mg patch administration
11273751|NCT02745392|BG003|Baseline|ZP-Zolmitriptan 3.8 mg|Double 1.9 mg patch administration
11273752|NCT02745392|BG004|Baseline|Total|Total of all reporting groups
11273753|NCT02745392|FG000|Participant Flow|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
11273754|NCT02745392|FG001|Participant Flow|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273755|NCT02745392|FG002|Participant Flow|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273756|NCT02745392|FG003|Participant Flow|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273757|NCT02745392|OG000|Outcome|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
11273758|NCT02745392|OG001|Outcome|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273759|NCT02745392|OG002|Outcome|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273760|NCT02745392|OG003|Outcome|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273761|NCT02745392|EG000|Reported Event|Placebo|"Placebo (either single or double patch) single administration~Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)"
11273762|NCT02745392|EG001|Reported Event|ZP-Zolmitriptan 1 mg|"ZP-Zolmitriptan 1 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273763|NCT02745392|EG002|Reported Event|ZP-Zolmitriptan 1.9 mg|"ZP-Zolmitriptan 1.9 mg patch single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273764|NCT02745392|EG003|Reported Event|ZP-Zolmitriptan 3.8 mg|"ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration~ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system"
11273765|NCT02745626|BG000|Baseline|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273766|NCT02745626|BG001|Baseline|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273767|NCT02745626|BG002|Baseline|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273768|NCT02745626|BG003|Baseline|Total|Total of all reporting groups
11273769|NCT02745626|FG000|Participant Flow|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273770|NCT02745626|FG001|Participant Flow|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273771|NCT02745626|FG002|Participant Flow|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273772|NCT02745626|OG000|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273773|NCT02745626|OG001|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273774|NCT02745626|OG002|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273775|NCT02745626|EG000|Reported Event|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273776|NCT02745626|EG001|Reported Event|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273777|NCT02745626|EG002|Reported Event|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
11273778|NCT02746107|BG000|Baseline|All Participants|all participants in the study (968)
11273779|NCT02746107|FG000|Participant Flow|All Study Participants|all study participants were 968 (in all arms of this factorial RCT)
11273780|NCT02746107|OG000|Outcome|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams"
11273781|NCT02746107|OG001|Outcome|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams"
11273782|NCT02746107|OG000|Outcome|5 Years Risk Estimation on DA|participants had to prescribe or not OAC after seeing the risk estimated on 5 years
11273783|NCT02746107|OG001|Outcome|1 Year Risk Estimation on DA (CHA2D2S-VASC Score)|participants deciding to prescribe or not OAC after seeing the stroke risk estimation on 1 year (classical CHA2D2S-VASC score)
11273784|NCT02746107|OG000|Outcome|Prescription to Patient|the participant physician were randomized to prescribe OAC to virtual patients
11273785|NCT02746107|OG001|Outcome|Prescription to Physician Himself|the participants had to imagine that they had atrial fibrillation, the risk from the diagram was theirs, and had to decide to take or not the OACs
11273786|NCT02746107|OG000|Outcome|CHA2D2S-VASC Risk Score 1|
11273787|NCT02746107|OG001|Outcome|CHA2D2S-VASC Risk Score 2|
11273788|NCT02746107|OG002|Outcome|CHA2D2S-VASC Risk Score 3|
11273789|NCT02746107|OG003|Outcome|CHA2D2S-VASC Risk Score 4|
11273790|NCT02746107|OG004|Outcome|CHA2D2S-VASC Risk Score 5|
11273791|NCT02746107|EG000|Reported Event|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 400 of 486 (83%)"
11273792|NCT02746107|EG001|Reported Event|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 406 of 482 (83.5%)"
11286833|NCT02894502|EG000|Reported Event|Motivational Interviewing Only for Patients|"In this arm the interventions will be delivered only to patients~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11286834|NCT02894502|EG001|Reported Event|Motivational Interviewing to Patients and Caregivers|"In this arm the interventions will be delivered both to patients and caregivers~Motivational interviewing: The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines."
11286835|NCT02894502|EG002|Reported Event|Control Group|This Group will receive the usual care
11286836|NCT02894840|BG000|Baseline|Inactivated Influenza Vaccine Phase I|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286837|NCT02894840|BG001|Baseline|Placebo Phase I|A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286838|NCT02894840|BG002|Baseline|Inactivated Influenza Vaccine Phase II|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286839|NCT02894840|BG003|Baseline|Placebo Phase II|A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286840|NCT02894840|BG004|Baseline|Total|Total of all reporting groups
11286841|NCT02894840|FG000|Participant Flow|Inactivated Influenza Vaccine Phase I|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286842|NCT02894840|FG001|Participant Flow|Placebo Phase I|A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286843|NCT02894840|FG002|Participant Flow|Inactivated Influenza Vaccine Phase II|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286844|NCT02894840|FG003|Participant Flow|Placebo Phase II|A single dose of placebo (0.9% normal saline solution) was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286845|NCT02894840|OG000|Outcome|Inactivated Influenza Vaccine Phase I|Number of Participants With Adverse Events Phase I: AE/SAE Vaccine group (N=20)
11286846|NCT02894840|OG001|Outcome|Placebo Phase I|Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20)
11286847|NCT02894840|OG002|Outcome|Inactivated Influenza Vaccine Phase II|Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200)
11286848|NCT02894840|OG003|Outcome|Placebo Phase II|Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100)
11286849|NCT02894840|OG000|Outcome|Inactivated Influenza Vaccine Phase I|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
10847387|NCT00283049|EG002|Reported Event|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
10847388|NCT00283062|BG000|Baseline|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11286850|NCT02894840|OG001|Outcome|Placebo Phase I|A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11286851|NCT02894840|OG002|Outcome|Inactivated Influenza Vaccine Phase II|A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11273793|NCT02746406|BG000|Baseline|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
11273794|NCT02746406|FG000|Participant Flow|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
11273795|NCT02746406|OG000|Outcome|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
11273796|NCT02746406|EG000|Reported Event|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
11273797|NCT02746575|BG000|Baseline|Treatment|"Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.~metoprolol"
11273798|NCT02746575|FG000|Participant Flow|Treatment|"Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.~metoprolol"
11273799|NCT02746575|OG000|Outcome|Treatment|"Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.~metoprolol"
11273800|NCT02746575|EG000|Reported Event|Treatment|
11273801|NCT02746627|BG000|Baseline|Education|"Participants receive educational materials in the mail every 2 weeks for 8 weeks.~Education: Educational materials on diabetes management"
11273802|NCT02746627|BG001|Baseline|Positive Affect - Text|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273803|NCT02746627|BG002|Baseline|Positive Affect - Phone|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273804|NCT02746627|BG003|Baseline|Total|Total of all reporting groups
11273805|NCT02746627|FG000|Participant Flow|Education|"Participants receive educational materials in the mail every 2 weeks for 8 weeks.~Education: Educational materials on diabetes management"
11273806|NCT02746627|FG001|Participant Flow|Positive Affect - Text|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273807|NCT02746627|FG002|Participant Flow|Positive Affect - Phone|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273808|NCT02746627|OG000|Outcome|Education|"Participants receive educational materials in the mail every 2 weeks for 8 weeks.~Education: Educational materials on diabetes management"
11273809|NCT02746627|OG001|Outcome|Positive Affect - Text|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273810|NCT02746627|OG002|Outcome|Positive Affect - Phone|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273811|NCT02746627|EG000|Reported Event|Education|"Participants receive educational materials in the mail every 2 weeks for 8 weeks.~Education: Educational materials on diabetes management"
11273812|NCT02746627|EG001|Reported Event|Positive Affect - Text|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273813|NCT02746627|EG002|Reported Event|Positive Affect - Phone|"Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.~Positive Affect: Positive psychology intervention to improve motivation for diabetes management.~Education: Educational materials on diabetes management"
11273814|NCT02746679|BG000|Baseline|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
11273815|NCT02746679|BG001|Baseline|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
11273816|NCT02746679|BG002|Baseline|Total|Total of all reporting groups
11273817|NCT02746679|FG000|Participant Flow|MBSR Group|"The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.~Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this"
11273818|NCT02746679|FG001|Participant Flow|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
11273819|NCT02746679|OG000|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
11273820|NCT02746679|OG001|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
11273821|NCT02746679|EG000|Reported Event|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
11273822|NCT02746679|EG001|Reported Event|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
11273823|NCT02746705|BG000|Baseline|Transcranial Direct Current Stimulation (tDCS)|"Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models~Cognitive Training Program"
11273824|NCT02746705|BG001|Baseline|Sham Transcranial Direct Current Stimulation (tDCS)|"Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.~Cognitive Training Program"
11273825|NCT02746705|BG002|Baseline|Total|Total of all reporting groups
11273826|NCT02746705|FG000|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models~Cognitive Training Program"
11273827|NCT02746705|FG001|Participant Flow|Sham Transcranial Direct Current Stimulation (tDCS)|"Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.~Cognitive Training Program"
11273828|NCT02746705|OG000|Outcome|Transcranial Direct Current Stimulation (tDCS)|"Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models~Cognitive Training Program"
11273829|NCT02746705|OG001|Outcome|Sham Transcranial Direct Current Stimulation (tDCS)|"Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.~Cognitive Training Program"
11273830|NCT02746705|EG000|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models~Cognitive Training Program"
11273831|NCT02746705|EG001|Reported Event|Sham Transcranial Direct Current Stimulation (tDCS)|"Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.~Cognitive Training Program"
11286852|NCT02894840|OG003|Outcome|Placebo Phase II|A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11273832|NCT02746874|BG000|Baseline|Active Group|"Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.~Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning."
11273833|NCT02746874|BG001|Baseline|Placebo Group|"Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.~Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site."
11273834|NCT02746874|BG002|Baseline|Total|Total of all reporting groups
11273835|NCT02746874|FG000|Participant Flow|Active Group|"Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.~Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning."
11273836|NCT02746874|FG001|Participant Flow|Placebo Group|"Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.~Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site."
11273837|NCT02746874|OG000|Outcome|Active Group|"Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.~Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning."
11273838|NCT02746874|OG001|Outcome|Placebo Group|"Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.~Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site."
11273839|NCT02746874|EG000|Reported Event|Active Group|"Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.~Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning."
11273840|NCT02746874|EG001|Reported Event|Placebo Group|"Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.~Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site."
11273841|NCT02746991|BG000|Baseline|Sham Injection|Placebo Injection
11273842|NCT02746991|BG001|Baseline|FAI Insert|FAI Insert Group
11273843|NCT02746991|BG002|Baseline|Total|Total of all reporting groups
11273844|NCT02746991|FG000|Participant Flow|Sham Injection|Placebo Injection
11273845|NCT02746991|FG001|Participant Flow|FAI Insert|Fluocinolone Acetonide Intravitreal (FAI) Insert Group
11273846|NCT02746991|OG000|Outcome|Sham Injection|Placebo Injection
11273847|NCT02746991|OG001|Outcome|FAI Insert|FAI Insert Group
11273848|NCT02746991|OG000|Outcome|Sham Injection|"Sham Injection~Sham Injection: Placebo"
11273849|NCT02746991|OG001|Outcome|FAI Insert|"FAI Insert (0.18 mg fluocinolone acetonide)~FAI Insert: Fluocinolone Acetonide"
11273850|NCT02746991|EG000|Reported Event|Sham Injection|Placebo Injection
11273851|NCT02746991|EG001|Reported Event|FAI Insert|FAI Insert Group
11273852|NCT02747004|BG000|Baseline|150mg Abemaciclib + 20mg Tamoxifen|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
11273853|NCT02747004|BG001|Baseline|150mg Abemaciclib|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
11273854|NCT02747004|BG002|Baseline|200mg Abemaciclib + 2mg Prophylactic Loperamide|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
11273855|NCT02747004|BG003|Baseline|Total|Total of all reporting groups
11273856|NCT02747004|FG000|Participant Flow|150mg Abemaciclib + 20mg Tamoxifen|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
11273857|NCT02747004|FG001|Participant Flow|150mg Abemaciclib|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
11273858|NCT02747004|FG002|Participant Flow|200mg Abemaciclib + 2mg Prophylactic Loperamide|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
11273859|NCT02747004|OG000|Outcome|150mg Abemaciclib + 20mg Tamoxifen|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
11273860|NCT02747004|OG001|Outcome|150mg Abemaciclib|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
11273861|NCT02747004|OG002|Outcome|200mg Abemaciclib + 2mg Prophylactic Loperamide|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
11273862|NCT02747004|EG000|Reported Event|150mg Abemaciclib + 20mg Tamoxifen|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
11273863|NCT02747004|EG001|Reported Event|150mg Abemaciclib|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
11273864|NCT02747004|EG002|Reported Event|200mg Abemaciclib + 2mg Prophylactic Loperamide|Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
11273865|NCT02747043|BG000|Baseline|ABP 798|ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273866|NCT02747043|BG001|Baseline|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273867|NCT02747043|BG002|Baseline|Total|Total of all reporting groups
11273868|NCT02747043|FG000|Participant Flow|ABP 798|ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273869|NCT02747043|FG001|Participant Flow|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273870|NCT02747043|OG000|Outcome|ABP 798|ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273871|NCT02747043|OG001|Outcome|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273872|NCT02747043|EG000|Reported Event|ABP 798|ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273873|NCT02747043|EG001|Reported Event|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
11273874|NCT02747108|BG000|Baseline|Blood Test Group|"Patients will complete an HbA1c test and then receive brief counseling and written information about their test result based on the American Diabetes Association and National Diabetes Prevention Program guidelines.~Blood Test Group Intervention: Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet."
11273875|NCT02747108|BG001|Baseline|Brochure Group (Usual Care)|"Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.~Brochure Group Intervention: Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment."
11273876|NCT02747108|BG002|Baseline|Total|Total of all reporting groups
11273877|NCT02747108|FG000|Participant Flow|Blood Test Group|"Patients will complete an HbA1c test and then receive brief counseling and written information about their test result based on the American Diabetes Association and National Diabetes Prevention Program guidelines.~Blood Test Group Intervention: Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet."
11273878|NCT02747108|FG001|Participant Flow|Brochure Group (Usual Care)|"Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.~Brochure Group Intervention: Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment."
11273879|NCT02747108|OG000|Outcome|Blood Test Group (Normoglycemia)|Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
11286853|NCT02894840|OG003|Outcome|Placebo Phase II|A single dose of placebo (0.9% normal saline solution) was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
11214675|NCT02293863|EG001|Reported Event|MHAA4549A 3600 mg + Oseltamivir|Participants received a single low intravenous (IV) dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214676|NCT02293863|EG002|Reported Event|MHAA4549A 8400 mg + Oseltamivir|Participants received a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
11214677|NCT02293902|BG000|Baseline|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214678|NCT02293902|BG001|Baseline|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
11214679|NCT02293902|BG002|Baseline|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment .
11214680|NCT02293902|BG003|Baseline|Total|Total of all reporting groups
11214681|NCT02293902|FG000|Participant Flow|Placebo|Placebo (for sarilumab) subcutaneous (SC) injection once every 2 weeks (q2w) in combination with methotrexate (MTX) and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214682|NCT02293902|FG001|Participant Flow|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214683|NCT02293902|FG002|Participant Flow|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214684|NCT02293902|FG003|Participant Flow|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214685|NCT02293902|FG004|Participant Flow|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214686|NCT02293902|OG000|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214687|NCT02293902|OG001|Outcome|Sarilumab 150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214688|NCT02293902|OG002|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24. Participants with inadequate response by Week 16 were rescued with open label sarilumab 200 mg q2w treatment.
11214689|NCT02293902|OG000|Outcome|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
11214690|NCT02293902|OG001|Outcome|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
11214691|NCT02293902|OG002|Outcome|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
11214692|NCT02293902|OG003|Outcome|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
11214693|NCT02293902|OG004|Outcome|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
11214694|NCT02293902|OG005|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
11214695|NCT02293902|OG005|Outcome|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
11214696|NCT02293902|EG000|Reported Event|Placebo|Placebo (for sarilumab) SC injection once q2w in combination with MTX and folic acid in double-blind period up to Week 24.
11214697|NCT02293902|EG001|Reported Event|Sarilumab 150 mg/150 mg|Sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
11214698|NCT02293902|EG002|Reported Event|Sarilumab 200 mg/200 mg|Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52.
11273880|NCT02747108|OG001|Outcome|Brochure Group (Usual Care)|"Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.~Brochure Group Intervention: Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment."
11273881|NCT02747108|OG002|Outcome|Blood Test Group (Prediabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
11273882|NCT02747108|OG003|Outcome|Blood Test Group (Diabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
11273883|NCT02747108|OG002|Outcome|Blood Test Group (Prediabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the prediabetes range of n 5.7 - 6.4.
11273884|NCT02747108|OG003|Outcome|Blood Test Group (Diabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the diabetes range of greater than 6.4.
11273885|NCT02747108|OG002|Outcome|Blood Test Group (Prediabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the prediabetes range of 5.7 - 6.4.
11273886|NCT02747108|OG002|Outcome|Blood Test Group (Prediabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 and 6.4.
11273887|NCT02747108|OG003|Outcome|Blood Test Group (Diabetes)|Participants in the Blood Test Group with Baseline HbA1c results in the diabetes range of 6.5 or higher.
11273888|NCT02747108|EG000|Reported Event|Blood Test Group|"Patients will complete an HbA1c test and then receive brief counseling and written information about their test result based on the American Diabetes Association and National Diabetes Prevention Program guidelines.~Blood Test Group Intervention: Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet."
11273889|NCT02747108|EG001|Reported Event|Brochure Group (Usual Care)|"Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.~Brochure Group Intervention: Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment."
11273890|NCT02747186|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Buffered 1% Lidocaine or Non-Buffered 2% Lidocaine
11273891|NCT02747186|FG000|Participant Flow|Buffered 1% Lidocaine, Then Non-Buffered 2% Lidocaine|At each treatment visit, participants were injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal nerves).
11273892|NCT02747186|FG001|Participant Flow|Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine|At each treatment visit, participants were injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal nerves).
11273893|NCT02747186|OG000|Outcome|Buffered 1% Lidocaine|All subjects who received Buffered 1% Lidocaine.
11273894|NCT02747186|OG001|Outcome|Non-Buffered 2% Lidocaine|All subjects who received Non-Buffered 2% Lidocaine.
11273895|NCT02747186|EG000|Reported Event|Buffered 1% Lidocaine|In week One, each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.
11273896|NCT02747186|EG001|Reported Event|Non-Buffered 2% Lidocaine|In week One, each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.
11273897|NCT02747238|BG000|Baseline|Ultrasound|"Ultrasound guided CSE placed~Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273898|NCT02747238|BG001|Baseline|No Ultrasound|"CSE placed using palpation of anatomical landmarks~No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273899|NCT02747238|BG002|Baseline|Total|Total of all reporting groups
10847389|NCT00283062|BG001|Baseline|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11273900|NCT02747238|FG000|Participant Flow|Ultrasound|"Patients that had Ultrasound guided CSE placed~Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.~Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups"
11273901|NCT02747238|FG001|Participant Flow|No Ultrasound|"Patients that had CSE placed using palpation of anatomical landmarks~No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia~Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups"
11286854|NCT02894840|EG000|Reported Event|Inactivated Influenza Vaccine Phase I|Serious Adverse Event Phase I vaccine group N= 20
11273902|NCT02747238|OG000|Outcome|Ultrasound|"Ultrasound guided CSE placed~Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273903|NCT02747238|OG001|Outcome|No Ultrasound|"CSE placed using palpation of anatomical landmarks~No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273904|NCT02747238|EG000|Reported Event|Ultrasound|"Ultrasound guided CSE placed~Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia.~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273905|NCT02747238|EG001|Reported Event|No Ultrasound|"CSE placed using palpation of anatomical landmarks~No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia~Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc"
11273906|NCT02747420|BG000|Baseline|Post Tibial Nerve Stimulation Group (PTNS)|NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
11273907|NCT02747420|BG001|Baseline|Sham Group|"Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The grounding pad from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded."
11273908|NCT02747420|BG002|Baseline|Total|Total of all reporting groups
11273909|NCT02747420|FG000|Participant Flow|Post Tibial Nerve Stimulation Group (PTNS)|NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
11273910|NCT02747420|FG001|Participant Flow|Sham Group|"Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The grounding pad from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded."
11273911|NCT02747420|OG000|Outcome|Post Tibial Nerve Stimulation Group (PTNS)|NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
11273912|NCT02747420|OG001|Outcome|Sham Group|"Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The grounding pad from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded."
11273913|NCT02747420|EG000|Reported Event|Post Tibial Nerve Stimulation Group (PTNS)|NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
11273914|NCT02747420|EG001|Reported Event|Sham Group|"Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The grounding pad from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded."
11273915|NCT02747615|BG000|Baseline|Control Group (n=30)|"The control group, which consisted of 30 patients who were transfused only allogeneic blood.~transfused only allogeneic blood."
11273916|NCT02747615|BG001|Baseline|Preoperative Blood Donation (n=30)|"the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.~transfused pre-operatively donated autologous blood.~intravenous tranexamic acid (TXA) infusion"
11273917|NCT02747615|BG002|Baseline|Total|Total of all reporting groups
11273918|NCT02747615|FG000|Participant Flow|Control Group (n=30)|"The control group, which consisted of 30 patients who were transfused only allogeneic blood.~transfused only allogeneic blood."
11273919|NCT02747615|FG001|Participant Flow|Preoperative Blood Donation (n=30)|"the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.~transfused pre-operatively donated autologous blood.~intravenous tranexamic acid (TXA) infusion"
11273920|NCT02747615|OG000|Outcome|Control Group (n=30)|"The control group, which consisted of 30 patients who were transfused only allogeneic blood.~transfused only allogeneic blood."
11273921|NCT02747615|OG001|Outcome|Preoperative Blood Donation (n=30)|"the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.~transfused pre-operatively donated autologous blood.~intravenous tranexamic acid (TXA) infusion"
11273922|NCT02747615|EG000|Reported Event|Control Group (n=30)|"The control group, which consisted of 30 patients who were transfused only allogeneic blood.~transfused only allogeneic blood."
11273923|NCT02747615|EG001|Reported Event|Preoperative Blood Donation (n=30)|"the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.~transfused pre-operatively donated autologous blood.~intravenous tranexamic acid (TXA) infusion"
11273924|NCT02747628|BG000|Baseline|C Group, (n=20)|"C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273925|NCT02747628|BG001|Baseline|TDN Group, (n=20)|"TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273926|NCT02747628|BG002|Baseline|TDM Group, (n=20)|"TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273927|NCT02747628|BG003|Baseline|Total|Total of all reporting groups
11273928|NCT02747628|FG000|Participant Flow|C Group, (n=20)|"C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273929|NCT02747628|FG001|Participant Flow|TDN Group, (n=20)|"TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273930|NCT02747628|FG002|Participant Flow|TDM Group, (n=20)|"TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273931|NCT02747628|OG000|Outcome|C Group, (n=20)|"C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11286855|NCT02894840|EG001|Reported Event|Placebo Phase I|Serious Adverse Event Phase I placebo group N= 20
11286856|NCT02894840|EG002|Reported Event|Inactivated Influenza Vaccine Phase II|Serious Adverse Event Phase I vaccine group N= 200
11286857|NCT02894840|EG003|Reported Event|Placebo Phase II|Serious Adverse Event Phase I placebo group N= 100
11273932|NCT02747628|OG001|Outcome|TDN Group, (n=20)|"TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273933|NCT02747628|OG002|Outcome|TDM Group, (n=20)|"TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273934|NCT02747628|EG000|Reported Event|C Group, (n=20)|"C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273935|NCT02747628|EG001|Reported Event|TDN Group, (n=20)|"TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273936|NCT02747628|EG002|Reported Event|TDM Group, (n=20)|"TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.~transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded."
11273937|NCT02747875|BG000|Baseline|Control - Fentanyl|"Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273938|NCT02747875|BG001|Baseline|Treatment - Methadone|"Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273939|NCT02747875|BG002|Baseline|Total|Total of all reporting groups
11273940|NCT02747875|FG000|Participant Flow|Control - Fentanyl|"Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11286858|NCT02895035|BG000|Baseline|All Participants|"All Participants were randomized to receive all interventions. Therefore, the baseline characteristics are grouped as all participants"
11286859|NCT02895035|FG000|Participant Flow|Epinephrine (1 Day), Washout (21 Days), Then Omidria (1 Day)|Patients in this arm received epinephrine during the first eye surgery. Patients then waited (washout) 21 days before proceeding with second eye surgery. Patients then received Omidria during the second eye surgery.
11286860|NCT02895035|FG001|Participant Flow|Omidria (1 Day), Washout (21 Days), Then Epinephrine (1 Day)|Patients in this arm received Omidria during the first eye surgery. Patients then waited (washout) 21 days before proceeding with second eye surgery. Patients then received epinephrine during the second eye surgery.
11214699|NCT02293902|EG003|Reported Event|Placebo/Sarilumab 150 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
11214700|NCT02293902|EG004|Reported Event|Placebo/Sarilumab 200 mg|Participants who completed placebo (for sarilumab) treatment up to Week 24, were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in single-blind period up to Week 52.
11214701|NCT02293902|EG005|Reported Event|Sarilumab Rescue|Participants who received either placebo or sarilumab 150 mg or 200 mg and had inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits (at least 4 weeks apart) in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment up to Week 52.
11214702|NCT02293993|BG000|Baseline|Cohort 1|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214703|NCT02293993|BG001|Baseline|Cohort 2|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214704|NCT02293993|BG002|Baseline|Cohort 3|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214705|NCT02293993|BG003|Baseline|Cohort 4|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214706|NCT02293993|BG004|Baseline|Total|Total of all reporting groups
11214707|NCT02293993|FG000|Participant Flow|Cohort 1|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214708|NCT02293993|FG001|Participant Flow|Cohort 2|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214709|NCT02293993|FG002|Participant Flow|Cohort 3|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214710|NCT02293993|FG003|Participant Flow|Cohort 4|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214711|NCT02293993|OG000|Outcome|Cohort 1|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214712|NCT02293993|OG001|Outcome|Cohort 2|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214713|NCT02293993|OG002|Outcome|Cohort 3|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214714|NCT02293993|OG003|Outcome|Cohort 4|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214715|NCT02293993|OG000|Outcome|Cohort 1 (Day 1)|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214716|NCT02293993|OG001|Outcome|Cohort 2 (Day 1)|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214717|NCT02293993|OG002|Outcome|Cohort 3 (Day 1)|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214718|NCT02293993|OG003|Outcome|Cohort 4 (Day 1)|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214719|NCT02293993|OG004|Outcome|Cohort 1 (Day 5)|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214720|NCT02293993|OG005|Outcome|Cohort 2 (Day 5)|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214721|NCT02293993|OG006|Outcome|Cohort 3 (Day 12)|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214722|NCT02293993|OG007|Outcome|Cohort 4 (Day 5)|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214723|NCT02293993|EG000|Reported Event|Cohort 1|SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214724|NCT02293993|EG001|Reported Event|Cohort 2|SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214725|NCT02293993|EG002|Reported Event|Cohort 3|SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
11214726|NCT02293993|EG003|Reported Event|Cohort 4|SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
11214727|NCT02294019|BG000|Baseline|Ibuprofen|All participants who purchased at least 1 carton of study medication.
11214728|NCT02294019|FG000|Participant Flow|Ibuprofen|All participants who purchased at least 1 carton of study medication.
11214729|NCT02294019|OG000|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
11273941|NCT02747875|FG001|Participant Flow|Treatment - Methadone|"Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273942|NCT02747875|OG000|Outcome|Control - Fentanyl|"Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273943|NCT02747875|OG001|Outcome|Treatment - Methadone|"Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273944|NCT02747875|EG000|Reported Event|Control - Fentanyl|"Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273945|NCT02747875|EG001|Reported Event|Treatment - Methadone|"Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.~Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events."
11273946|NCT02747927|BG000|Baseline|Placebo (Part 1)|Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273947|NCT02747927|BG001|Baseline|Tetravalent Dengue Vaccine (TDV) 0.5 mL (Part 1)|TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273948|NCT02747927|BG002|Baseline|Total|Total of all reporting groups
11273949|NCT02747927|FG000|Participant Flow|Placebo (Part 1)|Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273950|NCT02747927|FG001|Participant Flow|Tetravalent Dengue Vaccine (TDV) 0.5 mL (Part 1)|TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273951|NCT02747927|OG000|Outcome|Placebo (Part 1)|Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273952|NCT02747927|OG001|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL (Part 1)|TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11214730|NCT02294019|EG000|Reported Event|Ibuprofen (Safety Population)|Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
11214731|NCT02294058|BG000|Baseline|Interferon Beta-1a|Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.
11214732|NCT02294058|BG001|Baseline|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214733|NCT02294058|BG002|Baseline|Ozanimod 1 mg|Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214734|NCT02294058|BG003|Baseline|Total|Total of all reporting groups
11214735|NCT02294058|FG000|Participant Flow|Interferon Beta-1a|Participants received 30 µg interferon beta-1a (IFN β-1a) by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for at least 12 months.
11214736|NCT02294058|FG001|Participant Flow|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.
11214737|NCT02294058|FG002|Participant Flow|Ozanimod 1 mg|Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.
11214738|NCT02294058|OG000|Outcome|Interferon Beta-1a|Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.
11214739|NCT02294058|OG001|Outcome|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214740|NCT02294058|OG002|Outcome|Ozanimod 1 mg|Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214741|NCT02294058|OG002|Outcome|Ozanimod 1 mg|Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214742|NCT02294058|EG000|Reported Event|Interferon Beta-1a|Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.
11214743|NCT02294058|EG001|Reported Event|Ozanimod 0.5 mg|Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214744|NCT02294058|EG002|Reported Event|Ozanimod 1 mg|Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.
11214745|NCT02294175|BG000|Baseline|Larval Debridement Therapy|"Larval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.~Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm"
11214746|NCT02294175|BG001|Baseline|Sharp Debridement Therapy|"Bedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.~Bedside Sharp Debridement: The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound"
11214747|NCT02294175|BG002|Baseline|Total|Total of all reporting groups
11214748|NCT02294175|FG000|Participant Flow|Larval Debridement Therapy (LDT) - Patients|"Larval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.~Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm"
11214749|NCT02294175|FG001|Participant Flow|Sharp Debridement Therapy (SDT) - Patients|"Bedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.~Bedside Sharp Debridement: The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound"
11214750|NCT02294175|OG000|Outcome|Larval Debridement Therapy|"Larval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.~Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm"
11214751|NCT02294175|OG001|Outcome|Sharp Debridement Therapy|"Bedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.~Bedside Sharp Debridement: The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound"
11214752|NCT02294175|EG000|Reported Event|Larval Debridement Therapy|"Larval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.~Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm"
11273953|NCT02747927|EG000|Reported Event|Placebo (Part 1)|Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273954|NCT02747927|EG001|Reported Event|Tetravalent Dengue Vaccine (TDV) 0.5 mL (Part 1)|TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
11273955|NCT02748070|BG000|Baseline|Prednisone|Participants received oral prednisone taper for 12 days postoperatively.
11273956|NCT02748070|BG001|Baseline|Placebo|Participants received oral placebo for 12 days postoperatively.
11273957|NCT02748070|BG002|Baseline|Total|Total of all reporting groups
11273958|NCT02748070|FG000|Participant Flow|Prednisone|Participants received oral prednisone taper for 12 days postoperatively.
11273959|NCT02748070|FG001|Participant Flow|Placebo|Participants received oral placebo for 12 days postoperatively.
11273960|NCT02748070|OG000|Outcome|Prednisone|Participants received oral prednisone taper for 12 days postoperatively.
11273961|NCT02748070|OG001|Outcome|Placebo|Participants received oral placebo for 12 days postoperatively.
11273962|NCT02748070|EG000|Reported Event|Prednisone|Participants received oral prednisone taper for 12 days postoperatively.
11273963|NCT02748070|EG001|Reported Event|Placebo|Participants received oral placebo for 12 days postoperatively.
11273964|NCT02748096|BG000|Baseline|Patient Specific Instrumentation|"Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation.~Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee)."
11273965|NCT02748096|BG001|Baseline|Conventional Instrumentation|"Patients undergoing unicompartmental knee replacement using standard instrumentation.~Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments."
11273966|NCT02748096|BG002|Baseline|Total|Total of all reporting groups
11273967|NCT02748096|FG000|Participant Flow|Patient Specific Instrumentation|"Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation.~Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee)."
11273968|NCT02748096|FG001|Participant Flow|Conventional Instrumentation|"Patients undergoing unicompartmental knee replacement using standard instrumentation.~Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments."
11273969|NCT02748096|OG000|Outcome|Patient Specific Instrumentation|"Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation.~Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee)."
11273970|NCT02748096|OG001|Outcome|Conventional Instrumentation|"Patients undergoing unicompartmental knee replacement using standard instrumentation.~Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments."
11273971|NCT02748096|EG000|Reported Event|Patient Specific Instrumentation|"Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation.~Patient Specific Instrumentation: Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee)."
11273972|NCT02748096|EG001|Reported Event|Conventional Instrumentation|"Patients undergoing unicompartmental knee replacement using standard instrumentation.~Conventional Instrumentation: Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments."
11273973|NCT02748213|BG000|Baseline|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
11273974|NCT02748213|BG001|Baseline|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
11273975|NCT02748213|BG002|Baseline|Total|Total of all reporting groups
11273976|NCT02748213|FG000|Participant Flow|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
11273977|NCT02748213|FG001|Participant Flow|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
11273978|NCT02748213|OG000|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
11273979|NCT02748213|OG001|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
11273980|NCT02748213|EG000|Reported Event|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
11273981|NCT02748213|EG001|Reported Event|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
11273982|NCT02748317|BG000|Baseline|Adults With Spinal Cord Injury, Spina Bifida or MS|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273983|NCT02748317|FG000|Participant Flow|Adults With Spinal Cord Injury, Spina Bifida or MS|Lactobacillus instillation: During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273984|NCT02748317|OG000|Outcome|Adults With Spinal Cord Injury, Spina Bifida or MS|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273985|NCT02748317|EG000|Reported Event|Adults With Spinal Cord Injury, Spina Bifida or MS|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273986|NCT02748356|BG000|Baseline|Individuals With Spina Bifida or Spinal Cord Injury|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273987|NCT02748356|FG000|Participant Flow|Individuals With Spina Bifida or Spinal Cord Injury|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273988|NCT02748356|OG000|Outcome|Individuals With Spina Bifida or Spinal Cord Injury|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273989|NCT02748356|EG000|Reported Event|Individuals With Spina Bifida or Spinal Cord Injury|Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
11273990|NCT02748512|BG000|Baseline|FAI Insert Administered Using the Mk II Inserter|"The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.~FAI Insert administered using the Mk II inserter"
11273991|NCT02748512|BG001|Baseline|FAI Insert Administered Using the Mk I Inserter|"The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.~FAI Insert administered using the Mk I inserter"
11273992|NCT02748512|BG002|Baseline|Total|Total of all reporting groups
11273993|NCT02748512|FG000|Participant Flow|Mk II Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter
11273994|NCT02748512|FG001|Participant Flow|Mk I Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
11273995|NCT02748512|OG000|Outcome|Mk II Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter
11273996|NCT02748512|OG001|Outcome|Mk I Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
11273997|NCT02748512|EG000|Reported Event|Mk II Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk II inserter
11273998|NCT02748512|EG001|Reported Event|Mk I Inserter|Fluocinolone Acetonide Intravitreal (FAI) Insert, administered using the Mk I inserter
11273999|NCT02748525|BG000|Baseline|CCK Then Milk|"CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.~CCK: CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.~Milk: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low."
11274000|NCT02748525|FG000|Participant Flow|CCK Then Milk|"cholecystokinin (CCK) administered and Hepatobiliary imaging (HIDA) scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.~CCK: CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.~Milk: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low."
11274001|NCT02748525|OG000|Outcome|CCK Then Milk|"CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.~CCK: CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.~Milk: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low."
11274002|NCT02748525|EG000|Reported Event|CCK Then Milk|"CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.~CCK: CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.~Milk: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low."
11274003|NCT02748694|BG000|Baseline|Part 1 (SRD): Placebo Cohorts 1-5|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274004|NCT02748694|BG001|Baseline|Part 1 (SRD): Cohort 1: TAK-041 5/20 mg|TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.
11274005|NCT02748694|BG002|Baseline|Part 1 (SRD): Cohort 2: TAK-041 10/40 mg|TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.
11274006|NCT02748694|BG003|Baseline|Part 1 (SRD): Cohort 3: TAK-041 80 mg|TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274007|NCT02748694|BG004|Baseline|Part 1 (SRD): Cohort 4: TAK-041 120 mg|TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274008|NCT02748694|BG005|Baseline|Part 1 (SRD): Cohort 5: TAK-041 160 mg|TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274009|NCT02748694|BG006|Baseline|Part 2 (MRD): Placebo Cohorts 1-4|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.
11274010|NCT02748694|BG007|Baseline|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274011|NCT02748694|BG008|Baseline|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274012|NCT02748694|BG009|Baseline|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274013|NCT02748694|BG010|Baseline|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274014|NCT02748694|BG011|Baseline|Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A|TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.
11274015|NCT02748694|BG012|Baseline|Part 3: RBA/Food Effect: Regimen B|TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.
11274016|NCT02748694|BG013|Baseline|Part 4: MRD: Placebo|TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia
11274017|NCT02748694|BG014|Baseline|Part 4: MRD: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
11274018|NCT02748694|BG015|Baseline|Total|Total of all reporting groups
11274019|NCT02748694|FG000|Participant Flow|Part 1 (SRD): Placebo Cohorts 1-5|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.
11274020|NCT02748694|FG001|Participant Flow|Part 1 (SRD): Cohort 1: TAK-041 5/20 mg|TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.
11274021|NCT02748694|FG002|Participant Flow|Part 1 (SRD): Cohort 2: TAK-041 10/40 mg|TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.
11274022|NCT02748694|FG003|Participant Flow|Part 1 (SRD): Cohort 3: TAK-041 80 mg|TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274023|NCT02748694|FG004|Participant Flow|Part 1 (SRD): Cohort 4: TAK-041 120 mg|TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274024|NCT02748694|FG005|Participant Flow|Part 1 (SRD): Cohort 5: TAK-041 160 mg|TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274025|NCT02748694|FG006|Participant Flow|Part 2 (MRD): Placebo Cohorts 1-4|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the multiple-rising dose (MRD) period.
11274026|NCT02748694|FG007|Participant Flow|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274027|NCT02748694|FG008|Participant Flow|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274028|NCT02748694|FG009|Participant Flow|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274029|NCT02748694|FG010|Participant Flow|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274030|NCT02748694|FG011|Participant Flow|Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A|TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.
11274031|NCT02748694|FG012|Participant Flow|Part 3: RBA/Food Effect: Regimen B|TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.
11274032|NCT02748694|FG013|Participant Flow|Part 4: MRD: Placebo|TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia
11274033|NCT02748694|FG014|Participant Flow|Part 4: MRD: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
11274034|NCT02748694|OG000|Outcome|Part 1 (SRD): Placebo Cohorts 1-5|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274035|NCT02748694|OG001|Outcome|Part 1 (SRD): Cohort 1: TAK-041 5 mg|TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274036|NCT02748694|OG002|Outcome|Part 1 (SRD): Cohort 2: TAK-041 10 mg|TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274037|NCT02748694|OG003|Outcome|Part 1 (SRD): Cohort 1: TAK-041 20 mg|TAK-041 20 mg, suspension, orally, once on Day 8 in the SRD period.
11274038|NCT02748694|OG004|Outcome|Part 1 (SRD): Cohort 2: TAK-041 40 mg|TAK-041 40 mg, suspension, orally, once on Day 8 in the SRD period.
11274039|NCT02748694|OG005|Outcome|Part 1 (SRD): Cohort 3: TAK-041 80 mg|TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274040|NCT02748694|OG006|Outcome|Part 1 (SRD): Cohort 4: TAK-041 120 mg|TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274041|NCT02748694|OG007|Outcome|Part 1 (SRD): Cohort 5: TAK-041 160 mg|TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274042|NCT02748694|OG008|Outcome|Part 2 (MRD): Placebo Cohorts 1-4|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.
11274043|NCT02748694|OG009|Outcome|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274044|NCT02748694|OG010|Outcome|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274045|NCT02748694|OG011|Outcome|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274046|NCT02748694|OG012|Outcome|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274047|NCT02748694|OG013|Outcome|Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A|TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.
11274048|NCT02748694|OG014|Outcome|Part 3: RBA/Food Effect: Regimen B|TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.
11274049|NCT02748694|OG015|Outcome|Part 4: MRD: Placebo|TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia
11274050|NCT02748694|OG016|Outcome|Part 4: MRD: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
11274051|NCT02748694|OG000|Outcome|Part 2 (MRD): Placebo Cohorts 1-4|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.
11274052|NCT02748694|OG001|Outcome|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274053|NCT02748694|OG002|Outcome|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274054|NCT02748694|OG003|Outcome|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274055|NCT02748694|OG004|Outcome|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274056|NCT02748694|OG000|Outcome|Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A|TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.
11274057|NCT02748694|OG001|Outcome|Part 3: RBA/Food Effect: Regimen B|TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.
11274058|NCT02748694|OG002|Outcome|Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1|Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.
11274059|NCT02748694|OG000|Outcome|Part 1 (SRD): Cohort 1: TAK-041 5 mg|TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274060|NCT02748694|OG001|Outcome|Part 1 (SRD): Cohort 2: TAK-041 10 mg|TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274061|NCT02748694|OG002|Outcome|Part 1 (SRD): Cohort 3: TAK-041 80 mg|TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274062|NCT02748694|OG003|Outcome|Part 1 (SRD): Cohort 4: TAK-041 120 mg|TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274063|NCT02748694|OG004|Outcome|Part 1 (SRD): Cohort 5: TAK-041 160 mg|TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274064|NCT02748694|OG000|Outcome|Part 1 (SRD): Cohort 1: TAK-041 20 mg|TAK-041 20 mg, suspension, orally, once on Day 8 in the SRD period.
11274065|NCT02748694|OG001|Outcome|Part 1 (SRD): Cohort 2: TAK-041 40 mg|TAK-041 40 mg, suspension, orally, once on Day 8 in the SRD period.
11274066|NCT02748694|OG000|Outcome|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274067|NCT02748694|OG001|Outcome|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274068|NCT02748694|OG002|Outcome|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274069|NCT02748694|OG003|Outcome|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274070|NCT02748694|OG004|Outcome|Part 4: MRD: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
11274071|NCT02748694|EG000|Reported Event|Part 1 (SRD): Placebo Cohorts 1-5|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274072|NCT02748694|EG001|Reported Event|Part 1 (SRD): Cohort 1: TAK-041 5 mg|TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274073|NCT02748694|EG002|Reported Event|Part 1 (SRD): Cohort 2: TAK-041 10 mg|TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274074|NCT02748694|EG003|Reported Event|Part 1 (SRD): Cohort 1: TAK-041 20 mg|TAK-041 20 mg, suspension, orally, once on Day 8 in the SRD period.
11274075|NCT02748694|EG004|Reported Event|Part 1 (SRD): Cohort 2: TAK-041 40 mg|TAK-041 40 mg, suspension, orally, once on Day 8 in the SRD period.
11274076|NCT02748694|EG005|Reported Event|Part 1 (SRD): Cohort 3: TAK-041 80 mg|TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274077|NCT02748694|EG006|Reported Event|Part 1 (SRD): Cohort 4: TAK-041 120 mg|TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274078|NCT02748694|EG007|Reported Event|Part 1 (SRD): Cohort 5: TAK-041 160 mg|TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.
11274079|NCT02748694|EG008|Reported Event|Part 2 (MRD): Placebo Cohorts 1-4|TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.
11274080|NCT02748694|EG009|Reported Event|Part 2 (MRD): Cohort 1: TAK-041 40/20 mg|TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274081|NCT02748694|EG010|Reported Event|Part 2 (MRD): Cohort 2: TAK-041 80/40 mg|TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274082|NCT02748694|EG011|Reported Event|Part 2 (MRD): Cohort 3: TAK-041 120/60 mg|TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274083|NCT02748694|EG012|Reported Event|Part 2 (MRD): Cohort 4: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.
11274084|NCT02748694|EG013|Reported Event|Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A|TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.
11274085|NCT02748694|EG014|Reported Event|Part 3: RBA/Food Effect: Regimen B|TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.
11274086|NCT02748694|EG015|Reported Event|Part 4: MRD: Placebo|TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia
11274087|NCT02748694|EG016|Reported Event|Part 4: MRD: TAK-041 160/80 mg|TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
11274088|NCT02748785|BG000|Baseline|Group 1|"Group 1 will continue MTX~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274089|NCT02748785|BG001|Baseline|Group 2|"Group 2 will hold MTX 4 weeks before vaccination and resume MTX on the day of vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274090|NCT02748785|BG002|Baseline|Group 3|"Group 3 will hold MTX 2 weeks before vaccination and resume MTX 2 weeks after vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274091|NCT02748785|BG003|Baseline|Group 4|"Group 4 will hold MTX on day of vaccination and resume MTX 4 weeks after vaccination.~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274092|NCT02748785|BG004|Baseline|Total|Total of all reporting groups
11274093|NCT02748785|FG000|Participant Flow|Group 1|"Group 1 will continue MTX~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274094|NCT02748785|FG001|Participant Flow|Group 2|"Group 2 will hold MTX 4 weeks before vaccination and resume MTX on the day of vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274095|NCT02748785|FG002|Participant Flow|Group 3|"Group 3 will hold MTX 2 weeks before vaccination and resume MTX 2 weeks after vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274096|NCT02748785|FG003|Participant Flow|Group 4|"Group 4 will hold MTX on day of vaccination and resume MTX 4 weeks after vaccination.~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274097|NCT02748785|OG000|Outcome|Group 1|"Group 1 will continue MTX~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274098|NCT02748785|OG001|Outcome|Group 2|"Group 2 will hold MTX 4 weeks before vaccination and resume MTX on the day of vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274099|NCT02748785|OG002|Outcome|Group 3|"Group 3 will hold MTX 2 weeks before vaccination and resume MTX 2 weeks after vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274100|NCT02748785|OG003|Outcome|Group 4|"Group 4 will hold MTX on day of vaccination and resume MTX 4 weeks after vaccination.~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274101|NCT02748785|EG000|Reported Event|Group 1|"Group 1 will continue MTX~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274102|NCT02748785|EG001|Reported Event|Group 2|"Group 2 will hold MTX 4 weeks before vaccination and resume MTX on the day of vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274103|NCT02748785|EG002|Reported Event|Group 3|"Group 3 will hold MTX 2 weeks before vaccination and resume MTX 2 weeks after vaccination~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274104|NCT02748785|EG003|Reported Event|Group 4|"Group 4 will hold MTX on day of vaccination and resume MTX 4 weeks after vaccination.~Methotrexate: Methotrexate will be continued~Seasonal Influenza vaccine: all subjects will be vaccinated with a seasonal influenza vaccine"
11274105|NCT02748863|BG000|Baseline|Secukinumab 2 mL PFS|Secukinumab 300 mg in one 2 mL pre-filled syringe
11274106|NCT02748863|BG001|Baseline|Secukinumab 2 x 1 mL PFS|Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
11274107|NCT02748863|BG002|Baseline|Placebo|Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
11274108|NCT02748863|BG003|Baseline|Total|Total of all reporting groups
11274109|NCT02748863|FG000|Participant Flow|Secukinumab 2 mL PFS|Secukinumab 300 mg in one 2 mL pre-filled syringe
11274110|NCT02748863|FG001|Participant Flow|Secukinumab 2 x 1 mL PFS|Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
11274111|NCT02748863|FG002|Participant Flow|Placebo|Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
11274112|NCT02748863|FG003|Participant Flow|Secukinumab 2 mL PFS Following Placebo|Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
11274113|NCT02748863|FG004|Participant Flow|Secukinumab 2 x 1 mL PFS Following Placebo|Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
11274114|NCT02748863|OG000|Outcome|Secukinumab 2 mL PFS|Secukinumab 300 mg in one 2 mL pre-filled syringe
11274115|NCT02748863|OG001|Outcome|Placebo|Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
11274116|NCT02748863|OG001|Outcome|Secukinumab 2 x 1 mL PFS|Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
11274117|NCT02748863|OG002|Outcome|Placebo|Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
11274118|NCT02748863|OG002|Outcome|Placebo|"Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe~From week 16 on is zero for all parameters in placebo group"
11274119|NCT02748863|OG003|Outcome|Secukinumab 2 mL PFS Following Placebo|Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
11274120|NCT02748863|OG004|Outcome|Secukinumab 2 x 1 mL PFS Following Placebo|Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
11274121|NCT02748863|EG000|Reported Event|Secukinumab 300 mg (2mL PFS)|Treatment period 1 secukinumab 300 mg (2mL pre-filled syringes)
11274122|NCT02748863|EG001|Reported Event|AIN457 300 mg (2x1mL PFS)|Treatment period 1 Secukinumab 300 mg in one 2 mL pre-filled syringe
11274123|NCT02748863|EG002|Reported Event|Placebo|Treatment period 1 Placebo
11274124|NCT02748863|EG003|Reported Event|Any AIN457 300 mg (2mL PFS)|Any AIN457 300 mg (2 mL pre-filled syringes)
11274125|NCT02748863|EG004|Reported Event|Any Secukuinumab 300 mg (2x1mL PFS)|Any AIN457 300 mg (2x1mL pre-filed syringes)
11274126|NCT02748863|EG005|Reported Event|Any Secukinumab 300 mg|Entire Any AIN457 300 mg
11274127|NCT02748889|BG000|Baseline|Carboplatin Plus Etoposide|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy"
11274128|NCT02748889|BG001|Baseline|Carboplatin, Etoposide and MPDL3280A|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy~MPDL3280A: Experimental biologic"
11274129|NCT02748889|BG002|Baseline|Total|Total of all reporting groups
11274130|NCT02748889|FG000|Participant Flow|Carboplatin Plus Etoposide|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy"
11274131|NCT02748889|FG001|Participant Flow|Carboplatin, Etoposide and MPDL3280A|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy~MPDL3280A: Experimental biologic"
11274132|NCT02748889|OG000|Outcome|Carboplatin, Etoposide and MPDL3280A|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy~MPDL3280A: Experimental biologic"
11274133|NCT02748889|EG000|Reported Event|Carboplatin, Etoposide and MPDL3280A|"Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression~Carboplatin: Standard chemotherapy~Etoposide: Standard chemotherapy~MPDL3280A: Experimental biologic"
11274134|NCT02748928|BG000|Baseline|Treated and Untreated Abdomen|Circumference and fat thickness measurements of abdomen before and after Ultrashape treatments of the same subjects
11274135|NCT02748928|FG000|Participant Flow|Treated and Untreated Abdomen|Circumference and fat thickness reduction of abdomen after Ultrashape treatments (three treatments with U-sculpt Power transducer Isppa 660 W/cm^2)
11274136|NCT02748928|OG000|Outcome|Treated Abdomen|Subjects treated on the abdomen with Ultrashape ultrasound treatments
11274137|NCT02748928|OG000|Outcome|Treated Abdomen|Abdomen treated with UltraShape ultrasound treatments
11274138|NCT02748928|EG000|Reported Event|Treated Abdomen|Subjects treated on the abdomen with Ultrashape ultrasound treatments
11274139|NCT02749201|BG000|Baseline|Analysis|"Light Intensity and gastric wall thickness analysis~Gastrisail: Light Intensity and gastric wall thickness assessment"
11274140|NCT02749201|FG000|Participant Flow|Analysis|"Light Intensity and gastric wall thickness analysis~Gastrisail: Light Intensity and gastric wall thickness assessment"
11274141|NCT02749201|OG000|Outcome|Analysis|"Light Intensity and gastric wall thickness analysis~Gastrisail: Light Intensity and gastric wall thickness assessment"
11274142|NCT02749201|EG000|Reported Event|Analysis|"Light Intensity and gastric wall thickness analysis~Gastrisail: Light Intensity and gastric wall thickness assessment"
11274143|NCT02749370|BG000|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
11274144|NCT02749370|FG000|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
11274145|NCT02749370|OG000|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
11274146|NCT02749370|EG000|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
11274147|NCT02749721|BG000|Baseline|Vortioxetine|vortioxetine 5-20 mg/day
11274148|NCT02749721|FG000|Participant Flow|Vortioxetine|vortioxetine 5-20 mg/day
11274149|NCT02749721|OG000|Outcome|Vortioxetine|vortioxetine 5-20 mg/day
11274150|NCT02749721|OG000|Outcome|Vortioxetine|"Open-label vortioxetine~vortioxetine: Open-label vortioxetine"
11274151|NCT02749721|OG000|Outcome|Vortioxetine|Open-label vortioxetine: 5-20 mg
11274152|NCT02749721|EG000|Reported Event|Vortioxetine|vortioxetine 5-20 mg/day
11274153|NCT02749799|BG000|Baseline|DFD-01 (Betamethasone Dipropionate) Spray, 0.05%|"DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.~DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days."
11274154|NCT02749799|FG000|Participant Flow|DFD-01 (Betamethasone Dipropionate) Spray, 0.05%|"DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.~DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days."
11274155|NCT02749799|OG000|Outcome|DFD-01 (Betamethasone Dipropionate) Spray, 0.05%|"DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.~DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days."
11274156|NCT02749799|EG000|Reported Event|DFD-01 (Betamethasone Dipropionate) Spray, 0.05%|"DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.~DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days."
11274157|NCT02749903|BG000|Baseline|Enzalutamide|Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
11274158|NCT02749903|FG000|Participant Flow|Enzalutamide|Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
11274159|NCT02749903|OG000|Outcome|Enzalutamide|Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
11274160|NCT02749903|EG000|Reported Event|Enzalutamide|Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
11274161|NCT02750267|BG000|Baseline|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
11274162|NCT02750267|BG001|Baseline|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
10847390|NCT00283062|BG002|Baseline|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
11274163|NCT02750267|BG002|Baseline|Total|Total of all reporting groups
11274164|NCT02750267|FG000|Participant Flow|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
11274165|NCT02750267|FG001|Participant Flow|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.~Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
11274166|NCT02750267|OG000|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
11274167|NCT02750267|OG001|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
11274168|NCT02750267|OG000|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
11274169|NCT02750267|OG001|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
11274170|NCT02750267|EG000|Reported Event|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
11274171|NCT02750267|EG001|Reported Event|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
11274172|NCT02750306|BG000|Baseline|Suvorexant|Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their Clinical Global Impression of Insomnia Severity (CGI-S) was ≥3 and investigators felt they could tolerate the increased dose.
11274173|NCT02750306|BG001|Baseline|Placebo|Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
11274174|NCT02750306|BG002|Baseline|Total|Total of all reporting groups
11274175|NCT02750306|FG000|Participant Flow|Suvorexant|Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their Clinical Global Impression of Insomnia Severity (CGI-S) was ≥3 and investigators felt they could tolerate the increased dose.
11274176|NCT02750306|FG001|Participant Flow|Placebo|Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
11274177|NCT02750306|OG000|Outcome|Suvorexant|Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
10970270|NCT00909779|FG001|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11274178|NCT02750306|OG001|Outcome|Placebo|Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
11274179|NCT02750306|EG000|Reported Event|Suvorexant|Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
11274180|NCT02750306|EG001|Reported Event|Placebo|Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
11274181|NCT02750332|BG000|Baseline|All Study Participants|
11274182|NCT02750332|FG000|Participant Flow|Treatment Sequence A (Fed) - B (Fasted)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
11274183|NCT02750332|FG001|Participant Flow|Treatment Sequence B (Fasted) - A (Fed)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
11274184|NCT02750332|OG000|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
11274185|NCT02750332|OG001|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
11274186|NCT02750332|EG000|Reported Event|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
11274187|NCT02750332|EG001|Reported Event|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
11274188|NCT02750345|BG000|Baseline|All Study Participants|Grouped by all participants as this is how overall data has been collected.
11274189|NCT02750345|FG000|Participant Flow|Sequence TP 1 - TP 2 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1 (TP 1)) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2 (TP 2)) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11286861|NCT02895035|OG000|Outcome|Epinephrine|"Epinephrine is the intracameral additive during cataract surgery.~Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery."
11274190|NCT02750345|FG001|Participant Flow|Sequence TP 1 - Reference - TP 2|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11274191|NCT02750345|FG002|Participant Flow|Sequence TP 2 - TP 1 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11274192|NCT02750345|FG003|Participant Flow|Sequence TP 2 - Reference - TP 1|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11274193|NCT02750345|FG004|Participant Flow|Sequence Reference - TP 1 - TP 2|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11274194|NCT02750345|FG005|Participant Flow|Sequence Reference - TP 2 - TP 1|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
11274195|NCT02750345|OG000|Outcome|Test Product 1|10 mg Nitisinone Tablet
11274196|NCT02750345|OG001|Outcome|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
11274197|NCT02750345|OG002|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
11274198|NCT02750345|OG000|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
11274199|NCT02750345|OG001|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
11274200|NCT02750345|EG000|Reported Event|Test Product 1|10 mg Nitisinone Tablet
11274201|NCT02750345|EG001|Reported Event|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
11274202|NCT02750345|EG002|Reported Event|Reference Product|ORFADIN®, 10 mg hard capsule
11274203|NCT02750410|BG000|Baseline|Placebo|Placebo administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
11274204|NCT02750410|BG001|Baseline|Dulaglutide|Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
11274205|NCT02750410|BG002|Baseline|Total|Total of all reporting groups
11274206|NCT02750410|FG000|Participant Flow|Placebo|Placebo administered subcutaneously (SC) once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 milligram (mg) administered SC once weekly for 36 weeks.
11274207|NCT02750410|FG001|Participant Flow|Dulaglutide|Dulaglutide administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
11274208|NCT02750410|OG000|Outcome|Placebo|Placebo administered SC for 16 weeks.
11274209|NCT02750410|OG001|Outcome|Dulaglutide|Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
11274210|NCT02750410|OG000|Outcome|Placebo|Placebo administered SC once weekly for 16 weeks.
11274211|NCT02750410|OG001|Outcome|Dulaglutide|Placebo administered SC once weekly for 16 weeks.
11274212|NCT02750410|EG000|Reported Event|Placebo Double-Blind (DB) Treatment Period|Placebo administered SC once weekly for 16 weeks.
11274213|NCT02750410|EG001|Reported Event|Dulaglutide 0.75 mg DB Treatment Period|Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
11274214|NCT02750410|EG002|Reported Event|Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period|Placebo administered SC once weekly for 16 weeks then Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
11274215|NCT02750410|EG003|Reported Event|Dulaglutide 0.75 mg DB Treatment/Extension Period|Dulaglutide 0.75 mg administered SC once weekly for 52 weeks.
11274216|NCT02750501|BG000|Baseline|Single Arm: Open Label|"RELiZORB cartridge and Impact Peptide 1.5 with enteral feeding 500 mL to 1,000 mL per enteral feeding for a period of 90 days.~RELiZORB: Novel enteral feeding in-line digestive enzyme cartridge~Impact Peptide 1.5: Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding"
11274217|NCT02750501|FG000|Participant Flow|Single Arm: Open Label|49 subjects signed consent and were screened for the study. 44 subjects were eligible at time of screening. 39 subjects entered the treatment period.
11274218|NCT02750501|OG000|Outcome|RELiZORB Cartridge With Standard Enteral Formula|Patients with exocrine pancreatic insufficiency, age 5 and older, all sexes who have an enteral feeding a minimum of 4 times per week.
11274219|NCT02750501|OG000|Outcome|RELiZORB Treatment Period (Day 0 - Day 90)|All subjects who entered the RELiZORB Treatment period and received at least one treatment with the study device. 39 subjects entered treatment period of EF with RELiZORB.
11274220|NCT02750501|OG000|Outcome|RELiZORB Treatment Period (Day 0 - Day 90)|All subjects who entered the treatment period and received at least one exposure to RELiZORB.
11274221|NCT02750501|OG000|Outcome|Safety Population|All subjects who entered the RELiZORB Treatment period and received at least one treatment with the study device. 39 subjects entered treatment period of EF with RELiZORB.
11274222|NCT02750501|EG000|Reported Event|Observation and Run-in Period (Day -14 to Day -1)|This 14 day period was comprised of 7 day Observation period followed by 7 day Run-in period. 44 subjects were enrolled of which 39 proceeded to treatment period of EF with RELiZORB.
11274223|NCT02750501|EG001|Reported Event|RELiZORB Treatment Period (Day 0 - Day 90)|Safety population is defined as all subjects who entered the RELiZORB Treatment period and received at least one treatment with the study device. 39 subjects entered treatment period of EF with RELiZORB.
11274224|NCT02750514|BG000|Baseline|Nivolumab|Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
11274225|NCT02750514|BG001|Baseline|Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274226|NCT02750514|BG002|Baseline|Nivolumab + BMS986016|Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
11274227|NCT02750514|BG003|Baseline|Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274228|NCT02750514|BG004|Baseline|Nivolumab + BMS986205|Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274229|NCT02750514|BG005|Baseline|Total|Total of all reporting groups
11274230|NCT02750514|FG000|Participant Flow|Nivolumab|Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
11274231|NCT02750514|FG001|Participant Flow|Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274232|NCT02750514|FG002|Participant Flow|Nivolumab + BMS986016|Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
11274233|NCT02750514|FG003|Participant Flow|Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274234|NCT02750514|FG004|Participant Flow|Nivolumab + BMS986205|Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274235|NCT02750514|OG000|Outcome|Nivolumab|Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
11274236|NCT02750514|OG001|Outcome|Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274237|NCT02750514|OG002|Outcome|Nivolumab + BMS986016|Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
11274238|NCT02750514|OG003|Outcome|Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274239|NCT02750514|OG004|Outcome|Nivolumab + BMS986205|Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274240|NCT02750514|EG000|Reported Event|Track 1 - Nivolumab|Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
11274241|NCT02750514|EG001|Reported Event|Track 1 - Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274242|NCT02750514|EG002|Reported Event|Track 1 - Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274243|NCT02750514|EG003|Reported Event|Track 2 - Nivolumab|Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
11274244|NCT02750514|EG004|Reported Event|Track 2 - Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274245|NCT02750514|EG005|Reported Event|Track 2 - Nivolumab + BMS986016|Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
11274246|NCT02750514|EG006|Reported Event|Track 2 - Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274247|NCT02750514|EG007|Reported Event|Track 3 - Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274248|NCT02750514|EG008|Reported Event|Track 3 - Nivolumab + BMS986016|Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
11274249|NCT02750514|EG009|Reported Event|Track 3 - Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274250|NCT02750514|EG010|Reported Event|Track 4 - Nivolumab + Dasatinib|Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274251|NCT02750514|EG011|Reported Event|Track 4 - Nivolumab + Ipilimumab|Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
11274252|NCT02750514|EG012|Reported Event|Track 5 - Nivolumab + BMS986205|Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
11274253|NCT02750592|BG000|Baseline|Secukinumab 150mg|A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
11286862|NCT02895035|OG001|Outcome|Omidria|"Omidria is the intracameral additive during cataract surgery.~Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery."
11274254|NCT02750592|FG000|Participant Flow|Secukinumab 150mg|A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
11274255|NCT02750592|OG000|Outcome|Secukinumab 150mg|A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
11274256|NCT02750592|EG000|Reported Event|AIN457 150mg|A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
11274257|NCT02750618|BG000|Baseline|Burosumab Q2W|Burosumab SC injections Q2W for a total of 160 weeks.
11274258|NCT02750618|FG000|Participant Flow|Burosumab Q2W|Burosumab subcutaneous (SC) injections every 2 weeks (Q2W) for a total of 160 weeks.
11274259|NCT02750618|OG000|Outcome|Burosumab Q2W|Burosumab SC injections Q2W for a total of 160 weeks.
11274260|NCT02750618|EG000|Reported Event|Burosumab Q2W|Burosumab SC injections Q2W for a total of 160 weeks.
11274261|NCT02750709|BG000|Baseline|All Study Participants|
11274262|NCT02750709|FG000|Participant Flow|Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274263|NCT02750709|FG001|Participant Flow|Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274264|NCT02750709|FG002|Participant Flow|Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274265|NCT02750709|FG003|Participant Flow|Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274266|NCT02750709|FG004|Participant Flow|Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274267|NCT02750709|FG005|Participant Flow|Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
11274268|NCT02750709|OG000|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
11274269|NCT02750709|OG001|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
11274270|NCT02750709|OG002|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
11274271|NCT02750709|EG000|Reported Event|Test Product 1|Nitisinone Tablet, 10 mg
11214753|NCT02294175|EG001|Reported Event|Sharp Debridement Therapy|"Bedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.~Bedside Sharp Debridement: The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound"
11214754|NCT02294227|BG000|Baseline|Secukinumab 150 mg|Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214755|NCT02294227|BG001|Baseline|Secukinumab 150 mg No Load|Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214756|NCT02294227|BG002|Baseline|Placebo|Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214757|NCT02294227|BG003|Baseline|Total|Total of all reporting groups
11214758|NCT02294227|FG000|Participant Flow|Secukinumab 150 mg|Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214759|NCT02294227|FG001|Participant Flow|Secukinumab 150 mg No Load|Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214760|NCT02294227|FG002|Participant Flow|Placebo|Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214761|NCT02294227|OG000|Outcome|Secukinumab 150 mg|Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214762|NCT02294227|OG001|Outcome|Secukinumab 150 mg No Load|Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214763|NCT02294227|OG002|Outcome|Placebo|Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214764|NCT02294227|OG002|Outcome|Placebo Non-responder|Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
11214765|NCT02294227|EG000|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
11214766|NCT02294227|EG001|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
11214767|NCT02294227|EG002|Reported Event|Any AIN457|Any AIN457
11214768|NCT02294227|EG003|Reported Event|Placebo|Placebo
11214769|NCT02294253|BG000|Baseline|Buprenorphine/Naloxone Stabilization|"Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,~Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone"
11214770|NCT02294253|FG000|Participant Flow|Buprenorphine/Naloxone Stabilization|"Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,~Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone"
11214771|NCT02294253|OG000|Outcome|Buprenorphine/Naloxone Stabilization|"Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,~Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone"
11214772|NCT02294253|EG000|Reported Event|Buprenorphine/Naloxone Stabilization|"Participants who have initially failed outpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,~Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone"
11214773|NCT02294318|BG000|Baseline|Motivational Interviewing (MI)|"Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm.~Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change."
11274272|NCT02750709|EG001|Reported Event|Test Product 2|Nitisinone Tablet (High Compritol), 10 mg
11274273|NCT02750709|EG002|Reported Event|Reference Product|ORFADIN® hard capsule, 10 mg
11274274|NCT02750761|BG000|Baseline|Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274275|NCT02750761|BG001|Baseline|Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274276|NCT02750761|BG002|Baseline|Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274277|NCT02750761|BG003|Baseline|Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274278|NCT02750761|BG004|Baseline|Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274279|NCT02750761|BG005|Baseline|Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274280|NCT02750761|BG006|Baseline|Total|Total of all reporting groups
11274281|NCT02750761|FG000|Participant Flow|Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274282|NCT02750761|FG001|Participant Flow|Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274283|NCT02750761|FG002|Participant Flow|Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274284|NCT02750761|FG003|Participant Flow|Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274285|NCT02750761|FG004|Participant Flow|Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274286|NCT02750761|FG005|Participant Flow|Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274287|NCT02750761|OG000|Outcome|Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274288|NCT02750761|OG001|Outcome|Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274289|NCT02750761|OG002|Outcome|Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274290|NCT02750761|OG003|Outcome|Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274291|NCT02750761|OG004|Outcome|Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274292|NCT02750761|OG005|Outcome|Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274293|NCT02750761|OG000|Outcome|Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274294|NCT02750761|OG001|Outcome|Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274295|NCT02750761|OG000|Outcome|IV Group|Combined group of participants from Groups 1-2. Participants 2 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3, 4, 5, or 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274296|NCT02750761|OG001|Outcome|Oral Group|Combined group of participants from Groups 3-4. Participants 2 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 or 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274297|NCT02750761|EG000|Reported Event|Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274298|NCT02750761|EG001|Reported Event|Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
10970271|NCT00909779|OG000|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11274299|NCT02750761|EG002|Reported Event|Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274300|NCT02750761|EG003|Reported Event|Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)|Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274301|NCT02750761|EG004|Reported Event|Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)|Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274302|NCT02750761|EG005|Reported Event|Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years)|Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
11274303|NCT02750800|BG000|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11274304|NCT02750800|BG001|Baseline|Crohn's Disease|Participants with Crohn's disease
11274305|NCT02750800|BG002|Baseline|Psoriasis|Participants with psoriasis
11274306|NCT02750800|BG003|Baseline|Psoriatic Arthritis|Participants with psoriatic arthritis
11274307|NCT02750800|BG004|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis
11274308|NCT02750800|BG005|Baseline|Ulcerative Colitis|Participants with ulcerative colitis
11274309|NCT02750800|BG006|Baseline|Total|Total of all reporting groups
11274310|NCT02750800|FG000|Participant Flow|Adalimumab and AbbVie Care 2.0|Adalimumab administered via subcutaneous (SC) injection for 12 months according to the approved EMA label and Hungarian financial protocols and supportive services via the AbbVie Care 2.0 patient support program
11274311|NCT02750800|OG000|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
11274312|NCT02750800|OG001|Outcome|Crohn's Disease|Participants with Crohn's disease
11274313|NCT02750800|OG002|Outcome|Psoriasis|Participants with psoriasis
11274314|NCT02750800|OG003|Outcome|Psoriatic Arthritis|Participants with psoriatic arthritis
11274315|NCT02750800|OG004|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis
11274316|NCT02750800|OG005|Outcome|Ulcerative Colitis|Participants with ulcerative colitis
10970272|NCT00909779|OG001|Outcome|Placebo|Placebo twice daily
11274317|NCT02750800|OG000|Outcome|Crohn's Disease|Participants with Crohn's disease
11274318|NCT02750800|OG001|Outcome|Ulcerative Colitis|Participants with ulcerative colitis
11274319|NCT02750800|OG000|Outcome|Psoriasis|Participants with psoriasis
11274320|NCT02750800|OG001|Outcome|Psoriatic Arthritis|Participants with psoriatic arthritis
11274321|NCT02750800|OG001|Outcome|Psoriatic Arthritis With Axial Symptoms|Participants with psoriatic arthritis with axial symptoms
11274322|NCT02750800|OG000|Outcome|Psoriatic Arthritis With Peripheral Symptoms|Participants with psoriatic arthritis and peripheral symptoms
11274323|NCT02750800|OG001|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis
11274324|NCT02750800|OG000|Outcome|Ulcerative Colitis|Participants with ulcerative colitis
11274325|NCT02750800|OG004|Outcome|Ulcerative Colitis|Participants with ulcerative colitis
11274326|NCT02750800|EG000|Reported Event|Adalimumab and AbbVie Care 2.0|Adalimumab administered via subcutaneous (SC) injection for 12 months according to the approved EMA label and Hungarian financial protocols and supportive services via the AbbVie Care 2.0 patient support program
11274327|NCT02750813|BG000|Baseline|Overall|Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11274328|NCT02750813|FG000|Participant Flow|DT1, Then AO1D|Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
11274329|NCT02750813|FG001|Participant Flow|AO1D, Then DT1|Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
11274330|NCT02750813|OG000|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
11274331|NCT02750813|OG001|Outcome|AO1D|Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
11274332|NCT02750813|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11274333|NCT02750813|EG001|Reported Event|DAILIES TOTAL1 (DT1)|All subjects exposed to DT1 contact lenses, except for lenses used for parameter optimization and fitting
11274334|NCT02750813|EG002|Reported Event|ACUVUE OASYS 1-DAY (AO1D)|All subjects exposed to AO1D contact lenses, except for lenses used for parameter optimization and fitting
11274335|NCT02750930|BG000|Baseline|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
11274336|NCT02750930|FG000|Participant Flow|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 milligram (mg) at a volume of 1 millilitre (mL) as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
11274337|NCT02750930|OG000|Outcome|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
11274338|NCT02750930|EG000|Reported Event|Albiglutide Liquid|The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
11274339|NCT02750943|BG000|Baseline|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274340|NCT02750943|BG001|Baseline|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274341|NCT02750943|BG002|Baseline|Total|Total of all reporting groups
11274342|NCT02750943|FG000|Participant Flow|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274343|NCT02750943|FG001|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274344|NCT02750943|OG000|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274345|NCT02750943|OG001|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274346|NCT02750943|EG000|Reported Event|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274347|NCT02750943|EG001|Reported Event|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
11274348|NCT02751320|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
11274349|NCT02751320|FG000|Participant Flow|Overall Study|This was a single-centre, randomized, blinded (examiner and laboratory analyst), placebo-controlled, 6-treatment, 4-period cross-over, incomplete block design, in situ caries study in healthy adults who wore a removable bilateral mandibular partial denture. Each participant received Test Product 1 (Dentifrice containing 0.425 % weight by weight (w/w) phytate, and 1150 parts per million [ppm] fluoride [F]), Test Product 2 (Dentifrice containing 0.85 % w/w phytate, and 1150 ppm fluoride), Test Product 3 (Dentifrice containing 0.85 % w/w phytate, 0.3% zinc chloride, 0.5% sodium citrate, and 1150 ppm fluoride), Reference Product 1 (0 ppm fluoride), Reference Product 2 (Dentrifrice containing 1150 ppm fluoride toothpaste and Reference Product 3 (Dentrifrice containing 0.3% zinc chloride , 0.5% sodium citrate, and 1150 ppm fluoride).
11274350|NCT02751320|OG000|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15 milliliters (ml) of tap water for approximately 10 seconds (s).
11274351|NCT02751320|OG001|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274352|NCT02751320|OG002|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274353|NCT02751320|OG003|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274354|NCT02751320|OG000|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274355|NCT02751320|OG001|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s
11274356|NCT02751320|OG002|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274357|NCT02751320|OG003|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274358|NCT02751320|OG000|Outcome|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274359|NCT02751320|OG001|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274360|NCT02751320|OG003|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274361|NCT02751320|OG000|Outcome|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274362|NCT02751320|OG001|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274363|NCT02751320|OG002|Outcome|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274364|NCT02751320|OG003|Outcome|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274365|NCT02751320|OG004|Outcome|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274366|NCT02751320|OG005|Outcome|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274367|NCT02751320|EG000|Reported Event|Test Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274368|NCT02751320|EG001|Reported Event|Test Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274369|NCT02751320|EG002|Reported Event|Test Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s
11274370|NCT02751320|EG003|Reported Event|Reference Product 1|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274371|NCT02751320|EG004|Reported Event|Reference Product 2|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274372|NCT02751320|EG005|Reported Event|Reference Product 3|Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s.
11274373|NCT02751359|BG000|Baseline|Single Group - Repeated Measures|Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).
11274374|NCT02751359|FG000|Participant Flow|Single Group - Repeated Measures|Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study day; on 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg).
11274375|NCT02751359|OG000|Outcome|Active CBD 200 mg|Cannabidiol: 200mg
11274376|NCT02751359|OG001|Outcome|Active CBD 400 mg|Cannabidiol: 400mg
11274377|NCT02751359|OG002|Outcome|Active CBD 800 mg|Cannabidiol: 800mg
11274378|NCT02751359|OG003|Outcome|Placebo|"On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)~Placebo: 0 mg Cannabidiol"
11274379|NCT02751359|EG000|Reported Event|Active CBD 200 mg|Cannabidiol: 200mg
11274380|NCT02751359|EG001|Reported Event|Active CBD 400 mg|Cannabidiol: 400mg
11274381|NCT02751359|EG002|Reported Event|Active CBD 800 mg|Cannabidiol: 800mg
11274382|NCT02751359|EG003|Reported Event|Placebo|"On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)~Placebo: 0 mg Cannabidiol"
11286863|NCT02895035|EG000|Reported Event|Epinephrine|"Epinephrine is the intracameral additive during cataract surgery.~Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery."
11274383|NCT02751385|BG000|Baseline|All Patients|"Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.~Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.~Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®. Same subjects were continued to Period 2, hence baseline characteristics are presented by Period 1."
11274384|NCT02751385|FG000|Participant Flow|Microgynon®|Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.
11274385|NCT02751385|FG001|Participant Flow|Microgynon® With Nintedanib|"Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.~Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®."
11274386|NCT02751385|OG000|Outcome|Microgynon®|Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.
11274387|NCT02751385|OG001|Outcome|Microgynon® With Nintedanib|"Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.~Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®."
11274388|NCT02751385|EG000|Reported Event|Microgynon®|Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.
11274389|NCT02751385|EG001|Reported Event|Loading Nintedanib|Patients on nintedanib loading phase
11274390|NCT02751385|EG002|Reported Event|Nintedanib+Microgynon®|Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg if required) for at least 7 consecutive days in Period 2. Nintedanib was to be taken continuously throughout in Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they have taken nintedanib for at least 7 consecutive days before intake of Microgynon®.
11274391|NCT02751385|EG003|Reported Event|Nintedanib|Patients administered with nintedanib
11274392|NCT02751424|BG000|Baseline|GSK3342830 250 mg|Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.
11274393|NCT02751424|BG001|Baseline|GSK3342830 500 mg|Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.
11274394|NCT02751424|BG002|Baseline|GSK3342830 1000 mg|The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.
11274395|NCT02751424|BG003|Baseline|GSK3342830 2000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.
11274396|NCT02751424|BG004|Baseline|GSK3342830 4000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.
11274397|NCT02751424|BG005|Baseline|GSK3342830 6000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.
11274398|NCT02751424|BG006|Baseline|Placebo, Part 1|Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
11274399|NCT02751424|BG007|Baseline|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274400|NCT02751424|BG008|Baseline|Placebo, Part 2|Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274401|NCT02751424|BG009|Baseline|Total|Total of all reporting groups
11274402|NCT02751424|FG000|Participant Flow|GSK3342830 250 mg|Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 milligram (mg),for 1 hour (hr) as a single intravenous (IV) infusion, on Day 1.
11274403|NCT02751424|FG001|Participant Flow|GSK3342830 500 mg|Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.
11274404|NCT02751424|FG002|Participant Flow|GSK3342830 1000 mg|The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.
11274405|NCT02751424|FG003|Participant Flow|GSK3342830 2000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.
11274406|NCT02751424|FG004|Participant Flow|GSK3342830 4000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.
11274407|NCT02751424|FG005|Participant Flow|GSK3342830 6000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.
11274408|NCT02751424|FG006|Participant Flow|Placebo, Part 1|Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
11214774|NCT02294318|BG001|Baseline|HealthCall+Motivational Interviewing|"The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use.~HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session."
11214775|NCT02294318|BG002|Baseline|Total|Total of all reporting groups
11214776|NCT02294318|FG000|Participant Flow|Motivational Interviewing (MI)|"Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm.~Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change."
11214777|NCT02294318|FG001|Participant Flow|HealthCall+Motivational Interviewing|"The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use.~HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session."
11214778|NCT02294318|OG000|Outcome|Motivational Interviewing (MI)|"Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm.~Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change."
11214779|NCT02294318|OG001|Outcome|HealthCall+Motivational Interviewing|"The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use.~HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session."
11214780|NCT02294318|EG000|Reported Event|Motivational Interviewing (MI)|"Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm.~Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change."
11214781|NCT02294318|EG001|Reported Event|HealthCall+Motivational Interviewing|"The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use.~HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session."
11214782|NCT02294396|BG000|Baseline|Mirabegron + Solifenacin|Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective.
11274409|NCT02751424|FG007|Participant Flow|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, three times a day (TID) IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274410|NCT02751424|FG008|Participant Flow|Placebo, Part 2|Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274411|NCT02751424|OG000|Outcome|GSK3342830 250 mg|Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg, for 1 hr as a single IV infusion, on Day 1.
11274412|NCT02751424|OG001|Outcome|GSK3342830 500 mg|Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.
11274413|NCT02751424|OG002|Outcome|GSK3342830 1000 mg|The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.
11274414|NCT02751424|OG003|Outcome|GSK3342830 2000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.
11274415|NCT02751424|OG004|Outcome|GSK3342830 4000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.
11274416|NCT02751424|OG005|Outcome|GSK3342830 6000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.
11274417|NCT02751424|OG006|Outcome|Placebo, Part 1|Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
11274418|NCT02751424|OG000|Outcome|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID, IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274419|NCT02751424|OG001|Outcome|Placebo, Part 2|Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274420|NCT02751424|OG000|Outcome|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274421|NCT02751424|OG000|Outcome|GSK3342830 250 mg to 6000 mg|The data for healthy adult participants in all the cohorts starting from GSK3342830, cohort 250 to 6000 mg, were assessed. The participants had received escalated doses from 250 mg, 500 mg, 1000 mg, 2000 mg, 4000 mg, and 6000 mg. Each dose was administered as a single intravenous infusion for 1 hr on Day 1.
11274422|NCT02751424|OG000|Outcome|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID, IV infusions (approximately every 8 hours) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274423|NCT02751424|EG000|Reported Event|GSK3342830 250 mg|Healthy adult participants in this cohort, were administered GSK3342830 dose in Part 1 as 250 mg,for 1 hr, as a single IV infusion, on Day 1.
11274424|NCT02751424|EG001|Reported Event|GSK3342830 500 mg|Healthy adult participants in this cohort received an escalated dose GSK3342830 at 500 mg, for 1 hr, as a single IV infusion on Day 1.
11274425|NCT02751424|EG002|Reported Event|GSK3342830 1000 mg|The healthy adult participants in this cohort received an escalated dose GSK3342830 at 1000 mg, for 1 hr, as a single IV infusion on Day 1.
11274426|NCT02751424|EG003|Reported Event|GSK3342830 2000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 2000 mg, for 1 hr, as a single IV infusion on Day 1.
11274427|NCT02751424|EG004|Reported Event|GSK3342830 4000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 4000 mg, for 1 hr, as a single IV infusion on Day 1.
11274428|NCT02751424|EG005|Reported Event|GSK3342830 6000 mg|The healthy adult participants in this cohort received an escalated dose of GSK3342830 at 6000 mg, for 1 hr, as a single IV infusion on Day 1.
11274429|NCT02751424|EG006|Reported Event|Placebo, Part 1|Healthy adult participants from each cohort received placebo in form of infusion for 1 hr, on Day 1.
11274430|NCT02751424|EG007|Reported Event|GSK3342830 1000 mg TID|Healthy adult participants in this repeat dose escalation cohort were administered GSK3342830 dose, in Part 2 as 1000 mg, as a single IV infusion on Day 1, TID, IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274431|NCT02751424|EG008|Reported Event|Placebo, Part 2|Healthy adult participants in this repeat dose escalation cohort were administered with matching placebo to GSK3342830 1000 mg TID, Single IV infusion on Day 1, TID IV infusions (approximately every 8 hrs) on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and a single IV infusion on Day 15.
11274432|NCT02751450|BG000|Baseline|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274433|NCT02751450|BG001|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274434|NCT02751450|BG002|Baseline|Total|Total of all reporting groups
11274435|NCT02751450|FG000|Participant Flow|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274436|NCT02751450|FG001|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274437|NCT02751450|OG000|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274438|NCT02751450|OG001|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274439|NCT02751450|OG000|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274440|NCT02751450|OG001|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274441|NCT02751450|EG000|Reported Event|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274442|NCT02751450|EG001|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
11274443|NCT02751580|BG000|Baseline|Health Services Research (Telehealth)|"Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device.~Telemedicine: Attend a virtual visit via the JeffConnect telehealth app~Questionnaire Administration: Ancillary studies"
11274444|NCT02751580|FG000|Participant Flow|Health Services Research (Telehealth)|"Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device.~Telemedicine: Attend a virtual visit via the JeffConnect telehealth app~Questionnaire Administration: Ancillary studies"
11274445|NCT02751580|OG000|Outcome|Health Services Research (Telehealth)|"Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device.~Telemedicine: Attend a virtual visit via the JeffConnect telehealth app~Questionnaire Administration: Ancillary studies"
11274446|NCT02751580|EG000|Reported Event|Health Services Research (Telehealth)|"Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device.~Telemedicine: Attend a virtual visit via the JeffConnect telehealth app~Questionnaire Administration: Ancillary studies"
11274447|NCT02751827|BG000|Baseline|Prospective Cohort|"Prospective cohort involving patients treated in four distinct centers.~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274448|NCT02751827|BG001|Baseline|Retrospective Cohort A|"Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274449|NCT02751827|BG002|Baseline|Retrospective Cohort B|"Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274450|NCT02751827|BG003|Baseline|Total|Total of all reporting groups
11274451|NCT02751827|FG000|Participant Flow|Prospective Cohort|Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
11274452|NCT02751827|FG001|Participant Flow|Retrospective Cohort A|Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
11274453|NCT02751827|FG002|Participant Flow|Retrospective Cohort B|Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
11274454|NCT02751827|OG000|Outcome|Prospective Cohort|"Prospective cohort involving patients treated in four distinct centers.~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274455|NCT02751827|OG001|Outcome|Retrospective Cohort A|"Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274456|NCT02751827|OG002|Outcome|Retrospective Cohort B|"Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274457|NCT02751827|EG000|Reported Event|Prospective Cohort|"Prospective cohort involving patients treated in four distinct centers.~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274458|NCT02751827|EG001|Reported Event|Retrospective Cohort A|"Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274459|NCT02751827|EG002|Reported Event|Retrospective Cohort B|"Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France).~Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA)."
11274460|NCT02751879|BG000|Baseline|Gi(l)Otrif ≥ 40 mg|Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
11274461|NCT02751879|BG001|Baseline|Gi(l)Otrif ≤ 30 mg|Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
11274462|NCT02751879|BG002|Baseline|Total|Total of all reporting groups
11274463|NCT02751879|FG000|Participant Flow|Gi(l)Otrif ≥ 40 mg|Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
11274464|NCT02751879|FG001|Participant Flow|Gi(l)Otrif ≤ 30 mg|Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
11274465|NCT02751879|OG000|Outcome|Gi(l)Otrif ≥ 40 mg|Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
11274466|NCT02751879|OG001|Outcome|Gi(l)Otrif ≤ 30 mg|Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
11274467|NCT02751879|OG000|Outcome|Modified Starting Dose of Gi(l)Otrif|All patients who were treated with starting dose other than recommended dose of 40 mg Gi(l)otrif treatment once daily.
11274468|NCT02751879|OG000|Outcome|Modified Dose of 50 mg Gi(l)Otrif|All patients who were treated with modified dose of 50 mg Gi(l)otrif treatment once daily.
11274469|NCT02751879|OG001|Outcome|Modified Dose of ≤ 30 mg Gi(l)Otrif|All patients who were treated with modified starting dose of less than of equal to 30 mg Gi(l)otrif treatment once daily.
11274470|NCT02751879|EG000|Reported Event|Gi(l)Otrif ≥ 40 mg|Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
11274471|NCT02751879|EG001|Reported Event|Gi(l)Otrif ≤ 30 mg|Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
10847391|NCT00283062|BG003|Baseline|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
11274472|NCT02751931|BG000|Baseline|Children (3 to < 12 Years)|Participants aged 3 to < 12 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274473|NCT02751931|BG001|Baseline|Adolescents (12 to < 18 Years)|Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274474|NCT02751931|BG002|Baseline|Total|Total of all reporting groups
11274475|NCT02751931|FG000|Participant Flow|Children (3 to < 12 Years)|Participants aged 3 to < 12 years received initial dose of 25 milligram (mg) of mirabegron orally once daily based on weight (pediatric equivalent dose of 25 mg (milligram) [PED25]) on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 end-of-study (EOS) or end-of-treatment (EOT).
11274476|NCT02751931|FG001|Participant Flow|Adolescents (12 to < 18 Years)|Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274477|NCT02751931|OG000|Outcome|Children (3 to < 12 Years)|Participants aged 3 to < 12 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults (PED50) based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274478|NCT02751931|OG001|Outcome|Adolescents (12 to < 18 Years)|Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults (PED50) based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274479|NCT02751931|OG000|Outcome|Children (3 to < 12 Years)|Participants aged 3 to < 12 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274480|NCT02751931|OG001|Outcome|Adolescents (12 to < 18 Years)|Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274481|NCT02751931|OG000|Outcome|Children PED25 (PKAS)|Participants aged 3 to < 12 years who received pediatric equivalent dose of 25 mg at the time of PK sampling.
11274482|NCT02751931|OG001|Outcome|Adolescents PED25 (PKAS)|Participants aged 12 to < 18 years who received pediatric equivalent dose of 25 mg at the time of PK sampling.
11274483|NCT02751931|OG002|Outcome|Children PED50 (PKAS)|Participants aged 3 to < 12 years who received pediatric equivalent dose of 50 mg at the time of PK sampling.
11274484|NCT02751931|OG003|Outcome|Adolescents PED50 (PKAS)|Participants aged 12 to < 18 years who received pediatric equivalent dose of 50 mg at the time of PK sampling.
11274485|NCT02751931|EG000|Reported Event|Children (3 to < 12 Years)|Participants aged 3 to < 12 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274486|NCT02751931|EG001|Reported Event|Adolescents (12 to < 18 Years)|Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight [PED25] on day 1. At weeks 2, 4 or 8, participant's were up-titrated to the pediatric equivalent dose of 50 mg in adults [PED50] based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT.
11274487|NCT02751983|BG000|Baseline|Treatment as Usual Plus ACT|"Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.~ACT for Life: A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge."
11274488|NCT02751983|BG001|Baseline|Treatment as Usual|"Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management."
11274489|NCT02751983|BG002|Baseline|Total|Total of all reporting groups
11274490|NCT02751983|FG000|Participant Flow|Treatment as Usual Plus ACT|"Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.~ACT for Life: A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge."
11274491|NCT02751983|FG001|Participant Flow|Treatment as Usual|"Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management."
11286864|NCT02895035|EG001|Reported Event|Omidria|"Omidria is the intracameral additive during cataract surgery.~Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery."
11286865|NCT02895100|BG000|Baseline|PTG-100 (150 mg QD)|"Low dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286866|NCT02895100|BG001|Baseline|PTG-100 (300 mg QD)|"Medium dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274492|NCT02751983|OG000|Outcome|Treatment as Usual Plus ACT|"Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.~ACT for Life: A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge."
11274493|NCT02751983|OG001|Outcome|Treatment as Usual|"Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management."
11274494|NCT02751983|EG000|Reported Event|Treatment as Usual Plus ACT|"Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.~ACT for Life: A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge."
11274495|NCT02751983|EG001|Reported Event|Treatment as Usual|"Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care).~Treatment as usual: All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management."
11274496|NCT02752048|BG000|Baseline|TAS-205（Low Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274497|NCT02752048|BG001|Baseline|TAS-205（High Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274498|NCT02752048|BG002|Baseline|Placebo|Placebo: 1 group: Placebo group. Oral administration for 24 weeks, BID after meal
11274499|NCT02752048|BG003|Baseline|Total|Total of all reporting groups
11274500|NCT02752048|FG000|Participant Flow|TAS-205（Low Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274501|NCT02752048|FG001|Participant Flow|TAS-205（High Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274502|NCT02752048|FG002|Participant Flow|Placebo|Placebo: 1 group: Placebo group. Oral administration for 24 weeks, BID after meal
11274503|NCT02752048|OG000|Outcome|TAS-205（Low Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274504|NCT02752048|OG001|Outcome|TAS-205（High Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274505|NCT02752048|OG002|Outcome|Placebo|Placebo: 1 group: Placebo group. Oral administration for 24 weeks, BID after meal
11274506|NCT02752048|EG000|Reported Event|TAS-205（Low Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274507|NCT02752048|EG001|Reported Event|TAS-205（High Dose Group）|TAS-205: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
11274508|NCT02752048|EG002|Reported Event|Placebo|Placebo: 1 group: Placebo group. Oral administration for 24 weeks, BID after meal
11274509|NCT02752074|BG000|Baseline|Pembrolizumab + Epacadostat|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Epacadostat will be administered orally daily starting at Day 1 (Week 1).
11274510|NCT02752074|BG001|Baseline|Pembrolizumab + Placebo|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Placebo will be administered orally daily starting at Day 1 (Week 1).
11274511|NCT02752074|BG002|Baseline|Total|Total of all reporting groups
11274512|NCT02752074|FG000|Participant Flow|Pembrolizumab + Epacadostat|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Epacadostat will be administered orally daily starting at Day 1 (Week 1).
11274513|NCT02752074|FG001|Participant Flow|Pembrolizumab + Placebo|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Placebo will be administered orally daily starting at Day 1 (Week 1).
11274514|NCT02752074|OG000|Outcome|Pembrolizumab + Epacadostat|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Epacadostat will be administered orally daily starting at Day 1 (Week 1).
11274515|NCT02752074|OG001|Outcome|Pembrolizumab + Placebo|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Placebo will be administered orally daily starting at Day 1 (Week 1).
11274516|NCT02752074|EG000|Reported Event|Pembrolizumab + Epacadostat|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Epacadostat will be administered orally daily starting at Day 1 (Week 1).
11274517|NCT02752074|EG001|Reported Event|Pembrolizumab + Placebo|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1). Placebo will be administered orally daily starting at Day 1 (Week 1).
11274518|NCT02752087|BG000|Baseline|All Participants|U-193 LY900014 test formulation administered once SC in 2 of 4 study periods. U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
11274519|NCT02752087|FG000|Participant Flow|LY900014 Test/Reference/Test/Reference|U-193 LY900014 test formulation administered once subcutaneously (SC) in Study Periods 1 and 3. U-95 LY900014 reference formulation administered once SC in Study Periods 2 and 4.
11274520|NCT02752087|FG001|Participant Flow|LY900014 Reference/Test/Reference/Test|U-95 LY900014 reference formulation administered once SC in study periods 1 and 3. U-193 LY900014 test formulation administered once SC in study periods 2 and 4.
11274521|NCT02752087|OG000|Outcome|LY900014 Reference|U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
11274522|NCT02752087|OG001|Outcome|LY900014 Test|U-193 LY900014 test formulation administered once SC in 2 of 4 study periods.
11274523|NCT02752087|EG000|Reported Event|LY900014 Test|U-193 LY900014 test formulation administered once SC in 2 of 4 study periods.
11274524|NCT02752087|EG001|Reported Event|LY900014 Reference|U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
11274525|NCT02752256|BG000|Baseline|Intervention/Transfer|"Patients who are transferred via air ambulance to a comprehensive stroke center~Tissue Plasminogen Activator"
11274526|NCT02752256|BG001|Baseline|Control|"Patients presenting directly to the comprehensive stroke center~Tissue Plasminogen Activator"
11274527|NCT02752256|BG002|Baseline|Total|Total of all reporting groups
11274528|NCT02752256|FG000|Participant Flow|Intervention/Transfer|"Patients who are transferred via air ambulance to a comprehensive stroke center~Tissue Plasminogen Activator"
11274529|NCT02752256|FG001|Participant Flow|Control|"Patients presenting directly to the comprehensive stroke center~Tissue Plasminogen Activator"
11274530|NCT02752256|OG000|Outcome|Intervention/Transfer|"Patients who are transferred via air ambulance to a comprehensive stroke center~Tissue Plasminogen Activator"
11274531|NCT02752256|OG001|Outcome|Control|"Patients presenting directly to the comprehensive stroke center~Tissue Plasminogen Activator"
10847392|NCT00283062|BG004|Baseline|Total|Total of all reporting groups
10970273|NCT00909779|OG000|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
11274532|NCT02752256|EG000|Reported Event|Intervention/Transfer|"Patients who are transferred via air ambulance to a comprehensive stroke center~Tissue Plasminogen Activator"
11274533|NCT02752256|EG001|Reported Event|Control|"Patients presenting directly to the comprehensive stroke center~Tissue Plasminogen Activator"
11274534|NCT02752490|BG000|Baseline|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
11274535|NCT02752490|BG001|Baseline|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
11274536|NCT02752490|BG002|Baseline|Total|Total of all reporting groups
11274537|NCT02752490|FG000|Participant Flow|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
11274538|NCT02752490|FG001|Participant Flow|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
11274539|NCT02752490|OG000|Outcome|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
11274540|NCT02752490|OG001|Outcome|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
11274541|NCT02752490|EG000|Reported Event|Liberal Use of Maternal Oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
11274542|NCT02752490|EG001|Reported Event|Indicated Use of Maternal Oxygen|Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
11274543|NCT02752633|BG000|Baseline|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
11274544|NCT02752633|FG000|Participant Flow|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
11286867|NCT02895100|BG002|Baseline|PTG-100 (900 mg QD)|"High dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286868|NCT02895100|BG003|Baseline|Placebo Group|"Placebo control~Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period."
11274545|NCT02752633|OG000|Outcome|Allopurinol/Febuxostat Treatment|"Following a 7 day washout period all patients receive allopurinol (400 mg/day) as a single daily dose for 2 weeks. Following another 7 day washout period all participants receive febuxostat, 80 mg/day as a single daily dose, for 2 weeks.~Allopurinol: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.~Febuxostat: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency."
11274546|NCT02752633|EG000|Reported Event|Allopurinol/Febuxostat Treatment|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
11274547|NCT02752776|BG000|Baseline|Subpopulation A (Naive)|Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.
11274548|NCT02752776|BG001|Baseline|Subpopulation B (Non-biologic)|Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.
11274549|NCT02752776|BG002|Baseline|Subpopulation C (Biologic)|Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
11274550|NCT02752776|BG003|Baseline|Total|Total of all reporting groups
11274551|NCT02752776|FG000|Participant Flow|Subpopulation A (Naive)|Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.
11274552|NCT02752776|FG001|Participant Flow|Subpopulation B (Non-biologic)|Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.
11274553|NCT02752776|FG002|Participant Flow|Subpopulation C (Biologic)|Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
11274554|NCT02752776|OG000|Outcome|Subpopulation A (Naive)|Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.
11274555|NCT02752776|OG001|Outcome|Subpopulation B (Non-biologic)|Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.
11274556|NCT02752776|OG002|Outcome|Subpopulation C (Biologic)|Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
11274557|NCT02752776|OG003|Outcome|All Participants|Participants from all 3 subpopulations: Subpopulation A B & C combined
11274558|NCT02752776|EG000|Reported Event|Subpopulation A (Naive)|Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.
11274559|NCT02752776|EG001|Reported Event|Subpopulation B (Non-biologic)|Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.
11274560|NCT02752776|EG002|Reported Event|Subpopulation C (Biologic)|Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
11274561|NCT02752776|EG003|Reported Event|All Participants|Participants from all 3 subpopulations: Subpopulation A B & C combined
11274562|NCT02752802|BG000|Baseline|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274563|NCT02752802|BG001|Baseline|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274564|NCT02752802|BG002|Baseline|Total|Total of all reporting groups
11274565|NCT02752802|FG000|Participant Flow|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274566|NCT02752802|FG001|Participant Flow|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274567|NCT02752802|OG000|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274568|NCT02752802|OG001|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274569|NCT02752802|OG000|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11286869|NCT02895100|BG004|Baseline|Total|Total of all reporting groups
11274570|NCT02752802|OG001|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274571|NCT02752802|EG000|Reported Event|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274572|NCT02752802|EG001|Reported Event|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
11274573|NCT02752880|BG000|Baseline|YH1 Group|YH1 three times per day for 12 consecutive weeks.
11274574|NCT02752880|BG001|Baseline|Placebo Group|placebo three times per day for 12 consecutive weeks.
11274575|NCT02752880|BG002|Baseline|Total|Total of all reporting groups
11274576|NCT02752880|FG000|Participant Flow|YH1 Three Times Per Day for 12 Consecutive Weeks|The YH1 in one batch number was used, manufactured by a renowned GMP manufacturer of concentrated herbal extracts conforming to international standards.
11274577|NCT02752880|FG001|Participant Flow|Placebo|"placebo three times per day for 12 consecutive weeks.~placebo"
11274578|NCT02752880|OG000|Outcome|YH1 Group|YH1 three times per day for 12 consecutive weeks.
11274579|NCT02752880|OG001|Outcome|Placebo Group|placebo three times per day for 12 consecutive weeks.
11274580|NCT02752880|OG001|Outcome|Placebo|placebo three times per day for 12 consecutive weeks.
11274581|NCT02752880|EG000|Reported Event|YH1 Group|During 12 weeks of YH1 treatment, participants were encouraged to report any discomfort to the project manager throughout the trial. Adverse events including any undesirable or unintended symptoms were assessed regardless of the causal relationship with the study drug.
11274582|NCT02752880|EG001|Reported Event|Placebo Group|During 12 weeks of placebo treatment, participants were encouraged to report any discomfort to the project manager throughout the trial. Adverse events including any undesirable or unintended symptoms were assessed regardless of the causal relationship with the study drug.
11274583|NCT02752958|BG000|Baseline|Stannous Fluoride|Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
11274584|NCT02752958|FG000|Participant Flow|Overall Study: Stannous Fluoride|This was a non-comparative design study, all the participants applied dentifrice containing 0.454% weight by weight (w/w) stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
11274585|NCT02752958|OG000|Outcome|Stannous Fluoride|All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
11274586|NCT02752958|OG000|Outcome|Stannous Fluoride|This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
11274587|NCT02752958|OG000|Outcome|Stannous Fluoride|Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
11274588|NCT02752958|EG000|Reported Event|Stannous Fluoride|Participants will brush with a full brush head of toothpaste for 1 timed minute (in their usual manner), twice daily (morning and evening) from baseline
11274589|NCT02753075|BG000|Baseline|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274590|NCT02753075|BG001|Baseline|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274591|NCT02753075|BG002|Baseline|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274592|NCT02753075|BG003|Baseline|Total|Total of all reporting groups
11274593|NCT02753075|FG000|Participant Flow|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F]) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274594|NCT02753075|FG001|Participant Flow|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274595|NCT02753075|FG002|Participant Flow|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274596|NCT02753075|OG000|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274597|NCT02753075|OG001|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274598|NCT02753075|OG002|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274599|NCT02753075|OG000|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274600|NCT02753075|EG000|Reported Event|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F], pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274601|NCT02753075|EG001|Reported Event|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F, pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274602|NCT02753075|EG002|Reported Event|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
11274603|NCT02753400|BG000|Baseline|Emixustat Hydrochloride|"Week 1- Four tablets (2 placebo, 2 emixustat HCl Strength A)~Week 2- Four tablets (2 placebo, 2 emixustat HCl Strength B)~Week 3- Four tablets (2 placebo, 2 emixustat HCl Strength C)~Week 4- Four emixustat HCl tablets (Strength C)~All tablets are administered orally once daily. After week 4, all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen.~emixustat hydrochloride: Tablet for oral administration~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274604|NCT02753400|BG001|Baseline|Placebo|"Four placebo tablets are administered orally once daily for 12 weeks; Subjects in the placebo group will be mock-titrated on the same schedule as those in the active arm.~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274605|NCT02753400|BG002|Baseline|Total|Total of all reporting groups
11274606|NCT02753400|FG000|Participant Flow|Emixustat Hydrochloride|"Week 1- Four tablets (2 placebo, 2 emixustat HCl Strength A)~Week 2- Four tablets (2 placebo, 2 emixustat HCl Strength B)~Week 3- Four tablets (2 placebo, 2 emixustat HCl Strength C)~Week 4- Four emixustat HCl tablets (Strength C)~All tablets are administered orally once daily. After week 4, all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen.~emixustat hydrochloride: Tablet for oral administration~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274607|NCT02753400|FG001|Participant Flow|Placebo|"Four placebo tablets are administered orally once daily for 12 weeks; Subjects in the placebo group will be mock-titrated on the same schedule as those in the active arm.~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274608|NCT02753400|OG000|Outcome|Emixustat Hydrochloride|"Week 1- Four tablets (2 placebo, 2 emixustat HCl Strength A)~Week 2- Four tablets (2 placebo, 2 emixustat HCl Strength B)~Week 3- Four tablets (2 placebo, 2 emixustat HCl Strength C)~Week 4- Four emixustat HCl tablets (Strength C)~All tablets are administered orally once daily. After week 4, all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen.~emixustat hydrochloride: Tablet for oral administration~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
10847393|NCT00283062|FG000|Participant Flow|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11274609|NCT02753400|OG001|Outcome|Placebo|"Four placebo tablets are administered orally once daily for 12 weeks; Subjects in the placebo group will be mock-titrated on the same schedule as those in the active arm.~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274610|NCT02753400|EG000|Reported Event|Emixustat Hydrochloride|"Week 1- Four tablets (2 placebo, 2 emixustat HCl Strength A)~Week 2- Four tablets (2 placebo, 2 emixustat HCl Strength B)~Week 3- Four tablets (2 placebo, 2 emixustat HCl Strength C)~Week 4- Four emixustat HCl tablets (Strength C)~All tablets are administered orally once daily. After week 4, all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen.~emixustat hydrochloride: Tablet for oral administration~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274611|NCT02753400|EG001|Reported Event|Placebo|"Four placebo tablets are administered orally once daily for 12 weeks; Subjects in the placebo group will be mock-titrated on the same schedule as those in the active arm.~Placebo: Placebo tablets for oral administration contain only inactive ingredients"
11274612|NCT02753413|BG000|Baseline|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274613|NCT02753413|BG001|Baseline|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274614|NCT02753413|BG002|Baseline|Total|Total of all reporting groups
11274615|NCT02753413|FG000|Participant Flow|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274616|NCT02753413|FG001|Participant Flow|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274617|NCT02753413|OG000|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274618|NCT02753413|OG001|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274619|NCT02753413|EG000|Reported Event|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274620|NCT02753413|EG001|Reported Event|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
11274621|NCT02753595|BG000|Baseline|Phase 1b: Dose Level 1|Participants received PEGPH20 3.0 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
11274622|NCT02753595|BG001|Baseline|Phase 1b: Dose Level 0 and Expansion Part|Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
11274623|NCT02753595|BG002|Baseline|Total|Total of all reporting groups
11274624|NCT02753595|FG000|Participant Flow|Phase 1b: Dose Level 1|Participants received PEGylated recombinant human hyaluronidase (PEGPH20) 3.0 microgram per kilogram (mcg/kg), infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 milligram per square meter (mg/m^2), infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
11274625|NCT02753595|FG001|Participant Flow|Phase 1b: Dose Level 0 and Expansion Part|Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
11274626|NCT02753595|OG000|Outcome|Phase 1b, All Participants|Participants received PEGPH20 3.0 mcg/kg or 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of first 21-day treatment cycle. After the determination of RP2D in Cycle 1 of Phase 1b, additional participants were enrolled for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
11274627|NCT02753595|EG000|Reported Event|Phase 1b: Dose Level 1|Participants received PEGPH20 3.0 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
11274628|NCT02753595|EG001|Reported Event|Phase 1b: Dose Level 0 and Expansion Part|Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
11274629|NCT02753699|BG000|Baseline|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
11274630|NCT02753699|BG001|Baseline|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
11274631|NCT02753699|BG002|Baseline|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
11274632|NCT02753699|BG003|Baseline|Total|Total of all reporting groups
11274633|NCT02753699|FG000|Participant Flow|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
11274634|NCT02753699|FG001|Participant Flow|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
11274635|NCT02753699|FG002|Participant Flow|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
11274636|NCT02753699|OG000|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
11274637|NCT02753699|OG001|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
11274638|NCT02753699|OG002|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
11274639|NCT02753699|OG003|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
11274640|NCT02753699|EG000|Reported Event|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
11274641|NCT02753699|EG001|Reported Event|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
11274642|NCT02753699|EG002|Reported Event|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
11274643|NCT02753699|EG003|Reported Event|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
11274644|NCT02753816|BG000|Baseline|Tranexamic Acid|"1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery~Tranexamic Acid"
11274645|NCT02753816|BG001|Baseline|Placebo|"Placebo given over 10 minutes into the vein once prior to surgery~Placebo Comparator"
11274646|NCT02753816|BG002|Baseline|Tranexamic Acid and Placebo|(see participant flow)
11274647|NCT02753816|BG003|Baseline|Total|Total of all reporting groups
11274648|NCT02753816|FG000|Participant Flow|Tranexamic Acid|"1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery~Tranexamic Acid"
11274649|NCT02753816|FG001|Participant Flow|Placebo|"Placebo given over 10 minutes into the vein once prior to surgery~Placebo Comparator"
11274650|NCT02753816|FG002|Participant Flow|Tranexamic Acid and Placebo|Patients whom received Tranexamic Acid during one surgery and Placebo in another surgery
11274651|NCT02753816|OG000|Outcome|Tranexamic Acid|"1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery~Tranexamic Acid"
11274652|NCT02753816|OG001|Outcome|Placebo|"Placebo given over 10 minutes into the vein once prior to surgery~Placebo Comparator"
11274653|NCT02753816|EG000|Reported Event|Tranexamic Acid|"1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery~Tranexamic Acid"
11274654|NCT02753816|EG001|Reported Event|Placebo|"Placebo given over 10 minutes into the vein once prior to surgery~Placebo Comparator"
11274655|NCT02753842|BG000|Baseline|Fitted, Then Thin, Then Standard Condoms|Fitted, Then Thin, Then Standard Condoms.
11274656|NCT02753842|BG001|Baseline|Fitted, Then Standard, Then Thin Condoms|Fitted, Then Standard, Then Thin Condoms.
11274657|NCT02753842|BG002|Baseline|Thin, Then Fitted, Then Standard Condoms|Thin, Then Fitted, Then Standard Condoms.
11274658|NCT02753842|BG003|Baseline|Thin, Then Standard, Then Fitted Condoms|Thin, Then Standard, Then Fitted Condoms.
11274659|NCT02753842|BG004|Baseline|Standard, Then Fitted, Then Thin Condoms|Standard, Then Fitted, Then Thin Condoms.
11274660|NCT02753842|BG005|Baseline|Standard, Then Thin, Then Fitted Condoms|Standard, Then Thin, Then Fitted Condoms.
11274661|NCT02753842|BG006|Baseline|Total|Total of all reporting groups
11274662|NCT02753842|FG000|Participant Flow|Fitted, Then Thin, Then Standard Condoms|Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
11274663|NCT02753842|FG001|Participant Flow|Fitted, Then Standard, Then Thin Condoms|Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
11274664|NCT02753842|FG002|Participant Flow|Thin, Then Fitted, Then Standard Condoms|Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
11274665|NCT02753842|FG003|Participant Flow|Thin, Then Standard, Then Fitted Condoms|Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.
11274666|NCT02753842|FG004|Participant Flow|Standard, Then Fitted, Then Thin Condoms|Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
11274667|NCT02753842|FG005|Participant Flow|Standard, Then Thin, Then Fitted Condoms|Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.
11274668|NCT02753842|OG000|Outcome|Fitted Condoms|Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
11274669|NCT02753842|OG001|Outcome|Standard Condoms|Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
11274670|NCT02753842|OG000|Outcome|Condom Preference (Binary)|Preference for fitted or standard condoms at the end of the study. Participants were blinded to condom type.
11274671|NCT02753842|OG000|Outcome|Fitted Condoms|Fitted condoms used for anal sex
11274672|NCT02753842|OG001|Outcome|Thin Condoms|Thin condoms used for anal sex
11274673|NCT02753842|OG002|Outcome|Standard Condoms|Standard condoms used for anal sex
11274674|NCT02753842|OG000|Outcome|Fitted Condoms Used for Anal Sex|Fitted condom clinical failure when used for anal sex
11274675|NCT02753842|OG001|Outcome|Standard Condoms Used for Anal Sex|Standard condom clinical failure when used for anal sex
11274676|NCT02753842|OG000|Outcome|Thin Condoms|Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
11274677|NCT02753842|EG000|Reported Event|Fitted Condoms|Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non- sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
11274678|NCT02753842|EG001|Reported Event|Thin Condoms|Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
11274679|NCT02753842|EG002|Reported Event|Standard Condoms|Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
11274680|NCT02753881|BG000|Baseline|Superselective cTACE Doxorubicin (One Segment)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment."
11274681|NCT02753881|BG001|Baseline|Superselective cTACE (2+ Segments)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments."
11274682|NCT02753881|BG002|Baseline|Whole Liver Lobe cTACE Doxorubicin|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.~whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe."
11274683|NCT02753881|BG003|Baseline|Total|Total of all reporting groups
11274684|NCT02753881|FG000|Participant Flow|Superselective cTACE Doxorubicin (One Segment)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment."
11274685|NCT02753881|FG001|Participant Flow|Superselective cTACE (2+ Segments)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments."
11274686|NCT02753881|FG002|Participant Flow|Whole Liver Lobe cTACE Doxorubicin|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.~whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe."
11274687|NCT02753881|OG000|Outcome|Superselective cTACE Doxorubicin (One Segment)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment."
11274688|NCT02753881|OG001|Outcome|Superselective cTACE (2+ Segments)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments."
11274689|NCT02753881|OG002|Outcome|Whole Liver Lobe cTACE Doxorubicin|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.~whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe."
11274690|NCT02753881|EG000|Reported Event|Superselective cTACE Doxorubicin (One Segment)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment."
11274691|NCT02753881|EG001|Reported Event|Superselective cTACE (2+ Segments)|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.~superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments."
11274692|NCT02753881|EG002|Reported Event|Whole Liver Lobe cTACE Doxorubicin|"Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.~whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe."
11274693|NCT02753920|BG000|Baseline|Retrograde Fill Voiding Trial Method|"Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter."
11274694|NCT02753920|BG001|Baseline|Force of Stream (FAST) Voiding Trial Method|"Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is <500cc, patient discharged w/o catheter; if PVR is >/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter."
11274695|NCT02753920|BG002|Baseline|Total|Total of all reporting groups
11274696|NCT02753920|FG000|Participant Flow|Retrograde Fill Voiding Trial Method|"Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 min (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV (trial of void): 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling. catheter: If subject unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter."
11274697|NCT02753920|FG001|Participant Flow|Force of Stream (FAST) Voiding Trial Method|Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 minutes (if unable to void after 20 minutes, discharged home w/ a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR (postvoid residual). If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is <500cc, the patient will be discharged without a catheter; if PVR is >/=500cc, the patient will be discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately
11274698|NCT02753920|OG000|Outcome|Retrograde Fill Voiding Trial Method|"Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter."
11274699|NCT02753920|OG001|Outcome|Force of Stream (FAST) Voiding Trial Method|"Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is <500cc, patient discharged w/o catheter; if PVR is >/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter."
11274700|NCT02753920|OG000|Outcome|Retrograde Fill Voiding Trial Method|"Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 min (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling. catheter: If subject unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter."
11274701|NCT02753920|OG001|Outcome|Force of Stream (FAST) Voiding Trial Method|Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 minutes (if unable to void after 20 minutes, discharged home w/ a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR. If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is <500cc, the patient will be discharged without a catheter; if PVR is >/=500cc, the patient will be discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately
11286870|NCT02895100|FG000|Participant Flow|PTG-100 (150 mg QD)|"Low dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286871|NCT02895100|FG001|Participant Flow|PTG-100 (300 mg QD)|"Medium dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274702|NCT02753920|OG000|Outcome|Force of Stream (FAST) Voiding Trial Method|Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 minutes (if unable to void after 20 minutes, discharged home w/ a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR. If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is <500cc, the patient will be discharged without a catheter; if PVR is >/=500cc, the patient will be discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately
11274703|NCT02753920|OG001|Outcome|Retrograde Fill Voiding Trial Method|"Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 min (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids >/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling. catheter: If subject unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter."
11274704|NCT02753920|EG000|Reported Event|Retrograde Fill Voiding Trial Method|"Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids w/in 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however information will only be used for research purposes).~If she voids >/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids <200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.~TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The sub"
11274705|NCT02753920|EG001|Reported Event|Force of Stream (FAST) Voiding Trial Method|"Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter is removed Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale >/=50 (>/=50%) catheter will remain out, patient discharged home without measuring a PVR. If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is <500cc, the patient will be discharged without a catheter; if PVR is >/=500cc, patient discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.~voiding trial: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling~Foley catheter: If subject is unable to void adequately"
11274706|NCT02753946|BG000|Baseline|ZTI-01|"6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days)~ZTI-01: 6g ZTI-01 intravenous infusion TID q8 hours"
11274707|NCT02753946|BG001|Baseline|Piperacillin Tazobactam|"4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days)~Piperacillin-tazobactam: 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours"
11274708|NCT02753946|BG002|Baseline|Total|Total of all reporting groups
11274709|NCT02753946|FG000|Participant Flow|ZTI-01|"6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days)~ZTI-01: 6g ZTI-01 intravenous infusion TID q8 hours"
11274710|NCT02753946|FG001|Participant Flow|Piperacillin Tazobactam|"4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days)~Piperacillin-tazobactam: 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours"
11274711|NCT02753946|OG000|Outcome|ZTI-01|"6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days)~ZTI-01: 6g ZTI-01 intravenous infusion TID q8 hours"
11274712|NCT02753946|OG001|Outcome|Piperacillin Tazobactam|"4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days)~Piperacillin-tazobactam: 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours"
11274713|NCT02753946|EG000|Reported Event|ZTI-01|"6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days)~ZTI-01: 6g ZTI-01 intravenous infusion TID q8 hours"
11274714|NCT02753946|EG001|Reported Event|Piperacillin Tazobactam|"4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days)~Piperacillin-tazobactam: 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours"
11274715|NCT02754310|BG000|Baseline|Varied Scenarios|"Participants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the repeated scenarios group. In this group, there is a variation of scenarios.~Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation."
11274716|NCT02754310|BG001|Baseline|Repeated Scenarios|"Participants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, .~Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times."
11274717|NCT02754310|BG002|Baseline|Total|Total of all reporting groups
11286872|NCT02895100|FG002|Participant Flow|PTG-100 (900 mg QD)|"High dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286873|NCT02895100|FG003|Participant Flow|Placebo Group|"Placebo control~Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period."
11274718|NCT02754310|FG000|Participant Flow|Varied Scenarios|"Participants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the repeated scenarios group. In this group, there is a variation of scenarios.~Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation."
11274719|NCT02754310|FG001|Participant Flow|Repeated Scenarios|"Participants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, .~Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times."
11274720|NCT02754310|OG000|Outcome|Varied Scenarios|"Participants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the repeated scenarios group. In this group, there is a variation of scenarios.~Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation."
11274721|NCT02754310|OG001|Outcome|Repeated Scenarios|"Participants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, .~Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times."
11274722|NCT02754310|EG000|Reported Event|Repeated Scenarios|"Participants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, .~Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times."
11274723|NCT02754310|EG001|Reported Event|Varied Scenarios|"Participants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the repeated scenarios group. In this group, there is a variation of scenarios.~Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation."
11274724|NCT02754427|BG000|Baseline|Prospective Surveillance Group|"Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.~Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved."
11274725|NCT02754427|BG001|Baseline|Education Group|"Participants in the education group received the usual post-operative follow-up.~Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff."
11274726|NCT02754427|BG002|Baseline|Total|Total of all reporting groups
11274727|NCT02754427|FG000|Participant Flow|Prospective Surveillance Group|"Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.~Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved."
11274728|NCT02754427|FG001|Participant Flow|Education Group|"Participants in the education group received the usual post-operative follow-up.~Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff."
11274729|NCT02754427|OG000|Outcome|Prospective Surveillance Group|"Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.~Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved."
11274730|NCT02754427|OG001|Outcome|Education Group|"Participants in the education group received the usual post-operative follow-up.~Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff."
11286874|NCT02895100|OG000|Outcome|PTG-100 (150 mg QD)|"Low dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286875|NCT02895100|OG001|Outcome|PTG-100 (300 mg QD)|"Medium dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274731|NCT02754427|EG000|Reported Event|Prospective Surveillance Group|"Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.~Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved."
11274732|NCT02754427|EG001|Reported Event|Education Group|"Participants in the education group received the usual post-operative follow-up.~Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff."
11274733|NCT02754440|BG000|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274734|NCT02754440|BG001|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274735|NCT02754440|BG002|Baseline|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274736|NCT02754440|BG003|Baseline|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
11274737|NCT02754440|BG004|Baseline|Total|Total of all reporting groups
11274738|NCT02754440|FG000|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274739|NCT02754440|FG001|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274740|NCT02754440|FG002|Participant Flow|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274741|NCT02754440|FG003|Participant Flow|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
11274742|NCT02754440|OG000|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274743|NCT02754440|OG001|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274744|NCT02754440|OG002|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274745|NCT02754440|EG000|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274746|NCT02754440|EG001|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274747|NCT02754440|EG002|Reported Event|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274748|NCT02754440|EG003|Reported Event|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
11286876|NCT02895100|OG002|Outcome|PTG-100 (900 mg QD)|"High dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274749|NCT02754492|BG000|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274750|NCT02754492|BG001|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274751|NCT02754492|BG002|Baseline|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274752|NCT02754492|BG003|Baseline|Unassigned|Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
10847394|NCT00283062|FG001|Participant Flow|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11274753|NCT02754492|BG004|Baseline|Total|Total of all reporting groups
11274754|NCT02754492|FG000|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274755|NCT02754492|FG001|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274756|NCT02754492|FG002|Participant Flow|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11286877|NCT02895100|OG003|Outcome|Placebo Group|"Placebo control~Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period."
11092301|NCT01539070|OG001|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
11214783|NCT02294396|BG001|Baseline|Mirabegron + Propiverine|Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective.
11214784|NCT02294396|BG002|Baseline|Mirabegron + Imidafenacin|Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective.
11214785|NCT02294396|BG003|Baseline|Mirabegron + Tolterodine|Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks.
11214786|NCT02294396|BG004|Baseline|Total|Total of all reporting groups
11214787|NCT02294396|FG000|Participant Flow|Mirabegron + Solifenacin|Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective.
11214788|NCT02294396|FG001|Participant Flow|Mirabegron + Propiverine|Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective.
11214789|NCT02294396|FG002|Participant Flow|Mirabegron + Imidafenacin|Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective.
11214790|NCT02294396|FG003|Participant Flow|Mirabegron + Tolterodine|Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks.
11214791|NCT02294396|OG000|Outcome|Mirabegron + Solifenacin|Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective.
11214792|NCT02294396|OG001|Outcome|Mirabegron + Propiverine|Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective.
11214793|NCT02294396|OG002|Outcome|Mirabegron + Imidafenacin|Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective.
11214794|NCT02294396|OG003|Outcome|Mirabegron + Tolterodine|Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks.
11214795|NCT02294396|EG000|Reported Event|Mirabegron + Solifenacin|Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective.
11214796|NCT02294396|EG001|Reported Event|Mirabegron + Propiverine|Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective.
11214797|NCT02294396|EG002|Reported Event|Mirabegron + Imidafenacin|Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective.
11214798|NCT02294396|EG003|Reported Event|Mirabegron + Tolterodine|Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks.
11214799|NCT02294474|BG000|Baseline|SAR342434|SAR342434 100 U/mL subcutaneous (SC) injection before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
11214800|NCT02294474|BG001|Baseline|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214801|NCT02294474|BG002|Baseline|Total|Total of all reporting groups
11214802|NCT02294474|FG000|Participant Flow|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214803|NCT02294474|FG001|Participant Flow|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214804|NCT02294474|OG000|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214805|NCT02294474|OG001|Outcome|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214806|NCT02294474|OG000|Outcome|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine up to Week 26.
11214807|NCT02294474|EG000|Reported Event|SAR342434|SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214808|NCT02294474|EG001|Reported Event|Humalog|Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
11214809|NCT02294604|BG000|Baseline|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
11214810|NCT02294604|BG001|Baseline|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
11214811|NCT02294604|BG002|Baseline|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
11214812|NCT02294604|BG003|Baseline|Total|Total of all reporting groups
11214813|NCT02294604|FG000|Participant Flow|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
11274757|NCT02754492|FG003|Participant Flow|Unassigned|Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
11274758|NCT02754492|OG000|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274759|NCT02754492|OG001|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274760|NCT02754492|OG002|Outcome|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274761|NCT02754492|EG000|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274762|NCT02754492|EG001|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274763|NCT02754492|EG002|Reported Event|Triple Platelet Product|"Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections~Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure"
11274764|NCT02754492|EG003|Reported Event|Unassigned|Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
11274765|NCT02754518|BG000|Baseline|Open Label Entresto|"All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care.~Entresto"
11274766|NCT02754518|FG000|Participant Flow|Open Label Entresto|"All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care.~Entresto"
11274767|NCT02754518|OG000|Outcome|Open Label Entresto|"All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care.~Entresto"
11274768|NCT02754518|EG000|Reported Event|Open Label Entresto|REMODEL is a prospective, single-arm longitudinal study investigating the structural, neurohormonal and functional effects of sacubitril/valsartan. Patients with New York Heart Association (NYHA) Class II-III HFrEF who were on optimal guideline directed medical therapy for at least three months with an LVEF between 20-40% who otherwise met inclusion and exclusion criteria similar to that of the Paradigm Trial were eligible for enrollment.
11274769|NCT02754570|BG000|Baseline|Pilocarpine Group|"Subjects with open-angle glaucoma and ocular hypertension.~Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost."
10847395|NCT00283062|FG002|Participant Flow|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
11274770|NCT02754570|FG000|Participant Flow|Pilocarpine Group|"Subjects with open-angle glaucoma and ocular hypertension.~Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost."
11274771|NCT02754570|OG000|Outcome|Pilocarpine Group|"Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.~Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost or brimonidine"
11274772|NCT02754570|OG000|Outcome|Pilocarpine Group|"Subjects with open-angle glaucoma, ocular hypertension or psuedoexfoliation glaucoma.~Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost."
11274773|NCT02754570|EG000|Reported Event|Pilocarpine Group|"Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.~Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost."
11274774|NCT02754570|EG001|Reported Event|PGA Monotherapy|"Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.~PGA: Latanoprost or Bimatoprost administered one time per day."
11274775|NCT02754661|BG000|Baseline|COLON Capsule Endoscopy|Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.
11274776|NCT02754661|BG001|Baseline|Computed Tomographic Colonography|Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
11274777|NCT02754661|BG002|Baseline|Total|Total of all reporting groups
11274778|NCT02754661|FG000|Participant Flow|COLON Capsule Endoscopy|Subjects who had Colon capsule followed by optical colonoscopy within 5-6 weeks.
11274779|NCT02754661|FG001|Participant Flow|Computed Tomographic Colonography|Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
11274780|NCT02754661|OG000|Outcome|COLON CAPSULE ENDOSCOPY|Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.
11274781|NCT02754661|OG001|Outcome|Computed Tomographic Colonography|Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
11274782|NCT02754661|OG000|Outcome|COLON Capsule Endoscopy|Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.
11274783|NCT02754661|OG001|Outcome|Computed Tomographic Colonography|Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
11274784|NCT02754661|EG000|Reported Event|COLON Capsule Endoscopy|Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.
11274785|NCT02754661|EG001|Reported Event|Computed Tomographic Colonography|Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
11274786|NCT02754674|BG000|Baseline|Transportal|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation"
11274787|NCT02754674|BG001|Baseline|Outside in|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation"
11274788|NCT02754674|BG002|Baseline|Total|Total of all reporting groups
11274789|NCT02754674|FG000|Participant Flow|Transportal|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274790|NCT02754674|FG001|Participant Flow|Outside in|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274791|NCT02754674|OG000|Outcome|Transportal|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274792|NCT02754674|OG001|Outcome|Outside in|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274793|NCT02754674|EG000|Reported Event|Transportal|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274794|NCT02754674|EG001|Reported Event|Outside in|"this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique~type of anterior cruciate ligament reconstruction: comparison of different types of anterior cruciate ligament reconstruction.~transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation."
11274795|NCT02755090|BG000|Baseline|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
11274796|NCT02755090|BG001|Baseline|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
11274797|NCT02755090|BG002|Baseline|Total|Total of all reporting groups
11274798|NCT02755090|FG000|Participant Flow|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
11274799|NCT02755090|FG001|Participant Flow|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
11286878|NCT02895100|EG000|Reported Event|PTG-100 (150 mg QD)|"Low dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11286879|NCT02895100|EG001|Reported Event|PTG-100 (300 mg QD)|"Medium dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274800|NCT02755090|OG000|Outcome|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
11274801|NCT02755090|OG001|Outcome|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
11274802|NCT02755090|EG000|Reported Event|Nitrous Oxide and IV Saline|"Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.~IV Saline"
11274803|NCT02755090|EG001|Reported Event|Standard Care Group (IV Sedation and Oxygen)|Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
11274804|NCT02755116|BG000|Baseline|Olanzapine|10mg of olanzapine by mouth prior to anesthetic induction
11274805|NCT02755116|BG001|Baseline|Placebo|placebo by mouth prior to anesthetic induction
11274806|NCT02755116|BG002|Baseline|Total|Total of all reporting groups
11274807|NCT02755116|FG000|Participant Flow|Olanzapine|10-mg dose of olanzapine by mouth prior to anesthetic induction
11274808|NCT02755116|FG001|Participant Flow|Placebo|placebo by mouth prior to anesthetic induction
11274809|NCT02755116|OG000|Outcome|Olanzapine|10-mg dose of olanzapine by mouth prior to anesthetic induction
11274810|NCT02755116|OG001|Outcome|Placebo|placebo by mouth prior to anesthetic induction
11274811|NCT02755116|EG000|Reported Event|Olanzapine|10-mg dose of olanzapine by mouth prior to anesthetic induction
11274812|NCT02755116|EG001|Reported Event|Placebo|placebo by mouth prior to anesthetic induction
11274813|NCT02755129|BG000|Baseline|All Study Participants|"Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises.~On arrival to the rehabilitation center, subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:~Walking exercises - Six Minute Walk (6MW) Test~Walking exercises - 4 Meter Gait Speed (4MGS) Test~Walking Exercises - Five Times Sit to Stand (FTSTS) Test~Walking Exercises - Expanded Timed Get-Up-and-Go (ETGUG) Test"
11274814|NCT02755129|FG000|Participant Flow|All Study Participants|"Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises.~On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:~Walking exercises - Six Minute Walk (6MW) Test~Walking exercises - 4 Meter Gait Speed (4MGS) Test~Walking Exercises - Five Times Sit to Stand (FTSTS) Test~Walking Exercises - Expanded Timed Get-Up-and-Go (ETGUG) Test"
11274815|NCT02755129|OG000|Outcome|Correlation Coefficient - Six Minute Walk (6MW) Test|Patients with Chronic Heart Failure. No control group used. All patients enrolled performed the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, the correlation coefficient for gait speed across devices for Six Minute Walk (6MW) Test is calculated.
11274816|NCT02755129|OG001|Outcome|Correlation Coefficient - 4 Meter Gait Speed (4MGS) Test|Patients with Chronic Heart Failure. No control group used. All patients enrolled performed the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, the correlation coefficient for gait speed across devices for 4 Meter Gait Speed (4MGS) Test is calculated.
11274817|NCT02755129|OG002|Outcome|Correlation Coefficient - Five Times Sit to Stand (FTSTS) Test|Patients with Chronic Heart Failure. No control group used. All patients enrolled performed the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, the correlation coefficient for gait speed across devices for Five Times Sit to Stand (FTSTS) Test is calculated.
11092302|NCT01539070|EG000|Reported Event|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
11274818|NCT02755129|OG003|Outcome|Correlation Coefficient - ETGUG Test|Patients with Chronic Heart Failure. No control group used. All patients enrolled performed the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, the correlation coefficient for gait speed across devices for Expanded Timed Get-Up-and-Go (ETGUG) Test is calculated.
11274819|NCT02755129|EG000|Reported Event|All Study Participants|"Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises.~On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:~Walking exercises - Six Minute Walk (6MW) Test~Walking exercises - 4 Meter Gait Speed (4MGS) Test~Walking Exercises - Five Times Sit to Stand (FTSTS) Test~Walking Exercises - Expanded Timed Get-Up-and-Go (ETGUG) Test"
11274820|NCT02755285|BG000|Baseline|Single Endoscopy Procedure|"All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.~Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject."
11274821|NCT02755285|FG000|Participant Flow|Single Endoscopy Procedure|"All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.~Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject."
11274822|NCT02755285|OG000|Outcome|Single Endoscopy Procedure|All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
11274823|NCT02755285|EG000|Reported Event|Single Endoscopy Procedure|"All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.~Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject."
11274824|NCT02755649|BG000|Baseline|Placebo QW + TCS|Participants received one subcutaneous (SC) injection of matching placebo once per week (QW) (following two SC injections on day 1) from Week 1 to Week 15. All participants required to undergo treatment with topical corticosteroids (TCS) using standardized regimen that continued through the end of treatment period (Week 16). At week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274825|NCT02755649|BG001|Baseline|Dupilumab 300 mg Q2W + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg every 2 weeks (Q2W) from Week 1 to Week 15 (following a SC loading dose of 600 mg on day 1). During weeks in which dupilumab was not administered, participants received matching placebo. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274826|NCT02755649|BG002|Baseline|Dupilumab 300 mg QW + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg once per week (QW) (following an SC loading dose of 600 mg on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274827|NCT02755649|BG003|Baseline|Total|Total of all reporting groups
11274828|NCT02755649|FG000|Participant Flow|Placebo QW + TCS|Participants received one subcutaneous (SC) injection of matching placebo once per week (QW) (following two SC injections on day 1) from Week 1 to Week 15. All participants required to undergo treatment with topical corticosteroids (TCS) using standardized regimen that continued through the end of treatment period (Week 16). At week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274829|NCT02755649|FG001|Participant Flow|Dupilumab 300 mg Q2W + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg every 2 weeks (Q2W) from Week 1 to Week 15 (following a SC loading dose of 600 mg on day 1). During weeks in which dupilumab was not administered, participants received matching placebo. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11214814|NCT02294604|FG001|Participant Flow|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
11214815|NCT02294604|FG002|Participant Flow|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
11214816|NCT02294604|OG000|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
11214817|NCT02294604|OG001|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
11214818|NCT02294604|OG002|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
11214819|NCT02294604|EG000|Reported Event|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
11214820|NCT02294604|EG001|Reported Event|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
11214821|NCT02294604|EG002|Reported Event|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
11214822|NCT02294630|BG000|Baseline|Dose Schedule I|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214823|NCT02294630|BG001|Baseline|Dose Schedule II|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214824|NCT02294630|BG002|Baseline|Dose Schedule III|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214825|NCT02294630|BG003|Baseline|Dose Schedule IV|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214826|NCT02294630|BG004|Baseline|Total|Total of all reporting groups
11214827|NCT02294630|FG000|Participant Flow|Dose Schedule I|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214828|NCT02294630|FG001|Participant Flow|Dose Schedule II|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214829|NCT02294630|FG002|Participant Flow|Dose Schedule III|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214830|NCT02294630|FG003|Participant Flow|Dose Schedule IV|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214831|NCT02294630|OG000|Outcome|Dose Schedule I|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214832|NCT02294630|OG001|Outcome|Dose Schedule II|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214833|NCT02294630|OG002|Outcome|Dose Schedule III|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214834|NCT02294630|OG003|Outcome|Dose Schedule IV|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214835|NCT02294630|EG000|Reported Event|Dose Schedule I|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214836|NCT02294630|EG001|Reported Event|Dose Schedule II|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11274830|NCT02755649|FG002|Participant Flow|Dupilumab 300 mg QW + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg once per week (QW) (following an SC loading dose of 600 mg on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274831|NCT02755649|OG000|Outcome|Placebo QW + TCS|Participants received one subcutaneous (SC) injection of matching placebo once per week (QW) (following two SC injections on day 1) from Week 1 to Week 15. All participants required to undergo treatment with topical corticosteroids (TCS) using standardized regimen that continued through the end of treatment period (Week 16). At week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274832|NCT02755649|OG001|Outcome|Dupilumab 300 mg Q2W + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg every 2 weeks (Q2W) from Week 1 to Week 15 (following a SC loading dose of 600 mg on day 1). During weeks in which dupilumab was not administered, participants received matching placebo. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274833|NCT02755649|OG002|Outcome|Dupilumab 300 mg QW + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg once per week (QW) (following an SC loading dose of 600 mg on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274834|NCT02755649|EG000|Reported Event|Placebo QW + TCS|Participants received one subcutaneous (SC) injection of matching placebo once per week (QW) (following two SC injections on day 1) from Week 1 to Week 15. All participants required to undergo treatment with topical corticosteroids (TCS) using standardized regimen that continued through the end of treatment period (Week 16). At week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274835|NCT02755649|EG001|Reported Event|Dupilumab 300 mg Q2W + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg every 2 weeks (Q2W) from Week 1 to Week 15 (following a SC loading dose of 600 mg on day 1). During weeks in which dupilumab was not administered, participants received matching placebo. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274836|NCT02755649|EG002|Reported Event|Dupilumab 300 mg QW + TCS|Participants received one subcutaneous (SC) injection of dupilumab 300 mg once per week (QW) (following an SC loading dose of 600 mg on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety ([Week 28, end of study (EOS) period]).
11274837|NCT02755805|BG000|Baseline|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
11274838|NCT02755805|BG001|Baseline|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
11274839|NCT02755805|BG002|Baseline|Total|Total of all reporting groups
11274840|NCT02755805|FG000|Participant Flow|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
11274841|NCT02755805|FG001|Participant Flow|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
11274842|NCT02755805|OG000|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
11286880|NCT02895100|EG002|Reported Event|PTG-100 (900 mg QD)|"High dose~PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period."
11274843|NCT02755805|OG001|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
11274844|NCT02755805|EG000|Reported Event|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
11274845|NCT02755805|EG001|Reported Event|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
11274846|NCT02755818|BG000|Baseline|Control|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274847|NCT02755818|BG001|Baseline|Chronic Renal Disease (CKD3b)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 30-45~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274848|NCT02755818|BG002|Baseline|Chronic Renal Disease (CKD4)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 15-30~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274849|NCT02755818|BG003|Baseline|Chronic Renal Disease (CKD5)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274850|NCT02755818|BG004|Baseline|Total|Total of all reporting groups
11274851|NCT02755818|FG000|Participant Flow|Control|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274852|NCT02755818|FG001|Participant Flow|Chronic Renal Disease (CKD3b)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274853|NCT02755818|FG002|Participant Flow|Chronic Renal Disease (CKD4)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274854|NCT02755818|FG003|Participant Flow|Chronic Renal Disease (CKD5)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274855|NCT02755818|OG000|Outcome|Control|Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
11274856|NCT02755818|OG001|Outcome|Chronic Kidney Disease, Stage 5 (CKD5)|Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
11274857|NCT02755818|OG002|Outcome|Chronic Kidney Disease 4 (CKD4)|Subject has glomerular filtration rate (GFR) of 15-29 cc/min
11274858|NCT02755818|OG003|Outcome|Chronic Kidney Disease Stage 3b (CKD 3b)|Subject has glomerular filtration rate (GFR) of 30-45 cc/min
11274859|NCT02755818|OG002|Outcome|Chronic Kidney Disease, Stage 4 (CKD4)|Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease
11274860|NCT02755818|OG003|Outcome|Chronic Kidney Disease, Stage 3b (CKD3b)|Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function
11274861|NCT02755818|EG000|Reported Event|Control|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274862|NCT02755818|EG001|Reported Event|Chronic Renal Disease (CKD3b)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274863|NCT02755818|EG002|Reported Event|Chronic Renal Disease (CKD4)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274864|NCT02755818|EG003|Reported Event|Chronic Renal Disease (CKD5)|"heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis~Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements"
11274865|NCT02755831|BG000|Baseline|Sleep Study + CPAP Group|"Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment~CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea"
11274866|NCT02755831|BG001|Baseline|Standard Prenatal Care Group|"Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.~Pre-natal care: Standard Pre-Natal Care"
11274867|NCT02755831|BG002|Baseline|Total|Total of all reporting groups
11274868|NCT02755831|FG000|Participant Flow|Sleep Study + CPAP Group|"Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment~CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea"
11274869|NCT02755831|FG001|Participant Flow|Standard Prenatal Care Group|"Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.~Pre-natal care: Standard Pre-Natal Care"
11274870|NCT02755831|OG000|Outcome|Sleep Study + CPAP Group|"Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment~CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea"
11274871|NCT02755831|OG001|Outcome|Standard Prenatal Care Group|"Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.~Pre-natal care: Standard Pre-Natal Care"
11274872|NCT02755831|EG000|Reported Event|Sleep Study + CPAP Group|"Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment~CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea"
11274873|NCT02755831|EG001|Reported Event|Standard Prenatal Care Group|"Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.~Pre-natal care: Standard Pre-Natal Care"
11274874|NCT02755935|BG000|Baseline|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
11274875|NCT02755935|FG000|Participant Flow|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
11274876|NCT02755935|OG000|Outcome|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
11274877|NCT02755935|EG000|Reported Event|Implanted|"Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant~Cochlear Nucleus CI532: cochlear implantation"
11274882|NCT02756078|BG000|Baseline|All Enrolled Subjects|All subjects enrolled in the study, i.e. signed informed consent form.
11274883|NCT02756078|FG000|Participant Flow|Senofilcon A/Samfilcon A|All subjects that received the senofilcon A lens during the first period and the samfilcon A lens during the second period.
11274884|NCT02756078|FG001|Participant Flow|Samfilcon A/Senofilcon A|All subjects that received the samfilcon A lens during the first period and the senofilcon A lens during the second period.
11274885|NCT02756078|OG000|Outcome|Senofilcon A|All subjects that wore the senofilcon A lens during either the first or second period of the study.
11274886|NCT02756078|OG001|Outcome|Samfilcon A|All subjects that wore the samfilcon A lens during either the first or second period of the study.
11274887|NCT02756078|EG000|Reported Event|Senofilcon A|All subjects that wore the senofilcon A lens during either the first or second period of the study.
11274888|NCT02756078|EG001|Reported Event|Samfilcon A|All subjects that wore the samfilcon A lens during either period of the study.
11274889|NCT02756182|BG000|Baseline|Urodynamics With AC and WP|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WP & AC measurements"
11274890|NCT02756182|FG000|Participant Flow|Urodynamics With Air-Charged and Water Perfused|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure Water Perfused (WP) & Air-Charged (AC) measurements"
11274891|NCT02756182|OG000|Outcome|Urodynamics With AFC|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements"
11274892|NCT02756182|OG001|Outcome|Urodynamics With WFC|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements"
11286881|NCT02895100|EG003|Reported Event|Placebo Group|"Placebo control~Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period."
11274893|NCT02756182|OG001|Outcome|Urodynamics With WFC|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~Urodynamic study utilizing a single catheter technique to measure WFC measurements"
11274894|NCT02756182|EG000|Reported Event|Urodynamics With AC and WP|"Patients underwent a conventional urodynamics study utilizing a single catheter technique~TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WP & AC measurements"
11274895|NCT02756338|BG000|Baseline|BioMonitor 2 In-Office Setting Insertion Group|Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
11274896|NCT02756338|FG000|Participant Flow|BioMonitor 2 In-Office Setting Insertion Group|Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
11274897|NCT02756338|OG000|Outcome|BioMonitor 2 In-Office Setting Insertion Group|Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
11274898|NCT02756338|EG000|Reported Event|BioMonitor 2 In-Office Setting Insertion Group|Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
11286882|NCT02895295|BG000|Baseline|Control|Usual Care: Study subjects randomized to the control arm received access to information on resources available in the community to help them choose a prescription drug plan and on how to download their prescription drug information from their electronic medical record.
11286883|NCT02895295|BG001|Baseline|Expert Recommendation|"Study subjects randomized to the Expert Recommendation arm received access to a decision support tool that provided personalized, expert recommendations of particular plans as well as personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286884|NCT02895295|BG002|Baseline|Individual Analysis|"Study subjects randomized to the Individual Analysis arm received access to a decision support tool that provided personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286885|NCT02895295|BG003|Baseline|Total|Total of all reporting groups
11286886|NCT02895295|FG000|Participant Flow|Control|"Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan.~Usual Care: Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan."
11286887|NCT02895295|FG001|Participant Flow|Expert Recommendation|"Participants randomized to the Expert Recommendation arm will receive access to a decision support tool that provides personalized expert scores for particular plans based on individual's likely annual out-of-pocket spending, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of customer satisfaction).~Expert Recommendation: Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans."
11286888|NCT02895295|FG002|Participant Flow|Individual Analysis|"Participants randomized to Individual Analysis arm will receive will receive access to a decision support tool that provides individualized cost information for each plan but not the expert scores for particular plans.~Individual Analysis: Decision support tool that provides personalized information on the financial implications of enrolling in different plans."
11286889|NCT02895295|OG000|Outcome|Control|Usual Care: Study subjects randomized to the control arm received access to information on resources available in the community to help them choose a prescription drug plan and on how to download their prescription drug information from their electronic medical record.
11286890|NCT02895295|OG001|Outcome|Expert Recommendation|"Study subjects randomized to the Expert Recommendation arm received access to a decision support tool that provided personalized, expert recommendations of particular plans as well as personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286891|NCT02895295|OG002|Outcome|Individual Analysis|"Study subjects randomized to the Individual Analysis arm received access to a decision support tool that provided personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286892|NCT02895295|EG000|Reported Event|Control|Usual Care: Study subjects randomized to the control arm received access to information on resources available in the community to help them choose a prescription drug plan and on how to download their prescription drug information from their electronic medical record.
11286893|NCT02895295|EG001|Reported Event|Expert Recommendation|"Study subjects randomized to the Expert Recommendation arm received access to a decision support tool that provided personalized, expert recommendations of particular plans as well as personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286894|NCT02895295|EG002|Reported Event|Individual Analysis|"Study subjects randomized to the Individual Analysis arm received access to a decision support tool that provided personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction)."
11286895|NCT02895347|BG000|Baseline|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
11274899|NCT02756351|BG000|Baseline|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
11274900|NCT02756351|BG001|Baseline|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
11274901|NCT02756351|BG002|Baseline|Total|Total of all reporting groups
11274902|NCT02756351|FG000|Participant Flow|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
11274903|NCT02756351|FG001|Participant Flow|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
11274904|NCT02756351|OG000|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
11274905|NCT02756351|OG001|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
11274906|NCT02756351|EG000|Reported Event|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
11274907|NCT02756351|EG001|Reported Event|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
11274908|NCT02756364|BG000|Baseline|Arm A: Fulvestrant 500 mg|Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
11274909|NCT02756364|BG001|Baseline|Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
11274910|NCT02756364|BG002|Baseline|Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
11274911|NCT02756364|BG003|Baseline|Total|Total of all reporting groups
11274912|NCT02756364|FG000|Participant Flow|Arm A: Fulvestrant 500 mg|Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
11274913|NCT02756364|FG001|Participant Flow|Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
11274914|NCT02756364|FG002|Participant Flow|Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
11274915|NCT02756364|OG000|Outcome|Arm A: Fulvestrant 500 mg|Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
11274916|NCT02756364|OG001|Outcome|Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
11274917|NCT02756364|OG002|Outcome|Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
11274918|NCT02756364|EG000|Reported Event|Arm A: Fulvestrant 500 mg|Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).
11274919|NCT02756364|EG001|Reported Event|Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).
11274920|NCT02756364|EG002|Reported Event|Arm C: Fulvestrant 500 mg + Sapanisertib 30 mg QW|Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with sapanisertib 30 mg, capsule, orally, once weekly in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 17.0 weeks for fulvestrant and sapanisertib, each).
11274921|NCT02756572|BG000|Baseline|Treatment (Chemotherapy, HCT)|All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
11274922|NCT02756572|FG000|Participant Flow|Treatment (Chemotherapy, HCT)|All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
11274923|NCT02756572|OG000|Outcome|Treatment (Chemotherapy, HCT)|All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
11274924|NCT02756572|OG000|Outcome|Received Early Allogeneic HCT on Study|Patients who received an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
11274925|NCT02756572|OG000|Outcome|Received Allogeneic HCT on Study|Patients who received an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
11274926|NCT02756572|OG000|Outcome|Did Not Receive Allogeneic HCT on Study|Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
11274927|NCT02756572|OG001|Outcome|Did Not Receive Allogeneic HCT on Study|Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
11274928|NCT02756572|EG000|Reported Event|Post-Chemotherapy|All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine).
11274929|NCT02756572|EG001|Reported Event|Post-Transplant|Allogeneic peripheral blood stem cell transplant with reduced-intensity conditioning regimen consisted of fludarabine and melphalan, with total body irradiation for subjects over age 55. Prophylaxis for acute graft-vs-host-disease was mycophenylate mofetil (MMF), cyclosporine, and sirolimus.
11274930|NCT02756624|BG000|Baseline|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
11274931|NCT02756624|BG001|Baseline|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
11274932|NCT02756624|BG002|Baseline|Total|Total of all reporting groups
11274933|NCT02756624|FG000|Participant Flow|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
11274934|NCT02756624|FG001|Participant Flow|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
11274935|NCT02756624|OG000|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
11274936|NCT02756624|OG001|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
11274937|NCT02756624|EG000|Reported Event|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 0.24%"
11274938|NCT02756624|EG001|Reported Event|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks~AC-170 Vehicle"
11274939|NCT02756637|BG000|Baseline|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
11274940|NCT02756637|BG001|Baseline|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
11274941|NCT02756637|BG002|Baseline|Total|Total of all reporting groups
11274942|NCT02756637|FG000|Participant Flow|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
11274943|NCT02756637|FG001|Participant Flow|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
11274944|NCT02756637|OG000|Outcome|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
11274945|NCT02756637|OG001|Outcome|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
11274946|NCT02756637|EG000|Reported Event|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
11274947|NCT02756637|EG001|Reported Event|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
11274948|NCT02756650|BG000|Baseline|ACZ885N|Canakinumab
11274949|NCT02756650|FG000|Participant Flow|ACZ885N|Canakinumab
11274950|NCT02756650|OG000|Outcome|ACZ885N|Canakinumab
11274951|NCT02756650|EG000|Reported Event|ACZ885N|Canakinumab
11274952|NCT02756689|BG000|Baseline|Inpatient Group|"Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.~Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting."
11274953|NCT02756689|BG001|Baseline|Outpatient Group (Intervention)|"Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.~Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor."
11274954|NCT02756689|BG002|Baseline|Total|Total of all reporting groups
11274955|NCT02756689|FG000|Participant Flow|Inpatient Group|"Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.~Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting."
11274956|NCT02756689|FG001|Participant Flow|Outpatient Group (Intervention)|"Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.~Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor."
11274957|NCT02756689|OG000|Outcome|Inpatient Group|"Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.~Inpatient cervical ripening: Subjects will undergo cervical ripening in the inpatient setting."
11274958|NCT02756689|OG001|Outcome|Outpatient Group (Intervention)|"Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.~Outpatient cervical ripening: Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor."
11274959|NCT02756689|OG000|Outcome|Outpatient Group|Six Simple Questions: I had appropriate consideration for my time.
11274960|NCT02756689|OG001|Outcome|Inpatient Group|Six Simple Questions: I had appropriate and adequate control over my care.
11274961|NCT02756689|OG000|Outcome|Inpatient Group|Six Simple Questions Survey: The persons responsible for my care are/were caring and compassionate.
11274962|NCT02756689|OG001|Outcome|Outpatient Group|Six Simple Questions: The persons responsible for my care are/were caring and compassionate.
11274963|NCT02756689|OG000|Outcome|Inpatient Group|Six Simple Questions Survey: Problems that have arisen up to now have not been dealt with effectively.
11274964|NCT02756689|OG001|Outcome|Outpatient Group|Six Simple Questions Survey: Problems that have arisen up to now have not been dealt with effectively.
11274965|NCT02756689|OG000|Outcome|Inpatient Group|Six Simple Questions Survey: My needs have been addressed with appropriate consideration for my time.
11274966|NCT02756689|OG001|Outcome|Outpatient Group|Six Simple Questions Survey: My needs have been addressed with appropriate consideration for my time.
11274967|NCT02756689|OG000|Outcome|Inpatient Group|Six Simple Questions Survey: The overall organization of my care has not been appropriate.
11274968|NCT02756689|OG001|Outcome|Outpatient Group|Six Simple Questions Survey: The overall organization of my care has not been appropriate.
11274969|NCT02756689|OG000|Outcome|Inpatient Group|Six Simple Questions Survey: I would choose the same type of care for my next pregnancy.
11274970|NCT02756689|OG001|Outcome|Outpatient Group|Six Simple Questions Survey: I would choose the same type of care for my next pregnancy.
11274971|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X Survey: Presence of expert healthcare professionals during my childbirth.
11274972|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X Survey: Presence of expert healthcare professionals during my childbirth.
11274973|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X Survey: Information given by the healthcare professionals during childbirth.
11274974|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X Survey: Information given by the healthcare professionals during childbirth.
11274975|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X Survey: Taking your wishes seriously during childbirth.
11274976|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X Survey: Taking your wishes seriously during childbirth.
11274977|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X Survey: Emotional support by healthcare professionals during childbirth.
11274978|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X Survey: Emotional support by healthcare professionals during childbirth.
11274979|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X Survey: Feeling of security during childbirth.
11274980|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X Survey: Feeling of security during childbirth.
11274981|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X: Worries about the health of your child during childbirth.
11274982|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X: Worries about the health of your child during childbirth.
11274983|NCT02756689|OG000|Outcome|Inpatient Group|Lady-X: Time until the first contact with your child.
11274984|NCT02756689|OG001|Outcome|Outpatient Group|Lady-X: Time until the first contact with your child.
11274985|NCT02756689|OG000|Outcome|Inpatient Group|Labor pain scale: Worst amount of pain that you experienced during labor.
11274986|NCT02756689|OG001|Outcome|Outpatient Group|Labor pain scale: Worst amount of pain that you experienced during labor.
11274987|NCT02756689|OG000|Outcome|Inpatient Group|Labor pain scale: Overall pain that you experienced during labor.
11274988|NCT02756689|OG001|Outcome|Outpatient Group|Labor pain scale: Overall pain that you experienced during labor.
11274989|NCT02756689|OG000|Outcome|Inpatient Group|Labor pain scale: Worst amount of pain you experienced during placement of the Foley balloon.
11274990|NCT02756689|OG001|Outcome|Outpatient Group|Labor pain scale: Worst amount of pain you experienced during placement of the Foley balloon.
11274991|NCT02756689|OG000|Outcome|Inpatient Group|Labor pain scale: How likely are you to recommend your method of induction to a friend or family member?
11274992|NCT02756689|OG001|Outcome|Outpatient Group|Labor pain scale: How likely are you to recommend your method of induction to a friend or family member?
11274993|NCT02756689|EG000|Reported Event|Inpatient Group|Adverse Events: none
11274994|NCT02756689|EG001|Reported Event|Outpatient Group|Adverse events: none
11274995|NCT02756819|BG000|Baseline|Azilsartan Medoxomil|Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months.
11274996|NCT02756819|FG000|Participant Flow|Azilsartan Medoxomil|Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months.
11274997|NCT02756819|OG000|Outcome|Azilsartan Medoxomil|Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months.
11274998|NCT02756819|EG000|Reported Event|Azilsartan Medoxomil|Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months.
11274999|NCT02756832|BG000|Baseline|Alogliptin Benzoate|Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
11275000|NCT02756832|FG000|Participant Flow|Alogliptin Benzoate|Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
11275001|NCT02756832|OG000|Outcome|Alogliptin Benzoate|Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
11275002|NCT02756832|EG000|Reported Event|Alogliptin Benzoate|Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
11275003|NCT02756910|BG000|Baseline|Surgery Patients >1.5 Hrs|"Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring~iThermonitor (WT701): Continuously monitor the axillary temperature during surgery"
11275004|NCT02756910|FG000|Participant Flow|Surgery Patients >1.5 Hrs|"Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring~iThermonitor (WT701): Continuously monitor the axillary temperature during surgery"
11275005|NCT02756910|OG000|Outcome|Surgery Patients >1.5 Hrs|"Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring~iThermonitor (WT701): Continuously monitor the axillary temperature during surgery"
11275006|NCT02756910|EG000|Reported Event|Surgery Patients >1.5 Hrs|"Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring~iThermonitor (WT701): Continuously monitor the axillary temperature during surgery"
11275007|NCT02756949|BG000|Baseline|Smartphone-enabled App for Linkage to Care|"Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.~Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.~Smartphone"
11275008|NCT02756949|BG001|Baseline|Standard of Care|Participants in this arm are randomised to receive standard of care services.
11275009|NCT02756949|BG002|Baseline|Total|Total of all reporting groups
11275010|NCT02756949|FG000|Participant Flow|Smartphone-enabled App for Linkage to Care|"Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.~Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.~Smartphone"
11275011|NCT02756949|FG001|Participant Flow|Standard of Care|Participants in this arm are randomised to receive standard of care services.
11275012|NCT02756949|OG000|Outcome|Smartphone-enabled App for Linkage to Care|"Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.~Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.~Smartphone"
11275013|NCT02756949|OG001|Outcome|Standard of Care|Participants in this arm are randomised to receive standard of care services.
11275014|NCT02756949|EG000|Reported Event|Smartphone-enabled App for Linkage to Care|"Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.~Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.~Smartphone"
11275015|NCT02756949|EG001|Reported Event|Standard of Care|Participants in this arm are randomised to receive standard of care services.
11275016|NCT02757092|BG000|Baseline|Pulmonary Rehabilitation Group|arm group accept the pulmonary rehabilitation( smoking cession before operation, breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks.
11275017|NCT02757092|BG001|Baseline|The Control Group|The control group received pain medication and usual care.
11275018|NCT02757092|BG002|Baseline|Total|Total of all reporting groups
11275019|NCT02757092|FG000|Participant Flow|Home Pulmonary Rehabilitation Group|"Pulmonary Rehabilitation group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks.~study group : received pain medication and standard care"
11275020|NCT02757092|FG001|Participant Flow|Study Group|study group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day ,after discharged received standard care
11275021|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at discharge 2 weeks after discharge
11275022|NCT02757092|OG001|Outcome|The Control Group 2weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at discharge 2 weeks after discharge
11275023|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 Weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at 6 weeks after discharge
11275024|NCT02757092|OG001|Outcome|The Control Group 6 Weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at discharge6 weeks, after discharge
11275025|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation group12 Weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at discharge 12 weeks after discharge
11275026|NCT02757092|OG001|Outcome|The Control Group 12 Weeks Six-min Walking Distanc|Each subject received six-min walking distance assessments at discharge 12 weeks after discharge
11275027|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 Weeks FVC (Liter(L)/Sec)|Each subject received FVC assessments at 2 weeks after discharge
11275028|NCT02757092|OG001|Outcome|The Control Group 2 Weeks FVC(Liter(L)/Sec))|Each subject received FVC assessments at 2 weeks discharge
11275029|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 Weeks FEV1 (Liter(L)/Sec)|Each subject received FEV1 (liter(L)/sec)assessments at 2 weeks after discharge
11275030|NCT02757092|OG001|Outcome|The Control Group 2 Weeks FEV1(Liter(L)/Sec)|Each subject received FEV1(liter(L)/sec) assessments at 2 weeks after discharge
11275031|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received MMEF25-75%(liter(L)/sec) assessments at 2 weeks after discharge
11275032|NCT02757092|OG001|Outcome|The Control Group|Each subject received MMEF25-75%(liter(L)/sec) assessments at 2 weeks after discharge
11275033|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received PEFR assessments at 2 weeks after discharge
11275034|NCT02757092|OG001|Outcome|The Control Group|Each subject received PEFR assessments at 2 weeks after discharge
11275035|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 Weeks MIP(cmH2O)|Each subject received MIP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275036|NCT02757092|OG001|Outcome|The Control Group 2weeks MIP (cmH2O)|Each subject received MIP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275037|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 Weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275038|NCT02757092|OG001|Outcome|The Control Group 2weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275039|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 2 weeksModified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275040|NCT02757092|OG001|Outcome|The Control Group 2weeks Modified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275041|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow Triflo on discharge 2 weeks
11275042|NCT02757092|OG001|Outcome|Control Group|control group follow Triflo on discharge 2 weeks
11275043|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow CXR on discharge 2 weeks
11275044|NCT02757092|OG001|Outcome|Control Group|control group follow CXR on discharge 2 weeks
11275045|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 Weeks FVC(Liter(L)/Sec)|Each subject received (FVC in liter(L)/sec) assessments at 6 weeks after discharge
11275046|NCT02757092|OG001|Outcome|The Control Group 6 Weeks FVC (Liter(L)/Sec)|Each subject received FVC assessments at 6 weeks after discharge
11275047|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 Weeks FEV1,Liter(L)/Sec|Each subject received FEV1 assessments at discharge 6 weeks after discharge
11275048|NCT02757092|OG001|Outcome|The Control Group 6 Weeks FEV1,Liter(L)/Sec|Each subject received FEV1 assessments at discharge 6 weeks after discharge
11275049|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 Weeks MMEF(Liter(L)/Sec)|Each subject received MMEF assessments at 6 weeks after discharge
11275050|NCT02757092|OG001|Outcome|The Control Group 6 Weeks MMEF(Liter(L)/Sec)|Each subject received MMEF assessments at 6 weeks after discharge
11275051|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received PEFRassessments at 6 week after discharge
11275052|NCT02757092|OG001|Outcome|The Control Group|Each subject received PEFR assessments at 6 weeks after discharge
11275053|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group MIP(cmH2O)|Each subject received MIP assessments at discharge 6 weeks
11275054|NCT02757092|OG001|Outcome|The Control Group MIP(cmH2O)|Each subject received MIP assessments at discharge 6 weeks
11275055|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 Weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275056|NCT02757092|OG001|Outcome|The Control Group 6 Weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275057|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 6 weeksModified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275058|NCT02757092|OG001|Outcome|The Control Group 6 Weeks Modified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275059|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge 6 weeks
11275060|NCT02757092|OG001|Outcome|Control Group|control group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge 6 weeks
11275061|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow CXR on discharge 6 weeks
11275062|NCT02757092|OG001|Outcome|Control Group|control group follow CXR on discharge 6 weeks
11275063|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received FVC(L/sec) assessments at 12 weeks after discharge
11275064|NCT02757092|OG001|Outcome|The Control Group|Each subject received FVC(L/sec) assessments at 12 weeks after discharge
11275065|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 12 Weeks FEV1,Liter(L)/Sec|Each subject received FEV1 assessments at discharge12 weeks after discharge
11275066|NCT02757092|OG001|Outcome|The Control Group 12 Weeks FEV1,Liter(L)/Sec|Each subject received FEV1 assessments at discharge12 weeks after discharge
11275067|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 12weeks MMEF(Liter(L)/Sec)|Each subject received MMEF assessments at 12 weeks after discharge
11275068|NCT02757092|OG001|Outcome|The Control Group 12 Weeks MMEF(Liter(L)/Sec)|Each subject received MMEF assessments at 12 weeks after discharge
11275069|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received PEFR assessments at 12 weeks after discharge
11275070|NCT02757092|OG001|Outcome|The Control Group|Each subject received PEFR assessments at 12 weeks after discharge
11275071|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group|Each subject received MIP assessments at discharge 12 weeks
11275072|NCT02757092|OG001|Outcome|The Control Group(MIP,cmH2O)|Each subject received MIP assessments at discharge 12 weeks
11275073|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 12 Weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275074|NCT02757092|OG001|Outcome|The Control Group 12 Weeks MEP(cmH2O)|Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275075|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation Group 12weeksModified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275076|NCT02757092|OG001|Outcome|The Control Group 12 Weeks Modified Borg Score|Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
11275077|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge12 weeks
11275078|NCT02757092|OG001|Outcome|Control Group|control group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge12 weeks
11275079|NCT02757092|OG000|Outcome|Pulmonary Rehabilitation|study group follow CXR on discharge12 weeks
11275080|NCT02757092|OG001|Outcome|Control Group|control group follow CXR on discharge 12 weeks
11275081|NCT02757092|EG000|Reported Event|Pulmonary Rehabilitation Group|"0-2 weeks, the aerobic exercise intensity was targeted to reach 10-11 points of RPE scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day.Triflo-II was performed 8-10 times per hour. inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.~3-6 weeks, the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min).Triflo-II was performed 8-10 times per hour, and inspiratory muscle training, with the pressure intensity adjusted to more than 5% of that in the first stage."
11275082|NCT02757092|EG001|Reported Event|The Control Group|The control group accept the pulmonary rehabilitation , breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation.
11275083|NCT02757105|BG000|Baseline|RHB-102|1 tablet containing 3 mg immediate release and 9 mg sustained release ondansetron, once daily for 8 weeks
11275084|NCT02757105|BG001|Baseline|Placebo|1 tablet of matching placebo, once daily for 8 weeks
11275085|NCT02757105|BG002|Baseline|Total|Total of all reporting groups
11275086|NCT02757105|FG000|Participant Flow|RHB-102|1 tablet containing 3 mg immediate release and 9 mg sustained release ondansetron, once daily for 8 weeks
11275087|NCT02757105|FG001|Participant Flow|Placebo|1 tablet of matching placebo, once daily for 8 weeks
11275088|NCT02757105|OG000|Outcome|RHB-102|1 tablet containing 3 mg immediate release and 9 mg sustained release ondansetron, once daily for 8 weeks
11275089|NCT02757105|OG001|Outcome|Placebo|1 tablet of matching placebo, once daily for 8 weeks
11275090|NCT02757105|OG001|Outcome|Placebo|1 tablet matching placebo, once daily for 8 weeks
11275091|NCT02757105|EG000|Reported Event|RHB-102|1 tablet containing 3 mg immediate release and 9 mg sustained release ondansetron, once daily for 8 weeks
11275092|NCT02757105|EG001|Reported Event|Placebo|1 tablet matching placebo, once daily for 8 weeks
11275093|NCT02757326|BG000|Baseline|Phase 1b - 250 mg BID|For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
11275094|NCT02757326|BG001|Baseline|Phase 1b - 500 mg BID|For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
11275095|NCT02757326|BG002|Baseline|Phase 1b - 750 mg BID|For Phase 1b, ABC294640 was dosed at 750 mg BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
11275096|NCT02757326|BG003|Baseline|Total|Total of all reporting groups
11275097|NCT02757326|FG000|Participant Flow|250 mg|Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640 (Opaganib). Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 250 mg twice a day (bis in die). A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.
11275098|NCT02757326|FG001|Participant Flow|500 mg|Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 500 mg twice a day). A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.
11275099|NCT02757326|FG002|Participant Flow|750 mg|Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 doses at 750 mg twice a day ). A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.
11275100|NCT02757326|OG000|Outcome|Opaganib|Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 250, 500 and 750 mg twice a day. A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.
11275101|NCT02757326|OG000|Outcome|ABC294640 250 mg BID|ABC294640 250 mg BID given continuously
11275102|NCT02757326|OG001|Outcome|ABC294640 500 mg BID|ABC294640 250 mg BID given continuously
11275103|NCT02757326|OG002|Outcome|ABC294640 750 mg BID|ABC294640 750 mg BID given continuously
11275104|NCT02757326|OG000|Outcome|ABC294640 250 mg BID|Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
11275105|NCT02757326|OG001|Outcome|ABC294640 500 mg BID|Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
11275106|NCT02757326|OG002|Outcome|ABC294640 750 mg BID|Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
11275107|NCT02757326|EG000|Reported Event|250 mg Phase 1b|For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
11275108|NCT02757326|EG001|Reported Event|500 mg Phase 1b|For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
11275109|NCT02757326|EG002|Reported Event|750 mg Phase 1b|For Phase 1b, ABC294640 was dosed at 750 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
11275110|NCT02757352|BG000|Baseline|Placebo|Participants received placebo as 2 SC injections Q2W to week 52.
11275111|NCT02757352|BG001|Baseline|Ixekizumab 80 mg Q4W|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
11275112|NCT02757352|BG002|Baseline|Ixekizumab 80 mg Q2W|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
11275113|NCT02757352|BG003|Baseline|Total|Total of all reporting groups
11275114|NCT02757352|FG000|Participant Flow|Placebo Double-Blind Period|Participants received placebo (PBO) as 2 subcutaneous (SC) injections every two weeks (Q2W) to week 52.
11275115|NCT02757352|FG001|Participant Flow|Ixekizumab 80 mg Q4W (IxeQ4W) Double-Blind Period|Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
11275116|NCT02757352|FG002|Participant Flow|Ixekizumab 80 mg Q2W (IxeQ2W) Double-Blind Period|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC (Q2W) to week 52.
11275117|NCT02757352|FG003|Participant Flow|PBO IR/Ixe80Q2W-Open Label|Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
11275118|NCT02757352|FG004|Participant Flow|Ixekizumab 80 mg Q4W IR (Ixe80Q4WIR)/Ixe80Q2W-Open Label|Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
11275119|NCT02757352|FG005|Participant Flow|Ixekizumab 80 mg Q2W IR (Ixe80Q2WIR)/Ixe80Q2W-Open Label|Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label.
11275120|NCT02757352|FG006|Participant Flow|Placebo Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
11275121|NCT02757352|FG007|Participant Flow|Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
11275122|NCT02757352|FG008|Participant Flow|Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period
11275123|NCT02757352|FG009|Participant Flow|Other Biologic Treatment Group|Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
11275124|NCT02757352|OG000|Outcome|Placebo|Participants received placebo as 2 SC injections Q2W to week 52.
11275125|NCT02757352|OG001|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
11275126|NCT02757352|OG002|Outcome|Ixekizumab 80 mg Q2W|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
11275127|NCT02757352|OG000|Outcome|Placebo|Participants received placebo as 2 SC injections Q2W to week 52..
11275128|NCT02757352|OG001|Outcome|Ixekizumab 80 mg Q4W|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 and placebo followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
10970274|NCT00909779|OG001|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
11275129|NCT02757352|OG000|Outcome|Ixe80Q2W-Q2W|Participants received a starting dose of 80 ixekizumab as an SC injection at week 0 followed by 80 mg of ixe every two weeks (Q2W) week 2 to week 52.
11275130|NCT02757352|OG001|Outcome|Ixe80Q4W-Q4W|Participants received a starting dose of 80 ixekizumab as an SC injection followed by 80 mg of ixekizumab Q4W week 4 to week 52.
11275131|NCT02757352|OG002|Outcome|PBO-Ixe80Q2W|Participants who received placebo in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open-label.
11275132|NCT02757352|OG003|Outcome|Ixe80Q4W-Q2W|Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open label.
11275133|NCT02757352|OG000|Outcome|IxeQ2W (80S)/IxeQ2W|Ixekizumab was administered subcutaneously every 2 weeks with an 80 mg starting dose at week 0.
11275134|NCT02757352|OG001|Outcome|IxeQ2W (80S)/IxeQ2W Open Label|Ixekizumab was administered every 2 weeks with an 80 mg starting dose at Week 0, then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
11275135|NCT02757352|OG002|Outcome|IxeQ2W (160S)/IxeQ2W|Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0.
11275136|NCT02757352|OG003|Outcome|IxeQ2W (160s)/IxeQ2W Open Label|Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
11275137|NCT02757352|OG004|Outcome|IxeQ4W (80S) IxeQ4W|Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0.
11275138|NCT02757352|OG005|Outcome|IxeQ4W (80S)/IxeQ2W Open Label|Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
11275139|NCT02757352|OG006|Outcome|IxeQ4W(160S)/IxeQ4W|Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0.
10970275|NCT00909779|EG000|Reported Event|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
10970276|NCT00909779|EG001|Reported Event|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
10970277|NCT00909792|BG000|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
11275140|NCT02757352|OG007|Outcome|IxeQ4W (160S) IxeQ2W Open Label|Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
11275141|NCT02757352|OG008|Outcome|PBO/IxeQ2W Open Label|Placebo was administered at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
11275142|NCT02757352|EG000|Reported Event|Placebo Double-Blind Period|Participants received placebo as 2 SC injections Q2W to week 52.
11275143|NCT02757352|EG001|Reported Event|Ixekizumab 80 mg Q4W Double-Blind Period|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
11275144|NCT02757352|EG002|Reported Event|Ixekizumab 80 mg Q2W Double-Blind Period|Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
11275145|NCT02757352|EG003|Reported Event|PBO IR/IxeQ2W Open Label|Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
11275146|NCT02757352|EG004|Reported Event|Ixe80Q4WIR/Ixe80Q2W Open Label|Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
11275147|NCT02757352|EG005|Reported Event|Ixe80Q2WIR/Ixe80Q2W Open Label|Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label.
11275148|NCT02757352|EG006|Reported Event|Other Biologic Open Label|Participants who discontinued study treatment and were on other biologic therapy prior to entering Follow-up period
11275149|NCT02757352|EG007|Reported Event|Placebo Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
11275150|NCT02757352|EG008|Reported Event|Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
11275151|NCT02757352|EG009|Reported Event|Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period|Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
11275152|NCT02757352|EG010|Reported Event|Other Biologic Post Treatment Follow-Up Period|Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
11275153|NCT02757430|BG000|Baseline|Subjects With EnSite Precision™ Cardiac Mapping|Any patient indicated to undergo a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible. Subjects meeting all inclusion criteria and not meeting any exclusion criteria were enrolled in the study.
11275154|NCT02757430|FG000|Participant Flow|Subjects With EnSite Precision™ Cardiac Mapping|Any patient indicated to undergo a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible. Subjects meeting all inclusion criteria and not meeting any exclusion criteria were enrolled in the study.
10970278|NCT00909792|FG000|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
10970279|NCT00909792|FG001|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
10970280|NCT00909792|OG000|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10970281|NCT00909792|OG001|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
10970282|NCT00909792|EG000|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
10970283|NCT00909792|EG001|Reported Event|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
10970284|NCT00909844|BG000|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
10970285|NCT00909844|FG000|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
10970286|NCT00909844|OG000|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
11275155|NCT02757430|OG000|Outcome|Subjects With EnSite Precision™ Cardiac Mapping|Any patient indicated to undergo a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible. Subjects meeting all inclusion criteria and not meeting any exclusion criteria were enrolled in the study.
11275156|NCT02757430|OG000|Outcome|All Maps|All maps created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
11275157|NCT02757430|OG000|Outcome|All Manual Maps|All manual maps created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
10970287|NCT00909844|OG000|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
11275158|NCT02757430|OG000|Outcome|All AutoMap Module Maps|All AutoMap module maps created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
11275159|NCT02757430|OG000|Outcome|All TurboMap Module Maps|All TurboMap module maps created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
10970288|NCT00909844|EG000|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
10970289|NCT00909857|BG000|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
10970290|NCT00909857|BG001|Baseline|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
10970291|NCT00909857|BG002|Baseline|Total|Total of all reporting groups
10970292|NCT00909857|FG000|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
10970293|NCT00909857|FG001|Participant Flow|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
10970294|NCT00909857|OG000|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
10970295|NCT00909857|OG001|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
10970296|NCT00909857|EG000|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
10970297|NCT00909857|EG001|Reported Event|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
10970298|NCT00909870|BG000|Baseline|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
10970299|NCT00909870|BG001|Baseline|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
10970300|NCT00909870|BG002|Baseline|Total|Total of all reporting groups
10970301|NCT00909870|FG000|Participant Flow|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
10970302|NCT00909870|FG001|Participant Flow|Active Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
10970303|NCT00909870|OG000|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
10970304|NCT00909870|OG001|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
10970305|NCT00909870|OG000|Outcome|Investigational Treatment (Dermagraft Plus Standard-of=- Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
10970306|NCT00909870|EG000|Reported Event|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
11092303|NCT01539070|EG001|Reported Event|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
11275160|NCT02757430|OG000|Outcome|All Maps With Mapping Points Collected|All maps with number of mapping points collected available created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
11275161|NCT02757430|OG000|Outcome|All Maps With Mapping Points Used|All maps with number of mapping points used available created in patients enrolled in the study and who underwent a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System.
11275162|NCT02757430|OG000|Outcome|Procedures With Unstable Maps|System stability throughout the procedure was assessed. System was not stable throughout the procedure in 46 procedures.
11275163|NCT02757430|OG000|Outcome|All Subjects With Identified Gaps in Lesion Line|All subjects with ablation procedure performed and gap identified in lesion line.
11275164|NCT02757430|OG000|Outcome|Procedures With AutoMark Feature Used|All procedures in which the EnSite(TM) AutoMark feature was used
11275165|NCT02757430|EG000|Reported Event|Subjects With EnSite Precision™ Cardiac Mapping|Any patient indicated to undergo a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible. Subjects meeting all inclusion criteria and not meeting any exclusion criteria were enrolled in the study.
11275166|NCT02757625|BG000|Baseline|Dexmedetomidine: >=45 Weeks CGA to <12 Months|Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275167|NCT02757625|BG001|Baseline|Dexmedetomidine: >=12 Months to <24 Months|Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275168|NCT02757625|BG002|Baseline|Dexmedetomidine: >=2 Years to <6 Years|Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275169|NCT02757625|BG003|Baseline|Dexmedetomidine: >=6 Years to <17 Years|Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275170|NCT02757625|BG004|Baseline|Total|Total of all reporting groups
11275171|NCT02757625|FG000|Participant Flow|Dexmedetomidine: >=45 Weeks CGA to <12 Months|Participants with age between >=45 weeks corrected gestation age (CGA) to <12 months received 0.2 microgram per kilogram per hour (mcg/kg/h) of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275172|NCT02757625|FG001|Participant Flow|Dexmedetomidine: >=12 Months to <24 Months|Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275173|NCT02757625|FG002|Participant Flow|Dexmedetomidine: >=2 Years to <6 Years|Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275174|NCT02757625|FG003|Participant Flow|Dexmedetomidine: >=6 Years to <17 Years|Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275175|NCT02757625|OG000|Outcome|Dexmedetomidine: >=45 Weeks CGA to <12 Months|Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275176|NCT02757625|OG001|Outcome|Dexmedetomidine: >=12 Months to <24 Months|Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275177|NCT02757625|OG002|Outcome|Dexmedetomidine: >=2 Years to <6 Years|Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275178|NCT02757625|OG003|Outcome|Dexmedetomidine: >=6 Years to <17 Years|Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275179|NCT02757625|OG004|Outcome|Dexmedetomidine: All Participants|Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275180|NCT02757625|EG000|Reported Event|Dexmedetomidine: >=45 Weeks CGA to <12 Months|Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275181|NCT02757625|EG001|Reported Event|Dexmedetomidine: >=12 Months to <24 Months|Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275182|NCT02757625|EG002|Reported Event|Dexmedetomidine: >=2 Years to <6 Years|Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275183|NCT02757625|EG003|Reported Event|Dexmedetomidine: >=6 Years to <17 Years|Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275184|NCT02757625|EG004|Reported Event|Dexmedetomidine: All Participants|Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
11275185|NCT02757768|BG000|Baseline|Mirabegron|Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
11275186|NCT02757768|BG001|Baseline|Placebo|Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
11275187|NCT02757768|BG002|Baseline|Total|Total of all reporting groups
11275188|NCT02757768|FG000|Participant Flow|Mirabegron|Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
11275189|NCT02757768|FG001|Participant Flow|Placebo|Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
11275190|NCT02757768|OG000|Outcome|Mirabegron|Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
11275191|NCT02757768|OG001|Outcome|Placebo|Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
11275192|NCT02757768|OG000|Outcome|Mirabegron|Participants received mirabegron at an initial dose of 25 mg, mirabegron was increased to 50 mg after 4 weeks. Participants continued once daily treatment with tamsulosin hydrochloride 0.4 mg throughout the study.
11275193|NCT02757768|OG001|Outcome|Placebo|Participants received placebo to match mirabegron at an initial dose of 25 mg, placebo to match mirabegron was increased to 50 mg after 4 weeks. Participants continued once daily treatment with tamsulosin hydrochloride 0.4 mg throughout the study.
11275194|NCT02757768|EG000|Reported Event|Mirabegron|Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study.
11275195|NCT02757768|EG001|Reported Event|Placebo|Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
11275196|NCT02757950|BG000|Baseline|Exposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).
11275197|NCT02757950|BG001|Baseline|Unexposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.
11275198|NCT02757950|BG002|Baseline|Total|Total of all reporting groups
11275199|NCT02757950|FG000|Participant Flow|Exposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).
11275200|NCT02757950|FG001|Participant Flow|Unexposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.
11275201|NCT02757950|OG000|Outcome|Exposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).
11275202|NCT02757950|OG001|Outcome|Unexposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.
11275203|NCT02757950|OG000|Outcome|Unexposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.
11275204|NCT02757950|EG000|Reported Event|Unexposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.
11275205|NCT02757950|EG001|Reported Event|Exposed Cohort|Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).
11275206|NCT02757963|BG000|Baseline|IPSS >=8 or BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses (i.e. met entry criteria, including positive IPSS score >=8 and/or BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment). Participants with probable BPH (PSA>=2 ng/mL) proceeded to Part II and were scheduled for a urologist assessment which was to confirm or refute a diagnosis of BPH and to estimate whether the participant is at risk of progression of BPH.
11275207|NCT02757963|FG000|Participant Flow|IPSS >=8 or BPE/BPO >=3|Participants were screened using the Benign prostatic enlargement (BPE)/ benign prostatic obstruction (BPO) and International Prostate Symptom Score (IPSS) screening tools. Participants with positive responses (i.e. met entry criteria, including positive IPSS score >= 8 and/or BPE/BPO score >= 3) were enrolled and proceeded to Part I (GP Assessment). Participants with probable BPH [PSA>= 2 Nano gram per milliliter (ng/mL)] proceeded to Part II and were scheduled for a urologist assessment which was to confirm or refute a diagnosis of BPH and to estimate whether the participant is at risk of progression of BPH.
11275208|NCT02757963|OG000|Outcome|BPE/BPO >=3|Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score >= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275209|NCT02757963|OG000|Outcome|IPSS >=8|Participants were screened using the IPSS screening tool. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive IPSS score >=8) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH.
11275210|NCT02757963|OG001|Outcome|IPSS >=8 and BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >=8 and BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275211|NCT02757963|OG002|Outcome|IPSS >=8 or BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >=8 or BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275212|NCT02757963|OG000|Outcome|IPSS >=8|Participants were screened using the IPSS screening tool. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive IPSS score >= 8) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH.
11275213|NCT02757963|OG001|Outcome|BPE/BPO >=3|Participants were screened using BPE/BPO screening tool. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate risk of progression of BPH
11275214|NCT02757963|OG002|Outcome|IPSS >=8 and BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >= 8 and BPE/BPO score >= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275215|NCT02757963|OG003|Outcome|IPSS >=8 or BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >= 8 or BPE/BPO score >= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275216|NCT02757963|OG001|Outcome|BPE/BPO >=3|Participants were screened using BPE/BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate risk of progression of BPH
11275217|NCT02757963|OG002|Outcome|IPSS >=8 and BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >=8 and BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275218|NCT02757963|OG003|Outcome|IPSS >= 8 or BPE/BPO >=3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >=8 or BPE/BPO score >=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
11275219|NCT02757963|OG000|Outcome|All Screened Subjects|All the participants who signed informed consent form and were screened for eligibility were included in this arm
11275220|NCT02757963|EG000|Reported Event|IPSS >= 8 or BPE/BPO >= 3|Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score >= 8 or BPE/BPO score >= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA >= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
10847396|NCT00283062|FG003|Participant Flow|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
11275221|NCT02758119|BG000|Baseline|Serious Game|"Participants in the serious game group will be pre-trained before the hands-on sessions with the serious game Staying Alive, available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.~Serious Game"
11275222|NCT02758119|BG001|Baseline|Online Course|"Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.~Online course"
11275223|NCT02758119|BG002|Baseline|Total|Total of all reporting groups
11275224|NCT02758119|FG000|Participant Flow|Online Course|"Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.~Online course"
11275225|NCT02758119|FG001|Participant Flow|Serious Game|"Participants in the serious game group will be pre-trained before the hands-on sessions with the serious game Staying Alive, available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.~Serious Game"
11275226|NCT02758119|OG000|Outcome|Online Course|"Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.~Online course"
11275227|NCT02758119|OG001|Outcome|Serious Game|"Participants in the serious game group will be pre-trained before the hands-on sessions with the serious game Staying Alive, available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.~Serious Game"
11275228|NCT02758119|OG000|Outcome|Serious Game|"Participants in the serious game group will be pre-trained before the hands-on sessions with the serious game Staying Alive, available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.~Serious Game"
11275229|NCT02758119|OG001|Outcome|Online Course|"Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.~Online course"
11275230|NCT02758119|EG000|Reported Event|Online Course|"Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.~Online course"
10970307|NCT00909870|EG001|Reported Event|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
11275231|NCT02758119|EG001|Reported Event|Serious Game|"Participants in the serious game group will be pre-trained before the hands-on sessions with the serious game Staying Alive, available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.~Serious Game"
11275232|NCT02758171|BG000|Baseline|FDC/Empagliflozin+Linagliptin|"The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
11275233|NCT02758171|BG001|Baseline|Empagliflozin+Linagliptin/FDC|"The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
11275234|NCT02758171|BG002|Baseline|Total|Total of all reporting groups
11275235|NCT02758171|FG000|Participant Flow|FDC/Empagliflozin+Linagliptin|"The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
11275236|NCT02758171|FG001|Participant Flow|Empagliflozin+Linagliptin/FDC|"The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.~A wash-out period of at least 35 days was set following the drug administration in each period."
11275237|NCT02758171|OG000|Outcome|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
11275238|NCT02758171|OG001|Outcome|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
11275239|NCT02758171|EG000|Reported Event|FDC (10 mg Empagliflozin and 5 mg Linagliptin)|The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
11275240|NCT02758171|EG001|Reported Event|Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets|The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
11275241|NCT02758210|BG000|Baseline|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
11275242|NCT02758210|FG000|Participant Flow|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
10847397|NCT00283062|OG000|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11275243|NCT02758210|OG000|Outcome|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
11275244|NCT02758210|EG000|Reported Event|Participants With MICRA Device|Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit.
11275245|NCT02758301|BG000|Baseline|Reveal LINQ Cohort|Subjects inserted with a Reveal LINQ implantable cardiac monitor
11275246|NCT02758301|BG001|Baseline|Enrolled But Not Inserted Group|Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device, but had a Baseline Form Completed.
11275247|NCT02758301|BG002|Baseline|Total|Total of all reporting groups
11275248|NCT02758301|FG000|Participant Flow|Reveal LINQ Cohort|Subjects inserted with a Reveal LINQ implantable cardiac monitor
11275249|NCT02758301|FG001|Participant Flow|Enrolled But Not Inserted Group|Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
11275250|NCT02758301|OG000|Outcome|Reveal LINQ Cohort|Subjects inserted with a Reveal LINQ implantable cardiac monitor
11275251|NCT02758301|OG001|Outcome|Enrolled But Not Inserted Group|Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
11275252|NCT02758301|EG000|Reported Event|Reveal LINQ Cohort|Subjects inserted with a Reveal LINQ implantable cardiac monitor
11275253|NCT02758301|EG001|Reported Event|Enrolled But Not Inserted Group|Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device.
11275254|NCT02758613|BG000|Baseline|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275255|NCT02758613|BG001|Baseline|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275256|NCT02758613|BG002|Baseline|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275257|NCT02758613|BG003|Baseline|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275258|NCT02758613|BG004|Baseline|Total|Total of all reporting groups
11275259|NCT02758613|FG000|Participant Flow|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275260|NCT02758613|FG001|Participant Flow|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275261|NCT02758613|FG002|Participant Flow|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275262|NCT02758613|FG003|Participant Flow|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275263|NCT02758613|OG000|Outcome|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275264|NCT02758613|OG001|Outcome|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275265|NCT02758613|OG002|Outcome|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275266|NCT02758613|OG003|Outcome|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275267|NCT02758613|OG000|Outcome|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275268|NCT02758613|OG001|Outcome|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275269|NCT02758613|OG002|Outcome|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
11275270|NCT02758613|EG000|Reported Event|Placebo|Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275271|NCT02758613|EG001|Reported Event|2mg Baricitinib|2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275272|NCT02758613|EG002|Reported Event|4mg Baricitinib|4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275273|NCT02758613|EG003|Reported Event|10mg Baricitinib|10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
11275274|NCT02758899|BG000|Baseline|Diabetic Patients|Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275275|NCT02758899|BG001|Baseline|Control Patients|Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275276|NCT02758899|BG002|Baseline|Total|Total of all reporting groups
11275277|NCT02758899|FG000|Participant Flow|Diabetic Patients|Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275278|NCT02758899|FG001|Participant Flow|Control Patients|Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275279|NCT02758899|OG000|Outcome|Diabetic Patients|Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275280|NCT02758899|OG001|Outcome|Control Patients|Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275281|NCT02758899|EG000|Reported Event|Diabetic Patients|Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275282|NCT02758899|EG001|Reported Event|Control Patients|Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
11275283|NCT02759016|BG000|Baseline|Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275284|NCT02759016|BG001|Baseline|Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275285|NCT02759016|BG002|Baseline|Total|Total of all reporting groups
10847398|NCT00283062|OG001|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11275286|NCT02759016|FG000|Participant Flow|Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275287|NCT02759016|FG001|Participant Flow|Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275288|NCT02759016|OG000|Outcome|BI 836826 + Ibrutinib|"Treatment group BI 836826 + ibrutinib comprises all dose cohorts during the dose escalation phase, that is, Dose cohort BI 836826 100 mg + ibrutinib and Dose cohort BI 836826 200 mg + ibrutinib.~Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously in Cycle (=4 weeks) 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12."
11275289|NCT02759016|OG000|Outcome|Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275290|NCT02759016|OG001|Outcome|Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275291|NCT02759016|EG000|Reported Event|Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11286896|NCT02895347|BG001|Baseline|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
11286897|NCT02895347|BG002|Baseline|Total|Total of all reporting groups
10970308|NCT00910000|BG000|Baseline|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970309|NCT00910000|BG001|Baseline|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970310|NCT00910000|BG002|Baseline|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970311|NCT00910000|BG003|Baseline|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970312|NCT00910000|BG004|Baseline|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970313|NCT00910000|BG005|Baseline|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970314|NCT00910000|BG006|Baseline|Total|Total of all reporting groups
10970315|NCT00910000|FG000|Participant Flow|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970316|NCT00910000|FG001|Participant Flow|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970317|NCT00910000|FG002|Participant Flow|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970318|NCT00910000|FG003|Participant Flow|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970319|NCT00910000|FG004|Participant Flow|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970320|NCT00910000|FG005|Participant Flow|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970321|NCT00910000|OG000|Outcome|All Phase Ib Participants|"All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9).~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970322|NCT00910000|OG000|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970323|NCT00910000|OG001|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970324|NCT00910000|OG002|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970325|NCT00910000|OG003|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970326|NCT00910000|OG004|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
10970327|NCT00910000|OG005|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
11275292|NCT02759016|EG001|Reported Event|Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib|Participants underwent a 2-week run-in phase with ibrutinib prior to the start of BI 836826. In combination with ibrutinib (420 mg daily dose, orally administered) BI 836826 was administered intravenously as a rate controlled injection in 4-week cycles, every two weeks for the first 16 weeks (Cycles 1-4), and every 4 weeks starting at week 17 (Cycle 5) until week 48 (Cycle 12). BI 836826 was administered in Cycle 1 on day 1 (10 mg), days 2 and 8 (50% of the assigned dose on each day), day 15 (100% of the assigned dose), in Cycles 2-4 on days 1 and 15 of each cycle (100% of the assigned dose), in Cycles 5-12 on day 1 (100% of the assigned dose). Participants could have initiated 12 cycles with BI 836826 and could be treated with ibrutinib unless progression, unacceptable toxicity, or withdrawal of consent occurred earlier. Continued treatment beyond Cycle 12 (up to a maximum of 24 treatment cycles) was possible for participants with a pre-specified response status at end of Cycle 12.
11275293|NCT02759055|BG000|Baseline|Clinical Decision Support (Cardiovascular Wizard)|"In the Intervention arm, primary care providers will be provided with an Electronic Health Record-linked, Web-based clinical decision support system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based Clinical Decision Support and follow up to reduce risk of heart attacks or stroke, optimizing management and follow up of pre-diabetes patients with uncontrolled cardiovascular risk factors.~Clinical Decision Support: an Electronic Health Record-linked, Web-based clinical decision support (CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke"
11275294|NCT02759055|BG001|Baseline|Usual Care|In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
11275295|NCT02759055|BG002|Baseline|Total|Total of all reporting groups
11275296|NCT02759055|FG000|Participant Flow|Clinical Decision Support (CV Wizard)|"In the Intervention arm, primary care providers will be provided with an Electronic Health Record-linked, Web-based clinical decision support system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke, optimizing management and follow up of pre-diabetes patients with uncontrolled cardiovascular risk factors.~Clinical Decision Support: an Electronic Health Record(EHR)-linked, Web-based clinical decision support(CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke"
11275297|NCT02759055|FG001|Participant Flow|Usual Care|In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
11275298|NCT02759055|OG000|Outcome|Clinical Decision Support (CV Wizard)|"In the Intervention arm, primary care providers will be provided with an Electronic Health Record-linked, Web-based clinical decision support system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based Clinical Decision Support and follow up to reduce risk of heart attacks or stroke, optimizing management and follow up of pre-diabetes patients with uncontrolled cardiovascular risk factors.~Clinical Decision Support: an EHR-linked, Web-based clinical decision support (CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke"
11275299|NCT02759055|OG001|Outcome|Usual Care|In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
11275300|NCT02759055|EG000|Reported Event|Clinical Decision Support (Cardiovascular Wizard)|"In the Intervention arm, primary care providers will be provided with an EHR-linked, Web-based clinical decision support system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke, optimizing management and follow up of pre-diabetes patients with uncontrolled cardiovascular risk factors.~Clinical Decision Support: an EHR-linked, Web-based clinical decision support (CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke"
11275301|NCT02759055|EG001|Reported Event|Usual Care|In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
11275302|NCT02759120|BG000|Baseline|Antimicrobial Therapy Plus Standard of Care|"Co-trimoxazole OR doxycycline~Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months"
11275303|NCT02759120|BG001|Baseline|Standard of Care|"Standard of care for patients with IPF for comparison~No Intervention: Standard of Care: Standard of care"
11275304|NCT02759120|BG002|Baseline|Total|Total of all reporting groups
11275305|NCT02759120|FG000|Participant Flow|Antimicrobial Therapy Plus Standard of Care|"Co-trimoxazole OR doxycycline~Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months"
11275306|NCT02759120|FG001|Participant Flow|Standard of Care|"Standard of care for patients with IPF for comparison~No Intervention: Standard of Care: Standard of care"
11275307|NCT02759120|OG000|Outcome|Antimicrobial Therapy Plus Standard of Care|"Co-trimoxazole OR doxycycline~Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months"
11275308|NCT02759120|OG001|Outcome|Standard of Care|"Standard of care for patients with IPF for comparison~No Intervention: Standard of Care: Standard of care"
11275309|NCT02759120|EG000|Reported Event|Antimicrobial Therapy Plus Standard of Care|"Co-trimoxazole OR doxycycline~Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months"
11275310|NCT02759120|EG001|Reported Event|Standard of Care|"Standard of care for patients with IPF for comparison~No Intervention: Standard of Care: Standard of care"
11275311|NCT02759146|BG000|Baseline|Reflexology Patients|"Patients randomized into the reflexology arm, given reflexology from a friend/ family member.~Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms."
11275312|NCT02759146|BG001|Baseline|Meditative Practice Patients|"Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.~Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns"
11275313|NCT02759146|BG002|Baseline|Control Patients|Control- no intervention
11275314|NCT02759146|BG003|Baseline|Reflexology Caregivers|"Caregivers providing reflexology to their friend/ family member.~Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms."
11275315|NCT02759146|BG004|Baseline|Meditation Practice Caregivers|"Caregivers providing meditative practice to their friend/ family member.~Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns"
11275316|NCT02759146|BG005|Baseline|Control Caregivers|Control - no intervention
11275317|NCT02759146|BG006|Baseline|Total|Total of all reporting groups
11275318|NCT02759146|FG000|Participant Flow|Reflexology With Response, Then Continued Reflexology|"Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.~Participants were randomized into the reflexology intervention, then after week 4 of symptom responses, were considered responders. Participants then continued with the reflexology intervention."
11275319|NCT02759146|FG001|Participant Flow|Reflexology Non-responders, Then Continued Reflexology|"Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.~Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the reflexology intervention."
11275320|NCT02759146|FG002|Participant Flow|Reflexology Non-responders, Then Switch to Meditation|"Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.~Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.~Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a meditative practice intervention."
11275321|NCT02759146|FG003|Participant Flow|Control|Control - no intervention
10970328|NCT00910000|EG000|Reported Event|All Phase Ib Participants|All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9). Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
11275322|NCT02759146|FG004|Participant Flow|Meditative Practice With Response, Continued Meditation|"Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.~Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom response were considered responders. Participants then continued with the meditative practice intervention."
11275323|NCT02759146|FG005|Participant Flow|Meditative Practice Non-responders, Continued Meditation|"Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.~Participants were randomized into the mindfulness meditation intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the meditative practice intervention."
11275324|NCT02759146|FG006|Participant Flow|Meditative Practice Non-responders, Switch to Reflexology|"Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.~Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.~Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a reflexology intervention."
11275325|NCT02759146|OG000|Outcome|Reflexology Patients|"Patients randomized into the reflexology arm, given reflexology from a friend/ family member.~Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms."
11275326|NCT02759146|OG001|Outcome|Meditative Practice Patients|"Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.~Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns"
11275327|NCT02759146|OG002|Outcome|Control Patients|Control- no intervention
11275328|NCT02759146|OG000|Outcome|Reflexology|Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
11275329|NCT02759146|OG001|Outcome|Meditative Practice|Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
11275330|NCT02759146|OG002|Outcome|Control|Control - no intervention
11275331|NCT02759146|OG000|Outcome|Reflexology, Switching to Meditative Practices|Participants randomized into reflexology for weeks 1-4, then re-randomized to Meditative Practices for weeks 5-12
11275332|NCT02759146|OG001|Outcome|Reflexology, Continuing With Reflexology|Participants randomized into reflexology for weeks 1-4 and continuing with reflexology for weeks 5-12
11275333|NCT02759146|OG002|Outcome|Meditative Practice, Switching to Reflexology|Participants randomized to meditative practice for weeks 1-4, then re-randomized to reflexology for weeks 5-12
11275334|NCT02759146|OG003|Outcome|Meditative Practice, Continuing With Meditative Practice|Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
11275335|NCT02759146|OG001|Outcome|Meditative Practive Patients|"Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.~Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns"
11275336|NCT02759146|EG000|Reported Event|Reflexology|Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
11275337|NCT02759146|EG001|Reported Event|Meditative Practice|Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
11275338|NCT02759146|EG002|Reported Event|Control|Control - no intervention
11275339|NCT02759315|BG000|Baseline|GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275340|NCT02759315|BG001|Baseline|GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275341|NCT02759315|BG002|Baseline|GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275342|NCT02759315|BG003|Baseline|GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275343|NCT02759315|BG004|Baseline|GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275344|NCT02759315|BG005|Baseline|Total|Total of all reporting groups
11275345|NCT02759315|FG000|Participant Flow|GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275346|NCT02759315|FG001|Participant Flow|GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275347|NCT02759315|FG002|Participant Flow|GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275348|NCT02759315|FG003|Participant Flow|GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275349|NCT02759315|FG004|Participant Flow|GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275350|NCT02759315|OG000|Outcome|GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275351|NCT02759315|OG001|Outcome|GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275352|NCT02759315|OG002|Outcome|GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275353|NCT02759315|OG003|Outcome|GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275354|NCT02759315|OG004|Outcome|GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275355|NCT02759315|OG000|Outcome|GT1a: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1a infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275356|NCT02759315|OG005|Outcome|GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275357|NCT02759315|EG000|Reported Event|GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275358|NCT02759315|EG001|Reported Event|GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275359|NCT02759315|EG002|Reported Event|GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275360|NCT02759315|EG003|Reported Event|GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275361|NCT02759315|EG004|Reported Event|GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg|Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
11275362|NCT02759354|BG000|Baseline|Group Vaxelis (3+1)|Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275363|NCT02759354|BG001|Baseline|Group Infanrix Hexa (3+1)|Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275364|NCT02759354|BG002|Baseline|Group Vaxelis (2+1)|Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275365|NCT02759354|BG003|Baseline|Group Infanrix Hexa (2+1)|Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275366|NCT02759354|BG004|Baseline|Total|Total of all reporting groups
11275367|NCT02759354|FG000|Participant Flow|Group Vaxelis (3+1)|Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275368|NCT02759354|FG001|Participant Flow|Group Infanrix Hexa (3+1)|Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275369|NCT02759354|FG002|Participant Flow|Group Vaxelis (2+1)|Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275370|NCT02759354|FG003|Participant Flow|Group Infanrix Hexa (2+1)|Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275371|NCT02759354|OG000|Outcome|Group Vaxelis (3+1)|Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275372|NCT02759354|OG001|Outcome|Group Infanrix Hexa (3+1)|Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275373|NCT02759354|OG002|Outcome|Group Vaxelis (2+1)|Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275374|NCT02759354|OG003|Outcome|Group Infanrix Hexa (2+1)|Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275375|NCT02759354|OG000|Outcome|Group Vaxelis (2+1)|Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275376|NCT02759354|OG001|Outcome|Group Infanrix Hexa (2+1)|Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275377|NCT02759354|EG000|Reported Event|Group Vaxelis (3+1)|Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275378|NCT02759354|EG001|Reported Event|Group Infanrix Hexa (3+1)|Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275379|NCT02759354|EG002|Reported Event|Group Vaxelis (2+1)|Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275380|NCT02759354|EG003|Reported Event|Group Infanrix Hexa (2+1)|Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence.
11275381|NCT02759471|BG000|Baseline|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
11275382|NCT02759471|FG000|Participant Flow|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
11275383|NCT02759471|OG000|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
11275384|NCT02759471|OG001|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
10970329|NCT00910039|BG000|Baseline|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
11275385|NCT02759471|OG000|Outcome|Investigator Rating of Fit Preference|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
11275386|NCT02759471|EG000|Reported Event|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
11275387|NCT02759562|BG000|Baseline|Andecaliximab|"Double-Blind Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275388|NCT02759562|BG001|Baseline|Placebo|"Double-Blind Period: Placebo administered via subcutaneous injection weekly for 8 doses~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275389|NCT02759562|BG002|Baseline|Total|Total of all reporting groups
11275390|NCT02759562|FG000|Participant Flow|Andecaliximab|"Double-Blind Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275391|NCT02759562|FG001|Participant Flow|Placebo|"Double-Blind Period: Placebo administered via subcutaneous injection weekly for 8 doses~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275392|NCT02759562|OG000|Outcome|Andecaliximab|"Double-Blind Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275393|NCT02759562|OG001|Outcome|Placebo|"Double-Blind Period: Placebo administered via subcutaneous injection weekly for 8 doses~Open-Label Period: Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks"
11275394|NCT02759562|EG000|Reported Event|Andecaliximab (Double-Blind)|Andecaliximab 600 mg administered via subcutaneous injection weekly for 8 weeks
11275395|NCT02759562|EG001|Reported Event|Placebo (Double-Blind)|Placebo administered via subcutaneous injection weekly for 8 doses
11275396|NCT02759562|EG002|Reported Event|Andecaliximab (Open-Label)|Andecaliximab 600 mg administered via subcutaneous injection weekly for up to 16 weeks
11275397|NCT02759575|BG000|Baseline|Pembrolizumab|"Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin~Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses~Radiation Therapy: 70 Gy in 35 fractions over 7 weeks~Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses."
11286898|NCT02895347|FG000|Participant Flow|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
11275398|NCT02759575|FG000|Participant Flow|Pembrolizumab|"Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin~Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses~Radiation Therapy: 70 Gy in 35 fractions over 7 weeks~Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses."
11275399|NCT02759575|OG000|Outcome|Pembrolizumab|"Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin~Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses~Radiation Therapy: 70 Gy in 35 fractions over 7 weeks~Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses."
11275400|NCT02759575|EG000|Reported Event|Pembrolizumab|"Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin~Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses~Radiation Therapy: 70 Gy in 35 fractions over 7 weeks~Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses."
11275401|NCT02759692|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11275402|NCT02759692|FG000|Participant Flow|Senofilcon A/ Stenfilcon A/ Senofilcon A|Subjects randomized to this sequence received the senofilcon A lens during the first period, the stenfilcon A lens during the second period and the senofilcon A lens during the third period.
11275403|NCT02759692|FG001|Participant Flow|Stenfilcon A/ Senofilcon A/ Stenfilcon A|subjects randomized to this sequence received the stenfilcon A lens during the first period, the senofilcon A lens during the second period and the stenfilcon A lens during the third period.
11275404|NCT02759692|OG000|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
11275405|NCT02759692|OG001|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
11275406|NCT02759692|EG000|Reported Event|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
11275407|NCT02759692|EG001|Reported Event|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
11275408|NCT02759939|BG000|Baseline|Video + Prompt Card|A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.
11275409|NCT02759939|BG001|Baseline|Decision Aids + Training|A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).
11275410|NCT02759939|BG002|Baseline|Video + Prompt Card and Decision Aids + Training|"A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.~And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter)."
11275411|NCT02759939|BG003|Baseline|Usual Care|Care as usual.
11275412|NCT02759939|BG004|Baseline|Total|Total of all reporting groups
11275413|NCT02759939|FG000|Participant Flow|Video + Prompt Card|A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.
11275414|NCT02759939|FG001|Participant Flow|Decision Aids + Training|A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).
11275415|NCT02759939|FG002|Participant Flow|Video + Prompt Card and Decision Aids + Training|"A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.~And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter)."
11275416|NCT02759939|FG003|Participant Flow|Usual Care|Care as usual.
11275417|NCT02759939|OG000|Outcome|Video + Prompt Card|A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.
11275418|NCT02759939|OG001|Outcome|Decision Aids + Training|A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).
11286899|NCT02895347|FG001|Participant Flow|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
11275419|NCT02759939|OG002|Outcome|Video + Prompt Card and Decision Aids + Training|"A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.~And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter)."
11275420|NCT02759939|OG003|Outcome|Usual Care|Care as usual.
11275421|NCT02759939|EG000|Reported Event|Video + Prompt Card|A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.
11275422|NCT02759939|EG001|Reported Event|Decision Aids + Training|A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).
11275423|NCT02759939|EG002|Reported Event|Video + Prompt Card and Decision Aids + Training|"A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.~And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter)."
11275424|NCT02759939|EG003|Reported Event|Usual Care|Care as usual.
11275425|NCT02760056|BG000|Baseline|Liothyronine (Cytomel)|"Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week~Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week."
11275426|NCT02760056|BG001|Baseline|Placebo|"Subject will take matching placebo twice a day for one week~Placebo: Patient will receive a matching placebo to take twice daily for one week."
11275427|NCT02760056|BG002|Baseline|Total|Total of all reporting groups
11275428|NCT02760056|FG000|Participant Flow|Liothyronine (Cytomel)|"Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week~Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. If the study is fully enrolled, each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week."
11275429|NCT02760056|FG001|Participant Flow|Placebo|"Subject will take matching placebo twice a day for one week~Placebo: Patient will receive a matching placebo to take twice daily for one week."
11275430|NCT02760056|OG000|Outcome|Liothyronine (Cytomel)|"Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week~Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week."
11275431|NCT02760056|OG001|Outcome|Placebo|"Subject will take matching placebo twice a day for one week~Placebo: Patient will receive a matching placebo to take twice daily for one week."
11275432|NCT02760056|OG002|Outcome|All Participants|Measure value across cohorts.
11275433|NCT02760056|EG000|Reported Event|Liothyronine (Cytomel)|"Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week~Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week."
11275434|NCT02760056|EG001|Reported Event|Placebo|Patient will receive a matching placebo to take twice daily for one week.
11275435|NCT02760069|BG000|Baseline|Inhaled ISO + Oral Ondansetron|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47."
11275436|NCT02760069|BG001|Baseline|Inhaled ISO + Oral Placebo|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00"
11286900|NCT02895347|OG000|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
11275437|NCT02760069|BG002|Baseline|Inhaled Placebo + Oral Ondansetron|"Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.~Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes."
11275438|NCT02760069|BG003|Baseline|Total|Total of all reporting groups
11275439|NCT02760069|FG000|Participant Flow|Inhaled ISO + Oral Ondansetron|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47."
11275440|NCT02760069|FG001|Participant Flow|Inhaled ISO + Oral Placebo|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00"
11275441|NCT02760069|FG002|Participant Flow|Inhaled Placebo + Oral Ondansetron|"Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.~Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes."
11275442|NCT02760069|OG000|Outcome|Inhaled ISO + Oral Ondansetron|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47."
11275443|NCT02760069|OG001|Outcome|Inhaled ISO + Oral Placebo|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00"
11275444|NCT02760069|OG002|Outcome|Inhaled Placebo + Oral Ondansetron|"Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.~Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes."
11275445|NCT02760069|EG000|Reported Event|Inhaled ISO + Oral Ondansetron|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47."
11275446|NCT02760069|EG001|Reported Event|Inhaled ISO + Oral Placebo|"Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.~Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00"
11275447|NCT02760069|EG002|Reported Event|Inhaled Placebo + Oral Ondansetron|"Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.~Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.~Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes."
11275448|NCT02760264|BG000|Baseline|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/kg/day: Oral administration of 0.25 mg/kg/day daily for 14 days."
11275449|NCT02760264|BG001|Baseline|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/kg/day: Oral administration of 0.75 mg/kg/day daily for 14 days."
11275450|NCT02760264|BG002|Baseline|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/kg/day: Oral administration of 2.0 mg/kg/day daily for 14 days."
11275451|NCT02760264|BG003|Baseline|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/kg/day: Oral administration of 6 mg/kg/day daily for 14 days."
11275452|NCT02760264|BG004|Baseline|Total|Total of all reporting groups
11275453|NCT02760264|FG000|Participant Flow|Vamorolone 0.25 mg/kg/Day|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Oral administration of 0.25 mg/kg/day daily for 14 days."
11275454|NCT02760264|FG001|Participant Flow|Vamorolone 0.75 mg/kg/Day|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Oral administration of 0.75 mg/kg/day daily for 14 days."
11275455|NCT02760264|FG002|Participant Flow|Vamorolone 2.0 mg/kg/Day|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Oral administration of 2.0 mg/kg/day daily for 14 days."
11275456|NCT02760264|FG003|Participant Flow|Vamorolone 6.0 mg/kg/Day|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Oral administration of 6 mg/kg/day daily for 14 days."
11275457|NCT02760264|OG000|Outcome|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/kg/day: Oral administration of 0.25 mg/kg/day daily for 14 days."
11275458|NCT02760264|OG001|Outcome|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/kg/day: Oral administration of 0.75 mg/kg/day daily for 14 days."
11275459|NCT02760264|OG002|Outcome|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/kg/day: Oral administration of 2.0 mg/kg/day daily for 14 days."
11275460|NCT02760264|OG003|Outcome|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/kg/day: Oral administration of 6 mg/kg/day daily for 14 days."
11275461|NCT02760264|OG000|Outcome|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/kg/day: Oral administration of 2.0 mg/kg/day daily for 14 days."
11275462|NCT02760264|EG000|Reported Event|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/kg/day: Oral administration of 0.25 mg/kg/day daily for 14 days."
11275463|NCT02760264|EG001|Reported Event|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/kg/day: Oral administration of 0.75 mg/kg/day daily for 14 days."
11275464|NCT02760264|EG002|Reported Event|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/kg/day: Oral administration of 2.0 mg/kg/day daily for 14 days."
11275465|NCT02760264|EG003|Reported Event|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/kg/day: Oral administration of 6 mg/kg/day daily for 14 days."
11275466|NCT02760277|BG000|Baseline|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily for 24 weeks."
11275467|NCT02760277|BG001|Baseline|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily for 24 weeks."
11275468|NCT02760277|BG002|Baseline|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily for 24 weeks."
11275469|NCT02760277|BG003|Baseline|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily for 24 weeks."
11275470|NCT02760277|BG004|Baseline|Total|Total of all reporting groups
11275471|NCT02760277|FG000|Participant Flow|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily for 24 weeks."
11275472|NCT02760277|FG001|Participant Flow|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily for 24 weeks."
11275473|NCT02760277|FG002|Participant Flow|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily for 24 weeks."
11275474|NCT02760277|FG003|Participant Flow|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily for 24 weeks."
11275475|NCT02760277|OG000|Outcome|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily for 24 weeks."
11275476|NCT02760277|OG001|Outcome|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily for 24 weeks."
11275477|NCT02760277|OG002|Outcome|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily for 24 weeks."
11275478|NCT02760277|OG003|Outcome|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily for 24 weeks."
11275479|NCT02760277|EG000|Reported Event|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily for 24 weeks."
11275480|NCT02760277|EG001|Reported Event|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily for 24 weeks."
11275481|NCT02760277|EG002|Reported Event|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily for 24 weeks."
11275482|NCT02760277|EG003|Reported Event|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily for 24 weeks."
11275483|NCT02760368|BG000|Baseline|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64 mg Subcutaneous q4w +placebo q4w+ Methotrexate (oral)~Olokizumab q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial + placebo (sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules)"
11275484|NCT02760368|BG001|Baseline|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)~Olokizumab q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial"
11275485|NCT02760368|BG002|Baseline|Arm 3: Placebo q2w + Methotrexate|"Placebo Subcutaneous q2w + Methotrexate (oral)~Placebo q2w: sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules"
11275486|NCT02760368|BG003|Baseline|Total|Total of all reporting groups
11275487|NCT02760368|FG000|Participant Flow|Arm 2: Olokizumab q2w|"Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275488|NCT02760368|FG001|Participant Flow|Arm 1: Olokizumab q4w|"Olokizumab 64 mg Subcutaneous q4w +placebo+ Methotrexate (oral)~64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275489|NCT02760368|FG002|Participant Flow|Arm 3: Placebo|"Placebo Subcutaneous q2w + Methotrexate (oral)~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275490|NCT02760368|OG000|Outcome|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275491|NCT02760368|OG001|Outcome|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)~Olokizumab 64 mg Subcutaneous once every 4 weeks+placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+ concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275492|NCT02760368|OG002|Outcome|Arm 3: Placebo q2w + Methotrexate|"Placebo Subcutaneous q2w + Methotrexate (oral)~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275493|NCT02760368|EG000|Reported Event|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275494|NCT02760368|EG001|Reported Event|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)~Olokizumab 64 mg Subcutaneous once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
11275495|NCT02760368|EG002|Reported Event|Arm 3: Placebo q2w + Methotrexate|"Placebo Subcutaneous q2w + Methotrexate (oral)~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or~≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)"
10847399|NCT00283062|OG002|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
11275496|NCT02760407|BG000|Baseline|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64mg subcutaneous q4w+ placebo+Methotrexate~64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275497|NCT02760407|BG001|Baseline|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275498|NCT02760407|BG002|Baseline|Arm 3: Adalimumab q2w + Methotrexate|"Active Comparator, Adalimumab 40mg q2w subcutaneous + Methotrexate~Subjects were administered adalimumab 40 mg q2w via SC injection as an active comparator+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275499|NCT02760407|BG003|Baseline|Arm 4: Placebo q2w + Methotrexate|"Placebo subcutaneous q2w + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275500|NCT02760407|BG004|Baseline|Total|Total of all reporting groups
11275501|NCT02760407|FG000|Participant Flow|Arm 1: Olokizumab q4w|"Olokizumab 64mg subcutaneous q4w+ placebo+Methotrexate~64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275502|NCT02760407|FG001|Participant Flow|Arm 2: Olokizumab q2w|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275503|NCT02760407|FG002|Participant Flow|Arm 3: Adalimumab q2w|"Active Comparator, Adalimumab 40mg q2w subcutaneous + Methotrexate~subjects were administered adalimumab 40 mg q2w via SC injection as an active comparator +concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275504|NCT02760407|FG003|Participant Flow|Arm 4: Placebo q2w|"Placebo subcutaneous q2w + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275505|NCT02760407|OG000|Outcome|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64mg subcutaneous q4w+ placebo+Methotrexate~64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275506|NCT02760407|OG001|Outcome|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275507|NCT02760407|OG002|Outcome|Arm 3: Adalimumab q2w + Methotrexate|"Active Comparator, Adalimumab 40mg q2w subcutaneous + Methotrexate~Subjects were administered adalimumab 40 mg q2w via SC injection as an active comparator+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275508|NCT02760407|OG003|Outcome|Arm 4: Placebo q2w + Methotrexate|"Placebo subcutaneous q2w + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275509|NCT02760407|OG003|Outcome|Arm 4: Placebo q2w + Methotrexate|"Placebo subcutaneous q2w + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral,subcutaneous,or intramuscular)"
11275510|NCT02760407|EG000|Reported Event|Arm 1: Olokizumab q4w + Methotrexate|"Olokizumab 64mg subcutaneous q4w+ placebo+Methotrexate~64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275511|NCT02760407|EG001|Reported Event|Arm 2: Olokizumab q2w + Methotrexate|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275512|NCT02760407|EG002|Reported Event|Arm 3: Adalimumab q2w + Methotrexate|"Active Comparator, Adalimumab 40mg q2w subcutaneous + Methotrexate~Subjects were administered adalimumab 40 mg q2w via SC injection as an active comparator+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275513|NCT02760407|EG003|Reported Event|Arm 4: Placebo q2w + Methotrexate|"Placebo subcutaneous q2w + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275514|NCT02760433|BG000|Baseline|Arm 1: Olokizumab q4w|"Olokizumab 64mg subcutaneous q4w +placebo + Methotrexate~Olokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)"
11275515|NCT02760433|BG001|Baseline|Arm 2: Olokizumab q2w|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275516|NCT02760433|BG002|Baseline|Arm 4: Placebo-OKZ 64 mg q4w|refers to subjects who initially received placebo q2w, but then were re-randomized at week 16 to receive OKZ 64 mg q4w
11275517|NCT02760433|BG003|Baseline|Arm 5: Placebo-OKZ 64 mg q2w|refers to subjects who initially received placebo q2w, but then were re-randomized at week 16 to receive OKZ 64 mg q2w
11275518|NCT02760433|BG004|Baseline|Arm 6:Placebo Only|refers to subjects who were initially randomized to placebo, but who were not re-randomized to OKZ 64 mg q2w or OKZ 64 mg q4w
11275519|NCT02760433|BG005|Baseline|Total|Total of all reporting groups
11275520|NCT02760433|FG000|Participant Flow|Arm 1: Olokizumab q4w|"Olokizumab 64mg subcutaneous q4w +placebo + Methotrexate~Olokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)~There was no re-randomization at week 16 for this arm"
11275521|NCT02760433|FG001|Participant Flow|Arm 2: Olokizumab q2w|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)~There was no re-randomization at week 16 for this arm"
11275522|NCT02760433|FG002|Participant Flow|Arm 4: Placebo-OKZ 64 mg q4w|refers to subjects who initially received placebo q2w (Arm 3:Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate)), but then were re-randomized at week 16 to receive OKZ 64 mg q4w. Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6.
10847400|NCT00283062|OG003|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
11275523|NCT02760433|FG003|Participant Flow|Arm 5: Placebo-OKZ 64 mg q2w|refers to subjects who initially received placebo q2w (Arm 3:Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate)), but then were re-randomized at week 16 to receive OKZ 64 mg q2w. Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6.
11275524|NCT02760433|FG004|Participant Flow|Arm 6:Placebo Only|refers to subjects who were initially randomized to placebo q2w (Arm3:Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate)), but who were not re-randomized to OKZ 64 mg q2w or OKZ 64 mg q4w. Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6.
11275525|NCT02760433|OG000|Outcome|Arm 1: Olokizumab 64 mg q4w|"Olokizumab 64mg subcutaneous q4w +placebo + Methotrexate~Olokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)"
11275526|NCT02760433|OG001|Outcome|Arm 2: Olokizumab 64 mg q2w|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275527|NCT02760433|OG002|Outcome|Arm 3: Placebo q2w|"Placebo q2w subcutaneous + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)~Starting at Week 16, all subjects in the placebo group were randomized in a blinded fashion to receive either OKZ 64 mg q2w or OKZ 64 mg q4w;~Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6 reported previously"
11275528|NCT02760433|OG000|Outcome|Arm 1: Olokizumab q4w|"Olokizumab 64mg subcutaneous q4w +placebo + Methotrexate~Olokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)"
11275529|NCT02760433|OG001|Outcome|Arm 2: Olokizumab q2w|"Olokizumab 64mg subcutaneous q2w + Methotrexate~64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)"
11275530|NCT02760433|OG002|Outcome|Arm 3: Placebo q2w + Methotrexate|"Placebo q2w subcutaneous + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)~Starting at Week 16, all subjects in the placebo group were randomized in a blinded fashion to receive either OKZ 64 mg q2w or OKZ 64 mg q4w;~Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6 reported previously"
11275531|NCT02760433|OG002|Outcome|Arm 3: Placebo q2w|"Placebo q2w subcutaneous + Methotrexate~Placebo q2w subcutaneous + Methotrexate~Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)~Arm 3 (placebo q2w) consisted of subjects from arms 4, 5 and 6 reported previously Starting at Week 16, all subjects in the placebo group were randomized in a blinded fashion to receive either OKZ 64 mg q2w or OKZ 64 mg q4w;"
11275532|NCT02760433|EG000|Reported Event|Arm 1: OKZ 64 mg q4w|refers to subjects initially randomized to receive OKZ q4w and relates to AEs reported for this group during the total 24-week study treatment period
11275533|NCT02760433|EG001|Reported Event|Arm 2: OKZ 64 mg q2w|refers to subjects initially randomized to receive OKZ q2w and relates to AEs reported for this group during the total 24-week study treatment period
11275534|NCT02760433|EG002|Reported Event|Arm 3: Placebo q2w|refers to subjects initially randomized to receive placebo and relates only to AEs reported for this group during the 16-week treatment period up to re-randomization
11275535|NCT02760433|EG003|Reported Event|Arm 4: Placebo-OKZ 64 mg q4w|refers to subjects re-randomized to receive OKZ q4w and relates only to AEs reported for this group during the treatment period after re-randomization from Week 16 to Week 24
11275536|NCT02760433|EG004|Reported Event|Arm 5: Placebo-OKZ 64 mg q2w|refers to subjects re-randomized to receive OKZ q2w and relates only to AEs reported for this group during the treatment period after re-randomization from Week 16 to Week 24
11275537|NCT02760433|EG005|Reported Event|Arm 6: Any OKZ 64 mg q4w|refers to a combination of the AEs reported for the OKZ 64 mg q4w group and the Placebo-OKZ 64 mg q4w group
11275538|NCT02760433|EG006|Reported Event|Arm 7: Any OKZ 64 mg q2w|refers to a combination of the AEs reported for the OKZ 64 mg q2w group and the Placebo-OKZ 64 mg q2w group
11275539|NCT02760433|EG007|Reported Event|Arm 8:Total|refers to AEs reported for all subjects at all visits
11275540|NCT02760654|BG000|Baseline|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
11275541|NCT02760654|BG001|Baseline|Control|Treatment as usual
11275542|NCT02760654|BG002|Baseline|Total|Total of all reporting groups
11275543|NCT02760654|FG000|Participant Flow|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
11275544|NCT02760654|FG001|Participant Flow|Control|Treatment as usual
11275545|NCT02760654|OG000|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
11275546|NCT02760654|OG001|Outcome|Control|Treatment as usual
11275547|NCT02760654|EG000|Reported Event|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
11275548|NCT02760654|EG001|Reported Event|Control|Treatment as usual
11275549|NCT02760810|BG000|Baseline|Narafilcon A|All subjects wore the same lens throughout the study.
11275550|NCT02760810|FG000|Participant Flow|Narafilcon A|All subjects wore the same lens throughout the study.
11275551|NCT02760810|OG000|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
11275552|NCT02760810|EG000|Reported Event|Narafilcon A|All subjects wore the same lens throughout the study.
11275553|NCT02760862|BG000|Baseline|Group (I) (N=25)|"Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).~hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours"
11275554|NCT02760862|BG001|Baseline|Group (II) (N=25)|"group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).~mannitol 20% intravenous fluid: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance."
11275555|NCT02760862|BG002|Baseline|Total|Total of all reporting groups
11275556|NCT02760862|FG000|Participant Flow|Group (I) (N=25)|"Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).~hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours"
11275557|NCT02760862|FG001|Participant Flow|Group (II) (N=25)|"group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).~mannitol 20% intravenous fluid: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance."
11275558|NCT02760862|OG000|Outcome|Group (I) (N=25)|"Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).~hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours"
11275559|NCT02760862|OG001|Outcome|Group (II) (N=25)|"group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).~mannitol 20% intravenous fluid: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance."
11275560|NCT02760862|EG000|Reported Event|Group (I) (N=25)|"Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).~hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours"
11275561|NCT02760862|EG001|Reported Event|Group (II) (N=25)|"group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).~mannitol 20% intravenous fluid: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance."
11275562|NCT02760927|BG000|Baseline|Endotracheal Tube Fastener|"The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.~Endotracheal Tube Fastener: The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device."
11275563|NCT02760927|FG000|Participant Flow|Endotracheal Tube Fastener|"The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.~Endotracheal Tube Fastener: The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device."
11275564|NCT02760927|OG000|Outcome|Endotracheal Tube Fastener|"The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.~Endotracheal Tube Fastener: The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device."
11275565|NCT02760927|EG000|Reported Event|Endotracheal Tube Fastener|"The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.~Endotracheal Tube Fastener: The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device."
11275566|NCT02761252|BG000|Baseline|Bilastine+Montelukast|"Bilastine 20mg~Montelukast 10mg"
10970330|NCT00910039|FG000|Participant Flow|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
10970331|NCT00910039|OG000|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
10970332|NCT00910039|OG000|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
10970333|NCT00910039|EG000|Reported Event|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
10970334|NCT00910091|BG000|Baseline|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
10970335|NCT00910091|BG001|Baseline|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
11275567|NCT02761252|BG001|Baseline|Bilastine Monotherapy|"Bilastine 20mg~Placebo Montelukast 10mg"
11275568|NCT02761252|BG002|Baseline|Montelukast Monotherapy|"Montelukast 10mg~Placebo Bilastine 20mg"
11275569|NCT02761252|BG003|Baseline|Total|Total of all reporting groups
11275570|NCT02761252|FG000|Participant Flow|Bilastine+Montelukast|"Bilastine 20mg~Montelukast 10mg"
11275571|NCT02761252|FG001|Participant Flow|Bilastine Monotherapy|"Bilastine 20mg~Placebo Montelukast 10mg"
11275572|NCT02761252|FG002|Participant Flow|Montelukast Monotherapy|"Montelukast 10mg~Placebo Bilastine 20mg"
11275573|NCT02761252|OG000|Outcome|Bilastine+Montelukast|Bilastine 20mg+Montelukast 10mg
10970336|NCT00910091|BG002|Baseline|Total|Total of all reporting groups
11275574|NCT02761252|OG001|Outcome|Bilastine Monotherapy|"Bilastine 20mg~Placebo Montelukast 10mg"
11275575|NCT02761252|OG000|Outcome|Bilastine+Montelukast|Bilastine 20mg + Montelukast 10mg
11275576|NCT02761252|OG002|Outcome|Montelukast Monotherapy|"Montelukast 10mg~Placebo Bilastine 20mg"
11275577|NCT02761252|OG000|Outcome|Bilastine+Montelukast|"Bilastine 20mg~Montelukast 10mg"
11275578|NCT02761252|EG000|Reported Event|Bilastine+Montelukast|"Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment~Bilastine 20mg~Montelukast 10mg"
11275579|NCT02761252|EG001|Reported Event|Bilastine+Placebo Montelukast|"Bilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each.~Bilastine 20mg~Placebo Montelukast 10mg"
11275580|NCT02761252|EG002|Reported Event|Montelukast+Placebo Bilastine|"Placebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each.~Montelukast 10mg~Placebo Bilastine 20mg"
11275581|NCT02761330|BG000|Baseline|AllParticipants|All participants enrolled in study procedures.
11275582|NCT02761330|FG000|Participant Flow|Ketamine +ECT, Etomidate + ECT, Ketamine Sham|"Participants first received ECT treatment under Ketamine general anesthesia, then ECT treatment under Etomidate anesthesia, and finally participants received Ketamine general anesthesia with sham ECT.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
11275583|NCT02761330|FG001|Participant Flow|Ketamine +ECT, Ketamine Sham, Etomidate + ECT|"Participants first received ECT treatment under Ketamine general anesthesia, then Ketamine general anesthesia with sham ECT and finally participants received ECT treatment under Etomidate anesthesia.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
10970337|NCT00910091|FG000|Participant Flow|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
10970338|NCT00910091|FG001|Participant Flow|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
10970339|NCT00910091|OG000|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
10970340|NCT00910091|OG001|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
10970341|NCT00910091|OG001|Outcome|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
10970342|NCT00910091|EG000|Reported Event|A- BN 83495- 40mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~BN83495: BN83495 will be administered as a 40 mg tablet once a day orally"
10970343|NCT00910091|EG001|Reported Event|B- MA - 160mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~Megestrol Acetate (MA): MA will be administered orally as 160mg daily"
10970344|NCT00910208|BG000|Baseline|PCA 1 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970345|NCT00910208|BG001|Baseline|PCA 1.5 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970346|NCT00910208|BG002|Baseline|Non-PCA Comparison Group|"0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.~morphine: Intravenous morphine"
10970347|NCT00910208|BG003|Baseline|Total|Total of all reporting groups
10970348|NCT00910208|FG000|Participant Flow|PCA 1 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dose every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
11275584|NCT02761330|FG002|Participant Flow|Etomidate +ECT, Ketamine + ECT, Ketamine Sham|"Participants first received ECT treatment under Etomidate general anesthesia, then ECT treatment under Ketamine general anesthesia and finally participants received Ketamine general anesthesia with sham ECT.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
11275585|NCT02761330|FG003|Participant Flow|Etomidate +ECT, Ketamine Sham, Ketamine +ECT|"Participants first received ECT treatment under Etomidate general anesthesia, then Ketamine general anesthesia with sham ECT and finally participants received ECT treatment under Ketamine anesthesia.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
11275586|NCT02761330|FG004|Participant Flow|Ketamine Sham, Etomidate +ECT, Ketamine +ECT|"Participants first received Ketamine general anesthesia with sham ECT, then ECT treatment under Etomidate general anesthesia and finally participants received ECT treatment under Ketamine anesthesia.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
10970349|NCT00910208|FG001|Participant Flow|PCA 1.5 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970350|NCT00910208|FG002|Participant Flow|Non-PCA Comparison Group|"0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.~morphine: Intravenous morphine"
10970351|NCT00910208|OG000|Outcome|PCA 1 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970352|NCT00910208|OG001|Outcome|PCA 1.5 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970353|NCT00910208|OG002|Outcome|Non-PCA Comparison Group|"0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.~morphine: Intravenous morphine"
10970354|NCT00910208|EG000|Reported Event|PCA 1 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970355|NCT00910208|EG001|Reported Event|PCA 1.5 mg Demand Dose|"0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes~Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device~morphine: Intravenous morphine"
10970356|NCT00910208|EG002|Reported Event|Non-PCA Comparison Group|"0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.~morphine: Intravenous morphine"
10970357|NCT00910247|BG000|Baseline|Eslicarbazepine Acetate|"Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD~Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)"
10970358|NCT00910247|FG000|Participant Flow|Eslicarbazepine Acetate|"Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD~Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)"
10970359|NCT00910247|OG000|Outcome|Eslicarbazepine Acetate|"Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD~Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)"
10970360|NCT00910247|EG000|Reported Event|Eslicarbazepine Acetate|"Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD~Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)"
10970361|NCT00910273|BG000|Baseline|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
10970362|NCT00910273|BG001|Baseline|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
10970363|NCT00910273|BG002|Baseline|Total|Total of all reporting groups
10970364|NCT00910273|FG000|Participant Flow|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
10970365|NCT00910273|FG001|Participant Flow|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
10970366|NCT00910273|OG000|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
10970367|NCT00910273|OG001|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
10970368|NCT00910273|EG000|Reported Event|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
10970369|NCT00910273|EG001|Reported Event|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
10970370|NCT00910299|BG000|Baseline|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
10970371|NCT00910299|BG001|Baseline|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
10970372|NCT00910299|BG002|Baseline|Total|Total of all reporting groups
11286901|NCT02895347|OG001|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
10970373|NCT00910299|FG000|Participant Flow|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
10970374|NCT00910299|FG001|Participant Flow|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
10970375|NCT00910299|OG000|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
10970376|NCT00910299|OG001|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
10970377|NCT00910299|EG000|Reported Event|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
10970378|NCT00910299|EG001|Reported Event|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
10970379|NCT00910429|BG000|Baseline|Riociguat-Former Riociguat 1.0-2.5 mg|Participants were from the former riociguat (BAY 63-2521) treatment group of CHEST-1 on the same dose as they received on the last day of CHEST-1.
10970380|NCT00910429|BG001|Baseline|Riociguat-Former Placebo|Participants were from the former placebo group of CHEST-1. The starting dose in CHEST-2 was 1.0 mg riociguat three times one day.
10970381|NCT00910429|BG002|Baseline|Total|Total of all reporting groups
10970382|NCT00910429|FG000|Participant Flow|Riociguat-Former Riociguat 1.0-2.5 mg|Participants were from the former riociguat (BAY 63-2521) treatment group of CHEST-1 on the same dose as they received on the last day of CHEST-1.
10970383|NCT00910429|FG001|Participant Flow|Riociguat-Former Placebo|Participants were from the former placebo group of CHEST-1. The starting dose in CHEST-2 was 1.0 mg riociguat three times one day.
10970384|NCT00910429|OG000|Outcome|Riociguat-Former Riociguat 1.0-2.5 mg|Participants were from the former riociguat (BAY 63-2521) treatment group of CHEST-1 on the same dose as they received on the last day of CHEST-1.
10970385|NCT00910429|OG001|Outcome|Riociguat-Former Placebo|Participants were from the former placebo group of CHEST-1. The starting dose in CHEST-2 was 1.0 mg riociguat three times one day.
10970386|NCT00910429|EG000|Reported Event|Former Riociguat 1.0-2.5 mg|Subjects from the riociguat 1.0-2.5 mg group of CHEST-1 entered the extension study(CHEST-2) with the same dose as they received on the last day of CHEST-1 (Visit7).
10970387|NCT00910429|EG001|Reported Event|Former Placebo|Subjects from the placebo group of CHEST-1 entered the extension study (CHEST-2),the starting dose in CHEST-2 was 1.0 mg riociguat tid.
10970388|NCT00910481|BG000|Baseline|Elective IABP Insertion|Left ventricular ejection fraction was 23.6% (SD, 5.2%) in the elective IABP group
10970389|NCT00910481|BG001|Baseline|No Planned IABP Insertion|Left ventricular ejection fraction was 23.6% (SD, 5.5%) in the no planned IABP group
10970390|NCT00910481|BG002|Baseline|Total|Total of all reporting groups
10970391|NCT00910481|FG000|Participant Flow|Elective IABP Insertion|Intra-Aortic Balloon Pump: Elective IABP insertion before PCI
10970392|NCT00910481|FG001|Participant Flow|No Planned IABP Insertion|
10970393|NCT00910481|OG000|Outcome|Elective IABP Insertion|Intra-Aortic Balloon Pump: Elective IABP insertion before PCI
10970394|NCT00910481|OG001|Outcome|No Planned IABP Insertion|
10970395|NCT00910481|EG000|Reported Event|Elective IABP Insertion|Intra-Aortic Balloon Pump: Elective IABP insertion before PCI
10970396|NCT00910481|EG001|Reported Event|No Planned IABP Insertion|
10970397|NCT00910520|BG000|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970398|NCT00910520|BG001|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970399|NCT00910520|BG002|Baseline|Total|Total of all reporting groups
10970400|NCT00910520|FG000|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970401|NCT00910520|FG001|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970402|NCT00910520|OG000|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970403|NCT00910520|OG001|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970404|NCT00910520|EG000|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970405|NCT00910520|EG001|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970406|NCT00910624|BG000|Baseline|BOC + PEG/RBV: Prior Null Responders|"Participants who achieved null response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970407|NCT00910624|BG001|Baseline|BOC + PEG/RBV: Prior Partial Responders|"Participants who achieved partial response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970408|NCT00910624|BG002|Baseline|BOC + PEG/RBV: Prior Relapsers|"Participants who achieved prior relapse (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970409|NCT00910624|BG003|Baseline|BOC + PEG/RBV: Other|"Participants who were characterized as Other (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970410|NCT00910624|BG004|Baseline|Total|Total of all reporting groups
10970411|NCT00910624|FG000|Participant Flow|BOC + PEG/RBV: Prior Null Responders|"Participants who achieved null response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970412|NCT00910624|FG001|Participant Flow|BOC + PEG/RBV: Prior Partial Responders|"Participants who achieved partial response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970413|NCT00910624|FG002|Participant Flow|BOC + PEG/RBV: Prior Relapsers|"Participants who achieved prior relapse (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970414|NCT00910624|FG003|Participant Flow|BOC + PEG/RBV: Other|"Participants who were characterized as Other (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
11092304|NCT01539083|BG000|Baseline|Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
11275587|NCT02761330|FG005|Participant Flow|Ketamine Sham, Ketamine +ECT, Etomidate +ECT|"Participants first received Ketamine general anesthesia with sham ECT, then ECT treatment under Ketamine general anesthesia and finally participants received ECT treatment under Etomidate anesthesia.~Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose."
11275588|NCT02761330|OG000|Outcome|Etomidate + ECT|"General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization."
11275589|NCT02761330|OG001|Outcome|Ketamine + ECT|"General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.~Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.~Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization."
11275590|NCT02761330|OG002|Outcome|Ketamine Alone|"General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.~Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg."
11275591|NCT02761330|OG000|Outcome|Ketamine + ECT|General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
11275592|NCT02761330|OG001|Outcome|Etomidate + ECT|General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
11275593|NCT02761330|OG002|Outcome|Ketamine Alone|General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.
11275594|NCT02761330|OG000|Outcome|All Participants|All participants enrolled in study procedures
11275595|NCT02761330|OG000|Outcome|All Participants|All participants enrolled in study procedures.
11275596|NCT02761330|OG000|Outcome|AllParticipants|All participants enrolled in study procedures.
11275597|NCT02761330|EG000|Reported Event|Ketamine +ECT|General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
11275598|NCT02761330|EG001|Reported Event|Etomidate +ECT|General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
11275599|NCT02761330|EG002|Reported Event|Ketamine Sham|General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.
11275600|NCT02761629|BG000|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275601|NCT02761629|BG001|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275602|NCT02761629|BG002|Baseline|Total|Total of all reporting groups
11275603|NCT02761629|FG000|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
11275604|NCT02761629|FG001|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275605|NCT02761629|OG000|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275606|NCT02761629|OG001|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275607|NCT02761629|EG000|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275608|NCT02761629|EG001|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
11275609|NCT02761642|BG000|Baseline|Epoetin Beta|Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
11275610|NCT02761642|FG000|Participant Flow|Epoetin Beta|Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
11275611|NCT02761642|OG000|Outcome|Epoetin Beta|Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
11275612|NCT02761642|EG000|Reported Event|Epoetin Beta|Anemic breast cancer participants received epoetin beta (NeoRecormon®) at a dose of 30000 International Units (IU) as subcutaneous (SC) injection once every week for a total of 12 weeks. Adjustments in the dose were implemented based on the participant's blood hemoglobin levels.
11275613|NCT02761733|BG000|Baseline|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
11275614|NCT02761733|BG001|Baseline|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
11275615|NCT02761733|BG002|Baseline|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
11275616|NCT02761733|BG003|Baseline|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
11275617|NCT02761733|BG004|Baseline|Total|Total of all reporting groups
11275618|NCT02761733|FG000|Participant Flow|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
11275619|NCT02761733|FG001|Participant Flow|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
11275620|NCT02761733|FG002|Participant Flow|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
11275621|NCT02761733|FG003|Participant Flow|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
11275622|NCT02761733|OG000|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
11275623|NCT02761733|OG001|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
11275624|NCT02761733|OG002|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
11275625|NCT02761733|OG003|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
11275626|NCT02761733|EG000|Reported Event|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
11275627|NCT02761733|EG001|Reported Event|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
11275628|NCT02761733|EG002|Reported Event|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
11275629|NCT02761733|EG003|Reported Event|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
11275630|NCT02761915|BG000|Baseline|Dose Level 1|"Patients in Dose Level 1 will receive 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~1RG-CART"
11275631|NCT02761915|BG001|Baseline|Dose Level 2|"Patients in Dose Level 2 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~1RG-CART"
11275632|NCT02761915|BG002|Baseline|Dose Level 3|"Patients in Dose Level 3 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Cyclophosphamide~Fludarabine~Leukapheresis~1RG-CART"
11275633|NCT02761915|BG003|Baseline|Dose Level 4|"Patients in Dose Level 4 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^8 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Cyclophosphamide~Fludarabine~Leukapheresis~1RG-CART"
11275634|NCT02761915|BG004|Baseline|Dose Level 5|"If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Cyclophosphamide~Fludarabine~Leukapheresis~1RG-CART"
11275635|NCT02761915|BG005|Baseline|Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP|"Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.~Assigned Interventions:~Leukapheresis"
11275636|NCT02761915|BG006|Baseline|Total|Total of all reporting groups
11275637|NCT02761915|FG000|Participant Flow|Dose Level 1|"Patients in Dose Level 1 will receive 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~1RG-CART"
11275638|NCT02761915|FG001|Participant Flow|Dose Level 2|"Patients in Dose Level 2 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~1RG-CART/m^2"
11275639|NCT02761915|FG002|Participant Flow|Dose Level 3|"Patients in Dose Level 3 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275640|NCT02761915|FG003|Participant Flow|Dose Level 4|"Patients in Dose Level 4 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^8 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275641|NCT02761915|FG004|Participant Flow|Dose Level 5|"If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275642|NCT02761915|FG005|Participant Flow|Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP|"Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.~Assigned Interventions:~Leukapheresis"
11275643|NCT02761915|OG000|Outcome|Dose Level 1|"Patients in Dose Level 1 will receive 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~1RG-CART"
11275644|NCT02761915|OG001|Outcome|Dose Level 2|"Patients in Dose Level 2 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis Cyclophosphamide~1RG-CART/m^2"
11275645|NCT02761915|OG002|Outcome|Dose Level 3|"Patients in Dose Level 3 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis Cyclophosphamide Fludarabine~1RG-CART/m^2"
10847401|NCT00283062|EG000|Reported Event|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
11275646|NCT02761915|OG003|Outcome|Dose Level 4|"Patients in Dose Level 4 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^8 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis Cyclophosphamide Fludarabine~1RG-CART/m^2"
11275647|NCT02761915|OG004|Outcome|Dose Level 5|"If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Leukapheresis Cyclophosphamide Fludarabine~1RG-CART/m^2"
11275648|NCT02761915|OG005|Outcome|Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP|"Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.~Assigned Interventions:~Leukapheresis"
11275649|NCT02761915|OG002|Outcome|Dose Level 3|"Patients in Dose Level 3 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275650|NCT02761915|OG003|Outcome|Dose Level 4|"Patients in Dose Level 4 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^8 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275651|NCT02761915|OG004|Outcome|Dose Level 5|"If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275652|NCT02761915|OG001|Outcome|Dose Level 2|"Patients in Dose Level 2 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~1RG-CART/m^2"
11275653|NCT02761915|OG004|Outcome|Dose Level 5|"f the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART/m^2"
11275654|NCT02761915|EG000|Reported Event|Dose Level 1|"Patients in Dose Level 1 will receive 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~1RG-CART"
11275655|NCT02761915|EG001|Reported Event|Dose Level 2|"Patients in Dose Level 2 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~1RG-CART"
11275656|NCT02761915|EG002|Reported Event|Dose Level 3|"Patients in Dose Level 3 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^7 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART"
11275657|NCT02761915|EG003|Reported Event|Dose Level 4|"Patients in Dose Level 4 will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10^8 1RG-CART/m^2 IV on Day 0.~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART"
11275658|NCT02761915|EG004|Reported Event|Dose Level 5|"If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10^8 1RG-CART/m^2 IV which could be be split over two days (Day 0 and Day 1).~Assigned Interventions:~Leukapheresis~Cyclophosphamide~Fludarabine~1RG-CART"
11275659|NCT02761967|BG000|Baseline|Physical Activity|"The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the method of SWEP, for an hour a day, three days a week.~After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.~Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes."
11275660|NCT02761967|BG001|Baseline|No Exercise|"Not take place during the gestation period between gestation week 20 to 37 any physical exercise.~Not take place during the postpartum period any physical exercise."
11275661|NCT02761967|BG002|Baseline|Total|Total of all reporting groups
11275662|NCT02761967|FG000|Participant Flow|Physical Activity|"º Phase: Swep Method. Warm up: The warm-up exercise will take place in a small vessel, where the water depth is around the thighs.~Central part of the activity: It is be held in the large vessel, exercise intensity will increase in order to keep within the limits for an exercise of moderate, use different devices support to carry it out and exercises of strength, endurance and pelvic elasticity are included.~Phase cool down: In this phase the participants will seek to return to calm, will be done in the small vessel having 3-4 ° C more than the large glass. exercises to progressively reducing the intensity and ending with relaxation exercises will be conducted .~º Phase: Low Pressure Fitness. Concluded the postpartum period. Women begin a program of recovery postpartum 12 weeks, 3 times a week in sessions of one hour. They perform warm-up exercises, a central part of Low Pressure Fitness exercises and end with stretching exercises."
11275663|NCT02761967|FG001|Participant Flow|No Exercise|"Not take place during the gestation period between gestation week 20 to 37 any physical exercise.~Not take place during the postpartum period any physical exercise."
11275664|NCT02761967|OG000|Outcome|Physical Activity|"The women in the EG performed moderate physical exercise in water, following the SWEP method (Study of Water-based Exercise during Pregnancy). It consists of performing moderate physical exercise in an aquatic environment from weeks 20 to 37 of gestation. The sessions take place three times weekly, with a duration of 60 minutes each (45 minutes of activity followed by 15 minutes of relaxation). The sessions are composed of three phases: a) warm-up; b) the main phase, divided into aerobic exercise and strength-endurance exercises, designed specifically for pregnant women; c) stretching and relaxation.~After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes."
11275665|NCT02761967|OG001|Outcome|No Exercise|"The CG received the standard recommendations during pregnancy, including guidelines from the midwife on the positive effects of physical exercise. These participants received the usual visits from healthcare providers (midwives, obstetricians and family doctor) during pregnancy, as did those in the EG.~After the postpartum period, the women in the control group did not perform regulated physical activity."
11275666|NCT02761967|OG000|Outcome|Physical Activity|"The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the SWEP method, for an hour a day, three days a week.~After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.~Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes."
11275667|NCT02761967|OG001|Outcome|No Exercise|"Not take place during the gestation period between gestation week 20 to 37 any physical exercise.~Not take place during the postpartum period any physical exercise."
11337662|NCT03590613|FG001|Participant Flow|Treatment Sequence B: 60mg TID /PBO TID /120mg TID /240mg TID|Participants in this arm received GSK2982772 60 mg TID in TP1, PBO TID in TP2, GSK2982772 120mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 and placebo was administered at 0 hour (starting dose), 7 hours (second dose) and 14 hours (third dose) on Day 1 in each TP. Participants had fasted overnight for 8 hours before first dose. Each TP was followed by a washout period of at least 7 days, for each participant.
10847402|NCT00283062|EG001|Reported Event|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
10847403|NCT00283062|EG002|Reported Event|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
10847404|NCT00283062|EG003|Reported Event|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
11275668|NCT02761967|OG000|Outcome|Physical Activity|"The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the method of SWEP, for an hour a day, three days a week.~After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.~Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes."
11275669|NCT02761967|EG000|Reported Event|Physical Activity|"The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the method of SWEP, for an hour a day, three days a week.~After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.~Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes."
11275670|NCT02761967|EG001|Reported Event|No Exercise|"Not take place during the gestation period between gestation week 20 to 37 any physical exercise.~Not take place during the postpartum period any physical exercise."
11275671|NCT02761980|BG000|Baseline|Placebo|Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275672|NCT02761980|BG001|Baseline|Ibuprofen 250 mg+Acetaminophen 500 mg|Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275673|NCT02761980|BG002|Baseline|Ibuprofen 250 mg|Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275674|NCT02761980|BG003|Baseline|Acetaminophen 500 mg|Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275675|NCT02761980|BG004|Baseline|Total|Total of all reporting groups
11275676|NCT02761980|FG000|Participant Flow|Placebo|Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275677|NCT02761980|FG001|Participant Flow|Ibuprofen 250 mg+Acetaminophen 500 mg|Participants received single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275678|NCT02761980|FG002|Participant Flow|Ibuprofen 250 mg|Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275679|NCT02761980|FG003|Participant Flow|Acetaminophen 500 mg|Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275680|NCT02761980|OG000|Outcome|Placebo|Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
10847405|NCT00283075|BG000|Baseline|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
10847406|NCT00283075|FG000|Participant Flow|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
10847407|NCT00283075|FG001|Participant Flow|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
11275681|NCT02761980|OG001|Outcome|Ibuprofen 250 mg+Acetaminophen 500 mg|Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
10847408|NCT00283075|OG000|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
11275682|NCT02761980|OG002|Outcome|Ibuprofen 250 mg|Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275683|NCT02761980|OG003|Outcome|Acetaminophen 500 mg|Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275684|NCT02761980|EG000|Reported Event|Placebo|Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275685|NCT02761980|EG001|Reported Event|Ibuprofen 250 mg+Acetaminophen 500 mg|Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275686|NCT02761980|EG002|Reported Event|Ibuprofen 250 mg|Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275687|NCT02761980|EG003|Reported Event|Acetaminophen 500 mg|Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.
11275688|NCT02761993|BG000|Baseline|Group 1|"Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275689|NCT02761993|BG001|Baseline|Group 2|"Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275690|NCT02761993|BG002|Baseline|Group 3|"Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.~Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275691|NCT02761993|BG003|Baseline|Total|Total of all reporting groups
11275692|NCT02761993|FG000|Participant Flow|Group 1|"Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275693|NCT02761993|FG001|Participant Flow|Group 2|"Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275694|NCT02761993|FG002|Participant Flow|Group 3|"Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.~Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275695|NCT02761993|OG000|Outcome|Group 1|"Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275696|NCT02761993|OG001|Outcome|Group 2|"Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275697|NCT02761993|OG002|Outcome|Group 3|"Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.~Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275698|NCT02761993|EG000|Reported Event|Group 1|"Group 1: 1XST266 dosed as per regimen 1.~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275699|NCT02761993|EG001|Reported Event|Group 2|"Group 2: 1XST266 as per regimen 2.~ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275700|NCT02761993|EG002|Reported Event|Group 3|"Group 3: Placebo dosed as per regimen 1.~Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual)."
11275701|NCT02762071|BG000|Baseline|Interscalene Nerve Block|"Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.~Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist."
11275702|NCT02762071|BG001|Baseline|Liposomal Bupivacaine|"Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.~Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon."
11275703|NCT02762071|BG002|Baseline|Total|Total of all reporting groups
11275704|NCT02762071|FG000|Participant Flow|Interscalene Nerve Block|"Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.~Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist."
11275705|NCT02762071|FG001|Participant Flow|Liposomal Bupivacaine|Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
11275706|NCT02762071|OG000|Outcome|Interscalene Nerve Block|"Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.~Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist."
11275707|NCT02762071|OG001|Outcome|Liposomal Bupivacaine|"Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.~Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon."
11275708|NCT02762071|OG001|Outcome|Liposomal Bupivacaine|Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
11275709|NCT02762071|EG000|Reported Event|Interscalene Nerve Block|"Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.~Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist."
11275710|NCT02762071|EG001|Reported Event|Liposomal Bupivacaine|"Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.~Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon."
11275711|NCT02762084|BG000|Baseline|Patidegib Gel 2%|Applied topically twice daily for 26 weeks
11275712|NCT02762084|BG001|Baseline|Patidegib Gel 4%|Applied topically twice daily for 26 weeks
11275713|NCT02762084|BG002|Baseline|Vehicle Gel|Applied topically twice daily for 26 weeks
11275714|NCT02762084|BG003|Baseline|Total|Total of all reporting groups
11275715|NCT02762084|FG000|Participant Flow|Patidegib Gel 2%|Applied topically twice daily for 26 weeks
11275716|NCT02762084|FG001|Participant Flow|Patidegib Gel 4%|Applied topically twice daily for 26 weeks
11275717|NCT02762084|FG002|Participant Flow|Vehicle Gel|Applied topically twice daily for 26 weeks
11275718|NCT02762084|OG000|Outcome|Patidegib Gel 2%|Applied topically twice daily for 26 weeks
11275719|NCT02762084|OG001|Outcome|Patidegib Gel 4%|Applied topically twice daily for 26 weeks
11275720|NCT02762084|OG002|Outcome|Vehicle Gel|Applied topically twice daily for 26 weeks
11275721|NCT02762084|OG000|Outcome|Patidegib Gel|Patidegib: 2% or 4% gel applied topically twice daily for 26 weeks
11275722|NCT02762084|OG001|Outcome|Vehicle Gel|Applied topically twice daily for 26 weeks
11275723|NCT02762084|EG000|Reported Event|Patidegib Gel 2%|Applied topically twice daily for 26 weeks
11275724|NCT02762084|EG001|Reported Event|Patidegib Gel 4%|Applied topically twice daily for 26 weeks
11275725|NCT02762084|EG002|Reported Event|Vehicle Gel|Applied topically twice daily for 26 weeks
11275726|NCT02762331|BG000|Baseline|Vitamin C|"Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours.~Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients~4 subjects total~Age: Between 32 and 72~1 Female 3 Male~1 Black or African American/Non-Hispanic 3 White/Non-Hispanic~Region of enrollment: USA"
11275727|NCT02762331|BG001|Baseline|Normal Saline|"Intravenous normal saline 50 mL every six hours for 48 hours~Placebo: Placebo intervention~2 subjects total~Age: 50; 74 2 Males 2 White/Non-Hispanic Region of enrollment: USA"
11275728|NCT02762331|BG002|Baseline|Total|Total of all reporting groups
11275729|NCT02762331|FG000|Participant Flow|Vitamin C|"Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours.~Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients"
11275730|NCT02762331|FG001|Participant Flow|Normal Saline|"Intravenous normal saline 50 mL every six hours for 48 hours~Placebo: Placebo intervention"
11275731|NCT02762331|OG000|Outcome|Vitamin C|"Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours.~Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients"
11275732|NCT02762331|OG001|Outcome|Normal Saline|"Intravenous normal saline 50 mL every six hours for 48 hours~Placebo: Placebo intervention"
11275733|NCT02762331|EG000|Reported Event|Vitamin C|"Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours.~Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients~4 subjects total~Age: Between 32 and 72~1 Female 3 Male~1 Black or African American/Non-Hispanic 3 White/Non-Hispanic~Region of enrollment: USA No Adverse Events"
11275734|NCT02762331|EG001|Reported Event|Normal Saline|"Intravenous normal saline 50 mL every six hours for 48 hours~Placebo: Placebo intervention~2 subjects total~Age: 50; 74 2 Males 2 White/Non-Hispanic~Region of enrollment: USA No Adverse Events"
11275735|NCT02762370|BG000|Baseline|FX006 32 mg|FX006: Single 5 mL IA injection
11275736|NCT02762370|BG001|Baseline|TCA IR 40 mg|TCA IR: Single 1 mL IA injection
11275737|NCT02762370|BG002|Baseline|Total|Total of all reporting groups
11275738|NCT02762370|FG000|Participant Flow|FX006 32 mg|18 subjects received FX006 32 mg as a single 5 mL intra-articular (IA) injection
11275739|NCT02762370|FG001|Participant Flow|TCA IR 40 mg|15 subjects received triamcinolone acetonide injectable suspension, immediate release (TCA IR) 40 mg as a single 1 mL IA injection
11275740|NCT02762370|OG000|Outcome|FX006 32 mg|"Drug: FX006 Single intra-articular injection~FX006 32 mg"
11275741|NCT02762370|OG001|Outcome|TCA IR 40 mg|"Drug: TCA IR Single intra-articular injection~TCA IR 40 mg"
11275742|NCT02762370|OG000|Outcome|FX006 32 mg|Single 5 mL IA injection
11275743|NCT02762370|OG001|Outcome|TCA IR 40 mg|Single 1 mL IA injection
11275744|NCT02762370|EG000|Reported Event|FX006 32 mg|"Drug: FX006 Single intra-articular injection~FX006 32 mg"
11275745|NCT02762370|EG001|Reported Event|TCA IR 40 mg|"Drug: TCA IR Single intra-articular injection~TCA IR 40 mg"
11275746|NCT02762500|BG000|Baseline|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily for 8 weeks
11275747|NCT02762500|BG001|Baseline|Placebo|Matching placebo by mouth once daily for 8 weeks
11275748|NCT02762500|BG002|Baseline|Total|Total of all reporting groups
11275749|NCT02762500|FG000|Participant Flow|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily for 8 weeks
10847409|NCT00283075|OG000|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
11275750|NCT02762500|FG001|Participant Flow|Placebo|Matching placebo by mouth once daily for 8 weeks
11275751|NCT02762500|OG000|Outcome|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 8 weeks~LYC-30937-EC"
11275752|NCT02762500|OG001|Outcome|Placebo PO QD|"Matching placebo by mouth once daily for 8 weeks~Placebo"
11275753|NCT02762500|EG000|Reported Event|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 8 weeks~LYC-30937-EC"
11275754|NCT02762500|EG001|Reported Event|Placebo PO QD|"Matching placebo by mouth once daily for 8 weeks~Placebo"
11275755|NCT02762513|BG000|Baseline|Axitinib|Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
11275756|NCT02762513|FG000|Participant Flow|Axitinib|Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
11275757|NCT02762513|OG000|Outcome|Axitinib|Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
11275758|NCT02762513|EG000|Reported Event|Axitinib|Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
11275759|NCT02762565|BG000|Baseline|Breast Scanner|PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
11275760|NCT02762565|FG000|Participant Flow|Breast Scanner|One time use of PEFS system (Product Name: Intelligent Breast Exam™ or iBE™) on breast
11275761|NCT02762565|OG000|Outcome|Breast Scanner|PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
11275762|NCT02762565|EG000|Reported Event|Breast Scanner|PEFS system (Product Name: Intelligent Breast Exam™ or iBE™
11275763|NCT02762578|BG000|Baseline|IDegAsp BID|Subjects received subcutaneous (s.c.) injections of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) ≤ 5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on the day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275764|NCT02762578|BG001|Baseline|BIAsp 30 BID|Subjects received s.c. injections of biphasic insulin aspart 30 (BIAsp 30, a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) BID for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner SMPG ≤5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on the remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275765|NCT02762578|BG002|Baseline|Total|Total of all reporting groups
11275766|NCT02762578|FG000|Participant Flow|IDegAsp BID|Subjects received subcutaneous (s.c.) injections of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) ≤ 5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on the day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275767|NCT02762578|FG001|Participant Flow|BIAsp 30 BID|Subjects received s.c. injections of biphasic insulin aspart 30 (BIAsp 30, a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) BID for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner SMPG ≤5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on the remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275768|NCT02762578|OG000|Outcome|IDegAsp BID|Subjects received subcutaneous (s.c.) injections of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) ≤ 5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on the day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
10847410|NCT00283075|OG000|Outcome|Day 7|Tumor marker response at Day 7 after the first implantation.
11214837|NCT02294630|EG002|Reported Event|Dose Schedule III|"Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214838|NCT02294630|EG003|Reported Event|Dose Schedule IV|"Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.~Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer."
11214839|NCT02294682|BG000|Baseline|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214840|NCT02294682|BG001|Baseline|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214841|NCT02294682|BG002|Baseline|Total|Total of all reporting groups
11214842|NCT02294682|FG000|Participant Flow|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214843|NCT02294682|FG001|Participant Flow|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214844|NCT02294682|OG000|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214845|NCT02294682|OG001|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214846|NCT02294682|EG000|Reported Event|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214847|NCT02294682|EG001|Reported Event|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
11214848|NCT02294734|BG000|Baseline|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214849|NCT02294734|BG001|Baseline|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214850|NCT02294734|BG002|Baseline|Total|Total of all reporting groups
11214851|NCT02294734|FG000|Participant Flow|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214852|NCT02294734|FG001|Participant Flow|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214853|NCT02294734|OG000|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214854|NCT02294734|OG001|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214855|NCT02294734|OG001|Outcome|GSK2269557 1000 µg|Participants received 1000 µg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214856|NCT02294734|OG000|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214857|NCT02294734|EG000|Reported Event|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214858|NCT02294734|EG001|Reported Event|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
11214859|NCT02294773|BG000|Baseline|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11275769|NCT02762578|OG001|Outcome|BIAsp 30 BID|Subjects received s.c. injections of biphasic insulin aspart 30 (BIAsp 30, a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) BID for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner SMPG ≤5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on the remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275770|NCT02762578|EG000|Reported Event|IDegAsp BID|Subjects received subcutaneous (s.c.) injections of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) ≤ 5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on the day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275771|NCT02762578|EG001|Reported Event|BIAsp 30 BID|Subjects received s.c. injections of biphasic insulin aspart 30 (BIAsp 30, a mixture of soluble insulin aspart [IAsp] 30% and protaminated IAsp 70%) BID for 26 weeks. Subjects started insulin treatment at dose corresponding to their pre-trial insulin treatment. The insulin dose adjustments aimed to reach pre-breakfast and pre-dinner SMPG ≤5.0 mmol/L, based on the subject's pre-breakfast and pre-dinner SMPG. The dose taken with main evening meal was adjusted according to mean pre-breakfast plasma glucose measured on day of adjustment and the two preceding days. The dose taken at breakfast was adjusted according to mean pre-main evening meal plasma glucose measured on the three days preceding the adjustment day. If one of the PG values was below target (< 4.0 mmol/L), the corresponding dose was to be reduced. If one or more SMPG values were missing, the adjustment was to be performed on the remaining SMPG values. Subjects continued the pre-trial treatment with metformin at stable dose.
11275772|NCT02762799|BG000|Baseline|Leucostim® --> Neupogen®, Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275773|NCT02762799|BG001|Baseline|Neupogen® --> Leucostim®, Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275774|NCT02762799|BG002|Baseline|Leucostim® --> Neupogen®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275775|NCT02762799|BG003|Baseline|Neupogen® --> Leucostim®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275776|NCT02762799|BG004|Baseline|Total|Total of all reporting groups
11275777|NCT02762799|FG000|Participant Flow|Leucostim® --> Neupogen®, Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275778|NCT02762799|FG001|Participant Flow|Neupogen® --> Leucostim®, Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275779|NCT02762799|FG002|Participant Flow|Leucostim® --> Neupogen®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275780|NCT02762799|FG003|Participant Flow|Neupogen® --> Leucostim®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275781|NCT02762799|OG000|Outcome|Leucostim® Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1 (in Leucostim® --> Neupogen® group) or single subcutaneous injection Leucostim® on Day 29 (in Neupogen® --> Leucostim® group).~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275782|NCT02762799|OG001|Outcome|Neupogen® Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1 (in Neupogen® --> Leucostim® group) or single subcutaneous injection Leucostim® on Day 29 (in Leucostim®-->Neupogen® group).~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275783|NCT02762799|OG002|Outcome|Leucostim® Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 (in Leucostim® --> Neupogen® group) or single intravenous injection Leucostim® on Day 29 (in Neupogen®--> Leucostim® group)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
10847411|NCT00283075|OG001|Outcome|Day 14|Tumor marker response at Day 14 after the first implantation.
10847412|NCT00283075|OG002|Outcome|Day 21|Tumor marker response at Day 21 after the first implantation.
10847413|NCT00283075|OG003|Outcome|Day 28|Tumor marker response at Day 28 after the first implantation.
11275784|NCT02762799|OG003|Outcome|Neupogen® Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 (in Neupogen® --> Leucostim® group) or subcutaneous intravenous Leucostim® on Day 29 (in Leucostim®-->Neupogen® group)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275785|NCT02762799|OG000|Outcome|Leucostim® Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 (in Leucostim® --> Neupogen® group) or single intravenous injection Leucostim® on Day 29 (in Neupogen®--> Leucostim® group)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275786|NCT02762799|OG001|Outcome|Neupogen® Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 (in Neupogen® --> Leucostim® group) or subcutaneous intravenous Leucostim® on Day 29 (in Leucostim®-->Neupogen® group)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275787|NCT02762799|EG000|Reported Event|Leucostim®, Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1(in group Leucostim®-->Neupogen®) or single subcutaneous injection Leucostim® on Day 29 (in group Neupogen® --> Leucostim®)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275788|NCT02762799|EG001|Reported Event|Neupogen® Subcutaneous Injections|"Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1(in group Neupogen®-->Leucostim®) or single subcutaneous injection Neupogen® on Day 29 (in group Leucostim®-->Neupogen®)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275789|NCT02762799|EG002|Reported Event|Leucostim®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1(in group Leucostim®-->Neupogen®) or single subcutaneous injection Leucostim® on Day 29 (in group Neupogen® --> Leucostim®)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275790|NCT02762799|EG003|Reported Event|Neupogen®, Intravenous Injections|"Healthy volunteers in this group received single intravenous injection Neupogen®, on Day 1(in group Neupogen®-->Leucostim®) or single subcutaneous injection Neupogen® on Day 29 (in group Leucostim®-->Neupogen®)~Leucostim®: Leucostim® is filgrastim biosimilar.~Neupogen®"
11275791|NCT02762877|BG000|Baseline|A - NSCLC All Comers Regardless of Genomic Alteration Status|Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
11275792|NCT02762877|BG001|Baseline|B - Progressing on EGFR Targeted Therapies|Patients with non-squamous NSCLC progressing on erlotinib, gefitinib, or afatinib
10847414|NCT00283075|OG000|Outcome|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
10847415|NCT00283075|OG001|Outcome|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
10847416|NCT00283075|EG000|Reported Event|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
10847417|NCT00283244|BG000|Baseline|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
11275793|NCT02762877|BG002|Baseline|Total|Total of all reporting groups
11275794|NCT02762877|FG000|Participant Flow|A - NSCLC All Comers Regardless of Genomic Alteration Status|Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
11275795|NCT02762877|FG001|Participant Flow|B - Progressing on EGFR Targeted Therapies|Patients with non-squamous NSCLC progressing on erlotinib, gefitinib, or afatinib
11275796|NCT02762877|OG000|Outcome|A - NSCLC All Comers Regardless of Genomic Alteration Status|Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
11275797|NCT02762877|OG000|Outcome|Patients With Non-squamous NSCLC Either Newly Diagnosed or Pro|Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib).
11275798|NCT02762877|OG000|Outcome|Patients With Non-squamous NSCLC Who Are Progressing on Erloti|Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib
11275799|NCT02762877|EG000|Reported Event|A - NSCLC All Comers Regardless of Genomic Alteration Status|Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
11275800|NCT02762877|EG001|Reported Event|B - Progressing on EGFR Targeted Therapies|Patients with non-squamous NSCLC progressing on erlotinib, gefitinib, or afatinib
11275801|NCT02762994|BG000|Baseline|BCD-085, 40 mg|"Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275802|NCT02762994|BG001|Baseline|BCD-085, 80 mg|"Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275803|NCT02762994|BG002|Baseline|BCD-085, 120 mg|"Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275804|NCT02762994|BG003|Baseline|Placebo|"Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~Placebo"
11275805|NCT02762994|BG004|Baseline|Total|Total of all reporting groups
11275806|NCT02762994|FG000|Participant Flow|BCD-085, 40 mg|"Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275807|NCT02762994|FG001|Participant Flow|BCD-085, 80 mg|"Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275808|NCT02762994|FG002|Participant Flow|BCD-085, 120 mg|"Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275809|NCT02762994|FG003|Participant Flow|Placebo|"Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~Placebo"
11275810|NCT02762994|OG000|Outcome|BCD-085, 40 mg|"Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275811|NCT02762994|OG001|Outcome|BCD-085, 80 mg|"Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275812|NCT02762994|OG002|Outcome|BCD-085, 120 mg|"Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275813|NCT02762994|OG003|Outcome|Placebo|"Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~Placebo"
11275814|NCT02762994|OG000|Outcome|BCD-085, 40 mg|"Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275815|NCT02762994|OG001|Outcome|BCD-085, 80 mg|"Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275816|NCT02762994|OG002|Outcome|BCD-085, 120 mg|"Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275817|NCT02762994|OG003|Outcome|Placebo|"Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~Placebo"
11275818|NCT02762994|EG000|Reported Event|BCD-085, 40 mg|"Patients will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275819|NCT02762994|EG001|Reported Event|BCD-085, 80 mg|"Patients will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275820|NCT02762994|EG002|Reported Event|BCD-085, 120 mg|"Patients will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~BCD-085"
11275821|NCT02762994|EG003|Reported Event|Placebo|"Patients will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.~Placebo"
11275822|NCT02763046|BG000|Baseline|Secukinumab - Delayed NSAID Tapering|"Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (delayed tapering)."
11275823|NCT02763046|BG001|Baseline|Secukinumab - Early NSAID Tapering|"Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (early tapering)."
11275824|NCT02763046|BG002|Baseline|Placebo|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20).~NSAID tapering allowed from Week 4."
11275825|NCT02763046|BG003|Baseline|Total|Total of all reporting groups
11275826|NCT02763046|FG000|Participant Flow|Secukinumab - Delayed NSAID Tapering|"Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (delayed tapering)."
11275827|NCT02763046|FG001|Participant Flow|Secukinumab - Early NSAID Tapering|"Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (early tapering)."
11275828|NCT02763046|FG002|Participant Flow|Placebo|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20).~NSAID tapering allowed from Week 4."
11275829|NCT02763046|OG000|Outcome|Secukinumab - Pooled|The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
11275830|NCT02763046|OG001|Outcome|Placebo|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20).~NSAID tapering allowed from Week 4."
10847418|NCT00283244|BG001|Baseline|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
11275831|NCT02763046|OG000|Outcome|Secukinumab - Delayed NSAID Tapering|"Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (delayed tapering)."
11275832|NCT02763046|OG001|Outcome|Secukinumab - Early NSAID Tapering|"Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind.~NSAID tapering allowed from Week 4 (early tapering)."
11275833|NCT02763046|OG002|Outcome|Placebo|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20).~NSAID tapering allowed from Week 4."
11275834|NCT02763046|OG003|Outcome|Secukinumab - Pooled|The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
11275835|NCT02763046|EG000|Reported Event|Secukinumab - Delayed NSAID Tapering - Treatment Period 1|"Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).~Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study."
11275836|NCT02763046|EG001|Reported Event|Secukinumab - Early NSAID Tapering - Treatment Period 1|"Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).~Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study."
10847419|NCT00283244|BG002|Baseline|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
10847420|NCT00283244|BG003|Baseline|Total|Total of all reporting groups
11275837|NCT02763046|EG002|Reported Event|Placebo - Treatment Period 1|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.~Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study."
11275838|NCT02763046|EG003|Reported Event|Secukinumab - Delayed NSAID Tapering - Treatment Period 2|"Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).~Treatment Period 2: from the day of injection at visit Week 16 onwards until study end."
11275839|NCT02763046|EG004|Reported Event|Secukinumab - Early NSAID Tapering - Treatment Period 2|"Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).~Treatment Period 2: from the day of injection at visit Week 16 onwards until study end."
11275840|NCT02763046|EG005|Reported Event|Placebo - Treatment Period 2|"Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.~Treatment Period 2: from the day of injection at visit Week 16 onwards until study end."
11275841|NCT02763124|BG000|Baseline|Verion-LenSx|"The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.~Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions"
11275842|NCT02763124|FG000|Participant Flow|Verion-LenSx|"The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.~Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions"
11275843|NCT02763124|OG000|Outcome|Verion-LenSx|"The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.~Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions"
11275844|NCT02763124|EG000|Reported Event|Verion-LenSx|"The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.~Verion-LenSx: The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions"
11275845|NCT02763215|BG000|Baseline|Total|Participants in this study were not treated with any investigational products, but with SoC medications, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
11275846|NCT02763215|FG000|Participant Flow|Total|Participants in this study were not treated with any investigational products, but with standard of care (SoC) medications, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
11275847|NCT02763215|OG000|Outcome|Total|Participants in this study were not treated with any investigational products, but with SoC medications, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
11275848|NCT02763215|EG000|Reported Event|Total|Participants in this study were not treated with any investigational products, but with SoC medications, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
11275849|NCT02763254|BG000|Baseline|Baltaleucel-T|"Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.~baltaleucel-T: Autologous EBV-specific T cells"
11275850|NCT02763254|FG000|Participant Flow|Baltaleucel-T|"Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.~baltaleucel-T: Autologous EBV-specific T cells"
11275851|NCT02763254|OG000|Outcome|Balteleucel-T|"Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.~balteleucel-T: Autologous EBV-specific T cells"
11275852|NCT02763254|EG000|Reported Event|Baltaleucel-T|"Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.~baltaleucel-T: Autologous EBV-specific T cells"
11275853|NCT02763566|BG000|Baseline|Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)|Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.
11275854|NCT02763566|BG001|Baseline|Placebo + NSAI|Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.
11275855|NCT02763566|BG002|Baseline|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275856|NCT02763566|BG003|Baseline|Placebo + Fulvestrant|Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275857|NCT02763566|BG004|Baseline|Total|Total of all reporting groups
11275858|NCT02763566|FG000|Participant Flow|Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)|Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.
11275859|NCT02763566|FG001|Participant Flow|Placebo + NSAI|Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.
11275860|NCT02763566|FG002|Participant Flow|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275861|NCT02763566|FG003|Participant Flow|Placebo + Fulvestrant|Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275862|NCT02763566|OG000|Outcome|Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)|Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.
11275863|NCT02763566|OG001|Outcome|Placebo + NSAI|Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.
10820360|NCT00057577|BG000|Baseline|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
11275864|NCT02763566|OG000|Outcome|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275865|NCT02763566|OG001|Outcome|Placebo + Fulvestrant|Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275866|NCT02763566|OG002|Outcome|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275867|NCT02763566|OG003|Outcome|Placebo + Fulvestrant|Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275868|NCT02763566|OG001|Outcome|Placebo + NSAI|Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.
11275869|NCT02763566|OG001|Outcome|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275870|NCT02763566|EG000|Reported Event|Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)|Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.
11275871|NCT02763566|EG001|Reported Event|Placebo + NSAI|Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.
11275872|NCT02763566|EG002|Reported Event|Abemaciclib + Fulvestrant|Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275873|NCT02763566|EG003|Reported Event|Placebo + Fulvestrant|Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
11275874|NCT02763644|BG000|Baseline|LFG316 Plus Standard of Care (SoC)|LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)
11275875|NCT02763644|BG001|Baseline|All SoC First|Standard of Care then LFG316 plus SoC
11275876|NCT02763644|BG002|Baseline|Total|Total of all reporting groups
11275877|NCT02763644|FG000|Participant Flow|LFG316 Plus Standard of Care (SoC)|LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)
11275878|NCT02763644|FG001|Participant Flow|All SoC First|Standard of Care then LFG316 plus SoC
11275879|NCT02763644|OG000|Outcome|LFG316 Plus Standard of Care (SoC)|LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)
10970415|NCT00910624|OG000|Outcome|BOC + PEG/RBV: Prior Null Responders|"Participants who achieved null response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970416|NCT00910624|OG001|Outcome|BOC + PEG/RBV: Prior Partial Responders|"Participants who achieved partial response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
10970417|NCT00910624|OG002|Outcome|BOC + PEG/RBV: Prior Relapsers|"Participants who achieved prior relapse (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up."
11275880|NCT02763644|OG001|Outcome|All SoC First|Standard of Care then LFG316 plus SoC
11275881|NCT02763644|EG000|Reported Event|LFG316 Plus Standard of Care (SoC)|LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)
11275882|NCT02763644|EG001|Reported Event|Standard of Care SoC|Standard of Care (SoC)
11275883|NCT02763644|EG002|Reported Event|SoC Then LFG316|SoC then LFG316
11275884|NCT02763644|EG003|Reported Event|All SoC First|Standard of Care then LFG316 plus SoC
11275885|NCT02763826|BG000|Baseline|1 mA Bihemispheric tDCS|Participants received 1 mA Bihemispheric tDCS
11275886|NCT02763826|BG001|Baseline|2 mA Bihemispheric tDCS|Participants received 2 mA Bihemispheric tDCS
11275887|NCT02763826|BG002|Baseline|2.5 mA Bihemispheric tDCS|Participants received 2.5 mA Bihemispheric tDCS
11275888|NCT02763826|BG003|Baseline|3 mA Bihemispheric tDCS|Participants received 3 mA Bihemispheric tDCS
11275889|NCT02763826|BG004|Baseline|3.5 mA Bihemispheric tDCS|Participants received 3.5 mA Bihemispheric tDCS
11275890|NCT02763826|BG005|Baseline|4 mA Bihemispheric tDCS|Participants received 4 mA Bihemispheric tDCS
11275891|NCT02763826|BG006|Baseline|Crossover - 4mA Bihemisphere tDCS and 4 mA Anodal tDCS and 4mA Cathodal tDCS|Stroke subjects will each receive one of three stimulation montages
11275892|NCT02763826|BG007|Baseline|Total|Total of all reporting groups
11275893|NCT02763826|FG000|Participant Flow|1 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 1 mA with bihemispheric montage
11275894|NCT02763826|FG001|Participant Flow|2 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 2 mA with bihemispheric montage
11275895|NCT02763826|FG002|Participant Flow|2.5 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 2.5 mA with bihemispheric montage
11275896|NCT02763826|FG003|Participant Flow|3 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 3 mA with bihemispheric montage
11275897|NCT02763826|FG004|Participant Flow|3.5 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 3.5 mA with bihemispheric montage
11275898|NCT02763826|FG005|Participant Flow|4 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 4 mA with bihemispheric montage
11275899|NCT02763826|FG006|Participant Flow|4 mA Anodal tDCS|Subjects will get tDCS at a current of 4 mA with anodal montage
11275900|NCT02763826|FG007|Participant Flow|4 mA Cathodal tDCS|Subjects will get tDCS at a current of 4 mA with cathodal montage
11275901|NCT02763826|OG000|Outcome|1 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 1 mA with bihemispheric montage
11275902|NCT02763826|OG001|Outcome|2 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 2 mA with bihemispheric montage
11275903|NCT02763826|OG002|Outcome|2.5 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 2.5 mA with bihemispheric montage
11275904|NCT02763826|OG003|Outcome|3 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 3 mA with bihemispheric montage
11275905|NCT02763826|OG004|Outcome|3.5 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 3.5 mA with bihemispheric montage
11275906|NCT02763826|OG005|Outcome|4 mA Bihemispheric tDCS|Subjects will get tDCS at a current of 4 mA with bihemispheric montage
11275907|NCT02763826|OG006|Outcome|4 mA Anodal tDCS|Subjects will get tDCS at a current of 4 mA with anodal montage
11275908|NCT02763826|OG007|Outcome|4 mA Cathodal tDCS|Subjects will get tDCS at a current of 4 mA with cathodal montage
11275909|NCT02763826|EG000|Reported Event|1 mA Bihemispheric tDCS|Subjects will receive tDCS at 1 mA with bihemispheric montage
11275910|NCT02763826|EG001|Reported Event|2 mA Bihemispheric tDCS|Subjects will receive tDCS at 2 mA with bihemispheric montage
11275911|NCT02763826|EG002|Reported Event|2.5 mA Bihemispheric tDCS|Subjects will receive tDCS at 2.5 mA with bihemispheric montage
10820361|NCT00057577|BG001|Baseline|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820362|NCT00057577|BG002|Baseline|Total|Total of all reporting groups
10820363|NCT00057577|FG000|Participant Flow|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820364|NCT00057577|FG001|Participant Flow|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820365|NCT00057577|OG000|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820366|NCT00057577|OG001|Outcome|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10847421|NCT00283244|FG000|Participant Flow|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
11275912|NCT02763826|EG003|Reported Event|3 mA Bihemispheric tDCS|Subjects will receive tDCS at 3.0 mA with bihemispheric montage
11275913|NCT02763826|EG004|Reported Event|3.5 mA Bihemispheric tDCS|Subjects will receive tDCS at 3.5 mA with bihemispheric montage
11275914|NCT02763826|EG005|Reported Event|4 mA Bihemispheric tDCS|Subjects will receive tDCS at 4 mA with bihemispheric montage
11275915|NCT02763826|EG006|Reported Event|4 mA Anodal tDCS|Subjects will receive tDCS at 4 mA with anodal montage
11275916|NCT02763826|EG007|Reported Event|4 mA Cathodal tDCS|Subjects will receive tDCS at 4 mA with cathodal montage
11275917|NCT02763865|BG000|Baseline|Active|active tms
11275918|NCT02763865|BG001|Baseline|Sham|sham tms
11275919|NCT02763865|BG002|Baseline|Total|Total of all reporting groups
11275920|NCT02763865|FG000|Participant Flow|Active|Active pre-SMA rTMS
11275921|NCT02763865|FG001|Participant Flow|Sham|sham tms
11275922|NCT02763865|OG000|Outcome|Active|
11275923|NCT02763865|OG001|Outcome|Sham|
11275924|NCT02763865|OG000|Outcome|Active Pre-SMA rTMS|
11275925|NCT02763865|OG001|Outcome|Sham Pre-SMA rTMS|"The intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham).~MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil: Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total.~Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output.~eSHAM system: implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)"
11337663|NCT03590613|FG002|Participant Flow|Treatment Sequence C: 60mg TID/ 120mg TID/ PBO TID/ 240mg TID|Participants in this arm received GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, PBO TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 and placebo was administered at 0 hour (starting dose), 7 hours (second dose) and 14 hours (third dose) on Day 1 in each TP. Participants had fasted overnight for 8 hours before first dose. Each TP was followed by a washout period of at least 7 days, for each participant.
11275926|NCT02763865|EG000|Reported Event|Active Pre-SMA rTMS|"The intervention to be administered is the MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil l to administer active rTMS at 1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Two Thymapad Stimulus Electrodes will be placed in the appropriate position during active rTMS administration.This intervention method will be used for all 15 treatment sessions (20 minutes/session).~MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil: Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total.~Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output."
11275927|NCT02763865|EG001|Reported Event|Sham Pre-SMA rTMS|"The intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham).~MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil: Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total.~Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output.~eSHAM system: implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)"
11275928|NCT02764151|BG000|Baseline|PF-06840003 125 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.
11275929|NCT02764151|BG001|Baseline|PF-06840003 250 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.
11275930|NCT02764151|BG002|Baseline|PF-06840003 250 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.
11275931|NCT02764151|BG003|Baseline|PF-06840003 500 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.
11275932|NCT02764151|BG004|Baseline|Total|Total of all reporting groups
11275933|NCT02764151|FG000|Participant Flow|PF-06840003 125 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.
11275934|NCT02764151|FG001|Participant Flow|PF-06840003 250 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.
11275935|NCT02764151|FG002|Participant Flow|PF-06840003 250 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.
11275936|NCT02764151|FG003|Participant Flow|PF-06840003 500 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.
11275937|NCT02764151|OG000|Outcome|PF-06840003 125 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.
11275938|NCT02764151|OG001|Outcome|PF-06840003 250 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.
11275939|NCT02764151|OG002|Outcome|PF-06840003 250 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.
11275940|NCT02764151|OG003|Outcome|PF-06840003 500 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.
11275941|NCT02764151|EG000|Reported Event|PF-06840003 125 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.
11275942|NCT02764151|EG001|Reported Event|PF-06840003 250 MG QD|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.
11275943|NCT02764151|EG002|Reported Event|PF-06840003 250 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.
11275944|NCT02764151|EG003|Reported Event|PF-06840003 500 MG BID|PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.
11275945|NCT02764164|BG000|Baseline|Intervention Active tDCS|"Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label~Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations."
11275946|NCT02764164|FG000|Participant Flow|Intervention Active tDCS|"Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label~Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations."
11275947|NCT02764164|OG000|Outcome|Intervention Active tDCS|"Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label~Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations."
11275948|NCT02764164|EG000|Reported Event|Intervention Active tDCS|"Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label~Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations."
11275949|NCT02764190|BG000|Baseline|Experimental: I-ACT With Check Yourself|Adolescents completed Check Yourself which delivered personalized, motivational feedback to them on their health behaviors prior to their primary care appointment. Primary care providers received training (I-ACT) and the Check Yourself summary report of health risk behaviors before the adolescent's appointment. I-ACT consisted of online, interactive training in adolescent-preferred communication methods and motivational interviewing, with booster sessions and feedback reports to reinforce new skills.
11275950|NCT02764190|BG001|Baseline|No Intervention: Usual Care|In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors.
11275951|NCT02764190|BG002|Baseline|Total|Total of all reporting groups
11275952|NCT02764190|FG000|Participant Flow|Experimental: I-ACT With Check Yourself|Adolescents completed Check Yourself which delivered personalized, motivational feedback to them on their health behaviors prior to their primary care appointment. Primary care providers received training (I-ACT) and the Check Yourself summary report of health risk behaviors before the adolescent's appointment. I-ACT consisted of online, interactive training in adolescent-preferred communication methods and motivational interviewing, with booster sessions and feedback reports to reinforce new skills.
11275953|NCT02764190|FG001|Participant Flow|No Intervention: Usual Care|In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors.
11275954|NCT02764190|OG000|Outcome|Experimental: I-ACT With Check Yourself|Adolescents completed Check Yourself which delivered personalized, motivational feedback to them on their health behaviors prior to their primary care appointment. Primary care providers received training (I-ACT) and the Check Yourself summary report of health risk behaviors before the adolescent's appointment. I-ACT consisted of online, interactive training in adolescent-preferred communication methods and motivational interviewing, with booster sessions and feedback reports to reinforce new skills.
11275955|NCT02764190|OG001|Outcome|No Intervention: Usual Care|In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors.
11275956|NCT02764190|EG000|Reported Event|Experimental: I-ACT With Check Yourself|Adolescents completed Check Yourself which delivered personalized, motivational feedback to them on their health behaviors prior to their primary care appointment. Primary care providers received training (I-ACT) and the Check Yourself summary report of health risk behaviors before the adolescent's appointment. I-ACT consisted of online, interactive training in adolescent-preferred communication methods and motivational interviewing, with booster sessions and feedback reports to reinforce new skills.
11275957|NCT02764190|EG001|Reported Event|No Intervention: Usual Care|In the usual care group, adolescents are asked to complete health risk screening on a computer. No personalized feedback is provided to adolescents and primary care providers do not receive I-ACT or the Check Yourself summary report of the adolescent's health risk behaviors.
11275958|NCT02764229|BG000|Baseline|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily
10847422|NCT00283244|FG001|Participant Flow|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
10847423|NCT00283244|FG002|Participant Flow|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
11275959|NCT02764229|FG000|Participant Flow|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily
11275960|NCT02764229|OG000|Outcome|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily
11275961|NCT02764229|EG000|Reported Event|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily
11275962|NCT02764320|BG000|Baseline|Discontinuation|"Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)~Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy"
11275963|NCT02764320|BG001|Baseline|Preventive Therapy Only|"Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)~Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)"
11275964|NCT02764320|BG002|Baseline|Total|Total of all reporting groups
11275965|NCT02764320|FG000|Participant Flow|Discontinuation|"Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)~Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy"
11275966|NCT02764320|FG001|Participant Flow|Preventive Therapy Only|"Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)~Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)"
11275967|NCT02764320|OG000|Outcome|Discontinuation|"Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)~Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy"
11275968|NCT02764320|OG001|Outcome|Preventive Therapy Only|"Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)~Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)"
11275969|NCT02764320|EG000|Reported Event|Discontinuation|"Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)~Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy"
11275970|NCT02764320|EG001|Reported Event|Preventive Therapy Only|"Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)~Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)"
11275971|NCT02764333|BG000|Baseline|Vaccine|"Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.~TPIV200~Durvalumab"
11275972|NCT02764333|FG000|Participant Flow|Vaccine|"Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.~TPIV200~Durvalumab"
11275973|NCT02764333|OG000|Outcome|Vaccine|"Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.~TPIV200~Durvalumab"
11275974|NCT02764333|EG000|Reported Event|Vaccine|"Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.~TPIV200~Durvalumab"
11275975|NCT02764385|BG000|Baseline|AAC Only|"This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275976|NCT02764385|BG001|Baseline|AAC + TMCP|"The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275977|NCT02764385|BG002|Baseline|Total|Total of all reporting groups
11275978|NCT02764385|FG000|Participant Flow|AAC Only|"This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275979|NCT02764385|FG001|Participant Flow|AAC + TMCP|"The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275980|NCT02764385|OG000|Outcome|AAC Only|"This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275981|NCT02764385|OG001|Outcome|AAC + TMCP|"The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275982|NCT02764385|EG000|Reported Event|AAC Only|"This is a system-based intervention that involves changes in the EHR regarding documenting tobacco assessment and the capability to order an eReferral to the Quitline. This system-based intervention also changes the role of the medical technical assistant.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275983|NCT02764385|EG001|Reported Event|AAC + TMCP|"The Teachable Moment Communication Process is a clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~Teachable Moment Communication Process: A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.~AAC: A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants"
11275984|NCT02764697|BG000|Baseline|H.P. Acthar Subcutaneous Gel Injection|"For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.~H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly"
11275985|NCT02764697|FG000|Participant Flow|H.P. Acthar Subcutaneous Gel Injection|"For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.~H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly"
11275986|NCT02764697|OG000|Outcome|H.P. Acthar Subcutaneous Gel Injection|"For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.~H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly"
11275987|NCT02764697|EG000|Reported Event|H.P. Acthar Subcutaneous Gel Injection|"For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.~H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly"
10820367|NCT00057577|OG001|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820368|NCT00057577|OG000|Outcome|Prior CBT + Meds Maintained|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and maintained on medications
10820369|NCT00057577|OG001|Outcome|Prior CBT + Meds Withdrawn|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and withdrawn from medications
11275988|NCT02764762|BG000|Baseline|Vedolizumab 300 mg (IV)+ Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)|In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
11275989|NCT02764762|FG000|Participant Flow|Vedolizumab 300 mg (IV)+ Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)|In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
11275990|NCT02764762|OG000|Outcome|Vedolizumab 300 mg (IV)+ Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)|In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
11275991|NCT02764762|EG000|Reported Event|Vedolizumab 300 mg (IV)+ Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)|In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34.
11275992|NCT02764775|BG000|Baseline|Headpod Utilization|"Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;~Headpod: Adaptive equipment to assist with active head movements"
11275993|NCT02764775|FG000|Participant Flow|Headpod Utilization|"Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use.~Headpod: Adaptive equipment to assist with active head movements"
11275994|NCT02764775|OG000|Outcome|Headpod Utilization|"Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use.~Headpod: Adaptive equipment to assist with active head movements"
11275995|NCT02764775|EG000|Reported Event|Headed Utilization|"Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;~Headpod: Adaptive equipment to assist with active head movements"
11275996|NCT02764970|BG000|Baseline|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
11275997|NCT02764970|BG001|Baseline|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
11275998|NCT02764970|BG002|Baseline|Total|Total of all reporting groups
11275999|NCT02764970|FG000|Participant Flow|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
11276000|NCT02764970|FG001|Participant Flow|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
11276001|NCT02764970|OG000|Outcome|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
11276002|NCT02764970|OG001|Outcome|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
11276003|NCT02764970|EG000|Reported Event|Ivabradine 7.5mg Orally|"patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram~Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol"
10820370|NCT00057577|OG002|Outcome|Prioir Meds Maintained|Patients who recovered on medication treatment were maintained on medications
10820371|NCT00057577|OG003|Outcome|Prior Meds Withdrawn|Patients who recovered on medication treatment were withdrawn from medications
11276004|NCT02764970|EG001|Reported Event|Bisoprolol|patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
11276005|NCT02765035|BG000|Baseline|C-Leg 3, Then C-Leg 4|"C-Leg 4: Microprocessor Controlled Knee~C-Leg 3: Microprocessor Controlled Knee"
11276006|NCT02765035|BG001|Baseline|C-Leg 4, Then C-Leg 3|"C-Leg 4: Microprocessor Controlled Knee~C-Leg 3: Microprocessor Controlled Knee"
11276007|NCT02765035|BG002|Baseline|Total|Total of all reporting groups
11276008|NCT02765035|FG000|Participant Flow|C-Leg 3, Then C-Leg 4|The participants were first fitted with C-Leg 3 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 4 and allowed to accommodate for 30 days after which they were assessed.
11276009|NCT02765035|FG001|Participant Flow|C-Leg 4, Then C-Leg 3|The participants were first fitted with C-Leg 4 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 3 and allowed to accommodate for 30 days after which they were assessed.
11276010|NCT02765035|OG000|Outcome|C-Leg 3|The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
11276011|NCT02765035|OG001|Outcome|C-Leg 4|The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
11276012|NCT02765035|OG000|Outcome|All Subjects|All subjects were ask which knee they preferred after having been fitted and acclimatized to each (C-Leg 3, C-Leg 4 and the NMPK)
11276013|NCT02765035|EG000|Reported Event|C-Leg 3|The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
11276014|NCT02765035|EG001|Reported Event|C-Leg 4|The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
11276015|NCT02765100|BG000|Baseline|Low CRP|CRP =/< 3
11276016|NCT02765100|BG001|Baseline|High CRP|CRP > 3
11276017|NCT02765100|BG002|Baseline|Total|Total of all reporting groups
11276018|NCT02765100|FG000|Participant Flow|Low CRP|patients with a baseline C-ReactiveProtein value =/< 3 treated with minocycline 200 mg/d
11276019|NCT02765100|FG001|Participant Flow|High CRP|patients with a baseline C-ReactiveProtein value >3 treated with minocycline 200 mg/d
11276020|NCT02765100|OG000|Outcome|Low CRP|patients with baseline CRP =/< 3
11276021|NCT02765100|OG001|Outcome|High CRP|patients with baseline CRP > 3
11276022|NCT02765100|EG000|Reported Event|Low CRP|CRP =/< 3
11276023|NCT02765100|EG001|Reported Event|High CRP|CRP > 3
11276024|NCT02765165|BG000|Baseline|Part 1a, Cohort 1|USL311, intravenous, once per week, 60 mg/m˄2, in 21-day cycles
11276025|NCT02765165|BG001|Baseline|Part 1a, Cohort 2|USL311, intravenous, once per week, 120 mg/m˄2, in 21-day cycles
11276026|NCT02765165|BG002|Baseline|Part 1a, Cohort 3,|USL311, intravenous, once per week, 180 mg/m˄2, in 21-day cycles
11276027|NCT02765165|BG003|Baseline|Part 1a, Cohort 4,|USL311, intravenous, once per week, 250 mg/m˄2, in 21-day cycles
11276028|NCT02765165|BG004|Baseline|Part 1b, Cohort 1|USL311, oral, daily, 40 mg, in 21-day cycles
11276029|NCT02765165|BG005|Baseline|Part 1b, Cohort 2|USL311, oral, daily, 80 mg, in 21-day cycles
11276030|NCT02765165|BG006|Baseline|Part 1b, Cohort 3|USL311, oral, daily, 160 mg, in 21-day cycles
11276031|NCT02765165|BG007|Baseline|Total|Total of all reporting groups
11276032|NCT02765165|FG000|Participant Flow|Part 1a, Cohort 1|USL311, intravenous, once per week, 60 mg/m˄2, in 21-day cycles
11276033|NCT02765165|FG001|Participant Flow|Part 1a, Cohort 2|USL311, intravenous, once per week, 120 mg/m˄2, in 21-day cycles
11276034|NCT02765165|FG002|Participant Flow|Part 1a, Cohort 3|USL311, intravenous, once per week, 180 mg/m˄2, in 21-day cycles
11276035|NCT02765165|FG003|Participant Flow|Part 1a, Cohort 4|USL311, intravenous, once per week, 250 mg/m˄2, in 21-day cycles
11276036|NCT02765165|FG004|Participant Flow|Part 1b, Cohort 1|USL311, oral, once per day, 40 mg, in 21-day cycles
11276037|NCT02765165|FG005|Participant Flow|Part 1b, Cohort 2|USL311, oral, once per day, 80 mg, in 21-day cycles
11276038|NCT02765165|FG006|Participant Flow|Part 1b, Cohort 3|USL311, oral, once per day, 160 mg, in 21-day cycles
11276039|NCT02765165|OG000|Outcome|Part 1a, Dose-escalation, All Oral Cohorts|USL311, intravenous, once per week, starting at 60 mg/m˄2, in 21-day cycles
11276040|NCT02765165|OG000|Outcome|Part 1b, Dose-escalation, All Oral Cohorts|USL311, oral, once per day, starting at 40 mg, in 21 day cycles
11276041|NCT02765165|OG000|Outcome|Part 1, Dose-escalation, All Cohorts|USL311, intravenous once per week, starting at 60 mg/m˄2, or oral once per day, starting at 40 mg, in 21-day cycles
11276042|NCT02765165|OG000|Outcome|Part 1a, Cohort 1|USL311, intravenous, once per week over 2 hours, 60 mg/m˄2, in 21-day cycles
11092305|NCT01539083|FG000|Participant Flow|Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
11276043|NCT02765165|OG001|Outcome|Part 1a, Cohort 2|USL311, intravenous, once per week over 2 hours, 120 mg/m˄2, in 21-day cycles
11276044|NCT02765165|OG002|Outcome|Part 1a, Cohort 3a|USL311, intravenous, once per week over 2 hours, 180 mg/m˄2, in 21-day cycles
11276045|NCT02765165|OG003|Outcome|Part 1a, Cohort 3b|USL311, intravenous, once per week over 4 hours, 180 mg/m˄2, in 21-day cycles
11276046|NCT02765165|OG004|Outcome|Part 1a, Cohort 4|USL311, intravenous, once per week over 4 hours, 250 mg/m˄2, in 21-day cycles
11276047|NCT02765165|OG005|Outcome|Part 1b, Cohort 1|USL311, oral, once per day, 40 mg, in 21-day cycles
11276048|NCT02765165|OG006|Outcome|Part 1b, Cohort 2|USL311, oral, once per day, 80 mg, in 21-day cycles
11276049|NCT02765165|OG007|Outcome|Part 1b, Cohort 3|USL311, oral, once per day, 160 mg, in 21-day cycles
11276050|NCT02765165|EG000|Reported Event|Part 1a, Cohort 1|USL311, intravenous, once per week, at 60 mg/m˄2, in 21-day cycles
11276051|NCT02765165|EG001|Reported Event|Part 1a, Cohort 2|USL311, intravenous, once per week, at 120 mg/m˄2, in 21-day cycles
11276052|NCT02765165|EG002|Reported Event|Part 1a, Cohort 3|USL311, intravenous, once per week, at 180 mg/m˄2, in 21-day cycles
11276053|NCT02765165|EG003|Reported Event|Part 1a, Cohort 4|USL311, intravenous, once per week, at 250 mg/m˄2, in 21-day cycles
11276054|NCT02765165|EG004|Reported Event|Part 1b, Cohort 1|USL311, oral, once per day, 40 mg, in 21-day cycles
11276055|NCT02765165|EG005|Reported Event|Part 1b, Cohort 2|USL311, oral, once per day, 80 mg, in 21-day cycles
11276056|NCT02765165|EG006|Reported Event|Part 1b, Cohort 3|USL311, oral, once per day, 160 mg, in 21-day cycles
11276057|NCT02765256|BG000|Baseline|Fluconazole|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole: 400mg orally once daily (Day 1-14)~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3)."
11276058|NCT02765256|BG001|Baseline|Placebo|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole placebo: Once daily"
11276059|NCT02765256|BG002|Baseline|Total|Total of all reporting groups
11276060|NCT02765256|FG000|Participant Flow|Fluconazole|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole: 400mg orally once daily (Day 1-14)~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3)."
11276061|NCT02765256|FG001|Participant Flow|Placebo|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole placebo: Once daily"
10847424|NCT00283244|OG000|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
10847425|NCT00283244|OG001|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21
11276062|NCT02765256|OG000|Outcome|Fluconazole|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole: 400mg orally once daily (Day 1-14)~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3)."
11276063|NCT02765256|OG001|Outcome|Placebo|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole placebo: Once daily"
11276064|NCT02765256|EG000|Reported Event|Fluconazole|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole: 400mg orally once daily (Day 1-14)~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3)."
11276065|NCT02765256|EG001|Reported Event|Placebo|"Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Vancomycin: 500mg oral suspension 4 times daily (Day 1-14)~Neomycin: neomycin 1000 mg orally three times daily (Days 1-3)~Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)~Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2~Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).~Fluconazole placebo: Once daily"
11276066|NCT02765269|BG000|Baseline|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
11276067|NCT02765269|BG001|Baseline|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
11276068|NCT02765269|BG002|Baseline|Total|Total of all reporting groups
11276069|NCT02765269|FG000|Participant Flow|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
11276070|NCT02765269|FG001|Participant Flow|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
11276071|NCT02765269|OG000|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
11276072|NCT02765269|OG001|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
10847426|NCT00283244|OG002|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
10847427|NCT00283244|OG001|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
10847428|NCT00283244|EG000|Reported Event|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
11276073|NCT02765269|EG000|Reported Event|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
11276074|NCT02765269|EG001|Reported Event|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
11276075|NCT02765490|BG000|Baseline|Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
11276076|NCT02765490|BG001|Baseline|Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
11276077|NCT02765490|BG002|Baseline|Total|Total of all reporting groups
11276078|NCT02765490|FG000|Participant Flow|Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
11276079|NCT02765490|FG001|Participant Flow|Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
11276080|NCT02765490|OG000|Outcome|Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
11276081|NCT02765490|OG001|Outcome|Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
11276082|NCT02765490|EG000|Reported Event|Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
11276083|NCT02765490|EG001|Reported Event|Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks|Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
10847429|NCT00283244|EG001|Reported Event|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
10847430|NCT00283244|EG002|Reported Event|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
10847431|NCT00283283|BG000|Baseline|Full Dose, Age 18-49|Previously Vaccinated Subjects Receiving Full Dose Aged 18-49 Years
11276084|NCT02766023|BG000|Baseline|LACTIN-V|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
11276085|NCT02766023|BG001|Baseline|Placebo|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
11276086|NCT02766023|BG002|Baseline|Total|Total of all reporting groups
11276087|NCT02766023|FG000|Participant Flow|LACTIN-V|"Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive LACTIN-V 2x10^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks. N=152~Lactobacillus crispatus CTV-05: LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Participants receive 2x10^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.~Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days"
11276088|NCT02766023|FG001|Participant Flow|Placebo|"Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive placebo applied vaginally for 5 days then twice weekly for 10 weeks. N=76~Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days~Placebo: Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks."
11276089|NCT02766023|OG000|Outcome|LACTIN-V|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
11276090|NCT02766023|OG001|Outcome|Placebo|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
11276091|NCT02766023|EG000|Reported Event|LACTIN-V|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
11276092|NCT02766023|EG001|Reported Event|Placebo|5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
11276093|NCT02766088|BG000|Baseline|Total Group|Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
11276094|NCT02766088|FG000|Participant Flow|Total Group|Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
11276095|NCT02766088|OG000|Outcome|Total Group|Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
11276096|NCT02766088|EG000|Reported Event|Total Group|Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
11276097|NCT02766244|BG000|Baseline|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276098|NCT02766244|FG000|Participant Flow|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276099|NCT02766244|OG000|Outcome|Patient 1 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276100|NCT02766244|OG001|Outcome|Patient 1 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276101|NCT02766244|OG002|Outcome|Patient 2 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276102|NCT02766244|OG003|Outcome|Patient 2 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276103|NCT02766244|OG004|Outcome|Patient 3 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276104|NCT02766244|OG005|Outcome|Patient 3 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276105|NCT02766244|EG000|Reported Event|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
11276106|NCT02766283|BG000|Baseline|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
11276107|NCT02766283|FG000|Participant Flow|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: thyroid-stimulating hormone (TSH) levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
10847432|NCT00283283|BG001|Baseline|Half Dose, Age 18-49|Previously Vaccinated Subjects Receiving Half Dose Aged 18-49 Years
11276108|NCT02766283|OG000|Outcome|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
11276109|NCT02766283|OG000|Outcome|No Hypothyroidism Indication|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
11276110|NCT02766283|OG001|Outcome|Hypothyroidism Indication|Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
11276111|NCT02766283|OG000|Outcome|Final Cohort|Participants without potential hypothyroidism detected during the one-year follow up period (828 person years)
11276112|NCT02766283|OG000|Outcome|Probable Iodine-induced Hypothyroidism|Included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
11276113|NCT02766283|EG000|Reported Event|Iodine Contrast Agent|The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
11276114|NCT02766374|BG000|Baseline|HRV Biofeedback|Biofeedback to maximaize heart rate variability. Procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109.
11276115|NCT02766374|BG001|Baseline|EEG+ Biofeedback|Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24.
11276116|NCT02766374|BG002|Baseline|Total|Total of all reporting groups
11276117|NCT02766374|FG000|Participant Flow|HRV Biofeedback|"During the first training session, we will measure heart rate variability (HRV) amplitude while the patient breathes for two minutes at a frequency ranging between 4.5-6.5 breaths/min, providing a pacing stimulus for this purpose. In subsequent sessions, the individual will be given personal HRV biofeedback, and instructed to increase the amplitude of heart rate oscillations, using a cardiotachometer tracing and frequency peaks as biofeedback stimuli, while avoiding hyperventilation symptoms, by breathing more shallowly, although slowly, at whatever frequency produces maximum-amplitude HRV. This procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109."
11276118|NCT02766374|FG001|Participant Flow|EEG+ Biofeedback|Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24.
11276119|NCT02766374|OG000|Outcome|HRV-BF|"During the first training session, we will measure heart rate variability biofeedback amplitude while the patient breathes for two minutes at a frequency ranging between 4.5-6.5 breaths/min, providing a pacing stimulus for this purpose. In subsequent sessions, the individual will be given personal HRV biofeedback, and instructed to increase the amplitude of heart rate oscillations, using a cardiotachometer tracing and frequency peaks as biofeedback stimuli, while avoiding hyperventilation symptoms, by breathing more shallowly, although slowly, at whatever frequency produces maximum-amplitude HRV."
11276120|NCT02766374|OG001|Outcome|PBO-BF|"The method consists of: 1) receiving EEG/music biofeedback (actually, a mildly relaxing intervention, using EEG biofeedback to alternately increase and decrease frontal/occipital EEG alpha rhythms while listening to relaxing music), and 2) listening to recorded sounds of nature along with relaxing music with instructions to maintain a condition of relaxed alertness. For home training, subjects will be given placebo StressEraser programmed to give feedback to maintain their breathing at baseline rate."
11276121|NCT02766374|EG000|Reported Event|HRV Biofeedback|Biofeedback to maximaize heart rate variability. Procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109.
11276122|NCT02766374|EG001|Reported Event|EEG+ Biofeedback|Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24.
11276123|NCT02766400|BG000|Baseline|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
11286902|NCT02895347|OG000|Outcome|Experimental Group|"Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then they were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until they reached proficiency (91%) in all 4 activities. 4. Participants were asked to return where they were filmed and timed completing a suturing activity on the porcine model.~Surgical Simulation Practice Modules: The surgical simulation practice modules simulate surgical settings for suturing."
10847433|NCT00283283|BG002|Baseline|Full Dose, Age 50-64|Previously Vaccinated Subjects Receiving Full Dose Aged 50-64 Years
11276124|NCT02766400|BG001|Baseline|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
11276125|NCT02766400|BG002|Baseline|Total|Total of all reporting groups
11276126|NCT02766400|FG000|Participant Flow|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
11276127|NCT02766400|FG001|Participant Flow|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
11276128|NCT02766400|OG000|Outcome|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
11276129|NCT02766400|OG001|Outcome|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
11276130|NCT02766400|EG000|Reported Event|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
11276131|NCT02766400|EG001|Reported Event|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
11276132|NCT02766517|BG000|Baseline|Placebo|Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276133|NCT02766517|BG001|Baseline|120 mg Galcanezumab|Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276134|NCT02766517|BG002|Baseline|300 mg Galcanezumab|Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276135|NCT02766517|BG003|Baseline|Total|Total of all reporting groups
11276136|NCT02766517|FG000|Participant Flow|Placebo|Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 microgram (mcg) capsaicin solution and vehicle topically in current study.
11276137|NCT02766517|FG001|Participant Flow|120 mg Galcanezumab|Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
10847434|NCT00283283|BG003|Baseline|Half Dose, Age 50-64|Previously Vaccinated Subjects Receiving Half Dose Aged 50-64 Years
11276138|NCT02766517|FG002|Participant Flow|300 mg Galcanezumab|Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276139|NCT02766517|OG000|Outcome|Placebo|Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276140|NCT02766517|OG001|Outcome|120 mg Galcanezumab|Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276141|NCT02766517|OG002|Outcome|300 mg Galcanezumab|Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276142|NCT02766517|EG000|Reported Event|Placebo|Participants who received placebo in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276143|NCT02766517|EG001|Reported Event|120 mg Galcanezumab|Participants who received 120 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11276144|NCT02766517|EG002|Reported Event|300 mg Galcanezumab|Participants who received 300 mg galcanezumab (LY2951742) in previous study I5Q-MC-CGAB administered with 1000 mcg capsaicin solution and vehicle topically in current study.
11286903|NCT02895347|EG000|Reported Event|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
11286904|NCT02895347|EG001|Reported Event|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
11286905|NCT02895360|BG000|Baseline|30 mg/m² Cohort|BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
11286906|NCT02895360|BG001|Baseline|45 mg/m² Cohort|BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
11286907|NCT02895360|BG002|Baseline|70 mg/m² Cohort|BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
11286908|NCT02895360|BG003|Baseline|90 mg/m² Cohort|BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
11286909|NCT02895360|BG004|Baseline|Phase 2a - Ovarian Cancer Cohort|BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
11286910|NCT02895360|BG005|Baseline|Phase 2a - Recurrent Glioblastoma Cohort|BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
11286911|NCT02895360|BG006|Baseline|Total|Total of all reporting groups
11286912|NCT02895360|FG000|Participant Flow|Phase 1 - 30 mg/m² Cohort|BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
11286913|NCT02895360|FG001|Participant Flow|Phase 1 - 45 mg/m² Cohort|BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
11286914|NCT02895360|FG002|Participant Flow|Phase 1 - 70 mg/m² Cohort|BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
11286915|NCT02895360|FG003|Participant Flow|Phase 1 - 90 mg/m² Cohort|BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
11286916|NCT02895360|FG004|Participant Flow|Phase 2a - Ovarian Cancer Cohort|"BAL101553 at 70 mg/m² (MTD)~BAL101553 as 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11286917|NCT02895360|FG005|Participant Flow|Phase 2a - Recurrent Glioblastoma Cohort|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
10847435|NCT00283283|BG004|Baseline|Total|Total of all reporting groups
10847436|NCT00283283|FG000|Participant Flow|Full Dose, Age 18-49|Subjects age 18-49 receiving full dose
10847437|NCT00283283|FG001|Participant Flow|Half Dose, Age 18-49|Subjects age 18-49 receiving half dose
10847438|NCT00283283|FG002|Participant Flow|Full Dose, Age 50-64|Subjects age 50-64 receiving full dose
11286918|NCT02895360|OG000|Outcome|MTD-determining Population in Phase 1|All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
11286919|NCT02895360|OG000|Outcome|Phase 1 - 30 mg/m² Cohort|BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
11286920|NCT02895360|OG001|Outcome|Phase 1 - 45 mg/m² Cohort|BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
11276145|NCT02766608|BG000|Baseline|BFF MDI 320/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11276146|NCT02766608|BG001|Baseline|BFF MDI 160/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
11276147|NCT02766608|BG002|Baseline|FF MDI 9.6 μg|Formoterol Fumarate Metered Dose Inhalation 9.6 μg
11276148|NCT02766608|BG003|Baseline|BD MDI 320 μg|Budesonide Metered Dose Inhalation 320 μg
11276149|NCT02766608|BG004|Baseline|Symbicort TBH 400/12 μg|Symbicort Turbuhaler 400/12 μg
11276150|NCT02766608|BG005|Baseline|Total|Total of all reporting groups
11276151|NCT02766608|FG000|Participant Flow|BFF MDI 320/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11276152|NCT02766608|FG001|Participant Flow|BFF MDI 160/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
11276153|NCT02766608|FG002|Participant Flow|FF MDI 9.6 μg|Formoterol Fumarate Metered Dose Inhalation 9.6 μg
11276154|NCT02766608|FG003|Participant Flow|BD MDI 320 μg|Budesonide Metered Dose Inhalation 320 μg
11276155|NCT02766608|FG004|Participant Flow|Symbicort TBH 400/12 μg|Symbicort Turbuhaler 400/12 μg
11276156|NCT02766608|OG000|Outcome|BFF MDI 320/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11276157|NCT02766608|OG001|Outcome|BFF MDI 160/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
11276158|NCT02766608|OG002|Outcome|FF MDI 9.6 μg|Formoterol Fumarate Metered Dose Inhalation 9.6 μg
11276159|NCT02766608|OG002|Outcome|FF MDI 9.6 ug|Formoterol Fumarate Metered Dose Inhalation 9.6 μg
11276160|NCT02766608|OG003|Outcome|BD MDI 320 ug|Budesonide Metered Dose Inhalation 320 μg
11276161|NCT02766608|OG004|Outcome|Symbicort TBH 400/12 ug|Symbicort Turbuhaler 400/12 ug
11276162|NCT02766608|OG003|Outcome|BD MDI 320 μg|Budesonide Metered Dose Inhalation 320 μg
11276163|NCT02766608|OG004|Outcome|Symbicort TBH 400/12 μg|Symbicort Turbuhaler 400/12 μg
11276164|NCT02766608|EG000|Reported Event|BFF MDI 320/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
11276165|NCT02766608|EG001|Reported Event|BFF MDI 160/9.6 μg|Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
11276166|NCT02766608|EG002|Reported Event|FF MDI 9.6 μg|Formoterol Fumarate Metered Dose Inhalation 9.6 μg
11276167|NCT02766608|EG003|Reported Event|BD MDI 320 μg|Budesonide Metered Dose Inhalation 320 μg
11276168|NCT02766608|EG004|Reported Event|Symbicort TBH 400/12 μg|Symbicort Turbuhaler 400/12 μg
10847439|NCT00283283|FG003|Participant Flow|Half Dose, Age 50-64|Subjects age 50-64 receiving half dose
11276169|NCT02766673|BG000|Baseline|Overall Study|This was a crossover study therefore all patients were scheduled to receive all 3 treatment groups. Enrollment demographics will be the same for all groups.
11276170|NCT02766673|FG000|Participant Flow|Treatment Sequence A|"Treatment group 1: Placebo (0.9% sterile saline) every 4 hours for 24 hours~6 hour washout phase~Treatment group 2: 1.25mg Albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 3: 2.5 mg Albuterol every 4 hours for 24 hours"
11276171|NCT02766673|FG001|Participant Flow|Treatment Sequence B|"Treatment group 1: Placebo (0.9% sterile saline) every 4 hours for 24 hours~6 hour washout phase~Treatment group 2: 2.5mg Albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 3: 1.25mg Albuterol every 4 hours for 24 hours"
11276172|NCT02766673|FG002|Participant Flow|Treatment Sequence C|"Treatment Group 1: 1.25 mg Albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 2: Placebo (0.9% sterile saline) every 4 hours for 24 hours~6 hour washout phase~Treatment group 3: 2.5mg albuterol every 4 hours for 24 hours"
11276173|NCT02766673|FG003|Participant Flow|Treatment Sequence D|"Treatment Group 1: 1.25 mg Albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 2: 2.5mg albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 3: Placebo (0.9% sterile saline) every 4 hours for 24 hours"
11276174|NCT02766673|FG004|Participant Flow|Treatment Sequence E|"Treatment group 1: 2.5mg albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 2: Placebo (0.9% sterile saline) every 4 hours for 24 hours~6 hour washout phase~Treatment Group 3: 1.25 mg Albuterol every 4 hours for 24 hours"
11276175|NCT02766673|FG005|Participant Flow|Treatment Sequence F|"Treatment group 1: 2.5mg albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment Group 2: 1.25 mg Albuterol every 4 hours for 24 hours~6 hour washout phase~Treatment group 3: Placebo (0.9% sterile saline) every 4 hours for 24 hours"
11276176|NCT02766673|OG000|Outcome|Full Dose Albuterol Sulfate|"2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator~Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276177|NCT02766673|OG001|Outcome|Half Dose Albuterol Sulfate|"1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator~Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276178|NCT02766673|OG002|Outcome|Sterile Saline|"3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator~Sterile Saline: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276179|NCT02766673|EG000|Reported Event|Full Dose Albuterol|"2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator~Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276180|NCT02766673|EG001|Reported Event|Half Dose Albuterol|"1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator~Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276181|NCT02766673|EG002|Reported Event|Sterile Saline|"3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator~Sterile Saline: Subjects will receive a dose of study medication every 4 hours for 24 total hours"
11276182|NCT02766777|BG000|Baseline|Lubiprostone|Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
11276183|NCT02766777|FG000|Participant Flow|Lubiprostone|Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
10847440|NCT00283283|OG000|Outcome|Age 18 - 49, Full Dose|"0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
11276184|NCT02766777|OG000|Outcome|Lubiprostone|Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
11276185|NCT02766777|EG000|Reported Event|Lubiprostone|Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
11276186|NCT02766907|BG000|Baseline|Study|"prospective arm receiving cryopreserved amniotic membrane~cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD"
11276187|NCT02766907|BG001|Baseline|Control|Retrospective review of debridement without cryopreserved amniotic membrane
11276188|NCT02766907|BG002|Baseline|Total|Total of all reporting groups
11276189|NCT02766907|FG000|Participant Flow|Control|Retrospective review of debridement without cryopreserved amniotic membrane
11276190|NCT02766907|FG001|Participant Flow|Study|"prospective arm receiving cryopreserved amniotic membrane~cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for epithelial basement membrane dystrophy (EBMD)"
11276191|NCT02766907|OG000|Outcome|Study|"prospective arm receiving cryopreserved amniotic membrane~cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD"
11276192|NCT02766907|OG001|Outcome|Control|Retrospective review of debridement without cryopreserved amniotic membrane
11276193|NCT02766907|EG000|Reported Event|Study|"prospective arm receiving cryopreserved amniotic membrane~cryopreserved amniotic membrane: placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD"
11276194|NCT02766907|EG001|Reported Event|Control|Retrospective review of debridement without cryopreserved amniotic membrane
11276195|NCT02767011|BG000|Baseline|THEM|Intervention Group. Received Tele-health monitoring
11276196|NCT02767011|BG001|Baseline|Control|Control Group (received standard of care)
11276197|NCT02767011|BG002|Baseline|Total|Total of all reporting groups
11276198|NCT02767011|FG000|Participant Flow|THEM|Intervention Group. Received Tele-health monitoring
11276199|NCT02767011|FG001|Participant Flow|Control|Control Group (received standard of care)
11276200|NCT02767011|OG000|Outcome|THEM|Intervention Group. Received Tele-health monitoring
11276201|NCT02767011|OG001|Outcome|Control|Control Group (received standard of care)
11276202|NCT02767011|EG000|Reported Event|THEM|Intervention Group. Received Tele-health monitoring
11276203|NCT02767011|EG001|Reported Event|Control|Control Group (received standard of care)
11276204|NCT02767128|BG000|Baseline|Safety Population|All 14 participants completed every arm of the study. Therefore, the baseline demographic characteristics of the Safety Population as a whole also reflect the characteristics of each arm of the study.
11276205|NCT02767128|FG000|Participant Flow|All Participants|This is a cross-over pharmacokinetic (PK) study where all participants underwent baseline blood sampling over 24 hours for PK purposes followed by five different oral treatments in a randomized sequence: Fer-In-Sol 3 mg Fe/kg, Shohl's solution 0.7 mL/kg followed 10 minutes later by Fer-In-Sol 3 mg Fe/kg, Triferic 3 mg Fe/kg, Shohl's solution 0.7 mL/kg followed 10 minutes later by Triferic 3 mg Fe/kg, and Shohl's solution 0.7 mL/kg followed immediately by Triferic 3 mg Fe/kg. 24 blood sampling for PK purposes took place at each randomized treatment visit. Once the randomized sequence was completed, all subjects were administered 6.6 mg Triferic intravenously at the last treatment visit, with blood sampling for PK purposes over 24 hours.
11276206|NCT02767128|OG000|Outcome|Treatment A|Patients will receive a single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
11276207|NCT02767128|OG001|Outcome|Treatment B|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.
11276208|NCT02767128|OG002|Outcome|Treatment C|Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.
11276209|NCT02767128|OG003|Outcome|Treatment D|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
11276210|NCT02767128|OG004|Outcome|Treatment E|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.
11276211|NCT02767128|OG005|Outcome|Treatment F|Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.
11276212|NCT02767128|EG000|Reported Event|Fer-In-Sol Orally|Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
11276213|NCT02767128|EG001|Reported Event|Shohl's Solution Followed by Fer-In-Sol Orally|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.
11276214|NCT02767128|EG002|Reported Event|Triferic Orally|Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.
11276215|NCT02767128|EG003|Reported Event|Shohl's Solution Followed by Triferic Orally|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
11276216|NCT02767128|EG004|Reported Event|Shohl's Solution Followed Immediately by Triferic|Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.
11276217|NCT02767128|EG005|Reported Event|Triferic Via IV|Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.
11276218|NCT02767271|BG000|Baseline|Tinea Pedis|Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276219|NCT02767271|BG001|Baseline|Tinea Cruris|Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276220|NCT02767271|BG002|Baseline|Total|Total of all reporting groups
11276221|NCT02767271|FG000|Participant Flow|Tinea Pedis|Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276222|NCT02767271|FG001|Participant Flow|Tinea Cruris|Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276223|NCT02767271|OG000|Outcome|Tinea Pedis|Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276224|NCT02767271|OG000|Outcome|Tinea Cruris|Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276225|NCT02767271|EG000|Reported Event|Tinea Pedis|Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276226|NCT02767271|EG001|Reported Event|Tinea Cruris|Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
11276227|NCT02767323|BG000|Baseline|Active or Sham rTMS Over the DLPFC (Aim1a)|"excitatory rTMS applied over the DLPFC (fMRI-guided)~rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design"
11276228|NCT02767323|BG001|Baseline|Active or Sham rTMS Over the Parietal Cortex (Aim1b)|"excitatory rTMS applied over the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design"
11276229|NCT02767323|BG002|Baseline|Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)|"excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design"
11276230|NCT02767323|BG003|Baseline|Active or Sham rTMS Over the DLPFC (Aim1a), Then Active or Sham rTMS Over the DLPFC (Aim1c)|"excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design"
11276231|NCT02767323|BG004|Baseline|Total|Total of all reporting groups
11276232|NCT02767323|FG000|Participant Flow|Active or Sham rTMS Over the DLPFC (Aim1a)|"excitatory rTMS applied over the DLPFC (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276233|NCT02767323|FG001|Participant Flow|Active or Sham rTMS Over the Parietal Cortex (Aim1b)|"excitatory rTMS applied over the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276234|NCT02767323|FG002|Participant Flow|Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)|"excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design"
11276235|NCT02767323|FG003|Participant Flow|Active/Sham rTMS Over DLPFC (Aim1a), Then Active/Sham rTMS Over DLPFC and Parietal Cortex (Aim1c)|"excitatory rTMS applied over the DLPFC (fMRI-guided) and the Parietal cortex~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276236|NCT02767323|OG000|Outcome|Active or Sham rTMS Over the DLPFC (Aim1a)|"excitatory rTMS applied over the DLPFC (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design"
11276237|NCT02767323|OG001|Outcome|Active or Sham rTMS Over the Parietal Cortex (Aim1b)|"excitatory rTMS applied over the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276238|NCT02767323|OG002|Outcome|Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)|"excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design"
11276239|NCT02767323|EG000|Reported Event|Active rTMS Over the DLPFC (Aim1a)|"excitatory rTMS applied over the DLPFC (fMRI-guided)~rTMS: excitatory 5Hz Active and Sham rTMS will be tested in a within subject design"
11276240|NCT02767323|EG001|Reported Event|Sham rTMS Over the DLPFC (Aim1a)|"excitatory rTMS applied over the DLPFC (fMRI-guided)~rTMS: excitatory 5Hz Active and Sham rTMS will be tested in a within subject design"
11276241|NCT02767323|EG002|Reported Event|Active rTMS Over the Parietal Cortex (Aim 1b)|"excitatory rTMS applied over the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276242|NCT02767323|EG003|Reported Event|Sham rTMS Over the Parietal Cortex (Aim 1b)|"excitatory rTMS applied over the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276243|NCT02767323|EG004|Reported Event|Active rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)|"excitatory rTMS applied over the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276244|NCT02767323|EG005|Reported Event|Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)|"excitatory rTMS applied over the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276245|NCT02767323|EG006|Reported Event|Active rTMS Over the DLPFC (Aim1a) Then Active rTMS Over the DLPFC and Parietal Cortex(Aim1c)|"excitatory rTMS applied over the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276246|NCT02767323|EG007|Reported Event|Sham rTMS Over the DLPFC (Aim1a) Then Sham rTMS Over the DLPFC and Parietal Cortex(Aim1c)|"excitatory rTMS applied over the DLPFC and the parietal cortex (fMRI-guided)~rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design"
11276247|NCT02767388|BG000|Baseline|HM - Chemotherapy|Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
11276248|NCT02767388|BG001|Baseline|HM - No Chemotherapy|Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
11276249|NCT02767388|BG002|Baseline|Healthy Controls|Study participants that are demographically matched to HM study patients and meet all inclusion criteria
11276250|NCT02767388|BG003|Baseline|Total|Total of all reporting groups
11276251|NCT02767388|FG000|Participant Flow|HM - Chemotherapy|Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
11276252|NCT02767388|FG001|Participant Flow|HM - No Chemotherapy|Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
11276253|NCT02767388|FG002|Participant Flow|Healthy Controls|Study participants that are demographically matched to HM study patients and meet all inclusion criteria
11276254|NCT02767388|OG000|Outcome|HM - Chemotherapy|Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
11276255|NCT02767388|OG001|Outcome|HM - No Chemotherapy|Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
11276256|NCT02767388|OG002|Outcome|Healthy Controls|Study participants that are demographically matched to HM study patients and meet all inclusion criteria
11276257|NCT02767388|EG000|Reported Event|HM - Chemotherapy|Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.
11276258|NCT02767388|EG001|Reported Event|HM - No Chemotherapy|Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.
11276259|NCT02767388|EG002|Reported Event|Healthy Controls|Study participants that are demographically matched to HM study patients and meet all inclusion criteria
11276260|NCT02767427|BG000|Baseline|At-Home Chlorhexidine|"Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate (CHG) wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.~Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site."
11276261|NCT02767427|BG001|Baseline|No At-Home Chlorhexidine|"Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.~No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure."
11276262|NCT02767427|BG002|Baseline|Total|Total of all reporting groups
11276263|NCT02767427|FG000|Participant Flow|At-Home Chlorhexidine|"Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.~Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site."
11092306|NCT01539083|FG001|Participant Flow|Thalidomide + Prednisolone (TP Consolidation)|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
11092307|NCT01539083|FG002|Participant Flow|Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
11276264|NCT02767427|FG001|Participant Flow|No At-Home Chlorhexidine|"Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.~No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure."
11276265|NCT02767427|OG000|Outcome|At-Home Chlorhexidine|"Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.~Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site."
11276266|NCT02767427|OG001|Outcome|No At-Home Chlorhexidine|"Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.~No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure."
10970418|NCT00910624|OG003|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
10970419|NCT00910624|OG000|Outcome|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
11276267|NCT02767427|EG000|Reported Event|At-Home Chlorhexidine|"Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.~Chlorhexidine Wipes: (Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site."
11276268|NCT02767427|EG001|Reported Event|No At-Home Chlorhexidine|"Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.~No intervention: Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure."
11276269|NCT02767492|BG000|Baseline|BioDRestore™|"BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.~BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee."
11276270|NCT02767492|BG001|Baseline|Corticosteroid|"Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.~Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee."
11276271|NCT02767492|BG002|Baseline|Total|Total of all reporting groups
11276272|NCT02767492|FG000|Participant Flow|BioDRestore™|"BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.~BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee."
11276273|NCT02767492|FG001|Participant Flow|Corticosteroid|"Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.~Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee."
11276274|NCT02767492|OG000|Outcome|BioDRestore™|"BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.~BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee."
11276275|NCT02767492|OG001|Outcome|Corticosteroid|"Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.~Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee."
11276276|NCT02767492|EG000|Reported Event|BioDRestore™|"BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.~BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee."
11276277|NCT02767492|EG001|Reported Event|Corticosteroid|"Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.~Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee."
11276278|NCT02767609|BG000|Baseline|Magentic Resonance Imaging|"Magnetic Resonance Imaging.~Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence."
11276279|NCT02767609|FG000|Participant Flow|Magentic Resonance Imaging|"Magnetic Resonance Imaging.~Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence."
11276280|NCT02767609|OG000|Outcome|Magentic Resonance Imaging|"Magnetic Resonance Imaging.~Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence."
11276281|NCT02767609|EG000|Reported Event|Magentic Resonance Imaging|"Magnetic Resonance Imaging.~Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence."
11276282|NCT02767765|BG000|Baseline|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
11276283|NCT02767765|FG000|Participant Flow|Recombinant Human Erythropoietin Beta (r-HuEPO)|Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
11276284|NCT02767765|OG000|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
11276285|NCT02767765|EG000|Reported Event|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
11276286|NCT02767843|BG000|Baseline|Treatment|"continuous negative external pressure (cNEP) at various negative pressures~continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced"
11092308|NCT01539083|OG000|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
11276287|NCT02767843|FG000|Participant Flow|Subjects|Only four subjects completed the study.
11276288|NCT02767843|OG000|Outcome|Subjects|Only four subjects were entered into the study. None had outcome measure (2) collected because of technical problems with data collection. Thus no interpretable data were collected.
11276289|NCT02767843|OG000|Outcome|Subjects|Only four subjects were entered into the study.
11276290|NCT02767843|OG000|Outcome|Subjects|Only four subjects were entered into the study. No efficacy data could be analyzed because of technical problems with the data collection equipment.
11276291|NCT02767843|EG000|Reported Event|All Subjects|Only four subjects completed the study.
11276292|NCT02767869|BG000|Baseline|Banaba|"Banaba capsules, 500mg, two times per day before meals during 90 days~Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day."
11276293|NCT02767869|BG001|Baseline|Placebo|"Calcined magnesia capsules, 500mg, two times per day before meals during 90 days~placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg"
11276294|NCT02767869|BG002|Baseline|Total|Total of all reporting groups
11276295|NCT02767869|FG000|Participant Flow|Banaba|"Banaba capsules, 500mg, two times per day before meals during 90 days~Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day."
11276296|NCT02767869|FG001|Participant Flow|Placebo|"Calcined magnesia capsules, 500mg, two times per day before meals during 90 days~placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg"
11276297|NCT02767869|OG000|Outcome|Banaba|"Banaba capsules, 500mg, two times per day before meals during 90 days~Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day."
11276298|NCT02767869|OG001|Outcome|Placebo|"Calcined magnesia capsules, 500mg, two times per day before meals during 90 days~placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg"
11276299|NCT02767869|EG000|Reported Event|Banaba|"Banaba capsules, 500mg, two times per day before meals during 90 days~Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day."
11276300|NCT02767869|EG001|Reported Event|Placebo|"Calcined magnesia capsules, 500mg, two times per day before meals during 90 days~placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg"
11276301|NCT02767934|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11276302|NCT02767934|FG000|Participant Flow|Pembrolizumab|Pembrolizumab for MRD in Adults with ALL
11276303|NCT02767934|OG000|Outcome|Pembrolizumab|"Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11276304|NCT02767934|OG000|Outcome|Pembrolizumab|Pembrolizumab for MRD in Adults with ALL
11276305|NCT02767934|EG000|Reported Event|Pembrolizumab|Pembrolizumab for MRD in Adults with ALL
11276306|NCT02767947|BG000|Baseline|Luliconazole Cream 1%|Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276307|NCT02767947|BG001|Baseline|Vehicle Cream|Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276308|NCT02767947|BG002|Baseline|Total|Total of all reporting groups
11276309|NCT02767947|FG000|Participant Flow|Luliconazole Cream 1%|Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276310|NCT02767947|FG001|Participant Flow|Vehicle Cream|Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276311|NCT02767947|OG000|Outcome|Luliconazole Cream 1%|Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276312|NCT02767947|OG001|Outcome|Vehicle Cream|Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276313|NCT02767947|EG000|Reported Event|Luliconazole Cream 1%|Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276314|NCT02767947|EG001|Reported Event|Vehicle Cream|Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
11276315|NCT02768103|BG000|Baseline|SCI Transfer + Training|Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
11276316|NCT02768103|FG000|Participant Flow|SCI Transfer + Training|"Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength)~task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space."
11276317|NCT02768103|OG000|Outcome|SCI Transfer + Training|Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength) task-based training: 10-week training program incorporates activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
11276318|NCT02768103|EG000|Reported Event|SCI Transfer + Training|Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer participate in 10 week home training program to improve surgical outcome (pinch strength). The 10-week training program includes activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback and knowledge of progress to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
11276319|NCT02768129|BG000|Baseline|Active tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~sham transcranial direct current stimulation: active : 2 mA, 20 mins"
11276320|NCT02768129|BG001|Baseline|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~sham transcranial direct current stimulation: sham"
11276321|NCT02768129|BG002|Baseline|Total|Total of all reporting groups
11276322|NCT02768129|FG000|Participant Flow|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~sham transcranial direct current stimulation: sham"
11276323|NCT02768129|FG001|Participant Flow|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins"
11276324|NCT02768129|OG000|Outcome|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~sham transcranial direct current stimulation: sham"
11276325|NCT02768129|OG001|Outcome|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins"
11276326|NCT02768129|EG000|Reported Event|Sham tDCS|"10 sessions sham transcranial direct current stimulation (tDCS)~sham transcranial direct current stimulation: sham"
11276327|NCT02768129|EG001|Reported Event|Active tDCS|"10 sessions active transcranial direct current stimulation (tDCS)~transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins"
11276328|NCT02768194|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
11286921|NCT02895360|OG002|Outcome|Phase 1 - 70 mg/m² Cohort|BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
11286922|NCT02895360|OG003|Outcome|Phase 1 - 90 mg/m² Cohort|BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
11276329|NCT02768194|FG000|Participant Flow|Test /Negative Control/Reference|Firstly, participants received dentifrice containing 0.454% stannous fluoride (test), secondly mineral water (negative control) and thirdly dentifrice containing 0.76% sodium monofluorophosphate (reference). Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 milliliters (mL) of mineral water for 5 seconds.
11276330|NCT02768194|FG001|Participant Flow|Test/Reference/Negative Control|Firstly, participants received test dentifrice, secondly reference dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276331|NCT02768194|FG002|Participant Flow|Negative Control/Test/Reference|Firstly, participants received negative control, secondly test dentifrice and thirdly reference dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276332|NCT02768194|FG003|Participant Flow|Negative Control/Reference/Test|Firstly, participants received negative control, secondly reference dentifrice and thirdly test dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276333|NCT02768194|FG004|Participant Flow|Reference/Test/Negative Control|Firstly, participants received reference dentifrice, secondly test dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276334|NCT02768194|FG005|Participant Flow|Reference/Negative Control/Test|Firstly, participants received reference dentifrice, secondly negative control and thirdly test dentrifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276335|NCT02768194|OG000|Outcome|Test Product|Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276336|NCT02768194|OG001|Outcome|Reference Product|Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276337|NCT02768194|OG002|Outcome|Negative Control|Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276338|NCT02768194|EG000|Reported Event|Test Product|Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276339|NCT02768194|EG001|Reported Event|Reference Product|Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11092309|NCT01539083|OG001|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
11276340|NCT02768194|EG002|Reported Event|Negative Control|Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
11276341|NCT02768298|BG000|Baseline|LCZ696|LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
11276342|NCT02768298|BG001|Baseline|Enalapril|"Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."
11276343|NCT02768298|BG002|Baseline|Total|Total of all reporting groups
11276344|NCT02768298|FG000|Participant Flow|LCZ696|LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
11276345|NCT02768298|FG001|Participant Flow|Enalapril|"Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."
11276346|NCT02768298|OG000|Outcome|LCZ696|LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
11276347|NCT02768298|OG001|Outcome|Enalapril|"Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."
11276348|NCT02768298|EG000|Reported Event|LCZ696|LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
11276349|NCT02768298|EG001|Reported Event|Enalapril|"Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."
10822102|NCT00074490|FG000|Participant Flow|Arm IVD Cohort 1 (Th2 DLI)|"Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).~Etoposide: Etoposide: 50 mg/m(2)/day continuous intravenous (CIV), days 1-4~Doxorubicin: Doxorubicin:10 mg/m(2)/day CIV, days 1-4~Vincristine: Vincristine:0.4 mg/m(2)/day CIV, days 1-4~Cyclophosphamide: Cyclophosphamide, 750 mg/m(2)/day IV, day 5~T cell donor lymphocyte infusion (DLI) with sirolimus generated donor TH-2 cells: The cell of the Th2 cells will attempt to be held constant for each study receipient (target dose 2.5 x 107 Th2/kg; minimum dose will be 1 x 107 Th2/kg)."
11276350|NCT02768558|BG000|Baseline|Nivolumab|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
11276351|NCT02768558|BG001|Baseline|Placebo|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
11276352|NCT02768558|BG002|Baseline|Total|Total of all reporting groups
11276353|NCT02768558|FG000|Participant Flow|Nivolumab|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
11276354|NCT02768558|FG001|Participant Flow|Placebo|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
11276355|NCT02768558|OG000|Outcome|Nivolumab|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
11276356|NCT02768558|OG001|Outcome|Placebo|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
11276357|NCT02768558|EG000|Reported Event|Nivolumab|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
11276358|NCT02768558|EG001|Reported Event|Placebo|60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
11276359|NCT02768753|BG000|Baseline|The Axillary Bilateral-breast Approach (ABBA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The Axillary Bilateral-breast Approach"
11276360|NCT02768753|BG001|Baseline|The Bilateral Axillo-breast Approach (BABA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The bilateral Axillo-breast Approach"
11276361|NCT02768753|BG002|Baseline|Total|Total of all reporting groups
11276362|NCT02768753|FG000|Participant Flow|The Axillary Bilateral-breast Approach (ABBA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The Axillary Bilateral-breast Approach"
11276363|NCT02768753|FG001|Participant Flow|The Bilateral Axillo-breast Approach (BABA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The bilateral Axillo-breast Approach"
11276364|NCT02768753|OG000|Outcome|The Axillary Bilateral-breast Approach (ABBA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The Axillary Bilateral-breast Approach"
11276365|NCT02768753|OG001|Outcome|The Bilateral Axillo-breast Approach (BABA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The bilateral Axillo-breast Approach"
11286923|NCT02895360|OG004|Outcome|Phase 2a - Ovarian Cancer Cohort|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11286924|NCT02895360|OG005|Outcome|Phase 2a - Recurrent Glioblastoma Cohort|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11276366|NCT02768753|EG000|Reported Event|The Axillary Bilateral-breast Approach (ABBA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The Axillary Bilateral-breast Approach"
11276367|NCT02768753|EG001|Reported Event|The Bilateral Axillo-breast Approach (BABA) Group|"All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.~The bilateral Axillo-breast Approach"
11276368|NCT02768792|BG000|Baseline|Single Arm Pembrolizumab|Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
11276369|NCT02768792|FG000|Participant Flow|Single Arm Pembrolizumab|Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
11276370|NCT02768792|OG000|Outcome|Single Arm Pembrolizumab|Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
11276371|NCT02768792|EG000|Reported Event|Single Arm Pembrolizumab|Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of High dose cytarabine (HiDAC) salvage induction chemotherapy. Subjects who have a response to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (beginning on day 1 of maintenance).Subjects who are ineligible for pembrolizumab administration by day 21 will be removed from the study.
11276372|NCT02769065|BG000|Baseline|SRD: Placebo Cohorts 1-6, 18 and 19|TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period.
11276373|NCT02769065|BG001|Baseline|SRD: Cohort 1: TAK-071 1 mg|TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.
11276374|NCT02769065|BG002|Baseline|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276375|NCT02769065|BG003|Baseline|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276376|NCT02769065|BG004|Baseline|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276377|NCT02769065|BG005|Baseline|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
10822103|NCT00074490|FG001|Participant Flow|Arm IVD Cohort 3 (Multiple Th2 DLI)|Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
11276378|NCT02769065|BG006|Baseline|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276379|NCT02769065|BG007|Baseline|MRD: Placebo Cohorts 7-9|TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period.
11276380|NCT02769065|BG008|Baseline|MRD: Cohort 7: TAK-071 3 mg|TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.
11276381|NCT02769065|BG009|Baseline|MRD: Cohort 8: TAK-071 9 mg|TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276382|NCT02769065|BG010|Baseline|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276383|NCT02769065|BG011|Baseline|MRD: TAK-071 Placebo Cohorts 10-12+Donepezil|TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071.
11276384|NCT02769065|BG012|Baseline|MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg|TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276385|NCT02769065|BG013|Baseline|MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg|TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276386|NCT02769065|BG014|Baseline|MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg|TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276387|NCT02769065|BG015|Baseline|MRD: Placebo Cohorts 13-15|TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants.
11276388|NCT02769065|BG016|Baseline|MRD: Cohort 13: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276389|NCT02769065|BG017|Baseline|MRD: Cohort 14: TAK-071 9 mg|TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276390|NCT02769065|BG018|Baseline|MRD: Cohort 15: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276391|NCT02769065|BG019|Baseline|Cohort 16|TAK-071 capsule, orally, once on Day 1 for 21 days, followed by a washout period of 21 days, or placebo matching tablets, orally, once on Day 1 for 21 days. Donepezil was delivered as 5 mg tablet, orally, once followed by 10 mg tablet, orally, once in run-in period.
11276392|NCT02769065|BG020|Baseline|Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC|A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1, followed by B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 2, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276393|NCT02769065|BG021|Baseline|BA/Food Effect: Cohort 17 Sequence BCA|B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the Fed state in Period 2, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276394|NCT02769065|BG022|Baseline|BA/Food Effect: Cohort 17 Sequence CAB|C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 2, followed by B: TAK-20 10 mg tablet, orally, once on Day 1 in the fasted state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276395|NCT02769065|BG023|Baseline|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276396|NCT02769065|BG024|Baseline|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276397|NCT02769065|BG025|Baseline|SRD: TAK-071 Placebo+Donepezil Placebo|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants.
11276398|NCT02769065|BG026|Baseline|SRD: TAK-071 Placebo+Donepezil|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants.
11276399|NCT02769065|BG027|Baseline|SRD: Cohort 20: TAK-071 40 mg+Donepezil|TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.
11276400|NCT02769065|BG028|Baseline|SRD: Cohort 21: TAK-071 60 mg+Donepezil|TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.
11276401|NCT02769065|BG029|Baseline|SRD: Cohort 22: TAK-071 80 mg+Donepezil|TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.
11276402|NCT02769065|BG030|Baseline|Total|Total of all reporting groups
11276403|NCT02769065|FG000|Participant Flow|SRD: Placebo Cohorts 1-6, 18 and 19|TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period.
11276404|NCT02769065|FG001|Participant Flow|SRD: Cohort 1: TAK-071 1 mg|TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.
11276405|NCT02769065|FG002|Participant Flow|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276406|NCT02769065|FG003|Participant Flow|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276407|NCT02769065|FG004|Participant Flow|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276408|NCT02769065|FG005|Participant Flow|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
11276409|NCT02769065|FG006|Participant Flow|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276410|NCT02769065|FG007|Participant Flow|MRD: Placebo Cohorts 7-9|TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period.
11276411|NCT02769065|FG008|Participant Flow|MRD: Cohort 7: TAK-071 3 mg|TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.
11276412|NCT02769065|FG009|Participant Flow|MRD: Cohort 8: TAK-071 9 mg|TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276413|NCT02769065|FG010|Participant Flow|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276414|NCT02769065|FG011|Participant Flow|MRD: TAK-071 Placebo Cohorts 10-12+Donepezil|TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071.
11276415|NCT02769065|FG012|Participant Flow|MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg|TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276416|NCT02769065|FG013|Participant Flow|MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg|TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276417|NCT02769065|FG014|Participant Flow|MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg|TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276418|NCT02769065|FG015|Participant Flow|MRD: Placebo Cohorts 13-15|TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants.
11276419|NCT02769065|FG016|Participant Flow|MRD: Cohort 13: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276420|NCT02769065|FG017|Participant Flow|MRD: Cohort 14: TAK-071 9 mg|TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276421|NCT02769065|FG018|Participant Flow|MRD: Cohort 15: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276422|NCT02769065|FG019|Participant Flow|Cohort 16|TAK-071 capsule, orally, once on Day 1 for 21 days, followed by a washout period of 21 days, or placebo matching tablets, orally, once on Day 1 for 21 days. Donepezil was delivered as 5 mg tablet, orally, once followed by 10 mg tablet, orally, once in run-in period.
11276423|NCT02769065|FG020|Participant Flow|Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC|A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1, followed by B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 2, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276424|NCT02769065|FG021|Participant Flow|BA/Food Effect: Cohort 17 Sequence BCA|B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the Fed state in Period 2, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276425|NCT02769065|FG022|Participant Flow|BA/Food Effect: Cohort 17 Sequence CAB|C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 2, followed by B: TAK-20 10 mg tablet, orally, once on Day 1 in the fasted state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.
11276426|NCT02769065|FG023|Participant Flow|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276427|NCT02769065|FG024|Participant Flow|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276428|NCT02769065|FG025|Participant Flow|SRD: TAK-071 Placebo+Donepezil Placebo|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants.
11276429|NCT02769065|FG026|Participant Flow|SRD: TAK-071 Placebo+Donepezil|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants.
11276430|NCT02769065|FG027|Participant Flow|SRD: Cohort 20: TAK-071 40 mg+Donepezil|TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.
11276431|NCT02769065|FG028|Participant Flow|SRD: Cohort 21: TAK-071 60 mg+Donepezil|TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.
11276432|NCT02769065|FG029|Participant Flow|SRD: Cohort 22: TAK-071 80 mg+Donepezil|TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.
11276433|NCT02769065|OG000|Outcome|SRD: Placebo Cohorts 1-6, 18 and 19|TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period.
11276434|NCT02769065|OG001|Outcome|SRD: Cohort 1: TAK-071 1 mg|TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.
11276435|NCT02769065|OG002|Outcome|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276436|NCT02769065|OG003|Outcome|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276437|NCT02769065|OG004|Outcome|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276438|NCT02769065|OG005|Outcome|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
11276439|NCT02769065|OG006|Outcome|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276440|NCT02769065|OG007|Outcome|MRD: Placebo Cohorts 7-9|TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period.
11276441|NCT02769065|OG008|Outcome|MRD: Cohort 7: TAK-071 3 mg|TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.
11276442|NCT02769065|OG009|Outcome|MRD: Cohort 8: TAK-071 9 mg|TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276443|NCT02769065|OG010|Outcome|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276444|NCT02769065|OG011|Outcome|MRD: TAK-071 Placebo Cohorts 10-12+Donepezil|TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071.
11276445|NCT02769065|OG012|Outcome|MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg|TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276446|NCT02769065|OG013|Outcome|MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg|TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276447|NCT02769065|OG014|Outcome|MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg|TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276448|NCT02769065|OG015|Outcome|MRD: Placebo Cohorts 13-15|TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants.
11276449|NCT02769065|OG016|Outcome|MRD: Cohort 13: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276450|NCT02769065|OG017|Outcome|MRD: Cohort 14: TAK-071 9 mg|TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11092310|NCT01539083|EG000|Reported Event|Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
11276451|NCT02769065|OG018|Outcome|MRD: Cohort 15: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276452|NCT02769065|OG019|Outcome|Bioavailability (BA)/Food Effect: Cohort 17 Regimen A|TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11276453|NCT02769065|OG020|Outcome|BA/Food Effect: Cohort 17 Regimen B|TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11092311|NCT01539083|EG001|Reported Event|Thalidomide + Prednisolone (TP Consolidation)|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
11286925|NCT02895360|OG000|Outcome|30 mg/m² Cycle 1 Day 1|BAL101553 30 mg/m² Cohort Cycle 1 Day 1
11276454|NCT02769065|OG021|Outcome|BA/Food Effect: Cohort 17 Regimen C|TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3
11276455|NCT02769065|OG022|Outcome|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276456|NCT02769065|OG023|Outcome|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276457|NCT02769065|OG024|Outcome|SRD: TAK-071 Placebo+Donepezil Placebo|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants.
11276458|NCT02769065|OG025|Outcome|SRD: TAK-071 Placebo+Donepezil|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants.
11276459|NCT02769065|OG026|Outcome|SRD: Cohort 20: TAK-071 40 mg+Donepezil|TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.
11276460|NCT02769065|OG027|Outcome|SRD: Cohort 21: TAK-071 60 mg+Donepezil|TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.
11276461|NCT02769065|OG028|Outcome|SRD: Cohort 22: TAK-071 80 mg+Donepezil|TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.
11276462|NCT02769065|OG000|Outcome|SRD: Cohort 1: TAK-071 1 mg|TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.
11276463|NCT02769065|OG001|Outcome|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276464|NCT02769065|OG002|Outcome|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276465|NCT02769065|OG003|Outcome|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276466|NCT02769065|OG004|Outcome|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
11276467|NCT02769065|OG005|Outcome|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276468|NCT02769065|OG006|Outcome|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276469|NCT02769065|OG007|Outcome|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276470|NCT02769065|OG000|Outcome|MRD: Cohort 7: TAK-071 3 mg|TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.
11276471|NCT02769065|OG001|Outcome|MRD: Cohort 8: TAK-071 9 mg|TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276472|NCT02769065|OG000|Outcome|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276473|NCT02769065|OG000|Outcome|MRD: Cohort 13: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276474|NCT02769065|OG001|Outcome|MRD: Cohort 14: TAK-071 9 mg|TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276475|NCT02769065|OG002|Outcome|MRD: Cohort 15: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276476|NCT02769065|OG000|Outcome|MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg|TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276477|NCT02769065|OG001|Outcome|MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg|TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276478|NCT02769065|OG002|Outcome|MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg|TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276479|NCT02769065|OG000|Outcome|Bioavailability (BA)/Food Effect: Cohort 17 Regimen A|TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11276480|NCT02769065|OG001|Outcome|BA/Food Effect: Cohort 17 Regimen B|TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11276481|NCT02769065|OG002|Outcome|BA/Food Effect: Cohort 17 Regimen C|TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3
11276482|NCT02769065|OG000|Outcome|SRD: Cohort 20: TAK-071 40 mg+Donepezil|TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.
11276483|NCT02769065|OG001|Outcome|SRD: Cohort 21: TAK-071 60 mg+Donepezil|TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.
11276484|NCT02769065|OG002|Outcome|SRD: Cohort 22: TAK-071 80 mg+Donepezil|TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.
11276485|NCT02769065|OG002|Outcome|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276486|NCT02769065|OG000|Outcome|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276487|NCT02769065|OG001|Outcome|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276488|NCT02769065|OG002|Outcome|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276489|NCT02769065|OG003|Outcome|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
11276490|NCT02769065|OG004|Outcome|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276491|NCT02769065|OG005|Outcome|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276492|NCT02769065|OG006|Outcome|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276493|NCT02769065|OG000|Outcome|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276494|NCT02769065|EG000|Reported Event|SRD: Placebo Cohorts 1-6, 18 and 19|TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period.
11276495|NCT02769065|EG001|Reported Event|SRD: Cohort 1: TAK-071 1 mg|TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.
11276496|NCT02769065|EG002|Reported Event|SRD: Cohort 2: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.
11276497|NCT02769065|EG003|Reported Event|SRD: Cohort 3: TAK-071 9 mg|TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.
11276498|NCT02769065|EG004|Reported Event|SRD: Cohort 4: TAK-071 20 mg|TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.
11276499|NCT02769065|EG005|Reported Event|SRD: Cohort 5: TAK-071 40 mg|TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.
11276500|NCT02769065|EG006|Reported Event|SRD: Cohort 6: TAK-071 80 mg|TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5
11276501|NCT02769065|EG007|Reported Event|MRD: Placebo Cohorts 7-9|TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period.
11276502|NCT02769065|EG008|Reported Event|MRD: Cohort 7: TAK-071 3 mg|TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.
11276503|NCT02769065|EG009|Reported Event|MRD: Cohort 8: TAK-071 9 mg|TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276504|NCT02769065|EG010|Reported Event|MRD: Cohort 9: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.
11276505|NCT02769065|EG011|Reported Event|MRD: TAK-071 Placebo Cohorts 10-12+Donepezil|TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071.
11286926|NCT02895360|OG001|Outcome|30 mg/m² Cycle 2 Day 1|BAL101553 30 mg/m² Cohort Cycle 2 Day 1
11286927|NCT02895360|OG002|Outcome|45 mg/m² Cycle 1 Day 1|BAL101553 45 mg/m² Cohort Cycle 1 Day 1
11286928|NCT02895360|OG003|Outcome|45 mg/m² Cycle 2 Day 1|BAL101553 45 mg/m² Cohort Cycle 2 Day 1
11276506|NCT02769065|EG012|Reported Event|MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg|TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276507|NCT02769065|EG013|Reported Event|MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg|TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276508|NCT02769065|EG014|Reported Event|MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg|TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276509|NCT02769065|EG015|Reported Event|MRD: Placebo Cohorts 13-15|TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants.
11276510|NCT02769065|EG016|Reported Event|MRD: Cohort 13: TAK-071 3 mg|TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.
11276511|NCT02769065|EG017|Reported Event|MRD: Cohort 14: TAK-071 9 mg|TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.
11276512|NCT02769065|EG018|Reported Event|MRD: Cohort 15: TAK-071 15 mg|TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.
11276513|NCT02769065|EG019|Reported Event|Cohort 16|TAK-071 capsule, orally, once on Day 1 for 21 days, followed by a washout period of 21 days, or placebo matching tablets, orally, once on Day 1 for 21 days. Donepezil was delivered as 5 mg tablet, orally, once followed by 10 mg tablet, orally, once in run-in period.
11276514|NCT02769065|EG020|Reported Event|Bioavailability (BA)/Food Effect: Cohort 17 Regimen A|TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11276515|NCT02769065|EG021|Reported Event|BA/Food Effect: Cohort 17 Regimen B|TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3
11276516|NCT02769065|EG022|Reported Event|BA/Food Effect: Cohort 17 Regimen C|TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3
11276517|NCT02769065|EG023|Reported Event|SRD: Cohort 18: TAK-071 120 mg|TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.
11276518|NCT02769065|EG024|Reported Event|SRD: Cohort 19: TAK-071 160 mg|TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.
11276519|NCT02769065|EG025|Reported Event|SRD: TAK-071 Placebo+Donepezil Placebo|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants.
11276520|NCT02769065|EG026|Reported Event|SRD: TAK-071 Placebo+Donepezil|TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants.
11276521|NCT02769065|EG027|Reported Event|SRD: Cohort 20: TAK-071 40 mg+Donepezil|TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.
10970420|NCT00910624|EG000|Reported Event|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
10970421|NCT00910663|BG000|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
10970422|NCT00910663|BG001|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
10970423|NCT00910663|BG002|Baseline|Total|Total of all reporting groups
10970424|NCT00910663|FG000|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
10970425|NCT00910663|FG001|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
10970426|NCT00910663|OG000|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
10970427|NCT00910663|OG001|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
11276522|NCT02769065|EG028|Reported Event|SRD: Cohort 21: TAK-071 60 mg+Donepezil|TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.
11276523|NCT02769065|EG029|Reported Event|SRD: Cohort 22: TAK-071 80 mg+Donepezil|TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.
11276524|NCT02769247|BG000|Baseline|Placebo|"Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion~placebo: either normal saline or empty oral capsule"
11276525|NCT02769247|BG001|Baseline|Naproxen/Normal Saline|"Patient will receive naproxen and intrauterine normal saline prior to IUD insertion~Naproxen: Oral naproxen vs placebo~placebo: either normal saline or empty oral capsule"
11276526|NCT02769247|BG002|Baseline|Placebo Oral Medication/Lidocaine|"Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion~Lidocaine: Intrauterine lidocaine vs normal saline~placebo: either normal saline or empty oral capsule"
11276527|NCT02769247|BG003|Baseline|Naproxen/Lidocaine|"Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion~Naproxen: Oral naproxen vs placebo~Lidocaine: Intrauterine lidocaine vs normal saline"
11276528|NCT02769247|BG004|Baseline|Total|Total of all reporting groups
11276529|NCT02769247|FG000|Participant Flow|Placebo|"Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion~placebo: either normal saline or empty oral capsule"
11276530|NCT02769247|FG001|Participant Flow|Naproxen/Normal Saline|"Patient will receive naproxen and intrauterine normal saline prior to IUD insertion~Naproxen: Oral naproxen vs placebo~placebo: either normal saline or empty oral capsule"
11276531|NCT02769247|FG002|Participant Flow|Placebo Oral Medication/Lidocaine|"Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion~Lidocaine: Intrauterine lidocaine vs normal saline~placebo: either normal saline or empty oral capsule"
11276532|NCT02769247|FG003|Participant Flow|Naproxen/Lidocaine|"Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion~Naproxen: Oral naproxen vs placebo~Lidocaine: Intrauterine lidocaine vs normal saline"
11276533|NCT02769247|OG000|Outcome|Placebo|"Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion~placebo: either normal saline or empty oral capsule"
11276534|NCT02769247|OG001|Outcome|Naproxen/Normal Saline|"Patient will receive naproxen and intrauterine normal saline prior to IUD insertion~Naproxen: Oral naproxen vs placebo~placebo: either normal saline or empty oral capsule"
11276535|NCT02769247|OG002|Outcome|Placebo Oral Medication/Lidocaine|"Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion~Lidocaine: Intrauterine lidocaine vs normal saline~placebo: either normal saline or empty oral capsule"
11276536|NCT02769247|OG003|Outcome|Naproxen/Lidocaine|"Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion~Naproxen: Oral naproxen vs placebo~Lidocaine: Intrauterine lidocaine vs normal saline"
10847441|NCT00283283|OG001|Outcome|Age 18 - 49, Half Dose|"0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
11276537|NCT02769247|OG000|Outcome|Mirena|All treatment arms that received this type IUD
11276538|NCT02769247|OG001|Outcome|Paragard IUD|All treatment arms
11276539|NCT02769247|OG000|Outcome|Mirena Medication Use|All treatment arms receiving mirena IUD
11276540|NCT02769247|OG001|Outcome|Paragard|All treatment arms receiving paragard IUD
11276541|NCT02769247|EG000|Reported Event|Placebo|"Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion~placebo: either normal saline or empty oral capsule"
11276542|NCT02769247|EG001|Reported Event|Naproxen/Normal Saline|"Patient will receive naproxen and intrauterine normal saline prior to IUD insertion~Naproxen: Oral naproxen vs placebo~placebo: either normal saline or empty oral capsule"
11276543|NCT02769247|EG002|Reported Event|Placebo Oral Medication/Lidocaine|"Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion~Lidocaine: Intrauterine lidocaine vs normal saline~placebo: either normal saline or empty oral capsule"
11276544|NCT02769247|EG003|Reported Event|Naproxen/Lidocaine|"Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion~Naproxen: Oral naproxen vs placebo~Lidocaine: Intrauterine lidocaine vs normal saline"
11276545|NCT02769312|BG000|Baseline|Sham Stimulation|Participants allocated to receive sham TBS during the double-blind period
10847442|NCT00283283|OG000|Outcome|Age 50 - 64, Full Dose|"0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
10847443|NCT00283283|OG001|Outcome|Age 50 - 64, Half Dose|"0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
10847444|NCT00283283|OG000|Outcome|Mild|Mild AE
10847445|NCT00283283|OG001|Outcome|Moderate|Moderate AE
10847446|NCT00283283|OG002|Outcome|Severe, Able to Work|Severe but able to work
10847447|NCT00283283|OG003|Outcome|Severe, Lost Productivity|Severe and lost productivity
10847448|NCT00283283|OG004|Outcome|No Events|No adverse events recorded
10847449|NCT00283283|OG000|Outcome|Aged 18-49 y (n=558)|Race/Ethnicity stratified by age 18-49
10847450|NCT00283283|OG001|Outcome|Aged 50-64 y (n=556)|Race/Ethnicity stratified by age 50-64
10847451|NCT00283283|EG000|Reported Event|Full Dose|"0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
10847452|NCT00283283|EG001|Reported Event|Half Dose|"0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain~Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"
11276546|NCT02769312|BG001|Baseline|Active Stimulation|Participants allocated to receive active TBS during the double-blind period.
11276547|NCT02769312|BG002|Baseline|Total|Total of all reporting groups
11276548|NCT02769312|FG000|Participant Flow|Sham Stimulation|Participants allocated to receive sham TBS during the double-blind period
11276549|NCT02769312|FG001|Participant Flow|Active Stimulation|Participants allocated to receive active TBS during the double-blind period.
11276550|NCT02769312|OG000|Outcome|Sham Stimulation|Participants allocated to receive sham TBS during the double-blind period
11276551|NCT02769312|OG001|Outcome|Active Stimulation|Participants allocated to receive active TBS during the double-blind period.
11276552|NCT02769312|EG000|Reported Event|Pre-Allocation|Participants consented at formal in-person eligibility determination.
11276553|NCT02769312|EG001|Reported Event|Sham Stimulation|Participants allocated to receive sham TBS during the double-blind period
11276554|NCT02769312|EG002|Reported Event|Active Stimulation|Participants allocated to receive active TBS during the double-blind period.
11276555|NCT02769351|BG000|Baseline|Periph. Minimal Invasive Ultrafiltration|"Patients with volume overload receiving ultrafiltration~periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle"
11276556|NCT02769351|FG000|Participant Flow|Periph. Minimal Invasive Ultrafiltration|"Patients with volume overload receiving ultrafiltration~periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle"
11276557|NCT02769351|OG000|Outcome|Periph. Minimal Invasive Ultrafiltration|"Patients with volume overload receiving ultrafiltration~periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle"
11276558|NCT02769351|OG000|Outcome|Periph. Minimal Invasive Ultrafiltration|Patients with volume overload receiving ultrafiltration
11276559|NCT02769351|EG000|Reported Event|Periph. Minimal Invasive Ultrafiltration|"Patients with volume overload receiving ultrafiltration~periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle"
11276560|NCT02769442|BG000|Baseline|Terumo SurFlash Plus Catheter|Patients randomized to the Terumo catheter
11276561|NCT02769442|BG001|Baseline|BD Insyte Autoguard Catheter|Patients randomized to the BD catheter
11276562|NCT02769442|BG002|Baseline|Total|Total of all reporting groups
11276563|NCT02769442|FG000|Participant Flow|Terumo SurFlash Plus Catheter|Patients randomized to the Terumo catheter
11276564|NCT02769442|FG001|Participant Flow|Becton Dickinson (BD) Insyte Autoguard Catheter|Patients randomized to the Becton Dickinson (BD) catheter
11276565|NCT02769442|OG000|Outcome|Terumo SurFlash Plus Catheter|Patients randomized to the Terumo catheter
11276566|NCT02769442|OG001|Outcome|BD Insyte Autoguard Catheter|Patients randomized to the BD catheter
11276567|NCT02769442|EG000|Reported Event|Terumo SurFlash Plus Catheter|Patients randomized to the Terumo catheter
11276568|NCT02769442|EG001|Reported Event|BD Insyte Autoguard Catheter|Patients randomized to the BD catheter
11276569|NCT02769481|BG000|Baseline|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride for the duration of the study.~Bexagliflozin tablets: 20 mg~Glimepiride capsules: Placebo, inactive capsule to match the active comparator"
11276570|NCT02769481|BG001|Baseline|Glimepiride|"Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Bexagliflozin: Placebo, inactive tablet to match the active comparator~Glimepiride capsules: 2, 4 or 6 mg"
11276571|NCT02769481|BG002|Baseline|Total|Total of all reporting groups
11276572|NCT02769481|FG000|Participant Flow|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride for the duration of the study.~Bexagliflozin tablets: 20 mg~Glimepiride capsules: Placebo, inactive capsule to match the active comparator"
11276573|NCT02769481|FG001|Participant Flow|Glimepiride|"Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Bexagliflozin: Placebo, inactive tablet to match the active comparator~Glimepiride capsules: 2, 4 or 6 mg"
11276574|NCT02769481|OG000|Outcome|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride for the duration of the study.~Bexagliflozin tablets: 20 mg~Glimepiride capsules: Placebo, inactive capsule to match the active comparator"
11276575|NCT02769481|OG001|Outcome|Glimepiride|"Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Bexagliflozin: Placebo, inactive tablet to match the active comparator~Glimepiride capsules: 2, 4 or 6 mg"
11276576|NCT02769481|EG000|Reported Event|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride for the duration of the study.~Bexagliflozin tablets: 20 mg~Glimepiride capsules: Placebo, inactive capsule to match the active comparator"
11276577|NCT02769481|EG001|Reported Event|Glimepiride|"Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Bexagliflozin: Placebo, inactive tablet to match the active comparator~Glimepiride capsules: 2, 4 or 6 mg"
11286929|NCT02895360|OG004|Outcome|70 mg/m² Cycle 1 Day 1|BAL101553 70 mg/m² Cohort Cycle 1 Day 1
11286930|NCT02895360|OG005|Outcome|70 mg/m² Cycle 2 Day 1|BAL101553 70 mg/m² Cohort Cycle 2 Day 1
11286931|NCT02895360|OG006|Outcome|90 mg/m² Cycle 1 Day 1|BAL101553 90 mg/m² Cohort Cycle 1 Day 1
11286932|NCT02895360|OG007|Outcome|90 mg/m² Cycle 2 Day 1|BAL101553 90 mg/m² Cohort Cycle 2 Day 1
11276578|NCT02769624|BG000|Baseline|Treprostinil Crossover With Placebo|"Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.~If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.~If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276579|NCT02769624|FG000|Participant Flow|Treprostinil, Then Placebo|"A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.~Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.~A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.~Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276580|NCT02769624|FG001|Participant Flow|Placebo, Then Treprostinil|"A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.~Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.~A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.~Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276581|NCT02769624|OG000|Outcome|Treprostinil|"A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.~Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276582|NCT02769624|OG001|Outcome|Placebo|"A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.~Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276583|NCT02769624|EG000|Reported Event|Treprostinil|"Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.~If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.~If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276584|NCT02769624|EG001|Reported Event|Placebo|"Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.~If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.~If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing."
11276585|NCT02769702|BG000|Baseline|Acthar 80 IU|Acthar 80 IU SC twice week
11276586|NCT02769702|FG000|Participant Flow|Acthar 80 IU|Acthar 80 IU SC twice week
11276587|NCT02769702|OG000|Outcome|Acthar 80 IU|Acthar 80 IU SC twice week
11276588|NCT02769702|EG000|Reported Event|Acthar 80 IU|Acthar 80 IU SC twice week
11276589|NCT02769858|BG000|Baseline|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
11276590|NCT02769858|FG000|Participant Flow|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
11276591|NCT02769858|OG000|Outcome|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
11276592|NCT02769858|EG000|Reported Event|Light Therapy|"Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.~Light therapy: Light therapy glasses"
11276593|NCT02770014|BG000|Baseline|Participants With Plasma Genotyping|Participants who enrolled to the study and had plasma genotyping
11276594|NCT02770014|FG000|Participant Flow|Participants With Plasma Genotyping|Participants who enrolled to the study and had plasma genotyping
11276595|NCT02770014|OG000|Outcome|EGFR Exon 19 Positive Treatment With Erlotinib|Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
11276596|NCT02770014|OG000|Outcome|Participants With Plasma Genotyping|Participants who enrolled to the study and had plasma genotyping
11276597|NCT02770014|EG000|Reported Event|EGFR Exon 19 Positive Treatment With Erlotinib|Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
11276598|NCT02770170|BG000|Baseline|120 mg BI 655064|Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276599|NCT02770170|BG001|Baseline|180 mg BI 655064|Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276600|NCT02770170|BG002|Baseline|240 mg BI 655064|Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
11276601|NCT02770170|BG003|Baseline|Placebo|Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
11276602|NCT02770170|BG004|Baseline|Total|Total of all reporting groups
11276603|NCT02770170|FG000|Participant Flow|120 mg BI 655064|Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276604|NCT02770170|FG001|Participant Flow|180 mg BI 655064|Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276605|NCT02770170|FG002|Participant Flow|240 mg BI 655064|Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
11092312|NCT01539083|EG002|Reported Event|Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
11276606|NCT02770170|FG003|Participant Flow|Placebo|Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
11276607|NCT02770170|OG000|Outcome|120 mg BI 655064|Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276608|NCT02770170|OG001|Outcome|180 mg BI 655064|Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276609|NCT02770170|OG002|Outcome|240 mg BI 655064|Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
11276610|NCT02770170|OG003|Outcome|Placebo|Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
11276611|NCT02770170|EG000|Reported Event|120 mg BI 655064|Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276612|NCT02770170|EG001|Reported Event|180 mg BI 655064|Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
11276613|NCT02770170|EG002|Reported Event|240 mg BI 655064|Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
11276614|NCT02770170|EG003|Reported Event|Placebo|Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
11276615|NCT02770248|BG000|Baseline|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276616|NCT02770248|BG001|Baseline|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276617|NCT02770248|BG002|Baseline|Total|Total of all reporting groups
11276618|NCT02770248|FG000|Participant Flow|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276619|NCT02770248|FG001|Participant Flow|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276620|NCT02770248|OG000|Outcome|SIMBRINZA|Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276621|NCT02770248|OG001|Outcome|Vehicle|Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
11276622|NCT02770248|EG000|Reported Event|SIMBRINZA|All subjects exposed to SIMBRINZA
11276623|NCT02770248|EG001|Reported Event|Vehicle|All subjects exposed to Vehicle
11276624|NCT02770287|BG000|Baseline|Venus Freeze Diamond Polar|"Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment.~Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study."
10970428|NCT00910663|EG000|Reported Event|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
10970429|NCT00910663|EG001|Reported Event|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
10970430|NCT00910689|BG000|Baseline|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
10970431|NCT00910689|BG001|Baseline|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
10970432|NCT00910689|BG002|Baseline|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
10970433|NCT00910689|BG003|Baseline|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
10970434|NCT00910689|BG004|Baseline|Total|Total of all reporting groups
11286933|NCT02895360|OG000|Outcome|30 mg/m²|Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
11286934|NCT02895360|OG001|Outcome|45 mg/m²|Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
10970435|NCT00910689|FG000|Participant Flow|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
10970436|NCT00910689|FG001|Participant Flow|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
10970437|NCT00910689|FG002|Participant Flow|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
10970438|NCT00910689|FG003|Participant Flow|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
10970439|NCT00910689|OG000|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
10970440|NCT00910689|OG001|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
10970441|NCT00910689|OG002|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
10970442|NCT00910689|OG003|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
10970443|NCT00910689|EG000|Reported Event|OAT + Placebo (PL) at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
10970444|NCT00910689|EG001|Reported Event|OAT + Beta-Blocker at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
10970445|NCT00910689|EG002|Reported Event|OAT + BMM + PL at Month 5|"Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5)."
10970446|NCT00910689|EG003|Reported Event|OAT + BMM + Beta-Blocker at Month 5|"Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5)."
10970447|NCT00910715|BG000|Baseline|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
10970448|NCT00910715|BG001|Baseline|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
10970449|NCT00910715|BG002|Baseline|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
10970450|NCT00910715|BG003|Baseline|Total|Total of all reporting groups
10970451|NCT00910715|FG000|Participant Flow|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
10970452|NCT00910715|FG001|Participant Flow|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
10970453|NCT00910715|FG002|Participant Flow|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
10970454|NCT00910715|OG000|Outcome|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
10970455|NCT00910715|OG001|Outcome|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
10970456|NCT00910715|OG002|Outcome|Controls|subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
10970457|NCT00910715|OG000|Outcome|EM Patients|EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
10970458|NCT00910715|OG001|Outcome|Controls|control subjects without a history of Lyme borreliosis
10970459|NCT00910715|EG000|Reported Event|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
10970460|NCT00910715|EG001|Reported Event|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
10970461|NCT00910715|EG002|Reported Event|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
10970462|NCT00910728|BG000|Baseline|2.5 mg QD|AZD1480 may be administered orally in capsules
10970463|NCT00910728|BG001|Baseline|5.0 mg QD|AZD1480 may be administered orally in capsules
10970464|NCT00910728|BG002|Baseline|10 mg QD|AZD1480 may be administered orally in capsules
10970465|NCT00910728|BG003|Baseline|70 mg QD|AZD1480 may be administered orally in capsules
10970466|NCT00910728|BG004|Baseline|15 mg BID|AZD1480 may be administered orally in capsules
10970467|NCT00910728|BG005|Baseline|30 mg QD|AZD1480 may be administered orally in capsules
10970468|NCT00910728|BG006|Baseline|50 mg QD|AZD1480 may be administered orally in capsules
10970469|NCT00910728|BG007|Baseline|10 mg BID|AZD1480 may be administered orally in capsules
10970470|NCT00910728|BG008|Baseline|20 mg QD|AZD1480 may be administered orally in capsules
11276625|NCT02770287|FG000|Participant Flow|Treatment Group|"Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment.~Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study."
11276626|NCT02770287|OG000|Outcome|Venus Freeze Diamond Polar|"Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment.~Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study."
11276627|NCT02770287|OG000|Outcome|VAS - Labia Treatment|Subjects recorded their assessment of pain on the 10cm Visual Analogue Scale (VAS) after each treatment.
11276628|NCT02770287|OG000|Outcome|VAS - Mons Pubis Treatment|Subjects re
11276629|NCT02770287|OG000|Outcome|Vaginal pH|The vaginal pH was obtained from all subjects at each visit.
11276630|NCT02770287|EG000|Reported Event|Venus Freeze Diamond Polar|"Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment.~Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study."
11276631|NCT02770365|BG000|Baseline|Test Product|"estradiol cream~estrace cream (Perrigo)"
11276632|NCT02770365|BG001|Baseline|Reference Product|"estradiol cream~estrace cream (Reference)"
11276633|NCT02770365|BG002|Baseline|Placebo Product|"Placebo cream~Placebo cream"
10970471|NCT00910728|BG009|Baseline|Total|Total of all reporting groups
10970472|NCT00910728|FG000|Participant Flow|2.5 mg QD|AZD1480 may be administered orally in capsules
10970473|NCT00910728|FG001|Participant Flow|5.0 mg QD|AZD1480 may be administered orally in capsules
10970474|NCT00910728|FG002|Participant Flow|10 mg QD|AZD1480 may be administered orally in capsules
10970475|NCT00910728|FG003|Participant Flow|30 mg QD|AZD1480 may be administered orally in capsules
10970476|NCT00910728|FG004|Participant Flow|50 mg QD|AZD1480 may be administered orally in capsules
10970477|NCT00910728|FG005|Participant Flow|70 mg QD|AZD1480 may be administered orally in capsules
10970478|NCT00910728|FG006|Participant Flow|10 mg BID|AZD1480 may be administered orally in capsules
10970479|NCT00910728|FG007|Participant Flow|15 mg BID|AZD1480 may be administered orally in capsules
10970480|NCT00910728|FG008|Participant Flow|20 mg QD|AZD1480 may be administered orally in capsules
10970481|NCT00910728|OG000|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
10970482|NCT00910728|OG001|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
10970483|NCT00910728|OG002|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
10970484|NCT00910728|OG003|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
10970485|NCT00910728|OG004|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
10970486|NCT00910728|OG005|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
10970487|NCT00910728|OG006|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
10970488|NCT00910728|OG007|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
10970489|NCT00910728|OG008|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
10970490|NCT00910728|EG000|Reported Event|2.5 mg QD|AZD1480 may be administered orally in capsules
10970491|NCT00910728|EG001|Reported Event|5.0 mg QD|AZD1480 may be administered orally in capsules
10970492|NCT00910728|EG002|Reported Event|10 mg QD|AZD1480 may be administered orally in capsules
10970493|NCT00910728|EG003|Reported Event|70 mg QD|AZD1480 may be administered orally in capsules
10970494|NCT00910728|EG004|Reported Event|15 mg BID|AZD1480 may be administered orally in capsules
10970495|NCT00910728|EG005|Reported Event|20 mg QD|AZD1480 may be administered orally in capsules
10970496|NCT00910728|EG006|Reported Event|30 mg QD|AZD1480 may be administered orally in capsules
10970497|NCT00910728|EG007|Reported Event|50 mg QD|AZD1480 may be administered orally in capsules
10970498|NCT00910728|EG008|Reported Event|10 mg BID|AZD1480 may be administered orally in capsules
11214860|NCT02294773|BG001|Baseline|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214861|NCT02294773|BG002|Baseline|Total|Total of all reporting groups
11214862|NCT02294773|FG000|Participant Flow|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214863|NCT02294773|FG001|Participant Flow|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214864|NCT02294773|OG000|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214865|NCT02294773|OG001|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214866|NCT02294773|EG000|Reported Event|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214867|NCT02294773|EG001|Reported Event|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
11214868|NCT02294786|BG000|Baseline|Octreotide Treatment|Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
11214869|NCT02294786|BG001|Baseline|No Octreotide Treatment|Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
11214870|NCT02294786|BG002|Baseline|Total|Total of all reporting groups
11214871|NCT02294786|FG000|Participant Flow|Octreotide Treatment|Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
11214872|NCT02294786|FG001|Participant Flow|No Octreotide Treatment|Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
11214873|NCT02294786|OG000|Outcome|Octreotide Treatment|Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
11214874|NCT02294786|OG001|Outcome|No Octreotide Treatment|Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
11214875|NCT02294786|EG000|Reported Event|Octreotide Treatment|Octreotide+Lap+Cap
11214876|NCT02294786|EG001|Reported Event|No Octreotide Treatment|Lap+Cap
11276634|NCT02770365|BG003|Baseline|Total|Total of all reporting groups
11276635|NCT02770365|FG000|Participant Flow|Test Product|"estradiol cream~estrace cream (Perrigo)"
10847453|NCT00283296|BG000|Baseline|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
11214877|NCT02294786|EG002|Reported Event|All Patients|All Patients
11214878|NCT02295020|BG000|Baseline|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
11214879|NCT02295020|BG001|Baseline|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
11214880|NCT02295020|BG002|Baseline|Total|Total of all reporting groups
11214881|NCT02295020|FG000|Participant Flow|Standard Treatment Only.|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
11214882|NCT02295020|FG001|Participant Flow|Standard Treatment Plus Bioskin Ten-7.|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
11214883|NCT02295020|OG000|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
11214884|NCT02295020|OG001|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
11214885|NCT02295020|OG000|Outcome|Standard Treatment Only.|Standard treatment only such as NSAIDs and injections.
11214886|NCT02295020|OG000|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
11214887|NCT02295020|OG001|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
11214888|NCT02295020|OG001|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace
11214889|NCT02295020|OG000|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
11214890|NCT02295020|OG001|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
11214891|NCT02295020|EG000|Reported Event|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
11214892|NCT02295020|EG001|Reported Event|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
11214893|NCT02295280|BG000|Baseline|Metoclopramide IV & Diphenhydramine IV|Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.
11214894|NCT02295280|BG001|Baseline|Codeine|Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.
11214895|NCT02295280|BG002|Baseline|Total|Total of all reporting groups
11214896|NCT02295280|FG000|Participant Flow|Metoclopramide IV & Diphenhydramine IV|"Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A~Metoclopramide: IV~Diphenhydramine: iv"
11214897|NCT02295280|FG001|Participant Flow|Codeine|"Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.~Codeine: PO"
11214898|NCT02295280|OG000|Outcome|Metoclopramide IV & Diphenhydramine IV|Number of patients who received Metoclopramide & diphenhydramine IV
11214899|NCT02295280|OG001|Outcome|Codeine|Number of patients who received codeine
11214900|NCT02295280|EG000|Reported Event|Metoclopramide & Diphenhydramine|Participants received intravenous metoclopramine (10 mg) and diphenhydramine (25 mg), up to two doses of each medication.
11214901|NCT02295280|EG001|Reported Event|Codeine|Participants received oral 30 mg of oral codeine (up to two doses).
11214902|NCT02295553|BG000|Baseline|Ketamine 0 mg/kg|"Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.~Propofol"
11214903|NCT02295553|BG001|Baseline|Ketamine 0.25 mg/kg|"Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214904|NCT02295553|BG002|Baseline|Ketamine 0.5 mg/kg|"Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214905|NCT02295553|BG003|Baseline|Ketamine 1.0 mg/kg|"Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214906|NCT02295553|BG004|Baseline|Total|Total of all reporting groups
11214907|NCT02295553|FG000|Participant Flow|Ketamine 0 mg/kg|"Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.~Propofol"
11214908|NCT02295553|FG001|Participant Flow|Ketamine 0.25 mg/kg|"Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214909|NCT02295553|FG002|Participant Flow|Ketamine 0.5 mg/kg|"Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214910|NCT02295553|FG003|Participant Flow|Ketamine 1.0 mg/kg|"Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11276636|NCT02770365|FG001|Participant Flow|Reference Product|"estradiol cream~estrace cream (Reference)"
11276637|NCT02770365|FG002|Participant Flow|Placebo Product|"Placebo cream~Placebo cream"
11276638|NCT02770365|OG000|Outcome|Test Product|"estradiol cream~estrace cream (Perrigo)"
11276639|NCT02770365|OG001|Outcome|Reference Product|"estradiol cream~estrace cream (Reference)"
11276640|NCT02770365|OG002|Outcome|Placebo Product|"Placebo cream~Placebo cream"
11276641|NCT02770365|EG000|Reported Event|Test Product|"estradiol cream~estrace cream (Perrigo)"
11276642|NCT02770365|EG001|Reported Event|Reference Product|"estradiol cream~estrace cream (Reference)"
11276643|NCT02770365|EG002|Reported Event|Placebo Product|"Placebo cream~Placebo cream"
11276644|NCT02770521|BG000|Baseline|Treprostinil or Placebo (Part A)|Participants received either 1000 ng of treprostinil or matching placebo as a SC injection once in each of two study periods.
11276645|NCT02770521|BG001|Baseline|LY900014 or Insulin Lispro (Part B)|Participants received each of three doses of LY900014 (7.5 U, 15 U, 30 U) or 15 U of insulin lispro as a SC injection once in each of three study periods.
11276646|NCT02770521|BG002|Baseline|Total|Total of all reporting groups
11276647|NCT02770521|FG000|Participant Flow|Placebo/Treprostinil (Part A)|Placebo given subcutaneously (SC) once in first study period. 1,000 nanograms (ng) of treprostinil given SC once in second study period. There was a minimum three day washout between doses.
11276648|NCT02770521|FG001|Participant Flow|Treprostinil/Placebo (Part A)|1,000 ng of treprostinil given SC once in first study period. Matching placebo given SC once in second study period. There was a minimum three day washout between doses.
11276649|NCT02770521|FG002|Participant Flow|15 U Insulin Lispro/15 U LY900014/30 U LY900014 (Part B)|15 units (U) insulin lispro given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
11276650|NCT02770521|FG003|Participant Flow|7.5 U LY900014/15 U Insulin Lispro/30 U LY900014 (Part B)|7.5 U LY900014 given SC once in first study period. 15 U insulin lispro given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
11276651|NCT02770521|FG004|Participant Flow|7.5 U LY900014/15 U LY900014/15 U Insulin Lispro (Part B)|7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 15 U insulin lispro given SC once in third study period. There was a minimum three day washout between doses.
11276652|NCT02770521|FG005|Participant Flow|7.5 U LY900014/15 U LY900014/30 U LY900014 (Part B)|7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
11276653|NCT02770521|OG000|Outcome|Placebo (Part A)|Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
11276654|NCT02770521|OG001|Outcome|Treprostinil (Part A)|1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
11276655|NCT02770521|OG002|Outcome|15 U Insulin Lispro (Part B)|15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276656|NCT02770521|OG003|Outcome|7.5 U LY900014 (Part B)|7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276657|NCT02770521|OG004|Outcome|15 U LY900014 (Part B)|15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276658|NCT02770521|OG005|Outcome|30 U LY900014 (Part B)|30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276659|NCT02770521|OG000|Outcome|7.5 U LY900014 (Part B)|7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276660|NCT02770521|OG001|Outcome|15 U LY900014 (Part B)|15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276661|NCT02770521|OG002|Outcome|30 U LY900014 (Part B)|30 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276662|NCT02770521|OG000|Outcome|Treprostinil (Part A)|1,000 ng treprostinil administered as a single subcutaneous (SC) injection in one of two study periods.
11276663|NCT02770521|EG000|Reported Event|Placebo (Part A)|Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
11276664|NCT02770521|EG001|Reported Event|Treprostinil (Part A)|1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
11276665|NCT02770521|EG002|Reported Event|15 U Insulin Lispro (Part B)|15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276666|NCT02770521|EG003|Reported Event|7.5 U LY900014 (Part B)|7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276667|NCT02770521|EG004|Reported Event|15 U LY900014 (Part B)|15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276668|NCT02770521|EG005|Reported Event|30 U LY900014 (Part B)|30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
11276669|NCT02770547|BG000|Baseline|Low Heat Thermotherapy|"Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.~Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg."
11276670|NCT02770547|BG001|Baseline|High Heat Thermotherapy|"High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.~High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg."
11276671|NCT02770547|BG002|Baseline|Total|Total of all reporting groups
11276672|NCT02770547|FG000|Participant Flow|Low Heat Thermotherapy|"Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.~Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg."
11276673|NCT02770547|FG001|Participant Flow|High Heat Thermotherapy|"High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.~High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg."
11276674|NCT02770547|OG000|Outcome|Low Heat Thermotherapy|"Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.~Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg."
11276675|NCT02770547|OG001|Outcome|High Heat Thermotherapy|"High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.~High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg."
11276676|NCT02770547|EG000|Reported Event|Low Heat Thermotherapy|"Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.~Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg."
11276677|NCT02770547|EG001|Reported Event|High Heat Thermotherapy|"High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.~High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg."
11276678|NCT02770612|BG000|Baseline|Massachusetts General Hospital|"Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria~English speaking~using oral oxycodone~age >=18~post-operative length of stay less than 8 days~no history of chronic pain or chronic opioid use~lack of contraindications to tylenol/NSAIDs"
11276679|NCT02770612|FG000|Participant Flow|Post-cesarean Delivery Mothers|Intervention: 10-minute shared decision making session via tablet
11276680|NCT02770612|OG000|Outcome|Massachusetts General Hospital|"Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria~English speaking~using oral oxycodone~age >=18~post-operative length of stay less than 8 days~no history of chronic pain or chronic opioid use~lack of contraindications to tylenol/NSAIDs"
11276681|NCT02770612|EG000|Reported Event|Post-cesarean Delivery Mothers|"Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria~English speaking~using oral oxycodone~age >=18~post-operative length of stay less than 8 days~no history of chronic pain or chronic opioid use~lack of contraindications to tylenol/NSAIDs"
11276682|NCT02770625|BG000|Baseline|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
11276683|NCT02770625|FG000|Participant Flow|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
11276684|NCT02770625|OG000|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
11276685|NCT02770625|EG000|Reported Event|ISU302|"60 U/kg (once every 2 weeks for 6 months)~ISU302: 60 U/kg given intravenously"
11276686|NCT02770820|BG000|Baseline|Treatment (Autologous CD8 T Cells)|"Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11276687|NCT02770820|FG000|Participant Flow|Treatment (Autologous CD8 T Cells)|"Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11276688|NCT02770820|OG000|Outcome|Treatment (Autologous CD8 T Cells)|"Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11286935|NCT02895360|OG002|Outcome|70 mg/m²|Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
11286936|NCT02895360|OG003|Outcome|90 mg/m²|Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
11286937|NCT02895360|OG000|Outcome|Phase 1- in the FAP|"All dose cohorts (30 mg/m², 45 mg/m², 70 mg/m² and 90 mg/m²) of BAL101553 in patients with advanced solid tumors~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2"
11276689|NCT02770820|EG000|Reported Event|Treatment (Autologous CD8 T Cells)|"Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician.~Aldesleukin: Given SC~Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV~Laboratory Biomarker Analysis: Correlative studies"
11276690|NCT02770846|BG000|Baseline|Immediate Loading|Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.
11276691|NCT02770846|BG001|Baseline|Delayed Loading|Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
11276692|NCT02770846|BG002|Baseline|Total|Total of all reporting groups
11276693|NCT02770846|FG000|Participant Flow|Immediate Loading|"Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion~Immediate loading"
11276694|NCT02770846|FG001|Participant Flow|Delayed Loading|"Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.~Delayed loading"
11276695|NCT02770846|OG000|Outcome|Immediate Loading|Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.
11276696|NCT02770846|OG001|Outcome|Delayed Loading|Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
11276697|NCT02770846|OG000|Outcome|Immediate Loading|"Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion~Immediate loading"
11276698|NCT02770846|OG001|Outcome|Delayed Loading|"Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.~Delayed loading"
11276699|NCT02770846|EG000|Reported Event|Immediate Loading|Immediate loading with a screw-retained temporary crown and replacement with a permanent crown.
11276700|NCT02770846|EG001|Reported Event|Delayed Loading|Delayed loading with a temporary crown to optimize the emergence profile and replacement with a permanent crown.
11276701|NCT02771093|BG000|Baseline|Trelagliptin 100 mg|Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
11276702|NCT02771093|BG001|Baseline|Alogliptin 25 mg|Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
11276703|NCT02771093|BG002|Baseline|Total|Total of all reporting groups
11276704|NCT02771093|FG000|Participant Flow|Trelagliptin 100 mg|Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
11276705|NCT02771093|FG001|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
11276706|NCT02771093|OG000|Outcome|Trelagliptin 100 mg|Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
11276707|NCT02771093|OG001|Outcome|Alogliptin 25 mg|Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
11276708|NCT02771093|EG000|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
11276709|NCT02771093|EG001|Reported Event|Trelagliptin 100 mg|Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
11276710|NCT02771145|BG000|Baseline|FID 120947A|FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
11276711|NCT02771145|FG000|Participant Flow|FID 120947A|FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
11276712|NCT02771145|OG000|Outcome|FID 120947A|FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
11276713|NCT02771145|OG000|Outcome|Type II|Films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification
11276714|NCT02771145|OG001|Outcome|Type III|Films or deposits readily visible on a dry lens under room lighting, with unaided eye
11276715|NCT02771145|OG002|Outcome|Type IV|Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
11276716|NCT02771145|OG000|Outcome|≥3 Line Increase|
11276717|NCT02771145|OG001|Outcome|2 Line Increase|
11276718|NCT02771145|OG002|Outcome|1 Line Increase|
11276719|NCT02771145|OG003|Outcome|No Change|
11276720|NCT02771145|OG004|Outcome|1 Line Decrease|
11276721|NCT02771145|OG005|Outcome|2 Line Decrease|
11276722|NCT02771145|OG006|Outcome|≥3 Line Decrease|
11276723|NCT02771145|OG000|Outcome|Strongly Agree|
11276724|NCT02771145|OG001|Outcome|Agree|
11276725|NCT02771145|OG002|Outcome|Undecided|
11276726|NCT02771145|OG003|Outcome|Disagree|
11276727|NCT02771145|OG004|Outcome|Strongly Disagree|
11276728|NCT02771145|EG000|Reported Event|FID 120977A - Subject Based Adverse Events|All subjects treated with FID 120947A contact lens disinfecting solution
11276729|NCT02771145|EG001|Reported Event|FID 120977A - Ocular Adverse Events|All eyes treated with FID 120947A contact lens disinfecting solution
11276730|NCT02771210|BG000|Baseline|Secukinumab|Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276731|NCT02771210|BG001|Baseline|Placebo|Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276732|NCT02771210|BG002|Baseline|Total|Total of all reporting groups
11286938|NCT02895360|OG001|Outcome|Phase 2a - Patients With Ovarian Cancer in the FAP|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11276733|NCT02771210|FG000|Participant Flow|Secukinumab|Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276734|NCT02771210|FG001|Participant Flow|Placebo|Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276735|NCT02771210|OG000|Outcome|Secukinumab|Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276736|NCT02771210|OG001|Outcome|Placebo|Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276737|NCT02771210|EG000|Reported Event|Secukinumab|Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276738|NCT02771210|EG001|Reported Event|Placebo-Secukinumab|Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
11276739|NCT02771340|BG000|Baseline|ICON-1 0.3 mg Singe Dose|"Patients will receive a single intravitreal dose of ICON-1 0.3 mg~ICON-1: Intravitreal injection of ICON-1"
11276740|NCT02771340|BG001|Baseline|ICON-1 0.3 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276741|NCT02771340|BG002|Baseline|ICON-1 0.6 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276742|NCT02771340|BG003|Baseline|Total|Total of all reporting groups
11276743|NCT02771340|FG000|Participant Flow|ICON-1 0.3 mg Singe Dose|"Patients will receive a single intravitreal dose of ICON-1 0.3 mg~ICON-1: Intravitreal injection of ICON-1"
11276744|NCT02771340|FG001|Participant Flow|ICON-1 0.3 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276745|NCT02771340|FG002|Participant Flow|ICON-1 0.6 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276746|NCT02771340|OG000|Outcome|ICON-1 0.3 mg Singe Dose|"Patients will receive a single intravitreal dose of ICON-1 0.3 mg~ICON-1: Intravitreal injection of ICON-1"
11276747|NCT02771340|OG001|Outcome|ICON-1 0.3 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276748|NCT02771340|OG002|Outcome|ICON-1 0.6 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276749|NCT02771340|EG000|Reported Event|ICON-1 0.3 mg Singe Dose|"Patients will receive a single intravitreal dose of ICON-1 0.3 mg~ICON-1: Intravitreal injection of ICON-1"
11276750|NCT02771340|EG001|Reported Event|ICON-1 0.3 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276751|NCT02771340|EG002|Reported Event|ICON-1 0.6 mg Repeat Dosing|"Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart~ICON-1: Intravitreal injection of ICON-1"
11276752|NCT02771366|BG000|Baseline|Fermented Papaya Preparation First Arm|"Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276753|NCT02771366|BG001|Baseline|Granulated Sugar First Arm|"Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276754|NCT02771366|BG002|Baseline|Total|Total of all reporting groups
11276755|NCT02771366|FG000|Participant Flow|Fermented Papaya Preparation Arm|"Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276756|NCT02771366|FG001|Participant Flow|Granulated Sugar Arm|"Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276757|NCT02771366|OG000|Outcome|Fermented Papaya Preparation Arm|"Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276758|NCT02771366|OG001|Outcome|Granulated Sugar Arm|"Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276759|NCT02771366|EG000|Reported Event|Fermented Papaya Preparation Arm|"Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276760|NCT02771366|EG001|Reported Event|Granulated Sugar Arm|"Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken.~Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.~Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22.~Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22."
11276761|NCT02771366|EG002|Reported Event|Washout Period|This is the 6 week period between the FPP and Placebo arms.
11276762|NCT02771522|BG000|Baseline|Active Post-othodontic Lesions|"Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, each active tooth was again be imaged at 2, 4, 8 and 12 weeks. In order to improve study recruitment, a Protocol Amendment was approved to reduce the overall number of visits to 2, 4 and 8 weeks, however there is data available form all time points.~The images of the teeth are taken immediately before and after application of a small amount of solution. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11276763|NCT02771522|FG000|Participant Flow|Active Post-othodontic Lesions|"Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, active teeth were again imaged at 2, 4, 8 and 12 weeks.~Black & white and luminescent images of the teeth were taken. The images of each tooth were overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11276764|NCT02771522|OG000|Outcome|Active Post-othodontic Lesions|Imaging with the Calcivis System - Percentage teeth with luminescence over time
11276765|NCT02771522|OG000|Outcome|Post-orthodontic Lesions|Imaging with the Calcivis System - Percentage teeth with luminescence over time, per Investigator
11276766|NCT02771522|OG000|Outcome|Active Post-othodontic Lesions|Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & white and luminescent images of the teeth were taken. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
11276767|NCT02771522|OG000|Outcome|Post-orthodontic Lesions|Imaging with the Calcivis System -Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & White and luminescent images were taken. he images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
11276768|NCT02771522|OG000|Outcome|Post-orthodontic Lesions|Imaging with the Calcivis System -Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & White and luminescent images were taken. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
11276769|NCT02771522|OG000|Outcome|Active Post-othodontic Lesions|"Imaging with the Calcivis System -~User Questionnaires comprised four questions and users were asked to tick the most appropriate response on a three-point scale"
11276770|NCT02771522|EG000|Reported Event|Active Post-othodontic Lesions|Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. The images of the teeth are taken immediately before and after application of a small amount of disclosing solution. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
11276771|NCT02771574|BG000|Baseline|Part A: Lyo Avexitide 0.05 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276772|NCT02771574|BG001|Baseline|Part A: Lyo Avexitide 0.15 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276773|NCT02771574|BG002|Baseline|Part A: Lyo Avexitide 0.35 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276774|NCT02771574|BG003|Baseline|Part A: Lyo Avexitide 0.46 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276775|NCT02771574|BG004|Baseline|Part B: Liq Avexitide 0.38 mg/kg|Liq avexitide administered sc twice daily for 3 days
11276776|NCT02771574|BG005|Baseline|Total|Total of all reporting groups
11276777|NCT02771574|FG000|Participant Flow|Part A: Lyo Avexitide 0.5 mg/kg|Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc) twice daily for 3 days
11276778|NCT02771574|FG001|Participant Flow|Part A: Lyo Avexitide 0.15 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276779|NCT02771574|FG002|Participant Flow|Part A: Lyo Avexitide 0.35 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276780|NCT02771574|FG003|Participant Flow|Part A: Lyo Avexitide 0.46 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276781|NCT02771574|FG004|Participant Flow|Part B: Liq Avexitide 0.38 (±0.03) mg/kg|Liquid avexitide (Liq avexitide) administered sc twice daily for 3 days
11276782|NCT02771574|OG000|Outcome|Part A: Lyo Avexitide 0.5 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276783|NCT02771574|OG001|Outcome|Part A: Lyo Avexitide 0.15 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276784|NCT02771574|OG002|Outcome|Part A: Lyo Avexitide 0.35 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276785|NCT02771574|OG003|Outcome|Part A: Lyo Avexitide 0.46 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276786|NCT02771574|OG004|Outcome|Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups|"Lyo avexitide administered sc twice daily for 3 days~This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups."
11276787|NCT02771574|OG005|Outcome|Part B: Liq Avexitide 0.38 (±0.03) mg/kg|Liq avexitide administered sc twice daily for 3 days
11276788|NCT02771574|OG000|Outcome|Part A: Lyo Avexitide 0.05 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276789|NCT02771574|OG004|Outcome|Part B: Liq Avexitide 0.38 (±0.03) mg/kg|Liq avexitide administered sc twice daily for 3 days
11276790|NCT02771574|EG000|Reported Event|Part A: Lyo Avexitide 0.05 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276791|NCT02771574|EG001|Reported Event|Part A: Lyo Avexitide 0.15 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276792|NCT02771574|EG002|Reported Event|Part A: Lyo Avexitide 0.35 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276793|NCT02771574|EG003|Reported Event|Part A: Lyo Avexitide 0.46 mg/kg|Lyo avexitide administered sc twice daily for 3 days
11276794|NCT02771574|EG004|Reported Event|Part B: Liq Avexitide 0.38 (±0.03) mg/kg|Liq avexitide administered sc twice daily for 3 days
11276795|NCT02772302|BG000|Baseline|mindBEAGLE (Inpatient Participants)|"Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface~mindBEAGLE EEG-based brain-computer interface"
11276796|NCT02772302|BG001|Baseline|mindBEAGLE (Healthy Controls)|Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface tested in healthy controls to provide baseline validation of the technology.
11276797|NCT02772302|BG002|Baseline|Total|Total of all reporting groups
11276798|NCT02772302|FG000|Participant Flow|mindBEAGLE|"Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface~mindBEAGLE EEG-based brain-computer interface"
11276799|NCT02772302|FG001|Participant Flow|Healthy Controls|healthy subjects with no history of neurological disease
11276800|NCT02772302|OG000|Outcome|mindBEAGLE|"Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface~mindBEAGLE EEG-based brain-computer interface"
11276801|NCT02772302|OG001|Outcome|Healthy Control Subjects|Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface
11276802|NCT02772302|EG000|Reported Event|mindBEAGLE|"Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface~mindBEAGLE EEG-based brain-computer interface"
11276803|NCT02772302|EG001|Reported Event|Healthy Controls|healthy subjects with no history of neurological disease
11276804|NCT02772432|BG000|Baseline|3RP Treatment|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~Relaxation Response Resiliency Training for Parents of SPLD"
11276805|NCT02772432|BG001|Baseline|Waitlist Control|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.~Relaxation Response Resiliency Training for Parents of SPLD"
11276806|NCT02772432|BG002|Baseline|Total|Total of all reporting groups
11276807|NCT02772432|FG000|Participant Flow|3RP Treatment|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~Relaxation Response Resiliency Training for Parents of SPLD"
11276808|NCT02772432|FG001|Participant Flow|Waitlist Control|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.~Relaxation Response Resiliency Training for Parents of SPLD"
11276809|NCT02772432|OG000|Outcome|3RP Treatment|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~Relaxation Response Resiliency Training for Parents of SPLD"
11276810|NCT02772432|OG001|Outcome|Waitlist Control|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.~Relaxation Response Resiliency Training for Parents of SPLD"
11276811|NCT02772432|EG000|Reported Event|3RP Treatment|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.~Relaxation Response Resiliency Training for Parents of SPLD"
11276812|NCT02772432|EG001|Reported Event|Waitlist Control|"An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.~Relaxation Response Resiliency Training for Parents of SPLD"
11276813|NCT02772666|BG000|Baseline|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
11276814|NCT02772666|FG000|Participant Flow|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
11276815|NCT02772666|OG000|Outcome|O-Glass|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
11276816|NCT02772666|OG001|Outcome|Swinging Flashlight Test|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
11276817|NCT02772666|EG000|Reported Event|All Study Participants|This diagnostic intervention is just an inspection and taking picture of the eye.
11276818|NCT02772757|BG000|Baseline|Standard of Care Group|"Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach~standard hearing aid fitting: standard hearing aid, face-to-face fitting"
11276819|NCT02772757|BG001|Baseline|Average RECD Group|"This group will have their hearing aid fitting via the coupler using average RECD values during the fitting~coupler-based fitting: coupler-based fitting using average RECDs"
11276820|NCT02772757|BG002|Baseline|Measured RECD Group|"This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting~coupler-based fitting: coupler-based fitting using measured RECDs"
11276821|NCT02772757|BG003|Baseline|Total|Total of all reporting groups
11276822|NCT02772757|FG000|Participant Flow|Standard of Care Group|"Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach~standard hearing aid fitting: standard hearing aid, face-to-face fitting"
11276823|NCT02772757|FG001|Participant Flow|Average RECD Group|"This group will have their hearing aid fitting via the coupler using average RECD values during the fitting~coupler-based fitting: coupler-based fitting using average RECDs"
11276824|NCT02772757|FG002|Participant Flow|Measured RECD Group|"This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting~coupler-based fitting: coupler-based fitting using measured RECDs"
11276825|NCT02772757|OG000|Outcome|Standard of Care Group|"Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach~standard hearing aid fitting: standard hearing aid, face-to-face fitting"
11276826|NCT02772757|OG001|Outcome|Average RECD Group|"This group will have their hearing aid fitting via the coupler using average RECD values during the fitting~coupler-based fitting: coupler-based fitting using average RECDs"
11276827|NCT02772757|OG002|Outcome|Measured RECD Group|"This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting~coupler-based fitting: coupler-based fitting using measured RECDs"
11276828|NCT02772757|OG000|Outcome|Standard of Care Group|This group received the standard of care fitting with in site real ear verification
11276829|NCT02772757|EG000|Reported Event|Standard of Care Group|"Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach~standard hearing aid fitting: standard hearing aid, face-to-face fitting"
11276830|NCT02772757|EG001|Reported Event|Average RECD Group|"This group will have their hearing aid fitting via the coupler using average RECD values during the fitting~coupler-based fitting: coupler-based fitting using average RECDs"
11276831|NCT02772757|EG002|Reported Event|Measured RECD Group|"This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting~coupler-based fitting: coupler-based fitting using measured RECDs"
11276832|NCT02772783|BG000|Baseline|All Study Participants|"In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage:~High GI meal covered with IV insulin to to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.~1-week wash-out~Low GI meal covered with IV insulin to achieve euglycemia (comparison condition B); 1 day.~1-week wash-out~High GI meal with IV insulin matching the low GI meal, resulting in hyperglycemia (experimental condition A); 1 day.~The order of experimental conditions A and B was randomized.~High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.~Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration.~Because all participants completed all interventions, results are presented in aggregate for the entire study group."
11286939|NCT02895360|OG002|Outcome|Phase 2a - Patients With Ovarian Cancer in the EEP|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11286940|NCT02895360|OG003|Outcome|Phase 2a - Patients With Recurrent Glioblastoma in the FAP|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11286941|NCT02895360|OG004|Outcome|Phase 2a - Patients With Recurrent Glioblastoma in the EEP|"BAL101553 at 70 mg/m² (MTD)~BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle"
11214911|NCT02295553|OG000|Outcome|Ketamine 0 mg/kg|"Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.~Propofol"
11214912|NCT02295553|OG001|Outcome|Ketamine 0.25 mg/kg|"Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214913|NCT02295553|OG002|Outcome|Ketamine 0.5 mg/kg|"Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214914|NCT02295553|OG003|Outcome|Ketamine 1.0 mg/kg|"Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214915|NCT02295553|EG000|Reported Event|Ketamine 0 mg/kg|"Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.~Propofol"
11214916|NCT02295553|EG001|Reported Event|Ketamine 0.25 mg/kg|"Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214917|NCT02295553|EG002|Reported Event|Ketamine 0.5 mg/kg|"Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214918|NCT02295553|EG003|Reported Event|Ketamine 1.0 mg/kg|"Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.~Ketamine~Propofol"
11214919|NCT02295644|BG000|Baseline|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214920|NCT02295644|BG001|Baseline|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214921|NCT02295644|BG002|Baseline|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214922|NCT02295644|BG003|Baseline|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214923|NCT02295644|BG004|Baseline|Total|Total of all reporting groups
11214924|NCT02295644|FG000|Participant Flow|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214925|NCT02295644|FG001|Participant Flow|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214926|NCT02295644|FG002|Participant Flow|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214927|NCT02295644|FG003|Participant Flow|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214928|NCT02295644|OG000|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214929|NCT02295644|OG001|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214930|NCT02295644|OG002|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214931|NCT02295644|OG003|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214932|NCT02295644|EG000|Reported Event|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214933|NCT02295644|EG001|Reported Event|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214934|NCT02295644|EG002|Reported Event|C(0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214935|NCT02295644|EG003|Reported Event|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
11214936|NCT02295735|BG000|Baseline|Intervention Group|For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.
11214937|NCT02295735|BG001|Baseline|Control Group|Standard pressure ulcer prevention according to hospital standard
11214938|NCT02295735|BG002|Baseline|Total|Total of all reporting groups
11214939|NCT02295735|FG000|Participant Flow|Intervention Group|For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.
11214940|NCT02295735|FG001|Participant Flow|Control Group|Standard pressure ulcer prevention according to hospital standard
11214941|NCT02295735|OG000|Outcome|Intervention Group|For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.
11214942|NCT02295735|OG001|Outcome|Control Group|Standard pressure ulcer prevention according to hospital standard
11214943|NCT02295735|EG000|Reported Event|Intervention Group|For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.
11214944|NCT02295735|EG001|Reported Event|Control Group|Standard pressure ulcer prevention according to hospital standard
11214945|NCT02295774|BG000|Baseline|MB MMX 200mg|"Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy.~Subjects were counted as part of an analysis group once they had received the IMP. The discontinued subjects in this study we discontinued before received the IMP."
11214946|NCT02295774|FG000|Participant Flow|MB MMX 200mg|"Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take 200mg Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
11214947|NCT02295774|OG000|Outcome|MB MMX 200mg|"Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
11214948|NCT02295774|OG000|Outcome|MB MMX 200mg|"Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take 200mg Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
11214949|NCT02295774|EG000|Reported Event|MB MMX 200mg|"Biopsy samples collected during standard white light colonoscopy.~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks.~Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
11214950|NCT02295995|BG000|Baseline|Exercise|Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.
11214951|NCT02295995|BG001|Baseline|Usual Care Wait-List|Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
11214952|NCT02295995|BG002|Baseline|Total|Total of all reporting groups
11214953|NCT02295995|FG000|Participant Flow|Exercise|Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.
11214954|NCT02295995|FG001|Participant Flow|Usual Care Wait-List|Participants randomized to this arm continued to receive usual care services for PTSD through the Veterans Health Administration (VHA) for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
11214955|NCT02295995|OG000|Outcome|Eligible Patients|Number of potentially eligible patients contacted to participate in the study.
11214956|NCT02295995|OG000|Outcome|Exercise|Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.
11214957|NCT02295995|OG001|Outcome|Usual Care Wait-List|Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
11214958|NCT02295995|EG000|Reported Event|Exercise|Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. 36 patients were randomized, of which 31 completed the intervention (included in analyses).
11214959|NCT02295995|EG001|Reported Event|Usual Care Wait-List|Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks. 18 patients were randomized, of which 17 completed the study (included in analyses).
11214960|NCT02296099|BG000|Baseline|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214961|NCT02296099|BG001|Baseline|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214962|NCT02296099|BG002|Baseline|Total|Total of all reporting groups
11214963|NCT02296099|FG000|Participant Flow|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214964|NCT02296099|FG001|Participant Flow|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214965|NCT02296099|OG000|Outcome|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214966|NCT02296099|OG001|Outcome|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
11214967|NCT02296099|EG000|Reported Event|Liposomal Bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
11276833|NCT02772783|FG000|Participant Flow|High GI Matched Glucose - Low GI - High GI Matched Insulin|"In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage in the following order:~High GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.~- 1-week wash-out~Low GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia (comparison condition B); 1 day.~- 1-week wash-out~High GI meal with IV insulin matching the low GI meal, resulting in hyperglycemia (experimental condition C); 1 day.~High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.~Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration."
11276834|NCT02772783|FG001|Participant Flow|High GI Matched Insulin - Low GI - High GI Matched Glucose|"In a randomized cross-over design, a nutritional shake with high GI vs low GI was consumed with differential insulin coverage in the following order:~High GI meal with IV insulin matching the low GI meal (as determined during the pre-randomization visit), resulting in hyperglycemia (experimental condition C); 1 day.~- 1-week wash-out~Low GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia (comparison condition B); 1 day.~- 1-week wash-out~High GI meal covered with IV insulin adjusted using a negative feedback algorithm to achieve euglycemia, resulting in hyperinsulinemia (experimental condition A); 1 day.~High and low GI liquid test meals were matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals provided 25% of individual daily energy requirements.~Insulin was given intravenously for 5 hours. Glucose levels were measured every 5 minutes for insulin titration."
11276835|NCT02772783|OG000|Outcome|High GI With Matched to Low GI Glucose (HGI HI)|"After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.~Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention."
11276836|NCT02772783|OG001|Outcome|Low GI (LGI)|"After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia.~Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention."
11276837|NCT02772783|OG002|Outcome|High GI With Matched to Low GI Insulin (HGI LI)|"After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit.~Interventions were presented in a cross-over design. Because all participants completed all interventions, results are presented by intervention."
11276838|NCT02772783|EG000|Reported Event|High GI With Matched to Low GI Glucose (HGI HI)|"After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia."
11276839|NCT02772783|EG001|Reported Event|Low GI (LGI)|"After an overnight fast, a nutritional shake with low GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes, and Insulin was adjusted using a negative feedback algorithm to maintain euglycemia."
11286942|NCT02895360|EG000|Reported Event|Phase 1 - 30 mg/m² Cohort|BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
10820372|NCT00057577|EG000|Reported Event|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10822104|NCT00074490|FG002|Participant Flow|Arm IVA (12-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
11286943|NCT02895360|EG001|Reported Event|Phase 1 - 45 mg/m² Cohort|BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
10820373|NCT00057577|EG001|Reported Event|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
10820374|NCT00057681|BG000|Baseline|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
10820375|NCT00057681|BG001|Baseline|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
10820376|NCT00057681|BG002|Baseline|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
10820377|NCT00057681|BG003|Baseline|Total|Total of all reporting groups
10820378|NCT00057681|FG000|Participant Flow|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
10820379|NCT00057681|FG001|Participant Flow|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
10820380|NCT00057681|FG002|Participant Flow|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
10820381|NCT00057681|OG000|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
10820382|NCT00057681|OG001|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
10820383|NCT00057681|OG002|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
10820384|NCT00057681|EG000|Reported Event|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
10820385|NCT00057681|EG001|Reported Event|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
10970499|NCT00910845|BG000|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
11276840|NCT02772783|EG002|Reported Event|High GI With Matched to Low GI Insulin (HGI LI)|"After an overnight fast, a nutritional shake with high GI was consumed. The shake provided 25% of daily calorie requirements with a macronutrient composition of 60% carbohydrate, 15% protein, 25% fat, and matched micronutrient profiles, physical properties, palatability and sweetness.~Insulin was given intravenously to normalize blood glucose before the meal and for 5 hours postprandial. Blood glucose levels were measured every 5 minutes. Insulin was given at the same rates as determined appropriate for each participant during the pre-randomization visit or the LGI visit."
11276841|NCT02772809|BG000|Baseline|Subjects With Varying Levels of Motor Impairment|Subjects with varying levels of motor impairments who are ages 18 and older.
11276842|NCT02772809|FG000|Participant Flow|Stroke Survivors With Varying Levels of Motor Impairment|Stroke survivors with varying levels of motor deﬁcit impairment in their upper extremity.
11276843|NCT02772809|OG000|Outcome|Stroke Survivors With Motor Impairment|All subject used robot for tracking tasks
11276844|NCT02772809|OG000|Outcome|Subjects With Motor Impairment|Subjects with deﬁcit ages 18 and older.
11276845|NCT02772809|OG000|Outcome|Stroke Survivors With Motor Impairments|All subject used robot for tracking tasks
11276846|NCT02772809|OG000|Outcome|Subjects With Motor Impairment|Subjects completed tasks with robot and with clinical scale.
11276847|NCT02772809|OG000|Outcome|Subjects With Motor Impairments|Subjects with motor impairments who are ages 18 and older.
11276848|NCT02772809|OG000|Outcome|Stroke Survivors With Motor Impairments|All subject used robot for tracking tasks;
11276849|NCT02772809|EG000|Reported Event|Haptic Robot Therapy With Games|"Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback. 3) Assessments pre and post therapy.~Haptic Robot Therapy with Games: Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used. Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors."
11276850|NCT02772978|BG000|Baseline|Functional MRI Arm|"This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion~Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors~Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients"
11276851|NCT02772978|FG000|Participant Flow|Functional MRI Arm - Tolcapone, Then Placebo|"This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion~Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors~Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients"
11276852|NCT02772978|FG001|Participant Flow|Functional MRI Arm - Placebo, Then Tolcapone|"This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion~Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors~Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients"
11276853|NCT02772978|OG000|Outcome|Functional MRI Arm (Tolcapone and Placebo)|This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion. Tolcapone is a medication in the class of catechol-O-methyltransferase (COMT) inhibitors. A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients.
11276854|NCT02772978|EG000|Reported Event|Tolcapone Arm|"This cognitive science study consists of a single arm in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion~Tolcapone: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors~Placebo: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients."
11276855|NCT02772978|EG001|Reported Event|Placebo Arm|
11276856|NCT02773368|BG000|Baseline|IDegLira|Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276857|NCT02773368|BG001|Baseline|IGlar|Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276858|NCT02773368|BG002|Baseline|Total|Total of all reporting groups
11286944|NCT02895360|EG002|Reported Event|Phase 1 - 70 mg/m² Cohort|BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
10970500|NCT00910845|BG001|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970501|NCT00910845|BG002|Baseline|Total|Total of all reporting groups
11092313|NCT01539135|BG000|Baseline|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11214968|NCT02296099|EG001|Reported Event|Saline Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
10970502|NCT00910845|FG000|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970503|NCT00910845|FG001|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970504|NCT00910845|OG000|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970505|NCT00910845|OG001|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
10970506|NCT00910845|EG000|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
10970507|NCT00910845|EG001|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
11214969|NCT02296112|BG000|Baseline|Treatment (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214970|NCT02296112|FG000|Participant Flow|Treatment (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214971|NCT02296112|OG000|Outcome|"Treatment (Trametinib) High Activity"|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214972|NCT02296112|OG000|Outcome|Treatment (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214973|NCT02296112|OG000|Outcome|Treatment (Trametinib) Worst Grade 1|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214974|NCT02296112|OG001|Outcome|Worst Grade 2|Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
11214975|NCT02296112|OG002|Outcome|Worst Grade 3|Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in ...
11214976|NCT02296112|OG000|Outcome|Low Activity|Patients with low activity of BRAF mutations
11214977|NCT02296112|EG000|Reported Event|Treatment (Trametinib)|"Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~trametinib: Given PO~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
11214978|NCT02296138|BG000|Baseline|Tiotropium 5 Microgram (μg)|Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214979|NCT02296138|BG001|Baseline|Tiotropium (5 μg) + Olodaterol (5 μg)|Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214980|NCT02296138|BG002|Baseline|Total|Total of all reporting groups
11214981|NCT02296138|FG000|Participant Flow|Tiotropium 5 Microgram (μg)|Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214982|NCT02296138|FG001|Participant Flow|Tiotropium (5 μg) + Olodaterol (5 μg)|Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214983|NCT02296138|OG000|Outcome|Tiotropium 5 Microgram (μg)|Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214984|NCT02296138|OG001|Outcome|Tiotropium (5 μg) + Olodaterol (5 μg)|Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214985|NCT02296138|EG000|Reported Event|Tiotropium 5 Microgram (μg)|Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214986|NCT02296138|EG001|Reported Event|Tiotropium (5 μg) + Olodaterol (5 μg)|Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
11214987|NCT02296164|BG000|Baseline|MF-CTCL Patients Receiving Valchlor|"Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life.~Valchlor: Valchlor gel 0.016%"
10970508|NCT00910858|BG000|Baseline|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970509|NCT00910858|BG001|Baseline|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970510|NCT00910858|BG002|Baseline|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970511|NCT00910858|BG003|Baseline|Total|Total of all reporting groups
10970512|NCT00910858|FG000|Participant Flow|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970513|NCT00910858|FG001|Participant Flow|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11276859|NCT02773368|FG000|Participant Flow|IDegLira|Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276860|NCT02773368|FG001|Participant Flow|IGlar|Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
10970514|NCT00910858|FG002|Participant Flow|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11276861|NCT02773368|OG000|Outcome|IDegLira|Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276862|NCT02773368|OG001|Outcome|IGlar|Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276863|NCT02773368|EG000|Reported Event|IDegLira|Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276864|NCT02773368|EG001|Reported Event|IGlar|Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
11276865|NCT02773446|BG000|Baseline|Cohort 1 Group A|"8 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276866|NCT02773446|BG001|Baseline|Cohort 1 Group B|"9 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276867|NCT02773446|BG002|Baseline|Cohort 1 Group C|"9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276868|NCT02773446|BG003|Baseline|Cohort 1 Group D|"10 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276869|NCT02773446|BG004|Baseline|Cohort 2 Group A|"subjects from Cohort 1 who met primary endpoint - 9 logs of E.coli strain B7A~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276870|NCT02773446|BG005|Baseline|Cohort 2 Group B|"Naive subjects - 9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276871|NCT02773446|BG006|Baseline|Total|Total of all reporting groups
11276872|NCT02773446|FG000|Participant Flow|Cohort 1 Group A|"Volunteers will receive 8 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276873|NCT02773446|FG001|Participant Flow|Cohort 1 Group B|"Volunteers will receive 9 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276874|NCT02773446|FG002|Participant Flow|Cohort 1 Group C|"Volunteers will receive 9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276875|NCT02773446|FG003|Participant Flow|Cohort 1 Group D|"Volunteers will receive 10 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276876|NCT02773446|FG004|Participant Flow|Cohort 2 Group A|"subjects from Cohort 1 who met primary endpoint will receive optimal regimen as determined by analysis after Cohort 1.~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276877|NCT02773446|FG005|Participant Flow|Cohort 2 Group B|"Naive subjects who will receive optimal regimen as determined by analysis after Cohort 1~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276878|NCT02773446|OG000|Outcome|Cohort 1 Group A|"8 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276879|NCT02773446|OG001|Outcome|Cohort 1 Group B|"9 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276880|NCT02773446|OG002|Outcome|Cohort 1 Group C|"9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
10970515|NCT00910858|OG000|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
11214988|NCT02296164|FG000|Participant Flow|MF-CTCL Patients Receiving Valchlor|"Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient-completed questionnaires for symptoms and QOL, there were no specific or mandated clinical assessments performed, and patients did not receive experimental intervention or treatment as a consequence of their participation in this study. Continuation in the study was not contingent on continuation of Valchlor.~Valchlor: Valchlor gel 0.016%"
11214989|NCT02296164|OG000|Outcome|MF-CTCL Patients Receiving Valchlor|"Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life.~Valchlor: Valchlor gel 0.016%"
11214990|NCT02296164|EG000|Reported Event|MF-CTCL Patients Receiving Valchlor|"Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life.~Valchlor: Valchlor gel 0.016%"
11214991|NCT02296190|BG000|Baseline|Etripamil_140 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214992|NCT02296190|BG001|Baseline|Etripamil_105 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214993|NCT02296190|BG002|Baseline|Etripamil_70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214994|NCT02296190|BG003|Baseline|Etripamil_35 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214995|NCT02296190|BG004|Baseline|Placebo|1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214996|NCT02296190|BG005|Baseline|Open- Label Etripamil 70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214997|NCT02296190|BG006|Baseline|Total|Total of all reporting groups
11214998|NCT02296190|FG000|Participant Flow|Etripamil_140 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11214999|NCT02296190|FG001|Participant Flow|Etripamil_ 105 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215000|NCT02296190|FG002|Participant Flow|Etripamil_70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215001|NCT02296190|FG003|Participant Flow|Etripamil_35 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215002|NCT02296190|FG004|Participant Flow|Placebo|1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215003|NCT02296190|FG005|Participant Flow|Open-label Etripamil 70 mg|9 subjects were assigned to an open-label Sub-study Safety Population. Subjects participating in the open-label sub-study received intra nasal administration of 70 mg MSP-2017 (total) via 2 prefilled Aptar Pharma Unit-Dose Spray devices.
11215004|NCT02296190|OG000|Outcome|Etripamil_140 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215005|NCT02296190|OG001|Outcome|Etripamil_ 105 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215006|NCT02296190|OG002|Outcome|Etripamil_70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215007|NCT02296190|OG003|Outcome|Etripamil_35 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215008|NCT02296190|OG004|Outcome|Placebo|1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215009|NCT02296190|EG000|Reported Event|Etripamil_140 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215010|NCT02296190|EG001|Reported Event|Etripamil_105 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215011|NCT02296190|EG002|Reported Event|Etripamil_70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215012|NCT02296190|EG003|Reported Event|Etripamil_35 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215013|NCT02296190|EG004|Reported Event|Placebo|1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215014|NCT02296190|EG005|Reported Event|Open Label Etripamil 70 mg|1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
11215015|NCT02296242|BG000|Baseline|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215016|NCT02296242|BG001|Baseline|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215017|NCT02296242|BG002|Baseline|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215018|NCT02296242|BG003|Baseline|Cohort-expansion RAS(+) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11276881|NCT02773446|OG003|Outcome|Cohort 1 Group D|"10 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276882|NCT02773446|OG004|Outcome|Cohort 2 Group A|"subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276883|NCT02773446|OG005|Outcome|Cohort 2 Group B|"Naive subjects - 9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276884|NCT02773446|OG004|Outcome|Cohort 2 Group A|subjects from Cohort 1 who met primary endpoint- 9 logs of E. coli strain B7A after overnight fast
11276885|NCT02773446|OG005|Outcome|Cohort 2 Group B|"Naive subjects -9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276886|NCT02773446|OG000|Outcome|Cohort 2 Group A|"subjects from Cohort 1 who met primary endpoint 9 logs of E.coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276887|NCT02773446|EG000|Reported Event|Cohort 1 Group A|"8 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276888|NCT02773446|EG001|Reported Event|Cohort 1 Group B|"9 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276889|NCT02773446|EG002|Reported Event|Cohort 1 Group C|"9 logs of E. coli strain B7A after overnight fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276890|NCT02773446|EG003|Reported Event|Cohort 1 Group D|"10 logs of E. coli strain B7A after 90 minute fast~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276891|NCT02773446|EG004|Reported Event|Cohort 2 Group A|"subjects from Cohort 1 who met primary endpoint will receive optimal regimen as determined by analysis after Cohort 1.~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276892|NCT02773446|EG005|Reported Event|Cohort 2 Group B|"Naive subjects who will receive optimal regimen as determined by analysis after Cohort 1~ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer: ETEC Bacteria"
11276893|NCT02773537|BG000|Baseline|Femoral Nerve Catheter and Sciatic Nerve Block|"Femoral nerve catheter and sciatic nerve block~Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb."
11276894|NCT02773537|BG001|Baseline|Adductor Canal Catheter and Selective Tibial Block|"Adductor canal catheter and selective tibial block~Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb."
11276895|NCT02773537|BG002|Baseline|Adductor Canal Catheter Only|"Adductor canal catheter only~Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb"
11276896|NCT02773537|BG003|Baseline|Total|Total of all reporting groups
11276897|NCT02773537|FG000|Participant Flow|Femoral Nerve Catheter and Sciatic Nerve Block|"Femoral nerve catheter and sciatic nerve block~Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb."
11276898|NCT02773537|FG001|Participant Flow|Adductor Canal Catheter and Selective Tibial Block|"Adductor canal catheter and selective tibial block~Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb."
11276899|NCT02773537|FG002|Participant Flow|Adductor Canal Catheter Only|"Adductor canal catheter only~Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb"
11276900|NCT02773537|OG000|Outcome|Femoral Nerve Catheter and Sciatic Nerve Block|"Femoral nerve catheter and sciatic nerve block~Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb."
11276901|NCT02773537|OG001|Outcome|Adductor Canal Catheter and Selective Tibial Block|"Adductor canal catheter and selective tibial block~Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb."
11276902|NCT02773537|OG002|Outcome|Adductor Canal Catheter Only|"Adductor canal catheter only~Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb"
11276903|NCT02773537|EG000|Reported Event|Femoral Nerve Catheter and Sciatic Nerve Block|"Femoral nerve catheter and sciatic nerve block~Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb."
11276904|NCT02773537|EG001|Reported Event|Adductor Canal Catheter and Selective Tibial Block|"Adductor canal catheter and selective tibial block~Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb."
11276905|NCT02773537|EG002|Reported Event|Adductor Canal Catheter Only|"Adductor canal catheter only~Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb"
11276906|NCT02773758|BG000|Baseline|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
11276907|NCT02773758|BG001|Baseline|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
11276908|NCT02773758|BG002|Baseline|Total|Total of all reporting groups
11276909|NCT02773758|FG000|Participant Flow|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
11276910|NCT02773758|FG001|Participant Flow|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
11276911|NCT02773758|OG000|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
11276912|NCT02773758|OG001|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
11276913|NCT02773758|EG000|Reported Event|Stannous Fluoride Dentifrice|Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
11276914|NCT02773758|EG001|Reported Event|Sodium Monofluorophosphate Dentifrice|Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
11276915|NCT02773836|BG000|Baseline|Greek Cohort|"Participants recruited from Greece~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11092314|NCT01539135|BG001|Baseline|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11276916|NCT02773836|BG001|Baseline|German Cohort|"Participants recruited from Germany~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276917|NCT02773836|BG002|Baseline|Romanian Cohort|"Participants recruited from Romania~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276918|NCT02773836|BG003|Baseline|Spanish Cohort|"Participants recruited from Spain~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276919|NCT02773836|BG004|Baseline|Hungarian Cohort|"Participants recruited from Hungary~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276920|NCT02773836|BG005|Baseline|Polish Cohort|"Participants recruited from Poland~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276921|NCT02773836|BG006|Baseline|Total|Total of all reporting groups
11276922|NCT02773836|FG000|Participant Flow|Greek Cohort|"Participants recruited from Greece~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276923|NCT02773836|FG001|Participant Flow|German Cohort|"Participants recruited from Germany~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276924|NCT02773836|FG002|Participant Flow|Romanian Cohort|"Participants recruited from Romania~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11092315|NCT01539135|BG002|Baseline|Total|Total of all reporting groups
11276925|NCT02773836|FG003|Participant Flow|Spanish Cohort|"Participants recruited from Spain~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276926|NCT02773836|FG004|Participant Flow|Hungarian Cohort|"Participants recruited from Hungary~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276927|NCT02773836|FG005|Participant Flow|Polish Cohort|"Participants recruited from Poland~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276928|NCT02773836|OG000|Outcome|Greek Cohort|"Participants recruited from Greece~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276929|NCT02773836|OG001|Outcome|German Cohort|"Participants recruited from Germany~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276930|NCT02773836|OG002|Outcome|Romanian Cohort|"Participants recruited from Romania~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276931|NCT02773836|OG003|Outcome|Spanish Cohort|"Participants recruited from Spain~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276932|NCT02773836|OG004|Outcome|Hungarian Cohort|"Participants recruited from Hungary~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276933|NCT02773836|OG005|Outcome|Polish Cohort|"Participants recruited from Poland~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276934|NCT02773836|OG000|Outcome|Greek Cohort|"Participants recruited from Greece will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276935|NCT02773836|OG001|Outcome|German Cohort|"Participants recruited from Germany will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276936|NCT02773836|OG002|Outcome|Romanian Cohort|"Participants recruited from Romania will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276937|NCT02773836|OG003|Outcome|Spanish Cohort|"Participants recruited from Spain will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276938|NCT02773836|OG004|Outcome|Hungarian Cohort|"Participants recruited from Hungary will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276939|NCT02773836|OG005|Outcome|Polish Cohort|"Participants recruited from Poland will receive a questionnaire at pre- and post- intervention~Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)"
11276940|NCT02773836|EG000|Reported Event|Greek Cohort|Participants recruited from Greece Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
11276941|NCT02773836|EG001|Reported Event|German Cohort|Participants recruited from Germany Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
10970516|NCT00910858|OG000|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
11276942|NCT02773836|EG002|Reported Event|Romanian Cohort|Participants recruited from Romania Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
11276943|NCT02773836|EG003|Reported Event|Spanish Cohort|Participants recruited from Spain Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
11276944|NCT02773836|EG004|Reported Event|Hungarian Cohort|Participants recruited from Hungary Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
11276945|NCT02773836|EG005|Reported Event|Polish Cohort|Participants recruited from Poland Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
11276946|NCT02774213|BG000|Baseline|Cancer-Induced Bone Pain (CIBP)|Cancer patients with bone metastasis suffering from pain
11276947|NCT02774213|FG000|Participant Flow|Cancer-Induced Bone Pain (CIBP)|Cancer patients with bone metastasis suffering from pain
11276948|NCT02774213|OG000|Outcome|Cancer-Induced Bone Pain (CIBP)|Cancer patients with bone metastasis suffering from pain
11276949|NCT02774213|EG000|Reported Event|Cancer-Induced Bone Pain (CIBP)|cancer patients with bone metastasis suffering from pain
11276950|NCT02774226|BG000|Baseline|Tetrahydrobiopterin (BH4)|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following, 5mg/kg, 10mg/kg, or 20mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.~Tetrahydrobiopterin (BH4): 12 week intervention"
11276951|NCT02774226|BG001|Baseline|Antioxidant Cocktail|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.~Antioxidant Cocktail: 12 week intervention"
11276952|NCT02774226|BG002|Baseline|Total|Total of all reporting groups
11276953|NCT02774226|FG000|Participant Flow|Tetrahydrobiopterin (BH4)|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following, 5mg/kg, 10mg/kg, or 20mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.~Tetrahydrobiopterin (BH4): 12 week intervention"
11276954|NCT02774226|FG001|Participant Flow|Antioxidant Cocktail|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.~Antioxidant Cocktail: 12 week intervention"
11276955|NCT02774226|OG000|Outcome|Tetrahydrobiopterin (BH4)|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following, 5mg/kg, 10mg/kg, or 20mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.~Tetrahydrobiopterin (BH4): 12 week intervention"
11276956|NCT02774226|OG001|Outcome|Antioxidant Cocktail|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.~Antioxidant Cocktail: 12 week intervention"
11276957|NCT02774226|EG000|Reported Event|Tetrahydrobiopterin (BH4)|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following 5mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.~Tetrahydrobiopterin (BH4): 12 week intervention"
11276958|NCT02774226|EG001|Reported Event|Antioxidant Cocktail|"Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.~Antioxidant Cocktail: 12 week intervention"
11276959|NCT02774278|BG000|Baseline|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
11276960|NCT02774278|FG000|Participant Flow|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
11276961|NCT02774278|OG000|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
11276962|NCT02774278|EG000|Reported Event|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
11276963|NCT02774343|BG000|Baseline|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276964|NCT02774343|BG001|Baseline|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276965|NCT02774343|BG002|Baseline|Total|Total of all reporting groups
11276966|NCT02774343|FG000|Participant Flow|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276967|NCT02774343|FG001|Participant Flow|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276968|NCT02774343|OG000|Outcome|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276969|NCT02774343|OG001|Outcome|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276970|NCT02774343|EG000|Reported Event|Pioglitazone + Therapy + Contingency Management|"Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276971|NCT02774343|EG001|Reported Event|Placebo + Therapy + Contingency Management|"Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.~Therapy: Cognitive-behavioral therapy 1 hour per week~Contingency Management: Prize-based contingency management for attendance"
11276972|NCT02774616|BG000|Baseline|Ilivia ICD Family|"Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting~Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule"
11276973|NCT02774616|BG001|Baseline|Plexa ICD Lead|"Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting~Plexa ICD lead: predefined follow-up schedule"
11276974|NCT02774616|BG002|Baseline|Ilivia ICD and Plexa ICD Lead|"Implant of the new Ilivia ICD Family and the new Plexa ICD lead. Device measurements, pre-defined programming and Adverse Event Reporting~Pre-defined device programming, measurements and follow-up schedule"
11276975|NCT02774616|BG003|Baseline|Total|Total of all reporting groups
11276976|NCT02774616|FG000|Participant Flow|Ilivia ICD Family|"Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting~Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule"
11276977|NCT02774616|FG001|Participant Flow|Plexa ICD Lead|"Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting~Plexa ICD lead: predefined follow-up schedule"
11276978|NCT02774616|FG002|Participant Flow|Ilivia ICD and Plexa ICD Lead|Implant of the new Ilivia ICD and the new Plexa ICD lead
11276979|NCT02774616|OG000|Outcome|Ilivia Arm|This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
11276980|NCT02774616|OG001|Outcome|Ilivia ICD and Plexa ICD Lead|This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
11276981|NCT02774616|OG000|Outcome|Plexa Arm|This endpoint was evaluated in patients of the Plexa arm and of the Ilivia ICD and Plexa ICD lead arm combined
11276982|NCT02774616|OG001|Outcome|Ilivia ICD and Plexa ICD Lead|This endpoint was evaluated in patients of the Plexa arm and of the Ilivia ICD and Plexa ICD lead arm combined
11276983|NCT02774616|OG000|Outcome|Ilivia Arm|This endpoint was evaluated in patients of the Iliva arm with spontaneous ventricular arrhythmia detected in the VF zone
11276984|NCT02774616|OG000|Outcome|Plexa Arm|This endpoint was evaluated in patients of the Plexa arm only
11276985|NCT02774616|EG000|Reported Event|Ilivia ICD Family|"Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting~Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule"
11276986|NCT02774616|EG001|Reported Event|Plexa ICD Lead|"Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting~Plexa ICD lead: predefined follow-up schedule"
11276987|NCT02774681|BG000|Baseline|Treatment (Palbociclib)|"Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks.~Cognitive Assessment: Ancillary studies~Palbociclib: Given PO~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11276988|NCT02774681|FG000|Participant Flow|Treatment (Palbociclib)|"Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks.~Cognitive Assessment: Ancillary studies~Palbociclib: Given PO~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11276989|NCT02774681|OG000|Outcome|Treatment (Palbociclib)|"Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks.~Cognitive Assessment: Ancillary studies~Palbociclib: Given PO~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11276990|NCT02774681|EG000|Reported Event|Treatment (Palbociclib)|"Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks.~Cognitive Assessment: Ancillary studies~Palbociclib: Given PO~Quality-of-Life Assessment: Ancillary studies~Trastuzumab: Given IV"
11276991|NCT02774798|BG000|Baseline|Intra-rectal Intussusception (Oxford Groups 1 &2)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276992|NCT02774798|BG001|Baseline|Intra-anal Intussusception (Oxford Grades 3 & 4)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276993|NCT02774798|BG002|Baseline|Overt Rectal Prolapse (Oxford Garde 5)|Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse
11276994|NCT02774798|BG003|Baseline|Total|Total of all reporting groups
11276995|NCT02774798|FG000|Participant Flow|Intra-rectal Intussusception (Oxford Groups 1 &2)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276996|NCT02774798|FG001|Participant Flow|Intra-anal Intussusception (Oxford Grades 3 & 4)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276997|NCT02774798|FG002|Participant Flow|Overt Rectal Prolapse (Oxford Grade 5)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276998|NCT02774798|OG000|Outcome|Intra-rectal Intussusception (Oxford Groups 1 &2)|Patients grade of rectal prolapse depending on Oxford grading criteria
11276999|NCT02774798|OG001|Outcome|Intra-anal Intussusception (Oxford Grades 3 & 4)|Patients grade of rectal prolapse depending on Oxford grading criteria
11277000|NCT02774798|OG002|Outcome|Overt Rectal Prolapse (Oxford Grade 5)|Patients grade of rectal prolapse depending on Oxford grading criteria
11277001|NCT02774798|EG000|Reported Event|Intra-rectal Intussusception (Oxford Groups 1 &2)|Patients grade of rectal prolapse depending on Oxford grading criteria
11277002|NCT02774798|EG001|Reported Event|Intra-anal Intussusception (Oxford Grades 3 & 4)|Patients grade of rectal prolapse depending on Oxford grading criteria
11277003|NCT02774798|EG002|Reported Event|Overt Rectal Prolapse (Oxford Garde 5)|Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse
11277004|NCT02774850|BG000|Baseline|Early Discharge Management|Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
11277005|NCT02774850|BG001|Baseline|Inpatient Management|Remain hospitalized during chemotherapy-induced neutropenia
11277006|NCT02774850|BG002|Baseline|Total|Total of all reporting groups
11277007|NCT02774850|FG000|Participant Flow|Pediatric AML Patients|All patients included in chart abstractions. Exclusion criteria were applied to these patients to determine if they were early discharge eligible. Then they were assigned to outpatient-managed and inpatient-managed arms.
11277008|NCT02774850|OG000|Outcome|Early Discharge Management|Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
11277009|NCT02774850|OG001|Outcome|Inpatient Management|Remain hospitalized during chemotherapy-induced neutropenia
11277010|NCT02774850|EG000|Reported Event|Early Discharge Management|Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
11277011|NCT02774850|EG001|Reported Event|Inpatient Management|Remain hospitalized during chemotherapy-induced neutropenia
11277012|NCT02774941|BG000|Baseline|Control - Jet Nebulizer|The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
11277013|NCT02774941|BG001|Baseline|Study - Vibrating Mesh Nebulizer|The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
11277014|NCT02774941|BG002|Baseline|Total|Total of all reporting groups
11277015|NCT02774941|FG000|Participant Flow|Control - Jet Nebulizer|The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
11277016|NCT02774941|FG001|Participant Flow|Study - Vibrating Mesh Nebulizer|The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
11277017|NCT02774941|OG000|Outcome|Control - Jet Nebulizer|The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
11277018|NCT02774941|OG001|Outcome|Study - Vibrating Mesh Nebulizer|The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
11277019|NCT02774941|EG000|Reported Event|Control - Jet Nebulizer|The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
11277020|NCT02774941|EG001|Reported Event|Study - Vibrating Mesh Nebulizer|The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
11277021|NCT02775240|BG000|Baseline|Treatment A and B|On Day 1, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin and a single 30 mg (2 x 15 mg) oral dose of dextromethorphan (Treatment A) followed by a wash out period of minimum 7 days until start of treatment B, during which participants received maribavir 400 mg (2 x 200 mg) orally twice daily from Day 8 to Day 15. On Day 13, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin and a single 30 mg (2 × 15 mg) oral dose of dextromethorphan co-administered with the morning dose of maribavir. The test product, maribavir and the investigational products, digoxin and dextromethorphan, were provided in the form of tablet.
11277022|NCT02775240|FG000|Participant Flow|Treatment A and B|On Day 1, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin and a single 30 mg (2 x 15 mg) oral dose of dextromethorphan (Treatment A) followed by a wash out period of minimum 7 days until start of treatment B, during which participants received maribavir 400 mg (2 x 200 mg) orally twice daily from Day 8 to Day 15. On Day 13, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin and a single 30 mg (2 × 15 mg) oral dose of dextromethorphan co-administered with the morning dose of maribavir. The test product, maribavir and the investigational products, digoxin and dextromethorphan, were provided in the form of tablet.
11277023|NCT02775240|OG000|Outcome|Treatment A|Participants received a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin tablet and a single 30 mg (2 x 15 mg) oral dose of dextromethorphan tablet on Day 1.
11277024|NCT02775240|OG001|Outcome|Treatment B|Participants received maribavir 400 mg (2 x 200 mg) tablet orally twice daily from Day 8 to Day 15. On Day 13, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin tablet and a single 30 mg (2 × 15 mg) oral dose of dextromethorphan tablet co-administered with the morning dose of maribavir.
11277025|NCT02775240|OG000|Outcome|Treatment B|Participants received maribavir 400 mg (2 x 200 mg) tablet orally twice daily from Day 8 to Day 15. On Day 13, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin tablet and a single 30 mg (2 × 15 mg) oral dose of dextromethorphan tablet co-administered with the morning dose of maribavir.
11277026|NCT02775240|EG000|Reported Event|Treatment A|Participants received a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin tablet and a single 30 mg (2 x 15 mg) oral dose of dextromethorphan tablet on Day 1.
11277027|NCT02775240|EG001|Reported Event|Treatment B|Participants received maribavir 400 mg (2 x 200 mg) tablet orally twice daily from Day 8 to Day 15. On Day 13, participants received a single 0.5 mg (2 × 0.25 mg) oral dose of digoxin tablet and a single 30 mg (2 × 15 mg) oral dose of dextromethorphan tablet co-administered with the morning dose of maribavir.
11277028|NCT02775344|BG000|Baseline|Three Dimension Laparoscopy|"This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.~Three dimension laparoscopy: Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy."
11277029|NCT02775344|BG001|Baseline|Two Dimension Laparoscopy|Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
11277030|NCT02775344|BG002|Baseline|Total|Total of all reporting groups
11277031|NCT02775344|FG000|Participant Flow|Three Dimension Laparoscopy|"This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.~Three dimension laparoscopy: Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy."
11277032|NCT02775344|FG001|Participant Flow|Two Dimension Laparoscopy|Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
11277033|NCT02775344|OG000|Outcome|Three Dimension Laparoscopy|"This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.~Three dimension laparoscopy: Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy."
11277034|NCT02775344|OG001|Outcome|Two Dimension Laparoscopy|Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
11277035|NCT02775344|EG000|Reported Event|Three Dimension Laparoscopy|"This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.~Three dimension laparoscopy: Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy."
11277036|NCT02775344|EG001|Reported Event|Two Dimension Laparoscopy|Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
11277037|NCT02775617|BG000|Baseline|Parallel Treatment|"Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277038|NCT02775617|BG001|Baseline|Sequential Treatment|"Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..~Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277039|NCT02775617|BG002|Baseline|Total|Total of all reporting groups
11277040|NCT02775617|FG000|Participant Flow|Parallel Treatment|"Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277041|NCT02775617|FG001|Participant Flow|Sequential Treatment|"Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..~Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277042|NCT02775617|OG000|Outcome|Parallel Treatment|"Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277043|NCT02775617|OG001|Outcome|Sequential Treatment|"Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..~Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277044|NCT02775617|EG000|Reported Event|Parallel Treatment|"Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277045|NCT02775617|EG001|Reported Event|Sequential Treatment|"Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..~Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.~Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.~Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.~Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead."
11277046|NCT02775864|BG000|Baseline|Antipsychotic|"Individuals initiating treatment with an antipsychotic medication~Antipsychotic: New initiation of any antipsychotic medication"
11277047|NCT02775864|BG001|Baseline|Antidepressant|"Individuals initiating treatment with an antidepressant medication~Antidepressant: New initiation of any antidepressant medications"
11277048|NCT02775864|BG002|Baseline|Benzodiazepine|"Individuals initiating treatment with a benzodiazepine~Benzodiazepine: New initiation of any benzodiazepine"
11277049|NCT02775864|BG003|Baseline|Mood Stabilizer|"Individuals initiating treatment with a mood stabilizer~Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug"
11277050|NCT02775864|BG004|Baseline|Total|Total of all reporting groups
11277051|NCT02775864|FG000|Participant Flow|Antipsychotic|"Individuals initiating treatment with an antipsychotic medication~Antipsychotic: New initiation of any antipsychotic medication"
11277052|NCT02775864|FG001|Participant Flow|Antidepressant|"Individuals initiating treatment with an antidepressant medication~Antidepressant: New initiation of any antidepressant medications"
11277053|NCT02775864|FG002|Participant Flow|Benzodiazepine|"Individuals initiating treatment with a benzodiazepine~Benzodiazepine: New initiation of any benzodiazepine"
11277054|NCT02775864|FG003|Participant Flow|Mood Stabilizer|"Individuals initiating treatment with a mood stabilizer~Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug"
11277055|NCT02775864|OG000|Outcome|Antipsychotic|Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine
11277056|NCT02775864|OG001|Outcome|Antidepressant|Individuals initiating treatment with an antidepressant medication
11277057|NCT02775864|OG002|Outcome|Benzodiazepine|Individuals initiating treatment with a benzodiazepine
11277058|NCT02775864|OG003|Outcome|Mood Stabilizer|Individuals initiating treatment with a mood stabilizer
11277059|NCT02775864|OG000|Outcome|Antipsychotic|Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine)
11277060|NCT02775864|EG000|Reported Event|Antipsychotic|Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine)
11277061|NCT02775864|EG001|Reported Event|Antidepressant|Individuals initiating treatment with an antidepressant medication
11277062|NCT02775864|EG002|Reported Event|Benzodiazepine|Individuals initiating treatment with a benzodiazepine
11277063|NCT02775864|EG003|Reported Event|Mood Stabilizer|Individuals initiating treatment with a mood stabilizer
11277064|NCT02775916|BG000|Baseline|CDZ173|Capsule BID
11277065|NCT02775916|BG001|Baseline|Placebo|Capsule matching Placebo BID
11277066|NCT02775916|BG002|Baseline|Total|Total of all reporting groups
11277067|NCT02775916|FG000|Participant Flow|CDZ173|Capsule BID
11277068|NCT02775916|FG001|Participant Flow|Placebo|Capsule matching Placebo BID
11277069|NCT02775916|OG000|Outcome|CDZ173|Capsule BID
11277070|NCT02775916|OG001|Outcome|Placebo|Capsule matching Placebo BID
11277071|NCT02775916|EG000|Reported Event|CDZ173|Capsule BID
11277072|NCT02775916|EG001|Reported Event|Placebo|Capsule matching Placebo BID
11277073|NCT02776033|BG000|Baseline|Placebo|Eligible participants received placebo orally BID, for 12 weeks in Cohort 1 and orally TID for 12 weeks in Cohort 2 of the study.
11277074|NCT02776033|BG001|Baseline|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277075|NCT02776033|BG002|Baseline|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11277076|NCT02776033|BG003|Baseline|Total|Total of all reporting groups
11277077|NCT02776033|FG000|Participant Flow|Placebo|Eligible participants received placebo orally BID, for 12 weeks in Cohort 1 and orally TID for 12 weeks in Cohort 2 of the study.
11277078|NCT02776033|FG001|Participant Flow|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277079|NCT02776033|FG002|Participant Flow|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11277080|NCT02776033|OG000|Outcome|Placebo|Eligible participants received placebo orally BID, for 12 weeks in Cohort 1 and orally TID for 12 weeks in Cohort 2 of the study.
11277081|NCT02776033|OG001|Outcome|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277082|NCT02776033|OG002|Outcome|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11277083|NCT02776033|OG000|Outcome|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277084|NCT02776033|OG001|Outcome|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11277085|NCT02776033|OG000|Outcome|Placebo BID|Eligible participants received placebo BID, oral tablet in Cohort 1 of the study for 12 Weeks.
11277086|NCT02776033|OG001|Outcome|Placebo TID|Eligible participants received placebo TID, oral tablet in Cohort 2 of the study for 12 Weeks.
11277087|NCT02776033|OG002|Outcome|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277088|NCT02776033|OG003|Outcome|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11277089|NCT02776033|EG000|Reported Event|Placebo|Eligible participants received placebo orally BID, for 12 weeks in Cohort 1 and orally TID for 12 weeks in Cohort 2 of the study.
11277090|NCT02776033|EG001|Reported Event|GSK2982772 60 mg BID|Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study.
11277091|NCT02776033|EG002|Reported Event|GSK2982772 60 mg TID|Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study.
11286945|NCT02895360|EG003|Reported Event|Phase 1 - 90 mg/m² Cohort|BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
11286946|NCT02895360|EG004|Reported Event|Phase 2a - Ovarian Cancer Cohort|BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
11286947|NCT02895360|EG005|Reported Event|Phase 2a - Recurrent Glioblastoma Cohort|BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
11277092|NCT02776553|BG000|Baseline|Active (Physical Training Program)|"physical activity + behavioral therapy + nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids~Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.~Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits."
11277093|NCT02776553|BG001|Baseline|Control|"nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids"
11277094|NCT02776553|BG002|Baseline|Total|Total of all reporting groups
11277095|NCT02776553|FG000|Participant Flow|Active (Physical Training Program)|"physical activity + behavioral therapy + nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids~Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.~Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits."
11277096|NCT02776553|FG001|Participant Flow|Control|"nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids"
11277097|NCT02776553|OG000|Outcome|Active (Physical Training Program)|"physical activity + behavioral therapy + nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids~Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.~Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits."
11277098|NCT02776553|OG001|Outcome|Control|"nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids"
11277099|NCT02776553|EG000|Reported Event|Active (Physical Training Program)|"physical activity + behavioral therapy + nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids~Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.~Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits."
11277100|NCT02776553|EG001|Reported Event|Control|"nutritional intervention~Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids"
11277101|NCT02776644|BG000|Baseline|Sunitinib|Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.
11277102|NCT02776644|BG001|Baseline|Pazopanib|Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
11277103|NCT02776644|BG002|Baseline|Total|Total of all reporting groups
11277104|NCT02776644|FG000|Participant Flow|Sunitinib|Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.
11277105|NCT02776644|FG001|Participant Flow|Pazopanib|Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
11277106|NCT02776644|OG000|Outcome|Sunitinib|Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.
11277107|NCT02776644|OG001|Outcome|Pazopanib|Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
11277108|NCT02776644|EG000|Reported Event|Sunitinib|Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.
11277109|NCT02776644|EG001|Reported Event|Pazopanib|Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
11277110|NCT02776670|BG000|Baseline|SYSTANE BALANCE|Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
11277111|NCT02776670|BG001|Baseline|REFRESH OPTIVE|Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
11277112|NCT02776670|BG002|Baseline|Total|Total of all reporting groups
11277113|NCT02776670|FG000|Participant Flow|SYSTANE BALANCE|Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
11277114|NCT02776670|FG001|Participant Flow|REFRESH OPTIVE|Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
11277115|NCT02776670|OG000|Outcome|SYSTANE BALANCE|Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
11277116|NCT02776670|OG001|Outcome|REFRESH OPTIVE|Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
11277117|NCT02776670|EG000|Reported Event|SYSTANE BALANCE|All subjects exposed to SYSTANE® BALANCE
11277118|NCT02776670|EG001|Reported Event|REFRESH OPTIVE|All subjects exposed to REFRESH OPTIVE®
11277119|NCT02776683|BG000|Baseline|BI 695502|All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients.
11277120|NCT02776683|FG000|Participant Flow|BI 695502|All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients.
11277121|NCT02776683|FG001|Participant Flow|BI 695502 to Avastin®|At the switch visit, patients were to be switched from BI 695502 to Avastin®. Post-switch, patients were to receive Avastin® (5 mg/kg) solution for i.v. infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier.
11277122|NCT02776683|OG000|Outcome|BI 695502|All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients.
11277123|NCT02776683|EG000|Reported Event|BI 695502|All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients.
11277124|NCT02776774|BG000|Baseline|Intra-wound Antibiotics (IWA) Knowledge and Use|Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
11277125|NCT02776774|FG000|Participant Flow|Intra-wound Antibiotics (IWA) Knowledge and Use|Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
11277126|NCT02776774|OG000|Outcome|Intra-wound Antibiotics (IWA) Knowledge and Use|Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
11277127|NCT02776774|EG000|Reported Event|Intra-wound Antibiotics (IWA) Knowledge and Use|Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
11277128|NCT02776904|BG000|Baseline|Healthy Athletes|Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.
11277129|NCT02776904|BG001|Baseline|Concussed Athletes|Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.
11277130|NCT02776904|BG002|Baseline|Total|Total of all reporting groups
11277131|NCT02776904|FG000|Participant Flow|Healthy Athletes|Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.
11277132|NCT02776904|FG001|Participant Flow|Concussed Athletes|Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.
11277133|NCT02776904|OG000|Outcome|Healthy Athlete IMPACT Score|"Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.~Immediate Post-concussion Assessment and Cognitive Testing"
11286948|NCT02895945|BG000|Baseline|Major Surgeries|Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11277134|NCT02776904|OG000|Outcome|Gait Assessment- Velocity|Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); step length (cm); DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground; and SLS, defined as the %GC weight bearing through a single limb.
11277135|NCT02776904|OG000|Outcome|Gait Assessment|Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: step length (cm)
11277136|NCT02776904|OG000|Outcome|Gait Assessment- DLS|Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); step length (cm); DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground; and SLS, defined as the %GC weight bearing through a single limb.
11277137|NCT02776904|OG000|Outcome|Gait Assessment- SLS Healthy Athlete|Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: SLS, defined as the %GC weight bearing through a single limb.
11277138|NCT02776904|OG000|Outcome|Y Balance Data|Y balance data anterior reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance.
11277139|NCT02776904|OG000|Outcome|Y Balance Data|Y balance data posterolateral reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance in the posterolateral direction.
11277140|NCT02776904|OG000|Outcome|Y Balance Data|Y balance data postero-medial reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance.
11277141|NCT02776904|OG000|Outcome|Healthy Athlete PVT Score|PVT testing will occur during a session of baseline testing in healthy male athletes who are participating in high school sports.
11277142|NCT02776904|EG000|Reported Event|Healthy Athletes|Healthy athletes were assessed using Gait analysis, balance, and ImPACT in their schools.
11277143|NCT02776904|EG001|Reported Event|Concussed Athletes|concussed athletes were assessed using Gait Analysis, balance, and IMPACT.
11277144|NCT02777021|BG000|Baseline|Early Discharge Patients|"Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277145|NCT02777021|BG001|Baseline|Inpatient Management Patients|"Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277146|NCT02777021|BG002|Baseline|Total|Total of all reporting groups
11286949|NCT02895945|BG001|Baseline|Minor Surgeries|Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286950|NCT02895945|BG002|Baseline|Total|Total of all reporting groups
11277147|NCT02777021|FG000|Participant Flow|Early Discharge Patients|"Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277148|NCT02777021|FG001|Participant Flow|Inpatient Management Patients|"Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277149|NCT02777021|OG000|Outcome|Early Discharge Patients|Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
11277150|NCT02777021|OG001|Outcome|Inpatient Management Patients|Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
11277151|NCT02777021|EG000|Reported Event|Early Discharge Patients|"Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277152|NCT02777021|EG001|Reported Event|Inpatient Management Patients|"Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.~HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life."
11277153|NCT02777086|BG000|Baseline|StaySafe|"Participants are asked to complete 12 brief, self-administered tablet computer sessions designed to improve decision-making around health risk behaviors. Sessions typically take about 10 minutes each to complete and are scheduled prior to or after probationer group or individual appointments at their probation facility. Sessions are scheduled about once per week.~StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors."
11277154|NCT02777086|BG001|Baseline|Comparison|Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
11277155|NCT02777086|BG002|Baseline|Total|Total of all reporting groups
11277156|NCT02777086|FG000|Participant Flow|StaySafe|"Participants are asked to complete 12 brief, self-administered tablet computer sessions designed to improve decision-making around health risk behaviors. Sessions typically take about 10 minutes each to complete and are scheduled prior to or after probationer group or individual appointments at their probation facility. Sessions are scheduled about once per week.~StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors."
11277157|NCT02777086|FG001|Participant Flow|Comparison|Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
11277158|NCT02777086|OG000|Outcome|StaySafe|"Participants are asked to complete 12 brief, self-administered tablet computer sessions designed to improve decision-making around health risk behaviors. Sessions typically take about 10 minutes each to complete and are scheduled prior to or after probationer group or individual appointments at their probation facility. Sessions are scheduled about once per week.~StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors."
11277159|NCT02777086|OG001|Outcome|Comparison|Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
11277160|NCT02777086|EG000|Reported Event|StaySafe|"Participants are asked to complete 12 brief, self-administered tablet computer sessions designed to improve decision-making around health risk behaviors. Sessions typically take about 10 minutes each to complete and are scheduled prior to or after probationer group or individual appointments at their probation facility. Sessions are scheduled about once per week.~StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors."
11277161|NCT02777086|EG001|Reported Event|Comparison|Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
11277162|NCT02777125|BG000|Baseline|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
11277163|NCT02777125|BG001|Baseline|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
11277164|NCT02777125|BG002|Baseline|Total|Total of all reporting groups
11277165|NCT02777125|FG000|Participant Flow|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
11277166|NCT02777125|FG001|Participant Flow|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
11277167|NCT02777125|OG000|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
11277168|NCT02777125|OG001|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
11277169|NCT02777125|OG001|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject's weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
11286951|NCT02895945|FG000|Participant Flow|Major Surgeries|Male participants with congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target factor VIII (FVIII) level of greater than or equal to (>=) 80 percent (%) approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11277170|NCT02777125|EG000|Reported Event|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.~Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
11277171|NCT02777125|EG001|Reported Event|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject's weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.~Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
11277172|NCT02777242|BG000|Baseline|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
11277173|NCT02777242|FG000|Participant Flow|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
11277174|NCT02777242|OG000|Outcome|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
11277175|NCT02777242|EG000|Reported Event|Testosterone Enanthate Auto-injector|Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
11277176|NCT02777268|BG000|Baseline|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
11277177|NCT02777268|FG000|Participant Flow|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
11277178|NCT02777268|OG000|Outcome|Infacort 10mg|Multi-particulate granules from 10mg Infacort capsule
11277179|NCT02777268|OG001|Outcome|Hydrocortisone|"1 (10 mg) tablet~Hydrocortisone: Tablet"
11277180|NCT02777268|OG000|Outcome|Infacort 10mg|Multi-particulate granules from a 10mg Infacort capsule.
11277181|NCT02777268|OG001|Outcome|Hydrocortisone|10 mg hydrocortisone tablet
11277182|NCT02777268|OG000|Outcome|Infacort 10 mg|Multi-particulate granules from 1 Infacort 10 mg capsule
11277183|NCT02777268|OG001|Outcome|Hydrocortisone|1 (10 mg) hydrocortisone tablet
11277184|NCT02777268|OG000|Outcome|Infacort 0.5mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
11277185|NCT02777268|OG001|Outcome|Infacort 2mg|"Multi-particulate granules from 1 (2mg) capsule~Infacort: Multi-particulate granules"
11277186|NCT02777268|OG002|Outcome|Infacort 5mg|"Multi-particulate granules from 1 (5mg) capsule~Infacort: Multi-particulate granules"
11277187|NCT02777268|OG003|Outcome|Infacort 10mg|"Multi-particulate granules from 1 (10mg) capsule~Infacort: Multi-particulate granules"
11277188|NCT02777268|OG000|Outcome|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
11277189|NCT02777268|OG001|Outcome|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule~Infacort: Multi-particulate granules"
11277190|NCT02777268|OG002|Outcome|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule~Infacort: Multi-particulate granules"
11277191|NCT02777268|OG003|Outcome|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule~Infacort: Multi-particulate granules"
11277192|NCT02777268|OG000|Outcome|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:~Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg~Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
11277193|NCT02777268|EG000|Reported Event|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule~Infacort: Multi-particulate granules"
11277194|NCT02777268|EG001|Reported Event|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule~Infacort: Multi-particulate granules"
11277195|NCT02777268|EG002|Reported Event|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule~Infacort: Multi-particulate granules"
11277196|NCT02777268|EG003|Reported Event|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule~Infacort: Multi-particulate granules"
11277197|NCT02777268|EG004|Reported Event|Hydrocortisone|"1 (10 mg) tablet~Hydrocortisone: Tablet"
11277198|NCT02777333|BG000|Baseline|Simulation Training|Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
11277199|NCT02777333|BG001|Baseline|Non-simulation/Routine Training|Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
11277200|NCT02777333|BG002|Baseline|Total|Total of all reporting groups
11277201|NCT02777333|FG000|Participant Flow|Simulation Training|"Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme~Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators"
11277202|NCT02777333|FG001|Participant Flow|Non-simulation/Routine Training|Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
11277203|NCT02777333|OG000|Outcome|Simulation Training|"Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme~Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators"
11277204|NCT02777333|OG001|Outcome|Non-simulation/Routine Training|Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
11277205|NCT02777333|EG000|Reported Event|Simulation Training|"Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme~Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators"
11277206|NCT02777333|EG001|Reported Event|Non-simulation/Routine Training|Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
11286952|NCT02895945|FG001|Participant Flow|Minor Surgeries|Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286953|NCT02895945|OG000|Outcome|Major Surgeries|Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286954|NCT02895945|OG001|Outcome|Minor Surgeries|Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286955|NCT02895945|EG000|Reported Event|Major Surgeries|Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286956|NCT02895945|EG001|Reported Event|Minor Surgeries|Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
11286957|NCT02896075|BG000|Baseline|All Study Participants|"young healthy people with delayed onset muscle soreness in either the right or left leg will go through the 30 Minute Comedy Video and the 30 Minute Documentary Video.~30 Minute Comedy Video: The intervention is a 30 minute video of a comedy~30 Minute Documentary Video: The intervention is a 30 minute video of an uninteresting documentary"
11286958|NCT02896075|FG000|Participant Flow|All Study Participants Acting Their Own Controls|Each intervention included one day of inducing muscle soreness in one leg through eccentric muscle contractions; a second day of testing muscle soreness and pain tolerance and watching a 30-min video (either a comedy or documentary); and a third day of testing muscle soreness and pain tolerance again to see if the effects of the video viewing persisted the next day (i.e., 24 h after the video viewing).
11286959|NCT02896075|OG000|Outcome|Comedy Video|The intervention is watching a 30 minute video of a comedy
11286960|NCT02896075|OG001|Outcome|Documentary Watching|The intervention is watching a 30 minute video of a documentary
11286961|NCT02896075|OG000|Outcome|Comedy Watching|The intervention is watching a 30 minute video of a comedy
11286962|NCT02896075|OG001|Outcome|Documentary Watching|The intervention is watching a 30 minute video of a documentary.
11286963|NCT02896075|EG000|Reported Event|Leg With and Without Delayed Onset Muscle Soreness|"young healthy people with delayed onset muscle soreness in either the right or left leg will go through the 30 Minute Comedy Video and the 30 Minute Documentary Video.~30 Minute Comedy Video: The intervention is a 30 minute video of a comedy~30 Minute Documentary Video: The intervention is a 30 minute video of an uninteresting documentary"
11286964|NCT02896127|BG000|Baseline|Secukinumab|AIN457 150 mg s.c.
11286965|NCT02896127|BG001|Baseline|Placebo|Placebo s.c.
11286966|NCT02896127|BG002|Baseline|Total|Total of all reporting groups
11286967|NCT02896127|FG000|Participant Flow|Secukinumab|AIN457 150 mg s.c.
11286968|NCT02896127|FG001|Participant Flow|Placebo|Placebo s.c.
11286969|NCT02896127|OG000|Outcome|Secukinumab|AIN457 150 mg s.c.
11286970|NCT02896127|OG001|Outcome|Placebo|Placebo s.c.
11277207|NCT04952701|BG000|Baseline|Overall Study|All subjects wore control lenses for two weeks and then test lenses for two weeks.
11277208|NCT04952701|FG000|Participant Flow|Overall Study|"All subjects wore control lenses for two weeks and then wore Test lenses for two weeks.~Control lenses: Control Multifocal lenses~Test lenses: Test Multifocal lenses"
11277209|NCT04952701|OG000|Outcome|Control Lens|"All subjects wore control lenses for two weeks.~Control lenses: Control Multifocal lenses"
11277210|NCT04952701|OG001|Outcome|Test Lens|"All subjects wore test lenses for two weeks.~Test lenses: Test Multifocal lenses"
11277211|NCT04952701|EG000|Reported Event|Control Lens|"All subjects wore control lenses for two weeks and then wore Test lenses for two weeks.~Control lenses: Control Multifocal lenses"
11277212|NCT04952701|EG001|Reported Event|Test Lens|"After wearing control lenses for two weeks, all subjects wore test lenses for two weeks.~Test lenses: Test Multifocal lenses"
11277213|NCT04350606|BG000|Baseline|PF-06462700|Participants aged 2 years or >2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 mg/kg/day, IV for 4 days. Participants after treatment were followed up for 24 weeks.
11277214|NCT04350606|FG000|Participant Flow|PF-06462700|Participants aged 2 years or greater than (>) 2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 milligram per kilogram per day (mg/kg/day), intravenously (IV) for 4 days. Participants after treatment were followed up for 24 weeks.
11277215|NCT04350606|OG000|Outcome|PF-06462700|Participants aged 2 years or >2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 mg/kg/day, IV for 4 days. Participants after treatment were followed up for 24 weeks.
11277216|NCT04350606|EG000|Reported Event|PF-06462700|Participants aged 2 years or >2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 mg/kg/day, IV for 4 days. Participants after treatment were followed up for 24 weeks.
11277217|NCT04074161|BG000|Baseline|Semaglutide 2.4 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277218|NCT04074161|BG001|Baseline|Liraglutide 3.0 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277219|NCT04074161|BG002|Baseline|Pooled Placebo|Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277220|NCT04074161|BG003|Baseline|Total|Total of all reporting groups
11277221|NCT04074161|FG000|Participant Flow|Semaglutide 2.4 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277222|NCT04074161|FG001|Participant Flow|Liraglutide 3.0 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277223|NCT04074161|FG002|Participant Flow|Pooled Placebo|Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277224|NCT04074161|OG000|Outcome|Semaglutide 2.4 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277225|NCT04074161|OG001|Outcome|Liraglutide 3.0 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277226|NCT04074161|OG002|Outcome|Pooled Placebo|Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11286971|NCT02896127|EG000|Reported Event|Any AIN457 150 mg|This arm includes all patients who received at least 1 dose of study drug.
11286972|NCT02896127|EG001|Reported Event|Placebo|All patients randomized to placebo from baseline up to week 16.
11277227|NCT04074161|EG000|Reported Event|Semaglutide 2.4 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277228|NCT04074161|EG001|Reported Event|Liraglutide 3.0 mg|The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277229|NCT04074161|EG002|Reported Event|Pooled Placebo|Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
11277230|NCT04033432|BG000|Baseline|Treatment|"Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay >= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.~Recombinant EphB4-HSA Fusion Protein: Given IV"
11277231|NCT04033432|FG000|Participant Flow|Treatment|"Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay >= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.~Recombinant EphB4-HSA Fusion Protein: Given IV"
11277232|NCT04033432|OG000|Outcome|Treatment (Recombinant EphB4-HSA Fusion Protein)|"Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay >= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.~Recombinant EphB4-HSA Fusion Protein: Given IV"
11277233|NCT04033432|OG000|Outcome|Treatment|"Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay >= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.~Recombinant EphB4-HSA Fusion Protein: Given IV"
11277234|NCT04033432|EG000|Reported Event|Treatment|"Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay >= 4 weeks, or prohibitive illness/change in patient's condition, or the patient decides to withdraw from the study.~Recombinant EphB4-HSA Fusion Protein: Given IV"
11277235|NCT04030247|BG000|Baseline|Plant Sterol|South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
11277236|NCT04030247|FG000|Participant Flow|Plant Sterol|South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
11277237|NCT04030247|OG000|Outcome|Plant Sterol|South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
11277238|NCT04030247|EG000|Reported Event|Plant Sterol|South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
11286973|NCT02896296|BG000|Baseline|RBP-6000 (100/300 mg Flex)|"On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.~For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator."
11286974|NCT02896296|FG000|Participant Flow|RBP-6000 (100/300 mg Flex)|"On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.~For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator."
11286975|NCT02896296|OG000|Outcome|RBP-6000 (100/300 mg Flex)|"On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.~For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator."
11286976|NCT02896296|EG000|Reported Event|RBP-6000 (100/300 mg Flex)|"On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.~For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator."
11286977|NCT02896361|BG000|Baseline|All Subjects|Baseline characteristics for all subjects
11277239|NCT03893565|BG000|Baseline|Placebo IV|Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277240|NCT03893565|BG001|Baseline|GSK2831781 450 mg IV|Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277241|NCT03893565|BG002|Baseline|GSK2831781 300 mg IV|Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277242|NCT03893565|BG003|Baseline|GSK2831781 150 mg IV|Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277243|NCT03893565|BG004|Baseline|GSK2831781 45 mg IV|Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277244|NCT03893565|BG005|Baseline|Total|Total of all reporting groups
11277245|NCT03893565|FG000|Participant Flow|Placebo IV|Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277246|NCT03893565|FG001|Participant Flow|GSK2831781 450 mg IV|Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277247|NCT03893565|FG002|Participant Flow|GSK2831781 300 mg IV|Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277248|NCT03893565|FG003|Participant Flow|GSK2831781 150 mg IV|Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277249|NCT03893565|FG004|Participant Flow|GSK2831781 45 mg IV|Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277250|NCT03893565|FG005|Participant Flow|Placebo SC|Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277251|NCT03893565|FG006|Participant Flow|GSK2831781 300 mg SC|Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277252|NCT03893565|FG007|Participant Flow|Open-label GSK2831781 450 mg IV|Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
11277253|NCT03893565|FG008|Participant Flow|Open-label GSK2831781 300 mg SC|Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
11277254|NCT03893565|OG000|Outcome|Placebo IV|Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277255|NCT03893565|OG001|Outcome|GSK2831781 450 mg IV|Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277256|NCT03893565|OG002|Outcome|GSK2831781 300 mg IV|Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277257|NCT03893565|OG003|Outcome|GSK2831781 150 mg IV|Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277258|NCT03893565|OG004|Outcome|GSK2831781 45 mg IV|Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277259|NCT03893565|OG000|Outcome|Placebo SC|Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277260|NCT03893565|OG001|Outcome|GSK2831781 300 mg SC|Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277261|NCT03893565|OG000|Outcome|GSK2831781 300 mg SC|Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277262|NCT03893565|EG000|Reported Event|Placebo IV|Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277263|NCT03893565|EG001|Reported Event|GSK2831781 450 mg IV|Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277264|NCT03893565|EG002|Reported Event|GSK2831781 300 mg IV|Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277265|NCT03893565|EG003|Reported Event|GSK2831781 150 mg IV|Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277266|NCT03893565|EG004|Reported Event|GSK2831781 45 mg IV|Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
11277267|NCT03893565|EG005|Reported Event|Placebo SC|Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
10970517|NCT00910858|OG000|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970518|NCT00910858|OG001|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11277268|NCT03893565|EG006|Reported Event|GSK2831781 300 mg SC|Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
11277269|NCT03893565|EG007|Reported Event|Open-label GSK2831781 450 mg IV|Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
11277270|NCT03893565|EG008|Reported Event|Open-label GSK2831781 300 mg SC|Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
11277271|NCT03701516|BG000|Baseline|Dispensed Subject|All subjects dispensed a study lens.
11277272|NCT03701516|FG000|Participant Flow|Test/Control|Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period.
11277273|NCT03701516|FG001|Participant Flow|Control/Test|Subjects randomized to receive the Control lens during the first period and then receive the Test lens during the second period.
11277274|NCT03701516|OG000|Outcome|Test|Subjects that wore the Test lens in either the first or second period of the study.
11277275|NCT03701516|OG001|Outcome|Control|Subjects that wore the Control lens in either the first or second period of the study.
11277276|NCT03701516|EG000|Reported Event|Test|Subjects that wore the Test lens in either the first or second period of the study.
11277277|NCT03701516|EG001|Reported Event|Control|Subjects that wore the Control lens in either the first or second period of the study.
11277278|NCT03650556|BG000|Baseline|Ablation|All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
11277279|NCT03650556|FG000|Participant Flow|Enrolled|A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
11277280|NCT03650556|OG000|Outcome|Enrolled|A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
11277281|NCT03650556|OG000|Outcome|Ablation|"Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.~TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™: Ablation procedure for Persistent AF"
11277282|NCT03650556|EG000|Reported Event|Enrolled|A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
11277283|NCT03639311|BG000|Baseline|CAB LA + RPV LA Q2M|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
11277284|NCT03639311|BG001|Baseline|DTG + RPV|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
11277285|NCT03639311|BG002|Baseline|Total|Total of all reporting groups
11286978|NCT02896361|FG000|Participant Flow|Stimulation Order 1|"Stimulations delivered in following order:~Standard burst for 2 weeks~Burst Microdosing 1 for 2 weeks~Burst Microdosing 2 for 2 weeks~Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones"
11277286|NCT03639311|FG000|Participant Flow|CAB LA + RPV LA Q2M|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
11277287|NCT03639311|FG001|Participant Flow|DTG + RPV|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
11277288|NCT03639311|OG000|Outcome|CAB LA + RPV LA Q2M|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
11277289|NCT03639311|OG001|Outcome|DTG + RPV|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
11277290|NCT03639311|OG000|Outcome|DTG + RPV|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
11277291|NCT03639311|OG000|Outcome|CAB LA|Participants in this arm received their first dose CAB LA (600 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (CAB LA 600 mg) occurring Q2M thereafter.
11277292|NCT03639311|OG000|Outcome|RPV LA|Participants in this arm received their first dose RPV LA (900 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (RPV LA 900 mg) occurring Q2M thereafter.
11277293|NCT03639311|EG000|Reported Event|CAB LA + RPV LA Q2M|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
11277294|NCT03639311|EG001|Reported Event|DTG + RPV|Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
11277295|NCT03628716|BG000|Baseline|CV301 + Atezolizumab (Cohort 1)|Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy
11277296|NCT03628716|BG001|Baseline|CV301 + Atezolizumab (Cohort 2)|Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
11277297|NCT03628716|BG002|Baseline|Total|Total of all reporting groups
11277298|NCT03628716|FG000|Participant Flow|CV301 + Atezolizumab (Cohort 1)|Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy
11277299|NCT03628716|FG001|Participant Flow|CV301 + Atezolizumab (Cohort 2)|Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
11277300|NCT03628716|OG000|Outcome|CV301 + Atezolizumab (Cohort 1)|Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy
11277301|NCT03628716|OG001|Outcome|CV301 + Atezolizumab (Cohort 2)|Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
11277302|NCT03628716|OG000|Outcome|CV301 + Atezolizumab (Cohort 1)|Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy
11277303|NCT03628716|OG001|Outcome|CV301 + Atezolizumab (Cohort 2)|Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
11277304|NCT03628716|EG000|Reported Event|CV301 + Atezolizumab (Cohort 1)|Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy
11277305|NCT03628716|EG001|Reported Event|CV301 + Atezolizumab (Cohort 2)|Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
11277306|NCT03377699|BG000|Baseline|IDeg|Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277307|NCT03377699|BG001|Baseline|IDet|Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277308|NCT03377699|BG002|Baseline|Total|Total of all reporting groups
11277309|NCT03377699|FG000|Participant Flow|IDeg|Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277310|NCT03377699|FG001|Participant Flow|IDet|Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277311|NCT03377699|OG000|Outcome|IDeg|Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277312|NCT03377699|OG001|Outcome|IDet|Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11286979|NCT02896361|FG001|Participant Flow|Stimulation Order 2|"Stimulations delivered in following order:~Burst Microdosing 1 for 2 weeks~Burst Microdosing 2 for 2 weeks~Standard burst for 2 weeks~Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones"
11277313|NCT03377699|EG000|Reported Event|IDeg|Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277314|NCT03377699|EG001|Reported Event|IDet|Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277315|NCT03377699|EG002|Reported Event|IDegInf|Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11277316|NCT03377699|EG003|Reported Event|IDetInf|Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
11286980|NCT02896361|FG002|Participant Flow|Stimulation Order 3|"Stimulations delivered in following order:~Burst Microdosing 2 for 2 weeks~Standard burst for 2 weeks~Burst Microdosing 1 for 2 weeks~Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones"
11286981|NCT02896361|OG000|Outcome|Microdosing A(5:5)|Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
11286982|NCT02896361|OG001|Outcome|Microdosing B: 5:10|Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
11286983|NCT02896361|OG002|Outcome|Continuous|Continuously delivered burst SCS
11286984|NCT02896361|OG000|Outcome|Stimulation Order 1|"Stimulations delivered in following order:~Standard burst for 2 weeks~Burst Microdosing 1 for 2 weeks~Burst Microdosing 2 for 2 weeks"
11286985|NCT02896361|OG001|Outcome|Stimulation Order 2|"Stimulations delivered in following order:~Burst Microdosing 1 for 2 weeks~Burst Microdosing 2 for 2 weeks~Standard burst for 2 weeks"
11286986|NCT02896361|OG002|Outcome|Stimulation Order 3|"timulations delivered in following order:~Burst Microdosing 2 for 2 weeks~Standard burst for 2 weeks~Burst Microdosing 1 for 2 weeks"
11286987|NCT02896361|OG000|Outcome|All Subjects|Baseline characteristics for all subjects
11286988|NCT02896361|EG000|Reported Event|Standard Burst|"reporting per intervention adverse events experienced while standard continuous burst was delivered"
11286989|NCT02896361|EG001|Reported Event|Burst Microdosing 1|"reporting per intervention adverse events experienced while burst microdosing 1 was delivered"
11286990|NCT02896361|EG002|Reported Event|Burst Microdosing 2|"reporting per intervention adverse events experienced while burst microdosing 2 was delivered"
11286991|NCT02896400|BG000|Baseline|NRT+QL+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11286992|NCT02896400|BG001|Baseline|BNI+QL+Text|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11277317|NCT03275350|BG000|Baseline|Extended-release Naltrexone (XR-NTX)|"Extended-release naltrexone~Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone"
11277318|NCT03275350|BG001|Baseline|Treatment as Usual (TAU)|"Treatment as usual~Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic"
11277319|NCT03275350|BG002|Baseline|Total|Total of all reporting groups
11277320|NCT03275350|FG000|Participant Flow|Extended-release Naltrexone (XR-NTX)|"Extended-release naltrexone~Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone"
11277321|NCT03275350|FG001|Participant Flow|Treatment as Usual (TAU)|"Treatment as usual~Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic"
11277322|NCT03275350|OG000|Outcome|Extended-release Naltrexone (XR-NTX)|"Extended-release naltrexone~Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone"
11277323|NCT03275350|OG001|Outcome|Treatment as Usual (TAU)|"Treatment as usual~Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic"
11277324|NCT03275350|OG000|Outcome|Extended-release Naltrexone (XR-NTX)|"Extended-release naltrexone~Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone."
11277325|NCT03275350|EG000|Reported Event|Extended-release Naltrexone (XR-NTX)|"Extended-release naltrexone~Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone"
11277326|NCT03275350|EG001|Reported Event|Treatment as Usual (TAU)|"Treatment as usual~Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic"
11277327|NCT03272347|BG000|Baseline|Islatravir 0.25 mg|Participants were treated QD with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277328|NCT03272347|BG001|Baseline|Islatravir 0.75 mg|Participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277329|NCT03272347|BG002|Baseline|Islatravir 2.25 mg|Participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277330|NCT03272347|BG003|Baseline|Doravirine, Tenofovir, Lamivudine|Participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and doravirine, tenofovir, lamivudine consisting of 100 mg DOR + 300 mg 3TC + 300 mg tenofovir disoproxil fumarate (TDF) for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments were discontinued and participants received only doravirine, tenofovir, lamivudine QD open label up to Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277331|NCT03272347|BG004|Baseline|Total|Total of all reporting groups
11277332|NCT03272347|FG000|Participant Flow|Islatravir 0.25 mg|Participants were treated once daily (QD) with 0.25 mg islatravir, 100 mg doravirine (DOR), 300 mg lamivudine (3TC), and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no Protocol-defined Virologic Failure (PDVF), between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277333|NCT03272347|FG001|Participant Flow|Islatravir 0.75 mg|Participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277334|NCT03272347|FG002|Participant Flow|Islatravir 2.25 mg|Participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277335|NCT03272347|FG003|Participant Flow|Doravirine, Tenofovir, Lamivudine|Participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and doravirine, tenofovir, lamivudine consisting of 100 mg DOR + 300 mg 3TC + 300 mg tenofovir disoproxil fumarate (TDF) for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments were discontinued and participants received only doravirine, tenofovir, lamivudine QD open label up to Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277336|NCT03272347|OG000|Outcome|Islatravir 0.25 mg|Participants were treated QD with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277337|NCT03272347|OG001|Outcome|Islatravir 0.75 mg|Participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277338|NCT03272347|OG002|Outcome|Islatravir 2.25 mg|Participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277339|NCT03272347|OG003|Outcome|Doravirine, Tenofovir, Lamivudine|Participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and doravirine, tenofovir, lamivudine consisting of 100 mg DOR + 300 mg 3TC + 300 mg tenofovir disoproxil fumarate (TDF) for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments were discontinued and participants received only doravirine, tenofovir, lamivudine QD open label up to Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277340|NCT03272347|EG000|Reported Event|Islatravir 0.25mg|Participants were treated QD with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277341|NCT03272347|EG001|Reported Event|Islatravir 0.75mg|Participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277342|NCT03272347|EG002|Reported Event|Islatravir 2.25mg|Participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine, tenofovir, lamivudine for a minimum of 24 weeks. For participants with HIV-1 RNA <50 copies/mL and no PDVF, between week 24 through week 52, 3TC and placebo to doravirine, tenofovir, lamivudine was discontinued. After a minimum 48 weeks of treatment, participants were switched to open label dose of 0.75 mg islatravir and DOR 100 mg QD and continued treatment until Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277343|NCT03272347|EG003|Reported Event|Doravirine, Tenofivir, Lamivudine|Participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and doravirine, tenofovir, lamivudine consisting of 100 mg DOR + 300 mg 3TC + 300 mg tenofovir disoproxil fumarate (TDF) for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments were discontinued and participants received only doravirine, tenofovir, lamivudine QD open label up to Week 144. At Week 144 participants received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
11277344|NCT03138369|BG000|Baseline|Vestibular Nerve Stimulation|"Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week.~Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used."
11277345|NCT03138369|BG001|Baseline|Sham Vestibular Nerve Stimulation|"Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week.~Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve."
11277346|NCT03138369|BG002|Baseline|Total|Total of all reporting groups
11277347|NCT03138369|FG000|Participant Flow|Vestibular Nerve Stimulation|"Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week.~Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used."
11092316|NCT01539135|FG000|Participant Flow|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277348|NCT03138369|FG001|Participant Flow|Sham Vestibular Nerve Stimulation|"Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week.~Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve."
11277349|NCT03138369|OG000|Outcome|Vestibular Nerve Stimulation|"Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week.~Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used."
11277350|NCT03138369|OG001|Outcome|Sham Vestibular Nerve Stimulation|"Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week.~Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve."
11277351|NCT03138369|OG001|Outcome|Sham Vestibular Nerve Stimulation|"Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week.~Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharge when not being used. However it discharges into an internal resistor and does not stimulate the vestibular nerve."
11277352|NCT03138369|EG000|Reported Event|Vestibular Nerve Stimulation|"Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week.~Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used."
11277353|NCT03138369|EG001|Reported Event|Sham Vestibular Nerve Stimulation|"Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week.~Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve."
11277367|NCT02758184|BG000|Baseline|Rotational Thrombo-elastometry (ROTEM) Group|"Patients who are randomized to receive ROTEM~ROTEM-based coagulation monitoring~Spine surgery"
11277368|NCT02758184|BG001|Baseline|Control Group|"Patients who are randomized not to receive ROTEM~Spine surgery"
11277369|NCT02758184|BG002|Baseline|Total|Total of all reporting groups
11277370|NCT02758184|FG000|Participant Flow|Rotational Thrombo-elastometry (ROTEM) Group|"Patients who are randomized to receive ROTEM~ROTEM-based coagulation monitoring~Spine surgery"
11277371|NCT02758184|FG001|Participant Flow|Control Group|"Patients who are randomized not to receive ROTEM~Spine surgery"
11277372|NCT02758184|OG000|Outcome|Rotational Thrombo-elastometry (ROTEM) Group|"Patients who are randomized to receive ROTEM~ROTEM-based coagulation monitoring~Spine surgery"
11092317|NCT01539135|FG001|Participant Flow|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277373|NCT02758184|OG001|Outcome|Control Group|"Patients who are randomized not to receive ROTEM~Spine surgery"
11092318|NCT01539135|OG000|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277374|NCT02758184|EG000|Reported Event|Rotational Thrombo-elastometry (ROTEM) Group|"Patients who are randomized to receive ROTEM~ROTEM-based coagulation monitoring~Spine surgery"
11277375|NCT02758184|EG001|Reported Event|Control Group|"Patients who are randomized not to receive ROTEM~Spine surgery"
11277376|NCT02677870|BG000|Baseline|Overall Study|"Enrolled patients with PKU received diet treatment only for 4 weeks. Then were randomized into high dose saproterin dihydrochloride (40 mg/kg/day) or low dose saproterin dihydrochloride(20 mg/kg/day).~They completed 4 weeks of treatment at either dose and then underwent a 2 week washout period without any medication.~After the washout period, they were crossed over to receive the opposite dose for 4 weeks."
11277377|NCT02677870|FG000|Participant Flow|Diet tx, Standard Dose Saproterin, Wash, High Dose Saproterin|"Enrolled patients with PKU received diet treatment only for 4 weeks. During this portion, no medication was administered and they followed their baseline low protein diet.~They were then were randomized into standard dose Saproterin dihydrochloride(20 mg/kg/day). They completed 4 weeks of treatment with dosing above being administered once per day.~There was then a 2 week washout period with no intervention.~They were then treated with high dose Saproterin dihydrochloride (40 mg/kg/day). They completed 4 weeks of treatment with dosing above being administered once per day."
11277378|NCT02677870|FG001|Participant Flow|Diet, High Dose Saproterin, Wash, Standard Dose Saproterin|"Enrolled patients with PKU received diet treatment only for 4 weeks. During this portion, no medication was administered and they followed their baseline low protein diet.~They were then were randomized into high dose Saproterin dihydrochloride (40 mg/kg/day). They completed 4 weeks of treatment with dosing above being administered once per day.~There was then a 2 week washout period with no intervention.~They were then treated with standard dose Saproterin dihydrochloride(20 mg/kg/day). They completed 4 weeks of treatment with dosing above being administered once per day."
11277379|NCT02677870|OG000|Outcome|Diet Treatment|Enrolled patients with PKU received diet treatment only for 4 weeks. During this portion, no medication was administered and they followed their baseline low protein diet.
11277380|NCT02677870|OG001|Outcome|Standard Dose Saproterin Dihydrochloride|Participants who received Saproterin dihydrochloride at a dose of 20 mg/kg once daily (for 4 weeks) in either the first intervention or second intervention of the study.
11277381|NCT02677870|OG002|Outcome|High Dose Saproterin Dihydrochloride|Participants who received Saproterin dihydrochloride at a dose of 40 mg/kg once daily (for 4 weeks) in either the first intervention or second intervention of the study.
11277382|NCT02677870|EG000|Reported Event|Diet Treatment|"In part 1 of the study, patients will not receive any medication. Each patient will DIET treatment alone. They will maintain a stable, Phe restricted diet (including formula) that is consistent with their diet at the time of enrollment. This will be monitored by food diaries kept for 3 days of each week. Based on these diaries, average weekly Phe intake and Phe tolerance will be calculated and recorded.~Diet treatment: Patients will maintain a stable, Phe restricted diet (including formula) that is consistent with their diet at the time of enrollment. This will be monitored by food diaries kept for 3 days of each week."
11286993|NCT02896400|BG002|Baseline|BNI+NRT+QL+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11277383|NCT02677870|EG001|Reported Event|Standard Dose Saproterin Dihydrochloride|"Study numbers will be randomized into standard-dose saproterin dihydrochloride (Kuvan) or high-dose saproterin dihydrochloride (Kuvan)  groups (treatment group A or treatment group B). Both groups will receive a trial of both standard and high dose saproterin dihydrochloride before the end of the study. Standard-dose saproterin dihydrochloride will be 20mg/kg (rounded up to the nearest 100mg) provided in the form of 100mg tablets. Dosing of the tablets will be unidentifiable to patients. Medication will be given orally once daily.~saproterin dihydrochloride: The drug will be given as described in the arm/group descriptions.~Diet treatment: Patients will maintain a stable, Phe restricted diet (including formula) that is consistent with their diet at the time of enrollment. This will be monitored by food diaries kept for 3 days of each week."
11277384|NCT02677870|EG002|Reported Event|High Dose Saproterin Dihydrochloride|"Study numbers will be randomized into standard-dose saproterin or high-dose saproterin groups (treatment group A or treatment group B). Both groups will receive a trial of both standard and high dose saproterin dihydrochloride before the end of the study. Goal high-dose saproterin dihydrochloride dosing will be 40mg/kg (rounded up to the nearest 500mg), provided in the form of pre-packaged 500mg packets of powder. Labeled dosing on these packets will be covered by the investigational drug pharmacy and unidentifiable to patients. Dosing of the tablets will be unidentifiable to patients. Medication will be given orally once daily.~saproterin dihydrochloride: The drug will be given as described in the arm/group descriptions.~Diet treatment: Patients will maintain a stable, Phe restricted diet (including formula) that is consistent with their diet at the time of enrollment. This will be monitored by food diaries kept for 3 days of each week."
11277385|NCT02674750|BG000|Baseline|Group A|MYC translocation+ and/or MYC gene copy number gain by FISH
11277386|NCT02674750|BG001|Baseline|Group B|MYC expression in > 40% of tumor cells by IHC
11277387|NCT02674750|BG002|Baseline|Group C|MYC translocation- by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH
11277388|NCT02674750|BG003|Baseline|Total|Total of all reporting groups
11277389|NCT02674750|FG000|Participant Flow|Group A|MYC translocation+ and/or MYC gene copy number gain by FISH
11277390|NCT02674750|FG001|Participant Flow|Group B|MYC expression in > 40% of tumor cells by IHC
11277391|NCT02674750|FG002|Participant Flow|Group C|MYC translocation- by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH
11277392|NCT02674750|OG000|Outcome|CUDC-907|"RR-DLBCL, including with MYC alterations detected by FISH or by >=40% MYC by IHC~CUDC-907"
11277393|NCT02674750|OG000|Outcome|Group A|MYC translocation+ and/or MYC gene copy number gain by FISH
11277394|NCT02674750|OG001|Outcome|Group B|MYC expression in > 40% of tumor cells by IHC
11277395|NCT02674750|OG002|Outcome|Group C|MYC translocation- by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH
11277396|NCT02674750|EG000|Reported Event|CUDC-907|"RR-DLBCL, including with MYC alterations detected by FISH or by >=40% MYC by IHC~CUDC-907"
11277397|NCT02440854|BG000|Baseline|Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib|Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.
11277398|NCT02440854|FG000|Participant Flow|Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib|Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.
11277399|NCT02440854|OG000|Outcome|Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib|Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.
11277400|NCT02440854|EG000|Reported Event|Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib|Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.
11277401|NCT02278185|BG000|Baseline|Arm I (Enzalutamide)|"Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO"
11277402|NCT02278185|BG001|Baseline|Arm II (ADT)|"Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.~leuprolide acetate: Given SC or IM~goserelin acetate: Given SC or IM~histrelin acetate: Given SC or IM~triptorelin: Given SC or IM~degarelix: Given SC or IM"
11277403|NCT02278185|BG002|Baseline|Total|Total of all reporting groups
11277404|NCT02278185|FG000|Participant Flow|Arm I (Enzalutamide)|"Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO"
11277405|NCT02278185|FG001|Participant Flow|Arm II (ADT)|"Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.~leuprolide acetate: Given SC or IM~goserelin acetate: Given SC or IM~histrelin acetate: Given SC or IM~triptorelin: Given SC or IM~degarelix: Given SC or IM"
11277406|NCT02278185|OG000|Outcome|Arm I (Enzalutamide)|"Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO"
11277407|NCT02278185|OG001|Outcome|Arm II (ADT)|"Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.~leuprolide acetate: Given SC or IM~goserelin acetate: Given SC or IM~histrelin acetate: Given SC or IM~triptorelin: Given SC or IM~degarelix: Given SC or IM"
11277408|NCT02278185|OG000|Outcome|Enzalutamide|Patients exposed to enzalutamide
11277409|NCT02278185|OG001|Outcome|Androgen Deprivation Therapy|Patients exposed to androgen deprivation therapy
11277410|NCT02278185|EG000|Reported Event|Arm I (Enzalutamide)|"Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.~Enzalutamide: Given PO"
11277411|NCT02278185|EG001|Reported Event|Arm II (ADT)|"Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.~leuprolide acetate: Given SC or IM~goserelin acetate: Given SC or IM~histrelin acetate: Given SC or IM~triptorelin: Given SC or IM~degarelix: Given SC or IM"
11286994|NCT02896400|BG003|Baseline|NRT+QL|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11286995|NCT02896400|BG004|Baseline|BNI+QL|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11286996|NCT02896400|BG005|Baseline|NRT Only|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11286997|NCT02896400|BG006|Baseline|BNI+Text|"Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11286998|NCT02896400|BG007|Baseline|BNI+NRT+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11286999|NCT02896400|BG008|Baseline|NRT+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287000|NCT02896400|BG009|Baseline|BNI+NRT|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11287001|NCT02896400|BG010|Baseline|Control|Control arm, no intervention
11287002|NCT02896400|BG011|Baseline|BNI+NRT+QL|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287003|NCT02896400|BG012|Baseline|Text Only|"Registration in SmokefreeText (Text)~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287004|NCT02896400|BG013|Baseline|QL+Text|"Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287005|NCT02896400|BG014|Baseline|BNI Only|"Brief Negotiated Interview (BNI)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior"
11287006|NCT02896400|BG015|Baseline|QL Only|"Referral to CT Smokers Quitline (QL)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287007|NCT02896400|BG016|Baseline|Total|Total of all reporting groups
11287008|NCT02896400|FG000|Participant Flow|NRT+QL+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11277412|NCT02154529|BG000|Baseline|Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277413|NCT02154529|BG001|Baseline|Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277414|NCT02154529|BG002|Baseline|Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277415|NCT02154529|BG003|Baseline|Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277416|NCT02154529|BG004|Baseline|Total|Total of all reporting groups
11277417|NCT02154529|FG000|Participant Flow|Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277418|NCT02154529|FG001|Participant Flow|Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277419|NCT02154529|FG002|Participant Flow|Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277420|NCT02154529|FG003|Participant Flow|Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277421|NCT02154529|OG000|Outcome|Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277422|NCT02154529|OG001|Outcome|Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277423|NCT02154529|OG002|Outcome|Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
11277424|NCT02154529|OG003|Outcome|Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277425|NCT02154529|OG004|Outcome|All Patients|Combination of subjects in Cohorts 1, 2, 3, and 4
11277426|NCT02154529|EG000|Reported Event|Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
11277427|NCT02154529|EG001|Reported Event|Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
11277428|NCT02154529|EG002|Reported Event|Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277429|NCT02154529|EG003|Reported Event|Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV|Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
11277430|NCT02154529|EG004|Reported Event|All Patients|Combination of subjects in Cohorts 1, 2, 3, and 4
11277431|NCT00788125|BG000|Baseline|Period 1: 35 mg/m^2 Dasatinib BID PO|"35mg/m^2/dose BID PO Dasatinib x 17 days~Ifosfamide, Carboplatin, Etoposide~microarray analysis~western blotting~immunohistochemistry staining method~laboratory biomarker analysis~therapeutic conventional surgery~radiation therapy"
11277432|NCT00788125|FG000|Participant Flow|Period 1: 35 mg/m^2 Dasatinib BID PO|"35 mg/m^2/dose BID PO Dasatinib x 17 days~Ifosfamide, Carboplatin, Etoposide~microarray analysis~western blotting~immunohistochemistry staining method~laboratory biomarker analysis~therapeutic conventional surgery~radiation therapy"
11277433|NCT00788125|OG000|Outcome|Period 1: 35 mg/m^2/Dose BID PO Dasatinib x 17 Days|"35 mg/m^2/dose BID PO Dasatinib x 17 days~Ifosfamide, Carboplatin, Etoposide~therapeutic conventional surgery~radiation therapy"
11277434|NCT00788125|EG000|Reported Event|Period 1: 35 mg/m^2 Dasatinib BID PO|"35mg/m^2/dose BID PO Dasatinib x 17 days~Iphosfamide, Carboplatin, Etoposide~microarray analysis~western blotting~immunohistochemistry staining method~laboratory biomarker analysis~therapeutic conventional surgery~radiation therapy"
11277435|NCT02777554|BG000|Baseline|Part 1|Participants in Part 1 received apremilast 30 mg IR tablet BID for 7 days and apremilast 75 mg XL formulation QD for 7 days in each treatment period depending on sequence assignment.
11277436|NCT02777554|BG001|Baseline|Part 2|"Participants in Part 2 received a single dose of the following treatments in 4 treatment periods according to sequence assignment:~Apremilast 30 mg IR tablet in the morning and evening under fasted conditions;~Apremilast 75 mg XL formulation after a high-fat meal;~Apremilast 75 mg XL formulation under fasted conditions;~Apremilast 75 mg XL formulation after a standard meal."
11277437|NCT02777554|BG002|Baseline|Total|Total of all reporting groups
11277438|NCT02777554|FG000|Participant Flow|Part 1: Apremilast 30 mg IR BID / Apremilast 75 mg XL QD|Participants received apremilast 30 mg immediate release (IR) tablet twice a day (BID) for 7 days in treatment period 1 then apremilast 75 mg extended release (XL) formulation once a day (QD) for 7 days in treatment period 2. There was a 5.5 to 9.5-day washout period between each treatment period.
11277439|NCT02777554|FG001|Participant Flow|Part 1: Apremilast 75 mg XL QD / Apremilast 30 mg IR BID|Participants received apremilast 75 mg XL formulation once a day for 7 days in treatment period 1 then apremilast 30 mg IR tablet twice a day for 7 days in treatment period 2. There was a 6 to 10-day washout period between each treatment period.
11287009|NCT02896400|FG001|Participant Flow|BNI+QL+Text|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11277440|NCT02777554|FG002|Participant Flow|Part 2: Sequence 1|"Participants received a single dose of apremilast in each of 4 treatment periods according to the following:~Treatment period 1: Apremilast 30 mg IR tablet in the morning and evening under fasted conditions; Treatment period 2: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 3: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 4: Apremilast 75 mg XL formulation after a standard meal. There was a washout period of approximately 6 to 10 days between each treatment period."
11277441|NCT02777554|FG003|Participant Flow|Part 2: Sequence 2|"Participants received a single dose of apremilast in each of 4 treatment periods according to the following:~Treatment period 1: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 2: Apremilast 30 mg IR tablet in the morning and evening under fasted conditions; Treatment period 3: Apremilast 75 mg XL formulation after a standard meal; Treatment period 4: Apremilast 75 mg XL formulation after a high-fat meal. There was a washout period of approximately 6 to 10 days between each treatment period."
11277442|NCT02777554|FG004|Participant Flow|Part 2: Sequence 3|"Participants received a single dose of apremilast in each of 4 treatment periods according to the following:~Treatment period 1: Apremilast 75 mg XL formulation after a standard meal; Treatment period 2: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 3: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 4: Apremilast 30 mg IR tablet in the morning and evening under fasted conditions.~There was a washout period of approximately 6 to 10 days between each treatment period."
11277443|NCT02777554|FG005|Participant Flow|Part 2: Sequence 4|"Participants received a single dose of apremilast in each of 4 treatment periods according to the following:~Treatment period 1: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 2: Apremilast 75 mg XL formulation after a standard meal; Treatment period 3: Apremilast 30 mg IR tablet in the morning and evening under fasted conditions; Treatment period 4: Apremilast 75 mg XL formulation under fasted conditions. There was a washout period of approximately 6 to 10 days between each treatment period."
11277444|NCT02777554|OG000|Outcome|Part 1: Apremilast 30 mg IR BID|Participants received apremilast 30 mg IR tablet BID for 7 days.
11277445|NCT02777554|OG001|Outcome|Part 1: Apremilast 75 mg XL QD|Participants received apremilast 75 mg XL formulation QD for 7 days.
11277446|NCT02777554|OG000|Outcome|Part 2: Apremilast 30 mg IR BID (Fasted)|Participants received one apremilast 30 mg IR tablet in the morning and one in the evening under fasted conditions.
11277447|NCT02777554|OG001|Outcome|Part 2: Apremilast 75 mg XL (Fasted)|Participants received a single dose of apremilast 75 mg XL formulation under fasted conditions.
11277448|NCT02777554|OG002|Outcome|Part 2: Apremilast 75 mg XL (Standard Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a standard meal.
11277449|NCT02777554|OG003|Outcome|Part 2: Apremilast 75 mg XL (High Fat Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a high-fat meal.
11092319|NCT01539135|OG001|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277450|NCT02777554|OG002|Outcome|Part 2: Apremilast 30 mg IR BID (Fasted)|Participants received one apremilast 30 mg IR tablet in the morning and one in the evening under fasted conditions.
11277451|NCT02777554|OG003|Outcome|Part 2: Apremilast 75 mg XL (Fasted)|Participants received a single dose of apremilast 75 mg XL formulation under fasted conditions.
11277452|NCT02777554|OG004|Outcome|Part 2: Apremilast 75 mg XL (Standard Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a standard meal.
11277453|NCT02777554|OG005|Outcome|Part 2: Apremilast 75 mg XL (High Fat Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a high-fat meal.
11277454|NCT02777554|EG000|Reported Event|Part 1: Apremilast 30 mg IR BID|Participants received apremilast 30 mg IR tablet BID for 7 days.
11277455|NCT02777554|EG001|Reported Event|Part 1: Apremilast 75 mg XL QD|Participants received apremilast 75 mg XL formulation QD for 7 days.
11277456|NCT02777554|EG002|Reported Event|Part 1 Total|Participants in Part 1 received apremilast 30 mg IR tablet BID for 7 days and apremilast 75 mg XL formulation QD for 7 days in each treatment period depending on sequence assignment.
11277457|NCT02777554|EG003|Reported Event|Part 2: Apremilast 30 mg IR (Fasted)|Participants received one apremilast 30 mg IR tablet in the morning and one in the evening under fasted conditions
11092320|NCT01539135|EG000|Reported Event|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277458|NCT02777554|EG004|Reported Event|Part 2: Apremilast 75 mg XL (Fasted)|Participants received a single dose of apremilast 75 mg XL formulation under fasted conditions.
11277459|NCT02777554|EG005|Reported Event|Part 2: Apremilast 75 mg XL (Standard Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a standard meal.
11277460|NCT02777554|EG006|Reported Event|Part 2: Apremilast 75 mg XL (High Fat Meal)|Participants received a single dose of apremilast 75 mg XL formulation after a high-fat meal.
11277461|NCT02777554|EG007|Reported Event|Part 2 Total|"Participants in Part 2 received a single dose of the following treatments in 4 treatment periods according to sequence assignment:~Apremilast 30 mg IR tablet in the morning and evening under fasted conditions;~Apremilast 75 mg XL formulation under fasted conditions;~Apremilast 75 mg XL formulation after a standard meal;~Apremilast 75 mg XL formulation after a high-fat meal."
11277462|NCT02777749|BG000|Baseline|Adductor Canal Block|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~Adductor Canal Block (ACB)~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277463|NCT02777749|BG001|Baseline|Periarticular SB|"20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277464|NCT02777749|BG002|Baseline|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277465|NCT02777749|BG003|Baseline|Total|Total of all reporting groups
11277466|NCT02777749|FG000|Participant Flow|Adductor Canal Block|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~Adductor Canal Block (ACB)~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277467|NCT02777749|FG001|Participant Flow|Periarticular SB|"50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277468|NCT02777749|FG002|Participant Flow|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277469|NCT02777749|OG000|Outcome|Adductor Canal Block|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~Adductor Canal Block (ACB)~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277470|NCT02777749|OG001|Outcome|Periarticular SB|"50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277471|NCT02777749|OG002|Outcome|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277472|NCT02777749|OG001|Outcome|Periarticular SB|"50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection"
11277473|NCT02777749|OG002|Outcome|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277474|NCT02777749|OG000|Outcome|Adductor Canal Block|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~Adductor Canal Block (ACB)~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277475|NCT02777749|OG002|Outcome|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or50 cc's short-acting bupivacaine (SB), intramuscular injection"
11277476|NCT02777749|EG000|Reported Event|Adductor Canal Block|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~Adductor Canal Block (ACB)~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection"
11277477|NCT02777749|EG001|Reported Event|Periarticular SB|"50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection"
11277478|NCT02777749|EG002|Reported Event|ACB + SB|"15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.~50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.~Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection"
11277479|NCT02777827|BG000|Baseline|Overall Study Population|
11277480|NCT02777827|FG000|Participant Flow|Sequence 1|Abediterol dry powder inhaler (DPI) 0.156 μg, followed by Abediterol pressurised metered-dose inhaler (pMDI) 0.05 μg; Placebo; Abediterol pMDI 0.156 μg; Abediterol DPI 2.5 μg; Abediterol pMDI 2.5 μg
11277481|NCT02777827|FG001|Participant Flow|Sequence 2|Abediterol pressurised metered-dose inhaler (pMDI) 0.05 μg, followed by Abediterol pMDI 0.156 μg; Abediterol dry powder inhaler (DPI) 0.156 μg; Abediterol pMDI 2.5 μg; Placebo; Abediterol DPI 2.5 μg
11277482|NCT02777827|FG002|Participant Flow|Sequence 3|Abediterol pressurised metered-dose inhaler (pMDI) 0.156 μg, followed by Abediterol pMDI 2.5 μg; Abediterol pMDI 0.05 μg; Abediterol dry powder inhaler (DPI) 2.5 μg; Abediterol DPI 0.156 μg; Placebo
11277483|NCT02777827|FG003|Participant Flow|Sequence 4|Abediterol dry powder inhaler (DPI) 2.5 μg, followed by Placebo; Abediterol pressurised metered-dose inhaler (pMDI) 2.5 μg; Abediterol DPI 0.156 μg; Abediterol pMDI 0.156 μg; Abediterol pMDI 0.05 μg
11277484|NCT02777827|FG004|Participant Flow|Sequence 5|Abediterol pressurised metered-dose inhaler (pMDI) 2.5 μg, followed by Abediterol dry powder inhaler (DPI) 2.5 μg; Abediterol pMDI 0.156 μg; Placebo; Abediterol pMDI 0.05 μg; Abediterol DPI 0.156 μg
11277485|NCT02777827|FG005|Participant Flow|Sequence 6|Placebo, followed by Abediterol dry powder inhaler (DPI) 0.156 μg; Abediterol DPI 2.5 μg; Abediterol pressurised metered-dose inhaler (pMDI) 0.05 μg; Abediterol pMDI 2.5 μg; Abediterol pMDI 0.156 μg
11277486|NCT02777827|OG000|Outcome|Abediterol Dry Powder Inhaler 0.156 μg|Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation)
11277487|NCT02777827|OG001|Outcome|Abediterol Dry Powder Inhaler 2.5 μg|Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation).
11277488|NCT02777827|OG002|Outcome|Abediterol Pressurised Metered-dose Inhaler 0.05μg|Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs).
11277489|NCT02777827|OG003|Outcome|Abediterol Pressurised Metered-dose Inhaler 0.156 μg|Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs).
11277490|NCT02777827|OG004|Outcome|Abediterol Pressurised Metered-dose Inhaler 2.5μg|Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs).
11277491|NCT02777827|OG005|Outcome|Placebo|Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation).
11277492|NCT02777827|EG000|Reported Event|Abediterol Dry Powder Inhaler 0.156 μg|Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation)
11277493|NCT02777827|EG001|Reported Event|Abediterol Dry Powder Inhaler 2.5 μg|Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation).
11277494|NCT02777827|EG002|Reported Event|Abediterol Pressurised Metered-dose Inhaler 0.05μg|Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs).
11277495|NCT02777827|EG003|Reported Event|Abediterol Pressurised Metered-dose Inhaler 0.156 μg|Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs).
11277496|NCT02777827|EG004|Reported Event|Abediterol Pressurised Metered-dose Inhaler 2.5μg|Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs).
11277497|NCT02777827|EG005|Reported Event|Placebo|Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation).
11277498|NCT02777918|BG000|Baseline|Intervention|"6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.~Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks"
11277499|NCT02777918|BG001|Baseline|Control|Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
11277500|NCT02777918|BG002|Baseline|Total|Total of all reporting groups
11277501|NCT02777918|FG000|Participant Flow|Intervention|"6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.~Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks"
11277502|NCT02777918|FG001|Participant Flow|Control|Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
11277503|NCT02777918|OG000|Outcome|Intervention|"6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.~Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks"
11277504|NCT02777918|OG001|Outcome|Control|Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
11277505|NCT02777918|EG000|Reported Event|Intervention|"6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.~Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks"
11277506|NCT02777918|EG001|Reported Event|Control|Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
11277507|NCT02777931|BG000|Baseline|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
11277508|NCT02777931|BG001|Baseline|Placebo|Matching placebo capsules
11277509|NCT02777931|BG002|Baseline|Total|Total of all reporting groups
11277510|NCT02777931|FG000|Participant Flow|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
11277511|NCT02777931|FG001|Participant Flow|Placebo|Matching placebo capsules
11277512|NCT02777931|OG000|Outcome|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
11277513|NCT02777931|OG001|Outcome|Placebo|Matching placebo capsules
11277514|NCT02777931|EG000|Reported Event|NFC-1|Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
11277515|NCT02777931|EG001|Reported Event|Placebo|Matching placebo capsules
11277516|NCT02777944|BG000|Baseline|Intervention|"Access to Motivate: a web-based intervention, in addition to Usual Care~Motivate: a web-based intervention: A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules."
11277517|NCT02777944|BG001|Baseline|Control|Usual Care
11277518|NCT02777944|BG002|Baseline|Total|Total of all reporting groups
11277519|NCT02777944|FG000|Participant Flow|Intervention|"Access to Motivate: a web-based intervention, in addition to Usual Care~Motivate: a web-based intervention: A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules."
11277520|NCT02777944|FG001|Participant Flow|Control|Usual Care
11277521|NCT02777944|OG000|Outcome|Intervention|"Access to Motivate: a web-based intervention, in addition to Usual Care~Motivate: a web-based intervention: A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules."
11277522|NCT02777944|OG001|Outcome|Control|Usual Care
11277523|NCT02777944|EG000|Reported Event|Intervention|"Access to Motivate: a web-based intervention, in addition to Usual Care~Motivate: a web-based intervention: A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules."
11277524|NCT02777944|EG001|Reported Event|Control|Usual Care
11277525|NCT02777970|BG000|Baseline|Tramadol/Dexketoprofen|"Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;~Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose."
11277526|NCT02777970|BG001|Baseline|Tramadol/Paracetamol|"Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;~Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose."
11277527|NCT02777970|BG002|Baseline|Placebo|"Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;~Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose."
11277528|NCT02777970|BG003|Baseline|Total|Total of all reporting groups
11277529|NCT02777970|FG000|Participant Flow|Tramadol/Dexketoprofen|"Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;~Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose."
11277530|NCT02777970|FG001|Participant Flow|Tramadol/Paracetamol|"Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;~Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose."
11092321|NCT01539135|EG001|Reported Event|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
11277531|NCT02777970|FG002|Participant Flow|Placebo|"Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;~Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose."
11277532|NCT02777970|OG000|Outcome|Tramadol/Dexketoprofen|"Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;~Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose."
11277533|NCT02777970|OG001|Outcome|Tramadol/Paracetamol|"Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;~Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose."
11277534|NCT02777970|OG002|Outcome|Placebo|"Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;~Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose."
11277535|NCT02777970|OG001|Outcome|Tramadol/Paracetamol|Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose; Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
11277536|NCT02777970|OG000|Outcome|Tramadol/Dexketoprofen|Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose; Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose.
11277537|NCT02777970|EG000|Reported Event|Tramadol/Dexketoprofen|"Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;~Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose."
11277538|NCT02777970|EG001|Reported Event|Tramadol/Paracetamol|"Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;~Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose."
11277539|NCT02777970|EG002|Reported Event|Placebo|"Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;~Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose."
11092322|NCT01539239|BG000|Baseline|Hydrus Aqueous Implant (Treatment)|"Cataract surgery plus Hydrus Aqueous Implant~Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL."
11092323|NCT01539239|BG001|Baseline|Cataract Surgery (Control)|"Cataract surgery only~Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery."
11277540|NCT02778074|BG000|Baseline|Internet Cognitive Behavioural Therapy|"Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.~Internet cognitive behavioural therapy: A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation."
11287010|NCT02896400|FG002|Participant Flow|BNI+NRT+QL+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11277541|NCT02778074|BG001|Baseline|Moderated Discussion Forum|"In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.~Moderated Discussion Forum: Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program."
11277542|NCT02778074|BG002|Baseline|Total|Total of all reporting groups
11277543|NCT02778074|FG000|Participant Flow|Internet Cognitive Behavioural Therapy|"Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.~Internet cognitive behavioural therapy: A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation."
11277544|NCT02778074|FG001|Participant Flow|Moderated Discussion Forum|"In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.~Moderated Discussion Forum: Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program."
11277545|NCT02778074|OG000|Outcome|Internet Cognitive Behavioural Therapy|"Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.~Internet cognitive behavioural therapy: A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation."
11277546|NCT02778074|OG001|Outcome|Moderated Discussion Forum|"In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.~Moderated Discussion Forum: Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program."
11277547|NCT02778074|EG000|Reported Event|Internet Cognitive Behavioural Therapy|"Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.~Internet cognitive behavioural therapy: A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation."
11277548|NCT02778074|EG001|Reported Event|Moderated Discussion Forum|"In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.~Moderated Discussion Forum: Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program."
11277549|NCT02778100|BG000|Baseline|Nasal Glucagon (NG)|Dose of 3 mg NG administered once to participants with a common cold.
11277550|NCT02778100|BG001|Baseline|NG Plus Oxymetazoline|Dose of 3 mg NG administered once to participants with a common cold, who are taking oxymetazoline.
11277551|NCT02778100|BG002|Baseline|Total|Total of all reporting groups
11277552|NCT02778100|FG000|Participant Flow|Nasal Glucagon (NG) 3 mg (Milligram)|"Period 1:~NG administered once in participants with a common cold.~Period 2: NG administered once in participants who have recovered from a common cold."
11277553|NCT02778100|FG001|Participant Flow|NG 3 mg Plus Oxymetazoline|Period 1 only: NG administered once to participants with a common cold, who are taking oxymetazoline.
11277554|NCT02778100|OG000|Outcome|NG - Common Cold|Dose of 3 mg NG administered once in participants with a common cold.
11277555|NCT02778100|OG001|Outcome|NG - Symptom-Free|Dose of 3 mg NG administered once in participants who have recovered from a common cold.
11277556|NCT02778100|OG002|Outcome|NG - Common Cold+Oxymetazoline|Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
11277557|NCT02778100|EG000|Reported Event|NG- Common Cold|Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold.
11277558|NCT02778100|EG001|Reported Event|NG - Symptom-Free|Dose of 3 mg nasal glucagon (NG) administered once in participants who have recovered from a common cold.
11277559|NCT02778100|EG002|Reported Event|NG - Common Cold+Oxymetazoline|Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold who are taking oxymetazoline.
11277560|NCT02778113|BG000|Baseline|All Participants|In each of four study periods, a single dose of either NG or SC glucagon was administered.
11277561|NCT02778113|FG000|Participant Flow|Sequence 1 (T1/T2/T3/T4)|Treatment (T1) = nasal glucagon (NG) dose of 0.5 milligram (mg), T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = subcutaneous (SC) glucagon dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
11277562|NCT02778113|FG001|Participant Flow|Sequence 2 (T2/T3/T4/T1)|T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
11277563|NCT02778113|FG002|Participant Flow|Sequence 3 (T3/T4/T1/T2)|T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
11277564|NCT02778113|FG003|Participant Flow|Sequence 4 (T4/T1/T2/T3)|T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg, T3 = NG dose of 2 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
11277565|NCT02778113|OG000|Outcome|NG 0.5 mg|Nasal glucagon (NG) dose of 0.5 milligram (mg).
11277566|NCT02778113|OG001|Outcome|NG 1 mg|NG dose of 1 mg.
11277567|NCT02778113|OG002|Outcome|NG 2 mg|NG dose of 2 mg.
11277568|NCT02778113|OG003|Outcome|SC Glucagon 1 mg|Subcutaneous (SC) glucagon dose of 1 mg.
11277569|NCT02778113|OG000|Outcome|NG 0.5 mg|NG dose of 0.5 mg.
11277570|NCT02778113|OG003|Outcome|SC Glucagon 1 mg|SC glucagon dose of 1 mg.
11277571|NCT02778113|EG000|Reported Event|NG 0.5 mg|NG dose of 0.5 mg.
11277572|NCT02778113|EG001|Reported Event|NG 1 mg|NG dose of 1 mg.
11277573|NCT02778113|EG002|Reported Event|NG 2 mg|NG dose of 2 mg.
11277574|NCT02778113|EG003|Reported Event|SC Glucagon 1 mg|SC glucagon dose of 1 mg.
11277575|NCT02778152|BG000|Baseline|Laser Depilation|"Laser depilation to the natal cleft (pilonidal region) monthly for 5 treatments with either an 810nm of Nd:YAG laser dependent on Fitzpatrick skin type and tolerability.~Laser depilation: Laser depilation of natal cleft (pilonidal region)"
11277576|NCT02778152|FG000|Participant Flow|Laser Group|Received 5 laser hair removal treatments spaced every 4 to 6 weeks
11277577|NCT02778152|OG000|Outcome|Laser Group|Received 5 laser hair removal treatments spaced every 4 to 6 weeks
11277578|NCT02778152|EG000|Reported Event|Laser Group|Received 5 laser hair removal treatments spaced every 4 to 6 weeks
11277579|NCT02778555|BG000|Baseline|Validation Sample 1|In Sample 1 (N=186), our 14-item Daily PCS was administered daily for 14 days to replicate the 3-factor structure at the daily level, and to select the ideal 5 items for a brief Daily PCS.
10822105|NCT00074490|FG003|Participant Flow|Arm IVB (6-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11092324|NCT01539239|BG002|Baseline|Total|Total of all reporting groups
11277580|NCT02778555|BG001|Baseline|Validation Sample 2|In Sample 2 (N=209), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
11277581|NCT02778555|BG002|Baseline|Validation Sample 3|In Sample 3 (N=305), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14. In addition, assessments of pain, mood, activity, sleep, energy level, and positive affect were administered daily for the 14-day period.
11277582|NCT02778555|BG003|Baseline|Total|Total of all reporting groups
11277583|NCT02778555|FG000|Participant Flow|Validation Sample 1|In Sample 1 (N=186), our 14-item Daily PCS was administered daily for 14 days to replicate the 3-factor structure at the daily level, and to select the ideal 5 items for a brief Daily PCS.
11277584|NCT02778555|FG001|Participant Flow|Validation Sample 2|In Sample 2 (N=209), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
11277585|NCT02778555|FG002|Participant Flow|Validation Sample 3|In Sample 3 (N=318), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14. In addition, assessments of pain, mood, activity, sleep, energy level, and positive affect were administered daily for the 14-day period.
11277586|NCT02778555|OG000|Outcome|Validation Sample 1|In Sample 1 (N=186), our 14-item Daily PCS was administered daily for 14 days to replicate the 3-factor structure at the daily level, and to select the ideal 5 items for a brief Daily PCS.
11277587|NCT02778555|OG001|Outcome|Validation Sample 2|In Sample 2 (N=209), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
11277588|NCT02778555|OG002|Outcome|Validation Sample 3|In Sample 3 (N=318), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14. In addition, assessments of pain, mood, activity, sleep, energy level, and positive affect were administered daily for the 14-day period.
11277589|NCT02778555|EG000|Reported Event|Validation Sample 1|In Sample 1 (N=186), our 14-item Daily PCS was administered daily for 14 days to replicate the 3-factor structure at the daily level, and to select the ideal 5 items for a brief Daily PCS.
11277590|NCT02778555|EG001|Reported Event|Validation Sample 2|In Sample 2 (N=209), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
11277591|NCT02778555|EG002|Reported Event|Validation Sample 3|In Sample 3 (N=318), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14. In addition, assessments of pain, mood, activity, sleep, energy level, and positive affect were administered daily for the 14-day period.
11277592|NCT02778867|BG000|Baseline|1-Food Elimination Diet (1FED)|"Participants eliminate milk from the diet in Phase 1~1 Food Elimination Diet Therapy"
11277593|NCT02778867|BG001|Baseline|6-Food Elimination Diet (6FED)|"Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1~6 Food Elimination Diet Therapy"
11277594|NCT02778867|BG002|Baseline|Total|Total of all reporting groups
11277595|NCT02778867|FG000|Participant Flow|1-Food Elimination Diet (1FED)|"Participants eliminate milk from the diet in Phase 1~1 Food Elimination Diet Therapy"
11277596|NCT02778867|FG001|Participant Flow|6-Food Elimination Diet (6FED)|"Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1~6 Food Elimination Diet Therapy"
11277597|NCT02778867|FG002|Participant Flow|1FED Non-Responders (6FED)|"Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2~6 Food Elimination Diet Therapy"
11277598|NCT02778867|FG003|Participant Flow|6FED Non-responders (SGC)|"Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2~Fluticasone Propionate, 880 mcg twice daily"
11277599|NCT02778867|OG000|Outcome|1-Food Elimination Diet (1FED)|"Participants eliminate milk from the diet in Phase 1~1 Food Elimination Diet Therapy"
11277600|NCT02778867|OG001|Outcome|6-Food Elimination Diet (6FED)|"Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1~6 Food Elimination Diet Therapy"
11277601|NCT02778867|OG000|Outcome|6FED Non-responders (SGC)|"Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (Flovent HFA) 880 mcg twice daily in Phase 2~Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)"
11277602|NCT02778867|OG000|Outcome|1FED Non-Responders (6FED)|"Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2~6 Food Elimination Diet (after 1FED failure)"
11277603|NCT02778867|EG000|Reported Event|1-Food Elimination Diet (1FED)|"Participants eliminate milk from the diet in Phase 1~1 Food Elimination Diet Therapy"
11277604|NCT02778867|EG001|Reported Event|6-Food Elimination Diet (6FED)|"Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1~6 Food Elimination Diet Therapy"
11277605|NCT02778867|EG002|Reported Event|1FED Non-Responders (6FED)|"Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2~6 Food Elimination Diet (after 1FED failure)"
11277606|NCT02778867|EG003|Reported Event|6FED Non-responders (SGC)|"Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2~Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)"
11277607|NCT02778880|BG000|Baseline|Ketamine|Ketamine 1.5 mg/kg intranasally for one dose
11277608|NCT02778880|BG001|Baseline|Fentanyl|Fentanyl 2 mcg/kg intranasally for one dose
11277609|NCT02778880|BG002|Baseline|Total|Total of all reporting groups
11277610|NCT02778880|FG000|Participant Flow|Ketamine|Ketamine 1.5 mg/kg intranasally for one dose
11277611|NCT02778880|FG001|Participant Flow|Fentanyl|Fentanyl 2 mcg/kg intranasally for one dose
11277612|NCT02778880|OG000|Outcome|Ketamine|Ketamine 1.5 mg/kg intranasally for one dose
11277613|NCT02778880|OG001|Outcome|Fentanyl|Fentanyl 2 mcg/kg intranasally for one dose
11277614|NCT02778880|EG000|Reported Event|Ketamine|Ketamine 1.5 mg/kg intranasally for one dose
11277615|NCT02778880|EG001|Reported Event|Fentanyl|Fentanyl 2 mcg/kg intranasally for one dose
11277616|NCT02778932|BG000|Baseline|ITN and Relaxation|General anesthesia including intubation and muscle relaxation
11277617|NCT02778932|BG001|Baseline|LM Without Relaxation|General anesthesia including laryngeal mask without muscle relaxation
11277618|NCT02778932|BG002|Baseline|Total|Total of all reporting groups
11277619|NCT02778932|FG000|Participant Flow|Intubation|Patients receiving general anesthesia including intubation and muscle Relaxation for pars plana-vitrectomy
11277620|NCT02778932|FG001|Participant Flow|Laryngeal Mask|General anesthesia including laryngeal mask without muscle relaxation
11277621|NCT02778932|OG000|Outcome|ITN Without Relaxation|General anesthesia including intubation and muscle relaxation
11277622|NCT02778932|OG001|Outcome|LM Without Relaxation|General anesthesia including laryngeal mask without muscle relaxation
11277623|NCT02778932|OG000|Outcome|ITN Without Relaxation|"General anesthesia including intubation and muscle Relaxation~Result: Surgeon's satisfaction was 10 [0-10] (Median [Range], Rating Scala: 0 (none) to 10 (maximal))"
11277624|NCT02778932|OG001|Outcome|LM Without Relaxation|"General anesthesia including laryngeal mask without muscle Relaxation~Result: Surgeon's satisfaction was 10 [0-10] (Median [Range], Rating Scala: 0 (none) to 10 (maximal))"
11277625|NCT02778932|EG000|Reported Event|LM Without Relaxation|General anesthesia including laryngeal mask without muscle relaxation
11277626|NCT02778932|EG001|Reported Event|ITN With Relaxation|General anesthesia including intubation and muscle relaxation
11277627|NCT02779075|BG000|Baseline|Cross-over Design|"Subjects will be studied on 2 occasions, in random order.~During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.~During the Saline study day they will be infused with saline as a control"
11277628|NCT02779075|FG000|Participant Flow|First Saline Then Exendin-9,39|First Intervention (Day 1 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed.
11277629|NCT02779075|FG001|Participant Flow|First Exendin-9,39 Then Saline|First Intervention (Day 1 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed.
11277630|NCT02779075|OG000|Outcome|First Saline Then Exendin-9,39|First Intervention (Day 1 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed.
11277631|NCT02779075|OG001|Outcome|First Exendin-9,39 Then Saline|First Intervention (Day 1 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed.
11277632|NCT02779075|EG000|Reported Event|Saline|"0.9% NaCL (saline) intravenously for 6 hours.~Saline: Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline."
11277633|NCT02779075|EG001|Reported Event|Exendin-9,39|"Exendin-9,39 intravenously for 6 hours.~Exendin-9,39: Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery."
11277634|NCT02779166|BG000|Baseline|Intervention|"Received 400mg celecoxib prior to surgery~Celecoxib: Received 400mg celecoxib prior to surgery"
11277635|NCT02779166|BG001|Baseline|Placebo|"Received placebo pill prior to surgery~placebo"
11277636|NCT02779166|BG002|Baseline|Total|Total of all reporting groups
11277637|NCT02779166|FG000|Participant Flow|Intervention|"50 patients received 400mg celecoxib prior to surgery~Celecoxib: Received 400mg celecoxib prior to surgery"
11277638|NCT02779166|FG001|Participant Flow|Placebo|"48 received placebo pill prior to surgery~placebo"
11277639|NCT02779166|OG000|Outcome|Intervention|"50 patients received 400mg celecoxib prior to surgery~Celecoxib: Received 400mg celecoxib prior to surgery"
11277640|NCT02779166|OG001|Outcome|Placebo|"48 received placebo pill prior to surgery~placebo"
11277641|NCT02779166|EG000|Reported Event|Intervention|"50 patients received 400mg celecoxib prior to surgery~Celecoxib: Received 400mg celecoxib prior to surgery"
11277642|NCT02779166|EG001|Reported Event|Placebo|"48 received placebo pill prior to surgery~placebo"
11277643|NCT02779491|BG000|Baseline|Intervention for Two Weeks|"Receipt of the mobile phone application for two weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277644|NCT02779491|BG001|Baseline|Control for Two Weeks|Usual habitual activity - no receipt of mobile phone application for two weeks
11277645|NCT02779491|BG002|Baseline|Intervention for Four Weeks|"Receipt of the mobile phone application for four weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277646|NCT02779491|BG003|Baseline|Control for Four Weeks|Usual habitual activity - no receipt of mobile phone application for four weeks
11277647|NCT02779491|BG004|Baseline|Total|Total of all reporting groups
11277648|NCT02779491|FG000|Participant Flow|Intervention for Two Weeks|"Receipt of the mobile phone application for two weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277649|NCT02779491|FG001|Participant Flow|Control for Two Weeks|Usual habitual activity - no receipt of mobile phone application for two weeks
11277650|NCT02779491|FG002|Participant Flow|Intervention for Four Weeks|"Receipt of the mobile phone application for four weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277651|NCT02779491|FG003|Participant Flow|Control for Four Weeks|Usual habitual activity - no receipt of mobile phone application for four weeks
11277652|NCT02779491|OG000|Outcome|Intervention for Two Weeks|"Receipt of the mobile phone application for two weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277653|NCT02779491|OG001|Outcome|Control for Two Weeks|Usual habitual activity - no receipt of mobile phone application for two weeks
11277654|NCT02779491|OG002|Outcome|Intervention for Four Weeks|"Receipt of the mobile phone application for four weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277655|NCT02779491|OG003|Outcome|Control for Four Weeks|Usual habitual activity - no receipt of mobile phone application for four weeks
11277656|NCT02779491|EG000|Reported Event|Intervention for Two Weeks|"Receipt of the mobile phone application for two weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277657|NCT02779491|EG001|Reported Event|Control for Two Weeks|Usual habitual activity - no receipt of mobile phone application for two weeks
11277658|NCT02779491|EG002|Reported Event|Intervention for Four Weeks|"Receipt of the mobile phone application for four weeks~5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application"
11277659|NCT02779491|EG003|Reported Event|Control for Four Weeks|Usual habitual activity - no receipt of mobile phone application for four weeks
11277660|NCT02779543|BG000|Baseline|Fitbit Charge 2|"Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277661|NCT02779543|BG001|Baseline|Microsoft Band 2|"Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277662|NCT02779543|BG002|Baseline|Total|Total of all reporting groups
11277663|NCT02779543|FG000|Participant Flow|Fitbit Charge 2|"Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277664|NCT02779543|FG001|Participant Flow|Microsoft Band 2|"Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277665|NCT02779543|OG000|Outcome|Fitbit Charge 2|"Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277666|NCT02779543|OG001|Outcome|Microsoft Band 2|"Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277667|NCT02779543|OG001|Outcome|Microsoft Band 2|"Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277668|NCT02779543|EG000|Reported Event|Fitbit Charge 2|"Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277669|NCT02779543|EG001|Reported Event|Microsoft Band 2|"Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.~Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine."
11277670|NCT02780115|BG000|Baseline|Cohort 1: Vehicle Control|Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
11277671|NCT02780115|BG001|Baseline|Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose|Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277672|NCT02780115|BG002|Baseline|Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose|Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277673|NCT02780115|BG003|Baseline|Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose|Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277674|NCT02780115|BG004|Baseline|Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose|Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
11277675|NCT02780115|BG005|Baseline|Total|Total of all reporting groups
11277676|NCT02780115|FG000|Participant Flow|Cohort 1: Vehicle Control|Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
11277677|NCT02780115|FG001|Participant Flow|Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose|Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277678|NCT02780115|FG002|Participant Flow|Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose|Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277679|NCT02780115|FG003|Participant Flow|Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose|Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277680|NCT02780115|FG004|Participant Flow|Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose|Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
11277681|NCT02780115|OG000|Outcome|Cohort 1: Vehicle Control|Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
11277682|NCT02780115|OG001|Outcome|Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose|Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277683|NCT02780115|OG002|Outcome|Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose|Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277684|NCT02780115|OG003|Outcome|Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose|Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277685|NCT02780115|OG004|Outcome|Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose|Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
11277686|NCT02780115|EG000|Reported Event|Cohort 1: Vehicle Control|Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
11277687|NCT02780115|EG001|Reported Event|Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose|Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277688|NCT02780115|EG002|Reported Event|Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose|Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277689|NCT02780115|EG003|Reported Event|Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose|Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
11277690|NCT02780115|EG004|Reported Event|Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose|Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
11277691|NCT02780167|BG000|Baseline|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
11277692|NCT02780167|BG001|Baseline|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
11277693|NCT02780167|BG002|Baseline|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
11277694|NCT02780167|BG003|Baseline|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
11277695|NCT02780167|BG004|Baseline|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
11277696|NCT02780167|BG005|Baseline|Total|Total of all reporting groups
11277697|NCT02780167|FG000|Participant Flow|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
11277698|NCT02780167|FG001|Participant Flow|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
11277699|NCT02780167|FG002|Participant Flow|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
11277700|NCT02780167|FG003|Participant Flow|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
11277701|NCT02780167|FG004|Participant Flow|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
11277702|NCT02780167|OG000|Outcome|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
11277703|NCT02780167|OG001|Outcome|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
11277704|NCT02780167|OG002|Outcome|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
11277705|NCT02780167|OG003|Outcome|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
11277706|NCT02780167|OG004|Outcome|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
11277707|NCT02780167|EG000|Reported Event|Placebo|Participants received matching placebo tablets for a 12-week double-blind treatment period.
11277708|NCT02780167|EG001|Reported Event|PF-04965842 10mg QD|Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
11277709|NCT02780167|EG002|Reported Event|PF-04965842 30mg QD|Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
11277710|NCT02780167|EG003|Reported Event|PF-04965842 100mg QD|Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
11277711|NCT02780167|EG004|Reported Event|PF-04965842 200mg QD|Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
11277712|NCT02780349|BG000|Baseline|Single Arm|WIRION: Embolic Protection System
11277713|NCT02780349|FG000|Participant Flow|WIRION EPS|WIRION: Embolic Protection System
11277714|NCT02780349|OG000|Outcome|Single Arm|WIRION: Embolic Protection System
11277715|NCT02780349|EG000|Reported Event|Single Arm|WIRION: Embolic Protection System
11277716|NCT02780388|BG000|Baseline|Placebo|Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
11277717|NCT02780388|BG001|Baseline|VIB4920 75 mg|Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
11277718|NCT02780388|BG002|Baseline|VIB4920 500 mg|Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
11277719|NCT02780388|BG003|Baseline|VIB4920 1000 mg|Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
11277720|NCT02780388|BG004|Baseline|VIB4920 1500 mg|Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
11277721|NCT02780388|BG005|Baseline|Total|Total of all reporting groups
11277722|NCT02780388|FG000|Participant Flow|Placebo|Participants received a single intravascular (IV) dose of placebo matched to VIB4920 (formerly MEDI4920) once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
11277723|NCT02780388|FG001|Participant Flow|VIB4920 75 mg|Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
11277724|NCT02780388|FG002|Participant Flow|VIB4920 500 mg|Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
11277725|NCT02780388|FG003|Participant Flow|VIB4920 1000 mg|Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
11277726|NCT02780388|FG004|Participant Flow|VIB4920 1500 mg|Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
11277727|NCT02780388|OG000|Outcome|Placebo|Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
11277728|NCT02780388|OG001|Outcome|VIB4920 75 mg|Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
11277729|NCT02780388|OG002|Outcome|VIB4920 500 mg|Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
11277730|NCT02780388|OG003|Outcome|VIB4920 1000 mg|Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
11277731|NCT02780388|OG004|Outcome|VIB4920 1500 mg|Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
11277732|NCT02780388|OG000|Outcome|VIB4920 75 mg|Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
11277733|NCT02780388|OG001|Outcome|VIB4920 500 mg|Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
11277734|NCT02780388|OG002|Outcome|VIB4920 1000 mg|Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
11277735|NCT02780388|OG003|Outcome|VIB4920 1500 mg|Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
11277736|NCT02780388|EG000|Reported Event|Placebo|Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
11277737|NCT02780388|EG001|Reported Event|VIB4920 75 mg|Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
11277738|NCT02780388|EG002|Reported Event|VIB4920 500 mg|Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
11277739|NCT02780388|EG003|Reported Event|VIB4920 1000 mg|Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
11277740|NCT02780388|EG004|Reported Event|VIB4920 1500 mg|Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
11277741|NCT02780622|BG000|Baseline|All Participants|Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
11277742|NCT02780622|FG000|Participant Flow|First Warfarin Then Warfarin and Oseltamivir|Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
11277743|NCT02780622|FG001|Participant Flow|First Warfarin and Oseltamivir Then Warfarin|Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
11277744|NCT02780622|OG000|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
11277745|NCT02780622|OG001|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
11277746|NCT02780622|OG000|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
11277747|NCT02780622|EG000|Reported Event|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
11277748|NCT02780622|EG001|Reported Event|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
11277749|NCT02780661|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
11277750|NCT02780661|FG000|Participant Flow|Denture Cleanser Tablet: Daily Use /Weekly Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 milliliter [mL]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days) in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days); and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 2. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277751|NCT02780661|FG001|Participant Flow|Denture Cleanser Tablet: Weekly Use/ Daily Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of the days) in treatment period 1. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277752|NCT02780661|OG000|Outcome|Denture Cleanser Tablet: Daily Use Period|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277753|NCT02780661|OG001|Outcome|Denture Cleanser Tablet: Weekly Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277754|NCT02780661|OG000|Outcome|Denture Cleanser Tablet: Daily Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277755|NCT02780661|EG000|Reported Event|Denture Cleanser Tablet: Daily Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277756|NCT02780661|EG001|Reported Event|Denture Cleanser Tablet: Weekly Use|Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
11277757|NCT02780687|BG000|Baseline|Cohort A|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277758|NCT02780687|BG001|Baseline|Cohort B|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277759|NCT02780687|BG002|Baseline|Total|Total of all reporting groups
11277760|NCT02780687|FG000|Participant Flow|Cohort A|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277761|NCT02780687|FG001|Participant Flow|Cohort B|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277762|NCT02780687|OG000|Outcome|Cohort A|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277763|NCT02780687|EG000|Reported Event|Cohort A|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11277764|NCT02780687|EG001|Reported Event|Cohort B|Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
11092325|NCT01539239|FG000|Participant Flow|Hydrus Aqueous Implant (Treatment)|"Cataract surgery plus Hydrus Aqueous Implant~Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL."
11277765|NCT02780700|BG000|Baseline|Nintedanib Plus Capecitabine|"Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily.~Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle"
11277766|NCT02780700|FG000|Participant Flow|Nintedanib Plus Capecitabine|"Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily.~Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle"
11277767|NCT02780700|OG000|Outcome|Nintedanib Plus Capecitabine|"Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily.~Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle"
11277768|NCT02780700|EG000|Reported Event|Nintedanib Plus Capecitabine|"Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily.~Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle"
11277769|NCT02780713|BG000|Baseline|All Participants|All enrolled participants who received at least one dose of AZD9496.
11092326|NCT01539239|FG001|Participant Flow|Cataract Surgery (Control)|"Cataract surgery only~Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery."
11277770|NCT02780713|FG000|Participant Flow|Treatment Period 1|Participants received AZD9496 - Variant A (100 mg).
11277771|NCT02780713|FG001|Participant Flow|Treatment Period 2|Participants received AZD9496 - Reference (100 mg).
11277772|NCT02780713|FG002|Participant Flow|Treatment Period 3|Participants received AZD9496 - Variant B (100 mg).
11277773|NCT02780713|FG003|Participant Flow|Treatment Period 4|Participants received AZD9496 - Variant C (100 mg).
11277774|NCT02780713|FG004|Participant Flow|Treatment Period 5|Participants received AZD9496 - Variant B (300 mg).
11277775|NCT02780713|OG000|Outcome|Treatment Period 1|Participants received AZD9496 - Variant A (100 mg).
11277776|NCT02780713|OG001|Outcome|Treatment Period 2|Participants received AZD9496 - Reference (100 mg).
11277777|NCT02780713|OG002|Outcome|Treatment Period 3|Participants received AZD9496 - Variant B (100 mg).
11277778|NCT02780713|OG003|Outcome|Treatment Period 4|Participants received AZD9496 - Variant C (100 mg).
11277779|NCT02780713|OG004|Outcome|Treatment Period 5|Participants received AZD9496 - Variant B (300 mg).
11277780|NCT02780713|OG000|Outcome|DN Ratio - Variant A (100 mg): Ref (100 mg)|Participants received AZD9496 - Variant A (100 mg) in Treatment Period 1.
11277781|NCT02780713|OG001|Outcome|DN Ratio - Variant B (100 mg) : Ref (100 mg)|Participants received AZD9496 - Variant B (100 mg) in Treatment Period 3.
11277782|NCT02780713|OG002|Outcome|DN Ratio - Variant C (100 mg) : Ref (100 mg)|Participants received AZD9496 - Variant C (100 mg) in Treatment 4.
11277783|NCT02780713|OG002|Outcome|AZD9496 - Variant C (100 mg)|Participants received this treatment in Treatment Period 4
11277784|NCT02780713|OG001|Outcome|Treatment Period 3|Participants received AZD9496 - Variant B (100 mg).
11277785|NCT02780713|OG002|Outcome|Treatment Period 4|Participants received AZD9496 - Variant C (100 mg).
11277786|NCT02780713|EG000|Reported Event|Treatment Period 1|Participants received AZD9496 - Variant A (100 mg).
11277787|NCT02780713|EG001|Reported Event|Treatment Period 2|Participants received AZD9496 - Reference (100 mg).
11277788|NCT02780713|EG002|Reported Event|Treatment Period 3|Participants received AZD9496 - Variant B (100 mg).
11277789|NCT02780713|EG003|Reported Event|Treatment Period 4|Participants received AZD9496 - Variant C (100 mg).
11277790|NCT02780713|EG004|Reported Event|Treatment Period 5|Participants received AZD9496 - Variant B (300 mg).
11277791|NCT02780713|EG005|Reported Event|All Participants|All enrolled participants who received at least one dose of AZD9496.
11277792|NCT02780765|BG000|Baseline|Heated Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)"
11277793|NCT02780765|BG001|Baseline|Mist Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier"
11277794|NCT02780765|BG002|Baseline|Total|Total of all reporting groups
11277795|NCT02780765|FG000|Participant Flow|Heated Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)"
11277796|NCT02780765|FG001|Participant Flow|Mist Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier"
11277797|NCT02780765|OG000|Outcome|Heated Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)"
11277798|NCT02780765|OG001|Outcome|Mist Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier"
11277799|NCT02780765|EG000|Reported Event|Heated Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)"
11277800|NCT02780765|EG001|Reported Event|Mist Humidifier Group|"30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.~mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier"
11277801|NCT02780856|BG000|Baseline|Sound and Unsound Teeth|"Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System~Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black & white and luminescent images of each tooth taken.The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277802|NCT02780856|FG000|Participant Flow|Sound and Unsound Teeth|"Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System~Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried. Both black & white and luminescent images will be taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277803|NCT02780856|OG000|Outcome|Sound|"Sound (ICDAS 0) canines or incisors - imaging with the Calcivis System~Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black & white and luminescent images taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277804|NCT02780856|OG001|Outcome|Unsound|"Unsound (ICDAS 2 or 3) molars or premolars - imaging with the Calcivis System~Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black & white and luminescent images taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277805|NCT02780856|OG000|Outcome|Sound and Unsound Teeth|"Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System~Imaging with the Calcivis System: Following identification of both sound and unsound teeth, both black & white and luminescent images were taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277806|NCT02780856|OG000|Outcome|Sound and Unsound Teeth|"Imaging of sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars with the Calcivis System~Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black & white and luminescent images taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11277807|NCT02780856|EG000|Reported Event|Sound and Unsound Teeth|"Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System~Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and images of each tooth taken immediately before and after application of a small amount of disclosing solution. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)"
11287011|NCT02896400|FG003|Participant Flow|NRT+QL|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287012|NCT02896400|FG004|Participant Flow|BNI+QL|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287013|NCT02896400|FG005|Participant Flow|NRT Only|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11287014|NCT02896400|FG006|Participant Flow|BNI+Text|"Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287015|NCT02896400|FG007|Participant Flow|BNI+NRT+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287016|NCT02896400|FG008|Participant Flow|NRT+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287017|NCT02896400|FG009|Participant Flow|BNI+NRT|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11287018|NCT02896400|FG010|Participant Flow|Control|Control arm, no intervention
11277808|NCT02780869|BG000|Baseline|Investigational|HEMOBLAST Bellows
11277809|NCT02780869|BG001|Baseline|Control|Absorbable gelatin sponge, USP with thrombin
11277810|NCT02780869|BG002|Baseline|Total|Total of all reporting groups
11277811|NCT02780869|FG000|Participant Flow|Investigational|"HEMOBLAST Bellows~HEMOBLAST Bellows"
11277812|NCT02780869|FG001|Participant Flow|Control|"Absorbable gelatin sponge, USP with thrombin~Absorbable gelatin sponge, USP with thrombin"
11277813|NCT02780869|OG000|Outcome|Investigational|HEMOBLAST Bellows
11277814|NCT02780869|OG001|Outcome|Control|Absorbable gelatin sponge, USP with thrombin
11277815|NCT02780869|EG000|Reported Event|Investigational|HEMOBLAST Bellows
11277816|NCT02780869|EG001|Reported Event|Control|Absorbable gelatin sponge, USP with thrombin
11277817|NCT02781051|BG000|Baseline|Physical Activity Intervention|"Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.~Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.~Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily.~Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.~Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
11277818|NCT02781051|FG000|Participant Flow|Physical Activity Intervention|"Participants receive a multi-component physical activity intervention for 12 weeks.~Print-based education: All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.~Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.~Active Living Every Day: 12 weekly group educational sessions, facilitated by project interventionists. Topics included: identifying and overcoming barriers, setting goals, and time management.~Facility Access: Subjects had access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
11277819|NCT02781051|OG000|Outcome|Physical Activity Intervention|"Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.~Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.~Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.~Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.~Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
11277820|NCT02781051|OG000|Outcome|Physical Activity Intervention|"Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.~Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.~Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily.~Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.~Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
11277821|NCT02781051|EG000|Reported Event|Physical Activity Intervention|"Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.~Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.~Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily.~Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.~Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
11277822|NCT02781311|BG000|Baseline|Placebo|Two placebo tablets BID at 12-hour intervals for 24 weeks.
11277823|NCT02781311|BG001|Baseline|Setipiprant|Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
11277824|NCT02781311|BG002|Baseline|Finasteride|Finasteride 1 mg tablet, orally, once daily for 24 weeks.
11277825|NCT02781311|BG003|Baseline|Total|Total of all reporting groups
11277826|NCT02781311|FG000|Participant Flow|Placebo|Two placebo tablets, twice daily (BID) at 12-hour intervals for 24 weeks.
11277827|NCT02781311|FG001|Participant Flow|Setipiprant|Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
11277828|NCT02781311|FG002|Participant Flow|Finasteride|Finasteride 1 mg tablet, orally, once daily for 24 weeks.
11277829|NCT02781311|OG000|Outcome|Placebo|Two placebo tablets BID at 12-hour intervals for 24 weeks.
11277830|NCT02781311|OG001|Outcome|Setipiprant|Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
11277831|NCT02781311|EG000|Reported Event|Placebo|Two placebo tablets BID at 12-hour intervals for 24 weeks.
11277832|NCT02781311|EG001|Reported Event|Setipiprant|Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
11277833|NCT02781311|EG002|Reported Event|Finasteride|Finasteride 1 mg tablet, orally, once daily for 24 weeks.
11277834|NCT02781324|BG000|Baseline|Ultrasonic Bone Scalpel Group|"Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion~Ultrasonic Bone Scalpel"
11277835|NCT02781324|BG001|Baseline|Standard of Care Group|"Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion"
11277836|NCT02781324|BG002|Baseline|Total|Total of all reporting groups
11277837|NCT02781324|FG000|Participant Flow|Ultrasonic Bone Scalpel Group|"Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion~Ultrasonic Bone Scalpel"
11277838|NCT02781324|FG001|Participant Flow|Standard of Care Group|"Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion"
11277839|NCT02781324|OG000|Outcome|Ultrasonic Bone Scalpel Group|"Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion~Ultrasonic Bone Scalpel"
11277840|NCT02781324|OG001|Outcome|Standard of Care Group|"Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion"
11277841|NCT02781324|OG000|Outcome|Ultrasonic Bone Scalpel Group|Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
11277842|NCT02781324|OG001|Outcome|Standard of Care Group|Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
11277843|NCT02781324|EG000|Reported Event|Ultrasonic Bone Scalpel Group|"Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion~Ultrasonic Bone Scalpel"
11277844|NCT02781324|EG001|Reported Event|Standard of Care Group|"Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.~Posterior Spinal Fusion"
11277845|NCT02781454|BG000|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277846|NCT02781454|BG001|Baseline|Mexiletine, 600 Milligrams|"Mexiletine, 600 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277847|NCT02781454|BG002|Baseline|Placebo|"Placebo, by mouth per day for 4 weeks.~Placebo"
11277848|NCT02781454|BG003|Baseline|Total|Total of all reporting groups
11277849|NCT02781454|FG000|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277850|NCT02781454|FG001|Participant Flow|Mexiletine, 600 Milligrams|"Mexiletine, 600 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277851|NCT02781454|FG002|Participant Flow|Placebo|"Placebo, by mouth per day for 4 weeks.~Placebo"
11277852|NCT02781454|OG000|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277853|NCT02781454|OG001|Outcome|Mexiletine, 600 Milligrams|"Mexiletine, 600 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277854|NCT02781454|OG002|Outcome|Placebo|"Placebo, by mouth per day for 4 weeks.~Placebo"
11277855|NCT02781454|EG000|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277856|NCT02781454|EG001|Reported Event|Mexiletine, 600 Milligrams|"Mexiletine, 600 milligrams by mouth per day for 4 weeks.~Mexiletine"
11277857|NCT02781454|EG002|Reported Event|Placebo|"Placebo, by mouth per day for 4 weeks.~Placebo"
11277858|NCT02781480|BG000|Baseline|Low Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at low dose (1 x 10^11 vg/mL)
11277859|NCT02781480|BG001|Baseline|Intermediate Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at intermediate dose (3 x 10^11 vg/mL)
11277860|NCT02781480|BG002|Baseline|High Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at high dose (1 x 10^12 vg/mL)
11277861|NCT02781480|BG003|Baseline|Total|Total of all reporting groups
11277862|NCT02781480|FG000|Participant Flow|Low Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at low dose (1 x 10^11 vg/mL)
11277863|NCT02781480|FG001|Participant Flow|Intermediate Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at intermediate dose (3 x 10^11 vg/mL)
11277864|NCT02781480|FG002|Participant Flow|High Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at high dose (1 x 10^12 vg/mL)
11277865|NCT02781480|OG000|Outcome|Low Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at low dose (1 x 10^11 vg/mL)
11277866|NCT02781480|OG001|Outcome|Intermediate Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at intermediate dose (3 x 10^11 vg/mL)
11277867|NCT02781480|OG002|Outcome|High Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at high dose (1 x 10^12 vg/mL)
11277868|NCT02781480|EG000|Reported Event|Low Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at low dose (1 x 10^11 vg/mL)
11277869|NCT02781480|EG001|Reported Event|Intermediate Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at intermediate dose (3 x 10^11 vg/mL)
11277870|NCT02781480|EG002|Reported Event|High Dose AAV-RPE65|Unilateral sub-retinal injection of AAV2/5-OPTIRPE65 in a total volume of no more than 1mL at high dose (1 x 10^12 vg/mL)
11277871|NCT02781558|BG000|Baseline|SOF/VEL|SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks
11277872|NCT02781558|BG001|Baseline|SOF/VEL + RBV|SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11277873|NCT02781558|BG002|Baseline|Total|Total of all reporting groups
11277874|NCT02781558|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
11277875|NCT02781558|FG001|Participant Flow|SOF/VEL + RBV|SOF/VEL 400/100 mg FDC tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11277876|NCT02781558|OG000|Outcome|SOF/VEL|SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks
11277877|NCT02781558|OG001|Outcome|SOF/VEL + RBV|SOF/VEL 400/100 mg FDC tablet once daily RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11277878|NCT02781558|OG001|Outcome|SOF/VEL + RBV|SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11277879|NCT02781558|EG000|Reported Event|SOF/VEL|SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks
11277880|NCT02781558|EG001|Reported Event|SOF/VEL + RBV|SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
11277881|NCT02781571|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
11277882|NCT02781571|FG000|Participant Flow|SOF/VEL|Sofosbuvir/Velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
11277883|NCT02781571|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
11277884|NCT02781571|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
11277885|NCT02781610|BG000|Baseline|ERR-10|"ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277886|NCT02781610|BG001|Baseline|ERR-14|"ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277887|NCT02781610|BG002|Baseline|NERR-14|"NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277888|NCT02781610|BG003|Baseline|NERR-21|"NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277889|NCT02781610|BG004|Baseline|Total|Total of all reporting groups
11277890|NCT02781610|FG000|Participant Flow|ERR-10|"ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277891|NCT02781610|FG001|Participant Flow|ERR-14|"ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277892|NCT02781610|FG002|Participant Flow|NERR-14|"NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277893|NCT02781610|FG003|Participant Flow|NERR-21|"NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277894|NCT02781610|OG000|Outcome|ERR-10|"ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277895|NCT02781610|OG001|Outcome|ERR-14|"ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277896|NCT02781610|OG000|Outcome|NERR-14|"NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277897|NCT02781610|OG001|Outcome|NERR-21|"NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277898|NCT02781610|EG000|Reported Event|ERR-10|"ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277899|NCT02781610|EG001|Reported Event|ERR-14|"ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277900|NCT02781610|EG002|Reported Event|NERR-14|"NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277901|NCT02781610|EG003|Reported Event|NERR-21|"NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention.~Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention."
11277902|NCT02781649|BG000|Baseline|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
11277903|NCT02781649|BG001|Baseline|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
11277904|NCT02781649|BG002|Baseline|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
11277905|NCT02781649|BG003|Baseline|Total|Total of all reporting groups
11277906|NCT02781649|FG000|Participant Flow|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
11277907|NCT02781649|FG001|Participant Flow|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
11277908|NCT02781649|FG002|Participant Flow|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
11277909|NCT02781649|OG000|Outcome|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
11277910|NCT02781649|OG001|Outcome|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
11277911|NCT02781649|OG002|Outcome|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
11277912|NCT02781649|EG000|Reported Event|Donor Genotype 1a no Resistance or 1b|"Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks"
11277913|NCT02781649|EG001|Reported Event|Donor Genotype 1a With Resistance|"Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses"
11277914|NCT02781649|EG002|Reported Event|Donor Genotype 2 or 3|"Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks~Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks~Sofosbuvir: Sofosbuvir 400 mg daily"
11277915|NCT02781818|BG000|Baseline|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
11277916|NCT02781818|BG001|Baseline|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
11277917|NCT02781818|BG002|Baseline|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
11277918|NCT02781818|BG003|Baseline|Total|Total of all reporting groups
11277919|NCT02781818|FG000|Participant Flow|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.
11277920|NCT02781818|FG001|Participant Flow|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
11277921|NCT02781818|FG002|Participant Flow|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1 mL of sterile normal saline solution.
11277922|NCT02781818|OG000|Outcome|Triamcinolone Acetonide 10mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
11277923|NCT02781818|OG001|Outcome|Triamcinolone Acetonide 40mg/mL|Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
11277924|NCT02781818|OG002|Outcome|Normal Saline Placebo|Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
11277925|NCT02781818|EG000|Reported Event|Triamcinolone Acetonide 10mg/mL|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.~Triamcinolone Acetonide 10mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use."
11277926|NCT02781818|EG001|Reported Event|Triamcinolone Acetonide 40mg/mL|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.~Triamcinolone Acetonide 40mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use."
11277927|NCT02781818|EG002|Reported Event|Normal Saline Placebo|"Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of sterile normal saline solution.~Normal Saline: Normal saline 0.1mL will be administered intralesionally at the selected site."
11277928|NCT02781844|BG000|Baseline|Cohort I: Treatment A/B or Treatment B/A|Participants received either 25 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively.
11277929|NCT02781844|BG001|Baseline|Cohort II: Treatment C/B or Treatment B/C|Participants received either 50 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively.
11277930|NCT02781844|BG002|Baseline|Cohort III: Treatment D/E or Treatment E/D|Participants received either 25 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively.
11277931|NCT02781844|BG003|Baseline|Cohort IV: Treatment F/E or Treatment E/F|Participants receive either 50 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively.
11277932|NCT02781844|BG004|Baseline|Total|Total of all reporting groups
11277933|NCT02781844|FG000|Participant Flow|Cohort I: Treatment A / B|Participants received 25 microgram (mcg) rhPTH(1-84) twice daily (BID) with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) once daily (QD) with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of greater than or equal to (>=) 5 days but less than or equal to (<=) 30 days between the administration of 25 mcg BID and 100 mcg QD rhPTH(1-84).
11277934|NCT02781844|FG001|Participant Flow|Cohort I: Treatment B / A|Participants received 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 25 mcg BID rhPTH(1-84).
11277935|NCT02781844|FG002|Participant Flow|Cohort II: Treatment C / B|Participants received 50 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 50 mcg BID and 100 mcg QD rhPTH(1-84).
11277936|NCT02781844|FG003|Participant Flow|Cohort II: Treatment B / C|Participants received 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 50 mcg BID rhPTH(1-84).
11277937|NCT02781844|FG004|Participant Flow|Cohort III: Treatment D / E|Participants received 25 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 25 mcg BID and 100 mcg QD rhPTH(1-84).
11277938|NCT02781844|FG005|Participant Flow|Cohort III: Treatment E / D|Participants received 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 25 mcg BID rhPTH(1-84).
11092327|NCT01539239|OG000|Outcome|Hydrus Aqueous Implant (Treatment)|"Cataract surgery plus Hydrus Aqueous Implant~Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL."
11277939|NCT02781844|FG006|Participant Flow|Cohort IV: Treatment F / E|Participants received 50 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 50 mcg BID and 100 mcg QD rhPTH(1-84).
11277940|NCT02781844|FG007|Participant Flow|Cohort IV: Treatment E / F|Participants received 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 50 mcg BID rhPTH(1-84).
11277941|NCT02781844|OG000|Outcome|Cohort I: Treatment A|Participants received 25 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in cohort I.
11277942|NCT02781844|OG001|Outcome|Cohort II: Treatment C|Participants received 50 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in Cohort II.
11277943|NCT02781844|OG002|Outcome|Cohort I+II: Treatment B|Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period.
11277944|NCT02781844|OG003|Outcome|Cohort III: Treatment D|Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
11277945|NCT02781844|OG004|Outcome|Cohort IV: Treatment F|Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV.
11277946|NCT02781844|OG005|Outcome|Cohort III + IV: Treatment E|Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period.
11277947|NCT02781844|OG002|Outcome|Cohort III: Treatment D|Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
11277948|NCT02781844|OG003|Outcome|Cohort IV: Treatment F|Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV.
11277949|NCT02781844|EG000|Reported Event|Cohort I: Treatment A|Participants received 25 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in cohort I.
11277950|NCT02781844|EG001|Reported Event|Cohort II: Treatment C|Participants received 50 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in Cohort II.
11277951|NCT02781844|EG002|Reported Event|Cohort I+II: Treatment B|Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period.
11277952|NCT02781844|EG003|Reported Event|Cohort III: Treatment D|Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
11277953|NCT02781844|EG004|Reported Event|Cohort IV: Treatment F|Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV.
11277954|NCT02781844|EG005|Reported Event|Cohort III + IV: Treatment E|Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period.
11277955|NCT02782065|BG000|Baseline|Pediatric Patients With Asthma|"34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years~Not an interventional study"
11277956|NCT02782065|FG000|Participant Flow|Pediatric Patients With Asthma|"34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years~Not an interventional study"
11277957|NCT02782065|OG000|Outcome|Pediatric Patients With Asthma|"34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years~Not an interventional study"
11277958|NCT02782065|OG000|Outcome|Pediatric Patients With Asthma|"29 patients aged 2 to 18 years~Not an interventional study"
11277959|NCT02782065|EG000|Reported Event|Pediatric Patients With Asthma|"34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years~Not an interventional study"
11277960|NCT02782169|BG000|Baseline|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
11277961|NCT02782169|BG001|Baseline|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
11277962|NCT02782169|BG002|Baseline|Total|Total of all reporting groups
11277963|NCT02782169|FG000|Participant Flow|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
11277964|NCT02782169|FG001|Participant Flow|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
11277965|NCT02782169|OG000|Outcome|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
11277966|NCT02782169|OG001|Outcome|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
11277967|NCT02782169|EG000|Reported Event|Pregabalin|Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
11277968|NCT02782169|EG001|Reported Event|Placebo|Placebo: Matching placebo capsule with excipient to match Pregabalin
11277969|NCT02782325|BG000|Baseline|Active FMT, Then Open Label FMT|Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277970|NCT02782325|BG001|Baseline|Placebo FMT, Then Open Label FMT|Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277971|NCT02782325|BG002|Baseline|Total|Total of all reporting groups
11277972|NCT02782325|FG000|Participant Flow|Active FMT, Then Open Label FMT|Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277973|NCT02782325|FG001|Participant Flow|Placebo FMT, Then Open Label FMT|Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277974|NCT02782325|FG002|Participant Flow|Open Label FMT Period|Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277975|NCT02782325|OG000|Outcome|Randomized Phase: Active FMT|Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277976|NCT02782325|OG001|Outcome|Randomized Phase: Placebo|Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277977|NCT02782325|OG002|Outcome|Open Label FMT|Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277978|NCT02782325|EG000|Reported Event|Randomized Phase: Active FMT|Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277979|NCT02782325|EG001|Reported Event|Randomized Phase: Placebo|Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277980|NCT02782325|EG002|Reported Event|Open Label FMT|Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
11277981|NCT02782364|BG000|Baseline|Faecal Incontinence|Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 16 patients will undergo fast-fill measurement first and another 16 patients will have step-wise measurement first
11277982|NCT02782364|FG000|Participant Flow|Stepwise First, Then Fast-fill|Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo stepwise measurement first and another half of the patients will have stepwise measurement first. Patients in this arm underwent stepwise, followed by a two minute rest, then fast fill, followed by a two minute rest, and then by manometry
11277983|NCT02782364|FG001|Participant Flow|Fast-fill First, Then Stepwise|Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo fast-fill measurement first and another half of the patients will have step-wise measurement first. Patient min this arm underwent fast fill, followed by a two minute rest, then step wise, followed by a two minute rest, and then by manometry
11277984|NCT02782364|OG000|Outcome|Stepwise|Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
11092328|NCT01539239|OG001|Outcome|Cataract Surgery (Control)|"Cataract surgery only~Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery."
11277985|NCT02782364|OG001|Outcome|Fast-fill|Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
11277986|NCT02782364|OG000|Outcome|Faecal Incontinence|"Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 18 patients will undergo fast-fill measurement first and another 18 patients will have step-wise measurement first.~This study is classed as observational as the randomisation is solely the order in which the two tests are performed. The test itself can be performed at can be performed at different rates and this study is to evaluate the two"
11277987|NCT02782364|EG000|Reported Event|Stepwise First, Then Fast-fill|"Stepwise First, Then Fast-fill measurement. Observational study where patients with faecal incontinence undergo two AAR measurements; first with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo stepwise measurement first and another half of the patients will have stepwise measurement first. Patients in this arm underwent stepwise, followed by a two minute rest, then fast fill, followed by a two minute rest, and then by manometry~Previous Work has been carried out looking at the sequence has shown no difference in the order. Therefore to keep consistency this method has been continued and results combined"
11277988|NCT02782364|EG001|Reported Event|Fast-fill First, Then Stepwise|"Fast-fill measurement then Stepwise measurement. Observational study where patients with faecal incontinence undergo two AAR measurements; with the newer fast-fill technique and the second with the original step-wise technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo fast-fill measurement first and another half of the patients will have step-wise measurement first. Patient min this arm underwent fast fill, followed by a two minute rest, then step wise, followed by a two minute rest, and then by manometry.~Previous Work has been carried out looking at the sequence has shown no difference in the order. Therefore to keep consistency this method has been continued and results combined"
11277989|NCT02782377|BG000|Baseline|Pelvic Floor Dysfunction|Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
11277990|NCT02782377|FG000|Participant Flow|Pelvic Floor Dysfunction|Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
11277991|NCT02782377|OG000|Outcome|Pre-Rair|AAR performed Prior to Rectal distension
11277992|NCT02782377|OG001|Outcome|Post-RAIR|AAR performed after rectal distension
11277993|NCT02782377|EG000|Reported Event|Pelvic Floor Dysfunction|Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
11277994|NCT02782676|BG000|Baseline|Subjects Received OVD (Bacterial and/or Animal-Derived)|"Subject received study OVD (Bacterial and/or Animal Derived) in either eye.~(NOTE: subject numbers includes both the paired-eyes and non-paired eye participants)"
11277995|NCT02782676|FG000|Participant Flow|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
11277996|NCT02782676|FG001|Participant Flow|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
11277997|NCT02782676|OG000|Outcome|Investigational Healon5 OVD (Bacterially-Derived)|"Subject received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
11277998|NCT02782676|OG001|Outcome|Approved Healon5 OVD (Animal-Derived)|"Subjects received investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
11277999|NCT02782676|EG000|Reported Event|Investigational Healon5 OVD|"Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Investigational Healon5 OVD: ophthalmic viscosurgical device"
11278000|NCT02782676|EG001|Reported Event|Approved Healon5 OVD|"Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye.~Healon5 OVD: ophthalmic viscosurgical device"
11278001|NCT02782780|BG000|Baseline|Monitor Only|Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures.
11278002|NCT02782780|BG001|Baseline|CBTi|"CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced.~Cognitive Behavioral Therapy for Insomnia (CBTi): CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long."
11278003|NCT02782780|BG002|Baseline|Total|Total of all reporting groups
11278004|NCT02782780|FG000|Participant Flow|Monitor Only|Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures.
11278005|NCT02782780|FG001|Participant Flow|CBTi|"CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced.~Cognitive Behavioral Therapy for Insomnia (CBTi): CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long."
11278006|NCT02782780|OG000|Outcome|Monitor Only|Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures.
11278007|NCT02782780|OG001|Outcome|CBTi|"CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced.~Cognitive Behavioral Therapy for Insomnia (CBTi): CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long."
11278008|NCT02782780|EG000|Reported Event|Monitor Only|Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures.
11278009|NCT02782780|EG001|Reported Event|CBTi|"CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced.~Cognitive Behavioral Therapy for Insomnia (CBTi): CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long."
11278010|NCT02782923|BG000|Baseline|Cervical Surgical Patients|Participants who have undergone cervical spine surgery
11278011|NCT02782923|FG000|Participant Flow|Cervical Surgical Patients|Participants who have undergone cervical spine surgery
11278012|NCT02782923|OG000|Outcome|Cervical Surgical Patients|Participants who have undergone cervical spine surgery
11278013|NCT02782923|EG000|Reported Event|Cervical Surgical Patients|Participants who have undergone cervical spine surgery
11278014|NCT02783027|BG000|Baseline|SleepTrackTXT2|Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
11278015|NCT02783027|BG001|Baseline|Text-Message Assessments Only|Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
11278016|NCT02783027|BG002|Baseline|Total|Total of all reporting groups
11278017|NCT02783027|FG000|Participant Flow|SleepTrackTXT2|Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
11092329|NCT01539239|EG000|Reported Event|Hydrus Aqueous Implant (Treatment)|"Cataract surgery plus Hydrus Aqueous Implant~Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL."
11092330|NCT01539239|EG001|Reported Event|Cataract Surgery (Control)|"Cataract surgery only~Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery."
11278018|NCT02783027|FG001|Participant Flow|Text-Message Assessments Only|Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
11278019|NCT02783027|OG000|Outcome|SleepTrackTXT2|Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
11278020|NCT02783027|OG001|Outcome|Text-Message Assessments Only|Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
11278021|NCT02783027|EG000|Reported Event|SleepTrackTXT2|Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
11278022|NCT02783027|EG001|Reported Event|Text-Message Assessments Only|Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
11278023|NCT02783066|BG000|Baseline|"PulseFlow Group"|"Eligible subjects will try a new offloading boot for 4 weeks~Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow"
11278024|NCT02783066|FG000|Participant Flow|"PulseFlow Group"|"Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks~Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow"
11278025|NCT02783066|OG000|Outcome|"PulseFlow Group"|"Eligible subjects will try a new offloading boot for 4 weeks~Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow"
11278026|NCT02783066|OG000|Outcome|"PulseFlow Group"|"Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks~PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow"
11278027|NCT02783066|EG000|Reported Event|"PulseFlow Group"|"Eligible subjects will try a new offloading boot for 4 weeks~Offloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow"
11278028|NCT02783170|BG000|Baseline|Simultaneous Vaccination Arm|"In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278029|NCT02783170|BG001|Baseline|Sequential Vaccination Arm|"In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 21 days later, they will receive the Tdap vaccine during study visit 4.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278030|NCT02783170|BG002|Baseline|Total|Total of all reporting groups
11278031|NCT02783170|FG000|Participant Flow|Simultaneous Vaccination Arm|"In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278032|NCT02783170|FG001|Participant Flow|Sequential Vaccination Arm|"In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278033|NCT02783170|OG000|Outcome|Simultaneous Vaccination Arm|"In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278034|NCT02783170|OG001|Outcome|Sequential Vaccination Arm|"In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278035|NCT02783170|OG000|Outcome|Recruited Subjects|In the study arm, this includes all subjects that were recruited and enrolled into the study.
11278036|NCT02783170|EG000|Reported Event|Simultaneous Vaccination Arm|"In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278037|NCT02783170|EG001|Reported Event|Sequential Vaccination Arm|"In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.~Tetanus, Diphtheria, and Pertussis Vaccine~2016-2017 Quadrivalent Inactivated Influenza Vaccine~2017-2018 Quadrivalent Inactivated Influenza Vaccine"
11278038|NCT02783443|BG000|Baseline|General Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.~General anesthesia: General anesthesia"
11278039|NCT02783443|BG001|Baseline|Regional Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.~Regional anesthesia: Regional anesthesia"
11278040|NCT02783443|BG002|Baseline|Total|Total of all reporting groups
11278041|NCT02783443|FG000|Participant Flow|General Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.~General anesthesia: General anesthesia"
11278042|NCT02783443|FG001|Participant Flow|Regional Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.~Regional anesthesia: Regional anesthesia"
11278043|NCT02783443|OG000|Outcome|General Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.~General anesthesia: General anesthesia"
11278044|NCT02783443|OG001|Outcome|Regional Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.~Regional anesthesia: Regional anesthesia"
11278045|NCT02783443|EG000|Reported Event|General Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.~General anesthesia: General anesthesia"
11278046|NCT02783443|EG001|Reported Event|Regional Anesthesia|"Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.~Regional anesthesia: Regional anesthesia"
11278047|NCT02783469|BG000|Baseline|GoDARTS|Participants of the DOLORisk Dundee baseline survey
11278048|NCT02783469|FG000|Participant Flow|GoDARTS|Participants of the baseline DOLORisk Dundee survey
11278049|NCT02783469|OG000|Outcome|GoDARTS|Participants of the DOLORisk Dundee baseline survey
11278050|NCT02783469|EG000|Reported Event|GoDARTS|Participants of the DOLORisk Dundee baseline survey
11278051|NCT02783573|BG000|Baseline|Placebo|Participants received placebo film-coated oral tablets once daily.
11278052|NCT02783573|BG001|Baseline|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11278053|NCT02783573|BG002|Baseline|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11278054|NCT02783573|BG003|Baseline|Total|Total of all reporting groups
11278055|NCT02783573|FG000|Participant Flow|Placebo|Participants received placebo film-coated oral tablets once daily.
11278056|NCT02783573|FG001|Participant Flow|Lanabecestat 20 Milligrams (mg)|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11278057|NCT02783573|FG002|Participant Flow|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11278058|NCT02783573|OG000|Outcome|Placebo|Participants received placebo film-coated oral tablets once daily.
11278059|NCT02783573|OG001|Outcome|Lanabecestat 20 mg|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
10822106|NCT00074490|FG004|Participant Flow|Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11278060|NCT02783573|OG002|Outcome|Lanabecestat 50 mg|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11278061|NCT02783573|OG000|Outcome|Lanabecestat|Participants received Lanabecestat film-coated tablets orally.
11278062|NCT02783573|EG000|Reported Event|Placebo-Period 1|Participants received placebo film-coated oral tablets once daily.
11278063|NCT02783573|EG001|Reported Event|Lanabecestat 20 Mg-Period 1|Participants received lanabecestat 20 mg film-coated oral tablets once daily.
11278064|NCT02783573|EG002|Reported Event|Lanabecestat 50 Mg-Period 1|Participants received lanabecestat 50 mg film-coated oral tablets once daily.
11278065|NCT02783573|EG003|Reported Event|Lanabecestat 20 Mg-Period 2|Participants from placebo group were randomized to receive lanabecestat 20 mg film-coated oral tablets once daily.
11278066|NCT02783573|EG004|Reported Event|Lanabecestat 50 Mg-Period 2|Participants from placebo group were randomized to receive lanabecestat 50 mg film-coated oral tablets once daily.
11278067|NCT02783599|BG000|Baseline|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered intravenously IV on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278068|NCT02783599|FG000|Participant Flow|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278069|NCT02783599|OG000|Outcome|Olaratumab|Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
11278070|NCT02783599|OG000|Outcome|Olaratumab|Olaratumab 20 mg/kg administered IV on Day 1 and Day 8 of Cycle 1.
11278071|NCT02783599|OG000|Outcome|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278072|NCT02783599|OG000|Outcome|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered IV on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg olaratumab administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278073|NCT02783599|OG000|Outcome|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered IV on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278074|NCT02783599|OG000|Outcome|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 of Cycle 1, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3-7: olaratumab 15 mg/kg olaratumab administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278075|NCT02783599|OG000|Outcome|Olaratumab|Cycle 1: olaratumab 20 mg/kg administered IV on Day 1 and Day 8.
11278076|NCT02783599|OG000|Outcome|Olaratumab + Doxorubicin|"Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.~Cycle 3: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1."
11278077|NCT02783599|EG000|Reported Event|Olaratumab + Doxorubicin|"Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.~Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1.~Cycle 3-7: olaratumab15mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1."
11278078|NCT02783729|BG000|Baseline|Placebo|Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278079|NCT02783729|BG001|Baseline|Zolpidem Tartrate Extended Release 6.25 mg|Participants received zolpidem tartrate extended release (ZOL ER) 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278080|NCT02783729|BG002|Baseline|Lemborexant 5 mg|Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278081|NCT02783729|BG003|Baseline|Lemborexant 10 mg|Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278082|NCT02783729|BG004|Baseline|Total|Total of all reporting groups
11278083|NCT02783729|FG000|Participant Flow|Placebo|Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278084|NCT02783729|FG001|Participant Flow|Zolpidem Tartrate Extended Release 6.25 mg|Participants received zolpidem tartrate extended release (ZOL ER) 6.25 milligram (mg) and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278085|NCT02783729|FG002|Participant Flow|Lemborexant 5 mg|Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278086|NCT02783729|FG003|Participant Flow|Lemborexant 10 mg|Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278087|NCT02783729|OG000|Outcome|Placebo|Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278088|NCT02783729|OG001|Outcome|Lemborexant 5 mg|Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278089|NCT02783729|OG002|Outcome|Lemborexant 10 mg|Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278090|NCT02783729|OG000|Outcome|Zolpidem Tartrate Extended Release 6.25 mg|Participants received zolpidem tartrate extended release (ZOL ER) 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278091|NCT02783729|OG000|Outcome|Zolpidem Tartrate Extended Release 6.25 mg|Participants received ZOL ER 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278092|NCT02783729|OG001|Outcome|Zolpidem Tartrate Extended Release 6.25 mg|Participants received zolpidem tartrate extended release (ZOL ER) 6.25 milligram (mg) and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278093|NCT02783729|OG002|Outcome|Lemborexant 5 mg|Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278094|NCT02783729|OG003|Outcome|Lemborexant 10 mg|Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278095|NCT02783729|EG000|Reported Event|Placebo|Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278096|NCT02783729|EG001|Reported Event|Zolpidem Tartrate Extended Release 6.25 mg|Participants received zolpidem tartrate extended release (ZOL ER) 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
11278097|NCT02783729|EG002|Reported Event|Lemborexant 5 mg|Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278098|NCT02783729|EG003|Reported Event|Lemborexant 10 mg|Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
11278099|NCT02783729|EG004|Reported Event|Run -in Period Placebo|Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once on each night for 7 consecutive nights up to Baseline (Day 1), immediately before the time the participant intended to try to sleep of run-in period.
11278100|NCT02783768|BG000|Baseline|Total|"This is a randomized crossover study. Participants were randomized to two groups, which differed by order of the exposure to e-cigarette versus sham: (1) e-cigarette first, followed by sham, or (2) sham first, followed by e-cigarette. All participants were both exposed and unexposed."
11278101|NCT02783768|FG000|Participant Flow|E-cigarette First|Participants will undergo the e-cigarette exposure prior to the first two MRI measures, and then they will undergo the sham exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.
11278102|NCT02783768|FG001|Participant Flow|Sham First|Participants will undergo the sham exposure prior to the first two MRI measures, and then they will undergo the e-cigarette exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.
11278103|NCT02783768|OG000|Outcome|Exposed to E-cigarette|Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.
11278104|NCT02783768|OG001|Outcome|Unexposed (Sham)|Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.
11278105|NCT02783768|EG000|Reported Event|E-cigarette First|Participants will undergo the e-cigarette exposure prior to the first two MRI measures, and then they will undergo the sham exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.
11278106|NCT02783768|EG001|Reported Event|Sham First|Participants will undergo the sham exposure prior to the first two MRI measures, and then they will undergo the e-cigarette exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.
11278107|NCT02783820|BG000|Baseline|Pooled Placebo|Pooled placebo from all cohorts (2 per cohort = 6)
11278108|NCT02783820|BG001|Baseline|MMV390048 40 mg|MMV390048 40 mg, tablets, single dose
11278109|NCT02783820|BG002|Baseline|MMV390048 80 mg|MMV390048 80 mg, tablets, single dose
11278110|NCT02783820|BG003|Baseline|MMV390048 120 mg|MMV390048 120 mg, tablets, single dose
11278111|NCT02783820|BG004|Baseline|Total|Total of all reporting groups
11278112|NCT02783820|FG000|Participant Flow|Pooled Placebo|Pooled placebo from all cohorts (2 per cohort = 6)
11278113|NCT02783820|FG001|Participant Flow|MMV390048 40 mg|MMV390048 40 mg, tablets, single dose
11278114|NCT02783820|FG002|Participant Flow|MMV390048 80 mg|MMV390048 80 mg, tablets, single dose
11278115|NCT02783820|FG003|Participant Flow|MMV390048 120 mg|MMV390048 120 mg, tablets, single dose
11278116|NCT02783820|OG000|Outcome|Pooled Placebo|Pooled placebo from all cohorts (2 per cohort = 6)
11278117|NCT02783820|OG001|Outcome|MMV390048 40 mg|MMV390048 40 mg, tablets, single dose
11278118|NCT02783820|OG002|Outcome|MMV390048 80 mg|MMV390048 80 mg, tablets, single dose
11278119|NCT02783820|OG003|Outcome|MMV390048 120 mg|MMV390048 120 mg, tablets, single dose
11278120|NCT02783820|EG000|Reported Event|Pooled Placebo|Pooled placebo from all cohorts (2 per cohort = 6)
11278121|NCT02783820|EG001|Reported Event|MMV390048 40 mg|MMV390048 40 mg, tablets, single dose
11278122|NCT02783820|EG002|Reported Event|MMV390048 80 mg|MMV390048 80 mg, tablets, single dose
11278123|NCT02783820|EG003|Reported Event|MMV390048 120 mg|MMV390048 120 mg, tablets, single dose
11278124|NCT02783898|BG000|Baseline|Study|"All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.~AliveCor Heart Monitor: Smart phone based ECG event recorder"
11278125|NCT02783898|BG001|Baseline|Control|All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
11278126|NCT02783898|BG002|Baseline|Total|Total of all reporting groups
11278127|NCT02783898|FG000|Participant Flow|Study|"All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.~AliveCor Heart Monitor: Smart phone based ECG event recorder"
11278128|NCT02783898|FG001|Participant Flow|Control|All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
11287019|NCT02896400|FG011|Participant Flow|BNI+NRT+QL|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11278129|NCT02783898|OG000|Outcome|Study|"All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.~AliveCor Heart Monitor: Smart phone based ECG event recorder"
11278130|NCT02783898|OG001|Outcome|Control|All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
11278131|NCT02783898|OG000|Outcome|Study Group|The AliveCor heart monitor was easy to use
11278132|NCT02783898|OG000|Outcome|Study Group|Questionnaire compliance
11278133|NCT02783898|EG000|Reported Event|Study|"All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.~AliveCor Heart Monitor: Smart phone based ECG event recorder"
11278134|NCT02783898|EG001|Reported Event|Control|All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
11278135|NCT02783911|BG000|Baseline|Mineral Trioxide Aggregate|"Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth~MTA: Mineral Trioxide Aggregate grey paste"
11278136|NCT02783911|BG001|Baseline|Ferric Sulfate|"Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth~Ferric Sulfate: Ferric Sulfate paste"
11278137|NCT02783911|BG002|Baseline|Total|Total of all reporting groups
11278138|NCT02783911|FG000|Participant Flow|Mineral Trioxide Aggregate|"Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth~MTA: Mineral Trioxide Aggregate grey paste"
11278139|NCT02783911|FG001|Participant Flow|Ferric Sulfate|"Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth~Ferric Sulfate: Ferric Sulfate paste"
11278140|NCT02783911|OG000|Outcome|Mineral Trioxide Aggregate|"Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth~MTA: Mineral Trioxide Aggregate grey paste"
11278141|NCT02783911|OG001|Outcome|Ferric Sulfate|"Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth~Ferric Sulfate: Ferric Sulfate paste"
10822107|NCT00074490|FG005|Participant Flow|Healthy Donors|"Donate donor immune cells for recipients.~No data was collected from the donor population."
11092331|NCT01539291|BG000|Baseline|IDL+R to IDL|Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.
11278142|NCT02783911|EG000|Reported Event|Mineral Trioxide Aggregate|"Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth~MTA: Mineral Trioxide Aggregate grey paste"
11278143|NCT02783911|EG001|Reported Event|Ferric Sulfate|"Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth~Ferric Sulfate: Ferric Sulfate paste"
11278144|NCT02783950|BG000|Baseline|GC (Decipher) Arm|If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
11278145|NCT02783950|BG001|Baseline|Usual-Care-Based (UC) Arm|If enrolled during the UC period, only the CAPRA-S results will be provided.
11278146|NCT02783950|BG002|Baseline|Total|Total of all reporting groups
11278147|NCT02783950|FG000|Participant Flow|GC (Decipher) Arm|If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
11278148|NCT02783950|FG001|Participant Flow|Usual-Care-Based (UC) Arm|If enrolled during the UC period, only the CAPRA-S results will be provided.
11278149|NCT02783950|OG000|Outcome|GC (Decipher) Arm|If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
11278150|NCT02783950|OG001|Outcome|Usual-Care-Based (UC) Arm|If enrolled during the UC period, only the CAPRA-S results will be provided.
11278151|NCT02783950|EG000|Reported Event|GC (Decipher) Arm|If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
11278152|NCT02783950|EG001|Reported Event|Usual-Care-Based (UC) Arm|If enrolled during the UC period, only the CAPRA-S results will be provided.
11278153|NCT02784106|BG000|Baseline|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
11278154|NCT02784106|BG001|Baseline|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11278155|NCT02784106|BG002|Baseline|Total|Total of all reporting groups
11278156|NCT02784106|FG000|Participant Flow|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
11278157|NCT02784106|FG001|Participant Flow|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11278158|NCT02784106|FG002|Participant Flow|Placebo/M2951: Open-Label Extension Period|Participants who received placebo matched to M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
11278159|NCT02784106|FG003|Participant Flow|M2951/M2951: Open-Label Extension Period|Participants who received M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
11278160|NCT02784106|OG000|Outcome|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
11278161|NCT02784106|OG001|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11278162|NCT02784106|OG000|Outcome|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11278163|NCT02784106|EG000|Reported Event|Placebo: Double-Blind Treatment Period|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
11278164|NCT02784106|EG001|Reported Event|M2951: Double-Blind Treatment Period|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
11278165|NCT02784106|EG002|Reported Event|Placebo/M2951: Open-Label Extension Period|Participants who received placebo matched to M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
11092332|NCT01539291|BG001|Baseline|Placebo+R (PD) to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278166|NCT02784106|EG003|Reported Event|M2951/M2951: Open-Label Extension Period|Participants who received M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open-label extension period.
11278167|NCT02784275|BG000|Baseline|3 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 3 mg CHP~Cyclo-Z"
11278168|NCT02784275|BG001|Baseline|9 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 9 mg CHP~Cyclo-Z"
11278169|NCT02784275|BG002|Baseline|15 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 15 mg CHP~Cyclo-Z"
11278170|NCT02784275|BG003|Baseline|Placebo|"Placebo~Placebo"
11278171|NCT02784275|BG004|Baseline|Total|Total of all reporting groups
11278172|NCT02784275|FG000|Participant Flow|3 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 3 mg CHP~Cyclo-Z"
11278173|NCT02784275|FG001|Participant Flow|9 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 9 mg CHP~Cyclo-Z"
11278174|NCT02784275|FG002|Participant Flow|15 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 15 mg CHP~Cyclo-Z"
11278175|NCT02784275|FG003|Participant Flow|Placebo|"Placebo~Placebo"
11278176|NCT02784275|OG000|Outcome|3 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 3 mg CHP~Cyclo-Z"
11278177|NCT02784275|OG001|Outcome|9 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 9 mg CHP~Cyclo-Z"
11278178|NCT02784275|OG002|Outcome|15 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 15 mg CHP~Cyclo-Z"
11278179|NCT02784275|OG003|Outcome|Placebo|"Placebo~Placebo"
11278180|NCT02784275|EG000|Reported Event|3 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 3 mg CHP~Cyclo-Z"
11278181|NCT02784275|EG001|Reported Event|9 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 9 mg CHP~Cyclo-Z"
11278182|NCT02784275|EG002|Reported Event|15 mg CHP Plus 23 mg Zinc|"Cyclo-Z containing 23 mg zinc plus 15 mg CHP~Cyclo-Z"
11278183|NCT02784275|EG003|Reported Event|Placebo|"Placebo~Placebo"
11278184|NCT02784431|BG000|Baseline|Treated|Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
11278185|NCT02784431|FG000|Participant Flow|Treated|Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
11278186|NCT02784431|OG000|Outcome|Treated|Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
11278187|NCT02784431|EG000|Reported Event|Treated|Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
11278188|NCT02784444|BG000|Baseline|Placebo|"Matching Placebo capsule taken once daily for 360 days~Placebo: Placebo capsules"
11278189|NCT02784444|BG001|Baseline|MSDC-0602K 62.5 mg|"MSDC-0602K 62.5 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278190|NCT02784444|BG002|Baseline|MSDC-0602K 125 mg|"MSDC-0602K 125 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278191|NCT02784444|BG003|Baseline|MSDC-0602K 250 mg|"MSDC-0602K 250 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278192|NCT02784444|BG004|Baseline|Total|Total of all reporting groups
11278193|NCT02784444|FG000|Participant Flow|Placebo|"Matching Placebo capsule taken once daily for 360 days~Placebo: Placebo capsules"
11278194|NCT02784444|FG001|Participant Flow|MSDC-0602K 62.5 mg|"MSDC-0602K 62.5 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278195|NCT02784444|FG002|Participant Flow|MSDC-0602K 125 mg|"MSDC-0602K 125 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278196|NCT02784444|FG003|Participant Flow|MSDC-0602K 250 mg|"MSDC-0602K 250 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278197|NCT02784444|OG000|Outcome|Placebo|"Matching Placebo capsule taken once daily for 360 days~Placebo: Placebo capsules"
11278198|NCT02784444|OG001|Outcome|MSDC-0602K 62.5 mg|"MSDC-0602K 62.5 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278199|NCT02784444|OG002|Outcome|MSDC-0602K 125 mg|"MSDC-0602K 125 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278200|NCT02784444|OG003|Outcome|MSDC-0602K 250 mg|"MSDC-0602K 250 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278201|NCT02784444|EG000|Reported Event|Placebo|"Matching Placebo capsule taken once daily for 360 days~Placebo: Placebo capsules"
11278202|NCT02784444|EG001|Reported Event|MSDC-0602K 62.5 mg|"MSDC-0602K 62.5 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278203|NCT02784444|EG002|Reported Event|MSDC-0602K 125 mg|"MSDC-0602K 125 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278204|NCT02784444|EG003|Reported Event|MSDC-0602K 250 mg|"MSDC-0602K 250 mg taken once daily for 360 days~MSDC-0602K: MSDC-0602K capsules"
11278205|NCT02784548|BG000|Baseline|Virtual Reality|Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
11278206|NCT02784548|FG000|Participant Flow|Virtual Reality|Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
11278207|NCT02784548|OG000|Outcome|Virtual Reality|Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
11278208|NCT02784548|OG001|Outcome|Mirror Therapy|Mirror Therapy comparison group
11278209|NCT02784548|EG000|Reported Event|Virtual Reality|Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
11278210|NCT02784587|BG000|Baseline|Stellate Ganglion Block|"All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.~Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion."
11278211|NCT02784587|FG000|Participant Flow|Stellate Ganglion Block|"All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.~Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection."
11278212|NCT02784587|OG000|Outcome|Stellate Ganglion Block|"All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.~Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle)."
11278213|NCT02784587|EG000|Reported Event|Stellate Ganglion Block|"All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.~Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle)."
11278214|NCT02784613|BG000|Baseline|Ospemifene Open Label|"60 mg ospemifene daily for 20 weeks~Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia"
11278215|NCT02784613|FG000|Participant Flow|Ospemifene Open Label|"60 mg ospemifene daily for 20 weeks~Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia"
11278216|NCT02784613|OG000|Outcome|Open Label|"60 mg ospemifene daily for 20 weeks~Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia"
11278217|NCT02784613|EG000|Reported Event|Open Label|"60 mg ospemifene daily for 20 weeks~Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia"
11278218|NCT02784834|BG000|Baseline|Dimethyl Fumarate (DMF)|Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
11278219|NCT02784834|FG000|Participant Flow|Dimethyl Fumarate (DMF)|Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
11278220|NCT02784834|OG000|Outcome|Dimethyl Fumarate (DMF)|Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
11278221|NCT02784834|EG000|Reported Event|Dimethyl Fumarate (DMF)|Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
11278222|NCT02784925|BG000|Baseline|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
11278223|NCT02784925|FG000|Participant Flow|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
11278224|NCT02784925|OG000|Outcome|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
11278225|NCT02784925|EG000|Reported Event|Fatty Liver Subjects|Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
11278226|NCT02785159|BG000|Baseline|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278227|NCT02785159|BG001|Baseline|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11278228|NCT02785159|BG002|Baseline|IDP 118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Lotion"
11278229|NCT02785159|BG003|Baseline|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Cream"
11278230|NCT02785159|BG004|Baseline|Total|Total of all reporting groups
11278231|NCT02785159|FG000|Participant Flow|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278232|NCT02785159|FG001|Participant Flow|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11278233|NCT02785159|FG002|Participant Flow|IDP 118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Lotion"
11278234|NCT02785159|FG003|Participant Flow|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Cream"
11278235|NCT02785159|OG000|Outcome|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278236|NCT02785159|OG001|Outcome|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11278237|NCT02785159|OG002|Outcome|IDP 118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Lotion"
11278238|NCT02785159|OG003|Outcome|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Cream"
11278239|NCT02785159|EG000|Reported Event|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278240|NCT02785159|EG001|Reported Event|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11278241|NCT02785159|EG002|Reported Event|IDP 118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Lotion"
11278242|NCT02785159|EG003|Reported Event|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Cream"
11278243|NCT02785172|BG000|Baseline|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278244|NCT02785172|BG001|Baseline|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278245|NCT02785172|BG002|Baseline|IDP-118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Vehicle"
11278246|NCT02785172|BG003|Baseline|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Vehicle"
11278247|NCT02785172|BG004|Baseline|Total|Total of all reporting groups
11278248|NCT02785172|FG000|Participant Flow|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278249|NCT02785172|FG001|Participant Flow|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278250|NCT02785172|FG002|Participant Flow|IDP-118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Vehicle"
11278251|NCT02785172|FG003|Participant Flow|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Vehicle"
11278252|NCT02785172|OG000|Outcome|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278253|NCT02785172|OG001|Outcome|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278254|NCT02785172|OG002|Outcome|IDP-118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Vehicle"
11278255|NCT02785172|OG003|Outcome|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Vehicle"
11278256|NCT02785172|EG000|Reported Event|IDP-118 Lotion|"Lotion~IDP-118 Lotion: Lotion"
11278257|NCT02785172|EG001|Reported Event|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278258|NCT02785172|EG002|Reported Event|IDP-118 Vehicle Lotion|"Lotion~IDP-118 Vehicle Lotion: Vehicle"
11278259|NCT02785172|EG003|Reported Event|IDP-118 Vehicle Cream|"Cream~IDP-118 Vehicle Cream: Vehicle"
11278260|NCT02785185|BG000|Baseline|IDP-122 Lotion|"Lotion~IDP-122 Lotion: Lotion"
11278261|NCT02785185|BG001|Baseline|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278262|NCT02785185|BG002|Baseline|IDP-122 Vehicle Lotion|"Lotion~IDP-122 Vehicle Lotion: Vehicle"
11278263|NCT02785185|BG003|Baseline|IDP-122 Vehicle Cream|"Cream~IDP-122 Vehicle Cream: Vehicle"
11278264|NCT02785185|BG004|Baseline|Total|Total of all reporting groups
11278265|NCT02785185|FG000|Participant Flow|IDP-122 Lotion|"Lotion~IDP-122 Lotion: Lotion"
11278266|NCT02785185|FG001|Participant Flow|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278267|NCT02785185|FG002|Participant Flow|IDP-122 Vehicle Lotion|"Lotion~IDP-122 Vehicle Lotion: Vehicle"
11278268|NCT02785185|FG003|Participant Flow|IDP-122 Vehicle Cream|"Cream~IDP-122 Vehicle Cream: Vehicle"
11278269|NCT02785185|OG000|Outcome|IDP-122 Lotion|"Lotion~IDP-122 Lotion: Lotion"
11278270|NCT02785185|OG001|Outcome|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278271|NCT02785185|OG002|Outcome|IDP-122 Vehicle Lotion|"Lotion~IDP-122 Vehicle Lotion: Vehicle"
11278272|NCT02785185|OG003|Outcome|IDP-122 Vehicle Cream|"Cream~IDP-122 Vehicle Cream: Vehicle"
11278273|NCT02785185|EG000|Reported Event|IDP-122 Lotion|"Lotion~IDP-122 Lotion: Lotion"
11278274|NCT02785185|EG001|Reported Event|Ultravate Cream|"Cream~Ultravate Cream: Cream"
11278275|NCT02785185|EG002|Reported Event|IDP-122 Vehicle Lotion|"Lotion~IDP-122 Vehicle Lotion: Vehicle"
11278276|NCT02785185|EG003|Reported Event|IDP-122 Vehicle Cream|"Cream~IDP-122 Vehicle Cream: Vehicle"
11278277|NCT02785354|BG000|Baseline|Dabigatran|Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278278|NCT02785354|BG001|Baseline|Rivaroxaban|Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278279|NCT02785354|BG002|Baseline|Vitamin K Antagonists|Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278280|NCT02785354|BG003|Baseline|Total|Total of all reporting groups
11278281|NCT02785354|FG000|Participant Flow|Dabigatran|Patients with a first dispensing of dabigatran in 2013 for NVAF.
11278282|NCT02785354|FG001|Participant Flow|Rivaroxaban|Patients with a first dispensing of rivaroxaban in 2013 for NVAF.
11278283|NCT02785354|FG002|Participant Flow|Vitamin K Antagonists|Patients with a first dispensing of VKA in 2013 for NVAF.
11278284|NCT02785354|OG000|Outcome|Dabigatran (Dabigatran vs VKA)|Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278285|NCT02785354|OG001|Outcome|VKA (Dabigatran vs VKA)|Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278286|NCT02785354|OG002|Outcome|Rivaroxaban (Rivaroxaban vs VKA)|Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278287|NCT02785354|OG003|Outcome|VKA (Rivaroxaban vs VKA)|Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
11278288|NCT02785354|EG000|Reported Event|Dabigatran|Patients with a first dispensing of dabigatran in 2013 for NVAF.
11278289|NCT02785354|EG001|Reported Event|Rivaroxaban|Patients with a first dispensing of rivaroxaban in 2013 for NVAF.
11278290|NCT02785354|EG002|Reported Event|Vitamin K Antagonists|Patients with a first dispensing of VKA in 2013 for NVAF.
11092333|NCT01539291|BG002|Baseline|Placebo+R to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11092334|NCT01539291|BG003|Baseline|Total|Total of all reporting groups
11278291|NCT02785406|BG000|Baseline|Suvorexant|"Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.~suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM."
11278292|NCT02785406|BG001|Baseline|Placebo|"Subjects will receive placebo once daily at 10 PM.~Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM."
11278293|NCT02785406|BG002|Baseline|Total|Total of all reporting groups
11278294|NCT02785406|FG000|Participant Flow|Suvorexant|"Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.~suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM."
11278295|NCT02785406|FG001|Participant Flow|Placebo|"Subjects will receive placebo once daily at 10 PM.~Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM."
11278296|NCT02785406|OG000|Outcome|Suvorexant|"Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.~suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM."
11278297|NCT02785406|OG001|Outcome|Placebo|"Subjects will receive placebo once daily at 10 PM.~Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM."
11278298|NCT02785406|EG000|Reported Event|Suvorexant|"Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.~suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM."
11278299|NCT02785406|EG001|Reported Event|Placebo|"Subjects will receive placebo once daily at 10 PM.~Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM."
11278300|NCT02785432|BG000|Baseline|Sham Low Level Laser|"Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.~Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered."
11278301|NCT02785432|BG001|Baseline|Active Low Level Laser|"Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Areas for administration and contact will otherwise be consistent with the sham group.~Active low level laser: Active treatment will be delivered using the time, contact, and energy exposures described in the arm description."
11278302|NCT02785432|BG002|Baseline|Total|Total of all reporting groups
11287020|NCT02896400|FG012|Participant Flow|Text Only|"Registration in SmokefreeText (Text)~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287021|NCT02896400|FG013|Participant Flow|QL+Text|"Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287022|NCT02896400|FG014|Participant Flow|BNI Only|"Brief Negotiated Interview (BNI)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior"
11278303|NCT02785432|FG000|Participant Flow|Sham Low Level Laser|"Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.~Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered."
11278304|NCT02785432|FG001|Participant Flow|Active Low Level Laser|Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
11278305|NCT02785432|OG000|Outcome|Sham Low Level Laser|"Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.~Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered."
11278306|NCT02785432|OG001|Outcome|Active Low Level Laser|Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
11278307|NCT02785432|EG000|Reported Event|Sham Low Level Laser|"Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.~Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered."
11278308|NCT02785432|EG001|Reported Event|Active Low Level Laser|Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
11278309|NCT02785458|BG000|Baseline|Usual Care|Subjects will receive the current standard of care.
11278310|NCT02785458|BG001|Baseline|EMC2 Strategy|"Subjects will receive the EMC2 Strategy. See description of strategy below.~EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up."
11278311|NCT02785458|BG002|Baseline|Total|Total of all reporting groups
11278312|NCT02785458|FG000|Participant Flow|Usual Care|Subjects will receive the current standard of care.
11278313|NCT02785458|FG001|Participant Flow|EMC2 Strategy|"Subjects will receive the EMC2 Strategy. See description of strategy below.~EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up."
11278314|NCT02785458|OG000|Outcome|Usual Care|Subjects will receive the current standard of care.
11278315|NCT02785458|OG001|Outcome|EMC2 Strategy|"Subjects will receive the EMC2 Strategy. See description of strategy below.~EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up."
11278316|NCT02785458|EG000|Reported Event|Usual Care|Subjects will receive the current standard of care.
11278317|NCT02785458|EG001|Reported Event|EMC2 Strategy|"Subjects will receive the EMC2 Strategy. See description of strategy below.~EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up."
11278318|NCT02785588|BG000|Baseline|3.0 T Neonatal MRI Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure"
11092335|NCT01539291|FG000|Participant Flow|IDL+R to IDL 150 mg|Participants received IDL 150 mg tablet twice daily plus rituximab (R) (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278319|NCT02785588|FG000|Participant Flow|3.0 T Neonatal MRI Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure"
11278320|NCT02785588|OG000|Outcome|3.0 T Neonatal MRI Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure"
11215019|NCT02296242|BG004|Baseline|Cohort-expansion RAS(-) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215020|NCT02296242|BG005|Baseline|Total|Total of all reporting groups
11215021|NCT02296242|FG000|Participant Flow|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215022|NCT02296242|FG001|Participant Flow|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215023|NCT02296242|FG002|Participant Flow|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215024|NCT02296242|FG003|Participant Flow|Cohort-expansion RAS(+) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215025|NCT02296242|FG004|Participant Flow|Cohort-expansion RAS(-) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215026|NCT02296242|OG000|Outcome|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215027|NCT02296242|OG001|Outcome|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215028|NCT02296242|OG002|Outcome|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215029|NCT02296242|OG003|Outcome|Cohort-expansion RAS(+) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215030|NCT02296242|OG004|Outcome|Cohort-expansion RAS(-) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215031|NCT02296242|OG000|Outcome|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215032|NCT02296242|OG001|Outcome|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11278321|NCT02785588|EG000|Reported Event|3.0 T Neonatal MRI Scanner|"All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.~3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure"
11278322|NCT02785770|BG000|Baseline|Overall Study|All participants who were randomized to receive Moxifloxacin first, placebo first, PF-04447943 100 mg first and PF-04447943 25 mg first in intervention period 1.
11278323|NCT02785770|FG000|Participant Flow|Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg|Participants received a single oral dose of Moxifloxacin 400 milligram (mg) tablet on Day 1 in the first intervention period; followed by a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
11278324|NCT02785770|FG001|Participant Flow|PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg|Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in the first intervention period; followed by a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the second intervention period; then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
11278325|NCT02785770|FG002|Participant Flow|Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin|Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 100 mg on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the third intervention period; and then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
11278326|NCT02785770|FG003|Participant Flow|PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo|Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 25 mg on Day 1 in the second intervention period; then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the third intervention period; and then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
11278327|NCT02785770|OG000|Outcome|Moxifloxacin 400 mg|Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278328|NCT02785770|OG001|Outcome|Placebo|Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278329|NCT02785770|OG000|Outcome|PF-04447943 25 mg|Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278330|NCT02785770|OG001|Outcome|PF-04447943 100 mg|Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278331|NCT02785770|OG002|Outcome|Placebo|Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278332|NCT02785770|OG002|Outcome|Moxifloxacin 400 mg|Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278333|NCT02785770|OG003|Outcome|Placebo|Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278334|NCT02785770|EG000|Reported Event|PF-04447943 25 mg|Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278335|NCT02785770|EG001|Reported Event|PF-04447943 100 mg|Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278336|NCT02785770|EG002|Reported Event|Moxifloxacin 400 mg|Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278337|NCT02785770|EG003|Reported Event|Placebo|Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
11278338|NCT02785900|BG000|Baseline|33A + HMA|"33A plus azacitidine or decitabine~33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278339|NCT02785900|BG001|Baseline|Placebo + HMA|"placebo plus azacitidine or decitabine~placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278340|NCT02785900|BG002|Baseline|Total|Total of all reporting groups
11278341|NCT02785900|FG000|Participant Flow|33A + HMA|"33A plus azacitidine or decitabine~33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278342|NCT02785900|FG001|Participant Flow|Placebo + HMA|"placebo plus azacitidine or decitabine~placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278343|NCT02785900|OG000|Outcome|33A + HMA|"33A plus azacitidine or decitabine~33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278344|NCT02785900|OG001|Outcome|Placebo + HMA|"placebo plus azacitidine or decitabine~placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278345|NCT02785900|EG000|Reported Event|33A + HMA|"33A plus azacitidine or decitabine~33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278346|NCT02785900|EG001|Reported Event|Placebo + HMA|"placebo plus azacitidine or decitabine~placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push~azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks~decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks"
11278347|NCT02785913|BG000|Baseline|Arm I (GDC-0032)|"Patients receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Taselisib: Given PO"
11278348|NCT02785913|FG000|Participant Flow|Arm I (GDC-0032)|"Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Taselisib: Given PO"
11278349|NCT02785913|OG000|Outcome|Arm I (GDC-0032)|"Participants receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Taselisib: Given PO"
11278350|NCT02785913|OG000|Outcome|Arm I (GDC-0032)|"Patients receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Taselisib: Given PO"
11278351|NCT02785913|EG000|Reported Event|GDC-0032|GDC-0032
11278352|NCT02785939|BG000|Baseline|Palbociclib|"Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Palbociclib: Given PO"
11278353|NCT02785939|BG001|Baseline|Docetaxel|"Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib.~Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad~Docetaxel~RP56976~Taxotere~Taxotere Injection Concentrate~Laboratory Biomarker Analysis Correlative studies"
11278354|NCT02785939|BG002|Baseline|Total|Total of all reporting groups
11278355|NCT02785939|FG000|Participant Flow|Palbociclib|"Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Palbociclib: Given PO"
11278356|NCT02785939|FG001|Participant Flow|Docetaxel|"Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib.~Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad~Docetaxel~RP56976~Taxotere~Taxotere Injection Concentrate~Laboratory Biomarker Analysis Correlative studies"
11278357|NCT02785939|OG000|Outcome|Palbociclib|"Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Palbociclib: Given PO"
11278358|NCT02785939|OG000|Outcome|Palbociclib|"Participants receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Palbociclib: Given PO"
11278359|NCT02785939|EG000|Reported Event|Palbociclib|"Participants receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Palbociclib: Given PO"
11278360|NCT02785939|EG001|Reported Event|Docetaxel|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib.~Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad~Docetaxel~RP56976~Taxotere~Taxotere Injection Concentrate~Laboratory Biomarker Analysis Correlative studies"
11092336|NCT01539291|FG001|Participant Flow|IDL+R (PD) to IDL 300 mg|Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of progressive disease (PD) and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily. Due to the small number of participants in this group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.
11278361|NCT02786004|BG000|Baseline|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
11278362|NCT02786004|BG001|Baseline|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
11278363|NCT02786004|BG002|Baseline|Total|Total of all reporting groups
11278364|NCT02786004|FG000|Participant Flow|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
11278365|NCT02786004|FG001|Participant Flow|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
11278366|NCT02786004|OG000|Outcome|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
11278367|NCT02786004|OG001|Outcome|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
11278368|NCT02786004|OG000|Outcome|Full Field Digital Mammography|Subjects underwent two-dimensional breast imaging.
11278369|NCT02786004|OG001|Outcome|Digital Breast Tomosynthesis|Subjects underwent three-dimensional breast imaging.
11278370|NCT02786004|EG000|Reported Event|Full Field Digital Mammography|"2-dimensional breast imaging~Full Field Digital Mammography"
11278371|NCT02786004|EG001|Reported Event|Digital Breast Tomosynthesis|"3-dimensional breast imaging~Digital Breast Tomosynthesis"
11287023|NCT02896400|FG015|Participant Flow|QL Only|"Referral to CT Smokers Quitline (QL)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11278372|NCT02786134|BG000|Baseline|Low-dose Methotrexate (LDM)|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278373|NCT02786134|BG001|Baseline|Placebo|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278374|NCT02786134|BG002|Baseline|Total|Total of all reporting groups
11278375|NCT02786134|FG000|Participant Flow|Low-Dose Methotrexate (LDM)|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278376|NCT02786134|FG001|Participant Flow|Placebo|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278377|NCT02786134|OG000|Outcome|Low-Dose Methotrexate (LDM)|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278378|NCT02786134|OG001|Outcome|Placebo|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278379|NCT02786134|EG000|Reported Event|Low-Dose Methotrexate (LDM)|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11092337|NCT01539291|FG002|Participant Flow|Placebo+R (PD) to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278380|NCT02786134|EG001|Reported Event|Placebo|"Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.~PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.~Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months."
11278381|NCT02786355|BG000|Baseline|Maximum and Normal Effort Using Long and Short Frova Bougies|"In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order.~Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered."
11287024|NCT02896400|OG000|Outcome|Brief Negotiated Interview (BNI)|"All 8 arms with Brief Negotiated Interview as an intervention:~BNI only BNI+Nicotine Replacement Therapy (NRT) BNI+Quitline (QL) BNI+Text BNI+NRT+QL BNI+NRT+Text BNI+QL+Text BNI+NRT+QL+Text"
11287025|NCT02896400|OG001|Outcome|Brief Negotiated Interview (BNI) CONTROL|"All 8 arms which did not include the BNI intervention:~NRT+QL+Text NRT+QL NRT+Text NRT QL+Text QL Text Control"
11278382|NCT02786355|FG000|Participant Flow|Maximum and Normal Effort Using Long and Short Frova Bougies|"In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order.~Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered."
11278383|NCT02786355|OG000|Outcome|Maximum Effort: Long|"Squeeze through long Frova bougie with maximum effort~Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered"
11278384|NCT02786355|OG001|Outcome|Normal Effort: Long|"Squeeze through long Frova bougie with normal effort~Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered"
11278385|NCT02786355|OG002|Outcome|Maximum Effort: Short|"Squeeze through short Frova bougie with maximum effort~Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered"
11278386|NCT02786355|OG003|Outcome|Normal Effort: Short|"Squeeze through short Frova bougie with normal effort~Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered"
11278387|NCT02786355|EG000|Reported Event|Maximum and Normal Effort Using Long and Short Frova Bougies|"In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order.~Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered."
11278388|NCT02786719|BG000|Baseline|Single Arm|Single arm study- all participants enrolled in single arm
11092338|NCT01539291|FG003|Participant Flow|Placebo+R to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278389|NCT02786719|FG000|Participant Flow|High Risk Neuroblastoma Patients|This was a single arm study- all participants enrolled in single arm which provided 6 cycles of chemotherapy without prophylactic G-CSF for 4 cycles (1,2,4 and 6), and with G-CSF for stem cell collection after cycle 3, and GM-CSF administration after cycle 5 in preparation for surgical resection.
11278390|NCT02786719|OG000|Outcome|High Risk Neuroblastoma Patients|Single arm study- all participants enrolled in single arm
11278391|NCT02786719|EG000|Reported Event|High Risk Neuroblastoma Patients|Single arm study- all participants enrolled in single arm
11278392|NCT02786771|BG000|Baseline|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
11278393|NCT02786771|BG001|Baseline|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
11278394|NCT02786771|BG002|Baseline|Total|Total of all reporting groups
11278395|NCT02786771|FG000|Participant Flow|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
11278396|NCT02786771|FG001|Participant Flow|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
11278397|NCT02786771|OG000|Outcome|Spire Device Without & With Feedback|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
11287026|NCT02896400|OG002|Outcome|Nicotine Replacement Therapy (NRT)|"All 8 arms with Nicotine Replacement Therapy as an intervention:~NRT only Brief Negotiated Interview (BNI)+NRT NRT+Quitline (QL) NRT+Text BNI+NRT+QL BNI+NRT+Text NRT+QL+Text BNI+NRT+QL+Text"
11287027|NCT02896400|OG003|Outcome|Nicotine Replacement Therapy (NRT) CONTROL|"All 8 arms which did not include the NRT intervention:~BNI+QL+Text BNI+QL BNI+Text BNI Only QL+Text QL Only Text Only Control"
11287028|NCT02896400|OG004|Outcome|Quitline (QL)|"All 8 arms with the Quitline as an intervention:~QL only Brief Negotiated Interview (BNI)+QL Nicotine Replacement Therapy (NRT)+QL QL+Text BNI+NRT+QL BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text"
11278398|NCT02786771|OG001|Outcome|Muse Device & Spire Device no Feedback|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
11278399|NCT02786771|EG000|Reported Event|Group 1|"Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks.~Spire"
11278400|NCT02786771|EG001|Reported Event|Group 2|"Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks.~Spire~Muse headband"
11278401|NCT02786810|BG000|Baseline|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
11278402|NCT02786810|FG000|Participant Flow|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
11278403|NCT02786810|OG000|Outcome|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
11278404|NCT02786810|EG000|Reported Event|Contrast|"All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.~Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound"
11278405|NCT02786836|BG000|Baseline|13C-Methacetin Breath Test (MBT)|For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 for up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
11278406|NCT02786836|FG000|Participant Flow|13C-Methacetin Breath Test (MBT)|For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® molecular correlation spectrometry (MCS) device. After completion of the baseline segment, one 75 milligram (mg) dose of 13C-Methacetin (test substrate) mixed into 150 milliliters (ml) of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 (carbon-13 dioxide) over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 for up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
11278407|NCT02786836|OG000|Outcome|13C-Methacetin Breath Test (MBT)|For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes.
11278408|NCT02786836|OG000|Outcome|13C-Methacetin Breath Test (MBT)|For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
11287029|NCT02896400|OG005|Outcome|Quitline (QL) CONTROL|"All 8 arms which did not include the QL intervention:~BNI+NRT+Text BNI+NRT BNI+Text BNI Only NRT+Text NRT Only Text Only Control"
11287030|NCT02896400|OG006|Outcome|Text|"All 8 arms with Text as an intervention:~Text only Brief Negotiated Interview (BNI)+Text Nicotine Replacement Therapy (NRT)+Text Quitline (QL)+Text BNI+NRT+Text BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text"
11278409|NCT02786836|EG000|Reported Event|13C-Methacetin Breath Test (MBT)|For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
11278410|NCT02786901|BG000|Baseline|Vehicle BID and TID|Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined
11278411|NCT02786901|BG001|Baseline|LE Gel BID|Loteprednol Etabonate Ophthalmic Gel dosed BID
11278412|NCT02786901|BG002|Baseline|LE Gel TID|Loteprednol Etabonate Ophthalmic Gel dosed TID
11278413|NCT02786901|BG003|Baseline|Total|Total of all reporting groups
11278414|NCT02786901|FG000|Participant Flow|Vehicle BID and TID|Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined
11278415|NCT02786901|FG001|Participant Flow|LE Gel BID|Loteprednol Etabonate Ophthalmic Gel dosed BID
11278416|NCT02786901|FG002|Participant Flow|LE Gel TID|Loteprednol Etabonate Ophthalmic Gel dosed TID
11278417|NCT02786901|OG000|Outcome|Vehicle BID and TID|Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined
11278418|NCT02786901|OG001|Outcome|LE Gel BID|Loteprednol Etabonate Ophthalmic Gel dosed BID
11278419|NCT02786901|OG002|Outcome|LE Gel TID|Loteprednol Etabonate Ophthalmic Gel dosed TID
11278420|NCT02786901|EG000|Reported Event|Vehicle BID and TID|Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined
11278421|NCT02786901|EG001|Reported Event|LE Gel BID|Loteprednol Etabonate Ophthalmic Gel dosed BID
11092339|NCT01539291|OG000|Outcome|IDL+R to IDL|Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily. Due to the small number of participants in the IDL+R (PD) to IDL 300 mg group, data from this group were combined with the IDL+R to IDL 150 mg group for Baseline Characteristics and Outcome Measures sections.
11278422|NCT02786901|EG002|Reported Event|LE Gel TID|Loteprednol Etabonate Ophthalmic Gel dosed TID
11278423|NCT02786927|BG000|Baseline|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
11278424|NCT02786927|FG000|Participant Flow|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
11278425|NCT02786927|OG000|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
11278426|NCT02786927|EG000|Reported Event|ELLIPTA|Participants received ELLIPTA inhaler at Visit 1/Visit 2 once daily for 5-9 days.
11278427|NCT02786927|EG001|Reported Event|HandiHaler|Participants received HandiHaler inhaler at Visit 1/ Visit 2 once daily for 5-9 days.
11278428|NCT02786953|BG000|Baseline|Sleep Promotion|"Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.~Sleep Promotion: Behavioral intervention to improve sleep quality and duration."
11278429|NCT02786953|BG001|Baseline|Usual Care|Usual Care
11278430|NCT02786953|BG002|Baseline|Total|Total of all reporting groups
11278431|NCT02786953|FG000|Participant Flow|Sleep Promotion|"Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.~Sleep Promotion: Behavioral intervention to improve sleep quality and duration."
11278432|NCT02786953|FG001|Participant Flow|Usual Care|Usual Care
11278433|NCT02786953|OG000|Outcome|Sleep Promotion|"Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.~Sleep Promotion: Behavioral intervention to improve sleep quality and duration."
11278434|NCT02786953|OG001|Outcome|Usual Care|Usual Care
11278435|NCT02786953|EG000|Reported Event|Sleep Promotion|"Behavioral sleep-promoting intervention, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, as well as needs unique to adolescents with T1D, such as fear of hypoglycemia.~Sleep Promotion: Behavioral intervention to improve sleep quality and duration."
11278436|NCT02786953|EG001|Reported Event|Usual Care|Usual Care
11278437|NCT02787057|BG000|Baseline|Control Group|"IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~ceftazidime: IP ceftazidime 1g QD"
11278438|NCT02787057|BG001|Baseline|Study Group|"IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~moxifloxacin: oral moxifloxacin 400mg QD"
11278439|NCT02787057|BG002|Baseline|Total|Total of all reporting groups
11278440|NCT02787057|FG000|Participant Flow|Control Group|"IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~ceftazidime: IP ceftazidime 1g QD"
11278441|NCT02787057|FG001|Participant Flow|Study Group|"IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~moxifloxacin: oral moxifloxacin 400mg QD"
11278442|NCT02787057|OG000|Outcome|Control Group|"IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~ceftazidime: IP ceftazidime 1g QD"
11278443|NCT02787057|OG001|Outcome|Study Group|"IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~moxifloxacin: oral moxifloxacin 400mg QD"
11278444|NCT02787057|EG000|Reported Event|Control Group|"IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~ceftazidime: IP ceftazidime 1g QD"
11278445|NCT02787057|EG001|Reported Event|Study Group|"IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.~vancomycin: IP vancomycin 1g every 5 days~moxifloxacin: oral moxifloxacin 400mg QD"
11278446|NCT02787083|BG000|Baseline|Mirabegron|"These patients will receive mirabegron 50mg tablets daily for 12 weeks.~Mirabegron"
11278447|NCT02787083|BG001|Baseline|Placebo|"These patients will receive placebo tablets daily for 12 weeks.~Placebo"
11278448|NCT02787083|BG002|Baseline|Total|Total of all reporting groups
11278449|NCT02787083|FG000|Participant Flow|Mirabegron|"These patients will receive mirabegron 50mg tablets daily for 12 weeks.~Mirabegron"
11278450|NCT02787083|FG001|Participant Flow|Placebo|"These patients will receive placebo tablets daily for 12 weeks.~Placebo"
11278451|NCT02787083|OG000|Outcome|Mirabegron|"These patients will receive mirabegron 50mg tablets daily for 12 weeks.~Mirabegron"
11278452|NCT02787083|OG001|Outcome|Placebo|"These patients will receive placebo tablets daily for 12 weeks.~Placebo"
11278453|NCT02787083|EG000|Reported Event|Mirabegron|"These patients will receive mirabegron 50mg tablets daily for 12 weeks.~Mirabegron"
11278454|NCT02787083|EG001|Reported Event|Placebo|"These patients will receive placebo tablets daily for 12 weeks.~Placebo"
11278455|NCT02787291|BG000|Baseline|Ellipse VR ICD and Durata/Optisure Lead|"Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region~Ellipse VR ICD and Durata/Optisure lead: Non-diagnostic MRI Scan sequence of head and chest"
11278456|NCT02787291|FG000|Participant Flow|Ellipse VR ICD and Durata/Optisure Lead|"Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region~Ellipse VR ICD and Durata/Optisure lead: Non-diagnostic MRI Scan sequence of head and chest"
11278457|NCT02787291|OG000|Outcome|Ellipse VR ICD and Durata/Optisure Lead|"Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region~Ellipse VR ICD and Durata/Optisure lead: Non-diagnostic MRI Scan sequence of head and chest"
11278458|NCT02787291|EG000|Reported Event|Ellipse VR ICD and Durata/Optisure Lead|"Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region~Ellipse VR ICD and Durata/Optisure lead: Non-diagnostic MRI Scan sequence of head and chest"
11278459|NCT02787304|BG000|Baseline|SHP626 5 Milligram (mg)|"Subject will be administered 5 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278460|NCT02787304|BG001|Baseline|SHP626 10 Milligram (mg)|"Subject will be administered 10 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
10970519|NCT00910858|OG000|Outcome|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11278461|NCT02787304|BG002|Baseline|SHP626 20 Milligram (mg)|"Subject will be administered 20 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278462|NCT02787304|BG003|Baseline|Placebo (PBO)|"Subject will be administered SHP626 matching PBO capsule by orally once daily in a double-blinded fashion~Placebo: Matching placebo"
11278463|NCT02787304|BG004|Baseline|Total|Total of all reporting groups
11278464|NCT02787304|FG000|Participant Flow|SHP626 5 Milligram (mg)|"Subject will be administered 5 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278465|NCT02787304|FG001|Participant Flow|SHP626 10 Milligram (mg)|"Subject will be administered 10 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278466|NCT02787304|FG002|Participant Flow|SHP626 20 Milligram (mg)|"Subject will be administered 20 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278467|NCT02787304|FG003|Participant Flow|Placebo (PBO)|"Subject will be administered SHP626 matching PBO capsule by orally once daily in a double-blinded fashion~Placebo: Matching placebo"
11278468|NCT02787304|OG000|Outcome|SHP626 5 Milligram (mg)|"Subject will be administered 5 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278469|NCT02787304|OG001|Outcome|SHP626 10 Milligram (mg)|"Subject will be administered 10 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11092340|NCT01539291|OG001|Outcome|Placebo+R (PD) to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278470|NCT02787304|OG002|Outcome|SHP626 20 Milligram (mg)|"Subject will be administered 20 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278471|NCT02787304|OG003|Outcome|Placebo (PBO)|"Subject will be administered SHP626 matching PBO capsule by orally once daily in a double-blinded fashion~Placebo: Matching placebo"
11278472|NCT02787304|EG000|Reported Event|SHP626 5 Milligram (mg)|"Subject will be administered 5 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278473|NCT02787304|EG001|Reported Event|SHP626 10 Milligram (mg)|"Subject will be administered 10 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278474|NCT02787304|EG002|Reported Event|SHP626 20 Milligram (mg)|"Subject will be administered 20 mg SHP626 capsule by orally once daily in a double-blinded fashion~SHP626: 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion"
11278475|NCT02787304|EG003|Reported Event|Placebo (PBO)|"Subject will be administered SHP626 matching PBO capsule by orally once daily in a double-blinded fashion~Placebo: Matching placebo"
11278476|NCT02787564|BG000|Baseline|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
11278477|NCT02787564|BG001|Baseline|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
11278478|NCT02787564|BG002|Baseline|Total|Total of all reporting groups
11278479|NCT02787564|FG000|Participant Flow|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
11278480|NCT02787564|FG001|Participant Flow|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
11278481|NCT02787564|OG000|Outcome|Intervention Group|received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
11278482|NCT02787564|OG001|Outcome|Control Group|did not receive free fresh fruits and vegetables
11278483|NCT02787564|EG000|Reported Event|Free Fruit and Vegetables|"A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.~Intervention Group: The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided."
11278484|NCT02787564|EG001|Reported Event|Control Goup|Control Group: A total of four 24h-food-recall questionnaires will be administered to men (>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.
11278485|NCT02787655|BG000|Baseline|Aerobic Exercise + Cognitive Training Group|Randomized participants attended exercise training sessions and cognitive training sessions
11278486|NCT02787655|BG001|Baseline|Cognitive Training Only Group|Participants will follow the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise.
11278487|NCT02787655|BG002|Baseline|Total|Total of all reporting groups
11278488|NCT02787655|FG000|Participant Flow|Aerobic Exercise + Cognitive Training Group|"Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program~Aerobic exercise + Cognitive Training Group: stationary bicycling"
11278489|NCT02787655|FG001|Participant Flow|Cognitive Training Only Group|"Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises~Cognitive training Only: 20 minutes of cognitive training using Mindfit program"
11278490|NCT02787655|OG000|Outcome|Aerobic Exercise + Cognitive Training Group|"Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program~Aerobic exercise + Cognitive Training Group: stationary bicycling"
11092341|NCT01539291|OG002|Outcome|Placebo+R to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278491|NCT02787655|OG001|Outcome|Cognitive Training Only Group|"Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises~Cognitive training Only: 20 minutes of cognitive training using Mindfit program"
11278492|NCT02787655|EG000|Reported Event|Aerobic Exercise + Cognitive Training Group|"Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program~Aerobic exercise + Cognitive Training Group: stationary bicycling"
11278493|NCT02787655|EG001|Reported Event|Cognitive Training Only Group|"Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises~Cognitive training Only: 20 minutes of cognitive training using Mindfit program"
11278494|NCT02787681|BG000|Baseline|NEMO Gauge|Baseline Characteristics
11278495|NCT02787681|FG000|Participant Flow|NEMO Gauge|"Measurement and adjustment of endotracheal tube position by stylet.~NEMO Gauge: Measurement and adjustment of endotracheal tube position by stylet."
11278496|NCT02787681|OG000|Outcome|NEMO Gauge|"Measurement and adjustment of endotracheal tube position by stylet.~NEMO Gauge: Measurement and adjustment of endotracheal tube position by stylet."
11278497|NCT02787681|EG000|Reported Event|NEMO Gauge|"Measurement and adjustment of endotracheal tube position by stylet.~NEMO Gauge: Measurement and adjustment of endotracheal tube position by stylet."
11278498|NCT02787694|BG000|Baseline|Factor Targeted Walking Training|"Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results~Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches~treadmill"
11278499|NCT02787694|FG000|Participant Flow|Factor Targeted Walking Training|"Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results~Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches~treadmill"
11278500|NCT02787694|OG000|Outcome|Factor Targeted Walking Training|"Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results~Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches~treadmill"
11278501|NCT02787694|EG000|Reported Event|Factor Targeted Walking Training|"Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results~Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches~treadmill"
11278502|NCT02787863|BG000|Baseline|COPD With Prevenar-13 (1)|"33 patients with COPD. Standard therapy with Prevenar-13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine"
11092342|NCT01539291|OG000|Outcome|IDL+R|Participants were randomized to receive IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116.
11278503|NCT02787863|BG001|Baseline|Asthma With Prevenar 13 (2)|"34 patients with asthma. Standard therapy with Prevenar 13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine"
11278504|NCT02787863|BG002|Baseline|COPD With Pneumo-23 (3)|"25 patients with COPD. Standard therapy with Pneumo-23.~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278505|NCT02787863|BG003|Baseline|Asthma With Pneumo-23 (4)|"25 patients with asthma. Standard therapy with Pneumo-23.~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278506|NCT02787863|BG004|Baseline|COPD With Pneumo-23/Prevenar-13 (5)|"32 patients with COPD. Standard therapy, vaccinated with PPV23/PCV13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278507|NCT02787863|BG005|Baseline|Asthma With Pneumo-23/Prevenar-13 (6)|"18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278508|NCT02787863|BG006|Baseline|COPD With Prevenar-13/Pneumo-23 (7)|"25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278509|NCT02787863|BG007|Baseline|Asthma With Prevenar-13/Pneumo-23 (8)|"27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278510|NCT02787863|BG008|Baseline|Total|Total of all reporting groups
11278511|NCT02787863|FG000|Participant Flow|COPD - Prevenar-13 (1)|33 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278512|NCT02787863|FG001|Participant Flow|Asthma - Prevenar-13 (2)|34 patients with asthma. Prevenar-13 (PCV13) vaccination.
11092343|NCT01539291|OG001|Outcome|Placebo+R|Participants were randomized to receive placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116.
11278513|NCT02787863|FG002|Participant Flow|COPD - Pneumo-23 (3)|25 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278514|NCT02787863|FG003|Participant Flow|Asthma - Pneumo-23 (4)|25 patients with asthma. Pneumo-23 (PPV23) vaccination.
11278515|NCT02787863|FG004|Participant Flow|COPD - Pneumo-23/Prevenar-13 (5)|"32 patients with COPD, PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278516|NCT02787863|FG005|Participant Flow|Asthma - Pneumo-23/Prevenar-13 (6)|"18 patients with Asthma. PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278517|NCT02787863|FG006|Participant Flow|COPD - Prevenar-13/Pneumo-23 (7)|"25 patients with COPD. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278518|NCT02787863|FG007|Participant Flow|Asthma - Prevenar-13/Pneumo-23 (8)|"27 patients with Asthma. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278519|NCT02787863|OG000|Outcome|COPD - Prevenar-13 (1)|32 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278520|NCT02787863|OG001|Outcome|Asthma - Prevenar-13 (2)|33 patients with asthma. Prevenar-13 (PCV13) vaccination.
11278521|NCT02787863|OG002|Outcome|COPD - Pneumo-23 (3)|23 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278522|NCT02787863|OG003|Outcome|Asthma - Pneumo-23 (4)|25 patients with asthma. Pneumo-23 (PPV23) vaccination.
11278523|NCT02787863|OG004|Outcome|COPD - Pneumo-23/Prevenar-13 (5)|"32 patients with COPD, PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278524|NCT02787863|OG005|Outcome|Asthma - Pneumo-23/Prevenar-13 (6)|"18 patients with Asthma. PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278525|NCT02787863|OG006|Outcome|COPD - Prevenar-13/Pneumo-23 (7)|"25 patients with COPD. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278526|NCT02787863|OG007|Outcome|Asthma - Prevenar-13/Pneumo-23 (8)|"27 patients with Asthma. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278527|NCT02787863|OG000|Outcome|COPD - Prevenar-13 (9)|32 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278528|NCT02787863|OG001|Outcome|Asthma - Prevenar-13 (10)|33 patients with asthma. Prevenar-13 (PCV13) vaccination.
11278529|NCT02787863|OG002|Outcome|COPD - Pneumo-23 (11)|23 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278530|NCT02787863|OG003|Outcome|Asthma - Pneumo-23 (12)|25 patients with asthma. Pneumo-23 (PPV23) vaccination.
11278531|NCT02787863|OG004|Outcome|COPD - Pneumo-23/Prevenar-13 (13)|"32 patients with COPD, PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278532|NCT02787863|OG005|Outcome|Asthma - Pneumo-23/Prevenar-13 (14)|"18 patients with Asthma. PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278533|NCT02787863|OG006|Outcome|COPD - Prevenar-13/Pneumo-23 (15)|"25 patients with COPD. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11092344|NCT01539291|OG000|Outcome|IDL+R to IDL|Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily.
11278534|NCT02787863|OG007|Outcome|Asthma - Prevenar-13/Pneumo-23 (16)|"27 patients with Asthma. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278535|NCT02787863|OG001|Outcome|COPD - Pneumo-23 (11)|23 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278536|NCT02787863|OG000|Outcome|COPD - Prevenar-13 (1)|20 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278537|NCT02787863|OG001|Outcome|COPD - Pneumo-23 (3)|20 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278538|NCT02787863|OG000|Outcome|COPD With Prevenar-13 (1)|"32 patients with COPD. Standard therapy with Prevenar-13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine"
11278539|NCT02787863|OG001|Outcome|Asthma With Prevenar 13 (2)|"33 patients with asthma. Standard therapy with Prevenar 13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine"
11278540|NCT02787863|OG002|Outcome|COPD With Pneumo-23 (3)|"23 patients with COPD. Standard therapy with Pneumo-23.~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278541|NCT02787863|OG003|Outcome|Asthma With Pneumo-23 (4)|"25 patients with asthma. Standard therapy with Pneumo-23.~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278542|NCT02787863|OG004|Outcome|COPD With Pneumo-23/Prevenar-13 (5)|"32 patients with COPD. Standard therapy, vaccinated with PPV23/PCV13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278543|NCT02787863|OG005|Outcome|Asthma With Pneumo-23/Prevenar-13 (6)|"18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278544|NCT02787863|OG006|Outcome|COPD With Prevenar-13/Pneumo-23 (7)|"25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278545|NCT02787863|OG007|Outcome|Asthma With Prevenar-13/Pneumo-23 (8)|"27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.~Prevenar-13: Conjugate 13 serotype pneumococcal vaccine~Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine."
11278546|NCT02787863|OG000|Outcome|COPD - Prevenar-13|32 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278547|NCT02787863|OG001|Outcome|COPD - Pneumo-23|23 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278548|NCT02787863|OG002|Outcome|COPD - Pneumo-23/Prevenar-13|"32 patients with COPD, PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278549|NCT02787863|OG003|Outcome|COPD - Prevenar-13/Pneumo-23|"25 patients with COPD. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11092345|NCT01539291|OG000|Outcome|IDL/Placebo+R to IDL|Participants received IDL 150 mg tablet or placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 (either met or not met the primary endpoint of PD) and may have entered Study GS-US-312-0117 to receive IDL 150 mg or 300 mg tablet twice daily.
11278550|NCT02787863|EG000|Reported Event|COPD - Prevenar-13 (1)|32 patients with COPD. Prevenar-13 (PCV13) vaccination.
11278551|NCT02787863|EG001|Reported Event|Asthma - Prevenar-13 (2)|33 patients with asthma. Prevenar-13 (PCV13) vaccination.
11278552|NCT02787863|EG002|Reported Event|COPD - Pneumo-23 (3)|23 patients with COPD. Pneumo-23 (PPV23) vaccination.
11278553|NCT02787863|EG003|Reported Event|Asthma - Pneumo-23 (4)|25 patients with asthma. Pneumo-23 (PPV23) vaccination.
11278554|NCT02787863|EG004|Reported Event|COPD - Pneumo-23/Prevenar-13 (5)|"32 patients with COPD, PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278555|NCT02787863|EG005|Reported Event|Asthma - Pneumo-23/Prevenar-13 (6)|"18 patients with Asthma. PPV23/PCV13.~PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23."
11278556|NCT02787863|EG006|Reported Event|COPD - Prevenar-13/Pneumo-23 (7)|"25 patients with COPD. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278557|NCT02787863|EG007|Reported Event|Asthma - Prevenar-13/Pneumo-23 (8)|"27 patients with Asthma. PCV13/PPV23 vaccination.~PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13."
11278558|NCT02788019|BG000|Baseline|Mid-Thigh Adductor Block|"Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278559|NCT02788019|BG001|Baseline|Distal-Thigh Adductor Block|"Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278560|NCT02788019|BG002|Baseline|Total|Total of all reporting groups
11278561|NCT02788019|FG000|Participant Flow|Mid-Thigh Adductor Block|"Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278562|NCT02788019|FG001|Participant Flow|Distal-Thigh Adductor Block|"Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278563|NCT02788019|OG000|Outcome|Mid-Thigh Adductor Block|"Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278564|NCT02788019|OG001|Outcome|Distal-Thigh Adductor Block|"Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278565|NCT02788019|EG000|Reported Event|Mid-Thigh Adductor Block|"Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
10822108|NCT00074490|OG000|Outcome|Arm IVD Cohort 1 (Th2 DLI)|Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
11278566|NCT02788019|EG001|Reported Event|Distal-Thigh Adductor Block|"Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).~Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain."
11278567|NCT02788097|BG000|Baseline|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
11278568|NCT02788097|BG001|Baseline|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
11278569|NCT02788097|BG002|Baseline|Total|Total of all reporting groups
11278570|NCT02788097|FG000|Participant Flow|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
11278571|NCT02788097|FG001|Participant Flow|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
11278572|NCT02788097|OG000|Outcome|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
11278573|NCT02788097|OG001|Outcome|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
11278574|NCT02788097|EG000|Reported Event|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
11278575|NCT02788097|EG001|Reported Event|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
11278576|NCT02788175|BG000|Baseline|Vedolizumab in HIV-infected Adults on cART|HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
11278577|NCT02788175|FG000|Participant Flow|Vedolizumab in HIV-infected Adults on cART|HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
11278578|NCT02788175|OG000|Outcome|Vedolizumab in HIV-infected Adults on cART|HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
11278579|NCT02788175|EG000|Reported Event|Vedolizumab in HIV-infected Adults on cART|HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
11278580|NCT02788188|BG000|Baseline|Cohort 1: 1.0mg/kg|SAB-301 1 mg/kg IV single infusion
11278581|NCT02788188|BG001|Baseline|Cohort 2: 2.5mg/kg|SAB-301 2.5 mg/kg IV single infusion
10970520|NCT00910858|OG001|Outcome|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11278582|NCT02788188|BG002|Baseline|Cohort 3: 5mg/kg|SAB-301 5 mg/kg IV single infusion
11278583|NCT02788188|BG003|Baseline|Cohort 4: 10mg/kg|SAB-301 10 mg/kg IV single infusion
11278584|NCT02788188|BG004|Baseline|Cohort 5: 20mg/kg|SAB-301 20 mg/kg IV single infusion
11278585|NCT02788188|BG005|Baseline|Cohort 6: 50mg/kg|SAB-301 50 mg/kg IV single infusion
11278586|NCT02788188|BG006|Baseline|Placebo|Normal Saline IV single infusion
11278587|NCT02788188|BG007|Baseline|Total|Total of all reporting groups
11278588|NCT02788188|FG000|Participant Flow|Cohort 1: 1.0mg/kg|SAB-301 1 mg/kg IV single infusion
11278589|NCT02788188|FG001|Participant Flow|Cohort 2: 2.5mg/kg|SAB-301 2.5 mg/kg IV single infusion
11278590|NCT02788188|FG002|Participant Flow|Cohort 3: 5mg/kg|SAB-301 5 mg/kg IV single infusion
11278591|NCT02788188|FG003|Participant Flow|Cohort 4: 10mg/kg|SAB-301 10 mg/kg IV single infusion
11278592|NCT02788188|FG004|Participant Flow|Cohort 5: 20mg/kg|SAB-301 20 mg/kg IV single infusion
11278593|NCT02788188|FG005|Participant Flow|Cohort 6: 50mg/kg|SAB-301 50 mg/kg IV single infusion
11278594|NCT02788188|FG006|Participant Flow|Placebo|Normal Saline IV single infusion
11278595|NCT02788188|OG000|Outcome|Cohort 1: 1.0mg/kg|SAB-301 1 mg/kg IV single infusion
11278596|NCT02788188|OG001|Outcome|Cohort 2: 2.5mg/kg|SAB-301 2.5 mg/kg IV single infusion
11278597|NCT02788188|OG002|Outcome|Cohort 3: 5mg/kg|SAB-301 5 mg/kg IV single infusion
11278598|NCT02788188|OG003|Outcome|Cohort 4: 10mg/kg|SAB-301 10 mg/kg IV single infusion
10970521|NCT00910858|OG002|Outcome|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11278599|NCT02788188|OG004|Outcome|Cohort 5: 20mg/kg|SAB-301 20 mg/kg IV single infusion
11278600|NCT02788188|OG005|Outcome|Cohort 6: 50mg/kg|SAB-301 50 mg/kg IV single infusion
11278601|NCT02788188|OG006|Outcome|Placebo|Normal Saline IV single infusion
11278602|NCT02788188|EG000|Reported Event|Cohort 1: 1.0mg/kg|SAB-301 1 mg/kg IV single infusion
11278603|NCT02788188|EG001|Reported Event|Cohort 2: 2.5mg/kg|SAB-301 2.5 mg/kg IV single infusion
11278604|NCT02788188|EG002|Reported Event|Cohort 3: 5mg/kg|SAB-301 5 mg/kg IV single infusion
11278605|NCT02788188|EG003|Reported Event|Cohort 4: 10mg/kg|SAB-301 10 mg/kg IV single infusion
11278606|NCT02788188|EG004|Reported Event|Cohort 5: 20mg/kg|SAB-301 20 mg/kg IV single infusion
11278607|NCT02788188|EG005|Reported Event|Cohort 6: 50mg/kg|SAB-301 50 mg/kg IV single infusion
11278608|NCT02788188|EG006|Reported Event|Placebo|Normal Saline IV single infusion
11278609|NCT02788201|BG000|Baseline|Doxorubicin 75mg/m^2|All participants that received Doxorubicin 75mg/m^2.
11278610|NCT02788201|BG001|Baseline|Paclitaxel 100 mg/m^2 and Erlotinib 150 mg|All participants that received Paclitaxel 100 mg/m^2 and Erlotinib 150 mg.
11278611|NCT02788201|BG002|Baseline|Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2|All participants that received Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2.
11278612|NCT02788201|BG003|Baseline|Sunitinib 50mg|All participants that received Sunitinib 50mg.
11278613|NCT02788201|BG004|Baseline|Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2|All participants that received Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.
11278614|NCT02788201|BG005|Baseline|Participants Who Were Enrolled But Not Treated|3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
11278615|NCT02788201|BG006|Baseline|Total|Total of all reporting groups
11278616|NCT02788201|FG000|Participant Flow|Doxorubicin 75mg/m^2|All participants that received Doxorubicin 75mg/m^2.
11278617|NCT02788201|FG001|Participant Flow|Paclitaxel 100 mg/m^2 and Erlotinib 150 mg|All participants that received Paclitaxel 100 mg/m^2 and Erlotinib 150 mg.
11278618|NCT02788201|FG002|Participant Flow|Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2|All participants that received Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2.
11278619|NCT02788201|FG003|Participant Flow|Sunitinib 50mg|All participants that received Sunitinib 50mg.
11278620|NCT02788201|FG004|Participant Flow|Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2|All participants that received Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.
11278621|NCT02788201|FG005|Participant Flow|Participants Who Were Enrolled But Not Treated|3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
11278622|NCT02788201|OG000|Outcome|All COXEN Participants Enrolled|"All participants who were enrolled that signed consent and received Doxorubicin 75mg/m^2, Paclitaxel 100 mg/m^2 and Erlotinib 150 mg, Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.~Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation."
11278623|NCT02788201|OG000|Outcome|All COXEN Participants Receiving Treatment|All participants that received Doxorubicin 75mg/m^2, Paclitaxel 100 mg/m^2 and Erlotinib 150 mg, Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.
11278624|NCT02788201|OG000|Outcome|Doxorubicin 75mg/m^2|All participants that received Doxorubicin 75mg/m^2.
10820386|NCT00057681|EG002|Reported Event|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
10820387|NCT00057746|BG000|Baseline|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
11278625|NCT02788201|OG001|Outcome|Paclitaxel 100 mg/m^2 and Erlotinib 150 mg|All participants that received Paclitaxel 100 mg/m^2 and Erlotinib 150 mg.
11278626|NCT02788201|OG002|Outcome|Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2|All participants that received Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2.
11278627|NCT02788201|OG003|Outcome|Sunitinib 50mg|All participants that received Sunitinib 50mg.
11278628|NCT02788201|OG004|Outcome|Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2|All participants that received Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.
11278629|NCT02788201|OG005|Outcome|Participants Who Were Enrolled But Not Treated|3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
11278630|NCT02788201|EG000|Reported Event|Doxorubicin 75mg/m^2|All participants that received Doxorubicin 75mg/m^2.
11278631|NCT02788201|EG001|Reported Event|Paclitaxel 100 mg/m^2 and Erlotinib 150 mg|All participants that received Paclitaxel 100 mg/m^2 and Erlotinib 150 mg.
11278632|NCT02788201|EG002|Reported Event|Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2|All participants that received Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2.
11278633|NCT02788201|EG003|Reported Event|Sunitinib 50mg|All participants that received Sunitinib 50mg.
11278634|NCT02788201|EG004|Reported Event|Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2|All participants that received Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2.
11278635|NCT02788201|EG005|Reported Event|Participants Who Were Enrolled But Not Treated|3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
11278636|NCT02788279|BG000|Baseline|Regorafenib|Participants received regorafenib 160 milligrams (mg) orally once daily on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278637|NCT02788279|BG001|Baseline|Cobimetinib + Atezolizumab|Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
10820388|NCT00057746|BG001|Baseline|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
11278638|NCT02788279|BG002|Baseline|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278639|NCT02788279|BG003|Baseline|Total|Total of all reporting groups
11278640|NCT02788279|FG000|Participant Flow|Regorafenib|Participants received regorafenib 160 milligrams (mg) orally once daily on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278641|NCT02788279|FG001|Participant Flow|Cobimetinib + Atezolizumab|Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278642|NCT02788279|FG002|Participant Flow|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278643|NCT02788279|OG000|Outcome|Regorafenib|Participants received regorafenib 160 milligrams (mg) orally once daily on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278644|NCT02788279|OG001|Outcome|Cobimetinib + Atezolizumab|Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278645|NCT02788279|OG002|Outcome|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278646|NCT02788279|OG000|Outcome|Cobimetinib + Atezolizumab|Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278647|NCT02788279|OG000|Outcome|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278648|NCT02788279|OG001|Outcome|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278649|NCT02788279|EG000|Reported Event|Regorafenib|Participants received regorafenib 160 milligrams (mg) orally once daily on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278650|NCT02788279|EG001|Reported Event|Cobimetinib + Atezolizumab|Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278651|NCT02788279|EG002|Reported Event|Atezolizumab|Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
11278652|NCT02788357|BG000|Baseline|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278653|NCT02788357|BG001|Baseline|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278654|NCT02788357|BG002|Baseline|Total|Total of all reporting groups
11278655|NCT02788357|FG000|Participant Flow|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278656|NCT02788357|FG001|Participant Flow|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278657|NCT02788357|OG000|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278658|NCT02788357|OG001|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278659|NCT02788357|EG000|Reported Event|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays~Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278660|NCT02788357|EG001|Reported Event|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays~Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
11278661|NCT02788474|BG000|Baseline|Placebo/ Nintedanib|"Participants received soft gelatin capsules of matching placebo for 12 weeks in double blind period and Nintedanib 150 milligram (mg) twice daily (bid) for 40 weeks in open label period.~1 capsule of Nintedanib 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
10820389|NCT00057746|BG002|Baseline|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
10820390|NCT00057746|BG003|Baseline|Total|Total of all reporting groups
10820391|NCT00057746|FG000|Participant Flow|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
10970522|NCT00910858|OG000|Outcome|Responders|Participants with a erythroid response.
11278662|NCT02788474|BG001|Baseline|Nintedanib/ Nintedanib|"Participants received soft gelatin capsules of Nintedanib 150 mg bid for 12 weeks in double blind period and for 40 weeks in open label period.~1 capsule of 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
11278663|NCT02788474|BG002|Baseline|Total|Total of all reporting groups
11278664|NCT02788474|FG000|Participant Flow|Placebo/ Nintedanib|"Participants received soft gelatin capsules of matching placebo for 12 weeks in double blind period and Nintedanib 150 milligram (mg) twice daily (bid) for 40 weeks in open label period.~1 capsule of Nintedanib 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
11278665|NCT02788474|FG001|Participant Flow|Nintedanib/ Nintedanib|"Participants received soft gelatin capsules of Nintedanib 150 mg bid for 12 weeks in double blind period and for 40 weeks in open label period.~1 capsule of 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
11278666|NCT02788474|OG000|Outcome|Placebo/ Nintedanib|"Participants received soft gelatin capsules of matching placebo for 12 weeks in double blind period and Nintedanib 150 milligram (mg) twice daily (bid) for 40 weeks in open label period.~1 capsule of Nintedanib 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
11278667|NCT02788474|OG001|Outcome|Nintedanib/ Nintedanib|"Participants received soft gelatin capsules of Nintedanib 150 mg bid for 12 weeks in double blind period and for 40 weeks in open label period.~1 capsule of 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events (AEs)"
11278668|NCT02788474|EG000|Reported Event|Placebo (Double Blind Period)|Participants received soft gelatin capsules of matching placebo for 12 weeks in double blind period.
11278669|NCT02788474|EG001|Reported Event|Nintedanib (Double Blind Period)|Participants received soft gelatin capsules of Nintedanib 150 mg bid for 12 weeks in double blind period.
11278670|NCT02788474|EG002|Reported Event|Nintedanib (Open Label Period)|Participants received soft gelatin capsules of Nintedanib 150 mg bid for 40 weeks in open label period. 1 capsule of 150 mg bid had possibility to be reduced to 100 mg bid to manage adverse events. Participants initially on placebo in the double blind period also received Nintedanib 150 mg bid in the open label period.
11278671|NCT02788513|BG000|Baseline|2 mg BI 425809|Participants in dose group 1 were orally administered 2 tablets of 1 milligrams (mg) of BI 425809 (Total: 2 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278672|NCT02788513|BG001|Baseline|5 mg BI 425809|Participants in dose group 2 were orally administered 1 tablet of 5 mg of BI 425809 together with 1 tablet of 1 mg / 5 mg and 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278673|NCT02788513|BG002|Baseline|10 mg BI 425809|Participants in dose group 3 were orally administered 2 tablets of 5 mg of BI 425809 (Total: 10 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278674|NCT02788513|BG003|Baseline|25 mg BI 425809|Participants in dose group 4 were orally administered 1 tablet of 25 mg of BI 425809 together with 2 tablets of 1 mg / 5 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278675|NCT02788513|BG004|Baseline|Placebo Group|Participants in the placebo group were orally administered 2 tablets of 1 mg / 5 mg and 1 tablet of 25 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278676|NCT02788513|BG005|Baseline|Total|Total of all reporting groups
11278677|NCT02788513|FG000|Participant Flow|2 mg BI 425809|Participants in dose group 1 were orally administered 2 tablets of 1 milligrams (mg) of BI 425809 (Total: 2 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278678|NCT02788513|FG001|Participant Flow|5 mg BI 425809|Participants in dose group 2 were orally administered 1 tablet of 5 mg of BI 425809 together with 1 tablet of 1 mg / 5 mg and 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11092346|NCT01539291|OG000|Outcome|IDL+R to IDL 150 mg|Participants who received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278679|NCT02788513|FG002|Participant Flow|10 mg BI 425809|Participants in dose group 3 were orally administered 2 tablets of 5 mg of BI 425809 (Total: 10 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
10820392|NCT00057746|FG001|Participant Flow|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
10820393|NCT00057746|FG002|Participant Flow|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
11278680|NCT02788513|FG003|Participant Flow|25 mg BI 425809|Participants in dose group 4 were orally administered 1 tablet of 25 mg of BI 425809 together with 2 tablets of 1 mg / 5 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278681|NCT02788513|FG004|Participant Flow|Placebo Group|Participants in the placebo group were orally administered 2 tablets of 1 mg / 5 mg and 1 tablet of 25 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278682|NCT02788513|OG000|Outcome|2 mg BI 425809|Participants in dose group 1 were orally administered 2 tablets of 1 milligrams (mg) of BI 425809 (Total: 2 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278683|NCT02788513|OG001|Outcome|5 mg BI 425809|Participants in dose group 2 were orally administered 1 tablet of 5 mg of BI 425809 together with 1 tablet of 1 mg / 5 mg and 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278684|NCT02788513|OG002|Outcome|10 mg BI 425809|Participants in dose group 3 were orally administered 2 tablets of 5 mg of BI 425809 (Total: 10 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278685|NCT02788513|OG003|Outcome|25 mg BI 425809|Participants in dose group 4 were orally administered 1 tablet of 25 mg of BI 425809 together with 2 tablets of 1 mg / 5 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
10820394|NCT00057746|OG000|Outcome|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
11278686|NCT02788513|OG004|Outcome|Placebo Group|Participants in the placebo group were orally administered 2 tablets of 1 mg / 5 mg and 1 tablet of 25 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278687|NCT02788513|EG000|Reported Event|2 mg BI 425809|Participants in dose group 1 were orally administered 2 tablets of 1 milligrams (mg) of BI 425809 (Total: 2 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278688|NCT02788513|EG001|Reported Event|5 mg BI 425809|Participants in dose group 2 were orally administered 1 tablet of 5 mg of BI 425809 together with 1 tablet of 1 mg / 5 mg and 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278689|NCT02788513|EG002|Reported Event|10 mg BI 425809|Participants in dose group 3 were orally administered 2 tablets of 5 mg of BI 425809 (Total: 10 mg) together with 1 tablet of 25 mg placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278690|NCT02788513|EG003|Reported Event|25 mg BI 425809|Participants in dose group 4 were orally administered 1 tablet of 25 mg of BI 425809 together with 2 tablets of 1 mg / 5 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278691|NCT02788513|EG004|Reported Event|Placebo Group|Participants in the placebo group were orally administered 2 tablets of 1 mg / 5 mg and 1 tablet of 25 mg of placebo match once daily (qd) during 12 weeks. The tablets were to be taken with water in the morning at approximately the same time every day with or without food.
11278692|NCT02788656|BG000|Baseline|Group A|Entresto + Placebo
11278693|NCT02788656|BG001|Baseline|Group B|ACE/ARB + Placebo
11278694|NCT02788656|BG002|Baseline|Total|Total of all reporting groups
11278695|NCT02788656|FG000|Participant Flow|Group A|Group A will receive sacubitril/valsartan + placebo for weeks 1-12. and then sacubitril/valsartan only for weeks 13-32. All subjects in Group A will also receive longitudinal pulmonary artery pressure monitoring using a previously placed implantable hemodynamic monitor (CardioMEMS device).
11278696|NCT02788656|FG001|Participant Flow|Group B|"Group B will receive an Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin II Type 1 Receptor Blocker (ARB) + placebo for weeks 1-6 (depending on previous background therapy) and then switch to sacubitril/valsartan + placebo for weeks 7-12.~Group B will then receive sacubitril/valsartan only for weeks 13-32. All subjects in Group B will also receive longitudinal pulmonary artery pressure monitoring using a previously placed implantable hemodynamic monitor (CardioMEMS device)."
11278697|NCT02788656|OG000|Outcome|Group A|Entresto + Placebo
11278698|NCT02788656|OG001|Outcome|Group B|ACE/ARB + Placebo
11278699|NCT02788656|EG000|Reported Event|Group A|Entresto + Placebo
11278700|NCT02788656|EG001|Reported Event|Group B|ACE/ARB + Placebo
11278701|NCT02788747|BG000|Baseline|4 mg Elamipretide|Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
11278702|NCT02788747|BG001|Baseline|40 mg Elamipretide|Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
11278703|NCT02788747|BG002|Baseline|Placebo|Subcutaneous injection of placebo administered once daily for 28 consecutive days
11278704|NCT02788747|BG003|Baseline|Total|Total of all reporting groups
10820395|NCT00057746|OG001|Outcome|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
11278705|NCT02788747|FG000|Participant Flow|4 mg Elamipretide|Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
11278706|NCT02788747|FG001|Participant Flow|40 mg Elamipretide|Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
11278707|NCT02788747|FG002|Participant Flow|Placebo|Subcutaneous injection of placebo administered once daily for 28 consecutive days
11278708|NCT02788747|OG000|Outcome|4 mg Elamipretide|4 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days
11278709|NCT02788747|OG001|Outcome|40 mg Elamipretide|40 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days
11278710|NCT02788747|OG002|Outcome|Placebo|Placebo: subcutaneous injection of placebo administered once daily for 28 consecutive days
11278711|NCT02788747|OG000|Outcome|4 mg Elamipretide|Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
11278712|NCT02788747|OG001|Outcome|40 mg Elamipretide|Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
11278713|NCT02788747|OG002|Outcome|Placebo|Subcutaneous injection of placebo administered once daily for 28 consecutive days
11278714|NCT02788747|EG000|Reported Event|4 mg Elamipretide|4 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days
11278715|NCT02788747|EG001|Reported Event|40 mg Elamipretide|40 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days
10820396|NCT00057746|OG002|Outcome|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
11278716|NCT02788747|EG002|Reported Event|Placebo|Placebo: subcutaneous injection of placebo administered once daily for 28 consecutive days
11278717|NCT02788903|BG000|Baseline|Diabetes|"During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.~Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes"
11278718|NCT02788903|BG001|Baseline|Pre-Diabetes|"The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes."
11278719|NCT02788903|BG002|Baseline|Total|Total of all reporting groups
11278720|NCT02788903|FG000|Participant Flow|Diabetes|"During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.~Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes"
11278721|NCT02788903|FG001|Participant Flow|Pre-Diabetes|"The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes."
11287031|NCT02896400|OG007|Outcome|Text CONTROL|"All 8 arms which did not include the Text intervention:~BNI+NRT+QL BNI+NRT BNI+QL BNI Only NRT+QL NRT Only QL Only Control"
11278722|NCT02788903|OG000|Outcome|Diabetes|"During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.~Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes"
11278723|NCT02788903|OG001|Outcome|Pre-Diabetes|"The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes."
11278724|NCT02788903|OG000|Outcome|Diabetes|"During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes."
11278725|NCT02788903|EG000|Reported Event|Diabetes|"During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.~Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes"
11278726|NCT02788903|EG001|Reported Event|Pre-Diabetes|"The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.~Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes."
11278727|NCT02788903|EG002|Reported Event|COVID-19|"This cohort of patients will be defined as patients age 18 and older who have received a diagnosis of COVID-19.~Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes"
11278728|NCT02789033|BG000|Baseline|Active Comparator: Chitosan|"Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine~And~Placebo in the same pharmacological presentation that Isosorbide dinitrate spray"
11278729|NCT02789033|BG001|Baseline|Active Comparator: Isosorbide Dinitrate Spray|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Placebo in the same pharmacological presentation that Chitosan"
11278730|NCT02789033|BG002|Baseline|Combination: IDS and Chitosan|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine"
11278731|NCT02789033|BG003|Baseline|Placebo Comparator: Placebo|Placebo in the same pharmacological presentation that both, IDS and Chitosan.
11278732|NCT02789033|BG004|Baseline|Total|Total of all reporting groups
11278733|NCT02789033|FG000|Participant Flow|Active Comparator: Chitosan|"Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine~And~Placebo in the same pharmacological presentation that Isosorbide dinitrate spray"
11278734|NCT02789033|FG001|Participant Flow|Active Comparator: Isosorbide Dinitrate Spray|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Placebo in the same pharmacological presentation that Chitosan"
11278735|NCT02789033|FG002|Participant Flow|Combination: IDS and Chitosan|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine"
11278736|NCT02789033|FG003|Participant Flow|Placebo Comparator: Placebo|Placebo in the same pharmacological presentation that both, IDS and Chitosan.
11278737|NCT02789033|OG000|Outcome|Active Comparator: Chitosan|"Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine~And~Placebo in the same pharmacological presentation that Isosorbide dinitrate spray"
10820397|NCT00057746|EG000|Reported Event|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
10970523|NCT00910858|OG001|Outcome|Non-responders|Participants who were not erythroid responders.
11278738|NCT02789033|OG001|Outcome|Active Comparator: Isosorbide Dinitrate Spray|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Placebo in the same pharmacological presentation that Chitosan"
11278739|NCT02789033|OG002|Outcome|Combination: IDS and Chitosan|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine"
11278740|NCT02789033|OG003|Outcome|Placebo Comparator: Placebo|Placebo in the same pharmacological presentation that both, IDS and Chitosan.
11278741|NCT02789033|EG000|Reported Event|Active Comparator: Chitosan|"Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine~And~Placebo in the same pharmacological presentation that Isosorbide dinitrate spray"
11278742|NCT02789033|EG001|Reported Event|Active Comparator: Isosorbide Dinitrate Spray|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Placebo in the same pharmacological presentation that Chitosan"
11278743|NCT02789033|EG002|Reported Event|Combination: IDS and Chitosan|"Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.~And~Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine"
11278744|NCT02789033|EG003|Reported Event|Placebo Comparator: Placebo|Placebo in the same pharmacological presentation that both, IDS and Chitosan.
11278745|NCT02789111|BG000|Baseline|Alvimopan|"12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Alvimopan: Alviimopan 12 mg twice daily up to 15 doses"
11278746|NCT02789111|BG001|Baseline|Placebo|"Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Placebo: Placebo twice daily up to 15 doses"
10820398|NCT00057746|EG001|Reported Event|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
11278747|NCT02789111|BG002|Baseline|Total|Total of all reporting groups
11278748|NCT02789111|FG000|Participant Flow|Alvimopan|"12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Alvimopan: Alviimopan 12 mg twice daily up to 15 doses"
11278749|NCT02789111|FG001|Participant Flow|Placebo|"Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Placebo: Placebo twice daily up to 15 doses"
11278750|NCT02789111|OG000|Outcome|Alvimopan|"12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Alvimopan: Alviimopan 12 mg twice daily up to 15 doses"
11278751|NCT02789111|OG001|Outcome|Placebo|"Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Placebo: Placebo twice daily up to 15 doses"
11278752|NCT02789111|OG000|Outcome|Placebo|Placebo group
11278753|NCT02789111|OG001|Outcome|Alvimopan|Alvimopan group
11278754|NCT02789111|EG000|Reported Event|Alvimopan|"12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Alvimopan: Alviimopan 12 mg twice daily up to 15 doses"
11278755|NCT02789111|EG001|Reported Event|Placebo|"Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.~Placebo: Placebo twice daily up to 15 doses"
11278756|NCT02789137|BG000|Baseline|Tyrosine Kinase Inhibitor|Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
11278757|NCT02789137|FG000|Participant Flow|Tyrosine Kinase Inhibitor|Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
11278758|NCT02789137|OG000|Outcome|Tyrosine Kinase Inhibitor|Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
11278759|NCT02789137|EG000|Reported Event|Sunitinib|"Participants diagnosed with mRCC who received either 4/2 regimen or 2/1 regimen of 50 mg or 37.5 mg or 25 mg dose of Sunitinib as first line treatment, prescribed by physician, in real world practice were observed in this study. 2/1 regimen meant 14 days on drug and 7 days without drug. 4/2 regimen meant 28 days on drug and 14 days without drug."
11278760|NCT02789137|EG001|Reported Event|Pazopanib|Participants diagnosed with mRCC who received 800 mg of Pazopanib per 24 hours continuously as first line treatment, prescribed by physician, in real world practice were observed in this study.
11278761|NCT02789176|BG000|Baseline|Outpatient Enrollees - Maintatin Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
10820399|NCT00057746|EG002|Reported Event|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
10970524|NCT00910858|OG002|Outcome|Overall|All participants in the Safety population.
11278762|NCT02789176|BG001|Baseline|Outpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278763|NCT02789176|BG002|Baseline|Inpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278764|NCT02789176|BG003|Baseline|Inpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278765|NCT02789176|BG004|Baseline|Total|Total of all reporting groups
11278766|NCT02789176|FG000|Participant Flow|Outpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278767|NCT02789176|FG001|Participant Flow|Outpatient Enrollees- Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278768|NCT02789176|FG002|Participant Flow|Inpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278769|NCT02789176|FG003|Participant Flow|Inpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278770|NCT02789176|OG000|Outcome|Outpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278771|NCT02789176|OG001|Outcome|Outpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278772|NCT02789176|OG002|Outcome|Inpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278773|NCT02789176|OG003|Outcome|Inpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278774|NCT02789176|EG000|Reported Event|Outpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) on anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278775|NCT02789176|EG001|Reported Event|Outpatient Enrollees - Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were previously enrolled in the Neonatal Seizure Registry and had been discharged from the Neonatal Intensive Care Unit (NICU) off anti-seizure medicine. They were asked to take part in all prospective follow up surveys regarding development, epilepsy, and family impact at 12, 18, & 24 months of age.
11278776|NCT02789176|EG002|Reported Event|Inpatient Enrollees - Maintain Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged on anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278777|NCT02789176|EG003|Reported Event|Inpatient Enrollees -Discontinue Anti-Seizure Medicine|This is a cohort of subjects who were enrolled in the study prior to discharge from the NICU and had been discharged off anti-seizure medicine. They were asked to return to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, and complete surveys regarding development, epilepsy, and family impact prior to discharge from the NICU and at 12, 18, & 24 months of age.
11278778|NCT02789410|BG000|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.~Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief."
11278779|NCT02789410|BG001|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.~Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief."
11278780|NCT02789410|BG002|Baseline|Total|Total of all reporting groups
11278781|NCT02789410|FG000|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.~Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief."
11278782|NCT02789410|FG001|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.~Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief."
11278783|NCT02789410|OG000|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.~Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief."
11278784|NCT02789410|OG001|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.~Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief."
11278785|NCT02789410|EG000|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.~Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief."
11278786|NCT02789410|EG001|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.~Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief."
11278787|NCT02790073|BG000|Baseline|SNF472|SNF472 for calciphylaxis
11278788|NCT02790073|FG000|Participant Flow|SNF472|SNF472 for Calciphylaxis
11278789|NCT02790073|OG000|Outcome|SNF472|SNF472 for calciphylaxis
11278790|NCT02790073|EG000|Reported Event|SNF472|SNF472 for Calciphylaxis
11278791|NCT02790281|BG000|Baseline|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) >5 mg/L.
11278792|NCT02790281|FG000|Participant Flow|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) >5 mg/L.
11278793|NCT02790281|OG000|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) >5 mg/L.
11278794|NCT02790281|EG000|Reported Event|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) >5 mg/L.
11278795|NCT02790437|BG000|Baseline|One Dose of IdeS (0.25 mg/kg BW)|"IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment"
11278796|NCT02790437|BG001|Baseline|Two Doses of IdeS (2 x 0.25 mg/kg BW)|"Two (2) IdeS intravenous infusions~IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment"
11278797|NCT02790437|BG002|Baseline|Total|Total of all reporting groups
11278798|NCT02790437|FG000|Participant Flow|One Dose of IdeS (0.25 mg/kg BW)|"One (1) IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment"
11278799|NCT02790437|FG001|Participant Flow|Two Doses of IdeS (2 x 0.25 mg/kg BW)|"Two (2) IdeS intravenous infusions~IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment"
11278800|NCT02790437|OG000|Outcome|FAS - One or Two Doses of 0.25 mg/kg BW IdeS|"IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment~Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data."
11278801|NCT02790437|OG000|Outcome|PP - One or Two Doses of 0.25 mg/kg BW IdeS|"IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment~The per protocol (PP) set consists of all patients in the safety analysis set (SAS) who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278802|NCT02790437|OG000|Outcome|PP - One Dose of 0.25 mg/kg BW IdeS|"One (1) IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment~Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278803|NCT02790437|OG001|Outcome|PP - Two Doses of 0.25 mg/kg BW IdeS|"Two (2) IdeS intravenous infusion~IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment~Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278804|NCT02790437|OG002|Outcome|PP - One or Two Doses of 0.25 mg/kg BW IdeS|"IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment~The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278805|NCT02790437|OG000|Outcome|PP - One or Two Doses of 0.25 mg/kg BW IdeS|"IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment~Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278806|NCT02790437|OG000|Outcome|PP - Two Doses of 0.25 mg/kg BW IdeS|"Two (2) IdeS intravenous infusion~IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment~Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278807|NCT02790437|OG001|Outcome|PP - Two Doses of 0.25 mg/kg BW IdeS|"Two (2) IdeS intravenous infusions~IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment.~Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded."
11278808|NCT02790437|EG000|Reported Event|SAS - One Dose of IdeS (0.25 mg/kg BW)|"One (1) IdeS intravenous infusion~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0.~Kidney transplantation: Performed following IdeS treatment~The SAS consists of all patients dosed with any amount of IdeS."
11278809|NCT02790437|EG001|Reported Event|SAS - Two Doses of IdeS (2 x 0.25 mg/kg BW)|"Two (2) IdeS intravenous infusions~IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment.~The SAS consists of all patients dosed with any amount of IdeS."
11278810|NCT02790437|EG002|Reported Event|SAS - All Patients (One or Two Doses of IdeS (0.25 mg/kg BW))|"One (1) or two (2) IdeS intravenous infusions.~IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.~Kidney transplantation: Performed following IdeS treatment.~The SAS consists of all patients dosed with any amount of IdeS."
11278811|NCT02790463|BG000|Baseline|Usual Care|Participants recruited in this arm will receive their usual care for gout as they normally would
11278812|NCT02790463|BG001|Baseline|Intervention|"Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention~Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact"
11278813|NCT02790463|BG002|Baseline|Total|Total of all reporting groups
11278814|NCT02790463|FG000|Participant Flow|Usual Care|Participants recruited in this arm will receive their usual care for gout as they normally would
11278815|NCT02790463|FG001|Participant Flow|Intervention|"Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention~Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact"
11278816|NCT02790463|OG000|Outcome|Usual Care|Participants recruited in this arm will receive their usual care for gout as they normally would
11278817|NCT02790463|OG001|Outcome|Intervention|"Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention~Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact"
11278818|NCT02790463|EG000|Reported Event|Usual Care|Participants recruited in this arm will receive their usual care for gout as they normally would
11278819|NCT02790463|EG001|Reported Event|Intervention|"Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention~Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact"
11278820|NCT02790606|BG000|Baseline|Covera(TM) Vascular Covered Stent|Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
11278821|NCT02790606|FG000|Participant Flow|Covera(TM) Vascular Covered Stent|Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
11278822|NCT02790606|OG000|Outcome|Covera(TM) Vascular Covered Stent|Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
11278823|NCT02790606|EG000|Reported Event|Covera(TM) Vascular Covered Stent|Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
11278824|NCT02790736|BG000|Baseline|Propranolol|"Propranolol 40 mg capsule, given once after fear activation procedure~propranolol: active treatment"
11278825|NCT02790736|BG001|Baseline|Placebo Capsule|"Placebo capsule, given once after fear activation procedure~Placebo: inactive pill"
11278826|NCT02790736|BG002|Baseline|Total|Total of all reporting groups
11278827|NCT02790736|FG000|Participant Flow|Propranolol|"Propranolol 40 mg capsule, given once after fear activation procedure~propranolol: active treatment"
11278828|NCT02790736|FG001|Participant Flow|Placebo Capsule|"Placebo capsule, given once after fear activation procedure~Placebo: inactive pill"
11278829|NCT02790736|OG000|Outcome|Propranolol|"Propranolol 40 mg capsule, given once after fear activation procedure~propranolol: active treatment"
10820400|NCT00057785|BG000|Baseline|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
11278830|NCT02790736|OG001|Outcome|Placebo Capsule|"Placebo capsule, given once after fear activation procedure~Placebo: inactive pill"
11278831|NCT02790736|EG000|Reported Event|Propranolol|"Propranolol 40 mg capsule, given once after fear activation procedure~propranolol: active treatment"
11278832|NCT02790736|EG001|Reported Event|Placebo Capsule|"Placebo capsule, given once after fear activation procedure~Placebo: inactive pill"
11278833|NCT02790788|BG000|Baseline|Steroids Group|"Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days.~Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock~Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278834|NCT02790788|BG001|Baseline|Control Group|"Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm).~Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.~Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278835|NCT02790788|BG002|Baseline|Total|Total of all reporting groups
11278836|NCT02790788|FG000|Participant Flow|Steroids Group|"Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days.~Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock~Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278837|NCT02790788|FG001|Participant Flow|Control Group|"Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm).~Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.~Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278838|NCT02790788|OG000|Outcome|Steroids Group|"Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days.~Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock"
11278839|NCT02790788|OG001|Outcome|Control Group|"Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm).~Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase."
11278840|NCT02790788|OG000|Outcome|Steroids Group|"Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days.~Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock~Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11287032|NCT02896400|EG000|Reported Event|NRT+QL+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11092347|NCT01539291|OG001|Outcome|IDL+R (PD) to IDL 300 mg|Participants received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily.
11278841|NCT02790788|OG001|Outcome|Control Group|"Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm).~Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.~Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278842|NCT02790788|EG000|Reported Event|Steroids Group|"Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days.~Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock~Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278843|NCT02790788|EG001|Reported Event|Control Group|"Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm).~Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.~Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock."
11278844|NCT02791191|BG000|Baseline|3 mg LY3202626|3 mg LY3202626 administered orally once daily for 52 weeks.
11278845|NCT02791191|BG001|Baseline|12 mg LY3202626|12 mg LY3202626 administered orally once daily for 52 weeks.
11278846|NCT02791191|BG002|Baseline|Placebo|Placebo administered orally once daily for 52 weeks.
11278847|NCT02791191|BG003|Baseline|Total|Total of all reporting groups
11278848|NCT02791191|FG000|Participant Flow|3 mg LY3202626|3 mg LY3202626 administered orally once daily for 52 weeks.
11278849|NCT02791191|FG001|Participant Flow|12 mg LY3202626|12 mg LY3202626 administered orally once daily for 52 weeks.
11278850|NCT02791191|FG002|Participant Flow|Placebo|Placebo administered orally once daily for 52 weeks.
11278851|NCT02791191|OG000|Outcome|3 mg LY3202626|3 mg LY3202626 administered orally once daily for 52 weeks.
11278852|NCT02791191|OG001|Outcome|12 mg LY3202626|12 mg LY3202626 administered orally once daily for 52 weeks.
11278853|NCT02791191|OG002|Outcome|Placebo|Placebo administered orally once daily for 52 weeks.
11278854|NCT02791191|EG000|Reported Event|3 mg LY3202626|3 mg LY3202626 administered orally once daily for 52 weeks.
11278855|NCT02791191|EG001|Reported Event|12 mg LY3202626|12 mg LY3202626 administered orally once daily for 52 weeks
11278856|NCT02791191|EG002|Reported Event|Placebo|Placebo administered orally once daily for 52 weeks.
11278857|NCT02791269|BG000|Baseline|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278858|NCT02791269|BG001|Baseline|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278859|NCT02791269|BG002|Baseline|Total|Total of all reporting groups
11278860|NCT02791269|FG000|Participant Flow|HBeAg Negative Participants|Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278861|NCT02791269|FG001|Participant Flow|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278862|NCT02791269|OG000|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278863|NCT02791269|OG000|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
11278864|NCT02791269|OG001|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278865|NCT02791269|OG000|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278866|NCT02791269|EG000|Reported Event|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278867|NCT02791269|EG001|Reported Event|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
11278868|NCT02791308|BG000|Baseline|Pimecrolimus Cream, 1%|"Pimecrolimus Cream, 1% (Actavis)~Pimecrolimus Cream, 1%"
11278869|NCT02791308|BG001|Baseline|Elidel Cream, 1%|"Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)~Pimecrolimus Cream 1% (Valeant)"
11278870|NCT02791308|BG002|Baseline|Vehicle Cream|"Cream vehicle of the test product (Actavis)~Vehicle cream"
11278871|NCT02791308|BG003|Baseline|Total|Total of all reporting groups
11278872|NCT02791308|FG000|Participant Flow|Pimecrolimus Cream, 1%|"Pimecrolimus Cream, 1% (Actavis)~Pimecrolimus Cream, 1%"
11278873|NCT02791308|FG001|Participant Flow|Elidel Cream, 1%|"Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)~Pimecrolimus Cream 1% (Valeant)"
11278874|NCT02791308|FG002|Participant Flow|Vehicle Cream|"Cream vehicle of the test product (Actavis)~Vehicle cream"
11278875|NCT02791308|OG000|Outcome|Pimecrolimus Cream, 1%|"Pimecrolimus Cream, 1% (Actavis)~Pimecrolimus Cream, 1%"
11278876|NCT02791308|OG001|Outcome|Elidel Cream, 1%|"Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)~Pimecrolimus Cream 1% (Valeant)"
11278877|NCT02791308|OG002|Outcome|Vehicle Cream|"Cream vehicle of the test product (Actavis)~Vehicle cream"
11278878|NCT02791308|EG000|Reported Event|Pimecrolimus Cream, 1%|"Pimecrolimus Cream, 1% (Actavis)~Pimecrolimus Cream, 1%"
11278879|NCT02791308|EG001|Reported Event|Elidel Cream, 1%|"Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)~Pimecrolimus Cream 1% (Valeant)"
11278880|NCT02791308|EG002|Reported Event|Vehicle Cream|"Cream vehicle of the test product (Actavis)~Vehicle cream"
11287033|NCT02896400|EG001|Reported Event|BNI+QL+Text|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287034|NCT02896400|EG002|Reported Event|BNI+NRT+QL+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287035|NCT02896400|EG003|Reported Event|NRT+QL|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287036|NCT02896400|EG004|Reported Event|BNI+QL|"Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287037|NCT02896400|EG005|Reported Event|NRT Only|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11287038|NCT02896400|EG006|Reported Event|BNI+Text|"Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287039|NCT02896400|EG007|Reported Event|BNI+NRT+Text|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11092348|NCT01539291|OG002|Outcome|Placebo+R (PD) to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11287040|NCT02896400|EG008|Reported Event|NRT+Text|"Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287041|NCT02896400|EG009|Reported Event|BNI+NRT|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece."
11287042|NCT02896400|EG010|Reported Event|Control|Control arm, no intervention
11287043|NCT02896400|EG011|Reported Event|BNI+NRT+QL|"Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior~Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11287044|NCT02896400|EG012|Reported Event|Text Only|"Registration in SmokefreeText (Text)~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287045|NCT02896400|EG013|Reported Event|QL+Text|"Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.~SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study."
11287046|NCT02896400|EG014|Reported Event|BNI Only|"Brief Negotiated Interview (BNI)~Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior"
11287047|NCT02896400|EG015|Reported Event|QL Only|"Referral to CT Smokers Quitline (QL)~CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling."
11278881|NCT02791399|BG000|Baseline|Control|Treatment as usual
11278882|NCT02791399|BG001|Baseline|ISOP Intervention|"Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.~ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse."
11278883|NCT02791399|BG002|Baseline|Total|Total of all reporting groups
11278884|NCT02791399|FG000|Participant Flow|Control|Treatment as usual
11278885|NCT02791399|FG001|Participant Flow|ISOP Intervention|"Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.~ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse."
11278886|NCT02791399|OG000|Outcome|Control|Treatment as usual
11278887|NCT02791399|OG001|Outcome|ISOP Intervention|"Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.~ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse."
11278888|NCT02791399|EG000|Reported Event|Control|Treatment as usual
11278889|NCT02791399|EG001|Reported Event|ISOP Intervention|"Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.~ISOP Intervention with the Nurse Care Manager: A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse."
11278890|NCT02791438|BG000|Baseline|Azilsartan 2.5 - 20 mg (Weight < 50 kg)|Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg.
11278891|NCT02791438|BG001|Baseline|Azilsartan 5 - 40 mg (Weight ≥ 50 kg)|Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
11278892|NCT02791438|BG002|Baseline|Total|Total of all reporting groups
11278893|NCT02791438|FG000|Participant Flow|Azilsartan 2.5 - 20 mg (Weight < 50 kg)|Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg.
11278894|NCT02791438|FG001|Participant Flow|Azilsartan 5 - 40 mg (Weight ≥ 50 kg)|Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
11278895|NCT02791438|OG000|Outcome|Azilsartan 2.5 - 20 mg (Weight < 50 kg)|Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg.
11278896|NCT02791438|OG001|Outcome|Azilsartan 5 - 40 mg (Weight ≥ 50 kg)|Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
11278897|NCT02791438|EG000|Reported Event|Azilsartan 2.5 - 20 mg (Weight < 50 kg)|Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg.
11278898|NCT02791438|EG001|Reported Event|Azilsartan 5 - 40 mg (Weight ≥ 50 kg)|Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
11278899|NCT02791490|BG000|Baseline|Sitagliptin|Participants received sitagliptin 100 mg once daily for 20 weeks. They also received Met-IR, which was titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278900|NCT02791490|BG001|Baseline|Placebo|Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278901|NCT02791490|BG002|Baseline|Total|Total of all reporting groups
11278902|NCT02791490|FG000|Participant Flow|Sitagliptin|Participants received sitagliptin 100 mg once daily for 20 weeks. They also received immediate-release metformin (Met-IR), which was titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278903|NCT02791490|FG001|Participant Flow|Placebo|Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278904|NCT02791490|OG000|Outcome|Sitagliptin|Participants received sitagliptin 100 mg once daily for 20 weeks. They also received Met-IR, which was titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278905|NCT02791490|OG001|Outcome|Placebo|Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278906|NCT02791490|EG000|Reported Event|Sitagliptin|Participants received sitagliptin 100 mg once daily for 20 weeks. They also received Met-IR, which was titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278907|NCT02791490|EG001|Reported Event|Placebo|Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
11278908|NCT02791516|BG000|Baseline|Placebo|Participants received placebo subcutaneous injection once a month for 6 months.
11278909|NCT02791516|BG001|Baseline|Romosozumab 210 mg|Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
11278910|NCT02791516|BG002|Baseline|Total|Total of all reporting groups
11278911|NCT02791516|FG000|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a month for 6 months.
11278912|NCT02791516|FG001|Participant Flow|Romosozumab 210 mg|Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
11278913|NCT02791516|OG000|Outcome|Placebo|Participants received placebo subcutaneous injection once a month for 6 months.
11278914|NCT02791516|OG001|Outcome|Romosozumab 210 mg|Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
11278915|NCT02791516|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injection once a month for 6 months.
11278916|NCT02791516|EG001|Reported Event|Romosozumab 210 mg|Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
11278917|NCT02791659|BG000|Baseline|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278918|NCT02791659|BG001|Baseline|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278919|NCT02791659|BG002|Baseline|Total|Total of all reporting groups
11278920|NCT02791659|FG000|Participant Flow|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278921|NCT02791659|FG001|Participant Flow|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278922|NCT02791659|OG000|Outcome|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278923|NCT02791659|OG001|Outcome|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278924|NCT02791659|EG000|Reported Event|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278925|NCT02791659|EG001|Reported Event|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
11278926|NCT02791763|BG000|Baseline|Daprodustat in ND Participants|Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks.
11278927|NCT02791763|BG001|Baseline|Epoetin Beta Pegol in ND Participants|Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
11278928|NCT02791763|BG002|Baseline|Daprodustat in PD Participants|Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
11278929|NCT02791763|BG003|Baseline|Total|Total of all reporting groups
11278930|NCT02791763|FG000|Participant Flow|Daprodustat in ND Participants|Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks.
11278931|NCT02791763|FG001|Participant Flow|Epoetin Beta Pegol in ND Participants|Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
11278932|NCT02791763|FG002|Participant Flow|Daprodustat in PD Participants|Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
11278933|NCT02791763|OG000|Outcome|Daprodustat in ND Participants|Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks.
11278934|NCT02791763|OG001|Outcome|Epoetin Beta Pegol in ND Participants|Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
11278935|NCT02791763|OG000|Outcome|Daprodustat in PD Participants|Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
11278936|NCT02791763|OG000|Outcome|Epoetin Beta Pegol in ND Participants|Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
11278937|NCT02791763|OG000|Outcome|Daprodustat 1 mg|Participants received oral daprodustat tablet (1 mg) once on the day of PK sampling at Week 12 or 24.
11278938|NCT02791763|OG001|Outcome|Daprodustat 2 mg|Participants received oral daprodustat tablet (2 mg) once on the day of PK sampling at Week 12 or 24.
11092349|NCT01539291|OG003|Outcome|Placebo+R to IDL 150 mg|Participants received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278939|NCT02791763|OG002|Outcome|Daprodustat 4 mg|Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
11278940|NCT02791763|OG003|Outcome|Daprodustat 6 mg|Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
11278941|NCT02791763|OG004|Outcome|Daprodustat 8 mg|Participants received oral dose of 8 mg daprodustat (4 mg*2 tablets) once on the day of PK sampling at Week 12 or 24.
11278942|NCT02791763|OG005|Outcome|Daprodustat 12 mg|Participants received oral dose of 12 mg of daprodustat (6 mg*2 tablets) once on the day of PK sampling at Week 12 or 24.
11278943|NCT02791763|OG006|Outcome|Daprodustat 18 mg|Participants received oral dose of 18 mg of daprodustat (6 mg*3 tablets) once on the day of PK sampling at Week 12 or 24.
11278944|NCT02791763|OG007|Outcome|Daprodustat 24 mg|Participants received oral dose of 24 mg of daprodustat (6 mg*4 tablets) once on the day of PK sampling at Week 12 or 24.
11278945|NCT02791763|EG000|Reported Event|Daprodustat in ND Participants|Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks.
11278946|NCT02791763|EG001|Reported Event|Epoetin Beta Pegol in ND Participants|Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
11278947|NCT02791763|EG002|Reported Event|Daprodustat in PD Participants|Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
11278948|NCT02791893|BG000|Baseline|VNS Device|"Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day~VNS device: Hand held device to use for self administration of vagus nerve stimulation."
11278949|NCT02791893|BG001|Baseline|Inactive Device|"Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.~VNS device: Hand held device to use for self administration of vagus nerve stimulation.~Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation."
11278950|NCT02791893|BG002|Baseline|Total|Total of all reporting groups
11278951|NCT02791893|FG000|Participant Flow|VNS Device|"Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day~VNS device: Hand held device to use for self administration of vagus nerve stimulation."
11287048|NCT02896569|BG000|Baseline|Topical Combination Therapy|"Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face~Topical combination therapy"
11278952|NCT02791893|FG001|Participant Flow|Inactive Device|"Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.~VNS device: Hand held device to use for self administration of vagus nerve stimulation.~Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation."
11278953|NCT02791893|OG000|Outcome|VNS Device|"Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day~VNS device: Hand held device to use for self administration of vagus nerve stimulation."
11278954|NCT02791893|OG001|Outcome|Inactive Device|"Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.~VNS device: Hand held device to use for self administration of vagus nerve stimulation.~Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation."
11278955|NCT02791893|EG000|Reported Event|VNS Device|"Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day~VNS device: Hand held device to use for self administration of vagus nerve stimulation."
11278956|NCT02791893|EG001|Reported Event|Inactive Device|"Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.~VNS device: Hand held device to use for self administration of vagus nerve stimulation.~Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation."
11278957|NCT02791906|BG000|Baseline|ISMN Only|"Patients receive only ISMN~ISMN"
11278958|NCT02791906|BG001|Baseline|ISMN AND Vitamin C|"Patients receive both ISMN and Vitamin C~ISMN~Vitamin C"
11278959|NCT02791906|BG002|Baseline|Total|Total of all reporting groups
11278960|NCT02791906|FG000|Participant Flow|ISMN Only|"Patients receive only ISMN~ISMN"
11278961|NCT02791906|FG001|Participant Flow|ISMN AND Vitamin C|"Patients receive both ISMN and Vitamin C~ISMN~Vitamin C"
11278962|NCT02791906|OG000|Outcome|ISMN Only|"Patients receive only ISMN~ISMN"
11278963|NCT02791906|OG001|Outcome|ISMN AND Vitamin C|"Patients receive both ISMN and Vitamin C~ISMN~Vitamin C"
11278964|NCT02791906|OG000|Outcome|ISMN Only|Monotherapy with isosorbide mononitrate
11278965|NCT02791906|OG001|Outcome|ISMN AND Vitamin C|Combination therapy with isosorbide mononitrate and vitamin C
11278966|NCT02791906|EG000|Reported Event|ISMN Only|Monotherapy with isosorbide mononitrate
11278967|NCT02791906|EG001|Reported Event|ISMN AND Vitamin C|Combination therapy with isosorbide mononitrate and vitamin C
11278968|NCT02791945|BG000|Baseline|N-acetylcysteine|"N-acetylcysteine capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~N-acetylcysteine: Experimental supplement"
11278969|NCT02791945|BG001|Baseline|Placebo|"Placebo capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~Placebo: Placebo comparator"
11278970|NCT02791945|BG002|Baseline|Total|Total of all reporting groups
11278971|NCT02791945|FG000|Participant Flow|N-acetylcysteine|"N-acetylcysteine capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~N-acetylcysteine: Experimental supplement"
11092350|NCT01539291|EG000|Reported Event|IDL+R to IDL 150 mg|Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11278972|NCT02791945|FG001|Participant Flow|Placebo|"Placebo capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~Placebo: Placebo comparator"
11278973|NCT02791945|OG000|Outcome|N-acetylcysteine|"N-acetylcysteine capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~N-acetylcysteine: Experimental supplement"
11278974|NCT02791945|OG001|Outcome|Placebo|"Placebo capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~Placebo: Placebo comparator"
11278975|NCT02791945|EG000|Reported Event|N-acetylcysteine|"N-acetylcysteine capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~N-acetylcysteine: Experimental supplement"
11278976|NCT02791945|EG001|Reported Event|Placebo|"Placebo capsules daily - up to 3200 mg~Medical Management Counseling: Brief alcohol counseling~Placebo: Placebo comparator"
11278977|NCT02792049|BG000|Baseline|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
11278978|NCT02792049|BG001|Baseline|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
11278979|NCT02792049|BG002|Baseline|Total|Total of all reporting groups
11278980|NCT02792049|FG000|Participant Flow|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
11278981|NCT02792049|FG001|Participant Flow|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
11278982|NCT02792049|OG000|Outcome|Modified Ambu Spur II Bag Valve Mask|A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
11278983|NCT02792049|OG001|Outcome|Conventional Ambu Spur II Bag Valve Mask|A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
11278984|NCT02792049|OG000|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
11278985|NCT02792049|OG001|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
11278986|NCT02792049|EG000|Reported Event|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
11278987|NCT02792049|EG001|Reported Event|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
11278988|NCT02792062|BG000|Baseline|TAK-385: Fasted+ Before Breakfast + After Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278989|NCT02792062|BG001|Baseline|TAK-385: Before Breakfast+ After Breakfast + Fasted|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
11278990|NCT02792062|BG002|Baseline|TAK-385: After Breakfast+ Fasted + Before Breakfast|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278991|NCT02792062|BG003|Baseline|TAK-385: Fasted+ After Breakfast + Before Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278992|NCT02792062|BG004|Baseline|TAK-385: Before Breakfast+ Fasted + After Breakfast|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278993|NCT02792062|BG005|Baseline|TAK-385: After Breakfast+ Before Breakfast + Fasted|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
11278994|NCT02792062|BG006|Baseline|Total|Total of all reporting groups
11278995|NCT02792062|FG000|Participant Flow|TAK-385: Fasted+ Before Breakfast + After Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278996|NCT02792062|FG001|Participant Flow|TAK-385: Before Breakfast+ After Breakfast + Fasted|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
11287049|NCT02896569|BG001|Baseline|Standard of Care|No topical therapies for 24 hours post-radio-frequency treatment of the face
11287050|NCT02896569|BG002|Baseline|Total|Total of all reporting groups
11287051|NCT02896569|FG000|Participant Flow|Topical Combination Therapy|"Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face~Topical combination therapy"
11278997|NCT02792062|FG002|Participant Flow|TAK-385: After Breakfast+ Fasted + Before Breakfast|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278998|NCT02792062|FG003|Participant Flow|TAK-385: Fasted+ After Breakfast + Before Breakfast|TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11278999|NCT02792062|FG004|Participant Flow|TAK-385: Before Breakfast+ Fasted + After Breakfast|TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
11279000|NCT02792062|FG005|Participant Flow|TAK-385: After Breakfast+ Before Breakfast + Fasted|TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
11279001|NCT02792062|OG000|Outcome|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
11279002|NCT02792062|OG001|Outcome|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
11279003|NCT02792062|OG002|Outcome|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
11279004|NCT02792062|EG000|Reported Event|TAK-385 40 mg Fasted|TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
11279005|NCT02792062|EG001|Reported Event|TAK-385 40 mg Before Breakfast|TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
11279006|NCT02792062|EG002|Reported Event|TAK-385 40 mg After Breakfast|TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
11279007|NCT02792192|BG000|Baseline|Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC)|Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.
11279008|NCT02792192|BG001|Baseline|Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)|During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279009|NCT02792192|BG002|Baseline|Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279010|NCT02792192|BG003|Baseline|Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279011|NCT02792192|BG004|Baseline|Total|Total of all reporting groups
11279012|NCT02792192|FG000|Participant Flow|Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC)|Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.
11279013|NCT02792192|FG001|Participant Flow|Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)|During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11287052|NCT02896569|FG001|Participant Flow|Standard of Care|No topical therapies for 24 hours post-radio-frequency treatment of the face
11279014|NCT02792192|FG002|Participant Flow|Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279015|NCT02792192|FG003|Participant Flow|Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279016|NCT02792192|OG000|Outcome|Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC)|Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.
11279017|NCT02792192|OG001|Outcome|Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)|During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279018|NCT02792192|OG002|Outcome|Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279019|NCT02792192|OG003|Outcome|Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279020|NCT02792192|OG000|Outcome|Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)|During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279021|NCT02792192|EG000|Reported Event|Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC)|Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.
11279022|NCT02792192|EG001|Reported Event|Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)|During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279023|NCT02792192|EG002|Reported Event|Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279024|NCT02792192|EG003|Reported Event|Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC)|During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
11279025|NCT02792218|BG000|Baseline|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279026|NCT02792218|BG001|Baseline|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279027|NCT02792218|BG002|Baseline|Total|Total of all reporting groups
11279028|NCT02792218|FG000|Participant Flow|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279029|NCT02792218|FG001|Participant Flow|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279030|NCT02792218|OG000|Outcome|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279031|NCT02792218|OG001|Outcome|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279032|NCT02792218|EG000|Reported Event|OMB 20mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279033|NCT02792218|EG001|Reported Event|TER 14mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279034|NCT02792231|BG000|Baseline|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279035|NCT02792231|BG001|Baseline|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279036|NCT02792231|BG002|Baseline|Total|Total of all reporting groups
11279037|NCT02792231|FG000|Participant Flow|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279038|NCT02792231|FG001|Participant Flow|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279039|NCT02792231|OG000|Outcome|OMB 20 mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279040|NCT02792231|OG001|Outcome|TER 14 mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279041|NCT02792231|EG000|Reported Event|OMB 20mg|Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)
11279042|NCT02792231|EG001|Reported Event|TER 14mg|Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
11279043|NCT02792504|BG000|Baseline|Duavive|Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
10820401|NCT00057785|FG000|Participant Flow|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
10820402|NCT00057785|OG000|Outcome|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
10820403|NCT00057785|EG000|Reported Event|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
11279044|NCT02792504|FG000|Participant Flow|Duavive|Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11279045|NCT02792504|OG000|Outcome|Duavive|Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11279046|NCT02792504|EG000|Reported Event|Duavive|Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
11279047|NCT02792517|BG000|Baseline|Erenumab 140 mg + Estrogen/Progestin Contraceptive|Participants received a combination oral contraceptive for three 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.
11279048|NCT02792517|FG000|Participant Flow|Erenumab 140 mg + Estrogen/Progestin Contraceptive|Participants received a combination oral contraceptive for three 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.
11279049|NCT02792517|OG000|Outcome|Erenumab 140 mg + Estrogen/Progestin Contraceptive|Participants received a combination oral contraceptive for three 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.
11279050|NCT02792517|EG000|Reported Event|Erenumab 140 mg + Estrogen/Progestin Contraceptive|Participants received a combination oral contraceptive for three 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.
11279051|NCT02792699|BG000|Baseline|ABP 798 / ABP 798|Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279052|NCT02792699|BG001|Baseline|Rituximab (EU) / Rituximab (EU)|Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279053|NCT02792699|BG002|Baseline|Rituximab (US) / ABP 798|Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279054|NCT02792699|BG003|Baseline|Total|Total of all reporting groups
11279055|NCT02792699|FG000|Participant Flow|ABP 798 / ABP 798|Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279056|NCT02792699|FG001|Participant Flow|Rituximab (EU) / Rituximab (EU)|Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279057|NCT02792699|FG002|Participant Flow|Rituximab (US) / ABP 798|Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
10820404|NCT00057811|BG000|Baseline|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
10820405|NCT00057811|BG001|Baseline|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
11279058|NCT02792699|OG000|Outcome|ABP 798|Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
11279059|NCT02792699|OG001|Outcome|Rituximab (EU)|Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
11279060|NCT02792699|OG002|Outcome|Rituximab (US)|Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
11279061|NCT02792699|OG003|Outcome|Rituximab (US + EU)|Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
11279062|NCT02792699|OG000|Outcome|ABP 798 / ABP 798|Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279063|NCT02792699|OG001|Outcome|Rituximab (EU) / Rituximab (EU)|Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279064|NCT02792699|OG002|Outcome|Rituximab (US) / ABP 798|Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279065|NCT02792699|EG000|Reported Event|Weeks 1-24: ABP 798|Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
11279066|NCT02792699|EG001|Reported Event|Weeks 1-24: Rituximab (EU)|Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
11279067|NCT02792699|EG002|Reported Event|Weeks 1-24: Rituximab (US)|Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
11279068|NCT02792699|EG003|Reported Event|Weeks 1-48: ABP 798 / ABP 798|Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279069|NCT02792699|EG004|Reported Event|Weeks 1-48: Rituximab (EU) / Rituximab (EU)|Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279070|NCT02792699|EG005|Reported Event|Weeks 1-48: Rituximab (US) / ABP 798|Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
11279071|NCT02792777|BG000|Baseline|Interviews|"Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.~Interviews: Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis."
11279072|NCT02792777|BG001|Baseline|Concept Mapping|"Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people.~Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions:~Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement.~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance.~CM Software detects underlying similarities/differences between statements to generate point maps. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.~Step 3: Interpretation- The CM group revises the concept map. Participants review cluster names suggested by the software and decide upon final naming of each cluster."
11279073|NCT02792777|BG002|Baseline|Total|Total of all reporting groups
11279074|NCT02792777|FG000|Participant Flow|Interviews|"Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.~Interviews: Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis."
11279075|NCT02792777|FG001|Participant Flow|Concept Mapping|"Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people.~Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions:~Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement.~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance.~CM Software detects underlying similarities/differences between statements to generate point maps. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.~Step 3: Interpretation- The CM group revises the concept map. Participants review cluster names suggested by the software and decide upon final naming of each cluster."
10820406|NCT00057811|BG002|Baseline|Total|Total of all reporting groups
11279076|NCT02792777|OG000|Outcome|Interviews|"Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.~Interviews: Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis."
11279077|NCT02792777|OG001|Outcome|Concept Mapping|"Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people.~Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions:~Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement.~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance.~CM Software detects underlying similarities/differences between statements to generate point maps. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.~Step 3: Interpretation- The CM group revises the concept map. Participants review cluster names suggested by the software and decide upon final naming of each cluster."
11279078|NCT02792777|OG000|Outcome|Concept Mapping|"Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people.~Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions:~Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement.~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance.~CM Software detects underlying similarities/differences between statements to generate point maps. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.~Step 3: Interpretation- The CM group revises the concept map. Participants review cluster names suggested by the software and decide upon final naming of each cluster."
11279079|NCT02792777|EG000|Reported Event|Interviews|"Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.~Interviews: Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis."
11279080|NCT02792777|EG001|Reported Event|Concept Mapping|"Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people.~Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions:~Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement.~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance.~CM Software detects underlying similarities/differences between statements to generate point maps. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.~Step 3: Interpretation- The CM group revises the concept map. Participants review cluster names suggested by the software and decide upon final naming of each cluster."
11279081|NCT02792829|BG000|Baseline|Arm 1: 11 mg Lenvatinib Suspension in Water|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279082|NCT02792829|BG001|Baseline|Arm 1: 11 mg Lenvatinib Capsule With Water|On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279083|NCT02792829|BG002|Baseline|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11287053|NCT02896569|OG000|Outcome|Topical Combination Therapy|"Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face~Topical combination therapy"
10820407|NCT00057811|FG000|Participant Flow|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
10820408|NCT00057811|FG001|Participant Flow|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
10820409|NCT00057811|OG000|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
11279084|NCT02792829|BG003|Baseline|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279085|NCT02792829|BG004|Baseline|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279086|NCT02792829|BG005|Baseline|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279087|NCT02792829|BG006|Baseline|Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279088|NCT02792829|BG007|Baseline|Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279089|NCT02792829|BG008|Baseline|Total|Total of all reporting groups
11279090|NCT02792829|FG000|Participant Flow|Arm 1: Lenvatinib 11 mg: Suspension+ Capsules (CAP)|Participants received lenvatinib 11 mg (milligram), suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11 mg, capsules (1 capsules of 10mg and 1 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279091|NCT02792829|FG001|Participant Flow|Arm 1: Lenvatinib 11 mg: CAP+ Suspension|Participants received lenvatinib 11 mg, capsules (1 capsules of 10mg and 1 capsules of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11 mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279092|NCT02792829|FG002|Participant Flow|Arm 2:Lenvatinib 11mg Suspension:5 CAP-Water+2 Cap-Apple Juice|Participants received lenvatinib 11mg, suspension in water (prepared using 2 capsule of 4 mg each and 3 capsule of 1 mg each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in apple juice (prepared using 1 capsules of 10mg and 1 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
10820410|NCT00057811|OG001|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
11092351|NCT01539291|EG001|Reported Event|IDL+R (PD) to IDL 300 mg|Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received IDL 150 mg tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 300 mg tablet twice daily.
11279093|NCT02792829|FG003|Participant Flow|Arm 2:Lenvatinib 11mg Suspension:5 CAP-Apple Juice+2 CAP-Water|Participants received lenvatinib 11mg, suspension in apple juice (prepared using 2 capsule of 4 mg each and 3 capsule of 1 mg each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11287054|NCT02896569|OG001|Outcome|Standard of Care|No topical therapies for 24 hours post-radio-frequency treatment of the face
10820411|NCT00057811|EG000|Reported Event|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
11279094|NCT02792829|FG004|Participant Flow|Arm 2:Lenvatinib 11mg Suspension:2 CAP-Water+5 CAP-Apple Juice|Participants received lenvatinib 11mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in apple juice (prepared using 2 capsules of 4 mg each and 3 capsules of 1 mg each) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279095|NCT02792829|FG005|Participant Flow|Arm 2:Lenvatinib 11mg Suspension:2 CAP-Apple Juice+5 CAP-Water|Participants received lenvatinib 11mg, suspension in apple juice (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in water (prepared using 2 capsules of 4 mg each and 3 capsules of 1 mg) on Day 8 on Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279096|NCT02792829|FG006|Participant Flow|Arm 3:Lenvatinib 23mg Suspension Taken at:23 Hours+2 Hours|Participants received lenvatinib 11mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279097|NCT02792829|FG007|Participant Flow|Arm 3:Lenvatinib 23mg Suspension Taken at:2 Hours+23 Hours|Participants received lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279098|NCT02792829|OG000|Outcome|Arm 1: 11 mg Lenvatinib Suspension in Water|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279099|NCT02792829|OG001|Outcome|Arm 1: 11 mg Lenvatinib Capsule With Water|On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279100|NCT02792829|OG002|Outcome|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279101|NCT02792829|OG003|Outcome|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279102|NCT02792829|OG004|Outcome|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279103|NCT02792829|OG005|Outcome|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
10820412|NCT00057811|EG001|Reported Event|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
11279104|NCT02792829|OG006|Outcome|Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279105|NCT02792829|OG007|Outcome|Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279106|NCT02792829|OG002|Outcome|Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279107|NCT02792829|OG003|Outcome|Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279108|NCT02792829|OG004|Outcome|Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279109|NCT02792829|OG005|Outcome|Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279110|NCT02792829|OG007|Outcome|Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279111|NCT02792829|OG004|Outcome|Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water)|Arm 2 group description: On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279112|NCT02792829|OG007|Outcome|Arm 3: 11 mg Lenvatinib Suspension in Water (2 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279113|NCT02792829|OG002|Outcome|Lenvatinib 11 mg (Suspension of 5 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279114|NCT02792829|EG000|Reported Event|Arm 1: 11 mg Lenvatinib Suspension in Water|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
10822109|NCT00074490|OG001|Outcome|Arm IVD Cohort 3 (Multiple Th2 DLI)|Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
11279115|NCT02792829|EG001|Reported Event|Arm 1: 11 mg Lenvatinib Capsule With Water|On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279116|NCT02792829|EG002|Reported Event|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279117|NCT02792829|EG003|Reported Event|Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279118|NCT02792829|EG004|Reported Event|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279119|NCT02792829|EG005|Reported Event|Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice)|On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279120|NCT02792829|EG006|Reported Event|Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279121|NCT02792829|EG007|Reported Event|Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours)|On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
11279122|NCT02792959|BG000|Baseline|Functional Imaging|"A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)~Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1~Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval"
11279123|NCT02792959|FG000|Participant Flow|Functional Imaging|"A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)~Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1~Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval"
11279124|NCT02792959|OG000|Outcome|Functional Imaging|"A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)~Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1~Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval"
11279125|NCT02792959|EG000|Reported Event|Functional Imaging|"A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)~Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1~Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval"
11287055|NCT02896569|EG000|Reported Event|Topical Combination Therapy|"Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face~Topical combination therapy"
11279126|NCT02793128|BG000|Baseline|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen."
11279127|NCT02793128|FG000|Participant Flow|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT).~Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed low grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the Primary Disease Evaluation (PDE) Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen."
11279128|NCT02793128|OG000|Outcome|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen."
11279129|NCT02793128|OG000|Outcome|UGN-101 Mitomycin for Pyelocalyceal Solution|"Population was analyzed at 12 months post Primary Disease Evaluation (PDE) visit. 8 out of 41 patients had disease recurrence. The Kaplan-Meier estimate of 12 month duration of complete response (CR) rate was 82%.~This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT).~Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed low grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen."
11279130|NCT02793128|OG000|Outcome|UGN-101 Patients Evaluated 3 Months Post PDE|Patients reaching CR at PDE evaluated at 3 months post PDE
11279131|NCT02793128|OG001|Outcome|UGN-101 Patients Evaluated at 6 Months Post PDE|Patients reaching CR at PDE evaluated at 6 months post PDE
11279132|NCT02793128|OG002|Outcome|UGN-101 Patients Evaluated at 9 Months Post PDE|Patients reaching CR at PDE evaluated at 9 months post PDE
11279133|NCT02793128|OG003|Outcome|UGN-101 Patients Evaluated at 12 Months Post PDE|Patients reaching CR at PDE evaluated at 12 months post PDE
11279134|NCT02793128|OG000|Outcome|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the UUT.~Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen."
11279135|NCT02793128|OG000|Outcome|Pharmacokinetic Population|The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.
11279136|NCT02793128|OG000|Outcome|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT).~Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed low grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen."
11279137|NCT02793128|EG000|Reported Event|UGN-101 Mitomycin for Pyelocalyceal Solution|"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT).~Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.~Eligible patients with confirmed Low Grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the Primary Disease Evaluation (PDE) Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen."
11279138|NCT02793154|BG000|Baseline|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
11287056|NCT02896569|EG001|Reported Event|Standard of Care|No topical therapies for 24 hours post-radio-frequency treatment of the face
10820413|NCT00057837|BG000|Baseline|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
10820414|NCT00057837|BG001|Baseline|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
11279139|NCT02793154|BG001|Baseline|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
11279140|NCT02793154|BG002|Baseline|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
11279141|NCT02793154|BG003|Baseline|Total|Total of all reporting groups
11279142|NCT02793154|FG000|Participant Flow|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
11279143|NCT02793154|FG001|Participant Flow|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
11279144|NCT02793154|FG002|Participant Flow|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
11279145|NCT02793154|OG000|Outcome|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
11279146|NCT02793154|OG000|Outcome|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
11279147|NCT02793154|OG001|Outcome|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
11279148|NCT02793154|EG000|Reported Event|Part A: Exenatide SC Injection|Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
11279149|NCT02793154|EG001|Reported Event|Part B: Exenatide SC Injection|Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
11279150|NCT02793154|EG002|Reported Event|Part B: Albiglutide SC Injection|Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
11279151|NCT02793232|BG000|Baseline|Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed|Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
11279152|NCT02793232|BG001|Baseline|Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
11279153|NCT02793232|BG002|Baseline|Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
10820415|NCT00057837|BG002|Baseline|Total|Total of all reporting groups
11279154|NCT02793232|BG003|Baseline|Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days.
11279155|NCT02793232|BG004|Baseline|Part B: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279156|NCT02793232|BG005|Baseline|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279157|NCT02793232|BG006|Baseline|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279158|NCT02793232|BG007|Baseline|Part C: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279159|NCT02793232|BG008|Baseline|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279160|NCT02793232|BG009|Baseline|Total|Total of all reporting groups
11279161|NCT02793232|FG000|Participant Flow|Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed|Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
11279162|NCT02793232|FG001|Participant Flow|Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
11279163|NCT02793232|FG002|Participant Flow|Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
11279164|NCT02793232|FG003|Participant Flow|Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo|Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days.
11279165|NCT02793232|FG004|Participant Flow|Part B: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279166|NCT02793232|FG005|Participant Flow|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279167|NCT02793232|FG006|Participant Flow|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279168|NCT02793232|FG007|Participant Flow|Part C: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279169|NCT02793232|FG008|Participant Flow|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279170|NCT02793232|OG000|Outcome|Part A: Placebo|All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279171|NCT02793232|OG001|Outcome|Part A: PF-06751979 200 mg|All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279172|NCT02793232|OG002|Outcome|Part A: PF-06751979 400 mg|All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279173|NCT02793232|OG003|Outcome|Part A: PF-06751979 540 mg|All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279174|NCT02793232|OG004|Outcome|Part A: PF-06751979 200 mg Fed|All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279175|NCT02793232|OG005|Outcome|Part B: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279176|NCT02793232|OG006|Outcome|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279177|NCT02793232|OG007|Outcome|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279178|NCT02793232|OG008|Outcome|Part C: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279179|NCT02793232|OG009|Outcome|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279180|NCT02793232|OG000|Outcome|Part B: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279181|NCT02793232|OG001|Outcome|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279182|NCT02793232|OG002|Outcome|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279183|NCT02793232|OG003|Outcome|Part C: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279184|NCT02793232|OG004|Outcome|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279185|NCT02793232|OG000|Outcome|Part A: PF-06751979 200 mg|All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279186|NCT02793232|OG001|Outcome|Part A: PF-06751979 400 mg|All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279187|NCT02793232|OG002|Outcome|Part A: PF-06751979 540 mg|All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279188|NCT02793232|OG003|Outcome|Part A: PF-06751979 200 mg Fed|All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279189|NCT02793232|OG000|Outcome|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279190|NCT02793232|OG001|Outcome|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279191|NCT02793232|OG000|Outcome|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279192|NCT02793232|EG000|Reported Event|Part A: Placebo|All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279193|NCT02793232|EG001|Reported Event|Part A: PF-06751979 200 mg|All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279194|NCT02793232|EG002|Reported Event|Part A: PF-06751979 400 mg|All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279195|NCT02793232|EG003|Reported Event|Part A: PF-06751979 540 mg|All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279196|NCT02793232|EG004|Reported Event|Part A: PF-06751979 200 mg Fed|All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
11279197|NCT02793232|EG005|Reported Event|Part B: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279198|NCT02793232|EG006|Reported Event|Part B: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279199|NCT02793232|EG007|Reported Event|Part B: PF-06751979 275 mg|Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication
11279200|NCT02793232|EG008|Reported Event|Part C: Placebo|Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279201|NCT02793232|EG009|Reported Event|Part C: PF-06751979 125 mg|Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
11279202|NCT02793622|BG000|Baseline|Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy"
11279203|NCT02793622|BG001|Baseline|Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy"
11279204|NCT02793622|BG002|Baseline|Total|Total of all reporting groups
11279205|NCT02793622|FG000|Participant Flow|Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy"
11279206|NCT02793622|FG001|Participant Flow|Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy"
11279207|NCT02793622|OG000|Outcome|Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy"
11279208|NCT02793622|OG001|Outcome|Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy"
11279209|NCT02793622|EG000|Reported Event|Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy|"Women will be given SP (3 full strength tabs, 500 mg/25 mg) every four weeks times during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy"
11279210|NCT02793622|EG001|Reported Event|Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy|"Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP.~Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy"
11279211|NCT02793674|BG000|Baseline|Fisher & Paykel (FP) HFNC|"A subgroup was studied on Fisher & Paykel (FP) high flow nasal cannula (HFNC) exclusively (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279212|NCT02793674|BG001|Baseline|Vapotherm (VT) HFNC|"A subgroup was studied on Vapotherm (VT) high flow nasal cannula (HFNC) (N=12). These patients then crossed over to the other arm and had back-to-back titrations on both types of HFNC (FP and VT). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279213|NCT02793674|BG002|Baseline|Total|Total of all reporting groups
11279214|NCT02793674|FG000|Participant Flow|Fisher & Paykel (FP) HFNC|"A subgroup of participants were placed exclusively on Fisher & Paykel (FP) high flow nasal cannula (HFNC) (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279215|NCT02793674|FG001|Participant Flow|Vapotherm (VT) HFNC|"A subgroup of patients (N=12) had flow titrations performed on both Fisher & Paykel (FP) and Vapotherm (VT) high flow nasal cannula (HFNC) delivery systems. The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions. These patients had flow titrations on both HFNC delivery systems performed to compare EOB on these two different HFNC delivery systems. With one exception, titrations were performed on FP first, then crossed over to VT.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279216|NCT02793674|OG000|Outcome|Percent Change in Pressure-Rate Product|"All participants in the study were placed on high flow nasal cannula (HFNC). For this outcome, the median percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279217|NCT02793674|OG000|Outcome|Pressure-Rate Product|"All participants in the study were placed on high flow nasal cannula (HFNC). or this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.~Measurements of effort of breathing was obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time was allowed at each flow rate for stabilization of EOB and flow levels were trialed in a random order, each for approximately 5 minutes."
11279218|NCT02793674|OG000|Outcome|Phase Angle|The phase angle was measured at all flow titrations for all patients on both types of HFNC delivery systems (FP and VT). This is a measure of thoracoabdominal asynchrony and a proxy for effort of breathing.
11279219|NCT02793674|OG000|Outcome|Fisher & Paykel HFNC Delivery System|This arm shows the outcome (the median of the percent change in PRP from baseline as a function of flow rate) for these patients when they were studied on the FP HFNC delivery system.
11279220|NCT02793674|OG001|Outcome|Vapotherm HFNC Delivery System|This arm shows the outcome (the median of the percent change in PRP from baseline as a function of flow rate) for these patients when they were studied on the VT HFNC delivery system.
11279221|NCT02793674|OG000|Outcome|Less Than or Equal to 8 kg|The percent change in Pressure-rate Product (PRP) from baseline as a function of increasing HFNC flow rate was analyzed comparing weight-stratified subgroups. This analysis looked at the first titration performed on the HFNC delivery system for patients less than or equal to 8 kg (12 patients, 20 episodes) and greater than 8 kg (9 patients, 12 episodes). This outcome was derived from flow titraitons on both types of HFNC delivery system (FP and VT).
11279222|NCT02793674|OG001|Outcome|Greater Than 8 kg|The percent change in Pressure-rate Product (PRP) from baseline as a function of increasing HFNC flow rate was analyzed comparing weight-stratified subgroups. This analysis looked at the first titration performed on the HFNC delivery system for patients less than or equal to 8 kg (12 patients, 20 episodes) and greater than 8 kg (9 patients, 12 episodes). This outcome was derived from flow titraitons on both types of HFNC delivery system (FP and VT).
11279223|NCT02793674|OG000|Outcome|Maximum Percent Change in PRP From Baseline Stratified by Wt|This analysis looked at the largest decrease in PRP for all flow titrations for weight stratified subgroups. For this outcome, the maximum percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).
11279224|NCT02793674|EG000|Reported Event|Fisher & Paykel (FP) High Flow Nasal Cannula|A subgroup was studied on Fisher & Paykel (FP) high flow nasal cannula (HFNC) exclusively (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.
11279225|NCT02793674|EG001|Reported Event|Vapotherm (VT) High Flow Nasal Cannula|A subgroup was studied on Vapotherm (VT) high flow nasal cannula (HFNC) (N=12). These patients then crossed over to the other arm and had back-to-back titrations on both types of HFNC (FP and VT). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.
11279226|NCT02793817|BG000|Baseline|KPI-121 1.0% Ophthalmic Suspension|"dosed BID~KPI-121 1% Ophthalmic Suspension dosed BID"
11279227|NCT02793817|BG001|Baseline|Vehicle of KPI-121 Ophthalmic Suspension|"dosed BID~Vehicle of KPI-121 Ophthalmic Suspension dosed BID"
11279228|NCT02793817|BG002|Baseline|Total|Total of all reporting groups
11279229|NCT02793817|FG000|Participant Flow|KPI-121 1.0% Ophthalmic Suspension|"dosed BID~KPI-121 1% Ophthalmic Suspension dosed BID"
11279230|NCT02793817|FG001|Participant Flow|Vehicle of KPI-121 Ophthalmic Suspension|"dosed BID~Vehicle of KPI-121 Ophthalmic Suspension dosed BID"
11279231|NCT02793817|OG000|Outcome|KPI-121 1% Ophthalmic Suspension|KPI-121 1% Ophthalmic Suspension dosed BID
11279232|NCT02793817|OG001|Outcome|Vehicle of KPI-121 1% Ophthalmic Suspension|Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
11279233|NCT02793817|EG000|Reported Event|KPI-121 1% Ophthalmic Suspension|KPI-121 1% Ophthalmic Suspension dosed BID
11279234|NCT02793817|EG001|Reported Event|Vehicle of KPI-121 1% Ophthalmic Suspension|Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
11337664|NCT03590613|FG003|Participant Flow|Treatment Sequence D: 60mg TID /120mg TID /240mg TID /PBO TID|Participants in this arm received GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, GSK2982772 240 mg TID in TP3 and PBO TID in TP4. GSK2982772 and placebo was administered at 0 hour (starting dose), 7 hours (second dose) and 14 hours (third dose) on Day 1 in each TP. Participants had fasted overnight for 8 hours before first dose. Each TP was followed by a washout period of at least 7 days, for each participant.
11337665|NCT03590613|OG000|Outcome|Placebo|Participants were administered PBO matching GSK2982772 via oral route using a 7 hours dosing interval in each TP.
11279235|NCT02793856|BG000|Baseline|Pre-A-One Cycle|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279236|NCT02793856|BG001|Baseline|A - Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 1 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279237|NCT02793856|BG002|Baseline|B- Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279238|NCT02793856|BG003|Baseline|C- Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 4 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279239|NCT02793856|BG004|Baseline|Total|Total of all reporting groups
11279240|NCT02793856|FG000|Participant Flow|Pre-A-One Cycle|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle which is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279241|NCT02793856|FG001|Participant Flow|A - Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 1 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279242|NCT02793856|FG002|Participant Flow|B- Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11287057|NCT02896595|BG000|Baseline|General Anesthesia With Endotracheal Tube|"Patients assigned to the ETT tube group will have ETT placed in the safest manner deemed appropriate by attending anesthesiologist. Possible ways to have ETT placed will be using direct laryngoscopy, glidescope or fiberoptic intubations. Size of ETT will be decided based on patient characteristics and discretion of attending anesthesiologist. Once placed, auscultation and capnography will be used to ensure correct placement of ETT.~General Anesthesia with endotracheal tube: Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11279243|NCT02793856|FG003|Participant Flow|C- Two Cycles|"Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.~A total of 4 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.~Cyclophosphamide: To deplete Tregs before collecting peripheral blood~PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment"
11279244|NCT02793856|OG000|Outcome|Pre-A Cohort|All adverse events are grade 1-2.
11279245|NCT02793856|OG001|Outcome|A Cohort|All adverse events are grade 1-2.
11279246|NCT02793856|OG002|Outcome|B Cohort|All adverse events are grade 1-2.
11279247|NCT02793856|OG003|Outcome|C Cohort|All adverse events are grade 1-2.
11279248|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, all patient were assessed per RECIST v1.1
11279249|NCT02793856|OG001|Outcome|A Cohort|In A Cohort, 3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.
11279250|NCT02793856|OG002|Outcome|B Cohort|In B Cohort, all patients were assessed per RECIST v1.1.
11279251|NCT02793856|OG003|Outcome|C Cohort|In C Cohort, all patients were assessed per RECIST v1.1.
11279252|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, all two patients were assessed per RECIST v1.1.
11279253|NCT02793856|OG001|Outcome|A Cohort|3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.
11279254|NCT02793856|OG003|Outcome|C Cohort|All patients were assessed per RECIST v1.1.
11279255|NCT02793856|OG001|Outcome|A Cohort|All patients were assessed per RECIST v1.1.
11279256|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, two patients were followed up.
11279257|NCT02793856|OG001|Outcome|A Cohort|All patients were followed up.
11279258|NCT02793856|OG002|Outcome|B Cohort|In B Cohort, all patients were followed up.
11279259|NCT02793856|OG003|Outcome|C Cohort|All patients were followed up.
11279260|NCT02793856|OG000|Outcome|Pre-A Cohort|All patients were tested for gene mutation status in ctDNA at baseline
11279261|NCT02793856|OG001|Outcome|A Cohort|All patients were tested for gene mutation status in ctDNA at baseline
11279262|NCT02793856|OG002|Outcome|B Cohort|All patients were tested for gene mutation status in ctDNA at baseline
11279263|NCT02793856|OG003|Outcome|C Cohort|All patients were tested for gene mutation status in ctDNA at baseline
11279264|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, one patient provided blood smaple at baseline, month 1 and month 3, the other patient provided blood sample only at baseline and month 1.
11279265|NCT02793856|OG001|Outcome|A Cohort|Three patients were collected blood at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to samples at month 3.
11279266|NCT02793856|OG002|Outcome|B Cohort|In B Cohort, One patient's blood was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline and month 1 owing to PD before month 3.
11279267|NCT02793856|OG003|Outcome|C Cohort|In C Cohort, One patient's blood was collected blood at baseline, month 1 and month 3. The other two patients' blood were only collected blood at baseline and month 1, owing to PD before month 3.
11279268|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, one patient's blood was collected blood at baseline, month 1 and month 3, the other patient's blood was collected at baseline and month 1.
11279269|NCT02793856|OG001|Outcome|A Cohort|Three patients' samples were collected at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and did not provide samples at month 3
11279270|NCT02793856|OG002|Outcome|B Cohort|In B Cohort, One patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3.
11279271|NCT02793856|OG003|Outcome|C Cohort|In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3.
11279272|NCT02793856|OG000|Outcome|Pre-A Cohort|In Pre-A Cohort, one patient's blood was collected at baseline, month 1 and month 3, the other patient's blood was collected only at baseline and month 1.
11279273|NCT02793856|OG001|Outcome|A Cohort|Three patients provided blood samples at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to provide samples at month 3
11279274|NCT02793856|OG002|Outcome|B Cohort|In B Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3.
11279275|NCT02793856|OG003|Outcome|C Cohort|In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3.
11279276|NCT02793856|EG000|Reported Event|Pre-A Cohort|Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.
11279277|NCT02793856|EG001|Reported Event|A Cohort|Grade 1/2 treatment-related adverse events (AEs) occurred in 4 patients.
11279278|NCT02793856|EG002|Reported Event|B Cohort|Grade 1/2 treatment-related adverse events (AEs) occurred in 3 patients.
11279279|NCT02793856|EG003|Reported Event|C Cohort|Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.
11279280|NCT02793947|BG000|Baseline|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
11279281|NCT02793947|BG001|Baseline|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
11279282|NCT02793947|BG002|Baseline|Total|Total of all reporting groups
11279283|NCT02793947|FG000|Participant Flow|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
11279284|NCT02793947|FG001|Participant Flow|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
11279285|NCT02793947|OG000|Outcome|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
11279286|NCT02793947|OG001|Outcome|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
11279287|NCT02793947|EG000|Reported Event|Peri-incisional Injection|A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. The cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
11279288|NCT02793947|EG001|Reported Event|Control (no Injection)|Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
11279289|NCT02794103|BG000|Baseline|Projector-based Virtual Reality Distraction|Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
11279290|NCT02794103|FG000|Participant Flow|Projector-based Virtual Reality Distraction|Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
11279291|NCT02794103|OG000|Outcome|Projector-based Virtual Reality Distraction|Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
11279292|NCT02794103|EG000|Reported Event|Projector-based Virtual Reality Distraction|Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
11279293|NCT02794207|BG000|Baseline|Patients|Patients who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided).
11279294|NCT02794207|BG001|Baseline|Caregivers|Caregivers who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided).
11279295|NCT02794207|BG002|Baseline|Total|Total of all reporting groups
11279296|NCT02794207|FG000|Participant Flow|Participants|One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included.
11279297|NCT02794207|FG001|Participant Flow|Caregivers|One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included.
11279298|NCT02794207|OG000|Outcome|Participants|One qualitative, semi-structured interview will be conducted. Each interview lasted approximately 30-45 minutes and were audio recorded (if consent is provided). Interviews consisted of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes were also included.
11279299|NCT02794207|EG000|Reported Event|Participants|One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included.
11337666|NCT03590613|OG001|Outcome|GSK2982772 60 mg|Participants were administered GSK2982772 60 mg via oral route using a 7 hours dosing interval in each TP.
11337667|NCT03590613|OG002|Outcome|GSK2982772 120 mg|Participants were administered GSK2982772 120 mg via oral route using a 7 hours dosing interval in each TP.
11279300|NCT02794207|EG001|Reported Event|Caregivers|One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included.
11279301|NCT02794246|BG000|Baseline|Single Arm|CART-19 cells
11279302|NCT02794246|FG000|Participant Flow|CART-19 Cells|single infusion of 1-5x10E8 cells CART-19 cells
11279303|NCT02794246|OG000|Outcome|Single Arm|CART-19 cells
11279304|NCT02794246|EG000|Reported Event|Single Arm|CART-19 cells
11279305|NCT02794441|BG000|Baseline|Dexamethasone|"Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose~Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose"
11279306|NCT02794441|BG001|Baseline|Placebo|"Matched oral solution in same volume per kg as dexamethasone~Placebo: Matched oral solution"
11279307|NCT02794441|BG002|Baseline|Total|Total of all reporting groups
11279308|NCT02794441|FG000|Participant Flow|Dexamethasone|"Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose~Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose"
11279309|NCT02794441|FG001|Participant Flow|Placebo|"Matched oral solution in same volume per kg as dexamethasone~Placebo: Matched oral solution"
11279310|NCT02794441|OG000|Outcome|Dexamethasone|"Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose~Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose"
11279311|NCT02794441|OG001|Outcome|Placebo|"Matched oral solution in same volume per kg as dexamethasone~Placebo: Matched oral solution"
11279312|NCT02794441|EG000|Reported Event|Dexamethasone|"Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose~Dexamethasone: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose"
11279313|NCT02794441|EG001|Reported Event|Placebo|"Matched oral solution in same volume per kg as dexamethasone~Placebo: Matched oral solution"
11279314|NCT02794480|BG000|Baseline|Sub-Study 1 (Seq 3: Ellipta/GSK MDI; Seq 4: GSK MDI/Ellipta)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279315|NCT02794480|BG001|Baseline|Sub-Study 2 (Seq 1: Ellipta/AZ MDI; Seq 2: AZ MDI/Ellipta)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279316|NCT02794480|BG002|Baseline|Total|Total of all reporting groups
11279317|NCT02794480|FG000|Participant Flow|Sub-Study 1 (Seq 3: Ellipta/GSK MDI)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279318|NCT02794480|FG001|Participant Flow|Sub-Study 1 (Seq 4: GSK MDI/Ellipta)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279319|NCT02794480|FG002|Participant Flow|Sub-Study 2 (Seq 1: Ellipta/AZ MDI)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11337668|NCT03590613|OG003|Outcome|GSK2982772 240 mg|Participants were administered GSK2982772 240 mg via oral route using a 7 hours dosing interval in each TP.
11337669|NCT03590613|OG000|Outcome|GSK2982772 60 mg|Participants were administered GSK2982772 60 mg via oral route using a 7 hours dosing interval in each TP.
11337670|NCT03590613|OG001|Outcome|GSK2982772 120 mg|Participants were administered GSK2982772 120 mg via oral route using a 7 hours dosing interval in each TP.
11279320|NCT02794480|FG003|Participant Flow|Sub-Study 2 (Seq 2: AZ MDI/Ellipta)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279321|NCT02794480|OG000|Outcome|Sub-Study 1|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279322|NCT02794480|OG001|Outcome|Sub-Study 2|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279323|NCT02794480|EG000|Reported Event|Sub-Study 1 - Ellipta (Sequence 3,4)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279324|NCT02794480|EG001|Reported Event|Sub-Study 1 - GSK MDI (Sequence 3,4)|Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279325|NCT02794480|EG002|Reported Event|Sub-Study 2 - Ellipta (Sequence 1,2)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279326|NCT02794480|EG003|Reported Event|Sub-Study 2 - AZ MDI (Sequence 1,2)|Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period.
11279327|NCT02794597|BG000|Baseline|Usual Care - Opioid Medication Assisted Treatment|The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
11279328|NCT02794597|BG001|Baseline|Intervention|"Peer-led, behavioral sexual health intervention~Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing."
11279329|NCT02794597|BG002|Baseline|Total|Total of all reporting groups
11279330|NCT02794597|FG000|Participant Flow|Usual Care - Opioid Medication Assisted Treatment (OMAT)|The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to family planning (FP) services.
11279331|NCT02794597|FG001|Participant Flow|Intervention|"Peer-led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE)~Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing."
11279332|NCT02794597|OG000|Outcome|Usual Care - Opioid Medication Assisted Treatment|The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
11279333|NCT02794597|OG001|Outcome|Intervention|"Peer-led, behavioral sexual health intervention~Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing."
11279334|NCT02794597|EG000|Reported Event|Usual Care - Opioid Medication Assisted Treatment|The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
11279335|NCT02794597|EG001|Reported Event|Intervention|"Peer-led, behavioral sexual health intervention~Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing."
11279336|NCT02794727|BG000|Baseline|Blinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.~Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks."
11279337|NCT02794727|BG001|Baseline|Unblinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.~Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals."
11279338|NCT02794727|BG002|Baseline|No Fitbit|Subjects will not wear any activity monitor for 12 weeks.
11279339|NCT02794727|BG003|Baseline|Total|Total of all reporting groups
11279340|NCT02794727|FG000|Participant Flow|Blinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.~Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks."
11279341|NCT02794727|FG001|Participant Flow|Unblinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.~Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals."
11279342|NCT02794727|FG002|Participant Flow|No Fitbit|Subjects will not wear any activity monitor for 12 weeks.
11279343|NCT02794727|OG000|Outcome|Blinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.~Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks."
11279344|NCT02794727|OG001|Outcome|Unblinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.~Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals."
11279345|NCT02794727|EG000|Reported Event|Blinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.~Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks."
11279346|NCT02794727|EG001|Reported Event|Unblinded Fitbit|"Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.~Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals."
11279347|NCT02794727|EG002|Reported Event|No Fitbit|Subjects will not wear any activity monitor for 12 weeks.
11279348|NCT02794766|BG000|Baseline|Inulin+LS|"Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days~Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279349|NCT02794766|BG001|Baseline|L Salivarius|"Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days~L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279350|NCT02794766|BG002|Baseline|Placebo|"Placebo 1 gum per oral each 12 hours, for 10 days~Placebo: Placebo 1 gum each 12 hours for 10 days"
11279351|NCT02794766|BG003|Baseline|Total|Total of all reporting groups
11279352|NCT02794766|FG000|Participant Flow|Inulin+LS|"Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days~Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279353|NCT02794766|FG001|Participant Flow|L Salivarius|"Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days~L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279354|NCT02794766|FG002|Participant Flow|Placebo|"Placebo 1 gum per oral each 12 hours, for 10 days~Placebo: Placebo 1 gum each 12 hours for 10 days"
11279355|NCT02794766|OG000|Outcome|Inulin+LS|"Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days~Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279356|NCT02794766|OG001|Outcome|L Salivarius|"Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days~L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279357|NCT02794766|OG002|Outcome|Placebo|"Placebo 1 gum per oral each 12 hours, for 10 days~Placebo: Placebo 1 gum each 12 hours for 10 days"
11279358|NCT02794766|EG000|Reported Event|Inulin+LS|"Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days~Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279359|NCT02794766|EG001|Reported Event|L Salivarius|"Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days~L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days"
11279360|NCT02794766|EG002|Reported Event|Placebo|"Placebo 1 gum per oral each 12 hours, for 10 days~Placebo: Placebo 1 gum each 12 hours for 10 days"
11279361|NCT02794844|BG000|Baseline|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied."
11279362|NCT02794844|FG000|Participant Flow|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PPI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied."
11279363|NCT02794844|OG000|Outcome|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
11279364|NCT02794844|EG000|Reported Event|Genotype Guided PPI Dosing|"Genotype Guided PPI Dosing: PI type and dosing will be recommended in real time based on patients' CYP2C19 genotype / metabolizer phenotype.~No other ARM will be studied.~Genotype Guided PPI Dosing: Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information."
11279365|NCT02794870|BG000|Baseline|RSV LID ΔM2-2 1030s Vaccine|"Participants received a single dose of the RSV LID ΔM2-2 1030s vaccine at study entry (Day 0).~RSV LID ΔM2-2 1030s vaccine: 10^5.0 PFU; administered as nose drops"
11279366|NCT02794870|BG001|Baseline|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11279367|NCT02794870|BG002|Baseline|Total|Total of all reporting groups
11279368|NCT02794870|FG000|Participant Flow|RSV LID ΔM2-2 1030s Vaccine|"Participants received a single dose of the RSV LID ΔM2-2 1030s vaccine at study entry (Day 0).~RSV LID ΔM2-2 1030s vaccine: 10^5.0 PFU; administered as nose drops"
11279369|NCT02794870|FG001|Participant Flow|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11279370|NCT02794870|OG000|Outcome|RSV LID ΔM2-2 1030s Vaccine|"Participants received a single dose of the RSV LID ΔM2-2 1030s vaccine at study entry (Day 0).~RSV LID ΔM2-2 1030s vaccine: 10^5.0 PFU; administered as nose drops"
11279371|NCT02794870|OG001|Outcome|Placebo|"Participants received a single dose of placebo at study entry (Day 0).~Placebo: Isotonic diluent, administered as nose drops"
11279372|NCT02794870|EG000|Reported Event|Vaccine|"Participants received a single dose of the RSV LID ΔM2-2 1030s vaccine at study entry (Day 0).~RSV LID ΔM2-2 1030s vaccine: 10^5.0 PFU; administered as nose drops"
11279373|NCT02794870|EG001|Reported Event|Placebo|Participants received a single dose of placebo study entry (Day 0). Placebo: Isotonic diluent, administered as nose drops
11279374|NCT02794974|BG000|Baseline|Cervical Plexus, Perivascular and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%~perivascular block: ultrasound-guided application of 5ml prilocaine 1%"
11279375|NCT02794974|BG001|Baseline|Cervical Plexus and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%"
11279376|NCT02794974|BG002|Baseline|Total|Total of all reporting groups
11279377|NCT02794974|FG000|Participant Flow|Cervical Plexus and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%"
11279378|NCT02794974|FG001|Participant Flow|Cervical Plexus, Perivascular and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%~perivascular block: ultrasound-guided application of 5ml prilocaine 1%"
11279379|NCT02794974|OG000|Outcome|Cervical Plexus and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%"
11279380|NCT02794974|OG001|Outcome|Cervical Plexus, Perivascular and Facial Nerve Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%~perivascular block: ultrasound-guided application of 5ml prilocaine 1%"
11279381|NCT02794974|EG000|Reported Event|Without Perivascular Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%"
11337671|NCT03590613|OG002|Outcome|GSK2982772 240 mg|Participants were administered GSK2982772 240 mg via oral route using a 7 hours dosing interval in each TP.
11337672|NCT03590613|EG000|Reported Event|Placebo|Participants were administered PBO matching GSK2982772 via oral route using a 7 hours dosing interval in each TP
11279382|NCT02794974|EG001|Reported Event|With Perivascular Block|"1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) 3. perivascular block (5ml prilocaine 1%)~cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%~facial nerve block: ultrasound-guided application of 5ml prilocaine 1%~perivascular block: ultrasound-guided application of 5ml prilocaine 1%"
11279383|NCT02795117|BG000|Baseline|Test Product|Ivermectin Cream, 1% (Perrigo)
11279384|NCT02795117|BG001|Baseline|Reference Product|Ivermectin Cream, 1% (reference)
11279385|NCT02795117|BG002|Baseline|Placebo|Placebo cream
11279386|NCT02795117|BG003|Baseline|Total|Total of all reporting groups
11279387|NCT02795117|FG000|Participant Flow|Test Product|Ivermectin cream
11279388|NCT02795117|FG001|Participant Flow|Reference Product|Ivermectin (reference) cream
11279389|NCT02795117|FG002|Participant Flow|Placebo|Placebo cream
11279390|NCT02795117|OG000|Outcome|Test Product|Ivermectin cream
11279391|NCT02795117|OG001|Outcome|Reference Product|Ivermectin (reference) cream
11279392|NCT02795117|OG002|Outcome|Placebo|Placebo cream
11279393|NCT02795117|EG000|Reported Event|Test Product|Ivermectin cream
10820416|NCT00057837|FG000|Participant Flow|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
11279394|NCT02795117|EG001|Reported Event|Reference Product|Ivermectin (reference) cream
11279395|NCT02795117|EG002|Reported Event|Placebo|Placebo cream
11279396|NCT02795767|BG000|Baseline|Cohort A: 1.5 mg/kg Emicizumab QW|Participants received emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) once every week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg QW SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279397|NCT02795767|BG001|Baseline|Cohort B: 3 mg/kg Emicizumab Q2W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 3 mg/kg once every 2 weeks (Q2W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279398|NCT02795767|BG002|Baseline|Cohort C: 6 mg/kg Emicizumab Q4W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 6 mg/kg once every 4 weeks (Q4W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279399|NCT02795767|BG003|Baseline|Total|Total of all reporting groups
11279400|NCT02795767|FG000|Participant Flow|Cohort A: 1.5 mg/kg Emicizumab QW|Participants received emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) once every week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg QW SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279401|NCT02795767|FG001|Participant Flow|Cohort B: 3 mg/kg Emicizumab Q2W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 3 mg/kg once every 2 weeks (Q2W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279402|NCT02795767|FG002|Participant Flow|Cohort C: 6 mg/kg Emicizumab Q4W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 6 mg/kg once every 4 weeks (Q4W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279403|NCT02795767|OG000|Outcome|Cohort A: 1.5 mg/kg Emicizumab QW|Participants received emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) once every week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg QW SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279404|NCT02795767|OG000|Outcome|Cohort B: 3 mg/kg Emicizumab Q2W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 3 mg/kg once every 2 weeks (Q2W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279405|NCT02795767|OG001|Outcome|Cohort C: 6 mg/kg Emicizumab Q4W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 6 mg/kg once every 4 weeks (Q4W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279406|NCT02795767|OG000|Outcome|Cohort A NIS Population (<12 Years): Bypassing Agents|This group includes historical data from participants <12 years old who had participated in the non-interventional study (NIS) BH29768 (NCT02476942) in which they had received prophylactic or episodic treatment with bypassing agents and had been followed for a minimum of 24 weeks on the NIS prior to enrollment in Cohort A of this study (BH29992).
11279407|NCT02795767|OG001|Outcome|Cohort A NIS Population (<12 Years): 1.5 mg/kg Emicizumab QW|Participants <12 years old who had previously received prophylactic or episodic treatment with bypassing agents in NIS BH29768 (NCT02476942) and were enrolled in Cohort A of this study (BH29992) received emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) once every week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg emicizumab QW SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279408|NCT02795767|OG001|Outcome|Cohort B: 3 mg/kg Emicizumab Q2W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 3 mg/kg once every 2 weeks (Q2W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279409|NCT02795767|OG002|Outcome|Cohort C: 6 mg/kg Emicizumab Q4W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 6 mg/kg once every 4 weeks (Q4W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279410|NCT02795767|EG000|Reported Event|Cohort A: 1.5 mg/kg Emicizumab QW|Participants received emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) once every week (QW) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg QW SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279411|NCT02795767|EG001|Reported Event|Cohort B: 3 mg/kg Emicizumab Q2W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 3 mg/kg once every 2 weeks (Q2W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279412|NCT02795767|EG002|Reported Event|Cohort C: 6 mg/kg Emicizumab Q4W|Participants received emicizumab at a loading dose of 3 mg/kg QW subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 6 mg/kg once every 4 weeks (Q4W) SC for a minimum of 52 weeks, or until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria set forth in the protocol, whichever occurred first.
11279413|NCT02795780|BG000|Baseline|AD Subjects|Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm
11279414|NCT02795780|BG001|Baseline|MCI Subjects|Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm
11279415|NCT02795780|BG002|Baseline|Total|Total of all reporting groups
11279416|NCT02795780|FG000|Participant Flow|AD Subjects|Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11279417|NCT02795780|FG001|Participant Flow|MCI Subjects|Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
11279418|NCT02795780|OG000|Outcome|AD Aβ+ Subjects|Amyloid positive AD subjects from the flortaucipir PET scan arm
11279419|NCT02795780|OG001|Outcome|AD Aβ- Subjects|Amyloid negative AD subjects from the flortaucipir PET scan arm
11279420|NCT02795780|OG002|Outcome|MCI Aβ+ Subjects|Amyloid positive MCI subjects from the flortaucipir PET scan arm
11279421|NCT02795780|OG003|Outcome|MCI Aβ- Subjects|Amyloid negative MCI subjects from the flortaucipir PET scan arm
11279422|NCT02795780|EG000|Reported Event|MCI Subjects|MCI subjects receiving a dose of flortaucipir
11279423|NCT02795780|EG001|Reported Event|AD Subjects|AD subjects receiving a dose of flortaucipir
11279424|NCT02795819|BG000|Baseline|Cohort 1|Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.
11279425|NCT02795819|FG000|Participant Flow|Cohort Minus 1 (-1)|Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279426|NCT02795819|FG001|Participant Flow|Cohort 1|Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279427|NCT02795819|FG002|Participant Flow|Cohort 2|Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279428|NCT02795819|FG003|Participant Flow|Cohort 3A|Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279429|NCT02795819|FG004|Participant Flow|Cohort 3B|Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279430|NCT02795819|FG005|Participant Flow|Cohort 4A|Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279431|NCT02795819|FG006|Participant Flow|Cohort 4B|Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279432|NCT02795819|OG000|Outcome|Cohort Minus 1 (-1)|Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279433|NCT02795819|OG001|Outcome|Cohort 1|Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279434|NCT02795819|OG002|Outcome|Cohort 2|Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279435|NCT02795819|OG003|Outcome|Cohort 3A|Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279436|NCT02795819|OG004|Outcome|Cohort 3B|Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279437|NCT02795819|OG005|Outcome|Cohort 4A|Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously
11279438|NCT02795819|OG006|Outcome|Cohort 4B|Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
11279439|NCT02795819|EG000|Reported Event|Cohort 1|Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.
11279440|NCT02795832|BG000|Baseline|Cohort 1 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279441|NCT02795832|BG001|Baseline|Cohort 1 - Placebo|Placebo Ointment BID
11279442|NCT02795832|BG002|Baseline|Cohort 2 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279443|NCT02795832|BG003|Baseline|Cohort 2b - Placebo|Placebo Ointment BID
11279444|NCT02795832|BG004|Baseline|Cohort 3 (ZPL-5212372)|ZPL-5212372 1% w/w OIntment BID
11279445|NCT02795832|BG005|Baseline|Cohort 3 - Placebo|Placebo Ointment BID
11279446|NCT02795832|BG006|Baseline|Total|Total of all reporting groups
11279447|NCT02795832|FG000|Participant Flow|Cohort 1 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279448|NCT02795832|FG001|Participant Flow|Cohort 1 - Placebo|Placebo Ointment BID
11279449|NCT02795832|FG002|Participant Flow|Cohort 2 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279450|NCT02795832|FG003|Participant Flow|Cohort 2b - Placebo|Placebo Ointment BID
11279451|NCT02795832|FG004|Participant Flow|Cohort 3 (ZPL-5212372)|ZPL-5212372 1% w/w OIntment BID
11279452|NCT02795832|FG005|Participant Flow|Cohort 3 - Placebo|Placebo Ointment BID
11279453|NCT02795832|OG000|Outcome|Cohort 3 (ZPL-5212372)|ZPL-5212372 1% w/w OIntment BID
11279454|NCT02795832|OG001|Outcome|Cohort 3 - Placebo|Placebo Ointment BID
11279455|NCT02795832|OG000|Outcome|Day 1 - Cohort 2 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279456|NCT02795832|OG001|Outcome|Day 7 - Cohort 2 (ZPL-5212372)|ZPL-5212372 1% w/w Ointment BID
11279457|NCT02795832|OG000|Outcome|Day17 - Cohort 2 (ZPL-32123721)|ZPL-5212372 1% w/w Ointment BID
11279458|NCT02795832|OG001|Outcome|Day 7 - Cohort 2 (ZPL-32123721)|ZPL-5212372 1% w/w Ointment BID
11279459|NCT02795832|OG000|Outcome|Day 5|ZPL-5212372 trough plasma concentrations
11279460|NCT02795832|OG001|Outcome|Day 8|ZPL-5212372 trough plasma concentrations
11279461|NCT02795832|OG002|Outcome|Day 10|ZPL-5212372 trough plasma concentrations
11279462|NCT02795832|OG003|Outcome|Day 15|ZPL-5212372 trough plasma concentrations
11279463|NCT02795832|EG000|Reported Event|Cohort 1 ZPL-5212372 10% BSA|Cohort 1 ZPL-5212372 10% BSA
11279464|NCT02795832|EG001|Reported Event|Cohort 1 ZPL-5212372 40% BSA|Cohort 1 ZPL-5212372 40% BSA
11279465|NCT02795832|EG002|Reported Event|Cohort 1 Placebo 10% BSA|Cohort 1 Placebo 10% BSA
11279466|NCT02795832|EG003|Reported Event|Cohort 1 Placebo 40% BSA|Cohort 1 Placebo 40% BSA
11279467|NCT02795832|EG004|Reported Event|Cohort 2 ZPL-5212372 10% BSA|Cohort 2 ZPL-5212372 10% BSA
11279468|NCT02795832|EG005|Reported Event|Cohort 2 ZPL-5212372 40% BSA|Cohort 2 ZPL-5212372 40% BSA
11279469|NCT02795832|EG006|Reported Event|Cohort 2 Placebo 10% BSA|Cohort 2 Placebo 10% BSA
11279470|NCT02795832|EG007|Reported Event|Cohort 2 Placebo 40% BSA|Cohort 2 Placebo 40% BSA
11279471|NCT02795832|EG008|Reported Event|Cohort 3 ZPL-5212372|Cohort 3 ZPL-5212372
11279472|NCT02795832|EG009|Reported Event|Cohort 3 Placebo|Cohort 3 Placebo
11279473|NCT02796092|BG000|Baseline|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
11279474|NCT02796092|BG001|Baseline|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
11279475|NCT02796092|BG002|Baseline|Total|Total of all reporting groups
11279476|NCT02796092|FG000|Participant Flow|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
11279477|NCT02796092|FG001|Participant Flow|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
11279478|NCT02796092|OG000|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
11279479|NCT02796092|OG001|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
11279480|NCT02796092|EG000|Reported Event|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
11279481|NCT02796092|EG001|Reported Event|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
11279482|NCT02796144|BG000|Baseline|Lorcaserin and Metformin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.~Lorcaserin: Max dose of 10 mg BID~Metformin: Max dose of 1,000 mg BID"
11279483|NCT02796144|BG001|Baseline|Lorcaserin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Lorcaserin: Max dose of 10 mg BID"
11279484|NCT02796144|BG002|Baseline|Placebo|"Matching placebos will be administered for each active drug.~Placebo: Matching placebos will be administered for each drug."
11279485|NCT02796144|BG003|Baseline|Total|Total of all reporting groups
11279486|NCT02796144|FG000|Participant Flow|Lorcaserin and Metformin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.~Lorcaserin: Max dose of 10 mg BID~Metformin: Max dose of 1,000 mg BID"
11279487|NCT02796144|FG001|Participant Flow|Lorcaserin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Lorcaserin: Max dose of 10 mg BID"
11279488|NCT02796144|FG002|Participant Flow|Placebo|"Matching placebos will be administered for each active drug.~Placebo: Matching placebos will be administered for each drug."
11279489|NCT02796144|OG000|Outcome|Lorcaserin and Metformin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.~Lorcaserin: Max dose of 10 mg BID~Metformin: Max dose of 1,000 mg BID"
11279490|NCT02796144|OG001|Outcome|Placebo|"Matching placebos will be administered for each active drug.~Placebo: Matching placebos will be administered for each drug."
11279491|NCT02796144|OG000|Outcome|Lorcaserin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Lorcaserin: Max dose of 10 mg BID"
11279492|NCT02796144|OG001|Outcome|Lorcaserin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Lorcaserin: Max dose of 10 mg BID"
11279493|NCT02796144|OG002|Outcome|Placebo|"Matching placebos will be administered for each active drug.~Placebo: Matching placebos will be administered for each drug."
11279494|NCT02796144|EG000|Reported Event|Lorcaserin and Metformin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Metformin will be administered in dosages of 500 mg with a maximum dose of 2,000 mg.~Lorcaserin: Max dose of 10 mg BID~Metformin: Max dose of 1,000 mg BID"
11279495|NCT02796144|EG001|Reported Event|Lorcaserin|"Lorcaserin will be administered in dosages of 10 mg with a maximum dose of 20 mg.~Lorcaserin: Max dose of 10 mg BID"
11279496|NCT02796144|EG002|Reported Event|Placebo|"Matching placebos will be administered for each active drug.~Placebo: Matching placebos will be administered for each drug."
11279497|NCT02796274|BG000|Baseline|LHON Patients Case Record Cohort|"Historical case record data from all LHON patients fulfilling the prospectively-defined inclusion criteria:~Age ≥ 12 years.~Onset of symptoms was dated after 1999 and was well documented (at least month of onset of symptoms is known for each eye).~At least two VA assessments were available within 5 years of onset of symptoms and prior to idebenone use.~Have a genetic diagnosis for LHON for one of the following mtDNA mutations: G11778A, G3460A, or T14484C.~Actual: 48 (with VA assessment made ≤1 year after the onset of symptoms) out of 219 patients from whom data were collected and entered into the database."
11279498|NCT02796274|FG000|Participant Flow|LHON Patients Case Record Cohort|"Historical case record data from all LHON patients fulfilling the prospectively-defined inclusion criteria:~Age ≥ 12 years.~Onset of symptoms was dated after 1999 and was well documented (at least month of onset of symptoms is known for each eye).~At least two VA assessments were available within 5 years of onset of symptoms and prior to idebenone use.~Have a genetic diagnosis for LHON for one of the following mtDNA mutations: G11778A, G3460A, or T14484C."
11279499|NCT02796274|OG000|Outcome|LHON Patients Case Record Cohort|"Historical case record data from all LHON patients fulfilling the prospectively-defined inclusion criteria:~Age ≥ 12 years.~Onset of symptoms was dated after 1999 and was well documented (at least month of onset of symptoms is known for each eye).~At least two VA assessments were available within 5 years of onset of symptoms and prior to idebenone use.~Have a genetic diagnosis for LHON for one of the following mtDNA mutations: G11778A, G3460A, or T14484C."
11279500|NCT02796274|EG000|Reported Event|LHON Patients Case Record Cohort|"Historical case record data from all LHON patients fulfilling the prospectively-defined inclusion criteria:~Age ≥ 12 years.~Onset of symptoms was dated after 1999 and was well documented (at least month of onset of symptoms is known for each eye).~At least two VA assessments were available within 5 years of onset of symptoms and prior to idebenone use.~Have a genetic diagnosis for LHON for one of the following mtDNA mutations: G11778A, G3460A, or T14484C.~Actual: 48 (with VA assessment made ≤1 year after the onset of symptoms) out of 219 patients from whom data were collected and entered into the database."
11279501|NCT02796300|BG000|Baseline|Bioflo Goup|"This group will have dialysis using the Bioflo catheter.~Bioflo Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279502|NCT02796300|BG001|Baseline|Palindrome Group|"This group will have dialysis using the Palindrome catheter.~Palindrome Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279503|NCT02796300|BG002|Baseline|Total|Total of all reporting groups
11279504|NCT02796300|FG000|Participant Flow|Bioflo Goup|"This group will have dialysis using the Bioflo catheter.~Bioflo Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279505|NCT02796300|FG001|Participant Flow|Palindrome Group|"This group will have dialysis using the Palindrome catheter.~Palindrome Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279506|NCT02796300|OG000|Outcome|Bioflo Goup|"This group will have dialysis using the Bioflo catheter.~Bioflo Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279507|NCT02796300|OG001|Outcome|Palindrome Group|"This group will have dialysis using the Palindrome catheter.~Palindrome Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279508|NCT02796300|EG000|Reported Event|Bioflo Goup|"This group will have dialysis using the Bioflo catheter.~Bioflo Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279509|NCT02796300|EG001|Reported Event|Palindrome Group|"This group will have dialysis using the Palindrome catheter.~Palindrome Dialysis Catheter: The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract."
11279510|NCT02796352|BG000|Baseline|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
11279511|NCT02796352|FG000|Participant Flow|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
11279512|NCT02796352|OG000|Outcome|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
11279513|NCT02796352|EG000|Reported Event|High Dose Bolus Interleukin-2 (HD IL2)|"High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
11279514|NCT02796560|BG000|Baseline|Brand Name Travoprost First, Then Generic|Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
11279515|NCT02796560|BG001|Baseline|Generic Travoprost First, Then Brand Name|Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
11279516|NCT02796560|BG002|Baseline|Total|Total of all reporting groups
11279517|NCT02796560|FG000|Participant Flow|Brand Name Travoprost First, Then Generic|Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
11279518|NCT02796560|FG001|Participant Flow|Generic Travoprost First, Then Brand Name|Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
11279519|NCT02796560|OG000|Outcome|Brand Name Travoprost|Participants who received Brand Name Travoprost one drop once daily in either the first or last 3 weeks of the study.
11279520|NCT02796560|OG001|Outcome|Generic Travoprost|Participants who received Generic Travoprost one drop once daily in either the first or last 3 weeks of the study.
11279521|NCT02796560|EG000|Reported Event|Brand Name Travoprost|Participants received Brand Name Travoprost one drop once daily for 3 weeks.
11279522|NCT02796560|EG001|Reported Event|Generic Travoprost|Participants received Generic Travoprost one drop once daily for 3 weeks.
11279523|NCT02796625|BG000|Baseline|Painful Stimuli|"Participants will be exposed to painful heat~Painful Stimuli: warm or painful heat administration"
11279524|NCT02796625|FG000|Participant Flow|Painful Stimuli|"Participants will be exposed to painful heat~Painful Stimuli: warm or painful heat administration"
11279525|NCT02796625|OG000|Outcome|Painful Stimuli|"Participants will be exposed to painful heat~Painful Stimuli: warm or painful heat administration"
11279526|NCT02796625|EG000|Reported Event|Painful Stimuli|"Participants will be exposed to painful heat~Painful Stimuli: warm or painful heat administration"
11279527|NCT02796651|BG000|Baseline|Overall Study Total|"All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair DPI and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.~Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement."
11279528|NCT02796651|FG000|Participant Flow|Total Participants|"All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair dry powder inhalers (DPI) and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.~Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement."
11279529|NCT02796651|OG000|Outcome|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
11279530|NCT02796651|OG001|Outcome|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279531|NCT02796651|OG002|Outcome|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279532|NCT02796651|OG003|Outcome|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
11279533|NCT02796651|OG004|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279534|NCT02796651|OG004|Outcome|Perforomist 40 μg|Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.
11279535|NCT02796651|OG005|Outcome|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279536|NCT02796651|EG000|Reported Event|Formoterol Fumarate 6 μg|Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
11337673|NCT03590613|EG001|Reported Event|GSK2982772 60 mg|Participants were administered GSK2982772 60 mg via oral route using a 7 hours dosing interval in each TP
11279537|NCT02796651|EG001|Reported Event|Formoterol Fumarate (FF) 12 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279538|NCT02796651|EG002|Reported Event|Formoterol Fumarate (FF) 24 μg|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279539|NCT02796651|EG003|Reported Event|Perforomist 20 μg|Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
11279540|NCT02796651|EG004|Reported Event|Perforomist 40 μg|Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.
11279541|NCT02796651|EG005|Reported Event|Placebo (Lactose Monohydrate)|Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
11279542|NCT02796664|BG000|Baseline|Ginseng|Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279543|NCT02796664|BG001|Baseline|Placebo|Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279544|NCT02796664|BG002|Baseline|Total|Total of all reporting groups
11279545|NCT02796664|FG000|Participant Flow|Ginseng|Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279546|NCT02796664|FG001|Participant Flow|Placebo|Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279547|NCT02796664|OG000|Outcome|Ginseng|Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279548|NCT02796664|OG001|Outcome|Placebo|Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279549|NCT02796664|OG000|Outcome|Ginseng|Ginseng: Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279550|NCT02796664|OG001|Outcome|Placebo|Placebo: Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279551|NCT02796664|EG000|Reported Event|Ginseng|Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279552|NCT02796664|EG001|Reported Event|Placebo|Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
11279553|NCT02796677|BG000|Baseline|Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg|Randomized participants received AB 400 μg/FF 12 μg oral inhalation powder twice daily (BID) via dry powder inhaler (DPI).
10820417|NCT00057837|FG001|Participant Flow|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
11279554|NCT02796677|BG001|Baseline|AB 400 μg|Randomized participants received AB 400 μg oral inhalation powder BID via DPI.
11279555|NCT02796677|BG002|Baseline|FF 12 μg|Randomized participants received FF 12 μg oral inhalation powder BID via DPI.
11279556|NCT02796677|BG003|Baseline|Tiotropium (TIO) 18 μg|Randomized participants received TIO 18 μg oral inhalation powder in capsule BID via DPI.
11279557|NCT02796677|BG004|Baseline|Total|Total of all reporting groups
11279558|NCT02796677|FG000|Participant Flow|Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg|Randomized participants received AB 400 μg/FF 12 μg oral inhalation powder twice daily (BID) via dry powder inhaler (DPI).
11279559|NCT02796677|FG001|Participant Flow|AB 400 μg|Randomized participants received AB 400 μg oral inhalation powder BID via DPI.
11279560|NCT02796677|FG002|Participant Flow|FF 12 μg|Randomized participants received FF 12 μg oral inhalation powder BID via DPI.
11279561|NCT02796677|FG003|Participant Flow|Tiotropium (TIO) 18 μg|Randomized participants received TIO 18 μg oral inhalation powder in capsule BID via DPI.
11279562|NCT02796677|OG000|Outcome|AB/FF 400/12 μg|Randomized participants received orally AB 400 μg/FF 12 μg inhalation powder twice daily (BID) via dry powder inhaler (DPI).
11279563|NCT02796677|OG001|Outcome|AB 400 μg|Randomized participants received AB 400 μg oral inhalation powder BID via DPI.
11279564|NCT02796677|OG002|Outcome|FF 12 μg|Randomized participants received orally FF 12 μg inhalation powder BID via DPI.
11279565|NCT02796677|OG003|Outcome|TIO 18 μg|Edit Randomized participants received orally TIO 18 μg inhalation powder in capsule BID via DPI.
11279566|NCT02796677|OG000|Outcome|AB 400 μg|Randomized participants received orally AB 400 μg/FF 12 μg inhalation powder twice daily (BID) via dry powder inhaler (DPI).
11279567|NCT02796677|OG001|Outcome|TIO 18 μg|Randomized participants received orally TIO 18 μg inhalation powder in capsule BID via DPI.
11279568|NCT02796677|EG000|Reported Event|AB/FF 400/12 μg|Randomized participants received orally AB 400 μg/FF 12 μg inhalation powder twice daily (BID) via dry powder inhaler (DPI).
11279569|NCT02796677|EG001|Reported Event|AB 400 μg|Randomized participants received AB 400 μg oral inhalation powder BID via DPI.
11279570|NCT02796677|EG002|Reported Event|FF 12 μg|Randomized participants received orally FF 12 μg inhalation powder BID via DPI.
11279571|NCT02796677|EG003|Reported Event|TIO 18 μg|Randomized participants received orally TIO 18 μg inhalation powder in capsule BID via DPI.
11279572|NCT02796755|BG000|Baseline|Riluzole Arm|Participants took a daily oral dose of 100 mg of riluzole (50 mg two times per day) for 8 weeks. Participants were instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279573|NCT02796755|BG001|Baseline|Placebo Arm|Participants took a daily oral dose of 100 mg of a placebo that appears identical to riluzole (50 mg two times per day), for 8 weeks. Participants will be instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279574|NCT02796755|BG002|Baseline|Total|Total of all reporting groups
11279575|NCT02796755|FG000|Participant Flow|Riluzole Arm|Participants took a daily oral dose of 100 mg of riluzole (50 mg two times per day) for 8 weeks. Participants were instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11337674|NCT03590613|EG002|Reported Event|GSK2982772 120 mg|Participants were administered GSK2982772 120 mg via oral route using a 7 hours dosing interval in each TP
11279576|NCT02796755|FG001|Participant Flow|Placebo Arm|Participants took a daily oral dose of 100 mg of a placebo that appears identical to riluzole (50 mg two times per day), for 8 weeks. Participants will be instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279577|NCT02796755|OG000|Outcome|Riluzole Arm|Participants took a daily oral dose of 100 mg of riluzole (50 mg two times per day) for 8 weeks. Participants were instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279578|NCT02796755|OG001|Outcome|Placebo Arm|Participants took a daily oral dose of 100 mg of a placebo that appears identical to riluzole (50 mg two times per day), for 8 weeks. Participants will be instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279579|NCT02796755|EG000|Reported Event|Riluzole Arm|Participants took a daily oral dose of 100 mg of riluzole (50 mg two times per day) for 8 weeks. Participants were instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279580|NCT02796755|EG001|Reported Event|Placebo Arm|Participants took a daily oral dose of 100 mg of a placebo that appears identical to riluzole (50 mg two times per day), for 8 weeks. Participants will be instructed to take the study medication on an empty stomach (1 hour before or 2 hours after meals).
11279581|NCT02796924|BG000|Baseline|Patients|"30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine.~MagStim Rapid2 Transcranial Magnetic Simulation: A non-invasive method of brain stimulation"
11279582|NCT02796924|FG000|Participant Flow|Patients|"30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine.~MagStim Rapid2 Transcranial Magnetic Simulation: A non-invasive method of brain stimulation"
11279583|NCT02796924|OG000|Outcome|Patients|"30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine.~MagStim Rapid2 Transcranial Magnetic Simulation: A non-invasive method of brain stimulation"
11279584|NCT02796924|EG000|Reported Event|Patients|"30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine.~MagStim Rapid2 Transcranial Magnetic Simulation: A non-invasive method of brain stimulation"
11279585|NCT02796963|BG000|Baseline|Immediate Intervention|Guangzhou and Yantai city. Intervention in months 1-3: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
11279586|NCT02796963|BG001|Baseline|Delayed Intervention 1|Jiangmen and Jinan city. Intervention in months 4-6: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
11279587|NCT02796963|BG002|Baseline|Delayed Intervention 2|Zhuhai and Qingdao city. Intervention in months 7-9: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
11279588|NCT02796963|BG003|Baseline|Delayed Intervention 3|Shenzhen and Jining city. Intervention in months 10-12: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities.
11279589|NCT02796963|BG004|Baseline|Total|Total of all reporting groups
11279590|NCT02796963|FG000|Participant Flow|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279591|NCT02796963|FG001|Participant Flow|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279592|NCT02796963|FG002|Participant Flow|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279593|NCT02796963|FG003|Participant Flow|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279594|NCT02796963|OG000|Outcome|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11337675|NCT03590613|EG003|Reported Event|GSK2982772 240 mg|Participants were administered GSK2982772 240 mg via oral route using a 7 hours dosing interval in each TP
11279595|NCT02796963|OG001|Outcome|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279596|NCT02796963|OG002|Outcome|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279597|NCT02796963|OG003|Outcome|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities."
11279598|NCT02796963|EG000|Reported Event|Immediate Intervention|"Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
11279599|NCT02796963|EG001|Reported Event|Delayed Intervention 1|"Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
11279600|NCT02796963|EG002|Reported Event|Delayed Intervention 2|"Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
11279601|NCT02796963|EG003|Reported Event|Delayed Intervention 3|"Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12.~Crowdsourced intervention: The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.~No adverse outcome was reported."
11279602|NCT02797054|BG000|Baseline|Tailored Intervention|"Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11279603|NCT02797054|BG001|Baseline|Untailored Intervention|"Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11279604|NCT02797054|BG002|Baseline|Usual Care|"Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Usual care: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11279605|NCT02797054|BG003|Baseline|Total|Total of all reporting groups
11279606|NCT02797054|FG000|Participant Flow|Tailored Intervention|"Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11279607|NCT02797054|FG001|Participant Flow|Untailored Intervention|"Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11279608|NCT02797054|FG002|Participant Flow|Usual Care|"Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Usual care: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11279609|NCT02797054|OG000|Outcome|Tailored Intervention|"Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11279610|NCT02797054|OG001|Outcome|Untailored Intervention|"Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11279611|NCT02797054|OG002|Outcome|Usual Care|"Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Usual care: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11279612|NCT02797054|EG000|Reported Event|Tailored Intervention|"Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
11279613|NCT02797054|EG001|Reported Event|Untailored Intervention|"Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
11279614|NCT02797054|EG002|Reported Event|Usual Care|"Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Usual care: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
11279615|NCT02797080|BG000|Baseline|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
11279616|NCT02797080|FG000|Participant Flow|Interferon γ-1b|Subcutaneous (SC) ACTIMMUNE® 3 times a week (TIW) at an individualized dose.
11279617|NCT02797080|OG000|Outcome|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
11279618|NCT02797080|EG000|Reported Event|Interferon γ-1b|SC ACTIMMUNE® TIW at an individualized dose
11279619|NCT02797132|BG000|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A (<14 kg): Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 15 days in Part A.~Part A (>=14 kg): Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 15 days in Part A.~Part B (<14 kg): Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.~Part B (>=14 kg): Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 24 weeks in Part B."
11279620|NCT02797132|FG000|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A (<14 kg): Participants weighing less than (<) 14 kilograms (kg) at screening received LUM 100 milligram (mg)/IVA 125 mg fixed-dose combination every 12 hours for 15 days in Part A.~Part A (>=14 kg): Participants weighing greater than or equal to (>=) 14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 15 days in Part A.~Part B (<14 kg): Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.~Part B (>=14 kg): Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 24 weeks in Part B."
11279621|NCT02797132|OG000|Outcome|Part A (<14 kg Weight): LUM 100 mg/IVA 125 mg|Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 15 days in Part A.
11279622|NCT02797132|OG001|Outcome|Part A (>=14 kg Weight): LUM 150 mg/IVA 188 mg|Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 15 days in Part A.
11279623|NCT02797132|OG000|Outcome|Part B (<14 kg Weight): LUM 100 mg/IVA 125 mg|Participants weighing <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11279624|NCT02797132|OG001|Outcome|Part B (>=14 kg Weight): LUM 150 mg/IVA 188 mg|Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11279625|NCT02797132|OG000|Outcome|Part B (<14 kg Weight): LUM 100 mg/IVA 125 mg|Participants weighing less than 14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11279626|NCT02797132|OG000|Outcome|Part B: LUM 100 mg/IVA 125 mg|Participants weighing less than <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11279627|NCT02797132|OG001|Outcome|Part B: LUM 150 mg/IVA 188 mg|Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11337676|NCT03591068|BG000|Baseline|OPN-375 186 mcg BID|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11279628|NCT02797132|EG000|Reported Event|Part A: LUM 100 mg/IVA 125 mg|Participants weighing <14 kg at screening received LUM 100 milligram (mg)/IVA 125 mg fixed-dose combination every 12 hours for 15 days in Part A.
11279629|NCT02797132|EG001|Reported Event|Part A: LUM 150 mg/IVA 188 mg|Participants weighing >= 14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hours for 15 days in Part A.
11279630|NCT02797132|EG002|Reported Event|Part B: LUM 100 mg/IVA 125 mg|Participants weighing less than <14 kg at screening received LUM 100 mg/IVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.
11279631|NCT02797132|EG003|Reported Event|Part B: LUM 150 mg/IVA 188 mg|Participants weighing >=14 kg at screening received LUM 150 mg/IVA 188 mg fixed-dose combination every 12 hurs for 24 weeks in Part B.
11279632|NCT02797171|BG000|Baseline|Group 1: Vaccine|VRC01 10 mg/kg mo(0,2,4,6)
11279633|NCT02797171|BG001|Baseline|Group 2: Vaccine|VRC01 30 mg/kg mo(0,2,4,6)
11279634|NCT02797171|BG002|Baseline|Group 3: Vaccine|VRC01LS 30 mg/kg mo(0,3,6)
11279635|NCT02797171|BG003|Baseline|Group 4: Vaccine|VRC01 30 mg/kg mo(0)
11279636|NCT02797171|BG004|Baseline|Group 5: Vaccine|VRC01LS 30 mg/kg mo(0)
11279637|NCT02797171|BG005|Baseline|Group 6: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11279638|NCT02797171|BG006|Baseline|Total|Total of all reporting groups
11279639|NCT02797171|FG000|Participant Flow|Group 1: Vaccine|VRC01 10 mg/kg mo(0,2,4,6)
11279640|NCT02797171|FG001|Participant Flow|Group 2: Vaccine|VRC01 30 mg/kg mo(0,2,4,6)
11279641|NCT02797171|FG002|Participant Flow|Group 3: Vaccine|VRC01LS 30 mg/kg mo(0,3,6)
11279642|NCT02797171|FG003|Participant Flow|Group 4: Vaccine|VRC01 30 mg/kg mo(0)
11279643|NCT02797171|FG004|Participant Flow|Group 5: Vaccine|VRC01LS 30 mg/kg mo(0)
11279644|NCT02797171|FG005|Participant Flow|Group 6: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11279645|NCT02797171|OG000|Outcome|Group 1: Vaccine|VRC01 10 mg/kg mo(0,2,4,6)
11279646|NCT02797171|OG001|Outcome|Group 2: Vaccine|VRC01 30 mg/kg mo(0,2,4,6)
11279647|NCT02797171|OG002|Outcome|Group 3: Vaccine|VRC01LS 30 mg/kg mo(0,3,6)
11279648|NCT02797171|OG003|Outcome|Group 4: Vaccine|VRC01 30 mg/kg mo(0)
11279649|NCT02797171|OG004|Outcome|Group 5: Vaccine|VRC01LS 30 mg/kg mo(0)
11279650|NCT02797171|OG005|Outcome|Group 6: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11279651|NCT02797171|EG000|Reported Event|Group 1: Vaccine|VRC01 10 mg/kg mo(0,2,4,6)
11279652|NCT02797171|EG001|Reported Event|Group 2: Vaccine|VRC01 30 mg/kg mo(0,2,4,6)
11279653|NCT02797171|EG002|Reported Event|Group 3: Vaccine|VRC01LS 30 mg/kg mo(0,3,6)
11279654|NCT02797171|EG003|Reported Event|Group 4: Vaccine|VRC01 30 mg/kg mo(0)
11279655|NCT02797171|EG004|Reported Event|Group 5: Vaccine|VRC01LS 30 mg/kg mo(0)
11279656|NCT02797171|EG005|Reported Event|Group 6: Pre-treatment|Biopsy collected but was not randomized to any treatment group
11279657|NCT02797522|BG000|Baseline|NHV Participants: Cohort 1|NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
11279658|NCT02797522|BG001|Baseline|NHV Participants: Cohort 2|NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
11279659|NCT02797522|BG002|Baseline|NHV Participants: Cohort 3|NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
11279660|NCT02797522|BG003|Baseline|NHV Participants: Cohort 4|NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
11279661|NCT02797522|BG004|Baseline|NHV Participants: Cohort 5|NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
11279662|NCT02797522|BG005|Baseline|NHV Participants: Cohort 6|NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
11279663|NCT02797522|BG006|Baseline|NHV Participants: Placebo|NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
11279664|NCT02797522|BG007|Baseline|CHB Participants: Cohort 3b|Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279665|NCT02797522|BG008|Baseline|CHB Participants: Cohort 4b|Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279666|NCT02797522|BG009|Baseline|CHB Participants: Cohort 3c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
11279667|NCT02797522|BG010|Baseline|CHB Participants: Cohort 4c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
11279668|NCT02797522|BG011|Baseline|Total|Total of all reporting groups
11279669|NCT02797522|FG000|Participant Flow|NHV Participants: Cohort 1|Normal healthy volunteer (NHV) participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
11279670|NCT02797522|FG001|Participant Flow|NHV Participants: Cohort 2|NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
11279671|NCT02797522|FG002|Participant Flow|NHV Participants: Cohort 3|NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
11279672|NCT02797522|FG003|Participant Flow|NHV Participants: Cohort 4|NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
11279673|NCT02797522|FG004|Participant Flow|NHV Participants: Cohort 5|NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
11279674|NCT02797522|FG005|Participant Flow|NHV Participants: Cohort 6|NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
11279675|NCT02797522|FG006|Participant Flow|NHV Participants: Placebo|NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
11337677|NCT03591068|FG000|Participant Flow|OPN-375 186 mcg BID|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11279676|NCT02797522|FG007|Participant Flow|CHB Participants: Cohort 3b|Treatment-naive participants with chronic hepatitis B (CHB) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual nucleoside analog (NUC) therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279677|NCT02797522|FG008|Participant Flow|CHB Participants: Cohort 4b|Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279678|NCT02797522|FG009|Participant Flow|CHB Participants: Cohort 3c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
11279679|NCT02797522|FG010|Participant Flow|CHB Participants: Cohort 4c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
11279680|NCT02797522|OG000|Outcome|NHV Participants: Cohort 1|NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
11279681|NCT02797522|OG001|Outcome|NHV Participants: Cohort 2|NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
11279682|NCT02797522|OG002|Outcome|NHV Participants: Cohort 3|NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
11279683|NCT02797522|OG003|Outcome|NHV Participants: Cohort 4|NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
11279684|NCT02797522|OG004|Outcome|NHV Participants: Cohort 5|NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
11279685|NCT02797522|OG005|Outcome|NHV Participants: Cohort 6|NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
11279686|NCT02797522|OG006|Outcome|NHV Participants: Placebo|NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
11279687|NCT02797522|OG000|Outcome|CHB Participants: Cohort 3b|Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279688|NCT02797522|OG001|Outcome|CHB Participants: Cohort 4b|Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279689|NCT02797522|OG002|Outcome|CHB Participants: Cohort 3c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
11279690|NCT02797522|OG003|Outcome|CHB Participants: Cohort 4c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
11279691|NCT02797522|OG007|Outcome|CHB Participants: Cohort 3b|Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279692|NCT02797522|OG008|Outcome|CHB Participants: Cohort 4b|Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279693|NCT02797522|OG009|Outcome|CHB Participants: Cohort 3c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
11279694|NCT02797522|OG010|Outcome|CHB Participants: Cohort 4c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
11279695|NCT02797522|EG000|Reported Event|NHV Participants: Cohort 1|NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
11279696|NCT02797522|EG001|Reported Event|NHV Participants: Cohort 2|NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
11279697|NCT02797522|EG002|Reported Event|NHV Participants: Cohort 3|NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
11279698|NCT02797522|EG003|Reported Event|NHV Participants: Cohort 4|NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
11279699|NCT02797522|EG004|Reported Event|NHV Participants: Cohort 5|NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
11279700|NCT02797522|EG005|Reported Event|NHV Participants: Cohort 6|NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
11279701|NCT02797522|EG006|Reported Event|NHV Participants: Placebo|NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
11279702|NCT02797522|EG007|Reported Event|CHB Participants: Cohort 3b|Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279703|NCT02797522|EG008|Reported Event|CHB Participants: Cohort 4b|Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
11279704|NCT02797522|EG009|Reported Event|CHB Participants: Cohort 3c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
11279705|NCT02797522|EG010|Reported Event|CHB Participants: Cohort 4c|Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
11337678|NCT03591068|OG000|Outcome|OPN-375 186 mcg BID|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11337679|NCT03591068|OG000|Outcome|OPN-375 186 mcg BID - Systolic BP|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11279706|NCT02797613|BG000|Baseline|Restricted Reporting|"Microbiology laboratory will report Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results~Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important"
11279707|NCT02797613|BG001|Baseline|Standard Reporting|Microbiology laboratory will report identification and susceptibility results
11279708|NCT02797613|BG002|Baseline|Total|Total of all reporting groups
11279709|NCT02797613|FG000|Participant Flow|Restricted Reporting|"Microbiology laboratory will report Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results~Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important"
11279710|NCT02797613|FG001|Participant Flow|Standard Reporting|Microbiology laboratory will report identification and susceptibility results
11279711|NCT02797613|OG000|Outcome|Restricted Reporting|"Microbiology laboratory will report Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results~Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important"
11279712|NCT02797613|OG001|Outcome|Standard Reporting|Microbiology laboratory will report identification and susceptibility results
11279713|NCT02797613|EG000|Reported Event|Restricted Reporting|"Microbiology laboratory will report Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results~Restricted Reporting: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important"
11279714|NCT02797613|EG001|Reported Event|Standard Reporting|Microbiology laboratory will report identification and susceptibility results
11279715|NCT02797678|BG000|Baseline|All Study Participants|All participants that were consented for this study are including in the baseline measures.
11279716|NCT02797678|FG000|Participant Flow|Screening Phase|This is all participants that signed consent for this study.
11092352|NCT01539291|EG002|Reported Event|Placebo+R (PD) to IDL 150 mg|Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and met the primary endpoint of PD and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11279717|NCT02797678|FG001|Participant Flow|PowerSleep Stim, PowerSleep Sham|This arm are participants that were randomized to PowerSleep Stim mode first and then PowerSleep Sham.
11279718|NCT02797678|FG002|Participant Flow|PowerSleep Sham, PowerSleep Stim|This arm are participants that were randomized to PowerSleep Sham first, and then PowerSleep Stim.
11279719|NCT02797678|FG003|Participant Flow|PowerSleep Stim - Extension Study|Those participants that completed the primary trial, participated in an extension study.
11279720|NCT02797678|OG000|Outcome|Powersleep|"Participants will wear the PowerSleep device with soft audio tones (below 65dB to prevent arousals from sleep) administered via the speakers during deep sleep throughout the night.~Powersleep: Participants will receive 5 nights of stimulation"
11279721|NCT02797678|OG001|Outcome|Sham Powersleep|"Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.~Sham Powersleep: Participants will receive 5 nights of no stimulation"
11279722|NCT02797678|OG000|Outcome|Powersleep Stim|Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
11279723|NCT02797678|OG001|Outcome|Powersleep Sham|Sham Powersleep: Participants will receive 5 nights of no stimulation
11279724|NCT02797678|OG000|Outcome|Powersleep|Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
11279725|NCT02797678|OG001|Outcome|Sham Powersleep|Sham Powersleep: Participants will receive 5 nights of no stimulation
11279726|NCT02797678|EG000|Reported Event|Screening - Non Intervention|SThe adverse events are reported on all participants that entered screening for the study until randomization visit
11279727|NCT02797678|EG001|Reported Event|PowerSleep Stim|All participants that received the PowerSleep Stim week.
11279728|NCT02797678|EG002|Reported Event|Washout|All participants that had a washout period of one to two weeks before crossing over into the other arm of the trial.
11279729|NCT02797678|EG003|Reported Event|Powersleep Sham|All participants that received the PowerSleep Sham week
11279730|NCT02797678|EG004|Reported Event|Sub-study|Completed participants were asked to participate in a sub-study with a new device configuration. Participants completed 5 nights of use.
11279731|NCT02797808|BG000|Baseline|Obsessive-compulsive Disorder|Sertraline: Impact of sertraline on functional brain connectivity
11279732|NCT02797808|BG001|Baseline|Healthy Controls|No Intervention: Healthy control non-intervention
11279733|NCT02797808|BG002|Baseline|Total|Total of all reporting groups
11279734|NCT02797808|FG000|Participant Flow|Obsessive-compulsive Disorder|Sertraline: Impact of sertraline on functional brain connectivity
11279735|NCT02797808|FG001|Participant Flow|Healthy Controls|No Intervention: Healthy control non-intervention
11279736|NCT02797808|OG000|Outcome|Children With OCD|Sertraline: Impact of sertraline on functional brain connectivity
11279737|NCT02797808|OG001|Outcome|Healthy Control Children|No Intervention: Healthy control non-intervention
11279738|NCT02797808|EG000|Reported Event|Obsessive-compulsive Disorder|Sertraline: Impact of sertraline on functional brain connectivity
11279739|NCT02797808|EG001|Reported Event|Healthy Controls|No Intervention: Healthy control non-intervention
11279740|NCT02797821|BG000|Baseline|Asfotase Alfa 0.5 mg/kg Dose|Participants received 0.5 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279741|NCT02797821|BG001|Baseline|Asfotase Alfa 2.0 mg/kg Dose|Participants received 2.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279742|NCT02797821|BG002|Baseline|Asfotase Alfa 3.0 mg/kg Dose|Participants received 3.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279743|NCT02797821|BG003|Baseline|Total|Total of all reporting groups
11279744|NCT02797821|FG000|Participant Flow|Asfotase Alfa 0.5 mg/kg Dose|Participants received 0.5 milligrams (mg) per kilogram (kg) of asfotase alfa administered subcutaneously (SC) 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279745|NCT02797821|FG001|Participant Flow|Asfotase Alfa 2.0 mg/kg Dose|Participants received 2.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279746|NCT02797821|FG002|Participant Flow|Asfotase Alfa 3.0 mg/kg Dose|Participants received 3.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279747|NCT02797821|OG000|Outcome|Asfotase Alfa 0.5 mg/kg Dose|Participants received 0.5 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279748|NCT02797821|OG001|Outcome|Asfotase Alfa 2.0 mg/kg Dose|Participants received 2.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279749|NCT02797821|OG002|Outcome|Asfotase Alfa 3.0 mg/kg Dose|Participants received 3.0 mg/kg of asfotase alfa administered SC 3 times a week from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279750|NCT02797821|EG000|Reported Event|Asfotase Alfa 0.5 mg/kg Dose|Participants received 0.5 mg/kg of asfotase alfa administered SC 3 times a week (1 dose each on Mondays, Wednesdays, and Fridays) from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279751|NCT02797821|EG001|Reported Event|Asfotase Alfa 2.0 mg/kg Dose|Participants received 2.0 mg/kg of asfotase alfa administered SC 3 times a week (1 dose each on Mondays, Wednesdays, and Fridays) from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279752|NCT02797821|EG002|Reported Event|Asfotase Alfa 3.0 mg/kg Dose|Participants received 3.0 mg/kg of asfotase alfa administered SC 3 times a week (1 dose each on Mondays, Wednesdays, and Fridays) from Weeks 3 through 9 following the initial single dose on Day 1 in Week 1.
11279753|NCT02798211|BG000|Baseline|Group 1|secukinumab 300mg s.c. injection
11279754|NCT02798211|BG001|Baseline|Group 2|secukinumab 150 mg s.c. injection
11279755|NCT02798211|BG002|Baseline|Group 3|Placebo s.c. injection
11279756|NCT02798211|BG003|Baseline|Total|Total of all reporting groups
11279757|NCT02798211|FG000|Participant Flow|Group 1|secukinumab 300mg s.c. injection
11279758|NCT02798211|FG001|Participant Flow|Group 2|secukinumab 150 mg s.c. injection
11279759|NCT02798211|FG002|Participant Flow|Group 3|Placebo s.c. injection
11279760|NCT02798211|FG003|Participant Flow|Group 4|Secukinumab 150 mg - 150 mg (R)
11279761|NCT02798211|FG004|Participant Flow|Group 5|Secukinumab 150 mg - 300 mg (NR)
11279762|NCT02798211|FG005|Participant Flow|Group 6|Placebo - Secukinumab 300 mg
11279763|NCT02798211|OG000|Outcome|Group 1|secukinumab 300mg s.c. injection
11279764|NCT02798211|OG001|Outcome|Group 2|secukinumab 150 mg s.c. injection
11279765|NCT02798211|OG002|Outcome|Group 3|Placebo s.c. injection
11279766|NCT02798211|OG001|Outcome|Group 2|secukinumab 150 mg s.c. injection (R) Responders
11279767|NCT02798211|OG002|Outcome|Group 3|secukinumab 150 mg s.c. injection (NR) Non-responders
11279768|NCT02798211|OG003|Outcome|Group 4|Any Secukinumab 150mg
11279769|NCT02798211|OG004|Outcome|Group 5|Placebo s.c. injection 300mg
11279770|NCT02798211|EG000|Reported Event|Secukinumab 300mg|Secukinumab 300mg
11279771|NCT02798211|EG001|Reported Event|Secukinumab 150mg|Secukinumab 150mg
11279772|NCT02798211|EG002|Reported Event|Placebo|Placebo
11279773|NCT02798289|BG000|Baseline|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
11279774|NCT02798289|FG000|Participant Flow|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
11279775|NCT02798289|OG000|Outcome|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
11279776|NCT02798289|EG000|Reported Event|Active - Device|The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
11279777|NCT02798315|BG000|Baseline|Participants With HCV Genotype 1 or 4|Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
11279778|NCT02798315|FG000|Participant Flow|Participants With Hepatitis C Virus (HCV) Genotype 1 or 4|Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV).
11279779|NCT02798315|OG000|Outcome|Participants With HCV Genotype 1 or 4|Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
11279780|NCT02798315|EG000|Reported Event|Participants With HCV Genotype 1 or 4|Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.
11287058|NCT02896595|BG001|Baseline|General Anesthesia With Laryngeal Mask Airway|"Patients assigned to the LMA group will have LMA placed in a standard fashion by anesthesia provider. LMA size will be decided based on patient characteristics and at the discretion of attending anesthesiologist. LMA used will be LMA Supreme (Teleflex Medicals, Ireland). Once placed auscultation will be used to ensure correct placement of LMA.~General Anesthesia with laryngeal mask airway: Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287059|NCT02896595|BG002|Baseline|Total|Total of all reporting groups
11279781|NCT02798354|BG000|Baseline|Reduce Elevated Blood Pressure Errors|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.
11279782|NCT02798354|BG001|Baseline|Reduce Depression Errors|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.
11279783|NCT02798354|BG002|Baseline|Reduce Lab Related Errors|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.
11279784|NCT02798354|BG003|Baseline|Total|Total of all reporting groups
11279785|NCT02798354|FG000|Participant Flow|Group 1: Blood Pressure, Depresion, Labs|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.
11279786|NCT02798354|FG001|Participant Flow|Group 2: Depression, Labs, Blood Pressure|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.
11279787|NCT02798354|FG002|Participant Flow|Group 3: Labs, Blood Pressure, Depression|A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.
11279788|NCT02798354|OG000|Outcome|Control Group|Patients included at all practices during practices' depression control phase
11279789|NCT02798354|OG001|Outcome|Intervention Group|Patients included at all practices during pratices' depression intervention phase
11279790|NCT02798354|OG000|Outcome|Control Group|Patients included at all practices during practices' BP control phase
11092353|NCT01539291|EG003|Reported Event|Placebo+R to IDL 150 mg|Adverse events reported in this group occurred during the extension Study GS-US-312-0117 in participants who received placebo tablet twice daily plus rituximab (8 infusions intravenously) in Study GS-US-312-0116 and entered Study GS-US-312-0117 to receive IDL 150 mg tablet twice daily.
11092354|NCT01539317|BG000|Baseline|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11279791|NCT02798354|OG001|Outcome|Intervention Group|Patients included at all practices during practices' BP intervention phase
11279792|NCT02798354|OG000|Outcome|Control Group|Patients included at all practices during practices' Labs control phase
11279793|NCT02798354|OG001|Outcome|Intervention Group|Patients included at all practices during practices' Labs intervention phase
11279794|NCT02798354|OG000|Outcome|Intervention Group|Patients included at all practices during practices' Labs intervention phase
11279795|NCT02798354|OG000|Outcome|Intervention Group|Patients included at all practices during practices' BP intervention phase
11279796|NCT02798354|OG000|Outcome|Intervention Group|Patients included at all practices during pratices' depression intervention phase
11337680|NCT03591068|OG001|Outcome|OPN-375 186 mcg BID - Diastolic BP|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11337681|NCT03591068|EG000|Reported Event|OPN-375 186 mcg BID|Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
11337682|NCT03591146|BG000|Baseline|TLC590 190mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11279797|NCT02798354|EG000|Reported Event|Reduce Elevated Blood Pressure Errors|"Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Each group provides control data and intervention data on all 3 errors in different sequences. Three Wave 2 practices were recruited to increase power and they intervened on only 2 errors.~Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinar"
11279798|NCT02798354|EG001|Reported Event|Reduce Depression Errors|"Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis.~Each group provides control data and intervention data on all 3 errors in different sequences. Two Wave 2 practices were recruited to increase power and they intervened on only 2 errors.~Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams cons"
11279799|NCT02798354|EG002|Reported Event|Reduce Lab Related Errors|"Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis. Each group provides control data and intervention data on all 3 errors in different sequences. Four Wave 2 practices were recruited to increase power and they intervened on only 2 errors.~Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at ea"
11279800|NCT02798380|BG000|Baseline|HTS-519 Insert|"Active treatment~HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail"
11279801|NCT02798380|FG000|Participant Flow|HTS-519 Insert|"Active treatment~HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail"
11279802|NCT02798380|OG000|Outcome|Safety Population: All Enrolled|"Active treatment~HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail"
11279803|NCT02798380|EG000|Reported Event|HTS-519 Insert|"Active treatment~HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail"
11279804|NCT02798627|BG000|Baseline|NS2359|"The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity."
11279805|NCT02798627|BG001|Baseline|Placebo|"Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~placebo: Placebo pills identical in appearance to the NS2359 will be provided"
11279806|NCT02798627|BG002|Baseline|Total|Total of all reporting groups
11279807|NCT02798627|FG000|Participant Flow|NS2359|"The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity."
11279808|NCT02798627|FG001|Participant Flow|Placebo|"Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~placebo: Placebo pills identical in appearance to the NS2359 will be provided"
11279809|NCT02798627|OG000|Outcome|NS2359|"The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity."
11279810|NCT02798627|OG001|Outcome|Placebo|"Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~placebo: Placebo pills identical in appearance to the NS2359 will be provided"
11279811|NCT02798627|EG000|Reported Event|NS2359|"The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity."
11279812|NCT02798627|EG001|Reported Event|Placebo|"Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.~placebo: Placebo pills identical in appearance to the NS2359 will be provided"
11279813|NCT02798835|BG000|Baseline|Adductor Canal Block|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.~Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279814|NCT02798835|BG001|Baseline|Adductor Canal Block With Dexamethasone|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.~Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.~Dexamethasone: To be given intravenously at time of nerve block to one of the study arms."
11279815|NCT02798835|BG002|Baseline|Adductor Canal Catheter|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.~Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279816|NCT02798835|BG003|Baseline|Total|Total of all reporting groups
11279817|NCT02798835|FG000|Participant Flow|Adductor Canal Block|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.~Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279818|NCT02798835|FG001|Participant Flow|Adductor Canal Block With Dexamethasone|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.~Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.~Dexamethasone: To be given intravenously at time of nerve block to one of the study arms."
11279819|NCT02798835|FG002|Participant Flow|Adductor Canal Catheter|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.~Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279820|NCT02798835|OG000|Outcome|Adductor Canal Block|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.~Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279821|NCT02798835|OG001|Outcome|Adductor Canal Block With Dexamethasone|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.~Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.~Dexamethasone: To be given intravenously at time of nerve block to one of the study arms."
11279822|NCT02798835|OG002|Outcome|Adductor Canal Catheter|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.~Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
10820418|NCT00057837|OG000|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
11279823|NCT02798835|EG000|Reported Event|Adductor Canal Block|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.~Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279824|NCT02798835|EG001|Reported Event|Adductor Canal Block With Dexamethasone|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.~Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.~Dexamethasone: To be given intravenously at time of nerve block to one of the study arms."
11279825|NCT02798835|EG002|Reported Event|Adductor Canal Catheter|"Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.~Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.~Bupivacaine: Used in spinal anesthetic~Fentanyl: May or may not be used in spinal anesthetic~Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block."
11279826|NCT02798861|BG000|Baseline|CAP Assessment|"Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes~Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient."
11279827|NCT02798861|FG000|Participant Flow|Allografts|Livers assessed before procurement and after implantation.
11279828|NCT02798861|OG000|Outcome|CAP Assessment|"Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes~Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient."
11279829|NCT02798861|EG000|Reported Event|CAP Assessment|"Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes~Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient."
11279830|NCT02798952|BG000|Baseline|Engerix-B Kinder Group|Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
11279831|NCT02798952|FG000|Participant Flow|Engerix-B Kinder Group|Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
11279832|NCT02798952|OG000|Outcome|Engerix-B Kinder Group|Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
11279833|NCT02798952|EG000|Reported Event|Engerix-B Kinder Group|Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
11279834|NCT02798978|BG000|Baseline|Part 1: Placebo|Participants in Part 1 were randomized to receive intravenous (IV) matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
11279835|NCT02798978|BG001|Baseline|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5.
11279836|NCT02798978|BG002|Baseline|Part 1: GSK1795091 21 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
11279837|NCT02798978|BG003|Baseline|Part 1: GSK1795091 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
11279838|NCT02798978|BG004|Baseline|Part 1: GSK1795091 Repeated 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
11279839|NCT02798978|BG005|Baseline|Part 1: GSK1795091 100 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
11279840|NCT02798978|BG006|Baseline|All Participants in Part 2|In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
11279841|NCT02798978|BG007|Baseline|Total|Total of all reporting groups
11279842|NCT02798978|FG000|Participant Flow|Part 1: Placebo|Participants in Part 1 were randomized to receive intravenous (IV) matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
11279843|NCT02798978|FG001|Participant Flow|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5.
11279844|NCT02798978|FG002|Participant Flow|Part 1: GSK1795091 21 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
11279845|NCT02798978|FG003|Participant Flow|Part 1: GSK1795091 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
11279846|NCT02798978|FG004|Participant Flow|Part 1: GSK1795091 Repeated 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
11279847|NCT02798978|FG005|Participant Flow|Part 1: GSK1795091 100 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
11279848|NCT02798978|FG006|Participant Flow|All Participants in Part 2|In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
11279849|NCT02798978|OG000|Outcome|Part 1: Placebo|Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
11279850|NCT02798978|OG001|Outcome|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
11279851|NCT02798978|OG002|Outcome|Part 1: GSK1795091 21 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
11279852|NCT02798978|OG003|Outcome|Part 1: GSK1795091 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
11279853|NCT02798978|OG004|Outcome|Part 1: GSK1795091 Repeated 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
11279854|NCT02798978|OG005|Outcome|Part 1: GSK1795091 100 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
11279855|NCT02798978|OG001|Outcome|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5.
11279856|NCT02798978|OG000|Outcome|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
11279857|NCT02798978|OG001|Outcome|Part 1: GSK1795091 21 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
11279858|NCT02798978|OG002|Outcome|Part 1: GSK1795091 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
11279859|NCT02798978|OG003|Outcome|Part 1: GSK1795091 Repeated 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
11092355|NCT01539317|BG001|Baseline|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11279860|NCT02798978|OG004|Outcome|Part 1: GSK1795091 100 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
11279861|NCT02798978|OG000|Outcome|All Participants in Part 2|In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
11279862|NCT02798978|EG000|Reported Event|Part 1: Placebo|Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
11279863|NCT02798978|EG001|Reported Event|Part 1: GSK1795091 7 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
11279864|NCT02798978|EG002|Reported Event|Part 1: GSK1795091 21 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
11279865|NCT02798978|EG003|Reported Event|Part 1: GSK1795091 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
11279866|NCT02798978|EG004|Reported Event|Part 1: GSK1795091 Repeated 60 ng|In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
11279867|NCT02798978|EG005|Reported Event|Part 1: GSK1795091 100 ng|In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
11279868|NCT02798978|EG006|Reported Event|All Participants in Part 2|In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
11279869|NCT02799069|BG000|Baseline|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279870|NCT02799069|BG001|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11092356|NCT01539317|BG002|Baseline|Total|Total of all reporting groups
11279871|NCT02799069|BG002|Baseline|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279872|NCT02799069|BG003|Baseline|Total|Total of all reporting groups
11279873|NCT02799069|FG000|Participant Flow|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279874|NCT02799069|FG001|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279875|NCT02799069|FG002|Participant Flow|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279876|NCT02799069|OG000|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279877|NCT02799069|OG001|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279878|NCT02799069|OG002|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279879|NCT02799069|EG000|Reported Event|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279880|NCT02799069|EG001|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279881|NCT02799069|EG002|Reported Event|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
11279882|NCT02799082|BG000|Baseline|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
10820419|NCT00057837|OG001|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
11279883|NCT02799082|BG001|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
10820420|NCT00057837|EG000|Reported Event|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
11279884|NCT02799082|BG002|Baseline|Total|Total of all reporting groups
11279885|NCT02799082|FG000|Participant Flow|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279886|NCT02799082|FG001|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279887|NCT02799082|OG000|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279888|NCT02799082|OG001|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279889|NCT02799082|EG000|Reported Event|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279890|NCT02799082|EG001|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
11279891|NCT02799290|BG000|Baseline|CONTROL|No intervention
11279892|NCT02799290|BG001|Baseline|ADIPOSE TISSUE EXTRACT|"Adipose Tissue extract application~ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration"
11279893|NCT02799290|BG002|Baseline|PLATELET-RICH PLASMA GEL|"PLATELET RICH PLASMA GEL APPLICATION~PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions"
11279894|NCT02799290|BG003|Baseline|Total|Total of all reporting groups
11279895|NCT02799290|FG000|Participant Flow|CONTROL|No treatment
11279896|NCT02799290|FG001|Participant Flow|ADIPOSE TISSUE EXTRACT|"Adipose Tissue extract application~ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration"
11279897|NCT02799290|FG002|Participant Flow|PLATELET-RICH PLASMA GEL|"PLATELET RICH PLASMA GEL APPLICATION~PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions"
11279898|NCT02799290|OG000|Outcome|CONTROL|No treatment
11279899|NCT02799290|OG001|Outcome|ADIPOSE TISSUE EXTRACT|"Adipose Tissue extract application~ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration"
11279900|NCT02799290|OG002|Outcome|PLATELET-RICH PLASMA GEL|"PLATELET RICH PLASMA GEL APPLICATION~PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions"
11279901|NCT02799290|OG000|Outcome|CONTROL ATE|No treatment
11279902|NCT02799290|OG003|Outcome|CONTROL PRP|No treatment
11279903|NCT02799290|OG003|Outcome|CONTROL PRP|no treatment
11092357|NCT01539317|FG000|Participant Flow|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11279904|NCT02799290|OG003|Outcome|PRP Control|no treatment
11092358|NCT01539317|FG001|Participant Flow|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11279905|NCT02799290|EG000|Reported Event|CONTROL|No treatment
11279906|NCT02799290|EG001|Reported Event|ADIPOSE TISSUE EXTRACT|"Adipose Tissue extract application~ADIPOSE TISSUE EXTRACT: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration"
11279907|NCT02799290|EG002|Reported Event|PLATELET-RICH PLASMA GEL|"PLATELET RICH PLASMA GEL APPLICATION~PLATELET-RICH PLASMA GEL: Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions"
11279908|NCT02799381|BG000|Baseline|Optimized Medical Treatment (OMT)|Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
11279909|NCT02799381|BG001|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
11279910|NCT02799381|BG002|Baseline|Total|Total of all reporting groups
11279911|NCT02799381|FG000|Participant Flow|Optimized Medical Treatment (OMT)|Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
11279912|NCT02799381|FG001|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
11279913|NCT02799381|OG000|Outcome|Optimized Medical Treatment (OMT)|Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
11279914|NCT02799381|OG001|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
11279915|NCT02799381|EG000|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
11279916|NCT02799381|EG001|Reported Event|Optimized Medical Treatment (OMT)|Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
11279917|NCT02799472|BG000|Baseline|Placebo|Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5-25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279918|NCT02799472|BG001|Baseline|GSK3196165 180 mg|Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5-5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279919|NCT02799472|BG002|Baseline|Total|Total of all reporting groups
11279920|NCT02799472|FG000|Participant Flow|Placebo|Eligible participants received matching placebo subcutaneously (SC) into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received methotrexate (MTX) 7.5-25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279921|NCT02799472|FG001|Participant Flow|GSK3196165 180 mg|Eligible participants received GSK3196165 180 milligrams (mg) SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5-5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279922|NCT02799472|OG000|Outcome|Placebo|Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5-25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279923|NCT02799472|OG001|Outcome|GSK3196165 180 mg|Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5-5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279924|NCT02799472|EG000|Reported Event|Placebo|Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5-25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279925|NCT02799472|EG001|Reported Event|GSK3196165 180 mg|Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5-5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
11279926|NCT02799667|BG000|Baseline|Standard Dressing|"Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.~Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure."
11279927|NCT02799667|BG001|Baseline|Negative Pressure Wound Therapy Dressing|"Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.~Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure."
11279928|NCT02799667|BG002|Baseline|Total|Total of all reporting groups
11279929|NCT02799667|FG000|Participant Flow|Standard Dressing|"Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.~Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure."
11279930|NCT02799667|FG001|Participant Flow|Negative Pressure Wound Therapy Dressing|"Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.~Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure."
11279931|NCT02799667|OG000|Outcome|Standard Dressing|"Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.~Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure."
11279932|NCT02799667|OG001|Outcome|Negative Pressure Wound Therapy Dressing|"Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.~Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure."
11279933|NCT02799667|EG000|Reported Event|Standard Dressing|"Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.~Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure."
11279934|NCT02799667|EG001|Reported Event|Negative Pressure Wound Therapy Dressing|"Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.~Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure."
11279935|NCT02799745|BG000|Baseline|Enzalutamide|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-mg enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279936|NCT02799745|BG001|Baseline|Active Surveillance|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279937|NCT02799745|BG002|Baseline|Total|Total of all reporting groups
11279938|NCT02799745|FG000|Participant Flow|Enzalutamide|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-miligram (mg) enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279939|NCT02799745|FG001|Participant Flow|Active Surveillance|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued active surveillance (AS) for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279940|NCT02799745|OG000|Outcome|Enzalutamide|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-mg enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279941|NCT02799745|OG001|Outcome|Active Surveillance|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279942|NCT02799745|EG000|Reported Event|Enzalutamide|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-mg enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279943|NCT02799745|EG001|Reported Event|Active Surveillance|The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months).
11279944|NCT02799784|BG000|Baseline|All Treatment Combined|In this 2-way crossover study, eligible participants were randomized to receive UMEC/VI inhalation powder 62.5/25 mcg QD administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler in 8-week TP1 and TP2 per randomization. This was separated by a 3-week washout period. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11092359|NCT01539317|OG000|Outcome|Topical Saline|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
11092360|NCT01539317|OG001|Outcome|Topical Liquid Lidocaine|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
11279945|NCT02799784|FG000|Participant Flow|UMEC/VI Followed by TIO/OLO|In this 2-way crossover study, eligible participants were administered Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 microgram (mcg) (as one inhalation) once-daily (QD) via ELLIPTA Inhaler for 8 weeks in TP1. It was followed by a washout period of 3 weeks. Par. received Tiotropium/Olodaterol (TIO/OLO) 5/5 mcg inhalation spray as 2 inhalations of 2.5/2.5 mcg each via the RESPIMAT® inhaler for 8 weeks in TP2. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279946|NCT02799784|FG001|Participant Flow|TIO/OLO Followed by UMEC/VI|In this 2-way crossover study, eligible participants were administered TIO/OLO 5/5 mcg inhalation spray as 2 inhalations of 2.5/2.5 mcg each via the RESPIMAT® inhaler for 8 weeks in TP1. It was followed by a washout period of 3 weeks. Par. received UMEC/VI 62.5/25 mcg (as one inhalation) QD via ELLIPTA Inhaler for 8 weeks in TP2. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279947|NCT02799784|OG000|Outcome|Umeclidinium/Vilanterol 62.5/25 mcg|Eligible par. were administered Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg (as one inhalation) once-daily (QD) via the ELLIPTA Inhaler for 8 weeks followed by a washout period of 3 weeks in period-1 or 2 as per randomization. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279948|NCT02799784|OG001|Outcome|Tiotropium/Olodaterol 5/5 mcg|Eligible par. were administered Tiotropium/Olodaterol (TIO/OLO) 5/5 mcg inhalation spray as 2 inhalations of 2.5/2.5 mcg each via the RESPIMAT® inhaler for 8 weeks followed by a washout period of 3 weeks in period-1 or 2 as per randomization. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279949|NCT02799784|EG000|Reported Event|Umeclidinium/Vilanterol 62.5/25 mcg|Eligible par. were administered Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg (as one inhalation) once-daily (QD) via the ELLIPTA Inhaler for 8 weeks followed by a washout period of 3 weeks in period-1 or 2 as per randomization. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279950|NCT02799784|EG001|Reported Event|Tiotropium/Olodaterol 5/5 mcg|Eligible par. were administered Tiotropium/Olodaterol (TIO/OLO) 5/5 mcg inhalation spray as 2 inhalations of 2.5/2.5 mcg each via the RESPIMAT® inhaler for 8 weeks followed by a washout period of 3 weeks in period-1 or 2 as per randomization. Albuterol/salbutamol was supplied as an inhalation spray via metered dose inhaler throughout the study for use as-needed
11279951|NCT02800148|BG000|Baseline|Azelaic Acid Foam|Azelaic acid foam
11279952|NCT02800148|BG001|Baseline|Finacea Foam|Azelaic acid foam
11279953|NCT02800148|BG002|Baseline|Placebo Foam|Azelaic acid foam - Placebo
11279954|NCT02800148|BG003|Baseline|Total|Total of all reporting groups
11279955|NCT02800148|FG000|Participant Flow|Azelaic Acid Foam|Azelaic acid foam
11092361|NCT01539317|OG002|Outcome|Open Label|"During Open-label Lidocaine 8 weeks~Each prior arm converted to use of open label lidocaine for 2 further months."
11092362|NCT01539317|OG000|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11092363|NCT01539317|OG001|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11279956|NCT02800148|FG001|Participant Flow|Finacea Foam|Azelaic acid foam
11279957|NCT02800148|FG002|Participant Flow|Placebo Foam|Azelaic acid foam - Placebo
11279958|NCT02800148|OG000|Outcome|Azelaic Acid Foam|Azelaic acid foam
11279959|NCT02800148|OG001|Outcome|Finacea Foam|Azelaic acid foam
11279960|NCT02800148|OG002|Outcome|Placebo Foam|Azelaic acid foam - Placebo
11279961|NCT02800148|EG000|Reported Event|Azelaic Acid Foam|Azelaic acid foam
11279962|NCT02800148|EG001|Reported Event|Finacea Foam|Azelaic acid foam
11279963|NCT02800148|EG002|Reported Event|Placebo Foam|Azelaic acid foam - Placebo
11279964|NCT02800213|BG000|Baseline|Modified Then Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
11279965|NCT02800213|BG001|Baseline|Conventional Then Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
11279966|NCT02800213|BG002|Baseline|Total|Total of all reporting groups
11279967|NCT02800213|FG000|Participant Flow|Modified Then Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
11279968|NCT02800213|FG001|Participant Flow|Conventional Then Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
11279969|NCT02800213|OG000|Outcome|Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
11279970|NCT02800213|OG001|Outcome|Conventional Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
11279971|NCT02800213|EG000|Reported Event|Modified Ambu Spur II Bag Valve Mask|"A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.~After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask."
11279972|NCT02800213|EG001|Reported Event|Conventional Ambu Spur II Bag Valve Mask|"A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).~Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.~After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask."
11279973|NCT02800356|BG000|Baseline|Pseudodrusen|Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
11279974|NCT02800356|FG000|Participant Flow|Pseudodrusen|Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
11279975|NCT02800356|OG000|Outcome|Pseudodrusen|Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
11279976|NCT02800356|EG000|Reported Event|Pseudodrusen|Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
11279977|NCT02800642|BG000|Baseline|Intravitreal (IVT) Aflibercept|Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
11279978|NCT02800642|FG000|Participant Flow|Intravitreal (IVT) Aflibercept|Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
11279979|NCT02800642|OG000|Outcome|Intravitreal (IVT) Aflibercept|Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
11279980|NCT02800642|EG000|Reported Event|Intravitreal (IVT) Aflibercept|Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
11279981|NCT02800928|BG000|Baseline|All Study Participants|"Administered orally once daily, 10mg daily, 8 days~CERC-501: CERC-501~7 day wash-out~Administered orally once daily, placebo~Order of placebo/CERC-501 counterbalanced"
11279982|NCT02800928|FG000|Participant Flow|Treatment First|"Administered orally once daily, 10mg daily, 8 days~CERC-501: CERC-501~7 day wash-out~Administered orally once daily, placebo, 8 days~Order of placebo/CERC-501 counterbalanced"
11279983|NCT02800928|FG001|Participant Flow|Placebo First|"Administered orally once daily, placebo, 8 days FIRST~7 day wash-out~Administered orally once daily, CERC-501: CERC-501 10mg daily, 8 days SECOND"
11279984|NCT02800928|OG000|Outcome|CERC-501|"Administered orally once daily, 10mg daily, 8 days~CERC-501: CERC-501"
11279985|NCT02800928|OG001|Outcome|Placebo|"Administered orally daily, 8 days~Placebo: Placebo"
11279986|NCT02800928|EG000|Reported Event|CERC-501|"Administered orally once daily, 10mg daily, 8 days~CERC-501: CERC-501"
11279987|NCT02800928|EG001|Reported Event|Placebo|"Administered orally daily, 8 days~Placebo: Placebo"
11279988|NCT02801006|BG000|Baseline|Overall Study|Total participants enrolled
11279989|NCT02801006|FG000|Participant Flow|Stenfilcon A First, Then Etafilcon A|Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.
11279990|NCT02801006|FG001|Participant Flow|Etafilcon A First, Then Stenfilcon A|Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.
11279991|NCT02801006|OG000|Outcome|Stenfilcon A|"Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study.~stenfilcon A: contact lens"
11279992|NCT02801006|OG001|Outcome|Etafilcon A Toric|"Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
11279993|NCT02801006|OG001|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first or second) for two weeks during the cross over study.~etafilcon A: contact lens"
11279994|NCT02801006|OG001|Outcome|Etafilcon A|"Participants randomized to wear etafilcon A toric lens pair (either first of second) for two weeks during the cross over study.~etafilcon A: contact lens"
11279995|NCT02801006|EG000|Reported Event|Stenfilcon A|Participants randomized to wear stenfilcon A lens pair either as first or second pair in this crossover study.
11279996|NCT02801006|EG001|Reported Event|Etafilcon A|Participants randomized to wear etafilcon A lens pair either as first or second pair in this crossover study.
11279997|NCT02801370|BG000|Baseline|12 mg OTO-201|12 mg ciprofloxacin: single administration
11279998|NCT02801370|BG001|Baseline|Control|Sham Control: Simulated, single administration
11279999|NCT02801370|BG002|Baseline|Total|Total of all reporting groups
11280000|NCT02801370|FG000|Participant Flow|12 mg OTO-201|12 mg ciprofloxacin: single administration
11280001|NCT02801370|FG001|Participant Flow|Control|Sham Control: Simulated, single adminstration
11280002|NCT02801370|OG000|Outcome|12 mg OTO-201|12 mg ciprofloxacin: single administration
11280003|NCT02801370|OG001|Outcome|Control|Sham Control: Simulated, single adminstration
11280004|NCT02801370|OG001|Outcome|Control|Sham control: Simulated, single administration
11280005|NCT02801370|EG000|Reported Event|12 mg OTO-201|12 mg ciprofloxacin: single administration
11280006|NCT02801370|EG001|Reported Event|Control|Sham Control: Simulated, single administration
11280007|NCT02801396|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11280008|NCT02801396|FG000|Participant Flow|Test1/Test2/Control|Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
11280009|NCT02801396|FG001|Participant Flow|Test1/Control/Test2|Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
11280010|NCT02801396|FG002|Participant Flow|Test2/Test1/Control|Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
11280011|NCT02801396|FG003|Participant Flow|Test2/Control/Test1|Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
11280012|NCT02801396|FG004|Participant Flow|Control/Test1/Test2|Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
11280013|NCT02801396|FG005|Participant Flow|Control/Test2/Test1|Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
11280014|NCT02801396|OG000|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
11280015|NCT02801396|OG001|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
11280016|NCT02801396|OG002|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
11280017|NCT02801396|EG000|Reported Event|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
11280018|NCT02801396|EG001|Reported Event|Test2|Subjects that wore the Test 2 lens during any of the 3 periods.
11280019|NCT02801396|EG002|Reported Event|Control|Subjects that wore the control lens during any of the 3 study periods.
11280020|NCT02801578|BG000|Baseline|Ibrutinib|"Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.~During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.~Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule)."
11092364|NCT01539317|EG000|Reported Event|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11280021|NCT02801578|FG000|Participant Flow|Ibrutinib|"Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.~During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.~Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule)."
11280022|NCT02801578|OG000|Outcome|Ibrutinib|"Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.~During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.~Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule)."
11280023|NCT02801578|EG000|Reported Event|Ibrutinib|"Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.~During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.~Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule)."
11280024|NCT02801617|BG000|Baseline|Sequence 1 (PRO-067)|"60 study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.~Washout period: 21 hours~PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.~GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication."
11280025|NCT02801617|BG001|Baseline|Sequence 2 (GAAP Ofteno®)|"60 study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.~Washout period: 21 hours~PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.~GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication."
11280026|NCT02801617|BG002|Baseline|Total|Total of all reporting groups
11280027|NCT02801617|FG000|Participant Flow|Sequence 1 (PRO-067)|"study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.~Washout period: 21 hours~PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.~GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication."
11280028|NCT02801617|FG001|Participant Flow|Sequence 2 (GAAP Ofteno®)|"study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.~Washout period: 21 hours~PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.~GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication."
11280029|NCT02801617|OG000|Outcome|Sequence A (PRO-067- GAAP Ofteno®)|"First Period. PRO-067: 1 drop QD (per day) during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.~Second period. GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication."
11280030|NCT02801617|OG001|Outcome|Sequence B (GAAP Ofteno® - PRO-067)|"Fist Period. GAAP Ofteno®: 1 drop QD (per day) during 30 days Active comparator, reference medication.~Second Period. PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V."
11280031|NCT02801617|OG000|Outcome|PRO-067|PRO-067,QD (per day) for 60 days. Includes both periods of PRO-067 in sequence A and B.
11280032|NCT02801617|OG001|Outcome|GAAP Ofteno®|GAAP Ofteno® QD (per day) for 60 days. Includes both periods of GAAP in sequence A and B.
11280033|NCT02801617|OG000|Outcome|Sequence 1 (PRO-067)|"Study subjects will be allocated to receive:~PRO-067: 1 drop QD (per day) during 30 days after GAAP Ofteno®: 1 drop QD during 30 days"
11280034|NCT02801617|OG001|Outcome|Sequence 2 (GAAP Ofteno®)|"Study subjects will be allocated to receive:~GAAP Ofteno®: 1 drop QD (per day) during 30 days after PRO-067: 1 drop QD during 30 days"
11280035|NCT02801617|EG000|Reported Event|PRO-067|PRO-067,QD for 60 days. Includes both periods of PRO-067 in sequence A and B.
11280036|NCT02801617|EG001|Reported Event|GAAP Ofteno®|GAAP Ofteno®, QD for 60 days. Includes both periods of PRO-067 in sequence A and B.
11280037|NCT02801669|BG000|Baseline|DU-176b 15 mg|Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.
11280038|NCT02801669|BG001|Baseline|Placebo|Participants who were randomized to oral placebo administered once daily.
11280039|NCT02801669|BG002|Baseline|Total|Total of all reporting groups
11280040|NCT02801669|FG000|Participant Flow|DU-176b 15 mg|Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.
11280041|NCT02801669|FG001|Participant Flow|Placebo|Participants who were randomized to oral placebo administered once daily.
11280042|NCT02801669|OG000|Outcome|DU-176b 15 mg|Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.
11280043|NCT02801669|OG001|Outcome|Placebo|Participants who were randomized to oral placebo administered once daily.
11280044|NCT02801669|EG000|Reported Event|DU-176b 15 mg|Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.
11092365|NCT01539317|EG001|Reported Event|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
11280045|NCT02801669|EG001|Reported Event|Placebo|Participants who were randomized to oral placebo administered once daily.
11280046|NCT02801877|BG000|Baseline|IntelliCare Hub Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Hub App with the Recommender System~Coaching"
11280047|NCT02801877|BG001|Baseline|IntelliCare Hub Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare~Hub App with the Recommender System"
11280048|NCT02801877|BG002|Baseline|IntelliCare Hub no Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Coaching"
11280049|NCT02801877|BG003|Baseline|IntelliCare Hub no Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare"
11280050|NCT02801877|BG004|Baseline|Total|Total of all reporting groups
11280051|NCT02801877|FG000|Participant Flow|IntelliCare Hub Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Hub App with the Recommender System~Coaching"
11280052|NCT02801877|FG001|Participant Flow|IntelliCare Hub Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare~Hub App with the Recommender System"
11280053|NCT02801877|FG002|Participant Flow|IntelliCare Hub no Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Coaching"
11280054|NCT02801877|FG003|Participant Flow|IntelliCare Hub no Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare"
11280055|NCT02801877|OG000|Outcome|IntelliCare Hub Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Hub App with the Recommender System~Coaching"
11280056|NCT02801877|OG001|Outcome|IntelliCare Hub Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare~Hub App with the Recommender System"
11280057|NCT02801877|OG002|Outcome|IntelliCare Hub no Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Coaching"
11280058|NCT02801877|OG003|Outcome|IntelliCare Hub no Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare"
11280059|NCT02801877|EG000|Reported Event|IntelliCare Hub Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Hub App with the Recommender System~Coaching"
11280060|NCT02801877|EG001|Reported Event|IntelliCare Hub Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare~Hub App with the Recommender System"
11280061|NCT02801877|EG002|Reported Event|IntelliCare Hub no Recommender, Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.~IntelliCare~Coaching"
11280062|NCT02801877|EG003|Reported Event|IntelliCare Hub no Recommender, no Coach|"Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.~IntelliCare"
11280063|NCT02801942|BG000|Baseline|Healthy Participants|Participants were considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin, International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count were within the normal range at screening.
11280064|NCT02801942|BG001|Baseline|Participants With NOT1D|NOT1D participants with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, were included in the study.
11280065|NCT02801942|BG002|Baseline|Total|Total of all reporting groups
11280066|NCT02801942|FG000|Participant Flow|Healthy Participants|Participants were considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin, International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count were within the normal range at screening.
11280067|NCT02801942|FG001|Participant Flow|Participants With NOT1D|NOT1D participants with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, were included in the study.
11280068|NCT02801942|OG000|Outcome|Healthy Participants|Participants were considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin, International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count were within the normal range at screening.
11280069|NCT02801942|OG001|Outcome|Participants With NOT1D|NOT1D participants with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, were included in the study.
11280070|NCT02801942|EG000|Reported Event|Healthy Participants|Participants were considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin, International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count were within the normal range at screening.
11280071|NCT02801942|EG001|Reported Event|Participants With NOT1D|NOT1D participants with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, were included in the study.
11280072|NCT02802111|BG000|Baseline|Albuterol 5 mg First, Then Levalbuterol 2.5 mg|"Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention."
11280073|NCT02802111|BG001|Baseline|Levalbuterol 2.5 mg First, Then Albuterol 5 mg|"Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention"
11280074|NCT02802111|BG002|Baseline|Total|Total of all reporting groups
11280075|NCT02802111|FG000|Participant Flow|Albuterol 5 mg First, Then Levalbuterol 2.5 mg|"Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention."
11280076|NCT02802111|FG001|Participant Flow|Levalbuterol 2.5 mg First, Then Albuterol 5 mg|"Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention"
11280077|NCT02802111|OG000|Outcome|Albuterol 5 mg First, Then Levalbuterol 2.5 mg|"Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention."
11280078|NCT02802111|OG001|Outcome|Levalbuterol 2.5 mg First, Then Albuterol 5 mg|"Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.~Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention"
11280079|NCT02802111|EG000|Reported Event|Albuterol 5 mg First, Then Levalbuterol 2.5 mg|"Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Patients are observed for adverse events for 4 hours after second medication.~Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention."
11280080|NCT02802111|EG001|Reported Event|Levalbuterol 2.5 mg First, Then Albuterol 5 mg|"Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Patients are observed for adverse events for 4 hours after second medication.~Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention"
11280081|NCT02802241|BG000|Baseline|Open-label Placebo|placebo
11280082|NCT02802241|BG001|Baseline|Double-blind Placebo|placebo
11280083|NCT02802241|BG002|Baseline|Double-blind Peppermint Oil|peppermint oil
11280084|NCT02802241|BG003|Baseline|no Pill Control|control
11280085|NCT02802241|BG004|Baseline|Total|Total of all reporting groups
11280086|NCT02802241|FG000|Participant Flow|Open-label Placebo|placebo
11280087|NCT02802241|FG001|Participant Flow|Double-blind Placebo|placebo
11280088|NCT02802241|FG002|Participant Flow|Double-blind Peppermint Oil|peppermint oil
11280089|NCT02802241|FG003|Participant Flow|no Pill Control|control
11280090|NCT02802241|OG000|Outcome|Open-label Placebo|placebo
11280091|NCT02802241|OG001|Outcome|Double-blind Placebo|placebo
11280092|NCT02802241|OG002|Outcome|Double-blind Peppermint Oil|peppermint oil
11280093|NCT02802241|OG003|Outcome|no Pill Control|control
11280094|NCT02802241|EG000|Reported Event|Open-label Placebo|placebo
11280095|NCT02802241|EG001|Reported Event|Double-blind Placebo|placebo
11280096|NCT02802241|EG002|Reported Event|Double-blind Peppermint Oil|peppermint oil
11280097|NCT02802241|EG003|Reported Event|no Pill Control|control
11280098|NCT02802319|BG000|Baseline|Test: Porcine Xenograft (Zcore)|"Ridge preservation bone grafting surgery with porcine xenograft (Zcore)~Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction"
11280099|NCT02802319|BG001|Baseline|Active Control: Bovine Xenograft (Bio-Oss)|"Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)~Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction"
11280100|NCT02802319|BG002|Baseline|Total|Total of all reporting groups
11280101|NCT02802319|FG000|Participant Flow|Test: Porcine Xenograft (Zcore)|"Ridge preservation bone grafting surgery with porcine xenograft (Zcore)~Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction"
11280102|NCT02802319|FG001|Participant Flow|Active Control: Bovine Xenograft (Bio-Oss)|"Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)~Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction"
11280103|NCT02802319|OG000|Outcome|Test: Porcine Xenograft (Zcore)|"Ridge preservation bone grafting surgery with porcine xenograft (Zcore)~Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction"
11280104|NCT02802319|OG001|Outcome|Active Control: Bovine Xenograft (Bio-Oss)|"Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)~Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction"
11280105|NCT02802319|EG000|Reported Event|Test: Porcine Xenograft (Zcore)|"Ridge preservation bone grafting surgery with porcine xenograft (Zcore)~Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction"
11280106|NCT02802319|EG001|Reported Event|Active Control: Bovine Xenograft (Bio-Oss)|"Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)~Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction"
11287060|NCT02896595|FG000|Participant Flow|General Anesthesia With Endotracheal Tube|"Patients assigned to the ETT tube group will have ETT placed in the safest manner deemed appropriate by attending anesthesiologist. Possible ways to have ETT placed will be using direct laryngoscopy, glidescope or fiberoptic intubations. Size of ETT will be decided based on patient characteristics and discretion of attending anesthesiologist. Once placed, auscultation and capnography will be used to ensure correct placement of ETT.~General Anesthesia with endotracheal tube: Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287061|NCT02896595|FG001|Participant Flow|General Anesthesia With Laryngeal Mask Airway|"Patients assigned to the LMA group will have LMA placed in a standard fashion by anesthesia provider. LMA size will be decided based on patient characteristics and at the discretion of attending anesthesiologist. LMA used will be LMA Supreme (Teleflex Medicals, Ireland). Once placed auscultation will be used to ensure correct placement of LMA.~General Anesthesia with laryngeal mask airway: Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287062|NCT02896595|OG000|Outcome|General Anesthesia With Endotracheal Tube|"Patients assigned to the ETT tube group will have ETT placed in the safest manner deemed appropriate by attending anesthesiologist. Possible ways to have ETT placed will be using direct laryngoscopy, glidescope or fiberoptic intubations. Size of ETT will be decided based on patient characteristics and discretion of attending anesthesiologist. Once placed, auscultation and capnography will be used to ensure correct placement of ETT.~General Anesthesia with endotracheal tube: Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287063|NCT02896595|OG001|Outcome|General Anesthesia With Laryngeal Mask Airway|"Patients assigned to the LMA group will have LMA placed in a standard fashion by anesthesia provider. LMA size will be decided based on patient characteristics and at the discretion of attending anesthesiologist. LMA used will be LMA Supreme (Teleflex Medicals, Ireland). Once placed auscultation will be used to ensure correct placement of LMA.~General Anesthesia with laryngeal mask airway: Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287064|NCT02896595|EG000|Reported Event|General Anesthesia With Endotracheal Tube|"Patients assigned to the ETT tube group will have ETT placed in the safest manner deemed appropriate by attending anesthesiologist. Possible ways to have ETT placed will be using direct laryngoscopy, glidescope or fiberoptic intubations. Size of ETT will be decided based on patient characteristics and discretion of attending anesthesiologist. Once placed, auscultation and capnography will be used to ensure correct placement of ETT.~General Anesthesia with endotracheal tube: Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
11287065|NCT02896595|EG001|Reported Event|General Anesthesia With Laryngeal Mask Airway|"Patients assigned to the LMA group will have LMA placed in a standard fashion by anesthesia provider. LMA size will be decided based on patient characteristics and at the discretion of attending anesthesiologist. LMA used will be LMA Supreme (Teleflex Medicals, Ireland). Once placed auscultation will be used to ensure correct placement of LMA.~General Anesthesia with laryngeal mask airway: Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs."
10820421|NCT00057837|EG001|Reported Event|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
11092366|NCT01539512|BG000|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11092367|NCT01539512|BG001|Baseline|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280107|NCT02802345|BG000|Baseline|Nintedanib+Placebo|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with placebo matching to Sildenafil for 24 weeks.
11280108|NCT02802345|BG001|Baseline|Nintedanib+Sildenafil|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with 20 mg thrice daily (tid) Sildenafil for 24 weeks.
11280109|NCT02802345|BG002|Baseline|Total|Total of all reporting groups
11280110|NCT02802345|FG000|Participant Flow|Nintedanib+Placebo|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with placebo matching to Sildenafil for 24 weeks.
11280111|NCT02802345|FG001|Participant Flow|Nintedanib+Sildenafil|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with 20 mg thrice daily (tid) Sildenafil for 24 weeks.
11280112|NCT02802345|OG000|Outcome|Nintedanib+Placebo|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with placebo matching to Sildenafil for 24 weeks.
11280113|NCT02802345|OG001|Outcome|Nintedanib+Sildenafil|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with 20 mg thrice daily (tid) Sildenafil for 24 weeks.
11280114|NCT02802345|EG000|Reported Event|Nintedanib+Placebo|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with placebo matching to Sildenafil for 24 weeks.
11280115|NCT02802345|EG001|Reported Event|Nintedanib+Sildenafil|Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with 20 mg thrice daily (tid) Sildenafil for 24 weeks.
11280116|NCT02802449|BG000|Baseline|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
11280117|NCT02802449|BG001|Baseline|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
11280118|NCT02802449|BG002|Baseline|Total|Total of all reporting groups
11280119|NCT02802449|FG000|Participant Flow|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
11280120|NCT02802449|FG001|Participant Flow|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
11280121|NCT02802449|OG000|Outcome|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
11280122|NCT02802449|OG001|Outcome|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
11280123|NCT02802449|EG000|Reported Event|Placebo|"The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo"
11280124|NCT02802449|EG001|Reported Event|25 Hydroxy-Vitamin D3 or [25 (OH) D3]|"The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 [25 (OH) D3]: Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator."
11280125|NCT02802501|BG000|Baseline|DHA-PQP Only|Participants received either 3 tablets (body weight: <75 kilograms [kg]) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280126|NCT02802501|BG001|Baseline|Tafenoquine+ DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11092368|NCT01539512|BG002|Baseline|Total|Total of all reporting groups
11092369|NCT01539512|FG000|Participant Flow|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280127|NCT02802501|BG002|Baseline|Primaquine+DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280128|NCT02802501|BG003|Baseline|Total|Total of all reporting groups
11280129|NCT02802501|FG000|Participant Flow|DHA-PQP Only|Participants received either 3 tablets (body weight: <75 kilograms [kg]) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280130|NCT02802501|FG001|Participant Flow|Tafenoquine+ DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280131|NCT02802501|FG002|Participant Flow|Primaquine+DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280132|NCT02802501|OG000|Outcome|DHA-PQP Only|Participants received either 3 tablets (body weight: <75 kilograms [kg]) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280133|NCT02802501|OG001|Outcome|Tafenoquine+ DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280134|NCT02802501|OG000|Outcome|Tafenoquine+ DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280135|NCT02802501|OG001|Outcome|Primaquine+DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280136|NCT02802501|OG002|Outcome|Primaquine+DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280137|NCT02802501|EG000|Reported Event|DHA-PQP Only|Participants received either 3 tablets (body weight: <75 kilograms [kg]) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280138|NCT02802501|EG001|Reported Event|Tafenoquine+ DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280139|NCT02802501|EG002|Reported Event|Primaquine+DHA-PQP|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11092370|NCT01539512|FG001|Participant Flow|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280140|NCT02802501|EG003|Reported Event|DHA-PQP Only (Open-label Primaquine Phase)|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280141|NCT02802501|EG004|Reported Event|Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase)|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280142|NCT02802501|EG005|Reported Event|Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase)|Participants received either 3 tablets (body weight: <75 kg) or 4 tablets (body weight: >=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine 15 mg once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
11280143|NCT02802514|BG000|Baseline|All Participants|Participants received albiglutide 50 mg or exenatide 10 µg along with matching placebo post off-therapy MRI in a cross-over manner in Session 1 and 2. There was a wash-out period of 6-9 weeks between the two sessions.
11280144|NCT02802514|FG000|Participant Flow|Session 1 Off-therapy MRI+Albiglutide Followed by Session 2|Participants underwent off-therapy MRI on Day 1 then received albiglutide 50 mg on Day 5 followed by exenatide matching placebo on Day 8 during Session 1. Post-dose MRI was conducted following exenatide placebo on Day 8 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants received albiglutide matching placebo on Day 1 followed by 10 µg of exenatide on Day 4. Post-dose MRI was conducted following exenatide dose on Day 4 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280145|NCT02802514|FG001|Participant Flow|Session 1 Off-therapy MRI+Exenatide Followed by Session 2|Participants underwent off-therapy MRI on Day 1 then received albiglutide matching placebo on Day 5 followed by 10 µg of exenatide on Day 8 during Session 1. Post-dose MRI was conducted following exenatide dose on Day 8 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants received albiglutide 50 mg on Day 1 followed by exenatide matching placebo on Day 4. Post-dose MRI was conducted following exenatide matching placebo dose on Day 4 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280146|NCT02802514|FG002|Participant Flow|Session1 Albiglutide Followed by Session2Off-therapy+Exenatide|Participants received albiglutide 50 mg on Day 1 followed by exenatide matching placebo on Day 4 during Session 1. Post-dose MRI was conducted following exenatide placebo on Day 4 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants underwent off-therapy MRI on Day 1 then received albiglutide matching placebo on Day 5 followed by 10 µg of exenatide on Day 8. Post-dose MRI was conducted following exenatide dose on Day 8 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280147|NCT02802514|FG003|Participant Flow|Session 1 Exenatide Followed by Session2 Off-therapy+Exenatide|Participants received albiglutide matching placebo on Day 1 followed by 10 µg of exenatide on Day 4 during Session 1. Post-dose MRI was conducted following exenatide dose on Day 4 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants underwent off-therapy MRI on Day 1 then received albiglutide 50 mg on Day 5 followed by exenatide matching placebo on Day 8. Post-dose MRI was conducted following exenatide matching placebo dose on Day 8 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280148|NCT02802514|OG000|Outcome|Albiglutide 50 mg|Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.
11280149|NCT02802514|OG001|Outcome|Exenatide 10 µg|Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.
11280150|NCT02802514|OG002|Outcome|Off-therapy MRI|Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.
11280151|NCT02802514|OG002|Outcome|Off-therapy MRI Arm|Participants underwent single off-therapy MRI on Day 1 of session 1 or session 2 as per randomization schedule. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans. Participants did not undergo MRI on off-therapy visit on Day 5.
11280152|NCT02802514|OG003|Outcome|Off-therapy Visit|Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
11280153|NCT02802514|OG002|Outcome|Albiglutide Matching Placebo|Participants in Session 1 received albiglutide matching placebo on Day 1 or Day 5 and during Session 2 participants received albiglutide matching placebo on Day 5 or Day 1. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280154|NCT02802514|OG003|Outcome|Exenatide Matching Placebo|Participants in Session 1 received exenatide matching placebo on Day 4 or Day 8 and during Session 2 participants received exenatide matching placebo on Day 8 or Day 4. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
11280155|NCT02802514|EG000|Reported Event|Albiglutide 50 mg|Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.
11280156|NCT02802514|EG001|Reported Event|Exenatide 10 µg|Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.
11280157|NCT02802514|EG002|Reported Event|Albiglutide Matching Placebo|Participants in Session 1 received albiglutide matching placebo on Day 1 and during Session 2 participants received albiglutide matching placebo on Day 5. There was a wash-out period of 6-9 weeks between the two sessions.
11280158|NCT02802514|EG003|Reported Event|Exenatide Matching Placebo|Participants in Session 1 received exenatide matching placebo on Day 4 and during Session 2 participants received exenatide matching placebo on Day 8. There was a wash-out period of 6-9 weeks between the two sessions.
11280159|NCT02802735|BG000|Baseline|Part 1: Apremilast|Participants received a single oral dose of 20 mg apremilast, 30 mg apremilast, and 40 mg apremilast across 3 treatment periods separated by a washout period of 7-10 days.
11280160|NCT02802735|BG001|Baseline|Part 2: Apremilast 30 mg BID|Participants received 30 mg apremilast orally twice a day for 14 days.
11280161|NCT02802735|BG002|Baseline|Part 2: Placebo BID|Participants received matching placebo orally twice a day for 14 days.
11280162|NCT02802735|BG003|Baseline|Total|Total of all reporting groups
11280163|NCT02802735|FG000|Participant Flow|Part 1: Apremilast 20 mg / 30 mg / 40 mg|Participants received a single oral dose of 20 mg apremilast on day 1 of period 1, a single oral dose of 30 mg apremilast on day 1 of period 2, and a single oral dose of 40 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.
11280164|NCT02802735|FG001|Participant Flow|Part 1: Apremilast 30 mg / 20 mg / 40 mg|Participants received a single oral dose of 30 mg apremilast on day 1 of period 1, a single oral dose of 20 mg apremilast on day 1 of period 2, and a single oral dose of 40 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.
11280165|NCT02802735|FG002|Participant Flow|Part 1: Apremilast 40 mg / 20 mg / 30 mg|Participants received a single oral dose of 40 mg apremilast on day 1 of period 1, a single oral dose of 20 mg apremilast on day 1 of period 2, and a single oral dose of 30 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.
11280166|NCT02802735|FG003|Participant Flow|Part 2: Apremilast 30 mg BID|Participants received 30 mg apremilast orally twice a day for 14 days.
11280167|NCT02802735|FG004|Participant Flow|Part 2: Placebo BID|Participants received matching placebo orally twice a day for 14 days.
11280168|NCT02802735|OG000|Outcome|Part 1: Apremilast 20 mg|Participants received a single oral dose of 20 mg apremilast.
11280169|NCT02802735|OG001|Outcome|Part 1: Apremilast 30 mg|Participants received a single oral dose of 30 mg apremilast.
11280170|NCT02802735|OG002|Outcome|Part 1: Apremilast 40 mg|Participants received a single oral dose of 40 mg apremilast.
11280171|NCT02802735|OG000|Outcome|Part 2: Apremilast 30 mg BID|Participants received 30 mg apremilast orally twice a day (BID) for 14 days.
11280172|NCT02802735|OG003|Outcome|Part 2: Apremilast 30 mg BID|Participants received 30 mg apremilast orally twice a day for 14 days.
10820422|NCT00057863|BG000|Baseline|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
11092371|NCT01539512|OG000|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280173|NCT02802735|OG004|Outcome|Part 2: Placebo BID|Participants received matching placebo orally twice a day for 14 days.
11280174|NCT02802735|EG000|Reported Event|Part 1: Apremilast 20 mg|Participants received a single oral dose of 20 mg apremilast.
11280175|NCT02802735|EG001|Reported Event|Part 1: Apremilast 30 mg|Participants received a single oral dose of 30 mg apremilast.
11280176|NCT02802735|EG002|Reported Event|Part 1: Apremilast 40 mg|Participants received a single oral dose of 40 mg apremilast.
11280177|NCT02802735|EG003|Reported Event|Part 1: Total|Participants received a single oral dose of 20 mg apremilast, 30 mg apremilast, and 40 mg apremilast across 3 treatment periods separated by a washout period of 7-10 days.
11280178|NCT02802735|EG004|Reported Event|Part 2: Apremilast 30 mg BID|Participants received 30 mg apremilast orally twice a day for 14 days.
11280179|NCT02802735|EG005|Reported Event|Part 2: Placebo BID|Participants received matching placebo orally twice a day for 14 days.
11280180|NCT02802735|EG006|Reported Event|Part 2: Total|Participants who received 30 mg apremilast or placebo twice a day for 14 days
11280181|NCT02802865|BG000|Baseline|Letrozole|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7~Letrozole"
11280182|NCT02802865|BG001|Baseline|Letrozole + Clomiphene|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7~Clomiphene~Letrozole"
11280183|NCT02802865|BG002|Baseline|Total|Total of all reporting groups
11280184|NCT02802865|FG000|Participant Flow|Letrozole|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7~Letrozole"
11280185|NCT02802865|FG001|Participant Flow|Letrozole + Clomiphene|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7~Clomiphene~Letrozole"
11280186|NCT02802865|OG000|Outcome|Letrozole|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7~Letrozole"
11280187|NCT02802865|OG001|Outcome|Letrozole + Clomiphene|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7~Clomiphene~Letrozole"
11280188|NCT02802865|EG000|Reported Event|Letrozole|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7~Letrozole"
11280189|NCT02802865|EG001|Reported Event|Letrozole + Clomiphene|"Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7~Clomiphene~Letrozole"
11280190|NCT02802878|BG000|Baseline|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
11280191|NCT02802878|BG001|Baseline|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
11280192|NCT02802878|BG002|Baseline|Total|Total of all reporting groups
11092372|NCT01539512|OG001|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280193|NCT02802878|FG000|Participant Flow|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
11280194|NCT02802878|FG001|Participant Flow|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
11280195|NCT02802878|OG000|Outcome|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
11280196|NCT02802878|OG001|Outcome|Low Intensity Exercise|Isokinetic Training with isokinetic dynamometer. Low intensity exercises completed in isokinetic mode at approximately 40%1 RM in same repetitions/sets as experimental group.
11280197|NCT02802878|EG000|Reported Event|Hybrid Training|"The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.~Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
11280198|NCT02802878|EG001|Reported Event|Low Intensity Exercise|"40% max isokinetic training in same repetitions/sets as experimental group.~Isokinetic Training with Computer Sports Medicine Inc. (CSMi) HUMAC NORM: Low intensity exercises completed using CSMi HUMAC NORM in isokinetic mode at approximately 40%1 RM."
11280199|NCT02803138|BG000|Baseline|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
11280200|NCT02803138|FG000|Participant Flow|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
11280201|NCT02803138|OG000|Outcome|Participants With HCV Genotype 1 or 4|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
11280202|NCT02803138|EG000|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily) up to 24 weeks
11280203|NCT02803138|EG001|Reported Event|Ombitasvir/Paritaprevir/Ritonavir|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks
11280204|NCT02803138|EG002|Reported Event|Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin|Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
11280205|NCT02803164|BG000|Baseline|Intervention|"Treatment of wound with Vacuum-assisted dressing.~Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing."
11280206|NCT02803164|BG001|Baseline|Control Group|Historical chest wound treatment.
11280207|NCT02803164|BG002|Baseline|Total|Total of all reporting groups
11280208|NCT02803164|FG000|Participant Flow|Intervention|"Treatment of wound with Vacuum-assisted dressing.~Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing."
11280209|NCT02803164|FG001|Participant Flow|Historical Control|Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques
11280210|NCT02803164|OG000|Outcome|Intervention|"Treatment of wound with Vacuum-assisted dressing.~Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing."
11280211|NCT02803164|OG001|Outcome|Historical Control|Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
11280212|NCT02803164|OG000|Outcome|Vacuum-assisted Dressing|"Eligible subjects will receive negative pressure wound therapy during surgery.~Wound Vacuum-assisted dressing: The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit)."
11280213|NCT02803164|OG001|Outcome|Historical Control Group for Comparison|"Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.~Control group: Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques."
11280214|NCT02803164|EG000|Reported Event|Intervention|"Treatment of wound with Vacuum-assisted dressing.~Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing."
11280215|NCT02803164|EG001|Reported Event|Historical Control|Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques
11280216|NCT02803229|BG000|Baseline|Placebo|"matched Placebo arm~Matched placebo: matched placebo provided for placebo arm"
11280217|NCT02803229|BG001|Baseline|Adderall-XR|"Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose~Adderall-XR"
11280218|NCT02803229|BG002|Baseline|Total|Total of all reporting groups
11280219|NCT02803229|FG000|Participant Flow|Placebo|"matched Placebo arm~Matched placebo: matched placebo provided for placebo arm"
11280220|NCT02803229|FG001|Participant Flow|Adderall-XR|"Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose~Adderall-XR"
11280221|NCT02803229|OG000|Outcome|Placebo|"matched Placebo arm~Matched placebo: matched placebo provided for placebo arm"
11280222|NCT02803229|OG001|Outcome|Adderall-XR|"Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose~Adderall-XR"
11280223|NCT02803229|EG000|Reported Event|Placebo|"matched Placebo arm~Matched placebo: matched placebo provided for placebo arm"
11280224|NCT02803229|EG001|Reported Event|Adderall-XR|"Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose~Adderall-XR"
11280225|NCT02803580|BG000|Baseline|Participants With Idiopathic Pulmonary Fibrosis|Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
11280226|NCT02803580|FG000|Participant Flow|Participants With Idiopathic Pulmonary Fibrosis|Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
11280227|NCT02803580|OG000|Outcome|Participants With Idiopathic Pulmonary Fibrosis|Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
11280228|NCT02803580|EG000|Reported Event|Participants With Idiopathic Pulmonary Fibrosis|Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months.
11280229|NCT02803749|BG000|Baseline|Buspirone|"Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.~Buspirone"
11280230|NCT02803749|BG001|Baseline|Placebo|"Flexible dosage placebo for 12 weeks.~Placebo"
11280231|NCT02803749|BG002|Baseline|Total|Total of all reporting groups
11280232|NCT02803749|FG000|Participant Flow|Buspirone|"Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.~Buspirone"
11280233|NCT02803749|FG001|Participant Flow|Placebo|"Flexible dosage placebo for 12 weeks.~Placebo"
11280234|NCT02803749|OG000|Outcome|Buspirone|"Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.~Buspirone"
11280235|NCT02803749|OG001|Outcome|Placebo|"Flexible dosage placebo for 12 weeks.~Placebo"
11280236|NCT02803749|EG000|Reported Event|Buspirone|"Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.~Buspirone"
11280237|NCT02803749|EG001|Reported Event|Placebo|"Flexible dosage placebo for 12 weeks.~Placebo"
11280238|NCT02804178|BG000|Baseline|ATR-101|Ascending dose levels of ATR-101 beginning with 125 mg by mouth twice per day up to 1000 mg twice per day.
11280239|NCT02804178|FG000|Participant Flow|ATR-101|Ascending dose levels of ATR-101 beginning with 125 mg by mouth twice per day up to 1000 mg twice per day.
11280240|NCT02804178|OG000|Outcome|ATR-101|Ascending dose levels of ATR-101 beginning with 125 mg by mouth twice per day up to 1000 mg twice per day.
11280241|NCT02804178|EG000|Reported Event|ATR-101|Ascending dose levels of ATR-101 beginning with 125 mg by mouth twice per day up to 1000 mg twice per day.
11280242|NCT02804399|BG000|Baseline|Entire Study|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.
11280243|NCT02804399|FG000|Participant Flow|PF-06463922 100 mg Single Dose (SD)|PF-06463922 was administered following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours) as 4 * 25 milligram (mg) tablets on Day 1 of Period 1. Investigator site personnel administered study medication with ambient temperature water to a total volume of approximately 240 milliliter (mL).
11280244|NCT02804399|FG001|Participant Flow|Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal from Day 1 to Day 9 of Period 2, except for rifampin dose on Day 8 of Period 2, which was administered simultaneously with PF-06463922. PF-06463922 100 mg (4 * 25 mg tablets) and rifampin were administered (rifampin followed by PF-06463922) following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours).
11280245|NCT02804399|OG000|Outcome|PF-06463922 100 mg|PF-06463922 was administered following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours) as 4 * 25 milligram (mg) tablets on Day 1 of Period 1.
11092373|NCT01539512|EG000|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280246|NCT02804399|OG001|Outcome|Rifampin 600 mg + PF-06463922 100 mg|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal from Day 1 to Day 9 of Period 2, except for rifampin dose on Day 8 of Period 2, which was administered simultaneously with PF-06463922. PF-06463922 100 mg (4 * 25 mg table) and rifampin were administered (rifampin followed by PF-06463922) following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours).
11280247|NCT02804399|OG001|Outcome|Rifampin 600 mg QD|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal for 9 days, except for rifampin dose on Day 8, which was administered simultaneously with PF-06463922.
11280248|NCT02804399|OG002|Outcome|Rifampin 600 mg + PF-06463922 100 mg|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal from Day 1 to Day 9 of Period 2, except for rifampin dose on Day 8 of Period 2, which was administered simultaneously with PF-06463922. PF-06463922 100 mg (4 * 25 mg table) and rifampin were administered (rifampin followed by PF-06463922) following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours).
11280249|NCT02804399|EG000|Reported Event|PF-06463922 100 mg|PF-06463922 was administered following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours) as 4 * 25 milligram (mg) tablets on Day 1 of Period 1.
11280250|NCT02804399|EG001|Reported Event|Rifampin 600 mg QD|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal for 9 days, except for rifampin dose on Day 8, which was administered simultaneously with PF-06463922.
11280251|NCT02804399|EG002|Reported Event|Rifampin 600 mg + PF-06463922 100 mg|Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal from Day 1 to Day 9 of Period 2, except for rifampin dose on Day 8 of Period 2, which was administered simultaneously with PF-06463922. PF-06463922 100 mg (4 * 25 mg table) and rifampin were administered (rifampin followed by PF-06463922) following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours).
11280252|NCT02804594|BG000|Baseline|N-acetyl Cysteine|"1250 mg of N-acetyl cysteine three times daily~N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily"
11280253|NCT02804594|BG001|Baseline|Placebo|"placebo three times daily~Placebo: placebo taken three times daily"
11280254|NCT02804594|BG002|Baseline|Total|Total of all reporting groups
11280255|NCT02804594|FG000|Participant Flow|N-acetyl Cysteine|"1250 mg of N-acetyl cysteine three times daily~N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily"
11092374|NCT01539512|EG001|Reported Event|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
11280256|NCT02804594|FG001|Participant Flow|Placebo|"placebo three times daily~Placebo: placebo taken three times daily"
11280257|NCT02804594|OG000|Outcome|N-acetyl Cysteine|"1250 mg of N-acetyl cysteine three times daily~N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily"
11280258|NCT02804594|OG001|Outcome|Placebo|"placebo three times daily~Placebo: placebo taken three times daily"
11280259|NCT02804594|EG000|Reported Event|N-acetyl Cysteine|"1250 mg of N-acetyl cysteine three times daily~N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily"
11280260|NCT02804594|EG001|Reported Event|Placebo|"placebo three times daily~Placebo: placebo taken three times daily"
11280261|NCT02804750|BG000|Baseline|Group 1: Low-dose Group|100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
11280262|NCT02804750|BG001|Baseline|Group 2: High-dose Group|250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
11280263|NCT02804750|BG002|Baseline|Total|Total of all reporting groups
11280264|NCT02804750|FG000|Participant Flow|Group 1: Low-dose Group|100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
11280265|NCT02804750|FG001|Participant Flow|Group 2: High-dose Group|250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
11280266|NCT02804750|OG000|Outcome|Group 1: Low-dose Group|100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
11280267|NCT02804750|OG001|Outcome|Group 2: High-dose Group|250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
11280268|NCT02804750|OG000|Outcome|Group 1: Low-dose Group|100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
11280269|NCT02804750|OG001|Outcome|Group 2: High-dose Group|250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
11280270|NCT02804750|EG000|Reported Event|Group 1: Low-dose Group|100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
11280271|NCT02804750|EG001|Reported Event|Group 2: High-dose Group|250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.
11280272|NCT02804763|BG000|Baseline|SOC + Placebo iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280273|NCT02804763|BG001|Baseline|SOC + DZP 6mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280274|NCT02804763|BG002|Baseline|SOC + DZP 24mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280275|NCT02804763|BG003|Baseline|SOC + DZP 45mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280276|NCT02804763|BG004|Baseline|Total Title|
11280277|NCT02804763|FG000|Participant Flow|SOC + Placebo iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280278|NCT02804763|FG001|Participant Flow|SOC + DZP 6mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280279|NCT02804763|FG002|Participant Flow|SOC + DZP 24mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280280|NCT02804763|FG003|Participant Flow|SOC + DZP 45mg/kg iv Q4W|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
11280281|NCT02804763|OG000|Outcome|SOC + Placebo iv Q4W (FAS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
11280282|NCT02804763|OG001|Outcome|SOC + DZP 6mg/kg iv Q4W (FAS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
11280283|NCT02804763|OG002|Outcome|SOC + DZP 24mg/kg iv Q4W (FAS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
11280284|NCT02804763|OG003|Outcome|SOC + DZP 45mg/kg iv Q4W (FAS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
11280285|NCT02804763|OG000|Outcome|SOC + Placebo iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).
11280286|NCT02804763|OG001|Outcome|SOC + DZP 6mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280287|NCT02804763|OG002|Outcome|SOC + DZP 24mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280288|NCT02804763|OG003|Outcome|SOC + DZP 45mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280289|NCT02804763|EG000|Reported Event|SOC + Placebo iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).
11280290|NCT02804763|EG001|Reported Event|SOC + DZP 6mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280291|NCT02804763|EG002|Reported Event|SOC + DZP 24mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280292|NCT02804763|EG003|Reported Event|SOC + DZP 45mg/kg iv Q4W (SS)|This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
11280293|NCT02805179|BG000|Baseline|High Dose Chemoradiation|Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
11280294|NCT02805179|FG000|Participant Flow|All Participants|Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
11280295|NCT02805179|OG000|Outcome|High Dose Chemoradiation|Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
11280296|NCT02805179|EG000|Reported Event|All Enrolled Patients|Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
11280297|NCT02805309|BG000|Baseline|Exercise & Cognitive Behavioral Int.|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.~Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins."
11280298|NCT02805309|BG001|Baseline|Exercise Alone|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins."
11280299|NCT02805309|BG002|Baseline|Attention Control Education Program|"Participants will receive telephone-based education sessions from a study health professional.~Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes."
11280300|NCT02805309|BG003|Baseline|Total|Total of all reporting groups
11280301|NCT02805309|FG000|Participant Flow|Exercise & Cognitive Behavioral Int.|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.~Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins."
11280302|NCT02805309|FG001|Participant Flow|Exercise Alone|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins."
11280303|NCT02805309|FG002|Participant Flow|Attention Control Education Program|"Participants will receive telephone-based education sessions from a study health professional.~Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes."
11280304|NCT02805309|OG000|Outcome|Exercise & Cognitive Behavioral Int.|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.~Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins."
11280305|NCT02805309|OG001|Outcome|Exercise Alone|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins."
11280306|NCT02805309|OG002|Outcome|Attention Control Education Program|"Participants will receive telephone-based education sessions from a study health professional.~Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes."
11280307|NCT02805309|EG000|Reported Event|Exercise & Cognitive Behavioral Int.|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.~Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins."
11280308|NCT02805309|EG001|Reported Event|Exercise Alone|"A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.~Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins."
11280309|NCT02805309|EG002|Reported Event|Attention Control Education Program|"Participants will receive telephone-based education sessions from a study health professional.~Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes."
11280310|NCT02805647|BG000|Baseline|Fracture/Study Group|The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
11280311|NCT02805647|BG001|Baseline|Control Group|The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
11280312|NCT02805647|BG002|Baseline|Total|Total of all reporting groups
11280313|NCT02805647|FG000|Participant Flow|Fracture/Study Group|The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
11280314|NCT02805647|FG001|Participant Flow|Control Group|The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
11280315|NCT02805647|OG000|Outcome|Fracture/Study Group|The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
11092375|NCT01539525|BG000|Baseline|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11280316|NCT02805647|OG001|Outcome|Control Group|The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
11280317|NCT02805647|EG000|Reported Event|Fracture/Study Group|The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
11280318|NCT02805647|EG001|Reported Event|Control Group|The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
11280319|NCT02805660|BG000|Baseline|Phase 1: Dose Escalation - 50 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280320|NCT02805660|BG001|Baseline|Phase 1: Dose Escalation - 70 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280321|NCT02805660|BG002|Baseline|Phase 1: Dose Escalation - 90 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280322|NCT02805660|BG003|Baseline|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280323|NCT02805660|BG004|Baseline|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280324|NCT02805660|BG005|Baseline|Phase 2: Combination Regimen - Cohort 3|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280325|NCT02805660|BG006|Baseline|Phase 2: Combination Regimen - Cohort 4|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280326|NCT02805660|BG007|Baseline|Total|Total of all reporting groups
11280327|NCT02805660|FG000|Participant Flow|Phase 1: Dose Escalation - 50 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280328|NCT02805660|FG001|Participant Flow|Phase 1: Dose Escalation - 70 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280329|NCT02805660|FG002|Participant Flow|Phase 1: Dose Escalation - 90 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280330|NCT02805660|FG003|Participant Flow|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70mg)."
11280331|NCT02805660|FG004|Participant Flow|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11337683|NCT03591146|BG001|Baseline|TLC590 380mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11092376|NCT01539525|BG001|Baseline|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11280332|NCT02805660|FG005|Participant Flow|Phase 2: Combination Regimen - Cohort 3|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280333|NCT02805660|FG006|Participant Flow|Phase 2: Combination Regimen - Cohort 4|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280334|NCT02805660|OG000|Outcome|Phase 1: Dose Escalation - 50 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280335|NCT02805660|OG001|Outcome|Phase 1: Dose Escalation - 70 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280336|NCT02805660|OG002|Outcome|Phase 1: Dose Escalation - 90 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280337|NCT02805660|OG003|Outcome|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280338|NCT02805660|OG004|Outcome|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280339|NCT02805660|OG005|Outcome|Phase 2: Combination Regimen - Cohort 3|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280340|NCT02805660|OG006|Outcome|Phase 2: Combination Regimen - Cohort 4|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280341|NCT02805660|OG000|Outcome|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280342|NCT02805660|OG001|Outcome|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280343|NCT02805660|OG002|Outcome|Phase 2: Combination Regimen - Cohort 3|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280344|NCT02805660|OG003|Outcome|Phase 2: Combination Regimen - Cohort 4|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11092377|NCT01539525|BG002|Baseline|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
11280345|NCT02805660|OG004|Outcome|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280346|NCT02805660|OG000|Outcome|Phase 1: Mocetinostat 50 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280347|NCT02805660|OG001|Outcome|Phase 1: Mocetinostat 70 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280348|NCT02805660|OG002|Outcome|Phase 1: Mocetinostat 90 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.~Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280349|NCT02805660|OG003|Outcome|Phase 1: Mocetinostat 40 mg|One participant in Phase 1 was de-escalated to 40 mg of mocetinostat.
11280350|NCT02805660|OG004|Outcome|Phase 2: Mocetinostat 70 mg|Participants in Phase 2 who received the recommended Phase 2 dose of 70 mg of mocetinostat.
11280351|NCT02805660|OG005|Outcome|Phase 2: Mocetinostat 50 mg|Six participants in Phase 2 were de-escalated to 50 mg of mocetinostat.
11280352|NCT02805660|OG000|Outcome|Durvalumab|Participants who received durvalumab during the study.
11280353|NCT02805660|OG003|Outcome|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280354|NCT02805660|EG000|Reported Event|Phase 1: Dose Escalation - 50 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.~Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280355|NCT02805660|EG001|Reported Event|Phase 1: Dose Escalation - 70 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.~Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280356|NCT02805660|EG002|Reported Event|Phase 1: Dose Escalation - 90 mg|"The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.~Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks."
11280357|NCT02805660|EG003|Reported Event|Phase 2: Combination Regimen - Cohort 1|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280358|NCT02805660|EG004|Reported Event|Phase 2: Combination Regimen - Cohort 2|"Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280359|NCT02805660|EG005|Reported Event|Phase 2: Combination Regimen - Cohort 3|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280360|NCT02805660|EG006|Reported Event|Phase 2: Combination Regimen - Cohort 4|"Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.~Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.~Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg)."
11280361|NCT02805790|BG000|Baseline|Elamipretide, Then Placebo|Participants first received 40 mg of elamipretide once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received placebo administered once daily subcutaneously for 4 weeks.
11280362|NCT02805790|BG001|Baseline|Placebo, Then Elamipretide|Participants first received placebo once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received 40 mg of elamipretide once daily subcutaneously for 4 weeks.
11280363|NCT02805790|BG002|Baseline|Total|Total of all reporting groups
11280364|NCT02805790|FG000|Participant Flow|Elamipretide, Then Placebo|"Participants first received 40 mg of elamipretide once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received placebo administered once daily subcutaneously for 4 weeks.~Elamipretide: 40 mg elamipretide administered once daily subcutaneously"
11280365|NCT02805790|FG001|Participant Flow|Placebo, Then Elamipretide|"Participants first received placebo once daily subcutaneously for 4 weeks. After a washout period of 4 weeks, they then received 40 mg of elamipretide once daily subcutaneously for 4 weeks.~Placebo: 4 weeks of treatment with placebo administered once daily subcutaneously"
11280366|NCT02805790|OG000|Outcome|Elamipretide|Participants who received 40mg Elamipretide administered once daily subcutaneously either the first or the last 4 weeks of the study.
11280367|NCT02805790|OG001|Outcome|Placebo|Participants who received Placebo administered once daily subcutaneously either the first or the last 4 weeks of the study.
11280368|NCT02805790|EG000|Reported Event|Elamipretide|Participants received 40 mg of elamipretide once daily subcutaneously for 4 weeks, either in the first 4 weeks of treatment, or in the last 4 weeks of treatment.
11280369|NCT02805790|EG001|Reported Event|Placebo|Participants received placebo once daily subcutaneously for 4 weeks, either in the first 4 weeks of treatment or the last 4 weeks of treatment.
11280370|NCT02805907|BG000|Baseline|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
11280371|NCT02805907|BG001|Baseline|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
11280372|NCT02805907|BG002|Baseline|Total|Total of all reporting groups
11280373|NCT02805907|FG000|Participant Flow|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
11280374|NCT02805907|FG001|Participant Flow|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
11280375|NCT02805907|OG000|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
11280376|NCT02805907|OG001|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
11280377|NCT02805907|EG000|Reported Event|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
11280378|NCT02805907|EG001|Reported Event|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
11280379|NCT02805972|BG000|Baseline|Naloxone, Then Placebo|At visit 1, participants were administered Naloxone, 4 mg/ 0.1 ml, intranasally, after eating. After the washout period between visits, at visit 2, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating.
11280380|NCT02805972|BG001|Baseline|Placebo, Then Naloxone|At visit 1, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. After the washout period between visits, at visit 2, participants were administered Naloxone, 4 mg/ 0.1 ml, intranasally, after eating.
11280381|NCT02805972|BG002|Baseline|Total|Total of all reporting groups
11280382|NCT02805972|FG000|Participant Flow|Experimental: Naloxone, Then Placebo|At the first intervention visit, participants were administered Naloxone, 4 mg / 0.1 ml, intranasally, after eating. After the washout period, at the second intervention visit, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating.
11280383|NCT02805972|FG001|Participant Flow|Experimental: Placebo, Then Naloxone|At the first intervention visit, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. After the washout period, at the second intervention visit, participants were administered Naloxone, 4 mg / 0.1 ml, intranasally, after eating.
11280384|NCT02805972|OG000|Outcome|Naloxone|"4 mg / 0.1 ml naloxone~Naloxone: 4 mg / 0.1 ml"
11280385|NCT02805972|OG001|Outcome|Placebo|"0.1 ml saline~Placebo: 0.1 ml"
11280386|NCT02805972|OG000|Outcome|Naloxone|Measurement of Cortisol here reported 25 min post Naloxone, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280387|NCT02805972|OG001|Outcome|Placebo|Measurement of Cortisol here reported 25 min post Placebo, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280388|NCT02805972|OG000|Outcome|Naloxone|Measurement of Cortisol here reported 55 min post Naloxone, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280389|NCT02805972|OG001|Outcome|Placebo|Measurement of Cortisol here reported 55 min post Placebo, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280390|NCT02805972|OG000|Outcome|Naloxone|Measurement of SOWS after Naloxone, among all participants who received Naloxone: 4 mg / 0.1 ml post eating at visit 1 and after a washout period, Placebo (saline): 0.1 ml post eating at visit 2, or were randomized to instead receive the same dosage of Placebo at visit 1 followed by a washout period and then Naloxone at visit 2.
11280391|NCT02805972|OG001|Outcome|Placebo|Measurement of SOWS after Placebo, among all participants who received Naloxone: 4 mg / 0.1 ml post eating at visit 1 and after a washout period, Placebo (saline): 0.1 ml post eating at visit 2, or were randomized to instead receive the same dosage of Placebo at visit 1 followed by a washout period and then Naloxone at visit 2.
11280392|NCT02805972|OG000|Outcome|Naloxone|Measurement of the abbreviated Subjective Opiate Withdrawal Scale here reported 30 min post Naloxone, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280393|NCT02805972|OG001|Outcome|Placebo|Measurement of the abbreviated Subjective Opiate Withdrawal Scale here reported 30 min post Placebo, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits.
11280394|NCT02805972|OG000|Outcome|Experimental: Naloxone, Then Placebo|Includes all participants randomized to receive Naloxone (4mg / 0.1 ml), then after a washout period, receive Placebo (saline, 0.1 ml), with reward-driven eating evaluated before the first study intervention.
11280395|NCT02805972|OG001|Outcome|Placebo, Then Naloxone|Includes all participants randomized to receive Placebo (saline, 0.1 ml), then after a washout period, receive Naloxone (4mg / 0.1 ml), with reward-driven eating evaluated before the first study intervention.
11280396|NCT02805972|EG000|Reported Event|Naloxone, Then Placebo|Visit 1 intervention condition: 4 mg / 0.1 ml Naloxone, followed by visit 2 condition: 0.1 ml Placebo (saline)
11280397|NCT02805972|EG001|Reported Event|Placebo, Then Naloxone|Visit 1 intervention condition: 0.1 ml Placebo (saline), followed by visit 2 condition: 4 mg / 0.1 ml Naloxone
11280398|NCT02806024|BG000|Baseline|Treatment Arm (Tranexamic Acid, or TXA)|"Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.~Tranexamic Acid"
11280399|NCT02806024|BG001|Baseline|Placebo Arm|"Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.~Placebo Drug: 50 cc Normal Saline IV"
11280400|NCT02806024|BG002|Baseline|Total|Total of all reporting groups
11280401|NCT02806024|FG000|Participant Flow|Treatment Arm (Tranexamic Acid, or TXA)|"Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.~Tranexamic Acid"
11280402|NCT02806024|FG001|Participant Flow|Placebo Arm|"Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.~Placebo Drug: 50 cc Normal Saline IV"
11280403|NCT02806024|OG000|Outcome|Treatment Arm (Tranexamic Acid, or TXA)|"Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.~Tranexamic Acid"
11280404|NCT02806024|OG001|Outcome|Placebo Arm|"Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.~Placebo Drug: 50 cc Normal Saline IV"
11280405|NCT02806024|EG000|Reported Event|Treatment Arm (Tranexamic Acid, or TXA)|"Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.~Tranexamic Acid"
11280406|NCT02806024|EG001|Reported Event|Placebo Arm|"Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.~Placebo Drug: 50 cc Normal Saline IV"
11280407|NCT02806232|BG000|Baseline|Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.
11280408|NCT02806232|BG001|Baseline|Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280409|NCT02806232|BG002|Baseline|Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg|Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280410|NCT02806232|BG003|Baseline|Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg|Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280411|NCT02806232|BG004|Baseline|Part 1, Cohort 5: Levo Praziquantel 30 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.
11280412|NCT02806232|BG005|Baseline|Part 1, Cohort 6: Levo Praziquantel 45 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.
11280413|NCT02806232|BG006|Baseline|Part 1, Cohort 7: Levo Praziquantel 60 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280414|NCT02806232|BG007|Baseline|Part 2, Cohort 8: Levo Praziquantel 50 mg/kg|Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280415|NCT02806232|BG008|Baseline|Part 2, Cohort 9: Levo Praziquantel 50 mg/kg|Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280416|NCT02806232|BG009|Baseline|Total|Total of all reporting groups
11280417|NCT02806232|FG000|Participant Flow|Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.
11280418|NCT02806232|FG001|Participant Flow|Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280419|NCT02806232|FG002|Participant Flow|Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg|Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280420|NCT02806232|FG003|Participant Flow|Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg|Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280421|NCT02806232|FG004|Participant Flow|Part 1, Cohort 5: Levo Praziquantel 30 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.
11280422|NCT02806232|FG005|Participant Flow|Part 1, Cohort 6: Levo Praziquantel 45 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.
11280423|NCT02806232|FG006|Participant Flow|Part 1, Cohort 7: Levo Praziquantel 60 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280424|NCT02806232|FG007|Participant Flow|Part 2, Cohort 8: Levo Praziquantel 50 mg/kg|Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280425|NCT02806232|FG008|Participant Flow|Part 2, Cohort 9: Levo Praziquantel 50 mg/kg|Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280426|NCT02806232|OG000|Outcome|Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.
11280427|NCT02806232|OG001|Outcome|Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280428|NCT02806232|OG002|Outcome|Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg|Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280429|NCT02806232|OG003|Outcome|Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg|Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280430|NCT02806232|OG004|Outcome|Part 1, Cohort 5: Levo Praziquantel 30 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.
11280431|NCT02806232|OG005|Outcome|Part 1, Cohort 6: Levo Praziquantel 45 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.
11280432|NCT02806232|OG006|Outcome|Part 1, Cohort 7: Levo Praziquantel 60 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280433|NCT02806232|OG007|Outcome|Part 2, Cohort 8: Levo Praziquantel 50 mg/kg|Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280434|NCT02806232|OG008|Outcome|Part 2, Cohort 9: Levo Praziquantel 50 mg/kg|Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280435|NCT02806232|EG000|Reported Event|Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.
11280436|NCT02806232|EG001|Reported Event|Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg|Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280437|NCT02806232|EG002|Reported Event|Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg|Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.
11280438|NCT02806232|EG003|Reported Event|Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg|Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280439|NCT02806232|EG004|Reported Event|Part 1, Cohort 5: Levo Praziquantel 30 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.
11280440|NCT02806232|EG005|Reported Event|Part 1, Cohort 6: Levo Praziquantel 45 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.
11280441|NCT02806232|EG006|Reported Event|Part 1, Cohort 7: Levo Praziquantel 60 mg/kg|Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.
11280442|NCT02806232|EG007|Reported Event|Part 2, Cohort 8: Levo Praziquantel 50 mg/kg|Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280443|NCT02806232|EG008|Reported Event|Part 2, Cohort 9: Levo Praziquantel 50 mg/kg|Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.
11280444|NCT02806414|BG000|Baseline|Ivermectin|"All subjects will be treated with topical ivermectin daily for up to 12 weeks.~Ivermectin"
11280445|NCT02806414|FG000|Participant Flow|Ivermectin|"All subjects will be treated with topical ivermectin daily for up to 12 weeks.~Ivermectin"
11280446|NCT02806414|OG000|Outcome|Ivermectin|"All subjects will be treated with topical ivermectin daily for up to 12 weeks.~Ivermectin"
11280447|NCT02806414|EG000|Reported Event|Ivermectin|"All subjects will be treated with topical ivermectin daily for up to 12 weeks.~Ivermectin"
11280448|NCT02806505|BG000|Baseline|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
11280449|NCT02806505|BG001|Baseline|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
11280450|NCT02806505|BG002|Baseline|Total|Total of all reporting groups
11280451|NCT02806505|FG000|Participant Flow|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
11280452|NCT02806505|FG001|Participant Flow|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
11280453|NCT02806505|OG000|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
11280454|NCT02806505|OG001|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
11280455|NCT02806505|EG000|Reported Event|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
11280456|NCT02806505|EG001|Reported Event|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
11280457|NCT02806544|BG000|Baseline|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
11280458|NCT02806544|FG000|Participant Flow|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
11280459|NCT02806544|OG000|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
11280460|NCT02806544|EG000|Reported Event|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
11280461|NCT02806713|BG000|Baseline|no Phenazopyridine|"Patients not receiving phenazopyridine (standard of care)~no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided"
11280462|NCT02806713|BG001|Baseline|Phenazopyridine|"Patients receiving phenazopyridine~Phenazopyridine"
11280463|NCT02806713|BG002|Baseline|Total|Total of all reporting groups
11280464|NCT02806713|FG000|Participant Flow|no Phenazopyridine|"Patients not receiving phenazopyridine (standard of care)~no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided"
11280465|NCT02806713|FG001|Participant Flow|Phenazopyridine|"Patients receiving phenazopyridine~Phenazopyridine"
11280466|NCT02806713|OG000|Outcome|no Phenazopyridine|"Patients not receiving phenazopyridine (standard of care)~no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided"
11280467|NCT02806713|OG001|Outcome|Phenazopyridine|"Patients receiving phenazopyridine~Phenazopyridine"
11280468|NCT02806713|EG000|Reported Event|no Phenazopyridine|"Patients not receiving phenazopyridine (standard of care)~no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided"
11280469|NCT02806713|EG001|Reported Event|Phenazopyridine|"Patients receiving phenazopyridine~Phenazopyridine"
11280470|NCT02806726|BG000|Baseline|All Study Participants|"Parts of a participant were allocated to different interventions:~Left side iDesign 1.3-PRESBY, Right side iDesign 1.3~Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY"
11280471|NCT02806726|FG000|Participant Flow|All Study Participants|"Parts of a participant were allocated to different interventions:~Left side iDesign 1.3-PRESBY, Right side iDesign 1.3~Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY"
11280472|NCT02806726|OG000|Outcome|iDesign 1.3-Presby Treatment (Experimental)|One of subject's eye (experimental) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign 1.3-PRESBY (presbyT-LASIK) treatments
11280473|NCT02806726|OG001|Outcome|iDesign CustomVue Treatments (Control)|One of subject's eye (control) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign CustomVue treatments
11280474|NCT02806726|EG000|Reported Event|All Study Participants|"Parts of a participant were allocated to different interventions:~Left side iDesign 1.3-PRESBY, Right side iDesign 1.3~Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY"
11280475|NCT02806869|BG000|Baseline|Arm #1 - Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280476|NCT02806869|BG001|Baseline|Arm #2 - Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280477|NCT02806869|BG002|Baseline|Total|Total of all reporting groups
11280478|NCT02806869|FG000|Participant Flow|Arm #1 - Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11092378|NCT01539525|BG003|Baseline|Total|Total of all reporting groups
11280479|NCT02806869|FG001|Participant Flow|Arm #2 - Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280480|NCT02806869|OG000|Outcome|Arm #1 - Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280481|NCT02806869|OG001|Outcome|Arm #2 - Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280482|NCT02806869|EG000|Reported Event|Arm #1 - Fasting State, 2 Study Visits|"Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280483|NCT02806869|EG001|Reported Event|Arm #2 - Fed State, 2 Study Visits|"Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red~Washout period of at least 7 days~Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red"
11280484|NCT02806895|BG000|Baseline|JZP-110/Placebo|JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280485|NCT02806895|BG001|Baseline|Placebo/JZP-110|Placebo for 7 days or JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280486|NCT02806895|BG002|Baseline|Total|Total of all reporting groups
11280487|NCT02806895|FG000|Participant Flow|(Treatment Period 1) JZP-110/Placebo|Subjects received JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in a counterbalanced order between Treatment Period 1 and Treatment Period 2.
11280488|NCT02806895|FG001|Participant Flow|(Treatment Period 2) Placebo/JZP-110|Subjects received Placebo for 7 days or JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) in a counterbalanced order between Treatment Period 1 and Treatment Period 2.
11280489|NCT02806895|OG000|Outcome|Placebo|Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280490|NCT02806895|OG001|Outcome|JZP-110|Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280491|NCT02806895|OG000|Outcome|Difference (JZP-110 -Placebo)|"JZP-110 - Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.~Placebo - Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order."
11280492|NCT02806895|EG000|Reported Event|Placebo|Subjects received a single oral daily dose of placebo for 7 days in treatment period 1 or treatment period 2 in a counterbalanced order.
11280493|NCT02806895|EG001|Reported Event|JZP-110|Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) in treatment period 1 or treatment period 2 in a counterbalanced order.
11280494|NCT02806908|BG000|Baseline|Placebo/JZP-110|Subjects received Placebo for 7 days or JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) in a counterbalanced order between Treatment Period 1 and Treatment Period 2.
11280495|NCT02806908|BG001|Baseline|JZP-110/Placebo|JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Treatment Period 1 or Treatment Period 2.
11280496|NCT02806908|BG002|Baseline|Total|Total of all reporting groups
11280497|NCT02806908|FG000|Participant Flow|Placebo/JZP-110|Subjects received Placebo for 7 days or JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) in a counterbalanced order between Treatment Period 1 and Treatment Period 2.
11280498|NCT02806908|FG001|Participant Flow|JZP-110/Placebo|Subjects received JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in a counterbalanced order between Treatment Period 1 and Treatment Period 2.
11280499|NCT02806908|OG000|Outcome|Placebo|Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280500|NCT02806908|OG001|Outcome|JZP-110|Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.
11280501|NCT02806908|OG000|Outcome|Difference (JZP-110 -Placebo)|"JZP-110 - Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) during Treatment Period 1 or Treatment Period 2 in a counterbalanced order.~Placebo - Subjects received a single oral daily dose of placebo for 7 days in Treatment Period 1 or Treatment Period 2 in a counterbalanced order."
11280502|NCT02806908|EG000|Reported Event|Placebo|Subjects received a single oral daily dose of placebo for 7 days.
11280503|NCT02806908|EG001|Reported Event|JZP-110|Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days)
11280504|NCT02806947|BG000|Baseline|Sirolimus|"Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization."
11280505|NCT02806947|BG001|Baseline|Prednisone|"Prednisone, standard of care therapy for GVHD, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Prednisone: Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment."
11280506|NCT02806947|BG002|Baseline|Total|Total of all reporting groups
11280507|NCT02806947|FG000|Participant Flow|Sirolimus|"Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization."
11280508|NCT02806947|FG001|Participant Flow|Prednisone|"Prednisone, standard of care therapy for GVHD, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Prednisone: Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment."
11280509|NCT02806947|OG000|Outcome|Sirolimus|"Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization."
11280510|NCT02806947|OG001|Outcome|Prednisone|"Prednisone, standard of care therapy for GVHD, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Prednisone: Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment."
11280511|NCT02806947|EG000|Reported Event|Sirolimus|"Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization."
11280512|NCT02806947|EG001|Reported Event|Prednisone|"Prednisone, standard of care therapy for GVHD, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Prednisone: Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment."
11280513|NCT02806973|BG000|Baseline|Nasal Glucagon|All enrolled participants.
11280514|NCT02806973|FG000|Participant Flow|Sequence 1 (T1/T2/T3/T4)|Treatment 1 (T1) = Single NG dose of 3 milligram (mg), T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
11280515|NCT02806973|FG001|Participant Flow|Sequence 2 (T2/T3/T4/T1)|T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later , T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg.
11280516|NCT02806973|FG002|Participant Flow|Sequence 3 (T3/T4/T1/T2)|T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
11280517|NCT02806973|FG003|Participant Flow|Sequence 4 (T4/T1/T2/T3)|T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
11280518|NCT02806973|OG000|Outcome|Nasal Glucagon Treatment 1|One dose of nasal glucagon.
11280519|NCT02806973|OG001|Outcome|Nasal Glucagon - Treatment 2|Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
11280520|NCT02806973|OG002|Outcome|Nasal Glucagon - Treatment 3|Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
11280521|NCT02806973|OG003|Outcome|Nasal Glucagon - Treatment 4|Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
11280522|NCT02806973|EG000|Reported Event|Nasal Glucagon Treatment 1|One dose of nasal glucagon.
11280523|NCT02806973|EG001|Reported Event|Nasal Glucagon - Treatment 2|Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
11280524|NCT02806973|EG002|Reported Event|Nasal Glucagon - Treatment 3|Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
11280525|NCT02806973|EG003|Reported Event|Nasal Glucagon - Treatment 4|Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
11280526|NCT02806986|BG000|Baseline|IGSC 20%|Following the previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and at the Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280527|NCT02806986|FG000|Participant Flow|IGSC 20%|Following the previous regimen phase (screening), participants were enrolled to receive 13 immune globulin subcutaneous (human), 20% caprylate/chromatography purified (IGSC 20%) infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 milligram per kilogram per week (mg/kg/week) if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and at the Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280528|NCT02806986|OG000|Outcome|IGSC 20% Treatment Stage 1|Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower). Dose adjustments were permitted in this phase per the study protocol and at the Investigator's discretion.
11280529|NCT02806986|OG001|Outcome|IGSC 20% Treatment Stage 2|Following treatment stage 1, participants received 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52. The IGSC 20% dose (mg/kg) remained constant with no dose adjustment permitted in this phase, unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280530|NCT02806986|OG002|Outcome|IGSC 20% Overall|Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280531|NCT02806986|OG000|Outcome|IGSC 20% Overall|Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280532|NCT02806986|OG001|Outcome|Previous Regimen|"Participants were required to attend the clinic for infusion with their previous ongoing (previous regimen) IVIG/SCIG regimen (pIV/pSC) to obtain 2 trough IgG levels (obtained prior to each pIV/pSC infusion) on each participant's previous regimen. Trough levels for total IgG determined during the Previous Regimen Phase were used to confirm final eligibility for participants entering the study to receive treatment with IGSC 20% (must be ≥500 milligrams per deciliter [mg/dL])."
11280533|NCT02806986|EG000|Reported Event|IGSC 20% Overall|Following previous regimen phase (screening), participants were enrolled to receive 13 IGSC 20% infusions at weekly intervals from baseline (Week 1) up to Week 13 in treatment stage 1. Participants were infused with IGSC 20% at a 1:1 dose-equivalent regimen from their previous regimen (or a minimum IGSC 20% dose of 100 mg/kg/week if the derived 1:1 dose from the previous regimen was lower) and followed by 39 IGSC 20% infusions at weekly intervals from Week 14 up to Week 52 in treatment stage 2. Dose adjustments were permitted per the study protocol and the at Investigator's discretion in the treatment stage 1. However, dose remained constant in treatment stage 2 unless it was absolutely medically necessary to change the dose, and such change required prior consultation with the Sponsor's Medical Monitor. A final follow-up visit occurred at Week 53.
11280534|NCT02807259|BG000|Baseline|Samvedana Plus Multi-level Intervention|Multi-level intervention working with sex workers, their intimate partners and communities to reduce intimate partner violence (IPV) and increase condom use
11280535|NCT02807259|BG001|Baseline|Wait-list Control|Wait list control.
11280536|NCT02807259|BG002|Baseline|Total|Total of all reporting groups
11280537|NCT02807259|FG000|Participant Flow|Samvedana Plus Multi-level Intervention|In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
11280538|NCT02807259|FG001|Participant Flow|Wait List Control|Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
11280539|NCT02807259|OG000|Outcome|Samvedana Plus Multi-level Intervention|In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
11280540|NCT02807259|OG001|Outcome|Wait List Control|Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
11287066|NCT02896907|BG000|Baseline|Treatment (FOLFIRINOX, Ascorbic Acid)|"Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: Given IV~Irinotecan Hydrochloride: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Ascorbic Acid: Given IV"
11280541|NCT02807259|OG000|Outcome|Multi-level Intervention|At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
11280542|NCT02807259|OG001|Outcome|Wait-list Control|Peer educators, HIV counselling, condom distribution. The intervention will rolled out to all participating villages after 24 months.
11280543|NCT02807259|EG000|Reported Event|Multi-level Intervention|At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
11280544|NCT02807259|EG001|Reported Event|Control|Peer educators, HIV counselling, condom distribution. The intervention will rolled out to all participating villages after 24 months.
11280545|NCT02807376|BG000|Baseline|Standard of Care|Facility's Current Instrumentation
11280546|NCT02807376|BG001|Baseline|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11280547|NCT02807376|BG002|Baseline|Total|Total of all reporting groups
11280548|NCT02807376|FG000|Participant Flow|Standard of Care|Facility's Current Instrumentation
11280549|NCT02807376|FG001|Participant Flow|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11280550|NCT02807376|OG000|Outcome|Standard of Care|Facility's Current Instrumentation
11280551|NCT02807376|OG001|Outcome|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11280552|NCT02807376|EG000|Reported Event|Standard of Care|Facility's Current Instrumentation
11280553|NCT02807376|EG001|Reported Event|Powered Vascular Stapler|Use of the ECHELON FLEX™ Powered Vascular Stapler
11280554|NCT02807402|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11280555|NCT02807402|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11280556|NCT02807402|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11280557|NCT02807402|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
11280558|NCT02807402|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.
11280559|NCT02807402|OG001|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11280560|NCT02807402|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir With RBV|Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
11280561|NCT02807402|OG001|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.
11280562|NCT02807402|OG002|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
11280563|NCT02807402|EG000|Reported Event|Paritaprevir/Ritonavir + Ombitasvir With RBV|Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
11280564|NCT02807402|EG001|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.
11280565|NCT02807402|EG002|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
10970525|NCT00910858|OG000|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970526|NCT00910858|OG001|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
10970527|NCT00910858|EG000|Reported Event|10 mg Lenalidomide|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11280566|NCT02807623|BG000|Baseline|Ibuprofen|"Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.~Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280567|NCT02807623|BG001|Baseline|Placebo|"Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.~oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280568|NCT02807623|BG002|Baseline|Compound Exercise of Push-ups|"Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.~Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt."
11280569|NCT02807623|BG003|Baseline|Total|Total of all reporting groups
11280570|NCT02807623|FG000|Participant Flow|Ibuprofen|"Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.~Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280571|NCT02807623|FG001|Participant Flow|Placebo|"Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.~oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280572|NCT02807623|FG002|Participant Flow|Compound Exercise of Push-ups|"Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.~Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt."
11280573|NCT02807623|OG000|Outcome|Ibuprofen|"Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.~Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280574|NCT02807623|OG001|Outcome|Placebo|"Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.~oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280575|NCT02807623|OG002|Outcome|Compound Exercise of Push-ups|"Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.~Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt."
11280576|NCT02807623|OG000|Outcome|Placebo|"Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.~oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280577|NCT02807623|OG001|Outcome|Ibuprofen|"Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.~Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280578|NCT02807623|OG000|Outcome|Baseline|Participants were evaluated for reddening of the skin at the vaccination site immediately after influenza vaccine receipt.
11280579|NCT02807623|OG001|Outcome|48-72 Hours After Vaccination|Participants were evaluated for reddening of the skin at the vaccination site 48-72 hours after influenza vaccine receipt.
11280580|NCT02807623|OG002|Outcome|21-28 Days After Vaccination|Participants were evaluated for reddening of the skin at the vaccination site 21-28 days after influenza vaccine receipt.
11280581|NCT02807623|OG000|Outcome|Baseline|Participants were evaluated for swelling at the vaccination site immediately after influenza vaccine receipt.
11280582|NCT02807623|OG001|Outcome|48-72 Hours After Vaccination|Participants were evaluated for swelling at the vaccination site 48-72 hours after influenza vaccine receipt.
11280583|NCT02807623|OG002|Outcome|21-28 Days After Vaccination|Participants were evaluated for swelling at the vaccination site 21-28 days after influenza vaccine receipt.
11280584|NCT02807623|OG000|Outcome|Compound Exercise of Push-ups|"Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.~Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt."
11280585|NCT02807623|EG000|Reported Event|Ibuprofen|"Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.~Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280586|NCT02807623|EG001|Reported Event|Placebo|"Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.~oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose."
11280587|NCT02807623|EG002|Reported Event|Compound Exercise of Push-ups|"Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.~Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt."
11280588|NCT02807844|BG000|Baseline|Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W
11280589|NCT02807844|BG001|Baseline|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W
11280590|NCT02807844|BG002|Baseline|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W
11280591|NCT02807844|BG003|Baseline|Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W
11280592|NCT02807844|BG004|Baseline|Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
11280593|NCT02807844|BG005|Baseline|Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W
11280594|NCT02807844|BG006|Baseline|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)
11280595|NCT02807844|BG007|Baseline|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)
11280596|NCT02807844|BG008|Baseline|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)
11280597|NCT02807844|BG009|Baseline|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
11280598|NCT02807844|BG010|Baseline|Total|Total of all reporting groups
11280599|NCT02807844|FG000|Participant Flow|Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W
11280600|NCT02807844|FG001|Participant Flow|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W
11280601|NCT02807844|FG002|Participant Flow|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W
11280602|NCT02807844|FG003|Participant Flow|Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W
11280603|NCT02807844|FG004|Participant Flow|Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
11280604|NCT02807844|FG005|Participant Flow|Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W
11280605|NCT02807844|FG006|Participant Flow|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)
11280606|NCT02807844|FG007|Participant Flow|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)
11280607|NCT02807844|FG008|Participant Flow|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)
11280608|NCT02807844|FG009|Participant Flow|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
11280609|NCT02807844|OG000|Outcome|Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W
11280610|NCT02807844|OG001|Outcome|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W
11280611|NCT02807844|OG002|Outcome|Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W
11280612|NCT02807844|OG003|Outcome|Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W
11280613|NCT02807844|OG004|Outcome|Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
11280614|NCT02807844|OG005|Outcome|Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W|Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W
11280615|NCT02807844|OG000|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)
11280616|NCT02807844|OG001|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)
11280617|NCT02807844|OG002|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)
11280618|NCT02807844|OG003|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
11280619|NCT02807844|OG006|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)
11280620|NCT02807844|OG007|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)
11280621|NCT02807844|OG008|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)
11280622|NCT02807844|OG009|Outcome|Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME|Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
11280623|NCT02807844|EG000|Reported Event|Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W|Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W
11280624|NCT02807844|EG001|Reported Event|Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W|Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W
11280625|NCT02807844|EG002|Reported Event|Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W|Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W
11280626|NCT02807844|EG003|Reported Event|Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W|Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W
11280627|NCT02807844|EG004|Reported Event|Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W|Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W
11280628|NCT02807844|EG005|Reported Event|Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W|Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W
11280629|NCT02807844|EG006|Reported Event|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC
11280630|NCT02807844|EG007|Reported Event|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC
11280631|NCT02807844|EG008|Reported Event|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC
11280632|NCT02807844|EG009|Reported Event|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME|Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME
11280633|NCT02807857|BG000|Baseline|Enrolled Patients|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels > 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set.
11280634|NCT02807857|FG000|Participant Flow|Enrolled Patients|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable with NT-proBNP levels > 600 pg/ml were described and analyzed in the Follow-Up set.
11280635|NCT02807857|OG000|Outcome|Enrolled Set|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.
11280636|NCT02807857|OG001|Outcome|Follow-Up Set|Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.
11280637|NCT02807857|OG000|Outcome|Follow-Up Set|Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.
11280638|NCT02807857|OG000|Outcome|Enrolled Patients|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels > 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set.
11280639|NCT02807857|OG000|Outcome|Follow-Up Set Visit 2 (6 Months)|Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml were referred to a cardiologist after 6 months (V2) for evaluation and were in the follow-up set
11280640|NCT02807857|OG000|Outcome|Enrolled Set|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe
11280641|NCT02807857|EG000|Reported Event|Enrolled Set|Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.
11280642|NCT02807857|EG001|Reported Event|Follow-Up Set|Patients who were considered clinically stable and with NT-proBNP levels > 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.
11280643|NCT02807948|BG000|Baseline|Pacemaker, ICD, or CRT Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280644|NCT02807948|FG000|Participant Flow|Pacemaker or CRT-P Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280645|NCT02807948|FG001|Participant Flow|ICD or CRT-D Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Implantable Cardioverter Defibrillatoror (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280646|NCT02807948|OG000|Outcome|Pacemaker or CRT-P Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280647|NCT02807948|OG000|Outcome|ICD or CRT-D Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Implantable Cardioverter Defibrillator or (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280648|NCT02807948|EG000|Reported Event|Pacemaker, ICD, or CRT Device Patients|"Subjects who need a non-thoracic clinically indicated scan~Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose"
11280649|NCT02808052|BG000|Baseline|Mild Renal Insufficiency|Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
11280650|NCT02808052|BG001|Baseline|Moderate Renal Insufficiency|Moderate renal insufficiency (eGFR 30 to < 60 mL/min/1.73m2)
11280651|NCT02808052|BG002|Baseline|Severe Renal Insufficiency|Severe renal insufficiency (eGFR < 30 mL/min/1.73m2), not receiving HD therapy
11280652|NCT02808052|BG003|Baseline|Total|Total of all reporting groups
11280653|NCT02808052|FG000|Participant Flow|Mild Renal Insufficiency|Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
11280654|NCT02808052|FG001|Participant Flow|Moderate Renal Insufficiency|Moderate renal insufficiency (eGFR 30 to < 60 mL/min/1.73m2)
11280655|NCT02808052|FG002|Participant Flow|Severe Renal Insufficiency|Severe renal insufficiency (eGFR < 30 mL/min/1.73m2), not receiving hemodialysis (HD) therapy
11280656|NCT02808052|OG000|Outcome|Mild Renal Insufficiency|Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
11280657|NCT02808052|OG001|Outcome|Moderate Renal Insufficiency|Moderate renal insufficiency (eGFR 30 to < 60 mL/min/1.73m2)
11280658|NCT02808052|OG002|Outcome|Severe Renal Insufficiency|Severe renal insufficiency (eGFR < 30 mL/min/1.73m2), not receiving HD therapy
11280659|NCT02808052|EG000|Reported Event|Mild Renal Insufficiency|Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
11280660|NCT02808052|EG001|Reported Event|Moderate Renal Insufficiency|Moderate renal insufficiency (eGFR 30 to < 60 mL/min/1.73m2)
11280661|NCT02808052|EG002|Reported Event|Severe Renal Insufficiency|Severe renal insufficiency (eGFR < 30 mL/min/1.73m2), not receiving HD therapy
11280662|NCT02808130|BG000|Baseline|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280663|NCT02808130|BG001|Baseline|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280664|NCT02808130|BG002|Baseline|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280665|NCT02808130|BG003|Baseline|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280666|NCT02808130|BG004|Baseline|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280667|NCT02808130|BG005|Baseline|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280668|NCT02808130|BG006|Baseline|Total|Total of all reporting groups
11280669|NCT02808130|FG000|Participant Flow|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280670|NCT02808130|FG001|Participant Flow|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280671|NCT02808130|FG002|Participant Flow|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280672|NCT02808130|FG003|Participant Flow|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11287067|NCT02896907|FG000|Participant Flow|Treatment (FOLFIRINOX, Ascorbic Acid)|"Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: Given IV~Irinotecan Hydrochloride: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Ascorbic Acid: Given IV"
11280673|NCT02808130|FG004|Participant Flow|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280674|NCT02808130|FG005|Participant Flow|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280675|NCT02808130|OG000|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280676|NCT02808130|OG001|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280677|NCT02808130|OG002|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280678|NCT02808130|OG003|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280679|NCT02808130|OG004|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280680|NCT02808130|OG005|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11337684|NCT03591146|BG002|Baseline|TLC590 570mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11280681|NCT02808130|OG003|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280682|NCT02808130|OG004|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280683|NCT02808130|OG005|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280684|NCT02808130|EG000|Reported Event|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280685|NCT02808130|EG001|Reported Event|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280686|NCT02808130|EG002|Reported Event|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280687|NCT02808130|EG003|Reported Event|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280688|NCT02808130|EG004|Reported Event|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11337685|NCT03591146|BG003|Baseline|TLC590 475mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11280689|NCT02808130|EG005|Reported Event|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
11280690|NCT02808312|BG000|Baseline|Cohort 1: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280691|NCT02808312|BG001|Baseline|Cohort 2: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280692|NCT02808312|BG002|Baseline|Cohort 1 & 2: Normal Hepatic Function|Matched normal hepatic function participants to mild or moderate hepatic impairment participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280693|NCT02808312|BG003|Baseline|Cohort 3: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280694|NCT02808312|BG004|Baseline|Cohort 3: Normal Hepatic Function|Matched normal hepatic function participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets ) or 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280695|NCT02808312|BG005|Baseline|Total|Total of all reporting groups
11280696|NCT02808312|FG000|Participant Flow|Cohort 1: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280697|NCT02808312|FG001|Participant Flow|Cohort 2: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280698|NCT02808312|FG002|Participant Flow|Cohort 1 & 2: Normal Hepatic Function|Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280699|NCT02808312|FG003|Participant Flow|Cohort 3: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280700|NCT02808312|FG004|Participant Flow|Cohort 3: Normal Hepatic Function|Matched normal hepatic function participants to severe hepatic impairment participants, received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280701|NCT02808312|OG000|Outcome|Cohort 1: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280702|NCT02808312|OG001|Outcome|Cohort 1: Normal Hepatic Function|Matched normal hepatic function participants to mild hepatic impairment participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280703|NCT02808312|OG002|Outcome|Cohort 2: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280704|NCT02808312|OG003|Outcome|Cohort 2: Normal Hepatic Function|Matched normal hepatic function participants to moderate hepatic impairment participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280705|NCT02808312|OG004|Outcome|Cohort 3: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280706|NCT02808312|OG005|Outcome|Cohort 3: Normal Hepatic Function|Matched normal hepatic function participants to severe hepatic impairment participants, received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280707|NCT02808312|OG001|Outcome|Cohort 2: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280708|NCT02808312|OG002|Outcome|Cohort 1 and 2: Normal Hepatic Function|Matched normal hepatic function participants to mild or moderate hepatic impairment participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280709|NCT02808312|OG003|Outcome|Cohort 3: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280710|NCT02808312|OG004|Outcome|Cohort 3: Normal Hepatic Function|Matched normal hepatic function participants to severe hepatic impairment participants, received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280711|NCT02808312|EG000|Reported Event|Cohort 1: Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280712|NCT02808312|EG001|Reported Event|Cohort 2: Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280713|NCT02808312|EG002|Reported Event|Cohort 1 and 2: Normal Hepatic Function|Matched normal hepatic function participants to mild or moderate hepatic impairment participants, received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
11280714|NCT02808312|EG003|Reported Event|Cohort 3: Severe Hepatic Impairment|Participants with severe hepatic impairment received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280715|NCT02808312|EG004|Reported Event|Cohort 3: Normal Hepatic Function|Matched normal hepatic function participants to severe hepatic impairment participants, received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
11280716|NCT02808338|BG000|Baseline|Screening|All participants that consented to the study.
11280717|NCT02808338|FG000|Participant Flow|Screening|All participants that consented to the study were considered for the participant flow. 15 participants were randomized to participate in the overnight in lab PSG's, these overnights were randomized to 1 of 4 interventions for each of the 4 overnights. This randomization scheme resulted in a large number of device sequences.
11280718|NCT02808338|OG000|Outcome|Philips BiPAP AutoSV Advanced System One|Philips Bilevel Postitive Airway Perssure (BiPAP) AutoSV Advanced System One: Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.
11280719|NCT02808338|OG001|Outcome|Modified Philips BiPAP ASV|Modified Philips BiPAP AutoServoventilation (ASV): This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.
11280720|NCT02808338|OG002|Outcome|ResMed S7 VPAP Adapt|ResMed S7 Variable Positive Airway Pressure (VPAP) Adapt: This device is FDA approved and will be set to predetermined setting.
11280721|NCT02808338|OG003|Outcome|ResMed S9 VPAP Adapt|ResMed S9 VPAP Adapt: This device is FDA approved and will be set to predetermined setting.
11280722|NCT02808338|EG000|Reported Event|Philips BiPAP AutoSV Advanced System One|"The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings.~P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto~Philips BiPAP AutoSV Advanced System One: Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting."
11280723|NCT02808338|EG001|Reported Event|Modified Philips BiPAP ASV|"The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto~Modified Philips BiPAP ASV: This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device."
11280724|NCT02808338|EG002|Reported Event|ResMed S7 VPAP Adapt|"This is an FDA approved device and the following settings will be administered:~EEP: 4 PSmin: 3 PSMax: 16~ResMed S7 VPAP Adapt: This device is FDA approved and will be set to predetermined setting."
11280725|NCT02808338|EG003|Reported Event|ResMed S9 VPAP Adapt|"This is an FDA approved device and the following settings will be administered:~EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off~ResMed S9 VPAP Adapt: This device is FDA approved and will be set to predetermined setting."
11280726|NCT02808338|EG004|Reported Event|Take Home - Modified Philips BiPAP ASV|After the overnight PSGs participants took home the Modified Philips BiPAP ASV for 30 days.
11280727|NCT02808429|BG000|Baseline|Placebo|Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
11280728|NCT02808429|BG001|Baseline|Atacicept 25 mg|Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
11280729|NCT02808429|BG002|Baseline|Atacicept 75 mg|Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
11280730|NCT02808429|BG003|Baseline|Total|Total of all reporting groups
11280731|NCT02808429|FG000|Participant Flow|Placebo|Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
11280732|NCT02808429|FG001|Participant Flow|Atacicept 25 mg|Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
11280733|NCT02808429|FG002|Participant Flow|Atacicept 75 mg|Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
11280734|NCT02808429|OG000|Outcome|Placebo|Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
11280735|NCT02808429|OG001|Outcome|Atacicept 25 mg|Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
11280736|NCT02808429|OG002|Outcome|Atacicept 75 mg|Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
11280737|NCT02808429|EG000|Reported Event|Placebo|Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
11280738|NCT02808429|EG001|Reported Event|Atacicept 25 mg|Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
11280739|NCT02808429|EG002|Reported Event|Atacicept 75 mg|Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
11280740|NCT02808819|BG000|Baseline|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11280741|NCT02808819|BG001|Baseline|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11280742|NCT02808819|BG002|Baseline|Total|Total of all reporting groups
11280743|NCT02808819|FG000|Participant Flow|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11280744|NCT02808819|FG001|Participant Flow|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11280745|NCT02808819|OG000|Outcome|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11280746|NCT02808819|OG001|Outcome|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11280747|NCT02808819|OG002|Outcome|Total|sum per row
11280748|NCT02808819|EG000|Reported Event|Benra 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
11280749|NCT02808819|EG001|Reported Event|Benra 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
11280750|NCT02808975|BG000|Baseline|Placebo|"Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week~Period B: Weeks 13-14- 1 SC injection each week~Period C: Weeks 15-23- 1 SC injection each week"
11280751|NCT02808975|BG001|Baseline|Adalimumab|"Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week~Period B: Weeks 13-14- 1 SC 40 mg injection each week~Period C: Weeks 15-23- 1 SC 40 mg injection each week"
11280752|NCT02808975|BG002|Baseline|Total|Total of all reporting groups
11280753|NCT02808975|FG000|Participant Flow|Placebo|"Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week~Period B: Weeks 13-14- 1 SC injection each week~Period C: Weeks 15-23- 1 SC injection each week"
11280754|NCT02808975|FG001|Participant Flow|Adalimumab|"Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week~Period B: Weeks 13-14- 1 SC 40 mg injection each week~Period C: Weeks 15-23- 1 SC 40 mg injection each week"
11280755|NCT02808975|OG000|Outcome|Placebo|"Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week~Period B: Weeks 13-14- 1 SC injection each week~Period C: Weeks 15-23- 1 SC injection each week"
11280756|NCT02808975|OG001|Outcome|Adalimumab|"Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week~Period B: Weeks 13-14- 1 SC 40 mg injection each week~Period C: Weeks 15-23- 1 SC 40 mg injection each week"
11280757|NCT02808975|EG000|Reported Event|Placebo|"Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week~Period B: Weeks 13-14- 1 SC injection each week~Period C: Weeks 15-23- 1 SC injection each week"
11280758|NCT02808975|EG001|Reported Event|Adalimumab|"Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week~Period B: Weeks 13-14- 1 SC 40 mg injection each week~Period C: Weeks 15-23- 1 SC 40 mg injection each week"
11280759|NCT02809053|BG000|Baseline|SAIT101|SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
11280760|NCT02809053|BG001|Baseline|MabThera|MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4.
11280761|NCT02809053|BG002|Baseline|Total|Total of all reporting groups
11280762|NCT02809053|FG000|Participant Flow|SAIT101|SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
11280763|NCT02809053|FG001|Participant Flow|MabThera|MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
11280764|NCT02809053|OG000|Outcome|SAIT101|SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4,
11280765|NCT02809053|OG001|Outcome|MabThera|MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
11280766|NCT02809053|EG000|Reported Event|SAIT101|SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
11280767|NCT02809053|EG001|Reported Event|MabThera|MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
11280768|NCT02809183|BG000|Baseline|Pooled Placebo|Pooled placebo treatment groups (Placebo administered twice daily [BID] for 14 days + Placebo administered once daily [QD] for 14 days)
11280769|NCT02809183|BG001|Baseline|1.5g TRC101 BID|1.5g TRC101 administered twice daily (BID) for 14 days
11280770|NCT02809183|BG002|Baseline|3g TRC101 BID|3g TRC101 administered twice daily (BID) for 14 days
11280771|NCT02809183|BG003|Baseline|4.5g TRC101 BID|4.5g TRC101 administered twice daily (BID) for 14 days
11280772|NCT02809183|BG004|Baseline|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11280773|NCT02809183|BG005|Baseline|Total|Total of all reporting groups
11280774|NCT02809183|FG000|Participant Flow|Placebo BID|Placebo administered twice daily (BID) for 14 days
11280775|NCT02809183|FG001|Participant Flow|1.5g TRC101 BID|1.5g TRC101 administered twice daily (BID) for 14 days
11280776|NCT02809183|FG002|Participant Flow|3g TRC101 BID|3g TRC101 administered twice daily (BID) for 14 days
11280777|NCT02809183|FG003|Participant Flow|4.5g TRC101 BID|4.5g TRC101 administered twice daily (BID) for 14 days
11280778|NCT02809183|FG004|Participant Flow|Placebo QD|Placebo administered once daily (QD) for 14 days
11280779|NCT02809183|FG005|Participant Flow|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11280780|NCT02809183|OG000|Outcome|Pooled Placebo|Pooled placebo treatment groups (Placebo administered twice daily [BID] for 14 days + Placebo administered once daily [QD] for 14 days)
11280781|NCT02809183|OG001|Outcome|1.5g TRC101 BID|1.5g TRC101 administered twice daily (BID) for 14 days
11280782|NCT02809183|OG002|Outcome|3g TRC101 BID|3g TRC101 administered twice daily (BID) for 14 days
11280783|NCT02809183|OG003|Outcome|4.5g TRC101 BID|4.5g TRC101 administered twice daily (BID) for 14 days
11280784|NCT02809183|OG004|Outcome|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11280785|NCT02809183|OG000|Outcome|Combined TRC101|Combined groups treated with TRC101 for 14 days (TRC101 BID: 1.5g, 3g and 4.5g; TRC101 QD: 6g)
11280786|NCT02809183|OG001|Outcome|Combined TRC101|Combined groups treated with TRC101 for 14 Days (TRC101 BID: 1.5g, 3g and 4.5g; TRC101 QD: 6g)
11280787|NCT02809183|OG000|Outcome|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11280788|NCT02809183|OG001|Outcome|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11280789|NCT02809183|OG000|Outcome|3g TRC101 BID|3g TRC101 administered twice daily (BID) for 14 days
11280790|NCT02809183|EG000|Reported Event|Pooled Placebo|Pooled Placebo treatment group (Placebo administered twice daily [BID] for 14 days + Placebo administered once daily [QD] for 14 days)
11280791|NCT02809183|EG001|Reported Event|1.5g TRC101 BID|1.5g TRC101 administered twice daily (BID) for 14 days
11280792|NCT02809183|EG002|Reported Event|3g TRC101 BID|3g TRC101 administered twice daily (BID) for 14 days
11280793|NCT02809183|EG003|Reported Event|4.5g TRC101 BID|4.5g TRC101 administered twice daily (BID) for 14 days
11280794|NCT02809183|EG004|Reported Event|6g TRC101 QD|6g TRC101 administered once daily (QD) for 14 days
11287068|NCT02896907|OG000|Outcome|Treatment (FOLFIRINOX, Ascorbic Acid)|"Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: Given IV~Irinotecan Hydrochloride: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Ascorbic Acid: Given IV"
11337686|NCT03591146|BG004|Baseline|Naropin 150mg|"Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial~Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL"
11280795|NCT02809430|BG000|Baseline|CPAP Intervention|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot problems with the device.
11280796|NCT02809430|FG000|Participant Flow|CPAP Intervention|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
11280797|NCT02809430|OG000|Outcome|CPAP Intervention|The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
11280798|NCT02809430|OG000|Outcome|CPAP Intervention|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
11280799|NCT02809430|OG000|Outcome|Adherent Participants|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
11280800|NCT02809430|OG001|Outcome|Non-adherent Participants|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
11280801|NCT02809430|EG000|Reported Event|CPAP Intervention|Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's CPAP to encourage adherence to treatment and troubleshoot any problems with the device.
11280802|NCT02809833|BG000|Baseline|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
11280803|NCT02809833|FG000|Participant Flow|Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
11280804|NCT02809833|OG000|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
11280805|NCT02809833|EG000|Reported Event|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
11280806|NCT02809846|BG000|Baseline|Quell Device|"Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.~For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz.~Quell"
11280807|NCT02809846|BG001|Baseline|Sham Quell Device|"Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz~Sham Quell"
11280808|NCT02809846|BG002|Baseline|Total|Total of all reporting groups
11280809|NCT02809846|FG000|Participant Flow|Quell Device|"Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.~For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz.~Quell"
11280810|NCT02809846|FG001|Participant Flow|Sham Quell Device|"Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz~Sham Quell"
11280811|NCT02809846|OG000|Outcome|Quell Device|"Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.~For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz.~Quell"
11280812|NCT02809846|OG001|Outcome|Sham Quell Device|"Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz~Sham Quell"
11280813|NCT02809846|EG000|Reported Event|Quell Device|"Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.~For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz.~Quell"
11280814|NCT02809846|EG001|Reported Event|Sham Quell Device|"Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz~Sham Quell"
11280815|NCT02809859|BG000|Baseline|Investigational CPAP Device|"Fisher & Paykel Healthcare CPAP Device~Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device"
11280816|NCT02809859|FG000|Participant Flow|Investigational CPAP Device|"Fisher & Paykel Healthcare CPAP Device~Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device"
11280817|NCT02809859|OG000|Outcome|Investigational CPAP Device|"Fisher & Paykel Healthcare CPAP Device~Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device"
11280818|NCT02809859|EG000|Reported Event|Investigational CPAP Device|"Fisher & Paykel Healthcare CPAP Device~Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device"
11280819|NCT02809911|BG000|Baseline|Sham of Provant|"Sham of Provant Therapy System~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
11280820|NCT02809911|BG001|Baseline|Active Provant|"Active Provant Treatment~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
11280821|NCT02809911|BG002|Baseline|Total|Total of all reporting groups
11280822|NCT02809911|FG000|Participant Flow|Sham of Provant|"Sham of Provant Therapy System~Provant"
11280823|NCT02809911|FG001|Participant Flow|Active Provant|"Active Provant Treatment~Provant"
11280824|NCT02809911|OG000|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
11280825|NCT02809911|OG001|Outcome|Active Provant|"Active Provant Treatment~Provant"
11280826|NCT02809911|EG000|Reported Event|Sham of Provant|"Sham of Provant Therapy System~Provant"
11280827|NCT02809911|EG001|Reported Event|Active Provant|"Active Provant Treatment~Provant"
11337687|NCT03591146|BG005|Baseline|Total|Total of all reporting groups
11280828|NCT02809976|BG000|Baseline|Ruxolitinib 1.5% Phosphate Cream|"Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.~Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20"
11280829|NCT02809976|FG000|Participant Flow|Ruxolitinib 1.5% Phosphate Cream|"Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.~Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20"
11280830|NCT02809976|OG000|Outcome|Ruxolitinib 1.5% Phosphate Cream|"Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.~Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20"
11280831|NCT02809976|EG000|Reported Event|Ruxolitinib 1.5% Phosphate Cream|"Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.~Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20"
11280832|NCT02810327|BG000|Baseline|MZ Heterozygote With Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280833|NCT02810327|BG001|Baseline|MZ Heterozygote Without Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort do not have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280834|NCT02810327|BG002|Baseline|Total|Total of all reporting groups
11280835|NCT02810327|FG000|Participant Flow|MZ Heterozygote With Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280836|NCT02810327|FG001|Participant Flow|MZ Heterozygote Without Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort do not have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280837|NCT02810327|OG000|Outcome|MZ Heterozygote With Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280838|NCT02810327|OG001|Outcome|MZ Heterozygote Without Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort do not have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280839|NCT02810327|EG000|Reported Event|MZ Heterozygote With Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280840|NCT02810327|EG001|Reported Event|MZ Heterozygote Without Symptoms of COPD|"Individuals who have previously had testing for Alpha-1 antitrypsin deficiency with genotype MZ (PiMZ) results. Individuals in this cohort do not have symptoms or clinical diagnosis of COPD.~Genetic Sequencing: Sequencing of the SERPINA1 gene"
11280841|NCT02810340|BG000|Baseline|MCV-5 With Adjuvant|"Received a single intramuscular injection of Adjuvanted MCV-5.~Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant."
11280842|NCT02810340|BG001|Baseline|MCV-5 Without Adjuvant|"Received a single intramuscular injection of Non-Adjuvanted MCV-5.~Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM)."
11280843|NCT02810340|BG002|Baseline|Menactra®|"Received a single intramuscular injection of Menactra.~Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation."
11280844|NCT02810340|BG003|Baseline|Total|Total of all reporting groups
11280845|NCT02810340|FG000|Participant Flow|MCV-5 With Adjuvant|"Received a single intramuscular injection of Adjuvanted MCV-5.~Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant."
11280846|NCT02810340|FG001|Participant Flow|MCV-5 Without Adjuvant|"Received a single intramuscular injection of Non-Adjuvanted MCV-5.~Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM)."
11280847|NCT02810340|FG002|Participant Flow|Menactra®|"Received a single intramuscular injection of Menactra.~Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation."
11280848|NCT02810340|OG000|Outcome|MCV-5 With Adjuvant|"Received a single intramuscular injection of Adjuvanted MCV-5.~Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant."
11280849|NCT02810340|OG001|Outcome|MCV-5 Without Adjuvant|"Received a single intramuscular injection of Non-Adjuvanted MCV-5.~Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM)."
11280850|NCT02810340|OG002|Outcome|Menactra®|"Received a single intramuscular injection of Menactra.~Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation."
11280851|NCT02810340|EG000|Reported Event|MCV-5 With Adjuvant|"Received a single intramuscular injection of Adjuvanted MCV-5.~Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant."
11280852|NCT02810340|EG001|Reported Event|MCV-5 Without Adjuvant|"Received a single intramuscular injection of Non-Adjuvanted MCV-5.~Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM)."
11280853|NCT02810340|EG002|Reported Event|Menactra®|"Received a single intramuscular injection of Menactra.~Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation."
11280854|NCT02810392|BG000|Baseline|Intranasal Insulin|"Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks."
11280855|NCT02810392|BG001|Baseline|Intranasal Saline|"Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline"
11280856|NCT02810392|BG002|Baseline|Total|Total of all reporting groups
11280857|NCT02810392|FG000|Participant Flow|Intranasal Insulin|"Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks."
11280858|NCT02810392|FG001|Participant Flow|Intranasal Saline|"Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline"
11280859|NCT02810392|OG000|Outcome|Intranasal Insulin|"Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks."
11280860|NCT02810392|OG001|Outcome|Intranasal Saline|"Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline"
11280861|NCT02810392|EG000|Reported Event|Intranasal Insulin|"Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks."
11287069|NCT02896907|EG000|Reported Event|Treatment (FOLFIRINOX, Ascorbic Acid)|"Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~Oxaliplatin: Given IV~Irinotecan Hydrochloride: Given IV~Leucovorin Calcium: Given IV~Fluorouracil: Given IV~Ascorbic Acid: Given IV"
11280862|NCT02810392|EG001|Reported Event|Intranasal Saline|"Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.~Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline"
11280863|NCT02810509|BG000|Baseline|Short Term Wafarin-treated Cohort|"Admission due to AF-related ischemic stroke (known AF or newly detected AF)~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days < 90 days"
11280864|NCT02810509|BG001|Baseline|Long Term Warfarin-treated Cohort|"Admission due to AF-related ischemic stroke~Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period~For Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment~TTR evaluable days ≥ 90 days"
11280865|NCT02810509|BG002|Baseline|Total|Total of all reporting groups
11280866|NCT02810509|FG000|Participant Flow|Short Term Wafarin-treated Cohort|"admission due to AF-related ischemic stroke (known AF or newly detected AF)~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days < 90 days"
11280867|NCT02810509|FG001|Participant Flow|Long Term Warfarin-treated Cohort|"admission due to AF-related ischemic stroke (known AF or newly detected AF)~long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days ≥ 90 days"
11280868|NCT02810509|OG000|Outcome|Short-term Cohort|"admission due to AF-related ischemic stroke (known AF or newly detected AF)~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days < 90 days"
11280869|NCT02810509|OG001|Outcome|Long-term Cohort|"admission due to AF-related ischemic stroke (known AF or newly detected AF)~long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days ≥ 90 days"
11280870|NCT02810509|OG000|Outcome|Short-term Cohort|"Admission due to AF-related ischemic stroke (known AF or newly detected AF)~for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment~TTR evaluable days < 90 days"
11280871|NCT02810509|OG001|Outcome|Long-term Cohort|"Admission due to AF-related ischemic stroke~Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period~For Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment~TTR evaluable days ≥ 90 days"
11280872|NCT02810509|EG000|Reported Event|Warfarin-initiated Cohort|"Admission due to AF-related ischemic stroke~Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period~For Time in therapeutic range (TTR) calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment"
11280873|NCT02810509|EG001|Reported Event|Long Term Warfarin-treated Cohort|"Admission due to AF-related ischemic stroke~Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period~For Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment~TTR evaluable days ≥ 90 days"
11280874|NCT02810873|BG000|Baseline|F-18-FDG Whole-body Scan|"STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280875|NCT02810873|BG001|Baseline|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280876|NCT02810873|BG002|Baseline|Total|Total of all reporting groups
11280877|NCT02810873|FG000|Participant Flow|F-18-FDG Whole-body Scan|STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
11280878|NCT02810873|FG001|Participant Flow|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280879|NCT02810873|OG000|Outcome|F-18-FDG Whole-body Scan|STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
11280880|NCT02810873|OG001|Outcome|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280881|NCT02810873|OG001|Outcome|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280882|NCT02810873|EG000|Reported Event|F-18-FDG Whole-body Scan|"STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280883|NCT02810873|EG001|Reported Event|No F-18-FDG Scan|"STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.~Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan~Positron Emission Tomography: Undergo PET Positron Emission Tomography scan~Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan~Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan"
11280884|NCT02810951|BG000|Baseline|FCX-007|"In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B.~In Phase II the study will target enrolling subjects (aged seven (7) or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects.~All subjects will receive FCX-007 into intact skin as well as to one or more paired target wounds at least one time during the study with a possible second administration pending laboratory results.~One wound in each target wound pair will be used as control for efficacy and safety evaluations. FCX-007 administered wounds will be compared within paired target wounds to untreated wounds.~FCX-007: FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional collagen VII. FCX-007 cell suspension is injected intradermally."
11280885|NCT02810951|FG000|Participant Flow|All Study Participants|All subjects will receive FCX-007 intradermal injections into a treated wound in a target pair and will have no FCX-007 injections into the other control wound in the target pair.
11280886|NCT02810951|OG000|Outcome|Subjects Who Received FCX-007 Injections|All subjects who received FCX-007 injections in at least one target wound.
11280887|NCT02810951|OG000|Outcome|Treated Wounds|FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional collagen 7 (COL7). FCX-007 cell suspension is injected intradermally.
11280888|NCT02810951|OG001|Outcome|Untreated Wounds|No FCX-007 injected
11280889|NCT02810951|EG000|Reported Event|FCX-007|"In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B.~In Phase II the study will target enrolling subjects (aged seven (7) or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects.~All subjects will receive FCX-007 into intact skin as well as to one or more paired target wounds at least one time during the study with a possible second administration pending laboratory results.~One wound in each target wound pair will be used as control for efficacy and safety evaluations. FCX-007 administered wounds will be compared within paired target wounds to untreated wounds.~FCX-007: FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional collagen VII. FCX-007 cell suspension is injected intradermally."
11280890|NCT02810964|BG000|Baseline|Sulforaphane Nutraceutical|Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
11280891|NCT02810964|BG001|Baseline|Identical-appearing Placebo|Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
11280892|NCT02810964|BG002|Baseline|Total|Total of all reporting groups
11280893|NCT02810964|FG000|Participant Flow|Sulforaphane Nutraceutical|Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
11280894|NCT02810964|FG001|Participant Flow|Identical-appearing Placebo|Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
11280895|NCT02810964|OG000|Outcome|Sulforaphane Nutraceutical|Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
11280896|NCT02810964|OG001|Outcome|Identical-appearing Placebo|Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
11280897|NCT02810964|EG000|Reported Event|Sulforaphane Nutraceutical|Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
11280898|NCT02810964|EG001|Reported Event|Identical-appearing Placebo|Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
11280899|NCT02811159|BG000|Baseline|Telapristone Acetate 12 mg|Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
11280900|NCT02811159|FG000|Participant Flow|Telapristone Acetate 12 mg|Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
11280901|NCT02811159|OG000|Outcome|Telapristone Acetate 12 mg|Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
11280902|NCT02811159|EG000|Reported Event|Telapristone Acetate 12 mg|Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
11280903|NCT02811302|BG000|Baseline|Single Cohort|Blinded capnography monitoring - all subjects enrolled
11280904|NCT02811302|FG000|Participant Flow|Full Analysis Set|Blinded capnography monitoring - all subjects enrolled
11280905|NCT02811302|OG000|Outcome|Full Analysis Set|Blinded Capnography Monitoring - All subjects enrolled
11280906|NCT02811302|OG000|Outcome|Full Analysis Dataset|All subjects enrolled
11280907|NCT02811302|EG000|Reported Event|Blinded Capnography Monitoring|"Subjects were clinically monitored through standard methods (standard clinical practice at the site), as well as with continuous data collection from the Capnostream monitor for a maximum of 48 hours. The monitoring period started for subjects once they arrived on the ward, for those subjects where opioid therapy was initiated prior to arrival on the hospital ward. Monitoring was permitted to be discontinued after a minimum of 4 hours from the last dose of opioid therapy received or if the subject was discharged from the hospital ward.~No treatments were administered for this study. This study was observational in nature for all subjects. The capnography monitor served primarily as a data collection method. The capnography monitor screen was blinded, and alarms silenced for all subjects."
11280908|NCT02811419|BG000|Baseline|I-scan|"Inspection with i-scan surface enhancement~i-scan: examination will be performed with i-scan digital enhancement"
11280909|NCT02811419|BG001|Baseline|Standard High-definition White Light|"Inspection with standard high-definition white light (usual care)~standard high-definition white light: examination will be performed with high-definition white light"
11280910|NCT02811419|BG002|Baseline|Total|Total of all reporting groups
11280911|NCT02811419|FG000|Participant Flow|Intervention (I-scan)|i-scan 1 (surface enhancement with contrast enhancement)
11280912|NCT02811419|FG001|Participant Flow|Control (HDWL)|HDWL (High definition white light)
11280913|NCT02811419|OG000|Outcome|Intervention (I-scan)|i-scan 1 (surface enhancement with contrast enhancement)
11280914|NCT02811419|OG001|Outcome|Control (HDWL)|HDWL (High definition white light)
11280915|NCT02811419|EG000|Reported Event|Intervention (I-scan)|i-scan 1 (surface enhancement with contrast enhancement)
11280916|NCT02811419|EG001|Reported Event|Control (HDWL)|HDWL (High definition white light)
11280917|NCT02811445|BG000|Baseline|High Functioning|Defined by a short physical performance battery score (SPPB) greater than or equal to 11.
11280918|NCT02811445|BG001|Baseline|Low Functioning|Defined by a short physical performance battery score (SPPB) less than or equal to 7.
11280919|NCT02811445|BG002|Baseline|Total|Total of all reporting groups
11280920|NCT02811445|FG000|Participant Flow|High Functioning|Defined by a short physical performance battery score (SPPB) greater than or equal to 11.
11280921|NCT02811445|FG001|Participant Flow|Low Functioning|Defined by a short physical performance battery score (SPPB) less than or equal to 7.
11280922|NCT02811445|OG000|Outcome|High Functioning|Defined by a short physical performance battery score (SPPB) greater than or equal to 11.
11280923|NCT02811445|OG001|Outcome|Low Functioning|Defined by a short physical performance battery score (SPPB) less than or equal to 7.
11280924|NCT02811445|EG000|Reported Event|High Functioning|Defined by a short physical performance battery score (SPPB) greater than or equal to 11.
11280925|NCT02811445|EG001|Reported Event|Low Functioning|Defined by a short physical performance battery score (SPPB) less than or equal to 7.
11280926|NCT02811640|BG000|Baseline|Study Participants|"Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital~Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion"
11280927|NCT02811640|FG000|Participant Flow|Study Participants|"Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital~Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion"
11280928|NCT02811640|OG000|Outcome|Study Participants|"Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital~Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion"
11280929|NCT02811640|EG000|Reported Event|Study Participants|"Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital~Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion"
11280930|NCT02811965|BG000|Baseline|Healthy Research Subjects|Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
11280931|NCT02811965|FG000|Participant Flow|Healthy Research Subjects|Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
11280932|NCT02811965|OG000|Outcome|Control|Pressure mapping is performed without a heel offloading intervention applied.
11280933|NCT02811965|OG001|Outcome|Pillow Condition 1|Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
11280934|NCT02811965|OG002|Outcome|Pillow Condition 2|Pressure mapping is performed with the Pillow condition 2 applied to the heel.
11280935|NCT02811965|OG003|Outcome|Heel Foam Pillow|Pressure mapping is performed with the heel foam pillow device applied to the heel.
11280936|NCT02811965|OG004|Outcome|Offloading Device A|Pressure mapping is performed with Offloading Device A applied to the heel.
11280937|NCT02811965|OG005|Outcome|Offloading Device B|Pressure mapping is performed with Offloading Device B applied to the heel.
11280938|NCT02811965|OG006|Outcome|Offloading Device C|Pressure mapping is performed with Offloading Device C applied to the heel.
11280939|NCT02811965|EG000|Reported Event|Control|Pressure mapping is performed without a heel offloading intervention applied.
11280940|NCT02811965|EG001|Reported Event|Pillow Condition 1|Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
11280941|NCT02811965|EG002|Reported Event|Pillow Condition 2|Pressure mapping is performed with the Pillow condition 2 applied to the heel.
11280942|NCT02811965|EG003|Reported Event|Heel Foam Pillow|Pressure mapping is performed with the heel foam pillow device applied to the heel.
11280943|NCT02811965|EG004|Reported Event|Offloading Device A|Pressure mapping is performed with Offloading Device A applied to the heel.
11280944|NCT02811965|EG005|Reported Event|Offloading Device B|Pressure mapping is performed with Offloading Device B applied to the heel.
11280945|NCT02811965|EG006|Reported Event|Offloading Device C|Pressure mapping is performed with Offloading Device C applied to the heel.
11280946|NCT02812160|BG000|Baseline|Spatz3 Adjustable Balloon|"Spatz3 Adjustable Balloon with Dietary and exercise counselling~Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed"
11280947|NCT02812160|BG001|Baseline|Control|Dietary and Exercise counselling
11280948|NCT02812160|BG002|Baseline|Total|Total of all reporting groups
11280949|NCT02812160|FG000|Participant Flow|Spatz3 Adjustable Balloon|"Spatz3 Adjustable Balloon with Dietary and exercise counselling~Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed"
11280950|NCT02812160|FG001|Participant Flow|Control|Dietary and Exercise counselling
11280951|NCT02812160|OG000|Outcome|Spatz3 Adjustable Balloon|"Spatz3 Adjustable Balloon with Dietary and exercise counselling~Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed"
11280952|NCT02812160|OG001|Outcome|Control|Dietary and Exercise counselling
11280953|NCT02812160|EG000|Reported Event|Spatz3 Adjustable Balloon|"Spatz3 Adjustable Balloon with Dietary and exercise counselling~Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed"
11280954|NCT02812160|EG001|Reported Event|Control|Dietary and Exercise counselling
11280955|NCT02812186|BG000|Baseline|Deep to Moderate NMB|This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
11280956|NCT02812186|BG001|Baseline|Moderate to Deep NMB|This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
11280957|NCT02812186|BG002|Baseline|Total|Total of all reporting groups
11280958|NCT02812186|FG000|Participant Flow|Deep to Moderate Neuromuscular Block (NMB)|"This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.~Rocuronium"
11280959|NCT02812186|FG001|Participant Flow|Moderate to Deep NMB|"This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.~Rocuronium"
11280960|NCT02812186|OG000|Outcome|Deep NMB|This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery
11280961|NCT02812186|OG001|Outcome|Moderate NMB|This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery
11280962|NCT02812186|OG000|Outcome|Deep NMB|This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery
11280963|NCT02812186|OG001|Outcome|Moderate NMB|This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery
11280964|NCT02812186|OG001|Outcome|ModerateNMB|This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery
11280965|NCT02812186|EG000|Reported Event|Deep NMB|This group will underwent neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery
11280966|NCT02812186|EG001|Reported Event|Moderate NMB|This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery
11280967|NCT02812238|BG000|Baseline|All Subjects|Baseline data for all subjects on the study.
11280968|NCT02812238|FG000|Participant Flow|Nicotinamide Riboside, Then Placebo|These subjects were first administered Nicotinamide riboside at 1000mg/day or placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to placebo for one additional week.
11280969|NCT02812238|FG001|Participant Flow|Placebo, Then Nicotinamide Riboside|These subjects were first administered Placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to Nicotinamide riboside at 1000mg/day for one week.
11280970|NCT02812238|OG000|Outcome|Nicotinamide Riboside|In this crossover design the study subjects from both arms that had received NR at 1000mg/days/7days, were combined to analyze the effect of NR on IL-1beta secretion in response to refeeding.
11280971|NCT02812238|OG001|Outcome|Placebo|In this crossover design the study subjects from both arms that had received placebo for days, were combined to analyze the effect of NR on IL-1beta secretion in response to refeeding.
11280972|NCT02812238|EG000|Reported Event|Nicotinamide Riboside|These subjects were administered Nicotinamide riboside
11280973|NCT02812238|EG001|Reported Event|Placebo|These subjects were administered Placebo
11280974|NCT02812342|BG000|Baseline|Tofacitinib Ointment|"Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.~Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth."
11287070|NCT02897115|BG000|Baseline|Treat-to-Target (T2T)|Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
11280975|NCT02812342|FG000|Participant Flow|Tofacitinib Ointment|"Patients with alopecia areata (AA) (with at least 2 patches of alopecia involving the scalp), alopecia totalis (AT) or alopecia universalis (AU) will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and the end of study.~Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and end of study."
11280976|NCT02812342|OG000|Outcome|Tofacitinib Ointment|"Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.~Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth."
11280977|NCT02812342|EG000|Reported Event|Tofacitinib Ointment|"Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.~Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth."
11280978|NCT02812771|BG000|Baseline|Efinaconazole|"Efinaconazole~Efinaconazole: Solution"
11280979|NCT02812771|FG000|Participant Flow|Efinaconazole|"Efinaconazole~Efinaconazole: Solution"
11280980|NCT02812771|OG000|Outcome|Efinaconazole|"Efinaconazole~Efinaconazole: Solution"
11280981|NCT02812771|EG000|Reported Event|Efinaconazole|"Efinaconazole~Efinaconazole: Solution"
11280982|NCT02813070|BG000|Baseline|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280983|NCT02813070|BG001|Baseline|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280984|NCT02813070|BG002|Baseline|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280985|NCT02813070|BG003|Baseline|Total|Total of all reporting groups
11280986|NCT02813070|FG000|Participant Flow|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of probable Alzheimer's disease (pAD), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent Positron emission tomography (PET) imaging.
11280987|NCT02813070|FG001|Participant Flow|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of amnestic mild cognitive impairment (aMCI), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280988|NCT02813070|FG002|Participant Flow|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280989|NCT02813070|OG000|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280990|NCT02813070|OG001|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280991|NCT02813070|EG000|Reported Event|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280992|NCT02813070|EG001|Reported Event|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280993|NCT02813070|EG002|Reported Event|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
11280994|NCT02813265|BG000|Baseline|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11280995|NCT02813265|BG001|Baseline|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11280996|NCT02813265|BG002|Baseline|Total|Total of all reporting groups
11280997|NCT02813265|FG000|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11280998|NCT02813265|FG001|Participant Flow|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11280999|NCT02813265|OG000|Outcome|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281000|NCT02813265|OG001|Outcome|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281001|NCT02813265|EG000|Reported Event|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281002|NCT02813265|EG001|Reported Event|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281003|NCT02813421|BG000|Baseline|CGM Informed|"CGM data was available for use when determining starting insulin pump doses.~CGM Informed"
11281004|NCT02813421|BG001|Baseline|Control|CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
11281005|NCT02813421|BG002|Baseline|Total|Total of all reporting groups
11281006|NCT02813421|FG000|Participant Flow|CGM Informed|"CGM data was available for use when determining starting insulin pump doses.~CGM Informed"
11281007|NCT02813421|FG001|Participant Flow|Control|CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
11281008|NCT02813421|OG000|Outcome|CGM Informed|"CGM data was available for use when determining starting insulin pump doses.~CGM Informed"
11281009|NCT02813421|OG001|Outcome|Control|CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
11281010|NCT02813421|EG000|Reported Event|CGM Informed|"CGM data was available for use when determining starting insulin pump doses.~CGM Informed"
11281011|NCT02813421|EG001|Reported Event|Control|CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
11281012|NCT02813473|BG000|Baseline|Patients With Left Main or 3 Vessel Artery Disease|Patients with left main or three-vessel coronary artery disease, diagnosed with either coronary CTA or conventional angiography and candidates for either CABG or PCI.
11281013|NCT02813473|FG000|Participant Flow|Patients With Left Main or 3 Vessel Artery Disease|"223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an Angio-First or a CT-First decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint."
11281014|NCT02813473|OG000|Outcome|Patients With Left Main or 3 Vessel Artery Disease|"223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an Angio-First or a CT-First decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint."
11281015|NCT02813473|EG000|Reported Event|Patients With Left Main or 3 Vessel Artery Disease|Patients with left main or three-vessel coronary artery disease, diagnosed with either coronary CTA or conventional angiography and candidates for either CABG or PCI.
11281016|NCT02813551|BG000|Baseline|Torsemide|Torsemide 20 mg daily for 5 days
11281017|NCT02813551|BG001|Baseline|Placebo|Placebo 20 mg daily for 5 days
11281018|NCT02813551|BG002|Baseline|Total|Total of all reporting groups
11281019|NCT02813551|FG000|Participant Flow|Torsemide|Torsemide 20 mg daily for 5 days
11281020|NCT02813551|FG001|Participant Flow|Placebo|Placebo 20 mg daily for 5 days
11281021|NCT02813551|OG000|Outcome|Torsemide|Torsemide 20 mg daily for 5 days
11281022|NCT02813551|OG001|Outcome|Placebo|Placebo 20 mg daily for 5 days
11281023|NCT02813551|EG000|Reported Event|Torsemide|Torsemide 20 mg daily for 5 days
11281024|NCT02813551|EG001|Reported Event|Placebo|Placebo 20 mg daily for 5 days
11281025|NCT02813577|BG000|Baseline|Lutonix® 035 Drug Coated Balloon PTA Catheter|"This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.~Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter."
11281026|NCT02813577|FG000|Participant Flow|Lutonix® 035 Drug Coated Balloon PTA Catheter|"This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.~Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter."
11281027|NCT02813577|OG000|Outcome|Lutonix® 035 Drug Coated Balloon PTA Catheter|"This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.~Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter."
11281028|NCT02813577|EG000|Reported Event|Lutonix® 035 Drug Coated Balloon PTA Catheter|"This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.~Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter."
11281029|NCT02813681|BG000|Baseline|US-epidural SVD|"US-epidural SVD group- participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity~US-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281030|NCT02813681|BG001|Baseline|(US Sham- Epidural SVD)|"US sham- epidural SVD group - participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the participant to their group status (US epidural or US sham epidural).~US sham- epidural SVD: participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281031|NCT02813681|BG002|Baseline|Spontaneous Vaginal Delivery Without an Epidural|"Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural).~The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet"
11281032|NCT02813681|BG003|Baseline|Total|Total of all reporting groups
11287071|NCT02897115|BG001|Baseline|Standard of Care (SOC)|Participants received treatment as prescribed by their physician according to the local standard of care.
11287072|NCT02897115|BG002|Baseline|Total|Total of all reporting groups
11281033|NCT02813681|FG000|Participant Flow|US-epidural SVD|"Group 1: (US-epidural SVD) - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity~US-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281034|NCT02813681|FG001|Participant Flow|(US Sham- Epidural SVD)|"Group 2: (US sham- epidural SVD) - participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the participant to their group status (US epidural or US sham epidural).~US sham- epidural SVD: participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281035|NCT02813681|FG002|Participant Flow|Spontaneous Vaginal Delivery Without an Epidural|"Group 5: Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural).~Spontaneous vaginal delivery without an Epidural: Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet any of the exclusion requirements~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281036|NCT02813681|OG000|Outcome|US-epidural SVD|"US-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity~US-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281037|NCT02813681|OG001|Outcome|(US Sham- Epidural SVD)|"US sham- epidural SVD group- participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the participant to their group status (US epidural or US sham epidural).~US sham- epidural SVD: participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281038|NCT02813681|OG002|Outcome|Spontaneous Vaginal Delivery Without an Epidural|"Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural).~Spontaneous vaginal delivery without an Epidural: Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet any of the exclusion requirements~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281039|NCT02813681|OG001|Outcome|(US Sham- Epidural SVD)|"US sham- epidural SVD group - participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the participant to their group status (US epidural or US sham epidural).~US sham- epidural SVD: participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281040|NCT02813681|OG002|Outcome|Spontaneous Vaginal Delivery Without an Epidural|"Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural).~The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet"
11281041|NCT02813681|EG000|Reported Event|US-epidural SVD|"Group 1: (US-epidural SVD) - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity~US-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281042|NCT02813681|EG001|Reported Event|(US Sham- Epidural SVD)|"Group 2: (US sham- epidural SVD) - participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the participant to their group status (US epidural or US sham epidural).~US sham- epidural SVD: participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).~Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold."
11281043|NCT02813681|EG002|Reported Event|Spontaneous Vaginal Delivery Without an Epidural|"Group 5: Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural).~The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet"
11281044|NCT02813694|BG000|Baseline|Lefamulin|oral lefamulin, 600mg
11281045|NCT02813694|BG001|Baseline|Moxifloxacin|oral moxifloxacin, 400mg
11281046|NCT02813694|BG002|Baseline|Total|Total of all reporting groups
11281047|NCT02813694|FG000|Participant Flow|Lefamulin|oral lefamulin, 600mg
11281048|NCT02813694|FG001|Participant Flow|Moxifloxacin|oral moxifloxacin, 400mg
11281049|NCT02813694|OG000|Outcome|Lefamulin|oral lefamulin, 600mg
11281050|NCT02813694|OG001|Outcome|Moxifloxacin|oral moxifloxacin, 400mg
11281051|NCT02813694|EG000|Reported Event|Lefamulin|oral lefamulin, 600mg
11281052|NCT02813694|EG001|Reported Event|Moxifloxacin|oral moxifloxacin, 400mg
11281053|NCT02814175|BG000|Baseline|Part 1: MTX Escalated Dose|Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
11281054|NCT02814175|BG001|Baseline|Part 1: ADA + MTX|Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew)
11281055|NCT02814175|BG002|Baseline|Total|Total of all reporting groups
11281056|NCT02814175|FG000|Participant Flow|Part 1: MTX Escalated Dose|Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
11281057|NCT02814175|FG001|Participant Flow|Part 1: ADA + MTX|Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew)
11281058|NCT02814175|FG002|Participant Flow|Part 2: MTX Escalated Dose|Participants achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 -25 mg or highest tolerable dose every week (ew), continued with the same MTX dose
11281059|NCT02814175|FG003|Participant Flow|Part 2: ADA +MTX Escalated Dose|Participants not achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew), received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew
11281060|NCT02814175|FG004|Participant Flow|Part 2: ADA|Participants achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
11281061|NCT02814175|FG005|Participant Flow|Part 2: ADA ew + MTX|Participants not achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
11281062|NCT02814175|OG000|Outcome|Part 1: MTX Escalated Dose|Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
11281063|NCT02814175|OG001|Outcome|Part 1: ADA + MTX|Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
11281064|NCT02814175|OG000|Outcome|Part 2: MTX Escalated Dose|Participants achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 -25 mg or highest tolerable dose every week (ew), continued with the same MTX dose
11281065|NCT02814175|OG001|Outcome|Part 2: ADA + MTX Escalated Dose|Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew
11281066|NCT02814175|OG002|Outcome|Part 2: ADA|Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
11281067|NCT02814175|OG003|Outcome|Part 2: ADA ew + MTX|Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
11281068|NCT02814175|EG000|Reported Event|Part 1: MTX Escalated Dose|Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) (MTX 20 - 25 mg or highest tolerable dose ew)
11281069|NCT02814175|EG001|Reported Event|Part 1: ADA + MTX|Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew (ADA 40 mg eow + MTX 15 mg ew
11281070|NCT02814175|EG002|Reported Event|Part 2: MTX Escalated Dose|Participants achieving MDA at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose (MTX 20 - 25 mg or highest tolerable dose ew)
11281071|NCT02814175|EG003|Reported Event|Part 2: ADA + MTX Escalated Dose|Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew (ADA 40 mg eow plus MTX 20 - 25 mg or highest tolerable dose ew)
11281072|NCT02814175|EG004|Reported Event|Part 2: ADA|Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy (ADA 40 mg eow),
11281073|NCT02814175|EG005|Reported Event|Part 2: ADA ew + MTX|Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew (ADA 40 mg ew plus MTX 15 mg ew)
11281074|NCT02814227|BG000|Baseline|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
11281075|NCT02814227|FG000|Participant Flow|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
11281076|NCT02814227|OG000|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
11281077|NCT02814227|EG000|Reported Event|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography~Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
11281078|NCT02814279|BG000|Baseline|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281079|NCT02814279|BG001|Baseline|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281080|NCT02814279|BG002|Baseline|Total|Total of all reporting groups
11281081|NCT02814279|FG000|Participant Flow|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281082|NCT02814279|FG001|Participant Flow|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281083|NCT02814279|OG000|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281084|NCT02814279|OG001|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11287073|NCT02897115|FG000|Participant Flow|Treat-to-Target (T2T)|Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
11281085|NCT02814279|EG000|Reported Event|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281086|NCT02814279|EG001|Reported Event|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
11281087|NCT02814448|BG000|Baseline|CO2 Standard Cryotherapy- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281088|NCT02814448|BG001|Baseline|CO2 Standard Cryotherapy- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281089|NCT02814448|BG002|Baseline|CryoPen- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281090|NCT02814448|BG003|Baseline|CryoPen- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281091|NCT02814448|BG004|Baseline|Thermocoagulator|"Single heat application at 100 ºC for 40 seconds~Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues"
11281092|NCT02814448|BG005|Baseline|Total|Total of all reporting groups
11281093|NCT02814448|FG000|Participant Flow|CO2 Standard Cryotherapy- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281094|NCT02814448|FG001|Participant Flow|CO2 Standard Cryotherapy- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281095|NCT02814448|FG002|Participant Flow|CryoPen- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281096|NCT02814448|FG003|Participant Flow|CryoPen- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281097|NCT02814448|FG004|Participant Flow|Thermocoagulator|"Single heat application at 100 ºC for 40 seconds~Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues"
11281098|NCT02814448|OG000|Outcome|CO2 Standard Cryotherapy- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281099|NCT02814448|OG001|Outcome|CO2 Standard Cryotherapy- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281100|NCT02814448|OG002|Outcome|CryoPen- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281101|NCT02814448|OG003|Outcome|CryoPen- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281102|NCT02814448|OG004|Outcome|Thermocoagulator|"Single heat application at 100 ºC for 40 seconds~Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues"
11281103|NCT02814448|EG000|Reported Event|CO2 Standard Cryotherapy- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281104|NCT02814448|EG001|Reported Event|CO2 Standard Cryotherapy- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue"
11281105|NCT02814448|EG002|Reported Event|CryoPen- Double Freeze|"Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281106|NCT02814448|EG003|Reported Event|CryoPen- Single Freeze|"Single freeze treatment consists of one five-minute freeze~CryoPen: Provides a means of freezing tissue without the use of gases or liquids"
11281107|NCT02814448|EG004|Reported Event|Thermocoagulator|"Single heat application at 100 ºC for 40 seconds~Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues"
11281108|NCT02814565|BG000|Baseline|Cyclobenzaprine HCl 15 mg|Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
11281109|NCT02814565|BG001|Baseline|Placebo|Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
11281110|NCT02814565|BG002|Baseline|Total|Total of all reporting groups
11281111|NCT02814565|FG000|Participant Flow|Cyclobenzaprine HCl 15 mg|Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
11281112|NCT02814565|FG001|Participant Flow|Placebo|Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
11281113|NCT02814565|OG000|Outcome|Cyclobenzaprine HCl 15 mg|Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
11281114|NCT02814565|OG001|Outcome|Placebo|Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
11281115|NCT02814565|EG000|Reported Event|Cyclobenzaprine HCl 15 mg|Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
11281116|NCT02814565|EG001|Reported Event|Placebo|Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
11281117|NCT02814643|BG000|Baseline|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
11281118|NCT02814643|BG001|Baseline|Placebo|Placebo to benralizumab subcutaneous
11281119|NCT02814643|BG002|Baseline|Total|Total of all reporting groups
11281120|NCT02814643|FG000|Participant Flow|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
11281121|NCT02814643|FG001|Participant Flow|Placebo|Placebo to benralizumab subcutaneous
11281122|NCT02814643|OG000|Outcome|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
11281123|NCT02814643|OG001|Outcome|Placebo|Placebo to benralizumab subcutaneous
11281124|NCT02814643|EG000|Reported Event|Benralizumab 30mg|Benralizumab 30mg/day subcutaneous
11281125|NCT02814643|EG001|Reported Event|Placebo|Placebo to benralizumab subcutaneous
11281126|NCT02814656|BG000|Baseline|300 μg AZD8871|Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
11281127|NCT02814656|BG001|Baseline|600 μg AZD8871|Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281128|NCT02814656|BG002|Baseline|900 μg AZD8871|Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281129|NCT02814656|BG003|Baseline|Placebo|Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
11281130|NCT02814656|BG004|Baseline|Total|Total of all reporting groups
11281131|NCT02814656|FG000|Participant Flow|300 μg AZD8871|Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
11281132|NCT02814656|FG001|Participant Flow|600 μg AZD8871|Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281133|NCT02814656|FG002|Participant Flow|900 μg AZD8871|Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281134|NCT02814656|FG003|Participant Flow|Placebo|Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
11281135|NCT02814656|OG000|Outcome|300 μg AZD8871|Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
11281136|NCT02814656|OG001|Outcome|600 μg AZD8871|Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281137|NCT02814656|OG002|Outcome|900 μg AZD8871|Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281138|NCT02814656|OG003|Outcome|Placebo|Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
11281139|NCT02814656|EG000|Reported Event|300 μg AZD8871|Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
11281140|NCT02814656|EG001|Reported Event|600 μg AZD8871|Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281141|NCT02814656|EG002|Reported Event|900 μg AZD8871|Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
11281142|NCT02814656|EG003|Reported Event|Placebo|Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
11281143|NCT02814838|BG000|Baseline|Ladarixin|"Ladarixin oral capsule~Ladarixin: Ladarixin oral capsule"
11281144|NCT02814838|BG001|Baseline|Placebo|"Placebo oral capsule~Placebo: Placebo oral capsule"
11281145|NCT02814838|BG002|Baseline|Total|Total of all reporting groups
11281146|NCT02814838|FG000|Participant Flow|Ladarixin|"Ladarixin oral capsule~Ladarixin: Ladarixin oral capsule"
11281147|NCT02814838|FG001|Participant Flow|Placebo|"Placebo oral capsule~Placebo: Placebo oral capsule"
11281148|NCT02814838|OG000|Outcome|Ladarixin|"Ladarixin oral capsule~Ladarixin: Ladarixin oral capsule"
11281149|NCT02814838|OG001|Outcome|Placebo|"Placebo oral capsule~Placebo: Placebo oral capsule"
11281150|NCT02814838|EG000|Reported Event|Ladarixin|"Ladarixin oral capsule~Ladarixin: Ladarixin oral capsule"
11281151|NCT02814838|EG001|Reported Event|Placebo|"Placebo oral capsule~Placebo: Placebo oral capsule"
11281152|NCT02814890|BG000|Baseline|Group RD(Ropivacaine and Dexmedetomidine)|"Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.~Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.~Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.~There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia)."
11281153|NCT02814890|BG001|Baseline|Group R(Ropivacaine Only)|"Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.~Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.~Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.~There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia)."
11281154|NCT02814890|BG002|Baseline|Total|Total of all reporting groups
11287074|NCT02897115|FG001|Participant Flow|Standard of Care (SOC)|Participants received treatment as prescribed by their physician according to the local standard of care.
11281155|NCT02814890|FG000|Participant Flow|Group RD(Ropivacaine and Dexmedetomidine)|"Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.~Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.~Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.~Sixty-five patients were initially recruited. Five patients were excluded from present study, including 3 patients in group RD who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions."
11281156|NCT02814890|FG001|Participant Flow|Group R(Ropivacaine Only)|"Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.~Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.~Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.~Sixty-five patients were initially recruited. Five patients were excluded from present study, including 2 patients in group R who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions."
11281157|NCT02814890|OG000|Outcome|Group RD(Ropivacaine and Dexmedetomidine)|The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
11281158|NCT02814890|OG001|Outcome|Group R(Ropivacaine Only)|The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
11281159|NCT02814890|OG000|Outcome|Group RD(Ropivacaine and Dexmedetomidine)|Patients' satisfaction were assessed verbally 48 hours after surgery using a 5- point Likert scale (5=completely satisfied, 4=quite satisfied, 3=slightly dissatisfied, 2=dissatisfied, 1=very dissatisfied).
11281160|NCT02814890|OG001|Outcome|Group R(Ropivacaine Only)|Patients' satisfaction were assessed verbally 48 hours after surgery using a 5- point Likert scale (5=completely satisfied, 4=quite satisfied, 3=slightly dissatisfied, 2=dissatisfied, 1=very dissatisfied).
11281161|NCT02814890|OG000|Outcome|Group RD(Ropivacaine and Dexmedetomidine)|An extra rescue analgesic morphine 5 mg was given when the NRS was ≥ 4 at rest. The time of the first rescue analgesic requirement and the total morphine consumption in the first 48 hours were recorded.
11281162|NCT02814890|OG001|Outcome|Group R(Ropivacaine Only)|An extra rescue analgesic morphine 5 mg was given when the NRS was ≥ 4 at rest. The time of the first rescue analgesic requirement and the total morphine consumption in the first 48 hours were recorded.
11281163|NCT02814890|OG000|Outcome|Group RD(Ropivacaine and Dexmedetomidine)|Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
11281164|NCT02814890|OG001|Outcome|Group R(Ropivacaine Only)|Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
11281165|NCT02814890|EG000|Reported Event|Group RD(Ropivacaine and Dexmedetomidine)|Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
11281166|NCT02814890|EG001|Reported Event|Group R(Ropivacaine Only)|Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
11281167|NCT02815293|BG000|Baseline|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11281168|NCT02815293|BG001|Baseline|Vehicle|One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11281169|NCT02815293|BG002|Baseline|Enrolled But Not Randomized|Run-In period before randomization
11281170|NCT02815293|BG003|Baseline|Total|Total of all reporting groups
11281171|NCT02815293|FG000|Participant Flow|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11281172|NCT02815293|FG001|Participant Flow|Vehicle|One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11281173|NCT02815293|FG002|Participant Flow|Enrolled But Not Randomized|Run-In period before randomization
11281174|NCT02815293|OG000|Outcome|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11281175|NCT02815293|OG001|Outcome|Vehicle|One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11281176|NCT02815293|EG000|Reported Event|AGN-195263|One drop of 0.1% AGN-195263 instilled in each eye twice daily
11281177|NCT02815293|EG001|Reported Event|Vehicle|One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
11281178|NCT02815644|BG000|Baseline|Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 1: Fed-Fasted)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after a standard Japanese breakfast in period 1 and after an overnight fast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281179|NCT02815644|BG001|Baseline|Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 2: Fasted-Fed)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after an overnight fast in period 1 and after a standard Japanese breakfast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281180|NCT02815644|BG002|Baseline|Total|Total of all reporting groups
11281181|NCT02815644|FG000|Participant Flow|Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 1: Fed-Fasted)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after a standard Japanese breakfast in period 1 and after an overnight fast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281182|NCT02815644|FG001|Participant Flow|Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 2: Fasted-Fed)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after an overnight fast in period 1 and after a standard Japanese breakfast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281183|NCT02815644|OG000|Outcome|Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281184|NCT02815644|OG001|Outcome|Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281185|NCT02815644|EG000|Reported Event|Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281186|NCT02815644|EG001|Reported Event|Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)|Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
11281187|NCT02815670|BG000|Baseline|Idarucizumab|2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period.
11281188|NCT02815670|FG000|Participant Flow|Idarucizumab|2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period.
11281189|NCT02815670|OG000|Outcome|Idarucizumab|2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period.
11281190|NCT02815670|EG000|Reported Event|Idarucizumab|2.5 gram (g) per 50 milliliter (mL) vial of Idarucizuma was administrated via intravenous injection (vial 1) with (in order of preference): a 5 minutes (min) infusion with an infusion pump, a 10 to 15 min drip, or intravenous push with a syringe followed by another injection (vial 2) of same dosage of Idarucizumab for participants who were treated with dabigatran and had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention or who required emergency surgery/urgent procedures where adequate haemostasis was required (total dosage: up to 5g based on the weight of participant). Two equal injection parts were administered no more than 15 min apart. The time between start of injection of the first vial and end of the second vial was 22 min followed by 24 hours post-dose observation period.
11281191|NCT02815709|BG000|Baseline|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281192|NCT02815709|BG001|Baseline|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281193|NCT02815709|BG002|Baseline|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281194|NCT02815709|BG003|Baseline|Placebo|Placebo
11281195|NCT02815709|BG004|Baseline|Morphine|Morphine
11281196|NCT02815709|BG005|Baseline|Total|Total of all reporting groups
11281197|NCT02815709|FG000|Participant Flow|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281198|NCT02815709|FG001|Participant Flow|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281199|NCT02815709|FG002|Participant Flow|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281200|NCT02815709|FG003|Participant Flow|Placebo|Placebo
11281201|NCT02815709|FG004|Participant Flow|Morphine|Morphine
11281202|NCT02815709|OG000|Outcome|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281203|NCT02815709|OG001|Outcome|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281204|NCT02815709|OG002|Outcome|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281205|NCT02815709|OG003|Outcome|Placebo|Placebo
11281206|NCT02815709|OG004|Outcome|Morphine|Morphine
11281207|NCT02815709|OG001|Outcome|Treatment 2 Oliceridine|Oliceridine 0.35
11281208|NCT02815709|EG000|Reported Event|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281209|NCT02815709|EG001|Reported Event|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281210|NCT02815709|EG002|Reported Event|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281211|NCT02815709|EG003|Reported Event|Placebo|Placebo
11281212|NCT02815709|EG004|Reported Event|Morphine|Morphine
11281213|NCT02815735|BG000|Baseline|Overall Participants|"Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
11281214|NCT02815735|FG000|Participant Flow|Comfilcon A, Then Lotrafilcon B|"Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
11281215|NCT02815735|FG001|Participant Flow|Lotrafilcon B, Then Comfilcon A|"Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens~comfilcon A: contact lens"
11281216|NCT02815735|OG000|Outcome|Habitual (Baseline)|Habitual data assessed at baseline.
11281217|NCT02815735|OG001|Outcome|Comfilcon A (2 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281218|NCT02815735|OG002|Outcome|Lotrafilcon B (2 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281219|NCT02815735|OG003|Outcome|Comfilcon A (4 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281220|NCT02815735|OG004|Outcome|Lotrafilcon B (4 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281221|NCT02815735|OG000|Outcome|Comfilcon A (Day 3)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281222|NCT02815735|OG001|Outcome|Lotrafilcon B (Day 3)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281223|NCT02815735|OG002|Outcome|Comfilcon A (Day 12)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281224|NCT02815735|OG003|Outcome|Lotrafilcon B (Day 12)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281225|NCT02815735|OG004|Outcome|Comfilcon A (Day 26)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281226|NCT02815735|OG005|Outcome|Lotrafilcon B (Day 26)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281227|NCT02815735|EG000|Reported Event|Comfilcon A|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
11281228|NCT02815735|EG001|Reported Event|Lotrafilcon B|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
11281229|NCT02815982|BG000|Baseline|NOURISH-T - Caregivers|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child.~NOURISH-T: Overweight/obesity family intervention"
11281230|NCT02815982|BG001|Baseline|NOURISH-T - Pediatric Cancer Survivors (PCS)|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child.~NOURISH-T: Overweight/obesity family intervention"
11281231|NCT02815982|BG002|Baseline|Enhanced Usual Care - Caregivers|"Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281232|NCT02815982|BG003|Baseline|Enhanced Usual Care - Pediatric Cancer Survivors (PCS)|"Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281233|NCT02815982|BG004|Baseline|Total|Total of all reporting groups
11281234|NCT02815982|FG000|Participant Flow|NOURISH-T - Caregivers|"Participants consisted of caregivers of obese pediatric cancer survivors (PCS). PCS are assessed at each time point (baseline, post intervention and 4 months follow-up), but do not directly participate in the intervention. NOURISH-T intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child. Different measures are administered to caregivers and PCS.~NOURISH-T: Overweight/obesity family intervention"
11281235|NCT02815982|FG001|Participant Flow|Enhanced Usual Care - Caregivers|"Participants consisted of caregivers of obese pediatric cancer survivors (PCS). PCS are assessed but do not directly participate in the EUC group. randomized to the EUC attend assessment sessions and an initial session moderated by an independent interventionist. The session addresses the role of diet and exercise in pediatric overweight. In addition, EUC caregivers receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants also receive a booster phone call 2 months after the end of the intervention period. Different measures are administered to caregivers and PCS.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281236|NCT02815982|FG002|Participant Flow|NOURISH-T - Pediatric Cancer Survivors (PCS)|PCS are recruited with their caregivers, but do not participate in the intervention. PCS only complete measures.
11281237|NCT02815982|FG003|Participant Flow|Enhanced Usual Care - Pediatric Cancer Survivors (PCS)|PCS are recruited with their caregivers, but do not participate in the intervention (EUC), they only complete measures at each time point.
11281238|NCT02815982|OG000|Outcome|NOURISH-T|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child. PCS are assessed, but do not directly participate in the intervention.~NOURISH-T: Overweight/obesity family intervention"
11281239|NCT02815982|OG001|Outcome|Enhanced Usual Care|"Caregivers randomized to the enhanced usual care will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Caregivers also receive a booster phone call 2 months after the end of the intervention period. PCS are assessed, but do not directly participate in the intervention.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281240|NCT02815982|OG000|Outcome|NOURISH-T|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child.~NOURISH-T: Overweight/obesity family intervention"
11281241|NCT02815982|OG001|Outcome|Enhanced Usual Care (EUC)|"Caregivers randomized to the enhanced usual care will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281242|NCT02815982|OG001|Outcome|Enhanced Usual Care|"Caregivers randomized to the enhanced usual care will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281243|NCT02815982|OG001|Outcome|Enhanced Usual Care(EUC)|"Caregivers randomized to the enhanced usual care will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281244|NCT02815982|EG000|Reported Event|NOURISH-T - Caregivers|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child.~NOURISH-T: Overweight/obesity family intervention"
11281245|NCT02815982|EG001|Reported Event|Enhanced Usual Care - Caregivers|"Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11281246|NCT02815982|EG002|Reported Event|NOURISH-T - Pediatric Cancer Survivors (PCS)|"The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the identified patient or overweight child.~NOURISH-T: Overweight/obesity family intervention"
11287075|NCT02897115|OG000|Outcome|Treat-to-Target (T2T)|Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
11281247|NCT02815982|EG003|Reported Event|Enhanced Usual Care - Pediatric Cancer Survivors (PCS)|"Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period.~Enhanced Usual Care: Publicly available overweight/obesity materials"
11287076|NCT02897115|OG001|Outcome|Standard of Care (SOC)|Participants received treatment as prescribed by their physician according to the local standard of care.
11287077|NCT02897115|EG000|Reported Event|Standard of Care (SOC)|Participants received treatment as prescribed by their physician according to the local standard of care.
11287078|NCT02897115|EG001|Reported Event|Treat-to-Target (T2T)|Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
11287079|NCT02897141|BG000|Baseline|mVIP Group|"This group will receive targeted symptom strategies from the UCSF symptom management manual based on the symptoms that they report.~Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual."
11287080|NCT02897141|BG001|Baseline|Attention Control Group|"This group will have the Health Management App without symptom strategies pre-loaded on their smartphones.~Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies"
11287081|NCT02897141|BG002|Baseline|Total|Total of all reporting groups
11287082|NCT02897141|FG000|Participant Flow|mVIP Group|"This group will receive targeted symptom strategies from the University of California, San Francisco (UCSF) symptom management manual based on the symptoms that they report.~Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual."
11287083|NCT02897141|FG001|Participant Flow|Attention Control Group|"This group will have the Health Management App without symptom strategies pre-loaded on their smartphones.~Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies"
11287084|NCT02897141|OG000|Outcome|Intervention|Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.
11287085|NCT02897141|OG001|Outcome|Control|Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.
11287086|NCT02897141|OG002|Outcome|Difference Between Groups|This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
11287087|NCT02897141|OG000|Outcome|Intervention|mVIP App participants
11287088|NCT02897141|OG001|Outcome|Control|Control App participants
11287089|NCT02897141|OG000|Outcome|Intervention Arm|Participants received the mVIP App
11287090|NCT02897141|OG001|Outcome|Control Arm|Participants received the control app
11287091|NCT02897141|OG000|Outcome|Intervention Arm|Participants received the mVIP App.
11287092|NCT02897141|OG001|Outcome|Control Arm|Participants received a control app
11287093|NCT02897141|OG000|Outcome|Intervention|Participants who received the mVIP app
11287094|NCT02897141|OG001|Outcome|Control Arm|Participants who received the Control App
11287095|NCT02897141|OG000|Outcome|Intervention Arm|Participants who received the mVIP app
11287096|NCT02897141|OG001|Outcome|Control Arm|Participants who received the control app
11287097|NCT02897141|EG000|Reported Event|mVIP Group|"This group will receive targeted symptom strategies from the UCSF symptom management manual based on the symptoms that they report.~Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual."
11287098|NCT02897141|EG001|Reported Event|Attention Control Group|"This group will have the Health Management App without symptom strategies pre-loaded on their smartphones.~Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies"
11287099|NCT02897349|BG000|Baseline|Placebo Matching Linagliptin|Participants were administered placebo matching 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287100|NCT02897349|BG001|Baseline|Linagliptin|Participants were administered 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287101|NCT02897349|BG002|Baseline|Total|Total of all reporting groups
11287102|NCT02897349|FG000|Participant Flow|Placebo Matching Linagliptin|Participants were administered placebo matching 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287103|NCT02897349|FG001|Participant Flow|Linagliptin|Participants were administered 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287104|NCT02897349|OG000|Outcome|Placebo Matching Linagliptin|Participants were administered placebo matching 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287105|NCT02897349|OG001|Outcome|Linagliptin|Participants were administered 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11281248|NCT02816138|BG000|Baseline|Transdermal Nicotine Patch|"Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.~Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.~Nicotine: Open-label transdermal nicotine patch"
11281249|NCT02816138|FG000|Participant Flow|Transdermal Nicotine Patch|"Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.~Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.~Nicotine: Open-label transdermal nicotine patch"
11281250|NCT02816138|OG000|Outcome|Transdermal Nicotine Patch|"Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.~Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.~Nicotine: Open-label transdermal nicotine patch"
11281251|NCT02816138|EG000|Reported Event|Transdermal Nicotine Patch|"Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.~Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.~Nicotine: Open-label transdermal nicotine patch"
11281252|NCT02816346|BG000|Baseline|Cohort 1|"Received 500 colony-forming units (CFU) of Shigella sonnei 53G.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281253|NCT02816346|BG001|Baseline|Cohort 2|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 1 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281254|NCT02816346|BG002|Baseline|Cohort 3|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 2 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281255|NCT02816346|BG003|Baseline|Cohort 4|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 3 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281256|NCT02816346|BG004|Baseline|Cohort 5|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 4 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281257|NCT02816346|BG005|Baseline|Total|Total of all reporting groups
11281258|NCT02816346|FG000|Participant Flow|Cohort 1: S. Sonnei 53G Target Dose 500 CFU|"Shigella sonnei 53G: Investigational Product: One dose of Shigella sonnei rehydrated challenge strain 53G (Lot 1794) suspension in 2 mL of cold sterile water combined and diluted in cold, sterile normal saline 0.9% (i.e. challenge suspension).~Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 5 minutes.~Target Dose: 500cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281259|NCT02816346|FG001|Participant Flow|Cohort 2: S. Sonnei 53G Target Dose 1000 CFU|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 1 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: One dose of Shigella sonnei rehydrated challenge strain 53G (Lot 1794) suspension in 2 mL of cold sterile water combined and diluted in cold, sterile normal saline 0.9% (i.e. challenge suspension).~Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 5 minutes.~Dose: 1000 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281260|NCT02816346|FG002|Participant Flow|Cohort 3: S. Sonnei 53G Target Dose of 1000 CFU|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 2 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: One dose of Shigella sonnei rehydrated challenge strain 53G (Lot 1794) suspension in 2 mL of cold sterile water combined and diluted in cold, sterile normal saline 0.9% (i.e. challenge suspension).~Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 5 minutes.~Dose: 1000 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281261|NCT02816346|FG003|Participant Flow|Cohort 4: S. Sonnei 53G Target Dose 1500 CFU|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 3 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: One dose of Shigella sonnei rehydrated challenge strain 53G (Lot 1794) suspension in 2 mL of cold sterile water combined and diluted in cold, sterile normal saline 0.9% (i.e. challenge suspension).~Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 5 minutes.~Dose: 1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11287106|NCT02897349|EG000|Reported Event|Placebo Matching Linagliptin|Participants were administered placebo matching 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11287107|NCT02897349|EG001|Reported Event|Linagliptin|Participants were administered 5 milligram (mg) linagliptin tablet once daily per os (p.o.) for 24 weeks.
11281262|NCT02816346|FG004|Participant Flow|Cohort 5: S. Sonnei 53G Target Dose 1150 CFU|"Received higher dose of Shigella sonnei 53G if ≥ 60% of subjects in Cohort 4 experienced shigellosis, or lower dose if not.~Shigella sonnei 53G: Investigational Product: One dose of Shigella sonnei rehydrated challenge strain 53G (Lot 1794) suspension in 2 mL of cold sterile water combined and diluted in cold, sterile normal saline 0.9% (i.e. challenge suspension).~Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 5 minutes.~Dose: 1150 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281263|NCT02816346|OG000|Outcome|Cohort 1|"Received target dose of 500 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 510, 717, 588, and 567 CFU).~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281264|NCT02816346|OG001|Outcome|Cohort 2|"Received target dose of 1000 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 817 CFU), since the attack rate of shigellosis for Cohort 1 was below the protocol target of 60%.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281265|NCT02816346|OG002|Outcome|Cohort 3|"Received target dose of 1000 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 913 CFU. Although the target dose was the same as Cohort 2, the safety monitoring committee felt that the per-protocol a priori definition of shigellosis was too restrictive and that increasing the dose above 1000 CFU may lead to unnecessarily high toxicity.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281266|NCT02816346|OG003|Outcome|Cohort 4|"Received target dose of 1500 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 1760 CFU) since the attack rate of shigellosis for Cohort 2 and 3 was below the protocol target of 60%.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281267|NCT02816346|OG004|Outcome|Cohort 5|"Received target dose of 1150 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 1760 CFU) as the final confirmatory cohort since it was felt that the disease rate and profile of Cohort 4 was appropriate.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281268|NCT02816346|EG000|Reported Event|Cohort 1|"Received target dose of 500 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 510, 717, 588, and 567 CFU).~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281269|NCT02816346|EG001|Reported Event|Cohort 2|"Received target dose of 1000 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 817 CFU), since the attack rate of shigellosis for Cohort 1 was below the protocol target of 60%.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281270|NCT02816346|EG002|Reported Event|Cohort 3|"Received target dose of 1000 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 913 CFU. Although the target dose was the same as Cohort 2, the safety monitoring committee felt that the per-protocol a priori definition of shigellosis was too restrictive and that increasing the dose above 1000 CFU may lead to unnecessarily high toxicity.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281271|NCT02816346|EG003|Reported Event|Cohort 4|"Received target dose of 1500 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 1760 CFU) since the attack rate of shigellosis for Cohort 2 and 3 was below the protocol target of 60%.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281272|NCT02816346|EG004|Reported Event|Cohort 5|"Received target dose of 1150 colony-forming units (CFU) of Shigella sonnei 53G (actual dose: 1760 CFU) as the final confirmatory cohort since it was felt that the disease rate and profile of Cohort 4 was appropriate.~Shigella sonnei 53G: Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
11281273|NCT02816398|BG000|Baseline|Treatment|"Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula~Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula"
11281274|NCT02816398|FG000|Participant Flow|Treatment|"Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula~Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula"
11281275|NCT02816398|OG000|Outcome|Treatment|"Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula~Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula"
11281276|NCT02816398|EG000|Reported Event|Treatment|"Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula~Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula"
11287108|NCT02898103|BG000|Baseline|Active Then Sham Then Active|electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes, then sham for 5 minutes, then active current for 2-4 weeks
11281277|NCT02816710|BG000|Baseline|IVC Preoperative Group|"Conbercept injection before vitrectomy~Conbercept: Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists."
11281278|NCT02816710|BG001|Baseline|IVC Postoperative Group|"Conbercept injection at the end of vitrectomy~Conbercept: Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists."
11281279|NCT02816710|BG002|Baseline|IVC Pre- and Post-operative Group|"First conbercept injection before vitrectomy and second at the end of operation.~Conbercept: Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists."
11281280|NCT02816710|BG003|Baseline|Total|Total of all reporting groups
11281281|NCT02816710|FG000|Participant Flow|IVC Preoperative Group|Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
11281282|NCT02816710|FG001|Participant Flow|IVC Postoperative Group|Patients in this group received an IVC injection at the end of surgery.
11281283|NCT02816710|FG002|Participant Flow|IVC Pre- and Post-operative Group|Patients in this group received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of pars plana vitrectomy (PPV).
11281284|NCT02816710|OG000|Outcome|IVC Preoperative Group|Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
11281285|NCT02816710|OG001|Outcome|IVC Postoperative Group|Patients in this group received an IVC injection at the end of surgery.
11281286|NCT02816710|OG002|Outcome|IVC Pre- and Post-operative Group|Patients in this group received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV.
11281287|NCT02816710|OG000|Outcome|Group 1|Group 1 received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
11281288|NCT02816710|OG001|Outcome|Group 2|Group 2 received an IVC injection at the end of surgery.
11281289|NCT02816710|OG002|Outcome|Group 3|Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV.
11281290|NCT02816710|EG000|Reported Event|IVC Preoperative Group|Patients in this group received an intravitreal conbercept (IVC) injection 3 to 5 days before surgery.
11281291|NCT02816710|EG001|Reported Event|IVC Postoperative Group|Patients in this group received an IVC injection at the end of surgery.
11281292|NCT02816710|EG002|Reported Event|IVC Pre- and Post-operative Group|Patients in this group received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV.
11281293|NCT02816723|BG000|Baseline|Mindfulness|Mindfulness-based Stress Reduction (MBSR): The MBSR group meets once per week for 2½ hours, with a day-long retreat in the 6th week of the 8-week program. Participants are instructed in mindfulness practice in the form of sitting meditation, body awareness, yoga, mindful movement, and informal mindfulness practices of daily life (e.g., eating, communicating, working, coping). The day-long retreat includes a review of class material, more lengthy meditation and yoga practice, as well as a group lunch. Between classes, patients enhance their participation by practicing at home with meditation CDs, homework assignments, and readings from the course materials and manual. Home practice is tracked with pre-made log sheets on which participants record the number of hours engaged in practice at home.
11281294|NCT02816723|BG001|Baseline|Brain Health|"Brain Health education class:~The Brain Health class is matched for the same number of hours, instructor, schedule (including day-long retreat), homework, and home practice as that of the MBSR class. The class provides background and education about brain-behavior relationships and discusses how brain injuries can disrupt various aspects of cognition, such as memory and attention. There are also units on nutrition and sleep, including strategies for successful aging. To control for the yoga/movement portion of the MBSR class, the Brain Health class also includes simple chair exercises, such as stretching and reaching. The day-long retreat includes review of class topics, video documentaries on these topics, and a group lunch. The Brain Health class matches MBSR intervention for critical process elements such as clinician interaction, social interaction with the group, movement, schedule, and homework activities, without the inclusion of a meditative/mindfulness component."
11281295|NCT02816723|BG002|Baseline|Total|Total of all reporting groups
11281296|NCT02816723|FG000|Participant Flow|Mindfulness|Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
11281297|NCT02816723|FG001|Participant Flow|Brain Health|"Brain Health education class~Brain Health: Brain Health Education"
11281298|NCT02816723|OG000|Outcome|Mindfulness|Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
11281299|NCT02816723|OG001|Outcome|Brain Health|"Brain Health education class~Brain Health: Brain Health Education"
11281300|NCT02816723|EG000|Reported Event|Mindfulness|Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
11281301|NCT02816723|EG001|Reported Event|Brain Health|"Brain Health education class~Brain Health: Brain Health Education"
11281302|NCT02817087|BG000|Baseline|Repetitive Transcranial Magnetic Stimulation -On|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.~repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain"
11281303|NCT02817087|BG001|Baseline|Repetitive Transcranial Magnetic Stimulation -Off|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.~repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment."
11281304|NCT02817087|BG002|Baseline|Total|Total of all reporting groups
11281305|NCT02817087|FG000|Participant Flow|Repetitive Transcranial Magnetic Stimulation -On|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.~repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain"
11281306|NCT02817087|FG001|Participant Flow|Repetitive Transcranial Magnetic Stimulation -Off|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.~repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment."
11281307|NCT02817087|OG000|Outcome|Repetitive Transcranial Magnetic Stimulation -On|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.~repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain"
11281308|NCT02817087|OG001|Outcome|Repetitive Transcranial Magnetic Stimulation -Off|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.~repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment."
11281309|NCT02817087|EG000|Reported Event|Repetitive Transcranial Magnetic Stimulation -On|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.~repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain"
11281310|NCT02817087|EG001|Reported Event|Repetitive Transcranial Magnetic Stimulation -Off|"Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.~repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment."
11281311|NCT02817516|BG000|Baseline|Part 1 Cohorts 1 to 3: Placebo|TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281312|NCT02817516|BG001|Baseline|Part 1 Cohort 1: TAK-828 15 mg|TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281313|NCT02817516|BG002|Baseline|Part 1 Cohort 2: TAK-828 45 mg|TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281314|NCT02817516|BG003|Baseline|Part 1 Cohort 3: TAK-828 75 mg|TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281315|NCT02817516|BG004|Baseline|Total|Total of all reporting groups
11281316|NCT02817516|FG000|Participant Flow|Part 1 Cohorts 1 to 3: Placebo|TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281317|NCT02817516|FG001|Participant Flow|Part 1 Cohort 1: TAK-828 15 mg|TAK-828 15 mg, solution (0.2 milligram per milliliter [mg/mL] or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281318|NCT02817516|FG002|Participant Flow|Part 1 Cohort 2: TAK-828 45 mg|TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281319|NCT02817516|FG003|Participant Flow|Part 1 Cohort 3: TAK-828 75 mg|TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281320|NCT02817516|OG000|Outcome|Part 1 Cohorts 1 to 3: Placebo|TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281321|NCT02817516|OG001|Outcome|Part 1 Cohort 1: TAK-828 15 mg|TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281322|NCT02817516|OG002|Outcome|Part 1 Cohort 2: TAK-828 45 mg|TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281323|NCT02817516|OG003|Outcome|Part 1 Cohort 3: TAK-828 75 mg|TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281324|NCT02817516|OG000|Outcome|Part 1 Cohort 1: TAK-828 15 mg|TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281325|NCT02817516|OG001|Outcome|Part 1 Cohort 2: TAK-828 45 mg|TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281326|NCT02817516|OG002|Outcome|Part 1 Cohort 3: TAK-828 75 mg|TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281327|NCT02817516|EG000|Reported Event|Part 1 Cohorts 1 to 3: Placebo|TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281328|NCT02817516|EG001|Reported Event|Part 1 Cohort 1: TAK-828 15 mg|TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281329|NCT02817516|EG002|Reported Event|Part 1 Cohort 2: TAK-828 45 mg|TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11281330|NCT02817516|EG003|Reported Event|Part 1 Cohort 3: TAK-828 75 mg|TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
11287109|NCT02898103|BG001|Baseline|Sham Then Active Electrical Current|sham will be given for 5 minutes followed by active current for 2-4 weeks
11287110|NCT02898103|BG002|Baseline|Total|Total of all reporting groups
11281331|NCT02817555|BG000|Baseline|Epoetin Alfa|"Patients who are enrolled and randomized to the Epoetin arm will remain on their current dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used. The subjects will remain on epoetin for the required run-in phase followed by the 12 month active phase.~The investigator will adjust epoetin doses as per the study algorithm during the run-in and active phases. This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.~All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.~It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher.~Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate."
11281332|NCT02817555|BG001|Baseline|Darbepoetin Alfa|"Patients who are randomized to the Darbepoetin arm will have their epoetin and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin.~Switching patients will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded to the nearest pre-filled syringe available from the manufacturer.~After the first Hb measurement the study algorithm will be used.~The investigator will adjust darbepoetin doses as per the study algorithm during the run-in and active phases. This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.~All darbepoetin will be administered intravenously through a hemodialysis machine port.~It is not anticipated that a subject will require a dose of darbepoetin >150µg weekly. If this occurs the dose will not be escalated any higher.~Intravenous iron will be given as per the study algorithm, sodium ferric gluconate."
11281333|NCT02817555|BG002|Baseline|Total|Total of all reporting groups
11281334|NCT02817555|FG000|Participant Flow|Epoetin Alfa|"Patients who are enrolled and randomized to the Epoetin arm will remain on their pre-enrollment dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.~Epoetin Alfa: The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.~All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.~It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal."
11281335|NCT02817555|FG001|Participant Flow|Darbepoetin Alfa|"Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin.~Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer.~After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.~Darbepoetin alfa: The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study."
11281336|NCT02817555|OG000|Outcome|Epoetin Alfa|"Patients who are enrolled and randomized to the Epoetin arm will remain on their current dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.~Epoetin Alfa: The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.~All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.~It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal.~Intravenous iron will be given as per the"
11281337|NCT02817555|OG001|Outcome|Darbepoetin Alfa|"Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin.~Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer.~After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.~Darbepoetin alfa: The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study."
11281338|NCT02817555|EG000|Reported Event|Epoetin Alfa|"Patients who are enrolled and randomized to the Epoetin arm will remain on their pre-enrollment dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.~Epoetin Alfa: The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.~All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.~It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal."
11287111|NCT02898103|FG000|Participant Flow|Active Then Sham Then Active|electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes, then sham for 5 minutes, then active current for 2-4 weeks
11281339|NCT02817555|EG001|Reported Event|Darbepoetin Alfa|"Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin.~Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer.~After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.~Darbepoetin alfa: The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study."
11281340|NCT02817594|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.
11281341|NCT02817594|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|"Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.~The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study."
11281342|NCT02817594|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
11281343|NCT02817594|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin|Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.
11281344|NCT02817594|EG000|Reported Event|2 DAA|Participants received paritaprevir/ritonavir and ombitasvir for 12 weeks.
11281345|NCT02817594|EG001|Reported Event|2 DAA + RBV|Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks.
11281346|NCT02817594|EG002|Reported Event|3 DAA|Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir, without ribavirin, for 12 weeks.
11281347|NCT02817594|EG003|Reported Event|3 DAA + RBV|Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir plus ribavirin for 12 weeks.
11281348|NCT02817763|BG000|Baseline|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281349|NCT02817763|BG001|Baseline|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281350|NCT02817763|BG002|Baseline|Total|Total of all reporting groups
11281351|NCT02817763|FG000|Participant Flow|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281352|NCT02817763|FG001|Participant Flow|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281353|NCT02817763|OG000|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11287112|NCT02898103|FG001|Participant Flow|Sham Then Active Electrical Current|sham will be given for 5 minutes followed by active current for 2-4 weeks
11281354|NCT02817763|OG001|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281355|NCT02817763|EG000|Reported Event|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281356|NCT02817763|EG001|Reported Event|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
11281357|NCT02817776|BG000|Baseline|Treatment Group|Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
11281358|NCT02817776|FG000|Participant Flow|Treatment Group|Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
11281359|NCT02817776|OG000|Outcome|Treatment Group|Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
11281360|NCT02817776|EG000|Reported Event|Treatment Group|Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
11281361|NCT02817828|BG000|Baseline|15 mg E4/3 mg DRSP|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
10970528|NCT00910858|EG001|Reported Event|15 mg Lenalidomide|"Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
11281362|NCT02817828|FG000|Participant Flow|15 mg E4/3 mg DRSP|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281363|NCT02817828|OG000|Outcome|15 mg E4/3 mg DRSP|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281364|NCT02817828|OG000|Outcome|15 mg E4/3 mg DRSP - Baseline Results|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281365|NCT02817828|OG001|Outcome|15 mg E4/3 mg DRSP - End of Treatment Results|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281366|NCT02817828|OG000|Outcome|15 mg E4/3 mg DRSP Tablet - Menstrual Phase|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281367|NCT02817828|OG001|Outcome|15 mg E4/3 mg DRSP Tablet - Premenstrual Phase|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281368|NCT02817828|OG002|Outcome|15 mg E4/3 mg DRSP Tablet - Intermenstrual Phase|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281369|NCT02817828|EG000|Reported Event|15 mg E4/3 mg DRSP|"15 mg E4/3 mg DRSP tablet~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered orally once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281370|NCT02817841|BG000|Baseline|15 mg E4/3 mg DRSP|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281371|NCT02817841|FG000|Participant Flow|15 mg E4/3 mg DRSP|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281372|NCT02817841|OG000|Outcome|15 mg E4/3 mg DRSP|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281373|NCT02817841|OG000|Outcome|15 mg E4/3 mg DRSP - RP1|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281374|NCT02817841|OG000|Outcome|15 mg E4/3 mg DRSP - Intermenstrual Phase|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281375|NCT02817841|OG001|Outcome|15 mg E4/3 mg DRSP - Premenstrual Phase|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281376|NCT02817841|OG002|Outcome|15 mg E4/3 mg DRSP - Menstrual Phase|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281377|NCT02817841|EG000|Reported Event|15 mg E4/3 mg DRSP|"15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive~15 mg E4/3 mg DRSP: 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days."
11281378|NCT02817906|BG000|Baseline|9 mg ITI-007|9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
11281379|NCT02817906|BG001|Baseline|Placebo|Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
11281380|NCT02817906|BG002|Baseline|Total|Total of all reporting groups
11281381|NCT02817906|FG000|Participant Flow|ITI-007 9 mg|"9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.~ITI-007(lumateperone tosylate) 9 mg is equivalent to 6 mg lumateperone, the free base or active moiety."
11281382|NCT02817906|FG001|Participant Flow|Placebo|Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
11281383|NCT02817906|OG000|Outcome|9 mg ITI-007|9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
11281384|NCT02817906|OG001|Outcome|Placebo|Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
11281385|NCT02817906|EG000|Reported Event|9 mg ITI-007|9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
11281386|NCT02817906|EG001|Reported Event|Placebo|Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
11281387|NCT02818036|BG000|Baseline|Naltrexone|"single 50mg dose of naltrexone~Naltrexone"
11281388|NCT02818036|BG001|Baseline|Sugar Pill|"single sugar pill~Placebo"
11281389|NCT02818036|BG002|Baseline|Total|Total of all reporting groups
11281390|NCT02818036|FG000|Participant Flow|Naltrexone|"single 50mg dose of naltrexone~Naltrexone"
11281391|NCT02818036|FG001|Participant Flow|Sugar Pill|"single sugar pill~Placebo"
11281392|NCT02818036|OG000|Outcome|Naltrexone|"single 50mg dose of naltrexone~Naltrexone"
11281393|NCT02818036|OG001|Outcome|Sugar Pill|"single sugar pill~Placebo"
11281394|NCT02818036|EG000|Reported Event|Naltrexone|"single 50mg dose of naltrexone~Naltrexone"
11281395|NCT02818036|EG001|Reported Event|Sugar Pill|"single sugar pill~Placebo"
11281396|NCT02818114|BG000|Baseline|PEET|Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure
11281397|NCT02818114|FG000|Participant Flow|Peer Enhanced Exposure Therapy (PEET)|Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to Prolonged Exposure
11281398|NCT02818114|OG000|Outcome|Peer Enhanced Prolonged Exposure|Standard Prolonged Exposure therapy supplemented by weekly, manualized peer support sessions.
11281399|NCT02818114|OG000|Outcome|PEET|Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure
11281400|NCT02818114|EG000|Reported Event|PEET|Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure
11281401|NCT02818244|BG000|Baseline|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281402|NCT02818244|BG001|Baseline|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281403|NCT02818244|BG002|Baseline|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281404|NCT02818244|BG003|Baseline|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281405|NCT02818244|BG004|Baseline|Total|Total of all reporting groups
11281406|NCT02818244|FG000|Participant Flow|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281407|NCT02818244|FG001|Participant Flow|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281408|NCT02818244|FG002|Participant Flow|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281409|NCT02818244|FG003|Participant Flow|Apple Watch|Apple Watch Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281410|NCT02818244|OG000|Outcome|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281411|NCT02818244|OG001|Outcome|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281412|NCT02818244|OG002|Outcome|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281413|NCT02818244|OG003|Outcome|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281414|NCT02818244|EG000|Reported Event|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281415|NCT02818244|EG001|Reported Event|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281416|NCT02818244|EG002|Reported Event|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281417|NCT02818244|EG003|Reported Event|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
11281418|NCT02818569|BG000|Baseline|All Study Participants|All study participants who were either randomized to receive either Oral Dexmedetomidine or the placebo comparator initially.
11281419|NCT02818569|FG000|Participant Flow|Oral Dexmedetomidine, Then Placebo|This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.
11281420|NCT02818569|FG001|Participant Flow|Placebo, Then Oral Dexmedetomidine|This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine.
11281421|NCT02818569|OG000|Outcome|Oral Dexmedetomidine|"Dexmedetomidine~Type: Oral"
11281422|NCT02818569|OG001|Outcome|Placebo Comparator|"Placebo Comparator~Type: Saline"
11281423|NCT02818569|OG000|Outcome|Oral Dexmedetomidine|Oral Dexmedetomidine
11281424|NCT02818569|OG001|Outcome|Placebo Comparator|"Saline~Saline Placebo: Saline Placebo"
11281425|NCT02818569|OG000|Outcome|Experimental|"Oral Dexmedetomidine~Dexmedetomidine: Oral form"
11281426|NCT02818569|EG000|Reported Event|Experimental|"Oral Dexmedetomidine~Dexmedetomidine: Oral form"
11281427|NCT02818569|EG001|Reported Event|Placebo Comparator|"Saline~Saline Placebo: Saline Placebo"
11281428|NCT02818777|BG000|Baseline|Cannabidiol|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day.~cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281429|NCT02818777|FG000|Participant Flow|Cannabidiol|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day.~cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281430|NCT02818777|OG000|Outcome|Cannabidiol 5 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 5 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281431|NCT02818777|OG001|Outcome|Cannabidiol 7.5 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 7.5 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11337688|NCT03591146|FG000|Participant Flow|TLC590 190mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11281432|NCT02818777|OG002|Outcome|Cannabidiol 10 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 10 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281433|NCT02818777|OG003|Outcome|Cannabidiol 15 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 15 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281434|NCT02818777|OG004|Outcome|Cannabidiol 20 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 20 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281435|NCT02818777|OG005|Outcome|Cannabidiol 25 mg/kg/Day|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Dosage: 25 mg/kg/day cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281436|NCT02818777|OG000|Outcome|Cannabidiol|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day.~cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281437|NCT02818777|EG000|Reported Event|Cannabidiol|"GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring).~Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day.~cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
11281438|NCT02818998|BG000|Baseline|Aflibercept 2 mg Fixed|Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
11281439|NCT02818998|BG001|Baseline|Aflibercept 2 mg Extended|Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
11281440|NCT02818998|BG002|Baseline|Aflibercept 2 mg PRN|Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
11281441|NCT02818998|BG003|Baseline|Total|Total of all reporting groups
11281442|NCT02818998|FG000|Participant Flow|Aflibercept 2 mg Fixed|Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
11281443|NCT02818998|FG001|Participant Flow|Aflibercept 2 mg Extended|Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
11281444|NCT02818998|FG002|Participant Flow|Aflibercept 2 mg PRN|Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
11281445|NCT02818998|OG000|Outcome|Aflibercept 2 mg Fixed|Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
11281446|NCT02818998|OG001|Outcome|Aflibercept 2 mg Extended|Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
11281447|NCT02818998|OG002|Outcome|Aflibercept 2 mg PRN|Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
11281448|NCT02818998|EG000|Reported Event|Aflibercept 2 mg Fixed|Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
11281449|NCT02818998|EG001|Reported Event|Aflibercept 2 mg Extended|Participants received flexible dosing of 2 mg aflibercept at injection intervals of >=8 week
11281450|NCT02818998|EG002|Reported Event|Aflibercept 2 mg PRN|Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
11281451|NCT02819011|BG000|Baseline|Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.~Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)"
11281452|NCT02819011|BG001|Baseline|No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes for the duration of the study.~Control: Subjects will be provided with a pair of New Balance 813 shoes"
11281453|NCT02819011|BG002|Baseline|Total|Total of all reporting groups
11281454|NCT02819011|FG000|Participant Flow|Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.~Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)"
11281455|NCT02819011|FG001|Participant Flow|No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes for the duration of the study.~Control: Subjects will be provided with a pair of New Balance 813 shoes"
11281456|NCT02819011|OG000|Outcome|Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.~Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)"
11281457|NCT02819011|OG001|Outcome|No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes for the duration of the study.~Control: Subjects will be provided with a pair of New Balance 813 shoes"
11281458|NCT02819011|OG000|Outcome|Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.~Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) : Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)"
11281459|NCT02819011|EG000|Reported Event|Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.~Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)"
11281460|NCT02819011|EG001|Reported Event|No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group|"This group will be provided with a pair of New Balance 813 shoes for the duration of the study.~Control: Subjects will be provided with a pair of New Balance 813 shoes"
11281461|NCT02819284|BG000|Baseline|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281462|NCT02819284|BG001|Baseline|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281463|NCT02819284|BG002|Baseline|Total|Total of all reporting groups
11281464|NCT02819284|FG000|Participant Flow|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281465|NCT02819284|FG001|Participant Flow|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281466|NCT02819284|OG000|Outcome|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281467|NCT02819284|OG001|Outcome|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281468|NCT02819284|EG000|Reported Event|KPI-121 0.25% Ophthalmic Suspension|Participants randomized to KPI-121 0.25% Ophthalmic Suspension
11281469|NCT02819284|EG001|Reported Event|Vehicle of KPI-121 0.25% Ophthalmic Suspension|Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
11281470|NCT02819297|BG000|Baseline|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder)
11281471|NCT02819297|BG001|Baseline|Placebo|BLI400 placebo (equivalent amount of placebo powder)
11281472|NCT02819297|BG002|Baseline|Total|Total of all reporting groups
11281473|NCT02819297|FG000|Participant Flow|BLI400 Laxative|BLI400 Laxative (21 gm of BLI400 powder)
11281474|NCT02819297|FG001|Participant Flow|Placebo|BLI400 placebo (equivalent amount of placebo powder)
11281475|NCT02819297|OG000|Outcome|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder)
11281476|NCT02819297|OG001|Outcome|Placebo|BLI400 placebo (equivalent amount of placebo powder)
11281477|NCT02819297|EG000|Reported Event|BLI400 Laxative|BLI400 Laxative (21 gm BLI400 powder)
11281478|NCT02819297|EG001|Reported Event|Placebo|BLI400 placebo (equivalent amount of placebo powder)
11281479|NCT02819310|BG000|Baseline|BLI400 Laxative|"BLI400 Laxative~BLI400 Laxative: oral laxative"
11281480|NCT02819310|FG000|Participant Flow|BLI400 Laxative|"BLI400 Laxative~BLI400 Laxative: oral laxative"
11281481|NCT02819310|OG000|Outcome|BLI400 Laxative|"BLI400 Laxative~BLI400 Laxative: oral laxative"
11281482|NCT02819310|EG000|Reported Event|BLI400 Laxative|"BLI400 Laxative~BLI400 Laxative: oral laxative"
11281483|NCT02819323|BG000|Baseline|BLI800 High Dose|"BLI800 bowel preparation (high dose)~BLI800: BLI800 bowel preparation (6 oz)"
11281484|NCT02819323|BG001|Baseline|BLI800 Low Dose|"BLI800 bowel preparation (low dose)~BLI800: BLI800 bowel preparation (4.5 oz)"
11281485|NCT02819323|BG002|Baseline|PEG-ELS|"PEG based bowel preparation~PEG-ELS: polyethylene glycol based bowel preparation"
11281486|NCT02819323|BG003|Baseline|Total|Total of all reporting groups
11281487|NCT02819323|FG000|Participant Flow|BLI800 High Dose|"BLI800 bowel preparation (high dose)~BLI800: BLI800 bowel preparation (6 oz)"
11281488|NCT02819323|FG001|Participant Flow|BLI800 Low Dose|"BLI800 bowel preparation (low dose)~BLI800: BLI800 bowel preparation (4.5 oz)"
11281489|NCT02819323|FG002|Participant Flow|PEG-ELS|"PEG based bowel preparation~PEG-ELS: polyethylene glycol based bowel preparation"
11281490|NCT02819323|OG000|Outcome|BLI800 High Dose|"BLI800 bowel preparation (high dose)~BLI800: BLI800 bowel preparation (6 oz)"
11281491|NCT02819323|OG001|Outcome|BLI800 Low Dose|"BLI800 bowel preparation (low dose)~BLI800: BLI800 bowel preparation (4.5 oz)"
11281492|NCT02819323|OG002|Outcome|PEG-ELS|"PEG based bowel preparation~PEG-ELS: polyethylene glycol based bowel preparation"
11281493|NCT02819323|EG000|Reported Event|BLI800 High Dose|"BLI800 bowel preparation (high dose)~BLI800: BLI800 bowel preparation (6 oz)"
11281494|NCT02819323|EG001|Reported Event|BLI800 Low Dose|"BLI800 bowel preparation (low dose)~BLI800: BLI800 bowel preparation (4.5 oz)"
11281495|NCT02819323|EG002|Reported Event|PEG-ELS|"PEG based bowel preparation~PEG-ELS: polyethylene glycol based bowel preparation"
11281496|NCT02819557|BG000|Baseline|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening (for a total of 40 mg/kg/day) for up to 52 weeks. Dose was provided based upon the weight of each participant, which was assessed every 12 weeks.
11281497|NCT02819557|FG000|Participant Flow|Ataluren|Participants were administered ataluren orally at a dose of 10 milligrams/kilograms (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening (for a total of 40 mg/kg/day) for up to 52 weeks. Dose was provided based upon the weight of each participant, which was assessed every 12 weeks.
11281498|NCT02819557|OG000|Outcome|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening (for a total of 40 mg/kg/day) for up to 52 weeks. Dose was provided based upon the weight of each participant, which was assessed every 12 weeks.
11281499|NCT02819557|EG000|Reported Event|Ataluren|Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening (for a total of 40 mg/kg/day) for up to 52 weeks. Dose was provided based upon the weight of each participant, which was assessed every 12 weeks.
11281500|NCT02819726|BG000|Baseline|SAIT101|SAIT101: 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible participants.
11281501|NCT02819726|BG001|Baseline|MabThera|MabThera: 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible participants.
11281502|NCT02819726|BG002|Baseline|Rituxan|Rituxan: 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible participants.
11281503|NCT02819726|BG003|Baseline|Total|Total of all reporting groups
11281504|NCT02819726|FG000|Participant Flow|SAIT101 (Part A and B)|1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
11281505|NCT02819726|FG001|Participant Flow|MabThera (Part A and B)|1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.
11281506|NCT02819726|FG002|Participant Flow|Rituxan (Part A and B)|1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
11281507|NCT02819726|FG003|Participant Flow|SAIT101 (Part B Only)|1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
11281508|NCT02819726|OG000|Outcome|SAIT101|1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
11281509|NCT02819726|OG001|Outcome|MabThera|1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.
11281510|NCT02819726|OG002|Outcome|Rituxan|1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
11281511|NCT02819726|EG000|Reported Event|SAIT101|SAIT101: 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible participants.
11281512|NCT02819726|EG001|Reported Event|MabThera|MabThera: 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible participants.
11281513|NCT02819726|EG002|Reported Event|Rituxan|Rituxan: 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible participants.
11281514|NCT02819973|BG000|Baseline|Racially Concordant Video|Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant.
11281515|NCT02819973|BG001|Baseline|Racially Discordant Video|Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant
11281516|NCT02819973|BG002|Baseline|Usual Care (no Video)|Standard Care/ No video
11281517|NCT02819973|BG003|Baseline|Total|Total of all reporting groups
11281518|NCT02819973|FG000|Participant Flow|Racially Concordant Video|Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant
11281519|NCT02819973|FG001|Participant Flow|Racially Discordant Video|Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant.
11281520|NCT02819973|FG002|Participant Flow|Usual Care (No Video)|Standard Care/ No video
11281521|NCT02819973|OG000|Outcome|Video|Participants randomized to watch a video about ICDs
11281522|NCT02819973|OG001|Outcome|Usual Care (no Video)|Participants randomized to usual care with no video
11281523|NCT02819973|OG000|Outcome|Racially Concordant Video|Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant.
11281524|NCT02819973|OG001|Outcome|Racially Discordant Video|Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant.
11281525|NCT02819973|OG000|Outcome|Video|Participants randomized to watch a video about ICDs.
11281526|NCT02819973|OG001|Outcome|Usual Care (no Video)|Participants randomized to receive usual care with no video
11281527|NCT02819973|OG001|Outcome|Usual Care (no Video)|Participants randomized to usual care with no video.
11281528|NCT02819973|OG000|Outcome|Video|Participants watching a video about ICDs.
11281529|NCT02819973|OG001|Outcome|Usual Care (no Video)|Participants not watching a video about ICDs.
11281530|NCT02819973|EG000|Reported Event|Educational Video 1|"African American/ Black Video~Educational Video1"
11281531|NCT02819973|EG001|Reported Event|Educational Video 2|"Caucasian Video~Educational Video 2"
11281532|NCT02819973|EG002|Reported Event|Usual Care (no Video) 3|"Standard Care/ No video~Usual Care 3"
11281533|NCT02820038|BG000|Baseline|Other CMI Only|Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.
11281534|NCT02820038|BG001|Baseline|Other CMI & SMART Program|"Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281535|NCT02820038|BG002|Baseline|Drug Facts Boxes Only|Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.
11281536|NCT02820038|BG003|Baseline|Drug Facts Boxes & SMART Program|"Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281537|NCT02820038|BG004|Baseline|Total|Total of all reporting groups
11281538|NCT02820038|FG000|Participant Flow|Other CMI Only|Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.
11281539|NCT02820038|FG001|Participant Flow|Other CMI & SMART Program|"Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281540|NCT02820038|FG002|Participant Flow|Drug Facts Boxes Only|Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.
11092379|NCT01539525|FG000|Participant Flow|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11281541|NCT02820038|FG003|Participant Flow|Drug Facts Boxes & SMART Program|"Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281542|NCT02820038|OG000|Outcome|Other CMI Only|Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.
11281543|NCT02820038|OG001|Outcome|Other CMI & SMART Program|"Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281544|NCT02820038|OG002|Outcome|Drug Facts Boxes Only|Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.
11281545|NCT02820038|OG003|Outcome|Drug Facts Boxes & SMART Program|"Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281546|NCT02820038|OG001|Outcome|Other CMI & SMART Program|"Participants were given Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281547|NCT02820038|EG000|Reported Event|Other CMI Only|Participants were given access to Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.
11281548|NCT02820038|EG001|Reported Event|Other CMI & SMART Program|"Participants were given Medication Guides, mandated by the Food and Drug Administration for many medications used to treat rheumatoid arthritis, or comparable consumer medication information for medications without a mandated medication guide.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281549|NCT02820038|EG002|Reported Event|Drug Facts Boxes Only|Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.
11281550|NCT02820038|EG003|Reported Event|Drug Facts Boxes & SMART Program|"Participants were given access to medication information in the Drug Facts Box format developed by Woloshin and Schwartz.~Participants were also invited to participate in gist reasoning training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information."
11281551|NCT02820181|BG000|Baseline|Novel Tracheostomy Bi-ties|"those with the novel tracheostomy bi-ties~novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate."
11281552|NCT02820181|BG001|Baseline|Traditional Tracheostomy Tie|"those with traditional tracheostomy tie~traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands."
11281553|NCT02820181|BG002|Baseline|Total|Total of all reporting groups
11281554|NCT02820181|FG000|Participant Flow|Novel Tracheostomy Bi-ties|"those with the novel tracheostomy bi-ties~novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate."
11281555|NCT02820181|FG001|Participant Flow|Traditional Tracheostomy Tie|"those with traditional tracheostomy tie~traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands."
11281556|NCT02820181|OG000|Outcome|Novel Tracheostomy Bi-ties|"those with the novel tracheostomy bi-ties~novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate."
11281557|NCT02820181|OG001|Outcome|Traditional Tracheostomy Tie|"those with traditional tracheostomy tie~traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands."
11281558|NCT02820181|EG000|Reported Event|Novel Tracheostomy Bi-ties|"those with the novel tracheostomy bi-ties~novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate."
11281559|NCT02820181|EG001|Reported Event|Traditional Tracheostomy Tie|"those with traditional tracheostomy tie~traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands."
11281560|NCT02820298|BG000|Baseline|Bexagliflozin Administered in Fed Condition, Then in Fasted Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 and a second dose of bexagliflozin tablet in fasted state on day 8.
11281561|NCT02820298|BG001|Baseline|Bexagliflozin Administered in Fasted Condition, Then in Fed Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted state on day 1 and second dose of bexagliflozin tablet with a high-fat meal on day 8
11281562|NCT02820298|BG002|Baseline|Total|Total of all reporting groups
11281563|NCT02820298|FG000|Participant Flow|Bexagliflozin Administered in Fed Condition, Then in Fasted Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 and a second dose of bexagliflozin tablet in fasted state on day 8.
11281564|NCT02820298|FG001|Participant Flow|Bexagliflozin Administered in Fasted Condition, Then in Fed Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted state on day 1 and second dose of bexagliflozin tablet with a high-fat meal on day 8
11281565|NCT02820298|OG000|Outcome|Bexagliflozin Tablet Dosed in Fed Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
11281566|NCT02820298|OG001|Outcome|Bexagliflozin Tablet Dosed in Fasted Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
11281567|NCT02820298|OG000|Outcome|Bexagliflozin Tablet Dosed in Fed Condition|Subjects were dosed with bexagliflozin tablet with a high-fat meal
11281568|NCT02820298|OG001|Outcome|Bexagliflozin Tablet Dosed in Fasted Condition|Subjects were dosed with bexagliflozin tablet in fasted condition
11281569|NCT02820298|OG000|Outcome|Bexagliflozin Tablet Dosed in Fed Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal after an overnight fast.
11281570|NCT02820298|OG001|Outcome|Bexagliflozin Dosed in Fasted Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted condition.
11281571|NCT02820298|OG000|Outcome|Bexagliflozin Tablet Dosed in Fed Condition|Group 1 subjects will take one dose of bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
11281572|NCT02820298|OG001|Outcome|Bexagliflozin Dosed in Fasted Condition|Group 2 subjects will take one dose of bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
11281573|NCT02820298|EG000|Reported Event|Bexagliflozin Tablet Dosed in Fed Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal after an overnight fast
11281574|NCT02820298|EG001|Reported Event|Bexagliflozin Tablet Dosed in Fasted Condition|Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted condition after an overnight fast
11281575|NCT02820324|BG000|Baseline|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281576|NCT02820324|BG001|Baseline|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281577|NCT02820324|BG002|Baseline|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281578|NCT02820324|BG003|Baseline|Treatment 4 Placebo|Placebo
11281579|NCT02820324|BG004|Baseline|Treatment 5 Morphine|Morphine
11281580|NCT02820324|BG005|Baseline|Total|Total of all reporting groups
11281581|NCT02820324|FG000|Participant Flow|Treatment 1 Oliceridine|"Oliceridine 0.1 mg~The loading dose was 1.5 mg with PCA demand doses of 0.1 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens."
11281582|NCT02820324|FG001|Participant Flow|Treatment 2 Oliceridine|"Oliceridine 0.35 mg~The loading dose was 1.5 mg with PCA demand doses of 0.35 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens."
11281583|NCT02820324|FG002|Participant Flow|Treatment 3 Oliceridine|"Oliceridine 0.5 mg~The loading dose was 1.5 mg with PCA demand doses of 0.5 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens."
11281584|NCT02820324|FG003|Participant Flow|Treatment 4 Placebo|"Placebo~The loading dose was 1.5 mL with volume-matched PCA demand doses. Supplemental doses of 0.75 mL were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens."
11281585|NCT02820324|FG004|Participant Flow|Treatment 5 Morphine|"Morphine~The loading dose for the morphine treatment regimen was 4 mg with 1 mg demand doses. Supplemental doses of 2 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens."
11281586|NCT02820324|OG000|Outcome|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281587|NCT02820324|OG001|Outcome|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281588|NCT02820324|OG002|Outcome|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281589|NCT02820324|OG003|Outcome|Treatment 4 Placebo|Placebo
11281590|NCT02820324|OG004|Outcome|Treatment 5 Morphine|Morphine
11281591|NCT02820324|EG000|Reported Event|Treatment 1 Oliceridine|Oliceridine 0.1 mg
11281592|NCT02820324|EG001|Reported Event|Treatment 2 Oliceridine|Oliceridine 0.35 mg
11281593|NCT02820324|EG002|Reported Event|Treatment 3 Oliceridine|Oliceridine 0.5 mg
11281594|NCT02820324|EG003|Reported Event|Treatment 4 Placebo|Placebo
11281595|NCT02820324|EG004|Reported Event|Treatment 5 Morphine|Morphine
11281596|NCT02820597|BG000|Baseline|Intervention|"Treatment with the ClariFix Device~ClariFix Device"
11281597|NCT02820597|FG000|Participant Flow|Intervention|Cryoablation with the ClariFix device
11281598|NCT02820597|OG000|Outcome|Intervention|Cryoablation with the ClariFix device
11281599|NCT02820597|EG000|Reported Event|Intervention|"Treatment with the ClariFix Device~ClariFix Device"
11281600|NCT02820844|BG000|Baseline|Placebo|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 milliliter [mL] each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.
11281601|NCT02820844|BG001|Baseline|GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.
11281602|NCT02820844|BG002|Baseline|Total|Total of all reporting groups
11281603|NCT02820844|FG000|Participant Flow|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281604|NCT02820844|FG001|Participant Flow|Treatment Cycle 1: GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281605|NCT02820844|FG002|Participant Flow|Treatment Cycle 2: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2).
11281606|NCT02820844|FG003|Participant Flow|Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).
11281607|NCT02820844|FG004|Participant Flow|Treatment Cycle 3: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
11281608|NCT02820844|FG005|Participant Flow|Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
11281609|NCT02820844|OG000|Outcome|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281610|NCT02820844|OG001|Outcome|Treatment Cycle 1: GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281611|NCT02820844|OG000|Outcome|Treatment Cycle 2: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 2).
11281612|NCT02820844|OG001|Outcome|Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) until Week 36 after the first treatment.
11281613|NCT02820844|OG000|Outcome|Treatment Cycle 3: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
10970529|NCT00910871|BG000|Baseline|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
10970530|NCT00910871|FG000|Participant Flow|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
10970531|NCT00910871|OG000|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
11281614|NCT02820844|OG001|Outcome|Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 3) until Week 36 after the first treatment.
11281615|NCT02820844|OG000|Outcome|Treatment Cycle 3 Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
11281616|NCT02820844|OG000|Outcome|Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) until Week 36 after the first treatment.
11281617|NCT02820844|OG000|Outcome|Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 3) until Week 36 after the first treatment.
11281618|NCT02820844|EG000|Reported Event|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281619|NCT02820844|EG001|Reported Event|Treatment Cycle 1: GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11281620|NCT02820844|EG002|Reported Event|Treatment Cycle 2: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 2).
11281621|NCT02820844|EG003|Reported Event|Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) until Week 36 after the first treatment.
11281622|NCT02820844|EG004|Reported Event|Treatment Cycle 3: Placebo / GSK1358820 100 U|Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
11281623|NCT02820844|EG005|Reported Event|Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U|Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 3) until Week 36 after the first treatment.
11281624|NCT02820870|BG000|Baseline|Primary Care Intervention Group|"Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines.~Statin Decision Support Intervention: The investigators have developed a mock medical record decision support tool for this project. Each week the investigators will pull a list of patients scheduled for a primary care visit at the Ann Arbor VAMC then calculate each patient's risk based on the clinical guidelines algorithm and compare the statin recommendation against their current prescriptions."
11281625|NCT02820870|BG001|Baseline|Usual Care Group|PACT teams that were not randomized to the intervention will serve as a usual care group and will be expected to follow the VA guidelines and HEDIS measures as part of the VA national roll-out.
11281626|NCT02820870|BG002|Baseline|Total|Total of all reporting groups
11281627|NCT02820870|FG000|Participant Flow|Primary Care Intervention Group|Primary care providers received a personalized decision support tool, an educational program, and an audit and feedback system that evaluated appropriate patients. The intervention lasted 3 months. Providers results for the 3 months prior to the intervention and the 3 months after it ended were also analyzed as controls.
11281628|NCT02820870|FG001|Participant Flow|Usual Care Group|PACT teams that were not randomized to the intervention also received the educational intervention, but otherwise engaged in usual care.
11281629|NCT02820870|OG000|Outcome|Primary Care Intervention Group|"Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines.~Statin Decision Support Intervention: The investigators have developed a mock medical record decision support tool for this project. Each week the investigators will pull a list of patients scheduled for a primary care visit at the Ann Arbor VAMC then calculate each patient's risk based on the clinical guidelines algorithm and compare the statin recommendation against their current prescriptions. For each patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant),"
11281630|NCT02820870|OG001|Outcome|Usual Care Group|PACT teams that were not randomized to the intervention will serve as a usual care group and will be expected to follow the VA guidelines and HEDIS measures as part of the VA national roll-out.
11281631|NCT02820870|OG000|Outcome|Primary Care Intervention Group|"Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines.~Statin Decision Support Intervention: The investigators have developed a mock medical record decision support tool for this project. Each week the investigators will pull a list of patients scheduled for a primary care visit at the Ann Arbor VAMC then calculate each patient's risk based on the clinical guidelines algorithm and compare the statin recommendation against their current prescriptions."
11281632|NCT02820870|OG000|Outcome|Primary Care Intervention Group|"Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines."
11281633|NCT02820870|EG000|Reported Event|Primary Care Intervention Group|"Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines."
11281634|NCT02820870|EG001|Reported Event|Usual Care Group|PACT teams that were not randomized to the intervention will serve as a usual care group and will be expected to follow the VA guidelines and HEDIS measures as part of the VA national roll-out.
11281635|NCT02821104|BG000|Baseline|Healthy Adolescents|Healthy non-Hispanic white adolescents between 12 and 18 years
11281636|NCT02821104|FG000|Participant Flow|Healthy Adolescents|Healthy non-Hispanic white adolescents between 12 and 18 years of age
11281637|NCT02821104|OG000|Outcome|Healthy Adolescents|Non Hispanic white
11281638|NCT02821104|OG000|Outcome|Healthy Adolescents|Healthy non-Hispanic white adolescents between 12 and 18 years
11281639|NCT02821104|OG000|Outcome|Healthy Adolescents|Healthy non Hispanic white adolescents
11281640|NCT02821104|OG000|Outcome|Healthy Adolescents|Healthy non-Hispanic white adolescents between 12 and 18 years of age
11281641|NCT02821104|EG000|Reported Event|Healthy Adolescents|Healthy non-Hispanic white adolescents between 12 and 18 years of age
11281642|NCT02821338|BG000|Baseline|All Participants|"30 participants~Completed subjects received two rounds of Lamictal and Lamotrigine."
11281643|NCT02821338|FG000|Participant Flow|Sequence 1 (Test-Ref-Test-Ref)|"Sequence 1 - ABAB. The study was a single center, randomized, open-label, single dose, 2-treatment, 4-period, 2-sequence, fully replicated, crossover design in healthy male and female subjects. All completed subjects received two rounds of Lamictal and Lamotrigine.~The following investigational products were administered in the fed state:~Treatment A: A single 1-tablet dose of Lamotrigine 200 mg extended-release tablet (Test) Treatment B: A single 1-tablet dose of Lamictal XR 200 mg extended-release tablet (Reference)"
11281644|NCT02821338|FG001|Participant Flow|Sequence 2 (Ref-Test-Ref-Test)|"Sequence 2 - BABA. The study was a single center, randomized, open-label, single dose, 2-treatment, 4-period, 2-sequence, fully replicated, crossover design in healthy male and female subjects. All completed subjects received two rounds of Lamictal and Lamotrigine.~The following investigational products were administered in the fed state:~Treatment A: A single 1-tablet dose of Lamotrigine 200 mg extended-release tablet (Test) Treatment B: A single 1-tablet dose of Lamictal XR 200 mg extended-release tablet (Reference)"
11281645|NCT02821338|OG000|Outcome|Generic Lamotrigine Extended Release Tablet|Lamotrigine Extended Release (generic)
11281646|NCT02821338|OG001|Outcome|Brand Lamictal XR Tablet|Lamictal XR (brand)
11281647|NCT02821338|EG000|Reported Event|Generic Lamotrigine Extended Release Tablet|Lamotrigine Extended Release (generic)
11281648|NCT02821338|EG001|Reported Event|Brand Lamictal XR Tablet|Lamictal XR (brand)
11281649|NCT02821403|BG000|Baseline|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281650|NCT02821403|BG001|Baseline|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281651|NCT02821403|BG002|Baseline|Total|Total of all reporting groups
11281652|NCT02821403|FG000|Participant Flow|Young Adults|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281653|NCT02821403|FG001|Participant Flow|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281654|NCT02821403|OG000|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281655|NCT02821403|OG001|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281656|NCT02821403|OG002|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281657|NCT02821403|OG003|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281658|NCT02821403|OG004|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281659|NCT02821403|OG005|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
11281660|NCT02821403|OG000|Outcome|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281661|NCT02821403|OG001|Outcome|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281662|NCT02821403|EG000|Reported Event|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281663|NCT02821403|EG001|Reported Event|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
11281664|NCT02821416|BG000|Baseline|Benra 30mg q.4 Week|Benralizumab 30mg every 4 Weeks
11281665|NCT02821416|BG001|Baseline|Placebo|Placebo every 4 Weeks
11281666|NCT02821416|BG002|Baseline|Total|Total of all reporting groups
11281667|NCT02821416|FG000|Participant Flow|Benra 30mg q.4 Week|Benralizumab 30mg every 4 Weeks
11281668|NCT02821416|FG001|Participant Flow|Placebo|Placebo every 4 Weeks
11281669|NCT02821416|OG000|Outcome|Benra 30mg q.4 Weeks|Benralizumab 30 mg every 4 Weeks
11281670|NCT02821416|OG001|Outcome|Placebo|Placebo every 4 Weeks
11281671|NCT02821416|OG000|Outcome|Benra 30mg q.4 Weeks|Benralizumab 30mg every 4 weeks
11092380|NCT01539525|FG001|Participant Flow|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11281672|NCT02821416|EG000|Reported Event|Benra 30mg q.4 Week|Benralizumab 30mg every 4 Weeks
11281673|NCT02821416|EG001|Reported Event|Placebo|Placebo every 4 Weeks
11281674|NCT02821455|BG000|Baseline|Lung Surgery With One-Lung Ventilation|"A single cohort of patients undergoing one-lung ventilation during lung surgery~Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery"
11281675|NCT02821455|FG000|Participant Flow|Lung Surgery With One-Lung Ventilation|"A single cohort of patients undergoing one-lung ventilation during lung surgery~Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery"
11281676|NCT02821455|OG000|Outcome|Lung Surgery With One-Lung Ventilation|"A single cohort of patients undergoing one-lung ventilation during lung surgery~Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery"
11281677|NCT02821455|EG000|Reported Event|Lung Surgery With One-Lung Ventilation|"A single cohort of patients undergoing one-lung ventilation during lung surgery~Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery"
11281678|NCT02821715|BG000|Baseline|All Participants|"Participants received either:~A Modafinil 300mg/d/Flecainide placebo, B Modafinil 300mg/d/Flecainide 3mg/d C Modafinil 300mg/d/Flecainide 27mg/d"
11281679|NCT02821715|FG000|Participant Flow|Sequence 1 : ABC|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281680|NCT02821715|FG001|Participant Flow|Sequence 2 : BCA|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281681|NCT02821715|FG002|Participant Flow|Sequence 3: CAB|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281682|NCT02821715|FG003|Participant Flow|Sequence 4: ACB|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281683|NCT02821715|FG004|Participant Flow|Sequence 5: CBA|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281684|NCT02821715|FG005|Participant Flow|Sequence 6: BAC|"Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day~Treatment period A, B and C duration = 2 weeks No wash out between each period"
11281685|NCT02821715|OG000|Outcome|Modafinil + Placebo|"3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks~Active comparator: Modafinil + placebo"
11281686|NCT02821715|OG001|Outcome|THN102 300/3|"3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks~THN102 300/3"
11281687|NCT02821715|OG002|Outcome|THN102 300/27|"3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks~THN102 300/27"
11281688|NCT02821715|EG000|Reported Event|THN102 300/0|"Treatment A : THN102 300/0 Modafinil 300 mg/d Flecainide placebo~Duration : 2 weeks"
11281689|NCT02821715|EG001|Reported Event|THN102 300/3|Treatment B : THN102 300/3 Modafinil 300 mg/d Flecainide 3 mg/d Duration : 2 weeks
11281690|NCT02821715|EG002|Reported Event|THN102 300/27|Treatment C : THN102 300/27 Modafinil 300 mg/d Flecainide 27 mg/d Duration : 2 weeks
11281691|NCT02821819|BG000|Baseline|Random Start Ovarian Stimulation|"Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.~Interventions:~Random start ovarian stimulation~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonists: Cetrorelix 0,25 mg/d~GnRH agonist for triggering: Triptorelin 0,2 mg single dose~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation~GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation."
11281692|NCT02821819|FG000|Participant Flow|Random Start Ovarian Stimulation|"Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.~Interventions:~Random start ovarian stimulation~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonists: Cetrorelix 0,25 mg/d~GnRH agonist for triggering: Triptorelin 0,2 mg single dose~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation~GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation."
11281693|NCT02821819|OG000|Outcome|Random Start Ovarian Stimulation|"Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.~Interventions:~Random start ovarian stimulation~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonists: Cetrorelix 0,25 mg/d~GnRH agonist for triggering: Triptorelin 0,2 mg single dose~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation~GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation."
11281694|NCT02821819|EG000|Reported Event|Random Start Ovarian Stimulation|"Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.~Interventions:~Random start ovarian stimulation~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonists: Cetrorelix 0,25 mg/d~GnRH agonist for triggering: Triptorelin 0,2 mg single dose~Gonadotrophins: Urinary FSH 150-225 IU/d~GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation~GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation."
11281695|NCT02821910|BG000|Baseline|FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)|Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281696|NCT02821910|BG001|Baseline|E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)|Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281697|NCT02821910|BG002|Baseline|FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h
11281698|NCT02821910|BG003|Baseline|E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
11281699|NCT02821910|BG004|Baseline|FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)|Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281700|NCT02821910|BG005|Baseline|E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)|Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281701|NCT02821910|BG006|Baseline|Total|Total of all reporting groups
11281702|NCT02821910|FG000|Participant Flow|FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)|Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281703|NCT02821910|FG001|Participant Flow|E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)|Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281704|NCT02821910|FG002|Participant Flow|FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h
11281705|NCT02821910|FG003|Participant Flow|E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
11281706|NCT02821910|FG004|Participant Flow|FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)|Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281707|NCT02821910|FG005|Participant Flow|E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)|Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281708|NCT02821910|OG000|Outcome|FDC 25 Fed (T1)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281709|NCT02821910|OG001|Outcome|E25+L5+M1000 Fed (R1)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281710|NCT02821910|OG002|Outcome|FDC 25 Fast (T2)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
11281711|NCT02821910|OG003|Outcome|E25+L5+M1000 Fast (R2)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
11281712|NCT02821910|OG004|Outcome|FDC 10 Fed (T3)|Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281713|NCT02821910|OG005|Outcome|E10+L5+M1000 Fed (R3)|Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281714|NCT02821910|EG000|Reported Event|FDC 25 Fed (T1)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281715|NCT02821910|EG001|Reported Event|E25+L5+M1000 Fed (R1)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281716|NCT02821910|EG002|Reported Event|FDC 25 Fast (T2)|Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
11281717|NCT02821910|EG003|Reported Event|E25+L5+M1000 Fast (R2)|Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
11281718|NCT02821910|EG004|Reported Event|FDC 10 Fed (T3)|Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11281719|NCT02821910|EG005|Reported Event|E10+L5+M1000 Fed (R3)|Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
11281720|NCT02821962|BG000|Baseline|Sedentary Prompts (VTAP)|"Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes.~Sedentary prompts from a VTAP device"
11281721|NCT02821962|BG001|Baseline|Usual Care|Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
11281722|NCT02821962|BG002|Baseline|Total|Total of all reporting groups
11281723|NCT02821962|FG000|Participant Flow|Sedentary Prompts (VTAP)|"Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes.~Sedentary prompts from a VTAP device"
11281724|NCT02821962|FG001|Participant Flow|Usual Care|Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
11281725|NCT02821962|OG000|Outcome|Sedentary Prompts (VTAP)|"Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes.~Sedentary prompts from a VTAP device"
11281726|NCT02821962|OG001|Outcome|Usual Care|Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
11281727|NCT02821962|EG000|Reported Event|Sedentary Prompts (VTAP)|"Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes.~Sedentary prompts from a VTAP device"
11281728|NCT02821962|EG001|Reported Event|Usual Care|Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
11281729|NCT02822222|BG000|Baseline|RMJH-111b|Four (4) RMJH-111b (magnesium citrate, tribasic anhydrous) soft gelatin capsules (110 mg elemental magnesium/capsule) orally bid for 7 days
11281730|NCT02822222|BG001|Baseline|Placebo|Four (4) placebo soft gelatin capsules (0 mg elemental magnesium/capsule) orally bid for 7 days
11281731|NCT02822222|BG002|Baseline|Total|Total of all reporting groups
11281732|NCT02822222|FG000|Participant Flow|RMJH-111b|Four (4) RMJH-111b (magnesium citrate, tribasic anhydrous) soft gelatin capsules (110 mg elemental magnesium/capsule) orally bid for 7 days
11281733|NCT02822222|FG001|Participant Flow|Placebo|Four (4) placebo soft gelatin capsules (0 mg elemental magnesium/capsule) orally bid for 7 days
11281734|NCT02822222|OG000|Outcome|RMJH-111b|Four (4) RMJH-111b (magnesium citrate, tribasic anhydrous) soft gelatin capsules (110 mg elemental magnesium/capsule) orally bid for 7 days
11281735|NCT02822222|OG001|Outcome|Placebo|Four (4) placebo soft gelatin capsules (0 mg elemental magnesium/capsule) orally bid for 7 days
11281736|NCT02822222|EG000|Reported Event|RMJH-111b|Four (4) RMJH-111b (magnesium citrate, tribasic anhydrous) soft gelatin capsules (110 mg elemental magnesium/capsule) orally bid for 7 days
11281737|NCT02822222|EG001|Reported Event|Placebo|Four (4) placebo soft gelatin capsules (0 mg elemental magnesium/capsule) orally bid for 7 days
11281738|NCT02822235|BG000|Baseline|Crohn's Disease|Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.
11281739|NCT02822235|BG001|Baseline|Ulcerative Colitis|Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281740|NCT02822235|BG002|Baseline|Total|Total of all reporting groups
11281741|NCT02822235|FG000|Participant Flow|Crohn's Disease|Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.
11281742|NCT02822235|FG001|Participant Flow|Ulcerative Colitis|Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281743|NCT02822235|OG000|Outcome|Crohn's Disease|Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.
11281744|NCT02822235|OG000|Outcome|Ulcerative Colitis|Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281745|NCT02822235|OG000|Outcome|Crohn's Disease (Moderate to Severe Activity)|Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.
11281746|NCT02822235|OG001|Outcome|Ulcerative Colitis (Moderate to Severe Activity)|Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281747|NCT02822235|OG000|Outcome|Crohn's Disease (Moderate to Severe Activity)|Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase.
11281748|NCT02822235|OG001|Outcome|Crohn's Disease (Mild or No Activity)|Participants with diagnosis of mild Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1.
11281749|NCT02822235|OG000|Outcome|Ulcerative Colitis (Moderate to Severe Activity)|Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281750|NCT02822235|OG001|Outcome|Ulcerative Colitis (Mild or No Activity)|Participants with diagnosis of mild ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1.
11281751|NCT02822235|OG001|Outcome|Ulcerative Colitis|Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281752|NCT02822235|EG000|Reported Event|Crohn's Disease|Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.
11281753|NCT02822235|EG001|Reported Event|Ulcerative Colitis|Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.
11281754|NCT02822287|BG000|Baseline|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
11281755|NCT02822287|FG000|Participant Flow|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
11281756|NCT02822287|OG000|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
11281757|NCT02822287|EG000|Reported Event|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
11281758|NCT02822599|BG000|Baseline|RiaSTAP|"Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.~RiaStAP: To decrease post-operative bleeding volume."
11281759|NCT02822599|BG001|Baseline|Saline|"Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.~Saline: Placebo consisting of normal saline 0.9%"
11281760|NCT02822599|BG002|Baseline|Total|Total of all reporting groups
11281761|NCT02822599|FG000|Participant Flow|RiaSTAP|"Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.~RiaStAP: To decrease post-operative bleeding volume."
11281762|NCT02822599|FG001|Participant Flow|Saline|"Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.~Saline: Placebo consisting of normal saline 0.9%"
11281763|NCT02822599|OG000|Outcome|RiaSTAP|"Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.~RiaStAP: To decrease post-operative bleeding volume."
11281764|NCT02822599|OG001|Outcome|Saline|"Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.~Saline: Placebo consisting of normal saline 0.9%"
11281765|NCT02822599|EG000|Reported Event|RiaStap|RiaStap_Treatment received an infusion of RiaSTAP, right after the termination of CPB at a dose of 70 mg/kg.
11281766|NCT02822599|EG001|Reported Event|Placebo|Placebo_Treatment received a placebo of Normal Saline 0.9% (NS) during the same time period. The volume of NS was calculated to be the same volume that would be used IF the patient were receiving RiaSTAP.
11281767|NCT02822612|BG000|Baseline|Retinal Disease|Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).
11281768|NCT02822612|BG001|Baseline|Glaucoma|Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).
11281769|NCT02822612|BG002|Baseline|Strabismus|Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).
11281770|NCT02822612|BG003|Baseline|Ocular Comorbidities|Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.
11281771|NCT02822612|BG004|Baseline|Healthy Volunteers|Fifteen healthy volunteers with no self-reported history of ocular disease.
11281772|NCT02822612|BG005|Baseline|Total|Total of all reporting groups
11281773|NCT02822612|FG000|Participant Flow|Retinal Disease|Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).
11281774|NCT02822612|FG001|Participant Flow|Glaucoma|Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).
11281775|NCT02822612|FG002|Participant Flow|Strabismus|Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).
11281776|NCT02822612|FG003|Participant Flow|Ocular Comorbidities|Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.
11281777|NCT02822612|FG004|Participant Flow|Healthy Volunteers|Fifteen healthy volunteers with no self-reported history of ocular disease.
11281778|NCT02822612|OG000|Outcome|Retinal Disease|Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).
11281779|NCT02822612|OG001|Outcome|Glaucoma|Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).
11281780|NCT02822612|OG002|Outcome|Strabismus|Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).
11281781|NCT02822612|OG003|Outcome|Ocular Comorbidities|Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.
11281782|NCT02822612|OG004|Outcome|Healthy Volunteers|Fifteen healthy volunteers with no self-reported history of ocular disease.
11281783|NCT02822612|EG000|Reported Event|Retinal Disease|Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).
11281784|NCT02822612|EG001|Reported Event|Glaucoma|Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).
11281785|NCT02822612|EG002|Reported Event|Strabismus|Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).
11281786|NCT02822612|EG003|Reported Event|Ocular Comorbidities|Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.
11281787|NCT02822612|EG004|Reported Event|Healthy Volunteers|Fifteen healthy volunteers with no self-reported history of ocular disease.
11281788|NCT02822794|BG000|Baseline|SOF/VEL+RBV 12 Weeks (GT1)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
11281789|NCT02822794|BG001|Baseline|SOF/VEL+RBV 12 Weeks (GT2)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
11281790|NCT02822794|BG002|Baseline|SOF/VEL+RBV 24 Weeks (GT1)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
11281791|NCT02822794|BG003|Baseline|SOF/VEL+RBV 24 Weeks (GT2)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
11281792|NCT02822794|BG004|Baseline|Total|Total of all reporting groups
11281793|NCT02822794|FG000|Participant Flow|SOF/VEL FDC + RBV 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily + ribavirin (RBV) capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks
11281794|NCT02822794|FG001|Participant Flow|SOF/VEL FDC + RBV 24 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks
11281795|NCT02822794|OG000|Outcome|SOF/VEL+RBV 12 Weeks (GT1)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
11281796|NCT02822794|OG001|Outcome|SOF/VEL+RBV 12 Weeks (GT2)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
11281797|NCT02822794|OG002|Outcome|SOF/VEL+RBV 24 Weeks (GT1)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
11281798|NCT02822794|OG003|Outcome|SOF/VEL+RBV 24 Weeks (GT2)|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
11281799|NCT02822794|OG000|Outcome|SOF/VEL+RBV 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or 2 HCV infection
11281800|NCT02822794|OG001|Outcome|SOF/VEL+RBV 24 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or 2 HCV infection
11281801|NCT02822794|OG000|Outcome|SOF/VEL+RBV 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection
11281802|NCT02822794|OG001|Outcome|SOF/VEL+RBV 24 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection
11281803|NCT02822794|OG000|Outcome|SOF/VEL+RBV 24 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection
11281804|NCT02822794|EG000|Reported Event|SOF/VEL+RBV 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection
11281805|NCT02822794|EG001|Reported Event|SOF/VEL+RBV 24 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection
11281806|NCT02822885|BG000|Baseline|Ultrasonography|"Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries~Ultrasonography: Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries"
11281807|NCT02822885|FG000|Participant Flow|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
11281808|NCT02822885|OG000|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
11281809|NCT02822885|EG000|Reported Event|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
11281810|NCT02822950|BG000|Baseline|Ceftazadime/Avibactam|"Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.~Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients"
11281811|NCT02822950|FG000|Participant Flow|Ceftazadime/Avibactam|"Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.~Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients"
11281812|NCT02822950|OG000|Outcome|Ceftazadime/Avibactam|"Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.~Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients"
11281813|NCT02822950|EG000|Reported Event|Ceftazadime/Avibactam|"Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.~Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients"
11281814|NCT02823080|BG000|Baseline|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281815|NCT02823080|BG001|Baseline|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11092381|NCT01539525|FG002|Participant Flow|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
11281816|NCT02823080|BG002|Baseline|Total|Total of all reporting groups
11281817|NCT02823080|FG000|Participant Flow|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281818|NCT02823080|FG001|Participant Flow|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281819|NCT02823080|OG000|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281820|NCT02823080|OG001|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281821|NCT02823080|OG000|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281822|NCT02823080|EG000|Reported Event|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281823|NCT02823080|EG001|Reported Event|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
11281824|NCT02823431|BG000|Baseline|Analgesia Arm|"Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).~lidocaine gel"
11281825|NCT02823431|BG001|Baseline|Placebo Arm|"Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed.~Plain aqueous gel"
11281826|NCT02823431|BG002|Baseline|Total|Total of all reporting groups
11281827|NCT02823431|FG000|Participant Flow|Analgesia Arm|"Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).~lidocaine gel"
11281828|NCT02823431|FG001|Participant Flow|Placebo Arm|"Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed.~Plain aqueous gel"
11281829|NCT02823431|OG000|Outcome|Analgesia Arm|"Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).~lidocaine gel"
11281830|NCT02823431|OG001|Outcome|Placebo Arm|"Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed.~Plain aqueous gel"
11281831|NCT02823431|EG000|Reported Event|Analgesia Arm|"Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).~lidocaine gel"
11281832|NCT02823431|EG001|Reported Event|Placebo Arm|"Participants randomized to this arm will first undergo uroflow studies then be given a 2-hour rest. Urodynamic testing without analgesia (standard of care) will then be performed.~Plain aqueous gel"
11281833|NCT02823470|BG000|Baseline|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through a de-activated smart pill bottle (control).
11281834|NCT02823470|BG001|Baseline|LUM/IVA Through Activated Smart Pill Bottle (Test)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through an activated smart pill bottle.
11281835|NCT02823470|BG002|Baseline|Total|Total of all reporting groups
11281836|NCT02823470|FG000|Participant Flow|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received lumacaftor (LUM) 400 milligram (mg) in combination with ivacaftor (IVA) 250 mg as oral tablet every 12 hours (q12h) for up to 35 weeks through a de-activated smart pill bottle (control).
11281837|NCT02823470|FG001|Participant Flow|LUM/IVA Through Activated Smart Pill Bottle (Test)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through an activated smart pill bottle.
11281838|NCT02823470|OG000|Outcome|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through a de-activated smart pill bottle (control).
11281839|NCT02823470|OG001|Outcome|LUM/IVA Through Activated Smart Pill Bottle (Test)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through an activated smart pill bottle.
11281840|NCT02823470|OG000|Outcome|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received lumacaftor (LUM) 400 milligram (mg) in combination with ivacaftor (IVA) 250 mg as oral tablet every 12 hours (q12h) for up to 35 weeks through a de-activated smart pill bottle.
11281841|NCT02823470|OG001|Outcome|LUM/IVA Through Activated Smart Pill Bottle (Test)|Participants received lumacaftor (LUM) 400 milligram (mg) in combination with ivacaftor (IVA) 250 mg as oral tablet every 12 hours (q12h) for up to 35 weeks through an activated smart pill bottle.
11281842|NCT02823470|OG000|Outcome|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through a de-activated smart pill bottle.
11281843|NCT02823470|EG000|Reported Event|LUM/IVA Through Deactivated Smart Pill Bottle (Control)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through a de-activated smart pill bottle (control).
11281844|NCT02823470|EG001|Reported Event|LUM/IVA Through Activated Smart Pill Bottle (Test)|Participants received LUM 400 mg in combination with IVA 250 mg as oral tablet q12h for up to 35 weeks through an activated smart pill bottle.
11281845|NCT02823600|BG000|Baseline|RetinaVue 100 Camera|All participants will have a retinal eye exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
11281846|NCT02823600|FG000|Participant Flow|RetinaVue 100 Camera|"Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera~RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit."
11281847|NCT02823600|OG000|Outcome|Images|This group is the total number of images, 136, captured from the study population.
11281848|NCT02823600|OG000|Outcome|RetinaVue 100 Camera|All participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
11281849|NCT02823600|OG000|Outcome|RetinaVue 100 Camera|"Participants will have a retinal exam completed by study staff using the FDA-approved RetinaVue 100 hand-held camera~RetinaVue 100 camera: Images of the subject's retina will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit."
11281850|NCT02823600|EG000|Reported Event|ESRD|This study only had only one arm. All those individuals who met eligibility criteria and provided voluntary consent, were enrolled to this study and followed the same procedures.
11281851|NCT02823964|BG000|Baseline|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11281852|NCT02823964|FG000|Participant Flow|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11281853|NCT02823964|OG000|Outcome|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11281854|NCT02823964|EG000|Reported Event|Liprotamase|"Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement~Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement"
11281855|NCT02824224|BG000|Baseline|Tamoxifen|"Tamoxifen 10mg tablet by mouth twice daily for 7 days~Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course"
11281856|NCT02824224|BG001|Baseline|Placebo|"Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days~Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet"
11281857|NCT02824224|BG002|Baseline|Total|Total of all reporting groups
11281858|NCT02824224|FG000|Participant Flow|Tamoxifen|"Tamoxifen 10mg tablet by mouth twice daily for 7 days~Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course"
11281859|NCT02824224|FG001|Participant Flow|Placebo|"Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days~Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet"
11281860|NCT02824224|OG000|Outcome|Tamoxifen|"Tamoxifen 10mg tablet by mouth twice daily for 7 days~Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course"
11281861|NCT02824224|OG001|Outcome|Placebo|"Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days~Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet"
11281862|NCT02824224|EG000|Reported Event|Tamoxifen|"Tamoxifen 10mg tablet by mouth twice daily for 7 days~Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course"
11281863|NCT02824224|EG001|Reported Event|Placebo|"Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days~Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet"
11281864|NCT02824432|BG000|Baseline|TAK-085 2 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
11281865|NCT02824432|BG001|Baseline|TAK-085 4 g|A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
11281866|NCT02824432|BG002|Baseline|Total|Total of all reporting groups
11281867|NCT02824432|FG000|Participant Flow|TAK-085 2 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
11281868|NCT02824432|FG001|Participant Flow|TAK-085 4 g|A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
11281869|NCT02824432|OG000|Outcome|TAK-085 2 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
11281870|NCT02824432|OG001|Outcome|TAK-085 4 g|A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
11281871|NCT02824432|EG000|Reported Event|TAK-085 2 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
11281872|NCT02824432|EG001|Reported Event|TAK-085 4 g|A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
11281873|NCT02824562|BG000|Baseline|Intervention|The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.
11281874|NCT02824562|BG001|Baseline|Control|"The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group."
11281875|NCT02824562|BG002|Baseline|Total|Total of all reporting groups
11281876|NCT02824562|FG000|Participant Flow|Intervention|"The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.~Behavioral intervention for chronic pain in HIV"
11281877|NCT02824562|FG001|Participant Flow|Control|"The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group."
11281878|NCT02824562|OG000|Outcome|Intervention|"The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.~Behavioral intervention for chronic pain in HIV"
11281879|NCT02824562|OG001|Outcome|Control|"The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group."
11281880|NCT02824562|EG000|Reported Event|Intervention|The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.
11281881|NCT02824562|EG001|Reported Event|Control|"The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group."
11281882|NCT02824913|BG000|Baseline|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution~At Visit 3 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
11281883|NCT02824913|BG001|Baseline|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~At Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution"
11281884|NCT02824913|BG002|Baseline|Total|Total of all reporting groups
11281885|NCT02824913|FG000|Participant Flow|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 Placebo Comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
11337689|NCT03591146|FG001|Participant Flow|TLC590 380mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11281886|NCT02824913|FG001|Participant Flow|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo treatment will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II"
11281887|NCT02824913|OG000|Outcome|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution~At Visit 3 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
10970532|NCT00910871|EG000|Reported Event|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
11281888|NCT02824913|OG001|Outcome|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~At Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II P-321 Ophthalmic Solution"
11281889|NCT02824913|OG000|Outcome|P-321 Ophthalmic Solution Then Placebo Comparator|"At Visit 2 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 Placebo Comparator will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II"
11281890|NCT02824913|OG001|Outcome|Placebo Comparator Then P-321 Ophthalmic Solution|"At Visit 2 Placebo treatment will be administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~After a washout period of 7-14 days at Visit 3 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II"
11281891|NCT02824913|EG000|Reported Event|P-321 Ophthalmic Solution|"0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II~P-321 Ophthalmic Solution"
11281892|NCT02824913|EG001|Reported Event|Drug: P-321 Ophthalmic Solution Placebo|"Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II~P-321 Ophthalmic Solution placebo"
11281893|NCT02825212|BG000|Baseline|Pts With Hep C Virus Infection-Related Cryoglobulinemia|"Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.~Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .~Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects."
11281894|NCT02825212|FG000|Participant Flow|Pts With Hep C Virus Infection-Related Cryoglobulinemia|"Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.~Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .~Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects."
11281895|NCT02825212|OG000|Outcome|Pts With Hep C Virus Infection-Related Cryoglobulinemia|"Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.~Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .~Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects."
11281896|NCT02825212|EG000|Reported Event|Pts With Hep C Virus Infection-Related Cryoglobulinemia|"Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.~Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .~Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects."
11337690|NCT03591146|FG002|Participant Flow|TLC590 570mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11092382|NCT01539525|OG000|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11092383|NCT01539525|OG001|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11281897|NCT02825251|BG000|Baseline|Faster Aspart|The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281898|NCT02825251|BG001|Baseline|NovoRapid|The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281899|NCT02825251|BG002|Baseline|Total|Total of all reporting groups
11281900|NCT02825251|FG000|Participant Flow|Faster Aspart|The subjects received faster aspart (basal-bolus regimen) by continuous subcutaneous insulin infusion (CSII) for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that blood glucose (BG) was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281901|NCT02825251|FG001|Participant Flow|NovoRapid|The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281902|NCT02825251|OG000|Outcome|Faster Aspart|The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281903|NCT02825251|OG001|Outcome|NovoRapid|The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281904|NCT02825251|EG000|Reported Event|Faster Aspart|The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281905|NCT02825251|EG001|Reported Event|NovoRapid|The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L [71-108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
11281906|NCT02825420|BG000|Baseline|Prior Use of Antiangiogenics|"Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281907|NCT02825420|BG001|Baseline|No Prior Use of Antiangiogenics|"Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281908|NCT02825420|BG002|Baseline|Total|Total of all reporting groups
11281909|NCT02825420|FG000|Participant Flow|Prior Use of Antiangiogenics|"Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281910|NCT02825420|FG001|Participant Flow|No Prior Use of Antiangiogenics|"Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281911|NCT02825420|OG000|Outcome|Full Analysis Set|The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
11281912|NCT02825420|OG000|Outcome|Prior Use of Antiangiogenics|"Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281913|NCT02825420|OG001|Outcome|No Prior Use of Antiangiogenics|"Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281914|NCT02825420|OG000|Outcome|Positive BRCA|Patients with Positive BRCA
11281915|NCT02825420|OG001|Outcome|Negative|Patients with Negative BRCA
11281916|NCT02825420|OG000|Outcome|Fully Platinum Sensitivity|Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
11281917|NCT02825420|OG001|Outcome|Partially Platinum Sensitivity|Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
11281918|NCT02825420|EG000|Reported Event|Prior Use of Antiangiogenics|"Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281919|NCT02825420|EG001|Reported Event|No Prior Use of Antiangiogenics|"Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib"
11281920|NCT02825550|BG000|Baseline|Hepatoma Treated Using Taiwan ACE Beads|Clinical information of T-ACE beads H-series: Gender Male/Female 7/5, Age 71±8. The initial number of participants in the study was 13. However, one patient's blood test did not meet the standard before the operation, which led to his/her withdrawal from the clinical trial. Consequently, the total number of participants analyzed was 12.
11281921|NCT02825550|FG000|Participant Flow|Hepatoma Patients Treated With T-ACE Beads|In the Hepatoma Embolization Therapy, the catheter was placed to the appropriate position in tumor-supplying artery. Lipiodol containing doxorubicin were firstly injected, followed by the injection of our T-ACE beads-H series microspheres. The follow-up blood tests and adverse events were conducted afterwards. CT scan or MRI would be scheduled at the first and the third months to evaluate the change of tumor size.
11281922|NCT02825550|OG000|Outcome|Hepatoma Treated Using Taiwan ACE Beads|"Hepatoma patients received Taiwan ACE Beads (T-ACE) microspheres embolization to treat the tumors.~Taiwan ACE Beads: The procedure is similar with conventional TACE. Radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.~Survival rate was evaluated since beginning of treatment until date of death or final observation."
11281923|NCT02825550|OG000|Outcome|Hepatoma Patients Treated With T-ACE Beads|We have 7 male and 5 female patients eligible in this study, HBV 4+1, HCV5+1, non-HBV and non-HCV 2, mean age 71± 8. Two patient received treatment at the first time. The other 10 patients received RFA 13 times, and TACE 23 times, and surgery 2 times. The response of the target lesions are: CR 3 PR 4 SD 3 PD 2 (for target lesions), and CR 2 PR 3 SD 3 PD 4 (for the overall response). Liver function, serological ALT(35±24) had mild elevation on the second day (61±47), but all return to baseline (40±20). AFP decreased from 168± 382 to 156± 264. [Conclusion] Our T-ACE Beads are safe and has some effects in treating hepatoma patients.For further clinical trials, loading appropriate chemotherapeutic agents to our microspheres for TACE is needed.
11281924|NCT02825550|OG000|Outcome|Hepatoma Treated Using Taiwan ACE Beads|"Hepatoma patients received Taiwan ACE Beads (T-ACE) microspheres embolization to treat the tumors.~Taiwan ACE Beads: The procedure is similar with conventional TACE. Radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol."
11281925|NCT02825550|EG000|Reported Event|Adverse Event|There was no adverse event reported in this trial.
11281926|NCT02825680|BG000|Baseline|Enhanced NCP Support|"Teams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from the National Center for Health Promotion and Disease Prevention (NCP).~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls, online tools and resources, and technical assistance. Facilities will also have access to a customized cube of administrative data including sessions delivered, weight outcomes, and levels of participation for all Veterans Health Administration (VHA) MOVE! programs."
11281927|NCT02825680|BG001|Baseline|LEAP Intervention|"Cohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls, online tools and resources, and technical assistance. Facilities will also have access to a customized cube of administrative data including sessions delivered, weight outcomes, and levels of participation for all VHA MOVE! programs.~LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the Institute for Healthcare Improvement (IHI) Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool."
11281928|NCT02825680|BG002|Baseline|Total|Total of all reporting groups
11281929|NCT02825680|FG000|Participant Flow|Enhanced NCP Support|"Teams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from the National Center for Health Promotion and Disease Prevention (NCP).~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool"
11281930|NCT02825680|FG001|Participant Flow|LEAP Intervention|"Cohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool~LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the Institute for Healthcare Improvement (IHI) Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool."
11281931|NCT02825680|OG000|Outcome|Enhanced NCP Support|"Teams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from NCP.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool"
11281932|NCT02825680|OG001|Outcome|LEAP Intervention|"Cohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool~LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model of Change, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool"
11281933|NCT02825680|EG000|Reported Event|Enhanced NCP Support|"Teams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from NCP.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool"
11281934|NCT02825680|EG001|Reported Event|LEAP Intervention|"Cohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.~Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool~LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model of Change, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool"
11281935|NCT02825849|BG000|Baseline|PRP Intrauterine Infusion|"Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles~Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP."
11281936|NCT02825849|BG001|Baseline|Control Group With Standard Treatment Only|Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
11281937|NCT02825849|BG002|Baseline|Total|Total of all reporting groups
11281938|NCT02825849|FG000|Participant Flow|PRP Intrauterine Infusion|"Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles~Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP."
11281939|NCT02825849|FG001|Participant Flow|Control Group With Standard Treatment Only|Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
11281940|NCT02825849|OG000|Outcome|PRP Intrauterine Infusion|"Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles~Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP."
11281941|NCT02825849|OG001|Outcome|Control Group With Standard Treatment Only|Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
11281942|NCT02825849|EG000|Reported Event|PRP Intrauterine Infusion|"Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles~Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP."
11281943|NCT02825849|EG001|Reported Event|Control Group With Standard Treatment Only|Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
11281944|NCT02825966|BG000|Baseline|AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device|Assigned to wear the AUDICOR device first, then the WCD, and finally the AUDICOR device again.
11281945|NCT02825966|FG000|Participant Flow|AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device|First assigned to wear the AUDICOR device for 15 minutes. Then, assigned to wear the WCD during activities of daily living, including at least 6 hours of overnight wear. Total anticipated wear time with WCD is 12-16 hours. Finally, assigned to wear AUDICOR device for 15 minutes after finishing the WCD wear.
11281946|NCT02825966|OG000|Outcome|AUDICOR AM Device (First) Wear|First, assigned to wear AUDICOR device for 15 minutes.
11281947|NCT02825966|OG001|Outcome|LifeVest Wear|Subjects removed the AUDICOR device and wore the LifeVest device for 12-16 hours
11281948|NCT02825966|OG002|Outcome|AUDICOR AM Device (Second) Wear|Subjects removed the LifeVest and then wore the AUDICOR AM device for 15 minutes
11281949|NCT02825966|EG000|Reported Event|AUDICOR AM Device|All study subjects during the time the AUDICOR AM device was used.
11281950|NCT02825966|EG001|Reported Event|LifeVest|All study subjects during the time the LifeVest device was used.
11281951|NCT02825992|BG000|Baseline|AcQMap System|"Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation~AcQMap System: 3D imaging and mapping system for cardiac chambers"
11281952|NCT02825992|FG000|Participant Flow|AcQMap System|"Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation~AcQMap System: 3D imaging and mapping system for cardiac chambers"
11281953|NCT02825992|OG000|Outcome|AcQMap System|"Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation~AcQMap System: 3D imaging and mapping system for cardiac chambers"
11281954|NCT02825992|OG000|Outcome|6 Month Off AADs|Freedom from AF at 6 Months post ablation off Anti-Arrhythmic Drug (AADs)
11281955|NCT02825992|OG001|Outcome|6 Month on AADs|Freedom from AF at 6 Months post ablation on Anti-Arrhythmic Drug (AADs)
11281956|NCT02825992|OG002|Outcome|9 Months Off AADs|Freedom from AF at 9 Months post ablation off Anti-Arrhythmic Drug (AADs)
11281957|NCT02825992|OG003|Outcome|9 Months on AADs|Freedom from AF at 9 Months post ablation on Anti-Arrhythmic Drug (AADs)
11281958|NCT02825992|OG004|Outcome|12 Months Off AADs|Freedom from AF at 12 Months post ablation off Anti-Arrhythmic Drug (AADs)
11281959|NCT02825992|OG005|Outcome|12 Months on AADs|Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs)
11281960|NCT02825992|EG000|Reported Event|AcQMap System|"Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation~AcQMap System: 3D imaging and mapping system for cardiac chambers"
11281961|NCT02826421|BG000|Baseline|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281962|NCT02826421|BG001|Baseline|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281963|NCT02826421|BG002|Baseline|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281964|NCT02826421|BG003|Baseline|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
11281965|NCT02826421|BG004|Baseline|Total|Total of all reporting groups
11281966|NCT02826421|FG000|Participant Flow|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281967|NCT02826421|FG001|Participant Flow|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281968|NCT02826421|FG002|Participant Flow|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281969|NCT02826421|FG003|Participant Flow|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
11281970|NCT02826421|OG000|Outcome|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281971|NCT02826421|OG001|Outcome|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281972|NCT02826421|OG002|Outcome|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
11281973|NCT02826421|OG001|Outcome|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
11281974|NCT02826421|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11281975|NCT02826421|EG001|Reported Event|UltraSert|All subjects treated with UltraSert
11281976|NCT02826421|EG002|Reported Event|iTec|All subjects treated with iTec
11281977|NCT02826421|EG003|Reported Event|iSert|All subjects treated with iSert
11281978|NCT02826421|EG004|Reported Event|Monarch III D|All subjects treated with Monarch III D
11281979|NCT02826603|BG000|Baseline|Secukinumab 300mg (2 x 150 mg)|Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)
11281980|NCT02826603|BG001|Baseline|Ustekinumab 2 x 45mg or 90mg|Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)
11281981|NCT02826603|BG002|Baseline|Total|Total of all reporting groups
11281982|NCT02826603|FG000|Participant Flow|Secukinumab 300mg (2 x 150 mg)|Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)
11281983|NCT02826603|FG001|Participant Flow|Ustekinumab 2 x 45mg or 90mg|Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)
11281984|NCT02826603|OG000|Outcome|Secukinumab 300mg (2 x 150 mg)|Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)
11281985|NCT02826603|OG001|Outcome|Ustekinumab 2 x 45mg or 90mg|Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)
11281986|NCT02826603|EG000|Reported Event|AIN457 300 mg|Secukinumab 300mg s.c. injection in 2 150mg pre-fiilled syringes
11281987|NCT02826603|EG001|Reported Event|UST 45/90 mg|Ustekinumab s.c. 45mg or 90 mg (depending on body weight) (using 45mg pre-filled syringes)
11281988|NCT02826603|EG002|Reported Event|All Patients|All Patients from both arms
11281989|NCT02826694|BG000|Baseline|Well Infant, Whole Exome Sequencing|Healthy infants and their parents enrolled in the study prenatally will participate. After the infant is born saliva sample will be collected for DNA extraction and whole exome sequencing will be done. Investigators will analyze genes that are associated with conditions that have childhood onset and are medically actionable.
11281990|NCT02826694|BG001|Baseline|Diagnosed, Whole Exome Sequencing|Infants and children with diagnosed conditions whose parents enroll in the study and consent to having their child sequenced will have saliva samples obtained and whole exome sequencing will be done on extracted DNA. In addition to returning results of conditions associated with the child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable.
11281991|NCT02826694|BG002|Baseline|Total|Total of all reporting groups
11281992|NCT02826694|FG000|Participant Flow|Well Infant, Whole Exome Sequencing|Healthy infants and their parents enrolled in the study prenatally will participate. After the infant is born saliva sample will be collected for DNA extraction and whole exome sequencing will be done. Investigators will analyze results associated with childhood onset, medically actionable conditions.
11281993|NCT02826694|FG001|Participant Flow|Diagnosed, Whole Exome Sequencing|Infants and children with diagnosed conditions whose parents enroll in the study and consent to having their child sequenced will have saliva samples obtained and whole exome sequencing will be done on extracted DNA. In addition to returning results of conditions associated with the child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable.
11281994|NCT02826694|OG000|Outcome|Well Infant, Whole Exome Sequencing|Healthy infants and their parents enrolled in the study prenatally will participate. After the infant is born saliva sample will be collected for DNA extraction and whole exome sequencing will be done.
11281995|NCT02826694|OG001|Outcome|Diagnosed, Whole Exome Sequencing|"Infants and children with diagnosed conditions whose parents enroll in the study and consent to having their child sequenced will have saliva samples obtained and whole exome sequencing will be done on extracted DNA.~In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable."
11281996|NCT02826694|OG000|Outcome|Decision Arm|"2/3 of families from both groups of the study (Well Infant and Diagnosed) were randomized into the Decision Arm that could learn additional information from results of their child's genome sequencing (childhood onset non-medically actionable conditions, adult onset actionable conditions, or carrier status). Families include single mothers or couples. Numbers indicate total number who completed the time 3 and time 4 distress measure."
11281997|NCT02826694|OG001|Outcome|Control Arm|"1/3 of families from both groups of the study (Well Infant and Diagnosed) were randomized into the Control Arm and did not receive the option of additional information from their child's genome sequencing. Families include single mothers or couples. Numbers indicate total number who completed the time 3 and time 4 distress measure."
11281998|NCT02826694|EG000|Reported Event|Well Infant, Whole Exome Sequencing|"Healthy infants and their parents enrolled in the study prenatally will participate. After the infant is born saliva sample will be collected for DNA extraction and whole exome sequencing will be done.~Well infant, whole exome sequencing: Whole exome sequencing will be performed in children with diagnosed conditions. Investigators will analyze results that are associated with their condition."
11281999|NCT02826694|EG001|Reported Event|Diagnosed, Whole Exome Sequencing|"Infants and children with diagnosed conditions whose parents enroll in the study and consent to having their child sequenced will have saliva samples obtained and whole exome sequencing will be done on extracted DNA.~Diagnosed, whole exome sequencing: In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable."
11282000|NCT02826798|BG000|Baseline|VBI-1501A: 0.5µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282001|NCT02826798|BG001|Baseline|VBI-1501A: 1.0µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282002|NCT02826798|BG002|Baseline|VBI-1501A: 2.0 µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282003|NCT02826798|BG003|Baseline|VBI-1501: 1.0µg Without Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282004|NCT02826798|BG004|Baseline|Placebo|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282005|NCT02826798|BG005|Baseline|Total|Total of all reporting groups
11282006|NCT02826798|FG000|Participant Flow|VBI-1501A: 0.5µg With Adjuvant|Healthy cytomegalovirus (CMV)-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282007|NCT02826798|FG001|Participant Flow|VBI-1501A: 1.0µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282008|NCT02826798|FG002|Participant Flow|VBI-1501A: 2.0 µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282009|NCT02826798|FG003|Participant Flow|VBI-1501: 1.0µg Without Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282010|NCT02826798|FG004|Participant Flow|Placebo|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282011|NCT02826798|OG000|Outcome|VBI-1501A: 0.5µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282012|NCT02826798|OG001|Outcome|VBI-1501A: 1.0µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282013|NCT02826798|OG002|Outcome|VBI-1501A: 2.0 µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282014|NCT02826798|OG003|Outcome|VBI-1501: 1.0µg Without Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282015|NCT02826798|OG004|Outcome|Placebo|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282016|NCT02826798|EG000|Reported Event|VBI-1501A: 0.5µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282017|NCT02826798|EG001|Reported Event|VBI-1501A: 1.0µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282018|NCT02826798|EG002|Reported Event|VBI-1501A: 2.0 µg With Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282019|NCT02826798|EG003|Reported Event|VBI-1501: 1.0µg Without Adjuvant|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
10970533|NCT00910910|BG000|Baseline|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
10970534|NCT00910910|BG001|Baseline|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
11282020|NCT02826798|EG004|Reported Event|Placebo|Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
11282021|NCT02827500|BG000|Baseline|Usual Care|"Placebo Comparator: usual care~Usual Care: Placebo Comparator: usual care"
11282022|NCT02827500|BG001|Baseline|Pre-discharge Ivabradine|"Active Comparator: ivabradine~ivabradine: Active Comparator: ivabradine"
11282023|NCT02827500|BG002|Baseline|Total|Total of all reporting groups
11282024|NCT02827500|FG000|Participant Flow|Usual Care|"Placebo Comparator: usual care~Usual Care: Placebo Comparator: usual care"
11282025|NCT02827500|FG001|Participant Flow|Pre-discharge Ivabradine|"Active Comparator: ivabradine~ivabradine: Active Comparator: ivabradine"
11282026|NCT02827500|OG000|Outcome|Usual Care|"Placebo Comparator: usual care~Usual Care: Placebo Comparator: usual care"
11282027|NCT02827500|OG001|Outcome|Pre-discharge Ivabradine|"Active Comparator: ivabradine~ivabradine: Active Comparator: ivabradine"
11282028|NCT02827500|EG000|Reported Event|Usual Care|"Placebo Comparator: usual care~Usual Care: Placebo Comparator: usual care"
11282029|NCT02827500|EG001|Reported Event|Pre-discharge Ivabradine|"Active Comparator: ivabradine~ivabradine: Active Comparator: ivabradine"
11282030|NCT02827708|BG000|Baseline|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11282031|NCT02827708|BG001|Baseline|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
11282032|NCT02827708|BG002|Baseline|Total|Total of all reporting groups
10970535|NCT00910910|BG002|Baseline|Total|Total of all reporting groups
11092384|NCT01539525|OG002|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
11092385|NCT01539525|OG000|Outcome|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11282033|NCT02827708|FG000|Participant Flow|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11282034|NCT02827708|FG001|Participant Flow|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
11282035|NCT02827708|OG000|Outcome|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11282036|NCT02827708|OG001|Outcome|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
11282037|NCT02827708|EG000|Reported Event|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11282038|NCT02827708|EG001|Reported Event|Placebo|Participants were to take oral semaglutide placebo tablets once daily from week 0 to week 26.
11282039|NCT02828020|BG000|Baseline|Placebo|2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282040|NCT02828020|BG001|Baseline|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
10970536|NCT00910910|FG000|Participant Flow|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
11092386|NCT01539525|OG001|Outcome|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11282041|NCT02828020|BG002|Baseline|Ubrogepant 100 mg|2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282042|NCT02828020|BG003|Baseline|Total|Total of all reporting groups
11282043|NCT02828020|FG000|Participant Flow|Placebo|2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282044|NCT02828020|FG001|Participant Flow|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282045|NCT02828020|FG002|Participant Flow|Ubrogepant 100 mg|2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282046|NCT02828020|OG000|Outcome|Placebo|2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282047|NCT02828020|OG001|Outcome|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282048|NCT02828020|OG002|Outcome|Ubrogepant 100 mg|2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282049|NCT02828020|EG000|Reported Event|Placebo|2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282050|NCT02828020|EG001|Reported Event|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282051|NCT02828020|EG002|Reported Event|Ubrogepant 100 mg|2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
11282052|NCT02828111|BG000|Baseline|Patidegib Gel 2% - Once Daily|Applied topically once daily for 12 weeks (Cohort 1)
11282053|NCT02828111|BG001|Baseline|Patidegib Gel 4% - Once Daily|Applied topically once daily for 12 weeks (Cohort 2)
11282054|NCT02828111|BG002|Baseline|Patidegib Gel 2% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 3)
11282055|NCT02828111|BG003|Baseline|Patidegib Gel 4% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 4)
11282056|NCT02828111|BG004|Baseline|Vehicle Gel|Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
11282057|NCT02828111|BG005|Baseline|Total|Total of all reporting groups
11282058|NCT02828111|FG000|Participant Flow|Patidegib Gel 2% - Once Daily|Applied topically once daily for 12 weeks (Cohort 1)
10970537|NCT00910910|FG001|Participant Flow|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
11282059|NCT02828111|FG001|Participant Flow|Patidegib Gel 4% - Once Daily|Applied topically once daily for 12 weeks (Cohort 2)
11282060|NCT02828111|FG002|Participant Flow|Patidegib Gel 2% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 3)
11282061|NCT02828111|FG003|Participant Flow|Patidegib Gel 4% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 4)
11282062|NCT02828111|FG004|Participant Flow|Vehicle Gel|Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
11282063|NCT02828111|OG000|Outcome|Patidegib Gel 2% - Once Daily|Applied topically once daily for 12 weeks (Cohort 1)
11282064|NCT02828111|OG001|Outcome|Patidegib Gel 4% - Once Daily|Applied topically once daily for 12 weeks (Cohort 2)
11282065|NCT02828111|OG002|Outcome|Patidegib Gel 2% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 3)
11282066|NCT02828111|OG003|Outcome|Patidegib Gel 4% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 4)
11282067|NCT02828111|OG004|Outcome|Vehicle Gel|Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
11282068|NCT02828111|OG000|Outcome|Patidegib Gel 2% - Cohort 1|Patidegib gel 2%, applied topically, once daily for 12 weeks (Cohort 1)
11282069|NCT02828111|OG001|Outcome|Vehicle Gel - Cohort 1|Vehicle gel, applied topically, once daily for 12 weeks (Cohort 1)
11282070|NCT02828111|OG002|Outcome|Patidegib Gel 4% - Cohort 2|Patidegib gel 4%, applied topically, once daily for 12 weeks (Cohort 2)
11282071|NCT02828111|OG003|Outcome|Vehicle Gel - Cohort 2|Vehicle gel, applied topically, once daily for 12 weeks (Cohort 2)
11282072|NCT02828111|OG004|Outcome|Patidegib Gel 2% - Cohort 3|Patidegib gel 2%, applied topically, twice daily for 12 weeks (Cohort 3)
11282073|NCT02828111|OG005|Outcome|Vehicle Gel - Cohort 3|Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3)
11282074|NCT02828111|OG006|Outcome|Patidegib Gel 4% - Cohort 4|Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4)
11282075|NCT02828111|OG007|Outcome|Vehicle Gel - Cohort 4|Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4)
11282076|NCT02828111|OG008|Outcome|Vehicle Gel - All Cohorts|Vehicle gel, applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
11282077|NCT02828111|EG000|Reported Event|Patidegib Gel 2% - Once Daily|Applied topically once daily for 12 weeks (Cohort 1)
11282078|NCT02828111|EG001|Reported Event|Patidegib Gel 4% - Once Daily|Applied topically once daily for 12 weeks (Cohort 2)
11282079|NCT02828111|EG002|Reported Event|Patidegib Gel 2% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 3)
11282080|NCT02828111|EG003|Reported Event|Patidegib Gel 4% - Twice Daily|Applied topically twice daily for 12 weeks (Cohort 4)
11282081|NCT02828111|EG004|Reported Event|Vehicle Gel|Applied topically once or twice daily for 12 weeks (Cohorts 1, 2, 3, and 4)
11282082|NCT02828137|BG000|Baseline|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
11282083|NCT02828137|BG001|Baseline|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
11282084|NCT02828137|BG002|Baseline|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
11282085|NCT02828137|BG003|Baseline|Total|Total of all reporting groups
11282086|NCT02828137|FG000|Participant Flow|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
11282087|NCT02828137|FG001|Participant Flow|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
11282088|NCT02828137|FG002|Participant Flow|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
11282089|NCT02828137|OG000|Outcome|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87
11282090|NCT02828137|OG001|Outcome|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73
11282091|NCT02828137|OG002|Outcome|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
11282092|NCT02828137|EG000|Reported Event|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
11282093|NCT02828137|EG001|Reported Event|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
11282094|NCT02828137|EG002|Reported Event|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
11282095|NCT02828241|BG000|Baseline|DFD-04 Ointment|DFD-04 (Itraconazole) Ointment
11282096|NCT02828241|BG001|Baseline|Placebo Ointment|"Placebo Ointment~t"
11282097|NCT02828241|BG002|Baseline|Total|Total of all reporting groups
11282098|NCT02828241|FG000|Participant Flow|DFD-04 Ointment|DFD-04 (Itraconazole) Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.
11282099|NCT02828241|FG001|Participant Flow|Placebo Ointment|Placebo Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.
11282100|NCT02828241|OG000|Outcome|DFD-04 Ointment|DFD-04 (Itraconazole) Ointment
11282101|NCT02828241|OG001|Outcome|Placebo Ointment|"Placebo Ointment~t"
11282102|NCT02828241|OG001|Outcome|Placebo Ointment|Placebo Ointment
11282103|NCT02828241|EG000|Reported Event|DFD-04 Ointment|DFD-04 (Itraconazole) Ointment
11282104|NCT02828241|EG001|Reported Event|Placebo Ointment|"Placebo Ointment~t"
11282105|NCT02828267|BG000|Baseline|Usual Care|In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
11282106|NCT02828267|BG001|Baseline|Brief Negotiational Interview (BNI)|"In the BNI arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use."
11282107|NCT02828267|BG002|Baseline|BNI Plus Standard Booster|"In the BNI plus standard booster arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Standard Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use."
11282108|NCT02828267|BG003|Baseline|BNI Plus Personalized Booster|"In the BNI plus personalized booster arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Personalized Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content."
11282109|NCT02828267|BG004|Baseline|Total|Total of all reporting groups
11282110|NCT02828267|FG000|Participant Flow|Usual Care|In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
11282111|NCT02828267|FG001|Participant Flow|Brief Negotiational Interview (BNI)|"In the BNI arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use."
11282112|NCT02828267|FG002|Participant Flow|BNI Plus Standard Booster|"In the BNI plus standard booster arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Standard Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use."
11282113|NCT02828267|FG003|Participant Flow|BNI Plus Personalized Booster|"In the BNI plus personalized booster arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Personalized Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content."
11282114|NCT02828267|OG000|Outcome|Total Enrolled Patient Sample|All feasibility trial arms
11282115|NCT02828267|OG000|Outcome|Usual Care|In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
11282116|NCT02828267|OG001|Outcome|BNI Only|"In the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use."
11282117|NCT02828267|OG002|Outcome|BNI Plus Standard Booster|"In the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Standard Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use."
11282118|NCT02828267|OG003|Outcome|BNI Plus Personalized Booster|"In the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Personalized Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content."
11282119|NCT02828267|OG004|Outcome|All Trial Participants|Total participants in the feasibility trial.
11282120|NCT02828267|EG000|Reported Event|Usual Care|In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
11282121|NCT02828267|EG001|Reported Event|BNI Only|"In the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use."
11282122|NCT02828267|EG002|Reported Event|BNI Plus Standard Booster|"In the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Standard Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use."
11282123|NCT02828267|EG003|Reported Event|BNI Plus Personalized Booster|"In the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.~Brief Negotiational Intervention: This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.~Personalized Booster: This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content."
11282124|NCT02828358|BG000|Baseline|KMT2A-Rearranged|INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
11282125|NCT02828358|BG001|Baseline|KMT2A-Germline|Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
11282126|NCT02828358|BG002|Baseline|Total|Total of all reporting groups
11282127|NCT02828358|FG000|Participant Flow|KMT2A-Rearranged|INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
11282128|NCT02828358|FG001|Participant Flow|KMT2A-Germline|Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
11282129|NCT02828358|OG000|Outcome|KMT2A-Rearranged|INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
11282130|NCT02828358|EG000|Reported Event|KMT2A-Rearranged|INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
11282131|NCT02828358|EG001|Reported Event|KMT2A-Germline|Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
11282132|NCT02828436|BG000|Baseline|All Participants|This is a cross-over study. All participants are pooled at baseline.
11282133|NCT02828436|FG000|Participant Flow|Spinal Cord Stimulation|"Boston Scientific Precision Spectra System~Precision Spectra System: Spinal Cord Stimulation"
11282134|NCT02828436|FG001|Participant Flow|Exercise Intervention|"If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm~Exercise Intervention: Standard Exercise"
11282135|NCT02828436|OG000|Outcome|Spinal Cord Stimulation|"Boston Scientific Precision Spectra System~Precision Spectra System: Spinal Cord Stimulation"
11282136|NCT02828436|OG001|Outcome|Exercise Intervention|"If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm~Exercise Intervention: Standard Exercise"
11282137|NCT02828436|EG000|Reported Event|Spinal Cord Stimulation|"Boston Scientific Precision Spectra System~Precision Spectra System: Spinal Cord Stimulation"
11282138|NCT02828436|EG001|Reported Event|Exercise Intervention|"If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm~Exercise Intervention: Standard Exercise"
11282139|NCT02828644|BG000|Baseline|AKL-T01 (EVO Multi)|AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282140|NCT02828644|BG001|Baseline|AKL-T09 (EVO Words)|AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282141|NCT02828644|BG002|Baseline|Total|Total of all reporting groups
11282142|NCT02828644|FG000|Participant Flow|AKL-T01 (EVO Multi)|AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282143|NCT02828644|FG001|Participant Flow|AKL-T09 (EVO Words)|AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282144|NCT02828644|OG000|Outcome|AKL-T01 (EVO Multi)|AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633).
11282145|NCT02828644|OG000|Outcome|AKL-T01 (EVO Multi)|EVO Multitasking is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282146|NCT02828644|OG001|Outcome|AKL-T09 (EVO Words)|EVO Words is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
11282147|NCT02828644|EG000|Reported Event|AKL-T01 (EVO Multi)|AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633).
11282148|NCT02828644|EG001|Reported Event|AKL-T09 (EVO Words)|AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633).
11282149|NCT02829034|BG000|Baseline|Ranolazine|"Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11282150|NCT02829034|BG001|Baseline|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks"
11282151|NCT02829034|BG002|Baseline|Total|Total of all reporting groups
11282152|NCT02829034|FG000|Participant Flow|Ranolazine|"Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11282153|NCT02829034|FG001|Participant Flow|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks"
11282154|NCT02829034|OG000|Outcome|Ranolazine|"Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11282155|NCT02829034|OG001|Outcome|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks"
11282156|NCT02829034|EG000|Reported Event|Ranolazine|"Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day~Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks."
11282157|NCT02829034|EG001|Reported Event|Placebo|"Placebo by mouth twice per day~Placebo: Placebo by mouth twice per day for a total of 26 weeks"
11282158|NCT02829138|BG000|Baseline|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
11282159|NCT02829138|BG001|Baseline|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
11282160|NCT02829138|BG002|Baseline|Total|Total of all reporting groups
11282161|NCT02829138|FG000|Participant Flow|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
11282162|NCT02829138|FG001|Participant Flow|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
11282163|NCT02829138|OG000|Outcome|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
11282164|NCT02829138|OG001|Outcome|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
11282165|NCT02829138|EG000|Reported Event|Non-genetic Group|General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
11282166|NCT02829138|EG001|Reported Event|Genetic Group|Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
11282167|NCT02829294|BG000|Baseline|Treatment|Subjects that qualify were treated per protocol
11282168|NCT02829294|FG000|Participant Flow|Treatment|Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol
11282169|NCT02829294|OG000|Outcome|Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes|"E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 1 or 2 treatments of 15 minutes~E002 - cerumen removal aid: topical treatment"
11282170|NCT02829294|OG000|Outcome|Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes|Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol
11282171|NCT02829294|OG000|Outcome|Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes|Subjects with either one or 2 ears that met the inclusion/exclusion criteria were treated with test product per protocol
11282172|NCT02829294|EG000|Reported Event|Treatment|Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol
11282173|NCT02829307|BG000|Baseline|89Zr-GSK3128349|Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
11282174|NCT02829307|FG000|Participant Flow|89Zr-GSK3128349|Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 milligram (mg).
11282175|NCT02829307|OG000|Outcome|89Zr-GSK3128349|Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
11282176|NCT02829307|EG000|Reported Event|89Zr-GSK3128349|Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
11282177|NCT02829320|BG000|Baseline|All Participants|Participants with newly started dialysis (dialysis newly started <12 weeks before screening) or with maintenance dialysis (dialysis started >=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282178|NCT02829320|FG000|Participant Flow|All Participants|Participants with newly started dialysis (dialysis newly started <12 weeks before screening) or with maintenance dialysis (dialysis started >=12 weeks before screening) received GSK1278863 orally once daily initially at 4 milligram (mg) for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain hemoglobin (Hgb) within the target range (10.0-12.0 grams per deciliter [g/dL]). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 nanogram per milliliter (ng/mL) and transferrin saturation (TSAT) is <=20%.
11282179|NCT02829320|OG000|Outcome|All Participants|Participants with newly started dialysis (dialysis newly started <12 weeks before screening) or with maintenance dialysis (dialysis started >=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282180|NCT02829320|OG000|Outcome|GSK1278863 1 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 1 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282181|NCT02829320|OG001|Outcome|GSK1278863 2 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282182|NCT02829320|OG002|Outcome|GSK1278863 4 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282183|NCT02829320|OG003|Outcome|GSK1278863 6 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282184|NCT02829320|OG004|Outcome|GSK1278863 8 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282185|NCT02829320|OG005|Outcome|GSK1278863 12 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282186|NCT02829320|OG006|Outcome|GSK1278863 18 mg|Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282187|NCT02829320|EG000|Reported Event|All Participants|Participants with newly started dialysis (dialysis newly started <12 weeks before screening) or with maintenance dialysis (dialysis started >=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is <=100 ng/mL and TSAT is <=20%.
11282188|NCT02829463|BG000|Baseline|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282189|NCT02829463|BG001|Baseline|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282190|NCT02829463|BG002|Baseline|Total|Total of all reporting groups
11282191|NCT02829463|FG000|Participant Flow|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282192|NCT02829463|FG001|Participant Flow|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282193|NCT02829463|OG000|Outcome|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282194|NCT02829463|OG001|Outcome|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282195|NCT02829463|EG000|Reported Event|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11282196|NCT02829463|EG001|Reported Event|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
11092387|NCT01539525|OG002|Outcome|Treatment as Usual|"No intervention- resource list provided.~Treatment as Usual: Subjects given a brochure listing relevant recovery resources in the local area."
11282197|NCT02829775|BG000|Baseline|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
11282198|NCT02829775|FG000|Participant Flow|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
11282199|NCT02829775|OG000|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
11282200|NCT02829775|OG000|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
11282201|NCT02829775|EG000|Reported Event|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
11282202|NCT02829944|BG000|Baseline|Placebo|"Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Placebo"
11282203|NCT02829944|BG001|Baseline|Ropivacaine|"Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Ropivacaine~Ketorolac"
11282204|NCT02829944|BG002|Baseline|Total|Total of all reporting groups
11282205|NCT02829944|FG000|Participant Flow|Placebo|"Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Placebo"
11282206|NCT02829944|FG001|Participant Flow|Ropivacaine|"Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Ropivacaine~Ketorolac"
11282207|NCT02829944|OG000|Outcome|Placebo|"Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Placebo"
11282208|NCT02829944|OG001|Outcome|Ropivacaine|"Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Ropivacaine~Ketorolac"
11282209|NCT02829944|EG000|Reported Event|Placebo|"Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Placebo"
11282210|NCT02829944|EG001|Reported Event|Ropivacaine|"Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.~Ropivacaine~Ketorolac"
11282211|NCT02829983|BG000|Baseline|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282212|NCT02829983|BG001|Baseline|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282213|NCT02829983|BG002|Baseline|Total|Total of all reporting groups
11282214|NCT02829983|FG000|Participant Flow|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282215|NCT02829983|FG001|Participant Flow|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282216|NCT02829983|OG000|Outcome|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282217|NCT02829983|OG001|Outcome|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282218|NCT02829983|EG000|Reported Event|Clarithromycin Group|"20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.~Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282219|NCT02829983|EG001|Reported Event|Placebo Group|"20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).~Placebo: Use of placebo tablets twice a day for 3 days.~One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device."
11282220|NCT02829996|BG000|Baseline|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282221|NCT02829996|BG001|Baseline|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282222|NCT02829996|BG002|Baseline|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282223|NCT02829996|BG003|Baseline|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282224|NCT02829996|BG004|Baseline|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282225|NCT02829996|BG005|Baseline|Total|Total of all reporting groups
11282226|NCT02829996|FG000|Participant Flow|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282227|NCT02829996|FG001|Participant Flow|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282228|NCT02829996|FG002|Participant Flow|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282229|NCT02829996|FG003|Participant Flow|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282230|NCT02829996|FG004|Participant Flow|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282231|NCT02829996|OG000|Outcome|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282232|NCT02829996|OG001|Outcome|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282233|NCT02829996|OG002|Outcome|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282234|NCT02829996|OG003|Outcome|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282235|NCT02829996|OG004|Outcome|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282236|NCT02829996|EG000|Reported Event|Trabodenoson 6.0% / Latanoprost 0.005% QD|"trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282237|NCT02829996|EG001|Reported Event|Trabodenoson 3.0% / Latanoprost 0.005% QD|"trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination~trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282238|NCT02829996|EG002|Reported Event|Trabodenoson 6.0% / Latanoprost 0.0025% QD|"trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination~trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282239|NCT02829996|EG003|Reported Event|Latanoprost 0.005% QD|"latanoprost 0.005% ophthalmic solution~latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282240|NCT02829996|EG004|Reported Event|Latanoprost 0.0025% QD|"latanoprost 0.0025% ophthalmic solution~latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks."
11282241|NCT02830074|BG000|Baseline|The BEST Program|"a combined sleep and PAP adherence program, called the ?BEST? program (Best practices PAP + patient Education + ongoing Support and Training)~Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + Education + ongoing Support/Training"
11282242|NCT02830074|BG001|Baseline|Sleep Education and Standard SDB Treatment|"This program includes non-directive sleep education plus standard treatment of SDB.~Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB."
11282243|NCT02830074|BG002|Baseline|Total|Total of all reporting groups
11282244|NCT02830074|FG000|Participant Flow|The BEST Program|"a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)~Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + Education + ongoing Support/Training"
11282245|NCT02830074|FG001|Participant Flow|Sleep Education and Standard SDB Treatment|"This program includes non-directive sleep education plus standard treatment of SDB.~Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB."
11282246|NCT02830074|OG000|Outcome|The BEST Program|"a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)~Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + Education + ongoing Support/Training"
11282247|NCT02830074|OG001|Outcome|Sleep Education and Standard Sleep-disordered Breathing Treatment|"This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .~Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing ."
11282248|NCT02830074|OG001|Outcome|Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment|"This program includes non-directive sleep education plus standard treatment of SDB.~Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB."
11282249|NCT02830074|EG000|Reported Event|The BEST Program|"a combined sleep and PAP adherence program, called the ?BEST? program (Best practices PAP + patient Education + ongoing Support and Training)~Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + Education + ongoing Support/Training"
11282250|NCT02830074|EG001|Reported Event|Sleep Education and Standard SDB Treatment|"This program includes non-directive sleep education plus standard treatment of SDB.~Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB."
11282251|NCT02830087|BG000|Baseline|220 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 220 mmHg.~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282252|NCT02830087|BG001|Baseline|250 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 250 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282253|NCT02830087|BG002|Baseline|275 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 275 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282254|NCT02830087|BG003|Baseline|300 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 300 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11092388|NCT01539525|EG000|Reported Event|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11282255|NCT02830087|BG004|Baseline|325 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 325 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282256|NCT02830087|BG005|Baseline|350 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 350 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282257|NCT02830087|BG006|Baseline|Total|Total of all reporting groups
11282258|NCT02830087|FG000|Participant Flow|220 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 220 mmHg.~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282259|NCT02830087|FG001|Participant Flow|250 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 250 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282260|NCT02830087|FG002|Participant Flow|275 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 275 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282261|NCT02830087|FG003|Participant Flow|300 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 300 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282262|NCT02830087|FG004|Participant Flow|325 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 325 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282263|NCT02830087|FG005|Participant Flow|350 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 350 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282264|NCT02830087|OG000|Outcome|220 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 220 mmHg.~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282265|NCT02830087|OG001|Outcome|250 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 250 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282266|NCT02830087|OG002|Outcome|275 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 275 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282267|NCT02830087|OG003|Outcome|300 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 300 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282268|NCT02830087|OG004|Outcome|325 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 325 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282269|NCT02830087|OG005|Outcome|350 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 350 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282270|NCT02830087|EG000|Reported Event|220 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 220 mmHg.~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282271|NCT02830087|EG001|Reported Event|250 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 250 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282272|NCT02830087|EG002|Reported Event|275 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 275 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282273|NCT02830087|EG003|Reported Event|300 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 300 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282274|NCT02830087|EG004|Reported Event|325 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 325 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282275|NCT02830087|EG005|Reported Event|350 mmHg Tourniquet Cuff Pressure|"Thigh tourniquet cuff inflated to 350 mmHg~Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery."
11282276|NCT02830438|BG000|Baseline|Shear Wave Elastography Group|"Patients referred for kidney biopsy will then undergo shear wave elastography measurements.~Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography."
11282277|NCT02830438|FG000|Participant Flow|Shear Wave Elastography Group|"Patients referred for kidney biopsy will then undergo shear wave elastography measurements.~Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography."
11282278|NCT02830438|OG000|Outcome|Shear Wave Elastography Group|"Patients referred for kidney biopsy will then undergo shear wave elastography measurements.~Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography."
11282279|NCT02830438|EG000|Reported Event|Shear Wave Elastography Group|"Patients referred for kidney biopsy will then undergo shear wave elastography measurements.~Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography."
11282280|NCT02830776|BG000|Baseline|Treatment Group|Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
11282281|NCT02830776|FG000|Participant Flow|Treatment Group|"This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).~bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)"
11282282|NCT02830776|OG000|Outcome|Treatment Group|Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
11282283|NCT02830776|OG000|Outcome|Treatment Group|"This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).~bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)"
11282284|NCT02830776|EG000|Reported Event|Treatment Group|"This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).~bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)"
11282285|NCT02830880|BG000|Baseline|FACBC PET-CT|Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan.
11282286|NCT02830880|FG000|Participant Flow|FACBC PET-CT|Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC) radiotracer intravenously prior to positron emission tomography (PET) scan.
11282287|NCT02830880|OG000|Outcome|FACBC PET-CT|Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan.
11282288|NCT02830880|EG000|Reported Event|FACBC PET-CT|Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan.
11337691|NCT03591146|FG003|Participant Flow|TLC590 475mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11282289|NCT02830893|BG000|Baseline|The LARA Therapy|"The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.~LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282290|NCT02830893|BG001|Baseline|The Standard Therapy|"The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.~Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282291|NCT02830893|BG002|Baseline|Total|Total of all reporting groups
11282292|NCT02830893|FG000|Participant Flow|The LARA Therapy|"The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.~LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282293|NCT02830893|FG001|Participant Flow|The Standard Therapy|"The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.~Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282294|NCT02830893|OG000|Outcome|The LARA Therapy|"The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.~LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282295|NCT02830893|OG001|Outcome|The Standard Therapy|"The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.~Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282296|NCT02830893|EG000|Reported Event|The LARA Therapy|"The LARA arm of this study will use the LARA system while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. LARA is a system that facilitates patients to perform high amounts of arm movement with the affected upper extremity. Study participants are able to actively propel themselves in the unit.~LARA: Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282297|NCT02830893|EG001|Reported Event|The Standard Therapy|"The control arm of this study will use a standard wheelchair while study participants are staying at the acute rehabilitation unit of UC Irvine Douglas Hospital. Study participants will have no exposure to LARA and they will use a standard wheelchair. They will use their unaffected upper and lower extremities to propel themselves in the unit.~Standard: Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay."
11282298|NCT02831387|BG000|Baseline|Placebo Ophthalmic Solution|Subject received Placebo TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282299|NCT02831387|BG001|Baseline|0.017% P-321 Ophthalmic Solution|Subjects received 0.017% P-321 Ophthalmic Solution TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282300|NCT02831387|BG002|Baseline|Total|Total of all reporting groups
11282301|NCT02831387|FG000|Participant Flow|Placebo Ophthalmic Solution|Subject received Placebo TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282302|NCT02831387|FG001|Participant Flow|0.017% P-321 Ophthalmic Solution|Subjects received 0.017% P-321 Ophthalmic Solution TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282303|NCT02831387|OG000|Outcome|Placebo Ophthalmic Solution|Subject received Placebo TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282304|NCT02831387|OG001|Outcome|0.017% P-321 Ophthalmic Solution|Subjects received 0.017% P-321 Ophthalmic Solution TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11282305|NCT02831387|EG000|Reported Event|0.017% P-321 Ophthalmic Solution|Subjects received 0.017% P-321 Ophthalmic Solution TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11092389|NCT01539525|EG001|Reported Event|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
11282306|NCT02831387|EG001|Reported Event|Placebo Ophthalmic Solution|Subject received Placebo TID administration in both eyes from Visit 2 (Randomization - Treatment Day 1) through the day before Visit 4 (Treatment Day 29)
11287113|NCT02898103|OG000|Outcome|Electrical Current|"electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes~Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current)."
11287114|NCT02898103|OG001|Outcome|Placebo|"NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes~Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current)."
11287115|NCT02898103|OG000|Outcome|Electrical Current|electrical current will be introduced to the insulated percutaneous lead for 5 minutes
11287116|NCT02898103|OG001|Outcome|Placebo|NO electrical current will be introduced to the insulated percutaneous lead for 5 minutes
11287117|NCT02898103|OG000|Outcome|Active Then Sham Then Active|electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes, then sham for 5 minutes, then active current for 2-4 weeks
11287118|NCT02898103|OG001|Outcome|Sham Then Active Electrical Current|sham will be given for 5 minutes followed by active current for 2-4 weeks
11287119|NCT02898103|EG000|Reported Event|Stimulation|active electrical stimulation for 5 minutes followed by 5 minutes of sham and then 2-4 weeks of active electrical stimulation
11287120|NCT02898103|EG001|Reported Event|Sham|sham for 5 minutes followed by 5 minutes of active electrical stimulation and then 2-4 weeks of active electrical stimulation
11287121|NCT02898116|BG000|Baseline|Ensartinib (200 mg)|Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
11287122|NCT02898116|FG000|Participant Flow|Ensartinib (200 mg)|Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
11287123|NCT02898116|OG000|Outcome|Ensartinib (200 mg)|Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
11287124|NCT02898116|EG000|Reported Event|Ensartinib (200 mg)|Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
11287125|NCT02898454|BG000|Baseline|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287126|NCT02898454|BG001|Baseline|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
11287127|NCT02898454|BG002|Baseline|Dupilumab 300mg q2w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287128|NCT02898454|BG003|Baseline|Total|Total of all reporting groups
11287129|NCT02898454|FG000|Participant Flow|Placebo|Placebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose.
11287130|NCT02898454|FG001|Participant Flow|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg every 4 weeks (q4w) until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
11287131|NCT02898454|FG002|Participant Flow|Dupilumab 300 mg q2w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287132|NCT02898454|OG000|Outcome|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287133|NCT02898454|OG001|Outcome|Dupilumab 300 mg (24 Weeks Pooled Arm)|Pooled arm consisted of all participants from both dupilumab treatment arms up to 24 weeks as both arms to this time point used the 300 mg q2w regimen.
11287134|NCT02898454|OG001|Outcome|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
11287135|NCT02898454|OG002|Outcome|Dupilumab 300 mg q2w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287136|NCT02898454|OG001|Outcome|Dupilumab 300 mg (Pooled Arm)|Pooled arm consisted of all participants who either received Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 or Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52, added to background therapy of intranasal MFNS at stable dose.
11287137|NCT02898454|OG000|Outcome|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. One participant randomized to dupilumab 300 mg q2w arm received 1 dose of placebo and was counted in the 300 mg q2w then q4w arm.
11287138|NCT02898454|OG001|Outcome|Dupilumab 300 mg q2w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11282307|NCT02831569|BG000|Baseline|Loxoprofen Sodium/Methocarbamol [FDC]|"The subjects were administered 2 Loxoprofen sodium/methocarbamol combination [Fixed Dose Combination (FDC)] film-coated tablets orally 3 times daily after each meal for 2 weeks.~Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg."
11282308|NCT02831569|FG000|Participant Flow|Loxoprofen Sodium/Methocarbamol [FDC]|"The subjects were administered 2 Loxoprofen sodium/methocarbamol combination [Fixed Dose Combination (FDC)] film-coated tablets orally 3 times daily after each meal for 2 weeks.~Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg."
11282309|NCT02831569|OG000|Outcome|Loxoprofen Sodium/Methocarbamol [FDC]|"The subjects were administered 2 Loxoprofen sodium/methocarbamol combination [Fixed Dose Combination (FDC)] film-coated tablets orally 3 times daily after each meal for 2 weeks.~Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg."
11282310|NCT02831569|EG000|Reported Event|Loxoprofen Sodium/Methocarbamol [FDC]|"The subjects were administered 2 Loxoprofen sodium/methocarbamol combination [Fixed Dose Combination (FDC)] film-coated tablets orally 3 times daily after each meal for 2 weeks.~Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg."
11282311|NCT02831660|BG000|Baseline|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
11282312|NCT02831660|FG000|Participant Flow|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
11282313|NCT02831660|OG000|Outcome|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
11282314|NCT02831660|EG000|Reported Event|Idarucizumab 5 g|The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.
11282315|NCT02831816|BG000|Baseline|Treated Population|Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 640 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 cfu/cm^2 baseline requirements.
11282316|NCT02831816|FG000|Participant Flow|All Participants|"ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle~Applied topically to ab (for 30 seconds) or groin (for 2 minutes)."
11282317|NCT02831816|OG000|Outcome|Mean Log Reduction - ZP (70% IPA) - Groin|"Isopropyl alcohol (IPA) 70%~ZuraPrep: Apply topically to groin."
11282318|NCT02831816|OG001|Outcome|Mean Log Reduction - Groin - ChloraPrep|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically to groin."
11282319|NCT02831816|OG002|Outcome|Mean Log Reduction - Groin - ZP Vehicle|"ZP without IPA~ZP Vehicle: Apply topically to the groin."
11282320|NCT02831816|OG000|Outcome|Mean Log Reduction - ZP (70% IPA) - Abdomen|"Isopropyl alcohol (IPA) 70%~ZuraPrep: Apply topically to abdomen."
11282321|NCT02831816|OG001|Outcome|Mean Log Reduction - Abdomen - ChloraPrep|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically to Abdomen."
11282322|NCT02831816|OG002|Outcome|Mean Log Reduction - Abdomen - ZP Vehicle|"ZP without IPA~ZP Vehicle: Apply topically to the Abdomen."
11282323|NCT02831816|EG000|Reported Event|ZP (70% IPA)|"Isopropyl alcohol (IPA) 70%~ZuraPrep: Apply topically."
11282324|NCT02831816|EG001|Reported Event|ChloraPrep|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically."
11282325|NCT02831816|EG002|Reported Event|ZP Vehicle|"ZP without IPA~ZP Vehicle: Apply topically."
11282326|NCT02831855|BG000|Baseline|Open Label: Tofacitinib 11 mg + Methotrexate|Participants with moderate to severe rheumatoid arthritis (RA) and who were insufficiently responding to their stable dose of methotrexate treatment previous to enrollment in this study, received Tofacitinib modified release (MR) 11 milligram (mg) tablet once daily (QD) with methotrexate at their previous stable dose for 24 weeks in open label phase (OL).
11282327|NCT02831855|FG000|Participant Flow|Open Label: Tofacitinib 11 mg + Methotrexate|Participants with moderate to severe rheumatoid arthritis (RA) and who were insufficiently responding to their stable dose of methotrexate treatment previous to enrollment in this study, received Tofacitinib modified release (MR) 11 milligram (mg) tablet once daily (QD) with methotrexate at their previous stable dose for 24 weeks in open label phase (OL).
11282328|NCT02831855|FG001|Participant Flow|Double Blind: Tofacitinib 11 mg + Methotrexate Placebo|Participants with low disease activity (LDA) at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with matching placebo to blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282329|NCT02831855|FG002|Participant Flow|Double Blind: Tofacitinib 11mg + Methotrexate|Participants with LDA at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282330|NCT02831855|OG000|Outcome|Double Blind: Tofacitinib 11 mg + Methotrexate Placebo|Participants with low disease activity (LDA) at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with matching placebo to blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282331|NCT02831855|OG001|Outcome|Double Blind: Tofacitinib 11mg + Methotrexate|Participants with LDA at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11337692|NCT03591146|FG004|Participant Flow|Naropin 150mg|"Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial~Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL"
11282332|NCT02831855|OG000|Outcome|Open Label: Tofacitinib 11 mg + Methotrexate|Participants with moderate to severe rheumatoid arthritis (RA) and who were insufficiently responding to their stable dose of methotrexate treatment previous to enrollment in this study, received Tofacitinib modified release (MR) 11 milligram (mg) tablet once daily (QD) with methotrexate at their previous stable dose for 24 weeks in open label phase (OL).
11282333|NCT02831855|OG001|Outcome|Double Blind: Tofacitinib 11 mg + Methotrexate Placebo|Participants with low disease activity (LDA) at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with matching placebo to blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282334|NCT02831855|OG002|Outcome|Double Blind: Tofacitinib 11mg + Methotrexate|Participants with LDA at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282335|NCT02831855|EG000|Reported Event|Open Label: Tofacitinib 11 mg + Methotrexate|Participants with moderate to severe rheumatoid arthritis (RA) and who were insufficiently responding to their stable dose of methotrexate treatment previous to enrollment in this study, received Tofacitinib modified release (MR) 11 milligram (mg) tablet once daily (QD) with methotrexate at their previous stable dose for 24 weeks in open label phase (OL).
11282336|NCT02831855|EG001|Reported Event|Double Blind: Tofacitinib 11 mg + Methotrexate Placebo|Participants with low disease activity (LDA) at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with matching placebo to blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282337|NCT02831855|EG002|Reported Event|Double Blind: Tofacitinib 11mg + Methotrexate|Participants with LDA at the end of open label phase were randomized to receive Tofacitinib MR 11 mg tablet once daily with blinded methotrexate at their previously stabilized dose for 24 weeks in double blind phase.
11282338|NCT02831998|BG000|Baseline|Treated Population|Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 440 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 baseline requirements.
11282339|NCT02831998|FG000|Participant Flow|All Participants|ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle Applied topically to ab (for 30 seconds) or groin (for 2 minutes).
11282340|NCT02831998|OG000|Outcome|Mean Log Reduction - ZP (70% IPA) - Groin|"Isopropyl alcohol (IPA) 70%~ZP: Apply topically."
11282341|NCT02831998|OG001|Outcome|Mean Log Reduction - ChloraPrep - Groin|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically."
11282342|NCT02831998|OG002|Outcome|Mean Log Reduction - ZP Vehicle - Groin|"ZP without IPA~ZP Vehicle: Apply topically."
11282343|NCT02831998|OG000|Outcome|Mean Log Reduction - ZP (70% IPA) - Abdomen|"Isopropyl alcohol (IPA) 70%~ZP: Apply topically."
11282344|NCT02831998|OG001|Outcome|Mean Log Reduction - ChloraPrep - Abdomen|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically."
11282345|NCT02831998|OG002|Outcome|Mean Log Reduction - ZP Vehicle - Abdomen|"ZP without IPA~ZP Vehicle: Apply topically."
11282346|NCT02831998|EG000|Reported Event|ZP (70% IPA)|"Isopropyl alcohol (IPA) 70%~ZP: Apply topically."
11282347|NCT02831998|EG001|Reported Event|ChloraPrep|"Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%~ChloraPrep: Apply topically."
11282348|NCT02831998|EG002|Reported Event|ZP Vehicle|"ZP without IPA~ZP Vehicle: Apply topically."
11282349|NCT02832037|BG000|Baseline|BI 425809 2 mg Once a Day (q.d.)|2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282350|NCT02832037|BG001|Baseline|BI 425809 5 mg q.d.|5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282351|NCT02832037|BG002|Baseline|BI 425809 10 mg q.d.|10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
11282352|NCT02832037|BG003|Baseline|BI 425809 25 mg q.d.|25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282353|NCT02832037|BG004|Baseline|Placebo q.d.|Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282354|NCT02832037|BG005|Baseline|Total|Total of all reporting groups
11282355|NCT02832037|FG000|Participant Flow|BI 425809 2 mg Once a Day (q.d.)|2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282356|NCT02832037|FG001|Participant Flow|BI 425809 5 mg q.d.|5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282357|NCT02832037|FG002|Participant Flow|BI 425809 10 mg q.d.|10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
11282358|NCT02832037|FG003|Participant Flow|BI 425809 25 mg q.d.|25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282359|NCT02832037|FG004|Participant Flow|Placebo q.d.|Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282360|NCT02832037|OG000|Outcome|BI 425809 2 mg Once a Day (q.d.)|2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282361|NCT02832037|OG001|Outcome|BI 425809 5 mg q.d.|5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282362|NCT02832037|OG002|Outcome|BI 425809 10 mg q.d.|10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
11282363|NCT02832037|OG003|Outcome|BI 425809 25 mg q.d.|25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282364|NCT02832037|OG004|Outcome|Placebo q.d.|Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282365|NCT02832037|EG000|Reported Event|BI 425809 2 mg Once a Day (q.d.)|2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282366|NCT02832037|EG001|Reported Event|BI 425809 5 mg q.d.|5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282367|NCT02832037|EG002|Reported Event|BI 425809 10 mg q.d.|10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
11282368|NCT02832037|EG003|Reported Event|BI 425809 25 mg q.d.|25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282369|NCT02832037|EG004|Reported Event|Placebo q.d.|Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
11282370|NCT02832115|BG000|Baseline|Study|"40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282371|NCT02832115|BG001|Baseline|Control|"40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282372|NCT02832115|BG002|Baseline|Total|Total of all reporting groups
11282373|NCT02832115|FG000|Participant Flow|Study|"40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282374|NCT02832115|FG001|Participant Flow|Control|"40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282375|NCT02832115|OG000|Outcome|Study|"40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282376|NCT02832115|OG001|Outcome|Control|"40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282377|NCT02832115|EG000|Reported Event|Study|"40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282378|NCT02832115|EG001|Reported Event|Control|"40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.~Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms"
11282379|NCT02832154|BG000|Baseline|Supportive Care|"Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.~Internet-Based Intervention: Complete online PA program~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11282380|NCT02832154|FG000|Participant Flow|Supportive Care|"Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.~Internet-Based Intervention: Complete online PA program~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11282381|NCT02832154|OG000|Outcome|Supportive Care|"Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.~Internet-Based Intervention: Complete online PA program~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11282382|NCT02832154|EG000|Reported Event|Supportive Care|"Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.~Internet-Based Intervention: Complete online PA program~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
11282383|NCT02832284|BG000|Baseline|iNod System|"Multi-center, Prospective, Single-arm Feasibility Study with Salvage.~iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.~Per, protocol, each of the 23 enrolled subjects underwent evaluations with the iNod System.~For study subjects for whom an adequate specimen, defined as a specimen that has been confirmed as suitable for cytologic evaluation, is not obtained from the iNod System diagnostic procedure but for whom continuation with endobronchial maneuvers are not contraindicated, additional standard of care (SOC) R-EBUS-guided diagnostic sampling maneuvers should be conducted."
11282384|NCT02832284|FG000|Participant Flow|iNod System|"Multi-center, Prospective, Single-arm Feasibility Study with Salvage.~iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree."
11282385|NCT02832284|OG000|Outcome|iNod System|"Multi-center, Prospective, Single-arm Feasibility Study with Salvage.~iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree."
11282386|NCT02832284|EG000|Reported Event|iNod System|"Multi-center, Prospective, Single-arm Feasibility Study with Salvage.~iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree."
11282387|NCT02832375|BG000|Baseline|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282388|NCT02832375|BG001|Baseline|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282389|NCT02832375|BG002|Baseline|Total|Total of all reporting groups
11282390|NCT02832375|FG000|Participant Flow|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282391|NCT02832375|FG001|Participant Flow|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282392|NCT02832375|OG000|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282393|NCT02832375|OG001|Outcome|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282394|NCT02832375|OG001|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282395|NCT02832375|EG000|Reported Event|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282396|NCT02832375|EG001|Reported Event|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
11282397|NCT02832622|BG000|Baseline|MPP Group|MPP Group: Subjects programmed with MPP in the study are included in the analysis population.
11282398|NCT02832622|FG000|Participant Flow|MPP Programming|Data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
11282399|NCT02832622|OG000|Outcome|MPP Group|Subjects programmed with MPP in the study are included in the analysis population.
11282400|NCT02832622|OG000|Outcome|MPP Programming|Overall mortality rate for all subjects who started the trial is summarized.
11282401|NCT02832622|EG000|Reported Event|Overall Study Cohort|All patients who started in the study are included in the all-cause mortality, serious adverse events and/or other adverse events tables.
11282402|NCT02832674|BG000|Baseline|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
11282403|NCT02832674|FG000|Participant Flow|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
11282404|NCT02832674|OG000|Outcome|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
11282405|NCT02832674|EG000|Reported Event|Single Treatment|"All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'~Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."
11282406|NCT02833077|BG000|Baseline|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282407|NCT02833077|BG001|Baseline|No Treatment Then JUVÉDERM VOLUMA® XC|No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282408|NCT02833077|BG002|Baseline|Total|Total of all reporting groups
11092390|NCT01539525|EG002|Reported Event|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
11282409|NCT02833077|FG000|Participant Flow|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.
11282410|NCT02833077|FG001|Participant Flow|No Treatment Then JUVÉDERM VOLUMA® XC|No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282411|NCT02833077|OG000|Outcome|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282412|NCT02833077|OG001|Outcome|No Treatment Then JUVÉDERM VOLUMA® XC|No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282413|NCT02833077|EG000|Reported Event|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282414|NCT02833077|EG001|Reported Event|No Treatment|Participants who received no treatment for the first 6 months.
11282415|NCT02833077|EG002|Reported Event|JUVÉDERM VOLUMA® XC After No Treatment|Participants who received optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6 after no treatment for 6 months. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.
11282416|NCT02833337|BG000|Baseline|Consecutive Individuals|Consecutive individuals explored via cone-beam computed tomography to evaluate the anatomical features
11282417|NCT02833337|FG000|Participant Flow|Consecutive Individuals|Consecutive individuals explored via cone-beam computed tomography to evaluate the anatomical features
11282418|NCT02833337|OG000|Outcome|Consecutive Individuals|Consecutive individuals explored via cone-beam computed tomography to evaluate the anatomical features
11282419|NCT02833337|EG000|Reported Event|No Adverse Events Were Monitored|Adverse events were not monitored
11282420|NCT02833350|BG000|Baseline|Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282421|NCT02833350|BG001|Baseline|Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282422|NCT02833350|BG002|Baseline|Cohort 1: GDC-0853 High Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282423|NCT02833350|BG003|Baseline|Cohort 1: GDC-0853 Placebo + Adalimumab Placebo|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282424|NCT02833350|BG004|Baseline|Cohort 1: GDC-0853 Placebo + Adalimumab|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282425|NCT02833350|BG005|Baseline|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282426|NCT02833350|BG006|Baseline|Cohort 2: GDC-0853 Placebo|Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282427|NCT02833350|BG007|Baseline|Total|Total of all reporting groups
11282428|NCT02833350|FG000|Participant Flow|Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282429|NCT02833350|FG001|Participant Flow|Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282430|NCT02833350|FG002|Participant Flow|Cohort 1: GDC-0853 High Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282431|NCT02833350|FG003|Participant Flow|Cohort 1: GDC-0853 Placebo + Adalimumab Placebo|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282432|NCT02833350|FG004|Participant Flow|Cohort 1: GDC-0853 Placebo + Adalimumab|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282433|NCT02833350|FG005|Participant Flow|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282434|NCT02833350|FG006|Participant Flow|Cohort 2: GDC-0853 Placebo|Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282435|NCT02833350|OG000|Outcome|Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282436|NCT02833350|OG001|Outcome|Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11287139|NCT02898454|OG001|Outcome|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. Two participants randomized to placebo arm accidently received 1 dose of dupilumab 300 mg and counted in the 300 mg q2w then q4w arm. One participant randomized to the dupilumab 300 mg q2w arm received 1 dose of placebo and was counted in the 300 mg q2w then q4w arm.
11092391|NCT01539538|BG000|Baseline|Sufentanil NanoTab PCA System/15 mcg|
11092392|NCT01539538|BG001|Baseline|Morphine IV PCA|
11092393|NCT01539538|BG002|Baseline|Total|Total of all reporting groups
11092394|NCT01539538|FG000|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|
11092395|NCT01539538|FG001|Participant Flow|Morphine IV PCA|
11282437|NCT02833350|OG002|Outcome|Cohort 1: GDC-0853 High Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282438|NCT02833350|OG003|Outcome|Cohort 1: GDC-0853 Placebo + Adalimumab Placebo|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282439|NCT02833350|OG004|Outcome|Cohort 1: GDC-0853 Placebo + Adalimumab|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282440|NCT02833350|OG005|Outcome|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282441|NCT02833350|OG006|Outcome|Cohort 2: GDC-0853 Placebo|Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282442|NCT02833350|OG000|Outcome|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282443|NCT02833350|OG001|Outcome|Cohort 2: GDC-0853 Placebo|Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282444|NCT02833350|OG003|Outcome|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282445|NCT02833350|EG000|Reported Event|Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282446|NCT02833350|EG001|Reported Event|Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11287140|NCT02898454|EG000|Reported Event|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287141|NCT02898454|EG001|Reported Event|Dupilumab 300 mg q2w Then q4w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50.
11092396|NCT01539538|OG000|Outcome|Sufentanil NanoTab PCA System/15 mcg|
11282447|NCT02833350|EG002|Reported Event|Cohort 1: GDC-0853 High Dose + Adalimumab Placebo|Participants of Cohort 1 received GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282448|NCT02833350|EG003|Reported Event|Cohort 1: GDC-0853 Placebo + Adalimumab Placebo|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282449|NCT02833350|EG004|Reported Event|Cohort 1: GDC-0853 Placebo + Adalimumab|Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282450|NCT02833350|EG005|Reported Event|Cohort 2: GDC-0853 High Dose|Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282451|NCT02833350|EG006|Reported Event|Cohort 2: GDC-0853 Placebo|Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion.
11282452|NCT02833415|BG000|Baseline|Empagliflozin|"Empagliflozin 10 mg by mouth daily for 3 months.~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Empagliflozin: Active drug"
11282453|NCT02833415|BG001|Baseline|Placebo|"Placebo one tablet daily for 3 months~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet."
11282454|NCT02833415|BG002|Baseline|Total|Total of all reporting groups
11282455|NCT02833415|FG000|Participant Flow|Empagliflozin|"Empagliflozin 10 mg by mouth daily for 3 months.~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Empagliflozin: Active drug"
11282456|NCT02833415|FG001|Participant Flow|Placebo|"Placebo one tablet daily for 3 months~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet."
10820423|NCT00057863|FG000|Participant Flow|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
11282457|NCT02833415|OG000|Outcome|Empagliflozin|"Empagliflozin 10 mg by mouth daily for 3 months.~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Empagliflozin: Active drug"
11282458|NCT02833415|OG001|Outcome|Placebo|"Placebo one tablet daily for 3 months~[U-13C3] glycerol: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).~Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet."
11282459|NCT02833415|EG000|Reported Event|Empagliflozin|Empagliflozin 10 mg daily by mouth
11282460|NCT02833415|EG001|Reported Event|Placebo|Placebo daily by mouth
11282461|NCT02833857|BG000|Baseline|Etelcalcetide|Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
11282462|NCT02833857|FG000|Participant Flow|Etelcalcetide|Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
11282463|NCT02833857|OG000|Outcome|Etelcalcetide|Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
11282464|NCT02833857|EG000|Reported Event|Etelcalcetide|Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
11092397|NCT01539538|OG001|Outcome|Morphine IV PCA|
11092398|NCT01539538|EG000|Reported Event|Sufentanil NanoTab PCA System/15 mcg|
11092399|NCT01539538|EG001|Reported Event|Morphine IV PCA|
11282465|NCT02833922|BG000|Baseline|Women Using Dot to Avoid Pregnancy|"Women living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year.~Women using Dot to avoid pregnancy: Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method."
11282466|NCT02833922|FG000|Participant Flow|Women Using Dot to Avoid Pregnancy|"Women living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year.~Women using Dot to avoid pregnancy: Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method."
11282467|NCT02833922|OG000|Outcome|Women Using Dot to Avoid Pregnancy|"Women living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year.~Women using Dot to avoid pregnancy: Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method."
11282468|NCT02833922|EG000|Reported Event|Women Using Dot to Avoid Pregnancy|"Women living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year.~Women using Dot to avoid pregnancy: Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method."
11282469|NCT02833948|BG000|Baseline|ASA + Clopidogrel|"ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days~If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3."
11282470|NCT02833948|BG001|Baseline|Rivaroxaban + ASA|"Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Rivaroxaban: Drug: Rivaroxaban (Xarelto):~10 mg OD (once-daily)~If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR."
11282471|NCT02833948|BG002|Baseline|Total|Total of all reporting groups
11282472|NCT02833948|FG000|Participant Flow|ASA + Clopidogrel|"ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days~If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3."
11282473|NCT02833948|FG001|Participant Flow|Rivaroxaban + ASA|"Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Rivaroxaban: Drug: Rivaroxaban (Xarelto):~10 mg OD (once-daily)~If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR."
11282474|NCT02833948|OG000|Outcome|ASA + Clopidogrel|"ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days~If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3."
11282475|NCT02833948|OG001|Outcome|Rivaroxaban + ASA|"Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Rivaroxaban: Drug: Rivaroxaban (Xarelto):~10 mg OD (once-daily)~If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR."
11282476|NCT02833948|OG000|Outcome|HALT (-)|Hypoattenuated leaflet thickening (-)
11282477|NCT02833948|OG001|Outcome|HALT (+)|Hypoattenuated leaflet thickening (+)
11282478|NCT02833948|OG000|Outcome|RLM>2 (-)|Reduced Leaflet Motion >2 (-)
11282479|NCT02833948|OG001|Outcome|RLM(+)|Reduced Leaflet Motion >2 (+)
11282480|NCT02833948|EG000|Reported Event|ASA + Clopidogrel|"ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days~If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3."
11287142|NCT02898454|EG002|Reported Event|Dupilumab 300 mg q2w|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 52 added to background therapy of intranasal MFNS at stable dose.
11287143|NCT02898597|BG000|Baseline|Video|This is the group that received the cognitive behavioral therapy for smoking cessation via video calls.
11282481|NCT02833948|EG001|Reported Event|Rivaroxaban + ASA|"Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy~Acetylsalicylic acid: Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)~Rivaroxaban: Drug: Rivaroxaban (Xarelto):~10 mg OD (once-daily)~If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR."
11282482|NCT02833974|BG000|Baseline|Placebo|Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
11282483|NCT02833974|BG001|Baseline|GSK2245035 20 ng|Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
11282484|NCT02833974|BG002|Baseline|Total|Total of all reporting groups
11282485|NCT02833974|FG000|Participant Flow|Placebo|Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
11282486|NCT02833974|FG001|Participant Flow|GSK2245035 20 ng|Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
11282487|NCT02833974|OG000|Outcome|Placebo|Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
11282488|NCT02833974|OG001|Outcome|GSK2245035 20 ng|Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
11282489|NCT02833974|EG000|Reported Event|Placebo|Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
11282490|NCT02833974|EG001|Reported Event|GSK2245035 20 ng|Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
11282491|NCT02834247|BG000|Baseline|Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg|TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282492|NCT02834247|BG001|Baseline|Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282493|NCT02834247|BG002|Baseline|Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg|TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282494|NCT02834247|BG003|Baseline|Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
11282495|NCT02834247|BG004|Baseline|Total|Total of all reporting groups
11282496|NCT02834247|FG000|Participant Flow|Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg|TAK-659 60 milligram (mg), tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 milligram per kilogram (mg/kg), infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until progressive disease (PD) or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282497|NCT02834247|FG001|Participant Flow|Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282498|NCT02834247|FG002|Participant Flow|Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg|TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282499|NCT02834247|FG003|Participant Flow|Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic triple negative breast cancer (TNBC).
11282500|NCT02834247|OG000|Outcome|Part 1: Dose Escalation Participants|TAK-659 60 mg, 80 mg or 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48).
11282501|NCT02834247|OG000|Outcome|Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
11282502|NCT02834247|OG000|Outcome|Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg|TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282503|NCT02834247|OG001|Outcome|Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282504|NCT02834247|OG002|Outcome|Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg|TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11287144|NCT02898597|BG001|Baseline|Voice|This is the group that received the cognitive behavioral therapy for smoking cessation via voice calls.
11287145|NCT02898597|BG002|Baseline|Total|Total of all reporting groups
11282505|NCT02834247|OG003|Outcome|Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
11282506|NCT02834247|EG000|Reported Event|Part 1: TAK-659 60 mg + Nivolumab 3 mg/kg|TAK-659 60 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282507|NCT02834247|EG001|Reported Event|Part 1: TAK-659 80 mg + Nivolumab 3 mg/kg|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282508|NCT02834247|EG002|Reported Event|Part 1: TAK-659 100 mg + Nivolumab 3 mg/kg|TAK-659 100 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 48) in Dose Escalation Phase.
11282509|NCT02834247|EG003|Reported Event|Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC)|TAK-659 80 mg, tablets, orally, once daily in each 28-days treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Days 1 and 15 in each 28-days treatment cycle until PD or unacceptable toxicity (up to Week 13) in Dose Expansion Phase in participants with metastatic TNBC.
11282510|NCT02834390|BG000|Baseline|Quizartinib 20 mg/Day|"Participants who received 20 mg quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282511|NCT02834390|BG001|Baseline|Quizartinib 40 mg/Day|"Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282512|NCT02834390|BG002|Baseline|Total|Total of all reporting groups
11282513|NCT02834390|FG000|Participant Flow|Quizartinib 20 mg/Day|"Participants who received 20 mg quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282514|NCT02834390|FG001|Participant Flow|Quizartinib 40 mg/Day|"Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282515|NCT02834390|OG000|Outcome|Quizartinib 20 mg/Day|"Participants who received 20 mg quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282516|NCT02834390|OG001|Outcome|Quizartinib 40 mg/Day|"Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282517|NCT02834390|EG000|Reported Event|Quizartinib 20 mg/Day|"Participants who received 20 mg quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282518|NCT02834390|EG001|Reported Event|Quizartinib 40 mg/Day|"Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions.~For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib.~For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib."
11282519|NCT02834624|BG000|Baseline|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282520|NCT02834624|BG001|Baseline|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282521|NCT02834624|BG002|Baseline|Total|Total of all reporting groups
11282522|NCT02834624|FG000|Participant Flow|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282523|NCT02834624|FG001|Participant Flow|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282524|NCT02834624|OG000|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282525|NCT02834624|OG001|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282526|NCT02834624|OG000|Outcome|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
11282527|NCT02834624|EG000|Reported Event|Calfactant|"Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~calfactant: Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist"
11282528|NCT02834624|EG001|Reported Event|Poractant Alfa|"Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~Poractant alfa: Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist."
11282529|NCT02834663|BG000|Baseline|Baseline Characteristics|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study
11282530|NCT02834663|FG000|Participant Flow|Lucentis(Ranivizumab)|25 eyes of 25 type 2 diabetes mellitus patients with macular edema were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg intra-vitreal Lucentis(Ranibizumab) injections monthly.
11282531|NCT02834663|OG000|Outcome|BCVA Baseline|Before the treatment regimen, assessment of BCVA using the ETDRS charts.
11282532|NCT02834663|OG001|Outcome|BCVA Resulte|After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
11282533|NCT02834663|OG000|Outcome|CRT Baseline|Before the treatment regimen, assessment of CRT using the OCT.
11282534|NCT02834663|OG001|Outcome|CRT Resulte|After the treatment regimen during 6 months, assessment of CRT using the OCT.
11282535|NCT02834663|OG000|Outcome|Total MA Baseline|The number of MAs in individual retinas were evaluated at first visit using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs.
11282536|NCT02834663|OG001|Outcome|Total MA Resulte|The number of MAs in individual retinas were evaluated during 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs.
11282537|NCT02834663|OG000|Outcome|The MA Formation Rate Baseline|The Retmarker software was used for automatic measurement and analysis of MA formation at first visit.
11282538|NCT02834663|OG001|Outcome|The MA Formation Rate Resulte|The Retmarker software was used for automatic measurement and analysis of MA formation during monthly 6 months
11282539|NCT02834663|OG000|Outcome|The MA Disappearance Rate Baseline|The Retmarker software was used for automatic measurement and analysis of MA disappearance at first visit.
11282540|NCT02834663|OG001|Outcome|The MA Disappearance Rate Resulte|The Retmarker software was used for automatic measurement and analysis of MA disappearance during monthly 6 months.
11282541|NCT02834663|OG000|Outcome|The Microaneurysm Turnover Baseline|The Retmarker software was used for automatic measurement and analysis of MA turnover at first visit.
11282542|NCT02834663|OG001|Outcome|The Microaneurysm Turnover Results|The Retmarker software was used for automatic measurement and analysis of MA turnover during monthly 6 months.
11282543|NCT02834663|OG000|Outcome|Perifoveal Non-perfusion Area Baseline|The perifoveal non-perfused areas in individual retinas were evaluated at first visit using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs
11282544|NCT02834663|OG001|Outcome|Perifoveal Non-perfusion Area Results|The perifoveal non-perfused areas in individual retinas were evaluated during monthly 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs
11282545|NCT02834663|OG000|Outcome|Safety Parameters Results|Complications and adverse events on patients were evaluated.
11282546|NCT02834663|EG000|Reported Event|Adverse Event|Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc) on patients were evaluated.
11282547|NCT02834806|BG000|Baseline|BioNIR Drug Eluting Stent System|"BioNIR Ridaforolimus eluting coronary stent system with modified delivery system~BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system"
11282548|NCT02834806|FG000|Participant Flow|BioNIR Drug Eluting Stent System|"BioNIR Ridaforolimus eluting coronary stent system with modified delivery system~BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system"
11282549|NCT02834806|OG000|Outcome|BioNIR Drug Eluting Stent System|"BioNIR Ridaforolimus eluting coronary stent system with modified delivery system~BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system"
11282550|NCT02834806|EG000|Reported Event|BioNIR Drug Eluting Stent System|"BioNIR Ridaforolimus eluting coronary stent system with modified delivery system~BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system"
11282551|NCT02834819|BG000|Baseline|Hypertonic Saline|"Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.~3% Nebulized Hypertonic Saline"
11282552|NCT02834819|BG001|Baseline|No Treatment|"Patients in the No treatment arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed."
11282553|NCT02834819|BG002|Baseline|Total|Total of all reporting groups
11282554|NCT02834819|FG000|Participant Flow|Hypertonic Saline|"Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.~3% Nebulized Hypertonic Saline"
11282555|NCT02834819|FG001|Participant Flow|No Treatment|"Patients in the No treatment arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed."
11282556|NCT02834819|OG000|Outcome|Hypertonic Saline|"Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.~3% Nebulized Hypertonic Saline"
11282557|NCT02834819|OG001|Outcome|No Treatment|"Patients in the No treatment arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed."
11282558|NCT02834819|EG000|Reported Event|Hypertonic Saline|"Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.~3% Nebulized Hypertonic Saline"
11282559|NCT02834819|EG001|Reported Event|No Treatment|"Patients in the No treatment arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed."
11282560|NCT02835092|BG000|Baseline|Self-directed Control|Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
11282561|NCT02835092|BG001|Baseline|Take Shape For Life Program|Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
11282562|NCT02835092|BG002|Baseline|Medifast Direct Program|Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
11282563|NCT02835092|BG003|Baseline|Total|Total of all reporting groups
11282564|NCT02835092|FG000|Participant Flow|Self-directed Control|Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
11282565|NCT02835092|FG001|Participant Flow|Take Shape For Life Program|Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
11282566|NCT02835092|FG002|Participant Flow|Medifast Direct Program|Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
11282567|NCT02835092|OG000|Outcome|Self-directed Control|Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
11282568|NCT02835092|OG001|Outcome|Take Shape For Life Program|Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
11282569|NCT02835092|OG002|Outcome|Medifast Direct Program|Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
11282570|NCT02835092|EG000|Reported Event|Self-directed Control|Self-directed Control: The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
11282571|NCT02835092|EG001|Reported Event|Take Shape For Life Program|Take Shape For Life Program: The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
11282572|NCT02835092|EG002|Reported Event|Medifast Direct Program|Medifast Direct Program: The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
11282573|NCT02835274|BG000|Baseline|Ring Mode Followed by Unrestricted Mode|"omni-directional stimulation followed by unrestricted Mode stimulation~BSC Deep Brain Stimulation System with Directional Lead"
11282574|NCT02835274|BG001|Baseline|Unrestricted Mode Followed by Ring Mode|"Unrestricted Mode stimulation followed by omni-directional stimulation~BSC Deep Brain Stimulation System with Directional Lead"
11282575|NCT02835274|BG002|Baseline|Total|Total of all reporting groups
11282576|NCT02835274|FG000|Participant Flow|Ring Mode Followed by Unrestricted Mode|"omni-directional stimulation followed by unrestricted Mode stimulation~BSC Deep Brain Stimulation System with Directional Lead"
11282577|NCT02835274|FG001|Participant Flow|Unrestricted Mode Followed by Ring Mode|"Unrestricted Mode stimulation followed by omni-directional stimulation~BSC Deep Brain Stimulation System with Directional Lead"
11282578|NCT02835274|OG000|Outcome|Ring Mode|BSC Deep Brain Stimulation System with Directional Lead
11282579|NCT02835274|OG001|Outcome|Unrestricted Mode|BSC Deep Brain Stimulation System with Directional Lead
11282580|NCT02835274|EG000|Reported Event|Ring Mode|"Ring Mode~BSC Deep Brain Stimulation System with Directional Lead"
11282581|NCT02835274|EG001|Reported Event|Unrestricted Mode|"Unrestricted mode~BSC Deep Brain Stimulation System with Directional Lead"
11282582|NCT02835339|BG000|Baseline|MgSO4 4g Load, 1g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 4g loading dose, 1g/hr infusion"
11282583|NCT02835339|BG001|Baseline|MgSO4 6g Load, 2g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 6g loading dose, 2g/hr infusion"
11282584|NCT02835339|BG002|Baseline|Total|Total of all reporting groups
11287146|NCT02898597|FG000|Participant Flow|Video|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11282585|NCT02835339|FG000|Participant Flow|MgSO4 4g Load, 1g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 4g loading dose, 1g/hr infusion"
11282586|NCT02835339|FG001|Participant Flow|MgSO4 6g Load, 2g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 6g loading dose, 2g/hr infusion"
11282587|NCT02835339|OG000|Outcome|MgSO4 4g Load, 1g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 4g loading dose, 1g/hr infusion"
11282588|NCT02835339|OG001|Outcome|MgSO4 6g Load, 2g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 6g loading dose, 2g/hr infusion"
11282589|NCT02835339|EG000|Reported Event|MgSO4 4g Load, 1g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 4g loading dose, 1g/hr infusion"
11282590|NCT02835339|EG001|Reported Event|MgSO4 6g Load, 2g/hr Infusion|"Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.~Magnesium sulfate 6g loading dose, 2g/hr infusion"
11282591|NCT02835495|BG000|Baseline|Lifestyle Weight Loss|"Behavioral: HELP Vets Intervention~Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator~HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week."
11282592|NCT02835495|BG001|Baseline|Enhanced Usual Care|"Behavioral: Individual Education Program~Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter~Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle."
11282593|NCT02835495|BG002|Baseline|Total|Total of all reporting groups
11282594|NCT02835495|FG000|Participant Flow|Lifestyle Weight Loss|"Behavioral: HELP Vets Intervention~Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator~HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week."
11282595|NCT02835495|FG001|Participant Flow|Enhanced Usual Care|"Behavioral: Individual Education Program~Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter~Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle."
11282596|NCT02835495|OG000|Outcome|Proportion of Eligible Participants of Total Screened|This reports the total number of participants who were screened and determined to be eligible for the study.
11282597|NCT02835495|OG001|Outcome|Proportion of Eligible Participants Who Were Randomized|This reports the total number of participants who were randomized of those eligible for participation.
11282598|NCT02835495|OG000|Outcome|Lifestyle Weight Loss|"Behavioral: HELP Vets Intervention~Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator~HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week."
11287147|NCT02898597|FG001|Participant Flow|Telephone|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11287148|NCT02898597|OG000|Outcome|Video|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11282599|NCT02835495|OG001|Outcome|Enhanced Usual Care|"Behavioral: Individual Education Program~Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter~Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle."
11282600|NCT02835495|EG000|Reported Event|Lifestyle Weight Loss|"Behavioral: HELP Vets Intervention~Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator~HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week."
11282601|NCT02835495|EG001|Reported Event|Enhanced Usual Care|"Behavioral: Individual Education Program~Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter~Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle."
11282602|NCT02835625|BG000|Baseline|Digital Breast Tomosynthesis|"Digital Breast Tomosynthesis + Synthetic Mammography (DBT)~The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis."
11282603|NCT02835625|BG001|Baseline|Digital Mammography|"The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis."
11282604|NCT02835625|BG002|Baseline|Total|Total of all reporting groups
11282605|NCT02835625|FG000|Participant Flow|Digital Breast Tomosynthesis|"Digital Breast Tomosynthesis + Synthetic Mammography (DBT)~The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis."
11282606|NCT02835625|FG001|Participant Flow|Digital Mammography|"The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis."
11282607|NCT02835625|OG000|Outcome|Digital Breast Tomosynthesis|"Digital Breast Tomosynthesis + Synthetic Mammography (DBT)~The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis."
11282608|NCT02835625|OG001|Outcome|Digital Mammography|"The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis."
11282609|NCT02835625|OG000|Outcome|Digital Breast Tomosynthesis Versus Digital Mammography|Comparing costs of procedure use and screening, recall and treatment costs estimated at the individual level for Digital Breast Tomosynthesis + Synthetic Mammography (DBT) versus Digital Mammography (DM).
11282610|NCT02835625|EG000|Reported Event|Digital Breast Tomosynthesis|"Digital Breast Tomosynthesis + Synthetic Mammography (DBT)~The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis."
11282611|NCT02835625|EG001|Reported Event|Digital Mammography|"The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.~Women selected for further assessment (positive screening exam) was recalled.~Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis."
11282612|NCT02835677|BG000|Baseline|Intervention|"Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation~Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management"
11282613|NCT02835677|FG000|Participant Flow|Intervention|"Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation~Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management"
10820424|NCT00057863|OG000|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
10820425|NCT00057863|EG000|Reported Event|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
10820426|NCT00057876|BG000|Baseline|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
11282614|NCT02835677|OG000|Outcome|Intervention|"Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation~Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management"
11282615|NCT02835677|EG000|Reported Event|Intervention|"Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation~Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management"
11282616|NCT02835820|BG000|Baseline|Ketogenic Diet Group|"Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants.~Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician."
11282617|NCT02835820|BG001|Baseline|Patient Choice Diet|Consumes regular diet/no diet restrictions
11282618|NCT02835820|BG002|Baseline|Total|Total of all reporting groups
11282619|NCT02835820|FG000|Participant Flow|Ketogenic Diet Group|"Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants.~Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician."
11282620|NCT02835820|FG001|Participant Flow|Participant Choice Diet|Control. Participants maintained normal dietary behaviors
11282621|NCT02835820|OG000|Outcome|Ketogenic Diet Group|"Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants.~Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician."
10970538|NCT00910910|OG000|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
11282622|NCT02835820|OG001|Outcome|Participant Choice Diet|Control. Participants maintained normal dietary behaviors
11282623|NCT02835820|EG000|Reported Event|Ketogenic Diet Group|"Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants.~Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician."
11282624|NCT02835820|EG001|Reported Event|Participant Choice Diet|Control. Participants maintained normal dietary behaviors
11282625|NCT02835846|BG000|Baseline|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11282626|NCT02835846|FG000|Participant Flow|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11282627|NCT02835846|OG000|Outcome|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11282628|NCT02835846|EG000|Reported Event|Estrogen Arm|"The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks~Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks."
11282629|NCT02836496|BG000|Baseline|Placebo|Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282630|NCT02836496|BG001|Baseline|Mepolizumab 300 mg SC|Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282631|NCT02836496|BG002|Baseline|Total|Total of all reporting groups
11282632|NCT02836496|FG000|Participant Flow|Placebo|Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282633|NCT02836496|FG001|Participant Flow|Mepolizumab 300 mg SC|Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282634|NCT02836496|OG000|Outcome|Placebo|Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282635|NCT02836496|OG001|Outcome|Mepolizumab 300 mg SC|Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282636|NCT02836496|EG000|Reported Event|Placebo|Participants were randomized to receive matching placebo SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
10970539|NCT00910910|OG001|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
11282637|NCT02836496|EG001|Reported Event|Mepolizumab 300 mg SC|Participants were randomized to receive 300 mg mepolizumab SC every 4 weeks during the 32-Week treatment period while continuing their HES therapy. The final dose was administered at Week 28 with the completion of study treatment period achieved in the next 4-weekly visit.
11282638|NCT02836613|BG000|Baseline|Galcanezumab Pre Filled Syringe (PFS)|Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
11282639|NCT02836613|BG001|Baseline|Galcanezumab Autoinjector|Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
11282640|NCT02836613|BG002|Baseline|Total|Total of all reporting groups
11282641|NCT02836613|FG000|Participant Flow|Galcanezumab Pre Filled Syringe (PFS)|Single dose of 240 mg galcanezumab administered subcutaneously (SC) by manual prefilled syringe.
11282642|NCT02836613|FG001|Participant Flow|Galcanezumab Autoinjector|Single dose of 240 mg galcanezumab administered SC by autoinjector.
11282643|NCT02836613|OG000|Outcome|Galcanezumab Pre Filled Syringe (PFS)|Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
11282644|NCT02836613|OG001|Outcome|Galcanezumab Autoinjector|Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
11282645|NCT02836613|EG000|Reported Event|Galcanezumab Pre Filled Syringe (PFS)|Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
11282646|NCT02836613|EG001|Reported Event|Galcanezumab Autoinjector|Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
11282647|NCT02836652|BG000|Baseline|Placebo|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)"
11282648|NCT02836652|BG001|Baseline|Aspirin|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)~acetylsalicylic acid (ASA) therapy: (81mg/day)"
11282649|NCT02836652|BG002|Baseline|Total|Total of all reporting groups
11282650|NCT02836652|FG000|Participant Flow|Placebo|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)"
11282651|NCT02836652|FG001|Participant Flow|Aspirin|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)~acetylsalicylic acid (ASA) therapy: (81mg/day)"
11282652|NCT02836652|OG000|Outcome|Placebo|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)"
11282653|NCT02836652|OG001|Outcome|Aspirin|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)~acetylsalicylic acid (ASA) therapy: (81mg/day)"
11282654|NCT02836652|EG000|Reported Event|Placebo|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)"
11282655|NCT02836652|EG001|Reported Event|Aspirin|"Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant~HeartMate II (HMII): Left Ventricular Assist Device~Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care)~acetylsalicylic acid (ASA) therapy: (81mg/day)"
11282656|NCT02836769|BG000|Baseline|Rehabilitation Consult (RC)|"Pilot testing: single group pre-post design~Rehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary."
11282657|NCT02836769|FG000|Participant Flow|Rehabilitation Consult (RC)|"Pilot testing: single group pre-post design~Rehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary."
11282658|NCT02836769|OG000|Outcome|Rehabilitation Consult (RC)|"Pilot testing: single group pre-post design~Rehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary."
11287149|NCT02898597|OG001|Outcome|Telephone|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11287150|NCT02898597|EG000|Reported Event|Video|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11282659|NCT02836769|EG000|Reported Event|Rehabilitation Consult (RC)|"Pilot testing: single group pre-post design~Rehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary."
11282660|NCT02836873|BG000|Baseline|Bexagliflozin 20 mg|Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
11282661|NCT02836873|BG001|Baseline|Placebo|Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
11282662|NCT02836873|BG002|Baseline|Total|Total of all reporting groups
11282663|NCT02836873|FG000|Participant Flow|Bexagliflozin 20 mg|Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
11282664|NCT02836873|FG001|Participant Flow|Placebo|Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
11282665|NCT02836873|OG000|Outcome|Bexagliflozin 20 mg|Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
11282666|NCT02836873|OG001|Outcome|Placebo|Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
11282667|NCT02836873|EG000|Reported Event|Bexagliflozin 20 mg|Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
11282668|NCT02836873|EG001|Reported Event|Placebo|Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
11282669|NCT02836990|BG000|Baseline|Prevena|"Prevena Incision Management System for vascular surgical groin wounds~Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections"
11282670|NCT02836990|BG001|Baseline|Dermabond|"Dermabond for vascular surgical groin wounds~Dermabond: A surgical skin adhesive used to prevent surgical wound infections"
11282671|NCT02836990|BG002|Baseline|Total|Total of all reporting groups
11282672|NCT02836990|FG000|Participant Flow|Prevena|"Prevena Incision Management System for vascular surgical groin wounds~Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections"
11282673|NCT02836990|FG001|Participant Flow|Dermabond|"Dermabond for vascular surgical groin wounds~Dermabond: A surgical skin adhesive used to prevent surgical wound infections"
11282674|NCT02836990|OG000|Outcome|Prevena|"Prevena Incision Management System for vascular surgical groin wounds~Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections"
11282675|NCT02836990|OG001|Outcome|Dermabond|"Dermabond for vascular surgical groin wounds~Dermabond: A surgical skin adhesive used to prevent surgical wound infections"
11282676|NCT02836990|OG000|Outcome|Preveena|"Outcome measures for cost were not calculated as initially planned as the primary outcome did not demonstrate any superiority with the Wound vacuum device, which is more expensive than the dermabond. Had there been improved clinical outcomes, financial benefit would have been assessed by comparing costs of infection vs device cost.~As the primary outcome was not improved, this outcome was no longer necessary."
11282677|NCT02836990|OG001|Outcome|Dermabond|Assessment not performed financially as Dermabond is less expensive than Preveena, and preveena did not achieve clinical superiority invalidating the need for this analysis to determine whether Preveena was more cost effective for the system.
11282678|NCT02836990|EG000|Reported Event|Prevena|"Prevena Incision Management System for vascular surgical groin wounds~Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections"
11282679|NCT02836990|EG001|Reported Event|Dermabond|"Dermabond for vascular surgical groin wounds~Dermabond: A surgical skin adhesive used to prevent surgical wound infections"
11282680|NCT02837237|BG000|Baseline|KBP-5074|"Single oral dose~KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.~In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session."
11282681|NCT02837237|FG000|Participant Flow|KBP-5074|"Single oral dose~KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.~In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session."
11282682|NCT02837237|OG000|Outcome|KBP-5074|"Single oral dose~KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.~In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session."
11282683|NCT02837237|EG000|Reported Event|KBP-5074|"Single oral dose~KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.~In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session."
11282684|NCT02837328|BG000|Baseline|Oral Magnesium Supplement|"400 mg Magnesium Citrate 1x daily for 12 weeks~Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282685|NCT02837328|BG001|Baseline|Placebo|"Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks~Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282686|NCT02837328|BG002|Baseline|Total|Total of all reporting groups
11282687|NCT02837328|FG000|Participant Flow|Oral Magnesium Supplement|"400 mg Magnesium Citrate 1x daily for 12 weeks~Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282688|NCT02837328|FG001|Participant Flow|Placebo|"Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks~Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282689|NCT02837328|OG000|Outcome|Oral Magnesium Supplement|"400 mg Magnesium Citrate 1x daily for 12 weeks~Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282690|NCT02837328|OG001|Outcome|Placebo|"Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks~Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282691|NCT02837328|EG000|Reported Event|Oral Magnesium Supplement|"400 mg Magnesium Citrate 1x daily for 12 weeks~Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282692|NCT02837328|EG001|Reported Event|Placebo|"Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks~Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks"
11282693|NCT02837731|BG000|Baseline|Treatment Starling SV Monitor|A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of < 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
11282694|NCT02837731|BG001|Baseline|Usual Care|No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
11282695|NCT02837731|BG002|Baseline|Total|Total of all reporting groups
11282696|NCT02837731|FG000|Participant Flow|Treatment Starling SV Monitor|During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.
11282697|NCT02837731|FG001|Participant Flow|Usual Care|During Allocation phase, randomization was a 2:1 allocation of SV-guided to usual care. Subjects that didn't complete Follow-up phase are those that (1) show data that indicates unacceptable bias in the measurements, (2) data collection is interrupted prior to 72 hour data collection period of ICU stay, or (3) severe agitation and/or cardiopulmonary resuscitations resulted in poor quality data. Subjects completed follow-up were included in the Analysis.
11282698|NCT02837731|OG000|Outcome|Treatment Starling SV Monitor|A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of < 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
11282699|NCT02837731|OG001|Outcome|Usual Care|No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
11282700|NCT02837731|EG000|Reported Event|Treatment Starling SV Monitor|A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of < 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
11282701|NCT02837731|EG001|Reported Event|Usual Care|No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
11282702|NCT02837744|BG000|Baseline|Axiostat®|"Size: 3.5 cm X 3.5 cm~Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier."
11282703|NCT02837744|FG000|Participant Flow|Axiostat®|"Size: 3.5 cm X 3.5 cm~Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier."
11282704|NCT02837744|OG000|Outcome|Axiostat®|"Size: 3.5 cm X 3.5 cm~Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier."
11282705|NCT02837744|EG000|Reported Event|Axiostat®|"Size: 3.5 cm X 3.5 cm~Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier."
11282706|NCT02837913|BG000|Baseline|Underbody Warmer on|"Underbody warmer will be underneath the patient and turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282707|NCT02837913|BG001|Baseline|Underbody Warmer Off|"Underbody warmer will be underneath the patient but not turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282708|NCT02837913|BG002|Baseline|Total|Total of all reporting groups
11282709|NCT02837913|FG000|Participant Flow|Underbody Warmer on|"Underbody warmer will be underneath the patient and turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282710|NCT02837913|FG001|Participant Flow|Underbody Warmer Off|"Underbody warmer will be underneath the patient but not turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282711|NCT02837913|OG000|Outcome|Underbody Warmer on|"Underbody warmer will be underneath the patient and turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282712|NCT02837913|OG001|Outcome|Underbody Warmer Off|"Underbody warmer will be underneath the patient but not turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282713|NCT02837913|EG000|Reported Event|Underbody Warmer on|"Underbody warmer will be underneath the patient and turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282714|NCT02837913|EG001|Reported Event|Underbody Warmer Off|"Underbody warmer will be underneath the patient but not turned on.~VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively"
11282715|NCT02837952|BG000|Baseline|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282716|NCT02837952|BG001|Baseline|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282717|NCT02837952|BG002|Baseline|Total|Total of all reporting groups
11282718|NCT02837952|FG000|Participant Flow|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282719|NCT02837952|FG001|Participant Flow|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282720|NCT02837952|OG000|Outcome|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282721|NCT02837952|OG001|Outcome|Ibuprofen 250 mg / Acetaminophen 500|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282722|NCT02837952|EG000|Reported Event|Placebo|Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282723|NCT02837952|EG001|Reported Event|Ibuprofen 250 mg / Acetaminophen 500 mg|Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
11282724|NCT02838017|BG000|Baseline|Tissue Adhesive|"Tissue Adhesive will be placed over subcuticular suture closure.~Tissue Adhesive"
11282725|NCT02838017|BG001|Baseline|Steri-Strips|"Sterile strips will be placed over subcuticular suture closure.~Sterile strips"
11282726|NCT02838017|BG002|Baseline|Total|Total of all reporting groups
11092400|NCT01539642|BG000|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11282727|NCT02838017|FG000|Participant Flow|Tissue Adhesive|"Tissue Adhesive will be placed over subcuticular suture closure.~Tissue Adhesive"
11282728|NCT02838017|FG001|Participant Flow|Sterile Strips|"Sterile strips will be placed over subcuticular suture closure.~Sterile strips"
11282729|NCT02838017|OG000|Outcome|Tissue Adhesive|"Tissue Adhesive will be placed over subcuticular suture closure.~Tissue Adhesive"
11282730|NCT02838017|OG001|Outcome|Sterile Strips|"Sterile strips will be placed over subcuticular suture closure.~Sterile strips"
11092401|NCT01539642|BG001|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11092402|NCT01539642|BG002|Baseline|Total|Total of all reporting groups
11282731|NCT02838017|EG000|Reported Event|Tissue Adhesive|"Tissue Adhesive will be placed over subcuticular suture closure.~Tissue Adhesive"
11282732|NCT02838017|EG001|Reported Event|Sterile Strips|"Sterile strips will be placed over subcuticular suture closure.~Sterile strips"
11282733|NCT02838134|BG000|Baseline|Group A: Deep Neuromuscular Blockade|"An extra bolus of rocuronium after intubation followed by infusion~Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2."
11282734|NCT02838134|BG001|Baseline|Group B: Moderate Neuromuscular Blockade|"Moderate neuromuscular Blockade No additional rocuronium after intubation.~No additional Rocuronium: No additional rocuronium is administered after tracheal intubation."
11282735|NCT02838134|BG002|Baseline|Total|Total of all reporting groups
11287151|NCT02898597|EG001|Reported Event|Telephone|"Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)~Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling"
11282736|NCT02838134|FG000|Participant Flow|Group A: Deep Neuromuscular Blockade|"An extra bolus of rocuronium after intubation followed by infusion~Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2."
11282737|NCT02838134|FG001|Participant Flow|Group B: Moderate Neuromuscular Blockade|"Moderate neuromuscular Blockade No additional rocuronium after intubation.~No additional Rocuronium: No additional rocuronium is administered after tracheal intubation."
11282738|NCT02838134|OG000|Outcome|Group A: Deep Neuromuscular Blockade|"An extra bolus of rocuronium after intubation followed by infusion~Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2."
11282739|NCT02838134|OG001|Outcome|Group B: Moderate Neuromuscular Blockade|"Moderate neuromuscular Blockade No additional rocuronium after intubation.~No additional Rocuronium: No additional rocuronium is administered after tracheal intubation."
11282740|NCT02838134|EG000|Reported Event|Group A: Deep Neuromuscular Blockade|"An extra bolus of rocuronium after intubation followed by infusion~Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2."
11282741|NCT02838134|EG001|Reported Event|Group B: Moderate Neuromuscular Blockade|"Moderate neuromuscular Blockade No additional rocuronium after intubation.~No additional Rocuronium: No additional rocuronium is administered after tracheal intubation."
11282742|NCT02838407|BG000|Baseline|Total Group|All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
11282743|NCT02838407|FG000|Participant Flow|Total Group|All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
11282744|NCT02838407|OG000|Outcome|Total Group|All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
11282745|NCT02838407|EG000|Reported Event|Total Group|All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
11282746|NCT02838420|BG000|Baseline|Alectinib|Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
11282747|NCT02838420|BG001|Baseline|Crizotinib|Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
11282748|NCT02838420|BG002|Baseline|Total|Total of all reporting groups
11282749|NCT02838420|FG000|Participant Flow|Alectinib|Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
11282750|NCT02838420|FG001|Participant Flow|Crizotinib|Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
11282751|NCT02838420|OG000|Outcome|Alectinib|Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
11282752|NCT02838420|OG001|Outcome|Crizotinib|Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
11282753|NCT02838420|EG000|Reported Event|Alectinib|Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
11282754|NCT02838420|EG001|Reported Event|Crizotinib|Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
11282755|NCT02838628|BG000|Baseline|KX2-391 50 mg (Days 1 to 5)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 5 consecutive days.
11282756|NCT02838628|BG001|Baseline|KX2-391 50 mg (Days 1 to 3)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
11282757|NCT02838628|BG002|Baseline|Total|Total of all reporting groups
11282758|NCT02838628|FG000|Participant Flow|KX2-391 50 mg (Days 1 to 5)|Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days.
11282759|NCT02838628|FG001|Participant Flow|KX2-391 50 mg (Days 1 to 3)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
11282760|NCT02838628|OG000|Outcome|KX2-391 50 mg (Days 1 to 5)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 5 consecutive days.
11282761|NCT02838628|OG001|Outcome|KX2-391 50 mg (Days 1 to 3)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
11282762|NCT02838628|OG000|Outcome|KX2-391 50 mg (Days 1 to 5)|Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days.
11282763|NCT02838628|EG000|Reported Event|KX2-391 50 mg (Days 1 to 5)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 5 consecutive days.
11282764|NCT02838628|EG001|Reported Event|KX2-391 50 mg (Days 1 to 3)|Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
11282765|NCT02838901|BG000|Baseline|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
11282766|NCT02838901|BG001|Baseline|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
11282767|NCT02838901|BG002|Baseline|Total|Total of all reporting groups
11282768|NCT02838901|FG000|Participant Flow|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.~Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow."
11282769|NCT02838901|FG001|Participant Flow|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.~Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b"
11282770|NCT02838901|OG000|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
11282771|NCT02838901|OG001|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
11282772|NCT02838901|OG000|Outcome|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.~Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow."
11282773|NCT02838901|OG001|Outcome|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.~Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.~Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.~Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b"
11282774|NCT02838901|EG000|Reported Event|Beet It Beetroot Juice|"70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.~Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle"
11282775|NCT02838901|EG001|Reported Event|Beet It Beetroot Juice Placebo|"70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.~Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice."
11282776|NCT02839200|BG000|Baseline|ACT-541468 5 mg|"Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282777|NCT02839200|BG001|Baseline|ACT-541468 10 mg|"Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11092403|NCT01539642|FG000|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11092404|NCT01539642|FG001|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11282778|NCT02839200|BG002|Baseline|ACT-541468 25 mg|"Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282779|NCT02839200|BG003|Baseline|ACT-541468 50 mg|"Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg"
11282780|NCT02839200|BG004|Baseline|Zolpidem|"Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks~Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg~Placebo 2: Placebo capsules matching over-encapsulated zolpidem"
11282781|NCT02839200|BG005|Baseline|Placebo|"Each subject received two placebo capsules, once daily in the evening for 4 weeks~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282782|NCT02839200|BG006|Baseline|Total|Total of all reporting groups
11282783|NCT02839200|FG000|Participant Flow|ACT-541468 5 mg|"Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282784|NCT02839200|FG001|Participant Flow|ACT-541468 10 mg|"Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282785|NCT02839200|FG002|Participant Flow|ACT-541468 25 mg|"Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282786|NCT02839200|FG003|Participant Flow|ACT-541468 50 mg|"Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg"
11282787|NCT02839200|FG004|Participant Flow|Zolpidem|"Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks~Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg~Placebo 2: Placebo capsules matching over-encapsulated zolpidem"
11282788|NCT02839200|FG005|Participant Flow|Placebo|"Each subject received two placebo capsules, once daily in the evening for 4 weeks~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282789|NCT02839200|OG000|Outcome|ACT-541468 5 mg|"Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282790|NCT02839200|OG001|Outcome|ACT-541468 10 mg|"Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282791|NCT02839200|OG002|Outcome|ACT-541468 25 mg|"Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282792|NCT02839200|OG003|Outcome|ACT-541468 50 mg|"Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg"
11282793|NCT02839200|OG004|Outcome|Zolpidem|"Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks~Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg~Placebo 2: Placebo capsules matching over-encapsulated zolpidem"
11282794|NCT02839200|OG005|Outcome|Placebo|"Each subject received two placebo capsules, once daily in the evening for 4 weeks~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282795|NCT02839200|EG000|Reported Event|ACT-541468 5 mg|"Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282796|NCT02839200|EG001|Reported Event|ACT-541468 10 mg|"Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks~ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282797|NCT02839200|EG002|Reported Event|ACT-541468 25 mg|"Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282798|NCT02839200|EG003|Reported Event|ACT-541468 50 mg|"Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks~ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg"
11282799|NCT02839200|EG004|Reported Event|Zolpidem|"Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks~Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg~Placebo 2: Placebo capsules matching over-encapsulated zolpidem"
11282800|NCT02839200|EG005|Reported Event|Placebo|"Each subject received two placebo capsules, once daily in the evening for 4 weeks~Placebo 1: Placebo capsules matching ACT-541468 capsules"
11282801|NCT02839330|BG000|Baseline|Group A: aH5N1c Lot #1|aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
11282802|NCT02839330|BG001|Baseline|Group B: aH5N1c Lot #2|aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
11282803|NCT02839330|BG002|Baseline|Group C: aH5N1c Lot #3|aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
11282804|NCT02839330|BG003|Baseline|Group D: Placebo|Placebo; receive 2 doses (on Day 1 and Day 22)
11282805|NCT02839330|BG004|Baseline|Total|Total of all reporting groups
11282806|NCT02839330|FG000|Participant Flow|Group A: aH5N1c Lot #1|aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
11282807|NCT02839330|FG001|Participant Flow|Group B: aH5N1c Lot #2|aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
11282808|NCT02839330|FG002|Participant Flow|Group C: aH5N1c Lot #3|aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
11282809|NCT02839330|FG003|Participant Flow|Group D: Placebo|Placebo; receive 2 doses (on Day 1 and Day 22)
11282810|NCT02839330|OG000|Outcome|Group A: aH5N1c Lot #1|aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
11282811|NCT02839330|OG001|Outcome|Group B: aH5N1c Lot #2|aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
11282812|NCT02839330|OG002|Outcome|Group C: aH5N1c Lot #3|aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
11282813|NCT02839330|OG000|Outcome|aH5N1c|aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
11282814|NCT02839330|OG001|Outcome|Placebo|Placebo; receive 2 doses (on Day 1 and Day 22)
11282815|NCT02839330|OG000|Outcome|aH5N1c|aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
11282816|NCT02839330|OG001|Outcome|Placebo|Placebo, received 2 doses on Day 1 and Day 22
11282817|NCT02839330|EG000|Reported Event|aH5N1c|aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
11282818|NCT02839330|EG001|Reported Event|Placebo|Placebo; receive 2 doses (on Day 1 and Day 22)
11282819|NCT02839681|BG000|Baseline|1/Safety Run-in Arm|"Subjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study~Anetumab Ravtansine: Administered intravenously (IV) every 3 weeks~Blood test: Research blood test for eligibility"
11282820|NCT02839681|FG000|Participant Flow|1/Safety Run-in Arm|"Subjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study~Anetumab Ravtansine: Administered intravenously (IV) every 3 weeks~Blood test: Research blood test for eligibility"
11282821|NCT02839681|OG000|Outcome|1/Safety Run-in Arm|"Subjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study~Anetumab Ravtansine: Administered intravenously (IV) every 3 weeks~Blood test: Research blood test for eligibility"
11282822|NCT02839681|EG000|Reported Event|1/Safety Run-in Arm|"Subjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study~Anetumab Ravtansine: Administered intravenously (IV) every 3 weeks~Blood test: Research blood test for eligibility"
11282823|NCT02839746|BG000|Baseline|Total|Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily dose of Pradaxa® 110 mg or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.
11282824|NCT02839746|FG000|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily oral dose of Pradaxa® 110 milligram (mg) or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.
11282825|NCT02839746|OG000|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily oral dose of Pradaxa® 110 milligram (mg) or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.
11282826|NCT02839746|EG000|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily oral dose of Pradaxa® 110 milligram (mg) or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.
11282827|NCT02839772|BG000|Baseline|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282828|NCT02839772|BG001|Baseline|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282829|NCT02839772|BG002|Baseline|Total|Total of all reporting groups
11282830|NCT02839772|FG000|Participant Flow|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282831|NCT02839772|FG001|Participant Flow|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282832|NCT02839772|OG000|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282833|NCT02839772|OG001|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282834|NCT02839772|OG000|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282835|NCT02839772|OG001|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282836|NCT02839772|OG000|Outcome|Stage of Podoconiosis 1st Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
11282837|NCT02839772|OG001|Outcome|Stage of Podoconiosis 4th Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
11282838|NCT02839772|OG000|Outcome|Total Number of Trophic Skin Changes at Baseline|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.
11282839|NCT02839772|OG001|Outcome|Total Number of Trophic Skin Changes at 4th Visit|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
11282840|NCT02839772|OG000|Outcome|Participants With Bad Odour From Legs/Feet at Baseline|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
11282841|NCT02839772|OG001|Outcome|Participants With Bad Odour From Legs/Feet at 4th Visit|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
11282842|NCT02839772|OG000|Outcome|Number of Wounds at Baseline|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.
11282843|NCT02839772|OG001|Outcome|Number of Wounds 4th Visit|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
11282844|NCT02839772|OG000|Outcome|Number of Days Work Days Lost by All Participants Baseline|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282845|NCT02839772|OG001|Outcome|Number of Days Lost by All Participants at 4th Visit|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282846|NCT02839772|OG000|Outcome|Correlation Between Number of Wounds and Days Lost Due to ADL|Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
11282847|NCT02839772|OG001|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
11282848|NCT02839772|EG000|Reported Event|Control Group|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282849|NCT02839772|EG001|Reported Event|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
11282850|NCT02839798|BG000|Baseline|sTMS Active|"Treatment with the NEST Device~NEST (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression."
11282851|NCT02839798|FG000|Participant Flow|sTMS Active|"Treatment with the NEST Device~NEST (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression."
11282852|NCT02839798|OG000|Outcome|sTMS Active|"Treatment with the NEST Device~NEST (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression."
11282853|NCT02839798|EG000|Reported Event|ACTIVE sTMS|"Active Open Label Treatment with the NEST Device~NEST (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression."
11282854|NCT02839876|BG000|Baseline|Intravenous Acetaminophen|"Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.~Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area."
11282855|NCT02839876|BG001|Baseline|Oral Acetaminophen|"Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.~Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area."
11282856|NCT02839876|BG002|Baseline|Total|Total of all reporting groups
11282857|NCT02839876|FG000|Participant Flow|Intravenous Acetaminophen|"Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.~Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area."
11282858|NCT02839876|FG001|Participant Flow|Oral Acetaminophen|"Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.~Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area."
11282859|NCT02839876|OG000|Outcome|Intravenous Acetaminophen|"Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.~Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area."
11282860|NCT02839876|OG001|Outcome|Oral Acetaminophen|"Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.~Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area."
11282861|NCT02839876|EG000|Reported Event|Intravenous Acetaminophen|"Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.~Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area."
11282862|NCT02839876|EG001|Reported Event|Oral Acetaminophen|"Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.~Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area."
11282863|NCT02839889|BG000|Baseline|Placebo|"Placebo once daily for two weeks~Placebo: Placebo once daily for two weeks, followed by two week open-label period"
11282864|NCT02839889|BG001|Baseline|Naloxegol|"Naloxegol 25mg tablets once daily for two weeks~Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period"
11282865|NCT02839889|BG002|Baseline|Total|Total of all reporting groups
11282866|NCT02839889|FG000|Participant Flow|Placebo|"Placebo once daily for two weeks~Placebo: Placebo once daily for two weeks, followed by two week open-label period"
11282867|NCT02839889|FG001|Participant Flow|Naloxegol|"Naloxegol 25mg tablets once daily for two weeks~Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period"
11282868|NCT02839889|OG000|Outcome|Placebo|"Placebo once daily for two weeks~Placebo: Placebo once daily for two weeks, followed by two week open-label period"
11282869|NCT02839889|OG001|Outcome|Naloxegol|"Naloxegol 25mg tablets once daily for two weeks~Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period"
11282870|NCT02839889|EG000|Reported Event|Placebo|"Placebo once daily for two weeks~Placebo: Placebo once daily for two weeks, followed by two week open-label period"
11282871|NCT02839889|EG001|Reported Event|Naloxegol|"Naloxegol 25mg tablets once daily for two weeks~Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period"
11282872|NCT02839902|BG000|Baseline|TAK-085 4 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
11282873|NCT02839902|BG001|Baseline|Control Group|Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
11282874|NCT02839902|BG002|Baseline|Total|Total of all reporting groups
11282875|NCT02839902|FG000|Participant Flow|TAK-085 4 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
11282876|NCT02839902|FG001|Participant Flow|Control Group|Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
11282877|NCT02839902|OG000|Outcome|TAK-085 4 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
11282878|NCT02839902|OG001|Outcome|Control Group|Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
11282879|NCT02839902|EG000|Reported Event|TAK-085 4 g|A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
11282880|NCT02839902|EG001|Reported Event|Control Group|Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
11282881|NCT02840097|BG000|Baseline|Tranexamic Acid Dose A|"Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282882|NCT02840097|BG001|Baseline|Tranexamic Acid Dose B|"Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282883|NCT02840097|BG002|Baseline|Placebo|"Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.~Placebo: Normal saline is provided to participants if randomized to this treatment arm."
11282884|NCT02840097|BG003|Baseline|Total|Total of all reporting groups
11282885|NCT02840097|FG000|Participant Flow|Tranexamic Acid Dose A|"Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282886|NCT02840097|FG001|Participant Flow|Tranexamic Acid Dose B|"Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282887|NCT02840097|FG002|Participant Flow|Placebo|"Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.~Placebo: Normal saline is provided to participants if randomized to this treatment arm."
11282888|NCT02840097|OG000|Outcome|Tranexamic Acid Dose A|Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.
11282889|NCT02840097|OG001|Outcome|Tranexamic Acid Dose B|Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.
11282890|NCT02840097|OG002|Outcome|Placebo|Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.
11282891|NCT02840097|OG000|Outcome|Tranexamic Acid Dose A|"Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282892|NCT02840097|OG001|Outcome|Tranexamic Acid Dose B|"Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282893|NCT02840097|OG002|Outcome|Placebo|"Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.~Placebo: Normal saline is provided to participants if randomized to this treatment arm."
11282894|NCT02840097|EG000|Reported Event|Tranexamic Acid Dose A|"Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282895|NCT02840097|EG001|Reported Event|Tranexamic Acid Dose B|"Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.~Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to."
11282896|NCT02840097|EG002|Reported Event|Placebo|"Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.~Placebo: Normal saline is provided to participants if randomized to this treatment arm."
11282897|NCT02840253|BG000|Baseline|NIRS|"Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.~NIRS"
11282898|NCT02840253|FG000|Participant Flow|NIRS|"Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.~NIRS"
11282899|NCT02840253|OG000|Outcome|NIRS|"Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.~NIRS"
11282900|NCT02840253|EG000|Reported Event|NIRS|"Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.~NIRS"
11282901|NCT02840461|BG000|Baseline|Ivermectin Cream, 1%|"Test product, manufactured by Actavis Laboratories UT, Inc.~Ivermectin Cream, 1%"
11282902|NCT02840461|BG001|Baseline|SoolantraTM (Ivermectin) Cream, 1%|"Reference product, manufactured by Galderma Laboratories, L.P.~Ivermectin Cream, 1%"
11282903|NCT02840461|BG002|Baseline|Placebo/Vehicle Cream|"Placebo, manufactured by Actavis Laboratories UT, Inc.~Placebo/Vehicle cream"
11282904|NCT02840461|BG003|Baseline|Total|Total of all reporting groups
11282905|NCT02840461|FG000|Participant Flow|Ivermectin Cream, 1%|"Test product, manufactured by Actavis Laboratories UT, Inc.~Ivermectin Cream, 1%"
11282906|NCT02840461|FG001|Participant Flow|SoolantraTM (Ivermectin) Cream, 1%|"Reference product, manufactured by Galderma Laboratories, L.P.~Ivermectin Cream, 1%"
11282907|NCT02840461|FG002|Participant Flow|Placebo/Vehicle Cream|"Placebo, manufactured by Actavis Laboratories UT, Inc.~Placebo/Vehicle cream"
11282908|NCT02840461|OG000|Outcome|Ivermectin Cream, 1%|"Test product, manufactured by Actavis Laboratories UT, Inc.~Ivermectin Cream, 1%"
11282909|NCT02840461|OG001|Outcome|SoolantraTM (Ivermectin) Cream, 1%|"Reference product, manufactured by Galderma Laboratories, L.P.~Ivermectin Cream, 1%"
11282910|NCT02840461|OG002|Outcome|Vehicle Cream|Placebo cream (manufactured by Actavis Laboratories UT, Inc.)
11282911|NCT02840461|OG002|Outcome|Vehicle Cream|Placebo Cream: manufactured by Actavis Laboratories UT., Inc.
11282912|NCT02840461|EG000|Reported Event|Ivermectin Cream, 1%|"Test product, manufactured by Actavis Laboratories UT, Inc.~Ivermectin Cream, 1%"
11282913|NCT02840461|EG001|Reported Event|SoolantraTM (Ivermectin) Cream, 1%|"Reference product, manufactured by Galderma Laboratories, L.P.~Ivermectin Cream, 1%"
11282914|NCT02840461|EG002|Reported Event|Placebo/Vehicle Cream|"Placebo, manufactured by Actavis Laboratories UT, Inc.~Placebo/Vehicle cream"
11282915|NCT02840474|BG000|Baseline|Part A: VRC01LS (40 mg/kg)|"VRC-HIVMAB080-00-AB (VRC01LS) - (40 mg/kg) - administered intravenously (IV) at Day 0~VRC-HIVMAB080-00-AB: VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282916|NCT02840474|BG001|Baseline|Part B: VRC07-523LS (40 mg/kg)|"VRC-HIVMAB075-00-AB (VRC07-523LS) - (40 mg/kg) - administered IV at Day 0~VRC-HIVMAB075-00-AB: VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282917|NCT02840474|BG002|Baseline|Total|Total of all reporting groups
11282918|NCT02840474|FG000|Participant Flow|Part A: VRC01LS (40 mg/kg)|"VRC-HIVMAB080-00-AB (VRC01LS) - (40 mg/kg) - administered intravenously (IV) at Day 0~VRC-HIVMAB080-00-AB: VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282919|NCT02840474|FG001|Participant Flow|Part B: VRC07-523LS (40 mg/kg)|"VRC-HIVMAB075-00-AB (VRC07-523LS) - (40 mg/kg) - administered IV at Day 0~VRC-HIVMAB075-00-AB: VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282920|NCT02840474|OG000|Outcome|Part A: VRC01LS (40 mg/kg)|"VRC-HIVMAB080-00-AB (VRC01LS) - (40 mg/kg) - administered intravenously (IV) at Day 0~VRC-HIVMAB080-00-AB: VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282921|NCT02840474|OG001|Outcome|Part B: VRC07-523LS (40 mg/kg)|"VRC-HIVMAB075-00-AB (VRC07-523LS) - (40 mg/kg) - administered IV at Day 0~VRC-HIVMAB075-00-AB: VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282922|NCT02840474|EG000|Reported Event|Part A: VRC01LS (40 mg/kg)|"VRC-HIVMAB080-00-AB (VRC01LS) - (40 mg/kg) - administered intravenously (IV) at Day 0~VRC-HIVMAB080-00-AB: VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282923|NCT02840474|EG001|Reported Event|Part B: VRC07-523LS (40 mg/kg)|"VRC-HIVMAB075-00-AB (VRC07-523LS) - (40 mg/kg) - administered IV at Day 0~VRC-HIVMAB075-00-AB: VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1."
11282924|NCT02840721|BG000|Baseline|PF-06480605 500 mg IV|Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
11282925|NCT02840721|FG000|Participant Flow|PF-06480605 500 mg IV|Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
11282926|NCT02840721|OG000|Outcome|PF-06480605 500 mg IV|Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
11282927|NCT02840721|EG000|Reported Event|PF-06480605 500 mg IV|Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
11282928|NCT02840916|BG000|Baseline|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
11282929|NCT02840916|BG001|Baseline|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
11282930|NCT02840916|BG002|Baseline|Total|Total of all reporting groups
11282931|NCT02840916|FG000|Participant Flow|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
11282932|NCT02840916|FG001|Participant Flow|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
11282933|NCT02840916|OG000|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
11282934|NCT02840916|OG001|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
11282935|NCT02840916|EG000|Reported Event|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
11282936|NCT02840916|EG001|Reported Event|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
11282937|NCT02841033|BG000|Baseline|Daratumumab|"Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.~Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed."
11282938|NCT02841033|FG000|Participant Flow|Daratumumab|"Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.~Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed."
11282939|NCT02841033|OG000|Outcome|Daratumumab|"Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.~Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed."
11282940|NCT02841033|EG000|Reported Event|Daratumumab|"Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.~Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed."
11282941|NCT02841046|BG000|Baseline|Group Cardiac Index|"the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .~cardiac index: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment."
11282942|NCT02841046|BG001|Baseline|Group Stroke Volume Variation|"the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .~Stroke Volume Variation: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment."
11282943|NCT02841046|BG002|Baseline|Total|Total of all reporting groups
11282944|NCT02841046|FG000|Participant Flow|Group Cardiac Index|"the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .~cardiac index: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment."
11282945|NCT02841046|FG001|Participant Flow|Group Stroke Volume Variation|"the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .~Stroke Volume Variation: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment."
11282946|NCT02841046|OG000|Outcome|Group Cardiac Index|"the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .~cardiac index: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment."
11282947|NCT02841046|OG001|Outcome|Group Stroke Volume Variation|"the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .~Stroke Volume Variation: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment."
11282948|NCT02841046|EG000|Reported Event|Group Cardiac Index|"the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .~cardiac index: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment."
11282949|NCT02841046|EG001|Reported Event|Group Stroke Volume Variation|"the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .~Stroke Volume Variation: group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment."
11282950|NCT02841189|BG000|Baseline|Participants|Participant details
11282951|NCT02841189|FG000|Participant Flow|Ease of Endotracheal Tube Passage|"Intubations rated as easy and answers collected yes or no. s"
11282952|NCT02841189|OG000|Outcome|Ease of Endotracheal Tube Passage|"Intubations rated as easy with data score of 1 or 2"
11282953|NCT02841189|EG000|Reported Event|Adverse Event Participants|Adverse event affecting participant details
11282954|NCT02841241|BG000|Baseline|Esmolol|"Esmolol infusion, started without bolus, with slow upward titration to a maximum infusion rate is protocolized, with a target heart rate of 80-90/min~Esmolol: Esmolol infusion"
11282955|NCT02841241|FG000|Participant Flow|Esmolol|"Esmolol infusion, started without bolus, with slow upward titration to a maximum infusion rate is protocolized, with a target heart rate of 80-90/min~Esmolol: Esmolol infusion"
11282956|NCT02841241|OG000|Outcome|Esmolol|"Esmolol infusion, started without bolus, with slow upward titration to a maximum infusion rate is protocolized, with a target heart rate of 80-90/min~Esmolol: Esmolol infusion"
11282957|NCT02841241|EG000|Reported Event|Esmolol|"Esmolol infusion, started without bolus, with slow upward titration to a maximum infusion rate is protocolized, with a target heart rate of 80-90/min~Esmolol: Esmolol infusion"
11282958|NCT02841267|BG000|Baseline|Cohort 1 - Low Dose|4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
11282959|NCT02841267|BG001|Baseline|Cohort 2 - Middle Dose|7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
11282960|NCT02841267|BG002|Baseline|Cohort 3 - High Dose|8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
11282961|NCT02841267|BG003|Baseline|Total|Total of all reporting groups
11282962|NCT02841267|FG000|Participant Flow|Low Dose, Cohort 1|"4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.~PF 06252616"
11282963|NCT02841267|FG001|Participant Flow|Middle Dose, Cohort 2|"8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.~PF 06252616"
11282964|NCT02841267|FG002|Participant Flow|High Dose, Cohort 3|"8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.~PF 06252616"
11282965|NCT02841267|OG000|Outcome|Cohort 1|4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
11282966|NCT02841267|OG001|Outcome|Cohort 2, Middle Dose|7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
11282967|NCT02841267|OG002|Outcome|Cohort 3, High Dose|8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
11282968|NCT02841267|OG000|Outcome|Cohort 1 - Low Dose|4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
11282969|NCT02841267|OG001|Outcome|Cohort 2 - Middle Dose|7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
10970540|NCT00910910|EG000|Reported Event|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide was administered by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
11282970|NCT02841267|OG002|Outcome|Cohort 3 - High Dose|8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
11282971|NCT02841267|EG000|Reported Event|Lead-in|All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts.
11282972|NCT02841267|EG001|Reported Event|Cohort 1 - Low Dose|Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks.
11282973|NCT02841267|EG002|Reported Event|Cohort 1 - High Dose|Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
11282974|NCT02841267|EG003|Reported Event|Cohort 1 Extension|Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks.
11282975|NCT02841267|EG004|Reported Event|Cohort 2|Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
11282976|NCT02841267|EG005|Reported Event|Cohort 2 Extension|Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks.
11282977|NCT02841267|EG006|Reported Event|Cohort 3|Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
11282978|NCT02841267|EG007|Reported Event|Cohort 3 Extension|Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks.
11282979|NCT02841397|BG000|Baseline|Test Group|"All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.~Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index"
11282980|NCT02841397|FG000|Participant Flow|Test Group|"All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.~Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index"
11282981|NCT02841397|OG000|Outcome|Test Group|"All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.~Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index"
11282982|NCT02841397|EG000|Reported Event|Test Group|"All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.~Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index"
11282983|NCT02841449|BG000|Baseline|Hypohydrated First, Then Rehydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 3 mL/kg body mass to consume over the rest of the day (e.g. a 75 kg participantwould consume 225 mL water. After a 3-35 day washout, they will repeat the protocol but after the heat tent be given 40 mL/kg body mass + 150 % body mass losses from the heat tent in water.~Hypohydrated: Participants remain hypohydrated after the heat tent procedure"
11282984|NCT02841449|BG001|Baseline|Rehydrated First, Then Hypohydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 40 mL/kg body mass plus 150 % of their water losses (from the heat tent procedure) over the rest of the day (e.g. a 75 kg participant and lost 1 % of their body mass in the heat tent (0.75 kg) would consume 3000 mL + 1125 mL [750 g * 1.5], totalling 4125 mL). Following a 3-35 d washout, participants would then repeat the protocol but after the heat tent be given 3 mL/kg body mass of water to consume over the rest of the day.~Rehydrated: Participants rehydrate after the heat tent procedure"
11282985|NCT02841449|BG002|Baseline|Total|Total of all reporting groups
11282986|NCT02841449|FG000|Participant Flow|Hypohydrated First, Then Rehydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 3 mL/kg body mass to consume over the rest of the day (e.g. a 75 kg participantwould consume 225 mL water. After a 3-35 day washout, they will repeat the protocol but after the heat tent be given 40 mL/kg body mass + 150 % body mass losses from the heat tent in water.~Hypohydrated: Participants remain hypohydrated after the heat tent procedure"
11282987|NCT02841449|FG001|Participant Flow|Rehydrated First, Then Hypohydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 40 mL/kg body mass plus 150 % of their water losses (from the heat tent procedure) over the rest of the day (e.g. a 75 kg participant and lost 1 % of their body mass in the heat tent (0.75 kg) would consume 3000 mL + 1125 mL [750 g * 1.5], totalling 4125 mL). Following a 3-35 d washout, participants would then repeat the protocol but after the heat tent be given 3 mL/kg body mass of water to consume over the rest of the day.~Rehydrated: Participants rehydrate after the heat tent procedure"
11282988|NCT02841449|OG000|Outcome|Hypohydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 3 mL/kg lean body mass to consume over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass would consume 191 mL water [63.75 kg * 3 mL])~Hypohydrated: Participants remain hypohydrated after the heat tent procedure"
11282989|NCT02841449|OG001|Outcome|Rehydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 40 mL/kg lean body mass plus 150 % of their water losses (from the heat tent procedure) over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass and lost 1 % of their body mass in the heat tent (0.75 kg) would consume 2550 mL [63.75 kg * 40 mL] + 1125 mL [750 g * 1.5], totalling 3675 mL).~Rehydrated: Participants rehydrate after the heat tent procedure"
10970541|NCT00910910|EG001|Reported Event|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months
10970542|NCT00910962|BG000|Baseline|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
10970543|NCT00910962|BG001|Baseline|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
10970544|NCT00910962|BG002|Baseline|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
10970545|NCT00910962|BG003|Baseline|Total|Total of all reporting groups
10970546|NCT00910962|FG000|Participant Flow|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
10970547|NCT00910962|FG001|Participant Flow|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 milligrams (mg) starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
10970548|NCT00910962|FG002|Participant Flow|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
10970549|NCT00910962|OG000|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
10970550|NCT00910962|OG001|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
10970551|NCT00910962|OG002|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
11282990|NCT02841449|EG000|Reported Event|Hypohydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 3 mL/kg lean body mass to consume over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass would consume 191 mL water [63.75 kg * 3 mL])~Hypohydrated: Participants remain hypohydrated after the heat tent procedure"
10970552|NCT00910962|OG003|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
10970553|NCT00910962|EG000|Reported Event|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
10970554|NCT00910962|EG001|Reported Event|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
10970555|NCT00910962|EG002|Reported Event|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
10970556|NCT00910962|EG003|Reported Event|A and B Comb (C)|A combined data for eligible participants from arm A and arm B were presented.
10970557|NCT00910988|BG000|Baseline|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
10970558|NCT00910988|BG001|Baseline|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
10970559|NCT00910988|BG002|Baseline|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
10970560|NCT00910988|BG003|Baseline|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
10970561|NCT00910988|BG004|Baseline|Total|Total of all reporting groups
10970562|NCT00910988|FG000|Participant Flow|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
10970563|NCT00910988|FG001|Participant Flow|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
10970564|NCT00910988|FG002|Participant Flow|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
10970565|NCT00910988|FG003|Participant Flow|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
10970566|NCT00910988|OG000|Outcome|Olanzapine (Drug/Placebo)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
10970567|NCT00910988|OG001|Outcome|Olanzapine (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
10970568|NCT00910988|OG002|Outcome|Olanzapine (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
10970569|NCT00910988|OG003|Outcome|Olanzapine (Placebo/Drug)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
10970570|NCT00910988|OG004|Outcome|Ziprasidone (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
10970571|NCT00910988|OG005|Outcome|Ziprasidone (Placebo/Drug)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
10970572|NCT00910988|OG006|Outcome|Ziprasidone (Drug/Placebo)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
10970573|NCT00910988|OG007|Outcome|Ziprasidone (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
10970574|NCT00910988|OG000|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
10970575|NCT00910988|OG001|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
10970576|NCT00910988|OG002|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
10970577|NCT00910988|OG003|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
10970578|NCT00910988|OG004|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
10970579|NCT00910988|OG005|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
10970580|NCT00910988|OG006|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
10970581|NCT00910988|OG007|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
10970582|NCT00910988|EG000|Reported Event|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
10970583|NCT00910988|EG001|Reported Event|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
10970584|NCT00910988|EG002|Reported Event|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
10970585|NCT00910988|EG003|Reported Event|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
10970586|NCT00910988|EG004|Reported Event|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
10970587|NCT00910988|EG005|Reported Event|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
10970588|NCT00910988|EG006|Reported Event|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
10970589|NCT00910988|EG007|Reported Event|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
10970590|NCT00911144|BG000|Baseline|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970591|NCT00911144|BG001|Baseline|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970592|NCT00911144|BG002|Baseline|Total|Total of all reporting groups
10970593|NCT00911144|FG000|Participant Flow|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970594|NCT00911144|FG001|Participant Flow|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970595|NCT00911144|OG000|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970596|NCT00911144|OG001|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970597|NCT00911144|EG000|Reported Event|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970598|NCT00911144|EG001|Reported Event|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
10970599|NCT00911157|BG000|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
10970600|NCT00911157|BG001|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
10970601|NCT00911157|BG002|Baseline|Total|Total of all reporting groups
10970602|NCT00911157|FG000|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
11282991|NCT02841449|EG001|Reported Event|Rehydrated|"After being dehydrated in the heat tent, participants in this trial arm will be given 40 mL/kg lean body mass plus 150 % of their water losses (from the heat tent procedure) over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass and lost 1 % of their body mass in the heat tent (0.75 kg) would consume 2550 mL [63.75 kg * 40 mL] + 1125 mL [750 g * 1.5], totalling 3675 mL).~Rehydrated: Participants rehydrate after the heat tent procedure"
11282992|NCT02841709|BG000|Baseline|All Study Participants|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11282993|NCT02841709|FG000|Participant Flow|Sequence 1 (D4, D2, D3, D1 and P)|Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
11282994|NCT02841709|FG001|Participant Flow|Sequence 2 (D2, P, D4, D3 and D1)|Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D2, P, D4, D3 and D1, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
11282995|NCT02841709|FG002|Participant Flow|Sequence 3 (D3, D1, D2, P and D4)|Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D3, D1, D2, P and D4, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
11282996|NCT02841709|FG003|Participant Flow|Sequence 4 (P, D4, D1, D2 and D3)|Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: P, D4, D1, D2, and D3, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
11282997|NCT02841709|FG004|Participant Flow|Sequence 5 (D1, D3, P, D4 and D2)|Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
10970603|NCT00911157|FG001|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
11282998|NCT02841709|OG000|Outcome|ACT-541468 5 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11282999|NCT02841709|OG001|Outcome|ACT-541468 10 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283000|NCT02841709|OG002|Outcome|ACT-541468 25 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283001|NCT02841709|OG003|Outcome|ACT-541468 50 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283002|NCT02841709|OG004|Outcome|Placebo|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283003|NCT02841709|EG000|Reported Event|Single-blind Placebo (Run-in Period)|"Single-blind placebo was administered during the run-in period.~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11337693|NCT03591146|OG000|Outcome|TLC590 190mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11092405|NCT01539642|OG000|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11283004|NCT02841709|EG001|Reported Event|Placebo|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283005|NCT02841709|EG002|Reported Event|ACT-541468 5 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283006|NCT02841709|EG003|Reported Event|ACT-541468 10 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283007|NCT02841709|EG004|Reported Event|ACT-541468 25 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283008|NCT02841709|EG005|Reported Event|ACT-541468 50 mg|"Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.~ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg~Placebo: Capsules for oral administration matching the ACT-541468 capsules"
11283009|NCT02841787|BG000|Baseline|Individual Internet Intervention (III)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
11283010|NCT02841787|BG001|Baseline|Internet Intervention With Peer Support (II+PS)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
11283011|NCT02841787|BG002|Baseline|Waitlist Control (WLC)|WLC participants received access to the III following the 8-week waiting period.
11283012|NCT02841787|BG003|Baseline|Total|Total of all reporting groups
11283013|NCT02841787|FG000|Participant Flow|Individual Internet Intervention (III)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
11283014|NCT02841787|FG001|Participant Flow|Internet Intervention With Peer Support (II+PS)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
11283015|NCT02841787|FG002|Participant Flow|Waitlist Control (WLC)|WLC participants received access to the III following the 8-week waiting period.
11283016|NCT02841787|OG000|Outcome|Individual Internet Intervention (III)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
11283017|NCT02841787|OG001|Outcome|Internet Intervention With Peer Support (II+PS)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
11283018|NCT02841787|OG002|Outcome|Waitlist Control (WLC)|WLC participants received access to the III following the 8-week waiting period.
11283019|NCT02841787|EG000|Reported Event|Individual Internet Intervention (III)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
11283020|NCT02841787|EG001|Reported Event|Internet Intervention With Peer Support (II+PS)|Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
11283021|NCT02841787|EG002|Reported Event|Waitlist Control (WLC)|WLC participants received access to the III following the 8-week waiting period.
11283022|NCT02842060|BG000|Baseline|myDEx Intervention|"The proposed intervention will consist of a 6-session web-based program. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.~myDEx: myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices."
11337694|NCT03591146|OG001|Outcome|TLC590 380mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11283023|NCT02842060|BG001|Baseline|Non-tailored HIV Prevention|"The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.~NTHP: The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention."
11283024|NCT02842060|BG002|Baseline|Total|Total of all reporting groups
11283025|NCT02842060|FG000|Participant Flow|myDEx Intervention|"The proposed intervention will consist of a 6-session web-based program. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.~myDEx: myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices."
11283026|NCT02842060|FG001|Participant Flow|Non-tailored HIV Prevention|"The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.~NTHP: The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention."
11283027|NCT02842060|OG000|Outcome|myDEx Intervention|"The proposed intervention will consist of a 6-session web-based program. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.~myDEx: myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices."
11283028|NCT02842060|OG001|Outcome|Non-tailored HIV Prevention|"The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.~NTHP: The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention."
11283029|NCT02842060|EG000|Reported Event|myDEx Intervention|"The proposed intervention will consist of a 6-session web-based program. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.~myDEx: myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices."
11283030|NCT02842060|EG001|Reported Event|Non-tailored HIV Prevention|"The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.~NTHP: The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention."
11092406|NCT01539642|OG001|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
11092407|NCT01539642|EG000|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11283031|NCT02842073|BG000|Baseline|Naltrexone and Buproprion|Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
11283032|NCT02842073|FG000|Participant Flow|Naltrexone and Buproprion|Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
11283033|NCT02842073|OG000|Outcome|Naltrexone and Buproprion|Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
11283034|NCT02842073|EG000|Reported Event|Naltrexone and Buproprion|Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
11283035|NCT02842086|BG000|Baseline|Descovy (DVY)|Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283036|NCT02842086|BG001|Baseline|Truvada (TVD)|Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283037|NCT02842086|BG002|Baseline|Total|Total of all reporting groups
11283038|NCT02842086|FG000|Participant Flow|Descovy (DVY)|Blinded Phase: Descovy (DVY; emtricitabine/tenofovir alafenamide [F/TAF] 200/25 mg) fixed-dose combination (FDC) tablet plus placebo-to-match Truvada (TVD) (emtricitabine/tenofovir disoproxil fumarate [F/TDF] 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283039|NCT02842086|FG001|Participant Flow|Truvada (TVD)|Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283040|NCT02842086|OG000|Outcome|Descovy (DVY)|Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283041|NCT02842086|OG001|Outcome|Truvada (TVD)|Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283042|NCT02842086|EG000|Reported Event|Descovy (DVY)|DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283043|NCT02842086|EG001|Reported Event|Truvada (TVD)|TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
11283044|NCT02842151|BG000|Baseline|Overall|Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF.
11283045|NCT02842151|FG000|Participant Flow|Overall|Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF.
11283046|NCT02842151|OG000|Outcome|Manifest Refraction|Standard manifest refraction assessed with an ETDRS chart using a phoropter
11283047|NCT02842151|OG001|Outcome|Autorefraction|Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer
11283048|NCT02842151|EG000|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with units of eyes.
11283049|NCT02842151|EG001|Reported Event|Non-ocular Adverse Events|At risk population for non-ocular adverse events is included with units of subjects.
11283050|NCT02842242|BG000|Baseline|Cohort A|Mavacamten 10 to 20 mg/d without background medications
11283051|NCT02842242|BG001|Baseline|Cohort B|Mavacamten 2 to 5 mg/d with beta-blockers allowed.
11283052|NCT02842242|BG002|Baseline|Total|Total of all reporting groups
11283053|NCT02842242|FG000|Participant Flow|Cohort A|Mavacamten 10 to 20 mg/d without background medications
11283054|NCT02842242|FG001|Participant Flow|Cohort B|Mavacamten 2 to 5 mg/d with beta-blockers allowed.
11283055|NCT02842242|OG000|Outcome|Cohort A|Mavacamten 10 to 20 mg/d without background medications
11283056|NCT02842242|OG001|Outcome|Cohort B|Mavacamten 2 to 5 mg/d with beta-blockers allowed.
11283057|NCT02842242|EG000|Reported Event|Cohort A|Mavacamten 10 to 20 mg/d without background medications
11283058|NCT02842242|EG001|Reported Event|Cohort B|Mavacamten 2 to 5 mg/d with beta-blockers allowed.
11283059|NCT02842736|BG000|Baseline|Endometrial Cryoablation|Cerene(R) Cryotherapy Device
11283060|NCT02842736|FG000|Participant Flow|Endometrial Cryoablation|Cerene(R) Cryotherapy Device
11283061|NCT02842736|OG000|Outcome|Endometrial Cryoablation|Cerene(R) Cryotherapy Device
11283062|NCT02842736|EG000|Reported Event|Endometrial Cryoablation|Cerene(R) Cryotherapy Device
11283063|NCT02843178|BG000|Baseline|1: Distributed, Targeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283064|NCT02843178|BG001|Baseline|2: Lump Sum, Targeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283065|NCT02843178|BG002|Baseline|3: Distributed, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283066|NCT02843178|BG003|Baseline|4: Lump Sum, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283067|NCT02843178|BG004|Baseline|Total|Total of all reporting groups
11283068|NCT02843178|FG000|Participant Flow|1: Distributed, Targeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283069|NCT02843178|FG001|Participant Flow|2: Lump Sum, Targeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283070|NCT02843178|FG002|Participant Flow|3: Distributed, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283071|NCT02843178|FG003|Participant Flow|4: Lump Sum, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283072|NCT02843178|OG000|Outcome|1: Distributed, Targeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283073|NCT02843178|OG001|Outcome|2: Lump Sum, Targeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283074|NCT02843178|OG002|Outcome|3: Distributed, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283075|NCT02843178|OG003|Outcome|4: Lump Sum, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283076|NCT02843178|EG000|Reported Event|1: Distributed, Targeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283077|NCT02843178|EG001|Reported Event|2: Lump Sum, Targeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283078|NCT02843178|EG002|Reported Event|3: Distributed, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11283079|NCT02843178|EG003|Reported Event|4: Lump Sum, Untargeted Vouchers|"Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.~Vouchers: A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill."
11287152|NCT02898662|BG000|Baseline|AZD1419|Participants received AZD1419 for inhalation via nebuliser solution (up to 13 doses). All participants received 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of AZD1419 on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving AZD1419 dose 10.
11283080|NCT02843529|BG000|Baseline|Prodromal AD (MCI)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity odaily life, instrumental activity of the daily life, depression scale)"
11283081|NCT02843529|BG001|Baseline|Preclinical AD (Cognitively Normal)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily"
11283082|NCT02843529|BG002|Baseline|Total|Total of all reporting groups
11283083|NCT02843529|FG000|Participant Flow|Prodromal AD (MCI)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale)"
11283084|NCT02843529|FG001|Participant Flow|Preclinical AD (Cognitively Normal)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily"
11283085|NCT02843529|OG000|Outcome|Prodromal AD (MCI)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale), stand"
11283086|NCT02843529|OG001|Outcome|Preclinical AD (Cognitively Normal)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily"
11283087|NCT02843529|EG000|Reported Event|Prodromal AD (MCI)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale)"
11283088|NCT02843529|EG001|Reported Event|Preclinical AD (Cognitively Normal)|"Altoida: neuropsychological, MRI, EEG and CSF biomarkers~Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).~Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily"
11283089|NCT02843659|BG000|Baseline|BMS-931699/Lulizumab Injection|(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
11283090|NCT02843659|BG001|Baseline|BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)|For oral administration, 350 mg
11283091|NCT02843659|BG002|Baseline|Placebo|For BMS-986142 50 mg tablet (round) or 150 mg tablet
11283092|NCT02843659|BG003|Baseline|Total|Total of all reporting groups
11283093|NCT02843659|FG000|Participant Flow|BMS-931699/Lulizumab Injection|(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
11283094|NCT02843659|FG001|Participant Flow|BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)|For oral administration, 350 mg
11283095|NCT02843659|FG002|Participant Flow|Placebo|For BMS-986142 50 mg tablet (round) or 150 mg tablet
11283096|NCT02843659|OG000|Outcome|BMS-931699/Lulizumab Injection|(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
11283097|NCT02843659|OG001|Outcome|BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)|For oral administration, 350 mg
11283098|NCT02843659|OG002|Outcome|Placebo|For BMS-986142 50 mg tablet (round) or 150 mg tablet
11283099|NCT02843659|EG000|Reported Event|Placebo|Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.
11283100|NCT02843659|EG001|Reported Event|Lulizumab (BMS-931699) 12.5mg QW|Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.
11283101|NCT02843659|EG002|Reported Event|BMS-986142 350 mg QD|Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.
11283102|NCT02844439|BG000|Baseline|Total: All Subjects|Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified glioblastoma and/or EGFRvIII^pos variant
11283103|NCT02844439|FG000|Participant Flow|Total|Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII^pos glioblastoma
11283104|NCT02844439|OG000|Outcome|Total|Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII^pos variant
11283105|NCT02844439|OG001|Outcome|Sub-population A|Subjects with EGFR gene-amplified glioblastoma
11283106|NCT02844439|OG002|Outcome|Sub-population B|Subjects with EGFR gene-amplified and EGFRvIII^pos variant glioblastoma (Subset of Sub-population A)
11283107|NCT02844439|OG000|Outcome|Total|Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII^pos glioblastoma
11283108|NCT02844439|OG001|Outcome|Sub-population A|Subjects with EGFR Gene-amplified Glioblastoma
11283109|NCT02844439|OG002|Outcome|Sub-population B|Subjects with EGFR gene-amplified and EGFRvIII^pos glioblastoma (Subset of Sub-population A)
11283110|NCT02844439|EG000|Reported Event|Total|Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII^pos variant glioblastoma. Includes 24 subjects who had EGFR gene-amplified (Sub-population A, 11 subjects who had EGFRvIII^pos and EGFR gene-amplified (Sub-population B which is a subset of Sub-population A) and 16 subjects who were in neither sub-population
11283111|NCT02844439|EG001|Reported Event|Sub-population A|Subjects with EGFR gene-amplified glioblastoma
11283112|NCT02844439|EG002|Reported Event|Sub-population B|Subjects with EGFRvIII^pos variant glioblastoma (Subset of Sub-population A)
11283113|NCT02844543|BG000|Baseline|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
11283114|NCT02844543|FG000|Participant Flow|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
11283115|NCT02844543|OG000|Outcome|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
11283116|NCT02844543|EG000|Reported Event|Athletes|Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
11283117|NCT02844569|BG000|Baseline|Test|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site."
11283118|NCT02844569|BG001|Baseline|Control|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site."
11283119|NCT02844569|BG002|Baseline|Total|Total of all reporting groups
11337695|NCT03591146|OG002|Outcome|TLC570mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11215033|NCT02296242|OG002|Outcome|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215034|NCT02296242|OG003|Outcome|Cohort-expansion RAS(+) & RAS(-) Groups|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215035|NCT02296242|OG000|Outcome|Dose-escalation|"Patients received 300-750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215036|NCT02296242|OG001|Outcome|Cohort-expansion|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215037|NCT02296242|OG000|Outcome|Cohort-expansion RAS(+) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215038|NCT02296242|OG001|Outcome|Cohort-expansion RAS(-) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215039|NCT02296242|EG000|Reported Event|Dose-escalation 300mg b.i.d. Cohort|"Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215040|NCT02296242|EG001|Reported Event|Dose-escalation 600mg b.i.d. Cohort|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215041|NCT02296242|EG002|Reported Event|Dose-escalation 750mg b.i.d. Cohort|"Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle)."
11215042|NCT02296242|EG003|Reported Event|Cohort-expansion RAS(+) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215043|NCT02296242|EG004|Reported Event|Cohort-expansion RAS(-) Group|"Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a Cycle). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs."
11215044|NCT02296320|BG000|Baseline|Placebo|Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
11215045|NCT02296320|BG001|Baseline|MEDI4893 2000 mg|Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
11215046|NCT02296320|BG002|Baseline|MEDI4893 5000 mg|Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
11215047|NCT02296320|BG003|Baseline|Total|Total of all reporting groups
11215048|NCT02296320|FG000|Participant Flow|Placebo|Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
11215049|NCT02296320|FG001|Participant Flow|MEDI4893 2000 mg|Participants received a single IV dose of MEDI4893 2000 milligrams (mg) on Day 1 of the study.
11215050|NCT02296320|FG002|Participant Flow|MEDI4893 5000 mg|Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
11215051|NCT02296320|OG000|Outcome|Placebo|Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
11215052|NCT02296320|OG001|Outcome|MEDI4893 2000 mg|Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
11215053|NCT02296320|OG002|Outcome|MEDI4893 5000 mg|Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
11215054|NCT02296320|OG000|Outcome|MEDI4893 2000 mg|Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
11215055|NCT02296320|OG001|Outcome|MEDI4893 5000 mg|Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
11215056|NCT02296320|EG000|Reported Event|Placebo|Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
11215057|NCT02296320|EG001|Reported Event|MEDI4893 2000 mg|Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
11215058|NCT02296320|EG002|Reported Event|MEDI4893 5000 mg|Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
11283120|NCT02844569|FG000|Participant Flow|Test|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site."
11283121|NCT02844569|FG001|Participant Flow|Control|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site."
11283122|NCT02844569|OG000|Outcome|Test|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site."
11283123|NCT02844569|OG001|Outcome|Control|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site."
11283124|NCT02844569|EG000|Reported Event|Test|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site."
11283125|NCT02844569|EG001|Reported Event|Control|"Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).~Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.~Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site."
11283126|NCT02844582|BG000|Baseline|Treatment (Cabazitaxel, Prednisone)|"Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Prednisone: Given PO"
11283127|NCT02844582|FG000|Participant Flow|Treatment (Cabazitaxel, Prednisone)|"Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Prednisone: Given PO"
11283128|NCT02844582|OG000|Outcome|Treatment (Cabazitaxel, Prednisone)|"Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Prednisone: Given PO"
11283129|NCT02844582|EG000|Reported Event|Treatment (Cabazitaxel, Prednisone)|"Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Cabazitaxel: Given IV~Prednisone: Given PO"
11283130|NCT02844920|BG000|Baseline|Fibroid Treatment|Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
11283131|NCT02844920|FG000|Participant Flow|Fibroid Treatment|"Intrauterine ultrasound guided radio-frequency ablation~Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids"
11283132|NCT02844920|OG000|Outcome|Fibroid Treatment|"Intrauterine ultrasound guided radio-frequency ablation~Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids"
11283133|NCT02844920|EG000|Reported Event|Fibroid Treatment|"Intrauterine ultrasound guided radio-frequency ablation~Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids"
11283134|NCT02844998|BG000|Baseline|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
11092408|NCT01539642|EG001|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
11092409|NCT01539694|BG000|Baseline|Overall|All participants/eyes received both treatment groups.
11092410|NCT01539694|FG000|Participant Flow|LD118033 Contact Lens Then PureVision Multifocal Contact Lens|"Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.~LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week~PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.~PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week"
11283135|NCT02844998|BG001|Baseline|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
11283136|NCT02844998|BG002|Baseline|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
11283137|NCT02844998|BG003|Baseline|Total|Total of all reporting groups
11283138|NCT02844998|FG000|Participant Flow|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
11283139|NCT02844998|FG001|Participant Flow|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.~Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)"
11283140|NCT02844998|FG002|Participant Flow|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category [<600 MET-min/week] according to the IPAQ classification)"
11283141|NCT02844998|OG000|Outcome|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
11283142|NCT02844998|OG001|Outcome|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week.~Physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week (To increase the physical activity level to minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)"
11283143|NCT02844998|OG002|Outcome|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (inactive category [<600 MET-min/week] according to the IPAQ classification)"
11283144|NCT02844998|EG000|Reported Event|Group 1|"Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)~dapoxetine 30 mg on demand: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries"
11283145|NCT02844998|EG001|Reported Event|Group 2|"Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
11283146|NCT02844998|EG002|Reported Event|Sham-controlled|"Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week.~physical activity: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week"
11283147|NCT02845336|BG000|Baseline|Celecoxib|"Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm~Celecoxib: celecoxib 100mg PO twice per day for 3 months~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283148|NCT02845336|BG001|Baseline|Control|"Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283149|NCT02845336|BG002|Baseline|Total|Total of all reporting groups
11283150|NCT02845336|FG000|Participant Flow|Celecoxib|"Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm~Celecoxib: celecoxib 100mg PO twice per day for 3 months~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283151|NCT02845336|FG001|Participant Flow|Control|"Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283152|NCT02845336|OG000|Outcome|Celecoxib|"Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm~Celecoxib: celecoxib 100mg PO twice per day for 3 months~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283153|NCT02845336|OG001|Outcome|Control|"Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283154|NCT02845336|EG000|Reported Event|Celecoxib|"Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm~Celecoxib: celecoxib 100mg PO twice per day for 3 months~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283155|NCT02845336|EG001|Reported Event|Control|"Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)~artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke."
11283156|NCT02845375|BG000|Baseline|PLACEBO|"Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283157|NCT02845375|BG001|Baseline|NEOSTIGMINE|"intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283158|NCT02845375|BG002|Baseline|SUGAMMADEX|"intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283159|NCT02845375|BG003|Baseline|Total|Total of all reporting groups
11283160|NCT02845375|FG000|Participant Flow|PLACEBO|"Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283161|NCT02845375|FG001|Participant Flow|NEOSTIGMINE|"intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283162|NCT02845375|FG002|Participant Flow|SUGAMMADEX|"intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283163|NCT02845375|OG000|Outcome|PLACEBO|"Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283164|NCT02845375|OG001|Outcome|NEOSTIGMINE|"intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283165|NCT02845375|OG002|Outcome|SUGAMMADEX|"intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283166|NCT02845375|EG000|Reported Event|PLACEBO|"Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Placebo: Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283167|NCT02845375|EG001|Reported Event|NEOSTIGMINE|"intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283168|NCT02845375|EG002|Reported Event|SUGAMMADEX|"intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.~Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained."
11283169|NCT02845674|BG000|Baseline|Group 1|"0.09% cyclosporine nanomicellar solution~OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution"
11283170|NCT02845674|BG001|Baseline|Group 2|OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
11283171|NCT02845674|BG002|Baseline|Total|Total of all reporting groups
11283172|NCT02845674|FG000|Participant Flow|OTX-101 0.09% to OTX-101 0.09%|One drop in each eye BID
11283173|NCT02845674|FG001|Participant Flow|Vehicle to OTX-101 0.09%|One drop in each eye BID
11283174|NCT02845674|OG000|Outcome|Group 1|OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
11283175|NCT02845674|OG001|Outcome|Group 2|OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
11283176|NCT02845674|EG000|Reported Event|Group 1|OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
11283177|NCT02845674|EG001|Reported Event|Group 2|OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
11283178|NCT02845700|BG000|Baseline|Sensory Retraining Treatment (SRT)|"The retraining portion (SRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are correct when a neutral response is given to solutions that are above the starting threshold (stronger malodor) and incorrect when a target is endorsed that is below the starting threshold (weaker malodor)."
11283179|NCT02845700|BG001|Baseline|Sham Neutral Training (SNT)|Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
11283180|NCT02845700|BG002|Baseline|Total|Total of all reporting groups
11337696|NCT03591146|OG003|Outcome|TLC590 475mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11283181|NCT02845700|FG000|Participant Flow|Perceptual Retraining Treatment (PRT)|"The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are correct when a neutral response is given to solutions that are above the starting threshold (stronger malodor) and incorrect when a target is endorsed that is below the starting threshold (weaker malodor)."
11283182|NCT02845700|FG001|Participant Flow|Sham Neutral Training (SNT)|Approximately half of the participants will be randomized to the Sham Neutral Training (SNT) ondition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the PRT. Following the one-month assessment, they will be given the option to complete the PRT.
11283183|NCT02845700|OG000|Outcome|Perceptual Retraining Treatment (PRT)|"The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are correct when a neutral response is given to solutions that are above the starting threshold (stronger malodor) and incorrect when a target is endorsed that is below the starting threshold (weaker malodor)."
11283184|NCT02845700|OG001|Outcome|Sham Neutral Training (SNT)|Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
11283185|NCT02845700|EG000|Reported Event|Sensory Retraining Treatment (SRT)|"The retraining portion (SRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are correct when a neutral response is given to solutions that are above the starting threshold (stronger malodor) and incorrect when a target is endorsed that is below the starting threshold (weaker malodor)."
11283186|NCT02845700|EG001|Reported Event|Sham Neutral Training (SNT)|Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
11283187|NCT02845752|BG000|Baseline|Stiolto Respimat, Then Placebo Respimat|Participants first received Stiolto Respimat inhaler (two actuations, once daily for 7 days). After a washout period of 14 days, participants will then received Placebo Respimat inhaler (two actuations, once daily for 7 days).
11283188|NCT02845752|BG001|Baseline|Placebo Respimat, Then Stiolto Respimat|Participants first received Placebo Respimat inhaler (two actuations, once daily for 7 days). After a washout period of 14 days, participants will then received Stiolto Respimat inhaler (two actuations, once daily for 7 days).
11283189|NCT02845752|BG002|Baseline|Total|Total of all reporting groups
11283190|NCT02845752|FG000|Participant Flow|Stiolto Respimat, Then Placebo Respimat|Participants first received Stiolto Respimat inhaler (two actuations, once daily for 7 days). After a washout period of 14 days, participants will then received Placebo Respimat inhaler (two actuations, once daily for 7 days).
11283191|NCT02845752|FG001|Participant Flow|Placebo Respimat, Then Stiolto Respimat|Participants first received Placebo Respimat inhaler (two actuations, once daily for 7 days). After a washout period of 14 days, participants will then received Stiolto Respimat inhaler (two actuations, once daily for 7 days).
11283192|NCT02845752|OG000|Outcome|Stiolto Respimat|Stiolto Respimat inhaler (two actuations, taken once daily for 7 days).
11283193|NCT02845752|OG001|Outcome|Placebo Respimat|Placebo Respimat inhaler (two actuations, taken once daily for 7 days).
10822110|NCT00074490|OG002|Outcome|Arm IVA (12-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
11283194|NCT02845752|EG000|Reported Event|Stiolto Respimat|Stiolto Respimat inhaler (two actuations, taken once daily for 7 days).
11283195|NCT02845752|EG001|Reported Event|Placebo Respimat|Placebo Respimat inhaler (two actuations, taken once daily for 7 days).
11283196|NCT02846233|BG000|Baseline|Treatment Group|"Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.~GLP1 receptor agonist: Albiglutide or Dulaglutide will be added to a basal insulin.~basal insulin: The participant will continue with the basal insulin.~SGLT2 inhibitor: Empagliflozin will be added to a basal insulin.~Metformin: The participant will continue with metformin."
11283197|NCT02846233|BG001|Baseline|Control Group|Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
11283198|NCT02846233|BG002|Baseline|Total|Total of all reporting groups
11337697|NCT03591146|OG004|Outcome|Naropin|"Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial~Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL"
11283199|NCT02846233|FG000|Participant Flow|Treatment Group|"Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.~GLP1 receptor agonist: Albiglutide or Dulaglutide will be added to a basal insulin.~basal insulin: The participant will continue with the basal insulin.~SGLT2 inhibitor: Empagliflozin will be added to a basal insulin.~Metformin: The participant will continue with metformin."
11283200|NCT02846233|FG001|Participant Flow|Control Group|Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
11283201|NCT02846233|OG000|Outcome|Treatment Group|"Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.~GLP1 receptor agonist: Albiglutide or Dulaglutide will be added to a basal insulin.~basal insulin: The participant will continue with the basal insulin.~SGLT2 inhibitor: Empagliflozin will be added to a basal insulin.~Metformin: The participant will continue with metformin."
11283202|NCT02846233|OG001|Outcome|Control Group|Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
11283203|NCT02846233|EG000|Reported Event|Treatment Group|"Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.~GLP1 receptor agonist: Albiglutide or Dulaglutide will be added to a basal insulin.~basal insulin: The participant will continue with the basal insulin.~SGLT2 inhibitor: Empagliflozin will be added to a basal insulin.~Metformin: The participant will continue with metformin."
11283204|NCT02846233|EG001|Reported Event|Control Group|Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
11283205|NCT02846324|BG000|Baseline|Placebo|"Parts A and B~Placebo: Placebo capsules"
11283206|NCT02846324|BG001|Baseline|GBT440 600 mg Dose|"Parts A and B Dose 1~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283207|NCT02846324|BG002|Baseline|GBT440 900 mg Dose|"Part A Dose 2~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11092411|NCT01539694|FG001|Participant Flow|PureVision Multifocal Contact Lens Then LD118033 Contact Lens|"PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.~PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.~Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.~LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week"
11283208|NCT02846324|BG003|Baseline|GBT440 1500 mg Dose|"Part B Dose 2; Overall Dose 3~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283209|NCT02846324|BG004|Baseline|Total|Total of all reporting groups
11283210|NCT02846324|FG000|Participant Flow|GBT440 600 mg Dose|"Parts A and B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283211|NCT02846324|FG001|Participant Flow|GBT440 900 mg Dose|"Part A~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283212|NCT02846324|FG002|Participant Flow|GBT440 1500 mg Dose|"Part B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283213|NCT02846324|FG003|Participant Flow|Placebo|"Parts A and B~Placebo: Placebo capsules"
11283214|NCT02846324|OG000|Outcome|Placebo|"Parts A and B~Placebo: Placebo capsules"
11283215|NCT02846324|OG001|Outcome|GBT440 600 mg Dose|"Parts A and B Dose 1~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283216|NCT02846324|OG002|Outcome|GBT440 900mg Dose|"Part A Dose 2~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283217|NCT02846324|OG003|Outcome|GBT440 1500mg Dose|"Part B Dose 2; Overall Dose 3~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283218|NCT02846324|OG001|Outcome|GBT440 600 mg Dose|"Parts A and B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283219|NCT02846324|OG002|Outcome|GBT440 900 mg Dose|"Part A~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283220|NCT02846324|OG003|Outcome|GBT440 1500 mg Dose|"Part B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283221|NCT02846324|OG001|Outcome|GBT440 Dose 1|"Parts A and B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283222|NCT02846324|OG002|Outcome|GBT440 Dose 2|"Part A~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283223|NCT02846324|OG003|Outcome|GBT440 Dose 3|"Part B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283224|NCT02846324|OG001|Outcome|GBT440 Dose 1|"Parts A and B Dose 1~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283225|NCT02846324|OG002|Outcome|GBT440 Dose 2|"Part A Dose 2~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283226|NCT02846324|OG003|Outcome|GBT440 Dose 3|"Part B Dose 2; Overall Dose 3~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283227|NCT02846324|EG000|Reported Event|Placebo|"Parts A and B~Placebo: Placebo capsules"
11283228|NCT02846324|EG001|Reported Event|GBT440 600 mg Dose|"Parts A and B Dose 1~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283229|NCT02846324|EG002|Reported Event|GBT440 900 mg Dose|"Part A Dose 2~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283230|NCT02846324|EG003|Reported Event|GBT440 1500 mg Dose|"Part B Dose 2; Overall Dose 3~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11283231|NCT02846415|BG000|Baseline|PID Group|"Experimental group receiving the Play Intervention for Dementia~Play Intervention for Dementia:~8 weekly sessions, 45-75 minutes each~Play with toys~Sessions will be facilitated by a play specialist, trained play assistants, and center staff."
11283232|NCT02846415|BG001|Baseline|Wait-list Control Group|Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
11283233|NCT02846415|BG002|Baseline|Total|Total of all reporting groups
11283234|NCT02846415|FG000|Participant Flow|PID Group|"Experimental group receiving the Play Intervention for Dementia~Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff."
11283235|NCT02846415|FG001|Participant Flow|Wait-list Control Group|Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
11283236|NCT02846415|OG000|Outcome|PID Group|"Experimental group receiving the Play Intervention for Dementia~Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff."
11283237|NCT02846415|OG001|Outcome|Wait-list Control Group|Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
11283238|NCT02846415|EG000|Reported Event|PID Group|"Experimental group receiving the Play Intervention for Dementia~Play Intervention for Dementia:~8 weekly session, 45-75 minutes each~Play with toys~Sessions will be facilitated by a play specialist, trained play assistants, and centre staff."
11283239|NCT02846415|EG001|Reported Event|Wait-list Control Group|Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
11283240|NCT02846558|BG000|Baseline|Calorie Restriction - Frequent Patient Communication|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
11283241|NCT02846558|BG001|Baseline|Calorie Restriction - Communication Standard of Care|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
11283242|NCT02846558|BG002|Baseline|Timing Restriction|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
11283243|NCT02846558|BG003|Baseline|No Diet Change|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
11283244|NCT02846558|BG004|Baseline|Total|Total of all reporting groups
11283245|NCT02846558|FG000|Participant Flow|Calorie Restriction - Frequent Patient Communication|"MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.~Frequent Patient Interaction: Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.~LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes."
11283246|NCT02846558|FG001|Participant Flow|Calorie Restriction - Communication Standard of Care|"MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.~LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes."
11283247|NCT02846558|FG002|Participant Flow|Timing Restriction|"MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.~Timing Restriction: Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day."
11283248|NCT02846558|FG003|Participant Flow|No Diet Change|MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index < 25 kg/m^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm
11283249|NCT02846558|OG000|Outcome|Calorie Restriction - Frequent Patient Communication|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
11283250|NCT02846558|OG001|Outcome|Calorie Restriction - Communication Standard of Care|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
11283251|NCT02846558|OG002|Outcome|Timing Restriction|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
11283252|NCT02846558|OG003|Outcome|No Diet Change|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
10820427|NCT00057876|BG001|Baseline|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
10820428|NCT00057876|BG002|Baseline|Total|Total of all reporting groups
11215059|NCT02296346|BG000|Baseline|Corticosteriod Arm|"Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.~SoluMedrol: Infusion of drug subcutaneously, once a month."
11215060|NCT02296346|BG001|Baseline|Extracorporeal Photopheresis|"Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:~ECP will be administered according to the following schedule:~Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks~Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body."
11215061|NCT02296346|BG002|Baseline|Total|Total of all reporting groups
11215062|NCT02296346|FG000|Participant Flow|Corticosteriod Arm|"Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.~SoluMedrol: Infusion of drug subcutaneously, once a month."
11215063|NCT02296346|FG001|Participant Flow|Extracorporeal Photopheresis|"Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:~ECP will be administered according to the following schedule:~Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks~Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body."
11215064|NCT02296346|OG000|Outcome|ECP Arm|Study participants assigned to ECP treatment
11215065|NCT02296346|OG001|Outcome|Corticosteroid Arm|Study participants assigned to corticosteroid treatment
11215066|NCT02296346|OG000|Outcome|Corticosteriod Arm|"Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.~SoluMedrol: Infusion of drug subcutaneously, once a month."
11215067|NCT02296346|OG001|Outcome|Extracorporeal Photopheresis|"Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:~ECP will be administered according to the following schedule:~Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks~Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body."
11215068|NCT02296346|EG000|Reported Event|Corticosteriod Arm|"Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.~SoluMedrol: Infusion of drug subcutaneously, once a month."
11215069|NCT02296346|EG001|Reported Event|Extracorporeal Photopheresis|"Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:~ECP will be administered according to the following schedule:~Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks~Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body."
11215070|NCT02296424|BG000|Baseline|Cohort 1|Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient's first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease
11215071|NCT02296424|BG001|Baseline|Cohort 2|"Dose interval prologation All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of this study~All participants in Part II of this study came from Part 1, So only Part 1 is shown here in Baseline Characteristics"
11215072|NCT02296424|BG002|Baseline|Total|Total of all reporting groups
11215073|NCT02296424|FG000|Participant Flow|Cohort 1|Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient's first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease
11215074|NCT02296424|FG001|Participant Flow|PART 1: Cohort 2|Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve
11215075|NCT02296424|FG002|Participant Flow|Dose Reduction|canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II
11215076|NCT02296424|FG003|Participant Flow|Dose Interval Prolongation|canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II
11283253|NCT02846558|OG000|Outcome|Calorie Restriction - Frequent Patient Communication|Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
11283254|NCT02846558|OG001|Outcome|Calorie Restriction - Communication Standard of Care|Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits.
11283255|NCT02846558|OG002|Outcome|Time Restriction|Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
11283256|NCT02846558|OG003|Outcome|No Diet Change|Participants make no changes to their normal diet.
11283257|NCT02846558|OG000|Outcome|Calorie Restriction - Adherent Participants|Participants still following a calorie restriction diet, continuous or intermittent, at the end of the 6 month period. Includes participants in both randomization arms (frequent communication and standard of care).
11283258|NCT02846558|OG001|Outcome|Calorie Restriction - Non-Adherent Participants|Participants who started in either the frequent communication or communication standard of care arms, following a calorie restriction diet, but who stopped the diet prior to the end of the 6-month study period.
11283259|NCT02846558|OG001|Outcome|Calorie Restriction - Communication Standard of Care|Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits
11283260|NCT02846558|EG000|Reported Event|Calorie Restriction - Frequent Patient Communication|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
11283261|NCT02846558|EG001|Reported Event|Calorie Restriction - Communication Standard of Care|Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
11283262|NCT02846558|EG002|Reported Event|Timing Restriction|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
11283263|NCT02846558|EG003|Reported Event|No Diet Change|Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
11287153|NCT02898662|BG001|Baseline|Placebo|Participants received placebo for inhalation via nebuliser solution (up to 13 doses). All participants received placebo to match 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of placebo on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving placebo dose 10.
11287154|NCT02898662|BG002|Baseline|Total|Total of all reporting groups
11287155|NCT02898662|FG000|Participant Flow|AZD1419|Participants received AZD1419 for inhalation via nebuliser solution (up to 13 doses). All participants received 4 milligrams (mg) AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of AZD1419 on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving AZD1419 dose 10.
11287156|NCT02898662|FG001|Participant Flow|Placebo|Participants received placebo for inhalation via nebuliser solution (up to 13 doses). All participants received placebo to match 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of placebo on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving placebo dose 10.
11287157|NCT02898662|OG000|Outcome|AZD1419|Participants received AZD1419 for inhalation via nebuliser solution (up to 13 doses). All participants received 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of AZD1419 on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving AZD1419 dose 10.
11287158|NCT02898662|OG001|Outcome|Placebo|Participants received placebo for inhalation via nebuliser solution (up to 13 doses). All participants received placebo to match 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of placebo on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving placebo dose 10.
11283264|NCT02846714|BG000|Baseline|FLARE Intervention|FLARE participants enrolled
11283265|NCT02846714|FG000|Participant Flow|FLARE Intervention|FLARE participants enrolled
11283266|NCT02846714|OG000|Outcome|FLARE Intervention|FLARE participants enrolled
11283267|NCT02846714|EG000|Reported Event|FLARE Intervention|FLARE participants enrolled
11283268|NCT02846740|BG000|Baseline|Adjunctive CES|"CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283269|NCT02846740|BG001|Baseline|Sham Control CES|"For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283270|NCT02846740|BG002|Baseline|Total|Total of all reporting groups
11283271|NCT02846740|FG000|Participant Flow|Adjunctive CES|"CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283272|NCT02846740|FG001|Participant Flow|Sham Control CES|"For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283273|NCT02846740|OG000|Outcome|Adjunctive CES|"CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283274|NCT02846740|OG001|Outcome|Sham Control CES|"For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283275|NCT02846740|EG000|Reported Event|Adjunctive CES|"CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283276|NCT02846740|EG001|Reported Event|Sham Control CES|"For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.~Alpha-Stim®.: cranial electrical stimulation~Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's)."
11283277|NCT02846779|BG000|Baseline|Low Intensity|"All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.~Low intensity: Low intensity telepharmacy outreach"
11283278|NCT02846779|BG001|Baseline|Moderate Intensity|"Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.~Moderate intensity: Moderate intensity telepharmacy outreach"
11283279|NCT02846779|BG002|Baseline|High Intensity|"Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.~High intensity: High intensity telepharmacy outreach"
11283280|NCT02846779|BG003|Baseline|Total|Total of all reporting groups
11283281|NCT02846779|FG000|Participant Flow|Low Intensity|"All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.~Low intensity: Low intensity telepharmacy outreach"
11283282|NCT02846779|FG001|Participant Flow|Moderate Intensity|"Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.~Moderate intensity: Moderate intensity telepharmacy outreach"
11283283|NCT02846779|FG002|Participant Flow|High Intensity|"Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.~High intensity: High intensity telepharmacy outreach"
11283284|NCT02846779|OG000|Outcome|Low Intensity|"All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.~Low intensity: Low intensity telepharmacy outreach"
11283285|NCT02846779|OG001|Outcome|Moderate Intensity|"Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.~Moderate intensity: Moderate intensity telepharmacy outreach"
11283286|NCT02846779|OG002|Outcome|High Intensity|"Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.~High intensity: High intensity telepharmacy outreach"
11283287|NCT02846779|EG000|Reported Event|Low Intensity|"All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.~Low intensity: Low intensity telepharmacy outreach"
11283288|NCT02846779|EG001|Reported Event|Moderate Intensity|"Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.~Moderate intensity: Moderate intensity telepharmacy outreach"
11283289|NCT02846779|EG002|Reported Event|High Intensity|"Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.~High intensity: High intensity telepharmacy outreach"
11283290|NCT02846792|BG000|Baseline|Treatment (Plinabulin, Nivolumab)|"Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV~Plinabulin: Given IV"
11283291|NCT02846792|FG000|Participant Flow|Treatment (Plinabulin, Nivolumab)|"Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV~Plinabulin: Given IV"
11283292|NCT02846792|OG000|Outcome|Treatment (Plinabulin, Nivolumab)|"Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV~Plinabulin: Given IV"
11283293|NCT02846792|EG000|Reported Event|Treatment (Plinabulin, Nivolumab)|"Patients receive plinabulin IV over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Nivolumab: Given IV~Plinabulin: Given IV"
11283294|NCT02847169|BG000|Baseline|Overall Participants|"Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
11092412|NCT01539694|OG000|Outcome|LD118033 Contact Lens|"Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.~LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week"
11092413|NCT01539694|OG001|Outcome|PureVision Multifocal Contact Lens|"PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.~PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week."
11283295|NCT02847169|FG000|Participant Flow|Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens|"Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
11283296|NCT02847169|FG001|Participant Flow|Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens|"Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
11283297|NCT02847169|OG000|Outcome|Habitual Lens (Baseline)|Habitual data was assessed at baseline.
11283298|NCT02847169|OG001|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
11283299|NCT02847169|OG002|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
11283300|NCT02847169|OG003|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
11283301|NCT02847169|OG004|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
11283302|NCT02847169|OG000|Outcome|Optimal Centration|Lens centration
11283303|NCT02847169|OG001|Outcome|Decentered Slightly|Lens centration
11283304|NCT02847169|OG002|Outcome|Substantially Decentered|Lens centration
11283305|NCT02847169|OG000|Outcome|Habitual Lens (Baseline)|Habitual lens assessed at baseline.
11283306|NCT02847169|OG000|Outcome|Habitual Toric Lens|Habitual data was assessed at baseline.
11283307|NCT02847169|OG001|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
11092414|NCT01539694|EG000|Reported Event|LD118033 Contact Lens|"Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.~LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week"
11283308|NCT02847169|OG002|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
11283309|NCT02847169|OG003|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
11283310|NCT02847169|OG004|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
11283311|NCT02847169|OG000|Outcome|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
11283312|NCT02847169|OG001|Outcome|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
11283313|NCT02847169|OG000|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
11283314|NCT02847169|EG000|Reported Event|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1 toric lens: toric contact lens"
11283315|NCT02847169|EG001|Reported Event|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D toric lens: toric contact lens"
11283316|NCT02847182|BG000|Baseline|Cord Blood Infusion, Then Placebo Infusion|"Subjects will be randomized to receive a cord blood infusion at the baseline visit, followed by a placebo infusion at 6 months. The cord blood will be autologous (if available) or unrelated cord blood. The placebo is an acellular media product similar in both appearance and odor.~Cord Blood Infusion~Placebo"
11283317|NCT02847182|BG001|Baseline|Placebo Infusion, Then Cord Blood Infusion|"Subjects will be randomized to receive a placebo infusion at the baseline visit, followed by a cord blood infusion at 6 months. The placebo is an acellular media product similar in both appearance and odor. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion~Placebo"
11283318|NCT02847182|BG002|Baseline|Total|Total of all reporting groups
11283319|NCT02847182|FG000|Participant Flow|Cord Blood Infusion, Then Placebo Infusion|"Subjects will be randomized to receive a cord blood infusion at the baseline visit, followed by a placebo infusion at 6 months. The cord blood will be autologous (if available) or unrelated cord blood. The placebo is an acellular media product similar in both appearance and odor.~Cord Blood Infusion~Placebo"
11283320|NCT02847182|FG001|Participant Flow|Placebo Infusion, Then Cord Blood Infusion|"Subjects will be randomized to receive a placebo infusion at the baseline visit, followed by a cord blood infusion at 6 months. The placebo is an acellular media product similar in both appearance and odor. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion~Placebo"
11283321|NCT02847182|OG000|Outcome|Cord Blood Infusion - 6 Months|"Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion"
11283322|NCT02847182|OG001|Outcome|Placebo Infusion - 6 Months|"Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor.~Placebo"
11283323|NCT02847182|OG000|Outcome|Cord Blood Infusion - 12 Months|"Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion"
11283324|NCT02847182|OG001|Outcome|Placebo Infusion - 12 Months|"Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor.~Placebo"
11283325|NCT02847182|OG002|Outcome|Cord Blood Infusion - 12 Months|"Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion"
11283326|NCT02847182|OG003|Outcome|Placebo Infusion - 12 Months|"Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor.~Placebo"
11283327|NCT02847182|EG000|Reported Event|Cord Blood Infusion - 6 Months|"Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion"
11283328|NCT02847182|EG001|Reported Event|Placebo Infusion - 6 Months|"Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor.~Placebo"
11283329|NCT02847182|EG002|Reported Event|Cord Blood Infusion - 12 Months|"Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood.~Cord Blood Infusion"
11283330|NCT02847182|EG003|Reported Event|Placebo Infusion - 12 Months|"Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor.~Placebo"
11092415|NCT01539694|EG001|Reported Event|PureVision Multifocal Contact Lens|"PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.~PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week."
11092416|NCT01539759|BG000|Baseline|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
11283331|NCT02847260|BG000|Baseline|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
11283332|NCT02847260|FG000|Participant Flow|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
11283333|NCT02847260|OG000|Outcome|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
11283334|NCT02847260|EG000|Reported Event|Remodulin|Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
11283335|NCT02847494|BG000|Baseline|Control|"Metoclopramide 10mg IV+ dexamethasone 10mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~Dexamethasone: dexamethasone 10mg intramuscular injection"
11283336|NCT02847494|BG001|Baseline|Experimental|"Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection"
11283337|NCT02847494|BG002|Baseline|Total|Total of all reporting groups
11283338|NCT02847494|FG000|Participant Flow|Control|"Metoclopramide 10mg IV+ dexamethasone 10mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~Dexamethasone: dexamethasone 10mg intramuscular injection"
11283339|NCT02847494|FG001|Participant Flow|Experimental|"Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection"
11283340|NCT02847494|OG000|Outcome|Control|"Metoclopramide 10mg IV+ dexamethasone 10mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~Dexamethasone: dexamethasone 10mg intramuscular injection"
11283341|NCT02847494|OG001|Outcome|Experimental|"Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection"
11283342|NCT02847494|EG000|Reported Event|Control|"Metoclopramide 10mg IV+ dexamethasone 10mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~Dexamethasone: dexamethasone 10mg intramuscular injection"
11283343|NCT02847494|EG001|Reported Event|Experimental|"Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM~metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes~methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection"
11283344|NCT02847650|BG000|Baseline|PF-06649751|Eligible participants were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; participants might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
11092417|NCT01539759|BG001|Baseline|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
11283345|NCT02847650|BG001|Baseline|Placebo|Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.
11283346|NCT02847650|BG002|Baseline|Total|Total of all reporting groups
11283347|NCT02847650|FG000|Participant Flow|PF-06649751|Eligible participants were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; participants might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
11092418|NCT01539759|BG002|Baseline|Total|Total of all reporting groups
11092419|NCT01539759|FG000|Participant Flow|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
11215077|NCT02296424|OG000|Outcome|Canakinumab Dose Reduction|Cohort 1 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
11215078|NCT02296424|OG001|Outcome|Canakinumab Dose Interval Prolongation|Cohort 2 In total, 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
11215079|NCT02296424|OG001|Outcome|Canakinumab Dose Interval Prolongation|Cohort 2 All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
11215080|NCT02296424|EG000|Reported Event|Part I|Part I
11215081|NCT02296424|EG001|Reported Event|Part II@Dose Reduction|Part II@Dose reduction
11215082|NCT02296424|EG002|Reported Event|Part II@Dose Interval@Prolongation|Part II@Dose interval@prolongation
11215083|NCT02296476|BG000|Baseline|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215084|NCT02296476|BG001|Baseline|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215085|NCT02296476|BG002|Baseline|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215086|NCT02296476|BG003|Baseline|Total|Total of all reporting groups
11215087|NCT02296476|FG000|Participant Flow|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215088|NCT02296476|FG001|Participant Flow|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215089|NCT02296476|FG002|Participant Flow|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215090|NCT02296476|OG000|Outcome|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215091|NCT02296476|OG001|Outcome|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215092|NCT02296476|OG002|Outcome|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215093|NCT02296476|EG000|Reported Event|MK-8628 80 mg|Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215094|NCT02296476|EG001|Reported Event|MK-8628 120 mg|Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215095|NCT02296476|EG002|Reported Event|MK-8628 160 mg|Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
11215096|NCT02296502|BG000|Baseline|Autism Spectrum Disorder (DSM IV & 5)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5
11215097|NCT02296502|BG001|Baseline|Autism Spectrum Disorder (DSM 5 Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV
11215098|NCT02296502|BG002|Baseline|Autism Spectrum Disorder (DSM IV Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5
11215099|NCT02296502|BG003|Baseline|Non-Autism Spectrum Disorder|"All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.~DSM: Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder"
11215100|NCT02296502|BG004|Baseline|Total|Total of all reporting groups
11215101|NCT02296502|FG000|Participant Flow|Autism Spectrum Disorder (DSM IV & 5)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5
11215102|NCT02296502|FG001|Participant Flow|Autism Spectrum Disorder (DSM 5 Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV
11215103|NCT02296502|FG002|Participant Flow|Autism Spectrum Disorder (DSM IV Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5
11215104|NCT02296502|FG003|Participant Flow|Non-Autism Spectrum Disorder|"All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.~DSM: Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder"
11215105|NCT02296502|OG000|Outcome|Both DSM-IV and DSM-5|Diagnosed with both DSM-IV and DSM-5 (concordant)
11215106|NCT02296502|OG001|Outcome|DSM-IV But Not DSM-5|Diagnosed with DSM-IV but not DSM-5 (discordant)
11215107|NCT02296502|OG000|Outcome|PDD NOS|Diagnosed PDD NOS
11215108|NCT02296502|OG001|Outcome|Asperger's|Diagnosed Asperger's
11215109|NCT02296502|OG002|Outcome|Autistic Disorder|Diagnosed Autistic Disorder
11215110|NCT02296502|OG003|Outcome|ASD Total|Diagnosed with PDD-NOS, Asperger's, or Autistic Disorder.
11215111|NCT02296502|OG004|Outcome|Total|Total including not diagnosed
11215112|NCT02296502|EG000|Reported Event|Total SubjectsAutism Spectrum Disorder (DSM IV & 5)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5
11215113|NCT02296502|EG001|Reported Event|Autism Spectrum Disorder (DSM 5 Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV
11283348|NCT02847650|FG001|Participant Flow|Placebo|Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.
11283349|NCT02847650|OG000|Outcome|PF-06649751|Eligible participants were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; participants might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
11283350|NCT02847650|OG001|Outcome|Placebo|Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.
11283351|NCT02847650|EG000|Reported Event|PF-06649751|Eligible participants were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; participants might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
11283352|NCT02847650|EG001|Reported Event|Placebo|Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.
11283353|NCT02847858|BG000|Baseline|Health-E You Intervention Arm|Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.
11283354|NCT02847858|BG001|Baseline|Control Arm|Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.
11283355|NCT02847858|BG002|Baseline|Total|Total of all reporting groups
11283356|NCT02847858|FG000|Participant Flow|Health-E You Intervention Arm|Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.
11283357|NCT02847858|FG001|Participant Flow|Control Arm|Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.
11283358|NCT02847858|OG000|Outcome|Intervention|Used Health-E You app in waiting room prior to clinical visit
11283359|NCT02847858|OG001|Outcome|Control|Usual care (app not offered)
11283360|NCT02847858|OG000|Outcome|Intervention|used Healthy-E You app in waiting room prior to clinical visit.
11283361|NCT02847858|OG001|Outcome|Control Group Participants|usual care (app not offered)
11283362|NCT02847858|OG001|Outcome|Control|usual care (app not offered)
11283363|NCT02847858|OG000|Outcome|Clinical Providers|Clinical providers in Health-E You Intervention Clinics
11283364|NCT02847858|OG000|Outcome|Intervention|Intervention Arm- completed Health-E You App
11283365|NCT02847858|EG000|Reported Event|Health-E You Intervention Arm|Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.
11283366|NCT02847858|EG001|Reported Event|Control Arm|Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.
11283367|NCT02848079|BG000|Baseline|Combined TAS-102 and TAS-OX|Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
11283368|NCT02848079|FG000|Participant Flow|Combined TAS-102 and TAS-OX|"Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion. In Part 1 treatments were started at level 1 doses, which were based on prior clinical experience with the medications studied. Dose escalation followed a traditional 3+3 design. The subjects in Part 2 were treated with dose level 3.~Oxaliplatin infusion was given on day 1 of each cycle. TAS-102 was taken twice daily on days 1-5 of each cycle."
11283369|NCT02848079|OG000|Outcome|Combined TAS-102 and TAS-OX|Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
11283370|NCT02848079|EG000|Reported Event|Combined TAS-102 and TAS-OX|Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
11283371|NCT02848222|BG000|Baseline|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283372|NCT02848222|BG001|Baseline|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
11283373|NCT02848222|BG002|Baseline|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283374|NCT02848222|BG003|Baseline|Total|Total of all reporting groups
11283375|NCT02848222|FG000|Participant Flow|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283376|NCT02848222|FG001|Participant Flow|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
11283377|NCT02848222|FG002|Participant Flow|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283378|NCT02848222|OG000|Outcome|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283379|NCT02848222|OG001|Outcome|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
11283380|NCT02848222|OG002|Outcome|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
10970604|NCT00911157|OG000|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
11283381|NCT02848222|EG000|Reported Event|Group 1: Twice Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283382|NCT02848222|EG001|Reported Event|Group 2: Once Daily Application of Bruder Compress|Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
11283383|NCT02848222|EG002|Reported Event|Group 3: Twice Daily Application of Warm Washcloth|Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
11283384|NCT02848313|BG000|Baseline|High-Risk Drusen (HRD)|The HRD cohort was defined as the presence of either at least 1 large (≥125 μm) druse or multiple medium-size (63-124 μm) drusen in one eye. Subjects had to have 1 eye with intermediate AMD (high-risk drusen [HRD] without geographic atrophy [GA]).
11283385|NCT02848313|BG001|Baseline|NCGA (Noncentral GA)|The NCGA cohort was defined as evidence of GA with cumulative area ≥1.27 mm2 (approximately 0.5 disc area) by fundus autofluorescence (FAF) that spared the fovea (defined as retinal pigment epithelium and outer retina intact by spectral-domain optical coherence tomography [SD-OCT]). Subjects had to have 1 eye with intermediate AMD with noncentral GA [NCGA]
11283386|NCT02848313|BG002|Baseline|Total|Total of all reporting groups
11283387|NCT02848313|FG000|Participant Flow|High-Risk Drusen (HRD)|The HRD cohort was defined as the presence of either at least 1 large (≥125 μm) druse or multiple medium-size (63-124 μm) drusen in one eye. Subjects had to have 1 eye with intermediate AMD (high-risk drusen [HRD] without geographic atrophy [GA]).
11283388|NCT02848313|FG001|Participant Flow|NCGA (Noncentral GA)|The NCGA cohort was defined as evidence of GA with cumulative area ≥1.27 mm2 (approximately 0.5 disc area) by fundus autofluorescence (FAF) that spared the fovea (defined as retinal pigment epithelium and outer retina intact by spectral-domain optical coherence tomography [SD-OCT]). Subjects had to have 1 eye with intermediate AMD with noncentral GA [NCGA]
11283389|NCT02848313|OG000|Outcome|AMD-High-Risk Drusen (HRD)|The HRD cohort was defined as the presence of either at least 1 large (≥125 μm) druse or multiple medium-size (63-124 μm) drusen in one eye. Subjects had to have 1 eye with intermediate AMD (high-risk drusen [HRD] without geographic atrophy [GA]).
11283390|NCT02848313|OG001|Outcome|AMD-NCGA (Noncentral GA)|The NCGA cohort was defined as evidence of GA with cumulative area ≥1.27 mm2 (approximately 0.5 disc area) by fundus autofluorescence (FAF) that spared the fovea (defined as retinal pigment epithelium and outer retina intact by spectral-domain optical coherence tomography [SD-OCT]). Subjects had to have 1 eye with intermediate AMD with noncentral GA [NCGA]
11283391|NCT02848313|EG000|Reported Event|High-Risk Drusen (HRD)|The HRD cohort was defined as the presence of either at least 1 large (≥125 μm) druse or multiple medium-size (63-124 μm) drusen in one eye. Subjects had to have 1 eye with intermediate AMD (high-risk drusen [HRD] without geographic atrophy [GA]).
11283392|NCT02848313|EG001|Reported Event|NCGA (Noncentral GA)|The NCGA cohort was defined as evidence of GA with cumulative area ≥1.27 mm2 (approximately 0.5 disc area) by fundus autofluorescence (FAF) that spared the fovea (defined as retinal pigment epithelium and outer retina intact by spectral-domain optical coherence tomography [SD-OCT]). Subjects had to have 1 eye with intermediate AMD with noncentral GA [NCGA]
11283393|NCT02848326|BG000|Baseline|Placebo|Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
11283394|NCT02848326|BG001|Baseline|Atogepant 10 mg QD|Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283395|NCT02848326|BG002|Baseline|Atogepant 30 mg QD|Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283396|NCT02848326|BG003|Baseline|Atogepant 60 mg QD|Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
11283397|NCT02848326|BG004|Baseline|Atogepant 30 mg BID|Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283398|NCT02848326|BG005|Baseline|Atogepant 60 mg BID|Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283399|NCT02848326|BG006|Baseline|Total|Total of all reporting groups
11283400|NCT02848326|FG000|Participant Flow|Placebo|Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
10970605|NCT00911157|OG001|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
11283401|NCT02848326|FG001|Participant Flow|Atogepant 10 mg QD|Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283402|NCT02848326|FG002|Participant Flow|Atogepant 30 mg QD|Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283403|NCT02848326|FG003|Participant Flow|Atogepant 60 mg QD|Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
11283404|NCT02848326|FG004|Participant Flow|Atogepant 30 mg BID|Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283405|NCT02848326|FG005|Participant Flow|Atogepant 60 mg BID|Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283406|NCT02848326|OG000|Outcome|Placebo|Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
11283407|NCT02848326|OG001|Outcome|Atogepant 10 mg QD|Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283408|NCT02848326|OG002|Outcome|Atogepant 30 mg QD|Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283409|NCT02848326|OG003|Outcome|Atogepant 60 mg QD|Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
11283410|NCT02848326|OG004|Outcome|Atogepant 30 mg BID|Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283411|NCT02848326|OG005|Outcome|Atogepant 60 mg BID|Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283412|NCT02848326|EG000|Reported Event|Placebo|Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks.
11283413|NCT02848326|EG001|Reported Event|Atogepant 10 mg QD|Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283414|NCT02848326|EG002|Reported Event|Atogepant 30 mg QD|Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
11283415|NCT02848326|EG003|Reported Event|Atogepant 60 mg QD|Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
11283416|NCT02848326|EG004|Reported Event|Atogepant 30 mg BID|Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283417|NCT02848326|EG005|Reported Event|Atogepant 60 mg BID|Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
11283418|NCT02848599|BG000|Baseline|Morphine|"The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery~morphine"
11283419|NCT02848599|BG001|Baseline|Levobupivacaine|"Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).~levobupivacaine"
11283420|NCT02848599|BG002|Baseline|Total|Total of all reporting groups
11283421|NCT02848599|FG000|Participant Flow|Morphine|"The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery~morphine"
11283422|NCT02848599|FG001|Participant Flow|Levobupivacaine|"Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).~levobupivacaine"
11283423|NCT02848599|OG000|Outcome|Morphine|"The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery~morphine"
11283424|NCT02848599|OG001|Outcome|Levobupivacaine|"Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).~levobupivacaine"
11283425|NCT02848599|OG000|Outcome|Morphine|35 participants who received morphine iv
11283426|NCT02848599|OG001|Outcome|Levobupivacaine|35 participants who received 0,125% levobupivacaine epiduraly
11283427|NCT02848599|EG000|Reported Event|Morphine|"The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery~morphine"
11283428|NCT02848599|EG001|Reported Event|Levobupivacaine|"Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).~levobupivacaine"
11283429|NCT02848651|BG000|Baseline|Atezolizumab|Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
11283430|NCT02848651|FG000|Participant Flow|Atezolizumab|Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
11283431|NCT02848651|OG000|Outcome|Atezolizumab|Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
11283432|NCT02848651|OG000|Outcome|bTMB Low (<16)|Blood tumor mutational burdern (bTMB) Low (<16)
11283433|NCT02848651|OG001|Outcome|bTMB High (>=16)|Blood tumor mutational burden (bTMB) High (>=16)
11283434|NCT02848651|OG000|Outcome|bTMB <10|Blood tumor mutational burden (bTMB) <10.
11283435|NCT02848651|OG001|Outcome|bTMB >=10|Blood tumor mutational burden (bTMb) >=10.
11283436|NCT02848651|OG002|Outcome|bTMB <16|Blood tumor mutational burden (bTMB) <16.
11283437|NCT02848651|OG003|Outcome|bTMB >=16|Blood tumor mutational burden (bTMB) >=16.
11283438|NCT02848651|OG004|Outcome|bTMB <20|Blood tumor mutational burden (bTMB) <20.
11092420|NCT01539759|FG001|Participant Flow|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
11283439|NCT02848651|OG005|Outcome|bTMB >=20|Blood tumor mutational burden (bTMB) >=20.
11283440|NCT02848651|OG000|Outcome|bTMB <16|Blood tumor mutational burden (bTMB) <16.
11283441|NCT02848651|OG001|Outcome|bTMB >=16|Blood tumor mutational burden (bTMB) >=16.
11283442|NCT02848651|OG002|Outcome|bTMB <20|Blood tumor mutational burden (bTMB) <20
11283443|NCT02848651|OG003|Outcome|bTMB >=20|Blood tumor mutational burden (bTMB) >=20.
11283444|NCT02848651|OG001|Outcome|bTMB >=10|Blood tumor mutational burden (bTMB) >=10.
11283445|NCT02848651|OG002|Outcome|bTMB <16|Blood tumor mutational burdern (bTMB) <16.
11283446|NCT02848651|OG004|Outcome|bTMF <20|Blood tumor mutational burden (bTMB) <20.
11283447|NCT02848651|OG005|Outcome|bTMF >=20|Blood tumor mutational burden (bTMB) >=20.
11283448|NCT02848651|EG000|Reported Event|Atezolizumab|Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
11283449|NCT02848664|BG000|Baseline|Laryngeal Vibrotactile Stimulation|"Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.~Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia"
11283450|NCT02848664|FG000|Participant Flow|Laryngeal Vibrotactile Stimulation|Participants with dysphagia received an external laryngeal vibratory stimulation device, The Passy Muir Swallowing Self Trainer, to assist with swallowing retraining. Participants and their caregivers received training to criterion on how to use the device and were then given a device to take home for 3 months for daily use in swallowing training and for saliva swallowing throughout the day. They were asked to use the device for a minimum of 60 practice trials of swallowing their own and to wear the device to assist with saliva swallowing. All participants were evaluated on their swallowing using modified barium swallow examination and patient questionnaires immediately before device training and on return 3 months later. They also completed questionnaires on the device characteristics on return.
11283451|NCT02848664|OG000|Outcome|Laryngeal Vibrotactile Stimulation|"Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.~Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia"
11283452|NCT02848664|OG000|Outcome|Laryngeal Vibrotactile Stimulation|Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing
11283453|NCT02848664|OG000|Outcome|Laryngeal Vibrotactile Stimulation|Patients using vibrotactile device over 3 months at home while practicing swallowing and to manage salivary flow by swallowing during waking hours
11283454|NCT02848664|OG000|Outcome|Baseline Before Device Use|Baseline evaluation before receiving a device
11283455|NCT02848664|OG001|Outcome|After Device Use for 3 Months|After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours
11283456|NCT02848664|EG000|Reported Event|Laryngeal Vibrotactile Stimulation|Patients using vibrotactile device over 3 months at home while practicing swallowing and to manage salivary by swallowing during waking hours
11283457|NCT02848729|BG000|Baseline|Oral Acetaminophen|Treatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an IV infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283458|NCT02848729|BG001|Baseline|IV Acetaminophen|Treatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283459|NCT02848729|BG002|Baseline|Total|Total of all reporting groups
11283460|NCT02848729|FG000|Participant Flow|Oral Acetaminophen|Treatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an intravenous (IV) infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283461|NCT02848729|FG001|Participant Flow|IV Acetaminophen|Treatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283462|NCT02848729|OG000|Outcome|First Dose - Before Morphine Co-administration|AUC6 for acetaminophen before morphine co-administration (hours -6 to -1)
11283463|NCT02848729|OG001|Outcome|Second Dose - During Morphine Co-administration|AUC6 for acetaminophen during morphine co-administration (hours 0 to 6)
11283464|NCT02848729|OG002|Outcome|Third Dose - During Morphine Co-administration|AUC6 for acetaminophen during morphine co-administration (hours 6 to 12)
11283465|NCT02848729|OG003|Outcome|Fourth Dose - After Morphine Co-administration|AUC6 for acetaminophen after morphine co-administration (hours 12 to 18)
11283466|NCT02848729|OG000|Outcome|After First Dose of Morphine Co-administration|AUC18 after first dose of morphine co-administration (hours 0-18)
11283467|NCT02848729|OG000|Outcome|First Dose - Before Morphine Co-administration|Pharmacokinetics of oral acetaminophen before morphine co-administration (hours -6 to -1)
11283468|NCT02848729|OG001|Outcome|Second Dose - During Morphine Co-administration|Pharmacokinetics of oral acetaminophen during morphine co-administration (hours 0 to 6)
11283469|NCT02848729|OG002|Outcome|Third Dose - During Morphine Co-administration|Pharmacokinetics of oral acetaminophen during morphine co-administration (hours 6 to 12)
10820429|NCT00057876|FG000|Participant Flow|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
11092421|NCT01539759|OG000|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
11215114|NCT02296502|EG002|Reported Event|Autism Spectrum Disorder (DSM IV Only)|All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5
11215115|NCT02296502|EG003|Reported Event|Non-Autism Spectrum Disorder|All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.
11215116|NCT02296606|BG000|Baseline|All Participants|
11215117|NCT02296606|FG000|Participant Flow|All Participants|All participants underwent three pupil exams, two by flashlight/pen light by two different assessors, and one by a researcher using the Pupillometer Device. Pupil exams occurred up to three times daily for the extent that the patient was in the ICU at the enrolling hospital.
11215118|NCT02296606|OG000|Outcome|All Participants|There are no groups/arms for the purpose of this study.
11215119|NCT02296606|EG000|Reported Event|All Participants|There are no groups/arms for the purpose of this study.
11215120|NCT02296775|BG000|Baseline|DRL- Rituximab-DRL_RI|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215121|NCT02296775|BG001|Baseline|Rituxan® (US Licensed Reference Product): RP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215122|NCT02296775|BG002|Baseline|MabThera® (EU Approved Reference Medicinal Product): RMP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215123|NCT02296775|BG003|Baseline|Total|Total of all reporting groups
11215124|NCT02296775|FG000|Participant Flow|DRL_RI (DRL Rituximab-Test Product Arm)|"DRL_RI 500 mg/50 mL solution in a single-use vial.~On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15."
11215125|NCT02296775|FG001|Participant Flow|Rituxan® (US Licensed Reference Product)|Rituxan® 500 mg/50 mL solution in a single-use vial. On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15.
11215126|NCT02296775|FG002|Participant Flow|MabThera® (EU Approved Reference Medicinal Product)|"MabThera® 500 mg/50 mL solution in a single-use vial.~On Day 1, all randomized patients were received one dose of 1000 mg of assigned study drug as a slow IV infusion. The second infusion was administered on Day 15."
11215127|NCT02296775|OG000|Outcome|DRL- Rituximab-DRL_RI|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215128|NCT02296775|OG001|Outcome|Rituxan® (US Licensed Reference Product): RP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215129|NCT02296775|OG002|Outcome|MabThera® (EU Approved Reference Medicinal Product): RMP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215130|NCT02296775|EG000|Reported Event|DRL- Rituximab-DRL_RI|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215131|NCT02296775|EG001|Reported Event|Rituxan® (US Licensed Reference Product): RP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215132|NCT02296775|EG002|Reported Event|MabThera® (EU Approved Reference Medicinal Product): RMP|On successful completion of the screening period, patients were randomized to 1 of the 3 treatment arms (DRL_RI, Rituxan®, or MabThera®) and administered 1000 mg of the study drug, one each on Day 1 and Day 15, while continuing their individual background stabilized DMARD regimen.
11215133|NCT02296840|BG000|Baseline|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
11215134|NCT02296840|BG001|Baseline|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
11283470|NCT02848729|OG003|Outcome|Fourth Dose - After Morphine Co-administration|Pharmacokinetics of oral acetaminophen during morphine co-administration (hours 12 to 18)
11283471|NCT02848729|EG000|Reported Event|Oral Acetaminophen|Treatment A = 4 repeat doses of 1,000 mg oral acetaminophen (2 x 500 mg tablets) and an IV infusion of saline every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283472|NCT02848729|EG001|Reported Event|IV Acetaminophen|Treatment B = 4 repeat doses of IV acetaminophen (1,000 mg/100 mL) and 2 placebo tablets every 6 hours (Hours -6, 0, 6, and 12), and 2 infusions of IV morphine (0.125 mg/kg) at Hours 0 and 6.
11283473|NCT02848833|BG000|Baseline|JARDIANCE®|JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
11283474|NCT02848833|FG000|Participant Flow|JARDIANCE®|JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
11283475|NCT02848833|OG000|Outcome|JARDIANCE®|JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
11283476|NCT02848833|EG000|Reported Event|JARDIANCE®|JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
11283477|NCT02849080|BG000|Baseline|Oral Semaglutide Flex|Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.
11283478|NCT02849080|BG001|Baseline|Sitagliptin 100 mg|Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants who were still on treatment at week 52 were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.
11283479|NCT02849080|BG002|Baseline|Total|Total of all reporting groups
11283480|NCT02849080|FG000|Participant Flow|Oral Semaglutide Flex|Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.
11283481|NCT02849080|FG001|Participant Flow|Sitagliptin 100 mg- Main Phase|Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
11283482|NCT02849080|FG002|Participant Flow|Oral Semaglutide Flex- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283483|NCT02849080|FG003|Participant Flow|Sitagliptin 100 mg- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283484|NCT02849080|OG000|Outcome|Oral Semaglutide Flex- Main Phase|Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
11215135|NCT02296840|BG002|Baseline|Total|Total of all reporting groups
11215136|NCT02296840|FG000|Participant Flow|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
11215137|NCT02296840|FG001|Participant Flow|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
11215138|NCT02296840|OG000|Outcome|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
11215139|NCT02296840|OG001|Outcome|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
11215140|NCT02296840|EG000|Reported Event|Ibuprofen|Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
11215141|NCT02296840|EG001|Reported Event|Hydrocodone-acetaminophen|Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
11215142|NCT02296853|BG000|Baseline|Severe Hepatic Impairment Group|Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1.
11215143|NCT02296853|BG001|Baseline|Matched Normal Hepatic Function Group|Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1.
11215144|NCT02296853|BG002|Baseline|Total|Total of all reporting groups
11215145|NCT02296853|FG000|Participant Flow|Severe Hepatic Impairment Group|Participants with severe hepatic impairment received a single oral dose of tenofovir alafenamide (TAF) 25 mg on Day 1.
11215146|NCT02296853|FG001|Participant Flow|Matched Normal Hepatic Function Group|Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1.
11215147|NCT02296853|OG000|Outcome|Severe Hepatic Impairment Group|Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1.
11215148|NCT02296853|OG001|Outcome|Matched Normal Hepatic Function Group|Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1.
11215149|NCT02296853|EG000|Reported Event|Severe Hepatic Impairment Group|Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1.
11215150|NCT02296853|EG001|Reported Event|Matched Normal Hepatic Function Group|Participants with normal hepatic function received a single oral dose of TAF 25 mg of on Day 1.
11215151|NCT02296892|BG000|Baseline|Remimazolam|Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11215152|NCT02296892|BG001|Baseline|Placebo|Placebo iv as inactive control arm
11215153|NCT02296892|BG002|Baseline|Midazolam|Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
11215154|NCT02296892|BG003|Baseline|Total|Total of all reporting groups
11215155|NCT02296892|FG000|Participant Flow|Remimazolam|Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11215156|NCT02296892|FG001|Participant Flow|Placebo|Placebo iv as inactive control arm
11215157|NCT02296892|FG002|Participant Flow|Midazolam|Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
11215158|NCT02296892|OG000|Outcome|Remimazolam|Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11215159|NCT02296892|OG001|Outcome|Placebo|Placebo iv as inactive control arm
11215160|NCT02296892|OG002|Outcome|Midazolam|Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
11215161|NCT02296892|EG000|Reported Event|Remimazolam|Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
11215162|NCT02296892|EG001|Reported Event|Placebo|Placebo iv as inactive control arm
11215163|NCT02296892|EG002|Reported Event|Midazolam|Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
11215164|NCT02296931|BG000|Baseline|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
11215165|NCT02296931|BG001|Baseline|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
11215166|NCT02296931|BG002|Baseline|Total|Total of all reporting groups
11215167|NCT02296931|FG000|Participant Flow|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
11215168|NCT02296931|FG001|Participant Flow|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
11215169|NCT02296931|OG000|Outcome|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
11215170|NCT02296931|OG001|Outcome|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
11215171|NCT02296931|EG000|Reported Event|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
11215172|NCT02296931|EG001|Reported Event|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
11283485|NCT02849080|OG001|Outcome|Sitagliptin 100 mg- Main Phase|Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
11283486|NCT02849080|OG000|Outcome|Oral Semaglutide Flex- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283487|NCT02849080|OG001|Outcome|Sitagliptin 100 mg- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283488|NCT02849080|OG000|Outcome|Oral Semaglutide Flex- Sustainability|Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104).
11283489|NCT02849080|EG000|Reported Event|Oral Semaglutide Flex- Main Phase|Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
11283490|NCT02849080|EG001|Reported Event|Sitagliptin 100 mg- Main Phase|Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
11283491|NCT02849080|EG002|Reported Event|Oral Semaglutide Flex- Sustainability|Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104).
11283492|NCT02849080|EG003|Reported Event|Oral Semaglutide Flex- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283493|NCT02849080|EG004|Reported Event|Sitagliptin 100 mg- Switch|Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
11283494|NCT02849184|BG000|Baseline|Suvorexant|"Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks~suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime."
11283495|NCT02849184|BG001|Baseline|Placebo|"Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.~Placebo: Placebo once daily before bedtime."
11283496|NCT02849184|BG002|Baseline|Total|Total of all reporting groups
11283497|NCT02849184|FG000|Participant Flow|Suvorexant|"Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks~suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime."
11283498|NCT02849184|FG001|Participant Flow|Placebo|"Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.~Placebo: Placebo once daily before bedtime."
11283499|NCT02849184|OG000|Outcome|Suvorexant|"Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks~suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime."
11283500|NCT02849184|OG001|Outcome|Placebo|"Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.~Placebo: Placebo once daily before bedtime."
11283501|NCT02849184|EG000|Reported Event|Suvorexant|"Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks~suvorexant: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime."
11283502|NCT02849184|EG001|Reported Event|Placebo|"Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.~Placebo: Placebo once daily before bedtime."
11283503|NCT02849418|BG000|Baseline|Placebo|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.
11283504|NCT02849418|BG001|Baseline|GSK1358820 200U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.
11283505|NCT02849418|BG002|Baseline|Total|Total of all reporting groups
11283506|NCT02849418|FG000|Participant Flow|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 milliliter [mL] each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283507|NCT02849418|FG001|Participant Flow|Treatment Cycle 1: GSK1358820 200U|Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283508|NCT02849418|FG002|Participant Flow|Treatment Cycle 2: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).
11283509|NCT02849418|FG003|Participant Flow|Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).
11283510|NCT02849418|FG004|Participant Flow|Treatment Cycle 3: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283511|NCT02849418|FG005|Participant Flow|Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283512|NCT02849418|OG000|Outcome|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283513|NCT02849418|OG001|Outcome|Treatment Cycle 1: GSK1358820 200U|Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283514|NCT02849418|OG000|Outcome|Treatment Cycle 2: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).
11283515|NCT02849418|OG001|Outcome|Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).
11283516|NCT02849418|OG000|Outcome|Treatment Cycle 3: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283517|NCT02849418|OG001|Outcome|Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283518|NCT02849418|OG000|Outcome|Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).
11283519|NCT02849418|OG000|Outcome|Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283520|NCT02849418|EG000|Reported Event|Treatment Cycle 1: Placebo|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283521|NCT02849418|EG001|Reported Event|Treatment Cycle 1: GSK1358820 200U|Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
11283522|NCT02849418|EG002|Reported Event|Treatment Cycle 2: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).
11283523|NCT02849418|EG003|Reported Event|Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).
11283524|NCT02849418|EG004|Reported Event|Treatment Cycle 3: Placebo / GSK1358820 200 U|Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283525|NCT02849418|EG005|Reported Event|Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U|Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
11283526|NCT02849509|BG000|Baseline|Cohort A (Switch Patients - Pradaxa)|Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.
11283527|NCT02849509|BG001|Baseline|Cohort B (New Patients - Pradaxa)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa
11283528|NCT02849509|BG002|Baseline|Cohort B (New Patients - VKA)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11283529|NCT02849509|BG003|Baseline|Total|Total of all reporting groups
11283530|NCT02849509|FG000|Participant Flow|Cohort A (Switch Patients - Pradaxa)|Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.
11283531|NCT02849509|FG001|Participant Flow|Cohort B (New Patients - Pradaxa)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa
11283532|NCT02849509|FG002|Participant Flow|Cohort B (New Patients - VKA)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11283533|NCT02849509|OG000|Outcome|Cohort A (Switch Patients - Pradaxa)|Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.
11283534|NCT02849509|OG000|Outcome|Cohort B (New Patients - Pradaxa)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa
11283535|NCT02849509|OG001|Outcome|Cohort B (New Patients - VKA)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11283536|NCT02849509|OG001|Outcome|Cohort B (New Patients - Pradaxa)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa
11283537|NCT02849509|OG002|Outcome|Cohort B (New Patients - VKA)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11283538|NCT02849509|EG000|Reported Event|Cohort A (Switch Patients - Pradaxa)|Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.
11283539|NCT02849509|EG001|Reported Event|Cohort B (New Patients - Pradaxa)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa
11283540|NCT02849509|EG002|Reported Event|Cohort B (New Patients - VKA)|Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
11337698|NCT03591146|EG000|Reported Event|TLC590 190mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11283541|NCT02849678|BG000|Baseline|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
11283542|NCT02849678|BG001|Baseline|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
11283543|NCT02849678|BG002|Baseline|Total|Total of all reporting groups
11283544|NCT02849678|FG000|Participant Flow|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
11283545|NCT02849678|FG001|Participant Flow|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
11283546|NCT02849678|OG000|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
11283547|NCT02849678|OG001|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
11283548|NCT02849678|EG000|Reported Event|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
11283549|NCT02849678|EG001|Reported Event|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
11283550|NCT02849704|BG000|Baseline|Chronic Pancreatitis (CP) Subjects|CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.
11283551|NCT02849704|BG001|Baseline|Healthy Controls|Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
11283552|NCT02849704|BG002|Baseline|Total|Total of all reporting groups
11283553|NCT02849704|FG000|Participant Flow|Chronic Pancreatitis (CP) Subjects|CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.
11283554|NCT02849704|FG001|Participant Flow|Healthy Controls|Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
11283555|NCT02849704|OG000|Outcome|Chronic Pancreatitis (CP) Subjects|CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.
11283556|NCT02849704|OG001|Outcome|Healthy Controls|Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
11283557|NCT02849704|OG000|Outcome|Chronic Pancreatitis (CP) Subjects|As part of the primary assessment, CP subjects will eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, and collect stool over 72 hours.
11283558|NCT02849704|OG001|Outcome|Healthy Controls|Healthy controls will eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, and collect stool over 72 hours.
11283559|NCT02849704|OG000|Outcome|Chronic Pancreatitis (CP) Subjects|"For Visit 1, CP subjects will eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, and collect stool over 72 hours.~Subjects will take Creon36™ for 9 days at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2 and the day of Visit 2.~Visit 2 will repeat Visit 1 study procedures."
11283560|NCT02849704|OG000|Outcome|Chronic Pancreatitis (CP) Subjects|"For Visit 1, CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn prior to MBT breakfast consumption and each hour for 8 hours after consumption, and consume a low-fat study lunch at hour 6 during the test.~Subjects will take Creon36™ for 9 days at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2 and the day of Visit 2.~Visit 2 will repeat Visit 1 study procedures."
11283561|NCT02849704|EG000|Reported Event|Chronic Pancreatitis (CP) Subjects|CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.
11283562|NCT02849704|EG001|Reported Event|Healthy Controls|Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
11283563|NCT02849938|BG000|Baseline|Control Group|Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
11283564|NCT02849938|BG001|Baseline|Telemedicine Group|"Received the TytoCare Device in addition to usual care.~TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment."
11283565|NCT02849938|BG002|Baseline|Total|Total of all reporting groups
11283566|NCT02849938|FG000|Participant Flow|Control Group|Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
11283567|NCT02849938|FG001|Participant Flow|Telemedicine Group|"Received the TytoCare Device in addition to usual care.~TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment."
11283568|NCT02849938|OG000|Outcome|Control Group|Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
11283569|NCT02849938|OG001|Outcome|Telemedicine Group|"Received the TytoCare Device in addition to usual care.~TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment."
11283570|NCT02849938|EG000|Reported Event|Control Group|Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation.
11283571|NCT02849938|EG001|Reported Event|Telemedicine Group|"Received the TytoCare Device in addition to usual care.~TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment."
11283572|NCT02850068|BG000|Baseline|Geniculate Artery Embolization|"Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).~Geniculate Artery Embolization: Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA."
11283573|NCT02850068|FG000|Participant Flow|Geniculate Artery Embolization|"Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).~Geniculate Artery Embolization: Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA."
11337699|NCT03591146|EG001|Reported Event|TLC590 380mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11283574|NCT02850068|OG000|Outcome|Geniculate Artery Embolization|"Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).~Geniculate Artery Embolization: Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA."
11283575|NCT02850068|EG000|Reported Event|Geniculate Artery Embolization|"Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).~Geniculate Artery Embolization: Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA."
11283576|NCT02850159|BG000|Baseline|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283577|NCT02850159|BG001|Baseline|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283578|NCT02850159|BG002|Baseline|Total|Total of all reporting groups
11283579|NCT02850159|FG000|Participant Flow|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283580|NCT02850159|FG001|Participant Flow|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283581|NCT02850159|OG000|Outcome|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283582|NCT02850159|OG001|Outcome|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283583|NCT02850159|EG000|Reported Event|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously~rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283584|NCT02850159|EG001|Reported Event|rTMS Group|"high-frequency rTMS and sham tDCS~rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
11283585|NCT02850276|BG000|Baseline|Pyridostigmine|30mg PO three times a day for 8 weeks
11283586|NCT02850276|FG000|Participant Flow|Pyridostigmine|30mg PO three times a day for 8 weeks
11283587|NCT02850276|OG000|Outcome|Pyridostigmine|30mg PO three times a day for 8 weeks
11283588|NCT02850276|OG000|Outcome|Pyridostigmine|30mg PO three times a day
11283589|NCT02850276|EG000|Reported Event|Pyridostigmine|30mg PO three times a day for 8 weeks
11283590|NCT02850601|BG000|Baseline|Dexamethasone Solution|"Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283591|NCT02850601|BG001|Baseline|Dexamethasone Solution in Mucolox™|"Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283592|NCT02850601|BG002|Baseline|Total|Total of all reporting groups
11283593|NCT02850601|FG000|Participant Flow|Dexamethasone Solution|"Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283594|NCT02850601|FG001|Participant Flow|Dexamethasone Solution in Mucolox™|"Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283595|NCT02850601|OG000|Outcome|Dexamethasone Rinses|12 subjects A four-week supply of dexamethasone solution (0.1mg/ml) was dispensed and subjects were instructed to swish for 5 minutes and expectorate with 5 mL of solution, three times a day, and to avoid eating or drinking for 15 minutes
11283596|NCT02850601|OG001|Outcome|Dexamethasone in Mucolox Rinses|12 subjects A four-week supply of dexamethasone in Mucolox at 0.1mg/ml was dispensed and subjects were instructed to swish for 5 minutes and expectorate with 5 mL of solution, three times a day, and to avoid eating or drinking for 15 minutes
11283597|NCT02850601|EG000|Reported Event|Dexamethasone Solution|"Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283598|NCT02850601|EG001|Reported Event|Dexamethasone Solution in Mucolox™|"Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks~Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate"
11283599|NCT02850965|BG000|Baseline|BI 695501|Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.
11283600|NCT02850965|BG001|Baseline|US-licensed Humira|Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.
11283601|NCT02850965|BG002|Baseline|Total|Total of all reporting groups
11283602|NCT02850965|FG000|Participant Flow|BI 695501|Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.
11283603|NCT02850965|FG001|Participant Flow|US-licensed Humira|Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.
11283604|NCT02850965|OG000|Outcome|BI 695501|Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.
11283605|NCT02850965|OG001|Outcome|US-licensed Humira|Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.
11283606|NCT02850965|EG000|Reported Event|BI 695501|Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.
11283607|NCT02850965|EG001|Reported Event|US-licensed Humira|Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.
11283608|NCT02850978|BG000|Baseline|Spiolto®|Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
11283609|NCT02850978|FG000|Participant Flow|Spiolto®|Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
11092422|NCT01539759|OG001|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
11283610|NCT02850978|OG000|Outcome|Spiolto®|Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
11283611|NCT02850978|EG000|Reported Event|Spiolto®|Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
11283612|NCT02851069|BG000|Baseline|ABBVIE REGIMEN ± Ribavirin (RBV)|ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
11283613|NCT02851069|FG000|Participant Flow|ABBVIE REGIMEN ± Ribavirin (RBV)|ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
11283614|NCT02851069|OG000|Outcome|ABBVIE REGIMEN ± Ribavirin (RBV)|ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks
11283615|NCT02851069|EG000|Reported Event|ABBVIE REGIMEN|ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
11283616|NCT02851069|EG001|Reported Event|ABBVIE REGIMEN Plus Ribavirin (RBV)|ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
11283617|NCT02851108|BG000|Baseline|AS-AQ-MB|"Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.~Methylene Blue: 50 patients will receive methylene blue"
11283618|NCT02851108|BG001|Baseline|AS-AQ-PQ|"Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).~Primaquine: 50 patients will receive primaquine"
11283619|NCT02851108|BG002|Baseline|Total|Total of all reporting groups
11283620|NCT02851108|FG000|Participant Flow|AS-AQ-MB|"Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.~Methylene Blue: 50 patients will receive methylene blue"
11283621|NCT02851108|FG001|Participant Flow|AS-AQ-PQ|"Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).~Primaquine: 50 patients will receive primaquine"
11283622|NCT02851108|OG000|Outcome|AS-AQ-MB|"Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.~Methylene Blue: 50 patients will receive methylene blue"
11283623|NCT02851108|OG001|Outcome|AS-AQ-PQ|"Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).~Primaquine: 50 patients will receive primaquine"
11283624|NCT02851108|EG000|Reported Event|AS-AQ-MB|"Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.~Methylene Blue: 50 patients will receive methylene blue"
11283625|NCT02851108|EG001|Reported Event|AS-AQ-PQ|"Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).~Primaquine: 50 patients will receive primaquine"
11283626|NCT02851615|BG000|Baseline|SCThrive|"SCThrive Intervention for Adolescents with SCD - 6 week self-management group~SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11283627|NCT02851615|BG001|Baseline|Attention Control|6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
11283628|NCT02851615|BG002|Baseline|Total|Total of all reporting groups
11283629|NCT02851615|FG000|Participant Flow|SCThrive|"SCThrive Intervention for Adolescents with SCD - 6 week self-management group~SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11283630|NCT02851615|FG001|Participant Flow|Attention Control|6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
11283631|NCT02851615|OG000|Outcome|SCThrive|"SCThrive Intervention for Adolescents with SCD - 6 week self-management group~SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11283632|NCT02851615|OG001|Outcome|Attention Control|6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
11283633|NCT02851615|OG000|Outcome|SCThrive|SCThrive Intervention for Adolescents with SCD - 6-week self-management group
11283634|NCT02851615|EG000|Reported Event|SCThrive|"SCThrive Intervention for Adolescents with SCD - 6 week self-management group~SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program"
11283635|NCT02851615|EG001|Reported Event|Attention Control|6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
11283636|NCT02851823|BG000|Baseline|Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing|One side (left or right) of the mouth received Er:YAG+Nd:YAG laser therapy (test group) and other side received scaling and root planing with hand instruments (control group)
11283637|NCT02851823|FG000|Participant Flow|Combined Er:YAG and Nd:YAG Laser vs Scaling and Root Planing|"Combined Er:YAG and Nd:YAG Laser Application Left Side, Scaling and Root Planning Procedure Right Side and Scaling and Root Planning Procedure Left Side, Combined Er:YAG and Nd:YAG Laser Application Right Side"
11283638|NCT02851823|OG000|Outcome|Control Group|"Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.~Periodontal curettes"
11283639|NCT02851823|OG001|Outcome|Test Group|"Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxiﬁcation purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.~Er-YAG+Nd-YAG lasers"
11283640|NCT02851823|EG000|Reported Event|Control Group|"Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.~Periodontal curettes"
11283641|NCT02851823|EG001|Reported Event|Test Group|"Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxiﬁcation purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.~Er-YAG+Nd-YAG lasers"
11283642|NCT02852005|BG000|Baseline|Group 1: Boost|MVA/HIV62B mo(0,4) post HVTN 205 MMM
11283643|NCT02852005|BG001|Baseline|Group 2: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
11283644|NCT02852005|BG002|Baseline|Group 3: Boost|MVA/HIV62B mo(0,4) post HVTN 205 DDMM
11283645|NCT02852005|BG003|Baseline|Group 4: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283646|NCT02852005|BG004|Baseline|Group 5: Boost|AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283647|NCT02852005|BG005|Baseline|Total|Total of all reporting groups
11092423|NCT01539759|EG000|Reported Event|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
11283648|NCT02852005|FG000|Participant Flow|Group 1: Boost|MVA/HIV62B mo(0,4) post HVTN 205 MMM
11283649|NCT02852005|FG001|Participant Flow|Group 2: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
11283650|NCT02852005|FG002|Participant Flow|Group 3: Boost|MVA/HIV62B mo(0,4) post HVTN 205 DDMM
11283651|NCT02852005|FG003|Participant Flow|Group 4: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283652|NCT02852005|FG004|Participant Flow|Group 5: Boost|AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283653|NCT02852005|OG000|Outcome|Group 1: Boost|MVA/HIV62B mo(0,4) post HVTN 205 MMM
11283654|NCT02852005|OG001|Outcome|Group 2: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
11283655|NCT02852005|OG002|Outcome|Group 3: Boost|MVA/HIV62B mo(0,4) post HVTN 205 DDMM
11283656|NCT02852005|OG003|Outcome|Group 4: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283657|NCT02852005|OG004|Outcome|Group 5: Boost|AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283658|NCT02852005|OG005|Outcome|Group 6: Boost|MVA/HIV62B at mo(0,4)
11283659|NCT02852005|OG006|Outcome|Group 7: Boost|MVA/HIV62B + AIDSVAX B/E at mo(0,4)
11283660|NCT02852005|EG000|Reported Event|Group 1: Boost|MVA/HIV62B mo(0,4) post HVTN 205 MMM
11283661|NCT02852005|EG001|Reported Event|Group 2: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
11283662|NCT02852005|EG002|Reported Event|Group 3: Boost|MVA/HIV62B mo(0,4) post HVTN 205 DDMM
11283663|NCT02852005|EG003|Reported Event|Group 4: Boost|MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283664|NCT02852005|EG004|Reported Event|Group 5: Boost|AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
11283665|NCT02852265|BG000|Baseline|New Start COC Starters|Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
11283666|NCT02852265|BG001|Baseline|Continuing COC Users|Women who have been using a combined oral contraceptive for more than 4 weeks
11283667|NCT02852265|BG002|Baseline|Total|Total of all reporting groups
11283668|NCT02852265|FG000|Participant Flow|New Start COC Users|Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
11283669|NCT02852265|FG001|Participant Flow|Continuing COC Users|Women who have been using a combined oral contraceptive for more than 4 weeks
11283670|NCT02852265|OG000|Outcome|New Start COC Users|Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
11283671|NCT02852265|OG001|Outcome|Continuing COC Users|Women who have been using a combined oral contraceptive for more than 4 weeks
11283672|NCT02852265|OG000|Outcome|COC Users|Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users.
11283673|NCT02852265|OG001|Outcome|COC New Starts|Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women starting a COC or recently started a COC within the past month will be considered new starts.
11283674|NCT02852265|OG000|Outcome|COC Users|"Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users.~Etonogestrel contraceptive implant: Place nexplanon"
11283675|NCT02852265|OG001|Outcome|New Starts|"Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women starting a COC or recently started a COC within the past month will be considered new starts.~Etonogestrel contraceptive implant: Place nexplanon"
11283676|NCT02852265|EG000|Reported Event|New Start COC Users|Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
11283677|NCT02852265|EG001|Reported Event|Continuing COC Users|Women who have been using a combined oral contraceptive for more than 4 weeks
11283678|NCT02852330|BG000|Baseline|Voltage Tomography|"Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.~SA16 research software: Software for measurement of voltage tomography intraoperatively.~CS19 (1.6.2): Software for measurement of voltage tomography post-operatively."
11283679|NCT02852330|FG000|Participant Flow|Voltage Tomography|"Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.~SA16 research software: Software for measurement of voltage tomography intraoperatively.~CS19 (1.6.2): Software for measurement of voltage tomography post-operatively."
11283680|NCT02852330|OG000|Outcome|Voltage Tomography|"Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.~SA16 research software: Software for measurement of voltage tomography intraoperatively.~CS19 (1.6.2): Software for measurement of voltage tomography post-operatively."
11283681|NCT02852330|EG000|Reported Event|Voltage Tomography|"Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.~SA16 research software: Software for measurement of voltage tomography intraoperatively.~CS19 (1.6.2): Software for measurement of voltage tomography post-operatively."
11283682|NCT02852434|BG000|Baseline|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
11283683|NCT02852434|BG001|Baseline|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
11283684|NCT02852434|BG002|Baseline|Total|Total of all reporting groups
11283685|NCT02852434|FG000|Participant Flow|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
11283686|NCT02852434|FG001|Participant Flow|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
11283687|NCT02852434|OG000|Outcome|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
11283688|NCT02852434|OG001|Outcome|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
11283689|NCT02852434|EG000|Reported Event|Self-administered Gel|"Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure~Lidocaine Gel (2%)"
11283690|NCT02852434|EG001|Reported Event|Paracervical Block|"Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement~Lidocaine Paracervical Block (1%)"
11283691|NCT02853032|BG000|Baseline|Active rTMS to Right DLPFC|Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283692|NCT02853032|BG001|Baseline|Sham rTMS to the Right DLPFC|Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283693|NCT02853032|BG002|Baseline|Total|Total of all reporting groups
11283694|NCT02853032|FG000|Participant Flow|Active rTMS to Right DLPFC|Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283695|NCT02853032|FG001|Participant Flow|Sham rTMS to the Right DLPFC|Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283696|NCT02853032|OG000|Outcome|Active rTMS to Right DLPFC|Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283697|NCT02853032|OG001|Outcome|Sham rTMS to the Right DLPFC|Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283698|NCT02853032|OG000|Outcome|Active rTMS to the Right DLPFC|"Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 28 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week; 20 consecutive days.~Active repetitive transcranial magnetic stimulation: The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.~robotic arm: This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system w"
11283699|NCT02853032|OG001|Outcome|Sham rTMS to the Right DLPFC|"Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, sham rTMS will be delivered at 20 Hz in 2 sec trains with 28 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days.~robotic arm: This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.~Sham repetitive transcranial magnetic stimulation: The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment"
11283700|NCT02853032|EG000|Reported Event|Active rTMS to Right DLPFC|Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283701|NCT02853032|EG001|Reported Event|Sham rTMS to the Right DLPFC|Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
11283702|NCT02853123|BG000|Baseline|Total Subjects|This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
11283703|NCT02853123|FG000|Participant Flow|(Tiotropium 5 Microgram (μg))/(Tiotropium + Olodaterol 5/5 μg)|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283704|NCT02853123|FG001|Participant Flow|(Tiotropium + Olodaterol 5/5 μg)/(Tiotropium 5 μg)|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283705|NCT02853123|OG000|Outcome|Tiotropium 5 Microgram (μg)|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283706|NCT02853123|OG001|Outcome|Tiotropium + Olodaterol 5/5 μg|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283707|NCT02853123|EG000|Reported Event|Tiotropium 5 Microgram (μg)|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283708|NCT02853123|EG001|Reported Event|Tiotropium + Olodaterol 5/5 μg|Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
11283709|NCT02853123|EG002|Reported Event|Total Subjects|This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
11283710|NCT02853318|BG000|Baseline|Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)|"Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Cyclophosphamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11283711|NCT02853318|FG000|Participant Flow|Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)|"Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Cyclophosphamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11283712|NCT02853318|OG000|Outcome|Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)|"Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Cyclophosphamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11283713|NCT02853318|EG000|Reported Event|Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide)|"Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 and cyclophosphamide PO QD on days 1-21. Treatment repeats every 3 weeks for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients without evidence of disease progression may continue treatment in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Cyclophosphamide: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11283714|NCT02853435|BG000|Baseline|Total Participants-Part 1a|Participants received gepotidacin 1500 mg (3 x 500 mg) capsules, gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.
11283715|NCT02853435|BG001|Baseline|Total Participants-Part 2|Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in one of the 2 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.
11283716|NCT02853435|BG002|Baseline|Total Participants- Part 3|Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets - fed, gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed and gepotidacin 3000 mg (4 x 750 mg) RC tablets - fed orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.
11283717|NCT02853435|BG003|Baseline|Total|Total of all reporting groups
11283718|NCT02853435|FG000|Participant Flow|Gepotidacin-R Then Gepotidacin RC Then Gepotidacin HSWG|Participants received gepotidacin 1500 milligrams (mg) (3 x 500 mg) (Reference [R]) capsules in treatment period 1 followed by gepotidacin 1500 mg (2 x 750 mg) related RC tablets in treatment period 2 followed by gepotidacin 1500 mg (2 x 750 mg) high shear wet granulation (HSWG) tablets orally for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.
11283719|NCT02853435|FG001|Participant Flow|Gepotidacin HSWG Then Gepotidacin- R Then Gepotidacin RC|Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets in treatment period 1 followed by gepotidacin 1500 mg (3 x 500 mg) - R capsules in treatment Period 2 followed by gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 3 orally for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.
11283720|NCT02853435|FG002|Participant Flow|Gepotidacin-RC Then Gepotidacin HSWG Then Gepotidacin-R|Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 1 followed by gepotidacin 1500 mg (2 x 750 mg) HSWG tablets in treatment period 2 followed by gepotidacin 1500 mg (3 x 500 mg) - R capsules in treatment period 3 for 3 days in each treatment period in Part 1a. There was a washout period of at least 3 days between the doses.
11283721|NCT02853435|FG003|Participant Flow|Gepotidacin 1500 mg RC Then Gepotidacin 3000 mg RC|Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets in treatment period 1 followed by gepotidacin 3000 mg (4 x 750 mg) RC tablets in treatment period 2 orally for 3 days in each treatment period in Part 2. There was a washout period of at least 3 days between the doses.
11283722|NCT02853435|FG004|Participant Flow|Gepotidacin 1500 Then Gepotidacin 2250 Then Gepotidacin 3000|Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets - fed in treatment period 1 followed by Gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed in treatment period 2 followed by Gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed in treatment period 3 orally for 3 days in each treatment period in part 3. There was a washout period of at least 3 days between the doses.
11283723|NCT02853435|FG005|Participant Flow|Placebo Then Placebo Then Placebo|Participants received matching placebo to gepotidacin 1500 mg RC tablets in treatment period 1 followed by matching placebo to gepotidacin 2250 mg in treatment period 2 followed by matching placebo to gepotidacin 2250 mg RC tablets in treatment period 3 orally for 3 days in each treatment Period in Part 3. There was a washout period of at least 3 days between the doses.
11283724|NCT02853435|OG000|Outcome|Gepotidacin 1500 mg - R Capsules|Participants received gepotidacin 1500 (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.
11283725|NCT02853435|OG001|Outcome|Gepotidacin 1500 mg RC Tablets|Participants received gepotidacin 1500 (2 x 750) mg RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.
11283726|NCT02853435|OG002|Outcome|Gepotidacin 1500 mg HSWG Tablets|Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in Part 1a.
11283727|NCT02853435|OG000|Outcome|Gepotidacin 1500 mg RC Tablets-fasted|Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fasted state in one of the 2 treatment periods for 3 days in Part 1b.
11283728|NCT02853435|OG001|Outcome|Gepotidacin 3000 mg RC Tablets-fed|Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1b.
11283729|NCT02853435|OG000|Outcome|Gepotidacin RC 1500 mg Tablets|Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.
10822111|NCT00074490|OG003|Outcome|Arm IVB (6-day Expanded Th2 DLI)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11283730|NCT02853435|OG001|Outcome|Gepotidacin RC 3000 mg Tablets|Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
11283731|NCT02853435|OG001|Outcome|Gepotidacin RC 3000 mg Tablets|Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
11283732|NCT02853435|OG000|Outcome|Gepotidacin RC 1500 mg Tablets|Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets orally in Part 2 Period 1.
11283733|NCT02853435|OG001|Outcome|Gepotidacin RC 3000 mg Tablets|Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets orally in Part 2 Period 2
11283734|NCT02853435|OG000|Outcome|Gepotidacin RC 1500 mg Fed|Participants received a single dose gepotidacin 1500 mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.
11283735|NCT02853435|OG001|Outcome|Gepotidacin RC 2250 mg Fed|Participants received a single dose gepotidacin 2250 mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.
11283736|NCT02853435|OG002|Outcome|Gepotidacin RC 3000 mg Fed|Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
11283737|NCT02853435|OG002|Outcome|Gepotidacin 1500 mg HSWG Tablets|Participants received gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the three treatment periods in Part 1a.
11283738|NCT02853435|OG001|Outcome|Gepotidacin 3000 mg RC Tablets-fed|Participants received Gepotidacin 1500 mg (2 x 750 mg) RC tablets orally in the fed state in one of the 2 treatment periods for 3 days in Part 1a.
11283739|NCT02853435|OG000|Outcome|Gepotidacin RC 1500 mg Fed|Participants received a single dose gepotidacin 1500mg (2 x 750 mg) RC tablets in the fed state orally in Part 3 Period 1.
11283740|NCT02853435|OG001|Outcome|Gepotidacin RC 2250 mg Fed|Participants received a single dose gepotidacin 2250mg (3 x 750 mg) RC tablets in the fed state orally in Part 3 Period 2.
11283741|NCT02853435|OG002|Outcome|Gepotidacin RC 3000 mg Fed|Participants received a single dose gepotidacin 3000mg (4 x 750 mg) RC tablets in the fed state orally in Part 3 Period 3.
11283742|NCT02853435|OG003|Outcome|Placebo|Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
11283743|NCT02853435|EG000|Reported Event|Gepotidacin 1500 mg - R Capsules|Participants received gepotidacin 1500 mg (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a.
11283744|NCT02853435|EG001|Reported Event|Gepotidacin 1500 mg RC Tablets|Participants received gepotidacin 1500 mg (2 x 750) RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a.
11283745|NCT02853435|EG002|Reported Event|Gepotidacin 1500 mg HSWG Tablets|Participants received gepotidacin 1500 mg (2 x 750) HSWG tablets orally in one of the three treatment periods in Part 1a.
11283746|NCT02853435|EG003|Reported Event|Gepotidacin RC 1500 mg Tablets|Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
11283747|NCT02853435|EG004|Reported Event|Gepotidacin RC 3000 mg Tablets|Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2.
11283748|NCT02853435|EG005|Reported Event|Gepotidacin RC 1500 mg Fed|Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3.
11283749|NCT02853435|EG006|Reported Event|Gepotidacin RC 2250 mg Fed|Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3.
11283750|NCT02853435|EG007|Reported Event|Gepotidacin RC 3000 mg Fed|Participants received gepotidacin 3000 mg (4 x 750) RC tablets in the fed state in one of the 3 treatment periods in Part 3.
11283751|NCT02853435|EG008|Reported Event|Placebo|Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3.
11283752|NCT02853929|BG000|Baseline|dTpa Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283753|NCT02853929|BG001|Baseline|Control Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283754|NCT02853929|BG002|Baseline|Total|Total of all reporting groups
11283755|NCT02853929|FG000|Participant Flow|dTpa Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283756|NCT02853929|FG001|Participant Flow|Control Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283757|NCT02853929|OG000|Outcome|dTpa Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283758|NCT02853929|OG001|Outcome|Control Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283759|NCT02853929|EG000|Reported Event|dTpa Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283760|NCT02853929|EG001|Reported Event|Control Group|"This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure"
11283761|NCT02854059|BG000|Baseline|Treatment IdeS (0.25 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.
11283762|NCT02854059|BG001|Baseline|Treatment IdeS (0.50 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
11283763|NCT02854059|BG002|Baseline|Total|Total of all reporting groups
11283764|NCT02854059|FG000|Participant Flow|Treatment IdeS (0.25 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.
11283765|NCT02854059|FG001|Participant Flow|IdeS (0.50 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
11283766|NCT02854059|OG000|Outcome|Treatment IdeS (0.25 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.
11283767|NCT02854059|OG001|Outcome|Treatment IdeS (0.50 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
11283768|NCT02854059|EG000|Reported Event|Treatment IdeS (0.25 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients.
11283769|NCT02854059|EG001|Reported Event|Treatment IdeS (0.50 mg/kg)|A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg).
11283770|NCT02854527|BG000|Baseline|ABECD (R1->R2->T->R3->R4)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (reference 1 or R1). Second, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Third, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fourth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fifth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283771|NCT02854527|BG001|Baseline|AEBDC (R1->T->R2->R4->R3)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (reference 1 or R1). Second, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Third, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fourth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fifth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283772|NCT02854527|BG002|Baseline|BACED (R2->R1->R3->T->R4)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (reference 2 or R2). Second, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Third, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fourth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fifth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283773|NCT02854527|BG003|Baseline|BCADE (R2->R3->R1->R4->T)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Second, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Third, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fourth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fifth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin.~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11337700|NCT03591146|EG002|Reported Event|TL590 570mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11337701|NCT03591146|EG003|Reported Event|TLC590 475mg|"TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.~TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension"
11283774|NCT02854527|BG004|Baseline|CBDAE (R3->R2->R4->R1->T)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Second, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Third, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fourth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fifth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin.~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283775|NCT02854527|BG005|Baseline|CDBEA (R3->R4->R2->T->R1)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Second, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Third, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fourth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fifth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283776|NCT02854527|BG006|Baseline|DCEBA (R4->R3->T->R2->R1)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Second, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Third, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fourth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fifth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283777|NCT02854527|BG007|Baseline|DECAB (R4->T->R3->R1->R2)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Second, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Third, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fourth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fifth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283778|NCT02854527|BG008|Baseline|EADBC (T->R1->R4->R2->R3)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Second, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Third, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fourth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fifth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283779|NCT02854527|BG009|Baseline|EDACB (T->R4->R1->R3->R2)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Second, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Third, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fourth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fifth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283780|NCT02854527|BG010|Baseline|Total|Total of all reporting groups
11283781|NCT02854527|FG000|Participant Flow|ABECD (R1->R2->T->R3->R4)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (reference 1 or R1). Second, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Third, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fourth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fifth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11287159|NCT02898662|EG000|Reported Event|AZD1419|Participants received AZD1419 for inhalation via nebuliser solution (up to 13 doses). All participants received 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of AZD1419 on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving AZD1419 dose 10.
11283782|NCT02854527|FG001|Participant Flow|AEBDC (R1->T->R2->R4->R3)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (reference 1 or R1). Second, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Third, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fourth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fifth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283783|NCT02854527|FG002|Participant Flow|BACED (R2->R1->R3->T->R4)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (reference 2 or R2). Second, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Third, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fourth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fifth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283784|NCT02854527|FG003|Participant Flow|BCADE (R2->R3->R1->R4->T)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Second, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Third, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fourth, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fifth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin.~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283785|NCT02854527|FG004|Participant Flow|CBDAE (R3->R2->R4->R1->T)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Second, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Third, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fourth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fifth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin.~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283786|NCT02854527|FG005|Participant Flow|CDBEA (R3->R4->R2->T->R1)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Second, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Third, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fourth, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fifth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283787|NCT02854527|FG006|Participant Flow|DCEBA (R4->R3->T->R2->R1)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Second, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Third, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Fourth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fifth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283788|NCT02854527|FG007|Participant Flow|DECAB (R4->T->R3->R1->R2)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Second, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Third, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fourth, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fifth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11092424|NCT01539759|EG001|Reported Event|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
11092425|NCT01539837|BG000|Baseline|Placebo|Feriprox placebo administered orally at the same dosing volume as the 20mg/kg/day feriprox per day
11092426|NCT01539837|BG001|Baseline|Deferiprone 20mg|20mg/kg/day deferiprone divided into two equal doses (morning and evening), every day for 6 months
11283789|NCT02854527|FG008|Participant Flow|EADBC (T->R1->R4->R2->R3)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Second, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Third, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Fourth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2). Fifth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283790|NCT02854527|FG009|Participant Flow|EDACB (T->R4->R1->R3->R2)|"Subjects in this sequence were administered five different treatments in a sequence with a washout period of at least 10 days between each drug administration of adjacent treatment periods. First, they were administered a single dose of test cocktail (T) comprised of 0.25 mg of Digoxin, 0.1 mL (1 mg) of Furosemide, 0.1 mL (10 mg) of Metformin hydrochloride and 10 mg of Rosuvastatin. Second, they were administered a single dose of 10 mg film-coated tablet of Rosuvastatin (R4). Third, they were administered a single dose of 0.25 milligram (mg) tablet of Digoxin (R1). Fourth, they were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride (R3). Fifth, they were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide (R2).~All drugs were administered orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours."
11283791|NCT02854527|OG000|Outcome|Test Cocktail (T)|Subjects were administered a single dose of test cocktail (T) comprised of 0.25 mg tablet of Digoxin, 0.1 mL (1 mg) oral solution of Furosemide, 0.1 mL (10 mg) oral solution of Metformin hydrochloride and 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283792|NCT02854527|OG001|Outcome|Digoxin (R1)|Subjects were administered a single dose of 0.25 milligram (mg) tablet of Digoxin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283793|NCT02854527|OG001|Outcome|Furosemide (R2)|Subjects were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283794|NCT02854527|OG001|Outcome|Metformin Hydrochloride (R3)|Subjects were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283795|NCT02854527|OG001|Outcome|Rosuvastatin (R4)|Subjects were administered a single dose of 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283796|NCT02854527|EG000|Reported Event|Digoxin (R1)|Subjects were administered a single dose of 0.25 milligram (mg) tablet of Digoxin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283797|NCT02854527|EG001|Reported Event|Furosemide (R2)|Subjects were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283798|NCT02854527|EG002|Reported Event|Metformin Hydrochloride (R3)|Subjects were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283799|NCT02854527|EG003|Reported Event|Rosuvastatin (R4)|Subjects were administered a single dose of 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283800|NCT02854527|EG004|Reported Event|Test Cocktail (T)|Subjects were administered a single dose of test cocktail (T) comprised of 0.25 mg tablet of Digoxin, 0.1 mL (1 mg) oral solution of Furosemide, 0.1 mL (10 mg) oral solution of Metformin hydrochloride and 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours.
11283801|NCT02854540|BG000|Baseline|All Participants|"Hand A was treated with hydrogel electrode-based iontophoresis. Hand B did not receive treatment.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283802|NCT02854540|FG000|Participant Flow|All Participants|"Hand A was treated with hydrogel electrode-based iontophoresis. Hand B did not receive treatment.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283803|NCT02854540|OG000|Outcome|Hand A (Iontophoresis)|"Hand A was treated with hydrogel electrode-based iontophoresis.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283804|NCT02854540|OG001|Outcome|Hand B (no Treatment)|"Hand B did not receive treatment.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283805|NCT02854540|EG000|Reported Event|Hand A (Iontophoresis)|"Hand A was treated with hydrogel electrode-based iontophoresis.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283806|NCT02854540|EG001|Reported Event|Hand B (no Treatment)|"Hand B did not receive treatment.~Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated."
11283807|NCT02854605|BG000|Baseline|GS-9674 100 mg|GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.
11283808|NCT02854605|BG001|Baseline|GS-9674 30 mg|GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283809|NCT02854605|BG002|Baseline|Placebo|PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283810|NCT02854605|BG003|Baseline|Total|Total of all reporting groups
11283811|NCT02854605|FG000|Participant Flow|GS-9674 100 mg|GS-9674 100 mg tablet once daily + placebo-to-match (PTM) GS-9674 30 mg tablet once daily for 24 weeks.
11283812|NCT02854605|FG001|Participant Flow|GS-9674 30 mg|GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283813|NCT02854605|FG002|Participant Flow|Placebo|PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283814|NCT02854605|OG000|Outcome|GS-9674 100 mg|GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.
11283815|NCT02854605|OG001|Outcome|GS-9674 30 mg|GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283816|NCT02854605|OG002|Outcome|Placebo|PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283817|NCT02854605|EG000|Reported Event|GS-9674 100 mg|GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.
11283818|NCT02854605|EG001|Reported Event|GS-9674 30 mg|GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283819|NCT02854605|EG002|Reported Event|Placebo|PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
11283820|NCT02854631|BG000|Baseline|Selonsertib + Prednisolone|Participants received selonsertib (GS-4997) 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283821|NCT02854631|BG001|Baseline|Placebo + Prednisolone|Participants received placebo-to-match selonsertib 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283822|NCT02854631|BG002|Baseline|Total|Total of all reporting groups
11283823|NCT02854631|FG000|Participant Flow|Selonsertib + Prednisolone|Participants received selonsertib (GS-4997) 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283824|NCT02854631|FG001|Participant Flow|Placebo + Prednisolone|Participants received placebo-to-match selonsertib 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283825|NCT02854631|OG000|Outcome|Selonsertib + Prednisolone|Participants received selonsertib (GS-4997) 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283826|NCT02854631|OG001|Outcome|Placebo + Prednisolone|Participants received placebo-to-match selonsertib 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283827|NCT02854631|EG000|Reported Event|Selonsertib + Prednisolone|Participants received selonsertib (GS-4997) 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283828|NCT02854631|EG001|Reported Event|Placebo + Prednisolone|Participants received placebo-to-match selonsertib 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days.
11283829|NCT02854800|BG000|Baseline|Weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283830|NCT02854800|BG001|Baseline|Bi-weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283831|NCT02854800|BG002|Baseline|Monthly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283832|NCT02854800|BG003|Baseline|Total|Total of all reporting groups
11283833|NCT02854800|FG000|Participant Flow|Weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283834|NCT02854800|FG001|Participant Flow|Bi-weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283835|NCT02854800|FG002|Participant Flow|Monthly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283836|NCT02854800|OG000|Outcome|Weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283837|NCT02854800|OG001|Outcome|Bi-weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283838|NCT02854800|OG002|Outcome|Monthly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283839|NCT02854800|OG000|Outcome|Dropouts|Participants that were enrolled and assigned to treatment, but did not complete the entire 12-week study protocol.
11283840|NCT02854800|OG001|Outcome|Completers|Participants that were enrolled and completed the entire 12-week protocol.
11283841|NCT02854800|OG000|Outcome|All Participants Aggregated|12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283842|NCT02854800|EG000|Reported Event|Weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283843|NCT02854800|EG001|Reported Event|Bi-weekly Opioid Tx|Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283844|NCT02854800|EG002|Reported Event|Monthly Opioid Tx|Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
11283845|NCT02855086|BG000|Baseline|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283846|NCT02855086|BG001|Baseline|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283847|NCT02855086|BG002|Baseline|Total|Total of all reporting groups
11283848|NCT02855086|FG000|Participant Flow|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283849|NCT02855086|FG001|Participant Flow|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283850|NCT02855086|OG000|Outcome|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283851|NCT02855086|OG001|Outcome|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283852|NCT02855086|EG000|Reported Event|Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283853|NCT02855086|EG001|Reported Event|Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)|"Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.~All patients undergo standard of care surgical resection of tumor on days 2 to 5.~Cetuximab: Given IV~Cetuximab-IRDye 800CW: Given IV~Conventional Surgery: Undergo tumor resection~Laboratory Biomarker Analysis: Correlative studies"
11283854|NCT02855164|BG000|Baseline|LJN452 10 μg|10 micrograms of Tropifexor (Part A)
11283855|NCT02855164|BG001|Baseline|LJN452 30 μg|30 micrograms of Tropifexor (Part A)
11283856|NCT02855164|BG002|Baseline|LJN452 60 μg|60 micrograms of Tropifexor (Parts A+B)
11283857|NCT02855164|BG003|Baseline|LJN452 90 μg|90 micrograms of Tropifexor (Parts A + B)
11283858|NCT02855164|BG004|Baseline|Placebo A+B|Placebo (Parts A+B)
11283859|NCT02855164|BG005|Baseline|LJN452 140 μg|140 micrograms of Tropifexor (Part C)
11283860|NCT02855164|BG006|Baseline|LJN452 200 μg|200 micrograms of Tropifexor (Part C)
11283861|NCT02855164|BG007|Baseline|Placebo C|Placebo (Part C)
11283862|NCT02855164|BG008|Baseline|Total|Total of all reporting groups
11283863|NCT02855164|FG000|Participant Flow|LJN452 10 μg|10 micrograms of Tropifexor (Part A)
11283864|NCT02855164|FG001|Participant Flow|LJN452 30 μg|30 micrograms of Tropifexor (Part A)
11283865|NCT02855164|FG002|Participant Flow|LJN452 60 μg|60 micrograms of Tropifexor (Parts A+B)
10820430|NCT00057876|FG001|Participant Flow|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
10820431|NCT00057876|OG000|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
11092427|NCT01539837|BG002|Baseline|Deferiprone 30mg|30mg/kg/day Deferiprone divided into two equal doses (morning and evening), every day for 6 months
11092428|NCT01539837|BG003|Baseline|Total|Total of all reporting groups
11283866|NCT02855164|FG003|Participant Flow|LJN452 90 μg|90 micrograms of Tropifexor (Parts A + B)
11283867|NCT02855164|FG004|Participant Flow|Placebo A+B|Placebo A+B
11283868|NCT02855164|FG005|Participant Flow|LJN452 140 μg|140 micrograms of Tropifexor (Part C)
11092429|NCT01539837|FG000|Participant Flow|Placebo|Feriprox placebo administered orally at the same dosing volume as the 20mg/kg/day feriprox per day
11092430|NCT01539837|FG001|Participant Flow|Deferiprone 20mg|20mg/kg/day deferiprone divided into two equal doses (morning and evening), every day for 6 months
11215173|NCT02297100|BG000|Baseline|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215174|NCT02297100|BG001|Baseline|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215175|NCT02297100|BG002|Baseline|Total|Total of all reporting groups
11215176|NCT02297100|FG000|Participant Flow|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215177|NCT02297100|FG001|Participant Flow|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215178|NCT02297100|OG000|Outcome|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215179|NCT02297100|OG001|Outcome|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215180|NCT02297100|EG000|Reported Event|Botox Upper Aspect Trigone|"Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215181|NCT02297100|EG001|Reported Event|Botox Periphery of Trigone|"Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).~Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections~injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder."
11215182|NCT02297308|BG000|Baseline|SoloPath Sheath|The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
11215183|NCT02297308|FG000|Participant Flow|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
11215184|NCT02297308|OG000|Outcome|SoloPath Sheath|Vascular Complications
11215185|NCT02297308|OG000|Outcome|SoloPath Sheath|Rate of VARC-2 defined access site bleeding complications.
11215186|NCT02297308|EG000|Reported Event|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
11215187|NCT02297503|BG000|Baseline|Azzalure Alone as Initial Treatment|Azzalulre alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11215188|NCT02297503|BG001|Baseline|Filler Alone as Initial Treatment|Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11215189|NCT02297503|BG002|Baseline|Total|Total of all reporting groups
11215190|NCT02297503|FG000|Participant Flow|Azzalure Alone as Initial Treatment|Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11283869|NCT02855164|FG006|Participant Flow|LJN452 200 μg|200 micrograms of Tropifexor (Part C)
11283870|NCT02855164|FG007|Participant Flow|Placebo C|Placebo (Part C)
11283871|NCT02855164|OG000|Outcome|LJN452 10 μg|10 micrograms of Tropifexor (Part A)
11283872|NCT02855164|OG001|Outcome|LJN452 30 μg|30 micrograms of Tropifexor (Part A)
11283873|NCT02855164|OG002|Outcome|LJN452 60 μg|60 micrograms of Tropifexor (Parts A+B)
11283874|NCT02855164|OG003|Outcome|LJN452 90 μg|90 micrograms of Tropifexor (Parts A+B)
11283875|NCT02855164|OG004|Outcome|Placebo A+B|Placebo (Parts A+B)
11283876|NCT02855164|OG005|Outcome|LJN452 140 μg|140 micrograms of Tropifexor (Part C)
11283877|NCT02855164|OG006|Outcome|LNJ452 200 μg|200 micrograms of Tropifexor (Part C)
11283878|NCT02855164|OG007|Outcome|Placebo Part C|Placebo (Part C)
11283879|NCT02855164|OG002|Outcome|LJN452 60 μg|60 micrograms of Tropifexor (Parts A + B)
11283880|NCT02855164|OG003|Outcome|LJN452 90 μg|90 micrograms of Tropifexor (Parts A + B)
11283881|NCT02855164|OG006|Outcome|LJN452 200 μg|200 micrograms of Tropifexor (Part C)
11283882|NCT02855164|OG001|Outcome|LJN452 30 μg|30 micrograms of Tropifexor (Part A) vs placebo
11283883|NCT02855164|OG007|Outcome|Placebo (Part C)|Placebo (Part C)
11283884|NCT02855164|OG001|Outcome|LJN452 30 μg|30 micrograms of Tropifexor (Parts A + B)
11283885|NCT02855164|OG005|Outcome|LJN452 140 μg|140 micrograms of Tropifexor (Part C) vs placebo
11283886|NCT02855164|OG007|Outcome|Placebo Part C|(Part C)
11283887|NCT02855164|OG004|Outcome|Placebo (A+B)|Placebo (Parts A+B)
11283888|NCT02855164|OG000|Outcome|LJN452 140 μg|140 micrograms of Tropifexor (Part C)
11283889|NCT02855164|OG001|Outcome|LJN452 200 μg|200 micrograms of Tropifexor (Part C)
11283890|NCT02855164|OG002|Outcome|Placebo A+B|Placebo A+B
11283891|NCT02855164|OG007|Outcome|Placebo C|Placebo (Part C)
11283892|NCT02855164|OG002|Outcome|LJN452 60 μg|60 micrograms of Tropifexor (Parts A + B) vs placebo
11283893|NCT02855164|OG004|Outcome|Placebo A+B|Placebo for parts A + B
11283894|NCT02855164|OG000|Outcome|LJN452 10 μg|10 micrograms of Tropifexor (Parts A + B)
11283895|NCT02855164|OG004|Outcome|LJN452 140 μg|140 micrograms of Tropifexor (Part C)
11283896|NCT02855164|OG005|Outcome|LJN452 200 μg|200 micrograms of Tropifexor (Part C)
11283897|NCT02855164|OG001|Outcome|LNJ452 200 μg|200 micrograms of Tropifexor (Part C)
11283898|NCT02855164|OG002|Outcome|Placebo C|Placebo (Part C)
11283899|NCT02855164|EG000|Reported Event|LJN452 10 μg|LJN452 10 mcg (Part A)
11283900|NCT02855164|EG001|Reported Event|LJN452 30 μg|30 micrograms of Tropifexor (Part A)
11283901|NCT02855164|EG002|Reported Event|LJN452 60 μg|LJN452 60 mcg (Parts A+B)
11283902|NCT02855164|EG003|Reported Event|LJN452 90 μg|90 micrograms of Tropifexor (Parts A + B)
11283903|NCT02855164|EG004|Reported Event|LJN452 140 μg|LJN452 140 mcg (Part C)
11283904|NCT02855164|EG005|Reported Event|LJN452 200 μg|LJN452 200 mcg (Part C)
11283905|NCT02855164|EG006|Reported Event|Placebo|Placebo A+B+C
11283906|NCT02855164|EG007|Reported Event|Total|Total
11283907|NCT02855281|BG000|Baseline|Malignant Pleural Effusion|patients with confirmed malignant pleural effusion
11283908|NCT02855281|FG000|Participant Flow|Malignant Pleural Effusion|Patients with confirmed malignant pleural effusion
11283909|NCT02855281|OG000|Outcome|Number of PD-L1-positive Samples in IHC|For the assessment of potentially therapy-relevant PD-L1 expression levels, two different threshold levels of PD-L1 expression were considered as per the differing approval status (TPS ≥50% and TPS≥1%). Regarding detection of malignancy and PD-L1-positivity, results were defined as negative where the tests were not feasible or in case of inconclusive findings.
11283910|NCT02855281|OG000|Outcome|Number of PD-L1-positive Samples in ICC|For the assessment of potentially therapy-relevant PD-L1 expression levels, two different threshold levels of PD-L1 expression were considered as per the differing approval status (TPS ≥50% and TPS≥1%). Regarding detection of malignancy and PD-L1-positivity, results were defined as negative where the tests were not feasible or in case of inconclusive findings.
11283911|NCT02855281|OG000|Outcome|Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥50%)|Sensitivity and specificity of PD-L1 detection in pleural effusion. PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive.
11283912|NCT02855281|OG001|Outcome|Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥1%)|Sensitivity and specificity of PD-L1 detection in pleural effusion. PD-L1 expression with a TPS ≥ 1% was defined as PD-L1 positive.
11283913|NCT02855281|OG000|Outcome|Sensitivity and Specificity of Tumor Cell Detection|Sensitivity and specificity of tumor cell detection in pleural effusion. Seven cases of ICC analysis with inconclusive results defined as negative.
11283914|NCT02855281|EG000|Reported Event|NSCLC With Pleural Effusion|The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis.
11283915|NCT02855359|BG000|Baseline|Denintuzumab Mafodotin + RCHP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11337702|NCT03591146|EG004|Reported Event|Naropin 150mg|"Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial~Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL"
11283916|NCT02855359|BG001|Baseline|Denintuzumab Mafodotin + RCHOP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283917|NCT02855359|BG002|Baseline|Total|Total of all reporting groups
11283918|NCT02855359|FG000|Participant Flow|Denintuzumab Mafodotin + RCHP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283919|NCT02855359|FG001|Participant Flow|Denintuzumab Mafodotin + RCHOP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283920|NCT02855359|FG002|Participant Flow|Denintuzumab Mafodotin + RCHOP or RCHP|"Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283921|NCT02855359|FG003|Participant Flow|RCHOP|"Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283922|NCT02855359|OG000|Outcome|Denintuzumab Mafodotin + RCHP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283923|NCT02855359|OG001|Outcome|Denintuzumab Mafodotin + RCHOP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283924|NCT02855359|OG002|Outcome|Denintuzumab Mafodotin + RCHOP or RCHP|"Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283925|NCT02855359|OG003|Outcome|RCHOP|"Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283926|NCT02855359|EG000|Reported Event|Denintuzumab Mafodotin + RCHP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283927|NCT02855359|EG001|Reported Event|Denintuzumab Mafodotin + RCHOP|"Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)~denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles~rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles~vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)~prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles"
11283928|NCT02855437|BG000|Baseline|Overall|"Overall description of participants in the pilot study entitled, Novel Methods for Ascertainment of Gout Flares -A Pilot Study"
11283929|NCT02855437|FG000|Participant Flow|Interactive Voice Response, Then RheumPRO|IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack if completed. We will capture patient reported outcome measures (e.g. pain, fatigue, sleep) using instruments from NIH PROMIS. Following completion of 26 week IVR period participants will crossover to RheumPro arm.
11283930|NCT02855437|FG001|Participant Flow|RheumPro Smartphone Application, Then IVR|"RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled pop-up to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more pop-ups at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. Following completion of 26 week RheumPro period participants will crossover to IVR arm."
11283931|NCT02855437|OG000|Outcome|Interactive Voice Response|"The interactive voice response system (IVR) is an automated telephone system that is used to contact participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed.~IVR (Phone call): IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack"
11283932|NCT02855437|OG001|Outcome|RheumPro Smartphone Application|"RheumPro is a UAB developed smartphone application to capture patient reported outcomes. At enrollment the study coordinator will explain how RheumPro works, planned survey schedule, and that participant -initiated surveys in RheumPro are allowed.~RheumPro (Smartphone application): RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled pop-up to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more pop-ups at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. In addition RheumPro questionnaires at months 1 , 3, and 6 will assess RheumPro ease of use."
11283933|NCT02855437|OG001|Outcome|RheumPro Smartphone Application|"RheumPro is a UAB developed smartphone application to capture patient reported outcomes. At enrollment the study coordinator will explain how RheumPro works, planned survey schedule, and that participant -initiated surveys in RheumPro are allowed.~RheumPro (Smartphone application): RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled pop-up to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more pop-ups at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. In addition RheumPro questionnaires at months 1 , 3, and 6 will assess RheumPro ease of use,"
11283934|NCT02855437|EG000|Reported Event|Interactive Voice Response|"The interactive voice response system (IVR) is an automated telephone system that is used to contact participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed.~IVR (Phone call): IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack"
11283935|NCT02855437|EG001|Reported Event|RheumPro Smartphone Application|"RheumPro is a UAB developed smartphone application to capture patient reported outcomes. At enrollment the study coordinator will explain how RheumPro works, planned survey schedule, and that participant -initiated surveys in RheumPro are allowed.~RheumPro (Smartphone application): RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled pop-up to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more pop-ups at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. In addition RheumPro questionnaires at months 1 , 3, and 6 will assess RheumPro ease of use,"
11283936|NCT02855450|BG000|Baseline|rhNGF|"rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution~rhNGF: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment."
11283937|NCT02855450|BG001|Baseline|Vehicle|"Ophthalmic Placebo solution~Vehicle: Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment."
11283938|NCT02855450|BG002|Baseline|Total|Total of all reporting groups
11283939|NCT02855450|FG000|Participant Flow|rhNGF|"rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution~rhNGF: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment."
11283940|NCT02855450|FG001|Participant Flow|Vehicle|"Ophthalmic Placebo solution~Vehicle: Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment."
11283941|NCT02855450|OG000|Outcome|rhNGF|"rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution~rhNGF: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment."
11283942|NCT02855450|OG001|Outcome|Vehicle|"Ophthalmic Placebo solution~Vehicle: Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment."
11283943|NCT02855450|EG000|Reported Event|rhNGF|"rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution~rhNGF: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment."
11283944|NCT02855450|EG001|Reported Event|Vehicle|"Ophthalmic Placebo solution~Vehicle: Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment."
11283945|NCT02855541|BG000|Baseline|Cycling Intervention|"Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work.~DeskCycle: A small cycling ergometer that can fit under a desk at the workplace."
11283946|NCT02855541|FG000|Participant Flow|Cycling Intervention|"Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work.~DeskCycle: A small cycling ergometer that can fit under a desk at the workplace."
11283947|NCT02855541|OG000|Outcome|Cycling Intervention|"Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work.~DeskCycle: A small cycling ergometer that can fit under a desk at the workplace."
11283948|NCT02855541|EG000|Reported Event|Cycling Intervention|"Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work.~DeskCycle: A small cycling ergometer that can fit under a desk at the workplace."
11283949|NCT02855567|BG000|Baseline|Acupuncture|Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
11283950|NCT02855567|BG001|Baseline|Sham Acupuncture|Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
11283951|NCT02855567|BG002|Baseline|Total|Total of all reporting groups
11283952|NCT02855567|FG000|Participant Flow|Acupuncture|Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
11283953|NCT02855567|FG001|Participant Flow|Sham Acupuncture|Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
11283954|NCT02855567|OG000|Outcome|Acupuncture|Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
11283955|NCT02855567|OG001|Outcome|Sham Acupuncture|Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
11283956|NCT02855567|EG000|Reported Event|Acupuncture|Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
11283957|NCT02855567|EG001|Reported Event|Sham Acupuncture|Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
11283958|NCT02856035|BG000|Baseline|Arm/Group|4 Stroke survivors > 6 months post stroke and moderately/severely impaired in upper limb coordination and function.
11283959|NCT02856035|FG000|Participant Flow|Stroke Group|"Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions.~Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends"
11283960|NCT02856035|OG000|Outcome|Stroke Group|"Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions.~Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends"
11283961|NCT02856035|EG000|Reported Event|Stroke Group|"Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions.~Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends"
11283962|NCT02856282|BG000|Baseline|Pirinase Hayfever Relief for Adults 0.05% Nasal Spray|Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).
11283963|NCT02856282|FG000|Participant Flow|Pirinase Hayfever Relief for Adults 0.05% Nasal Spray|Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).
11283964|NCT02856282|OG000|Outcome|Pirinase Hayfever Relief for Adults 0.05% Nasal Spray|Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).
11283965|NCT02856282|EG000|Reported Event|Pirinase Hayfever Relief for Adults 0.05% Nasal Spray|Participants were advised to take Pirinase Hayfever Relief for Adults 0.05 percent (%) Nasal Spray (an aqueous suspension of 0.05% micronised fluticasone propionate), two sprays into each nostril once a day, preferably in the morning for at least 7 days. Participants were invited to complete the online survey if they qualified the screening and were using the product for at least 1 month. Data collection continued through 2 allergy seasons (up to a maximum of 2 years).
11283966|NCT02856490|BG000|Baseline|vSculpt With Vibration Only|"vSculpt genital device used in vibration mode only.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283967|NCT02856490|BG001|Baseline|vSculpt With Vibration and Light|"vSculpt genital device used in vibration and light mode.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283968|NCT02856490|BG002|Baseline|InTone Device|"InTone genital device using electric muscle stimulation only.~InTone: A genital device using electric muscle stimulation to treat incontinence."
11283969|NCT02856490|BG003|Baseline|Total|Total of all reporting groups
11283970|NCT02856490|FG000|Participant Flow|vSculpt With Vibration Only|"vSculpt genital device used in vibration mode only.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283971|NCT02856490|FG001|Participant Flow|vSculpt With Vibration and Light|"vSculpt genital device used in vibration and light mode.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283972|NCT02856490|FG002|Participant Flow|InTone Device|"InTone genital device using electric muscle stimulation only.~InTone: A genital device using electric muscle stimulation to treat incontinence."
11283973|NCT02856490|OG000|Outcome|vSculpt With Vibration Only|"vSculpt genital device used in vibration mode only.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283974|NCT02856490|OG001|Outcome|vSculpt With Vibration and Light|"vSculpt genital device used in vibration and light mode.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283975|NCT02856490|OG002|Outcome|InTone Device|"InTone genital device using electric muscle stimulation only.~InTone: A genital device using electric muscle stimulation to treat incontinence."
11283976|NCT02856490|EG000|Reported Event|vSculpt With Vibration Only|"vSculpt genital device used in vibration mode only.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283977|NCT02856490|EG001|Reported Event|vSculpt With Vibration and Light|"vSculpt genital device used in vibration and light mode.~vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles."
11283978|NCT02856490|EG002|Reported Event|InTone Device|"InTone genital device using electric muscle stimulation only.~InTone: A genital device using electric muscle stimulation to treat incontinence."
11283979|NCT02856555|BG000|Baseline|Firsocostat 5 mg|Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283980|NCT02856555|BG001|Baseline|Firsocostat 20 mg|Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.
11283981|NCT02856555|BG002|Baseline|Placebo|Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283982|NCT02856555|BG003|Baseline|Total|Total of all reporting groups
11283983|NCT02856555|FG000|Participant Flow|Firsocostat 5 mg|Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283984|NCT02856555|FG001|Participant Flow|Firsocostat 20 mg|Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.
11283985|NCT02856555|FG002|Participant Flow|Placebo|Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283986|NCT02856555|OG000|Outcome|Firsocostat 5 mg|Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283987|NCT02856555|OG001|Outcome|Firsocostat 20 mg|Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.
11283988|NCT02856555|OG002|Outcome|Placebo|Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283989|NCT02856555|EG000|Reported Event|Firsocostat 5 mg|Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283990|NCT02856555|EG001|Reported Event|Firsocostat 20 mg|Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.
11283991|NCT02856555|EG002|Reported Event|Placebo|Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
11283992|NCT02856802|BG000|Baseline|DFN-02 (Double-Blind Treatment Period 1)|50 of 54 randomized subjects started and were dosed; 2 subjects had no migraine attack, 1 subject withdrew and 1 subject was lost to follow-up. Per protocol these 4 subjects are excluded from analysis.
11283993|NCT02856802|BG001|Baseline|Placebo (Double-Blind Treatment Period 1)|43 of 53 randomized subjects started and were dosed; 6 subjects had no migraine attack, 3 subjects withdrew and 1 subject was terminated by the sponsor. Per protocol these 10 subjects are excluded from analysis.
11283994|NCT02856802|BG002|Baseline|Total|Total of all reporting groups
11283995|NCT02856802|FG000|Participant Flow|DFN-02|"DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode~DFN-02"
11283996|NCT02856802|FG001|Participant Flow|Placebo|"DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Placebo"
11283997|NCT02856802|OG000|Outcome|DFN-02 (DB1)|"DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode~DFN-02"
11283998|NCT02856802|OG001|Outcome|Placebo (DB1)|"DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Placebo"
11283999|NCT02856802|OG000|Outcome|DFN-02 (DB2)|"Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode.~Sumatriptan 10 MG Nasal Spray: 100 μL nasal spray once"
11284000|NCT02856802|OG001|Outcome|Placebo (DB2)|"Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode.~Sumatriptan Placebo Nasal Spray: 100 μL nasal spray once"
11284001|NCT02856802|EG000|Reported Event|DFN-02 (DB1)|"DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Active in Double-blind Treatment Period 1"
11284002|NCT02856802|EG001|Reported Event|Placebo (DB1)|"DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Placebo in Double-blind Treatment Period 1"
11284003|NCT02856802|EG002|Reported Event|DFN-02 (DB2)|"DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Active in Double-blind Treatment Period 2"
11284004|NCT02856802|EG003|Reported Event|Placebo (DB2)|"DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode~DFN-02 Placebo in Double-blind Treatment Period 2"
11284005|NCT02856828|BG000|Baseline|Digital Image Enhancement (DIE) Group|"A novel digital image enhancement technology will be used intraoperatively~DIE: digital image enhancement"
11284006|NCT02856828|BG001|Baseline|Control Group|Standard intraoperative imaging will be used intraoperatively
11284007|NCT02856828|BG002|Baseline|Total|Total of all reporting groups
11284008|NCT02856828|FG000|Participant Flow|Digital Image Enhancement (DIE) Group|"A novel digital image enhancement technology will be used intraoperatively~DIE: digital image enhancement"
11284009|NCT02856828|FG001|Participant Flow|Control Group|Standard intraoperative imaging will be used intraoperatively
11284010|NCT02856828|OG000|Outcome|Digital Image Enhancement (DIE) Group|The radiation exposure to the patient in the digital image enhancement group.
11284011|NCT02856828|OG001|Outcome|Control Group|The radiation exposure to the patient in the standard intraoperative imaging group.
11284012|NCT02856828|OG000|Outcome|Digital Image Enhancement (DIE) Group|The radiation exposure to the primary surgeon of the participants from the novel digital image enhancement group.
11284013|NCT02856828|OG001|Outcome|Control Group|The radiation exposure of the primary surgeon of the participants in the standard intraoperative imaging group.
11284014|NCT02856828|OG000|Outcome|Digital Image Enhancement (DIE) Group|The radiation exposure to the surgical technician of the participants from the novel digital image enhancement group.
11284015|NCT02856828|OG001|Outcome|Control Group|The radiation exposure of the surgical technician of the participants in the standard intraoperative imaging group.
11284016|NCT02856828|OG000|Outcome|Image Quality of the Digital Image Enhancement (DIE) Group|"The image quality, on a scale of 1-10 with 10 being the best quality, obtained for the novel digital image enhancement technology that was used intraoperatively.~DIE: digital image enhancement"
11284017|NCT02856828|OG001|Outcome|Image Quality of the Control Group|The image quality, on a scale of 1-10 with 10 being the best quality, obtained for the standard intraoperative imaging that was used intraoperatively.
11284018|NCT02856828|OG000|Outcome|Digital Image Enhancement (DIE) Group|Operative time of the participants in the Digital Image Enhancement Group.
11284019|NCT02856828|OG001|Outcome|Control Group|Operative time of the participants in the Standard Intraoperative Group.
11284020|NCT02856828|EG000|Reported Event|Digital Image Enhancement (DIE) Group|"A novel digital image enhancement technology will be used intraoperatively~DIE: digital image enhancement"
11284021|NCT02856828|EG001|Reported Event|Control Group|Standard intraoperative imaging will be used intraoperatively
11284022|NCT02856880|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
11284023|NCT02856880|FG000|Participant Flow|Overall Study|This was a single-centre, analyst and examiner (plaque sample collector)-blind, randomized, five-treatment, five-period, cross-over study in healthy adult participants. Each participant received each of the five interventions i.e., Test Zinc-isopropylmethylphenol (IPMP), Test Zinc non-IPMP, Positive control, non-sodium lauryl sulphate (SLS) negative control, SLS negative control.
11284024|NCT02856880|OG000|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
11284025|NCT02856880|OG001|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284026|NCT02856880|OG000|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
11284027|NCT02856880|OG001|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
11284028|NCT02856880|OG002|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
11284029|NCT02856880|OG003|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
11284030|NCT02856880|OG004|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
11284031|NCT02856880|OG000|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284032|NCT02856880|OG001|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284033|NCT02856880|OG002|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
11284034|NCT02856880|OG003|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284035|NCT02856880|OG004|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284036|NCT02856880|EG000|Reported Event|Test Zinc-IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284037|NCT02856880|EG001|Reported Event|Test Zinc Non- IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284038|NCT02856880|EG002|Reported Event|Positive Control Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
11284039|NCT02856880|EG003|Reported Event|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284040|NCT02856880|EG004|Reported Event|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
11284041|NCT02857283|BG000|Baseline|Filtered Air; Then Ozone|Participants were exposed to filtered clean air for 6.5 hours, and after a minimum of a 2-week washout, they returned and were exposed to 0.06-0.08 PPM ozone for 6.5 hours. All participants wore a Health and Exposure Tracker (HET): Ozone and heart rate tracker during both exposures
11284042|NCT02857283|BG001|Baseline|Ozone; Then Filtered Air|Participants were exposed to 0.06-0.08 PPM ozone for 6.5 hours, and after a minimum of a 2-week washout, they returned and were exposed to filtered clean air for 6.5 hours. All participants wore a Health and Exposure Tracker (HET): Ozone and heart rate tracker during both exposures
11284043|NCT02857283|BG002|Baseline|Total|Total of all reporting groups
11284044|NCT02857283|FG000|Participant Flow|Filtered Air; Then Ozone|Participants were exposed to filtered clean air for 6.5 hours, and after a minimum of a 2-week washout, they returned and were exposed to 0.06-0.08 Parts Per Million (PPM) ozone for 6.5 hours. All participants wore a Health and Exposure Tracker (HET): Ozone and heart rate tracker during both exposures.
11284045|NCT02857283|FG001|Participant Flow|Ozone; Then Filtered Air|Participants were exposed to 0.06-0.08 PPM ozone for 6.5 hours, and after a minimum of a 2-week washout, they returned and were exposed to filtered clean air for 6.5 hours. All participants wore a Health and Exposure Tracker (HET): Ozone and heart rate tracker during both exposures.
11284046|NCT02857283|OG000|Outcome|Filtered Air|Participants will be exposed to filtered clean air for 6.5 hours
11284047|NCT02857283|OG001|Outcome|Ozone|Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08 Parts Per Million (PPM)
11284048|NCT02857283|OG001|Outcome|Ozone|Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08 PPM
11284049|NCT02857283|EG000|Reported Event|Filtered Air|Filtered Air: Participants will be exposed to filtered clean air for 6.5 hours
11284050|NCT02857283|EG001|Reported Event|Ozone|Ozone: Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08 PPM
11284051|NCT02857816|BG000|Baseline|NURO System PTNM Therapy|"Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.~NURO System PTNM Therapy"
11284052|NCT02857816|FG000|Participant Flow|NURO System PTNM Therapy|Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy
11284053|NCT02857816|OG000|Outcome|NURO System PTNM Therapy|"Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.~NURO System PTNM Therapy"
11284054|NCT02857816|OG000|Outcome|NURO System PTNM Therapy|Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy
11284055|NCT02857816|EG000|Reported Event|NURO System PTNM Therapy|"Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy.~In the summary of serious AEs below, none of the serous AEs were found to be related to device, therapy or study procedure. The other events reported in this study were non-serious device related and/or therapy/procedure related."
11284056|NCT02858050|BG000|Baseline|Portal-724 MEMs Cap Real-Time Monitoring|"Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time~Portal-724 MEMs Cap"
11284057|NCT02858050|BG001|Baseline|Portal-724 MEMs Cap Without Real-Time Monitoring|"Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications~Portal-724 MEMs Cap"
11284058|NCT02858050|BG002|Baseline|Total|Total of all reporting groups
11284059|NCT02858050|FG000|Participant Flow|Portal-724 MEMs Cap Real-Time Monitoring|"Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time~Portal-724 MEMs Cap"
11284060|NCT02858050|FG001|Participant Flow|Portal-724 MEMs Cap Without Real-Time Monitoring|"Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications~Portal-724 MEMs Cap"
11284061|NCT02858050|OG000|Outcome|Portal-724 MEMs Cap Real-Time Monitoring|"Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time~Portal-724 MEMs Cap"
11284062|NCT02858050|OG001|Outcome|Portal-724 MEMs Cap Without Real-Time Monitoring|"Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications~Portal-724 MEMs Cap"
11284063|NCT02858050|EG000|Reported Event|Portal-724 MEMs Cap Real-Time Monitoring|"Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time~Portal-724 MEMs Cap"
11284064|NCT02858050|EG001|Reported Event|Portal-724 MEMs Cap Without Real-Time Monitoring|"Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications~Portal-724 MEMs Cap"
11284065|NCT02858076|BG000|Baseline|Intravitreous 2 mg Aflibercept Injections|"Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.~2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor."
11284066|NCT02858076|BG001|Baseline|Prompt Vitrectomy Plus Panretinal Photocoagulation|"For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.~Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser"
11284067|NCT02858076|BG002|Baseline|Total|Total of all reporting groups
11284068|NCT02858076|FG000|Participant Flow|Intravitreous 2 mg Aflibercept Injections|"Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.~2 mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of vascular endothelial growth factor (VEGF) as well as to placental growth factor."
11284069|NCT02858076|FG001|Participant Flow|Vitrectomy With Panretinal Photocoagulation|"For the prompt vitrectomy with panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.~Vitrectomy with Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser"
11284070|NCT02858076|OG000|Outcome|Intravitreous 2 mg Aflibercept Injections|"Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.~2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor."
11284071|NCT02858076|OG001|Outcome|Prompt Vitrectomy Plus Panretinal Photocoagulation|"For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.~Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser"
11284072|NCT02858076|OG000|Outcome|Intravitreous 2 mg Aflibercept Injections|"Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.~2 mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of vascular endothelial growth factor (VEGF) as well as to placental growth factor."
11284073|NCT02858076|OG001|Outcome|Vitrectomy With Panretinal Photocoagulation|"For the prompt vitrectomy with panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.~Vitrectomy with Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser"
11284074|NCT02858076|EG000|Reported Event|Intravitreous 2 mg Aflibercept Injections|"Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.~2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor."
11284075|NCT02858076|EG001|Reported Event|Prompt Vitrectomy Plus Panretinal Photocoagulation|"For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.~Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser"
11284076|NCT02858180|BG000|Baseline|Heart Failure Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284077|NCT02858180|BG001|Baseline|Lung Disease Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284078|NCT02858180|BG002|Baseline|Total|Total of all reporting groups
11284079|NCT02858180|FG000|Participant Flow|Heart Failure Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284080|NCT02858180|FG001|Participant Flow|Lung Disease Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284081|NCT02858180|OG000|Outcome|Heart Failure Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284082|NCT02858180|OG001|Outcome|Lung Disease Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11092431|NCT01539837|FG002|Participant Flow|Deferiprone 30mg|30mg/kg/day Deferiprone divided into two equal doses (morning and evening), every day for 6 months
11284083|NCT02858180|EG000|Reported Event|Heart Failure Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284084|NCT02858180|EG001|Reported Event|Lung Disease Cohort|"Harvoni (sofosbuvir/ledipasvir fixed dose combination)~1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir~Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC"
11284085|NCT02858349|BG000|Baseline|Arm 1|"4-week control period with no intervention and 4-weeks of high-intensity interval training~No intervention: No intervention~High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods"
11284086|NCT02858349|FG000|Participant Flow|Arm 1|"4-week control period with no intervention and 4-weeks of high-intensity interval training~No intervention: No intervention~High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods"
11284087|NCT02858349|OG000|Outcome|Arm 1|"4-week control period with no intervention and 4-weeks of high-intensity interval training~No intervention: No intervention~High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods"
11284088|NCT02858349|EG000|Reported Event|Arm 1|"4-week control period with no intervention and 4-weeks of high-intensity interval training~No intervention: No intervention~High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods"
11284089|NCT02858362|BG000|Baseline|Cohort 1: SMT C1100 Formulation 1|Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284090|NCT02858362|BG001|Baseline|Cohort 2: SMT C1100 Formulation 2|Participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284091|NCT02858362|BG002|Baseline|Cohort 3: SMT C1100 Formulation 1|Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284092|NCT02858362|BG003|Baseline|Total|Total of all reporting groups
11284093|NCT02858362|FG000|Participant Flow|Cohort 1: SMT C1100 Formulation 1|Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284094|NCT02858362|FG001|Participant Flow|Cohort 2: SMT C1100 Formulation 2|Participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284095|NCT02858362|FG002|Participant Flow|Cohort 3: SMT C1100 Formulation 1|Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284096|NCT02858362|OG000|Outcome|Cohorts 1 and 2: SMT C1100|Cohort 1 participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks. Cohort 2 participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284097|NCT02858362|OG000|Outcome|Cohort 1: SMT C1100 Formulation 1|Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284098|NCT02858362|OG001|Outcome|Cohort 2: SMT C1100 Formulation 2|Participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284099|NCT02858362|OG002|Outcome|Cohort 3: SMT C1100 Formulation 1|Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284100|NCT02858362|OG000|Outcome|Cohorts 1, 2 and 3: SMT C1100|Cohorts 1 and 3 participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks. Cohort 2 participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284101|NCT02858362|OG000|Outcome|Cohort 3: SMT C1100 Formulation 1|Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284102|NCT02858362|OG000|Outcome|Cohort 1, 2 and 3: SMT C1100|Cohorts 1 and 3 participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks. Cohort 2 participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284103|NCT02858362|OG000|Outcome|Cohorts 2 and 3 SMT C1100|Cohort 2 participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks. Cohort 3 participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284104|NCT02858362|EG000|Reported Event|Cohort 1: SMT C1100 Formulation 1|Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284105|NCT02858362|EG001|Reported Event|Cohort 2: SMT C1100 Formulation 2|Participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.
11284106|NCT02858362|EG002|Reported Event|Cohort 3: SMT C1100 Formulation 1|Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.
11284107|NCT02858401|BG000|Baseline|Vesatolimod 1 mg (Cohort 1)|Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284108|NCT02858401|BG001|Baseline|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284109|NCT02858401|BG002|Baseline|Vesatolimod 4 mg (Cohort 3)|Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284110|NCT02858401|BG003|Baseline|Vesatolimod 6 mg (Cohort 4)|Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284111|NCT02858401|BG004|Baseline|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284112|NCT02858401|BG005|Baseline|Vesatolimod 10 or 12 mg (Cohort 6)|Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284113|NCT02858401|BG006|Baseline|Placebo|Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284114|NCT02858401|BG007|Baseline|Total|Total of all reporting groups
11284115|NCT02858401|FG000|Participant Flow|Vesatolimod 1 mg (Cohort 1)|Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing antiretroviral (ARV) regimen in accordance with their prescribing information (the following agents were allowed: nucleoside/nucleotide reverse transcriptase inhibitors [NRTIs], raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284116|NCT02858401|FG001|Participant Flow|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284117|NCT02858401|FG002|Participant Flow|Vesatolimod 4 mg (Cohort 3)|Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284118|NCT02858401|FG003|Participant Flow|Vesatolimod 6 mg (Cohort 4)|Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284119|NCT02858401|FG004|Participant Flow|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284120|NCT02858401|FG005|Participant Flow|Vesatolimod 10 or 12 mg (Cohort 6)|Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to Day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284121|NCT02858401|FG006|Participant Flow|Placebo|Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284122|NCT02858401|OG000|Outcome|Vesatolimod 1 mg (Cohort 1)|Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284123|NCT02858401|OG001|Outcome|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284124|NCT02858401|OG002|Outcome|Vesatolimod 4 mg (Cohort 3)|Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284125|NCT02858401|OG003|Outcome|Vesatolimod 6 mg (Cohort 4)|Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284126|NCT02858401|OG004|Outcome|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284127|NCT02858401|OG005|Outcome|Vesatolimod 10 or 12 mg (Cohort 6)|Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284128|NCT02858401|OG006|Outcome|Placebo|Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284129|NCT02858401|OG000|Outcome|Vesatolimod 1 mg (Cohort 1)|Participants received vesatolimod 1 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284130|NCT02858401|OG001|Outcome|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284131|NCT02858401|OG002|Outcome|Vesatolimod 4 mg (Cohort 3)|Participants received vesatolimod 4 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284132|NCT02858401|OG003|Outcome|Vesatolimod 6 mg (Cohort 4)|Participants received vesatolimod 6 mg tablet orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284133|NCT02858401|OG004|Outcome|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg tablet following overnight fasting once every 2 weeks for 127 days for a total of 10 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284134|NCT02858401|OG005|Outcome|Vesatolimod 10 or 12 mg (Cohort 6)|Participants received vesatolimod 10 mg up to Day 43 for a total of 3 doses then vesatolimod 12 mg up to 12 mg for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284135|NCT02858401|OG006|Outcome|Placebo|Participants received vesatolimod placebo once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284136|NCT02858401|OG004|Outcome|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284137|NCT02858401|OG001|Outcome|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284138|NCT02858401|EG000|Reported Event|Vesatolimod 1 mg (Cohort 1)|Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284139|NCT02858401|EG001|Reported Event|Vesatolimod 2 mg (Cohort 2)|Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284140|NCT02858401|EG002|Reported Event|Vesatolimod 4 mg (Cohort 3)|Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284141|NCT02858401|EG003|Reported Event|Vesatolimod 6 mg (Cohort 4)|Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284142|NCT02858401|EG004|Reported Event|Vesatolimod 8 mg (Cohort 5)|Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284143|NCT02858401|EG005|Reported Event|Vesatolimod 10 or 12 mg (Cohort 6)|Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284144|NCT02858401|EG006|Reported Event|Placebo|Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
11284145|NCT02858440|BG000|Baseline|DTPa-IPV/Hib Group|All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
11284146|NCT02858440|FG000|Participant Flow|DTPa-IPV/Hib Group|All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
11284147|NCT02858440|OG000|Outcome|DTPa-IPV/Hib Group|All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
11284148|NCT02858440|EG000|Reported Event|DTPa-IPV/Hib Group|All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
11284149|NCT02858492|BG000|Baseline|Placebo BID|Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284150|NCT02858492|BG001|Baseline|Placebo TID|Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284151|NCT02858492|BG002|Baseline|GSK2982772 60 mg BID|Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284152|NCT02858492|BG003|Baseline|GSK2982772 60 mg TID|Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284153|NCT02858492|BG004|Baseline|Total|Total of all reporting groups
11284154|NCT02858492|FG000|Participant Flow|Placebo BID|Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284155|NCT02858492|FG001|Participant Flow|Placebo TID|Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284156|NCT02858492|FG002|Participant Flow|GSK2982772 60 mg BID|Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284157|NCT02858492|FG003|Participant Flow|GSK2982772 60 mg TID|Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284158|NCT02858492|OG000|Outcome|Placebo BID|Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284159|NCT02858492|OG001|Outcome|Placebo TID|Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284160|NCT02858492|OG002|Outcome|GSK2982772 60 mg BID|Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284161|NCT02858492|OG003|Outcome|GSK2982772 60 mg TID|Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284162|NCT02858492|OG000|Outcome|GSK2982772 60 mg BID|Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284163|NCT02858492|OG001|Outcome|GSK2982772 60 mg TID|Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284164|NCT02858492|EG000|Reported Event|Placebo BID|Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284165|NCT02858492|EG001|Reported Event|Placebo TID|Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284166|NCT02858492|EG002|Reported Event|GSK2982772 60mg BID|Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284167|NCT02858492|EG003|Reported Event|GSK2982772 60mg TID|Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
11284168|NCT02858713|BG000|Baseline|App as Intervention + Enstilar©|"Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.~Enstilar 0.005%-0.064% Topical Foam"
11284169|NCT02858713|BG001|Baseline|Conventional Instructions + Enstilar©|"Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.~Enstilar 0.005%-0.064% Topical Foam"
11284170|NCT02858713|BG002|Baseline|Total|Total of all reporting groups
11284171|NCT02858713|FG000|Participant Flow|App as Intervention + Enstilar©|"Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.~Enstilar 0.005%-0.064% Topical Foam"
11284172|NCT02858713|FG001|Participant Flow|Conventional Instructions + Enstilar©|"Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.~Enstilar 0.005%-0.064% Topical Foam"
11284173|NCT02858713|OG000|Outcome|App as Intervention + Enstilar©|"Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.~Enstilar 0.005%-0.064% Topical Foam"
11284174|NCT02858713|OG001|Outcome|Conventional Instructions + Enstilar©|"Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.~Enstilar 0.005%-0.064% Topical Foam"
11284175|NCT02858713|OG000|Outcome|Conventional Instructions + Enstilar©|Conventional Instructions + Enstilar© Changing from baseline to week 4
11284176|NCT02858713|OG001|Outcome|App as Intervention + Enstilar©|App as intervention + Enstilar© Changing from baseline to week 4
11284177|NCT02858713|OG000|Outcome|Conventional Instructions + Enstilar©|Conventional Instructions + Enstilar© arm changing in LS-PGA form baseline to week 26.
11284178|NCT02858713|OG001|Outcome|App + Enstilar©|App + Enstilar© arm changing in LS-PGA from baseline to week 26
11284179|NCT02858713|EG000|Reported Event|Conventional Instructions + App as Intervention + Enstilar©|"Information obtained baseline, week 4, 8 and 26.~Participants were treated with Enstilar© once daily when needed for 6 months"
11284180|NCT02858713|EG001|Reported Event|App as Intervention + Enstilar©|"Information obtained baseline, week 4, 8 and 26.~Participants were treated with Enstilar© once daily when needed for 6 months"
11284181|NCT02858726|BG000|Baseline|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
11284182|NCT02858726|BG001|Baseline|CR845 1 mcg/kg|"IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)~CR845 1 mcg/kg: IV medication delivered three times/week"
11284183|NCT02858726|BG002|Baseline|CR845 1.5mcg/kg|"IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 1.5mcg/kg: IV medication delivered three times/week"
11284184|NCT02858726|BG003|Baseline|Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
11284185|NCT02858726|BG004|Baseline|Total|Total of all reporting groups
11284186|NCT02858726|FG000|Participant Flow|CR845 0.5mcg/kg|IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
11284187|NCT02858726|FG001|Participant Flow|CR845 1 mcg/kg|IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)
11284188|NCT02858726|FG002|Participant Flow|CR845 1.5mcg/kg|IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)
11284189|NCT02858726|FG003|Participant Flow|Placebo|IV Placebo administered after each dialysis session (3 times/week)
11284190|NCT02858726|OG000|Outcome|CR845 0.5mcg/kg|IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
11284191|NCT02858726|OG001|Outcome|CR845 1 mcg/kg|IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)
11284192|NCT02858726|OG002|Outcome|CR845 1.5mcg/kg|IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)
11284193|NCT02858726|OG003|Outcome|Placebo|IV Placebo administered after each dialysis session (3 times/week)
11284194|NCT02858726|OG000|Outcome|CR845 0.5mcg/kg|"IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 0.5 mcg/kg: IV medication delivered three times/week"
11284195|NCT02858726|OG001|Outcome|CR845 1 mcg/kg|"IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)~CR845 1 mcg/kg: IV medication delivered three times/week"
11284196|NCT02858726|OG002|Outcome|CR845 1.5mcg/kg|"IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)~CR845 1.5mcg/kg: IV medication delivered three times/week"
11284197|NCT02858726|OG003|Outcome|Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
11284198|NCT02858726|EG000|Reported Event|CR845 0.5mcg/kg|IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
11284199|NCT02858726|EG001|Reported Event|CR845 1 mcg/kg|IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)
11284200|NCT02858726|EG002|Reported Event|CR845 1.5mcg/kg|IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)
11284201|NCT02858726|EG003|Reported Event|Placebo|"IV Placebo administered after each dialysis session (3 times/week)~Placebo: IV medication delivered three times/week"
11284202|NCT02859142|BG000|Baseline|Augmented Treatment|"12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling~Chantix (Varenicline): Administered according to FDA approved package insert directions~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284203|NCT02859142|BG001|Baseline|Standard Treatment|"12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling~Placebo (identical to Varenicline)~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284204|NCT02859142|BG002|Baseline|Total|Total of all reporting groups
11284205|NCT02859142|FG000|Participant Flow|Augmented Treatment|"Participants received 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.~Drug: Chantix (Varenicline) Administered according to FDA approved package insert directions~Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks~Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings."
11284206|NCT02859142|FG001|Participant Flow|Standard Treatment|"Participants received 12 weeks of Placebo along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.~Drug: Placebo (identical to Varenicline)~Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks~Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings."
11284207|NCT02859142|OG000|Outcome|Augmented Treatment|"12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling~Chantix (Varenicline): Administered according to FDA approved package insert directions~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284208|NCT02859142|OG001|Outcome|Standard Treatment|"12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling~Placebo (identical to Varenicline)~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284209|NCT02859142|EG000|Reported Event|Augmented Treatment|"12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling~Chantix (Varenicline): Administered according to FDA approved package insert directions~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284210|NCT02859142|EG001|Reported Event|Standard Treatment|"12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling~Placebo (identical to Varenicline)~NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions~Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits [pre-quit day (medication initiation date, study week -1) and quit day (study week 0)]."
11284211|NCT02859246|BG000|Baseline|Mucinex|"600 mg of Mucinex 2 times a day.~Mucinex®: Mucinex®"
11284212|NCT02859246|FG000|Participant Flow|Mucinex|"600 mg of Mucinex 2 times a day.~Mucinex®: Mucinex®"
11284213|NCT02859246|OG000|Outcome|Mucinex|600 mg of Mucinex 2 times a day
11284214|NCT02859246|OG000|Outcome|Mucinex|"600 mg of Mucinex 2 times a day.~Mucinex®: Mucinex®"
11284215|NCT02859246|EG000|Reported Event|Mucinex (Intervetiion)|600 mg of Mucinex, 2 times a day, for 4 weeks.
11284216|NCT02859324|BG000|Baseline|CC-122 2mg + Nivolumab|CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284217|NCT02859324|BG001|Baseline|CC-122 3mg + Nivolumab|CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284218|NCT02859324|BG002|Baseline|CC-122 4mg + Nivolumab|CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284219|NCT02859324|BG003|Baseline|Total|Total of all reporting groups
11284220|NCT02859324|FG000|Participant Flow|CC-122 2mg + Nivolumab|CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284221|NCT02859324|FG001|Participant Flow|CC-122 3mg + Nivolumab|CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284222|NCT02859324|FG002|Participant Flow|CC-122 4mg + Nivolumab|CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284223|NCT02859324|OG000|Outcome|CC-122 2mg + Nivolumab|CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284224|NCT02859324|OG001|Outcome|CC-122 3mg + Nivolumab|CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284225|NCT02859324|OG002|Outcome|CC-122 4mg + Nivolumab|CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11092432|NCT01539837|OG000|Outcome|Placebo|Feriprox placebo administered orally at the same dosing volume as the 20mg/kg/day feriprox per day
11092433|NCT01539837|OG001|Outcome|Deferiprone 20mg|20mg/kg/day deferiprone divided into two equal doses (morning and evening), every day for 6 months
11284226|NCT02859324|EG000|Reported Event|CC-122 2mg + Nivolumab|CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284227|NCT02859324|EG001|Reported Event|CC-122 3mg + Nivolumab|CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284228|NCT02859324|EG002|Reported Event|CC-122 4mg + Nivolumab|CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks.
11284229|NCT02859441|BG000|Baseline|E10030 and Ranibizumab|Intravitreal injections of E10030 and Ranibizumab
11284230|NCT02859441|FG000|Participant Flow|E10030 and Ranibizumab|Intravitreal injections of E10030 and Ranibizumab
11284231|NCT02859441|OG000|Outcome|E10030 and Ranibizumab|Intravitreal injections of E10030 and Ranibizumab
11284232|NCT02859441|OG000|Outcome|Visual Acuity at Baseline|Intravitreal injections of E10030 and Ranibizumab
11284233|NCT02859441|OG001|Outcome|Visual Acuity at Week 52|Intravitreal injections of E10030 and Ranibizumab
11284234|NCT02859441|OG002|Outcome|Mean Change in Visual Acuity at Week 52 From Baseline|Intravitreal injections of E10030 and Ranibizumab
11284235|NCT02859441|OG001|Outcome|Visual Acuity at Week 104|Intravitreal injections of E10030 and Ranibizumab
11284236|NCT02859441|OG002|Outcome|Mean Change in Visual Acuity at Week 104 From Baseline|Intravitreal injections of E10030 and Ranibizumab
11284237|NCT02859441|OG000|Outcome|Increase in Size of RCH|Intravitreal injections of E10030 and Ranibizumab
11284238|NCT02859441|OG001|Outcome|Decrease in Size of RCH|Intravitreal injections of E10030 and Ranibizumab
11284239|NCT02859441|OG002|Outcome|Mixed Change in Size of RCH|Intravitreal injections of E10030 and Ranibizumab
11284240|NCT02859441|OG003|Outcome|No Change in Size of RCH|Intravitreal injections of E10030 and Ranibizumab
11284241|NCT02859441|OG000|Outcome|Increased Exudation|Intravitreal injections of E10030 and Ranibizumab
11284242|NCT02859441|OG001|Outcome|Decreased Exudation|Intravitreal injections of E10030 and Ranibizumab
11284243|NCT02859441|OG002|Outcome|Mixed Change in Exudation|Intravitreal injections of E10030 and Ranibizumab
11284244|NCT02859441|OG003|Outcome|No Change in Exudation|Intravitreal injections of E10030 and Ranibizumab
11284245|NCT02859441|OG000|Outcome|Increased Change|Intravitreal injections of E10030 and Ranibizumab
11284246|NCT02859441|OG001|Outcome|Decreased Change|Intravitreal injections of E10030 and Ranibizumab
11284247|NCT02859441|OG002|Outcome|Mixed Change|Intravitreal injections of E10030 and Ranibizumab
11284248|NCT02859441|OG003|Outcome|No Change|Intravitreal injections of E10030 and Ranibizumab
11284249|NCT02859441|EG000|Reported Event|E10030 and Ranibizumab|Intravitreal injections of E10030 and Ranibizumab
11284250|NCT02859454|BG000|Baseline|Avelumab|"Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284251|NCT02859454|FG000|Participant Flow|Avelumab|"Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284252|NCT02859454|OG000|Outcome|Avelumab|"Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284253|NCT02859454|OG000|Outcome|All Participants at Baseline|"All participants Voice Handicap Index-10 Score at Baseline.~Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses. Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284254|NCT02859454|OG001|Outcome|All Participants at 6 Weeks|"All participants Voice Handicap Index-10 Score at 6 Weeks.~Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284255|NCT02859454|OG002|Outcome|All Participants at 12 Weeks|"All participants Voice Handicap Index-10 Score at 12 Weeks.~Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284256|NCT02859454|EG000|Reported Event|Avelumab|"Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.~Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses."
11284257|NCT02859597|BG000|Baseline|High Flow Nasal Cannula|"High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284258|NCT02859597|BG001|Baseline|Nasal Cannula|"Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284259|NCT02859597|BG002|Baseline|Total|Total of all reporting groups
11284260|NCT02859597|FG000|Participant Flow|High Flow Nasal Cannula|"High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284261|NCT02859597|FG001|Participant Flow|Nasal Cannula|"Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284262|NCT02859597|OG000|Outcome|High Flow Nasal Canula|"High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284263|NCT02859597|OG001|Outcome|Nasal Canula|"Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284264|NCT02859597|OG000|Outcome|High Flow Nasal Cannula|"High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284265|NCT02859597|OG001|Outcome|Nasal Cannula|"Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284266|NCT02859597|EG000|Reported Event|High Flow Nasal Cannula|"High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284267|NCT02859597|EG001|Reported Event|Nasal Cannula|"Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.~High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation."
11284268|NCT02860130|BG000|Baseline|Prismocitrate 18|CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284269|NCT02860130|BG001|Baseline|No Systemic Anticoagulation|CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284270|NCT02860130|BG002|Baseline|Total|Total of all reporting groups
11284271|NCT02860130|FG000|Participant Flow|Prismocitrate 18|CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284272|NCT02860130|FG001|Participant Flow|No Systemic Anticoagulation|CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284273|NCT02860130|OG000|Outcome|Prismocitrate 18|CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284274|NCT02860130|OG001|Outcome|No Systemic Anticoagulation|CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284275|NCT02860130|EG000|Reported Event|Prismocitrate 18|CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284276|NCT02860130|EG001|Reported Event|No Systemic Anticoagulation|CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
11284277|NCT02860286|BG000|Baseline|Part 1 (Pharmacokenitc)|Subjects enrolled in Part 1were to receive a single 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was to be administered at a dose of 800 mg twice daily. PK blood samples were to be collected after administration of a single dose of 800 mg tazemetostat on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Plasma samples were to be analyzed for tazemetostat after each set of 6 subjects completed the PK sampling procedures on Cycle 1 Day 15.
11284278|NCT02860286|BG001|Baseline|Part 2 (Efficacy)|"In Part 2, subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1.~A 2-stage Green-Dahlberg design was utilized with a stopping rule to allow early termination at the end of Stage 1 if there was strong evidence of lack of efficacy based on results from the first 30 treated subjects who completed at least the 12-week assessment, completed the final study visit, or terminated early from the study, whichever was sooner. If early stopping criteria were met, enrollment was to be stopped. To avoid disruptions in the study, enrollment and treatment of subjects were not halted in order to conduct the interim analysis."
11284279|NCT02860286|BG002|Baseline|Total|Total of all reporting groups
11284280|NCT02860286|FG000|Participant Flow|Part 1 (Pharmacokinetics)|Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.
11284281|NCT02860286|FG001|Participant Flow|Part 2 (Efficacy)|subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1.
11284282|NCT02860286|OG000|Outcome|Part 1 (Pharmacokinetics)|Assessment of pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
11284283|NCT02860286|OG000|Outcome|Part 1 (Pharmacokinetics)|Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.
11284284|NCT02860286|OG000|Outcome|Part 1(Pharmacokinetics)|"Oral Tazemetostat 800mg BID~Tazemetostat: Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene."
11284285|NCT02860286|OG000|Outcome|Part 2|Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma.
11284286|NCT02860286|OG000|Outcome|Part 1|Subjects with relapsed orrefractory malignantmesothelioma regardless ofBAP1 status were to be treatedand PK blood samplescollected after a singletazemetostat 800 mg dose onCycle 1 Day 1 and afterrepeated twice daily doses oftazemetostat 800 mg on Cycle1 Day 15. Subjects were toreceive a single oral 800 mgtazemetostat dose on Cycle 1Day 1. Starting on Cycle 1 Day2, tazemetostat was orallyadministered at a dose of 800mg twice daily.
11284287|NCT02860286|OG001|Outcome|Part 2|Subjects with BAP1-deficientrelapsed or refractorymalignant mesothelioma wereto receive orally administeredtazemetostat 800 mg twicedaily starting on Cycle 1 Day1
11284288|NCT02860286|OG000|Outcome|Part 1|Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
11284289|NCT02860286|OG001|Outcome|Part 2|Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
11284290|NCT02860286|OG000|Outcome|Part 1|"Part 1 - Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status~Part 2: Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma"
11284291|NCT02860286|OG000|Outcome|Part 1|Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu
11284292|NCT02860286|OG000|Outcome|Part|Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
11284293|NCT02860286|EG000|Reported Event|Part 1 (Pharmacokinetics)|Assessed the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
11284294|NCT02860286|EG001|Reported Event|Part 2 (Efficacy)|To assess disease control rate (DCR) at 12 weeks (consisting of complete response [CR], partial response [PR], or stable disease [SD]) according to modified RECIST (Nowak, 2005) for thoracic disease or RECIST 1.1 elsewhere in subjects with relapsed or refractory BAP1-deficient malignant mesothelioma treated with tazemetostat
11284295|NCT02860507|BG000|Baseline|Neostigmine + Glycopyrrolate|"Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv~Neostigmine~Glycopyrrolate"
11284296|NCT02860507|BG001|Baseline|Sugammadex|"Sugammadex 4mg/kg~sugammadex"
11284297|NCT02860507|BG002|Baseline|Total|Total of all reporting groups
11284298|NCT02860507|FG000|Participant Flow|Neostigmine + Glycopyrrolate|"Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv~Neostigmine~Glycopyrrolate"
11284299|NCT02860507|FG001|Participant Flow|Sugammadex|"Sugammadex 4mg/kg~sugammadex"
11284300|NCT02860507|OG000|Outcome|Neostigmine + Glycopyrrolate|"Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv~Neostigmine~Glycopyrrolate"
11284301|NCT02860507|OG001|Outcome|Sugammadex|"Sugammadex 4mg/kg~sugammadex"
11284302|NCT02860507|EG000|Reported Event|Neostigmine + Glycopyrrolate|"Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv~Neostigmine~Glycopyrrolate"
11284303|NCT02860507|EG001|Reported Event|Sugammadex|"Sugammadex 4mg/kg~sugammadex"
11284304|NCT02860546|BG000|Baseline|TAS-102 + Nivolumab|Participants received a dose of 35 mg/m^2 of TAS-102 tablets orally BID within 1 hour after completion of morning and evening meals, in 4-week cycle. In each 4-week cycle, TAS-102 was administered for 2 weeks, as 5 days a week with 2 days rest, followed by a 14-day rest. Also participants received 3 mg/kg/dose Nivolumab I.V infusion over 60 minutes every 14 days (on Day 1 and Day 15 of each 4-week cycle).
11284305|NCT02860546|FG000|Participant Flow|TAS-102 + Nivolumab|Participants received a dose of 35 milligrams per meter square (mg/m^2) of TAS-102 tablets orally twice per day (BID) within 1 hour after completion of morning and evening meals, in 4-week cycle. In each 4-week cycle, TAS-102 was administered for 2 weeks, as 5 days a week with 2 days rest, followed by a 14-day rest. Also participants received 3 milligrams per kilogram per dose (mg/kg/dose) Nivolumab intravenous (I.V) infusion over 60 minutes every 14 days (on Day 1 and Day 15 of each 4-week cycle).
11284306|NCT02860546|OG000|Outcome|TAS-102 + Nivolumab|Participants received a dose of 35 mg/m^2 of TAS-102 tablets orally BID within 1 hour after completion of morning and evening meals, in 4-week cycle. In each 4-week cycle, TAS-102 was administered for 2 weeks, as 5 days a week with 2 days rest, followed by a 14-day rest. Also participants received 3 mg/kg/dose Nivolumab I.V infusion over 60 minutes every 14 days (on Day 1 and Day 15 of each 4-week cycle).
11284307|NCT02860546|EG000|Reported Event|TAS-102 + Nivolumab|Participants received a dose of 35 mg/m^2 of TAS-102 tablets orally BID within 1 hour after completion of morning and evening meals, in 4-week cycle. In each 4-week cycle, TAS-102 was administered for 2 weeks, as 5 days a week with 2 days rest, followed by a 14-day rest. Also participants received 3 mg/kg/dose Nivolumab I.V infusion over 60 minutes every 14 days (on Day 1 and Day 15 of each 4-week cycle).
11284308|NCT02860845|BG000|Baseline|Boric Acid and Probiotics|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284309|NCT02860845|BG001|Baseline|Antibiotic/Antifungal|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284310|NCT02860845|BG002|Baseline|Total|Total of all reporting groups
11284311|NCT02860845|FG000|Participant Flow|Boric Acid and Probiotics|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284312|NCT02860845|FG001|Participant Flow|Antibiotic/Antifungal|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284313|NCT02860845|OG000|Outcome|Boric Acid and Probiotics Baseline|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284314|NCT02860845|OG001|Outcome|Antibiotic/Antifungal Baseline|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284315|NCT02860845|OG002|Outcome|Boric Acid and Probiotics Visit 1|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284316|NCT02860845|OG003|Outcome|Antibiotic/Antifungal Visit 1|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284317|NCT02860845|OG000|Outcome|Boric Acid and Probiotics|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284318|NCT02860845|OG001|Outcome|Antibiotic/Antifungal|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284319|NCT02860845|EG000|Reported Event|Boric Acid and Probiotics|"Boric acid with L.gasseri and L.rhamnosus~Boric acid and probiotics: Vaginal capsules administered once a day during 7 days."
11284320|NCT02860845|EG001|Reported Event|Antibiotic/Antifungal|"Antibiotic: Clindamicine Antifungal: Clotrimazol~Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.~Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days."
11284321|NCT02860988|BG000|Baseline|MCCC Treatment|Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
11284322|NCT02860988|BG001|Baseline|MCCC Comparison|Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships.
11284323|NCT02860988|BG002|Baseline|Total|Total of all reporting groups
11284324|NCT02860988|FG000|Participant Flow|MCCC Treatment|Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
11284325|NCT02860988|FG001|Participant Flow|MCCC Comparison|Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships.
11284326|NCT02860988|OG000|Outcome|MCCC Treatment|Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
11284327|NCT02860988|OG001|Outcome|MCCC Comparison|Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships.
11284328|NCT02860988|EG000|Reported Event|MCCC Treatment|Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
11284329|NCT02860988|EG001|Reported Event|MCCC Comparison|Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships.
11284330|NCT02861118|BG000|Baseline|Cohort 1: Crohn's Disease|Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
11284331|NCT02861118|BG001|Baseline|Cohort 2: Ulcerative Colitis|Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
11284332|NCT02861118|BG002|Baseline|Total|Total of all reporting groups
11284333|NCT02861118|FG000|Participant Flow|Cohort 1: Crohn's Disease|Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
11284334|NCT02861118|FG001|Participant Flow|Cohort 2: Ulcerative Colitis|Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
11284335|NCT02861118|OG000|Outcome|Participants With Inflammatory Bowel Disease (IBD)|Participants with IBD (Crohn's disease and ulcerative colitis) who received biological treatment between June 2011 and June 2013.
11284336|NCT02861118|OG000|Outcome|Cohort 1: Crohn's Disease|Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
11284337|NCT02861118|OG001|Outcome|Cohort 2: Ulcerative Colitis|Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
11284338|NCT02861118|OG000|Outcome|Cohort 2: Ulcerative Colitis|Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
11284339|NCT02861118|EG000|Reported Event|Cohort 1: Crohn's Disease|Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
11284340|NCT02861118|EG001|Reported Event|Cohort 2: Ulcerative Colitis|Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
11284341|NCT02861131|BG000|Baseline|Sugammadex|"Sugammadex 2 mg/kg IV once at the end of surgery~Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow"
11284342|NCT02861131|BG001|Baseline|Neostigmine|"Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery~Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered."
11284343|NCT02861131|BG002|Baseline|Total|Total of all reporting groups
11284344|NCT02861131|FG000|Participant Flow|Sugammadex|"Sugammadex 2 mg/kg IV once at the end of surgery~Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow"
11284345|NCT02861131|FG001|Participant Flow|Neostigmine|"Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery~Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered."
11284346|NCT02861131|OG000|Outcome|Sugammadex|"Sugammadex 2 mg/kg IV once at the end of surgery~Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow"
11284347|NCT02861131|OG001|Outcome|Neostigmine|"Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery~Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered."
11284348|NCT02861131|EG000|Reported Event|Sugammadex|"Sugammadex 2 mg/kg IV once at the end of surgery~Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow"
11284349|NCT02861131|EG001|Reported Event|Neostigmine|"Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery~Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered."
11284350|NCT02861534|BG000|Baseline|Vericiguat|Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of heart failure (HF) standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
11284351|NCT02861534|BG001|Baseline|Placebo|Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
10970606|NCT00911157|EG000|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
11284352|NCT02861534|BG002|Baseline|Total|Total of all reporting groups
11284353|NCT02861534|FG000|Participant Flow|Vericiguat|Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of heart failure (HF) standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
11284354|NCT02861534|FG001|Participant Flow|Placebo|Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
11284355|NCT02861534|OG000|Outcome|Vericiguat|Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
11284356|NCT02861534|OG001|Outcome|Placebo|Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
11284357|NCT02861534|EG000|Reported Event|Vericiguat|Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
11284358|NCT02861534|EG001|Reported Event|Placebo|Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
11092434|NCT01539837|OG002|Outcome|Deferiprone 30mg|30mg/kg/day Deferiprone divided into two equal doses (morning and evening), every day for 6 months
11092435|NCT01539837|EG000|Reported Event|Placebo|Feriprox placebo administered orally at the same dosing volume as the 20mg/kg/day feriprox per day
11284359|NCT02861586|BG000|Baseline|Treatment Group A; MV-CHIK Low|Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284360|NCT02861586|BG001|Baseline|Treatment Group A/C; Priorix®|Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284361|NCT02861586|BG002|Baseline|Treatment Group B; MV-CHIK Low|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284362|NCT02861586|BG003|Baseline|Treatment Group B/D; Priorix®|Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284363|NCT02861586|BG004|Baseline|Treatment Group C; MV-CHIK High|Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284364|NCT02861586|BG005|Baseline|Treatment Group D; MV-CHIK High|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284365|NCT02861586|BG006|Baseline|Measles Booster Group 1|Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284366|NCT02861586|BG007|Baseline|Measles Booster Group 2|Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284367|NCT02861586|BG008|Baseline|Total|Total of all reporting groups
11284368|NCT02861586|FG000|Participant Flow|Treatment Group A; MV-CHIK Low|Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284369|NCT02861586|FG001|Participant Flow|Treatment Group A/C; Priorix®|Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284370|NCT02861586|FG002|Participant Flow|Treatment Group B; MV-CHIK Low|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284371|NCT02861586|FG003|Participant Flow|Treatment Group B/D; Priorix®|Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284372|NCT02861586|FG004|Participant Flow|Treatment Group C; MV-CHIK High|Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284373|NCT02861586|FG005|Participant Flow|Treatment Group D; MV-CHIK High|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284374|NCT02861586|FG006|Participant Flow|Measles Booster Group 1|Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284375|NCT02861586|FG007|Participant Flow|Measles Booster Group 2|Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284376|NCT02861586|OG000|Outcome|Treatment Group A; MV-CHIK Low|Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284377|NCT02861586|OG001|Outcome|Treatment Group A/C; Priorix®|Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284378|NCT02861586|OG002|Outcome|Treatment Group B; MV-CHIK Low|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284379|NCT02861586|OG003|Outcome|Treatment Group B/D; Priorix®|Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284380|NCT02861586|OG004|Outcome|Treatment Group C; MV-CHIK High|Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284381|NCT02861586|OG005|Outcome|Treatment Group D; MV-CHIK High|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284382|NCT02861586|OG006|Outcome|Measles Booster Group 1|Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284383|NCT02861586|OG007|Outcome|Measles Booster Group 2|Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284384|NCT02861586|OG002|Outcome|Treatment Group B; MV-CHIK Low|Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284385|NCT02861586|OG000|Outcome|Baseline Measles Titer Percentile 0 to 25%|Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value.
11284386|NCT02861586|OG001|Outcome|Baseline Measles Titer Percentile 25 to 50%|Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value.
11284387|NCT02861586|OG002|Outcome|Baseline Measles Titer Percentile 50 to 75%|Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value.
11284388|NCT02861586|OG003|Outcome|Baseline Measles Titer Percentile 75 to 100%|Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value.
11284389|NCT02861586|EG000|Reported Event|Treatment Group A; MV-CHIK Low|Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11092436|NCT01539837|EG001|Reported Event|Deferiprone 20mg|20mg/kg/day deferiprone divided into two equal doses (morning and evening), every day for 6 months
11092437|NCT01539837|EG002|Reported Event|Deferiprone 30mg|30mg/kg/day Deferiprone divided into two equal doses (morning and evening), every day for 6 months
11284390|NCT02861586|EG001|Reported Event|Treatment Group A/C; Priorix®|Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284391|NCT02861586|EG002|Reported Event|Treatment Group B; MV-CHIK Low|Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284392|NCT02861586|EG003|Reported Event|Treatment Group B/D; Priorix®|Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284393|NCT02861586|EG004|Reported Event|Treatment Group C; MV-CHIK High|Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284394|NCT02861586|EG005|Reported Event|Treatment Group D; MV-CHIK High|Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284395|NCT02861586|EG006|Reported Event|Measles Booster Group 1|Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284396|NCT02861586|EG007|Reported Event|Measles Booster Group 2|Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
11284397|NCT02861664|BG000|Baseline|Test Dentifrice: Stannous Fluoride (SnF2)|Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284398|NCT02861664|BG001|Baseline|Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)|Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284399|NCT02861664|BG002|Baseline|Total|Total of all reporting groups
11284400|NCT02861664|FG000|Participant Flow|Test Dentifrice: Stannous Fluoride (SnF2)|Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284401|NCT02861664|FG001|Participant Flow|Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)|Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284402|NCT02861664|OG000|Outcome|Test Dentifrice: Stannous Fluoride (SnF2)|Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284403|NCT02861664|OG001|Outcome|Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)|Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284404|NCT02861664|EG000|Reported Event|Test Dentifrice: Stannous Fluoride (SnF2)|Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
11284405|NCT02861664|EG001|Reported Event|Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)|Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as SMFP to cover the head of the toothbrush and brush with assigned dentifrice twice daily (morning and evening) for 1 timed minute. Participants were permitted to rinse with tap water.
11284406|NCT02861807|BG000|Baseline|Active Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to 2.0 milliamps (mA) and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284407|NCT02861807|BG001|Baseline|Sham Brain Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to ramp up to 2.0 milliamps (mA) and then ramp down to 0.0 mA and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284408|NCT02861807|BG002|Baseline|Total|Total of all reporting groups
11284409|NCT02861807|FG000|Participant Flow|Active Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to 2.0 milliamps (mA) and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284410|NCT02861807|FG001|Participant Flow|Sham Brain Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to ramp up to 2.0 milliamps (mA) and then ramp down to 0.0 mA and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284411|NCT02861807|OG000|Outcome|Active Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to 2.0 milliamps (mA) and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284412|NCT02861807|OG001|Outcome|Sham Brain Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to ramp up to 2.0 milliamps (mA) and then ramp down to 0.0 mA and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284413|NCT02861807|EG000|Reported Event|Active Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to 2.0 milliamps (mA) and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284414|NCT02861807|EG001|Reported Event|Sham Brain Stimulation With Mindfulness|"Brain stimulation with mindfulness-based relapse prevention. Treatment sessions will be 2 hours for 8 sessions, with the first 30 minutes consisting of transcranial direct current stimulation (tDCS) with the current set to ramp up to 2.0 milliamps (mA) and then ramp down to 0.0 mA and guided meditation practice.~Brain stimulation with mindfulness-based relapse prevention: Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice."
11284415|NCT02861937|BG000|Baseline|Group I (Control Group): Healthy|Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
11284416|NCT02861937|BG001|Baseline|Group II (Test Group I): Chronic Gingivitis|"Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP)~Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy~non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene."
11284417|NCT02861937|BG002|Baseline|Group III (Test Group II): Chronic Periodontitis|"Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically.~Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy~non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene."
11284418|NCT02861937|BG003|Baseline|Total|Total of all reporting groups
11284419|NCT02861937|FG000|Participant Flow|Group I (Control Group): Healthy|Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
11284420|NCT02861937|FG001|Participant Flow|Group II (Test Group I): Chronic Gingivitis|Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
11284421|NCT02861937|FG002|Participant Flow|Group III (Test Group II): Chronic Periodontitis|Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
11284422|NCT02861937|OG000|Outcome|Group I (Control Group)|Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
11284423|NCT02861937|OG001|Outcome|Group II (Test Group I)|Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
11284424|NCT02861937|OG002|Outcome|Group III (Test Group II)|Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
11284425|NCT02861937|OG001|Outcome|Group II (Test Group I)|Twelve chronic gingivitis patients having probing depth less than or equal to 4mm, with no Relative Attachment loss (RAL)and with more than 25% of sites with gingival bleeding present.
11284426|NCT02861937|EG000|Reported Event|Group I (Control Group)|Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
11284427|NCT02861937|EG001|Reported Event|Group II (Test Group I)|Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
11284428|NCT02861937|EG002|Reported Event|Group III (Test Group II)|Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
11284429|NCT02862080|BG000|Baseline|Ekso Alone, and Ekso + Cathode tsDCS|"Participants received Ekso alone and also Ekso combined with cathode non-invasive transcutaneous spinal direct current stimulation (tsDCS).~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso alone will consist of a walking session in Ekso with no tsDCS. Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso."
11092438|NCT01539980|BG000|Baseline|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
11284430|NCT02862080|BG001|Baseline|Ekso Alone, and Ekso + Anode tsDCS|"Participants received Ekso alone and also Ekso combined with anode non-invasive transcutaneous spinal direct current stimulation (tsDCS).~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso alone will consist of a walking session in Ekso with no tsDCS. Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso."
11284431|NCT02862080|BG002|Baseline|Total|Total of all reporting groups
11284432|NCT02862080|FG000|Participant Flow|no Intervention; Then no Intervention; Then Cathode tsDCS + Ekso; Then Ekso; Then Cathode tsDCS+Ekso|"Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.~cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking."
11284433|NCT02862080|FG001|Participant Flow|no Intervention; Then no Intervention; Then Ekso; Then Cathode tsDCS + Ekso; Then Ekso|"Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.~cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking."
11284434|NCT02862080|FG002|Participant Flow|no Intervention; Then no Intervention; Then Anode tsDCS + Ekso; Then Ekso; Then Anode tsDCS + Ekso|"Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.~Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin."
11284435|NCT02862080|FG003|Participant Flow|no Intervention; Then no Intervention; Then Ekso; Then Anode tsDCS + Ekso; Then Ekso|"Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.~Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.~Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin."
11284436|NCT02862080|OG000|Outcome|No Intervention|Neither Ekso nor tsDCS are applied.
11284437|NCT02862080|OG000|Outcome|Cathode tsDCS + Ekso|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso."
11284438|NCT02862080|OG001|Outcome|Anode tsDCS + Ekso|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso."
11284439|NCT02862080|OG002|Outcome|Ekso Alone|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Ekso alone will consist of a walking session in Ekso with no tsDCS."
11284440|NCT02862080|EG000|Reported Event|Cathode tsDCS + Ekso|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso."
11284441|NCT02862080|EG001|Reported Event|Anode tsDCS + Ekso|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.~Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso."
11284442|NCT02862080|EG002|Reported Event|Ekso Alone|"Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.~Ekso alone will consist of a walking session in Ekso with no tsDCS."
11284443|NCT02862080|EG003|Reported Event|No Intervention|Neither Ekso nor tsDCS are applied.
11284444|NCT02862106|BG000|Baseline|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284445|NCT02862106|BG001|Baseline|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284446|NCT02862106|BG002|Baseline|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284447|NCT02862106|BG003|Baseline|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284448|NCT02862106|BG004|Baseline|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11092439|NCT01539980|FG000|Participant Flow|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
11284449|NCT02862106|BG005|Baseline|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284450|NCT02862106|BG006|Baseline|Total|Total of all reporting groups
11284451|NCT02862106|FG000|Participant Flow|εPA-44 900μg|"Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128~εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128"
11284452|NCT02862106|FG001|Participant Flow|Follow-up Group|Do not give any intervention, follow-up observation only
11284453|NCT02862106|OG000|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284454|NCT02862106|OG001|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284455|NCT02862106|OG002|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
11284456|NCT02862106|OG003|Outcome|εPA-44 900μg Group-placebo|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284457|NCT02862106|OG004|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284458|NCT02862106|OG005|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284459|NCT02862106|OG003|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284460|NCT02862106|OG004|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
11284461|NCT02862106|EG000|Reported Event|Follow-up Group|Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population
11284462|NCT02862106|EG001|Reported Event|εPA-44 900μg Group|Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population
11284463|NCT02862535|BG000|Baseline|Cohort 1: ADX|Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284464|NCT02862535|BG001|Baseline|Cohort 2: ADX+S-1+Cisplatin|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label.
11284465|NCT02862535|BG002|Baseline|Cohort 3: ADX+S-1+Oxaliplatin|Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.
11284466|NCT02862535|BG003|Baseline|Cohort 4: ADX+Nivolumab|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284467|NCT02862535|BG004|Baseline|Total|Total of all reporting groups
11284468|NCT02862535|FG000|Participant Flow|Cohort 1: ADX|Participants received andecaliximab (ADX) 800 mg as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284469|NCT02862535|FG001|Participant Flow|Cohort 2: ADX + S-1 + Cisplatin|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label.
11284470|NCT02862535|FG002|Participant Flow|Cohort 3: ADX + S-1 + Oxaliplatin|Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.
11284471|NCT02862535|FG003|Participant Flow|Cohort 4: ADX + Nivolumab|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284472|NCT02862535|OG000|Outcome|Cohort 1: ADX|Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284473|NCT02862535|OG001|Outcome|Cohort 2: ADX + S-1 + Cisplatin|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label.
11284474|NCT02862535|OG002|Outcome|Cohort 3: ADX + S-1 + Oxaliplatin|Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.
11284475|NCT02862535|OG003|Outcome|Cohort 4: ADX + Nivolumab|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284476|NCT02862535|EG000|Reported Event|Cohort 1: ADX|Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11284477|NCT02862535|EG001|Reported Event|Cohort 2: ADX + S-1 + Cisplatin|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label.
11284478|NCT02862535|EG002|Reported Event|Cohort 3: ADX + S-1 + Oxaliplatin|Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.
11284479|NCT02862535|EG003|Reported Event|Cohort 4: ADX + Nivolumab|Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
11287160|NCT02898662|EG001|Reported Event|Placebo|Participants received placebo for inhalation via nebuliser solution (up to 13 doses). All participants received placebo to match 4 mg AZD1419 once weekly for 4 doses. The following 9 doses were adapted based on tolerability (severity of flu-like symptoms). Participants were prescribed their usual controller medication (ICS + LABA) in separate inhalers. During the dosing period, controller medications were gradually reduced and discontinued. Treatment was initiated with 6 doses of placebo on top of the participant's controller medication, LABA was then stopped on the evening prior to receiving dose 7, and ICS was gradually tapered down and discontinued during the next 3 weeks before being discontinued in the evening prior to receiving placebo dose 10.
11287161|NCT02898740|BG000|Baseline|Exercise|Structural exercise: Exercise instruction and encouragement
11287162|NCT02898740|BG001|Baseline|Health Education|Health education: Provision of general information about a variety of health topics
11287163|NCT02898740|BG002|Baseline|Total|Total of all reporting groups
11287164|NCT02898740|FG000|Participant Flow|Exercise|Structural exercise: Exercise instruction and encouragement
11284480|NCT02862574|BG000|Baseline|Andecaliximab 300 mg|"Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284481|NCT02862574|BG001|Baseline|Andecaliximab 150 mg|"Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284482|NCT02862574|BG002|Baseline|Placebo|"Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284483|NCT02862574|BG003|Baseline|Total|Total of all reporting groups
11284484|NCT02862574|FG000|Participant Flow|Andecaliximab 300 mg|"Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a tumor necrosis factor (TNF) inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284485|NCT02862574|FG001|Participant Flow|Andecaliximab 150 mg|"Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284486|NCT02862574|FG002|Participant Flow|Placebo|"Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate~Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate"
11284487|NCT02862574|OG000|Outcome|Andecaliximab 300 mg|Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284488|NCT02862574|OG001|Outcome|Andecaliximab 150 mg|Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284489|NCT02862574|OG002|Outcome|Placebo|Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284490|NCT02862574|EG000|Reported Event|Andecaliximab 300 mg (Double-Blind)|Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284491|NCT02862574|EG001|Reported Event|Andecaliximab 150 mg (Double-Blind)|Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284492|NCT02862574|EG002|Reported Event|Placebo (Double-Blind)|Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284493|NCT02862574|EG003|Reported Event|Andecaliximab 300 mg (Open-Label)|Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
11284494|NCT02862600|BG000|Baseline|Perhexiline|"Perhexiline will be administered orally. Dosing will be determined based on plasma level monitoring. For the first 8 week period, the target range will be 100-300 ng/mL, for the second 8 week period, the target range will be 300-500 ng/mL.~Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline~Use of bioanalytical assay to monitor plasma levels of perhexiline: The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline."
11284495|NCT02862600|FG000|Participant Flow|Perhexiline|Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline
11284496|NCT02862600|OG000|Outcome|Perhexiline--16 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml, and an additional 8 weeks of perhexiline at target range 300-500 ng/ml.
11284497|NCT02862600|OG000|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml.
11284498|NCT02862600|OG000|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml
11284499|NCT02862600|EG000|Reported Event|Perhexiline|All enrolled subjects
11284500|NCT02862730|BG000|Baseline|All Study Participants|All study participants were randomized to complete four 84 hour study visits using either standard of care insulin pump therapy, dual hormone, single hormone or predictive low glucose suspend closed loop control. Treatment order was randomized.
11284501|NCT02862730|FG000|Participant Flow|SAP, PLGS, DH, SH|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
11284502|NCT02862730|FG001|Participant Flow|SAP, DH, SH, PLGS|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
11284503|NCT02862730|FG002|Participant Flow|DH, SH, SAP, PLGS|The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH), open loop (Sensor Augmented Pump SAP), and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions.
11284504|NCT02862730|FG003|Participant Flow|SH, SAP, PLGS, DH|The randomization order for subjects in this arm was single hormone (SH), open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
11284505|NCT02862730|FG004|Participant Flow|PLGS, DH, SH, SAP|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH), single hormone (SH), and open loop (Sensor Augmented Pump SAP). Each visit was 84 hours and included inpatient and outpatient portions.
11284506|NCT02862730|FG005|Participant Flow|PLGS, SAP, SH, DH|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), open loop (Sensor Augmented Pump SAP), single hormone (SH), and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions.
11284507|NCT02862730|FG006|Participant Flow|SAP, DH, PLGS, SH|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions.
11284508|NCT02862730|OG000|Outcome|Predictive Low Glucose Suspend Arm|"The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.~Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery command"
11284509|NCT02862730|OG001|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled
11284510|NCT02862730|OG002|Outcome|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
11284511|NCT02862730|OG003|Outcome|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
11284512|NCT02862730|OG000|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
11284513|NCT02862730|OG001|Outcome|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
11284514|NCT02862730|OG000|Outcome|Dual Hormone Closed Loop|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon
11284515|NCT02862730|OG001|Outcome|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
11287165|NCT02898740|FG001|Participant Flow|Health Education|Health education: Provision of general information about a variety of health topics
11287166|NCT02898740|OG000|Outcome|Exercise|Structural exercise: Exercise instruction and encouragement
11287167|NCT02898740|OG001|Outcome|Health Education|Health education: Provision of general information about a variety of health topics
11287168|NCT02898740|EG000|Reported Event|Exercise|Structural exercise: Exercise instruction and encouragement
11284516|NCT02862730|EG000|Reported Event|Predictive Low Glucose Suspend Arm|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
11284517|NCT02862730|EG001|Reported Event|Dual Hormone Closed-loop Arm|Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
11284518|NCT02862730|EG002|Reported Event|Single Hormone Closed-loop Arm|Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
11284519|NCT02862730|EG003|Reported Event|Sensor Augmented Pump Therapy Arm|"Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.~Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would."
11284520|NCT02862730|EG004|Reported Event|Tslim Training|Subjects used the tslim and Dexcom G4 Share of G5 sensor for two weeks at home to allow subjects to become familiar with the devices.
11284521|NCT02862912|BG000|Baseline|Chloroprocaine (CP)|"Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)~Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups"
11284522|NCT02862912|BG001|Baseline|Bupivacaine (BUP)|"Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml~Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups~Saline: Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml"
11284523|NCT02862912|BG002|Baseline|Total|Total of all reporting groups
11284524|NCT02862912|FG000|Participant Flow|Chloroprocaine (CP)|"Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)~Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups"
11284525|NCT02862912|FG001|Participant Flow|Bupivacaine (BUP)|"Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml~Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups~Saline: Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml"
11284526|NCT02862912|OG000|Outcome|Chloroprocaine (CP)|"Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)~Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups"
11284527|NCT02862912|OG001|Outcome|Bupivacaine (BUP)|"Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml~Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups~Saline: Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml"
11284528|NCT02862912|OG000|Outcome|Bupivacaine (BUP)|"Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml~Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups~Saline: Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml"
11284529|NCT02862912|OG001|Outcome|Chloroprocaine (CP)|"Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)~Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups"
11284530|NCT02862912|EG000|Reported Event|Chloroprocaine (CP)|"Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)~Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups"
11284531|NCT02862912|EG001|Reported Event|Bupivacaine (BUP)|"Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml~Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)~Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups~Saline: Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml"
11287169|NCT02898740|EG001|Reported Event|Health Education|Health education: Provision of general information about a variety of health topics
11284532|NCT02863198|BG000|Baseline|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
11284533|NCT02863198|BG001|Baseline|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
11284534|NCT02863198|BG002|Baseline|Total|Total of all reporting groups
11284535|NCT02863198|FG000|Participant Flow|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
11284536|NCT02863198|FG001|Participant Flow|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
11284537|NCT02863198|OG000|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
11284538|NCT02863198|OG001|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
11284539|NCT02863198|EG000|Reported Event|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
11284540|NCT02863198|EG001|Reported Event|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
11284541|NCT02863263|BG000|Baseline|Foam Dressing|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms."
11284542|NCT02863263|BG001|Baseline|Foam Dressing With Povidone Iodine|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms."
11284543|NCT02863263|BG002|Baseline|Total|Total of all reporting groups
11284544|NCT02863263|FG000|Participant Flow|Foam Dressing|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms."
11284545|NCT02863263|FG001|Participant Flow|Foam Dressing With Povidone Iodine|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms."
11284546|NCT02863263|OG000|Outcome|Foam Dressing|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms."
11284547|NCT02863263|OG001|Outcome|Foam Dressing With Povidone Iodine|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms."
11284548|NCT02863263|EG000|Reported Event|Foam Dressing|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms."
11287170|NCT02898974|BG000|Baseline|Regular Medical Marijuana Users|"People with MS that are regular Medical Marijuana users~Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design"
11287171|NCT02898974|BG001|Baseline|Non Users of Medical Marijuana|People with MS that are non users of Medical Marijuana
11284549|NCT02863263|EG001|Reported Event|Foam Dressing With Povidone Iodine|"Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily.~Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms."
11284550|NCT02863289|BG000|Baseline|Children With Proximal Humerus Fractures|Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
11284551|NCT02863289|FG000|Participant Flow|Children With Proximal Humerus Fractures|Children aged from 10 to 18-year-old in NHS Tayside who sustained proximal humerus fractures during year 2008 to 2015.
11284552|NCT02863289|OG000|Outcome|Children With Proximal Humerus Fractures|Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
11284553|NCT02863289|OG000|Outcome|Radiological Outcomes|The radiological parameters of all 118 study participants
11284554|NCT02863289|EG000|Reported Event|Children With Proximal Humerus Fractures|Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
11284555|NCT02863328|BG000|Baseline|Oral Semaglutide 14 mg|Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
11284556|NCT02863328|BG001|Baseline|Empagliflozin 25 mg|Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
11284557|NCT02863328|BG002|Baseline|Total|Total of all reporting groups
11284558|NCT02863328|FG000|Participant Flow|Oral Semaglutide 14 mg|Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
11284559|NCT02863328|FG001|Participant Flow|Empagliflozin 25 mg|Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
11284560|NCT02863328|OG000|Outcome|Oral Semaglutide 14 mg|Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
11284561|NCT02863328|OG001|Outcome|Empagliflozin 25 mg|Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
11284562|NCT02863328|EG000|Reported Event|Oral Semaglutide 14 mg|Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
11284563|NCT02863328|EG001|Reported Event|Empagliflozin 25 mg|Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
11284564|NCT02863354|BG000|Baseline|Q4WKS|"Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.~If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.~Aflibercept: Intravitreal injection"
11284565|NCT02863354|BG001|Baseline|Q12WKS|"Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.~At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.~Aflibercept: Intravitreal injection"
11284566|NCT02863354|BG002|Baseline|Total|Total of all reporting groups
11284567|NCT02863354|FG000|Participant Flow|Q4WKS|"Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.~If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.~Aflibercept: Intravitreal injection"
11284568|NCT02863354|FG001|Participant Flow|Q12WKS|"Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.~At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.~Aflibercept: Intravitreal injection"
11287172|NCT02898974|BG002|Baseline|Total|Total of all reporting groups
11284569|NCT02863354|OG000|Outcome|Q4WKS|"Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.~If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.~Aflibercept: Intravitreal injection"
11284570|NCT02863354|OG001|Outcome|Q12WKS|"Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.~At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.~Aflibercept: Intravitreal injection"
11284571|NCT02863354|EG000|Reported Event|Q4WKS|"Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.~If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.~Aflibercept: Intravitreal injection"
11284572|NCT02863354|EG001|Reported Event|Q12WKS|"Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.~At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.~Aflibercept: Intravitreal injection"
11284573|NCT02863419|BG000|Baseline|Oral Semaglutide 14 mg|Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284574|NCT02863419|BG001|Baseline|Liraglutide 1.8 mg|Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284575|NCT02863419|BG002|Baseline|Placebo|Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284576|NCT02863419|BG003|Baseline|Total|Total of all reporting groups
11284577|NCT02863419|FG000|Participant Flow|Oral Semaglutide 14 mg|Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284578|NCT02863419|FG001|Participant Flow|Liraglutide 1.8 mg|Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284579|NCT02863419|FG002|Participant Flow|Placebo|Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284580|NCT02863419|OG000|Outcome|Oral Semaglutide 14 mg|Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11287173|NCT02898974|FG000|Participant Flow|Regular Medical Marijuana Users|"People with MS that are regular Medical Marijuana users~Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design"
11284581|NCT02863419|OG001|Outcome|Liraglutide 1.8 mg|Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284582|NCT02863419|OG002|Outcome|Placebo|Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284583|NCT02863419|EG000|Reported Event|Oral Semaglutide 14 mg|Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52). In addition, participants were to take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284584|NCT02863419|EG001|Reported Event|Liraglutide 1.8 mg|Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284585|NCT02863419|EG002|Reported Event|Placebo|Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 [SGLT-2] inhibitor) throughout the entire trial.
11284586|NCT02863575|BG000|Baseline|Ibuprofen 400 mg + Caffeine 100 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284587|NCT02863575|BG001|Baseline|Ibuprofen 400 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284588|NCT02863575|BG002|Baseline|Placebo|Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284589|NCT02863575|BG003|Baseline|Total|Total of all reporting groups
11284590|NCT02863575|FG000|Participant Flow|Ibuprofen 400 mg + Caffeine 100 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 milligram (mg) with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284591|NCT02863575|FG001|Participant Flow|Ibuprofen 400 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284592|NCT02863575|FG002|Participant Flow|Placebo|Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284593|NCT02863575|OG000|Outcome|Ibuprofen 400 mg + Caffeine 100 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284594|NCT02863575|OG001|Outcome|Ibuprofen 400 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284595|NCT02863575|OG002|Outcome|Placebo|Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284596|NCT02863575|EG000|Reported Event|Ibuprofen 400 mg + Caffeine 100 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284597|NCT02863575|EG001|Reported Event|Ibuprofen 400 mg|Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284598|NCT02863575|EG002|Reported Event|Placebo|Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
11284599|NCT02864069|BG000|Baseline|Walking Intervention|Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
11287174|NCT02898974|FG001|Participant Flow|Non Users of Medical Marijuana|People with MS that are non users of Medical Marijuana
11284600|NCT02864069|BG001|Baseline|Cognitive Training Intervention|Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
11284601|NCT02864069|BG002|Baseline|Combined Intervention|Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
11284602|NCT02864069|BG003|Baseline|Total|Total of all reporting groups
11284603|NCT02864069|FG000|Participant Flow|Walking Intervention|Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
11284604|NCT02864069|FG001|Participant Flow|Cognitive Training Intervention|Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
11284605|NCT02864069|FG002|Participant Flow|Combined Intervention|Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
11284606|NCT02864069|OG000|Outcome|Walking Intervention|Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
11284607|NCT02864069|OG001|Outcome|Cognitive Training Intervention|Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
11284608|NCT02864069|OG002|Outcome|Combined Intervention|Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
11284609|NCT02864069|EG000|Reported Event|Walking Intervention|Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
11284610|NCT02864069|EG001|Reported Event|Cognitive Training Intervention|Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
11284611|NCT02864069|EG002|Reported Event|Combined Intervention|Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
11284612|NCT02864082|BG000|Baseline|Group 1 PAT-001 0.1% and Vehicle|"Part 1 (weeks 0-8): Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.1% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284613|NCT02864082|BG001|Baseline|Group 2 PAT-001 0.2% and Vehicle|"Part 1 (weeks 0-8): Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.2% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: (weeks 8-12) Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284614|NCT02864082|BG002|Baseline|Total|Total of all reporting groups
11287175|NCT02898974|OG000|Outcome|Regular Medical Marijuana Users|"People with MS that are regular Medical Marijuana users~Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design"
11287176|NCT02898974|OG001|Outcome|Non Users of Medical Marijuana|People with MS that are non users of Medical Marijuana
11284615|NCT02864082|FG000|Participant Flow|Group 1 PAT-001 0.1% and Vehicle|"Part 1 (8 weeks): Patients will have two comparable Treatment Areas on their bodies, for example both upper arms that have same degree of disease. PAT-001, 0.1% will be applied to one of those body parts for 8 weeks, applied twice a day. The matching body part will have vehicle applied twice a day for 8 weeks~Part 2 (4 weeks): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.1% so that subjects cannot tell the difference between vehicle and PAT-001 based upon appearance."
11284616|NCT02864082|FG001|Participant Flow|Group 2 PAT-001 0.2% and Vehicle|"Part 1 (8 weeks): Patients will have two comparable Treatment Areas on their bodies, for example both upper arms that have same degree of disease. PAT-001, 0.2% will be applied to one of those body parts for 8 weeks, applied twice a day. The matching body part will have vehicle applied twice a day for 8 weeks.~Part 2 (4 weeks): Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.1% so that subjects cannot tell the difference between vehicle and PAT-001 based upon appearance."
11284617|NCT02864082|OG000|Outcome|Group 1 PAT-001 0.1%|"Part 1 (Weeks 0-8): Patients will have two comparable Treatment Areas of equal size and degree of severity: PAT-001, 0.1% will be applied to one of the 2 areas twice a day for 8 weeks~Part 2 (Weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug."
11284618|NCT02864082|OG001|Outcome|Group 2 PAT-001 0.2%|"Part 1 (Weeks 0-8): Patients will have two comparable Treatment Areas of equal size and degree of severity: PAT-001, 0.2% will be applied to one of the 2 areas twice a day for 8 weeks~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug."
11284619|NCT02864082|OG002|Outcome|Group 1 Vehicle|"Part 1 (Weeks 0-8): Patients will have two comparable Treatment Areas of equal size and degree of severity: Vehicle will be applied to one of the 2 areas twice a day for 8 weeks~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284620|NCT02864082|OG003|Outcome|Group 2 Vehicle|"Part 1 (Weeks 0-8): Patients will have two comparable Treatment Areas of equal size and degree of severity: Vehicle will be applied to one of the 2 areas twice a day for 8 weeks~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284621|NCT02864082|OG000|Outcome|Group 1 PAT-001 0.1%|"Part 1 (weeks 0-8): Bilateral randomized comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.1% is applied to one side Part 2 (weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug."
11284622|NCT02864082|OG001|Outcome|Group 1 Vehicle|"Part 1 (weeks 0-8): Bilateral randomized comparison. Patients will have two comparable Treatment Areas: Vehicle, 0.0% will be applied to one of the sides Part 2 (weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284623|NCT02864082|OG002|Outcome|Group 2 PAT-001 0.2%|"Part 1 (weeks 0-8): Bilateral randomized comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.2% will be applied to one side Part 2 (weeks 8-12): Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug."
11284624|NCT02864082|OG003|Outcome|Group 2 Vehicle|"Part 1 (weeks 0-8): Bilateral randomized comparison. Patients will have two comparable Treatment Areas: PAT-001 Vehicle, 0.0% will be applied to one side Part 2 (weeks 8-12): Patients will apply PAT-001, 0.2% to both Treatment Areas.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug."
11284625|NCT02864082|OG000|Outcome|Group 1 PAT-001 0.1%|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.1% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284626|NCT02864082|OG001|Outcome|Group 2 PAT-001 0.2%|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.2% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284627|NCT02864082|OG002|Outcome|Group 1 Vehicle|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.1% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284628|NCT02864082|OG003|Outcome|Group 2 Vehicle|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.2% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284629|NCT02864082|OG000|Outcome|Group 1|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.1% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11092440|NCT01539980|OG000|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
11215191|NCT02297503|FG001|Participant Flow|Filler Alone as Initial Treatment|HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11215192|NCT02297503|OG000|Outcome|Azzalure Alone as Initial Treatment|Subjects receiving Azzalure as initial treatment
11215193|NCT02297503|OG001|Outcome|Filler Alone as Initial Treatment|Subjects receiving HA filler as initial treatment.
11215194|NCT02297503|OG000|Outcome|Azzalure Alone as Initial Treatment|Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11215195|NCT02297503|OG001|Outcome|Filler Alone as Initial Treatment|Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
11215196|NCT02297503|OG000|Outcome|All Subjects|
11215197|NCT02297503|OG000|Outcome|Filler Alone as Initial Treatment|The participants randomized to receive filler alone as initial single treatment.
11215198|NCT02297503|OG001|Outcome|All Subjects|All subjects received filler at the combined treatments.
11215199|NCT02297503|EG000|Reported Event|Group A (Azzalure): After Single Treatment|Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
11215200|NCT02297503|EG001|Reported Event|Group B (Filler): After Single Treatment|Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.
11215201|NCT02297503|EG002|Reported Event|Group A: After 1st Combined Treatment|Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
11215202|NCT02297503|EG003|Reported Event|Group B: After 1st Combined Treatment|Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.
11215203|NCT02297503|EG004|Reported Event|Group A: After 2nd Combined Treatment|Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 2nd combined treatment was given.
11215204|NCT02297503|EG005|Reported Event|Group B: After 2nd Combined Treatment|Group B received filler alone as initial single treatment, and thereafter two combined treatments.Events reported in this section occurred after the 2nd combined treatment was given.
11215205|NCT02297516|BG000|Baseline|Azzalure/Dysport as Single Treatment|"Azzalure/Dysport as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215206|NCT02297516|BG001|Baseline|Filler as Single Treatment|"Filler as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215207|NCT02297516|BG002|Baseline|Total|Total of all reporting groups
11215208|NCT02297516|FG000|Participant Flow|Azzalure/Dysport as Single Treatment|"Azzalure/Dysport as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215209|NCT02297516|FG001|Participant Flow|Filler as Single Treatment|"Filler as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215210|NCT02297516|OG000|Outcome|Azzalure/Dysport as Single Treatment|"Azzalure/Dysport as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215211|NCT02297516|OG001|Outcome|Filler as Single Treatment|"Filler as single treatment at initial treatment~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215212|NCT02297516|OG000|Outcome|All Subjects|Both treatment groups combined
11215213|NCT02297516|OG000|Outcome|Azzalure/Dysport as Single Treatment|"Azzalure/Dysport as single treatment at initial treatment~Combination treatment at Month 6 and Month 12:~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215214|NCT02297516|OG001|Outcome|Filler as Single Treatment|"Filler as single treatment at initial treatment~Combination treatment at Month 6 and Month 12:~Azzalure or Dysport: Upper facial lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215215|NCT02297516|OG000|Outcome|Azzalure/Dysport as Single Treatment|"Azzalure/Dysport as single treatment at initial treatment~Azzalure or Dysport: Glabellar lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215216|NCT02297516|OG001|Outcome|Filler as Single Treatment|"Filler as single treatment at initial treatment~Azzalure or Dysport: Glabellar lines~Restylane or Emervel filler: Facial tissue augmentation~Restylane Skinbooster: Facial skin rejuvenation"
11215217|NCT02297516|EG000|Reported Event|After Single Treatment - Azzalure/Dysport|Subjects receiving Azzalure/Dysport as the initial single treatment.
11215218|NCT02297516|EG001|Reported Event|After Single Treatment - Filler|Subjects receiving Filler as the initial single treatment.
11215219|NCT02297516|EG002|Reported Event|After 1st Combination Treatment - All Subjects|Both treatment groups combined, since they received the same treatment during the combination treatment phase.
11215220|NCT02297516|EG003|Reported Event|After 2nd Combination Treatment - All Subjects|Both treatment groups combined, since they received the same treatment during the combination treatment phase.
11284630|NCT02864082|OG001|Outcome|Group 2 (Part 1)|"Part 1: Bilateral comparison. Patients will have two comparable Treatment Areas: PAT-001, 0.2% (e.g., left side) and Vehicle, 0.0% (e.g., right side).~Part 2: Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001."
11284631|NCT02864082|EG000|Reported Event|Group 1 PAT-001 0.1%|"Part 1 (weeks 0-8) Patients will have two comparable identical Treatment Areas: PAT-001, 0.1% will be applied to one of these areas.~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug."
11284632|NCT02864082|EG001|Reported Event|Group 2 PAT-001 0.2%|"Part 1 (weeks 0-8) Patients will have two comparable identical Treatment Areas: PAT-001, 0.2% will be applied to one of these areas.~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.2% to both Treatment Areas.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug."
11284633|NCT02864082|EG002|Reported Event|Group 1 Vehicle|"Part 1 (weeks 0-8) Patients will have two comparable identical Treatment Areas: Vehicle, 0.0% will be applied to one of these areas.~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.1% to both Treatment Areas.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001.~PAT-001, 0.1%: PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug."
11284634|NCT02864082|EG003|Reported Event|Group 2 Vehicle|"Part 1 (weeks 0-8) Patients will have two comparable identical Treatment Areas: Vehicle 0.0% will be applied to one of these areas.~Part 2 (weeks 8-12): Patients will apply PAT-001, 0.2% to both Treatment Areas.~Vehicle: Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001.~PAT-001, 0.2%: PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug."
11284635|NCT02864316|BG000|Baseline|Radiation-Induced Metastatic Sarcoma|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284636|NCT02864316|BG001|Baseline|Radiation-Induced Non-Sarcoma Metastatic Solid Tumors|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284637|NCT02864316|BG002|Baseline|Total|Total of all reporting groups
11284638|NCT02864316|FG000|Participant Flow|Radiation-Induced Metastatic Sarcoma|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284639|NCT02864316|FG001|Participant Flow|Radiation-Induced Non-Sarcoma Metastatic Solid Tumors|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284640|NCT02864316|OG000|Outcome|Radiation-Induced Metastatic Sarcoma|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284641|NCT02864316|OG001|Outcome|Radiation-Induced Non-Sarcoma Metastatic Solid Tumors|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284642|NCT02864316|EG000|Reported Event|Radiation-Induced Metastatic Sarcoma|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284643|NCT02864316|EG001|Reported Event|Radiation-Induced Non-Sarcoma Metastatic Solid Tumors|"a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.~Nivolumab"
11284644|NCT02864342|BG000|Baseline|Control Group|"All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance."
11284645|NCT02864342|BG001|Baseline|Intervention Group|"All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application."
11284646|NCT02864342|BG002|Baseline|Total|Total of all reporting groups
11284647|NCT02864342|FG000|Participant Flow|Control Group|"All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance."
11284648|NCT02864342|FG001|Participant Flow|Intervention Group|"All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application."
11284649|NCT02864342|OG000|Outcome|Control Group|"All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance."
11284650|NCT02864342|OG001|Outcome|Intervention Group|"All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application."
11284651|NCT02864342|OG000|Outcome|Intervention Group|"All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application."
11284652|NCT02864342|EG000|Reported Event|CONTROL GROUP|"All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.~Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance."
11284653|NCT02864342|EG001|Reported Event|INTERVENTION GROUP|All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
11284654|NCT02864355|BG000|Baseline|Goal Directed Therapy|"In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.~Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures."
11284655|NCT02864355|BG001|Baseline|Usual Care|Standard of care will be used to manage blood pressures.
11284656|NCT02864355|BG002|Baseline|Total|Total of all reporting groups
11284657|NCT02864355|FG000|Participant Flow|Goal Directed Therapy|"In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.~Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures."
11284658|NCT02864355|FG001|Participant Flow|Usual Care|Standard of care will be used to manage blood pressures.
11284659|NCT02864355|OG000|Outcome|Goal Directed Therapy|"In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.~Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures."
11284660|NCT02864355|OG001|Outcome|Usual Care|Standard of care will be used to manage blood pressures.
11284661|NCT02864355|EG000|Reported Event|Goal Directed Therapy|"In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.~Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures."
11284662|NCT02864355|EG001|Reported Event|Usual Care|Standard of care will be used to manage blood pressures.
11284663|NCT02864381|BG000|Baseline|Andecaliximab + Nivolumab|Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
11284664|NCT02864381|BG001|Baseline|Nivolumab|Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
11284665|NCT02864381|BG002|Baseline|Total|Total of all reporting groups
11284666|NCT02864381|FG000|Participant Flow|Andecaliximab + Nivolumab|Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
11284667|NCT02864381|FG001|Participant Flow|Nivolumab|Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
11284668|NCT02864381|OG000|Outcome|Andecaliximab + Nivolumab|Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
11284669|NCT02864381|OG001|Outcome|Nivolumab|Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
11284670|NCT02864381|EG000|Reported Event|Andecaliximab + Nivolumab|Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
11284671|NCT02864381|EG001|Reported Event|Nivolumab|Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
11284672|NCT02864394|BG000|Baseline|Pembrolizumab|Participants with NSCLC receive pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
11284673|NCT02864394|BG001|Baseline|Docetaxel|Participants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue, or consent withdrawal.
11284674|NCT02864394|BG002|Baseline|Total|Total of all reporting groups
11284675|NCT02864394|FG000|Participant Flow|Pembrolizumab|Participants with NSCLC receive pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
11284676|NCT02864394|FG001|Participant Flow|Docetaxel|Participants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue, or consent withdrawal.
11284677|NCT02864394|OG000|Outcome|Pembrolizumab|Participants with NSCLC receive pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
11284678|NCT02864394|OG001|Outcome|Docetaxel|Participants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue, or consent withdrawal.
11284679|NCT02864394|EG000|Reported Event|Pembrolizumab|Participants with NSCLC receive pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes Q3W for up to 35 doses (approximately 24 months).
11284680|NCT02864394|EG001|Reported Event|Docetaxel|Participants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue, or consent withdrawal.
11092441|NCT01539980|EG000|Reported Event|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
11284681|NCT02864706|BG000|Baseline|Everolimus|patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks
11284682|NCT02864706|BG001|Baseline|Control|patients received standard CsA, MMF and corticosteroids
11284683|NCT02864706|BG002|Baseline|Total|Total of all reporting groups
11284684|NCT02864706|FG000|Participant Flow|Everolimus|patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks
11284685|NCT02864706|FG001|Participant Flow|Control|patients received standard CsA, MMF and corticosteroids
11284686|NCT02864706|OG000|Outcome|Everolimus|patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks
11284687|NCT02864706|OG001|Outcome|Control|patients received standard CsA, MMF and corticosteroids
11284688|NCT02864706|EG000|Reported Event|Everolimus|All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
11284689|NCT02864706|EG001|Reported Event|Control|patients received standard CsA, MMF and corticosteroids
11284690|NCT02864732|BG000|Baseline|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
11284691|NCT02864732|BG001|Baseline|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
11284692|NCT02864732|BG002|Baseline|Total|Total of all reporting groups
11284693|NCT02864732|FG000|Participant Flow|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
11284694|NCT02864732|FG001|Participant Flow|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
11284695|NCT02864732|OG000|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
11284696|NCT02864732|OG000|Outcome|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
11287177|NCT02898974|EG000|Reported Event|Regular Medical Marijuana Users|"People with MS that are regular Medical Marijuana users~Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design"
11284697|NCT02864732|OG001|Outcome|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
11284698|NCT02864732|EG000|Reported Event|Stabilization Exercises|"The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.~Rehabilitation exercises"
11284699|NCT02864732|EG001|Reported Event|Stabilization Exercises Plus Electrical Stimulation|"The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.~Rehabilitation exercises~Electrical Stimulation"
11284700|NCT02865343|BG000|Baseline|Non-invasive Ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284701|NCT02865343|BG001|Baseline|Sham Non-invasive Ventilation(NIV)|Sham Non-invasive ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284702|NCT02865343|BG002|Baseline|Total|Total of all reporting groups
11284703|NCT02865343|FG000|Participant Flow|Non-invasive Ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284704|NCT02865343|FG001|Participant Flow|Sham Non-invasive Ventilation(NIV)|Sham Non-invasive ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284705|NCT02865343|OG000|Outcome|Non-invasive Ventilation(NIV)|"Subjects randomized to NIV will perform 12-weeks of FES-row training while receiving bi-level positive airway pressure ventilation applied through a full face-mask.~Non-invasive Ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration."
11284706|NCT02865343|OG001|Outcome|Sham Non-invasive Ventilation(NIV)|"Subjects randomized to Sham-NIV will perform 12-weeks of FES-row training while receiving sham ventilation applied through a full face-mask.~Sham Non-invasive ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration."
11284707|NCT02865343|OG000|Outcome|Non-invasive Ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284708|NCT02865343|OG001|Outcome|Sham Non-invasive Ventilation(NIV)|Sham Non-invasive ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284709|NCT02865343|EG000|Reported Event|Non-invasive Ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284710|NCT02865343|EG001|Reported Event|Sham Non-invasive Ventilation(NIV)|Sham Non-invasive ventilation(NIV): The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
11284711|NCT02865434|BG000|Baseline|Group 1 (RA)|"Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284712|NCT02865434|BG001|Baseline|Group 2 (RA)|"Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11287178|NCT02898974|EG001|Reported Event|Non Users of Medical Marijuana|People with MS that are non users of Medical Marijuana
11287179|NCT02899156|BG000|Baseline|Flumazenil Infusion|"The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Flumazenil"
11287180|NCT02899156|BG001|Baseline|Placebo Infusion|"The placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Placebo: 0.9% normal saline"
11287181|NCT02899156|BG002|Baseline|Total|Total of all reporting groups
11284713|NCT02865434|BG002|Baseline|Group 3 (RA)|"Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284714|NCT02865434|BG003|Baseline|Group 4 (RA)|"Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284715|NCT02865434|BG004|Baseline|Group 5 (RA)|"Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284716|NCT02865434|BG005|Baseline|Group 6 (RA)|"Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284717|NCT02865434|BG006|Baseline|Group 7 (RA)|"Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284718|NCT02865434|BG007|Baseline|Group 8 (RA)|"Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284719|NCT02865434|BG008|Baseline|Group 9 (RA)|"Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11287182|NCT02899156|FG000|Participant Flow|Flumazenil Group|"The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Flumazenil"
11287183|NCT02899156|FG001|Participant Flow|Placebo Group|"The placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Placebo: 0.9% normal saline"
11284720|NCT02865434|BG009|Baseline|Group 10 (Healthy Controls)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284721|NCT02865434|BG010|Baseline|Group 11 (RA)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284722|NCT02865434|BG011|Baseline|Total|Total of all reporting groups
11284723|NCT02865434|FG000|Participant Flow|Group 1 (RA)|"Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284724|NCT02865434|FG001|Participant Flow|Group 2 (RA)|"Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284725|NCT02865434|FG002|Participant Flow|Group 3 (RA)|"Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284726|NCT02865434|FG003|Participant Flow|Group 4 (RA)|"Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284727|NCT02865434|FG004|Participant Flow|Group 5 (RA)|"Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11287184|NCT02899156|OG000|Outcome|Flumazenil Group|"The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Flumazenil"
11284728|NCT02865434|FG005|Participant Flow|Group 6 (RA)|"Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284729|NCT02865434|FG006|Participant Flow|Group 7 (RA)|"Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284730|NCT02865434|FG007|Participant Flow|Group 8 (RA)|"Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284731|NCT02865434|FG008|Participant Flow|Group 9 (RA)|"Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284732|NCT02865434|FG009|Participant Flow|Group 10 (Healthy Controls)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284733|NCT02865434|FG010|Participant Flow|Group 11 (RA)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11092442|NCT01540045|BG000|Baseline|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
11092443|NCT01540045|FG000|Participant Flow|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
11092444|NCT01540045|OG000|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
11092445|NCT01540045|OG001|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
11092446|NCT01540045|OG000|Outcome|Pre-chemotherapy Patientes|body composition pre-chemotherapy
11092447|NCT01540045|OG001|Outcome|Post-chemotherapy Patients|body composition post chemotherapy
11092448|NCT01540045|OG000|Outcome|Pre-chemotherapy Patientes|body mass index pre-chemotherapty
11092449|NCT01540045|OG001|Outcome|Post-chemotherapy Patients|body mass index post chemotherapy
11092450|NCT01540045|OG000|Outcome|Pre-chemotherapy Patientes|Subjective Global Assessment pre-chemotherapy
11092451|NCT01540045|OG001|Outcome|Post-chemotherapy Patientes|Subjective Global Assessment post chemotherapy
11284734|NCT02865434|OG000|Outcome|Group 1 (RA)|"Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284735|NCT02865434|OG001|Outcome|Group 2 (RA)|"Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284736|NCT02865434|OG002|Outcome|Group 3 (RA)|"Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284737|NCT02865434|OG003|Outcome|Group 4 (RA)|"Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284738|NCT02865434|OG004|Outcome|Group 5 (RA)|"Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284739|NCT02865434|OG005|Outcome|Group 6 (RA)|"Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284740|NCT02865434|OG006|Outcome|Group 7 (RA)|"Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11287185|NCT02899156|OG001|Outcome|Placebo Group|"The placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Placebo: 0.9% normal saline"
11287186|NCT02899156|EG000|Reported Event|Flumazenil Group|"The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Flumazenil"
11284741|NCT02865434|OG007|Outcome|Group 8 (RA)|"Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284742|NCT02865434|OG008|Outcome|Group 9 (RA)|"Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284743|NCT02865434|OG009|Outcome|Group 10 (Healthy Controls)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284744|NCT02865434|OG010|Outcome|Group 11 (RA)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284745|NCT02865434|OG009|Outcome|Group 10 (Healthy Controls)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc99m at the MTD via IV injection.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection)~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284746|NCT02865434|OG010|Outcome|Group 11 (RA)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc99m-tilmanocept at the MTD via IV injection.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection)~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284747|NCT02865434|OG009|Outcome|Group 10 (HC Females)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11092452|NCT01540045|OG000|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|patient with more sensibility to perceive sweet taste from food
11092453|NCT01540045|OG001|Outcome|< Sweet Perception Thresholds After Chemotherapy|patient with less sensibility to perceive sweet taste from food
11092454|NCT01540045|OG000|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
11092455|NCT01540045|OG001|Outcome|< Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
11092456|NCT01540045|OG000|Outcome|HRQL Pre-chemotherapy|Score of scale HRQL EORTC
11284748|NCT02865434|OG010|Outcome|Group 10 (HC Males)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284749|NCT02865434|OG011|Outcome|Group 11 (RA Females)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284750|NCT02865434|OG012|Outcome|Group 11 (RA Males)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284751|NCT02865434|EG000|Reported Event|Group 1 (RA)|"Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284752|NCT02865434|EG001|Reported Event|Group 2 (RA)|"Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284753|NCT02865434|EG002|Reported Event|Group 3 (RA)|"Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284754|NCT02865434|EG003|Reported Event|Group 4 (RA)|"Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11287187|NCT02899156|EG001|Reported Event|Placebo Group|"The placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.~Placebo: 0.9% normal saline"
11284755|NCT02865434|EG004|Reported Event|Group 5 (RA)|"Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284756|NCT02865434|EG005|Reported Event|Group 6 (RA)|"Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284757|NCT02865434|EG006|Reported Event|Group 7 (RA)|"Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284758|NCT02865434|EG007|Reported Event|Group 8 (RA)|"Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284759|NCT02865434|EG008|Reported Event|Group 9 (RA)|"Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection).~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.~SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.~Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection."
11284760|NCT02865434|EG009|Reported Event|Group 10 (Healthy Controls)|"Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284761|NCT02865434|EG010|Reported Event|Group 11 (RA)|"Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m the MTD via IV injection.~Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.~Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection).~Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection).~Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection)."
11284762|NCT02865499|BG000|Baseline|Acarbose|"all participants to receive acarbose~acarbose: acarbose treatment with meals"
11284763|NCT02865499|FG000|Participant Flow|Acarbose|"all participants will receive acarbose~acarbose: acarbose treatment with meals"
11284764|NCT02865499|OG000|Outcome|Acarbose|Stool specimens from all participants analyzed after acarbose
11284765|NCT02865499|EG000|Reported Event|Acarbose|"all participants will receive acarbose~acarbose: acarbose treatment with meals"
11284766|NCT02865538|BG000|Baseline|Placebo Comparator|Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
11284767|NCT02865538|BG001|Baseline|50 mg BAY3427080|50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284768|NCT02865538|BG002|Baseline|100 mg BAY3427080|100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
11284769|NCT02865538|BG003|Baseline|150 mg BAY3427080|150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284770|NCT02865538|BG004|Baseline|300 mg of BAY3427080|300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284771|NCT02865538|BG005|Baseline|Total|Total of all reporting groups
11284772|NCT02865538|FG000|Participant Flow|Placebo Comparator|Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
11284773|NCT02865538|FG001|Participant Flow|50 mg BAY3427080|50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284774|NCT02865538|FG002|Participant Flow|100 mg BAY3427080|100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
11284775|NCT02865538|FG003|Participant Flow|150 mg BAY3427080|150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284776|NCT02865538|FG004|Participant Flow|300 mg of BAY3427080|300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284777|NCT02865538|OG000|Outcome|Placebo|Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
11284778|NCT02865538|OG001|Outcome|50 mg BAY3427080|50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11092457|NCT01540045|OG001|Outcome|HRQL Post-chemotherapy|Score of scale HRQL EORTC
11092458|NCT01540045|OG000|Outcome|> or = Umami Perception Thresholds|"patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
11092459|NCT01540045|OG001|Outcome|< Umami Perception Thresholds|"patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
11284779|NCT02865538|OG002|Outcome|100 mg BAY3427080|100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284780|NCT02865538|OG003|Outcome|150 mg BAY3427080|150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
11284781|NCT02865538|OG004|Outcome|300 mg BAY3427080|300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284782|NCT02865538|EG000|Reported Event|Placebo Comparator|Placebo to match BAY3427080 (NT-814) capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
11284783|NCT02865538|EG001|Reported Event|50 mg BAY3427080|50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284784|NCT02865538|EG002|Reported Event|100 mg BAY3427080|100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284785|NCT02865538|EG003|Reported Event|150 mg BAY3427080|150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
11284786|NCT02865538|EG004|Reported Event|300 mg BAY3427080|300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
11284787|NCT02865590|BG000|Baseline|Lyophilized Equine Bone Allograft|"Sinus Lift with Lyophilized Equine Bone Allograft~sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)"
11284788|NCT02865590|BG001|Baseline|Deproteinized Bovine Bone Allograft|"Sinus lift with deproteinized bovine bone allograft~Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)"
11284789|NCT02865590|BG002|Baseline|Total|Total of all reporting groups
11284790|NCT02865590|FG000|Participant Flow|Lyophilized Equine Bone Allograft|"Sinus Lift with Lyophilized Equine Bone Allograft~sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)"
11284791|NCT02865590|FG001|Participant Flow|Deproteinized Bovine Bone Allograft|"Sinus lift with deproteinized bovine bone allograft~Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)"
11284792|NCT02865590|OG000|Outcome|Lyophilized Equine Bone Allograft|"Sinus Lift with Lyophilized Equine Bone Allograft~sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)"
11284793|NCT02865590|OG001|Outcome|Deproteinized Bovine Bone Allograft|"Sinus lift with deproteinized bovine bone allograft~Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)"
11284794|NCT02865590|EG000|Reported Event|Lyophilized Equine Bone Allograft|"Sinus Lift with Lyophilized Equine Bone Allograft~sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)"
11284795|NCT02865590|EG001|Reported Event|Deproteinized Bovine Bone Allograft|"Sinus lift with deproteinized bovine bone allograft~Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)"
11284796|NCT02865720|BG000|Baseline|CINRYZE 500 U|Participants received 500 U CINRYZE IV injection twice weekly for 12 weeks.
11284797|NCT02865720|BG001|Baseline|CINRYZE 1000 U|Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks.
11284798|NCT02865720|BG002|Baseline|Total|Total of all reporting groups
11284799|NCT02865720|FG000|Participant Flow|CINRYZE 500 U|Participants received 500 U CINRYZE intravenous (IV) injection twice weekly for 12 weeks.
11284800|NCT02865720|FG001|Participant Flow|CINRYZE 1000 U|Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks.
11284801|NCT02865720|OG000|Outcome|CINRYZE 1000 U|Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks.
11284802|NCT02865720|OG000|Outcome|CINRYZE 1000U|Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks.
11284803|NCT02865720|EG000|Reported Event|CINRYZE 1000 U|Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks.
11284804|NCT02865811|BG000|Baseline|Pembrolizumab in Combination With PLD|"A safety lead in with 6 patients will be studied prior the start of the treatment.~If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.~If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)~Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV~Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag"
11284805|NCT02865811|FG000|Participant Flow|Pembrolizumab in Combination With PLD|"A safety lead in with 6 patients will be studied prior the start of the treatment.~If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.~If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)~Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV~Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag"
11284806|NCT02865811|OG000|Outcome|Pembrolizumab in Combination With PLD|"A safety lead in with 6 patients will be studied prior the start of the treatment.~If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.~If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)~Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV~Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage~Pembrolizumab: Please see Arms for description.~Pegylated Liposomal Doxorubicin (PLD): Please see Arms for description."
11284807|NCT02865811|OG000|Outcome|Pembrolizumab in Combination With PLD|"A safety lead in with 6 patients will be studied prior the start of the treatment.~If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.~If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)~Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV~Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag"
11284808|NCT02865811|EG000|Reported Event|Pembrolizumab in Combination With PLD|"A safety lead in with 6 patients will be studied prior the start of the treatment.~If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.~If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)~Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV~Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag"
11284809|NCT02866175|BG000|Baseline|Edoxaban Regimen|Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used).
11284810|NCT02866175|BG001|Baseline|Vitamin K Antagonist Regimen|Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
11284811|NCT02866175|BG002|Baseline|Total|Total of all reporting groups
11284812|NCT02866175|FG000|Participant Flow|Edoxaban Regimen|Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used).
11284813|NCT02866175|FG001|Participant Flow|Vitamin K Antagonist Regimen|Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
11284814|NCT02866175|OG000|Outcome|Edoxaban Regimen|Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used).
11284815|NCT02866175|OG001|Outcome|Vitamin K Antagonist Regimen|Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
11284816|NCT02866175|OG001|Outcome|Vitamin K Antagonist Regimen|Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
11284817|NCT02866175|EG000|Reported Event|Edoxaban Regimen|Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used).
11284818|NCT02866175|EG001|Reported Event|Vitamin K Antagonist Regimen|Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
11092460|NCT01540045|OG000|Outcome|> or = Umami Perception Thresholds|"peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
11092461|NCT01540045|OG001|Outcome|< Umami Perception Thresholds|"peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
11092462|NCT01540045|OG000|Outcome|< or = Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
11092463|NCT01540045|OG001|Outcome|> Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
11284819|NCT02866643|BG000|Baseline|Delivery Room Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).~Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery)."
11284820|NCT02866643|BG001|Baseline|Postpartum Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).~Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery."
11284821|NCT02866643|BG002|Baseline|Total|Total of all reporting groups
11284822|NCT02866643|FG000|Participant Flow|Delivery Room Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).~Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery)."
11284823|NCT02866643|FG001|Participant Flow|Postpartum Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).~Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery."
11284824|NCT02866643|OG000|Outcome|Delivery Room Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).~Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery)."
11284825|NCT02866643|OG001|Outcome|Postpartum Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).~Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery."
11284826|NCT02866643|EG000|Reported Event|Delivery Room Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).~Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery)."
11284827|NCT02866643|EG001|Reported Event|Postpartum Insertion|"Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).~Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery."
11284828|NCT02866942|BG000|Baseline|Asthma|"LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+~Administration of Live attenuated influenza vaccine (LAIV)"
11284829|NCT02866942|FG000|Participant Flow|Asthma|"LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+~Administration of Live attenuated influenza vaccine (LAIV)"
11284830|NCT02866942|OG000|Outcome|Asthma|"LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+~Administration of Live attenuated influenza vaccine (LAIV)"
11284831|NCT02866942|EG000|Reported Event|Asthma|"LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+~Administration of Live attenuated influenza vaccine (LAIV)"
11284832|NCT02867059|BG000|Baseline|First Dose|"The dose used in the first cohort was determined on the basis of the safety and PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and will be 150 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284833|NCT02867059|BG001|Baseline|Second Dose|"Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia) obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284834|NCT02867059|BG002|Baseline|Total|Total of all reporting groups
11284835|NCT02867059|FG000|Participant Flow|First Dose|"The dose used in the first cohort was determined on the basis of the safety and PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and will be 150 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284836|NCT02867059|FG001|Participant Flow|Second Dose|"Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia) obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284837|NCT02867059|OG000|Outcome|First Dose 150mg|"The dose used in the first cohort was determined on the basis of the safety and PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and will be 150 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284838|NCT02867059|OG001|Outcome|Second Dose 600mg|"Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia) obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284839|NCT02867059|EG000|Reported Event|First Dose|"The dose used in the first cohort was determined on the basis of the safety and PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and will be 150 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284840|NCT02867059|EG001|Reported Event|Second Dose|"Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia) obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600 mg.~(+)-SJ000557733: (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans."
11284841|NCT02867150|BG000|Baseline|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
11284842|NCT02867150|FG000|Participant Flow|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
11284843|NCT02867150|OG000|Outcome|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
11284844|NCT02867150|EG000|Reported Event|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional~Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
11284845|NCT02867163|BG000|Baseline|Knee Replacement Patients Receiving TXA|"Patients who receive tranexamic acid during total knee replacement surgery~Tranexamic Acid: Intravenous or local administration of TXA, in any dosage"
11284846|NCT02867163|FG000|Participant Flow|Knee Replacement Patients Receiving TXA|"Patients who receive tranexamic acid during total knee replacement surgery~Tranexamic Acid: Intravenous or local administration of TXA, in any dosage"
11284847|NCT02867163|OG000|Outcome|Knee Replacement Patients Receiving TXA|"Patients who receive tranexamic acid during total knee replacement surgery~Tranexamic Acid: Intravenous or local administration of TXA, in any dosage"
11284848|NCT02867163|EG000|Reported Event|Knee Replacement Patients Receiving TXA|"Patients who receive tranexamic acid during total knee replacement surgery~Tranexamic Acid: Intravenous or local administration of TXA, in any dosage"
11284849|NCT02867202|BG000|Baseline|Intrauterine Balloon|After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.
11284850|NCT02867202|BG001|Baseline|IUD Plus Foley Catheter|Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
11284851|NCT02867202|BG002|Baseline|Total|Total of all reporting groups
11284852|NCT02867202|FG000|Participant Flow|Intrauterine Balloon|After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.
11284853|NCT02867202|FG001|Participant Flow|Intrauterine Contraceptive Device Plus Foley Catheter|Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
11284854|NCT02867202|OG000|Outcome|Intrauterine Balloon|"The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.~Intrauterine balloon: After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week."
11284855|NCT02867202|OG001|Outcome|Intrauterine Device Plus Foley Catheter|"Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while Intrauterine Device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.~Intrauterine Contraceptive Device Plus Foley Catheter: After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy."
11284856|NCT02867202|EG000|Reported Event|Intrauterine Balloon|After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.
11284857|NCT02867202|EG001|Reported Event|IUD Plus Foley Catheter|Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
11284858|NCT02867605|BG000|Baseline|Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35|Hyaluronan
11284859|NCT02867605|FG000|Participant Flow|Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35|Hyaluronan
11284860|NCT02867605|OG000|Outcome|Day 0|Baseline/Pre Treatment
11284861|NCT02867605|OG001|Outcome|Day 8|Immediately post 7 day treatment
11284862|NCT02867605|OG002|Outcome|Day 28|28 days post treatment
11284863|NCT02867605|OG001|Outcome|Day 8|Immediately post 7 days of treatment
11284864|NCT02867605|OG000|Outcome|Day 0|Baseline/ Pretreatment
11284865|NCT02867605|OG001|Outcome|Day 8|immediately post treatment
11284866|NCT02867605|OG000|Outcome|Day 0|Baseline/pretreatment
11284867|NCT02867605|OG000|Outcome|Day 0|Baseline/Pretreatment
11284868|NCT02867605|OG000|Outcome|Day 0|Baseline/PreTreatment
11284869|NCT02867605|OG001|Outcome|Day 8|Immediately Post 7 days of treatment
11284870|NCT02867605|OG000|Outcome|Day 0|Baseline/Pre-treatment
11284871|NCT02867605|OG001|Outcome|Day 8|immediately post 7 days of treatment
11284872|NCT02867605|EG000|Reported Event|Day 0|Baseline/Pre Treatment
11284873|NCT02867605|EG001|Reported Event|Day 8|Immediately post 7 day treatment
11284874|NCT02867605|EG002|Reported Event|Day 28|28 days post treatment
11284875|NCT02867618|BG000|Baseline|Carfilzomib + TGR-1202|"Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.~Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202~TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib"
11284876|NCT02867618|FG000|Participant Flow|Carfilzomib + TGR-1202|"Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.~Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202~TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib"
11284877|NCT02867618|OG000|Outcome|Carfilzomib + TGR-1202|"Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.~Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202~TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib"
11284878|NCT02867618|EG000|Reported Event|Carfilzomib + TGR-1202|"Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.~Carfilzomib: Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202~TGR-1202: Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib"
11284879|NCT02867709|BG000|Baseline|Placebo|1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284880|NCT02867709|BG001|Baseline|Ubrogepant 25 mg|1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284881|NCT02867709|BG002|Baseline|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284882|NCT02867709|BG003|Baseline|Total|Total of all reporting groups
11284883|NCT02867709|FG000|Participant Flow|Placebo|1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284884|NCT02867709|FG001|Participant Flow|Ubrogepant 25 mg|1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284885|NCT02867709|FG002|Participant Flow|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284886|NCT02867709|OG000|Outcome|Placebo|1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284887|NCT02867709|OG001|Outcome|Ubrogepant 25 mg|1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284888|NCT02867709|OG002|Outcome|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284889|NCT02867709|EG000|Reported Event|Placebo|1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284890|NCT02867709|EG001|Reported Event|Ubrogepant 25 mg|1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284891|NCT02867709|EG002|Reported Event|Ubrogepant 50 mg|1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
11284892|NCT02867995|BG000|Baseline|No Drop Aid|No glaucoma drop aid received- control
11284893|NCT02867995|BG001|Baseline|Drop Aid|"Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)~Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator"
11284894|NCT02867995|BG002|Baseline|Total|Total of all reporting groups
11284895|NCT02867995|FG000|Participant Flow|Control|No glaucoma drop aid control
11284896|NCT02867995|FG001|Participant Flow|Eye Drop Aids|"Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)~Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator"
11284897|NCT02867995|OG000|Outcome|Control|No glaucoma drop aid control
11284898|NCT02867995|OG001|Outcome|Eye Drop Aids|"Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)~Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator"
11284899|NCT02867995|OG000|Outcome|AutoDrop|Patients placed in this group were given the Fabrication Autodrop Eye Drop Guide to instill their eye drops with
11284900|NCT02867995|OG001|Outcome|Autosqueeze|Participants placed in this group were given the Owen Mumford OP 6100 Autosqueeze in order to instill their eye drops.
11284901|NCT02867995|OG002|Outcome|Simply Touch|Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
11284902|NCT02867995|OG003|Outcome|Control|No glaucoma drop aid control
11284903|NCT02867995|EG000|Reported Event|Control|No glaucoma drop aid received- control
11284904|NCT02867995|EG001|Reported Event|Eye Drop Aids|"Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)~Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator"
11284905|NCT02868216|BG000|Baseline|Anger Management Training|"treatment group- Two monthly sessions will address the events triggering anger, the physiology of anger and the influence on the cardiovascular system, the dimesions of anger: cognitive, emotional and behavioral.~anger management training"
11284906|NCT02868216|BG001|Baseline|Without Management Training|No anger management training
11284907|NCT02868216|BG002|Baseline|Total|Total of all reporting groups
11284908|NCT02868216|FG000|Participant Flow|Anger Management Training|"treatment group- Two monthly sessions will address the events triggering anger, the physiology of anger and the influence on the cardiovascular system, the dimesions of anger: cognitive, emotional and behavioral.~anger management training"
11284909|NCT02868216|FG001|Participant Flow|Without Management Training|No anger management training
11284910|NCT02868216|OG000|Outcome|Anger Management Training|"treatment group- Two monthly sessions will address the events triggering anger, the physiology of anger and the influence on the cardiovascular system, the dimesions of anger: cognitive, emotional and behavioral.~anger management training"
11284911|NCT02868216|OG001|Outcome|Without Management Training|No anger management training
11284912|NCT02868216|EG000|Reported Event|Intervention|Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in intervention group
11284913|NCT02868216|EG001|Reported Event|Controls|Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in control group
11284914|NCT02868229|BG000|Baseline|Placebo|Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.
11284915|NCT02868229|BG001|Baseline|COR-001 2 mg|Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284916|NCT02868229|BG002|Baseline|COR-001 6 mg|Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284917|NCT02868229|BG003|Baseline|COR-001 20 mg|Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284918|NCT02868229|BG004|Baseline|Total|Total of all reporting groups
11284919|NCT02868229|FG000|Participant Flow|Placebo|Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.
11284920|NCT02868229|FG001|Participant Flow|COR-001 2 mg|Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284921|NCT02868229|FG002|Participant Flow|COR-001 6 mg|Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284922|NCT02868229|FG003|Participant Flow|COR-001 20 mg|Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284923|NCT02868229|OG000|Outcome|Placebo|Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.
11284924|NCT02868229|OG001|Outcome|COR-001 2 mg|Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284925|NCT02868229|OG002|Outcome|COR-001 6 mg|Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284926|NCT02868229|OG003|Outcome|COR-001 20 mg|Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284927|NCT02868229|OG000|Outcome|Placebo|Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284928|NCT02868229|OG000|Outcome|COR-001 2 mg|Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284929|NCT02868229|OG001|Outcome|COR-001 6 mg|Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284930|NCT02868229|OG002|Outcome|COR-001 20 mg|Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284931|NCT02868229|OG000|Outcome|COR-001|Participants were randomized to ziltivekimab (COR-001) or placebo within each cohort. Participants received 2 mg or 6 mg or 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients
11284932|NCT02868229|EG000|Reported Event|Placebo|Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients.
11284933|NCT02868229|EG001|Reported Event|COR-001 2 mg|Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284934|NCT02868229|EG002|Reported Event|COR-001 6 mg|Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284935|NCT02868229|EG003|Reported Event|COR-001 20 mg|Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients.
11284936|NCT02868242|BG000|Baseline|LDV/SOF|LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
11284937|NCT02868242|FG000|Participant Flow|LDV/SOF|LDV/SOF 90/400 mg fixed dose combination (FDC) orally once daily for 12 weeks
11284938|NCT02868242|OG000|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
11284939|NCT02868242|OG000|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC once daily for 12 weeks
11284940|NCT02868242|OG000|Outcome|LDV/SOF|LDV/SOF FDC 90/400 mg orally once daily for 12 weeks
11284941|NCT02868242|EG000|Reported Event|LDV/SOF|LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
11284942|NCT02868281|BG000|Baseline|ACT Guided Treatment Group|Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
11284943|NCT02868281|BG001|Baseline|Usual Care Group|Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
11284944|NCT02868281|BG002|Baseline|Total|Total of all reporting groups
11284945|NCT02868281|FG000|Participant Flow|ACT Guided Treatment Group|Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
11284946|NCT02868281|FG001|Participant Flow|Usual Care Group|Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
11284947|NCT02868281|OG000|Outcome|ACT Guided Treatment Group|Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
11284948|NCT02868281|OG001|Outcome|Usual Care Group|Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
11284949|NCT02868281|EG000|Reported Event|ACT Guided Treatment Group|Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
11284950|NCT02868281|EG001|Reported Event|Usual Care Group|Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
11284951|NCT02868554|BG000|Baseline|Standard Invisalign Therapy|Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
11092464|NCT01540045|OG000|Outcome|Pre-chemotherapy Patientes|patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
11284952|NCT02868554|BG001|Baseline|Accelerated Invisalign|"Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284953|NCT02868554|BG002|Baseline|Accelerated Invisalign and Vibration|"In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.~AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284954|NCT02868554|BG003|Baseline|Total|Total of all reporting groups
11284955|NCT02868554|FG000|Participant Flow|Standard Invisalign Therapy|Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
11284956|NCT02868554|FG001|Participant Flow|Accelerated Invisalign|"Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284957|NCT02868554|FG002|Participant Flow|Accelerated Invisalign and Vibration|"In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.~AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284958|NCT02868554|OG000|Outcome|Standard Invisalign Therapy|Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
11284959|NCT02868554|OG001|Outcome|Accelerated Invisalign|"Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284960|NCT02868554|OG002|Outcome|Accelerated Invisalign and Vibration|"In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.~AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284961|NCT02868554|EG000|Reported Event|Standard Invisalign Therapy|Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
11284962|NCT02868554|EG001|Reported Event|Accelerated Invisalign|"Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284963|NCT02868554|EG002|Reported Event|Accelerated Invisalign and Vibration|"In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.~AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.~Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear."
11284964|NCT02869295|BG000|Baseline|NKTR-214 0.003 mg/kg q21d|NKTR-214 given at a dose of 0.003 mg/kg every 21 days
11284965|NCT02869295|BG001|Baseline|NKTR-214 0.006 mg/kg q21d|NKTR-214 given at a dose of 0.006 mg/kg every 21 days
11284966|NCT02869295|BG002|Baseline|NKTR-214 0.006 mg/kg q14d|NKTR-214 given at a dose of 0.006 mg/kg every 14 days
11284967|NCT02869295|BG003|Baseline|NKTR-214 0.009 mg/kg q21d|NKTR-214 given at a dose of 0.009 mg/kg every 21 days
11284968|NCT02869295|BG004|Baseline|NKTR-214 0.012 mg/kg q21d|NKTR-214 given at a dose of 0.012 mg/kg every 21 days
11284969|NCT02869295|BG005|Baseline|Total|Total of all reporting groups
11284970|NCT02869295|FG000|Participant Flow|NKTR-214 0.003 mg/kg q21d|This group will be given NKTR-214 at a dose of 0.003 mg/kg every 21 days
11284971|NCT02869295|FG001|Participant Flow|NKTR-214 0.006 mg/kg q21d|This group will be given NKTR-214 at a dose of 0.006 mg/kg every 21 days
11284972|NCT02869295|FG002|Participant Flow|NKTR-214 0.006 mg/kg q14d|This group will be given NKTR-214 at a dose of 0.006 mg/kg every 14 days
11284973|NCT02869295|FG003|Participant Flow|NKTR-214 0.009 mg/kg q21d|This group will be given NKTR-214 at a dose of 0.009 mg/kg every 21 days
11284974|NCT02869295|FG004|Participant Flow|NKTR-214 0.012 mg/kg q21d|This group will be given NKTR-214 at a dose of 0.012 mg/kg every 21 days
11284975|NCT02869295|OG000|Outcome|NKTR-214 0.003 mg/kg q21d|NKTR-214 given at a dose of 0.003 mg/kg every 21 days
11284976|NCT02869295|OG001|Outcome|NKTR-214 0.006 mg/kg q21d|NKTR-214 given at a dose of 0.006 mg/kg every 21 days
11284977|NCT02869295|OG002|Outcome|NKTR-214 0.006 mg/kg q14d|NKTR-214 given at a dose of 0.006 mg/kg every 14 days
11284978|NCT02869295|OG003|Outcome|NKTR-214 0.009 mg/kg q21d|NKTR-214 given at a dose of 0.009 mg/kg every 21 days
11284979|NCT02869295|OG004|Outcome|NKTR-214 0.012 mg/kg q21d|NKTR-214 given at a dose of 0.012 mg/kg every 21 days
11284980|NCT02869295|EG000|Reported Event|NKTR-214 0.003 mg/kg q21d|NKTR-214 given at a dose of 0.003 mg/kg every 21 days
11284981|NCT02869295|EG001|Reported Event|NKTR-214 0.006 mg/kg q21d|NKTR-214 given at a dose of 0.006 mg/kg every 21 days
11284982|NCT02869295|EG002|Reported Event|NKTR-214 0.006 mg/kg q14d|NKTR-214 given at a dose of 0.006 mg/kg every 14 days
11284983|NCT02869295|EG003|Reported Event|NKTR-214 0.009 mg/kg q21d|NKTR-214 given at a dose of 0.009 mg/kg every 21 days
11284984|NCT02869295|EG004|Reported Event|NKTR-214 0.012 mg/kg q21d|NKTR-214 given at a dose of 0.012 mg/kg every 21 days
11284985|NCT02869334|BG000|Baseline|Auditory Remediation With Active tDCS|"Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284986|NCT02869334|BG001|Baseline|Auditory Remediation With Sham tDCS|"Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284987|NCT02869334|BG002|Baseline|Total|Total of all reporting groups
11284988|NCT02869334|FG000|Participant Flow|Auditory Remediation With Active tDCS|"Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284989|NCT02869334|FG001|Participant Flow|Auditory Remediation With Sham tDCS|"Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284990|NCT02869334|OG000|Outcome|Auditory Remediation With Active tDCS|"Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284991|NCT02869334|OG001|Outcome|Auditory Remediation With Sham tDCS|"Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284992|NCT02869334|EG000|Reported Event|Auditory Remediation With Active tDCS|"Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284993|NCT02869334|EG001|Reported Event|Auditory Remediation With Sham tDCS|"Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week~Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS~Auditory Remediation: Computer program designed to improve discrimination between sounds"
11284994|NCT02869438|BG000|Baseline|Benra 30 mg|12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11284995|NCT02869438|BG001|Baseline|Placebo|12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11092465|NCT01540045|OG001|Outcome|Post-chemotherapy Patients|patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
11284996|NCT02869438|BG002|Baseline|Total|Total of all reporting groups
11284997|NCT02869438|FG000|Participant Flow|Benra 30 mg|12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11284998|NCT02869438|FG001|Participant Flow|Placebo|12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11284999|NCT02869438|OG000|Outcome|Benra 30 mg|12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11285000|NCT02869438|OG001|Outcome|Placebo|12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11285001|NCT02869438|EG000|Reported Event|Benra 30 mg|12-week treatment period and receive Benra 30 mg at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11285002|NCT02869438|EG001|Reported Event|Placebo|12-week treatment period and receive Placebo at Day 0, Day 28 (±3 days), and Day 56 (±3 days).
11092466|NCT01540045|EG000|Reported Event|LUNG CANCER PATIENTS|any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
11092467|NCT01540071|BG000|Baseline|NRX 194204|NRX 194204, 20 mg orally once per day
11285003|NCT02869451|BG000|Baseline|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
11092468|NCT01540071|FG000|Participant Flow|NRX 194204|NRX 194204 capsules, 20 mg PO once per day
11215221|NCT02297815|BG000|Baseline|Narrow Spectrum Antibiotics|"Child prescribed with the following at time of diagnosis:~Acute otitis media: Amoxicillin Acute sinusitis: Amoxicillin Streptococcal pharyngitis: Penicillin or Amoxicillin"
11215222|NCT02297815|BG001|Baseline|Non-narrow Spectrum Antibiotics|"Child prescribed with the following at time of diagnosis:~Acute otitis media: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Acute sinusitis: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Streptococcal pharyngitis: Amoxicillin-Clavulanate, Azithromycin, Cefadroxil, Cefdinir, Cefprozil, Cefuroxime Axetil, Cephalexin"
11215223|NCT02297815|BG002|Baseline|Total|Total of all reporting groups
11215224|NCT02297815|FG000|Participant Flow|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
11215225|NCT02297815|FG001|Participant Flow|Broad-Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
11215226|NCT02297815|OG000|Outcome|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
11215227|NCT02297815|OG001|Outcome|Broad Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
11215228|NCT02297815|OG001|Outcome|Non-narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
11215229|NCT02297815|OG001|Outcome|Broad-Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
11215230|NCT02297815|EG000|Reported Event|Narrow Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
11215231|NCT02297815|EG001|Reported Event|Broad Spectrum Antibiotic|Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
11215232|NCT02297841|BG000|Baseline|HRIPT|Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
11215233|NCT02297841|FG000|Participant Flow|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
11215234|NCT02297841|OG000|Outcome|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
11215235|NCT02297841|EG000|Reported Event|HRIPT|Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel lubricant
11215236|NCT02298023|BG000|Baseline|Mesenchymal Stem Cell Group|"Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.~allogenic adipose stem cell injection: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise."
11215237|NCT02298023|BG001|Baseline|Active Control (Fibrin Glue) Group|"Received fibrin glue and normal saline.~fibrin glue/normal saline injection: Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise"
11215238|NCT02298023|BG002|Baseline|Control (Normal Saline )Group|"Received only normal saline.~normal saline injection: Total 1cc of normal saline injection and range of motion exercise"
11215239|NCT02298023|BG003|Baseline|Total|Total of all reporting groups
11215240|NCT02298023|FG000|Participant Flow|Mesenchymal Stem Cell Group|"Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.~allogenic adipose stem cell injection: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.~Eight participants were assigned and one declined to participate before the intervention."
11215241|NCT02298023|FG001|Participant Flow|Active Control (Fibrin Glue) Group|"Received fibrin glue and normal saline.~fibrin glue/normal saline injection: Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise~Eight participants were assigned and followed up throughout the study."
11215242|NCT02298023|FG002|Participant Flow|Control (Normal Saline )Group|"Received only normal saline.~normal saline injection: Total 1cc of normal saline injection and range of motion exercise~Eight participants were assigned and followed up throughout the study except one who missed the last visit."
11215243|NCT02298023|OG000|Outcome|Mesenchymal Stem Cell Group|"Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.~allogenic adipose stem cell injection: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.~Eight participants were assigned and one declined to participate before the intervention."
11215244|NCT02298023|OG001|Outcome|Active Control (Fibrin Glue) Group|"Received fibrin glue and normal saline.~fibrin glue/normal saline injection: Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise~Eight participants were assigned and followed up throughout the study."
11215245|NCT02298023|OG002|Outcome|Control (Normal Saline )Group|"Received only normal saline.~normal saline injection: Total 1cc of normal saline injection and range of motion exercise~Eight participants were assigned and followed up throughout the study except one who missed the last visit."
11215246|NCT02298023|OG000|Outcome|Mesenchymal Stem Cell Group|Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.
11215247|NCT02298023|OG001|Outcome|Active Control (Fibrin Glue) Group|Received fibrin glue and normal saline.
11215248|NCT02298023|OG002|Outcome|Control (Normal Saline )Group|Received only normal saline.
11215249|NCT02298023|EG000|Reported Event|Mesenchymal Stem Cell Group|"Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.~allogenic adipose stem cell injection: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.~Eight participants were assigned and one declined to participate before the intervention."
11285004|NCT02869451|FG000|Participant Flow|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
11285005|NCT02869451|OG000|Outcome|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
11285006|NCT02869451|EG000|Reported Event|Treatment|"Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.~bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.~transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant~Nicotine polacrilex: Initiated at smoking quit date.~nicotine lozenge: Initiated at smoking quit date.~counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention~mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana"
11285007|NCT02869893|BG000|Baseline|Healthy Participants|"Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation.~Secretin"
11285008|NCT02869893|FG000|Participant Flow|Healthy Participants|"MRCP with Secretin and MR elastography will be performed on all participants.~Secretin"
11285009|NCT02869893|OG000|Outcome|Healthy Participants|"Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation.~Secretin"
11285010|NCT02869893|OG000|Outcome|Healthy Participants|Healthy participants underwent MR elastography of the pancreas
11285011|NCT02869893|EG000|Reported Event|Healthy Participants|"MRCP with Secretin and MR elastography will be performed on all participants.~Secretin"
11285012|NCT02870101|BG000|Baseline|Intervention|Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
11285013|NCT02870101|FG000|Participant Flow|Intervention|Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
11285014|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
11285015|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
11285016|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 2 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
11285017|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 2 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
11285018|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 3 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
11285019|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 3 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
11285020|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 1 to detect Chlamydia trachomatis from swabs collected from the pharynx.
11285021|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 1 to detect Chlamydia trachomatis from swabs collected from the rectum.
11285022|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 2 to detect Chlamydia trachomatis from swabs collected from the pharynx.
11285023|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 2 to detect Chlamydia trachomatis from swabs collected from the rectum.
11285024|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 3 to detect Chlamydia trachomatis from swabs collected from the pharynx.
11285025|NCT02870101|OG000|Outcome|Intervention|Performance of nucleic acid amplification test 3 to detect Chlamydia trachomatis from swabs collected from the rectum.
11285026|NCT02870101|EG000|Reported Event|Intervention|Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
11285027|NCT02870205|BG000|Baseline|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
11285028|NCT02870205|BG001|Baseline|GSP 301 NS|2 sprays/nostril twice daily for 14 days
11285029|NCT02870205|BG002|Baseline|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
11285030|NCT02870205|BG003|Baseline|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
11285031|NCT02870205|BG004|Baseline|Total|Total of all reporting groups
11285032|NCT02870205|FG000|Participant Flow|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
11285033|NCT02870205|FG001|Participant Flow|GSP 301 NS|2 sprays/nostril twice daily for 14 days
11285034|NCT02870205|FG002|Participant Flow|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
11285035|NCT02870205|FG003|Participant Flow|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
11285036|NCT02870205|OG000|Outcome|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
11285037|NCT02870205|OG001|Outcome|GSP 301 NS|2 sprays/nostril twice daily for 14 days
11285038|NCT02870205|OG002|Outcome|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
11285039|NCT02870205|OG003|Outcome|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
11285040|NCT02870205|EG000|Reported Event|GSP 301 Placebo NS|2 sprays/nostril twice daily for 14 days
11285041|NCT02870205|EG001|Reported Event|GSP 301 NS|2 sprays/nostril twice daily for 14 days
11285042|NCT02870205|EG002|Reported Event|Olopatadine HCl NS|2 sprays/nostril twice daily for 14 days
11285043|NCT02870205|EG003|Reported Event|Mometasone Furoate NS|2 sprays/nostril twice daily for 14 days
11285044|NCT02870283|BG000|Baseline|Lithium|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (A) Started Lithium (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.~Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 3rd step.~Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Lithium"
11285045|NCT02870283|BG001|Baseline|Acid Valproic|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (B) Started Valproic Acid (1000mg-1500mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Valproic Acid"
11285046|NCT02870283|BG002|Baseline|Carbamazepine|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (C) Started Carbamazepine (600mg-1200mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Carbamazepine"
11285047|NCT02870283|BG003|Baseline|Total|Total of all reporting groups
11285048|NCT02870283|FG000|Participant Flow|Lithium|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (A) Started Lithium (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.~Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 3rd step.~Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Lithium"
11285049|NCT02870283|FG001|Participant Flow|Acid Valproic|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (B) Started Valproic Acid (1000mg-1500mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Valproic Acid"
11285050|NCT02870283|FG002|Participant Flow|Carbamazepine|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (C) Started Carbamazepine (600mg-1200mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Carbamazepine"
11285051|NCT02870283|OG000|Outcome|Lithium|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (A) Started Lithium (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.~Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 3rd step.~Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Lithium"
11337703|NCT03591406|BG000|Baseline|Ferric Carboxymaltose (FCM)|"Participants treated with FCM given by IV injection or drip infusion~Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection~Strength: 10 mL vials containing 500 mg iron per vial~Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening)~Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline)~Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15."
11285052|NCT02870283|OG001|Outcome|Acid Valproic|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (B) Started Valproic Acid (1000mg-1500mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Valproic Acid"
11285053|NCT02870283|OG002|Outcome|Carbamazepine|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (C) Started Carbamazepine (600mg-1200mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Carbamazepine"
11285054|NCT02870283|EG000|Reported Event|Lithium|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (A) Started Lithium (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.~Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 3rd step.~Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).~Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Lithium"
11285055|NCT02870283|EG001|Reported Event|Acid Valproic|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (B) Started Valproic Acid (1000mg-1500mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Valproic Acid"
11285056|NCT02870283|EG002|Reported Event|Carbamazepine|"Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).~Group (C) Started Carbamazepine (600mg-1200mg).~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.~Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.~Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.~Fourth step: Association with risperidone (1-6mg)~Carbamazepine"
11285057|NCT02870309|BG000|Baseline|Alpha-1 MP|Participants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8.
11285058|NCT02870309|FG000|Participant Flow|Alpha-1 MP|Participants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8.
11285059|NCT02870309|OG000|Outcome|Alpha-1 MP|Participants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8.
11285060|NCT02870309|EG000|Reported Event|Alpha-1 MP|Participants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8.
11285061|NCT02870933|BG000|Baseline|CABG + Transepicardial With Transseptal CD 133+ Implantation|this arm will receive Transepicardial with Transseptal CD 133+ Implantation
11285062|NCT02870933|BG001|Baseline|Control|this arm will not receive Transepicardial with Transseptal CD 133+ Implantation
11285063|NCT02870933|BG002|Baseline|Total|Total of all reporting groups
11285064|NCT02870933|FG000|Participant Flow|CABG + Transepicardial With Transseptal CD 133+ Implantation|this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
11285065|NCT02870933|FG001|Participant Flow|Control|this arm will receive CABG only
11285066|NCT02870933|OG000|Outcome|Transepicardial With Transseptal CD 133+ Implantation|this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
11285067|NCT02870933|OG001|Outcome|Control|this arm will receive CABG only
11285068|NCT02870933|OG000|Outcome|subjectTransepicardial With Transseptal CD 133+ Implantation|this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
11285069|NCT02870933|EG000|Reported Event|Subject|this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
11285070|NCT02870933|EG001|Reported Event|Control|this arm will receive CABG only
11092469|NCT01540071|OG000|Outcome|NRX 194204|"This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.~NRX 194204: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day"
11285071|NCT02870972|BG000|Baseline|Part 1: Berotralstat 350 mg|Berotralstat capsules, 350 mg dose administered once per day for 28 days
11285072|NCT02870972|BG001|Baseline|Parts 2 & 3: Berotralstat 250 mg|Berotralstat capsules, 250 mg dose administered once per day for 28 days
11285073|NCT02870972|BG002|Baseline|Parts 2 & 3: Berotralstat 125 mg|Berotralstat capsules, 125 mg dose administered once per day for 28 days
11285074|NCT02870972|BG003|Baseline|Part 3: Berotralstat 62.5 mg|Berotralstat capsules, 62.5 mg dose administered once per day for 28 days
11285075|NCT02870972|BG004|Baseline|Parts 1, 2 & 3: Placebo|Placebo capsules, administered once per day for 28 days
11285076|NCT02870972|BG005|Baseline|Total|Total of all reporting groups
11285077|NCT02870972|FG000|Participant Flow|Part 1: Berotralstat 350 mg|Berotralstat capsules, 350 mg dose administered once per day for 28 days
11092470|NCT01540071|OG000|Outcome|NRX 194204|This was a single arm open-label study. All patients enrolled and treated received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.
11285078|NCT02870972|FG001|Participant Flow|Parts 2 & 3: Berotralstat 250 mg|Berotralstat capsules, 250 mg dose administered once per day for 28 days
11285079|NCT02870972|FG002|Participant Flow|Parts 2 & 3: Berotralstat 125 mg|Berotralstat capsules, 125 mg dose administered once per day for 28 days
11285080|NCT02870972|FG003|Participant Flow|Part 3: Berotralstat 62.5 mg|Berotralstat capsules, 62.5 mg dose administered once per day for 28 days
11285081|NCT02870972|FG004|Participant Flow|Parts 1, 2 & 3: Placebo|Placebo capsules, administered once per day for 28 days
11285082|NCT02870972|OG000|Outcome|Berotralstat 350 mg|Berotralstat capsules (350 mg) administered QD for 28 days
11285083|NCT02870972|OG001|Outcome|Berotralstat 250 mg|Berotralstat capsules (250 mg) administered QD for 28 days
11285084|NCT02870972|OG002|Outcome|Berotralstat 125 mg|Berotralstat capsules (125 mg) administered QD for 28 days
11285085|NCT02870972|OG003|Outcome|Berotralstat 62.5 mg|Berotralstat capsules (62.5 mg) administered QD for 28 days
11285086|NCT02870972|OG004|Outcome|Berotralstat|Berotralstat capsules administered QD for 28 days
11285087|NCT02870972|OG005|Outcome|Placebo|Placebo capsules administered QD for 28 days
11285088|NCT02870972|OG004|Outcome|Placebo|Placebo capsules administered QD for 28 days
11285089|NCT02870972|EG000|Reported Event|Berotralstat 350 mg|Berotralstat capsules (350 mg) administered QD for 28 days
11285090|NCT02870972|EG001|Reported Event|Berotralstat 250 mg|Berotralstat capsules (250 mg) administered QD for 28 days
11285091|NCT02870972|EG002|Reported Event|Berotralstat 125 mg|Berotralstat capsules (125 mg) administered QD for 28 days
11285092|NCT02870972|EG003|Reported Event|Berotralstat 62.5 mg|Berotralstat capsules (62.5 mg) administered QD for 28 days
11285093|NCT02870972|EG004|Reported Event|Placebo|Placebo capsules administered QD for 28 days
11285094|NCT02871011|BG000|Baseline|Control|"Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Water: Delivered as a footbath"
11285095|NCT02871011|BG001|Baseline|Nitric Oxide|"Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Nitric Oxide: Delivered as a footbath"
11285096|NCT02871011|BG002|Baseline|Total|Total of all reporting groups
11285097|NCT02871011|FG000|Participant Flow|Control|"Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Water: Delivered as a footbath"
11285098|NCT02871011|FG001|Participant Flow|Nitric Oxide|"Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Nitric Oxide: Delivered as a footbath"
11285099|NCT02871011|OG000|Outcome|Control|"Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Water: Delivered as a footbath"
11285100|NCT02871011|OG001|Outcome|Nitric Oxide|"Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Nitric Oxide: Delivered as a footbath"
11285101|NCT02871011|EG000|Reported Event|Control|"Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Water: Delivered as a footbath"
11285102|NCT02871011|EG001|Reported Event|Nitric Oxide|"Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.~Nitric Oxide: Delivered as a footbath"
11285103|NCT02871128|BG000|Baseline|Natureheme-iron|"Subjects receive 2 capsules per day containing either 1000 mg Fe.~Natureheme-iron: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285104|NCT02871128|BG001|Baseline|Placebo|"Subjects receive 2 capsules per day containing starch placebo of similar appearance.~Placebo: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285105|NCT02871128|BG002|Baseline|Supplement|"Subjects receive 1 capsule per day containing either 100 mg Fe.~supplement: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285106|NCT02871128|BG003|Baseline|Total|Total of all reporting groups
11285107|NCT02871128|FG000|Participant Flow|Natureheme-iron|"Subjects receive 2 capsules per day containing either 1000 mg Fe.~Natureheme-iron: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285108|NCT02871128|FG001|Participant Flow|Placebo|"Subjects receive 2 capsules per day containing starch placebo of similar appearance.~Placebo: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285109|NCT02871128|FG002|Participant Flow|Supplement|"Subjects receive 1 capsule per day containing either 100 mg Fe.~supplement: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285110|NCT02871128|OG000|Outcome|Natureheme-iron|"Subjects receive 2 capsules per day containing either 1000 mg Fe.~Natureheme-iron: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285111|NCT02871128|OG001|Outcome|Placebo|"Subjects receive 2 capsules per day containing starch placebo of similar appearance.~Placebo: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285112|NCT02871128|OG002|Outcome|Supplement|"Subjects receive 1 capsule per day containing either 100 mg Fe.~supplement: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285113|NCT02871128|EG000|Reported Event|Natureheme-iron|"Subjects receive 2 capsules per day containing either 1000 mg Fe.~Natureheme-iron: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285114|NCT02871128|EG001|Reported Event|Placebo|"Subjects receive 2 capsules per day containing starch placebo of similar appearance.~Placebo: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285115|NCT02871128|EG002|Reported Event|Supplement|"Subjects receive 1 capsule per day containing either 100 mg Fe.~supplement: An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls."
11285116|NCT02871375|BG000|Baseline|Overall|Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment.
11285117|NCT02871375|FG000|Participant Flow|DT1 MF / Habitual MF|Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
11285118|NCT02871375|FG001|Participant Flow|Habitual MF / DT1 MF|Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
11285119|NCT02871375|OG000|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
11285120|NCT02871375|OG001|Outcome|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
11285121|NCT02871375|OG001|Outcome|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
11285122|NCT02871375|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to study lenses dispensed for 14-day wear
11285123|NCT02871375|EG001|Reported Event|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2
11285124|NCT02871375|EG002|Reported Event|Habitual MF|Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
11285125|NCT02871440|BG000|Baseline|Eye Drop 1|Omega 3
11285126|NCT02871440|BG001|Baseline|Eye Drop 2|Optive Advanced
11285127|NCT02871440|BG002|Baseline|Eye Drop 3|Optive
11285128|NCT02871440|BG003|Baseline|Total|Total of all reporting groups
11285129|NCT02871440|FG000|Participant Flow|Eye Drop 1|Omega 3 Tear Formulation (1-2 drops in each eye for at least 2 times daily)
11285130|NCT02871440|FG001|Participant Flow|Eye Drop 2|Optive Advanced (1-2 drops in each eye for at least 2 times daily)
11285131|NCT02871440|FG002|Participant Flow|Eye Drop 3|Optive (1-2 drops in each eye for at least 2 times daily)
11285132|NCT02871440|OG000|Outcome|Eye Drop 1|Omega 3
11285133|NCT02871440|OG001|Outcome|Eye Drop 2|Optive Advanced
11285134|NCT02871440|OG002|Outcome|Eye Drop 3|Optive
11285135|NCT02871440|OG000|Outcome|Eye Drop 1|"Omega 3~Omega 3"
11285136|NCT02871440|OG001|Outcome|Eye Drop 2|"Optive Advanced~Optive Advanced"
10970607|NCT00911157|EG001|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
11285137|NCT02871440|OG002|Outcome|Eye Drop 3|"Optive~Optive"
11285138|NCT02871440|EG000|Reported Event|Eye Drop 1|Omega 3
11285139|NCT02871440|EG001|Reported Event|Eye Drop 2|Optive Advanced
11285140|NCT02871440|EG002|Reported Event|Eye Drop 3|Optive
11285141|NCT02871479|BG000|Baseline|SAN007 5% Cream|"A cream containing 5% East Indian sandalwood oil (EISO).~SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days."
11285142|NCT02871479|BG001|Baseline|Placebo Cream|"The vehicle cream~Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm"
11285143|NCT02871479|BG002|Baseline|SAN007 10% Cream|"A cream containing 10% East Indian Sandalwood Oil (EISO).~SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days."
11285144|NCT02871479|BG003|Baseline|Total|Total of all reporting groups
11285145|NCT02871479|FG000|Participant Flow|SAN007 5% Cream|"A cream containing 5% East Indian sandalwood oil (EISO).~SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days."
11285146|NCT02871479|FG001|Participant Flow|Placebo Cream|"The vehicle cream~Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm"
11285147|NCT02871479|FG002|Participant Flow|SAN007 10% Cream|"A cream containing 10% East Indian Sandalwood Oil (EISO).~SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days."
11285148|NCT02871479|OG000|Outcome|SAN007 5% Cream|"A cream containing 5% East Indian sandalwood oil (EISO).~SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days."
11285149|NCT02871479|OG001|Outcome|Placebo Cream|"The vehicle cream~Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm"
11285150|NCT02871479|OG002|Outcome|SAN007 10% Cream|"A cream containing 10% East Indian Sandalwood Oil (EISO).~SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days."
11285151|NCT02871479|EG000|Reported Event|SAN007 5% Cream|"A cream containing 5% East Indian sandalwood oil (EISO).~SAN007 5% cream: 5% EISO in a cream formulation applied twice a day for up to 28 days."
11285152|NCT02871479|EG001|Reported Event|Placebo Cream|"The vehicle cream~Placebo: A placebo cream containing the same components as the vehicle for the active intervention arm"
11285153|NCT02871479|EG002|Reported Event|SAN007 10% Cream|"A cream containing 10% East Indian Sandalwood Oil (EISO).~SAN007 10% cream: 10% EISO in a cream formulation applied twice a day for up to 28 days."
11285154|NCT02871492|BG000|Baseline|Pritelivir 5% w/w Ointment|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir 5% w/w ointment"
11285155|NCT02871492|BG001|Baseline|Pritelivir Ointment Matching Placebo|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir ointment matching placebo"
11285156|NCT02871492|BG002|Baseline|Zovirax® Cream|"Topical treatment (20 applications), 5 times daily for 4 days~Zovirax® cream"
11285157|NCT02871492|BG003|Baseline|Total|Total of all reporting groups
11285158|NCT02871492|FG000|Participant Flow|Pritelivir 5% w/w Ointment|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir 5% w/w ointment"
11285159|NCT02871492|FG001|Participant Flow|Pritelivir Ointment Matching Placebo|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir ointment matching placebo"
11285160|NCT02871492|FG002|Participant Flow|Zovirax® Cream|"Topical treatment (20 applications), 5 times daily for 4 days~Zovirax® cream"
11285161|NCT02871492|OG000|Outcome|Pritelivir 5% w/w Ointment|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir 5% w/w ointment"
11285162|NCT02871492|OG001|Outcome|Pritelivir Ointment Matching Placebo|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir ointment matching placebo"
10970608|NCT00911170|BG000|Baseline|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
11285163|NCT02871492|OG002|Outcome|Zovirax® Cream|"Topical treatment (20 applications), 5 times daily for 4 days~Zovirax® cream"
11285164|NCT02871492|EG000|Reported Event|Pritelivir 5% w/w Ointment|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir 5% w/w ointment"
11285165|NCT02871492|EG001|Reported Event|Pritelivir Ointment Matching Placebo|"Topical treatment (20 applications), 5 times daily for 4 days~Pritelivir ointment matching placebo"
11285166|NCT02871492|EG002|Reported Event|Zovirax® Cream|"Topical treatment (20 applications), 5 times daily for 4 days~Zovirax® cream"
11285167|NCT02871570|BG000|Baseline|Moderate Hepatic Impairment Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with moderate hepatic impairment.
11285168|NCT02871570|BG001|Baseline|Normal Hepatic Function Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with normal hepatic function.
11285169|NCT02871570|BG002|Baseline|Total|Total of all reporting groups
11285170|NCT02871570|FG000|Participant Flow|Moderate Hepatic Impairment Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with moderate hepatic impairment.
11285171|NCT02871570|FG001|Participant Flow|Normal Hepatic Function Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with normal hepatic function.
11285172|NCT02871570|OG000|Outcome|Moderate Hepatic Impairment Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with moderate hepatic impairment.
11285173|NCT02871570|OG001|Outcome|Normal Hepatic Function Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with normal hepatic function.
11285174|NCT02871570|EG000|Reported Event|Moderate Hepatic Impairment Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with moderate hepatic impairment.
11285175|NCT02871570|EG001|Reported Event|Normal Hepatic Function Group|A single dose of rivipansel 840 mg was administered intravenously (IV) to a group of participants with normal hepatic function.
11285176|NCT02871635|BG000|Baseline|BI 695501|"Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).~Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."
11285177|NCT02871635|BG001|Baseline|Humira EU|"Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).~Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection."
11285178|NCT02871635|BG002|Baseline|Total|Total of all reporting groups
11285179|NCT02871635|FG000|Participant Flow|BI 695501|"Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).~Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."
11285180|NCT02871635|FG001|Participant Flow|Humira EU|"Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).~Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection."
11285181|NCT02871635|OG000|Outcome|BI 695501|"Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).~Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."
11285182|NCT02871635|OG001|Outcome|Humira EU|"Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).~Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection."
11285183|NCT02871635|EG000|Reported Event|BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])|"Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).~Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."
11285184|NCT02871635|EG001|Reported Event|Humira (Baseline - Week 24 + 10 Weeks [70 Days])|"Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).~Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection."
11285185|NCT02871635|EG002|Reported Event|BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])|"Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).~Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection."
11285186|NCT02871635|EG003|Reported Event|Humira (Week 24 - Week 46 + 10 Weeks [70 Days])|"Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).~Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection."
11285187|NCT02871739|BG000|Baseline|DA Viewing With SPI Feedback|"Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~DA viewing: Participants will receive 3 decisions aids to review.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285188|NCT02871739|BG001|Baseline|DA Viewing With no SPI Feedback|"Group 2 receives three decision aids. This group does not receive any feedback from the SPI.~DA viewing: Participants will receive 3 decisions aids to review."
11285189|NCT02871739|BG002|Baseline|Webinar With SPI Feedback|"Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285190|NCT02871739|BG003|Baseline|Webinar With no SPI Feedback|"Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters."
11285191|NCT02871739|BG004|Baseline|Total|Total of all reporting groups
11285192|NCT02871739|FG000|Participant Flow|DA Viewing With SPI Feedback|"Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~DA viewing: Participants will receive 3 decisions aids to review.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285193|NCT02871739|FG001|Participant Flow|DA Viewing With no SPI Feedback|"Group 2 receives three decision aids. This group does not receive any feedback from the SPI.~DA viewing: Participants will receive 3 decisions aids to review."
11285194|NCT02871739|FG002|Participant Flow|Webinar With SPI Feedback|"Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285195|NCT02871739|FG003|Participant Flow|Webinar With no SPI Feedback|"Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters."
11285196|NCT02871739|OG000|Outcome|DA Viewing With SPI Feedback|"Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~DA viewing: Participants will receive 3 decisions aids to review.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285197|NCT02871739|OG001|Outcome|DA Viewing With no SPI Feedback|"Group 2 receives three decision aids. This group does not receive any feedback from the SPI.~DA viewing: Participants will receive 3 decisions aids to review."
11285198|NCT02871739|OG002|Outcome|Webinar With SPI Feedback|"Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285199|NCT02871739|OG003|Outcome|Webinar With no SPI Feedback|"Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters."
11285200|NCT02871739|EG000|Reported Event|DA Viewing With SPI Feedback|"Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~DA viewing: Participants will receive 3 decisions aids to review.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285201|NCT02871739|EG001|Reported Event|DA Viewing With no SPI Feedback|"Group 2 receives three decision aids. This group does not receive any feedback from the SPI.~DA viewing: Participants will receive 3 decisions aids to review."
11285202|NCT02871739|EG002|Reported Event|Webinar With SPI Feedback|"Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.~SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction"
11285203|NCT02871739|EG003|Reported Event|Webinar With no SPI Feedback|"Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.~Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters."
11285204|NCT02872012|BG000|Baseline|Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285205|NCT02872012|BG001|Baseline|Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285206|NCT02872012|BG002|Baseline|Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285207|NCT02872012|BG003|Baseline|Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285208|NCT02872012|BG004|Baseline|Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285209|NCT02872012|BG005|Baseline|Total|Total of all reporting groups
11285210|NCT02872012|FG000|Participant Flow|Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285211|NCT02872012|FG001|Participant Flow|Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.."
11285212|NCT02872012|FG002|Participant Flow|Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285213|NCT02872012|FG003|Participant Flow|Cyroanesthesia Device -10 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285214|NCT02872012|FG004|Participant Flow|Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285215|NCT02872012|OG000|Outcome|Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285216|NCT02872012|OG001|Outcome|Cyroanesthesia Device -5 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285217|NCT02872012|OG002|Outcome|Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285218|NCT02872012|OG003|Outcome|Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285219|NCT02872012|OG004|Outcome|Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285220|NCT02872012|OG005|Outcome|Standard of Care: Lidocaine|"Participants randomized to this arm will have their other eye receive anesthesia via the current standard of care treatment method (lidocaine) prior to receiving an intravitreal injection.~Lidocaine: Lidocaine will be applied to the non-cryoanesthesia eye."
11285221|NCT02872012|EG000|Reported Event|Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds."
11285222|NCT02872012|EG001|Reported Event|Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds."
11337704|NCT03591406|BG001|Baseline|Iron Sucrose (IS)|"Participants treated with IS given by IV injection or drip infusion~Dosage Form: Sterile solution for injection containing 2% w/v iron~Strength: 5 mL ampoules containing 100 mg iron per ampoule~Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given~Route of administration: IV injection or drip infusion~Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose."
11337705|NCT03591406|BG002|Baseline|Total|Total of all reporting groups
11215250|NCT02298023|EG001|Reported Event|Active Control (Fibrin Glue) Group|"Received fibrin glue and normal saline.~fibrin glue/normal saline injection: Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise~Eight participants were assigned and followed up throughout the study."
11215251|NCT02298023|EG002|Reported Event|Control (Normal Saline )Group|"Received only normal saline.~normal saline injection: Total 1cc of normal saline injection and range of motion exercise~Eight participants were assigned and followed up throughout the study except one who missed the last visit."
11215252|NCT02298179|BG000|Baseline|RSV F 45 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
11215253|NCT02298179|BG001|Baseline|RSV F 45 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
11215254|NCT02298179|BG002|Baseline|RSV F 45 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
11215255|NCT02298179|BG003|Baseline|Placebo 1 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
11215256|NCT02298179|BG004|Baseline|RSV F 90 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
11215257|NCT02298179|BG005|Baseline|RSV F 90 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
11215258|NCT02298179|BG006|Baseline|RSV F 90 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
11215259|NCT02298179|BG007|Baseline|Placebo 2 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
11215260|NCT02298179|BG008|Baseline|RSV F 135 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
11215261|NCT02298179|BG009|Baseline|RSV F 135 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
11215262|NCT02298179|BG010|Baseline|RSV F 135 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
11215263|NCT02298179|BG011|Baseline|Placebo 3 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
11215264|NCT02298179|BG012|Baseline|Total|Total of all reporting groups
11215265|NCT02298179|FG000|Participant Flow|RSV F 45 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
11215266|NCT02298179|FG001|Participant Flow|RSV F 45 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
11215267|NCT02298179|FG002|Participant Flow|RSV F 45 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
11215268|NCT02298179|FG003|Participant Flow|Placebo 1 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
11215269|NCT02298179|FG004|Participant Flow|RSV F 90 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
11215270|NCT02298179|FG005|Participant Flow|RSV F 90 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
11215271|NCT02298179|FG006|Participant Flow|RSV F 90 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
11215272|NCT02298179|FG007|Participant Flow|Placebo 2 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
11215273|NCT02298179|FG008|Participant Flow|RSV F 135 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
11285223|NCT02872012|EG002|Reported Event|Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds."
11285224|NCT02872012|EG003|Reported Event|Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds."
11285225|NCT02872012|EG004|Reported Event|Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds|"All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.~Comment: Cryoanesthesia Device is the name of the device.~Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.~Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds."
11285226|NCT02872012|EG005|Reported Event|Standard of Care: Lidocaine Gel|"Participants randomized to this arm will have their other eye receive anesthesia via one current standard of care treatment method (lidocaine gel) prior to receiving an intravitreal injection.~Lidocaine gel: Lidocaine gel applied to the non-cryoanesthesia eye."
11285227|NCT02872103|BG000|Baseline|F-627|F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
11285228|NCT02872103|BG001|Baseline|Placebo|Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
11285229|NCT02872103|BG002|Baseline|Total|Total of all reporting groups
11285230|NCT02872103|FG000|Participant Flow|F-627|F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
11285231|NCT02872103|FG001|Participant Flow|Placebo|Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
11285232|NCT02872103|OG000|Outcome|F-627|F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
11285233|NCT02872103|OG001|Outcome|Placebo|Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
11285234|NCT02872103|EG000|Reported Event|Cycle 1 F-627|F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
11285235|NCT02872103|EG001|Reported Event|Cycle 1 Placebo|Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1
11285236|NCT02872103|EG002|Reported Event|All 4 Cycles F-627|F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
11285237|NCT02872103|EG003|Reported Event|Cycle 1 Placebo and Cycle 2-4 F-627|Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
11285238|NCT02872142|BG000|Baseline|Albutein 5%|PEs with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant.
11285239|NCT02872142|FG000|Participant Flow|Albutein 5%|Plasma exchanges (PEs) with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant.
11285240|NCT02872142|OG000|Outcome|Albutein 5%|PEs with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant.
11285241|NCT02872142|EG000|Reported Event|Albutein 5%|Plasma exchanges (PEs) with Albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of Albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant.
11285242|NCT02872285|BG000|Baseline|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 12 weeks~Drug: LYC-30937-EC"
11285243|NCT02872285|BG001|Baseline|Matching Placebo PO QD|"Placebo enteric coated (EC) by mouth once daily for 12 weeks~Placebo"
11285244|NCT02872285|BG002|Baseline|Total|Total of all reporting groups
11285245|NCT02872285|FG000|Participant Flow|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 12 weeks~Drug: LYC-30937-EC"
11285246|NCT02872285|FG001|Participant Flow|Matching Placebo PO QD|"Placebo enteric coated (EC) by mouth once daily for 12 weeks~Placebo"
11285247|NCT02872285|OG000|Outcome|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 12 weeks~Drug: LYC-30937-EC"
11285248|NCT02872285|OG001|Outcome|Matching Placebo PO QD|"Placebo enteric coated (EC) by mouth once daily for 12 weeks~Placebo"
11285249|NCT02872285|EG000|Reported Event|LYC-30937-EC 25 mg PO QD|"LYC-30937-EC 25 mg by mouth once daily for 12 weeks~Drug: LYC-30937-EC"
11285250|NCT02872285|EG001|Reported Event|Matching Placebo PO QD|"Placebo enteric coated (EC) by mouth once daily for 12 weeks~Placebo"
11285251|NCT02872311|BG000|Baseline|High Dose Influenza Vaccine|"This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285252|NCT02872311|BG001|Baseline|Adjuvanted Influenza Vaccine|"This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285253|NCT02872311|BG002|Baseline|Standard Dose Influenza Vaccine+HD|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants"
11285254|NCT02872311|BG003|Baseline|Standard Dose Influenza Vaccine +Adj|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants"
11285255|NCT02872311|BG004|Baseline|Standard Dose Influenza Vaccine+Recomb|"This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants~Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants"
11285256|NCT02872311|BG005|Baseline|Total|Total of all reporting groups
11285257|NCT02872311|FG000|Participant Flow|High Dose Influenza Vaccine|"This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285258|NCT02872311|FG001|Participant Flow|Adjuvanted Influenza Vaccine|"This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285259|NCT02872311|FG002|Participant Flow|Standard+High Dose|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and high dose influenza vaccination (0.5mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285260|NCT02872311|FG003|Participant Flow|Standard+Adjuvanted|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285261|NCT02872311|FG004|Participant Flow|Standard+Recombinant|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants"
11285262|NCT02872311|OG000|Outcome|High Dose Influenza Vaccine|This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
11285263|NCT02872311|OG001|Outcome|Adjuvanted Influenza Vaccine|This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
11285264|NCT02872311|OG000|Outcome|IIV-ADJ|2015-16 Standard dose vaccine recipient who received adjuvanted vaccine in the study in 2016-17
11285265|NCT02872311|OG001|Outcome|IIV-HD|2015-16 Standard dose vaccine recipient who received high dose vaccine in the study in 2016-17
11285266|NCT02872311|OG002|Outcome|None-ADJ|2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17
11285267|NCT02872311|OG003|Outcome|None-HD|2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17
11285268|NCT02872311|OG000|Outcome|Standard Dose Influenza Vaccine +Adj|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285269|NCT02872311|OG001|Outcome|Standard Dose Influenza Vaccine+HD|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285270|NCT02872311|OG002|Outcome|Standard Dose Influenza Vaccine+Recomb|"This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants"
11285271|NCT02872311|OG000|Outcome|Adjuvant Influenza Vaccine|"This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285272|NCT02872311|OG001|Outcome|High Dose Influenza Vaccine|"This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285273|NCT02872311|OG002|Outcome|Standard Dose Influenza Vaccine +Adj|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285274|NCT02872311|OG003|Outcome|Standard Dose Influenza Vaccine+HD|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285275|NCT02872311|OG000|Outcome|High Dose Influenza Vaccine|This group received High Dose vaccine in the first year of the study.
11285276|NCT02872311|OG001|Outcome|Adjuvanted Influenza Vaccine|This group received adjuvanted vaccine in the first year of the study.
11285277|NCT02872311|OG002|Outcome|Standard Dose Influenza Vaccine|This group received standard dose in the first year of the study.
11285278|NCT02872311|OG000|Outcome|High Dose Influenza Vaccine|"This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285279|NCT02872311|OG001|Outcome|Adjuvanted Influenza Vaccine|"This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285280|NCT02872311|OG002|Outcome|Standard+High Dose|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and high dose influenza vaccination (0.5mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285281|NCT02872311|OG003|Outcome|Standard+Adjuvanted|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285282|NCT02872311|OG004|Outcome|Standard+Recombinant|"This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants.~Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants"
11285283|NCT02872311|EG000|Reported Event|High Dose Influenza Vaccine|"This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants"
11285284|NCT02872311|EG001|Reported Event|Adjuvanted Influenza Vaccine|"This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants"
11285285|NCT02872311|EG002|Reported Event|Standard Dose Influenza Vaccine+HD|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.~High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants"
11285286|NCT02872311|EG003|Reported Event|Standard Dose Influenza Vaccine +Adj|"This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants"
11285287|NCT02872311|EG004|Reported Event|Standard Dose Influenza Vaccine+Recomb|"This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.~Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants~Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants"
11285288|NCT02872857|BG000|Baseline|Galantamine|8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
11285289|NCT02872857|BG001|Baseline|Placebo|Placebo: Placebo will match drug capsules.
11285290|NCT02872857|BG002|Baseline|Total|Total of all reporting groups
11285291|NCT02872857|FG000|Participant Flow|Galantamine 8mg During Phase 1|8mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
11285292|NCT02872857|FG001|Participant Flow|Placebo During Phase 1|Placebo: Placebo will match drug capsules.
11285293|NCT02872857|FG002|Participant Flow|Galantamine 12mg During Phase 2|12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
11285294|NCT02872857|FG003|Participant Flow|Placebo During Phase 2|Placebo: Placebo will match drug capsules.
11285295|NCT02872857|OG000|Outcome|Galantamine|8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
11285296|NCT02872857|OG001|Outcome|Placebo|Placebo: Placebo will match drug capsules.
11285297|NCT02872857|EG000|Reported Event|Galantamine|8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
11285298|NCT02872857|EG001|Reported Event|Placebo|Placebo: Placebo will match drug capsules.
11285299|NCT02872909|BG000|Baseline|Low Irradiance LED PDT|"Ambulight LED portable PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285300|NCT02872909|BG001|Baseline|Conventional Higher Irradiance LED|"Conventional LED hospital based standard PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285301|NCT02872909|BG002|Baseline|Total|Total of all reporting groups
11285302|NCT02872909|FG000|Participant Flow|Low Irradiance LED PDT|"Ambulight LED portable PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285303|NCT02872909|FG001|Participant Flow|Conventional Higher Irradiance LED|"Conventional LED hospital based standard PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285304|NCT02872909|OG000|Outcome|Low Irradiance LED PDT|"Ambulight LED portable PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285305|NCT02872909|OG001|Outcome|Conventional Higher Irradiance LED|"Conventional LED hospital based standard PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285306|NCT02872909|EG000|Reported Event|Low Irradiance LED PDT|"Ambulight LED portable PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285307|NCT02872909|EG001|Reported Event|Conventional Higher Irradiance LED|"Conventional LED hospital based standard PDT treatment~Ambulight (Ambicare Health): battery-operated low irradiance red light LED (skin cancer plaster)"
11285308|NCT02872935|BG000|Baseline|Placebo: Normal Saline|"1ml of Normal Saline will be given intravenously with the administering of the spinal dose~Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose"
11285309|NCT02872935|BG001|Baseline|Glycopyrrolate Group|"1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose~Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose"
11285310|NCT02872935|BG002|Baseline|Total|Total of all reporting groups
11285311|NCT02872935|FG000|Participant Flow|Placebo: Normal Saline|"1ml of Normal Saline will be given intravenously with the administering of the spinal dose~Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose"
11285312|NCT02872935|FG001|Participant Flow|Glycopyrrolate Group|"1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose~Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose"
11285313|NCT02872935|OG000|Outcome|Placebo: Normal Saline|"1ml of Normal Saline will be given intravenously with the administering of the spinal dose~Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose"
11285314|NCT02872935|OG001|Outcome|Glycopyrrolate Group|"1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose~Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose"
11285315|NCT02872935|EG000|Reported Event|Placebo: Normal Saline|"1ml of Normal Saline will be given intravenously with the administering of the spinal dose~Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose"
11285316|NCT02872935|EG001|Reported Event|Glycopyrrolate Group|"1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose~Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose"
11285317|NCT02873104|BG000|Baseline|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
11285318|NCT02873104|BG001|Baseline|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
11285319|NCT02873104|BG002|Baseline|Total|Total of all reporting groups
11285320|NCT02873104|FG000|Participant Flow|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
11285321|NCT02873104|FG001|Participant Flow|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
11285322|NCT02873104|OG000|Outcome|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
11285323|NCT02873104|OG001|Outcome|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
11285324|NCT02873104|EG000|Reported Event|Treatment|"truSculpt rf device, therapeutic settings~truSculpt rf device: radiofrequency device"
11285325|NCT02873104|EG001|Reported Event|Sham|"truSculpt rf device, non-therapeutic settings~truSculpt rf device: radiofrequency device"
11285326|NCT02873208|BG000|Baseline|ALKS 3831|"All subjects assigned to ALKS 3831~ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan~Oral tablet, daily dosing"
11285327|NCT02873208|FG000|Participant Flow|ALKS 3831|"All subjects assigned to ALKS 3831~ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan~Oral tablet, daily dosing"
11285328|NCT02873208|OG000|Outcome|ALKS 3831|"All subjects assigned to ALKS 3831~ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan~Oral tablet, daily dosing"
11285329|NCT02873208|EG000|Reported Event|ALKS 3831|"All subjects assigned to ALKS 3831 in ALKS 3831-A303 and ALKS 3831-A304~ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan~Oral tablet, daily dosing"
11285330|NCT02873221|BG000|Baseline|Usual Care|Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
11285331|NCT02873221|BG001|Baseline|Ubrogepant 50 mg|Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285332|NCT02873221|BG002|Baseline|Ubrogepant 100 mg|Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285333|NCT02873221|BG003|Baseline|Total|Total of all reporting groups
11285334|NCT02873221|FG000|Participant Flow|Usual Care|Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
11285335|NCT02873221|FG001|Participant Flow|Ubrogepant 50 mg|Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285336|NCT02873221|FG002|Participant Flow|Ubrogepant 100 mg|Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285337|NCT02873221|OG000|Outcome|Usual Care|Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
11285338|NCT02873221|OG001|Outcome|Ubrogepant 50 mg|Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285339|NCT02873221|OG002|Outcome|Ubrogepant 100 mg|Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285340|NCT02873221|EG000|Reported Event|Usual Care|Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
11285341|NCT02873221|EG001|Reported Event|Ubrogepant 50 mg|Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285342|NCT02873221|EG002|Reported Event|Ubrogepant 100 mg|Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
11285343|NCT02873286|BG000|Baseline|Group 1 - Single Low Dose / Booster|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285344|NCT02873286|BG001|Baseline|Group 2 - Two Low Doses|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285345|NCT02873286|BG002|Baseline|Group 3 - Single High Dose / Booster|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285346|NCT02873286|BG003|Baseline|Group 4 - Two High Doses|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
10822112|NCT00074490|OG004|Outcome|Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)|Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
11285347|NCT02873286|BG004|Baseline|Group 5 - Placebo|First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
11285348|NCT02873286|BG005|Baseline|Total|Total of all reporting groups
11285349|NCT02873286|FG000|Participant Flow|Group 1 - Single Low Dose / Booster|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285350|NCT02873286|FG001|Participant Flow|Group 2 - Two Low Doses|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285351|NCT02873286|FG002|Participant Flow|Group 3 - Single High Dose / Booster|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285352|NCT02873286|FG003|Participant Flow|Group 4 - Two High Doses|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285353|NCT02873286|FG004|Participant Flow|Group 5 - Placebo|First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
11285354|NCT02873286|OG000|Outcome|Group 1 - Single Low Dose / Booster|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285355|NCT02873286|OG001|Outcome|Group 2 - Two Low Doses|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285356|NCT02873286|OG002|Outcome|Group 3 - Single High Dose / Booster|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285357|NCT02873286|OG003|Outcome|Group 4 - Two High Doses|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285358|NCT02873286|OG004|Outcome|Group 5 - Placebo|First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
11285359|NCT02873286|EG000|Reported Event|Group 1 - Single Low Dose / Booster|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285360|NCT02873286|EG001|Reported Event|Group 2 - Two Low Doses|First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
11285361|NCT02873286|EG002|Reported Event|Group 3 - Single High Dose / Booster|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285362|NCT02873286|EG003|Reported Event|Group 4 - Two High Doses|First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
11285363|NCT02873286|EG004|Reported Event|Group 5 - Placebo|First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
11285364|NCT02873338|BG000|Baseline|Control (Idarubicin+Cytarabine)|"Induction:~Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)~Consolidation:~• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285365|NCT02873338|BG001|Baseline|Dociparstat 0.125 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)"
11285366|NCT02873338|BG002|Baseline|Dociparstat 0.25 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285367|NCT02873338|BG003|Baseline|Total|Total of all reporting groups
11285368|NCT02873338|FG000|Participant Flow|Control (Idarubicin+Cytarabine)|"Induction:~Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)~Consolidation:~• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285369|NCT02873338|FG001|Participant Flow|Dociparstat 0.125 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)"
11285370|NCT02873338|FG002|Participant Flow|Dociparstat 0.25 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285371|NCT02873338|OG000|Outcome|Control (Idarubicin+Cytarabine)|"Induction:~Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)~Consolidation:~• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285372|NCT02873338|OG001|Outcome|Dociparstat 0.125 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)"
11337706|NCT03591406|FG000|Participant Flow|Ferric Carboxymaltose (FCM)|"Participants treated with FCM given by IV injection or drip infusion~Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection~Strength: 10 mL vials containing 500 mg iron per vial~Dosage: 500mg/week or 1000mg/week (based on subject Body Weight (BW) and Hb value at screening)~Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline)~Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15."
11285373|NCT02873338|OG002|Outcome|Dociparstat 0.25 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285374|NCT02873338|EG000|Reported Event|Control (Idarubicin+Cytarabine)|"Induction:~Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)~Consolidation:~• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285375|NCT02873338|EG001|Reported Event|Dociparstat 0.125 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)"
11285376|NCT02873338|EG002|Reported Event|Dociparstat 0.25 mg/kg|"Induction:~Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)~Reinduction:~Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)~Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)~Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)~Consolidation:~Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)~Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)"
11285377|NCT02873377|BG000|Baseline|Enhanced Care|"Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the Enhanced Care intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call"
11285378|NCT02873377|BG001|Baseline|Standard Care|"Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The Standard Care group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline"
11285379|NCT02873377|BG002|Baseline|Total|Total of all reporting groups
11285380|NCT02873377|FG000|Participant Flow|Enhanced Care|"Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the Enhanced Care intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call"
11285381|NCT02873377|FG001|Participant Flow|Standard Care|"Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The Standard Care group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline"
11285382|NCT02873377|OG000|Outcome|Enhanced Care|"Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the Enhanced Care intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call"
11285383|NCT02873377|OG001|Outcome|Standard Care|"Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The Standard Care group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline"
11285384|NCT02873377|OG000|Outcome|All Workers Available - Before Randomization|All workers on constructions screened for eligibility
11285385|NCT02873377|EG000|Reported Event|Enhanced Care|"Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the Enhanced Care intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline~Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call"
11285386|NCT02873377|EG001|Reported Event|Standard Care|"Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The Standard Care group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.~Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)~Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)~Smoking Quitline Referral: Fax referral to the State smoking Quitline"
11285387|NCT02873429|BG000|Baseline|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
11285388|NCT02873429|BG001|Baseline|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
11285389|NCT02873429|BG002|Baseline|Total|Total of all reporting groups
11285390|NCT02873429|FG000|Participant Flow|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
11285391|NCT02873429|FG001|Participant Flow|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
11285392|NCT02873429|OG000|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
11285393|NCT02873429|OG001|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
11285394|NCT02873429|EG000|Reported Event|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
11285395|NCT02873429|EG001|Reported Event|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
11285396|NCT02873481|BG000|Baseline|Yoga (CPC+Y)|"Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)~Centering Pregnancy Care plus Yoga (CPC+Y): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session"
11285397|NCT02873481|BG001|Baseline|Comparison (CPC Alone)|To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.
11285398|NCT02873481|BG002|Baseline|Total|Total of all reporting groups
11285399|NCT02873481|FG000|Participant Flow|Yoga (CPC+Y)|"Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)~Centering Pregnancy Care plus Yoga (CPC+Y): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session"
11285400|NCT02873481|FG001|Participant Flow|Comparison (CPC Alone)|To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.
11285401|NCT02873481|OG000|Outcome|Yoga (CPC+Y)|"Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)~Centering Pregnancy Care plus Yoga (CPC+Y): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session"
11285402|NCT02873481|OG001|Outcome|Comparison (CPC Alone)|To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.
11285403|NCT02873481|EG000|Reported Event|Yoga (CPC+Y)|"Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)~Centering Pregnancy Care plus Yoga (CPC+Y): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session"
11285404|NCT02873481|EG001|Reported Event|Comparison (CPC Alone)|To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.
11285405|NCT02873585|BG000|Baseline|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit~Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography"
11285406|NCT02873585|FG000|Participant Flow|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit~Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography"
11285407|NCT02873585|OG000|Outcome|Standard Conventional Bitewing Radiography|Bitewing radiographs using a standard two-dimensional bitewing radiography
11285408|NCT02873585|OG001|Outcome|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography.~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit"
11285409|NCT02873585|OG001|Outcome|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit~Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography"
11285410|NCT02873585|OG000|Outcome|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit~Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography"
11285411|NCT02873585|EG000|Reported Event|Standard Conventional Bitewing Radiography|Bitewing radiographs using a standard two-dimensional bitewing radiography
11285412|NCT02873585|EG001|Reported Event|Stationary Intraoral Tomosynthesis|"Stationary intraoral tomosynthesis after standard conventional bitewing radiography~Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit~Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography"
11285413|NCT02873689|BG000|Baseline|Placebo|Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
11285414|NCT02873689|BG001|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
11285415|NCT02873689|BG002|Baseline|Total|Total of all reporting groups
11285416|NCT02873689|FG000|Participant Flow|Placebo|Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
11285417|NCT02873689|FG001|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
11285418|NCT02873689|OG000|Outcome|Placebo|Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
11285419|NCT02873689|OG001|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
11285420|NCT02873689|EG000|Reported Event|Placebo|Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
11285421|NCT02873689|EG001|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
11285422|NCT02873702|BG000|Baseline|Healing Period: Lansoprazole 30 mg|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285423|NCT02873702|BG001|Baseline|Healing Period: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285424|NCT02873702|BG002|Baseline|Total|Total of all reporting groups
11285425|NCT02873702|FG000|Participant Flow|Healing Period: Lansoprazole 30 mg|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285426|NCT02873702|FG001|Participant Flow|Healing Period: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285427|NCT02873702|FG002|Participant Flow|Maintenance Period: Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285428|NCT02873702|FG003|Participant Flow|Maintenance Period: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285429|NCT02873702|OG000|Outcome|Healing Period: Lansoprazole 30 mg|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285430|NCT02873702|OG001|Outcome|Healing Period: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285431|NCT02873702|OG000|Outcome|Maintenance Period: Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285432|NCT02873702|OG001|Outcome|Maintenance Period: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285433|NCT02873702|EG000|Reported Event|Healing Period: Lansoprazole 30 mg|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285434|NCT02873702|EG001|Reported Event|Healing Period: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
11285435|NCT02873702|EG002|Reported Event|Maintenance Period: Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285436|NCT02873702|EG003|Reported Event|Maintenance Period: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period.
11285437|NCT02873754|BG000|Baseline|STEP UP|"STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone.~Cognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest activity."
11285438|NCT02873754|FG000|Participant Flow|STEP UP|"STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone.~Cognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggested activity."
11285439|NCT02873754|OG000|Outcome|STEP UP|"STEP UP combines the following:~Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.~Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.~Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).~Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.~Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."
11285440|NCT02873754|EG000|Reported Event|STEP UP|"STEP UP combines the following:~Cognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.~Mobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.~Bupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).~Transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.~Nicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."
11285441|NCT02873923|BG000|Baseline|Patients With a Metastatic Soft Tissue Sarcoma|All patients included in eligible clinical trials of the meta-analysis
11285442|NCT02873923|FG000|Participant Flow|Patients With a Metastatic Soft Tissue Sarcoma|All patients included in eligible clinical trials of the meta-analysis
11285443|NCT02873923|OG000|Outcome|Patients With a Metastatic Soft Tissue Sarcoma|All patients included in eligible clinical trials of the meta-analysis
11285444|NCT02873923|EG000|Reported Event|Patients With a Metastatic Soft Tissue Sarcoma|All patients included in eligible clinical trials of the meta-analysis
11285445|NCT02873936|BG000|Baseline|Filgotinib 200 mg|Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
11285446|NCT02873936|BG001|Baseline|Filgotinib 100 mg|Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285447|NCT02873936|BG002|Baseline|Placebo|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285448|NCT02873936|BG003|Baseline|Total|Total of all reporting groups
11285449|NCT02873936|FG000|Participant Flow|Filgotinib 200 mg|Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
11285450|NCT02873936|FG001|Participant Flow|Filgotinib 100 mg|Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285451|NCT02873936|FG002|Participant Flow|Placebo|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285452|NCT02873936|OG000|Outcome|Filgotinib 200 mg|Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
11285453|NCT02873936|OG001|Outcome|Filgotinib 100 mg|Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285454|NCT02873936|OG002|Outcome|Placebo|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285455|NCT02873936|EG000|Reported Event|Filgotinib 200 mg|Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
11285456|NCT02873936|EG001|Reported Event|Filgotinib 100 mg|Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285457|NCT02873936|EG002|Reported Event|Placebo|Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
11285458|NCT02874066|BG000|Baseline|PTV/r/OBV/DSV|"Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks~PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks"
11285459|NCT02874066|FG000|Participant Flow|PTV/r/OBV/DSV|"Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks~PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks"
11285460|NCT02874066|OG000|Outcome|PTV/r/OBV/DSV|"Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks~PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks"
11285461|NCT02874066|EG000|Reported Event|PTV/r/OBV/DSV|"Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks~PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks"
11285462|NCT02874092|BG000|Baseline|Rheumatoid Arthritis|"-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks~Ticagrelor~MTX therapy"
11285463|NCT02874092|BG001|Baseline|Osteoarthritis|"-Diagnosis of osteoarthritis made by physician.~MTX therapy"
11285464|NCT02874092|BG002|Baseline|Total|Total of all reporting groups
11285465|NCT02874092|FG000|Participant Flow|Rheumatoid Arthritis|"-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks~Ticagrelor~MTX therapy"
11285466|NCT02874092|FG001|Participant Flow|Osteoarthritis|"-Diagnosis of osteoarthritis made by physician.~MTX therapy"
11285467|NCT02874092|OG000|Outcome|Rheumatoid Arthritis|"-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks~Ticagrelor~MTX therapy"
11285468|NCT02874092|EG000|Reported Event|Rheumatoid Arthritis|"-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks~Ticagrelor~MTX therapy"
11285469|NCT02874092|EG001|Reported Event|Osteoarthritis|"-Diagnosis of osteoarthritis made by physician.~MTX therapy"
11285470|NCT02874404|BG000|Baseline|All Subjects|Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11285471|NCT02874404|FG000|Participant Flow|All Subjects|Patients receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11285472|NCT02874404|OG000|Outcome|All Subjects|Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11285473|NCT02874404|OG000|Outcome|All Patients|Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11092471|NCT01540071|EG000|Reported Event|NRX 194204|"This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.~NRX 194204: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day"
11285474|NCT02874404|EG000|Reported Event|All Patients|Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
11285475|NCT02874534|BG000|Baseline|Behavioral Activation|"Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.~Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions."
11285476|NCT02874534|BG001|Baseline|Mindfulness Treatment|"BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.~Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions."
11285477|NCT02874534|BG002|Baseline|Total|Total of all reporting groups
11285478|NCT02874534|FG000|Participant Flow|Behavioral Activation|"Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.~Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions."
11337708|NCT03591406|OG000|Outcome|Ferric Carboxymaltose (FCM)|"Participants treated with FCM given by IV injection or drip infusion~Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection~Strength: 10 mL vials containing 500 mg iron per vial~Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening)~Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline)~Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15."
11285479|NCT02874534|FG001|Participant Flow|Mindfulness Treatment|"Behavioral Activation Treatment for Anhedonia (BATA) will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.~Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions."
11285480|NCT02874534|OG000|Outcome|Behavioral Activation|"Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.~Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions."
11285481|NCT02874534|OG001|Outcome|Mindfulness Treatment|"BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.~Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions."
11285482|NCT02874534|EG000|Reported Event|Behavioral Activation|"Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.~Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions."
11285483|NCT02874534|EG001|Reported Event|Mindfulness Treatment|"BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.~Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions."
11285484|NCT02874794|BG000|Baseline|Enalapril (Double-Blind Phase)|minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).
11285485|NCT02874794|BG001|Baseline|Sacubitril/Valsartan (Double-Blind Phase)|minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).
11285486|NCT02874794|BG002|Baseline|Total|Total of all reporting groups
11285487|NCT02874794|FG000|Participant Flow|Enalapril (Double-Blind Phase)|minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).
11285488|NCT02874794|FG001|Participant Flow|Sacubitril/Valsartan (Double-Blind Phase)|minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).
11285489|NCT02874794|OG000|Outcome|Enalapril (Double-Blind Phase)|minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).
11285490|NCT02874794|OG001|Outcome|Sacubitril/Valsartan (Double-Blind Phase)|minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).
11285491|NCT02874794|OG000|Outcome|Sacubitril/Valsartan (Double-Blind Phase)|minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).
11285492|NCT02874794|OG001|Outcome|Enalapril (Double-Blind Phase)|minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).
11285493|NCT02874794|EG000|Reported Event|Double Blind Phase Enalapril|Minimum dose: 2.5mg, BID, oral, tablet. Maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).
11285494|NCT02874794|EG001|Reported Event|Double Blind Phase Sacubitril/Valsartan|"Minimum dose: 24/26mg, BID, oral, tablet. Maximum dose:~97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg)."
11285495|NCT02874794|EG002|Reported Event|Open-Label Phase Sacubitril/Valsartan|LCZ696 tablets were provided for the 12-week open label extension.
11285496|NCT02874846|BG000|Baseline|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye daily (OU) in the evening (PM)
11285497|NCT02874846|BG001|Baseline|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye daily (OU) in the evening
11285498|NCT02874846|BG002|Baseline|Total|Total of all reporting groups
11285499|NCT02874846|FG000|Participant Flow|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
11285500|NCT02874846|FG001|Participant Flow|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
11285501|NCT02874846|OG000|Outcome|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
11285502|NCT02874846|OG001|Outcome|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening
11285503|NCT02874846|OG001|Outcome|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
11285504|NCT02874846|EG000|Reported Event|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye (OU) daily in the evening (PM)
11285505|NCT02874846|EG001|Reported Event|Netarsudil Ophthalmic Solution Vehicle|1 drop in each eye (OU) daily in the evening (PM)
11285506|NCT02874924|BG000|Baseline|Rapamycin|"Rapamycin 1mg taken once daily for 8 weeks~Rapamycin: treatment"
11285507|NCT02874924|BG001|Baseline|Placebo|"Placebo taken once daily for 8 weeks~Placebo: control"
11285508|NCT02874924|BG002|Baseline|Rapamycin Alone - Cardiovascular Effects|"No placebo control; Rapamycin 1mg once daily for 8 weeks~Rapamycin: No placebo control in this substudy group"
11285509|NCT02874924|BG003|Baseline|Total|Total of all reporting groups
11285510|NCT02874924|FG000|Participant Flow|Rapamycin|"Rapamycin 1mg taken once daily for 8 weeks~Rapamycin: treatment"
11285511|NCT02874924|FG001|Participant Flow|Placebo|"Placebo taken once daily for 8 weeks~Placebo: control"
11285512|NCT02874924|FG002|Participant Flow|Rapamycin Alone - Cardiovascular Effects|"No placebo control; Rapamycin 1mg once daily for 8 weeks~Rapamycin: No placebo control in this substudy group"
11285513|NCT02874924|OG000|Outcome|Rapamycin|"Rapamycin 1mg taken once daily for 8 weeks~Rapamycin: treatment"
11285514|NCT02874924|OG001|Outcome|Placebo|"Placebo taken once daily for 8 weeks~Placebo: control"
11285515|NCT02874924|OG002|Outcome|Rapamycin Alone - Cardiovascular Effects|"No placebo control; Rapamycin 1mg once daily for 8 weeks~Rapamycin: No placebo control in this substudy group"
11285516|NCT02874924|EG000|Reported Event|Rapamycin|"Rapamycin 1mg taken once daily for 8 weeks~Rapamycin: treatment"
11285517|NCT02874924|EG001|Reported Event|Placebo|"Placebo taken once daily for 8 weeks~Placebo: control"
11285518|NCT02874924|EG002|Reported Event|Rapamycin Alone - Cardiovascular Effects|"No placebo control; Rapamycin 1mg once daily for 8 weeks~Rapamycin: No placebo control in this substudy group"
11285519|NCT02875028|BG000|Baseline|Vorapaxar|"subjects will be treated with 4x2,5mg vorapaxar in empty lactose-starch capsules~Vorapaxar: 10mg-20mg vorapaxar to achieve >80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition~LPS: 2ng/kg Lipopolysaccharide as a bolus infusion"
11285520|NCT02875028|BG001|Baseline|Placebo|"subjects will be treated with 4 empty lactose-starch capsules~Placebo~LPS: 2ng/kg Lipopolysaccharide as a bolus infusion"
11285521|NCT02875028|BG002|Baseline|Total|Total of all reporting groups
11285522|NCT02875028|FG000|Participant Flow|Vorapaxar, Then Placebo|Subjects randomized to this group received vorapaxar treatment first (10-20mg) plus 2ng/kg bodyweight lipopolysaccharide (LPS) bolus infusion and after a washout period of at least 8 weeks, the placebo treatment (0.9% sodium chloride infusion) plus 2ng/kg bodyweight LPS bolus infusion.
11285523|NCT02875028|FG001|Participant Flow|Placebo First, Then Vorapaxar|Subjects randomized to this group received the placebo treatment (0.9% sodium chloride infusion) plus 2ng/kg bodyweight LPS bolus infusion first, and after a washout period of at least 8 weeks, vorapaxar treatment (10-20mg) plus a 2ng/kg bodyweight LPS bolus infusion.
11285524|NCT02875028|OG000|Outcome|Vorapaxar|Intervention: 10(-20)mg vorapaxar and 2ng/kg bodyweight LPS bolus infusion
11285525|NCT02875028|OG001|Outcome|Placebo|Intervention: placebo tablet intake (lactose starch) and 2ng/kg bodyweight LPS bolus infusion
11285526|NCT02875028|OG000|Outcome|Vorapaxar|Intervention: 10(-20mg) vorapaxar and 2ng/kg bodyweight LPS bolus infusion
11285527|NCT02875028|OG001|Outcome|Placebo|Intervention: placebo tablets and 2ng/kg bodyweight LPS bolus infusion
11285528|NCT02875028|EG000|Reported Event|Vorapaxar|"subjects will be treated with 4x2,5mg vorapaxar in empty lactose-starch capsules~Vorapaxar: 10mg-20mg vorapaxar to achieve >80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition~LPS: 2ng/kg Lipopolysaccharide as a bolus infusion"
11285529|NCT02875028|EG001|Reported Event|Placebo|"subjects will be treated with 4 empty lactose-starch capsules~Placebo~LPS: 2ng/kg Lipopolysaccharide as a bolus infusion"
11285530|NCT02875080|BG000|Baseline|Sequence 1|Subjects randomized to Sequence 1 received an ODT without water on Day 1, a conventional tablet on Day 21, and an ODT with water on Day 41.
11285531|NCT02875080|BG001|Baseline|Sequence 2|Subjects randomized to Sequence 2 received an ODT with water on Day 1, an ODT without water on Day 21, and a conventional tablet on Day 41.
11285532|NCT02875080|BG002|Baseline|Sequence 3|Subjects randomized to Sequence 3 received a conventional tablet on Day 1, an ODT with water on Day 21, and an ODT without water on Day 41.
11285533|NCT02875080|BG003|Baseline|Total|Total of all reporting groups
11285534|NCT02875080|FG000|Participant Flow|Sequence 1|Subjects randomized to Sequence 1 received an ODT without water on Day 1, a conventional tablet on Day 21, and an ODT with water on Day 41.
11285535|NCT02875080|FG001|Participant Flow|Sequence 2|Subjects randomized to Sequence 2 received an ODT with water on Day 1, an ODT without water on Day 21, and a conventional tablet on Day 41.
11285536|NCT02875080|FG002|Participant Flow|Sequence 3|Subjects randomized to Sequence 3 received a conventional tablet on Day 1, an ODT with water on Day 21, and an ODT without water on Day 41.
11285537|NCT02875080|OG000|Outcome|OPC-34712 Disintegrating Tablet With Water|OPC-34712 (4 mg) orally disintegrating tablet is administered with water.
11285538|NCT02875080|OG001|Outcome|OPC-34712 Disintegrating Tablet Without Water|OPC-34712 (4 mg) orally disintegrating tablet is administered without water.
11285539|NCT02875080|OG002|Outcome|OPC-34712 Conventional Tablet With Water|OPC-34712 (4 mg) conventional tablet is administered with water.
11285540|NCT02875080|EG000|Reported Event|OPC-34712 Disintegrating Tablet With Water|OPC-34712 (4 mg) orally disintegrating tablet is administered with water.
11285541|NCT02875080|EG001|Reported Event|OPC-34712 Disintegrating Tablet Without Water|OPC-34712 (4 mg) orally disintegrating tablet is administered without water.
11285542|NCT02875080|EG002|Reported Event|OPC-34712 Conventional Tablet With Water|OPC-34712 (4 mg) conventional tablet is administered with water.
11285543|NCT02875340|BG000|Baseline|VAL401 Treatment|Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)
11285544|NCT02875340|FG000|Participant Flow|VAL401 Treatment|Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)
11285545|NCT02875340|OG000|Outcome|VAL401 Treatment - Intention to Treat Group|"Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg).~This group includes all patients who completed screening, but excludes the one patient for whom the date of diagnosis is inconsistent."
11285546|NCT02875340|OG001|Outcome|VAL401 Treatment - Per Protocol Group|"Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg).~This groups excludes the 2 patients received treatment for less than 10 days, as well as the patient for whom the date of diagnosis is inconsistent."
11285547|NCT02875340|OG000|Outcome|VAL401 Treatment|Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)
11285548|NCT02875340|OG000|Outcome|VAL401 Treatment - Day 1|Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)
11285549|NCT02875340|OG001|Outcome|VAL401 Treatment - Day 15 (2 mg)|Pharmacokinetic measurements taken on Day 15 of dosing on 2 mg daily dose level
11285550|NCT02875340|OG002|Outcome|VAL401 Treatment - Day 15 (6 mg)|Pharmacokinetic measurements taken on Day 15 of dosing on 6 mg daily dose level
11285551|NCT02875340|OG003|Outcome|VAL401 Treatment - Day 15 (8 mg)|Pharmacokinetic measurements taken on Day 15 of dosing on 8 mg daily dose level
11285552|NCT02875340|EG000|Reported Event|VAL401 Treatment|Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)
11285553|NCT02875366|BG000|Baseline|Placebo|Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.
11285554|NCT02875366|BG001|Baseline|LUM/IVA|Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
11285555|NCT02875366|BG002|Baseline|Total|Total of all reporting groups
11285556|NCT02875366|FG000|Participant Flow|Placebo|Participants received placebo matched to lumacaftor (LUM)/ivacaftor (IVA) fixed-dose combination tablet orally every 12 hours (q12h) for 24 weeks.
11285557|NCT02875366|FG001|Participant Flow|LUM/IVA|Participants received LUM 400 milligram (mg)/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
11285558|NCT02875366|OG000|Outcome|Placebo|Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.
11092472|NCT01540162|BG000|Baseline|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
11092473|NCT01540162|BG001|Baseline|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
11285559|NCT02875366|OG001|Outcome|LUM/IVA|Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
11285560|NCT02875366|EG000|Reported Event|Placebo|Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.
11285561|NCT02875366|EG001|Reported Event|LUM/IVA|Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
11285562|NCT02875392|BG000|Baseline|Fucoidan Use|"FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)~275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules."
11285563|NCT02875392|BG001|Baseline|Placebo Pills|"placebo capsule 6 per day (before breakfast and supper)~placebo pills: taking placebo pills as if patients are under treatment."
11285564|NCT02875392|BG002|Baseline|Total|Total of all reporting groups
11285565|NCT02875392|FG000|Participant Flow|Fucoidan Use|"FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)~275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules."
11285566|NCT02875392|FG001|Participant Flow|Placebo Pills|"placebo capsule 6 per day (before breakfast and supper)~placebo pills: taking placebo pills as if patients are under treatment."
11285567|NCT02875392|OG000|Outcome|Fucoidan Use|"FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)~275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules."
11285568|NCT02875392|OG001|Outcome|Placebo Pills|"placebo capsule 6 per day (before breakfast and supper)~placebo pills: taking placebo pills as if patients are under treatment."
11285569|NCT02875392|EG000|Reported Event|Fucoidan Use|"FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)~275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules."
11285570|NCT02875392|EG001|Reported Event|Placebo Pills|"placebo capsule 6 per day (before breakfast and supper)~placebo pills: taking placebo pills as if patients are under treatment."
11285571|NCT02875613|BG000|Baseline|Avelumab|"Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle~Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal."
11285572|NCT02875613|FG000|Participant Flow|Avelumab|"Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle~Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal."
11285573|NCT02875613|OG000|Outcome|Avelumab|"Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle~Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal."
11092474|NCT01540162|BG002|Baseline|Total|Total of all reporting groups
11285574|NCT02875613|EG000|Reported Event|Avelumab|"Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle~Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal."
11285575|NCT02875834|BG000|Baseline|Sodium Zirconium Cyclosilicate (ZS) 10g Tid|Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.
11285576|NCT02875834|BG001|Baseline|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
11285577|NCT02875834|BG002|Baseline|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
11285578|NCT02875834|BG003|Baseline|Placebo|Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
11285579|NCT02875834|BG004|Baseline|Total|Total of all reporting groups
11285580|NCT02875834|FG000|Participant Flow|Sodium Zirconium Cyclosilicate (ZS) 10g Tid|Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.
11285581|NCT02875834|FG001|Participant Flow|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
11285582|NCT02875834|FG002|Participant Flow|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
11285583|NCT02875834|FG003|Participant Flow|Placebo|Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
11285584|NCT02875834|OG000|Outcome|Sodium Zirconium Cyclosilicate (ZS) 10g Tid|Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.
11285585|NCT02875834|OG001|Outcome|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
11285586|NCT02875834|OG002|Outcome|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
11285587|NCT02875834|OG003|Outcome|Placebo|Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
11285588|NCT02875834|EG000|Reported Event|Sodium Zirconium Cyclosilicate (ZS) 10g Tid|Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.
11285589|NCT02875834|EG001|Reported Event|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
11285590|NCT02875834|EG002|Reported Event|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
11285591|NCT02875834|EG003|Reported Event|Placebo|Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
11285592|NCT02875977|BG000|Baseline|Experimental Counseling|Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.
11285593|NCT02875977|BG001|Baseline|Standard Counseling|Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
11285594|NCT02875977|BG002|Baseline|Total|Total of all reporting groups
11285595|NCT02875977|FG000|Participant Flow|Experimental Counseling|Patients randomized to this arm receive experimental counseling on the importance of attending pelvic floor physical therapy (PFPT) appointments. This includes the standard 2-page educational handout and a 4-minute educational video.
11285596|NCT02875977|FG001|Participant Flow|Standard Counseling|Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
11285597|NCT02875977|OG000|Outcome|Experimental Counseling|Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.
11285598|NCT02875977|OG001|Outcome|Standard Counseling|Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
11285599|NCT02875977|EG000|Reported Event|Experimental Counseling|Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.
11285600|NCT02875977|EG001|Reported Event|Standard Counseling|Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
11287188|NCT02899195|BG000|Baseline|Concurrent Durvalumab Then Maintenance Durvalumab|"Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion.~Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration.~After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment.~Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes."
11285601|NCT02876055|BG000|Baseline|Single Shot Interscalene Nerve Block|"An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.~Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block"
11285602|NCT02876055|BG001|Baseline|Continuous Interscalene Nerve Block|"An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.~Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.~Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block"
11285603|NCT02876055|BG002|Baseline|Local Infiltration Analgesia (LIA)|"The LIA group will utilize weight based dosing of Ropivacaine as part of a cocktail solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.~Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery"
11285604|NCT02876055|BG003|Baseline|Total|Total of all reporting groups
11285605|NCT02876055|FG000|Participant Flow|Single Shot Interscalene Nerve Block|"An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.~Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block"
11285606|NCT02876055|FG001|Participant Flow|Continuous Interscalene Nerve Block|"An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.~Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.~Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block"
11285607|NCT02876055|FG002|Participant Flow|Local Infiltration Analgesia (LIA)|"The LIA group will utilize weight based dosing of Ropivacaine as part of a cocktail solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.~Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery"
11285608|NCT02876055|OG000|Outcome|Single Shot Interscalene Nerve Block|"An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.~Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block"
11285609|NCT02876055|OG001|Outcome|Continuous Interscalene Nerve Block|"An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.~Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.~Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block"
11285610|NCT02876055|OG002|Outcome|Local Infiltration Analgesia (LIA)|"The LIA group will utilize weight based dosing of Ropivacaine as part of a cocktail solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.~Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery"
11285611|NCT02876055|EG000|Reported Event|Single Shot Interscalene Nerve Block|"An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.~Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block"
11092475|NCT01540162|FG000|Participant Flow|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
11092476|NCT01540162|FG001|Participant Flow|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
11092477|NCT01540162|OG000|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
11092478|NCT01540162|OG001|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
11285612|NCT02876055|EG001|Reported Event|Continuous Interscalene Nerve Block|"An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.~Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.~Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block"
11285613|NCT02876055|EG002|Reported Event|Local Infiltration Analgesia (LIA)|"The LIA group will utilize weight based dosing of Ropivacaine as part of a cocktail solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.~Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery"
11285614|NCT02876159|BG000|Baseline|Vaccination Naïve|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285615|NCT02876159|BG001|Baseline|Vaccination Experienced|"Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285616|NCT02876159|BG002|Baseline|Total|Total of all reporting groups
11285617|NCT02876159|FG000|Participant Flow|Vaccination Naïve|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285618|NCT02876159|FG001|Participant Flow|Vaccination Experienced|"Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285619|NCT02876159|OG000|Outcome|Vaccination Naïve|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285620|NCT02876159|OG001|Outcome|Vaccination Experienced|"Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285621|NCT02876159|OG000|Outcome|Vaccination Naïve|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285622|NCT02876159|OG001|Outcome|Vaccination Experienced|"Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285623|NCT02876159|OG000|Outcome|Vaccination Naive|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285624|NCT02876159|EG000|Reported Event|Vaccination Naïve|"Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285625|NCT02876159|EG001|Reported Event|Vaccination Experienced|"Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.~2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose."
11285626|NCT02876575|BG000|Baseline|BiZact Arm|48 adults undergoing tonsillectomy
11285627|NCT02876575|FG000|Participant Flow|BiZact Arm|A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
11285628|NCT02876575|OG000|Outcome|BiZact Arm|A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
11285629|NCT02876575|OG000|Outcome|BiZact Arm|A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger
11285630|NCT02876575|EG000|Reported Event|BiZact Arm|48 adults undergoing tonsillectomy
11285631|NCT02876601|BG000|Baseline|LPS+ First Defibrotide, Then Placebo|"First Intervention:~LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion~Washout for 6 weeks:~Second Intervention:~LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion"
11285632|NCT02876601|BG001|Baseline|LPS+ First Placebo, Then Defibrotide|"First Intervention:~LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion~Washout for 6 weeks:~Second Intervention:~LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion"
11285633|NCT02876601|BG002|Baseline|Placebo+ First Defibrotide, Then Placebo|"4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~First Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours~Washout: 6 weeks~Second Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h"
11285634|NCT02876601|BG003|Baseline|Placebo+ First Placebo, Then Defibrotide|"4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~First Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h~Washout: 6 weeks~Second Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours"
11285635|NCT02876601|BG004|Baseline|Total|Total of all reporting groups
11285636|NCT02876601|FG000|Participant Flow|LPS+ First Defibrotide, Then Placebo|"First Intervention:~LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion~Washout for 6 weeks:~Second Intervention:~LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion"
11285637|NCT02876601|FG001|Participant Flow|LPS+ First Placebo, Then Defibrotide|"First Intervention:~LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion~Washout for 6 weeks:~Second Intervention:~LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion"
11285638|NCT02876601|FG002|Participant Flow|Placebo+ First Defibrotide, Then Placebo|"4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~First Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours~Washout: 6 weeks~Second Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h"
11285639|NCT02876601|FG003|Participant Flow|Placebo+ First Placebo, Then Defibrotide|"4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo.~First Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h~Washout: 6 weeks~Second Intervention:~Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours"
11285640|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus 2ng/kg bodyweight LPS bolus infusion
11285641|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: 6.25mg/kg bodyweight defibrotide plus 2ng/kg bodyweight LPS bolus infusion
11285642|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: placebo infusion (0.9% sodium chloride) plus 2ng/kg bodyweight LPS bolus infusion
11285643|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo (0.9% sodium chloride) infusion placebo bolus infusion (0.9% sodium chloride)
11285644|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: placebo infusion (0.9% sodium chloride) plus 2ng/kg bodyweight LPS bolus infusion
11092479|NCT01540162|EG000|Reported Event|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
11092480|NCT01540162|EG001|Reported Event|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
11285645|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus placebo bolus infusion (0.9%sodium chloride)
11285646|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo infusion (0.9% sodium chloride) plus placebo bolus infusion (0.9% sodium chloride)
11285647|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide and 2ng/kg bodyweight LPS bolus
11285648|NCT02876601|OG001|Outcome|LPS/Placebo|Intervention: placebo infusion (0.9% sodium chloride) and 2ng/kg bodyweight LPS bolus
11285649|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide and Placebo bolus (0.9% sodium chloride)
11285650|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo infusion (0.9% sodium chloride) and placebo bolus infusion (0.9% sodium chloride)
11285651|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus 2ng/kg lipopolysaccharide bolus infusion
11285652|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: 6.25mg/kg bodyweight defibrotide plus placebo bolus infusion (0.9% sodium chloride)
11285653|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus Placebo infusion (0.9% sodium chloride
11285654|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus 2ng/kg bodyweight lipopolysaccharide
11285655|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: Placebo infusion (0.9% sodium chloride) plus 2ng/kg bodyweight LPS
11285656|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: placebo bolus (0.9% sodium chloride) plus 6.25mg/kg bodyweight defibrotide
11285657|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo bolus (0.9% sodium chloride) plus placebo (0.9% sodium chloride) infusion
11285658|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus infusionbolus infusion of 2ng/kg bodyweight LPS
11285659|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: Bolus infusion of 2ng/kg bodyweight LPS plus Placebo (0.9% sodium chloride)
11285660|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight Defibrotide infusion plus Placebo (0.9% sodium chloride)
11285661|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: Placebo (0.9% sodium chloride) bolus infusion plus placebo (0.9% sodium chloride) infusion
11285662|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: Defibrotide 6.25mg/kg infusion plus bolus infusion of 2ng/kg bodyweight LPS
11285663|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: placebo (0.9% sodium chloride) infusion plus 2ng/kg bodyweight LPS bolus infusion
11285664|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide infusion plus placebo (0.9% sodium chloride) bolus infusion
11285665|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide infusion plus 2ng/kg LPS bolus infusion
11285666|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: placebo (0.9% sodium chloride) infusion plus 2ng/kg bodyweight LPS
11285667|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide plus placebo (0.9% sodium chloride) infusion
11285668|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo (0.9% sodium chloride) infusion plus placebo (0.9% sodium chloride) bolus infusion
11285669|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: Placebo infusion (0.9% sodium chloride) plus 2ng/kg bodyweight LPS bolus infusion
11285670|NCT02876601|OG002|Outcome|Placebo Plus Defibrotie|Intervention: 6.25mg/kg bodyweight defibrotide plus placebo bolus infusion (0.9% sodium chloride solution)
11285671|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: Placebo (0.9% sodium chloride solution) infusion plus placebo bolus infusion (0.9% sodium chloride)
11285672|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight LPS plus bolus infusion of 2ng/kg bodyweight LPS
11285673|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: placebo infusion (0.9% sodium chloride solution) plus bolus infusion of 2ng/kg bodyweight LPS
11285674|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight defibrotide infusion plus placebo (0.9% sodium chloride solution) bolus infusion
11285675|NCT02876601|OG003|Outcome|Placebo Plus Placebo|Intervention: placebo (0.9%sodium chloride solution) infusion plus placebo bolus infusion (0.9% sodium chloride solution)
11285676|NCT02876601|OG000|Outcome|LPS Plus Defibrotide|Intervention: 6.25mg/kg bodyweight infusion plus 2ng/kg bodyweight LPS bolus infusion
11285677|NCT02876601|OG001|Outcome|LPS Plus Placebo|Intervention: placebo infusion (0.9% sodium chloride infusion) plus 2ng/kg bodyweight LPS bolus infusion
11285678|NCT02876601|OG002|Outcome|Placebo Plus Defibrotide|Intervention: 6.25mg/kg bodyweight infusion plus placebo (0.9% sodium chloride solution) bolus infusion
11285679|NCT02876601|EG000|Reported Event|Defibrotide Plus LPS|Intervention: 6.25mg/kg bodyweight defibrotide infusion plus 2ng/kg bodyweight LPS infusion
11285680|NCT02876601|EG001|Reported Event|Placebo Plus LPS|Intervention: placebo infusion (0.9% sodium chloride solution) plus 2ng/kg bodyweight LPS infusion
11285681|NCT02876601|EG002|Reported Event|Defibrotide Plus Placebo|Intervention: 6.25mg/kg bodyweight defibrotide infusion plus placebo bolus infusion (0.9% sodium chloride solution)
11285682|NCT02876601|EG003|Reported Event|Placebo/Placebo|Intervention: placebo infusion (0.9% sodium chloride solution) plus placebo bolus infusion (0.9% sodium chloride solution)
11285683|NCT02876757|BG000|Baseline|5ARI Users|5ARI: Exposure to finasteride/dutasteride
11285684|NCT02876757|BG001|Baseline|Non 5ARI Users|Matched patients without 5ARI usage
11285685|NCT02876757|BG002|Baseline|Total|Total of all reporting groups
11285686|NCT02876757|FG000|Participant Flow|5ARI Users|5ARI: Exposure to finasteride/dutasteride
11285687|NCT02876757|FG001|Participant Flow|Non 5ARI Users|
11285688|NCT02876757|OG000|Outcome|5ARI Users|5ARI: Exposure to finasteride/dutasteride
11285689|NCT02876757|OG001|Outcome|Non 5ARI Users|
11285690|NCT02876757|EG000|Reported Event|5ARI Users|5ARI: Exposure to finasteride/dutasteride
11285691|NCT02876757|EG001|Reported Event|Non 5ARI Users|Matched control patients with no exposure to 5ARI
11285692|NCT02876887|BG000|Baseline|Cocoa|"Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.~Cocoa"
11285693|NCT02876887|BG001|Baseline|Placebo|"Three servings per day of placebo beverages for six months.~Placebo"
11285694|NCT02876887|BG002|Baseline|Total|Total of all reporting groups
11285695|NCT02876887|FG000|Participant Flow|Cocoa|"Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.~Cocoa"
11285696|NCT02876887|FG001|Participant Flow|Placebo|"Three servings per day of placebo beverages for six months.~Placebo"
11285697|NCT02876887|OG000|Outcome|Cocoa|"Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.~Cocoa"
11285698|NCT02876887|OG001|Outcome|Placebo|"Three servings per day of placebo beverages for six months.~Placebo"
11285699|NCT02876887|EG000|Reported Event|Cocoa|"Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.~Cocoa"
11285700|NCT02876887|EG001|Reported Event|Placebo|"Three servings per day of placebo beverages for six months.~Placebo"
11285701|NCT02876900|BG000|Baseline|Low Dose Asenapine Maleate Patch|"Low dose asenapine maleate, transdermal patches will be compared against placebo patches.~Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285702|NCT02876900|BG001|Baseline|High Dose Asenapine Maleate Patch|"High dose asenapine maleate, transdermal patches will be compared against placebo patches.~High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285703|NCT02876900|BG002|Baseline|Placebo Patch|Placebo transdermal patch
11285704|NCT02876900|BG003|Baseline|Total|Total of all reporting groups
11285705|NCT02876900|FG000|Participant Flow|Low Dose Asenapine Maleate Patch|"Low dose asenapine maleate, transdermal patches will be compared against placebo patches.~Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch.~Placebo: Evaluate Low Dose versus Placebo."
11285706|NCT02876900|FG001|Participant Flow|High Dose Asenapine Maleate Patch|"High dose asenapine maleate, transdermal patches will be compared against placebo patches.~High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch~Placebo: Evaluate High Dose versus Placebo."
11285707|NCT02876900|FG002|Participant Flow|Placebo Patch|Placebo transdermal patch
11285708|NCT02876900|OG000|Outcome|Low Dose Asenapine Maleate Patch|"Low dose asenapine maleate, transdermal patches will be compared against placebo patches.~Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285709|NCT02876900|OG001|Outcome|High Dose Asenapine Maleate Patch|"High dose asenapine maleate, transdermal patches will be compared against placebo patches.~High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285710|NCT02876900|OG002|Outcome|Placebo Patch|Placebo transdermal patch
11285711|NCT02876900|EG000|Reported Event|Low Dose Asenapine Maleate Patch|"Low dose asenapine maleate, transdermal patches will be compared against placebo patches.~Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285712|NCT02876900|EG001|Reported Event|High Dose Asenapine Maleate Patch|"High dose asenapine maleate, transdermal patches will be compared against placebo patches.~High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch~Placebo: The study will evaluate placebo transdermal patch."
11285713|NCT02876900|EG002|Reported Event|Placebo|Placebo transdermal patch
11285714|NCT02876926|BG000|Baseline|"Enhanced Home-based Testing"|"These participants will download a study-specific smartphone app (eTEST), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.~Smart home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring."
11285715|NCT02876926|BG001|Baseline|Home-based Testing Alone|"These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.~Home-based testing only: A standard home-based HIV test kit."
11285716|NCT02876926|BG002|Baseline|Reminders for Clinic-based Testing|"Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.~Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location"
11285717|NCT02876926|BG003|Baseline|Total|Total of all reporting groups
11285718|NCT02876926|FG000|Participant Flow|"Enhanced Home-based Testing"|"These participants will download a study-specific smartphone app (eTEST), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.~Smart home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring."
11285719|NCT02876926|FG001|Participant Flow|Home-based Testing Alone|"These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.~Home-based testing only: A standard home-based HIV test kit."
11285720|NCT02876926|FG002|Participant Flow|Reminders for Clinic-based Testing|"Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.~Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location"
11285721|NCT02876926|OG000|Outcome|"Enhanced Home-based Testing"|"These participants will download a study-specific smartphone app (eTEST), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.~Smart home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring."
11285722|NCT02876926|OG001|Outcome|Home-based Testing Alone|"These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.~Home-based testing only: A standard home-based HIV test kit."
11285723|NCT02876926|OG002|Outcome|Reminders for Clinic-based Testing|"Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.~Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location"
11285724|NCT02876926|EG000|Reported Event|"Enhanced Home-based Testing"|"These participants will download a study-specific smartphone app (eTEST), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.~Smart home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring."
11285725|NCT02876926|EG001|Reported Event|Home-based Testing Alone|"These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.~Home-based testing only: A standard home-based HIV test kit."
11285726|NCT02876926|EG002|Reported Event|Reminders for Clinic-based Testing|"Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.~Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location"
11285727|NCT02877004|BG000|Baseline|Laser for 4 Weeks|"3 Low-Level Laser Therapy Treatments Weekly~3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks"
11285728|NCT02877004|BG001|Baseline|Laser for 6 Weeks|"2 Low-Level Laser Therapy Treatments Weekly~2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks"
11285729|NCT02877004|BG002|Baseline|Laser for 12 Weeks|"1 Low-Level Laser Therapy Treatment Weekly~1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks"
11285730|NCT02877004|BG003|Baseline|Total|Total of all reporting groups
11285731|NCT02877004|FG000|Participant Flow|Laser for 4 Weeks|"3 Low-Level Laser Therapy Treatments Weekly~3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks"
11285732|NCT02877004|FG001|Participant Flow|Laser for 6 Weeks|"2 Low-Level Laser Therapy Treatments Weekly~2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks"
11285733|NCT02877004|FG002|Participant Flow|Laser for 12 Weeks|"1 Low-Level Laser Therapy Treatment Weekly~1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks"
11285734|NCT02877004|OG000|Outcome|Laser for 4 Weeks|"3 Low-Level Laser Therapy Treatments Weekly~3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks"
11285735|NCT02877004|OG001|Outcome|Laser for 6 Weeks|"2 Low-Level Laser Therapy Treatments Weekly~2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks"
11285736|NCT02877004|OG002|Outcome|Laser for 12 Weeks|"1 Low-Level Laser Therapy Treatment Weekly~1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks"
11285737|NCT02877004|EG000|Reported Event|Laser for 4 Weeks|"3 Low-Level Laser Therapy Treatments Weekly~3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks"
11285738|NCT02877004|EG001|Reported Event|Laser for 6 Weeks|"2 Low-Level Laser Therapy Treatments Weekly~2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks"
11285739|NCT02877004|EG002|Reported Event|Laser for 12 Weeks|"1 Low-Level Laser Therapy Treatment Weekly~1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks"
11285740|NCT02877082|BG000|Baseline|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor's discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
11285741|NCT02877082|FG000|Participant Flow|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor's discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
11285742|NCT02877082|OG000|Outcome|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor's discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
11285743|NCT02877082|EG000|Reported Event|Tacrolimus, Bortezomib, Thymoglobulin|"Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor's discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.~Thymoglobulin: Given IV~Bortezomib: Given IV~Tacrolimus: Given IV and PO"
11285744|NCT02877095|BG000|Baseline|In-patient Pilot Study|"All subjects in the in-patient pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285745|NCT02877095|BG001|Baseline|Out-patient Pilot Study|"All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285746|NCT02877095|BG002|Baseline|Total|Total of all reporting groups
11285747|NCT02877095|FG000|Participant Flow|In-patient Pilot|"All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285748|NCT02877095|FG001|Participant Flow|Out-patient Pilot Study|"All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285749|NCT02877095|OG000|Outcome|In-patient Pilot|"All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285750|NCT02877095|OG001|Outcome|Out-patient Pilot Study|"All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285751|NCT02877095|EG000|Reported Event|In-patient Pilot Study|"All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285752|NCT02877095|EG001|Reported Event|Out-patient Pilot Study|"All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.~Furosemide: subcutaneous furosemide delivered via subcutaneous pump"
11285753|NCT02877485|BG000|Baseline|Triamcinolone Acetonide Then Ayr Spray|"This study arm will start with 6 weeks of therapy with the intranasal steroid, followed by 6 weeks of therapy with a placebo, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285754|NCT02877485|BG001|Baseline|Ayr Spray Then Triamcinolone Acetonide|"This study arm will start with 6 weeks of placebo, followed by 6 weeks of therapy with the intranasal steroid, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285755|NCT02877485|BG002|Baseline|Total|Total of all reporting groups
11285756|NCT02877485|FG000|Participant Flow|Triamcinolone Acetonide Then Ayr Spray|"This study arm will start with 6 weeks of therapy with the intranasal steroid, followed by 6 weeks of therapy with a placebo, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285757|NCT02877485|FG001|Participant Flow|Ayr Spray Then Triamcinolone Acetonide|"This study arm will start with 6 weeks of placebo, followed by 6 weeks of therapy with the intranasal steroid, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285758|NCT02877485|OG000|Outcome|Triamcinolone Acetonide Then Ayr Spray|"This study arm will start with 6 weeks of therapy with the intranasal steroid, followed by 6 weeks of therapy with a placebo, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285759|NCT02877485|OG001|Outcome|Ayr Spray Then Triamcinolone Acetonide|"This study arm will start with 6 weeks of placebo, followed by 6 weeks of therapy with the intranasal steroid, with a two week washout period in between treatments.~Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.~Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days."
11285760|NCT02877485|OG000|Outcome|Surgery Patients|Participants who underwent surgery
11285761|NCT02877485|EG000|Reported Event|Triamcinolone Acetonide|Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.
11285762|NCT02877485|EG001|Reported Event|Ayr Spray|Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
11285763|NCT02877680|BG000|Baseline|Intervention|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors"
11285764|NCT02877680|BG001|Baseline|Usual Care|Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
11285765|NCT02877680|BG002|Baseline|Total|Total of all reporting groups
11285766|NCT02877680|FG000|Participant Flow|Intervention|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors."
11285767|NCT02877680|FG001|Participant Flow|Usual Care|Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
11285768|NCT02877680|OG000|Outcome|Adolescent-Parent Dyads|"Upon recruitment and enrollment, families completed baseline questionnaires. After baseline questionnaire completion, families were randomized 2:1 to (A) intervention group where parents use a strengths-based mobile health (mHealth) app, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors, or (B) usual diabetes care group, without use of app during the study period.~Both groups completed the same follow-up surveys. Additionally, intervention parents completed a set of follow-up questionnaires about usability of the app, and intervention families were asked to participate in an exit interview to share their experiences with the app."
11285769|NCT02877680|OG000|Outcome|Intervention|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors."
11285770|NCT02877680|OG000|Outcome|Intervention - Parent|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors."
11285771|NCT02877680|OG001|Outcome|Intervention - Adolescent|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors."
11285772|NCT02877680|OG000|Outcome|Intervention|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors"
11285773|NCT02877680|OG001|Outcome|Usual Care|Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
11285774|NCT02877680|EG000|Reported Event|Intervention|"Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.~T1Doing Well: Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors."
11285775|NCT02877680|EG001|Reported Event|Usual Care|Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
11285776|NCT02877927|BG000|Baseline|Omadacycline|Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets.
11285777|NCT02877927|BG001|Baseline|Linezolid|Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets.
11285778|NCT02877927|BG002|Baseline|Total|Total of all reporting groups
11285779|NCT02877927|FG000|Participant Flow|Omadacycline|Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets.
11285780|NCT02877927|FG001|Participant Flow|Linezolid|Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets.
11285781|NCT02877927|OG000|Outcome|Omadacycline|Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets.
11285782|NCT02877927|OG001|Outcome|Linezolid|Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets.
11285783|NCT02877927|EG000|Reported Event|Omadacycline|Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets.
11285784|NCT02877927|EG001|Reported Event|Linezolid|Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets.
11285785|NCT02878057|BG000|Baseline|Advanced Breast Cancer|"Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis;~Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)"
11285786|NCT02878057|FG000|Participant Flow|Advanced Breast Cancer|"Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)~Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)"
11285787|NCT02878057|OG000|Outcome|Advanced Breast Cancer|"Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)~Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)"
11285788|NCT02878057|EG000|Reported Event|Advanced Breast Cancer|"Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)~Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)"
11285789|NCT02878213|BG000|Baseline|D700 System|"Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).~D700 System: Atrial Fibrillation Ablation Procedure"
11285790|NCT02878213|FG000|Participant Flow|D700 (KODEX-EPD) System|"Paroxysmal Atrial Fibrillation (PAF) patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).~D700 (KODEX-EPD) System: Atrial Fibrillation Ablation Procedure"
11285791|NCT02878213|OG000|Outcome|D700 (KODEX-EPD)|ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy in all patients
11285792|NCT02878213|OG000|Outcome|D700 (KODEX-EPD)|All patients in which the KODEX-EPD system was used.
11285793|NCT02878213|EG000|Reported Event|D700 (KODEX-EPD)|All patients in which the KODEX-EPD system was used included in the group.
11285794|NCT02878330|BG000|Baseline|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
11285795|NCT02878330|BG001|Baseline|MEDI8897 50 mg|Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
11285796|NCT02878330|BG002|Baseline|Total|Total of all reporting groups
11285797|NCT02878330|FG000|Participant Flow|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
11285798|NCT02878330|FG001|Participant Flow|MEDI8897 50 mg|Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
11285799|NCT02878330|OG000|Outcome|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
11285800|NCT02878330|OG001|Outcome|MEDI8897 50 mg|Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
11285801|NCT02878330|OG000|Outcome|MEDI8897 50 mg|Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
11285802|NCT02878330|EG000|Reported Event|Placebo|Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
11285803|NCT02878330|EG001|Reported Event|MEDI8897 50 mg|Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
11285804|NCT02878382|BG000|Baseline|All Participants|"Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.~Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose~Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose"
11285805|NCT02878382|FG000|Participant Flow|Calcipotriol Assisted MAL-PDT|Calcipotriol + MAL-PDT half scalp
11285806|NCT02878382|FG001|Participant Flow|Conventional MAL-PDT|MAL-PDT alone half scalp
11285807|NCT02878382|OG000|Outcome|Calcipotriol Assisted MAL-PDT|Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
11285808|NCT02878382|OG001|Outcome|Conventional MAL-PDT|intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
11285809|NCT02878382|OG000|Outcome|Calcipotriol Assisted MAL-PDT|
11285810|NCT02878382|OG001|Outcome|Conventional MAL-PDT|
11285811|NCT02878382|EG000|Reported Event|Calcipotriol Assisted MAL-PDT|"Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT~Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose"
11285812|NCT02878382|EG001|Reported Event|Conventional MAL-PDT|"Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.~Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose"
11285813|NCT02878486|BG000|Baseline|Intervention Group (Jawbone Up Wrist Monitor)|Intervention group will have vibrotactile reminders from a wrist worn device, education about changing sitting habits, and coaching to change habits
11285814|NCT02878486|BG001|Baseline|Control Group (No Wrist Monitor)|Control group will have education about changing sitting habits, no coaching or vibrotactile reminders
11285815|NCT02878486|BG002|Baseline|Total|Total of all reporting groups
11285816|NCT02878486|FG000|Participant Flow|Intervention Group (Jawbone Up Wrist Monitor)|"Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285817|NCT02878486|FG001|Participant Flow|Control Group (No Wrist Monitor)|"Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285818|NCT02878486|OG000|Outcome|Intervention Group (Jawbone Up Wrist Monitor)|"Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285819|NCT02878486|OG001|Outcome|Control Group (No Wrist Monitor)|"Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285820|NCT02878486|EG000|Reported Event|Group 1|"Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285821|NCT02878486|EG001|Reported Event|Group 2|"Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.~Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.~ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand)."
11285822|NCT02878590|BG000|Baseline|At Home Bongo Users|Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
11285823|NCT02878590|FG000|Participant Flow|At Home Bongo Users|Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
11285824|NCT02878590|OG000|Outcome|At Home Bongo Users|Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
11285825|NCT02878590|EG000|Reported Event|BONGO DEVICE|"All participants that qualify will receive the intervention of the Bongo device~BONGO DEVICE: A device to be used for the treatment of mild to moderate obstructive sleep apnea"
11285826|NCT02879032|BG000|Baseline|Patients With Stable Angina|"All patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka for evaluation of stable chest pain were included according to following inclusion and exclusion criteria.~Inclusion criteria:~Male and female patients undergone ETT and CAG within 6 months interval for stable angina. (Fearon et al. 2002)~Age between 30-69 years (Gibbons et al. 2002)~Exclusion criteria:~Previous myocardial infarction by history or ECG~Previous revascularization or valvular heart disease~Baseline abnormalities that may obscure electrocardiographic changes during exercise~Left bundle branch block or Right bundle branch block~Left ventricular hypertrophy with repolarization abnormality~Digitalis therapy~Vantricular paced rhythm~Wolf-Perkinson-White syndrome~ST abnormality associated with supraventricular tachycardia or atrial fibrillation"
11285827|NCT02879032|FG000|Participant Flow|Patients With Stable Angina|"All patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka for evaluation of stable chest pain were included according to following inclusion and exclusion criteria.~Inclusion criteria:~Male and female patients undergone ETT and CAG within 6 months interval for stable angina. (Fearon et al. 2002)~Age between 30-69 years (Gibbons et al. 2002)~Exclusion criteria:~Previous myocardial infarction by history or ECG~Previous revascularization or valvular heart disease~Baseline abnormalities that may obscure electrocardiographic changes during exercise~Left bundle branch block or Right bundle branch block~Left ventricular hypertrophy with repolarization abnormality~Digitalis therapy~Vantricular paced rhythm~Wolf-Perkinson-White syndrome~ST abnormality associated with supraventricular tachycardia or atrial fibrillation"
11285828|NCT02879032|OG000|Outcome|Duke Treadmill Score|Based on the study by Shaw et al. (1998), DTS <+5 is considered abnormal. High risk when DTS is <-10 and low risk when DTS is >+5.
11285829|NCT02879032|OG001|Outcome|Simple Treadmill Score|The simplified score had a rang from 6 to 95, with <40 designated as low probability, between 40-60 was intermediate probability, and >60 was high probability for CAD. STS calculation for male and female subjects was done by formula provided by Raxwal et al. (2002) and Morise et al. (2002), respectively
11285830|NCT02879032|OG002|Outcome|Cleveland Clinic Score|we have assumed CCS will predict significant CAD with high probability if the value is >100 and low probability if it is <80 (Lauer et al. 2007)
11285831|NCT02879032|EG000|Reported Event|Patients With Stable Angina|"All patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka for evaluation of stable chest pain were included according to following inclusion and exclusion criteria.~Inclusion criteria:~Male and female patients undergone ETT and CAG within 6 months interval for stable angina. (Fearon et al. 2002)~Age between 30-69 years (Gibbons et al. 2002)~Exclusion criteria:~Previous myocardial infarction by history or ECG~Previous revascularization or valvular heart disease~Baseline abnormalities that may obscure electrocardiographic changes during exercise~Left bundle branch block or Right bundle branch block~Left ventricular hypertrophy with repolarization abnormality~Digitalis therapy~Vantricular paced rhythm~Wolf-Perkinson-White syndrome~ST abnormality associated with supraventricular tachycardia or atrial fibrillation"
11285832|NCT02879383|BG000|Baseline|DMR Procedure (Europe)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285833|NCT02879383|BG001|Baseline|Sham Procedure (Europe)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285834|NCT02879383|BG002|Baseline|DMR Procedure (Brazil)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285835|NCT02879383|BG003|Baseline|Sham Procedure (Brazil)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285836|NCT02879383|BG004|Baseline|Total|Total of all reporting groups
11285837|NCT02879383|FG000|Participant Flow|DMR Procedure (Europe)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285838|NCT02879383|FG001|Participant Flow|Sham Procedure (Europe)|"Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285839|NCT02879383|FG002|Participant Flow|DMR Procedure (Brazil)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285840|NCT02879383|FG003|Participant Flow|Sham Procedure (Brazil)|"Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285841|NCT02879383|OG000|Outcome|DMR Procedure (Europe)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285842|NCT02879383|OG001|Outcome|Sham Procedure (Europe)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285843|NCT02879383|OG002|Outcome|DMR Procedure (Brazil)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285844|NCT02879383|OG003|Outcome|Sham Procedure (Brazil)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285845|NCT02879383|EG000|Reported Event|DMR Procedure (Europe)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285846|NCT02879383|EG001|Reported Event|Sham Procedure (Europe)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285847|NCT02879383|EG002|Reported Event|DMR Procedure (Brazil)|"Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.~DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System"
11285848|NCT02879383|EG003|Reported Event|Sham Procedure (Brazil)|"Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.~Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient."
11285849|NCT02879383|EG004|Reported Event|Sham Crossover (Europe)|Subjects that were in sham arm (Europe) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
11285850|NCT02879383|EG005|Reported Event|Sham Crossover (Brazil)|Subjects that were in sham arm (Brazil) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
11285851|NCT02879578|BG000|Baseline|Valbenazine (Children)|Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period.
11285852|NCT02879578|BG001|Baseline|Valbenazine (Adolescents)|Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period.
11285853|NCT02879578|BG002|Baseline|Valbenazine (Adults)|Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period.
11285854|NCT02879578|BG003|Baseline|Total|Total of all reporting groups
11285855|NCT02879578|FG000|Participant Flow|Valbenazine (Children)|Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period.
11285856|NCT02879578|FG001|Participant Flow|Valbenazine (Adolescents)|Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period.
11285857|NCT02879578|FG002|Participant Flow|Valbenazine (Adults)|Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period.
11285858|NCT02879578|OG000|Outcome|Valbenazine (Children)|Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period.
11285859|NCT02879578|OG001|Outcome|Valbenazine (Adolescents)|Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period.
11285860|NCT02879578|OG002|Outcome|Valbenazine (Adults)|Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period.
11285861|NCT02879578|EG000|Reported Event|Valbenazine (Children)|Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period.
11285862|NCT02879578|EG001|Reported Event|Valbenazine (Adolescents)|Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period.
11285863|NCT02879578|EG002|Reported Event|Valbenazine (Adults)|Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period.
11285864|NCT02879747|BG000|Baseline|Decreased GH Dose|"Reduced dose 50% Genotropin~Genotropin: Children were randomized to decreased GH dose by 50% after 2-3 years of Catch-up growth"
11285865|NCT02879747|BG001|Baseline|Unchanged GH Dose|"Unchanged dose Genotropin~Genotropin: Children were randomized to unchanged GH dose after 2-3 years of Catch-up growth"
11285866|NCT02879747|BG002|Baseline|Control Group|"Control Group randomized in the previous study to fix dose.~This group of children continued with fix dose in the current trial after signing informed consent."
11285867|NCT02879747|BG003|Baseline|Total|Total of all reporting groups
11285868|NCT02879747|FG000|Participant Flow|Decreased GH Dose|"Decreased GH dose Genotropin~Genotropin: Children were randomized to 50% GH dose after 2-3 years of initial GH treatment in previous trial (years depending on achieved Catch-up)"
11285869|NCT02879747|FG001|Participant Flow|Unchanged GH Dose|"Unchanged GH dose~Genotropin: Children were randomized to unchanged dose after 2-3 years of initial GH treatment in previous trial (years depending on achieved Catch-up)"
11285870|NCT02879747|FG002|Participant Flow|Control Group|Control Group with informed consent but not randomized
11285871|NCT02879747|OG000|Outcome|Decreased GH Dose|"Decreased GH dose Genotropin~Genotropin: Children were randomized to 50% GH dose after 2-3 years of initial GH treatment in previous trial (years depending on achieved Catch-up)"
11285872|NCT02879747|OG001|Outcome|Interventional 2|"Unchanged GH dose~Genotropin: Children were randomized to unchanged dose after 2-3 years of initial GH treatment in previous trial (years depending on achieved Catch-up)"
11285873|NCT02879747|OG002|Outcome|Control Group|Control Group children with fix dose through the previous and current trial and with signed consent
11285874|NCT02879747|OG000|Outcome|Unchanged Dose|"Unchanged dose Genotropin~Genotropin: Children were randomized to unchanged GH dose after 2-3 years of Catch-up growth"
11285875|NCT02879747|OG001|Outcome|Reduced Dose|"reduced dose 50% Genotropin~Genotropin: Children were randomized to decreased GH dose by 50% after 2-3 years of Catch-up growth"
11285876|NCT02879747|OG002|Outcome|Control Group|Control Group treated with fix dose GH according to previous and current trial, with signed informed consent
11285877|NCT02879747|OG000|Outcome|Decreased GH Dose|Children were randomized to decreased GH dose by 50% after 2-3 years of Catch-up growth
11285878|NCT02879747|OG001|Outcome|Unchanged GH Dose|Children were randomized to unchanged GH dose after 2-3 years of Catch-up growth
11285879|NCT02879747|OG002|Outcome|Control Group|Randomized in the previous study to fix dose. This Group of Children continued with fix dose in the current trial
11285880|NCT02879747|OG000|Outcome|Unchanged Dose|"Unchanged dose Genotropin~Genotropin: Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth"
11285881|NCT02879747|OG001|Outcome|Reduced Dose|"reduced dose 50% Genotropin~Genotropin: Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth"
11285882|NCT02879747|OG002|Outcome|Control Group|Control Group with fix dose throughout the previous and current trial. Signed informed consent.
11285883|NCT02879747|EG000|Reported Event|Decreased GH Dose|Reduced dose 50% Genotropin Children were randomized to decreased GH dose by 50% after 2-3 years of Catch-up growth
11285884|NCT02879747|EG001|Reported Event|Unchanged GH Dose|"Unchanged dose~Children were randomized to unchanged dose after 2-3 years of Catch-up growth"
11285885|NCT02879747|EG002|Reported Event|Control Group|"Control Group with fix dose.~Children that were randomized to fix dose in the previous and current trial and signed informed consent"
11285886|NCT02879812|BG000|Baseline|Multi-Component Intervention|End Stage Renal Disease (ESRD) facilities will receive performance feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, an educational video for patients and staff; and United Network for Organ Sharing (UNOS) Pamphlet for dialysis facility staff detailing the changes in the new kidney allocation policy .
11285887|NCT02879812|BG001|Baseline|Standard Care + Pamphlet|"End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.~Standard Care: Dialysis facilities will conduct standard or usual care and education regarding transplantation.~United Network for Organ Sharing (UNOS) Pamphlet: Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy ."
11285888|NCT02879812|BG002|Baseline|Total|Total of all reporting groups
11285889|NCT02879812|FG000|Participant Flow|Multi-Component Intervention|End Stage Renal Disease (ESRD) facilities will receive performance feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, an educational video for patients and staff; and United Network for Organ Sharing (UNOS) Pamphlet for dialysis facility staff detailing the changes in the new kidney allocation policy .
11285890|NCT02879812|FG001|Participant Flow|Standard Care + Pamphlet|"End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.~Standard Care: Dialysis facilities will conduct standard or usual care and education regarding transplantation.~United Network for Organ Sharing (UNOS) Pamphlet: Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy ."
11285891|NCT02879812|OG000|Outcome|Multi-Component Intervention|End Stage Renal Disease (ESRD) facilities will receive performance feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, an educational video for patients and staff; and United Network for Organ Sharing (UNOS) Pamphlet for dialysis facility staff detailing the changes in the new kidney allocation policy .
11285892|NCT02879812|OG001|Outcome|Standard Care + Pamphlet|"End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.~Standard Care: Dialysis facilities will conduct standard or usual care and education regarding transplantation.~United Network for Organ Sharing (UNOS) Pamphlet: Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy ."
11285893|NCT02879812|EG000|Reported Event|Multi-Component Intervention|End Stage Renal Disease (ESRD) facilities will receive performance feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, an educational video for patients and staff; and United Network for Organ Sharing (UNOS) Pamphlet for dialysis facility staff detailing the changes in the new kidney allocation policy .
11285894|NCT02879812|EG001|Reported Event|Standard Care + Pamphlet|"End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.~Standard Care: Dialysis facilities will conduct standard or usual care and education regarding transplantation.~United Network for Organ Sharing (UNOS) Pamphlet: Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy ."
11215274|NCT02298179|FG009|Participant Flow|RSV F 135 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
11215275|NCT02298179|FG010|Participant Flow|RSV F 135 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
11215276|NCT02298179|FG011|Participant Flow|Placebo 3 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
11215277|NCT02298179|OG000|Outcome|RSV F 45 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
11215278|NCT02298179|OG001|Outcome|RSV F 45 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
11215279|NCT02298179|OG002|Outcome|RSV F 45 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
11215280|NCT02298179|OG003|Outcome|Placebo 1 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
11215281|NCT02298179|OG004|Outcome|RSV F 90 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
11215282|NCT02298179|OG005|Outcome|RSV F 90 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
11215283|NCT02298179|OG006|Outcome|RSV F 90 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
11215284|NCT02298179|OG007|Outcome|Placebo 2 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
11215285|NCT02298179|OG008|Outcome|RSV F 135 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
11215286|NCT02298179|OG009|Outcome|RSV F 135 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
11215287|NCT02298179|OG010|Outcome|RSV F 135 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
11215288|NCT02298179|OG011|Outcome|Placebo 3 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
11215289|NCT02298179|EG000|Reported Event|RSV F 45 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
11215290|NCT02298179|EG001|Reported Event|RSV F 45 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
11215291|NCT02298179|EG002|Reported Event|RSV F 45 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
11215292|NCT02298179|EG003|Reported Event|Placebo 1 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
11215293|NCT02298179|EG004|Reported Event|RSV F 90 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
11215294|NCT02298179|EG005|Reported Event|RSV F 90 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
11215295|NCT02298179|EG006|Reported Event|RSV F 90 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
11215296|NCT02298179|EG007|Reported Event|Placebo 2 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
11285895|NCT02879994|BG000|Baseline|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11285896|NCT02879994|FG000|Participant Flow|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11285897|NCT02879994|OG000|Outcome|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11285898|NCT02879994|EG000|Reported Event|Treatment (Pembrolizumab)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pembrolizumab: Given IV"
11285899|NCT02880137|BG000|Baseline|RTMPE|"RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.~Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.~RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease."
11285900|NCT02880137|FG000|Participant Flow|RTMPE|"RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for cardiac allograft vasculopathy (CAV) detection.~Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.~RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease."
11285901|NCT02880137|OG000|Outcome|RTMPE|"RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.~Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.~RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease."
11285902|NCT02880137|EG000|Reported Event|RTMPE|"RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.~Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.~RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease."
11285903|NCT02880176|BG000|Baseline|Financial Incentive|"Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.~Subjects will use Fitbit Zip to track step counts"
11285904|NCT02880176|BG001|Baseline|Control (Education)|Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
11285905|NCT02880176|BG002|Baseline|Total|Total of all reporting groups
11285906|NCT02880176|FG000|Participant Flow|Financial Incentive|"Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.~Subjects will use Fitbit Zip to track step counts"
11285907|NCT02880176|FG001|Participant Flow|Control (Education)|Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
11285908|NCT02880176|OG000|Outcome|Financial Incentive|"Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.~Subjects will use Fitbit Zip to track step counts"
11285909|NCT02880176|OG001|Outcome|Control (Education)|Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
11285910|NCT02880176|EG000|Reported Event|Financial Incentive|"Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.~Subjects will use Fitbit Zip to track step counts"
11285911|NCT02880176|EG001|Reported Event|Control (Education)|Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
11285912|NCT02880228|BG000|Baseline|Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)|Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
11285913|NCT02880228|FG000|Participant Flow|Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)|Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
11285914|NCT02880228|OG000|Outcome|Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)|Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
11285915|NCT02880228|EG000|Reported Event|Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)|Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
11285916|NCT02880254|BG000|Baseline|Kurbo Only|"use of app plus standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits"
11285917|NCT02880254|BG001|Baseline|Kurbo Plus PHC|"use of app, personal health coach and standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits~Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process"
11285918|NCT02880254|BG002|Baseline|Total|Total of all reporting groups
11285919|NCT02880254|FG000|Participant Flow|Kurbo Only|"use of app plus standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits"
11285920|NCT02880254|FG001|Participant Flow|Kurbo Plus PHC|"use of app, personal health coach and standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits~Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process"
11285921|NCT02880254|OG000|Outcome|Kurbo Only|"use of app plus standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits"
11285922|NCT02880254|OG001|Outcome|Kurbo Plus PHC|"use of app, personal health coach and standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits~Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process"
11285923|NCT02880254|EG000|Reported Event|Kurbo Only|"use of app plus standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits"
11285924|NCT02880254|EG001|Reported Event|Kurbo Plus PHC|"use of app, personal health coach and standard of care~Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits~Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process"
11285925|NCT02880475|BG000|Baseline|OXN PR Tablet 5/2.5 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285926|NCT02880475|BG001|Baseline|OXN PR Tablet 20/10 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285927|NCT02880475|BG002|Baseline|Total|Total of all reporting groups
11285928|NCT02880475|FG000|Participant Flow|OXN Prolonged Release Tablet 5/2.5 mg|"The subjects were randomized to receive a single dose of OXN prolonged release tablets 5/2.5mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg"
11285929|NCT02880475|FG001|Participant Flow|OXN Prolonged Release Tablet 20/10 mg|"The subjects were randomized to receive a single dose of OXN prolonged release tablets 20/10mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 20/10 mg"
11285930|NCT02880475|OG000|Outcome|OXN PR Tablet 5/2.5 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285931|NCT02880475|OG001|Outcome|OXN PR Tablet 20/10 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285932|NCT02880475|OG000|Outcome|OXN Prolonged Release Tablet 5/2.5mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/2.5mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285933|NCT02880475|OG001|Outcome|OXN Prolonged Release Tablet 20/10mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285934|NCT02880475|EG000|Reported Event|OXN PR Tablet 5/2.5 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11215297|NCT02298179|EG008|Reported Event|RSV F 135 No Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
11215298|NCT02298179|EG009|Reported Event|RSV F 135 Alum Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
11215299|NCT02298179|EG010|Reported Event|RSV F 135 MF59 Adj Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
11215300|NCT02298179|EG011|Reported Event|Placebo 3 Group|Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
11215301|NCT02298192|BG000|Baseline|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
11215302|NCT02298192|BG001|Baseline|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
11215303|NCT02298192|BG002|Baseline|Total|Total of all reporting groups
11215304|NCT02298192|FG000|Participant Flow|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
11215305|NCT02298192|FG001|Participant Flow|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
11215306|NCT02298192|OG000|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
11215307|NCT02298192|OG001|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
11215308|NCT02298192|EG000|Reported Event|IDegLira (1WT)|Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
11285935|NCT02880475|EG001|Reported Event|OXN PR Tablet 20/10 mg|"The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time.~OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg"
11285936|NCT02880514|BG000|Baseline|All Study Participants|This study used an intra-patient design with each participant having one sinus side randomized to the treatment group and the other to the control group.
11285937|NCT02880514|FG000|Participant Flow|PROPEL Mini Sinus Implant|Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) after a successful in-office balloon dilation
11285938|NCT02880514|FG001|Participant Flow|Balloon Sinus Dilation Alone|Successful in-office balloon dilation of the frontal sinus ostia (FSO) without implant placement
11285939|NCT02880514|OG000|Outcome|PROPEL Mini Sinus Implant|Placement of the Propel Mini Sinus Implant in the frontal sinus ostia (FSO) after a successful in-office balloon dilation
11285940|NCT02880514|OG001|Outcome|Balloon Sinus Dilation Alone|Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) without implant placement
11285941|NCT02880514|OG000|Outcome|PROPEL Mini Sinus Implant|Placement of Propel Mini Sinus Implant after a successful in-office balloon dilation of the frontal sinus ostia (FSO)
11285942|NCT02880514|OG001|Outcome|Balloon Sinus Dilation Alone|Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) only without implant placement
11285943|NCT02880514|EG000|Reported Event|All Participants|An intra-patient control design with placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation compared to in-office balloon dilation without implant placement of the contralateral frontal sinus ostia (FSO) assigned to the control group.
11285944|NCT02880761|BG000|Baseline|Intervention|"Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.~Assessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"
11285945|NCT02880761|BG001|Baseline|Control|Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.
11285946|NCT02880761|BG002|Baseline|Total|Total of all reporting groups
11285947|NCT02880761|FG000|Participant Flow|Intervention|"Patients with native arterovenous fistula (AVF) will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.~Assessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"
11285948|NCT02880761|FG001|Participant Flow|Control|Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.
11285949|NCT02880761|OG000|Outcome|Intervention|"Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.~Assessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"
11285950|NCT02880761|OG001|Outcome|Control|Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.
11285951|NCT02880761|EG000|Reported Event|Intervention|"Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.~Assessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"
11285952|NCT02880761|EG001|Reported Event|Control|Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.
11285953|NCT02880852|BG000|Baseline|Belimumab 10 mg/kg|Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
11285954|NCT02880852|FG000|Participant Flow|Belimumab 10 mg/kg|Eligible participants received a single dose of belimumab 10 milligrams (mg) per kilogram (kg) as intravenous infusion for over an hour on Day 0.
11285955|NCT02880852|OG000|Outcome|Belimumab 10 mg/kg|Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
11285956|NCT02880852|EG000|Reported Event|Belimumab 10 mg/kg|Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
11285957|NCT02880865|BG000|Baseline|Group 1: MMR and CD-JEV|Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285958|NCT02880865|BG001|Baseline|Group 2: MMR Then CD-JEV|Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285959|NCT02880865|BG002|Baseline|Total|Total of all reporting groups
11285960|NCT02880865|FG000|Participant Flow|Group 1: MMR and CD-JEV|Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285961|NCT02880865|FG001|Participant Flow|Group 2: MMR Then CD-JEV|Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285962|NCT02880865|OG000|Outcome|Group 1: MMR and CD-JEV|Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285963|NCT02880865|OG001|Outcome|Group 2: MMR Then CD-JEV|Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285964|NCT02880865|OG000|Outcome|Group 1 - MMR and CD-JEV|Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285965|NCT02880865|OG001|Outcome|Group 2 - MMR Then CD-JEV|Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).
11285966|NCT02880865|OG000|Outcome|Group 1: MMR Dose 1 + CD-JEV|Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.
11285967|NCT02880865|OG001|Outcome|Group 2: MMR Dose 1|Participants in Group 2 received one dose of MMR vaccine on Day 0.
11285968|NCT02880865|OG002|Outcome|Group 2: CD-JEV|Participants in Group 2 received one dose of CD-JEV on Day 56.
11285969|NCT02880865|OG003|Outcome|Group 1: MMR Dose 2|Participants in Group 1 received a second dose of MMR vaccine on Day 84.
11092481|NCT01540266|BG000|Baseline|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
11285970|NCT02880865|OG004|Outcome|Group 2: MMR Dose 2|Participants in Group 2 received a second dose of MMR vaccine on Day 84.
11285971|NCT02880865|OG000|Outcome|Group 1: MMR Dose 1|Participants in Group 1 received one dose of MMR vaccine injected on the left upper thigh on Day 0.
11285972|NCT02880865|OG001|Outcome|Group 1: CD-JEV|Participants in Group 1 received one dose of CD-JEV vaccine injected on the right upper thigh on Day 0.
11285973|NCT02880865|OG002|Outcome|Group 2: MMR Dose 1|Participants in Group 2 received one dose of MMR vaccine injected on the left upper thigh on Day 0.
11285974|NCT02880865|OG003|Outcome|Group 2: CD-JEV|Participants in Group 2 received one dose of CD-JEV vaccine injected on the left upper thigh on Day 56.
11285975|NCT02880865|OG004|Outcome|Group 1: MMR Dose 2|Participants in Group 1 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
11285976|NCT02880865|OG005|Outcome|Group 2: MMR Dose 2|Participants in Group 2 received a 2nd dose of MMR vaccine injected on the left upper thigh on Day 84.
11285977|NCT02880865|OG000|Outcome|Group 1: MMR Dose 1 + CD-JEV|Participants in Group 1 received one dose of MMR vaccine and one dose of CD-JEV concurrently on Day 0.
11285978|NCT02880865|OG002|Outcome|Group 2: CD-JEV|Participants in Group 2 received one dose of CD-JEV vaccine on Day 56.
11285979|NCT02880865|OG001|Outcome|Group 2: MMR Dose 1|Participants in Group 2 received one dose of MMR vaccine at Day 0.
11285980|NCT02880865|OG000|Outcome|Group 1: MMR and CD-JEV|Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0. Participants received a second dose of MMR per the routine immunization schedule on Day 84 (12 months of age).
11285981|NCT02880865|OG001|Outcome|Group 2: MMR Then CD-JEV|Participants received one dose of MMR vaccine on Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule on Day 84 (12 months of age).
11285982|NCT02880865|EG000|Reported Event|Group 1: MMR Dose 1 + CD-JEV|Participants in Group 1 received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently on Day 0.
11285983|NCT02880865|EG001|Reported Event|Group 2: MMR Dose 1|Participants in Group 2 received one dose of MMR vaccine at Day 0.
11285984|NCT02880865|EG002|Reported Event|Group 2: CD-JEV|Participants in Group 2 received one dose of CD-JEV on Day 56.
11285985|NCT02880865|EG003|Reported Event|Group 1: MMR Dose 2|Participants in Group 1 received a second dose of MMR vaccine on Day 84.
11285986|NCT02880865|EG004|Reported Event|Group 2: MMR Dose 2|Participants in Group 2 received a second dose of MMR vaccine on Day 84.
11285987|NCT02881008|BG000|Baseline|Arm A|Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285988|NCT02881008|BG001|Baseline|Arm B|Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285989|NCT02881008|BG002|Baseline|Arm C|Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285990|NCT02881008|BG003|Baseline|Arm D|Entecavir 0.5 mg daily for 24 weeks
11285991|NCT02881008|BG004|Baseline|Arm E|Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285992|NCT02881008|BG005|Baseline|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11285993|NCT02881008|BG006|Baseline|Total|Total of all reporting groups
11285994|NCT02881008|FG000|Participant Flow|Arm A|Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285995|NCT02881008|FG001|Participant Flow|Arm B|Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285996|NCT02881008|FG002|Participant Flow|Arm C|Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285997|NCT02881008|FG003|Participant Flow|Arm D|Entecavir 0.5 mg daily for 24 weeks
11285998|NCT02881008|FG004|Participant Flow|Arm E|Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11285999|NCT02881008|FG005|Participant Flow|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11286000|NCT02881008|OG000|Outcome|Arm A|Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286001|NCT02881008|OG001|Outcome|Arm B|Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286002|NCT02881008|OG002|Outcome|Arm C|Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286003|NCT02881008|OG003|Outcome|Arm D|Entecavir 0.5 mg daily for 24 weeks
11286004|NCT02881008|OG004|Outcome|Arm E|Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286005|NCT02881008|OG005|Outcome|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11286006|NCT02881008|OG000|Outcome|Arm D|Entecavir 0.5 mg daily for 24 weeks
11286007|NCT02881008|OG001|Outcome|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11286008|NCT02881008|OG000|Outcome|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11286009|NCT02881008|EG000|Reported Event|Arm A|Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286010|NCT02881008|EG001|Reported Event|Arm B|Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286011|NCT02881008|EG002|Reported Event|Arm C|Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286012|NCT02881008|EG003|Reported Event|Arm D|Entecavir 0.5 mg daily for 24 weeks
11286013|NCT02881008|EG004|Reported Event|Arm E|Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
11286014|NCT02881008|EG005|Reported Event|Arm F|Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
11286015|NCT02881047|BG000|Baseline|rAblative Fractional Laser for Sclerotic GVHD-Associated Joint|"Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb~CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.~Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.~Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.~Photography: Photography of the affected area / intended treatment area."
11286016|NCT02881047|FG000|Participant Flow|rAblative Fractional Laser for Sclerotic GVHD-Associated Joint|"Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb~CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.~Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.~Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.~Photography: Photography of the affected area / intended treatment area."
11286017|NCT02881047|OG000|Outcome|rAblative Fractional Laser for Sclerotic GVHD-Associated Joint|"Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb~CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.~Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.~Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.~Photography: Photography of the affected area / intended treatment area."
11286018|NCT02881047|EG000|Reported Event|rAblative Fractional Laser for Sclerotic GVHD-Associated Joint|"Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb~CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.~Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.~Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.~Photography: Photography of the affected area / intended treatment area."
11286019|NCT02881112|BG000|Baseline|Active Treatment Arm|"Treatment with Provant Therapy System~Provant Therapy System: Treatment with the Provant Therapy System"
11286020|NCT02881112|FG000|Participant Flow|Active Treatment Arm|"Treatment with Provant Therapy System~Provant Therapy System: Treatment with the Provant Therapy System"
11286021|NCT02881112|OG000|Outcome|Active Treatment Arm|"Treatment with Provant Therapy System~Provant Therapy System: Treatment with the Provant Therapy System"
11286022|NCT02881112|EG000|Reported Event|Active Treatment Arm|"Treatment with Provant Therapy System~Provant Therapy System: Treatment with the Provant Therapy System"
11286023|NCT02881567|BG000|Baseline|Daclizumab|Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
11286024|NCT02881567|FG000|Participant Flow|Daclizumab|Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
11286025|NCT02881567|OG000|Outcome|Daclizumab|Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
11286026|NCT02881567|EG000|Reported Event|Daclizumab|Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
11286027|NCT02881658|BG000|Baseline|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
11286028|NCT02881658|BG001|Baseline|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
11286029|NCT02881658|BG002|Baseline|Total|Total of all reporting groups
11286030|NCT02881658|FG000|Participant Flow|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
11286031|NCT02881658|FG001|Participant Flow|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
11286032|NCT02881658|OG000|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
11286033|NCT02881658|OG001|Outcome|Soya Beverage Provided by Vitasoy|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
11286034|NCT02881658|OG000|Outcome|Plant Sterols-enriched Soya Beverage Provided by Vitasoy|Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
11286035|NCT02881658|OG001|Outcome|Soya Beverage Provided by Vitasoy|Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
11286036|NCT02881658|EG000|Reported Event|Plant Sterols-enriched Soya Beverage|"Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage"
11286037|NCT02881658|EG001|Reported Event|Soya Beverage|"Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).~Soya beverage: the placebo product is a 250 ml soya beverage"
11286038|NCT02881775|BG000|Baseline|All Study Participants|Participants who were randomized to receive either rTMS and exercise or sham rTMS and exercise.
11286039|NCT02881775|FG000|Participant Flow|rTMS and Exercise, Then Sham rTMS and Exercise|"At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.~rTMS and exercise: rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)~Sham rTMS and exercise: rTMS unit is on and running but mu metal is placed between the coil and the skull"
11286040|NCT02881775|FG001|Participant Flow|Sham rTMS and Exercise, Then rTMS and Exercise|"At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the true rTMS and exercise using the same parameters.~rTMS and exercise: rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)~Sham rTMS and exercise: rTMS unit is on and running but mu metal is placed between the coil and the skull"
11286041|NCT02881775|OG000|Outcome|rTMS and Exercise|At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
11286042|NCT02881775|OG001|Outcome|Sham rTMS and Exercise|"At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the true rTMS and exercise using the same parameters."
11286043|NCT02881775|EG000|Reported Event|rTMS and Exercise|At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
11286044|NCT02881775|EG001|Reported Event|Sham rTMS and Exercise|"At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the true rTMS and exercise using the same parameters."
11286045|NCT02881840|BG000|Baseline|14C-APD421 Amisulpride|Single IV dose administration as an infusion over a 4 minute period
11286046|NCT02881840|FG000|Participant Flow|14C-APD421|[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
11286047|NCT02881840|OG000|Outcome|14C-APD421|[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
11286048|NCT02881840|EG000|Reported Event|14C-APD421|[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
11286049|NCT02881996|BG000|Baseline|IV Tylenol|"Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.~IV tylenol: IV tylenol given scheduled in addition to standard PCA~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286050|NCT02881996|BG001|Baseline|No IV Tylenol|"Same as above without IV tylenol.~No IV tylenol: No additional IV Tylenol given~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286051|NCT02881996|BG002|Baseline|Total|Total of all reporting groups
11286052|NCT02881996|FG000|Participant Flow|IV Tylenol|"Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.~IV tylenol: IV tylenol given scheduled in addition to standard PCA~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286053|NCT02881996|FG001|Participant Flow|No IV Tylenol|"Same as above without IV tylenol.~No IV tylenol: No additional IV Tylenol given~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286054|NCT02881996|OG000|Outcome|IV Tylenol|"Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.~IV tylenol: IV tylenol given scheduled in addition to standard PCA~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286055|NCT02881996|OG001|Outcome|No IV Tylenol|"Same as above without IV tylenol.~No IV tylenol: No additional IV Tylenol given~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286056|NCT02881996|EG000|Reported Event|IV Tylenol|"Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.~IV tylenol: IV tylenol given scheduled in addition to standard PCA~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286057|NCT02881996|EG001|Reported Event|No IV Tylenol|"Same as above without IV tylenol.~No IV tylenol: No additional IV Tylenol given~Ketorolac: both groups receive as part of our standard postop pain protocol after all operations"
11286058|NCT02882152|BG000|Baseline|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
11286059|NCT02882152|BG001|Baseline|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
11286060|NCT02882152|BG002|Baseline|Total|Total of all reporting groups
11286061|NCT02882152|FG000|Participant Flow|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
11286062|NCT02882152|FG001|Participant Flow|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
11286063|NCT02882152|OG000|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
11286064|NCT02882152|OG001|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
10847454|NCT00283296|FG000|Participant Flow|Endeavor Wheelchair|All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
11286065|NCT02882152|EG000|Reported Event|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
11286066|NCT02882152|EG001|Reported Event|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
11286067|NCT02882178|BG000|Baseline|Experts of the Consensus Process|Experts involved in the consensus process
11286068|NCT02882178|FG000|Participant Flow|Experts of the Consensus Process|Experts involved in the consensus process
11286069|NCT02882178|OG000|Outcome|Experts of the Consensus Process|Experts involved in the consensus process
11286070|NCT02882178|EG000|Reported Event|Experts of the Consensus Process|Experts involved in the consensus process
11286071|NCT02882633|BG000|Baseline|Lumbar Plexus Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286072|NCT02882633|BG001|Baseline|Fascia Iliaca Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286073|NCT02882633|BG002|Baseline|Total|Total of all reporting groups
11286074|NCT02882633|FG000|Participant Flow|Lumbar Plexus Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286075|NCT02882633|FG001|Participant Flow|Fascia Iliac Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286076|NCT02882633|OG000|Outcome|Lumbar Plexus Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286077|NCT02882633|OG001|Outcome|Fascia Iliac Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286078|NCT02882633|EG000|Reported Event|Lumbar Plexus Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286079|NCT02882633|EG001|Reported Event|Fascia Iliac Block|"Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain~30ml bolus of bupivacaine: Local anesthetic"
11286080|NCT02882711|BG000|Baseline|Ketamine|Ketamine: Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
11286081|NCT02882711|FG000|Participant Flow|Ketamine|Ketamine: Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
11286082|NCT02882711|OG000|Outcome|Ketamine|Ketamine: Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
11286083|NCT02882711|EG000|Reported Event|Ketamine|Ketamine: Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
11286084|NCT02882854|BG000|Baseline|Guanfacine|"Guanfacine 1 mg capsule by mouth, one time prior to surgery.~Guanfacine: Patients will receive 1 mg of guanfacine to take orally."
11286085|NCT02882854|BG001|Baseline|Placebo|"Placebo with a similar appearance to guanfacine by mouth one time prior to surgery~Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally."
11286086|NCT02882854|BG002|Baseline|Total|Total of all reporting groups
11286087|NCT02882854|FG000|Participant Flow|Guanfacine|"Guanfacine 1 mg capsule by mouth, one time prior to surgery.~Guanfacine: Patients will receive 1 mg of guanfacine to take orally."
11286088|NCT02882854|FG001|Participant Flow|Placebo|"Placebo with a similar appearance to guanfacine by mouth one time prior to surgery~Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally."
11286089|NCT02882854|OG000|Outcome|Guanfacine|"Guanfacine 1 mg capsule by mouth, one time prior to surgery.~Guanfacine: Patients will receive 1 mg of guanfacine to take orally."
11286090|NCT02882854|OG001|Outcome|Placebo|"Placebo with a similar appearance to guanfacine by mouth one time prior to surgery~Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally."
11286091|NCT02882854|EG000|Reported Event|Guanfacine|"Guanfacine 1 mg capsule by mouth, one time prior to surgery.~Guanfacine: Patients will receive 1 mg of guanfacine to take orally."
11286092|NCT02882854|EG001|Reported Event|Placebo|"Placebo with a similar appearance to guanfacine by mouth one time prior to surgery~Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally."
11286093|NCT02883244|BG000|Baseline|Soft-Picks Advanced|"Device: Curved Soft-Picks~Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home."
11286094|NCT02883244|BG001|Baseline|Floss|"Device: Waxed tape floss~Floss: Floss will be used once a day to clean interdental sites at home."
11286095|NCT02883244|BG002|Baseline|Total|Total of all reporting groups
11286096|NCT02883244|FG000|Participant Flow|Floss|"Device: Waxed tape floss~Floss: Floss will be used once a day to clean interdental sites at home."
11286097|NCT02883244|FG001|Participant Flow|Soft-Picks Advanced|"Device: Curved Soft-Picks~Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home."
11286098|NCT02883244|OG000|Outcome|Soft-Picks Advanced|"Device: Curved Soft-Picks~Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home."
11286099|NCT02883244|OG001|Outcome|Floss|"Device: Waxed tape floss~Floss: Floss will be used once a day to clean interdental sites at home."
11286100|NCT02883244|EG000|Reported Event|Soft-Picks Advanced|"Device: Curved Soft-Picks~Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home."
11286101|NCT02883244|EG001|Reported Event|Floss|"Device: Waxed tape floss~Floss: Floss will be used once a day to clean interdental sites at home."
11286102|NCT02883452|BG000|Baseline|Cohort 1: CT-P13 IV 5 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
11286103|NCT02883452|BG001|Baseline|Cohort 2: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
11286104|NCT02883452|BG002|Baseline|Cohort 3: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
11286105|NCT02883452|BG003|Baseline|Cohort 4: CT-P13 SC 240 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
11286106|NCT02883452|BG004|Baseline|Arm 1: CT-P13 SC 120/240 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
11286107|NCT02883452|BG005|Baseline|Arm 2: CT-P13 IV 5 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
11286108|NCT02883452|BG006|Baseline|Total|Total of all reporting groups
11286109|NCT02883452|FG000|Participant Flow|Cohort 1: CT-P13 IV 5 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
11286110|NCT02883452|FG001|Participant Flow|Cohort 2: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
11286111|NCT02883452|FG002|Participant Flow|Cohort 3: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
11286112|NCT02883452|FG003|Participant Flow|Cohort 4: CT-P13 SC 240 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
11286113|NCT02883452|FG004|Participant Flow|Arm 1: CT-P13 SC 120/240 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
11286114|NCT02883452|FG005|Participant Flow|Arm 2: CT-P13 IV 5 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
11286115|NCT02883452|OG000|Outcome|Cohort 1: CT-P13 IV 5mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
11286116|NCT02883452|OG001|Outcome|Cohort 2: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
11286117|NCT02883452|OG002|Outcome|Cohort 3: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
11286118|NCT02883452|OG003|Outcome|Cohort 4: CT-P13 SC 240 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
11286119|NCT02883452|OG000|Outcome|Arm 1: CT-P13 SC 120/240 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
11286120|NCT02883452|OG001|Outcome|Arm 2: CT-P13 IV 5 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
10847455|NCT00283296|OG000|Outcome|Endeavor Wheelchair|All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
11287189|NCT02899195|FG000|Participant Flow|Concurrent Durvalumab Then Maintenance Durvalumab|"Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion.~Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration.~After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment.~Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes."
11287190|NCT02899195|OG000|Outcome|Concurrent Durvalumab Then Maintenance Durvalumab|"Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion.~Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration.~After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment.~Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes."
11287191|NCT02899195|EG000|Reported Event|Concurrent Durvalumab Then Maintenance Durvalumab|"Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion.~Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration.~After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment.~Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes."
11287192|NCT02899338|BG000|Baseline|BI695501 Prefilled Syringe|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using a prefilled syringe (PFS).
11287193|NCT02899338|BG001|Baseline|BI695501 Autoinjector|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using an autoinjector (AI).
11287194|NCT02899338|BG002|Baseline|Total|Total of all reporting groups
11287195|NCT02899338|FG000|Participant Flow|BI695501 Prefilled Syringe|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using a prefilled syringe (PFS).
11287196|NCT02899338|FG001|Participant Flow|BI695501 Autoinjector|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using an autoinjector (AI).
11287197|NCT02899338|OG000|Outcome|BI695501 Prefilled Syringe|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using a prefilled syringe (PFS).
11287198|NCT02899338|OG001|Outcome|BI695501 Autoinjector|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using an autoinjector (AI).
11287199|NCT02899338|EG000|Reported Event|BI695501 Autoinjector|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using an autoinjector (AI).
11287200|NCT02899338|EG001|Reported Event|BI695501 Prefilled Syringe|Patients were administered a single subcutaneous dose of 40 milligram (mg)/0.8 milliliter (mL) BI 695501 (solution for injection) using a prefilled syringe (PFS).
11287201|NCT02899377|BG000|Baseline|Healthy Participants|Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
11287202|NCT02899377|BG001|Baseline|Participants With pSS|Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
11287203|NCT02899377|BG002|Baseline|Total|Total of all reporting groups
11287204|NCT02899377|FG000|Participant Flow|Healthy Participants|Underwent an MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 millimoles (mmol)/kilogram (kg) of gadoterate meglumine and received one-time IV bolus injection of 500 megabecquerels (MBq) of carbon11-methionine (11C -MET) followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
11287205|NCT02899377|FG001|Participant Flow|Participants With pSS|Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-flurodeoxyglucose (FDG) followed by a PET/CT (static head to hip scan).
11287206|NCT02899377|OG000|Outcome|Participants With pSS|Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
11287207|NCT02899377|OG001|Outcome|Healthy Participants|Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
11287208|NCT02899377|OG000|Outcome|Healthy Participants|Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
11287209|NCT02899377|OG001|Outcome|Participants With pSS|Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
11287210|NCT02899377|EG000|Reported Event|Healthy Participants|Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
11287211|NCT02899377|EG001|Reported Event|Participants With pSS|Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
11287212|NCT02899650|BG000|Baseline|Young Fit|Young (18-39 yrs) people who have endurance training habit
11287213|NCT02899650|BG001|Baseline|Young Unfit|Young (18-39 yrs) people who have sedentary lifestyle
11287214|NCT02899650|BG002|Baseline|Older Fit|Older (50-80 yrs) people who have endurance training habit
11287215|NCT02899650|BG003|Baseline|Total|Total of all reporting groups
11287216|NCT02899650|FG000|Participant Flow|Young Fit|Young (18-39 yrs) people who have endurance training habit
11287217|NCT02899650|FG001|Participant Flow|Young Unfit|Young (18-39 yrs) people who have sedentary lifestyle
11287218|NCT02899650|FG002|Participant Flow|Older Fit|Older (50-80 yrs) people who have endurance training habit
11287219|NCT02899650|FG003|Participant Flow|Older Unfit|Older (50-80 yrs) people who have sedentary lifestyle
11287220|NCT02899650|OG000|Outcome|Young Fit|"Young (18-39 yrs) people who have endurance training habit~exercise: acute downhill running"
11287221|NCT02899650|OG001|Outcome|Young Unfit|"Young (18-39 yrs) people who have sedentary lifestyle.~exercise: acute downhill running"
11287222|NCT02899650|OG002|Outcome|Older Fit|"Older (50-80 yrs) people who have endurance training habit~exercise: acute downhill running"
11287223|NCT02899650|EG000|Reported Event|Young Fit|"Young (18-39 yrs) people who have endurance training habit~exercise: acute downhill running"
11287224|NCT02899650|EG001|Reported Event|Young Unfit|"Young (18-39 yrs) people who have sedentary lifestyle.~exercise: acute downhill running"
11287225|NCT02899650|EG002|Reported Event|Older Fit|"Older (50-80 yrs) people who have endurance training habit~exercise: acute downhill running"
11287226|NCT02899650|EG003|Reported Event|Older Unfit|"Older (50-80 yrs) people who have sedentary lifestyle~exercise: acute downhill running"
11287227|NCT02899689|BG000|Baseline|Foley Bulb Group|"Patients will have a Foley catheter inserted into the internal cervical os.~Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl."
11287228|NCT02899689|BG001|Baseline|Dilapan Group|"Patients will have Dilapan sticks inserted into the internal cervical os.~Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os."
11287229|NCT02899689|BG002|Baseline|Total|Total of all reporting groups
11287230|NCT02899689|FG000|Participant Flow|Foley Bulb Group|"Patients will have a Foley catheter inserted into the internal cervical os.~Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl."
11287231|NCT02899689|FG001|Participant Flow|Dilapan Group|"Patients will have Dilapan sticks inserted into the internal cervical os.~Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os."
11287232|NCT02899689|OG000|Outcome|Foley Bulb Group|"Patients will have a Foley catheter inserted into the internal cervical os.~Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl."
11287233|NCT02899689|OG001|Outcome|Dilapan Group|"Patients will have Dilapan sticks inserted into the internal cervical os.~Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os."
11287234|NCT02899689|EG000|Reported Event|Foley Bulb Group|"Patients will have a Foley catheter inserted into the internal cervical os.~Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl."
11287235|NCT02899689|EG001|Reported Event|Dilapan Group|"Patients will have Dilapan sticks inserted into the internal cervical os.~Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os."
11287236|NCT02899884|BG000|Baseline|Cohort 1|Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
11287237|NCT02899884|FG000|Participant Flow|Cohort 1|Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
11287238|NCT02899884|OG000|Outcome|Cohort 1|Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
11287239|NCT02899884|EG000|Reported Event|Cohort 1|Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
11287240|NCT02899962|BG000|Baseline|LEO 90100 Open-label Phase|LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily on the body for 4 weeks.
11287241|NCT02899962|FG000|Participant Flow|Open-label LEO 90100|In the open-label phase, LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily on the body for 4 weeks.
11287242|NCT02899962|FG001|Participant Flow|Maintenance LEO 90100|In the maintenance phase, subjects from open-label phase who achieved treatment success according to Physician's Global Assessment of disease severity (clear or almost clear with 2-step improvement) were randomised to receive LEO 90100 twice weekly for 52 weeks. In case of relapse (psoriasis which was mild, moderate or severe according to PGA), rescue medication was applied. Rescue medication was LEO 90100 applied once daily on the body for 4 weeks.
11287243|NCT02899962|FG002|Participant Flow|Maintenance Vehicle|In the maintenance phase, subjects from open-label phase who achieved treatment success according to Physician's Global Assessment of disease severity (clear or almost clear with 2-step improvement) were randomised to receive vehicle twice weekly for 52 weeks. In case of relapse (psoriasis which was mild, moderate or severe according to PGA), rescue medication was applied. Rescue medication was LEO 90100 applied once daily on the body for 4 weeks.
11287244|NCT02899962|OG000|Outcome|LEO 90100 Aerosol Foam|Topical application of LEO 90100 aerosol foam twice weekly for 52 weeks
11287245|NCT02899962|OG001|Outcome|LEO 90100 Aerosol Foam Vehicle|Topical application of LEO 90100 aerosol foam vehicle twice weekly for 52 weeks
11287246|NCT02899962|EG000|Reported Event|LEO 90100 Aerosol Foam Open-label|"Topical application once daily for 4 weeks~LEO 90100 aerosol foam open-label"
11287247|NCT02899962|EG001|Reported Event|LEO 90100 Aerosol Foam|"Topical application twice weekly for 52 weeks~LEO 90100 aerosol foam: LEO 90100 aerosol foam twice weekly"
11287248|NCT02899962|EG002|Reported Event|LEO 90100 Aerosol Foam Vehicle|"Topical application twice weekly for 52 weeks~LEO 90100 aerosol foam vehicle: LEO 90100 aerosol foam vehicle twice weekly"
11287249|NCT02899988|BG000|Baseline|Induction: Placebo|Induction: Placebo administered SC Q8W during Induction period.
11287250|NCT02899988|BG001|Baseline|Induction: 30 mg Mirikizumab|Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
11287251|NCT02899988|BG002|Baseline|Induction: 100 mg Mirikizumab|Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
11287252|NCT02899988|BG003|Baseline|Induction: 300 mg Mirikizumab|Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
11287253|NCT02899988|BG004|Baseline|Total|Total of all reporting groups
11287254|NCT02899988|FG000|Participant Flow|Induction: Placebo|Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.
11287255|NCT02899988|FG001|Participant Flow|Induction: 30 mg Mirikizumab Q8W|Induction: Participants received 30 milligram (mg) mirikizumab SC Q8W during Induction period.
11287256|NCT02899988|FG002|Participant Flow|Induction:100 mg Mirikizumab Q8W|Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
11287257|NCT02899988|FG003|Participant Flow|Induction: 300 mg Mirikizumab Q8W|Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
11287258|NCT02899988|FG004|Participant Flow|Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN|"Maintenance:~Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.~Participants who had greater than or equal to (≥) Psoriasis Area and Severity Index (PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.~Follow-up: participants did not receive drug during the follow-up period."
11287259|NCT02899988|FG005|Participant Flow|Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN|"Maintenance:~Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.~Follow-up: participants did not receive drug during the follow-up period."
11287260|NCT02899988|FG006|Participant Flow|Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN|"Maintenance:~Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.~Follow-up: participants did not receive drug during the follow-up period."
11287261|NCT02899988|FG007|Participant Flow|Maintenance: Placebo to 300 mg Mirikizumab Q8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.~Follow-up: Participants did not receive drug during the follow-up period."
11287262|NCT02899988|FG008|Participant Flow|Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had less than (<) PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.~Follow-up: Participants did not receive drug during the follow-up period."
11287263|NCT02899988|FG009|Participant Flow|Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.~Follow-up: participants did not receive drug during the follow-up period."
11287264|NCT02899988|FG010|Participant Flow|Maintenance: 300 mg Mirikizumab Q8W|"Maintenance:~Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period."
11287265|NCT02899988|OG000|Outcome|Induction: Placebo|Induction: Placebo administered SC Q8W during Induction period.
11287266|NCT02899988|OG001|Outcome|Induction: 30 mg Mirikizumab|Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
11287267|NCT02899988|OG002|Outcome|Induction: 100 mg Mirikizumab|Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
11287268|NCT02899988|OG003|Outcome|Induction: 300 mg Mirikizumab|Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
11287269|NCT02899988|OG002|Outcome|Induction: 100 mg Mirikizumab|Induction: 100 mg Mirikizumab administered SC Q8W during Induction period
11287270|NCT02899988|OG000|Outcome|30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN|"Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period."
11287271|NCT02899988|OG001|Outcome|100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN|"Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period."
11287272|NCT02899988|OG002|Outcome|300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN|"Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period."
11287273|NCT02899988|OG003|Outcome|Placebo to 300 mg Mirikizumab Q8W|"Participants received 300 mg mirikizumab Q8W during the maintenance period.~Participants had received placebo during induction period."
11287274|NCT02899988|OG004|Outcome|30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W|"Participants received 300 mg mirikizumab Q8W during the maintenance period.~Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period."
11287275|NCT02899988|OG005|Outcome|100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W|"Participants received 300 mg mirikizumab Q8W during the maintenance period.~Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period."
11287276|NCT02899988|OG006|Outcome|300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W|"Participants received 300 mg mirikizumab SC Q8W during Induction period.~Participants had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period."
11287277|NCT02899988|EG000|Reported Event|Induction: Placebo|Induction: Participants received placebo SC Q8W during Induction period.
11287278|NCT02899988|EG001|Reported Event|Induction: 30 mg Mirikizumab Q8W|Induction: Participants received 30 mg mirikizumab Q8W during Induction period.
11287279|NCT02899988|EG002|Reported Event|Induction:100 mg Mirikizumab Q8W|Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
11287280|NCT02899988|EG003|Reported Event|Induction: 300 mg Mirikizumab Q8W|Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
11287281|NCT02899988|EG004|Reported Event|Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN|"Maintenance:~Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.~Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period."
11287282|NCT02899988|EG005|Reported Event|Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN|"Maintenance:~Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period."
11287283|NCT02899988|EG006|Reported Event|Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN|"Maintenance:~Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.~Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period."
11287284|NCT02899988|EG007|Reported Event|Maintenance: Placebo to 300 mg Mirikizumab Q8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period."
11287285|NCT02899988|EG008|Reported Event|Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period."
11287286|NCT02899988|EG009|Reported Event|Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W|"Maintenance:~Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period."
11287287|NCT02899988|EG010|Reported Event|Maintenance: 300 mg Mirikizumab Q8W|"Maintenance:~Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period."
10842383|NCT00246337|BG001|Baseline|MK0974 25 mg|"MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
10842384|NCT00246337|BG002|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
11287288|NCT02899988|EG011|Reported Event|300 mg Mirikizumab Q8W-Rescue|Participants received 300 mg Q8W mirikizumab during rescue.
11287289|NCT02899988|EG012|Reported Event|30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287290|NCT02899988|EG013|Reported Event|100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287291|NCT02899988|EG014|Reported Event|300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287292|NCT02899988|EG015|Reported Event|Placebo to 300 mg Mirikizumab Q8W-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287293|NCT02899988|EG016|Reported Event|30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287294|NCT02899988|EG017|Reported Event|100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up|Follow-up: Participants did not receive drug during the follow-up period.
11287295|NCT02900092|BG000|Baseline|Ganaxolone Treatment Arm|Participants received ganaxolone
11287296|NCT02900092|FG000|Participant Flow|Ganaxolone Treatment Arm|Participants randomized to ganaxolone treatment
11287297|NCT02900092|OG000|Outcome|Ganaxolone Treatment Arm|Participants received ganaxolone
11287298|NCT02900092|EG000|Reported Event|Ganaxolone Treatment Arm|Participants received ganaxolone treatment
11287299|NCT02900170|BG000|Baseline|Participants|8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
11287300|NCT02900170|FG000|Participant Flow|Participants|8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
11287301|NCT02900170|OG000|Outcome|Participants|8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
11287302|NCT02900170|EG000|Reported Event|Participants|8 patients were enrolled in the study. Baseline creatinine and urinalysis was obtained.
11287303|NCT02900378|BG000|Baseline|LCZ696 (Sacubitril/Valsartan)|LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme.
11287304|NCT02900378|BG001|Baseline|Enalapril|Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme.
11287305|NCT02900378|BG002|Baseline|Total|Total of all reporting groups
10842385|NCT00246337|BG003|Baseline|MK0974 100 mg|"MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
10842386|NCT00246337|BG004|Baseline|MK0974 200 mg|"MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
10842387|NCT00246337|BG005|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
11287306|NCT02900378|FG000|Participant Flow|LCZ696 (Sacubitril/Valsartan)|LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme.
11287307|NCT02900378|FG001|Participant Flow|Enalapril|Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme.
11287308|NCT02900378|OG000|Outcome|LCZ696 (Sacubitril/Valsartan)|LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme.
11287309|NCT02900378|OG001|Outcome|Enalapril|Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme.
11287310|NCT02900378|EG000|Reported Event|LCZ696 (Sacubitril/Valsartan)|LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme.
11287311|NCT02900378|EG001|Reported Event|Enalapril|Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme.
11287312|NCT02901054|BG000|Baseline|Open Label Infusion Ondansetron|The entire cohort of subjects in this open-label study
11287313|NCT02901054|FG000|Participant Flow|Open Label Infusion Ondansetron|The full study cohort (open label, no treatment allocation)
11287314|NCT02901054|OG000|Outcome|Open Label Infusion Ondansetron|The full study cohort (open label, no treatment allocation)
11287315|NCT02901054|EG000|Reported Event|Open Label Infusion Ondansetron|The entire cohort of patients in this open-label study
11287316|NCT02901080|BG000|Baseline|Cranial Electrotherapy Stimulation|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee"
11332366|NCT03494725|OG000|Outcome|Lpc-37|"Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37~1x 1 capsule in the morning for 5 weeks~Lpc-37: Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide"
11333856|NCT03520920|FG002|Participant Flow|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R marginal zone lymphoma (MZL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11287317|NCT02901080|FG000|Participant Flow|Cranial Electrotherapy Stimulation|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)"
11287318|NCT02901080|OG000|Outcome|Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee"
11287319|NCT02901080|OG000|Outcome|Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)"
11287320|NCT02901080|OG000|Outcome|Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens(day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)"
11287321|NCT02901080|EG000|Reported Event|Cranial Electrotherapy Stimulation|"Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire~Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks.~Pregnancy test: - Pregnancy test (day 1)~Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24)~Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24)~Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24)~Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24)~Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)"
11287322|NCT02901249|BG000|Baseline|Sertraline|"Group Started: sertraline (50mg-200mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.~Second step: Sertraline 200mg + lithium (900mg-1500mg)~Non responsive patients: 3rd step.~Third step: Nortriptyline 100mg~Non responsive patients: 4th step.~Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg)~Non responsive patients : 5th step~Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients~sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)~sertraline~Nortriptyline~Lithium"
11287323|NCT02901249|FG000|Participant Flow|Sertraline|"Group Started: sertraline (50mg-200mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.~Second step: Sertraline 200mg + lithium (900mg-1500mg)~Non responsive patients: 3rd step.~Third step: Nortriptyline 100mg~Non responsive patients: 4th step.~Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg)~Non responsive patients : 5th step~Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients~sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)~sertraline~Nortriptyline~Lithium"
11336282|NCT03565068|FG007|Participant Flow|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg.
10842388|NCT00246337|BG006|Baseline|MK0974 400 mg|"MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
10842389|NCT00246337|BG007|Baseline|MK0974 600 mg|"MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
11287324|NCT02901249|OG000|Outcome|Sertraline|"Group Started: sertraline (50mg-200mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.~Second step: Sertraline 200mg + lithium (900mg-1500mg)~Non responsive patients: 3rd step.~Third step: Nortriptyline 100mg~Non responsive patients: 4th step.~Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg)~Non responsive patients : 5th step~Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients~sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)~sertraline~Nortriptyline~Lithium"
11287325|NCT02901249|EG000|Reported Event|Sertraline|"Group Started: sertraline (50mg-200mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.~Second step: Sertraline 200mg + lithium (900mg-1500mg)~Non responsive patients: 3rd step.~Third step: Nortriptyline 100mg~Non responsive patients: 4th step.~Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg)~Non responsive patients : 5th step~Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients~sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)~sertraline~Nortriptyline~Lithium"
11287326|NCT02901275|BG000|Baseline|All Participants|This is a within group study and same participants went through all treatment arms.
11287327|NCT02901275|FG000|Participant Flow|Full Participant Sample|"Each participant completed the following five study conditions (arms) in randomized order:~Placebo + Placebo condition~Hydromorphone (oral) 4mg + placebo condition~Hydromorphone (oral) 4mg + Dronabinol (oral) 2.5mg condition~Hydromorphone (oral) 4mg + Dronabinol (oral) 5mg condition~Hydromorphone (oral) 4mg + Dronabinol (oral) 10mg condition"
11287328|NCT02901275|OG000|Outcome|Placebo + Placebo Condition|Within-subject placebo + placebo control condition.
11287329|NCT02901275|OG001|Outcome|Hydromorphone (Oral) 4mg + Placebo Condition|Within-subject hydromorphone 4mg + placebo control condition.
11287330|NCT02901275|OG002|Outcome|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg|Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition
11287331|NCT02901275|OG003|Outcome|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg|Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition
11287332|NCT02901275|OG004|Outcome|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg|Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
10842390|NCT00246337|BG008|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
10842391|NCT00246337|BG009|Baseline|Total|Total of all reporting groups
10842392|NCT00246337|FG000|Participant Flow|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
11287333|NCT02901275|EG000|Reported Event|Placebo + Placebo Condition|Within-subject placebo + placebo control condition.
11287334|NCT02901275|EG001|Reported Event|Hydromorphone (Oral) 4mg + Placebo Condition|Within-subject hydromorphone 4mg + placebo control condition.
11287335|NCT02901275|EG002|Reported Event|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg|Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition
11287336|NCT02901275|EG003|Reported Event|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg|Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition
11287337|NCT02901275|EG004|Reported Event|Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg|Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
11287338|NCT02901431|BG000|Baseline|PK Part (Study Part 1) - Placebo|Participants received a matching placebo orally. Approximate treatment duration was up to 8 weeks.
11287339|NCT02901431|BG001|Baseline|PK Part (Study Part 1) - Balovaptan (RO5285119) 4 mg/d Equivalent|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287340|NCT02901431|BG002|Baseline|PK Part (Study Part 1) - Balovaptan (RO5285119) 10 mg/d Equivalent|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 mg/d of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287341|NCT02901431|BG003|Baseline|Main Study Part (Study Part 2) - Placebo|Participants in the Main Study Part received a matching placebo orally. Approximate treatment duration was up to 24 weeks.
11287342|NCT02901431|BG004|Baseline|Main Study Part (Study Part 2) - Low Exposure Tertile|Participants in the Main Study Part in the Low Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287343|NCT02901431|BG005|Baseline|Main Study Part (Study Part 2) - Medium Exposure Tertile|Participants in the Main Study Part in the Medium Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287344|NCT02901431|BG006|Baseline|Main Study Part (Study Part 2) - High Exposure Tertile|Participants in the Main Study Part in the High Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287345|NCT02901431|BG007|Baseline|Main Study Part (Study Part 2) - Dose-Adjusters|Participants with dose adjustment who were excluded from the analysis by tertiles. Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287346|NCT02901431|BG008|Baseline|Total|Total of all reporting groups
11287347|NCT02901431|FG000|Participant Flow|PK Part - Placebo|Participants received a matching placebo orally. Approximate treatment duration was up to 8 weeks.
11336283|NCT03565068|FG008|Participant Flow|Panel D (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15.
11287348|NCT02901431|FG001|Participant Flow|PK Part - Balovaptan (RO5285119) 4 mg/d Equivalent|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287349|NCT02901431|FG002|Participant Flow|PK Part - Balovaptan (RO5285119) 10 mg/d Equivalent|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287350|NCT02901431|FG003|Participant Flow|Main Study Part - Placebo|Participants received a matching placebo orally. Approximate treatment duration was up to 24 weeks in Main Study Part.
11287351|NCT02901431|FG004|Participant Flow|Main Study Part - Low Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287352|NCT02901431|FG005|Participant Flow|Main Study Part - Medium Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287353|NCT02901431|FG006|Participant Flow|Main Study Part - High Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287354|NCT02901431|FG007|Participant Flow|Main Study Part - Dose Adjusters|Participants with dose adjustment who were excluded from the analysis by tertiles. Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287355|NCT02901431|FG008|Participant Flow|Open Label Extension Part - Placebo|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287356|NCT02901431|FG009|Participant Flow|Open Label Extension Part - Low Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287357|NCT02901431|FG010|Participant Flow|Open Label Extension Part - Medium Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287358|NCT02901431|FG011|Participant Flow|Open Label Extension Part - High Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287359|NCT02901431|FG012|Participant Flow|Open Label Extension Part - Dose-Adjusters|Participants with dose adjustment who were excluded from the analysis by tertiles. Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287360|NCT02901431|OG000|Outcome|Placebo|Participants received a matching placebo orally. Approximate treatment duration was up to 24 weeks.
11287361|NCT02901431|OG001|Outcome|Balovaptan (RO5285119) 10 mg/d Equivalent|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287362|NCT02901431|OG000|Outcome|Main Study Part, Low Exposure Tertile|Participants in the Main Study Part in the Low Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287363|NCT02901431|OG001|Outcome|Main Study Part, Medium Exposure Tertile|Participants in the Main Study Part in the Medium Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287364|NCT02901431|OG002|Outcome|Main Study Part, High Exposure Tertile|Participants in the Main Study Part in the High Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287365|NCT02901431|OG003|Outcome|Main Study Part (Study Part 2) - All Treated|All participants in the Main Study Part received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). This group includes participants from the low, medium, and high exposure tertiles, as well as the Dose-Adjusters. Approximate treatment duration was up to 24 weeks.
11287366|NCT02901431|OG004|Outcome|Open Label Extension Part, Low Exposure Tertile|Participants in the Open Label Extension Part of the study in the Low Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks.
11287367|NCT02901431|OG005|Outcome|Open Label Extension Part, Medium Exposure Tertile|Participants in the Open Label Extension Part of the study in the Medium Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287368|NCT02901431|OG006|Outcome|Open Label Extension Part, High Exposure Tertile|Participants in the Open Label Extension Part of the study in the High Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up 52 weeks.
11333857|NCT03520920|OG000|Outcome|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11287369|NCT02901431|OG007|Outcome|Open Label Extension Part, All Treated|All participants in the Open Label Extension Part of the study received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). This group includes participants from the low, medium, and high exposure tertiles, as well as the Dose-Adjusters. Approximate treatment duration was up to 52 weeks.
11287370|NCT02901431|EG000|Reported Event|PK Part (Study Part 1) - Placebo|Participants in the PK Part of the study who received a matching placebo orally. Approximate treatment duration was up to 8 weeks.
11287371|NCT02901431|EG001|Reported Event|PK Part (Study Part 1) - Balovaptan (RO5285119) 4 mg/d Equivalent|Participants in the PK Part of the study who received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287372|NCT02901431|EG002|Reported Event|PK Part (Study Part 1) - Balovaptan (RO5285119) 10 mg/d Equivalent|Participants in the PK Part of the study who received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 8 weeks.
11287373|NCT02901431|EG003|Reported Event|Main Study Part (Study Part 2) - Placebo|Participants in the Main Study Part received a matching placebo orally. Approximate treatment duration was up to 24 weeks.
11287374|NCT02901431|EG004|Reported Event|Main Study Part (Study Part 2) - Low Exposure Tertile|Participants in the Main Study Part in the Low Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287375|NCT02901431|EG005|Reported Event|Main Study Part (Study Part 2) - Medium Exposure Tertile|Participants in the Main Study Part in the Medium Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287376|NCT02901431|EG006|Reported Event|Main Study Part (Study Part 2) - High Exposure Tertile|Participants in the Main Study Part in the High Exposure Tertile received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks.
11287377|NCT02901431|EG007|Reported Event|Main Study Part (Study Part 2) - Dose-Adjusters|Participants with dose adjustment who were excluded from the analysis by tertiles. Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 4 or 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks in Main Study Part.
11287378|NCT02901431|EG008|Reported Event|Open Label Extension Part (Study Part 3) - Placebo|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287379|NCT02901431|EG009|Reported Event|Open Label Extension Part (Study Part 3) - Low Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287380|NCT02901431|EG010|Reported Event|Open Label Extension Part (Study Part 3) - Medium Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
10842393|NCT00246337|FG001|Participant Flow|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287381|NCT02901431|EG011|Reported Event|Open Label Extension Part (Study Part 3) - High Exposure Tertile|Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287382|NCT02901431|EG012|Reported Event|Open Label Extension Part (Study Part 3) - Dose-Adjusters|Participants with dose adjustment who were excluded from the analysis by tertiles. Participants received age-adjusted total daily oral dose approximately equivalent to the adult dose of 10 milligrams per day (mg/d) of balovaptan (RO5285119). Approximate treatment duration was up to 52 weeks in Open Label Extension Part.
11287383|NCT02901899|BG000|Baseline|Treatment (Guadecitabine, Pembrolizumab)|Patients receive guadecitabine as a subcutaneous injection on Days 1-4 and pembrolizumab as a IV infusion over 30 minutes on Day 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11287384|NCT02901899|FG000|Participant Flow|Treatment (Guadecitabine, Pembrolizumab)|Patients receive guadecitabine as a subcutaneous injection on Days 1-4 and pembrolizumab as a IV infusion over 30 minutes on Day 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11287385|NCT02901899|OG000|Outcome|Treatment (Guadecitabine, Pembrolizumab)|Patients receive guadecitabine as a subcutaneous injection on Days 1-4 and pembrolizumab as a IV infusion over 30 minutes on Day 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11287386|NCT02901899|EG000|Reported Event|Treatment (Guadecitabine, Pembrolizumab)|Patients receive guadecitabine as a subcutaneous injection on Days 1-4 and pembrolizumab as a IV infusion over 30 minutes on Day 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11287387|NCT02901951|BG000|Baseline|HBV Group|Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
11287388|NCT02901951|FG000|Participant Flow|HBV Group|Subjects aged 40 to 60 years old who received 3 or 4 doses of Engerix-B (HBV vaccine) 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
11287389|NCT02901951|OG000|Outcome|HBV Group|Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
11287390|NCT02901951|EG000|Reported Event|HBV Group|Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
11287391|NCT02902081|BG000|Baseline|ALL Study Participants|"This is a within-subjects study design in which all participants received all three does (300, 600, and 900 mg oral) of cannabidol and a placebo in randomized order."
11287392|NCT02902081|FG000|Participant Flow|ALL Study Participants|"This is a within-subjects study design in which all participants received all three does (300, 600, and 900 mg oral) of cannabidol and a placebo in randomized order."
11287393|NCT02902081|OG000|Outcome|Placebo|Placebo capsule administered once prior to subjective drug effects questionnaires and behavioral tasks.
11287394|NCT02902081|OG001|Outcome|300 mg Cannabidiol|(300 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
11287395|NCT02902081|OG002|Outcome|600 mg Cannabidiol|(600 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
11287396|NCT02902081|OG003|Outcome|900 mg Cannabidiol|(900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
11287397|NCT02902081|EG000|Reported Event|Placebo|"Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.~Placebo"
11287398|NCT02902081|EG001|Reported Event|Cannabidiol|(300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
11287399|NCT02902146|BG000|Baseline|Bougie|"On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.~Bougie"
11287400|NCT02902146|BG001|Baseline|No Bougie (Endotracheal Tube First)|"On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.~Endotracheal tube"
11287401|NCT02902146|BG002|Baseline|Total|Total of all reporting groups
11287402|NCT02902146|FG000|Participant Flow|Bougie|"On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.~Bougie"
11287403|NCT02902146|FG001|Participant Flow|No Bougie (Endotracheal Tube First)|"On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.~Endotracheal tube"
11287404|NCT02902146|OG000|Outcome|Bougie|"On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.~Bougie"
11287405|NCT02902146|OG001|Outcome|No Bougie (Endotracheal Tube First)|"On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.~Endotracheal tube"
11287406|NCT02902146|EG000|Reported Event|Bougie|"On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.~Bougie"
11287407|NCT02902146|EG001|Reported Event|No Bougie (Endotracheal Tube First)|"On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.~Endotracheal tube"
11287408|NCT02902172|BG000|Baseline|Acetaminophen|Women receiving acetaminophen for primary pain control following vaginal delivery.
11287409|NCT02902172|BG001|Baseline|NSAID|Women receiving Ibuprofen for primary pain control following vaginal delivery.
11287410|NCT02902172|BG002|Baseline|Total|Total of all reporting groups
11287411|NCT02902172|FG000|Participant Flow|Acetaminophen|Women receiving acetaminophen for primary pain control following vaginal delivery.
11287412|NCT02902172|FG001|Participant Flow|NSAID|Women receiving Ibuprofen for primary pain control following vaginal delivery.
11287413|NCT02902172|OG000|Outcome|Acetaminophen|"Patients will be monitored for change in blood pressure~Acetaminophen: Blood pressure will be monitored during postpartum stay (typical 2 days)"
11287414|NCT02902172|OG001|Outcome|NSAID|"Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week~NSAID: Blood pressure will be monitored during postpartum stay (typical 2 days)"
11287415|NCT02902172|OG001|Outcome|NSAID|"Patients will be monitored during their postpartum stay (typical 2 days)~NSAID: Blood pressure will be monitored during postpartum stay (typical 2 days)"
11287416|NCT02902172|EG000|Reported Event|Acetaminophen|Women receiving acetaminophen for primary pain control following vaginal delivery.
11287417|NCT02902172|EG001|Reported Event|NSAID|Women receiving Ibuprofen for primary pain control following vaginal delivery.
11287418|NCT02902237|BG000|Baseline|tTF-NGR|This was a single-arm, mono-center, open-label trial. tTF-NGR was given as a 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks to all 17 patients treated. 8 patients received 2 cycles, 1 patient received 3 cycles, and 8 patients received 1 cycle.
11287419|NCT02902237|FG000|Participant Flow|tTF-NGR|tTF-NGR will be given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks and following cycles with dose escalation of 0.5 mg/m2 upon judgement of tolerability and therapeutic activity. Starting dose will be 1 mg/m2/day. Dose-escalation is stopped before the maximum number of 8 escalation steps if tumor response, tumor progression or a Dose-Limiting Toxicity (DLT) is observed.
11287420|NCT02902237|OG000|Outcome|tTF-NGR|All 17 patients obtaining at least 1 dose of tTF-NGR were analysed for MTD and DLT.
11287421|NCT02902237|OG000|Outcome|tTF-NGR|All 17 patients obtaining at least 1 dose of tTF-NGR were analysed for safety and efficacy. All 17 patients were assayed for tTF-NGR pharmacokinetics.
11287422|NCT02902237|EG000|Reported Event|tTF-NGR Dose: 1,0 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287423|NCT02902237|EG001|Reported Event|tTF-NGR Dose: 1,5 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287424|NCT02902237|EG002|Reported Event|tTF-NGR Dose: 2,0 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287425|NCT02902237|EG003|Reported Event|tTF-NGR Dose: 2,5 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287426|NCT02902237|EG004|Reported Event|tTF-NGR Dose: 3,0 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287427|NCT02902237|EG005|Reported Event|tTF-NGR Dose: 4,0 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
10822124|NCT00074581|OG000|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
11287428|NCT02902237|EG006|Reported Event|tTF-NGR Dose: 5,0 mg/m^2|tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
11287429|NCT02902770|BG000|Baseline|Lidocaine and Normal Saline Push|"1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Normal Saline Push: Normal Saline Push Placebo"
11287430|NCT02902770|BG001|Baseline|Ketorolac and Normal Saline Drip|"IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip~Ketorolac Tromethamine: IV ketorolac 30mg push~Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes"
11287431|NCT02902770|BG002|Baseline|Lidocaine and Ketorolac|"IV Lidocaine Drip and IV Ketorolac Push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Ketorolac Tromethamine: IV ketorolac 30mg push"
11287432|NCT02902770|BG003|Baseline|Total|Total of all reporting groups
11287433|NCT02902770|FG000|Participant Flow|Lidocaine and Normal Saline Push|"1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Normal Saline Push: Normal Saline Push Placebo"
11287434|NCT02902770|FG001|Participant Flow|Ketorolac and Normal Saline Drip|"IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip~Ketorolac Tromethamine: IV ketorolac 30mg push~Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes"
11287435|NCT02902770|FG002|Participant Flow|Lidocaine and Ketorolac|"IV Lidocaine Drip and IV Ketorolac Push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Ketorolac Tromethamine: IV ketorolac 30mg push"
11287436|NCT02902770|OG000|Outcome|Lidocaine and Normal Saline Push|"1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Normal Saline Push: Normal Saline Push Placebo"
11287437|NCT02902770|OG001|Outcome|Ketorolac and Normal Saline Drip|"IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip~Ketorolac Tromethamine: IV ketorolac 30mg push~Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes"
11287438|NCT02902770|OG002|Outcome|Lidocaine and Ketorolac|"IV Lidocaine Drip and IV Ketorolac Push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Ketorolac Tromethamine: IV ketorolac 30mg push"
11287439|NCT02902770|EG000|Reported Event|Lidocaine and Normal Saline Push|"1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Normal Saline Push: Normal Saline Push Placebo"
11287440|NCT02902770|EG001|Reported Event|Ketorolac and Normal Saline Drip|"IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip~Ketorolac Tromethamine: IV ketorolac 30mg push~Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes"
11287441|NCT02902770|EG002|Reported Event|Lidocaine and Ketorolac|"IV Lidocaine Drip and IV Ketorolac Push~Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes)~Ketorolac Tromethamine: IV ketorolac 30mg push"
11287442|NCT02902809|BG000|Baseline|Tralokinumab 300 mg Every 2 Weeks (Q2W)|Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
11287443|NCT02902809|FG000|Participant Flow|Tralokinumab 300 mg Every 2 Weeks (Q2W)|Participants were administered with tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks for 52 weeks.
11287444|NCT02902809|OG000|Outcome|Tralokinumab 300 mg Every 2 Weeks (Q2W)|Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
11287445|NCT02902809|EG000|Reported Event|Tralokinumab 300 mg Every 2 Weeks (Q2W)|Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
11287446|NCT02902913|BG000|Baseline|All Participants|"All participants received all four study interventions. The first three interventions were administered in random order:~Oleocanthal-rich, D2i2~Oleacein-rich, D2i0.5~Oleocanthal and Oleacein-low, D2i0~All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit."
11287447|NCT02902913|FG000|Participant Flow|All Participants|"All participants received all four study interventions. The first three interventions were administered in random order:~Oleocanthal-rich, D2i2~Oleacein-rich, D2i0.5~Oleocanthal and Oleacein-low, D2i0~All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit."
11287448|NCT02902913|OG000|Outcome|All Participants|"All participants received all four study interventions. The first three interventions were administered in random order:~Oleocanthal-rich, D2i2~Oleacein-rich, D2i0.5~Oleocanthal and Oleacein-low, D2i0~All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit."
11287449|NCT02902913|OG000|Outcome|Oleocanthal-rich, D2i2|"Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)~D2i2: Oleocanthal provided in a 2:1 ratio compared to oleacein"
11287450|NCT02902913|OG001|Outcome|Oleacein-rich, D2i0.5|"Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)~D2i0.5: Oleocanthal provided in a 1:2 ratio compared to oleacein"
11287451|NCT02902913|OG002|Outcome|Oleocanthal and Oleacein-low, D2i0|"Oleocanthal and Oleacein-low, D2i0 (Extra virgin olive oil containing low amounts of oleocanthal to oleacein, but with a similar total phenolic content as the other two oils)~D2i0: No oleocanthal and no oleacein"
11287452|NCT02902913|OG003|Outcome|Ibuprofen|"Ibuprofen, 400 mg~Ibuprofen: 400 mg of Ibuprofen"
11287453|NCT02902913|EG000|Reported Event|All Participants|"All participants received all four study interventions. The first three interventions were administered in random order:~Oleocanthal-rich, D2i2~Oleacein-rich, D2i0.5~Oleocanthal and Oleacein-low, D2i0~All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit."
11287454|NCT02902965|BG000|Baseline|Ibrutinib+ Bortezomib+ Dexamethasone|"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone(D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects >75 years of age.~Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter."
11287455|NCT02902965|FG000|Participant Flow|Ibrutinib+ Bortezomib+ Dexamethasone|"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects >75 years of age.~Following implementation of Protocol Amendment4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter"
11287456|NCT02902965|OG000|Outcome|Ibrutinib+ Bortezomib+ Dexamethasone|"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects >75 years of age.~Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter"
11287457|NCT02902965|OG000|Outcome|Ibrutinib+ Bortezomib+ Dexamethasone|"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects >75 years of age.~Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter."
11332367|NCT03494725|OG000|Outcome|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37~Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
10842394|NCT00246337|FG002|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842395|NCT00246337|FG003|Participant Flow|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287458|NCT02902965|EG000|Reported Event|Ibrutinib+ Bortezomib+ Dexamethasone|"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects >75 years of age.~Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter."
11287459|NCT02903030|BG000|Baseline|Visbiome, Then Placebo|"Participants were randomly assigned 1:1 to Visbiome probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose: the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.~Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety"
11287460|NCT02903030|BG001|Baseline|Placebo, the Visbiome|"Particiapants were randomly assigned 1:1 to placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose: the first 4 weeks of the probiotic treatment was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~Placebo matched to probiotic.~Maltose (placebo): Maltose with a trace amount of silicon dioxide"
11287461|NCT02903030|BG002|Baseline|Total|Total of all reporting groups
11287462|NCT02903030|FG000|Participant Flow|Visbiome, Then Placebo|"Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to probiotic Visbiome for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).~The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.~Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety"
11287463|NCT02903030|FG001|Participant Flow|Placebo, Then Visbiome|"Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).~Placebo matched to probiotic.~Maltose (placebo): Maltose with a trace amount of silicon dioxide"
11287464|NCT02903030|OG000|Outcome|Visbiome|"Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.~Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety"
11287465|NCT02903030|OG001|Outcome|Placebo|"Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~Placebo matched to probiotic.~Maltose (placebo): Maltose with a trace amount of silicon dioxide"
11287466|NCT02903030|OG000|Outcome|Visbiome|"The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.~Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety"
11287467|NCT02903030|OG001|Outcome|Placebo|"Placebo matched to probiotic.~Maltose (placebo): Maltose with a trace amount of silicon dioxide"
11287468|NCT02903030|OG001|Outcome|Placebo|Placebo matched to probiotic. Maltose (placebo): Maltose with a trace amount of silicon dioxide
11287469|NCT02903030|EG000|Reported Event|Visbiome|"Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.~Visbiome Extra Strength: A mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety"
11287470|NCT02903030|EG001|Reported Event|Placebo|"Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.~Placebo matched to probiotic.~Maltose (placebo): Maltose with a trace amount of silicon dioxide"
11287471|NCT02903121|BG000|Baseline|Tamoxifen|"Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study~Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study"
11287472|NCT02903121|BG001|Baseline|Placebo|"Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study"
11287473|NCT02903121|BG002|Baseline|Total|Total of all reporting groups
10842396|NCT00246337|FG004|Participant Flow|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287474|NCT02903121|FG000|Participant Flow|Tamoxifen|"Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study~Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study"
11287475|NCT02903121|FG001|Participant Flow|Placebo|"Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study"
11287476|NCT02903121|OG000|Outcome|Tamoxifen|"Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study~Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study"
11287477|NCT02903121|OG001|Outcome|Placebo|"Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study"
11287478|NCT02903121|EG000|Reported Event|Tamoxifen|"Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study~Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study"
11287479|NCT02903121|EG001|Reported Event|Placebo|"Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding~Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study"
11287480|NCT02903238|BG000|Baseline|Placebo|"placebo capsule~placebo: lactose containing capsule"
11287481|NCT02903238|FG000|Participant Flow|Placebo|"placebo capsule~placebo: lactose containing capsule"
11287482|NCT02903238|OG000|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
11287483|NCT02903238|OG001|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
11287484|NCT02903238|EG000|Reported Event|Placebo|"placebo capsule~placebo: lactose containing capsule"
11287485|NCT02903368|BG000|Baseline|Arm 1A: AAPL Neoadjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months"
11287486|NCT02903368|BG001|Baseline|Arm 1B: APL Adjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287487|NCT02903368|BG002|Baseline|Total|Total of all reporting groups
11287488|NCT02903368|FG000|Participant Flow|Arm 1A: AAPL Neoadjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months~consistent"
11287489|NCT02903368|FG001|Participant Flow|Arm 1B: APL Adjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287490|NCT02903368|OG000|Outcome|Arm A: AAPL|"Eligible Participants will be randomized to receive:~AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months"
11287491|NCT02903368|OG001|Outcome|Arm B: APL|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287492|NCT02903368|OG000|Outcome|Arm 1A: AAPL Neoadjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months"
11287493|NCT02903368|OG001|Outcome|Arm 1B: APL Adjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287494|NCT02903368|OG001|Outcome|Arm B: APL Adjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287495|NCT02903368|EG000|Reported Event|Arm 1A: AAPL Neoadjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months"
11287496|NCT02903368|EG001|Reported Event|Arm 1B: APL Adjuvant Therapy (Part 1)|"Eligible Participants will be randomized to receive:~APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months"
11287497|NCT02903394|BG000|Baseline|mLCI Imaging (Pilot)|Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
11287498|NCT02903394|BG001|Baseline|mLCI Imaging (Jacobi)|"Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.~Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type."
11287499|NCT02903394|BG002|Baseline|Total|Total of all reporting groups
11287500|NCT02903394|FG000|Participant Flow|mLCI Imaging (Pilot)|Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
11287501|NCT02903394|FG001|Participant Flow|mLCI Imaging (Jacobi)|"Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.~Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type."
11287502|NCT02903394|OG000|Outcome|mLCI Imaging (Pilot)|Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
11287503|NCT02903394|OG001|Outcome|mLCI Imaging (Jacobi)|"Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.~Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type."
11287504|NCT02903394|OG000|Outcome|mLCI Imaging (Pilot)|Pilot study. 5 women from ages 24 to 34recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
11287505|NCT02903394|EG000|Reported Event|mLCI Imaging (Pilot)|Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
11287506|NCT02903394|EG001|Reported Event|mLCI Imaging (Jacobi)|"Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.~Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type."
10842397|NCT00246337|FG005|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287507|NCT02903407|BG000|Baseline|Midazolam|"IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11332368|NCT03494725|OG001|Outcome|Placebo|"Placebo: capsule manufactured to mimic Lpc-37 capsule~Ingredients: microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11333858|NCT03520920|OG001|Outcome|Relapsed/Refractory Follicular Lymphoma|Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
10842398|NCT00246337|FG006|Participant Flow|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287508|NCT02903407|BG001|Baseline|Propofol or Dexmedetomidine|"Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.~Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287509|NCT02903407|BG002|Baseline|Total|Total of all reporting groups
11287510|NCT02903407|FG000|Participant Flow|Midazolam|"IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287511|NCT02903407|FG001|Participant Flow|Propofol or Dexmedetomidine|"Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.~Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287512|NCT02903407|OG000|Outcome|Midazolam|"IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287513|NCT02903407|OG001|Outcome|Propofol or Dexmedetomidine|"Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.~Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287514|NCT02903407|EG000|Reported Event|Midazolam|"IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287515|NCT02903407|EG001|Reported Event|Propofol or Dexmedetomidine|"Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.~Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.~Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2."
11287516|NCT02903420|BG000|Baseline|SAPIEN 3|"Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System~Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach."
11287517|NCT02903420|FG000|Participant Flow|SAPIEN 3|"Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System~Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach."
11287518|NCT02903420|OG000|Outcome|SAPIEN 3|"Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System~Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach."
11287519|NCT02903420|EG000|Reported Event|SAPIEN 3|"Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System~Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach."
11287520|NCT02903446|BG000|Baseline|Intervention|"Denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + urate lowering therapy (ULT) standard of care~Denosumab: Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy"
11287521|NCT02903446|BG001|Baseline|Control|Standard urate lowering therapy
11287522|NCT02903446|BG002|Baseline|Total|Total of all reporting groups
11287523|NCT02903446|FG000|Participant Flow|Intervention|"Denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + urate lowering therapy (ULT) standard of care~Denosumab: Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy"
11287524|NCT02903446|FG001|Participant Flow|Control|Standard urate lowering therapy
11287525|NCT02903446|OG000|Outcome|Intervention|"Denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + urate lowering therapy (ULT) standard of care~Denosumab: Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy"
11287526|NCT02903446|OG001|Outcome|Control|Standard urate lowering therapy
11287527|NCT02903446|EG000|Reported Event|Intervention|"Denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + urate lowering therapy (ULT) standard of care~Denosumab: Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy"
11287528|NCT02903446|EG001|Reported Event|Control|Standard urate lowering therapy
11287529|NCT02903511|BG000|Baseline|Metformin|"Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Metformin: Monitoring of safety and tolerability"
11287530|NCT02903511|BG001|Baseline|Placebo|"Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Placebo: Monitoring of safety and tolerability"
11287531|NCT02903511|BG002|Baseline|Total|Total of all reporting groups
11287532|NCT02903511|FG000|Participant Flow|Metformin|"Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Metformin: Monitoring of safety and tolerability"
11287533|NCT02903511|FG001|Participant Flow|Placebo|"Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Placebo: Monitoring of safety and tolerability"
10970625|NCT00911300|EG000|Reported Event|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
11287534|NCT02903511|OG000|Outcome|Metformin|"Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Metformin: Monitoring of safety and tolerability"
11287535|NCT02903511|OG001|Outcome|Placebo|"Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Placebo: Monitoring of safety and tolerability"
11287536|NCT02903511|EG000|Reported Event|Metformin|"Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Metformin: Monitoring of safety and tolerability"
11287537|NCT02903511|EG001|Reported Event|Placebo|"Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.~Placebo: Monitoring of safety and tolerability"
11287538|NCT02903836|BG000|Baseline|Nafithromycin 800 mg 3 Days|"PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind~Nafithromycin 800 mg 3 days"
11287539|NCT02903836|BG001|Baseline|Nafithromycin 800 mg 5 Days|"PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind~Nafithromycin 800 mg 5 days"
11287540|NCT02903836|BG002|Baseline|Moxifloxacin 400 mg 7 Days|"PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind~Moxifloxacin 400 mg 7 days"
11287541|NCT02903836|BG003|Baseline|Total|Total of all reporting groups
11287542|NCT02903836|FG000|Participant Flow|Nafithromycin 800 mg 3 Days|"PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind~Nafithromycin 800 mg 3 days"
11287543|NCT02903836|FG001|Participant Flow|Nafithromycin 800 mg 5 Days|"PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind~Nafithromycin 800 mg 5 days"
11287544|NCT02903836|FG002|Participant Flow|Moxifloxacin 400 mg|"PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind~Moxifloxacin 400 mg"
11287545|NCT02903836|OG000|Outcome|Nafithromycin 800 mg 3 Days|"PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind~Nafithromycin 800 mg 3 days"
11287546|NCT02903836|OG001|Outcome|Nafithromycin 800 mg 5 Days|"PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind~Nafithromycin 800 mg 5 days"
11287547|NCT02903836|OG002|Outcome|Moxifloxacin 400 mg|"PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind~Moxifloxacin 400 mg"
11287548|NCT02903836|EG000|Reported Event|Nafithromycin 800 mg 3 Days|"PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind~Nafithromycin 800 mg 3 days"
11287549|NCT02903836|EG001|Reported Event|Nafithromycin 800 mg 5 Days|"PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind~Nafithromycin 800 mg 5 days"
11287550|NCT02903836|EG002|Reported Event|Moxifloxacin 400 mg 7 Days|"PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind~Moxifloxacin 400 mg 7 days"
11287551|NCT02903966|BG000|Baseline|Placebo TID DB /GSK2982772 60 mg TID OL|Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.
11287552|NCT02903966|BG001|Baseline|GSK2982772 60 mg TID DB/ GSK2982772 60 mg TID OL|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the pharmacokinetic (PK) profile is comparable for BID & TID regimen.
11287553|NCT02903966|BG002|Baseline|Total|Total of all reporting groups
11287554|NCT02903966|FG000|Participant Flow|Placebo TID DB /GSK2982772 60 mg TID OL|Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.
11287555|NCT02903966|FG001|Participant Flow|GSK2982772 60 mg TID DB/ GSK2982772 60 mg TID OL|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the pharmacokinetic (PK) profile is comparable for BID & TID regimen.
11287556|NCT02903966|OG000|Outcome|Part A: Placebo TID DB|Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).
11287557|NCT02903966|OG001|Outcome|Part A: GSK2982772 60 mg TID DB|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
11287558|NCT02903966|OG000|Outcome|Part B: GSK2982772 60 mg TID OL|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part B (open label phase).
11287559|NCT02903966|OG000|Outcome|Placebo TID DB /GSK2982772 60 mg TID OL|Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.
11287560|NCT02903966|OG001|Outcome|GSK2982772 60 mg TID DB /GSK2982772 60 mg TID OL|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the PK profile is comparable for BID & TID regimen
11287561|NCT02903966|OG000|Outcome|Part A: Placebo TID DB|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
11287562|NCT02903966|OG000|Outcome|Part A: GSK2982772 60 mg TID DB|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
11287563|NCT02903966|EG000|Reported Event|Part A: Placebo TID DB|Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).
11287564|NCT02903966|EG001|Reported Event|Part A: GSK2982772 60 mg TID DB|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
11287565|NCT02903966|EG002|Reported Event|Part B: GSK2982772 60 mg TID OL|Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part B (open label phase).
11287566|NCT02904057|BG000|Baseline|Treatment Group: Radiesse (+) Injectable Implant|Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).
11287567|NCT02904057|BG001|Baseline|Control Group: Untreated|Participants did not receive jawline treatment.
11287568|NCT02904057|BG002|Baseline|Total|Total of all reporting groups
11287569|NCT02904057|FG000|Participant Flow|Treatment Group: Radiesse (+) Injectable Implant|Participants received Radiesse+Lidocaine Injectable Implant up to 3.0 cubic centimeter (cc) volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).
11287570|NCT02904057|FG001|Participant Flow|Control Group: Untreated|Participants did not receive jawline treatment.
11287571|NCT02904057|OG000|Outcome|Treatment Group: Radiesse (+) Injectable Implant|Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).
11287572|NCT02904057|OG001|Outcome|Control Group: Untreated|Participants did not receive jawline treatment.
11287573|NCT02904057|EG000|Reported Event|Treatment Group: Radiesse (+) Injectable Implant|Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline).
11287574|NCT02904057|EG001|Reported Event|Control Group: Untreated|Participants did not receive jawline treatment.
11287575|NCT02904096|BG000|Baseline|Group A: MHGS Grade 4 Hands Group|Subjects with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.
11287576|NCT02904096|BG001|Baseline|Group B: MHGS Grade 2 or 3 Hands Group|Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
11287577|NCT02904096|BG002|Baseline|Total|Total of all reporting groups
11287578|NCT02904096|FG000|Participant Flow|Group A: MHGS Grade 4 Hands Group|Subjects with Merz hand grading scale (MHGS) Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2 percent (%) lidocaine hydrochloric acid (HCL) up to 3 cubic centimeter (cc) (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.
11287579|NCT02904096|FG001|Participant Flow|Group B: MHGS Grade 2 or 3 Hands Group|Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
11287580|NCT02904096|OG000|Outcome|Group A: MHGS Grade 4 Hands Group|Subjects with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.
11287581|NCT02904096|OG001|Outcome|Group B: MHGS Grade 2 or 3 Hands Group|Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
11287582|NCT02904096|EG000|Reported Event|Group A: MHGS Grade 4 Hands Group|Subjects with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.
11287583|NCT02904096|EG001|Reported Event|Group B: MHGS Grade 2 or 3 Hands Group|Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
11287584|NCT02904200|BG000|Baseline|Avance® Film With Safetac®|"Sterile soft silicon adhesive dressing~Silicon adhesive dressing: Sterile soft silicon adhesive dressing"
10822125|NCT00074581|OG001|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
10822126|NCT00074581|EG000|Reported Event|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
10822127|NCT00074581|EG001|Reported Event|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
10822128|NCT00074711|BG000|Baseline|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
10822129|NCT00074711|BG001|Baseline|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
11287585|NCT02904200|FG000|Participant Flow|Avance® Film With Safetac®|"Sterile soft silicon adhesive dressing~Silicon adhesive dressing: Sterile soft silicon adhesive dressing"
11287586|NCT02904200|FG001|Participant Flow|Avance® Transparent Film|"Sterile acrylic adhesive dressing~Acrylic adhesive dressing: Sterile acrylic adhesive dressing"
11287587|NCT02904200|OG000|Outcome|Avance® Film With Safetac®|"Sterile soft silicon adhesive dressing~Silicon adhesive dressing: Sterile soft silicon adhesive dressing"
11287588|NCT02904200|EG000|Reported Event|Avance® Film With Safetac®|"Sterile soft silicon adhesive dressing~Silicon adhesive dressing: Sterile soft silicon adhesive dressing"
11287589|NCT02904226|BG000|Baseline|Part A (JTX-2011)|"Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion~JTX-2011: Specified dose on specified days"
11287590|NCT02904226|BG001|Baseline|Part B (JTX-2011 + Nivolumab)|"Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287591|NCT02904226|BG002|Baseline|Part C (JTX-2011)|"Phase 2 expansion of JTX-2011 by IV infusion~JTX-2011: Specified dose on specified days"
11287592|NCT02904226|BG003|Baseline|Part D (JTX-2011 + Nivolumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287593|NCT02904226|BG004|Baseline|Part E (JTX-2011 + Ipilimumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287594|NCT02904226|BG005|Baseline|Part F (JTX-2011 + Ipilimumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287595|NCT02904226|BG006|Baseline|Part G (JTX-2011 + Pembrolizumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287596|NCT02904226|BG007|Baseline|Part H (JTX-2011 + Pembrolizumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287597|NCT02904226|BG008|Baseline|Total|Total of all reporting groups
11287598|NCT02904226|FG000|Participant Flow|Part A (JTX-2011)|"Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion~JTX-2011: Specified dose on specified days"
11287599|NCT02904226|FG001|Participant Flow|Part B (JTX-2011 + Nivolumab)|"Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287600|NCT02904226|FG002|Participant Flow|Part C (JTX-2011)|"Phase 2 expansion of JTX-2011 by IV infusion~JTX-2011: Specified dose on specified days"
11287601|NCT02904226|FG003|Participant Flow|Part D (JTX-2011 + Nivolumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287602|NCT02904226|FG004|Participant Flow|Part E (JTX-2011 + Ipilimumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287603|NCT02904226|FG005|Participant Flow|Part F (JTX-2011 + Ipilimumab)|Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days
11287604|NCT02904226|FG006|Participant Flow|Part G (JTX-2011 + Pembrolizumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287605|NCT02904226|FG007|Participant Flow|Part H (JTX-2011 + Pembrolizumab)|Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
11287606|NCT02904226|OG000|Outcome|Part A (JTX-2011)|"Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion~JTX-2011: Specified dose on specified days"
11287607|NCT02904226|OG001|Outcome|Part B (JTX-2011 + Nivolumab)|"Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287608|NCT02904226|OG002|Outcome|Part C (JTX-2011)|"Phase 2 expansion of JTX-2011 by IV infusion~JTX-2011: Specified dose on specified days"
11287609|NCT02904226|OG003|Outcome|Part D (JTX-2011 + Nivolumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
10822130|NCT00074711|BG002|Baseline|Total|Total of all reporting groups
10822131|NCT00074711|FG000|Participant Flow|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
11287610|NCT02904226|OG004|Outcome|Part E (JTX-2011 + Ipilimumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287611|NCT02904226|OG005|Outcome|Part G (JTX-2011 + Pembrolizumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287612|NCT02904226|EG000|Reported Event|Part A (JTX-2011)|"Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion~JTX-2011: Specified dose on specified days"
11287613|NCT02904226|EG001|Reported Event|Part B (JTX-2011 + Nivolumab)|"Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287614|NCT02904226|EG002|Reported Event|Part C (JTX-2011)|"Phase 2 expansion of JTX-2011 by IV infusion~JTX-2011: Specified dose on specified days"
11287615|NCT02904226|EG003|Reported Event|Part D (JTX-2011 + Nivolumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion~JTX-2011: Specified dose on specified days~Nivolumab: Specified dose on specified days"
11287616|NCT02904226|EG004|Reported Event|Part E (JTX-2011 + Ipilimumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287617|NCT02904226|EG005|Reported Event|Part F (JTX-2011 + Ipilimumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion~JTX-2011: Specified dose on specified days~Ipilimumab: Specified dose on specified days"
11287618|NCT02904226|EG006|Reported Event|Part G (JTX-2011 + Pembrolizumab)|"Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287619|NCT02904226|EG007|Reported Event|Part H (JTX-2011 + Pembrolizumab)|"Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion~JTX-2011: Specified dose on specified days~Pembrolizumab: Specified dose on specified days"
11287620|NCT02904265|BG000|Baseline|Diazepam|Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.
11287621|NCT02904265|BG001|Baseline|Acetazolamide|"Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.~Acetazolamide"
10970626|NCT00911300|EG001|Reported Event|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
10970627|NCT00911326|BG000|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
10970628|NCT00911326|FG000|Participant Flow|Lymphoseek|Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
10970629|NCT00911326|OG000|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
10970630|NCT00911326|EG000|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
10970631|NCT00911495|BG000|Baseline|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
10970632|NCT00911495|FG000|Participant Flow|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
10970633|NCT00911495|OG000|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
10970634|NCT00911495|EG000|Reported Event|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
10970635|NCT00911508|BG000|Baseline|Left Atrial Ablation|All patients randomized to the ablation group were required to undergo left atrial pulmonary vein isolation. The addition of ancillary ablation techniques including linear, ganglion plexus, and electrogram-based approaches were left to the discretion of the investigators.
10970636|NCT00911508|BG001|Baseline|Rate or Rhythm Control Therapy|All patients randomized to drug therapy, were treated with standard rhythm and/or rate control drugs selected in accordance with contemporary guidelines, according to investigator discretion.
10970637|NCT00911508|BG002|Baseline|Total|Total of all reporting groups
10970638|NCT00911508|FG000|Participant Flow|Left Atrial Ablation|All patients randomized to the ablation group were required to undergo left atrial pulmonary vein isolation. The addition of ancillary ablation techniques including linear, ganglion plexus, and electrogram-based approaches were left to the discretion of the investigators.
10970639|NCT00911508|FG001|Participant Flow|Rate or Rhythm Control Therapy|All patients randomized to drug therapy, were treated with standard rhythm and/or rate control drugs selected in accordance with contemporary guidelines, according to investigator discretion.
10970640|NCT00911508|OG000|Outcome|Left Atrial Ablation|All patients randomized to the ablation group were required to undergo left atrial pulmonary vein isolation. The addition of ancillary ablation techniques including linear, ganglion plexus, and electrogram-based approaches were left to the discretion of the investigators.
10970641|NCT00911508|OG001|Outcome|Rate or Rhythm Control Therapy|All patients randomized to drug therapy, were treated with standard rhythm and/or rate control drugs selected in accordance with contemporary guidelines, according to investigator discretion.
10970642|NCT00911508|EG000|Reported Event|Left Atrial Ablation|All patients randomized to the ablation group were required to undergo left atrial pulmonary vein isolation. The addition of ancillary ablation techniques including linear, ganglion plexus, and electrogram-based approaches were left to the discretion of the investigators.
10970643|NCT00911508|EG001|Reported Event|Rate or Rhythm Control Therapy|All patients randomized to drug therapy, were treated with standard rhythm and/or rate control drugs selected in accordance with contemporary guidelines, according to investigator discretion.
10970644|NCT00911534|BG000|Baseline|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
10970645|NCT00911534|BG001|Baseline|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
10970646|NCT00911534|BG002|Baseline|Total|Total of all reporting groups
10970647|NCT00911534|FG000|Participant Flow|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
10970648|NCT00911534|FG001|Participant Flow|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
10970649|NCT00911534|OG000|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
10970650|NCT00911534|OG001|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
10970651|NCT00911534|EG000|Reported Event|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
10970652|NCT00911534|EG001|Reported Event|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
10970653|NCT00911586|BG000|Baseline|Testosterone Undecanoate|"Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.~Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days"
11287622|NCT02904265|BG002|Baseline|Total|Total of all reporting groups
10970654|NCT00911586|FG000|Participant Flow|Testosterone Undecanoate|"Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.~Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days"
11215715|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
11215716|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
10970655|NCT00911586|OG000|Outcome|Testosterone Undecanoate|"Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.~Testosterone undecanoate"
11215717|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
11215718|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period.
11215719|NCT02301143|OG000|Outcome|Nab-Paclitaxel Plus Gemcitabine (Induction Period)|"nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.~Six treatment cycles were planned."
11215720|NCT02301143|OG001|Outcome|Nab-Paclitaxel Plus Gemcitabine (Overall)|"nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.~Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period."
11215721|NCT02301143|EG000|Reported Event|Nab-Paclitaxel Plus Gemcitabine (Induction Period)|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
10970656|NCT00911586|OG000|Outcome|Testosterone Undecanoate|Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
11215722|NCT02301143|EG001|Reported Event|Nab-Paclitaxel Plus Gemcitabine (Overall)|nab-Paclitaxel 125 mg/m^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
11215723|NCT02301169|BG000|Baseline|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215724|NCT02301169|BG001|Baseline|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215725|NCT02301169|BG002|Baseline|Total|Total of all reporting groups
11215726|NCT02301169|FG000|Participant Flow|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215727|NCT02301169|FG001|Participant Flow|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215728|NCT02301169|OG000|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215729|NCT02301169|OG001|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
10970657|NCT00911586|EG000|Reported Event|Testosterone Undecanoate|"Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.~Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days"
11215730|NCT02301169|EG000|Reported Event|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215731|NCT02301169|EG001|Reported Event|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
11215732|NCT02301299|BG000|Baseline|Intervention Hospital|Neighborhoods in the south side of Chicago surrounding the primary intervention stroke center hospital was targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators monitored early hospital arrival and EMS use for stroke over a 60-month period at the primary intervention stroke center hospitals using an interrupted time-series analysis.
11215733|NCT02301299|FG000|Participant Flow|Intervention Hospital|Neighborhoods in the south side of Chicago surrounding the primary intervention stroke center hospital was targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators monitored early hospital arrival and EMS use for stroke over a 60-month period at the primary intervention stroke center hospital using an interrupted time-series analysis.
11215734|NCT02301299|OG000|Outcome|Intervention Hospital|Analysis goal: to examine the impact of the CEERIAS intervention (December 2015-March 2016) on early arrival (≤3 hours) among ischemic stroke patients.
11215735|NCT02301299|OG000|Outcome|Intervention Hospital|CEERIAS Hospital Data Interrupted Time Series Analysis EMS arrival: based on Chicago Fire Department records for Trinity Hospital
11215736|NCT02301299|OG000|Outcome|Pre-intervention|Pre-intervention survey group
11215737|NCT02301299|OG001|Outcome|Post-intervention|Post-intervention survey group
11215738|NCT02301299|EG000|Reported Event|Community-based Stroke Awareness Program|"Neighborhoods in the south side of Chicago surrounding 2 primary stroke center hospitals will be targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators will monitor early hospital arrival and EMS use for stroke over a 60-month period at the 2 primary stroke center hospitals using an interrupted time-series analysis.~Community-based Stroke Awareness Program: A culturally-adapted stroke awareness and action program will be delivered by trained Stroke Promoters in the targeted neighborhoods in the south side of Chicago. They will be trained on 1) benefits of early recognition and EMS utilization for stroke (ie stroke centers, tPA) 2) culturally-adapted solutions to current barriers (ie misperceptions about vulnerability, severity, mistrust, costs) and 3) cues to aid in stroke recognition and immediate action. The intervention will take place at community settings throughout a 1-year period."
11215739|NCT02301364|BG000|Baseline|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
11215740|NCT02301364|FG000|Participant Flow|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
11215741|NCT02301364|OG000|Outcome|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
10970658|NCT00911612|BG000|Baseline|Colesevelam|Participants received colesevelam 1.875 g twice daily
11215742|NCT02301364|EG000|Reported Event|Buparlisib (BKM120)|This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
11215743|NCT02301377|BG000|Baseline|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
11215744|NCT02301377|BG001|Baseline|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
11215745|NCT02301377|BG002|Baseline|Total|Total of all reporting groups
11215746|NCT02301377|FG000|Participant Flow|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
11215747|NCT02301377|FG001|Participant Flow|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
11287623|NCT02904265|FG000|Participant Flow|Diazepam|"Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.~Diazepam"
11287624|NCT02904265|FG001|Participant Flow|Acetazolamide|"Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.~Acetazolamide"
11287625|NCT02904265|OG000|Outcome|Diazepam|"Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.~Diazepam"
11287626|NCT02904265|OG001|Outcome|Acetazolamide|"Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.~Acetazolamide"
11287627|NCT02904265|EG000|Reported Event|Diazepam|"Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.~Diazepam"
11287628|NCT02904265|EG001|Reported Event|Acetazolamide|"Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.~Acetazolamide"
11287629|NCT02904512|BG000|Baseline|Continuous Glucose Monitoring and Point of Care Blood Glucose|"Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose~Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose"
11287630|NCT02904512|BG001|Baseline|Point of Care (POC) Blood Glucose|"Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only~Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose"
11287631|NCT02904512|BG002|Baseline|Total|Total of all reporting groups
11287632|NCT02904512|FG000|Participant Flow|Continuous Glucose Monitoring and Point of Care Blood Glucose|"Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose~Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose"
11287633|NCT02904512|FG001|Participant Flow|Point of Care (POC) Blood Glucose|"Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only~Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose"
11287634|NCT02904512|OG000|Outcome|Continuous Glucose Monitoring and Point of Care Blood Glucose|"Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose~Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose"
11287635|NCT02904512|OG001|Outcome|Point of Care (POC) Blood Glucose|"Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only~Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose"
11287636|NCT02904512|EG000|Reported Event|Continuous Glucose Monitoring and Point of Care Blood Glucose|"Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose~Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose"
11287637|NCT02904512|EG001|Reported Event|Point of Care (POC) Blood Glucose|"Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only~Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose"
11287638|NCT02904902|BG000|Baseline|Adalimumab|Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4.
11287639|NCT02904902|FG000|Participant Flow|Adalimumab|Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4.
11287640|NCT02904902|OG000|Outcome|Adalimumab|Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4.
11287641|NCT02904902|EG000|Reported Event|Adalimumab|Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4.
11287642|NCT02904915|BG000|Baseline|Paracervical Block|"Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287643|NCT02904915|BG001|Baseline|No Analgesia|"IUD placement with no analgesia.~No analgesia: IUD placement without analgesia.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287644|NCT02904915|BG002|Baseline|Total|Total of all reporting groups
11287645|NCT02904915|FG000|Participant Flow|Paracervical Block|"Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287646|NCT02904915|FG001|Participant Flow|No Analgesia|"IUD placement with no analgesia.~No analgesia: IUD placement without analgesia.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287647|NCT02904915|OG000|Outcome|Paracervical Block|"Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287648|NCT02904915|OG001|Outcome|No Analgesia|"IUD placement with no analgesia.~No analgesia: IUD placement without analgesia.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
10822132|NCT00074711|FG001|Participant Flow|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
11287649|NCT02904915|EG000|Reported Event|Paracervical Block|"Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287650|NCT02904915|EG001|Reported Event|No Analgesia|"IUD placement with no analgesia.~No analgesia: IUD placement without analgesia.~Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine."
11287651|NCT02904954|BG000|Baseline|Arm 1 (Durvalumab Monotherapy)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously"
11287652|NCT02904954|BG001|Baseline|Arm 2 (Durvalumab Plus SBRT)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously~Durvalumab plus SBRT: Intravenously"
11287653|NCT02904954|BG002|Baseline|Total|Total of all reporting groups
11287654|NCT02904954|FG000|Participant Flow|Arm 1 (Durvalumab Monotherapy)|"Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.~Durvalumab: Intravenously"
11287655|NCT02904954|FG001|Participant Flow|Arm 2 (Durvalumab Plus SBRT)|"Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.~Durvalumab: Intravenously~Durvalumab plus SBRT: Intravenously"
11287656|NCT02904954|OG000|Outcome|Arm 1 (Durvalumab Monotherapy)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously"
11287657|NCT02904954|OG001|Outcome|Arm 2 (Durvalumab Plus SBRT)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously~Durvalumab plus SBRT: Intravenously"
11287658|NCT02904954|OG000|Outcome|Arm 1 (Durvalumab Monotherapy)|"Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.~Durvalumab: Intravenously"
11287659|NCT02904954|OG001|Outcome|Arm 2 (Durvalumab Plus SBRT)|"Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.~Durvalumab: Intravenously~Durvalumab plus SBRT: Intravenously"
11287660|NCT02904954|EG000|Reported Event|Arm 1 (Durvalumab Monotherapy)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously"
11287661|NCT02904954|EG001|Reported Event|Arm 2 (Durvalumab Plus SBRT)|"Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.~Durvalumab: Intravenously~Durvalumab plus SBRT: Intravenously"
11287662|NCT02905006|BG000|Baseline|Placebo|Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).
10822133|NCT00074711|OG000|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
10970659|NCT00911612|BG001|Baseline|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
10970660|NCT00911612|BG002|Baseline|Total|Total of all reporting groups
11287663|NCT02905006|BG001|Baseline|Bimekizumab 64 mg Q4W|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.
11287664|NCT02905006|BG002|Baseline|Bimekizumab 160 mg Q4W|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.
11287665|NCT02905006|BG003|Baseline|Bimekizumab 160 mg w/ LD Q4W|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.
11287666|NCT02905006|BG004|Baseline|Bimekizumab 320 mg Q4W|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.
11287667|NCT02905006|BG005|Baseline|Bimekizumab 480 mg Q4W|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.
11287668|NCT02905006|BG006|Baseline|Total Title|
11287669|NCT02905006|FG000|Participant Flow|Placebo|Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).
11287670|NCT02905006|FG001|Participant Flow|Bimekizumab 64 mg Q4W|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.
11287671|NCT02905006|FG002|Participant Flow|Bimekizumab 160 mg Q4W|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.
11287672|NCT02905006|FG003|Participant Flow|Bimekizumab 160 mg w/ LD Q4W|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.
11287673|NCT02905006|FG004|Participant Flow|Bimekizumab 320 mg Q4W|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.
11287674|NCT02905006|FG005|Participant Flow|Bimekizumab 480 mg Q4W|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.
11287675|NCT02905006|OG000|Outcome|Placebo (FAS)|Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).
11287676|NCT02905006|OG001|Outcome|Bimekizumab 64 mg Q4W (FAS)|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.
11287677|NCT02905006|OG002|Outcome|Bimekizumab 160 mg Q4W (FAS)|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.
11287678|NCT02905006|OG003|Outcome|Bimekizumab 160 mg w/ LD Q4W (FAS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.
11287679|NCT02905006|OG004|Outcome|Bimekizumab 320 mg Q4W (FAS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.
11287680|NCT02905006|OG005|Outcome|Bimekizumab 480 mg Q4W (FAS)|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
11287681|NCT02905006|OG000|Outcome|Bimekizumab 64 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287682|NCT02905006|OG001|Outcome|Bimekizumab 160 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287683|NCT02905006|OG002|Outcome|Bimekizumab 160 mg w/ LD Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287684|NCT02905006|OG003|Outcome|Bimekizumab 320 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287685|NCT02905006|OG004|Outcome|Bimekizumab 480 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287686|NCT02905006|OG000|Outcome|All Participants (PK-PPS)|Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS.
11287687|NCT02905006|OG000|Outcome|Placebo (PK-PPS)|Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
11287688|NCT02905006|OG001|Outcome|Bimekizumab 64 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS.
10970661|NCT00911612|FG000|Participant Flow|Colesevelam|Participants received colesevelam 1.875 g twice daily
11287689|NCT02905006|OG002|Outcome|Bimekizumab 160 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287690|NCT02905006|OG003|Outcome|Bimekizumab 160 mg w/ LD Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287691|NCT02905006|OG004|Outcome|Bimekizumab 320 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287692|NCT02905006|OG005|Outcome|Bimekizumab 480 mg Q4W (PK-PPS)|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the PK-PPS.
11287693|NCT02905006|OG000|Outcome|Placebo (SS)|Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
11287694|NCT02905006|OG001|Outcome|Bimekizumab 64 mg Q4W (SS)|Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
11287695|NCT02905006|OG002|Outcome|Bimekizumab 160 mg Q4W (SS)|Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
11287696|NCT02905006|OG003|Outcome|Bimekizumab 160 mg w/ LD Q4W (SS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
11287697|NCT02905006|OG004|Outcome|Bimekizumab 320 mg Q4W (SS)|Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
11287698|NCT02905006|OG005|Outcome|Bimekizumab 480 mg Q4W (SS)|Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
11287699|NCT02905006|EG000|Reported Event|Placebo (SS) Treatment Period|During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).
11287700|NCT02905006|EG001|Reported Event|Bimekizumab 64 mg Q4W (SS) Treatment Period|During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.
11287701|NCT02905006|EG002|Reported Event|Bimekizumab 160 mg Q4W (SS) Treatment Period|During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.
11287702|NCT02905006|EG003|Reported Event|Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period|During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.
11287703|NCT02905006|EG004|Reported Event|Bimekizumab 320 mg Q4W (SS) Treatment Period|During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.
11287704|NCT02905006|EG005|Reported Event|Bimekizumab 480 mg Q4W (SS) Treatment Period|During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.
11336284|NCT03565068|OG000|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11287705|NCT02905006|EG006|Reported Event|Placebo (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287706|NCT02905006|EG007|Reported Event|Bimekizumab 64 mg Q4W (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287707|NCT02905006|EG008|Reported Event|Bimekizumab 160 mg Q4W (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287708|NCT02905006|EG009|Reported Event|Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287709|NCT02905006|EG010|Reported Event|Bimekizumab 320 mg Q4W (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287710|NCT02905006|EG011|Reported Event|Bimekizumab 480 mg Q4W (SS) Post-Treatment Period|"At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication.~Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS."
11287711|NCT02905149|BG000|Baseline|Serrato|"Standard anesthesia+serratus plane block.~Serrato: Serratus plane block."
11287712|NCT02905149|BG001|Baseline|Control|"Standard anesthesia~Control: Standard anesthesia"
11287713|NCT02905149|BG002|Baseline|Total|Total of all reporting groups
11287714|NCT02905149|FG000|Participant Flow|Serrato|"Standard anesthesia+serratus plane block.~Serrato: Serratus plane block."
11287715|NCT02905149|FG001|Participant Flow|Control|"Standard anesthesia~Control: Standard anesthesia"
11287716|NCT02905149|OG000|Outcome|Serrato|"Standard anesthesia+serratus plane block.~Serrato: Serratus plane block."
11287717|NCT02905149|OG001|Outcome|Control|"Standard anesthesia~Control: Standard anesthesia"
11287718|NCT02905149|EG000|Reported Event|Serrato|"Standard anesthesia+serratus plane block.~Serrato: Serratus plane block."
11287719|NCT02905149|EG001|Reported Event|Control|"Standard anesthesia~Control: Standard anesthesia"
11287720|NCT02905266|BG000|Baseline|Fixed Ratio Combination|Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287721|NCT02905266|BG001|Baseline|Sequential Combination|Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287722|NCT02905266|BG002|Baseline|Total|Total of all reporting groups
11287723|NCT02905266|FG000|Participant Flow|Fixed Ratio Combination|Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287724|NCT02905266|FG001|Participant Flow|Sequential Combination|Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287725|NCT02905266|OG000|Outcome|Fixed Ratio Combination|Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287726|NCT02905266|OG001|Outcome|Sequential Combination|Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287727|NCT02905266|EG000|Reported Event|Fixed Ratio Combination|Concomitant administration of Nivolumab and Ipilimumab (1:3 protein-mass ratio) every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287728|NCT02905266|EG001|Reported Event|Sequential Combination|Sequential administration of Nivolumab and Ipilimumab every 3 weeks for 4 doses followed by Nivolumab flat dose in the Maintenance Phase
11287729|NCT02905331|BG000|Baseline|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
11287730|NCT02905331|BG001|Baseline|Guselkumab|Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
11287731|NCT02905331|BG002|Baseline|Total|Total of all reporting groups
11287732|NCT02905331|FG000|Participant Flow|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
11287733|NCT02905331|FG001|Participant Flow|Guselkumab|Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
11287734|NCT02905331|FG002|Participant Flow|Placebo to Guselkumab|Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
11287735|NCT02905331|OG000|Outcome|Placebo|Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
11287736|NCT02905331|OG001|Outcome|Guselkumab|Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
11287737|NCT02905331|EG000|Reported Event|Placebo (Week 0-16)|Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
11287738|NCT02905331|EG001|Reported Event|Guselkumab (Week 0-16)|Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
11287739|NCT02905331|EG002|Reported Event|Placebo to Guselkumab (Week 16-40)|Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
11287740|NCT02905331|EG003|Reported Event|Guselkumab (Week 16-40)|Participants received placebo at Week 16, and 100 mg guselkumab at Week 20 and 28.
11287741|NCT02905435|BG000|Baseline|Biodegradable Temporizing Matrix|"Biodegradable Temporizing Matrix (BTM)~Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied."
11287742|NCT02905435|FG000|Participant Flow|Biodegradable Temporizing Matrix|"Biodegradable Temporizing Matrix (BTM)~Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied."
11287743|NCT02905435|OG000|Outcome|Biodegradable Temporizing Matrix (BTM)|The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
11287744|NCT02905435|OG000|Outcome|Biodegradable Temporizing Matrix|"Biodegradable Temporizing Matrix (BTM)~Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied."
11287745|NCT02905435|EG000|Reported Event|Biodegradable Temporizing Matrix|"Biodegradable Temporizing Matrix (BTM)~Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied."
11287746|NCT02905825|BG000|Baseline|Indication for Helicobacter Pylori Testing|"Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.~BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea~BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea"
11287747|NCT02905825|FG000|Participant Flow|Indication for Helicobacter Pylori Testing|"Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.~BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea~BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea"
10822134|NCT00074711|OG001|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
11287748|NCT02905825|OG000|Outcome|Indication for Helicobacter Pylori Testing|"Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.~BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea~BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea"
11287749|NCT02905825|EG000|Reported Event|Indication for Helicobacter Pylori Testing|"Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.~BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea~BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea"
11287750|NCT02905981|BG000|Baseline|All Patients in Study|All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
11287751|NCT02905981|FG000|Participant Flow|All Participants|In this phase 2, open-label, 3-period study all participants enrolled underwent an oral iron absorption testing with Triferic when it is administered with Shohl's solution during 3 visits during Period 1. In Period 2 (dose titration), the patients received Shohl's solution and Triferic orally up to 3 times per day for 4 months. In Period 3 patients received Shohl's solution and Triferic orally up to 3 times per day for an additional 6 months
11287752|NCT02905981|OG000|Outcome|All Patients in Study|All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
11287753|NCT02905981|EG000|Reported Event|All Participants|In this phase 2, open-label, 3-period study all participants enrolled underwent an oral iron absorption testing with Triferic when it is administered with Shohl's solution during 3 visits during Period 1. In Period 2 (dose titration), the patients received Shohl's solution and Triferic orally up to 3 times per day for 4 months. In Period 3 patients received Shohl's solution and Triferic orally up to 3 times per day for an additional 6 months
11287754|NCT02906358|BG000|Baseline|Community-based Pain Self-management|"Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)~Community-based pain self-management"
11287755|NCT02906358|BG001|Baseline|Clinic-based Pain Self-management|"Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)~Clinic-based pain self-management"
11287756|NCT02906358|BG002|Baseline|Total|Total of all reporting groups
11287757|NCT02906358|FG000|Participant Flow|Community-based Pain Self-management|"Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)~Community-based pain self-management"
11287758|NCT02906358|FG001|Participant Flow|Clinic-based Pain Self-management|"Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)~Clinic-based pain self-management"
11287759|NCT02906358|OG000|Outcome|Community-based Pain Self-management|"Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)~Community-based pain self-management"
11287760|NCT02906358|OG001|Outcome|Clinic-based Pain Self-management|"Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)~Clinic-based pain self-management"
11287761|NCT02906358|EG000|Reported Event|Community-based Pain Self-management|"Community-based pain self-management: two, one-hour monthly meetings for first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)~Community-based pain self-management"
11287762|NCT02906358|EG001|Reported Event|Clinic-based Pain Self-management|"Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)~Clinic-based pain self-management"
11287763|NCT02906566|BG000|Baseline|Older Group Ages 55-75|Participants received retinol lotion on one arm and placebo to match on the other arm.
11287764|NCT02906566|BG001|Baseline|Young Group Ages 18-25|Participants in the group will give a tissue sample from one arm only for comparison.
11287765|NCT02906566|BG002|Baseline|Total|Total of all reporting groups
11287766|NCT02906566|FG000|Participant Flow|Older Group Ages 55-75|Participants received retinol lotion on one arm and placebo to match on the other arm.
11287767|NCT02906566|FG001|Participant Flow|Young Group Ages 18-25|Participants in the group will give a tissue sample from one arm only for comparison.
11287768|NCT02906566|OG000|Outcome|Older Group Ages 55-75|Participants received retinol lotion on one arm and placebo to match on the other arm.
11287769|NCT02906566|OG000|Outcome|Retinol Treated Arm|Participants in the older group (ages 55-75), retinol arm.
11287770|NCT02906566|OG001|Outcome|Placebo Treated Arm|Participants in the older group (ages 55-75), placebo arm.
11287771|NCT02906566|OG000|Outcome|Young Group Ages 18-25|Participants in the group will give a tissue sample from one arm only for comparison.
10822135|NCT00074711|EG000|Reported Event|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
10970662|NCT00911612|FG001|Participant Flow|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
10970663|NCT00911612|OG000|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
10970664|NCT00911612|OG001|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
11287772|NCT02906566|EG000|Reported Event|Older Group Ages 55-75|Participants received retinol lotion on one arm and placebo to match on the other arm.
11287773|NCT02906566|EG001|Reported Event|Young Group Ages 18-25|Participants in the group will give a tissue sample from one arm only for comparison.
11287774|NCT02906579|BG000|Baseline|All Participants|Once-daily study drug for 18 days: placebo for 3 days and escalating doses of IW-1973 for 15 days (10 mg, 20 mg, 30 mg, 40 mg, 50 mg for 3 days each).
11287775|NCT02906579|FG000|Participant Flow|All Participants|Once-daily study drug for 18 days: placebo for 3 days and escalating doses of IW-1973 for 15 days (10 mg, 20 mg, 30 mg, 40 mg, 50 mg for 3 days each).
11287776|NCT02906579|OG000|Outcome|Control|Placebo taken once daily Day 1-Day 3
11287777|NCT02906579|OG001|Outcome|10 mg IW-1973|10 mg IW-1973 take once daily Day 4-Day 6
11287778|NCT02906579|OG002|Outcome|20 mg IW-1973|20 mg IW-1973 taken once daily Day 7-Day 9
11287779|NCT02906579|OG003|Outcome|30 mg IW-1973|30 mg IW-1973 taken once daily Day 10-Day 12
11287780|NCT02906579|OG004|Outcome|40 mg IW-1973|40 mg IW-1973 taken once daily Day 13-Day 15
11287781|NCT02906579|OG005|Outcome|50 mg IW-1973|50 mg IW-1973 taken once daily Day 16-Day 18
11287782|NCT02906579|OG000|Outcome|All Participants|Once-daily study drug for 18 days: placebo for 3 days and escalating doses of IW-1973 for 15 days (10 mg, 20 mg, 30 mg, 40 mg, 50 mg for 3 days each).
11287783|NCT02906579|OG000|Outcome|10 mg IW-1973|10 mg IW-1973 take once daily Day 4-Day 6
11287784|NCT02906579|OG001|Outcome|20 mg IW-1973|20 mg IW-1973 taken once daily Day 7-Day 9
11287785|NCT02906579|OG002|Outcome|30 mg IW-1973|30 mg IW-1973 taken once daily Day 10-Day 12
11287786|NCT02906579|OG003|Outcome|40 mg IW-1973|40 mg IW-1973 taken once daily Day 13-Day 15
10822136|NCT00074711|EG001|Reported Event|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
11287787|NCT02906579|OG004|Outcome|50 mg IW-1973|50 mg IW-1973 taken once daily Day 16-Day 18
11287788|NCT02906579|EG000|Reported Event|Control|Placebo taken once daily Day 1-Day 3
11287789|NCT02906579|EG001|Reported Event|10 mg IW-1973|10 mg IW-1973 take once daily Day 4-Day 6
11287790|NCT02906579|EG002|Reported Event|20 mg IW-1973|20 mg IW-1973 taken once daily Day 7-Day 9
11287791|NCT02906579|EG003|Reported Event|30 mg IW-1973|30 mg IW-1973 taken once daily Day 10-Day 12
11287792|NCT02906579|EG004|Reported Event|40 mg IW-1973|40 mg IW-1973 taken once daily Day 13-Day 15
11287793|NCT02906579|EG005|Reported Event|50 mg IW-1973|50 mg IW-1973 taken once daily Day 16-Day 18
11287794|NCT02906644|BG000|Baseline|Lorcaserin + Patch|"Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch"
11287795|NCT02906644|BG001|Baseline|Patch|"Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch~placebo lorcaserin"
11287796|NCT02906644|BG002|Baseline|Total|Total of all reporting groups
11287797|NCT02906644|FG000|Participant Flow|Lorcaserin + Patch|"Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch"
11287798|NCT02906644|FG001|Participant Flow|Patch|"Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch~placebo lorcaserin"
11287799|NCT02906644|OG000|Outcome|Lorcaserin + Patch|"Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch"
11287800|NCT02906644|OG001|Outcome|Patch|"Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch~placebo lorcaserin"
11287801|NCT02906644|OG000|Outcome|Lorcaserin + Nicotine Patch|All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches.
11287802|NCT02906644|EG000|Reported Event|Lorcaserin + Patch|"Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. Group 1 will receive this combined treatment throughout the study; Group 2 will receive the combined treatment after the first 2 weeks of receiving the nicotine patch only (with placebo lorcaserin).~lorcaserin~nicotine patch"
11287803|NCT02906644|EG001|Reported Event|Patch (1st 2 Weeks)|"Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.~lorcaserin~nicotine patch~placebo lorcaserin"
11287804|NCT02906670|BG000|Baseline|1 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287805|NCT02906670|BG001|Baseline|2 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287806|NCT02906670|BG002|Baseline|4 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287807|NCT02906670|BG003|Baseline|6 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287808|NCT02906670|BG004|Baseline|9 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287809|NCT02906670|BG005|Baseline|6 mg/kg Q2W|Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287810|NCT02906670|BG006|Baseline|9 mg/kg Q2W|Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287811|NCT02906670|BG007|Baseline|9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287812|NCT02906670|BG008|Baseline|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287813|NCT02906670|BG009|Baseline|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287814|NCT02906670|BG010|Baseline|Total|Total of all reporting groups
11287815|NCT02906670|FG000|Participant Flow|1 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
11287816|NCT02906670|FG001|Participant Flow|2 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
11287817|NCT02906670|FG002|Participant Flow|4 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
11287818|NCT02906670|FG003|Participant Flow|6 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287819|NCT02906670|FG004|Participant Flow|9 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287820|NCT02906670|FG005|Participant Flow|6 mg/kg Q2W|Phase 1a: Patients are administered 6 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
11287821|NCT02906670|FG006|Participant Flow|9 mg/kg Q2W|Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
11287822|NCT02906670|FG007|Participant Flow|9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287823|NCT02906670|FG008|Participant Flow|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered 12 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287824|NCT02906670|FG009|Participant Flow|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered 15 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287825|NCT02906670|OG000|Outcome|1 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287826|NCT02906670|OG001|Outcome|2 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287827|NCT02906670|OG002|Outcome|4 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287828|NCT02906670|OG003|Outcome|6 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287829|NCT02906670|OG004|Outcome|9 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
10842399|NCT00246337|FG007|Participant Flow|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11287830|NCT02906670|OG005|Outcome|6 mg/kg Q2W|Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287831|NCT02906670|OG006|Outcome|9 mg/kg Q2W|Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287832|NCT02906670|OG007|Outcome|9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11333859|NCT03520920|OG002|Outcome|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11287833|NCT02906670|OG008|Outcome|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287834|NCT02906670|OG009|Outcome|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287835|NCT02906670|OG000|Outcome|Phase 2a Dose-Expansion Cohort A|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287836|NCT02906670|OG001|Outcome|Phase 2a Dose-Expansion Cohort B|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287837|NCT02906670|OG002|Outcome|Phase 2a Dose-Expansion Cohort C|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287838|NCT02906670|OG003|Outcome|Phase 2a Dose-Expansion Cohort D|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287839|NCT02906670|OG000|Outcome|1 mg/kg Q1W|"Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287840|NCT02906670|OG001|Outcome|2 mg/kg Q1W|"Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287841|NCT02906670|OG002|Outcome|4 mg/kg Q1W|"Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
10970665|NCT00911612|EG000|Reported Event|Colesevelam|Participants received colesevelam 1.875 g twice daily
10970666|NCT00911612|EG001|Reported Event|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
10970667|NCT00911625|BG000|Baseline|0.5 Units/kg|"Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.5 units/kg daily insulin: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
10970668|NCT00911625|BG001|Baseline|0.25 Units/kg|"Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.25 units/kg daily insulin: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
10970669|NCT00911625|BG002|Baseline|Total|Total of all reporting groups
10970670|NCT00911625|FG000|Participant Flow|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10822137|NCT00074802|BG000|Baseline|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
10970671|NCT00911625|FG001|Participant Flow|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10970672|NCT00911625|OG000|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10970673|NCT00911625|OG001|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10970674|NCT00911625|EG000|Reported Event|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10970675|NCT00911625|EG001|Reported Event|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
10970676|NCT00911742|BG000|Baseline|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970677|NCT00911742|BG001|Baseline|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970678|NCT00911742|BG002|Baseline|Total|Total of all reporting groups
10970679|NCT00911742|FG000|Participant Flow|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970680|NCT00911742|FG001|Participant Flow|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970681|NCT00911742|OG000|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970682|NCT00911742|OG001|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10822138|NCT00074802|BG001|Baseline|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
10970683|NCT00911742|EG000|Reported Event|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970684|NCT00911742|EG001|Reported Event|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
10970685|NCT00911768|BG000|Baseline|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
10970686|NCT00911768|BG001|Baseline|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
10970687|NCT00911768|BG002|Baseline|Total|Total of all reporting groups
10970688|NCT00911768|FG000|Participant Flow|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
10970689|NCT00911768|FG001|Participant Flow|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
10970690|NCT00911768|OG000|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
10970691|NCT00911768|OG001|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
10970692|NCT00911768|EG000|Reported Event|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
10970693|NCT00911768|EG001|Reported Event|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
10970694|NCT00911807|BG000|Baseline|Cerebrolysin + Donepezil|
10970695|NCT00911807|BG001|Baseline|Cerebrolysin|
10970696|NCT00911807|BG002|Baseline|Donepezil|
10970697|NCT00911807|BG003|Baseline|Total|Total of all reporting groups
10970698|NCT00911807|FG000|Participant Flow|Cerebrolysin + Donepezil|
10970699|NCT00911807|FG001|Participant Flow|Cerebrolysin|
10970700|NCT00911807|FG002|Participant Flow|Donepezil|
10970701|NCT00911807|OG000|Outcome|Cerebrolysin + Donepezil|
10970702|NCT00911807|OG001|Outcome|Cerebrolysin|
10970703|NCT00911807|OG002|Outcome|Donepezil|
10970704|NCT00911807|EG000|Reported Event|Cerebrolysin + Donepezil|
10970705|NCT00911807|EG001|Reported Event|Cerebrolysin|
10970706|NCT00911807|EG002|Reported Event|Donepezil|
10970707|NCT00911820|BG000|Baseline|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
10970708|NCT00911820|BG001|Baseline|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
10970709|NCT00911820|BG002|Baseline|Total|Total of all reporting groups
10970710|NCT00911820|FG000|Participant Flow|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
10970711|NCT00911820|FG001|Participant Flow|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
10970712|NCT00911820|OG000|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
11336285|NCT03565068|OG001|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
10822139|NCT00074802|BG002|Baseline|Total|Total of all reporting groups
10970713|NCT00911820|OG001|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
10970714|NCT00911820|EG000|Reported Event|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
10970715|NCT00911820|EG001|Reported Event|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
10970716|NCT00911859|BG000|Baseline|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
10970717|NCT00911859|BG001|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
10970718|NCT00911859|BG002|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
10970719|NCT00911859|BG003|Baseline|Total|Total of all reporting groups
10970720|NCT00911859|FG000|Participant Flow|Part 1: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
10970721|NCT00911859|FG001|Participant Flow|Part 2: VMP|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287842|NCT02906670|OG003|Outcome|6 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287843|NCT02906670|OG004|Outcome|9 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287844|NCT02906670|OG005|Outcome|6 mg/kg Q2W|"Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287845|NCT02906670|OG006|Outcome|9 mg/kg Q2W|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287846|NCT02906670|OG007|Outcome|9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287847|NCT02906670|OG008|Outcome|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287848|NCT02906670|OG009|Outcome|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287849|NCT02906670|OG010|Outcome|Phase 2a Dose-Expansion Cohort A|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287850|NCT02906670|OG011|Outcome|Phase 2a Dose-Expansion Cohort B|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11333860|NCT03520920|OG000|Outcome|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
10842400|NCT00246337|FG008|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10970722|NCT00911859|FG002|Participant Flow|Part 2: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287851|NCT02906670|OG012|Outcome|Phase 2a Dose-Expansion Cohort C|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287852|NCT02906670|OG013|Outcome|Phase 2a Dose-Expansion Cohort D|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287853|NCT02906670|OG006|Outcome|9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287854|NCT02906670|OG007|Outcome|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287855|NCT02906670|OG008|Outcome|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287856|NCT02906670|OG009|Outcome|Phase 2a Dose-Expansion Cohort A|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287857|NCT02906670|OG010|Outcome|Phase 2a Dose-Expansion Cohort B|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287858|NCT02906670|OG011|Outcome|Phase 2a Dose-Expansion Cohort C|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11336286|NCT03565068|OG002|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336287|NCT03565068|OG003|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11336288|NCT03565068|OG004|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
10970723|NCT00911859|OG000|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287859|NCT02906670|OG012|Outcome|Phase 2a Dose-Expansion Cohort D|"Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets.~Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3."
11287860|NCT02906670|OG006|Outcome|9 mg/kg Q2W and 9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 (+ premedication) every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287861|NCT02906670|OG007|Outcome|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287862|NCT02906670|OG008|Outcome|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287863|NCT02906670|EG000|Reported Event|1 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287864|NCT02906670|EG001|Reported Event|2 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287865|NCT02906670|EG002|Reported Event|4 mg/kg Q1W|Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287866|NCT02906670|EG003|Reported Event|6 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287867|NCT02906670|EG004|Reported Event|9 mg/kg Q1W + Prophylaxis|"Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287868|NCT02906670|EG005|Reported Event|6 mg/kg Q2W|Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287869|NCT02906670|EG006|Reported Event|9 mg/kg Q2W|Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.
11287870|NCT02906670|EG007|Reported Event|9 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287871|NCT02906670|EG008|Reported Event|12 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287872|NCT02906670|EG009|Reported Event|15 mg/kg Q2W + Prophylaxis|"Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.~Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen."
11287873|NCT02906696|BG000|Baseline|Treatment (Bosutinib)|"Patients receive bosutinib PO daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bosutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11287874|NCT02906696|FG000|Participant Flow|Treatment (Bosutinib)|"Patients receive bosutinib PO daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bosutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11287875|NCT02906696|OG000|Outcome|Treatment (Bosutinib)|"Patients receive bosutinib PO daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bosutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11287876|NCT02906696|EG000|Reported Event|Treatment (Bosutinib)|"Patients receive bosutinib PO daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bosutinib: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11287877|NCT02906709|BG000|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
11287878|NCT02906709|BG001|Baseline|Placebo→Omarigliptin 25 mg|Placebo once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
11287879|NCT02906709|BG002|Baseline|Total|Total of all reporting groups
11287880|NCT02906709|FG000|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
11287881|NCT02906709|FG001|Participant Flow|Placebo→Omarigliptin 25 mg|Placebo once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
10970724|NCT00911859|OG001|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
10970725|NCT00911859|EG000|Reported Event|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287882|NCT02906709|OG000|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
11287883|NCT02906709|OG001|Outcome|Placebo|Placebo once weekly for 16 weeks (Phase A)
11287884|NCT02906709|OG000|Outcome|Omarigliptin 25 mg (Phase A and B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
11287885|NCT02906709|OG001|Outcome|Placebo→Omarigliptin 25 mg (Phase B Only)|Omarigliptin 25 mg once weekly for 36 weeks (Phase B, Week 17 to Week 52) after switching from placebo
11287886|NCT02906709|OG000|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
11287887|NCT02906709|OG001|Outcome|Placebo→Omarigliptin 25 mg|Placebo to Omarigliptin once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
11287888|NCT02906709|EG000|Reported Event|Omarigliptin 25 mg (Phase A)|Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
10970726|NCT00911859|EG001|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287889|NCT02906709|EG001|Reported Event|Placebo (Phase A)|Placebo once weekly for 16 weeks (Phase A)
11287890|NCT02906709|EG002|Reported Event|Omarigliptin 25 mg (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
11287891|NCT02906709|EG003|Reported Event|Placebo→Omarigliptin (Phase B Only)|Omarigliptin 25 mg once weekly for 36 weeks (Phase B) after switching from placebo
11287892|NCT02906813|BG000|Baseline|TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted|TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
11287893|NCT02906813|BG001|Baseline|TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed|TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3.
11287894|NCT02906813|BG002|Baseline|TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted|TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
11287895|NCT02906813|BG003|Baseline|Total|Total of all reporting groups
11287896|NCT02906813|FG000|Participant Flow|TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted|TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
11287897|NCT02906813|FG001|Participant Flow|TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed|TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3.
10822140|NCT00074802|FG000|Participant Flow|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
11287898|NCT02906813|FG002|Participant Flow|TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted|TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
11287899|NCT02906813|OG000|Outcome|TAK-935 300 mg Tablets Fed|TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
11287900|NCT02906813|OG001|Outcome|TAK-935 300 mg Tablets Fasted|TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
11287901|NCT02906813|OG002|Outcome|TAK-935 300 mg Solution Fasted|TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
11287902|NCT02906813|EG000|Reported Event|TAK-935 300 mg Tablets Fed|TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
11287903|NCT02906813|EG001|Reported Event|TAK-935 300 mg Tablets Fasted|TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
11287904|NCT02906813|EG002|Reported Event|TAK-935 300 mg Solution Fasted|TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
11287905|NCT02906917|BG000|Baseline|Insulin Degludec/Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s).
11287906|NCT02906917|BG001|Baseline|Insulin Glargine + Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
11287907|NCT02906917|BG002|Baseline|Total|Total of all reporting groups
11287908|NCT02906917|FG000|Participant Flow|Insulin Degludec/Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin degludec/insulin aspart (IDegAsp) once daily (OD) administered at the largest meal each day with or without oral antidiabetic drug(s) (OAD(s)). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/twice a day (BID) administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s).
11287909|NCT02906917|FG001|Participant Flow|Insulin Glargine + Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
11287910|NCT02906917|OG000|Outcome|Insulin Degludec/Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s).
11287911|NCT02906917|OG001|Outcome|Insulin Glargine + Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
11287912|NCT02906917|EG000|Reported Event|Insulin Degludec/Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s).
11332369|NCT03494725|EG000|Reported Event|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37~Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified by gender and stress level to both groups."
11287913|NCT02906917|EG001|Reported Event|Insulin Glargine + Insulin Aspart|Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
11287914|NCT02906930|BG000|Baseline|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 26.
11287915|NCT02906930|BG001|Baseline|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.
11287916|NCT02906930|BG002|Baseline|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11287917|NCT02906930|BG003|Baseline|Placebo|Participants were to take placebo tablets once daily for a period of 26 weeks.
11287918|NCT02906930|BG004|Baseline|Total|Total of all reporting groups
11287919|NCT02906930|FG000|Participant Flow|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 26.
11287920|NCT02906930|FG001|Participant Flow|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.
11287921|NCT02906930|FG002|Participant Flow|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11287922|NCT02906930|FG003|Participant Flow|Placebo|Participants were to take placebo tablets once daily for a period of 26 weeks.
11287923|NCT02906930|OG000|Outcome|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 26.
11287924|NCT02906930|OG001|Outcome|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.
11287925|NCT02906930|OG002|Outcome|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
11287926|NCT02906930|OG003|Outcome|Placebo|Participants were to take placebo tablets once daily for a period of 26 weeks.
10970727|NCT00911859|EG002|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
11287927|NCT02906930|EG000|Reported Event|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 26.
11287928|NCT02906930|EG001|Reported Event|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.
11287929|NCT02906930|EG002|Reported Event|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.
10970728|NCT00911859|EG003|Reported Event|Part 2, Maintenance Period: Siltuximab|Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
11287930|NCT02906930|EG003|Reported Event|Placebo|Participants were to take placebo tablets once daily for a period of 26 weeks.
11287931|NCT02907073|BG000|Baseline|Healthy Volunteers|"At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287932|NCT02907073|BG001|Baseline|Myeloma Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11332370|NCT03494725|EG001|Reported Event|Placebo|"Placebo: capsule manufactured to mimic Lpc-37 capsule~Ingredients: microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified by gender and stress level to both groups."
10822141|NCT00074802|FG001|Participant Flow|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
11287933|NCT02907073|BG002|Baseline|Endometrial Cancer Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287934|NCT02907073|BG003|Baseline|Total|Total of all reporting groups
11287935|NCT02907073|FG000|Participant Flow|Healthy Volunteers|"At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and Positron Emission Tomography (PET) imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.~BF4: Single IV dose of 9-11 millicurie (mCi) sodium [Fluorine-18] radiolabeled B4^F"
11287936|NCT02907073|FG001|Participant Flow|Myeloma Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287937|NCT02907073|FG002|Participant Flow|Endometrial Cancer Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287938|NCT02907073|OG000|Outcome|Healthy Volunteers|"At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287939|NCT02907073|OG001|Outcome|Myeloma Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287940|NCT02907073|OG002|Outcome|Endometrial Cancer Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287941|NCT02907073|EG000|Reported Event|Healthy Volunteers|"At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11332371|NCT03494816|BG000|Baseline|ITT Population|The Intention-to-treat (ITT) population includes all patients registered onto the study.
11287942|NCT02907073|EG001|Reported Event|Myeloma Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287943|NCT02907073|EG002|Reported Event|Endometrial Cancer Patients|"For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.~BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F"
11287944|NCT02907177|BG000|Baseline|Ponesimod Plus Dimethyl Fumarate (DMF)|Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287945|NCT02907177|BG001|Baseline|Placebo Plus Dimethyl Fumarate (DMF)|Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287946|NCT02907177|BG002|Baseline|Total|Total of all reporting groups
11287947|NCT02907177|FG000|Participant Flow|Ponesimod Plus Dimethyl Fumarate (DMF)|Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287948|NCT02907177|FG001|Participant Flow|Placebo Plus Dimethyl Fumarate (DMF)|Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287949|NCT02907177|OG000|Outcome|Ponesimod Plus Dimethyl Fumarate (DMF)|Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287950|NCT02907177|OG001|Outcome|Placebo Plus Dimethyl Fumarate (DMF)|Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287951|NCT02907177|EG000|Reported Event|Ponesimod Plus Dimethyl Fumarate (DMF)|Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11287952|NCT02907177|EG001|Reported Event|Placebo Plus Dimethyl Fumarate (DMF)|Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
11332372|NCT03494816|FG000|Participant Flow|Single Arm|"Axitinib - oral tablet twice daily for 8 weeks prior to surgery. Starting dose 5mg.~Axitinib Oral Tablet: Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities and blood pressure.~Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day with or without food as per instruction. On clinic days only, patients will be advised to fast for 6 hours prior to their clinic visit.~Patients should be advised to stop axitinib treatment a minimum of 36 hours and maximum of 7 days prior to week 9 nephrectomy and thrombectomy surgery.~Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol."
11332373|NCT03494816|OG000|Outcome|Evaluable Patients|The evaluable population includes all patients in the ITT population who have received at least one dose of the study drug (including any patients who were enrolled in error, received study drug and were subsequently found to be ineligible).
11332374|NCT03494816|OG000|Outcome|Surgical Population|The group of evaluable patients who had surgery.
11332375|NCT03494816|OG000|Outcome|Patients With Complete VTT Length Data at 9 Weeks|3 patients (no 9wk scan) + 1 (ineligible) pts were not included in the assessment of this timepoint.
11332376|NCT03494816|OG000|Outcome|Patients With Complete RECIST Data|3 evaluable pts did not have the relevant data and were removed from the analysis
11332377|NCT03494816|OG000|Outcome|Patients With Post-surgical Complications Within 30 Days|While 17 patients had surgery on this trial, only 6 patients had post-surgical complications within 30 days.
11332378|NCT03494816|EG000|Reported Event|ITT Population|The Intention-to-treat (ITT) population includes all patients registered onto the study.
11332379|NCT03494985|BG000|Baseline|OralBalance Moisturizing Gel|All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
11332380|NCT03494985|BG001|Baseline|Oral Rinse|All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
10970729|NCT00911898|BG000|Baseline|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
10970730|NCT00911898|FG000|Participant Flow|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
11287953|NCT02907216|BG000|Baseline|Co-administration Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287954|NCT02907216|BG001|Baseline|Staggered Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4.5, 6 month schedule and the liquid HRV vaccine according to a 2, 3.5 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287955|NCT02907216|BG002|Baseline|Total|Total of all reporting groups
11287956|NCT02907216|FG000|Participant Flow|Co-administration Group|Subjects aged 6 to 12 weeks who received the Squarekids vaccine (diphtheria, tetanus, pertussis and inactivated poliovirus [DPT-IPV] vaccine) according to a 3, 4, 6 month schedule and the liquid Rotarix vaccine (oral live attenuated human rotavirus [HRV] vaccine) according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287957|NCT02907216|FG001|Participant Flow|Staggered Group|Subjects aged 6 to 12 weeks who received the Squarekids vaccine (diphtheria, tetanus, pertussis and inactivated poliovirus [DPT-IPV] vaccine) according to a 3, 4.5, 6 month schedule and the liquid Rotarix vaccine (oral live attenuated human rotavirus [HRV] vaccine) according to a 2, 3.5 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287958|NCT02907216|OG000|Outcome|Co-administration Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287959|NCT02907216|OG001|Outcome|Staggered Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4.5, 6 month schedule and the liquid HRV vaccine according to a 2, 3.5 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
10970731|NCT00911898|OG000|Outcome|MM-111|All participants
11287960|NCT02907216|EG000|Reported Event|Co-administration Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4, 6 month schedule and the liquid HRV vaccine according to a 2, 3 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287961|NCT02907216|EG001|Reported Event|Staggered Group|Subjects aged 6 to 12 weeks who received the DPT-IPV vaccine according to a 3, 4.5, 6 month schedule and the liquid HRV vaccine according to a 2, 3.5 month schedule. The HRV vaccine was administered orally while the DTP-IPV vaccine was administered subcutaneously in the upper arm or upper thigh.
11287962|NCT02907268|BG000|Baseline|Treatment Arm A|The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.
11287963|NCT02907268|BG001|Baseline|Treatment Arm B|The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.
11287964|NCT02907268|BG002|Baseline|Total|Total of all reporting groups
11287965|NCT02907268|FG000|Participant Flow|Treatment Arm A|"The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across"
11332381|NCT03494985|BG002|Baseline|Moisturizing Mouth Spray|All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
11332382|NCT03494985|BG003|Baseline|Water Only Use|All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
10970732|NCT00911898|EG000|Reported Event|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
11332383|NCT03494985|BG004|Baseline|Total|Total of all reporting groups
10970733|NCT00911937|BG000|Baseline|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
10970734|NCT00911937|BG001|Baseline|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
10970735|NCT00911937|BG002|Baseline|Total|Total of all reporting groups
11287966|NCT02907268|FG001|Participant Flow|Treatment Arm B|"The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across"
11287967|NCT02907268|OG000|Outcome|Arm 1|Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
11287968|NCT02907268|EG000|Reported Event|Treatment Arm A|"The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead."
11287969|NCT02907268|EG001|Reported Event|Treatment Arm B|"The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.~onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.~abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead."
11287970|NCT02907463|BG000|Baseline|Per Protocol Cohort|The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287971|NCT02907463|FG000|Participant Flow|EDWARDS INTUITY Elite Valve System|The system includes the EDWARDS INTUITY Elite Aortic Valve, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB.
11287972|NCT02907463|OG000|Outcome|Per Protocol Cohort|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287973|NCT02907463|OG000|Outcome|Enrolled Cohort|A subject was considered enrolled into the registry when he/she signed the informed consent, and met all the registry eligibility criteria.
11287974|NCT02907463|OG000|Outcome|Per Protocol Cohort - 19mm|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287975|NCT02907463|OG001|Outcome|Per Protocol Cohort - 21mm|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287976|NCT02907463|OG002|Outcome|Per Protocol Cohort - 23mm|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287977|NCT02907463|OG003|Outcome|Per Protocol Cohort - 25mm|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287978|NCT02907463|OG004|Outcome|Per Protocol Cohort - 27mm|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287979|NCT02907463|OG005|Outcome|Per Protocol Cohort - Total|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287980|NCT02907463|OG005|Outcome|Per Protocol Cohort - All Subjects|The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287981|NCT02907463|EG000|Reported Event|Per Protocol Cohort|The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
11287982|NCT02907489|BG000|Baseline|Control: Calcium Hydroxide|non setting calcium hydroxide
11287983|NCT02907489|BG001|Baseline|Test: Triple Antibiotic Paste and Anti-Inflammatory Drug|Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
11287984|NCT02907489|BG002|Baseline|Total|Total of all reporting groups
11287985|NCT02907489|FG000|Participant Flow|Control: Calcium Hydroxide|Non-setting Calcium Hydroxide
11287986|NCT02907489|FG001|Participant Flow|Test: Triple Antibiotic Paste and Anti-Inflammatory Drug|Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
11287987|NCT02907489|OG000|Outcome|Control: Calcium Hydroxide|non setting calcium hydroxide
11287988|NCT02907489|OG001|Outcome|Test: Triple Antibiotic Paste and Anti-Inflammatory Drug|Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
11287989|NCT02907489|EG000|Reported Event|Control: Calcium Hydroxide|non setting calcium hydroxide
11287990|NCT02907489|EG001|Reported Event|Test: Triple Antibiotic Paste and Anti-Inflammatory Drug|Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
11287991|NCT02907619|BG000|Baseline|Sequence 1|In study B5161002 (parent study) participants randomized to Sequence group 1 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by intravenous (IV) infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received domagrozumab every 4 weeks for a total of 48 weeks at 40 mg/kg, the maximum tolerated dose identified in Period 1. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287992|NCT02907619|BG001|Baseline|Sequence 2|In study B5161002 (parent study) participants randomized to Sequence group 2 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received placebo. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287993|NCT02907619|BG002|Baseline|Sequence 3|In study B5161002 (parent study) participants randomized to Sequence group 3 received placebo in Period 1 (48 weeks). In Period 2, participants received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg). At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287994|NCT02907619|BG003|Baseline|Total|Total of all reporting groups
11287995|NCT02907619|FG000|Participant Flow|Sequence 1|In study B5161002 (parent study) participants randomized to Sequence group 1 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by intravenous (IV) infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received domagrozumab every 4 weeks for a total of 48 weeks at 40 mg/kg, the maximum tolerated dose identified in Period 1. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287996|NCT02907619|FG001|Participant Flow|Sequence 2|In study B5161002 (parent study) participants randomized to Sequence group 2 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received placebo. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287997|NCT02907619|FG002|Participant Flow|Sequence 3|In study B5161002 (parent study) participants randomized to Sequence group 3 received placebo in Period 1 (48 weeks). In Period 2, participants received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg). At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287998|NCT02907619|OG000|Outcome|Sequence 1|In study B5161002 (parent study) participants randomized to Sequence group 1 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by intravenous (IV) infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received domagrozumab every 4 weeks for a total of 48 weeks at 40 mg/kg, the maximum tolerated dose identified in Period 1. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11287999|NCT02907619|OG001|Outcome|Sequence 2|In study B5161002 (parent study) participants randomized to Sequence group 2 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received placebo. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11288000|NCT02907619|OG002|Outcome|Sequence 3|In study B5161002 (parent study) participants randomized to Sequence group 3 received placebo in Period 1 (48 weeks). In Period 2, participants received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg). At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11288001|NCT02907619|OG003|Outcome|Total|Sum of all participants in the study B5161004
11332384|NCT03494985|FG000|Participant Flow|OralBalance Moisturizing Gel|All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
11332385|NCT03494985|FG001|Participant Flow|Oral Rinse|All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
11332386|NCT03494985|FG002|Participant Flow|Moisturizing Mouth Spray|All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
11288002|NCT02907619|EG000|Reported Event|Sequence 1|In study B5161002 (parent study) participants randomized to Sequence group 1 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by intravenous (IV) infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received domagrozumab every 4 weeks for a total of 48 weeks at 40 mg/kg, the maximum tolerated dose identified in Period 1. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11288003|NCT02907619|EG001|Reported Event|Sequence 2|In study B5161002 (parent study) participants randomized to Sequence group 2 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received placebo. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11288004|NCT02907619|EG002|Reported Event|Sequence 3|In study B5161002 (parent study) participants randomized to Sequence group 3 received placebo in Period 1 (48 weeks). In Period 2, participants received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg). At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study.
11288005|NCT02907619|EG003|Reported Event|Total|Sum of all participants in the study B5161004
11288006|NCT02907814|BG000|Baseline|Uveitis and Cataract Imaging Group|"Subjects will undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed."
11288007|NCT02907814|BG001|Baseline|Control|"Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.~Eye Exam: This is a brief, non-contact ocular exam."
11288008|NCT02907814|BG002|Baseline|Total|Total of all reporting groups
11288009|NCT02907814|FG000|Participant Flow|Uveitis and Cataract Imaging Group|"Subjects will undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed."
11288010|NCT02907814|FG001|Participant Flow|Control|"Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.~Eye Exam: This is a brief, non-contact ocular exam."
11288011|NCT02907814|OG000|Outcome|Uveitis and Cataract Imaging Group|"Subjects will undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed."
11288012|NCT02907814|OG001|Outcome|Control|"Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.~Eye Exam: This is a brief, non-contact ocular exam."
11288013|NCT02907814|EG000|Reported Event|Uveitis and Cataract Imaging Group|"Subjects will undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed."
11288014|NCT02907814|EG001|Reported Event|Control|"Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.~Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.~Eye Exam: This is a brief, non-contact ocular exam."
11288015|NCT02907892|BG000|Baseline|Control|Standard cesarean section surgical technique per surgeon preference
11288016|NCT02907892|BG001|Baseline|Glove Change|"Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure~Glove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section"
10970736|NCT00911937|FG000|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
11288017|NCT02907892|BG002|Baseline|Total|Total of all reporting groups
11288018|NCT02907892|FG000|Participant Flow|Control|Standard cesarean section surgical technique per surgeon preference
11288019|NCT02907892|FG001|Participant Flow|Glove Change|"Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure~Glove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section"
11288020|NCT02907892|OG000|Outcome|Control|Standard cesarean section surgical technique per surgeon preference
11288021|NCT02907892|OG001|Outcome|Glove Change|"Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure~Glove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section"
11288022|NCT02907892|EG000|Reported Event|Control|Standard cesarean section surgical technique per surgeon preference
11288023|NCT02907892|EG001|Reported Event|Glove Change|"Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure~Glove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section"
11288024|NCT02907918|BG000|Baseline|Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288025|NCT02907918|FG000|Participant Flow|Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288026|NCT02907918|OG000|Outcome|Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288027|NCT02907918|OG000|Outcome|Baseline: Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288028|NCT02907918|OG001|Outcome|Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288029|NCT02907918|OG002|Outcome|End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288030|NCT02907918|EG000|Reported Event|Palbociclib + Letrozole + Trastuzumab +/- Goserelin|"Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles~Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician"
11288031|NCT02908100|BG000|Baseline|Placebo|Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288032|NCT02908100|BG001|Baseline|GDC-0853 (150mg) QD|Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288033|NCT02908100|BG002|Baseline|GDC-0853 (200mg) BID|Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288034|NCT02908100|BG003|Baseline|Total|Total of all reporting groups
11288035|NCT02908100|FG000|Participant Flow|Placebo|Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288036|NCT02908100|FG001|Participant Flow|GDC-0853 (150mg) QD|Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288037|NCT02908100|FG002|Participant Flow|GDC-0853 (200mg) BID|Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288038|NCT02908100|OG000|Outcome|Placebo|Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288039|NCT02908100|OG001|Outcome|GDC-0853 (150mg) QD|Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288040|NCT02908100|OG002|Outcome|GDC-0853 (200mg) BID|Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
10822142|NCT00074802|OG000|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
11288041|NCT02908100|OG000|Outcome|GDC-0853 (150mg) QD|Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288042|NCT02908100|OG001|Outcome|GDC-0853 (200mg) BID|Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288043|NCT02908100|EG000|Reported Event|Placebo|Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288044|NCT02908100|EG001|Reported Event|GDC-0853 (150mg) QD|Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288045|NCT02908100|EG002|Reported Event|GDC-0853 (200mg) BID|Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
11288046|NCT02908178|BG000|Baseline|Aim 1 Cohort: No SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group)."
11288047|NCT02908178|BG001|Baseline|Aim 1 Cohort: SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group)."
10970737|NCT00911937|FG001|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
11288048|NCT02908178|BG002|Baseline|Aim 2 Cohort: No SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group)."
11288049|NCT02908178|BG003|Baseline|Aim 2 Cohort: SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group)."
11288050|NCT02908178|BG004|Baseline|Total|Total of all reporting groups
11288051|NCT02908178|FG000|Participant Flow|Aim 1 Cohort - SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group received SLNB.~Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control)."
11288052|NCT02908178|FG001|Participant Flow|Aim 1 Cohort - No SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group did not receive SLNB.~Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control)."
11288053|NCT02908178|FG002|Participant Flow|Aim 2 Cohort - SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group received sentinel lymph node biopsy (SLNB).~Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control)."
11288054|NCT02908178|FG003|Participant Flow|Aim 2 Cohort - No SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group did not receive sentinel lymph node biopsy (SLNB).~Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control)."
11288055|NCT02908178|OG000|Outcome|Matched Aim 1 Cohort: No SLNB|"The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group)."
11332387|NCT03494985|FG003|Participant Flow|Water Only Use|All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
11332388|NCT03494985|OG000|Outcome|OralBalance Moisturizing Gel|All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
11332389|NCT03494985|OG001|Outcome|Oral Rinse|All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
11332390|NCT03494985|OG002|Outcome|Moisturizing Mouth Spray|All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
11332391|NCT03494985|OG003|Outcome|Water Only Use|All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
11332392|NCT03494985|EG000|Reported Event|OralBalance Moisturizing Gel|All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
11288056|NCT02908178|OG001|Outcome|Matched Aim 1 Cohort: SLNB|"The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group)."
11288057|NCT02908178|OG000|Outcome|Matched Aim 1 Cohort: No SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group)."
11288058|NCT02908178|OG001|Outcome|Matched Aim 1 Cohort: SLNB|"The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group)."
11288059|NCT02908178|OG000|Outcome|Matched Aim 2 Cohort: No SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group)."
11288060|NCT02908178|OG001|Outcome|Matched Aim 2 Cohort: SLNB|"The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.~Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group)."
11288061|NCT02908178|EG000|Reported Event||As a retrospective data analysis, we do not collect adverse event information.
11288062|NCT02908347|BG000|Baseline|MP1032|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient"
11288063|NCT02908347|BG001|Baseline|Placebo|"Placebo:~2 capsules of Placebo are provided orally twice daily for 42 days~Placebo: hard gelatine capsules without active ingredient"
11288064|NCT02908347|BG002|Baseline|Total|Total of all reporting groups
11288065|NCT02908347|FG000|Participant Flow|MP1032|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient"
11288066|NCT02908347|FG001|Participant Flow|Placebo|"Placebo:~2 capsules of Placebo are provided orally twice daily for 42 days~Placebo: hard gelatine capsules without active ingredient"
11288067|NCT02908347|OG000|Outcome|MP1032|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient"
11288068|NCT02908347|OG001|Outcome|Placebo|"Placebo:~2 capsules of Placebo are provided orally twice daily for 42 days~Placebo: hard gelatine capsules without active ingredient"
11288069|NCT02908347|OG000|Outcome|MP1032 PK Analysis Set|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Patients from the MP1032 group who provided plasma for PK purposes and completed the study."
11288070|NCT02908347|OG001|Outcome|AUC_2h Subgroup 1|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 1 according to AUC2h Day 1."
11288071|NCT02908347|OG002|Outcome|AUC_2h Subgroup 2|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 2 according to AUC2h Day 1."
11288072|NCT02908347|OG003|Outcome|AUC_2h Subgroup 3|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 3 according to AUC2h Day 1."
11288073|NCT02908347|OG004|Outcome|AUC_2h Subgroup 4|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 4 according to AUC2h Day 1."
11288074|NCT02908347|OG005|Outcome|Placebo PK Analysis Set|"Placebo:~2 capsules of Placebo are provided orally twice daily for 42 days~Placebo: hard gelatine capsules without active ingredient~Patients from the placebo group who provided plasma for PK purposes and completed the study."
11288075|NCT02908347|OG001|Outcome|AUC_t Subgroup 1|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 1 according to AUCt Day 1."
11288076|NCT02908347|OG002|Outcome|AUC_t Subgroup 2|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 2 according to AUCt Day 1."
11288077|NCT02908347|OG003|Outcome|AUC_t Subgroup 3|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 3 according to AUCt Day 1."
10970738|NCT00911937|OG000|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
10970739|NCT00911937|OG001|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
11288078|NCT02908347|OG004|Outcome|AUC_t Subgroup 4|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient~Subgroup 4 according to AUCt Day 1."
11288079|NCT02908347|OG000|Outcome|AUC Subgroup 1|6 patients with the lowest AUC 2h or AUC t, respectively
11288080|NCT02908347|OG001|Outcome|AUC Subgroup 2|5 patients with the next highest AUC 2h or AUC t, respectively
11288081|NCT02908347|OG002|Outcome|AUC Subgroup 3|6 patients with the next highest AUC 2h or AUC t, respectively
11288082|NCT02908347|OG003|Outcome|AUC Subgroup 4|5 patients with the highest AUC 2h or AUC t, respectively
11288083|NCT02908347|EG000|Reported Event|MP1032|"Test Product:~100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days~MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient"
11288084|NCT02908347|EG001|Reported Event|Placebo|"Placebo:~2 capsules of Placebo are provided orally twice daily for 42 days~Placebo: hard gelatine capsules without active ingredient"
11288085|NCT02908464|BG000|Baseline|Lumosity (CT Group)|"Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain brain games that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively.~Lumosity: A neurocognitive training program designed to enhance cognitive abilities"
11288086|NCT02908464|BG001|Baseline|Usual Care (Control Group)|Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account.
10970740|NCT00911937|EG000|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
11288087|NCT02908464|BG002|Baseline|Total|Total of all reporting groups
11332393|NCT03494985|EG001|Reported Event|Oral Rinse|All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
11332394|NCT03494985|EG002|Reported Event|Moisturizing Mouth Spray|All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
11332395|NCT03494985|EG003|Reported Event|Water Only Use|All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
11332396|NCT03495102|BG000|Baseline|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
11332397|NCT03495102|BG001|Baseline|Dulaglutide 3 mg|Dulaglutide 3 mg administered SC once a week.
11332398|NCT03495102|BG002|Baseline|Dulaglutide 4.5 mg|Dulaglutide 4.5 mg administered SC once a week.
11332399|NCT03495102|BG003|Baseline|Total|Total of all reporting groups
11332400|NCT03495102|FG000|Participant Flow|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
11332401|NCT03495102|FG001|Participant Flow|Dulaglutide 3 mg|Dulaglutide 3 mg administered SC once a week.
11332402|NCT03495102|FG002|Participant Flow|Dulaglutide 4.5 mg|Dulaglutide 4.5 mg administered SC once a week.
11332403|NCT03495102|OG000|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
11332404|NCT03495102|OG001|Outcome|Dulaglutide 3 mg|Dulaglutide 3 mg administered SC once a week.
11332405|NCT03495102|OG002|Outcome|Dulaglutide 4.5 mg|Dulaglutide 4.5 mg administered SC once a week.
11332406|NCT03495102|EG000|Reported Event|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
11332407|NCT03495102|EG001|Reported Event|Dulaglutide 3 mg|Dulaglutide 3 mg administered SC once a week.
11332408|NCT03495102|EG002|Reported Event|Dulaglutide 4.5 mg|Dulaglutide 4.5 mg administered SC once a week.
11332409|NCT03495648|BG000|Baseline|Walking Group (Low Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. Low engagers are defined as those participants who walked to the market two or fewer times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332410|NCT03495648|BG001|Baseline|Walking Group (High Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. High engagers are defined as those participants who walked to the market three or more times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332411|NCT03495648|BG002|Baseline|Total|Total of all reporting groups
11332412|NCT03495648|FG000|Participant Flow|Walking Group (Low Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. Low engagers are defined as those participants who walked to the market two or fewer times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332413|NCT03495648|FG001|Participant Flow|Walking Group (High Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. High engagers are defined as those participants who walked to the market three or more times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332414|NCT03495648|OG000|Outcome|Walking Group (Low Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. Low engagers are defined as those participants who walked to the market two or fewer times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332415|NCT03495648|OG001|Outcome|Walking Group (High Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. High engagers are defined as those participants who walked to the market three or more times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11332416|NCT03495648|EG000|Reported Event|Walking Group (Low Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. Low engagers are defined as those participants who walked to the market two or fewer times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
11333861|NCT03520920|OG001|Outcome|Relapsed/Refractory Follicular Lymphoma|Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
10970741|NCT00911937|EG001|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
10970742|NCT00911989|BG000|Baseline|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
11288088|NCT02908464|FG000|Participant Flow|Lumosity (CT Group)|"Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain brain games that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively.~Lumosity: A neurocognitive training program designed to enhance cognitive abilities"
11288089|NCT02908464|FG001|Participant Flow|Usual Care (Control Group)|Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account.
11288090|NCT02908464|OG000|Outcome|Overall Study Enrollment|This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
11288091|NCT02908464|OG000|Outcome|Lumosity (CT Group)|"Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain brain games that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively.~Lumosity: A neurocognitive training program designed to enhance cognitive abilities"
11288092|NCT02908464|OG001|Outcome|Usual Care (Control Group)|Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account.
11288093|NCT02908464|EG000|Reported Event|Lumosity (CT Group)|"Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain brain games that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively.~Lumosity: A neurocognitive training program designed to enhance cognitive abilities"
11288094|NCT02908464|EG001|Reported Event|Usual Care (Control Group)|Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account.
11288095|NCT02908490|BG000|Baseline|Initial Sildenafil|"Sildenafil 50 mg orally once daily for first 3 months, then after 2-week washout, Placebo orally once daily for 3 months~Sildenafil: Sildenafil 50 mg once daily~Placebo: Placebo once daily with same size, shape, color, and texture as Sildenafil 50 mg pill"
11288096|NCT02908490|BG001|Baseline|Initial Placebo|"Placebo orally once daily for first 3 months, then after 2-week washout, Sildenafil 50 mg orally once daily for 3 months~Sildenafil: Sildenafil 50 mg once daily~Placebo: Placebo once daily with same size, shape, color, and texture as Sildenafil 50 mg pill"
11288097|NCT02908490|BG002|Baseline|Total|Total of all reporting groups
11288098|NCT02908490|FG000|Participant Flow|Initial Sildenafil|"Sildenafil 50 mg orally once daily for first 3 months, then after 2-week washout, Placebo orally once daily for 3 months~Sildenafil: Sildenafil 50 mg once daily~Placebo: Placebo once daily with same size, shape, color, and texture as Sildenafil 50 mg pill"
11288099|NCT02908490|FG001|Participant Flow|Initial Placebo|"Placebo orally once daily for first 3 months, then after 2-week washout, Sildenafil 50 mg orally once daily for 3 months~Sildenafil: Sildenafil 50 mg once daily~Placebo: Placebo once daily with same size, shape, color, and texture as Sildenafil 50 mg pill"
11288100|NCT02908490|OG000|Outcome|Sildenafil Period|Participants who received Sildenafil 50 mg once daily in either the first or last 3 months of the study
11288101|NCT02908490|OG001|Outcome|Placebo Period|Participants who received Placebo tablets (matching Sildenafil 50 mg) once daily in either the first or last 3 months of the study
11288102|NCT02908490|EG000|Reported Event|Sildenafil Period|Participants who received Sildenafil 50 mg once daily in either the first or last 3 months of the study
11288103|NCT02908490|EG001|Reported Event|Placebo Period|Participants who received Placebo tablets (matching Sildenafil 50 mg) once daily in either the first or last 3 months of the study
11288104|NCT02908529|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11288105|NCT02908529|FG000|Participant Flow|Placebo First, Ato-Oxy Second|Placebo-matching ato-oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then ato-oxy administered 30 mins before normal sleep time on second study night.
10842401|NCT00246337|OG000|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
11288106|NCT02908529|FG001|Participant Flow|Ato-Oxy First, Placebo Second|Ato-Oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
11288107|NCT02908529|OG000|Outcome|Placebo|Placebo (2 tablets) 30 minutes hours before bedtime
11288108|NCT02908529|OG001|Outcome|Combination Product of Atomoxetine and Oxybutynin|Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 30 minutes before sleep
11288109|NCT02908529|OG000|Outcome|Placebo|"Placebo 2 hours before bedtime~Placebo, 2 tablets: Placebo 2 tablets 2 hours before sleep"
11288110|NCT02908529|OG001|Outcome|Combination Product of Atomoxetine and Oxybutynin|"Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep~Combination product of Atomoxetine and Oxybutynin: Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep"
11288111|NCT02908529|EG000|Reported Event|Placebo|Placebo 2 capsules 30 mins before bedtime
11288112|NCT02908529|EG001|Reported Event|Combination Product of Atomoxetine and Oxybutynin|Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 30 mins before sleep
11288113|NCT02908620|BG000|Baseline|One Spray CTY-5339-A, Then One Spray CTY-5339-CB|A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session.
10842402|NCT00246337|OG001|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842403|NCT00246337|OG002|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842404|NCT00246337|OG003|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11215748|NCT02301377|OG000|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
11215749|NCT02301377|OG001|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
11215750|NCT02301377|EG000|Reported Event|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
11215751|NCT02301377|EG001|Reported Event|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
11215752|NCT02301390|BG000|Baseline|Amiodarone Only|Amiodarone is a Class III antiarrhythmic agent.
11215753|NCT02301390|BG001|Baseline|Amiodarone + Catheter Ablation|"Amiodarone is a Class III antiarrhythmic agent.~Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia."
11215754|NCT02301390|BG002|Baseline|Total|Total of all reporting groups
11215755|NCT02301390|FG000|Participant Flow|Amiodarone Only|Amiodarone is a Class III antiarrhythmic agent.
11215756|NCT02301390|FG001|Participant Flow|Amiodarone + Catheter Ablation|"Amiodarone is a Class III antiarrhythmic agent.~Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia."
11215757|NCT02301390|OG000|Outcome|Amiodarone Only|Amiodarone is a Class III antiarrhythmic agent.
11215758|NCT02301390|OG001|Outcome|Amiodarone + Catheter Ablation|"Amiodarone is a Class III antiarrhythmic agent.~Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia."
11215759|NCT02301390|EG000|Reported Event|Amiodarone Only|Amiodarone is a Class III antiarrhythmic agent.
11215760|NCT02301390|EG001|Reported Event|Amiodarone + Catheter Ablation|"Amiodarone is a Class III antiarrhythmic agent.~Catheter VT Ablation: The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia."
11215761|NCT02301403|BG000|Baseline|Modern Usual Care|"Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).~Nicotine patch: 8 weeks of nicotine patch~in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website"
11215762|NCT02301403|BG001|Baseline|Abstinence-Optimized Cessation Treatment|"There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.~Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking~Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt~Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions~Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions~Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly"
11215763|NCT02301403|BG002|Baseline|Total|Total of all reporting groups
11215764|NCT02301403|FG000|Participant Flow|Modern Usual Care|"Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).~Nicotine patch: 8 weeks of nicotine patch~in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website"
11336289|NCT03565068|OG005|Outcome|Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11288114|NCT02908620|BG001|Baseline|2 Sprays CTY-5339-A, Then 1 Spray CTY-5339-CB +1 Spray Placebo|Two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session.
11288115|NCT02908620|BG002|Baseline|One Spray of CTY-5339-CB, Then One Spray CTY-5339-A|Two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session.
11288116|NCT02908620|BG003|Baseline|1 Spray CTY-5339-CB +1 Spray Placebo, Then 2 Sprays CTY-5339-A|A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session.
11288117|NCT02908620|BG004|Baseline|Total|Total of all reporting groups
11288118|NCT02908620|FG000|Participant Flow|One Spray CTY-5339-A, Then One Spray CTY-5339-CB|A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session.
11288119|NCT02908620|FG001|Participant Flow|2 Sprays CTY-5339-A, Then 1 Spray CTY-5339-CB +1 Spray Placebo|Two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session.
11288120|NCT02908620|FG002|Participant Flow|One Spray of CTY-5339-CB, Then One Spray CTY-5339-A|A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session.
11288121|NCT02908620|FG003|Participant Flow|1 Spray CTY-5339-CB +1 Spray Placebo, Then 2 Sprays CTY-5339-A|A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session.
11288122|NCT02908620|OG000|Outcome|One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.
11288123|NCT02908620|OG001|Outcome|One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.
11288124|NCT02908620|OG000|Outcome|Two Sprays CTY-5339-A|Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.
11288125|NCT02908620|OG001|Outcome|One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P|A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.
11288126|NCT02908620|OG001|Outcome|Two Sprays CTY-5339-A|Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.
11288127|NCT02908620|OG002|Outcome|One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.
11288128|NCT02908620|OG003|Outcome|One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P|A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.
11288129|NCT02908620|OG003|Outcome|CTY-5339-CB 1 Spray + Placebo 1 Spray|Benzocaine and Placebo; 14.0% Benzocaine, USP = 28 mg; 200 uL and one spray Vehicle control (no active ingredient); 200 uL
11288130|NCT02908620|EG000|Reported Event|CTY-5339-A 1 Spray|"Benzocaine and Tetracaine 14.0% Benzocaine, USP = 28 mg 2.0% Tetracaine Hydrochloride, USP = 4 mg~Benzocaine and Tetracaine: A single application 1 spray of a combination of benzocaine 14% and tetracaine 2% with a total dose of benzocaine 28 mg and tetracaine 2 mg per spray."
11288131|NCT02908620|EG001|Reported Event|CTY-5339-A 2 Sprays|"Benzocaine and Tetracaine 14.0% Benzocaine, USP = 56 mg 2.0% Tetracaine Hydrochloride, USP = 8 mg~Benzocaine and Tetracaine: A single application of 2 sprays of a combination of benzocaine 14% and tetracaine 2% with a total dose of benzocaine 28 mg and tetracaine 2 mg per spray."
11288132|NCT02908620|EG002|Reported Event|CTY-5339-CB 1 Spray|"Benzocaine only 14.0% Benzocaine, USP = 28 mg~Benzocaine only: Benzocaine 14% alone 200 uL (1 spray)~A single application of 1 spray of benzocaine 14% with a total dose of benzocaine 28 mg."
11288133|NCT02908620|EG003|Reported Event|CTY-5339-CB 1 Spray + Placebo 1 Spray|"Benzocaine and Placebo 14.0% Benzocaine, USP = 28 mg; 200 uL and one spray Vehicle control (no active ingredient); 200 uL~A single application of 1 spray of benzocaine 14% and a single spray of placebo with a total dose of benzocaine 28 mg."
11288134|NCT02908841|BG000|Baseline|Control|Standard of Care
11288135|NCT02908841|BG001|Baseline|Treatment|Surgicel Snow
11288136|NCT02908841|BG002|Baseline|Total|Total of all reporting groups
10842405|NCT00246337|OG004|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11332417|NCT03495648|EG001|Reported Event|Walking Group (High Engagers)|"Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. High engagers are defined as those participants who walked to the market three or more times during the program.~walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market."
10842406|NCT00246337|OG005|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842407|NCT00246337|OG006|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11332418|NCT03495817|BG000|Baseline|ATI-50002 Topical Solution|"This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.~Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.~Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks."
11332419|NCT03495817|FG000|Participant Flow|ATI-50002 Topical Solution|"This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.~Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.~Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks."
11332420|NCT03495817|OG000|Outcome|ATI-50002 Topical Solution|"This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.~Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.~Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks."
11332421|NCT03495817|EG000|Reported Event|ATI-50002 Topical Solution|"This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.~Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.~Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks."
11332422|NCT03495856|BG000|Baseline|Mindfulness Training|4-week mindfulness skills group for adults with chronic pain
11332423|NCT03495856|FG000|Participant Flow|Mindfulness Training|4-week mindfulness skills group for adults with chronic pain
11332424|NCT03495856|OG000|Outcome|Mindfulness Training|4-week mindfulness skills group for adults with chronic pain
11332425|NCT03495856|EG000|Reported Event|Mindfulness Training|4-week mindfulness skills group for adults with chronic pain
11332426|NCT03495869|BG000|Baseline|Individuals With Cocaine Use Disorder|"This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).~Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)"
11332427|NCT03495869|BG001|Baseline|Individuals With Opioid Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
11332428|NCT03495869|BG002|Baseline|Individuals With Marijuana Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
11332429|NCT03495869|BG003|Baseline|Healthy Controls|This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
11332430|NCT03495869|BG004|Baseline|Total|Total of all reporting groups
11332431|NCT03495869|FG000|Participant Flow|Individuals With Cocaine Use Disorder|"This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).~Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)"
11332432|NCT03495869|FG001|Participant Flow|Individuals With Opioid Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
11332433|NCT03495869|FG002|Participant Flow|Individuals With Marijuana Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
11332434|NCT03495869|FG003|Participant Flow|Healthy Controls|This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
11332435|NCT03495869|OG000|Outcome|Individuals With Cocaine Use Disorder|"This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).~Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)"
11332436|NCT03495869|OG001|Outcome|Individuals With Opioid Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
11332437|NCT03495869|OG002|Outcome|Individuals With Marijuana Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
11332438|NCT03495869|OG003|Outcome|Healthy Controls|This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
11332439|NCT03495869|EG000|Reported Event|Individuals With Cocaine Use Disorder|"This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50).~Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)"
11332440|NCT03495869|EG001|Reported Event|Individuals With Opioid Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
11332441|NCT03495869|EG002|Reported Event|Individuals With Marijuana Use Disorder|This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
11332442|NCT03495869|EG003|Reported Event|Healthy Controls|This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
11332443|NCT03495908|BG000|Baseline|VGo With Regular Human Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
11288137|NCT02908841|FG000|Participant Flow|Control|"10 patients randomized to the control group and received standard of care. Control patients were managed with direct compression with gauze pads or laparotomy pads for four minutes. If hemostasis was not achieved by compression after four minutes, the source and rate of bleeding were reevaluated and management was determined by the surgeon. If the surgeon used SurgicelSnow to achieve hemostasis at some point after 4 minutes, the patient was included in the control group, but the data was flagged for the analysis. If failure of hemostasis at 4 minutes with an estimated loss of ≥25 cc/min, patient was managed as per judgment of surgeon. Persistent bleeding at the 10 minute observation point was treated as per the surgeon's judgment.~Standard of Care"
11288138|NCT02908841|FG001|Participant Flow|Treatment|"12 patients randomized to the treatment group received Surgicel Snow. For patients with qualifying bleeding (rated on initial evaluation as at least mild) who have been randomized to receive Surgicel Snow, a single thin layer of dry Surgicel Snow was applied over the area of bleeding and positioned firmly in direct contact to the areas of bleeding with blunt surgical instruments. Surgicel Snow was left in the cavity to be absorbed. Dry gauze was not placed over the material. No adjuncts was added to the enhance hemostasis, but patients with small arteriolar bleeding, pressure was maintained on the bleeding site for 60 seconds. Hemostatic failure at 4 minutes was reassessed for rate of blood loss and if the rate of loss was estimated at less than 25 cc per minute, additional observations were made at 7 and 10 minutes.~Surgicel Snow"
11288139|NCT02908841|OG000|Outcome|Control|Standard of Care
11288140|NCT02908841|OG001|Outcome|Treatment|Surgicel Snow
11288141|NCT02908841|EG000|Reported Event|Control|Subjects randomized to the control group and received standard of care.
11288142|NCT02908841|EG001|Reported Event|Treatment|Subjects randomized to the treatment group received Surgicel Snow.
11288143|NCT02908880|BG000|Baseline|MANTA Vascular Closure Device|"Open label, single arm study using the MANTA device, developed by Essential Medical, Inc.. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.~MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths."
11288144|NCT02908880|FG000|Participant Flow|MANTA Vascular Closure Device|"Open label, single arm study using the MANTA device, developed by Essential Medical, Inc.. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.~MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths."
11288145|NCT02908880|OG000|Outcome|MANTA Vascular Closure Device|"Open label, single arm study using the MANTA device, developed by Essential Medical, Inc.. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.~MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths."
11288146|NCT02908880|EG000|Reported Event|MANTA Vascular Closure Device|"Open label, single arm study using the MANTA device, developed by Essential Medical, Inc.. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.~MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths."
11288147|NCT02909101|BG000|Baseline|Active Cognitive Training (ACT)|"Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.~Active Cognitive Training (ACT): Cognitive training games"
11288148|NCT02909101|BG001|Baseline|Control Training (CON)|"Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.~Control Training (CON): Cognitive training games"
11288149|NCT02909101|BG002|Baseline|Total|Total of all reporting groups
11288150|NCT02909101|FG000|Participant Flow|Active Cognitive Training (ACT)|"Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.~Active Cognitive Training (ACT): Cognitive training games"
11288151|NCT02909101|FG001|Participant Flow|Control Training (CON)|"Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.~Control Training (CON): Cognitive training games"
11288152|NCT02909101|OG000|Outcome|Active Cognitive Training (ACT)|"Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.~Active Cognitive Training (ACT): Cognitive training games"
11288153|NCT02909101|OG001|Outcome|Control Training (CON)|"Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.~Control Training (CON): Cognitive training games"
11288154|NCT02909101|EG000|Reported Event|Active Cognitive Training (ACT)|"Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.~Active Cognitive Training (ACT): Cognitive training games"
11288155|NCT02909101|EG001|Reported Event|Control Training (CON)|"Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.~Control Training (CON): Cognitive training games"
11332444|NCT03495908|BG001|Baseline|VGo With Rapid Acting Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
11332445|NCT03495908|BG002|Baseline|Total|Total of all reporting groups
10842408|NCT00246337|OG007|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11288156|NCT02909140|BG000|Baseline|Topical Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%"
11288157|NCT02909140|BG001|Baseline|Intracameral Mydriasis|"Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288158|NCT02909140|BG002|Baseline|Topical + Intracameral Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288159|NCT02909140|BG003|Baseline|Total|Total of all reporting groups
11288160|NCT02909140|FG000|Participant Flow|Topical Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%"
11288161|NCT02909140|FG001|Participant Flow|Intracameral Mydriasis|"Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288162|NCT02909140|FG002|Participant Flow|Topical + Intracameral Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288163|NCT02909140|OG000|Outcome|Topical Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%"
11288164|NCT02909140|OG001|Outcome|Intracameral Mydriasis|"Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
10970743|NCT00911989|FG000|Participant Flow|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
11288165|NCT02909140|OG002|Outcome|Topical + Intracameral Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288166|NCT02909140|EG000|Reported Event|Topical Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%"
11288167|NCT02909140|EG001|Reported Event|Intracameral Mydriasis|"Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
10822143|NCT00074802|OG001|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
10970744|NCT00911989|OG000|Outcome|Transvaginal Sleeve Gastrectomy|All subjects on whom the surgery was attempted.
10970745|NCT00911989|EG000|Reported Event|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
10970746|NCT00912002|BG000|Baseline|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
11288168|NCT02909140|EG002|Reported Event|Topical + Intracameral Mydriasis|"Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.~Topical phenylephrine 2.5%~Topical cyclopentolate 1%~Intracameral Lidocaine 1%~Intracameral 0.2- 0.3ml of epinephrine 1:10,000"
11288169|NCT02909153|BG000|Baseline|Cohort 1|Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288170|NCT02909153|BG001|Baseline|Cohort 2|Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288171|NCT02909153|BG002|Baseline|Cohort 3|Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288172|NCT02909153|BG003|Baseline|Cohort 4|Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288173|NCT02909153|BG004|Baseline|Cohort 5|Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288174|NCT02909153|BG005|Baseline|Total|Total of all reporting groups
11288175|NCT02909153|FG000|Participant Flow|Cohort 1|Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288176|NCT02909153|FG001|Participant Flow|Cohort 2|Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
10822144|NCT00074802|EG000|Reported Event|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
11288177|NCT02909153|FG002|Participant Flow|Cohort 3|Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288178|NCT02909153|FG003|Participant Flow|Cohort 4|Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288179|NCT02909153|FG004|Participant Flow|Cohort 5|Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
10842409|NCT00246337|OG008|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11288180|NCT02909153|OG000|Outcome|Cohort 1|Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288181|NCT02909153|OG001|Outcome|Cohort 2|Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288182|NCT02909153|OG002|Outcome|Cohort 3|Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288183|NCT02909153|OG003|Outcome|Cohort 4|Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288184|NCT02909153|OG004|Outcome|Cohort 5|Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288185|NCT02909153|EG000|Reported Event|Cohort 1|Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288186|NCT02909153|EG001|Reported Event|Cohort 2|Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288187|NCT02909153|EG002|Reported Event|Cohort 3|Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288188|NCT02909153|EG003|Reported Event|Cohort 4|Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288189|NCT02909153|EG004|Reported Event|Cohort 5|Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
11288190|NCT02909439|BG000|Baseline|Neostigmine|"Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.~Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade."
11288191|NCT02909439|BG001|Baseline|Sugammadex|"Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.~Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade."
11288192|NCT02909439|BG002|Baseline|Total|Total of all reporting groups
11288193|NCT02909439|FG000|Participant Flow|Neostigmine|"Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.~Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade."
11288194|NCT02909439|FG001|Participant Flow|Sugammadex|"Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.~Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade."
11288195|NCT02909439|OG000|Outcome|Neostigmine|"Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.~Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade."
11288196|NCT02909439|OG001|Outcome|Sugammadex|"Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.~Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade."
11288197|NCT02909439|EG000|Reported Event|Neostigmine|"Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.~Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade."
11288198|NCT02909439|EG001|Reported Event|Sugammadex|"Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.~Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade."
11288199|NCT02909504|BG000|Baseline|Lithium|Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L
11288200|NCT02909504|FG000|Participant Flow|Lithium|Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L
11288201|NCT02909504|OG000|Outcome|Lithium Non Responders|Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L.
11288202|NCT02909504|OG001|Outcome|Lithium Responders|Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L.
11288203|NCT02909504|EG000|Reported Event|Lithium|Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L
11288204|NCT02909764|BG000|Baseline|Control Group [Regular Sodium Group]|Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
11288205|NCT02909764|BG001|Baseline|Low Sodium Group|"Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.~Low Sodium Group: Breakfast Cereal"
11288206|NCT02909764|BG002|Baseline|Total|Total of all reporting groups
11288207|NCT02909764|FG000|Participant Flow|Control Group [Regular Sodium Group]|Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period.
11288208|NCT02909764|FG001|Participant Flow|Low Sodium Group|"Intervention: Children will receive low sodium cereal to consume 4 times per week over an 8-week (2-month) period.~Low Sodium Group: Breakfast Cereal"
11288209|NCT02909764|OG000|Outcome|Control Group [Regular Sodium Group]|Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
11288210|NCT02909764|OG001|Outcome|Low Sodium Group|"Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.~Low Sodium Group: Breakfast Cereal"
11288211|NCT02909764|OG000|Outcome|Control Group [Regular Sodium Group]|Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period.
11288212|NCT02909764|OG001|Outcome|Low Sodium Group|"Intervention: Children will receive low sodium cereal to consume 4 times per week over an 8-week (2-month) period.~Low Sodium Group: Breakfast Cereal"
11288213|NCT02909764|OG000|Outcome|Control Group|Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
11288214|NCT02909764|EG000|Reported Event|Control Group [Regular Sodium Group]|Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period.
11288215|NCT02909764|EG001|Reported Event|Low Sodium Group|"Intervention: Children will receive low sodium cereal to consume 4 times per week over an 8-week (2-month) period.~Low Sodium Group: Breakfast Cereal"
11288216|NCT02909907|BG000|Baseline|Flexors Alone|"75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above."
11288217|NCT02909907|BG001|Baseline|Flexors Plus Extensors|"150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.~Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above"
11288218|NCT02909907|BG002|Baseline|Total|Total of all reporting groups
11288219|NCT02909907|FG000|Participant Flow|Flexors Alone|"75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above."
11288220|NCT02909907|FG001|Participant Flow|Flexors Plus Extensors|"150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.~Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above"
11288221|NCT02909907|OG000|Outcome|Flexors Alone|"75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above."
11288222|NCT02909907|OG001|Outcome|Flexors Plus Extensors|"150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.~Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above"
11288223|NCT02909907|EG000|Reported Event|Flexors Alone|"75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above."
11288224|NCT02909907|EG001|Reported Event|Flexors Plus Extensors|"150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)~Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.~Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above"
11288225|NCT02909959|BG000|Baseline|Sulforaphane|"Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.~The weight-based dosing schedule is as follows:~3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb"
11288226|NCT02909959|BG001|Baseline|Placebo|Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
11288227|NCT02909959|BG002|Baseline|Total|Total of all reporting groups
11288228|NCT02909959|FG000|Participant Flow|Sulforaphane|"Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.~The weight-based dosing schedule is as follows:~3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb"
11288229|NCT02909959|FG001|Participant Flow|Placebo|Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
11288230|NCT02909959|OG000|Outcome|Sulforaphane|"Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.~The weight-based dosing schedule is as follows:~3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb"
11288231|NCT02909959|OG001|Outcome|Placebo|Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
11288232|NCT02909959|EG000|Reported Event|Sulforaphane|"Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane.~The weight-based dosing schedule is as follows:~3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb"
11288233|NCT02909959|EG001|Reported Event|Placebo|Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
10970747|NCT00912002|FG000|Participant Flow|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
11288234|NCT02910011|BG000|Baseline|Topical Administration of Study Drug|"2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days~Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner"
11288235|NCT02910011|FG000|Participant Flow|Topical Administration of Study Drug|"2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days~Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% daily for up to four weeks or until complete clearance whichever is sooner"
11288236|NCT02910011|OG000|Outcome|Topical Administration of Study Drug|"2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days~Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner"
11288237|NCT02910011|OG000|Outcome|All Subjects Received Active Drug|Topical Treatment with NanoDox for 14 to 28 days
11288238|NCT02910011|OG000|Outcome|All Subjects Received Active Drug|Treated with Nanodox topical for 14 to 28 days
11288239|NCT02910011|EG000|Reported Event|Topical Administration of Study Drug|"2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days~Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner"
11288240|NCT02910037|BG000|Baseline|Patients Enrolled for mNGS Testing|"Patients with meningitis and/or encephalitis will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective chart review and clinical reimbursement documents).~mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples."
11288241|NCT02910037|FG000|Participant Flow|Patients Enrolled for mNGS Testing|"Patients with meningitis and/or encephalitis will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective chart review and clinical reimbursement documents).~mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples."
11288242|NCT02910037|OG000|Outcome|Pre mNGS Result Feedback From Providers|Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
11288243|NCT02910037|OG001|Outcome|Post mNGS Results Feedback From Providers|Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
11288244|NCT02910037|OG000|Outcome|Patients Enrolled for mNGS Testing|"Patients with meningitis and/or encephalitis will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective chart review and clinical reimbursement documents).~mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples."
11288245|NCT02910037|OG000|Outcome|Autoimmune|Patients that received a definitive autoimmune diagnosis for their CNS disease.
11288246|NCT02910037|OG001|Outcome|Infectious|Patients that received a definite infectious disease diagnosis for their CNS disease.
11288247|NCT02910037|OG002|Outcome|Neoplastic|Patients that received a definitive neoplastic diagnosis for their CNS disease.
11288248|NCT02910037|OG003|Outcome|Post Infectious|Patients that received a definitive post infectious diagnosis for their CNS disease.
11288249|NCT02910037|OG004|Outcome|Toxic Metabolic|Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
11288250|NCT02910037|OG005|Outcome|Structural|Patients that received a definitive structural diagnosis for their CNS disease.
11288251|NCT02910037|OG006|Outcome|Vascular|Patients that received a definitive vascular diagnosis for their CNS disease.
11288252|NCT02910037|OG007|Outcome|Other|Patients that received a definitive diagnosis for their CNS disease in another category.
11288253|NCT02910037|OG008|Outcome|Unknown|Patients that did not received a definitive diagnosis for their CNS disease.
10970748|NCT00912002|OG000|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
11288254|NCT02910037|OG000|Outcome|mNGS Only Diagnosis, Confirmation Attempted|mNGS only diagnosis, confirmation attempted on remnant CSF and/or ancillary specimen(s) (i.e. brain biopsy)
11288255|NCT02910037|OG001|Outcome|Concordant With Conventional Testing|mNGS and conventional direct detection testing resulted in the same finding. Direct detection included culture and PCR. Results were considered concordant for this measure if conventional testing was positive by indirect testing (i.e. antibody) and both direct detection (i.e. PCR) and mNGS were negative.
11288256|NCT02910037|OG002|Outcome|Missed by mNGS|Missed by mNGS, includes those with reads under established reporting thresholds
11288257|NCT02910037|OG003|Outcome|False Positive by mNGS|False positives were reported when mNGS resulted an organism that was not detected by other method (direct and/or indirect) and was not thought to be clinically relevant by the treating clinicians. Incidental findings (i.e. HIV) were not reported as false positives.
11288258|NCT02910037|OG004|Outcome|mNGS Only Finding, Unable to Confirm|mNGS only finding, unable to confirm due to test or specimen unavailability
11288259|NCT02910037|EG000|Reported Event|Patients Enrolled for mNGS Testing|"Patients with meningitis and/or encephalitis will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective chart review and clinical reimbursement documents).~mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples."
11288260|NCT02910063|BG000|Baseline|Phase 2: Blinatumomab|"Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day."
11288261|NCT02910063|FG000|Participant Flow|Phase 2: Blinatumomab|"Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day."
11332446|NCT03495908|FG000|Participant Flow|VGo With Regular Human Insulin|Switch to U-100 Regular Human Insulin (RHI) delivered by the V-Go insulin delivery device.
10970749|NCT00912002|OG000|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
10970750|NCT00912002|EG000|Reported Event|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
11288262|NCT02910063|FG001|Participant Flow|Phase 3: Blinatumomab|"Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3."
11288263|NCT02910063|FG002|Participant Flow|Phase 3: Investigator's Choice (IC) Chemotherapy|"Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice.~In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3."
11288264|NCT02910063|OG000|Outcome|Phase 2: Blinatumomab|"Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day."
11288265|NCT02910063|OG000|Outcome|Phase 3: Blinatumomab|"Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3."
11288266|NCT02910063|OG001|Outcome|Phase 3: Investigator's Choice (IC) Chemotherapy|"Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice.~In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3."
11288267|NCT02910063|OG000|Outcome|Phase 2: Blinatumomab 9 µg/Day|All participants who received blinatumomab 9 µg/day continuous infusion which was administered for 7 days of in Week 1 of Cycle 1 (Cycle 1 was 70 days in length).
11288268|NCT02910063|OG001|Outcome|Phase 2: Blinatumomab 28 µg/Day|All participants who received blinatumomab 28 µg/day continuous infusion which was administered for 7 days in Week 2 of Cycle 1 (Cycle 1 was 70 days in length).
11288269|NCT02910063|OG002|Outcome|Phase 2: Blinatumomab 112 µg/Day|All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
11288270|NCT02910063|EG000|Reported Event|Phase 2: Blinatumomab|"Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days.~Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day."
11288271|NCT02910089|BG000|Baseline|Shared Decision Making/Brief Negotiated Interviewing|This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
11288272|NCT02910089|BG001|Baseline|Control Arm|Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
11288273|NCT02910089|BG002|Baseline|Total|Total of all reporting groups
11288274|NCT02910089|FG000|Participant Flow|Shared Decision Making/Brief Negotiated Interviewing|This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
11288275|NCT02910089|FG001|Participant Flow|Control Arm|Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
11288276|NCT02910089|OG000|Outcome|Shared Decision Making/Brief Negotiated Interviewing|This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
11288277|NCT02910089|OG001|Outcome|Control Arm|Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
11288278|NCT02910089|EG000|Reported Event|Shared Decision Making/Brief Negotiated Interviewing|This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
11288279|NCT02910089|EG001|Reported Event|Control Arm|Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
11288280|NCT02910102|BG000|Baseline|Sequence 1: AB|"RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II~Placebo in Period IV"
10970751|NCT00912015|BG000|Baseline|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970752|NCT00912015|BG001|Baseline|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288281|NCT02910102|BG001|Baseline|Sequence 2: BA|"Placebo: once daily, oral, matching tablets in Period II~RVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV"
11288282|NCT02910102|BG002|Baseline|Total|Total of all reporting groups
10970753|NCT00912015|BG002|Baseline|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970754|NCT00912015|BG003|Baseline|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970755|NCT00912015|BG004|Baseline|Total|Total of all reporting groups
10970756|NCT00912015|FG000|Participant Flow|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970757|NCT00912015|FG001|Participant Flow|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970758|NCT00912015|FG002|Participant Flow|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288283|NCT02910102|FG000|Participant Flow|Sequence 1: AB|"RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II~Placebo in Period IV"
11288284|NCT02910102|FG001|Participant Flow|Sequence 2: BA|"Placebo: once daily, oral, matching tablets in Period II~RVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV"
11288285|NCT02910102|OG000|Outcome|RVT-101 35 mg|Subjects who dosed with RVT-101 in both sequences (AB and BA) are included in this analysis
11288286|NCT02910102|OG001|Outcome|Placebo|Subjects who dosed with Placebo in both sequences (AB and BA) are included in this analysis
11288287|NCT02910102|OG000|Outcome|RVT-101 35 mg|"RVT-101 35 mg: once daily, oral~Subjects who dosed with RVT-101 in both sequences (AB and BA) are included in this analysis"
11288288|NCT02910102|EG000|Reported Event|RVT-101 35 mg|Subjects who dosed with RVT-101 in both sequences (AB and BA) are included
11288289|NCT02910102|EG001|Reported Event|Placebo|Subjects who dosed with Placebo in both sequences (AB and BA) are included
11288290|NCT02910102|EG002|Reported Event|Screening Period|Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)
11288291|NCT02910102|EG003|Reported Event|Run-In Period|Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 2 weeks)
11288292|NCT02910102|EG004|Reported Event|RVT-101 Post-Treatment|Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose
11288293|NCT02910102|EG005|Reported Event|Placebo Post-Treatment|Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose
11288294|NCT02910167|BG000|Baseline|Buscapina Compositum N|Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).
11288295|NCT02910167|FG000|Participant Flow|Buscapina Compositum N|Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).
11288296|NCT02910167|OG000|Outcome|Buscapina Compositum N|Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).
11288297|NCT02910167|EG000|Reported Event|Buscapina Compositum N|Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).
11288298|NCT02910362|BG000|Baseline|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
11288299|NCT02910362|BG001|Baseline|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
11288300|NCT02910362|BG002|Baseline|Total|Total of all reporting groups
11288301|NCT02910362|FG000|Participant Flow|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
11288302|NCT02910362|FG001|Participant Flow|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
11288303|NCT02910362|OG000|Outcome|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
11288304|NCT02910362|OG001|Outcome|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
11288305|NCT02910362|EG000|Reported Event|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment~Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
11288306|NCT02910362|EG001|Reported Event|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment~AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
11288307|NCT02910466|BG000|Baseline|rhPTH(1-84)|Participants received 25 micrograms (mcg) of rhPTH(1-84) with an upwards increments to 50, 75, and 100 mcg subcutaneous (SC) injection to the thigh via a multi-dose pen injector device once daily for 36 months of treatment period. The dose of rhPTH(1 84) was individualized based on albumin-corrected serum calcium (ACSC) and 24-hour calcium urinary excretion at investigator's discretion to achieve a serum calcium level in the lower half of the normal range (8 and 9 milligram/deciliter [mg/dL]).
11288308|NCT02910466|FG000|Participant Flow|rhPTH(1-84)|Participants received 25 micrograms (mcg) of rhPTH(1-84) with an upwards increments to 50, 75, and 100 mcg subcutaneous (SC) injection to the thigh via a multi-dose pen injector device once daily for 36 months of treatment period. The dose of rhPTH(1 84) was individualized based on albumin-corrected serum calcium (ACSC) and 24-hour calcium urinary excretion at investigator's discretion to achieve a serum calcium level in the lower half of the normal range (8 and 9 milligram/deciliter [mg/dL]).
11288309|NCT02910466|OG000|Outcome|rhPTH(1-84)|Participants received 25 micrograms (mcg) of rhPTH(1-84) with an upwards increments to 50, 75, and 100 mcg subcutaneous (SC) injection to the thigh via a multi-dose pen injector device once daily for 36 months of treatment period. The dose of rhPTH(1 84) was individualized based on albumin-corrected serum calcium (ACSC) and 24-hour calcium urinary excretion at investigator's discretion to achieve a serum calcium level in the lower half of the normal range (8 and 9 milligram/deciliter [mg/dL]).
11288310|NCT02910466|EG000|Reported Event|rhPTH(1-84)|Participants received 25 micrograms (mcg) of rhPTH(1-84) with an upwards increments to 50, 75, and 100 mcg subcutaneous (SC) injection to the thigh via a multi-dose pen injector device once daily for 36 months of treatment period. The dose of rhPTH(1 84) was individualized based on albumin-corrected serum calcium (ACSC) and 24-hour calcium urinary excretion at investigator's discretion to achieve a serum calcium level in the lower half of the normal range (8 and 9 milligram/deciliter [mg/dL]).
11288311|NCT02910674|BG000|Baseline|Diabetes (Type I or II), Ages 13-80|Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
11288312|NCT02910674|FG000|Participant Flow|Diabetes (Type I or II), Ages 13-80|Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
11288313|NCT02910674|OG000|Outcome|Diabetes (Type I or II), Ages 13-80|Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
11288314|NCT02910674|OG000|Outcome|One Arm|"This is a comparative diagnostic study, no interventional actions are being taken.~Dario Blood Glucose Monitoring System: Accuracy with usability assessment"
10842410|NCT00246337|EG000|Reported Event|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
11288315|NCT02910674|EG000|Reported Event|Diabetes (Type I or II), Ages 13-80|Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
11288316|NCT02910713|BG000|Baseline|All Participants|Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure. Randomization determined the order of intranasal or extranasal application.
11332447|NCT03495908|FG001|Participant Flow|VGo With Rapid Acting Insulin|Continue on U-100 Rapid Acting Insulin (RAI) delivered by the V-Go insulin delivery device.
10842411|NCT00246337|EG001|Reported Event|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11288317|NCT02910713|FG000|Participant Flow|All Participants|Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥ 3 at 2 or more consecutive time points in at least one eye during controlled adverse environment (CAE) exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure. Randomization determined the order of intranasal or extranasal application.
11288318|NCT02910713|OG000|Outcome|Intranasal Application|Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.
11288319|NCT02910713|OG001|Outcome|Extranasal Application|Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.
11288320|NCT02910713|EG000|Reported Event|All Participants|Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure. Randomization determined the order of intranasal or extranasal application.
11288321|NCT02910739|BG000|Baseline|Part I: MK-8931 40 mg in Moderate HI Participants|Single oral dose of MK-8931 (40 mg tablet) in participants with moderate HI in fasted state (Part I)
11288322|NCT02910739|BG001|Baseline|Part I: MK-8931 40 mg in Healthy Participants|Single oral dose of MK-8931 (40 mg tablet) in healthy matched participants in fasted state (Part I)
11288323|NCT02910739|BG002|Baseline|Total|Total of all reporting groups
11288324|NCT02910739|FG000|Participant Flow|Part I: MK-8931 40 mg in Moderate HI Participants|Single oral dose of MK-8931 (40 mg tablet) in participants with moderate Hepatic Insufficiency (HI) in fasted state (Part I)
11288325|NCT02910739|FG001|Participant Flow|Part I: MK-8931 40 mg in Healthy Participants|Single oral dose of MK-8931 (40 mg tablet) in healthy matched participants in fasted state (Part I)
11288326|NCT02910739|FG002|Participant Flow|Part II: MK-8931 40 mg in Mild HI Participants|Single oral dose of MK-8931 (40 mg tablet) in participants with mild HI in fasted state (Part II)
11288327|NCT02910739|FG003|Participant Flow|Part II: MK-8931 40 mg in Healthy Participants|Single oral dose of MK-8931 (40 mg tablet) in healthy matched participants in fasted state (Part II)
11288328|NCT02910739|OG000|Outcome|Part I: MK-8931 40 mg in Moderate HI Participants|Single oral dose of MK-8931 (40 mg tablet) in participants with moderate HI in fasted state (Part I)
11288329|NCT02910739|OG001|Outcome|Part I: MK-8931 40 mg in Healthy Participants|Single oral dose of MK-8931 (40 mg tablet) in healthy matched participants in fasted state (Part I)
11288330|NCT02910739|EG000|Reported Event|Part I: MK-8931 40 mg in Moderate HI Participants|Single oral dose of MK-8931 (40 mg tablet) in participants with moderate HI in fasted state (Part I)
11288331|NCT02910739|EG001|Reported Event|Part I: MK-8931 40 mg in Healthy Participants|Single oral dose of MK-8931 (40 mg tablet) in healthy matched participants in fasted state (Part I)
11288332|NCT02911025|BG000|Baseline|Patients Treated With Clobazam|Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
11288333|NCT02911025|FG000|Participant Flow|Patients Treated With Clobazam|Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
11288334|NCT02911025|OG000|Outcome|Patients Treated With Clobazam|Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
11288335|NCT02911025|EG000|Reported Event|Patients Treated With Clobazam|Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
11288336|NCT02911116|BG000|Baseline|Cohort 1 (Subcutaneous Only)|"Subcutaneous injections of Ustekinumab at baseline.~Ustekinumab: Subcutaneous Injection"
11288337|NCT02911116|BG001|Baseline|Cohort 2 (IV and Subcutaneous)|"Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.~Ustekinumab: Subcutaneous Injection~Ustekinumab: Intravenous Infusion"
11288338|NCT02911116|BG002|Baseline|Total|Total of all reporting groups
11288339|NCT02911116|FG000|Participant Flow|Cohort 1 (Subcutaneous Only)|"Subcutaneous injections of Ustekinumab at baseline.~Ustekinumab: Subcutaneous Injection"
11288340|NCT02911116|FG001|Participant Flow|Cohort 2 (IV and Subcutaneous)|"Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.~Ustekinumab: Subcutaneous Injection~Ustekinumab: Intravenous Infusion"
11288341|NCT02911116|OG000|Outcome|Cohort 1 (Subcutaneous Only)|"Subcutaneous injections of Ustekinumab at baseline.~Ustekinumab: Subcutaneous Injection"
11332448|NCT03495908|OG000|Outcome|VGo With Regular Human Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
11332449|NCT03495908|OG001|Outcome|VGo With Rapid Acting Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
11332450|NCT03495908|EG000|Reported Event|VGo With Regular Human Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
10842412|NCT00246337|EG002|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11288342|NCT02911116|OG001|Outcome|Cohort 2 (IV and Subcutaneous)|"Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.~Ustekinumab: Subcutaneous Injection~Ustekinumab: Intravenous Infusion"
11288343|NCT02911116|EG000|Reported Event|Cohort 1 (Subcutaneous Only)|"Subcutaneous injections of Ustekinumab at baseline.~Ustekinumab: Subcutaneous Injection"
11288344|NCT02911116|EG001|Reported Event|Cohort 2 (IV and Subcutaneous)|"Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.~Ustekinumab: Subcutaneous Injection~Ustekinumab: Intravenous Infusion"
11288345|NCT02911285|BG000|Baseline|N-acetylcysteine + Cognitive Behavioral Therapy|"Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg bid (2400mg/day)~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288346|NCT02911285|BG001|Baseline|Placebo + Cognitive Behavioral Therapy|"Participants received placebo pills and CBT for 8 weeks.~Placebo: Placebo pills bid~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288347|NCT02911285|BG002|Baseline|Total|Total of all reporting groups
11288348|NCT02911285|FG000|Participant Flow|N-acetylcysteine (NAC) Plus Cognitive Behavioral Therapy (CBT)|"Participants randomized to N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg bid (2400mg/day)~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288349|NCT02911285|FG001|Participant Flow|Placebo + Cognitive Behavioral Therapy (CBT)|"Participants received placebo pills and Cognitive Behavioral Therapy (CBT) for 8 weeks.~Placebo: Placebo pills bid~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288350|NCT02911285|OG000|Outcome|N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)|"Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg twice per day (2400mg/day)~Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week"
11288351|NCT02911285|OG001|Outcome|Placebo and Cognitive Behavioral Therapy (CBT)|"Participants received placebo pills and CBT for 8 weeks.~Placebo: Placebo pills twice per day~Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week"
11288352|NCT02911285|OG000|Outcome|N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)|"Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg bid (2400mg/day)~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288353|NCT02911285|OG001|Outcome|Placebo and Cognitive Behavioral Therapy (CBT)|"Participants received placebo pills and CBT for 8 weeks.~Placebo: Placebo pills bid~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288354|NCT02911285|OG000|Outcome|N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)|"Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg twice per day (2400mg/day)~Cognitive behavioral therapy for alcohol/substance use disorder, one hour/once a week"
11288355|NCT02911285|OG001|Outcome|Placebo and Cognitive Behavioral Therapy (CBT)|"Participants received placebo pills and CBT for 8 weeks.~Placebo: Placebo pills twice per day~Cognitive behavioral therapy for alcohol/substance use disorder, one hour/once a week"
11288356|NCT02911285|EG000|Reported Event|N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)|"Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.~N-acetylcysteine: 1200mg bid (2400mg/day)~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288357|NCT02911285|EG001|Reported Event|Placebo and Cognitive Behavioral Therapy (CBT)|"Participants received placebo pills and CBT for 8 weeks.~Placebo: Placebo pills bid~Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week"
11288358|NCT02911324|BG000|Baseline|Nabilone|"Will receive nabilone at 1 mg daily (BID) over 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11288359|NCT02911324|BG001|Baseline|Nabilone and EX/RP|"Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD.~Exposure and Response Prevention Therapy: Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions."
11288360|NCT02911324|BG002|Baseline|Total|Total of all reporting groups
11288361|NCT02911324|FG000|Participant Flow|Nabilone|"Will receive nabilone at 1 mg daily (BID) over 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
10970759|NCT00912015|FG003|Participant Flow|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970760|NCT00912015|OG000|Outcome|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11332451|NCT03495908|EG001|Reported Event|VGo With Rapid Acting Insulin|VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
11332452|NCT03496220|BG000|Baseline|Feedback|"The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~Angulus: Feedback on patient recumbency"
11332453|NCT03496220|BG001|Baseline|No Feedback|"The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
11332454|NCT03496220|BG002|Baseline|Total|Total of all reporting groups
11336290|NCT03565068|OG006|Outcome|Panel A (Healthy Participants): Placebo Monotherapy|Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
11288362|NCT02911324|FG001|Participant Flow|Nabilone and EX/RP|"Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD.~Exposure and Response Prevention Therapy: Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions."
11288363|NCT02911324|OG000|Outcome|Nabilone|"Will receive nabilone at 1 mg daily (BID) over 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11288364|NCT02911324|OG001|Outcome|Nabilone and EX/RP|"Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD.~Exposure and Response Prevention Therapy: Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions."
11288365|NCT02911324|OG000|Outcome|Flow|# of participants enrolled per month
11288366|NCT02911324|EG000|Reported Event|Nabilone|"Will receive nabilone at 1 mg daily (BID) over 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11288367|NCT02911324|EG001|Reported Event|Nabilone and EX/RP|"Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.~Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD.~Exposure and Response Prevention Therapy: Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions."
11288368|NCT02911519|BG000|Baseline|Brief Group Psychoeducation|"Brief Group Psychoeducation: First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: inform duties and rights of the patient and his family in the Colombian health system and administrative procedures related to patient care.~This Brief Group Psychoeducation also received Treatment as Usual."
11288369|NCT02911519|BG001|Baseline|Treatment as Usual Only|"The patients in both arms of the intervention received this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic.~Treatment as Usual: The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months."
11288370|NCT02911519|BG002|Baseline|Total|Total of all reporting groups
11288371|NCT02911519|FG000|Participant Flow|Brief Group Psychoeducation|"Brief Group Psychoeducation: First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: inform duties and rights of the patient and his family in the Colombian health system and administrative procedures related to patient care.~This Brief Group Psychoeducation also received Treatment as Usual."
11332455|NCT03496220|FG000|Participant Flow|ICU A Feedback First, Then no Feedback, and Feedback Last|"During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
10842413|NCT00246337|EG003|Reported Event|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842414|NCT00246337|EG004|Reported Event|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842415|NCT00246337|EG005|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842416|NCT00246337|EG006|Reported Event|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842417|NCT00246337|EG007|Reported Event|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
10842418|NCT00246337|EG008|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
11288372|NCT02911519|FG001|Participant Flow|Treatment as Usual Only|"The patients in both arms of the intervention received this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic.~Treatment as Usual: The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months."
11288373|NCT02911519|OG000|Outcome|Brief Group Psychoeducation|"Brief Group Psychoeducation: First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: inform duties and rights of the patient and his family in the Colombian health system and administrative procedures related to patient care.~This Brief Group Psychoeducation also received Treatment as Usual."
11288374|NCT02911519|OG001|Outcome|Treatment as Usual Only|"The patients in both arms of the intervention received this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic.~Treatment as Usual: The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months."
11288375|NCT02911519|EG000|Reported Event|Brief Group Psychoeducation|"Brief Group Psychoeducation: First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: inform duties and rights of the patient and his family in the Colombian health system and administrative procedures related to patient care.~This Brief Group Psychoeducation also received Treatment as Usual."
11288376|NCT02911519|EG001|Reported Event|Treatment as Usual Only|"The patients in both arms of the intervention received this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic.~Treatment as Usual: The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months."
11288377|NCT02911688|BG000|Baseline|Placebo Then Gamma T|Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks and then gamma tocopherol will be taken as 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses.
11288378|NCT02911688|BG001|Baseline|Gamma Tocopherol Then Placebo|Gamma tocopherol will be taken 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks followed by safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses.
11288379|NCT02911688|BG002|Baseline|Total|Total of all reporting groups
11288380|NCT02911688|FG000|Participant Flow|Placebo Then Gamma T|Participants first received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks. Then they received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses.
11288381|NCT02911688|FG001|Participant Flow|Gamma Tocopherol Then Placebo|Participants first received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses, followed by a washout period of at least 3 weeks. They then received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses.
11288382|NCT02911688|OG000|Outcome|Gamma Tocopherol (N=7)|gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
11288383|NCT02911688|OG001|Outcome|Placebo (N=7)|Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
11288384|NCT02911688|OG000|Outcome|Gamma Tocopherol|gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
11288385|NCT02911688|OG001|Outcome|Placebo|Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
11288386|NCT02911688|EG000|Reported Event|Gamma Tocopherol|gamma tocopherol 1400 mg, taken as 2 700 mg capsules every 12 hours for a total of 4 doses
11288387|NCT02911688|EG001|Reported Event|Placebo|Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
11332456|NCT03496220|FG001|Participant Flow|ICU B No Feedback First, Then Feedback, and No Feedback Last|"During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
10970761|NCT00912015|OG001|Outcome|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288388|NCT02911753|BG000|Baseline|Flavored Water|All participants were advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
11288389|NCT02911753|BG001|Baseline|Mediterranean Lemonade|All participants were advised to consume all of the beverage assigned (Mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
11288390|NCT02911753|BG002|Baseline|Green Tea|All participants were advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
11288391|NCT02911753|BG003|Baseline|Total|Total of all reporting groups
11288392|NCT02911753|FG000|Participant Flow|Mediterranean Lemonade Consumption|"All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288393|NCT02911753|FG001|Participant Flow|Green Tea Consumption|"All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288394|NCT02911753|FG002|Participant Flow|Flavored Water Consumption|"All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288395|NCT02911753|OG000|Outcome|Interest in Participation.|The number of Hispanic adults who contact the researchers and express interest in participation.
11288396|NCT02911753|OG000|Outcome|Study Recruitment: Screened for Eligibility|The number of Hispanic adults screened for eligibility
11288397|NCT02911753|OG000|Outcome|Study Recruitment: Eligibility|The number of Hispanic adults eligible for study inclusion.
11288398|NCT02911753|OG000|Outcome|Study Recruitment: Ineligibility|The number of Hispanic adults ineligible for study inclusion.
11288399|NCT02911753|OG000|Outcome|Enrollment|The number of Hispanic adults enrolled in the study.
11288400|NCT02911753|OG000|Outcome|Retention|Retention will be measured as the number of participants who remain in the study at 6 weeks.
11288401|NCT02911753|OG000|Outcome|Treatment Satisfaction Flavored Water|Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
11288402|NCT02911753|OG001|Outcome|Treatment Satisfaction Mediterranean Lemonade|Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
11288403|NCT02911753|OG002|Outcome|Treatment Satisfaction Green Tea|Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
11288404|NCT02911753|OG000|Outcome|Change in Total Cholesterol Flavored Water|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in total cholesterol.
11288405|NCT02911753|OG001|Outcome|Change in Total Cholesterol Mediterranean Lemonade|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in total cholesterol.
11288406|NCT02911753|OG002|Outcome|Change in Total Cholesterol Green Tea|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in total cholesterol.
11288407|NCT02911753|OG000|Outcome|Change in Fasting Glucose Flavored Water|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in glucose.
11288408|NCT02911753|OG001|Outcome|Change in Fasting Glucose Mediterranean Lemonade|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in glucose.
11288409|NCT02911753|OG002|Outcome|Change in Fasting Glucose Green Tea|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in glucose.
11288410|NCT02911753|OG000|Outcome|Change in Hemoglobin A1C Flavored Water|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
11288411|NCT02911753|OG001|Outcome|Change in Hemoglobin A1c Mediterranean Lemonade|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
11288412|NCT02911753|OG002|Outcome|Change in Hemoglobin A1c Green Tea|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
10970762|NCT00912015|OG002|Outcome|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970763|NCT00912015|OG003|Outcome|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288413|NCT02911753|OG000|Outcome|Change in Body Weight Flavored Water|Body weight was measured on a digital scale to assess change in body weight over the intervention period.
11288414|NCT02911753|OG001|Outcome|Change in Body Weight Mediterranean Lemonade|Body weight was measured on a digital scale to assess change in body weight over the intervention period.
11288415|NCT02911753|OG002|Outcome|Change in Body Weight Green Tea|Body weight was measured on a digital scale to assess change in body weight over the intervention period.
11288416|NCT02911753|EG000|Reported Event|Mediterranean Lemonade Consumption|"All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288417|NCT02911753|EG001|Reported Event|Green Tea Consumption|"All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288418|NCT02911753|EG002|Reported Event|Flavored Water Consumption|"All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.~Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided."
11288419|NCT02911818|BG000|Baseline|CMS-Alone|"Lifestyle counseling, on the visit schedule currently recommended by the CMS.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian."
11288420|NCT02911818|BG001|Baseline|CMS-Liraglutide|"CMS lifestyle counselling plus liraglutide 3.0 mg/d.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection."
11288421|NCT02911818|BG002|Baseline|Multi-Component Intervention|"CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4."
11288422|NCT02911818|BG003|Baseline|Total|Total of all reporting groups
11288423|NCT02911818|FG000|Participant Flow|CMS-Alone|"Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian."
11288424|NCT02911818|FG001|Participant Flow|CMS-Liraglutide|"CMS lifestyle counselling plus liraglutide 3.0 mg/d.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection."
11288425|NCT02911818|FG002|Participant Flow|Multi-Component Intervention|"CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4."
11288426|NCT02911818|FG003|Participant Flow|12-Week Extension Study: Phentermine Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Phentermine 15 MG"
11288427|NCT02911818|FG004|Participant Flow|12-Week Extension Study: Placebo Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Placebo Oral Tablet"
11288428|NCT02911818|OG000|Outcome|CMS-Alone|"Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian."
11288429|NCT02911818|OG001|Outcome|CMS-Liraglutide|"CMS lifestyle counselling plus liraglutide 3.0 mg/d.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection."
11288430|NCT02911818|OG002|Outcome|Multi-Component Intervention|"CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4."
11333862|NCT03520920|OG002|Outcome|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
10842419|NCT00246376|BG000|Baseline|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
10842420|NCT00246376|BG001|Baseline|Group 2: Diet / Exercise|Diet, exercise, and two placebos
10842421|NCT00246376|BG002|Baseline|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
11288431|NCT02911818|OG000|Outcome|12-Week Extension Study: Phentermine Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Phentermine 15 MG"
11288432|NCT02911818|OG001|Outcome|12-Week Extension Study: Placebo Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Placebo Oral Tablet"
11288433|NCT02911818|OG000|Outcome|12-Week Extension Study: Placebo Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Placebo Oral Tablet"
11288434|NCT02911818|OG001|Outcome|12-Week Extension Study: Phentermine Group|"After the 1-year trial, half the participants who elect to join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Phentermine 15 MG"
11288435|NCT02911818|EG000|Reported Event|CMS-Alone|"Lifestyle counseling, as currently recommended by the CMS.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian."
11288436|NCT02911818|EG001|Reported Event|CMS-Liraglutide|"CMS lifestyle counselling plus liraglutide.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection."
11288437|NCT02911818|EG002|Reported Event|Multi-Component Intervention|"CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.~CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4."
11288438|NCT02911818|EG003|Reported Event|12-Week Extension Study: Phentermine Group|"After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.~CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Phentermine 15 MG"
11288439|NCT02911818|EG004|Reported Event|12-Week Extension Study: Placebo Group|"After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.~CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.~Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.~Placebo Oral Tablet"
11288440|NCT02911844|BG000|Baseline|Fulvestrant|"500 mg administered intramuscularly (as two 5 mL injections) on days 0, 14, 28 and 56~Fulvestrant: Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease."
11288441|NCT02911844|FG000|Participant Flow|Fulvestrant|"500 mg administered intramuscularly (as two 5 mL injections) on days 0, 14, 28 and 56~Fulvestrant: Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease."
11288442|NCT02911844|OG000|Outcome|Fulvestrant|"500 mg administered intramuscularly (as two 5 mL injections) on days 0, 14, 28 and 56~Fulvestrant: Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease."
11288443|NCT02911844|EG000|Reported Event|Fulvestrant|"500 mg administered intramuscularly (as two 5 mL injections) on days 0, 14, 28 and 56~Fulvestrant: Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease."
11288444|NCT02911857|BG000|Baseline|TRAPS|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288445|NCT02911857|BG001|Baseline|HIDS/MKD|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288446|NCT02911857|BG002|Baseline|cfFMF|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288447|NCT02911857|BG003|Baseline|Total|Total of all reporting groups
11288448|NCT02911857|FG000|Participant Flow|TRAPS|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288449|NCT02911857|FG001|Participant Flow|HIDS/MKD|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288450|NCT02911857|FG002|Participant Flow|cfFMF|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288451|NCT02911857|OG000|Outcome|TRAPS|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288452|NCT02911857|OG001|Outcome|HIDS/MKD|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288453|NCT02911857|OG002|Outcome|cfFMF|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288454|NCT02911857|EG000|Reported Event|TRAPS|TRAPS
11288455|NCT02911857|EG001|Reported Event|HIDS|HIDS
11288456|NCT02911857|EG002|Reported Event|cfFMF|Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
11288457|NCT02911909|BG000|Baseline|Standard Rehabilitation|"Patients will receive standard post-operative ACL rehabilitation~Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation"
11288458|NCT02911909|BG001|Baseline|Delfi Moderated Blood Flow Restriction|"Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation~Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy."
11288459|NCT02911909|BG002|Baseline|Total|Total of all reporting groups
10822145|NCT00074802|EG001|Reported Event|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
11288460|NCT02911909|FG000|Participant Flow|Standard Rehabilitation|"Patients will receive standard post-operative ACL rehabilitation~Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation"
11288461|NCT02911909|FG001|Participant Flow|Delfi Moderated Blood Flow Restriction|"Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation~Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy."
11288462|NCT02911909|OG000|Outcome|Standard Rehabilitation|"Patients will receive standard post-operative ACL rehabilitation~Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation"
11288463|NCT02911909|OG001|Outcome|Delfi Moderated Blood Flow Restriction|"Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation~Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy."
11288464|NCT02911909|EG000|Reported Event|Standard Rehabilitation|"Patients will receive standard post-operative ACL rehabilitation~Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation"
11288465|NCT02911909|EG001|Reported Event|Delfi Moderated Blood Flow Restriction|"Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation~Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy."
11288466|NCT02911922|BG000|Baseline|Endorectal Balloon - Radiation Therapy|"Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
11288467|NCT02911922|BG001|Baseline|Rectal Spacer - Radiation Therapy|"Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months."
11288468|NCT02911922|BG002|Baseline|Total|Total of all reporting groups
11332457|NCT03496220|FG002|Participant Flow|ICU C: Feedback First, Then No Feedback, and Feedback Last|"During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
11288469|NCT02911922|FG000|Participant Flow|Endorectal Balloon - Radiation Therapy|"Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
11288470|NCT02911922|FG001|Participant Flow|Rectal Spacer - Radiation Therapy|"Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.~Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months."
11288471|NCT02911922|OG000|Outcome|Endorectal Balloon - Radiation Therapy|"Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
11288472|NCT02911922|OG001|Outcome|Rectal Spacer - Radiation Therapy|"Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months."
11288473|NCT02911922|OG000|Outcome|Endorectal Balloon - Radiation Therapy|"Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
11288474|NCT02911922|OG001|Outcome|Rectal Spacer - Radiation Therapy|"Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.~Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months."
11288475|NCT02911922|EG000|Reported Event|Endorectal Balloon - Radiation Therapy|"Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
11288476|NCT02911922|EG001|Reported Event|Rectal Spacer - Radiation Therapy|"Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.~Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months."
10970764|NCT00912015|EG000|Reported Event|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288477|NCT02911948|BG000|Baseline|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288478|NCT02911948|BG001|Baseline|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288479|NCT02911948|BG002|Baseline|Total|Total of all reporting groups
11288480|NCT02911948|FG000|Participant Flow|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288481|NCT02911948|FG001|Participant Flow|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288482|NCT02911948|OG000|Outcome|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288483|NCT02911948|OG001|Outcome|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288484|NCT02911948|EG000|Reported Event|Insulin Degludec/Liraglutide|Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11288485|NCT02911948|EG001|Reported Event|Insulin Degludec|Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
11332458|NCT03496220|OG000|Outcome|Feedback|"The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~Angulus: Feedback on patient recumbency"
11332459|NCT03496220|OG001|Outcome|No Feedback|"The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
10822146|NCT00074815|BG000|Baseline|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
10822147|NCT00074815|BG001|Baseline|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
10822148|NCT00074815|BG002|Baseline|MM Only|Participants will receive medication management only
10970765|NCT00912015|EG001|Reported Event|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288486|NCT02912195|BG000|Baseline|Intravenous Lidocaine|"Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes"
11288487|NCT02912195|BG001|Baseline|Morphine|"ED provider will choose an appropriate dose of intravenous morphine for the patient.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine"
11288488|NCT02912195|BG002|Baseline|Total|Total of all reporting groups
11288489|NCT02912195|FG000|Participant Flow|Intravenous Lidocaine|"Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes"
11288490|NCT02912195|FG001|Participant Flow|Morphine|"ED provider will choose an appropriate dose of intravenous morphine for the patient.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine"
11288491|NCT02912195|OG000|Outcome|Intravenous Lidocaine|"Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes"
11288492|NCT02912195|OG001|Outcome|Morphine|"ED provider will choose an appropriate dose of intravenous morphine for the patient.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine"
11288493|NCT02912195|EG000|Reported Event|Intravenous Lidocaine|"Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes"
11288494|NCT02912195|EG001|Reported Event|Morphine|"ED provider will choose an appropriate dose of intravenous morphine for the patient.~At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.~Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine"
11288495|NCT02912364|BG000|Baseline|All Participants|Participants who received either Eslicarbazepine Acetate (800mg once daily), or Carbamazepine, 400mg twice daily.
11288496|NCT02912364|FG000|Participant Flow|Eslicarbazepine, Then Carbamazepine|Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg once daily). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to receive Carbamazepine, 400mg twice daily.
11288497|NCT02912364|FG001|Participant Flow|Carbamazepine, Then Eslicarbazepine|Healthy adults will be titrated onto Carbamazepine (400mg twice daily). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to Eslicarbazepine Acetate, 800mg daily.
11288498|NCT02912364|OG000|Outcome|Eslicarbazepine|Eslicarbazepine Acetate (800mg once daily).
11288499|NCT02912364|OG001|Outcome|Carbamazepine|Carbamazepine (400mg twice daily).
11288500|NCT02912364|OG000|Outcome|Non-drug Condition Average|Average of scores prior to treatment 1 and treatment 2.
11288501|NCT02912364|OG001|Outcome|Eslicarbazepine|Eslicarbazepine Acetate (800mg once daily).
11288502|NCT02912364|OG002|Outcome|Carbamazepine|Carbamazepine (400mg twice daily).
11288503|NCT02912364|EG000|Reported Event|Eslicarbazepine|Eslicarbazepine Acetate (800mg once daily).
11288504|NCT02912364|EG001|Reported Event|Carbamazepine|Carbamazepine (400mg twice daily).
11288505|NCT02912455|BG000|Baseline|Study Drug (Canagliflozin)|"Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily.~canagliflozin: encapsulated (gelatin capsule)."
10970766|NCT00912015|EG002|Reported Event|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
11288506|NCT02912455|BG001|Baseline|Placebo|"Drug: Placebo (for canagliflozin)~encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose."
11288507|NCT02912455|BG002|Baseline|Total|Total of all reporting groups
11288508|NCT02912455|FG000|Participant Flow|Study Drug (Canagliflozin)|"Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 11).~canagliflozin: encapsulated (gelatin capsule)."
11288509|NCT02912455|FG001|Participant Flow|Placebo|"Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =5).~Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose."
11288510|NCT02912455|OG000|Outcome|Study Drug (Canagliflozin)|"Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).~canagliflozin: encapsulated (gelatin capsule)."
11288511|NCT02912455|OG001|Outcome|Placebo|"Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).~Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose."
11288512|NCT02912455|EG000|Reported Event|Study Drug (Canagliflozin)|"Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).~canagliflozin: encapsulated (gelatin capsule)."
11288513|NCT02912455|EG001|Reported Event|Placebo|"Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).~Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose."
11288514|NCT02912468|BG000|Baseline|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288515|NCT02912468|BG001|Baseline|Dupilumab 300 mg|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288516|NCT02912468|BG002|Baseline|Total|Total of all reporting groups
11288517|NCT02912468|FG000|Participant Flow|Placebo|Placebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose.
11288518|NCT02912468|FG001|Participant Flow|Dupilumab 300 mg|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288519|NCT02912468|OG000|Outcome|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288520|NCT02912468|OG001|Outcome|Dupilumab 300 mg|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288521|NCT02912468|OG000|Outcome|Dupilumab 300 mg|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288522|NCT02912468|EG000|Reported Event|Placebo|Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288523|NCT02912468|EG001|Reported Event|Dupilumab 300 mg|Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
11288524|NCT02912650|BG000|Baseline|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
11288525|NCT02912650|BG001|Baseline|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
11288526|NCT02912650|BG002|Baseline|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
11288527|NCT02912650|BG003|Baseline|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
11288528|NCT02912650|BG004|Baseline|Total|Total of all reporting groups
11288529|NCT02912650|FG000|Participant Flow|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
11288530|NCT02912650|FG001|Participant Flow|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
11288531|NCT02912650|FG002|Participant Flow|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
11288532|NCT02912650|FG003|Participant Flow|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
10822149|NCT00074815|BG003|Baseline|Total|Total of all reporting groups
10970767|NCT00912015|EG003|Reported Event|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
10970768|NCT00912028|BG000|Baseline|Senofilcon A|"contact lens~senofilcon A: contact lens"
11288533|NCT02912650|OG000|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
11288534|NCT02912650|OG001|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
11288535|NCT02912650|OG002|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
11288536|NCT02912650|OG003|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
10822150|NCT00074815|FG000|Participant Flow|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
10822151|NCT00074815|FG001|Participant Flow|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
11288537|NCT02912650|EG000|Reported Event|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
11288538|NCT02912650|EG001|Reported Event|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
11288539|NCT02912650|EG002|Reported Event|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
11288540|NCT02912650|EG003|Reported Event|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
11288541|NCT02913105|BG000|Baseline|LMB763 100 mg|LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288542|NCT02913105|BG001|Baseline|LMB763 50 mg|LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288543|NCT02913105|BG002|Baseline|Pooled Placebo|LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288544|NCT02913105|BG003|Baseline|Total|Total of all reporting groups
11288545|NCT02913105|FG000|Participant Flow|LMB763 100 mg|LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288546|NCT02913105|FG001|Participant Flow|LMB763 50 mg|LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288547|NCT02913105|FG002|Participant Flow|Pooled Placebo|LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288548|NCT02913105|OG000|Outcome|LMB763 100 mg|LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288549|NCT02913105|OG001|Outcome|LMB763 50 mg|LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288550|NCT02913105|OG002|Outcome|Pooled Placebo|LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288551|NCT02913105|OG002|Outcome|Pooled Placebo|LMB763 100 mg or 50 mg matching placebo was self-administered orally once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288552|NCT02913105|EG000|Reported Event|LMB763 100 mg|LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288553|NCT02913105|EG001|Reported Event|LMB763 50 mg|LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288554|NCT02913105|EG002|Reported Event|Pooled Placebo|LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
11288555|NCT02913326|BG000|Baseline|Dabigatran Etexilate|Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks.
11288556|NCT02913326|BG001|Baseline|Warfarin|Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks.
11288557|NCT02913326|BG002|Baseline|Total|Total of all reporting groups
11288558|NCT02913326|FG000|Participant Flow|Dabigatran Etexilate|Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks.
11288559|NCT02913326|FG001|Participant Flow|Warfarin|Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks.
11288560|NCT02913326|OG000|Outcome|Dabigatran Etexilate|Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks.
11288561|NCT02913326|OG001|Outcome|Warfarin|Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks.
11288562|NCT02913326|EG000|Reported Event|Dabigatran Etexilate|Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks.
11288563|NCT02913326|EG001|Reported Event|Warfarin|Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks.
11288564|NCT02913521|BG000|Baseline|Diclofenac Sodium Gel 1%|"Apply 4 g of gel to the knee four times a day~Diclofenac Sodium Gel 1%"
11288565|NCT02913521|BG001|Baseline|Voltaren Gel|"Apply 4 g of gel to the knee four times a day~Voltaren Gel"
11288566|NCT02913521|BG002|Baseline|Placebo|"Apply 4 g of gel to the knee four times a day~Placebo"
11288567|NCT02913521|BG003|Baseline|Total|Total of all reporting groups
11288568|NCT02913521|FG000|Participant Flow|Diclofenac Sodium Gel 1%|"Apply 4 g of gel to the knee four times a day~Diclofenac Sodium Gel 1%"
11288569|NCT02913521|FG001|Participant Flow|Voltaren Gel|"Apply 4 g of gel to the knee four times a day~Voltaren Gel"
11288570|NCT02913521|FG002|Participant Flow|Placebo|"Apply 4 g of gel to the knee four times a day~Placebo"
10970769|NCT00912028|BG001|Baseline|Balafilcon A|"contact lens~balafilcon A: contact lens"
11288571|NCT02913521|OG000|Outcome|Diclofenac Sodium Gel 1%|"Apply 4 g of gel to the knee four times a day~Diclofenac Sodium Gel 1%"
11288572|NCT02913521|OG001|Outcome|Voltaren Gel|"Apply 4 g of gel to the knee four times a day~Voltaren Gel"
11288573|NCT02913521|OG002|Outcome|Placebo|"Apply 4 g of gel to the knee four times a day~Placebo"
11288574|NCT02913521|EG000|Reported Event|Diclofenac Sodium Gel 1%|"Apply 4 g of gel to the knee four times a day~Diclofenac Sodium Gel 1%"
11288575|NCT02913521|EG001|Reported Event|Voltaren Gel|"Apply 4 g of gel to the knee four times a day~Voltaren Gel"
11288576|NCT02913521|EG002|Reported Event|Placebo|"Apply 4 g of gel to the knee four times a day~Placebo"
11288577|NCT02913924|BG000|Baseline|Clonazepam|"Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a fixed flexible dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.~Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial"
11288578|NCT02913924|BG001|Baseline|Placebo|"Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.~Placebo"
11288579|NCT02913924|BG002|Baseline|Total|Total of all reporting groups
11288580|NCT02913924|FG000|Participant Flow|Clonazepam|"Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a fixed flexible dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.~Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial"
11288581|NCT02913924|FG001|Participant Flow|Placebo|"Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.~Placebo"
11288582|NCT02913924|OG000|Outcome|Clonazepam|"Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a fixed flexible dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.~Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial"
11288583|NCT02913924|OG001|Outcome|Placebo|"Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.~Placebo"
11288584|NCT02913924|EG000|Reported Event|Clonazepam|"Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a fixed flexible dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.~Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial"
10970770|NCT00912028|BG002|Baseline|Methafilcon A|"contact lens~methafilcon A: contact lens"
10970771|NCT00912028|BG003|Baseline|Total|Total of all reporting groups
11288585|NCT02913924|EG001|Reported Event|Placebo|"Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.~Placebo"
11288586|NCT02914119|BG000|Baseline|Eligible Patients|"Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.~Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.~Rocuronium~Succinylcholine~Cisatracurium~Mivacurium~Objective neuromuscular monitoring (acceleromyography)~Sugammadex~Neostigmine"
11288587|NCT02914119|FG000|Participant Flow|Eligible Patients|"Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.~Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.~Rocuronium~Succinylcholine~Cisatracurium~Mivacurium~Objective neuromuscular monitoring (acceleromyography)~Sugammadex~Neostigmine"
11288588|NCT02914119|OG000|Outcome|Eligible Patients|"Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.~Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.~Rocuronium~Succinylcholine~Cisatracurium~Mivacurium~Objective neuromuscular monitoring (acceleromyography)~Sugammadex~Neostigmine"
11288589|NCT02914119|EG000|Reported Event|Eligible Patients|"Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.~Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.~Rocuronium~Succinylcholine~Cisatracurium~Mivacurium~Objective neuromuscular monitoring (acceleromyography)~Sugammadex~Neostigmine"
11288590|NCT02914132|BG000|Baseline|Seraph 100 Filter|"Renal replacement patient with bacteremia.~Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia."
11288591|NCT02914132|FG000|Participant Flow|Seraph 100 Filter|"Renal replacement patient with bacteremia.~Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia."
11288592|NCT02914132|OG000|Outcome|Seraph 100 Filter|"Renal replacement patient with bacteremia.~Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia."
11288593|NCT02914132|EG000|Reported Event|Seraph 100 Filter|"Renal replacement patient with bacteremia.~Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia."
11288594|NCT02914184|BG000|Baseline|Liq_A Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
11288595|NCT02914184|BG001|Baseline|Liq_B Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
10822152|NCT00074815|FG002|Participant Flow|MM Only|Participants will receive medication management only
10822153|NCT00074815|OG000|Outcome|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
10822154|NCT00074815|OG001|Outcome|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
10822155|NCT00074815|OG002|Outcome|MM Only|Participants will receive medication management only
10970772|NCT00912028|FG000|Participant Flow|Senofilcon A|"contact lens~senofilcon A: contact lens"
10970773|NCT00912028|FG001|Participant Flow|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
10970774|NCT00912028|FG002|Participant Flow|Balafilcon A|"contact lens~balafilcon A: contact lens"
10970775|NCT00912028|FG003|Participant Flow|Methafilcon A|"contact lens~methafilcon A: contact lens"
10970776|NCT00912028|FG004|Participant Flow|Vifilcon A|"contact lens~vifilcon A: contact lens"
10970777|NCT00912028|OG000|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
10970778|NCT00912028|OG001|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
10970779|NCT00912028|OG002|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
10970780|NCT00912028|EG000|Reported Event|Senofilcon A|"contact lens~senofilcon A: contact lens"
11288596|NCT02914184|BG002|Baseline|Liq_C Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
11288597|NCT02914184|BG003|Baseline|Lyo Control Group|Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
11288598|NCT02914184|BG004|Baseline|Total|Total of all reporting groups
11288599|NCT02914184|FG000|Participant Flow|Liq_A Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
11288600|NCT02914184|FG001|Participant Flow|Liq_B Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
11288601|NCT02914184|FG002|Participant Flow|Liq_C Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
11288602|NCT02914184|FG003|Participant Flow|Lyo Control Group|Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
11288603|NCT02914184|OG000|Outcome|Liq_A Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
11288604|NCT02914184|OG001|Outcome|Liq_B Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
11288605|NCT02914184|OG002|Outcome|Liq_C Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
11288606|NCT02914184|OG000|Outcome|Liq_Pool Group|Subjects who received two doses of PCV-free HRV liquid formulation of pooled lot A, B and C at 6 and 12 weeks of age.
11288607|NCT02914184|OG001|Outcome|Lyo Control Group|Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
11288608|NCT02914184|OG003|Outcome|Lyo Control Group|Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
11288609|NCT02914184|EG000|Reported Event|Liq_A Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
11288610|NCT02914184|EG001|Reported Event|Liq_B Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
11288611|NCT02914184|EG002|Reported Event|Liq_C Group|Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
11288612|NCT02914184|EG003|Reported Event|Lyo Control Group|Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
11288613|NCT02914210|BG000|Baseline|Virtual Physical Therapy|"Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists~Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home"
11288614|NCT02914210|BG001|Baseline|Traditional Physical Therapy|"No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.~No intervention: Traditional physical therapy delivered in clinic or via home-health visits"
11288615|NCT02914210|BG002|Baseline|Total|Total of all reporting groups
11288616|NCT02914210|FG000|Participant Flow|Virtual Physical Therapy|"Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists~Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home"
11288617|NCT02914210|FG001|Participant Flow|Traditional Physical Therapy|"No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.~No intervention: Traditional physical therapy delivered in clinic or via home-health visits"
11288618|NCT02914210|OG000|Outcome|Virtual Physical Therapy|"Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists~Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home"
11288619|NCT02914210|OG001|Outcome|Traditional Physical Therapy|"No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.~No intervention: Traditional physical therapy delivered in clinic or via home-health visits"
11288620|NCT02914210|EG000|Reported Event|Virtual Physical Therapy|"Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists~Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home"
11288621|NCT02914210|EG001|Reported Event|Traditional Physical Therapy|"No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.~No intervention: Traditional physical therapy delivered in clinic or via home-health visits"
11288622|NCT02914236|BG000|Baseline|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
11288623|NCT02914236|FG000|Participant Flow|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
11288624|NCT02914236|OG000|Outcome|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
11288625|NCT02914236|EG000|Reported Event|Vivaer Stylus|"Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
11288626|NCT02914275|BG000|Baseline|Seqirus QIV|Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288627|NCT02914275|BG001|Baseline|Comparator QIV|Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288628|NCT02914275|BG002|Baseline|Total|Total of all reporting groups
11288629|NCT02914275|FG000|Participant Flow|Seqirus QIV|Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288630|NCT02914275|FG001|Participant Flow|Comparator QIV|Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288631|NCT02914275|OG000|Outcome|Seqirus QIV|Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288632|NCT02914275|OG001|Outcome|Comparator QIV|Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288633|NCT02914275|OG000|Outcome|Seqirus QIV Cohort A|Subjects 6 months through 35 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288634|NCT02914275|OG001|Outcome|Seqirus QIV Cohort B|Subjects 36 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288635|NCT02914275|OG002|Outcome|Comparator QIV Cohort A|Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288636|NCT02914275|OG003|Outcome|Comparator QIV Cohort B|Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288637|NCT02914275|EG000|Reported Event|Seqirus QIV|Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
11288638|NCT02914275|EG001|Reported Event|Comparator QIV|Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
11288639|NCT02914457|BG000|Baseline|Electrophysiological Study|"Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.~Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure."
11288640|NCT02914457|FG000|Participant Flow|Electrophysiological Study|"Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.~Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure."
11288641|NCT02914457|OG000|Outcome|Electrophysiological Study|"Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.~Electrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure."
11288642|NCT02914457|EG000|Reported Event|Enrolled Subjects|All patients that signed informed consent will be summarized
11288643|NCT02914509|BG000|Baseline|OTX-TP (Sustained Release Travoprost) Intracanalicular Depot|Three hundred forty eight (348) subjects were randomized to OTX-TP
11288644|NCT02914509|BG001|Baseline|Placebo Vehicle (PV)|Two hundred seventeen (217) subjects were randomized to the PV.
11288645|NCT02914509|BG002|Baseline|Total|Total of all reporting groups
11288646|NCT02914509|FG000|Participant Flow|OTX-TP|Three forty eight (348) subjects were randomized to OTX-TP
11288647|NCT02914509|FG001|Participant Flow|Placebo Vehicle (PV)|Two hundred seventeen (217) subjects were randomized to the PV.
11288648|NCT02914509|OG000|Outcome|OTX-TP (Sustained Release Travoprost) Intracanalicular Depot|Three hundred forty eight (348) subjects were randomized to OTX-TP
11288649|NCT02914509|OG001|Outcome|Placebo Vehicle (PV)|Two hundred seventeen (217) subjects were randomized to the PV.
11288650|NCT02914509|OG000|Outcome|OTX-TP (Sustained Release Travoprost) Intracanalicular Depot|Three hundred forty eight (343) subjects were randomized to OTX-TP
11288651|NCT02914509|OG001|Outcome|Placebo Vehicle (PV)|Two hundred seventeen (211) subjects were randomized to the PV.
11288652|NCT02914509|EG000|Reported Event|OTX-TP (Sustained Release Travoprost) Intracanalicular Depot|Three hundred forty eight (348) subjects were randomized to OTX-TP
11288653|NCT02914509|EG001|Reported Event|Placebo Vehicle (PV)|Two hundred seventeen (217) subjects were randomized to the PV.
11288654|NCT02914522|BG000|Baseline|Induction Study (Cohort A): Filgotinib 200 mg|Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288655|NCT02914522|BG001|Baseline|Induction Study (Cohort A): Filgotinib 100 mg|Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288656|NCT02914522|BG002|Baseline|Induction Study (Cohort A): Placebo|Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288657|NCT02914522|BG003|Baseline|Induction Study (Cohort B): Filgotinib 200 mg|Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288658|NCT02914522|BG004|Baseline|Induction Study (Cohort B): Filgotinib 100 mg|Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288659|NCT02914522|BG005|Baseline|Induction Study (Cohort B): Placebo|Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288660|NCT02914522|BG006|Baseline|Total|Total of all reporting groups
11288661|NCT02914522|FG000|Participant Flow|Induction Study (Cohort A): Filgotinib 200 mg|Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
11288662|NCT02914522|FG001|Participant Flow|Induction Study (Cohort A): Filgotinib 100 mg|Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288663|NCT02914522|FG002|Participant Flow|Induction Study (Cohort A): Placebo|Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288664|NCT02914522|FG003|Participant Flow|Induction Study (Cohort B): Filgotinib 200 mg|Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288665|NCT02914522|FG004|Participant Flow|Induction Study (Cohort B): Filgotinib 100 mg|Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288666|NCT02914522|FG005|Participant Flow|Induction Study (Cohort B): Placebo|Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288667|NCT02914522|FG006|Participant Flow|Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
11288668|NCT02914522|FG007|Participant Flow|Maintenance Study: Placebo From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
10970781|NCT00912028|EG001|Reported Event|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
11288669|NCT02914522|FG008|Participant Flow|Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
11288670|NCT02914522|FG009|Participant Flow|Maintenance Study: Placebo From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
10970782|NCT00912028|EG002|Reported Event|Balafilcon A|"contact lens~balafilcon A: contact lens"
11288671|NCT02914522|FG010|Participant Flow|Maintenance Study: Placebo From Induction Placebo|Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
11288672|NCT02914522|OG000|Outcome|Induction Study (Cohort A): Filgotinib 200 mg|Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288673|NCT02914522|OG001|Outcome|Induction Study (Cohort A): Filgotinib 100 mg|Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288674|NCT02914522|OG002|Outcome|Induction Study (Cohort A): Placebo|Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288675|NCT02914522|OG003|Outcome|Induction Study (Cohort B): Filgotinib 200 mg|Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288676|NCT02914522|OG004|Outcome|Induction Study (Cohort B): Filgotinib 100 mg|Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288677|NCT02914522|OG005|Outcome|Induction Study (Cohort B): Placebo|Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288678|NCT02914522|OG000|Outcome|Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
11288679|NCT02914522|OG001|Outcome|Maintenance Study: Placebo From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
11288680|NCT02914522|OG002|Outcome|Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
11288681|NCT02914522|OG003|Outcome|Maintenance Study: Placebo From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
10822156|NCT00074815|EG000|Reported Event|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
10822157|NCT00074815|EG001|Reported Event|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
11288682|NCT02914522|OG002|Outcome|Induction Study (Cohort B): Filgotinib 200 mg|Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288683|NCT02914522|OG003|Outcome|Induction Study (Cohort B): Filgotinib 100 mg|Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288684|NCT02914522|OG002|Outcome|Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm) who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
11288685|NCT02914522|OG001|Outcome|Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
11288686|NCT02914522|EG000|Reported Event|Induction Study (Cohort A): Filgotinib 200 mg|Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288687|NCT02914522|EG001|Reported Event|Induction Study (Cohort A): Filgotinib 100 mg|Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288688|NCT02914522|EG002|Reported Event|Induction Study (Cohort A): Placebo|Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288689|NCT02914522|EG003|Reported Event|Induction Study (Cohort B): Filgotinib 200 mg|Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288690|NCT02914522|EG004|Reported Event|Induction Study (Cohort B): Filgotinib 100 mg|Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
11288691|NCT02914522|EG005|Reported Event|Induction Study (Cohort B): Placebo|Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
11288692|NCT02914522|EG006|Reported Event|Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
11288693|NCT02914522|EG007|Reported Event|Maintenance Study: Placebo From Induction Filgotinib 200 mg|Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
11332460|NCT03496220|EG000|Reported Event|Feedback|"The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.~Angulus: Feedback on patient recumbency"
11288694|NCT02914522|EG008|Reported Event|Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
11288695|NCT02914522|EG009|Reported Event|Maintenance Study: Placebo From Induction Filgotinib 100 mg|Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
11288696|NCT02914522|EG010|Reported Event|Maintenance Study: Placebo From Induction Placebo|Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
10822158|NCT00074815|EG002|Reported Event|MM Only|Participants will receive medication management only
10822159|NCT00074958|BG000|Baseline|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
11288697|NCT02914548|BG000|Baseline|0.3% OPA-15406|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288698|NCT02914548|BG001|Baseline|1% OPA-15406|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288699|NCT02914548|BG002|Baseline|Placebo|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily."
11288700|NCT02914548|BG003|Baseline|Total|Total of all reporting groups
11288701|NCT02914548|FG000|Participant Flow|0.3% OPA-15406|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288702|NCT02914548|FG001|Participant Flow|1% OPA-15406|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288703|NCT02914548|FG002|Participant Flow|Placebo|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily."
11288704|NCT02914548|OG000|Outcome|0.3% OPA-15406|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288705|NCT02914548|OG001|Outcome|1% OPA-15406|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288706|NCT02914548|OG002|Outcome|Placebo|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily."
11288707|NCT02914548|EG000|Reported Event|0.3% OPA-15406|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288708|NCT02914548|EG001|Reported Event|1% OPA-15406|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily."
11288709|NCT02914548|EG002|Reported Event|Placebo|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily."
11288710|NCT02914795|BG000|Baseline|Non-resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288711|NCT02914795|BG001|Baseline|Resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288712|NCT02914795|BG002|Baseline|Total|Total of all reporting groups
11288713|NCT02914795|FG000|Participant Flow|Non-resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288714|NCT02914795|FG001|Participant Flow|Resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288715|NCT02914795|OG000|Outcome|Non-resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements"
11288716|NCT02914795|OG001|Outcome|Resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements"
10970783|NCT00912028|EG003|Reported Event|Methafilcon A|"contact lens~methafilcon A: contact lens"
11288717|NCT02914795|OG000|Outcome|Non-resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288718|NCT02914795|OG001|Outcome|Resuscitated Myocardial Infarction|"diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria~diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique"
11288719|NCT02914795|EG000|Reported Event|Resuscitated MI|Death within the Observation period of 7 days; n=3
11288720|NCT02914795|EG001|Reported Event|Non Resuscitated MI|Death within the Observation period of 7 days; n=0
11288721|NCT02914834|BG000|Baseline|Device Acupuncture|"Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions~Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session"
11288722|NCT02914834|BG001|Baseline|Non-pain Related Video Health Education|"The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.~Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion."
11288723|NCT02914834|BG002|Baseline|Total|Total of all reporting groups
11288724|NCT02914834|FG000|Participant Flow|Device Acupuncture|"Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions~Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session"
11288725|NCT02914834|FG001|Participant Flow|Non-pain Related Video Health Education|"The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.~Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion."
10822160|NCT00074958|FG000|Participant Flow|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
10822161|NCT00074958|OG000|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
10970784|NCT00912028|EG004|Reported Event|Vifilcon A|"contact lens~vifilcon A: contact lens"
11288726|NCT02914834|OG000|Outcome|Device Acupuncture|"Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions~Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session"
11288727|NCT02914834|OG001|Outcome|Non-pain Related Video Health Education|"The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.~Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion."
11288728|NCT02914834|EG000|Reported Event|Device Acupuncture|"Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions~Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session"
11288729|NCT02914834|EG001|Reported Event|Non-pain Related Video Health Education|"The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.~Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion."
11288730|NCT02915029|BG000|Baseline|Education and Lifestyle Coaching|"Education and life style coaching includes:~education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence~Educational and lifestyle coaching: Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters.~Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month."
11288731|NCT02915029|BG001|Baseline|Usual Care (UC) Control Arm|once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention.
11288732|NCT02915029|BG002|Baseline|Total|Total of all reporting groups
11288733|NCT02915029|FG000|Participant Flow|Education and Lifestyle Coaching|"Education and life style coaching includes:~education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence~Educational and lifestyle coaching: Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters.~Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month."
11288734|NCT02915029|FG001|Participant Flow|Usual Care (UC) Control Arm|once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention.
11288735|NCT02915029|OG000|Outcome|Education and Lifestyle Coaching|"Education and life style coaching includes:~education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence~Educational and lifestyle coaching: Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters.~Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month."
11288736|NCT02915029|OG001|Outcome|Usual Care (UC) Control Arm|once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention.
11288737|NCT02915029|EG000|Reported Event|Educational Intervention|"Education and life style coaching includes:~education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence"
11288738|NCT02915029|EG001|Reported Event|Usual Care - Control|once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention.
11288739|NCT02915159|BG000|Baseline|Abatacept - Double Blind Treatment Period|Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288740|NCT02915159|BG001|Baseline|Placebo - Double Blind Treatment Period|Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
11288741|NCT02915159|BG002|Baseline|Total|Total of all reporting groups
11288742|NCT02915159|FG000|Participant Flow|Abatacept - Double Blind Treatment Period|Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288743|NCT02915159|FG001|Participant Flow|Placebo - Double Blind Treatment Period|Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
11288744|NCT02915159|OG000|Outcome|Abatacept - Double Blind Treatment Period|Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288745|NCT02915159|OG001|Outcome|Placebo - Double Blind Treatment Period|Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
11288746|NCT02915159|OG000|Outcome|Abatacept - Cumulative Open Label Treatment Period|Cumulative Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288747|NCT02915159|OG000|Outcome|Cumulative Treatment Period|Cumulative Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288748|NCT02915159|OG000|Outcome|Cumulative Open Label Treatment Period|Cumulative Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288749|NCT02915159|EG000|Reported Event|Abatacept - Double Blind Treatment Period|Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
11288750|NCT02915159|EG001|Reported Event|Placebo - Double Blind Treatment Period|Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
11288751|NCT02915159|EG002|Reported Event|Abatacept - Open Label Treatment Period|Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
10822162|NCT00074958|EG000|Reported Event|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
10822163|NCT00074984|BG000|Baseline|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
11288752|NCT02915705|BG000|Baseline|Active Control|Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288753|NCT02915705|BG001|Baseline|Burosumab|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288754|NCT02915705|BG002|Baseline|Total|Total of all reporting groups
11288755|NCT02915705|FG000|Participant Flow|Active Control|Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288756|NCT02915705|FG001|Participant Flow|Burosumab|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288757|NCT02915705|OG000|Outcome|Active Control|Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288758|NCT02915705|OG001|Outcome|Burosumab|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288759|NCT02915705|EG000|Reported Event|Oral Phosphate/Active Vitamin D (Treatment Period)|Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64).
11288760|NCT02915705|EG001|Reported Event|Burosumab (Treatment Period)|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64).
11288761|NCT02915705|EG002|Reported Event|Oral Phosphate/Active Vitamin D->Burosumab (Extension Period)|Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288762|NCT02915705|EG003|Reported Event|Burosumab->Burosumab (Treatment Period and Extension Period)|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period.
11288763|NCT02915705|EG004|Reported Event|Total Burosumab (Treatment Period and Extension Period)|Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection at any time during the study.
11288764|NCT02915744|BG000|Baseline|NKTR-102|NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
11288765|NCT02915744|BG001|Baseline|Treatment of Physician's Choice (TPC)|TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
11288766|NCT02915744|BG002|Baseline|Total|Total of all reporting groups
10822164|NCT00074984|BG001|Baseline|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
11288767|NCT02915744|FG000|Participant Flow|NKTR-102|NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
11288768|NCT02915744|FG001|Participant Flow|Treatment of Physician's Choice (TPC)|TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
11288769|NCT02915744|OG000|Outcome|NKTR-102|In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
11288770|NCT02915744|OG001|Outcome|Treatment of Physician's Choice (TPC)|In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
11288771|NCT02915744|OG000|Outcome|NKTR-102|NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
11288772|NCT02915744|OG001|Outcome|Treatment of Physician's Choice (TPC)|TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
10822165|NCT00074984|BG002|Baseline|Total|Total of all reporting groups
10842422|NCT00246376|BG003|Baseline|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
10842423|NCT00246376|BG004|Baseline|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
10842424|NCT00246376|BG005|Baseline|Total|Total of all reporting groups
11288773|NCT02915744|EG000|Reported Event|NKTR-102|In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
11288774|NCT02915744|EG001|Reported Event|Treatment of Physician's Choice (TPC)|In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
11332461|NCT03496220|EG001|Reported Event|No Feedback|"The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.~Angulus: Feedback on patient recumbency"
11288775|NCT02915835|BG000|Baseline|Riociguat|"Riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)~Riociguat: riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)"
11288776|NCT02915835|BG001|Baseline|Placebo|"Matching placebo tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg matching placebo tablet.~Placebo: Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;"
11288777|NCT02915835|BG002|Baseline|Total|Total of all reporting groups
11288778|NCT02915835|FG000|Participant Flow|Riociguat|"Riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)~Riociguat: riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)"
11288779|NCT02915835|FG001|Participant Flow|Placebo|"Matching placebo tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg matching placebo tablet.~Placebo: Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;"
11288780|NCT02915835|OG000|Outcome|Riociguat|"Riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)~Riociguat: riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)"
11288781|NCT02915835|OG001|Outcome|Placebo|"Matching placebo tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg matching placebo tablet.~Placebo: Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;"
11288782|NCT02915835|EG000|Reported Event|Riociguat|"Riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)~Riociguat: riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)"
11288783|NCT02915835|EG001|Reported Event|Placebo|"Matching placebo tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg matching placebo tablet.~Placebo: Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;"
11288784|NCT02915874|BG000|Baseline|Acceptance and Commitment Therapy Behavioral Intervention|"Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:~Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;~Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as I can't take this anymore and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.~Acceptance and Commitment Therapy"
11288785|NCT02915874|BG001|Baseline|Control|Subjects randomized to not receive treatment.
11288786|NCT02915874|BG002|Baseline|Total|Total of all reporting groups
10970785|NCT00912093|BG000|Baseline|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
10970786|NCT00912093|BG001|Baseline|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
10970787|NCT00912093|BG002|Baseline|Randomized-Icatibant (Blinded Treatment)--Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
11332462|NCT03496298|BG000|Baseline|Placebo|Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
11332463|NCT03496298|BG001|Baseline|Efpeglenatide 4 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).
11332464|NCT03496298|BG002|Baseline|Efpeglenatide 6 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
11332465|NCT03496298|BG003|Baseline|Total|Total of all reporting groups
11332466|NCT03496298|FG000|Participant Flow|Placebo|Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).
10970788|NCT00912093|BG003|Baseline|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
10970789|NCT00912093|BG004|Baseline|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
11332467|NCT03496298|FG001|Participant Flow|Efpeglenatide 4 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).
10970790|NCT00912093|BG005|Baseline|Total|Total of all reporting groups
11288787|NCT02915874|FG000|Participant Flow|Acceptance and Commitment Therapy Behavioral Intervention|"Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:~Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;~Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as I can't take this anymore and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.~Acceptance and Commitment Therapy"
11288788|NCT02915874|FG001|Participant Flow|Control|Subjects randomized to not receive treatment.
11288789|NCT02915874|OG000|Outcome|Acceptance and Commitment Therapy Behavioral Intervention|"Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:~Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;~Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as I can't take this anymore and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.~Acceptance and Commitment Therapy"
11288790|NCT02915874|OG001|Outcome|Control|Subjects randomized to not receive treatment.
11288791|NCT02915874|EG000|Reported Event|Acceptance and Commitment Therapy Behavioral Intervention|"Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:~Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;~Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as I can't take this anymore and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.~Acceptance and Commitment Therapy"
11288792|NCT02915874|EG001|Reported Event|Control|Subjects randomized to not receive treatment.
11288793|NCT02915978|BG000|Baseline|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288794|NCT02915978|BG001|Baseline|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288795|NCT02915978|BG002|Baseline|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
11288796|NCT02915978|BG003|Baseline|Total|Total of all reporting groups
11288797|NCT02915978|FG000|Participant Flow|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288798|NCT02915978|FG001|Participant Flow|Lower Dose Fentanyl|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288799|NCT02915978|FG002|Participant Flow|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
11288800|NCT02915978|OG000|Outcome|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288801|NCT02915978|OG001|Outcome|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288802|NCT02915978|OG002|Outcome|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
11288803|NCT02915978|EG000|Reported Event|Higher Dose Fentanyl Sublingual Spray|"Higher dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288804|NCT02915978|EG001|Reported Event|Lower Dose Fentanyl Sublingual Spray|"Lower dose Fentanyl delivered via sublingual spray every 4 hours.~Fentanyl: Fentanyl delivered via sublingual spray"
11288805|NCT02915978|EG002|Reported Event|Placebo|"Placebo (matching Fentany) delivered via sublingual spray every 4 hours.~Placebo: Matching placebo delivered via sublingual spray"
11288806|NCT02916056|BG000|Baseline|Azeliragon 5 mg|Azeliragon (TTP488) 5mg orally once daily
11288807|NCT02916056|FG000|Participant Flow|Azeliragon 5 mg|Azeliragon (TTP488) 5mg orally once daily
11288808|NCT02916056|OG000|Outcome|Azeliragon 5 mg|Azeliragon (TTP488) 5mg orally once daily
11288809|NCT02916056|EG000|Reported Event|Azeliragon 5 mg|Azeliragon (TTP488) 5mg orally once daily
11288810|NCT02916407|BG000|Baseline|Sevoflurane Group|"The patients will maintained general anesthesia with sevoflurane.~Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with sevoflurane 2-3 vol%."
11288811|NCT02916407|BG001|Baseline|Desflurane Group|"The patients will maintained general anesthesia with desflurane.~Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with desflurane 6-7vol%."
11288812|NCT02916407|BG002|Baseline|Total|Total of all reporting groups
11288813|NCT02916407|FG000|Participant Flow|Sevoflurane Group|"The patients will maintained general anesthesia with sevoflurane.~Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with sevoflurane 2-3 vol%."
11288814|NCT02916407|FG001|Participant Flow|Desflurane Group|"The patients will maintained general anesthesia with desflurane.~Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with desflurane 6-7vol%."
11288815|NCT02916407|OG000|Outcome|Sevoflurane Group|"The patients will maintained general anesthesia with sevoflurane.~Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with sevoflurane 2-3 vol%."
11288816|NCT02916407|OG001|Outcome|Desflurane Group|"The patients will maintained general anesthesia with desflurane.~Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with desflurane 6-7vol%."
11288817|NCT02916407|EG000|Reported Event|Sevoflurane Group|"The patients will maintained general anesthesia with sevoflurane.~Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with sevoflurane 2-3 vol%."
11288818|NCT02916407|EG001|Reported Event|Desflurane Group|"The patients will maintained general anesthesia with desflurane.~Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.~General anesthesia will maintained with desflurane 6-7vol%."
11288819|NCT02916433|BG000|Baseline|Usual Care|This group will continue to receive treatments that have already been initiated to manage bronchial secretions.
11288820|NCT02916433|BG001|Baseline|Octreotide|This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
11288821|NCT02916433|BG002|Baseline|Total|Total of all reporting groups
11288822|NCT02916433|FG000|Participant Flow|Usual Care|This group will continue to receive treatments that have already been initiated to manage bronchial secretions.
11288823|NCT02916433|FG001|Participant Flow|Octreotide|"This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.~Octreotide"
11288824|NCT02916433|OG000|Outcome|Usual Care|This patient have received treatments that have already been initiated to manage bronchial secretions. Below are the bronchial secretion rate at 24, 48, 72 hours.
11288825|NCT02916433|OG001|Outcome|Octreotide #1|This patient have received treatments that have already been initiated to manage bronchial secretions. Additionally, this patient received parenteral octreotide. Below are the bronchial secretion rate at 24, 48, 72 hours.
11288826|NCT02916433|OG002|Outcome|Octreotide #2|This patient have received treatments that have already been initiated to manage bronchial secretions. Additionally, this patient received parenteral octreotide. Below are the bronchial secretion rate at 24, 48, 72 hours.
11288827|NCT02916433|OG000|Outcome|Usual Care|This group will continue to receive treatments that have already been initiated to manage bronchial secretions.
11288828|NCT02916433|OG001|Outcome|Octreotide|This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
11288829|NCT02916433|EG000|Reported Event|Usual Care|This group will continue to receive treatments that have already been initiated to manage bronchial secretions.
11288830|NCT02916433|EG001|Reported Event|Octreotide|This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
11288831|NCT02916498|BG000|Baseline|Bipolar Then Alternative Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
11288832|NCT02916498|BG001|Baseline|Alternative Then Bipolar Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days
11288833|NCT02916498|BG002|Baseline|Total|Total of all reporting groups
10822166|NCT00074984|FG000|Participant Flow|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
10822167|NCT00074984|FG001|Participant Flow|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
10822168|NCT00074984|OG000|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
11288834|NCT02916498|FG000|Participant Flow|Bipolar Then Alternative Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
11288835|NCT02916498|FG001|Participant Flow|Alternative Then Bipolar Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field stimulation for 21 days, then bipolar shape stimulation for 21 days
11288836|NCT02916498|OG000|Outcome|Bipolar Then Alternative Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
11288837|NCT02916498|OG001|Outcome|Alternative Then Bipolar Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days
11288838|NCT02916498|EG000|Reported Event|Bipolar Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar field shape stimulation for 21 days
11288839|NCT02916498|EG001|Reported Event|Alternative Field Shape Stimulation|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days
11288840|NCT02916563|BG000|Baseline|Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes|"A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes.~Age of subject is 18 years or older~Able to speak and read English"
11288841|NCT02916563|FG000|Participant Flow|Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes|"A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes.~Age of subject is 18 years or older~Able to speak and read English"
11288842|NCT02916563|OG000|Outcome|Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes|"A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes.~Age of subject is 18 years or older~Able to speak and read English"
11288843|NCT02916563|EG000|Reported Event|Altitude|"Single arm study Blood Glucose Monitoring System Altitude Performance~Blood Glucose Monitoring System Altitude Performance: Performance as assessed against a reference method at an altitude of approximately 10,000 feet."
11288844|NCT02916693|BG000|Baseline|Mirabegron 25 mg to 50 mg Treatment|Single-center, non-randomized, single-arm study Participants received Mirabegron 25 mg for 2 weeks and switched to the 50 mg for 10 weeks
11288845|NCT02916693|FG000|Participant Flow|Mirabegron 25 mg to 50 mg Treatment|Single-center, non-randomized, single-arm study
11288846|NCT02916693|OG000|Outcome|Mirabegron|Baseline IIEF scores of participants
11288847|NCT02916693|OG000|Outcome|Mirabegron|Participants received Mirabegron 25 mg treatment.
11288848|NCT02916693|OG000|Outcome|Mirabegron|Participants received Mirabegron 50 mg treatment.
11288849|NCT02916693|OG000|Outcome|Mirabegron|Baseline score of OAB-q
10970791|NCT00912093|FG000|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
11288850|NCT02916693|OG000|Outcome|Mirabegron|Participants received Mirabegron 50 mg treatment
11288851|NCT02916693|EG000|Reported Event|Mirabegron 25 mg to 50 mg|Single-center, non-randomized, single-arm study Participants received Mirabegron 25 mg for 2 weeks and switched to the 50 mg for 10 weeks.
11288852|NCT02916745|BG000|Baseline|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the intravenous injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.~Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.~Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance."
11288853|NCT02916745|FG000|Participant Flow|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.~Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.~Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance."
11288854|NCT02916745|OG000|Outcome|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.~Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.~Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance."
11288855|NCT02916745|EG000|Reported Event|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.~Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.~Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance."
11288856|NCT02916927|BG000|Baseline|Ketamine IV Infusion|"Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute."
11288857|NCT02916927|BG001|Baseline|Ketamine IV Push|"Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min."
11288858|NCT02916927|BG002|Baseline|Total|Total of all reporting groups
11288859|NCT02916927|FG000|Participant Flow|Ketamine IV Infusion|"Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute."
11288860|NCT02916927|FG001|Participant Flow|Ketamine IV Push|"Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min."
11288861|NCT02916927|OG000|Outcome|Ketamine IV Infusion|"Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute."
11288862|NCT02916927|OG001|Outcome|Ketamine IV Push|"Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min."
11288863|NCT02916927|EG000|Reported Event|Ketamine IV Infusion|"Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute."
11288864|NCT02916927|EG001|Reported Event|Ketamine IV Push|"Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.~Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min."
11288865|NCT02917031|BG000|Baseline|Saxagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one saxagliptin 5 mg tablet and one sitaglipitin placebo capsule administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of saxagliptin was adjusted to one 2.5 mg tablet.
11288866|NCT02917031|BG001|Baseline|Sitagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one sitagliptin 100 mg capsule and one saxagliptin placebo tablet administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of sitagliptin was adjusted to one 50 mg capsule.
11288867|NCT02917031|BG002|Baseline|Placebo|Participants recieved one saxagliptin placebo tablet and one sitagliptin placebo capsule administered orally once daily for a 24-week treatment period as a control.
11288868|NCT02917031|BG003|Baseline|Total|Total of all reporting groups
11288869|NCT02917031|FG000|Participant Flow|Saxagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one saxagliptin 5 mg tablet and one sitaglipitin placebo capsule administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of saxagliptin was adjusted to one 2.5 mg tablet.
11288870|NCT02917031|FG001|Participant Flow|Sitagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one sitagliptin 100 mg capsule and one saxagliptin placebo tablet administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of sitagliptin was adjusted to one 50 mg capsule.
11288871|NCT02917031|FG002|Participant Flow|Placebo|Participants recieved one saxagliptin placebo tablet and one sitagliptin placebo capsule administered orally once daily for a 24-week treatment period as a control.
11288872|NCT02917031|OG000|Outcome|Saxagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one saxagliptin 5 mg tablet and one sitaglipitin placebo capsule administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of saxagliptin was adjusted to one 2.5 mg tablet.
11288873|NCT02917031|OG001|Outcome|Placebo|Participants recieved one saxagliptin placebo tablet and one sitagliptin placebo capsule administered orally once daily for a 24-week treatment period as a control.
11288874|NCT02917031|OG001|Outcome|Sitagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one sitagliptin 100 mg capsule and one saxagliptin placebo tablet administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of sitagliptin was adjusted to one 50 mg capsule.
11288875|NCT02917031|OG002|Outcome|Placebo|Participants recieved one saxagliptin placebo tablet and one sitagliptin placebo capsule administered orally once daily for a 24-week treatment period as a control.
11288876|NCT02917031|EG000|Reported Event|Saxagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one saxagliptin 5 mg tablet and one sitaglipitin placebo capsule administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of saxagliptin was adjusted to one 2.5 mg tablet.
11288877|NCT02917031|EG001|Reported Event|Sitagliptin|Participants with an eGFR ≥50 mL/min/1.73m^2 received one sitagliptin 100 mg capsule and one saxagliptin placebo tablet administered orally once daily for a 24-week treatment period. Participants with an eGFR ≥30 to <50 mL/min/1.73m^2, the dose of sitagliptin was adjusted to one 50 mg capsule.
11288878|NCT02917031|EG002|Reported Event|Placebo|Participants recieved one saxagliptin placebo tablet and one sitagliptin placebo capsule administered orally once daily for a 24-week treatment period as a control.
11288879|NCT02917122|BG000|Baseline|Sertraline + Sham tDCS|"Patients will take sham tDCS.~Sertraline: Patients will take Sertraline.~sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment."
11288880|NCT02917122|BG001|Baseline|Sertraline + Active tDCS|"Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~Sertraline: Patients will take Sertraline."
11288881|NCT02917122|BG002|Baseline|Total|Total of all reporting groups
11288882|NCT02917122|FG000|Participant Flow|Sertraline + Sham tDCS|"Patients will take sham tDCS.~Sertraline: Patients will take Sertraline.~sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment."
11288883|NCT02917122|FG001|Participant Flow|Sertraline + Active tDCS|"Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~Sertraline: Patients will take Sertraline."
11288884|NCT02917122|OG000|Outcome|Sertraline + Sham tDCS|"Patients will take sham tDCS.~Sertraline: Patients will take Sertraline.~sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment."
11288885|NCT02917122|OG001|Outcome|Sertraline + Active tDCS|"Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~Sertraline: Patients will take Sertraline."
11288886|NCT02917122|EG000|Reported Event|Sertraline + Sham tDCS|"Patients will take sham tDCS.~Sertraline: Patients will take Sertraline.~sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment."
11332468|NCT03496298|FG002|Participant Flow|Efpeglenatide 6 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
11332469|NCT03496298|OG000|Outcome|Efpeglenatide 4 mg+6 mg|Included all participants who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).
11332470|NCT03496298|OG001|Outcome|Placebo|Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
11332471|NCT03496298|EG000|Reported Event|Placebo|Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
11288887|NCT02917122|EG001|Reported Event|Sertraline + Active tDCS|"Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.~Sertraline: Patients will take Sertraline."
11288888|NCT02917265|BG000|Baseline|TENS for Vagus Stimulation|"A transcutaneous electrical nerve stimulation (TENS) unit is applied to an area of the external ear that is innervated by the auricular branch of the vagus nerve.~TENS for vagus stimulation: TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve."
11288889|NCT02917265|BG001|Baseline|TENS for Sham Stimulation|"A TENS unit is applied to an area of the external ear that is devoid of vagus innervation.~TENS for sham stimulation: TENS electrodes are applied on an area of the external ear devoid of vagus innervation."
11288890|NCT02917265|BG002|Baseline|Total|Total of all reporting groups
11288891|NCT02917265|FG000|Participant Flow|TENS for Vagus Stimulation|"A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.~TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear."
11288892|NCT02917265|FG001|Participant Flow|TENS for Sham Stimulation|"A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.~TENS for sham stimulation: TENS electrodes are applied on the earlobe."
11288893|NCT02917265|OG000|Outcome|TENS for Vagus Stimulation|"A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.~TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear."
11288894|NCT02917265|OG001|Outcome|TENS for Sham Stimulation|"A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.~TENS for sham stimulation: TENS electrodes are applied on the earlobe."
11288895|NCT02917265|OG000|Outcome|TENS for Vagus Stimulation|"A transcutaneous electrical nerve stimulation (TENS) unit is applied to an area of the external ear that is innervated by the auricular branch of the vagus nerve.~TENS for vagus stimulation: TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve."
11288896|NCT02917265|OG001|Outcome|TENS for Sham Stimulation|"A TENS unit is applied to an area of the external ear that is devoid of vagus innervation.~TENS for sham stimulation: TENS electrodes are applied on an area of the external ear devoid of vagus innervation."
11288897|NCT02917265|EG000|Reported Event|TENS for Vagus Stimulation|"A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.~TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear."
11288898|NCT02917265|EG001|Reported Event|TENS for Sham Stimulation|"A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.~TENS for sham stimulation: TENS electrodes are applied on the earlobe."
11288899|NCT02917278|BG000|Baseline|Meals|"High-protein renal-specific meals~Meals: High Protein renal-specific meals"
11288900|NCT02917278|BG001|Baseline|Control|No Meals
11288901|NCT02917278|BG002|Baseline|Total|Total of all reporting groups
11288902|NCT02917278|FG000|Participant Flow|Meals|"High-protein renal-specific meals~Meals: High Protein renal-specific meals"
11288903|NCT02917278|FG001|Participant Flow|Control|No Meals
11288904|NCT02917278|OG000|Outcome|Meals|"High-protein renal-specific meals~Meals: High Protein renal-specific meals"
11288905|NCT02917278|OG001|Outcome|Control|No Meals
11288906|NCT02917278|EG000|Reported Event|Meals|"High-protein renal-specific meals~Meals: High Protein renal-specific meals"
10970792|NCT00912093|FG001|Participant Flow|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
11288907|NCT02917278|EG001|Reported Event|Control|No Meals
11288908|NCT02917447|BG000|Baseline|DESTRESS-WV|"Tailored online intervention for PTSD for women Veterans with coach support.~DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives.~Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana"
11288909|NCT02917447|BG001|Baseline|Phone Monitoring|"Weekly check-in calls from a study coach.~Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided."
11288910|NCT02917447|BG002|Baseline|Total|Total of all reporting groups
11288911|NCT02917447|FG000|Participant Flow|DESTRESS-WV|"Tailored online intervention for PTSD for women Veterans with coach support.~DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives.~Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana"
11288912|NCT02917447|FG001|Participant Flow|Phone Monitoring|"Weekly check-in calls from a study coach.~Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided."
11288913|NCT02917447|OG000|Outcome|DESTRESS-WV|"Tailored online intervention for PTSD for women Veterans with coach support.~DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives.~Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana"
11288914|NCT02917447|OG001|Outcome|Phone Monitoring|"Weekly check-in calls from a study coach.~Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided."
11288915|NCT02917447|EG000|Reported Event|DESTRESS-WV|"Tailored online intervention for PTSD for women Veterans with coach support.~DESTRESS-WV: This is an online intervention for PTSD tailored for women Veterans with weekly, 15-minute coach calls. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives.~Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress mana"
11288916|NCT02917447|EG001|Reported Event|Phone Monitoring|"Weekly check-in calls from a study coach.~Phone Monitoring: A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided."
11288917|NCT02917603|BG000|Baseline|Intervention|These family members and residents will use web conferencing technology to attend their quarterly care conferences
11288918|NCT02917603|BG001|Baseline|Control|These family and residents will receive usual care
11288919|NCT02917603|BG002|Baseline|Total|Total of all reporting groups
11288920|NCT02917603|FG000|Participant Flow|Intervention|"These family members and residents will use web conferencing technology to attend their quarterly care conferences~Web Conferencing: Individuals will communicate with the nursing home team via web conferencing during quarterly care conference"
11288921|NCT02917603|FG001|Participant Flow|Control|These family and residents will receive usual care
11288922|NCT02917603|OG000|Outcome|Intervention|These family members and residents will use web conferencing technology to attend their quarterly care conferences
11288923|NCT02917603|OG001|Outcome|Control|These family and residents will receive usual care
11288924|NCT02917603|OG000|Outcome|Intervention|"These family members and residents will use web conferencing technology to attend their quarterly care conferences~Web Conferencing: Individuals will communicate with the nursing home team via web conferencing during quarterly care conference"
11288925|NCT02917603|EG000|Reported Event|Intervention|These family members and residents will use web conferencing technology to attend their quarterly care conferences
10970793|NCT00912093|FG002|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
11288926|NCT02917603|EG001|Reported Event|Control|These family and residents will receive usual care
11288927|NCT02917642|BG000|Baseline|Passive Ultrasonic Irrigation Protocol|"ultrasonic activation of antimicrobial solutions~Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file"
11288928|NCT02917642|BG001|Baseline|Non-Ultrasonic Irrigation Protocol|"no-activation of antimicrobial solutions~Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation"
11288929|NCT02917642|BG002|Baseline|Total|Total of all reporting groups
11288930|NCT02917642|FG000|Participant Flow|Passive Ultrasonic Irrigation Protocol|"ultrasonic activation of antimicrobial solutions~Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file"
11288931|NCT02917642|FG001|Participant Flow|Non-Ultrasonic Irrigation Protocol|"no-activation of antimicrobial solutions~Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation"
11288932|NCT02917642|OG000|Outcome|Passive Ultrasonic Irrigation Protocol|"ultrasonic activation of antimicrobial solutions~Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file"
11288933|NCT02917642|OG001|Outcome|Non-Ultrasonic Irrigation Protocol|"no-activation of antimicrobial solutions~Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation"
11288934|NCT02917642|EG000|Reported Event|Passive Ultrasonic Irrigation Protocol|"ultrasonic activation of antimicrobial solutions~Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file"
11288935|NCT02917642|EG001|Reported Event|Non-Ultrasonic Irrigation Protocol|"no-activation of antimicrobial solutions~Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation"
11288936|NCT02917941|BG000|Baseline|Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
11288937|NCT02917941|FG000|Participant Flow|Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
11288938|NCT02917941|OG000|Outcome|Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
11288939|NCT02917941|EG000|Reported Event|Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
11288940|NCT02918071|BG000|Baseline|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11288941|NCT02918071|FG000|Participant Flow|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11288942|NCT02918071|OG000|Outcome|Benra 30mg|Benralizumab administered subcutaneously every 4 weeks
11288943|NCT02918071|EG000|Reported Event|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
11288944|NCT02918097|BG000|Baseline|Lithium Carbonate|"Group Started: Lithium Carbonate (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step.~Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step.~Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step.~Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step.~Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step~Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).~Lithium Carbonate~Sertraline~Nortriptyline~Risperidone"
11288945|NCT02918097|FG000|Participant Flow|Lithium Carbonate|"Group Started: Lithium Carbonate (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step.~Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step.~Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step.~Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step.~Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step~Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).~Lithium Carbonate~Sertraline~Nortriptyline~Risperidone"
11288946|NCT02918097|OG000|Outcome|Lithium Carbonate|"Group Started: Lithium Carbonate (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step.~Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step.~Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step.~Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step.~Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step~Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).~Lithium Carbonate~Sertraline~Nortriptyline~Risperidone"
11288947|NCT02918097|EG000|Reported Event|Lithium Carbonate|"Group Started: Lithium Carbonate (900mg-1500mg)~Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.~First step: Monotherapy with Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step.~Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step.~Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step.~Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step.~Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step~Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).~Lithium Carbonate~Sertraline~Nortriptyline~Risperidone"
11288948|NCT02918266|BG000|Baseline|Part 1: TAK-071 80 mg + Scopolamine 0.5 mg|TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.
11288949|NCT02918266|BG001|Baseline|Part 2: Treatment Sequence ABDEC|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.
11332472|NCT03496298|EG001|Reported Event|Efpeglenatide 4 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).
11332473|NCT03496298|EG002|Reported Event|Efpeglenatide 6 mg|Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
11332474|NCT03496324|BG000|Baseline|Overall Study|"Nurofen for Children® 400 mg/10 mL single-oral dose under fasted and fed conditions.~Algifor® Junior 400 mg/20 mL single-oral dose under fasted and fed conditions."
11288950|NCT02918266|BG002|Baseline|Part 2: Treatment Sequence BCEAD|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.
11288951|NCT02918266|BG003|Baseline|Part 2: Treatment Sequence CDABE|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period
11288952|NCT02918266|BG004|Baseline|Part 2: Treatment Sequence DEBCA|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.
11288953|NCT02918266|BG005|Baseline|Part 2: Treatment Sequence EACDB|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.
11288954|NCT02918266|BG006|Baseline|Part 2: Treatment Sequence ACBED|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.
11288955|NCT02918266|BG007|Baseline|Part 2: Treatment Sequence BDCAE|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period.
11288956|NCT02918266|BG008|Baseline|Part 2: Treatment Sequence CEDBA|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.
11288957|NCT02918266|BG009|Baseline|Part 2: Treatment Sequence DAECB|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.
11288958|NCT02918266|BG010|Baseline|Part 2: Treatment Sequence EBADC|TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.
11288959|NCT02918266|BG011|Baseline|Total|Total of all reporting groups
11288960|NCT02918266|FG000|Participant Flow|Part 1: TAK-071 80 mg + Scopolamine 0.5 mg|TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2.
11288961|NCT02918266|FG001|Participant Flow|Part 2: Treatment Sequence ABDEC|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.
11288962|NCT02918266|FG002|Participant Flow|Part 2: Treatment Sequence BCEAD|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.
10970794|NCT00912093|FG003|Participant Flow|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
11288963|NCT02918266|FG003|Participant Flow|Part 2: Treatment Sequence CDABE|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period
11288964|NCT02918266|FG004|Participant Flow|Part 2: Treatment Sequence DEBCA|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.
11332475|NCT03496324|FG000|Participant Flow|Sequence 1-BACD: Test (Fed) - Nurofen for Children|"B = Nurofen for Children® 400 mg/10 ml (Test fasted)~A = Nurofen for Children® 400 mg/10 ml (Test fed)~C = Algifor® Junior 400 mg/20 ml (Reference fed)~D = Algifor® Junior 400 mg/20 ml (Reference fasted)"
10970795|NCT00912093|FG004|Participant Flow|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
11288965|NCT02918266|FG005|Participant Flow|Part 2: Treatment Sequence EACDB|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.
11288966|NCT02918266|FG006|Participant Flow|Part 2: Treatment Sequence ACBED|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.
11288967|NCT02918266|FG007|Participant Flow|Part 2: Treatment Sequence BDCAE|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period.
11288968|NCT02918266|FG008|Participant Flow|Part 2: Treatment Sequence CEDBA|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.
11288969|NCT02918266|FG009|Participant Flow|Part 2: Treatment Sequence DAECB|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.
11288970|NCT02918266|FG010|Participant Flow|Part 2: Treatment Sequence EBADC|TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.
11288971|NCT02918266|OG000|Outcome|Part 2: Treatment A|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.
11288972|NCT02918266|OG001|Outcome|Part 2: Treatment B|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288973|NCT02918266|OG002|Outcome|Part 2: Treatment C|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288974|NCT02918266|OG003|Outcome|Part 2: Treatment D|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288975|NCT02918266|OG004|Outcome|Part 2: Treatment E|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288976|NCT02918266|OG000|Outcome|Scopolamine 0.5 mg SC + TAK-071 80 mg|TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.
11288977|NCT02918266|OG001|Outcome|Part 2: Treatment A|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.
11288978|NCT02918266|OG002|Outcome|Part 2: Treatment B|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288979|NCT02918266|OG003|Outcome|Part 2: Treatment C|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288980|NCT02918266|OG004|Outcome|Part 2: Treatment D|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288981|NCT02918266|OG005|Outcome|Part 2: Treatment E|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288982|NCT02918266|OG000|Outcome|Part 1: TAK-071 80 mg + Scopolamine 0.5 mg|TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.
11288983|NCT02918266|EG000|Reported Event|Part 1: TAK-071 80 mg + Scopolamine 0.5 mg|TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2.
11288984|NCT02918266|EG001|Reported Event|Part 2: Treatment A|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.
11288985|NCT02918266|EG002|Reported Event|Part 2: Treatment B|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288986|NCT02918266|EG003|Reported Event|Part 2: Treatment C|TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288987|NCT02918266|EG004|Reported Event|Part 2: Treatment D|TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288988|NCT02918266|EG005|Reported Event|Part 2: Treatment E|TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.
11288989|NCT02918279|BG000|Baseline|Liraglutide 3.0 mg|Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288990|NCT02918279|BG001|Baseline|Placebo|Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288991|NCT02918279|BG002|Baseline|Total|Total of all reporting groups
11288992|NCT02918279|FG000|Participant Flow|Liraglutide 3.0 mg|Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by subcutaneous (s.c.; under the skin) injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288993|NCT02918279|FG001|Participant Flow|Placebo|Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288994|NCT02918279|OG000|Outcome|Liraglutide 3.0 mg|Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288995|NCT02918279|OG001|Outcome|Placebo|Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288996|NCT02918279|EG000|Reported Event|Liraglutide 3.0 mg|Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11288997|NCT02918279|EG001|Reported Event|Placebo|Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
11332476|NCT03496324|FG001|Participant Flow|Sequence 2-DCAB: Test (Fasted) - Nurofen for Children|"D = Algifor® Junior 400 mg/20 ml (Reference fasted)~C = Algifor® Junior 400 mg/20 ml (Reference fed)~A = Nurofen for Children® 400 mg/10 ml (Test fed)~B = Nurofen for Children® 400 mg/10 ml (Test fasted)"
11288998|NCT02918318|BG000|Baseline|Esketamine 28 Milligrams (mg)|Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11288999|NCT02918318|BG001|Baseline|Esketamine 56 mg|DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289000|NCT02918318|BG002|Baseline|Esketamine 84 mg|DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289001|NCT02918318|BG003|Baseline|Placebo|DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.
11289002|NCT02918318|BG004|Baseline|Total|Total of all reporting groups
11289003|NCT02918318|FG000|Participant Flow|Esketamine 28 Milligrams (mg)|Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289004|NCT02918318|FG001|Participant Flow|Esketamine 56 mg|DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289005|NCT02918318|FG002|Participant Flow|Esketamine 84 mg|DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289006|NCT02918318|FG003|Participant Flow|Placebo|DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.
11289007|NCT02918318|FG004|Participant Flow|Esketamine: Flexible Dose|OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.
11289008|NCT02918318|OG000|Outcome|Esketamine 28 Milligrams (mg)|Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11332477|NCT03496324|FG002|Participant Flow|Sequence 3-ADBC: Reference (Fed) - Algifor Junior|"A = Nurofen for Children® 400 mg/10 ml (Test fed)~D = Algifor® Junior 400 mg/20 ml (Reference fasted)~B = Nurofen for Children® 400 mg/10 ml (Test fasted)~C = Algifor® Junior 400 mg/20 ml (Reference fed)"
11332478|NCT03496324|FG003|Participant Flow|Sequence 4-CBDA: Reference (Fasted) - Algifor Junior|"C = Algifor® Junior 400 mg/20 ml (Reference fed)~B = Nurofen for Children® 400 mg/10 ml (Test fasted)~D = Algifor® Junior 400 mg/20 ml (Reference fasted)~A = Nurofen for Children® 400 mg/10 ml (Test fed)"
11332479|NCT03496324|OG000|Outcome|Test (Fasted): Nurofen for Children|"Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Nurofen for Children®: Nurofen for Children® 400 mg/10 ml"
11289009|NCT02918318|OG001|Outcome|Esketamine 56 mg|DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289010|NCT02918318|OG002|Outcome|Esketamine 84 mg|DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.
11289011|NCT02918318|OG003|Outcome|Placebo|DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had >=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.
11289012|NCT02918318|OG000|Outcome|Esketamine: Flexible Dose|OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.
11289013|NCT02918318|EG000|Reported Event|Double Blind (DB): Esketamine 28 mg|Participants received intranasal esketamine 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase.
11289014|NCT02918318|EG001|Reported Event|DB: Esketamine 56 mg|Participants received intranasal esketamine 56 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk DB induction phase.
11289015|NCT02918318|EG002|Reported Event|DB: Esketamine 84 mg|Participants received intranasal esketamine 84 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase.
11289016|NCT02918318|EG003|Reported Event|DB: Placebo|Participants received intranasal placebo twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received dose of internasal placebo during DB induction phase.
11289017|NCT02918318|EG004|Reported Event|DB Follow Up (FU): Esketamine 28 mg|Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD for 4 weeks. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.
11289018|NCT02918318|EG005|Reported Event|DB FU: Esketamine 56 mg|Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.
11289019|NCT02918318|EG006|Reported Event|DB FU: Esketamine 84 mg|Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.
11289020|NCT02918318|EG007|Reported Event|DB FU: Placebo|Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.
11289021|NCT02918318|EG008|Reported Event|Post-Treatment (PT) Phase: Esketamine 28 mg|Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.
11289022|NCT02918318|EG009|Reported Event|PT Phase: Esketamine 56 mg|Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.
11289023|NCT02918318|EG010|Reported Event|PT Phase: Esketamine 84 mg|Participants who were responders at the end of DB induction phase and entered in the PT phase received only an oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.
11289024|NCT02918318|EG011|Reported Event|PT Phase: Placebo|Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.
11289025|NCT02918318|EG012|Reported Event|Open-Label (OL): Flexible Esketamine|Participants received flexible esketamine add-on to an oral AD during OL induction phase for 4 weeks. Analysis was performed on safety analysis set- All participants who received at least 1 dose of flexible Esk during OL induction phase.
11289026|NCT02918318|EG013|Reported Event|OL FU: Flexible Esketamine|Participants who received flexible esketamine add-on to an oral AD during OL induction phase were followed for 4 weeks in OL FU phase. Analysis was performed on follow-up analysis set- all participants who entered the OL follow-up phase and were evaluated for the safety.
10970796|NCT00912093|OG000|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
11289027|NCT02918357|BG000|Baseline|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289028|NCT02918357|FG000|Participant Flow|Ga-68 Labeled PSMA-11 Positron Emission Tomography (PET)|"Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289029|NCT02918357|OG000|Outcome|Pet Positive (Per Patient)|Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy
11289030|NCT02918357|OG000|Outcome|Pet Positive (Per Region)|Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy
11289031|NCT02918357|OG000|Outcome|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289032|NCT02918357|OG000|Outcome|PSA <0.5|Patients whom have a PSA nadir value of <0.5
11289033|NCT02918357|OG001|Outcome|PSA 0.5 - <1.0|Patients whom have a PSA nadir value of 0.5 to <1.0
11289034|NCT02918357|OG002|Outcome|PSA 1.0 - <2.0|Patients whom have a PSA nadir value of 1.0 to <2.0
11289035|NCT02918357|OG003|Outcome|PSA 2.0 - <5.0|Patients whom have a PSA nadir value of 2.0 - <5.0
11289036|NCT02918357|OG004|Outcome|PSA ≥5.0|Patients whom have a PSA nadir value of ≥5.0
11289037|NCT02918357|OG000|Outcome|Prostate Bed|Patients who have the prostate bed included in their study scan
11289038|NCT02918357|OG001|Outcome|Pelvic Nodes|Patients who have the pelvic nodes included in their study scan
11289039|NCT02918357|OG002|Outcome|Extrapelvic Soft Tissue|Patients who have the extrapelvic soft tissue included in their study scan
11289040|NCT02918357|OG003|Outcome|Bone|Patients who have the pelvic bone included in their study scan
11289041|NCT02918357|OG000|Outcome|Ga-68 Labeled PSMA-11 PET|Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
11289042|NCT02918357|OG000|Outcome|Pre-Infusion Heart Rate|All patients were assessed for safety measures that included Heart Rate before infusion
11289043|NCT02918357|OG001|Outcome|Post-Infusion Heart Rate|All patients were assessed for safety measures that included Heart Rate after infusion
11289044|NCT02918357|OG002|Outcome|Absolute Change in Heart Rate|All subjects had the absolute mean in heart rate calculated to assess for safety
11289045|NCT02918357|OG000|Outcome|Pre-Injection|All patients were assessed for safety measures that included blood pressure before infusion
11289046|NCT02918357|OG001|Outcome|Post-Injection|All patients were assessed for safety measures that included blood pressure after infusion
11289047|NCT02918357|OG002|Outcome|Absolute Mean Change|All subjects had the absolute mean in blood pressure calculated to assess for safety
11289048|NCT02918357|EG000|Reported Event|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289049|NCT02918396|BG000|Baseline|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289050|NCT02918396|BG001|Baseline|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289051|NCT02918396|BG002|Baseline|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289052|NCT02918396|BG003|Baseline|Total|Total of all reporting groups
11332480|NCT03496324|OG001|Outcome|Test (Fed): Nurofen for Children|"Nurofen for Children® 400 mg/10 ml by mouth under fed condition~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Nurofen for Children®: Nurofen for Children® 400 mg/10 ml"
10970797|NCT00912093|OG001|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
11289053|NCT02918396|FG000|Participant Flow|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289054|NCT02918396|FG001|Participant Flow|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289055|NCT02918396|FG002|Participant Flow|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289056|NCT02918396|OG000|Outcome|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289057|NCT02918396|OG001|Outcome|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289058|NCT02918396|OG002|Outcome|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289059|NCT02918396|EG000|Reported Event|Conventional PVI|"Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.~Conventional PVI by Radio-frequency Ablation: Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289060|NCT02918396|EG001|Reported Event|PVI + Scar-based Ablation|"Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.~Scar-Based Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11289061|NCT02918396|EG002|Reported Event|PVI + Modeling-predicted Rotors Ablation|"Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.~Rotor Anchors Radio-frequency Ablation: Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation."
11332481|NCT03496324|OG002|Outcome|Reference (Fasted): Algifor Junior|"Algifor® Junior 400 mg/20 ml by mouth under fasted condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Algifor® Junior: Algifor® Junior 400 mg/20 ml"
11332482|NCT03496324|OG003|Outcome|Reference (Fed): Algifor Junior|"Algifor® Junior 400 mg/20 ml by mouth under fed condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Algifor® Junior: Algifor® Junior 400 mg/20 ml"
11332483|NCT03496324|EG000|Reported Event|Test (Fasted): Nurofen for Children|"Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Nurofen for Children®: Nurofen for Children® 400 mg/10 ml"
11332484|NCT03496324|EG001|Reported Event|Test (Fed): Nurofen for Children|"Nurofen for Children® 400 mg/10 ml by mouth under fed condition~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Nurofen for Children®: Nurofen for Children® 400 mg/10 ml"
11289062|NCT02918552|BG000|Baseline|Sodium Nitrite|"20 or 40 mg sodium nitrite tid~sodium nitrite: Subjects to receive active study drug three times daily during treatment period and then post treatment testing period."
11289063|NCT02918552|BG001|Baseline|Placebo|"20 or 40 mg placebo tid~Control: Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period."
11289064|NCT02918552|BG002|Baseline|Total|Total of all reporting groups
11289065|NCT02918552|FG000|Participant Flow|Sodium Nitrite|"20 or 40 mg sodium nitrite tid~sodium nitrite: Subjects to receive active study drug three times daily during treatment period and then post treatment testing period."
11289066|NCT02918552|FG001|Participant Flow|Placebo|"20 or 40 mg placebo tid~Control: Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period."
11289067|NCT02918552|OG000|Outcome|Sodium Nitrite|"20 or 40 mg sodium nitrite tid~sodium nitrite: Subjects to receive active study drug three times daily during treatment period and then post treatment testing period."
11289068|NCT02918552|OG001|Outcome|Placebo|"20 or 40 mg placebo tid~Control: Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period."
11289069|NCT02918552|EG000|Reported Event|Treatment Arm|"20 or 40 mg sodium nitrite tid~sodium nitrite: Subjects to receive active study drug three times daily during treatment period and then post treatment testing period."
11289070|NCT02918552|EG001|Reported Event|Control Arm|"20 or 40 mg placebo tid~Control: Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period."
11289071|NCT02918617|BG000|Baseline|Control Toothpaste Containing Novamin® Technology|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing Novamin® technology"
11289072|NCT02918617|BG001|Baseline|Control Toothpaste Containing 1500 Ppm Fluoride as MFP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing 1500 ppm fluoride as MFP"
11289073|NCT02918617|BG002|Baseline|Test Toothpaste With Nano-HAP (High Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (high concentration)"
11289074|NCT02918617|BG003|Baseline|Test Toothpaste With Nano-HAP (Low Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (low concentration)"
11289075|NCT02918617|BG004|Baseline|Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP and KNO3"
11289076|NCT02918617|BG005|Baseline|Control Toothpaste Without Nano-HAP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste without nano-HAP"
11289077|NCT02918617|BG006|Baseline|Test Toothpaste With Nano-HAP (Medium Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (medium concentration)"
11289078|NCT02918617|BG007|Baseline|Test Cream With Nano-HAP (Higher Concentration)|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Test cream with nano-HAP (higher concentration)"
11289079|NCT02918617|BG008|Baseline|Control Cream Without Nano-HAP|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Control cream without nano-HAP"
11289080|NCT02918617|BG009|Baseline|Total|Total of all reporting groups
11289081|NCT02918617|FG000|Participant Flow|Control Toothpaste Containing Novamin® Technology|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing Novamin® technology"
11289082|NCT02918617|FG001|Participant Flow|Control Toothpaste Containing 1500 Ppm Fluoride as MFP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing 1500 ppm fluoride as MFP"
11332485|NCT03496324|EG002|Reported Event|Reference (Fasted): Algifor Junior|"Algifor® Junior 400 mg/20 ml by mouth under fasted condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Algifor® Junior: Algifor® Junior 400 mg/20 ml"
11289083|NCT02918617|FG002|Participant Flow|Test Toothpaste With Nano-HAP (High Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (high concentration)"
11289084|NCT02918617|FG003|Participant Flow|Test Toothpaste With Nano-HAP (Low Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (low concentration)"
11289085|NCT02918617|FG004|Participant Flow|Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP and KNO3"
11289086|NCT02918617|FG005|Participant Flow|Control Toothpaste Without Nano-HAP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste without nano-HAP"
11289087|NCT02918617|FG006|Participant Flow|Test Toothpaste With Nano-HAP (Medium Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (medium concentration)"
11289088|NCT02918617|FG007|Participant Flow|Test Cream With Nano-HAP (Higher Concentration)|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Test cream with nano-HAP (higher concentration)"
11289089|NCT02918617|FG008|Participant Flow|Control Cream Without Nano-HAP|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Control cream without nano-HAP"
11289090|NCT02918617|OG000|Outcome|Control Toothpaste Containing Novamin® Technology|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing Novamin® technology"
11289091|NCT02918617|OG001|Outcome|Control Toothpaste Containing 1500 Ppm Fluoride as MFP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing 1500 ppm fluoride as MFP"
11289092|NCT02918617|OG002|Outcome|Test Toothpaste With Nano-HAP (High Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (high concentration)"
11289093|NCT02918617|OG003|Outcome|Test Toothpaste With Nano-HAP (Low Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (low concentration)"
11289094|NCT02918617|OG004|Outcome|Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP and KNO3"
11289095|NCT02918617|OG005|Outcome|Control Toothpaste Without Nano-HAP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste without nano-HAP"
11289096|NCT02918617|OG006|Outcome|Test Toothpaste With Nano-HAP (Medium Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (medium concentration)"
11332486|NCT03496324|EG003|Reported Event|Reference (Fed): Algifor Junior|"Algifor® Junior 400 mg/20 ml by mouth under fed condition.~Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.~Algifor® Junior: Algifor® Junior 400 mg/20 ml"
11333863|NCT03520920|OG000|Outcome|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
11333864|NCT03520920|OG001|Outcome|Relapsed/Refractory Follicular Lymphoma|Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
10842425|NCT00246376|FG000|Participant Flow|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
11289097|NCT02918617|OG007|Outcome|Test Cream With Nano-HAP (Higher Concentration)|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Test cream with nano-HAP (higher concentration)"
11289098|NCT02918617|OG008|Outcome|Control Cream Without Nano-HAP|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Control cream without nano-HAP"
11289099|NCT02918617|EG000|Reported Event|Control Toothpaste Containing Novamin® Technology|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing Novamin® technology"
11289100|NCT02918617|EG001|Reported Event|Control Toothpaste Containing 1500 Ppm Fluoride as MFP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste containing 1500 ppm fluoride as MFP"
11289101|NCT02918617|EG002|Reported Event|Test Toothpaste With Nano-HAP (High Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (high concentration)"
11289102|NCT02918617|EG003|Reported Event|Test Toothpaste With Nano-HAP (Low Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (low concentration)"
11289103|NCT02918617|EG004|Reported Event|Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP and KNO3"
11289104|NCT02918617|EG005|Reported Event|Control Toothpaste Without Nano-HAP|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Control toothpaste without nano-HAP"
11289105|NCT02918617|EG006|Reported Event|Test Toothpaste With Nano-HAP (Medium Concentration)|"Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).~Test toothpaste with nano-HAP (medium concentration)"
11289106|NCT02918617|EG007|Reported Event|Test Cream With Nano-HAP (Higher Concentration)|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Test cream with nano-HAP (higher concentration)"
11289107|NCT02918617|EG008|Reported Event|Control Cream Without Nano-HAP|"Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.~Control cream without nano-HAP"
11289108|NCT02918630|BG000|Baseline|Nicotine Replacement Therapy - Nicotine Patch|Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
11289109|NCT02918630|BG001|Baseline|Nicotine Replacement Therapy + E-cigarette|"Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.~E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA)."
11289110|NCT02918630|BG002|Baseline|Total|Total of all reporting groups
11289111|NCT02918630|FG000|Participant Flow|Nicotine Replacement Therapy - Nicotine Patch|Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
11289112|NCT02918630|FG001|Participant Flow|Nicotine Replacement Therapy + E-cigarette|"Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.~E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA)."
11289113|NCT02918630|OG000|Outcome|Nicotine Replacement Therapy - Nicotine Patch|Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
11289114|NCT02918630|OG001|Outcome|Nicotine Replacement Therapy + E-cigarette|"Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.~E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA)."
11289115|NCT02918630|EG000|Reported Event|Nicotine Replacement Therapy - Nicotine Patch|Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
11289116|NCT02918630|EG001|Reported Event|Nicotine Replacement Therapy + E-cigarette|"Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.~E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA)."
11289117|NCT02918656|BG000|Baseline|Infographics|"Infographic presentation of health information~Infographic presentation of health information: The students in this group will read Cochrane systematic review summary in infographics format.~Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs."
11289118|NCT02918656|BG001|Baseline|Plain Language Summary|"PLS presentation of health information~PLS presentation of health information: The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience."
11289119|NCT02918656|BG002|Baseline|Scientific Abstract|"Scientific abstract presentation of health information~Scientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners."
11289120|NCT02918656|BG003|Baseline|Total|Total of all reporting groups
11289121|NCT02918656|FG000|Participant Flow|Infographics|"Infographic presentation of health information~Infographic presentation of health information: The students in this group will read Cochrane systematic review summary in infographics format.~Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs."
11289122|NCT02918656|FG001|Participant Flow|Plain Language Summary|"PLS presentation of health information~PLS presentation of health information: The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience."
11289123|NCT02918656|FG002|Participant Flow|Scientific Abstract|"Scientific abstract presentation of health information~Scientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners."
11289124|NCT02918656|OG000|Outcome|Infographics|"Infographic presentation of health information~Infographic presentation of health information: The students in this group will read Cochrane systematic review summary in infographics format.~Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs."
11289125|NCT02918656|OG001|Outcome|Plain Language Summary|"PLS presentation of health information~PLS presentation of health information: The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience."
11289126|NCT02918656|OG002|Outcome|Scientific Abstract|"Scientific abstract presentation of health information~Scientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners."
11289127|NCT02918656|EG000|Reported Event|Infographics|"Infographic presentation of health information~Infographic presentation of health information: The students in this group will read Cochrane systematic review summary in infographics format.~Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs."
11289128|NCT02918656|EG001|Reported Event|Plain Language Summary|"PLS presentation of health information~PLS presentation of health information: The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience."
11289129|NCT02918656|EG002|Reported Event|Scientific Abstract|"Scientific abstract presentation of health information~Scientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners."
11289130|NCT02918669|BG000|Baseline|Coflex|"Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan.~CT Scan: Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months.~There are no other interventions. It is just a onetime CT post 60 month time point."
11289131|NCT02918669|FG000|Participant Flow|Coflex|"Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan.~CT Scan: Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months.~There are no other interventions. It is just a onetime CT post 60 month time point."
11289132|NCT02918669|OG000|Outcome|Coflex|"Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan.~CT Scan: Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months.~There are no other interventions. It is just a onetime CT post 60 month time point."
11333865|NCT03520920|OG002|Outcome|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
10970798|NCT00912093|EG000|Reported Event|Controlled Phase - Icatibant (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
10970799|NCT00912093|EG001|Reported Event|Controlled Phase -Placebo (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase
10970800|NCT00912093|EG002|Reported Event|Controlled Phase - Icatibant (Open Label)|Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
10970801|NCT00912093|EG003|Reported Event|Open Label Extension - Icatibant (Open Label)|Subjects who treated with icatibant 30 mg in the open label extension phase
10970802|NCT00912197|BG000|Baseline|Oligofructose|Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
10970803|NCT00912197|BG001|Baseline|Cellulose and Maltodextrin|Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
10970804|NCT00912197|BG002|Baseline|Total|Total of all reporting groups
10970805|NCT00912197|FG000|Participant Flow|Oligofructose|Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
10970806|NCT00912197|FG001|Participant Flow|Cellulose and Maltodextrin|Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
10970807|NCT00912197|OG000|Outcome|Oligofructose|Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
10970808|NCT00912197|OG001|Outcome|Cellulose and Maltodextrin|Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
10970809|NCT00912197|OG000|Outcome|Oligofructose|"Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.~Oligofructose: Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in."
10970810|NCT00912197|OG001|Outcome|Cellulose and Maltodextrin|"Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.~Placebo: Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in"
10970811|NCT00912197|EG000|Reported Event|Oligofructose|Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
10970812|NCT00912197|EG001|Reported Event|Cellulose and Maltodextrin|Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
10970813|NCT00912288|BG000|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10970814|NCT00912288|BG001|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10970815|NCT00912288|BG002|Baseline|Total|Total of all reporting groups
10970816|NCT00912288|FG000|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10970817|NCT00912288|FG001|Participant Flow|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10970818|NCT00912288|OG000|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10970819|NCT00912288|OG001|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10970820|NCT00912288|EG000|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
10970821|NCT00912288|EG001|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
10970822|NCT00912301|BG000|Baseline|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
10970823|NCT00912301|BG001|Baseline|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
10970824|NCT00912301|BG002|Baseline|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
10970825|NCT00912301|BG003|Baseline|Total|Total of all reporting groups
10970826|NCT00912301|FG000|Participant Flow|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
10970827|NCT00912301|FG001|Participant Flow|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
10970828|NCT00912301|FG002|Participant Flow|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
10970829|NCT00912301|OG000|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
10970830|NCT00912301|OG001|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
10970831|NCT00912301|OG002|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
10970832|NCT00912301|EG000|Reported Event|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
10970833|NCT00912301|EG001|Reported Event|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
11289133|NCT02918669|EG000|Reported Event|Coflex|Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point.
11289134|NCT02918721|BG000|Baseline|All Study Participants|Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection
11289135|NCT02918721|FG000|Participant Flow|All Study Participants|Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection
11289136|NCT02918721|OG000|Outcome|All Study Participants|"Restylane Lidocaine will be injected into one side nasolabial fold on Day 1~Restylane Lidocaine: Intradermal injection~Restylane will be injected into opp side nasolabial fold on Day 1~Restylane: Intradermal injection"
11289137|NCT02918721|OG000|Outcome|All Study Participants|Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection
11289138|NCT02918721|EG000|Reported Event|All Study Participants|"Restylane Lidocaine will be injected into one side nasolabial fold on Day 1~Restylane Lidocaine: Intradermal injection~Restylane will be injected into one side nasolabial fold on Day 1~Restylane: Intradermal injection"
11289139|NCT02918773|BG000|Baseline|Conventional Otoscope Encounters|Emergency department (ED) encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289140|NCT02918773|BG001|Baseline|Smartphone Otoscope Encounters|Emergency department (ED) encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289141|NCT02918773|BG002|Baseline|Total|Total of all reporting groups
11289142|NCT02918773|FG000|Participant Flow|Conventional Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289143|NCT02918773|FG001|Participant Flow|Smartphone Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289144|NCT02918773|OG000|Outcome|Conventional Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289145|NCT02918773|OG001|Outcome|Smartphone Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289146|NCT02918773|OG000|Outcome|Clinicians Assigned to the Smartphone Otoscope Group|Clinicians assigned to this study arm used a smartphone otoscope rather than a conventional otoscope for all otic examinations during the six month intervention period.
11289147|NCT02918773|EG000|Reported Event|Conventional Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289148|NCT02918773|EG001|Reported Event|Smartphone Otoscope Encounters|Emergency department encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose.
11289149|NCT02918851|BG000|Baseline|7-day Old RBCs|"Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells~Transfusion of 7-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells."
11289150|NCT02918851|BG001|Baseline|28-day Old RBCs|"Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells~Transfusion of 28-day stored red blood cells: Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells."
11289151|NCT02918851|BG002|Baseline|42-day Old RBCs|"Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells~Transfusion of 42-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells."
11289152|NCT02918851|BG003|Baseline|Total|Total of all reporting groups
11289153|NCT02918851|FG000|Participant Flow|7-day Old RBCs|"Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells~Transfusion of 7-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells."
11333866|NCT03520920|EG000|Reported Event|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
11289154|NCT02918851|FG001|Participant Flow|28-day Old RBCs|"Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells~Transfusion of 28-day stored red blood cells: Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells."
11289155|NCT02918851|FG002|Participant Flow|42-day Old RBCs|"Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells~Transfusion of 42-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells."
11289156|NCT02918851|OG000|Outcome|7-day Old RBCs|"Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells~Transfusion of 7-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells."
11289157|NCT02918851|OG001|Outcome|28-day Old RBCs|"Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells~Transfusion of 28-day stored red blood cells: Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells."
11289158|NCT02918851|OG002|Outcome|42-day Old RBCs|"Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells~Transfusion of 42-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells."
11289159|NCT02918851|EG000|Reported Event|7-day Old RBCs|"Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells~Transfusion of 7-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells."
10822169|NCT00074984|OG001|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
10970834|NCT00912301|EG002|Reported Event|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
11289160|NCT02918851|EG001|Reported Event|28-day Old RBCs|"Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells~Transfusion of 28-day stored red blood cells: Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells."
11289161|NCT02918851|EG002|Reported Event|42-day Old RBCs|"Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells~Transfusion of 42-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells."
11289162|NCT02918877|BG000|Baseline|Inhaled Anesthesia|"Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.~Sevoflurane: Volatile Anesthetic"
11289163|NCT02918877|BG001|Baseline|Intravenous Anesthesia|"Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.~Propofol: Intravenous Anesthetic"
11215765|NCT02301403|FG001|Participant Flow|Abstinence-Optimized Cessation Treatment|"There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.~Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking~Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt~Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions~Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions~Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly"
11215766|NCT02301403|OG000|Outcome|Modern Usual Care|"Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).~Nicotine patch: 8 weeks of nicotine patch~in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website"
11215767|NCT02301403|OG001|Outcome|Abstinence-Optimized Cessation Treatment|"There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.~Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking~Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt~Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions~Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions~Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly"
11215768|NCT02301403|EG000|Reported Event|Modern Usual Care|"Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).~Nicotine patch: 8 weeks of nicotine patch~in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website"
11215769|NCT02301403|EG001|Reported Event|Abstinence-Optimized Cessation Treatment|"There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.~Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking~Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt~Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions~Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions~Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly"
11215770|NCT02301416|BG000|Baseline|Phentermine/Topiramate|"All subjects enrolled in the study will be placed on the study medication.~Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery."
11215771|NCT02301416|BG001|Baseline|Surgery Only|Historical controls who had sleeve gastrectomy without phentermine/topiramate
11215772|NCT02301416|BG002|Baseline|Total|Total of all reporting groups
11215773|NCT02301416|FG000|Participant Flow|Phentermine/Topiramate|"All subjects enrolled in the study will be placed on the study medication.~Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery."
11215774|NCT02301416|FG001|Participant Flow|Historical Control|Retrospective chart review of patients who had sleeve gastrectomy without phentermine/topiramate
11215775|NCT02301416|OG000|Outcome|Phentermine/Topiramate|"All subjects enrolled in the study will be placed on the study medication.~Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery."
11215776|NCT02301416|OG001|Outcome|Surgery Only|Historical controls who had surgery only
11215777|NCT02301416|OG001|Outcome|Historical Control|Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
11215778|NCT02301416|EG000|Reported Event|Phentermine/Topiramate|"All subjects enrolled in the study will be placed on the study medication.~Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery."
11215779|NCT02301429|BG000|Baseline|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
11215780|NCT02301429|FG000|Participant Flow|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
11215781|NCT02301429|OG000|Outcome|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
11215782|NCT02301429|EG000|Reported Event|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
11215783|NCT02301546|BG000|Baseline|Experimental Cognitive Training|"Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11289164|NCT02918877|BG002|Baseline|Total|Total of all reporting groups
11289165|NCT02918877|FG000|Participant Flow|Inhaled Anesthesia|"Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.~Sevoflurane: Volatile Anesthetic"
10822170|NCT00074984|EG000|Reported Event|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme(agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
10822171|NCT00074984|EG001|Reported Event|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks
10822172|NCT00074984|EG002|Reported Event|Total|All patients.
11215784|NCT02301546|BG001|Baseline|Control Cognitive Exercises|"Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215785|NCT02301546|BG002|Baseline|Total|Total of all reporting groups
11215786|NCT02301546|FG000|Participant Flow|Experimental Cognitive Training|"Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215787|NCT02301546|FG001|Participant Flow|Control Cognitive Exercises|"Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215788|NCT02301546|OG000|Outcome|Experimental Cognitive Training|"Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215789|NCT02301546|OG001|Outcome|Control Cognitive Exercises|"Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215790|NCT02301546|EG000|Reported Event|Experimental Cognitive Training|"Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215791|NCT02301546|EG001|Reported Event|Control Cognitive Exercises|"Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.~computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings."
11215792|NCT02301624|BG000|Baseline|Eculizumab/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 mg) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11215793|NCT02301624|BG001|Baseline|Placebo/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11215794|NCT02301624|BG002|Baseline|Total|Total of all reporting groups
11215795|NCT02301624|FG000|Participant Flow|Eculizumab/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 milligrams [mg]) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11215796|NCT02301624|FG001|Participant Flow|Placebo/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11215797|NCT02301624|OG000|Outcome|Eculizumab/Eculizumab|After receiving blinded treatment with eculizumab in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
11215798|NCT02301624|OG001|Outcome|Placebo/Eculizumab|After receiving blinded treatment with placebo in Study ECU-MG-301 for 26 weeks, all participants received blinded study drug weekly for 4 weeks, then received open-label eculizumab 1200 mg every 2 weeks for up to 4 years in this extension study.
11215799|NCT02301624|EG000|Reported Event|Eculizumab/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 mg) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11333867|NCT03520920|EG001|Reported Event|Relapsed/Refractory Follicular Lymphoma|Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
10970835|NCT00912340|BG000|Baseline|Trastuzumab|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
10970836|NCT00912340|BG001|Baseline|Everolimus|Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
10970837|NCT00912340|BG002|Baseline|Trastuzumab and Everolimus (ARM REMOVED)|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
10970838|NCT00912340|BG003|Baseline|Total|Total of all reporting groups
10970839|NCT00912340|FG000|Participant Flow|Trastuzumab|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
10970840|NCT00912340|FG001|Participant Flow|Everolimus|Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
11215800|NCT02301624|EG001|Reported Event|Placebo/Eculizumab|"Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3.~Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
10822173|NCT00075023|BG000|Baseline|Thalidomide Gel|Thalidomide Gel
10822174|NCT00075023|BG001|Baseline|Placebo|Placebo Gel
10970841|NCT00912340|FG002|Participant Flow|Trastuzumab and Everolimus (ARM REMOVED)|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
10970842|NCT00912340|OG000|Outcome|Trastuzumab|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
10970843|NCT00912340|OG001|Outcome|Everolimus|Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
10970844|NCT00912340|OG002|Outcome|Trastuzumab and Everolimus (ARM REMOVED)|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
10970845|NCT00912340|EG000|Reported Event|Trastuzumab|Patients receive 10 mg everolimus PO daily and continue to receive their most recent hormone therapy. Patients achieving disease progression receive 8 mg/kg trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
10970846|NCT00912340|EG001|Reported Event|Everolimus|Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
10970847|NCT00912340|EG002|Reported Event|Trastuzumab and Everolimus (ARM REMOVED)|Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
10970848|NCT00912405|BG000|Baseline|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
10970849|NCT00912405|FG000|Participant Flow|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
10970850|NCT00912405|OG000|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
11215801|NCT02301624|EG002|Reported Event|Eculizumab (Combined Total)|"All participants who received at least 1 dose of eculizumab in the extension study. Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study.~Eculizumab 1200 mg was administered for up to 4 years in this extension study."
11215802|NCT02301793|BG000|Baseline|Contemporary Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.~Intervention: Nurse education in contemporary format~Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format"
11215803|NCT02301793|BG001|Baseline|Traditional Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.~Intervention: Nurse education in traditional format~Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over."
11215804|NCT02301793|BG002|Baseline|Total|Total of all reporting groups
11215805|NCT02301793|FG000|Participant Flow|Contemporary Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.~Intervention: Nurse education in contemporary format~Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format"
11215806|NCT02301793|FG001|Participant Flow|Traditional Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.~Intervention: Nurse education in traditional format~Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over."
11215807|NCT02301793|OG000|Outcome|Contemporary Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.~Intervention: Nurse education in contemporary format~Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format"
11333868|NCT03520920|EG002|Reported Event|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
11289166|NCT02918877|FG001|Participant Flow|Intravenous Anesthesia|"Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.~Propofol: Intravenous Anesthetic"
11289167|NCT02918877|OG000|Outcome|Inhaled Anesthesia|"Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.~Sevoflurane: Volatile Anesthetic"
11289168|NCT02918877|OG001|Outcome|Intravenous Anesthesia|"Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.~Propofol: Intravenous Anesthetic"
11289169|NCT02918877|EG000|Reported Event|Inhaled Anesthesia|"Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.~Sevoflurane: Volatile Anesthetic"
11289170|NCT02918877|EG001|Reported Event|Intravenous Anesthesia|"Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.~Propofol: Intravenous Anesthetic"
11289171|NCT02918968|BG000|Baseline|Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT|Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289172|NCT02918968|BG001|Baseline|Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT|Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289173|NCT02918968|BG002|Baseline|Total|Total of all reporting groups
11289174|NCT02918968|FG000|Participant Flow|Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT|Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289175|NCT02918968|FG001|Participant Flow|Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT|Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289176|NCT02918968|OG000|Outcome|Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT|Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289177|NCT02918968|OG001|Outcome|Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT|Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event, participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
11289178|NCT02918968|EG000|Reported Event|Enzalutamide 160mg 1st Line AAT|Participants received enzalutamide 160mg capsules orally once daily as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event (approximately 38 months).
11289179|NCT02918968|EG001|Reported Event|Enzalutamide 160mg 2nd Line AAT|Participants received enzalutamide 160mg capsules orally once daily as 2nd line of AAT after confirmed PSA progression, other disease progression, or an intolerable adverse event (approximately 38 months).
11289180|NCT02918968|EG002|Reported Event|Flutamide 375mg 1st Line AAT|Participants received flutamide 125mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event (approximately 38 months).
11289181|NCT02918968|EG003|Reported Event|Flutamide 375mg 2nd Line AAT|Participants received flutamide 125mg tablets orally thrice daily as 2nd line of AAT after confirmed PSA progression, other disease progression, or an intolerable adverse event (approximately 38 months).
11333869|NCT03520959|BG000|Baseline|Placebo|CMB305 placebo control
10822175|NCT00075023|BG002|Baseline|Total|Total of all reporting groups
10822176|NCT00075023|FG000|Participant Flow|Thalidomide Gel|Thalidomide Gel
10822177|NCT00075023|FG001|Participant Flow|Placebo|Placebo Gel
10822178|NCT00075023|OG000|Outcome|Thalidomide Gel|Thalidomide Gel
10822179|NCT00075023|OG001|Outcome|Placebo|Placebo Gel
10822180|NCT00075023|EG000|Reported Event|Thalidomide Gel|Thalidomide Gel
10822181|NCT00075023|EG001|Reported Event|Placebo|Placebo Gel
11289182|NCT02919007|BG000|Baseline|Silk'h HST Treatment|"Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.~Silk'h HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual"
11289183|NCT02919007|FG000|Participant Flow|Silk'h HST Treatment|"Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.~Silk'h HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual"
11289184|NCT02919007|OG000|Outcome|Silk'n HST Treatment|"Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.~Silk'n HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual"
11289185|NCT02919007|EG000|Reported Event|Silk'h HST Treatment|"Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.~Silk'h HST treatment: Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual"
11289186|NCT02919111|BG000|Baseline|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289187|NCT02919111|FG000|Participant Flow|Ga-68 Labeled PSMA-11 PET|"PSMA Positron Emission Tomography (PET) imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289188|NCT02919111|OG000|Outcome|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289189|NCT02919111|EG000|Reported Event|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11289190|NCT02919267|BG000|Baseline|Intra-pulmonary Pressure Measurements With Double-lumen Tube|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289191|NCT02919267|BG001|Baseline|Intra-pulmonary Pressure Determination With Bronchial Blocker|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289192|NCT02919267|BG002|Baseline|Gas Movement Quantification With Double-lumen Tube|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289193|NCT02919267|BG003|Baseline|Gas Movement Quantification With Bronchial Blocker|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289194|NCT02919267|BG004|Baseline|Total|Total of all reporting groups
11289195|NCT02919267|FG000|Participant Flow|Intra-pulmonary Pressure Measurements With Double-lumen Tube|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289196|NCT02919267|FG001|Participant Flow|Intra-pulmonary Pressure Determination With Bronchial Blocker|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289197|NCT02919267|FG002|Participant Flow|Gas Movement Quantification With Double-lumen Tube|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289198|NCT02919267|FG003|Participant Flow|Gas Movement Quantification With Bronchial Blocker|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289199|NCT02919267|OG000|Outcome|Gas Movement Quantification With Double-lumen Tube|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289200|NCT02919267|OG001|Outcome|Gas Movement Quantification With Bronchial Blocker|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289201|NCT02919267|OG000|Outcome|Intra-pulmonary Pressure Measurements With Double-lumen Tube|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11333870|NCT03520959|BG001|Baseline|CMB305|CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
11333871|NCT03520959|BG002|Baseline|Total|Total of all reporting groups
11333872|NCT03520959|FG000|Participant Flow|Placebo|CMB305 placebo control
10970851|NCT00912405|EG000|Reported Event|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
11289202|NCT02919267|OG001|Outcome|Intra-pulmonary Pressure Determination With Bronchial Blocker|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289203|NCT02919267|EG000|Reported Event|Intra-pulmonary Pressure Measurements With Double-lumen Tube|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289204|NCT02919267|EG001|Reported Event|Intra-pulmonary Pressure Determination With Bronchial Blocker|For patients randomized to the intra-pulmonary pressure measurements, a pressure-tubing catheter was connected to the luerlock adaptor of the BB or to the adaptor located on the side of the occluding system mounted at the extremity of the DLT. The catheter was connected to a differential pressure transducer. Signals were amplified with a CD15 Carrier Demodulator then digitized at 5 Hz and sampled using an MP100 analogic/numeric system. Continuous pressure measurements were recorded before and after pleural opening by the surgeon. Tracings were recorded and subsequent off-line analyses were accomplished using ACQKnowledge and pressures were averaged every 30 seconds, excluding aberrant measures (above and below 2 SD of the mean).
11289205|NCT02919267|EG002|Reported Event|Gas Movement Quantification With Double-lumen Tube|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289206|NCT02919267|EG003|Reported Event|Gas Movement Quantification With Bronchial Blocker|For patients randomized to the gas movement quantification, a 2-liter bag was filled with 1000 mL of air with a 1000 mL calibrated syringe and a pneumotachometer through a 3-way valve prior to OLV. The pneumotachometer signal was amplified with Pneumotach Amplifier 1 and digitized at 200 Hz using MP100 analogic/numeric system. Volume were measured with ACQKnowledge by integration of flows measured with the pneumotachometer. One minute after initiation of OLV, the three-way valve was connected to the non-ventilated lumen of the DLT or to the internal chanel of the BB through an adaptor. Immediately prior to opening of the pleura, the volume measurement bag was closed and apnea was re-established in both groups for one minute as described above, after which measurements resumed for a total duration of 60 minutes of OLV. At the end of the observation period, the bag was emptied with the one-liter syringe through the pneumotachometer to measure its residual volume.
11289207|NCT02919423|BG000|Baseline|10 Hz TMS|This group received 10 Hz TMS
11289208|NCT02919423|BG001|Baseline|1 Hz TMS|This group received 1 Hz TMS
11289209|NCT02919423|BG002|Baseline|Total|Total of all reporting groups
11289210|NCT02919423|FG000|Participant Flow|10 Hz TMS|This group received 10 Hz TMS
11289211|NCT02919423|FG001|Participant Flow|1 Hz TMS|This group received 1 Hz TMS
11289212|NCT02919423|OG000|Outcome|10 Hz TMS|This group received 10 Hz TMS
11289213|NCT02919423|OG001|Outcome|1 Hz TMS|This group received 1 Hz TMS
11289214|NCT02919423|EG000|Reported Event|10 Hz TMS|This group received 10 Hz TMS
11289215|NCT02919423|EG001|Reported Event|1 Hz TMS|This group received 1 Hz TMS
11289216|NCT02919475|BG000|Baseline|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11289217|NCT02919475|BG001|Baseline|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11289218|NCT02919475|BG002|Baseline|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11289219|NCT02919475|BG003|Baseline|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11289220|NCT02919475|BG004|Baseline|Placebo|Placebo orally once daily for 12 weeks
11289221|NCT02919475|BG005|Baseline|Total|Total of all reporting groups
11289222|NCT02919475|FG000|Participant Flow|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11289223|NCT02919475|FG001|Participant Flow|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11289224|NCT02919475|FG002|Participant Flow|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11289225|NCT02919475|FG003|Participant Flow|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
10842426|NCT00246376|FG001|Participant Flow|Group 2: Diet / Exercise|Diet, exercise, and two placebos
10842427|NCT00246376|FG002|Participant Flow|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
10842428|NCT00246376|FG003|Participant Flow|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
11289226|NCT02919475|FG004|Participant Flow|Placebo|Placebo orally once daily for 12 weeks
11289227|NCT02919475|OG000|Outcome|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11289228|NCT02919475|OG001|Outcome|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11289229|NCT02919475|OG002|Outcome|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11289230|NCT02919475|OG003|Outcome|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11289231|NCT02919475|OG004|Outcome|Placebo|Placebo orally once daily for 12 weeks
11289232|NCT02919475|EG000|Reported Event|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11289233|NCT02919475|EG001|Reported Event|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11289234|NCT02919475|EG002|Reported Event|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11289235|NCT02919475|EG003|Reported Event|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11289236|NCT02919475|EG004|Reported Event|Placebo|Placebo orally once daily for 12 weeks
11289237|NCT02919657|BG000|Baseline|All Participants|All participants were given a baseline blood analysis
11289238|NCT02919657|FG000|Participant Flow|Genepro Gen2 Protein Then Whey Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~30g Serving of Whey Isolate Protein will be used daily in each subject."
11289239|NCT02919657|FG001|Participant Flow|Whey Protein Isolate Then Genepro Gen2 Protein|"30g Serving of Whey Isolate Protein will be used daily in each subject.~1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject."
11289240|NCT02919657|OG000|Outcome|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
11289241|NCT02919657|OG001|Outcome|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
11289242|NCT02919657|EG000|Reported Event|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
11289243|NCT02919657|EG001|Reported Event|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
11289244|NCT02919696|BG000|Baseline|Abemaciclib 150 mg|Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289245|NCT02919696|BG001|Baseline|Abemaciclib 200 mg|Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289246|NCT02919696|BG002|Baseline|Total|Total of all reporting groups
11289247|NCT02919696|FG000|Participant Flow|Abemaciclib 150 mg|"Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.~One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses."
11289248|NCT02919696|FG001|Participant Flow|Abemaciclib 200 mg|"Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.~One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses."
11289249|NCT02919696|OG000|Outcome|Abemaciclib 150 mg|Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289250|NCT02919696|OG001|Outcome|Abemaciclib 200 mg|Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289251|NCT02919696|OG000|Outcome|Abemaciclib 100 mg|Abemaciclib 100 mg administered every 12 hours, orally, during cycle 1. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289252|NCT02919696|OG001|Outcome|Abemaciclib 150 mg|Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289253|NCT02919696|OG002|Outcome|Abemaciclib 200 mg|Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289254|NCT02919696|OG000|Outcome|Abemaciclib 150 mg|Abemaciclib 150 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289255|NCT02919696|OG001|Outcome|Abemaciclib 150 mg|Abemaciclib 150 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289256|NCT02919696|OG001|Outcome|Abemaciclib 200 mg|"Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.~One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses."
10842429|NCT00246376|FG004|Participant Flow|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
10842430|NCT00246376|OG000|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
11289257|NCT02919696|EG000|Reported Event|Abemaciclib 150 mg|Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289258|NCT02919696|EG001|Reported Event|Abemaciclib 200 mg|Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
11289259|NCT02919761|BG000|Baseline|Part 1: All Participants Enrolled|All participants who enrolled in the trial
11289260|NCT02919761|FG000|Participant Flow|All Enrolled Participants|All participants who enrolled in the trial
11289261|NCT02919761|FG001|Participant Flow|Part 2: Acthar Gel|Participants receive 1 mL Acthar Gel twice weekly during Part 2, from Week 12 through Week 24
11289262|NCT02919761|FG002|Participant Flow|Part 2: Placebo|Participants receive 1 mL placebo twice weekly during Part 2, from Week 12 through Week 24
11289263|NCT02919761|OG000|Outcome|Part 1: All Participants Enrolled|All participants who enrolled in the trial
11289264|NCT02919761|OG000|Outcome|Part 2: Placebo|Participants receive Placebo 1 mL twice weekly during Part 2, from Week 12 through week 24
11289265|NCT02919761|OG001|Outcome|Part 2: Acthar Gel|Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
11289266|NCT02919761|OG000|Outcome|Part 2: Placebo|Participants receive Placebo during Part 2
11289267|NCT02919761|OG001|Outcome|Part 2: Acthar Gel|Participants who receive Acthar Gel during Part 2
11289268|NCT02919761|OG000|Outcome|Part 2: Placebo|Participants who receive Placebo during Part 2
11289269|NCT02919761|EG000|Reported Event|Part 1: All Participants Enrolled|All participants enrolled in the trial with AEs during Part 1
11289270|NCT02919761|EG001|Reported Event|Part 2: Placebo|Participants who received Placebo in Part 2 with AEs during Part 2
11289271|NCT02919761|EG002|Reported Event|Part 2: Acthar Gel|Participants who received Acthar Gel in Part 2 with AEs during Part 2
11289272|NCT02919813|BG000|Baseline|M-gCBT Group|"Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) is a type of counseling that teaches women to have more control over their pain.~Mindfulness Based Group Cognitive BehaviorTherapy: Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain."
11289273|NCT02919813|BG001|Baseline|Educational Seminars|"Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.~Educational Seminars: Educational seminars teach women about the different aspects of PLV that affect emotional and physical health."
11289274|NCT02919813|BG002|Baseline|Total|Total of all reporting groups
11289275|NCT02919813|FG000|Participant Flow|M-gCBT Group|"Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) is a type of counseling that teaches women to have more control over their pain.~Mindfulness Based Group Cognitive BehaviorTherapy: Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain."
11289276|NCT02919813|FG001|Participant Flow|Educational Seminars|"Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.~Educational Seminars: Educational seminars teach women about the different aspects of PLV that affect emotional and physical health."
11289277|NCT02919813|OG000|Outcome|M-gCBT Group|"Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) is a type of counseling that teaches women to have more control over their pain.~Mindfulness Based Group Cognitive BehaviorTherapy: Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain."
11289278|NCT02919813|OG001|Outcome|Educational Seminars|"Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.~Educational Seminars: Educational seminars teach women about the different aspects of PLV that affect emotional and physical health."
11289279|NCT02919813|EG000|Reported Event|M-gCBT Group|"Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) is a type of counseling that teaches women to have more control over their pain.~Mindfulness Based Group Cognitive BehaviorTherapy: Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain."
11289280|NCT02919813|EG001|Reported Event|Educational Seminars|"Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.~Educational Seminars: Educational seminars teach women about the different aspects of PLV that affect emotional and physical health."
11289281|NCT02919826|BG000|Baseline|DBT Group|"Adapted Dialectical Behaviour Therapy~Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy"
11289282|NCT02919826|BG001|Baseline|Control Arm|People in this group will receive treatment as usual
11289283|NCT02919826|BG002|Baseline|Total|Total of all reporting groups
11289284|NCT02919826|FG000|Participant Flow|DBT Group|"Adapted Dialectical Behaviour Therapy~Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy"
11289285|NCT02919826|FG001|Participant Flow|Control Arm|People in this group will receive treatment as usual
11289286|NCT02919826|OG000|Outcome|DBT Group Intervention|"Adapted Dialectical Behaviour Therapy~Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy"
11289287|NCT02919826|OG001|Outcome|Control Arm|People in this group will receive treatment as usual
11289288|NCT02919826|OG000|Outcome|DBT Group Intervention|DBT Group Intervention
11289289|NCT02919826|OG001|Outcome|DBT Control Group|DBT Control Group will receive treatment as usual.
11289290|NCT02919826|EG000|Reported Event|DBT Group|"Adapted Dialectical Behaviour Therapy~Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy"
11289291|NCT02919826|EG001|Reported Event|Control Arm|People in this group will receive treatment as usual
11289292|NCT02919995|BG000|Baseline|Higher Dose RPL554/Lower Dose RPL554/Placebo|"Single dose of inhaled 6 mg RPL554 in Period 1, single dose of inhaled 1.5 mg RPL554 in Period 2, single inhaled dose of placebo in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289293|NCT02919995|BG001|Baseline|Lower Dose RPL554/Placebo/Higher Dose RPL554|"Single dose of inhaled 1.5 mg RPL554 in Period 1, single dose of inhaled placebo RPL554 in Period 2, single dose of 6 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289294|NCT02919995|BG002|Baseline|Higher Dose RPL554/Placebo/Lower Dose RPL554|"Single dose of inhaled 6 mg RPL554 in Period 1, single dose of inhaled placebo in Period 2, single dose of inhaled 1.5 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289295|NCT02919995|BG003|Baseline|Lower Dose RPL554/Higher Dose RPL554/Placebo|"Single dose of inhaled 1.5 mg RPL554 in Period 1, single dose of inhaled 6 mg RPL554 in Period 2, single inhaled dose of placebo in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289296|NCT02919995|BG004|Baseline|Placebo/Higher Dose RPL554/Lower Dose RPL554|"Single dose of inhaled placebo in Period 1, single dose of inhaled 6 mg RPL554 in Period 2, single dose of inhaled 1.5 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289297|NCT02919995|BG005|Baseline|Placebo/Lower Dose RPL554/Higher Dose RPL554|"Single dose of inhaled placebo in Period 1, single dose of inhaled 1.5 mg RPL554 in Period 2, single dose of inhaled 6 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289298|NCT02919995|BG006|Baseline|Total|Total of all reporting groups
11289299|NCT02919995|FG000|Participant Flow|Higher Dose RPL554/Lower Dose RPL554/Placebo|"Single dose of inhaled 6 mg RPL554 in Period 1, Single inhaled dose of 1.5 mg RPL554 in Period 2, placebo in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289300|NCT02919995|FG001|Participant Flow|Lower Dose RPL554/Placebo/Higher Dose RPL554|"Single dose of inhaled 1.5 mg RPL554 in Period 1, single inhaled dose of placebo in Period 2, single inhaled dose of 6 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289301|NCT02919995|FG002|Participant Flow|Higher Dose RPL554/Plaebo/Lower Dose RPL554|"Single inhaled dose of 6 mg RPL554 in Period 1, single inhaled dose of placebo in Period 2, single inhaled dose of 1.5 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289302|NCT02919995|FG003|Participant Flow|Lower Dose RPL554/Higher Dose RPL554/Placebo|"Single inhaled dose of 1.5 mg RPL554 in Period 1, single inhaled dose of 6 mg RPL554 in Period 2, single inhaled dose of placebo in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289303|NCT02919995|FG004|Participant Flow|Placebo/Higher Dose RPL554/Lower Dose RPL554|"Single inhaled dose of placebo in Period 1, single inhaled dose of 6 mg RPL554 in Period 2, single inhaled dose of 1.5 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289304|NCT02919995|FG005|Participant Flow|Placebo/Lower Dose RPL554/Higher Dose RPL554|"Single inhaled dose of placebo in Period 1, single inhaled dose of 1.5 mg RPL554 in Period 2, single inhaled dose of 6 mg RPL554 in Period 3~RPL554: RPL554 suspension administered using a nebuliser Placebo: Placebo solution administered using a nebuliser"
11289305|NCT02919995|OG000|Outcome|Higher Dose RPL554|"Single dose of inhaled 6 mg RPL554~RPL554: RPL554 suspension administered using a nebuliser"
11289306|NCT02919995|OG001|Outcome|Lower Dose RPL554|"Single dose of inhaled 1.5 mg RPL554~RPL554: RPL554 suspension administered using a nebuliser"
11289307|NCT02919995|OG002|Outcome|Placebo|"Inhaled placebo dose~Placebo: Placebo solution administered using a nebuliser"
11289308|NCT02919995|EG000|Reported Event|Higher Dose RPL554|"Single dose of inhaled 6 mg RPL554~RPL554: RPL554 suspension administered using a nebuliser"
11289309|NCT02919995|EG001|Reported Event|Lower Dose RPL554|"Single dose of inhaled 1.5 mg RPL554~RPL554: RPL554 suspension administered using a nebuliser"
11289310|NCT02919995|EG002|Reported Event|Placebo|"Inhaled placebo dose~Placebo: Placebo solution administered using a nebuliser"
11289311|NCT02920528|BG000|Baseline|Placebo|"placebo controlled arm~Placebo: Normal Saline"
11289312|NCT02920528|BG001|Baseline|Very Low Dose Ketamine|"0.25 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289313|NCT02920528|BG002|Baseline|Low Dose Ketamine|"0.50 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289314|NCT02920528|BG003|Baseline|Total|Total of all reporting groups
11289315|NCT02920528|FG000|Participant Flow|Placebo|"placebo controlled arm~Placebo: Normal Saline"
11289316|NCT02920528|FG001|Participant Flow|Very Low Dose Ketamine|"0.25 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289317|NCT02920528|FG002|Participant Flow|Low Dose Ketamine|"0.50 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289318|NCT02920528|OG000|Outcome|Placebo|"placebo controlled arm~Placebo: Normal Saline"
11289319|NCT02920528|OG001|Outcome|Very Low Dose Ketamine|"0.25 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289320|NCT02920528|OG002|Outcome|Low Dose Ketamine|"0.50 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289321|NCT02920528|EG000|Reported Event|Placebo|"placebo controlled arm~Placebo: Normal Saline"
11289322|NCT02920528|EG001|Reported Event|Very Low Dose Ketamine|"0.25 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289323|NCT02920528|EG002|Reported Event|Low Dose Ketamine|"0.50 mg/kg of sub-dissociative ketamine as an experimental arm~Ketamine: sub-dissociative ketamine"
11289324|NCT02920749|BG000|Baseline|Group A|General anaesthesia was maintained with sevoflurane.
11289325|NCT02920749|BG001|Baseline|Group B|Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
11289326|NCT02920749|BG002|Baseline|Group C|General anaesthesia was maintained with propofol.
11289327|NCT02920749|BG003|Baseline|Group D|Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
11215808|NCT02301793|OG001|Outcome|Traditional Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.~Intervention: Nurse education in traditional format~Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over."
11215809|NCT02301793|EG000|Reported Event|Contemporary Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.~Intervention: Nurse education in contemporary format~Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format"
11215810|NCT02301793|EG001|Reported Event|Traditional Education Format|"Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.~Intervention: Nurse education in traditional format~Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over."
11215811|NCT02301897|BG000|Baseline|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
11215812|NCT02301897|BG001|Baseline|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215813|NCT02301897|BG002|Baseline|Placebo|Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215814|NCT02301897|BG003|Baseline|Total|Total of all reporting groups
11215815|NCT02301897|FG000|Participant Flow|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
11215816|NCT02301897|FG001|Participant Flow|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215817|NCT02301897|FG002|Participant Flow|Placebo|Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215818|NCT02301897|OG000|Outcome|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
11215819|NCT02301897|OG001|Outcome|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215820|NCT02301897|OG002|Outcome|Placebo|Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215821|NCT02301897|EG000|Reported Event|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
11215822|NCT02301897|EG001|Reported Event|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215823|NCT02301897|EG002|Reported Event|Placebo|Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
11215824|NCT02301936|BG000|Baseline|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
11215825|NCT02301936|BG001|Baseline|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
11215826|NCT02301936|BG002|Baseline|Total|Total of all reporting groups
11215827|NCT02301936|FG000|Participant Flow|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
11215828|NCT02301936|FG001|Participant Flow|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
11215829|NCT02301936|OG000|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
11215830|NCT02301936|OG001|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
11215831|NCT02301936|EG000|Reported Event|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
11215832|NCT02301936|EG001|Reported Event|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
11215833|NCT02301975|BG000|Baseline|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215834|NCT02301975|BG001|Baseline|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215835|NCT02301975|BG002|Baseline|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11289328|NCT02920749|BG004|Baseline|Total|Total of all reporting groups
11289329|NCT02920749|FG000|Participant Flow|Group A|Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
11289330|NCT02920749|FG001|Participant Flow|Group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
11289331|NCT02920749|FG002|Participant Flow|Group C|Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
11289332|NCT02920749|FG003|Participant Flow|Group D|In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
11289333|NCT02920749|OG000|Outcome|Group A|Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
11289334|NCT02920749|OG001|Outcome|Group B|"Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.~."
11289335|NCT02920749|OG002|Outcome|Group C|Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
11289336|NCT02920749|OG003|Outcome|Group D|Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
11289337|NCT02920749|OG000|Outcome|Group A|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
11289338|NCT02920749|OG001|Outcome|Group B|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
11289339|NCT02920749|OG002|Outcome|Group C|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
11289340|NCT02920749|OG003|Outcome|Group D|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
11289341|NCT02920749|EG000|Reported Event|Group A|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
11289342|NCT02920749|EG001|Reported Event|Group B|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram.~."
11289343|NCT02920749|EG002|Reported Event|Group C|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
11289344|NCT02920749|EG003|Reported Event|Group D|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
11289345|NCT02920918|BG000|Baseline|Canagliflozin|"Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Canagliflozin"
11289346|NCT02920918|BG001|Baseline|Sitagliptin|"Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Sitagliptin"
11289347|NCT02920918|BG002|Baseline|Total|Total of all reporting groups
11289348|NCT02920918|FG000|Participant Flow|Canagliflozin|"Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Canagliflozin"
11289349|NCT02920918|FG001|Participant Flow|Sitagliptin|"Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Sitagliptin"
11289350|NCT02920918|OG000|Outcome|Canagliflozin|"Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Canagliflozin"
11289351|NCT02920918|OG001|Outcome|Sitagliptin|"Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Sitagliptin"
11289352|NCT02920918|EG000|Reported Event|Canagliflozin|"Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Canagliflozin"
11289353|NCT02920918|EG001|Reported Event|Sitagliptin|"Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.~Sitagliptin"
11289354|NCT02920957|BG000|Baseline|Overall Baseline Characteristics|Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first.
11289355|NCT02920957|FG000|Participant Flow|Comfilcon A First Then Senofilcon C|Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C
11289356|NCT02920957|FG001|Participant Flow|Senofilcon C First Then Comfilcon A|Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A
11289357|NCT02920957|OG000|Outcome|Comfilcon A at Dispense|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
11289358|NCT02920957|OG001|Outcome|Comfilcon A After 2 Weeks|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
11289359|NCT02920957|OG002|Outcome|Comfilcon A After 1 Month|"Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.~comfilcon A: contact lens"
11289360|NCT02920957|OG003|Outcome|Senofilcon C at Dispense|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
10822182|NCT00075023|EG002|Reported Event|Adverse Events for All Participants|These are adverse events for participants as reported to the DSMB, without information related to treatment arm
10822183|NCT00075088|BG000|Baseline|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
10970852|NCT00912509|BG000|Baseline|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
11215836|NCT02301975|BG003|Baseline|Total|Total of all reporting groups
11215837|NCT02301975|FG000|Participant Flow|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215838|NCT02301975|FG001|Participant Flow|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215839|NCT02301975|FG002|Participant Flow|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215840|NCT02301975|OG000|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215841|NCT02301975|OG001|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215842|NCT02301975|OG002|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215843|NCT02301975|EG000|Reported Event|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215844|NCT02301975|EG001|Reported Event|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215845|NCT02301975|EG002|Reported Event|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
11215846|NCT02301988|BG000|Baseline|Ipatasertib + Paclitaxel|Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).
11215847|NCT02301988|BG001|Baseline|Placebo + Paclitaxel|Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
11215848|NCT02301988|BG002|Baseline|Total|Total of all reporting groups
11215849|NCT02301988|FG000|Participant Flow|Ipatasertib + Paclitaxel|Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).
11215850|NCT02301988|FG001|Participant Flow|Placebo + Paclitaxel|Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
11215851|NCT02301988|OG000|Outcome|Ipatasertib + Paclitaxel|Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).
11215852|NCT02301988|OG001|Outcome|Placebo + Paclitaxel|Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
11215853|NCT02301988|EG000|Reported Event|Ipatasertib + Paclitaxel|Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).
11215854|NCT02301988|EG001|Reported Event|Placebo + Paclitaxel|Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
11215855|NCT02302066|BG000|Baseline|Group 1 (TDV 2-Dose)|Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215856|NCT02302066|BG001|Baseline|Group 2 (TDV 1-Dose)|Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215857|NCT02302066|BG002|Baseline|Group 3 (TDV 1-Dose + Booster)|Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215858|NCT02302066|BG003|Baseline|Group 4 (Placebo Control)|Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215859|NCT02302066|BG004|Baseline|Total|Total of all reporting groups
11215860|NCT02302066|FG000|Participant Flow|Group 1 (TDV 2-Dose)|Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215861|NCT02302066|FG001|Participant Flow|Group 2 (TDV 1-Dose)|Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215862|NCT02302066|FG002|Participant Flow|Group 3 (TDV 1-Dose + Booster)|Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215863|NCT02302066|FG003|Participant Flow|Group 4 (Placebo Control)|Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11289361|NCT02920957|OG004|Outcome|Senofilcon C After 2 Weeks|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
11289362|NCT02920957|OG005|Outcome|Senofilcon C After 1 Month|"Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.~senofilcon C: contact lens"
11289363|NCT02920957|OG000|Outcome|Comfilcon A at Dispense|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
11289364|NCT02920957|OG001|Outcome|Comfilcon A After 2 Weeks|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
11289365|NCT02920957|OG002|Outcome|Comfilcon A After 1 Month|Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
11289366|NCT02920957|OG003|Outcome|Senofilcon C at Dispense|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
11289367|NCT02920957|OG004|Outcome|Senofilcon C After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
11289368|NCT02920957|OG005|Outcome|Senofilcon C After 1 Month|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
11289369|NCT02920957|OG004|Outcome|Senofilcon c After 2 Weeks|Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.
11289370|NCT02920957|EG000|Reported Event|Comfilcon A|Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention.
11289371|NCT02920957|EG001|Reported Event|Senofilcon C|Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention.
11289372|NCT02920970|BG000|Baseline|Overall Number of Baseline Participants|Total number of participants enrolled in the study.
11289373|NCT02920970|FG000|Participant Flow|Stenfilcon A First Then Narafilcon A|Participants are randomized to wear stenfilcon A lens first for one week then narafilcon A.
11289374|NCT02920970|FG001|Participant Flow|Narafilcon A First Then Stenfilcon A|Participants are randomized to wear narafilcon A lens first for one week then stenfilcon A.
11289375|NCT02920970|OG000|Outcome|Stenfilcon A|Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
11289376|NCT02920970|OG001|Outcome|Narafilcon A|Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
11289377|NCT02920970|OG000|Outcome|Stenfilcon A|Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.
11289378|NCT02920970|OG001|Outcome|Narafilcon A|Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
11289379|NCT02920970|EG000|Reported Event|Stenfilcon A|Participants are randomized to wear stenfilcon A as the first or second lens pair for one week during the cross over study.
11289380|NCT02920970|EG001|Reported Event|Narafilcon A|Participants are randomized to wear narafilcon A as the first or second lens pair for one week during the cross over study.
11289381|NCT02920983|BG000|Baseline|Overall Study|Total participants
11289382|NCT02920983|FG000|Participant Flow|Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2|Subjects are randomized to wear somofilcon A pair of lenses for one week during the crossover study then nelfilcon A II2, then omafilcon A II 2 lenses for one week each.
11289383|NCT02920983|FG001|Participant Flow|Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2|Subjects are randomized to wear somofilcon A pair of lenses for one week during the cross-over study then omafilcon A II 2, then nelfilcon A II 2 lenses for one week each.
11289384|NCT02920983|FG002|Participant Flow|Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2|Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then Omafilcon A II 2 lenses for one week each.
11289385|NCT02920983|FG003|Participant Flow|Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A|Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Omafilcon A II 2, then Somofilcon A, lenses for one week each.
11289386|NCT02920983|FG004|Participant Flow|Omafilcon A II 2, Nelficon A II 2, Somofilcon A|Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then nelfilcon A II 2, then Somofilcon A lenses for one week each.
11289387|NCT02920983|FG005|Participant Flow|Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2|Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then nelfilcon A II 2 lenses for one week each.
11289388|NCT02920983|OG000|Outcome|Somofilcon A|"Subjects are randomized to wear somofilcon A for one week during the cross over study.~somofilcon A: contact lens"
11289389|NCT02920983|OG001|Outcome|Nelfilcon A II 2|"Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.~nelfilcon A II 2: contact lens"
11289390|NCT02920983|OG002|Outcome|Omafilcon A ll 2|"Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.~omafilcon A ll 2: contact lens"
11289391|NCT02920983|EG000|Reported Event|Somofilcon A|Subjects are randomized to wear Somofilcon A for one week at random sequence
11289392|NCT02920983|EG001|Reported Event|Nelfilcon A II 2|Subjects are randomized to wear Nelfilcon A II 2 for one week at random sequence
11289393|NCT02920983|EG002|Reported Event|Omafilcon A II 2|Subjects are randomized to wear Omafilcon A II 2 for one week at random sequence
11289394|NCT02921061|BG000|Baseline|Treatment (Decitabine 20 mg/m2 and G-CLAM)|"Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3).~Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM.~Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks)."
11333873|NCT03520959|FG001|Participant Flow|CMB305|CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
11333874|NCT03520959|OG000|Outcome|Placebo|CMB305 placebo control
11215864|NCT02302066|OG000|Outcome|Group 1 (TDV 2-Dose)|Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215865|NCT02302066|OG001|Outcome|Group 2 (TDV 1-Dose)|Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215866|NCT02302066|OG002|Outcome|Group 3 (TDV 1-Dose + Booster)|Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215867|NCT02302066|OG003|Outcome|Group 4 (Placebo Control)|Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215868|NCT02302066|OG000|Outcome|Group 1 (TDV 2-Dose) Infant/Toddler|Participants aged <6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215869|NCT02302066|OG001|Outcome|Group 2 (TDV 1-Dose) Infant/Toddler|Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215870|NCT02302066|OG002|Outcome|Group 3 (TDV 2-Dose) Infant/Toddler|Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215871|NCT02302066|OG003|Outcome|Group 4 (Placebo Control) Infant/Toddler|Participants aged <6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215872|NCT02302066|OG000|Outcome|Group 1 (TDV 2-Dose) Adult/Children|Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215873|NCT02302066|OG001|Outcome|Group 2 (TDV 1-Dose) Adult/Children|Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215874|NCT02302066|OG002|Outcome|Group 3 (TDV 1-Dose + Booster) Adult/Children|Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215875|NCT02302066|OG003|Outcome|Group 4 (Placebo Control) Adult/Children|Participant aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215876|NCT02302066|OG002|Outcome|Group 3 (TDV 1-Dose + Booster) Infant/Toddler|Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215877|NCT02302066|OG003|Outcome|Group 4 (Placebo Control) Adult/Children|Participants aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215878|NCT02302066|EG000|Reported Event|Group 1 (TDV 2-Dose)|Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
11215879|NCT02302066|EG001|Reported Event|Group 2 (TDV 1-Dose)|Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
11215880|NCT02302066|EG002|Reported Event|Group 3 (TDV 1-Dose + Booster)|Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
11215881|NCT02302066|EG003|Reported Event|Group 4 (Placebo Control)|Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
11215882|NCT02302092|BG000|Baseline|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
11215883|NCT02302092|BG001|Baseline|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
11215884|NCT02302092|BG002|Baseline|Total|Total of all reporting groups
11215885|NCT02302092|FG000|Participant Flow|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
11215886|NCT02302092|FG001|Participant Flow|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
11215887|NCT02302092|OG000|Outcome|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
11215888|NCT02302092|OG001|Outcome|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
11215889|NCT02302092|EG000|Reported Event|Flomoxef|Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
11215890|NCT02302092|EG001|Reported Event|Cefepime|Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
11215891|NCT02302157|BG000|Baseline|AST-OPC1, Cohort 1|n=3 Dosage of 2 million cells AIS score A
11215892|NCT02302157|BG001|Baseline|AST-OPC1, Cohort 2|n=6 Dosage of 10 million cells AIS score A
11215893|NCT02302157|BG002|Baseline|AST-OPC1, Cohort 3|n=6 Dosage of 20 million cells AIS score A
11215894|NCT02302157|BG003|Baseline|AST-OPC1, Cohort 4|n=6 Dosage of 10 million cells AIS score B
11215895|NCT02302157|BG004|Baseline|AST-OPC1, Cohort 5|n=4 Dosage of 20 million cells AIS score B
11215896|NCT02302157|BG005|Baseline|Total|Total of all reporting groups
11215897|NCT02302157|FG000|Participant Flow|AST-OPC1, Cohort 1|n=3 subjects Dosage of 2 million cells AIS score A
11215898|NCT02302157|FG001|Participant Flow|AST-OPC1, Cohort 2|n=6 subjects Dosage 10 million cells AIS score A
11215899|NCT02302157|FG002|Participant Flow|AST-OPC1, Cohort 3|n=6 subjects Dosage of 20 million cells AIS score A
11215900|NCT02302157|FG003|Participant Flow|AST-OPC1, Cohort 4|n=6 subjects Dosage of 10 million AIS score B
11215901|NCT02302157|FG004|Participant Flow|AST-OPC1, Cohort 5|n=4 subjects Dosage of 20 million cells AIS score B
11215902|NCT02302157|OG000|Outcome|AST-OPC1, Cohort 1|n=3 Dosage of 2 million cells AIS score A
11215903|NCT02302157|OG001|Outcome|AST-OPC1, Cohort 2|n=6 Dosage of 10 million cells AIS score A
11215904|NCT02302157|OG002|Outcome|AST-OPC1, Cohort 3|n=6 Dosage of 20 million cells AIS score A
11215905|NCT02302157|OG003|Outcome|AST-OPC1, Cohort 4|n=6 Dosage of 10 million cells AIS score B
11215906|NCT02302157|OG004|Outcome|AST-OPC1, Cohort 5|n=4 Dosage of 20 million cells AIS score B
11215907|NCT02302157|OG000|Outcome|AST-OPC1, Cohort 1|n=3 Dosage of 2 million AIS A
11215908|NCT02302157|OG001|Outcome|AST-OPC1, Cohort 2|n=6 Dosage of 10 million AIS A
11215909|NCT02302157|OG002|Outcome|AST-OPC1, Cohort 3|n=6 Dosage of 20 million AIS A
11215910|NCT02302157|OG003|Outcome|AST-OPC1, Cohort 4|n=6 Dosage of 10 million AIS B
11289395|NCT02921061|FG000|Participant Flow|Treatment (Decitabine 20 mg/m2 and G-CLAM)|"Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3).~Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM.~Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks)."
11289396|NCT02921061|OG000|Outcome|Treatment (Decitabine 20 mg/m2 and G-CLAM)|"Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3).~Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM.~Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks)."
11289397|NCT02921061|EG000|Reported Event|Treatment (Decitabine 20 mg/m2 and G-CLAM)|"Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3).~Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM.~Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks)."
11289398|NCT02921087|BG000|Baseline|Test Followed by Control|"Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.~Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days~Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days"
11289399|NCT02921087|BG001|Baseline|Control Followed by Test|"Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.~Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days~Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days"
11289400|NCT02921087|BG002|Baseline|Total|Total of all reporting groups
11289401|NCT02921087|FG000|Participant Flow|Test 1 Week, Followed by Control 1 Week, no Washout|"Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.~Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days~Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days"
11289402|NCT02921087|FG001|Participant Flow|Control 1 Week, Followed by Test 1 Week, no Washout|"Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.~Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days~Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days"
11289403|NCT02921087|OG000|Outcome|Test Arm: Multifocal Soft Contact Lenses|Symptoms after one week of wearing multifocal soft spherical contact lenses.
11289404|NCT02921087|OG001|Outcome|Control Arm: Single Vision Spherical Contact Lenses|Symptoms after one week of wearing single vision soft spherical contact lenses.
11289405|NCT02921087|OG002|Outcome|Baseline Symptoms|Symptoms at visit one in habitual contact lenses
11289406|NCT02921087|OG000|Outcome|Preferred Multifocal Lenses|Percentage of subjects who preferred the multifocal (test) lenses
11289407|NCT02921087|OG001|Outcome|Preferred Single Vision Lenses|Percentage of subjects who preferred the single vision (control) lenses
11289408|NCT02921087|OG000|Outcome|Test Arm: Multifocal Soft Contact Lenses|Lag of Accommodation while wearing multifocal soft spherical contact lenses.
11289409|NCT02921087|OG001|Outcome|Control Arm: Single Vision Spherical Contact Lenses|Lag of Accommodation while wearing single vision soft spherical contact lenses.
11289410|NCT02921087|OG000|Outcome|Test Arm: Multifocal Soft Contact Lenses|Near Phoria while wearing multifocal soft spherical contact lenses.
11289411|NCT02921087|OG001|Outcome|Control Arm: Single Vision Spherical Contact Lenses|Near Phoria while wearing single vision soft spherical contact lenses.
11289412|NCT02921087|OG000|Outcome|Phoria in Single Vision Spherical Contact Lenses|Phoria at near as measured through the single vision spherical contact lenses
11289413|NCT02921087|OG000|Outcome|Esophoric at Near|Subjects who are esophoric at near with single vision contact lenses
11289414|NCT02921087|OG001|Outcome|Exophoric or Orthophoria at Near|Subjects who were exophoric or orthophoric at near in single vision contact lenses
11289415|NCT02921087|EG000|Reported Event|Multifocal Contact Lenses|Adverse Events while wearing Multifocal Contact Lenses
11289416|NCT02921087|EG001|Reported Event|Single Vision Contact Lenses|Adverse Events while wearing Single Vision Contact Lenses
11289417|NCT02921295|BG000|Baseline|Sequential Change of Interventions|Conventional Stubby prostheses will be used in this intervention
11289418|NCT02921295|FG000|Participant Flow|Sequential Change of Intervention|Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence
11289419|NCT02921295|OG000|Outcome|Stubbies|Conventional Stubby prostheses as control intervention in cross-over trial
11289420|NCT02921295|OG001|Outcome|Sidekicks|Active intervention in cross-over trial
11289421|NCT02921295|OG000|Outcome|Stubbies|control intervention
11289422|NCT02921295|OG001|Outcome|Sidekicks|active intervention
11289423|NCT02921295|OG000|Outcome|Stubbies|Control intervention
10822184|NCT00075088|BG001|Baseline|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
11215911|NCT02302157|OG004|Outcome|AST-OPC1, Cohort 5|n=4 Dosage of 20 million AIS B
11215912|NCT02302157|EG000|Reported Event|AST-OPC1, Cohort 1|n=3 Dosage of 2 million cells AIS score A
11215913|NCT02302157|EG001|Reported Event|AST-OPC1, Cohort 2|n=6 Dosage of 10 million cells AIS score A
11215914|NCT02302157|EG002|Reported Event|AST-OPC1, Cohort 3|n=6 Dosage of 20 million cells AIS score A
11215915|NCT02302157|EG003|Reported Event|AST-OPC1, Cohort 4|n=6 Dosage of 10 million cells AIS score B
11215916|NCT02302157|EG004|Reported Event|AST-OPC1, Cohort 5|n=4 Dosage of 20 million cells AIS score B
11215917|NCT02302222|BG000|Baseline|Standard of Care|"dry sterile dressing/gauze and steristrips~Standard of Care Dressing"
11215918|NCT02302222|BG001|Baseline|Customizable|"Customizable Dressing with ActiV.A.C. Therapy Unit~Customizable Dressing with ActiV.A.C. Therapy Unit"
11215919|NCT02302222|BG002|Baseline|Total|Total of all reporting groups
11215920|NCT02302222|FG000|Participant Flow|Standard of Care|dry sterile dressing/gauze and steristrips
11215921|NCT02302222|FG001|Participant Flow|Customizable|Customizable Dressing with ActiV.A.C. Therapy Unit
11215922|NCT02302222|OG000|Outcome|Standard of Care|"dry sterile dressing/gauze and steristrips~Standard of Care Dressing"
11215923|NCT02302222|OG001|Outcome|Customizable|"Customizable Dressing with ActiV.A.C. Therapy Unit~Customizable Dressing with ActiV.A.C. Therapy Unit"
11215924|NCT02302222|EG000|Reported Event|Standard of Care|"dry sterile dressing/gauze and steristrips~Standard of Care Dressing"
11215925|NCT02302222|EG001|Reported Event|Customizable|"Customizable Dressing with ActiV.A.C. Therapy Unit~Customizable Dressing with ActiV.A.C. Therapy Unit"
11289424|NCT02921295|EG000|Reported Event|Stubbies|Control intervention
11289425|NCT02921295|EG001|Reported Event|Sidekicks|active intervention
11289426|NCT02921386|BG000|Baseline|Oral Testosterone Undecanoate|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate"
11289427|NCT02921386|FG000|Participant Flow|Oral Testosterone Undecanoate 237 mg BID|Subjects complete Sequence A-E. Amount of Fat Varies by Sequence. Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to breakfast and immediately prior to dinner.
11289428|NCT02921386|OG000|Outcome|Breakfast A - Fasting|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
11289429|NCT02921386|OG001|Outcome|Breakfast B - 15 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
11289430|NCT02921386|OG002|Outcome|Breakfast C - 30 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
11289431|NCT02921386|OG003|Outcome|Breakfast D - 45 g Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
11289432|NCT02921386|OG004|Outcome|Breakfast E - High Fat|"Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner.~Oral Testosterone Undecanoate: All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods"
11289433|NCT02921386|EG000|Reported Event|Oral Testosterone Undecanoate 237 mg BID|Subjects will self-administer 237 mg oral TU BID for a 14 day Run-in Phase, followed by 5 consecutive days of twice daily dosing in a phase 1 clinic for serial PK sampling.
11289434|NCT02921412|BG000|Baseline|Enfilcon A Toric / Fanfilcon A Toric|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
11289435|NCT02921412|FG000|Participant Flow|All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)|All participants wore enfilcon A toric lens (habitual) and then wore fanfilcon A toric lenses for 1 month.
11289436|NCT02921412|OG000|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
11289437|NCT02921412|OG001|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
11289438|NCT02921412|OG002|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
11289439|NCT02921412|OG003|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
10822185|NCT00075088|BG002|Baseline|Total|Total of all reporting groups
11289440|NCT02921412|OG000|Outcome|Enfilcon A Toric (Baseline)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
11289441|NCT02921412|OG001|Outcome|Fanfilcon A Toric (Dispense)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
11289442|NCT02921412|OG002|Outcome|Fanfilcon A Toric (2 Weeks)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
11289443|NCT02921412|OG003|Outcome|Fanfilcon A Toric (1 Month)|All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
11289444|NCT02921412|EG000|Reported Event|All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)|All participants wore enfilcon A toric lenses (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
11289445|NCT02921425|BG000|Baseline|Patient Health Record|"The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.~Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle"
11332487|NCT03496428|BG000|Baseline|Dental Implant Impression Techniques|"Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.~An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined~Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques"
11333875|NCT03520959|OG001|Outcome|CMB305|CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
11333876|NCT03520959|EG000|Reported Event|Placebo|CMB305 placebo control
11289446|NCT02921425|FG000|Participant Flow|Patient Health Record|"The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.~Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle"
11289447|NCT02921425|OG000|Outcome|Patient Health Record|"The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.~Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle"
11289448|NCT02921425|EG000|Reported Event|Patient Health Record|"The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.~Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle"
11289449|NCT02921490|BG000|Baseline|PET/MR Recipients|"All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.~FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine."
11289450|NCT02921490|FG000|Participant Flow|PET/MR Recipients|"All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.~FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine."
11289451|NCT02921490|OG000|Outcome|PET/MR Recipients|"All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.~FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine."
11289452|NCT02921490|EG000|Reported Event|PET/MR Recipients|"All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.~FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine."
11289453|NCT02921737|BG000|Baseline|Treatment Arm|"TAS-102~TAS-102: TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle."
10842431|NCT00246376|OG001|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
10842432|NCT00246376|OG002|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
10842433|NCT00246376|OG003|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
10842434|NCT00246376|OG004|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
10842435|NCT00246376|OG000|Outcome|Group 1 - Usual Care|
10842436|NCT00246376|OG001|Outcome|Group 2 - Diet/Exercise Only|
11289454|NCT02921737|FG000|Participant Flow|Treatment Arm|"TAS-102~TAS-102: TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle."
11289455|NCT02921737|OG000|Outcome|Treatment Arm|"TAS-102~TAS-102: TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle."
11289456|NCT02921737|EG000|Reported Event|Treatment Arm|"TAS-102~TAS-102: TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle."
11289457|NCT02921750|BG000|Baseline|Exufiber|Investigational device: Exufiber Gelling fibre dressing
11289458|NCT02921750|BG001|Baseline|Aquacel|Comparator: Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre
11289459|NCT02921750|BG002|Baseline|Total|Total of all reporting groups
11289460|NCT02921750|FG000|Participant Flow|Exufiber|Investigational Device: Exufiber® gelling fibre dressing as primary dressing to facilitate moist healing of venous leg ulcer.
11289461|NCT02921750|FG001|Participant Flow|Aquacel|Comparator - Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre as primary dressing to facilitate moist healing of venous leg ulcer.
11289462|NCT02921750|OG000|Outcome|Exufiber|Investigational device, Exufiber Gelling Fibre Dressing
11289463|NCT02921750|OG001|Outcome|Aquacel|Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
11289464|NCT02921750|OG000|Outcome|Exufiber|Investigational Device, Exufiber Gelling Fibre Dressing
11289465|NCT02921750|OG000|Outcome|Exufiber|Investigational device, Exufiber Gelling fibre dressing
11289466|NCT02921750|OG001|Outcome|Aquacel|Comparator Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
11289467|NCT02921750|EG000|Reported Event|Exufiber|Investigational device, Exufiber Gelling fibre dressing
11289468|NCT02921750|EG001|Reported Event|Aquacel|Comparator, Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre
11289469|NCT02921841|BG000|Baseline|DSTAR|Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
11289470|NCT02921841|BG001|Baseline|DHEALTH|Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
11289471|NCT02921841|BG002|Baseline|Total|Total of all reporting groups
10822186|NCT00075088|FG000|Participant Flow|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
10822187|NCT00075088|FG001|Participant Flow|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
10842437|NCT00246376|OG002|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
11289472|NCT02921841|FG000|Participant Flow|DSTAR|Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
11289473|NCT02921841|FG001|Participant Flow|DHEALTH|Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
11289474|NCT02921841|OG000|Outcome|DSTAR|Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
11289475|NCT02921841|OG001|Outcome|DHEALTH|Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
11289476|NCT02921841|EG000|Reported Event|DSTAR|Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
11289477|NCT02921841|EG001|Reported Event|DHEALTH|Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
11289478|NCT02922153|BG000|Baseline|Cryoanalgesia + Standard of Care (SOC)|"Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.~Cryoanalgesia: AtriCure® cryoICE cryo-ablation system~Standard of Care: Institutional SOC for pain management will be followed."
11289479|NCT02922153|BG001|Baseline|Standard of Care|"Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.~Standard of Care: Institutional SOC for pain management will be followed."
11289480|NCT02922153|BG002|Baseline|Total|Total of all reporting groups
11289481|NCT02922153|FG000|Participant Flow|Cryoanalgesia + Standard of Care (SOC)|"Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.~Cryoanalgesia: AtriCure® cryoICE cryo-ablation system~Standard of Care: Institutional SOC for pain management will be followed."
11289482|NCT02922153|FG001|Participant Flow|Standard of Care|"Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.~Standard of Care: Institutional SOC for pain management will be followed."
11289483|NCT02922153|OG000|Outcome|Cryoanalgesia + SOC|"Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.~Cryoanalgesia: AtriCure® cryoICE cryo-ablation system~Standard of Care: Institutional SOC for pain management will be followed."
11289484|NCT02922153|OG001|Outcome|Standard of Care|"Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.~Standard of Care: Institutional SOC for pain management will be followed."
11289485|NCT02922153|EG000|Reported Event|Cryoanalgesia + SOC|"Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.~Cryoanalgesia: AtriCure® cryoICE cryo-ablation system~Standard of Care: Institutional SOC for pain management will be followed."
11289486|NCT02922153|EG001|Reported Event|Standard of Care|"Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.~Standard of Care: Institutional SOC for pain management will be followed."
11289487|NCT02922582|BG000|Baseline|DepoTXA 400mg|Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
11289488|NCT02922582|BG001|Baseline|DepoTXA 800mg|Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
11289489|NCT02922582|BG002|Baseline|DepoTXA 1200mg|Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
11289490|NCT02922582|BG003|Baseline|IV Tranexamic Acid (TXA)|1 g of IV TXA at the end of surgery
11289491|NCT02922582|BG004|Baseline|Total|Total of all reporting groups
11289492|NCT02922582|FG000|Participant Flow|DepoTXA 400mg|Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
11289493|NCT02922582|FG001|Participant Flow|DepoTXA 800mg|Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
11289494|NCT02922582|FG002|Participant Flow|DepoTXA 1200mg|Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
11289495|NCT02922582|FG003|Participant Flow|IV Tranexamic Acid (TXA)|1 g of IV TXA at the end of surgery
11289496|NCT02922582|OG000|Outcome|DepoTXA 400mg|Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
11289497|NCT02922582|OG001|Outcome|DepoTXA 800mg|Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
11289498|NCT02922582|OG002|Outcome|DepoTXA 1200mg|Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
11289499|NCT02922582|OG003|Outcome|IV Tranexamic Acid (TXA)|1 g of IV TXA at the end of surgery
11289500|NCT02922582|EG000|Reported Event|DepoTXA 400mg|Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
11289501|NCT02922582|EG001|Reported Event|DepoTXA 800mg|Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
11289502|NCT02922582|EG002|Reported Event|DepoTXA 1200mg|Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
11289503|NCT02922582|EG003|Reported Event|IV Tranexamic Acid (TXA)|1 g of IV TXA at the end of surgery
11289504|NCT02922634|BG000|Baseline|Older Surgical Patients|"Older surgical patients presenting for elective spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr. Chi~Mini Cog: short cognitive screen, short Frailty screen"
11289505|NCT02922634|FG000|Participant Flow|Older Surgical Patients Having Spine Surgery|Older surgical patients (≥ 70 years of age) presenting for elective spine surgery.
11289506|NCT02922634|OG000|Outcome|No Delirium|Older surgical patients presenting for elective spine surgery that did not develop post-op delirium
11289507|NCT02922634|OG001|Outcome|Delirium|Older surgical patients presenting for elective spine surgery that did develop post-op delirium
11289508|NCT02922634|OG000|Outcome|No Delirium|Older surgical patients presenting for elective spine surgery with an ASA Physical that did not develop post-op delirium
11289509|NCT02922634|OG001|Outcome|Delirium|Older surgical patients presenting for elective spine surgery with an ASA physical status of that did develop post-op delirium
11289510|NCT02922634|OG000|Outcome|No Delirium|Older spine surgery patients who did not develop post-operative delirium
11289511|NCT02922634|OG001|Outcome|Delirium|Older spine surgery patients who did develop post-operative delirium
11289512|NCT02922634|OG000|Outcome|In Hospital Complications|Patients that experienced in hospital complications not including post-operative delirium.
11289513|NCT02922634|OG000|Outcome|Discharge Location|Discharge location (home vs place other than home) for patients who participated in this study.
11289514|NCT02922634|EG000|Reported Event|Postoperative Outcomes in Older Patients After Spine Surgery|Older surgical patients that had elective spine surgery and developed an in-hospital cardiopulmonary, infectious, renal or cerebrovascular complication.
11289515|NCT02922738|BG000|Baseline|Intervention - VisualDx Arm|Providers referred to VisualDx when seeing a patient with a skin problem. Patients with skin problem were interviewed for outcomes data.
11289516|NCT02922738|BG001|Baseline|Control - Usual Care Arm|Providers ddi not refer to VisualDx but could refer to other resources or none per usual care.
11289517|NCT02922738|BG002|Baseline|Total|Total of all reporting groups
11289518|NCT02922738|FG000|Participant Flow|Intervention - VisualDx Arm|Providers (clusters) randomized to use VisualDx when seeing a patient that presented with a skin problem. Their patients, seen for a skin problem were interviewed for outcome data.
11289519|NCT02922738|FG001|Participant Flow|Control: Usual Care Arm|Control providers (clusters) did not use VisualDx but could refer to other information sources or none in usual care.
11289520|NCT02922738|OG000|Outcome|Intervention - Used VisualDx|"Providers referred to VisualDx when seeing a patient that presented with a skin problem. Patients were interviewed about the outcome of their treatment. Patients were allocated to the randomization group of the PCP they saw.~VisualDx: VisualDx is a computerized clinical information technology with medical image and text content in dermatology."
11289521|NCT02922738|OG001|Outcome|Control - Usual Care|Providers did not use VisualDx but may have referred to other information sources or none (usual care). Patients were allocated to the randomization group of the PCP they saw.Patients were interviewed about the outcome of their treatment.
11289522|NCT02922738|OG000|Outcome|Intervention - Used VisualDx|"Providers referred to VisualDx when seeing a patient that presented with a skin problem. Patients were interviewed about the outcome of their treatment. Patients were allocated to the randomization group of the PCP they saw.~VisualDx: VisualDx is a computerized clinical information technology with medical image and text content in dermatology.~Providers were the subjects of randomization. Patients were the subjects of analysis."
11289523|NCT02922738|OG001|Outcome|Control - Usual Care|"Providers did not use VisualDx but may have referred to other information sources or none (usual care). Patients were allocated to the randomization group of the PCP they saw.Patients were interviewed about the outcome of their treatment.~Providers were the subjects of randomization. Patients were the subjects of analysis."
11289524|NCT02922738|EG000|Reported Event|Intervention - Used VisualDx|"Providers referred to VisualDx when seeing a patient that presented with a skin problem. Patients were interviewed about the outcome of their treatment. Patients were allocated to the randomization group of the PCP they saw.~VisualDx: VisualDx is a computerized clinical information technology with medical image and text content in dermatology.~Providers were the subjects of randomization. Patients were the subjects of analysis.~There were no adverse events reported."
11289525|NCT02922738|EG001|Reported Event|Control - Usual Care|"Providers did not use VisualDx but may have referred to other information sources or none (usual care). Patients were allocated to the randomization group of the PCP they saw.Patients were interviewed about the outcome of their treatment.~Providers were the subjects of randomization. Patients were the subjects of analysis.~There were no adverse events reported."
11289526|NCT02922868|BG000|Baseline|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
11289527|NCT02922868|BG001|Baseline|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
11289528|NCT02922868|BG002|Baseline|Total|Total of all reporting groups
11289529|NCT02922868|FG000|Participant Flow|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
11289530|NCT02922868|FG001|Participant Flow|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
11289531|NCT02922868|OG000|Outcome|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
11289532|NCT02922868|OG001|Outcome|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
11289533|NCT02922868|EG000|Reported Event|EndoSheath CST-5000 Scope|"Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.~EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope."
11289534|NCT02922868|EG001|Reported Event|Olympus Visera Elite OTV-S190 Scope|"Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.~Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope"
11289535|NCT02922959|BG000|Baseline|PTOEND|"PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.~Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289536|NCT02922959|BG001|Baseline|PTOEND+PI|"PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.~In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.~Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289537|NCT02922959|BG002|Baseline|Total|Total of all reporting groups
11289538|NCT02922959|FG000|Participant Flow|PTOEND|"PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.~Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289539|NCT02922959|FG001|Participant Flow|PTOEND+PI|"PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.~In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.~Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289540|NCT02922959|OG000|Outcome|PTOEND|"PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.~Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
10842438|NCT00246376|OG003|Outcome|Group 4 - Diet/Exercise + Niacin|
10822188|NCT00075088|OG000|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
10822189|NCT00075088|OG001|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
11215926|NCT02302339|BG000|Baseline|Glembatumumab Vedotin|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.~glembatumumab vedotin"
11215927|NCT02302339|BG001|Baseline|Glembatumumab Vedotin and Varlilumab|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.~glembatumumab vedotin and varlilumab"
11215928|NCT02302339|BG002|Baseline|Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.~glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)"
11215929|NCT02302339|BG003|Baseline|Glembatumumab Vedotin and CDX-301|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.~glembatumumab vedotin and CDX-301"
11215930|NCT02302339|BG004|Baseline|Total|Total of all reporting groups
11215931|NCT02302339|FG000|Participant Flow|Glembatumumab Vedotin|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.~glembatumumab vedotin"
11215932|NCT02302339|FG001|Participant Flow|Glembatumumab Vedotin and Varlilumab|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.~glembatumumab vedotin and varlilumab"
11215933|NCT02302339|FG002|Participant Flow|Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.~glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)"
11215934|NCT02302339|FG003|Participant Flow|Glembatumumab Vedotin and CDX-301|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.~glembatumumab vedotin and CDX-301"
11215935|NCT02302339|OG000|Outcome|Glembatumumab Vedotin|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.~glembatumumab vedotin"
11215936|NCT02302339|OG001|Outcome|Glembatumumab Vedotin and Varlilumab|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.~glembatumumab vedotin and varlilumab"
11215937|NCT02302339|OG002|Outcome|Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.~glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)"
11215938|NCT02302339|OG003|Outcome|Glembatumumab Vedotin and CDX-301|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.~glembatumumab vedotin and CDX-301"
11215939|NCT02302339|OG000|Outcome|Glembatumumab Vedotin and CDX-301|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.~glembatumumab vedotin and CDX-301"
11215940|NCT02302339|EG000|Reported Event|Glembatumumab Vedotin|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.~glembatumumab vedotin"
11215941|NCT02302339|EG001|Reported Event|Glembatumumab Vedotin and Varlilumab|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.~glembatumumab vedotin and varlilumab"
11215942|NCT02302339|EG002|Reported Event|Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.~glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)"
11215943|NCT02302339|EG003|Reported Event|Glembatumumab Vedotin and CDX-301|"glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.~glembatumumab vedotin and CDX-301"
11215944|NCT02302365|BG000|Baseline|Subjects Who Received At Least 1 WBCD Apheresis Procedure|Eligible subjects who received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
11215945|NCT02302365|FG000|Participant Flow|Subjects Who Received a Minimum of 1 WBCD Procedure|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
11215946|NCT02302365|OG000|Outcome|WBCD Procedures Performed|Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients
11215947|NCT02302365|OG000|Outcome|Safety Data Collection 0-2 Hours Post Apheresis Procedure|58 WBCD procedures were performed in 43 patients. Safety data was collected for up to 2 hours post apheresis procedure
11215948|NCT02302365|OG001|Outcome|Safety Data Collection 0-24 Hours Post Apheresis Procedure|41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
11215949|NCT02302365|OG000|Outcome|WBCD Procedures Performed|58 WBCD procedures were performed in 43 patients.
11215950|NCT02302365|EG000|Reported Event|0-2 Hour Safety Data Collection|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 2 hours post apheresis procedure
11215951|NCT02302365|EG001|Reported Event|0-24 Hour Safety Data Collection|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 24 hours post apheresis procedure
11333877|NCT03520959|EG001|Reported Event|CMB305|CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
11333878|NCT03520998|BG000|Baseline|GRF6019 Low Dose|Low dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11289541|NCT02922959|OG001|Outcome|PTOEND+PI|"PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.~In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.~Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289542|NCT02922959|EG000|Reported Event|PTOEND|"PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.~Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289543|NCT02922959|EG001|Reported Event|PTOEND+PI|"PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.~In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.~Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.~naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.~Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder."
11289544|NCT02923115|BG000|Baseline|Cohort 1: DS-1040b 20 mg|Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289545|NCT02923115|BG001|Baseline|Cohort 2: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289546|NCT02923115|BG002|Baseline|Cohort 3: DS-1040b 60 mg|Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289547|NCT02923115|BG003|Baseline|Cohort 4: DS-1040b 80 mg|Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289548|NCT02923115|BG004|Baseline|Cohort 5: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289549|NCT02923115|BG005|Baseline|Placebo|Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
10822190|NCT00075088|EG000|Reported Event|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
10822191|NCT00075088|EG001|Reported Event|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
11289550|NCT02923115|BG006|Baseline|Total|Total of all reporting groups
11289551|NCT02923115|FG000|Participant Flow|Cohort 1: DS-1040b 20 mg|Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289552|NCT02923115|FG001|Participant Flow|Cohort 2: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289553|NCT02923115|FG002|Participant Flow|Cohort 3: DS-1040b 60 mg|Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289554|NCT02923115|FG003|Participant Flow|Cohort 4: DS-1040b 80 mg|Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289555|NCT02923115|FG004|Participant Flow|Cohort 5: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289556|NCT02923115|FG005|Participant Flow|Placebo|Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
11289557|NCT02923115|OG000|Outcome|Cohort 1: DS-1040b 20 mg|Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289558|NCT02923115|OG001|Outcome|Cohort 2: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289559|NCT02923115|OG002|Outcome|Cohort 3: DS-1040b 60 mg|Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289560|NCT02923115|OG003|Outcome|Cohort 4: DS-1040b 80 mg|Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289561|NCT02923115|OG004|Outcome|Cohort 5: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289562|NCT02923115|OG005|Outcome|Placebo|Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
11289563|NCT02923115|EG000|Reported Event|Cohort 1: DS-1040b 20 mg|Participants who received an intravenous infusion of 20 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289564|NCT02923115|EG001|Reported Event|Cohort 2: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289565|NCT02923115|EG002|Reported Event|Cohort 3: DS-1040b 60 mg|Participants who received an intravenous infusion of 60 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289566|NCT02923115|EG003|Reported Event|Cohort 4: DS-1040b 80 mg|Participants who received an intravenous infusion of 80 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289567|NCT02923115|EG004|Reported Event|Cohort 5: DS-1040b 40 mg|Participants who received an intravenous infusion of 40 mg DS-1040b in addition to standard of care anticoagulation therapy.
11289568|NCT02923115|EG005|Reported Event|Placebo|Participants who received an intravenous infusion of placebo in addition to standard of care anticoagulation therapy.
11289569|NCT02923167|BG000|Baseline|Robotic-assisted Training of the Hand|Robotic-assisted training of the hand: Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
10822192|NCT00075088|EG002|Reported Event|Prehospital|"At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but NA is not a valid entry in the At Risk field."
10842439|NCT00246376|OG004|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
11289570|NCT02923167|FG000|Participant Flow|Robotic-assisted Training of the Hand|Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
11289571|NCT02923167|OG000|Outcome|Robotic-assisted Training of the Hand|Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
11289572|NCT02923167|OG000|Outcome|Robotic-assisted Training of the Hand|Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
11289573|NCT02923167|EG000|Reported Event|Robotic-assisted Training of the Hand|Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
11289574|NCT02923180|BG000|Baseline|Enoblituzumab|Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.
11289575|NCT02923180|FG000|Participant Flow|Enoblituzumab|Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.
11289576|NCT02923180|OG000|Outcome|Enoblituzumab|Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.
11289577|NCT02923180|EG000|Reported Event|Enoblituzumab|Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.
11289578|NCT02923245|BG000|Baseline|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
11289579|NCT02923245|BG001|Baseline|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
11289580|NCT02923245|BG002|Baseline|Total|Total of all reporting groups
11289581|NCT02923245|FG000|Participant Flow|Point-of-care Ultrasound (POCUS)|"Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the emergency department (ED) physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
11289582|NCT02923245|FG001|Participant Flow|Usual Care (UC)|Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
11289583|NCT02923245|OG000|Outcome|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
11289584|NCT02923245|OG001|Outcome|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
11289585|NCT02923245|OG000|Outcome|Bladder POCUS Images|all saved POCUS images were de-identified and retrospectively reviewed by the study site's Director of Pediatric Emergency Ultrasound. The reviewer, blinded to the original assessment of the study sonographer, rated each image as small, medium, large, or unidentifiable.
11289586|NCT02923245|EG000|Reported Event|POCUS|"Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.~point-of-care ultrasound"
11289587|NCT02923245|EG001|Reported Event|Usual Care|Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
11333879|NCT03520998|BG001|Baseline|GRF6019 High Dose|High dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11333880|NCT03520998|BG002|Baseline|Total|Total of all reporting groups
10822193|NCT00075218|BG000|Baseline|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
10822194|NCT00075218|BG001|Baseline|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
10822195|NCT00075218|BG002|Baseline|Total|Total of all reporting groups
11289588|NCT02923271|BG000|Baseline|Teen-Parent Monitoring Group|Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa. Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. CellControl: Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks
11289589|NCT02923271|BG001|Baseline|Teen Only Monitoring Group|Cellcontrol DriveID device will automatically turn on when teen or parent begins driving blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use.Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology. CellControl: see other arm
11289590|NCT02923271|BG002|Baseline|Total|Total of all reporting groups
11289591|NCT02923271|FG000|Participant Flow|Teen-Parent Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl: Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks"
11289592|NCT02923271|FG001|Participant Flow|Teen Only Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl:"
11289593|NCT02923271|OG000|Outcome|Teen-Parent Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl: Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks"
11289594|NCT02923271|OG001|Outcome|Teen Only Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl:"
11289595|NCT02923271|EG000|Reported Event|Teen-Parent Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl: Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks"
11333881|NCT03520998|FG000|Participant Flow|GRF6019 Low Dose|Low dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11333882|NCT03520998|FG001|Participant Flow|GRF6019 High Dose|High dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11289596|NCT02923271|EG001|Reported Event|Teen Only Monitoring Group|"Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use.~Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.~CellControl:"
11289597|NCT02923349|BG000|Baseline|PART 1 Dose 1 (7 mg)|INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289598|NCT02923349|BG001|Baseline|PART 1 Dose 2 (20 mg)|INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289599|NCT02923349|BG002|Baseline|PART 1 Dose 3 (70 mg)|INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289600|NCT02923349|BG003|Baseline|PART 1 Dose 4 (200 mg)|INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289601|NCT02923349|BG004|Baseline|PART 1 Dose 5 (350 mg)|INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289602|NCT02923349|BG005|Baseline|PART 1 Dose 6 (700 mg)|INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289603|NCT02923349|BG006|Baseline|PART 1 Dose 7 (1400 mg)|INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289604|NCT02923349|BG007|Baseline|Total|Total of all reporting groups
11289605|NCT02923349|FG000|Participant Flow|PART 1 Dose 1 (7 mg)|INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289606|NCT02923349|FG001|Participant Flow|PART 1 Dose 2 (20 mg)|INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289607|NCT02923349|FG002|Participant Flow|PART 1 Dose 3 (70 mg)|INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289608|NCT02923349|FG003|Participant Flow|PART 1 Dose 4 (200 mg)|INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
10842440|NCT00246376|OG001|Outcome|Group 2 - Diet/Exercise|
11289609|NCT02923349|FG004|Participant Flow|PART 1 Dose 5 (350 mg)|INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289610|NCT02923349|FG005|Participant Flow|PART 1 Dose 6 (700 mg)|INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289611|NCT02923349|FG006|Participant Flow|PART 1 Dose 7 (1400 mg)|INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289612|NCT02923349|OG000|Outcome|PART 1 Dose 1 (7 mg)|INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289613|NCT02923349|OG001|Outcome|PART 1 Dose 2 (20 mg)|INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289614|NCT02923349|OG002|Outcome|PART 1 Dose 3 (70 mg)|INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289615|NCT02923349|OG003|Outcome|PART 1 Dose 4 (200 mg)|INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289616|NCT02923349|OG004|Outcome|PART 1 Dose 5 (350 mg)|INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289617|NCT02923349|OG005|Outcome|PART 1 Dose 6 (700 mg)|INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289618|NCT02923349|OG006|Outcome|PART 1 Dose 7 (1400 mg)|INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289619|NCT02923349|EG000|Reported Event|PART 1 Dose 1 (7 mg)|INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289620|NCT02923349|EG001|Reported Event|PART 1 Dose 2 (20 mg)|INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289621|NCT02923349|EG002|Reported Event|PART 1 Dose 3 (70 mg)|INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289622|NCT02923349|EG003|Reported Event|PART 1 Dose 4 (200 mg)|INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289623|NCT02923349|EG004|Reported Event|PART 1 Dose 5 (350 mg)|INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289624|NCT02923349|EG005|Reported Event|PART 1 Dose 6 (700 mg)|INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11289625|NCT02923349|EG006|Reported Event|PART 1 Dose 7 (1400 mg)|INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
11333883|NCT03520998|OG000|Outcome|GRF6019 Low Dose|Low dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11289626|NCT02923427|BG000|Baseline|Laryngeal Mask Supreme|"Insertion of the Laryngeal mask Supreme and evaluation of its clinical performance~Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications"
11289627|NCT02923427|BG001|Baseline|I-gel|"Insertion of the i-gel and evaluation of its clinical performance~i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications"
11289628|NCT02923427|BG002|Baseline|Total|Total of all reporting groups
10822196|NCT00075218|FG000|Participant Flow|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
10842441|NCT00246376|EG000|Reported Event|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
11289629|NCT02923427|FG000|Participant Flow|Laryngeal Mask Supreme|"Insertion of the Laryngeal mask Supreme and evaluation of its clinical performance~Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications"
11289630|NCT02923427|FG001|Participant Flow|I-gel|"Insertion of the i-gel and evaluation of its clinical performance~i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications"
11333884|NCT03520998|OG001|Outcome|GRF6019 High Dose|High dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11333885|NCT03520998|EG000|Reported Event|GRF6019 Low Dose|Low dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11333886|NCT03520998|EG001|Reported Event|GRF6019 High Dose|High dose of GRF6019 for 5 consecutive days at Weeks 1 and 13
11333887|NCT03521089|BG000|Baseline|Active tDCS|Active tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The active tDCS intervention include stimulation for 15 minutes at 1mA. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333888|NCT03521089|BG001|Baseline|Sham tDCS|Sham tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The sham tDCS intervention lasts for 15 minutes. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333889|NCT03521089|BG002|Baseline|Total|Total of all reporting groups
11333890|NCT03521089|FG000|Participant Flow|Active tDCS|Active tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The active tDCS intervention include stimulation for 15 minutes at 1mA. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333891|NCT03521089|FG001|Participant Flow|Sham tDCS|Sham tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The sham tDCS intervention lasts for 15 minutes. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333892|NCT03521089|OG000|Outcome|Active tDCS|Active tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The active tDCS intervention include stimulation for 15 minutes at 1mA. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333893|NCT03521089|OG001|Outcome|Sham tDCS|Sham tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The sham tDCS intervention lasts for 15 minutes. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333894|NCT03521089|EG000|Reported Event|Active tDCS|Active tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The active tDCS intervention include stimulation for 15 minutes at 1mA. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11333895|NCT03521089|EG001|Reported Event|Sham tDCS|Sham tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The sham tDCS intervention lasts for 15 minutes. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
11336291|NCT03565068|OG007|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11336292|NCT03565068|OG008|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
11289631|NCT02923427|OG000|Outcome|Laryngeal Mask Supreme|"Insertion of the Laryngeal mask Supreme and evaluation of its clinical performance~Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications"
11289632|NCT02923427|OG001|Outcome|I-gel|"Insertion of the i-gel and evaluation of its clinical performance~i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications"
11289633|NCT02923427|EG000|Reported Event|Laryngeal Mask Supreme|"Insertion of the Laryngeal mask Supreme and evaluation of its clinical performance~Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications"
11289634|NCT02923427|EG001|Reported Event|I-gel|"Insertion of the i-gel and evaluation of its clinical performance~i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications"
11289635|NCT02923895|BG000|Baseline|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.
11289636|NCT02923895|BG001|Baseline|Control Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
11289637|NCT02923895|BG002|Baseline|Total|Total of all reporting groups
11289638|NCT02923895|FG000|Participant Flow|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.
11289639|NCT02923895|FG001|Participant Flow|Control Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
11289640|NCT02923895|OG000|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.
11289641|NCT02923895|OG001|Outcome|Control Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
11289642|NCT02923895|EG000|Reported Event|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.
11289643|NCT02923895|EG001|Reported Event|Control Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then brushed the whole mouth thoroughly for at least 1 minute twice daily.
11289644|NCT02923921|BG000|Baseline|Pegilodecakin + FOLFOX|Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
11289645|NCT02923921|BG001|Baseline|FOLFOX|FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
11289646|NCT02923921|BG002|Baseline|Total|Total of all reporting groups
11289647|NCT02923921|FG000|Participant Flow|Pegilodecakin + FOLFOX|Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (>) 80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
11289648|NCT02923921|FG001|Participant Flow|FOLFOX|FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
11289649|NCT02923921|OG000|Outcome|Pegilodecakin + FOLFOX|Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
11289650|NCT02923921|OG001|Outcome|FOLFOX|FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
11289651|NCT02923921|EG000|Reported Event|Pegilodecakin + FOLFOX|Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
11289652|NCT02923921|EG001|Reported Event|FOLFOX|FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
11289653|NCT02924051|BG000|Baseline|Control|Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
11289654|NCT02924051|BG001|Baseline|Intervention|"Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289655|NCT02924051|BG002|Baseline|Total|Total of all reporting groups
11289656|NCT02924051|FG000|Participant Flow|Cooking Skills/Nutrition Education|Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.
11289657|NCT02924051|FG001|Participant Flow|Cooking Skills/Nutrition Education/Motivational Interviewing|"Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289658|NCT02924051|OG000|Outcome|Cooking Skills/Nutrition Education|Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
11289659|NCT02924051|OG001|Outcome|Cooking Skills/Nutrition Education/Motivational Interviewing|"Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289660|NCT02924051|OG000|Outcome|Cooking Skills/Nutrition Education|"Participants in the control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289661|NCT02924051|OG001|Outcome|Cooking Skills/Nutrition Education/MI|"Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289662|NCT02924051|EG000|Reported Event|Control|Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.
11289663|NCT02924051|EG001|Reported Event|Intervention|"Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.~Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
11289664|NCT02924350|BG000|Baseline|Test Dentifrice Containing Stannous Fluoride|All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289665|NCT02924350|BG001|Baseline|Control Dentifrice Containing Sodium Monofluorophosphate|All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289666|NCT02924350|BG002|Baseline|Total|Total of all reporting groups
11289667|NCT02924350|FG000|Participant Flow|Test Dentifrice Containing Stannous Fluoride|All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289668|NCT02924350|FG001|Participant Flow|Control Dentifrice Containing Sodium Monofluorophosphate|All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289669|NCT02924350|OG000|Outcome|Test Dentifrice Containing Stannous Fluoride|All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289670|NCT02924350|OG001|Outcome|Control Dentifrice Containing Sodium Monofluorophosphate|All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11336293|NCT03565068|OG009|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11289671|NCT02924350|EG000|Reported Event|Test Dentifrice Containing Stannous Fluoride|All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289672|NCT02924350|EG001|Reported Event|Control Dentifrice Containing Sodium Monofluorophosphate|All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
11289673|NCT02924428|BG000|Baseline|Diamondpolar Applicator, AC Dual Applicator|"Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289674|NCT02924428|BG001|Baseline|AC Dual Applicator|"Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289675|NCT02924428|BG002|Baseline|Total|Total of all reporting groups
11289676|NCT02924428|FG000|Participant Flow|Diamondpolar Applicator, AC Dual Applicator|"Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289677|NCT02924428|FG001|Participant Flow|AC Dual Applicator|"Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289678|NCT02924428|OG000|Outcome|Diamondpolar Applicator, AC Dual Applicator|"Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289679|NCT02924428|OG001|Outcome|AC Dual Applicator|"Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289680|NCT02924428|EG000|Reported Event|Diamondpolar Applicator, AC Dual Applicator|"Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
11289681|NCT02924428|EG001|Reported Event|AC Dual Applicator|"Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.~The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm."
10842442|NCT00246376|EG001|Reported Event|Group 2: Diet / Exercise|Diet, exercise, and two placebos
10842443|NCT00246376|EG002|Reported Event|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
10842444|NCT00246376|EG003|Reported Event|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
10842445|NCT00246376|EG004|Reported Event|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
10842446|NCT00246441|BG000|Baseline|Paroxetine|"Paroxetine~Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"
11289682|NCT02924688|BG000|Baseline|FF/VI 100/25 mcg|Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289683|NCT02924688|BG001|Baseline|FF/UMEC/VI 100/ 31.25/25 mcg|Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289684|NCT02924688|BG002|Baseline|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289685|NCT02924688|BG003|Baseline|FF/VI 200/25 mcg|Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289686|NCT02924688|BG004|Baseline|FF/UMEC/VI 200/ 31.25/25 mcg|Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289687|NCT02924688|BG005|Baseline|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289688|NCT02924688|BG006|Baseline|Total|Total of all reporting groups
11289689|NCT02924688|FG000|Participant Flow|FF/VI 100/25 mcg|Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289690|NCT02924688|FG001|Participant Flow|FF/UMEC/VI 100/ 31.25/25 mcg|Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289691|NCT02924688|FG002|Participant Flow|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289692|NCT02924688|FG003|Participant Flow|FF/VI 200/25 mcg|Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289693|NCT02924688|FG004|Participant Flow|FF/UMEC/VI 200/ 31.25/25 mcg|Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289694|NCT02924688|FG005|Participant Flow|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289695|NCT02924688|OG000|Outcome|FF/VI 100/25 mcg|Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289696|NCT02924688|OG001|Outcome|FF/UMEC/VI 100/ 31.25/25 mcg|Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
11289697|NCT02924688|OG002|Outcome|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289698|NCT02924688|OG003|Outcome|FF/VI 200/25 mcg|Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289699|NCT02924688|OG004|Outcome|FF/UMEC/VI 200/ 31.25/25 mcg|Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289700|NCT02924688|OG005|Outcome|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289701|NCT02924688|OG000|Outcome|FF/VI|Participants received FF/VI 100/25 mcg or 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289702|NCT02924688|OG001|Outcome|FF/UMEC/VI (UMEC 31.25 mcg)|Participants received FF/UMEC/VI 100/31.25/25 mcg or 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289703|NCT02924688|OG002|Outcome|FF/UMEC/VI (UMEC 62.5 mcg)|Participants received FF/UMEC/VI 100/62.5/25 mcg or 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289704|NCT02924688|EG000|Reported Event|FF/VI 100/25 mcg|Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289705|NCT02924688|EG001|Reported Event|FF/UMEC/VI 100/ 31.25/25 mcg|Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289706|NCT02924688|EG002|Reported Event|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289707|NCT02924688|EG003|Reported Event|FF/VI 200/25 mcg|Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289708|NCT02924688|EG004|Reported Event|FF/UMEC/VI 200/ 31.25/25 mcg|Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289709|NCT02924688|EG005|Reported Event|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
11289710|NCT02924883|BG000|Baseline|Trastuzumab Emtansine + Atezolizumab|Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
11289711|NCT02924883|BG001|Baseline|Trastuzumab Emtansine + Placebo|Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
11289712|NCT02924883|BG002|Baseline|Total|Total of all reporting groups
11289713|NCT02924883|FG000|Participant Flow|Trastuzumab Emtansine + Atezolizumab|Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
11289714|NCT02924883|FG001|Participant Flow|Trastuzumab Emtansine + Placebo|Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
11289715|NCT02924883|OG000|Outcome|Trastuzumab Emtansine + Placebo|Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
11289716|NCT02924883|OG001|Outcome|Trastuzumab Emtansine + Atezolizumab|Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
11289717|NCT02924883|OG000|Outcome|Trastuzumab Emtansine + Atezolizumab|Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
11289718|NCT02924883|OG001|Outcome|Trastuzumab Emtansine + Placebo|Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
11289719|NCT02924883|EG000|Reported Event|Trastuzumab Emtansine + Atezolizumab|Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
11289720|NCT02924883|EG001|Reported Event|Trastuzumab Emtansine + Placebo|Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
11289721|NCT02925078|BG000|Baseline|<2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289722|NCT02925078|BG001|Baseline|≥2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289723|NCT02925078|BG002|Baseline|Total|Total of all reporting groups
11289724|NCT02925078|FG000|Participant Flow|<2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289725|NCT02925078|FG001|Participant Flow|≥2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289726|NCT02925078|OG000|Outcome|<2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289727|NCT02925078|OG001|Outcome|≥2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289728|NCT02925078|EG000|Reported Event|<2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289729|NCT02925078|EG001|Reported Event|≥2 mm Mucosa Thickness|"A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.~Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT): Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness."
11289730|NCT02925117|BG000|Baseline|Placebo|Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
11289731|NCT02925117|BG001|Baseline|Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
11289732|NCT02925117|BG002|Baseline|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
11289733|NCT02925117|BG003|Baseline|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
11289734|NCT02925117|BG004|Baseline|Total|Total of all reporting groups
11289735|NCT02925117|FG000|Participant Flow|Placebo|Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.
11289736|NCT02925117|FG001|Participant Flow|Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.
11289737|NCT02925117|FG002|Participant Flow|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.
11289738|NCT02925117|FG003|Participant Flow|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.
11289739|NCT02925117|FG004|Participant Flow|Placebo / Placebo|Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289740|NCT02925117|FG005|Participant Flow|Placebo / Upadacitinib 30 mg|Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
11289741|NCT02925117|FG006|Participant Flow|Upadacitinib 7.5 mg / Placebo|Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289742|NCT02925117|FG007|Participant Flow|Upadacitinib 7.5 mg / Upadacitinib 7.5 mg|Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
11289743|NCT02925117|FG008|Participant Flow|Upadacitinib 15 mg / Placebo|Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289744|NCT02925117|FG009|Participant Flow|Upadacitinib 15 mg / Upadacitinib 15 mg|Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
11289745|NCT02925117|FG010|Participant Flow|Upadacitinib 30 mg / Placebo|Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289746|NCT02925117|FG011|Participant Flow|Upadacitinib 30 mg / Upadacitinib 30 mg|Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
11289747|NCT02925117|OG000|Outcome|Placebo|Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
11289748|NCT02925117|OG001|Outcome|Upadacitinib 7.5 mg|Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
11289749|NCT02925117|OG002|Outcome|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
11289750|NCT02925117|OG003|Outcome|Upadacitinib 30 mg|Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
11289751|NCT02925117|OG000|Outcome|Placebo / Placebo|Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289752|NCT02925117|OG001|Outcome|Placebo / Upadacitinib 30 mg|Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
11289753|NCT02925117|OG002|Outcome|Upadacitinib 7.5 mg / Placebo|Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289754|NCT02925117|OG003|Outcome|Upadacitinib 7.5 mg / Upadacitinib 7.5 mg|Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
11289755|NCT02925117|OG004|Outcome|Upadacitinib 15 mg / Placebo|Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289756|NCT02925117|OG005|Outcome|Upadacitinib 15 mg / Upadacitinib 15 mg|Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
11289757|NCT02925117|OG006|Outcome|Upadacitinib 30 mg / Placebo|Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
11289758|NCT02925117|OG007|Outcome|Upadacitinib 30 mg / Upadacitinib 30 mg|Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
11289759|NCT02925117|EG000|Reported Event|Period 1: Placebo|Participants received placebo once daily (QD) for 16 weeks in Period 1.
11289760|NCT02925117|EG001|Reported Event|Period 1: Upadacitinib 7.5 mg|Participants received upadacitinib 7.5 mg once daily for 16 weeks in Period 1
11289761|NCT02925117|EG002|Reported Event|Period 1: Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 16 weeks in Period 1.
11289762|NCT02925117|EG003|Reported Event|Period 1: Upadacitinib 30 mg|Participants received upadacitinib 30 mg once daily for 16 weeks in Period 1.
11289763|NCT02925117|EG004|Reported Event|Period 1+2: Upadacitinib 7.5 mg|Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 7.5 mg in Period 2 continued to receive upadacitinib 7.5 mg for 72 weeks in Period 2 or until rescue.
11289764|NCT02925117|EG005|Reported Event|Period 1+2: Upadacitinib 15 mg|Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 15 mg in Period 2 continued to receive upadacitinib 15 mg for 72 weeks in Period 2 or until rescue.
11289765|NCT02925117|EG006|Reported Event|Period 1+2: Upadacitinib 30 mg|"Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 16 weeks in Period 1. Participants re-randomized to upadacitinib 30 mg in Period 2 continued to receive upadacitinib 30 mg for 72 weeks in Period 2.~Participants originally randomized to placebo and re-randomized to upadacitinib 30 mg at Week 16 received upadacitinib 30 mg from Week 16 to Week 88.~Participants re-randomized to placebo, upadacitinib 7.5 mg or 15 mg at Week 16 who were rescued starting at Week 20 or later received upadacitinib 30 mg until Week 88."
11289766|NCT02925117|EG007|Reported Event|Period 1+2: Placebo|"Participants originally randomized to placebo received placebo once daily for 16 weeks in Period 1.~Participants re-randomized to placebo in Period 2 continued to receive placebo for 72 weeks in Period 2 or until rescue."
11289767|NCT02925143|BG000|Baseline|E-learning Course|E-learning course in neuromuscular monitoring: An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
11289768|NCT02925143|FG000|Participant Flow|E-learning Course|E-learning course in neuromuscular monitoring: An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
11289769|NCT02925143|OG000|Outcome|E-learning Course|E-learning course in neuromuscular monitoring: An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
11289770|NCT02925143|EG000|Reported Event|E-learning Course|E-learning course in neuromuscular monitoring: An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
11289771|NCT02925312|BG000|Baseline|Intervention|"Patients receive the full diabetes pathway intervention~Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication"
11289772|NCT02925312|BG001|Baseline|Matched Controls|patients receive standard of care
11289773|NCT02925312|BG002|Baseline|Total|Total of all reporting groups
11289774|NCT02925312|FG000|Participant Flow|Intervention|"Patients receive the full diabetes pathway intervention~Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication"
11289775|NCT02925312|FG001|Participant Flow|Matched Controls|patients receive standard of care
11289776|NCT02925312|OG000|Outcome|Intervention|"Patients receive the full diabetes pathway intervention~Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication"
11289777|NCT02925312|OG001|Outcome|Matched Controls|patients receive standard of care
11289778|NCT02925312|EG000|Reported Event|Intervention|"Patients receive the full diabetes pathway intervention~Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication"
11289779|NCT02925312|EG001|Reported Event|Matched Controls|patients receive standard of care
11289780|NCT02925403|BG000|Baseline|Group 1|"10μg R21/Matrix-M1 on days 0, 28, and 56.~R21/Matrix-M1"
11289781|NCT02925403|BG001|Baseline|Group 2|"Saline injection on days 0, 28, and 56.~Saline"
11289782|NCT02925403|BG002|Baseline|Total|Total of all reporting groups
11289783|NCT02925403|FG000|Participant Flow|Group 1|"10μg R21/Matrix-M1 on days 0, 28, and 56.~R21/Matrix-M1"
11289784|NCT02925403|FG001|Participant Flow|Group 2|"Saline injection on days 0, 28, and 56.~Saline"
11289785|NCT02925403|OG000|Outcome|Group 1|"10μg R21/Matrix-M1 on days 0, 28, and 56.~R21/Matrix-M1"
11289786|NCT02925403|OG001|Outcome|Group 2|"Saline injection on days 0, 28, and 56.~Saline"
11289787|NCT02925403|EG000|Reported Event|Group 1|"10μg R21/Matrix-M1 on days 0, 28, and 56.~R21/Matrix-M1"
11289788|NCT02925403|EG001|Reported Event|Group 2|"Saline injection on days 0, 28, and 56.~Saline"
11289789|NCT02925455|BG000|Baseline|Stimulation + Video Games|"Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement.~Contralaterally-controlled functional electrical stimulation: Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289790|NCT02925455|BG001|Baseline|Video Games (no Stimulation)|"Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289791|NCT02925455|BG002|Baseline|Total|Total of all reporting groups
11289792|NCT02925455|FG000|Participant Flow|Stimulation + Video Games|"Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement.~Contralaterally-controlled functional electrical stimulation: Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289793|NCT02925455|FG001|Participant Flow|Video Games (no Stimulation)|"Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289794|NCT02925455|OG000|Outcome|Stimulation + Video Games|"Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement.~Contralaterally-controlled functional electrical stimulation: Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289795|NCT02925455|OG001|Outcome|Video Games (no Stimulation)|"Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289796|NCT02925455|EG000|Reported Event|Stimulation + Video Games|"Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement.~Contralaterally-controlled functional electrical stimulation: Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289797|NCT02925455|EG001|Reported Event|Video Games (no Stimulation)|"Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening.~Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements."
11289798|NCT02925494|BG000|Baseline|Placebo->Elagolix|Placebo in pivotal study and elagolix 300 mg BID in extension study.
11289799|NCT02925494|BG001|Baseline|Placebo->Elagolix + E2/NETA|Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289800|NCT02925494|BG002|Baseline|Elagolix->Elagolix|Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.
11289801|NCT02925494|BG003|Baseline|Elagolix + E2/NETA->Elagolix + E2/NETA|Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289802|NCT02925494|BG004|Baseline|Total|Total of all reporting groups
11289803|NCT02925494|FG000|Participant Flow|Placebo->Elagolix|Placebo in pivotal study and elagolix 300 mg twice daily (BID) in extension study.
11289804|NCT02925494|FG001|Participant Flow|Placebo->Elagolix + E2/NETA|Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) in extension study.
11289805|NCT02925494|FG002|Participant Flow|Elagolix->Elagolix|Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.
11289806|NCT02925494|FG003|Participant Flow|Elagolix + E2/NETA->Elagolix + E2/NETA|Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289807|NCT02925494|OG000|Outcome|Placebo->Elagolix|Placebo in pivotal study and elagolix 300 mg BID in extension study.
11289808|NCT02925494|OG001|Outcome|Placebo->Elagolix + E2/NETA|Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289809|NCT02925494|OG002|Outcome|Elagolix->Elagolix|Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.
11289810|NCT02925494|OG003|Outcome|Elagolix + E2/NETA->Elagolix + E2/NETA|Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289811|NCT02925494|OG003|Outcome|Elagolix->Elagolix + E2/NETA|Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289812|NCT02925494|EG000|Reported Event|Placebo->Elagolix|Placebo in pivotal study and elagolix 300 mg BID in extension study.
11289813|NCT02925494|EG001|Reported Event|Placebo->Elagolix + E2/NETA|Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289814|NCT02925494|EG002|Reported Event|Elagolix->Elagolix|Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.
11289815|NCT02925494|EG003|Reported Event|Elagolix + E2/NETA->Elagolix + E2/NETA|Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
11289816|NCT02925611|BG000|Baseline|Isoflurane|"Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.~Isoflurane"
11289817|NCT02925611|BG001|Baseline|Desflurane|"Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.~Desflurane"
11289818|NCT02925611|BG002|Baseline|Total|Total of all reporting groups
11289819|NCT02925611|FG000|Participant Flow|Isoflurane|"Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.~Isoflurane"
11289820|NCT02925611|FG001|Participant Flow|Desflurane|"Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.~Desflurane"
11289821|NCT02925611|OG000|Outcome|Isoflurane|"Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.~Isoflurane"
11289822|NCT02925611|OG001|Outcome|Desflurane|"Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.~Desflurane"
11289823|NCT02925611|EG000|Reported Event|Isoflurane|"Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.~Isoflurane"
11289824|NCT02925611|EG001|Reported Event|Desflurane|"Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.~Desflurane"
11289825|NCT02925741|BG000|Baseline|Silk-like Linen|Patients cared for on silk-like linen.
11289826|NCT02925741|BG001|Baseline|Standard Cotton Linen|Patients cared for on standard cotton linen
11289827|NCT02925741|BG002|Baseline|Total|Total of all reporting groups
11289828|NCT02925741|FG000|Participant Flow|Silk-like Linen|Patients being cared for on silk-like linens
11289829|NCT02925741|FG001|Participant Flow|Standard Cotton Linen|Patients being cared for on standard cotton linens
11289830|NCT02925741|OG000|Outcome|Silk-Like Linen|Patients in the experimental arm will be cared for on silk-like bed linens.
11289831|NCT02925741|OG001|Outcome|Standard Cotton Linen|Patients in the control arm will be cared for on standard cotton linen.
11289832|NCT02925741|OG000|Outcome|Silk-Like Linen|Patients in the experimental group will be cared for on silk-like linen.
11289833|NCT02925741|OG001|Outcome|Standard Cotton Linen|Patients in the control group will be cared for on standard cotton linen.
11289834|NCT02925741|OG001|Outcome|Standard Cotton Linen|Patients in the control group were cared for on standard cotton linen.
11289835|NCT02925741|EG000|Reported Event|Silk-like Linens|"This study will use a traditional parallel randomization design with patients in five medical intensive care units.~Patients were assigned to groups based on bed availability by personnel who were blinded to linens used on those units. Each unit used the linens assigned by the randomization procedure for six months followed by a fourteen day washout period. Patient participation was based on the unit to which they were assigned."
11289836|NCT02925741|EG001|Reported Event|Standard Cotton Linens|"This study will use a traditional parallel randomization design with patients in five medical intensive care units.~Patients were assigned to groups based on bed availability by personnel who were blinded to linens used on those units. Each unit used the linens assigned by the randomization procedure for six months followed by a fourteen day washout period. Patient participation was based on the unit to which they were assigned."
11289837|NCT02925858|BG000|Baseline|Ketamine|Bolus 0.5mg/kg, Infusion 0.5mg/kg/hr
11289838|NCT02925858|BG001|Baseline|Placebo|Normal Saline 0.025cc/kg bolus, 0.025cc/kg/hr
11289839|NCT02925858|BG002|Baseline|Total|Total of all reporting groups
11289840|NCT02925858|FG000|Participant Flow|Intervention|"Intraoperative infusion of ketamine~Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)"
11289841|NCT02925858|FG001|Participant Flow|Control|"Control group receiving a saline infusion~Normal Saline Flush, 0.9% Injectable Solution_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight"
11289842|NCT02925858|OG000|Outcome|Ketamine|"Intraoperative infusion of ketamine~Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)"
11289843|NCT02925858|OG001|Outcome|Placebo|"Control group receiving a saline infusion~Normal Saline Flush, 0.9% Injectable Solution_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight"
11289844|NCT02925858|EG000|Reported Event|Ketamine|"Intraoperative infusion of ketamine~Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)"
11289845|NCT02925858|EG001|Reported Event|Placebo|"Control group receiving a saline infusion~Normal Saline Flush, 0.9% Injectable Solution_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight"
11289846|NCT02925923|BG000|Baseline|Ticagrelor|"crushed ticagrelor (180 mg); (n=50 patients)~Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests."
11289847|NCT02925923|BG001|Baseline|Eptifibatide Bolus+Clopidogrel|"Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)~Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.~Clopidogrel"
11289848|NCT02925923|BG002|Baseline|Total|Total of all reporting groups
11289849|NCT02925923|FG000|Participant Flow|Ticagrelor|"crushed ticagrelor (180 mg); (n=50 patients)~Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests."
11289850|NCT02925923|FG001|Participant Flow|Eptifibatide Bolus+Clopidogrel|"Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)~Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.~Clopidogrel"
11289851|NCT02925923|OG000|Outcome|Ticagrelor|"crushed ticagrelor (180 mg); (n=50 patients)~Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests."
11289852|NCT02925923|OG001|Outcome|Eptifibatide Bolus+Clopidogrel|"Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)~Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.~Clopidogrel"
11289853|NCT02925923|EG000|Reported Event|Ticagrelor|"crushed ticagrelor (180 mg); (n=50 patients)~Ticagrelor: After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests."
11289854|NCT02925923|EG001|Reported Event|Eptifibatide Bolus+Clopidogrel|"Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)~Eptifibatide: After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.~Clopidogrel"
11289855|NCT02926027|BG000|Baseline|Active Subjects|"Vascepa (4 gm/day), oral dose~Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid."
11289856|NCT02926027|BG001|Baseline|Placebo Subject|"oral dose of placebo~placebo: placebo"
11289857|NCT02926027|BG002|Baseline|Total|Total of all reporting groups
11289858|NCT02926027|FG000|Participant Flow|Active Subjects|"Vascepa (4 gm/day), oral dose~Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid."
11289859|NCT02926027|FG001|Participant Flow|Placebo Subject|"oral dose of placebo~placebo: placebo"
11289860|NCT02926027|OG000|Outcome|Active Subjects|"Vascepa (4 gm/day), oral dose~Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid."
11289861|NCT02926027|OG001|Outcome|Placebo Subject|"oral dose of placebo~placebo: placebo"
11289862|NCT02926027|EG000|Reported Event|Active Subjects|"Vascepa (4 gm/day), oral dose~Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid."
11289863|NCT02926027|EG001|Reported Event|Placebo Subject|"oral dose of placebo~placebo: placebo"
11289864|NCT02926209|BG000|Baseline|Training Cohort|The first 20 subjects in this study were in the training cohort which was not evaluated statistically for the objectives.
11289865|NCT02926209|FG000|Participant Flow|Aer-O-Scope First|"Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope"
11289866|NCT02926209|FG001|Participant Flow|Conventional Colonoscope First|"Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope"
11336294|NCT03565068|OG010|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11289867|NCT02926209|OG000|Outcome|Aer-O-Scope First|"Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope"
11289868|NCT02926209|OG001|Outcome|Conventional Colonoscope First|"Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope"
11289869|NCT02926209|EG000|Reported Event|Training Cohort|The first 10 patients for each physician were considered the physician training cohort. These patients were not analysed with the final study cohort which included the Aer-O-Scope First and Conventional Colonscope First Arms. No adverse events, immediate or delayed occurred during the course of this study, as such, the arms were combined for reporting
11289870|NCT02926209|EG001|Reported Event|Aer-O-Scope First|"Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope No adverse events, immediate or delayed occurred during the course of this study, as such, the arms were combined for reporting"
11289871|NCT02926209|EG002|Reported Event|Conventional Colonoscope First|"Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope~Aer-O-Scope (Colonoscopy): Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.~Colonoscopy (Conventional Colonoscope): Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope No adverse events, immediate or delayed occurred during the course of this study, as such, the arms were combined for reporting"
11289872|NCT02926573|BG000|Baseline|Gabapentin|Gabapentin liquid by mouth or per Tube 300mg twice a day
11289873|NCT02926573|BG001|Baseline|Placebo|Placebo liquid by mouth or Per Tube twice a day
11289874|NCT02926573|BG002|Baseline|Total|Total of all reporting groups
11289875|NCT02926573|FG000|Participant Flow|Gabapentin|Gabapentin liquid by mouth or per Tube 300mg twice a day
11289876|NCT02926573|FG001|Participant Flow|Placebo|Placebo liquid by mouth or Per Tube twice a day
11289877|NCT02926573|OG000|Outcome|Gabapentin|Gabapentin liquid by mouth or per Tube 300mg twice a day
11289878|NCT02926573|OG001|Outcome|Placebo|Placebo liquid by mouth or Per Tube twice a day
11289879|NCT02926573|EG000|Reported Event|Gabapentin|Gabapentin liquid by mouth or per Tube 300mg twice a day
11289880|NCT02926573|EG001|Reported Event|Placebo|Placebo liquid by mouth or Per Tube twice a day
11289881|NCT02926677|BG000|Baseline|Cue-Centered Treatment (CCT)|"Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11332488|NCT03496428|FG000|Participant Flow|Dental Implant Impression Techniques|"Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.~An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined~Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques"
11332489|NCT03496428|OG000|Outcome|Dental Implant Impression Techniques|"Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.~An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined~Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques"
11336295|NCT03565068|OG011|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11289882|NCT02926677|BG001|Baseline|Trauma-Focused CBT (TF-CBT)|"Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289883|NCT02926677|BG002|Baseline|Treatment as Usual (TAU)|"TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289884|NCT02926677|BG003|Baseline|Total|Total of all reporting groups
11289885|NCT02926677|FG000|Participant Flow|Cue-Centered Treatment (CCT)|"Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289886|NCT02926677|FG001|Participant Flow|Trauma-Focused CBT (TF-CBT)|"Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289887|NCT02926677|FG002|Participant Flow|Treatment as Usual (TAU)|"TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289888|NCT02926677|OG000|Outcome|Cue-Centered Treatment (CCT)|"Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289889|NCT02926677|OG001|Outcome|Trauma-Focused CBT (TF-CBT)|"Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
10970853|NCT00912509|BG001|Baseline|45 Minute Light Duration|"45 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970854|NCT00912509|BG002|Baseline|Total|Total of all reporting groups
11289890|NCT02926677|OG002|Outcome|Treatment as Usual (TAU)|"TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289891|NCT02926677|OG000|Outcome|Cue-Centered Therapy (CCT)|"Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289892|NCT02926677|EG000|Reported Event|Cue-Centered Treatment (CCT)|"Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289893|NCT02926677|EG001|Reported Event|Trauma-Focused CBT (TF-CBT)|"Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289894|NCT02926677|EG002|Reported Event|Treatment as Usual (TAU)|"TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)~Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions~NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity."
11289895|NCT02926937|BG000|Baseline|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289896|NCT02926937|BG001|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289897|NCT02926937|BG002|Baseline|Sotagliflozin 200 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289898|NCT02926937|BG003|Baseline|Total|Total of all reporting groups
11289899|NCT02926937|FG000|Participant Flow|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289900|NCT02926937|FG001|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289901|NCT02926937|FG002|Participant Flow|Sotagliflozin 200 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
10970855|NCT00912509|FG000|Participant Flow|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970856|NCT00912509|FG001|Participant Flow|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970857|NCT00912509|OG000|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970858|NCT00912509|OG001|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
11289902|NCT02926937|OG000|Outcome|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289903|NCT02926937|OG001|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289904|NCT02926937|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks
11289905|NCT02926937|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289906|NCT02926937|EG000|Reported Event|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289907|NCT02926937|EG001|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289908|NCT02926937|EG002|Reported Event|Sotagliflozin 200 mg|Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
11289909|NCT02926950|BG000|Baseline|Placebo + Metformin|Following a 2-week run-in period, matching placebo was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289910|NCT02926950|BG001|Baseline|Sotagliflozin 400 mg + Metformin|Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289911|NCT02926950|BG002|Baseline|Total|Total of all reporting groups
11289912|NCT02926950|FG000|Participant Flow|Placebo + Metformin|Following a 2-week run-in period, matching placebo was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289913|NCT02926950|FG001|Participant Flow|Sotagliflozin 400 mg + Metformin|Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289914|NCT02926950|OG000|Outcome|Placebo + Metformin|Following a 2-week run-in period, matching placebo was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289915|NCT02926950|OG001|Outcome|Sotagliflozin 400 mg + Metformin|Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, QD, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289916|NCT02926950|OG001|Outcome|Sotagliflozin 400 mg + Metformin|Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289917|NCT02926950|EG000|Reported Event|Placebo + Metformin|Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289918|NCT02926950|EG001|Reported Event|Sotagliflozin 400 mg + Metformin|Following a 2-week run-in period, Sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus Metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
11289919|NCT02927080|BG000|Baseline|ACE-083 (Part 1, Cohort 1a) Tibialis Anterior (TA) 150mg|ACE-083 150 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289920|NCT02927080|BG001|Baseline|ACE-083 (Part 1, Cohort 2a) Tibialis Anterior (TA) 200mg|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289921|NCT02927080|BG002|Baseline|ACE-083 (Part 1, Cohort 3a) Tibialis Anterior (TA) 200mg|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289922|NCT02927080|BG003|Baseline|ACE-083 (Part 1, Cohort 1b) Biceps Brachii (BB) 150 mg|ACE-083 150 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289923|NCT02927080|BG004|Baseline|ACE-083 (Part 1, Cohort 2b) Biceps Brachii (BB) 200 mg|ACE-083 200 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289924|NCT02927080|BG005|Baseline|ACE-083 (Part 1, Cohort 3b) Biceps Brachii (BB) 240 mg|ACE-083 240 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289925|NCT02927080|BG006|Baseline|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo- TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289926|NCT02927080|BG007|Baseline|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein."
11289927|NCT02927080|BG008|Baseline|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo- BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289928|NCT02927080|BG009|Baseline|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289929|NCT02927080|BG010|Baseline|Total|Total of all reporting groups
11289930|NCT02927080|FG000|Participant Flow|ACE-083 (Part 1, Cohort 1a) Tibialis Anterior (TA) Unilateral|ACE-083 150 mg Tibialis Anterior (TA) unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289931|NCT02927080|FG001|Participant Flow|ACE-083 (Part 1, Cohort 2a) Tibialis Anterior (TA) Unilateral|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289932|NCT02927080|FG002|Participant Flow|ACE-083 (Part 1, Cohort 3a) Tibialis Anterior (TA) Bilateral|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289933|NCT02927080|FG003|Participant Flow|ACE-083 (Part 1, Cohort 1b) Biceps Brachii (BB) Unilateral|ACE-083 150 mg Biceps Brachii (BB) unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289934|NCT02927080|FG004|Participant Flow|ACE-083 (Part 1, Cohort 2b) Biceps Brachii (BB) Unilateral|ACE-083 200 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289935|NCT02927080|FG005|Participant Flow|ACE-083 (Part 1, Cohort 3b) Biceps Brachii (BB) Unilateral|ACE-083 240 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289936|NCT02927080|FG006|Participant Flow|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|Double-Blind, Placebo-Controlled Placebo TA bilaterally, once every 3 weeks for up to 9 doses. Drug: Placebo Normal saline
11289937|NCT02927080|FG007|Participant Flow|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289938|NCT02927080|FG008|Participant Flow|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo-BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289939|NCT02927080|FG009|Participant Flow|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289940|NCT02927080|OG000|Outcome|ACE-083 (Part 1, Cohort 1a) Tibialis Anterior (TA) 150 mg|ACE-083 150 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289941|NCT02927080|OG001|Outcome|ACE-083 (Part 1, Cohort 2a) Tibialis Anterior (TA) 200 mg|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein.
11289942|NCT02927080|OG002|Outcome|ACE-083 (Part 1, Cohort 3a) Tibialis Anterior (TA) 200 mg|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289943|NCT02927080|OG003|Outcome|ACE-083 (Part 1, Cohort 1b) Biceps Brachii (BB) 150 mg|ACE-083 150 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289944|NCT02927080|OG004|Outcome|ACE-083 (Part 1, Cohort 2b) Biceps Brachii (BB) 200 mg|ACE-083 200 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289945|NCT02927080|OG005|Outcome|ACE-083 (Part 1, Cohort 3b) Biceps Brachii (BB) 240 mg|ACE-083 240 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289946|NCT02927080|OG006|Outcome|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo-TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289947|NCT02927080|OG007|Outcome|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289948|NCT02927080|OG008|Outcome|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo- BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289949|NCT02927080|OG009|Outcome|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
10970859|NCT00912509|OG000|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970860|NCT00912509|EG000|Reported Event|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
11289950|NCT02927080|OG001|Outcome|ACE-083 (Part 1, Cohort 2a) Tibialis Anterior (TA) 200 mg|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289951|NCT02927080|OG006|Outcome|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo- TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289952|NCT02927080|OG003|Outcome|ACE-083 (Part 1, Cohort 1b ) Biceps Brachii (BB) 150 mg|ACE-083 150 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289953|NCT02927080|OG000|Outcome|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo- TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289954|NCT02927080|OG001|Outcome|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein."
11289955|NCT02927080|OG002|Outcome|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo- BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289956|NCT02927080|OG003|Outcome|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289957|NCT02927080|OG001|Outcome|ACE-083 (Part 1, Cohort 2a) Tibialis Anterior (TA) 200mg|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289958|NCT02927080|OG000|Outcome|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo-TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289959|NCT02927080|OG001|Outcome|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289960|NCT02927080|OG002|Outcome|Placebo (Part 2, DB-PC) Bicpes Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo- BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289961|NCT02927080|OG000|Outcome|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo-BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289962|NCT02927080|OG001|Outcome|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289963|NCT02927080|OG000|Outcome|Placebo (Part 2, DB-PC) Biceps Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo- BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289964|NCT02927080|OG000|Outcome|ACE-083 (Part 1, Cohort 3a) Tibialis Anterior (TA) Bilateral)|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289965|NCT02927080|OG000|Outcome|ACE-083 (Part 1, Cohort 3a) Tibialis Anterior (TA) Bilateral|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289966|NCT02927080|OG000|Outcome|ACE-083 (Part 1, Cohort 2b) Biceps Brachii (BB) Unilateral|ACE-083 200 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289967|NCT02927080|OG000|Outcome|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg Day 2, 24 Hours Post-dose|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289968|NCT02927080|OG000|Outcome|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289969|NCT02927080|OG000|Outcome|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg Day 1, 2 Hours Post-dose|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289970|NCT02927080|OG000|Outcome|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289971|NCT02927080|EG000|Reported Event|ACE-083 (Part 1, Cohort 1a ) Tibialis Anterior (TA) 150mg|ACE-083 150 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289972|NCT02927080|EG001|Reported Event|ACE-083 (Part 1, Cohort 2a ) Tibialis Anterior (TA) 200mg|ACE-083 200 mg TA unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289973|NCT02927080|EG002|Reported Event|ACE-083 (Part 1, Cohort 3a ) Tibialis Anterior (TA) 200mg|ACE-083 200 mg TA bilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289974|NCT02927080|EG003|Reported Event|ACE-083 (Part 1, Cohort 1b ) Biceps Brachii (BB) 150 mg|ACE-083 150 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289975|NCT02927080|EG004|Reported Event|ACE-083 (Part 1, Cohort 2b ) Biceps Brachii (BB) 200 mg|ACE-083 200 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein
11289976|NCT02927080|EG005|Reported Event|ACE-083 (Part 1, Cohort 3b ) Biceps Brachii (BB) 240 mg|ACE-083 240 mg BB unilaterally, once every 3 weeks for up to 5 doses. Drug: ACE-083 Recombinant fusion protein.
11289977|NCT02927080|EG006|Reported Event|Placebo (Part 2, DB-PC) Tibialis Anterior (TA)|"Double-Blind, Placebo-Controlled Placebo TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289978|NCT02927080|EG007|Reported Event|ACE-083 (Part 2, DB-PC) Tibialis Anterior (TA) 240 mg|"Double-Blind, Placebo-Controlled ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289979|NCT02927080|EG008|Reported Event|Placebo (Part 2, DB-PC) Bicpes Brachii (BB)|"Double-Blind, Placebo-Controlled Placebo BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: Placebo Normal saline"
11289980|NCT02927080|EG009|Reported Event|ACE-083 (Part 2, DB-PC) Biceps Brachii (BB) 240 mg|"ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 9 doses.~Drug: ACE-083 Recombinant fusion protein"
11289981|NCT02927080|EG010|Reported Event|ACE-083 (Part 2, Open-label) Tibialis Anterior (TA) 240 mg|"ACE-083 240 mg TA bilaterally, once every 3 weeks for up to 8 doses.~Drug: ACE-083 Recombinant fusion protein"
11289982|NCT02927080|EG011|Reported Event|ACE-083 (Part 2, Open-label) Biceps Brachii (BB) 240 mg|"ACE-083 240 mg BB bilaterally, once every 3 weeks for up to 8 doses.~Drug: ACE-083 Recombinant fusion protein"
11289983|NCT02927171|BG000|Baseline|Usual Care|Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
11289984|NCT02927171|BG001|Baseline|I-STRONGER|"IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.~IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities."
11289985|NCT02927171|BG002|Baseline|Total|Total of all reporting groups
10970861|NCT00912509|EG001|Reported Event|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
10970862|NCT00912743|BG000|Baseline|MSI-H|MSI-H group receiving olaparib 400mg BID
10970863|NCT00912743|BG001|Baseline|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
10970864|NCT00912743|BG002|Baseline|Total|Total of all reporting groups
10970865|NCT00912743|FG000|Participant Flow|MSI-H|MSI-H group receiving olaparib 400mg BID
10970866|NCT00912743|FG001|Participant Flow|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
10970867|NCT00912743|OG000|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
10970868|NCT00912743|OG001|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
10970869|NCT00912743|EG000|Reported Event|MSI-H|MSI-H group receiving olaparib 400mg BID
10970870|NCT00912743|EG001|Reported Event|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
10970871|NCT00912782|BG000|Baseline|Placebo|Placebo one time per week for 3 weeks
10970872|NCT00912782|BG001|Baseline|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
10970873|NCT00912782|BG002|Baseline|Total|Total of all reporting groups
10970874|NCT00912782|FG000|Participant Flow|Placebo|Placebo one time per week for 3 weeks
10970875|NCT00912782|FG001|Participant Flow|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
10970876|NCT00912782|OG000|Outcome|Placebo|Placebo one time per week for 3 weeks
10970877|NCT00912782|OG001|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
10970878|NCT00912782|EG000|Reported Event|Placebo|Placebo one time per week for 3 weeks
10970879|NCT00912782|EG001|Reported Event|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
10970880|NCT00912795|BG000|Baseline|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
10970881|NCT00912795|BG001|Baseline|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
10970882|NCT00912795|BG002|Baseline|Total|Total of all reporting groups
10970883|NCT00912795|FG000|Participant Flow|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
10970884|NCT00912795|FG001|Participant Flow|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
10970885|NCT00912795|OG000|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
10970886|NCT00912795|OG001|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
10970887|NCT00912795|EG000|Reported Event|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
11289986|NCT02927171|FG000|Participant Flow|Usual Care|Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
11289987|NCT02927171|FG001|Participant Flow|I-STRONGER|"IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.~IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities."
11289988|NCT02927171|OG000|Outcome|Usual Care|Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
11289989|NCT02927171|OG001|Outcome|I-STRONGER|"IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.~IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities."
11289990|NCT02927171|EG000|Reported Event|Usual Care|Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
11289991|NCT02927171|EG001|Reported Event|I-STRONGER|"IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.~IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities."
11289992|NCT02927223|BG000|Baseline|Treadmill Then Treadmill With Atropine|"Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine~Atropine~Exercise treadmill test"
11289993|NCT02927223|FG000|Participant Flow|Treadmill Then Treadmill With Atropine|"Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine~Atropine~Exercise treadmill test"
11289994|NCT02927223|OG000|Outcome|Treadmill|"Patients will undergo treadmill exercise at baseline,~Exercise treadmill test"
11289995|NCT02927223|OG001|Outcome|Treadmill With Atropine|"Patients will undergo treadmill exercise after IV atropine~Atropine~Exercise treadmill test"
11289996|NCT02927223|EG000|Reported Event|Treadmill|"Patients will undergo treadmill exercise at baseline,~Exercise treadmill test"
11289997|NCT02927223|EG001|Reported Event|Treadmill With Atropine|"Patients will undergo treadmill exercise after IV atropine~Atropine~Exercise treadmill test"
11289998|NCT02927301|BG000|Baseline|Atezolizumab|Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab.
11289999|NCT02927301|FG000|Participant Flow|Atezolizumab|Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab.
11290000|NCT02927301|OG000|Outcome|Atezolizumab|Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab.
11290001|NCT02927301|EG000|Reported Event|Atezolizumab|Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab.
11290002|NCT02927327|BG000|Baseline|PET/MR ZTE MRAC|"PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.~Zero Echo Time (ZTE) scan for head attenuation~Zero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.~PET/MR ZTE MRAC"
11290003|NCT02927327|BG001|Baseline|PET/MR Q Static (Q. MRAC)|"Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.~PET/MR Q Static (Q. MRAC)~Q.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.~PET/MR Q Static (Q. MRAC)"
11290004|NCT02927327|BG002|Baseline|Total|Total of all reporting groups
11290005|NCT02927327|FG000|Participant Flow|PET/MR ZTE MRAC|"PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.~Zero Echo Time (ZTE) scan for head attenuation~Zero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.~PET/MR ZTE MRAC"
11290006|NCT02927327|FG001|Participant Flow|PET/MR Q Static (Q. MRAC)|"Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.~PET/MR Q Static (Q. MRAC)~Q.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.~PET/MR Q Static (Q. MRAC)"
11290007|NCT02927327|OG000|Outcome|PET/MR ZTE MRAC|"PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.~Zero Echo Time (ZTE) scan for head attenuation~Zero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.~PET/MR ZTE MRAC"
11290008|NCT02927327|OG001|Outcome|PET/MR Q Static (Q. MRAC)|"Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.~PET/MR Q Static (Q. MRAC)~Q.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.~PET/MR Q Static (Q. MRAC)"
11290009|NCT02927327|EG000|Reported Event|PET/MR ZTE MRAC|"PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.~Zero Echo Time (ZTE) scan for head attenuation~Zero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.~PET/MR ZTE MRAC"
11290010|NCT02927327|EG001|Reported Event|PET/MR Q Static (Q. MRAC)|"Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.~PET/MR Q Static (Q. MRAC)~Q.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.~PET/MR Q Static (Q. MRAC)"
11290011|NCT02927366|BG000|Baseline|QCC374|Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14).
11290012|NCT02927366|BG001|Baseline|Placebo|Adult patients with pulmonary arterial hypertension (PAH) on placebo matching to QCC374 doses (0.03 mg BID (Day 1-3), 0.06 mg BID (Day 4) and 0.12 mg BID (Day 7-14)).
11290013|NCT02927366|BG002|Baseline|Total|Total of all reporting groups
11290014|NCT02927366|FG000|Participant Flow|QCC374|Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14).
11290015|NCT02927366|FG001|Participant Flow|Placebo|Adult patients with pulmonary arterial hypertension (PAH) on placebo matching to QCC374 doses (0.03 mg BID (Day 1-3), 0.06 mg BID (Day 4) and 0.12 mg BID (Day 7-14)).
11290016|NCT02927366|OG000|Outcome|QCC374|Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14).
11290017|NCT02927366|OG001|Outcome|Placebo|Adult patients with pulmonary arterial hypertension (PAH) on placebo matching to QCC374 doses (0.03 mg BID (Day 1-3), 0.06 mg BID (Day 4) and 0.12 mg BID (Day 7-14)).
11290018|NCT02927366|EG000|Reported Event|QCC374|Adult patients with pulmonary arterial hypertension (PAH) on QCC374. All patients were initiated at 0.03 mg BID (Day 1-3), and were up-titrated to next higher dose 0.06 mg BID (Day 4) and increased to 0.12 mg BID (Day 7-14).
11290019|NCT02927366|EG001|Reported Event|Placebo|Adult patients with pulmonary arterial hypertension (PAH) on placebo matching to QCC374 doses (0.03 mg BID (Day 1-3), 0.06 mg BID (Day 4) and 0.12 mg BID (Day 7-14)).
11290020|NCT02927431|BG000|Baseline|Placebo + OSV|Participants received matching placebo given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290021|NCT02927431|BG001|Baseline|DNX 15 mg + OSV|Participants received DNX 15 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290022|NCT02927431|BG002|Baseline|DNX 50 mg + OSV|Participants received DNX 50 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290023|NCT02927431|BG003|Baseline|Total|Total of all reporting groups
11290024|NCT02927431|FG000|Participant Flow|Placebo + OSV|Participants received matching placebo given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 milligram (mg) twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290025|NCT02927431|FG001|Participant Flow|DNX 15 mg + OSV|Participants received DNX 15 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290026|NCT02927431|FG002|Participant Flow|DNX 50 mg + OSV|Participants received DNX 50 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290027|NCT02927431|OG000|Outcome|Placebo + OSV|Participants received matching placebo given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290028|NCT02927431|OG001|Outcome|DNX 15 mg + OSV|Participants received DNX 15 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290029|NCT02927431|OG002|Outcome|DNX 50 mg + OSV|Participants received DNX 50 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290030|NCT02927431|OG000|Outcome|DNX 15 mg + OSV|Participants received DNX 15 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290031|NCT02927431|OG001|Outcome|DNX 50 mg + OSV|Participants received DNX 50 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290032|NCT02927431|EG000|Reported Event|Placebo + OSV|Participants received matching placebo given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290033|NCT02927431|EG001|Reported Event|DNX 15 mg + OSV|Participants received DNX 15 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290034|NCT02927431|EG002|Reported Event|DNX 50 mg + OSV|Participants received DNX 50 mg given as a 1 hour infusion twice daily for up to 5 days. Infusion was administered at a constant rate over approximately 1 hour +- 10 minutes and approximately 12 hours apart +- 1 hour. All participants also received open-label oral OSV 75 mg twice daily given as standard of care. The investigator could elect to continue treatment with OSV after 5 days of study treatment.
11290035|NCT02927457|BG000|Baseline|Group A-Participants With Photoprovocation Lesions|Participants who developed lesions following 3 consecutive days of photoprovocation were planned to be administered topical white to off-white GSK2646264 (1 percent [%] weight by weight [w/w]) to 1 lesion and placebo to 1 lesion (at the same time), once daily for 28 consecutive days. Either 1% w/w GSK2646264 or placebo was planned also to be administered to an area of uninvolved skin for 28 days.
11290036|NCT02927457|BG001|Baseline|Group B- Participants With Natural Lesions|Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w) and placebo. The treatments were administered at the same time on different skin sites once daily for 28 days.
11290037|NCT02927457|BG002|Baseline|Total|Total of all reporting groups
11290038|NCT02927457|FG000|Participant Flow|Group A-Participants With Photoprovocation Lesions|Participants who developed lesions following 3 consecutive days of photoprovocation were planned to be administered topical white to off-white GSK2646264 (1 percent [%] weight by weight [w/w]) to 1 lesion and placebo to 1 lesion (at the same time), once daily for 28 consecutive days. Either 1% w/w GSK2646264 or placebo was planned also to be administered to an area of uninvolved skin for 28 days.
11290039|NCT02927457|FG001|Participant Flow|Group B-Participants With Natural Lesions|Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w) and placebo. The treatments were administered at the same time on different skin sites once daily for 28 days.
11290040|NCT02927457|OG000|Outcome|Group A-Participants With Photoprovocation Lesions|Participants who developed lesions following 3 consecutive days of photoprovocation were planned to be administered topical white to off-white GSK2646264 (1 percent [%] weight by weight [w/w]) to 1 lesion and placebo to 1 lesion (at the same time), once daily for 28 consecutive days. Either 1% w/w GSK2646264 or placebo was planned also to be administered to an area of uninvolved skin for 28 days.
11290041|NCT02927457|OG001|Outcome|Group B-Participants With Natural Lesions|Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w) and placebo. The treatments were administered at the same time on different skin sites once daily for 28 days.
11290042|NCT02927457|OG000|Outcome|Group A-Participants With Photoprovocation Lesions; Placebo|Participants who developed photoprovocation lesions following photoprovocation challenge were planned to be topically administered white to off-white aqueous cream of placebo. The treatments were planned to be administered at the same time on different skin sites once daily for 28 days.
11290043|NCT02927457|OG001|Outcome|Group A-Participants With Photoprovocation Lesions; GSK2646264|Participants who developed photoprovocation lesions following photoprovocation challenge were planned to be topically administered white to off-white aqueous cream of GSK2646264 (1% weight by weight, [w/w]). The treatments were planned to be administered at the same time on different skin sites once daily for 28 days.
11290044|NCT02927457|OG002|Outcome|Group B-Participants With Natural Lesions; Placebo|Participants with natural lesions were topically administered white to off-white aqueous cream of placebo. The treatments were administered at the same time on different skin sites once daily for 28 days.
11290045|NCT02927457|OG003|Outcome|Group B-Participants With Natural Lesions; GSK2646264|Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w). The treatments were administered at the same time on different skin sites once daily for 28 days.
11290046|NCT02927457|EG000|Reported Event|Group A-Participants With Photoprovocation Lesions|Participants who developed lesions following 3 consecutive days of photoprovocation were planned to be administered topical white to off-white GSK2646264 (1 percent [%] weight by weight [w/w]) to 1 lesion and placebo to 1 lesion (at the same time), once daily for 28 consecutive days. Either 1% w/w GSK2646264 or placebo was planned also to be administered to an area of uninvolved skin for 28 days.
11290047|NCT02927457|EG001|Reported Event|Group B-Participants With Natural Lesions|Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w) and placebo. The treatments were administered at the same time on different skin sites once daily for 28 days.
11290048|NCT02927639|BG000|Baseline|Intervention|"This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.~MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device."
11290049|NCT02927639|BG001|Baseline|Control|This group will receive the usual standard of care for 6 months.
11290050|NCT02927639|BG002|Baseline|Total|Total of all reporting groups
11290051|NCT02927639|FG000|Participant Flow|Intervention|"This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.~MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device."
11290052|NCT02927639|FG001|Participant Flow|Control|This group will receive the usual standard of care for 6 months.
11290053|NCT02927639|OG000|Outcome|Intervention|"This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.~MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device."
11290054|NCT02927639|OG001|Outcome|Control|This group will receive the usual standard of care for 6 months.
11290055|NCT02927639|EG000|Reported Event|Intervention|"This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.~MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device."
11290056|NCT02927639|EG001|Reported Event|Control|This group will receive the usual standard of care for 6 months.
11290057|NCT02927795|BG000|Baseline|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11290058|NCT02927795|FG000|Participant Flow|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11290059|NCT02927795|OG000|Outcome|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11290060|NCT02927795|EG000|Reported Event|Spiolto® Respimat®|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11290061|NCT02927834|BG000|Baseline|Antibiotic Only|"1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.~Augmentin: Antibiotic augmentin for 3 weeks"
11290062|NCT02927834|BG001|Baseline|Augmentin With 6 Day Steroid|"Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)~6 day Prednisone: 6 day prednisone burst~Augmentin: Antibiotic augmentin for 3 weeks"
11290063|NCT02927834|BG002|Baseline|Augmentin With 21 Day Steroid|"Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )~Augmentin: Antibiotic augmentin for 3 weeks~21 day Prednisone: 21 day prednisone burst"
11290064|NCT02927834|BG003|Baseline|Total|Total of all reporting groups
11290065|NCT02927834|FG000|Participant Flow|Antibiotic Only|"1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.~Augmentin: Antibiotic augmentin for 3 weeks"
11290066|NCT02927834|FG001|Participant Flow|Augmentin With 6 Day Steroid|"Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)~6 day Prednisone: 6 day prednisone burst~Augmentin: Antibiotic augmentin for 3 weeks"
11290067|NCT02927834|FG002|Participant Flow|Augmentin With 21 Day Steroid|"Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )~Augmentin: Antibiotic augmentin for 3 weeks~21 day Prednisone: 21 day prednisone burst"
11290068|NCT02927834|OG000|Outcome|Antibiotic Only|"1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.~Augmentin: Antibiotic augmentin for 3 weeks"
11290069|NCT02927834|OG001|Outcome|Augmentin With 6 Day Steroid|"Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)~6 day Prednisone: 6 day prednisone burst~Augmentin: Antibiotic augmentin for 3 weeks"
11290070|NCT02927834|OG002|Outcome|Augmentin With 21 Day Steroid|"Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )~Augmentin: Antibiotic augmentin for 3 weeks~21 day Prednisone: 21 day prednisone burst"
11290071|NCT02927834|EG000|Reported Event|Antibiotic Only|"1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.~Augmentin: Antibiotic augmentin for 3 weeks"
11290072|NCT02927834|EG001|Reported Event|Augmentin With 6 Day Steroid|"Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)~6 day Prednisone: 6 day prednisone burst~Augmentin: Antibiotic augmentin for 3 weeks"
11290073|NCT02927834|EG002|Reported Event|Augmentin With 21 Day Steroid|"Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )~Augmentin: Antibiotic augmentin for 3 weeks~21 day Prednisone: 21 day prednisone burst"
11290074|NCT02927873|BG000|Baseline|RSV LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290075|NCT02927873|BG001|Baseline|RSV MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290076|NCT02927873|BG002|Baseline|RSV HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290077|NCT02927873|BG003|Baseline|Placebo LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290078|NCT02927873|BG004|Baseline|Placebo MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290079|NCT02927873|BG005|Baseline|Placebo HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290080|NCT02927873|BG006|Baseline|Total|Total of all reporting groups
11290081|NCT02927873|FG000|Participant Flow|RSV LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290082|NCT02927873|FG001|Participant Flow|RSV MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290083|NCT02927873|FG002|Participant Flow|RSV HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290084|NCT02927873|FG003|Participant Flow|Placebo LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290085|NCT02927873|FG004|Participant Flow|Placebo MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290086|NCT02927873|FG005|Participant Flow|Placebo HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290087|NCT02927873|OG000|Outcome|RSV LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290088|NCT02927873|OG001|Outcome|RSV MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290089|NCT02927873|OG002|Outcome|RSV HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290090|NCT02927873|OG003|Outcome|Placebo LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290091|NCT02927873|OG004|Outcome|Placebo MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290092|NCT02927873|OG005|Outcome|Placebo HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290093|NCT02927873|EG000|Reported Event|RSV LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290094|NCT02927873|EG001|Reported Event|RSV MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290095|NCT02927873|EG002|Reported Event|RSV HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
11290096|NCT02927873|EG003|Reported Event|Placebo LD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290097|NCT02927873|EG004|Reported Event|Placebo MD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290098|NCT02927873|EG005|Reported Event|Placebo HD Group|RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
11290099|NCT02927925|BG000|Baseline|Daratumumab|Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
11290100|NCT02927925|FG000|Participant Flow|Daratumumab|Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
11290101|NCT02927925|OG000|Outcome|Daratumumab|Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
11290102|NCT02927925|EG000|Reported Event|Daratumumab|Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
11290103|NCT02928029|BG000|Baseline|Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone|Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290104|NCT02928029|BG001|Baseline|Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone|Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290105|NCT02928029|BG002|Baseline|Total|Total of all reporting groups
11290106|NCT02928029|FG000|Participant Flow|Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone|Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290107|NCT02928029|FG001|Participant Flow|Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone|Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290108|NCT02928029|OG000|Outcome|Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone|Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290109|NCT02928029|OG001|Outcome|Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone|Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
11290110|NCT02928029|EG000|Reported Event|Radium-223 33 kBq/kg + BOR/DEX|Subjects received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
11290111|NCT02928029|EG001|Reported Event|Radium-223 55 kBq/kg + BOR/DEX|Subjects received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223dichloride doses in combination with BOR and DEX
11290112|NCT02928055|BG000|Baseline|PNS (3 hr/Day)|The PNS (3 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (3 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290113|NCT02928055|BG001|Baseline|PNS (6 hr/Day)|The PNS (6 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290114|NCT02928055|BG002|Baseline|PNS (9 hr/Day)|The PNS (9 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (9 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290115|NCT02928055|BG003|Baseline|Total|Total of all reporting groups
11290116|NCT02928055|FG000|Participant Flow|PNS (3 hr/Day)|The PNS (3 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (3 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290117|NCT02928055|FG001|Participant Flow|PNS (6 hr/Day)|The PNS (6 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290118|NCT02928055|FG002|Participant Flow|PNS (9 hr/Day)|The PNS (9 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (9 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290119|NCT02928055|OG000|Outcome|PNS (3 hr/Day)|The PNS (3 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (3 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290120|NCT02928055|OG001|Outcome|PNS (6 hr/Day)|The PNS (6 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290121|NCT02928055|OG002|Outcome|PNS (9 hr/Day)|The PNS (9 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (9 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290122|NCT02928055|EG000|Reported Event|PNS (3 hr/Day)|The PNS (3 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (3 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290123|NCT02928055|EG001|Reported Event|PNS (6 hr/Day)|The PNS (6 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290124|NCT02928055|EG002|Reported Event|PNS (9 hr/Day)|The PNS (9 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (9 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
11290125|NCT02928380|BG000|Baseline|Overall Participants|All the participants received all three treatments (reference denture adhesive, test denture adhesive and no adhesive) in the study period 1, 2, and 3 according to the randomization sequence. Each treatment period was separated by washout period of 2-7 days. All randomized participants were included for baseline evaluation.
11290126|NCT02928380|FG000|Participant Flow|Reference Denture Adhesive/Test Denture Adhesive/No Adhesive|Participants received reference denture adhesive, test denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290127|NCT02928380|FG001|Participant Flow|Reference Denture Adhesive/No Adhesive/Test Denture Adhesive|Participants received reference denture adhesive, no adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290128|NCT02928380|FG002|Participant Flow|Test Denture Adhesive/Reference Denture Adhesive/No Adhesive|Participants received test denture adhesive, reference denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290129|NCT02928380|FG003|Participant Flow|Test Denture Adhesive/No Adhesive/Reference Denture Adhesive|Participants received test denture adhesive, no adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290130|NCT02928380|FG004|Participant Flow|No Adhesive/Reference Denture Adhesive/Test Denture Adhesive|Participants received no adhesive, reference denture adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290131|NCT02928380|FG005|Participant Flow|No Adhesive/Test Denture Adhesive/Reference Denture Adhesive|Participants received no adhesive, test denture adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
11290132|NCT02928380|OG000|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
11290133|NCT02928380|OG001|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
11290134|NCT02928380|OG000|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
11290135|NCT02928380|OG001|Outcome|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
11290136|NCT02928380|OG001|Outcome|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
11290137|NCT02928380|OG002|Outcome|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
11290138|NCT02928380|EG000|Reported Event|Reference Denture Adhesive|Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
11290139|NCT02928380|EG001|Reported Event|Test Denture Adhesive|Participants received test denture adhesive by site staff as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
11290140|NCT02928380|EG002|Reported Event|No Adhesive (Negative Control)|Participants did not receive any denture adhesive by site staff in this treatment arm.
11290141|NCT02928536|BG000|Baseline|Overall Sample|Population aged 15 years or more from 12 European countries
11290142|NCT02928536|FG000|Participant Flow|Overall Sample|Population aged 15 years or more from 12 European countries
11290143|NCT02928536|OG000|Outcome|Overall Sample|Population aged 15 years or more from 12 European countries
11290144|NCT02928536|EG000|Reported Event|Overall Sample|Population aged 15 years or more from 12 European countries
11290145|NCT02928770|BG000|Baseline|Nastent|"A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device.~Nastent: Use of the device while at home and in the sleep lab"
11290146|NCT02928770|FG000|Participant Flow|Nastent|"A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device.~Nastent: Use of the device while at home and in the sleep lab"
11290147|NCT02928770|OG000|Outcome|Nastent|"A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device.~Nastent: Use of the device while at home and in the sleep lab"
11290148|NCT02928770|EG000|Reported Event|Nastent|"A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device.~Nastent: Use of the device while at home and in the sleep lab"
11290149|NCT02928848|BG000|Baseline|Active tDCS, Then Sham|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation condition involves 20 minutes of constant stimulation at 1.5 mA. Arm 1 data were collected prior to active tDCS, whereas Arm 2 data reflect performance 12 weeks following active tDCS (prior to crossing over to the sham tDCS treatment arm).
11290150|NCT02928848|BG001|Baseline|Sham tDCS, Then Active|Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS. Arm 1 data were collected prior to sham tDCS, whereas Arm 2 data reflect performance 12 weeks following sham tDCS (prior to crossing over to the active tDCS treatment arm).
11290151|NCT02928848|BG002|Baseline|Total|Total of all reporting groups
11290152|NCT02928848|FG000|Participant Flow|Active tDCS, Then Sham tDCS|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.
11290153|NCT02928848|FG001|Participant Flow|Sham tDCS, Then Active tDCS|Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
11290154|NCT02928848|OG000|Outcome|Active tDCS, Then Sham tDCS|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS.
11290155|NCT02928848|OG001|Outcome|Sham tDCS, Then Active tDCS|Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS.
11290156|NCT02928848|OG000|Outcome|Active tDCS, Then Sham tDCS|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity.
11290157|NCT02928848|OG001|Outcome|Sham tDCS, Then Active tDCS|Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS.
11290158|NCT02928848|EG000|Reported Event|Active tDCS|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity.
11290159|NCT02928848|EG001|Reported Event|Sham tDCS|Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS.
11290160|NCT02928952|BG000|Baseline|Diabetes Self Management Education (DSME) + Mind-STRIDE|"Will receive routine diabetes self-management education + the Mind-STRIDE intervention~Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education"
11290161|NCT02928952|BG001|Baseline|DSME Alone|Usual care control
10970888|NCT00912795|EG001|Reported Event|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
11290162|NCT02928952|BG002|Baseline|Total|Total of all reporting groups
11290163|NCT02928952|FG000|Participant Flow|Diabetes Self Management Education (DSME) + Mind-STRIDE|"Will receive routine diabetes self-management education + the Mind-STRIDE intervention~Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education"
11290164|NCT02928952|FG001|Participant Flow|DSME Alone|Usual care control
11290165|NCT02928952|OG000|Outcome|Diabetes Self Management Education (DSME) + Mind-STRIDE|"Will receive routine diabetes self-management education + the Mind-STRIDE intervention~Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education"
11290166|NCT02928952|OG001|Outcome|DSME Alone|Usual care control
11290167|NCT02928952|EG000|Reported Event|Diabetes Self Management Education (DSME) + Mind-STRIDE|"Will receive routine diabetes self-management education + the Mind-STRIDE intervention~Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education"
11290168|NCT02928952|EG001|Reported Event|DSME Alone|Usual care control
11290169|NCT02929329|BG000|Baseline|Placebo|Participants received matching placebo tablets (BID).
11290170|NCT02929329|BG001|Baseline|Omecamtiv Mecarbil|Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290171|NCT02929329|BG002|Baseline|Total|Total of all reporting groups
11290172|NCT02929329|FG000|Participant Flow|Placebo|Participants received matching placebo tablets twice a day (BID).
11290173|NCT02929329|FG001|Participant Flow|Omecamtiv Mecarbil|Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290174|NCT02929329|OG000|Outcome|Placebo|Participants received matching placebo tablets (BID).
11290175|NCT02929329|OG001|Outcome|Omecamtiv Mecarbil|Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290176|NCT02929329|OG000|Outcome|Placebo: Oupatients|Participants who had either made an urgent visit to the emergency department or been hospitalized for heart failure within 1 year before screening received placebo tablets twice a day.
10970889|NCT00912808|BG000|Baseline|Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
10970890|NCT00912808|BG001|Baseline|Placebo (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
11290177|NCT02929329|OG001|Outcome|Omecamtiv Mecarbil: Outpatients|Participants who had either made an urgent visit to the emergency department or been hospitalized for heart failure within 1 year before screening received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290178|NCT02929329|OG002|Outcome|Placebo: Inpatients|Participants who were currently hospitalized for heart failure received placebo tablets twice a day.
11290179|NCT02929329|OG003|Outcome|Omecamtiv Mecarbil: Inpatients|Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290180|NCT02929329|EG000|Reported Event|Placebo|Participants received matching placebo tablets (BID).
11290181|NCT02929329|EG001|Reported Event|Omecamtiv Mecarbil|Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
11290182|NCT02929407|BG000|Baseline|FE 204205|"FE 204205, given once daily as 2 hour IV infusion, on three consecutive days. The dose in each subject was escalated from one day to the next if all dose escalation criteria were met.~The dosing regimen for each subject is given below:~Subject 101: Day 1: 0.0325 mg; Subject 102: Day 1: 0.01 mg, Day 2: 0.026 mg, Day 3: 0.05 mg; Subject 103: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.01 mg; Subject 105: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.026 mg."
11290183|NCT02929407|FG000|Participant Flow|FE 204205|"FE 204205, given once daily as 2 hour intravenous (IV) infusion, on three consecutive days. The dose in each subject was escalated from one day to the next if all dose escalation criteria were met.~The dosing regimen for each subject is given below:~Subject 101: Day 1: 0.0325 mg; Subject 102: Day 1: 0.01 mg, Day 2: 0.026 mg, Day 3: 0.05 mg; Subject 103: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.01 mg; Subject 105: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.026 mg."
11290184|NCT02929407|OG000|Outcome|FE 204205|"FE 204205, given once daily as 2 hour IV infusion, on three consecutive days. The dose in each subject was escalated from one day to the next if all dose escalation criteria were met.~The dosing regimen for each subject is given below:~Subject 101: Day 1: 0.0325 mg; Subject 102: Day 1: 0.01 mg, Day 2: 0.026 mg, Day 3: 0.05 mg; Subject 103: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.01 mg; Subject 105: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.026 mg."
11290185|NCT02929407|EG000|Reported Event|FE 204205|"FE 204205, given once daily as 2 hour IV infusion, on three consecutive days. The dose in each subject was escalated from one day to the next if all dose escalation criteria were met.~The dosing regimen for each subject is given below:~Subject 101: Day 1: 0.0325 mg; Subject 102: Day 1: 0.01 mg, Day 2: 0.026 mg, Day 3: 0.05 mg; Subject 103: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.01 mg; Subject 105: Day 1: 0.01 mg, Day 2: 0.01 mg, Day 3: 0.026 mg."
11290186|NCT02929498|BG000|Baseline|Part 1: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
10970891|NCT00912808|BG002|Baseline|Total|Total of all reporting groups
10970892|NCT00912808|FG000|Participant Flow|Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
10970893|NCT00912808|FG001|Participant Flow|Placebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)|Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
10970894|NCT00912808|OG000|Outcome|Donepezil|Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.
10970895|NCT00912808|OG001|Outcome|Placebo|Participants who received Placebo tablet (matching Donepezil) each morning in either the first or last 6 weeks of the study.
11290187|NCT02929498|BG001|Baseline|Part 2: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11290188|NCT02929498|BG002|Baseline|Part 2: GSK2879552+Azacitidine|Part 2 was to be initiated once Part 1 is completed and dose has been selected for GSK2879552 monotherapy and combination of azacitidine with GSK2879552. Treatment with GSK2879552 in this combination therapy arm was to be administered orally once a day at RP2D as continuous daily dosing in each cycle (of 28 days) until disease progression in Part 2 of the study. Azacitidine was to be administered at 75 milligram per meter^2 on Days 1-7 of each 28 day cycle by intravenous (IV) infusion or subcutaneous (SC) injection (route of administration: by physicians choice).
11290189|NCT02929498|BG003|Baseline|Total|Total of all reporting groups
11290190|NCT02929498|FG000|Participant Flow|Part 1: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11290191|NCT02929498|FG001|Participant Flow|Part 2: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11336296|NCT03565068|OG012|Outcome|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11290192|NCT02929498|FG002|Participant Flow|Part 2: GSK2879552+Azacitidine|Part 2 was to be initiated once Part 1 is completed and dose has been selected for GSK2879552 monotherapy and combination of azacitidine with GSK2879552. Treatment with GSK2879552 in this combination therapy arm was to be administered orally once a day at RP2D as continuous daily dosing in each cycle (of 28 days) until disease progression in Part 2 of the study. Azacitidine was to be administered at 75 milligram per meter^2 on Days 1-7 of each 28 day cycle by intravenous (IV) infusion or subcutaneous (SC) injection (route of administration: by physicians choice).
11290193|NCT02929498|OG000|Outcome|Part 1: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11290194|NCT02929498|OG000|Outcome|Part 2: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11290195|NCT02929498|OG001|Outcome|Part 2: GSK2879552+Azacitidine|Part 2 was to be initiated once Part 1 is completed and dose has been selected for GSK2879552 monotherapy and combination of azacitidine with GSK2879552. Treatment with GSK2879552 in this combination therapy arm was to be administered orally once a day at RP2D as continuous daily dosing in each cycle (of 28 days) until disease progression in Part 2 of the study. Azacitidine was to be administered at 75 milligram per meter^2 on Days 1-7 of each 28 day cycle by intravenous (IV) infusion or subcutaneous (SC) injection (route of administration: by physicians choice).
11290196|NCT02929498|EG000|Reported Event|Part 1: GSK2879552|Participants in this monotherapy arm were administered with GSK2879552 0.5 milligrams or 2 milligrams oral capsules once a day as continuous daily dosing in each cycle (of 28 days) until disease progression during Part 1 of the study.
11290197|NCT02929667|BG000|Baseline|Treatment|"Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Fluoxetine: Standard 6 weeks titration, starting 10 mg per day."
11290198|NCT02929667|BG001|Baseline|Control|"Subjects randomized to control arm will receive placebo with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Placebo: Standard 6 weeks titration."
11290199|NCT02929667|BG002|Baseline|Total|Total of all reporting groups
11290200|NCT02929667|FG000|Participant Flow|Treatment|"Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Fluoxetine: Standard 6 weeks titration, starting 10 mg per day."
11290201|NCT02929667|FG001|Participant Flow|Control|"Subjects randomized to control arm will receive placebo with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Placebo: Standard 6 weeks titration."
11290202|NCT02929667|OG000|Outcome|Recruitment|Number of subjects (both fluoxetine and placebo arms) enrolled in the study.
11290203|NCT02929667|OG000|Outcome|Fluoxetine|Subjects randomized to receive fluoxetine.
11290204|NCT02929667|OG001|Outcome|Placebo|Subjects randomized to receive placebo.
11290205|NCT02929667|OG000|Outcome|Fluoxetine|Subjects randomized to fluoxetine.
11290206|NCT02929667|EG000|Reported Event|Fluoxetine|"Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Fluoxetine: Standard 6 weeks titration, starting 10 mg per day."
11290207|NCT02929667|EG001|Reported Event|Placebo|"Subjects randomized to control arm will receive placebo with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.~Placebo: Standard 6 weeks titration."
11290208|NCT02929823|BG000|Baseline|Placebo|"Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks~Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution"
11290209|NCT02929823|BG001|Baseline|0.0002% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution"
11290210|NCT02929823|BG002|Baseline|0.001% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution"
11290211|NCT02929823|BG003|Baseline|Total|Total of all reporting groups
11290212|NCT02929823|FG000|Participant Flow|Placebo|"Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks~Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution"
11290213|NCT02929823|FG001|Participant Flow|0.0002% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution"
11290214|NCT02929823|FG002|Participant Flow|0.001% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution"
11290215|NCT02929823|OG000|Outcome|Placebo|"Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks~Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution"
11290216|NCT02929823|OG001|Outcome|0.0002% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution"
11290217|NCT02929823|OG002|Outcome|0.001% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution"
11290218|NCT02929823|EG000|Reported Event|Placebo|"Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks~Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution"
11290219|NCT02929823|EG001|Reported Event|0.0002% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution"
11290220|NCT02929823|EG002|Reported Event|0.001% SJP-0035 Ophthalmic Solution|"Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.~High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution"
10970896|NCT00912808|OG001|Outcome|Placebo|Participants who received Placebo tablet (matching Donepezil 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.
10970897|NCT00912808|EG000|Reported Event|Donepezil Then Placebo|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6
11290221|NCT02929979|BG000|Baseline|Cognitive Training|Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ. BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations. The investigators will use a suite of BrainHQ exercises designed to target and ameliorate cognitive disruptions in 4 cognitive domains (see main outcome). The investigators will employ basic exercises that focus on increasing processing efficiency in the auditory and visual perceptual and working memory domains, as well as exercises that target impulsivity and cognitive biases. Exercises will be packaged into 4 modules (attention skills, memory skills, executive functioning skills, cognitive control skills) comprised of 4 exercises each. All participants will progress through the same fixed schedule of modules.
11290222|NCT02929979|BG001|Baseline|Placebo Control|Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement with daily computerized activities. It also allows for a double blind study design. Games from the website Sporcle will be used and an online account can be created for each participant.
11290223|NCT02929979|BG002|Baseline|Total|Total of all reporting groups
11290224|NCT02929979|FG000|Participant Flow|Cognitive Training|Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ. BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations.
10970898|NCT00912808|EG001|Reported Event|Placebo Then Donepezil|Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6
11290225|NCT02929979|FG001|Participant Flow|Placebo Control|Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. Games from the website Sporcle were used for each participant.
11290226|NCT02929979|OG000|Outcome|Cognitive Training|Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ. BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations.
11290227|NCT02929979|OG001|Outcome|Placebo Control|Cognitive training placebo control: Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement wi
11290228|NCT02929979|OG001|Outcome|Control Group|This group will receive 22.5 hours of placebo cognitive training over the course of 6 weeks.
11290229|NCT02929979|EG000|Reported Event|Cognitive Training|Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ. BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations.
11290230|NCT02929979|EG001|Reported Event|Placebo Control|Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. Games from the website Sporcle were used for each participant.
11332490|NCT03496428|EG000|Reported Event|Dental Implant Impression Techniques|"Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.~An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined~Dental implant impressions- Different Techniques: Assessment of soft tissues changes with different techniques"
11290231|NCT02930005|BG000|Baseline|Meclofenamic Acid|"150mg meclofenamic acid daily for 8 weeks~Meclofenamic acid"
11290232|NCT02930005|BG001|Baseline|Pentosan Polysulfate Sodium|"300mg of pentosan polysulfate sodium daily for 8 weeks~Pentosan polysulfate sodium"
11290233|NCT02930005|BG002|Baseline|Total|Total of all reporting groups
11290234|NCT02930005|FG000|Participant Flow|Meclofenamic Acid|"150mg meclofenamic acid daily for 8 weeks~Meclofenamic acid"
11290235|NCT02930005|FG001|Participant Flow|Pentosan Polysulfate Sodium|"300mg of pentosan polysulfate sodium daily for 8 weeks~Pentosan polysulfate sodium"
11290236|NCT02930005|OG000|Outcome|Meclofenamic Acid|"150mg meclofenamic acid daily for 8 weeks~Meclofenamic acid"
11290237|NCT02930005|OG001|Outcome|Pentosan Polysulfate Sodium|"300mg of pentosan polysulfate sodium daily for 8 weeks~Pentosan polysulfate sodium"
11290238|NCT02930005|EG000|Reported Event|Meclofenamic Acid|"150mg meclofenamic acid daily for 8 weeks~Meclofenamic acid"
11290239|NCT02930005|EG001|Reported Event|Pentosan Polysulfate Sodium|"300mg of pentosan polysulfate sodium daily for 8 weeks~Pentosan polysulfate sodium"
11332491|NCT03496467|BG000|Baseline|Nepafenac PPDS|"N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)~Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug."
11332492|NCT03496467|BG001|Baseline|Placebo PPDS|"p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).~Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac."
11332493|NCT03496467|BG002|Baseline|Total|Total of all reporting groups
11332494|NCT03496467|FG000|Participant Flow|Nepafenac PPDS|"N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)~Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug."
11332495|NCT03496467|FG001|Participant Flow|Placebo PPDS|"p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).~Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac."
11332496|NCT03496467|OG000|Outcome|Nepafenac PPDS|"N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)~Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug."
11332497|NCT03496467|OG001|Outcome|Placebo PPDS|"p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).~Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac."
11332498|NCT03496467|EG000|Reported Event|Nepafenac PPDS|"N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)~Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug."
11332499|NCT03496467|EG001|Reported Event|Placebo PPDS|"p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).~Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac."
11332500|NCT03496545|BG000|Baseline|Acetaminophen|Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332501|NCT03496545|BG001|Baseline|Bromocriptine and Acetaminophen|Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332502|NCT03496545|BG002|Baseline|Total|Total of all reporting groups
11332503|NCT03496545|FG000|Participant Flow|Acetaminophen|Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
10970899|NCT00912873|BG000|Baseline|0.1% Ropivicaine|ropivicaine 0.1% infusion at 3 mL/hour
11332504|NCT03496545|FG001|Participant Flow|Bromocriptine and Acetaminophen|Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332505|NCT03496545|OG000|Outcome|Acetaminophen|Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332506|NCT03496545|OG001|Outcome|Bromocriptine and Acetaminophen|Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11215952|NCT02302716|BG000|Baseline|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215953|NCT02302716|BG001|Baseline|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215954|NCT02302716|BG002|Baseline|Total|Total of all reporting groups
11215955|NCT02302716|FG000|Participant Flow|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215956|NCT02302716|FG001|Participant Flow|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215957|NCT02302716|OG000|Outcome|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215958|NCT02302716|OG001|Outcome|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215959|NCT02302716|EG000|Reported Event|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine Hagedorn (NPH) QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day (BID) were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
10970900|NCT00912873|BG001|Baseline|0.4% Ropivicaine|ropivicaine 0.4% infusion at 3 mL/hour
11215960|NCT02302716|EG001|Reported Event|LANTUS®|Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD were started at the same dose SC. Participants entering on insulin detemir or NPH twice a day were started at 80% of the total daily dose SC. Participants-driven titration was followed to include the addition of 1 U/day until the fasting blood glucose (FBG) level reaches ≤100 mg/dL (5.6 mmol/L). Participants were allowed to continue oral antihyperglycemic medication (OAM).
11215961|NCT02302807|BG000|Baseline|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
11215962|NCT02302807|BG001|Baseline|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215963|NCT02302807|BG002|Baseline|Total|Total of all reporting groups
11215964|NCT02302807|FG000|Participant Flow|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
11215965|NCT02302807|FG001|Participant Flow|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215966|NCT02302807|OG000|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215967|NCT02302807|OG001|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215968|NCT02302807|OG002|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
11215969|NCT02302807|OG003|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
11290240|NCT02930018|BG000|Baseline|Placebo|"Drug vehicle only~Placebo: Placebo Comparator: Placebo"
11290241|NCT02930018|BG001|Baseline|Nerinetide (NA-1), 2.6 mg/kg|Single intravenous infusion of nerinetide over 10 ± 1 minutes
11290242|NCT02930018|BG002|Baseline|Total|Total of all reporting groups
11290243|NCT02930018|FG000|Participant Flow|Placebo|"Drug vehicle only~Placebo: Placebo Comparator: Placebo"
11290244|NCT02930018|FG001|Participant Flow|Nerinetide (NA-1), 2.6 mg/kg|Single intravenous infusion of nerinetide over 10 ± 1 minutes
11290245|NCT02930018|OG000|Outcome|Placebo|"Drug vehicle only~Placebo: Placebo Comparator: Placebo"
11290246|NCT02930018|OG001|Outcome|Nerinetide, 2.6 mg/kg|Single intravenous infusion of nerinetide over 10 ± 1 minutes
11290247|NCT02930018|EG000|Reported Event|Placebo|"Drug vehicle only~Placebo: Placebo Comparator: Placebo"
11290248|NCT02930018|EG001|Reported Event|Nerinetide, 2.6 mg/kg|Single intravenous infusion of nerinetide over 10 ± 1 minutes
11290249|NCT02930174|BG000|Baseline|Device 1, Then Device 2|"Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2)~Device 1 is a continuous high flow, blower type of generator."
10970901|NCT00912873|BG002|Baseline|Total|Total of all reporting groups
10970902|NCT00912873|FG000|Participant Flow|0.1% Ropivicaine|ropivicaine 0.1% infusion at 12 mL/hour
10970903|NCT00912873|FG001|Participant Flow|0.4% Ropivicaine|ropivicaine 0.4% infusion at 3 mL/hour
10970904|NCT00912873|OG000|Outcome|0.1% Ropivicaine|0.1% Ropivicaine at 12 mL/h
10970905|NCT00912873|OG001|Outcome|0.4% Ropivicaine|0.4% Ropivicaine at 3 mL/h
10970906|NCT00912873|OG000|Outcome|0.1% Ropivicaine|"Patients will be given 0.1% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures.~0.1% Ropivacaine: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)"
11290250|NCT02930174|BG001|Baseline|Device 2, Then Device 1|"Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2).~Device 2 is a critical care ventilator that has a specific NPPV mode."
11290251|NCT02930174|BG002|Baseline|Total|Total of all reporting groups
11290252|NCT02930174|FG000|Participant Flow|Device 1, Then Device 2|"Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study~Device 1 is a continuous high flow, blower type of generator."
11290253|NCT02930174|FG001|Participant Flow|Device 2, Then Device 1|"Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study~Device 2 is a critical care ventilator that has a specific NPPV mode."
11290254|NCT02930174|OG000|Outcome|Respironics V-60|This device is a continuous high flow, blower type of generator.
11290255|NCT02930174|OG001|Outcome|Draeger V-500|This device is an ICU ventilator
11290256|NCT02930174|OG001|Outcome|Drager V-500|This device is an ICU ventilator.
11290257|NCT02930174|OG000|Outcome|Respironics V-60|This device is a continuous high flow, blower type of generator (Respironics V-60).
11290258|NCT02930174|OG001|Outcome|Drager V-500|This device is an ICU ventilator
11290259|NCT02930174|EG000|Reported Event|Volunteer|"Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 and Drager V-500.~Respironics V-60: Continuous high flow, blower type of generator.~Drager V-500: Critical care ventilator that has a specific NPPV mode."
11290260|NCT02930226|BG000|Baseline|1 Unit, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290261|NCT02930226|BG001|Baseline|1 Unit, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290262|NCT02930226|BG002|Baseline|2 Units, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290263|NCT02930226|BG003|Baseline|2 Units, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11332507|NCT03496545|EG000|Reported Event|Acetaminophen|Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332508|NCT03496545|EG001|Reported Event|Bromocriptine and Acetaminophen|Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
11332509|NCT03496701|BG000|Baseline|Overall Study|"All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.~Test lens: contact lens~control lens: contact lens"
11332510|NCT03496701|FG000|Participant Flow|Overall Study|"All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.~Test lens: contact lens~control lens: contact lens"
11332511|NCT03496701|OG000|Outcome|Stenfilcon A Test Lens|"All subjects will first wear stenfilcon A test contact lenses for one week.~stenfilcon A test lens: contact lens"
11290264|NCT02930226|BG004|Baseline|3 Units Per Crossover Infusion FDP-ACD x FFP|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290265|NCT02930226|BG005|Baseline|3 Units Per Crossover Infusion FFP x FDP-ACD|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290266|NCT02930226|BG006|Baseline|Total|Total of all reporting groups
11290267|NCT02930226|FG000|Participant Flow|1 Unit, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290268|NCT02930226|FG001|Participant Flow|1 Unit, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290269|NCT02930226|FG002|Participant Flow|2 Units, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290270|NCT02930226|FG003|Participant Flow|2 Units, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290271|NCT02930226|FG004|Participant Flow|3 Units Per Crossover Infusion FDP-ACD x FFP|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290272|NCT02930226|FG005|Participant Flow|3 Units Per Crossover Infusion FFP x FDP-ACD|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290273|NCT02930226|OG000|Outcome|1 Unit, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290274|NCT02930226|OG001|Outcome|1 Unit, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290275|NCT02930226|OG002|Outcome|2 Units, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290276|NCT02930226|OG003|Outcome|2 Units, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290277|NCT02930226|OG004|Outcome|3 Units Per Crossover Infusion FDP-ACD x FFP|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290278|NCT02930226|OG005|Outcome|3 Units Per Crossover Infusion FFP x FDP-ACD|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11332512|NCT03496701|OG001|Outcome|Stenfilcon A Control Lens|"All subjects will first wear stenfilcon A control contact lenses for one week.~stenfilcon A control lens: contact lens"
11332513|NCT03496701|EG000|Reported Event|Stenfilcon A Test Lens|"All subjects will first wear stenfilcon A test contact lenses for one week.~stenfilcon A test lens: contact lens"
11332514|NCT03496701|EG001|Reported Event|Stenfilcon A Control Lens|"All subjects will first wear stenfilcon A control contact lenses for one week.~stenfilcon A control lens: contact lens"
11290279|NCT02930226|OG000|Outcome|3 Units Per Crossover Infusion FDP-ACD x FFP|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290280|NCT02930226|OG001|Outcome|3 Units Per Crossover Infusion FFP x FDP-ACD|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290281|NCT02930226|EG000|Reported Event|1 Unit, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290282|NCT02930226|EG001|Reported Event|1 Unit, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290283|NCT02930226|EG002|Reported Event|2 Units, Single Infusion FDP-CPD|"Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290284|NCT02930226|EG003|Reported Event|2 Units, Single Infusion FDP-ACD|"Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers"
11290285|NCT02930226|EG004|Reported Event|3 Units Per Crossover Infusion FDP-ACD x FFP|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290286|NCT02930226|EG005|Reported Event|3 Units Per Crossover Infusion FFP x FDP-ACD|"Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion~Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers~Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only"
11290287|NCT02930343|BG000|Baseline|Group 1- MTX+LEF+HCQ|"Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week."
11290288|NCT02930343|BG001|Baseline|Group 2- MTX+SSZ+HCQ|"Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.~Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)"
11290289|NCT02930343|BG002|Baseline|Total|Total of all reporting groups
11332515|NCT03496974|BG000|Baseline|Group A: 200 mg Cohort|Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
11332516|NCT03496974|BG001|Baseline|Group B: 400 mg Cohort|Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
11332517|NCT03496974|BG002|Baseline|Total|Total of all reporting groups
11332518|NCT03496974|FG000|Participant Flow|200 mg Cohort|Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
11290290|NCT02930343|FG000|Participant Flow|Group 1- MTX+LEF+HCQ|"Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week."
11290291|NCT02930343|FG001|Participant Flow|Group 2- MTX+SSZ+HCQ|"Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.~Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)"
11290292|NCT02930343|OG000|Outcome|Group 1- MTX+LEF+HCQ|"Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week."
11290293|NCT02930343|OG001|Outcome|Group 2- MTX+SSZ+HCQ|"Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.~Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)"
11290294|NCT02930343|EG000|Reported Event|Group 1- MTX+LEF+HCQ|"Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week."
11332519|NCT03496974|FG001|Participant Flow|400 mg Cohort|Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
11332520|NCT03496974|OG000|Outcome|Group A: 200 mg Cohort|Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
11332521|NCT03496974|OG001|Outcome|Group B: 400 mg Cohort|Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
11290295|NCT02930343|EG001|Reported Event|Group 2- MTX+SSZ+HCQ|"Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.~Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases~Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.~Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)~Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.~Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)"
11290296|NCT02930824|BG000|Baseline|Adult Genotype Guided Treatment|"For adults randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290297|NCT02930824|BG001|Baseline|Adult Conventional Treatment|For adults randomized to the conventional arm no genotype will be provided to physicians to assist in dosing.
11290298|NCT02930824|BG002|Baseline|Pediatric Genotype Guided Treatment|"For children randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290299|NCT02930824|BG003|Baseline|Pediatric Conventional Treatment|For children randomized to the conventional arm no genotype will be provided to physicians to assist in dosing.
11290300|NCT02930824|BG004|Baseline|Total|Total of all reporting groups
11290301|NCT02930824|FG000|Participant Flow|Adult Genotype Guided Treatment|"For adults randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290302|NCT02930824|FG001|Participant Flow|Adult Conventional Treatment|For adults randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11290303|NCT02930824|FG002|Participant Flow|Pediatric Genotype Guided Treatment|"For children randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290304|NCT02930824|FG003|Participant Flow|Pediatric Conventional Treatment|For children randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11290305|NCT02930824|OG000|Outcome|Adult Genotype Guided Treatment|"For adults randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290306|NCT02930824|OG001|Outcome|Adult Conventional Treatment|For adults randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11290307|NCT02930824|OG002|Outcome|Pediatric Genotype Guided Treatment|"For children randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290308|NCT02930824|OG003|Outcome|Pediatric Conventional Treatment|For children randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11290309|NCT02930824|OG000|Outcome|Adult Genotype Guided Treatment|"For patients randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290310|NCT02930824|OG001|Outcome|Adult Conventional Treatment|For patients randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11290311|NCT02930824|OG001|Outcome|Adult Conventional Treatment|For patients randomized to the genotype-supported arm a no genotype will be provided to physicians to assist in dosing.
11290312|NCT02930824|OG003|Outcome|Pediatric Conventional Treatment|For children randomized to the genotype-supported arm a no genotype will be provided to physicians to assist in dosing.
11290313|NCT02930824|OG000|Outcome|Adult Genotype Guided Treatment|"For Adults randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290314|NCT02930824|OG001|Outcome|Adult Conventional Treatment|For Adults randomized to the genotype-supported arm no genotype will be provided to physicians to assist in dosing.
11332522|NCT03496974|EG000|Reported Event|200 mg Cohort|Bermekimab Monoclonal Antibody 200 mg: 200 mg subcutaneous injection
11332523|NCT03496974|EG001|Reported Event|400 mg Cohort|Bermekimab Monoclonal Antibody 400 mg: 400 mg subcutaneous injection
11290315|NCT02930824|EG000|Reported Event|Adult Genotype Guided Treatment|"For adults randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290316|NCT02930824|EG001|Reported Event|Adult Conventional Treatment|For adults randomized to the conventional arm no genotype will be provided to physicians to assist in dosing.
11290317|NCT02930824|EG002|Reported Event|Pediatric Genotype Guided Treatment|"For children randomized to the genotype-supported arm a CYP2C19 genotype will be provided to physicians to assist in dosing.~CYP2C19 genotyping: All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced."
11290318|NCT02930824|EG003|Reported Event|Pediatric Conventional Treatment|For children randomized to the conventional arm no genotype will be provided to physicians to assist in dosing.
11290319|NCT02930837|BG000|Baseline|Alteplase (Rt-PA)|Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
11290320|NCT02930837|FG000|Participant Flow|Alteplase (Rt-PA)|Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
11290321|NCT02930837|OG000|Outcome|Alteplase (Rt-PA)|Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
11290322|NCT02930837|EG000|Reported Event|Alteplase (Rt-PA)|Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
11290323|NCT02930941|BG000|Baseline|TXA Group|Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290324|NCT02930941|BG001|Baseline|NS Group|Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290325|NCT02930941|BG002|Baseline|Total|Total of all reporting groups
11290326|NCT02930941|FG000|Participant Flow|Tranexamic Acid (100 mg/mL)|"TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).~Tranexamic Acid: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s)."
11290327|NCT02930941|FG001|Participant Flow|0.9% Sodium Chloride|"0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).~0.9% Sodium Chloride: 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s)."
11290328|NCT02930941|OG000|Outcome|TXA Group|Tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290329|NCT02930941|OG001|Outcome|NS Group|0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290330|NCT02930941|OG000|Outcome|TXA Group|Tranexamic group
11290331|NCT02930941|OG001|Outcome|NS Group|Normal saline
11290332|NCT02930941|OG000|Outcome|TXA Group|Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290333|NCT02930941|OG001|Outcome|NS Group|Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290334|NCT02930941|EG000|Reported Event|TXA Group|Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290335|NCT02930941|EG001|Reported Event|NS Group|Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
11290336|NCT02930980|BG000|Baseline|Investigational Software|"Investigational Software loaded on Micra device~Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device"
11290337|NCT02930980|FG000|Participant Flow|Investigational Software|"Investigational Software loaded on Micra device~Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device"
11290338|NCT02930980|OG000|Outcome|Investigational Software|"Investigational Software loaded on Micra device~Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device"
11290339|NCT02930980|EG000|Reported Event|Investigational Software|Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device
11290340|NCT02931045|BG000|Baseline|Ticagrelor|Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
11290341|NCT02931045|BG001|Baseline|Clopidogrel|Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
11290342|NCT02931045|BG002|Baseline|Total|Total of all reporting groups
11290343|NCT02931045|FG000|Participant Flow|Ticagrelor|Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
11290344|NCT02931045|FG001|Participant Flow|Clopidogrel|Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
11290345|NCT02931045|OG000|Outcome|Ticagrelor|"Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)~27 patients"
11290346|NCT02931045|OG001|Outcome|Clopidogrel|"Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)~28 patients"
11290347|NCT02931045|EG000|Reported Event|Ticagrelor|"Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)~27 patients~One major bleeding event from the gynecologic tract"
11290348|NCT02931045|EG001|Reported Event|Clopidogrel|"Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)~28 patients~One major bleeding event from a diabetic foot ulcer"
11290349|NCT02931253|BG000|Baseline|Metformin Group|"Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.~Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.~Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals."
11290350|NCT02931253|BG001|Baseline|Control Group|Standard of care - ablation only
11290351|NCT02931253|BG002|Baseline|Total|Total of all reporting groups
11290352|NCT02931253|FG000|Participant Flow|Metformin Group|"Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.~Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.~Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals."
11290353|NCT02931253|FG001|Participant Flow|Control Group|Standard of care - ablation only
11290354|NCT02931253|OG000|Outcome|Metformin Group|"Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.~Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.~Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals."
11290355|NCT02931253|OG001|Outcome|Control Group|Standard of care - ablation only
11290356|NCT02931253|EG000|Reported Event|Metformin Group|"Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.~Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.~Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals."
11290357|NCT02931253|EG001|Reported Event|Control Group|Standard of care - ablation only
11290358|NCT02931396|BG000|Baseline|FES Intervention|"Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home.~FES"
11290359|NCT02931396|BG001|Baseline|Control|Participants will be asked to continue their activities of daily living as usual.
11290360|NCT02931396|BG002|Baseline|Total|Total of all reporting groups
11290361|NCT02931396|FG000|Participant Flow|FES Intervention|"Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home.~FES"
11290362|NCT02931396|FG001|Participant Flow|Control|Participants will be asked to continue their activities of daily living as usual.
11290363|NCT02931396|OG000|Outcome|FES Intervention|"Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home.~FES"
11290364|NCT02931396|OG001|Outcome|Control|Participants will be asked to continue their activities of daily living as usual.
11290365|NCT02931396|EG000|Reported Event|FES Intervention|"Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home.~FES"
11290366|NCT02931396|EG001|Reported Event|Control|Participants will be asked to continue their activities of daily living as usual.
11290367|NCT02931539|BG000|Baseline|Investigator-assigned Anti-CMV Treatment (IAT)|Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
11290368|NCT02931539|BG001|Baseline|Maribavir 400 mg|Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290369|NCT02931539|BG002|Baseline|Total|Total of all reporting groups
11290370|NCT02931539|FG000|Participant Flow|Investigator-assigned Anti-CMV Treatment (IAT)|Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
11290371|NCT02931539|FG001|Participant Flow|Maribavir 400 mg|Participants received maribavir 400 milligram (mg) (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290372|NCT02931539|FG002|Participant Flow|Maribavir Rescue Arm|Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290373|NCT02931539|OG000|Outcome|Investigator-assigned Anti-CMV Treatment (IAT)|Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
11290374|NCT02931539|OG001|Outcome|Maribavir 400 mg|Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290375|NCT02931539|OG001|Outcome|Maribavir Rescue Arm|Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290376|NCT02931539|OG002|Outcome|Maribavir 400 mg|Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290377|NCT02931539|OG000|Outcome|Maribavir Rescue Arm|Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290378|NCT02931539|OG000|Outcome|Investigator-assigned Anti-CMV Treatment (IAT)|Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
11290379|NCT02931539|OG000|Outcome|Maribavir 400 mg|Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290380|NCT02931539|EG000|Reported Event|IAT: Ganciclovir/ Valganciclovir|Participants received ganciclovir intravenously or valganciclovir orally based on the the investigator's discretion for the 8 week treatment period.
11290381|NCT02931539|EG001|Reported Event|IAT: Foscarnet|Participants received foscarnet intravenously based on investigator's discretion for the 8 week treatment period.
11290382|NCT02931539|EG002|Reported Event|IAT: Cidofovir|Participants received cidofovir intravenously based on the investigator's discretion for the 8 week treatment period.
11290383|NCT02931539|EG003|Reported Event|IAT: Foscarnet + Ganciclovir/ Valganciclovir|Participants received foscarnet intravenously in combination with ganciclovir intravenously or valganciclovir orally based on investigator's discretion for the 8 week treatment period.
11290384|NCT02931539|EG004|Reported Event|Maribavir 400 mg|Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290385|NCT02931539|EG005|Reported Event|Maribavir Rescue Arm|Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
11290386|NCT02931565|BG000|Baseline|Placebo or Olinciguat|Matching placebo administered orally or single 5-mg dose of olinciguat administered orally
11290387|NCT02931565|FG000|Participant Flow|Placebo|Matching placebo administered orally
11290388|NCT02931565|FG001|Participant Flow|Olinciguat|Single 5-mg dose of olinciguat administered orally
11290389|NCT02931565|OG000|Outcome|Placebo|Matching placebo administered orally
11290390|NCT02931565|OG001|Outcome|Olinciguat|Single 5-mg dose of olinciguat administered orally
11290391|NCT02931565|OG000|Outcome|Olinciguat|Single 5-mg dose of olinciguat administered orally
11290392|NCT02931565|EG000|Reported Event|Placebo|Matching placebo administered orally
11290393|NCT02931565|EG001|Reported Event|Olinciguat|Single 5-mg dose of olinciguat administered orally
11290394|NCT02931838|BG000|Baseline|Placebo|Placebo for BMS-986165
11290395|NCT02931838|BG001|Baseline|BMS-986165 3MG QOD|BMS-986165 3mg capsules Every Other Day
11290396|NCT02931838|BG002|Baseline|BMS-986165 3MG QD|BMS-986165 3 mg capsules every day
11290397|NCT02931838|BG003|Baseline|BMS-986165 3MG BID|BMS-986165 3 mg capsules twice daily
11290398|NCT02931838|BG004|Baseline|BMS-986165 6MG BID|BMS-986165 6 mg capsules twice daily
11290399|NCT02931838|BG005|Baseline|BMS-986165 12MG QD|BMS-986165 12 mg capsules every day
11290400|NCT02931838|BG006|Baseline|Total|Total of all reporting groups
11290401|NCT02931838|FG000|Participant Flow|Placebo|Placebo for BMS-986165
11290402|NCT02931838|FG001|Participant Flow|BMS-986165 3MG QOD|BMS-986165 3mg capsules Every Other Day
11290403|NCT02931838|FG002|Participant Flow|BMS-986165 3MG QD|BMS-986165 3mg capsules Every Day
11290404|NCT02931838|FG003|Participant Flow|BMS-986165 3MG BID|BMS-986165 3mg capsules Twice Daily
11290405|NCT02931838|FG004|Participant Flow|BMS-986165 6MG BID|BMS-986165 6mg capsules Twice Daily
11290406|NCT02931838|FG005|Participant Flow|BMS-986165 12MG QD|BMS-986165 12mg capsules Every Day
11290407|NCT02931838|OG000|Outcome|Placebo|Placebo for BMS-986165
11290408|NCT02931838|OG001|Outcome|BMS-986165 3MG QOD|BMS-986165 3mg capsules Every Other Day
11290409|NCT02931838|OG002|Outcome|BMS-986165 3MG QD|BMS-986165 3 mg capsules every day
11290410|NCT02931838|OG003|Outcome|BMS-986165 3MG BID|BMS-986165 3 mg capsules twice daily
11290411|NCT02931838|OG004|Outcome|BMS-986165 6MG BID|BMS-986165 6 mg capsules twice daily
11290412|NCT02931838|OG005|Outcome|BMS-986165 12MG QD|BMS-986165 12 mg capsules every day
11290413|NCT02931838|OG000|Outcome|BMS-986165 3MG QOD|BMS-986165 3mg capsules Every Other Day
11290414|NCT02931838|OG001|Outcome|BMS-986165 3MG QD|BMS-986165 3 mg capsules every day
11290415|NCT02931838|OG002|Outcome|BMS-986165 3MG BID|BMS-986165 3 mg capsules twice daily
11290416|NCT02931838|OG003|Outcome|BMS-986165 6MG BID|BMS-986165 6 mg capsules twice daily
11290417|NCT02931838|OG004|Outcome|BMS-986165 12MG QD|BMS-986165 12 mg capsules every day
11290418|NCT02931838|EG000|Reported Event|Placebo|Placebo for BMS-986165
11290419|NCT02931838|EG001|Reported Event|BMS-986165 3mg QOD|BMS-986165 3mg capsules Every Other Day
11290420|NCT02931838|EG002|Reported Event|BMS-986165 3mg QD|BMS-986165 3 mg capsules every day
11290421|NCT02931838|EG003|Reported Event|BMS-986165 3mg BID|BMS-986165 3 mg capsules twice daily
11290422|NCT02931838|EG004|Reported Event|BMS-986165 6mg BID|BMS-986165 6 mg capsules twice daily
11290423|NCT02931838|EG005|Reported Event|BMS-986165 12mg QD|BMS-986165 12 mg capsules every day
11290424|NCT02932228|BG000|Baseline|ImPACT|Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization.
11290425|NCT02932228|BG001|Baseline|PACT|Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services.
11290426|NCT02932228|BG002|Baseline|Total|Total of all reporting groups
11290427|NCT02932228|FG000|Participant Flow|ImPACT|Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization.
11290428|NCT02932228|FG001|Participant Flow|PACT|Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services.
11290429|NCT02932228|OG000|Outcome|ImPACT|Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization.
11290430|NCT02932228|OG001|Outcome|PACT|Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
11290431|NCT02932228|OG001|Outcome|PACT|Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services.
11290432|NCT02932228|OG000|Outcome|Providers at VAPAHCS|Clinicians and leadership at VAPAHCS impacted by implementation of the ImPACT program
11290433|NCT02932228|EG000|Reported Event|ImPACT|Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization.
11290434|NCT02932228|EG001|Reported Event|PACT|Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services.
11290435|NCT02932267|BG000|Baseline|Adapalene / BPO Gel|"Adapalene 0.3% / BPO 2.5% gel, once daily in the evening~Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks"
11332524|NCT03496987|BG000|Baseline|Manual Drainage|Patients undergo drainage of pleural fluid via manual (syringe) system
11332525|NCT03496987|BG001|Baseline|Vacuum Bottle Drainage|"Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)~Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles"
11332526|NCT03496987|BG002|Baseline|Total|Total of all reporting groups
11332527|NCT03496987|FG000|Participant Flow|Manual Drainage|Patients undergo drainage of pleural fluid via manual (syringe) system
11332528|NCT03496987|FG001|Participant Flow|Vacuum Bottle Drainage|"Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)~Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles"
11332529|NCT03496987|OG000|Outcome|Manual Drainage|Patients undergo drainage of pleural fluid via manual (syringe) system
11332530|NCT03496987|OG001|Outcome|Vacuum Bottle Drainage|"Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)~Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles"
11290436|NCT02932267|FG000|Participant Flow|Adapalene / BPO Gel|"Adapalene 0.3% / BPO 2.5% gel, once daily in the evening~Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks"
11290437|NCT02932267|OG000|Outcome|Adapalene / BPO Gel|"Adapalene 0.3% / BPO 2.5% gel, once daily in the evening~Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks"
11290438|NCT02932267|EG000|Reported Event|Adapalene / BPO Gel|"Adapalene 0.3% / BPO 2.5% gel, once daily in the evening~Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks"
11290439|NCT02932306|BG000|Baseline|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290440|NCT02932306|BG001|Baseline|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290441|NCT02932306|BG002|Baseline|Total|Total of all reporting groups
11290442|NCT02932306|FG000|Participant Flow|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290443|NCT02932306|FG001|Participant Flow|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290444|NCT02932306|OG000|Outcome|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290445|NCT02932306|OG001|Outcome|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290446|NCT02932306|EG000|Reported Event|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290447|NCT02932306|EG001|Reported Event|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11290448|NCT02932462|BG000|Baseline|DSXS 1535|"DSXS 1535 topical product~DSXS: topical product"
11290449|NCT02932462|BG001|Baseline|Placebo|"Vehicle~Placebo: topical product"
11290450|NCT02932462|BG002|Baseline|Total|Total of all reporting groups
11290451|NCT02932462|FG000|Participant Flow|DSXS 1535|"DSXS 1535 topical product~DSXS: topical product"
11290452|NCT02932462|FG001|Participant Flow|Placebo|"Vehicle~Placebo: topical product"
11290453|NCT02932462|OG000|Outcome|DSXS 1535|"DSXS 1535 topical product~DSXS: topical product"
11290454|NCT02932462|OG001|Outcome|Placebo|"Vehicle~Placebo: topical product"
11290455|NCT02932462|EG000|Reported Event|DSXS 1535|"DSXS 1535 topical product~DSXS: topical product"
11290456|NCT02932462|EG001|Reported Event|Placebo|"Vehicle~Placebo: topical product"
11290457|NCT02932787|BG000|Baseline|Height-adjustable Workstation|"Participants received a height-adjustable workstation for four weeks~Height-adjustable workstation"
11290458|NCT02932787|BG001|Baseline|Control|
11290459|NCT02932787|BG002|Baseline|Total|Total of all reporting groups
11290460|NCT02932787|FG000|Participant Flow|Height-adjustable Workstation|"Participants received a height-adjustable workstation for four weeks~Height-adjustable workstation"
11290461|NCT02932787|FG001|Participant Flow|Control|
11290462|NCT02932787|OG000|Outcome|Height-adjustable Workstation|Participants that received a height-adjustable workstation
11290463|NCT02932787|OG001|Outcome|Control|Participants that did not receive a height-adjustable workstation
11290464|NCT02932787|OG000|Outcome|Height-adjustable Workstation|"Participants received a height-adjustable workstation for four weeks~Height-adjustable workstation"
11290465|NCT02932787|OG000|Outcome|Height-adjustable Workstation|Participants received a height-adjustable workstation
11290466|NCT02932787|OG001|Outcome|Control|Participants that did not received a height-adjustable workstation
11290467|NCT02932787|EG000|Reported Event|Height-adjustable Workstation|Participants received a height-adjustable workstation for four weeks
11290468|NCT02932787|EG001|Reported Event|Control|Participants that did not receive a height-adjustable workstation
11290469|NCT02932878|BG000|Baseline|DSXS Topical Cohort 1|"administered twice daily for 28 days in patients age 12-18 years of age~DSXS topical: topical treatment"
11290470|NCT02932878|BG001|Baseline|DSXS Topical Cohort 2|"administered twice daily for 28 days in patients age 6-11 years or age~DSXS topical: topical treatment"
11290471|NCT02932878|BG002|Baseline|Total|Total of all reporting groups
11290472|NCT02932878|FG000|Participant Flow|DSXS Topical Cohort 1|"administered twice daily for 28 days in patients age 12-18 years of age~DSXS topical: topical treatment"
11290473|NCT02932878|FG001|Participant Flow|DSXS Topical Cohort 2|"administered twice daily for 28 days in patients age 6-11 years or age~DSXS topical: topical treatment"
11290474|NCT02932878|OG000|Outcome|DSXS Topical Cohort 1|"administered twice daily for 28 days in patients age 12-18 years of age~DSXS topical: topical treatment"
11290475|NCT02932878|OG001|Outcome|DSXS Topical Cohort 2|"administered twice daily for 28 days in patients age 6-11 years or age~DSXS topical: topical treatment"
11290476|NCT02932878|EG000|Reported Event|DSXS Topical Cohort 1|"administered twice daily for 28 days in patients age 12-18 years of age~DSXS topical: topical treatment"
11290477|NCT02932878|EG001|Reported Event|DSXS Topical Cohort 2|"administered twice daily for 28 days in patients age 6-11 years or age~DSXS topical: topical treatment"
11290478|NCT02932891|BG000|Baseline|DSXS Topical Cohort 1|"active treatment~DSXS topical: topical treatment"
11290479|NCT02932891|FG000|Participant Flow|DSXS Topical Cohort 1|"active treatment~DSXS topical: topical treatment"
11290480|NCT02932891|OG000|Outcome|DSXS Topical Cohort 1|"active treatment~DSXS topical: topical treatment"
11290481|NCT02932891|EG000|Reported Event|DSXS Topical Cohort 1|"active treatment~DSXS topical: topical treatment"
11290482|NCT02932904|BG000|Baseline|Placebo|Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.
11290483|NCT02932904|BG001|Baseline|Paroxetine 20 mg|Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290484|NCT02932904|BG002|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290485|NCT02932904|BG003|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
11290486|NCT02932904|BG004|Baseline|Total|Total of all reporting groups
11290487|NCT02932904|FG000|Participant Flow|Placebo|Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.
11290488|NCT02932904|FG001|Participant Flow|Paroxetine 20 mg|Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290489|NCT02932904|FG002|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290490|NCT02932904|FG003|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
11290491|NCT02932904|OG000|Outcome|Paroxetine 20 mg|Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290492|NCT02932904|OG001|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290493|NCT02932904|OG002|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
11290494|NCT02932904|OG000|Outcome|Placebo|Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.
11290495|NCT02932904|OG001|Outcome|Paroxetine 20 mg|Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290496|NCT02932904|OG002|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290497|NCT02932904|OG003|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
11290498|NCT02932904|EG000|Reported Event|Placebo|Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.
11290499|NCT02932904|EG001|Reported Event|Paroxetine 20 mg|Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290500|NCT02932904|EG002|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
11290501|NCT02932904|EG003|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
11290502|NCT02932943|BG000|Baseline|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290503|NCT02932943|BG001|Baseline|Rapastinel 450 mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290504|NCT02932943|BG002|Baseline|Total|Total of all reporting groups
11290505|NCT02932943|FG000|Participant Flow|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290506|NCT02932943|FG001|Participant Flow|Rapastinel 450 mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290507|NCT02932943|OG000|Outcome|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290508|NCT02932943|OG001|Outcome|Rapastinel 450 mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290509|NCT02932943|EG000|Reported Event|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290510|NCT02932943|EG001|Reported Event|Rapastinel 450 mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11290511|NCT02933034|BG000|Baseline|Coronary Disease Patients|Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
11290512|NCT02933034|FG000|Participant Flow|Coronary Disease Patients|Participants receive 2 cardiac MRI procedures: manganese-enhanced MRI (MEMRI; manganese 0.28 mL/kg as reagent); and delayed-enhanced MRI (DEMRI; gadolinium 0.2 mmol/kg as reagent).
11290513|NCT02933034|OG000|Outcome|Coronary Disease Patients|Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
11290514|NCT02933034|EG000|Reported Event|Coronary Disease Patients|Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as a reagent); and DEMRI (gadolinium 0.2 mmol/kg as a reagent).
11290515|NCT02933060|BG000|Baseline|IV Fluid Bolus|"Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.~Normal saline (1000 mL)"
11290516|NCT02933060|BG001|Baseline|Control|"Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.~Control"
11290517|NCT02933060|BG002|Baseline|Total|Total of all reporting groups
11290518|NCT02933060|FG000|Participant Flow|IV Fluid Bolus|"Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.~Normal saline (1000 mL)"
11290519|NCT02933060|FG001|Participant Flow|Control|"Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.~Control"
11290520|NCT02933060|OG000|Outcome|IV Fluid Bolus|"Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.~Normal saline (1000 mL)"
11290521|NCT02933060|OG001|Outcome|Control|"Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.~Control"
11290522|NCT02933060|EG000|Reported Event|IV Fluid Bolus|"Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.~Normal saline (1000 mL)"
11290523|NCT02933060|EG001|Reported Event|Control|"Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.~Control"
11290524|NCT02933320|BG000|Baseline|Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase|"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).~BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206."
11290525|NCT02933320|BG001|Baseline|Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase|"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).~Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab."
11290526|NCT02933320|BG002|Baseline|Part B: Arm1: BI-1206 Single Agent Expansion Phase|"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.~BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D."
11290527|NCT02933320|BG003|Baseline|Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase|"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.~Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D."
11290528|NCT02933320|BG004|Baseline|Total|Total of all reporting groups
11290529|NCT02933320|FG000|Participant Flow|Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase|"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).~BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206."
11290530|NCT02933320|FG001|Participant Flow|Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase|"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).~Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab."
11290531|NCT02933320|FG002|Participant Flow|Part B: Arm1: BI-1206 Single Agent Expansion Phase|"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.~BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D."
11290532|NCT02933320|FG003|Participant Flow|Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase|"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.~Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D."
11290533|NCT02933320|OG000|Outcome|Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase|"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).~BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206."
11290534|NCT02933320|OG001|Outcome|Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase|"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).~Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab."
11290535|NCT02933320|OG002|Outcome|Part B: Arm1: BI-1206 Single Agent Expansion Phase|"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.~BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D."
11290536|NCT02933320|OG003|Outcome|Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase|"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.~Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D."
11290537|NCT02933320|EG000|Reported Event|Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase|"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).~BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206."
11290538|NCT02933320|EG001|Reported Event|Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase|"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).~Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab."
11290539|NCT02933320|EG002|Reported Event|Part B: Arm1: BI-1206 Single Agent Expansion Phase|"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.~BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D."
11332531|NCT03496987|EG000|Reported Event|Manual Drainage|Patients undergo drainage of pleural fluid via manual (syringe) system
11332532|NCT03496987|EG001|Reported Event|Vacuum Bottle Drainage|"Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)~Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles"
11290540|NCT02933320|EG003|Reported Event|Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase|"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.~Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D."
11290541|NCT02933372|BG000|Baseline|Parkinson's Disease Patients|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.
11290542|NCT02933372|BG001|Baseline|Healthy Controls|: Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, and 0.5mg twice a day.
11290543|NCT02933372|BG002|Baseline|Total|Total of all reporting groups
11290544|NCT02933372|FG000|Participant Flow|Parkinson's Disease Patients|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.
11290545|NCT02933372|FG001|Participant Flow|Healthy Controls|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, and 0.5mg twice a day.
11290546|NCT02933372|OG000|Outcome|Parkinson's Disease Patients|"Participants take varenicline for several days and have two Positron Emission Tomography (PET) scans. PET scans are used to estimate how much varenicline is actually in the brain. Safety monitoring with clinical assessments of severity of Parkinson disease (PD) and cognition are performed.~Varenicline: Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.~[18-Fluorine] Flubatine PET Scan: Participants will undergo 2 different PET scanning sessions. Radiotracers will be injected into the participant's vein through an IV (intravenous catheter or plastic tube inserted in an arm vein). A tracer refers to a small amount of a radioactive substance that does not alter body function.~Evaluation by Investigator: Participants will undergo cognitive testing, a physical exam, and gait and posture assessments"
11290547|NCT02933372|OG001|Outcome|Healthy Controls|"Participants take varenicline for several days and have two Positron Emission Tomography (PET) scans. The PET scans are used to estimate how much varenicline is actually in the brain. Safety monitoring with clinical assessments for presence of Parkinson disease (PD) and cognition are performed.~Varenicline: Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.~[18-Fluorine] Flubatine PET Scan: Participants will undergo 2 different PET scanning sessions. Radiotracers will be injected into the participant's vein through an IV (intravenous catheter or plastic tube inserted in an arm vein). A tracer refers to a small amount of a radioactive substance that does not alter body function.~Evaluation by Investigator: Participants will undergo cognitive testing, a physical exam, and gait and posture assessments"
11290548|NCT02933372|EG000|Reported Event|Parkinson's Disease Patients|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.
11290549|NCT02933372|EG001|Reported Event|Healthy Controls|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, and 0.5mg twice a day.
11290550|NCT02933450|BG000|Baseline|Patiromer Group|Single dose of Patiromer 25.2 g + Standard of Care
11290551|NCT02933450|BG001|Baseline|Standard of Care Group|Standard of Care
11290552|NCT02933450|BG002|Baseline|Total|Total of all reporting groups
11290553|NCT02933450|FG000|Participant Flow|Patiromer|Single dose of Patiromer 25.2 g + Standard of Care
11290554|NCT02933450|FG001|Participant Flow|Standard of Care|Standard of Care
11290555|NCT02933450|OG000|Outcome|Patiromer|Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy
11290556|NCT02933450|OG001|Outcome|Standard of Care|subjects receiving standard of care therapy
11290557|NCT02933450|EG000|Reported Event|Patiromer|Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy
11290558|NCT02933450|EG001|Reported Event|Standard of Care|subjects receiving standard of care therapy
11290559|NCT02933476|BG000|Baseline|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
11290560|NCT02933476|FG000|Participant Flow|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
11332533|NCT03497026|BG000|Baseline|Robotic Bronchoscopy|"Robotic bronchoscopy with Robotic Bronchoscopy Platform~Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules."
11332534|NCT03497026|FG000|Participant Flow|Robotic Bronchoscopy|"Robotic bronchoscopy with Robotic Bronchoscopy Platform~Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules."
11332535|NCT03497026|OG000|Outcome|Robotic Bronchoscopy|"Robotic bronchoscopy with Robotic Bronchoscopy Platform~Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules."
11290561|NCT02933476|OG000|Outcome|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
11290562|NCT02933476|EG000|Reported Event|Vibrotactile Stimulation Treatment|"All patients will receive the vibrotactile stimulation treatment. No deception will be used.~Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device."
11290563|NCT02933489|BG000|Baseline|Arm A (DBT, AB-MR)|"Participants undergo DBT followed by AB-MR, for under 10 minutes, on the same day or within 24 hours at baseline and then after 1 year.~AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography"
11290564|NCT02933489|BG001|Baseline|Arm B (AB-MR, DBT)|"Participants undergo AB-MR, for under 10 minutes, followed by DBT on the same day or within 24 hours at baseline and then after 1 year.~AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography"
11290565|NCT02933489|BG002|Baseline|Total|Total of all reporting groups
11290566|NCT02933489|FG000|Participant Flow|Arm A (DBT, AB-MR)|"Participants undergo DBT followed by AB-MR, for under 10 minutes, on the same day or within 24 hours at baseline and then after 1 year.~AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography"
11290567|NCT02933489|FG001|Participant Flow|Arm B (AB-MR, DBT)|"Participants undergo AB-MR, for under 10 minutes, followed by DBT on the same day or within 24 hours at baseline and then after 1 year.~AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography"
11290568|NCT02933489|OG000|Outcome|Digital Breast Tomosynthesis (DBT)|"Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.~DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality"
11290569|NCT02933489|OG001|Outcome|Abbreviated Breast MR (AB-MR)|"Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.~DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality"
11290570|NCT02933489|OG000|Outcome|Test A: Digital Breast Tomography|Results of the Digital Breast Tomography (DBT) interpretation
11290571|NCT02933489|OG001|Outcome|Test B: Abbreviated MR|Results of the Abbreviated MR interpretation
11290572|NCT02933489|OG000|Outcome|Biopsy Recommended by Digital Breast Tomography|Patients with at least one lesion rated BI-RADS 4 or 5 on image interpretation.
11290573|NCT02933489|OG001|Outcome|Biopsy Recommended by AB-MR|Patients with at least one lesion rated BI-RADS 4 or 5 on Abbreviated MR interpretation.
11290574|NCT02933489|OG000|Outcome|DBT Additional Imaging Recommendation|subjects requiring further assessment by DBT (i.e. either a call back or short term follow up (STFU)) Call back is defined as having additional views or targeted ultrasound to evaluate DBT findings STFU is defined as having at least one lesion rated BI-RADS 3 on DBT Additional imaging recommendation is defined as having either call back or STFU
11290575|NCT02933489|OG001|Outcome|AB-MR Additional Imaging Recommendation|subjects requiring further assessment by AB-MR Call back does not apply to AB-MR and will not be evaluated Short Term Follow-up (STFU) is defined as having at least one lesion rated BI-RADS 3 on AB-MR Additional imaging recommendation is defined as having a STFU
11290576|NCT02933489|EG000|Reported Event|All Participants|All participants scheduled for both DBT and AB-MR Note, because of the temporal proximity (generally the same day), it is not possible to attribute the adverse events either by arm or by an individual modality.
11290577|NCT02933502|BG000|Baseline|DSXS Topical Product|"treatment with DSXS once daily for 28 days~DSXS topical product: treatment daily for 28 days"
11290578|NCT02933502|FG000|Participant Flow|DSXS Topical Product|"treatment with DSXS once daily for 28 days~DSXS topical product: treatment daily for 28 days"
11290579|NCT02933502|OG000|Outcome|DSXS Topical Product|"treatment with DSXS once daily for 28 days~DSXS topical product: treatment daily for 28 days"
11290580|NCT02933502|EG000|Reported Event|DSXS Topical Product|"treatment with DSXS once daily for 28 days~DSXS topical product: treatment daily for 28 days"
11290581|NCT02933528|BG000|Baseline|Dsxs Topical Product|"treatment with DSXS once daily for 28 days~DSXS Topical product: once daily for 28 days"
11290582|NCT02933528|FG000|Participant Flow|Dsxs Topical Product|"treatment with DSXS once daily for 28 days~DSXS Topical product: once daily for 28 days"
11290583|NCT02933528|OG000|Outcome|Dsxs Topical Product|"treatment with DSXS once daily for 28 days~DSXS Topical product: once daily for 28 days"
10842447|NCT00246441|BG001|Baseline|Placebo|"Placebo~Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."
10842448|NCT00246441|BG002|Baseline|Total|Total of all reporting groups
11290584|NCT02933528|EG000|Reported Event|Dsxs Topical Product|"treatment with DSXS once daily for 28 days~DSXS Topical product: once daily for 28 days"
11290585|NCT02933866|BG000|Baseline|DSXS Topical|"applied once daily for 28 days~DSXS topical: topical treatment"
10842449|NCT00246441|FG000|Participant Flow|Paroxetine|"Paroxetine~Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"
11290586|NCT02933866|BG001|Baseline|Vehicle Topical|"applied once daily for 28 days~Vehicle topical: topical treatment"
11290587|NCT02933866|BG002|Baseline|Total|Total of all reporting groups
11290588|NCT02933866|FG000|Participant Flow|DSXS Topical|"applied once daily for 28 days~DSXS topical: topical treatment"
11290589|NCT02933866|FG001|Participant Flow|Vehicle Topical|"applied once daily for 28 days~Vehicle topical: topical treatment"
11290590|NCT02933866|OG000|Outcome|DSXS Topical|"applied once daily for 28 days~DSXS topical: topical treatment"
11290591|NCT02933866|OG001|Outcome|Vehicle Topical|"applied once daily for 28 days~Vehicle topical: topical treatment"
11290592|NCT02933866|EG000|Reported Event|DSXS Topical|"applied once daily for 28 days~DSXS topical: topical treatment"
11290593|NCT02933866|EG001|Reported Event|Vehicle Topical|"applied once daily for 28 days~Vehicle topical: topical treatment"
11290594|NCT02933879|BG000|Baseline|NVXT Topical Treatment Group A|"daily dosing for one 8-week treatment period~NVXT topical: topical treatment"
11290595|NCT02933879|BG001|Baseline|NVXT Topical Treatment Group B|"daily dosing for two 8-week treatment periods separated by a 32-week rest period~NVXT topical: topical treatment"
11290596|NCT02933879|BG002|Baseline|Placebo (Vehicle) Topical Treatment Group C|"two 8-week treatment periods separated by a 32-week rest period~Placebo (Vehicle) Topical: Placebo (Vehicle) Topical"
11290597|NCT02933879|BG003|Baseline|Total|Total of all reporting groups
11290598|NCT02933879|FG000|Participant Flow|NVXT Topical Treatment Group A|"daily dosing for one 8-week treatment period~NVXT topical: topical treatment"
11290599|NCT02933879|FG001|Participant Flow|NVXT Topical Treatment Group B|"daily dosing for two 8-week treatment periods separated by a 32-week rest period~NVXT topical: topical treatment"
11290600|NCT02933879|FG002|Participant Flow|Placebo (Vehicle) Topical Treatment Group C|"two 8-week treatment periods separated by a 32-week rest period~Placebo (Vehicle) Topical: Placebo (Vehicle) Topical"
11290601|NCT02933879|OG000|Outcome|NVXT Topical Treatment Group A|"daily dosing for one 8-week treatment period~NVXT topical: topical treatment"
11290602|NCT02933879|OG001|Outcome|NVXT Topical Treatment Group B|"daily dosing for two 8-week treatment periods separated by a 32-week rest period~NVXT topical: topical treatment"
11290603|NCT02933879|OG002|Outcome|Placebo (Vehicle) Topical Treatment Group C|"two 8-week treatment periods separated by a 32-week rest period~Placebo (Vehicle) Topical: Placebo (Vehicle) Topical"
11290604|NCT02933879|OG000|Outcome|NVXT Topical Treatment Group A+B|"daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B),~NVXT topical: topical treatment"
11290605|NCT02933879|OG001|Outcome|Placebo (Vehicle) Topical Treatment Group C|"two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),~Placebo (Vehicle) Topical: Placebo (Vehicle) Topical"
11290606|NCT02933879|EG000|Reported Event|NVXT Topical Treatment Group A|"daily dosing for one 8-week treatment period~NVXT topical: topical treatment"
11290607|NCT02933879|EG001|Reported Event|NVXT Topical Treatment Group B|"daily dosing for two 8-week treatment periods separated by a 32-week rest period~NVXT topical: topical treatment"
11290608|NCT02933879|EG002|Reported Event|Placebo (Vehicle) Topical Treatment Group C|"two 8-week treatment periods separated by a 32-week rest period~Placebo (Vehicle) Topical: Placebo (Vehicle) Topical"
11290609|NCT02934178|BG000|Baseline|Cohort 1: WRSS1|Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
11290610|NCT02934178|BG001|Baseline|Cohort 1: Placebo|Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
11290611|NCT02934178|BG002|Baseline|Total|Total of all reporting groups
11290612|NCT02934178|FG000|Participant Flow|Cohort 1: WRSS1 3x10³ CFU|Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
11290613|NCT02934178|FG001|Participant Flow|Cohort 1: Placebo|Healthy toddlers received 3 oral doses of placebo to WRSS1 approximately 4 weeks apart.
11290614|NCT02934178|OG000|Outcome|Cohort 1: WRSS1|Healthy toddlers received 3 oral doses of 3x10³ CFU Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
11290615|NCT02934178|OG001|Outcome|Cohort 1: Placebo|Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
11290616|NCT02934178|OG000|Outcome|Cohort 1: WRSS1|Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
11290617|NCT02934178|EG000|Reported Event|Cohort 1: WRSS1|Healthy toddlers received 3 oral doses of 3x10³ colony-forming unit (CFU) Shigella sonnei strain WRSS1 vaccine approximately 4 weeks apart.
11290618|NCT02934178|EG001|Reported Event|Cohort 1: Placebo|Healthy toddlers received 3 oral doses of placebo to WRSS1 vaccine approximately 4 weeks apart.
11290619|NCT02934191|BG000|Baseline|Acetaminophen/Oxycodone + Celecoxib|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally"
11290620|NCT02934191|BG001|Baseline|Acetaminophen/Oxycodone + Placebo|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day."
11290621|NCT02934191|BG002|Baseline|Total|Total of all reporting groups
11290622|NCT02934191|FG000|Participant Flow|Acetaminophen/Oxycodone + Celecoxib|"Subjects will take acetaminophen orally in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally."
11290623|NCT02934191|FG001|Participant Flow|Acetaminophen/Oxycodone + Placebo|"Subjects will take acetaminophen orally in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day."
11290624|NCT02934191|OG000|Outcome|Acetaminophen/Oxycodone + Celecoxib|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally"
11290625|NCT02934191|OG001|Outcome|Acetaminophen/Oxycodone + Placebo|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day."
11290626|NCT02934191|EG000|Reported Event|Acetaminophen/Oxycodone + Celecoxib|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally"
11290627|NCT02934191|EG001|Reported Event|Acetaminophen/Oxycodone + Placebo|"Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.~Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day."
11290628|NCT02934347|BG000|Baseline|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
11290629|NCT02934347|BG001|Baseline|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
11290630|NCT02934347|BG002|Baseline|Total|Total of all reporting groups
11290631|NCT02934347|FG000|Participant Flow|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
11290632|NCT02934347|FG001|Participant Flow|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
11290633|NCT02934347|OG000|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
11290634|NCT02934347|OG001|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
10970907|NCT00912873|OG001|Outcome|0.4% Ropivicaine|"Patients will be given 0.4% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures.~0.4% Ropivacaine: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)"
10970908|NCT00912873|OG000|Outcome|0.1% Ropivicaine|ropivicaine 0.1% infusion at 12 mL/hour
10970909|NCT00912873|OG001|Outcome|0.4% Ropivicaine|ropivicaine 0.4% infusion at 3 mL/hour
10970910|NCT00912873|EG000|Reported Event|0.1% Ropivicaine|ropivicaine 0.1% infusion at 12 mL/hour
10970911|NCT00912873|EG001|Reported Event|0.4% Ropivicaine|ropivicaine 0.4% infusion at 3 mL/hour
10970912|NCT00912912|BG000|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
10970913|NCT00912912|FG000|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
11290635|NCT02934347|EG000|Reported Event|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
11290636|NCT02934347|EG001|Reported Event|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
11290637|NCT02934555|BG000|Baseline|Placebo|50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290638|NCT02934555|BG001|Baseline|Ubiquinol|300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290639|NCT02934555|BG002|Baseline|Total|Total of all reporting groups
11290640|NCT02934555|FG000|Participant Flow|Placebo|50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290641|NCT02934555|FG001|Participant Flow|Ubiquinol|300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290642|NCT02934555|OG000|Outcome|Placebo|50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290643|NCT02934555|OG001|Outcome|Ubiquinol|300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290644|NCT02934555|EG000|Reported Event|Placebo|50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290645|NCT02934555|EG001|Reported Event|Ubiquinol|300 mg of Ubiquinol mixed with 50 mL of Ensure (a dietary supplement) every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
11290646|NCT02934698|BG000|Baseline|Ivacaftor|"There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.~Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts."
11290647|NCT02934698|FG000|Participant Flow|Ivacaftor|"There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.~Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts."
11290648|NCT02934698|OG000|Outcome|Ivacaftor|"There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.~Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts."
11290649|NCT02934698|EG000|Reported Event|Ivacaftor|"There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.~Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts."
11290650|NCT02935036|BG000|Baseline|ADPS Topical Product|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~ADPS topical product: topical product"
11290651|NCT02935036|BG001|Baseline|Placebo Control|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~Placebo Control: topical product"
11290652|NCT02935036|BG002|Baseline|Total|Total of all reporting groups
11290653|NCT02935036|FG000|Participant Flow|ADPS Topical Product|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~ADPS topical product: topical product"
11290654|NCT02935036|FG001|Participant Flow|Placebo Control|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~Placebo Control: topical product"
11290655|NCT02935036|OG000|Outcome|ADPS Topical Product|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~ADPS topical product: topical product"
11290656|NCT02935036|OG001|Outcome|Placebo Control|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~Placebo Control: topical product"
11290657|NCT02935036|EG000|Reported Event|ADPS Topical Product|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~ADPS topical product: topical product"
11290658|NCT02935036|EG001|Reported Event|Placebo Control|"A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks~Placebo Control: topical product"
11290659|NCT02935062|BG000|Baseline|Software Phonological Therapy- SIFALA|"This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.~Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds."
11290660|NCT02935062|BG001|Baseline|Traditional Phonological Therapy- CYCLES|"This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.~Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words."
11290661|NCT02935062|BG002|Baseline|Placebo Therapy|"No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.~Placebo Therapy: No intervention to improve speech."
11290662|NCT02935062|BG003|Baseline|Total|Total of all reporting groups
11290663|NCT02935062|FG000|Participant Flow|Software Phonological Therapy- SIFALA|"This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.~Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds."
11290664|NCT02935062|FG001|Participant Flow|Traditional Phonological Therapy- CYCLES|"This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.~Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words."
11290665|NCT02935062|FG002|Participant Flow|Placebo Therapy|"No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.~Placebo Therapy: No intervention to improve speech."
11290666|NCT02935062|OG000|Outcome|Ciclos- Therapy|"This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.~Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words."
11290667|NCT02935062|OG001|Outcome|Software Phonological Therapy- SIFALA|"This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.~Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds."
11290668|NCT02935062|OG002|Outcome|Placebo Therapy|"No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.~Placebo Therapy: No intervention to improve speech."
11290669|NCT02935062|EG000|Reported Event|Software Phonological Therapy- SIFALA|"This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.~Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds."
11290670|NCT02935062|EG001|Reported Event|Traditional Phonological Therapy- CYCLES|"This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.~Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words."
11290671|NCT02935062|EG002|Reported Event|Placebo Therapy|"No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.~Placebo Therapy: No intervention to improve speech."
11290672|NCT02935088|BG000|Baseline|FFR-guided PCI Patients|Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who are undergoing fractional flow reserve (FFR)-guided Percutaneous intervention (PCI)
11290673|NCT02935088|FG000|Participant Flow|FFR-guided PCI Patients|Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who is undergoing Fractional flow reserve (FFR)-guided percutaneous intervention (PCI) procedure
11290674|NCT02935088|OG000|Outcome|FFR <= 0.80|Patients who had an FFR <= 0.80
11290675|NCT02935088|OG001|Outcome|FFR > 0.8|Patients who had an FFR > 0.80
11290676|NCT02935088|OG000|Outcome|FFR-guided PCI Patients (Lesion Level)|Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS). The analysis is performed on lesion level
11290677|NCT02935088|OG000|Outcome|FFR-guided PCI Patients|Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
11290678|NCT02935088|OG000|Outcome|Change in Treatment Plan Patients|The population who has a change in treatment plan post FFR
11290679|NCT02935088|OG001|Outcome|No Change in Treatment Plan Patients|The population who has no change in treatment plan post FFR
11290680|NCT02935088|OG000|Outcome|Pd/Pa ≤ 0.92|Patients who had an Pd/Pa ≤ 0.92
11290681|NCT02935088|OG001|Outcome|Pd/Pa > 0.92|Patients who had an Pd/Pa > 0.92
11290682|NCT02935088|EG000|Reported Event|FFR-guided PCI Patients|Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
11290683|NCT02935179|BG000|Baseline|Control Group|"Normal diet~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290684|NCT02935179|BG001|Baseline|Treatment Group|"Normal diet plus white sweet potato formula~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290685|NCT02935179|BG002|Baseline|Total|Total of all reporting groups
11290686|NCT02935179|FG000|Participant Flow|Control Group|"Normal diet~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290687|NCT02935179|FG001|Participant Flow|Treatment Group|"Normal diet plus white sweet potato formula~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290688|NCT02935179|OG000|Outcome|Control Group|"Normal diet~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290689|NCT02935179|OG001|Outcome|Treatment Group|"Normal diet plus white sweet potato formula~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290690|NCT02935179|EG000|Reported Event|Control Group|"Normal diet~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290691|NCT02935179|EG001|Reported Event|Treatment Group|"Normal diet plus white sweet potato formula~White sweet potato meal replacement: The formula were supplied 516 kcal daily"
11290692|NCT02935192|BG000|Baseline|Vaccine|"Seasonal trivalent split, inactivated influenza vaccine~Seasonal Influenza Vaccine: Seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B); 0.5 mL by IM injection"
11290693|NCT02935192|BG001|Baseline|Placebo|"Phosphate buffered saline~Phosphate Buffered Saline: Phosphate buffered saline, 0.5 mL by IM injection"
11290694|NCT02935192|BG002|Baseline|Total|Total of all reporting groups
11290695|NCT02935192|FG000|Participant Flow|Vaccine Arm|Trivalent seasonal influenza vaccine
11290696|NCT02935192|FG001|Participant Flow|Placebo Arm|Phosphate buffered saline
11290697|NCT02935192|OG000|Outcome|Vaccine Arm|Trivalent seasonal influenza vaccine
11290698|NCT02935192|OG001|Outcome|Placebo Arm|Phosphate buffered saline
11290699|NCT02935192|EG000|Reported Event|Vaccine|Trivalent seasonal influenza vaccine
11290700|NCT02935192|EG001|Reported Event|Placebo|Phosphate buffered saline
11290701|NCT02935452|BG000|Baseline|Genie|"This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.~GENIE - social networking tool: GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition."
10842450|NCT00246441|FG001|Participant Flow|Placebo|"Placebo~Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."
11290702|NCT02935452|BG001|Baseline|Normal Care|This group will have the same questionaires at discharge, but will be offered normal care
11290703|NCT02935452|BG002|Baseline|Total|Total of all reporting groups
11290704|NCT02935452|FG000|Participant Flow|Genie|"This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.~GENIE - social networking tool: GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition."
11290705|NCT02935452|FG001|Participant Flow|Normal Care|This group will have the same questionaires at discharge, but will be offered normal care
11290706|NCT02935452|OG000|Outcome|Genie|"This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.~GENIE - social networking tool: GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition."
11290707|NCT02935452|OG001|Outcome|Normal Care|This group will have the same questionaires at discharge, but will be offered normal care
11290708|NCT02935452|EG000|Reported Event|Genie|"This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.~GENIE - social networking tool: GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition."
11290709|NCT02935452|EG001|Reported Event|Normal Care|This group will have the same questionaires at discharge, but will be offered normal care
11290710|NCT02935543|BG000|Baseline|CART19|"CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.~CART 19: CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells"
11290711|NCT02935543|FG000|Participant Flow|CART19|"CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.~CART 19: CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells"
11290712|NCT02935543|OG000|Outcome|CART19|"CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.~CART 19: CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells"
11290713|NCT02935543|EG000|Reported Event|CART19|"CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.~CART 19: CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells"
11290714|NCT02935673|BG000|Baseline|Placebo|Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290715|NCT02935673|BG001|Baseline|750 mg LD / 250 mg MD Lumicitabine|Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290716|NCT02935673|BG002|Baseline|1000 mg LD / 500 mg MD Lumicitabine|Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290717|NCT02935673|BG003|Baseline|Total|Total of all reporting groups
11290718|NCT02935673|FG000|Participant Flow|Placebo|Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290719|NCT02935673|FG001|Participant Flow|750 mg LD / 250 mg MD Lumicitabine|Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290720|NCT02935673|FG002|Participant Flow|1000 mg LD / 500 mg MD Lumicitabine|Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290721|NCT02935673|OG000|Outcome|750 mg LD / 250 mg MD Lumicitabine|Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290722|NCT02935673|OG001|Outcome|1000 mg LD / 500 mg MD Lumicitabine|Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290723|NCT02935673|OG000|Outcome|Placebo|Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290724|NCT02935673|OG001|Outcome|750 mg LD / 250 mg MD Lumicitabine|Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290725|NCT02935673|OG002|Outcome|1000 mg LD / 500 mg MD Lumicitabine|Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290726|NCT02935673|EG000|Reported Event|Placebo|Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290727|NCT02935673|EG001|Reported Event|750 mg LD / 250 mg MD Lumicitabine|Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290728|NCT02935673|EG002|Reported Event|1000 mg LD / 500 mg MD Lumicitabine|Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
11290729|NCT02935699|BG000|Baseline|Test Drug|"JDP-205 Injection, 10 mg/mL, 1 mL~Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL"
11290730|NCT02935699|BG001|Baseline|Control|"Diphenhydramine Injection, 50 mg/mL, 1 mL~Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL"
11290731|NCT02935699|BG002|Baseline|Total|Total of all reporting groups
11290732|NCT02935699|FG000|Participant Flow|Test Drug|"JDP-205 Injection, 10 mg/mL, 1 mL~Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL"
11290733|NCT02935699|FG001|Participant Flow|Control|"Diphenhydramine Injection, 50 mg/mL, 1 mL~Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL"
11290734|NCT02935699|OG000|Outcome|Test Drug|"JDP-205 Injection, 10 mg/mL, 1 mL~Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL"
11290735|NCT02935699|OG001|Outcome|Control|"Diphenhydramine Injection, 50 mg/mL, 1 mL~Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL"
11290736|NCT02935699|EG000|Reported Event|Test Drug|"JDP-205 Injection, 10 mg/mL, 1 mL~Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL"
11290737|NCT02935699|EG001|Reported Event|Control|"Diphenhydramine Injection, 50 mg/mL, 1 mL~Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL"
11290738|NCT02935738|BG000|Baseline|The Clinical Data of Control Men Underwent IVF|
11290739|NCT02935738|BG001|Baseline|The Clinical Data of Treated Men Underwent IVF|
11290740|NCT02935738|BG002|Baseline|The Clinical Data of Control Men Underwent ICSI|
11290741|NCT02935738|BG003|Baseline|The Clinical Data of Treated Men Underwent ICSI|
11290742|NCT02935738|BG004|Baseline|Total|Total of all reporting groups
11290743|NCT02935738|FG000|Participant Flow|Prednisolone Treated Men / Positive SPA / IVF|Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (greater than five) were admitted to conventional in vitro fertilization (IVF) cycles.
11290744|NCT02935738|FG001|Participant Flow|Prednisolone Treated Men / Negative SPA / ICSI|"Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were admitted to intracytoplasmic sperm injection (ICSI) cycles.~Prednisolone treatment: Infertile men were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was"
11290745|NCT02935738|FG002|Participant Flow|Control Men / Positive SPA / IVF|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (more than five) were then admitted to in vitro fertilization (IVF) cycle.
11290746|NCT02935738|FG003|Participant Flow|Control Men / Negative SPA / ICSI|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were then admitted to intracytoplasmic sperm injection (ICSI) cycles.
11290747|NCT02935738|OG000|Outcome|Prednisolone Treated Men / Positive SPA / IVF|Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (greater than five) were admitted to conventional in vitro fertilization (IVF) cycles.
11290748|NCT02935738|OG001|Outcome|Prednisolone Treated Men / Negative SPA / ICSI|Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were admitted to intracytoplasmic sperm injection (ICSI) cycles.
11290749|NCT02935738|OG002|Outcome|Control Men / Positive SPA / IVF|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (more than five) were then admitted to in vitro fertilization (IVF) cycle.
11290750|NCT02935738|OG003|Outcome|Control Men / Negative SPA / ICSI|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were then admitted to intracytoplasmic sperm injection (ICSI) cycles.
11290751|NCT02935738|EG000|Reported Event|Prednisolone Treated Men / Positive SPA / IVF|Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (greater than five) were admitted to conventional in vitro fertilization (IVF) cycles.
10822197|NCT00075218|FG001|Participant Flow|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
10842451|NCT00246441|OG000|Outcome|Paroxetine|"Paroxetine~Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"
11290752|NCT02935738|EG001|Reported Event|Prednisolone Treated Men / Negative SPA / ICSI|Infertile men, with anti-sperm antibodies, were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were admitted to intracytoplasmic sperm injection (ICSI) cycles.
11290753|NCT02935738|EG002|Reported Event|Control Men / Positive SPA / IVF|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (more than five) were then admitted to in vitro fertilization (IVF) cycle.
11290754|NCT02935738|EG003|Reported Event|Control Men / Negative SPA / ICSI|Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were then admitted to intracytoplasmic sperm injection (ICSI) cycles.
11290755|NCT02935842|BG000|Baseline|rSLT, Then no Therapy, Then rBMT|"Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.~Then participants could be allocated to the no-therapy group, and after 6-month completion again into the rBMT intervention."
11290756|NCT02935842|BG001|Baseline|rBMT, Then rSLT, Then no Therapy|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.~Then participants could be enrolled in the rSLT group, and after 6-month completion again into the 'no-therapy' group."
11290757|NCT02935842|BG002|Baseline|No Therapy, Then rSLT or rBMT, Then rBMT or rSLT|"the 6-months-waiting list. PD patients who had to wait for/ or chose to receive treatments at a later time.~After 6-month completion, participants could enrol in the rSLT or the rBMT intervention program, and then upon 6-month completion again in the opposite intervention program, being rBMT or rSLT, respectively."
11290758|NCT02935842|BG003|Baseline|Healthy Controls; no Therapy|Healthy Controls received no therapy.
11290759|NCT02935842|BG004|Baseline|Total|Total of all reporting groups
11290760|NCT02935842|FG000|Participant Flow|rSLT, Then no Therapy, Then rBMT|"Specific, intensive and high-frequency speech-language-therapy (rSLT). Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.~Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6 months 'no therapy' period, the participant could enrol again into the 'rhythmic balance-movement training'' rBMT)."
11290761|NCT02935842|FG001|Participant Flow|rBMT, Then 'no Therapy', Then rSLT|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.~Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6-months period as 'no therapy', the participant could switch to the 'rhythmic speech-language therapy' group (rSLT)."
11290762|NCT02935842|FG002|Participant Flow|No Therapy, Then rSLT, Then rBMT|"the 6-months-waiting list. Patients with Parkinson's disease (PD) who had to wait for/ or chose to receive treatments at a later time.~Please note: this was a case-crossover study. After completing the 6-month waiting list (no therapy), participants had then the opportunity to switch to another study arm (being 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training' (rBMT). After having completed the second intervention program, the participant could enrol again into a study arm, which he/she has not been before (i.e. either 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training'' rBMT)."
11290763|NCT02935842|FG003|Participant Flow|Healthy Controls; no Therapy|Healthy Controls received no therapy.
11290764|NCT02935842|OG000|Outcome|Specific SL-therapy for PD-DBS and Non-DBS|"Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total."
11290765|NCT02935842|OG001|Outcome|rBMT for PD-DBS and Non-DBS|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total."
11290766|NCT02935842|OG002|Outcome|PD-DBS/ Non-DBS; no Therapy|"the 6-months-waiting list. PD patients who had to wait for/ or chose to receive treatments at a later time."
11290767|NCT02935842|OG003|Outcome|Healthy Controls; no Therapy|Healthy Controls received no therapy.
11290768|NCT02935842|OG000|Outcome|Specific SL-therapy for PD (With and Without DBS)|"Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total."
10822198|NCT00075218|FG002|Participant Flow|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
11290769|NCT02935842|OG001|Outcome|rBMT for PD (With and Without DBS)|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total."
11290770|NCT02935842|OG002|Outcome|PD (With and Without DBS); no Therapy|No further recruiting necessary, as data is already at hand via previous research projects.
11290771|NCT02935842|OG003|Outcome|Healthy Controls; no Therapy|No further recruiting necessary, as data is already at hand via previous research projects.
11290772|NCT02935842|OG000|Outcome|rSLT, Then no Therapy, Then rBMT|"Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.~Then participants could be allocated to the no-therapy group, and after 6-month completion again into the rBMT intervention."
11290773|NCT02935842|OG001|Outcome|rBMT, Then rSLT, Then no Therapy|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.~Then participants could be enrolled in the rSLT group, and after 6-month completion again into the 'no-therapy' group."
11290774|NCT02935842|OG002|Outcome|No Therapy, Then rSLT or rBMT, Then rBMT or rSLT|"the 6-months-waiting list. PD patients who had to wait for/ or chose to receive treatments at a later time.~After 6-month completion, participants could enrol in the rSLT or the rBMT intervention program, and then upon 6-month completion again in the opposite intervention program, being rBMT or rSLT, respectively."
11290775|NCT02935842|EG000|Reported Event|Specific SL-therapy for PD-DBS and Non-DBS|"Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks~Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total."
11290776|NCT02935842|EG001|Reported Event|rBMT for PD-DBS and Non-DBS|"Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks~Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total."
11290777|NCT02935842|EG002|Reported Event|PD-DBS/ Non-DBS; no Therapy|"the 6-months-waiting list. PD patients who had to wait for/ or chose to receive treatments at a later time."
11290778|NCT02935842|EG003|Reported Event|Healthy Controls; no Therapy|Healthy Controls received no therapy.
11290779|NCT02935894|BG000|Baseline|Single Group|"All subjects will participate in 4 study day visits in the same order.~compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise on a stationary bicycle).~compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee).~collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist).~collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.~Ibuprofen: 400 mg ibuprofen given to inhibit cyclooxygenase (COX) metabolism~Physiological induction of sweating: 15 minutes exercise at 60-80% oxygen consumption to induce sweating~Pilocarpine: Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a"
11290780|NCT02935894|FG000|Participant Flow|Single Group|"Subjects will participate in 4 study visits in the same order.~compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle).~compare sweat collected following stimulation of sweating by pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee).~collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist).~collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.~Ibuprofen: 400 mg ibuprofen given to inhibit cyclooxygenase metabolism~Physiological induction of sweating: 15 minutes exercise at 60-80% oxygen consumption to induce sweating~Pilocarpine: Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine"
11290781|NCT02935894|OG000|Outcome|Single Group|"All subjects will participate in 4 study day visits in the same order.~compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle).~compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee).~collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist).~collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.~Ibuprofen: 400 mg ibuprofen given to inhibit COX metabolism~Physiological induction of sweating: 15 minutes exercise at 60-80% oxygen consumption to induce sweating~Pilocarpine: Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine"
11290782|NCT02935894|EG000|Reported Event|Single Group|"All subjects will participate in 4 study day visits in the same order.~compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle).~compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee).~collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist).~collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.~Ibuprofen: 400 mg ibuprofen given to inhibit COX metabolism~Physiological induction of sweating: 15 minutes exercise at 60-80% oxygen consumption to induce sweating~Pilocarpine: Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine"
11290783|NCT02936037|BG000|Baseline|Placebo|"Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~PLACEBO: an inactive substance"
10970914|NCT00912912|OG000|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
11290784|NCT02936037|BG001|Baseline|MD1003|"MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~MD1003 100mg capsule"
11290785|NCT02936037|BG002|Baseline|Total|Total of all reporting groups
11290786|NCT02936037|FG000|Participant Flow|Placebo|"Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~PLACEBO: an inactive substance"
11290787|NCT02936037|FG001|Participant Flow|MD1003|"MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~MD1003 100mg capsule"
11290788|NCT02936037|OG000|Outcome|Placebo|"Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~PLACEBO: an inactive substance"
11290789|NCT02936037|OG001|Outcome|MD1003|"MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~MD1003 100mg capsule"
11290790|NCT02936037|EG000|Reported Event|GROUP 1|"Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~PLACEBO: an inactive substance"
11290791|NCT02936037|EG001|Reported Event|GROUP 2|"MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.~MD1003 100mg capsule"
11290792|NCT02936076|BG000|Baseline|Exercise Condition|"Participants randomized to the exercise condition will participate in a 12-week exercise training program. The exercise intervention will consist of both supervised and unsupervised exercise sessions and progress to 200 minutes/week of moderate-intensity exercise. Exercise bouts will be spread across 4-6 days and be at least 20 minutes in duration. During supervised visits, heart rate will be monitored by a member of the research staff to ensure that exercise is within the prescribed intensity range and ratings of perceived exertion and feeling state will be assessed periodically. Unsupervised exercise will be verified using objective physical activity monitors.~Exercise intervention"
11290793|NCT02936076|BG001|Baseline|Delayed Exercise Condition|"Participants randomized to the delayed exercise condition will be asked not to change their exercise or eating habits over the 12-week period and will complete the same assessment measures as the exercise condition. However, following the completion of the 12-week period, participants will be given two options: 1) receive a one-on-one session with an exercise physiologist at our center and receive a written exercise program, and at this time point all study obligations will be completed, or 2) complete the identical exercise protocol as the 'exercise' condition.~Delayed exercise intervention"
11290794|NCT02936076|BG002|Baseline|Total|Total of all reporting groups
11290795|NCT02936076|FG000|Participant Flow|Exercise Condition|"Participants randomized to the exercise condition will participate in a 12-week exercise training program. The exercise intervention will consist of both supervised and unsupervised exercise sessions and progress to 200 minutes/week of moderate-intensity exercise. Exercise bouts will be spread across 4-6 days and be at least 20 minutes in duration. During supervised visits, heart rate will be monitored by a member of the research staff to ensure that exercise is within the prescribed intensity range and ratings of perceived exertion and feeling state will be assessed periodically. Unsupervised exercise will be verified using objective physical activity monitors.~Exercise intervention"
11290796|NCT02936076|FG001|Participant Flow|Delayed Exercise Condition|"Participants randomized to the delayed exercise condition will be asked not to change their exercise or eating habits over the 12-week period and will complete the same assessment measures as the exercise condition. However, following the completion of the 12-week period, participants will be given two options: 1) receive a one-on-one session with an exercise physiologist at our center and receive a written exercise program, and at this time point all study obligations will be completed, or 2) complete the identical exercise protocol as the 'exercise' condition.~Delayed exercise intervention"
11290797|NCT02936076|OG000|Outcome|Exercise Condition|"Participants randomized to the exercise condition will participate in a 12-week exercise training program. The exercise intervention will consist of both supervised and unsupervised exercise sessions and progress to 200 minutes/week of moderate-intensity exercise. Exercise bouts will be spread across 4-6 days and be at least 20 minutes in duration. During supervised visits, heart rate will be monitored by a member of the research staff to ensure that exercise is within the prescribed intensity range and ratings of perceived exertion and feeling state will be assessed periodically. Unsupervised exercise will be verified using objective physical activity monitors.~Exercise intervention"
11290798|NCT02936076|OG001|Outcome|Delayed Exercise Condition|"Participants randomized to the delayed exercise condition will be asked not to change their exercise or eating habits over the 12-week period and will complete the same assessment measures as the exercise condition. However, following the completion of the 12-week period, participants will be given two options: 1) receive a one-on-one session with an exercise physiologist at our center and receive a written exercise program, and at this time point all study obligations will be completed, or 2) complete the identical exercise protocol as the 'exercise' condition.~Delayed exercise intervention"
11290799|NCT02936076|EG000|Reported Event|Exercise Condition|"Participants randomized to the exercise condition will participate in a 12-week exercise training program. The exercise intervention will consist of both supervised and unsupervised exercise sessions and progress to 200 minutes/week of moderate-intensity exercise. Exercise bouts will be spread across 4-6 days and be at least 20 minutes in duration. During supervised visits, heart rate will be monitored by a member of the research staff to ensure that exercise is within the prescribed intensity range and ratings of perceived exertion and feeling state will be assessed periodically. Unsupervised exercise will be verified using objective physical activity monitors.~Exercise intervention"
11290800|NCT02936076|EG001|Reported Event|Delayed Exercise Condition|"Participants randomized to the delayed exercise condition will be asked not to change their exercise or eating habits over the 12-week period and will complete the same assessment measures as the exercise condition. However, following the completion of the 12-week period, participants will be given two options: 1) receive a one-on-one session with an exercise physiologist at our center and receive a written exercise program, and at this time point all study obligations will be completed, or 2) complete the identical exercise protocol as the 'exercise' condition.~Delayed exercise intervention"
11290801|NCT02936479|BG000|Baseline|Berinert Treatment|C1-INH (Berinert)
10970915|NCT00912912|EG000|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
11290802|NCT02936479|FG000|Participant Flow|Berinert Treatment|C1-Inhibitor (INH) (Berinert): C1 esterase inhibitor, Berinert, 25-50 units/kg, intravenous, 7 doses on days 1, 3, 5, 7, 9, 11, 13 and 50 units/kg twice weekly for a total study period of 6 months.
11290803|NCT02936479|OG000|Outcome|Berinert Treatment|C1-INH (Berinert)
11290804|NCT02936479|EG000|Reported Event|Berinert Treatment|C1-INH (Berinert)
11290805|NCT02936635|BG000|Baseline|Delayed Start Treatment|The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
11290806|NCT02936635|BG001|Baseline|Early Start Treatment|The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
11290807|NCT02936635|BG002|Baseline|Total|Total of all reporting groups
11290808|NCT02936635|FG000|Participant Flow|Delayed Start Treatment|The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
11290809|NCT02936635|FG001|Participant Flow|Early Start Treatment|The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
11290810|NCT02936635|OG000|Outcome|Delayed Start Treatment|The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
11290811|NCT02936635|OG001|Outcome|Early Start Treatment|The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
11290812|NCT02936635|EG000|Reported Event|Delayed Start Treatment|The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
11290813|NCT02936635|EG001|Reported Event|Early Start Treatment|The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
11290814|NCT02936648|BG000|Baseline|Baseline Characteristics at Intervention Sites|QI Intervention. QI: HCV Testing QI. Baseline characteristics at intervention sites, pre-implementation.
11290815|NCT02936648|FG000|Participant Flow|Quality Improvement Intervention|"quality improvement Intervention~quality improvement : HCV Testing quality improvement"
11290816|NCT02936648|OG000|Outcome|Quality Improvement Intervention|"QI Intervention~QI: HCV Testing QI"
11290817|NCT02936648|EG000|Reported Event|HCV Testing QI|Intervention/HCV Testing QI: lean and facilitation implementation to increase HCV testing
11290818|NCT02936869|BG000|Baseline|Control Arm|Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
11290819|NCT02936869|BG001|Baseline|Referral Incentive Arm|"Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.~Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.~Performance-based monetary incentives"
11290820|NCT02936869|BG002|Baseline|Total|Total of all reporting groups
11290821|NCT02936869|FG000|Participant Flow|Control Arm|Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
11290822|NCT02936869|FG001|Participant Flow|Referral Incentive Arm|"Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.~Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.~Performance-based monetary incentives"
11290823|NCT02936869|OG000|Outcome|Control Arm|Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
11290824|NCT02936869|OG001|Outcome|Referral Incentive Arm|"Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.~Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.~Performance-based monetary incentives"
10822199|NCT00075218|OG000|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
10822200|NCT00075218|OG001|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
10822201|NCT00075218|EG000|Reported Event|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
10842452|NCT00246441|OG001|Outcome|Placebo|"Placebo~Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."
11290825|NCT02936869|OG001|Outcome|Referral Incentive Arm|"Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.~Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of maternal delivery clients to postnatal care within 48 hours of delivery in a facility if verified.~Performance-based monetary incentives"
11290826|NCT02936869|EG000|Reported Event|Control Arm|Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
11290827|NCT02936869|EG001|Reported Event|Referral Incentive Arm|"Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.~Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.~Performance-based monetary incentives"
11290828|NCT02937116|BG000|Baseline|Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)|1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
10970916|NCT00912925|BG000|Baseline|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970917|NCT00912925|BG001|Baseline|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970918|NCT00912925|BG002|Baseline|Total|Total of all reporting groups
10970919|NCT00912925|FG000|Participant Flow|Placebo|Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970920|NCT00912925|FG001|Participant Flow|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970921|NCT00912925|OG000|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970922|NCT00912925|OG001|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
10970923|NCT00912925|EG000|Reported Event|Placebo***Check Title***|Placebo***Check Description***
10970924|NCT00912925|EG001|Reported Event|Aldurazyme***Check Title***|Aldurazyme***Check Description***
11290829|NCT02937116|BG001|Baseline|Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)|3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290830|NCT02937116|BG002|Baseline|Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)|10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290831|NCT02937116|BG003|Baseline|Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)|200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
11290832|NCT02937116|BG004|Baseline|MEL: Sintilimab 200mg Q3W (Cohort A)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290833|NCT02937116|BG005|Baseline|Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
10970925|NCT00912964|BG000|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
10970926|NCT00912964|BG001|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
10970927|NCT00912964|BG002|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
10970928|NCT00912964|BG003|Baseline|Total|Total of all reporting groups
10970929|NCT00912964|FG000|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
10970930|NCT00912964|FG001|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
10970931|NCT00912964|FG002|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
10970932|NCT00912964|OG000|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
10970933|NCT00912964|OG001|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
10970934|NCT00912964|OG002|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
10970935|NCT00912964|EG000|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
10970936|NCT00912964|EG001|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
10970937|NCT00912964|EG002|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
11290834|NCT02937116|BG006|Baseline|NSCLC: Sintilimab 200mg Q3W (Cohort C)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290835|NCT02937116|BG007|Baseline|nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)|Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290836|NCT02937116|BG008|Baseline|scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)|Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290837|NCT02937116|BG009|Baseline|Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)|Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11336297|NCT03565068|OG013|Outcome|Panel B (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
11290838|NCT02937116|BG010|Baseline|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)|Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290839|NCT02937116|BG011|Baseline|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)|Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290840|NCT02937116|BG012|Baseline|Total|Total of all reporting groups
11290841|NCT02937116|FG000|Participant Flow|Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)|1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290842|NCT02937116|FG001|Participant Flow|Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)|3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290843|NCT02937116|FG002|Participant Flow|Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)|10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290844|NCT02937116|FG003|Participant Flow|Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)|200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
11290845|NCT02937116|FG004|Participant Flow|MEL: Sintilimab 200mg Q3W (Cohort A)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290846|NCT02937116|FG005|Participant Flow|Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290847|NCT02937116|FG006|Participant Flow|NSCLC: Sintilimab 200mg Q3W (Cohort C)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290848|NCT02937116|FG007|Participant Flow|nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)|Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290849|NCT02937116|FG008|Participant Flow|scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)|Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290850|NCT02937116|FG009|Participant Flow|Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)|Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290851|NCT02937116|FG010|Participant Flow|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)|Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290852|NCT02937116|FG011|Participant Flow|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)|Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290853|NCT02937116|OG000|Outcome|Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)|1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290854|NCT02937116|OG001|Outcome|Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)|3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290855|NCT02937116|OG002|Outcome|Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)|10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290856|NCT02937116|OG003|Outcome|Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)|200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
11290857|NCT02937116|OG004|Outcome|MEL: Sintilimab 200mg Q3W (Cohort A)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290858|NCT02937116|OG005|Outcome|Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290859|NCT02937116|OG006|Outcome|NSCLC: Sintilimab 200mg Q3W (Cohort C)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
10842453|NCT00246441|EG000|Reported Event|Paroxetine|"Paroxetine~Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"
11290860|NCT02937116|OG007|Outcome|nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)|Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290861|NCT02937116|OG008|Outcome|scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)|Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290862|NCT02937116|OG009|Outcome|Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)|Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290863|NCT02937116|OG010|Outcome|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)|Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290864|NCT02937116|OG011|Outcome|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)|Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290865|NCT02937116|EG000|Reported Event|Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)|1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290866|NCT02937116|EG001|Reported Event|Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)|3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290867|NCT02937116|EG002|Reported Event|Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)|10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
11290868|NCT02937116|EG003|Reported Event|Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)|200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
11290869|NCT02937116|EG004|Reported Event|MEL: Sintilimab 200mg Q3W (Cohort A)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290870|NCT02937116|EG005|Reported Event|Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290871|NCT02937116|EG006|Reported Event|NSCLC: Sintilimab 200mg Q3W (Cohort C)|Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290872|NCT02937116|EG007|Reported Event|nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)|Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290873|NCT02937116|EG008|Reported Event|scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)|Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290874|NCT02937116|EG009|Reported Event|Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)|Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290875|NCT02937116|EG010|Reported Event|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)|Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290876|NCT02937116|EG011|Reported Event|Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)|Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
11290877|NCT02937168|BG000|Baseline|Part 1: PET/CT Scan|Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
11290878|NCT02937168|FG000|Participant Flow|Part 1: PET/CT Scan|Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received Fluorodeoxyglucose F-18 (FDG) as part of the PET/CT procedures and provided sputum/blood samples.
11290879|NCT02937168|FG001|Participant Flow|Part 2: Reslizumab|Reslizumab 3.0 milligrams/kilogram (mg/kg) was planned to be administered by intravenous (IV) infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
11290880|NCT02937168|FG002|Participant Flow|Part 2: Placebo|Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
11290881|NCT02937168|OG000|Outcome|Part 1: PET/CT Scan|Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
11290882|NCT02937168|OG000|Outcome|Part 2: Reslizumab|Reslizumab 3.0 mg/kg was planned to be administered by IV infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
11290883|NCT02937168|OG001|Outcome|Part 2: Placebo|Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
11290884|NCT02937168|EG000|Reported Event|Part 1: PET/CT Scan|Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
11290885|NCT02937194|BG000|Baseline|Personal Oral Health Instruction + Pamphlets Distribution|"Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.~Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"
11290886|NCT02937194|BG001|Baseline|Pamphlets Distribution|"Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.~Pamphlets distribution: Oral health pamphlets distribution"
11290887|NCT02937194|BG002|Baseline|Total|Total of all reporting groups
11332536|NCT03497026|EG000|Reported Event|Robotic Bronchoscopy|"Robotic bronchoscopy with Robotic Bronchoscopy Platform~Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules."
11335791|NCT03557034|BG000|Baseline|Standard of Care Monitoring|"Standard of Care~This is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."
11290888|NCT02937194|FG000|Participant Flow|Personal Oral Health Instruction + Pamphlets Distribution|"Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.~Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"
11290889|NCT02937194|FG001|Participant Flow|Pamphlets Distribution|"Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.~Pamphlets distribution: Oral health pamphlets distribution"
11290890|NCT02937194|OG000|Outcome|Personal Oral Health Instruction + Pamphlets Distribution|"Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.~Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"
11290891|NCT02937194|OG001|Outcome|Pamphlets Distribution|"Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.~Pamphlets distribution: Oral health pamphlets distribution"
11290892|NCT02937194|EG000|Reported Event|Personal Oral Health Instruction + Pamphlets Distribution|"Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.~Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"
11290893|NCT02937194|EG001|Reported Event|Pamphlets Distribution|"Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.~Pamphlets distribution: Oral health pamphlets distribution"
11290894|NCT02937350|BG000|Baseline|Healthy Controls|Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2)
11290895|NCT02937350|BG001|Baseline|CKD Group|CKD group defined as those with eGFR <60ml/min per 1.73 m2)
10842454|NCT00246441|EG001|Reported Event|Placebo|"Placebo~Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."
10842455|NCT00246519|BG000|Baseline|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
11290896|NCT02937350|BG002|Baseline|Kidney Failure Group|Kidney failure group defined as those with ESKD treated with dialysis
11290897|NCT02937350|BG003|Baseline|Total|Total of all reporting groups
11290898|NCT02937350|FG000|Participant Flow|Healthy Controls|Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2)
11290899|NCT02937350|FG001|Participant Flow|CKD Group|CKD group defined as those with eGFR <60ml/min per 1.73 m2)
11290900|NCT02937350|FG002|Participant Flow|Kidney Failure Group|Kidney failure group defined as those with ESKD treated with dialysis
11290901|NCT02937350|OG000|Outcome|Healthy Controls|Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2)
11290902|NCT02937350|OG001|Outcome|CKD Group|CKD group defined as those with eGFR <60ml/min per 1.73 m2)
11290903|NCT02937350|OG002|Outcome|Kidney Failure Group|Kidney failure group defined as those with ESKD treated with dialysis
11290904|NCT02937350|EG000|Reported Event|All Participants|All participants (N=87)
11290905|NCT02937454|BG000|Baseline|FCM (Ferric Carboxymaltose)|"Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates."
11290906|NCT02937454|BG001|Baseline|Placebo (Normal Saline (NaCl 0.9%))|"Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates."
11290907|NCT02937454|BG002|Baseline|Total|Total of all reporting groups
11290908|NCT02937454|FG000|Participant Flow|FCM (Ferric Carboxymaltose)|"Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates."
11290909|NCT02937454|FG001|Participant Flow|Placebo (Normal Saline (NaCl 0.9%))|"Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates."
11290910|NCT02937454|OG000|Outcome|FCM (Ferric Carboxymaltose)|"Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates."
10822202|NCT00075218|EG001|Reported Event|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
11336298|NCT03565068|OG014|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11336299|NCT03565068|OG015|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg|In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
11336300|NCT03565068|OG016|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336301|NCT03565068|OG017|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11336302|NCT03565068|OG018|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11336303|NCT03565068|OG019|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11336304|NCT03565068|OG020|Outcome|Panel C (Schizophrenia Participants): Placebo Add-on Therapy|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
11336305|NCT03565068|OG021|Outcome|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11336306|NCT03565068|OG022|Outcome|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
11336307|NCT03565068|OG023|Outcome|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336308|NCT03565068|OG024|Outcome|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11336309|NCT03565068|OG025|Outcome|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11336310|NCT03565068|OG026|Outcome|Panel D (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
11336311|NCT03565068|OG015|Outcome|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
11336312|NCT03565068|EG000|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11336313|NCT03565068|EG001|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
11336314|NCT03565068|EG002|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336315|NCT03565068|EG003|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11336316|NCT03565068|EG004|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11336317|NCT03565068|EG005|Reported Event|Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg|Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11336318|NCT03565068|EG006|Reported Event|Panel A (Healthy Participants): Placebo Monotherapy|Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
11336319|NCT03565068|EG007|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11290911|NCT02937454|OG001|Outcome|Placebo (Normal Saline (NaCl 0.9%))|"Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates."
11290912|NCT02937454|OG000|Outcome|FCM (Ferric Carboxymaltose)|"Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates"
11290913|NCT02937454|EG000|Reported Event|Group 1 - FCM (Ferric Carboxymaltose)|"Ferric carboxymaltose (FCM), administered by bolus IV injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the subject's body weight and Hb level.~From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the subject's Hb levels measured prior to planned dosing dates."
11290914|NCT02937454|EG001|Reported Event|Group 2 - Placebo (Normal Saline (NaCl 0.9%))|Normal saline (NaCl 0.9%), administered by bolus IV injection at a volume corresponding to the FCM dose determined by the subject's body weight and Hb level (i.e., 10 ml or 20 ml per administration).
11290915|NCT02937506|BG000|Baseline|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
11290916|NCT02937506|BG001|Baseline|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
11290917|NCT02937506|BG002|Baseline|Total|Total of all reporting groups
11290918|NCT02937506|FG000|Participant Flow|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
11290919|NCT02937506|FG001|Participant Flow|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
11290920|NCT02937506|OG000|Outcome|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
11290921|NCT02937506|OG001|Outcome|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
11290922|NCT02937506|EG000|Reported Event|Propofol|"Patients in the treatment arm will be given propofol only when having a colonoscopy.~Propofol: The intervention is to use propofol as anesthesia during a colonoscopy."
11290923|NCT02937506|EG001|Reported Event|Fentanyl Plus Midazolam Only|"Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.~Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy."
11290924|NCT02937545|BG000|Baseline|PGx Only (Patients)|"Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.~Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing."
11290925|NCT02937545|BG001|Baseline|PGx + MTM (Patients)|"Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results.~Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing~Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing."
11290926|NCT02937545|BG002|Baseline|Total|Total of all reporting groups
11290927|NCT02937545|FG000|Participant Flow|PGx Only (Patients)|Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
11290928|NCT02937545|FG001|Participant Flow|PGx + MTM (Patients)|"Patients received pharmacogenetic testing along with medication therapy management (MTM). Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists made recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Data collected from both patients and pharmacists.~Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing"
11290929|NCT02937545|FG002|Participant Flow|PGx Only (Pharmacists)|Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
11290930|NCT02937545|FG003|Participant Flow|PGx + MTM (Pharmacists)|Patients received pharmacogenetic testing plus medication therapy management (MTM). Participating pharmacist made recommendations for drug/dose changes based on PGx results and conducted MTM. Data collected from both patients and pharmacists.
11290931|NCT02937545|OG000|Outcome|PGx Only (Patients)|Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
11290932|NCT02937545|OG001|Outcome|PGx + MTM (Patients)|Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
11290933|NCT02937545|OG000|Outcome|PGx Only (Pharmacists)|Pharmacists delivered PGx only tests to eligible/consented patients
11290934|NCT02937545|OG001|Outcome|PGx + MTM (Pharmacists)|Pharmacists delivered PGx testing with MTM to eligible/consented patients
11290935|NCT02937545|OG001|Outcome|PGx Plus MTM (Pharmacists)|Pharmacists delivered PGx testing with MTM to eligible/consented patients
11290936|NCT02937545|EG000|Reported Event|PGx Only (Patients)|"Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.~Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing."
11290937|NCT02937545|EG001|Reported Event|PGx + MTM (Patients)|"Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results.~Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing~Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing."
11290938|NCT02937545|EG002|Reported Event|PGx Only (Pharmacists)|Participating pharmacists provided participating patients with pharmacogenetic testing only
11290939|NCT02937545|EG003|Reported Event|PGx + MTM (Pharmacists)|Participating pharmacists provided participating patients with pharmacogenetic testing along with medication therapy management (MTM)
11290940|NCT02937558|BG000|Baseline|CSI-Glucagon|"Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.~Glucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide"
11290941|NCT02937558|BG001|Baseline|Placebo|"Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.~Placebo: Isotonic saline"
11290942|NCT02937558|BG002|Baseline|Total|Total of all reporting groups
11290943|NCT02937558|FG000|Participant Flow|CSI-Glucagon|"Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.~Glucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide"
11290944|NCT02937558|FG001|Participant Flow|Placebo|"Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.~Placebo: Isotonic saline"
11290945|NCT02937558|OG000|Outcome|CSI-Glucagon|"Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.~Glucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide"
11290946|NCT02937558|OG001|Outcome|Placebo|"Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.~Placebo: Isotonic saline"
11290947|NCT02937558|EG000|Reported Event|CSI-Glucagon (Double-Blind)|"Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.~Glucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide"
11290948|NCT02937558|EG001|Reported Event|Placebo|"Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.~Placebo: Isotonic saline"
11290949|NCT02937558|EG002|Reported Event|CSI-Glucagon (Open-Label)|"Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.~Glucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide"
11290950|NCT02937584|BG000|Baseline|Overall Study|ITT Population
11290951|NCT02937584|FG000|Participant Flow|GP MDI/ FF MDI|Glycopyrronium Metered Dose Inhalation /Formoterol Fumarate Metered Dose Inhalation
11290952|NCT02937584|FG001|Participant Flow|FF MDI/GP MDI|Formoterol Fumarate Metered Dose Inhalation / Glycopyrronium Metered Dose Inhalation
11290953|NCT02937584|OG000|Outcome|GP MDI|Glycopyrronium Metered Dose Inhalation
11290954|NCT02937584|OG001|Outcome|FF MDI|FF MDI Formoterol Fumarate Metered Dose Inhalation
11290955|NCT02937584|EG000|Reported Event|GP MDI|Glycopyrronium Metered Dose Inhalation
11290956|NCT02937584|EG001|Reported Event|FF MDI|FF MDI Formoterol Fumarate Metered Dose Inhalation
11290957|NCT02937623|BG000|Baseline|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
11290958|NCT02937623|BG001|Baseline|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
11290959|NCT02937623|BG002|Baseline|Total|Total of all reporting groups
11290960|NCT02937623|FG000|Participant Flow|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
11290961|NCT02937623|FG001|Participant Flow|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
11290962|NCT02937623|OG000|Outcome|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
11290963|NCT02937623|OG001|Outcome|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
11290964|NCT02937623|EG000|Reported Event|Test Product: Dissolvable Polymer Strip Containing Novamin|In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
11290965|NCT02937623|EG001|Reported Event|Reference Product: No Treatment/Product|In this arm, participants did not receive any treatment/product.
11336320|NCT03565068|EG008|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
11290966|NCT02937636|BG000|Baseline|Test Product|Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290967|NCT02937636|BG001|Baseline|Reference Product|Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290968|NCT02937636|BG002|Baseline|Total|Total of all reporting groups
11290969|NCT02937636|FG000|Participant Flow|Test Product|Participants applied a full strip of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 parts per million (ppm) fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290970|NCT02937636|FG001|Participant Flow|Reference Product|Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290971|NCT02937636|OG000|Outcome|Test Product|Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290972|NCT02937636|OG001|Outcome|Reference Product|Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290973|NCT02937636|OG000|Outcome|Test Product|Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine
11290974|NCT02937636|EG000|Reported Event|Test Product|Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290975|NCT02937636|EG001|Reported Event|Reference Product|Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.
11290976|NCT02937701|BG000|Baseline|ABP 710|Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290977|NCT02937701|BG001|Baseline|Infliximab|Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290978|NCT02937701|BG002|Baseline|Total|Total of all reporting groups
11290979|NCT02937701|FG000|Participant Flow|ABP 710|Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290980|NCT02937701|FG001|Participant Flow|Infliximab|Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290981|NCT02937701|FG002|Participant Flow|ABP 710 / ABP 710|At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
10822203|NCT00075218|EG002|Reported Event|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
11290982|NCT02937701|FG003|Participant Flow|Infliximab / Infliximab|At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.
11290983|NCT02937701|FG004|Participant Flow|Infliximab / ABP 710|At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
11290984|NCT02937701|OG000|Outcome|ABP 710|Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290985|NCT02937701|OG001|Outcome|Infliximab|Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290986|NCT02937701|OG000|Outcome|ABP 710 / ABP 710|At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
11290987|NCT02937701|OG001|Outcome|Infliximab / Infliximab|At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.
11290988|NCT02937701|OG002|Outcome|Infliximab / ABP 710|At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
11290989|NCT02937701|EG000|Reported Event|ABP 710|Participants received 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290990|NCT02937701|EG001|Reported Event|Infliximab|Participants received 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
11290991|NCT02937701|EG002|Reported Event|ABP 710 / ABP 710|At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.
11290992|NCT02937701|EG003|Reported Event|Infliximab / Infliximab|At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46.
11290993|NCT02937701|EG004|Reported Event|Infliximab / ABP 710|At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46.
11290994|NCT02937740|BG000|Baseline|Naive Patients - ARM 1|"NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 5.5mg testosterone per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~To be given three times daily (after Visit 4 [Day 90]) if symptoms not adequately managed on BID."
11290995|NCT02937740|BG001|Baseline|Non-naive Patients - ARM 2|"NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 5.5mg testosterone per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~To be given three times daily (after Visit 4 [Day 90]) if symptoms not adequately managed on BID."
11290996|NCT02937740|BG002|Baseline|Total|Total of all reporting groups
11290997|NCT02937740|FG000|Participant Flow|Naive Patients - ARM 1|"NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.~For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID"
11290998|NCT02937740|FG001|Participant Flow|Non-naive Patients - ARM 2|"NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.~For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATE"
11290999|NCT02937740|OG000|Outcome|Natesto Testosterone Intranasal Gel Given BID|Patients who completed 90 days on BID NATESTO.
11291000|NCT02937740|OG001|Outcome|Natesto Testosterone Intranasal Gel Given TID|Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
11291001|NCT02937740|OG000|Outcome|Non-naive Patients - BID Treatment|"NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT.~For BID administration, NATESTO 22 mg/day of testosterone. Change in scores is between Day 90 and Baseline."
11291002|NCT02937740|OG001|Outcome|Naive Patients - BID Treatment|"NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.~For BID administration, NATESTO 22 mg/day of testosterone. Change in scores is between Day 90 and Baseline."
11291003|NCT02937740|OG002|Outcome|Non-naive Patients - TID Treatment|"NATESTO Testosterone Nasal Gel administered intranasally to patients previously on TRT.~Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline."
11291004|NCT02937740|OG003|Outcome|Naive Patients - TID Treatment|"NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.~Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline."
11291005|NCT02937740|OG000|Outcome|Naive Patients - ARM 1|"NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.~For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID"
11335792|NCT03557034|BG001|Baseline|Kardia Monitoring|"Kardia Mobile/Kardia Pro~Kardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."
10822204|NCT00075270|BG000|Baseline|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10822205|NCT00075270|BG001|Baseline|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
11291006|NCT02937740|OG001|Outcome|Non-naive Patients - ARM 2|"NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.~For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.~NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.~For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATE"
11291007|NCT02937740|EG000|Reported Event|Natesto Testosterone Intranasal Gel Given BID|Patients who completed 90 days on BID NATESTO.
11291008|NCT02937740|EG001|Reported Event|Natesto Testosterone Intranasal Gel Given TID|Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
11291009|NCT02937870|BG000|Baseline|Overall Study Participants|All randomized participants who received all four treatments: test adhesive 1, test adhesive 2, positive control adhesive and no adhesive were included in the baseline assessment.
11291010|NCT02937870|FG000|Participant Flow|Overall Study|This was a single-center, randomized, controlled, examiner-blind, four-treatment, four-period, crossover study. Participants received a single application of each study treatment, lasting for 12 hours.
11291011|NCT02937870|OG000|Outcome|Test Adhesive 1|Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
11291012|NCT02937870|OG001|Outcome|No Adhesive|Participants of this arm did not receive any adhesive to apply on upper denture.
11291013|NCT02937870|OG000|Outcome|Test Adhesive 2|Participants of this arm topically applied test adhesive 2 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
11291014|NCT02937870|OG001|Outcome|Positive Control Adhesive|Participants of this arm topically applied commercial denture adhesive to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
11291015|NCT02937870|OG000|Outcome|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291016|NCT02937870|OG001|Outcome|Positive Control Adhesive|Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291017|NCT02937870|OG000|Outcome|Test Adhesive 1|Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291018|NCT02937870|OG001|Outcome|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
10822206|NCT00075270|BG002|Baseline|Total|Total of all reporting groups
11291019|NCT02937870|EG000|Reported Event|Test Adhesive 1|Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291020|NCT02937870|EG001|Reported Event|Test Adhesive 2|Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291021|NCT02937870|EG002|Reported Event|Positive Control Adhesive|Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
11291022|NCT02937870|EG003|Reported Event|Negative Control|Participants of this arm did not receive any adhesive to apply on upper denture.
11291023|NCT02938052|BG000|Baseline|Intervention Arm|"Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10).~The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence."
11291024|NCT02938052|FG000|Participant Flow|PP-Based Health Behavior Intervention|"Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10).~The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence."
11291025|NCT02938052|OG000|Outcome|Intervention Arm|"Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10).~The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence."
11291026|NCT02938052|OG000|Outcome|PP-Based Health Behavior Intervention|"Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10).~The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence."
11291027|NCT02938052|EG000|Reported Event|Intervention Arm|"Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10).~The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence."
11291028|NCT02938169|BG000|Baseline|Walking Exercise Group|"**walking exercise~•walking exercise: treadmill gait with tolerable gait speed"
11291029|NCT02938169|BG001|Baseline|Stabilization Exercise Group|"** stabilization exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."
11291030|NCT02938169|BG002|Baseline|Walking and Stabilization Exercise Group|"**walking exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed"
11291031|NCT02938169|BG003|Baseline|Flexibility Exercise Group|"**Stretching exercise(control)~Only educate the flexibility exercise(stretching exercise)~Don't educate the walking exercise method and stabilization exercise method"
11291032|NCT02938169|BG004|Baseline|Total|Total of all reporting groups
11291033|NCT02938169|FG000|Participant Flow|Walking Exercise Group|"**walking exercise~•walking exercise: treadmill gait with tolerable gait speed"
11291034|NCT02938169|FG001|Participant Flow|Stabilization Exercise Group|"** stabilization exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."
11291035|NCT02938169|FG002|Participant Flow|Walking and Stabilization Exercise Group|"**walking exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed"
11291036|NCT02938169|FG003|Participant Flow|Flexibility Exercise Group|"**Stretching exercise(control)~Only educate the flexibility exercise(stretching exercise)~Don't educate the walking exercise method and stabilization exercise method"
11291037|NCT02938169|OG000|Outcome|Walking Exercise Group|"**walking exercise~•walking exercise: treadmill gait with tolerable gait speed"
11291038|NCT02938169|OG001|Outcome|Stabilization Exercise Group|"** stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~-bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as"
11291039|NCT02938169|OG002|Outcome|Walking and Stabilization Exercise Group|"**walking exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~-bracing exercise: patient is instructed as follows: Draw your navel up towards your head and i"
11291040|NCT02938169|OG003|Outcome|Flexibility Exercise Group|"**Stretching exercise(control)~Only educate the flexibility exercise(stretching exercise)~Don't educate the walking exercise method and stabilization exercise method~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~walking exercise: treadmill gait with tolerable gait speed~flexibility exercise: stretching exercise(control)"
11335793|NCT03557034|BG002|Baseline|Total|Total of all reporting groups
11335794|NCT03557034|FG000|Participant Flow|Standard of Care Monitoring|Standard of Care: Patients will be followed clinically based on symptoms.
10842456|NCT00246519|BG001|Baseline|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
11291041|NCT02938169|OG000|Outcome|Walking Exercise Group|"**walking exercise with bracing exercise~walking exercise: treadmill gait with tolerable gait speed~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~walking exercise: treadmill gait with tolerable gait speed~flexibility exercise: stretching exercise(control)"
11291042|NCT02938169|OG001|Outcome|Stabilization Exercise Group|"** stabilization exercise with bracing exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~-bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to"
11291043|NCT02938169|OG002|Outcome|Walking and Stabilization Exercise Group|"**walking exercise, bracing exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~-bracing exercise: patient is instructed as follows: Draw your navel up towar"
11291044|NCT02938169|OG001|Outcome|Stabilization Exercise Group|"** stabilization exercise with bracing exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."
11291045|NCT02938169|OG002|Outcome|Walking and Stabilization Exercise Group|"**walking exercise, bracing exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed"
11291046|NCT02938169|OG001|Outcome|Stabilization Exercise Group|"** stabilization exercise with bracing exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~walking exercise: treadmill gait with tolerable gait speed~flexibility exercise: stretching exercise(control)"
11291047|NCT02938169|OG002|Outcome|Walking and Stabilization Exercise Group|"**walking exercise, bracing exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~walking exercise: treadmill gait with tolerable gait speed"
11291048|NCT02938169|EG000|Reported Event|Walking Exercise Group|"**walking exercise with bracing exercise~walking exercise: treadmill gait with tolerable gait speed~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.~walking exercise: treadmill gait with tolerable gait speed~flexibility exercise: stretching exercise(control)"
11291049|NCT02938169|EG001|Reported Event|Stabilization Exercise Group|"** stabilization exercise~•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."
11291050|NCT02938169|EG002|Reported Event|Walking and Stabilization Exercise Group|"**walking exercise with stabilization exercise~stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.~walking exercise:treadmill gait with tolerable gait speed"
10842457|NCT00246519|BG002|Baseline|Total|Total of all reporting groups
11291051|NCT02938169|EG003|Reported Event|Flexibility Exercise Group|"**Stretching exercise(control)~Only educate the flexibility exercise(stretching exercise)~Don't educate the walking exercise method and stabilization exercise method"
11291052|NCT02938494|BG000|Baseline|IDP-123 Lotion|"Lotion~IDP-123 Lotion: Lotion"
11291053|NCT02938494|BG001|Baseline|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11291054|NCT02938494|BG002|Baseline|Vehicle Lotion|"Lotion~Vehicle Lotion: Lotion"
11291055|NCT02938494|BG003|Baseline|Vehicle Cream|"Cream~Vehicle Cream: Cream"
11291056|NCT02938494|BG004|Baseline|Total|Total of all reporting groups
11291057|NCT02938494|FG000|Participant Flow|IDP-123 Lotion|"Lotion~IDP-123 Lotion: Lotion"
11291058|NCT02938494|FG001|Participant Flow|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11291059|NCT02938494|FG002|Participant Flow|Vehicle Lotion|"Lotion~Vehicle Lotion: Lotion"
11291060|NCT02938494|FG003|Participant Flow|Vehicle Cream|"Cream~Vehicle Cream: Cream"
11291061|NCT02938494|OG000|Outcome|IDP-123 Lotion|0.045% tazarotene
11291062|NCT02938494|OG001|Outcome|Tazorac Cream|Tazorac Cream 0.1%
11291063|NCT02938494|OG002|Outcome|Vehicle Lotion and Vehicle Cream Combined|Vehicle Lotion and Vehicle Cream Combined
11291064|NCT02938494|EG000|Reported Event|IDP-123 Lotion|"Lotion~IDP-123 Lotion: Lotion"
11291065|NCT02938494|EG001|Reported Event|Tazorac Cream|"Cream~Tazorac Cream: Cream"
11291066|NCT02938494|EG002|Reported Event|Vehicle Lotion|"Lotion~Vehicle Lotion: Lotion"
11291067|NCT02938494|EG003|Reported Event|Vehicle Cream|"Cream~Vehicle Cream: Cream"
11291068|NCT02938585|BG000|Baseline|Small Children (0 to <6 Years)|Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291069|NCT02938585|BG001|Baseline|Older Children (6 to <12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291070|NCT02938585|BG002|Baseline|Adolescents (12 to <18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291071|NCT02938585|BG003|Baseline|Adults (>=18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291072|NCT02938585|BG004|Baseline|Total|Total of all reporting groups
11291073|NCT02938585|FG000|Participant Flow|Small Children (0 to <6 Years)|Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291074|NCT02938585|FG001|Participant Flow|Older Children (6 to <12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11335795|NCT03557034|FG001|Participant Flow|Kardia Monitoring|"Kardia Mobile/Kardia Pro~Kardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."
11291075|NCT02938585|FG002|Participant Flow|Adolescents (12 to <18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291076|NCT02938585|FG003|Participant Flow|Adults (>=18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291077|NCT02938585|OG000|Outcome|Small Children (0 to <6 Years)|Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291078|NCT02938585|OG001|Outcome|Older Children (6 to <12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291079|NCT02938585|OG002|Outcome|Adolescents (12 to <18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291080|NCT02938585|OG003|Outcome|Adults (>=18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291081|NCT02938585|OG003|Outcome|Adults (>=18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291082|NCT02938585|OG000|Outcome|Minor Surgery|Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.
11291083|NCT02938585|OG001|Outcome|Major Surgery|Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
11291084|NCT02938585|OG000|Outcome|Older Children (8 to 12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)).
11291085|NCT02938585|OG001|Outcome|Adolescents (12 to <18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291086|NCT02938585|OG002|Outcome|Adults (17 and Older)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291087|NCT02938585|OG000|Outcome|Older Children (8 to 12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)).
11291088|NCT02938585|OG001|Outcome|Adolescents (13 to 16 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291089|NCT02938585|OG002|Outcome|Adults (17 and Older)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291090|NCT02938585|OG000|Outcome|Small Children (4 to 7 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291091|NCT02938585|OG001|Outcome|Older Children (8 to 12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (small children (4 to 7 years) and adolescents (13 to 16 years)).
11336321|NCT03565068|EG009|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336322|NCT03565068|EG010|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11291092|NCT02938585|OG000|Outcome|Small Children (4 to 7 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291093|NCT02938585|OG001|Outcome|Older Children (8 to 12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (small children (4 to 7 years) and adolescents (13 to 16 years)).
11291094|NCT02938585|OG002|Outcome|Adolescents (13 to 16 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291095|NCT02938585|EG000|Reported Event|Small Children (0 to <6 Years)|Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291096|NCT02938585|EG001|Reported Event|Older Children (6 to <12 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291097|NCT02938585|EG002|Reported Event|Adolescents (12 to <18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291098|NCT02938585|EG003|Reported Event|Adults (>=18 Years)|Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
11291099|NCT02938949|BG000|Baseline|Alirocumab|"Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~alirocumab"
11291100|NCT02938949|BG001|Baseline|Placebo|"Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~placebo"
11291101|NCT02938949|BG002|Baseline|Total|Total of all reporting groups
10842458|NCT00246519|FG000|Participant Flow|Atenolol + Hydroclorothiazide (HCTZ) Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
11291102|NCT02938949|FG000|Participant Flow|Alirocumab|"Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~alirocumab"
11291103|NCT02938949|FG001|Participant Flow|Placebo|"Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~placebo"
11291104|NCT02938949|OG000|Outcome|Alirocumab|"Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~alirocumab"
11291105|NCT02938949|OG001|Outcome|Placebo|"Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~placebo"
11291106|NCT02938949|EG000|Reported Event|Alirocumab|"Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~alirocumab"
11291107|NCT02938949|EG001|Reported Event|Placebo|"Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.~placebo"
11291108|NCT02939014|BG000|Baseline|Brentuximab Vedotin 1.8 mg/kg (HL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).
11291109|NCT02939014|BG001|Baseline|Brentuximab Vedotin 1.8 mg/kg (sALCL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
11291110|NCT02939014|BG002|Baseline|Total|Total of all reporting groups
11291111|NCT02939014|FG000|Participant Flow|Brentuximab Vedotin 1.8 mg/kg (HL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).
11291112|NCT02939014|FG001|Participant Flow|Brentuximab Vedotin 1.8 mg/kg (sALCL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
11291113|NCT02939014|OG000|Outcome|Brentuximab Vedotin 1.8 mg/kg (HL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).
11291114|NCT02939014|OG001|Outcome|Brentuximab Vedotin 1.8 mg/kg (sALCL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
11291115|NCT02939014|OG000|Outcome|Brentuximab Vedotin 1.8 mg/kg|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
11291116|NCT02939014|EG000|Reported Event|Brentuximab Vedotin 1.8 mg/kg (HL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).
11291117|NCT02939014|EG001|Reported Event|Brentuximab Vedotin 1.8 mg/kg (sALCL)|Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
11291118|NCT02939079|BG000|Baseline|Fingolimod and Fish Oil|"Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Fish Oil: produced by Zahravi ® Pharm Company in Iran"
11291119|NCT02939079|BG001|Baseline|Fingolimod and Placebo|"Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules"
10822207|NCT00075270|FG000|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
11291120|NCT02939079|BG002|Baseline|Total|Total of all reporting groups
11291121|NCT02939079|FG000|Participant Flow|Fingolimod and Fish Oil|"Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Fish Oil: produced by Zahravi ® Pharm Company in Iran"
11291122|NCT02939079|FG001|Participant Flow|Fingolimod and Placebo|"Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules"
11291123|NCT02939079|OG000|Outcome|Fingolimod and Fish Oil|"Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Fish Oil: produced by Zahravi ® Pharm Company in Iran"
11291124|NCT02939079|OG001|Outcome|Fingolimod and Placebo|"Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules"
11291125|NCT02939079|EG000|Reported Event|Fingolimod and Fish Oil|"Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Fish Oil: produced by Zahravi ® Pharm Company in Iran"
11291126|NCT02939079|EG001|Reported Event|Fingolimod and Placebo|"Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.~Fingolimod: Produced by Osveh ® Pharm Company in Iran~Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules"
11291127|NCT02939105|BG000|Baseline|CoolSculpting Intervention Group|Subjects treated with CoolSculpting System for Arm Fat
11291128|NCT02939105|FG000|Participant Flow|CoolSculpting Intervention Group|The CoolSculpting System was used in the study. The study was designed to evaluate the safety and effectiveness of cryolypolysis for non-invasive reduction of upper arm fat.
11291129|NCT02939105|OG000|Outcome|CoolSculpting Intervention Group|Subjects treated with CoolSculpting for arm fat
11291130|NCT02939105|OG000|Outcome|CoolSculpting Intervention Group|Subjects treated with CoolSculpting System for arm fat
11291131|NCT02939105|EG000|Reported Event|CoolSculpting Intervention Group|CoolSculpting Treatment for Arm Fat
11291132|NCT02939131|BG000|Baseline|COMB-R|"Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention~Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm: Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects)."
11291133|NCT02939131|BG001|Baseline|Enhanced Standard of Care|"Enhanced Standard of Care (ESC)~Enhanced Standard of Care: Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression."
11291134|NCT02939131|BG002|Baseline|Total|Total of all reporting groups
11291135|NCT02939131|FG000|Participant Flow|COMB-R|"Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention~Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm: Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects)."
11291136|NCT02939131|FG001|Participant Flow|Enhanced Standard of Care|"Enhanced Standard of Care (ESC)~Enhanced Standard of Care: Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression."
11291137|NCT02939131|OG000|Outcome|COMB-R|Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention
11291138|NCT02939131|OG001|Outcome|Enhanced Standard of Care|"Enhanced Standard of Care (ESC)~Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training"
11291139|NCT02939131|OG000|Outcome|Enhanced Standard of Care|"Enhanced Standard of Care (ESC)~Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training"
11291140|NCT02939131|EG000|Reported Event|COMB-R|Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention
11291141|NCT02939131|EG001|Reported Event|Enhanced Standard of Care (ESC)|Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training.
11291142|NCT02939170|BG000|Baseline|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
11291143|NCT02939170|BG001|Baseline|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
11291144|NCT02939170|BG002|Baseline|Total|Total of all reporting groups
11291145|NCT02939170|FG000|Participant Flow|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
11291146|NCT02939170|FG001|Participant Flow|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
10842459|NCT00246519|FG001|Participant Flow|Hydrochlorothiazide (HCTZ) + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
11291147|NCT02939170|OG000|Outcome|DT1 MF MM|Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
11291148|NCT02939170|OG001|Outcome|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
11291149|NCT02939170|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to initiation of study treatment
11291150|NCT02939170|EG001|Reported Event|DT1 MF MM|All subjects exposed to delefilcon A multifocal contact lenses with molded marks
11291151|NCT02939170|EG002|Reported Event|DT1 MF|All subjects exposed to delefilcon A multifocal contact lenses
11291152|NCT02939326|BG000|Baseline|Placebo|"Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.~Placebo injection"
11291153|NCT02939326|BG001|Baseline|EB-001 Dose 1|"1st Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291154|NCT02939326|BG002|Baseline|EB-001 Dose 2|"2nd Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291155|NCT02939326|BG003|Baseline|EB-001 Dose 3|"3rd Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291156|NCT02939326|BG004|Baseline|EB-001 Dose 4|"4th Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291157|NCT02939326|BG005|Baseline|EB-001 Dose 5|"5thDose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291158|NCT02939326|BG006|Baseline|EB-001 Dose 6|"6th Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291159|NCT02939326|BG007|Baseline|EB-001 Dose 7|"7th Dose in escalation paradigm.~Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291160|NCT02939326|BG008|Baseline|Total|Total of all reporting groups
11291161|NCT02939326|FG000|Participant Flow|Placebo|"Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.~Placebo injection"
11291162|NCT02939326|FG001|Participant Flow|EB-001 Dose 1 (1X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection"
11291163|NCT02939326|FG002|Participant Flow|EB-001 Dose 2 (3X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 3X Dose 1"
11291164|NCT02939326|FG003|Participant Flow|EB-001 Dose 3 (9X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 9X dose 1"
11291165|NCT02939326|FG004|Participant Flow|EB-001 Dose 4 (12X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 12X Dose 1"
11291166|NCT02939326|FG005|Participant Flow|EB-001 Dose 5 (16X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 16X Dose 1"
11291167|NCT02939326|FG006|Participant Flow|EB-001 Dose 6 (21X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 21X Dose 1"
11291168|NCT02939326|FG007|Participant Flow|EB-001 Dose 7 (28X)|"Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.~EB-001 injection 28X Dose 1"
11291169|NCT02939326|OG000|Outcome|Placebo|"Single Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.~Placebo injection"
11291170|NCT02939326|OG001|Outcome|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291171|NCT02939326|OG002|Outcome|EB-001 Dose 2 (3X)|"2nd dose in escalation paradigm, 3X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291172|NCT02939326|OG003|Outcome|EB-001 Dose 3 (9X)|"3rd Dose in escalation paradigm, 9X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291173|NCT02939326|OG004|Outcome|EB-001 Dose 4 (12X)|"4th Dose in escalation paradigm, 12X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291174|NCT02939326|OG005|Outcome|EB-001 Dose 5 (16X)|"5th Dose in escalation paradigm, 16X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291175|NCT02939326|OG006|Outcome|EB-001 Dose 6 (21X)|"6th Dose in escalation paradigm, 21X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291176|NCT02939326|OG007|Outcome|EB-001 Dose 7 (28X)|"7th Dose in escalation paradigm, 28X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291177|NCT02939326|EG000|Reported Event|Placebo|"Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.~Placebo injection"
11291178|NCT02939326|EG001|Reported Event|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291179|NCT02939326|EG002|Reported Event|EB-001 Dose 2 (3X)|"2nd dose in escalation paradigm, 3X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291180|NCT02939326|EG003|Reported Event|EB-001 Dose 3 (9X)|"3rd Dose in escalation paradigm, 9X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291181|NCT02939326|EG004|Reported Event|EB-001 Dose 4 (12X)|"4th Dose in escalation paradigm, 12X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291182|NCT02939326|EG005|Reported Event|EB-001 Dose 5 (16X)|"5th Dose in escalation paradigm, 16X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area"
11291183|NCT02939326|EG006|Reported Event|EB-001 Dose 6 (21X)|"6th Dose in escalation paradigm, 21X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291184|NCT02939326|EG007|Reported Event|EB-001 Dose 7 (28X)|"7th Dose in escalation paradigm, 28X Dose 1.~Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area."
11291185|NCT02939560|BG000|Baseline|rTMS|"Participants will receive rTMS sessions according to the study protocol.~NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)."
11291186|NCT02939560|FG000|Participant Flow|rTMS|"Participants will receive rTMS sessions according to the study protocol.~NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)."
11291187|NCT02939560|OG000|Outcome|rTMS|"Participants will receive rTMS sessions according to the study protocol.~NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)."
11291188|NCT02939560|EG000|Reported Event|rTMS|"Participants will receive rTMS sessions according to the study protocol.~NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)."
11291189|NCT02939599|BG000|Baseline|Arm 1|"Subjects randomized in the QCC374X2201 core study continued on QCC374 at their highest stable dose, in this extension study 0.12mg~-active patients will continue at the dose they finished on the QCC374X2201 study"
11291190|NCT02939599|BG001|Baseline|Arm2|Subjects randomized to placebo in the QCC374X2201 core study completed a titration scheme similar to that of the active arm in QCC374X2201 core study protocol
11291191|NCT02939599|BG002|Baseline|Total|Total of all reporting groups
11291192|NCT02939599|FG000|Participant Flow|Arm 1|Subjects randomized in the QCC374X2201 core study continued on QCC374 at their highest stable dose, in this extension study
11291193|NCT02939599|FG001|Participant Flow|Arm 2|Subjects randomized to placebo in the QCC374X2201 core study completed a titration scheme similar to that of the active arm in QCC374X2201 core study protocol
11291194|NCT02939599|OG000|Outcome|Arm 1|Subjects randomized in the QCC374X2201 core study continued on QCC374 at their highest stable dose, in this extension study 0.12mg -active patients will continue at the dose they finished on the QCC374X2201 study
11291195|NCT02939599|OG001|Outcome|Arm 2|Subjects randomized to placebo in the QCC374X2201 core study completed a titration scheme similar to that of the active arm in QCC374X2201 core study protocol
11291196|NCT02939599|OG000|Outcome|QCC374|"placebo patients from QCC374X2201 rolled into extension study will start at 0.03mg b.i.d. or 0.06mg b.i.d. and have the opportunity to up-titrate 0.12mg~-active patients will continue at the dose they finished on the QCC374X2201 study"
11291197|NCT02939599|EG000|Reported Event|QCC374 Arm 1|Subjects randomized in the QCC374X2201 core study continued on QCC374 at their highest stable dose, in this extension study 0.12mg -active patients will continue at the dose they finished on the QCC374X2201 study
11291198|NCT02939599|EG001|Reported Event|QCC374 Arm 2|Subjects randomized to placebo in the QCC374X2201 core study completed a titration scheme similar to that of the active arm in QCC374X2201 core study protocol
11291199|NCT02939651|BG000|Baseline|Pembrolizumab|"Monotherapy with PD-1 antibody pembrolizumab~Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks"
11291200|NCT02939651|FG000|Participant Flow|Pembrolizumab|"Monotherapy with PD-1 antibody pembrolizumab~Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks"
11291201|NCT02939651|OG000|Outcome|Pembrolizumab|"Monotherapy with PD-1 antibody pembrolizumab~Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks"
11291202|NCT02939651|EG000|Reported Event|Pembrolizumab|"Monotherapy with PD-1 antibody pembrolizumab~Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks"
11291203|NCT02939716|BG000|Baseline|Healthy Volunteers|Healthy volunteer group who participated
11291204|NCT02939716|FG000|Participant Flow|Healthy Volunteers. Bread Then Lettuce Then Rhubarb|Healthy volunteers free from GI disease. Randomised to order Bread then Lettuce then Rhubarb
11291205|NCT02939716|FG001|Participant Flow|Healthy Volunteers. Bread Then Rhubarb Then Lettuce|Healthy volunteers free from GI disease. Randomised to order Bread then Rhubarb then Lettuce
11291206|NCT02939716|FG002|Participant Flow|Healthy Volunteers. Lettuce Then Rhubarb Then Bread|Healthy volunteers free from GI disease. Randomised to order Lettuce then Rhubarb then Bread
11291207|NCT02939716|FG003|Participant Flow|Healthy Volunteers. Lettuce Then Bread Then Rhubarb|Healthy volunteers free from GI disease. Randomised to order Lettuce then Bread then Rhubarb
11291208|NCT02939716|FG004|Participant Flow|Healthy Volunteers. Rhubarb Then Bread Then Lettuce|Healthy volunteers free from GI disease. Randomised to order Rhubarb then Bread then Lettuce
11291209|NCT02939716|FG005|Participant Flow|Healthy Volunteers. Rhubarb Then Lettuce Then Bread|Healthy volunteers free from GI disease. Randomised to order Rhubarb then Lettuce then Bread
11291210|NCT02939716|OG000|Outcome|Healthy Volunteers. Bread Arm.|Bread Arm.
11291211|NCT02939716|OG001|Outcome|Healthy Volunteers. Lettuce Arm|Lettuce Arm
11291212|NCT02939716|OG002|Outcome|Healthy Volunteers. Rhubarb Arm|Rhubarb Arm
11291213|NCT02939716|OG000|Outcome|Bread|Bread Arm
11291214|NCT02939716|OG001|Outcome|Lettuce|Lettuce Arm
11291215|NCT02939716|OG002|Outcome|Rhubarb|Rhubarb Arm
11291216|NCT02939716|OG000|Outcome|Bread|Bread arm
11291217|NCT02939716|OG001|Outcome|Lettuce|Lettuce arm
11291218|NCT02939716|OG002|Outcome|Rhubarb|Rhubarb arm
11291219|NCT02939716|EG000|Reported Event|Healthy Volunteers. Bread Then Lettuce Then Rhubarb|Healthy Volunteers. Treatment order Bread Then Lettuce Then Rhubarb
10970938|NCT00912990|BG000|Baseline|Cisatracurium|"Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.~Cisatracurium : One intravenous dose: 0.2mg/kg/dose"
10970939|NCT00912990|BG001|Baseline|Normal Saline|"Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg~Normal saline : One Intravenous dose"
11291220|NCT02939716|EG001|Reported Event|Healthy Volunteers. Bread Then Rhubarb Then Lettuce|Healthy Volunteers. Treatment order Bread Then Rhubarb Then Lettuce
11291221|NCT02939716|EG002|Reported Event|Healthy Volunteers. Lettuce Then Rhubarb Then Bread|Healthy Volunteers. Treatment order Lettuce Then Rhubarb Then Bread
11291222|NCT02939716|EG003|Reported Event|Healthy Volunteers. Lettuce Then Bread Then Rhubarb|Healthy Volunteers. Treatment order Lettuce Then Bread Then Rhubarb
11291223|NCT02939716|EG004|Reported Event|Healthy Volunteers. Rhubarb Then Bread Then Lettuce|Healthy Volunteers. Treatment order Rhubarb Then Bread Then Lettuce
11291224|NCT02939716|EG005|Reported Event|Healthy Volunteers. Rhubarb Then Lettuce Then Bread|Healthy Volunteers. Treatment order Rhubarb Then Lettuce Then Bread
11291225|NCT02939781|BG000|Baseline|Febrile Critically Ill Children|"Children above 10kg admitted to the paediatric intensive care unit at Great Ormond Street Hospital who are mechanically ventilated and have a high likelihood of developing a fever. Energy expenditure will be measured using indirect calorimetry at baseline, and continuously during fever, until fever subsides.~Indirect calorimetry: Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence"
11291226|NCT02939781|FG000|Participant Flow|Critically Ill Children With or Likely to Have Fever|"Children above 10kg admitted to the paediatric intensive care unit at Great Ormond Street Hospital who are mechanically ventilated and have a high likelihood of developing a fever. Energy expenditure will be measured using indirect calorimetry at baseline, and continuously during fever, until fever subsides.~Indirect calorimetry: Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence"
11291227|NCT02939781|OG000|Outcome|Change in Energy Expenditure During Fever|Children who had rise in temperature during Calorimetry measurement
11291228|NCT02939781|OG001|Outcome|Change in Energy Expenditure During Fever Defervescence|Children who had a fall in temperature from a fever grade temperature (>=38C) during calorimetry
11291229|NCT02939781|EG000|Reported Event|Critically Ill Children With or Likely to Have Fever|All Critically ill children with or likely to have fever who had calorimetry measurement
11291230|NCT02939937|BG000|Baseline|Phenytoin|"patients received phenytoin 100mg three time daily up to 3 months~Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291231|NCT02939937|BG001|Baseline|Placebo|"patients received placebo 100 mg three time daily for 3 months~placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291232|NCT02939937|BG002|Baseline|Total|Total of all reporting groups
11291233|NCT02939937|FG000|Participant Flow|Phenytoin|"patients received phenytoin 100mg three time daily up to 3 months~Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291234|NCT02939937|FG001|Participant Flow|Placebo|"patients received placebo 100 mg three time daily for 3 months~placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291235|NCT02939937|OG000|Outcome|Phenytoin|"patients received phenytoin 100mg three time daily up to 3 months~Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291236|NCT02939937|OG001|Outcome|Placebo|"patients received placebo 100 mg three time daily for 3 months~placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291237|NCT02939937|EG000|Reported Event|Phenytoin|"patients received phenytoin 100mg three time daily up to 3 months~Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291238|NCT02939937|EG001|Reported Event|Placebo|"patients received placebo 100 mg three time daily for 3 months~placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later."
11291239|NCT02939950|BG000|Baseline|Bausch + Lomb Samfilcon A Soft Contact Lens|Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291240|NCT02939950|BG001|Baseline|Bausch + Lomb Pure Vision Soft Contact Lens|Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291241|NCT02939950|BG002|Baseline|Total|Total of all reporting groups
11291242|NCT02939950|FG000|Participant Flow|Bausch + Lomb Samfilcon A Soft Contact Lens|Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291243|NCT02939950|FG001|Participant Flow|Bausch + Lomb Pure Vision Soft Contact Lens|Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291244|NCT02939950|OG000|Outcome|Bausch + Lomb Samfilcon A Soft Contact Lens|Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
10842460|NCT00246519|OG000|Outcome|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
11291245|NCT02939950|OG001|Outcome|Bausch + Lomb Pure Vision Soft Contact Lens|Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291246|NCT02939950|EG000|Reported Event|Bausch + Lomb Samfilcon A Soft Contact Lens|Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291247|NCT02939950|EG001|Reported Event|Bausch + Lomb Pure Vision Soft Contact Lens|Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
11291248|NCT02940249|BG000|Baseline|All Study Participants|All participants completing all study interventions
11291249|NCT02940249|FG000|Participant Flow|Doses of Apple Extract|Randomised sequences of singled doses of 0, 0.9, 1.2 and 1.8 g apple extract consumed with a test meal. Participants first received intervention 1 on the morning of a study visit, followed by a washout period of at least 7 days, then intervention 2 followed by a 7 day washout period, then intervention 3 followed by a 7 day washout period, then intervention 4.
10970940|NCT00912990|BG002|Baseline|Total|Total of all reporting groups
11291250|NCT02940249|OG000|Outcome|1.8 g Apple Extract|High dose of polyphenol apple extract in a drink
11291251|NCT02940249|OG001|Outcome|1.2 g Apple Extract|Medium dose of polyphenol apple extract in a drink
11291252|NCT02940249|OG002|Outcome|0.9 g Apple Extract|Low dose of apple extract in a drink
11291253|NCT02940249|OG003|Outcome|0 g Apple Extract|Control in a drink matched for appearance and macronutrients
11291254|NCT02940249|EG000|Reported Event|1.8 g Apple Extract|High dose of polyphenol apple extract in a drink
11291255|NCT02940249|EG001|Reported Event|1.2 g Apple Extract|Medium dose of polyphenol apple extract in a drink
11291256|NCT02940249|EG002|Reported Event|0.9 g Apple Extract|Low dose of apple extract in a drink
11291257|NCT02940249|EG003|Reported Event|0 g Apple Extract|Control in a drink matched for appearance and macronutrients
11291258|NCT02940327|BG000|Baseline|1 - Observational Case-Controls|Observational Case-Controls.
11291259|NCT02940327|FG000|Participant Flow|1 - Observational Case-Controls|Observational Case-Controls.
11291260|NCT02940327|OG000|Outcome|7+ Days|on ECMO
11291261|NCT02940327|OG001|Outcome|<7 Days|on ECMO
11291262|NCT02940327|EG000|Reported Event|1 - Observational Case-Controls|Observational Case-Controls.
11291263|NCT02940392|BG000|Baseline|Rezum Treatment|"Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.~Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.~The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291264|NCT02940392|FG000|Participant Flow|Rezum Treatment|"Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.~Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.~The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291265|NCT02940392|OG000|Outcome|Rezum Treatment|"Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.~Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.~The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291266|NCT02940392|EG000|Reported Event|Rezum Treatment|"Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.~Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.~The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291267|NCT02940574|BG000|Baseline|Syntocinon (Oxytocin, Product Code RVG 03716)|"Administration via nasal spray~Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291268|NCT02940574|BG001|Baseline|Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))|"Administration via nasal spray~Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291269|NCT02940574|BG002|Baseline|Total|Total of all reporting groups
11291270|NCT02940574|FG000|Participant Flow|Syntocinon (Oxytocin, Product Code RVG 03716)|"Administration via nasal spray~Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
10970941|NCT00912990|FG000|Participant Flow|Cisatracurium|"Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.~Cisatracurium : One intravenous dose: 0.2mg/kg/dose"
11291271|NCT02940574|FG001|Participant Flow|Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))|"Administration via nasal spray~Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291272|NCT02940574|OG000|Outcome|Syntocinon (Oxytocin, Product Code RVG 03716)|"Administration via nasal spray~Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril)."
11291273|NCT02940574|OG001|Outcome|Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))|"Administration via nasal spray~Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray."
11291274|NCT02940574|OG000|Outcome|Syntocinon (Oxytocin, Product Code RVG 03716)|"Administration via nasal spray~Syntocinon (Oxytocin): Syntocinon nasal spray. 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291275|NCT02940574|OG000|Outcome|Syntocinon (Oxytocin, Product Code RVG 03716)|Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril)
11291276|NCT02940574|OG000|Outcome|Syntocinon (Oxytocin, Product Code RVG 03716)|Syntocinon (Oxytocin): Syntocinon nasal spray. 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
11291277|NCT02940574|OG001|Outcome|Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))|Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray.
11291278|NCT02940574|EG000|Reported Event|Syntocinon (Oxytocin, Product Code RVG 03716)|"Administration via nasal spray~Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291279|NCT02940574|EG001|Reported Event|Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))|"Administration via nasal spray~Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray"
11291280|NCT02940626|BG000|Baseline|ASN100|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100 3600 mg: monoclonal antibody combination of ASN-1(1800 mg) and ASN-2(1800 mg) [administered once]"
11291281|NCT02940626|BG001|Baseline|Placebo|"Placebo administered as 2 separate intravenous (IV) infusions~Placebo: Placebo [administered once]"
11291282|NCT02940626|BG002|Baseline|Total|Total of all reporting groups
11291283|NCT02940626|FG000|Participant Flow|ASN100|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100 3600 mg: monoclonal antibody combination of ASN-1(1800 mg) and ASN-2(1800 mg) [administered once]"
11291284|NCT02940626|FG001|Participant Flow|Placebo|"Placebo administered as 2 separate intravenous (IV) infusions~Placebo: Placebo [administered once]"
11291285|NCT02940626|OG000|Outcome|ASN100|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100: monoclonal antibody combination of ASN-1 and ASN-2"
10822208|NCT00075270|FG001|Participant Flow|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10970942|NCT00912990|FG001|Participant Flow|Normal Saline|"Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg~Normal saline : One Intravenous dose"
10970943|NCT00912990|OG000|Outcome|Cisatracurium|"Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.~Cisatracurium : One intravenous dose: 0.2mg/kg/dose"
11291286|NCT02940626|OG001|Outcome|Placebo|"Placebo administered as 2 separate intravenous (IV) infusions~Placebo: Placebo"
11291287|NCT02940626|OG000|Outcome|ASN-1|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100: monoclonal antibody combination of ASN-1 and ASN-2. Pharmacokinetic analysis was performed and reported based on the separate antibodies (i.e. ASN-1 or ASN-2)"
11291288|NCT02940626|OG001|Outcome|ASN-2|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100: monoclonal antibody combination of ASN-1 and ASN-2. Pharmacokinetic analysis was performed and reported based on the separate antibodies (i.e. ASN-1 or ASN-2)"
11291289|NCT02940626|EG000|Reported Event|ASN100|"ASN100 administered as 2 separate intravenous (IV) infusions~ASN100: monoclonal antibody combination of ASN-1 and ASN-2"
11291290|NCT02940626|EG001|Reported Event|Placebo|"Placebo administered as 2 separate intravenous (IV) infusions~Placebo: Placebo"
11291291|NCT02940691|BG000|Baseline|Grazoprevir/Elbasvir|Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
11291292|NCT02940691|FG000|Participant Flow|Grazoprevir/Elbasvir|Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
11291293|NCT02940691|OG000|Outcome|Grazoprevir/Elbasvir|Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
11291294|NCT02940691|OG000|Outcome|Xpert HCV VL Fingerstick|Sensitivity and specificity of the Xpert HCV VL Fingerstick assay for HCV detection in capillary whole-blood samples collected via fingerstick compares with Aptima HCV Quant Dx perforomed on EDTA plasma stored at -80C collected via venepuncture.
11291295|NCT02940691|EG000|Reported Event|Grazoprevir/Elbasvir|Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
11291296|NCT02940730|BG000|Baseline|Dalbavancin Via IV, Then Via IP|"Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange"
11291297|NCT02940730|BG001|Baseline|Dalbavancin Via IP, Then Via IV|"Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291298|NCT02940730|BG002|Baseline|Total|Total of all reporting groups
11291299|NCT02940730|FG000|Participant Flow|Dalbavancin Via IV, Then Via IP|"Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291300|NCT02940730|FG001|Participant Flow|Dalbavancin Via IP, Then Via IV|"Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291301|NCT02940730|OG000|Outcome|Dalbavancin Via IV|"Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291302|NCT02940730|OG001|Outcome|Dalbavancin Via IP|"Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291303|NCT02940730|EG000|Reported Event|Dalbavancin Via IV|"Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intravenous Administration: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291304|NCT02940730|EG001|Reported Event|Dalbavancin Via IP|"Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.~Dalbavancin via Intraperitoneal Administration: Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange."
11291305|NCT02940860|BG000|Baseline|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11291306|NCT02940860|BG001|Baseline|Iron Sucrose|Iron sucrose, administered IV
11291307|NCT02940860|BG002|Baseline|Total|Total of all reporting groups
11291308|NCT02940860|FG000|Participant Flow|Iron Isomaltoside/Ferric Derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit."
11291309|NCT02940860|FG001|Participant Flow|Iron Sucrose|"Iron sucrose (Venofer®) was the comparator in this trial.~Subjects received iron sucrose (Venofer®), 200 mg IV injection up to a maximum of 5 IV injections within the first 2 weeks, starting at baseline (a cumulative dose of 1000 mg was recommended)."
11291310|NCT02940860|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11291311|NCT02940860|OG001|Outcome|Iron Sucrose|Iron sucrose, administered IV
11291312|NCT02940860|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|"Health care staff involved in the iron isomaltoside/ferric derisomaltose treatment group.~Assessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time)."
11291313|NCT02940860|OG001|Outcome|Iron Sucrose|"Health care staff involved in the iron sucrose treatment group.~Assessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time)."
11291314|NCT02940860|EG000|Reported Event|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
10970944|NCT00912990|OG001|Outcome|Normal Saline|"Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg~Normal saline : One Intravenous dose"
11291315|NCT02940860|EG001|Reported Event|Iron Sucrose|Iron sucrose, administered IV
11291316|NCT02940886|BG000|Baseline|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
10970945|NCT00912990|EG000|Reported Event|Cisatracurium|"Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.~Cisatracurium : One intravenous dose: 0.2mg/kg/dose"
11291317|NCT02940886|BG001|Baseline|Iron Sucrose|Iron sucrose, administered IV
11291318|NCT02940886|BG002|Baseline|Total|Total of all reporting groups
11291319|NCT02940886|FG000|Participant Flow|Iron Isomaltoside/Ferric Derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit."
11291320|NCT02940886|FG001|Participant Flow|Iron Sucrose|"Iron sucrose (Venofer®) was the comparator in this trial.~Subjects received iron sucrose (Venofer®), 200 mg IV injection up to a maximum of 5 intravenous injections within the first 2 weeks, starting at baseline (a cumulative dose of 1000 mg was recommended)."
11291321|NCT02940886|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11291322|NCT02940886|OG001|Outcome|Iron Sucrose|Iron sucrose, administered IV
11291323|NCT02940886|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|"Health care staff involved in the iron isomaltoside/ferric derisomaltose treatment group.~Assessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time)."
11291324|NCT02940886|OG001|Outcome|Iron Sucrose|"Health care staff involved in the iron sucrose treatment group.~Assessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time)."
11291325|NCT02940886|EG000|Reported Event|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11291326|NCT02940886|EG001|Reported Event|Iron Sucrose|Iron sucrose, administered IV
11291327|NCT02941523|BG000|Baseline|NOX66 400 mg|NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291328|NCT02941523|BG001|Baseline|NOX66 800 mg|NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291329|NCT02941523|BG002|Baseline|Total|Total of all reporting groups
11291330|NCT02941523|FG000|Participant Flow|NOX66 400 mg|NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291331|NCT02941523|FG001|Participant Flow|NOX66 800 mg|NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291332|NCT02941523|OG000|Outcome|NOX66 400 mg Monotherapy|NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1)
11291333|NCT02941523|OG001|Outcome|NOX66 400 mg Combination Therapy|NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291334|NCT02941523|OG002|Outcome|NOX66 800 mg Monotherapy|NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1)
11291335|NCT02941523|OG003|Outcome|NOX66 800 mg Combination Therapy|NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291336|NCT02941523|OG000|Outcome|NOX66 400 mg + Carboplatin (AUC4) to Cycle 3|NOX66 400 mg administered daily for 14 day in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with low dose carboplatin AUC = 4 for treatment cycles 1-3
11291337|NCT02941523|OG001|Outcome|NOX66 400 mg + Carboplatin (AUC6) to Cycle 6|NOX66 400 mg administered daily for 14 day in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291338|NCT02941523|OG002|Outcome|NOX66 800 mg + Carboplatin (AUC4) to Cycle 3|NOX66 800 mg administered daily for 14 day in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with low dose carboplatin AUC = 4 for treatment cycles 1-3
10842461|NCT00246519|OG001|Outcome|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
10842462|NCT00246519|EG000|Reported Event|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
11291339|NCT02941523|OG003|Outcome|NOX66 800 mg + Carboplatin (AUC6) to Cycle 6|NOX66 800 mg administered daily for 14 day in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291340|NCT02941523|EG000|Reported Event|Monotherapy Phase, NOX66 400 mg|NOX66 400 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
11291341|NCT02941523|EG001|Reported Event|Monotherapy Phase, NOX66 800 mg|NOX66 800 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
11291342|NCT02941523|EG002|Reported Event|Combination Phase, NOX66 400 mg|Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 400 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11291343|NCT02941523|EG003|Reported Event|Combination Phase, NOX66 800 mg|Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 800 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
11332537|NCT03497039|BG000|Baseline|Diclofenac Diethylamine (DDEA) Gel|Participants randomized to this group were instructed to apply DDEA 2.32% gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332538|NCT03497039|BG001|Baseline|Placebo Gel|Participants randomized to this group were instructed to apply Placebo gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332539|NCT03497039|BG002|Baseline|Total|Total of all reporting groups
11332540|NCT03497039|FG000|Participant Flow|Diclofenac Diethylamine (DDEA) Gel|Participants randomized to this group were instructed to apply DDEA 2.32% gel topically,4grams(g) for about 1minute over a region of approximately 400 square centimeter(cm^2)per knee, every 12hours (hrs) twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days.If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol,500milligrams [mg] tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332541|NCT03497039|FG001|Participant Flow|Placebo Gel|Participants randomized to this group were instructed to apply Placebo gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332542|NCT03497039|OG000|Outcome|Diclofenac Diethylamine (DDEA) Gel|Participants randomized to this group were instructed to apply DDEA 2.32% gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332543|NCT03497039|OG001|Outcome|Placebo Gel|Participants randomized to this group were instructed to apply Placebo gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332544|NCT03497039|EG000|Reported Event|Diclofenac Diethylamine (DDEA) Gel|Participants randomized to this group were instructed to apply DDEA 2.32% gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11332545|NCT03497039|EG001|Reported Event|Placebo Gel|Participants randomized to this group were instructed to apply Placebo gel topically, 4 g for about 1minute over a region of approximately 400 cm^2 per knee, every 12 hrs twice daily for 7days. First and last doses were applied by trained nurse at study site. Last dose of study treatment administered at study site 12hrs (-1/+3hrs) prior to arthroplasty surgery (Day 7). If surgery delayed by up to 7days dosing with DDEA gel twice daily continued up to 14days. If surgery delayed by more than 7days,participant withdrawn from study. Rescue medication (Paracetamol, 500 mg tablets) provided at screening visit and instructed to take only if needed 1or2 tablets repeated after at least 4hrs up to 4times daily, up to a maximum of 4g per day.
11336323|NCT03565068|EG011|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11291344|NCT02941614|BG000|Baseline|Distress Screening|"Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).~Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm. The PHQ starts with a 2-item screen, and branches to the full screening instrument as needed."
11291345|NCT02941614|BG001|Baseline|No Screening|Newly diagnosed breast cancer patients will experience usual care.
11291346|NCT02941614|BG002|Baseline|Total|Total of all reporting groups
11291347|NCT02941614|FG000|Participant Flow|Distress Screening|"Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).~Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm."
11291348|NCT02941614|FG001|Participant Flow|No Screening|Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
11291349|NCT02941614|OG000|Outcome|Distress Screening|"Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).~Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm."
11291350|NCT02941614|OG001|Outcome|No Screening|Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
11291351|NCT02941614|OG000|Outcome|Intervention|"Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).~Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire-9 (PHQ-9), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm."
11291352|NCT02941614|OG001|Outcome|Control|Newly diagnosed breast cancer patients will experience usual care.
11291353|NCT02941614|EG000|Reported Event|Distress Screening|"Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).~Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm."
11291354|NCT02941614|EG001|Reported Event|No Screening|Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
11291355|NCT02941627|BG000|Baseline|Neuro Zti/Neuro One Study Group|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients will receive a Neuro Zti implant and fit with Neuro One sound processor"
11291356|NCT02941627|FG000|Participant Flow|Neuro Zti/Neuro One Study Group|All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
11291357|NCT02941627|OG000|Outcome|Neuro Zti/Neuro One English-Speaking Participants - 6 Months|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor"
11291358|NCT02941627|OG000|Outcome|Neuro Zti/Neuro One Study Group|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor."
11291359|NCT02941627|OG000|Outcome|Neuro Zti/Neuro One English-speaking Participants 3 Months|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor~Clinical benefit is assessed in English-speaking participants at 3 months follow up."
11291360|NCT02941627|OG001|Outcome|Neuro Zti/Neuro One English-speaking Participants 6 Months|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor~Clinical benefit is assessed in English-speaking participants at 6 months follow-up"
11291361|NCT02941627|OG002|Outcome|Neuro Zti/Neuro One English-speaking Participants 12 Months|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor~Clinical benefit is assessed in English-speaking participants at 12 months follow-up"
11291362|NCT02941627|OG000|Outcome|Neuro Zti/Neuro One English Speaking Participants|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor"
11291363|NCT02941627|OG000|Outcome|Overall Study Participants|"Neuro Zti: cochlear implant Neuro One: sound processor~All patients received a Neuro Zti implant and fitted with Neuro One sound processor"
11291364|NCT02941627|EG000|Reported Event|Neuro Zti/Neuro One Study Group|Neuro Zti: implant Neuro One: sound processor All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
11291365|NCT02941640|BG000|Baseline|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
11291366|NCT02941640|BG001|Baseline|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
11291367|NCT02941640|BG002|Baseline|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
11291368|NCT02941640|BG003|Baseline|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
11291369|NCT02941640|BG004|Baseline|Total|Total of all reporting groups
11291370|NCT02941640|FG000|Participant Flow|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
11291371|NCT02941640|FG001|Participant Flow|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
11291372|NCT02941640|FG002|Participant Flow|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
11291373|NCT02941640|FG003|Participant Flow|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
11291374|NCT02941640|OG000|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
11291375|NCT02941640|OG001|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
11291376|NCT02941640|OG002|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
11291377|NCT02941640|OG003|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
11291378|NCT02941640|EG000|Reported Event|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
11291379|NCT02941640|EG001|Reported Event|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
11291380|NCT02941640|EG002|Reported Event|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
11291381|NCT02941640|EG003|Reported Event|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
11291382|NCT02941692|BG000|Baseline|Oxytocin|"Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.~Oxytocin"
11291383|NCT02941692|BG001|Baseline|Placebo|"Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.~Placebo: Placebo for Oxytocin"
11291384|NCT02941692|BG002|Baseline|Total|Total of all reporting groups
11291385|NCT02941692|FG000|Participant Flow|Oxytocin|"Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.~Oxytocin"
11291386|NCT02941692|FG001|Participant Flow|Placebo|"Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.~Placebo: Placebo for Oxytocin"
11291387|NCT02941692|OG000|Outcome|Oxytocin|"Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.~Oxytocin"
11291388|NCT02941692|OG001|Outcome|Placebo|"Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.~Placebo: Placebo for Oxytocin"
11291389|NCT02941692|EG000|Reported Event|Oxytocin|"Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.~Oxytocin"
11291390|NCT02941692|EG001|Reported Event|Placebo|"Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.~Placebo: Placebo for Oxytocin"
11291391|NCT02942160|BG000|Baseline|EN3835 Treatment Regions|Buttock & Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
11291392|NCT02942160|FG000|Participant Flow|EN3835 Treated Participants in EN3835-202|"Observation Phase (259 Started & 222 Completed):~Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201~EN3835 Treated Participants in EN3835-202:~Buttock & Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum"
11291393|NCT02942160|OG000|Outcome|EN3835 Treatment Regions|Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
11291394|NCT02942160|OG000|Outcome|EN3835 0.84 mg|Treatment in Study EN3835-201
11291395|NCT02942160|OG001|Outcome|Placebo|Placebo in Study EN3835-201
11291396|NCT02942160|OG000|Outcome|EN3835 Treatment Regions|Buttocks & Thighs Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
11291397|NCT02942160|EG000|Reported Event|Observation Phase|Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201
11291398|NCT02942160|EG001|Reported Event|EN3835 Treatment Phase|Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
11291399|NCT02942264|BG000|Baseline|ARM 1 Dose Level 0 - (Starting Dose)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291400|NCT02942264|BG001|Baseline|ARM 1 Dose Level 1 - (Dose Escalation)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291401|NCT02942264|BG002|Baseline|ARM 2 Dose Level 0 (Starting Dose)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291402|NCT02942264|BG003|Baseline|ARM 2 Dose 1 - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291403|NCT02942264|BG004|Baseline|ARM 2 Dose 0 - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291404|NCT02942264|BG005|Baseline|ARM 2 Dose Level II - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 300mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291405|NCT02942264|BG006|Baseline|ARM 2 Dose Level I - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291406|NCT02942264|BG007|Baseline|ARM 1 Dose Level 1 (MTD Level in ARM1)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291407|NCT02942264|BG008|Baseline|ARM 2 Dose Level 1 (MTD Level in ARM2)|Temozolomide (TMZ) 50mg/m^2 Daily and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291408|NCT02942264|BG009|Baseline|Total|Total of all reporting groups
11291409|NCT02942264|FG000|Participant Flow|ARM 1 Dose Level 0 - (Starting Dose)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291410|NCT02942264|FG001|Participant Flow|ARM 1 Dose Level 1 - (Dose Escalation)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291411|NCT02942264|FG002|Participant Flow|ARM 2 Dose Level 0 (Starting Dose)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291412|NCT02942264|FG003|Participant Flow|ARM 2 Dose 1 - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291413|NCT02942264|FG004|Participant Flow|ARM 2 Dose 0 - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291414|NCT02942264|FG005|Participant Flow|ARM 2 Dose Level II - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 300mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291415|NCT02942264|FG006|Participant Flow|ARM 2 Dose Level I - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291416|NCT02942264|FG007|Participant Flow|ARM 1 Dose Level 1 (MTD Level in ARM1)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291417|NCT02942264|FG008|Participant Flow|ARM 2 Dose Level 1 (MTD Level in ARM2)|Temozolomide (TMZ) 50mg/m^2 Daily and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291418|NCT02942264|OG000|Outcome|All Participants|All participants in ARM 1 in MTD finding stage: Phase (Ph) I Arm 1 Dose Level (DL) 0, and Ph I Arm 1 DL1.
11291419|NCT02942264|OG000|Outcome|All Participants|All participants in ARM2 in MTD finding stage: Phase (Ph) I Arm 2 DL0, Ph I Arm 2 DL1, Ph I Arm 2 Dose 0, Ph I Arm 2 DLII and Ph I DLI.
10842463|NCT00246519|EG001|Reported Event|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
10842464|NCT00246571|BG000|Baseline|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
10842465|NCT00246571|BG001|Baseline|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
10842466|NCT00246571|BG002|Baseline|Total|Total of all reporting groups
10842467|NCT00246571|FG000|Participant Flow|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
10842468|NCT00246571|FG001|Participant Flow|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
10842469|NCT00246571|OG000|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
10842470|NCT00246571|OG001|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
10842471|NCT00246571|EG000|Reported Event|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
11291420|NCT02942264|OG000|Outcome|All Participants|13 participants in the ARM1 MTD finding stage and 6 participants in the cohort expansion stage: Phase (Ph) I Arm 1 Dose Level (DL) 1
11291421|NCT02942264|OG000|Outcome|All Participants|13 participants in the ARM 2 MTD finding stage and 7 participants in the cohort expansion stage: Phase (Ph) I Arm 2 DL1.
11291422|NCT02942264|OG000|Outcome|Phase II|All participants in phase II.
11291423|NCT02942264|OG000|Outcome|ARM 1 Dose Level 0 - (Starting Dose)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291424|NCT02942264|OG001|Outcome|ARM 1 Dose Level 1 - (Dose Escalation)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291425|NCT02942264|OG002|Outcome|ARM 2 Dose Level 0 (Starting Dose)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291426|NCT02942264|OG003|Outcome|ARM 2 Dose 1 - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291427|NCT02942264|OG004|Outcome|ARM 2 Dose 0 - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291428|NCT02942264|OG005|Outcome|ARM 2 Dose Level II - (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 300mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291429|NCT02942264|OG006|Outcome|ARM 2 Dose Level I - (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291430|NCT02942264|OG007|Outcome|ARM 1 Dose Level 1 (MTD Level in ARM1)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291431|NCT02942264|OG008|Outcome|ARM 2 Dose Level 1 (MTD Level in ARM2)|Temozolomide (TMZ) 50mg/m^2 Daily and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291432|NCT02942264|EG000|Reported Event|ARM 1 Dose Level 0 (Starting Dose)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291433|NCT02942264|EG001|Reported Event|ARM 1 Dose Level 1 (Dose Escalation)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291434|NCT02942264|EG002|Reported Event|ARM 2 Dose Level 0 (Starting Dose)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291435|NCT02942264|EG003|Reported Event|ARM 2 Dose 1 (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291436|NCT02942264|EG004|Reported Event|ARM 2 Dose 0 (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 200mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
10822209|NCT00075270|OG000|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10970946|NCT00912990|EG001|Reported Event|Normal Saline|"Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg~Normal saline : One Intravenous dose"
11291437|NCT02942264|EG005|Reported Event|ARM 2 Dose Level II (Dose Escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 300mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291438|NCT02942264|EG006|Reported Event|ARM 2 Dose Level I (Dose De-escalation)|Temozolomide (TMZ) 50mg/m^2 Daily; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291439|NCT02942264|EG007|Reported Event|ARM 1 Dose Level 1 (MTD Level in ARM1)|Temozolomide (TMZ) 125mg/m^2/day, 7 days on and 7 days off; and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291440|NCT02942264|EG008|Reported Event|ARM 2 Dose Level 1 (MTD Level in ARM2)|Temozolomide (TMZ) 50mg/m^2 Daily and Zotiraciclib (TG02) 250mg/day on day 1,12,15, 26 per 28-day cycle and one extra dose given 3 days prior to Day 1 cycle 1.
11291441|NCT02942407|BG000|Baseline|Apixaban|"apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)~apixaban: oral anticoagulant"
11291442|NCT02942407|BG001|Baseline|Warfarin|"warfarin daily dose adjusted to target International Normalized Ratio (INR) of 2-3~warfarin: oral anticoagulant"
11291443|NCT02942407|BG002|Baseline|Total|Total of all reporting groups
11291444|NCT02942407|FG000|Participant Flow|Apixaban|"apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients; >= 80 years old or dry body weight/hemodialysis target body weight <= 60 kg)~apixaban: oral anticoagulant"
11291445|NCT02942407|FG001|Participant Flow|Warfarin|"warfarin as prescribed by participant's provider dose adjusted to target International Normalized Ratio (INR) of 2-3~warfarin: oral anticoagulant"
11291446|NCT02942407|OG000|Outcome|Apixaban|"apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients; >= 80 years old or dry body weight/hemodialysis target body weight <= 60 kg)~apixaban: oral anticoagulant"
11291447|NCT02942407|OG001|Outcome|Warfarin|"warfarin as prescribed by participant's provider dose adjusted to target International Normalized Ratio (INR) of 2-3~warfarin: oral anticoagulant"
11291448|NCT02942407|OG000|Outcome|Apixaban 2.5 mg|Plasma apixaban concentration, Cmax for apixaban 2.5 mg
11291449|NCT02942407|OG001|Outcome|Apixaban 5 mg|Plasma apixaban concentration, Cmax for apixaban 5mg
11291450|NCT02942407|OG000|Outcome|Apixaban 2.5 mg|Plasma apixaban concentration, Cmin from apixaban 2.5 mg
11291451|NCT02942407|OG001|Outcome|Apixaban 5mg|Plasma apixaban concentration, Cmin from apixaban 5 mg
11291452|NCT02942407|OG000|Outcome|Apixaban 2.5 mg|Plasma apixaban concentration curve from 0 to 12 hours after dose for apixaban 2.5 mg
11291453|NCT02942407|OG001|Outcome|Apixaban 5mg|Plasma apixaban concentration curve from 0 to 12 hours after dose for apixaban 5 mg
11291454|NCT02942407|OG000|Outcome|Apixaban|"apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)~apixaban: oral anticoagulant"
11291455|NCT02942407|OG001|Outcome|Warfarin|"warfarin daily dose adjusted to target International Normalized Ratio (INR) of 2-3~warfarin: oral anticoagulant"
11291456|NCT02942407|EG000|Reported Event|Apixaban|"apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients; >= 80 years old or dry body weight/hemodialysis target body weight <= 60 kg)~apixaban: oral anticoagulant"
11291457|NCT02942407|EG001|Reported Event|Warfarin|"warfarin daily dose adjusted to target International Normalized Ratio (INR) of 2-3~warfarin: oral anticoagulant"
11291458|NCT02942485|BG000|Baseline|Metronidazole|"Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.~Metronidazole: P/r suppositories"
11291459|NCT02942485|BG001|Baseline|Tinidazole|"Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose~Tinidazole: P/o tablets"
11291460|NCT02942485|BG002|Baseline|Total|Total of all reporting groups
11291461|NCT02942485|FG000|Participant Flow|Metronidazole|"Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.~Metronidazole: P/r suppositories"
11291462|NCT02942485|FG001|Participant Flow|Tinidazole|"Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose~Tinidazole: P/o tablets"
11291463|NCT02942485|OG000|Outcome|Metronidazole|"Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.~Metronidazole: P/r suppositories"
11291464|NCT02942485|OG001|Outcome|Tinidazole|"Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose~Tinidazole: P/o tablets"
11291465|NCT02942485|EG000|Reported Event|Metronidazole|"Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.~Metronidazole: P/r suppositories"
11291466|NCT02942485|EG001|Reported Event|Tinidazole|"Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose~Tinidazole: P/o tablets"
11291467|NCT02942576|BG000|Baseline|Edoxaban-based Regimen|"Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.~Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects."
11291468|NCT02942576|BG001|Baseline|VKA-based Regimen|"VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)~VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdon (UK), Taiwan and Korea.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain."
11291469|NCT02942576|BG002|Baseline|Total|Total of all reporting groups
11291470|NCT02942576|FG000|Participant Flow|Edoxaban-based Regimen|"Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.~Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects."
11291471|NCT02942576|FG001|Participant Flow|VKA-based Regimen|"VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)~VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain."
11291472|NCT02942576|OG000|Outcome|Edoxaban-based Regimen|"Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.~Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects."
11291473|NCT02942576|OG001|Outcome|VKA-based Regimen|"VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)~VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain."
11291474|NCT02942576|EG000|Reported Event|Edoxaban-based Regimen|"Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.~Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects."
11291475|NCT02942576|EG001|Reported Event|VKA-based Regimen|"VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)~VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.~VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain."
11291476|NCT02942654|BG000|Baseline|Overall Study|Each participant was administered with 15 U dose of LY900014 and Insulin Lispro.
11291477|NCT02942654|FG000|Participant Flow|Sequence 1|A single 15U dose of LY900014 or Insulin Lispro was administered subcutaneously (SC) as per the dosing schedule (Period 1: LY900014 ; Period 2: Insulin Lispro).
11291478|NCT02942654|FG001|Participant Flow|Sequence 2|A single 15U dose of Insulin Lispro or LY900014 was administered subcutaneously (SC) as per the dosing schedule (Period 1: Insulin Lispro; Period 2: LY900014).
11291479|NCT02942654|OG000|Outcome|LY900014|15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.
11291480|NCT02942654|OG001|Outcome|Insulin Lispro|15-U dose of Insulin Lispro administered SC in one of two periods.
11291481|NCT02942654|EG000|Reported Event|LY900014|15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.
11291482|NCT02942654|EG001|Reported Event|Insulin Lispro|15-U dose of Insulin Lispro administered SC in one of two periods.
11291483|NCT02942771|BG000|Baseline|Placebo|"No drug intervention.~Placebo: 0.9% sodium chloride"
11291484|NCT02942771|BG001|Baseline|Cohort 1 - TT301/MW189|"TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 1 - TT301/MW189: 0.075 mg/kg IV twice daily on Days 1 through 5"
11291485|NCT02942771|BG002|Baseline|Cohort 2 -TT301/MW189|"TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 2- TT301MW189: 0.15 mg/kg IV twice daily on Days 1 through 5"
11291486|NCT02942771|BG003|Baseline|Cohort 3- TT301/MW189|"TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 3 - TT301/MW189: 0.25 mg/kg IV twice daily on Days 1 through 5"
11291487|NCT02942771|BG004|Baseline|Cohort 4- TT301/MW189|"TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 4 - TT301/MW189: 0.30 mg/kg IV twice daily on Days 1 through 5"
11291488|NCT02942771|BG005|Baseline|Total|Total of all reporting groups
11291489|NCT02942771|FG000|Participant Flow|Placebo|"No drug intervention.~Placebo: 0.9% sodium chloride"
11291490|NCT02942771|FG001|Participant Flow|Cohort 1 - TT301/MW189|"TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 1 - TT301/MW189: 0.075 mg/kg IV twice daily on Days 1 through 5"
11291491|NCT02942771|FG002|Participant Flow|Cohort 2 -TT301/MW189|"TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 2- TT301MW189: 0.15 mg/kg IV twice daily on Days 1 through 5"
11291492|NCT02942771|FG003|Participant Flow|Cohort 3- TT301/MW189|"TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 3 - TT301/MW189: 0.25 mg/kg IV twice daily on Days 1 through 5"
11291493|NCT02942771|FG004|Participant Flow|Cohort 4- TT301/MW189|"TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 4 - TT301/MW189: 0.30 mg/kg IV twice daily on Days 1 through 5"
11291494|NCT02942771|OG000|Outcome|Placebo|"No drug intervention.~Placebo: 0.9% sodium chloride"
11291495|NCT02942771|OG001|Outcome|Cohort 1 - TT301/MW189|"TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 1 - TT301/MW189: 0.075 mg/kg IV twice daily on Days 1 through 5"
11291496|NCT02942771|OG002|Outcome|Cohort 2 -TT301/MW189|"TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 2- TT301MW189: 0.15 mg/kg IV twice daily on Days 1 through 5"
11291497|NCT02942771|OG003|Outcome|Cohort 3- TT301/MW189|"TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 3 - TT301/MW189: 0.25 mg/kg IV twice daily on Days 1 through 5"
11291498|NCT02942771|OG004|Outcome|Cohort 4- TT301/MW189|"TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 4 - TT301/MW189: 0.30 mg/kg IV twice daily on Days 1 through 5"
11291499|NCT02942771|EG000|Reported Event|Placebo|"No drug intervention.~Placebo: 0.9% sodium chloride"
11291500|NCT02942771|EG001|Reported Event|Cohort 1 - TT301/MW189|"TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 1 - TT301/MW189: 0.075 mg/kg IV twice daily on Days 1 through 5"
11291501|NCT02942771|EG002|Reported Event|Cohort 2 -TT301/MW189|"TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 2- TT301MW189: 0.15 mg/kg IV twice daily on Days 1 through 5"
11291502|NCT02942771|EG003|Reported Event|Cohort 3- TT301/MW189|"TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 3 - TT301/MW189: 0.25 mg/kg IV twice daily on Days 1 through 5"
11291503|NCT02942771|EG004|Reported Event|Cohort 4- TT301/MW189|"TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive~Cohort 4 - TT301/MW189: 0.30 mg/kg IV twice daily on Days 1 through 5"
11291504|NCT02942979|BG000|Baseline|MISSION Implementation as Usual|Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies
11291505|NCT02942979|BG001|Baseline|Facilitation Implementation of MISSION|Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity.
11291506|NCT02942979|BG002|Baseline|Total|Total of all reporting groups
11291507|NCT02942979|FG000|Participant Flow|MISSION Implementation as Usual|Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies
11291508|NCT02942979|FG001|Participant Flow|Facilitation Implementation of MISSION|Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity.
11291509|NCT02942979|OG000|Outcome|MISSION Implementation as Usual|Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies
11291510|NCT02942979|OG001|Outcome|Facilitation Implementation of MISSION|Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity.
11291511|NCT02942979|EG000|Reported Event|MISSION Implementation as Usual|Passive implementation or, IU for MISSION-Vet is comprised of a two-hour webinar training, along with key information on how to access and use the MISSION-Vet Treatment Manual and Consumer Workbook. The manual is posted on the web and available inside the VA on the National Center for Homelessness Among Veterans website or at missionmode.org. This passive implementation strategy has been used in previous studies
11291512|NCT02942979|EG001|Reported Event|Facilitation Implementation of MISSION|Facilitation is a comprehensive approach in which implementation experts partner with local staff to support implementation planning and to tailor adoption strategies to the local context. Facilitation gives attention to addressing individual- and organizational-level factors that can influence successful implementation of an evidence based practice with good fidelity.
11291513|NCT02943070|BG000|Baseline|Rezum Treatment|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291514|NCT02943070|FG000|Participant Flow|Rezum Treatment|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291515|NCT02943070|OG000|Outcome|Rezum Treatment|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291516|NCT02943070|OG000|Outcome|Rezum Treatment - Larger Prostates (≥35gm)|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
10822210|NCT00075270|OG001|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10822211|NCT00075270|OG000|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
10970947|NCT00913003|BG000|Baseline|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
11291517|NCT02943070|OG001|Outcome|Rezum Treatment - Smaller Prostates (<35g)|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291518|NCT02943070|OG000|Outcome|Rezum Treatment - No Median Lobe Present (Lateral Lobes Treated)|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291519|NCT02943070|OG001|Outcome|Rezum Treatment - Median Lobe Present (Lateral and Median Lobes Treated)|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291520|NCT02943070|OG000|Outcome|Subjects With Baseline IPSS 13-19|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291521|NCT02943070|OG001|Outcome|Subjects With Baseline IPSS 20-25|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291522|NCT02943070|OG002|Outcome|Subjects With Baseline IPSS 26-35|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291523|NCT02943070|EG000|Reported Event|Rezum Treatment|"Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.~Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
11291524|NCT02943096|BG000|Baseline|Flavanol|"Blinded treatment with either CocoaVia 500mg or placebo.~CocoaVia: Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa."
11291525|NCT02943096|BG001|Baseline|Placebo|"Blinded treatment with either CocoaVia 500mg or placebo.~Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a sugar pill)."
11291526|NCT02943096|BG002|Baseline|Total|Total of all reporting groups
11291527|NCT02943096|FG000|Participant Flow|Flavanol|"Blinded treatment with either CocoaVia 500mg or placebo.~CocoaVia: Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa."
11291528|NCT02943096|FG001|Participant Flow|Placebo|"Blinded treatment with either CocoaVia 500mg or placebo.~Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a sugar pill)."
11291529|NCT02943096|OG000|Outcome|Flavanol|"Blinded treatment with either CocoaVia 500mg or placebo.~CocoaVia: Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa."
11291530|NCT02943096|OG001|Outcome|Placebo|"Blinded treatment with either CocoaVia 500mg or placebo.~Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a sugar pill)."
11291531|NCT02943096|EG000|Reported Event|Flavanol|"Blinded treatment with either CocoaVia 500mg or placebo.~CocoaVia: Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa."
11291532|NCT02943096|EG001|Reported Event|Placebo|"Blinded treatment with either CocoaVia 500mg or placebo.~Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a sugar pill)."
11291533|NCT02943213|BG000|Baseline|Chlorpromazine 25 mg|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
11291534|NCT02943213|FG000|Participant Flow|Chlorpromazine 25 mg|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
11291535|NCT02943213|OG000|Outcome|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
11291536|NCT02943213|OG001|Outcome|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
11291537|NCT02943213|EG000|Reported Event|Treatment Period 1|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc."
11291538|NCT02943213|EG001|Reported Event|Treatment Period 2|"All enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.~Chlorpromazine Hydrochloride: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc"
11291539|NCT02943226|BG000|Baseline|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
11291540|NCT02943226|BG001|Baseline|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
11291541|NCT02943226|BG002|Baseline|Total|Total of all reporting groups
11291542|NCT02943226|FG000|Participant Flow|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
11291543|NCT02943226|FG001|Participant Flow|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
11291544|NCT02943226|OG000|Outcome|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
11291545|NCT02943226|OG001|Outcome|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
11291546|NCT02943226|EG000|Reported Event|Becton Dickinson Nexiva Diffusics System Fenestrated Catheter|Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.
11291547|NCT02943226|EG001|Reported Event|Standard Intravenous Non-fenestrated Catheter|The standard catheter has one hole at the tip for contrast infusion.
11291548|NCT02943447|BG000|Baseline|Cilofexor 100 mg|"Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.~Open Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks."
11291549|NCT02943447|BG001|Baseline|Cilofexor 30 mg|"Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.~OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks."
11291550|NCT02943447|BG002|Baseline|Placebo|"Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.~OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks."
11291551|NCT02943447|BG003|Baseline|Total|Total of all reporting groups
11291552|NCT02943447|FG000|Participant Flow|Cilofexor 100 mg|"Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.~Open-Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks."
11291553|NCT02943447|FG001|Participant Flow|Cilofexor 30 mg|"Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.~OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks."
11291554|NCT02943447|FG002|Participant Flow|Placebo|"Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.~OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks."
11291555|NCT02943447|OG000|Outcome|Blinded Study Phase: Cilofexor 100 mg|Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
11291556|NCT02943447|OG001|Outcome|Blinded Study Phase: Cilofexor 30 mg|Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
11291557|NCT02943447|OG002|Outcome|Blinded Study Phase: Placebo|Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
11291558|NCT02943447|OG000|Outcome|OLE Phase: From Cilofexor 100 mg|OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
11291559|NCT02943447|OG001|Outcome|OLE Phase: From Cilofexor 30 mg|OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
10970948|NCT00913003|BG001|Baseline|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
10970949|NCT00913003|BG002|Baseline|Total|Total of all reporting groups
11291560|NCT02943447|OG002|Outcome|OLE Phase: From Placebo|OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
11291561|NCT02943447|OG000|Outcome|OLE Phase: From Cilofexor 100 mg|OLE Phase: Following Blinded Study Phase, participants in cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
11291562|NCT02943447|OG001|Outcome|OLE Phase: From Cilofexor 30 mg|OLE Phase: Following Blinded Study Phase, participants in cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
11291563|NCT02943447|OG002|Outcome|OLE Phase: From Placebo|OLE Phase: Following Blinded Study Phase, participants in placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
11291564|NCT02943447|EG000|Reported Event|Blinded Study Phase: Cilofexor 100 mg|Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
11291565|NCT02943447|EG001|Reported Event|Blinded Study Phase: Cilofexor 30 mg|Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
11291566|NCT02943447|EG002|Reported Event|Blinded Study Phase: Placebo|Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
10970950|NCT00913003|FG000|Participant Flow|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
10970951|NCT00913003|FG001|Participant Flow|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
11291567|NCT02943447|EG003|Reported Event|OLE Phase: From Cilofexor 100 mg|OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
11291568|NCT02943447|EG004|Reported Event|OLE Phase: From Cilofexor 30 mg|OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
11291569|NCT02943447|EG005|Reported Event|OLE Phase: From Placebo|OLE Phase: Following Blinded Study Phase, participants in the Placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
11291570|NCT02943460|BG000|Baseline|Cilofexor 100 mg|Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily with food for up to 12.6 weeks
11291571|NCT02943460|BG001|Baseline|Cilofexor 30 mg|Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.7 weeks
11291572|NCT02943460|BG002|Baseline|Placebo|Placebo to match cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.3 weeks
11291573|NCT02943460|BG003|Baseline|Total|Total of all reporting groups
11291574|NCT02943460|FG000|Participant Flow|Cilofexor 100 mg|"Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily with food for up to 12.6 weeks~Open Label Extension Phase: Cilofexor 100 mg tablet orally once daily with food for an additional up to 97.4 weeks"
10970952|NCT00913003|OG000|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
11291575|NCT02943460|FG001|Participant Flow|Cilofexor 30 mg|"Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.7 weeks~Open Label Extension Phase: Cilofexor 100 mg tablet orally once daily with food for an additional up to 97 weeks"
11291576|NCT02943460|FG002|Participant Flow|Placebo|"Blinded Study Phase: Placebo to match cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.3 weeks~Open Label Extension Phase: Cilofexor 100 mg tablet orally once daily with food for an additional up to 97 weeks"
11291577|NCT02943460|OG000|Outcome|Cilofexor 100 mg|Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily with food for up to 12.6 weeks
11291578|NCT02943460|OG001|Outcome|Cilofexor 30 mg|Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.7 weeks
11291579|NCT02943460|OG002|Outcome|Placebo|Placebo to match cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.3 weeks
11291580|NCT02943460|EG000|Reported Event|Cilofexor 100 mg (Blinded Phase)|Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily with food for up to 12.6 weeks
11291581|NCT02943460|EG001|Reported Event|Cilofexor 30 mg (Blinded Phase)|Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.7 weeks
11291582|NCT02943460|EG002|Reported Event|Placebo (Blinded Phase)|Placebo to match cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.3 weeks
11291583|NCT02943460|EG003|Reported Event|Cilofexor 100 mg (Open Label Extension Phase)|Following the Blinded Phase, eligible participants received cilofexor 100 mg tablet orally once daily for an additional up to 97.4 weeks
11291584|NCT02943473|BG000|Baseline|Ibrutinib|"Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose administered on a continuous basis~Ibrutinib: Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing."
11291585|NCT02943473|FG000|Participant Flow|Ibrutinib|"Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose taken PO daily for 12 cycles (28 days each).~Ibrutinib: Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing."
11291586|NCT02943473|OG000|Outcome|Ibrutinib|"Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose administered on a continuous basis~Ibrutinib: Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing."
11291587|NCT02943473|EG000|Reported Event|Ibrutinib|"Ibrutinib (trademark name is IMBRUVICA®). 560 mg dose administered on a continuous basis~Ibrutinib: Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing."
10970953|NCT00913003|OG001|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
10970954|NCT00913003|EG000|Reported Event|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
11291588|NCT02943499|BG000|Baseline|Active Comparator App/Training|"This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.~App/Training: This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones~Smartphone"
11291589|NCT02943499|BG001|Baseline|Experimental App/Training|"This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.~App/Training: It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.~Smartphone"
11291590|NCT02943499|BG002|Baseline|Total|Total of all reporting groups
11336324|NCT03565068|EG012|Reported Event|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11336325|NCT03565068|EG013|Reported Event|Panel B (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18
11336326|NCT03565068|EG014|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11291591|NCT02943499|FG000|Participant Flow|Active Comparator App/Training|"This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.~App/Training: This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones~Smartphone"
11291592|NCT02943499|FG001|Participant Flow|Experimental App/Training|"This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.~App/Training: It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.~Smartphone"
11291593|NCT02943499|OG000|Outcome|Active Comparator App/Training|"This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.~App/Training: This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones~Smartphone"
11291594|NCT02943499|OG001|Outcome|Experimental App/Training|"This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.~App/Training: It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.~Smartphone"
11291595|NCT02943499|EG000|Reported Event|Active Comparator App/Training|"This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.~App/Training: This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones~Smartphone"
11291596|NCT02943499|EG001|Reported Event|Experimental App/Training|"This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.~App/Training: It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.~Smartphone"
11291597|NCT02943564|BG000|Baseline|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291598|NCT02943564|BG001|Baseline|Rapastinel 225 mg|Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291599|NCT02943564|BG002|Baseline|Rapastinel 450 mg|Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291600|NCT02943564|BG003|Baseline|Total|Total of all reporting groups
11291601|NCT02943564|FG000|Participant Flow|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291602|NCT02943564|FG001|Participant Flow|Rapastinel 225 mg|Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291603|NCT02943564|FG002|Participant Flow|Rapastinel 450 mg|Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291604|NCT02943564|OG000|Outcome|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291605|NCT02943564|OG001|Outcome|Rapastinel 225 mg|Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291606|NCT02943564|OG002|Outcome|Rapastinel 450 mg|Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291607|NCT02943564|EG000|Reported Event|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291608|NCT02943564|EG001|Reported Event|Rapastinel 225 mg|Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291609|NCT02943564|EG002|Reported Event|Rapastinel 450 mg|Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291610|NCT02943577|BG000|Baseline|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291611|NCT02943577|BG001|Baseline|Rapastinel 450 mg|Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291612|NCT02943577|BG002|Baseline|Total|Total of all reporting groups
11291613|NCT02943577|FG000|Participant Flow|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291614|NCT02943577|FG001|Participant Flow|Rapastinel 450 mg|Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291615|NCT02943577|OG000|Outcome|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291616|NCT02943577|OG001|Outcome|Rapastinel 450 mg|Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291617|NCT02943577|EG000|Reported Event|Placebo|Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291618|NCT02943577|EG001|Reported Event|Rapastinel 450 mg|Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
11291619|NCT02943668|BG000|Baseline|Treatment (Deferasirox)|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291620|NCT02943668|FG000|Participant Flow|Treatment (Deferasirox)|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291621|NCT02943668|OG000|Outcome|Treatment (Deferasirox)|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies~Of the two participants on the study, none achieved erythroid hematologic improvement as defined by the modified IWG response criteria at 6 months."
11291622|NCT02943668|OG000|Outcome|Patient 1|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291623|NCT02943668|OG001|Outcome|Patient 2|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291624|NCT02943668|OG000|Outcome|Treatment (Deferasirox)|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291625|NCT02943668|EG000|Reported Event|Treatment (Deferasirox)|"Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~Deferasirox: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11291626|NCT02943941|BG000|Baseline|Single Arm|Single arm
11291627|NCT02943941|FG000|Participant Flow|Single Arm Design|Single arm (all participants)
11291628|NCT02943941|OG000|Outcome|Single Arm Design|Single arm
11291629|NCT02943941|OG000|Outcome|Single Arm|Single arm
11291630|NCT02943941|EG000|Reported Event|Single Arm|Single arm
11291631|NCT02944383|BG000|Baseline|Gemcabene 600 mg|Participants received 600 mg Gemcabene orally, once daily for 12 weeks.
11291632|NCT02944383|BG001|Baseline|Gemcabene 300 mg|Participants received 300 mg Gemcabene orally, once daily for 12 weeks.
11291633|NCT02944383|BG002|Baseline|Placebo|Participants received matching placebo orally, once daily for 12 weeks.
11291634|NCT02944383|BG003|Baseline|Total|Total of all reporting groups
11291635|NCT02944383|FG000|Participant Flow|Gemcabene 600 mg|Participants received 600 milligram (mg) Gemcabene orally, once daily for 12 weeks.
11291636|NCT02944383|FG001|Participant Flow|Gemcabene 300 mg|Participants received 300 mg Gemcabene orally, once daily for 12 weeks.
11291637|NCT02944383|FG002|Participant Flow|Placebo|Participants received matching placebo orally, once daily for 12 weeks.
11291638|NCT02944383|OG000|Outcome|Gemcabene 600 mg|Participants received 600 mg Gemcabene orally, once daily for 12 weeks.
11291639|NCT02944383|OG001|Outcome|Gemcabene 300 mg|Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.
11291640|NCT02944383|OG002|Outcome|Placebo|Participants received matching placebo orally, once daily for 12 weeks.
11291641|NCT02944383|OG000|Outcome|Gemcabene 600 mg|Participants received 600 mg of Gemcabene orally, once daily for 12 weeks.
11291642|NCT02944383|OG002|Outcome|Placebo|Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.
11291643|NCT02944383|EG000|Reported Event|Gemcabene 600 mg|Participants received 600 mg Gemcabene orally, once daily for 12 weeks.
11291644|NCT02944383|EG001|Reported Event|Gemcabene 300 mg|Participants received 300 mg Gemcabene orally, once daily for 12 weeks.
11291645|NCT02944383|EG002|Reported Event|Placebo|Participants received matching placebo orally, once daily for 12 weeks.
11291646|NCT02944448|BG000|Baseline|CR845 Tablet|Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
11291647|NCT02944448|BG001|Baseline|Placebo Tablet|Twice daily dosing (BID)
11291648|NCT02944448|BG002|Baseline|Total|Total of all reporting groups
11291649|NCT02944448|FG000|Participant Flow|CR845 Tablet|Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
11291650|NCT02944448|FG001|Participant Flow|Placebo Tablet|Twice daily dosing (BID)
11291651|NCT02944448|OG000|Outcome|CR845 Tablet|"Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.~During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion."
11291652|NCT02944448|OG001|Outcome|Placebo Tablet|Twice daily dosing (BID)
11291653|NCT02944448|OG000|Outcome|CR845 Tablet|Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
11291654|NCT02944448|EG000|Reported Event|CR845 Tablet|Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
11291655|NCT02944448|EG001|Reported Event|Placebo Tablet|"Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.~Placebo tablet: Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment."
10970955|NCT00913003|EG001|Reported Event|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
11291656|NCT02944461|BG000|Baseline|Dapsone Gel 7.5%|"Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.~Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne"
11291657|NCT02944461|FG000|Participant Flow|Dapsone Gel 7.5%|"Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.~Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne"
11291658|NCT02944461|OG000|Outcome|Dapsone Gel 7.5%|"Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.~Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne"
11291659|NCT02944461|EG000|Reported Event|Dapsone Gel 7.5%|"Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.~Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne"
11291660|NCT02944565|BG000|Baseline|Treatment (Daratumumab)|Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
11291661|NCT02944565|FG000|Participant Flow|Treatment (Daratumumab)|Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
11291662|NCT02944565|OG000|Outcome|Treatment (Daratumumab)|Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
11291663|NCT02944565|OG000|Outcome|Treatment (Daratumumab)|"Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.~Daratumumab: Given IV"
11291664|NCT02944565|EG000|Reported Event|Treatment (Daratumumab)|Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
11291665|NCT02944656|BG000|Baseline|Gabapentin Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
11291666|NCT02944656|BG001|Baseline|Placebo Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
11291667|NCT02944656|BG002|Baseline|Total|Total of all reporting groups
11291668|NCT02944656|FG000|Participant Flow|Gabapentin Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
11291669|NCT02944656|FG001|Participant Flow|Placebo Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
11291670|NCT02944656|OG000|Outcome|Gabapentin Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
11291671|NCT02944656|OG001|Outcome|Placebo Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
11291672|NCT02944656|EG000|Reported Event|Gabapentin Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
11291673|NCT02944656|EG001|Reported Event|Placebo Group|Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
11291674|NCT02944968|BG000|Baseline|THERMOCOOL SMARTTOUCH® SF-5D|The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
11291675|NCT02944968|FG000|Participant Flow|THERMOCOOL SMARTTOUCH® SF-5D|The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
11291676|NCT02944968|OG000|Outcome|THERMOCOOL SMARTTOUCH® SF-5D|The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
11291677|NCT02944968|EG000|Reported Event|THERMOCOOL SMARTTOUCH® SF-5D|The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
11291678|NCT02945046|BG000|Baseline|Placebo|Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
11291679|NCT02945046|BG001|Baseline|Fremanezumab 675 mg/Placebo/Placebo|Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291680|NCT02945046|BG002|Baseline|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291681|NCT02945046|BG003|Baseline|Total|Total of all reporting groups
11291682|NCT02945046|FG000|Participant Flow|Placebo|Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
11291683|NCT02945046|FG001|Participant Flow|Fremanezumab 675 mg/Placebo/Placebo|Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 milligrams (mg) administered as 3 subcutaneous injections (225 mg/1.5 milliliters [mL]) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291684|NCT02945046|FG002|Participant Flow|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291685|NCT02945046|OG000|Outcome|Placebo|Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
11291686|NCT02945046|OG001|Outcome|Fremanezumab 675 mg/Placebo/Placebo|Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291687|NCT02945046|OG002|Outcome|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291688|NCT02945046|EG000|Reported Event|Placebo|Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
10970956|NCT00913068|BG000|Baseline|TAP Arm|in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm
11215970|NCT02302807|OG004|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
11215971|NCT02302807|OG005|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215972|NCT02302807|OG000|Outcome|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
11215973|NCT02302807|OG001|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215974|NCT02302807|OG002|Outcome|IC2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215975|NCT02302807|OG003|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215976|NCT02302807|OG004|Outcome|IC1/2/3 Chemotherapy|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
11215977|NCT02302807|OG005|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC1/2/3
11215978|NCT02302807|OG000|Outcome|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215979|NCT02302807|OG001|Outcome|IC1/2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215980|NCT02302807|OG002|Outcome|IC2/3 Atezolizumab|PD-L1 immunohistochemistry (IHC) score of IC2/3
11215981|NCT02302807|EG000|Reported Event|Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)|Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
11215982|NCT02302807|EG001|Reported Event|Atezolizumab|Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
11215983|NCT02302846|BG000|Baseline|Ixazomib|"Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.~Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle."
11215984|NCT02302846|FG000|Participant Flow|Ixazomib|"Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.~Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle."
11215985|NCT02302846|OG000|Outcome|Ixazomib|"Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.~Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle."
11215986|NCT02302846|EG000|Reported Event|Ixazomib|"Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.~Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle."
11215987|NCT02303041|BG000|Baseline|BCC Smoothened Inhibitor-naive|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) and naive to treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215988|NCT02303041|BG001|Baseline|BCC Refractory or Relapsed After Smoothened Inhibitor|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) that is refractory or relapsed after treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215989|NCT02303041|BG002|Baseline|Total|Total of all reporting groups
11215990|NCT02303041|FG000|Participant Flow|BCC Smoothened Inhibitor-naive|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) and naive to treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215991|NCT02303041|FG001|Participant Flow|BCC Refractory or Relapsed After Smoothened Inhibitor|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) that is refractory or relapsed after treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215992|NCT02303041|OG000|Outcome|BCC Smoothened Inhibitor-naive|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) and naive to treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11291689|NCT02945046|EG001|Reported Event|Fremanezumab 675 mg/Placebo/Placebo|Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291690|NCT02945046|EG002|Reported Event|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
11291691|NCT02945150|BG000|Baseline|Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients|"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."
11291692|NCT02945150|FG000|Participant Flow|Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients|"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."
11291693|NCT02945150|OG000|Outcome|Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients|"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."
11291694|NCT02945150|EG000|Reported Event|Elbasvir/Grazoprevir for HCV+ Kidney Transplant Recipients|"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."
11291695|NCT02945254|BG000|Baseline|Background Noise First, Silence Second|Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise
11291696|NCT02945254|BG001|Baseline|Silence First, Background Noise Second|Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
11291697|NCT02945254|BG002|Baseline|Total|Total of all reporting groups
11291698|NCT02945254|FG000|Participant Flow|Background Noise First, Silence Second|Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise
11291699|NCT02945254|FG001|Participant Flow|Silence First, Background Noise Second|Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
11291700|NCT02945254|OG000|Outcome|Background Noise|Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)
11291701|NCT02945254|OG001|Outcome|Silence|Overnight sleep study with normal environmental noise
11291702|NCT02945254|EG000|Reported Event|Background Noise|Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)
11291703|NCT02945254|EG001|Reported Event|Silence|Overnight sleep study with normal environmental noise
11291704|NCT02945410|BG000|Baseline|(1) CRHP (2) EB (3) CRNP|"In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291705|NCT02945410|BG001|Baseline|(1) CRHP (2) CRNP (3) EB|"In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11332546|NCT03497130|BG000|Baseline|Regimen Group|After 1 week washout period using provided Dove® Soap without any moisturizer, participants in the skin care regimen group will receive Vaseline® Moisturizer, Dove® Soap, and application log. These participants will be asked to apply the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.
11291706|NCT02945410|BG002|Baseline|(1) CRNP (2) EB (3) CRHP|"In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291707|NCT02945410|BG003|Baseline|(1) CRNP (2) CRHP (3) EB|"In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291708|NCT02945410|BG004|Baseline|(1) EB (2) CRHP (3) CRNP|"In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291709|NCT02945410|BG005|Baseline|(1) EB (2) CRNP (3) CRHP|"In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291710|NCT02945410|BG006|Baseline|Total|Total of all reporting groups
11291711|NCT02945410|FG000|Participant Flow|(1) CRHP (2) EB (3) CRNP|"In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291712|NCT02945410|FG001|Participant Flow|(1) CRHP (2) CRNP (3) EB|"In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291713|NCT02945410|FG002|Participant Flow|(1) CRNP (2) EB (3) CRHP|"In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291714|NCT02945410|FG003|Participant Flow|(1) CRNP (2) CRHP (3) EB|"In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11332547|NCT03497130|BG001|Baseline|Control Group|"After 1 week washout period using provided Dove® Soap without any moisturizer, Individuals in the control group will continue with the provided Dove® Soap for 2 weeks.~All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use."
11332548|NCT03497130|BG002|Baseline|Total|Total of all reporting groups
11291715|NCT02945410|FG004|Participant Flow|(1) EB (2) CRHP (3) CRNP|"In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291716|NCT02945410|FG005|Participant Flow|(1) EB (2) CRNP (3) CRHP|"In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.~In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm."
11291717|NCT02945410|OG000|Outcome|Caloric Restriction and High Protein|"Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.~Protein: Participants will consume 1.7 g protein/kg BW/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291718|NCT02945410|OG001|Outcome|Caloric Restriction and Normal Protein|"Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291719|NCT02945410|OG002|Outcome|Energy Balance|"Participants will be in energy balance and consume 1.7 g protein/kg BW/day.~Protein: Participants will consume 1.7 g protein/kg BW/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291720|NCT02945410|EG000|Reported Event|Caloric Restriction and High Protein|"Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.~Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.~Protein: Participants will consume 1.7 g protein/kg BW/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291721|NCT02945410|EG001|Reported Event|Caloric Restriction and Normal Protein|"Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.~Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291722|NCT02945410|EG002|Reported Event|Energy Balance|"Participants will be in energy balance and consume 1.7 g protein/kg BW/day.~Protein: Participants will consume 1.7 g protein/kg BW/day.~Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day~Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms~Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm"
11291723|NCT02945553|BG000|Baseline|NMES|"Neuromuscular electrical stimulation (NMES) group~Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery."
11291724|NCT02945553|BG001|Baseline|Microstimulation|"Microstimulation~Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery."
11291725|NCT02945553|BG002|Baseline|Total|Total of all reporting groups
11291726|NCT02945553|FG000|Participant Flow|NMES|"Neuromuscular electrical stimulation (NMES) group~Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery."
11291727|NCT02945553|FG001|Participant Flow|Microstimulation|"Microstimulation~Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery."
11291728|NCT02945553|OG000|Outcome|NMES|"Neuromuscular electrical stimulation (NMES) group~Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery."
11291729|NCT02945553|OG001|Outcome|Microstimulation|"Microstimulation~Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery."
11291730|NCT02945553|OG000|Outcome|Microstimulation|Sham control group
11215993|NCT02303041|OG001|Outcome|BCC Refractory or Relapsed After Smoothened Inhibitor|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) that is refractory or relapsed after treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215994|NCT02303041|EG000|Reported Event|BCC Smoothened Inhibitor-naive|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) and naive to treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215995|NCT02303041|EG001|Reported Event|BCC Refractory or Relapsed After Smoothened Inhibitor|"Participants with locally advanced or metastatic basal cell carcinoma (BCC) that is refractory or relapsed after treatment with Smoothened inhibitors receive sonidegib and buparlisib in repeating 28-day cycles in the absence of disease progression or unacceptable toxicity.~Buparlisib: Administered orally at starting dose of 80 mg/day~Sonidegib: Administered orally at starting dose of 200 mg/day"
11215996|NCT02303093|BG000|Baseline|All Patients|All patients
11215997|NCT02303093|FG000|Participant Flow|All Patients|All patients
11215998|NCT02303093|OG000|Outcome|Octagam 5%|Octagam 5%
11215999|NCT02303093|OG001|Outcome|Octagam 10%|Octagam 10%
11216000|NCT02303093|OG002|Outcome|Octagam 5% and Octagam 10%, While Under Octagam 5%|Octagam 5% and Octagam 10%, while under Octagam 5%
11216001|NCT02303093|OG003|Outcome|Octagam 5% and Octagam 10%, While Under Octagam 10%|Octagam 5% and Octagam 10%, while under Octagam 10%
11216002|NCT02303093|OG004|Outcome|Octagam 10% and Panzyga, While Under Octagam 10%|Octagam 10% and Panzyga, while under Octagam 10%
11216003|NCT02303093|OG005|Outcome|Octagam 10% and Panzyga, While Under Panzyga|Octagam 10% and Panzyga, while under Panzyga
11216004|NCT02303093|OG002|Outcome|Octagam 5% and Octagam 10%|Panzyga
11216005|NCT02303093|OG003|Outcome|Octagam 10% and Panzyga|Octagam 10% and Panzyga
11216006|NCT02303093|EG000|Reported Event|Octagam 5%|Octagam 5%
11216007|NCT02303093|EG001|Reported Event|Octagam 10%|Octagam 10%
11216008|NCT02303093|EG002|Reported Event|Octagam 5% and Octagam 10%, While Under Octagam 5%|Octagam 5% and Octagam 10%, while under Octagam 5%
11216009|NCT02303093|EG003|Reported Event|Octagam 5% and Octagam 10%, While Under Octagam 10%|Octagam 5% and Octagam 10%, while under Octagam 10%
11216010|NCT02303093|EG004|Reported Event|Octagam 10% and Panzyga, While Under Octagam 10%|Octagam 10% and Panzyga, while under Octagam 10%
11216011|NCT02303093|EG005|Reported Event|Octagam 10% and Panzyga, While Under Panzyga|Octagam 10% and Panzyga, while under Panzyga
11216012|NCT02303184|BG000|Baseline|Suprachoroidal CLS-TA + IVT Aflibercept|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216013|NCT02303184|BG001|Baseline|Suprachoroidal Sham + IVT Aflibercept|"Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216014|NCT02303184|BG002|Baseline|Total|Total of all reporting groups
11216015|NCT02303184|FG000|Participant Flow|Suprachoroidal CLS-TA + IVT Aflibercept|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216016|NCT02303184|FG001|Participant Flow|Suprachoroidal Sham + IVT Aflibercept|"Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216017|NCT02303184|OG000|Outcome|Suprachoroidal CLS-TA + IVT Aflibercept|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216018|NCT02303184|OG001|Outcome|Suprachoroidal Sham + IVT Aflibercept|"Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216019|NCT02303184|EG000|Reported Event|Suprachoroidal CLS-TA + IVT Aflibercept|"Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216020|NCT02303184|EG001|Reported Event|Suprachoroidal Sham + IVT Aflibercept|"Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11216021|NCT02303262|BG000|Baseline|Mocetinostat and Gemcitabine|"For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.~Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.~Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle."
11216022|NCT02303262|FG000|Participant Flow|Mocetinostat and Gemcitabine|"For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.~Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.~Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle."
11216023|NCT02303262|OG000|Outcome|Mocetinostat and Gemcitabine|"For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.~Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.~Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle."
11291731|NCT02945553|OG001|Outcome|Neuromuscular Electrical Stimlulation|Treatment group
11291732|NCT02945553|OG000|Outcome|Microstimulation|Microstimulation: Sham control group
11291733|NCT02945553|OG001|Outcome|Neuromuscular Electrical Stimlulation|Neuromuscular electrical stimulation: Treatment group
11291734|NCT02945553|EG000|Reported Event|Microstimulation|Microstimulation: Sham control group
11291735|NCT02945553|EG001|Reported Event|Neuromuscular Electrical Stimlulation|Neuromuscular electrical stimulation: Treatment group
11291736|NCT02945657|BG000|Baseline|MM36 Topical Ointment, 1%|MM36 topical ointment, 1%, applied twice daily for 28 days
11291737|NCT02945657|FG000|Participant Flow|MM36 Topical Ointment, 1%|MM36 topical ointment, 1%, applied twice daily for 28 days
11291738|NCT02945657|OG000|Outcome|MM36 Topical Ointment, 1%|MM36 topical ointment, 1%, applied twice daily for 15 days
11291739|NCT02945657|OG000|Outcome|MM36 Topical Ointment, 1%|MM36 topical ointment, 1%, applied twice daily for 28 days
11291740|NCT02945657|EG000|Reported Event|MM36 Topical Ointment, 1%|MM36 topical ointment, 1%, applied twice daily for 15 days
11291741|NCT02946021|BG000|Baseline|Pneumatic Compression-1 Session Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291742|NCT02946021|BG001|Baseline|Pneumatic Compression-2 Sessions Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291743|NCT02946021|BG002|Baseline|Total|Total of all reporting groups
11291744|NCT02946021|FG000|Participant Flow|Pneumatic Compression-1 Session Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291745|NCT02946021|FG001|Participant Flow|Pneumatic Compression-2 Sessions Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291746|NCT02946021|OG000|Outcome|Pneumatic Compression-1 Session Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291747|NCT02946021|OG001|Outcome|Pneumatic Compression-2 Sessions Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11336327|NCT03565068|EG015|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
11291748|NCT02946021|EG000|Reported Event|Pneumatic Compression-1 Session Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291749|NCT02946021|EG001|Reported Event|Pneumatic Compression-2 Sessions Per Day|"Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).~Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema~NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects."
11291750|NCT02946034|BG000|Baseline|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin (2 patients)~8 or 12 week therapy with Mavyret (8 patients)"
11291751|NCT02946034|FG000|Participant Flow|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin (2 patients)~8 or 12 week therapy with Mavyret (8 patients)"
11291752|NCT02946034|OG000|Outcome|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin (2 patients)~8 or 12 week therapy with Mavyret (8 patients)"
11291753|NCT02946034|OG000|Outcome|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin~8 or 12 week therapy with Mavyret~Viekira Pak ± ribavirin: 12 weeks treatment with AbbVie Viekira Pak ± ribavirin~Mavyret: 8 or 12 weeks treatment with AbbVie Mavyret"
11291754|NCT02946034|OG000|Outcome|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin (2 patients)~8 or 12 week therapy with Mavryet (8 patients)"
11291755|NCT02946034|EG000|Reported Event|Viekira Pak ± Ribavirin or Mavyret|"12 week therapy with Viekira Pak ± ribavirin (2 patients)~8 or 12 week therapy with Mavyret (8 patients"
11291756|NCT02946073|BG000|Baseline|CAM2038 q1w or q4w BPN Treatment- Double Blind Phase|CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
11291757|NCT02946073|BG001|Baseline|Placebo Subcutaneous Injections-Double Blind Phase|CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
11291758|NCT02946073|BG002|Baseline|De Novo Subjects-Open Label|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291759|NCT02946073|BG003|Baseline|Rollover Subjects-Open Label|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291760|NCT02946073|BG004|Baseline|Total|Total of all reporting groups
11291761|NCT02946073|FG000|Participant Flow|CAM2038 q1w or q4w BPN Treatment- Double Blind Phase|CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
11291762|NCT02946073|FG001|Participant Flow|Placebo Subcutaneous Injections-Double Blind Phase|CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly
11291763|NCT02946073|FG002|Participant Flow|De Novo Subjects-Open Label Phase|"De Novo subjects proceeded directly from the Open-Label Titration Period to the Open-Label Safety Extension Phase without participating in the Double-Blind Treatment Period. CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291764|NCT02946073|FG003|Participant Flow|Rollover Subjects-Open Label|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291765|NCT02946073|OG000|Outcome|CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291766|NCT02946073|OG001|Outcome|Placebo Subcutaneous Injections|CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
11291767|NCT02946073|OG000|Outcome|De Novo|"CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg.~buprenorphine"
11291768|NCT02946073|OG001|Outcome|CAM2038|CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during both Double Blind Phase and Open Label Phase
11291769|NCT02946073|OG002|Outcome|Rollover Placebo Injections|Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
11291770|NCT02946073|OG000|Outcome|CAM2038|"CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg.~buprenorphine"
11291771|NCT02946073|OG001|Outcome|Placebo|CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
11291772|NCT02946073|OG000|Outcome|CAM2038|"CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg.~buprenorphine"
11291773|NCT02946073|OG001|Outcome|Placebo|"CAM2038 placebo injections~Placebo"
11291774|NCT02946073|OG000|Outcome|CAM2038|"CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg.~buprenorphine"
11291775|NCT02946073|EG000|Reported Event|CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase|CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
11291776|NCT02946073|EG001|Reported Event|CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase|CAM2038 50 mg/mL q1w at doses of 4, mg 8 mg, 12 mg, CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
11291777|NCT02946073|EG002|Reported Event|Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase|CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
11291778|NCT02946073|EG003|Reported Event|De Novo Subjects-Open Label, Titration Period Only|CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
11291779|NCT02946073|EG004|Reported Event|Rollover Subjects-Open Label, Titration Period Only|CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection
11291780|NCT02946073|EG005|Reported Event|De Novo Subjects-Open Label, Enrollment Period Only|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291781|NCT02946073|EG006|Reported Event|Rollover Subjects-Open Label, Enrollment Period Only|"CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)~CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)"
11291782|NCT02946229|BG000|Baseline|MHD Population Ultrasound|"Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.~Ultrasound scan: Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types."
11291783|NCT02946229|FG000|Participant Flow|MHD Population Ultrasound|"Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.~Ultrasound scan: Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types."
11291784|NCT02946229|OG000|Outcome|MHD Population Ultrasound|"Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.~Ultrasound scan: Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types."
11291785|NCT02946229|EG000|Reported Event|MHD Population Ultrasound|"Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.~Ultrasound scan: Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types."
11291786|NCT02946385|BG000|Baseline|B_0_2|Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
11291787|NCT02946385|BG001|Baseline|ABCWY_0_2|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291788|NCT02946385|BG002|Baseline|Naive_B|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
11291789|NCT02946385|BG003|Baseline|ABCWY_0_6|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291790|NCT02946385|BG004|Baseline|Naive_ABCWY|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
11291791|NCT02946385|BG005|Baseline|ABCWY_0_2_6|Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291792|NCT02946385|BG006|Baseline|TOTAL|Total of all reporting groups
11291793|NCT02946385|FG000|Participant Flow|B_0_2|Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
11291794|NCT02946385|FG001|Participant Flow|ABCWY_0_2|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291795|NCT02946385|FG002|Participant Flow|Naive_B|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
11291796|NCT02946385|FG003|Participant Flow|ABCWY_0_6|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291797|NCT02946385|FG004|Participant Flow|Naive_ABCWY|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
11291798|NCT02946385|FG005|Participant Flow|ABCWY_0_2_6|Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291799|NCT02946385|OG000|Outcome|ABCWY_0_2|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291800|NCT02946385|OG001|Outcome|ABCWY_0_2_6|Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291801|NCT02946385|OG002|Outcome|ABCWY_0_6|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291802|NCT02946385|OG003|Outcome|B_0_2|Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
11291803|NCT02946385|OG004|Outcome|Naive_ALL|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
11291804|NCT02946385|OG003|Outcome|Naive_ABCWY|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
11291805|NCT02946385|OG000|Outcome|B_0_2|Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
11291806|NCT02946385|OG001|Outcome|Naive_B|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
11291807|NCT02946385|OG004|Outcome|Naive_ABCWY|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
11291808|NCT02946385|OG005|Outcome|Naive_B|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
11291809|NCT02946385|OG000|Outcome|ABCWY_0_2|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study.
11291810|NCT02946385|OG001|Outcome|ABCWY_0_2_6|Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study.
11291811|NCT02946385|EG000|Reported Event|B_0_2|Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
11291812|NCT02946385|EG001|Reported Event|ABCWY_0_2|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291813|NCT02946385|EG002|Reported Event|Naive_B|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
11291814|NCT02946385|EG003|Reported Event|ABCWY_0_6|Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291815|NCT02946385|EG004|Reported Event|Naive_ABCWY|Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
11291816|NCT02946385|EG005|Reported Event|ABCWY_0_2_6|Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
11291817|NCT02946463|BG000|Baseline|Ravulizumab|Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
11216024|NCT02303262|EG000|Reported Event|Mocetinostat and Gemcitabine|"For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.~Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.~Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle."
11216025|NCT02303574|BG000|Baseline|AZD7986 5 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.
11216026|NCT02303574|BG001|Baseline|AZD7986 15 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 15mg on Day 1in fasted state.
11216027|NCT02303574|BG002|Baseline|AZD7986 35 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.
11216028|NCT02303574|BG003|Baseline|AZD7986 50 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 50mg on Day 1 in fasted state.
11216029|NCT02303574|BG004|Baseline|AZD7986 65 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 65mg on Day 1 in fasted state.
11216030|NCT02303574|BG005|Baseline|AZD7986 35 mg (Fed State) - SAD|Participants of Cohorts 3 from Part 1a received single dose of oral solution of AZD7986 35 mg on Day 1 in fed state after a washout of at least 7 days.
11216031|NCT02303574|BG006|Baseline|AZD7986 10 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 10 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216032|NCT02303574|BG007|Baseline|AZD7986 25 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 25 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216033|NCT02303574|BG008|Baseline|AZD7986 40 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 40 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216034|NCT02303574|BG009|Baseline|Placebo - Part 1a (Fasted)|Randomized participants received orally AZD7986 matching placebo oral solution on Day 1 in fasted state.
11216035|NCT02303574|BG010|Baseline|Placebo - Part 1b (Fed State)|Randomized participants received orally AZD7986 matching placebo oral solution on Day 1 in fed state.
11216036|NCT02303574|BG011|Baseline|Placebo - Part 2|Randomized participants received orally AZD7986 matching placebo oral solution for 28 days (fasted/fed state, based on part 1b results).
11216037|NCT02303574|BG012|Baseline|Total|Total of all reporting groups
11216038|NCT02303574|FG000|Participant Flow|AZD7986 5 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.
11216039|NCT02303574|FG001|Participant Flow|AZD7986 15 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 15mg on Day 1in fasted state.
11216040|NCT02303574|FG002|Participant Flow|AZD7986 35 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.
11216041|NCT02303574|FG003|Participant Flow|AZD7986 50 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 50mg on Day 1 in fasted state.
11216042|NCT02303574|FG004|Participant Flow|AZD7986 65 mg (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 65mg on Day 1 in fasted state.
11216043|NCT02303574|FG005|Participant Flow|AZD7986 35 mg (Fed State) - SAD|Participants of Cohorts 3 from Part 1a received single dose of oral solution of AZD7986 35 mg on Day 1 in fed state after a washout of at least 7 days.
11216044|NCT02303574|FG006|Participant Flow|AZD7986 10 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 10 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216045|NCT02303574|FG007|Participant Flow|AZD7986 25 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 25 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216046|NCT02303574|FG008|Participant Flow|AZD7986 40 mg - MAD|Participants received single dose (morning) of oral solution of AZD7986 40 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216047|NCT02303574|FG009|Participant Flow|Placebo|Randomized participants received orally AZD7986 matching placebo oral solution.
11216048|NCT02303574|OG000|Outcome|Part 1a (Fasted State) - Single Ascending Dose (SAD)|Participants received single dose of oral solution of AZD7986 at 5 ascending doses (5mg, 15mg, 35mg, 50mg and 65mg) on Day 1 in fasted state with 6 participants in each dose level.
11216049|NCT02303574|OG001|Outcome|Part 1b (Fed State) - SAD|5 Participants of Cohort 3 from Part 1a received single dose of oral solution of AZD7986 35mg on Day 1 in fed state after a washout of at least 7 days.
11216050|NCT02303574|OG002|Outcome|Part 2 - Multiple Ascending Dose (MAD)|24 participants (6 in Cohort 1-10mg, 8 in Cohort 2- 25mg and 10 in Cohort 3-40mg) received once daily dose of oral solution of AZD7986 in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216051|NCT02303574|OG003|Outcome|Placebo - Part 1a (Fasted State)- SAD|3 participants per dose level received single dose of oral solution of placebo in Part 1a in fasted state on Day 1
11216052|NCT02303574|OG004|Outcome|Placebo - Part 1b (Fed State) - SAD|3 participants of Cohort 3 from Part 1a received single dose of oral solution of placebo 35mg on Day 1 in fed state after a washout of at least 7 days.
11216053|NCT02303574|OG005|Outcome|Placebo - Part 2 - MAD|12 participants (randomized 6:3, 8:3 and 10:4/10:6/12:4) received once daily dose of oral solution of Placebo in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216054|NCT02303574|OG000|Outcome|AZD7986 5mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.
11216055|NCT02303574|OG001|Outcome|AZD7986 15mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 15mg on Day 1.
11216056|NCT02303574|OG002|Outcome|AZD7986 35mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.
11216057|NCT02303574|OG003|Outcome|AZD7986 50mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 50mg on Day 1
11216058|NCT02303574|OG004|Outcome|AZD7986 65mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 65mg on Day 1
11216059|NCT02303574|OG005|Outcome|AZD7986 35mg - Part 1b (Fed State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1.
11216060|NCT02303574|OG000|Outcome|AZD7986 10mg - Day 1 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 10mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216061|NCT02303574|OG001|Outcome|AZD7986 25mg - Day 1 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 25mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216062|NCT02303574|OG002|Outcome|AZD7986 40mg - Day 1 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.
11216063|NCT02303574|OG003|Outcome|AZD7986 10mg - Day 21 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 10mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216064|NCT02303574|OG004|Outcome|AZD7986 25mg - Day 28 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 25mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216065|NCT02303574|OG005|Outcome|AZD7986 40mg - Day 28 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.
11216066|NCT02303574|OG004|Outcome|AZD7986 25mg - Day 28 - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 25mg on Day 1 and daily dosing on Days 21 or 28 in fasted state
11216067|NCT02303574|OG000|Outcome|AZD7986 35mg - Part 1a (Fasted State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.
11216068|NCT02303574|OG001|Outcome|AZD7986 35mg - Part 1b (Fed State) - SAD|Participants received single dose of oral solution of AZD7986 35mg on Day 1.
11216069|NCT02303574|OG000|Outcome|AZD7986 10mg - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 10mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216070|NCT02303574|OG001|Outcome|AZD7986 25mg - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 25mg on Day 1 and daily dosing on Days 21 or 28 in fasted state.
11216071|NCT02303574|OG002|Outcome|AZD7986 40mg - Part 2 - MAD|Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.
11216072|NCT02303574|OG003|Outcome|Placebo - Part 2 - MAD|12 participants (randomized 6:3, 8:3 and 10:4/10:6/12:4) received once daily dose of oral solution of Placebo in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216073|NCT02303574|EG000|Reported Event|Part 1a (Fasted State) - Single Ascending Dose (SAD)|Participants received single dose of oral solution of AZD7986 at 5 ascending doses (5mg, 15mg, 35mg, 50mg and 65mg) on Day 1 in fasted state with 6 participants in each dose level.
11216074|NCT02303574|EG001|Reported Event|Part 1b (Fed State) - SAD|5 Participants of Cohort 3 from Part 1a received single dose of oral solution of AZD7986 35mg on Day 1 in fed state after a washout of at least 7 days.
11216075|NCT02303574|EG002|Reported Event|Part 2 - Multiple Ascending Dose (MAD)|24 participants (6 in Cohort 1-10mg, 8 in Cohort 2- 25mg and 10 in Cohort 3-40mg) received once daily dose of oral solution of AZD7986 in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216076|NCT02303574|EG003|Reported Event|Placebo - Part 1a (Fasted State)- SAD|3 participants per dose level received single dose of oral solution of placebo in Part 1a in fasted state on Day 1
11216077|NCT02303574|EG004|Reported Event|Placebo - Part 1b (Fed State) - SAD|3 participants of Cohort 3 from Part 1a received single dose of oral solution of placebo 35mg on Day 1 in fed state after a washout of at least 7 days.
11216078|NCT02303574|EG005|Reported Event|Placebo - Part 2 - MAD|12 participants (randomized 6:3, 8:3 and 10:4/10:6/12:4) received once daily dose of oral solution of Placebo in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
11216079|NCT02303704|BG000|Baseline|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts
11216080|NCT02303704|BG001|Baseline|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
11216081|NCT02303704|BG002|Baseline|Total|Total of all reporting groups
11216082|NCT02303704|FG000|Participant Flow|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
11216083|NCT02303704|FG001|Participant Flow|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
11216084|NCT02303704|OG000|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
11216085|NCT02303704|OG001|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
11216086|NCT02303704|EG000|Reported Event|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
11216087|NCT02303704|EG001|Reported Event|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
11216088|NCT02303743|BG000|Baseline|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
11216089|NCT02303743|BG001|Baseline|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
11216090|NCT02303743|BG002|Baseline|Total|Total of all reporting groups
11216091|NCT02303743|FG000|Participant Flow|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
11216092|NCT02303743|FG001|Participant Flow|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
11216093|NCT02303743|OG000|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
11216094|NCT02303743|OG001|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
11216095|NCT02303743|EG000|Reported Event|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
11216096|NCT02303743|EG001|Reported Event|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
11216097|NCT02303977|BG000|Baseline|Gemcitabine + Paciltaxel|All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
11216098|NCT02303977|FG000|Participant Flow|Gemcitabine + Paciltaxel|All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
11216099|NCT02303977|OG000|Outcome|Gemcitabine + Paciltaxel|All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
11216100|NCT02303977|OG000|Outcome|Gemcitabine + Paciltaxel|"All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.~Abraxane~Gemcitabine"
11216101|NCT02303977|EG000|Reported Event|Gemcitabine + Paciltaxel|All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
11216102|NCT02303990|BG000|Baseline|Single Arm|"Hypofractionated RT and Pembro~Pembrolizumab~Radiotherapy"
11216103|NCT02303990|FG000|Participant Flow|Single Arm|"Hypofractionated RT and Pembro~Pembrolizumab~Radiotherapy"
11216104|NCT02303990|OG000|Outcome|Single Arm|"Hypofractionated RT and Pembro~Pembrolizumab~Radiotherapy"
11216105|NCT02303990|EG000|Reported Event|Single Arm|"Hypofractionated RT and Pembro~Pembrolizumab~Radiotherapy"
11216106|NCT02304159|BG000|Baseline|Group A - 16 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216107|NCT02304159|BG001|Baseline|Group B - 24 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216108|NCT02304159|BG002|Baseline|Total|Total of all reporting groups
11216109|NCT02304159|FG000|Participant Flow|Group A - 16 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216110|NCT02304159|FG001|Participant Flow|Group B - 24 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216111|NCT02304159|OG000|Outcome|Group A - 16 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216112|NCT02304159|OG001|Outcome|Group B - 24 Weeks|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216113|NCT02304159|EG000|Reported Event|Group A - 16 Weeks of Treatment|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11291818|NCT02946463|BG001|Baseline|Eculizumab|Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
11291819|NCT02946463|BG002|Baseline|Total|Total of all reporting groups
11291820|NCT02946463|FG000|Participant Flow|Ravulizumab|Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 5 years.
11291821|NCT02946463|FG001|Participant Flow|Eculizumab|Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks. After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 5 years.
11291822|NCT02946463|OG000|Outcome|Ravulizumab|Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
11291823|NCT02946463|OG001|Outcome|Eculizumab|Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
11291824|NCT02946463|EG000|Reported Event|Ravulizumab|Participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg on Day 1. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Day 15 and every 8 weeks thereafter for 26 weeks.
11291825|NCT02946463|EG001|Reported Event|Eculizumab|Participants received 600 mg of eculizumab on Days 1, 8, 15, and 22, followed by 900 mg of eculizumab on Day 29 and every 2 weeks thereafter for 26 weeks.
11291826|NCT02946489|BG000|Baseline|CI-581a+MET+MBRP|"Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP~CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4."
11291827|NCT02946489|FG000|Participant Flow|CI-581a+MET+MBRP|"Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP~CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4."
11291828|NCT02946489|OG000|Outcome|CI-581a+MET+MBRP|"Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP~CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4."
11291829|NCT02946489|EG000|Reported Event|CI-581a+MET+MBRP|"Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP~CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4."
11291830|NCT02946515|BG000|Baseline|Educational Intervention|"The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.~The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor."
11291831|NCT02946515|BG001|Baseline|Waitlist Control Group|The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
11291832|NCT02946515|BG002|Baseline|Total|Total of all reporting groups
11291833|NCT02946515|FG000|Participant Flow|Educational Intervention|"The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.~The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor."
11291834|NCT02946515|FG001|Participant Flow|Waitlist Control Group|The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
11291835|NCT02946515|OG000|Outcome|Educational Intervention|"The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.~The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor."
11291836|NCT02946515|OG001|Outcome|Waitlist Control Group|The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
11216114|NCT02304159|EG001|Reported Event|Group A - 24 Weeks of Treatment|"Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks~daclatasvir, Daklinza~Sofosbuvir, Sovaldi~Ribavirin"
11216115|NCT02304380|BG000|Baseline|ACO Stakeholder Interviews|Stakeholders from the ACO, insurance payers, departments of health, and representatives from other stakeholder organizations who have knowledge of/experience with care coordination for children with disabilities before and after the 2013 policy change. Informants included leaders, staff, clinicians, representatives Medicaid managed care organizations, and representatives from public health organizations.
11216116|NCT02304380|BG001|Baseline|Caregiver & Youth Focus Groups|"Caregivers of children with disabilities, and youth (i.e. patients) with disabilities.~To be eligible to participate, the child (as the participant, OR of the caregiver) must:~Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disable (ABD) status since at least one year before the policy change;~Be no more than 18 years of age at the time of data collection; and~Have been, at the time of the policy change, at least 14 years of age for youth (patient) focus groups, or 2 years of age for caregiver focus groups."
11216117|NCT02304380|BG002|Baseline|Caregiver Interviews|Caregivers of children with disabilities. To be eligible to participate, the caregiver's child must: 1. Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disabled (ABD) status since at least one year before the policy change; 2. Be no more than 18 years of age at the time of data collection; and 3. Have been, at the time of the policy change, at least 2 years of age.
11216118|NCT02304380|BG003|Baseline|Caregiver Survey|Caregivers of children with disabilities who are part of the ACO, and fall into one of three categories: 1) children with ABD status with continuous enrollment since July 2013; 2) children with ABD status with 12 month continuous enrollment as of February 2015; and 3) children who were ABD status as of July 2013 who are no longer eligible for ABD but qualify for Medicaid and are still in the ACO.
11216119|NCT02304380|BG004|Baseline|Claims Data-ACO Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status. These are unique participants. They were not consented or considered enrolled."
11216120|NCT02304380|BG005|Baseline|Claims Data-Control Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes children with disabilities on Medicaid under ABD who moved from fee-for-service coverage to non-ACO managed care. Excluded children who enrolled in managed care before the policy change and children not in managed care after the policy change. These are unique participants. They were not consented or considered enrolled."
11216121|NCT02304380|BG006|Baseline|Total|Total of all reporting groups
11216122|NCT02304380|FG000|Participant Flow|Accountable Care Organization (ACO) Stakeholder Interviews|Stakeholders from the ACO, insurance payers, departments of health, and representatives from other stakeholder organizations who have knowledge of/experience with care coordination for children with disabilities before and after the 2013 policy change. Informants included leaders, staff, clinicians, representatives Medicaid managed care organizations, and representatives from public health organizations.
11216123|NCT02304380|FG001|Participant Flow|Caregiver & Youth Focus Groups|"Caregivers of children with disabilities, and youth (i.e. patients) with disabilities.~To be eligible to participate, the child (as the participant, OR of the caregiver) must:~Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disable (ABD) status since at least one year before the policy change;~Be no more than 18 years of age at the time of data collection; and~Have been, at the time of the policy change, at least 14 years of age for youth (patient) focus groups, or 2 years of age for caregiver focus groups."
11216124|NCT02304380|FG002|Participant Flow|Caregiver Interviews|Caregivers of children with disabilities. To be eligible to participate, the caregiver's child must: 1. Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disabled (ABD) status since at least one year before the policy change; 2. Be no more than 18 years of age at the time of data collection; and 3. Have been, at the time of the policy change, at least 2 years of age.
11216125|NCT02304380|FG003|Participant Flow|Caregiver Survey|Caregivers of children with disabilities who are part of the ACO, and fall into one of three categories: 1) children with ABD status with continuous enrollment since July 2013; 2) children with ABD status with 12 month continuous enrollment as of February 2015; and 3) children who were ABD status as of July 2013 who are no longer eligible for ABD but qualify for Medicaid and are still in the ACO.
11216126|NCT02304380|FG004|Participant Flow|Claims Data-ACO Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status. These are unique participants. They were not consented or considered enrolled."
11216127|NCT02304380|FG005|Participant Flow|Claims Data-Control Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes children with disabilities on Medicaid under ABD who moved from fee-for-service coverage to non-ACO managed care. Excluded children who enrolled in managed care before the policy change and children not in managed care after the policy change. These are unique participants. They were not consented or considered enrolled."
11216128|NCT02304380|OG000|Outcome|Caregiver Survey|Caregivers of children with disabilities who are part of the Accountable Care Organization (ACO), and fall into one of three categories: 1) children with Medicaid Aged, Blind, or Disabled (ABD) status with continuous enrollment since July 2013; 2) children with ABD status with 12 month continuous enrollment as of February 2015; and 3) children who were ABD status as of July 2013 who are no longer eligible for ABD but qualify for Medicaid and are still in the ACO.
11216129|NCT02304380|OG000|Outcome|Claims Data-ACO Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status. These are unique participants. They were not consented or considered enrolled."
11291837|NCT02946515|EG000|Reported Event|Educational Intervention|"The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.~The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor."
11291838|NCT02946515|EG001|Reported Event|Waitlist Control Group|The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
11291839|NCT02946580|BG000|Baseline|MOVANTIK™ (Naloxegol)|"Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.~MOVANTIK™ (naloxegol)"
11291840|NCT02946580|BG001|Baseline|Sugar Pill|"Matching placebo consists of an inert mixture supplied by AstraZeneca in identical-appearing tablets. Subjects in the placebo group will be administered a placebo tablet once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing).~Sugar Pill"
11291841|NCT02946580|BG002|Baseline|Total|Total of all reporting groups
11291842|NCT02946580|FG000|Participant Flow|MOVANTIK™ (Naloxegol)|"Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.~MOVANTIK™ (naloxegol)"
11291843|NCT02946580|FG001|Participant Flow|Sugar Pill|"Matching placebo consists of an inert mixture supplied by AstraZeneca in identical-appearing tablets. Subjects in the placebo group will be administered a placebo tablet once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing).~Sugar Pill"
11291844|NCT02946580|OG000|Outcome|MOVANTIK™ (Naloxegol)|"Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.~MOVANTIK™ (naloxegol)"
11291845|NCT02946580|OG001|Outcome|Sugar Pill|"Matching placebo consists of an inert mixture supplied by AstraZeneca in identical-appearing tablets. Subjects in the placebo group will be administered a placebo tablet once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing).~Sugar Pill"
11291846|NCT02946580|EG000|Reported Event|MOVANTIK™ (Naloxegol)|"Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.~MOVANTIK™ (naloxegol)"
11291847|NCT02946580|EG001|Reported Event|Sugar Pill|"Matching placebo consists of an inert mixture supplied by AstraZeneca in identical-appearing tablets. Subjects in the placebo group will be administered a placebo tablet once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing).~Sugar Pill"
11291848|NCT02946892|BG000|Baseline|All Study Participants|Since All Participants Would Be Randomized to Both Interventions, all Patients were Analyzed
11291849|NCT02946892|FG000|Participant Flow|Carvedilol First, Then Placebo|Study participants will receive carvedilol for 12 weeks, washout for 6 weeks, then placebo for 12 weeks
11291850|NCT02946892|FG001|Participant Flow|Placebo First, Then Carvedilol|Study participants will receive placebo (sugar pill) for 12 weeks, then washout for 6 weeks, then carvedilol for 12 weeks
11291851|NCT02946892|OG000|Outcome|Carvedilol|"Study participants will receive carvedilol for 12 weeks~Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed"
11291852|NCT02946892|OG001|Outcome|Placebo|"Study participants will receive placebo (sugar pill) for 12 weeks~Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed"
11291853|NCT02946892|EG000|Reported Event|Carvedilol|"Study participants will receive carvedilol for 12 weeks~Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed"
11291854|NCT02946892|EG001|Reported Event|Placebo|"Study participants will receive placebo (sugar pill) for 12 weeks~Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed"
11291855|NCT02946918|BG000|Baseline|Tablets|"Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291856|NCT02946918|BG001|Baseline|Gelcaps|"Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291857|NCT02946918|BG002|Baseline|Total|Total of all reporting groups
11291858|NCT02946918|FG000|Participant Flow|Tablets|"Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291859|NCT02946918|FG001|Participant Flow|Gelcaps|"Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291860|NCT02946918|OG000|Outcome|Tablets|"Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291861|NCT02946918|OG001|Outcome|Gelcaps|"Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291862|NCT02946918|EG000|Reported Event|Tablets|"Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291863|NCT02946918|EG001|Reported Event|Gelcaps|"Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)~Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps"
11291864|NCT02947984|BG000|Baseline|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
11291865|NCT02947984|BG001|Baseline|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
11291866|NCT02947984|BG002|Baseline|Total|Total of all reporting groups
11291867|NCT02947984|FG000|Participant Flow|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
11291868|NCT02947984|FG001|Participant Flow|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
11291869|NCT02947984|OG000|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
11291870|NCT02947984|OG001|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
11291871|NCT02947984|EG000|Reported Event|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
11291872|NCT02947984|EG001|Reported Event|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
11291873|NCT02947997|BG000|Baseline|OFDI Capsule Imaging|Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system
11291874|NCT02947997|FG000|Participant Flow|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.~OFDI capsule: Imaging of esophagus using OFDI capsule and system"
11291875|NCT02947997|OG000|Outcome|OFDI Capsule Imaging|Subjects who swallowed the OFDI capsule and good quality imaging was acquired using the OFDI imaging system.
11291876|NCT02947997|EG000|Reported Event|OFDI Capsule Imaging|"Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.~OFDI capsule: Imaging of esophagus using OFDI capsule and system"
11291877|NCT02948257|BG000|Baseline|VASCADE VCS|The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
11291878|NCT02948257|FG000|Participant Flow|VASCADE VCS|The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
11291879|NCT02948257|OG000|Outcome|VASCADE VCS|The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
11291880|NCT02948257|EG000|Reported Event|VASCADE VCS|The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
11291881|NCT02948426|BG000|Baseline|Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml)|"Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291882|NCT02948426|BG001|Baseline|Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291883|NCT02948426|BG002|Baseline|Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291884|NCT02948426|BG003|Baseline|Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml)|"Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291885|NCT02948426|BG004|Baseline|Total|Total of all reporting groups
11291886|NCT02948426|FG000|Participant Flow|Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml)|"Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291887|NCT02948426|FG001|Participant Flow|Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291888|NCT02948426|FG002|Participant Flow|Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291889|NCT02948426|FG003|Participant Flow|Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml)|"Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291890|NCT02948426|OG000|Outcome|All Participants On Dose Level 1 Through Dose Level 4|Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Dose Level 2 - Sylatron 25µg (0.1µg/ml); Dose Level 3 - Sylatron 25mcg; Dose Level 4 - Sylatron 250mcg
11291891|NCT02948426|OG000|Outcome|All Participants On Dose Level 1 Through Dose Level 4|Dose Level 1 - Actimmune 5mcg (0.02µg/ml); Dose Level 2 - Actimmune 5mcg (0.02µg/ml); Dose Level 3 - Actimmune 5mcg; Dose Level 4 - Actimmune 50mcg
11291892|NCT02948426|OG000|Outcome|Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml)|"Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291893|NCT02948426|OG001|Outcome|Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291894|NCT02948426|OG002|Outcome|Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291895|NCT02948426|OG003|Outcome|Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml)|"Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291896|NCT02948426|EG000|Reported Event|Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml)|"Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291897|NCT02948426|EG001|Reported Event|Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291898|NCT02948426|EG002|Reported Event|Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml)|"Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11332549|NCT03497130|FG000|Participant Flow|Regimen Group|After 1 week washout period using provided Dove® Soap without any moisturizer, participants in the skin care regimen group will receive Vaseline® Moisturizer, Dove® Soap, and application log. These participants will be asked to apply the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.
11291899|NCT02948426|EG003|Reported Event|Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml)|"Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml). The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal.~Autologous Monocytes + ACTIMMUNE + SYLATRON: The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD)."
11291900|NCT02948582|BG000|Baseline|Total Participants|Intent to treat population same as safety population -not full analysis set
11291901|NCT02948582|FG000|Participant Flow|Treatment Group 1|subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg
11291902|NCT02948582|FG001|Participant Flow|Treatment Group 2|subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo
11291903|NCT02948582|FG002|Participant Flow|Treatment Group 3|subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg
11291904|NCT02948582|FG003|Participant Flow|Treatment Group 4|subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg
11291905|NCT02948582|FG004|Participant Flow|Treatment Group 5|subjects received glycopyrrolate 200 mcg, glycopyrrolate 12.5 mcg, placebo, glycopryrrolate 400mcg, placebo, glycopyrrolate 100mcg, or glycoyrrolate 50mcg
11291906|NCT02948582|FG005|Participant Flow|Treatment Group 6|subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg
11291907|NCT02948582|OG000|Outcome|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
10970957|NCT00913068|BG001|Baseline|Standard Post Operative Pain Control|Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
11291908|NCT02948582|OG001|Outcome|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
11291909|NCT02948582|OG002|Outcome|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
11291910|NCT02948582|OG003|Outcome|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
11291911|NCT02948582|OG004|Outcome|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
11291912|NCT02948582|OG005|Outcome|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
11291913|NCT02948582|EG000|Reported Event|Glycopyrrolate Inhalation Solution12.5μg|"Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily"
11291914|NCT02948582|EG001|Reported Event|Glycopyrrolate Inhalation Solution 50μg|"Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily"
11291915|NCT02948582|EG002|Reported Event|Glycopyrrolate Inhalation Solution 100μg|"Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily"
11291916|NCT02948582|EG003|Reported Event|Glycopyrrolate Inhalation Solution 200μg|"Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily"
11291917|NCT02948582|EG004|Reported Event|Glycopyrrolate Inhalation Solution 400μg|"Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily~Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily"
11291918|NCT02948582|EG005|Reported Event|Placebo 0.5mL|"Placebo 0.5mL via e-flow nebulizer, once daily~Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily"
11291919|NCT02948634|BG000|Baseline|Sham Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy.~Sham Phoenix Laser Treatment: Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring."
10970958|NCT00913068|BG002|Baseline|Total|Total of all reporting groups
11291920|NCT02948634|BG001|Baseline|Active Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.~Active Phoenix Laser Treatment: The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin."
11291921|NCT02948634|BG002|Baseline|Total|Total of all reporting groups
11291922|NCT02948634|FG000|Participant Flow|Sham Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy.~Sham Phoenix Laser Treatment: Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring."
11291923|NCT02948634|FG001|Participant Flow|Active Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.~Active Phoenix Laser Treatment: The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin."
11291924|NCT02948634|OG000|Outcome|Sham Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy.~Sham Phoenix Laser Treatment: Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring."
11291925|NCT02948634|OG001|Outcome|Active Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.~Active Phoenix Laser Treatment: The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin."
11291926|NCT02948634|EG000|Reported Event|Sham Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy.~Sham Phoenix Laser Treatment: Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring."
11291927|NCT02948634|EG001|Reported Event|Active Phoenix Laser Treatment|"Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.~Active Phoenix Laser Treatment: The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin."
11291928|NCT02948777|BG000|Baseline|Evolocumab|Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks
11291929|NCT02948777|FG000|Participant Flow|Evolocumab|Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks
10970959|NCT00913068|FG000|Participant Flow|TAP Arm|in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm
10970960|NCT00913068|FG001|Participant Flow|Standard Post Operative Pain Control|Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
10970961|NCT00913068|OG000|Outcome|TAP Arm|in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm
10970962|NCT00913068|OG001|Outcome|Standard Post Operative Pain Control|Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
10970963|NCT00913068|EG000|Reported Event|TAP Arm|in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm
10970964|NCT00913068|EG001|Reported Event|Standard Post Operative Pain Control|Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
10970965|NCT00913081|BG000|Baseline|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
10970966|NCT00913081|FG000|Participant Flow|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
10970967|NCT00913081|OG000|Outcome|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970968|NCT00913081|OG001|Outcome|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970969|NCT00913081|OG002|Outcome|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970970|NCT00913081|OG003|Outcome|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
11291930|NCT02948777|OG000|Outcome|Evolocumab|Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks
11291931|NCT02948777|OG000|Outcome|Evolocumab|"Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks~Evolocumab"
11291932|NCT02948777|EG000|Reported Event|Evolocumab|"Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks~Evolocumab: Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks"
11291933|NCT02948829|BG000|Baseline|Tetravalent Dengue Vaccine (TDV) 0.5 mL|TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3).
11291934|NCT02948829|FG000|Participant Flow|Tetravalent Dengue Vaccine (TDV) 0.5 mL|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).
11291935|NCT02948829|OG000|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL|TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3).
11291936|NCT02948829|OG000|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).
11291937|NCT02948829|OG000|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama|TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Panama.
11291938|NCT02948829|OG001|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Philippines.
11291939|NCT02948829|OG000|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seropositive status at Baseline.
11291940|NCT02948829|OG001|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seronegative status at Baseline.
11291941|NCT02948829|OG000|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD4+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with CD4+ T cells at the time of analysis.
11291942|NCT02948829|OG001|Outcome|Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD8+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with CD8+ T cells at the time of analysis.
11291943|NCT02948829|OG000|Outcome|TDV 0.5 mL: Panama: CD4+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Panama with CD4+ T cells at the time of analysis.
11291944|NCT02948829|OG001|Outcome|TDV 0.5 mL: Philippines: CD4+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Panama with CD4+ T cells at the time of analysis.
10970971|NCT00913081|EG000|Reported Event|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
11291945|NCT02948829|OG002|Outcome|TDV 0.5 mL: Panama: CD8+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Panama with CD8+ T cells at the time of analysis.
11291946|NCT02948829|OG003|Outcome|TDV 0.5 ml: Philippines: CD8+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants in Panama with CD8+ T cells at the time of analysis.
11291947|NCT02948829|OG000|Outcome|TDV 0.5 mL: Seropositive: CD4+ T-Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seropositive status at Baseline having CD4+ at the time of analysis.
11291948|NCT02948829|OG001|Outcome|TDV 0.5 mL: Seronegative: CD4+ T-Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seronegative status at Baseline having CD4+ at the time of analysis.
11291949|NCT02948829|OG002|Outcome|TDV 0.5 mL: Seropositive: CD8+ T Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seropositive status at Baseline having CD4+ at the time of analysis.
11291950|NCT02948829|OG003|Outcome|TDV 0.5 mL: Seronegative: CD8+ T-Cells|TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3) was received by participants with seronegative status at Baseline having CD4+ at the time of analysis.
11291951|NCT02948829|EG000|Reported Event|Tetravalent Dengue Vaccine (TDV) 0.5 mL|TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3).
11291952|NCT02949011|BG000|Baseline|Baloxavir Marboxil|Participants received either 40 mg or 80 mg of baloxavir marboxil orally on Day 1 based on body weight of < 80 kg or ≥ 80 kg at Screening, respectively. Participants also received placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.
11291953|NCT02949011|BG001|Baseline|Placebo|Participants received placebo to baloxavir marboxil on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5.
11291954|NCT02949011|BG002|Baseline|Oseltamivir|Participants received 75 mg oseltamivir twice a day on Days 1 to 5 and placebo to baloxavir marboxil on Day 1.
11291955|NCT02949011|BG003|Baseline|Total|Total of all reporting groups
11291956|NCT02949011|FG000|Participant Flow|Baloxavir Marboxil|Participants received either 40 mg or 80 mg of baloxavir marboxil orally on Day 1 based on body weight of < 80 kg or ≥ 80 kg at Screening, respectively. Participants also received placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.
11291957|NCT02949011|FG001|Participant Flow|Placebo|Participants received placebo to baloxavir marboxil on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5.
11291958|NCT02949011|FG002|Participant Flow|Oseltamivir|Participants received 75 mg oseltamivir twice a day on Days 1 to 5 and placebo to baloxavir marboxil on Day 1.
11291959|NCT02949011|OG000|Outcome|Baloxavir Marboxil|Participants received either 40 mg or 80 mg of baloxavir marboxil orally on Day 1 based on body weight of < 80 kg or ≥ 80 kg at Screening, respectively. Participants also received placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.
11291960|NCT02949011|OG001|Outcome|Placebo|Participants received placebo to baloxavir marboxil on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5.
11291961|NCT02949011|OG002|Outcome|Oseltamivir|Participants received 75 mg oseltamivir twice a day on Days 1 to 5 and placebo to baloxavir marboxil on Day 1.
11291962|NCT02949011|EG000|Reported Event|Baloxavir Marboxil|Participants received either 40 mg or 80 mg of baloxavir marboxil orally on Day 1 based on body weight of < 80 kg or ≥ 80 kg at Screening, respectively. Participants also received placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.
11291963|NCT02949011|EG001|Reported Event|Placebo|Participants received placebo to baloxavir marboxil on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5.
11291964|NCT02949011|EG002|Reported Event|Oseltamivir|Participants received 75 mg oseltamivir twice a day on Days 1 to 5 and placebo to baloxavir marboxil on Day 1.
11291965|NCT02949024|BG000|Baseline|TX Naïve Arm|"Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.~IVT Aflibercept: IVT aflibercept [2 mg (50 µL)]~SC CLS-TA: [4 mg (100 µL)]"
11291966|NCT02949024|BG001|Baseline|Previous TX Arm|"Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.~SC CLS-TA: [4 mg (100 µL)]"
11291967|NCT02949024|BG002|Baseline|Total|Total of all reporting groups
11291968|NCT02949024|FG000|Participant Flow|TX Naïve Arm|"Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.~IVT Aflibercept: IVT aflibercept [2 mg (50 µL)]~SC CLS-TA: [4 mg (100 µL)]"
11291969|NCT02949024|FG001|Participant Flow|Previous TX Arm|"Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.~SC CLS-TA: [4 mg (100 µL)]"
11291970|NCT02949024|OG000|Outcome|TX Naïve Arm|"Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.~IVT Aflibercept: IVT aflibercept [2 mg (50 µL)]~SC CLS-TA: [4 mg (100 µL)]"
11291971|NCT02949024|OG001|Outcome|Previous TX Arm|"Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.~SC CLS-TA: [4 mg (100 µL)]"
11291972|NCT02949024|OG000|Outcome|Previous TX Arm|"Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.~SC CLS-TA: [4 mg (100 µL)]"
11291973|NCT02949024|OG001|Outcome|TX Naïve Arm|"Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.~IVT Aflibercept: IVT aflibercept [2 mg (50 µL)]~SC CLS-TA: [4 mg (100 µL)]"
11291974|NCT02949024|EG000|Reported Event|TX Naïve Arm|"Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.~IVT Aflibercept: IVT aflibercept [2 mg (50 µL)]~SC CLS-TA: [4 mg (100 µL)]"
11291975|NCT02949024|EG001|Reported Event|Previous TX Arm|"Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.~SC CLS-TA: [4 mg (100 µL)]"
11291976|NCT02949141|BG000|Baseline|Ultrasound|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)~Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography.~No adverse events were recorded."
11291977|NCT02949141|FG000|Participant Flow|All Participants|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)~Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography."
11291978|NCT02949141|OG000|Outcome|Ultrasound|Ultrasound Diagnosis of pneumonia compared to CT (Gold Standard)
11291979|NCT02949141|OG001|Outcome|Chest X-Ray|Chest x-ray diagnosis of pneumonia compared to CT
11291980|NCT02949141|EG000|Reported Event|Ultrasound|"Lung Ultrasound evaluation for pneumonia.~All patients will receive lung ultrasound, chest x-ray and computed tomography.~No adverse events were recorded."
11291981|NCT02949141|EG001|Reported Event|Chest X-ray|Chest x-ray for evaluation of pneumonia.
11291982|NCT02949141|EG002|Reported Event|Chest Ct|Following US and CXR, all patients received a Chest CT as the gold standard for diagnosis of pneumonia.
11291983|NCT02949271|BG000|Baseline|Programmed Intermittent Epidural Bolus|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Programmed Intermittent Epidural Bolus~Ropivacaine~Fentanyl"
11291984|NCT02949271|BG001|Baseline|Continuous Epidural Infusion|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Continuous Epidural Infusion~Ropivacaine~Fentanyl"
11291985|NCT02949271|BG002|Baseline|Total|Total of all reporting groups
11291986|NCT02949271|FG000|Participant Flow|Programmed Intermittent Epidural Bolus|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Programmed Intermittent Epidural Bolus~Ropivacaine~Fentanyl"
11291987|NCT02949271|FG001|Participant Flow|Continuous Epidural Infusion|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Continuous Epidural Infusion~Ropivacaine~Fentanyl"
11291988|NCT02949271|OG000|Outcome|Programmed Intermittent Epidural Bolus|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Programmed Intermittent Epidural Bolus~Ropivacaine~Fentanyl"
11332550|NCT03497130|FG001|Participant Flow|Control Group|"After 1 week washout period using provided Dove® Soap without any moisturizer, Individuals in the control group will continue with the provided Dove® Soap for 2 weeks.~All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use."
11291989|NCT02949271|OG001|Outcome|Continuous Epidural Infusion|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Continuous Epidural Infusion~Ropivacaine~Fentanyl"
11291990|NCT02949271|EG000|Reported Event|Programmed Intermittent Epidural Bolus|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Programmed Intermittent Epidural Bolus~Ropivacaine~Fentanyl"
11291991|NCT02949271|EG001|Reported Event|Continuous Epidural Infusion|"Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.~Continuous Epidural Infusion~Ropivacaine~Fentanyl"
11291992|NCT02949362|BG000|Baseline|Retrospective TED/NTT Group|Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.
11291993|NCT02949362|BG001|Baseline|Retrospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
11291994|NCT02949362|BG002|Baseline|Total|Total of all reporting groups
11291995|NCT02949362|FG000|Participant Flow|Retrospective TED/NTT Group|Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.
11291996|NCT02949362|FG001|Participant Flow|Retrospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
11291997|NCT02949362|FG002|Participant Flow|Prospective TED/NTT Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11291998|NCT02949362|FG003|Participant Flow|Prospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11291999|NCT02949362|OG000|Outcome|Retrospective TED/NTT Group|Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.
11292000|NCT02949362|OG001|Outcome|Retrospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
11292001|NCT02949362|OG000|Outcome|Prospective TED/NTT Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11292002|NCT02949362|OG001|Outcome|Prospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11292003|NCT02949362|OG000|Outcome|Prospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks
11292004|NCT02949362|OG000|Outcome|Prospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11292005|NCT02949362|EG000|Reported Event|Retrospective TED/NTT Group|Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.
11292006|NCT02949362|EG001|Reported Event|Retrospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
10822212|NCT00075270|EG000|Reported Event|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
11292007|NCT02949362|EG002|Reported Event|Prospective TED/NTT Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11292008|NCT02949362|EG003|Reported Event|Prospective TED/TED Group|Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
11292009|NCT02949518|BG000|Baseline|Enhanced Recovery Pathway|An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
11292010|NCT02949518|BG001|Baseline|Usual Care|Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
11292011|NCT02949518|BG002|Baseline|Total|Total of all reporting groups
11292012|NCT02949518|FG000|Participant Flow|Enhanced Recovery Pathway|An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
11292013|NCT02949518|FG001|Participant Flow|Usual Care|Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
11292014|NCT02949518|OG000|Outcome|Enhanced Recovery Pathway (ERP) for Spine|he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
11292015|NCT02949518|OG001|Outcome|Usual Care|anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
11292016|NCT02949518|OG000|Outcome|Enhanced Recovery Pathway|An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
11292017|NCT02949518|OG001|Outcome|Usual Care|Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
11292018|NCT02949518|EG000|Reported Event|Enhanced Recovery Pathway|An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
11292019|NCT02949518|EG001|Reported Event|Usual Care|Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
11292020|NCT02949674|BG000|Baseline|Bupivacaine|"It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.~Bupivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292021|NCT02949674|BG001|Baseline|Ropivacaine|"It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.~Ropivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292022|NCT02949674|BG002|Baseline|Control|No application of anesthetic
11292023|NCT02949674|BG003|Baseline|Total|Total of all reporting groups
11292024|NCT02949674|FG000|Participant Flow|Bupivacaine|"It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.~Bupivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292025|NCT02949674|FG001|Participant Flow|Ropivacaine|"It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.~Ropivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292026|NCT02949674|FG002|Participant Flow|Control|No application of anesthetic
11292027|NCT02949674|OG000|Outcome|Bupivacaine|"It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.~Bupivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292028|NCT02949674|OG001|Outcome|Ropivacaine|"It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.~Ropivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292029|NCT02949674|OG002|Outcome|Control|No application of anesthetic
11292030|NCT02949674|EG000|Reported Event|Bupivacaine|"It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.~Bupivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292031|NCT02949674|EG001|Reported Event|Ropivacaine|"It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.~Ropivacaine: It will be used as a analgesic dose in surgical site before surgery."
11292032|NCT02949674|EG002|Reported Event|Control|No application of anesthetic
11292033|NCT02949908|BG000|Baseline|Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)|Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
11292034|NCT02949908|FG000|Participant Flow|Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)|Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
11292035|NCT02949908|OG000|Outcome|Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)|Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
11292036|NCT02949908|EG000|Reported Event|Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)|Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
11292037|NCT02949921|BG000|Baseline|Group A: MHGS Grade 4 Hands Group|Participants with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292038|NCT02949921|BG001|Baseline|Group B: MHGS Grade 2 or 3 Hands Group|Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292039|NCT02949921|BG002|Baseline|Total|Total of all reporting groups
11292040|NCT02949921|FG000|Participant Flow|Group A: MHGS Grade 4 Hands Group|Participants with Merz hand grading scale (MHGS) Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2 percent (%) lidocaine hydrochloric acid (HCL) up to 3 cubic centimeter (cc) (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292041|NCT02949921|FG001|Participant Flow|Group B: MHGS Grade 2 or 3 Hands Group|Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292042|NCT02949921|OG000|Outcome|Group A: MHGS Grade 4 Hands Group|Participants with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292043|NCT02949921|OG001|Outcome|Group B: MHGS Grade 2 or 3 Hands Group|Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292044|NCT02949921|EG000|Reported Event|Group A: MHGS Grade 4 Hands Group|Participants with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292045|NCT02949921|EG001|Reported Event|Group B: MHGS Grade 2 or 3 Hands Group|Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18.
11292046|NCT02949973|BG000|Baseline|Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care|Voclosporin 23.7 mg Twice Daily (BID)
11292047|NCT02949973|FG000|Participant Flow|Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care|Voclosporin 23.7 mg twice daily (BID)
11292048|NCT02949973|OG000|Outcome|Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care|Voclosporin 23.7 mg Twice Daily (BID)
11292049|NCT02949973|EG000|Reported Event|Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care|Voclosporin 23.7 mg Twice Daily (BID)
11292050|NCT02950025|BG000|Baseline|Arm A: Online Non-adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292051|NCT02950025|BG001|Baseline|Arm B: Online-Adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292052|NCT02950025|BG002|Baseline|Total|Total of all reporting groups
11292053|NCT02950025|FG000|Participant Flow|Arm A: Online Non-adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292054|NCT02950025|FG001|Participant Flow|Arm B: Online-Adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
10970972|NCT00913081|EG001|Reported Event|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970973|NCT00913081|EG002|Reported Event|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970974|NCT00913081|EG003|Reported Event|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
10970975|NCT00913133|BG000|Baseline|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
10970976|NCT00913133|FG000|Participant Flow|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
10970977|NCT00913133|OG000|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
10970978|NCT00913133|EG000|Reported Event|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
10970979|NCT00913263|BG000|Baseline|Group 1|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
10970980|NCT00913263|FG000|Participant Flow|Hydroxyflutamide (2-HOF)|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
10970981|NCT00913263|OG000|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
10970982|NCT00913263|OG000|Outcome|Group 1|24 patients (Part I of the study) have been injected with Liproca Depot once.
10970983|NCT00913263|OG000|Outcome|Part I|Patients (24 patients) in Part I have been injected with Liproca Depot once.
10970984|NCT00913263|OG000|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
10970985|NCT00913263|OG000|Outcome|Part 1|Patients (24 patients) have been injected with Liproca depot once
10970986|NCT00913263|EG000|Reported Event|Group 1|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
10970987|NCT00913380|BG000|Baseline|Low-dose CT|Aimed to 2 mSv in an average patient
10970988|NCT00913380|BG001|Baseline|Standard-dose CT|Aimed to 8 mSv in an average patient
10970989|NCT00913380|BG002|Baseline|Total|Total of all reporting groups
10970990|NCT00913380|FG000|Participant Flow|Low-dose CT|Aimed to 2 mSv in an average patient
10970991|NCT00913380|FG001|Participant Flow|Standard-dose CT|Aimed to 8 mSv in an average patient
10970992|NCT00913380|OG000|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
10970993|NCT00913380|OG001|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
10970994|NCT00913380|EG000|Reported Event|Low-dose CT|Aimed to 2 mSv in an average patient
11292055|NCT02950025|OG000|Outcome|Arm A: Online Non-adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
10970995|NCT00913380|EG001|Reported Event|Standard-dose CT|Aimed to 8 mSv in an average patient
11292056|NCT02950025|OG001|Outcome|Arm B: Online-Adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292057|NCT02950025|EG000|Reported Event|Arm A: Online Non-adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292058|NCT02950025|EG001|Reported Event|Arm B: Online-Adaptive MRI-guided SBRT|"All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)~Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments~All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site~When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day~Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion"
11292059|NCT02950467|BG000|Baseline|Group Therapy Plus Psilocybin|"Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.~Psilocybin: One individual oral psilocybin treatment session~Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy"
11292060|NCT02950467|FG000|Participant Flow|Group Therapy Plus Psilocybin|"Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.~Psilocybin: One individual oral psilocybin treatment session~Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy"
11292061|NCT02950467|OG000|Outcome|Group Therapy Plus Psilocybin|"Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.~Psilocybin: One individual oral psilocybin treatment session~Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy"
11292062|NCT02950467|EG000|Reported Event|Group Therapy Plus Psilocybin|"Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.~Psilocybin: One individual oral psilocybin treatment session~Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy"
11292063|NCT02950545|BG000|Baseline|Crossover Order 1|Placebo, Spherical, Then Toric Lenses
11292064|NCT02950545|BG001|Baseline|Crossover Order 2|Placebo, Toric, Then Spherical Lenses
11292065|NCT02950545|BG002|Baseline|Crossover Order 3|Spherical, Placebo, Then Toric Lenses
11292066|NCT02950545|BG003|Baseline|Crossover Order 4|Spherical, Toric, Then Placebo Lenses
11292067|NCT02950545|BG004|Baseline|Crossover Order 5|Toric, Placebo, Then Spherical Lenses
11292068|NCT02950545|BG005|Baseline|Crossover Order 6|Toric, Spherical, Then Placebo Lenses
11292069|NCT02950545|BG006|Baseline|Total|Total of all reporting groups
11292070|NCT02950545|FG000|Participant Flow|Crossover Order 1|Placebo, Spherical, then Toric lenses
11292071|NCT02950545|FG001|Participant Flow|Crossover Order 2|Placebo, Toric, then Spherical lenses
11292072|NCT02950545|FG002|Participant Flow|Crossover Order 3|Spherical, Placebo, then Toric lenses
11292073|NCT02950545|FG003|Participant Flow|Crossover Order 4|Spherical, Toric, then Placebo lenses
11292074|NCT02950545|FG004|Participant Flow|Crossover Order 5|Toric, Placebo, then Spherical lenses
11292075|NCT02950545|FG005|Participant Flow|Crossover Order 6|Toric, Spherical, then Placebo lenses
11292076|NCT02950545|OG000|Outcome|All Study Participants|Each participant completed (1) Simulated driving with Placebo Lenses (AcuVue Oasys Bandage Lenses with no prescription), (2) Simulated driving with Spherical Lenses (1-DAY ACUVUE® MOIST contact lenses), (3) Simulated driving with Toric Lenses (1-DAY ACUVUE® MOIST for ASTIGMATISM contact...
11292077|NCT02950545|EG000|Reported Event|Placebo|Participants wore the placebo contact lenses during testing
11292078|NCT02950545|EG001|Reported Event|Spherical|Participants wore the spherical contact lenses during testing
11292079|NCT02950545|EG002|Reported Event|Toric|Participants wore the toric contact lenses during testing
11292080|NCT02950558|BG000|Baseline|Standard Care|"Single injection of ropivacaine immediately prior to surgery~Ropivacaine: Single injection of ropivacaine immediately prior to surgery."
11292081|NCT02950558|BG001|Baseline|Ropivacaine Pump|"Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.~Ropivacaine: Single injection of ropivacaine immediately prior to surgery.~Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump."
11292082|NCT02950558|BG002|Baseline|Total|Total of all reporting groups
11292083|NCT02950558|FG000|Participant Flow|Standard Care|"Single injection of ropivacaine immediately prior to surgery~Ropivacaine: Single injection of ropivacaine immediately prior to surgery."
11292084|NCT02950558|FG001|Participant Flow|Ropivacaine Pump|"Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.~Ropivacaine: Single injection of ropivacaine immediately prior to surgery.~Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump."
11292085|NCT02950558|OG000|Outcome|Standard Care|"Single injection of ropivacaine immediately prior to surgery~Ropivacaine: Single injection of ropivacaine immediately prior to surgery."
11292086|NCT02950558|OG001|Outcome|Ropivacaine Pump|"Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.~Ropivacaine: Single injection of ropivacaine immediately prior to surgery.~Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump."
11292087|NCT02950558|OG001|Outcome|Ropivacaine Ppump|"Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.~Ropivacaine: Single injection of ropivacaine immediately prior to surgery.~Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump."
11292088|NCT02950558|EG000|Reported Event|Standard Care|"Single injection of ropivacaine immediately prior to surgery~Ropivacaine: Single injection of ropivacaine immediately prior to surgery."
11292089|NCT02950558|EG001|Reported Event|Ropivacaine Pump|"Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.~Ropivacaine: Single injection of ropivacaine immediately prior to surgery.~Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump."
11292090|NCT02950753|BG000|Baseline|Lactated Ringer|"Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.~Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg)."
11292091|NCT02950753|BG001|Baseline|Normal Saline|"Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.~Normal Saline: Fluid bolus or Normal Saline (30ml/kg)."
11292092|NCT02950753|BG002|Baseline|Total|Total of all reporting groups
11292093|NCT02950753|FG000|Participant Flow|Lactated Ringer|"Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.~Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg)."
11292094|NCT02950753|FG001|Participant Flow|Normal Saline|"Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.~Normal Saline: Fluid bolus or Normal Saline (30ml/kg)."
11292095|NCT02950753|OG000|Outcome|Lactated Ringer|"Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.~Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg)."
10970996|NCT00913458|BG000|Baseline|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
11292096|NCT02950753|OG001|Outcome|Normal Saline|"Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.~Normal Saline: Fluid bolus or Normal Saline (30ml/kg)."
11292097|NCT02950753|EG000|Reported Event|Lactated Ringer|"Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.~Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg)."
11292098|NCT02950753|EG001|Reported Event|Normal Saline|"Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.~Normal Saline: Fluid bolus or Normal Saline (30ml/kg)."
11292099|NCT02950831|BG000|Baseline|Activity and Sleep Quality Recording|"Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment~Accelerometry: Record of activity levels using a wrist worn accelerometer"
11292100|NCT02950831|FG000|Participant Flow|Activity and Sleep Quality Recording|"Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment~Accelerometry: Record of activity levels using a wrist worn accelerometer"
11292101|NCT02950831|OG000|Outcome|Activity and Sleep Quality Recording|"Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment~Accelerometry: Record of activity levels using a wrist worn accelerometer"
11292102|NCT02950831|EG000|Reported Event|Activity and Sleep Quality Recording|"Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment~Accelerometry: Record of activity levels using a wrist worn accelerometer"
11292103|NCT02951143|BG000|Baseline|Single Arm|"All participants will complete the same experimental events across 6 laboratory sessions.~SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task."
11292104|NCT02951143|BG001|Baseline|0.4 mg/g Concentration|"Participants in this arm will experience the 0.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292105|NCT02951143|BG002|Baseline|1.3 mg/g Concentration|"Participants in this arm will experience the 1.3 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292106|NCT02951143|BG003|Baseline|2.4 mg/g Concentration|"Participants in this arm will experience the 2.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292107|NCT02951143|BG004|Baseline|5.2 mg/g Concentration|"Participants in this arm will experience the 5.2 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292108|NCT02951143|BG005|Baseline|15.8 mg/g Concentration|"Participants in this arm will experience the 15.8 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292109|NCT02951143|BG006|Baseline|Total|Total of all reporting groups
11292110|NCT02951143|FG000|Participant Flow|Single Arm|"All participants will complete the same experimental events across 6 laboratory sessions.~SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task."
11292111|NCT02951143|FG001|Participant Flow|0.4 mg/g Concentration|"Participants in this arm will experience the 0.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292112|NCT02951143|FG002|Participant Flow|1.3 mg/g Concentration|"Participants in this arm will experience the 1.3 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292113|NCT02951143|FG003|Participant Flow|2.4 mg/g Concentration|"Participants in this arm will experience the 2.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292114|NCT02951143|FG004|Participant Flow|5.2 mg/g Concentration|"Participants in this arm will experience the 5.2 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
10970997|NCT00913458|FG000|Participant Flow|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
11292115|NCT02951143|FG005|Participant Flow|15.8 mg/g Concentration|"Participants in this arm will experience the 15.8 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292116|NCT02951143|OG000|Outcome|Single Arm|"All participants will complete the same experimental events across 6 laboratory sessions.~SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task."
11292117|NCT02951143|OG001|Outcome|0.4 mg/g Concentration|"Participants in this arm will experience the 0.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292118|NCT02951143|OG002|Outcome|1.3 mg/g Concentration|"Participants in this arm will experience the 1.3 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292119|NCT02951143|OG003|Outcome|2.4 mg/g Concentration|"Participants in this arm will experience the 2.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11336328|NCT03565068|EG016|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336329|NCT03565068|EG017|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
11292120|NCT02951143|OG004|Outcome|5.2 mg/g Concentration|"Participants in this arm will experience the 5.2 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292121|NCT02951143|OG005|Outcome|15.8 mg/g Concentration|"Participants in this arm will experience the 15.8 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292122|NCT02951143|EG000|Reported Event|Single Arm|"All participants will complete the same experimental events across 6 laboratory sessions.~SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task."
11292123|NCT02951143|EG001|Reported Event|0.4 mg/g Concentration|"Participants in this arm will experience the 0.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292124|NCT02951143|EG002|Reported Event|1.3 mg/g Concentration|"Participants in this arm will experience the 1.3 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292125|NCT02951143|EG003|Reported Event|2.4 mg/g Concentration|"Participants in this arm will experience the 2.4 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292126|NCT02951143|EG004|Reported Event|5.2 mg/g Concentration|"Participants in this arm will experience the 5.2 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292127|NCT02951143|EG005|Reported Event|15.8 mg/g Concentration|"Participants in this arm will experience the 15.8 mg/g Concentration~SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times."
11292128|NCT02951156|BG000|Baseline|Avelumab+Rituximab+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292129|NCT02951156|BG001|Baseline|Avelumab+Azacitidine+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292130|NCT02951156|BG002|Baseline|Avelumab+Bendamustine+Rituximab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days.
10970998|NCT00913458|FG001|Participant Flow|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
11292131|NCT02951156|BG003|Baseline|Total|Total of all reporting groups
11292132|NCT02951156|FG000|Participant Flow|Avelumab+Rituximab+Utomilumab|Avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 milligram per meter square (mg/m^2) IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292133|NCT02951156|FG001|Participant Flow|Avelumab+Azacitidine+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 subcutaneous (SC) dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292134|NCT02951156|FG002|Participant Flow|Avelumab+Bendamustine+Rituximab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days.
11292135|NCT02951156|OG000|Outcome|Avelumab+Rituximab+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292136|NCT02951156|OG001|Outcome|Avelumab+Azacitidine+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292137|NCT02951156|OG002|Outcome|Avelumab+Bendamustine+Rituximab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days.
11292138|NCT02951156|OG001|Outcome|Avelumab+Bendamustine+Rituximab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days.
11292139|NCT02951156|EG000|Reported Event|Avelumab+Rituximab+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292140|NCT02951156|EG001|Reported Event|Avelumab+Azacitidine+Utomilumab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days.
11292141|NCT02951156|EG002|Reported Event|Avelumab+Bendamustine+Rituximab|Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days.
11292142|NCT02951182|BG000|Baseline|Part 1: Placebo - Cohort 1A and 1B Combined|Participants received placebo matched to VX-440/TEZ/IVA as triple combination for 4 weeks.
11292143|NCT02951182|BG001|Baseline|Part 1 Cohort 1A: Triple Combination (TC)|Participants received VX-440 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h as triple combination for 4 weeks.
11292144|NCT02951182|BG002|Baseline|Part 1 Cohort 1B: TC Low Dose|Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks.
11292145|NCT02951182|BG003|Baseline|Part 1 Cohort 1B: TC High Dose|Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks.
11292146|NCT02951182|BG004|Baseline|Part 2: TEZ/IVA|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292147|NCT02951182|BG005|Baseline|Part 2: TC-2|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292148|NCT02951182|BG006|Baseline|Total|Total of all reporting groups
11292149|NCT02951182|FG000|Participant Flow|Part 1: Placebo - Cohort 1A and 1B Combined|Participants received placebo matched to VX-440/tezacaftor (TEZ; VX-661)/ivacaftor (IVA, VX-770) as triple combination for 4 weeks.
11292150|NCT02951182|FG001|Participant Flow|Part 1 Cohort 1A: Triple Combination (TC)|Participants received VX-440 200 milligram (mg) every 12 hours (q12h)/TEZ 100 mg once daily (qd)/IVA 150 mg q12h as triple combination for 4 weeks.
11292151|NCT02951182|FG002|Participant Flow|Part 1 Cohort 1B: TC Low Dose|Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks.
11292152|NCT02951182|FG003|Participant Flow|Part 1 Cohort 1B: TC High Dose|Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks.
11292153|NCT02951182|FG004|Participant Flow|Part 2: TEZ/IVA|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292154|NCT02951182|FG005|Participant Flow|Part 2: TC-2|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292155|NCT02951182|OG000|Outcome|Part 1: Placebo - Cohort 1A and 1B Combined|Participants received placebo matched to VX-440/TEZ/IVA as triple combination for 4 weeks.
11292156|NCT02951182|OG001|Outcome|Part 1 Cohort 1A: Triple Combination (TC)|Participants received VX-440 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h as triple combination for 4 weeks.
11292157|NCT02951182|OG002|Outcome|Part 1 Cohort 1B: TC Low Dose|Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks.
11292158|NCT02951182|OG003|Outcome|Part 1 Cohort 1B: TC High Dose|Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks.
11292159|NCT02951182|OG004|Outcome|Part 2: TEZ/IVA|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292160|NCT02951182|OG005|Outcome|Part 2: TC-2|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292161|NCT02951182|OG001|Outcome|Part 1: TC-1A/ TC-1B-low Pooled|All participants pooled together for Part 1: TC-1A arm and Part 1: TC-1B low dose arm.
11292162|NCT02951182|OG002|Outcome|Part 1 Cohort 1B: TC High Dose|Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks.
11292163|NCT02951182|OG003|Outcome|Part 2: TEZ/IVA|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292164|NCT02951182|OG004|Outcome|Part 2: TC-2|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292165|NCT02951182|OG000|Outcome|Part 1 Cohort 1A: Triple Combination (TC)|Participants received VX-440 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h as triple combination for 4 weeks.
11292166|NCT02951182|OG001|Outcome|Part 1 Cohort 1B: TC Low Dose|Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks.
11292167|NCT02951182|EG000|Reported Event|Part 1: Placebo - Cohort 1A and 1B Combined|Participants received placebo matched to VX-440/TEZ/IVA as triple combination for 4 weeks.
11292168|NCT02951182|EG001|Reported Event|Part 1 Cohort 1A: Triple Combination (TC)|Participants received VX-440 200 mg q12/TEZ 100 mg qd/IVA 150 mg q12h as triple combination for 4 weeks.
11292169|NCT02951182|EG002|Reported Event|Part 1 Cohort 1B: TC Low Dose|Participants received VX-440 200 mg q12h/TEZ 50 mg q12h/IVA 150 mg q12h as triple combination for 4 weeks.
11292170|NCT02951182|EG003|Reported Event|Part 1 Cohort 1B: TC High Dose|Participants received VX-440 600 mg q12h/TEZ 50 mg q12h/IVA 300 mg q12h as triple combination for 4 weeks.
11292171|NCT02951182|EG004|Reported Event|Part 2: TEZ/IVA|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received placebo matched to VX-440 and TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292172|NCT02951182|EG005|Reported Event|Part 2: TC-2|Following a 4-week run-in period on TEZ 100 mg qd/IVA150 mg q12h, participants received VX-440 600 mg q12h/ TEZ 50 mg q12h/IVA 300 mg q12h for 4 weeks for 4 weeks in treatment period and TEZ 100 mg qd/IVA150 mg q12h for 4 weeks in washout period.
11292173|NCT02951195|BG000|Baseline|Part 1: Placebo|Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
11292174|NCT02951195|BG001|Baseline|Part 1 Cohort 1A: TC|Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292175|NCT02951195|BG002|Baseline|Part 1 Cohort 1B: TC|Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292176|NCT02951195|BG003|Baseline|Part 1 Cohort 1C: TC|Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292177|NCT02951195|BG004|Baseline|Part 2 Cohort 2A: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292178|NCT02951195|BG005|Baseline|Part 2 Cohort 2A: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292179|NCT02951195|BG006|Baseline|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292180|NCT02951195|BG007|Baseline|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292181|NCT02951195|BG008|Baseline|Total|Total of all reporting groups
11292182|NCT02951195|FG000|Participant Flow|Part 1: Placebo|Participants received placebo matched to VX-152/TEZ/IVA triple combination (TC) for 2 weeks.
11292183|NCT02951195|FG001|Participant Flow|Part 1 Cohort 1A: TC|Participants received VX-152 100 milligram (mg) every 12 hours (q12h)/TEZ 100 mg once daily (qd)/IVA 150 mg q12h TC for 2 weeks.
11292184|NCT02951195|FG002|Participant Flow|Part 1 Cohort 1B: TC|Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292185|NCT02951195|FG003|Participant Flow|Part 1 Cohort 1C: TC|Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292186|NCT02951195|FG004|Participant Flow|Part 2 Cohort 2A: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292187|NCT02951195|FG005|Participant Flow|Part 2 Cohort 2A: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292188|NCT02951195|FG006|Participant Flow|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292189|NCT02951195|FG007|Participant Flow|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292190|NCT02951195|OG000|Outcome|Part 1: Placebo|Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
11292191|NCT02951195|OG001|Outcome|Part 1 Cohort 1A: TC|Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292192|NCT02951195|OG002|Outcome|Part 1 Cohort 1B: TC|Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292193|NCT02951195|OG003|Outcome|Part 1 Cohort 1C: TC|Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292194|NCT02951195|OG004|Outcome|Part 2 Cohort 2A: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292195|NCT02951195|OG005|Outcome|Part 2 Cohort 2A: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292196|NCT02951195|OG006|Outcome|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292197|NCT02951195|OG007|Outcome|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292198|NCT02951195|OG000|Outcome|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292199|NCT02951195|OG001|Outcome|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292200|NCT02951195|OG000|Outcome|Part 1: Placebo|Participants received placebo matched to VX-152/TEZ/IVA for 2 weeks.
11292201|NCT02951195|OG000|Outcome|Part 1 Cohort 1A: TC|Participants received VX-152 100 mg q12h/TEZ 100 qd/IVA 150 mg q12h TC for 2 weeks.
11292202|NCT02951195|OG001|Outcome|Part 1 Cohort 1B: TC|Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292203|NCT02951195|OG002|Outcome|Part 1 Cohort 1C: TC|Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292204|NCT02951195|OG003|Outcome|Part 2 Cohort 2A: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292205|NCT02951195|OG004|Outcome|Part 2 Cohort 2A: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292206|NCT02951195|OG005|Outcome|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292207|NCT02951195|OG006|Outcome|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292208|NCT02951195|EG000|Reported Event|Part 1: Placebo|Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
11292209|NCT02951195|EG001|Reported Event|Part 1 Cohort 1A: TC|Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292210|NCT02951195|EG002|Reported Event|Part 1 Cohort 1B: TC|Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292211|NCT02951195|EG003|Reported Event|Part 1 Cohort 1C: TC|Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
11292212|NCT02951195|EG004|Reported Event|Part 2 Cohort 2A: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292213|NCT02951195|EG005|Reported Event|Part 2 Cohort 2A: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292214|NCT02951195|EG006|Reported Event|Part 2 Cohort 2B: TEZ/IVA|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292215|NCT02951195|EG007|Reported Event|Part 2 Cohort 2B: TC|Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
11292216|NCT02951273|BG000|Baseline|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
11292217|NCT02951273|FG000|Participant Flow|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
11292218|NCT02951273|OG000|Outcome|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
11292219|NCT02951273|EG000|Reported Event|Study of Cerebral Blood Flow|"Patients undergoing oesophageal- or ventricular resection (n=30)~Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
11292220|NCT02951312|BG000|Baseline|25mg Glycopyrrolate, 200mg Gloycopyrrolate|subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
11292221|NCT02951312|BG001|Baseline|75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate|subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
11292222|NCT02951312|BG002|Baseline|200mg Glycopyrrolate Jet|subjects received 200mg Glycopyrrolate
11292223|NCT02951312|BG003|Baseline|Placebo|subjects received placebo
11292224|NCT02951312|BG004|Baseline|Total|Total of all reporting groups
11292225|NCT02951312|FG000|Participant Flow|25mg Glycopyrrolate, 200mg Gloycopyrrolate|subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo
11292226|NCT02951312|FG001|Participant Flow|75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate|subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo
11292227|NCT02951312|FG002|Participant Flow|200mg Glycopyrrolate Jet|subjects received 200mg Glycopyrrolate
11292228|NCT02951312|FG003|Participant Flow|Placebo|Subjects received placebo
11292229|NCT02951312|OG000|Outcome|Glycopyrrolate Inhalation Solution 25mg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
11292230|NCT02951312|OG001|Outcome|Glycopyrrolate Inhalation Solution 75mg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily"
11216130|NCT02304380|OG001|Outcome|Claims Data-Control Sample|"Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes children with disabilities on Medicaid under ABD who moved from fee-for-service coverage to non-ACO managed care. Excluded children who enrolled in managed care before the policy change and children not in managed care after the policy change. These are unique participants. They were not consented or considered enrolled."
11216131|NCT02304380|OG000|Outcome|Claims Data-ACO Sample|Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status
11216132|NCT02304380|OG001|Outcome|Claims Data-Control Sample|Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes children with disabilities on Medicaid under ABD who moved from fee-for-service coverage to non-ACO managed care. Excluded children who enrolled in managed care before the policy change and children not in managed care after the policy change.
11216133|NCT02304380|OG000|Outcome|Claims Data-ACO Sample|Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status.
11216134|NCT02304380|EG000|Reported Event|Accountable Care Organization (ACO) Stakeholder Interviews|Stakeholders from the ACO, insurance payers, departments of health, and representatives from other stakeholder organizations who have knowledge of/experience with care coordination for children with disabilities before and after the 2013 policy change. Informants included leaders, staff, clinicians, representatives Medicaid managed care organizations, and representatives from public health organizations.
11216135|NCT02304380|EG001|Reported Event|Caregiver & Youth Focus Groups|"Caregivers of children with disabilities, and youth (i.e. patients) with disabilities.~To be eligible to participate, the child (as the participant, OR of the caregiver) must:~Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disable (ABD) status since at least one year before the policy change;~Be no more than 18 years of age at the time of data collection; and~Have been, at the time of the policy change, at least 14 years of age for youth (patient) focus groups, or 2 years of age for caregiver focus groups."
11216136|NCT02304380|EG002|Reported Event|Caregiver Interviews|Caregivers of children with disabilities. To be eligible to participate, the caregiver's child must: 1. Have resided continuously in the region served by the ACO, have been continuously enrolled in Medicaid, and have had Medicaid Aged, Blind, or Disabled (ABD) status since at least one year before the policy change; 2. Be no more than 18 years of age at the time of data collection; and 3. Have been, at the time of the policy change, at least 2 years of age.
11216137|NCT02304380|EG003|Reported Event|Caregiver Survey|Caregivers of children with disabilities who are part of the ACO, and fall into one of three categories: 1) children with ABD status with continuous enrollment since July 2013; 2) children with ABD status with 12 month continuous enrollment as of February 2015; and 3) children who were ABD status as of July 2013 who are no longer eligible for ABD but qualify for Medicaid and are still in the ACO.
11216138|NCT02304380|EG004|Reported Event|Claims Data-ACO Sample|Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes any child who was ABD status at any point during August 2011-June 2016; dataset does not include children without ABD status.
11216139|NCT02304380|EG005|Reported Event|Claims Data-Control Sample|Claims and enrollment data from the Ohio Medicaid program from August 2011-July 2016 (23 months before entering ACO, 30 months post); dataset includes children with disabilities on Medicaid under ABD who moved from fee-for-service coverage to non-ACO managed care. Excluded children who enrolled in managed care before the policy change and children not in managed care after the policy change.
11216140|NCT02304406|BG000|Baseline|Non-Small Cell Lung Cancer|Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
11216141|NCT02304406|FG000|Participant Flow|Non-Small Cell Lung Cancer|Tissue samples of participants of Middle East North Africa (MENA) previously diagnosed with non-small cell lung cancer (NSCLC) were tested retrospectively for the prevalence of anaplastic lymphoma kinase (ALK) rearrangement.
11216142|NCT02304406|OG000|Outcome|Non-Small Cell Lung Cancer|Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
11216143|NCT02304406|EG000|Reported Event|Non-Small Cell Lung Cancer|Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.
11216144|NCT02304432|BG000|Baseline|All Study Participants|"Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~Add crossover phase and second OL phase"
11216145|NCT02304432|FG000|Participant Flow|Open Label DCS|"Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
11216146|NCT02304432|FG001|Participant Flow|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
11216147|NCT02304432|FG002|Participant Flow|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
11216148|NCT02304432|FG003|Participant Flow|Second Open Label DCS|"Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.~D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
11216149|NCT02304432|OG000|Outcome|First Open Label DCS|Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
11216150|NCT02304432|OG001|Outcome|Second Open Label DCS|Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
11216151|NCT02304432|OG000|Outcome|Placebo First, Then DCS|"One of the sequences during the DB period; dose of DCS, freq of admin; length of trial~Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.~D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.~DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks."
11216152|NCT02304432|OG001|Outcome|DCS First, Then Placebo|One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
11216153|NCT02304432|OG000|Outcome|First Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
11216154|NCT02304432|OG001|Outcome|Second Open Label DCS|Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
11216155|NCT02304432|OG000|Outcome|Open Label DCS|During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. One subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
11216156|NCT02304432|OG000|Outcome|Open Label DCS|During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. OOne subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
11216157|NCT02304432|OG000|Outcome|First Open Label DCS|The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
11216158|NCT02304432|EG000|Reported Event|Open Label DCS|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
11216159|NCT02304432|EG001|Reported Event|DCS (Crossover)|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 6 weeks.
11216160|NCT02304432|EG002|Reported Event|PLACEBO (CROSSOVER)|Both participants received placebo for 6 weeks.
11216161|NCT02304432|EG003|Reported Event|Second Open Label DCS|"Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.~D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks."
11216162|NCT02304484|BG000|Baseline|Evolocumab|Participants received 420 mg evolocumab once a month for up to 2 years.
11216163|NCT02304484|FG000|Participant Flow|Evolocumab|Participants received 420 mg evolocumab once a month for up to 2 years.
11216164|NCT02304484|OG000|Outcome|Evolocumab|Participants received 420 mg evolocumab once a month for up to 2 years.
11216165|NCT02304484|EG000|Reported Event|Evolocumab|Participants received 420 mg evolocumab once a month for up to 2 years.
11216166|NCT02304705|BG000|Baseline|Placebo|"Placebo three times per day, orally~Placebo: One capsule TID PO for 90 days"
11216167|NCT02304705|BG001|Baseline|Sildenafil|"Sildenafil 20 mg three times per day, orally~Sildenafil: 20 mg TID PO for 90 days"
11216168|NCT02304705|BG002|Baseline|Total|Total of all reporting groups
11216169|NCT02304705|FG000|Participant Flow|Placebo|"Placebo three times per day, orally~Placebo: One capsule three times daily by mouth for 90 days"
11216170|NCT02304705|FG001|Participant Flow|Sildenafil|Sildenafil 20 mg three times per day, orally for 90 days
11216171|NCT02304705|OG000|Outcome|Placebo|"Placebo three times per day, orally~Placebo: One capsule TID PO for 90 days"
11216172|NCT02304705|OG001|Outcome|Sildenafil|"Sildenafil 20 mg three times per day, orally~Sildenafil: 20 mg TID PO for 90 days"
11216173|NCT02304705|EG000|Reported Event|Placebo|"Placebo three times per day, orally~Placebo: One capsule TID PO for 90 days"
11216174|NCT02304705|EG001|Reported Event|Sildenafil|"Sildenafil 20 mg three times per day, orally~Sildenafil: 20 mg TID PO for 90 days"
11216175|NCT02304757|BG000|Baseline|99Tc-MDP|"15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.~99Tc-MDP: 99Tc-MDP, H20000218"
11216176|NCT02304757|BG001|Baseline|Fosamax|"70mg po every week for 12 months.~Alendronate Sodium: H20080172"
11216177|NCT02304757|BG002|Baseline|Total|Total of all reporting groups
11216178|NCT02304757|FG000|Participant Flow|99Tc-MDP|"15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.~99Tc-MDP: 99Tc-MDP, H20000218"
11216179|NCT02304757|FG001|Participant Flow|Fosamax|"70mg po every week for 12 months.~Alendronate Sodium: H20080172"
11216180|NCT02304757|OG000|Outcome|99Tc-MDP|"15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.~99Tc-MDP: 99Tc-MDP, H20000218"
11216181|NCT02304757|OG001|Outcome|Fosamax|"70mg po every week for 12 months.~Alendronate Sodium: H20080172"
11216182|NCT02304757|EG000|Reported Event|99Tc-MDP|"15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.~99Tc-MDP: 99Tc-MDP, H20000218"
11216183|NCT02304757|EG001|Reported Event|Fosamax|"70mg po every week for 12 months.~Alendronate Sodium: H20080172"
11292231|NCT02951312|OG002|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
11292232|NCT02951312|OG003|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
11292233|NCT02951312|OG004|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
11292234|NCT02951312|OG005|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
11292235|NCT02951312|OG006|Outcome|Placebo 0.5 mL|"Placebo 0.5 mL via jet nebulizer, once daily~Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily"
11292236|NCT02951312|OG000|Outcome|Glycopyrrolate Inhalation Solution 200mg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily"
11216184|NCT02304926|BG000|Baseline|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216185|NCT02304926|BG001|Baseline|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216186|NCT02304926|BG002|Baseline|Total|Total of all reporting groups
11216187|NCT02304926|FG000|Participant Flow|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216188|NCT02304926|FG001|Participant Flow|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216189|NCT02304926|OG000|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216190|NCT02304926|OG001|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216191|NCT02304926|OG000|Outcome|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216192|NCT02304926|OG001|Outcome|Ezetimibe|"19 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11216193|NCT02304926|EG000|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected
11216194|NCT02304926|EG001|Reported Event||Adverse events were not collected
11216195|NCT02305017|BG000|Baseline|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11216196|NCT02305017|BG001|Baseline|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11216197|NCT02305017|BG002|Baseline|Total|Total of all reporting groups
11216198|NCT02305017|FG000|Participant Flow|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11216199|NCT02305017|FG001|Participant Flow|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11216200|NCT02305017|OG000|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
11216201|NCT02305017|OG001|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
11216202|NCT02305017|OG000|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079
11216203|NCT02305017|OG001|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
11216204|NCT02305017|OG000|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
11216205|NCT02305017|OG001|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
11216206|NCT02305017|EG000|Reported Event|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
11216207|NCT02305017|EG001|Reported Event|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
11292237|NCT02951312|OG001|Outcome|Glycopyrrolate Inhalation Solution 200mg Jet|"Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily~Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily"
11292238|NCT02951312|OG002|Outcome|Glycopyrrolate Inhalation Solution 500mg|"Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily"
11292239|NCT02951312|OG003|Outcome|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily"
11292240|NCT02951312|EG000|Reported Event|Glycopyrrolate Inhalation Solution 25 μg|"Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily"
11292241|NCT02951312|EG001|Reported Event|Glycopyrrolate Inhalation Solution75μg|"Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily"
11292242|NCT02951312|EG002|Reported Event|Glycopyrrolate Inhalation Solution 200 μg|"Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily"
11292243|NCT02951312|EG003|Reported Event|Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer,|"Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily~Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily"
11292244|NCT02951312|EG004|Reported Event|Glycopyrrolate Inhalation Solution 500μg|"Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily~Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily"
11292245|NCT02951312|EG005|Reported Event|Glycopyrrolate Inhalation Solution1000mg|"Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily~Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily"
11292246|NCT02951312|EG006|Reported Event|Placebo|"Placebo~Placebo"
11292247|NCT02951351|BG000|Baseline|Standard Procedure + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292248|NCT02951351|BG001|Baseline|Proparacaine + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.~Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292249|NCT02951351|BG002|Baseline|Total|Total of all reporting groups
11292250|NCT02951351|FG000|Participant Flow|Standard Procedure + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292251|NCT02951351|FG001|Participant Flow|Proparacaine + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.~Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292252|NCT02951351|OG000|Outcome|Standard Procedure + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292253|NCT02951351|OG001|Outcome|Proparacaine + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.~Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292254|NCT02951351|EG000|Reported Event|Standard Procedure + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292255|NCT02951351|EG001|Reported Event|Proparacaine + Culture|"Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.~Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.~Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis."
11292256|NCT02951429|BG000|Baseline|Pirfenidone+Sildenafil|Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks.
11292257|NCT02951429|BG001|Baseline|Pirfenidone+Placebo|Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks.
11292258|NCT02951429|BG002|Baseline|Total|Total of all reporting groups
11292259|NCT02951429|FG000|Participant Flow|Pirfenidone+Sildenafil|Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks.
11292260|NCT02951429|FG001|Participant Flow|Pirfenidone+Placebo|Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks.
11292261|NCT02951429|OG000|Outcome|Pirfenidone+Sildenafil|Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks.
11292262|NCT02951429|OG001|Outcome|Pirfenidone+Placebo|Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks.
11292263|NCT02951429|EG000|Reported Event|Pirfenidone+Sildenafil|Participants received pirfenidone along with sildenafil, orally, three times a day for 52 weeks.
11292264|NCT02951429|EG001|Reported Event|Pirfenidone+Placebo|Participants received pirfenidone along with placebo matched to sildenafil, orally, three times a day for 52 weeks.
11292265|NCT02951533|BG000|Baseline|Guselkumab (GUS)|Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.
11292266|NCT02951533|BG001|Baseline|Fumaric Acid Esters (FAE)|Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292267|NCT02951533|BG002|Baseline|Total|Total of all reporting groups
11292268|NCT02951533|FG000|Participant Flow|Guselkumab (GUS)|Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.
11292269|NCT02951533|FG001|Participant Flow|Fumaric Acid Esters (FAE)|Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292270|NCT02951533|FG002|Participant Flow|FAE to Guselkumab|At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Weeks 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who received GUS in Study Part II (participants who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
11292271|NCT02951533|OG000|Outcome|Part I: Guselkumab (GUS)|Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
11292272|NCT02951533|OG001|Outcome|Part I: Fumaric Acid Esters (FAE)|Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
11292273|NCT02951533|OG000|Outcome|Part IIb: Guselkumab (GUS)|At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292274|NCT02951533|OG001|Outcome|Part IIb: Fumaric Acid Esters (FAE)|At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292275|NCT02951533|OG000|Outcome|Part I/IIa: Guselkumab (GUS)|In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292276|NCT02951533|OG001|Outcome|Part I/IIa: FAE|In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292277|NCT02951533|OG000|Outcome|Part III: Guselkumab (GUS)|Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
11292278|NCT02951533|OG001|Outcome|Part III: FAE to Guselkumab|At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
11292279|NCT02951533|EG000|Reported Event|Part I/IIa (Week 0 to Week 32): Guselkumab (GUS)|In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292280|NCT02951533|EG001|Reported Event|Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE)|In Part I, Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
11292281|NCT02951533|EG002|Reported Event|Part IIb (Week 32 Through Week 56): Guselkumab (GUS)|At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
11292282|NCT02951533|EG003|Reported Event|Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE)|At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
11292283|NCT02951533|EG004|Reported Event|Part IIb (Week 32 Through Week 56): FAE to Guselkumab|At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
11292284|NCT02951533|EG005|Reported Event|Part III (Week 64 Through Week 100): Guselkumab|Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
11292285|NCT02951533|EG006|Reported Event|Part III (Week 64 Through Week 100): FAE to Guselkumab|At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
11292286|NCT02951702|BG000|Baseline|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
11292287|NCT02951702|BG001|Baseline|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
11292288|NCT02951702|BG002|Baseline|Total|Total of all reporting groups
11292289|NCT02951702|FG000|Participant Flow|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
11292290|NCT02951702|FG001|Participant Flow|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
11292291|NCT02951702|OG000|Outcome|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
11292292|NCT02951702|OG001|Outcome|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
11292293|NCT02951702|EG000|Reported Event|Control|"This will be the historical arm that has not received oral vancomycin but match criteria for high risk"
11292294|NCT02951702|EG001|Reported Event|Vancomycin|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician~Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
11292295|NCT02951780|BG000|Baseline|Cohort A (Sequence 1,9,7: 6,4,8:5,3,2)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292296|NCT02951780|BG001|Baseline|Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292297|NCT02951780|BG002|Baseline|Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292298|NCT02951780|BG003|Baseline|Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292299|NCT02951780|BG004|Baseline|Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292300|NCT02951780|BG005|Baseline|Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292301|NCT02951780|BG006|Baseline|Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11336330|NCT03565068|EG018|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11292302|NCT02951780|BG007|Baseline|Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292303|NCT02951780|BG008|Baseline|Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292304|NCT02951780|BG009|Baseline|Total|Total of all reporting groups
11292305|NCT02951780|FG000|Participant Flow|Cohort A (Sequence 1-9-7: 6-4-8: 5-3-2)|"LY3185643 and rGlucagon were administered as single subcutaneous (SC) doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 microgram (μg) LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292306|NCT02951780|FG001|Participant Flow|Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292307|NCT02951780|FG002|Participant Flow|Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292308|NCT02951780|FG003|Participant Flow|Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292309|NCT02951780|FG004|Participant Flow|Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292310|NCT02951780|FG005|Participant Flow|Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292311|NCT02951780|FG006|Participant Flow|Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292312|NCT02951780|FG007|Participant Flow|Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292313|NCT02951780|FG008|Participant Flow|Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )|"LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3.~Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon."
11292314|NCT02951780|OG000|Outcome|10 ug LY3185643|LY3185643 has been administered SC as single dose of 10 ug.
11292315|NCT02951780|OG001|Outcome|25 ug LY3185643|LY3185643 has been administered SC as single dose of 25 ug.
11292316|NCT02951780|OG002|Outcome|50 ug LY3185643|LY3185643 has been administered SC as single dose of 50 ug.
11292317|NCT02951780|OG003|Outcome|100 ug LY3185643|LY3185643 has been administered SC as single dose of 100 ug.
11292318|NCT02951780|OG004|Outcome|200 ug LY3185643|LY3185643 has been administered SC as single dose of 200 ug.
11292319|NCT02951780|OG005|Outcome|10 ug rGlucagon|rGlucagon has been administered SC as single dose of 10 ug.
11292320|NCT02951780|OG006|Outcome|25 ug rGlucagon|rGlucagon has been administered SC as single dose of 25 ug.
11292321|NCT02951780|OG007|Outcome|50 ug rGlucagon|rGlucagon has been administered SC as single dose of 50 ug.
11292322|NCT02951780|OG008|Outcome|200 ug rGlucagon|rGlucagon has been administered SC as single dose of 200 ug.
11292323|NCT02951780|EG000|Reported Event|10 ug LY3185643|LY3185643 has been administered SC as single dose of 10 ug.
11292324|NCT02951780|EG001|Reported Event|25 ug LY3185643|LY3185643 has been administered SC as single dose of 25 ug.
11292325|NCT02951780|EG002|Reported Event|50 ug LY3185643|LY3185643 has been administered SC as single dose of 50 ug.
11292326|NCT02951780|EG003|Reported Event|100 ug LY3185643|LY3185643 has been administered SC as single dose of 100 ug.
11292327|NCT02951780|EG004|Reported Event|200 ug LY3185643|LY3185643 has been administered SC as single dose of 200 ug.
11292328|NCT02951780|EG005|Reported Event|10 ug rGlucagon|rGlucagon has been administered SC as single dose of 10 ug.
11292329|NCT02951780|EG006|Reported Event|25 ug rGlucagon|rGlucagon has been administered SC as single dose of 25 ug.
11292330|NCT02951780|EG007|Reported Event|50 ug rGlucagon|rGlucagon has been administered SC as single dose of 50 ug.
11292331|NCT02951780|EG008|Reported Event|200 ug rGlucagon|rGlucagon has been administered SC as single dose of 200 ug.
11292332|NCT02951819|BG000|Baseline|Newly Diagnosed Multiple Myeloma (NDMM)|Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292333|NCT02951819|BG001|Baseline|Relapsed Multiple Myeloma (RMM)|Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292334|NCT02951819|BG002|Baseline|Total|Total of all reporting groups
11292335|NCT02951819|FG000|Participant Flow|Newly Diagnosed Multiple Myeloma (NDMM)|Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292336|NCT02951819|FG001|Participant Flow|Relapsed Multiple Myeloma (RMM)|Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292337|NCT02951819|OG000|Outcome|Newly Diagnosed Multiple Myeloma (NDMM)|Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292338|NCT02951819|OG001|Outcome|Relapsed Multiple Myeloma (RMM)|Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292339|NCT02951819|EG000|Reported Event|Newly Diagnosed Multiple Myeloma (NDMM)|Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292340|NCT02951819|EG001|Reported Event|Relapsed Multiple Myeloma (RMM)|Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
11292341|NCT02951884|BG000|Baseline|Aspiration|Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee.
11292342|NCT02951884|BG001|Baseline|Aspiration With Injection|Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine
11292343|NCT02951884|BG002|Baseline|Control|Participants assigned to this arm receive no injection or aspiration therapy.
11292344|NCT02951884|BG003|Baseline|Total|Total of all reporting groups
11292345|NCT02951884|FG000|Participant Flow|Aspiration|Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee.
11292346|NCT02951884|FG001|Participant Flow|Aspiration With Injection|Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine
11292347|NCT02951884|FG002|Participant Flow|Control|Participants assigned to this arm receive no injection or aspiration therapy.
11292348|NCT02951884|OG000|Outcome|Aspiration|Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee.
11292349|NCT02951884|OG001|Outcome|Aspiration With Injection|Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine
11292350|NCT02951884|OG002|Outcome|Control|Participants assigned to this arm receive no injection or aspiration therapy.
11292351|NCT02951884|EG000|Reported Event|Aspiration|Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee.
11292352|NCT02951884|EG001|Reported Event|Aspiration With Injection|Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine
11292353|NCT02951884|EG002|Reported Event|Control|Participants assigned to this arm receive no injection or aspiration therapy.
11292354|NCT02951988|BG000|Baseline|Placebo|Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
11292355|NCT02951988|BG001|Baseline|Rapastinel 450 mg Every 2 Weeks|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
11292356|NCT02951988|BG002|Baseline|Rapastinel 450 mg Weekly|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
11292357|NCT02951988|BG003|Baseline|Total|Total of all reporting groups
11292358|NCT02951988|FG000|Participant Flow|OLTP Rapastinel 450 mg Weekly + ADT|Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP.
11292359|NCT02951988|FG001|Participant Flow|DBTP Placebo|Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
11292360|NCT02951988|FG002|Participant Flow|DBTP Rapastinel 450 mg Every 2 Weeks|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks.
11292361|NCT02951988|FG003|Participant Flow|DBTP Rapastinel 450 mg Weekly|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
11292362|NCT02951988|OG000|Outcome|Placebo|Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
11292363|NCT02951988|OG001|Outcome|Rapastinel 450 mg Every 2 Weeks|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
11292364|NCT02951988|OG002|Outcome|Rapastinel 450 mg Weekly|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
11292365|NCT02951988|OG001|Outcome|Rapastinel 450 mg Every 2 Weeks|Rapastinel 450 mg IV label once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
11292366|NCT02951988|EG000|Reported Event|OLTP Rapastinel 450 mg Weekly + ADT|Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP.
11292367|NCT02951988|EG001|Reported Event|DBTP Placebo|Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
11292368|NCT02951988|EG002|Reported Event|DBTP Rapastinel 450 mg Every 2 Weeks|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks.
11292369|NCT02951988|EG003|Reported Event|DBTP Rapastinel 450 mg Weekly|Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
11292370|NCT02952001|BG000|Baseline|4 mg CLS-TA Suprachoriodal Injection|"Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292371|NCT02952001|BG001|Baseline|Sham Procedure|"Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292372|NCT02952001|BG002|Baseline|Total|Total of all reporting groups
11292373|NCT02952001|FG000|Participant Flow|4 mg CLS-TA Suprachoriodal Injection|"Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292374|NCT02952001|FG001|Participant Flow|Sham Procedure|"Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292375|NCT02952001|OG000|Outcome|4 mg CLS-TA Suprachoriodal Injection|"Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation i the Parent study without receiving additional therapy. No study drug was administered during this study.~4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292376|NCT02952001|OG001|Outcome|Sham Procedure|"Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292377|NCT02952001|OG000|Outcome|4 mg CLS-TA Suprachoriodal Injection|"Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292378|NCT02952001|EG000|Reported Event|4 mg CLS-TA Suprachoriodal Injection|"Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292379|NCT02952001|EG001|Reported Event|Sham Procedure|"Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.~Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study."
11292380|NCT02952261|BG000|Baseline|CT-guided Localization|"This group of participants received conventional CT-guided lung nodule localization.~CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization."
11292381|NCT02952261|BG001|Baseline|Template-guided Localization|"Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.~template-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."
11292382|NCT02952261|BG002|Baseline|Total|Total of all reporting groups
11292383|NCT02952261|FG000|Participant Flow|CT-guided Localization|"This group of participants received conventional CT-guided lung nodule localization.~CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization."
11292384|NCT02952261|FG001|Participant Flow|Template-guided Localization|"Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.~template-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."
11292385|NCT02952261|OG000|Outcome|CT-guided Localization|"This group of participants received conventional CT-guided lung nodule localization.~CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization."
11292386|NCT02952261|OG001|Outcome|Template-guided Localization|"Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.~template-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."
11336331|NCT03565068|EG019|Reported Event|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
11336332|NCT03565068|EG020|Reported Event|Panel C (Schizophrenia Participants): Placebo Add-on Therapy|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
11216208|NCT02305238|BG000|Baseline|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216209|NCT02305238|BG001|Baseline|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216210|NCT02305238|BG002|Baseline|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
11216211|NCT02305238|BG003|Baseline|Total|Total of all reporting groups
11216212|NCT02305238|FG000|Participant Flow|2 Weeks Adjustment|Participants received Aflibercept Intravitreal (IVT) injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216213|NCT02305238|FG001|Participant Flow|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216214|NCT02305238|FG002|Participant Flow|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
11216215|NCT02305238|OG000|Outcome|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216216|NCT02305238|OG001|Outcome|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216217|NCT02305238|EG000|Reported Event|2 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216218|NCT02305238|EG001|Reported Event|4 Weeks Adjustment|Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
11216219|NCT02305238|EG002|Reported Event|Randomization Failure|Participants entered run-in phase but discontinued the study before randomization after receiving at least one injection.
11216220|NCT02305277|BG000|Baseline|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216221|NCT02305277|BG001|Baseline|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216222|NCT02305277|BG002|Baseline|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11292387|NCT02952261|EG000|Reported Event|CT-guided Localization|"This group of participants received conventional CT-guided lung nodule localization.~CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization."
11292388|NCT02952261|EG001|Reported Event|Template-guided Localization|"Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.~template-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization."
11292389|NCT02952313|BG000|Baseline|Latera Implant|"All participants have unilateral or bilateral placement of LATERA Nasal Implants.~Nasal Implant"
11292390|NCT02952313|FG000|Participant Flow|Latera Implant|All participants have unilateral or bilateral placement of LATERA Nasal Implants.
11292391|NCT02952313|OG000|Outcome|Latera Implant|All participants have unilateral or bilateral placement of LATERA Nasal Implants.
11292392|NCT02952313|OG000|Outcome|Latera Implant|All participants with unilateral or bilateral placement of LATERA Nasal Implants.
11292393|NCT02952313|EG000|Reported Event|Latera Implant|All participants with unilateral or bilateral placement of LATERA Nasal Implants.
11292394|NCT02952586|BG000|Baseline|Avelumab + Standard of Care Chemotherapy (SOC CRT)|Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292395|NCT02952586|BG001|Baseline|Placebo + SOC CRT|Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292396|NCT02952586|BG002|Baseline|Total|Total of all reporting groups
11292397|NCT02952586|FG000|Participant Flow|Avelumab + Standard of Care Chemotherapy (SOC CRT)|Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292398|NCT02952586|FG001|Participant Flow|Placebo + SOC CRT|Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292399|NCT02952586|OG000|Outcome|Avelumab + Standard of Care Chemotherapy (SOC CRT)|Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment.
11332551|NCT03497130|OG000|Outcome|Regimen Group|After 1 week washout period using provided Dove® Soap without any moisturizer, participants in the skin care regimen group will receive Vaseline® Moisturizer, Dove® Soap, and application log. These participants will be asked to apply the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.
11332552|NCT03497130|OG001|Outcome|Control Group|"After 1 week washout period using provided Dove® Soap without any moisturizer, Individuals in the control group will continue with the provided Dove® Soap for 2 weeks.~All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use."
11292400|NCT02952586|OG001|Outcome|Placebo + SOC CRT|Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292401|NCT02952586|OG000|Outcome|Avelumab + Standard of Care Chemotherapy (SOC CRT)|Participants with LA SCCHN were administered with avelumab 10 mg/kg intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 mg/m^2 on Days 1, 22, 43 and IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292402|NCT02952586|EG000|Reported Event|Avelumab + Standard of Care Chemotherapy (SOC CRT)|Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292403|NCT02952586|EG001|Reported Event|Placebo + SOC CRT|Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment.
11292404|NCT02952820|BG000|Baseline|Placebo|Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.
11292405|NCT02952820|BG001|Baseline|Lemborexant 5 mg|Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292406|NCT02952820|BG002|Baseline|Lemborexant 10 mg|Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292407|NCT02952820|BG003|Baseline|Total|Total of all reporting groups
11292408|NCT02952820|FG000|Participant Flow|Placebo|Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 milligram (mg) or lemborexant 10 mg up to Month 12.
11292409|NCT02952820|FG001|Participant Flow|Lemborexant 5 mg|Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292410|NCT02952820|FG002|Participant Flow|Lemborexant 10 mg|Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292411|NCT02952820|OG000|Outcome|Placebo|Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.
11292412|NCT02952820|OG001|Outcome|Lemborexant 5 mg|Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292413|NCT02952820|OG002|Outcome|Lemborexant 10 mg|Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).
11292414|NCT02952820|OG000|Outcome|Lemborexant 5 mg|Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).
11292415|NCT02952820|OG001|Outcome|Lemborexant 10 mg|Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).
11292416|NCT02952820|OG000|Outcome|Placebo|Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to Lemborexant 5 mg or Lemborexant 10 mg.
11292417|NCT02952820|EG000|Reported Event|Placebo|Participants received placebo matched to lemborexant tablet, orally, once daily for up to 6 months. Then they were re-randomized to Lemborexant 5 mg or Lemborexant 10 mg.
11292418|NCT02952820|EG001|Reported Event|Lemborexant 5 mg|Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).
11292419|NCT02952820|EG002|Reported Event|Lemborexant 10 mg|Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).
11292420|NCT02952872|BG000|Baseline|Arm 1|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292421|NCT02952872|BG001|Baseline|Arm 2|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292422|NCT02952872|BG002|Baseline|Arm 3|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292423|NCT02952872|BG003|Baseline|Arm 4|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292424|NCT02952872|BG004|Baseline|Arm 5|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292425|NCT02952872|BG005|Baseline|Arm 6|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292426|NCT02952872|BG006|Baseline|Arm 7|"7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292427|NCT02952872|BG007|Baseline|Arm 8|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292428|NCT02952872|BG008|Baseline|Arm 9|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292429|NCT02952872|BG009|Baseline|Arm 10|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292430|NCT02952872|BG010|Baseline|Arm 11|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292431|NCT02952872|BG011|Baseline|Arm 12|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292432|NCT02952872|BG012|Baseline|Arm 13|"13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292433|NCT02952872|BG013|Baseline|Arm 14|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292434|NCT02952872|BG014|Baseline|Arm 15|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292435|NCT02952872|BG015|Baseline|Arm 16|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292436|NCT02952872|BG016|Baseline|Total|Total of all reporting groups
11292437|NCT02952872|FG000|Participant Flow|Arm 1|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292438|NCT02952872|FG001|Participant Flow|Arm 2|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292439|NCT02952872|FG002|Participant Flow|Arm 3|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292440|NCT02952872|FG003|Participant Flow|Arm 4|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292441|NCT02952872|FG004|Participant Flow|Arm 5|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292442|NCT02952872|FG005|Participant Flow|Arm 6|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292443|NCT02952872|FG006|Participant Flow|Arm 7|"7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292444|NCT02952872|FG007|Participant Flow|Arm 8|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292445|NCT02952872|FG008|Participant Flow|Arm 9|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292446|NCT02952872|FG009|Participant Flow|Arm 10|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292447|NCT02952872|FG010|Participant Flow|Arm 11|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292448|NCT02952872|FG011|Participant Flow|Arm 12|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292449|NCT02952872|FG012|Participant Flow|Arm 13|"13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292450|NCT02952872|FG013|Participant Flow|Arm 14|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292451|NCT02952872|FG014|Participant Flow|Arm 15|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292452|NCT02952872|FG015|Participant Flow|Arm 16|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292453|NCT02952872|OG000|Outcome|Arm 1|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292454|NCT02952872|OG001|Outcome|Arm 2|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292455|NCT02952872|OG002|Outcome|Arm 3|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292456|NCT02952872|OG003|Outcome|Arm 4|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292457|NCT02952872|OG004|Outcome|Arm 5|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292458|NCT02952872|OG005|Outcome|Arm 6|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292459|NCT02952872|OG006|Outcome|Arm 7|"7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292460|NCT02952872|OG007|Outcome|Arm 8|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292461|NCT02952872|OG008|Outcome|Arm 9|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292462|NCT02952872|OG009|Outcome|Arm 10|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292463|NCT02952872|OG010|Outcome|Arm 11|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292464|NCT02952872|OG011|Outcome|Arm 12|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292465|NCT02952872|OG012|Outcome|Arm 13|"13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292466|NCT02952872|OG013|Outcome|Arm 14|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292467|NCT02952872|OG014|Outcome|Arm 15|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292468|NCT02952872|OG015|Outcome|Arm 16|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292469|NCT02952872|EG000|Reported Event|Arm 1|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292470|NCT02952872|EG001|Reported Event|Arm 2|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292471|NCT02952872|EG002|Reported Event|Arm 3|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292472|NCT02952872|EG003|Reported Event|Arm 4|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292473|NCT02952872|EG004|Reported Event|Arm 5|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292474|NCT02952872|EG005|Reported Event|Arm 6|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292475|NCT02952872|EG006|Reported Event|Arm 7|"7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292476|NCT02952872|EG007|Reported Event|Arm 8|"Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292477|NCT02952872|EG008|Reported Event|Arm 9|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292478|NCT02952872|EG009|Reported Event|Arm 10|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292479|NCT02952872|EG010|Reported Event|Arm 11|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11336333|NCT03565068|EG021|Reported Event|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
11336334|NCT03565068|EG022|Reported Event|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
10970999|NCT00913458|FG002|Participant Flow|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
11216223|NCT02305277|BG003|Baseline|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216224|NCT02305277|BG004|Baseline|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216225|NCT02305277|BG005|Baseline|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216226|NCT02305277|BG006|Baseline|Total|Total of all reporting groups
11216227|NCT02305277|FG000|Participant Flow|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216228|NCT02305277|FG001|Participant Flow|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216229|NCT02305277|FG002|Participant Flow|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216230|NCT02305277|FG003|Participant Flow|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216231|NCT02305277|FG004|Participant Flow|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216232|NCT02305277|FG005|Participant Flow|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11216233|NCT02305277|OG000|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11216234|NCT02305277|OG001|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11216235|NCT02305277|OG002|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11216236|NCT02305277|OG003|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11216237|NCT02305277|OG004|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11216238|NCT02305277|OG005|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11216239|NCT02305277|EG000|Reported Event|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11216240|NCT02305277|EG001|Reported Event|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11216241|NCT02305277|EG002|Reported Event|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11216242|NCT02305277|EG003|Reported Event|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11216243|NCT02305277|EG004|Reported Event|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11216244|NCT02305277|EG005|Reported Event|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11216245|NCT02305316|BG000|Baseline|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11216246|NCT02305316|BG001|Baseline|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11216247|NCT02305316|BG002|Baseline|Total|Total of all reporting groups
11216248|NCT02305316|FG000|Participant Flow|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11216249|NCT02305316|FG001|Participant Flow|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11216250|NCT02305316|OG000|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11216251|NCT02305316|OG001|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11216252|NCT02305316|EG000|Reported Event|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11216253|NCT02305316|EG001|Reported Event|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11216254|NCT02305329|BG000|Baseline|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
11216255|NCT02305329|BG001|Baseline|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
11216256|NCT02305329|BG002|Baseline|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
11216257|NCT02305329|BG003|Baseline|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
11216258|NCT02305329|BG004|Baseline|Total|Total of all reporting groups
11216259|NCT02305329|FG000|Participant Flow|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
11216260|NCT02305329|FG001|Participant Flow|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
11216261|NCT02305329|FG002|Participant Flow|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
11216262|NCT02305329|FG003|Participant Flow|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
11216263|NCT02305329|OG000|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
11216264|NCT02305329|OG001|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
11292480|NCT02952872|EG011|Reported Event|Arm 12|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292481|NCT02952872|EG012|Reported Event|Arm 13|"13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292482|NCT02952872|EG013|Reported Event|Arm 14|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292483|NCT02952872|EG014|Reported Event|Arm 15|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292484|NCT02952872|EG015|Reported Event|Arm 16|"Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.~Brief Tablet-based Intervention to Address Heavy Alcohol Use: The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use."
11292485|NCT02952898|BG000|Baseline|GDC 695 Gel|"GDC 695 gel applied topically as directed.~GDC 695: GDC 695 is a topical gel."
11292486|NCT02952898|BG001|Baseline|Diclofenac Sodium Gel|"Diclofenac sodium gel, 3% applied topically as directed.~Diclofenac Sodium Gel, 3%: Diclofenac sodium gel, 3% is an FDA-approved drug."
11292487|NCT02952898|BG002|Baseline|Placebo|"Vehicle gel applied topically as directed.~Vehicle gel: Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs."
11292488|NCT02952898|BG003|Baseline|Total|Total of all reporting groups
11292489|NCT02952898|FG000|Participant Flow|GDC 695 Gel|"The test drug is GDC 695 gel applied topically as directed.~GDC 695: GDC 695 is a topical gel."
11292490|NCT02952898|FG001|Participant Flow|Diclofenac Sodium Gel|"The reference drug is Diclofenac sodium gel, 3% applied topically as directed.~Diclofenac Sodium Gel, 3%: Diclofenac sodium gel, 3% is an FDA-approved drug."
11292491|NCT02952898|FG002|Participant Flow|Placebo|"Vehicle gel applied topically as directed.~Vehicle gel: Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs."
11292492|NCT02952898|OG000|Outcome|GDC 695 Gel|"GDC 695 gel applied topically as directed.~GDC 695: GDC 695 is a topical gel."
11292493|NCT02952898|OG001|Outcome|Diclofenac Sodium Gel|"Diclofenac sodium gel, 3% applied topically as directed.~Diclofenac Sodium Gel, 3%: Diclofenac sodium gel, 3% is an FDA-approved drug."
11292494|NCT02952898|OG002|Outcome|Placebo|"Vehicle gel applied topically as directed.~Vehicle gel: Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs."
11292495|NCT02952898|EG000|Reported Event|GDC 695|"GDC 695 gel applied topically as directed.~GDC 695: GDC 695 is a topical gel."
11292496|NCT02952898|EG001|Reported Event|Diclofenac Sodium Gel|"Diclofenac sodium gel, 3% applied topically as directed.~Diclofenac Sodium Gel, 3%: Diclofenac sodium gel, 3% is an FDA-approved drug."
11292497|NCT02952898|EG002|Reported Event|Placebo|"Vehicle gel applied topically as directed.~Vehicle gel: Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs."
11292498|NCT02953262|BG000|Baseline|Brochure Only Comparison Arm|"The comparison condition only received a mailed brochure with basic My HealtheVet content during the trial.~After the completion of their telephone interview, they were offered a copy of the training guide."
11292499|NCT02953262|BG001|Baseline|Encouragement Arm 1|Participants in this encouragement condition received a brochure about the My HealtheVet portal and were also mailed a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.
11292500|NCT02953262|BG002|Baseline|Encouragement Arm 2|Participants in this encouragement condition received the My HealtheVet brochure and training guide, but were also offered optional attendance at one of several group training sessions.
11292501|NCT02953262|BG003|Baseline|Encouragement Arm 3|Participants in this encouragement condition received the same encouragement as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training session.
11292502|NCT02953262|BG004|Baseline|Total|Total of all reporting groups
11292503|NCT02953262|FG000|Participant Flow|Brochure Only Comparison Arm|"The comparison condition only received a mailed brochure with basic My HealtheVet content during the trial.~After the completion of their interview, they were offered a copy of the training guide."
11292504|NCT02953262|FG001|Participant Flow|Encouragement Arm 1|Participants in this encouragement condition received a brochure about the My HealtheVet portal and were mailed a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.
11292505|NCT02953262|FG002|Participant Flow|Encouragement Arm 2|Participants in this encouragement condition received the My HealtheVet brochure and training guide, but was also offered optional attendance at one of several group training sessions.
11292506|NCT02953262|FG003|Participant Flow|Encouragement Arm 3|Participants in this encouragement condition received the same encouragement as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training session.
11216265|NCT02305329|OG002|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
11216266|NCT02305329|OG003|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
11216267|NCT02305329|EG000|Reported Event|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
11216268|NCT02305329|EG001|Reported Event|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
11216269|NCT02305329|EG002|Reported Event|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
11216270|NCT02305329|EG003|Reported Event|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
11216271|NCT02305381|BG000|Baseline|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216272|NCT02305381|BG001|Baseline|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216273|NCT02305381|BG002|Baseline|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216274|NCT02305381|BG003|Baseline|Total|Total of all reporting groups
11216275|NCT02305381|FG000|Participant Flow|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216276|NCT02305381|FG001|Participant Flow|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216277|NCT02305381|FG002|Participant Flow|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216278|NCT02305381|OG000|Outcome|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216279|NCT02305381|OG001|Outcome|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216280|NCT02305381|OG002|Outcome|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216281|NCT02305381|EG000|Reported Event|Semaglutide 0.5 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216282|NCT02305381|EG001|Reported Event|Semaglutide 1.0 mg|Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216283|NCT02305381|EG002|Reported Event|Placebo|Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
11216284|NCT02305446|BG000|Baseline|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11216285|NCT02305446|FG000|Participant Flow|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11216286|NCT02305446|OG000|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11216287|NCT02305446|EG000|Reported Event|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11216288|NCT02305563|BG000|Baseline|ULO 600mg + LDAC - Ph1|Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216289|NCT02305563|BG001|Baseline|ULO 800mg + LDAC - Ph1|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216290|NCT02305563|BG002|Baseline|ULO 800mg + LDAC - Ph2|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216291|NCT02305563|BG003|Baseline|ULO 1000mg + LDAC - Ph2|Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216292|NCT02305563|BG004|Baseline|LDAC - Ph2|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
11216293|NCT02305563|BG005|Baseline|Total|Total of all reporting groups
11216294|NCT02305563|FG000|Participant Flow|ULO 600mg + LDAC - Ph1|Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216295|NCT02305563|FG001|Participant Flow|ULO 800mg + LDAC - Ph1|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11292507|NCT02953262|OG000|Outcome|Brochure Only Comparison Arm|"The Comparison condition will only receive a mailed brochure with basic My HealtheVet content during the trial. (The training guide will be mailed to them after completion of the 6-month interview.)~Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content."
11216296|NCT02305563|FG002|Participant Flow|ULO 800mg + LDAC - Ph2|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216297|NCT02305563|FG003|Participant Flow|ULO 1000mg + LDAC - Ph2|Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216298|NCT02305563|FG004|Participant Flow|LDAC - Ph2|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
11216299|NCT02305563|OG000|Outcome|ULO 600mg + LDAC - Ph1|Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216300|NCT02305563|OG001|Outcome|ULO 800mg + LDAC - Ph1|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216301|NCT02305563|OG000|Outcome|ULO 800mg + LDAC - Ph2|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216302|NCT02305563|OG001|Outcome|ULO 1000mg + LDAC - Ph2|Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216303|NCT02305563|OG002|Outcome|LDAC - Ph2|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
11216304|NCT02305563|OG002|Outcome|ULO 800mg + LDAC - Ph2|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216305|NCT02305563|OG003|Outcome|ULO 1000mg + LDAC - Ph2|Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216306|NCT02305563|OG004|Outcome|LDAC - Ph2|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
11216307|NCT02305563|OG000|Outcome|LDAC - Ph2|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
11216308|NCT02305563|EG000|Reported Event|Ulo 600mg+LDAC|Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216309|NCT02305563|EG001|Reported Event|Ulo 800mg+LDAC|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
11216310|NCT02305563|EG002|Reported Event|Ulocuplumab 800mg + LDAC 20mg BID|Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216311|NCT02305563|EG003|Reported Event|Ulocuplumab 1000mg + LDAC 20mg BID|Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
11216312|NCT02305563|EG004|Reported Event|LDAC 20mg BID|Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission.
11216313|NCT02305732|BG000|Baseline|INTERCEPT|Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
11216314|NCT02305732|FG000|Participant Flow|INTERCEPT|Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
11216315|NCT02305732|OG000|Outcome|Transfused INTERCEPT Components|Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
11216316|NCT02305732|OG000|Outcome|INTERCEPT|Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
11216317|NCT02305732|EG000|Reported Event|INTERCEPT|Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
11216318|NCT02305758|BG000|Baseline|Veliparib + Modified FOLFIRI ± Bevacizumab|Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.
11216319|NCT02305758|BG001|Baseline|Placebo + FOLFIRI ± Bevacizumab|Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.
11216320|NCT02305758|BG002|Baseline|Total|Total of all reporting groups
11216321|NCT02305758|FG000|Participant Flow|Veliparib + Modified FOLFIRI ± Bevacizumab|Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.
11292508|NCT02953262|OG001|Outcome|Encouragement Arm 1|"Participants in this encouragement condition will receive a mailed brochure with basic My HealtheVet content and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.~Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.~Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content."
11292509|NCT02953262|OG002|Outcome|Encouragement Arm 2|"Participants in this encouragement condition will receive the same brochure and training guide as Arm 1 but will also be offered optional attendance at one of several group training sessions.~Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.~Supported Adopted Intervention 2: Participants will be offered optional attendance at a group training session in addition to receiving the brochure and training guide by mail. These sessions will be offered at a computer lab at the VA hospital.~Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content."
11292510|NCT02953262|OG003|Outcome|Encouragement Arm 3|"Participants in this encouragement condition will receive the same as in Arm 2 (brochure, training guide, and group training offer) but will also be offered a one-on-one My HealtheVet training session.~Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.~Supported Adopted Intervention 2: Participants will be offered optional attendance at a group training session in addition to receiving the brochure and training guide by mail. These sessions will be offered at a computer lab at the VA hospital.~Supported Adopted Intervention 3: Participants will also be offered a one-on-one My HealtheVet training session in addition to the brochure, training guide, and offer of group training session.~Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content."
11292511|NCT02953262|OG000|Outcome|Brochure Only Comparison Arm|"The Comparison condition will only receive a mailed brochure with basic My HealtheVet content during the trial. (The training guide will be mailed to them after completion of the interview at the end.)~My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content."
11292512|NCT02953262|OG001|Outcome|Encouragement Arm 1|"Participants in this encouragement condition will receive a mailed brochure with basic My HealtheVet content and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.~My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content.~My HealtheVet Training Guide for Veterans Living with Diabetes: Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features"
11292513|NCT02953262|OG002|Outcome|Encouragement Arm 2|"Participants in this encouragement condition will receive the same brochure and training guide as Arm 1 but will also be offered optional attendance at one of several group training sessions.~My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content.~My HealtheVet Training Guide for Veterans Living with Diabetes: Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features~My HealtheVet Group Training: Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes"
11292514|NCT02953262|OG003|Outcome|Encouragement Arm 3|"Participants in this encouragement condition will receive the same as in Arm 2 (brochure, training guide, and group training offer) but will also be offered a one-on-one My HealtheVet training session.~My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content.~My HealtheVet Training Guide for Veterans Living with Diabetes: Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features~My HealtheVet Group Training: Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes~My HealtheVet Individual Training: Participants will be invited to participate in a one-on-one training to learn how to use My HealtheVet to help manage their diabetes at a time of their convenience."
11292515|NCT02953262|EG000|Reported Event|Comparison Arm|"The Comparison condition received a mailed brochure with basic My HealtheVet information.~They were offered a training guide at the end of the study (after their interview)."
11292516|NCT02953262|EG001|Reported Event|Encouragement Arm 1|Participants in this encouragement condition received the mailed brochure and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.
11292517|NCT02953262|EG002|Reported Event|Encouragement Arm 2|Participants in this encouragement condition received the brochure and the same training guide as Arm 1 but were also offered optional attendance at one of several group training sessions.
11292518|NCT02953262|EG003|Reported Event|Encouragement Arm 3|Participants in this encouragement condition received the same as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training
11292519|NCT02953314|BG000|Baseline|Part A|Participants weighing <25 kg received TEZ 50 mg/IVA 75 mg for 14 days. Participants weighing ≥25 kg received TEZ 50 mg/IVA 150 mg for 14 days.
11216322|NCT02305758|FG001|Participant Flow|Placebo + FOLFIRI ± Bevacizumab|Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.
11216323|NCT02305758|OG000|Outcome|Veliparib + Modified FOLFIRI ± Bevacizumab|Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.
11216324|NCT02305758|OG001|Outcome|Placebo + FOLFIRI ± Bevacizumab|Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.
11216325|NCT02305758|EG000|Reported Event|Veliparib + Modified FOLFIRI ± Bevacizumab|Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.
11216326|NCT02305758|EG001|Reported Event|Placebo + FOLFIRI ± Bevacizumab|Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m^2 (up to 15-minute infusion) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.
11216327|NCT02305797|BG000|Baseline|EDG004|"EDG004~EDG004: EDG004"
11216328|NCT02305797|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo"
11216329|NCT02305797|BG002|Baseline|Total|Total of all reporting groups
11216330|NCT02305797|FG000|Participant Flow|EDG004|"EDG004~EDG004: EDG004~Extended release lorazepam capsules dosed once daily at 1, 2, 3, 4, 5, or 6 mg/day."
11216331|NCT02305797|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11216332|NCT02305797|OG000|Outcome|EDG004|"EDG004~EDG004: EDG004"
11216333|NCT02305797|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo"
11216334|NCT02305797|EG000|Reported Event|EDG004|"EDG004~EDG004: EDG004"
11216335|NCT02305797|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11216336|NCT02305849|BG000|Baseline|Peficitinib 100 mg|Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216337|NCT02305849|BG001|Baseline|Peficitinib 150 mg|Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216338|NCT02305849|BG002|Baseline|Placebo|Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216339|NCT02305849|BG003|Baseline|Total|Total of all reporting groups
11216340|NCT02305849|FG000|Participant Flow|Peficitinib 100 mg|Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216341|NCT02305849|FG001|Participant Flow|Peficitinib 150 mg|Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216342|NCT02305849|FG002|Participant Flow|Placebo / Peficitinib 100 mg|Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216343|NCT02305849|FG003|Participant Flow|Placebo / Peficitinib 150 mg|Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216344|NCT02305849|OG000|Outcome|Placebo|Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216345|NCT02305849|OG001|Outcome|Peficitinib 100 mg|Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216346|NCT02305849|OG002|Outcome|Peficitinib 150 mg|Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216347|NCT02305849|OG000|Outcome|Peficitinib 100 mg|Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216348|NCT02305849|OG001|Outcome|Peficitinib 150 mg|Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
11216349|NCT02305849|OG002|Outcome|Placebo / Peficitinib 100 mg at Week 12|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
11216350|NCT02305849|OG003|Outcome|Placebo / Peficitinib 150 mg at Week 12|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
11216351|NCT02305849|OG004|Outcome|Placebo / Peficitinib 100 mg at Week 28|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
11216352|NCT02305849|OG005|Outcome|Placebo / Peficitinib 150 mg at Week 28|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
11216353|NCT02305849|OG001|Outcome|Peficitinib 100 mg|Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks
11216354|NCT02305849|OG002|Outcome|Peficitinib 150 mg|Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks
11216355|NCT02305849|OG002|Outcome|Placebo / Peficitinib 100 mg|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216356|NCT02305849|OG003|Outcome|Placebo / Peficitinib 150 mg|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
11216357|NCT02305849|OG003|Outcome|Placebo / Peficitinib 100 mg at Week 12|Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
11216358|NCT02305849|OG004|Outcome|Placebo / Peficitinib 150 mg at Week 12|Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
11216359|NCT02305849|EG000|Reported Event|Week 0 to Week 12: Placebo|Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12.
11216360|NCT02305849|EG001|Reported Event|Week 0 to Week 12: Peficitinib 100 mg|Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.
11216361|NCT02305849|EG002|Reported Event|Week 0 to Week 12: Peficitinib 150 mg|Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.
11216362|NCT02305849|EG003|Reported Event|Week 12 to Week 28: Placebo|Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
11216363|NCT02305849|EG004|Reported Event|Week 12 to Week 28: Peficitinib 100 mg|Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
11216364|NCT02305849|EG005|Reported Event|Week 12 to Week 28: Peficitinib 150 mg|Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
11216365|NCT02305849|EG006|Reported Event|Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 28.
11216366|NCT02305849|EG007|Reported Event|Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 28.
11216367|NCT02305849|EG008|Reported Event|Week 28 to Week 52: Peficitinib 100 mg|Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.
11216368|NCT02305849|EG009|Reported Event|Week 28 to Week 52: Peficitinib 150 mg|Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.
11216369|NCT02305849|EG010|Reported Event|Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 52.
11216370|NCT02305849|EG011|Reported Event|Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 52.
11216371|NCT02305849|EG012|Reported Event|Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28|Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
11216372|NCT02305849|EG013|Reported Event|Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28|Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
11216373|NCT02305888|BG000|Baseline|LEO 43204 0.018% Face/Chest|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
11216374|NCT02305888|BG001|Baseline|LEO 43204 0.037% Scalp|Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
11216375|NCT02305888|BG002|Baseline|LEO 43204 0.1% Trunk/Extremities|Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
11216376|NCT02305888|BG003|Baseline|Total|Total of all reporting groups
11216377|NCT02305888|FG000|Participant Flow|LEO 43204 0.018% Face/Chest|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
11292520|NCT02953314|BG001|Baseline|Part B|"Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg as fixed dose combination in the morning and IVA 75 mg in the evening for 24 weeks.~Participants weighing ≥40 kg received TEZ 100 mg/IVA 150 mg as fixed dose combination in the morning and IVA 150 mg in the evening for 24 weeks."
11292521|NCT02953314|BG002|Baseline|Total|Total of all reporting groups
11292522|NCT02953314|FG000|Participant Flow|Part A|"Participants weighing <25 kg received TEZ 50 mg/IVA 75 mg for 14 days.~Participants weighing ≥25 kg received TEZ 50 mg/IVA 150 mg for 14 days."
11292523|NCT02953314|FG001|Participant Flow|Part B|"Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg as fixed dose combination in the morning and IVA 75 mg orally in the evening for 24 weeks.~Participants weighing ≥40 kg received TEZ 100 mg/IVA 150 mg as fixed dose combination in the morning and IVA 150 mg in the evening for 24 weeks."
11292524|NCT02953314|OG000|Outcome|Part A|Participants weighing <25 kg received TEZ 50 mg/IVA 75 mg for 14 days. Participants weighing ≥25 kg received TEZ 50 mg/IVA 150 mg for 14 days.
11292525|NCT02953314|OG000|Outcome|Part B|"Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg as fixed dose combination in the morning and IVA 75 mg in the evening for 24 weeks.~Participants weighing ≥40 kg received TEZ 100 mg/IVA 150 mg as fixed dose combination in the morning and IVA 150 mg in the evening for 24 weeks."
11292526|NCT02953314|EG000|Reported Event|Part A|Participants weighing <25 kg received TEZ 50 mg/IVA 75 mg for 14 days. Participants weighing ≥25 kg received TEZ 50 mg/IVA 150 mg for 14 days.
11292527|NCT02953314|EG001|Reported Event|Part B|"Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg as fixed dose combination in the morning and IVA 75 mg orally in the evening for 24 weeks.~Participants weighing ≥40 kg received TEZ 100 mg/IVA 150 mg as fixed dose combination in the morning and IVA 150 mg in the evening for 24 weeks."
11292528|NCT02953418|BG000|Baseline|Radiofrequency Ablation|"Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.~Radiofrequency ablation: RFA"
11292529|NCT02953418|FG000|Participant Flow|Radiofrequency Ablation|"Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.~Radiofrequency ablation: RFA"
11292530|NCT02953418|OG000|Outcome|Radiofrequency Ablation|"Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.~Radiofrequency ablation: RFA"
11292531|NCT02953418|EG000|Reported Event|Radiofrequency Ablation|"Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.~Radiofrequency ablation: RFA"
11292532|NCT02953548|BG000|Baseline|GWP42003-P OS|Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292533|NCT02953548|FG000|Participant Flow|Cohort 1: GWP42003-P OS|Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
11292534|NCT02953548|FG001|Participant Flow|Cohort 2: GWP42003-P OS|Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292535|NCT02953548|OG000|Outcome|GWP42003-P OS|Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292536|NCT02953548|OG000|Outcome|GWP42003-P OS|Participants received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292537|NCT02953548|OG000|Outcome|Cohort 1: GWP42003-P OS|Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
11292538|NCT02953548|OG001|Outcome|Cohort 2: GWP42003-P OS|Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292539|NCT02953548|EG000|Reported Event|GWP42003-P OS|Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
11292540|NCT02953561|BG000|Baseline|Treatment (Azacitidine, Avelumab)|"Patients receive azacitidine SC or IV over 10-40 minutes on days 1-7 or on days 1-5 and 8-9. Patients also receive avelumab IV over 60 minutes on days 1 and 14 for 4 courses (or until complete response) and on day 1 for subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Avelumab: Given IV~Azacitidine: Given SC or IV~Laboratory Biomarker Analysis: Correlative studies"
11292541|NCT02953561|FG000|Participant Flow|Treatment (Azacitidine, Avelumab)|"Patients receive azacitidine SC or IV over 10-40 minutes on days 1-7 or on days 1-5 and 8-9. Patients also receive avelumab IV over 60 minutes on days 1 and 14 for 4 courses (or until complete response) and on day 1 for subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Avelumab: Given IV~Azacitidine: Given subcutaneous or IV~Laboratory Biomarker Analysis: Correlative studies"
11292542|NCT02953561|OG000|Outcome|Treatment (Azacitidine, Avelumab)|"Patients receive azacitidine SC or IV over 10-40 minutes on days 1-7 or on days 1-5 and 8-9. Patients also receive avelumab IV over 60 minutes on days 1 and 14 for 4 courses (or until complete response) and on day 1 for subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Avelumab: Given IV~Azacitidine: Given SC or IV~Laboratory Biomarker Analysis: Correlative studies"
11292543|NCT02953561|EG000|Reported Event|Treatment (Azacitidine, Avelumab)|"Patients receive azacitidine SC or IV over 10-40 minutes on days 1-7 or on days 1-5 and 8-9. Patients also receive avelumab IV over 60 minutes on days 1 and 14 for 4 courses (or until complete response) and on day 1 for subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Avelumab: Given IV~Azacitidine: Given SC or IV~Laboratory Biomarker Analysis: Correlative studies"
11292544|NCT02953639|BG000|Baseline|Placebo|Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
11292545|NCT02953639|BG001|Baseline|Basmisanil 80mg BID|Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
11292546|NCT02953639|BG002|Baseline|Basmisanil 240mg BID|Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
11292547|NCT02953639|BG003|Baseline|Total|Total of all reporting groups
11292548|NCT02953639|FG000|Participant Flow|Placebo|Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
11292549|NCT02953639|FG001|Participant Flow|Basmisanil 80mg BID|Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
11292550|NCT02953639|FG002|Participant Flow|Basmisanil 240mg BID|Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
11292551|NCT02953639|OG000|Outcome|Placebo|Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
11292552|NCT02953639|OG001|Outcome|Basmisanil 240mg BID|Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
11292553|NCT02953639|OG001|Outcome|Basmisanil 80mg BID|Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
11292554|NCT02953639|OG002|Outcome|Basmisanil 240mg BID|Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
11292555|NCT02953639|OG000|Outcome|Basmisanil 80mg BID|Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
11292556|NCT02953639|EG000|Reported Event|Placebo|Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
11292557|NCT02953639|EG001|Reported Event|Basmisanil 80mg BID|Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
11292558|NCT02953639|EG002|Reported Event|Basmisanil 240mg BID|Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
11292559|NCT02953678|BG000|Baseline|Ruxolitinib in Combination With Corticosteroids|Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
11292560|NCT02953678|FG000|Participant Flow|Ruxolitinib in Combination With Corticosteroids|Participants began oral administration of ruxolitinib at 5 mg twice a day (BID); if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
11292561|NCT02953678|OG000|Outcome|Ruxolitinib in Combination With Corticosteroids|Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
11292562|NCT02953678|OG000|Outcome|Ruxolitinib in Combination With Corticosteroids|Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
11292563|NCT02953678|EG000|Reported Event|Ruxolitinib in Combination With Corticosteroids|Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
11292564|NCT02953782|BG000|Baseline|Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292565|NCT02953782|BG001|Baseline|Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11336335|NCT03565068|EG023|Reported Event|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
11336336|NCT03565068|EG024|Reported Event|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
10971000|NCT00913458|FG003|Participant Flow|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
10971001|NCT00913458|FG004|Participant Flow|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
11292566|NCT02953782|BG002|Baseline|Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292567|NCT02953782|BG003|Baseline|Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292568|NCT02953782|BG004|Baseline|Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292569|NCT02953782|BG005|Baseline|Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11332553|NCT03497130|EG000|Reported Event|Regimen Group|After 1 week washout period using provided Dove® Soap without any moisturizer, participants in the skin care regimen group will receive Vaseline® Moisturizer, Dove® Soap, and application log. These participants will be asked to apply the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.
10971002|NCT00913458|FG005|Participant Flow|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
10971003|NCT00913458|FG006|Participant Flow|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
10971004|NCT00913458|OG000|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
11292570|NCT02953782|BG006|Baseline|Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292571|NCT02953782|BG007|Baseline|Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292572|NCT02953782|BG008|Baseline|Total|Total of all reporting groups
11292573|NCT02953782|FG000|Participant Flow|Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD).
11332554|NCT03497130|EG001|Reported Event|Control Group|"After 1 week washout period using provided Dove® Soap without any moisturizer, Individuals in the control group will continue with the provided Dove® Soap for 2 weeks.~All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use."
11332555|NCT03497429|BG000|Baseline|Cohort 1: Niraparib 200 mg|Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332556|NCT03497429|BG001|Baseline|Cohort 2: Niraparib 300 mg|Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332557|NCT03497429|BG002|Baseline|Total|Total of all reporting groups
11332558|NCT03497429|FG000|Participant Flow|Cohort 1: Niraparib 200 mg|Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332559|NCT03497429|FG001|Participant Flow|Cohort 2: Niraparib 300 mg|Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332560|NCT03497429|OG000|Outcome|Cohort 1: Niraparib 200 mg|Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332561|NCT03497429|OG001|Outcome|Cohort 2: Niraparib 300 mg|Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11216378|NCT02305888|FG001|Participant Flow|LEO 43204 0.037% Scalp|Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
11216379|NCT02305888|FG002|Participant Flow|LEO 43204 0.1% Trunk/Extremities|Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
11216380|NCT02305888|OG000|Outcome|LEO 43204 0.018% Face/Chest|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
11216381|NCT02305888|OG001|Outcome|LEO 43204 0.037% Scalp|Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
11216382|NCT02305888|OG002|Outcome|LEO 43204 0.1% Trunk/Extremities|Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
11216383|NCT02305888|EG000|Reported Event|LEO 43204 0.018% Face/Chest|Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
11216384|NCT02305888|EG001|Reported Event|LEO 43204 0.037% Scalp|Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
11216385|NCT02305888|EG002|Reported Event|LEO 43204 0.1% Trunk/Extremities|Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
11292574|NCT02953782|FG001|Participant Flow|Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292575|NCT02953782|FG002|Participant Flow|Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292576|NCT02953782|FG003|Participant Flow|Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292577|NCT02953782|FG004|Participant Flow|Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292578|NCT02953782|FG005|Participant Flow|Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced colorectal cancer (CRC) who were KRAS wild type (KRASwt) and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292579|NCT02953782|FG006|Participant Flow|Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRAS mutation (KRASm) who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11332562|NCT03497429|EG000|Reported Event|Cohort 1: Niraparib 200 mg|Niraparib 200 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11332563|NCT03497429|EG001|Reported Event|Cohort 2: Niraparib 300 mg|Niraparib 300 mg, capsule, orally, once daily, in each 21-day treatment cycle until objective disease progression, unacceptable toxicity or until study discontinuation due to any other reasons.
11292580|NCT02953782|FG007|Participant Flow|Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292581|NCT02953782|OG000|Outcome|Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292582|NCT02953782|OG001|Outcome|Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292583|NCT02953782|OG002|Outcome|Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292584|NCT02953782|OG003|Outcome|Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292585|NCT02953782|OG004|Outcome|Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292586|NCT02953782|OG005|Outcome|Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m^2 infusions given over 60 minutes.
11292587|NCT02953782|OG004|Outcome|Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292588|NCT02953782|OG005|Outcome|Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292589|NCT02953782|OG006|Outcome|Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292590|NCT02953782|OG007|Outcome|Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292591|NCT02953782|OG008|Outcome|Magrolimab Priming Dose Only|Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
11292592|NCT02953782|OG000|Outcome|KRASwt CRC|All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
11292593|NCT02953782|OG001|Outcome|KRASm CRC|All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
11292594|NCT02953782|OG007|Outcome|Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2|Participants with advanced CRC with KRAS mutation who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
11292595|NCT02953782|EG000|Reported Event|Magrolimab 10 mg/kg|Participants who received magrolimab maintenance dose of 10 mg/kg in combination with cetuximab in any part of the study.
11292596|NCT02953782|EG001|Reported Event|Magrolimab 20 mg/kg|Participants who received magrolimab maintenance dose of 20 mg/kg in combination with cetuximab in any part of the study.
11292597|NCT02953782|EG002|Reported Event|Magrolimab 30 mg/kg|Participants who received magrolimab maintenance dose of 30 mg/kg in combination with cetuximab in any part of the study.
11292598|NCT02953782|EG003|Reported Event|Magrolimab 45 mg/kg|Participants who received magrolimab maintenance dose of 45 mg/kg in combination with cetuximab in any part of the study.
11292599|NCT02953782|EG004|Reported Event|Magrolimab Priming Dose Only|Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
11332564|NCT03497585|BG000|Baseline|Activity Pacing Framework|"Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.~Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies."
11336337|NCT03565068|EG025|Reported Event|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
11336338|NCT03565068|EG026|Reported Event|Panel D (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
11292600|NCT02953821|BG000|Baseline|Placebo Gel|"Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks~Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)"
11292601|NCT02953821|BG001|Baseline|Acthar Gel|"Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks~Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)"
11292602|NCT02953821|BG002|Baseline|Total|Total of all reporting groups
11292603|NCT02953821|FG000|Participant Flow|Placebo Gel|"Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks~Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)"
11292604|NCT02953821|FG001|Participant Flow|Acthar Gel|"Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks~Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)"
11292605|NCT02953821|OG000|Outcome|Placebo Gel|"Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks~Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)"
11292606|NCT02953821|OG001|Outcome|Acthar Gel|"Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks~Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)"
11292607|NCT02953821|OG000|Outcome|Placebo Gel|Participants receive Placebo Gel
11292608|NCT02953821|OG001|Outcome|Acthar Gel|Participants receive Acthar Gel
11292609|NCT02953821|EG000|Reported Event|Placebo Gel|Participants receive Placebo Gel
11292610|NCT02953821|EG001|Reported Event|Acthar Gel|Participants receive Acthar Gel
11292611|NCT02953860|BG000|Baseline|Fulvestrant With Enzalutamide|"500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.~Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment."
11292612|NCT02953860|FG000|Participant Flow|Fulvestrant With Enzalutamide|"500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.~Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment."
11292613|NCT02953860|OG000|Outcome|Fulvestrant With Enzalutamide|"500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.~Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment."
11292614|NCT02953860|EG000|Reported Event|Fulvestrant With Enzalutamide|"500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.~Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment."
11292615|NCT02953873|BG000|Baseline|Conversion Arm|"Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily~Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL~Mycophenolate mofetil: ≥500mg twice a day~Prednisone: goal dose 5mg daily~Mycophenolate Sodium: ≥360mg twice a day"
11292616|NCT02953873|FG000|Participant Flow|Conversion Arm|"Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily~Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL~Mycophenolate mofetil: ≥500mg twice a day~Prednisone: goal dose 5mg daily~Mycophenolate Sodium: ≥360mg twice a day"
11292617|NCT02953873|OG000|Outcome|Conversion Arm|"Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily~Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL~Mycophenolate mofetil: ≥500mg twice a day~Prednisone: goal dose 5mg daily~Mycophenolate Sodium: ≥360mg twice a day"
11292618|NCT02953873|EG000|Reported Event|Conversion Arm|"Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily~Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL~Mycophenolate mofetil: ≥500mg twice a day~Prednisone: goal dose 5mg daily~Mycophenolate Sodium: ≥360mg twice a day"
10822213|NCT00075270|EG001|Reported Event|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
11292619|NCT02953886|BG000|Baseline|Silver Diamine Fluoride (SDF)|"Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.~Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet"
11292620|NCT02953886|FG000|Participant Flow|Silver Diamine Fluoride (SDF)|"Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.~Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet"
11292621|NCT02953886|OG000|Outcome|Silver Diamine Fluoride (SDF)|"Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.~Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet"
11292622|NCT02953886|EG000|Reported Event|Silver Diamine Fluoride (SDF)|"Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.~Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet"
11292623|NCT02953938|BG000|Baseline|Ranibizumab 0.5 mg|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
11292624|NCT02953938|BG001|Baseline|Ranibizumab 0.5 mg and Laser|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment
11292625|NCT02953938|BG002|Baseline|Total|Total of all reporting groups
11292626|NCT02953938|FG000|Participant Flow|Ranibizumab 0.5 mg|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
11292627|NCT02953938|FG001|Participant Flow|Ranibizumab 0.5 mg and Laser|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment
11292628|NCT02953938|OG000|Outcome|Ranibizumab 0.5 mg|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
11292629|NCT02953938|OG001|Outcome|Ranibizumab 0.5 mg Laser|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
11292630|NCT02953938|EG000|Reported Event|Ranibizumab 0.5 mg|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL
11292631|NCT02953938|EG001|Reported Event|Ranibizumab 0.5 mg+ Laser|0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.
11292632|NCT02953938|EG002|Reported Event|Total|Total
10822214|NCT00075335|BG000|Baseline|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
11292633|NCT02954172|BG000|Baseline|Bevacizumab in Combination With Paclitaxel/Carboplatin|Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292634|NCT02954172|BG001|Baseline|IBI305 in Combination With Paclitaxel/Carboplatin|Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292635|NCT02954172|BG002|Baseline|Total|Total of all reporting groups
11292636|NCT02954172|FG000|Participant Flow|Bevacizumab in Combination With Paclitaxel/Carboplatin|Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292637|NCT02954172|FG001|Participant Flow|IBI305 in Combination With Paclitaxel/Carboplatin|Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292638|NCT02954172|OG000|Outcome|Bevacizumab in Combination With Paclitaxel/Carboplatin|Drug Bevacizumab 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292639|NCT02954172|OG001|Outcome|IBI305 in Combination With Paclitaxel/Carboplatin|Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292640|NCT02954172|OG001|Outcome|IBI305 in Combination With Paclitaxel/Carboplatin|Drug IBI30515mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292641|NCT02954172|EG000|Reported Event|Bevacizumab in Combination With Paclitaxel/Carboplatin|Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292642|NCT02954172|EG001|Reported Event|IBI305 in Combination With Paclitaxel/Carboplatin|Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
11292643|NCT02954198|BG000|Baseline|Control: Envarsus + MMF|"Envarsus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months~Tacrolimus: goal trough level 5-12ng/mL~Prednisone: goal dose 5mg QD~Mycophenolate mofetil: goal dose 1g BID"
11292644|NCT02954198|BG001|Baseline|Intervention: Envarsus + Everoliumus|"Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months~Tacrolimus: goal trough level 2-5 ng/mL~Prednisone: goal dose 5mg QD~Everolimus: goal trough level 3-8ng/mL"
11292645|NCT02954198|BG002|Baseline|Total|Total of all reporting groups
11292646|NCT02954198|FG000|Participant Flow|Control: Envarsus + MMF|"Envarsus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months~Tacrolimus: goal trough level 5-12ng/mL~Prednisone: goal dose 5mg QD~Mycophenolate mofetil: goal dose 1g BID"
11292647|NCT02954198|FG001|Participant Flow|Intervention: Envarsus + Everoliumus|"Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months~Tacrolimus: goal trough level 2-5 ng/mL~Prednisone: goal dose 5mg QD~Everolimus: goal trough level 3-8ng/mL"
11292648|NCT02954198|OG000|Outcome|Control: Envarsus + MMF|"Envarsus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months~Tacrolimus: goal trough level 5-12ng/mL~Prednisone: goal dose 5mg QD~Mycophenolate mofetil: goal dose 1g BID"
11292649|NCT02954198|OG001|Outcome|Intervention: Envarsus + Everoliumus|"Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months~Tacrolimus: goal trough level 2-5 ng/mL~Prednisone: goal dose 5mg QD~Everolimus: goal trough level 3-8ng/mL"
11292650|NCT02954198|EG000|Reported Event|Control: Envarsus + MMF|"Envarsus Daily (5 -12ng/mL) + mycophenolate mofetil 1g BID + prednisone x 6 months~Tacrolimus: goal trough level 5-12ng/mL~Prednisone: goal dose 5mg QD~Mycophenolate mofetil: goal dose 1g BID"
11292651|NCT02954198|EG001|Reported Event|Intervention: Envarsus + Everoliumus|"Envarsus Daily (2-5ng/mL) + Everolimus Daily (3-8ng/mL) + prednisone x 6 months~Tacrolimus: goal trough level 2-5 ng/mL~Prednisone: goal dose 5mg QD~Everolimus: goal trough level 3-8ng/mL"
11292652|NCT02954354|BG000|Baseline|Baloxavir|"Participants aged 20 to 64 years received 40 mg or 80 mg baloxavir (depending on weight) orally on Day 1 and placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.~Participants aged 12 to 19 years received 40 mg or 80 mg baloxavir (depending on weight) on Day 1."
11292653|NCT02954354|BG001|Baseline|Placebo|Participants aged 20 to 64 years received placebo to baloxavir on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5. Participants aged 12 to 19 years received placebo to baloxavir on Day 1.
11292654|NCT02954354|BG002|Baseline|Oseltamivir|Participants aged 20 to 64 years received 75 mg oseltamivir orally BID on Days 1 to 5 and placebo to baloxavir on Day 1.
11292655|NCT02954354|BG003|Baseline|Total|Total of all reporting groups
11292656|NCT02954354|FG000|Participant Flow|Baloxavir|"Participants aged 20 to 64 years received 40 mg or 80 mg baloxavir (depending on weight) orally on Day 1 and placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.~Participants aged 12 to 19 years received 40 mg or 80 mg baloxavir (depending on weight) on Day 1."
11292657|NCT02954354|FG001|Participant Flow|Placebo|Participants aged 20 to 64 years received placebo to baloxavir on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5. Participants aged 12 to 19 years received placebo to baloxavir on Day 1.
11292658|NCT02954354|FG002|Participant Flow|Oseltamivir|Participants aged 20 to 64 years received 75 mg oseltamivir orally BID on Days 1 to 5 and placebo to baloxavir on Day 1.
11292659|NCT02954354|OG000|Outcome|Baloxavir|"Participants aged 20 to 64 years received 40 mg or 80 mg baloxavir (depending on weight) orally on Day 1 and placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.~Participants aged 12 to 19 years received 40 mg or 80 mg baloxavir (depending on weight) on Day 1."
11292660|NCT02954354|OG001|Outcome|Placebo|Participants aged 20 to 64 years received placebo to baloxavir on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5. Participants aged 12 to 19 years received placebo to baloxavir on Day 1.
11292661|NCT02954354|OG000|Outcome|Baloxavir|Participants aged 20 to 64 years received 40 mg or 80 mg baloxavir (depending on weight) orally on Day 1 and placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.
11292662|NCT02954354|OG001|Outcome|Oseltamivir|Participants aged 20 to 64 years received 75 mg oseltamivir orally BID on Days 1 to 5 and placebo to baloxavir on Day 1.
11292663|NCT02954354|OG002|Outcome|Oseltamivir|Participants aged 20 to 64 years received 75 mg oseltamivir orally BID on Days 1 to 5 and placebo to baloxavir on Day 1.
11292664|NCT02954354|EG000|Reported Event|Baloxavir|"Participants aged 20 to 64 years received 40 mg or 80 mg baloxavir (depending on weight) orally on Day 1 and placebo to oseltamivir orally twice a day (BID) on Days 1 to 5.~Participants aged 12 to 19 years received 40 mg or 80 mg baloxavir (depending on weight) on Day 1."
11292665|NCT02954354|EG001|Reported Event|Placebo|Participants aged 20 to 64 years received placebo to baloxavir on Day 1 and placebo to oseltamivir orally twice a day on Days 1 to 5. Participants aged 12 to 19 years received placebo to baloxavir on Day 1.
11292666|NCT02954354|EG002|Reported Event|Oseltamivir|Participants aged 20 to 64 years received 75 mg oseltamivir orally BID on Days 1 to 5 and placebo to baloxavir on Day 1.
11292667|NCT02954458|BG000|Baseline|Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292668|NCT02954458|BG001|Baseline|Non-teduglutide/Teduglutide Treatment (NTT/TED)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.
11292669|NCT02954458|BG002|Baseline|Teduglutide /Non-teduglutide Treatment (TED/NTT)|Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292670|NCT02954458|BG003|Baseline|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292671|NCT02954458|BG004|Baseline|Total|Total of all reporting groups
11292672|NCT02954458|FG000|Participant Flow|Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292673|NCT02954458|FG001|Participant Flow|Non-teduglutide/Teduglutide Treatment (NTT/TED)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.
11292674|NCT02954458|FG002|Participant Flow|Teduglutide /Non-teduglutide Treatment (TED/NTT)|Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292675|NCT02954458|FG003|Participant Flow|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292676|NCT02954458|OG000|Outcome|Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292677|NCT02954458|OG001|Outcome|Non-teduglutide/Teduglutide Treatment (NTT/TED)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.
11292678|NCT02954458|OG002|Outcome|Teduglutide /Non-teduglutide Treatment (TED/NTT)|Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292679|NCT02954458|OG003|Outcome|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292680|NCT02954458|OG000|Outcome|Non-teduglutide/Teduglutide Treatment (NTT/TED)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.
11292681|NCT02954458|OG001|Outcome|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292682|NCT02954458|OG001|Outcome|Teduglutide /Non-teduglutide Treatment (TED/NTT)|Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292683|NCT02954458|OG002|Outcome|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292684|NCT02954458|EG000|Reported Event|Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292685|NCT02954458|EG001|Reported Event|Non-teduglutide/Teduglutide Treatment (NTT/TED)|Participants who participated in standard of care arm in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.
11292686|NCT02954458|EG002|Reported Event|Teduglutide /Non-teduglutide Treatment (TED/NTT)|Participants who received teduglutide in the core study TEDC14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.
11292687|NCT02954458|EG003|Reported Event|Teduglutide/Teduglutide Treatment (TED/TED)|Participants who received teduglutide in the core study TED-C14-006 [NCT02682381] or SHP633-301 [NCT03571516] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.
11292688|NCT02954575|BG000|Baseline|Wilate|SAF population (All patients who received at least one administration of Wilate during the study (N=55)
11336339|NCT03565211|BG000|Baseline|Progesterone Vaginal Ring|Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
11336340|NCT03565211|FG000|Participant Flow|Progesterone Vaginal Ring|Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
11336341|NCT03565211|OG000|Outcome|Progesterone Vaginal Ring|Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
11336342|NCT03565211|EG000|Reported Event|Progesterone Vaginal Ring|Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
11336343|NCT03565315|BG000|Baseline|Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
11336344|NCT03565315|BG001|Baseline|Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
11336345|NCT03565315|BG002|Baseline|Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11336346|NCT03565315|BG003|Baseline|Group 4: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11336347|NCT03565315|BG004|Baseline|Total|Total of all reporting groups
11336348|NCT03565315|FG000|Participant Flow|Group 1: 10E8VLS (5 mg/kg) SC Single Dose Group|"10E8VLS (5 mg/kg) administered by the subcutaneous (SC) route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
11332565|NCT03497585|FG000|Participant Flow|Activity Pacing Framework|"Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.~Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies."
11332566|NCT03497585|OG000|Outcome|Activity Pacing Framework|"Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.~Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies."
11332567|NCT03497585|EG000|Reported Event|Activity Pacing Framework|"Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.~Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies."
11332568|NCT03497845|BG000|Baseline|a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332569|NCT03497845|BG001|Baseline|b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332570|NCT03497845|BG002|Baseline|c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332571|NCT03497845|BG003|Baseline|d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332572|NCT03497845|BG004|Baseline|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332573|NCT03497845|BG005|Baseline|f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332574|NCT03497845|BG006|Baseline|g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332575|NCT03497845|BG007|Baseline|h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332576|NCT03497845|BG008|Baseline|i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332577|NCT03497845|BG009|Baseline|j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11292689|NCT02954575|FG000|Participant Flow|Wilate|"A total of 57 patients were enrolled in the study. For the PK assessment (PK population) a single dose of Wilate of 50 ±5 IU/kg BW was administered to 21 patients.~For prophylactic treatment, Wilate was administered every 2 to 3 days at a dose of 20-40 IU/kg BW for 6 months. In case of unacceptably frequent spontaneous breakthrough BEs, the dose of Wilate was increased by approximately 5 IU/kg.~The dose (and duration) of treatment for BEs was dependent on the location and extent of bleeding and on the clinical condition of the patient; range: 10-50 IU/kg every 12-24 hours or 8-24 hours until resolved.~For the surgical prophylaxis population (SURG population), minor surgeries were treated with 15-30 IU/kg every 24 hours, at least 1 day, until healing iwas achieved. Major surgeries were treated with 40-50 IU/kg, repeat injection every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a FVIII activity of 30% to 60%."
11292690|NCT02954575|OG000|Outcome|Wilate|PP population
11292691|NCT02954575|OG000|Outcome|Wilate|Efficacy of Wilate was analysed for the PP population
11292692|NCT02954575|OG000|Outcome|Wilate|PK population
11292693|NCT02954575|OG000|Outcome|Wilate|FAS population
11292694|NCT02954575|OG000|Outcome|Wilate|SURG population (study population of patients undergoing surgery treated with Wilate)
11292695|NCT02954575|EG000|Reported Event|Wilate|SAF population
11292696|NCT02954601|BG000|Baseline|Placebo|Placebo (fish oil)
11292697|NCT02954601|BG001|Baseline|ORMD-0801 qd|Oral Insulin once per day
11292698|NCT02954601|BG002|Baseline|ORMD-0801 Bid|Oral Insulin twice per day
11292699|NCT02954601|BG003|Baseline|ORMD-0801 Tid|Oral Insulin three times per day
11292700|NCT02954601|BG004|Baseline|Total|Total of all reporting groups
11292701|NCT02954601|FG000|Participant Flow|Placebo|Placebo (fish oil) Placebo: fish oil placebo
11292702|NCT02954601|FG001|Participant Flow|Dose1|Dose 1 = ORMD-0801 qid
11292703|NCT02954601|FG002|Participant Flow|Dose2|Dose 2 = ORMD-0801 bid
11292704|NCT02954601|FG003|Participant Flow|Dose 3|Dose 3 = ORMD-0801 tid
11292705|NCT02954601|OG000|Outcome|Placebo|Fish Oil placebo
11292706|NCT02954601|OG001|Outcome|Dose 1|ORMD-0801 qid
11292707|NCT02954601|OG002|Outcome|Dose 2|ORMD-0801 bid
11292708|NCT02954601|OG003|Outcome|Dose 3|ORMD-0801 tid
11292709|NCT02954601|EG000|Reported Event|Placebo|Placebo (fish oil) Placebo: fish oil placebo
11292710|NCT02954601|EG001|Reported Event|Dose 1|Dose 1 = ORMD-0801 qid
11292711|NCT02954601|EG002|Reported Event|Dose 2|Dose 2 = ORMD-0801 bid
10822215|NCT00075335|FG000|Participant Flow|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers. AMD 3100 volunteer response to peripheral blood stem cell mobilization
11292712|NCT02954601|EG003|Reported Event|Dose 3|Dose 3 = ORMD-0801 tid
11292713|NCT02954653|BG000|Baseline|Part 1: PF-06747143 0.3 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.
11292714|NCT02954653|BG001|Baseline|Part 1: PF-06747143 1 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
11292715|NCT02954653|BG002|Baseline|Total|Total of all reporting groups
11292716|NCT02954653|FG000|Participant Flow|Part 1: PF-06747143 0.3 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.
11292717|NCT02954653|FG001|Participant Flow|Part 1: PF-06747143 1 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
11292718|NCT02954653|FG002|Participant Flow|Part 1: PF-06747143 at 3 mg/kg|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 3 mg/kg in 28-day cycles.
11292719|NCT02954653|FG003|Participant Flow|Part 1: PF-06747143 at 10 mg/kg|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles.
11292720|NCT02954653|FG004|Participant Flow|Part 1: PF-06747143 at 15 mg/kg|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 15 mg/kg in 28-day cycles.
11292721|NCT02954653|FG005|Participant Flow|Part 1: PF-06747143 at 20 mg/kg|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 20 mg/kg in 28-day cycles.
11292722|NCT02954653|FG006|Participant Flow|Part 2: PF-06747143 at MTD/RP2D|This arm was not initiated due to early termination of the study. PF-06747143 at Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) as an intravenous infusion once weekly in 28-day cycles was optional for Part 2 and planned to be initiated in Part 2 based on single agent PF-06747143 clinical benefit in Part 1.
11292723|NCT02954653|FG007|Participant Flow|Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.
11292724|NCT02954653|FG008|Participant Flow|Part 2: PF-06747143 Combined With Azacitidine or Decitabine|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
11292725|NCT02954653|OG000|Outcome|Part 1: PF-06747143 0.3 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.
11292726|NCT02954653|OG001|Outcome|Part 1: PF-06747143 1 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
11292727|NCT02954653|OG000|Outcome|Part 2: PF-06747143 at MTD/RP2D|This arm was not initiated due to early termination of the study. PF-06747143 at Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) as an intravenous infusion once weekly in 28-day cycles was optional for Part 2 and planned to be initiated in Part 2 based on single agent PF-06747143 clinical benefit in Part 1.
11216386|NCT02306265|BG000|Baseline|Mammography FFDM and DBT|"All subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Order for scan method was not assigned.~Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device~Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device"
11216387|NCT02306265|FG000|Participant Flow|Mammography FFDM and DBT|"All subjects were expected to undergo 2D breast imaging with full-field digital mammography (FFDM) and 3D breast imaging with digital breast tomosynthesis (DBT). The order in which these scans took place was not assigned.~Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device~Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device"
11216388|NCT02306265|OG000|Outcome|Mammography FFDM and DBT|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device~Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device"
11216389|NCT02306265|OG000|Outcome|Mammography FFDM and DBT|"All subjects underwent 2D breast imaging with full-field digital mammography (FFDM) and 3D breast imaging with digital breast tomosynthesis (DBT). The order in which these scans took place was not assigned.~Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device~Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device"
11216390|NCT02306265|EG000|Reported Event|Mammography FFDM and DBT|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).~Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device~Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device"
11216391|NCT02306694|BG000|Baseline|Open Label|"Everyone receives Advate (antihemophilic factor) on Day 1 and 3.~Advate: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study."
11216392|NCT02306694|FG000|Participant Flow|Open Label|"Everyone receives Advate (antihemophilic factor) on Day 1 and 3.~Advate: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study."
11216393|NCT02306694|OG000|Outcome|Open Label|"Everyone receives Advate (antihemophilic factor) on Day 1 and 3.~Advate: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study."
11216394|NCT02306694|EG000|Reported Event|Open Label|"Everyone receives Advate (antihemophilic factor) on Day 1 and 3.~Advate: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study."
11216395|NCT02306759|BG000|Baseline|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
11216396|NCT02306759|BG001|Baseline|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
11216397|NCT02306759|BG002|Baseline|Total|Total of all reporting groups
11216398|NCT02306759|FG000|Participant Flow|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
11216399|NCT02306759|FG001|Participant Flow|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
11216400|NCT02306759|OG000|Outcome|Treatment|"Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes~Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
11216401|NCT02306759|OG001|Outcome|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
11216402|NCT02306759|OG000|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
11216403|NCT02306759|OG001|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
11216404|NCT02306759|EG000|Reported Event|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
11216405|NCT02306759|EG001|Reported Event|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
11216406|NCT02306850|BG000|Baseline|Pembrolizumab|"Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).~Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment."
11216407|NCT02306850|FG000|Participant Flow|Pembrolizumab|"Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).~Assess the efficacy of neoadjuvant pembrolizumab in improving resectability rates in subjects with unresectable Stage III or unresectable Stage IV melanoma. Patients are eligible for study entry if complete metastectomy would be possible if the burden of disease can be decreased in size by up to 50%.~Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment."
11216408|NCT02306850|OG000|Outcome|Pembrolizumab|"Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).~Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment."
11216409|NCT02306850|OG000|Outcome|Pembrolizumab|"Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).~Pembrolizumab: At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment."
11292728|NCT02954653|OG001|Outcome|Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.
11292729|NCT02954653|OG002|Outcome|Part 2: PF-06747143 Combined With Azacitidine or Decitabine|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
11292730|NCT02954653|OG002|Outcome|Part 2: PF-06747143 at MTD/RP2D|This arm was not initiated due to early termination of the study. PF-06747143 at Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) as an intravenous infusion once weekly in 28-day cycles was optional for Part 2 and planned to be initiated in Part 2 based on single agent PF-06747143 clinical benefit in Part 1.
11292731|NCT02954653|OG003|Outcome|Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.
11292732|NCT02954653|OG004|Outcome|Part 2: PF-06747143 Combined With Azacitidine or Decitabine|This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
11292733|NCT02954653|EG000|Reported Event|Part 1: PF-06747143 0.3 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.
11292734|NCT02954653|EG001|Reported Event|Part 1: PF-06747143 1 mg/kg|PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
11292735|NCT02954848|BG000|Baseline|Placebo|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 placebo-matching tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292736|NCT02954848|BG001|Baseline|TAK-438 10 mg|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 10 mg tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292737|NCT02954848|BG002|Baseline|Total|Total of all reporting groups
11292738|NCT02954848|FG000|Participant Flow|Placebo|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 placebo-matching tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292739|NCT02954848|FG001|Participant Flow|TAK-438 10 mg|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 10 mg tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292740|NCT02954848|OG000|Outcome|Placebo|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 placebo-matching tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292741|NCT02954848|OG001|Outcome|TAK-438 10 mg|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 10 mg tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292742|NCT02954848|EG000|Reported Event|Placebo|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 placebo-matching tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292743|NCT02954848|EG001|Reported Event|TAK-438 10 mg|TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 10 mg tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.
11292744|NCT02954887|BG000|Baseline|GWP42003-P OS|Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose.
11292745|NCT02954887|FG000|Participant Flow|GWP42003-P OS|Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose.
11292746|NCT02954887|OG000|Outcome|GWP42003-P OS|Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open-label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose.
11292747|NCT02954887|EG000|Reported Event|Cannabidiol OS|Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose.
11292748|NCT02955069|BG000|Baseline|Well-differentiated NET|Subjects with advanced or metastatic, well-differentiated non-functional NET of GI, pancreatic or thoracic origin that progressed on or after prior available treatments.
11292749|NCT02955069|BG001|Baseline|Poorly-differentiated GEP-NEC|Subjects with advanced or metastatic poorly-differentiated GEP-NEC that progressed on or after prior available treatments.
11292750|NCT02955069|BG002|Baseline|Total|Total of all reporting groups
11292751|NCT02955069|FG000|Participant Flow|Well-differentiated NET|Subjects with advanced or metastatic, well-differentiated non-functional NET of GI, pancreatic or thoracic origin that progressed on or after prior available treatments.
11292752|NCT02955069|FG001|Participant Flow|Poorly-differentiated GEP-NEC|Subjects with advanced or metastatic poorly-differentiated GEP-NEC that progressed on or after prior available treatments.
11292753|NCT02955069|OG000|Outcome|Well-differentiated NET|Subjects with advanced or metastatic, well-differentiated non-functional NET of GI, pancreatic or thoracic origin that progressed on or after prior available treatments.
11292754|NCT02955069|OG001|Outcome|Poorly-differentiated GEP-NEC|Subjects with advanced or metastatic poorly-differentiated GEP-NEC that progressed on or after prior available treatments.
11292755|NCT02955069|OG001|Outcome|Poorly Differentiated GEP-NEC|Subjects with advanced or metastatic poorly-differentiated GEP-NEC that progressed on or after prior available treatments.
11292756|NCT02955069|EG000|Reported Event|Well-differentiated NET|Subjects with advanced or metastatic, well-differentiated non-functional NET of GI, pancreatic or thoracic origin that progressed on or after prior available treatments.
11292757|NCT02955069|EG001|Reported Event|Poorly-differentiated GEP-NEC|Subjects with advanced or metastatic poorly-differentiated GEP-NEC that progressed on or after prior available treatments
11292758|NCT02955069|EG002|Reported Event|All Subjects|All subjects
11292759|NCT02955147|BG000|Baseline|Ustekinumab Plus Prednisone|"Ustekinumab: 90 mg of ustekinumab will be administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.~Prednisone: All patients will receive a prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone will be chosen by the investigators according to disease severity and comorbid medical conditions. The duration of the prednisone taper will be 6 months in all cases.~Ustekinumab: Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling~Prednisone: Prednisone is an anti-inflammatory medication"
11292760|NCT02955147|FG000|Participant Flow|Ustekinumab Plus Prednisone|"Ustekinumab 90 mg was administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.~Ustekinumab: Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling~All patients received a 6 month prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone was chosen by the investigators according to disease severity and comorbid medical conditions. The initial prednisone dose was 60 mg in 3 patients, 40 mg in 9 patients, and 20 mg in 1 patient.~Prednisone is an anti-inflammatory medication"
11292761|NCT02955147|OG000|Outcome|Ustekinumab Plus Prednisone|"Ustekinumab 90 mg was administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.~All patients received a 6 month prednisone course tapered according to predefined schedules starting at either 60 mg (n = 3), 40 mg (n = 9) or 20 mg (n = 1)."
11292762|NCT02955147|EG000|Reported Event|Ustekinumab Plus Prednisone|"Ustekinumab 90 mg was administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.~Ustekinumab: Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling~All patients received a 6 month prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone was chosen by the investigators according to disease severity and comorbid medical conditions. The initial prednisone dose was 60 mg in 3 patients, 40 mg in 9 patients, and 20 mg in 1 patient.~Prednisone is an anti-inflammatory medication"
11292763|NCT02955186|BG000|Baseline|125 mg Saracatinib|"Participants will take 125 mg of saracatinib daily for 8 days.~Saracatinib: Saracatinib 125 mg once per day for 8 days"
11292764|NCT02955186|BG001|Baseline|Placebo|"Participants will take placebo daily for 8 days.~Placebos: Placebo once per day for 8 days"
11292765|NCT02955186|BG002|Baseline|Total|Total of all reporting groups
11292766|NCT02955186|FG000|Participant Flow|125 mg Saracatinib|"Participants will take 125 mg of saracatinib daily for 8 days.~Saracatinib: Saracatinib 125 mg once per day for 8 days"
11292767|NCT02955186|FG001|Participant Flow|Placebo|"Participants will take placebo daily for 8 days.~Placebos: Placebo once per day for 8 days"
11292768|NCT02955186|OG000|Outcome|125 mg Saracatinib|"Participants will take 125 mg of saracatinib daily for 8 days.~Saracatinib: Saracatinib 125 mg once per day for 8 days"
11292769|NCT02955186|OG001|Outcome|Placebo|"Participants will take placebo daily for 8 days.~Placebos: Placebo once per day for 8 days"
11292770|NCT02955186|EG000|Reported Event|125 mg Saracatinib|"Participants will take 125 mg of saracatinib daily for 8 days.~Saracatinib: Saracatinib 125 mg once per day for 8 days"
11292771|NCT02955186|EG001|Reported Event|Placebo|"Participants will take placebo daily for 8 days.~Placebos: Placebo once per day for 8 days"
11292772|NCT02955212|BG000|Baseline|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
11292773|NCT02955212|BG001|Baseline|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
11292774|NCT02955212|BG002|Baseline|Total|Total of all reporting groups
11292775|NCT02955212|FG000|Participant Flow|Placebo / Upadacitinib 15 mg|Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
11292776|NCT02955212|FG001|Participant Flow|Upadacitinib 15 mg / Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
11292777|NCT02955212|OG000|Outcome|Placebo|Participants randomized to receive placebo once daily for 12 weeks in Period 1.
11292778|NCT02955212|OG001|Outcome|Upadacitinib 15 mg|Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
11292779|NCT02955212|EG000|Reported Event|Period 1: Placebo|Participants received placebo once daily for 12 weeks in Period 1.
11292780|NCT02955212|EG001|Reported Event|Period 1: Upadacitinib 15 mg|Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1.
11292781|NCT02955212|EG002|Reported Event|Period 1+2: Upadacitinib 15 mg|Participants originally assigned to placebo received upadacitinib 15 mg from Week 12 to Week 64. Participants originally assigned to upadacitinib received upadacitinib 15 mg from Week 0 to Week 64.
11292782|NCT02955329|BG000|Baseline|All Participants|All participants were enrolled and received each of the interventions in a different order. Each intervention lasted 1 day.
11292783|NCT02955329|FG000|Participant Flow|All Participants|All participants were enrolled and received each of the interventions in a different order. Each intervention lasted 1 day.
10971005|NCT00913458|OG001|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
10971006|NCT00913458|OG002|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
10971007|NCT00913458|OG000|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
10971008|NCT00913458|OG001|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
11292784|NCT02955329|OG000|Outcome|Tobacco Arm|"Participants will vape tobacco leaves with nicotine out of the PAX device.~Nicotine: Participants will vape tobacco leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11292785|NCT02955329|OG001|Outcome|Cannabis Arm|"Participants will vape marijuana leaves with THC (Tetrahydrocannabinol) out of the PAX device.~Cannabis: Participants will vape marijuana leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11292786|NCT02955329|OG002|Outcome|Combined Cannabis and Tobacco Arm|"Participants will vape flavorless 6% nicotine e-liquid, followed by THC (Tetrahydrocannabinol) out of the PAX device.~Nicotine: Participants will vape tobacco leaves with nicotine out of the PAX device.~Cannabis: Participants will vape marijuana leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11292787|NCT02955329|EG000|Reported Event|Tobacco Arm|"Participants will vape tobacco leaves with nicotine out of the PAX device.~Nicotine: Participants will vape tobacco leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11292788|NCT02955329|EG001|Reported Event|Cannabis Arm|"Participants will vape marijuana leaves with THC (Tetrahydrocannabinol) out of the PAX device.~Cannabis: Participants will vape marijuana leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11332578|NCT03497845|BG010|Baseline|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10822216|NCT00075335|OG000|Outcome|AMD 3100 Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
11292789|NCT02955329|EG002|Reported Event|Combined Cannabis and Tobacco Arm|"Participants will vape flavorless 6% nicotine e-liquid, followed by THC (Tetrahydrocannabinol) out of the PAX device.~Nicotine: Participants will vape tobacco leaves with nicotine out of the PAX device.~Cannabis: Participants will vape marijuana leaves with nicotine out of the PAX device.~PAX Loose Leaf Vaporizer: In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC."
11292790|NCT02956044|BG000|Baseline|Group 1: Bexagliflozin + Metformin|Bexagliflozin tablets 20 mg alone, Metformin tablets 1000 mg alone, or Bexagliflozin 20 mg + Metformin 1000 mg
11292791|NCT02956044|BG001|Baseline|Group 2: Bexagliflozin + Glimepiride|Bexagliflozin tablets 20 mg alone, Glimepiride tablets 2 mg alone, or Bexagliflozin 20 mg + Glimepiride 2 mg
11292792|NCT02956044|BG002|Baseline|Group 3: Bexagliflozin + Sitagliptin|Bexagliflozin tablets 20 mg alone, Sitagliptin 100 mg alone, or Bexagliflozin 20 mg + Sitagliptin 100 mg
11292793|NCT02956044|BG003|Baseline|Total|Total of all reporting groups
11292794|NCT02956044|FG000|Participant Flow|Group 1: Bexagliflozin + Metformin|Bexagliflozin tablets 20 mg alone, Metformin tablets 1000 mg alone, or Bexagliflozin 20 mg + Metformin 1000 mg
11292795|NCT02956044|FG001|Participant Flow|Group 2: Bexagliflozin + Glimepiride|Bexagliflozin tablets 20 mg alone, Glimepiride tablets 2 mg alone, or Bexagliflozin 20 mg + Glimepiride 2 mg
11292796|NCT02956044|FG002|Participant Flow|Group 3: Bexagliflozin + Sitagliptin|Bexagliflozin tablets 20 mg alone, Sitagliptin 100 mg alone, or Bexagliflozin 20 mg + Sitagliptin 100 mg
11292797|NCT02956044|OG000|Outcome|Group 1: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
11292798|NCT02956044|OG001|Outcome|Group 1: Metformin Alone|Metformin: Metformin tablets, 1000 mg
11292799|NCT02956044|OG002|Outcome|Group 1: Bexagliflozin + Metformin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Metformin: Metformin tablets, 1000 mg"
11292800|NCT02956044|OG003|Outcome|Group 2: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
11292801|NCT02956044|OG004|Outcome|Group 2: Glimepiride Alone|Glimepiride: Glimepiride tablets, 2 mg
11292802|NCT02956044|OG005|Outcome|Group 2: Bexagliflozin + Glimepiride|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Glimepiride: Glimepiride tablets, 2 mg"
11292803|NCT02956044|OG006|Outcome|Group 3: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
11292804|NCT02956044|OG007|Outcome|Group 3: Sitagliptin Alone|Sitagliptin: Sitagliptin tablets, 100 mg
11292805|NCT02956044|OG008|Outcome|Group 3: Bexagliflozin + Sitagliptin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Sitagliptin: Sitagliptin tablets, 100 mg"
11292806|NCT02956044|OG004|Outcome|Group 2: Glimepiride Alone|Glimepiride: Glimepiride tablets, 4 mg
11292807|NCT02956044|OG005|Outcome|Group 2: Bexagliflozin + Glimepiride|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Glimepiride: Glimepiride tablets, 4 mg"
11292808|NCT02956044|EG000|Reported Event|Group 1: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
11292809|NCT02956044|EG001|Reported Event|Group 1: Metformin Alone|Metformin: Metformin tablets, 1000 mg
11292810|NCT02956044|EG002|Reported Event|Group 1: Bexagliflozin + Metformin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Metformin: Metformin tablets, 1000 mg"
11292811|NCT02956044|EG003|Reported Event|Group 2: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
11292812|NCT02956044|EG004|Reported Event|Group 2: Glimepiride Alone|Glimepiride: Glimepiride tablets, 2 mg
11292813|NCT02956044|EG005|Reported Event|Group 2: Bexagliflozin + Glimepiride|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Glimepiride: Glimepiride tablets, 2 mg"
11292814|NCT02956044|EG006|Reported Event|Group 3: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg
10822217|NCT00075335|EG000|Reported Event|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
11292815|NCT02956044|EG007|Reported Event|Group 3: Sitagliptin Alone|Sitagliptin: Sitagliptin tablets, 100 mg
11292816|NCT02956044|EG008|Reported Event|Group 3: Bexagliflozin + Sitagliptin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Sitagliptin: Sitagliptin tablets, 100 mg"
11292817|NCT02956057|BG000|Baseline|PEG1D|Polyethylene glycols single dose a day before colonoscopy
11292818|NCT02956057|BG001|Baseline|PEG2D|Polyethylene glycols split dose
11292819|NCT02956057|BG002|Baseline|SPMC1D|Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
11292820|NCT02956057|BG003|Baseline|SPMC2D|Natrium picosulfate/ Magnesium citrate split dose
11292821|NCT02956057|BG004|Baseline|PEGA1D|Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
11292822|NCT02956057|BG005|Baseline|PEGA2D|Polyethylene glycol / Ascorbic acid split dose
11292823|NCT02956057|BG006|Baseline|Total|Total of all reporting groups
11292824|NCT02956057|FG000|Participant Flow|PEG1D|"Polyethylene glycols single dose a day before colonoscopy~Polyethylene Glycols"
11292825|NCT02956057|FG001|Participant Flow|PEG2D|"Polyethylene glycols split dose~Polyethylene Glycols"
11292826|NCT02956057|FG002|Participant Flow|SPMC1D|"Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy~Natrium picosulfate / Magnesium citrate"
11292827|NCT02956057|FG003|Participant Flow|SPMC2D|"Natrium picosulfate/ Magnesium citrate split dose~Natrium picosulfate / Magnesium citrate"
11292828|NCT02956057|FG004|Participant Flow|PEGA1D|"Polyethylene glycol / Ascorbic acid single dose day before colonoscopy~Polyethylene glycol / Ascorbic acid"
11292829|NCT02956057|FG005|Participant Flow|PEGA2D|"Polyethylene glycol / Ascorbic acid split dose~Polyethylene glycol / Ascorbic acid"
11292830|NCT02956057|OG000|Outcome|PEG1D|Polyethylene glycols single dose a day before colonoscopy
11292831|NCT02956057|OG001|Outcome|PEG2D|Polyethylene glycols split dose
11292832|NCT02956057|OG002|Outcome|SPMC1D|Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
11292833|NCT02956057|OG003|Outcome|SPMC2D|Natrium picosulfate/ Magnesium citrate split dose
11292834|NCT02956057|OG004|Outcome|PEGA1D|Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
11292835|NCT02956057|OG005|Outcome|PEGA2D|Polyethylene glycol / Ascorbic acid split dose
11292836|NCT02956057|EG000|Reported Event|PEG1D|Polyethylene glycols single dose a day before colonoscopy
11292837|NCT02956057|EG001|Reported Event|PEG2D|Polyethylene glycols split dose
11292838|NCT02956057|EG002|Reported Event|SPMC1D|Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
11292839|NCT02956057|EG003|Reported Event|SPMC2D|Natrium picosulfate/ Magnesium citrate split dose
11292840|NCT02956057|EG004|Reported Event|PEGA1D|Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
11292841|NCT02956057|EG005|Reported Event|PEGA2D|Polyethylene glycol / Ascorbic acid split dose
11292842|NCT02956070|BG000|Baseline|Experimental|"35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.~Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292843|NCT02956070|BG001|Baseline|Placebo|"35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention~Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292844|NCT02956070|BG002|Baseline|Total|Total of all reporting groups
11292845|NCT02956070|FG000|Participant Flow|Experimental|"35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.~Dexamethasone acetate: The volunteers in the Dexamethasone acetate group (experimental group) received six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied w"
11292846|NCT02956070|FG001|Participant Flow|Placebo|"35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention~Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292847|NCT02956070|OG000|Outcome|Experimental|"35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.~Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292848|NCT02956070|OG001|Outcome|Placebo|"35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention~Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292849|NCT02956070|EG000|Reported Event|Experimental|"35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.~Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292850|NCT02956070|EG001|Reported Event|Placebo|"35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention~Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes ."
11292851|NCT02956122|BG000|Baseline|GLASSIA|Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
11292852|NCT02956122|FG000|Participant Flow|GLASSIA|Participants received an intravenous (IV) infusion of GLASSIA at a dose of 90 milligrams per kilogram (mg/kg) on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 milligrams per kilogram per day (mg/kg/day) of methylprednisolone or equivalent steroid.
11292853|NCT02956122|OG000|Outcome|GLASSIA|Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
11292854|NCT02956122|OG000|Outcome|GLASSIA: Day 1: 90 mg/kg|Participants received an IV infusion of 90 mg/kg GLASSIA.
11292855|NCT02956122|OG001|Outcome|GLASSIA: Day 13: 30 mg/kg|Participants received an IV infusion of 30 mg/kg GLASSIA.
11292856|NCT02956122|OG002|Outcome|GLASSIA: Day 22: 120 mg/kg|Participants received an IV infusion of 120 mg/kg GLASSIA.
11292857|NCT02956122|OG003|Outcome|GLASSIA: Day 50: 120 mg/kg|Participants received an IV infusion of 120 mg/kg GLASSIA.
11292858|NCT02956122|OG000|Outcome|GLASSIA: Day 13: 30 mg/kg|Participants received an IV infusion of 30 mg/kg GLASSIA.
11292859|NCT02956122|OG001|Outcome|GLASSIA: Day 22: 120 mg/kg|Participants received an IV infusion of 120 mg/kg GLASSIA.
11292860|NCT02956122|OG002|Outcome|GLASSIA: Day 50: 120 mg/kg|Participants received an IV infusion of 120 mg/kg GLASSIA.
11292861|NCT02956122|EG000|Reported Event|GLASSIA|Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
11292862|NCT02956278|BG000|Baseline|BCRP Q141K CC Genotype|All subjects that completed the protocol with the reference BCRP Q141K genotype (CC alleles)
11292863|NCT02956278|BG001|Baseline|BCRP Q141K CA Genotype|All subjects that completed the protocol with the heterozygous BCRP Q141K genotype (CA alleles)
11292864|NCT02956278|BG002|Baseline|BCRP Q141K AA Genotype|All subjects that completed the protocol with the homozygous BCRP Q141K genotype (AA alleles)
11292865|NCT02956278|BG003|Baseline|Total|Total of all reporting groups
11292866|NCT02956278|FG000|Participant Flow|BCRP Q141K CC|Participants that are homozygous reference for BCRP Q141K receive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours.
11292867|NCT02956278|FG001|Participant Flow|BCRP Q141K CA|Participants that are heterozygous for the BCRP Q141K allele receive one 300 mg dose of allopurinol, with blood/urine collections up to 72 hours.
11292868|NCT02956278|FG002|Participant Flow|BCRP Q141K AA|Participants homozygous for the BCRP Q141K allele receive one 300 mg dose of allopurinol with blood/urine collection for up to 72 hours.
11292869|NCT02956278|OG000|Outcome|BCRP Q141K CC Genotype|All subjects that completed the protocol with the reference BCRP Q141K genotype (CC alleles)
11292870|NCT02956278|OG001|Outcome|BCRP Q141K CA Genotype|All subjects that completed the protocol with the heterozygous BCRP Q141K genotype (CA alleles)
11292871|NCT02956278|OG002|Outcome|BCRP Q141K AA Genotype|All subjects that completed the protocol with the homozygous BCRP Q141K genotype (AA alleles)
11292872|NCT02956278|EG000|Reported Event|BCRP Q141K CC|Participants homozygous reference for BCRP Q141K receive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours.
11292873|NCT02956278|EG001|Reported Event|BCRP Q141K CA|Participants heterozygous for BCRP Q141Kr eceive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours.
11292874|NCT02956278|EG002|Reported Event|BCRP Q141K AA|Participants homozygous for BCRP Q141Kr eceive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours.
10971009|NCT00913458|OG002|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
10971010|NCT00913458|OG001|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
10971011|NCT00913458|OG002|Outcome|Placebo (PBO) (Phase 2)|In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
10971012|NCT00913458|EG000|Reported Event|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
10971013|NCT00913458|EG001|Reported Event|E25 + MTX (Phase 2)|"In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
11216410|NCT02306850|EG000|Reported Event|Pembrolizumab|"Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).~Pembrolizumab: At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment."
11216411|NCT02306928|BG000|Baseline|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11216412|NCT02306928|FG000|Participant Flow|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11216413|NCT02306928|OG000|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11216414|NCT02306928|EG000|Reported Event|Piperacillin Pharmacokinetics|Serious and non-serious adverse advents were not collected.
11216415|NCT02307123|BG000|Baseline|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11216416|NCT02307123|FG000|Participant Flow|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11292875|NCT02956460|BG000|Baseline|Fanfilcon A First Then Senofilcon A|Participants are randomized to wear fanfilcon A for two weeks then senofilcon A
11292876|NCT02956460|BG001|Baseline|Senofilcon A First Then Fanfilcon A|Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
11292877|NCT02956460|BG002|Baseline|Total|Total of all reporting groups
11292878|NCT02956460|FG000|Participant Flow|Fanfilcon A First Then Senofilcon A|Participants are randomized to wear fanfilcon A for two weeks then senofilcon A
11292879|NCT02956460|FG001|Participant Flow|Senofilcon A First Then Fanfilcon A|Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
11292880|NCT02956460|OG000|Outcome|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
11292881|NCT02956460|OG001|Outcome|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
11292882|NCT02956460|EG000|Reported Event|Fanfilcon A|Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study
11292883|NCT02956460|EG001|Reported Event|Senofilcon A|Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study
11292884|NCT02956486|BG000|Baseline|Core Phase: Placebo|Participants received one elenbecestat matching-placebo tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat matched placebo in core phase.
11292885|NCT02956486|BG001|Baseline|Core Phase: Elenbecestat 50 mg|Participants received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat in core phase.
11292886|NCT02956486|BG002|Baseline|Total|Total of all reporting groups
11292887|NCT02956486|FG000|Participant Flow|Core Phase: Placebo|Participants received one elenbecestat matching-placebo tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat matched placebo in core phase.
11292888|NCT02956486|FG001|Participant Flow|Core Phase: Elenbecestat 50 mg|Participants received one elenbecestat 50 milligram (mg) tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat in core phase.
11292889|NCT02956486|FG002|Participant Flow|Extension Phase: Elenbecestat 50 mg|Eligible participants who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food until commercial availability of elenbecestat, or a lack of positive benefit-risk assessment was determined, whichever occurred first. Participants were followed up for 1 month after the last dose of elenbecestat in the extension phase.
11292890|NCT02956486|OG000|Outcome|Core Phase: Placebo|Participants received one elenbecestat matching-placebo tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat matched placebo in core phase.
11292891|NCT02956486|OG001|Outcome|Core Phase: Elenbecestat 50 mg|Participants received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat in core phase.
11292892|NCT02956486|OG000|Outcome|Extension Phase: Elenbecestat 50 mg|In the extension phase, participants received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food until commercial availability of elenbecestat, or a lack of positive benefit-risk assessment was determined, whichever occurred first. Participants were followed up for 1 month after the last dose of elenbecestat in the extension phase.
11292893|NCT02956486|OG000|Outcome|Core Phase: Placebo|Participants received one elenbecestat matching-placebo tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat matched placebo in core phase
11292894|NCT02956486|EG000|Reported Event|Core Phase: Placebo|Participants received one elenbecestat matching-placebo tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat matched placebo in core phase.
11292895|NCT02956486|EG001|Reported Event|Core Phase: Elenbecestat 50 mg|Participants received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food up to 24 months. Participants were followed up for 3 months after last dose of elenbecestat in core phase.
11292896|NCT02956486|EG002|Reported Event|Extension Phase: Elenbecestat 50 mg|Eligible participants who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily in the morning with or without food until commercial availability of elenbecestat, or a lack of positive benefit-risk assessment was determined, whichever occurred first. Participants were followed up for 1 month after last dose of elenbecestat in extension phase.
11292897|NCT02956616|BG000|Baseline|Enhanced Recovery|Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.
11292898|NCT02956616|BG001|Baseline|Routine Perioperative Care|Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control.
11292899|NCT02956616|BG002|Baseline|Total|Total of all reporting groups
11292900|NCT02956616|FG000|Participant Flow|Enhanced Recovery|"Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.~ketorolac: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.~Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for"
11292901|NCT02956616|FG001|Participant Flow|Routine Perioperative Care|"Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control~ketorolac: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins."
11292902|NCT02956616|OG000|Outcome|Enhanced Recovery|"Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.~ketorolac: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.~Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for"
11292903|NCT02956616|OG001|Outcome|Routine Perioperative Care|"Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control~ketorolac: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins."
11292904|NCT02956616|EG000|Reported Event|Enhanced Recovery|Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.
11292905|NCT02956616|EG001|Reported Event|Routine Perioperative Care|Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
11292906|NCT02956629|BG000|Baseline|HCV GT1|Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292907|NCT02956629|BG001|Baseline|HCV GT2|Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292908|NCT02956629|BG002|Baseline|HCV GT3|Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292909|NCT02956629|BG003|Baseline|HCV GT4|Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292910|NCT02956629|BG004|Baseline|HCV GT5|Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292911|NCT02956629|BG005|Baseline|HCV GT6|Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292912|NCT02956629|BG006|Baseline|Total|Total of all reporting groups
11292913|NCT02956629|FG000|Participant Flow|HCV Genotype (GT) 1|Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.
11292914|NCT02956629|FG001|Participant Flow|HCV GT2|Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292915|NCT02956629|FG002|Participant Flow|HCV GT3|Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292916|NCT02956629|FG003|Participant Flow|HCV GT4|Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292917|NCT02956629|FG004|Participant Flow|HCV GT5|Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292918|NCT02956629|FG005|Participant Flow|HCV GT6|Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292919|NCT02956629|OG000|Outcome|HCV GT1|Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292920|NCT02956629|OG001|Outcome|HCV GT2|Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292921|NCT02956629|OG002|Outcome|HCV GT3|Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292922|NCT02956629|OG003|Outcome|HCV GT4|Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292923|NCT02956629|OG004|Outcome|HCV GT5|Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292924|NCT02956629|OG005|Outcome|HCV GT6|Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292925|NCT02956629|EG000|Reported Event|HCV GT1|Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292926|NCT02956629|EG001|Reported Event|HCV GT2|Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292927|NCT02956629|EG002|Reported Event|HCV GT3|Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292928|NCT02956629|EG003|Reported Event|HCV GT4|Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292929|NCT02956629|EG004|Reported Event|HCV GT5|Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292930|NCT02956629|EG005|Reported Event|HCV GT6|Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
11292931|NCT02956746|BG000|Baseline|Imovax, SYN023|"Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292932|NCT02956746|BG001|Baseline|Imovax, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292933|NCT02956746|BG002|Baseline|RabAvert, SYN023|"Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292934|NCT02956746|BG003|Baseline|RabAvert, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292935|NCT02956746|BG004|Baseline|Total|Total of all reporting groups
11292936|NCT02956746|FG000|Participant Flow|Imovax, SYN023|"Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292937|NCT02956746|FG001|Participant Flow|Imovax, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292938|NCT02956746|FG002|Participant Flow|RabAvert, SYN023|"Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292939|NCT02956746|FG003|Participant Flow|RabAvert, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292940|NCT02956746|OG000|Outcome|Imovax, SYN023|"Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292941|NCT02956746|OG001|Outcome|Imovax, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292942|NCT02956746|OG002|Outcome|RabAvert, SYN023|"Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11332579|NCT03497845|BG011|Baseline|l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332580|NCT03497845|BG012|Baseline|Total|Total of all reporting groups
11216417|NCT02307123|OG000|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11216418|NCT02307123|EG000|Reported Event|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11216419|NCT02307266|BG000|Baseline|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11216420|NCT02307266|BG001|Baseline|Standard of Care|Subjects received standard-of-care instructions only.
11216421|NCT02307266|BG002|Baseline|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11216422|NCT02307266|BG003|Baseline|Total|Total of all reporting groups
11216423|NCT02307266|FG000|Participant Flow|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11216424|NCT02307266|FG001|Participant Flow|Standard of Care|Subjects received standard-of-care instructions only.
11216425|NCT02307266|FG002|Participant Flow|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11216426|NCT02307266|OG000|Outcome|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11216427|NCT02307266|OG001|Outcome|Standard of Care|Subjects received standard-of-care instructions only.
11216428|NCT02307266|OG002|Outcome|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11216429|NCT02307266|EG000|Reported Event|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11216430|NCT02307266|EG001|Reported Event|Standard of Care|Subjects received standard-of-care instructions only.
11216431|NCT02307266|EG002|Reported Event|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11216432|NCT02307318|BG000|Baseline|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11216433|NCT02307318|FG000|Participant Flow|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11216434|NCT02307318|OG000|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11216435|NCT02307318|EG000|Reported Event|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11216436|NCT02307370|BG000|Baseline|Turbo-Elite Atherectomy|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216437|NCT02307370|FG000|Participant Flow|Turbo-Elite Atherectomy|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216438|NCT02307370|OG000|Outcome|Turbo-Elite Atherectomy|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216439|NCT02307370|OG000|Outcome|Turbo-Elite Atherectomy (Screening)|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216440|NCT02307370|OG001|Outcome|Turbo-Elite Atherectomy (30-day Follow-up)|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216441|NCT02307370|EG000|Reported Event|Turbo-Elite Atherectomy|Turbo-Elite Laser Catheter: Application of laser energy to remove blockage
11216442|NCT02307513|BG000|Baseline|Placebo|Participants received identically appearing placebo tablets twice a day (BID) from weeks 0 to 12 during the placebo-controlled treatment phase. At week 12 participants were switched to apremilast 30 mg BID for 52 weeks during the active treatment phase and continued apremilast up to week 64.
11216443|NCT02307513|BG001|Baseline|Apremilast 30 mg BID|Participants received apremilast 30 mg tablets BID from weeks 0 to 12 during the placebo-controlled treatment phase and continued to receive apremilast 30 mg BID for 52 weeks during the active treatment phase up to week 64.
11216444|NCT02307513|BG002|Baseline|Total|Total of all reporting groups
11216445|NCT02307513|FG000|Participant Flow|Placebo/Apremilast|"Participants received identically appearing placebo tablets twice a day (BID) from weeks 0 to 12 during the placebo-controlled treatment phase. At week 12 participants were switched to apremilast 30 mg tablets BID for 52 weeks during the active treatment phase and continued apremilast up to week 64.~Participants in Germany had the option to continue receiving apremilast 30 mg BID in the extension phase."
11216446|NCT02307513|FG001|Participant Flow|Apremilast|"Participants received apremilast 30 mg tablets BID from weeks 0 to 12 during the placebo-controlled treatment phase and continued to receive apremilast 30 mg BID for 52 weeks during the active treatment phase up to week 64.~Participants in Germany had the option to continue receiving apremilast 30 mg BID in the extension phase."
11216447|NCT02307513|OG000|Outcome|Placebo|Participants received identically appearing placebo tablets twice a day from weeks 0 to 12 during the placebo-controlled treatment phase.
11216448|NCT02307513|OG001|Outcome|Apremilast 30 mg BID|Participants received apremilast 30 mg tablets BID from weeks 0 to 12 during the placebo-controlled treatment phase.
11216449|NCT02307513|OG000|Outcome|Placebo/Apremilast|Participants received identically appearing placebo tablets BID from weeks 0 to 12 during the placebo-controlled treatment phase and switched to apremilast 30 mg BID tablets at week 12 and continued up through week 64.
11216450|NCT02307513|OG001|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg tablets twice a day (BID) from weeks 0 to 12 during the placebo-controlled treatment phase and continued to receive apremilast 30 mg BID through week 64.
11216451|NCT02307513|EG000|Reported Event|Placebo-controlled Phase: Placebo|Participants received identically appearing placebo tablets twice a day from weeks 0 to 12 during the placebo-controlled treatment phase.
11216452|NCT02307513|EG001|Reported Event|Placebo-controlled Phase: Apremilast 30 mg BID|Participants received apremilast 30 mg tablets twice a day from weeks 0 to 12 during the placebo-controlled treatment phase.
11216453|NCT02307513|EG002|Reported Event|Apremilast Exposure Period: Apremilast 30 mg BID|Participants received apremilast 30 mg BID from week 0 or week 12 up to week 64.
11292943|NCT02956746|OG003|Outcome|RabAvert, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292944|NCT02956746|OG001|Outcome|RabAvert, SYN023|"Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292945|NCT02956746|EG000|Reported Event|Imovax, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11216454|NCT02307513|EG003|Reported Event|Open-label Extension Phase: Apremilast 30 mg BID|Participants in Germany received apremilast 30 mg BID in the open-label extension phase.
11216455|NCT02307526|BG000|Baseline|Spinal Cord Injury|Ten individuals with SCI (C4-C7) were recruited.
10822218|NCT00075400|BG000|Baseline|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
11216456|NCT02307526|FG000|Participant Flow|Spinal Cord Injury|10 individuals with spinal cord injury (SCI: C4-C7) were recruited.
11216457|NCT02307526|OG000|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
11216458|NCT02307526|OG001|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
11216459|NCT02307526|EG000|Reported Event|Day 1 - No Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
11216460|NCT02307526|EG001|Reported Event|Day 2 - Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide 60 mg will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
11216461|NCT02307552|BG000|Baseline|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
11216462|NCT02307552|FG000|Participant Flow|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
11216463|NCT02307552|OG000|Outcome|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
11292946|NCT02956746|EG001|Reported Event|RabAvert, Human Rabies Immune Globulin|"Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292947|NCT02956746|EG002|Reported Event|Imovax, SYN023|"Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292948|NCT02956746|EG003|Reported Event|RabAvert, SYN023|"Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine~SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.~Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine~RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine"
11292949|NCT02956837|BG000|Baseline|GSK3003891A Vaccine Formulation 1 Group|Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292950|NCT02956837|BG001|Baseline|GSK3003891A Vaccine Formulation 2 Group|Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292951|NCT02956837|BG002|Baseline|GSK3003891A Vaccine Formulation 3 Group|Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292952|NCT02956837|BG003|Baseline|Control Group|Subjects in this group received a single placebo injection at Day 0.
11292953|NCT02956837|BG004|Baseline|Total|Total of all reporting groups
11292954|NCT02956837|FG000|Participant Flow|GSK3003891A Vaccine Formulation 1 Group|Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
11292955|NCT02956837|FG001|Participant Flow|GSK3003891A Vaccine Formulation 2 Group|Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292956|NCT02956837|FG002|Participant Flow|GSK3003891A Vaccine Formulation 3 Group|Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292957|NCT02956837|FG003|Participant Flow|Control Group|Subjects in this group received a single placebo injection at Day 0.
11292958|NCT02956837|OG000|Outcome|GSK3003891A Vaccine Formulation 1 Group|Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292959|NCT02956837|OG001|Outcome|GSK3003891A Vaccine Formulation 2 Group|Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292960|NCT02956837|OG002|Outcome|GSK3003891A Vaccine Formulation 3 Group|Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292961|NCT02956837|OG003|Outcome|Control Group|Subjects in this group received a single placebo injection at Day 0.
11292962|NCT02956837|OG000|Outcome|GSK3003891A Vaccine Formulation 1 Group|Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
11292963|NCT02956837|OG001|Outcome|GSK3003891A Vaccine Formulation 2 Group|Subjects in this group received a single 60 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
11292964|NCT02956837|OG002|Outcome|GSK3003891A Vaccine Formulation 3 Group|Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
11292965|NCT02956837|EG000|Reported Event|GSK3003891A Vaccine Formulation 1 Group|Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
10822219|NCT00075400|FG000|Participant Flow|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
11292966|NCT02956837|EG001|Reported Event|GSK3003891A Vaccine Formulation 2 Group|Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292967|NCT02956837|EG002|Reported Event|GSK3003891A Vaccine Formulation 3 Group|Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
11292968|NCT02956837|EG003|Reported Event|Control Group|Subjects in this group received a single placebo injection at Day 0.
11292969|NCT02956967|BG000|Baseline|Nivestim|Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
11292970|NCT02956967|FG000|Participant Flow|Nivestim|Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 microgram per day (mcg/day) as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
11292971|NCT02956967|OG000|Outcome|Nivestim|Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
11292972|NCT02956967|EG000|Reported Event|Nivestim|Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
11292973|NCT02957123|BG000|Baseline|Intranasal Auto-M2-BFs|Intranasally-Administered Bioactive Factors, Produced by Autologous M2 Macrophage (auto-M2-BFs). 30 patients with organic brain syndrome will receive auto-M2-BFs as intranasal inhalations with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.
11292974|NCT02957123|FG000|Participant Flow|Intranasal Auto-M2-BFs|Intranasally-Administered Bioactive Factors (BF), Produced by Autologous M2 Macrophage (auto-M2-BFs). 30 patients with organic brain syndrome will receive auto-M2-BFs as intranasal inhalations with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.
11292975|NCT02957123|OG000|Outcome|Intranasal Auto-M2-BFs|"Intranasally-Administered Bioactive Factors, Produced by Autologous M2 Macrophage (auto-M2-BFs). M2 macrophages were generated in vitro from peripheral blood of patients during 7 days.Cell-free culture medium, containing auto-M2-BFs, was collected and aliquots of 2 mL/vial were cryopreserved.~30 patients with organic brain syndrome will receive their first doses (n=2-3) of auto-M2-BFs in clinic and wait 2 hrs to determine any short-time adverse effects of inhaled dose.~The subsequent course of intranasal inhalations (once a day up to 30 days) performed as outpatient treatment.~Intranasal auto-M2-BFs: Delivery is performed with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days."
11292976|NCT02957123|EG000|Reported Event|Intranasal Auto-M2-BFs|"Intranasally-Administered Bioactive Factors, Produced by Autologous M2 Macrophage (auto-M2-BFs). M2 macrophages were generated in vitro from peripheral blood of patients during 7 days.Cell-free culture medium, containing auto-M2-BFs, was collected and aliquots of 2 mL/vial were cryopreserved.~30 patients with organic brain syndrome will receive their first doses (n=2-3) of auto-M2-BFs in clinic and wait 2 hrs to determine any short-time adverse effects of inhaled dose.~The subsequent course of intranasal inhalations (once a day up to 30 days) performed as outpatient treatment.~Intranasal auto-M2-BFs: Delivery is performed with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days."
11292977|NCT02957136|BG000|Baseline|Rapid Respiratory Pathogen Test Arm|"ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.~Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel."
11292978|NCT02957136|BG001|Baseline|Usual Care Control Arm|ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
11292979|NCT02957136|BG002|Baseline|Total|Total of all reporting groups
11292980|NCT02957136|FG000|Participant Flow|Rapid Respiratory Pathogen Test Arm|"ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.~Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel."
11292981|NCT02957136|FG001|Participant Flow|Usual Care Control Arm|ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
11292982|NCT02957136|OG000|Outcome|Rapid Respiratory Pathogen Test Arm|"ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.~Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel."
11292983|NCT02957136|OG001|Outcome|Usual Care Control Arm|ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
11292984|NCT02957136|EG000|Reported Event|Rapid Respiratory Pathogen Test Arm|"ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.~Rapid respiratory pathogen nucleic acid amplification test: Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel."
11292985|NCT02957136|EG001|Reported Event|Usual Care Control Arm|ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory.
11292986|NCT02957305|BG000|Baseline|Misoprostol 400 µg|Misoprostol 400 µg 6 hours before Manual Vacuum Aspiration
11292987|NCT02957305|BG001|Baseline|Misoprostol 200|Misoprostol 200 µg 6 hours before Manual Vacuum Aspiration
11292988|NCT02957305|BG002|Baseline|Total|Total of all reporting groups
11292989|NCT02957305|FG000|Participant Flow|Misoprostol 400µg|"Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) were introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.~Misoprostol: 400µg"
11292990|NCT02957305|FG001|Participant Flow|Misoprostol 200µg|"Participants received misoprostol 200 µg: 1 tablet was introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.~Misoprostol: 200µg"
11292991|NCT02957305|OG000|Outcome|Misoprostol 400 µg|"Misoprostol 400 µg 6 hours before intrauterine suction~Misoprostol 400 µg: evaluate the required cervix dilation in the moment of the intrauterine suction"
11292992|NCT02957305|OG001|Outcome|Misoprostol 200 µg|"Misoprostol 200 µg 6 hours before intrauterine suction~Misoprostol 200 µg: evaluate the required cervix dilation in the moment of the intrauterine suction"
11292993|NCT02957305|EG000|Reported Event|Misoprostol 400 µg|Misoprostol 400 µg 6 hours before MVA
11292994|NCT02957305|EG001|Reported Event|Misoprostol 200 µg|Misoprostol 200 µg 6 hours before MVA
11292995|NCT02957331|BG000|Baseline|Propranolol Arm|"One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic <100) or bradycardia (heart rate <60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study.~Propranolol"
11292996|NCT02957331|BG001|Baseline|Non Propranolol Arm|Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
11292997|NCT02957331|BG002|Baseline|Total|Total of all reporting groups
11292998|NCT02957331|FG000|Participant Flow|Propranolol Arm|"One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic <100) or bradycardia (heart rate <60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study.~Propranolol"
11292999|NCT02957331|FG001|Participant Flow|Non Propranolol Arm|Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
11293000|NCT02957331|OG000|Outcome|Propranolol Arm|"One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic <100) or bradycardia (heart rate <60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study.~Propranolol"
11293001|NCT02957331|OG001|Outcome|Non Propranolol Arm|Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
11293002|NCT02957331|EG000|Reported Event|Propranolol Arm|"One half of qualifying and consenting subjects will be randomized to receive propranolol. This group will receive study drug 3 times daily (every 8 hours) starting at 20 mg. The dosage may be increased by up to 60 mg/day divided over three daily doses (or an additional 20 mg/dose) as necessary until the heart rate is less than 100. Study drug will be held for hypotension (systolic <100) or bradycardia (heart rate <60 beats per minute). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study.~Propranolol"
11293003|NCT02957331|EG001|Reported Event|Non Propranolol Arm|Non beta blockade arm will receive standard of care treatment and will not receive beta blockade. If a subject randomized to no Inderal develops hypertension and increased heart rate, he/she will be treated according to standard of care by the trauma team caring for the patient.
11293004|NCT02957357|BG000|Baseline|National Cancer Data Base|Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort.
11293005|NCT02957357|BG001|Baseline|NC ProCESS|The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a prospective population-based cohort of >1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013.
11293006|NCT02957357|BG002|Baseline|Total|Total of all reporting groups
11293007|NCT02957357|FG000|Participant Flow|National Cancer Data Base|Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort.
11293008|NCT02957357|FG001|Participant Flow|NC ProCESS|The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a prospective population-based cohort of >1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013.
11293009|NCT02957357|OG000|Outcome|Low Risk/Radiation|Patients with low-risk prostate cancer treated with radiation therapy
11293010|NCT02957357|OG001|Outcome|Low Risk/Surgery|Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
11293011|NCT02957357|OG002|Outcome|Intermediate Risk/Radiation|Patients with intermediate risk prostate cancer treated with radiation therapy
11293012|NCT02957357|OG003|Outcome|Intermediate Risk/Surgery|Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
11293013|NCT02957357|OG004|Outcome|High Risk/Radiation|Patients with high risk prostate cancer treated with radiation therapy
11293014|NCT02957357|OG005|Outcome|High Risk/Surgery|Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
11293015|NCT02957357|OG000|Outcome|<= 1 PSA Test in Year 1 After Treatment|Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and <=1 PSA tests in the first year after treatment.
11293016|NCT02957357|OG001|Outcome|2 PSA Tests in Year 1 After Treatment|Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and 2 PSA tests in the first year after treatment.
11293017|NCT02957357|OG002|Outcome|>= 3 PSA Tests in Year 1 After Treatment|Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and >=3 PSA tests in the first year after treatment.
11293018|NCT02957357|EG000|Reported Event|National Cancer Data Base|Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort.
11293019|NCT02957357|EG001|Reported Event|NC ProCESS|The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a prospective population-based cohort of >1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013.
11293020|NCT02957682|BG000|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
11293021|NCT02957682|BG001|Baseline|Alirocumab 75 Q2W/Up150 Q2W|Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
11293022|NCT02957682|BG002|Baseline|Total|Total of all reporting groups
11293023|NCT02957682|FG000|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
11293024|NCT02957682|FG001|Participant Flow|Alirocumab 75 Q2W/Up150 Q2W|Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
11293025|NCT02957682|OG000|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
11293026|NCT02957682|OG001|Outcome|Alirocumab 75 Q2W/Up150 Q2W|Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
11293027|NCT02957682|EG000|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
11293028|NCT02957682|EG001|Reported Event|Alirocumab 75 Q2W/Up150 Q2W|Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
11293029|NCT02957747|BG000|Baseline|Safety and Health Experiences Program|"Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.~SHE: SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting."
11293030|NCT02957747|BG001|Baseline|Control|Participants randomized to this arm will receive referrals to VA and community resources
11293031|NCT02957747|BG002|Baseline|Total|Total of all reporting groups
11293032|NCT02957747|FG000|Participant Flow|Safety and Health Experiences Program|"Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.~SHE: SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting."
10822220|NCT00075400|OG000|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
10822221|NCT00075400|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11293033|NCT02957747|FG001|Participant Flow|Control|Participants randomized to this arm will receive referrals to VA and community resources
11293034|NCT02957747|OG000|Outcome|Safety and Health Experiences Program|"Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.~SHE: SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting."
11293035|NCT02957747|OG001|Outcome|Control|Participants randomized to this arm will receive referrals to VA and community resources
11293036|NCT02957747|OG000|Outcome|SHE/Safe and Healthy Experiences Intervention|Only women in the intervention group completed the intervention feedback.
11293037|NCT02957747|EG000|Reported Event|Safety and Health Experiences Program|"Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.~SHE: SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting."
11293038|NCT02957747|EG001|Reported Event|Control|Participants randomized to this arm will receive referrals to VA and community resources
11293039|NCT02957942|BG000|Baseline|Spasmodic Dysphonia|"1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293040|NCT02957942|BG001|Baseline|Healthy Control|"Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293041|NCT02957942|BG002|Baseline|Total|Total of all reporting groups
11293042|NCT02957942|FG000|Participant Flow|Spasmodic Dysphonia|"1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293043|NCT02957942|FG001|Participant Flow|Healthy Control|"Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293044|NCT02957942|OG000|Outcome|Spasmodic Dysphonia|"1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293045|NCT02957942|OG001|Outcome|Healthy Control|"Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293046|NCT02957942|EG000|Reported Event|Spasmodic Dysphonia|"1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
10822222|NCT00075400|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10822223|NCT00075400|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10822224|NCT00075400|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10822225|NCT00075400|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10822226|NCT00075400|EG000|Reported Event|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
10822227|NCT00075478|BG000|Baseline|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
11293047|NCT02957942|EG001|Reported Event|Healthy Control|"Healthy adults 1Hz repetitive transcranial magnetic stimulation (rTMS)~1Hz repetitive transcranial magnetic stimulation (rTMS): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)"
11293048|NCT02958267|BG000|Baseline|BMAC Injection and PRP Injection|"Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.~BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.~PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician."
11293049|NCT02958267|BG001|Baseline|Gel-One® Hyaluronate Injection|"Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).~Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance."
11293050|NCT02958267|BG002|Baseline|Total|Total of all reporting groups
11293051|NCT02958267|FG000|Participant Flow|BMAC Injection and PRP Injection|"Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.~BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.~PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician."
11293052|NCT02958267|FG001|Participant Flow|Gel-One® Hyaluronate Injection|"Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).~Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance."
11293053|NCT02958267|OG000|Outcome|BMAC Injection and PRP Injection|"Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.~BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.~PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician."
11293054|NCT02958267|OG001|Outcome|Gel-One® Hyaluronate Injection|"Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).~Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance."
11293055|NCT02958267|EG000|Reported Event|BMAC Injection and PRP Injection|"Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.~BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.~PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician."
11293056|NCT02958267|EG001|Reported Event|Gel-One® Hyaluronate Injection|"Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).~Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance."
11293057|NCT02958345|BG000|Baseline|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
11293058|NCT02958345|BG001|Baseline|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
11293059|NCT02958345|BG002|Baseline|Total|Total of all reporting groups
11293060|NCT02958345|FG000|Participant Flow|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
11293061|NCT02958345|FG001|Participant Flow|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
11293062|NCT02958345|OG000|Outcome|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
11293063|NCT02958345|OG001|Outcome|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
11293064|NCT02958345|EG000|Reported Event|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.~Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
11293065|NCT02958345|EG001|Reported Event|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.~Placebo: Injection of 0.65 mL of sterile normal saline"
11293066|NCT02958527|BG000|Baseline|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride)|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293067|NCT02958527|FG000|Participant Flow|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride)|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293068|NCT02958527|OG000|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride)|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293069|NCT02958527|OG000|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 1|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293070|NCT02958527|OG001|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293071|NCT02958527|OG002|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293072|NCT02958527|OG003|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293073|NCT02958527|OG004|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293074|NCT02958527|OG005|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293075|NCT02958527|OG006|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293076|NCT02958527|OG000|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Week 12|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293077|NCT02958527|OG001|Outcome|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Week 52|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293078|NCT02958527|EG000|Reported Event|EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride)|Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
11293079|NCT02958553|BG000|Baseline|emPOWER Ankle (Powered Prosthesis)|"The subject's own passive prothesis will be used as a baseline and crossed over after the emPOWER has been worn for 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.~emPOWER Ankle: The deivce is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.~Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline."
11293080|NCT02958553|FG000|Participant Flow|emPOWER Ankle (Powered Prosthesis)|"The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.~emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.~Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline."
11293081|NCT02958553|OG000|Outcome|emPOWER Ankle (Powered Prosthesis)|"The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.~emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.~Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline."
11293082|NCT02958553|EG000|Reported Event|emPOWER Ankle (Powered Prosthesis)|"emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.~The subjects were fit with the emPOWER Ankle and followed for 3-4 months. After crossing over the passive foot and wearing it for 2 weeks, the subjects crossed over back to wearing the emPOWER Ankle up to the 12 months after the initial fitting."
11293083|NCT02958553|EG001|Reported Event|Subject's Own Passive Prosthesis|"Subject's own passive prosthesis: Devices varied.~The subject's own passive prosthesis was used as a baseline/control. No adverse events were collected prior to initial fitting with the emPOWER Ankle. After wearing the emPOWER Ankle for 3-4 months, subjects crossed over back to the passive prosthesis and wore it for 2 weeks. Subjects were crossed over back to the emPOWER for long-term follow up, up to 12 months after the initial fitting."
11293084|NCT02958787|BG000|Baseline|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
11293085|NCT02958787|FG000|Participant Flow|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
11293086|NCT02958787|OG000|Outcome|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
11293087|NCT02958787|EG000|Reported Event|Intervention|"Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures~Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning"
11293088|NCT02958826|BG000|Baseline|Smoke Evacuation Group|Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
11293089|NCT02958826|BG001|Baseline|Control Group|Control group with sham smoke evacuation.
11293090|NCT02958826|BG002|Baseline|Total|Total of all reporting groups
11293091|NCT02958826|FG000|Participant Flow|Smoke Evacuation Group|Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
11293092|NCT02958826|FG001|Participant Flow|Control Group|Control group with sham smoke evacuation.
11293093|NCT02958826|OG000|Outcome|No Smoke Evacuation|"No Smoke Evacuation Group, anonymous questionnaire administered~Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure."
11293094|NCT02958826|OG001|Outcome|Smoke Evacuation|"Smoke Evacuation Group, anonymous questionnaire administered~Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure."
11293095|NCT02958826|OG000|Outcome|Smoke Evacuation Group|Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
11293096|NCT02958826|OG001|Outcome|Control Group|Control group with sham smoke evacuation.
11293097|NCT02958826|EG000|Reported Event|Smoke Evacuation Group|Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
11293098|NCT02958826|EG001|Reported Event|Control Group|Control group with sham smoke evacuation.
11293099|NCT02958956|BG000|Baseline|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
11293100|NCT02958956|BG001|Baseline|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
11293101|NCT02958956|BG002|Baseline|Total|Total of all reporting groups
11293102|NCT02958956|FG000|Participant Flow|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
11293103|NCT02958956|FG001|Participant Flow|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
11293104|NCT02958956|OG000|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
11293105|NCT02958956|OG000|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
11293106|NCT02958956|OG001|Outcome|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
11293107|NCT02958956|EG000|Reported Event|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
11293108|NCT02958956|EG001|Reported Event|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
11293109|NCT02958969|BG000|Baseline|Apixaban|"apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months~Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months"
11293110|NCT02958969|FG000|Participant Flow|Apixaban|"apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months~Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months"
11293111|NCT02958969|OG000|Outcome|Apixaban|"apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months~Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months"
11293112|NCT02958969|EG000|Reported Event|Apixaban|"apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months~Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months"
11293113|NCT02958982|BG000|Baseline|Pooled Placebo (SAD)|Placebo: Participants will receive single oral dose of Placebo in SAD
11293114|NCT02958982|BG001|Baseline|RP3128_25 mg_SAD|RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
11293115|NCT02958982|BG002|Baseline|RP3128_50 mg_SAD|RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
11293116|NCT02958982|BG003|Baseline|RP3128_100 mg_SAD|RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
11293117|NCT02958982|BG004|Baseline|RP3128_200 mg_SAD|RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
11293118|NCT02958982|BG005|Baseline|RP3128_400 mg_SAD|RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
11293119|NCT02958982|BG006|Baseline|Pooled Placebo|Placebo: Participants will receive multiple oral doses of placebo in MAD
11293120|NCT02958982|BG007|Baseline|RP3128_25 mg_MAD|RP3128: Participants will receive multiple oral dose of 25 mg of RP3128 in MAD
11293121|NCT02958982|BG008|Baseline|RP3128_100 mg_MAD|RP3128: Participants will receive multiple oral dose of 100 mg of RP3128 in MAD
11293122|NCT02958982|BG009|Baseline|RP3128_400 mg_MAD|RP3128: Participants will receive multiple oral dose of 400 mg of RP3128 in MAD
11293123|NCT02958982|BG010|Baseline|Proof of Concept|Patient received at least one dose of RP3128/placebo
11293124|NCT02958982|BG011|Baseline|Total|Total of all reporting groups
11293125|NCT02958982|FG000|Participant Flow|Pooled Placebo (SAD)|"Placebo~Placebo: Participants will receive single oral dose of RP3128 in SAD,"
11293126|NCT02958982|FG001|Participant Flow|RP3128_25 mg_SAD|Participants will receive single oral dose of 25 mg of RP3128 once a day in SAD
11293127|NCT02958982|FG002|Participant Flow|RP3128_50 mg_SAD|Participants will receive single oral dose of 50 mg of RP3128 once a day in SAD
11293128|NCT02958982|FG003|Participant Flow|RP3128_100 mg_SAD|Participants will receive single oral dose of 100 mg of RP3128 once a day in SAD
11293129|NCT02958982|FG004|Participant Flow|RP3128_200 mg_SAD|Participants will receive single oral dose of 200 mg of RP3128 once a day in SAD
11293130|NCT02958982|FG005|Participant Flow|RP3128_400 mg_SAD|Participants will receive single oral dose of 400 mg of RP3128 once a day in SAD
11293131|NCT02958982|FG006|Participant Flow|Pooled Placebo (MAD)|"Placebo~Placebo: Participants will receive single oral dose of RP3128 in MAD,"
11293132|NCT02958982|FG007|Participant Flow|RP3128_25 mg_MAD|Participants will receive multiple oral dose of 25 mg of RP3128 for a week in MAD,
11293133|NCT02958982|FG008|Participant Flow|RP3128_100 mg_MAD|Participants will receive multiple oral dose of 100 mg of RP3128 for a week in MAD,
11293134|NCT02958982|FG009|Participant Flow|RP3128_400 mg_MAD|Participants will receive multiple oral dose of 400 mg of RP3128 for a week in MAD,
11293135|NCT02958982|FG010|Participant Flow|Proof of Concept|RP3128/Placebo
11293136|NCT02958982|OG000|Outcome|Pooled Placebo (SAD)|Placebo: Participants will receive single oral dose of RP3128 in SAD,
11293137|NCT02958982|OG001|Outcome|RP3128_25 mg_SAD|RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
11293138|NCT02958982|OG002|Outcome|RP3128_50 mg_SAD|RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
11293139|NCT02958982|OG003|Outcome|RP3128_100 mg_SAD|RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
11293140|NCT02958982|OG004|Outcome|RP3128_200 mg_SAD|RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
11293141|NCT02958982|OG005|Outcome|RP3128_400 mg_SAD|RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
11293142|NCT02958982|OG006|Outcome|Pooled Placebo (MAD)|Placebo: Participants will receive single oral dose of RP3128 in MAD,
11293143|NCT02958982|OG007|Outcome|RP3128_25 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD,
11293144|NCT02958982|OG008|Outcome|RP3128_100 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD study
11293145|NCT02958982|OG009|Outcome|RP3128_400 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD study
11293146|NCT02958982|OG010|Outcome|Proof of Concept|Patient received at least one dose of RP3128/Placebo
11293147|NCT02958982|OG001|Outcome|RP3128_25 mg_SAD|RP3128: Participants will receive single oral dose of 25 mg RP3128 in SAD (Day1)
11293148|NCT02958982|OG002|Outcome|RP3128_50 mg_SAD|RP3128: Participants will receive single oral dose of 50 mg RP3128 in SAD (Day1)
11293149|NCT02958982|OG003|Outcome|RP3128_100 mg_SAD|RP3128: Participants will receive single oral dose of 100 mg RP3128 in SAD (Day1)
11293150|NCT02958982|OG004|Outcome|RP3128_200 mg_SAD|RP3128: Participants will receive single oral dose of 200 mg RP3128 in SAD (Day1)
11293151|NCT02958982|OG005|Outcome|RP3128_400 mg_SAD|RP3128: Participants will receive single oral dose of 400 mg RP3128 in SAD (Day1)
11293152|NCT02958982|OG007|Outcome|RP3128_25 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD (Day 7),
11293153|NCT02958982|OG008|Outcome|RP3128_100 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD (Day 7),
11293154|NCT02958982|OG009|Outcome|RP3128_400 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD (Day 7),
11293155|NCT02958982|OG010|Outcome|Proof of Concept|Participants will RP3128/Placebo
11293156|NCT02958982|EG000|Reported Event|Pooled Placebo (SAD)|Placebo: Participants will receive single oral dose of RP3128 in SAD,
11293157|NCT02958982|EG001|Reported Event|RP3128_25 mg_SAD|RP3128: Participants will receive single oral dose 25 mg of RP3128 in SAD
11293158|NCT02958982|EG002|Reported Event|RP3128_50 mg_SAD|RP3128: Participants will receive single oral dose 50 mg of RP3128 in SAD
11293159|NCT02958982|EG003|Reported Event|RP3128_100 mg_SAD|RP3128: Participants will receive single oral dose 100 mg of RP3128 in SAD
11293160|NCT02958982|EG004|Reported Event|RP3128_200 mg_SAD|RP3128: Participants will receive single oral dose 200 mg of RP3128 in SAD
11293161|NCT02958982|EG005|Reported Event|RP3128_400 mg_SAD|RP3128: Participants will receive single oral dose 400 mg of RP3128 in SAD
11293162|NCT02958982|EG006|Reported Event|Pooled Placebo (MAD)|Placebo: Participants will receive single oral dose of RP3128 in MAD,
11293163|NCT02958982|EG007|Reported Event|RP3128_25 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose 25 mg of RP3128 for one week in MAD,
11293164|NCT02958982|EG008|Reported Event|RP3128_100 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose 100 mg of RP3128 for one week in MAD,
11293165|NCT02958982|EG009|Reported Event|RP3128_400 mg_MAD|RP3128 (MAD): Participants will receive multiple oral dose 400 mg of RP3128 for one week in MAD,
11293166|NCT02958982|EG010|Reported Event|Proof of Concept|Participants will receive RP3128/Placebo
11293167|NCT02958995|BG000|Baseline|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
11293168|NCT02958995|BG001|Baseline|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
11293169|NCT02958995|BG002|Baseline|Total|Total of all reporting groups
11293170|NCT02958995|FG000|Participant Flow|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
11293171|NCT02958995|FG001|Participant Flow|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
11293172|NCT02958995|OG000|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
11293173|NCT02958995|OG001|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
11293174|NCT02958995|EG000|Reported Event|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
11293175|NCT02958995|EG001|Reported Event|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
11293176|NCT02959138|BG000|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293177|NCT02959138|BG001|Baseline|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 20 mg (2 x 10 mg tablets) lanraplenib tablets in a fasted state, on Day 1.
11293178|NCT02959138|BG002|Baseline|Healthy Control|Matched healthy control participants received a single oral dose of 20 mg (2 x 10 mg tablets) lanraplenib tablets in a fasted state, on Day 1.
11293179|NCT02959138|BG003|Baseline|Total|Total of all reporting groups
11293180|NCT02959138|FG000|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293181|NCT02959138|FG001|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293182|NCT02959138|FG002|Participant Flow|Healthy Control|Matched healthy control participants received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293183|NCT02959138|OG000|Outcome|Cohort 1: Moderate Renal Impairment|Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293184|NCT02959138|OG001|Outcome|Cohort 1: Healthy Control|Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293185|NCT02959138|OG002|Outcome|Cohort 2: Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293186|NCT02959138|OG003|Outcome|Cohort 2: Healthy Control|Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
11293187|NCT02959138|OG000|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293188|NCT02959138|OG001|Outcome|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293189|NCT02959138|OG002|Outcome|Healthy Control|Matched healthy control participants received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293190|NCT02959138|EG000|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293191|NCT02959138|EG001|Reported Event|Severe Renal Impairment|Participants with severe renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293192|NCT02959138|EG002|Reported Event|Healthy Control|Matched healthy control participants received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
11293193|NCT02959177|BG000|Baseline|120 mg Galcanezumab|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11293194|NCT02959177|BG001|Baseline|240 mg Galcanezumab|Participants received 240 mg galcanezumab administered SC once a month for 6 months.
11293195|NCT02959177|BG002|Baseline|Placebo|Participants were administered placebo SC once a month for 6 months..
11293196|NCT02959177|BG003|Baseline|Total|Total of all reporting groups
11293197|NCT02959177|FG000|Participant Flow|120 mg Galcanezumab|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous (SC)injection.
11293198|NCT02959177|FG001|Participant Flow|240 mg Galcanezumab|Participants received 240 mg galcanezumab administered SC once a month for 6 months.
11293199|NCT02959177|FG002|Participant Flow|Placebo|Placebo administered SC once a month for 6 months.
11293200|NCT02959177|OG000|Outcome|120 mg Galcanezumab|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11293201|NCT02959177|OG001|Outcome|240 mg Galcanezumab|Participants received 240 mg galcanezumab administered SC once a month for 6 months.
11293202|NCT02959177|OG002|Outcome|Placebo|Participants were administered placebo SC once a month for 6 months.
11293203|NCT02959177|OG000|Outcome|120 mg Galcanezumab|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection..
11293204|NCT02959177|EG000|Reported Event|Treatment Phase Placebo|Participants were administered placebo SC once a month for 6 months.
11293205|NCT02959177|EG001|Reported Event|Treatment Phase 120 mg Galcanezumab|Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
11293206|NCT02959177|EG002|Reported Event|Treatment Phase 240 mg Galcanezumab|Participants received 240 mg galcanezumab administered SC once a month for 6 months.
11293207|NCT02959177|EG003|Reported Event|Follow-up Phase Placebo|Participants did not receive study drug
11293208|NCT02959177|EG004|Reported Event|Follow-up 120 mg Galcanezumab|Participants did not receive study drug
11293209|NCT02959177|EG005|Reported Event|Follow-up Phase 240 mg Galcanezumab|Participants did not receive study drug
11293210|NCT02959190|BG000|Baseline|120mg/120mg Galcanezumab - EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
11293211|NCT02959190|BG001|Baseline|240mg/240mg Galcanezumab - EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
11293212|NCT02959190|BG002|Baseline|Placebo/ 120mg Galcanezumab - EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
11293213|NCT02959190|BG003|Baseline|Placebo/ 240mg Galcanezumab - EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
11293214|NCT02959190|BG004|Baseline|120mg Galcanezumab - CM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
11293215|NCT02959190|BG005|Baseline|240mg Galcanezumab - CM|240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
11293216|NCT02959190|BG006|Baseline|Total|Total of all reporting groups
11293217|NCT02959190|FG000|Participant Flow|120 mg Galcanezumab EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
11293218|NCT02959190|FG001|Participant Flow|240 mg Galcanezumab EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
11293219|NCT02959190|FG002|Participant Flow|120 mg Galcanezumab CM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
11293220|NCT02959190|FG003|Participant Flow|240 mg Galcanezumab CM|240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
11293221|NCT02959190|OG000|Outcome|120mg/120mg Galcanezumab - EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
11293222|NCT02959190|OG001|Outcome|240mg/240mg Galcanezumab - EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
11293223|NCT02959190|OG002|Outcome|Placebo/ 120mg Galcanezumab - EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
11293224|NCT02959190|OG003|Outcome|Placebo/ 240mg Galcanezumab - EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
11293225|NCT02959190|OG004|Outcome|120mg Galcanezumab - CM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
11293226|NCT02959190|OG005|Outcome|240mg Galcanezumab - CM|240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
11293227|NCT02959190|OG001|Outcome|240mg/240mg Galcanezumab - EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
11293228|NCT02959190|EG000|Reported Event|120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
11293229|NCT02959190|EG001|Reported Event|240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
11293230|NCT02959190|EG002|Reported Event|Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
11293231|NCT02959190|EG003|Reported Event|Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM|240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
11293232|NCT02959190|EG004|Reported Event|120mg Galcanezumab - Open-Label Treatment Phase-CM|240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
11293233|NCT02959190|EG005|Reported Event|240mg Galcanezumab - Open-Label Treatment Phase-CM|240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
11293234|NCT02959190|EG006|Reported Event|120mg Galcanezumab - Post-Treatment Phase - EM|Participants didn't received any intervention
11293235|NCT02959190|EG007|Reported Event|240mg Galcanezumab - Post-Treatment Phase - EM|Participants didn't received any intervention
11293236|NCT02959190|EG008|Reported Event|120mg Galcanezumab - Post-Treatment Phase - CM|Participants didn't received any intervention
11293237|NCT02959190|EG009|Reported Event|240mg Galcanezumab - Post-Treatment Phase - CM|Participants didn't received any intervention
11293238|NCT02959307|BG000|Baseline|Transcranial Light Therapy|"Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions."
11293239|NCT02959307|BG001|Baseline|Sham Transcranial Light Therapy|"For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.~Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy."
11293240|NCT02959307|BG002|Baseline|Total|Total of all reporting groups
11293241|NCT02959307|FG000|Participant Flow|Transcranial Light Therapy|"Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions."
11293242|NCT02959307|FG001|Participant Flow|Sham Transcranial Light Therapy|"For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.~Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy."
11293243|NCT02959307|OG000|Outcome|Transcranial Light Therapy|"Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions."
11293244|NCT02959307|OG001|Outcome|Sham Transcranial Light Therapy|"For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.~Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy."
11293245|NCT02959307|EG000|Reported Event|Transcranial Light Therapy|"Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions."
11293246|NCT02959307|EG001|Reported Event|Sham Transcranial Light Therapy|"For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy~Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.~Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy."
11293247|NCT02959437|BG000|Baseline|Treatment Group A :100mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
11293248|NCT02959437|BG001|Baseline|Treatment Group A :300mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
11293249|NCT02959437|BG002|Baseline|Treatment Group B :INCB057643+Pembrolizumab+Epacadostat|In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293250|NCT02959437|BG003|Baseline|Treatment Group C :INCB059872+Pembrolizumab+Epacadostat|In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293251|NCT02959437|BG004|Baseline|Total|Total of all reporting groups
11293252|NCT02959437|FG000|Participant Flow|Treatment Group A :100mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
11293253|NCT02959437|FG001|Participant Flow|Treatment Group A :300mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
11293254|NCT02959437|FG002|Participant Flow|Treatment Group B :INCB057643+Pembrolizumab+Epacadostat|In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293255|NCT02959437|FG003|Participant Flow|Treatment Group C :INCB059872+Pembrolizumab+Epacadostat|In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293256|NCT02959437|OG000|Outcome|Treatment Group A :100mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
11293257|NCT02959437|OG001|Outcome|Treatment Group A :300mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
11293258|NCT02959437|OG002|Outcome|Treatment Group B :INCB057643+Pembrolizumab+Epacadostat|In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293259|NCT02959437|OG003|Outcome|Treatment Group C :INCB059872+Pembrolizumab+Epacadostat|In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293260|NCT02959437|OG000|Outcome|Treatment Group A :100 or 300mg of INCB24360|Treatment Group A :100mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg or 300mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
11293261|NCT02959437|OG001|Outcome|Treatment Group B :INCB057643+Pembrolizumab+Epacadostat|In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293262|NCT02959437|OG002|Outcome|Treatment Group C :INCB059872+Pembrolizumab+Epacadostat|In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
11293263|NCT02959437|EG000|Reported Event|Treatment Group A :100mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
11293264|NCT02959437|EG001|Reported Event|Treatment Group A :300mg of INCB24360|In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
11293265|NCT02959671|BG000|Baseline|Lower Anterior EXD-952 Self-ligating Brackets|Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
11293266|NCT02959671|FG000|Participant Flow|Lower Anterior EXD-952 Self-ligating Brackets|Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
11293267|NCT02959671|OG000|Outcome|Lower Anterior EXD-952 Self-ligating Brackets|Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
11293268|NCT02959671|EG000|Reported Event|Lower Anterior EXD-952 Self-ligating Brackets|Adverse event data was collected from 31 patients out of the 34 who signed the consent. Three participants signed the consent, but did not participate in data collection. They are excluded from data analysis.
11293269|NCT02959814|BG000|Baseline|Patients With Paired QFR, FFR and 2D-QCA|Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria
11293270|NCT02959814|FG000|Participant Flow|Patients With Paired QFR, FFR and 2D-QCA|Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria
11293271|NCT02959814|OG000|Outcome|Patients With Paired QFR, FFR and 2D-QCA|Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria
11293272|NCT02959814|OG000|Outcome|Patients With Measured FFR|Patients with succesfull FFR measurement
11293273|NCT02959814|EG000|Reported Event|Patients With Paired QFR, FFR and 2D-QCA|Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria
11293274|NCT02959827|BG000|Baseline|Iodine Contrast Agent|Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
11293275|NCT02959827|FG000|Participant Flow|Iodine Contrast Agent|Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
11293276|NCT02959827|OG000|Outcome|Iodine Contrast Agent|Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
11293277|NCT02959827|OG000|Outcome|Hypothyroidism Cases|Participants who met the criteria to be a case of hypothyroidism were identified.
11293278|NCT02959827|OG001|Outcome|Non-hypothyroidism Cases|Participants who did not meet the criteria to be a case of hypothyroidism were identified.
11293279|NCT02959827|OG000|Outcome|Hypothyroidism Cases With CT Scan|Participants who had CT scan and met the criteria to be a case of hypothyroidism were identified.
11293280|NCT02959827|OG001|Outcome|Hypothyroidism Cases With Cardiac Catheterization|Participants who had cardiac catheterization and met the criteria to be a case of hypothyroidism were identified.
11293281|NCT02959827|EG000|Reported Event|Iodine Contrast Agent|Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
11293282|NCT02959840|BG000|Baseline|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
11293283|NCT02959840|BG001|Baseline|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
11293284|NCT02959840|BG002|Baseline|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
11293285|NCT02959840|BG003|Baseline|Total|Total of all reporting groups
11293286|NCT02959840|FG000|Participant Flow|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
11293287|NCT02959840|FG001|Participant Flow|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
11293288|NCT02959840|FG002|Participant Flow|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
11293289|NCT02959840|OG000|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
11293290|NCT02959840|OG001|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
11293291|NCT02959840|OG002|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
11293292|NCT02959840|EG000|Reported Event|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
11293293|NCT02959840|EG001|Reported Event|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia~Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.~Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
11293294|NCT02959840|EG002|Reported Event|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
11293295|NCT02959853|BG000|Baseline|Placebo Plus Weight Loss|Patients given a placebo and counseling on diet and exercise in order to achieve a goal weight loss of 10 percent.
11293296|NCT02959853|BG001|Baseline|Aromatase Inhibitor (Anastrazole) Plus Weight Loss|Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
11293297|NCT02959853|BG002|Baseline|Total|Total of all reporting groups
11293298|NCT02959853|FG000|Participant Flow|Weight Loss Plus Placebo|"Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~weight loss"
11293299|NCT02959853|FG001|Participant Flow|Aromatase Inhibitor (Anastrazole) Plus Weight Loss|"Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~Anastrazole~weight loss"
11293300|NCT02959853|OG000|Outcome|Weight Loss|"Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~weight loss"
11293301|NCT02959853|OG001|Outcome|Aromatase Inhibitor (Anastrazole) Plus Weight Loss|"Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~Anastrazole~weight loss"
11293302|NCT02959853|OG000|Outcome|Weight Loss Plus Placebo|"Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~weight loss"
11293303|NCT02959853|EG000|Reported Event|Weight Loss|"Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~weight loss"
11293304|NCT02959853|EG001|Reported Event|Aromatase Inhibitor (Anastrazole) Plus Weight Loss|"Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent~Anastrazole~weight loss"
11293305|NCT02959866|BG000|Baseline|Online Income Tool|"Patients who were reached for follow-up at one month, after using the Online income tool with their healthcare provider: 59~online income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for."
11293306|NCT02959866|FG000|Participant Flow|Online Income Tool|"Patients who complete the online income tool with their health provider during the study period and were enrolled in the study through participation in the evaluation.~Online income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for."
11293307|NCT02959866|OG000|Outcome|Online Income Tool|"Patients who finished using the tool with their healthcare providers and produced a PDF of recommended benefits that they may have been eligible to apply for.~online income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for."
11293308|NCT02959866|OG000|Outcome|Online Income Tool|"Patients who complete the online income tool with their health provider during the study period and were reached for an interview at 1 month follow-up.~Online income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for."
11293309|NCT02959866|EG000|Reported Event|Online Income Tool|"Patients who complete the online income tool with their health provider during the study period.~online income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for."
11293310|NCT02959892|BG000|Baseline|TAK-041 20 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 20 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293311|NCT02959892|BG001|Baseline|TAK-041 40 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 40 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293312|NCT02959892|BG002|Baseline|Total|Total of all reporting groups
11293313|NCT02959892|FG000|Participant Flow|TAK-041 20 mg|[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO) 180 megabecquerel (MBq), injection, intravenously, prior to positron emission tomography (PET) scan on Day 1, followed by amphetamine (AMPH) 0.5 milligram per kilogram (mg/kg), tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 20 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293314|NCT02959892|FG001|Participant Flow|TAK-041 40 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 40 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293315|NCT02959892|OG000|Outcome|TAK-041 20 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 20 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293316|NCT02959892|OG001|Outcome|TAK-041 40 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 40 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293317|NCT02959892|EG000|Reported Event|TAK-041 20 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 20 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293318|NCT02959892|EG001|Reported Event|TAK-041 40 mg|[11C] PHNO 180 MBq, injection, intravenously, prior to PET scan on Day 1, followed by AMPH 0.5 mg/kg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 2 of Confinement Period 1, followed by a 5 to 45 days of interval period, further followed by TAK-041 40 mg, suspension, orally, once, followed by AMPH 0.5 mg, tablet, orally, once and [11C] PHNO 180 MBq, injection, intravenously, prior to PET scan post-AMPH dose on Day 1 of Confinement Period 2.
11293319|NCT02959970|BG000|Baseline|PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
11293320|NCT02959970|BG001|Baseline|Non-PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
11293321|NCT02959970|BG002|Baseline|Total|Total of all reporting groups
11293322|NCT02959970|FG000|Participant Flow|PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
11293323|NCT02959970|FG001|Participant Flow|Non-PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
11293324|NCT02959970|OG000|Outcome|PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
11293325|NCT02959970|OG001|Outcome|Non-PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
11293326|NCT02959970|OG001|Outcome|Non-PK Cohort: ACZONE 7.5%|Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to the their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
11293327|NCT02959970|OG000|Outcome|ACZONE 7.5%|Participants applied ACZONE 7.5% gel topically, once-daily to their face for 12 weeks.
11293328|NCT02959970|EG000|Reported Event|PK Cohort|Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
11293329|NCT02959970|EG001|Reported Event|Non-PK Cohort|Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
11293330|NCT02959983|BG000|Baseline|Eluxadoline|Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
11293331|NCT02959983|BG001|Baseline|Placebo|Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
11293332|NCT02959983|BG002|Baseline|Total|Total of all reporting groups
11293333|NCT02959983|FG000|Participant Flow|Eluxadoline|Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
11293334|NCT02959983|FG001|Participant Flow|Placebo|Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
11293335|NCT02959983|OG000|Outcome|Eluxadoline|Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
11293336|NCT02959983|OG001|Outcome|Placebo|Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
11293337|NCT02959983|EG000|Reported Event|Eluxadoline|Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
11293338|NCT02959983|EG001|Reported Event|Placebo|Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
11293339|NCT02959996|BG000|Baseline|Placebo|"Normal saline will be infiltrated~Placebo: placebo injection in the Pfannenstiel incision"
11293340|NCT02959996|BG001|Baseline|Intervention|"Liposomal bupivacaine will be infiltrated~Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision"
11293341|NCT02959996|BG002|Baseline|Total|Total of all reporting groups
11293342|NCT02959996|FG000|Participant Flow|Placebo|"Normal saline will be infiltrated~Placebo: placebo injection in the Pfannenstiel incision"
11293343|NCT02959996|FG001|Participant Flow|Intervention|"Liposomal bupivacaine will be infiltrated~Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision"
11293344|NCT02959996|OG000|Outcome|Placebo|"Normal saline will be infiltrated~Placebo: placebo injection in the Pfannenstiel incision"
11293345|NCT02959996|OG001|Outcome|Intervention|"Liposomal bupivacaine will be infiltrated~Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision"
11293346|NCT02959996|EG000|Reported Event|Placebo|"Normal saline will be infiltrated~Placebo: placebo injection in the Pfannenstiel incision"
11293347|NCT02959996|EG001|Reported Event|Intervention|"Liposomal bupivacaine will be infiltrated~Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision"
11293348|NCT02960217|BG000|Baseline|Double-Blind UX007 Followed by Placebo|"Double-Blind Maintenance Period: Participants received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks. After a washout period of 2 weeks, they then received placebo for 10 weeks.~Participants had the option of rolling into the Open-Label Extension Period, to continue UX007 treatment for up to 3 years."
11293349|NCT02960217|BG001|Baseline|Double-Blind Placebo Followed by UX007|"Double-Blind Maintenance Period: Participants received placebo for 10 weeks. After a washout period of 2 weeks, they then received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks.~Participants had the option of rolling into the Open-Label Extension Period, to continue UX007 treatment for up to 3 years."
11293350|NCT02960217|BG002|Baseline|Total|Total of all reporting groups
11293351|NCT02960217|FG000|Participant Flow|Double-Blind UX007 Followed by Placebo|"Double-Blind Maintenance Phase: Participants received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks. After a washout period of 2 weeks, they then received placebo for 10 weeks.~Participants had the option of rolling into the Open-Label Extension Phase, to continue UX007 treatment (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for up to 3 years."
11293352|NCT02960217|FG001|Participant Flow|Double-Blind Placebo Followed by UX007|"Double-Blind Maintenance Phase: Participants received placebo for 10 weeks. After a washout period of 2 weeks, they then received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks.~Participants had the option of rolling into the Open-Label Extension Phase, to continue UX007 treatment (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for up to 3 years."
11293353|NCT02960217|OG000|Outcome|Double-Blind UX007|UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks.
11293354|NCT02960217|OG001|Outcome|Double-Blind Placebo|Placebo for 10 weeks.
11293355|NCT02960217|OG000|Outcome|Double-Blind UX007|Double-Blind Maintenance Phase: Participants received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks.
11293356|NCT02960217|OG001|Outcome|Double-Blind Placebo|Double-Blind Maintenance Phase: Participants received placebo for 10 weeks.
11293357|NCT02960217|OG002|Outcome|Open-Label UX007|Open-Label Extension Phase: Participants continued UX007 treatment for up to 3 years.
11293358|NCT02960217|EG000|Reported Event|DB UX007|Double-Blind Maintenance Phase: Participants received UX007 (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for 10 weeks.
11293359|NCT02960217|EG001|Reported Event|DB Placebo|Double-Blind Maintenance Phase: Participants received placebo for 10 weeks.
11293360|NCT02960217|EG002|Reported Event|OL UX007|Open-Label Extension Phase: Participants continued UX007 treatment (dosed according to an age- and weight-based strategy, up to a maximum daily administration of 130 g) for up to 3 years.
11293361|NCT02960295|BG000|Baseline|Virtual Visit|"Pregnant women with GDM who will:~1-self-monitor blood glucose four times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers~Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Self-weighing: Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Checking fetal"
11293362|NCT02960295|FG000|Participant Flow|Virtual Visit|"Pregnant women with gestational diabetes (GDM) who will:~1-self-monitor blood glucose 4 times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers~Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: fasting and 1-hour after each meal. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Self-weighing: Self-weighing on electronic scale at least once a week. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Checking fetal"
11293363|NCT02960295|OG000|Outcome|Virtual Visit|all participants
11293364|NCT02960295|OG000|Outcome|Virtual Visit|"1-Self-monitoring of blood glucose (four times daily). 2-Self-weighing (weekly). 3-Self-checking of blood pressure (weekly). 4-Checking fetal heart rate (weekly). 5-Visits with caregivers.~Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: fasting and 1-hour after each meal. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Intervention: At every office visit and at every telephone (virtual) visit the patient's physician will review glucose results and make adjustments in diet, activity, or medication to bring glucose into desired range.~Self-weighing: Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Consultation with the nutritionist will be obtained for women gaining in excess of or less than that indicated for her"
11293365|NCT02960295|EG000|Reported Event|Virtual Visit|"Pregnant women with GDM who will:~1-self-monitor blood glucose four times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers~Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.~Self-weighing: Self-weighing on electronic scale at least once a week.~Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer.~Checking fetal heart rate: Patient will record her fetus' heart rate with a Doppler device at least once weekly.~Visits with caregivers: Telephone visits will alternate with in-office visits"
11293366|NCT02960438|BG000|Baseline|Placebo|During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293367|NCT02960438|BG001|Baseline|E6011 100 mg|During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293368|NCT02960438|BG002|Baseline|E6011 200 mg|During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293369|NCT02960438|BG003|Baseline|E6011 400/200 mg|During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293370|NCT02960438|BG004|Baseline|Total|Total of all reporting groups
11293371|NCT02960438|FG000|Participant Flow|Placebo|During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 milligram (mg), infusion, subcutaneously, every 2 weeks until Week 102.
11293372|NCT02960438|FG001|Participant Flow|E6011 100 mg|During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293373|NCT02960438|FG002|Participant Flow|E6011 200 mg|During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293374|NCT02960438|FG003|Participant Flow|E6011 400/200 mg|During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293375|NCT02960438|OG000|Outcome|Treatment Phase: Placebo|During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293376|NCT02960438|OG001|Outcome|Treatment Phase: E6011 100 mg|During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293377|NCT02960438|OG002|Outcome|Treatment Phase: E6011 200 mg|During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293378|NCT02960438|OG003|Outcome|Treatment Phase: E6011 400/200 mg|During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293379|NCT02960438|OG004|Outcome|Extension Phase: Placebo|Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293380|NCT02960438|OG005|Outcome|Extension Phase: E6011 100 mg|Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293381|NCT02960438|OG006|Outcome|Extension Phase: E6011 200 mg|Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293382|NCT02960438|OG007|Outcome|Extension Phase: E6011 400/200 mg|Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293383|NCT02960438|EG000|Reported Event|Treatment Phase: Placebo|During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293384|NCT02960438|EG001|Reported Event|Treatment Phase: E6011 100 mg|During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293385|NCT02960438|EG002|Reported Event|Treatment Phase: E6011 200 mg|During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293386|NCT02960438|EG003|Reported Event|Treatment Phase: E6011 400/200 mg|During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.
11293387|NCT02960438|EG004|Reported Event|Extension Phase: Placebo|Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293388|NCT02960438|EG005|Reported Event|Extension Phase: E6011 100 mg|Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293389|NCT02960438|EG006|Reported Event|Extension Phase: E6011 200 mg|Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293390|NCT02960438|EG007|Reported Event|Extension Phase: E6011 400/200 mg|Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
11293391|NCT02960490|BG000|Baseline|Core Treatment Phase: Placebo|During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (Placebo) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293392|NCT02960490|BG001|Baseline|Core Treatment Phase: E6011 400 mg|During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (E6011 400 mg) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293393|NCT02960490|BG002|Baseline|Total|Total of all reporting groups
11293394|NCT02960490|FG000|Participant Flow|Core Treatment Phase: Placebo|During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293395|NCT02960490|FG001|Participant Flow|Core Treatment Phase: E6011 400 mg|During the Core Treatment Phase, participants received E6011 400 milligram (mg), infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293396|NCT02960490|FG002|Participant Flow|Core Treatment Phase: Placebo Then E6011 200 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293397|NCT02960490|FG003|Participant Flow|Core Treatment Phase: Placebo Then E6011 400 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293398|NCT02960490|FG004|Participant Flow|Core Treatment Phase: E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293399|NCT02960490|FG005|Participant Flow|Core Treatment Phase: E6011 400 mg Then E6011 400 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293400|NCT02960490|FG006|Participant Flow|Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293401|NCT02960490|FG007|Participant Flow|Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293402|NCT02960490|FG008|Participant Flow|Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293403|NCT02960490|FG009|Participant Flow|Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
10822228|NCT00075478|BG001|Baseline|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
10822229|NCT00075478|BG002|Baseline|Total|Total of all reporting groups
11293404|NCT02960490|OG000|Outcome|Core Treatment Phase: Placebo|During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293405|NCT02960490|OG001|Outcome|Core Treatment Phase: E6011 400 mg|During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293406|NCT02960490|OG000|Outcome|Core Treatment Phase: Placebo Then E6011 200 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293407|NCT02960490|OG001|Outcome|Core Treatment Phase: Placebo Then E6011 400 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293408|NCT02960490|OG002|Outcome|Core Treatment Phase: E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293409|NCT02960490|OG003|Outcome|Core Treatment Phase: E6011 400 mg Then E6011 400 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293410|NCT02960490|OG004|Outcome|Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293411|NCT02960490|OG005|Outcome|Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293412|NCT02960490|OG006|Outcome|Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293413|NCT02960490|OG007|Outcome|Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293414|NCT02960490|EG000|Reported Event|Core Treatment Phase: Placebo|During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293415|NCT02960490|EG001|Reported Event|Core Treatment Phase: E6011 400 mg|During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
11293416|NCT02960490|EG002|Reported Event|Core Treatment Phase: Placebo Then E6011 200 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293417|NCT02960490|EG003|Reported Event|Core Treatment Phase: Placebo Then E6011 400 mg|Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293418|NCT02960490|EG004|Reported Event|Core Treatment Phase: E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293419|NCT02960490|EG005|Reported Event|Core Treatment Phase: E6011 400 mg Then E6011 400 mg|Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
11293420|NCT02960490|EG006|Reported Event|Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293421|NCT02960490|EG007|Reported Event|Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg|Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293422|NCT02960490|EG008|Reported Event|Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293423|NCT02960490|EG009|Reported Event|Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg|Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
11293424|NCT02960854|BG000|Baseline|Nivolumab (480 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
11293425|NCT02960854|BG001|Baseline|Nivolumab (960 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
11293426|NCT02960854|BG002|Baseline|Total|Total of all reporting groups
11293427|NCT02960854|FG000|Participant Flow|Nivolumab (480 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
11293428|NCT02960854|FG001|Participant Flow|Nivolumab (960 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
11293429|NCT02960854|OG000|Outcome|Nivolumab (480 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
11293430|NCT02960854|OG001|Outcome|Nivolumab (960 mg)|the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
11293431|NCT02960854|EG000|Reported Event|NIVOLUMAB 480mg|the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
11293432|NCT02960854|EG001|Reported Event|NIVOLUMAB 960mg|the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
11293433|NCT02961062|BG000|Baseline|Treatment Sequence 1|Vehicle/SAF312
11293434|NCT02961062|BG001|Baseline|Treatment Sequence 2|SAF312 / Vehicle
11293435|NCT02961062|BG002|Baseline|Total|Total of all reporting groups
11293436|NCT02961062|FG000|Participant Flow|Treatment Sequence 1|Vehicle/SAF312
11293437|NCT02961062|FG001|Participant Flow|Treatment Sequence 2|SAF312 / Vehicle
11293438|NCT02961062|OG000|Outcome|SAF312|treatment participants from both sequences
11293439|NCT02961062|OG001|Outcome|Vehicle|comparator participants from both sequences
11293440|NCT02961062|EG000|Reported Event|SAF312|treatment participants from both sequences
11293441|NCT02961062|EG001|Reported Event|Vehicle|Vehicle
11293442|NCT02961218|BG000|Baseline|ACZ885|Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293443|NCT02961218|BG001|Baseline|Placebo|Monthly doses of placebo to match the administered dose of ACZ885 s.c.
11293444|NCT02961218|BG002|Baseline|Total|Total of all reporting groups
11293445|NCT02961218|FG000|Participant Flow|ACZ885|Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293446|NCT02961218|FG001|Participant Flow|Placebo|Monthly doses of placebo to match the administered dose of ACZ885 s.c.
11293447|NCT02961218|OG000|Outcome|ACZ885|Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293448|NCT02961218|OG001|Outcome|Placebo|Monthly doses of placebo to match the administered dose of ACZ885 s.c.
11293449|NCT02961218|EG000|Reported Event|ACZ885|Double-blind period (Week 0 to 24): Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293450|NCT02961218|EG001|Reported Event|Placebo|Double-blind period (Week 0 to 24): Monthly doses of placebo to match the administered dose of ACZ885 s.c.
11293451|NCT02961218|EG002|Reported Event|ACZ885 / ACZ885|Open label Phase (after Week 24 to Week 56) for the participants originally randomized to ACZ885: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293452|NCT02961218|EG003|Reported Event|Placebo / ACZ885|Open label Phase (after Week 24 to Week 56) for the participants originally randomized to placebo: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
11293453|NCT02961244|BG000|Baseline|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
11293454|NCT02961244|BG001|Baseline|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
11293455|NCT02961244|BG002|Baseline|Total|Total of all reporting groups
11293456|NCT02961244|FG000|Participant Flow|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
11293457|NCT02961244|FG001|Participant Flow|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
11293458|NCT02961244|OG000|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
11293459|NCT02961244|OG001|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
11293460|NCT02961244|EG000|Reported Event|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
11293461|NCT02961244|EG001|Reported Event|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
11293462|NCT02961751|BG000|Baseline|Ciprofloxacin|One dose of directly-observed ciprofloxacin 500 mg administered orally
11293463|NCT02961751|FG000|Participant Flow|Ciprofloxacin|One dose of directly-observed ciprofloxacin 500 mg administered orally.
11293464|NCT02961751|OG000|Outcome|Ciprofloxacin|One dose of directly-observed ciprofloxacin 500 mg administered orally
11293465|NCT02961751|EG000|Reported Event|Ciprofloxacin|One dose of directly-observed ciprofloxacin 500 mg administered orally
11293466|NCT02961764|BG000|Baseline|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11293467|NCT02961764|BG001|Baseline|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11293468|NCT02961764|BG002|Baseline|Total|Total of all reporting groups
11293469|NCT02961764|FG000|Participant Flow|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11293470|NCT02961764|FG001|Participant Flow|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11293471|NCT02961764|OG000|Outcome|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11293472|NCT02961764|OG001|Outcome|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11293473|NCT02961764|EG000|Reported Event|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11293474|NCT02961764|EG001|Reported Event|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11293475|NCT02961790|BG000|Baseline|High-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
11293476|NCT02961790|BG001|Baseline|Low-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
11293477|NCT02961790|BG002|Baseline|High-dose Placebo Group|Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
11293478|NCT02961790|BG003|Baseline|Low-dose Placebo Group|Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
11293479|NCT02961790|BG004|Baseline|Total|Total of all reporting groups
11293480|NCT02961790|FG000|Participant Flow|High-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
11293481|NCT02961790|FG001|Participant Flow|Low-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
11293482|NCT02961790|FG002|Participant Flow|High-dose Placebo Group|Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
11293483|NCT02961790|FG003|Participant Flow|Low-dose Placebo Group|Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
11293484|NCT02961790|OG000|Outcome|High-dose Oxybutynin Chloride Group|Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
11293485|NCT02961790|OG001|Outcome|Low-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
11293486|NCT02961790|OG002|Outcome|Placebo Group|Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
11293487|NCT02961790|OG000|Outcome|Low-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
11293488|NCT02961790|OG001|Outcome|Placebo Group|Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
11293489|NCT02961790|OG000|Outcome|High-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
11293490|NCT02961790|EG000|Reported Event|High-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
11293491|NCT02961790|EG001|Reported Event|Low-dose Oxybutynin Chloride Group|Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
11293492|NCT02961790|EG002|Reported Event|Placebo Group|Patients receive placebo regardless of dose level in the absence of unacceptable toxicity.
11293493|NCT02961894|BG000|Baseline|Revolution Treatment Arm|"This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.~Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options."
11293494|NCT02961894|FG000|Participant Flow|Revolution Treatment Arm|"This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.~Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options."
11293495|NCT02961894|OG000|Outcome|Revolution Treatment Arm|"This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.~Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options."
11293496|NCT02961894|EG000|Reported Event|Revolution Treatment Arm|"This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.~Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options."
11293497|NCT02961920|BG000|Baseline|IE Ratio 1:1|"Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients."
11293498|NCT02961920|BG001|Baseline|IE Ratio 1:2|"Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients."
11293499|NCT02961920|BG002|Baseline|Total|Total of all reporting groups
11293500|NCT02961920|FG000|Participant Flow|IE Ratio 1:2|Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.
11293501|NCT02961920|FG001|Participant Flow|IE Ratio 1:1|Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
11293502|NCT02961920|OG000|Outcome|IE Ratio 1:2|"Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients."
11293503|NCT02961920|OG001|Outcome|IE Ratio 1:1|"Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients."
11293504|NCT02961920|EG000|Reported Event|IE Ratio 1:2|"Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients."
11293505|NCT02961920|EG001|Reported Event|IE Ratio 1:1|"Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.~IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients."
10848228|NCT00289185|FG001|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
11293506|NCT02961946|BG000|Baseline|Sublingual Nitroglycerin Spray|"Sublingual Nitroglycerin spray of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293507|NCT02961946|BG001|Baseline|Sublingual Nitroglycerin Tablet|"Sublingual Nitroglycerin tablet of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293508|NCT02961946|BG002|Baseline|Nitroglycerin Skin Patch|"Nitroglycerin skin patch of 0.8 mg/h~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293509|NCT02961946|BG003|Baseline|Total|Total of all reporting groups
11293510|NCT02961946|FG000|Participant Flow|Sublingual Nitroglycerin Spray|"Sublingual Nitroglycerin spray of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293511|NCT02961946|FG001|Participant Flow|Sublingual Nitroglycerin Tablet|"Sublingual Nitroglycerin tablet of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293512|NCT02961946|FG002|Participant Flow|Nitroglycerin Skin Patch|"Nitroglycerin skin patch of 0.8 mg/h~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293513|NCT02961946|OG000|Outcome|Sublingual Nitroglycerin Spray|"Sublingual Nitroglycerin spray of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293514|NCT02961946|OG001|Outcome|Sublingual Nitroglycerin Tablet|"Sublingual Nitroglycerin tablet of 0.8 mg~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293515|NCT02961946|OG002|Outcome|Nitroglycerin Skin Patch|"Nitroglycerin skin patch of 0.8 mg/h~Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm."
11293516|NCT02961946|EG000|Reported Event|Sublingual Nitroglycerin Spray|"Sublingual Nitroglycerin spray of 0.8 mg~Patients will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan."
11293517|NCT02961946|EG001|Reported Event|Sublingual Nitroglycerin Tablet|"Sublingual Nitroglycerin tablet of 0.8 mg~Patients will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan."
11293518|NCT02961946|EG002|Reported Event|Nitroglycerin Skin Patch|"Nitroglycerin skin patch of 0.8 mg/h~Patients categorized to transdermal administration will receive Nitroglycerin after Calcium scoring scan and 1 hour before the cCTA examination. The patch will be placed on the chest or the upper arm."
11293519|NCT02962284|BG000|Baseline|Preceding Treatment - Yonsa|84-days treatment
11293520|NCT02962284|BG001|Baseline|Preceding Treatment - Zytiga|84 day treatment
11293521|NCT02962284|BG002|Baseline|Total|Total of all reporting groups
11293522|NCT02962284|FG000|Participant Flow|Preceding Treatment - Yonsa|84-days treatment: Yonsa 500 mg orally once daily with methylprednisolon
11293523|NCT02962284|FG001|Participant Flow|Preceding Treatment - Zytiga|Yonsa 500 mg orally once daily with methylprednisolon
11293524|NCT02962284|OG000|Outcome|Preceding Treatment - Yonsa|one year treatment
11293525|NCT02962284|OG001|Outcome|Preceding Treatment - Zytiga|one year treatment
11293526|NCT02962284|OG000|Outcome|Preceding Treatment - Yonsa|84-days treatment
11293527|NCT02962284|OG001|Outcome|Preceding Treatment - Zytiga|84 day treatment
11293528|NCT02962284|EG000|Reported Event|Preceding Treatment - Yonsa|one year treatment
11293529|NCT02962284|EG001|Reported Event|Preceding Treatment - Zytiga|one year treatment
11293530|NCT02962427|BG000|Baseline|Sphenopalatine Ganglion Block|"Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.~Sphenopalatine ganglion Block"
11293531|NCT02962427|BG001|Baseline|Epidural Blood Patch|"Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.~Epidural blood patch"
11293532|NCT02962427|BG002|Baseline|Total|Total of all reporting groups
11293533|NCT02962427|FG000|Participant Flow|Sphenopalatine Ganglion Block|"Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.~Sphenopalatine ganglion Block"
11293534|NCT02962427|FG001|Participant Flow|Epidural Blood Patch|"Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.~Epidural blood patch"
11293535|NCT02962427|OG000|Outcome|Sphenopalatine Ganglion Block Baseline Score|"Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.~Sphenopalatine ganglion Block"
11293536|NCT02962427|OG001|Outcome|Sphenopalatine Ganglion Block 48 Hours Score|"Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.~Sphenopalatine ganglion Block"
11293537|NCT02962427|OG002|Outcome|Epidural Blood Patch Baseline Score|"Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.~Epidural blood patch"
11293538|NCT02962427|OG003|Outcome|Epidural Blood Patch 48 Hours Score|"Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.~Epidural blood patch"
11293539|NCT02962427|EG000|Reported Event|Sphenopalatine Ganglion Block|"Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.~Sphenopalatine ganglion Block"
11293540|NCT02962427|EG001|Reported Event|Epidural Blood Patch|"Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.~Epidural blood patch"
11293541|NCT02962609|BG000|Baseline|Semielevated Side-Lying Position-ESL|"Feeding Position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293542|NCT02962609|BG001|Baseline|Semielevated Supine Position-ESU|"Feeding Position. In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293543|NCT02962609|BG002|Baseline|Total|Total of all reporting groups
11293544|NCT02962609|FG000|Participant Flow|Semielevated Side-Lying Position-ESL|"Feeding Position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293545|NCT02962609|FG001|Participant Flow|Semielevated Supine Position-ESU|"Feeding Position. In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293546|NCT02962609|OG000|Outcome|Semielevated Side-Lying Position-ESL|"Feeding Position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293547|NCT02962609|OG001|Outcome|Semielevated Supine Position-ESU|"Feeding Position. In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293548|NCT02962609|EG000|Reported Event|Semielevated Side-Lying Position-ESL|"Feeding Position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293549|NCT02962609|EG001|Reported Event|Semielevated Supine Position-ESU|"Feeding Position. In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor.~Feeding Position: Semielevated side-lying position (ESL): Experimental Group Semielevated supine position (ESU): Control Group"
11293550|NCT02962648|BG000|Baseline|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11293551|NCT02962648|FG000|Participant Flow|Iron Isomaltoside/Ferric Derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit."
11293552|NCT02962648|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11293553|NCT02962648|EG000|Reported Event|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11293554|NCT02962674|BG000|Baseline|Treatment|Subjects treated with the prostaFix System
11293555|NCT02962674|FG000|Participant Flow|prostaFix System|Subjects treated with the prostaFix Water Electrolysis System
11293556|NCT02962674|OG000|Outcome|prostaFix System|Subjects treated with the prostaFix Water Electrolysis System
11293557|NCT02962674|OG000|Outcome|protaFix System|Subjects treated with the prostaFix Water Electrolysis System
11293558|NCT02962674|OG000|Outcome|Treatment|Subjects treated with the prostaFix System
11293559|NCT02962674|EG000|Reported Event|prostaFix System|Subjects treated with the prostaFix Water Electrolysis System
11293560|NCT02962687|BG000|Baseline|Videoconference Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing~Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference"
11293561|NCT02962687|BG001|Baseline|Telephone Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via telephone calls~Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls"
11293562|NCT02962687|BG002|Baseline|Total|Total of all reporting groups
11293563|NCT02962687|FG000|Participant Flow|Videoconference Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing~Care management via videoconference: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via videoconference"
11293564|NCT02962687|FG001|Participant Flow|Telephone Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via telephone calls~Care management via telephone calls: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via telephone calls"
11293565|NCT02962687|OG000|Outcome|Videoconference Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing~Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference"
11293566|NCT02962687|OG001|Outcome|Telephone Care Management|"12-week nurse care management for medically complex Veterans with CI delivered via telephone calls~Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls"
11293567|NCT02962687|EG000|Reported Event|Videoconference Care Management - Veterans|"12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing~Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference"
11293568|NCT02962687|EG001|Reported Event|Telephone Care Management - Veterans|"12-week nurse care management for medically complex Veterans with CI delivered via telephone calls~Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls"
10971014|NCT00913458|EG002|Reported Event|MTX + PBO (Phase 2)|"In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.~Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
10971015|NCT00913458|EG003|Reported Event|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
10971016|NCT00913458|EG004|Reported Event|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
10971017|NCT00913458|EG005|Reported Event|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
10971018|NCT00913458|EG006|Reported Event|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
10971019|NCT00913510|BG000|Baseline|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
11293569|NCT02962687|EG002|Reported Event|Videoconference Care Management - Care Partners|"12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconferencing~Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconference"
11293570|NCT02962687|EG003|Reported Event|Telephone Care Management - Care Partners|"12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls~Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls"
11293571|NCT02962739|BG000|Baseline|All Dosing Regimens|Baseline characteristics for all 35 subjects analyzed. Baseline characteristics not stratified based on dosing regimen. Arms were combined to be consistent with protocol subject randomization. Subjects were randomized to one of six arms. Combined arms best categorize the study, population, and data.
10971020|NCT00913510|BG001|Baseline|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
10971021|NCT00913510|BG002|Baseline|Total|Total of all reporting groups
10971022|NCT00913510|FG000|Participant Flow|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.
11293572|NCT02962739|FG000|Participant Flow|33%/67% Dosing|"The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293573|NCT02962739|FG001|Participant Flow|33%/100% Dosing|"The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293574|NCT02962739|FG002|Participant Flow|67%/33% Dosing|"The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293575|NCT02962739|FG003|Participant Flow|67%/100% Dosing|"67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293576|NCT02962739|FG004|Participant Flow|100%/33% Dosing|"The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293577|NCT02962739|FG005|Participant Flow|100%/67% Dosing|"67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.~emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg"
11293578|NCT02962739|OG000|Outcome|DOT 33%|33% of daily dosing; dosing on day one followed by skipped doses on days two and three, repeated for 12 weeks
11293579|NCT02962739|OG001|Outcome|DOT 67%|67% of daily dosing; dosing on days one and two, skipped dose on day three, repeated for 12 weeks
11293580|NCT02962739|OG002|Outcome|DOT 100%|100% of daily dosing:dosing every day for 12 weeks
11293581|NCT02962739|EG000|Reported Event|All Subjects|At study initiation Descovy was FDA approved for daily dosing (100% daily dosing). Thus, the AE profile was already established for 100% dosing and AE rates in the lower doses (33% and 67%) would not exceed the established rate for daily dosing (100%). This study was not designed to collect new safety data or to update the established AE/Safety profiles for Descovy. Therefore AE data was combined for all dosing regimens.
11293582|NCT02962765|BG000|Baseline|Nuwiq® (Human-cl rhFVIII) SAF Population|The safety (SAF) population consist of all patients who received at least one infusion of Human-cl rhFVIII (n=78)
11293583|NCT02962765|FG000|Participant Flow|Nuwiq® (Human-cl rhFVIII)|"A total of 80 patients were enrolled in this study.~Of the 80 patients enrolled into the study, 2 were excluded because they had not received any treatment with Nuwiq, leaving 78 patients in the full analysis population (FAS) and safety population (SAF).~Of these, 77 patients were part of the prophylactic treatment group and 2 patients were in the on-demand treatment group.~One patient changed regimen from on-demand treatment to prophylactic treatment and back to on-demand treatment while in the study. Corresponding data for this patient in included in both the prophylactic and on-demand treatment groups.~The treatment regimen, doses, dosing intervals and dose adjustments were determined at the discretion of the treating physician. A usual dose for long-term prophylaxis against bleeding in patients with severe hemophilia A is 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.~Of the 78 total patients, 17 were excluded for the reasons summarized below."
11293584|NCT02962765|OG000|Outcome|FVIII Inhibitors Detected at Screening in Patients Treated With Nuwiq®|FVIII inhibitors detected in the FAS population at screening.
11293585|NCT02962765|OG001|Outcome|FVIII Inhibitors Detected Between Screening and Completion in Patients Treated With Nuwiq®|FVIII inhibitors detected in the FAS population between screening and study completion
11293586|NCT02962765|OG002|Outcome|FVIII Inhibitors Detected at Completion in Patients Treated With Nuwiq® (Human-cl rhFVIII)|FVIII inhibitors detected in the FAS population at study completion
10971023|NCT00913510|FG001|Participant Flow|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
11293587|NCT02962765|OG000|Outcome|Nuwiq® (Human-cl rhFVIII) FAS Population|All patients who received at least one infusion of Nuwiq® (Human-cl rhFVIII) and for whom at least one measurement after screening was available
11293588|NCT02962765|OG000|Outcome|Nuwiq® in Prophylactic Treatment|Patients with at least 3 months routine prophylactic treatment with Nuwiq
11293589|NCT02962765|OG000|Outcome|Nuwiq® (Human-cl rhFVIII) in On Demand Population|Efficacy of Nuwiq in the treatment of bleeding episodes (BEs) in patients who were under on-demand treatment
11293590|NCT02962765|OG000|Outcome|Nuwiq® (Human-cl rhFVIII) Surgical Prophylaxis|4 patients had in total 6 surgeries and were included in the SURG population.
11293591|NCT02962765|OG000|Outcome|Nuwiq in Prophylactic Population|Efficacy of Nuwiq in the treatment of bleeding episodes in patients who were under prophylactic treatment
11293592|NCT02962765|EG000|Reported Event|Nuwiq® (Human-cl rhFVIII) SAF Population|Adverse events were reported for the SAF population which consist of all patients who received at least one infusion of Human-cl rhFVIII (n=78). Due to no reported adverse events related to treatment with Nuwiq, AEs were not reported separately for prophylactic or on-demand interventions.
11293593|NCT02962882|BG000|Baseline|Mepilex Border Dressing Heel and Sacrum Together|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
10971024|NCT00913510|OG000|Outcome|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
11293594|NCT02962882|FG000|Participant Flow|Mepilex Border Dressing All|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
11293595|NCT02962882|OG000|Outcome|Mepilex Border Dressing Heel|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
11293596|NCT02962882|OG001|Outcome|Mepilex Border Dressing Sacrum|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
11293597|NCT02962882|EG000|Reported Event|Mepilex Border Dressing All|"A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).~Mepilex Border: Multi-layer Foam Dressings"
11293598|NCT02962908|BG000|Baseline|2x Non-adjuvanted FLU-v|"FLU-v on Day 0 and Day 21~FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH"
11293599|NCT02962908|BG001|Baseline|1x Adjuvanted FLU-v|"adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293600|NCT02962908|BG002|Baseline|Non-adjuvanted Placebo|"saline solution (0.5ml) on Day 0 and Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293601|NCT02962908|BG003|Baseline|Adjuvanted Placebo|"Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline~Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection"
11293602|NCT02962908|BG004|Baseline|Total|Total of all reporting groups
11293603|NCT02962908|FG000|Participant Flow|2x Non-adjuvanted FLU-v|"FLU-v on Day 0 and Day 21~FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH"
10971025|NCT00913510|OG001|Outcome|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
10971026|NCT00913510|EG000|Reported Event|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
10971027|NCT00913510|EG001|Reported Event|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
10971028|NCT00913523|BG000|Baseline|Tampon With GML|Regular and Super Tampon with GML added to the cover
11293604|NCT02962908|FG001|Participant Flow|1x Adjuvanted FLU-v|"adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293605|NCT02962908|FG002|Participant Flow|Non-adjuvanted Placebo|"saline solution (0.5ml) on Day 0 and Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293606|NCT02962908|FG003|Participant Flow|Adjuvanted Placebo|"Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline~Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection"
10971029|NCT00913523|BG001|Baseline|Tampon Without GML|Regular and Super Tampon without GML added to the cover
10971030|NCT00913523|BG002|Baseline|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
10971031|NCT00913523|BG003|Baseline|Total|Total of all reporting groups
10971032|NCT00913523|FG000|Participant Flow|Tampon With GML|Regular and Super Tampon with GML added to the cover
10971033|NCT00913523|FG001|Participant Flow|Tampon Without GML|Regular and Super Tampon without GML added to the cover
10971034|NCT00913523|FG002|Participant Flow|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
10971035|NCT00913523|OG000|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
10971036|NCT00913523|OG001|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
10971037|NCT00913523|OG002|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
10971038|NCT00913523|EG000|Reported Event|Tampon With GML|Regular and Super Tampon with GML added to the cover
10971039|NCT00913523|EG001|Reported Event|Tampon Without GML|Regular and Super Tampon without GML added to the cover
10971040|NCT00913523|EG002|Reported Event|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
10971041|NCT00913627|BG000|Baseline|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
10971042|NCT00913627|BG001|Baseline|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
10971043|NCT00913627|BG002|Baseline|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
10971044|NCT00913627|BG003|Baseline|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
11293607|NCT02962908|OG000|Outcome|2x Non-adjuvanted FLU-v|"FLU-v on Day 0 and Day 21~FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH"
11293608|NCT02962908|OG001|Outcome|1x Adjuvanted FLU-v|"adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293609|NCT02962908|OG002|Outcome|Non-adjuvanted Placebo|"saline solution (0.5ml) on Day 0 and Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293610|NCT02962908|OG003|Outcome|Adjuvanted Placebo|"Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline~Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection"
11293611|NCT02962908|OG000|Outcome|2x Non-adjuvanted FLU-v, Previous Vaccination Within 2 Years|participants who had received an influenza vaccination in the previous 2 years, and who received FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH
11293612|NCT02962908|OG001|Outcome|1x Adjuvanted FLU-v, Previous Vaccination Within 2 Years|"participants who had received an influenza vaccination in the previous 2 years, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293613|NCT02962908|OG002|Outcome|Combined Placebo, Previous Vaccination Within 2 Years|"participants who had received an influenza vaccination in the previous 2 years, and who received either non-adjuvanted placebo or adjuvanted placebo~Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21~Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection"
11293614|NCT02962908|OG003|Outcome|2x Non-adjuvanted FLU-v, no Previous Vaccination|"Participants who had not ever previously received an influenza vaccination, and who received FLU-v on Day 0 and Day 21~FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH"
10971045|NCT00913627|BG004|Baseline|Total|Total of all reporting groups
10971046|NCT00913627|FG000|Participant Flow|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
11293615|NCT02962908|OG004|Outcome|1x Adjuvanted FLU-v, no Previous Vaccination|"participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293616|NCT02962908|OG005|Outcome|Combined Placebo, no Previous Vaccination|"participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo~Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21~Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21"
11293617|NCT02962908|EG000|Reported Event|2x Non-adjuvanted FLU-v|"FLU-v on Day 0 and Day 21~FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH"
11293618|NCT02962908|EG001|Reported Event|1x Adjuvanted FLU-v|"adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21~adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293619|NCT02962908|EG002|Reported Event|Non-adjuvanted Placebo|"saline solution (0.5ml) on Day 0 and Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline"
11293620|NCT02962908|EG003|Reported Event|Adjuvanted Placebo|"Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21~Saline: Subcutaneous injection in the upper arm with 0.5ml of saline~Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection"
11293621|NCT02962934|BG000|Baseline|Non CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy~Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h."
11293622|NCT02962934|BG001|Baseline|CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy~CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.~Ultrafiltrate samples at 1 hr,2h 4h 6h 8h"
11293623|NCT02962934|BG002|Baseline|Total|Total of all reporting groups
11293624|NCT02962934|FG000|Participant Flow|Non CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy~Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h."
11293625|NCT02962934|FG001|Participant Flow|CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy~CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.~Ultrafiltrate samples at 1 hr,2h 4h 6h 8h"
11293626|NCT02962934|OG000|Outcome|Non CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy~Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h."
11293627|NCT02962934|OG001|Outcome|CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy~CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.~Ultrafiltrate samples at 1 hr,2h 4h 6h 8h"
11293628|NCT02962934|EG000|Reported Event|Non CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy~Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h."
11293629|NCT02962934|EG001|Reported Event|CRRT Group|"Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy~CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.~Ultrafiltrate samples at 1 hr,2h 4h 6h 8h"
11293630|NCT02962960|BG000|Baseline|Anifrolumab - Lower Dose|1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
11293631|NCT02962960|BG001|Baseline|Anifrolumab - Higher Dose|2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
11293632|NCT02962960|BG002|Baseline|Placebo Comparator|Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
11293633|NCT02962960|BG003|Baseline|Total|Total of all reporting groups
11293634|NCT02962960|FG000|Participant Flow|Anifrolumab - Lower Dose|1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
11293635|NCT02962960|FG001|Participant Flow|Anifrolumab - Higher Dose|2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
11293636|NCT02962960|FG002|Participant Flow|Placebo Comparator|Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
11293637|NCT02962960|OG000|Outcome|Anifrolumab - Lower Dose|1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
11293638|NCT02962960|OG001|Outcome|Anifrolumab - Higher Dose|2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
11293639|NCT02962960|OG002|Outcome|Placebo Comparator|Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
11293640|NCT02962960|OG002|Outcome|Placebo Comparator to Lower Dose|Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50
11293641|NCT02962960|OG003|Outcome|Placebo Comparator to Higher Dose|Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
10971047|NCT00913627|FG001|Participant Flow|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
11293642|NCT02962960|EG000|Reported Event|Anifrolumab - Lower Dose|1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
11293643|NCT02962960|EG001|Reported Event|Anifrolumab - Higher Dose|2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
11293644|NCT02962960|EG002|Reported Event|Placebo Comparator|Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
11293645|NCT02963311|BG000|Baseline|Inclisiran|"300 milligrams (mg) administered subcutaneous (SC) on Day 1. Participants with a mean serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels not suppressed by >70% at Day 60 or Day 90, as compared to baseline, will receive a second dose at Day 90 or Day 104, respectively, based on PCSK9 levels from the previous visit. Participants also received standard of care as background therapy.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.~Standard of Care: Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies."
11293646|NCT02963311|FG000|Participant Flow|Inclisiran|"300 milligrams (mg) administered subcutaneous (SC) on Day 1. Participants with a mean serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels not suppressed by >70% at Day 60 or Day 90, as compared to baseline, will receive a second dose at Day 90 or Day 104, respectively, based on PCSK9 levels from the previous visit. Participants also received standard of care as background therapy.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.~Standard of Care: Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies."
11293647|NCT02963311|OG000|Outcome|Inclisiran|"300 milligrams (mg) administered subcutaneous (SC) on Day 1. Participants with a mean serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels not suppressed by >70% at Day 60 or Day 90, as compared to baseline, will receive a second dose at Day 90 or Day 104, respectively, based on PCSK9 levels from the previous visit. Participants also received standard of care as background therapy.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.~Standard of Care: Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies."
11293648|NCT02963311|EG000|Reported Event|Inclisiran|"300 milligrams (mg) administered subcutaneous (SC) on Day 1. Participants with a mean serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels not suppressed by >70% at Day 60 or Day 90, as compared to baseline, will receive a second dose at Day 90 or Day 104, respectively, based on PCSK9 levels from the previous visit. Participants also received standard of care as background therapy.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.~Standard of Care: Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies."
11293649|NCT02963376|BG000|Baseline|Controls (n=6)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~For analysis, all control subjects are grouped."
11293650|NCT02963376|BG001|Baseline|DDFPe - 0.05 mL/kg (n=6)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293651|NCT02963376|BG002|Baseline|DDFPe - 0.10 mL/kg (n=6)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293652|NCT02963376|BG003|Baseline|DDFPe - 0.17 mL/kg (n=6)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293653|NCT02963376|BG004|Baseline|Total|Total of all reporting groups
11293654|NCT02963376|FG000|Participant Flow|0.05 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.05 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg)."
11293655|NCT02963376|FG001|Participant Flow|0.05 mL/kg Placebo|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.05 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg)."
11293656|NCT02963376|FG002|Participant Flow|0.10 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.10 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg)."
11293657|NCT02963376|FG003|Participant Flow|0.10 mL/kg Placebo|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.10 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg)."
11293658|NCT02963376|FG004|Participant Flow|0.17 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.17 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg)."
11293659|NCT02963376|FG005|Participant Flow|0.17 mL/kg Placebo|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.17 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg)."
11293660|NCT02963376|OG000|Outcome|0.05 mL/kg DDFPe|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293661|NCT02963376|OG001|Outcome|0.05 mL/kg Placebo|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293662|NCT02963376|OG002|Outcome|0.10 mL/kg DDFPe|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
10971048|NCT00913627|FG002|Participant Flow|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
10971049|NCT00913627|FG003|Participant Flow|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
10971050|NCT00913627|OG000|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
10971051|NCT00913627|OG001|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
10971052|NCT00913627|OG002|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
10971053|NCT00913627|OG003|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
10971054|NCT00913627|EG000|Reported Event|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
10971055|NCT00913627|EG001|Reported Event|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
10971056|NCT00913627|EG002|Reported Event|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
10971057|NCT00913627|EG003|Reported Event|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
10971058|NCT00913744|BG000|Baseline|Ocriplasmin|Intravitreal injection (125 µg)
10971059|NCT00913744|BG001|Baseline|Sham|Sham injection
10971060|NCT00913744|BG002|Baseline|Total|Total of all reporting groups
10971061|NCT00913744|FG000|Participant Flow|Ocriplasmin|Intravitreal injection (125 µg)
10971062|NCT00913744|FG001|Participant Flow|Sham|Sham injection
10971063|NCT00913744|OG000|Outcome|Ocriplasmin|Intravitreal injection (125 µg)
10971064|NCT00913744|OG001|Outcome|Sham|Sham injection
10971065|NCT00913744|EG000|Reported Event|Ocriplasmin|Intravitreal injection (125 µg)
10971066|NCT00913744|EG001|Reported Event|Sham|Sham injection
10971067|NCT00913770|BG000|Baseline|Standard Care|Standard Care including receiving a referral.
10971068|NCT00913770|BG001|Baseline|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
10971069|NCT00913770|BG002|Baseline|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
10971070|NCT00913770|BG003|Baseline|Total|Total of all reporting groups
10971071|NCT00913770|FG000|Participant Flow|Standard Care|Standard Care including receiving a referral.
11293663|NCT02963376|OG003|Outcome|0.10 mL/kg Placebo|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293664|NCT02963376|OG004|Outcome|0.17 mL/kg DDFPe|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293665|NCT02963376|OG005|Outcome|0.17 mL/kg Placebo|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293666|NCT02963376|OG000|Outcome|Controls (n=6)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~All control patients are grouped for the NIHSS results."
11293667|NCT02963376|OG001|Outcome|DDFPe (n=18)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~This column groups the NIHSS results of all DDFPe treated patients."
11293668|NCT02963376|OG002|Outcome|0.05 mL/kg DDFPe|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293669|NCT02963376|OG003|Outcome|0.10 mL/kg DDFPe|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293670|NCT02963376|OG000|Outcome|Controls (n=6)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~All control patients are grouped for the mRS results."
11293671|NCT02963376|OG001|Outcome|DDFPe (n=18)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~This column groups the mRS results of all DDFPe treated patients."
11293672|NCT02963376|OG002|Outcome|0.05 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.05 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg)."
11293673|NCT02963376|OG003|Outcome|0.10 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.10 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg)."
11293674|NCT02963376|OG004|Outcome|0.17 mL/kg DDFPe|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~0.17 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg)."
11293675|NCT02963376|EG000|Reported Event|Controls (n=6)|"This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.~For this reason, all control subjects are grouped."
11293676|NCT02963376|EG001|Reported Event|DDFPe - 0.05 mL/kg (n=6)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293677|NCT02963376|EG002|Reported Event|DDFPe - 0.10 mL/kg (n=6)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293678|NCT02963376|EG003|Reported Event|DDFPe - 0.17 mL/kg|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293679|NCT02963376|EG004|Reported Event|DDFPe Total (n=18)|This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
11293680|NCT02963441|BG000|Baseline|Effective Analysis Population|All subjects with a reading center reference standard and AI output (population that is available for statistical analysis).
11293681|NCT02963441|FG000|Participant Flow|Intent to Screen Population|Prospective study participants
11293682|NCT02963441|OG000|Outcome|Analyzable Study Population|Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
11293683|NCT02963441|OG000|Outcome|Analyzable Study Population|Participants with the reading center results needed for study analysis.
11293684|NCT02963441|EG000|Reported Event|Enrolled Population|All study subjects enrolled into the clinical study.
11293685|NCT02963506|BG000|Baseline|Placebo|Participants received placebo during the 12 weeks Double-Blind Period.
11293686|NCT02963506|BG001|Baseline|BKZ 16 mg|Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
11293687|NCT02963506|BG002|Baseline|BKZ 64 mg|Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
11293688|NCT02963506|BG003|Baseline|BKZ 160 mg|Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
11293689|NCT02963506|BG004|Baseline|BKZ 320 mg|Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
11293690|NCT02963506|BG005|Baseline|Total Title|
11293691|NCT02963506|FG000|Participant Flow|Placebo|Participants received placebo during the 12 weeks Double-Blind Period.
11293692|NCT02963506|FG001|Participant Flow|BKZ 16 mg|Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
11293693|NCT02963506|FG002|Participant Flow|BKZ 64 mg|Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
11293694|NCT02963506|FG003|Participant Flow|BKZ 160 mg|Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
11293695|NCT02963506|FG004|Participant Flow|BKZ 320 mg|Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
11293696|NCT02963506|FG005|Participant Flow|Placebo - BKZ 160 mg|After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
11293697|NCT02963506|FG006|Participant Flow|Placebo - BKZ 320 mg|After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period
11293698|NCT02963506|FG007|Participant Flow|BKZ 16 mg - BKZ 160 mg|After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
11293699|NCT02963506|FG008|Participant Flow|BKZ 16 mg - BKZ 320 mg|After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
11293700|NCT02963506|FG009|Participant Flow|BKZ 64 mg - BKZ 160 mg|After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
11293701|NCT02963506|FG010|Participant Flow|BKZ 64 mg - BKZ 320 mg|After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
11293702|NCT02963506|FG011|Participant Flow|BKZ 160 mg - BKZ 160 mg|Participants randomized to bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period.
11293703|NCT02963506|FG012|Participant Flow|BKZ 320 mg - BKZ 320 mg|Participants randomized to bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.
11293704|NCT02963506|OG000|Outcome|Placebo (FAS)|Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11293705|NCT02963506|OG001|Outcome|BKZ 16 mg (FAS)|Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11293706|NCT02963506|OG002|Outcome|BKZ 64 mg (FAS)|Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11293707|NCT02963506|OG003|Outcome|BKZ 160 mg (FAS)|Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
11293708|NCT02963506|OG004|Outcome|BKZ 320 mg (FAS)|Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
11293709|NCT02963506|OG000|Outcome|Placebo (SS) - up to Wk 12|This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
11293710|NCT02963506|OG001|Outcome|BKZ 16 mg (SS) - up to Wk 12|This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11293711|NCT02963506|OG002|Outcome|BKZ 64 mg (SS) - up to Wk 12|This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11293712|NCT02963506|OG003|Outcome|BKZ 160 mg (SS) - up to Wk 73|This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
11293713|NCT02963506|OG004|Outcome|BKZ 320 mg (SS) - up to Wk 73|This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
11293714|NCT02963506|EG000|Reported Event|Placebo (SS) - up to Wk 12|This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
11293715|NCT02963506|EG001|Reported Event|BKZ 16 mg (SS) - up to Wk 12|This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11293716|NCT02963506|EG002|Reported Event|BKZ 64 mg (SS) - up to Wk 12|This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11293717|NCT02963506|EG003|Reported Event|BKZ 160 mg (SS) - up to Wk 73|This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
11293718|NCT02963506|EG004|Reported Event|BKZ 320 mg (SS) - up to Wk 73|This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
11293719|NCT02963597|BG000|Baseline|Group A|"Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.~AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provides non-invasive ventilatory support to treat patients with sleep-disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in the sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water."
11293720|NCT02963597|BG001|Baseline|Group B|"Standard medical therapy only.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293721|NCT02963597|BG002|Baseline|Total|Total of all reporting groups
11293722|NCT02963597|FG000|Participant Flow|Group A|"Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.~AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293723|NCT02963597|FG001|Participant Flow|Group B|"Standard medical therapy only.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293724|NCT02963597|OG000|Outcome|Group A|"Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.~AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293725|NCT02963597|OG001|Outcome|Group B|"Standard medical therapy only.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293726|NCT02963597|EG000|Reported Event|Group A|"Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.~AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293727|NCT02963597|EG001|Reported Event|Group B|"Standard medical therapy only.~Standard Medical Therapy: Standard medical therapy according to current guidelines."
11293728|NCT02963701|BG000|Baseline|Treatment Sequence 1 (T-R)|Treatment sequence (Test-Reference): The subjects were administered orally under fasting condition first with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet and then with Reference product: 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets). Treatments were separated by a washout period of at least 5 days.
10971072|NCT00913770|FG001|Participant Flow|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
11293729|NCT02963701|BG001|Baseline|Treatment Sequence 2 (R-T)|Treatment sequence (Reference-Test): The subjects were administered orally under fasting condition first with Reference product : 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets) and then with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet. Treatments were separated by a washout period of at least 5 days.
11293730|NCT02963701|BG002|Baseline|Total|Total of all reporting groups
11293731|NCT02963701|FG000|Participant Flow|Treatment Sequence 1 (T-R)|Treatment sequence (Test-Reference): The subjects were administered orally under fasting condition first with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet and then with Reference product: 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets). Treatments were separated by a washout period of at least 5 days.
11293732|NCT02963701|FG001|Participant Flow|Treatment Sequence 2 (R-T)|Treatment sequence (Reference-Test): The subjects were administered orally under fasting condition first with Reference product : 2 x RhinAdvil® (Ibuprofen 200 milligram and Pseudoephedrine-HCl 30 milligram fixed dose combination film coated tablets) and then with Test product: Ibuprofen 400 milligram and Pseudoephedrine-HCl 60 milligram fixed dose combination film coated tablet. Treatments were separated by a washout period of at least 5 days.
11293733|NCT02963701|OG000|Outcome|Reference Product (R)|Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
11293734|NCT02963701|OG001|Outcome|Test Product (T)|Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
11293735|NCT02963701|EG000|Reported Event|Reference Product (R)|Subjects were orally administered with RhinAdvil® (Ibuprofen 200 mg and Pseudoephedrine-HCl 30 mg fixed dose combination film coated tablet) (2 tablets)
11293736|NCT02963701|EG001|Reported Event|Test Product (T)|Subjects were orally administered with Ibuprofen 400 mg and Pseudoephedrine-HCl 60 mg fixed dose combination film coated tablet (1 tablet)
11293737|NCT02963922|BG000|Baseline|Liraglutide 3.0 mg|Participants received liraglutide once daily by subcutaneous injection irrespective of the timing of meals. Participants received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the maintenance dose of 3.0 mg was reached after 4 weeks. The treatment period was 56 weeks.
11293738|NCT02963922|BG001|Baseline|Placebo|Participants received matching placebo once daily by subcutaneous injection irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. The treatment period was 56 weeks.
11293739|NCT02963922|BG002|Baseline|Total|Total of all reporting groups
11293740|NCT02963922|FG000|Participant Flow|Liraglutide 3.0 mg|Participants received liraglutide once daily by subcutaneous injection irrespective of the timing of meals. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the maintenance dose of 3.0 mg was reached after 4 weeks. The treatment period was 56 weeks.
11293741|NCT02963922|FG001|Participant Flow|Placebo|Participants received matching placebo once daily by subcutaneous injection irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. The treatment period was 56 weeks.
11293742|NCT02963922|OG000|Outcome|Liraglutide 3.0 mg|Participants received liraglutide once daily by subcutaneous injection irrespective of the timing of meals. Participants received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the maintenance dose of 3.0 mg was reached after 4 weeks. The treatment period was 56 weeks.
11293743|NCT02963922|OG001|Outcome|Placebo|Participants received matching placebo once daily by subcutaneous injection irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. The treatment period was 56 weeks.
11293744|NCT02963922|EG000|Reported Event|Liraglutide 3.0 mg|Participants received liraglutide once daily by subcutaneous injection irrespective of the timing of meals. Participants received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the maintenance dose of 3.0 mg was reached after 4 weeks. The treatment period was 56 weeks.
11293745|NCT02963922|EG001|Reported Event|Placebo|Participants received matching placebo once daily by subcutaneous injection irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. The treatment period was 56 weeks.
11293746|NCT02963935|BG000|Baseline|Liraglutide 3.0 mg|Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
11293747|NCT02963935|BG001|Baseline|Placebo|Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
11293748|NCT02963935|BG002|Baseline|Total|Total of all reporting groups
11293749|NCT02963935|FG000|Participant Flow|Liraglutide 3.0 mg|Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
11293750|NCT02963935|FG001|Participant Flow|Placebo|Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
11293751|NCT02963935|OG000|Outcome|Liraglutide 3.0 mg|Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
11293752|NCT02963935|OG001|Outcome|Placebo|Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
11293753|NCT02963935|EG000|Reported Event|Lira 3.0 mg|Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
11293754|NCT02963935|EG001|Reported Event|Placebo|Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
11293755|NCT02963974|BG000|Baseline|Cochlear Implant|"Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss~Cochlear implant: Implantation"
11293756|NCT02963974|FG000|Participant Flow|Cochlear Implant|"Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss~Cochlear implant: Implantation"
11293757|NCT02963974|OG000|Outcome|Cochlear Implant|"Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss~Cochlear implant: Implantation"
11293758|NCT02963974|EG000|Reported Event|Cochlear Implant|"Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss~Cochlear implant: Implantation"
11293759|NCT02963987|BG000|Baseline|All Study Participants|All participants in the crossover trial of two interventions in two periods
11293760|NCT02963987|FG000|Participant Flow|100% Portion Size First, Then 150% Portion Size|100% Food and Beverage Portion Size in first period, then 150% Food and Beverage Portion Size in second period
11293761|NCT02963987|FG001|Participant Flow|150% Portion Size First, Then 100% Portion Size|150% Food and Beverage Portion Size in first period, then 100% Food and Beverage Portion Size in second period
11293762|NCT02963987|OG000|Outcome|100% Portion Size|100% Food and Beverage Portion Size (baseline portions)
11293763|NCT02963987|OG001|Outcome|150% Portion Size|150% Food and Beverage Portion Size (increased 50% from baseline portions)
11293764|NCT02963987|OG000|Outcome|100% Portion Size|"100% Food and Beverage Portion Size~Food and Beverage Portion Size: Variations of Food and Beverage Portion Size, 100% Baseline portions and increased 50% for 150% portions"
11293765|NCT02963987|OG001|Outcome|150% Portion Size|"150% Food and Beverage Portion Size~Food and Beverage Portion Size: Variations of Food and Beverage Portion Size, 100% Baseline portions and increased 50% for 150% portions"
11293766|NCT02963987|EG000|Reported Event|100% Portion Size|Study participants in the period in which they were served 100% portions of food and beverages. The total includes participants who were served some meals but whose data was excluded from analysis for low attendance.
11293767|NCT02963987|EG001|Reported Event|150% Portion Size|Study participants in the period in which they were served 150% portions of food and beverages. The total includes participants who were served some meals but whose data was excluded from analysis for low attendance.
11332581|NCT03497845|FG000|Participant Flow|a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332582|NCT03497845|FG001|Participant Flow|b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332583|NCT03497845|FG002|Participant Flow|c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332584|NCT03497845|FG003|Participant Flow|d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332585|NCT03497845|FG004|Participant Flow|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332586|NCT03497845|FG005|Participant Flow|f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332587|NCT03497845|FG006|Participant Flow|g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332588|NCT03497845|FG007|Participant Flow|h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332589|NCT03497845|FG008|Participant Flow|i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332590|NCT03497845|FG009|Participant Flow|j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332591|NCT03497845|FG010|Participant Flow|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332592|NCT03497845|FG011|Participant Flow|l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11293768|NCT02964234|BG000|Baseline|Empowerment|"Behavior: Empowerment~Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks"
10971073|NCT00913770|FG002|Participant Flow|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
10971074|NCT00913770|OG000|Outcome|Standard Care|Standard Care including receiving a referral.
10971075|NCT00913770|OG001|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
10971076|NCT00913770|OG002|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
10971077|NCT00913770|EG000|Reported Event|Standard Care|Standard Care including receiving a referral.
10971078|NCT00913770|EG001|Reported Event|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
10971079|NCT00913770|EG002|Reported Event|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
10971080|NCT00913835|BG000|Baseline|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
10971081|NCT00913835|BG001|Baseline|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
10971082|NCT00913835|BG002|Baseline|Total|Total of all reporting groups
10971083|NCT00913835|FG000|Participant Flow|Olaratumab + Liposomal Doxorubicin|"20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.~40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
10971084|NCT00913835|FG001|Participant Flow|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
10971085|NCT00913835|OG000|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
11293769|NCT02964234|BG001|Baseline|Education|"Behavior: Education~Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks"
11293770|NCT02964234|BG002|Baseline|Total|Total of all reporting groups
11293771|NCT02964234|FG000|Participant Flow|Empowerment|"Behavior: Empowerment~Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks"
11293772|NCT02964234|FG001|Participant Flow|Education|"Behavior: Education~Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks"
11293773|NCT02964234|OG000|Outcome|Empowerment|"Behavior: Empowerment~Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks"
11293774|NCT02964234|OG001|Outcome|Education|"Behavior: Education~Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks"
11293775|NCT02964234|EG000|Reported Event|Empowerment|"Behavior: Empowerment~Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks"
11293776|NCT02964234|EG001|Reported Event|Education|"Behavior: Education~Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks"
11293777|NCT02964247|BG000|Baseline|Liraglutide|"Eligible subjects were given liraglutide subcutaneously (s.c.), once daily (OD) for 26 weeks. Subjects received 0.6 mg dose of liraglutide in week 1, dose was escalated to 1.2 mg in week 2 and 1.8 mg in week 3. Subjects remained on the stable dose of 1.8 mg liraglutide from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293778|NCT02964247|BG001|Baseline|Placebo|"Eligible subjects were given liraglutide placebo subcutaneously (s.c.), once daily (OD) for 26 weeks. Dose escalation for placebo matched that for liraglutide with regards to volume. Subjects remained on the stable dose of 1.8 mg placebo from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose during the trial. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293779|NCT02964247|BG002|Baseline|Total|Total of all reporting groups
11293780|NCT02964247|FG000|Participant Flow|Liraglutide|"Eligible subjects were given liraglutide subcutaneously (s.c.), once daily (OD) for 26 weeks. Subjects received 0.6 mg dose of liraglutide in week 1, dose was escalated to 1.2 mg in week 2 and 1.8 mg in week 3. Subjects remained on the stable dose of 1.8 mg liraglutide from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293781|NCT02964247|FG001|Participant Flow|Placebo|"Eligible subjects were given liraglutide placebo subcutaneously (s.c.), once daily (OD) for 26 weeks. Dose escalation for placebo matched that for liraglutide with regards to volume. Subjects remained on the stable dose of 1.8 mg placebo from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose during the trial. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293782|NCT02964247|OG000|Outcome|Liraglutide|"Eligible subjects were given liraglutide subcutaneously (s.c.), once daily (OD) for 26 weeks. Subjects received 0.6 mg dose of liraglutide in week 1, dose was escalated to 1.2 mg in week 2 and 1.8 mg in week 3. Subjects remained on the stable dose of 1.8 mg liraglutide from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293783|NCT02964247|OG001|Outcome|Placebo|"Eligible subjects were given liraglutide placebo subcutaneously (s.c.), once daily (OD) for 26 weeks. Dose escalation for placebo matched that for liraglutide with regards to volume. Subjects remained on the stable dose of 1.8 mg placebo from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose during the trial. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293784|NCT02964247|EG000|Reported Event|Liraglutide|"Eligible subjects were given liraglutide subcutaneously (s.c.), once daily (OD) for 26 weeks. Subjects received 0.6 mg dose of liraglutide in week 1, dose was escalated to 1.2 mg in week 2 and 1.8 mg in week 3. Subjects remained on the stable dose of 1.8 mg liraglutide from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
10971086|NCT00913835|OG001|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
10971087|NCT00913835|OG001|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy.."
11293785|NCT02964247|EG001|Reported Event|Placebo|"Eligible subjects were given liraglutide placebo subcutaneously (s.c.), once daily (OD) for 26 weeks. Dose escalation for placebo matched that for liraglutide with regards to volume. Subjects remained on the stable dose of 1.8 mg placebo from week 3 to 26. Subjects continued their pre-trial SGLT2 inhibitor as monotherapy or in combination with metformin at stable pre-trial dose during the trial. Any one of three SGLT2 inhibitors were allowed as pre-trial therapy: Invokana®, Farxiga®/Forxiga® and Jardiance®. Stable pre-trial treatment with metformin was defined as ≥1500 mg/day or at the maximum tolerated dose. Any fixed dose combination of SGLT2 inhibitors and metformin was also allowed in this trial as background medication.~A follow-up visit was scheduled one week after the end of treatment."
11293786|NCT02964312|BG000|Baseline|Latera Implant|"Nasal Implant~Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure"
11293787|NCT02964312|FG000|Participant Flow|Latera Implant|"Nasal Implant~Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure"
11293788|NCT02964312|OG000|Outcome|Latera Implant|Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
11293789|NCT02964312|OG000|Outcome|Latera Implant|Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure
11293790|NCT02964312|OG000|Outcome|Latera Implant|"Nasal Implant~Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure"
11293791|NCT02964312|OG000|Outcome|Latera Implant|"Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.~Nasal Implant: Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia."
11293792|NCT02964312|EG000|Reported Event|Latera Implant|"Nasal Implant~Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure"
11293793|NCT02964325|BG000|Baseline|MIRASOL|"Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System~Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system."
11293794|NCT02964325|BG001|Baseline|CONTROL|"Randomized to leukoreduced, apheresis platelets stored in 100% plasma~Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs."
10971088|NCT00913835|OG002|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
11293795|NCT02964325|BG002|Baseline|Total|Total of all reporting groups
10971089|NCT00913835|OG001|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
11293796|NCT02964325|FG000|Participant Flow|MIRASOL|"Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System~Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system."
11293797|NCT02964325|FG001|Participant Flow|CONTROL|"Randomized to leukoreduced, apheresis platelets stored in 100% plasma~Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs."
11293798|NCT02964325|OG000|Outcome|MIRASOL|"Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System~Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system."
11293799|NCT02964325|OG001|Outcome|CONTROL|"Randomized to leukoreduced, apheresis platelets stored in 100% plasma~Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs."
11293800|NCT02964325|EG000|Reported Event|MIRASOL|"Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System~Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system."
11293801|NCT02964325|EG001|Reported Event|CONTROL|"Randomized to leukoreduced, apheresis platelets stored in 100% plasma~Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs."
11293802|NCT02964338|BG000|Baseline|Placebo|Participants received placebo via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injections at Weeks 4 and 8.
11293803|NCT02964338|BG001|Baseline|Fremanezumab 675/225/225 mg|Participants received placebo via an approximately 1-hour intravenous infusion and fremanezumab at 675 mg as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293804|NCT02964338|BG002|Baseline|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg via an approximately 1-hour intravenous infusion and placebo administered as 3 subcutaneous injections at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293805|NCT02964338|BG003|Baseline|Total|Total of all reporting groups
11293806|NCT02964338|FG000|Participant Flow|Placebo|Participants received placebo via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injections at Weeks 4 and 8.
11293807|NCT02964338|FG001|Participant Flow|Fremanezumab 675/225/225 mg|Participants received placebo via an approximately 1-hour intravenous infusion and fremanezumab at 675 mg as 3 subcutaneous injections (225 mg/1.5 milliliters [mL]) at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293808|NCT02964338|FG002|Participant Flow|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg via an approximately 1-hour intravenous infusion and placebo administered as 3 subcutaneous injections at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293809|NCT02964338|OG000|Outcome|Placebo|Participants received placebo via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injections at Weeks 4 and 8.
11293810|NCT02964338|OG001|Outcome|Fremanezumab 675/225/225 mg|Participants received placebo via an approximately 1-hour intravenous infusion and fremanezumab at 675 mg as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293811|NCT02964338|OG002|Outcome|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg via an approximately 1-hour intravenous infusion and placebo administered as 3 subcutaneous injections at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
10971090|NCT00913835|OG000|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
10971091|NCT00913835|OG001|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
10971092|NCT00913835|OG002|Outcome|Liposomal Doxorubicin: Optional Olaratumab Treatment|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
10971093|NCT00913835|EG000|Reported Event|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
10971094|NCT00913835|EG001|Reported Event|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
10971095|NCT00913835|EG002|Reported Event|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
11293812|NCT02964338|EG000|Reported Event|Placebo|Participants received placebo via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injections at Weeks 4 and 8.
11293813|NCT02964338|EG001|Reported Event|Fremanezumab 675/225/225 mg|Participants received placebo via an approximately 1-hour intravenous infusion and fremanezumab at 675 mg as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293814|NCT02964338|EG002|Reported Event|Fremanezumab 900/225/225 mg|Participants received fremanezumab at 900 mg via an approximately 1-hour intravenous infusion and placebo administered as 3 subcutaneous injections at Week 0 followed by fremanezumab at 225 mg administered as single subcutaneous injections (225 mg/1.5 mL) at Weeks 4 and 8.
11293815|NCT02964416|BG000|Baseline|Tramadol|Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure
11293816|NCT02964416|BG001|Baseline|Placebo|0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
11293817|NCT02964416|BG002|Baseline|Total|Total of all reporting groups
11293818|NCT02964416|FG000|Participant Flow|Tramadol|"Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure~Injection Tramadol"
11293819|NCT02964416|FG001|Participant Flow|Placebo|"0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure~placebo: 0.9% Normal saline in 10 ml syringe"
11293820|NCT02964416|OG000|Outcome|Tramadol|Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure
11293821|NCT02964416|OG001|Outcome|Placebo|0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
11293822|NCT02964416|OG000|Outcome|Tramadol|Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure
11293823|NCT02964416|EG000|Reported Event|Tramadol|Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure
11293824|NCT02964416|EG001|Reported Event|Placebo|0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
11293825|NCT02964767|BG000|Baseline|1.HIV|patients with mono HIV infections
11293826|NCT02964767|BG001|Baseline|2.HIV/Tb.|Patients with HIV/Tb. co infections
11293827|NCT02964767|BG002|Baseline|Total|Total of all reporting groups
11293828|NCT02964767|FG000|Participant Flow|HIV,|HIV mono infected patients,
11293829|NCT02964767|FG001|Participant Flow|HIV/Tb.|Patients with HIV/Tb. co infection
11293830|NCT02964767|OG000|Outcome|Prevalence of HIV/Tb. co Infection|Percentage of Tb. co infections among HIV patients enrolled at ART center.
11293831|NCT02964767|OG000|Outcome|1.HIV|HIV patients only
11293832|NCT02964767|OG001|Outcome|2.HIV/Tb.|Patients with HIV/Tb. co infections
11293833|NCT02964767|EG000|Reported Event|HIV,|HIV patients
11293834|NCT02964767|EG001|Reported Event|HIV/Tb. co Infections|Patients with HIV-Tb. co infections
11293835|NCT02964910|BG000|Baseline|the Chronic Hepatitis B Patients|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293836|NCT02964910|BG001|Baseline|the Healthy Volunteer|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293837|NCT02964910|BG002|Baseline|Total|Total of all reporting groups
11293838|NCT02964910|FG000|Participant Flow|the Chronic Hepatitis B Patients|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293839|NCT02964910|FG001|Participant Flow|the Healthy Volunteer|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293840|NCT02964910|OG000|Outcome|the Chronic Hepatitis B Patients|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293841|NCT02964910|OG001|Outcome|the Healthy Volunteer|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293842|NCT02964910|OG000|Outcome|the Chronic Hepatitis B Patients|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293843|NCT02964910|OG001|Outcome|the Healthy Volunteer|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293844|NCT02964910|EG000|Reported Event|the Chronic Hepatitis B Patients|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293845|NCT02964910|EG001|Reported Event|the Healthy Volunteer|"Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.~Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month."
11293846|NCT02965144|BG000|Baseline|HGG Patients|"single-group study- long term survivors~no treatment: no treatment"
11293847|NCT02965144|FG000|Participant Flow|HGG Patients|"single-group study- long term survivors~no treatment: no treatment"
11293848|NCT02965144|OG000|Outcome|HGG Patients|"single-group study- long term survivors~no treatment: no treatment Analysis of the interviews identified three main themes, shared by patients and their caregivers: (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons."
11293849|NCT02965144|OG000|Outcome|HGG Patients|single-group study- long term survivors
11293850|NCT02965144|OG000|Outcome|HGG Patients|"single-group study- long term survivors~no treatment: no treatment"
11293851|NCT02965144|OG000|Outcome|HGG Patients|"single-group study- long term survivors~no treatment: no treatment~Concerning depression, HADS showed moderate depressive symptoms in one patient (10%), and none of the patients reported having severe symptoms. Our data seem to be lower for anxiety (5.5±5.17) compared with the normative value (of 6.14±3.76), and higher for depression (4.15±4.0) compared with the normative value (of 3.68±3.07)."
11293852|NCT02965144|EG000|Reported Event|HGG Patients|"single-group study- long term survivors~no treatment: no treatment"
11293853|NCT02965378|BG000|Baseline|AZD4547|"Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11293854|NCT02965378|BG001|Baseline|Docetaxel|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to AZD4547.~Docetaxel Given IV~Other Names:~Docecad~Docetaxel~RP56976~Taxotere~Taxotere Injection Concentrate~Laboratory Biomarker Analysis: Correlative studies"
11293855|NCT02965378|BG002|Baseline|Total|Total of all reporting groups
11293856|NCT02965378|FG000|Participant Flow|AZD4547|"Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11293857|NCT02965378|FG001|Participant Flow|Docetaxel|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to AZD4547.~Docetaxel Given IV~Other Names:~Docecad~Docetaxel~RP56976~Taxotere~Taxotere Injection Concentrate~Laboratory Biomarker Analysis: Correlative studies"
11293858|NCT02965378|OG000|Outcome|Arm I - AZD4547|"Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11293859|NCT02965378|OG000|Outcome|AZD4547|"Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO~Laboratory Biomarker Analysis: Correlative studies"
11293860|NCT02965378|EG000|Reported Event|AZD4547|"Participants receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~FGFR Inhibitor AZD4547: Given PO Laboratory Biomarker Analysis: Correlative studies"
11293861|NCT02965378|EG001|Reported Event|Docetaxel|"Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, participants may be eligible to re-register to AZD4547.~Docetaxel: Given IV Other Names: Docecad Docetaxel RP56976 Taxotere Taxotere Injection Concentrate~Laboratory Biomarker Analysis: Correlative studies"
11293862|NCT02965456|BG000|Baseline|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293863|NCT02965456|BG001|Baseline|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293864|NCT02965456|BG002|Baseline|Total|Total of all reporting groups
11293865|NCT02965456|FG000|Participant Flow|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293866|NCT02965456|FG001|Participant Flow|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293867|NCT02965456|OG000|Outcome|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293868|NCT02965456|OG001|Outcome|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293869|NCT02965456|EG000|Reported Event|IDP-121 Lotion|IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
10971096|NCT00913913|BG000|Baseline|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
11293870|NCT02965456|EG001|Reported Event|IDP-121 Vehicle Lotion|IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
11293871|NCT02965534|BG000|Baseline|All Subjects|All subjects were included in Baseline and all investigations were obtained at these 100 subjects
11293872|NCT02965534|FG000|Participant Flow|Night Spectacle Correction - Photopic Spectacle Correction|"This arm has tested first the mesopic spectacle correction for 2 weeks and after this time the (standard) photopic spectacle correction for two weeks~Cross Over Design!"
11293873|NCT02965534|FG001|Participant Flow|Photopic Spectacle Correction - Night Spectacle Correction|"This arm has tested first the standard photopic spectacle correction for two weeks and after this time the mesopic spectacle correction for two weeks~Cross Over Design!"
11293874|NCT02965534|OG000|Outcome|All Subjects|
11293875|NCT02965534|OG000|Outcome|Night Spectacle Correction|"Refraction for this glasses was obtained at low luminance.~Spectacle/Glasses"
11293876|NCT02965534|OG001|Outcome|Spectacle Correction for Photopic Light Conditions|"Refraction for this glasses was obtained at high luminance level.~Spectacle/Glasses"
11293877|NCT02965534|EG000|Reported Event|Night Spectacle Correction|"Refraction for this glasses was obtained at low luminance.~Spectacle/Glasses"
11293878|NCT02965534|EG001|Reported Event|Spectacle Correction for Photopic Light Conditions|"Refraction for this glasses was obtained at high luminance level.~Spectacle/Glasses"
11293879|NCT02965573|BG000|Baseline|ARGX-113|Patients received ARGX-113 at a dose of 10 mg/kg in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293880|NCT02965573|BG001|Baseline|Placebo|Patients received matching placebo in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293881|NCT02965573|BG002|Baseline|Total|Total of all reporting groups
11293882|NCT02965573|FG000|Participant Flow|ARGX-113|Patients received ARGX-113 at a dose of 10 mg/kg in 4 intravenous (IV) infusions, administered 1 week apart, in addition to SoC.
11293883|NCT02965573|FG001|Participant Flow|Placebo|Patients received matching placebo in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293884|NCT02965573|OG000|Outcome|ARGX-113|Patients received ARGX-113 at a dose of 10 mg/kg in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293885|NCT02965573|OG001|Outcome|Placebo|Patients received matching placebo in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293886|NCT02965573|EG000|Reported Event|ARGX-113|Patients received ARGX-113 at a dose of 10 mg/kg in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293887|NCT02965573|EG001|Reported Event|Placebo|Patients received matching placebo in 4 IV infusions, administered 1 week apart, in addition to SoC.
11293888|NCT02965599|BG000|Baseline|Placebo|Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.
11293889|NCT02965599|BG001|Baseline|GSK3117391, 40 mg|Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
11293890|NCT02965599|BG002|Baseline|Total|Total of all reporting groups
11293891|NCT02965599|FG000|Participant Flow|Placebo|Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.
11293892|NCT02965599|FG001|Participant Flow|GSK3117391, 40 mg|Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
11293893|NCT02965599|OG000|Outcome|Placebo|Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.
11293894|NCT02965599|OG001|Outcome|GSK3117391, 40 mg|Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
11293895|NCT02965599|OG000|Outcome|GSK3339189|GSK3339189 is a metabolite of GSK3117391. Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
11293896|NCT02965599|EG000|Reported Event|Placebo|Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.
11293897|NCT02965599|EG001|Reported Event|GSK3117391, 40 mg|Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
11293898|NCT02965781|BG000|Baseline|One SADBE Application|"Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.~SADBE: Topical solution~Placebo: Topical solution"
11293899|NCT02965781|BG001|Baseline|Two SADBE Applications|"Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.~SADBE: Topical solution"
11293900|NCT02965781|BG002|Baseline|Placebo Application (DMSO Only-No SADBE)|"Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.~Placebo: Topical solution"
11293901|NCT02965781|BG003|Baseline|Total|Total of all reporting groups
11293902|NCT02965781|FG000|Participant Flow|One SADBE Application|"Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.~SADBE: Topical solution~Placebo: Topical solution"
11293903|NCT02965781|FG001|Participant Flow|Two SADBE Applications|"Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.~SADBE: Topical solution"
11293904|NCT02965781|FG002|Participant Flow|Placebo Application (DMSO Only-No SADBE)|"Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.~Placebo: Topical solution"
11293905|NCT02965781|OG000|Outcome|Placebo Application (DMSO Only-No SADBE)|Placebo
11293906|NCT02965781|OG001|Outcome|Two SADBE Applications|2-dose
11293907|NCT02965781|OG002|Outcome|One SADBE Application|1-dose
11293908|NCT02965781|EG000|Reported Event|Placebo Application (DMSO Only-No SADBE)|Placebo
11293909|NCT02965781|EG001|Reported Event|Two SADBE Applications|2-dose
11293910|NCT02965781|EG002|Reported Event|One SADBE Application|1-dose
11293911|NCT02965820|BG000|Baseline|Overall|OFPM and HMPS used during Period 1 and Period 2 in a crossover assignment.
11293912|NCT02965820|FG000|Participant Flow|OFPM/HMPS|OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293913|NCT02965820|FG001|Participant Flow|HMPS/OFPM|Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293914|NCT02965820|OG000|Outcome|OFPM|OPTI-FREE® PureMoist® multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293915|NCT02965820|OG001|Outcome|HMPS|Subject's habitual multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293916|NCT02965820|EG000|Reported Event|OFPM|All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution
11293917|NCT02965820|EG001|Reported Event|HMPS|All subjects exposed to habitual multi-purpose contact lens solution
11293918|NCT02965833|BG000|Baseline|Overall|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix and subject's HMPS used during Period 1 and Period 2 in a crossover assignment.
11293919|NCT02965833|FG000|Participant Flow|CCP/HMPS|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution (CCP) in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293920|NCT02965833|FG001|Participant Flow|HMPS/CCP|Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293921|NCT02965833|OG000|Outcome|CLEAR CARE PLUS|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293922|NCT02965833|OG001|Outcome|HMPS|Subject's habitual multi-purpose contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
11293923|NCT02965833|EG000|Reported Event|CLEAR CARE PLUS|All subjects exposed to CCP contact lens solution
11293924|NCT02965833|EG001|Reported Event|HMPS|All subjects exposed to habitual multi-purpose contact lens solution
11293925|NCT02965924|BG000|Baseline|Phenylephrine|"Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.~Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop"
11293926|NCT02965924|FG000|Participant Flow|Phenylephrine|"Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.~Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop"
11293927|NCT02965924|OG000|Outcome|Phenylephrine|"Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.~Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop"
11293928|NCT02965924|EG000|Reported Event|Phenylephrine|"Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.~Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop"
11293929|NCT02965989|BG000|Baseline|Online Training of a Nursing Technique|"Participants receives an individual online training of extraction of blood culture for 3 months (This platform aims to improve knowledge and skills), they are sent 3 homework (one per month) and are evaluated at the end of each.~Online training of a nursing technique: The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual."
11293930|NCT02965989|BG001|Baseline|Not Receive Online Training|Participants don´t receives an individual online training of extraction of blood culture.Do their work as usual.
11293931|NCT02965989|BG002|Baseline|Total|Total of all reporting groups
11293932|NCT02965989|FG000|Participant Flow|Online Training of a Nursing Technique|"Participants receives an individual online training of extraction of blood culture for 3 months (This platform aims to improve knowledge and skills), they are sent 3 homework (one per month) and are evaluated at the end of each.~Online training of a nursing technique: The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual."
11293933|NCT02965989|FG001|Participant Flow|Not Receive Online Training|Participants don´t receives an individual online training of extraction of blood culture. Do their work as usual.
11293934|NCT02965989|OG000|Outcome|Online Training of a Nursing Technique Before Intervention.|"Participants perform the technique of blood culture extraction in a conventional way. After 6 months of monitoring of contaminated blood cultures, this group will receive online training to improve the performance of this technique.~Report of month 6 (amount of the first 6 months)."
11293935|NCT02965989|OG001|Outcome|Not Received Online Training Before Intervention.|"Participants perform the technique of blood culture extraction in a conventional way. This group will not receives an individual online training of extraction of blood culture in any time during the study. Perform the technique as usual way.~Report of month 6 (amount of the first 6 months)."
11293936|NCT02965989|OG002|Outcome|Online Training of a Nursing Technique After Intervention.|"Participants receives an individual online training of extraction of blood culture for 3 months (This platform aims to improve knowledge and skills), they are sent 3 homework (one per month) and are evaluated at the end of each.~Online training of a nursing technique: The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm (Not receive online training after intervention) They will not receive any training. They work as usual.~Report of month 9 (amount between the 6 to 9 months)."
11293937|NCT02965989|OG003|Outcome|Not Received Online Training After Intervention.|"Participants don´t receives an individual online training of extraction of blood culture.Do their work as usual.~Report of month 9 (amount between the 6 to 9 months)."
11293938|NCT02965989|OG000|Outcome|Online Training of a Nursing Technique Before Intervention.|Participants don´t receives any added knowledge or training in the 6 month before intervention. Maintain a regular training within their professional recycling. Those professionals were avaluated before starting the intervention for to know the previous level of Knowledge.
11293939|NCT02965989|OG001|Outcome|Not Received Online Training Before Intervention.|Participants don´t receives an individual online training of extraction of blood culture.Do their work as usual. Maintain a regular training within their professional recycling. Those professionals were avaluated before starting the intervention for to know the previous level of Knowledge.
11293940|NCT02965989|OG002|Outcome|Online Training of a Nursing Technique After Intervention.|"Participants receives an individual online training of extraction of blood culture for 3 months (This platform aims to improve knowledge and skills), they are sent 3 homework (one per month) and are evaluated at the end of each.~Online training of a nursing technique: The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual.~Those professionals were evaluated after finished the intervention for to know the level of Knowledge."
11293941|NCT02965989|OG003|Outcome|Not Received Online Training After Intervention.|"Participants don´t receives an individual online training of extraction of blood culture.Do their work as usual.Maintain a regular training within their professional recycling.~Those professionals were evaluated after finished the intervention for to know the level of Knowledge."
11293942|NCT02965989|EG000|Reported Event|Online Training of a Nursing Technique|"Participants receives an individual online training of extraction of blood culture for 3 months (This platform aims to improve knowledge and skills), they are sent 3 homework (one per month) and are evaluated at the end of each.~Online training of a nursing technique: The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual."
11293943|NCT02965989|EG001|Reported Event|Not Receive Online Training|Participants don´t receives an individual online training of extraction of blood culture. Do their work as usual.
11293944|NCT02966002|BG000|Baseline|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
11293945|NCT02966002|FG000|Participant Flow|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
11293946|NCT02966002|OG000|Outcome|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
11293947|NCT02966002|EG000|Reported Event|Intervention: Aspirin|"650 mg. Twice a day for 8 weeks~Aspirin"
11293948|NCT02966015|BG000|Baseline|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
11293949|NCT02966015|BG001|Baseline|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
11293950|NCT02966015|BG002|Baseline|Total|Total of all reporting groups
11293951|NCT02966015|FG000|Participant Flow|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
11293952|NCT02966015|FG001|Participant Flow|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
11293953|NCT02966015|OG000|Outcome|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
11293954|NCT02966015|OG001|Outcome|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
11293955|NCT02966015|EG000|Reported Event|Tiemann/Coudé Users|"The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.~Coloplast test catheter: This is a newly developed catheter"
11293956|NCT02966015|EG001|Reported Event|Traditional Sleeve Catheter Users|The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
11293957|NCT02966028|BG000|Baseline|SNF472 300 mg|"Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293958|NCT02966028|BG001|Baseline|SNF 472 600 mg|"Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293959|NCT02966028|BG002|Baseline|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293960|NCT02966028|BG003|Baseline|Total|Total of all reporting groups
11293961|NCT02966028|FG000|Participant Flow|SNF472 300 mg|"Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293962|NCT02966028|FG001|Participant Flow|SNF 472 600 mg|"Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293963|NCT02966028|FG002|Participant Flow|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293964|NCT02966028|OG000|Outcome|SNF472 300 mg & 600 mg Combined|"Dose (300 mg or 600 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) or 2 vials of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293965|NCT02966028|OG001|Outcome|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293966|NCT02966028|OG000|Outcome|SNF472 300 mg|"Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293967|NCT02966028|OG001|Outcome|SNF 472 600 mg|"Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293968|NCT02966028|OG002|Outcome|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293969|NCT02966028|OG002|Outcome|SNF 472 Combined Dose Groups|"Doses 300 and 600 mg. 1 vial of physiological saline and 1 vial of active or 2 vials of active(10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293970|NCT02966028|OG003|Outcome|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293971|NCT02966028|EG000|Reported Event|SNF472 300 mg|"Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293972|NCT02966028|EG001|Reported Event|SNF 472 600 mg|"Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)~SNF472: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293973|NCT02966028|EG002|Reported Event|Matching Placebo|"Placebo arm: 2 vials of physiological saline~Placebo: Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions."
11293974|NCT02966275|BG000|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with either glucagon or placebo (randomized, double blinded allocation for each day) for 14 days.~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon or placebo based on the signal from a minimally invasive continuous glucose monitor."
11293975|NCT02966275|FG000|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Participants would be on glucagon or placebo for either 1 day or 2 days and then switch to the alternate arm. They could not be on the same arm for more than 2 days in a row.~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11293976|NCT02966275|OG000|Outcome|Glucagon-only Bionic Pancreas - Glucagon|"Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set.~Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.~Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11293977|NCT02966275|OG001|Outcome|Glucagon-only Bionic Pancreas - Placebo|"Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set.~Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.~Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor."
11293978|NCT02966275|OG000|Outcome|All Randomized Participants|All participants that were randomized and began participation in the trial
11293979|NCT02966275|EG000|Reported Event|Glucagon-only Bionic Pancreas - Glucagon|"Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set.~Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.~Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
11293980|NCT02966275|EG001|Reported Event|Glucagon-only Bionic Pancreas - Placebo|"Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set.~Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.~Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor."
11293981|NCT02966314|BG000|Baseline|Placebo|"Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.~Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months."
11293982|NCT02966314|BG001|Baseline|Omalizumab|"Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.~Omalizumab: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections."
11293983|NCT02966314|BG002|Baseline|Total|Total of all reporting groups
11293984|NCT02966314|FG000|Participant Flow|Placebo|"Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.~Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months."
11293985|NCT02966314|FG001|Participant Flow|Omalizumab|"Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.~Omalizumab: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections."
11293986|NCT02966314|OG000|Outcome|Placebo|"Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.~Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months."
11293987|NCT02966314|OG001|Outcome|Omalizumab|"Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.~Omalizumab: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections."
11293988|NCT02966314|EG000|Reported Event|Placebo|"Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.~Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months."
11293989|NCT02966314|EG001|Reported Event|Omalizumab|"Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.~Omalizumab: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections."
11293990|NCT02966340|BG000|Baseline|All Participants Who Completed the Study|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Results are to be reported by treatment (placebo vs prazosin) each of which include results for all participants. Therefore we report baseline characteristics for the entire group."
11293991|NCT02966340|FG000|Participant Flow|Prazosin 1st Visit, Placebo 2nd Visit|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293992|NCT02966340|FG001|Participant Flow|Placebo 1st Visit, Prazosin 2nd Visit|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293993|NCT02966340|OG000|Outcome|Prazosin 2mg Trials|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293994|NCT02966340|OG001|Outcome|Placebo Trials|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293995|NCT02966340|EG000|Reported Event|Prazosin 2mg Trials|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293996|NCT02966340|EG001|Reported Event|Placebo Trials|"All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).~Prazosin: 2mg Prazosin~Placebo: Placebo"
11293997|NCT02966353|BG000|Baseline|All Subjects|10 mg BID (2 tablets of 5mg) was self-administered as starting dose for all patients. This dose was maintained for the first 12 weeks and titrated up thereafter unless they had met criteria for dose hold or dose reduction. Dose was to have been increased or decreased per standardized dosing paradigm and not to have exceeded 25 mg bid.
11293998|NCT02966353|FG000|Participant Flow|All Subjects|10 mg BID (2 tablets of 5mg) was self-administered as starting dose for all patients. This dose was maintained for the first 12 weeks and titrated up thereafter unless they had met criteria for dose hold or dose reduction. Dose was to have been increased or decreased per standardized dosing paradigm and not to have exceeded 25 mg bid.
11293999|NCT02966353|OG000|Outcome|All Subjects|10 mg BID (2 tablets of 5mg) was self-administered as starting dose for all patients. This dose was maintained for the first 12 weeks and titrated up thereafter unless they had met criteria for dose hold or dose reduction. Dose was to have been increased or decreased per standardized dosing paradigm and not to have exceeded 25 mg bid.
11294000|NCT02966353|EG000|Reported Event|All Patients|10 mg BID (2 tablets of 5mg) was self-administered as starting dose for all patients. This dose was maintained for the first 12 weeks and titrated up thereafter unless they had met criteria for dose hold or dose reduction. Dose was to have been increased or decreased per standardized dosing paradigm and not to have exceeded 25 mg bid.
11294001|NCT02966509|BG000|Baseline|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
11294002|NCT02966509|BG001|Baseline|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
11294003|NCT02966509|BG002|Baseline|Total|Total of all reporting groups
11294004|NCT02966509|FG000|Participant Flow|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
11294005|NCT02966509|FG001|Participant Flow|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
11294006|NCT02966509|OG000|Outcome|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
11294007|NCT02966509|OG001|Outcome|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
11294008|NCT02966509|EG000|Reported Event|A: Intervention Arm|"All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.~EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study."
11294009|NCT02966509|EG001|Reported Event|B: Control Group Arm|All participants randomized to Arm B will receive usual oncologic care.
11294010|NCT02966795|BG000|Baseline|Genotype 5-infected|Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294011|NCT02966795|BG001|Baseline|Genotype 6-infected|Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294012|NCT02966795|BG002|Baseline|Total|Total of all reporting groups
11294013|NCT02966795|FG000|Participant Flow|Genotype 5-infected|Participants with HCV genotype 5 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294014|NCT02966795|FG001|Participant Flow|Genotype 6-infected|Participants with HCV genotype 6 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294015|NCT02966795|OG000|Outcome|Genotype 5-infected|Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294016|NCT02966795|OG001|Outcome|Genotype 6-infected|Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
11294017|NCT02966795|EG000|Reported Event|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks.
11294018|NCT02966834|BG000|Baseline|Placebo|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.
11294019|NCT02966834|BG001|Baseline|GSK2330672 20 mg QD|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294020|NCT02966834|BG002|Baseline|GSK2330672 90 mg QD|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294021|NCT02966834|BG003|Baseline|GSK2330672 180 mg QD|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294022|NCT02966834|BG004|Baseline|GSK2330672 40 mg BID|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294023|NCT02966834|BG005|Baseline|GSK2330672 90 mg BID|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
11294024|NCT02966834|BG006|Baseline|Total|Total of all reporting groups
11294025|NCT02966834|FG000|Participant Flow|Placebo|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.
10848229|NCT00289185|OG000|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
11294026|NCT02966834|FG001|Participant Flow|GSK2330672 20 mg QD|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294027|NCT02966834|FG002|Participant Flow|GSK2330672 90 mg QD|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294028|NCT02966834|FG003|Participant Flow|GSK2330672 180 mg QD|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294029|NCT02966834|FG004|Participant Flow|GSK2330672 40 mg BID|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294030|NCT02966834|FG005|Participant Flow|GSK2330672 90 mg BID|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
11294031|NCT02966834|OG000|Outcome|Placebo|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.
11294032|NCT02966834|OG001|Outcome|GSK2330672 20 mg QD|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294033|NCT02966834|OG002|Outcome|GSK2330672 90 mg QD|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route
11294034|NCT02966834|OG003|Outcome|GSK2330672 180 mg QD|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294035|NCT02966834|OG004|Outcome|GSK2330672 40 mg BID|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294036|NCT02966834|OG005|Outcome|GSK2330672 90 mg BID|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
11294037|NCT02966834|OG000|Outcome|Placebo -Main Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.
11294038|NCT02966834|OG001|Outcome|GSK2330672 20 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.
11294039|NCT02966834|OG002|Outcome|GSK2330672 90 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.
11294040|NCT02966834|OG003|Outcome|GSK2330672 180 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.
11294041|NCT02966834|OG004|Outcome|GSK2330672 40 mg BID - Main Study Period|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.
11294042|NCT02966834|OG005|Outcome|GSK2330672 90 mg BID - Main Study Period|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.
11294043|NCT02966834|OG000|Outcome|Placebo - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.
11294044|NCT02966834|OG001|Outcome|GSK2330672 20 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.
11294045|NCT02966834|OG002|Outcome|GSK2330672 90 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.
11294046|NCT02966834|OG003|Outcome|GSK2330672 180 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.
11294047|NCT02966834|OG004|Outcome|GSK2330672 40 mg BID - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.
11294048|NCT02966834|OG005|Outcome|GSK2330672 90 mg BID - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.
11294049|NCT02966834|OG000|Outcome|Placebo - Follow-up|Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294050|NCT02966834|OG001|Outcome|GSK2330672 20 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294051|NCT02966834|OG002|Outcome|GSK2330672 90 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294052|NCT02966834|OG003|Outcome|GSK2330672 180 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294053|NCT02966834|OG004|Outcome|GSK2330672 40 mg BID - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294054|NCT02966834|OG005|Outcome|GSK2330672 90 mg BID - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294055|NCT02966834|OG000|Outcome|GSK2330672 20 mg QD|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294056|NCT02966834|OG001|Outcome|GSK2330672 90 mg QD|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route
11294057|NCT02966834|OG002|Outcome|GSK2330672 180 mg QD|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11294058|NCT02966834|OG003|Outcome|GSK2330672 40 mg BID|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.
11216464|NCT02307552|EG000|Reported Event|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.~UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
11216465|NCT02307682|BG000|Baseline|Brolucizumab 3 mg|Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11216466|NCT02307682|BG001|Baseline|Brolucizumab 6 mg|Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
11216467|NCT02307682|BG002|Baseline|Aflibercept 2 mg|Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11216468|NCT02307682|BG003|Baseline|Total|Total of all reporting groups
11216469|NCT02307682|FG000|Participant Flow|Brolucizumab 3 mg|Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11216470|NCT02307682|FG001|Participant Flow|Brolucizumab 6 mg|Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
11216471|NCT02307682|FG002|Participant Flow|Aflibercept 2 mg|Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11216472|NCT02307682|OG000|Outcome|Brolucizumab 3 mg|Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
11216473|NCT02307682|OG001|Outcome|Brolucizumab 6 mg|Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
11216474|NCT02307682|OG002|Outcome|Aflibercept 2 mg|Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
11216475|NCT02307682|EG000|Reported Event|Brolucizumab 3mg|All subjects exposed to brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose
11216476|NCT02307682|EG001|Reported Event|Brolucizumab 6mg|All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose
11216477|NCT02307682|EG002|Reported Event|Aflibercept 2mg|All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose
11216478|NCT02307838|BG000|Baseline|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
11216479|NCT02307838|BG001|Baseline|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
11216480|NCT02307838|BG002|Baseline|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
11216481|NCT02307838|BG003|Baseline|Total|Total of all reporting groups
11216482|NCT02307838|FG000|Participant Flow|FTY720 5.0 mg|In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.
11216483|NCT02307838|FG001|Participant Flow|FTY720 1.25 mg|In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.
11216484|NCT02307838|FG002|Participant Flow|Placebo|In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
11216485|NCT02307838|OG000|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
11216486|NCT02307838|OG001|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
11216487|NCT02307838|OG001|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
11216488|NCT02307838|OG002|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
11216489|NCT02307838|EG000|Reported Event|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
11216490|NCT02307838|EG001|Reported Event|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years.
11216491|NCT02307838|EG002|Reported Event|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
11216492|NCT02307916|BG000|Baseline|FGF-2|"FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~FGF-2: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery."
11216493|NCT02307916|BG001|Baseline|Placebo|"Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~Placebo: Placebo comparator using a sterile saline solution."
11216494|NCT02307916|BG002|Baseline|Total|Total of all reporting groups
11294059|NCT02966834|OG004|Outcome|GSK2330672 90 mg BID|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
11294060|NCT02966834|EG000|Reported Event|Placebo - Main Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.
11294061|NCT02966834|EG001|Reported Event|GSK2330672 20 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.
11294062|NCT02966834|EG002|Reported Event|GSK2330672 90 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.
11294063|NCT02966834|EG003|Reported Event|GSK2330672 180 mg QD - Main Study Period|Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.
11294064|NCT02966834|EG004|Reported Event|GSK2330672 40 mg BID - Main Study Period|Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.
11294065|NCT02966834|EG005|Reported Event|GSK2330672 90 mg BID - Main Study Period|Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.
11294066|NCT02966834|EG006|Reported Event|Placebo - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.
11294067|NCT02966834|EG007|Reported Event|GSK2330672 20 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.
11294068|NCT02966834|EG008|Reported Event|GSK2330672 90 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.
11294069|NCT02966834|EG009|Reported Event|GSK2330672 180 mg QD - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.
11294070|NCT02966834|EG010|Reported Event|GSK2330672 40 mg BID - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.
11294071|NCT02966834|EG011|Reported Event|GSK2330672 90 mg BID - Final Study Period|Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.
11294072|NCT02966834|EG012|Reported Event|Placebo - Follow-up|Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294073|NCT02966834|EG013|Reported Event|GSK2330672 20 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294074|NCT02966834|EG014|Reported Event|GSK2330672 90 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294075|NCT02966834|EG015|Reported Event|GSK2330672 180 mg QD - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294076|NCT02966834|EG016|Reported Event|GSK2330672 40 mg BID - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294077|NCT02966834|EG017|Reported Event|GSK2330672 90 mg BID - Follow-up|Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
11294078|NCT02967016|BG000|Baseline|Cesarean Delivery|Patients delivered via cesarean section
11294079|NCT02967016|BG001|Baseline|Vaginal Delivery|Patients delivery via cesarean delivery
11294080|NCT02967016|BG002|Baseline|Total|Total of all reporting groups
11294081|NCT02967016|FG000|Participant Flow|Normal Spontaneous Vaginal Delivery|"Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).~Actigraph: following delivery a ActiGraph will be offered to patients to track their steps"
11294082|NCT02967016|FG001|Participant Flow|Cesarean Delivery|"Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).~Actigraph: following delivery a ActiGraph will be offered to patients to track their steps"
11294083|NCT02967016|OG000|Outcome|Cesarean Delivery|Patients delivered via cesarean section
11294084|NCT02967016|OG001|Outcome|Vaginal Delivery|Patients delivery via cesarean delivery
11294085|NCT02967016|EG000|Reported Event|Normal Spontaneous Vaginal Delivery|"Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).~Actigraph: following delivery a ActiGraph will be offered to patients to track their steps"
11294086|NCT02967016|EG001|Reported Event|Cesarean Delivery|"Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).~Actigraph: following delivery a ActiGraph will be offered to patients to track their steps"
11294087|NCT02967055|BG000|Baseline|Enrolled Participants|Participants meeting all inclusion/exclusion criteria and enrolled into the study
11294088|NCT02967055|FG000|Participant Flow|Enrolled Participants|Participants meeting all inclusion/exclusion criteria and enrolled into the study
11294089|NCT02967055|OG000|Outcome|Enrolled Participants|Participants meeting all inclusion/exclusion criteria and enrolled into the study
11294090|NCT02967055|EG000|Reported Event|Enrolled Participants|Participants meeting all inclusion/exclusion criteria and enrolled into the study
11294091|NCT02967354|BG000|Baseline|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294092|NCT02967354|BG001|Baseline|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294093|NCT02967354|BG002|Baseline|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294094|NCT02967354|BG003|Baseline|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294095|NCT02967354|BG004|Baseline|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294096|NCT02967354|BG005|Baseline|Total|Total of all reporting groups
11294097|NCT02967354|FG000|Participant Flow|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294098|NCT02967354|FG001|Participant Flow|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294099|NCT02967354|FG002|Participant Flow|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294100|NCT02967354|FG003|Participant Flow|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294101|NCT02967354|FG004|Participant Flow|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294102|NCT02967354|OG000|Outcome|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294103|NCT02967354|OG001|Outcome|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294104|NCT02967354|OG002|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294105|NCT02967354|OG003|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294106|NCT02967354|OG004|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294107|NCT02967354|OG000|Outcome|Healthy Control|Healthy control.
11294108|NCT02967354|OG001|Outcome|Obese With Oral Antidiabetic Drugs|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
11294109|NCT02967354|OG002|Outcome|Obese, Treated With Oral Antidiabetic Drugs + Insulin|BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
11294110|NCT02967354|OG003|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
11294111|NCT02967354|OG004|Outcome|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
11294112|NCT02967354|EG000|Reported Event|Healthy Control|"Healthy control~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294113|NCT02967354|EG001|Reported Event|Obese With Oral Antidiabetic Drugs|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294114|NCT02967354|EG002|Reported Event|Obese, Treated With Oral Antidiabetic Drugs + Insulin|"BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294115|NCT02967354|EG003|Reported Event|Normal Weight, Treated With Oral Antidiabetic Drugs|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294116|NCT02967354|EG004|Reported Event|Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin|"BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin~Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan"
11294117|NCT02967367|BG000|Baseline|Jawbone/Withings Sleep Trackers, Bodymedia Sensewear|"2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients~Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient"
11294118|NCT02967367|FG000|Participant Flow|Jawbone/Withings Sleep Trackers, Bodymedia Sensewear|"2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients~Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient"
11294119|NCT02967367|OG000|Outcome|Jawbone/Withings Sleep Trackers, Bodymedia Sensewear|"2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients~Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient"
11294120|NCT02967367|EG000|Reported Event|Jawbone/Withings Sleep Trackers, Bodymedia Sensewear|"2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients~Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient~BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient"
11294121|NCT02967393|BG000|Baseline|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
11294122|NCT02967393|BG001|Baseline|IIV4|"0.5 mL intramuscular injection~IIV4"
11294123|NCT02967393|BG002|Baseline|Total|Total of all reporting groups
11294124|NCT02967393|FG000|Participant Flow|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
11294125|NCT02967393|FG001|Participant Flow|IIV4|"0.5 mL intramuscular injection~IIV4"
11294126|NCT02967393|OG000|Outcome|All Parents|Parents of participants from both arms
11294127|NCT02967393|OG000|Outcome|All Participants|Participants from both arms
11294128|NCT02967393|OG000|Outcome|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
11294129|NCT02967393|OG001|Outcome|IIV4|"0.5 mL intramuscular injection~IIV4"
11294130|NCT02967393|EG000|Reported Event|ccIIV4|"0.5 mL intramuscular injection~ccIIV4"
11294131|NCT02967393|EG001|Reported Event|IIV4|"0.5 mL intramuscular injection~IIV4"
11294132|NCT02967458|BG000|Baseline|Prostate Biopsy Patients|Fifty patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.
11294133|NCT02967458|FG000|Participant Flow|Prostate Biopsy Patients|Fifty five patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.
11294134|NCT02967458|OG000|Outcome|1Prostate Biopsy Patients|"Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging~Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used"
10848230|NCT00289185|OG001|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
11216495|NCT02307916|FG000|Participant Flow|FGF-2|"FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~FGF-2: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery."
11216496|NCT02307916|FG001|Participant Flow|Placebo|"Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~Placebo: Placebo comparator using a sterile saline solution."
11216497|NCT02307916|OG000|Outcome|FGF-2|"FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~FGF-2: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery."
11216498|NCT02307916|OG001|Outcome|Placebo|"Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~Placebo: Placebo comparator using a sterile saline solution."
11216499|NCT02307916|EG000|Reported Event|FGF-2|"FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~FGF-2: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery."
11216500|NCT02307916|EG001|Reported Event|Placebo|"Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.~Placebo: Placebo comparator using a sterile saline solution."
11216501|NCT02308007|BG000|Baseline|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216502|NCT02308007|BG001|Baseline|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216503|NCT02308007|BG002|Baseline|Terconazole/Metronidazole Vaginal Gel|"One applicator full at bedtime~Terconazole/metronidazole"
11216504|NCT02308007|BG003|Baseline|Total|Total of all reporting groups
11216505|NCT02308007|FG000|Participant Flow|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216506|NCT02308007|FG001|Participant Flow|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216507|NCT02308007|FG002|Participant Flow|Terconazole/Metronidazole Vaginal Gel|"One applicator full at bedtime~Terconazole/metronidazole"
11216508|NCT02308007|OG000|Outcome|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216509|NCT02308007|OG001|Outcome|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216510|NCT02308007|OG002|Outcome|Terconazole/Metronidazole Vaginal Gel|"One applicator full at bedtime~Terconazole/metronidazole"
11216511|NCT02308007|EG000|Reported Event|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216512|NCT02308007|EG001|Reported Event|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216513|NCT02308007|EG002|Reported Event|Terconazole/Metronidazole Vaginal Gel|"One applicator full at bedtime~Terconazole/metronidazole"
11216514|NCT02308020|BG000|Baseline|Part A Abemaciclib: HR+, HER2+ Breast Cancer|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216515|NCT02308020|BG001|Baseline|Part B Abemaciclib: HR+, HER2- Breast Cancer|"Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).~Participants may continue to receive treatment until discontinuation criteria are met."
11216516|NCT02308020|BG002|Baseline|Part C Abemaciclib: Surgical Resection|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours for 5-14 days prior to surgical resection. Dosing may resume following wound healing on a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216517|NCT02308020|BG003|Baseline|Part D Abemaciclib: NSCLC|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216518|NCT02308020|BG004|Baseline|Part E Abemaciclib: Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216519|NCT02308020|BG005|Baseline|Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216520|NCT02308020|BG006|Baseline|Total|Total of all reporting groups
11294135|NCT02967458|OG000|Outcome|Prostate Biopsy Patients|"Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging.~Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used"
11294136|NCT02967458|EG000|Reported Event|Prostate Biopsy Patients|"Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.~Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used"
11294137|NCT02967510|BG000|Baseline|Estriol 0.005%|Subjects received 1 gram of Estriol 0.005% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294138|NCT02967510|BG001|Baseline|Estriol 0.002%|Subjects received 1 gram of Estriol 0.002% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294139|NCT02967510|BG002|Baseline|Estriol 0.0008%|Subjects received 1 gram of Estriol 0.0008% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294140|NCT02967510|BG003|Baseline|Placebo|Subjects received 1 gram of matching placebo vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294141|NCT02967510|BG004|Baseline|Total|Total of all reporting groups
11294142|NCT02967510|FG000|Participant Flow|Estriol 0.005%|Subjects received 1 gram of Estriol 0.005% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294143|NCT02967510|FG001|Participant Flow|Estriol 0.002%|Subjects received 1 gram of Estriol 0.002% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294144|NCT02967510|FG002|Participant Flow|Estriol 0.0008%|Subjects received 1 gram of Estriol 0.0008% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294145|NCT02967510|FG003|Participant Flow|Placebo|Subjects received 1 gram of matching placebo vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294146|NCT02967510|OG000|Outcome|Estriol 0.005%|Subjects received 1 gram of Estriol 0.005% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294147|NCT02967510|OG001|Outcome|Estriol 0.002%|Subjects received 1 gram of Estriol 0.002% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294148|NCT02967510|OG002|Outcome|Estriol 0.0008%|Subjects received 1 gram of Estriol 0.0008% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294149|NCT02967510|OG003|Outcome|Placebo|Subjects received 1 gram of matching placebo vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294150|NCT02967510|EG000|Reported Event|Estriol 0.005%|Subjects received 1 gram of Estriol 0.005% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294151|NCT02967510|EG001|Reported Event|Estriol 0.002%|Subjects received 1 gram of Estriol 0.002% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294152|NCT02967510|EG002|Reported Event|Estriol 0.0008%|Subjects received 1 gram of Estriol 0.0008% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294153|NCT02967510|EG003|Reported Event|Placebo|Subjects received 1 gram of matching placebo vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12
11294154|NCT02967562|BG000|Baseline|Inflation Breaths|"Five 'inflation breaths' lasting two - three seconds~Inflation Breaths"
11294155|NCT02967562|BG001|Baseline|Sustained Inflation|"One fifteen second 'sustained inflation'~Sustained Inflation"
11294156|NCT02967562|BG002|Baseline|Total|Total of all reporting groups
11294157|NCT02967562|FG000|Participant Flow|Inflation Breaths|"Five 'inflation breaths' lasting two - three seconds~Inflation Breaths"
11294158|NCT02967562|FG001|Participant Flow|Sustained Inflation|"One fifteen second 'sustained inflation'~Sustained Inflation"
11294159|NCT02967562|OG000|Outcome|Inflation Breaths|"Five 'inflation breaths' lasting two - three seconds~Inflation Breaths"
11294160|NCT02967562|OG001|Outcome|Sustained Inflation|"One fifteen second 'sustained inflation'~Sustained Inflation"
11294161|NCT02967562|EG000|Reported Event|Inflation Breaths|"Five 'inflation breaths' lasting two - three seconds~Inflation Breaths"
11294162|NCT02967562|EG001|Reported Event|Sustained Inflation|"One fifteen second 'sustained inflation'~Sustained Inflation"
11294163|NCT02967679|BG000|Baseline|MD1003|MD1003 100mg capsules, 1 capsule tid for 48 weeks
11216521|NCT02308020|FG000|Participant Flow|Part A Abemaciclib: Hormone Receptor (HR+) HER2+ Breast Cancer|Abemaciclib 200 milligram (mg) was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive (HR+), hormone epidermal growth factor receptor 2 positive (HER2+) breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216522|NCT02308020|FG001|Participant Flow|Part B Abemaciclib: HR+, HER2- Breast Cancer|"Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).~Participants may continue to receive treatment until discontinuation criteria are met."
11216523|NCT02308020|FG002|Participant Flow|Part C Abemaciclib: Surgical Resection|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours for 5-14 days prior to surgical resection. Dosing may resume following wound healing on a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216524|NCT02308020|FG003|Participant Flow|Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216525|NCT02308020|FG004|Participant Flow|Part E Abemaciclib: Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216526|NCT02308020|FG005|Participant Flow|Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216527|NCT02308020|OG000|Outcome|Part A Abemaciclib: HR+, HER2+ Breast Cancer|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216528|NCT02308020|OG001|Outcome|Part B Abemaciclib: HR+, HER2- Breast Cancer|"Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).~Participants may continue to receive treatment until discontinuation criteria are met."
11216529|NCT02308020|OG002|Outcome|Part D Abemaciclib: NSCLC|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216530|NCT02308020|OG003|Outcome|Part E Abemaciclib: Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216531|NCT02308020|OG001|Outcome|Part B Abemaciclib: HR+, HER2- Breast Cancer|"Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).~Participants may continue to receive treatment until discontinuation criteria are met."
11216532|NCT02308020|OG000|Outcome|Part A Abemaciclib: HR+, HER2+ Breast Cancer|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216533|NCT02308020|OG000|Outcome|Part A 150 mg Abemaciclib: HR+, HER2+ Breast Cancer|Participants with HR+, HER2+ breast cancer received 150 mg abemaciclib orally once every 12 hours on days 1-21 of a 21-day cycle.
11216534|NCT02308020|OG001|Outcome|Part B 200 mg Abemaciclib: HR+, HER2- Breast Cancer|Participants with HR+, HER2- breast cancer received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
11216535|NCT02308020|OG002|Outcome|Part C 200 mg Abemaciclib: Surgical Resection|Participants with HR+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated received 200 mg abemaciclib given orally once every 12 hours for 5-14 days prior to surgical resection.
11216536|NCT02308020|OG003|Outcome|Part D 200 mg Abemaciclib: NSCLC|Participants with NSCLC received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
11216537|NCT02308020|OG004|Outcome|Part E 200 mg Abemaciclib: Melanoma|Participants with melanoma received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
11216538|NCT02308020|OG005|Outcome|Part F 200 mg Abemaciclib: HR+ Breast Cancer, NSCLC, Melanoma|Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
11294164|NCT02967679|FG000|Participant Flow|MD1003|MD1003 100mg capsules, 1 capsule tid for 48 weeks
11294165|NCT02967679|OG000|Outcome|MD1003|MD1003 100mg capsules, 1 capsule tid for 48 weeks
11294166|NCT02967679|EG000|Reported Event|MD1003|MD1003 100mg capsules, 1 capsule tid for 48 weeks
11294167|NCT02967991|BG000|Baseline|Total|"EUS-guided liver biopsy using a 19-gauge FNA then 22-gauge liver biopsy needle~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration"
11294168|NCT02967991|FG000|Participant Flow|19G EUS-FNA Needle First, Then 22G FNB Needle|"EUS-guided liver biopsy~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy~First Intervention: 10 minutes Washout: 1 minute Second Intervention: 10 minutes"
11294169|NCT02967991|FG001|Participant Flow|22G FNB Needle First, Then 19G EUS-FNA Needle|"EUS-guided liver biopsy~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy~First Intervention: 10 minutes Washout: 1 minute Second Intervention: 10 minutes"
11294170|NCT02967991|OG000|Outcome|19 Gauge FNA|"EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration"
11294171|NCT02967991|OG001|Outcome|22 Gauge FNB|"EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy"
11294172|NCT02967991|OG000|Outcome|Total Population|Adverse event evaluating the total population
11294173|NCT02967991|OG000|Outcome|Total Population|Adverse events evaluating the total population
11294174|NCT02967991|OG000|Outcome|Total Population|adverse event evaluating the total population
11294175|NCT02967991|OG000|Outcome|19 Gauge FNA|"EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy"
11294176|NCT02967991|OG001|Outcome|22 Gauge FNB|"EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy"
11294177|NCT02967991|EG000|Reported Event|Total Population|"EUS-guided liver biopsy using 19 g needle and 22 g needle in a cross-over design. Results were evaluated for groups undergoing 19 g needle followed by 22 g needle and 22 g needle followed by 19 g needle.~EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy~NOTE that as this is a cross-over design adverse events were reported occurred were reported on a per-patient basis. Given that events were reported after the procedure, unique to each patient, and cannot be expressed based upon a per-intervention basis as both interventions were performed on each patient and only one patient can have one unique intervention which is impossible to determine the route-source intervention as the culprit due to cross-over design same session."
11294178|NCT02968004|BG000|Baseline|MOD-4023|"Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)~MOD-4023: Once weekly subcutaneous injection using pre-filled pen device."
11294179|NCT02968004|BG001|Baseline|Genotropin|"Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)~Somatropin: Once daily subcutaneous injection of Genotropin"
11294180|NCT02968004|BG002|Baseline|Total|Total of all reporting groups
11294181|NCT02968004|FG000|Participant Flow|MOD-4023|"Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)~MOD-4023: Once weekly subcutaneous injection using pre-filled pen device."
11294182|NCT02968004|FG001|Participant Flow|Genotropin|"Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)~Somatropin: Once daily subcutaneous injection of Genotropin"
11294183|NCT02968004|OG000|Outcome|MOD-4023|"Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)~MOD-4023: Once weekly subcutaneous injection using pre-filled pen device."
11294184|NCT02968004|OG001|Outcome|Genotropin|"Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)~Somatropin: Once daily subcutaneous injection of Genotropin"
11294185|NCT02968004|EG000|Reported Event|MOD-4023|"Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)~MOD-4023: Once weekly subcutaneous injection using pre-filled pen device."
11294186|NCT02968004|EG001|Reported Event|Genotropin|"Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)~Somatropin: Once daily subcutaneous injection of Genotropin"
11294187|NCT02968134|BG000|Baseline|Posaconazole|"The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU~Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours."
11294188|NCT02968134|FG000|Participant Flow|Posaconazole|"The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU~Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours."
11294189|NCT02968134|OG000|Outcome|Posaconazole|"The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU~Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours."
11294190|NCT02968134|EG000|Reported Event|Posaconazole|"The study will enrol eight patients with presumed or confirmed systemic fungal infections, who are admitted to ICU~Posaconazole: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours."
11294191|NCT02968173|BG000|Baseline|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
11294192|NCT02968173|FG000|Participant Flow|Children at High Risk of Severe RSV Infection|A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the respiratory syncytial virus (RSV) season a participant was enrolled.
11294193|NCT02968173|OG000|Outcome|Children at High Risk of Severe RSV Infection|A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
11294194|NCT02968173|EG000|Reported Event|PALIVIZUMAB TEAE Within 30 Days|"A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.~Treatment-emergent adverse events (TEAEs) are defined as those that began after the first dose of study drug but within 30 days (+ 30 day assessment period) after the last dose of study drug."
11294195|NCT02968173|EG001|Reported Event|PALIVIZUMAB TEAE Within 100 Days|"A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.~TEAEs are defined as those that began after the first dose of study drug but within 100 days (+ 100 day assessment period) after the last dose of study drug."
11294196|NCT02968277|BG000|Baseline|Started With Forearm Support Walker (LW Upright)|Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
11294197|NCT02968277|BG001|Baseline|Started With Standard Rollator Walker|Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
11294198|NCT02968277|BG002|Baseline|Started With Predicate Device (PD)|Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
11294199|NCT02968277|BG003|Baseline|Total|Total of all reporting groups
11294200|NCT02968277|FG000|Participant Flow|Started With Forearm Support Walker (LW Upright)|Data collection began with participants using the LifeWalker Upright walker then the other two walkers in a randomized order
11294201|NCT02968277|FG001|Participant Flow|Started With Standard Rollator Walker|Data collection began with participants using a conventional standard rollator (SR) walker then the other two walkers in a randomized order
11294202|NCT02968277|FG002|Participant Flow|Started With Predicate Device (PD)|Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
11294203|NCT02968277|OG000|Outcome|Forearm Support Walker (LW Upright)|Data collected while participants used the LifeWalker Upright walker.
11294204|NCT02968277|OG001|Outcome|Standard Rollator Walker (Control)|Data collected while participants used a conventional standard rollator (SR) walker.
11294205|NCT02968277|OG002|Outcome|Predicate Device (PD)|Data collected while participants used their own rollator walkers.
11294206|NCT02968277|OG000|Outcome|Started With Forearm Support Walker (LW Upright)|Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order.
11294207|NCT02968277|OG001|Outcome|Started With Standard Rollator Walker|Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order.
11294208|NCT02968277|OG002|Outcome|Started With Predicate Device (PD)|Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
11294209|NCT02968277|OG002|Outcome|Started With Predicate Device (PD)|Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order.
11294210|NCT02968277|EG000|Reported Event|Forearm Support Walker (LW Upright)|This arm reflects time during which participants were using the LifeWalker Upright walker
11294211|NCT02968277|EG001|Reported Event|Standard Rollator (Control)|This arm reflects time during which participants were using a standard rollator walker
11294212|NCT02968277|EG002|Reported Event|Predicate Device (PD)|This arm reflects time during which participants were using their own rollator walkers
11294213|NCT02968368|BG000|Baseline|Oral Ferric Maltol|"30mg capsules BID~Ferric maltol"
11294214|NCT02968368|BG001|Baseline|Oral Placebo|"Matching placebo capsules BID~Placebo"
11294215|NCT02968368|BG002|Baseline|Total|Total of all reporting groups
11294216|NCT02968368|FG000|Participant Flow|Oral Ferric Maltol|"30mg capsules BID~Ferric maltol"
11294217|NCT02968368|FG001|Participant Flow|Oral Placebo|"Matching placebo capsules BID~Placebo"
11294218|NCT02968368|OG000|Outcome|Oral Ferric Maltol|"30mg capsules BID~Ferric maltol"
11294219|NCT02968368|OG001|Outcome|Oral Placebo|"Matching placebo capsules BID~Placebo"
11294220|NCT02968368|EG000|Reported Event|Oral Ferric Maltol DB|"30mg capsules BID~Ferric maltol~double blind phase"
11294221|NCT02968368|EG001|Reported Event|Oral Placebo DB|"Matching placebo capsules BID~Placebo~double blind phase"
11294222|NCT02968368|EG002|Reported Event|Oral Ferric Maltol OL|"30mg capsules BID~Ferric maltol~open label phase"
11294223|NCT02968368|EG003|Reported Event|Oral Placebo OL|"Matching placebo capsules BID~Placebo~open label phase"
11294224|NCT02968420|BG000|Baseline|Group 1|"Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294225|NCT02968420|BG001|Baseline|Group 2|"Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294226|NCT02968420|BG002|Baseline|Group 3|"Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294227|NCT02968420|BG003|Baseline|Total|Total of all reporting groups
11294228|NCT02968420|FG000|Participant Flow|Group 1|"Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294229|NCT02968420|FG001|Participant Flow|Group 2|"Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294230|NCT02968420|FG002|Participant Flow|Group 3|"Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294231|NCT02968420|OG000|Outcome|Group 1|"Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294232|NCT02968420|OG001|Outcome|Group 2|"Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294233|NCT02968420|OG002|Outcome|Group 3|"Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294234|NCT02968420|EG000|Reported Event|Group 1|"Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294235|NCT02968420|EG001|Reported Event|Group 2|"Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294236|NCT02968420|EG002|Reported Event|Group 3|"Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.~Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study."
11294237|NCT02968433|BG000|Baseline|Infusions of Young Plasma|"All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment.~Participants will receive 1 unit of young plasma, twice a week over a four week duration.~After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used.~Infusions of young plasma: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)"
11294238|NCT02968433|FG000|Participant Flow|Infusions of Young Plasma|"All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment.~Participants will receive 1 unit of young plasma, twice a week over a four week duration.~After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used.~Infusions of young plasma: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)"
11294239|NCT02968433|OG000|Outcome|Infusions of Young Plasma|"All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment.~Participants will receive 1 unit of young plasma, twice a week over a four week duration.~After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used.~Infusions of young plasma: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)"
11294240|NCT02968433|OG000|Outcome|Baseline|Before any treatment-related intervention began
11294241|NCT02968433|OG001|Outcome|Immediate-post Evaluation|Immediately after the last plasma infusion
11294242|NCT02968433|OG002|Outcome|Delayed-post Evaluation|4-weeks after the last plasma infusion
11294243|NCT02968433|OG000|Outcome|Baseline|Baseline rWFE task was completed before any treatment-related intervention.
11294244|NCT02968433|OG001|Outcome|Immediate-post Evaluation|Immediate-post rWFE task was completed on the day following the last infusion.
11294245|NCT02968433|OG002|Outcome|Delayed-post Evaluation|Delayed-post rWFE task was completed 4-weeks after the final infusion.
11294246|NCT02968433|EG000|Reported Event|Infusions of Young Plasma|"All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment.~Participants will receive 1 unit of young plasma, twice a week over a four week duration.~After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used.~Infusions of young plasma: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)"
11294247|NCT02968576|BG000|Baseline|All Participants|Single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.
11294248|NCT02968576|FG000|Participant Flow|Truvada First, Then Coencapsulated PSS-Truvada|Single dose of unencapsulated Truvada (Tenofovir disoproxil fumarate 300mg/Emtricitabine 200mg), 14-day washout followed by single dose of Truvada coencapsulated with the Proteus Sensor System (PSS) (device).
11294249|NCT02968576|FG001|Participant Flow|Coencapsulated PSS-Truvada First, Then Truvada|Single dose of Truvada (Tenofovir disoproxil fumarate 300mg/Emtricitabine 200mg) coencapsulated with the Proteus Sensor System (PSS) (device), 14-day washout followed by single dose of unencapsulated Truvada.
11294250|NCT02968576|OG000|Outcome|All Participants|Single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.
11294251|NCT02968576|EG000|Reported Event|All Subjects|Overall, the study showed an unremarkable and expected AE profile. At study initiation Truvada was FDA approved thus, the AE profile was already established. This study was not designed to collect new safety data or to update the established AE/Safety profiles for Truvada. Therefore AE data was combined for all dosing regimens since AEs reported per arm/group are not meaningful for research or clinical applications.
11294252|NCT02968758|BG000|Baseline|Accuracy Testing - Fresh Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294253|NCT02968758|BG001|Baseline|Accuracy Testing - Frozen Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294254|NCT02968758|BG002|Baseline|Total|Total of all reporting groups
11294255|NCT02968758|FG000|Participant Flow|Accuracy Testing - Fresh Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294256|NCT02968758|FG001|Participant Flow|Accuracy Testing - Frozen Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294257|NCT02968758|OG000|Outcome|Accuracy Testing - Fresh Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294258|NCT02968758|OG001|Outcome|Accuracy Testing - Frozen Specimen|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294259|NCT02968758|EG000|Reported Event|Accuracy Testing|"Comparison between GenePOC PCR and Reference Method~Comparison between GenePOC PCR and Reference Method: Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain."
11294260|NCT02968914|BG000|Baseline|Benralizumab 30mg Autoinjector (AI)|All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
11294261|NCT02968914|BG001|Baseline|Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)|All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
11294262|NCT02968914|BG002|Baseline|Total|Total of all reporting groups
11294263|NCT02968914|FG000|Participant Flow|Benralizumab 30mg Autoinjector (AI)|All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
11294264|NCT02968914|FG001|Participant Flow|Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)|All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
11294265|NCT02968914|OG000|Outcome|Benralizumab 30mg AI|All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
11294266|NCT02968914|OG001|Outcome|Benralizumab 30mg AFPS|All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
11294267|NCT02968914|EG000|Reported Event|Benralizumab 30mg Autoinjector (AI)|All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
11294268|NCT02968914|EG001|Reported Event|Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)|All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
11294269|NCT02968979|BG000|Baseline|NSCLC Patient|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
11294270|NCT02968979|FG000|Participant Flow|NSCLC Patient|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
11294271|NCT02968979|OG000|Outcome|NSCLC Patients With Cachexia|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
11294272|NCT02968979|OG000|Outcome|NSCLC Patients|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
11294273|NCT02968979|OG000|Outcome|Cancer Stage I-II|Patients with one of the following TNMs at the time of the visit: (T1a /T1b N0 M0) (T2a N0 M0) (T1a/T1b N1 M0 - T2a N1 M0 - T2b N0 M0) (T2b N1 M0 - T3 N0 M0)
11294274|NCT02968979|OG001|Outcome|Cancer Stage IIIA|Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)
11294275|NCT02968979|OG002|Outcome|Cancer Stage IIIB- IV|Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
11294276|NCT02968979|OG000|Outcome|Squamous Cell Carcinoma|Patients with squamous cell carcinoma
11294277|NCT02968979|OG001|Outcome|Adenocarcinoma|Patients with adenocarcinoma
11294278|NCT02968979|OG002|Outcome|Large Cell Carcinoma and Other Histology Type|Patients with large cell carcinoma and other histology type
11294279|NCT02968979|OG000|Outcome|Cachexia NSCLC Patients|"A patient was considered to have cachexia if he/she had:~Weight loss >5% in the last 6 months prior to inclusion or~BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or~Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.~In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%)."
11294280|NCT02968979|OG000|Outcome|Pre-Cachexia NSCLC Patients|"Pre-cachexia was defined as:~2% ≤ weight loss (WL) ≤ 5% and BMI ≥ 20 kg/m² or~anorexia or~sarcopenia and WL< 2%"
11294281|NCT02968979|OG000|Outcome|EGFR, ALK, ROS1, BRAF or HER2|NSCLC patients with at least one of the following molecular abnormalities : EGFR, ALK, ROS1, BRAF or HER2
11294282|NCT02968979|OG001|Outcome|K-RAS|NSCLC patients with a K-RAS molecular abnormality
11294283|NCT02968979|OG002|Outcome|No Mutation|NSCLC patients with no mutation
11294284|NCT02968979|OG000|Outcome|no NSCLC Treatment|Patient with no cancer treatment received for NSCLC
11294285|NCT02968979|OG001|Outcome|1 NSCLC Treatment|Patient with 1 cancer treatment received for NSCLC
11294286|NCT02968979|OG002|Outcome|2 NSCLC Treatments|Patient with 2 cancer treatments received for NSCLC
11294287|NCT02968979|OG003|Outcome|3 NSCLC Treatments|Patient with 3 cancer treatments received for NSCLC
11294288|NCT02968979|OG004|Outcome|at Least 4 NSCLC Treatments|Patient with at least 4 cancer treatments received for NSCLC
11294289|NCT02968979|OG000|Outcome|Surgery|Patient who had at least 1 surgery for NSCLC treatment
11294290|NCT02968979|OG001|Outcome|Radioterapy|Patient who received at least 1 radiotherapy for NSCLC treatment
11294291|NCT02968979|OG002|Outcome|Chemotherapy|Patient who received at least 1 chemotherapy for NSCLC treatment
11294292|NCT02968979|OG003|Outcome|Targeted Therapy|Patient with at least 1 targeted therapy received for NSCLC
11294293|NCT02968979|OG000|Outcome|Weight Loss >=15%|Patients with weight loss at inclusion >=15% of the weight 6 months prior to inclusion.
11294294|NCT02968979|OG001|Outcome|Weight Loss >=10%|Patients with weight loss at inclusion >=10% of the weight 6 months prior to inclusion.
11294295|NCT02968979|OG002|Outcome|Albuminemia < 30-35g/L|Patients with albuminemia < 30g/L (patient < 70 years old) or < 35g/L (patient ≥ 70 years old)
11294296|NCT02968979|OG003|Outcome|Pre-albuminemia < 110-200 mg/L|Patients with pre-albuminemia < 110g/L (patient < 70 years old) or < 200 mg/L (patient ≥ 70 years old)
11294297|NCT02968979|OG004|Outcome|BMI <18.5-21 kg/m²|BMI at inclusion visit < 18,5 kg/m² (patient < 70 years old) or < 21 kg/m² (patients≥70 years old)
11294298|NCT02968979|OG000|Outcome|Normal Blood Glucose|< 1g/L
11294299|NCT02968979|OG001|Outcome|Moderate Blood Glucose|>= 1g/L <= 1.26g/L
11294300|NCT02968979|OG002|Outcome|High Blood Glucose|>1.26g/L
11294301|NCT02968979|OG000|Outcome|No Cachexia|1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia
11294302|NCT02968979|OG001|Outcome|Pre-cachexia|1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia
11294303|NCT02968979|OG002|Outcome|Cachexia|1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
11294304|NCT02968979|OG003|Outcome|Refractory Cachexia|ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
11294305|NCT02968979|OG000|Outcome|Physical Scale|score ranging from 0 (malfunction) to 100 (healthy level of functioning)
11294306|NCT02968979|OG001|Outcome|Role Scale|score ranging from 0 (malfunction) to 100 (healthy level of functioning)
11294307|NCT02968979|OG002|Outcome|Cognitive Scale|score ranging from 0 (malfunction) to 100 (healthy level of functioning)
11294308|NCT02968979|OG003|Outcome|Emotional Scale|score ranging from 0 (malfunction) to 100 (healthy level of functioning)
11294309|NCT02968979|OG004|Outcome|Social Scale|score ranging from 0 (malfunction) to 100 (healthy level of functioning)
11294310|NCT02968979|OG000|Outcome|Cachexia According to Investigator|Patients with cachexia according to the subjective assessment of the clinician
11294311|NCT02968979|OG001|Outcome|Cachexia According to Fearon Criteria|1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
11294312|NCT02968979|OG000|Outcome|Anorexia According to Investigator|Patients with anorexia according to the subjective assessment of the clinician
11294313|NCT02968979|OG001|Outcome|Anorexia According to VAS|"Patients with anorexia according to Visual analogue scale for dietary intake.: Could you indicate the amount you currently eat, placing a vertical mark on the line between nothing at all and as usual? Depending on the location of the patient mark on the scale, a score of between 0 (nothing at all) and 10 (as usual) was allocated.~anorexia if score*100/990< 70mm."
11294314|NCT02968979|OG002|Outcome|Anorexia According to FAACT|Patients with anorexia according to Anorexia Cachexia/Subcale (AC/S) module of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire: anorexia if score <=37
11294315|NCT02968979|OG003|Outcome|Anorexia According to Question 13 of QLQ-C30 Questionnaire|"Patients with anorexia according to question 13 of the QLQ-C30 questionnaire: Have you had a lack of appetite?: anorexia if answer is a A little bit, Somewhat, Quite a bit"
11294316|NCT02968979|OG000|Outcome|Severe Malnutrition According to Investigator|Patients with severe malnutrition according to the subjective assessment of the clinician
11294317|NCT02968979|OG001|Outcome|Severe Malnutrition According to the HAS|"Patients with malnutrition according to the Haute Autorité de Santé:~weight loss ≥ 10%,~BMI measured during the inclusion visit <18.5 kg / m² for patients aged 70 and under and <21 kg / m² for patients over 70 years of age~Albumin <30 g / L if patient <70 years; or albumin <35g / L if patient ≥ 70 years~Pre-albumin <110 mg / L if patient <70 years"
11294318|NCT02968979|EG000|Reported Event|No Safety Data Was Collected|This is a non-interventional epidemiological study. No reporting of adverse reaction is expected in the study.
11294319|NCT02968992|BG000|Baseline|rhLactoferrin|"rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.~rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294320|NCT02968992|BG001|Baseline|Placebo|"Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.~Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294321|NCT02968992|BG002|Baseline|Total|Total of all reporting groups
11294322|NCT02968992|FG000|Participant Flow|rhLactoferrin|"rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.~rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294323|NCT02968992|FG001|Participant Flow|Placebo|"Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.~Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294324|NCT02968992|OG000|Outcome|rhLactoferrin|"rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.~rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294325|NCT02968992|OG001|Outcome|Placebo|"Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.~Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294326|NCT02968992|EG000|Reported Event|rhLactoferrin|"rH lactoferrin will be provided by Ventria Biosciences. Each capsule will contain 250 mg of rH lactoferrin as active ingredient. Subjects will receive 1500 mg of lactoferrin in capsule form twice a day. Dosing will be six 250 mg capsules twice a day for six months.~rhLactoferrin: Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294327|NCT02968992|EG001|Reported Event|Placebo|"Matching placebo capsule will be provided by Ventria Biosciences and six capsules twice a day will be provided to the subjects in this arm.~Placebo: Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy."
11294328|NCT02969018|BG000|Baseline|PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
11294329|NCT02969018|BG001|Baseline|PF-06700841 60 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
10971097|NCT00913913|FG000|Participant Flow|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
10971098|NCT00913913|OG000|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
10971099|NCT00913913|EG000|Reported Event|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
11294330|NCT02969018|BG002|Baseline|PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294331|NCT02969018|BG003|Baseline|PF-06700841 60 mg QD Followed by Placebo|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
11294332|NCT02969018|BG004|Baseline|PF-06700841 30 mg QD|Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
11294333|NCT02969018|BG005|Baseline|PF-06700841 30 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294334|NCT02969018|BG006|Baseline|PF-06700841 30 mg QD Followed by 100 mg QW|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294335|NCT02969018|BG007|Baseline|Placebo|Participants received 12 weeks of blinded matching placebo QD tablets.
11294336|NCT02969018|BG008|Baseline|Total|Total of all reporting groups
11294337|NCT02969018|FG000|Participant Flow|PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
11294338|NCT02969018|FG001|Participant Flow|PF-06700841 60 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294339|NCT02969018|FG002|Participant Flow|PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294340|NCT02969018|FG003|Participant Flow|PF-06700841 60 mg QD Followed by Placebo|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
11294341|NCT02969018|FG004|Participant Flow|PF-06700841 30 mg QD|Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
11294342|NCT02969018|FG005|Participant Flow|PF-06700841 30 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294343|NCT02969018|FG006|Participant Flow|PF-06700841 30 mg QD Followed by 100 mg QW|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294344|NCT02969018|FG007|Participant Flow|Placebo|Participants received 12 weeks of blinded matching placebo QD tablets.
11294345|NCT02969018|OG000|Outcome|PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
11294346|NCT02969018|OG001|Outcome|PF-06700841 60 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294347|NCT02969018|OG002|Outcome|PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294348|NCT02969018|OG003|Outcome|PF-06700841 60 mg QD Followed by Placebo|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
11294349|NCT02969018|OG004|Outcome|PF-06700841 30 mg QD|Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
11294350|NCT02969018|OG005|Outcome|PF-06700841 30 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294351|NCT02969018|OG006|Outcome|PF-06700841 30 mg QD Followed by 100 mg QW|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294352|NCT02969018|OG007|Outcome|Placebo|Participants received 12 weeks of blinded matching placebo QD tablets.
11294353|NCT02969018|OG000|Outcome|PF-06700841 60 mg QD as the Induction Dose|Participants received PF-06700841 60 mg QD as the induction dose.
11294354|NCT02969018|OG001|Outcome|PF-06700841 30 mg QD as the Induction Dose|Participants received PF-06700841 30 mg QD as the induction dose.
11294355|NCT02969018|OG002|Outcome|Placebo as the Induction Dose|Participants received matching placebo QD as the induction dose.
11294356|NCT02969018|EG000|Reported Event|PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
11294357|NCT02969018|EG001|Reported Event|PF-06700841 60 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294358|NCT02969018|EG002|Reported Event|PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294359|NCT02969018|EG003|Reported Event|PF-06700841 60 mg QD Followed by Placebo|Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
11294360|NCT02969018|EG004|Reported Event|PF-06700841 30 mg QD|Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
11294361|NCT02969018|EG005|Reported Event|PF-06700841 30 mg QD Followed by 10 mg QD|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
11294362|NCT02969018|EG006|Reported Event|PF-06700841 30 mg QD Followed by 100 mg QW|Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
11294363|NCT02969018|EG007|Reported Event|Placebo|Participants received 12 weeks of blinded matching placebo QD tablets.
11294364|NCT02969031|BG000|Baseline|Enhanced SCOPE Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.~Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process."
11294365|NCT02969031|BG001|Baseline|Standard Communication Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current standard communication PIM).~Standard Communication training: Standard Communication training"
11294366|NCT02969031|BG002|Baseline|Total|Total of all reporting groups
11294367|NCT02969031|FG000|Participant Flow|Enhanced SCOPE Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.~Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process."
11294368|NCT02969031|FG001|Participant Flow|Standard Communication Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current standard communication PIM).~Standard Communication training: Standard Communication training"
11294369|NCT02969031|OG000|Outcome|Enhanced SCOPE Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.~Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process."
11294370|NCT02969031|OG001|Outcome|Standard Communication Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current standard communication PIM).~Standard Communication training: Standard Communication training"
11294371|NCT02969031|EG000|Reported Event|Enhanced SCOPE Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.~Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process."
11294372|NCT02969031|EG001|Reported Event|Standard Communication Training|"Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current standard communication PIM).~Standard Communication training: Standard Communication training"
11294373|NCT02969044|BG000|Baseline|PF-06651600|Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294374|NCT02969044|BG001|Baseline|Placebo|Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294375|NCT02969044|BG002|Baseline|Total|Total of all reporting groups
11294376|NCT02969044|FG000|Participant Flow|PF-06651600|Participants received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294377|NCT02969044|FG001|Participant Flow|Placebo|Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294378|NCT02969044|OG000|Outcome|PF-06651600|Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294379|NCT02969044|OG001|Outcome|Placebo|Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294380|NCT02969044|EG000|Reported Event|PF-06651600|Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294381|NCT02969044|EG001|Reported Event|Placebo|Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
11294382|NCT02969187|BG000|Baseline|Experimental|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline~Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294383|NCT02969187|BG001|Baseline|Control|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294384|NCT02969187|BG002|Baseline|Total|Total of all reporting groups
11294385|NCT02969187|FG000|Participant Flow|Experimental|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm.~6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars.~Study arm receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline (total: 200ml)~Transverse Abdominis Plane (TAP) block: 140 ml~Port site infiltration:60ml"
11294386|NCT02969187|FG001|Participant Flow|Control|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm.~6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars.~Control arm receive 60ml of 0.5% Bupivacaine + 140 ml of Saline (total: 200ml)~Transverse Abdominis Plane (TAP) block: 140 ml~Port site infiltration:60ml"
11294387|NCT02969187|OG000|Outcome|Experimental|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline~Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294388|NCT02969187|OG001|Outcome|Control|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294389|NCT02969187|OG000|Outcome|Experimental|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm.~6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars.~Study arm receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline (total: 200ml)~Transverse Abdominis Plane (TAP) block: 140 ml~Port site infiltration:60ml"
11294390|NCT02969187|OG001|Outcome|Control|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm.~6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars.~Control arm receive 60ml of 0.5% Bupivacaine + 140 ml of Saline (total: 200ml)~Transverse Abdominis Plane (TAP) block: 140 ml~Port site infiltration:60ml"
11294391|NCT02969187|EG000|Reported Event|Experimental|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline~Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294392|NCT02969187|EG001|Reported Event|Control|"Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline.~Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.~Saline"
11294393|NCT02969317|BG000|Baseline|Tiotropium+Olodaterol 5 Microgram/5 Microgram|Patients were administered with 2 oral inhalations once daily (AM dosing) via RESPIMAT® inhaler of 2.5 μg per actuation of Tiotropium solution and 2.5 μg per actuation of Olodaterol solution
11294394|NCT02969317|FG000|Participant Flow|Tiotropium+Olodaterol 5 Microgram/5 Microgram|Patients were administered with 2 oral inhalations once daily (AM dosing) via RESPIMAT® inhaler of 2.5 μg per actuation of Tiotropium solution and 2.5 μg per actuation of Olodaterol solution
11294395|NCT02969317|OG000|Outcome|Tiotropium+Olodaterol FDC 5 mg/5 mg|Patients were administered with 2 oral inhalations once daily (AM dosing) via RESPIMAT® inhaler of 2.5 μg per actuation of Olodaterol solution
11294396|NCT02969317|OG000|Outcome|Tiotropium+Olodaterol FDC 5 mg/5 mg|Patients were administered with 2 oral inhalations once daily (AM dosing) via RESPIMAT® inhaler of 2.5 μg per actuation of Tiotropium solution
11294397|NCT02969317|EG000|Reported Event|Tiotropium+Olodaterol FDC 5 mg/5 mg|Patients were administered with 2 oral inhalations once daily (AM dosing) via RESPIMAT® inhaler of 2.5 μg per actuation of Olodaterol solution
11294398|NCT02969356|BG000|Baseline|Dysport|"Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection.~The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections.~Participants were also asked to perform daily GSC therapy throughout the study."
11294399|NCT02969356|FG000|Participant Flow|Dysport|"Dysport (AbobotulinumtoxinA) 1500 units (U) intramuscular (IM) injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection.~The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections.~Participants were also asked to perform daily GSC therapy throughout the study."
11294400|NCT02969356|OG000|Outcome|Dysport|"Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection.~The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections.~Participants were also asked to perform daily GSC therapy throughout the study."
11294401|NCT02969356|EG000|Reported Event|Dysport|"Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection.~The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections.~Participants were also asked to perform daily GSC therapy throughout the study."
11294402|NCT02969382|BG000|Baseline|Placebo|Placebo capsule once daily
11294403|NCT02969382|BG001|Baseline|SEP-363856|SEP-363856 capsule (50 mg or 75 mg) once daily
11294404|NCT02969382|BG002|Baseline|Total|Total of all reporting groups
11294405|NCT02969382|FG000|Participant Flow|Placebo|Placebo capsule once daily
11294406|NCT02969382|FG001|Participant Flow|SEP-363856|SEP-363856 capsule (50 mg or 75 mg) once daily
11294407|NCT02969382|OG000|Outcome|Placebo|Placebo capsule once daily
11294408|NCT02969382|OG001|Outcome|SEP-363856|SEP-363856 capsule (50 mg or 75 mg) once daily
11294409|NCT02969382|EG000|Reported Event|Placebo|Placebo capsule once daily
11294410|NCT02969382|EG001|Reported Event|SEP-363856|SEP-363856 capsule (50 mg or 75 mg) once daily
11294411|NCT02969408|BG000|Baseline|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
11294412|NCT02969408|FG000|Participant Flow|ABS eMDPI|Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
11294413|NCT02969408|OG000|Outcome|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
11294414|NCT02969408|EG000|Reported Event|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other asthma and non-asthma medications as advised by their physician without changes unless deemed necessary by their physician.
11294415|NCT02969421|BG000|Baseline|Slow Tenaculum Placement|"This group will have their tenaculum placed using the slow method~Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method"
11294416|NCT02969421|BG001|Baseline|Cough Method|"This group will have their tenaculum placed using the cough method~Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method"
11294417|NCT02969421|BG002|Baseline|Total|Total of all reporting groups
11294418|NCT02969421|FG000|Participant Flow|Slow Tenaculum Placement|"This group will have their tenaculum placed using the slow method~Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method"
11294419|NCT02969421|FG001|Participant Flow|Cough Method|"This group will have their tenaculum placed using the cough method~Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method"
11294420|NCT02969421|OG000|Outcome|Slow Tenaculum Placement|"This group will have their tenaculum placed using the slow method~Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method"
11294421|NCT02969421|OG001|Outcome|Cough Method|"This group will have their tenaculum placed using the cough method~Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method"
11294422|NCT02969421|EG000|Reported Event|Slow Tenaculum Placement|"This group will have their tenaculum placed using the slow method~Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method"
11294423|NCT02969421|EG001|Reported Event|Cough Method|"This group will have their tenaculum placed using the cough method~Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method"
10971100|NCT00913978|BG000|Baseline|Group 1: VitaHeat|"Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.~Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971101|NCT00913978|BG001|Baseline|Group 2: Bair Hugger|"Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.~Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971102|NCT00913978|BG002|Baseline|Total|Total of all reporting groups
10971103|NCT00913978|FG000|Participant Flow|Group 1: VitaHeat|"Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.~Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971104|NCT00913978|FG001|Participant Flow|Group 2: Bair Hugger|"Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.~Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971105|NCT00913978|OG000|Outcome|Group 1: VitaHeat|"Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.~Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971106|NCT00913978|OG001|Outcome|Group 2: Bair Hugger|"Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.~Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
11216539|NCT02308020|EG000|Reported Event|Part A Abemaciclib: HR+, HER2+ Breast Cancer|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with Endocrine Therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216540|NCT02308020|EG001|Reported Event|Part B Abemaciclib: HR+, HER2- Breast Cancer|"Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with Endocrine Therapy (ET).~Participants may continue to receive treatment until discontinuation criteria are met."
11216541|NCT02308020|EG002|Reported Event|Part C Abemaciclib: Surgical Resection|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with Endocrine Therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours for 5-14 days prior to surgical resection. Dosing may resume following wound healing on a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216542|NCT02308020|EG003|Reported Event|Part D Abemaciclib: NSCLC|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216543|NCT02308020|EG004|Reported Event|Part E Abemaciclib: Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216544|NCT02308020|EG005|Reported Event|Part F: Abemaciclib HR+ Breast Cancer, NSCLC, or Melanoma|Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with Endocrine Therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
11216545|NCT02308033|BG000|Baseline|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216546|NCT02308033|BG001|Baseline|Gel Vehicle|"One applicator full at bedtime~Gel vehicle"
11216547|NCT02308033|BG002|Baseline|Total|Total of all reporting groups
11216548|NCT02308033|FG000|Participant Flow|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216549|NCT02308033|FG001|Participant Flow|Gel Vehicle|"One applicator full at bedtime~Gel vehicle"
11216550|NCT02308033|OG000|Outcome|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216551|NCT02308033|OG001|Outcome|Gel Vehicle|"One applicator full at bedtime~Gel vehicle"
11216552|NCT02308033|EG000|Reported Event|Metronidazole Vaginal Gel|"One applicator full at bedtime~Metronidazole"
11216553|NCT02308033|EG001|Reported Event|Gel Vehicle|"One applicator full at bedtime~Gel vehicle"
11216554|NCT02308046|BG000|Baseline|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216555|NCT02308046|BG001|Baseline|Gel Vehicle|"One applicator full at bedtime~Placebo"
11216556|NCT02308046|BG002|Baseline|Total|Total of all reporting groups
11216557|NCT02308046|FG000|Participant Flow|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216558|NCT02308046|FG001|Participant Flow|Gel Vehicle|"One applicator full at bedtime~Placebo"
11216559|NCT02308046|OG000|Outcome|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216560|NCT02308046|OG001|Outcome|Gel Vehicle|"One applicator full at bedtime~Placebo"
11216561|NCT02308046|EG000|Reported Event|Terconazole Vaginal Gel|"One applicator full at bedtime~Terconazole"
11216562|NCT02308046|EG001|Reported Event|Gel Vehicle|"One applicator full at bedtime~Placebo"
11216563|NCT02308124|BG000|Baseline|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
11216564|NCT02308124|BG001|Baseline|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
11216565|NCT02308124|BG002|Baseline|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
11216566|NCT02308124|BG003|Baseline|Total|Total of all reporting groups
11216567|NCT02308124|FG000|Participant Flow|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
11216568|NCT02308124|FG001|Participant Flow|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
11216569|NCT02308124|FG002|Participant Flow|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
11216570|NCT02308124|OG000|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
11216571|NCT02308124|OG001|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
11216572|NCT02308124|OG002|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
11216573|NCT02308124|EG000|Reported Event|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
11216574|NCT02308124|EG001|Reported Event|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
11216575|NCT02308124|EG002|Reported Event|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
11216576|NCT02308163|BG000|Baseline|Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
11216577|NCT02308163|BG001|Baseline|Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
11216578|NCT02308163|BG002|Baseline|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
11216579|NCT02308163|BG003|Baseline|Placebo|Participants were assigned to receive placebo to peficitinib once a day until week 12.
11216580|NCT02308163|BG004|Baseline|Total|Total of all reporting groups
11216581|NCT02308163|FG000|Participant Flow|Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
11216582|NCT02308163|FG001|Participant Flow|Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
11216583|NCT02308163|FG002|Participant Flow|Placebo / Peficitinib 100 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
11216584|NCT02308163|FG003|Participant Flow|Placebo / Peficitinib 150 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
11216585|NCT02308163|FG004|Participant Flow|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
11216586|NCT02308163|OG000|Outcome|Placebo|Participants were assigned to receive placebo to peficitinib once a day until week 12.
11216587|NCT02308163|OG001|Outcome|Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
11216588|NCT02308163|OG002|Outcome|Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
11216589|NCT02308163|OG003|Outcome|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
11216590|NCT02308163|OG000|Outcome|Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
11216591|NCT02308163|OG001|Outcome|Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
11216592|NCT02308163|OG002|Outcome|Placebo / Peficitinib 100 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
11216593|NCT02308163|OG003|Outcome|Placebo / Peficitinib 150 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
11216594|NCT02308163|OG004|Outcome|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
11216595|NCT02308163|OG000|Outcome|Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks
11216596|NCT02308163|OG003|Outcome|Lacebo / Peficitinib 150 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
11216597|NCT02308163|OG002|Outcome|Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day for 52 weeks
11216598|NCT02308163|OG001|Outcome|Peficitinib 100 m|Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
11216599|NCT02308163|OG002|Outcome|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.New Group 3 Description
11216600|NCT02308163|OG002|Outcome|Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
11216601|NCT02308163|OG001|Outcome|Peficitinib 150 mg|assigned to receive peficitinib 150 mg/day for 52 weeks.
11216602|NCT02308163|EG000|Reported Event|Weeks 0-12: Placebo|Participants were assigned to receive placebo to peficitinib once a day until week 12.
11216603|NCT02308163|EG001|Reported Event|Weeks 0-12: Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day until 12 weeks.
11216604|NCT02308163|EG002|Reported Event|Weeks 0-12: Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day until 12 weeks.
11216605|NCT02308163|EG003|Reported Event|Weeks 0-12: Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks.
11216606|NCT02308163|EG004|Reported Event|Weeks 12-52: Peficitinib 100 mg|Participants were assigned to receive peficitinib 100 mg/day until 12 weeks and from week 12 to week 52.
11216607|NCT02308163|EG005|Reported Event|Weeks 12-52: Peficitinib 150 mg|Participants were assigned to receive peficitinib 150 mg/day until 12 weeks and from week 12 to week 52.
11216608|NCT02308163|EG006|Reported Event|Weeks 12-52: Placebo / Peficitinib 100 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
11216609|NCT02308163|EG007|Reported Event|Weeks 12-52: Placebo / Peficitinib 150 mg|Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
11216610|NCT02308163|EG008|Reported Event|Weeks 12-52: Etanercept|Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks and from week 12 to week 52.
11216611|NCT02308189|BG000|Baseline|Exercise|"Low load resistance exercise training~Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs."
11216612|NCT02308189|BG001|Baseline|Exercise With Blood Flow Restriction|"Low load resistance exercise training with blood flow restriction~Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises."
11216613|NCT02308189|BG002|Baseline|Total|Total of all reporting groups
11216614|NCT02308189|FG000|Participant Flow|Exercise|"Low load resistance exercise training~Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs."
11216615|NCT02308189|FG001|Participant Flow|Exercise With Blood Flow Restriction|"Low load resistance exercise training with blood flow restriction~Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises."
11216616|NCT02308189|OG000|Outcome|Exercise|"Low load resistance exercise training~Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs."
11216617|NCT02308189|OG001|Outcome|Exercise With Blood Flow Restriction|"Low load resistance exercise training with blood flow restriction~Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises."
11216618|NCT02308189|EG000|Reported Event|Exercise|"Low load resistance exercise training~Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs."
11216619|NCT02308189|EG001|Reported Event|Exercise With Blood Flow Restriction|"Low load resistance exercise training with blood flow restriction~Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises."
11216620|NCT02308228|BG000|Baseline|Metformin|"Participants will be randomized to receive Metformin (1700 mg/day) for a period of 16 weeks; 2 weeks of Metformin only followed by 14 weeks of continued Metformin use in combination with progressive resistance training.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.~Metformin: Participants will be randomized to receive metformin in conjunction with their strength training program."
11216621|NCT02308228|BG001|Baseline|Placebo, Sugar Pill|"Participants will be randomized to receive placebo sugar pills (1700 mg/day) for a period of 16 weeks; 2 weeks of placebo only followed by 14 weeks of continued placebo use in combination with progressive resistance training. Placebos will be almost identical to the Metformin medication.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally."
11216622|NCT02308228|BG002|Baseline|Total|Total of all reporting groups
11216623|NCT02308228|FG000|Participant Flow|Metformin|"Participants will be randomized to receive Metformin (1700 mg/day) for a period of 16 weeks; 2 weeks of Metformin only followed by 14 weeks of continued Metformin use in combination with progressive resistance training.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.~Metformin: Participants will be randomized to receive metformin in conjunction with their strength training program."
11294424|NCT02969499|BG000|Baseline|Study Participants|Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.
11294425|NCT02969499|FG000|Participant Flow|Study Participants|Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.
11294426|NCT02969499|OG000|Outcome|Study Participants|Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.
11294427|NCT02969499|EG000|Reported Event|Study Participants|Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.
11294428|NCT02969525|BG000|Baseline|Placebo|Participants received Placebo during the 12 Weeks Double-Blind Period.
11294429|NCT02969525|BG001|Baseline|BKZ 16 mg|Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
11294430|NCT02969525|BG002|Baseline|BKZ 160 mg|Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
11294431|NCT02969525|BG003|Baseline|BKZ 160 mg LD|Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
11294432|NCT02969525|BG004|Baseline|BKZ 320 mg|Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
11294433|NCT02969525|BG005|Baseline|Total Title|
11294434|NCT02969525|FG000|Participant Flow|Placebo|Participants received Placebo during the 12 Weeks Double-Blind Period.
11294435|NCT02969525|FG001|Participant Flow|BKZ 16 mg|Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
11294436|NCT02969525|FG002|Participant Flow|BKZ 160 mg|Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
11294437|NCT02969525|FG003|Participant Flow|BKZ 160 mg LD|Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
11294438|NCT02969525|FG004|Participant Flow|BKZ 320 mg|Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period.
11294439|NCT02969525|FG005|Participant Flow|Placebo - BKZ 160 mg|After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
11294440|NCT02969525|FG006|Participant Flow|Placebo - BZK 320 mg|After the 12 Weeks Double-Blind Period participants randomized to Placebo were re-randomized to receive Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
11294441|NCT02969525|FG007|Participant Flow|BKZ 16 mg - BKZ 160 mg|After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
11294442|NCT02969525|FG008|Participant Flow|BZK 16 mg - BZK 320 mg|After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
11294443|NCT02969525|FG009|Participant Flow|BZK 160 mg LD - BZK 160 mg|After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
11294444|NCT02969525|FG010|Participant Flow|BZK 160 mg - BKZ Dose 160 mg|After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
11294445|NCT02969525|FG011|Participant Flow|BKZ 320 mg - BKZ 320 mg|After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
11294446|NCT02969525|OG000|Outcome|Placebo (FAS)|Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11294447|NCT02969525|OG001|Outcome|BKZ 16 mg (FAS)|Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11294448|NCT02969525|OG002|Outcome|BKZ 160 mg (FAS)|Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
11294449|NCT02969525|OG003|Outcome|BKZ 160 mg LD (FAS)|Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).
11294450|NCT02969525|OG004|Outcome|BKZ 320 mg (FAS)|Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
11294451|NCT02969525|OG000|Outcome|Placebo (SS) - up to Wk 12|This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
11294452|NCT02969525|OG001|Outcome|BKZ 16 mg (SS) - up to Wk 12|This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11294453|NCT02969525|OG002|Outcome|BKZ 160 mg & 160 mg LD (SS) - up to Wk 68|This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
11294454|NCT02969525|OG003|Outcome|BKZ 320 mg (SS) - up to Wk 68|This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
11294455|NCT02969525|OG000|Outcome|Placebo (SS)|Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS).
11294456|NCT02969525|OG001|Outcome|BKZ 16 mg (SS)|Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
11294457|NCT02969525|OG002|Outcome|BKZ 160 mg (SS)|Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS.
11294458|NCT02969525|OG003|Outcome|BKZ 160 mg LD (SS)|Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS.
11294459|NCT02969525|OG004|Outcome|BKZ 320 mg (SS)|Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS.
11294460|NCT02969525|EG000|Reported Event|Placebo (SS) - up to Wk 12|This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
11294461|NCT02969525|EG001|Reported Event|BKZ 16 mg (SS) - up to Wk 12|This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
11294462|NCT02969525|EG002|Reported Event|BKZ 160 mg & 160 mg LD (SS) - up to Wk 68|This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
11294463|NCT02969525|EG003|Reported Event|BKZ 320 mg (SS) - up to Wk 68|This arm consisted of all participants who received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 68). Participants formed the SS.
11294464|NCT02969590|BG000|Baseline|Norethindrone, Then Estradiol Withdrawal|"This arm will receive Norethindrone (NET) first then experience estradiol withdrawal (E2WD).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294465|NCT02969590|BG001|Baseline|Estradiol Withdrawal, Then Norethindrone|"This arm will experience estradiol withdrawal (E2WD) first and then receive Norethindrone (NET).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294466|NCT02969590|BG002|Baseline|Total|Total of all reporting groups
11294467|NCT02969590|FG000|Participant Flow|Spontaneous Cycle|In order to qualify for the intervention phase, subjects needed to demonstrate favorable mucus at ovulation (Insler score of greater than or equal to 10 within 24h of an LH surge) and progesterone level in the luteal phase consistent with ovulation (a single P4 of greater than or equal to 3ng/ ml between days 18-35 of menstrual cycle).
11294468|NCT02969590|FG001|Participant Flow|NET Arm - Norethindrone, Then Estradiol Withdrawal|"This arm will receive Norethindrone (NET) first then experience estradiol withdrawal (E2WD).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294469|NCT02969590|FG002|Participant Flow|E2WD Arm - Estradiol Withdrawal, Then Norethindrone|"This arm will experience estradiol withdrawal (E2WD) first and then receive Norethindrone (NET).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294470|NCT02969590|OG000|Outcome|Norethindrone|"This arm will receive Norethindrone (NET) first then experience estradiol withdrawal (E2WD).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294471|NCT02969590|OG001|Outcome|Estradiol|"This arm will experience estradiol withdrawal (E2WD) first and then receive Norethindrone (NET).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294472|NCT02969590|OG000|Outcome|Spontaneous Cycle|"In order to qualify for the intervention phase, subjects needed to demonstrate favorable mucus at ovulation (Insler score of greater than or equal to 10 within 24h of an LH surge) and progesterone level in the luteal phase consistent with ovulation (a single P4 of greater than or equal to 3ng/ ml between days 18-35 of menstrual cycle).~Prior to the intervention cycle, each subject was observed over the normal natural cycle during which time we collected menstrual data including serum sex-steroid levels, mucus and cytology brushings for PGRMC1 analysis."
11294473|NCT02969590|OG001|Outcome|Norethindrone|"This arm will receive Norethindrone (NET) first then experience estradiol withdrawal (E2WD).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294474|NCT02969590|OG002|Outcome|Estradiol|"This arm will experience estradiol withdrawal (E2WD) first and then receive Norethindrone (NET).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294475|NCT02969590|EG000|Reported Event|Spontaneous Cycle|"Adverse Events experienced by subjects during Spontaneous Cycle.~In order to qualify for the intervention phase, subjects needed to demonstrate favorable mucus at ovulation (Insler score of greater than or equal to 10 within 24h of an LH surge) and progesterone level in the luteal phase consistent with ovulation (a single P4 of greater than or equal to 3ng/ ml between days 18-35 of menstrual cycle)."
11294476|NCT02969590|EG001|Reported Event|Norethindrone (NET)|"Adverse Events experienced by subjects for the Norethindrone intervention (while in the Norethindrone (NET) arm of study).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294477|NCT02969590|EG002|Reported Event|Estradiol (E2)|"Adverse Events experienced by subjects for the Estradiol (E2) intervention (while in the estradiol (E2) arm of study).~On the day prior to each admission, we instructed subjects to apply three fresh estradiol (E2) patches (0.3mg/day) to achieve mid-cycle level E2 effects.~On the day of the first and third admission, subjects were randomized to the experimental condition, either: (1) oral progestin administration (e.g., a single dose of 0.35mg norethindrone) with continuation of the E2 patches; or (2) estradiol withdrawal (e.g., removal of the patches). Subject then received the converse intervention for admissions two and four.~Subjects resumed treatment with the 0.1mg E2 patch until their next scheduled inpatient assessment. We required a minimum of five days at this level before repeating the dose escalation and the next evaluation."
11294478|NCT02969655|BG000|Baseline|Daprodustat|Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.
11216624|NCT02308228|FG001|Participant Flow|Placebo, Sugar Pill|"Participants will be randomized to receive placebo sugar pills (1700 mg/day) for a period of 16 weeks; 2 weeks of placebo only followed by 14 weeks of continued placebo use in combination with progressive resistance training. Placebos will be almost identical to the Metformin medication.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally."
11216625|NCT02308228|OG000|Outcome|Metformin|"Participants will be randomized to receive Metformin (1700 mg/day) for a period of 16 weeks; 2 weeks of Metformin only followed by 14 weeks of continued Metformin use in combination with progressive resistance training.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.~Metformin: Participants will be randomized to receive metformin in conjunction with their strength training program."
11216626|NCT02308228|OG001|Outcome|Placebo, Sugar Pill|"Participants will be randomized to receive placebo sugar pills (1700 mg/day) for a period of 16 weeks; 2 weeks of placebo only followed by 14 weeks of continued placebo use in combination with progressive resistance training. Placebos will be almost identical to the Metformin medication.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally."
11216627|NCT02308228|EG000|Reported Event|Metformin|"Participants will be randomized to receive Metformin (1700 mg/day) for a period of 16 weeks; 2 weeks of Metformin only followed by 14 weeks of continued Metformin use in combination with progressive resistance training.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.~Metformin: Participants will be randomized to receive metformin in conjunction with their strength training program."
11216628|NCT02308228|EG001|Reported Event|Placebo, Sugar Pill|"Participants will be randomized to receive placebo sugar pills (1700 mg/day) for a period of 16 weeks; 2 weeks of placebo only followed by 14 weeks of continued placebo use in combination with progressive resistance training. Placebos will be almost identical to the Metformin medication.~Progressive Resistance Training: Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally."
11216629|NCT02308371|BG000|Baseline|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
11216630|NCT02308371|BG001|Baseline|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
11216631|NCT02308371|BG002|Baseline|Total|Total of all reporting groups
11216632|NCT02308371|FG000|Participant Flow|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV> 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
11216633|NCT02308371|FG001|Participant Flow|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11216634|NCT02308371|OG000|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11216635|NCT02308371|OG001|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11216636|NCT02308371|OG000|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
11216637|NCT02308371|OG001|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
11216638|NCT02308371|EG000|Reported Event|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11216639|NCT02308371|EG001|Reported Event|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11216640|NCT02308501|BG000|Baseline|Lastacaft ® Eyes|"One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2.~If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days."
11216641|NCT02308501|BG001|Baseline|Tears Naturale® Eyes|"One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2.~If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days"
11216642|NCT02308501|BG002|Baseline|Total|Total of all reporting groups
11216643|NCT02308501|FG000|Participant Flow|Lastacaft ®|"One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2.~If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days."
11216644|NCT02308501|FG001|Participant Flow|Tears Naturale ® (Placebo)|One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days.
11216645|NCT02308501|OG000|Outcome|Lastacaft®|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216646|NCT02308501|OG001|Outcome|Tears Naturale ® (Placebo)|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216647|NCT02308501|OG000|Outcome|Lastacaft®|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 2 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216648|NCT02308501|OG001|Outcome|Tears Naturale ® (Placebo)|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 2 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216649|NCT02308501|OG001|Outcome|Tears Naturale ® (Placebo)|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft ® in the other eye at the same time).If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216650|NCT02308501|OG001|Outcome|Tears Naturale® (Placebo)|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
11216651|NCT02308501|EG000|Reported Event|Lastacaft®|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time)
11216652|NCT02308501|EG001|Reported Event|Tears Naturale ® (Placebo)|Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft ® in the other eye at the same time)
11216653|NCT02308540|BG000|Baseline|Adults--PCV 10|Single dose of SIILPCV 10 on Day 0
11216654|NCT02308540|BG001|Baseline|Adults--Pneumovax 23|Single dose of Pneumovax 23 on Day 0
11216655|NCT02308540|BG002|Baseline|Toddler--PCV 10|Single dose of SIILPCV 10 on Day 0
11216656|NCT02308540|BG003|Baseline|Toddler--Prevenar 13|Single dose of Prevenar 13 on Day 0
11216657|NCT02308540|BG004|Baseline|Infant--PCV 10|A 3-dose series of SIILPCV 10 on Day 0, Day 28, and Day 56.
11216658|NCT02308540|BG005|Baseline|Infant--Prevenar 13|A 3-dose series of Prevenar 13 on Day 0, Day 28, and Day 56.
11216659|NCT02308540|BG006|Baseline|Infant Boost--PCV 10|[Subset of infants in main study] Booster dose of SIILPCV 10 at 9 months of age
11216660|NCT02308540|BG007|Baseline|Infant Boost--Prevenar 13|[Subset of infants in main study] Booster dose of Prevenar 13 at 9 months of age
11216661|NCT02308540|BG008|Baseline|Total|Total of all reporting groups
11216662|NCT02308540|FG000|Participant Flow|Adult SIILPCV10|Single dose of SIILPCV10 on day 0
11216663|NCT02308540|FG001|Participant Flow|Adult Pneumovax 23|Single dose of Pneumovax 23 on day 0
11216664|NCT02308540|FG002|Participant Flow|Toddler SIILPCV10|Single dose of SIILPCV10 on day 0
11216665|NCT02308540|FG003|Participant Flow|Toddler Prevenar 13|Single dose of Prevenar 13 on day 0
11216666|NCT02308540|FG004|Participant Flow|Infants SIILPCV10|"A three-dose series of SIILPCV10 on day 0, day 28, and day 56; Booster dose of SIILPCV 10 at 9 months of age.~SIILPCV10: 10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate [alum]) and preservative (thiomersal)."
11216667|NCT02308540|FG005|Participant Flow|Infants Prevenar 13|"A three-dose series of Prevenar 13 on day 0, day 28, and day 56~Prevenar 13: 13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts"
11294479|NCT02969655|BG001|Baseline|Darbepoetin Alfa|Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.
11294480|NCT02969655|BG002|Baseline|Total|Total of all reporting groups
11294481|NCT02969655|FG000|Participant Flow|Daprodustat|Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.
11216668|NCT02308540|OG000|Outcome|Adults--PCV10|A single dose of SIILPCV 10 at Day 0
11216669|NCT02308540|OG001|Outcome|Adults--Pneumovax 23|A single dose of Pneumovax 23 at Day 0
11216670|NCT02308540|OG002|Outcome|Toddler--PCV 10|A single dose of SIIL PCV 10 at Day 0
11216671|NCT02308540|OG003|Outcome|Toddler--Prevenar 13|A single dose of Prevenar 13 at Day 0
11216672|NCT02308540|OG000|Outcome|Infant--PCV 10|Injection of SIIL PCV 10 given on Day 0
11216673|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Injection of Prevenar 13 on Day 0
11216674|NCT02308540|OG000|Outcome|Infant--PCV 10|Injection of SIIL PCV 10 given on Days 0 and 28
11216675|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Injection of Prevenar 13 on Days 0 and 28
11216676|NCT02308540|OG000|Outcome|Infant--PCV 10|Injection of SIIL PCV 10 given on Days 0, 28, & 56.
11216677|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Injection of Prevenar 13 on Days 0, 28, & 56.
11216678|NCT02308540|OG000|Outcome|Adults--PCV 10|Single dose of SIILPCV 10 at Day 0
11216679|NCT02308540|OG001|Outcome|Adults--Pneumovax 23|Single dose of Pneumovax 23 at Day 0
11216680|NCT02308540|OG002|Outcome|Toddler--PCV 10|Single dose of SIILPCV 10 at Day 0
11216681|NCT02308540|OG003|Outcome|Toddler--Prevenar 13|Single dose of Prevenar 13 at Day 0
11216682|NCT02308540|OG000|Outcome|Adult SIILPCV10|Single dose of SIILPCV10 on Day 0
11216683|NCT02308540|OG001|Outcome|Adult Pneumovax 23|Single dose of Pneumovax 23 on Day 0
11216684|NCT02308540|OG002|Outcome|Toddler SIILPCV10|Single dose of SIILPCV10 on Day 0
11216685|NCT02308540|OG003|Outcome|Toddler Prevenar 13|Single dose of Prevenar 13 on Day 0
11216686|NCT02308540|OG000|Outcome|Adults--PCV 10|Single dose of SIILPCV 10 on Day 0
11216687|NCT02308540|OG001|Outcome|Adults--Pneumovax 23|Single dose of Pneumovax 23 on Day 0
11216688|NCT02308540|OG000|Outcome|Toddler--PCV 10|Dose of SIILPCV 10 on Day 0
11216689|NCT02308540|OG001|Outcome|Toddler--Prevenar 13|Dose of Prevenar 13 on Day 0
11216690|NCT02308540|OG000|Outcome|Infant--PCV 10|Dose of SIILPCV 10 on Day 0, 28 and 56
11216691|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Dose of Prevenar 13 on Day 0, 28 and 56
11216692|NCT02308540|OG000|Outcome|Toddler--PCV 10|Single dose of SIILPCV 10 on Day 0
11216693|NCT02308540|OG001|Outcome|Toddler--Prevenar 13|Single dose of Prevenar 13 on Day 0
11216694|NCT02308540|OG000|Outcome|Infant--PCV 10|Dose of SIILPCV 10 on Days 0, 28 & 56
11216695|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Dose of Prevenar 13 on Days 0, 28, & 56
11216696|NCT02308540|OG002|Outcome|Toddler--PCV 10|Single dose of SIILPCV 10 on Day 0
11216697|NCT02308540|OG003|Outcome|Toddler--Prevenar 13|Single dose of Prevenar 13 on Day 0
11216698|NCT02308540|OG004|Outcome|Infant--PCV 10|Dose of SIILPCV 10 on Days 0, 28 & 56
11216699|NCT02308540|OG005|Outcome|Infant--Prevenar 13|Dose of Prevenar 13 on Days 0, 28, & 56
11216700|NCT02308540|OG000|Outcome|Infant--PCV 10|Booster injection of SIILPCV 10 at 9 months of age
11216701|NCT02308540|OG001|Outcome|Prevenar 13|Booster injection of Prevenar 13 at 9 months of age
11216702|NCT02308540|OG000|Outcome|Infant--PCV 10|Booster dose of SIILPCV 10 at 10 months of age
11216703|NCT02308540|OG001|Outcome|Prevenar 13|Booster dose of Prevenar 13 at 10 months of age
11216704|NCT02308540|OG001|Outcome|Infant--Prevenar 13|Booster dose of Prevenar 13 at 10 months of age
11216705|NCT02308540|OG002|Outcome|Treatment Comparison (GMC Ratio)|This column is the GMC Ratio between the SIILPCV 10 and the Prevenar 13 groups
11216706|NCT02308540|OG002|Outcome|GMFR Ratio|This column is the GMFR ratio between the SIILPCV 10 group and the Prevenar 13 group.
11216707|NCT02308540|EG000|Reported Event|Adult SIILPCV 10|Single dose of SIILPCV10 on Day 0
11216708|NCT02308540|EG001|Reported Event|Adult Pneumovax 23|Single dose of Pneumovax 23 on Day 0
11216709|NCT02308540|EG002|Reported Event|Toddler SIILPCV 10|Single dose of SIILPCV10 on Day 0
11216710|NCT02308540|EG003|Reported Event|Toddler Prevenar 13|Single dose of Prevenar 13 on Day 0
11216711|NCT02308540|EG004|Reported Event|Infants SIILPCV 10|A 3-dose series of SIILPCV 10 on Days 0, 28, & 56
11216712|NCT02308540|EG005|Reported Event|Infants Prevenar 13|A 3-dose series of Prevenar 13 on Days 0, 28, & 56
11216713|NCT02308540|EG006|Reported Event|Booster Infants SIILPCV 10|Booster dose of SIILPCV 10 at 9 months of age
11216714|NCT02308540|EG007|Reported Event|Booster Infants Prevenar 13|Booster dose of Prevenar 13 at 9 months of age
11216715|NCT02308696|BG000|Baseline|Peer-to-peer Support (Non-randomized)|"222 older adults that are currently receiving peer-to-peer support~Peer-to-Peer Support: All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services."
11216716|NCT02308696|BG001|Baseline|Standard Services (Non-randomized)|"234 older adults will continue receiving standard community services~Standard Community Services: All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program"
11216717|NCT02308696|BG002|Baseline|Total|Total of all reporting groups
10971107|NCT00913978|EG000|Reported Event|Group 1: VitaHeat|"Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.~Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971108|NCT00913978|EG001|Reported Event|Group 2: Bair Hugger|"Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.~Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C."
10971109|NCT00914069|BG000|Baseline|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
10971110|NCT00914069|BG001|Baseline|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
11294482|NCT02969655|FG001|Participant Flow|Darbepoetin Alfa|Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.
11294483|NCT02969655|OG000|Outcome|Daprodustat|Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.
11294484|NCT02969655|OG001|Outcome|Darbepoetin Alfa|Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.
11294485|NCT02969655|OG000|Outcome|Darbepoetin Alfa|Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.
11294486|NCT02969655|EG000|Reported Event|Daprodustat|Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.
11294487|NCT02969655|EG001|Reported Event|Darbepoetin Alfa|Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.
11294488|NCT02969707|BG000|Baseline|Active rTMS|"The active group received active repetitive Transcranial Magnetic Stimulation~Active repetitive Transcranial Magnetic Stimulation: The investigators performed two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC was determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 was utilized for this localization process. rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294489|NCT02969707|BG001|Baseline|Sham rTMS|"The sham repetitive Transcranial Magnetic Stimulation group had the stimulation blocked.~Sham repetitive Transcranial Magnetic Stimulation: This was identical to active rTMS except the stimulation was blocked. Both active and sham repetitive Transcranial Magnetic Stimulation received simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater. Sham rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294490|NCT02969707|BG002|Baseline|Total|Total of all reporting groups
11294491|NCT02969707|FG000|Participant Flow|Active rTMS|"The active group received active repetitive Transcranial Magnetic Stimulation~Active repetitive Transcranial Magnetic Stimulation: The investigators performed two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left dorsolateral prefrontal cortex (DLPFC) was determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 was utilized for this localization process. rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294492|NCT02969707|FG001|Participant Flow|Sham rTMS|"The sham repetitive Transcranial Magnetic Stimulation group had the stimulation blocked.~Sham repetitive Transcranial Magnetic Stimulation: This was identical to active rTMS except the stimulation was blocked. Both active and sham repetitive Transcranial Magnetic Stimulation received simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater. Sham rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294493|NCT02969707|OG000|Outcome|Active rTMS|"The active group received active repetitive Transcranial Magnetic Stimulation~Active repetitive Transcranial Magnetic Stimulation: The investigators performed two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC was determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 was utilized for this localization process. rTMS was delivered using a MagPro TMS system (MagVenture, Denmark).utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark)."
10971111|NCT00914069|BG002|Baseline|Total|Total of all reporting groups
11294494|NCT02969707|OG001|Outcome|Sham rTMS|"The sham repetitive Transcranial Magnetic Stimulation group had the stimulation blocked.~Sham repetitive Transcranial Magnetic Stimulation: This was identical to active rTMS except the stimulation was blocked. Both active and sham repetitive Transcranial Magnetic Stimulation received simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater. Sham rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294495|NCT02969707|OG000|Outcome|Active rTMS|"The active group received active repetitive Transcranial Magnetic Stimulation.~Active repetitive Transcranial Magnetic Stimulation: The investigators performed two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC was determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 was utilized for this localization process. rTMS was delivered using a MagPro TMS system (MagVenture, Denmark)."
11294496|NCT02969707|OG000|Outcome|Active rTMS|"The active group will receive repetitive Transcranial Magnetic Stimulation~repetitive Transcranial Magnetic Stimulation: The investigators will perform two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC will be determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 will be utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark)."
11294497|NCT02969707|OG001|Outcome|Sham rTMS|"The sham repetitive Transcranial Magnetic Stimulation group will have the stimulation blocked.~Sham repetitive Transcranial Magnetic Stimulation: This will be identical to active rTMS except the stimulation will be blocked. Both active and sham repetitive Transcranial Magnetic Stimulation will receive simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark)."
11294498|NCT02969707|OG000|Outcome|Active rTMS|The active group received active repetitive Transcranial Magnetic Stimulation Active repetitive Transcranial Magnetic Stimulation: The investigators performed two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC was determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 was utilized for this localization process. rTMS was delivered using a MagPro TMS system (MagVenture, Denmark).utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark).
11294499|NCT02969707|OG000|Outcome|Baseline Fibromyalgia MRSPEC Analysis|MEGA-PRESS (Mescher M, Merkle H, Kirsch J, Garwood M, Gruetter R, 1998) Spectra were acquired during baseline scanning for TMS-naive participants with Fibromyalgia before any intervention as part of an F32 grant.
11294500|NCT02969707|EG000|Reported Event|Active rTMS|"The active group will receive repetitive Transcranial Magnetic Stimulation~repetitive Transcranial Magnetic Stimulation: The investigators will perform two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC will be determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 will be utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark)."
11294501|NCT02969707|EG001|Reported Event|Sham rTMS|"The sham repetitive Transcranial Magnetic Stimulation group will have the stimulation blocked.~Sham repetitive Transcranial Magnetic Stimulation: This will be identical to active rTMS except the stimulation will be blocked. Both active and sham repetitive Transcranial Magnetic Stimulation will receive simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark)."
11294502|NCT02969863|BG000|Baseline|All Participants|All participants who began participating in the study
11294503|NCT02969863|FG000|Participant Flow|BBPM First, Then BBP, Then UCM, Then UC, Then IOBPM, Then IOBP|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294504|NCT02969863|FG001|Participant Flow|UCM First, Then UC, Then IOBPM, Then IOBP, Then BBPM, Then BBP|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294505|NCT02969863|FG002|Participant Flow|IOBPM First, Then IOBP, Then BBPM, Then BBP, Then UCM, Then UC|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294506|NCT02969863|FG003|Participant Flow|UC First, Then UCM, Then BBP, Then BBPM, Then IOBP, Then IOBPM|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294507|NCT02969863|FG004|Participant Flow|IOBP First, Then IOBPM, Then UC, Then UCM, Then BBP, Then BBPM|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294508|NCT02969863|FG005|Participant Flow|BBP First, Then BBPM, Then IOBP, Then IOBPM, Then UC, Then UCM|"UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week~IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm.~BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm~M-arm includes real-time remote monitoring for hypoglycemia"
11294509|NCT02969863|OG000|Outcome|Usual Care Arm - Monitored|"Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294510|NCT02969863|OG001|Outcome|Usual Care Arm - Unmonitored|"Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11294511|NCT02969863|OG002|Outcome|Bihormonal Bionic Pancreas - Monitored|"Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294512|NCT02969863|OG003|Outcome|Bihormonal Bionic Pancreas - Unmonitored|"Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11294513|NCT02969863|OG004|Outcome|Insulin Only Bionic Pancreas - Monitored|"Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294514|NCT02969863|OG005|Outcome|Insulin Only Bionic Pancreas - Unmonitored|"Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11332593|NCT03497845|OG000|Outcome|a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10971112|NCT00914069|FG000|Participant Flow|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
11294515|NCT02969863|EG000|Reported Event|Usual Care Arm - Monitored|"Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294516|NCT02969863|EG001|Reported Event|Usual Care Arm - Unmonitored|"Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11294517|NCT02969863|EG002|Reported Event|Bihormonal Bionic Pancreas - Monitored|"Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294518|NCT02969863|EG003|Reported Event|Bihormonal Bionic Pancreas - Unmonitored|"Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11294519|NCT02969863|EG004|Reported Event|Insulin Only Bionic Pancreas - Monitored|"Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.~Monitored for hypoglycemia~Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.~Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues."
11294520|NCT02969863|EG005|Reported Event|Insulin Only Bionic Pancreas - Unmonitored|"Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.~Not monitored for hypoglycemia~Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.~Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia."
11294521|NCT02969876|BG000|Baseline|Study Phase|"During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical & Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.~Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder."
11294522|NCT02969876|FG000|Participant Flow|Open Trial Vortioxetine|All enrolled participants received open trial of Vortioxetine for 6 weeks.
11294523|NCT02969876|OG000|Outcome|Study Phase|"During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical & Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.~Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder."
11294524|NCT02969876|OG000|Outcome|Open Trial Vortioxetine|All enrolled participants received open trial of Vortioxetine for 6 weeks.
11294525|NCT02969876|EG000|Reported Event|Open Trial Vortioxetine|All enrolled participants received open trial of Vortioxetine for 6 weeks.
11294526|NCT02970006|BG000|Baseline|Neurovisual Stimulation|"Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.~neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)"
11332594|NCT03497845|OG001|Outcome|b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10971113|NCT00914069|FG001|Participant Flow|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
10971114|NCT00914069|OG000|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
11216718|NCT02308696|FG000|Participant Flow|Peer-to-peer Support (Non-randomized)|"222 older adults that are currently receiving peer-to-peer support~Peer-to-Peer Support: All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services."
11216719|NCT02308696|FG001|Participant Flow|Standard Services (Non-randomized)|"234 older adults will continue receiving standard community services~Standard Community Services: All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program"
10971115|NCT00914069|OG001|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
11216720|NCT02308696|OG000|Outcome|Peer-to-peer Support (Non-randomized)|"222 older adults that are currently receiving peer-to-peer support~Peer-to-Peer Support: All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services."
11216721|NCT02308696|OG001|Outcome|Standard Services (Non-randomized)|"234 older adults will continue receiving standard community services~Standard Community Services: All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program"
11216722|NCT02308696|EG000|Reported Event|Peer-to-peer Support (Non-randomized)|"222 older adults that are currently receiving peer-to-peer support~Peer-to-Peer Support: All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services."
11216723|NCT02308696|EG001|Reported Event|Standard Services (Non-randomized)|"234 older adults will continue receiving standard community services~Standard Community Services: All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program"
11216724|NCT02308748|BG000|Baseline|All Study Participants|Participants who were randomized to receive either dofetilide alone, dofetilide + mexiletine, dofetilide + lidocaine, moxifloxacin + diltiazem or placebo.
11216725|NCT02308748|FG000|Participant Flow|A-D-E-C-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine)"
11216726|NCT02308748|FG001|Participant Flow|B-C-E-D-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide)"
11216727|NCT02308748|FG002|Participant Flow|C-D-B-A-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment E (placebo)"
11216728|NCT02308748|FG003|Participant Flow|D-C-A-B-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment E (placebo)"
11216729|NCT02308748|FG004|Participant Flow|E-A-B-D-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine)"
11216730|NCT02308748|FG005|Participant Flow|D-A-C-E-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment B (dofetilide + lidocaine)"
11216731|NCT02308748|FG006|Participant Flow|E-B-A-C-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem)"
11216732|NCT02308748|FG007|Participant Flow|A-E-D-B-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine)"
11294527|NCT02970006|FG000|Participant Flow|Neurovisual Stimulation|"Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.~neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)"
11294528|NCT02970006|OG000|Outcome|Neurovisual Stimulation|"Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.~neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)"
11294529|NCT02970006|EG000|Reported Event|Neurovisual Stimulation|"Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.~neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)"
11294530|NCT02970032|BG000|Baseline|Standard Heparin Dose Followed by Dose Adjustment|The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels.Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL. Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
11294531|NCT02970032|FG000|Participant Flow|Standard Heparin Dose Followed by Dose Adjustment|"The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.~Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged."
11294532|NCT02970032|OG000|Outcome|Standard Heparin Dose Followed by Dose Adjustment|"The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.~Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged."
11294533|NCT02970032|EG000|Reported Event|Standard Heparin Dose|"The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.~Standard heparin dose: Patients will be placed on heparin infusions per their surgeon's discretion."
11294534|NCT02970032|EG001|Reported Event|Real Time Heparin Dose Adjustment|"Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.~Real time heparin dose adjustment: Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels."
11294535|NCT02970162|BG000|Baseline|Amifampridine Phosphate|"amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days~Amifampridine Phosphate"
11294536|NCT02970162|BG001|Baseline|Placebo (for Amifampridine Phosphate)|"placebo by mouth 3 to 4 times per day for 4 days~Placebo Oral Tablet"
11294537|NCT02970162|BG002|Baseline|Total|Total of all reporting groups
11294538|NCT02970162|FG000|Participant Flow|Amifampridine Phosphate|"amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days~Amifampridine Phosphate"
11294539|NCT02970162|FG001|Participant Flow|Placebo (for Amifampridine Phosphate)|"placebo by mouth 3 to 4 times per day for 4 days~Placebo Oral Tablet"
11294540|NCT02970162|OG000|Outcome|Amifampridine Phosphate|"amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days~Amifampridine Phosphate"
11294541|NCT02970162|OG001|Outcome|Placebo (for Amifampridine Phosphate)|"placebo by mouth 3 to 4 times per day for 4 days~Placebo Oral Tablet"
11294542|NCT02970162|EG000|Reported Event|Amifampridine Phosphate|"amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days~Amifampridine Phosphate"
11294543|NCT02970162|EG001|Reported Event|Placebo (for Amifampridine Phosphate)|"placebo by mouth 3 to 4 times per day for 4 days~Placebo Oral Tablet"
11294544|NCT02970292|BG000|Baseline|Pimavanserin|"Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.~Patients were to continue their background antipsychotic treatment."
11294545|NCT02970292|BG001|Baseline|Placebo|"Pimavanserin-matching Placebo.~Patients were to continue their background antipsychotic treatment."
11294546|NCT02970292|BG002|Baseline|Total|Total of all reporting groups
11294547|NCT02970292|FG000|Participant Flow|Pimavanserin|"Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.~Patients were to continue their background antipsychotic treatment."
11294548|NCT02970292|FG001|Participant Flow|Placebo|"Pimavanserin-matching Placebo.~Patients were to continue their background antipsychotic treatment."
11294549|NCT02970292|OG000|Outcome|Pimavanserin|"Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.~Patients were to continue their background antipsychotic treatment."
11294550|NCT02970292|OG001|Outcome|Placebo|"Pimavanserin-matching Placebo.~Patients were to continue their background antipsychotic treatment."
11294551|NCT02970292|EG000|Reported Event|Pimavanserin|"Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.~Patients were to continue their background antipsychotic treatment."
11294552|NCT02970292|EG001|Reported Event|Placebo|"Pimavanserin-matching Placebo.~Patients were to continue their background antipsychotic treatment."
11294553|NCT02970305|BG000|Baseline|Pimavanserin|"Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).~Patients were to continue their background antipsychotic treatment"
11294554|NCT02970305|BG001|Baseline|Placebo|"Pimavanserin matching placebo once daily~Patients were to continue their background antipsychotic treatment"
11294555|NCT02970305|BG002|Baseline|Total|Total of all reporting groups
11294556|NCT02970305|FG000|Participant Flow|Pimavanserin|"Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).~Patients were to continue their background antipsychotic treatment"
11294557|NCT02970305|FG001|Participant Flow|Placebo|"Pimavanserin matching placebo once daily~Patients were to continue their background antipsychotic treatment"
11294558|NCT02970305|OG000|Outcome|Pimavanserin|"Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).~Patients were to continue their background antipsychotic treatment"
10971116|NCT00914069|EG000|Reported Event|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
11294559|NCT02970305|OG001|Outcome|Placebo|"Pimavanserin matching placebo once daily~Patients were to continue their background antipsychotic treatment"
11294560|NCT02970305|EG000|Reported Event|Pimavanserin|"Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).~Patients were to continue their background antipsychotic treatment"
11294561|NCT02970305|EG001|Reported Event|Placebo|"Pimavanserin matching placebo once daily~Patients were to continue their background antipsychotic treatment"
11294562|NCT02970422|BG000|Baseline|All Participants|Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
11294563|NCT02970422|FG000|Participant Flow|All Participants|Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
11294564|NCT02970422|OG000|Outcome|Participation Differences by Individuals' Disease Severity|For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
11294565|NCT02970422|OG001|Outcome|Participation Differences by (GOLD) ABCD Classification|Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
11294566|NCT02970422|OG002|Outcome|Quartile 1 - Mild Airflow Obstruction|FEV1%predicted range = 65.1-184.8
11294567|NCT02970422|OG003|Outcome|Quartile 2 - Moderate Airflow Obstruction|FEV1% predicted range = 48.4-64.3
11294568|NCT02970422|OG004|Outcome|Quartile 3 - Severe Airflow Obstruction|FEV1% predicted range = 31.7-46.8
11294569|NCT02970422|OG005|Outcome|Quartile 4 - Very Severe Airflow Obstruction|FEV1% predicted range = 14.7-31.5
11294570|NCT02970422|OG006|Outcome|Group A - Breathlessness Burden and Exacerbation Risk|FEV1%predicted range = 42.3-69.4
11294571|NCT02970422|OG007|Outcome|Group B - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range = 28.0-65.9
11294572|NCT02970422|OG008|Outcome|Group C - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range = 27.0-67.0
11294573|NCT02970422|OG009|Outcome|Group D - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range = 27.0-67.7
11294574|NCT02970422|OG001|Outcome|Participation Differences by (GOLD) ABCD|Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
11294575|NCT02970422|OG002|Outcome|Quartile 1- Mild Airflow Obstruction|FEV1% predicted range: 65.1-184.8
11294576|NCT02970422|OG003|Outcome|Quartile 2 - Moderate Airflow Obstruction|FEV1% predicted range: 48.4-64.3
11294577|NCT02970422|OG004|Outcome|Quartile 3 - Severe Airflow Obstruction|FEV1% predicted range: 31.7-46.8
11294578|NCT02970422|OG005|Outcome|Quartile 4 - Very Severe Airflow Obstruction|FEV1% predicted range: 14.7-31.5
11294579|NCT02970422|OG006|Outcome|Group A - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range: 42.3-69.4
11294580|NCT02970422|OG007|Outcome|Group B - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range:28.0-65.9
11294581|NCT02970422|OG008|Outcome|Group C - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range:27.0-67.0
11294582|NCT02970422|OG009|Outcome|Group D - Breathlessness Burden and Exacerbation Risk|FEV1% predicted range:27.0-67.0
11294583|NCT02970422|OG005|Outcome|Quartile 4 - Very Severe Airflow Obstruction|Quartile 4 - Very Severe Airflow Obstruction
11294584|NCT02970422|EG000|Reported Event|All Participants|Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
11294585|NCT02970552|BG000|Baseline|Vaginal Progesterone|"Daily self-administered vaginal progesterone~Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository"
11294586|NCT02970552|BG001|Baseline|Placebo|"Daily self-administered indistinguishable placebo~Placebo: Indistinguishable placebo vaginal suppository"
11294587|NCT02970552|BG002|Baseline|Total|Total of all reporting groups
11294588|NCT02970552|FG000|Participant Flow|Vaginal Progesterone|"Daily self-administered vaginal progesterone~Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository"
11294589|NCT02970552|FG001|Participant Flow|Placebo|"Daily self-administered indistinguishable placebo~Placebo: Indistinguishable placebo vaginal suppository"
11294590|NCT02970552|OG000|Outcome|Vaginal Progesterone|"Daily self-administered vaginal progesterone~Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository"
11294591|NCT02970552|OG001|Outcome|Placebo|"Daily self-administered indistinguishable placebo~Placebo: Indistinguishable placebo vaginal suppository"
11294592|NCT02970552|OG000|Outcome|Vaginal Progesterone|Daily self-administered vaginal progesterone Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository
11294593|NCT02970552|OG001|Outcome|Placebo|Daily self-administered indistinguishable placebo Placebo: Indistinguishable placebo vaginal suppository
11294594|NCT02970552|OG000|Outcome|Daily Dose Diaries|Dose diaries completed by randomized participants returned at each follow-up visit
11294595|NCT02970552|OG000|Outcome|Women Eligible for Screening|Women eligible for study screening
11294596|NCT02970552|EG000|Reported Event|Vaginal Progesterone|"Daily self-administered vaginal progesterone~Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository"
11294597|NCT02970552|EG001|Reported Event|Placebo|"Daily self-administered indistinguishable placebo~Placebo: Indistinguishable placebo vaginal suppository"
11294598|NCT02970669|BG000|Baseline|Enalapril|Double-blind Treatment Period (Week 1 - Week 8): Enalapril Open-label Treatment Period (Week 9 - Week 16): Sacubitril/Valsartan
11294599|NCT02970669|BG001|Baseline|Sacubitril/Valsartan|Double-blind Treatment Period (Week 1 - Week 8): Sacubitril/Valsartan Open-label Treatment Period (Week 9 - Week 16): Sacubitril/Valsartan
11294600|NCT02970669|BG002|Baseline|Total|Total of all reporting groups
11294601|NCT02970669|FG000|Participant Flow|Enalapril|"Double blind treatment epoch: Patients randomized to this arm received 1 tablet of enalapril and 1 tablet of matching placebo sacubitril/valsartan twice daily for 8 weeks. All Patients began the study on Dose Level 1 (i.e. 2.5 mg enalapril BID). Patients may have been sequentially up-titrated to achieve desired dose of Dose Level 3 (i.e. 10 mg enalapril BID). Patients not tolerating dose escalation could have been titrated down to next lower dose level.~Open-label treatment epoch: All patients entering this epoch (8 weeks) were given sacubitril/valsartan 49/51 mg BID (Dose Level 2) unless they completed the double-blind treatment epoch on enalapril Dose Level 1. Instead, these patients entered open-label epoch on Dose Level 1 of sacubitril/valsartan. Patients may have been sequentially up-titrated to achieve desired dose of Dose Level 3 of sacubitril/valsartan. Patients not tolerating dose escalation could have been titrated down to next lower dose level."
11294602|NCT02970669|FG001|Participant Flow|Sacubitril/Valsartan|"Double blind treatment epoch: Patients randomized to this arm received 1 tablet of sacubitril/valsartan and 1 tablet of matching placebo enalapril twice daily for 8 weeks. All Patients began the study on Dose Level 1 (i.e. 24/26 mg sacubitril/valsartan BID). Patients may have sequentially been up-titrated to achieve desired dose of Dose Level 3 (i.e. 97/103 mg sacubitril/valsartan BID). Patients not tolerating dose escalation could have been titrated down to next lower dose level.~Open-label treatment epoch: All patients entering this epoch (8 weeks) were given sacubitril/valsartan 49/51 mg BID (Dose Level 2) unless they completed the double-blind treatment epoch on Dose Level 1. Instead, these patients entered open-label epoch on Dose Level 1. Patients may sequentially have been up-titrated to achieve desired dose of Dose Level 3. Patients not tolerating dose escalation could have been titrated down to next lower dose level."
11294603|NCT02970669|OG000|Outcome|Enalapril|Double-blind Treatment Period (Week 1 - Week 8): Enalapril Open-label Treatment Period (Week 9 - Week 16): Sacubitril/Valsartan
11294604|NCT02970669|OG001|Outcome|Sacubitril/Valsartan|Double-blind Treatment Period (Week 1 - Week 8): Sacubitril/Valsartan Open-label Treatment Period (Week 9 - Week 16): Sacubitril/Valsartan
11294605|NCT02970669|EG000|Reported Event|Enalapril (Randomized Treatment Period)|Week 1 to Week 8: Enalapril
11294606|NCT02970669|EG001|Reported Event|Sacubitril/Valsartan (Randomized Treatment Period)|Week 1 to Week 8: Sacubitril/Valsartan
11294607|NCT02970669|EG002|Reported Event|Enalapril (Open-Label Extension Period)|Week 9 - 16: Sacubitril/Valsartan
11294608|NCT02970669|EG003|Reported Event|Sacubitril/Valsartan (Open-Label Extension Period)|Week 9 - 16: Sacubitril/Valsartan
11294609|NCT02970812|BG000|Baseline|Electrical Muscle Stimulation|"EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.~EMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294610|NCT02970812|BG001|Baseline|Electrical Nerve Stimulation|"Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.~TENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294611|NCT02970812|BG002|Baseline|Total|Total of all reporting groups
11294612|NCT02970812|FG000|Participant Flow|Electrical Muscle Stimulation|"EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.~EMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294613|NCT02970812|FG001|Participant Flow|Electrical Nerve Stimulation|"Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.~TENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294614|NCT02970812|OG000|Outcome|Electrical Muscle Stimulation|"EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.~EMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294615|NCT02970812|OG001|Outcome|Electrical Nerve Stimulation|"Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.~TENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294616|NCT02970812|EG000|Reported Event|Electrical Muscle Stimulation|"EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.~EMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294617|NCT02970812|EG001|Reported Event|Electrical Nerve Stimulation|"Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.~TENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."
11294618|NCT02970942|BG000|Baseline|Semaglutide 0.1 mg|Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
11294619|NCT02970942|BG001|Baseline|Semaglutide 0.2 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
11294620|NCT02970942|BG002|Baseline|Semaglutide 0.4 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
11294621|NCT02970942|BG003|Baseline|Placebo|Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
11294622|NCT02970942|BG004|Baseline|Total|Total of all reporting groups
11294623|NCT02970942|FG000|Participant Flow|Semaglutide 0.1 mg|Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
11294624|NCT02970942|FG001|Participant Flow|Semaglutide 0.2 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
11294625|NCT02970942|FG002|Participant Flow|Semaglutide 0.4 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
11294626|NCT02970942|FG003|Participant Flow|Placebo|Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
10971117|NCT00914069|EG001|Reported Event|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
11294627|NCT02970942|OG000|Outcome|Semaglutide 0.1 mg|Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
11294628|NCT02970942|OG001|Outcome|Semaglutide 0.2 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
11294629|NCT02970942|OG002|Outcome|Semaglutide 0.4 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
11294630|NCT02970942|OG003|Outcome|Placebo|Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
11294631|NCT02970942|EG000|Reported Event|Semaglutide 0.1 mg|Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
11294632|NCT02970942|EG001|Reported Event|Semaglutide 0.2 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
11294633|NCT02970942|EG002|Reported Event|Semaglutide 0.4 mg|Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
11294634|NCT02970942|EG003|Reported Event|Placebo|Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
11294635|NCT02971007|BG000|Baseline|CAMB 200 mg|"200 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
11294636|NCT02971007|BG001|Baseline|CAMB 400 mg|"400 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
11294637|NCT02971007|BG002|Baseline|Fluconazole 150 mg|"Fluconazole Diflucan~Fluconazole"
11294638|NCT02971007|BG003|Baseline|Total|Total of all reporting groups
11294639|NCT02971007|FG000|Participant Flow|CAMB 200 mg|"200 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
10971118|NCT00914186|BG000|Baseline|Vehicle|once daily
11294640|NCT02971007|FG001|Participant Flow|CAMB 400 mg|"400 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
11294641|NCT02971007|FG002|Participant Flow|Fluconazole 150 mg|"Fluconazole Diflucan~Fluconazole"
11294642|NCT02971007|OG000|Outcome|CAMB 200 mg|"200 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
11294643|NCT02971007|OG001|Outcome|CAMB 400 mg|"400 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
11294644|NCT02971007|OG002|Outcome|Fluconazole 150 mg|"Fluconazole Diflucan~Fluconazole"
11294645|NCT02971007|EG000|Reported Event|CAMB 200 mg|"200 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
10848231|NCT00289185|OG001|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
11216733|NCT02308748|FG008|Participant Flow|B-E-C-A-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem)"
11216734|NCT02308748|FG009|Participant Flow|C-B-D-E-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment A (dofetilide)"
11216735|NCT02308748|OG000|Outcome|Dofetilide Alone|Subjects that completed placebo and dofetilide alone interventions
11216736|NCT02308748|OG001|Outcome|Dofetilide + Mexiletine|Subjects that completed placebo and dofetilide + mexiletine interventions
11216737|NCT02308748|OG002|Outcome|Dofetilide + Lidocaine|Subjects that completed placebo and dofetilide + lidocaine interventions
11216738|NCT02308748|OG000|Outcome|Moxifloxacin Alone|Subjects that completed placebo and moxifloxacin alone interventions
11216739|NCT02308748|OG001|Outcome|Moxifloxacin + Diltiazem|Subjects that completed placebo and moxifloxacin + diltiazem interventions
11216740|NCT02308748|EG000|Reported Event|Dofetilide|"Dofetilide alone arm~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg"
11216741|NCT02308748|EG001|Reported Event|Dofetilide + Lidocaine|"Dofetilide combined with lidocaine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Lidocaine: • 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes~2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes~7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
11216742|NCT02308748|EG002|Reported Event|Dofetilide + Mexiletine|"Dofetilide combined with mexiletine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Mexiletine: • 8 am: weight x 4 mg/kg~12 pm (noon): Same as at 8 am~5:30 pm: Same as at 8 am"
11216743|NCT02308748|EG003|Reported Event|Moxifloxacin + Diltiazem|"Moxifloxacin with and without diltiazem.~Moxifloxacin: • 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)~2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~Diltiazem: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes"
11216744|NCT02308748|EG004|Reported Event|Placebo|"Placebo (#2 gelcap and intravenous saline)~Placebo: Placebo (#2 Gelcap or IV saline)"
11216745|NCT02308787|BG000|Baseline|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11216746|NCT02308787|FG000|Participant Flow|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11216747|NCT02308787|OG000|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11216748|NCT02308787|EG000|Reported Event|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11216749|NCT02308839|BG000|Baseline|GORE® EXCLUDER® AAA Endoprosthesis|GORE® EXCLUDER® AAA Endoprosthesis
11216750|NCT02308839|FG000|Participant Flow|GORE® EXCLUDER® AAA Endoprosthesis|GORE® EXCLUDER® AAA Endoprosthesis
11216751|NCT02308839|OG000|Outcome|GORE® EXCLUDER® AAA Endoprosthesis|GORE® EXCLUDER® AAA Endoprosthesis
11216752|NCT02308839|EG000|Reported Event|GORE® EXCLUDER® AAA Endoprosthesis|GORE® EXCLUDER® AAA Endoprosthesis Registry conducted for reimbursement in France, and no MedDRA coding was required.
11216753|NCT02309099|BG000|Baseline|Vestibular Schwannoma|Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.
11216754|NCT02309099|BG001|Baseline|Meniere's Disease|Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
11216755|NCT02309099|BG002|Baseline|Total|Total of all reporting groups
11216756|NCT02309099|FG000|Participant Flow|Vestibular Schwannoma|Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.
11216757|NCT02309099|FG001|Participant Flow|Meniere's Disease|Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
11216758|NCT02309099|OG000|Outcome|Vestibular Schwannoma|Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.
11216759|NCT02309099|OG001|Outcome|Meniere's Disease|Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
11216760|NCT02309099|EG000|Reported Event|Vestibular Schwannoma|Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.
11216761|NCT02309099|EG001|Reported Event|Meniere's Disease|Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
11294646|NCT02971007|EG001|Reported Event|CAMB 400 mg|"400 mg CAMB (MAT2203) Oral Amphotericin B~Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B"
10848232|NCT00289185|EG000|Reported Event|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10971119|NCT00914186|BG001|Baseline|TS-022 0.005%|lotion/once daily
11216762|NCT02309112|BG000|Baseline|Yoga Group A: Minimum Exposure|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216763|NCT02309112|BG001|Baseline|Yoga Group B: Medium Exposure|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216764|NCT02309112|BG002|Baseline|Yoga Group C: Maximum Exposure|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216765|NCT02309112|BG003|Baseline|Total|Total of all reporting groups
11216766|NCT02309112|FG000|Participant Flow|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216767|NCT02309112|FG001|Participant Flow|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216768|NCT02309112|FG002|Participant Flow|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216769|NCT02309112|OG000|Outcome|Eligible Participants|The group of eligible participants who agreed to be randomized to ono of three yoga groups.
11216770|NCT02309112|OG000|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11216771|NCT02309112|OG001|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11216772|NCT02309112|OG002|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
11216773|NCT02309112|OG002|Outcome|Yoga Group C: Maximum Exposure|"Maximum Yoga Dose~Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)"
11294647|NCT02971007|EG002|Reported Event|Fluconazole 150 mg|"Fluconazole Diflucan~Fluconazole"
11332595|NCT03497845|OG002|Outcome|c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11294648|NCT02971163|BG000|Baseline|SynDA|"The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.~SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider."
11294649|NCT02971163|BG001|Baseline|Control|Patients in the control arm will receive usual emergency care pertaining to syncope.
11294650|NCT02971163|BG002|Baseline|Total|Total of all reporting groups
11294651|NCT02971163|FG000|Participant Flow|SynDA|"The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.~SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider."
11294652|NCT02971163|FG001|Participant Flow|Control|Patients in the control arm will receive usual emergency care pertaining to syncope.
11294653|NCT02971163|OG000|Outcome|SynDA|"The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.~SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider."
11294654|NCT02971163|OG001|Outcome|Control|Patients in the control arm will receive usual emergency care pertaining to syncope.
11294655|NCT02971163|EG000|Reported Event|SynDA|"The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.~SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider."
10848233|NCT00289185|EG001|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
11294656|NCT02971163|EG001|Reported Event|Control|Patients in the control arm will receive usual emergency care pertaining to syncope.
11294657|NCT02971202|BG000|Baseline|Hyperinsulinemic, Euglycemic Clamp: T1DM|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 milliunit (mU)/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294658|NCT02971202|BG001|Baseline|Hyperinsulinemic, Euglycemic Clamp:MODY2|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294659|NCT02971202|BG002|Baseline|Hyperinsulinemic Euglycemic Clamp:Control|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294660|NCT02971202|BG003|Baseline|Total|Total of all reporting groups
11294661|NCT02971202|FG000|Participant Flow|Hyperinsulinemic, Euglycemic Clamp: T1DM|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 milliunit (mU)/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11332596|NCT03497845|OG003|Outcome|d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10971120|NCT00914186|BG002|Baseline|TS-022 0.010%|lotion/once daily
11294662|NCT02971202|FG001|Participant Flow|Hyperinsulinemic, Euglycemic Clamp:MODY2|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294663|NCT02971202|FG002|Participant Flow|Hyperinsulinemic Euglycemic Clamp:Control|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294664|NCT02971202|OG000|Outcome|Hyperinsulinemic, Euglycemic Clamp: T1DM|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 milliunit (mU)/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294665|NCT02971202|OG001|Outcome|Hyperinsulinemic, Euglycemic Clamp:MODY2|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294666|NCT02971202|OG002|Outcome|Hyperinsulinemic Euglycemic Clamp:Control|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294667|NCT02971202|EG000|Reported Event|Hyperinsulinemic, Euglycemic Clamp: T1DM|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 milliunit (mU)/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294668|NCT02971202|EG001|Reported Event|Hyperinsulinemic, Euglycemic Clamp:MODY2|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
11294669|NCT02971202|EG002|Reported Event|Hyperinsulinemic Euglycemic Clamp:Control|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts.~A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study."
10971121|NCT00914186|BG003|Baseline|TS-022 0.020%|lotion/once daily
10971122|NCT00914186|BG004|Baseline|Total|Total of all reporting groups
10971123|NCT00914186|FG000|Participant Flow|Vehicle|once daily
10971124|NCT00914186|FG001|Participant Flow|TS-022 0.005%|lotion/once daily
11294670|NCT02971228|BG000|Baseline|Part 1, All Participants|"In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. Note: 13 patients were enrolled and 1 patient withdrew prior to treatment with either trial drug; thus, 12 patients were randomized and treated.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294671|NCT02971228|FG000|Participant Flow|Part 1 Lilly Glucagon or ZP4207|1 patient was enrolled but withdrew prior to treatment with either trial drug
11294672|NCT02971228|FG001|Participant Flow|Part 1, Lilly Glucagon Then ZP4207|"7 patients received Lilly Glucagon then ZP4207 in this treatment sequence (2 withdrew before receiving ZP4207). Insulin Lispro was also administered in both treatment arms.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.~iPhone-based bionic pancreas: An experimental device."
11294673|NCT02971228|FG002|Participant Flow|Part 1, ZP4207 Then Lilly Glucagon|"5 patients received ZP4207 then Lilly Glucagon in this treatment sequence. Insulin Lispro was also administered in both treatment arms.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.~iPhone-based bionic pancreas: An experimental device."
11294674|NCT02971228|FG003|Participant Flow|Part 2, ZP4207 Then Lilly Glucagon|Part 2 of the trial was not conducted - see above.
11294675|NCT02971228|FG004|Participant Flow|Part 2, Lilly Glucagon Then ZP4207|Part 2 of the trial was not conducted - see above.
11294676|NCT02971228|OG000|Outcome|Part 1, ZP4207|"In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294677|NCT02971228|OG001|Outcome|Part 1, Lilly Glucagon|"In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294678|NCT02971228|OG000|Outcome|Part 1, ZP4207|"In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294679|NCT02971228|OG001|Outcome|Part 1, Lilly Glucagon|"In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294680|NCT02971228|OG000|Outcome|Part 1, ZP4207|"In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
10971125|NCT00914186|FG002|Participant Flow|TS-022 0.010%|lotion/once daily
10971126|NCT00914186|FG003|Participant Flow|TS-022 0.020%|lotion/once daily
10971127|NCT00914186|OG000|Outcome|Vehicle|once daily
11294681|NCT02971228|OG001|Outcome|Part 1, Lilly Glucagon|"In Part 1, 12 patients received treatment with Lilly glucagon with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294682|NCT02971228|OG001|Outcome|Part 1, Lilly Glucagon|"In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294683|NCT02971228|EG000|Reported Event|Part 1, ZP4207|"In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294684|NCT02971228|EG001|Reported Event|Part 1, Lilly Glucagon|"In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.~Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.~Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.~iPhone-based bionic pancreas: An experimental device."
11294685|NCT02971293|BG000|Baseline|Overall Study Population|Full analysis set: All randomised participants who received at least one dose of investigational product.
11294686|NCT02971293|FG000|Participant Flow|All Participants|"All subjects received AZD8871 100 µg, AZD8871 600 µg or placebo, once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.~Each subject was randomized to one of three sequences in a 3-way, complete crossover William's design, and received all 3 treatments in turn, in three 14-day treatment periods, each (except the last one) followed by a wash-out period of 28-35 days."
11294687|NCT02971293|OG000|Outcome|AZD8871 100 µg|The subjects received AZD8871 100 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
11294688|NCT02971293|OG001|Outcome|AZD8871 600 µg|The subjects received AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
11294689|NCT02971293|OG002|Outcome|Placebo|The placebo was administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient received one inhaled dose from placebo DPI provided to him/her on each day of the treatment period.
11294690|NCT02971293|EG000|Reported Event|AZD8871 100 µg|The subjects received AZD8871 100 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
11294691|NCT02971293|EG001|Reported Event|AZD8871 600 µg|The subjects received AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
11294692|NCT02971293|EG002|Reported Event|Placebo|The placebo was administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient received one inhaled dose from placebo DPI provided to him/her on each day of the treatment period.
11294693|NCT02971488|BG000|Baseline|Persons Who Inject Drugs (PWID)|"The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed.~Screening for hepatitis C virus (HCV) in PWID and Linkage-To-Care: Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy.~Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population."
11294694|NCT02971488|FG000|Participant Flow|Total Patients|All the patients in the study
11294695|NCT02971488|OG000|Outcome|Participatnts With an Active HCV Infection|Participants who had tested positive for hepatitis C (Positive PCR).
11294696|NCT02971488|OG000|Outcome|HCV Infected Patients|Those with an active HCV infection
11294697|NCT02971488|OG001|Outcome|Patients Who Started HCV Therapy|HCV infected Patients who started treatment with antivirals
11294698|NCT02971488|OG000|Outcome|Total Patients|All the patients in the study
11294699|NCT02971488|EG000|Reported Event|Total Patients|All the patients in the study
11294700|NCT02971605|BG000|Baseline|Psilocybin|"Participants will be administered a 25 mg/70 kg dose of psilocybin~Psilocybin: 25 mg/70 kg Psilocybin"
11294701|NCT02971605|FG000|Participant Flow|Psilocybin|"Participants will be administered a 25 mg/70 kg dose of psilocybin~Psilocybin: 25 mg/70 kg Psilocybin"
11294702|NCT02971605|OG000|Outcome|Baseline|One day prior to psilocybin administration.
11294703|NCT02971605|OG001|Outcome|1-week Post Session|One week post psilocybin (25 mg/70 kg) administration.
11294704|NCT02971605|OG002|Outcome|1-month Post Session|One month post psilocybin (25 mg/70 kg) administration.
11294705|NCT02971605|EG000|Reported Event|Psilocybin|"Participants will be administered a 25 mg/70 kg dose of psilocybin~Psilocybin: 25 mg/70 kg Psilocybin"
11294706|NCT02971631|BG000|Baseline|All Participants|All participants were randomised to reveal both interventions, so baseline characteristics are reported for the whole study population.
11294707|NCT02971631|FG000|Participant Flow|Placebo Then Exendin|Infusion of 1% human albumin in normal saline on day one of study. Infusion of Exendin 9-39 in 1% human albumin in normal saline on day two of study (bolus of 7500pmol/kg followed by infusion of 500pmol/kg/minute for 4 hours).
11294708|NCT02971631|FG001|Participant Flow|Exendin Then Placebo|"Infusion of Exendin 9-39 in 1% human albumin in normal saline on day one of study (bolus of 7500pmol/kg followed by infusion of 500pmol/kg/minute for 4 hours).~Infusion of 1% human albumin in normal saline on day two of study."
11294709|NCT02971631|OG000|Outcome|Placebo|"Infusion of 1% human albumin in normal saline.~Placebo: Infusion of 1% human albumin in normal saline"
11294710|NCT02971631|OG001|Outcome|Exendin|"Infusion of Exendin 9-39 in 1% human albumin in normal saline~Exendin 9-39: Complete blockade of action of endogenous GLP-1 by Exendin 9-39."
11294711|NCT02971631|OG001|Outcome|Exendin|"Infusion of Exendin 9-39 in 1% human albumin in normal saline~Exendin 9-39: Complete blockade of action of endogenous GLP-1 by Exendin 9-39. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA)."
11294712|NCT02971631|EG000|Reported Event|Placebo|"Infusion of 1% human albumin in normal saline.~Placebo: Infusion of 1% human albumin in normal saline"
11294713|NCT02971631|EG001|Reported Event|Exendin|"Infusion of Exendin 9-39 in 1% human albumin in normal saline~Exendin 9-39: Complete blockade of action of endogenous GLP-1 by Exendin 9-39."
10848234|NCT00289198|BG000|Baseline|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11294714|NCT02971670|BG000|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294715|NCT02971670|BG001|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294716|NCT02971670|BG002|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294717|NCT02971670|BG003|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294718|NCT02971670|BG004|Baseline|Total|Total of all reporting groups
11294719|NCT02971670|FG000|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294720|NCT02971670|FG001|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294721|NCT02971670|FG002|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294722|NCT02971670|FG003|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294723|NCT02971670|OG000|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294724|NCT02971670|OG001|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294725|NCT02971670|OG002|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294726|NCT02971670|OG003|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294727|NCT02971670|EG000|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294728|NCT02971670|EG001|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294729|NCT02971670|EG002|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
11294730|NCT02971670|EG003|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I."
10971128|NCT00914186|OG001|Outcome|TS-022 0.005%|lotion/once daily
10971129|NCT00914186|OG002|Outcome|TS-022 0.010%|lotion/once daily
10971130|NCT00914186|OG003|Outcome|TS-022 0.020%|lotion/once daily
10971131|NCT00914186|OG001|Outcome|TS-022|lotion/once daily
10971132|NCT00914186|EG000|Reported Event|Vehicle|once daily
10971133|NCT00914186|EG001|Reported Event|TS-022 0.005%|lotion/once daily
10971134|NCT00914186|EG002|Reported Event|TS-022 0.010%|lotion/once daily
10971135|NCT00914186|EG003|Reported Event|TS-022 0.020%|lotion/once daily
11294731|NCT02971735|BG000|Baseline|Interactive Multimedia Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294732|NCT02971735|BG001|Baseline|Power Point Show Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294733|NCT02971735|BG002|Baseline|Total|Total of all reporting groups
11294734|NCT02971735|FG000|Participant Flow|Interactive Multimedia Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294735|NCT02971735|FG001|Participant Flow|Power Point Show Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294736|NCT02971735|OG000|Outcome|Interactive Multimedia Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294737|NCT02971735|OG001|Outcome|Power Point Show Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294738|NCT02971735|EG000|Reported Event|Interactive Multimedia Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294739|NCT02971735|EG001|Reported Event|Power Point Show Module|"Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.~mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module."
11294740|NCT02971800|BG000|Baseline|Sodium Fluorescein|"Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.~Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once~sodium fluorescein injection 10%"
11294741|NCT02971800|FG000|Participant Flow|Sodium Fluorescein|"Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.~Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once~sodium fluorescein injection 10%"
11294742|NCT02971800|OG000|Outcome|Sodium Fluorescein|"Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.~Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once~sodium fluorescein injection 10%"
11294743|NCT02971800|EG000|Reported Event|Sodium Fluorescein|"Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.~Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once~sodium fluorescein injection 10%"
11294744|NCT02972242|BG000|Baseline|Modified Field of View|"In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294745|NCT02972242|BG001|Baseline|Standard Field of View|"In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294746|NCT02972242|BG002|Baseline|Total|Total of all reporting groups
11294747|NCT02972242|FG000|Participant Flow|Modified Field of View|"In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294748|NCT02972242|FG001|Participant Flow|Standard Field of View|"In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294749|NCT02972242|OG000|Outcome|Modified Field of View|"In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294750|NCT02972242|OG001|Outcome|Standard Field of View|"In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294751|NCT02972242|EG000|Reported Event|Modified Field of View|"In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294752|NCT02972242|EG001|Reported Event|Standard Field of View|"In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.~Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography"
11294753|NCT02972359|BG000|Baseline|Neridronic Acid|"Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.~Neridronic acid: Neridronic acid administered as intravenous infusion."
11294754|NCT02972359|FG000|Participant Flow|Neridronic Acid|Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg as intravenous infusion.
11294755|NCT02972359|OG000|Outcome|Neridronic Acid|"Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.~Neridronic acid: Neridronic acid administered as intravenous infusion."
11294756|NCT02972359|EG000|Reported Event|Neridronic Acid|"Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.~Neridronic acid: Neridronic acid administered as intravenous infusion."
11294757|NCT02972502|BG000|Baseline|Metoclopramide (Reglan)|"Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294758|NCT02972502|BG001|Baseline|Haloperidol (Haldol)|"Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Haloperidol: Patients receive 2.5 mg of IV haloperidol.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294759|NCT02972502|BG002|Baseline|Total|Total of all reporting groups
10848235|NCT00289198|BG001|Baseline|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
10848236|NCT00289198|BG002|Baseline|Total|Total of all reporting groups
10848237|NCT00289198|FG000|Participant Flow|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11294760|NCT02972502|FG000|Participant Flow|Metoclopramide (Reglan)|"Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294761|NCT02972502|FG001|Participant Flow|Haloperidol (Haldol)|"Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Haloperidol: Patients receive 2.5 mg of IV haloperidol.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294762|NCT02972502|OG000|Outcome|Metoclopramide (Reglan)|"Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294763|NCT02972502|OG001|Outcome|Haloperidol (Haldol)|"Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Haloperidol: Patients receive 2.5 mg of IV haloperidol.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294764|NCT02972502|EG000|Reported Event|Metoclopramide (Reglan)|"Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294765|NCT02972502|EG001|Reported Event|Haloperidol (Haldol)|"Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.~Haloperidol: Patients receive 2.5 mg of IV haloperidol.~Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)~Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine."
11294766|NCT02972515|BG000|Baseline|See Me Smoke-Free|"Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app most days for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.~See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.~Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone"
11294767|NCT02972515|FG000|Participant Flow|See Me Smoke-Free|"Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app most days for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.~See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.~Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone"
11294768|NCT02972515|OG000|Outcome|See Me Smoke-Free|"Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app most days for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.~See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.~Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone"
11294769|NCT02972515|EG000|Reported Event|See Me Smoke-Free|"Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app most days for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.~See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.~Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone"
11294770|NCT02972554|BG000|Baseline|Propanolol Hydrochloride|This is the experimental group given the beta-blocker, propanolol hydrochloride with a 40mg single tablet dosage.
11294771|NCT02972554|BG001|Baseline|Placebo|This is the control group given a placebo, which was a placebo-matching active drug single dosage.
11294772|NCT02972554|BG002|Baseline|Total|Total of all reporting groups
11294773|NCT02972554|FG000|Participant Flow|Propanolol Hydrochloride|This is the experimental group given the beta-blocker, propanolol hydrochloride with a single 40mg tablet dosage.
10848238|NCT00289198|FG001|Participant Flow|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11294774|NCT02972554|FG001|Participant Flow|Placebo|This is the control group given a placebo, which was a single placebo-matching active drug dose.
11294775|NCT02972554|OG000|Outcome|Propanolol Hydrochloride|This is the experimental group given the beta-blocker, propanolol hydrochloride using a 40mg single tablet dosage.
11294776|NCT02972554|OG001|Outcome|Placebo|This is the control group given a placebo, which was a placebo-matching active drug
11294777|NCT02972554|EG000|Reported Event|Propanolol Hydrochloride|This is the experimental group given the beta-blocker propanolol hydrochloride. All subjects in this group received a single dose of 40mg of propanolol in a single tablet.
11294778|NCT02972554|EG001|Reported Event|Placebo|This is the control group given a placebo. All subjects in this group received a single dose of the placebo in a single tablet.
11294779|NCT02972632|BG000|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
11294780|NCT02972632|FG000|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
11294781|NCT02972632|OG000|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
11294782|NCT02972632|EG000|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
11294783|NCT02972658|BG000|Baseline|AZES Placebo/AZFD Lanabecestat 20 mg|Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
11294784|NCT02972658|BG001|Baseline|AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg|Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
11294785|NCT02972658|BG002|Baseline|AZES Placebo/AZFD Lanabecestat 50 mg|Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
11294786|NCT02972658|BG003|Baseline|AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg|Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
11294787|NCT02972658|BG004|Baseline|Total|Total of all reporting groups
11294788|NCT02972658|FG000|Participant Flow|AZES Placebo/AZFD Lanabecestat 20 mg|Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
11294789|NCT02972658|FG001|Participant Flow|AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg|Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
11294790|NCT02972658|FG002|Participant Flow|AZES Placebo/AZFD Lanabecestat 50 mg|Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
11294791|NCT02972658|FG003|Participant Flow|AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg|Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
11294792|NCT02972658|OG000|Outcome|AZES Placebo/AZFD Lanabecestat 20 mg|Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
11294793|NCT02972658|OG001|Outcome|AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg|Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
11294794|NCT02972658|OG002|Outcome|AZES Placebo/AZFD Lanabecestat 50 mg|Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
11294795|NCT02972658|OG003|Outcome|AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg|Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
11294796|NCT02972658|EG000|Reported Event|AZES Placebo/AZFD Lanabecestat 20 mg|Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
11294797|NCT02972658|EG001|Reported Event|AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg|Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
11294798|NCT02972658|EG002|Reported Event|AZES Placebo/AZFD Lanabecestat 50 mg|Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
11294799|NCT02972658|EG003|Reported Event|AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg|Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
11294800|NCT02973048|BG000|Baseline|Hyperbaric Bupivacaine|"Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294801|NCT02973048|BG001|Baseline|Hyperbaric Prilocaine|"Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294802|NCT02973048|BG002|Baseline|Total|Total of all reporting groups
11294803|NCT02973048|FG000|Participant Flow|Hyperbaric Bupivacaine|"Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294804|NCT02973048|FG001|Participant Flow|Hyperbaric Prilocaine|"Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294805|NCT02973048|OG000|Outcome|Hyperbaric Bupivacaine|"Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
10971136|NCT00914316|BG000|Baseline|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
10971137|NCT00914316|BG001|Baseline|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
11216774|NCT02309112|EG000|Reported Event|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216775|NCT02309112|EG001|Reported Event|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216776|NCT02309112|EG002|Reported Event|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11216777|NCT02309138|BG000|Baseline|3 Hour 100 gm OGTT (CC Criteria)|"Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.~Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test"
11216778|NCT02309138|BG001|Baseline|2 hr 75 gm OGTT (IADPSG Criteria)|"Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.~Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test"
11216779|NCT02309138|BG002|Baseline|Total|Total of all reporting groups
11216780|NCT02309138|FG000|Participant Flow|3 Hour 100 gm OGTT (CC Criteria)|"Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.~Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test"
11216781|NCT02309138|FG001|Participant Flow|2 hr 75 gm OGTT (IADPSG Criteria)|"Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the International Association of the Diabetes in Pregnancy Study Group (IADPSG) which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.~Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test"
11216782|NCT02309138|OG000|Outcome|Overall IADPSG Arm|Participants randomized into the IADPSG arm
11216783|NCT02309138|OG001|Outcome|Overall Carpenter Coustan|Participants randomized in the the Carpenter Coustan arm
11216784|NCT02309138|OG002|Outcome|IADPSG With no GDM|Participants diagnosed as having no GDM by the IADPSG criteria.
11216785|NCT02309138|OG003|Outcome|Carpenter Coustan With no GDM|Participants diagnosed as having no GDM by the Carpenter Coustan criteria
11216786|NCT02309138|OG001|Outcome|Overall Carpentar-Coustan Arm|Participants randomized in the the Carpenter Coustan arm
11216787|NCT02309138|OG002|Outcome|IADPSG Criteria w/ No GDM|"Participants randomized in the the IADPSG arm w No GDM classification"
11216788|NCT02309138|OG003|Outcome|CC Criteria w/ No GDM|"Participants randomized in the the Carpenter Coustan arm w/ No GDM classification"
11216789|NCT02309138|OG003|Outcome|Carpenter Coustan With no GDM|Participants diagnosed as having no GDM by the CC criteria
11216790|NCT02309138|OG000|Outcome|2 hr 75 gm OGTT (IADPSG Criteria)|"Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.~Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test"
11294806|NCT02973048|OG001|Outcome|Hyperbaric Prilocaine|"Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294807|NCT02973048|EG000|Reported Event|Hyperbaric Bupivacaine|"Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294808|NCT02973048|EG001|Reported Event|Hyperbaric Prilocaine|"Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.~Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points."
11294809|NCT02973087|BG000|Baseline|Prior On-demand Participants|Participants who had taken only on-demand VWF prior to the current study received rVWF (vonicog alpha) initial prophylactic treatment at a dose range of 50 +/- 10 IU/kg, intravenous infusion, twice per week for a planned period of 12 months. Dose escalation to higher dose (up to 80 IU/kg per infusion) or frequency (up to 3 times a week) was based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294810|NCT02973087|BG001|Baseline|Switch Participants|Participants who had taken prophylactic treatment with pdVWF prior to current study and switched to prophylaxis with rVWF (vonicog alpha) during the study for a planned period of 12 months; received rVWF twice weekly at an initial prophylactic dose of +/- 10 percent (%) of VWF in the pdVWF weekly dose received prior to this study. Dosing with rVWF up to 80 IU/kg per infusion or at a frequency up to 3 times a week or once a week were allowed depending on the total weekly dose and the dosing regimen used in their previous pdVWF prophylaxis regimen and based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294811|NCT02973087|BG002|Baseline|Total|Total of all reporting groups
11294812|NCT02973087|FG000|Participant Flow|Prior On-demand Participants|Participants who had taken only on-demand von Willebrand factor (VWF) prior to the current study received rVWF (vonicog alpha) initial prophylactic treatment at a dose range of 50 plus minus (+/- ) 10 international unit per kilogram (IU/kg), intravenous infusion, twice per week for a planned period of 12 months. Dose escalation to higher dose (up to 80 IU/kg per infusion) or frequency (up to 3 times a week) was based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (recombinant Factor VIII [rFVIII]); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294813|NCT02973087|FG001|Participant Flow|Switch Participants|Participants who had taken prophylactic treatment with plasma derived VWF product (pdVWF) prior to current study and switched to prophylaxis with rVWF (vonicog alpha) during the study for a planned period of 12 months; received rVWF twice weekly at an initial prophylactic dose of +/- 10 percent (%) of VWF in the pdVWF weekly dose received prior to this study. Dosing with rVWF up to 80 IU/kg per infusion or at a frequency up to 3 times a week or once a week were allowed depending on the total weekly dose and the dosing regimen used in their previous pdVWF prophylaxis regimen and based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294814|NCT02973087|OG000|Outcome|Prior On-demand Participants|Participants who had taken only on-demand VWF prior to the current study received rVWF (vonicog alpha) initial prophylactic treatment at a dose range of 50 +/- 10 IU/kg, intravenous infusion, twice per week for a planned period of 12 months. Dose escalation to higher dose (up to 80 IU/kg per infusion) or frequency (up to 3 times a week) was based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294815|NCT02973087|OG001|Outcome|Switch Participants|Participants who had taken prophylactic treatment with pdVWF prior to current study and switched to prophylaxis with rVWF (vonicog alpha) during the study for a planned period of 12 months; received rVWF twice weekly at an initial prophylactic dose of +/- 10 percent (%) of VWF in the pdVWF weekly dose received prior to this study. Dosing with rVWF up to 80 IU/kg per infusion or at a frequency up to 3 times a week or once a week were allowed depending on the total weekly dose and the dosing regimen used in their previous pdVWF prophylaxis regimen and based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294816|NCT02973087|OG000|Outcome|Switch Participants|Participants who had taken prophylactic treatment with pdVWF prior to current study and switched to prophylaxis with rVWF (vonicog alpha) during the study for a planned period of 12 months; received rVWF twice weekly at an initial prophylactic dose of +/- 10 percent (%) of VWF in the pdVWF weekly dose received prior to this study. Dosing with rVWF up to 80 IU/kg per infusion or at a frequency up to 3 times a week or once a week were allowed depending on the total weekly dose and the dosing regimen used in their previous pdVWF prophylaxis regimen and based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294817|NCT02973087|EG000|Reported Event|Prior On-demand Participants|Participants who had taken only on-demand VWF prior to the current study received rVWF (vonicog alpha) initial prophylactic treatment at a dose range of 50 +/- 10 IU/kg, intravenous infusion, twice per week for a planned period of 12 months. Dose escalation to higher dose (up to 80 IU/kg per infusion) or frequency (up to 3 times a week) was based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294818|NCT02973087|EG001|Reported Event|Switch Participants|Participants who had taken prophylactic treatment with pdVWF prior to current study and switched to prophylaxis with rVWF (vonicog alpha) during the study for a planned period of 12 months; received rVWF twice weekly at an initial prophylactic dose of +/- 10 percent (%) of VWF in the pdVWF weekly dose received prior to this study. Dosing with rVWF up to 80 IU/kg per infusion or at a frequency up to 3 times a week or once a week were allowed depending on the total weekly dose and the dosing regimen used in their previous pdVWF prophylaxis regimen and based on medical indication and investigator judgment. During this prophylactic treatment period, any breakthrough bleeding episodes requiring replacement therapy with VWF concentrate was treated with rVWF with or without ADVATE (rFVIII); the dose was determined according to the bleeding type and severity, and was adjusted based on the participant's clinical response.
11294819|NCT02973100|BG000|Baseline|Placebo|Participants received placebo once weekly (QW) by subcutaneous (SC) injection.
11294820|NCT02973100|BG001|Baseline|Dulaglutide 1.5mg|Participants received 1.5mg of dulaglutide QW by SC injection.
11294821|NCT02973100|BG002|Baseline|Dulaglutide 3.0mg|Participants received 3.0mg of dulaglutide QW by SC injection.
11294822|NCT02973100|BG003|Baseline|Dulaglutide 4.5mg|Participants received 4.5mg of dulaglutide QW by SC injection.
11294823|NCT02973100|BG004|Baseline|Total|Total of all reporting groups
11294824|NCT02973100|FG000|Participant Flow|Placebo|Participants received placebo once weekly (QW) by subcutaneous (SC) injection.
11294825|NCT02973100|FG001|Participant Flow|Dulaglutide 1.5 Milligrams (mg)|Participants received 1.5mg of dulaglutide QW by SC injection.
11294826|NCT02973100|FG002|Participant Flow|Dulaglutide 3.0mg|Participants received 3.0mg of dulaglutide QW by SC injection.
11294827|NCT02973100|FG003|Participant Flow|Dulaglutide 4.5mg|Participants received 4.5mg of dulaglutide QW by SC injection.
11294828|NCT02973100|OG000|Outcome|Placebo|Participants received placebo once weekly (QW) by subcutaneous (SC) injection.
11294829|NCT02973100|OG001|Outcome|Dulaglutide 1.5mg|Participants received 1.5mg of dulaglutide QW by SC injection.
11294830|NCT02973100|OG002|Outcome|Dulaglutide 3.0mg|Participants received 3.0mg of dulaglutide QW by SC injection.
11294831|NCT02973100|OG003|Outcome|Dulaglutide 4.5mg|Participants received 4.5mg of dulaglutide QW by SC injection.
11294832|NCT02973100|OG000|Outcome|Dulaglutide 1.5mg|Participants received 1.5mg of dulaglutide QW by SC injection.
11294833|NCT02973100|OG001|Outcome|Dulaglutide 3.0mg|Participants received 3.0mg of dulaglutide QW by SC injection.
11294834|NCT02973100|OG002|Outcome|Dulaglutide 4.5mg|Participants received 4.5mg of dulaglutide QW by SC injection.
11294835|NCT02973100|EG000|Reported Event|Placebo|Participants received placebo once weekly (QW) by subcutaneous (SC) injection.
11294836|NCT02973100|EG001|Reported Event|Dulaglutide 1.5mg|Participants received 1.5mg of dulaglutide QW by SC injection.
11294837|NCT02973100|EG002|Reported Event|Dulaglutide 3.0mg|Participants received 3.0mg of dulaglutide QW by SC injection.
11294838|NCT02973100|EG003|Reported Event|Dulaglutide 4.5mg|Participants received 4.5mg of dulaglutide QW by SC injection.
11294839|NCT02973438|BG000|Baseline|Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM|"This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294840|NCT02973438|BG001|Baseline|Control (CON) Intermittent Hypoxia Then SHAM|"This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294841|NCT02973438|BG002|Baseline|Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia|"This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294842|NCT02973438|BG003|Baseline|Control (CON) SHAM Then Intermittent Hypoxia|"This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294843|NCT02973438|BG004|Baseline|Total|Total of all reporting groups
11294844|NCT02973438|FG000|Participant Flow|Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM|"This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294845|NCT02973438|FG001|Participant Flow|Control (CON) Intermittent Hypoxia Then SHAM|"This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294846|NCT02973438|FG002|Participant Flow|Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia|"This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294847|NCT02973438|FG003|Participant Flow|Control (CON) SHAM Then Intermittent Hypoxia|"This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.~SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21)."
11294848|NCT02973438|OG000|Outcome|Spinal Cord Injury (SCI) Intermittent Hypoxia|This arm of individuals with SCI will receive Intermittent Hypoxia (IH). Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
11294849|NCT02973438|OG001|Outcome|Control (CON) Intermittent Hypoxia|"This arm of non injured control subjects will receive Intermittent Hypoxia (IH).~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%."
11294850|NCT02973438|OG002|Outcome|Spinal Cord Injury (SCI) SHAM|This arm of individuals with SCI will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
11294851|NCT02973438|OG003|Outcome|Control (CON) SHAM|This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
11294852|NCT02973438|OG003|Outcome|Control (CON) SHAM.|This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
11294853|NCT02973438|EG000|Reported Event|Spinal Cord Injury (SCI) Intermittent Hypoxia|This arm of individuals with SCI will receive Intermittent Hypoxia (IH). Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
11294854|NCT02973438|EG001|Reported Event|Control (CON) Intermittent Hypoxia|"This arm of non injured control subjects will receive Intermittent Hypoxia (IH).~Intermittent Hypoxia (IH): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%."
11294855|NCT02973438|EG002|Reported Event|Spinal Cord Injury (SCI) SHAM|This arm of individuals with SCI will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
11294856|NCT02973438|EG003|Reported Event|Control (CON) SHAM.|This arm of non injured control subjects will receive SHAM. SHAM: Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
11294857|NCT02973477|BG000|Baseline|First Dapagliflozin Then Glimepiride|Participants received open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294858|NCT02973477|BG001|Baseline|First Glimepiride Then Dapagliflozin|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants took open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin.
11294859|NCT02973477|BG002|Baseline|Total|Total of all reporting groups
11294860|NCT02973477|FG000|Participant Flow|First Dapagliflozin Then Glimepiride|Participants received open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294861|NCT02973477|FG001|Participant Flow|First Glimepiride Then Dapagliflozin|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants took open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin.
11294862|NCT02973477|OG000|Outcome|First Dapagliflozin Then Glimepiride|Participants took open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294863|NCT02973477|OG001|Outcome|First Glimepiride Then Dapagliflozin|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride. Patients then began a 2 week washout period where they did not take any study drugs. After the washout period, participants took open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin.
11294864|NCT02973477|OG000|Outcome|Participants Who Received Dapagliflozin Intervention|Participants received open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin, whether before or after washout.
11294865|NCT02973477|OG001|Outcome|Participants Who Received Glimepiride Intervention|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride whether before or after washout.
11294866|NCT02973477|OG000|Outcome|All Participants Who Received Dapagliflozin|Participants received open-label dapagliflozin 5 mg daily for 4 weeks and then the dose escalated gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin, whether before or after washout.
11294867|NCT02973477|OG001|Outcome|All Participants Who Received Glimiperide|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294868|NCT02973477|OG001|Outcome|All Participants Who Received Glimepiride|Participants received open-label glimepiride 2 mg daily for 4 weeks and the dose escalated gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294869|NCT02973477|EG000|Reported Event|Dapagliflozin|Participants will take open-label dapagliflozin 5 mg daily for 4 weeks and escalate the dose gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin.
11294870|NCT02973477|EG001|Reported Event|Glimepiride|Participants will take open-label glimepiride 2 mg daily for 4 weeks and escalate the dose gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.
11294871|NCT02973477|EG002|Reported Event|Not on Drug|Participants who were not on study drug, either prior to drug assignment, during washout or after ceasing taking drug prior to categorization as lost to follow up. Since all participants were definitionally present in the prior to drug assignment period, all are included here.
11332597|NCT03497845|OG004|Outcome|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332598|NCT03497845|OG005|Outcome|f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332599|NCT03497845|OG006|Outcome|g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11294872|NCT02973503|BG000|Baseline|Elbasvir/Grazoprevir|Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
11294873|NCT02973503|FG000|Participant Flow|Elbasvir/Grazoprevir|Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
11294874|NCT02973503|OG000|Outcome|Elbasvir/Grazoprevir|One group, open label study
11294875|NCT02973503|OG000|Outcome|Patients Treated With Elbasvir / Grazoprevir|All patients were treated by Elbasvir / Grazoprevir. Asthenia is one of the most important adverse event reported
11294876|NCT02973503|OG000|Outcome|Patients Treated With Elbasvir/Grazoprevir|All patients were treated by Elbasvir / Grazoprevir. Headach is one of the most important adverse event reported
11294877|NCT02973503|OG000|Outcome|Patients Treated With Elbasvir/Grazoprevir|All patients were treated by Elbasvir / Grazoprevir. Digestive disorders are one of the most important adverse event reported
11294878|NCT02973503|OG000|Outcome|Elbasvir/Grazoprevir|Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
11294879|NCT02973503|OG000|Outcome|Elbasvir/Grazoprevir|Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
11294880|NCT02973503|EG000|Reported Event|Elbasvir/Grazoprevir|Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
10971138|NCT00914316|BG002|Baseline|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
11294881|NCT02973516|BG000|Baseline|Cohort 1|Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294882|NCT02973516|BG001|Baseline|Cohort 2|Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294883|NCT02973516|BG002|Baseline|Total|Total of all reporting groups
11294884|NCT02973516|FG000|Participant Flow|Cohort 1|Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294885|NCT02973516|FG001|Participant Flow|Cohort 2|Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
10848239|NCT00289198|OG000|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
10848240|NCT00289198|OG001|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11294886|NCT02973516|OG000|Outcome|Cohort 1|Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294887|NCT02973516|OG001|Outcome|Cohort 2|Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294888|NCT02973516|EG000|Reported Event|Cohort 1|Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294889|NCT02973516|EG001|Reported Event|Cohort 2|Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
11294890|NCT02973802|BG000|Baseline|ATX-GD-59 Treatment|"An upward titration over five dose levels (25, 50, 100, 400 and 800 micrograms) followed by 5 doses of 800 micrograms of ATX-GD-59 administered two weeks apart by intradermal injection.~ATX-GD-59: Disease specific immune modulating treatment for Graves Disease"
11294891|NCT02973802|FG000|Participant Flow|ATX-GD-59 Treatment|"An upward titration over five dose levels (25, 50, 100, 400 and 800 micrograms) followed by 5 doses of 800 micrograms of ATX-GD-59 administered two weeks apart by intradermal injection.~ATX-GD-59: Disease specific immune modulating treatment for Graves Disease"
11294892|NCT02973802|OG000|Outcome|ATX-GD-59 Treatment|"An upward titration over five dose levels (25, 50, 100, 400 and 800 micrograms) followed by 5 doses of 800 micrograms of ATX-GD-59 administered two weeks apart by intradermal injection.~ATX-GD-59: Disease specific immune modulating treatment for Graves Disease"
11294893|NCT02973802|EG000|Reported Event|Treatment Emergent Adverse Events|Treatment emergent adverse events were any adverse events that started or worsened in severity on or after the first administration of study drug up to and including 28 days after the last administration of ATX-GD-59
11294894|NCT02973802|EG001|Reported Event|Non Treatment Emergent Adverse Events|Any non-treatment emergent adverse events.
11294895|NCT02974010|BG000|Baseline|Ketamine Followed by NRX-101|"NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone~NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294896|NCT02974010|BG001|Baseline|Ketamine Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294897|NCT02974010|BG002|Baseline|Saline Followed by NRX-101|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294898|NCT02974010|BG003|Baseline|Saline Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294899|NCT02974010|BG004|Baseline|Total|Total of all reporting groups
11294900|NCT02974010|FG000|Participant Flow|Ketamine Followed by NRX-101|"NRX-101 is a fixed dose combination of d-cycloserine and lurasidone~NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294901|NCT02974010|FG001|Participant Flow|Ketamine Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294902|NCT02974010|FG002|Participant Flow|Saline Followed by NRX-101|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294903|NCT02974010|FG003|Participant Flow|Saline Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294904|NCT02974010|OG000|Outcome|Ketamine Followed by NRX-101|"NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone~NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294905|NCT02974010|OG001|Outcome|Ketamine Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294906|NCT02974010|OG002|Outcome|Saline Followed by NRX-101|Saline (stage 1) followed by NRX-101 (stage 2)
11294907|NCT02974010|OG003|Outcome|Saline Followed by Lurasidone|Saline (stage 1) followed by lurasidone (stage 2)
11294908|NCT02974010|EG000|Reported Event|Ketamine Followed by NRX-101|"NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone~NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294909|NCT02974010|EG001|Reported Event|Ketamine Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294910|NCT02974010|EG002|Reported Event|Saline Followed by NRX-101|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294911|NCT02974010|EG003|Reported Event|Saline Followed by Lurasidone|"Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101~Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions~Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio~Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio"
11294912|NCT02974088|BG000|Baseline|Neem-based Lotion Plus Louse Comb|"Neem-based conditioning lotion plus head louse detection and removal comb~Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb"
11294913|NCT02974088|BG001|Baseline|Neem-based Lotion Plus Grooming Comb|"Neem-based conditioning lotion plus regular grooming comb~Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb"
11294914|NCT02974088|BG002|Baseline|Total|Total of all reporting groups
11216791|NCT02309138|OG001|Outcome|3 Hour 100 gm OGTT (CC Criteria)|"Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.~Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test"
11216792|NCT02309138|OG002|Outcome|IADPSG Without GDM|Participants diagnosed as having no GDM by IADPSG criteria
11216793|NCT02309138|OG003|Outcome|Carpenter Coustan Without GDM|Participants diagnosed as having no GDM with the Carpenter Coustan criteria
11216794|NCT02309138|EG000|Reported Event|3 Hour 100 gm OGTT (CC Criteria)|"Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.~Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test"
11216795|NCT02309138|EG001|Reported Event|2 hr 75 gm OGTT (IADPSG Criteria)|"Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.~Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test"
11216796|NCT02309294|BG000|Baseline|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11216797|NCT02309294|FG000|Participant Flow|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11216798|NCT02309294|OG000|Outcome|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11216799|NCT02309294|EG000|Reported Event|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11216800|NCT02309359|BG000|Baseline|ALX-0061 75 mg q4w + MTX|"ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216801|NCT02309359|BG001|Baseline|ALX-0061 150 mg q4w + MTX|"ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216802|NCT02309359|BG002|Baseline|ALX-0061 150 mg q2w + MTX|"ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216803|NCT02309359|BG003|Baseline|ALX-0061 225 mg q2w + MTX|"ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.~The last study drug administration was at the Week 22 visit.~ALX-0061~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216804|NCT02309359|BG004|Baseline|Placebo q2w + MTX|"Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216805|NCT02309359|BG005|Baseline|Total|Total of all reporting groups
11216806|NCT02309359|FG000|Participant Flow|ALX-0061 75 mg q4w + MTX|"ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + Methotrexate (MTX; at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216807|NCT02309359|FG001|Participant Flow|ALX-0061 150 mg q4w + MTX|"ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216808|NCT02309359|FG002|Participant Flow|ALX-0061 150 mg q2w + MTX|"ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216809|NCT02309359|FG003|Participant Flow|ALX-0061 225 mg q2w + MTX|"ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.~The last study drug administration was at the Week 22 visit.~ALX-0061~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216810|NCT02309359|FG004|Participant Flow|Placebo q2w + MTX|"Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216811|NCT02309359|OG000|Outcome|ALX-0061 75 mg q4w + MTX|"ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11294915|NCT02974088|FG000|Participant Flow|Neem-based Lotion Plus Louse Comb|"Neem-based conditioning lotion plus head louse detection and removal comb~Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb"
11294916|NCT02974088|FG001|Participant Flow|Neem-based Lotion Plus Grooming Comb|"Neem-based conditioning lotion plus regular grooming comb~Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb"
11294917|NCT02974088|OG000|Outcome|Neem-based Lotion Plus Louse Comb|"Neem-based conditioning lotion plus head louse detection and removal comb~Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb"
11294918|NCT02974088|OG001|Outcome|Neem-based Lotion Plus Grooming Comb|"Neem-based conditioning lotion plus regular grooming comb~Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb"
11294919|NCT02974088|EG000|Reported Event|Neem-based Lotion Plus Louse Comb|"Neem-based conditioning lotion plus head louse detection and removal comb~Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb"
11294920|NCT02974088|EG001|Reported Event|Neem-based Lotion Plus Grooming Comb|"Neem-based conditioning lotion plus regular grooming comb~Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb"
11294921|NCT02974114|BG000|Baseline|Paracetamol and Caffeine|All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets orally once with 200 mL of water.
11294922|NCT02974114|BG001|Baseline|Paracetamol|All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets orally once with 200 mL of water.
11294923|NCT02974114|BG002|Baseline|Placebo|All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets orally once with 200 mL of water.
11294924|NCT02974114|BG003|Baseline|Total|Total of all reporting groups
11294925|NCT02974114|FG000|Participant Flow|Paracetamol and Caffeine|All the participants in this arm received test product (containing 500 milligram [mg] of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.
11294926|NCT02974114|FG001|Participant Flow|Paracetamol|All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets orally once with 200 mL of water.
11294927|NCT02974114|FG002|Participant Flow|Placebo|All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets orally once with 200 mL of water.
11294928|NCT02974114|OG000|Outcome|Paracetamol and Caffeine|All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.
11294929|NCT02974114|OG001|Outcome|Paracetamol|All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.
11294930|NCT02974114|OG002|Outcome|Placebo|All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.
11294931|NCT02974114|OG001|Outcome|Paracetamol|All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.
11294932|NCT02974114|OG002|Outcome|Placebo|All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.
11294933|NCT02974114|EG000|Reported Event|Paracetamol and Caffeine|All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.
11294934|NCT02974114|EG001|Reported Event|Paracetamol|All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.
11294935|NCT02974114|EG002|Reported Event|Placebo|All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.
11294936|NCT02974140|BG000|Baseline|All Study Subjects|Cataract extraction surgery with either CRS or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
11294937|NCT02974140|FG000|Participant Flow|All Study Subjects|Cataract extraction surgery with either Cataract Refractive Suite (CRS) or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
11294938|NCT02974140|OG000|Outcome|Suite|Cataract surgery using Cataract Refractive Suite
11294939|NCT02974140|OG001|Outcome|Manual|Cataract surgery using standard manual technique
11294940|NCT02974140|EG000|Reported Event|Suite (Ocular)|Eyes for which the LenSx was activated and a laser cut was initiated
11294941|NCT02974140|EG001|Reported Event|Manual (Ocular)|Eyes for which the incision was initiated using standard manual techniques
11294942|NCT02974140|EG002|Reported Event|Nonocular|Subjects for which cataract surgery was conducted in one or both eyes
11294943|NCT02974153|BG000|Baseline|300 mg ALD403|Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294944|NCT02974153|BG001|Baseline|100 mg ALD403|Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294945|NCT02974153|BG002|Baseline|Placebo|Participants were randomized to receive a single placebo IV infusion on Days 0 and 84 (Week 12).
11294946|NCT02974153|BG003|Baseline|Total|Total of all reporting groups
11294947|NCT02974153|FG000|Participant Flow|300 mg ALD403|Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294948|NCT02974153|FG001|Participant Flow|100 mg ALD403|Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294949|NCT02974153|FG002|Participant Flow|Placebo|Participants were randomized to receive a single placebo IV infusion on Days 0 and 84 (Week 12).
11294950|NCT02974153|OG000|Outcome|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294951|NCT02974153|OG001|Outcome|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294952|NCT02974153|OG002|Outcome|Placebo|Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).
11294953|NCT02974153|EG000|Reported Event|300 mg ALD403|Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294954|NCT02974153|EG001|Reported Event|100 mg ALD403|Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).
11294955|NCT02974153|EG002|Reported Event|Placebo|Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).
11294956|NCT02974296|BG000|Baseline|New Target TMS|"new target transcranial magnetic stimulation guided by MRI~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294957|NCT02974296|BG001|Baseline|Standard TMS|"standard transcranial magnetic stimulation~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294958|NCT02974296|BG002|Baseline|Total|Total of all reporting groups
11294959|NCT02974296|FG000|Participant Flow|New Target TMS|"new target transcranial magnetic stimulation guided by MRI~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294960|NCT02974296|FG001|Participant Flow|Standard TMS|"standard transcranial magnetic stimulation~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294961|NCT02974296|OG000|Outcome|New Target TMS|"new target transcranial magnetic stimulation guided by MRI~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294962|NCT02974296|OG001|Outcome|Standard TMS|"standard transcranial magnetic stimulation~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294963|NCT02974296|EG000|Reported Event|New Target TMS|"new target transcranial magnetic stimulation guided by MRI~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294964|NCT02974296|EG001|Reported Event|Standard TMS|"standard transcranial magnetic stimulation~transcranial magnetic stimulation: non invasive brain stimulation approach"
11294965|NCT02974543|BG000|Baseline|Active 1st (Bimodal) Then Sham (Auditory Only)|During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
11294966|NCT02974543|BG001|Baseline|Sham 1st (Auditory Only) Then Active (Bimodal)|To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
11294967|NCT02974543|BG002|Baseline|Total|Total of all reporting groups
11294968|NCT02974543|FG000|Participant Flow|Sham 1st (Auditory Only) Then Active (Bimodal)|"To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~During active treatment, the device will deliver electric somatosensory and auditory stimulation.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
11294969|NCT02974543|FG001|Participant Flow|Active (Bimodal) Then Sham (Auditory Only)|"During active treatment, the device will deliver electric somatosensory and auditory stimulation.~To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
11294970|NCT02974543|OG000|Outcome|Active Before Sham|
11294971|NCT02974543|OG001|Outcome|Washout After Active|
11294972|NCT02974543|OG002|Outcome|Sham After Active|
11294973|NCT02974543|OG003|Outcome|Sham Before Active|
11294974|NCT02974543|OG004|Outcome|Washout After Sham|
11294975|NCT02974543|OG005|Outcome|Active After Sham|
11294976|NCT02974543|EG000|Reported Event|Active Before Sham|
11294977|NCT02974543|EG001|Reported Event|Washout After Active|
11294978|NCT02974543|EG002|Reported Event|Sham After Active|
11294979|NCT02974543|EG003|Reported Event|Sham Before Active|
11294980|NCT02974543|EG004|Reported Event|Washout After Sham|
11294981|NCT02974543|EG005|Reported Event|Active After Sham|
11294982|NCT02974634|BG000|Baseline|Ostomy Self Management Training|"Comparing OSMT group to UC group The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.~Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations"
11294983|NCT02974634|BG001|Baseline|Usual Care|"Comparing OSMT group to UC group~Subjects were provided with physician and Wound ostomy nurses contacts and written information about an ostomy care. These study subject were expected only to complete study surveys."
11294984|NCT02974634|BG002|Baseline|Total|Total of all reporting groups
11294985|NCT02974634|FG000|Participant Flow|Ostomy Self Management Training|"The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.~Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations"
11294986|NCT02974634|FG001|Participant Flow|Usual Care|Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.
11294987|NCT02974634|OG000|Outcome|Ostomy Self Management Training|"The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.~Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations"
11294988|NCT02974634|OG001|Outcome|Usual Care|Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.
11294989|NCT02974634|OG000|Outcome|Ostomy Self Management Training|The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
11294990|NCT02974634|EG000|Reported Event|Ostomy Self Management Training|The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
11294991|NCT02974634|EG001|Reported Event|Usual Care|Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.
11294992|NCT02974842|BG000|Baseline|Eligible Participants With Hysteroscopic Attempt|Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria.
11294993|NCT02974842|FG000|Participant Flow|MAKO 7 Group|Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation.
11294994|NCT02974842|OG000|Outcome|MAKO 7 Group|Fallopian tubes with adequate cytology samples obtained with MAKO 7 with available surgical histology results.
11294995|NCT02974842|EG000|Reported Event|MAKO 7 Group|Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria.
11294996|NCT02974855|BG000|Baseline|PF-06741086 300 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11294997|NCT02974855|BG001|Baseline|PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
11294998|NCT02974855|BG002|Baseline|PF-06741086 450 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11294999|NCT02974855|BG003|Baseline|PF-06741086 300 mg SC QW Inhibitor|Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295000|NCT02974855|BG004|Baseline|Total|Total of all reporting groups
11295001|NCT02974855|FG000|Participant Flow|PF-06741086 300 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295002|NCT02974855|FG001|Participant Flow|PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
11295003|NCT02974855|FG002|Participant Flow|PF-06741086 450 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295004|NCT02974855|FG003|Participant Flow|PF-06741086 300 mg SC QW Inhibitor|Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295005|NCT02974855|OG000|Outcome|PF-06741086 300 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295006|NCT02974855|OG001|Outcome|PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
11295007|NCT02974855|OG002|Outcome|PF-06741086 450 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295008|NCT02974855|OG003|Outcome|PF-06741086 300 mg SC QW Inhibitor|Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295009|NCT02974855|OG004|Outcome|Overall PF-06741086 300 mg SC|The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
11295010|NCT02974855|OG005|Outcome|Total|The total group combined participants from all PF-06741086 cohorts in this study.
11295011|NCT02974855|EG000|Reported Event|PF-06741086 300 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295012|NCT02974855|EG001|Reported Event|PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
11295013|NCT02974855|EG002|Reported Event|PF-06741086 450 mg SC QW Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295014|NCT02974855|EG003|Reported Event|PF-06741086 300 mg SC QW Inhibitor|Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
11295015|NCT02974855|EG004|Reported Event|Overall PF-06741086 300 mg SC|The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
11295016|NCT02974855|EG005|Reported Event|Total|The total group combined participants from all PF-06741086 cohorts in this study.
11295017|NCT02974868|BG000|Baseline|TP:Placebo|Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
11295018|NCT02974868|BG001|Baseline|TP:PF-06651600|Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.
11295019|NCT02974868|BG002|Baseline|TP:PF-06700841|Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
11295020|NCT02974868|BG003|Baseline|Total|Total of all reporting groups
11295021|NCT02974868|FG000|Participant Flow|Placebo for PF-06651600|Participants received placebo tablets QD matching for PF-06651600.
11295022|NCT02974868|FG001|Participant Flow|Placebo for PF-06700841|Participants received placebo tablets QD matching for PF-06700841.
11295023|NCT02974868|FG002|Participant Flow|PF-06651600|Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
11295024|NCT02974868|FG003|Participant Flow|PF-06700841|Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
11295025|NCT02974868|OG000|Outcome|PF-06651600|Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
11295026|NCT02974868|OG001|Outcome|PF-06700841|Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
11295027|NCT02974868|OG002|Outcome|Placebo|Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
11295028|NCT02974868|OG000|Outcome|PF-06651600-AT/AU|AT/AU Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
11295029|NCT02974868|OG001|Outcome|PF-06700841-AT/AU|AT/AU Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
11295030|NCT02974868|OG002|Outcome|Placebo-AT/AU|AT/AU Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
11295031|NCT02974868|OG000|Outcome|Active Non-responders on PF-06651600|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
11295032|NCT02974868|OG001|Outcome|Placebo Non-responders on PF-06651600|Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
11295033|NCT02974868|OG002|Outcome|Active Non-responders on PF-06700841|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
11295034|NCT02974868|OG003|Outcome|Placebo Non-responders on PF-06700841|Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
11295035|NCT02974868|OG004|Outcome|Non-Retreated PF-06651600 Responders in the Withdrawal Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
11295036|NCT02974868|OG005|Outcome|Retreated PF-06651600 Responders in the Withdrawal Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment
11295037|NCT02974868|OG006|Outcome|Non-Retreated PF-06700841 Responders in the Withdrawal Segment|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
11295038|NCT02974868|OG007|Outcome|Retreated PF-06700841 Responders in the Withdrawal Segment|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment
11295039|NCT02974868|OG008|Outcome|Retreated PF-06651600 Responders in the Retreatment Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
11295040|NCT02974868|OG009|Outcome|Retreated Responders on PF-06700841 in the Retreatment Segment|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
11295041|NCT02974868|OG000|Outcome|COE-PF-06651600|Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period
11295042|NCT02974868|OG001|Outcome|COE-PF-06700841|Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
11295043|NCT02974868|OG000|Outcome|PF-06651600 Responders|Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)
11295044|NCT02974868|OG001|Outcome|PF-06700841 Responders|Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)
11295045|NCT02974868|OG001|Outcome|Active Non-responders on PF-06700841|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
11295046|NCT02974868|OG002|Outcome|Placebo Non-responders on PF-06651600|Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
11295047|NCT02974868|OG004|Outcome|Retreated PF-06651600 Responders in the Retreatment Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
11295048|NCT02974868|OG005|Outcome|Retreated Responders on PF-06700841 in the Retreatment Segment|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
11295049|NCT02974868|EG000|Reported Event|Treatment Period-Placebo|Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
10842972|NCT00251004|OG000|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11295050|NCT02974868|EG001|Reported Event|Treatment Period-PF-06651600|Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.
11295051|NCT02974868|EG002|Reported Event|Treatment Period-PF-06700841|Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
11295052|NCT02974868|EG003|Reported Event|Single Blind Extension-Active Non-responders on PF-06651600|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
11295053|NCT02974868|EG004|Reported Event|Single Blind Extension-Placebo Non-responders on PF-06651600|Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
11295054|NCT02974868|EG005|Reported Event|Single Blind Extension-Active Non-responders on PF-06700841|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
11295055|NCT02974868|EG006|Reported Event|Single Blind Extension-Placebo Non-responders on PF-06700841|Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
11295056|NCT02974868|EG007|Reported Event|SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
11295057|NCT02974868|EG008|Reported Event|SBE-Retreated PF-06651600 Responders in Withdrawal Segment|"Participants initially treated with PF-06651600 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600.~This arm described AEs for retreated responders within withdrawal Segment."
11295058|NCT02974868|EG009|Reported Event|SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
11295059|NCT02974868|EG010|Reported Event|SBE-Retreated PF-06700841 Responders in the Withdrawal Segment|Participants initially treated with PF06700841 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841.This arm described AEs for retreated responders within Withdrawal Segment
11295060|NCT02974868|EG011|Reported Event|SBE-Retreated PF-06651600 Responders in Retreatment Segment|Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
11295061|NCT02974868|EG012|Reported Event|SBE-Retreated Responders on PF-06700841 in Retreatment Segment|Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
11295062|NCT02974868|EG013|Reported Event|Cross Over Extension-PF-06651600|Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period
11295063|NCT02974868|EG014|Reported Event|Cross Over Extension-PF-06700841|Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
11295064|NCT02975206|BG000|Baseline|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295065|NCT02975206|BG001|Baseline|Serlopitant 1 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295066|NCT02975206|BG002|Baseline|Placebo Oral Tablet|Subjects received a 3-tablet Placebo oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
11295067|NCT02975206|BG003|Baseline|Total|Total of all reporting groups
11295068|NCT02975206|FG000|Participant Flow|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295069|NCT02975206|FG001|Participant Flow|Serlopitant 1 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295070|NCT02975206|FG002|Participant Flow|Placebo Oral Tablet|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
11295071|NCT02975206|OG000|Outcome|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295072|NCT02975206|OG001|Outcome|Serlopitant 1 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks
10971139|NCT00914316|BG003|Baseline|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
10971140|NCT00914316|BG004|Baseline|Total|Total of all reporting groups
10971141|NCT00914316|FG000|Participant Flow|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
10971142|NCT00914316|FG001|Participant Flow|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
10971143|NCT00914316|FG002|Participant Flow|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
11295073|NCT02975206|OG002|Outcome|Placebo Oral Tablet|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks
11295074|NCT02975206|EG000|Reported Event|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295075|NCT02975206|EG001|Reported Event|Serlopitant 1 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks
11295076|NCT02975206|EG002|Reported Event|Placebo Oral Tablet|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks
10971144|NCT00914316|FG003|Participant Flow|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
11295077|NCT02975297|BG000|Baseline|Exenatide Plus NRT Plus Counseling|"Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling."
11295078|NCT02975297|BG001|Baseline|Placebo Plus NRT Plus Counseling|"Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling.~Placebo: Normal saline."
11295079|NCT02975297|BG002|Baseline|Total|Total of all reporting groups
11295080|NCT02975297|FG000|Participant Flow|Exenatide Plus NRT Plus Counseling|"Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling."
11295081|NCT02975297|FG001|Participant Flow|Placebo Plus NRT Plus Counseling|"Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling.~Placebo: Normal saline."
11295082|NCT02975297|OG000|Outcome|Exenatide Plus NRT Plus Counseling|"Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling."
11295083|NCT02975297|OG001|Outcome|Placebo Plus NRT Plus Counseling|"Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling.~Placebo: Normal saline."
11295084|NCT02975297|EG000|Reported Event|Exenatide Plus NRT Plus Counseling|"Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling."
10971145|NCT00914316|OG000|Outcome|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
10971146|NCT00914316|OG001|Outcome|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
11295085|NCT02975297|EG001|Reported Event|Placebo Plus NRT Plus Counseling|"Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling~NRT: Nicotine Patch (21mg) / 24 hours.~Counseling: Brief individual behavioral smoking cessation counseling.~Placebo: Normal saline."
11295086|NCT02975336|BG000|Baseline|DBPC Period: Placebo|Participants received placebo matched to M2951 orally for 52 weeks.
11295087|NCT02975336|BG001|Baseline|DBPC Period: M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
11295088|NCT02975336|BG002|Baseline|DBPC Period: M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 52 weeks.
11295089|NCT02975336|BG003|Baseline|DBPC Period: M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
11295090|NCT02975336|BG004|Baseline|Total|Total of all reporting groups
10971147|NCT00914316|OG002|Outcome|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
11295091|NCT02975336|FG000|Participant Flow|DBPC Period: Placebo|Participants received placebo matched to M2951 orally for 52 weeks.
11295092|NCT02975336|FG001|Participant Flow|DBPC Period: M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
11295093|NCT02975336|FG002|Participant Flow|DBPC Period: M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 52 weeks.
11295094|NCT02975336|FG003|Participant Flow|DBPC Period: M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
11295095|NCT02975336|FG004|Participant Flow|LTE: Placebo/ M2951 50 mg BID|Participants who received Placebo in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295096|NCT02975336|FG005|Participant Flow|LTE Period: M2951 25 mg QD/ M2951 50 mg BID|Participants who received 25 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295097|NCT02975336|FG006|Participant Flow|LTE Period: M2951 75 mg QD/ M2951 50 mg BID|Participants who received 75 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295098|NCT02975336|FG007|Participant Flow|LTE: M2951 50 mg BID/ M2951 50 mg BID|Participants who received 50 mg of M2951 orally BID in DBPC period continued to receive same dose of M2951 orally BID in LTE period for 104 weeks.
11295099|NCT02975336|OG000|Outcome|DBPC Period: Placebo|Participants received placebo matched to M2951 orally for 52 weeks.
11295100|NCT02975336|OG001|Outcome|DBPC Period: M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
11295101|NCT02975336|OG002|Outcome|DBPC Period: M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 52 weeks.
11295102|NCT02975336|OG003|Outcome|DBPC Period: M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
11295103|NCT02975336|EG000|Reported Event|DBPC Period: Placebo|Participants received placebo matched to M2951 orally for 52 weeks.
11295104|NCT02975336|EG001|Reported Event|DBPC Period: M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
11295105|NCT02975336|EG002|Reported Event|DBPC Period: M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 52 weeks.
11295106|NCT02975336|EG003|Reported Event|DBPC Period: M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
11295107|NCT02975336|EG004|Reported Event|LTE: Placebo/ M2951 50 mg BID|Participants who received Placebo in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295108|NCT02975336|EG005|Reported Event|LTE Period: M2951 25 mg QD/ M2951 50 mg BID|Participants who received 25 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295109|NCT02975336|EG006|Reported Event|LTE Period: M2951 75 mg QD/ M2951 50 mg BID|Participants who received 75 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
11295110|NCT02975336|EG007|Reported Event|LTE: M2951 50 mg BID/ M2951 50 mg BID|Participants who received 50 mg of M2951 orally BID in DBPC period continued to receive same dose of M2951 orally BID in LTE period for 104 weeks.
11295111|NCT02975349|BG000|Baseline|Placebo|Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1.
11295112|NCT02975349|BG001|Baseline|Evobrutinib 25 mg QD|Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295113|NCT02975349|BG002|Baseline|Evobrutinib 75 mg QD|Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295114|NCT02975349|BG003|Baseline|Evobrutinib 75 mg BID|Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period.
11295115|NCT02975349|BG004|Baseline|Tecfidera|Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period.
11295116|NCT02975349|BG005|Baseline|Total|Total of all reporting groups
11295117|NCT02975349|FG000|Participant Flow|Placebo|Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1.
11295118|NCT02975349|FG001|Participant Flow|Placebo Then Evobrutinib 25 mg QD|Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48.
11295119|NCT02975349|FG002|Participant Flow|Evobrutinib 25 mg QD|Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295120|NCT02975349|FG003|Participant Flow|Evobrutinib 75 mg QD|Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295121|NCT02975349|FG004|Participant Flow|Evobrutinib 75 mg BID|Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period.
11295122|NCT02975349|FG005|Participant Flow|Tecfidera|Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period.
11295123|NCT02975349|OG000|Outcome|Placebo|Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1.
11295124|NCT02975349|OG001|Outcome|Evobrutinib 25 mg QD|Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295125|NCT02975349|OG002|Outcome|Evobrutinib 75 mg QD|Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295126|NCT02975349|OG003|Outcome|Evobrutinib 75 mg BID|Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period.
11295127|NCT02975349|OG004|Outcome|Tecfidera|Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period.
11295128|NCT02975349|OG001|Outcome|Placebo Then Evobrutinib 25 mg QD|Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48.
11295129|NCT02975349|OG002|Outcome|Evobrutinib 25 mg QD|Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295130|NCT02975349|OG003|Outcome|Evobrutinib 75 mg QD|Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295131|NCT02975349|OG004|Outcome|Evobrutinib 75 mg BID|Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period.
11295132|NCT02975349|OG005|Outcome|Tecfidera|Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period.
11295133|NCT02975349|OG000|Outcome|Placebo Then Evobrutinib 25 mg QD|Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48.
11295134|NCT02975349|EG000|Reported Event|Placebo|Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1.
11295135|NCT02975349|EG001|Reported Event|Placebo Then Evobrutinib 25 mg QD|Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48.
11295136|NCT02975349|EG002|Reported Event|Evobrutinib 25 mg QD (Period 1 and Period 2)|Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295137|NCT02975349|EG003|Reported Event|Evobrutinib 75 mg QD (Period 1 and Period 2)|Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period.
11295138|NCT02975349|EG004|Reported Event|Evobrutinib 75 mg BID (Period 1 and Period 2)|Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period.
11295139|NCT02975349|EG005|Reported Event|Tecfidera (Period 1 and Period 2)|Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period.
11295140|NCT02975557|BG000|Baseline|Brimonidine 0.15%|"Brimonidine 0.15% eye drops 2 times a day for 12 weeks~Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks"
11295141|NCT02975557|BG001|Baseline|Brimonidine 0.075%|"Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.~Brimonidine 0.075%: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks."
11295142|NCT02975557|BG002|Baseline|Placebo|"Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.~Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks."
11295143|NCT02975557|BG003|Baseline|Total|Total of all reporting groups
11295144|NCT02975557|FG000|Participant Flow|Brimonidine 0.15%|"Brimonidine 0.15% eye drops 2 times a day for 12 weeks~Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks"
11295145|NCT02975557|FG001|Participant Flow|Brimonidine 0.075%|"Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.~Brimonidine 0.075%: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks."
11295146|NCT02975557|FG002|Participant Flow|Placebo|"Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.~Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks."
11295147|NCT02975557|OG000|Outcome|Brimonidine 0.15%|"Brimonidine 0.15% eye drops 2 times a day for 12 weeks~Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks"
11295148|NCT02975557|OG001|Outcome|Brimonidine 0.075%|"Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.~Brimonidine 0.075%: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks."
11295149|NCT02975557|OG002|Outcome|Placebo|"Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.~Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks."
11295150|NCT02975557|EG000|Reported Event|Brimonidine 0.15%|"Brimonidine 0.15% eye drops 2 times a day for 12 weeks~Brimonidine 0.15%: Brimonidine 0.15% eye drops 2 times a day for 12 weeks"
11295151|NCT02975557|EG001|Reported Event|Brimonidine 0.075%|"Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.~Brimonidine 0.075%: Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks."
11295152|NCT02975557|EG002|Reported Event|Placebo|"Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.~Placebo: Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks."
11332600|NCT03497845|OG007|Outcome|h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332601|NCT03497845|OG008|Outcome|i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11295153|NCT02975804|BG000|Baseline|Intervention|"The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.~Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game."
11295154|NCT02975804|BG001|Baseline|Control|Children in the control group will continue their usual therapy.
11295155|NCT02975804|BG002|Baseline|Total|Total of all reporting groups
11295156|NCT02975804|FG000|Participant Flow|Intervention|"The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.~Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game."
11295157|NCT02975804|FG001|Participant Flow|Control|Children in the control group will continue their usual therapy.
11295158|NCT02975804|OG000|Outcome|Intervention|"The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.~Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game."
11295159|NCT02975804|OG001|Outcome|Control|Children in the control group will continue their usual therapy.
11295160|NCT02975804|EG000|Reported Event|Intervention|"The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.~Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game."
11295161|NCT02975804|EG001|Reported Event|Control|Children in the control group will continue their usual therapy.
11295162|NCT02975973|BG000|Baseline|2.5mA|"Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295163|NCT02975973|BG001|Baseline|2.0mA|"Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295164|NCT02975973|BG002|Baseline|1.5mA|"Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295165|NCT02975973|BG003|Baseline|0mA (Active Placebo)|"This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295166|NCT02975973|BG004|Baseline|Total|Total of all reporting groups
11295167|NCT02975973|FG000|Participant Flow|2.5mA|"Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295168|NCT02975973|FG001|Participant Flow|2.0mA|"Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295169|NCT02975973|FG002|Participant Flow|1.5mA|"Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295170|NCT02975973|FG003|Participant Flow|0mA (Active Placebo)|"This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295171|NCT02975973|OG000|Outcome|2.5mA|"Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295172|NCT02975973|OG001|Outcome|2.0mA|"Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295173|NCT02975973|OG002|Outcome|1.5mA|"Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295174|NCT02975973|OG003|Outcome|0mA (Active Placebo)|"This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295175|NCT02975973|EG000|Reported Event|2.5mA|"Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295176|NCT02975973|EG001|Reported Event|2.0mA|"Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295177|NCT02975973|EG002|Reported Event|1.5mA|"Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295178|NCT02975973|EG003|Reported Event|0mA (Active Placebo)|"This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.~transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia."
11295179|NCT02976103|BG000|Baseline|Standard Care|"-Standard Care pain medicine/management will be given~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295180|NCT02976103|BG001|Baseline|JACKI® RECOVERY JACKET + Standard Care|"Patient will be encouraged to use the Jacki Recovery Jacket at home~Patient will be taught how to tuck the drainage tubes in the jacket pocket~Patient will be taught how to un-tuck the drainage tubes from jacket pocket~Standard care pain medicine/management will be given~Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295181|NCT02976103|BG002|Baseline|Total|Total of all reporting groups
11295182|NCT02976103|FG000|Participant Flow|Standard Care|"-Standard Care pain medicine/management will be given~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295183|NCT02976103|FG001|Participant Flow|JACKI® RECOVERY JACKET + Standard Care|"Patient will be encouraged to use the Jacki Recovery Jacket at home~Patient will be taught how to tuck the drainage tubes in the jacket pocket~Patient will be taught how to un-tuck the drainage tubes from jacket pocket~Standard care pain medicine/management will be given~Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295184|NCT02976103|OG000|Outcome|Standard Care|"-Standard Care pain medicine/management will be given~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295185|NCT02976103|OG001|Outcome|JACKI® RECOVERY JACKET + Standard Care|"Patient will be encouraged to use the Jacki Recovery Jacket at home~Patient will be taught how to tuck the drainage tubes in the jacket pocket~Patient will be taught how to un-tuck the drainage tubes from jacket pocket~Standard care pain medicine/management will be given~Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295186|NCT02976103|OG000|Outcome|JACKI® RECOVERY JACKET + Standard Care|"Patient will be encouraged to use the Jacki Recovery Jacket at home~Patient will be taught how to tuck the drainage tubes in the jacket pocket~Patient will be taught how to un-tuck the drainage tubes from jacket pocket~Standard care pain medicine/management will be given~Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295187|NCT02976103|EG000|Reported Event|Standard Care|"-Standard Care pain medicine/management will be given~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295188|NCT02976103|EG001|Reported Event|JACKI® RECOVERY JACKET + Standard Care|"Patient will be encouraged to use the Jacki Recovery Jacket at home~Patient will be taught how to tuck the drainage tubes in the jacket pocket~Patient will be taught how to un-tuck the drainage tubes from jacket pocket~Standard care pain medicine/management will be given~Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws~Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls"
11295189|NCT02976181|BG000|Baseline|Single Arm/Group Observational Registry|Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
11295190|NCT02976181|FG000|Participant Flow|Single Arm/Group Observational Registry|Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
11295191|NCT02976181|OG000|Outcome|Single Arm/Group Observational Registry|Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
11295192|NCT02976181|OG000|Outcome|Single Arm/Group Observational Registry|"Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy.~Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving indicated therapy pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving indicated therapy in Phase I are reported"
11295193|NCT02976181|EG000|Reported Event|Single Arm/Group Observational Registry|Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy Adverse events were not collected in this study. There were no deaths reported in the study.
11295194|NCT02976519|BG000|Baseline|Placebo Matching BI 443651|Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295195|NCT02976519|BG001|Baseline|BI 443651 100 Microgram (μg)|Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295196|NCT02976519|BG002|Baseline|BI 443651 400 μg|Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295197|NCT02976519|BG003|Baseline|BI 443651 1200 μg|Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295198|NCT02976519|BG004|Baseline|BI 443651 1800 μg|Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295199|NCT02976519|BG005|Baseline|BI 443651 600 μg/ Placebo Matching BI 443651|Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
11295200|NCT02976519|BG006|Baseline|Placebo Matching BI 443651/ BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
11295201|NCT02976519|BG007|Baseline|Total|Total of all reporting groups
11295202|NCT02976519|FG000|Participant Flow|Placebo Matching BI 443651|Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295203|NCT02976519|FG001|Participant Flow|BI 443651 100 Microgram (μg)|Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295204|NCT02976519|FG002|Participant Flow|BI 443651 400 μg|Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295205|NCT02976519|FG003|Participant Flow|BI 443651 1200 μg|Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295206|NCT02976519|FG004|Participant Flow|BI 443651 1800 μg|Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295207|NCT02976519|FG005|Participant Flow|BI 443651 600 μg/ Placebo Matching BI 443651|Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
10822230|NCT00075478|FG000|Participant Flow|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
11295208|NCT02976519|FG006|Participant Flow|Placebo Matching BI 443651/ BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
11295209|NCT02976519|OG000|Outcome|Placebo Matching BI 443651|Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295210|NCT02976519|OG001|Outcome|BI 443651 100 Microgram (μg)|Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295211|NCT02976519|OG002|Outcome|BI 443651 400 μg|Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295212|NCT02976519|OG003|Outcome|BI 443651 1200 μg|Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295213|NCT02976519|OG004|Outcome|BI 443651 1800 μg|Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295214|NCT02976519|OG005|Outcome|Placebo Matching BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
11295215|NCT02976519|OG006|Outcome|BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
11295216|NCT02976519|OG000|Outcome|BI 443651 100 Microgram (μg)|Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295217|NCT02976519|OG001|Outcome|BI 443651 400 μg|Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295218|NCT02976519|OG002|Outcome|BI 443651 1200 μg|Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295219|NCT02976519|OG003|Outcome|BI 443651 1800 μg|Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295220|NCT02976519|EG000|Reported Event|Placebo Matching BI 443651|Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295221|NCT02976519|EG001|Reported Event|BI 443651 100 Microgram (μg)|Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295222|NCT02976519|EG002|Reported Event|BI 443651 400 μg|Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295223|NCT02976519|EG003|Reported Event|BI 443651 1200 μg|Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295224|NCT02976519|EG004|Reported Event|BI 443651 1800 μg|Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
11295225|NCT02976519|EG005|Reported Event|Placebo Matching BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
11295226|NCT02976519|EG006|Reported Event|BI 443651 600 μg|Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
11295227|NCT02977507|BG000|Baseline|All Participants|"Participants were randomized to one of two treatment groups: Left side Lytera 2.0, Right side 4% hydroquinone or Left Side 4% hydroquinone, Right Side Lytera 2.0. Lytera 2.0 applied to the affected areas (dark patches) on one side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed."
11295228|NCT02977507|FG000|Participant Flow|Left Side Lytera 2.0, Right Side 4% Hydroquinone|Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11295229|NCT02977507|FG001|Participant Flow|Left Side 4% Hydroquinone, Right Side Lytera 2.0|4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11295230|NCT02977507|OG000|Outcome|Lytera 2.0|Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11295231|NCT02977507|OG001|Outcome|4% Hydroquinone Topical Cream|4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11295232|NCT02977507|OG002|Outcome|Normal Skin|Mexameter measurements were taken of the participant's normal skin.
11295233|NCT02977507|EG000|Reported Event|Left Side Lytera 2.0, Right Side 4% Hydroquinone|Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11295234|NCT02977507|EG001|Reported Event|Left Side 4% Hydroquinone, Right Side Lytera 2.0|4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
11216812|NCT02309359|OG001|Outcome|ALX-0061 150 mg q4w + MTX|"ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216813|NCT02309359|OG002|Outcome|ALX-0061 150 mg q2w + MTX|"ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216814|NCT02309359|OG003|Outcome|ALX-0061 225 mg q2w + MTX|"ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.~The last study drug administration was at the Week 22 visit.~ALX-0061~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216815|NCT02309359|OG004|Outcome|Placebo q2w + MTX|"Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216816|NCT02309359|OG005|Outcome|ALX-0061 Total|All participants who received ALX-0061
11216817|NCT02309359|EG000|Reported Event|ALX-0061 75 mg q4w + MTX|"ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216818|NCT02309359|EG001|Reported Event|ALX-0061 150 mg q4w + MTX|"ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216819|NCT02309359|EG002|Reported Event|ALX-0061 150 mg q2w + MTX|"ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~ALX-0061~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216820|NCT02309359|EG003|Reported Event|ALX-0061 225 mg q2w + MTX|"ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.~The last study drug administration was at the Week 22 visit.~ALX-0061~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
10971148|NCT00914316|OG003|Outcome|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
11216821|NCT02309359|EG004|Reported Event|Placebo q2w + MTX|"Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.~Placebo~Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor)."
11216822|NCT02309372|BG000|Baseline|Cognitive Behavioral Therapy (CBT)|"Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.~Beating the Blues: Computerized depression treatment intervention"
11216823|NCT02309372|BG001|Baseline|Usual Care|No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
11216824|NCT02309372|BG002|Baseline|Total|Total of all reporting groups
11216825|NCT02309372|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT)|"Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.~Beating the Blues: Computerized depression treatment intervention"
11216826|NCT02309372|FG001|Participant Flow|Usual Care|No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
11216827|NCT02309372|OG000|Outcome|Cognitive Behavioral Therapy (CBT)|"Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.~Beating the Blues: Computerized depression treatment intervention"
11216828|NCT02309372|OG001|Outcome|Usual Care|No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
11216829|NCT02309372|EG000|Reported Event|Cognitive Behavioral Therapy (CBT)|"Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.~Beating the Blues: Computerized depression treatment intervention"
11216830|NCT02309372|EG001|Reported Event|Usual Care|No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.
11216831|NCT02309411|BG000|Baseline|Rivaroxaban, Suspension, BID, Age: 2-6 Years|Subjects aged from 2 to 6 years were administered with age- and body weight-adjusted dose of rivaroxaban (BAY59-7939) oral suspension twice daily (BID) under fed conditions for 30 days.
11216832|NCT02309411|BG001|Baseline|Rivaroxaban Suspension, BID, Age: 6 Months-2 Years|Subjects aged from 6 months to 2 years were administered with age- and body weight-adjusted dose of rivaroxaban oral suspension BID under fed conditions for 30 days.
11216833|NCT02309411|BG002|Baseline|Anticoagulants, Comparator, Age: 2-6 Years|Subjects aged from 2 to 6 years were received comparator as per standard of care.
11216834|NCT02309411|BG003|Baseline|Total|Total of all reporting groups
11216835|NCT02309411|FG000|Participant Flow|Rivaroxaban, Suspension, BID, Age: 2-6 Years|Subjects aged from 2 to 6 years were administered with age- and body weight-adjusted dose of rivaroxaban (BAY59-7939) oral suspension twice daily (BID) under fed conditions for 30 days.
11216836|NCT02309411|FG001|Participant Flow|Rivaroxaban Suspension, BID, Age: 6 Months-2 Years|Subjects aged from 6 months to 2 years were administered with age- and body weight-adjusted dose of rivaroxaban oral suspension BID under fed conditions for 30 days.
11216837|NCT02309411|FG002|Participant Flow|Anticoagulants, Comparator, Age: 2-6 Years|Subjects aged from 2 to 6 years were received comparator as per standard of care.
11295235|NCT02977572|BG000|Baseline|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295236|NCT02977572|BG001|Baseline|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
11295237|NCT02977572|BG002|Baseline|Total|Total of all reporting groups
11295238|NCT02977572|FG000|Participant Flow|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
11295239|NCT02977572|FG001|Participant Flow|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295240|NCT02977572|OG000|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
10848241|NCT00289198|OG001|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11295241|NCT02977572|OG001|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295242|NCT02977572|OG000|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
11295243|NCT02977572|OG001|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295244|NCT02977572|OG000|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295245|NCT02977572|OG001|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
11295246|NCT02977572|EG000|Reported Event|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Non-Invasive Ventilation: In arm description"
11295247|NCT02977572|EG001|Reported Event|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.~Continuous Positive Airway Pressure: In arm description"
11295248|NCT02978157|BG000|Baseline|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d."
11295249|NCT02978157|BG001|Baseline|Esomeprazole+Bismuth+Tetra+Levo|"esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d."
11295250|NCT02978157|BG002|Baseline|Total|Total of all reporting groups
11295251|NCT02978157|FG000|Participant Flow|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d."
11295252|NCT02978157|FG001|Participant Flow|Esomeprazole+Bismuth+Tetra+Levo|"esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d."
11295253|NCT02978157|OG000|Outcome|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d."
11295254|NCT02978157|OG001|Outcome|Esomeprazole+Bismuth+Tetra+Levo|"esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d."
11295255|NCT02978157|EG000|Reported Event|Esomeprazole+Amox+Levo|"esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d."
11295256|NCT02978157|EG001|Reported Event|Esomeprazole+Bismuth+Tetra+Levo|"esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.~esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d."
11295257|NCT02978183|BG000|Baseline|Group 1|"1X ST266 dosed 4 times a day for 8 days~ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
11295258|NCT02978183|BG001|Baseline|Group 2|"Placebo dosed 4 times a day for 8 days~Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
11295259|NCT02978183|BG002|Baseline|Total|Total of all reporting groups
11295260|NCT02978183|FG000|Participant Flow|Group 1|"1X ST266 dosed 4 times a day for 8 days~ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
11295261|NCT02978183|FG001|Participant Flow|Group 2|"Placebo dosed 4 times a day for 8 days~Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
10971149|NCT00914316|EG000|Reported Event|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
10971150|NCT00914316|EG001|Reported Event|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
10971151|NCT00914316|EG002|Reported Event|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
10971152|NCT00914316|EG003|Reported Event|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
11295262|NCT02978183|OG000|Outcome|Group 1|"1X ST266 dosed 4 times a day for 8 days~ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
10971153|NCT00914459|BG000|Baseline|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971154|NCT00914459|BG001|Baseline|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971155|NCT00914459|BG002|Baseline|Total|Total of all reporting groups
10971156|NCT00914459|FG000|Participant Flow|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 international units per kilogram [IU/kg] up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the Summary of Product Characteristics (SmPC).
10971157|NCT00914459|FG001|Participant Flow|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
11295263|NCT02978183|OG001|Outcome|Group 2|"Placebo dosed 4 times a day for 8 days~Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
11295264|NCT02978183|EG000|Reported Event|Group 1|"1X ST266 dosed 4 times a day for 8 days~ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
10971158|NCT00914459|OG000|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971159|NCT00914459|OG001|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971160|NCT00914459|OG000|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971161|NCT00914459|OG000|Outcome|ReFacto AF: All Participants|All participants (aged less than or equal to [<=] 12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971162|NCT00914459|OG000|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971163|NCT00914459|EG000|Reported Event|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
10971164|NCT00914485|BG000|Baseline|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
10971165|NCT00914485|FG000|Participant Flow|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
11295265|NCT02978183|EG001|Reported Event|Group 2|"Placebo dosed 4 times a day for 8 days~Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days."
11295266|NCT02978339|BG000|Baseline|Curcumin|"Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.~Curcumin: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin."
11295267|NCT02978339|FG000|Participant Flow|Curcumin|"Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.~Curcumin: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin."
11295268|NCT02978339|OG000|Outcome|Curcumin|"Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.~Curcumin: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin."
11295269|NCT02978339|EG000|Reported Event|Curcumin|"Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.~Curcumin: Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin."
11295270|NCT02978417|BG000|Baseline|Vivitrol|"All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).~Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12"
11295271|NCT02978417|BG001|Baseline|Oral Naltrexone|"Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.~Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing."
11295272|NCT02978417|BG002|Baseline|Total|Total of all reporting groups
11295273|NCT02978417|FG000|Participant Flow|Vivitrol|"All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).~Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12"
11295274|NCT02978417|FG001|Participant Flow|Oral Naltrexone|"Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.~Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing."
11295275|NCT02978417|OG000|Outcome|Vivitrol|"All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).~Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12"
11332602|NCT03497845|OG009|Outcome|j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332603|NCT03497845|OG010|Outcome|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11295276|NCT02978417|OG001|Outcome|Oral Naltrexone|"Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.~Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing."
11295277|NCT02978417|EG000|Reported Event|Vivitrol|"All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).~Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12"
11295278|NCT02978417|EG001|Reported Event|Oral Naltrexone|"Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.~Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing."
11295279|NCT02978508|BG000|Baseline|Permethrin Cream, 5%|"Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.~Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295280|NCT02978508|BG001|Baseline|Elimite|"Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (Prestium), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.~Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295281|NCT02978508|BG002|Baseline|Total|Total of all reporting groups
11295282|NCT02978508|FG000|Participant Flow|Permethrin Cream, 5%|"Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.~Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295283|NCT02978508|FG001|Participant Flow|Elimite|"Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (Prestium), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.~Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295284|NCT02978508|OG000|Outcome|Permethrin Cream, 5%|"Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.~Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295285|NCT02978508|OG001|Outcome|Elimite|"Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (Prestium), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.~Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295286|NCT02978508|EG000|Reported Event|Permethrin Cream, 5%|"Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.~Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11332604|NCT03497845|OG011|Outcome|l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10971166|NCT00914485|OG000|Outcome|Arm 1|"Provider clinical communication training intervention~Provider Communication Skills Training: Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
11332605|NCT03497845|OG010|Outcome|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11295287|NCT02978508|EG001|Reported Event|Elimite|"Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (Prestium), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.~Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary."
11295288|NCT02979054|BG000|Baseline|T4020|"1 drop every other day during 5 days~T4020"
11295289|NCT02979054|BG001|Baseline|Saline Solution|"1 drop every other day during 5 days~Placebo"
11295290|NCT02979054|BG002|Baseline|Total|Total of all reporting groups
11295291|NCT02979054|FG000|Participant Flow|T4020|"1 drop every other day during 5 days~T4020"
11295292|NCT02979054|FG001|Participant Flow|Saline Solution|"1 drop every other day during 5 days~Placebo"
11295293|NCT02979054|OG000|Outcome|T4020|"1 drop every other day during 5 days~T4020"
11295294|NCT02979054|OG001|Outcome|Saline Solution|"1 drop every other day during 5 days~Placebo"
11295295|NCT02979054|EG000|Reported Event|T4020|"1 drop every other day during 5 days~T4020"
11295296|NCT02979054|EG001|Reported Event|Saline Solution|"1 drop every other day during 5 days~Placebo"
11295297|NCT02979197|BG000|Baseline|Amlodipine+Celecoxib|OE 10 mg amlodipine besylate tablet + OE 200 mg celecoxib capsule qd for 14 days
10971167|NCT00914485|EG000|Reported Event|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
10971168|NCT00914589|BG000|Baseline|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
11295298|NCT02979197|BG001|Baseline|Amlodipine+Placebo|OE 10 mg amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295299|NCT02979197|BG002|Baseline|Placebo+Placebo|Matched placebo for OE amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295300|NCT02979197|BG003|Baseline|Total|Total of all reporting groups
11295301|NCT02979197|FG000|Participant Flow|Amlodipine+Celecoxib|OE 10 mg amlodipine besylate tablet + OE 200 mg celecoxib capsule qd for 14 days
11295302|NCT02979197|FG001|Participant Flow|Amlodipine+Placebo|OE 10 mg amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295303|NCT02979197|FG002|Participant Flow|Placebo+Placebo|Matched placebo for OE amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295304|NCT02979197|OG000|Outcome|Amlodipine+Celecoxib|OE 10 mg amlodipine besylate tablet + OE 200 mg celecoxib capsule qd for 14 days
11295305|NCT02979197|OG001|Outcome|Amlodipine+Placebo|OE 10 mg amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295306|NCT02979197|OG002|Outcome|Placebo+Placebo|Matched placebo for OE amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295307|NCT02979197|EG000|Reported Event|Amlodipine+Celecoxib|OE 10 mg amlodipine besylate tablet + OE 200 mg celecoxib capsule qd for 14 days
11295308|NCT02979197|EG001|Reported Event|Amlodipine+Placebo|OE 10 mg amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295309|NCT02979197|EG002|Reported Event|Placebo+Placebo|Matched placebo for OE amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days
11295310|NCT02979249|BG000|Baseline|Oral Iron|standard dose of oral iron pills for one year
11295311|NCT02979249|FG000|Participant Flow|Oral Iron|standard dose of oral iron pills for one year
11295312|NCT02979249|OG000|Outcome|Oral Iron|standard dose of oral iron pills for one year
11295313|NCT02979249|EG000|Reported Event|Oral Iron|standard dose of oral iron pills for one year
11295314|NCT02979262|BG000|Baseline|Fathers for Change|"Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.~Fathers for Change"
11295315|NCT02979262|BG001|Baseline|Parent Education (PE)|"PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.~Parent Education"
11295316|NCT02979262|BG002|Baseline|Total|Total of all reporting groups
11295317|NCT02979262|FG000|Participant Flow|Fathers for Change|"Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.~Fathers for Change"
11295318|NCT02979262|FG001|Participant Flow|Parent Education (PE)|"PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.~Parent Education"
11295319|NCT02979262|OG000|Outcome|Fathers for Change|"Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.~Fathers for Change"
11295320|NCT02979262|OG001|Outcome|Parent Education (PE)|"PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.~Parent Education"
11295321|NCT02979262|EG000|Reported Event|Fathers for Change|"Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.~Fathers for Change"
11295322|NCT02979262|EG001|Reported Event|Parent Education (PE)|"PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.~Parent Education"
11295323|NCT02979301|BG000|Baseline|Tamoxifen 5 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295324|NCT02979301|BG001|Baseline|Tamoxifen 10 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295325|NCT02979301|BG002|Baseline|Total|Total of all reporting groups
11295326|NCT02979301|FG000|Participant Flow|Tamoxifen 5 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295327|NCT02979301|FG001|Participant Flow|Tamoxifen 10 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295328|NCT02979301|OG000|Outcome|Tamoxifen 5 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295329|NCT02979301|OG001|Outcome|Tamoxifen 10 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
10848242|NCT00289198|EG000|Reported Event|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
10971169|NCT00914589|BG001|Baseline|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
11295330|NCT02979301|EG000|Reported Event|Tamoxifen 5 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295331|NCT02979301|EG001|Reported Event|Tamoxifen 10 mg/Day|"Women with a history of high background uptake on MBI were enrolled.~A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam."
11295332|NCT02979431|BG000|Baseline|Placebo|Inhalation of Placebo once daily for 3 consecutive days
11295333|NCT02979431|BG001|Baseline|ALX-0171 3.0 mg/kg|Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days
11295334|NCT02979431|BG002|Baseline|ALX-0171 6.0 mg/kg|Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days
11295335|NCT02979431|BG003|Baseline|ALX-0171 9.0mg/kg|Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days
11295336|NCT02979431|BG004|Baseline|Total|Total of all reporting groups
11295337|NCT02979431|FG000|Participant Flow|Placebo|Inhalation of Placebo once daily for 3 consecutive days
11295338|NCT02979431|FG001|Participant Flow|ALX-0171 3.0 mg/kg|Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days
11295339|NCT02979431|FG002|Participant Flow|ALX-0171 6.0 mg/kg|Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days
11295340|NCT02979431|FG003|Participant Flow|ALX-0171 9.0mg/kg|Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days
11295341|NCT02979431|OG000|Outcome|Placebo|Inhalation of Placebo once daily for 3 consecutive days
11295342|NCT02979431|OG001|Outcome|ALX-0171 3.0 mg/kg|Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days
11295343|NCT02979431|OG002|Outcome|ALX-0171 6.0 mg/kg|Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days
11295344|NCT02979431|OG003|Outcome|ALX-0171 9.0mg/kg|Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days
11295345|NCT02979431|EG000|Reported Event|Placebo|Inhalation of Placebo once daily for 3 consecutive days
11295346|NCT02979431|EG001|Reported Event|ALX-0171 3.0 mg/kg|Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days
11295347|NCT02979431|EG002|Reported Event|ALX-0171 6.0 mg/kg|Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days
10971170|NCT00914589|BG002|Baseline|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
11295348|NCT02979431|EG003|Reported Event|ALX-0171 9.0mg/kg|Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days
11295349|NCT02979444|BG000|Baseline|Mothers and Babies Groups Home-Visitor|"Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295350|NCT02979444|BG001|Baseline|Mothers and Babies Groups Clinician|"Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295351|NCT02979444|BG002|Baseline|Control|Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
11295352|NCT02979444|BG003|Baseline|Total|Total of all reporting groups
11295353|NCT02979444|FG000|Participant Flow|Mothers and Babies Groups Home-Visitor|"Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components: Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295354|NCT02979444|FG001|Participant Flow|Mothers and Babies Groups Clinician|"Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components: Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295355|NCT02979444|FG002|Participant Flow|Control|Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum. These women will receive usual home visiting services.
11332606|NCT03497845|OG004|Outcome|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11295356|NCT02979444|OG000|Outcome|Mothers and Babies Groups Home-Visitor|"Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295357|NCT02979444|OG001|Outcome|Mothers and Babies Groups Clinician|"Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295358|NCT02979444|OG002|Outcome|Control|Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
11295359|NCT02979444|EG000|Reported Event|Mothers and Babies Groups Home-Visitor|"Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295360|NCT02979444|EG001|Reported Event|Mothers and Babies Groups Clinician|"Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.~Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
11295361|NCT02979444|EG002|Reported Event|Control|Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
11295362|NCT02979613|BG000|Baseline|TAF 25 mg|Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295363|NCT02979613|BG001|Baseline|TDF 300 mg|Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295364|NCT02979613|BG002|Baseline|Total|Total of all reporting groups
11295365|NCT02979613|FG000|Participant Flow|TAF 25 mg|Participants who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily received tenofovir alafenamide (TAF) 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the double-blind (DB) phase. Participants who completed DB treatment and were willing to enter in the open-label extension (OLE) phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
10971171|NCT00914589|BG003|Baseline|Total|Total of all reporting groups
11295366|NCT02979613|FG001|Participant Flow|TDF 300 mg|Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295367|NCT02979613|OG000|Outcome|TAF 25 mg|Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295368|NCT02979613|OG001|Outcome|TDF 300 mg|Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295369|NCT02979613|EG000|Reported Event|TAF 25 mg|Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase.
11295370|NCT02979613|EG001|Reported Event|TDF 300 mg|Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase.
11295371|NCT02979613|EG002|Reported Event|OLE TAF 25 mg From TAF 25 mg|Adverse events reported in this group occurred during the OLE phase. Participants who completed TAF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295372|NCT02979613|EG003|Reported Event|OLE TAF 25 mg From TDF 300 mg|Adverse events reported in this group occurred during the OLE phase. Participants who completed TDF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
11295373|NCT02979626|BG000|Baseline|Moderate-to-severe Influenza|"Children 6 weeks to 8 years of age with influenza-like illness and one of the following:~Fever >39~Lower respiratory tract infection~Acute otitis media~Serious extra-pulmonary manifestations (myositis, encephalitis)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295374|NCT02979626|BG001|Baseline|Mild Influenza|"Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295375|NCT02979626|BG002|Baseline|Total|Total of all reporting groups
11295376|NCT02979626|FG000|Participant Flow|Moderate-to-severe Influenza|"Children 6 weeks to 8 years of age with influenza-like illness and one of the following:~Fever >39~Lower respiratory tract infection~Acute otitis media~Serious extra-pulmonary manifestations (myositis, encephalitis)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295377|NCT02979626|FG001|Participant Flow|Mild Influenza|"Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295378|NCT02979626|OG000|Outcome|Moderate-to-severe Influenza|"Children 6 weeks to 8 years of age with influenza-like illness and one of the following:~Fever >39~Lower respiratory tract infection~Acute otitis media~Serious extra-pulmonary manifestations (myositis, encephalitis)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295379|NCT02979626|OG001|Outcome|Mild Influenza|"Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295380|NCT02979626|EG000|Reported Event|Moderate-to-severe Influenza|"Children 6 weeks to 8 years of age with influenza-like illness and one of the following:~Fever >39~Lower respiratory tract infection~Acute otitis media~Serious extra-pulmonary manifestations (myositis, encephalitis)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295381|NCT02979626|EG001|Reported Event|Mild Influenza|"Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)~Respiratory nasal swab: Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required."
11295382|NCT02979639|BG000|Baseline|GSK1437173A Group|Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
11295383|NCT02979639|FG000|Participant Flow|GSK1437173A Group|Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
10971172|NCT00914589|FG000|Participant Flow|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
11295384|NCT02979639|OG000|Outcome|GSK1437173A Group|Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
11295385|NCT02979639|EG000|Reported Event|GSK1437173A Group|Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
11295386|NCT02979899|BG000|Baseline|TRC105 + Votrient|"Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily~TRC105: TRC105 antibody~Votrient: pazopanib"
11295387|NCT02979899|BG001|Baseline|Votrient|"Standard dose votrient by mouth, once daily~Votrient: pazopanib"
11295388|NCT02979899|BG002|Baseline|Total|Total of all reporting groups
11295389|NCT02979899|FG000|Participant Flow|TRC105 + Votrient|"Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily~TRC105: TRC105 antibody~Votrient: pazopanib"
11295390|NCT02979899|FG001|Participant Flow|Votrient|"Standard dose votrient by mouth, once daily~Votrient: pazopanib"
11295391|NCT02979899|OG000|Outcome|TRC105 + Votrient|"Weekly TRC105 i.v. in combination with standard dose votrient by mouth, once daily~TRC105: TRC105 antibody~Votrient: pazopanib"
11295392|NCT02979899|OG001|Outcome|Votrient|"Standard dose votrient by mouth, once daily~Votrient: pazopanib"
11295393|NCT02979899|EG000|Reported Event|TRC105 + Votrient|All patients that received at least one dose of TRC105 in combination with pazopanib
11295394|NCT02979899|EG001|Reported Event|Votrient|All patients that received at least one dose of pazopanib alone.
11295395|NCT02979925|BG000|Baseline|Active Transcutaneous Magnetic Stimulation|"Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.~Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury."
11295396|NCT02979925|BG001|Baseline|Sham Transcutaneous Magnetic Stimulation|"Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11295397|NCT02979925|BG002|Baseline|Total|Total of all reporting groups
11295398|NCT02979925|FG000|Participant Flow|Active Transcutaneous Magnetic Stimulation|"Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.~Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury."
11295399|NCT02979925|FG001|Participant Flow|Sham Transcutaneous Magnetic Stimulation|"Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11295400|NCT02979925|OG000|Outcome|Active Transcutaneous Magnetic Stimulation|"Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.~Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury."
11295401|NCT02979925|OG001|Outcome|Sham Transcutaneous Magnetic Stimulation|"Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11295402|NCT02979925|EG000|Reported Event|Active Transcutaneous Magnetic Stimulation|"Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury.~Active Transcutaneous Magnetic Stimulation: Active transcutaneous magnetic stimulation (tMS) at the target site of nerve damage/injury."
11295403|NCT02979925|EG001|Reported Event|Sham Transcutaneous Magnetic Stimulation|"Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.~Sham Transcutaneous Magnetic Stimulation: Sham tMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil."
11295404|NCT02980042|BG000|Baseline|Switching Group|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295405|NCT02980042|BG001|Baseline|Comparator Group|"Standard of care rituximab doses are 1000 mg infusion given as first dose followed by 500mg (or 1000 mg if evidence of early B cell recovery) infusion every 6 months thereafter. Rituximab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and rituximab should be infused through a dedicated line~Rituximab: A chimeric monoclonal antibody against CD20."
11295406|NCT02980042|BG002|Baseline|Total|Total of all reporting groups
11295407|NCT02980042|FG000|Participant Flow|Switching Group|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295408|NCT02980042|FG001|Participant Flow|Comparator Group|"Standard of care rituximab doses are 1000 mg infusion given as first dose followed by 500mg (or 1000 mg if evidence of early B cell recovery) infusion every 6 months thereafter. Rituximab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and rituximab should be infused through a dedicated line~Rituximab: A chimeric monoclonal antibody against CD20."
11295409|NCT02980042|OG000|Outcome|Switching Group|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295410|NCT02980042|OG001|Outcome|Comparator Group|"Standard of care rituximab doses are 1000 mg infusion given as first dose followed by 500mg (or 1000 mg if evidence of early B cell recovery) infusion every 6 months thereafter. Rituximab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and rituximab should be infused through a dedicated line~Rituximab: A chimeric monoclonal antibody against CD20."
11295411|NCT02980042|OG000|Outcome|Switching Group|600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.
11295412|NCT02980042|OG000|Outcome|Switching Group - Day 1 Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295413|NCT02980042|OG001|Outcome|Switching Group - Day 15 Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295414|NCT02980042|OG002|Outcome|Switching Group - Week 24 Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295415|NCT02980042|OG001|Outcome|Switching Group - Week 24 Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295416|NCT02980042|OG000|Outcome|Switching Group - Day 1|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295417|NCT02980042|OG001|Outcome|Switching Group - Week 24|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11332607|NCT03497845|OG000|Outcome|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332608|NCT03497845|OG001|Outcome|f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11295418|NCT02980042|OG002|Outcome|Switching Group - 1 Year|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295419|NCT02980042|OG000|Outcome|Switching Group - Day 1 - Pre Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells~Pre-Infusion"
11295420|NCT02980042|OG001|Outcome|Switching Group - Day 1 - Post Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells~Post-Infusion"
11295421|NCT02980042|OG000|Outcome|Switching Group - Day 15 - Pre Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells~Pre-Infusion"
11295422|NCT02980042|OG001|Outcome|Switching Group - Day 15 - Post Infusion|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells~Post-Infusion"
11295423|NCT02980042|EG000|Reported Event|Switching Group|"600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.~Ocrelizumab: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells"
11295424|NCT02980042|EG001|Reported Event|Comparator Group|"Standard of care rituximab doses are 1000 mg infusion given as first dose followed by 500mg (or 1000 mg if evidence of early B cell recovery) infusion every 6 months thereafter. Rituximab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and rituximab should be infused through a dedicated line~Rituximab: A chimeric monoclonal antibody against CD20."
11295425|NCT02980107|BG000|Baseline|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11295426|NCT02980107|BG001|Baseline|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11295427|NCT02980107|BG002|Baseline|Total|Total of all reporting groups
11295428|NCT02980107|FG000|Participant Flow|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
10971173|NCT00914589|FG001|Participant Flow|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
11295429|NCT02980107|FG001|Participant Flow|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11295430|NCT02980107|OG000|Outcome|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11295431|NCT02980107|OG001|Outcome|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11295432|NCT02980107|EG000|Reported Event|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~PLS: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11295433|NCT02980107|EG001|Reported Event|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11295434|NCT02980133|BG000|Baseline|Placebo MDPI|Participants received matching placebo via MDPI for 12 weeks.
11295435|NCT02980133|BG001|Baseline|Fp MDPI 25 mcg BID|Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
11295436|NCT02980133|BG002|Baseline|Fp MDPI 50 mcg BID|Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
11295437|NCT02980133|BG003|Baseline|FS MDPI 50/12.5 mcg BID|Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
11295438|NCT02980133|BG004|Baseline|Total|Total of all reporting groups
11295439|NCT02980133|FG000|Participant Flow|Placebo MDPI|Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.
11295440|NCT02980133|FG001|Participant Flow|Fp MDPI 25 mcg BID|Participants received 1 inhalation of 25 micrograms (mcg) fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.
11295441|NCT02980133|FG002|Participant Flow|Fp MDPI 50 mcg BID|Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
11295442|NCT02980133|FG003|Participant Flow|FS MDPI 50/12.5 mcg BID|Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
11295443|NCT02980133|OG000|Outcome|Fp MDPI 25 mcg BID|Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
11295444|NCT02980133|OG001|Outcome|Fp MDPI 50 mcg BID|Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
11295445|NCT02980133|OG002|Outcome|FS MDPI 50/12.5 mcg BID|Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
11295446|NCT02980133|OG000|Outcome|Placebo MDPI|Participants received matching placebo via MDPI for 12 weeks.
11295447|NCT02980133|OG001|Outcome|Fp MDPI 25 mcg BID|Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
11295448|NCT02980133|OG002|Outcome|Fp MDPI 50 mcg BID|Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
11295449|NCT02980133|OG003|Outcome|FS MDPI 50/12.5 mcg BID|Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
11295450|NCT02980133|EG000|Reported Event|Placebo MDPI|Participants received matching placebo via MDPI for 12 weeks.
11295451|NCT02980133|EG001|Reported Event|Fp MDPI 25 mcg BID|Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
11295452|NCT02980133|EG002|Reported Event|Fp MDPI 50 mcg BID|Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
11295453|NCT02980133|EG003|Reported Event|FS MDPI 50/12.5 mcg BID|Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
11295454|NCT02980211|BG000|Baseline|Tooth Extraction and Graft Dehisced Socket|"Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.~Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane"
11295455|NCT02980211|FG000|Participant Flow|Tooth Extraction and Graft Dehisced Socket|"Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.~Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane"
11295456|NCT02980211|OG000|Outcome|Tooth Extraction and Graft Dehisced Socket|"Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.~Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane"
11295457|NCT02980211|EG000|Reported Event|Tooth Extraction and Graft Dehisced Socket|"Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.~Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane"
11295458|NCT02980224|BG000|Baseline|OmegaD|"OmegaD Softgels~OmegaD: OmegaD Softgels"
11295459|NCT02980224|BG001|Baseline|Placebo|"Placebo Softgels~Placebo: Placebo Softgels"
11295460|NCT02980224|BG002|Baseline|Total|Total of all reporting groups
11295461|NCT02980224|FG000|Participant Flow|OmegaD|"OmegaD Softgels~OmegaD: OmegaD Softgels"
11295462|NCT02980224|FG001|Participant Flow|Placebo|"Placebo Softgels~Placebo: Placebo Softgels"
10848243|NCT00289198|EG001|Reported Event|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
11295463|NCT02980224|OG000|Outcome|OmegaD|"OmegaD Softgels~OmegaD: OmegaD Softgels"
11295464|NCT02980224|OG001|Outcome|Placebo|"Placebo Softgels~Placebo: Placebo Softgels"
11295465|NCT02980224|EG000|Reported Event|OmegaD|"OmegaD Softgels~OmegaD: OmegaD Softgels"
11295466|NCT02980224|EG001|Reported Event|Placebo|"Placebo Softgels~Placebo: Placebo Softgels"
11295467|NCT02980523|BG000|Baseline|PRO-157 BID|One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%)
11295468|NCT02980523|BG001|Baseline|PRO-157 TID|One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)
11295469|NCT02980523|BG002|Baseline|PRO-157 QID|One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)
11295470|NCT02980523|BG003|Baseline|Moxifloxacine|One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®).
11295471|NCT02980523|BG004|Baseline|Gatifloxacine|One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®).
11295472|NCT02980523|BG005|Baseline|Total|Total of all reporting groups
11295473|NCT02980523|FG000|Participant Flow|PRO-157 BID (2 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days~instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295474|NCT02980523|FG001|Participant Flow|PRO-157 TID (3 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295475|NCT02980523|FG002|Participant Flow|PRO-157 QID (4 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295476|NCT02980523|FG003|Participant Flow|Moxifloxacin (Vigamox®)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)~Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295477|NCT02980523|FG004|Participant Flow|Gatifloxacin (Zymar®)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)~Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295478|NCT02980523|OG000|Outcome|PRO-157 BID (2 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days~instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295479|NCT02980523|OG001|Outcome|PRO-157 TID (3 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295480|NCT02980523|OG002|Outcome|PRO-157 QID (4 Times Per Day)|"60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295481|NCT02980523|OG003|Outcome|Moxifloxacin (Vigamox®)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)~Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295482|NCT02980523|OG004|Outcome|Gatifloxacin (Zymar®)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)~Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295483|NCT02980523|OG000|Outcome|PRO-157 BID (2 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days~instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295484|NCT02980523|OG001|Outcome|PRO-157 TID (3 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295485|NCT02980523|OG002|Outcome|PRO-157 QID (4 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295486|NCT02980523|EG000|Reported Event|PRO-157 BID (2 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days~instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295487|NCT02980523|EG001|Reported Event|PRO-157 TID (3 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295488|NCT02980523|EG002|Reported Event|PRO-157 QID (4 Times Per Day)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)~PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295489|NCT02980523|EG003|Reported Event|Moxifloxacin (Vigamox®)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)~Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11332609|NCT03497845|OG002|Outcome|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10848244|NCT00289211|BG000|Baseline|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
10848245|NCT00289211|BG001|Baseline|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
11295490|NCT02980523|EG004|Reported Event|Gatifloxacin (Zymar®)|"60 eyes will be evaluated with the following therapeutic regimen:~instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.~15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)~Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution~Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution"
11295491|NCT02980601|BG000|Baseline|Integra and a Split Thickness Skin Graft (STSG)|"A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.~Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG~STSG: 0.012mm STSG"
11295492|NCT02980601|BG001|Baseline|Split Thickness Skin Graft (STSG)|"reconstruction as dictated by the protocol. They will either receive 1) a 0~STSG: 0.012mm STSG"
11295493|NCT02980601|BG002|Baseline|Total|Total of all reporting groups
11295494|NCT02980601|FG000|Participant Flow|Integra and a Split Thickness Skin Graft (STSG)|"A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.~Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG~STSG: 0.012mm STSG"
11295495|NCT02980601|FG001|Participant Flow|Split Thickness Skin Graft (STSG)|"reconstruction as dictated by the protocol. They will either receive 1) a 0~STSG: 0.012mm STSG"
11295496|NCT02980601|OG000|Outcome|Integra and a Split Thickness Skin Graft (STSG)|"A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.~Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG~STSG: 0.012mm STSG"
11295497|NCT02980601|OG001|Outcome|Split Thickness Skin Graft (STSG)|"reconstruction as dictated by the protocol. They will either receive 1) a 0~STSG: 0.012mm STSG"
11295498|NCT02980601|EG000|Reported Event|Integra and a Split Thickness Skin Graft (STSG)|"A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.~Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG~STSG: 0.012mm STSG"
11295499|NCT02980601|EG001|Reported Event|Split Thickness Skin Graft (STSG)|"reconstruction as dictated by the protocol. They will either receive 1) a 0~STSG: 0.012mm STSG"
11295500|NCT02980692|BG000|Baseline|SUNPG1623 I|Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks
11295501|NCT02980692|BG001|Baseline|SUNPG1623 II|Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295502|NCT02980692|BG002|Baseline|SUNPG1623 Dose III|Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295503|NCT02980692|BG003|Baseline|SUNPG1623 Dose IV|Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295504|NCT02980692|BG004|Baseline|Placebo|Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295505|NCT02980692|BG005|Baseline|Total|Total of all reporting groups
11295506|NCT02980692|FG000|Participant Flow|SUNPG1623 I|Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks
11295507|NCT02980692|FG001|Participant Flow|SUNPG1623 II|Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295508|NCT02980692|FG002|Participant Flow|SUNPG1623 Dose III|Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295509|NCT02980692|FG003|Participant Flow|SUNPG1623 Dose IV|Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295510|NCT02980692|FG004|Participant Flow|Placebo|Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295511|NCT02980692|OG000|Outcome|SUNPG1623 I|Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks
11295512|NCT02980692|OG001|Outcome|SUNPG1623 II|Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295513|NCT02980692|OG002|Outcome|SUNPG1623 Dose III|Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295514|NCT02980692|OG003|Outcome|SUNPG1623 Dose IV|Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295515|NCT02980692|OG004|Outcome|Placebo|Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295516|NCT02980692|OG001|Outcome|SUNPG1623 II|Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks
11295517|NCT02980692|EG000|Reported Event|SUNPG1623 I|Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks
10848246|NCT00289211|BG002|Baseline|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
11295518|NCT02980692|EG001|Reported Event|SUNPG1623 II|Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295519|NCT02980692|EG002|Reported Event|SUNPG1623 Dose III|Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295520|NCT02980692|EG003|Reported Event|SUNPG1623 Dose IV|Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295521|NCT02980692|EG004|Reported Event|Placebo|Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks
11295522|NCT02980705|BG000|Baseline|SUNPG1622 I|SUNPG1622 I dose: Injection
11295523|NCT02980705|BG001|Baseline|Placebo|Placebo dose: Injection
11295524|NCT02980705|BG002|Baseline|Total|Total of all reporting groups
11295525|NCT02980705|FG000|Participant Flow|SUNPG1622 I|SUNPG1622 I dose: Injection
11295526|NCT02980705|FG001|Participant Flow|Placebo|Placebo dose: Injection
11295527|NCT02980705|OG000|Outcome|SUNPG1622 I|SUNPG1622 I dose: Injection
11295528|NCT02980705|OG001|Outcome|Placebo|Placebo dose: Injection
11295529|NCT02980705|EG000|Reported Event|Part 1: SUNPG1622 or Placebo|"Group 1: SUNPG1622 or Placebo; From Baseline to Week 24.~Safety results are provided per the following:~Group 1: Subjects recieved either SUNPG1622 or Placebo"
11295530|NCT02980705|EG001|Reported Event|Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)|"Group 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52.~Safety results are provided per the following:~Group 2: Subjects recieved SUNPG1622"
11295531|NCT02980705|EG002|Reported Event|Part 3: Washout|"Group 3: Washout period between Week 52 and Week 72.~Safety results are provided per the following:~Group 3: washout period"
11295532|NCT02980783|BG000|Baseline|Juvéderm® VOLIFT®™ With Lidocaine|Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
11295533|NCT02980783|FG000|Participant Flow|Juvéderm® VOLIFT®™ With Lidocaine|Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
11295534|NCT02980783|OG000|Outcome|Juvéderm® VOLIFT®™ With Lidocaine|Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
10848247|NCT00289211|BG003|Baseline|Total|Total of all reporting groups
10848248|NCT00289211|FG000|Participant Flow|C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
11295535|NCT02980783|EG000|Reported Event|Juvéderm® VOLIFT®™ With Lidocaine|Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
11295536|NCT02980874|BG000|Baseline|Active|"IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295537|NCT02980874|BG001|Baseline|Control|"IVT aflibercept (2 mg/0.05 mL) + sham SC procedure~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295538|NCT02980874|BG002|Baseline|Total|Total of all reporting groups
11295539|NCT02980874|FG000|Participant Flow|Active|"IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295540|NCT02980874|FG001|Participant Flow|Control|"IVT aflibercept (2 mg/0.05 mL) + sham SC procedure~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295541|NCT02980874|OG000|Outcome|Active|"IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295542|NCT02980874|OG001|Outcome|Control|"IVT aflibercept (2 mg/0.05 mL) + sham SC procedure~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295543|NCT02980874|EG000|Reported Event|Active|"IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295544|NCT02980874|EG001|Reported Event|Control|"IVT aflibercept (2 mg/0.05 mL) + sham SC procedure~suprachoroidal sham: suprachoroidal sham procedure~IVT aflibercept: 2 mg intravitreal injection of aflibercept"
11295545|NCT02980978|BG000|Baseline|Intervention|"Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals~Coaching: Focus on nutrition, activity and appropriate medication use and adherence"
11295546|NCT02980978|BG001|Baseline|Standard of Care|Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
11295547|NCT02980978|BG002|Baseline|Total|Total of all reporting groups
11295548|NCT02980978|FG000|Participant Flow|Intervention|"Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals~Coaching: Focus on nutrition, activity and appropriate medication use and adherence"
11295549|NCT02980978|FG001|Participant Flow|Standard of Care|Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
11295550|NCT02980978|OG000|Outcome|Intervention|"Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals~Coaching: Focus on nutrition, activity and appropriate medication use and adherence"
11295551|NCT02980978|OG001|Outcome|Standard of Care|Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
11295552|NCT02980978|EG000|Reported Event|Intervention|"Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals~Coaching: Focus on nutrition, activity and appropriate medication use and adherence"
11295553|NCT02980978|EG001|Reported Event|Standard of Care|Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
11295554|NCT02981342|BG000|Baseline|150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)|Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.
11295555|NCT02981342|BG001|Baseline|200mg Abemaciclib|Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.
11295556|NCT02981342|BG002|Baseline|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.
11295557|NCT02981342|BG003|Baseline|Gemcitabine or Capecitabine|Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.
11295558|NCT02981342|BG004|Baseline|Total|Total of all reporting groups
11295559|NCT02981342|FG000|Participant Flow|150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)|Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.
11295560|NCT02981342|FG001|Participant Flow|200mg Abemaciclib|Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.
11295561|NCT02981342|FG002|Participant Flow|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.
11295562|NCT02981342|FG003|Participant Flow|Gemcitabine or Capecitabine|Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.
11295563|NCT02981342|OG000|Outcome|200mg Abemaciclib|Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.
11295564|NCT02981342|OG001|Outcome|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.
11295565|NCT02981342|OG002|Outcome|Gemcitabine or Capecitabine|Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.
11295566|NCT02981342|OG000|Outcome|150mg Abemaciclib + 150mg Galunisertib|Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.
11295567|NCT02981342|OG000|Outcome|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.
11295568|NCT02981342|OG000|Outcome|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib twice daily along with 150mg LY3023414 twice daily for 28 day cycles.
11295569|NCT02981342|EG000|Reported Event|150mg Abemaciclib + 150mg Galunisertib (Safety Lead - In)|Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.
11295570|NCT02981342|EG001|Reported Event|200mg Abemaciclib|Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.
11295571|NCT02981342|EG002|Reported Event|150mg Abemaciclib + 150mg LY3023414|Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.
11295572|NCT02981342|EG003|Reported Event|Gemcitabine or Capecitabine|Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.
11295573|NCT02981368|BG000|Baseline|High Risk Prostate Cancer (Cohort A)|Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295574|NCT02981368|BG001|Baseline|Recurrent or Metastatic Prostate Cancer (Cohort B)|Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295575|NCT02981368|BG002|Baseline|Total|Total of all reporting groups
10971174|NCT00914589|FG002|Participant Flow|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
10971175|NCT00914589|OG000|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
10971176|NCT00914589|OG001|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
10971177|NCT00914589|OG002|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
10971178|NCT00914589|EG000|Reported Event|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
10971179|NCT00914589|EG001|Reported Event|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
10971180|NCT00914589|EG002|Reported Event|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
10971181|NCT00914628|BG000|Baseline|A - Experimental Arm|patients received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg), followed by the infusion of HSV-TK genetically modified CD3+ cells In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
10971182|NCT00914628|BG001|Baseline|B- Comparator Arm|the physician chose whether the patient received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or an unmanipulated haploidentical bone marrow or peripheral blood transplant followed by high-dose cyclophosphamide.
10971183|NCT00914628|BG002|Baseline|Total|Total of all reporting groups
10971184|NCT00914628|FG000|Participant Flow|A-Experimental Arm|"Patients received an infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) followed by the infusion of HSV-TK genetically modified CD3+ cells. In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.~HSV-TK engineering donor Lymphocytes"
11295576|NCT02981368|FG000|Participant Flow|High Risk Prostate Cancer (Cohort A)|Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
10971185|NCT00914628|FG001|Participant Flow|B - Control Arm|The physician could choose between the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or unmanipulated haploidentical transplantation (bone marrow or peripheral blood) followed by high-dose cyclophosphamide.
10971186|NCT00914628|OG000|Outcome|A-Experimental Arm|"Patients received an infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) followed by the infusion of HSV-TK genetically modified CD3+ cells. In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.~HSV-TK engineering donor Lymphocytes"
10971187|NCT00914628|OG001|Outcome|B - Control Arm|The physician could choose between the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or unmanipulated haploidentical transplantation (bone marrow or peripheral blood) followed by high-dose cyclophosphamide.
10971188|NCT00914628|OG000|Outcome|A - Experimental Arm|Patients received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg), followed by the infusion of HSV-TK genetically modified CD3+ cells In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
10971189|NCT00914628|OG001|Outcome|B- Comparator Arm|the physician chose whether the patient received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or an unmanipulated haploidentical bone marrow or peripheral blood transplant followed by high-dose cyclophosphamide.
10971190|NCT00914628|OG000|Outcome|A - Experimental Arm|patients received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg), followed by the infusion of HSV-TK genetically modified CD3+ cells In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
10971191|NCT00914628|OG001|Outcome|B - Comparator Arm|The physician chose whether the patient received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or an unmanipulated haploidentical bone marrow or peripheral blood transplant followed by high-dose cyclophosphamide.
10971192|NCT00914628|EG000|Reported Event|A-Experimental Arm|"Analysis performed only on Standard Population so, all randomized patients who received at least an infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) followed by the infusion of HSV-TK genetically modified CD3.~A total of 53/80 were included in the analysis"
10971193|NCT00914628|EG001|Reported Event|B - Control Arm|"Analysis performed only on Standard Population. The physician could choose between the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or unmanipulated haploidentical transplantation (bone marrow or peripheral blood) followed by high-dose cyclophosphamide.~A total of 27/80 were included in the analysis"
10971194|NCT00914732|BG000|Baseline|Lyophilized, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.
10971195|NCT00914732|BG001|Baseline|Liquid, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.
10971196|NCT00914732|BG002|Baseline|Liquid, Intradermal|Participants receive a 2 dose regimen of IMVAMUNE® (2x10^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
10971197|NCT00914732|BG003|Baseline|Total|Total of all reporting groups
10971198|NCT00914732|FG000|Participant Flow|Lyophilized, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.
10971199|NCT00914732|FG001|Participant Flow|Liquid, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.
10971200|NCT00914732|FG002|Participant Flow|Liquid, Intradermal|Participants receive a 2 dose regimen of IMVAMUNE® (2x10^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
11295577|NCT02981368|FG001|Participant Flow|Recurrent or Metastatic Prostate Cancer (Cohort B)|Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295578|NCT02981368|OG000|Outcome|High Risk Prostate Cancer (Cohort A)|High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295579|NCT02981368|OG000|Outcome|Cohort A - Follow-up Value: Low|Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
11295580|NCT02981368|OG001|Outcome|Cohort B - Follow-up Value: Low|Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
11295581|NCT02981368|OG002|Outcome|Cohort A - Follow-up Value: Normal|Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
11295582|NCT02981368|OG003|Outcome|Cohort B - Follow-up Value Normal|Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
11295583|NCT02981368|OG004|Outcome|Cohort A - Follow-up Value: High|Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
11295584|NCT02981368|OG005|Outcome|Cohort B - Follow-up Value: High|Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
11295585|NCT02981368|OG006|Outcome|Cohort A - Follow-up Value: Missing|Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
11295586|NCT02981368|OG007|Outcome|Cohort B - Follow-up Value: Missing|Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
10971201|NCT00914732|OG000|Outcome|Lyophilized, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.
11295587|NCT02981368|OG001|Outcome|Cohort B - Follow-up Value: Low|Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
11295588|NCT02981368|OG003|Outcome|Cohort B - Follow-up Value: Normal|Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
11295589|NCT02981368|OG005|Outcome|Cohort B - Follow-up Value: High|Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
11295590|NCT02981368|OG007|Outcome|Cohort B - Follow-up Value: Missing|Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
11295591|NCT02981368|OG000|Outcome|High Risk Prostate Cancer (Cohort A) - Baseline ECG|High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.
10971202|NCT00914732|OG001|Outcome|Liquid, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.
10971203|NCT00914732|OG000|Outcome|Liquid, Intradermal|Participants receive a 2 dose regimen of IMVAMUNE® (2x10^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
11295592|NCT02981368|OG001|Outcome|High Risk Prostate Cancer (Cohort A) - Post-dosing ECG|High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
11295593|NCT02981368|OG002|Outcome|Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG|Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295594|NCT02981368|OG003|Outcome|Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG|Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
11295595|NCT02981368|OG000|Outcome|High Risk Prostate Cancer (Cohort A)|High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295596|NCT02981368|OG001|Outcome|Recurrent or Metastatic Prostate Cancer (Cohort B)|Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295597|NCT02981368|OG000|Outcome|Recurrent or Metastatic Prostate Cancer (Cohort B)|Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295598|NCT02981368|OG000|Outcome|Cohort A - Conventional Imaging|High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.
11295599|NCT02981368|OG001|Outcome|Cohort A - 18F-DCFPyL PET/CT: Reader 1|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295600|NCT02981368|OG002|Outcome|Cohort A - 18F-DCFPyL PET/CT: Reader 2|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295601|NCT02981368|OG003|Outcome|Cohort A - 18F-DCFPyL PET/CT: Reader 3|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295602|NCT02981368|OG004|Outcome|Cohort B - Conventional Imaging|Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.
11295603|NCT02981368|OG005|Outcome|Cohort B - 18F-DCFPyL PET/CT: Reader 1|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295604|NCT02981368|OG006|Outcome|Cohort B - 18F-DCFPyL PET/CT: Reader 2|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295605|NCT02981368|OG007|Outcome|Cohort B - 18F-DCFPyL PET/CT: Reader 3|One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
11295606|NCT02981368|OG000|Outcome|Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)|A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.
11295607|NCT02981368|EG000|Reported Event|High Risk Prostate Cancer (Cohort A)|Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295608|NCT02981368|EG001|Reported Event|Recurrent or Metastatic Prostate Cancer (Cohort B)|Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
11295609|NCT02981524|BG000|Baseline|CY/GVAX With Pembrolizumab|"During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells.~CY: CY is administered intravenously at 200 mg/m2~GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting~Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg"
11295610|NCT02981524|FG000|Participant Flow|CY/GVAX With Pembrolizumab|"During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells.~CY: CY is administered intravenously at 200 mg/m2~GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting~Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg"
11295611|NCT02981524|OG000|Outcome|CY/GVAX With Pembrolizumab|"During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells.~CY: CY is administered intravenously at 200 mg/m2~GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting~Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg"
10848249|NCT00289211|FG001|Participant Flow|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
11295612|NCT02981524|EG000|Reported Event|CY/GVAX With Pembrolizumab|"During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells.~CY: CY is administered intravenously at 200 mg/m2~GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting~Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg"
11295613|NCT02981602|BG000|Baseline|Cohort 1 GSK3228836 150 mg|Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295614|NCT02981602|BG001|Baseline|Cohort 2 and Cohort 3 GSK3228836 300 mg|Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295615|NCT02981602|BG002|Baseline|Cohorts 1-3 Placebo|Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295616|NCT02981602|BG003|Baseline|Cohort 4 GSK3228836 300 mg|Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295617|NCT02981602|BG004|Baseline|Cohort 4 Placebo|Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295618|NCT02981602|BG005|Baseline|Total|Total of all reporting groups
11295619|NCT02981602|FG000|Participant Flow|Cohort 1 GSK3228836 150 mg|Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295620|NCT02981602|FG001|Participant Flow|Cohort 2 and Cohort 3 GSK3228836 300 mg|Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295621|NCT02981602|FG002|Participant Flow|Cohorts 1-3 Placebo|Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295622|NCT02981602|FG003|Participant Flow|Cohort 4 GSK3228836 300 mg|Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295623|NCT02981602|FG004|Participant Flow|Cohort 4 Placebo|Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295624|NCT02981602|OG000|Outcome|Cohort 1 GSK3228836 150 mg|Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295625|NCT02981602|OG001|Outcome|Cohort 2 and Cohort 3 GSK3228836 300 mg|Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295626|NCT02981602|OG002|Outcome|Cohorts 1-3 Placebo|Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295627|NCT02981602|OG003|Outcome|Cohort 4 GSK3228836 300 mg|Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295628|NCT02981602|OG004|Outcome|Cohort 4 Placebo|Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295629|NCT02981602|OG002|Outcome|Cohort 4 GSK3228836 300 mg|Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295630|NCT02981602|EG000|Reported Event|Cohort 1 GSK3228836 150 mg|Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295631|NCT02981602|EG001|Reported Event|Cohort 2 and Cohort 3 GSK3228836 300 mg|Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295632|NCT02981602|EG002|Reported Event|Cohorts 1-3 Placebo|Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh.
10822231|NCT00075478|FG001|Participant Flow|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
11295633|NCT02981602|EG003|Reported Event|Cohort 4 GSK3228836 300 mg|Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295634|NCT02981602|EG004|Reported Event|Cohort 4 Placebo|Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh.
11295635|NCT02981953|BG000|Baseline|Cardioband Tricuspid Procedure|"Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance~Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance."
11295636|NCT02981953|FG000|Participant Flow|Cardioband Tricuspid Procedure|"Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance~Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance."
11295637|NCT02981953|OG000|Outcome|Cardioband Tricuspid Procedure|"Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance~Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance."
11295638|NCT02981953|EG000|Reported Event|Cardioband Tricuspid Procedure|"Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance~Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance."
11295639|NCT02982018|BG000|Baseline|Senofilcon A With New UV Blocker|Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.
11295640|NCT02982018|BG001|Baseline|Senofilcon A|Subjects that wore the senofilcon A lens throughout the entire duration of the study.
11295641|NCT02982018|BG002|Baseline|Total|Total of all reporting groups
11295642|NCT02982018|FG000|Participant Flow|Senofilcon A With New UV Blocker|Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.
11295643|NCT02982018|FG001|Participant Flow|Senofilcon A|Subjects that wore the senofilcon A lens throughout the entire duration of the study.
11295644|NCT02982018|OG000|Outcome|Senofilcon A With New UV Blocker (Test)|Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.
11295645|NCT02982018|OG001|Outcome|Senofilcon A (Control)|Subjects that wore the senofilcon A lens for the first 12 weeks of the study.
11295646|NCT02982018|EG000|Reported Event|Senofilcon A With New UV Blocker|Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.
11295647|NCT02982018|EG001|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens throughout the entire duration of the study.
11295648|NCT02982187|BG000|Baseline|Sub Study 1: ELLIPTA vs DISKUS + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295649|NCT02982187|BG001|Baseline|Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295650|NCT02982187|BG002|Baseline|Total|Total of all reporting groups
11295651|NCT02982187|FG000|Participant Flow|ELLIPTA/DISKUS+HandiHaler/Q1|Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by preference questionnaire (PQ) 1. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295652|NCT02982187|FG001|Participant Flow|ELLIPTA/DISKUS+HandiHaler/Q2|Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295653|NCT02982187|FG002|Participant Flow|DISKUS+HandiHaler/ELLIPTA/Q1|Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1 respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
10971204|NCT00914732|OG002|Outcome|Liquid, Intradermal|Participants receive a 2 dose regimen of IMVAMUNE® (2x10^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
10971205|NCT00914732|EG000|Reported Event|Lyophilized, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.
10971206|NCT00914732|EG001|Reported Event|Liquid, Subcutaneous|Participants receive a 2 dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.
10971207|NCT00914732|EG002|Reported Event|Liquid, Intradermal|Participants receive a 2 dose regimen of IMVAMUNE® (2x10^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
10971208|NCT00914810|BG000|Baseline|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
10971209|NCT00914810|BG001|Baseline|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
11216838|NCT02309411|OG000|Outcome|Rivaroxaban, Suspension, BID, Age: 2-6 Years|Subjects aged from 2 to 6 years were administered with age- and body weight-adjusted dose of rivaroxaban (BAY59-7939) oral suspension twice daily (BID) under fed conditions for 30 days.
10971210|NCT00914810|BG002|Baseline|Total|Total of all reporting groups
10971211|NCT00914810|FG000|Participant Flow|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
10971212|NCT00914810|FG001|Participant Flow|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
10971213|NCT00914810|OG000|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
10971214|NCT00914810|OG001|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
10971215|NCT00914810|EG000|Reported Event|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
10971216|NCT00914810|EG001|Reported Event|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
10971217|NCT00914849|BG000|Baseline|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
11216839|NCT02309411|OG001|Outcome|Rivaroxaban Suspension, BID, Age: 6 Months-2 Years|Subjects aged from 6 months to 2 years were administered with age- and body weight-adjusted dose of rivaroxaban oral suspension BID under fed conditions for 30 days.
11216840|NCT02309411|EG000|Reported Event|Rivaroxaban BID (Suspension) (2 - 6 Years Group)|Subjects aged from 2 to 6 years were administered with age- and body weight-adjusted dose of rivaroxaban oral suspension BID under fed conditions for 30 days.
11216841|NCT02309411|EG001|Reported Event|Rivaroxaban BID (Suspension) (6 Months - 2 Years Group)|Subjects aged from 6 months to 2 years were administered with age- and body weight-adjusted dose of rivaroxaban oral suspension BID under fed conditions for 30 days.
11216842|NCT02309411|EG002|Reported Event|Anticoagulants, Comparator (2 - 6 Years Group)|Subjects aged from 2 to 6 years were received comparator as per standard of care.
11216843|NCT02309489|BG000|Baseline|Intervention|"Receive standard maternity care~Woman and partner attend one extra couple counselling session during pregnancy (A)~Partner attends one group education session for men (B)~Partner participates in pre-discharge consultation (C)~Partner involvement: Partner is involved in maternity care"
11216844|NCT02309489|BG001|Baseline|Control|"Receive standard maternity care~No active encouragement of partner involvement, no extra sessions offered"
11216845|NCT02309489|BG002|Baseline|Total|Total of all reporting groups
11216846|NCT02309489|FG000|Participant Flow|Intervention|"Receive standard maternity care~Woman and partner attend one extra couple counselling session during pregnancy (A)~Partner attends one group education session for men (B)~Partner participates in pre-discharge consultation (C)~Partner involvement: Partner is involved in maternity care"
11216847|NCT02309489|FG001|Participant Flow|Control|"Receive standard maternity care~No active encouragement of partner involvement, no extra sessions offered"
11216848|NCT02309489|OG000|Outcome|Intervention|"Receive standard maternity care~Woman and partner attend one extra couple counselling session during pregnancy (A)~Partner attends one group education session for men (B)~Partner participates in pre-discharge consultation (C)~Partner involvement: Partner is involved in maternity care"
11216849|NCT02309489|OG001|Outcome|Control|"Receive standard maternity care~No active encouragement of partner involvement, no extra sessions offered"
11216850|NCT02309489|EG000|Reported Event|Intervention|"Receive standard maternity care~Woman and partner attend one extra couple counselling session during pregnancy (A)~Partner attends one group education session for men (B)~Partner participates in pre-discharge consultation (C)~Partner involvement: Partner is involved in maternity care"
11216851|NCT02309489|EG001|Reported Event|Control|"Receive standard maternity care~No active encouragement of partner involvement, no extra sessions offered"
11216852|NCT02309515|BG000|Baseline|Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)|Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.
11216853|NCT02309515|BG001|Baseline|Arm II (Pneumococcal 13-valent Conjugate Vaccine)|Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
11216854|NCT02309515|BG002|Baseline|Total|Total of all reporting groups
11216855|NCT02309515|FG000|Participant Flow|Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)|Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.
11216856|NCT02309515|FG001|Participant Flow|Arm II (Pneumococcal 13-valent Conjugate Vaccine)|Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
11216857|NCT02309515|OG000|Outcome|Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)|Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.
11216858|NCT02309515|OG001|Outcome|Arm II (Pneumococcal 13-valent Conjugate Vaccine)|Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
11216859|NCT02309515|EG000|Reported Event|Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)|Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.
11216860|NCT02309515|EG001|Reported Event|Arm II (Pneumococcal 13-valent Conjugate Vaccine)|Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
11295654|NCT02982187|FG003|Participant Flow|DISKUS+HandiHaler/ELLIPTA/Q2|Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295655|NCT02982187|FG004|Participant Flow|ELLIPTA/Turbuhaler+HandiHaler/Q3|Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295656|NCT02982187|FG005|Participant Flow|ELLIPTA/Turbuhaler+HandiHaler/Q4|Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295657|NCT02982187|FG006|Participant Flow|Turbuhaler+HandiHaler/ELLIPTA/Q3|Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295658|NCT02982187|FG007|Participant Flow|Turbuhaler+HandiHaler/ELLIPTA/Q4|Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295659|NCT02982187|OG000|Outcome|Sub-study 1 : ELLIPTA|Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
11295660|NCT02982187|OG001|Outcome|Sub-study 1 : DISKUS + HandiHaler|Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
11295661|NCT02982187|OG002|Outcome|Sub-study 2 : ELLIPTA|Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
11295662|NCT02982187|OG003|Outcome|Sub-study 2 : Turbuhaler + HandiHaler|Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
11295663|NCT02982187|OG000|Outcome|Sub Study 1: ELLIPTA vs DISKUS + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295664|NCT02982187|OG001|Outcome|Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295665|NCT02982187|EG000|Reported Event|Sub Study 1: ELLIPTA vs DISKUS + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295666|NCT02982187|EG001|Reported Event|Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler|Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
11295667|NCT02982213|BG000|Baseline|No Companion Present|No companion is present during the placement of the epidural catheter.
11295668|NCT02982213|BG001|Baseline|Companion Present|"A companion will be present during the placement of the epidural catheter.~Companion Present: A companion will be present during the epidural catheter placement."
11295669|NCT02982213|BG002|Baseline|Total|Total of all reporting groups
11295670|NCT02982213|FG000|Participant Flow|No Companion Present|No companion is present during the placement of the epidural catheter.
11295671|NCT02982213|FG001|Participant Flow|Companion Present|"A companion will be present during the placement of the epidural catheter.~Companion Present: A companion will be present during the epidural catheter placement."
11295672|NCT02982213|OG000|Outcome|No Companion Present|No companion is present during the placement of the epidural catheter.
10848250|NCT00289211|FG002|Participant Flow|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
11295673|NCT02982213|OG001|Outcome|Companion Present|"A companion will be present during the placement of the epidural catheter.~Companion Present: A companion will be present during the epidural catheter placement."
11295674|NCT02982213|EG000|Reported Event|No Companion|No companion in the room during the procedure
11295675|NCT02982213|EG001|Reported Event|Companion Present|Companion present during the procedure
10848251|NCT00289211|OG000|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
11295676|NCT02982239|BG000|Baseline|Intervention|Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
11295677|NCT02982239|BG001|Baseline|Intervention -Tech|Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
11295678|NCT02982239|BG002|Baseline|Total|Total of all reporting groups
11295679|NCT02982239|FG000|Participant Flow|Intervention- No Tech|Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
11295680|NCT02982239|FG001|Participant Flow|Intervention -Tech|Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
11295681|NCT02982239|OG000|Outcome|Intervention|Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
11295682|NCT02982239|OG001|Outcome|Intervention -Tech|Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
11295683|NCT02982239|OG000|Outcome|Intervention- No Tech|Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
11295684|NCT02982239|EG000|Reported Event|Intervention|Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
11295685|NCT02982239|EG001|Reported Event|Intervention -Tech|Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
11295686|NCT02982590|BG000|Baseline|Warfarin Sodium|"warfarin daily, dosage according to INR monitor. Aim INR 2-3~Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus"
11295687|NCT02982590|BG001|Baseline|Apixaban|"Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.~Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication."
11295688|NCT02982590|BG002|Baseline|Total|Total of all reporting groups
11295689|NCT02982590|FG000|Participant Flow|Warfarin Sodium|"warfarin daily, dosage according to INR monitor. Aim INR 2-3~Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus"
11295690|NCT02982590|FG001|Participant Flow|Apixaban|"Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.~Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication."
11295691|NCT02982590|OG000|Outcome|Warfarin Sodium|"Warfarin daily, dosage according to INR monitor. Aim INR 2-3~Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus"
11295692|NCT02982590|OG001|Outcome|Apixaban|"Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.~Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication."
11295693|NCT02982590|EG000|Reported Event|Warfarin Sodium|"Warfarin daily, dosage according to INR monitor. Aim INR 2-3~Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus"
11295694|NCT02982590|EG001|Reported Event|Apixaban|"Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.~Apixaban 5 MG Oral Tablet [ELIQUIS]: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication."
11295695|NCT02982772|BG000|Baseline|Tailored Combination Therapy|"Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.~Combination Therapy: Brief Behavioral Intervention~The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
11295696|NCT02982772|BG001|Baseline|Standard Care Intervention|"Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.~Standard Flavored gums will be used as needed for 10 weeks.~Standard Care Intervention: Brief Behavioral Intervention~The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.~Standard Flavored Gums for 10 weeks"
11295697|NCT02982772|BG002|Baseline|Total|Total of all reporting groups
11295698|NCT02982772|FG000|Participant Flow|Tailored Combination Therapy|"Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.~Combination Therapy: Brief Behavioral Intervention~The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
11295699|NCT02982772|FG001|Participant Flow|Standard Care Intervention|"Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.~Standard Flavored gums will be used as needed for 10 weeks.~Standard Care Intervention: Brief Behavioral Intervention~The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.~Standard Flavored Gums for 10 weeks"
11295700|NCT02982772|OG000|Outcome|Tailored Combination Therapy|"Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.~Combination Therapy: Brief Behavioral Intervention~The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
11295701|NCT02982772|OG001|Outcome|Standard Care Intervention|"Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.~Standard Flavored gums will be used as needed for 10 weeks.~Standard Care Intervention: Brief Behavioral Intervention~The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.~Standard Flavored Gums for 10 weeks"
11295702|NCT02982772|OG000|Outcome|Tailored Combination Therapy|"Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.~Doses will be tailored and adjust as need it~Combination Therapy: Brief behavioral intervention~The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
10971218|NCT00914849|BG001|Baseline|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
10971219|NCT00914849|BG002|Baseline|Total|Total of all reporting groups
10971220|NCT00914849|FG000|Participant Flow|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg intravenous (IV)~Leukopheresis~Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
10971221|NCT00914849|FG001|Participant Flow|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
10971222|NCT00914849|OG000|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
10971223|NCT00914849|OG001|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
10971224|NCT00914849|EG000|Reported Event|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
10971225|NCT00914849|EG001|Reported Event|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
10971226|NCT00914862|BG000|Baseline|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
10971227|NCT00914862|BG001|Baseline|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
10971228|NCT00914862|BG002|Baseline|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
10971229|NCT00914862|BG003|Baseline|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
10971230|NCT00914862|BG004|Baseline|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
10971231|NCT00914862|BG005|Baseline|Total|Total of all reporting groups
10971232|NCT00914862|FG000|Participant Flow|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
10971233|NCT00914862|FG001|Participant Flow|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
10971234|NCT00914862|FG002|Participant Flow|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
10971235|NCT00914862|FG003|Participant Flow|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
10971236|NCT00914862|FG004|Participant Flow|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
11216861|NCT02309723|BG000|Baseline|Positive Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.
11216862|NCT02309723|BG001|Baseline|Negative Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.
11216863|NCT02309723|BG002|Baseline|No Beta Amyloid Information|Survey respondents presented scenario with no beta amyloid information.
11216864|NCT02309723|BG003|Baseline|Total|Total of all reporting groups
11216865|NCT02309723|FG000|Participant Flow|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
11216866|NCT02309723|FG001|Participant Flow|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
11216867|NCT02309723|FG002|Participant Flow|No Beta Amyloid Information|
11216868|NCT02309723|OG000|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
11216869|NCT02309723|OG001|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
11216870|NCT02309723|OG002|Outcome|No Beta Amyloid Information|
11216871|NCT02309723|EG000|Reported Event|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
11216872|NCT02309723|EG001|Reported Event|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
11216873|NCT02309723|EG002|Reported Event|No Beta Amyloid Information|
11216874|NCT02309944|BG000|Baseline|Standard Wound Closure|Standard surgical closure of the fascia and skin.
11216875|NCT02309944|BG001|Baseline|Negative Pressure Wound Therapy|Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
11216876|NCT02309944|BG002|Baseline|Total|Total of all reporting groups
11216877|NCT02309944|FG000|Participant Flow|Standard Wound Closure|Standard surgical closure of the fascia and skin.
11216878|NCT02309944|FG001|Participant Flow|Negative Pressure Wound Therapy|Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
11216879|NCT02309944|OG000|Outcome|Standard Wound Closure|Standard surgical closure of the fascia and skin.
11216880|NCT02309944|OG001|Outcome|Negative Pressure Wound Therapy|Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
11216881|NCT02309944|EG000|Reported Event|Standard Wound Closure|Standard surgical closure of the fascia and skin.
11216882|NCT02309944|EG001|Reported Event|Negative Pressure Wound Therapy|Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
11216883|NCT02310100|BG000|Baseline|TactiCath Quartz|Ablation with TactiCath Quartz
11216884|NCT02310100|FG000|Participant Flow|TactiCath Quartz|Patients undergoing elective catheter ablation for symptomatic paroxysmal AF that was refractory or intolerant to at least one Class I-IV antiarrhythmic drug
11216885|NCT02310100|OG000|Outcome|TactiCath Quartz|Ablation using TactiCath Quartz
11216886|NCT02310100|OG000|Outcome|TactiCath Quartz|TactiCath Quartz treatment
11216887|NCT02310100|EG000|Reported Event|TactiCath Quartz|Ablation with TactiCath Quartz
11216888|NCT02310126|BG000|Baseline|Etafilcon A(Multi-focal)/ Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.
11216889|NCT02310126|BG001|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
11216890|NCT02310126|BG002|Baseline|Total|Total of all reporting groups
11216891|NCT02310126|FG000|Participant Flow|Etafilcon A(Multi-focal)/Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.
11216892|NCT02310126|FG001|Participant Flow|Etafilcon A(Sphere)/Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
11216893|NCT02310126|OG000|Outcome|Etafilcon A(Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
11216894|NCT02310126|OG001|Outcome|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
11216895|NCT02310126|EG000|Reported Event|Etafilcon A (Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
11216896|NCT02310126|EG001|Reported Event|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
11216897|NCT02310568|BG000|Baseline|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11216898|NCT02310568|BG001|Baseline|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
11216899|NCT02310568|BG002|Baseline|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
11216900|NCT02310568|BG003|Baseline|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11295703|NCT02982772|OG001|Outcome|Standard Care Intervention|"Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.~Standard Flavored gums will be used as needed for 10 weeks.~Standard Care Intervention: Brief Behavioral Intervention~The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.~Standard Flavored Gums for 10 weeks"
11295704|NCT02982772|EG000|Reported Event|Tailored Combination Therapy|"Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.~Doses will be tailored and adjust as need it~Combination Therapy: Brief behavioral intervention~The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
11295705|NCT02982772|EG001|Reported Event|Standard Care Intervention|"Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.~Standard Flavored gums will be used as needed for 10 weeks.~Standard Care Intervention: Brief Behavioral Intervention~The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.~Standard Flavored Gums for 10 weeks"
11295706|NCT02982863|BG000|Baseline|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295707|NCT02982863|BG001|Baseline|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295708|NCT02982863|BG002|Baseline|Apixaban|Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295709|NCT02982863|BG003|Baseline|Rivaroxaban|Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295710|NCT02982863|BG004|Baseline|Edoxaban|Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295711|NCT02982863|BG005|Baseline|Total|Total of all reporting groups
11295712|NCT02982863|FG000|Participant Flow|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295713|NCT02982863|FG001|Participant Flow|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295714|NCT02982863|FG002|Participant Flow|Apixaban|Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295715|NCT02982863|FG003|Participant Flow|Rivaroxaban|Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295716|NCT02982863|FG004|Participant Flow|Edoxaban|Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295717|NCT02982863|OG000|Outcome|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295718|NCT02982863|OG001|Outcome|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295719|NCT02982863|OG002|Outcome|Apixaban|Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295720|NCT02982863|OG003|Outcome|Rivaroxaban|Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295721|NCT02982863|OG004|Outcome|Edoxaban|Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295722|NCT02982863|OG000|Outcome|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295723|NCT02982863|OG000|Outcome|Rivaroxaban|Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295724|NCT02982863|OG000|Outcome|Apixaban|Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295725|NCT02982863|OG000|Outcome|Edoxaban|Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295726|NCT02982863|EG000|Reported Event|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295727|NCT02982863|EG001|Reported Event|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295728|NCT02982863|EG002|Reported Event|Apixaban|Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295729|NCT02982863|EG003|Reported Event|Rivaroxaban|Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295730|NCT02982863|EG004|Reported Event|Edoxaban|Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11295731|NCT02982928|BG000|Baseline|Bariatric Surgery|Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
11295732|NCT02982928|FG000|Participant Flow|Bariatric Surgery|Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
11295733|NCT02982928|OG000|Outcome|Bariatric Surgery|Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
11295734|NCT02982928|EG000|Reported Event|Bariatric Surgery|Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
11295735|NCT02983058|BG000|Baseline|Subjects With Psychotic Spectrum Disorders|Subjects who met DSM-5 diagnostic criteria for psychotic disorder and had genetic confirmation of carrying CNTNAP2 mutation
11295736|NCT02983058|BG001|Baseline|Unaffected Relatives|Unaffected 1st or 2nd degree relatives of subjects who have psychotic spectrum disorder and carries the CNTNAP2 mutation. Unaffected relatives do not carry CNTNAP2 mutation
11295737|NCT02983058|BG002|Baseline|Total|Total of all reporting groups
11295738|NCT02983058|FG000|Participant Flow|Subjects With Psychotic Spectrum Disorders|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295739|NCT02983058|FG001|Participant Flow|Unaffected 1st or 2nd Degree Relatives|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295740|NCT02983058|OG000|Outcome|Subjects With Psychotic Spectrum Disorders|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295741|NCT02983058|OG001|Outcome|Unaffected 1st or 2nd Degree Relatives|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295742|NCT02983058|EG000|Reported Event|Subjects With Psychotic Spectrum Disorders|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295743|NCT02983058|EG001|Reported Event|Unaffected 1st or 2nd Degree Relatives|"PET/SPECT scan will be used to evaluate the utility of mGluR5 binding as a biomarker of the CNTNAP2 mutation and related mTOR kinase pathway dysregulation. 30 minutes structural MRI will be obtained to permit co-registration of PET images.~PET/SPECT Scan: PET scan will be performed on a mCT scanner~MRI Scan: Structural MRI will be obtained to permit co-registration of PET images"
11295744|NCT02983227|BG000|Baseline|GDC-0853 (200mg BID) Cohort 1|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
11295745|NCT02983227|BG001|Baseline|GDC-0853 (200mg BID) Cohort 2|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
11295746|NCT02983227|BG002|Baseline|Total|Total of all reporting groups
11295747|NCT02983227|FG000|Participant Flow|GDC-0853 (200mg BID) Cohort 1|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
11295748|NCT02983227|FG001|Participant Flow|GDC-0853 (200mg BID) Cohort 2|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
11295749|NCT02983227|OG000|Outcome|GDC-0853 (200mg BID) Cohort 1|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
11295750|NCT02983227|OG001|Outcome|GDC-0853 (200mg BID) Cohort 2|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
11295751|NCT02983227|EG000|Reported Event|GDC-0853 (200mg BID) Cohort 1|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
11295752|NCT02983227|EG001|Reported Event|GDC-0853 (200mg BID) Cohort 2|Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
11295753|NCT02983305|BG000|Baseline|Retinal Dystrophy|"Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295754|NCT02983305|BG001|Baseline|Healthy Age-Matched Controls|"Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295755|NCT02983305|BG002|Baseline|Total|Total of all reporting groups
11295756|NCT02983305|FG000|Participant Flow|Retinal Dystrophy|"Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295757|NCT02983305|FG001|Participant Flow|Healthy Age-Matched Controls|"Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295758|NCT02983305|OG000|Outcome|Retinal Dystrophy|"Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295759|NCT02983305|OG001|Outcome|Healthy Age-Matched Controls|"Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295760|NCT02983305|EG000|Reported Event|Retinal Dystrophy|"Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
10848252|NCT00289211|OG001|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
10848253|NCT00289211|EG000|Reported Event|C1INH-nf|
10848254|NCT00289211|EG001|Reported Event|Placebo|
10971237|NCT00914862|OG000|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
11216901|NCT02310568|BG004|Baseline|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11216902|NCT02310568|BG005|Baseline|Total|Total of all reporting groups
11216903|NCT02310568|FG000|Participant Flow|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11216904|NCT02310568|FG001|Participant Flow|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
11216905|NCT02310568|FG002|Participant Flow|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
11216906|NCT02310568|FG003|Participant Flow|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11216907|NCT02310568|FG004|Participant Flow|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11216908|NCT02310568|OG000|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11216909|NCT02310568|OG001|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11216910|NCT02310568|OG002|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11216911|NCT02310568|OG003|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11216912|NCT02310568|OG004|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216913|NCT02310568|OG005|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216914|NCT02310568|OG000|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11216915|NCT02310568|OG001|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216916|NCT02310568|OG002|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216917|NCT02310568|OG000|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11216918|NCT02310568|OG001|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11216919|NCT02310568|OG000|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216920|NCT02310568|OG001|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11216921|NCT02310568|EG000|Reported Event|Placebo|All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
11216922|NCT02310568|EG001|Reported Event|PF-06372865 2.5 mg|All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
11216923|NCT02310568|EG002|Reported Event|PF-06372865 7.5 mg|All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
11216924|NCT02310581|BG000|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
11216925|NCT02310581|BG001|Baseline|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
11216926|NCT02310581|BG002|Baseline|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
11216927|NCT02310581|BG003|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
11216928|NCT02310581|BG004|Baseline|Total|Total of all reporting groups
11216929|NCT02310581|FG000|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
11216930|NCT02310581|FG001|Participant Flow|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
11216931|NCT02310581|FG002|Participant Flow|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
11216932|NCT02310581|FG003|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
11216933|NCT02310581|OG000|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
11216934|NCT02310581|OG001|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
11295761|NCT02983305|EG001|Reported Event|Healthy Age-Matched Controls|"Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.~Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye."
11295762|NCT02983448|BG000|Baseline|All Participants|All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
11295763|NCT02983448|FG000|Participant Flow|Sham Stimulation First|"Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.~Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295764|NCT02983448|FG001|Participant Flow|Active Stimulation First|"Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.~Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295765|NCT02983448|OG000|Outcome|Sham Stimulation|"Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.~Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295766|NCT02983448|OG001|Outcome|Active Stimulation|"Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.~Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295767|NCT02983448|OG000|Outcome|Sham Stimulation|All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
11295768|NCT02983448|OG001|Outcome|Active Stimulation|All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
11295769|NCT02983448|EG000|Reported Event|Sham Intervention|"Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.~Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295770|NCT02983448|EG001|Reported Event|Active Intervention|"Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.~Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.~transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized"
11295771|NCT02983552|BG000|Baseline|Binocular Computer Game Treatment Older Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
10848255|NCT00289276|BG000|Baseline|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
11295772|NCT02983552|BG001|Baseline|Continued Spectacle Correction Older Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295773|NCT02983552|BG002|Baseline|Binocular Computer Game Treatment Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295774|NCT02983552|BG003|Baseline|Continued Spectacle Correction Younger Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295775|NCT02983552|BG004|Baseline|Total|Total of all reporting groups
11295776|NCT02983552|FG000|Participant Flow|Binocular Computer Game Treatment- Older Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295777|NCT02983552|FG001|Participant Flow|Continued Spectacle Correction- Older Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295778|NCT02983552|FG002|Participant Flow|Binocular Computer Game Treatment- Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295779|NCT02983552|FG003|Participant Flow|Continued Spectacle Correction- Younger Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295780|NCT02983552|OG000|Outcome|Binocular Computer Game Treatment Older Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295781|NCT02983552|OG001|Outcome|Continued Spectacle Correction Older Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295782|NCT02983552|OG000|Outcome|Binocular Computer Game Treatment Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295783|NCT02983552|OG001|Outcome|Continued Spectacle Correction Younger Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295784|NCT02983552|OG002|Outcome|Binocular Computer Game Treatment Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295785|NCT02983552|OG003|Outcome|Continued Spectacle Correction Younger Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295786|NCT02983552|OG003|Outcome|Continued Spectacle Correction Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295787|NCT02983552|OG001|Outcome|Binocular Computer Game Treatment Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295788|NCT02983552|EG000|Reported Event|Binocular Computer Game Treatment Older Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295789|NCT02983552|EG001|Reported Event|Continued Spectacle Correction Older Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295790|NCT02983552|EG002|Reported Event|Binocular Computer Game Treatment Younger Cohort|"Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)~iPad®: Binocular therapy using a Dig Rush application on an iPad®"
11295791|NCT02983552|EG003|Reported Event|Continued Spectacle Correction Younger Cohort|"Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.~Spectacle correction: Spectacle correction for all waking hours, 7 days per week"
11295792|NCT02983604|BG000|Baseline|GS-5829 4 mg + Exemestane|GS-5829 4 mg tablets once daily + exemestane 25 mg tablet once daily
11295793|NCT02983604|BG001|Baseline|GS-5829 4 mg + Fulvestrant|GS-5829 4 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
10971238|NCT00914862|OG001|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
11295794|NCT02983604|BG002|Baseline|GS-5829 6 mg + Fulvestrant|GS-5829 6 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295795|NCT02983604|BG003|Baseline|GS-5829 9 mg + Fulvestrant|GS-5829 9 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295796|NCT02983604|BG004|Baseline|Total|Total of all reporting groups
11295797|NCT02983604|FG000|Participant Flow|GS-5829 4 mg + Exemestane|GS-5829 4 mg tablets once daily + exemestane 25 mg tablet once daily
11295798|NCT02983604|FG001|Participant Flow|GS-5829 4 mg + Fulvestrant|GS-5829 4 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295799|NCT02983604|FG002|Participant Flow|GS-5829 6 mg + Fulvestrant|GS-5829 6 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295800|NCT02983604|FG003|Participant Flow|GS-5829 9 mg + Fulvestrant|GS-5829 9 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295801|NCT02983604|OG000|Outcome|GS-5829 4 mg + Exemestane|GS-5829 4 mg tablets once daily + exemestane 25 mg tablet once daily
11295802|NCT02983604|OG001|Outcome|GS-5829 4 mg + Fulvestrant|GS-5829 4 mg tablets once daily + fulvestrant 500 mg administered intramuscularly on Days 1, 15, and 29, and then every 28 days (or in accordance with locally approved labeling)
11295803|NCT02983604|OG002|Outcome|GS-5829 6 mg + Fulvestrant|GS-5829 6 mg tablets once daily + fulvestrant 500 mg administered intramuscularly on Days 1, 15, and 29, and then every 28 days (or in accordance with locally approved labeling)
11295804|NCT02983604|OG003|Outcome|GS-5829 9 mg + Fulvestrant|GS-5829 9 mg tablets once daily + fulvestrant 500 mg administered intramuscularly on Days 1, 15, and 29, and then every 28 days (or in accordance with locally approved labeling)
11295805|NCT02983604|EG000|Reported Event|GS-5829 4 mg + Exemestane|GS-5829 4 mg tablets once daily + exemestane 25 mg tablet once daily
11295806|NCT02983604|EG001|Reported Event|GS-5829 4 mg + Fulvestrant|GS-5829 4 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295807|NCT02983604|EG002|Reported Event|GS-5829 6 mg + Fulvestrant|GS-5829 6 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
11295808|NCT02983604|EG003|Reported Event|GS-5829 9 mg + Fulvestrant|GS-5829 9 mg tablets once daily + fulvestrant 500 mg administered intramuscularly every 28 days (± 3 days)
10971239|NCT00914862|OG002|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
11295809|NCT02983825|BG000|Baseline|Continuous Positive Airway Pressure (CPAP) Level Changes|"Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline~Continuous positive airway pressure (CPAP); level changes: as per arm description"
11295810|NCT02983825|FG000|Participant Flow|Continuous Positive Airway Pressure (CPAP) Level Changes|"Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline~Continuous positive airway pressure (CPAP); level changes: as per arm description"
11295811|NCT02983825|OG000|Outcome|Continuous Positive Airway Pressure (CPAP) Level Changes|"Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline~Continuous positive airway pressure (CPAP); level changes: as per arm description"
11295812|NCT02983825|EG000|Reported Event|Continuous Positive Airway Pressure (CPAP) Level Changes|"Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline~Continuous positive airway pressure (CPAP); level changes: as per arm description"
11295813|NCT02983877|BG000|Baseline|iTAB-CV|"In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention.~iTAB-CV Stage 1: Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention."
11295814|NCT02983877|FG000|Participant Flow|iTAB-CV|"In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention. Stage 1 lasts one month.~Stage two of iTAB-CV includes the addition of customized context cues/reminders and immediate reinforcement for medication taking behavior in addition to 1 daily motivational mood rating. The number of texts per day will be determined based on the number of times a day that medications are prescribed (up to four a day). Stage two lasts one month."
11295815|NCT02983877|OG000|Outcome|Whole Sample|These analyses were run on the entire sample as a whole, N= 38.
11295816|NCT02983877|OG000|Outcome|Whole Sample|These analyses were run on the entire sample as a whole. For this measure, two participants were missing data so the total N=36 instead of 38.
11295817|NCT02983877|EG000|Reported Event|iTAB-CV|Participants received alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention.
11295818|NCT02983981|BG000|Baseline|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray applied twice daily for 4 weeks followed by twice daily BID on two consecutive days a week (e.g. Saturday and Sunday) for 12 weeks."
11295819|NCT02983981|FG000|Participant Flow|Topicort Topical Spray|Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
11295820|NCT02983981|OG000|Outcome|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
11295821|NCT02983981|EG000|Reported Event|Open Label|"Topicort topical spray~Topicort Topical Spray: open label Topicort spray"
11295822|NCT02984267|BG000|Baseline|Ultrasound Group|"The interventional group that will have their spine evaluated by ultrasound prior to epidural placement~Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement"
10971240|NCT00914862|OG003|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
11295823|NCT02984267|BG001|Baseline|Palpation Group|"The control group that will have their epidural placed in the usual fashion based on palpation~Palpation: Using palpation only to evaluate the spine prior to epidural placement"
11295824|NCT02984267|BG002|Baseline|Total|Total of all reporting groups
11295825|NCT02984267|FG000|Participant Flow|Ultrasound Group|"The interventional group that will have their spine evaluated by ultrasound prior to epidural placement~Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement"
11295826|NCT02984267|FG001|Participant Flow|Palpation Group|"The control group that will have their epidural placed in the usual fashion based on palpation~Palpation: Using palpation only to evaluate the spine prior to epidural placement"
11295827|NCT02984267|OG000|Outcome|Ultrasound Group|"The interventional group that will have their spine evaluated by ultrasound prior to epidural placement~Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement"
11295828|NCT02984267|OG001|Outcome|Palpation Group|"The control group that will have their epidural placed in the usual fashion based on palpation~Palpation: Using palpation only to evaluate the spine prior to epidural placement"
11295829|NCT02984267|EG000|Reported Event|Ultrasound Group|"The interventional group that will have their spine evaluated by ultrasound prior to epidural placement~Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement"
11295830|NCT02984267|EG001|Reported Event|Palpation Group|"The control group that will have their epidural placed in the usual fashion based on palpation~Palpation: Using palpation only to evaluate the spine prior to epidural placement"
11295831|NCT02984644|BG000|Baseline|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days."
11295832|NCT02984644|BG001|Baseline|Placebo|"Subjects will receive placebo~Placebo: Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days."
11295833|NCT02984644|BG002|Baseline|Total|Total of all reporting groups
10971241|NCT00914862|OG004|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
11295834|NCT02984644|FG000|Participant Flow|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days."
11295835|NCT02984644|FG001|Participant Flow|Placebo|"Subjects will receive placebo~Placebo: Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days."
11295836|NCT02984644|OG000|Outcome|Dapagliflozin 10mg|Change in plasma glucose concentration to show effect of Dapagliflozin on EGP (endogenous glucose production)
11295837|NCT02984644|OG001|Outcome|Placebo|Change in plasma glucose concentration after placebo administration
11295838|NCT02984644|OG000|Outcome|Dapagliflozin 10mg|Change in plasma glucose concentration to show effect of Dapagliflozin on EGP (endogenous glucose production) using a glucose clamp
11295839|NCT02984644|OG001|Outcome|Placebo|Change in plasma glucose concentration after placebo administration using a glucose clamp
11295840|NCT02984644|OG000|Outcome|Dapagliflozin 10mg|Change in plasma glucose concentration to show effect of Dapagliflozin on plasma glucose concentration
11295841|NCT02984644|OG000|Outcome|Dapagliflozin|"Subjects will receive dapagliflozin 10mg~Dapagliflozin: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days."
11295842|NCT02984644|OG001|Outcome|Placebo|"Subjects will receive placebo~Placebo: Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days."
11295843|NCT02984644|OG000|Outcome|Dapagliflozin 10mg|Change in EGP (endogenous glucose production) after dapagliflozin administration
11295844|NCT02984644|OG001|Outcome|Placebo|Change in EGP concentration after placebo administration
11295845|NCT02984644|OG000|Outcome|Dapagliflozin 10mg|Change in EGP (endogenous glucose production) after dapagliflozin administration using a pancreatic clamp
11295846|NCT02984644|OG001|Outcome|Placebo|Change in EGP concentration after placebo administration using a pancreatic clamp
10971242|NCT00914862|EG000|Reported Event|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
10971243|NCT00914862|EG001|Reported Event|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
11295847|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma insulin level is measured at baseline minus the last hour of the study.
11295848|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma insulin level is measured at baseline minus the last hour of the study.
11295849|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma insulin level is measured at baseline minus the last hour of the study while using glucose clamp.
11295850|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma insulin level is measured at baseline minus the last hour of the study while using glucose clamp.
11295851|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma insulin level is measured at baseline minus the last hour of the study while using pancreatic clamp.
11295852|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma insulin level is measured at baseline minus the last hour of the study while using pancreatic clamp.
11295853|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma glucagon level is measured at baseline minus the last hour of the study.
11295854|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma glucagon level is measured at baseline minus the last hour of the study.
11295855|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma glucagon level is measured at baseline minus the last hour of the study while using a glucose clamp.
11295856|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma glucagon level is measured at baseline minus the last hour of the study while using a glucose clamp.
11295857|NCT02984644|OG000|Outcome|Dapagliflozin|Subjects will receive dapagliflozin 10mg. Change in plasma glucagon level is measured at baseline minus the last hour of the study while using a pancreatic clamp.
11295858|NCT02984644|OG001|Outcome|Placebo|Subjects will receive placebo. Change in plasma glucagon level is measured at baseline minus the last hour of the study while using a pancreatic clamp.
11295859|NCT02984644|EG000|Reported Event|Dapagliflozin|"20 subjects will receive dapagliflozin 10mg~Dapagliflozin: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days."
11295860|NCT02984644|EG001|Reported Event|Placebo|"10 subjects will receive placebo~Placebo: Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days."
11295861|NCT02984683|BG000|Baseline|SAR566658 90 mg/m^2|Participants received SAR566658 90 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295862|NCT02984683|BG001|Baseline|SAR566658 120 mg/m^2|Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295863|NCT02984683|BG002|Baseline|Total|Total of all reporting groups
11295864|NCT02984683|FG000|Participant Flow|SAR566658 90 mg/m^2|Participants received SAR566658 90 milligram per square meter (mg/m^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295865|NCT02984683|FG001|Participant Flow|SAR566658 120 mg/m^2|Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295866|NCT02984683|OG000|Outcome|SAR566658 90 mg/m^2|Participants received SAR566658 90 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295867|NCT02984683|OG001|Outcome|SAR566658 120 mg/m^2|Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295868|NCT02984683|EG000|Reported Event|SAR566658 90 mg/m^2|Participants received SAR566658 90 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
10971244|NCT00914862|EG002|Reported Event|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
10971245|NCT00914862|EG003|Reported Event|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
11216935|NCT02310581|OG002|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
11216936|NCT02310581|OG003|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
11216937|NCT02310581|EG000|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
11216938|NCT02310581|EG001|Reported Event|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
11216939|NCT02310581|EG002|Reported Event|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
11216940|NCT02310581|EG003|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
11216941|NCT02310646|BG000|Baseline|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
11216942|NCT02310646|BG001|Baseline|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
11216943|NCT02310646|BG002|Baseline|Total|Total of all reporting groups
11216944|NCT02310646|FG000|Participant Flow|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11216945|NCT02310646|FG001|Participant Flow|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11216946|NCT02310646|OG000|Outcome|All Randomised Subjects|All randomised subjects (foam - gel and gel - foam)
11216947|NCT02310646|OG001|Outcome|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
11216948|NCT02310646|OG002|Outcome|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
11216949|NCT02310646|OG000|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
11216950|NCT02310646|OG001|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
11216951|NCT02310646|OG000|Outcome|Latest Topical Treatment|Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline. Assessments of last topical treatment (TPUQ tool) at baseline.
11216952|NCT02310646|OG001|Outcome|LEO 90100 Aerosol Foam|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to Baseline.~Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 aerosol foam assessments from the foam-gel group as well as the gel-foam group."
11216953|NCT02310646|OG002|Outcome|Daivobet® Gel|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline.~Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group."
11216954|NCT02310646|OG000|Outcome|All Subjects Foam|Subject assessments of LEO 90100 aerosol foam compared to latest topical treatment (CLTT analysis set).
11216955|NCT02310646|OG001|Outcome|All Subjects Gel|Subject assessments of Daivobet® gel compared to latest topical treatment (CLTT analysis set).
11216956|NCT02310646|OG000|Outcome|Prefer Foam - Very Important Factor|Subjects who prefer foam
11216957|NCT02310646|OG001|Outcome|Prefer Foam - Fairly Important Factor|Subjects who prefer foam
11216958|NCT02310646|OG002|Outcome|Prefer Foam - Not Very Important Factor|Subjects who prefer foam
11216959|NCT02310646|OG003|Outcome|Prefer Foam - Not at All Important Factor|Subjects who prefer foam
11216960|NCT02310646|OG004|Outcome|Prefer Gel - Very Important Factor|Subjects who prefer gel
11216961|NCT02310646|OG005|Outcome|Prefer Gel - Fairly Important Factor|Subjects who prefer gel
11216962|NCT02310646|OG006|Outcome|Prefer Gel - Not Very Important Factor|Subjects who prefer gel
11216963|NCT02310646|OG007|Outcome|Prefer Gel - Not at All Important Factor|Subjects who prefer gel
11216964|NCT02310646|EG000|Reported Event|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11216965|NCT02310646|EG001|Reported Event|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11216966|NCT02310672|BG000|Baseline|Macitentan 10 mg|Participants received macitentan 10 milligrams (mg) tablets once daily until the premature discontinuation of study drug or end of treatment (EOT) on the day of the last dose of study drug at Week 52.
11216967|NCT02310672|FG000|Participant Flow|Macitentan 10 mg|Participants received macitentan 10 milligrams (mg) tablets once daily until the premature discontinuation of study drug or end of treatment (EOT) on the day of the last dose of study drug at Week 52.
11216968|NCT02310672|OG000|Outcome|Macitanten 10 mg|Participants received macitentan 10 milligrams (mg) tablets once daily until the premature discontinuation of study drug or end of treatment (EOT) on the day of the last dose of study drug at Week 52.
11295869|NCT02984683|EG001|Reported Event|SAR566658 120 mg/m^2|Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
11295870|NCT02984709|BG000|Baseline|Experimental: Positive Psychology Intervention|The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295871|NCT02984709|BG001|Baseline|Active Comparator: Education Group|The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
11295872|NCT02984709|BG002|Baseline|Total|Total of all reporting groups
11295873|NCT02984709|FG000|Participant Flow|Experimental: Positive Psychology Intervention|Adolescents randomized to the positive psychology group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295874|NCT02984709|FG001|Participant Flow|Active Comparator: Education Group|Adolescents randomized to the education group will be given developmentally appropriate diabetes education material at the time of enrollment.
11295875|NCT02984709|OG000|Outcome|Experimental: Positive Psychology Intervention|The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295876|NCT02984709|OG001|Outcome|Active Comparator: Education Group|The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
11295877|NCT02984709|OG000|Outcome|Positive Psychology Intervention|The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. Self-Affirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295878|NCT02984709|OG001|Outcome|Education Group|The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295879|NCT02984709|EG000|Reported Event|Experimental: Positive Psychology Intervention|The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. SelfAffirmation). Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.
11295880|NCT02984709|EG001|Reported Event|Active Comparator: Education Group|The education group will be given developmentally appropriate diabetes education material at the time of enrollment.
11295881|NCT02984878|BG000|Baseline|Revanesse Ultra Retreatment|Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score, were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 30 returned to baseline
11295882|NCT02984878|BG001|Baseline|Revanesse Ultra Optimal Correction|"Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects as needed for optimal correction if WSRS scores had not returned to baseline.~The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) were treated as needed for optimal correction if WSRS scores had not returned to baseline, and were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 41 were included in the optimal correction group"
11295883|NCT02984878|BG002|Baseline|Total|Total of all reporting groups
11295884|NCT02984878|FG000|Participant Flow|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
11295885|NCT02984878|FG001|Participant Flow|Revanesse Ultra Optimal Correction|The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
10971246|NCT00914862|EG004|Reported Event|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
11295886|NCT02984878|OG000|Outcome|Optimal Correction Group|Optional Open label Retreatment at Week 24 / SYM2014-02 Retreatment: At SYM 2014-02 Main Study Visit 6/Week 24, a subject could be retreated with Revanesse Ultra. Subjects were eligible for optimal correction when WSRS scores had not returned to baseline. Optimal Correction subjects were injected in either one or both NLFs as needed to achieve optimal correction. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
11295887|NCT02984878|OG001|Outcome|Retreatment Group|Revanesse Ultra open label retreatment for Nasolabial Fold correction. Optional Open-label Retreatment at Visit 6/Week 24 of the SYM 2014-02 Main Study, a subject could be retreated when WSRS scores had returned to baseline for either or both NLFs. The retreatment group and the optimal correction group were separated for data analysis. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
11295888|NCT02984878|OG000|Outcome|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
11295889|NCT02984878|OG001|Outcome|Revanesse Ultra Optimal Correction|The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
11295890|NCT02984878|OG000|Outcome|Revanesse Ultra Retreatment|Revanesse Ultra: Nasolabial Fold correction - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline
11295891|NCT02984878|EG000|Reported Event|Retreatment Group|Revanesse Ultra open label retreatment for Nasolabial Fold correction. Optional Open-label Retreatment at Visit 6/Week 24 of the SYM 2014-02 Main Study, a subject could be retreated when WSRS scores had returned to baseline for either or both NLFs. The retreatment group and the optimal correction group were separated for data analysis. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
11295892|NCT02984878|EG001|Reported Event|Optimal Correction Group|Optional Open label Retreatment at Week 24 / SYM2014-02 Retreatment: At SYM 2014-02 Main Study Visit 6/Week 24, a subject could be retreated with Revanesse Ultra. Subjects were eligible for optimal correction when WSRS scores had not returned to baseline. Optimal Correction subjects were injected in either one or both NLFs as needed to achieve optimal correction. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52).
11295893|NCT02984943|BG000|Baseline|Hyperbaric Oxygen|Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.
11295894|NCT02984943|FG000|Participant Flow|Hyperbaric Oxygen|Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.
11295895|NCT02984943|OG000|Outcome|Hyperbaric Oxygen|30 treatments of Hyperbaric Oxygen.
11295896|NCT02984943|EG000|Reported Event|Hyperbaric Oxygen|30 treatments of Hyperbaric Oxygen.
10822232|NCT00075478|OG000|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
11295897|NCT02984982|BG000|Baseline|Standard of Care|During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
11295898|NCT02984982|BG001|Baseline|Alirocumab|Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
11295899|NCT02984982|BG002|Baseline|Total|Total of all reporting groups
11295900|NCT02984982|FG000|Participant Flow|Standard of Care|During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin greater than or equal to [>=] 10 milligram per day [mg/day] or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-proprotein convertase subtilisin kexin type 9 (non-PCSK9) inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if low-density lipoprotein cholesterol (LDL-C) target level less than (<) 100 milligrams per deciliter (mg/dL) could not be achieved.
11295901|NCT02984982|FG001|Participant Flow|Alirocumab|Alirocumab (Praluent®) 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
11295902|NCT02984982|OG000|Outcome|Standard of Care|During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
11216969|NCT02310672|EG000|Reported Event|Macitentan 10 mg|Participants received macitentan 10 milligrams (mg) tablets once daily until the premature discontinuation of study drug or end of treatment (EOT) on the day of the last dose of study drug at Week 52.
11216970|NCT02310750|BG000|Baseline|PF--06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11216971|NCT02310750|BG001|Baseline|PF--06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11216972|NCT02310750|BG002|Baseline|PF--06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216973|NCT02310750|BG003|Baseline|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216974|NCT02310750|BG004|Baseline|PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
11216975|NCT02310750|BG005|Baseline|PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216976|NCT02310750|BG006|Baseline|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
11216977|NCT02310750|BG007|Baseline|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11216978|NCT02310750|BG008|Baseline|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11216979|NCT02310750|BG009|Baseline|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11216980|NCT02310750|BG010|Baseline|PF-06700841: 100 mg Food Effect Cohort|All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study.
11216981|NCT02310750|BG011|Baseline|Total|Total of all reporting groups
11216982|NCT02310750|FG000|Participant Flow|PF--06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11216983|NCT02310750|FG001|Participant Flow|PF--06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11216984|NCT02310750|FG002|Participant Flow|PF--06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216985|NCT02310750|FG003|Participant Flow|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216986|NCT02310750|FG004|Participant Flow|PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
11216987|NCT02310750|FG005|Participant Flow|PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
11216988|NCT02310750|FG006|Participant Flow|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
11216989|NCT02310750|FG007|Participant Flow|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11295903|NCT02984982|OG001|Outcome|Alirocumab|Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
11295904|NCT02984982|OG000|Outcome|Standard of Care|During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 milligram per day [mg/day] or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
11295905|NCT02984982|EG000|Reported Event|Standard of Care|During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
11295906|NCT02984982|EG001|Reported Event|Alirocumab|Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
11295907|NCT02984995|BG000|Baseline|Initial Dose 30 mg/Day Quizartinib|Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
11295908|NCT02984995|BG001|Baseline|Initial Dose 20 mg/Day Quizartinib|Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
11295909|NCT02984995|BG002|Baseline|Total|Total of all reporting groups
11295910|NCT02984995|FG000|Participant Flow|Initial Dose 30 mg/Day Quizartinib|Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
11295911|NCT02984995|FG001|Participant Flow|Initial Dose 20 mg/Day Quizartinib|Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
11295912|NCT02984995|OG000|Outcome|Initial Dose 30 mg/Day Quizartinib|Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
11295913|NCT02984995|OG001|Outcome|Initial Dose 20 mg/Day Quizartinib|Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
11295914|NCT02984995|OG002|Outcome|Total|All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
11295915|NCT02984995|OG000|Outcome|Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)|Patients who received a CYP3A4 strong inhibitor received quizartinib 20 mg/day and escalated to 30 mg/day at Day 15.
11295916|NCT02984995|OG001|Outcome|Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)|Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
11295917|NCT02984995|OG002|Outcome|Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)|Patients who received a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
11295918|NCT02984995|OG003|Outcome|Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)|Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
11295919|NCT02984995|EG000|Reported Event|Initial Dose 30 mg/Day Quizartinib|Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
11295920|NCT02984995|EG001|Reported Event|Initial 20 mg/Day Quizartinib|Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
11295921|NCT02984995|EG002|Reported Event|Total|All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
11295922|NCT02985021|BG000|Baseline|Treatment (Docetaxel, Carboplatin)|"Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.~Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.~Carboplatin: Chemotherapy~Docetaxel: Chemotherapy"
11295923|NCT02985021|FG000|Participant Flow|Treatment (Docetaxel, Carboplatin)|"Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.~Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.~Carboplatin: Chemotherapy~Docetaxel: Chemotherapy"
11295924|NCT02985021|OG000|Outcome|Treatment (Docetaxel, Carboplatin)|"Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.~Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.~Carboplatin: Chemotherapy~Docetaxel: Chemotherapy"
11295925|NCT02985021|EG000|Reported Event|Treatment (Docetaxel, Carboplatin)|"Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.~Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.~Carboplatin: Chemotherapy~Docetaxel: Chemotherapy"
11295926|NCT02985398|BG000|Baseline|300 mg ALD403|Participants were randomized to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
10971247|NCT00914927|BG000|Baseline|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
11295927|NCT02985398|FG000|Participant Flow|300 mg ALD403|Participants were enrolled and scheduled to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
11295928|NCT02985398|OG000|Outcome|300 mg ALD403|Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
11295929|NCT02985398|EG000|Reported Event|300 mg ALD403|Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
11295930|NCT02985450|BG000|Baseline|HBV Vaccine Cohort|Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care.
11295931|NCT02985450|FG000|Participant Flow|HBV Vaccine Cohort|Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care. We followed the product monograph for TWINRIX and Engerix vaccines.
11295932|NCT02985450|OG000|Outcome|BMI < 35|40 patients with BMI < 35
11295933|NCT02985450|OG001|Outcome|BMI > 35|28 patients with BMI > 35
11295934|NCT02985450|OG000|Outcome|BMI < 35|17 patients with BMI < 35 and PBMCs collected for analysis.
11295935|NCT02985450|OG001|Outcome|BMI > 35|14 patients with BMI > 35 and PBMCs collected for analysis.
11295936|NCT02985450|EG000|Reported Event|HBV Vaccine Cohort|Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care.
11295937|NCT02985710|BG000|Baseline|Sudoscan Only|"Patients in this arm will only undergoing testing with Sudoscan.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation."
11295938|NCT02985710|BG001|Baseline|Sudoscan Plus|"Patients in this arm will get Sudoscan testing as well as a skin biopsy and QSART testing.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.~Skin biopsy: For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).~QSART: QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured."
11295939|NCT02985710|BG002|Baseline|Total|Total of all reporting groups
11295940|NCT02985710|FG000|Participant Flow|Sudoscan Only|"Patients in this arm will only undergoing testing with Sudoscan.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation."
11295941|NCT02985710|FG001|Participant Flow|Sudoscan Plus|"Patients in this arm will get Sudoscan testing as well as a skin biopsy and QSART testing.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.~Skin biopsy: For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).~QSART: QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured."
11295942|NCT02985710|OG000|Outcome|Sudoscan Only|"Patients in this arm will only undergoing testing with Sudoscan.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation."
11295943|NCT02985710|OG001|Outcome|Sudoscan Plus|"Patients in this arm will get Sudoscan testing as well as a skin biopsy and QSART testing.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.~Skin biopsy: For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).~QSART: QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured."
11295944|NCT02985710|EG000|Reported Event|Sudoscan Only|"Patients in this arm will only undergoing testing with Sudoscan.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation."
11295945|NCT02985710|EG001|Reported Event|Sudoscan Plus|"Patients in this arm will get Sudoscan testing as well as a skin biopsy and QSART testing.~Sudoscan: The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.~Skin biopsy: For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).~QSART: QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured."
11295946|NCT02985827|BG000|Baseline|Dry Eye Participants|Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295947|NCT02985827|BG001|Baseline|Normal Participants|Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295948|NCT02985827|BG002|Baseline|Total|Total of all reporting groups
11295949|NCT02985827|FG000|Participant Flow|Dry Eye Participants|Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295950|NCT02985827|FG001|Participant Flow|Normal Participants|Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295951|NCT02985827|OG000|Outcome|Dry Eye Participants|Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295952|NCT02985827|OG001|Outcome|Normal Participants|Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.
11295953|NCT02985827|EG000|Reported Event|Dry Eye Participants|Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol.
11295954|NCT02985827|EG001|Reported Event|Normal Participants|Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol.
11295955|NCT02985879|BG000|Baseline|Placebo|0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
11295956|NCT02985879|BG001|Baseline|ABBV-8E12 2000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295957|NCT02985879|BG002|Baseline|ABBV-8E12 4000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295958|NCT02985879|BG003|Baseline|Total|Total of all reporting groups
10848256|NCT00289276|BG001|Baseline|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
10848257|NCT00289276|BG002|Baseline|Total|Total of all reporting groups
10848258|NCT00289276|FG000|Participant Flow|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
10848259|NCT00289276|FG001|Participant Flow|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
10848260|NCT00289276|OG000|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
10848261|NCT00289276|OG001|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
10848262|NCT00289276|EG000|Reported Event|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
10848263|NCT00289276|EG001|Reported Event|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
11295959|NCT02985879|FG000|Participant Flow|Placebo|0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
11295960|NCT02985879|FG001|Participant Flow|ABBV-8E12 2000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295961|NCT02985879|FG002|Participant Flow|ABBV-8E12 4000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295962|NCT02985879|OG000|Outcome|Placebo|0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
10848264|NCT00289289|BG000|Baseline|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
10848265|NCT00289289|BG001|Baseline|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
10848266|NCT00289289|BG002|Baseline|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
10848267|NCT00289289|BG003|Baseline|Total|Total of all reporting groups
10848268|NCT00289289|FG000|Participant Flow|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
10848269|NCT00289289|FG001|Participant Flow|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
10848270|NCT00289289|FG002|Participant Flow|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
11295963|NCT02985879|OG001|Outcome|ABBV-8E12 2000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295964|NCT02985879|OG002|Outcome|ABBV-8E12 4000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295965|NCT02985879|OG000|Outcome|Cohort 1, ABBV-8E12 2000 mg|First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg
11295966|NCT02985879|OG001|Outcome|Cohort 1, ABBV-8E12 4000 mg|First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg
11295967|NCT02985879|OG002|Outcome|Cohort J1, ABBV-8E12 2000 mg|First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg
11295968|NCT02985879|OG003|Outcome|Cohort J1, ABBV-8E12 4000 mg|First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg
11295969|NCT02985879|OG001|Outcome|ABBV-8E12 2000 mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295970|NCT02985879|OG002|Outcome|ABBV-8E12 4000 mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295971|NCT02985879|EG000|Reported Event|Placebo|0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
11295972|NCT02985879|EG001|Reported Event|ABBV-8E12 2000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295973|NCT02985879|EG002|Reported Event|ABBV-8E12 4000mg|Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
11295974|NCT02985996|BG000|Baseline|Phase I/Pre-Drug|Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295975|NCT02985996|BG001|Baseline|Phase II/Genvoya|Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295976|NCT02985996|BG002|Baseline|Phase II/Truvada|Experimental: Phase II/Truvada Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295977|NCT02985996|BG003|Baseline|Phase III/Genvoya|Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295978|NCT02985996|BG004|Baseline|Phase III/Truvada|Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295979|NCT02985996|BG005|Baseline|Total|Total of all reporting groups
11295980|NCT02985996|FG000|Participant Flow|Phase I/Pre-Drug|Participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295981|NCT02985996|FG001|Participant Flow|Phase II/Genvoya|Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295982|NCT02985996|FG002|Participant Flow|Phase II/Truvada|Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295983|NCT02985996|FG003|Participant Flow|Phase III/Genvoya|Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295984|NCT02985996|FG004|Participant Flow|Phase III/Truvada|Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295985|NCT02985996|OG000|Outcome|Phase I/Pre-Drug|Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295986|NCT02985996|OG001|Outcome|Phase II/Genvoya|Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295987|NCT02985996|OG002|Outcome|Phase II/Truvada|Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295988|NCT02985996|OG003|Outcome|Phase III/Genvoya|Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295989|NCT02985996|OG004|Outcome|Phase III/Truvada|Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295990|NCT02985996|OG001|Outcome|Phase II/Genvoya|Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken
11295991|NCT02985996|OG003|Outcome|Phase III/Genvoya|Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken
11295992|NCT02985996|OG001|Outcome|Phase II/Short Course|"Participants will be randomized to receive one dose of Truvada or Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.~Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.~Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet."
11295993|NCT02985996|OG002|Outcome|Phase III/Steady State|"Participants will be randomized to receive Truvada or Genvoya to be taken once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.~Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.~Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet."
11295994|NCT02985996|EG000|Reported Event|Phase I/Pre-Drug|Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295995|NCT02985996|EG001|Reported Event|Phase II/Genvoya|Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295996|NCT02985996|EG002|Reported Event|Phase II/Truvada|Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295997|NCT02985996|EG003|Reported Event|Phase III/Genvoya|Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295998|NCT02985996|EG004|Reported Event|Phase III/Truvada|Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
11295999|NCT02986074|BG000|Baseline|All Subjects|All subjects who were enrolled in the study
11296000|NCT02986074|FG000|Participant Flow|Anatomical Positioning Lead First|"subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead~Anatomical midline lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial"
11296001|NCT02986074|FG001|Participant Flow|Paresthesia Mapping Lead First|"subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead~Paresthesia mapping lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial"
11296002|NCT02986074|FG002|Participant Flow|Follow up Using Paresthesia Mapping Lead Stimulation|Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach
11296003|NCT02986074|FG003|Participant Flow|Follow up Using Anatomical Placement Lead Stimulation|Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach
11296004|NCT02986074|OG000|Outcome|Anatomically Positioned Lead|Stimulation delivered using the anatomical lead
11296005|NCT02986074|OG001|Outcome|Paresthesia Mapping Lead|Stimulation delivered using the paresthesia mapping lead
11296006|NCT02986074|EG000|Reported Event|Anatomically Positioned Leads and Parasthesia Mapped Leads|All subjects enrolled in the study
11296007|NCT02986139|BG000|Baseline|Sequence AB|Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).
11296008|NCT02986139|BG001|Baseline|Sequence BA|Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).
11296009|NCT02986139|BG002|Baseline|Total|Total of all reporting groups
11296010|NCT02986139|FG000|Participant Flow|Sequence AB|Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).
11296011|NCT02986139|FG001|Participant Flow|Sequence BA|Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).
11296012|NCT02986139|OG000|Outcome|Etanercept Commercial Formulation|Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
11296013|NCT02986139|OG001|Outcome|Etanercept New Formulation|Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
11296014|NCT02986139|OG000|Outcome|Etanercept Commercial Formulation - RA|Participants with rheumatoid arthritis (RA) received a single 50 mg SC dose of etanercept commercial formulation.
10848271|NCT00289289|OG000|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
10971248|NCT00914927|BG001|Baseline|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971249|NCT00914927|BG002|Baseline|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971250|NCT00914927|BG003|Baseline|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971251|NCT00914927|BG004|Baseline|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
11296015|NCT02986139|OG001|Outcome|Etanercept Commercial Formulation - PsA|Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept commercial formulation.
11296016|NCT02986139|OG002|Outcome|Etanercept New Formulation - RA|Participants with RA received a single 50 mg SC dose of etanercept new formulation.
11296017|NCT02986139|OG003|Outcome|Etanercept New Formulation - PsA|Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept new formulation.
11296018|NCT02986139|EG000|Reported Event|Etanercept Commercial Formulation|Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.
11296019|NCT02986139|EG001|Reported Event|Etanercept New Formulation|Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.
11296020|NCT02986282|BG000|Baseline|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method."
11296021|NCT02986282|FG000|Participant Flow|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
11296022|NCT02986282|OG000|Outcome|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
10971252|NCT00914927|BG005|Baseline|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
10971253|NCT00914927|BG006|Baseline|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971254|NCT00914927|BG007|Baseline|Total|Total of all reporting groups
10971255|NCT00914927|FG000|Participant Flow|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971256|NCT00914927|FG001|Participant Flow|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971257|NCT00914927|FG002|Participant Flow|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971258|NCT00914927|FG003|Participant Flow|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971259|NCT00914927|FG004|Participant Flow|Cohort B: 0 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
10971260|NCT00914927|FG005|Participant Flow|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
11296023|NCT02986282|EG000|Reported Event|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation~ABI measurement using both doppler and oscillometric method"
11296024|NCT02986373|BG000|Baseline|Risankizumab|Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.
11296025|NCT02986373|FG000|Participant Flow|Risankizumab|Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.
11296026|NCT02986373|OG000|Outcome|Risankizumab|Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.
11296027|NCT02986373|EG000|Reported Event|Risankizumab|Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.
11296028|NCT02986711|BG000|Baseline|Motivational Text Messages|"Motivational text messages to help participants stay quit when they leave the hospital.~Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status"
11296029|NCT02986711|BG001|Baseline|Control|"Text messages to ask about current smoking status.~Control: Only survey questions about smoking status"
11296030|NCT02986711|BG002|Baseline|Total|Total of all reporting groups
11296031|NCT02986711|FG000|Participant Flow|Motivational Text Messages|"Motivational text messages to help participants stay quit when they leave the hospital.~Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status"
11296032|NCT02986711|FG001|Participant Flow|Control|"Text messages to ask about current smoking status.~Control: Only survey questions about smoking status"
11296033|NCT02986711|OG000|Outcome|Motivational Text Messages|"Motivational text messages to help participants stay quit when they leave the hospital.~Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status"
11296034|NCT02986711|OG001|Outcome|Control|"Text messages to ask about current smoking status.~Control: Only survey questions about smoking status"
11296035|NCT02986711|EG000|Reported Event|Motivational Text Messages|"Motivational text messages to help participants stay quit when they leave the hospital.~Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status"
11296036|NCT02986711|EG001|Reported Event|Control|"Text messages to ask about current smoking status.~Control: Only survey questions about smoking status"
11296037|NCT02986802|BG000|Baseline|Genital Herpes Treated Before Third Trimester|Women with genital herpes receiving treatment before the 3rd trimester
10822233|NCT00075478|OG001|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
10971261|NCT00914927|FG006|Participant Flow|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
11296038|NCT02986802|BG001|Baseline|Genital Herpes Treated Only During Third Trimester|Women with genital herpes receiving treatment during the 3rd trimester
11296039|NCT02986802|BG002|Baseline|Genital Herpes Untreated|Women with untreated genital herpes
11296040|NCT02986802|BG003|Baseline|Control Group|Women (controls) with neither genital herpes nor treatment
11296041|NCT02986802|BG004|Baseline|Total|Total of all reporting groups
11296042|NCT02986802|FG000|Participant Flow|Genital Herpes Treated Before Third Trimester|Women with genital herpes receiving treatment before the 3rd trimester
11296043|NCT02986802|FG001|Participant Flow|Genital Herpes Treated Only During Third Trimester|Women with genital herpes receiving treatment during the 3rd trimester
11296044|NCT02986802|FG002|Participant Flow|Genital Herpes Untreated|Women with untreated genital herpes
11296045|NCT02986802|FG003|Participant Flow|Control Group|Women (controls) with neither genital herpes nor treatment
11296046|NCT02986802|OG000|Outcome|Genital Herpes Treated Before Third Trimester|Women with genital herpes receiving treatment before the 3rd trimester
11296047|NCT02986802|OG001|Outcome|Genital Herpes Treated Only During Third Trimester|Women with genital herpes receiving treatment during the 3rd trimester
11296048|NCT02986802|OG002|Outcome|Genital Herpes Untreated|Women with untreated genital herpes
11296049|NCT02986802|OG003|Outcome|Control Group|Women (controls) with neither genital herpes nor treatment
11296050|NCT02986802|EG000|Reported Event|Genital Herpes Treated Before Third Trimester|Women with genital herpes receiving treatment before the 3rd trimester
11296051|NCT02986802|EG001|Reported Event|Genital Herpes Treated Only During Third Trimester|Women with genital herpes receiving treatment during the 3rd trimester
11296052|NCT02986802|EG002|Reported Event|Genital Herpes Untreated|Women with untreated genital herpes
11296053|NCT02986802|EG003|Reported Event|Control Group|Women (controls) with neither genital herpes nor treatment
10971262|NCT00914927|OG000|Outcome|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
11296054|NCT02986854|BG000|Baseline|Menveo-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296055|NCT02986854|BG001|Baseline|Menactra-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296056|NCT02986854|BG002|Baseline|Naive Group|Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
11296057|NCT02986854|BG003|Baseline|Total|Total of all reporting groups
11296058|NCT02986854|FG000|Participant Flow|Menveo-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296059|NCT02986854|FG001|Participant Flow|Menactra-Menveo Group|Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296060|NCT02986854|FG002|Participant Flow|Naive Group|Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
11296061|NCT02986854|OG000|Outcome|Menveo-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296062|NCT02986854|OG001|Outcome|Menactra-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296063|NCT02986854|OG002|Outcome|Pooled Group (Menveo-Menveo and Menactra-Menveo)|Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups
11296064|NCT02986854|OG003|Outcome|Naive Group|Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
11296065|NCT02986854|OG002|Outcome|Pooled Group (Menveo-Menveo and Menactra-Menveo)|Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups.
11296066|NCT02986854|EG000|Reported Event|Menveo-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296067|NCT02986854|EG001|Reported Event|Menactra-Menveo Group|Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
11296068|NCT02986854|EG002|Reported Event|Naive Group|Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
11296069|NCT02986958|BG000|Baseline|Checklist|"One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider~Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist"
11296070|NCT02986958|BG001|Baseline|Usual Care|"Care as usual with their primary care provider~Usual care: routine primary care"
11296071|NCT02986958|BG002|Baseline|Total|Total of all reporting groups
11296072|NCT02986958|FG000|Participant Flow|Checklist|"One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider~Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist"
11296073|NCT02986958|FG001|Participant Flow|Usual Care|"Care as usual with their primary care provider~Usual care: routine primary care"
11296074|NCT02986958|OG000|Outcome|Checklist|"One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider~Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist"
11296075|NCT02986958|OG001|Outcome|Usual Care|"Care as usual with their primary care provider~Usual care: routine primary care"
11296076|NCT02986958|EG000|Reported Event|Checklist|"One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider~Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist"
11296077|NCT02986958|EG001|Reported Event|Usual Care|"Care as usual with their primary care provider~Usual care: routine primary care"
11332610|NCT03497845|OG003|Outcome|l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332611|NCT03497845|EG000|Reported Event|a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332612|NCT03497845|EG001|Reported Event|b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332613|NCT03497845|EG002|Reported Event|c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant|"Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332614|NCT03497845|EG003|Reported Event|d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332615|NCT03497845|EG004|Reported Event|e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332616|NCT03497845|EG005|Reported Event|f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant|"Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332617|NCT03497845|EG006|Reported Event|g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332618|NCT03497845|EG007|Reported Event|h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332619|NCT03497845|EG008|Reported Event|i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant|"Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332620|NCT03497845|EG009|Reported Event|j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant|"Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).~IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11332621|NCT03497845|EG010|Reported Event|k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
11296078|NCT02987205|BG000|Baseline|Split Face Study Bilateral Revanesse Ultra vs Restylane in NLF|Split face study - Revanesse Ultra in the NLF on one side of the face and Restylane on the opposite side of the face for NLF correction, treatment is randomized
11296079|NCT02987205|FG000|Participant Flow|Bilateral Treatment With Revanesse Ultra and Restylane|Randomized treatment with Revanesse Ultra in the Nasolabial Fold (NLF) on one side of the face, and Restylane on the opposite side of the face - the study is a randomized, multicenter, double blind, split-face study in subjects seeking NLF correction. Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane in the NLF on the other side of the face. The side of the face for each product was randomly assigned.
11296080|NCT02987205|OG000|Outcome|Revanesse Ultra|"Revanesse Ultra in the NLF on one side of the face~Revanesse Ultra: NLF correction"
11296081|NCT02987205|OG001|Outcome|Restylane|"Restylane injection in the NLF on the other side of the face to optimal correction~Restylane: NLF Correction"
11296082|NCT02987205|EG000|Reported Event|Revanesse Ultra|"Revanesse Ultra in the NLF on one side of the face~Revanesse Ultra: NLF correction"
11296083|NCT02987205|EG001|Reported Event|Restylane|"Restylane injection in the NLF on the other side of the face to optimal correction~Restylane: NLF Correction"
11296084|NCT02987231|BG000|Baseline|CAF + SHAM|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied"
11296085|NCT02987231|BG001|Baseline|CAF + ES|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~ES: Local electric stimulation for 120 seconds, once a day for a week"
11296086|NCT02987231|BG002|Baseline|Total|Total of all reporting groups
11296087|NCT02987231|FG000|Participant Flow|CAF + SHAM|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied"
11296088|NCT02987231|FG001|Participant Flow|CAF + ES|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~ES: Local electric stimulation for 120 seconds, once a day for a week"
11296089|NCT02987231|OG000|Outcome|CAF + SHAM|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied"
11296090|NCT02987231|OG001|Outcome|CAF + ES|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~ES: Local electric stimulation for 120 seconds, once a day for a week"
11296091|NCT02987231|EG000|Reported Event|CAF + SHAM|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied"
11296092|NCT02987231|EG001|Reported Event|CAF + ES|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.~CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap~ES: Local electric stimulation for 120 seconds, once a day for a week"
11296093|NCT02987374|BG000|Baseline|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
10848272|NCT00289289|OG001|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
10848273|NCT00289289|EG000|Reported Event|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
10848274|NCT00289289|EG001|Reported Event|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
10848275|NCT00289289|EG002|Reported Event|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
11296094|NCT02987374|FG000|Participant Flow|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
11296095|NCT02987374|OG000|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
10848276|NCT00289315|BG000|Baseline|Arm 1|"Primary Prevention of weight gain~Primary weight gain prevention: School-based program that modifies the school environment to promote healthy eating and physical activity~Primary Prevention: School-based environmental program to promote healthy eating and physical activity."
10848277|NCT00289315|BG001|Baseline|Arm 2|"Primary and secondary weight gain prevention program~Primary and Secondary Prevention: School-based program that combines an environmental weight gain prevention program with a curriculum/internet-based program to promote weight loss in overweight students"
10848278|NCT00289315|BG002|Baseline|Arm 3|"Control~Control: Control program that does not include an active intervention for promoting healthy eating and physical activity."
10848279|NCT00289315|BG003|Baseline|Total|Total of all reporting groups
11296096|NCT02987374|EG000|Reported Event|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
11296097|NCT02987621|BG000|Baseline|All Study Participants|"Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.~Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.~The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.~tDCS: Less than 10V of Transcranial Direct Current Stimulation~Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation"
11296098|NCT02987621|FG000|Participant Flow|Sham First, Seven Day Wash Out, Then tDCS|"Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.~Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.~The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.~tDCS: Less than 10V of Transcranial Direct Current Stimulation~Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation"
11296099|NCT02987621|FG001|Participant Flow|tDCS First, 7 Day Wash Out, Then Sham|"Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.~Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.~The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.~tDCS: Less than 10V of Transcranial Direct Current Stimulation~Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation"
11296100|NCT02987621|OG000|Outcome|All Study Participants|"Participants will perform leg muscle strength testing with tDCS. On a separate day they will repeat the leg muscle strength testing with Sham stimulation.~Leg strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Furthermore, participants perform a 6 minute walk.~tDCS: Less than 10V of Transcranial Direct Current Stimulation~Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation"
11296101|NCT02987621|OG000|Outcome|All Study Participants|"Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order.~Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted.~The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors.~tDCS: Less than 10V of Transcranial Direct Current Stimulation~Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation"
11296102|NCT02987621|EG000|Reported Event|All Study Participants-Leg Muscle Strength tDCS|"Knee extensor strength was tested for all study participants with tDCS (less than 10V). All study participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.~During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes."
11296103|NCT02987621|EG001|Reported Event|All Study Participants-Leg Muscle Strength Sham|"Knee extensor strength was tested for all study participants with sham stimulation (0V). All study participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.~For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds and extended until task failure or a maximum length of 20 minutes."
11296104|NCT02987621|EG002|Reported Event|All Study Participants-Leg Muscle Endurance tDCS|"Knee extensor endurance (fatigue) was tested for all participants with tDCS (less than 10V) as reported as time to failure.~During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes."
11296105|NCT02987621|EG003|Reported Event|All Study Participants-Leg Muscle Endurance Sham|"Knee extensor endurance (fatigue) was tested for all participants with sham stimulation (0V) as reported as time to failure.~The current was ramped up to 2 mA, but turned off after 30 seconds until task failure or a maximum length of 20 minutes."
11296106|NCT02987660|BG000|Baseline|LASIK|Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
11296107|NCT02987660|BG001|Baseline|SMILE|Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
11296108|NCT02987660|BG002|Baseline|Total|Total of all reporting groups
11296109|NCT02987660|FG000|Participant Flow|LASIK|Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
11296110|NCT02987660|FG001|Participant Flow|SMILE|Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
11296111|NCT02987660|OG000|Outcome|LASIK|Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
11296112|NCT02987660|OG001|Outcome|SMILE|Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
11296113|NCT02987660|EG000|Reported Event|LASIK|Subjects exposed to topography guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
11296114|NCT02987660|EG001|Reported Event|SMILE|Subjects exposed to SMILE with VisuMax laser in bilateral surgery
11296115|NCT02987829|BG000|Baseline|40 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296116|NCT02987829|BG001|Baseline|80 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296117|NCT02987829|BG002|Baseline|160 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296118|NCT02987829|BG003|Baseline|240 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296119|NCT02987829|BG004|Baseline|280 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296120|NCT02987829|BG005|Baseline|320 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296121|NCT02987829|BG006|Baseline|Total|Total of all reporting groups
11296122|NCT02987829|FG000|Participant Flow|40 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296123|NCT02987829|FG001|Participant Flow|80 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296124|NCT02987829|FG002|Participant Flow|160 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296125|NCT02987829|FG003|Participant Flow|240 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296126|NCT02987829|FG004|Participant Flow|280 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296127|NCT02987829|FG005|Participant Flow|320 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296128|NCT02987829|OG000|Outcome|40 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296129|NCT02987829|OG001|Outcome|80 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296130|NCT02987829|OG002|Outcome|160 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296131|NCT02987829|OG003|Outcome|240 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296132|NCT02987829|OG004|Outcome|280 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296133|NCT02987829|OG005|Outcome|320 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296134|NCT02987829|OG000|Outcome|40 mg TRC253/Daily Dose Levels Combined|Single-agent TRC253 to be administered as oral capsules once daily.
11296135|NCT02987829|OG001|Outcome|80 mg TRC253/Daily Dose Levels Combined|Single-agent TRC253 to be administered as oral capsules once daily.
11296136|NCT02987829|OG002|Outcome|160 mg TRC253/Daily Dose Levels Combined|Single-agent TRC253 to be administered as oral capsules once daily.
11296137|NCT02987829|EG000|Reported Event|40 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296138|NCT02987829|EG001|Reported Event|80 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296139|NCT02987829|EG002|Reported Event|160 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296140|NCT02987829|EG003|Reported Event|240 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296141|NCT02987829|EG004|Reported Event|280 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296142|NCT02987829|EG005|Reported Event|320 mg TRC253/Daily|Single-agent TRC253 to be administered as oral capsules once daily.
11296143|NCT02987868|BG000|Baseline|All Study Participants|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
11296144|NCT02987868|FG000|Participant Flow|Amino Acid Supplement First, Then Placebo|"An orally administered amino acid supplement first, and after washout period, placebo.~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative~Amino acid supplement: Supplements with the proprietary amino acid derivative blend."
11296145|NCT02987868|FG001|Participant Flow|Placebo First, Then Amino Acid Supplement|"Non-active Placebo first, and after washout period, an orally administered amino acid supplement.~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative~Amino acid supplement: Supplements with the proprietary amino acid derivative blend."
11296146|NCT02987868|OG000|Outcome|Amino Acid Supplement|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
11296147|NCT02987868|OG001|Outcome|Placebo|"Non-active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
11296148|NCT02987868|EG000|Reported Event|Amino Acid Supplement|"Supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
11296149|NCT02987868|EG001|Reported Event|Placebo|"Non-active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
11296150|NCT02987972|BG000|Baseline|V114 Lot 1|Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296151|NCT02987972|BG001|Baseline|V114 Lot 2|Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296152|NCT02987972|BG002|Baseline|Prevnar 13™|Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296153|NCT02987972|BG003|Baseline|Total|Total of all reporting groups
11296154|NCT02987972|FG000|Participant Flow|V114 Lot 1|Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296155|NCT02987972|FG001|Participant Flow|V114 Lot 2|Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296156|NCT02987972|FG002|Participant Flow|Prevnar 13™|Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296157|NCT02987972|OG000|Outcome|V114 Lot 1|Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296158|NCT02987972|OG001|Outcome|V114 Lot 2|Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296159|NCT02987972|OG002|Outcome|Prevnar 13™|Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296160|NCT02987972|EG000|Reported Event|V114 Lot 1|Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296161|NCT02987972|EG001|Reported Event|V114 Lot 2|Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296162|NCT02987972|EG002|Reported Event|Prevnar 13™|Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
11296163|NCT02988050|BG000|Baseline|Propofol-dexmedetomidine|"Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)~Dexmedetomidine: Dexmedetomidine used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296164|NCT02988050|BG001|Baseline|Propofol-remifentanil|"Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)~Remifentanil: Remifentanil used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296165|NCT02988050|BG002|Baseline|Total|Total of all reporting groups
11296166|NCT02988050|FG000|Participant Flow|Propofol-dexmedetomidine|"Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)~Dexmedetomidine: Dexmedetomidine used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296167|NCT02988050|FG001|Participant Flow|Propofol-remifentanil|"Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)~Remifentanil: Remifentanil used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296168|NCT02988050|OG000|Outcome|Conscious sedation1|"Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)~Dexmedetomidine: Dexmedetomidine used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296169|NCT02988050|OG001|Outcome|Conscious sedation2|"propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)~Remifentanil: Remifentanil used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296170|NCT02988050|EG000|Reported Event|Propofol-dexmedetomidine|"Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)~Dexmedetomidine: Dexmedetomidine used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296171|NCT02988050|EG001|Reported Event|Propofol-remifentanil|"Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)~Remifentanil: Remifentanil used for conscious sedation.~Propofol: Used for conscious sedation.~Bupivacaine: Local anaesthetics~Lidocaine: Local anaesthetic~Epinephrine: With local anaesthetic for skin infiltration."
11296172|NCT02988115|BG000|Baseline|Bempedoic Acid|Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.
11296173|NCT02988115|BG001|Baseline|Placebo|Participants received matching oral placebo once a day.
11296174|NCT02988115|BG002|Baseline|Total|Total of all reporting groups
11296175|NCT02988115|FG000|Participant Flow|Bempedoic Acid|Participants received a bempedoic acid 180 milligram (mg) tablet taken orally once a day.
11296176|NCT02988115|FG001|Participant Flow|Placebo|Participants received matching oral placebo once a day.
11296177|NCT02988115|OG000|Outcome|Bempedoic Acid|Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.
11296178|NCT02988115|OG001|Outcome|Placebo|Participants received matching oral placebo once a day.
11296179|NCT02988115|EG000|Reported Event|Bempedoic Acid|Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.
11296180|NCT02988115|EG001|Reported Event|Placebo|Participants received matching oral placebo once a day.
11296181|NCT02988193|BG000|Baseline|optima4BP Medication Management|"optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:~curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;~medication treatment recommendation;~active link to access additional analysis tools.~optima4BP Medication Management: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician."
11296182|NCT02988193|BG001|Baseline|Usual Care Medication Management|Usual Care Medication Management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
11296183|NCT02988193|BG002|Baseline|Total|Total of all reporting groups
11296184|NCT02988193|FG000|Participant Flow|optima4BP Medication Optimization|"optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:~curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;~medication treatment recommendation;~active link to access additional analysis tools.~optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician."
11296185|NCT02988193|FG001|Participant Flow|Usual Care Management|Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
10971263|NCT00914927|OG001|Outcome|Cohort A: 40 mg Avatrombopag , 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971264|NCT00914927|OG002|Outcome|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971265|NCT00914927|OG003|Outcome|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971266|NCT00914927|OG004|Outcome|Cohort B:10 mg Avatrombopag, 2G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971267|NCT00914927|OG005|Outcome|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
10971268|NCT00914927|OG006|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
11296186|NCT02988193|OG000|Outcome|optima4BP Treatment Management|"optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:~curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;~medication treatment recommendation;~active link to access additional analysis tools.~optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician."
11296187|NCT02988193|OG001|Outcome|Usual Care Treatment Management|Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
11332622|NCT03497845|EG011|Reported Event|l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant|"Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).~gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose~MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose"
10971269|NCT00914927|OG000|Outcome|Cohort A: 20 mg Aavatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971270|NCT00914927|OG001|Outcome|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971271|NCT00914927|OG004|Outcome|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
10971272|NCT00914927|OG005|Outcome|Cohort B: 20 mg Aavatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
10971273|NCT00914927|OG001|Outcome|Cohort A:40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971274|NCT00914927|OG000|Outcome|Cohort A: 20 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971275|NCT00914927|OG001|Outcome|Cohort A: 40 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971276|NCT00914927|OG002|Outcome|Cohort A: 80 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971277|NCT00914927|OG003|Outcome|Cohort A: Placebo, IG Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971278|NCT00914927|EG000|Reported Event|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971279|NCT00914927|EG001|Reported Event|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971280|NCT00914927|EG002|Reported Event|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
10971281|NCT00914927|EG003|Reported Event|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
10971282|NCT00914927|EG004|Reported Event|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
10971283|NCT00914927|EG005|Reported Event|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
11332623|NCT03498196|BG000|Baseline|Avelumab|"Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.~Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days."
11332624|NCT03498196|FG000|Participant Flow|Avelumab|"Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.~Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days."
11296188|NCT02988193|EG000|Reported Event|optima4BP Treatment Management|"optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:~curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;~medication treatment recommendation;~active link to access additional analysis tools.~optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician."
11296189|NCT02988193|EG001|Reported Event|Usual Care Treatment Management|Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
11296190|NCT02988219|BG000|Baseline|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296191|NCT02988219|BG001|Baseline|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296192|NCT02988219|BG002|Baseline|Total|Total of all reporting groups
11296193|NCT02988219|FG000|Participant Flow|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296194|NCT02988219|FG001|Participant Flow|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296195|NCT02988219|OG000|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296196|NCT02988219|OG001|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
11296197|NCT02988219|EG000|Reported Event|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296198|NCT02988219|EG001|Reported Event|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
11296199|NCT02988349|BG000|Baseline|Caries-free Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296200|NCT02988349|BG001|Baseline|Caries-active Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296201|NCT02988349|BG002|Baseline|Total|Total of all reporting groups
11296202|NCT02988349|FG000|Participant Flow|Caries-free Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296203|NCT02988349|FG001|Participant Flow|Caries-active Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296204|NCT02988349|OG000|Outcome|Caries-free Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296205|NCT02988349|OG001|Outcome|Caries-active Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296206|NCT02988349|EG000|Reported Event|Caries-free Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296207|NCT02988349|EG001|Reported Event|Caries-active Subjects|"Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.~Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks."
11296208|NCT02988622|BG000|Baseline|Scar is Treated With Fraxel Laser and CO2 Laser|"Fraxel Laser: One half of the scar is treated with Fraxel Laser~CO2 Laser: One half of the scar is treated with CO2 Laser."
11296209|NCT02988622|FG000|Participant Flow|Scar is Treated With Fraxel Laser and CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser~CO2 Laser: One half of the scar is treated with CO2 Laser."
11296210|NCT02988622|OG000|Outcome|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
11296211|NCT02988622|OG001|Outcome|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
11296212|NCT02988622|EG000|Reported Event|Scar is Treated With Fraxel Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with Fraxel Laser"
11296213|NCT02988622|EG001|Reported Event|Scar Treated With CO2 Laser|"Each patient received treatment with both lasers to separate halves of their scar.~Fraxel Laser: One half of the scar is treated with CO2 Laser"
11296214|NCT02988843|BG000|Baseline|Brentuximab Vedotin & Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
11296215|NCT02988843|FG000|Participant Flow|Brentuximab Vedotin & Bevacizumab|"Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.~Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.~Brentuximab Vedotin: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)~Bevacizumab: 15 mg/kg every 21 days"
11296216|NCT02988843|OG000|Outcome|Brentuximab Vedotin & Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
11296217|NCT02988843|EG000|Reported Event|Brentuximab Vedotin & Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
11296218|NCT02988856|BG000|Baseline|Magnetic Lid System|"All participants will trial a commercially available device and an experimental magnetic device.~Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing."
11296219|NCT02988856|FG000|Participant Flow|Magnetic Lid System|Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
11296220|NCT02988856|OG000|Outcome|Magnetic Lid System|"All participants will trial a commercially available device and an experimental magnetic device.~Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing."
11296221|NCT02988856|EG000|Reported Event|Magnetic Lid System|"All participants will trial a commercially available device and an experimental magnetic device.~Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing."
11296222|NCT02988882|BG000|Baseline|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11296223|NCT02988882|BG001|Baseline|Placebo Vehicle|PV (placebo drug delivery vehicle)
11296224|NCT02988882|BG002|Baseline|Total|Total of all reporting groups
11296225|NCT02988882|FG000|Participant Flow|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11296226|NCT02988882|FG001|Participant Flow|Placebo Vehicle|PV (placebo drug delivery vehicle)
11296227|NCT02988882|OG000|Outcome|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11296228|NCT02988882|OG001|Outcome|Placebo Vehicle|PV (placebo drug delivery vehicle)
11296229|NCT02988882|EG000|Reported Event|OTX-DP|OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
11296230|NCT02988882|EG001|Reported Event|Placebo Vehicle|PV (placebo drug delivery vehicle)
11296231|NCT02988986|BG000|Baseline|TAK-228 Plus Tamoxifen|"TAK-228 will be orally administered at 30 mg weekly for 16 weeks.~Tamoxifen will be orally administered at 20 mg daily for 16 weeks.~TAK-228: MTORC1/2 inhibitor~Tamoxifen: Non-steroidal anti-estrogen"
11296232|NCT02988986|FG000|Participant Flow|TAK-228 Plus Tamoxifen|"TAK-228 will be orally administered at 30 mg weekly for 16 weeks.~Tamoxifen will be orally administered at 20 mg daily for 16 weeks.~TAK-228: MTORC1/2 inhibitor~Tamoxifen: Non-steroidal anti-estrogen"
11296233|NCT02988986|OG000|Outcome|TAK-228 Plus Tamoxifen|"TAK-228 will be orally administered at 30 mg weekly for 16 weeks.~Tamoxifen will be orally administered at 20 mg daily for 16 weeks.~TAK-228: MTORC1/2 inhibitor~Tamoxifen: Non-steroidal anti-estrogen"
11296234|NCT02988986|OG000|Outcome|Tamoxifen|20 mg p.o QW x16 weeks
11296235|NCT02988986|EG000|Reported Event|TAK-228 and Tamoxifen|20 mg p.o QW x16 weeks
11296236|NCT02989168|BG000|Baseline|GBT440 900 mg Dose|"Part A, 900 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296237|NCT02989168|BG001|Baseline|GBT440 1500 mg Dose|"Part B, 1500 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296238|NCT02989168|BG002|Baseline|Total|Total of all reporting groups
11296239|NCT02989168|FG000|Participant Flow|GBT440 900 mg Dose|"Part A , 900 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296240|NCT02989168|FG001|Participant Flow|GBT440 1500 mg Dose|"Part B , 1500 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296241|NCT02989168|OG000|Outcome|GBT440 900 mg Dose|"Part A~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296242|NCT02989168|OG001|Outcome|GBT440 1500 mg Dose|"Part B~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296243|NCT02989168|OG000|Outcome|GBT440 900 mg Dose|"Part A , 900 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296244|NCT02989168|OG001|Outcome|GBT440 1500 mg Dose|"Part B , 1500 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296245|NCT02989168|EG000|Reported Event|GBT440 900 mg Dose|"Part A , 900 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296246|NCT02989168|EG001|Reported Event|GBT440 1500 mg Dose|"Part B , 1500 mg daily dose~GBT440: Capsules which contain GBT440 drug substance in Swedish orange"
11296247|NCT02989246|BG000|Baseline|Intervention Arm|"Ventilator management using the proposed protocol in both acute and weaning phases. Patients will be managed according the the Ventilator protocol using the esophageal catheter for the weaning phase~Ventilator protocol: Open loop ventilator management by a computer based protocol~Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations"
11296248|NCT02989246|FG000|Participant Flow|Intervention Arm|"Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter~Ventilator protocol: Open loop ventilator management by a computer based protocol~Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations"
11296249|NCT02989246|OG000|Outcome|Intervention Arm|"Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter~Ventilator protocol: Open loop ventilator management by a computer based protocol~Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations"
11296250|NCT02989246|EG000|Reported Event|Intervention Arm|"Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter~Ventilator protocol: Open loop ventilator management by a computer based protocol~Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations"
11296251|NCT02989389|BG000|Baseline|Part A-Cohort 1 (Sequence 1)|Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795.
11296252|NCT02989389|BG001|Baseline|Part A-Cohort 1 (Sequence 2)|Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795.
11296253|NCT02989389|BG002|Baseline|Part A-Cohort 1 (Sequence 3)|Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo.
11296254|NCT02989389|BG003|Baseline|Part A-Cohort 2 (Sequence 1)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo.
11296255|NCT02989389|BG004|Baseline|Part A-Cohort 2 (Sequence 2)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795.
11296256|NCT02989389|BG005|Baseline|Part A-Cohort 2 (Sequence 3)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795.
11296257|NCT02989389|BG006|Baseline|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296258|NCT02989389|BG007|Baseline|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
11296259|NCT02989389|BG008|Baseline|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296260|NCT02989389|BG009|Baseline|Part B, Placebo|Participants received placebo identical to LY3323795 orally.
11296261|NCT02989389|BG010|Baseline|Total|Total of all reporting groups
11296262|NCT02989389|FG000|Participant Flow|Part A-Cohort 1 (Sequence 1)|Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795
11296263|NCT02989389|FG001|Participant Flow|Part A-Cohort 1 (Sequence 2)|Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795
11296264|NCT02989389|FG002|Participant Flow|Part A-Cohort 1 (Sequence 3)|Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo
11296265|NCT02989389|FG003|Participant Flow|Part A-Cohort 2 (Sequence 1)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo
11296266|NCT02989389|FG004|Participant Flow|Part A-Cohort 2 (Sequence 2)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795
11296267|NCT02989389|FG005|Participant Flow|Part A-Cohort 2 (Sequence 3)|Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795
11296268|NCT02989389|FG006|Participant Flow|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296269|NCT02989389|FG007|Participant Flow|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
10971284|NCT00914927|EG006|Reported Event|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
11296270|NCT02989389|FG008|Participant Flow|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296271|NCT02989389|FG009|Participant Flow|Part B, Placebo|Participants received placebo identical to LY3323795 orally.
11296272|NCT02989389|OG000|Outcome|Part A, Cohort 1, Placebo|Participants received placebo identical to LY3323795 orally.
11296273|NCT02989389|OG001|Outcome|Part A, Cohort 1, 0.3 mg LY3323795|Participants received 0.3 mg of LY3323795 orally.
11296274|NCT02989389|OG002|Outcome|Part A, Cohort 1, 3 mg LY3323795|Participants received 3 mg of LY3323795 orally.
11296275|NCT02989389|OG003|Outcome|Part A, Cohort 1, 30 mg LY3323795|Participants received 30 mg of LY3323795 orally.
11296276|NCT02989389|OG004|Outcome|Part A, Cohort 2, Placebo|Participants received placebo identical to LY3323795 orally.
11296277|NCT02989389|OG005|Outcome|Part A, Cohort 2, 1 mg LY3323795|Participants received 1 mg of LY3323795 orally.
11296278|NCT02989389|OG006|Outcome|Part A, Cohort 2, 10 mg LY3323795|Participants received 10 mg of LY3323795 orally.
11296279|NCT02989389|OG007|Outcome|Part A, Cohort 2, 100 mg LY3323795|Participants received 100 mg of LY3323795 orally.
11296280|NCT02989389|OG008|Outcome|Part B, Placebo|Participants received placebo identical to LY3323795 orally.
11296281|NCT02989389|OG009|Outcome|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296282|NCT02989389|OG010|Outcome|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
11296283|NCT02989389|OG011|Outcome|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296284|NCT02989389|OG000|Outcome|Part A, Cohort 1, 0.3 mg LY3323795|Participants received 0.3 mg of LY3323795 orally.
11296285|NCT02989389|OG001|Outcome|Part A, Cohort 2, 1 mg LY3323795|Participants received 1 mg of LY3323795 orally.
11296286|NCT02989389|OG003|Outcome|Part A, Cohort 2, 10 mg LY3323795|Participants received 10 mg of LY3323795 orally.
11296287|NCT02989389|OG004|Outcome|Part A, Cohort 1, 30 mg LY3323795|Participants received 30 mg of LY3323795 orally.
11296288|NCT02989389|OG005|Outcome|Part A, Cohort 2, 100 mg LY3323795|Participants received 100 mg of LY3323795 orally.
11296289|NCT02989389|OG006|Outcome|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296290|NCT02989389|OG007|Outcome|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
11296291|NCT02989389|OG008|Outcome|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296292|NCT02989389|OG000|Outcome|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296293|NCT02989389|OG001|Outcome|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
11296294|NCT02989389|OG002|Outcome|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296295|NCT02989389|OG004|Outcome|Part A, Cohort 1, 30 mg LY3323795|Participants received 10 mg of LY3323795 orally.
11296296|NCT02989389|OG009|Outcome|Placebo|Participants received placebo identical to LY3323795 orally.
11296297|NCT02989389|OG003|Outcome|Placebo|Participants received placebo identical to LY3323795 orally.
11296298|NCT02989389|EG000|Reported Event|Part A, Cohort 1, Placebo|Participants received placebo identical to LY3323795 orally.
11296299|NCT02989389|EG001|Reported Event|Part A, Cohort 1, 0.3 mg LY3323795|Participants received 0.3 mg of LY3323795 orally.
11296300|NCT02989389|EG002|Reported Event|Part A, Cohort 1, 3 mg LY3323795|Participants received 3 mg of LY3323795 orally.
11296301|NCT02989389|EG003|Reported Event|Part A, Cohort 1, 30 mg LY3323795|Participants received 30 mg of LY3323795 orally.
11296302|NCT02989389|EG004|Reported Event|Part A, Cohort 2, Placebo|Participants received placebo identical to LY3323795 orally.
11296303|NCT02989389|EG005|Reported Event|Part A, Cohort 2, 1 mg LY3323795|Participants received 1 mg of LY3323795 orally.
11296304|NCT02989389|EG006|Reported Event|Part A, Cohort 2, 10 mg LY3323795|Participants received 10 mg of LY3323795 orally.
11296305|NCT02989389|EG007|Reported Event|Part A, Cohort 2, 100 mg LY3323795|Participants received 100 mg of LY3323795 orally.
11296306|NCT02989389|EG008|Reported Event|Part B, 6 mg LY3323795|Participants received 6 mg of LY3323795 orally.
11296307|NCT02989389|EG009|Reported Event|Part B, 20 mg LY3323795|Participants received 20 mg of LY3323795 orally.
11296308|NCT02989389|EG010|Reported Event|Part B, 80 mg LY3323795|Participants received 80 mg of LY3323795 orally.
11296309|NCT02989389|EG011|Reported Event|Part B, Placebo|Participants received placebo identical to LY3323795 orally.
11296310|NCT02989493|BG000|Baseline|Doxazosin|"Participants receive 8 weeks of doxazosin (8mg target dose).~Doxazosin: Doxazosin"
11296311|NCT02989493|BG001|Baseline|Placebo|"Participants will receive 8 weeks of matched placebo.~Placebo: Placebo"
11296312|NCT02989493|BG002|Baseline|Total|Total of all reporting groups
11296313|NCT02989493|FG000|Participant Flow|Doxazosin|"Participants receive 8 weeks of doxazosin (8mg target dose).~Doxazosin: Doxazosin"
11296314|NCT02989493|FG001|Participant Flow|Placebo|"Participants will receive 8 weeks of matched placebo.~Placebo: Placebo"
11296315|NCT02989493|OG000|Outcome|Doxazosin|"Participants receive 8 weeks of doxazosin (8mg target dose).~Doxazosin: Doxazosin"
11296316|NCT02989493|OG001|Outcome|Placebo|"Participants will receive 8 weeks of matched placebo.~Placebo: Placebo"
11296317|NCT02989493|EG000|Reported Event|Doxazosin|"Participants receive 8 weeks of doxazosin (8mg target dose).~Doxazosin: Doxazosin"
11296318|NCT02989493|EG001|Reported Event|Placebo|"Participants will receive 8 weeks of matched placebo.~Placebo: Placebo"
11296319|NCT02989545|BG000|Baseline|All Patients|2 week period without intervention then 2 week period with anal tape intervention
11296320|NCT02989545|FG000|Participant Flow|Per Sequence|Off treatment first for 14 days Treatment period second for 14 days
11296321|NCT02989545|OG000|Outcome|Off Treatment|2 week period without intervention
11296322|NCT02989545|OG001|Outcome|Treatment Period|2 week period with intervention - Anal tape
11296323|NCT02989545|OG001|Outcome|Treatment Period|"2 week period with intervention~Anal Tape"
11296324|NCT02989545|OG000|Outcome|Treatment Period|"2 week period with intervention~Anal Tape"
11296325|NCT02989545|EG000|Reported Event|Control Period - No Intervention|Consiting of the first 14 days of the study during which patients were off treatment and baseline and safety data was collected
11296326|NCT02989545|EG001|Reported Event|Treatment Period - Anal Tape Provided|"Consiting of the second 14 days of the study (day 15 to 28) during which patients were provided with the anal tape device and during this period efficacy and safety data was collected."
11296327|NCT02989610|BG000|Baseline|Omnidirectional Followed by Directional DBS|"Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.~At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead."
11296328|NCT02989610|FG000|Participant Flow|Omnidirectional Followed by Directional DBS|Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
11296329|NCT02989610|OG000|Outcome|Omnidirectional Followed by Directional DBS|Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
11296330|NCT02989610|EG000|Reported Event|Omnidirectional Followed by Directional DBS|"Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.~At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead."
11296331|NCT02989649|BG000|Baseline|Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)|Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
11296332|NCT02989649|FG000|Participant Flow|Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)|Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
11296333|NCT02989649|OG000|Outcome|Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)|Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
11296334|NCT02989649|EG000|Reported Event|Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)|Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
11296335|NCT02989714|BG000|Baseline|HD IL2 and Nivolumab|"Interleukin-2: 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart~Nivolumab: Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression"
11296336|NCT02989714|FG000|Participant Flow|HD IL2 and Nivolumab|"Interleukin-2: 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart~Nivolumab: Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression"
11296337|NCT02989714|OG000|Outcome|HD IL2 and Nivolumab|"Interleukin-2: 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart~Nivolumab: Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression"
11296338|NCT02989714|OG000|Outcome|HD IL2 and Nivolumab|"Interleukin-2: 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart.~Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression."
11296339|NCT02989714|EG000|Reported Event|HD IL2 and Nivolumab|"Interleukin-2: 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart~Nivolumab: Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression"
11296340|NCT02989727|BG000|Baseline|Lamotrigine - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296341|NCT02989727|BG001|Baseline|Placebo - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296342|NCT02989727|BG002|Baseline|Lamotrigine - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296343|NCT02989727|BG003|Baseline|Placebo - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296344|NCT02989727|BG004|Baseline|Total|Total of all reporting groups
11296345|NCT02989727|FG000|Participant Flow|Lamotrigine - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296346|NCT02989727|FG001|Participant Flow|Placebo - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296347|NCT02989727|FG002|Participant Flow|Lamotrigine - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296348|NCT02989727|FG003|Participant Flow|Placebo - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296349|NCT02989727|OG000|Outcome|Lamotrigine - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296350|NCT02989727|OG001|Outcome|Placebo - Melancholic Depression|"Participants with melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296351|NCT02989727|OG002|Outcome|Lamotrigine - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.~Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8."
11296352|NCT02989727|OG003|Outcome|Placebo - Nonmelancholic Depression|"Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.~Placebos: Placebo tablets"
11296353|NCT02989727|EG000|Reported Event|Lamotrigine|The data is from 109 participant that were randomized in the original trial.
11296354|NCT02989727|EG001|Reported Event|Placebo|The data is from 109 participant that were randomized in the original trial.
11296355|NCT02989805|BG000|Baseline|Professional Care Manager|Participants meeting with a nurse or social worker to provide care management
11296356|NCT02989805|BG001|Baseline|Peer Specialist Care Manager|Participants meeting with a peer specialist to provide care management
11296357|NCT02989805|BG002|Baseline|Total|Total of all reporting groups
11296358|NCT02989805|FG000|Participant Flow|Professional Care Manager|Participants meeting with a nurse or social worker to provide care management
11296359|NCT02989805|FG001|Participant Flow|Peer Specialist Care Manager|Participants meeting with a peer specialist to provide care management
11296360|NCT02989805|OG000|Outcome|Professional Care Manager|Participants meeting with a nurse or social worker to provide care management
11296361|NCT02989805|OG001|Outcome|Peer Specialist Care Manager|Participants meeting with a peer specialist to provide care management
11296362|NCT02989805|EG000|Reported Event|Professional Care Manager|Participants meeting with a nurse or social worker to provide care management
11296363|NCT02989805|EG001|Reported Event|Peer Specialist Care Manager|Participants meeting with a peer specialist to provide care management
11296364|NCT02990000|BG000|Baseline|Pragmatic Match|Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
11296365|NCT02990000|BG001|Baseline|Scientific Match|"Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)~Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety)."
11296366|NCT02990000|BG002|Baseline|Total|Total of all reporting groups
11296367|NCT02990000|FG000|Participant Flow|Pragmatic Match|Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
11296368|NCT02990000|FG001|Participant Flow|Scientific Match|"Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)~Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety)."
11296369|NCT02990000|OG000|Outcome|Pragmatic Match|Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
11296370|NCT02990000|OG001|Outcome|Scientific Match|"Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)~Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety)."
11296371|NCT02990000|EG000|Reported Event|Pragmatic Match|Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
11296372|NCT02990000|EG001|Reported Event|Scientific Match|"Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)~Scientific Match: We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety)."
11296373|NCT02990910|BG000|Baseline|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
11296374|NCT02990910|BG001|Baseline|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
11296375|NCT02990910|BG002|Baseline|Total|Total of all reporting groups
11296376|NCT02990910|FG000|Participant Flow|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
11296377|NCT02990910|FG001|Participant Flow|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
11296378|NCT02990910|OG000|Outcome|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
11296379|NCT02990910|OG001|Outcome|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
11296380|NCT02990910|EG000|Reported Event|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
11296381|NCT02990910|EG001|Reported Event|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.~conventional opioid analgesia: (b) all received 25μg/kg morphine"
11296382|NCT02991040|BG000|Baseline|Revanesse Ultra+|"Revanesse Ultra+ (with lidocaine)~Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)~Revanesse Ultra: Comparator without lidocaine"
11296383|NCT02991040|FG000|Participant Flow|Revanesse Ultra+|"Revanesse Ultra+ (with lidocaine)~Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)~Revanesse Ultra: Comparator without lidocaine"
11296384|NCT02991040|OG000|Outcome|Revanesse Ultra+|"Revanesse Ultra+ (with lidocaine)~Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)~Revanesse Ultra: Comparator without lidocaine"
11296385|NCT02991040|OG001|Outcome|Revanesse Ultra|Revanesse Ultra (without lidocaine)
11296386|NCT02991040|EG000|Reported Event|Revanesse Ultra+|"Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine~Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)~Revanesse Ultra: Comparator without lidocaine"
11296387|NCT02991040|EG001|Reported Event|Revanesse Ultra|Revanesse Ultra (without lidocaine)
11296388|NCT02991118|BG000|Baseline|Placebo|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296389|NCT02991118|BG001|Baseline|Bempedoic Acid|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296390|NCT02991118|BG002|Baseline|Total|Total of all reporting groups
11296391|NCT02991118|FG000|Participant Flow|Placebo|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296392|NCT02991118|FG001|Participant Flow|Bempedoic Acid|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296393|NCT02991118|OG000|Outcome|Placebo|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296394|NCT02991118|OG001|Outcome|Bempedoic Acid|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296395|NCT02991118|EG000|Reported Event|Placebo|Participants received placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11296396|NCT02991118|EG001|Reported Event|Bempedoic Acid|Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
11332625|NCT03498196|OG000|Outcome|Avelumab|"Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.~Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days."
11332626|NCT03498196|EG000|Reported Event|Avelumab|"Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.~Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days."
11332627|NCT03498287|BG000|Baseline|Study Device|"Small, non-invasive, orthodontic arch with adhesive applied to the wrist~Study Device: Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks)."
11296397|NCT02991729|BG000|Baseline|Routine Care|"These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.~Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues."
11296398|NCT02991729|BG001|Baseline|Experimental|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11296399|NCT02991729|BG002|Baseline|Total|Total of all reporting groups
11296400|NCT02991729|FG000|Participant Flow|Routine Care|"These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.~Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues."
11296401|NCT02991729|FG001|Participant Flow|Experimental|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11296402|NCT02991729|OG000|Outcome|Routine Care|"These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.~Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues."
11296403|NCT02991729|OG001|Outcome|Experimental|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11296404|NCT02991729|OG000|Outcome|Experimental: Pre-genetic Counseling|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11332628|NCT03498287|BG001|Baseline|Sham Device|"Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.~Sham Device: Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase."
11332629|NCT03498287|BG002|Baseline|Total|Total of all reporting groups
11332630|NCT03498287|FG000|Participant Flow|Study Device|"Small, non-invasive, orthodontic arch with adhesive applied to the wrist~Study Device: Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). (1 wrist per participant)"
11296405|NCT02991729|OG001|Outcome|Experimental: Post-genetic Counseling|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11296406|NCT02991729|EG000|Reported Event|Routine Care|"These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.~Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues."
11296407|NCT02991729|EG001|Reported Event|Experimental|"These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.~iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.~Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment"
11296408|NCT02991820|BG000|Baseline|Inexperienced Users|"Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296409|NCT02991820|BG001|Baseline|Experienced Users|"Experienced users will include faculty pediatric anesthesiologists CRNAs.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296410|NCT02991820|BG002|Baseline|Total|Total of all reporting groups
11296411|NCT02991820|FG000|Participant Flow|Inexperienced Users|"Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296412|NCT02991820|FG001|Participant Flow|Experienced Users|"Experienced users will include faculty pediatric anesthesiologists CRNAs.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296413|NCT02991820|OG000|Outcome|Inexperienced Users|"Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296414|NCT02991820|OG001|Outcome|Experienced Users|"Experienced users will include faculty pediatric anesthesiologists CRNAs.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296415|NCT02991820|OG000|Outcome|Inexperienced Users|"Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.~Miller: Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope~Macintosh: Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope~C-MAC: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope~GlideScope: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope"
10848280|NCT00289315|FG000|Participant Flow|Arm 1-Primary Prevention of Weight Gain|"Primary Prevention of weight gain~Primary weight gain prevention: School-based program that modifies the school environment to promote healthy eating and physical activity~Primary Prevention: School-based environmental program to promote healthy eating and physical activity."
10848281|NCT00289315|FG001|Participant Flow|Arm 2-Primary and Secondary Weight Gain Prevention Program|"Primary and secondary weight gain prevention program~Primary and Secondary Prevention: School-based program that combines an environmental weight gain prevention program with a curriculum/internet-based program to promote weight loss in overweight students"
10848282|NCT00289315|FG002|Participant Flow|Arm 3-Control|"Control~Control: Control program that does not include an active intervention for promoting healthy eating and physical activity."
11296416|NCT02991820|OG001|Outcome|Experienced Users|"Experienced users will include faculty pediatric anesthesiologists CRNAs.~Miller: Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope~Macintosh: Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope~C-MAC: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope~GlideScope: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope"
11296417|NCT02991820|EG000|Reported Event|Inexperienced Users|"Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296418|NCT02991820|EG001|Reported Event|Experienced Users|"Experienced users will include faculty pediatric anesthesiologists CRNAs.~Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL)."
11296419|NCT02991859|BG000|Baseline|Arm AB - FF Followed by FP|Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296420|NCT02991859|BG001|Baseline|AC - FF Followed by BUD|Participants will receive PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants will receive PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period will be of 25-42 days
11296421|NCT02991859|BG002|Baseline|Arm AD - FF Followed by ELLIPTA Placebo|Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
11296422|NCT02991859|BG003|Baseline|Arm BA - FP Followed by FF|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296423|NCT02991859|BG004|Baseline|Arm BC - FP Followed by BUD|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
11296424|NCT02991859|BG005|Baseline|Arm BE - FP Followed by DISKUS Placebo|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
10848283|NCT00289315|OG000|Outcome|Arm 1|"Primary Prevention of weight gain~Primary weight gain prevention: School-based program that modifies the school environment to promote healthy eating and physical activity~Primary Prevention: School-based environmental program to promote healthy eating and physical activity."
10848284|NCT00289315|OG001|Outcome|Arm 2|"Primary and secondary weight gain prevention program~Primary and Secondary Prevention: School-based program that combines an environmental weight gain prevention program with a curriculum/internet-based program to promote weight loss in overweight students"
11332631|NCT03498287|FG001|Participant Flow|Sham Device|"Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.~Sham Device: Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). (1 wrist per participant)~*Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase."
11296425|NCT02991859|BG006|Baseline|Arm CA - BUD Followed by FF|Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296426|NCT02991859|BG007|Baseline|Arm CB - BUD Followed by FP|Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296427|NCT02991859|BG008|Baseline|Arm CE - BUD Followed by DISKUS Placebo|Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
11296428|NCT02991859|BG009|Baseline|Arm DA - ELLIPTA Placebo Followed by FF|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296429|NCT02991859|BG010|Baseline|EB - DISKUS Placebo Followed by FP|Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296430|NCT02991859|BG011|Baseline|Arm DC - ELLIPTA Placebo Followed by BUD|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
11296431|NCT02991859|BG012|Baseline|Fluticasone Furoate (FF)|Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
11296432|NCT02991859|BG013|Baseline|Fluticasone Propionate (FP)|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
11296433|NCT02991859|BG014|Baseline|Budesonide (BUD)|Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
11296434|NCT02991859|BG015|Baseline|ELLIPTA|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
11296435|NCT02991859|BG016|Baseline|DISKUS|Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
11296436|NCT02991859|BG017|Baseline|Total|Total of all reporting groups
11332632|NCT03498287|OG000|Outcome|Study Device|"Small, non-invasive, orthodontic arch with adhesive applied to the wrist~Study Device: Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks)."
10848285|NCT00289315|OG002|Outcome|Arm 3|"Control~Control: Control program that does not include an active intervention for promoting healthy eating and physical activity."
11296437|NCT02991859|FG000|Participant Flow|Arm AB - FF Followed by FP|Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296438|NCT02991859|FG001|Participant Flow|Arm AC - FF Followed by BUD|Participants received PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period was of 25-42 days.
11296439|NCT02991859|FG002|Participant Flow|Arm AD - FF Followed by ELLIPTA Placebo|Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
11296440|NCT02991859|FG003|Participant Flow|Arm BA - FP Followed by FF|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296441|NCT02991859|FG004|Participant Flow|Arm BC - FP Followed by BUD|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
11296442|NCT02991859|FG005|Participant Flow|Arm BE - FP Followed by DISKUS Placebo|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
11296443|NCT02991859|FG006|Participant Flow|Arm CA - BUD Followed by FF|Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296444|NCT02991859|FG007|Participant Flow|Arm CB - BUD Followed by FP|Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296445|NCT02991859|FG008|Participant Flow|Arm CE - BUD Followed by DISKUS Placebo|Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
11296446|NCT02991859|FG009|Participant Flow|Arm DA - ELLIPTA Placebo Followed by FF|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
11296447|NCT02991859|FG010|Participant Flow|EB - DISKUS Placebo Followed by FP|Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
11296448|NCT02991859|FG011|Participant Flow|Arm DC - ELLIPTA Placebo Followed by BUD|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
11296449|NCT02991859|FG012|Participant Flow|Fluticasone Furoate (FF)|Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
11296450|NCT02991859|FG013|Participant Flow|Fluticasone Propionate (FP)|Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
11296451|NCT02991859|FG014|Participant Flow|Budesonide (BUD)|Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
11296452|NCT02991859|FG015|Participant Flow|ELLIPTA|Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
11296453|NCT02991859|FG016|Participant Flow|DISKUS|Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
11296454|NCT02991859|OG000|Outcome|FF 25 mcg|Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
11296455|NCT02991859|OG001|Outcome|FF 100 mcg|Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
10971285|NCT00914940|BG000|Baseline|Overall Study Participants|"CONDITIONING: Patients receive TBI twice per day on days -10 to -7, then thiotepa IV administered over approximately 4 hours on days -6 and -5, and fludarabine IV administered over 30 minutes on days -6 to -2.~DONOR BONE MARROW TRANSPLANTATION: GCSF-mobilized CD34 enriched PBSC and CD45RA depleted cells infused on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Ptients receive tacrolimus beginning on day -1 by continuous IV infusion, converting to oral formulation when oral feeding is established. If there is no evidence of grade II-IV acute GVHD prior to day 50, tacrolimus is then tapered."
11296456|NCT02991859|OG002|Outcome|FF 200 mcg|Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
11296457|NCT02991859|OG003|Outcome|FF 400 mcg|Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
11296458|NCT02991859|OG004|Outcome|FF 800 mcg|Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
11296459|NCT02991859|OG005|Outcome|FP 50 mcg|Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
11296460|NCT02991859|OG006|Outcome|FP 200 mcg|Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
10971286|NCT00914940|FG000|Participant Flow|Overall Study Participants|CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
10971287|NCT00914940|OG000|Outcome|Overall Study Participants|CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
10971288|NCT00914940|EG000|Reported Event|Overall Study Participants|CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
10971289|NCT00914966|BG000|Baseline|CINRYZE|There were 3 potential dose escalation steps: - Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study) - Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks - Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
10971290|NCT00914966|FG000|Participant Flow|CINRYZE|There were 3 potential dose escalation steps: - Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study) - Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks - Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
10971291|NCT00914966|OG000|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
10971292|NCT00914966|OG001|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
10971293|NCT00914966|OG002|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
10971294|NCT00914966|EG000|Reported Event|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
10971295|NCT00914966|EG001|Reported Event|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
10971296|NCT00914966|EG002|Reported Event|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
10971297|NCT00914966|EG003|Reported Event|All Subjects|
10971298|NCT00915005|BG000|Baseline|Intensity-modulated (Photon) Radiotherapy (IMRT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971299|NCT00915005|BG001|Baseline|Passive Scattering Proton Therapy (PSPT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971300|NCT00915005|BG002|Baseline|Total|Total of all reporting groups
10971301|NCT00915005|FG000|Participant Flow|Intensity-modulated (Photon) Radiotherapy (IMRT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971302|NCT00915005|FG001|Participant Flow|Passive Scattering Proton Therapy (PSPT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971303|NCT00915005|OG000|Outcome|Intensity-modulated (Photon) Radiotherapy (IMRT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971304|NCT00915005|OG001|Outcome|Passive Scattering Proton Therapy (PSPT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971305|NCT00915005|EG000|Reported Event|Intensity-modulated (Photon) Radiotherapy (IMRT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971306|NCT00915005|EG001|Reported Event|Passive Scattering Proton Therapy (PSPT)|All patients on this trial will receive concurrent weekly carboplatin and paclitaxel chemotherapy with radiation therapy 74 or 66 Gy(RBE).
10971307|NCT00915018|BG000|Baseline|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
10971308|NCT00915018|BG001|Baseline|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
10971309|NCT00915018|BG002|Baseline|Total|Total of all reporting groups
10971310|NCT00915018|FG000|Participant Flow|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
11296461|NCT02991859|OG007|Outcome|FP 500 mcg|Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296462|NCT02991859|OG008|Outcome|FP 1000 mcg|Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296463|NCT02991859|OG009|Outcome|FP 2000 mcg|Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296464|NCT02991859|OG010|Outcome|BUD 100 mcg|Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
11296465|NCT02991859|OG011|Outcome|BUD 400 mcg|Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296466|NCT02991859|OG012|Outcome|BUD 800 mcg|Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296467|NCT02991859|OG013|Outcome|BUD 1600 mcg|Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296468|NCT02991859|OG014|Outcome|BUD 3200 mcg|Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
11296469|NCT02991859|OG000|Outcome|Fluticasone Propionate (FP)|Participants received FF ELLIPTA 25 mcg, 100 mcg, 200 mcg, 400 mcg, 800 mcg for 7 days.
11296470|NCT02991859|OG000|Outcome|Fluticasone Propionate (FP)|Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
11296471|NCT02991859|OG000|Outcome|Budesonide (BUD)|Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
11296472|NCT02991859|OG000|Outcome|Placebo|Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
11296473|NCT02991859|OG001|Outcome|FF 25 mcg|Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
11296474|NCT02991859|OG002|Outcome|FF 100 mcg|Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
11296475|NCT02991859|OG003|Outcome|FF 200 mcg|Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
11296476|NCT02991859|OG004|Outcome|FF 400 mcg|Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
11296477|NCT02991859|OG005|Outcome|FF 800 mcg|Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
11296478|NCT02991859|OG006|Outcome|FP 50 mcg|Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
11296479|NCT02991859|OG007|Outcome|FP 200 mcg|Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296480|NCT02991859|OG008|Outcome|FP 500 mcg|Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
10848286|NCT00289315|EG000|Reported Event|Arm 1|"Primary Prevention of weight gain~Primary weight gain prevention: School-based program that modifies the school environment to promote healthy eating and physical activity~Primary Prevention: School-based environmental program to promote healthy eating and physical activity."
10848287|NCT00289315|EG001|Reported Event|Arm 2|"Primary and secondary weight gain prevention program~Primary and Secondary Prevention: School-based program that combines an environmental weight gain prevention program with a curriculum/internet-based program to promote weight loss in overweight students"
11296481|NCT02991859|OG009|Outcome|FP 1000 mcg|Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296482|NCT02991859|OG010|Outcome|FP 2000 mcg|Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296483|NCT02991859|OG011|Outcome|BUD 100 mcg|Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
11296484|NCT02991859|OG012|Outcome|BUD 400 mcg|Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296485|NCT02991859|OG013|Outcome|BUD 800 mcg|Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296486|NCT02991859|OG014|Outcome|BUD 1600 mcg|Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296487|NCT02991859|OG015|Outcome|BUD 3200 mcg|Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
11296488|NCT02991859|OG000|Outcome|FF 25 mcg|Participants received FF ELLIPTA 25 mcg 1 puff PM as total daily dose for 7 days
11296489|NCT02991859|OG000|Outcome|FF 100 mcg|Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
11296490|NCT02991859|OG000|Outcome|FF 200 mcg|Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days
11296491|NCT02991859|OG000|Outcome|FF 400 mcg|Participants received FF ELLIPTA 200 mcg 2 puff PM as total daily dose for 7 days
11296492|NCT02991859|OG000|Outcome|FF 800 mcg|Participants received FF ELLIPTA 200 mcg 4 puff PM as total daily dose for 7 days
11296493|NCT02991859|OG000|Outcome|FF 400 mcg|Participants received FF ELLIPTA 400 mcg 1 puff PM as total daily dose for 7 days
11296494|NCT02991859|OG000|Outcome|FP 50 mcg|Participants received FP ELLIPTA 50 mcg 1 puff PM as total daily dose for 7 days
11296495|NCT02991859|OG000|Outcome|FP 200 mcg|Participants received FP DISKSU 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
11296496|NCT02991859|OG000|Outcome|FP 200 mcg|Participants received FP DISKSUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
11296497|NCT02991859|OG000|Outcome|FP 500 mcg|Participants received FP DISKSUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
11296498|NCT02991859|OG000|Outcome|FP 500 mcg|Participants received FP DISKUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
11296499|NCT02991859|OG000|Outcome|FP 1000 mcg|Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days
11296500|NCT02991859|OG000|Outcome|FP 1000 mcg|Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296501|NCT02991859|OG000|Outcome|FP 2000 mcg|Participants received FP DISKSU 500 mcg 2 puffs AM and 2 puffs PM as total daily dose for 7 days.
11296502|NCT02991859|OG000|Outcome|BUD 100 mcg|Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
11296503|NCT02991859|OG000|Outcome|BUD 400 mcg|Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296504|NCT02991859|OG000|Outcome|BUD 800 mcg|Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296505|NCT02991859|OG000|Outcome|BUD 1600 mcg|Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296506|NCT02991859|OG000|Outcome|BUD 3200 mcg|Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
11296507|NCT02991859|OG001|Outcome|Fluticasone Furoate (FF)|Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
11296508|NCT02991859|OG002|Outcome|Fluticasone Propionate (FP)|Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.
11296509|NCT02991859|OG003|Outcome|Budesonide.|Participants received Participants received BUD Turbuhaler 100 mcg, 400 mcg, 800 mcg, 1600 mcg, 3200 mcg as total daily dose for 7 days.
11296510|NCT02991859|OG003|Outcome|Budesonide (BUD)|Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
11296511|NCT02991859|EG000|Reported Event|Placebo|Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
11296512|NCT02991859|EG001|Reported Event|FF 25 mcg|Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
11296513|NCT02991859|EG002|Reported Event|FF 100 mcg|Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
11296514|NCT02991859|EG003|Reported Event|FF 200 mcg|Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
11296515|NCT02991859|EG004|Reported Event|FF 400 mcg|Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
11296516|NCT02991859|EG005|Reported Event|FF 800 mcg|Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
11296517|NCT02991859|EG006|Reported Event|FP 50 mcg|Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
11296518|NCT02991859|EG007|Reported Event|FP 200 mcg|Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296519|NCT02991859|EG008|Reported Event|FP 500 mcg|Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296520|NCT02991859|EG009|Reported Event|FP 1000 mcg|Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296521|NCT02991859|EG010|Reported Event|FP 2000 mcg|Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296522|NCT02991859|EG011|Reported Event|BUD 100 mcg|Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
11296523|NCT02991859|EG012|Reported Event|BUD 400 mcg|Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296524|NCT02991859|EG013|Reported Event|BUD 800 mcg|Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
11296525|NCT02991859|EG014|Reported Event|BUD 1600 mcg|Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
11296526|NCT02991859|EG015|Reported Event|BUD 3200 mcg|Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
11296527|NCT02991898|BG000|Baseline|Treg Infusion|The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
11296528|NCT02991898|FG000|Participant Flow|Treg Infusion|The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
11296529|NCT02991898|OG000|Outcome|Treg Infusion|The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
11296530|NCT02991898|EG000|Reported Event|Treg Infusion|The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
11296531|NCT02992067|BG000|Baseline|Operable Breast Cancer|clinical stage: cTis, cI, cII, cT3N1M0
11296532|NCT02992067|FG000|Participant Flow|Operable Breast Cancer|clinical stage: cTis, cI, cII, cT3N1M0
11296533|NCT02992067|OG000|Outcome|Operable Breast Cancer|clinical stage: cTis, cI, cII, cT3N1M0
11296534|NCT02992067|EG000|Reported Event|Operable Breast Cancer|clinical stage: cTis, cI, cII, cT3N1M0
11296535|NCT02992132|BG000|Baseline|Placebo|"Placebo, taken as two tablets, once daily by mouth~Placebo: Placebo, taken as two tablets, once daily by mouth"
11296536|NCT02992132|BG001|Baseline|Pimavanserin 20 mg|"Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth~Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth"
11296537|NCT02992132|BG002|Baseline|Pimavanserin 34 mg|"Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth~Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth"
11296538|NCT02992132|BG003|Baseline|Total|Total of all reporting groups
11296539|NCT02992132|FG000|Participant Flow|Placebo|"Placebo, taken as two tablets, once daily by mouth~Placebo: Placebo, taken as two tablets, once daily by mouth"
11296540|NCT02992132|FG001|Participant Flow|Pimavanserin 20 mg|"Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth~Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth"
11296541|NCT02992132|FG002|Participant Flow|Pimavanserin 34 mg|"Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth~Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth"
11296542|NCT02992132|OG000|Outcome|Placebo|"Placebo, taken as two tablets, once daily by mouth~Placebo: Placebo, taken as two tablets, once daily by mouth"
11296543|NCT02992132|OG001|Outcome|Pimavanserin 20 mg|"Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth~Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth"
11296544|NCT02992132|OG002|Outcome|Pimavanserin 34 mg|"Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth~Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth"
11296545|NCT02992132|EG000|Reported Event|Placebo|"Placebo, taken as two tablets, once daily by mouth~Placebo: Placebo, taken as two tablets, once daily by mouth"
11296546|NCT02992132|EG001|Reported Event|Pimavanserin 20 mg|"Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth~Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth"
11296547|NCT02992132|EG002|Reported Event|Pimavanserin 34 mg|"Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth~Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth"
11296548|NCT02992197|BG000|Baseline|Rotarix, Single Dose|"Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix"
11296549|NCT02992197|BG001|Baseline|Rotarix, Double Dose|"Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Rotarix, dose 2: Rotarix, dose 2"
11296550|NCT02992197|BG002|Baseline|Total|Total of all reporting groups
11296551|NCT02992197|FG000|Participant Flow|Rotarix, Single Dose|"Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix"
11296552|NCT02992197|FG001|Participant Flow|Rotarix, Double Dose|"Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Rotarix, dose 2: Rotarix, dose 2"
11296553|NCT02992197|OG000|Outcome|Rotarix, Single Dose|"Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix"
11296554|NCT02992197|OG001|Outcome|Rotarix, Double Dose|"Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Rotarix, dose 2: Rotarix, dose 2"
11296555|NCT02992197|EG000|Reported Event|Rotarix, Single Dose|"Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix"
11296556|NCT02992197|EG001|Reported Event|Rotarix, Double Dose|"Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life~Rotarix, dose 1: Rotarix, dose 1~Rotarix, dose 2: Rotarix, dose 2"
11296557|NCT02992236|BG000|Baseline|Placebo, Then VAS203|Participants first received Placebo (6 hours Infusion of Saline). After a washout period of 4 weeks, they then received VAS203 (6 hours Infusion of 10 mg/kg VAS203).
11296558|NCT02992236|BG001|Baseline|VAS203, Then Placebo|Participants first received VAS203 (6 hours Infusion of 10 mg/kg VAS203). After a washout period of 4 weeks, they then received Placebo (6 hours Infusion of Saline).
11296559|NCT02992236|BG002|Baseline|Total|Total of all reporting groups
11296560|NCT02992236|FG000|Participant Flow|Placebo, Then VAS203|Participants first received Placebo (6 hours Infusion of Saline). After a washout period of 4 weeks, they then received VAS203 (6 hours Infusion of 10 mg/kg VAS203).
11296561|NCT02992236|FG001|Participant Flow|VAS203, Then Placebo|Participants first received VAS203 (6 hours Infusion of 10 mg/kg VAS203). After a washout period of 4 weeks, they then received Placebo (6 hours Infusion of Saline).
10848288|NCT00289315|EG002|Reported Event|Arm 3|"Control~Control: Control program that does not include an active intervention for promoting healthy eating and physical activity."
11296562|NCT02992236|OG000|Outcome|Placebo|"Infusion (6 hours) of Saline~Saline: Infusion of saline"
11296563|NCT02992236|OG001|Outcome|VAS203|"Infusion (6 hours) of VAS203 (10 mg/kg)~VAS203: Infusion of NO-Synthase inhibitor VAS203"
11296564|NCT02992236|OG000|Outcome|VAS203|Six hours infusion of 10 mg/kg VAS203.
11296565|NCT02992236|OG001|Outcome|Placebo|Six hours Infusion of Saline
11296566|NCT02992236|EG000|Reported Event|Placebo|"Infusion (6 hours) of Saline~Saline: Infusion of saline"
11296567|NCT02992236|EG001|Reported Event|VAS203|"Infusion (6 hours) of VAS203 (10 mg/kg)~VAS203: Infusion of NO-Synthase inhibitor VAS203"
11296568|NCT02992288|BG000|Baseline|Placebo|Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
11296569|NCT02992288|BG001|Baseline|Neladenoson Bialanate 5 mg|Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
11296570|NCT02992288|BG002|Baseline|Neladenoson Bialanate 10 mg|Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296571|NCT02992288|BG003|Baseline|Neladenoson Bialanate 20 mg|Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296572|NCT02992288|BG004|Baseline|Neladenoson Bialanate 30 mg|Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296573|NCT02992288|BG005|Baseline|Neladenoson Bialanate 40 mg|Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296574|NCT02992288|BG006|Baseline|Total|Total of all reporting groups
11296575|NCT02992288|FG000|Participant Flow|Placebo|Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
11296576|NCT02992288|FG001|Participant Flow|Neladenoson Bialanate 5 mg|Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
11296577|NCT02992288|FG002|Participant Flow|Neladenoson Bialanate 10 mg|Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296578|NCT02992288|FG003|Participant Flow|Neladenoson Bialanate 20 mg|Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296579|NCT02992288|FG004|Participant Flow|Neladenoson Bialanate 30 mg|Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
10971311|NCT00915018|FG001|Participant Flow|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
11216990|NCT02310750|FG008|Participant Flow|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11216991|NCT02310750|FG009|Participant Flow|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11216992|NCT02310750|FG010|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216993|NCT02310750|FG011|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216994|NCT02310750|FG012|Participant Flow|PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216995|NCT02310750|FG013|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216996|NCT02310750|FG014|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216997|NCT02310750|FG015|Participant Flow|PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
11216998|NCT02310750|OG000|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11216999|NCT02310750|OG001|Outcome|PF--06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217000|NCT02310750|OG002|Outcome|PF--06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217001|NCT02310750|OG003|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217002|NCT02310750|OG004|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217003|NCT02310750|OG005|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217004|NCT02310750|OG006|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217005|NCT02310750|OG000|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
11217006|NCT02310750|OG001|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217007|NCT02310750|OG002|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217008|NCT02310750|OG003|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217009|NCT02310750|OG004|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217010|NCT02310750|OG005|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217011|NCT02310750|OG006|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11296580|NCT02992288|FG005|Participant Flow|Neladenoson Bialanate 40 mg|Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296581|NCT02992288|OG000|Outcome|Placebo|Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
11296582|NCT02992288|OG001|Outcome|Neladenoson Bialanate 5 mg|Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
11296583|NCT02992288|OG002|Outcome|Neladenoson Bialanate 10 mg|Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296584|NCT02992288|OG003|Outcome|Neladenoson Bialanate 20 mg|Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296585|NCT02992288|OG004|Outcome|Neladenoson Bialanate 30 mg|Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296586|NCT02992288|OG005|Outcome|Neladenoson Bialanate 40 mg|Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296587|NCT02992288|EG000|Reported Event|Placebo|Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
11296588|NCT02992288|EG001|Reported Event|Neladenoson Bialanate 5mg|Participants received 5 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296589|NCT02992288|EG002|Reported Event|Neladenoson Bialanate 10mg|Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296590|NCT02992288|EG003|Reported Event|Neladenoson Bialanate 20mg|Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296591|NCT02992288|EG004|Reported Event|Neladenoson Bialanate 30mg|Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296592|NCT02992288|EG005|Reported Event|Neladenoson Bialanate 40mg|Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
11296593|NCT02992691|BG000|Baseline|Overall Study|This was five-treatment, five-period, crossover design study. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million [ppm] fluoride).
11296594|NCT02992691|FG000|Participant Flow|Overall Study|This was a single-center, controlled, examiner-blind, five-treatment, five-period, crossover design study in healthy volunteers. Each participant received Test Product 1 (Dentifrice containing 20 percent [%] weight by weight [w/w] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride).
11296595|NCT02992691|OG000|Outcome|Positive Control|Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
10848289|NCT00289341|BG000|Baseline|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
10848290|NCT00289341|BG001|Baseline|Placebo|
10848291|NCT00289341|BG002|Baseline|Total|Total of all reporting groups
11296596|NCT02992691|OG001|Outcome|Negative Control|Participant applied a full ribbon of dentifrice containing 0% sodium bicarbonate and 1450 ppm fluoride and brushed their teeth for one timed minute.
11296597|NCT02992691|OG000|Outcome|Test Product 1|Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296598|NCT02992691|OG001|Outcome|Test Product 2|Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296599|NCT02992691|OG002|Outcome|Test Product 3|Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296600|NCT02992691|OG003|Outcome|Negative Control|Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
11296601|NCT02992691|OG001|Outcome|Test Product 2|Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute..
11296602|NCT02992691|OG003|Outcome|Positive Control|Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296603|NCT02992691|EG000|Reported Event|Test Product 1|Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296604|NCT02992691|EG001|Reported Event|Test Product 2|Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296605|NCT02992691|EG002|Reported Event|Test Product 3|Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296606|NCT02992691|EG003|Reported Event|Positive Control|Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
11296607|NCT02992691|EG004|Reported Event|Negative Control|Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
11332633|NCT03498287|OG001|Outcome|Sham Device|"Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.~Sham Device: Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase."
11332634|NCT03498287|EG000|Reported Event|Study Device|"Small, non-invasive, orthodontic arch with adhesive applied to the wrist~Study Device: Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks)."
11296608|NCT02992899|BG000|Baseline|Vagal Nerve Stimulation|"Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.~GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296609|NCT02992899|BG001|Baseline|Sham Stimulation|"Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.~Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296610|NCT02992899|BG002|Baseline|Total|Total of all reporting groups
11296611|NCT02992899|FG000|Participant Flow|Vagal Nerve Stimulation|"Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.~GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296612|NCT02992899|FG001|Participant Flow|Sham Stimulation|"Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.~Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296613|NCT02992899|OG000|Outcome|Vagal Nerve Stimulation|"Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.~GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11332635|NCT03498287|EG001|Reported Event|Sham Device|"Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.~Sham Device: Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase."
11332636|NCT03498300|BG000|Baseline|Experimental|"A single dose of Tdap vaccine at GA 27 - 36 weeks~Tdap vaccine: A single dose of Tdap vaccine at GA 27 - 36 weeks"
11332637|NCT03498300|BG001|Baseline|Active Comparator|dT vaccine as standard protocol
11332638|NCT03498300|BG002|Baseline|Total|Total of all reporting groups
11332639|NCT03498300|FG000|Participant Flow|Experimental|A single dose of Tdap vaccine at GA 27 - 36 weeks
11332640|NCT03498300|FG001|Participant Flow|Active Comparator|dT vaccine as standard protocol
10971312|NCT00915018|OG000|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
11296614|NCT02992899|OG001|Outcome|Sham Stimulation|"Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.~Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296615|NCT02992899|EG000|Reported Event|Vagal Nerve Stimulation|"Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.~GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296616|NCT02992899|EG001|Reported Event|Sham Stimulation|"Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.~Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.~O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts."
11296617|NCT02993224|BG000|Baseline|Deferasirox DT Followed by Deferasirox FCT|Participants were treated with deferasirox DT followed by deferasirox FCT (core phase). Those who entered the extension phase were treated with deferasirox FCT
11296618|NCT02993224|FG000|Participant Flow|Deferasirox DT Followed by Deferasirox FCT|Participants were treated with deferasirox DT followed by deferasirox FCT (core phase). Those who entered the extension phase were treated with deferasirox FCT
11296619|NCT02993224|OG000|Outcome|Deferasirox DT Followed by Deferasirox FCT|Participants were treated with deferasirox DT followed by deferasirox FCT (core phase). Those who entered the extension phase were treated with deferasirox FCT
11296620|NCT02993224|EG000|Reported Event|Deferasirox DT (Core Phase)|Participants who were treated with deferasirox DT once daily in the core phase
11296621|NCT02993224|EG001|Reported Event|Deferasirox FCT (Core Phase)|Participants who were treated with deferasirox FCT once daily in the core phase
11296622|NCT02993224|EG002|Reported Event|Deferasirox FCT (Extension Phase)|Participants who were treated with deferasirox FCT once daily in the extension phase
11296623|NCT02993250|BG000|Baseline|Cohort 1: Chronic Hepatitis C Without Cirrhosis|Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.
11296624|NCT02993250|BG001|Baseline|Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis|Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
11296625|NCT02993250|BG002|Baseline|Total|Total of all reporting groups
10971313|NCT00915018|OG001|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
10971314|NCT00915018|EG000|Reported Event|Neratinib+Paclitaxel|Neratinib + Paclitaxel
11296626|NCT02993250|FG000|Participant Flow|Cohort 1: Chronic Hepatitis C Without Cirrhosis|Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.
11296627|NCT02993250|FG001|Participant Flow|Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis|Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
11296628|NCT02993250|OG000|Outcome|Cohort 1: Chronic Hepatitis C Without Cirrhosis|Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.
11296629|NCT02993250|OG001|Outcome|Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis|Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
11296630|NCT02993250|EG000|Reported Event|Cohort 1: Chronic Hepatitis C Without Cirrhosis|Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.
10971315|NCT00915018|EG001|Reported Event|Trastuzumab+Paclitaxel|Trastuzumab + Paclitaxel
11296631|NCT02993250|EG001|Reported Event|Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis|Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
11296632|NCT02993302|BG000|Baseline|PTU + Oral 1α-D3|"patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~1α-D3: patients were given PTU and 1α-D3"
11296633|NCT02993302|BG001|Baseline|PTU + Placebos|"patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~Placebos: patients were given PTU and placebos"
11296634|NCT02993302|BG002|Baseline|Total|Total of all reporting groups
11296635|NCT02993302|FG000|Participant Flow|PTU + Oral 1α-D3|"patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~1α-D3: patients were given PTU and 1α-D3"
11296636|NCT02993302|FG001|Participant Flow|PTU + Placebos|"patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~Placebos: patients were given PTU and placebos"
11296637|NCT02993302|OG000|Outcome|PTU + Oral 1α-D3|"patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~1α-D3: patients were given PTU and 1α-D3"
11296638|NCT02993302|OG001|Outcome|PTU + Placebos|"patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~Placebos: patients were given PTU and placebos"
11296639|NCT02993302|EG000|Reported Event|PTU + Oral 1α-D3|"patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~1α-D3: patients were given PTU and 1α-D3"
11296640|NCT02993302|EG001|Reported Event|PTU + Placebos|"patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis~Placebos: patients were given PTU and placebos"
11296641|NCT02993445|BG000|Baseline|Alternate Nostril Breathing First, Then Foot Reflexology|"The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.~Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes."
11296642|NCT02993445|BG001|Baseline|Foot Reflexology First, Then Alternate Nostril Breathing|"The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.~Patients will complete 2 week wash out and then return for alternate nostril breathing.~The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes."
11296643|NCT02993445|BG002|Baseline|Total|Total of all reporting groups
11296644|NCT02993445|FG000|Participant Flow|Alternate Nostril Breathing First, Then Foot Reflexology|"The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.~Patients will complete 2 week wash out and then return for foot reflexology.~The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes."
11296645|NCT02993445|FG001|Participant Flow|Foot Reflexology First, Then Alternate Nostril Breathing|"The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.~Patients will complete 2 week wash out and then return for alternate nostril breathing.~The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes."
11296646|NCT02993445|OG000|Outcome|Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology|"The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.~Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes."
11296647|NCT02993445|OG001|Outcome|Foot Reflexology First, Then Alternate Nostril Breathing|"The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.~Patients will complete 2 week wash out and then return for alternate nostril breathing.~The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes."
11296648|NCT02993445|EG000|Reported Event|Alternate Nostril Breathing|"The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.~Alternate Nostril Breathing"
11296649|NCT02993445|EG001|Reported Event|Foot Reflexology|"The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.~Foot Reflexology"
11296650|NCT02993471|BG000|Baseline|Overall Study|Participants received drug cocktail and drug cocktail + Ixekizumab.
11332641|NCT03498300|OG000|Outcome|All Participants|After enrollment, a blood sample was obtained for determination of anti-PT IgG on the day of the first antenatal visit from all of the participants. If the anti-PT IgG level was 5 international units per milliliter (IU/ml) or more, the woman was considered to have seropositivity.
11332642|NCT03498300|OG000|Outcome|Experimental|A single dose of Tdap vaccine at GA 27 - 36 weeks
11332643|NCT03498300|OG001|Outcome|Active Comparator|dT vaccine as standard protocol
11332644|NCT03498300|EG000|Reported Event|Experimental|A single dose of Tdap vaccine at GA 27 - 36 weeks
11332645|NCT03498300|EG001|Reported Event|Active Comparator|dT vaccine as standard protocol
11332646|NCT03499028|BG000|Baseline|Standard of Care Group|The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone.
10842973|NCT00251004|OG001|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11296651|NCT02993471|FG000|Participant Flow|Drug Cocktail /Drug Cocktail + Ixekizumab|"Period 1: Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin [plus vitamin K], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1. Participants resided at the Clinical Research Unit (CRU) until Day 2, and were discharged following collection of 24-hour pharmacokinetics (PK) samples for the determination of plasma concentrations of the cocktail drugs and metabolites.~Period 2: Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12)."
11296652|NCT02993471|OG000|Outcome|1 mg Midazolam|Participants received 1 mg of Midazolam on Day 1 of Period 1.
11296653|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 1 mg Midazolam|Participants received 160 mg dose of Ixekizumab on Day 1 and 1 mg of Midazolam on Day 8 of Period 2.
11296654|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
11296655|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 1 mg Midazolam|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2.
11296656|NCT02993471|OG000|Outcome|10 mg Warfarin|Participants received 10 mg of Warfarin on Day 1 of Period 1.
11296657|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 10 mg Warfarin|Participants received 160 mg dose of Ixekizumab on Day 1 and 10 mg of Warfarin on Day 8 of Period 2.
11296658|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 10 mg Warfarin|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 10 mg of Warfarin on the following morning (Day 85; Week 12) during Period 2.
11296659|NCT02993471|OG000|Outcome|30 mg Dextromethorphan|Participants received 30 mg of Dextromethorphan on Day 1 of Period 1.
11296660|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 30 mg Dextromethorphan|Participants received 160 mg dose of Ixekizumab on Day 1 and 30 mg of Dextromethorphan on Day 8 of Period 2.
11296661|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 30 mg Dextromethorphan|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 30 mg of Dextromethorphan on the following morning (Day 85; Week 12) during Period 2.
11296662|NCT02993471|OG000|Outcome|20 mg Omeprazole|Participants received 20 mg of Omeprazole on Day 1 of Period 1.
11296663|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 20 mg Omeprazole|Participants received 160 mg dose of Ixekizumab on Day 1 and 20 mg of Omeprazole on Day 8 of Period 2.
11296664|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 20 mg Omeprazole|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 20 mg of Omeprazole on the following morning (Day 85; Week 12) during Period 2.
11296665|NCT02993471|OG000|Outcome|100 mg Caffeine|Participants received 100 mg of Caffeine on Day 1 of Period 1.
11296666|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 100 mg Caffeine|Participants received 160 mg dose of ixekizumab on Day 1 and 100 mg of Caffeine on Day 8 of Period 2.
11296667|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 100 mg Caffeine|Participants received 80 mg of ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of ixekizumab and 100 mg of Caffeine on the following morning (Day 85; Week 12) during Period 2.
10971316|NCT00915031|BG000|Baseline|Hypothermia Only OR|"Use of Hypothermia Cooling device only in the operating room~UroCool: Hypothermia Endorectal Device"
11296668|NCT02993471|OG001|Outcome|160 mg Ixekizumab + 100 mg Caffeine|Participants received 160 mg dose of Ixekizumab on Day 1 and 100 mg of Caffeine on Day 8 of Period 2.
11296669|NCT02993471|OG002|Outcome|80 mg Ixekizumab Q2W + 100 mg Caffeine|Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 100 mg of Caffeine on the following morning (Day 85; Week 12) during Period 2.
11296670|NCT02993471|EG000|Reported Event|Drug Cocktail|Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin [plus vitamin K], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1 of period 1.
11296671|NCT02993471|EG001|Reported Event|Drug Cocktail + Ixekizumab|Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12).
11296672|NCT02993783|BG000|Baseline|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296673|NCT02993783|BG001|Baseline|Vedolizumab 600 mg|Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296674|NCT02993783|BG002|Baseline|Total|Total of all reporting groups
11296675|NCT02993783|FG000|Participant Flow|Vedolizumab 300 mg|Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.
11296676|NCT02993783|FG001|Participant Flow|Vedolizumab 600 mg|Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296677|NCT02993783|OG000|Outcome|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296678|NCT02993783|OG001|Outcome|Vedolizumab 600 mg|Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296679|NCT02993783|EG000|Reported Event|Vedolizumab 300 mg|Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296680|NCT02993783|EG001|Reported Event|Vedolizumab 600 mg|Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
11296681|NCT02994056|BG000|Baseline|SOF/VEL+ RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296682|NCT02994056|FG000|Participant Flow|SOF/VEL+ RBV|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis
11296683|NCT02994056|OG000|Outcome|SOF/VEL+ RBV (Total)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296684|NCT02994056|OG001|Outcome|SOF/VEL+ RBV (GT-1)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
11296685|NCT02994056|OG002|Outcome|SOF/VEL+ RBV (GT-2)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
11296686|NCT02994056|OG003|Outcome|SOF/VEL+ RBV (GT-3)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
11296687|NCT02994056|OG000|Outcome|SOF/VEL+ RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296688|NCT02994056|OG000|Outcome|SOF/VEL+ RBV (Total)|SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296689|NCT02994056|OG000|Outcome|SOF/VEL+ RBV (GT-1)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
11296690|NCT02994056|OG001|Outcome|SOF/VEL+ RBV (GT-2)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
11296691|NCT02994056|OG002|Outcome|SOF/VEL+ RBV (GT-3)|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
11296692|NCT02994056|OG003|Outcome|SOF/VEL+ RBV (Total)|SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296693|NCT02994056|EG000|Reported Event|SOF/VEL+ RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
11296694|NCT02994108|BG000|Baseline|txt2protect|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination."
11296695|NCT02994108|BG001|Baseline|Sexual Health Control|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination."
11296696|NCT02994108|BG002|Baseline|Total|Total of all reporting groups
11296697|NCT02994108|FG000|Participant Flow|txt2protect|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination."
11296698|NCT02994108|FG001|Participant Flow|Sexual Health Control|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination."
11296699|NCT02994108|OG000|Outcome|txt2protect|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination."
11296700|NCT02994108|OG001|Outcome|Sexual Health Control|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination."
11296701|NCT02994108|OG001|Outcome|Sexual Health Control|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination."
11296702|NCT02994108|EG000|Reported Event|txt2protect|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination."
11296703|NCT02994108|EG001|Reported Event|Sexual Health Control|"Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 booster messages largely reinforced Phase 1 content to foster continued engagement with the program.~Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination."
11296704|NCT02994238|BG000|Baseline|Intervention|"The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).~Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management."
11296705|NCT02994238|BG001|Baseline|Control|The control group will receive only standardized education.
11296706|NCT02994238|BG002|Baseline|Total|Total of all reporting groups
11296707|NCT02994238|FG000|Participant Flow|Intervention|"The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).~Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management."
11296708|NCT02994238|FG001|Participant Flow|Control|The control group will receive only standardized education.
10971317|NCT00915031|BG001|Baseline|Hypothermia in OR + Recovery|"Use of hypothermia cooling device in the operating room and up to five hours after surgery.~UroCool: Hypothermia Endorectal Device"
10971318|NCT00915031|BG002|Baseline|Total|Total of all reporting groups
10971319|NCT00915031|FG000|Participant Flow|Hypothermia Only OR|"Use of Hypothermia Cooling device only in the operating room~UroCool: Hypothermia Endorectal Device"
10971320|NCT00915031|FG001|Participant Flow|Hypothermia in OR + Recovery|"Use of hypothermia cooling device in the operating room and up to five hours after surgery.~UroCool: Hypothermia Endorectal Device"
10971321|NCT00915031|OG000|Outcome|Hypothermia Only OR|"Use of Hypothermia Cooling device only in the operating room~UroCool: Hypothermia Endorectal Device"
10971322|NCT00915031|OG001|Outcome|Hypothermia in OR + Recovery|"Use of hypothermia cooling device in the operating room and up to five hours after surgery.~UroCool: Hypothermia Endorectal Device"
10971323|NCT00915031|EG000|Reported Event|General Adverse Events|"Both arms:~An adverse event (AE) is any undesirable experience (sign, symptom, significant laboratory abnormality, illness, or other medical event) occurring to a patient that appears or worsens during a clinical study, regardless of etiology.~Mild - Awareness of signs or symptoms that are easily tolerated. Signs and symptoms are transient and only of minor irritant type and cause no loss of time from normal activities; symptoms do not require medication or a medical evaluation.~Moderate - Discomfort severe enough to cause interference with usual activities. Symptoms may require treatment but not extended hospitalization or intensive care for the patient.~Severe - Incapacitating with inability to do work or usual activities. Signs and symptoms may be of systemic nature or require medical evaluation and/or treatment that requires prolonged hospital stay"
10971324|NCT00915148|BG000|Baseline|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
11296709|NCT02994238|OG000|Outcome|Intervention|"The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).~Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management."
11296710|NCT02994238|OG001|Outcome|Control|The control group will receive only standardized education.
11332647|NCT03499028|BG001|Baseline|Experimental (JointCOACH) Group|"The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires.~JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information"
11332648|NCT03499028|BG002|Baseline|Total|Total of all reporting groups
11332649|NCT03499028|FG000|Participant Flow|Standard of Care Group|The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone.
10971325|NCT00915148|FG000|Participant Flow|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
10971326|NCT00915148|OG000|Outcome|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
10971327|NCT00915148|OG000|Outcome|Women Delivered Within 6 Hours|"Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.~Ultrasound examinations: 2D transperineal scan"
10971328|NCT00915148|EG000|Reported Event|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
10971329|NCT00915278|BG000|Baseline|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971330|NCT00915278|BG001|Baseline|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971331|NCT00915278|BG002|Baseline|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971332|NCT00915278|BG003|Baseline|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971333|NCT00915278|BG004|Baseline|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971334|NCT00915278|BG005|Baseline|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971335|NCT00915278|BG006|Baseline|Total|Total of all reporting groups
10971336|NCT00915278|FG000|Participant Flow|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296711|NCT02994238|EG000|Reported Event|Intervention|"The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).~Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management."
11296712|NCT02994238|EG001|Reported Event|Control|The control group will receive only standardized education.
11296713|NCT02994394|BG000|Baseline|Cohort 1|"Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296714|NCT02994394|BG001|Baseline|Cohort 2|"Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296715|NCT02994394|BG002|Baseline|Total|Total of all reporting groups
11296716|NCT02994394|FG000|Participant Flow|Cohort 1: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water|"Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296717|NCT02994394|FG001|Participant Flow|Cohort 1: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water|"Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296718|NCT02994394|FG002|Participant Flow|Cohort 1: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet|"Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296719|NCT02994394|FG003|Participant Flow|Cohort 2: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water|"Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296720|NCT02994394|FG004|Participant Flow|Cohort 2: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water|"Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296721|NCT02994394|FG005|Participant Flow|Cohort 2: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet|"Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3.~A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3."
11296722|NCT02994394|OG000|Outcome|Cohort 1: 15 mg Conventional Tablet|Single oral administration of 1 tolvaptan 15 mg conventional tablet with water under fasting conditions
11296723|NCT02994394|OG001|Outcome|Cohort 1: 15 mg OD Tablet Without Water|Single oral administration of 1 tolvaptan 15 mg OD tablet without water under fasting conditions
11296724|NCT02994394|OG002|Outcome|Cohort 1: 15 mg OD Tablet With Water|Single oral administration of 1 tolvaptan 15 mg OD tablet with water under fasting conditions
11296725|NCT02994394|OG003|Outcome|Cohort 2: 30 mg Conventional Tablet|Single oral administration of 1 tolvaptan 30 mg conventional tablet with water under fasting conditions
11296726|NCT02994394|OG004|Outcome|Cohort 2: 30 mg OD Tablet Without Water|Single oral administration of 1 tolvaptan 30 mg OD tablet without water under fasting conditions
11296727|NCT02994394|OG005|Outcome|Cohort 2: 30 mg OD Tablet With Water|Single oral administration of 1 tolvaptan 30 mg OD tablet with water under fasting conditions
11296728|NCT02994394|EG000|Reported Event|Cohort 1: 15 mg Conventional Tablet|Single oral administration of 1 tolvaptan 15 mg conventional tablet with water under fasting conditions
11296729|NCT02994394|EG001|Reported Event|Cohort 1: 15 mg OD Tablet Without Water|Single oral administration of 1 tolvaptan 15 mg OD tablet without water under fasting conditions
11296730|NCT02994394|EG002|Reported Event|Cohort 1: 15 mg OD Tablet With Water|Single oral administration of 1 tolvaptan 15 mg OD tablet with water under fasting conditions
11296731|NCT02994394|EG003|Reported Event|Cohort 2: 30 mg Conventional Tablet|Single oral administration of 1 tolvaptan 30 mg conventional tablet with water under fasting conditions
11296732|NCT02994394|EG004|Reported Event|Cohort 2: 30 mg OD Tablet Without Water|Single oral administration of 1 tolvaptan 30 mg OD tablet without water under fasting conditions
11296733|NCT02994394|EG005|Reported Event|Cohort 2: 30 mg OD Tablet With Water|Single oral administration of 1 tolvaptan 30 mg OD tablet with water under fasting conditions
11296734|NCT02994654|BG000|Baseline|Experimental: All Participants (Within Patient Control)|All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).
11296735|NCT02994654|FG000|Participant Flow|Experimental: All Participants (Within Patient Control)|Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before the areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan).
11296736|NCT02994654|OG000|Outcome|ReCell|"All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B~ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.~The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded."
11296737|NCT02994654|OG001|Outcome|Control|"All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B~ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.~The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded."
11296738|NCT02994654|EG000|Reported Event|All Participants|All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).
11296739|NCT02994732|BG000|Baseline|Single Arm Study|Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
11296740|NCT02994732|FG000|Participant Flow|Experimental [14C] - BVD-523 600mg Single Dose|Subjects received a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that followed breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
11296741|NCT02994732|OG000|Outcome|Experimental [14C] -BVD-523 600mg Single Dose|Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
11296742|NCT02994732|OG000|Outcome|Single Arm Study|Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
11296743|NCT02994732|EG000|Reported Event|Single Arm Study|Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
11296744|NCT02994940|BG000|Baseline|Oral Acetaminophen|"Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.~Acetaminophen"
11296745|NCT02994940|BG001|Baseline|Intravenous Acetaminophen|"Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.~Acetaminophen"
10971337|NCT00915278|FG001|Participant Flow|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296746|NCT02994940|BG002|Baseline|Total|Total of all reporting groups
11296747|NCT02994940|FG000|Participant Flow|Oral Acetaminophen|"Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.~Acetaminophen"
11296748|NCT02994940|FG001|Participant Flow|Intravenous Acetaminophen|"Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.~Acetaminophen"
11296749|NCT02994940|OG000|Outcome|Oral Acetaminophen|"Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.~Acetaminophen"
10971338|NCT00915278|FG002|Participant Flow|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971339|NCT00915278|FG003|Participant Flow|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296750|NCT02994940|OG001|Outcome|Intravenous Acetaminophen|"Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.~Acetaminophen"
11296751|NCT02994940|EG000|Reported Event|Oral Acetaminophen|"Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.~Acetaminophen"
11296752|NCT02994940|EG001|Reported Event|Intravenous Acetaminophen|"Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.~Acetaminophen"
11296753|NCT02994979|BG000|Baseline|Delirium-prevention Group|Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
11296754|NCT02994979|BG001|Baseline|Usual Care Group|"Usual care plus a sham visit from the intervention CNA~Sham comparator: Usual care plus sham visits by CNA"
11296755|NCT02994979|BG002|Baseline|Total|Total of all reporting groups
11296756|NCT02994979|FG000|Participant Flow|Delirium-prevention Group|"Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.~Delirium-prevention: Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing 24-hour report). During"
11296757|NCT02994979|FG001|Participant Flow|Usual Care Group|"Usual care plus a sham visit from the intervention CNA~Sham comparator: Usual care plus sham visits by CNA"
11296758|NCT02994979|OG000|Outcome|Delirium-prevention Group|Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
11296759|NCT02994979|OG001|Outcome|Usual Care Group|"Usual care plus a sham visit from the intervention CNA~Sham comparator: Usual care plus sham visits by CNA"
11296760|NCT02994979|EG000|Reported Event|Delirium-prevention Group|Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
11296761|NCT02994979|EG001|Reported Event|Usual Care Group|"Usual care plus a sham visit from the intervention CNA~Sham comparator: Usual care plus sham visits by CNA"
10971340|NCT00915278|FG004|Participant Flow|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296762|NCT02995915|BG000|Baseline|Tele-health Mobile Contingency Management Intervention|"This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence."
11296763|NCT02995915|BG001|Baseline|Tele-health for Alcohol and Smoking Cessation|"This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence."
11296764|NCT02995915|BG002|Baseline|Total|Total of all reporting groups
10971341|NCT00915278|FG005|Participant Flow|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11332650|NCT03499028|FG001|Participant Flow|Experimental (JointCOACH) Group|"The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires.~JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information"
11332651|NCT03499028|OG000|Outcome|Standard of Care Group|The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone.
11332652|NCT03499028|OG001|Outcome|Experimental (JointCOACH) Group|"The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires.~JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information"
11332653|NCT03499028|OG000|Outcome|Provider Satisfaction|For this outcome, providers were asked about their satisfaction with JointCOACH. No arms were designated for this outcome.
10971342|NCT00915278|OG000|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11332654|NCT03499028|OG000|Outcome|Provider Satisfaction|For this outcome, providers were asked about whether they would recommend the use of JointCOACH. No arms were designated for this outcome.
11332655|NCT03499028|EG000|Reported Event|Standard of Care Group|The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone.
11332656|NCT03499028|EG001|Reported Event|Experimental (JointCOACH) Group|"The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires.~JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information"
11332657|NCT03499067|BG000|Baseline|Overall Study|Total participants
11332658|NCT03499067|FG000|Participant Flow|Test Lens Then Control Lens|"Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study.~Test lens: Contact lens~Control lens: Contact lens"
11332659|NCT03499067|FG001|Participant Flow|Control Lens Then Test Lens|"Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study.~Test lens: Contact lens~Control lens: Contact lens"
11332660|NCT03499067|OG000|Outcome|Test Lens|"Subjects were randomized to wear test contact lens for one month in this cross-over study.~Test lens: Contact lens"
11332661|NCT03499067|OG001|Outcome|Control Lens|"Subjects were randomized to wear control contact lens for one month in this cross-over study.~Control lens: Contact lens"
11332662|NCT03499067|EG000|Reported Event|Test Lens|"Subjects were randomized to wear test contact lens for one month in this cross-over study.~Test lens: Contact lens"
11332663|NCT03499067|EG001|Reported Event|Control Lens|"Subjects were randomized to wear control contact lens for one month in this cross-over study.~Control lens: Contact lens"
11332664|NCT03499353|BG000|Baseline|Talazoparib 1 mg QD|"During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.~Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).~Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS)."
11332665|NCT03499353|FG000|Participant Flow|Talazoparib 1 mg QD|"During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.~Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).~Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS)."
11332666|NCT03499353|OG000|Outcome|Talazoparib 1 mg QD|"During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.~Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).~Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS)."
11332667|NCT03499353|EG000|Reported Event|Talazoparib 1 mg QD|"During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.~Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).~Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS)."
11296765|NCT02995915|FG000|Participant Flow|Tele-health Mobile Contingency Management Intervention|"This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence."
11296766|NCT02995915|FG001|Participant Flow|Tele-health for Alcohol and Smoking Cessation|"This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence."
11296767|NCT02995915|OG000|Outcome|Tele-health Mobile Contingency Management Intervention|"This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence."
11296768|NCT02995915|OG001|Outcome|Tele-health for Alcohol and Smoking Cessation|"This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence."
11332668|NCT03499873|BG000|Baseline|Nepafenac 0.3% Opthalmic Suspension|"Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.~Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)"
11332669|NCT03499873|BG001|Baseline|Ilevro 0.3% Opthalmic Suspension|"Reference product manufactured by Alcon Laboratories Inc.~Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)"
11332670|NCT03499873|BG002|Baseline|Placebo (Vehicle) Opthalmic Suspension|"Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.~Placebos: Placebo"
11332671|NCT03499873|BG003|Baseline|Total|Total of all reporting groups
11332672|NCT03499873|FG000|Participant Flow|Nepafenac 0.3% Opthalmic Suspension|"Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.~Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)"
11332673|NCT03499873|FG001|Participant Flow|Ilevro 0.3% Opthalmic Suspension|"Reference product manufactured by Alcon Laboratories Inc.~Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)"
10848292|NCT00289341|FG000|Participant Flow|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
10848293|NCT00289341|FG001|Participant Flow|Placebo|
11296769|NCT02995915|EG000|Reported Event|Tele-health Mobile Contingency Management Intervention|"This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence."
11296770|NCT02995915|EG001|Reported Event|Tele-health for Alcohol and Smoking Cessation|"This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.~Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings~Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.~Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.~Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence."
11296771|NCT02995980|BG000|Baseline|Contrast Enhanced Mammography vs Standard Digital Mammograpm|"Contrast-enhanced spectral mammography for the detection breast cancer .~DECE mammography: Contrast mammography"
11296772|NCT02995980|FG000|Participant Flow|Contrast Enhanced Mammography vs Standard Digital Mammograpm|"Contrast-enhanced spectral mammography for the detection breast cancer .~Dual-Energy Contrast-Enhanced (DECE) mammography: Contrast mammography"
11296773|NCT02995980|OG000|Outcome|Contrast Enhanced Mammography|"Contrast-enhanced spectral mammography for the detection breast cancer .~DECE mammography: Contrast mammography"
11296774|NCT02995980|OG001|Outcome|Standard Digital Mammogram|"Full field digital mammography for the detection breast cancer~digital mammography: routine digital mammography"
11296775|NCT02995980|EG000|Reported Event|Contrast Enhanced Mammography vs Standard Digital Mammograpm|"Contrast-enhanced spectral mammography for the detection breast cancer .~DECE mammography: Contrast mammography"
11296776|NCT02996097|BG000|Baseline|All Participants|All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study.
11296777|NCT02996097|FG000|Participant Flow|CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide|A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.
11296778|NCT02996097|FG001|Participant Flow|Intralesional Triamcinolone Acetonide Only|A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.
11296779|NCT02996097|OG000|Outcome|CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide|A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.
11296780|NCT02996097|OG001|Outcome|Intralesional Triamcinolone Acetonide Only|A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.
11296781|NCT02996097|EG000|Reported Event|CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide|2 keloids on each patient will be selected as treatment sites. A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals. The other keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.
11296782|NCT02996448|BG000|Baseline|Vaccination Group- Single Arm Study|"Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.~NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection."
11332674|NCT03499873|FG002|Participant Flow|Placebo (Vehicle) Opthalmic Suspension|"Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.~Placebos: Placebo"
11296783|NCT02996448|FG000|Participant Flow|Vaccination Group, Single Arm Study|"Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.~NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection."
11296784|NCT02996448|OG000|Outcome|Vaccine Recipients|"Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.~NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection."
11296785|NCT02996448|OG000|Outcome|Vaccination Group- Single Arm Study|"Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.~NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection."
11296786|NCT02996448|EG000|Reported Event|Vaccination Group- Single Arm Study|"Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.~NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection."
11296787|NCT02996474|BG000|Baseline|Pembrolizumab and Decitabine for Treatment of AML|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
11296788|NCT02996474|FG000|Participant Flow|Pembrolizumab and Decitabine for Treatment of AML|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
11296789|NCT02996474|OG000|Outcome|Pembrolizumab and Decitabine for Treatment of AML|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
11296790|NCT02996474|EG000|Reported Event|Pembrolizumab and Decitabine for Treatment of AML|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
11296791|NCT02996500|BG000|Baseline|Placebo|Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296792|NCT02996500|BG001|Baseline|Tofa 10 mg|Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
11296793|NCT02996500|BG002|Baseline|PF-06650833 20 mg|Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296794|NCT02996500|BG003|Baseline|PF-06650833 60 mg|Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296795|NCT02996500|BG004|Baseline|PF-06650833 200 mg|Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
10971343|NCT00915278|OG001|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296796|NCT02996500|BG005|Baseline|PF-06650833 400 mg|Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296797|NCT02996500|BG006|Baseline|Total|Total of all reporting groups
11296798|NCT02996500|FG000|Participant Flow|Placebo|Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296799|NCT02996500|FG001|Participant Flow|Tofa 10 mg|Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
11296800|NCT02996500|FG002|Participant Flow|PF-06650833 20 mg|Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296801|NCT02996500|FG003|Participant Flow|PF-06650833 60 mg|Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296802|NCT02996500|FG004|Participant Flow|PF-06650833 200 mg|Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296803|NCT02996500|FG005|Participant Flow|PF-06650833 400 mg|Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296804|NCT02996500|OG000|Outcome|Placebo|Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296805|NCT02996500|OG001|Outcome|PF-06650833 20 mg|Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296806|NCT02996500|OG002|Outcome|PF-06650833 60 mg|Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
10848294|NCT00289341|OG000|Outcome|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
10848295|NCT00289341|OG001|Outcome|Placebo|12 patients receiving vehicle only
10848296|NCT00289341|OG000|Outcome|Median Difference, Post-Pre Vaccination|For each antigen group, the difference between the post and pre-vaccination T cell proliferation response was calculated.
10848297|NCT00289341|OG000|Outcome|Pre-vs Post-vaccination PSA Slope|
10848298|NCT00289341|EG000|Reported Event|Arm 2 Placebo Phase|Single-blind
10848299|NCT00289341|EG001|Reported Event|Arm 1 Vaccine Phase|Single blind
10848300|NCT00289341|EG002|Reported Event|Arm 2 Vaccine Phase|Unblinded
11296807|NCT02996500|OG003|Outcome|PF-06650833 200 mg|Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296808|NCT02996500|OG004|Outcome|PF-06650833 400 mg|Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296809|NCT02996500|OG001|Outcome|Tofa 10 mg|Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
11296810|NCT02996500|OG002|Outcome|PF-06650833 20 mg|Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296811|NCT02996500|OG003|Outcome|PF-06650833 60 mg|Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296812|NCT02996500|OG004|Outcome|PF-06650833 200 mg|Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296813|NCT02996500|OG005|Outcome|PF-06650833 400 mg|Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296814|NCT02996500|EG000|Reported Event|Placebo|Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
11296815|NCT02996500|EG001|Reported Event|Tofa 10 mg|Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
11296816|NCT02996500|EG002|Reported Event|PF-06650833 20 mg|Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296817|NCT02996500|EG003|Reported Event|PF-06650833 60 mg|Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296818|NCT02996500|EG004|Reported Event|PF-06650833 200 mg|Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296819|NCT02996500|EG005|Reported Event|PF-06650833 400 mg|Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
11296820|NCT02996591|BG000|Baseline|Spinal Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~45-60 mg of 1.5% mepivacaine for"
11296821|NCT02996591|BG001|Baseline|General Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia"
11296822|NCT02996591|BG002|Baseline|Total|Total of all reporting groups
11296823|NCT02996591|FG000|Participant Flow|Spinal Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~45-60 mg of 1.5% mepivacaine for"
10848301|NCT00289341|EG003|Reported Event|Arm 1 and 2 Post-Vaccination Phase|unblinded
10848302|NCT00289458|BG000|Baseline|Control Group|Continued with usual activity and care, no intervention
11332675|NCT03499873|OG000|Outcome|Nepafenac 0.3% Opthalmic Suspension|"Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.~Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)"
11332676|NCT03499873|OG001|Outcome|Ilevro 0.3% Opthalmic Suspension|"Reference product manufactured by Alcon Laboratories Inc.~Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)"
11332677|NCT03499873|OG002|Outcome|Placebo (Vehicle) Opthalmic Suspension|"Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.~Placebos: Placebo"
11332678|NCT03499873|EG000|Reported Event|Nepafenac 0.3% Opthalmic Suspension|"Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.~Nepafenac 0.3% Oph Susp: Nepafenac 0.3% Ophthalmic suspension (experimental product)"
11296824|NCT02996591|FG001|Participant Flow|General Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia"
11296825|NCT02996591|OG000|Outcome|Spinal Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~45-60 mg of 1.5% mepivacaine for"
11332679|NCT03499873|EG001|Reported Event|Ilevro 0.3% Opthalmic Suspension|"Reference product manufactured by Alcon Laboratories Inc.~Nepafenac 0.3% Oph Susp (reference): Nepafenac 0.3% Ophthalmic suspension (Innovator)"
11332680|NCT03499873|EG002|Reported Event|Placebo (Vehicle) Opthalmic Suspension|"Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.~Placebos: Placebo"
11332681|NCT03500094|BG000|Baseline|Migalastat HCl 150 mg|Migalastat was administered every other day for 12 months.
11332682|NCT03500094|FG000|Participant Flow|Migalastat HCl 150 mg|Migalastat was administered every other day for 12 months.
11332683|NCT03500094|OG000|Outcome|Migalastat HCl 150 mg|Migalastat was administered every other day for 12 months.
11332684|NCT03500094|OG000|Outcome|Migalastat HCl 150 mg: ERT Naive|Migalastat was administered every other day for 12 months to ERT Naive participants.
11332685|NCT03500094|OG001|Outcome|Migalastat HCl 150 mg: ERT Experienced|Migalastat was administered every other day for 12 months to ERT experienced participants.
11332686|NCT03500094|EG000|Reported Event|Migalastat HCl 150 mg|Migalastat was administered every other day for 12 months.
11332687|NCT03500198|BG000|Baseline|Investigational Device: ZHR00|Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
10848303|NCT00289458|BG001|Baseline|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
10848304|NCT00289458|BG002|Baseline|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
10848305|NCT00289458|BG003|Baseline|Total|Total of all reporting groups
11332688|NCT03500198|BG001|Baseline|Control Device: ZCB00|TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
11332689|NCT03500198|BG002|Baseline|Total|Total of all reporting groups
11332690|NCT03500198|FG000|Participant Flow|Investigational Device: ZHR00|Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
11332691|NCT03500198|FG001|Participant Flow|Control Device: ZCB00|TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
11332692|NCT03500198|OG000|Outcome|Investigational Device: ZHR00|Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
11332693|NCT03500198|OG001|Outcome|Control Device: ZCB00|TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
11332694|NCT03500198|EG000|Reported Event|Investigational Device: ZHR00 (First Eye)|Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.
11332695|NCT03500198|EG001|Reported Event|Control Device: ZCB00 (First Eye)|Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.
11332696|NCT03500198|EG002|Reported Event|Investigational Device: ZHR00 (Second Eye)|Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.
11332697|NCT03500198|EG003|Reported Event|Control Device: ZCB00 (Second Eye)|Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.
11332698|NCT03500211|BG000|Baseline|Lidoderm 5% Topical Patch|"5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery."
10848306|NCT00289458|FG000|Participant Flow|Control Group|Continued with usual activity and care, no intervention
10848307|NCT00289458|FG001|Participant Flow|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
10848308|NCT00289458|FG002|Participant Flow|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
11296826|NCT02996591|OG001|Outcome|General Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia"
11296827|NCT02996591|EG000|Reported Event|Spinal Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~45-60 mg of 1.5% mepivacaine for"
11296828|NCT02996591|EG001|Reported Event|General Anesthesia With Popliteal and Adductor Canal Blocks.|"Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.~25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block~10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block~Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed~LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia"
11296829|NCT02996682|BG000|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
11296830|NCT02996682|BG001|Baseline|SOF/VEL + RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
11296831|NCT02996682|BG002|Baseline|Total|Total of all reporting groups
11296832|NCT02996682|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
11296833|NCT02996682|FG001|Participant Flow|SOF/VEL + RBV|SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin (RBV) capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
11296834|NCT02996682|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
11296835|NCT02996682|OG001|Outcome|SOF/VEL + RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
11296836|NCT02996682|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
11296837|NCT02996682|EG001|Reported Event|SOF/VEL + RBV|SOF/VEL (400/100 mg) FDC tablet once daily + RBV capsules (600, 800, or 1,000 mg daily based on weight and CPT class) for 12 weeks
11296838|NCT02996864|BG000|Baseline|Healthy Detours App|"Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.~Healthy Detours App: The app features:~Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.~User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.~Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring."
11296839|NCT02996864|BG001|Baseline|Fat Secret App|"Participants will be encouraged to use the FatSecret application daily to track food and physical activity.~Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting."
11296840|NCT02996864|BG002|Baseline|Total|Total of all reporting groups
11296841|NCT02996864|FG000|Participant Flow|Healthy Detours App|"Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.~Healthy Detours App: The app features:~Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.~User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.~Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring."
11296842|NCT02996864|FG001|Participant Flow|Fat Secret App|"Participants will be encouraged to use the FatSecret application daily to track food and physical activity.~Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting."
11296843|NCT02996864|OG000|Outcome|Healthy Detours App|"Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.~Healthy Detours App: The app features:~Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.~User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.~Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring."
11296844|NCT02996864|OG001|Outcome|Fat Secret App|"Participants will be encouraged to use the FatSecret application daily to track food and physical activity.~Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting."
11296845|NCT02996864|EG000|Reported Event|Healthy Detours App|"Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.~Healthy Detours App: The app features:~Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.~User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.~Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring."
11296846|NCT02996864|EG001|Reported Event|Fat Secret App|"Participants will be encouraged to use the FatSecret application daily to track food and physical activity.~Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting."
11296847|NCT02996968|BG000|Baseline|Self-discontinuation Group|The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
11296848|NCT02996968|BG001|Baseline|Office-discontinuation Group|The patients randomized to the discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
11296849|NCT02996968|BG002|Baseline|Total|Total of all reporting groups
11296850|NCT02996968|FG000|Participant Flow|Self-discontinuation Group|The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
11296851|NCT02996968|FG001|Participant Flow|Office-discontinuation Group|The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
11296852|NCT02996968|OG000|Outcome|Self-discontinuation Group|The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
11296853|NCT02996968|OG001|Outcome|Office-discontinuation Group|The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
11296854|NCT02996968|EG000|Reported Event|Self-discontinuation Group|The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
10848309|NCT00289458|OG000|Outcome|Control Group|Continued with usual activity and care, no intervention
10848310|NCT00289458|OG001|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
11296855|NCT02996968|EG001|Reported Event|Office-discontinuation Group|The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
11296856|NCT02997085|BG000|Baseline|Live-Action 360° Video Virtual Reality|Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
11296857|NCT02997085|BG001|Baseline|CGI 360° Video Virtual Reality|CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
11296858|NCT02997085|BG002|Baseline|Waitlist|Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
11296859|NCT02997085|BG003|Baseline|Total|Total of all reporting groups
11332699|NCT03500211|BG001|Baseline|Sham Topical Patch|"Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Sham Topical Patch: Sham patch after cesarean section delivery."
11332700|NCT03500211|BG002|Baseline|Total|Total of all reporting groups
11332701|NCT03500211|FG000|Participant Flow|Lidoderm 5% Topical Patch|"5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery."
11217012|NCT02310750|OG000|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217013|NCT02310750|OG001|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217014|NCT02310750|OG002|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217015|NCT02310750|OG007|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
11217016|NCT02310750|OG008|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217017|NCT02310750|OG009|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217018|NCT02310750|OG010|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217019|NCT02310750|OG011|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217020|NCT02310750|OG012|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217021|NCT02310750|OG013|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217022|NCT02310750|OG014|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217023|NCT02310750|OG015|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217024|NCT02310750|OG016|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217025|NCT02310750|OG017|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217026|NCT02310750|OG018|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217027|NCT02310750|OG019|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217028|NCT02310750|OG007|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217029|NCT02310750|OG008|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217030|NCT02310750|OG009|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217031|NCT02310750|OG000|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217032|NCT02310750|OG001|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217033|NCT02310750|OG002|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217034|NCT02310750|OG000|Outcome|PF--06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217035|NCT02310750|OG001|Outcome|PF--06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217036|NCT02310750|OG002|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217037|NCT02310750|OG003|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217038|NCT02310750|OG004|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217039|NCT02310750|OG005|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11296860|NCT02997085|FG000|Participant Flow|Live-Action 360° Video Virtual Reality|Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
11296861|NCT02997085|FG001|Participant Flow|CGI 360° Video Virtual Reality|CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
11296862|NCT02997085|FG002|Participant Flow|Waitlist|Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
11296863|NCT02997085|OG000|Outcome|Live-Action 360° Video Virtual Reality|Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
11296864|NCT02997085|OG001|Outcome|CGI 360° Video Virtual Reality|CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
11296865|NCT02997085|OG002|Outcome|Waitlist|Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
10971344|NCT00915278|OG002|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971345|NCT00915278|OG003|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971346|NCT00915278|OG004|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971347|NCT00915278|OG005|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971348|NCT00915278|EG000|Reported Event|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296866|NCT02997085|EG000|Reported Event|Live-Action 360° Video Virtual Reality|Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
11296867|NCT02997085|EG001|Reported Event|CGI 360° Video Virtual Reality|CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
11296868|NCT02997163|BG000|Baseline|Normal Renal Function|Participants with normal renal function (eGFR >= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
10971349|NCT00915278|EG001|Reported Event|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971350|NCT00915278|EG002|Reported Event|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971351|NCT00915278|EG003|Reported Event|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296869|NCT02997163|BG001|Baseline|Mild Renal Impairment|Participants with mild renal function (eGFR >= 60 and >=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296870|NCT02997163|BG002|Baseline|Moderate Renal Impairment|Participants with moderate renal function (eGFR >= 30 and <=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296871|NCT02997163|BG003|Baseline|Severe Renal Impairment|Participants with severe renal function (eGFR >= 15 and <= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296872|NCT02997163|BG004|Baseline|Total|Total of all reporting groups
11296873|NCT02997163|FG000|Participant Flow|Normal Renal Function|Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73m^2]) received 0.5 milligrams (mg) (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296874|NCT02997163|FG001|Participant Flow|Mild Renal Impairment|Participants with mild renal function (eGFR >= 60 and less than or equal to [<=] 89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296875|NCT02997163|FG002|Participant Flow|Moderate Renal Impairment|Participants with moderate renal function (eGFR >= 30 and <=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296876|NCT02997163|FG003|Participant Flow|Severe Renal Impairment|Participants with severe renal function (eGFR >= 15 and <= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296877|NCT02997163|OG000|Outcome|Normal Renal Function|Participants with normal renal function (eGFR >= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296878|NCT02997163|OG001|Outcome|Mild Renal Impairment|Participants with mild renal function (eGFR >= 60 and >=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296879|NCT02997163|OG002|Outcome|Moderate Renal Impairment|Participants with moderate renal function (eGFR >= 30 and <=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296880|NCT02997163|OG003|Outcome|Severe Renal Impairment|Participants with severe renal function (eGFR >= 15 and <= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296881|NCT02997163|EG000|Reported Event|Normal Renal Function|Participants with normal renal function (eGFR >= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296882|NCT02997163|EG001|Reported Event|Mild Renal Impairment|Participants with mild renal function (eGFR >= 60 and >=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296883|NCT02997163|EG002|Reported Event|Moderate Renal Impairment|Participants with moderate renal function (eGFR >= 30 and <=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296884|NCT02997163|EG003|Reported Event|Severe Renal Impairment|Participants with severe renal function (eGFR >= 15 and <= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296885|NCT02997176|BG000|Baseline|Talazoparib: Normal Hepatic Function|Participants with TB and AST <=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296886|NCT02997176|BG001|Baseline|Talazoparib: Mild Hepatic Impairment|Participants with TB <=ULN and AST greater than (>) ULN or TB >1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296887|NCT02997176|BG002|Baseline|Talazoparib: Moderate Hepatic Impairment|Participants with TB >1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296888|NCT02997176|BG003|Baseline|Talazoparib: Severe Hepatic Impairment|Participants with TB >3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296889|NCT02997176|BG004|Baseline|Total|Total of all reporting groups
11296890|NCT02997176|FG000|Participant Flow|Talazoparib: Normal Hepatic Function|Participants with total bilirubin (TB) and aspartate aminotransferase (AST) less than or equal to (<=) upper limit of normal (ULN), received talazoparib 0.5 milligram (mg) (2 capsules of 0.25 mg), orally once daily for 22 days.
11296891|NCT02997176|FG001|Participant Flow|Talazoparib: Mild Hepatic Impairment|Participants with TB <=ULN and AST greater than (>) ULN or TB >1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296892|NCT02997176|FG002|Participant Flow|Talazoparib: Moderate Hepatic Impairment|Participants with TB >1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296893|NCT02997176|FG003|Participant Flow|Talazoparib: Severe Hepatic Impairment|Participants with TB >3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296894|NCT02997176|OG000|Outcome|Talazoparib: Normal Hepatic Function|Participants with TB and AST <=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296895|NCT02997176|OG001|Outcome|Talazoparib: Mild Hepatic Impairment|Participants with TB <=ULN and AST greater than (>) ULN or TB >1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
10848311|NCT00289458|OG002|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
11296896|NCT02997176|OG002|Outcome|Talazoparib: Moderate Hepatic Impairment|Participants with TB >1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296897|NCT02997176|OG003|Outcome|Talazoparib: Severe Hepatic Impairment|Participants with TB >3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296898|NCT02997176|EG000|Reported Event|Talazoparib: Normal Hepatic Function|Participants with TB and AST <=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.
11296899|NCT02997176|EG001|Reported Event|Talazoparib: Mild Hepatic Impairment|Participants with TB <=ULN and AST greater than (>) ULN or TB >1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296900|NCT02997176|EG002|Reported Event|Talazoparib: Moderate Hepatic Impairment|Participants with TB >1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296901|NCT02997176|EG003|Reported Event|Talazoparib: Severe Hepatic Impairment|Participants with TB >3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
11296902|NCT02997722|BG000|Baseline|Ketamine Infusion|"Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.~Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes."
11296903|NCT02997722|BG001|Baseline|Normal Saline Infusion|"Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.~Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes."
10971352|NCT00915278|EG004|Reported Event|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
10971353|NCT00915278|EG005|Reported Event|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
11296904|NCT02997722|BG002|Baseline|Total|Total of all reporting groups
11296905|NCT02997722|FG000|Participant Flow|Ketamine Infusion|"Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.~Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes."
11296906|NCT02997722|FG001|Participant Flow|Normal Saline Infusion|"Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.~Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes."
11296907|NCT02997722|OG000|Outcome|Ketamine Infusion|"Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.~Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes."
11296908|NCT02997722|OG001|Outcome|Normal Saline Infusion|"Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.~Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes."
11296909|NCT02997722|EG000|Reported Event|Ketamine Infusion|"Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.~Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes."
11296910|NCT02997722|EG001|Reported Event|Normal Saline Infusion|"Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.~Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes."
11296911|NCT02997735|BG000|Baseline|eReferral|"Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours)."
11296912|NCT02997735|BG001|Baseline|Control|"Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent."
11296913|NCT02997735|BG002|Baseline|Total|Total of all reporting groups
11296914|NCT02997735|FG000|Participant Flow|eReferral|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours)."
11296915|NCT02997735|FG001|Participant Flow|Control|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent."
11296916|NCT02997735|OG000|Outcome|eReferral|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours)."
11296917|NCT02997735|OG001|Outcome|Control|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent."
11296918|NCT02997735|EG000|Reported Event|eReferral|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours)."
11296919|NCT02997735|EG001|Reported Event|Control|"Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent."
11296920|NCT02997904|BG000|Baseline|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296921|NCT02997904|BG001|Baseline|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296922|NCT02997904|BG002|Baseline|Total|Total of all reporting groups
11296923|NCT02997904|FG000|Participant Flow|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
10848312|NCT00289458|EG000|Reported Event|Control Group|Continued with usual activity and care, no intervention
11296924|NCT02997904|FG001|Participant Flow|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296925|NCT02997904|OG000|Outcome|Resultz Lice and Egg Elimination Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
10848313|NCT00289458|EG001|Reported Event|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
11296926|NCT02997904|OG001|Outcome|Sham Lice and Egg Elimination Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296927|NCT02997904|OG000|Outcome|Number or Lice Removed by Resultz|Total number of lice removed after one hour of combing with Resultz; analyzed separately
11296928|NCT02997904|OG001|Outcome|Number of Lice Removed by Control|Total number of lice removed after one hour of combing by control; analyzed separately
11296929|NCT02997904|OG002|Outcome|Number of Eggs Removed by Resultz|Total number of eggs removed after one hour of combing, analyzed separately
11296930|NCT02997904|OG003|Outcome|Number of Eggs Removed by Control|Total number of eggs removed after one hour of combing by control, analyzed separately
11296931|NCT02997904|EG000|Reported Event|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296932|NCT02997904|EG001|Reported Event|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour~Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
11296933|NCT02998021|BG000|Baseline|Resistance Training - Vibrating Dumbbell|"Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.~Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators."
11296934|NCT02998021|BG001|Baseline|Resistance Training - Standard Dumbbell|"Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.~Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.~The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.~To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training."
11296935|NCT02998021|BG002|Baseline|Total|Total of all reporting groups
11296936|NCT02998021|FG000|Participant Flow|Resistance Training - Vibrating Dumbbell|"Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.~Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators."
11296937|NCT02998021|FG001|Participant Flow|Resistance Training - Standard Dumbbell|"Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.~Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.~The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.~To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training."
11296938|NCT02998021|OG000|Outcome|Resistance Training - Vibrating Dumbbell|"Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.~Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators."
11296939|NCT02998021|OG001|Outcome|Resistance Training - Standard Dumbbell|"Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.~Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.~The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.~To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training."
10822234|NCT00075478|EG000|Reported Event|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
11332702|NCT03500211|FG001|Participant Flow|Sham Topical Patch|"Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Sham Topical Patch: Sham patch after cesarean section delivery."
11296940|NCT02998021|EG000|Reported Event|Resistance Training - Vibrating Dumbbell|"Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.~Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators."
11296941|NCT02998021|EG001|Reported Event|Resistance Training - Standard Dumbbell|"Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.~Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.~The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.~To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training."
11296942|NCT02998151|BG000|Baseline|All Study Participants|Participants received, in random order, a single dose of placebo, acamprosate, lovastatin, minocycline, or baclofen, with a two-week washout period between doses. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this intervention was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen or a second round of placebo, so investigators and participants would remain blinded to drug status during the baclofen visit. The second round of placebo was not analyzed.
11296943|NCT02998151|FG000|Participant Flow|All Study Participants|This study was designed as a 4-intervention crossover, with all study participants receiving all possible interventions. These were originally placebo, acamprosate, minocycline, and lovastatin. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this arm was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen.
11296944|NCT02998151|OG000|Outcome|Placebo|Placebo: placebo pill
11296945|NCT02998151|OG001|Outcome|Acamprosate|Acamprosate: two 666mg pills
11296946|NCT02998151|OG002|Outcome|Lovastatin|Lovastatin: two 20mg pills
11296947|NCT02998151|OG003|Outcome|Minocycline|Minocycline: two 135mg pills
11296948|NCT02998151|OG004|Outcome|Baclofen|Baclofen: one 30mg pill
11296949|NCT02998151|EG000|Reported Event|Placebo|Placebo: placebo pill
11296950|NCT02998151|EG001|Reported Event|Acamprosate|Acamprosate: two 666mg pills
11296951|NCT02998151|EG002|Reported Event|Lovastatin|Lovastatin: two 20mg pills
11296952|NCT02998151|EG003|Reported Event|Minocycline|Minocycline: two 135mg pills
11296953|NCT02998151|EG004|Reported Event|Baclofen|Baclofen: one 30mg pill
11296954|NCT02998541|BG000|Baseline|SHP640|Participants administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
10842974|NCT00251004|OG002|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11296955|NCT02998541|BG001|Baseline|PVP-I 0.6%|Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
11296956|NCT02998541|BG002|Baseline|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296957|NCT02998541|BG003|Baseline|Total|Total of all reporting groups
11296958|NCT02998541|FG000|Participant Flow|SHP640|Participants administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296959|NCT02998541|FG001|Participant Flow|PVP-I 0.6%|Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
11296960|NCT02998541|FG002|Participant Flow|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296961|NCT02998541|OG000|Outcome|SHP640|Participants administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296962|NCT02998541|OG001|Outcome|PVP-I 0.6%|Participants administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
11296963|NCT02998541|OG002|Outcome|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296964|NCT02998541|EG000|Reported Event|SHP640|Participants received one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296965|NCT02998541|EG001|Reported Event|PVP-I 0.6%|Participants received one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
11296966|NCT02998541|EG002|Reported Event|Placebo|Participants received one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
11296967|NCT02998554|BG000|Baseline|SHP640|Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296968|NCT02998554|BG001|Baseline|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296969|NCT02998554|BG002|Baseline|Total|Total of all reporting groups
11296970|NCT02998554|FG000|Participant Flow|SHP640|Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296971|NCT02998554|FG001|Participant Flow|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296972|NCT02998554|OG000|Outcome|SHP640|Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296973|NCT02998554|OG001|Outcome|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296974|NCT02998554|OG000|Outcome|SHP640|Participants received 1 drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
11296975|NCT02998554|OG001|Outcome|Placebo|Participants received 1 drop of placebo matched to SHP640 ophthalmic solution in each eye QID for 7 days.
11296976|NCT02998554|EG000|Reported Event|SHP640|Participants administered one drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
11296977|NCT02998554|EG001|Reported Event|Placebo|Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
11296978|NCT02998671|BG000|Baseline|P1: CJM112 High Dose / P2: CJM112 High Dose|CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
11296979|NCT02998671|BG001|Baseline|P1: CJM112 Low Dose / P2: CJM112 Low Dose|CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
11296980|NCT02998671|BG002|Baseline|P1: Placebo / P2: CJM112 High Dose|Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
11296981|NCT02998671|BG003|Baseline|P1: Placebo / P2: CJM112 Low Dose|Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
11296982|NCT02998671|BG004|Baseline|P1: Placebo / P2: NA|Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
11296983|NCT02998671|BG005|Baseline|Total|Total of all reporting groups
11296984|NCT02998671|FG000|Participant Flow|P1: CJM112 High Dose / P2: CJM112 High Dose|CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
11296985|NCT02998671|FG001|Participant Flow|P1: CJM112 Low Dose / P2: CJM112 Low Dose|CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
10848314|NCT00289458|EG002|Reported Event|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
11296986|NCT02998671|FG002|Participant Flow|P1: Placebo / P2: CJM112 High Dose|Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
11296987|NCT02998671|FG003|Participant Flow|P1: Placebo / P2: CJM112 Low Dose|Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
11296988|NCT02998671|FG004|Participant Flow|P1: Placebo / P2: NA|Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
11296989|NCT02998671|OG000|Outcome|P1: CJM112 High Dose / P2: CJM112 High Dose|CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
11296990|NCT02998671|OG001|Outcome|P1: CJM112 Low Dose / P2: CJM112 Low Dose|CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
11296991|NCT02998671|OG002|Outcome|P1: Placebo / P2 CJM112 Low Dose or High Dose|Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
11296992|NCT02998671|OG002|Outcome|P1: Placebo / P2: CJM112 High Dose|Placebo in treatment period 1; CJM112 high dose in extension period 2
11296993|NCT02998671|OG003|Outcome|P1: Placebo / P2: CJM112 Low Dose|Placebo in treatment period 1; CJM112 low dose in extension period 2
11296994|NCT02998671|OG002|Outcome|P1: Placebo / P2: CJM112 High Dose|Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
10848315|NCT00289471|BG000|Baseline|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
10848316|NCT00289471|FG000|Participant Flow|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
11296995|NCT02998671|OG003|Outcome|P1: Placebo / P2: CJM112 Low Dose|Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
11296996|NCT02998671|OG004|Outcome|P1: Placebo / P2: NA|Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
11296997|NCT02998671|EG000|Reported Event|Period 1: CJM112 High Dose|Period 1: CJM112 high dose
11296998|NCT02998671|EG001|Reported Event|Period 1: CJM112 Low Dose|Period 1: CJM112 low dose
11296999|NCT02998671|EG002|Reported Event|Period 1: Placebo|Period 1: Placebo
11297000|NCT02998671|EG003|Reported Event|Period 1: Pooled CJM112|Period 1: Pooled CJM112
11297001|NCT02998671|EG004|Reported Event|Period 2: CJM112 High Dose/CJM112 High Dose|CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
11297002|NCT02998671|EG005|Reported Event|Period 2: CJM112 Low Dose/CJM112 Low Dose|CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
11297003|NCT02998671|EG006|Reported Event|Period 2: Placebo/ CJM112 High Dose|Placebo in treatment period 1; CJM112 high dose in extension period 2
11297004|NCT02998671|EG007|Reported Event|Period 2: Placebo/ CJM112 Low Dose|Placebo in treatment period 1; CJM112 low dose in extension period 2
11297005|NCT02998671|EG008|Reported Event|Period 2: Pooled CJM112 High Dose|Period 2: Pooled CJM112 high dose
11297006|NCT02998671|EG009|Reported Event|Period 2: Pooled CJM112 Low Dose|Period 2: Pooled CJM112 low dose
11297007|NCT02998684|BG000|Baseline|Active Transcranial Direct Current Stimulation|"Participants will receive active Transcranial Direct Current Stimulation~Active Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297008|NCT02998684|BG001|Baseline|Sham Transcranial Direct Current Stimulation|"Participants will receive sham Transcranial Direct Current Stimulation~Sham Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297009|NCT02998684|BG002|Baseline|Total|Total of all reporting groups
11297010|NCT02998684|FG000|Participant Flow|Active Transcranial Direct Current Stimulation|"Participants will receive active Transcranial Direct Current Stimulation~Active Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297011|NCT02998684|FG001|Participant Flow|Sham Transcranial Direct Current Stimulation|"Participants will receive sham Transcranial Direct Current Stimulation~Sham Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
10822235|NCT00075478|EG001|Reported Event|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
10822236|NCT00075504|BG000|Baseline|Stratum A Normal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822237|NCT00075504|BG001|Baseline|Stratum B Abnormal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822238|NCT00075504|BG002|Baseline|Total|Total of all reporting groups
10822239|NCT00075504|FG000|Participant Flow|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822240|NCT00075504|FG001|Participant Flow|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822241|NCT00075504|OG000|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822242|NCT00075504|OG001|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822243|NCT00075504|EG000|Reported Event|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822244|NCT00075504|EG001|Reported Event|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
10822245|NCT00075582|BG000|Baseline|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10822246|NCT00075582|BG001|Baseline|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10822247|NCT00075582|BG002|Baseline|Total|Total of all reporting groups
10822248|NCT00075582|FG000|Participant Flow|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10848317|NCT00289471|OG000|Outcome|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
10848318|NCT00289471|EG000|Reported Event|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
11297012|NCT02998684|OG000|Outcome|Active Transcranial Direct Current Stimulation|"Participants will receive active Transcranial Direct Current Stimulation~Active Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297013|NCT02998684|OG001|Outcome|Sham Transcranial Direct Current Stimulation|"Participants will receive sham Transcranial Direct Current Stimulation~Sham Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297014|NCT02998684|EG000|Reported Event|Active Transcranial Direct Current Stimulation|"Participants will receive active Transcranial Direct Current Stimulation~Active Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297015|NCT02998684|EG001|Reported Event|Sham Transcranial Direct Current Stimulation|"Participants will receive sham Transcranial Direct Current Stimulation~Sham Transcranial Direct Current Stimulation~PEERS Social Skills Training: 14 weekly social skills training sessions for all participants"
11297016|NCT02998996|BG000|Baseline|Immunose™ FLU 1%,|"15 µg haemagglutinin(HA)/strain and 1% Endocine™~15 µg HA/strain and 1% Endocine™: intranasal administration"
11297017|NCT02998996|BG001|Baseline|Immunose™ FLU 2%,|"15 µg HA/strain and 2% Endocine™~15 µg HA/strain and 2% Endocine™: intranasal administration"
11297018|NCT02998996|BG002|Baseline|Influenza Antigen,|"15 µg HA/strain~15 µg HA/strain: intranasal administration"
11297019|NCT02998996|BG003|Baseline|Saline (NaCl),|"Placebo~Placebo, Saline: intranasal administration"
11297020|NCT02998996|BG004|Baseline|i.m. Comparator,|"15 µg HA/strain~intramuscular comparator: intramuscular administration"
11297021|NCT02998996|BG005|Baseline|i.n. Comparator|intranasal comparator: intranasal administration
11297022|NCT02998996|BG006|Baseline|Total|Total of all reporting groups
11297023|NCT02998996|FG000|Participant Flow|Immunose™ FLU 1%,|"15 µg haemagglutinin(HA)/strain and 1% Endocine™~15 µg HA/strain and 1% Endocine™: intranasal administration"
11297024|NCT02998996|FG001|Participant Flow|Immunose™ FLU 2%,|"15 µg HA/strain and 2% Endocine™~15 µg HA/strain and 2% Endocine™: intranasal administration"
11297025|NCT02998996|FG002|Participant Flow|Influenza Antigen,|"15 µg HA/strain~15 µg HA/strain: intranasal administration"
11297026|NCT02998996|FG003|Participant Flow|Saline (NaCl),|"Placebo~Placebo, Saline: intranasal administration"
11297027|NCT02998996|FG004|Participant Flow|i.m. Comparator,|"15 µg HA/strain~intramuscular comparator: intramuscular administration"
11297028|NCT02998996|FG005|Participant Flow|i.n. Comparator|intranasal comparator: intranasal administration
10842975|NCT00251004|EG000|Reported Event|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11297029|NCT02998996|OG000|Outcome|Immunose™ FLU 1%,|"15 µg haemagglutinin(HA)/strain and 1% Endocine™~15 µg HA/strain and 1% Endocine™: intranasal administration"
11297030|NCT02998996|OG001|Outcome|Immunose™ FLU 2%,|"15 µg HA/strain and 2% Endocine™~15 µg HA/strain and 2% Endocine™: intranasal administration"
11297031|NCT02998996|OG002|Outcome|Influenza Antigen,|"15 µg HA/strain~15 µg HA/strain: intranasal administration"
11297032|NCT02998996|OG003|Outcome|Saline (NaCl),|"Placebo~Placebo, Saline: intranasal administration"
11297033|NCT02998996|OG004|Outcome|i.m. Comparator,|"15 µg HA/strain~intramuscular comparator: intramuscular administration"
11297034|NCT02998996|OG005|Outcome|i.n. Comparator|intranasal comparator: intranasal administration
11297035|NCT02998996|EG000|Reported Event|Immunose™ FLU 1%,|"15 µg haemagglutinin(HA)/strain and 1% Endocine™~15 µg HA/strain and 1% Endocine™: intranasal administration"
11297036|NCT02998996|EG001|Reported Event|Immunose™ FLU 2%,|"15 µg HA/strain and 2% Endocine™~15 µg HA/strain and 2% Endocine™: intranasal administration"
11297037|NCT02998996|EG002|Reported Event|Influenza Antigen,|"15 µg HA/strain~15 µg HA/strain: intranasal administration"
11297038|NCT02998996|EG003|Reported Event|Saline (NaCl),|"Placebo~Placebo, Saline: intranasal administration"
11297039|NCT02998996|EG004|Reported Event|i.m. Comparator,|"15 µg HA/strain~intramuscular comparator: intramuscular administration"
11297040|NCT02998996|EG005|Reported Event|i.n. Comparator|intranasal comparator: intranasal administration
11297041|NCT02999100|BG000|Baseline|400 mcg Oxytocin IH|Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297042|NCT02999100|BG001|Baseline|17 mcg Oxytocin IM|Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297043|NCT02999100|BG002|Baseline|Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV|Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297044|NCT02999100|BG003|Baseline|Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH|Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297045|NCT02999100|BG004|Baseline|400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV|Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11217040|NCT02310750|OG006|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217041|NCT02310750|OG007|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
10848319|NCT00289536|BG000|Baseline|Treated Participants|Participants who received at least 1 infusion of rAHF-PFM.
10848320|NCT00289536|FG000|Participant Flow|Low Dose|15 IU/kg rAHF-PFM
10848321|NCT00289536|FG001|Participant Flow|Medium Dose|30 IU/kg rAHF-PFM
11217042|NCT02310750|OG008|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217043|NCT02310750|OG009|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
10848322|NCT00289536|FG002|Participant Flow|High Dose|50 IU/kg rAHF-PFM
10848323|NCT00289536|OG000|Outcome|Low Dose|15 IU/kg rAHF-PFM
11217044|NCT02310750|OG010|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217045|NCT02310750|OG011|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
10848324|NCT00289536|OG001|Outcome|Medium Dose|30 IU/kg rAHF-PFM
10848325|NCT00289536|OG002|Outcome|High Dose|50 IU/kg rAHF-PFM
10848326|NCT00289536|EG000|Reported Event|Safety Population (26 Participants)|Participants who received at least 1 infusion of rAHF-PFM
10848327|NCT00289653|BG000|Baseline|Enrolled Participants|All eligible enrolled participants
10848328|NCT00289653|FG000|Participant Flow|Nicotine Therapy + Counselling|Nicotine replacement therapy + brief counselling
10848329|NCT00289653|OG000|Outcome|Enrolled Participants|12 participants who completed the study
10848330|NCT00289653|OG000|Outcome|Enrolled Participants|participants who completed the study
10848331|NCT00289653|EG000|Reported Event|Enrolled Participants|participants who enrolled in the study
10848332|NCT00289718|BG000|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
11217046|NCT02310750|OG012|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217047|NCT02310750|OG000|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217048|NCT02310750|OG001|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217049|NCT02310750|OG002|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217050|NCT02310750|OG003|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217051|NCT02310750|OG004|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217052|NCT02310750|OG005|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217053|NCT02310750|OG006|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217054|NCT02310750|OG013|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217055|NCT02310750|OG014|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217056|NCT02310750|OG015|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217057|NCT02310750|EG000|Reported Event|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217058|NCT02310750|EG001|Reported Event|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
11217059|NCT02310750|EG002|Reported Event|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217060|NCT02310750|EG003|Reported Event|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217061|NCT02310750|EG004|Reported Event|PF--06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217062|NCT02310750|EG005|Reported Event|PF--06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11297046|NCT02999100|BG005|Baseline|8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH|Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297047|NCT02999100|BG006|Baseline|Total|Total of all reporting groups
11297048|NCT02999100|FG000|Participant Flow|400 mcg Oxytocin IH|Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297049|NCT02999100|FG001|Participant Flow|17 mcg Oxytocin IM|Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297050|NCT02999100|FG002|Participant Flow|Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV|Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297051|NCT02999100|FG003|Participant Flow|Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH|Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297052|NCT02999100|FG004|Participant Flow|400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV|Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297053|NCT02999100|FG005|Participant Flow|8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH|Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
11297054|NCT02999100|OG000|Outcome|400 mcg Oxytocin IH|Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297055|NCT02999100|OG001|Outcome|17 mcg Oxytocin IM|Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297056|NCT02999100|OG000|Outcome|Combined Oral Contraceptives+400 mcg Oxytocin IH|Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.
11297057|NCT02999100|OG001|Outcome|Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297058|NCT02999100|OG002|Outcome|Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.
11297059|NCT02999100|OG003|Outcome|Non-Combined Oral Contraceptives+400 mcg Oxytocin IH|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.
11297060|NCT02999100|OG004|Outcome|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297061|NCT02999100|OG005|Outcome|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
11297062|NCT02999100|OG000|Outcome|Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297063|NCT02999100|OG001|Outcome|Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.
11297064|NCT02999100|OG002|Outcome|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297065|NCT02999100|OG003|Outcome|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
11297066|NCT02999100|EG000|Reported Event|400 mcg Oxytocin IH|Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297067|NCT02999100|EG001|Reported Event|17 mcg Oxytocin IM|Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.
11297068|NCT02999100|EG002|Reported Event|Combined Oral Contraceptives+400 mcg Oxytocin IH|Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH
11297069|NCT02999100|EG003|Reported Event|Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297070|NCT02999100|EG004|Reported Event|Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.
11297071|NCT02999100|EG005|Reported Event|Non-Combined Oral Contraceptives+400 mcg Oxytocin IH|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.
11297072|NCT02999100|EG006|Reported Event|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.
11297073|NCT02999100|EG007|Reported Event|Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion|Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
11297074|NCT02999178|BG000|Baseline|150 mg Nintedanib|150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297075|NCT02999178|BG001|Baseline|Placebo|150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297076|NCT02999178|BG002|Baseline|Total|Total of all reporting groups
11297077|NCT02999178|FG000|Participant Flow|150 mg Nintedanib|150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297078|NCT02999178|FG001|Participant Flow|Placebo|150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297079|NCT02999178|OG000|Outcome|150 mg Nintedanib|150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297080|NCT02999178|OG001|Outcome|Placebo|150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297081|NCT02999178|EG000|Reported Event|Nintedanib|150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297082|NCT02999178|EG001|Reported Event|Placebo|150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).
11297083|NCT02999191|BG000|Baseline|BI 1467335: Tablets, Fasted/Solution, Fasted/Tablets, Fed|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 1, followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10 hours [h] [Treatment B] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11297084|NCT02999191|BG001|Baseline|BI 1467335: Solution, Fasted/Tablets, Fed/Tablets, Fasted|The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast at least 10h [Treatment B] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state [Treatment A] orally with 240 mL of water after an overnight fast of at least 10h in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11332703|NCT03500211|OG000|Outcome|Lidoderm 5% Topical Patch|"5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery."
11297085|NCT02999191|BG002|Baseline|BI 1467335: Tablets, Fed/Tablets, Fasted/Solution, Fasted|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 2, then followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h [Treatment B] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11297086|NCT02999191|BG003|Baseline|Total|Total of all reporting groups
11297087|NCT02999191|FG000|Participant Flow|BI 1467335: Tablets, Fasted/Solution, Fasted/Tablets, Fed|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 1, followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10 hours [h] [Treatment B] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11297088|NCT02999191|FG001|Participant Flow|BI 1467335: Solution, Fasted/Tablets, Fed/Tablets, Fasted|The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast at least 10h [Treatment B] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 2, then followed by BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state [Treatment A] orally with 240 mL of water after an overnight fast of at least 10h in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11297089|NCT02999191|FG002|Participant Flow|BI 1467335: Tablets, Fed/Tablets, Fasted/Solution, Fasted|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state [Treatment C] in period 1, followed by BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fasted state [Treatment A] in period 2, then followed by BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h [Treatment B] in period 3. The treatment duration was one day for each treatment [3 single doses], separated by washout phases of at least 21 days.
11297090|NCT02999191|OG000|Outcome|BI 1467335: Tablets, Fed|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state. The treatment duration was one day.
11297091|NCT02999191|OG001|Outcome|BI 1467335: Tablets, Fasted|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day.
11297092|NCT02999191|OG002|Outcome|BI 1467335: Solution, Fasted|The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day.
11297093|NCT02999191|EG000|Reported Event|BI 1467335: Tablets, Fasted|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day.
11297094|NCT02999191|EG001|Reported Event|BI 1467335: Solution, Fasted|The subjects were administered BI 1467335 10 mg oral solution in the fasted state orally with 240 mL of water after an overnight fast of at least 10h. The treatment duration was one day
11297095|NCT02999191|EG002|Reported Event|BI 1467335: Tablets, Fed|The subjects were administered BI 1467335 10 mg [2*5 mg] film-coated tablets orally in the fed state. The treatment duration was one day.
11297096|NCT02999672|BG000|Baseline|Cohort 1 (UBC)|First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
10848333|NCT00289718|FG000|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
11297097|NCT02999672|BG001|Baseline|Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma)|First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297098|NCT02999672|BG002|Baseline|Total|Total of all reporting groups
11297099|NCT02999672|FG000|Participant Flow|Cohort 1 (UBC)|First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297100|NCT02999672|FG001|Participant Flow|Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma)|First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297101|NCT02999672|OG000|Outcome|Cohort 1 (UBC)|First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297102|NCT02999672|OG001|Outcome|Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma)|First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297103|NCT02999672|EG000|Reported Event|Cohort 1 (UBC)|First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297104|NCT02999672|EG001|Reported Event|Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma)|First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
11297105|NCT02999763|BG000|Baseline|Treated and Untreated Abdomen|Circumference and fat thickness measurements of abdomen before after SlimShape treatments of the same subjects
11297106|NCT02999763|FG000|Participant Flow|Treated and Untreated Abdomen|Circumference and fat thickness reduction of abdomen after SlimShape treatments (three treatments with SlimShape RF based device)
11297107|NCT02999763|OG000|Outcome|Treated Abdomen|Subjects treated on the abdomen with SlimShape RF treatments
11297108|NCT02999763|EG000|Reported Event|Treated Abdomen|Subjects treated on the abdomen with SlimShape RF treatments
11297109|NCT03000010|BG000|Baseline|Incisional Wound Vac|"We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.~Incisional Wound Vac"
10848334|NCT00289718|OG000|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups~(lot A, B or C) were pooled into the Twinrix Group for data analyses during~the long term follow-up"
11297110|NCT03000010|BG001|Baseline|Normal Gauze Bandage Group|"We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.~Standard Bandage"
11297111|NCT03000010|BG002|Baseline|Total|Total of all reporting groups
11297112|NCT03000010|FG000|Participant Flow|Incisional Wound Vac|"We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.~Incisional Wound Vac"
11297113|NCT03000010|FG001|Participant Flow|Normal Gauze Bandage Group|"We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.~Standard Bandage"
11297114|NCT03000010|OG000|Outcome|Incisional Wound Vac|"We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.~Incisional Wound Vac"
11297115|NCT03000010|OG001|Outcome|Normal Gauze Bandage Group|"We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.~Standard Bandage"
11297116|NCT03000010|EG000|Reported Event|Incisional Wound Vac|"We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.~Incisional Wound Vac"
11297117|NCT03000010|EG001|Reported Event|Normal Gauze Bandage Group|"We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.~Standard Bandage"
11297118|NCT03000075|BG000|Baseline|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297119|NCT03000075|BG001|Baseline|Risankizumab 75 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297120|NCT03000075|BG002|Baseline|Risankizumab 150 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297121|NCT03000075|BG003|Baseline|Total|Total of all reporting groups
11297122|NCT03000075|FG000|Participant Flow|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297123|NCT03000075|FG001|Participant Flow|Risankizumab 75 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297124|NCT03000075|FG002|Participant Flow|Risankizumab 150 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297125|NCT03000075|FG003|Participant Flow|Placebo/Risankizumab 75 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297126|NCT03000075|FG004|Participant Flow|Placebo/Risankizumab 150 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297127|NCT03000075|FG005|Participant Flow|Risankizumab 75 mg/Risankizumab 75 mg (Part B)|Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
10971354|NCT00915343|BG000|Baseline|Entire Study|Included all participants randomized to receive hydrocortisone MR tablets orally OD first or hydrocortisone tablets orally TID first; in any of the intervention periods during the 12-week cross-over period of Part A or hydrocortisone MR tablets orally OD during the 6-month open-label period of Part B.
10971355|NCT00915343|FG000|Participant Flow|Hydrocortisone MR OD Then Hydrocortisone TID - Part A|Participants received novel once daily (OD) hydrocortisone modified release (MR) tablets in the first intervention period then hydrocortisone tablets thrice daily (TID) in the second intervention period, at the same total daily dose of 20 to 40 milligram (mg) for 12 weeks.
10971356|NCT00915343|FG001|Participant Flow|Hydrocortisone TID Then Hydrocortisone MR OD - Part A|Participants received hydrocortisone tablets TID in the first intervention period then novel OD hydrocortisone MR tablets in the second intervention period, at the same total daily dose of 20 to 40 mg for 12 weeks.
11297128|NCT03000075|FG006|Participant Flow|Risankizumab150 mg /Risankizumab 150 mg (Part B)|Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297129|NCT03000075|OG000|Outcome|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297130|NCT03000075|OG001|Outcome|Risankizumab 75 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297131|NCT03000075|OG002|Outcome|Risankizumab 150 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297132|NCT03000075|OG000|Outcome|Placebo/Risankizumab 75 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297133|NCT03000075|OG001|Outcome|Placebo/Risankizumab 150 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297134|NCT03000075|OG002|Outcome|Risankizumab 75 mg/Risankizumab 75 mg (Part B)|Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297135|NCT03000075|OG003|Outcome|Risankizumab150 mg /Risankizumab 150 mg (Part B)|Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297136|NCT03000075|EG000|Reported Event|Placebo (Part A)|Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297137|NCT03000075|EG001|Reported Event|Risankizumab 75 mg (Part A)|Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297138|NCT03000075|EG002|Reported Event|Risankizumab 150 mg (Part A)|): Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
11297139|NCT03000075|EG003|Reported Event|Placebo/Risankizumab 75 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297140|NCT03000075|EG004|Reported Event|Placebo/Risankizumab 150 mg (Part B)|Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297141|NCT03000075|EG005|Reported Event|Risankizumab 75 mg/Risankizumab 75 mg (Part B)|Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297142|NCT03000075|EG006|Reported Event|Risankizumab 150 mg/Risankizumab 150 mg (Part B)|Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
11297143|NCT03000088|BG000|Baseline|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
11297144|NCT03000088|BG001|Baseline|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
10971357|NCT00915343|FG002|Participant Flow|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD for 6 months.
10971358|NCT00915343|OG000|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
10971359|NCT00915343|OG001|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
10971360|NCT00915343|OG000|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
11297145|NCT03000088|BG002|Baseline|Total|Total of all reporting groups
11297146|NCT03000088|FG000|Participant Flow|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
11297147|NCT03000088|FG001|Participant Flow|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
11297148|NCT03000088|OG000|Outcome|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
11297149|NCT03000088|OG001|Outcome|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
11297150|NCT03000088|EG000|Reported Event|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
11297151|NCT03000088|EG001|Reported Event|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
11297152|NCT03000166|BG000|Baseline|Step-Up Intervention Group|"Participants assigned to the Step-Up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.~Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker."
11297153|NCT03000166|BG001|Baseline|Attention Control Group|Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
11297154|NCT03000166|BG002|Baseline|Total|Total of all reporting groups
11297155|NCT03000166|FG000|Participant Flow|Step-up Intervention Group|"Participants assigned to the intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.~Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker."
11297156|NCT03000166|FG001|Participant Flow|Attention Control Group|Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
11297157|NCT03000166|OG000|Outcome|Step-Up Intervention Group|"Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.~Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker."
11297158|NCT03000166|OG001|Outcome|Attention Control Group|Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
11297159|NCT03000166|OG000|Outcome|Step-up Intervention Group|"Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.~Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker."
11297160|NCT03000166|EG000|Reported Event|Step-up Intervention Group|"Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.~Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker."
11297161|NCT03000166|EG001|Reported Event|Attention Control Group|Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
11297162|NCT03000283|BG000|Baseline|Conivaptan Treatment Group|"All seven patients in this arm will receive conivaptan as described in Interventions.~Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.~The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line."
11297163|NCT03000283|FG000|Participant Flow|Conivaptan Treatment Group|"All seven patients in this arm will receive conivaptan as described in Interventions.~Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.~The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line."
11297164|NCT03000283|OG000|Outcome|Conivaptan Treatment Group|"All seven patients in this arm will receive conivaptan as described in Interventions.~Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.~The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line."
11297165|NCT03000283|EG000|Reported Event|Conivaptan Treatment Group|"All seven patients in this arm will receive conivaptan as described in Interventions.~Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.~The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line."
11297166|NCT03000309|BG000|Baseline|Apremilast|"Apremilast, 30 mg. tablets, two times a day for 16 weeks~Apremilast"
11297167|NCT03000309|FG000|Participant Flow|Apremilast|"Apremilast, 30 mg. tablets, two times a day for 16 weeks~Apremilast"
11297168|NCT03000309|OG000|Outcome|Apremilast|"Apremilast, 30 mg. tablets, two times a day for 16 weeks~Apremilast"
11217063|NCT02310750|EG006|Reported Event|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
10848335|NCT00289718|OG000|Outcome|Twinrix Group|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
11217064|NCT02310750|EG007|Reported Event|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217065|NCT02310750|EG008|Reported Event|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217066|NCT02310750|EG009|Reported Event|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217067|NCT02310750|EG010|Reported Event|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217068|NCT02310750|EG011|Reported Event|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217069|NCT02310750|EG012|Reported Event|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
11217070|NCT02310750|EG013|Reported Event|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
11217071|NCT02310750|EG014|Reported Event|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
11217072|NCT02310750|EG015|Reported Event|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217073|NCT02310750|EG016|Reported Event|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
11217074|NCT02310750|EG017|Reported Event|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217075|NCT02310750|EG018|Reported Event|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217076|NCT02310750|EG019|Reported Event|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
11217077|NCT02310763|BG000|Baseline|Sequence 1|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants continued to receive domagrozumab at the maximum tolerated dose (40 mg/kg) every 4 weeks for additional 48 weeks or until early termination of the study.
11217078|NCT02310763|BG001|Baseline|Sequence 2|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants received placebo for additional 48 weeks or until early termination of the study.
11217079|NCT02310763|BG002|Baseline|Sequence 3|Participants in this sequence received placebo for 48 weeks (Period 1). From Week 49 (Period 2), participants received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for additional 48 weeks or until early termination of the study. At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses).
11217080|NCT02310763|BG003|Baseline|Total|Total of all reporting groups
11217081|NCT02310763|FG000|Participant Flow|Sequence 1|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants continued to receive domagrozumab at the maximum tolerated dose (40 mg/kg) every 4 weeks for additional 48 weeks or until early termination of the study.
11217082|NCT02310763|FG001|Participant Flow|Sequence 2|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants received placebo for additional 48 weeks or until early termination of the study.
11217083|NCT02310763|FG002|Participant Flow|Sequence 3|Participants in this sequence received placebo for 48 weeks (Period 1). From Week 49 (Period 2), participants received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for additional 48 weeks or until early termination of the study. At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses).
11217084|NCT02310763|OG000|Outcome|Placebo|Participants received placebo from Week 1 to Week 48.
11217085|NCT02310763|OG001|Outcome|Domagrozumab 5 mg/kg|Participants received domagrozumab at a dose of 5 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 1 to Week 16 (4 doses).
11217086|NCT02310763|OG002|Outcome|Domagrozumab 20 mg/kg|Participants received domagrozumab at a dose of 20 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 17 to Week 32 (4 doses).
11217087|NCT02310763|OG003|Outcome|Domagrozumab 40 mg/kg|Participants received domagrozumab at a dose of 40 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 33 to Week 48 (4 doses).
11297169|NCT03000309|EG000|Reported Event|Apremilast|"Apremilast, 30 mg. tablets, two times a day for 16 weeks~Apremilast"
11297170|NCT03000348|BG000|Baseline|Placebo|"Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.~Placebo Oral Capsule: Placebo Oral Capsule"
11297171|NCT03000348|BG001|Baseline|450mg, Once Per Day|"Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297172|NCT03000348|BG002|Baseline|150mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297173|NCT03000348|BG003|Baseline|450mg, Twice Per Day|"Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297174|NCT03000348|BG004|Baseline|300mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297175|NCT03000348|BG005|Baseline|450mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297176|NCT03000348|BG006|Baseline|Total|Total of all reporting groups
11297177|NCT03000348|FG000|Participant Flow|Placebo|"Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.~Placebo Oral Capsule: Placebo Oral Capsule"
11297178|NCT03000348|FG001|Participant Flow|450mg, Once Per Day|"Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297179|NCT03000348|FG002|Participant Flow|150mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297180|NCT03000348|FG003|Participant Flow|450mg, Twice Per Day|"Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297181|NCT03000348|FG004|Participant Flow|300mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297182|NCT03000348|FG005|Participant Flow|450mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297183|NCT03000348|OG000|Outcome|Placebo|"Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.~Placebo Oral Capsule: Placebo Oral Capsule"
11297184|NCT03000348|OG001|Outcome|450mg, Once Per Day|"Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297185|NCT03000348|OG002|Outcome|150mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297186|NCT03000348|OG003|Outcome|450mg, Twice Per Day|"Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297187|NCT03000348|OG004|Outcome|300mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297188|NCT03000348|OG005|Outcome|High Dose, Three Times Per Day|"Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297189|NCT03000348|OG002|Outcome|150mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
10842976|NCT00251004|EG001|Reported Event|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11297190|NCT03000348|OG005|Outcome|450mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297191|NCT03000348|OG005|Outcome|450mg, Three Times Per Day|"Patient takes three oral doses of Cysteamine 450mg) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297192|NCT03000348|EG000|Reported Event|Placebo|"Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.~Placebo Oral Capsule: Placebo Oral Capsule"
11297193|NCT03000348|EG001|Reported Event|High Dose, Once Per Day|"Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297194|NCT03000348|EG002|Reported Event|Low Dose, Three Times Per Day|"Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297195|NCT03000348|EG003|Reported Event|High Dose, Twice Per Day|"Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297196|NCT03000348|EG004|Reported Event|Mid-Range Dose, Three Times Per Day|"Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule~Placebo Oral Capsule: Placebo Oral Capsule"
11297197|NCT03000348|EG005|Reported Event|High Dose, Three Times Per Day|"Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.~Cysteamine: Oral Cysteamine Capsule"
11297198|NCT03000452|BG000|Baseline|Daratumumab and Durvalumab|Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
11297199|NCT03000452|FG000|Participant Flow|Daratumumab and Durvalumab|Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
11297200|NCT03000452|OG000|Outcome|Daratumumab and Durvalumab|Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
11297201|NCT03000452|EG000|Reported Event|Daratumumab and Durvalumab|Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
11297202|NCT03000608|BG000|Baseline|SAN021 Serum|"SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297203|NCT03000608|BG001|Baseline|SAN021 Placebo|"SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297204|NCT03000608|BG002|Baseline|Total|Total of all reporting groups
10848336|NCT00289718|OG000|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
11297205|NCT03000608|FG000|Participant Flow|SAN021 Serum|"SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297206|NCT03000608|FG001|Participant Flow|SAN021 Placebo|"SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297207|NCT03000608|OG000|Outcome|SAN021 Serum|"SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297208|NCT03000608|OG001|Outcome|SAN021 Placebo|"SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
10848337|NCT00289718|OG000|Outcome|TWINRIX GROUP|Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up
11297209|NCT03000608|EG000|Reported Event|SAN021 Serum|"SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Serum: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297210|NCT03000608|EG001|Reported Event|SAN021 Placebo|"SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.~SAN021 Placebo: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily."
11297211|NCT03000673|BG000|Baseline|Seq ABCD|Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
11297212|NCT03000673|BG001|Baseline|Seq BDAC|Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
11297213|NCT03000673|BG002|Baseline|Seq CADB|Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
11297214|NCT03000673|BG003|Baseline|Seq DCBA|Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
11297215|NCT03000673|BG004|Baseline|Total|Total of all reporting groups
11297216|NCT03000673|FG000|Participant Flow|Sequence ABCD|Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
11297217|NCT03000673|FG001|Participant Flow|Sequence BDAC|Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
11297218|NCT03000673|FG002|Participant Flow|Sequence CADB|Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
11297219|NCT03000673|FG003|Participant Flow|Sequence DCBA|Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
11297220|NCT03000673|OG000|Outcome|Treatment B|Treatment B = BMS-986177 100 mg oral suspension
11297221|NCT03000673|OG001|Outcome|Treatment C|Treatment C = BMS-986177 300 mg oral suspension
11297222|NCT03000673|OG002|Outcome|Treatment D|Treatment D = enoxaparin 40 mg by subcutaneous injection
10848338|NCT00289718|OG000|Outcome|Twinrix Group (Lot A)|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
11297223|NCT03000673|OG003|Outcome|Treatment A|Treatments: A = UFH intravenous infusion
11297224|NCT03000673|OG003|Outcome|Treatment A|Treatment A = UFH intravenous infusion
11297225|NCT03000673|EG000|Reported Event|Treatment A|Treatment A = UFH intravenous infusion;
11297226|NCT03000673|EG001|Reported Event|Treatment B|Treatment B = BMS-986177 100 mg
11297227|NCT03000673|EG002|Reported Event|Treatment C|Treatment C = BMS-986177 300 mg
11297228|NCT03000673|EG003|Reported Event|Treatment D|Treatment D = enoxaparin 40 mg by subcutaneous injection
11297229|NCT03000686|BG000|Baseline|All Participants-Part 1|All participants who were randomized to either of the two treatment sequences Placebo/GSK2586881 or GSK2586881/Placebo and received a single IV dose of GSK2586881 and placebo in either Treatment period 1 or 2 during Part 1 of the study were included. The treatment periods were separated by a wash-out period of 3 to 14 days.
11297230|NCT03000686|BG001|Baseline|All Participants-Part 2|All participants who were randomized to either of the two treatment sequences Placebo/GSK2586881 or GSK2586881/Placebo and received a single IV dose of GSK2586881 and placebo in either Treatment period 1 or 2 during Part 2 of the study were included. The treatment periods were separated by a wash-out period of 3 to 14 days.
11297231|NCT03000686|BG002|Baseline|Total|Total of all reporting groups
11297232|NCT03000686|FG000|Participant Flow|Part 1: Placebo/GSK2586881|Participants were administered a single intravenous (IV) dose of placebo in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of 0.8 milligrams per kilogram (mg/kg) GSK2586881. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum oxygen consumption (VO2) uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297233|NCT03000686|FG001|Participant Flow|Part 1: GSK2586881/Placebo|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of placebo. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297234|NCT03000686|FG002|Participant Flow|Part 2: Placebo/GSK2586881|Participants were administered a single IV dose of placebo in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of 0.8 mg/kg GSK2586881. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297235|NCT03000686|FG003|Participant Flow|Part 2: GSK2586881/Placebo|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of placebo. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297236|NCT03000686|OG000|Outcome|Part 1: Placebo|Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297237|NCT03000686|OG001|Outcome|Part 1: GSK2586881 0.8 mg/kg|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297238|NCT03000686|OG000|Outcome|Part 2: Placebo|Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297239|NCT03000686|OG001|Outcome|Part 2: GSK2586881 0.8 mg/kg|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297240|NCT03000686|OG000|Outcome|Part 1: GSK2586881 0.8 mg/kg|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297241|NCT03000686|OG000|Outcome|Part 2: GSK2586881 0.8 mg/kg|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297242|NCT03000686|EG000|Reported Event|Part 1: Placebo|Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297243|NCT03000686|EG001|Reported Event|Part 1: GSK2586881|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.
11297244|NCT03000686|EG002|Reported Event|Part 2: Placebo|Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297245|NCT03000686|EG003|Reported Event|Part 2: GSK2586881 0.8 mg/kg|Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.
11297246|NCT03001076|BG000|Baseline|Placebo|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297247|NCT03001076|BG001|Baseline|Bempedoic Acid|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297248|NCT03001076|BG002|Baseline|Total|Total of all reporting groups
11297249|NCT03001076|FG000|Participant Flow|Placebo|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297250|NCT03001076|FG001|Participant Flow|Bempedoic Acid|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297251|NCT03001076|OG000|Outcome|Placebo|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297252|NCT03001076|OG001|Outcome|Bempedoic Acid|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297253|NCT03001076|EG000|Reported Event|Placebo|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297254|NCT03001076|EG001|Reported Event|Bempedoic Acid|Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
11297255|NCT03001219|BG000|Baseline|PoC Placebo to Extension Period Analysis RO7123520|In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56. Participants from this group that continued to the Extension Period Analysis period were assigned RO7123520 + pre-trial anti-TNF-alpha and MTX at either 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11297256|NCT03001219|BG001|Baseline|RO70123520 360 or 810 mg/Dose|In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56. Participants continuing to the Extension Period Analysis period received 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11297257|NCT03001219|BG002|Baseline|Total|Total of all reporting groups
11297258|NCT03001219|FG000|Participant Flow|PoC Placebo to Extension Period Analysis RO7123520|In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56. Participants from this group that continued to the Extension Period Analysis period were assigned RO7123520 + pre-trial anti-TNF-alpha and MTX at either 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11297259|NCT03001219|FG001|Participant Flow|RO70123520 360 or 810 mg/Dose|In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56. Participants continuing to the Extension Period Analysis period received 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11297260|NCT03001219|OG000|Outcome|Placebo|In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
11297261|NCT03001219|OG001|Outcome|Proof of Concept: RO7123520 810mg/Dose|In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
11297262|NCT03001219|OG002|Outcome|Extension Period Analysis: RO7123520 360mg/Dose|Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
11297263|NCT03001219|OG003|Outcome|Extension Period Analysis: RO70123520 810mg/Dose|Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11297264|NCT03001219|OG000|Outcome|Proof of Concept: RO7123520 810mg/Dose|In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
11297265|NCT03001219|EG000|Reported Event|Placebo|In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
11297266|NCT03001219|EG001|Reported Event|Proof of Concept: RO7123520 810mg/Dose|In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
11297267|NCT03001219|EG002|Reported Event|Extension Period Analysis: RO7123520 360mg/Dose|Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
11297268|NCT03001219|EG003|Reported Event|Extension Period Analysis: RO70123520 810mg/Dose|Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
11332704|NCT03500211|OG001|Outcome|Sham Topical Patch|"Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Sham Topical Patch: Sham patch after cesarean section delivery."
11297269|NCT03001258|BG000|Baseline|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity.~A total of 40 eye camps were held in two sub districts by eight POs."
11297270|NCT03001258|BG001|Baseline|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity."
11297271|NCT03001258|BG002|Baseline|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297272|NCT03001258|BG003|Baseline|Total|Total of all reporting groups
11297273|NCT03001258|FG000|Participant Flow|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.~A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. A total of 40 eye camps were held in two sub districts by eight POs.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and managemen"
11297274|NCT03001258|FG001|Participant Flow|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as"
11297275|NCT03001258|FG002|Participant Flow|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297276|NCT03001258|OG000|Outcome|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity. A total of 40 eye camps were held in two sub districts by eight POs.
10848339|NCT00289718|OG001|Outcome|Twinrix Group (Lot B)|Subjects who received 2 doses of Twinrix™ (lot B) in the primary study.
11297277|NCT03001258|OG001|Outcome|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297278|NCT03001258|OG002|Outcome|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297279|NCT03001258|EG000|Reported Event|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity A total of 40 eye camps were held in two sub districts by eight POs.
11297280|NCT03001258|EG001|Reported Event|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297281|NCT03001258|EG002|Reported Event|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
11297282|NCT03001453|BG000|Baseline|Liposomal Bupivacaine|"Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine~Liposomal Bupivacaine: 266mg liposomal bupivacaine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine~Saline: Normal saline"
11297283|NCT03001453|BG001|Baseline|Bupivacaine With Epinephrine|"Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine"
11297284|NCT03001453|BG002|Baseline|Total|Total of all reporting groups
11297285|NCT03001453|FG000|Participant Flow|Liposomal Bupivacaine|"Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine~Liposomal Bupivacaine: 266mg liposomal bupivacaine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine~Saline: Normal saline"
11297286|NCT03001453|FG001|Participant Flow|Bupivacaine With Epinephrine|"Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine"
11297287|NCT03001453|OG000|Outcome|Liposomal Bupivacaine|"Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine~Liposomal Bupivacaine: 266mg liposomal bupivacaine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine~Saline: Normal saline"
11297288|NCT03001453|OG001|Outcome|Bupivacaine With Epinephrine|"Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine"
11297289|NCT03001453|EG000|Reported Event|Liposomal Bupivacaine|"Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine~Liposomal Bupivacaine: 266mg liposomal bupivacaine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine~Saline: Normal saline"
11297290|NCT03001453|EG001|Reported Event|Bupivacaine With Epinephrine|"Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine~0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine"
11332705|NCT03500211|EG000|Reported Event|Lidoderm 5% Topical Patch|"5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery."
11332706|NCT03500211|EG001|Reported Event|Sham Topical Patch|"Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.~Sham Topical Patch: Sham patch after cesarean section delivery."
11332707|NCT03500224|BG000|Baseline|[14C]-TAK-954 0.5 mg|[14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
11332708|NCT03500224|FG000|Participant Flow|[14C]-TAK-954 0.5 mg|[14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
11332709|NCT03500224|OG000|Outcome|[14C]-TAK-954 0.5 mg|[14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
11332710|NCT03500224|EG000|Reported Event|[14C]-TAK-954 0.5 mg|[14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
11332711|NCT03500289|BG000|Baseline|Ketamine|Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
11332712|NCT03500289|BG001|Baseline|Midazolam|Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
11332713|NCT03500289|BG002|Baseline|Total|Total of all reporting groups
11332714|NCT03500289|FG000|Participant Flow|Ketamine|Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
11332715|NCT03500289|FG001|Participant Flow|Midazolam|Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
11332716|NCT03500289|OG000|Outcome|Ketamine|Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
11332717|NCT03500289|OG001|Outcome|Midazolam|Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
11332718|NCT03500289|EG000|Reported Event|Ketamine|Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
11332719|NCT03500289|EG001|Reported Event|Midazolam|Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
11332720|NCT03500302|BG000|Baseline|Evolocumab Group|Patients (people living with HIV) who received Evolocumab sq once a month for total of 2 doses
11332721|NCT03500302|FG000|Participant Flow|Evolocumab|All enrolled patients (people living with HIV) who received evolocumab sq once a month for a total of two doses
11332722|NCT03500302|OG000|Outcome|Evolocumab|Patients with HIV receiving Evolocumab sq (2 doses total)
11332723|NCT03500302|EG000|Reported Event|Evolocumab|All enrolled patients who received evolocumab sq once a month for a total of two doses.
11332724|NCT03500419|BG000|Baseline|Control|"No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.~No treatment: Control group. No treatment was given for the 6 months post-prostatectomy"
11332725|NCT03500419|BG001|Baseline|PTT 1-2x Daily x 5-7 Days/Week x 5 Months|"Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.~RestoreX: PTT - Penile traction therapy in the straight position."
11332726|NCT03500419|BG002|Baseline|Total|Total of all reporting groups
11332727|NCT03500419|FG000|Participant Flow|Control|"No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.~No treatment: Control group. No treatment was given for the 6 months post-prostatectomy"
11332728|NCT03500419|FG001|Participant Flow|PTT 1-2x Daily x 5-7 Days/Week x 5 Months|"Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.~RestoreX: PTT - Penile traction therapy in the straight position."
11332729|NCT03500419|OG000|Outcome|Control|"No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.~No treatment: Control group. No treatment was given for the 6 months post-prostatectomy"
11332730|NCT03500419|OG001|Outcome|PTT 1-2x Daily x 5-7 Days/Week x 5 Months|"Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.~RestoreX: PTT - Penile traction therapy in the straight position."
11332731|NCT03500419|EG000|Reported Event|Control|"No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.~No treatment: Control group. No treatment was given for the 6 months post-prostatectomy"
11332732|NCT03500419|EG001|Reported Event|PTT 1-2x Daily x 5-7 Days/Week x 5 Months|"Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.~RestoreX: PTT - Penile traction therapy in the straight position."
11332733|NCT03500679|BG000|Baseline|ExPEC4V|Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
11332734|NCT03500679|BG001|Baseline|Placebo|Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
11332735|NCT03500679|BG002|Baseline|Total|Total of all reporting groups
11332736|NCT03500679|FG000|Participant Flow|ExPEC4V|Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
11332737|NCT03500679|FG001|Participant Flow|Placebo|Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
11297291|NCT03001557|BG000|Baseline|Core Phase: Lemborexant-matched Placebo|Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297292|NCT03001557|BG001|Baseline|Core Phase: Lemborexant 2.5 mg|Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297293|NCT03001557|BG002|Baseline|Core Phase: Lemborexant 5 mg|Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297294|NCT03001557|BG003|Baseline|Core Phase: Lemborexant 10 mg|Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297295|NCT03001557|BG004|Baseline|Core Phase: Lemborexant 15 mg|Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297296|NCT03001557|BG005|Baseline|Total|Total of all reporting groups
11297297|NCT03001557|FG000|Participant Flow|Core Phase: Lemborexant-matched Placebo|Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297298|NCT03001557|FG001|Participant Flow|Core Phase: Lemborexant 2.5 mg|Participants received one lemborexant 2.5 milligrams (mg) and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297299|NCT03001557|FG002|Participant Flow|Core Phase: Lemborexant 5 mg|Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297300|NCT03001557|FG003|Participant Flow|Core Phase: Lemborexant 10 mg|Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297301|NCT03001557|FG004|Participant Flow|Core Phase: Lemborexant 15 mg|Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297302|NCT03001557|FG005|Participant Flow|Extension Phase: Lemborexant 5 mg|Participants who completed the core study end of study (EOS) visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for Irregular Sleep-Wake Rhythm Disorder (ISWRD) is discontinued or up to 30 months.
11297303|NCT03001557|FG006|Participant Flow|Extension Phase: Lemborexant 10 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297304|NCT03001557|FG007|Participant Flow|Extension Phase: Lemborexant 15 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297305|NCT03001557|OG000|Outcome|Core Phase: Lemborexant-matched Placebo|Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297306|NCT03001557|OG001|Outcome|Core Phase: Lemborexant 2.5 mg|Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297307|NCT03001557|OG002|Outcome|Core Phase: Lemborexant 5 mg|Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297308|NCT03001557|OG003|Outcome|Core Phase: Lemborexant 10 mg|Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297309|NCT03001557|OG004|Outcome|Core Phase: Lemborexant 15 mg|Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297310|NCT03001557|OG002|Outcome|Core Phase: Lemborexant 5 mg|Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period
11297311|NCT03001557|OG005|Outcome|Extension Phase: Lemborexant 5 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297312|NCT03001557|OG006|Outcome|Extension Phase: Lemborexant 10 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297313|NCT03001557|OG007|Outcome|Extension Phase: Lemborexant 15 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297314|NCT03001557|OG000|Outcome|Extension Phase: Lemborexant 5 mg|Participants who completed the core study end of study (EOS) visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for Irregular Sleep-Wake Rhythm Disorder (ISWRD) is discontinued or up to 30 months.
11297315|NCT03001557|OG001|Outcome|Extension Phase: Lemborexant 10 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297316|NCT03001557|OG002|Outcome|Extension Phase: Lemborexant 15 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297317|NCT03001557|EG000|Reported Event|Core Phase: Lemborexant-matched Placebo|Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297318|NCT03001557|EG001|Reported Event|Core Phase: Lemborexant 2.5 mg|Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297319|NCT03001557|EG002|Reported Event|Core Phase: Lemborexant 5 mg|Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297320|NCT03001557|EG003|Reported Event|Core Phase: Lemborexant 10 mg|Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297321|NCT03001557|EG004|Reported Event|Core Phase: Lemborexant 15 mg|Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.
11297322|NCT03001557|EG005|Reported Event|Extension Phase: Lemborexant 5 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297323|NCT03001557|EG006|Reported Event|Extension Phase: Lemborexant 10 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297324|NCT03001557|EG007|Reported Event|Extension Phase: Lemborexant 15 mg|Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.
11297325|NCT03001674|BG000|Baseline|IABP Recipient|Conductance catheterization: CD Leycom Conductance Catheter
11297326|NCT03001674|BG001|Baseline|Control|Conductance catheterization: CD Leycom Conductance Catheter
11297327|NCT03001674|BG002|Baseline|Total|Total of all reporting groups
11297328|NCT03001674|FG000|Participant Flow|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
11297329|NCT03001674|FG001|Participant Flow|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
11297330|NCT03001674|OG000|Outcome|IABP Recipient|"Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.~Conductance catheterization: CD Leycom Conductance Catheter"
11297331|NCT03001674|OG001|Outcome|Control|"Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.~Conductance catheterization: CD Leycom Conductance Catheter"
11297332|NCT03001674|EG000|Reported Event|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
11297333|NCT03001674|EG001|Reported Event|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
11297334|NCT03001778|BG000|Baseline|Community Usability Testing|"Prototype testing~Usability Testing: Usability testing of ready made workouts in a group format."
11297335|NCT03001778|BG001|Baseline|ILF Usability Testing|"Prototype testing~Usability Testing: Usability testing of ready made workouts in as an individual."
11297336|NCT03001778|BG002|Baseline|Total|Total of all reporting groups
11297337|NCT03001778|FG000|Participant Flow|Community Residents|"Community prototype testing~Usability Testing: Usability testing of ready made workouts."
11297338|NCT03001778|FG001|Participant Flow|ILF Resident Usability Testing|"ILF Prototype testing~Usability Testing: Usability testing of ready made workouts."
11297339|NCT03001778|OG000|Outcome|Community Residents|"Community prototype testing~Usability Testing: Usability testing of ready made workouts."
11297340|NCT03001778|OG001|Outcome|ILF Resident Usability Testing|"ILF Prototype testing~Usability Testing: Usability testing of ready made workouts."
11297341|NCT03001778|EG000|Reported Event|Community Usability Testing|"Prototype testing~Usability Testing: Usability testing of ready-made workouts in a group format."
11297342|NCT03001778|EG001|Reported Event|ILF Usability Testing|"Prototype testing~Usability Testing: Usability testing of ready-made workouts in a group format."
11297343|NCT03001843|BG000|Baseline|Non-Ketamine|"This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.~Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297344|NCT03001843|BG001|Baseline|Ketamine|"This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.~Ketamine: Anesthesia of only Ketamine~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297345|NCT03001843|BG002|Baseline|Total|Total of all reporting groups
11297346|NCT03001843|FG000|Participant Flow|Non-Ketamine|"This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.~Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297347|NCT03001843|FG001|Participant Flow|Ketamine|"This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.~Ketamine: Anesthesia of only Ketamine~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
10848340|NCT00289718|EG000|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
11297348|NCT03001843|OG000|Outcome|Non-Ketamine|"This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.~Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297349|NCT03001843|OG001|Outcome|Ketamine|"This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.~Ketamine: Anesthesia of only Ketamine~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297350|NCT03001843|EG000|Reported Event|Non-Ketamine|"This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.~Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297351|NCT03001843|EG001|Reported Event|Ketamine|"This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.~Ketamine: Anesthesia of only Ketamine~pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain"
11297352|NCT03002012|BG000|Baseline|Sertraline|"Fluconazole Standard of Care + Sertraline~Sertraline: sertraline 400mg/day~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297353|NCT03002012|BG001|Baseline|Control|"Fluconazole Standard of Care + Placebo Oral Tablet~Placebo Oral Tablet: matched placebo tablet~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297354|NCT03002012|BG002|Baseline|Total|Total of all reporting groups
11297355|NCT03002012|FG000|Participant Flow|Sertraline|"Fluconazole Standard of Care + Sertraline~Sertraline: sertraline 400mg/day~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297356|NCT03002012|FG001|Participant Flow|Control|"Fluconazole Standard of Care + Placebo Oral Tablet~Placebo Oral Tablet: matched placebo tablet~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297357|NCT03002012|OG000|Outcome|Sertraline|"Fluconazole Standard of Care + Sertraline~Sertraline: sertraline 400mg/day~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297358|NCT03002012|OG001|Outcome|Control|"Fluconazole Standard of Care + Placebo Oral Tablet~Placebo Oral Tablet: matched placebo tablet~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297359|NCT03002012|EG000|Reported Event|Sertraline|"Fluconazole Standard of Care + Sertraline~Sertraline: sertraline 400mg/day~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297360|NCT03002012|EG001|Reported Event|Control|"Fluconazole Standard of Care + Placebo Oral Tablet~Placebo Oral Tablet: matched placebo tablet~Fluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months)."
11297361|NCT03002038|BG000|Baseline|Azathioprine|"Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.~Azathioprine: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose."
11297362|NCT03002038|BG001|Baseline|Rituximab|"Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.~Rituximab: Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months."
11297363|NCT03002038|BG002|Baseline|Total|Total of all reporting groups
11297364|NCT03002038|FG000|Participant Flow|Azathioprine|"Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.~Azathioprine: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose."
11297365|NCT03002038|FG001|Participant Flow|Rituximab|"Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.~Rituximab: Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months."
11297366|NCT03002038|OG000|Outcome|Azathioprine|"Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.~Azathioprine: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose."
11297367|NCT03002038|OG001|Outcome|Rituximab|"Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.~Rituximab: Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months."
11297368|NCT03002038|EG000|Reported Event|Azathioprine|"Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.~Azathioprine: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose."
11297369|NCT03002038|EG001|Reported Event|Rituximab|"Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.~Rituximab: Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months."
11297370|NCT03002077|BG000|Baseline|Rapastinel|Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
11297371|NCT03002077|FG000|Participant Flow|Rapastinel|Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
11297372|NCT03002077|OG000|Outcome|Rapastinel|Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
11297373|NCT03002077|EG000|Reported Event|Rapastinel|Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
11297374|NCT03002194|BG000|Baseline|Treatment Group|Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies.
11297375|NCT03002194|FG000|Participant Flow|RF and PEMF Therapy|"Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs.~Cutometer: Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.~Photographs: Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment."
11297376|NCT03002194|OG000|Outcome|RF and PEMF Therapy|"Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs.~Cutometer: Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.~Photographs: Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment."
11332738|NCT03500679|OG000|Outcome|ExPEC4V|Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
10848341|NCT00289731|BG000|Baseline|Twinrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
11217088|NCT02310763|OG000|Outcome|Sequence 1|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants continued to receive domagrozumab at the maximum tolerated dose (40 mg/kg) every 4 weeks for additional 48 weeks or until early termination of the study.
11217089|NCT02310763|OG001|Outcome|Sequence 2|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants received placebo for additional 48 weeks or until early termination of the study.
11217090|NCT02310763|OG002|Outcome|Sequence 3|Participants in this sequence received placebo for 48 weeks (Period 1). From Week 49 (Period 2), participants received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for additional 48 weeks or until early termination of the study. At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses).
11217091|NCT02310763|OG001|Outcome|Domagrozumab|Participants received domagrozumab in a dose escalating fashion (5, 20 and 40mg/kg) from Week 1 to Week 48. At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses).
10971361|NCT00915343|OG000|Outcome|Hydrocortisone MR Tablet OD - Part A|During the 4-week run-in period prior to the first intervention period during Part A, participants on a twice-a-day (BID) regimen were transferred to a thrice-a-day (TID) regimen while maintaining the same total daily hydrocortisone dose. In the first and second intervention periods during Part A, participants were randomised to novel once daily (OD) treatment with hydrocortisone modified release (MR) tablets 20 to 40 milligram (mg) orally and the treatment continued for 12 weeks and returned every 4 weeks for study drug dispensation.
11217092|NCT02310763|OG000|Outcome|Sequence 3|Participants in this sequence received placebo for 48 weeks (Period 1). From Week 49 (Period 2), participants received domagrozumab in a dose escalating fashion (5, 20 and 40 mg/kg) for additional 48 weeks or until early termination of the study. At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses).
11217093|NCT02310763|OG000|Outcome|Domagrozumab 5 mg/kg|Participants received domagrozumab at a dose of 5 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 1 to Week 16 (4 doses).
11217094|NCT02310763|OG001|Outcome|Domagrozumab 20 mg/kg|Participants received domagrozumab at a dose of 20 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 17 to Week 32 (4 doses).
11217095|NCT02310763|OG002|Outcome|Domagrozumab 40 mg/kg|Participants received domagrozumab at a dose of 40 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 33 to Week 48 (4 doses).
11217096|NCT02310763|OG000|Outcome|Domagrozumab 5 mg/kg|Participants received domagrozumab at a dose of 5 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 49 to Week 64 (4 doses).
11217097|NCT02310763|OG001|Outcome|Domagrozumab 20 mg/kg|Participants received domagrozumab at a dose of 20 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 65 to Week 80 (4 doses).
11217098|NCT02310763|OG002|Outcome|Domagrozumab 40 mg/kg|Participants received domagrozumab at a dose of 40 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 81 to Week 96 (4 doses).
11217099|NCT02310763|OG000|Outcome|Sequence 2|Participants in this sequence received domagrozumab in a dose escalating fashion (5, 20 and 40mg/kg) for 48 weeks (Period 1). At each dose level, dosing was administered over 2 hours by intravenous infusion every 4 weeks for a total of 16 weeks (4 doses). From Week 49 (Period 2), participants received placebo for additional 48 weeks or until early termination of the study.
11217100|NCT02310763|EG000|Reported Event|Domagrozumab 5 mg/kg, Period 1|Participants received domagrozumab at a dose of 5 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 1 to Week 16 (4 doses).
11217101|NCT02310763|EG001|Reported Event|Domagrozumab 20 mg/kg, Period 1|Participants received domagrozumab at a dose of 20 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 17 to Week 32 (4 doses).
11217102|NCT02310763|EG002|Reported Event|Domagrozumab 40 mg/kg, Period 1|Participants received domagrozumab at a dose of 40 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 33 to Week 48 (4 doses).
11217103|NCT02310763|EG003|Reported Event|Placebo, Period 1|Participants received placebo from Week 1 to Week 48.
11217104|NCT02310763|EG004|Reported Event|Domagrozumab 5 mg/kg, Period 2|Participants received domagrozumab at a dose of 5 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 49 to Week 64 (4 doses).
11217105|NCT02310763|EG005|Reported Event|Domagrozumab 20 mg/kg, Period 2|Participants received domagrozumab at a dose of 20 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 65 to Week 80 (4 doses).
11217106|NCT02310763|EG006|Reported Event|Domagrozumab 40 mg/kg, Period 2|Participants received domagrozumab at a dose of 40 mg/kg over 2 hours by intravenous infusion every 4 weeks from Week 81 to Week 96 (4 doses).
11217107|NCT02310763|EG007|Reported Event|Placebo, Period 2|Participants received placebo from Week 49 to Week 96.
11217108|NCT02310776|BG000|Baseline|Automated & Handheld Beast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11217109|NCT02310776|FG000|Participant Flow|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11332739|NCT03500679|OG001|Outcome|Placebo|Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
11332740|NCT03500679|EG000|Reported Event|ExPEC4V|Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
11297377|NCT03002194|EG000|Reported Event|RF and PEMF Therapy|"Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs.~Cutometer: Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.~Photographs: Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment."
11297378|NCT03002311|BG000|Baseline|Control|Receiving current standard of care as designated by emergency department (ED) standard operating practice.
11297379|NCT03002311|BG001|Baseline|Epharmix/CareSignal eHealth Intervention|Epharmix/CareSignal eHealth: The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm attendance.
11297380|NCT03002311|BG002|Baseline|Total|Total of all reporting groups
11297381|NCT03002311|FG000|Participant Flow|Control|Receiving current standard of care as designated by emergency department (ED) standard operating practice.
11297382|NCT03002311|FG001|Participant Flow|Epharmix/CareSignal eHealth Intervention|Epharmix/CareSignal eHealth: The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm attendance.
11297383|NCT03002311|OG000|Outcome|Control|Receiving current standard of care as designated by emergency department (ED) standard operating practice.
11297384|NCT03002311|OG001|Outcome|Epharmix/CareSignal eHealth Intervention|Epharmix/CareSignal eHealth: The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm attendance.
11297385|NCT03002311|EG000|Reported Event|Control|Receiving current standard of care as designated by emergency department (ED) standard operating practice.
11297386|NCT03002311|EG001|Reported Event|Epharmix/CareSignal eHealth Intervention|Epharmix/CareSignal eHealth: The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm attendance.
11297387|NCT03002454|BG000|Baseline|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
11297388|NCT03002454|FG000|Participant Flow|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. All 4 participants initially had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~3-28 days later all participants had a second bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
11297389|NCT03002454|OG000|Outcome|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
10971362|NCT00915343|OG000|Outcome|Hydrocortisone OD Versus TID|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study. Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
10971363|NCT00915343|EG000|Reported Event|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone modified release (MR) tablets 20 to 40 mg orally, once daily (OD) during the 12-week period of Part A.
11297390|NCT03002454|EG000|Reported Event|99mTc MDP Injection:Fission|"Oncologic indication for which a bone scan would normally be indicated.~99mTc MDP Injection:fission: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo."
11297391|NCT03002454|EG001|Reported Event|99mTc MDP Injection:Neutron-bombardment|"Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.~99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo."
11297392|NCT03002506|BG000|Baseline|Ceftolozane/Tazobactam|"One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.~Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes."
11297393|NCT03002506|FG000|Participant Flow|Ceftolozane/Tazobactam|"One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.~Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes."
11297394|NCT03002506|OG000|Outcome|Ceftolozane/Tazobactam|"One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.~Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes."
11297395|NCT03002506|EG000|Reported Event|Ceftolozane/Tazobactam|"One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.~Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes."
11297396|NCT03002610|BG000|Baseline|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11297397|NCT03002610|BG001|Baseline|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11297398|NCT03002610|BG002|Baseline|Scientific Abstract|"Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.~Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic."
11297399|NCT03002610|BG003|Baseline|Total|Total of all reporting groups
11297400|NCT03002610|FG000|Participant Flow|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11297401|NCT03002610|FG001|Participant Flow|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11297402|NCT03002610|FG002|Participant Flow|Scientific Abstract|"Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.~Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic."
11297403|NCT03002610|OG000|Outcome|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11297404|NCT03002610|OG001|Outcome|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11297405|NCT03002610|OG002|Outcome|Scientific Abstract|"Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.~Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic."
11297406|NCT03002610|EG000|Reported Event|Plain Language Summary|"The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.~Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience."
11297407|NCT03002610|EG001|Reported Event|Infographics|"Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.~Infographics: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS."
11297408|NCT03002610|EG002|Reported Event|Scientific Abstract|"Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group.~Scientific abstract: Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic."
11332741|NCT03500679|EG001|Reported Event|Placebo|Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
11332742|NCT03501043|BG000|Baseline|Dysport|All Participants
11332743|NCT03501043|FG000|Participant Flow|Dysport|All Participants
11332744|NCT03501043|OG000|Outcome|Barefoot SSV|SSV reported in participants walking barefoot.
11332745|NCT03501043|OG001|Outcome|Shoes SSV|SSV reported in participants walking in shoes.
11332746|NCT03501043|OG000|Outcome|Barefoot MV|MV reported in participants walking barefoot.
11217110|NCT02310776|OG000|Outcome|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11217111|NCT02310776|EG000|Reported Event|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11217112|NCT02310789|BG000|Baseline|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
11217113|NCT02310789|FG000|Participant Flow|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
11217114|NCT02310789|OG000|Outcome|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
11217115|NCT02310789|EG000|Reported Event|Ivacaftor|Participants received ivacaftor orally for 3 days, followed by 35 days off drug. Participants repeated this cycle then received ivacaftor for 3 additional days. For sweat testing, participants received β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant also received pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing was done on- and off-ivacaftor.
11217116|NCT02310906|BG000|Baseline|Part 1: Placebo|Participants received placebo-matched to golodirsen intravenous (IV) infusions, once weekly up to 12 weeks in Part 1.
11217117|NCT02310906|BG001|Baseline|Part 1: Golodirsen|Participants received golodirsen IV infusions, at four dose levels of 4 milligrams per kilograms (mg/kg) once weekly for 2 weeks, followed by 10 mg/kg once weekly for the next 2 weeks (i.e., up to Week 4), followed by 20 mg/kg once weekly for the next 2 weeks (i.e., up to Week 6), followed by 30 mg/kg once weekly from Week 7 to Week 12 in Part 1.
11217118|NCT02310906|BG002|Baseline|Part 2a: Total Golodirsen Group|All participants from Part 1 (who previously received placebo or golodirsen) and including additional new participants received golodirsen 30 milligram (mg)/kilogram (kg) once weekly, for up to 168 weeks. Dosing was interrupted or halted when any specific predefined stopping criteria was met or if warranted at the discretion of the Sponsor or Investigator.
11217119|NCT02310906|BG003|Baseline|Part 2b: Untreated Group (Natural History of Non-exon 53)|Untreated participants intended to evaluate the natural history of the disease with DMD and various genetic mutations (not amenable to exon 53 skipping) were included in this group and did not received any treatment. Participants underwent the same study assessments as treated participants in other reporting groups (except for PK sampling and muscle biopsies), but at a reduced schedule through Week 144. Thus, the untreated participants were not considered as control group.
11217120|NCT02310906|BG004|Baseline|Total|Total of all reporting groups
11217121|NCT02310906|FG000|Participant Flow|Part 1: Placebo|Participants received placebo-matched to golodirsen intravenous (IV) infusions, once weekly up to 12 weeks in Part 1.
11217122|NCT02310906|FG001|Participant Flow|Part 1: Golodirsen|Participants received golodirsen IV infusions, at four dose levels of 4 milligrams per kilograms (mg/kg) once weekly for 2 weeks, followed by 10 mg/kg once weekly for the next 2 weeks (i.e., up to Week 4), followed by 20 mg/kg once weekly for the next 2 weeks (i.e., up to Week 6), followed by 30 mg/kg once weekly from Week 7 to Week 12 in Part 1.
11217123|NCT02310906|FG002|Participant Flow|Part 2a: Total Golodirsen Group|All participants from Part 1 (who previously received placebo or golodirsen) and including additional new participants received golodirsen 30 milligram (mg)/kilogram (kg) once weekly, for up to 168 weeks. Dosing was interrupted or halted when any specific predefined stopping criteria was met or if warranted at the discretion of the Sponsor or Investigator.
11217124|NCT02310906|FG003|Participant Flow|Part 2b: Untreated Group (Natural History of Non-exon 53)|Untreated participants intended to evaluate the natural history of the disease with DMD and various genetic mutations (not amenable to exon 53 skipping) were included in this group and did not received any treatment. Participants underwent the same study assessments as treated participants in other reporting groups (except for pharmacokinetic [PK] sampling and muscle biopsies), but at a reduced schedule through Week 144. Thus, the untreated participants were not considered as control group.
11217125|NCT02310906|OG000|Outcome|Part 1: Placebo|Participants received placebo-matched to golodirsen IV infusions, once weekly for up to 12 weeks in Part 1.
11217126|NCT02310906|OG001|Outcome|Part 1: Golodirsen (4 mg/kg)|Participants received golodirsen IV infusions, at dose levels of 4 mg/kg, once weekly for 2 weeks in Part 1.
11217127|NCT02310906|OG002|Outcome|Part 1: Golodirsen (10 mg/kg)|Participants received golodirsen IV infusions, at a dose levels of 10 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 4) in Part 1.
11332747|NCT03501043|OG001|Outcome|Shoes MV|MV reported in participants walking in shoes.
11332748|NCT03501043|OG000|Outcome|Barefoot Step-Length|Step-length reported in participants walking barefoot.
11332749|NCT03501043|OG001|Outcome|Shoes Step-Length|Step-length reported in participants walking in shoes.
11332750|NCT03501043|OG000|Outcome|MAS Ankle Knee Flexed|Change in ankle knee flexion MAS score
11297409|NCT03002623|BG000|Baseline|Anaplastic Thyroid Cancer|CUDC-907 for anaplastic thyroid cancer CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off.
11297410|NCT03002623|BG001|Baseline|Poorly Differentiated/Variants of Thyroid Cancer|"CUDC-907 for Poorly differentiated and aggressive variants of differentiated thyroid cancer.~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297411|NCT03002623|BG002|Baseline|Total|Total of all reporting groups
11297412|NCT03002623|FG000|Participant Flow|Anaplastic Thyroid Cancer|"CUDC-907 for anaplastic thyroid cancer~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297413|NCT03002623|FG001|Participant Flow|Poorly Differentiated/Variants of Thyroid Cancer|"CUDC-907 for Poorly differentiated and aggressive variants of differentiated thyroid cancer.~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297414|NCT03002623|OG000|Outcome|Anaplastic Thyroid Cancer|CUDC-907 for anaplastic thyroid cancer CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off.
11297415|NCT03002623|OG001|Outcome|Poorly Differentiated/Variants of Thyroid Cancer|"CUDC-907 for Poorly differentiated and aggressive variants of differentiated thyroid cancer.~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297416|NCT03002623|OG000|Outcome|All Participants|"CUDC-907 for anaplastic thyroid cancer CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off.~CUDC-907 for Poorly differentiated and aggressive variants of differentiated thyroid cancer.~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297417|NCT03002623|OG000|Outcome|Anaplastic Cancer|CUDC-907 for anaplastic thyroid cancer CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off.
10971364|NCT00915343|EG001|Reported Event|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally, thrice daily (TID) during the 12-week period of Part A.
11297418|NCT03002623|EG000|Reported Event|Anaplastic Thyroid Cancer|CUDC-907 for anaplastic thyroid cancer CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off.
11297419|NCT03002623|EG001|Reported Event|Poorly Differentiated/Variants of Thyroid Cancer|"CUDC-907 for Poorly differentiated and aggressive variants of differentiated thyroid cancer.~CUDC-907: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day, 5 days on and 2 days off."
11297420|NCT03002753|BG000|Baseline|Detached Mindfulness|Group of patients receiving detached mindfulness (for details, see detailed description of the study)
11297421|NCT03002753|BG001|Baseline|Cognitive Restructuring|Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
11297422|NCT03002753|BG002|Baseline|Total|Total of all reporting groups
11297423|NCT03002753|FG000|Participant Flow|Detached Mindfulness|Group of patients receiving detached mindfulness (for details, see detailed description of the study)
11297424|NCT03002753|FG001|Participant Flow|Cognitive Restructuring|Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
11297425|NCT03002753|FG002|Participant Flow|Waitlist|Group of patients who are re-randomized to either Detached Mindfulness or Cognitive Restructuring after a delay of 2 weeks.
11297426|NCT03002753|OG000|Outcome|Detached Mindfulness|Group of patients receiving detached mindfulness (for details, see detailed description of the study)
11297427|NCT03002753|OG001|Outcome|Cognitive Restructuring|Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
11297428|NCT03002753|OG002|Outcome|Waitlist|Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
11297429|NCT03002753|EG000|Reported Event|Detached Mindfulness (DM)|Group of patients receiving detached mindfulness (for details, see detailed description of the study)
11297430|NCT03002753|EG001|Reported Event|Cognitive Restructuring (CR)|Group of patients receiving cognitive restructuring (for details, see detailed description of the study)
11297431|NCT03002753|EG002|Reported Event|Waitlist (WL)|Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
11297432|NCT03002818|BG000|Baseline|HCV Genotype 1 Participants|Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
11297433|NCT03002818|FG000|Participant Flow|Hepatitis C Virus (HCV) Genotype 1 Participants|Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
11297434|NCT03002818|OG000|Outcome|HCV Genotype 1 Participants|Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
11297435|NCT03002818|EG000|Reported Event|HCV Genotype 1 Participants|Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
11297436|NCT03002974|BG000|Baseline|Triamcinolone 40 mg|"2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg~Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe"
11297437|NCT03002974|BG001|Baseline|Anakinra 100 mg|"1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11332751|NCT03501043|OG001|Outcome|MAS Ankle Knee Extended|Change in ankle knee extension MAS score
11332752|NCT03501043|OG000|Outcome|TS Ankle Knee Flexed Spasticity Grade|Participants were measured by the muscles' responses to stretch at given velocities.
11332753|NCT03501043|OG001|Outcome|TS Ankle Knee Extended Spasticity Grade|Participants were measured by the muscles' responses to stretch at given velocities.
11332754|NCT03501043|OG000|Outcome|PROM Ankle Knee Flexed|PROM measured at ankle knee flexed.
11297438|NCT03002974|BG002|Baseline|Anakinra 200 mg|"2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297439|NCT03002974|BG003|Baseline|Total|Total of all reporting groups
11297440|NCT03002974|FG000|Participant Flow|Triamcinolone 40 mg|"2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg~Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe"
11297441|NCT03002974|FG001|Participant Flow|Anakinra 100 mg|"1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297442|NCT03002974|FG002|Participant Flow|Anakinra 200 mg|"2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297443|NCT03002974|OG000|Outcome|Triamcinolone 40 mg|"2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg~Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe"
11297444|NCT03002974|OG001|Outcome|Anakinra 100 mg|"1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297445|NCT03002974|OG002|Outcome|Anakinra 200 mg|"2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297446|NCT03002974|EG000|Reported Event|Triamcinolone 40 mg|"2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg~Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe"
11297447|NCT03002974|EG001|Reported Event|Anakinra 100 mg|"1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297448|NCT03002974|EG002|Reported Event|Anakinra 200 mg|"2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg~Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection~Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension"
11297449|NCT03003000|BG000|Baseline|Placebo|Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297450|NCT03003000|BG001|Baseline|Ibuprofen|Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297451|NCT03003000|BG002|Baseline|Ibuprofen and Caffeine|Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297452|NCT03003000|BG003|Baseline|Total|Total of all reporting groups
11297453|NCT03003000|FG000|Participant Flow|Placebo|Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297454|NCT03003000|FG001|Participant Flow|Ibuprofen|Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297455|NCT03003000|FG002|Participant Flow|Ibuprofen and Caffeine|Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297456|NCT03003000|OG000|Outcome|Placebo|Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297457|NCT03003000|OG001|Outcome|Ibuprofen|Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297458|NCT03003000|OG002|Outcome|Ibuprofen and Caffeine|Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297459|NCT03003000|EG000|Reported Event|Placebo|Patients were administered placebo matching ibuprofen and ibuprofen/caffeine film-coated tablets orally 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297460|NCT03003000|EG001|Reported Event|Ibuprofen|Patients were administered film-coated tablets orally containing 400 mg ibuprofen 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297461|NCT03003000|EG002|Reported Event|Ibuprofen and Caffeine|Patients were administered film-coated tablets orally containing 400 mg ibuprofen and 100 mg caffeine 3 times daily with intervals of 6 to 8 hours (while awake) on Day 1 until the morning of Day 6.
11297462|NCT03003130|BG000|Baseline|Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF|Restylane Defyne treated in the right NLF followed by Restylane in the left NLF
11297463|NCT03003130|BG001|Baseline|Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF|Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
11297464|NCT03003130|BG002|Baseline|Total|Total of all reporting groups
11297465|NCT03003130|FG000|Participant Flow|Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF|Restylane Defyne treated in the right NLF followed by Restylane in the left NLF
11297466|NCT03003130|FG001|Participant Flow|Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF|Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
11297467|NCT03003130|OG000|Outcome|Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF|Restylane Defyne treated in the right NLF followed by Restylane in the left NLF
11297468|NCT03003130|OG001|Outcome|Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF|Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
11297469|NCT03003130|EG000|Reported Event|Restylane Defyne|Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.
11297470|NCT03003130|EG001|Reported Event|Restylane|Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.
11297471|NCT03003390|BG000|Baseline|Prophylaxis With Enoxaparin|"A clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter.~Enoxaparin: The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL."
11297472|NCT03003390|BG001|Baseline|Control Arm|Participants randomized to the control arm will receive no 'placebo' intervention.
10971365|NCT00915343|EG002|Reported Event|Hydrocortisone MR Tablet OD - Part B (First 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the first 3 months of Part B (6 months).
10971366|NCT00915343|EG003|Reported Event|Hydrocortisone MR Tablet OD - Part B (Second 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the second 3 months of Part B (6 months).
11297473|NCT03003390|BG002|Baseline|Total|Total of all reporting groups
11297474|NCT03003390|FG000|Participant Flow|Prophylaxis With Enoxaparin|"A clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter.~Enoxaparin: The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL."
11297475|NCT03003390|FG001|Participant Flow|Control Arm|Participants randomized to the control arm will receive no 'placebo' intervention.
11297476|NCT03003390|OG000|Outcome|Prophylaxis With Enoxaparin|"A clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter.~Enoxaparin: The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL."
11297477|NCT03003390|OG001|Outcome|Control Arm|Participants randomized to the control arm will receive no 'placebo' intervention.
11297478|NCT03003390|OG000|Outcome|Eligible Children|Children eligible to participate in this study.
11297479|NCT03003390|OG000|Outcome|Prophylaxis With Enoxaparin|Participants in the treatment arm received enoxaparin.
11297480|NCT03003390|OG000|Outcome|Prophylaxis With Enoxaparin|Children were treated with enoxaparin
11297481|NCT03003390|OG000|Outcome|Prophylaxis With Enoxaparin|children were treated with enoxaparin
11297482|NCT03003390|OG000|Outcome|All Enrolled Children|All children who participated in the study
11297483|NCT03003390|EG000|Reported Event|Prophylaxis With Enoxaparin|"A clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter.~Enoxaparin: The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL."
11297484|NCT03003390|EG001|Reported Event|Control Arm|Participants randomized to the control arm will receive no 'placebo' intervention.
11297485|NCT03003494|BG000|Baseline|Spiolto Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11297486|NCT03003494|FG000|Participant Flow|Spiolto Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11297487|NCT03003494|OG000|Outcome|Spiolto Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11297488|NCT03003494|EG000|Reported Event|Spiolto Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
11297489|NCT03003676|BG000|Baseline|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1|"Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297490|NCT03003676|BG001|Baseline|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2|"Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297491|NCT03003676|BG002|Baseline|Total|Total of all reporting groups
11297492|NCT03003676|FG000|Participant Flow|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 1|"Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will receive pembrolizumab i.v., 2mg/kg or 200 mg flat dose on day 22 (Week 3) and every three weeks thereafter until Day 169/Week 24.~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297493|NCT03003676|FG001|Participant Flow|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 2|"Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade"
11297494|NCT03003676|OG000|Outcome|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1|"Part I1 Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297495|NCT03003676|OG001|Outcome|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2|"Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11332755|NCT03501043|OG001|Outcome|PROM Ankle Knee Extended|PROM measured at ankle knee extended.
10971367|NCT00915343|EG004|Reported Event|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the entire 6-month period of Part B.
10971368|NCT00915356|BG000|Baseline|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
11332756|NCT03501043|EG000|Reported Event|Dysport|Participants that received Dysport.
11332757|NCT03501069|BG000|Baseline|Non-Japanese Cohort 1: TAK-418 120 mg + Placebo|TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.
11332758|NCT03501069|BG001|Baseline|Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg|TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
10971369|NCT00915356|BG001|Baseline|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
11297496|NCT03003676|OG000|Outcome|Part 1|"Part 1: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297497|NCT03003676|OG001|Outcome|Part 2|"Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297498|NCT03003676|EG000|Reported Event|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1|"Part 1: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297499|NCT03003676|EG001|Reported Event|Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2|"Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).~ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)~Cyclophosphamide: Pre-treatment~Pembrolizumab: PD1 blockade"
11297500|NCT03003793|BG000|Baseline|Control Group|Healthy control subjects Hyperinsulinemic euglycemic clamp
11297501|NCT03003793|BG001|Baseline|Atopic Dermatitis/Eczema Group|Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
11297502|NCT03003793|BG002|Baseline|Total|Total of all reporting groups
11297503|NCT03003793|FG000|Participant Flow|Control Group|Healthy control subjects Hyperinsulinemic euglycemic clamp
11297504|NCT03003793|FG001|Participant Flow|Atopic Dermatitis/Eczema Group|Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
11297505|NCT03003793|OG000|Outcome|Control Group|Healthy control subjects Hyperinsulinemic euglycemic clamp
11297506|NCT03003793|OG001|Outcome|Atopic Dermatitis/Eczema Group|Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
11297507|NCT03003793|EG000|Reported Event|Control Group|Healthy control subjects Hyperinsulinemic euglycemic clamp
11297508|NCT03003793|EG001|Reported Event|Atopic Dermatitis/Eczema Group|Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
11297509|NCT03003949|BG000|Baseline|Placebo Patch and Placebo Capsule|"Placebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days.~Placebo Patch: Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).~Placebo Oral Capsule: Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week."
11297510|NCT03003949|BG001|Baseline|Estradiol Patch and Progesterone Capsule|"Estradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days.~Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).~Progesterone Capsule: Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week"
11297511|NCT03003949|BG002|Baseline|Total|Total of all reporting groups
11297512|NCT03003949|FG000|Participant Flow|Placebo Patch and Placebo Capsule|"Placebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days.~Placebo Patch: Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).~Placebo Oral Capsule: Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week."
11297513|NCT03003949|FG001|Participant Flow|Estradiol Patch and Progesterone Capsule|"Estradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days.~Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).~Progesterone Capsule: Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week"
11297514|NCT03003949|OG000|Outcome|Placebo Patch and Placebo Capsule|"Placebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days.~Placebo Patch: Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).~Placebo Oral Capsule: Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week."
11332759|NCT03501069|BG002|Baseline|Non-Japanese Cohort 1: Placebo + TAK-418 160 mg|TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
11332760|NCT03501069|BG003|Baseline|Non-Japanese Cohorts 2 to 4: Pooled Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11217128|NCT02310906|OG003|Outcome|Part 1: Golodirsen (20 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 20 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 6) in Part 1.
11217129|NCT02310906|OG004|Outcome|Part 1: Golodirsen (30 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 30 mg/kg, once weekly from Week 7 to Week 12 in Part 1.
11217130|NCT02310906|OG000|Outcome|Part 2a: Total Golodirsen Group|All participants from Part 1 (who previously received placebo or golodirsen) and including additional new participants received golodirsen 30 mg/kg once weekly, for up to 168 weeks in Part 2. Dosing was interrupted or halted when any specific predefined stopping criteria was met or if warranted at the discretion of the Sponsor or Investigator.
11217131|NCT02310906|OG000|Outcome|Part 2b: Untreated Group (Natural History of Non-exon 53)|Untreated participants intended to evaluate the natural history of the disease with DMD and various genetic mutations (not amenable to exon 53 skipping) were included in this group and did not received any treatment. Participants underwent the same study assessments as treated participants in other reporting groups (except for PK sampling and muscle biopsies), but at a reduced schedule through Week 144. Thus, the untreated participants were not considered as control group.
11217132|NCT02310906|OG000|Outcome|Part 1: Golodirsen (4 mg/kg)|Participants received golodirsen IV infusions, at dose levels of 4 mg/kg, once weekly for 2 weeks in Part 1.
11217133|NCT02310906|OG001|Outcome|Part 1: Golodirsen (10 mg/kg)|Participants received golodirsen IV infusions, at a dose levels of 10 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 4) in Part 1.
11217134|NCT02310906|OG002|Outcome|Part 1: Golodirsen (20 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 20 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 6) in Part 1.
11217135|NCT02310906|OG003|Outcome|Part 1: Golodirsen (30 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 30 mg/kg, once weekly from Week 7 to Week 12 in Part 1.
11217136|NCT02310906|OG000|Outcome|Part 2b: Untreated Group (Natural History of Non-exon 53)|Untreated participants intended to evaluate the natural history of the disease with DMD and various genetic mutations (not amenable to exon 53 skipping) were included in this group and did not received any treatment. Participants underwent the same study assessments as treated participants in other reporting groups (except for PK sampling and muscle biopsies), but at a reduced schedule through Week 144.Thus, the untreated participants were not considered as control group.
11217137|NCT02310906|EG000|Reported Event|Part 1: Placebo|Participants received placebo-matched to golodirsen IV infusions, once weekly for up to 12 weeks in Part 1.
11217138|NCT02310906|EG001|Reported Event|Part 1: Golodirsen (4 mg/kg)|Participants received golodirsen IV infusions, at dose levels of 4 mg/kg, once weekly for 2 weeks in Part 1.
11217139|NCT02310906|EG002|Reported Event|Part 1: Golodirsen (10 mg/kg)|Participants received golodirsen IV infusions, at a dose levels of 10 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 4) in Part 1.
11217140|NCT02310906|EG003|Reported Event|Part 1: Golodirsen (20 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 20 mg/kg, once weekly for the next 2 weeks (i.e., up to Week 6) in Part 1.
11217141|NCT02310906|EG004|Reported Event|Part 1: Golodirsen (30 mg/kg)|Participants received golodirsen IV infusions, at a dose level of 30 mg/kg, once weekly from Week 7 to Week 12 in Part 1.
11217142|NCT02310906|EG005|Reported Event|Part 2a: Total Golodirsen Group|All participants from Part 1 (who previously received placebo or golodirsen) and including additional new participants received golodirsen 30 mg/kg once weekly, for up to 168 weeks in Part 2. Dosing was interrupted or halted when any specific predefined stopping criteria was met or if warranted at the discretion of the Sponsor or Investigator.
11217143|NCT02310906|EG006|Reported Event|Part 2b: Untreated Group (Natural History of Non-exon 53)|Untreated participants intended to evaluate the natural history of the disease with DMD and various genetic mutations (not amenable to exon 53 skipping) were included in this group and did not received any treatment. Participants underwent the same study assessments as treated participants in other reporting groups (except for PK sampling and muscle biopsies), but at a reduced schedule through Week 144. Thus, the untreated participants were not considered as control group.
11217144|NCT02311153|BG000|Baseline|Endotracheal Intubation|"Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure~Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT."
11217145|NCT02311153|BG001|Baseline|Laryngeal Mask Airway|"Laryngeal mask for airway management and ventilation during sinonasal surgical procedure~Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation."
11217146|NCT02311153|BG002|Baseline|Total|Total of all reporting groups
11217147|NCT02311153|FG000|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure~Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT."
11217148|NCT02311153|FG001|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask for airway management and ventilation during sinonasal surgical procedure~Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation."
10971370|NCT00915356|BG002|Baseline|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
11217149|NCT02311153|OG000|Outcome|Endotracheal Intubation|"Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure~Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT."
11217150|NCT02311153|OG001|Outcome|Laryngeal Mask Airway|"Laryngeal mask for airway management and ventilation during sinonasal surgical procedure~Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation."
11217151|NCT02311153|EG000|Reported Event|Endotracheal Intubation|"Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure~Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT."
11217152|NCT02311153|EG001|Reported Event|Laryngeal Mask Airway|"Laryngeal mask for airway management and ventilation during sinonasal surgical procedure~Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation."
11297515|NCT03003949|OG001|Outcome|Estradiol Patch and Progesterone Capsule|"Estradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days.~Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).~Progesterone Capsule: Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week"
11297516|NCT03003949|EG000|Reported Event|Placebo Patch and Placebo Capsule|"Placebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days.~Placebo Patch: Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).~Placebo Oral Capsule: Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week."
11297517|NCT03003949|EG001|Reported Event|Estradiol Patch and Progesterone Capsule|"Estradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days.~Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).~Progesterone Capsule: Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week"
11297518|NCT03004469|BG000|Baseline|P-3074 + Finasteride Placebo|Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks
11297519|NCT03004469|BG001|Baseline|P-3074 Vehicle + Finasteride Placebo|Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
11297520|NCT03004469|BG002|Baseline|Oral Finasteride + P-3074 Vehicle|Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
11297521|NCT03004469|BG003|Baseline|Total|Total of all reporting groups
11297522|NCT03004469|FG000|Participant Flow|P-3074 + Finasteride Placebo|Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks.
11297523|NCT03004469|FG001|Participant Flow|P-3074 Vehicle + Finasteride Placebo|Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
11297524|NCT03004469|FG002|Participant Flow|Oral Finasteride + P-3074 Vehicle|Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.
10971371|NCT00915356|BG003|Baseline|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
11297525|NCT03004469|OG000|Outcome|P-3074 + Finasteride Placebo|Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
11297526|NCT03004469|OG001|Outcome|P-3074 Vehicle + Finasteride Placebo|Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
11297527|NCT03004469|OG002|Outcome|Oral Finasteride + P-3074 Vehicle|Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
11297528|NCT03004469|OG000|Outcome|P-3074 + Finasteride Placebo|Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
11297529|NCT03004469|EG000|Reported Event|P-3074 + Finasteride Placebo|Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
11297530|NCT03004469|EG001|Reported Event|P-3074 Vehicle + Finasteride Placebo|Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
11297531|NCT03004469|EG002|Reported Event|Oral Finasteride + P-3074 Vehicle|Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
11297532|NCT03004534|BG000|Baseline|Presurgical Molecular Assessment|"Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.~darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg."
11297533|NCT03004534|FG000|Participant Flow|Presurgical Molecular Assessment|"Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.~darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg."
11297534|NCT03004534|OG000|Outcome|Presurgical Molecular Assessment|"Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.~darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg."
11297535|NCT03004534|EG000|Reported Event|Presurgical Molecular Assessment|"Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.~darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg."
11297536|NCT03004638|BG000|Baseline|Placebo|Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
11297537|NCT03004638|BG001|Baseline|Cohort 1: MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
11297538|NCT03004638|BG002|Baseline|Cohort 2: MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
11297539|NCT03004638|BG003|Baseline|Cohort 3: MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
11297540|NCT03004638|BG004|Baseline|Placebo IV Push|Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
11297541|NCT03004638|BG005|Baseline|Cohort 4: MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
11297542|NCT03004638|BG006|Baseline|Total|Total of all reporting groups
10971372|NCT00915356|BG004|Baseline|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
11297543|NCT03004638|FG000|Participant Flow|Placebo|Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
11297544|NCT03004638|FG001|Participant Flow|MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
11297545|NCT03004638|FG002|Participant Flow|MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
11297546|NCT03004638|FG003|Participant Flow|MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
11297547|NCT03004638|FG004|Participant Flow|Placebo IV Push|Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
11297548|NCT03004638|FG005|Participant Flow|MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
11297549|NCT03004638|OG000|Outcome|Placebo|Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
11297550|NCT03004638|OG001|Outcome|Cohort 1: MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
11297551|NCT03004638|OG002|Outcome|Cohort 2: MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
11297552|NCT03004638|OG003|Outcome|Cohort 3: MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
11297553|NCT03004638|OG004|Outcome|Placebo IV Push|Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
11297554|NCT03004638|OG005|Outcome|Cohort 4: MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
11297555|NCT03004638|OG000|Outcome|Cohort 1: MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
11297556|NCT03004638|OG001|Outcome|Cohort 2: MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
11297557|NCT03004638|OG002|Outcome|Cohort 3: MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
11297558|NCT03004638|OG003|Outcome|Cohort 4: MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
11297559|NCT03004638|EG000|Reported Event|Placebo|Description (Arm-group)
11297560|NCT03004638|EG001|Reported Event|MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
11297561|NCT03004638|EG002|Reported Event|MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
11297562|NCT03004638|EG003|Reported Event|MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
11297563|NCT03004638|EG004|Reported Event|Placebo IV Push|Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
11297564|NCT03004638|EG005|Reported Event|MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
11297565|NCT03004846|BG000|Baseline|GSK2981278 4%: Part A|Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
11297566|NCT03004846|BG001|Baseline|GSK2981278 4%: Part B|Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
11297567|NCT03004846|BG002|Baseline|Vehicle Ointment: Part B|Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
11297568|NCT03004846|BG003|Baseline|Total|Total of all reporting groups
11297569|NCT03004846|FG000|Participant Flow|GSK2981278 4%: Part A|Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
11297570|NCT03004846|FG001|Participant Flow|GSK2981278 4%: Part B|Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
11297571|NCT03004846|FG002|Participant Flow|Vehicle Ointment: Part B|Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
11297572|NCT03004846|OG000|Outcome|GSK2981278 4%: Part A|Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
11297573|NCT03004846|OG000|Outcome|GSK2981278 4%:Part A|Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
11297574|NCT03004846|OG000|Outcome|GSK2981278 4%: Part B|Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
11297575|NCT03004846|OG001|Outcome|Vehicle Ointment: Part B|Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
11297576|NCT03004846|EG000|Reported Event|GSK2981278 4%: Part A|Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
11297577|NCT03004846|EG001|Reported Event|GSK2981278 4%: Part B|Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
11297578|NCT03004846|EG002|Reported Event|Vehicle Ointment: Part B|Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
11297579|NCT03004911|BG000|Baseline|Mobile Application|The use of ProFibro app for 6 weeks
11297580|NCT03004911|BG001|Baseline|Paper Booklet|The use of the booklet for 6 weeks
11297581|NCT03004911|BG002|Baseline|Total|Total of all reporting groups
11297582|NCT03004911|FG000|Participant Flow|Mobile Application|The use of ProFibro mobile application for six weeks
11297583|NCT03004911|FG001|Participant Flow|Paper Booklet|The use of a 64-page booklet (with content similar to the mobile application) for six weeks
11297584|NCT03004911|OG000|Outcome|Mobile Application|The use of ProFibro app for 6 weeks
11297585|NCT03004911|OG001|Outcome|Paper Booklet|The use of the booklet for 6 weeks
11297586|NCT03004911|EG000|Reported Event|Mobile Application|The use of ProFibro app for 6 weeks
11297587|NCT03004911|EG001|Reported Event|Paper Booklet|The use of the booklet for 6 weeks
11297588|NCT03004924|BG000|Baseline|SHP640|Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
11297589|NCT03004924|BG001|Baseline|PVP-I 0.6%|Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
11297590|NCT03004924|BG002|Baseline|Placebo|Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
10971373|NCT00915356|BG005|Baseline|Total|Total of all reporting groups
11297591|NCT03004924|BG003|Baseline|Total|Total of all reporting groups
11297592|NCT03004924|FG000|Participant Flow|SHP640|Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.
11297593|NCT03004924|FG001|Participant Flow|PVP-I 0.6%|Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
11297594|NCT03004924|FG002|Participant Flow|Placebo|Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
11297595|NCT03004924|OG000|Outcome|SHP640|Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.
11297596|NCT03004924|OG001|Outcome|PVP-I 0.6%|Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
11297597|NCT03004924|OG002|Outcome|Placebo|Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
11297598|NCT03004924|OG000|Outcome|SHP640|Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
11297599|NCT03004924|EG000|Reported Event|SHP640|Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.
11297600|NCT03004924|EG001|Reported Event|PVP-I 0.6%|Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
11297601|NCT03004924|EG002|Reported Event|Placebo|Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
11297602|NCT03005041|BG000|Baseline|Overall Study Participants|All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment.
11297603|NCT03005041|FG000|Participant Flow|Experimental Oral Rinse/Mineral Water|Participants were supervised to rinse their mouth with 15 milliliter (mL) of the experimental oral rinse/mouth wash swishing followed by with 15mL of mineral water swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
11332761|NCT03501069|BG004|Baseline|Japanese Cohort 5: Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11332762|NCT03501069|BG005|Baseline|Non-Japanese Cohort 2: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332763|NCT03501069|BG006|Baseline|Non-Japanese Cohort 3: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once daily for 10 days.
11217153|NCT02311309|BG000|Baseline|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11217154|NCT02311309|BG001|Baseline|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11217155|NCT02311309|BG002|Baseline|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
11217156|NCT02311309|BG003|Baseline|Total|Total of all reporting groups
11217157|NCT02311309|FG000|Participant Flow|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11217158|NCT02311309|FG001|Participant Flow|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11217159|NCT02311309|FG002|Participant Flow|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
11217160|NCT02311309|OG000|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11217161|NCT02311309|OG001|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11217162|NCT02311309|OG002|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
11217163|NCT02311309|EG000|Reported Event|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11217164|NCT02311309|EG001|Reported Event|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11217165|NCT02311309|EG002|Reported Event|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
11217166|NCT02311361|BG000|Baseline|Durvalumab + 8 Gray (Gy) in 1 Fraction|"Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217167|NCT02311361|BG001|Baseline|Durvalumab +5 Gy in 5 Fractions|"Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217168|NCT02311361|BG002|Baseline|Durvalumab +Tremelimumab + 8 Gy in 1 Fraction|"Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217169|NCT02311361|BG003|Baseline|Durvalumab +Tremelimumab +5 Gy in 5 Fractions|"Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217170|NCT02311361|BG004|Baseline|Total|Total of all reporting groups
11217171|NCT02311361|FG000|Participant Flow|Durvalumab + 8 Gray (Gy) in 1 Fraction|"Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217172|NCT02311361|FG001|Participant Flow|Durvalumab +5 Gy in 5 Fractions|"Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217173|NCT02311361|FG002|Participant Flow|Durvalumab +Tremelimumab + 8 Gy in 1 Fraction|"Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217174|NCT02311361|FG003|Participant Flow|Durvalumab +Tremelimumab +5 Gy in 5 Fractions|"Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217175|NCT02311361|OG000|Outcome|Cohort A Dose Level A1|"Durvalumab + 8 Gray (Gy) in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217176|NCT02311361|OG001|Outcome|Cohort A Dose Level A2|"Durvalumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11332764|NCT03501069|BG007|Baseline|Non-Japanese Cohort 4: TAK-418 160 mg|TAK-418 160 mg, capsule, orally, once daily for 10 days.
11217177|NCT02311361|OG002|Outcome|Cohort C Dose Level C1|"Durvalumab +Tremelimumab + 8 Gy in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217178|NCT02311361|OG003|Outcome|Cohort C Dose Level C2|"Durvalumab +Tremelimumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217179|NCT02311361|OG000|Outcome|Durvalumab + 8 Gray (Gy) in 1 Fraction|"Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217180|NCT02311361|OG001|Outcome|Durvalumab +5 Gy in 5 Fractions|"Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217181|NCT02311361|OG002|Outcome|Durvalumab +Tremelimumab + 8 Gy in 1 Fraction|"Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217182|NCT02311361|OG003|Outcome|Durvalumab +Tremelimumab +5 Gy in 5 Fractions|"Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217183|NCT02311361|EG000|Reported Event|Durvalumab + 8 Gray (Gy) in 1 Fraction|"Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217184|NCT02311361|EG001|Reported Event|Durvalumab +5 Gy in 5 Fractions|"Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217185|NCT02311361|EG002|Reported Event|Durvalumab +Tremelimumab + 8 Gy in 1 Fraction|"Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217186|NCT02311361|EG003|Reported Event|Durvalumab +Tremelimumab +5 Gy in 5 Fractions|"Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions~Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.~Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks~Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5"
11217191|NCT02311881|BG000|Baseline|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217192|NCT02311881|BG001|Baseline|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217193|NCT02311881|BG002|Baseline|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217194|NCT02311881|BG003|Baseline|Total|Total of all reporting groups
11217195|NCT02311881|FG000|Participant Flow|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 milligram (mg) sustained release (SR) tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 milliliter [mL]) of water/dose for 12 weeks.
11332765|NCT03501069|BG008|Baseline|Japanese Cohort 5: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332766|NCT03501069|BG009|Baseline|Total|Total of all reporting groups
11297604|NCT03005041|FG001|Participant Flow|Mineral Water/Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing followed by with 15mL of experimental oral rinse/mouth wash swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
11297605|NCT03005041|OG000|Outcome|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
11297606|NCT03005041|OG001|Outcome|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
11297607|NCT03005041|EG000|Reported Event|Experimental Oral Rinse|Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental mouth wash use was permitted.
11297608|NCT03005041|EG001|Reported Event|Mineral Water|Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
11297609|NCT03005054|BG000|Baseline|StrataGraft Skin Tissue|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound."
11297610|NCT03005054|FG000|Participant Flow|StrataGraft Skin Tissue|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound."
11297611|NCT03005054|OG000|Outcome|StrataGraft Skin Tissue|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound."
11297612|NCT03005054|EG000|Reported Event|StrataGraft Skin Tissue|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound."
11297613|NCT03005067|BG000|Baseline|Test Product|Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).
11297614|NCT03005067|BG001|Baseline|Placebo Nasal Spray|Participants were administered placebo nasal spray containing vehicle without carbomer 980.
11297615|NCT03005067|BG002|Baseline|Total|Total of all reporting groups
11297616|NCT03005067|FG000|Participant Flow|Test Product|Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).
11297617|NCT03005067|FG001|Participant Flow|Placebo Nasal Spray|Participants were administered placebo nasal spray containing vehicle without carbomer 980.
11297618|NCT03005067|OG000|Outcome|Test Product|Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).
11297619|NCT03005067|OG001|Outcome|Placebo Nasal Spray|Participants were administered placebo nasal spray containing vehicle without carbomer 980.
11297620|NCT03005067|EG000|Reported Event|Test Product|Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).
11297621|NCT03005067|EG001|Reported Event|Placebo Nasal Spray|Participants were administered placebo nasal spray containing vehicle without carbomer 980.
11297622|NCT03005106|BG000|Baseline|All Participants|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound."
11297623|NCT03005106|FG000|Participant Flow|All Participants|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound."
11297624|NCT03005106|OG000|Outcome|All Participants|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound."
11297625|NCT03005106|EG000|Reported Event|All Participants|"StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).~Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound."
11297626|NCT03005288|BG000|Baseline|BYM338 10 mg/kg|intravenous infusion every four weeks
11297627|NCT03005288|BG001|Baseline|Placebo|intravenous infusion every four weeks
11297628|NCT03005288|BG002|Baseline|Total|Total of all reporting groups
11297629|NCT03005288|FG000|Participant Flow|BYM338 10 mg/kg|intravenous infusion every four weeks
11297630|NCT03005288|FG001|Participant Flow|Placebo|intravenous infusion every four weeks
11297631|NCT03005288|OG000|Outcome|BYM338 10 mg/kg|intravenous infusion every four weeks
11297632|NCT03005288|OG001|Outcome|Placebo|intravenous infusion every four weeks
10971374|NCT00915356|FG000|Participant Flow|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
10971375|NCT00915356|FG001|Participant Flow|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
10971376|NCT00915356|FG002|Participant Flow|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
10971377|NCT00915356|FG003|Participant Flow|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
10971378|NCT00915356|FG004|Participant Flow|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
10971379|NCT00915356|OG000|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
10971380|NCT00915356|OG001|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
10971381|NCT00915356|OG002|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
10971382|NCT00915356|OG003|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
10971383|NCT00915356|OG004|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
10971384|NCT00915356|EG000|Reported Event|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
10971385|NCT00915356|EG001|Reported Event|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
10971386|NCT00915356|EG002|Reported Event|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
10971387|NCT00915356|EG003|Reported Event|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
11297633|NCT03005288|EG000|Reported Event|BYM338 10 mg/kg|intravenous infusion every four weeks
11297634|NCT03005288|EG001|Reported Event|Placebo|intravenous infusion every four weeks
11297635|NCT03006341|BG000|Baseline|Dabigatran Etexilate|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran etexilate between October 2010 and December 2014.
11297636|NCT03006341|BG001|Baseline|Warfarin|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate warfarin between October 2010 and December 2014.
11297637|NCT03006341|BG002|Baseline|Rivaroxaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate rivaroxaban between October 2010 and December 2014.
11297638|NCT03006341|BG003|Baseline|Apixaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate apixaban between October 2010 and December 2014.
11297639|NCT03006341|BG004|Baseline|Total|Total of all reporting groups
11297640|NCT03006341|FG000|Participant Flow|Dabigatran Etexilate|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran etexilate between October 2010 and December 2014.
11297641|NCT03006341|FG001|Participant Flow|Warfarin|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate warfarin between October 2010 and December 2014.
11332767|NCT03501069|FG000|Participant Flow|Non-Japanese Cohort 1: TAK-418 120 mg + Placebo|TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.
11332768|NCT03501069|FG001|Participant Flow|Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg|TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
10842977|NCT00251004|EG002|Reported Event|Control Group|"1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
10842978|NCT00251225|BG000|Baseline|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
10842979|NCT00251225|FG000|Participant Flow|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
10842980|NCT00251225|OG000|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
10842981|NCT00251225|EG000|Reported Event|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
10842982|NCT00251238|BG000|Baseline|Intervention Group|active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
10842983|NCT00251238|BG001|Baseline|Control Group|Receiving matching placebo
10842984|NCT00251238|BG002|Baseline|Total|Total of all reporting groups
10842985|NCT00251238|FG000|Participant Flow|Intervention Group|active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
10842986|NCT00251238|FG001|Participant Flow|Placebo Group|receiving matching placebo
10842987|NCT00251238|OG000|Outcome|Intervention Group|active treatment group (EGb 761)
10842988|NCT00251238|OG001|Outcome|Placebo Group|receiving placebo
10842989|NCT00251238|EG000|Reported Event|Intervention Group|active treatment group (EGb 761)
10842990|NCT00251238|EG001|Reported Event|Placebo Group|receiving placebo
10842991|NCT00251303|BG000|Baseline|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
10842992|NCT00251303|BG001|Baseline|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
10842993|NCT00251303|BG002|Baseline|Total|Total of all reporting groups
10842994|NCT00251303|FG000|Participant Flow|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
10842995|NCT00251303|FG001|Participant Flow|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
10842996|NCT00251303|OG000|Outcome|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
10842997|NCT00251303|OG001|Outcome|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
10842998|NCT00251303|OG000|Outcome|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
10842999|NCT00251303|OG001|Outcome|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
10848342|NCT00289731|BG001|Baseline|Engerix-B+Havrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11297642|NCT03006341|FG002|Participant Flow|Rivaroxaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate rivaroxaban between October 2010 and December 2014.
11297643|NCT03006341|FG003|Participant Flow|Apixaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate apixaban between October 2010 and December 2014.
11297644|NCT03006341|OG000|Outcome|Dabigatran Etexilate|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran etexilate between October 2010 and December 2014.
11297645|NCT03006341|OG001|Outcome|Warfarin|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate warfarin between October 2010 and December 2014.
11297646|NCT03006341|EG000|Reported Event|Dabigatran Etexilate|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran etexilate between October 2010 and December 2014.
11297647|NCT03006341|EG001|Reported Event|Warfarin|Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate warfarin between October 2010 and December 2014.
11297648|NCT03006341|EG002|Reported Event|Rivaroxaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate rivaroxaban between October 2010 and December 2014.
11297649|NCT03006341|EG003|Reported Event|Apixaban|(Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate apixaban between October 2010 and December 2014.
11297650|NCT03006393|BG000|Baseline|Infliximab|Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
11297651|NCT03006393|BG001|Baseline|Placebo|Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
11297652|NCT03006393|BG002|Baseline|Total|Total of all reporting groups
11297653|NCT03006393|FG000|Participant Flow|Infliximab|Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
11297654|NCT03006393|FG001|Participant Flow|Placebo|Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
10971388|NCT00915356|EG004|Reported Event|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
11297655|NCT03006393|OG000|Outcome|Infliximab|Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
11297656|NCT03006393|OG001|Outcome|Placebo|Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
11297657|NCT03006393|EG000|Reported Event|Infliximab|Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
11297658|NCT03006393|EG001|Reported Event|Placebo|Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
11297659|NCT03006458|BG000|Baseline|Overall Study|Total Participants
11297660|NCT03006458|FG000|Participant Flow|Comfilcon A Then Omafilcon B|"Participants were randomized to wear comfilcon A for two weeks during the cross over study.~comfilcon A: toric contact lens"
11297661|NCT03006458|FG001|Participant Flow|Omafilcon B Then Comfilcon A|"Participants were randomized to wear omafilcon B for two weeks during the cross over study.~omafilcon B: toric contact lens"
11297662|NCT03006458|OG000|Outcome|Comfilcon A|"Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.~comfilcon A: toric contact lens"
11297663|NCT03006458|OG001|Outcome|Omafilcon B|"Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.~omafilcon B: toric contact lens"
11297664|NCT03006458|EG000|Reported Event|Comfilcon A|"Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.~comfilcon A: toric contact lens"
11297665|NCT03006458|EG001|Reported Event|Omafilcon B|"Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.~omafilcon B: toric contact lens"
11297666|NCT03006471|BG000|Baseline|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11297667|NCT03006471|BG001|Baseline|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo - Cap: one per day before breakfast during 12 weeks."
11297668|NCT03006471|BG002|Baseline|Total|Total of all reporting groups
11297669|NCT03006471|FG000|Participant Flow|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11297670|NCT03006471|FG001|Participant Flow|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo - Cap: one per day before breakfast during 12 weeks."
11297671|NCT03006471|OG000|Outcome|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
10822249|NCT00075582|FG001|Participant Flow|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10848343|NCT00289731|BG002|Baseline|HB VAX PRO+Vaqta Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11297672|NCT03006471|OG001|Outcome|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo - Cap: one per day before breakfast during 12 weeks."
11297673|NCT03006471|EG000|Reported Event|Dapagliflozin|"Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.~Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks."
11297674|NCT03006471|EG001|Reported Event|Placebo|"Placebo capsules, one per day before breakfast during 12 weeks.~Placebo - Cap: one per day before breakfast during 12 weeks."
11297675|NCT03006562|BG000|Baseline|Subcutaneous Heparin|"Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.~Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital."
11297676|NCT03006562|BG001|Baseline|Control|Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
11297677|NCT03006562|BG002|Baseline|Total|Total of all reporting groups
11297678|NCT03006562|FG000|Participant Flow|Subcutaneous Heparin|"Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.~Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital."
11297679|NCT03006562|FG001|Participant Flow|Control|Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
11297680|NCT03006562|OG000|Outcome|Subcutaneous Heparin|"Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.~Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital."
11297681|NCT03006562|OG001|Outcome|Control|Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
11297682|NCT03006562|EG000|Reported Event|Subcutaneous Heparin|"Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.~Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital."
11297683|NCT03006562|EG001|Reported Event|Control|Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
11297684|NCT03006848|BG000|Baseline|Avelumab|"All participants with recurrent/refractory osteosarcoma who consent to the study.~Interventions: Avelumab and quality of life questionnaires.~Avelumab: Patients will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles.~Questionnaires: To assess quality of life, patients will complete questionnaires at four time points."
11297685|NCT03006848|FG000|Participant Flow|Avelumab|"All participants with recurrent/refractory osteosarcoma who consent to the study.~Interventions: Avelumab and quality of life questionnaires.~Avelumab: Patients will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles.~Questionnaires: To assess quality of life, patients will complete questionnaires at four time points."
11297686|NCT03006848|OG000|Outcome|Avelumab|"All participants with recurrent/refractory osteosarcoma who consent to the study.~Interventions: Avelumab and quality of life questionnaires.~Avelumab: Patients will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles.~Questionnaires: To assess quality of life, patients will complete questionnaires at four time points."
11297687|NCT03006848|OG000|Outcome|Progression-free Survival|The study is designed by treating RECIST response [complete response + partial response (CR+PR)] after 4-cycle treatment of avelumab and the 16-week progression-free survival (PFS) as dual binary endpoints. Patients who fail to be evaluated at the end of the 4-cycle will be counted as failure.
11297688|NCT03006848|OG000|Outcome|Target Toxicities|Target toxicities for avelumab treatment are defined as any grade 3-5 dyspnea, infusion-related reactions, or immune related adverse events at least possibly attributable to the agent observed anytime during the 26-cycle treatment period that a patient is on study (including the period between off treatment and off study).
11297689|NCT03006848|OG000|Outcome|Factors Associated With Response|Logistic regression analysis will be conducted to explore factors which may associate with response.
11297690|NCT03006848|OG000|Outcome|Change in Parameters of Immune Activation|Descriptive statistics will be provided.
11297691|NCT03006848|OG000|Outcome|Change in Cell Proliferation|Descriptive statistics will be provided.
11297692|NCT03006848|OG000|Outcome|Change in Co-inhibitory Receptor Expression on CD8 T Cells|Descriptive statistics will be provided.
11297693|NCT03006848|OG000|Outcome|Change in Quality of Life|Participants will self-report their quality of life through PROMIS questionnaires, either the Pediatric Profile (ages 8 to 17 years) or the Adult Profile (age 18 years or older). The change in age-normed T-scores will be reported. Mixed effect models will be performed to assess changes in quality of life over time.
11297694|NCT03006848|EG000|Reported Event|Avelumab|[Not specified]
11297695|NCT03006887|BG000|Baseline|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants with selected solid tumors received oral lenvatinib at a starting dose of 20 mg, capsule, once daily in combination with intravenous pembrolizumab 200 mg every 3 weeks on a 21-day treatment cycle to confirm the dose tolerability by assessing DLTs. In case of dose intolerability in Cycle 1, lenvatinib dose was reduced from 20 mg to 14 mg once daily, in combination with 200 mg pembrolizumab every 3 weeks administered up to maximum of 45 cycles or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study (31 months).
11332769|NCT03501069|FG002|Participant Flow|Non-Japanese Cohort 1: Placebo + TAK-418 160 mg|TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
11297696|NCT03006887|FG000|Participant Flow|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants with selected solid tumors received oral lenvatinib at a starting dose of 20 milligram (mg), capsule, once daily in combination with intravenous pembrolizumab 200 mg every 3 weeks on a 21-day treatment cycle to confirm the dose tolerability by assessing Dose limiting toxicities (DLTs). In case of dose intolerability in Cycle 1, lenvatinib dose was reduced from 20 mg to 14 mg once daily, in combination with 200 mg pembrolizumab every 3 weeks administered up to maximum of 45 cycles or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study (31 months).
11297697|NCT03006887|OG000|Outcome|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants with selected solid tumors received oral lenvatinib at a starting dose of 20 mg, capsule, once daily in combination with intravenous pembrolizumab 200 mg every 3 weeks on a 21-day treatment cycle to confirm the dose tolerability by assessing DLTs. In case of dose intolerability in Cycle 1, lenvatinib dose was reduced from 20 mg to 14 mg once daily, in combination with 200 mg pembrolizumab every 3 weeks administered up to maximum of 45 cycles or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study (31 months).
11297698|NCT03006887|EG000|Reported Event|Lenvatinib 20 mg Plus Pembrolizumab 200 mg|Participants with selected solid tumors received oral lenvatinib at a starting dose of 20 mg, capsule, once daily in combination with intravenous pembrolizumab 200 mg every 3 weeks on a 21-day treatment cycle to confirm the dose tolerability by assessing DLTs. In case of dose intolerability in Cycle 1, lenvatinib dose was reduced from 20 mg to 14 mg once daily, in combination with 200 mg pembrolizumab every 3 weeks administered up to maximum of 45 cycles or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study (31 months).
11297699|NCT03007225|BG000|Baseline|Group 1|"Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)~The procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.~Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan)."
11297700|NCT03007225|BG001|Baseline|Group 2|"Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique~TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.~Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved."
11297701|NCT03007225|BG002|Baseline|Total|Total of all reporting groups
11297702|NCT03007225|FG000|Participant Flow|Chemoembolization + Drug Eluting Beads|"Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)~TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.~Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter or 2.7F microcatheter"
11332770|NCT03501069|FG003|Participant Flow|Non-Japanese Cohorts 2 to 4: Pooled Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11332771|NCT03501069|FG004|Participant Flow|Japanese Cohort 5: Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
10822250|NCT00075582|OG000|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10822251|NCT00075582|OG001|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10848344|NCT00289731|BG003|Baseline|Total|Total of all reporting groups
10848345|NCT00289731|FG000|Participant Flow|Twinrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
11297703|NCT03007225|FG001|Participant Flow|Chemoembolization + Standard TACE Technique|"Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique~Trans-arterial chemoembolization (TACE): TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter . Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.~Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution.~Gel foam embolization was performed then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved."
11297704|NCT03007225|OG000|Outcome|Group 1|"Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)~TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.~Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter"
11297705|NCT03007225|OG001|Outcome|Group 2|"Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique~TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.~Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved."
11297706|NCT03007225|EG000|Reported Event|Group 1|"Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)~TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.~Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter"
11297707|NCT03007225|EG001|Reported Event|Group 2|"Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique~:TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.~Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performedand an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved."
11297708|NCT03007394|BG000|Baseline|Lorcaserin|"10 mg capsule by mouth, twice a day, for 13 weeks~Lorcaserin: Lorcaserin Capsule"
11297709|NCT03007394|BG001|Baseline|Placebo Oral Capsule|"10 mg placebo capsule, twice a day, for 13 weeks~Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule"
11297710|NCT03007394|BG002|Baseline|Total|Total of all reporting groups
11297711|NCT03007394|FG000|Participant Flow|Lorcaserin|"10 mg capsule by mouth, twice a day, for 13 weeks~Lorcaserin: Lorcaserin Capsule"
11297712|NCT03007394|FG001|Participant Flow|Placebo Oral Capsule|"10 mg placebo capsule, twice a day, for 13 weeks~Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule"
11297713|NCT03007394|OG000|Outcome|Lorcaserin|"10 mg capsule by mouth, twice a day, for 13 weeks~Lorcaserin: Lorcaserin Capsule"
11297714|NCT03007394|OG001|Outcome|Placebo Oral Capsule|"10 mg placebo capsule, twice a day, for 13 weeks~Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule"
11297715|NCT03007394|EG000|Reported Event|Lorcaserin|"10 mg capsule by mouth, twice a day, for 13 weeks~Lorcaserin: Lorcaserin Capsule"
11332772|NCT03501069|FG005|Participant Flow|Non-Japanese Cohort 2: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
10971389|NCT00915473|BG000|Baseline|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
11332773|NCT03501069|FG006|Participant Flow|Non-Japanese Cohort 3: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once daily for 10 days.
11332774|NCT03501069|FG007|Participant Flow|Non-Japanese Cohort 4: TAK-418 160 mg|TAK-418 160 mg, capsule, orally, once daily for 10 days.
11332775|NCT03501069|FG008|Participant Flow|Japanese Cohort 5: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332776|NCT03501069|OG000|Outcome|Non-Japanese Cohort 1; Period A: Placebo|TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
10971390|NCT00915473|BG001|Baseline|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
10971391|NCT00915473|BG002|Baseline|Total|Total of all reporting groups
11297716|NCT03007394|EG001|Reported Event|Placebo Oral Capsule|"10 mg placebo capsule, twice a day, for 13 weeks~Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule"
11297717|NCT03007472|BG000|Baseline|CI532/N7 Study Group|"All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor~CI532: Cochlear implant~Nucleus 7: Sound processor"
11297718|NCT03007472|FG000|Participant Flow|CI532/N7 Study Group|"All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor~CI532: Cochlear implant~Nucleus 7: Sound processor"
11297719|NCT03007472|OG000|Outcome|CI532/N7 Study Group|"All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor~CI532: Cochlear implant~Nucleus 7: Sound processor"
11297720|NCT03007472|EG000|Reported Event|CI532/N7 Study Group|"All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor~CI532: Cochlear implant~Nucleus 7: Sound processor"
11297721|NCT03007953|BG000|Baseline|Intervention|"This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).~Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols."
11297722|NCT03007953|BG001|Baseline|Usual Care|Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
11297723|NCT03007953|BG002|Baseline|Total|Total of all reporting groups
11297724|NCT03007953|FG000|Participant Flow|Intervention|"This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).~Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols."
11297725|NCT03007953|FG001|Participant Flow|Usual Care|Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
11297726|NCT03007953|OG000|Outcome|Intervention|"This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).~Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols."
11297727|NCT03007953|OG001|Outcome|Usual Care|Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
11297728|NCT03007953|EG000|Reported Event|Intervention|"This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).~Palliative Care: Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols."
11297729|NCT03007953|EG001|Reported Event|Usual Care|Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
11332777|NCT03501069|OG001|Outcome|Non-Japanese Cohort 1; Period B: Placebo|TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
11332778|NCT03501069|OG002|Outcome|Non-Japanese Cohort 1: TAK 418 120 mg|TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
11332779|NCT03501069|OG003|Outcome|Non-Japanese Cohort 1: TAK 418 160 mg|TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
11332780|NCT03501069|OG000|Outcome|Non-Japanese Cohorts 2 to 4: Pooled Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11332781|NCT03501069|OG001|Outcome|Japanese Cohort 5: Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11297730|NCT03007966|BG000|Baseline|Ilioinguinal / Iliohypogastric Block|"Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique."
11332782|NCT03501069|OG002|Outcome|Non-Japanese Cohort 2: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332783|NCT03501069|OG003|Outcome|Non-Japanese Cohort 3: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once daily for 10 days.
11332784|NCT03501069|OG004|Outcome|Non-Japanese Cohort 4: TAK-418 160 mg|TAK-418 160 mg, capsule, orally, once daily for 10 days.
11332785|NCT03501069|OG005|Outcome|Japanese Cohort 5: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332786|NCT03501069|OG000|Outcome|Non-Japanese Cohort 1: TAK 418 120 mg|TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
11332787|NCT03501069|OG001|Outcome|Non-Japanese Cohort 1: TAK 418 160 mg|TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
11332788|NCT03501069|OG000|Outcome|Non-Japanese Cohort 2: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332789|NCT03501069|OG001|Outcome|Non-Japanese Cohort 3: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once daily for 10 days.
11332790|NCT03501069|OG002|Outcome|Non-Japanese Cohort 4: TAK-418 160 mg|TAK-418 160 mg, capsule, orally, once daily for 10 days.
11332791|NCT03501069|OG003|Outcome|Japanese Cohort 5: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332792|NCT03501069|EG000|Reported Event|Non-Japanese Cohort 1; Period A: Placebo|TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
11332793|NCT03501069|EG001|Reported Event|Non-Japanese Cohort 1; Period B: Placebo|TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
11332794|NCT03501069|EG002|Reported Event|Non-Japanese Cohort 1: TAK 418 120 mg|TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
11332795|NCT03501069|EG003|Reported Event|Non-Japanese Cohort 1: TAK 418 160 mg|TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
11332796|NCT03501069|EG004|Reported Event|Non-Japanese Cohorts 2 to 4: Pooled Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11332797|NCT03501069|EG005|Reported Event|Japanese Cohort 5: Placebo|TAK-418 placebo-matching capsule, orally, once daily for 10 days.
11332798|NCT03501069|EG006|Reported Event|Non-Japanese Cohort 2: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332799|NCT03501069|EG007|Reported Event|Non-Japanese Cohort 3: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once daily for 10 days.
11332800|NCT03501069|EG008|Reported Event|Non-Japanese Cohort 4: TAK-418 160 mg|TAK-418 160 mg, capsule, orally, once daily for 10 days.
11332801|NCT03501069|EG009|Reported Event|Japanese Cohort 5: TAK-418 20 mg|TAK-418 20 mg, capsule, orally, once daily for 10 days.
11332802|NCT03501264|BG000|Baseline|Intervention Group|"This group receives the game~Online Game: LGBTQ Bullying game"
11332803|NCT03501264|BG001|Baseline|Control Group|"This group receives LGBTQ resources only~LGBTQ Resources: This group receives LGBTQ Resources"
11332804|NCT03501264|BG002|Baseline|Total|Total of all reporting groups
11332805|NCT03501264|FG000|Participant Flow|Intervention Group|"This group receives the game~Online Game: LGBTQ Bullying game"
11332806|NCT03501264|FG001|Participant Flow|Control Group|"This group receives LGBTQ resources only~LGBTQ Resources: This group receives LGBTQ Resources"
11332807|NCT03501264|OG000|Outcome|Intervention Group|"This group receives the game~Online Game: LGBTQ Bullying game"
11332808|NCT03501264|OG001|Outcome|Control Group|"This group receives LGBTQ resources only~LGBTQ Resources: This group receives LGBTQ Resources"
11332809|NCT03501264|EG000|Reported Event|Intervention Group|"This group receives the game~Online Game: LGBTQ Bullying game"
11332810|NCT03501264|EG001|Reported Event|Control Group|"This group receives LGBTQ resources only~LGBTQ Resources: This group receives LGBTQ Resources"
11332811|NCT03501277|BG000|Baseline|Sequence I: ABCD|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) fixed dose combination (FDC) tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
11332812|NCT03501277|BG001|Baseline|Sequence II: BCDA|Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
11332813|NCT03501277|BG002|Baseline|Sequence III: CDAB|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
11297731|NCT03007966|BG001|Baseline|Quadratus Lumborum Block|"Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.~Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c"
11297732|NCT03007966|BG002|Baseline|Total|Total of all reporting groups
11297733|NCT03007966|FG000|Participant Flow|Ilioinguinal / Iliohypogastric Block|"Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique."
11297734|NCT03007966|FG001|Participant Flow|Quadratus Lumborum Block|"Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.~Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c"
11297735|NCT03007966|OG000|Outcome|Ilioinguinal / Iliohypogastric Block|"Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique."
11297736|NCT03007966|OG001|Outcome|Quadratus Lumborum Block|"Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.~Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c"
11297737|NCT03007966|OG001|Outcome|Quadratus Lumborum Block|"Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.~Bupivacaine 0.25%: Administered as part of the local anesthetic mixture~Epinephrine 1:200k: Administered as part of the local anesthetic mixture~Clonidine 1.66mcg/c"
10848346|NCT00289731|FG001|Participant Flow|Engerix-B+Havrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11297738|NCT03007966|EG000|Reported Event|Ilioinguinal / Iliohypogastric Block|"Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique."
11297739|NCT03007966|EG001|Reported Event|Quadratus Lumborum Block|"Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.~Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.~Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c"
11297740|NCT03008070|BG000|Baseline|IVA337 1200mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 1200mg"
11297741|NCT03008070|BG001|Baseline|IVA337 800mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 800mg"
11297742|NCT03008070|BG002|Baseline|Placebo|"Placebo to match, once a day (Quaque Die, QD) with food~Placebo: Placebo to match"
11297743|NCT03008070|BG003|Baseline|Total|Total of all reporting groups
11297744|NCT03008070|FG000|Participant Flow|Lanifibranor 1200mg|"Lanifibranor 400mg, once a day (Quaque Die, QD) with food~Lanifibranor: 1200mg"
11297745|NCT03008070|FG001|Participant Flow|Lanifibranor 800mg|"Lanifibranor 400mg, once a day (Quaque Die, QD) with food~Lanifibranor: 800mg"
11297746|NCT03008070|FG002|Participant Flow|Placebo|"Placebo to match, once a day (Quaque Die, QD) with food~Placebo: Placebo to match"
11297747|NCT03008070|OG000|Outcome|IVA337 1200mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 1200mg"
11297748|NCT03008070|OG001|Outcome|IVA337 800mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 800mg"
11297749|NCT03008070|OG002|Outcome|Placebo|"Placebo to match, once a day (Quaque Die, QD) with food~Placebo: Placebo to match"
11297750|NCT03008070|OG000|Outcome|Lanifibranor 1200mg|"Lanifibranor 400mg, once a day (Quaque Die, QD) with food~Lanifibranor: 1200mg"
11297751|NCT03008070|OG001|Outcome|Lanifibranor 800mg|"Lanifibranor 400mg, once a day (Quaque Die, QD) with food~Lanifibranor: 800mg"
11297752|NCT03008070|EG000|Reported Event|IVA337 1200mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 1200mg"
11297753|NCT03008070|EG001|Reported Event|IVA337 800mg|"IVA337 400mg, once a day (Quaque Die, QD) with food~IVA337: 800mg"
11297754|NCT03008070|EG002|Reported Event|Placebo|"Placebo to match, once a day (Quaque Die, QD) with food~Placebo: Placebo to match"
11297755|NCT03008174|BG000|Baseline|Intervention|"Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.~Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later."
11297756|NCT03008174|BG001|Baseline|Control|"Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care."
11297757|NCT03008174|BG002|Baseline|Total|Total of all reporting groups
11297758|NCT03008174|FG000|Participant Flow|Intervention|"Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.~Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later."
11297759|NCT03008174|FG001|Participant Flow|Control|"Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care."
11336349|NCT03565315|FG001|Participant Flow|Group 2: 10E8VLS (5 mg/kg) SC Multiple Dose Group* (*Only One Dose Received)|"10E8VLS (5 mg/kg) administered by the SC route (Day 0, Week 12*, Week 24*)~*Participants received only one product administration on Day 0 because of the voluntary study pause and termination by the IND Sponsor/PI decision.~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1."
11336350|NCT03565315|FG002|Participant Flow|Group 3: 10E8VLS+VRC07-523LS (5 mg/kg Each) SC Single Dose Group|"10E8VLS (5 mg/kg)+VRC07-523LS (5 mg/kg) administered by the SC route (Day 0)~VRC-HIVMAB095-00-AB (10E8VLS): 10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.~VRC-HIVMAB075-00-AB (VRC07-523LS): VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11217196|NCT02311881|FG001|Participant Flow|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217197|NCT02311881|FG002|Participant Flow|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217198|NCT02311881|OG000|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
10848347|NCT00289731|FG002|Participant Flow|HB VAX PRO+Vaqta Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11217199|NCT02311881|OG001|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217200|NCT02311881|OG002|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217201|NCT02311881|OG000|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
11217202|NCT02311881|OG001|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
11217203|NCT02311881|OG002|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
11217204|NCT02311881|EG000|Reported Event|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217205|NCT02311881|EG001|Reported Event|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217206|NCT02311881|EG002|Reported Event|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
11217207|NCT02311894|BG000|Baseline|Somatropin|Children will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
11217208|NCT02311894|FG000|Participant Flow|Somatropin|Children will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
11217209|NCT02311894|OG000|Outcome|Somatropin|Children will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
11217210|NCT02311894|EG000|Reported Event|Somatropin|Children will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
11217211|NCT02311907|BG000|Baseline|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11217212|NCT02311907|BG001|Baseline|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
11217213|NCT02311907|BG002|Baseline|Total|Total of all reporting groups
11217214|NCT02311907|FG000|Participant Flow|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11217215|NCT02311907|FG001|Participant Flow|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
11217216|NCT02311907|OG000|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
11217217|NCT02311907|OG001|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
11217218|NCT02311907|EG000|Reported Event|A (Glutathione, Carboplatin)|Quality-of-Life Assessment: Ancillary studies
11217219|NCT02311907|EG001|Reported Event|B (Placebo, Paclitaxel)|Quality-of-Life Assessment: Ancillary studies
10971392|NCT00915473|FG000|Participant Flow|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
11217220|NCT02311933|BG000|Baseline|Arm I (Z-endoxifen Hydrochloride)|Patients receive 80 mg z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11217221|NCT02311933|BG001|Baseline|Arm II (Tamoxifen Citrate)|Patients receive 20 mg tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
11217222|NCT02311933|BG002|Baseline|Total|Total of all reporting groups
11217223|NCT02311933|FG000|Participant Flow|Arm I (Z-endoxifen Hydrochloride)|Patients receive 80 mg z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11217224|NCT02311933|FG001|Participant Flow|Arm II (Tamoxifen Citrate)|Patients receive 20 mg tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
11217225|NCT02311933|OG000|Outcome|Arm I (Z-endoxifen Hydrochloride)|Patients receive 80 mg z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11217226|NCT02311933|OG001|Outcome|Arm II (Tamoxifen Citrate)|Patients receive 20 mg tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
11217227|NCT02311933|EG000|Reported Event|Arm I (Z-endoxifen Hydrochloride)|Patients receive 80 mg z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11217228|NCT02311933|EG001|Reported Event|Arm II (Tamoxifen Citrate)|Patients receive 20 mg tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
11217229|NCT02311972|BG000|Baseline|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study.
11217230|NCT02311972|BG001|Baseline|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database.
11217231|NCT02311972|BG002|Baseline|Total|Total of all reporting groups
11217232|NCT02311972|FG000|Participant Flow|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
11217233|NCT02311972|FG001|Participant Flow|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
11217234|NCT02311972|OG000|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
11297760|NCT03008174|OG000|Outcome|Intervention|"Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.~Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later."
11297761|NCT03008174|OG001|Outcome|Control|"Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care."
11297762|NCT03008174|EG000|Reported Event|Intervention|"Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.~Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later."
11297763|NCT03008174|EG001|Reported Event|Control|"Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.~Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care."
11297764|NCT03008213|BG000|Baseline|Netupitant and Palonosetron|"Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.~Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron"
11297765|NCT03008213|FG000|Participant Flow|Netupitant and Palonosetron|"Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.~Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron"
11297766|NCT03008213|OG000|Outcome|Netupitant and Palonosetron|"Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.~Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron"
11297767|NCT03008213|EG000|Reported Event|Netupitant and Palonosetron|"Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.~Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron"
11297768|NCT03008460|BG000|Baseline|Eziclen®/Izinova®|Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
11297769|NCT03008460|BG001|Baseline|Klean-Prep®|Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
11297770|NCT03008460|BG002|Baseline|Total|Total of all reporting groups
11297771|NCT03008460|FG000|Participant Flow|Eziclen®/Izinova®|Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
11297772|NCT03008460|FG001|Participant Flow|Klean-Prep®|Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
11297773|NCT03008460|OG000|Outcome|Eziclen®/Izinova®|Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
11297774|NCT03008460|OG001|Outcome|Klean-Prep®|Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
11217235|NCT02311972|OG001|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
11217236|NCT02311972|OG000|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
11217237|NCT02311972|EG000|Reported Event|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
11217238|NCT02311972|EG001|Reported Event|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
11217239|NCT02312063|BG000|Baseline|Sitagliptin|Sitagliptin 50 mg a day for 16 weeks
11217240|NCT02312063|BG001|Baseline|Glimepiride|Glimepiride 0.5 mg a day for 16 weeks
11217241|NCT02312063|BG002|Baseline|Total|Total of all reporting groups
11217242|NCT02312063|FG000|Participant Flow|Sitagliptin|"Sitagliptin 50 mg a day for 16 weeks~Sitagliptin"
11217243|NCT02312063|FG001|Participant Flow|Glimepiride|"Glimepiride 0.5 mg a day for 16 weeks~Glimepiride"
11217244|NCT02312063|OG000|Outcome|Sitagliptin|The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected.
11217245|NCT02312063|OG001|Outcome|Glimepiride|The participants started glimepiride and continued the 16-week intervention with all pre-defined data collected.
11217246|NCT02312063|OG000|Outcome|Sitagliptin|The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected
11217247|NCT02312063|EG000|Reported Event|Sitagliptin|The participants started sitagliptin at week 0
11217248|NCT02312063|EG001|Reported Event|Glimepiride|The participants started glimepiride at week 0
11217249|NCT02312154|BG000|Baseline|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11217250|NCT02312154|FG000|Participant Flow|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11217251|NCT02312154|OG000|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11217252|NCT02312154|OG001|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11217253|NCT02312154|EG000|Reported Event|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11217254|NCT02312206|BG000|Baseline|NEOD001 (24 mg/kg) + Standard of Care|NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
11217255|NCT02312206|BG001|Baseline|Placebo + Standard of Care|Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
11217256|NCT02312206|BG002|Baseline|Total|Total of all reporting groups
11217257|NCT02312206|FG000|Participant Flow|NEOD001 (24 mg/kg) + Standard of Care|NEOD001, 24 mg/kg IV every 28 days on top of standard of care until completion of 156 primary endpoints
11217258|NCT02312206|FG001|Participant Flow|Placebo + Standard of Care|Placebo, 0.9% Saline IV every 28 days on top of standard of care until completion of 156 primary endpoints
11217259|NCT02312206|OG000|Outcome|NEOD001 (24 mg/kg) + Standard of Care|NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
11217260|NCT02312206|OG001|Outcome|Placebo + Standard of Care|Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
11217261|NCT02312206|EG000|Reported Event|NEOD001 (24 mg/kg) + Standard of Care|NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
10971393|NCT00915473|FG001|Participant Flow|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
10971394|NCT00915473|OG000|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
10971395|NCT00915473|OG001|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
10971396|NCT00915473|EG000|Reported Event|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
10971397|NCT00915473|EG001|Reported Event|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
11217262|NCT02312206|EG001|Reported Event|Placebo + Standard of Care|Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
10971398|NCT00915499|BG000|Baseline|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
10971399|NCT00915499|BG001|Baseline|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
10971400|NCT00915499|BG002|Baseline|Total|Total of all reporting groups
10971401|NCT00915499|FG000|Participant Flow|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
11217263|NCT02312219|BG000|Baseline|Low Dose Methotrexate|"Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.~Folic Acid: 1 mg folic acid once daily~Low Dose Methotrexate: An anti-inflammatory drug"
11217264|NCT02312219|BG001|Baseline|Placebo|"Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.~Folic Acid: 1 mg folic acid once daily~Placebo: placebo once weekly"
11217265|NCT02312219|BG002|Baseline|Total|Total of all reporting groups
11217266|NCT02312219|FG000|Participant Flow|Low Dose Methotrexate|"Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.~Folic Acid: 1 mg folic acid once daily~Low Dose Methotrexate: An anti-inflammatory drug"
11217267|NCT02312219|FG001|Participant Flow|Placebo|"Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.~Folic Acid: 1 mg folic acid once daily~Placebo: placebo once weekly"
11217268|NCT02312219|OG000|Outcome|Low Dose Methotrexate|"Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.~Folic Acid: 1 mg folic acid once daily~Low Dose Methotrexate: An anti-inflammatory drug"
11217269|NCT02312219|OG001|Outcome|Placebo|"Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.~Folic Acid: 1 mg folic acid once daily~Placebo: placebo once weekly"
11217270|NCT02312219|EG000|Reported Event|Low Dose Methotrexate|"Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.~Folic Acid: 1 mg folic acid once daily~Low Dose Methotrexate: An anti-inflammatory drug"
11217271|NCT02312219|EG001|Reported Event|Placebo|"Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.~Folic Acid: 1 mg folic acid once daily~Placebo: placebo once weekly"
11217272|NCT02312310|BG000|Baseline|0 mg|daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
11217273|NCT02312310|BG001|Baseline|260 mg|daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
11217274|NCT02312310|BG002|Baseline|510 mg|daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
11217275|NCT02312310|BG003|Baseline|770 mg|daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
11217276|NCT02312310|BG004|Baseline|Total|Total of all reporting groups
11217277|NCT02312310|FG000|Participant Flow|0 mg Cocoa Flavanol|daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
11217278|NCT02312310|FG001|Participant Flow|260 mg Cocoa Flavanol|daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
11297775|NCT03008460|EG000|Reported Event|Eziclen®/Izinova®|Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
11297776|NCT03008460|EG001|Reported Event|Klean-Prep®|Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
11297777|NCT03008590|BG000|Baseline|Naltrexone First|Received naltrexone first, then placebo
11297778|NCT03008590|BG001|Baseline|Placebo First|Received placebo first, then naltrexone
11297779|NCT03008590|BG002|Baseline|Total|Total of all reporting groups
11297780|NCT03008590|FG000|Participant Flow|Naltrexone First Then Placebo|"Naltrexone for 8 weeks, then placebo for 8 weeks, blinded cross-over design~Naltrexone: One 4.5 mg capsule each evening~Placebo: One capsule each evening"
11297781|NCT03008590|FG001|Participant Flow|Placebo First Then Naltrexone|"Placebo for 8 weeks, then naltrexone for 8 weeks, blinded cross-over design~Naltrexone: One 4.5 mg capsule each evening~Placebo: One capsule each evening"
11297782|NCT03008590|OG000|Outcome|At End of 8 Weeks Naltrexone Treatment|Data from naltrexone periods were pooled for presentation purposes, but period (first or second) was included as a variable in the statistical analysis. Results shown are change from baseline.
11297783|NCT03008590|OG001|Outcome|At End of 8 Weeks Placebo Treatment|Data from naltrexone periods were pooled for presentation purposes, but period (first or second) was included as a variable in the statistical analysis. Results shown are change from baseline.
11297784|NCT03008590|EG000|Reported Event|During Naltrexone Treatment|Adverse events during naltrexone
11297785|NCT03008590|EG001|Reported Event|During Placebo Treatment|Adverse events during placebo
11297786|NCT03008707|BG000|Baseline|Laparoscopic Peritoneal Lavage|"Patients who undergo Laparoscopic Peritoneal Lavage~Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites"
11297787|NCT03008707|BG001|Baseline|Laparoscopically Approached Sigmoidectomy|Patients who have a laparoscopically approached sigmoidectomy
11297788|NCT03008707|BG002|Baseline|Total|Total of all reporting groups
11297789|NCT03008707|FG000|Participant Flow|Laparoscopic Peritoneal Lavage|"Patients who undergo Laparoscopic Peritoneal Lavage~Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites"
11297790|NCT03008707|FG001|Participant Flow|Laparoscopically Approached Sigmoidectomy|Patients who have a laparoscopically approached sigmoidectomy
10848348|NCT00289731|OG000|Outcome|Twinrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
10848349|NCT00289731|OG001|Outcome|Engerix-B+Havrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11297791|NCT03008707|OG000|Outcome|Laparoscopic Peritoneal Lavage|"Patients who undergo Laparoscopic Peritoneal Lavage~Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites"
11297792|NCT03008707|OG001|Outcome|Laparoscopically Approached Sigmoidectomy|Patients who have a laparoscopically approached sigmoidectomy
11297793|NCT03008707|EG000|Reported Event|Laparoscopic Peritoneal Lavage|"Patients who undergo Laparoscopic Peritoneal Lavage~Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites"
11297794|NCT03008707|EG001|Reported Event|Laparoscopically Approached Sigmoidectomy|Patients who have a laparoscopically approached sigmoidectomy
11297795|NCT03008837|BG000|Baseline|PENFS|Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
11297796|NCT03008837|BG001|Baseline|Standard Therapy|"Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist."
11297797|NCT03008837|BG002|Baseline|Total|Total of all reporting groups
11297798|NCT03008837|FG000|Participant Flow|PENFS|"Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military"
11297799|NCT03008837|FG001|Participant Flow|Standard Therapy|"Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist."
11297800|NCT03008837|OG000|Outcome|PENFS (Post-pre)|Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS). This column shows the number of voxels in clusters that showed increased or decreased connectivity following treatment, >40 voxel clusters, thresholded at p<0.05 in AFNI.
11297801|NCT03008837|OG001|Outcome|Standard Therapy Control (Post-pre)|Veterans with fibromyalgia who meet study criteria and are randomized to the control group will receive standard therapy including medications and physical therapy. This column shows the number of voxels in clusters that showed increased or decreased connectivity following standard therapy, >40 voxel clusters, thresholded at p<0.05 in AFNI.
11297802|NCT03008837|OG000|Outcome|PENFS|"Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military"
11297803|NCT03008837|OG001|Outcome|Standard Therapy|"Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist."
11297804|NCT03008837|OG000|Outcome|PENFS|Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
11297805|NCT03008837|EG000|Reported Event|PENFS|Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
11297806|NCT03008837|EG001|Reported Event|Standard Therapy|"Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.~Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist."
11297807|NCT03008889|BG000|Baseline|Participants Taking NAC|"Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.~N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297808|NCT03008889|BG001|Baseline|Participants Taking Placebo|"Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.~Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297809|NCT03008889|BG002|Baseline|Total|Total of all reporting groups
11297810|NCT03008889|FG000|Participant Flow|Participants Taking NAC|"Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.~N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297811|NCT03008889|FG001|Participant Flow|Participants Taking Placebo|"Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.~Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297812|NCT03008889|OG000|Outcome|Participants Taking NAC|"Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.~N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.~In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.~If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63."
11297813|NCT03008889|OG001|Outcome|Participants Taking Placebo|"Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.~Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.~In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.~If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63."
11297814|NCT03008889|OG000|Outcome|Consented Participants Before Randomization|Participants consented in the trial, before randomization.
11297815|NCT03008889|EG000|Reported Event|Participants Taking NAC|"Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.~N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297816|NCT03008889|EG001|Reported Event|Participants Taking Placebo|"Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.~Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
11297817|NCT03008915|BG000|Baseline|Overall Study|Baseline characteristics reported for all 15 participants in the crossover study.
11297818|NCT03008915|FG000|Participant Flow|Aspirin First, Then Placebo|"Aspirin 81mg for 2 weeks followed by a washout period and then placebo for 2 weeks~Aspirin: 81mg aspirin taken once per day in the morning~Placebo: placebo taken once per day in the morning~Withdrawal from alpha1 antitrypsin replacement therapy: After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized."
11297819|NCT03008915|FG001|Participant Flow|Placebo First, Then Aspirin|"Placebo for 2 weeks followed by a washout period and then aspirin 81mg for 2 weeks~Aspirin: 81mg aspirin taken once per day in the morning~Placebo: placebo taken once per day in the morning~Withdrawal from alpha1 antitrypsin replacement therapy: After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized."
11297820|NCT03008915|OG000|Outcome|Aspirin|Assessment on aspirin 81mg for 2 weeks.
11297821|NCT03008915|OG001|Outcome|Placebo|Assessment on placebo for 2 weeks.
11297822|NCT03008915|OG000|Outcome|Off Alpha-1 Replacement Therapy|Assessment after 5 weeks off alpha-1 replacement therapy
11297823|NCT03008915|EG000|Reported Event|Aspirin|Assessment on aspirin 81mg for 2 weeks.
11297824|NCT03008915|EG001|Reported Event|Placebo|Assessment on placebo for 2 weeks.
11297825|NCT03009162|BG000|Baseline|Healthy Participants|Participants received single 200 milligrams (mg) oral dose of lasmiditan.
11297826|NCT03009162|BG001|Baseline|Renal Impaired Participants|Participants received single 200 mg oral dose of lasmiditan.
11297827|NCT03009162|BG002|Baseline|Total|Total of all reporting groups
11297828|NCT03009162|FG000|Participant Flow|Healthy Participants|Participants received single 200 milligrams (mg) oral dose of lasmiditan.
11297829|NCT03009162|FG001|Participant Flow|Renal Impaired Participants|Participants received single 200 mg oral dose of lasmiditan.
11297830|NCT03009162|OG000|Outcome|Healthy Participants|Participants received single 200 mg oral dose of lasmiditan.
11297831|NCT03009162|OG001|Outcome|Renal Impaired Participants|Participants received single 200 mg oral dose of lasmiditan.
11297832|NCT03009162|EG000|Reported Event|Healthy Participants|Participants received single 200 mg oral dose of lasmiditan.
11297833|NCT03009162|EG001|Reported Event|Renal Impaired Participants|Participants received single 200 mg oral dose of lasmiditan.
11297834|NCT03009396|BG000|Baseline|RHB-104|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine.
11297835|NCT03009396|FG000|Participant Flow|RHB-104 From RHB-104|RHB-104 (fixed-dose combination 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study.
11297836|NCT03009396|FG001|Participant Flow|RHB-104 From Placebo|RHB-104 (fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
11297837|NCT03009396|OG000|Outcome|RHB-104 From ACTIVE Arm of RHB-104-01|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
11297838|NCT03009396|OG001|Outcome|RHB-104 From PLACEBO Arm of RHB-104-01|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
11297839|NCT03009396|OG001|Outcome|RHB-104 From PLACEBO Arm of RHB-104-01|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
11297840|NCT03009396|EG000|Reported Event|RHB-104 From RHB-104|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study.
11297841|NCT03009396|EG001|Reported Event|RHB-104 From Placebo|RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
11297842|NCT03010137|BG000|Baseline|Standard Closure|"After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).~Standard Closure with Skin Glue~Dermabond: Final wound closure with skin glue."
11297843|NCT03010137|BG001|Baseline|Incisional Negative Pressure Wound Therapy|"After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.~Incisional Negative Pressure Wound Therapy~PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister."
11297844|NCT03010137|BG002|Baseline|Total|Total of all reporting groups
11297845|NCT03010137|FG000|Participant Flow|Standard Closure|"After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).~Standard Closure with Skin Glue~Dermabond: Final wound closure with skin glue."
11297846|NCT03010137|FG001|Participant Flow|Incisional Negative Pressure Wound Therapy|"After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.~Incisional Negative Pressure Wound Therapy~PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister."
11297847|NCT03010137|OG000|Outcome|Standard Closure|"After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).~Standard Closure with Skin Glue~Dermabond: Final wound closure with skin glue."
11297848|NCT03010137|OG001|Outcome|Incisional Negative Pressure Wound Therapy|"After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.~Incisional Negative Pressure Wound Therapy~PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister."
11297849|NCT03010137|EG000|Reported Event|Standard Closure|"After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).~Standard Closure with Skin Glue~Dermabond: Final wound closure with skin glue."
11297850|NCT03010137|EG001|Reported Event|Incisional Negative Pressure Wound Therapy|"After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.~Incisional Negative Pressure Wound Therapy~PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister."
11297851|NCT03010254|BG000|Baseline|DFT015|ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
11297852|NCT03010254|BG001|Baseline|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11297853|NCT03010254|BG002|Baseline|Total|Total of all reporting groups
11297854|NCT03010254|FG000|Participant Flow|DFT015|ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
11297855|NCT03010254|FG001|Participant Flow|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11297856|NCT03010254|OG000|Outcome|DFT015|ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
11297857|NCT03010254|OG001|Outcome|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11297858|NCT03010254|OG000|Outcome|DFT015 First Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
11297859|NCT03010254|OG001|Outcome|DFT015 Second Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
11297860|NCT03010254|EG000|Reported Event|Preoperative|All subjects in the safety analysis set prior to initiation of treatment
11297861|NCT03010254|EG001|Reported Event|DFT015 First Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
11297862|NCT03010254|EG002|Reported Event|DFT015 Second Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
11297863|NCT03010254|EG003|Reported Event|DFT015 Systemic|All subjects with attempted test article implantation (successful or aborted after contact with the eye)
11297864|NCT03010254|EG004|Reported Event|SN60WF First Eye|All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye
11297865|NCT03010254|EG005|Reported Event|SN60WF Second Eye|All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye
11297866|NCT03010254|EG006|Reported Event|SN60WF Systemic|All subjects with attempted control article implantation (successful or aborted after contact with the eye)
11297867|NCT03010462|BG000|Baseline|Active|"Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation~Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy"
11297868|NCT03010462|BG001|Baseline|Control|"Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation~Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy"
11297869|NCT03010462|BG002|Baseline|Total|Total of all reporting groups
11297870|NCT03010462|FG000|Participant Flow|Active|"Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation~Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy"
11297871|NCT03010462|FG001|Participant Flow|Control|"Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation~Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy"
11297872|NCT03010462|OG000|Outcome|Active|"Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation~Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy"
11297873|NCT03010462|OG001|Outcome|Control|"Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation~Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy"
11297874|NCT03010462|EG000|Reported Event|Active|"Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation~Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy"
11297875|NCT03010462|EG001|Reported Event|Control|"Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation~Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy"
11297876|NCT03010488|BG000|Baseline|Rapid Sleep Shift|"Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297877|NCT03010488|BG001|Baseline|Gradual Sleep Shift|"Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297878|NCT03010488|BG002|Baseline|Total|Total of all reporting groups
11297879|NCT03010488|FG000|Participant Flow|Rapid Sleep Shift|"Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297880|NCT03010488|FG001|Participant Flow|Gradual Sleep Shift|"Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297881|NCT03010488|OG000|Outcome|Rapid Sleep Shift|"Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297882|NCT03010488|OG001|Outcome|Gradual Sleep Shift|"Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297883|NCT03010488|EG000|Reported Event|Rapid Sleep Shift|"Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297884|NCT03010488|EG001|Reported Event|Gradual Sleep Shift|"Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.~Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.~Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.~Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy"
11297885|NCT03010501|BG000|Baseline|All Study Participants|Enrolled participants who completed the trial and whose data was not excluded from analysis
11297886|NCT03010501|FG000|Participant Flow|80% Food Energy Density First, Then 100%, Then 120%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 100%, then 120%.
11297887|NCT03010501|FG001|Participant Flow|100% Food Energy Density First, Then 120%, Then 80%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 120%, then 80%.
11297888|NCT03010501|FG002|Participant Flow|120% Food Energy Density First, Then 80%, Then 100%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 80%, then 100%.
11297889|NCT03010501|FG003|Participant Flow|80% Food Energy Density First, Then 120%, Then 100%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 120%, then 100%.
11297890|NCT03010501|FG004|Participant Flow|100% Food Energy Density, Then 80%, Then 120%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 80%, then 120%.
11297891|NCT03010501|FG005|Participant Flow|120% Food Energy Density, Then 100%, Then 80%|Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 100%, then 80%.
11297892|NCT03010501|OG000|Outcome|100% Food Energy Density|"Baseline Food Energy Density~Food Energy Density: Food Energy density manipulated"
11297893|NCT03010501|OG001|Outcome|80% Food Energy Density|"Lower Food Energy Density~Food Energy Density: Food Energy density manipulated"
11297894|NCT03010501|OG002|Outcome|120% Food Energy Density|"Higher Food Energy Density~Food Energy Density: Food Energy density manipulated"
11297895|NCT03010501|EG000|Reported Event|80% Food Energy Density|All participants during the 80% Food Energy Density intervention
11297896|NCT03010501|EG001|Reported Event|100% Food Energy Density|All participants during the 100% Food Energy Density intervention
11297897|NCT03010501|EG002|Reported Event|120% Food Energy Density|All participants during the 120% Food Energy Density intervention
11297898|NCT03010527|BG000|Baseline|Bimekizumab 64 mg Q4W|Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.
11297899|NCT03010527|BG001|Baseline|Bimekizumab 160 mg Q4W|Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.
11297900|NCT03010527|BG002|Baseline|Bimekizumab 320 mg Q4W|Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
11297901|NCT03010527|BG003|Baseline|Total Title|
11297902|NCT03010527|FG000|Participant Flow|Bimekizumab 64 mg Q4W|Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.
11297903|NCT03010527|FG001|Participant Flow|Bimekizumab 160 mg Q4W|Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.
10971402|NCT00915499|FG001|Participant Flow|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
11297904|NCT03010527|FG002|Participant Flow|Bimekizumab 320 mg Q4W|Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
10971403|NCT00915499|OG000|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
10971404|NCT00915499|OG001|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
10971405|NCT00915499|EG000|Reported Event|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
10971406|NCT00915499|EG001|Reported Event|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
11217279|NCT02312310|FG002|Participant Flow|510 mg Cocoa Flavanol|daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
11217280|NCT02312310|FG003|Participant Flow|770 mg Cocoa Flavanol|daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
11217281|NCT02312310|OG000|Outcome|0 mg Cocoa Flavanol|daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
11217282|NCT02312310|OG001|Outcome|260 mg Cocoa Flavanol|daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
11217283|NCT02312310|OG002|Outcome|510 mg Cocoa Flavanol|daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
11217284|NCT02312310|OG003|Outcome|770 mg Cocoa Flavanol|daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
11217285|NCT02312310|OG000|Outcome|0 mg|daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
11217286|NCT02312310|OG001|Outcome|260 mg|daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
11217287|NCT02312310|OG002|Outcome|510 mg|daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
11217288|NCT02312310|OG003|Outcome|770 mg|daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
11217289|NCT02312310|EG000|Reported Event|0 mg Cocoa Flavanol|daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
11217290|NCT02312310|EG001|Reported Event|260 mg Cocoa Flavanol|daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
11217291|NCT02312310|EG002|Reported Event|510 mg Cocoa Flavanol|daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
11217292|NCT02312310|EG003|Reported Event|770 mg Cocoa Flavanol|daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
11217293|NCT02312622|BG000|Baseline|Cohort A - Pegylated Irinotecan to Treat NSCLC|"Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217294|NCT02312622|BG001|Baseline|Cohort B - Pegylated Irinotecan to Treat SCLC|"Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217295|NCT02312622|BG002|Baseline|Cohort C - Pegylated Irinotecan to Treat mBC|"Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217296|NCT02312622|BG003|Baseline|Total|Total of all reporting groups
11217297|NCT02312622|FG000|Participant Flow|Cohort A - Pegylated Irinotecan to Treat NSCLC|"Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217298|NCT02312622|FG001|Participant Flow|Cohort B - Pegylated Irinotecan to Treat SCLC|"Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217299|NCT02312622|FG002|Participant Flow|Cohort C - Pegylated Irinotecan to Treat mBC|"Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217300|NCT02312622|OG000|Outcome|Cohort A - Pegylated Irinotecan to Treat NSCLC|"Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217301|NCT02312622|OG001|Outcome|Cohort C - Pegylated Irinotecan to Treat mBC|"Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217302|NCT02312622|OG001|Outcome|Cohort C - Pegylated Irinotecan to Treat mBC|"Cohort C - Pegylated Irinotecan to treat mBC Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217303|NCT02312622|OG000|Outcome|Cohort B - Pegylated Irinotecan to Treat SCLC|"Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217304|NCT02312622|OG001|Outcome|Cohort B - Pegylated Irinotecan to Treat SCLC|"Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11297905|NCT03010527|OG000|Outcome|Bimekizumab 64 mg Q4W (SS)|Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).
11297906|NCT03010527|OG001|Outcome|Bimekizumab 160 mg Q4W (SS)|Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.
11297907|NCT03010527|OG002|Outcome|Bimekizumab 320 mg Q4W (SS)|Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
11297908|NCT03010527|OG000|Outcome|Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)|Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).
11297909|NCT03010527|OG001|Outcome|Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)|Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.
11297910|NCT03010527|OG002|Outcome|Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)|Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
11297911|NCT03010527|OG003|Outcome|Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)|Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
11297912|NCT03010527|OG004|Outcome|Placebo/Bimekizumab 160 mg Q4W/NR (FAS)|Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.
11297913|NCT03010527|OG005|Outcome|Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)|Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.
11297914|NCT03010527|OG006|Outcome|Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)|Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
11297915|NCT03010527|OG007|Outcome|Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)|Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
11297916|NCT03010527|OG008|Outcome|Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)|Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
11297917|NCT03010527|EG000|Reported Event|Bimekizumab 64 mg Q4W (SS)|Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).
11297918|NCT03010527|EG001|Reported Event|Bimekizumab 160 mg Q4W (SS)|Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.
11297919|NCT03010527|EG002|Reported Event|Bimekizumab 320 mg Q4W (SS)|Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
11297920|NCT03010631|BG000|Baseline|Cohort 1: Treatment A Then Treatment B|Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days
11297921|NCT03010631|BG001|Baseline|Cohort 1: Treatment B Then Treatment A|Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days
11297922|NCT03010631|BG002|Baseline|Cohort 2: Treatment C Then Treatment D|Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days
11297923|NCT03010631|BG003|Baseline|Cohort 2: Treatment D Then Treatment C|Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days
11297924|NCT03010631|BG004|Baseline|Total|Total of all reporting groups
11217305|NCT02312622|OG002|Outcome|Cohort C - Pegylated Irinotecan to Treat mBC|"Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217306|NCT02312622|EG000|Reported Event|Cohort A - Pegylated Irinotecan to Treat NSCLC|"Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217307|NCT02312622|EG001|Reported Event|Cohort B - Pegylated Irinotecan to Treat SCLC|"Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217308|NCT02312622|EG002|Reported Event|Cohort C - Pegylated Irinotecan to Treat mBC|"Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.~Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)"
11217309|NCT02312687|BG000|Baseline|KRN23|KRN23 SC injections every 4 weeks
11217310|NCT02312687|FG000|Participant Flow|KRN23|KRN23 subcutaneous (SC) injections every 4 weeks
11217311|NCT02312687|OG000|Outcome|KRN23|KRN23 SC injections every 4 weeks
11217312|NCT02312687|EG000|Reported Event|KRN23|KRN23 SC injections every 4 weeks
11217313|NCT02312713|BG000|Baseline|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
11217314|NCT02312713|BG001|Baseline|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
11217315|NCT02312713|BG002|Baseline|Wait List Control|no intervention
11217316|NCT02312713|BG003|Baseline|Total|Total of all reporting groups
11217317|NCT02312713|FG000|Participant Flow|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
11217318|NCT02312713|FG001|Participant Flow|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
11217319|NCT02312713|FG002|Participant Flow|Wait List Control|no intervention
11217320|NCT02312713|OG000|Outcome|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
11297925|NCT03010631|FG000|Participant Flow|Cohort 1: Treatment A Then Treatment B|Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days
10848350|NCT00289731|OG002|Outcome|HB VAX PRO+Vaqta Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
10971407|NCT00915525|BG000|Baseline|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11297926|NCT03010631|FG001|Participant Flow|Cohort 1: Treatment B Then Treatment A|Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days
11297927|NCT03010631|FG002|Participant Flow|Cohort 2: Treatment C Then Treatment D|Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days
11297928|NCT03010631|FG003|Participant Flow|Cohort 2: Treatment D Then Treatment C|Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days
11297929|NCT03010631|OG000|Outcome|Treatment A: Lubiprostone Capsule, Fasted|Participants in the pharmacokinetic-evaluable (PK) population who received treatment A
11297930|NCT03010631|OG001|Outcome|Treatment B: Sprinkle Formulation, Fasted|Participants in the PK population who received treatment B
11297931|NCT03010631|OG000|Outcome|Treatment A: Lubiprostone Capsule, Fasted|Cohort 1 participants who received Treatment A
11297932|NCT03010631|OG001|Outcome|Treatment B: Sprinkle Formulation, Fasted|Cohort 1 participants who received Treatment B
11297933|NCT03010631|OG000|Outcome|Treatment C: Sprinkle Formulation, Fed|Cohort 2 participants who received Treatment C
11297934|NCT03010631|OG001|Outcome|Treatment D: Sprinkle Formulation, Fasted|Cohort 2 participants who received Treatment D
11297935|NCT03010631|OG002|Outcome|Treatment C: Sprinkle Formulation, Fed|Cohort 2 participants who received Treatment C
11297936|NCT03010631|OG003|Outcome|Treatment D: Sprinkle Formulation, Fasted|Cohort 2 participants who received Treatment D
11297937|NCT03010631|EG000|Reported Event|Treatment A|All participants who received lubiprostone 2x24 μg capsule once orally.
11297938|NCT03010631|EG001|Reported Event|Treatment B|All participants who received lubiprostone 2x24 μg sprinkle formulation once orally.
10971408|NCT00915525|BG001|Baseline|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11297939|NCT03010631|EG002|Reported Event|Treatment C|All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fed conditions.
11297940|NCT03010631|EG003|Reported Event|Treatment D|All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fasted conditions.
11297941|NCT03010683|BG000|Baseline|Liraglutide|Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection
11297942|NCT03010683|BG001|Baseline|Metformin|Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
10971409|NCT00915525|BG002|Baseline|Total|Total of all reporting groups
10971410|NCT00915525|FG000|Participant Flow|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11297943|NCT03010683|BG002|Baseline|Total|Total of all reporting groups
11297944|NCT03010683|FG000|Participant Flow|Liraglutide|Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection
11297945|NCT03010683|FG001|Participant Flow|Metformin|Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
11297946|NCT03010683|OG000|Outcome|Liraglutide|Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection
11297947|NCT03010683|OG001|Outcome|Metformin|Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
11297948|NCT03010683|EG000|Reported Event|Liraglutide|Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection
11297949|NCT03010683|EG001|Reported Event|Metformin|Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
11297950|NCT03010800|BG000|Baseline|With Yoni.Fit First|With the Yoni.Fit first, then without the Yoni.Fit.
11297951|NCT03010800|BG001|Baseline|Without Yoni.Fit First|Without the Yoni.Fit first, then with the Yoni.Fit.
11297952|NCT03010800|BG002|Baseline|Total|Total of all reporting groups
11297953|NCT03010800|FG000|Participant Flow|With Yoni.Fit First|Yoni.Fit first, then without the Yoni.Fit.
11297954|NCT03010800|FG001|Participant Flow|Without Yoni.Fit First|Without Yoni.Fit first, then with Yoni.Fit.
11297955|NCT03010800|OG000|Outcome|With Yoni.Fit|Pad weights for with the Yoni.Fit
11297956|NCT03010800|OG001|Outcome|Without Yoni.Fit|Pad weights without Yoni.Fit.
11297957|NCT03010800|EG000|Reported Event|With Yoni.Fit|Those subjects assigned to use the Yoni.Fit first
11297958|NCT03010800|EG001|Reported Event|Without Yoni.Fit|Those subjects assigned to use the pad first.
11297959|NCT03011099|BG000|Baseline|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
11297960|NCT03011099|BG001|Baseline|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
11297961|NCT03011099|BG002|Baseline|Total|Total of all reporting groups
11297962|NCT03011099|FG000|Participant Flow|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
11297963|NCT03011099|FG001|Participant Flow|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
11297964|NCT03011099|OG000|Outcome|Robotic Exoskeleton Training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
11297965|NCT03011099|OG001|Outcome|Conventional Physical Therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
11297966|NCT03011099|OG000|Outcome|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
11297967|NCT03011099|OG001|Outcome|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
11297968|NCT03011099|EG000|Reported Event|Robotic Exoskeleton Training|Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
11297969|NCT03011099|EG001|Reported Event|Conventional Physical Therapy|Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
11297970|NCT03011333|BG000|Baseline|Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
11297971|NCT03011333|BG001|Baseline|Group 2: HTX-011|HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
11297972|NCT03011333|BG002|Baseline|Group 3: HTX-011|HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
11297973|NCT03011333|BG003|Baseline|Group 4: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
11297974|NCT03011333|BG004|Baseline|Group 5: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
11297975|NCT03011333|BG005|Baseline|Group 6: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg via nerve block
11297976|NCT03011333|BG006|Baseline|Group 7: Saline Placebo|Saline placebo via nerve block
11297977|NCT03011333|BG007|Baseline|Total|Total of all reporting groups
11297978|NCT03011333|FG000|Participant Flow|Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
11297979|NCT03011333|FG001|Participant Flow|Group 2: HTX-011|HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
11297980|NCT03011333|FG002|Participant Flow|Group 3: HTX-011|HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
11297981|NCT03011333|FG003|Participant Flow|Group 4: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
11297982|NCT03011333|FG004|Participant Flow|Group 5: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
11297983|NCT03011333|FG005|Participant Flow|Group 6: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg via nerve block
11297984|NCT03011333|FG006|Participant Flow|Group 7: Saline Placebo|Saline placebo via nerve block
11297985|NCT03011333|OG000|Outcome|Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
11297986|NCT03011333|OG001|Outcome|Group 2: HTX-011|HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
11297987|NCT03011333|OG002|Outcome|Group 3: HTX-011|HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
11297988|NCT03011333|OG003|Outcome|Group 4: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
11297989|NCT03011333|OG004|Outcome|Group 5: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
11297990|NCT03011333|OG005|Outcome|Group 6: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg via nerve block
11297991|NCT03011333|OG006|Outcome|Group 7: Saline Placebo|Saline placebo via nerve block
11297992|NCT03011333|EG000|Reported Event|Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
11297993|NCT03011333|EG001|Reported Event|Group 2: HTX-011|HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
11217321|NCT02312713|OG001|Outcome|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
11217322|NCT02312713|OG002|Outcome|Wait List Control|no intervention
11217323|NCT02312713|EG000|Reported Event|Standard Physical Therapy|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.~Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises."
11217324|NCT02312713|EG001|Reported Event|Internet Based Exercise Training|"Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.~Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
11217325|NCT02312713|EG002|Reported Event|Wait List Control|no intervention
11217326|NCT02312726|BG000|Baseline|Total Participants Enrolled in Study|Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
11217327|NCT02312726|FG000|Participant Flow|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217328|NCT02312726|FG001|Participant Flow|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217329|NCT02312726|FG002|Participant Flow|Excluded|Participants who did not meet inclusion criteria or declined after consent.
11217330|NCT02312726|OG000|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217331|NCT02312726|OG001|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217332|NCT02312726|OG000|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217333|NCT02312726|EG000|Reported Event|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217334|NCT02312726|EG001|Reported Event|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11217335|NCT02312739|BG000|Baseline|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11217336|NCT02312739|BG001|Baseline|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11217337|NCT02312739|BG002|Baseline|Total|Total of all reporting groups
11297994|NCT03011333|EG002|Reported Event|Group 3: HTX-011|HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
11297995|NCT03011333|EG003|Reported Event|Group 4: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
11297996|NCT03011333|EG004|Reported Event|Group 5: HTX-011|HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
11297997|NCT03011333|EG005|Reported Event|Group 6: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg via nerve block
11297998|NCT03011333|EG006|Reported Event|Group 7: Saline Placebo|Saline placebo via nerve block
11297999|NCT03011840|BG000|Baseline|Pre Intervention|"In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.~Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed."
11298000|NCT03011840|BG001|Baseline|Post Intervention|"In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.~Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia"
11298001|NCT03011840|BG002|Baseline|Total|Total of all reporting groups
11298002|NCT03011840|FG000|Participant Flow|Pre Intervention|"In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.~Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed."
11298003|NCT03011840|FG001|Participant Flow|Post Intervention|"In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.~Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia"
11298004|NCT03011840|OG000|Outcome|Pre Intervention|"In the first part planned over 2months (Jan - Feb), feedback forms will be collected from patients at the end of minor OT procedure. The number of postponement or rescheduling of cases will be noted.~Postponement or rescheduling of case is defined as an event when the patient who is called for his turn in minor OT is deferred for any amount of time in account of starvation not adequate, investigations not brought, medications not taken as prescribed."
11298005|NCT03011840|OG001|Outcome|Post Intervention|"In the intervention phase, the patient information leaflet (PIL) will be handed over to all patients planned for procedure in the minor OT complex. This leaflet will be handed over by the attending doctor in the Head neck OPD. The checklist pertaining to counselling at the Head neck OPD will be ticked after they are carried out. The patient will be instructed to read leaflet carefully and carry the leaflet on the day of Minor OT procedure. In the minor OT the discharge checklist in the PIL would be carried out by all concerned including the surgical, anesthesia and nursing team. The impact of use of PIL will be assessed by noting the number of postponement or rescheduling of cases.~Information leaflet: Patient information leaflet with instructions to be carried out before procedure under general anesthesia"
11298006|NCT03011840|EG000|Reported Event|Pre Intervention|prior to introduction of patient information leaflet
11298007|NCT03011840|EG001|Reported Event|Post Intervention|after introduction of patient information leaflet
11298008|NCT03011892|BG000|Baseline|Double Blind (DB): Vehicle BID|Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
11298009|NCT03011892|BG001|Baseline|DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
11298010|NCT03011892|BG002|Baseline|DB: Ruxolitinib 0.15% Once Daily (QD)|Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
11298011|NCT03011892|BG003|Baseline|DB : Ruxolitinib 0.5% QD|Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
11298012|NCT03011892|BG004|Baseline|DB : Ruxolitinib 1.5% QD|Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
11298013|NCT03011892|BG005|Baseline|DB : Ruxolitinib 1.5% Cream Twice Daily (BID)|Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
11298014|NCT03011892|BG006|Baseline|Total|Total of all reporting groups
11298015|NCT03011892|FG000|Participant Flow|Double Blind (DB): Vehicle BID|Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
11298016|NCT03011892|FG001|Participant Flow|DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
11298017|NCT03011892|FG002|Participant Flow|DB: Ruxolitinib 0.15% Once Daily (QD)|Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
11298018|NCT03011892|FG003|Participant Flow|DB: Ruxolitinib 0.5% QD|Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
11298019|NCT03011892|FG004|Participant Flow|DB: Ruxolitinib 1.5% QD|Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
11298020|NCT03011892|FG005|Participant Flow|DB: Ruxolitinib 1.5% BID|Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
11298021|NCT03011892|FG006|Participant Flow|Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298022|NCT03011892|FG007|Participant Flow|OL: TAC BID/ Vehicle BID to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298023|NCT03011892|FG008|Participant Flow|OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298024|NCT03011892|FG009|Participant Flow|OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298025|NCT03011892|FG010|Participant Flow|OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298026|NCT03011892|FG011|Participant Flow|OL: Ruxolitinib 1.5% Cream BID for 8 Weeks in DB Period.|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298027|NCT03011892|OG000|Outcome|DB: Vehicle BID|Participants applied vehicle cream BID for 8 weeks in DB period.
11298028|NCT03011892|OG001|Outcome|DB: Ruxolitinib 1.5% BID|Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
11298029|NCT03011892|OG001|Outcome|DB: Ruxolitinib 0.15% QD|Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
11298030|NCT03011892|OG002|Outcome|DB: Ruxolitinib 0.5% QD|Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
11298031|NCT03011892|OG003|Outcome|DB: Ruxolitinib 1.5% QD|Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
11298032|NCT03011892|OG000|Outcome|DB: TAC 0.1% BID/Vehicle Cream BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
11298033|NCT03011892|OG004|Outcome|DB: Ruxolitinib 1.5% BID|Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
11298034|NCT03011892|OG001|Outcome|DB: TAC 0.1% BID/Vehicle Cream BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
11298035|NCT03011892|OG002|Outcome|DB: Ruxolitinib 0.15% QD|Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
11298036|NCT03011892|OG003|Outcome|DB: Ruxolitinib 0.5% QD|Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
11298037|NCT03011892|OG004|Outcome|DB: Ruxolitinib 1.5% QD|Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
11298038|NCT03011892|OG005|Outcome|DB: Ruxolitinib 1.5% BID|Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
11298039|NCT03011892|OG001|Outcome|DB: TAC 0.1% BID/ Vehicle BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
11298040|NCT03011892|OG006|Outcome|OL: Vehicle BID to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
11298041|NCT03011892|OG007|Outcome|OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298042|NCT03011892|OG008|Outcome|OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298043|NCT03011892|OG009|Outcome|OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298044|NCT03011892|OG010|Outcome|OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298045|NCT03011892|OG011|Outcome|OL: Ruxolitinib 1.5% BID|Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298046|NCT03011892|EG000|Reported Event|Vehicle BID|Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
11298047|NCT03011892|EG001|Reported Event|Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID|Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
11298048|NCT03011892|EG002|Reported Event|INCB018424 0.15% QD|Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
11298049|NCT03011892|EG003|Reported Event|INCB018424 0.5% QD|Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
11298050|NCT03011892|EG004|Reported Event|INCB018424 1.5% QD|Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
11298051|NCT03011892|EG005|Reported Event|INCB018424 1.5% BID|Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
11298052|NCT03012061|BG000|Baseline|Placebo QD|Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298053|NCT03012061|BG001|Baseline|UMEC 31.25 mcg QD|Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298054|NCT03012061|BG002|Baseline|UMEC 62.5 mcg QD|Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298055|NCT03012061|BG003|Baseline|Total|Total of all reporting groups
11298056|NCT03012061|FG000|Participant Flow|Placebo QD|Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298057|NCT03012061|FG001|Participant Flow|UMEC 31.25 mcg QD|Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298058|NCT03012061|FG002|Participant Flow|UMEC 62.5 mcg QD|Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298059|NCT03012061|OG000|Outcome|Placebo QD|Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298060|NCT03012061|OG001|Outcome|UMEC 31.25 mcg QD|Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298061|NCT03012061|OG002|Outcome|UMEC 62.5 mcg QD|Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298062|NCT03012061|EG000|Reported Event|Placebo QD|Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298063|NCT03012061|EG001|Reported Event|UMEC 31.25 mcg QD|Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298064|NCT03012061|EG002|Reported Event|UMEC 62.5 mcg QD|Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks.
11298065|NCT03012191|BG000|Baseline|Topical Gentamicin|0.5% Gentamicin ointment
11298066|NCT03012191|BG001|Baseline|Intravenous Gentamicin|IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
11298067|NCT03012191|BG002|Baseline|Intradermal Gentamicin|0.5% Gentamicin ointment applied after microneedle roller assistance
11298068|NCT03012191|BG003|Baseline|Total|Total of all reporting groups
11298069|NCT03012191|FG000|Participant Flow|Topical Gentamicin|0.5% Gentamicin ointment
11298070|NCT03012191|FG001|Participant Flow|Intravenous Gentamicin|IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
11298071|NCT03012191|FG002|Participant Flow|Intradermal Gentamicin|0.5% Gentamicin ointment applied after microneedle roller assistance
11298072|NCT03012191|OG000|Outcome|Topical Gentamicin|0.5% Gentamicin ointment
11298073|NCT03012191|OG001|Outcome|Intravenous Gentamicin|IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
11298074|NCT03012191|OG002|Outcome|Intradermal Gentamicin|0.5% Gentamicin ointment applied after microneedle roller assistance
11298075|NCT03012191|OG000|Outcome|Intravenous Gentamicin|IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
11298076|NCT03012191|EG000|Reported Event|Topical Gentamicin|0.5% Gentamicin ointment
11298077|NCT03012191|EG001|Reported Event|Intravenous Gentamicin|IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
11298078|NCT03012191|EG002|Reported Event|Intradermal Gentamicin|0.5% Gentamicin ointment applied after microneedle roller assistance
11298079|NCT03012334|BG000|Baseline|Sequence 1|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 50 mg, Period 2: Lasmiditan 100 mg, Period 3: Placebo, Period 4: Lasmiditan 200 mg and Period 5: Alprazolam 1 mg"
11298080|NCT03012334|BG001|Baseline|Sequence 2|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg, Period 3: Lasmiditan 50 mg, Period 4: Alprazolam 1 mg and Period 5: Placebo"
11298081|NCT03012334|BG002|Baseline|Sequence 3|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 100 mg, Period 4: Placebo and Period 5: Lasmiditan 50 mg"
11298082|NCT03012334|BG003|Baseline|Sequence 4|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Alprazolam 1 mg, Period 2: Placebo, Period 3: Lasmiditan 200 mg, Period 4: Lasmiditan 50 mg and Period 5: Lasmiditan 100 mg"
11298083|NCT03012334|BG004|Baseline|Sequence 5|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 50 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 200 mg"
11298084|NCT03012334|BG005|Baseline|Sequence 6|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Alprazolam 1 mg, Period 2: Lasmiditan 200 mg, Period 3: Placebo, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 50 mg"
11298085|NCT03012334|BG006|Baseline|Sequence 7|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Placebo, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 50 mg, Period 4: Lasmiditan 200 mg and Period 5: Lasmiditan 100 mg"
11298086|NCT03012334|BG007|Baseline|Sequence 8|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 50 mg, Period 2: Placebo, Period 3: Lasmiditan 100 mg, Period 4: Alprazolam 1 mg and Period 5: Lasmiditan 200 mg"
11298087|NCT03012334|BG008|Baseline|Sequence 9|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 50 mg, Period 3: Lasmiditan 200 mg, Period 4: Placebo and Period 5: Alprazolam 1 mg"
11298088|NCT03012334|BG009|Baseline|Sequence 10|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 50 mg and Period 5: Placebo"
11298089|NCT03012334|BG010|Baseline|Total|Total of all reporting groups
11298090|NCT03012334|FG000|Participant Flow|Sequence 1|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 50 mg, Period 2: Lasmiditan 100 mg, Period 3: Placebo, Period 4: Lasmiditan 200 mg and Period 5: Alprazolam 1 mg"
11298091|NCT03012334|FG001|Participant Flow|Sequence 2|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg, Period 3: Lasmiditan 50 mg, Period 4: Alprazolam 1 mg and Period 5: Placebo"
11298092|NCT03012334|FG002|Participant Flow|Sequence 3|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 100 mg, Period 4: Placebo and Period 5: Lasmiditan 50 mg"
11298093|NCT03012334|FG003|Participant Flow|Sequence 4|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Alprazolam 1 mg, Period 2: Placebo, Period 3: Lasmiditan 200 mg, Period 4: Lasmiditan 50 mg and Period 5: Lasmiditan 100 mg"
11298094|NCT03012334|FG004|Participant Flow|Sequence 5|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 50 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 200 mg"
11298095|NCT03012334|FG005|Participant Flow|Sequence 6|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Alprazolam 1 mg, Period 2: Lasmiditan 200 mg, Period 3: Placebo, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 50 mg"
11298096|NCT03012334|FG006|Participant Flow|Sequence 7|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Placebo, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 50 mg, Period 4: Lasmiditan 200 mg and Period 5: Lasmiditan 100 mg"
11298097|NCT03012334|FG007|Participant Flow|Sequence 8|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 50 mg, Period 2: Placebo, Period 3: Lasmiditan 100 mg, Period 4: Alprazolam 1 mg and Period 5: Lasmiditan 200 mg"
11298098|NCT03012334|FG008|Participant Flow|Sequence 9|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 50 mg, Period 3: Lasmiditan 200 mg, Period 4: Placebo and Period 5: Alprazolam 1 mg"
11298099|NCT03012334|FG009|Participant Flow|Sequence 10|"Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 50 mg and Period 5: Placebo"
11298100|NCT03012334|OG000|Outcome|Placebo|Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298101|NCT03012334|OG001|Outcome|Lasmiditan 50mg|Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298102|NCT03012334|OG002|Outcome|Lasmiditan 100mg|Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298103|NCT03012334|OG003|Outcome|Lasmiditan 200mg|Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298104|NCT03012334|OG004|Outcome|Alprazolam 1mg|Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298105|NCT03012334|OG004|Outcome|Alprazolam 1mg|Participants received 1mg Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298106|NCT03012334|EG000|Reported Event|Placebo|Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298107|NCT03012334|EG001|Reported Event|Lasmiditan 50mg|Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298108|NCT03012334|EG002|Reported Event|Lasmiditan 100mg|Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298109|NCT03012334|EG003|Reported Event|Lasmiditan 200mg|Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298110|NCT03012334|EG004|Reported Event|Alprazolam 1mg|Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
11298111|NCT03012477|BG000|Baseline|Cisplatin + AZD1775|"Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.~AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.~At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3)."
11298112|NCT03012477|FG000|Participant Flow|Cisplatin + AZD1775|"Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.~AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.~At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3)."
11298113|NCT03012477|OG000|Outcome|Cisplatin + AZD1775|"Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.~AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.~At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3)."
11298114|NCT03012477|EG000|Reported Event|Cisplatin + AZD1775|"Treatment will consist of one cycle of cisplatin monotherapy (cisplatin 75 mg/m2 IV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days(1 cycle) later.~AZD1775 will be administered 200 mg as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.~At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3)."
11298115|NCT03012594|BG000|Baseline|Lanreotide|"Open label~Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart"
11298116|NCT03012594|FG000|Participant Flow|Lanreotide|"Open label~Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart"
11298117|NCT03012594|OG000|Outcome|Lanreotide|"Open label~Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart"
11298118|NCT03012594|EG000|Reported Event|Lanreotide|"Open label~Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart"
11298119|NCT03012828|BG000|Baseline|Moxidectin 4mg|"10 subjects will receive a single oral dose of moxidectin 4mg~Moxidectin"
11298120|NCT03012828|BG001|Baseline|Moxidectin 8mg|"10 subjects will receive a single oral dose of moxidectin 8mg~Moxidectin"
11298121|NCT03012828|BG002|Baseline|Moxidectin 16mg|"10 subjects will receive a single oral dose of moxidectin 16mg~Moxidectin"
11298122|NCT03012828|BG003|Baseline|Moxidectin 24mg|"10 subjects will receive a single oral dose of moxidectin 24mg~Moxidectin"
11298123|NCT03012828|BG004|Baseline|Moxidectin 36mg|"10 subjects will receive a single oral dose of moxidectin 36mg~Moxidectin"
11298124|NCT03012828|BG005|Baseline|Placebo|"10 subjects will receive a single oral dose of placebo~Placebo"
11298125|NCT03012828|BG006|Baseline|Total|Total of all reporting groups
11298126|NCT03012828|FG000|Participant Flow|Moxidectin 4mg|"10 subjects will receive a single oral dose of moxidectin 4mg~Moxidectin"
11298127|NCT03012828|FG001|Participant Flow|Moxidectin 8mg|"10 subjects will receive a single oral dose of moxidectin 8mg~Moxidectin"
11298128|NCT03012828|FG002|Participant Flow|Moxidectin 16mg|"10 subjects will receive a single oral dose of moxidectin 16mg~Moxidectin"
11298129|NCT03012828|FG003|Participant Flow|Moxidectin 24mg|"10 subjects will receive a single oral dose of moxidectin 24mg~Moxidectin"
11298130|NCT03012828|FG004|Participant Flow|Moxidectin 36mg|"10 subjects will receive a single oral dose of moxidectin 36mg~Moxidectin"
11298131|NCT03012828|FG005|Participant Flow|Placebo|"10 subjects will receive a single oral dose of placebo~Placebo"
11298132|NCT03012828|OG000|Outcome|Moxidectin 4mg|"10 subjects will receive a single oral dose of moxidectin 4mg~Moxidectin"
11298133|NCT03012828|OG001|Outcome|Moxidectin 8mg|"10 subjects will receive a single oral dose of moxidectin 8mg~Moxidectin"
11298134|NCT03012828|OG002|Outcome|Moxidectin 16mg|"10 subjects will receive a single oral dose of moxidectin 16mg~Moxidectin"
11298135|NCT03012828|OG003|Outcome|Moxidectin 24mg|"10 subjects will receive a single oral dose of moxidectin 24mg~Moxidectin"
11298136|NCT03012828|OG004|Outcome|Moxidectin 36mg|"10 subjects will receive a single oral dose of moxidectin 36mg~Moxidectin"
11298137|NCT03012828|OG005|Outcome|Placebo|"10 subjects will receive a single oral dose of placebo~Placebo"
11298138|NCT03012828|OG006|Outcome|All Subjects|50 subjects received a single dose of between 4mg and 36mg of moxidectin. 10 subjects received a dose of placebo,
11298139|NCT03012828|OG006|Outcome|All Subjects|50 subjects received a single dose of moxidectin between 4mg and 36mg and 10 subjects received placebo
11298140|NCT03012828|EG000|Reported Event|Moxidectin 4mg|"10 subjects will receive a single oral dose of moxidectin 4mg~Moxidectin"
11298141|NCT03012828|EG001|Reported Event|Moxidectin 8mg|"10 subjects will receive a single oral dose of moxidectin 8mg~Moxidectin"
11298142|NCT03012828|EG002|Reported Event|Moxidectin 16mg|"10 subjects will receive a single oral dose of moxidectin 16mg~Moxidectin"
11298143|NCT03012828|EG003|Reported Event|Moxidectin 24mg|"10 subjects will receive a single oral dose of moxidectin 24mg~Moxidectin"
11298144|NCT03012828|EG004|Reported Event|Moxidectin 36mg|"10 subjects will receive a single oral dose of moxidectin 36mg~Moxidectin"
11298145|NCT03012828|EG005|Reported Event|Placebo|"10 subjects will receive a single oral dose of placebo~Placebo"
11298146|NCT03012841|BG000|Baseline|Modified Intent to Treat Group (mITT)|Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
11298147|NCT03012841|FG000|Participant Flow|Modified Intent to Treat (mITT) Group|Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
11298148|NCT03012841|FG001|Participant Flow|Not Treated|Subjects enrolled, but not treated with an Arctic Front Advance Cryoablation catheter.
11298149|NCT03012841|OG000|Outcome|Modified Intent to Treat Group (mITT)|Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
11298150|NCT03012841|OG000|Outcome|Treated 12-month Completers|Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter who had complete QoL questionnaires at baseline and follow-up
11298151|NCT03012841|EG000|Reported Event|Enrolled Subjects|All enrolled and consented subjects
11298152|NCT03013985|BG000|Baseline|Basal Bolus Insulin With Glargine U300 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U300: Glargine U300 is a new generation long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298153|NCT03013985|BG001|Baseline|Basal Bolus Insulin With Glargine U100 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U100: Glargine U100 is a long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298154|NCT03013985|BG002|Baseline|Total|Total of all reporting groups
11298155|NCT03013985|FG000|Participant Flow|Basal Bolus Insulin With Glargine U300 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U300: Glargine U300 is a new generation long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298156|NCT03013985|FG001|Participant Flow|Basal Bolus Insulin With Glargine U100 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U100: Glargine U100 is a long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298157|NCT03013985|OG000|Outcome|Basal Bolus Insulin With Glargine U300 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U300: Glargine U300 is a new generation long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298158|NCT03013985|OG001|Outcome|Basal Bolus Insulin With Glargine U100 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U100: Glargine U100 is a long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298159|NCT03013985|EG000|Reported Event|Basal Bolus Insulin With Glargine U300 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U300: Glargine U300 is a new generation long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298160|NCT03013985|EG001|Reported Event|Basal Bolus Insulin With Glargine U100 and Glulisine Insulin|"Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.~Glargine U100: Glargine U100 is a long-acting insulin.~Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal."
11298161|NCT03014011|BG000|Baseline|All Participants|Randomised, double-blinded, crossover study design
11298162|NCT03014011|FG000|Participant Flow|Hypoglycaemic Clamp Followed by Euglycaemic Clamp|Participants completed a hypoglycaemic clamp on a first intervention visit. After a washout period of at least 2 weeks (maximum of 6 weeks), a euglycaemic clamp was performed on the second intervention visit.
11298163|NCT03014011|FG001|Participant Flow|Euglycaemic Clamp Followed by Hypoglycaemic Clamp|Participants completed a euglycaemic clamp on a first intervention visit. After a washout periodof at least 2 weeks (maximum of 6 weeks), a hypoglycaemic clamp was performed on the second intervention visit.
11298164|NCT03014011|OG000|Outcome|Hypoglycaemia|low glucose level
11298165|NCT03014011|OG001|Outcome|Euglycaemia|normal glucose level
11298166|NCT03014011|EG000|Reported Event|Hypoglycaemic Clamp|Mean plasma glucose concentration during the neurocognitive testing was 3.13 mmol/l for the hypoglycaemic clamp.
11298167|NCT03014011|EG001|Reported Event|Euglycaemic Clamp|Mean plasma glucose concentration during the neurocognitive testing was 5.83 mmol/l for the euglycaemic clamp.
11298168|NCT03014180|BG000|Baseline|"In-Clinic LVAT"|Single-arm study design: all the 60 patients were assigned to the treatment arm.
11298169|NCT03014180|FG000|Participant Flow|"In-Clinic LVAT"|60 patients were included in the single-arm study. The Left Ventricular auto threshold (LVAT) algorithm test was performed at the 2 study visits M0 and M1.
11298170|NCT03014180|OG000|Outcome|In-clinic LVAT|Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
11298171|NCT03014180|OG000|Outcome|In-clinic LVAT|Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 visit.
11298172|NCT03014180|OG000|Outcome|In-clinic LVAT|Patients assigned to the single-arm treatment LVAT at M0 visit.
11298173|NCT03014180|OG000|Outcome|In-clinic LVAT|Patients assigned to the single-arm treatment LVAT at M1 visit.
10848351|NCT00289731|OG000|Outcome|Engerix-B+Havrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11298174|NCT03014180|OG000|Outcome|Secondary Endpoint|All serious adverse events and device deficiency during in-clinic LVAT test.
11298175|NCT03014180|EG000|Reported Event|In-Clinic LVAT|All serious adverse events and device deficiency during in-clinic LVAT test.
11298176|NCT03014206|BG000|Baseline|Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)|Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
11298177|NCT03014206|FG000|Participant Flow|Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)|Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
11298178|NCT03014206|OG000|Outcome|Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)|Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
11298179|NCT03014206|EG000|Reported Event|Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)|Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
11298180|NCT03014453|BG000|Baseline|Extremely Premature Infants With Bronchopulmonary Dysplasia|This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
11298181|NCT03014453|FG000|Participant Flow|Extremely Premature Infants With Bronchopulmonary Dysplasia|Single arm-extremely premature infants with bronchopulmonary dysplasia
11298182|NCT03014453|OG000|Outcome|Extremely Premature Infants With Bronchopulmonary Dysplasia|This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
11298183|NCT03014453|EG000|Reported Event|Extremely Premature Infants With Bronchopulmonary Dysplasia|This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
11298184|NCT03014479|BG000|Baseline|Trelagliptin|Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.
11298185|NCT03014479|BG001|Baseline|Daily DPP-4 Inhibitors|An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
11298186|NCT03014479|BG002|Baseline|Total|Total of all reporting groups
11217338|NCT02312739|FG000|Participant Flow|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11217339|NCT02312739|FG001|Participant Flow|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11217340|NCT02312739|OG000|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11217341|NCT02312739|OG001|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11217342|NCT02312739|EG000|Reported Event|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11217343|NCT02312739|EG001|Reported Event|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11217344|NCT02312765|BG000|Baseline|Intervention: AirCare System|"Study participants will receive a tablet computer with the AirCare system.~AirCare App: Tablet software to encourage adherence and support"
11217345|NCT02312765|BG001|Baseline|Control: Standard of Care|Standard care: This is the care that would be routinely provided by their healthcare provider
11217346|NCT02312765|BG002|Baseline|Total|Total of all reporting groups
11217347|NCT02312765|FG000|Participant Flow|Intervention: AirCare System|"Study participants will receive a tablet computer with the AirCare system.~AirCare App: Tablet software to encourage adherence and support"
10971411|NCT00915525|FG001|Participant Flow|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11217348|NCT02312765|FG001|Participant Flow|Control: Standard of Care|Standard care consisting of routine clinical care provided by their healthcare providers
11217349|NCT02312765|OG000|Outcome|Intervention: AirCare System|"Study participants will receive a tablet computer with the AirCare system.~AirCare App: Tablet software to encourage adherence and support"
11217350|NCT02312765|OG001|Outcome|Control: Standard Care|Standard care: This is the care that would be routinely provided by their healthcare provider
11217351|NCT02312765|EG000|Reported Event|Intervention: AirCare System|"Study participants will receive a tablet computer with the AirCare system.~AirCare App: Tablet software to encourage adherence and support"
11217352|NCT02312765|EG001|Reported Event|Control: Standard Care|Standard care: This is the care that would be routinely provided by their healthcare provider
11217353|NCT02312856|BG000|Baseline|PulseRider|Total Participants
11217354|NCT02312856|FG000|Participant Flow|PulseRider|Subjects 1 year Follow Up
11217355|NCT02312856|OG000|Outcome|Safety|Number of affected participants
11217356|NCT02312856|EG000|Reported Event|Number|Number of Participants between the procedure and 365 days
11217357|NCT02312882|BG000|Baseline|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
11217358|NCT02312882|FG000|Participant Flow|Tofacitinib|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
11217359|NCT02312882|OG000|Outcome|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
11298187|NCT03014479|FG000|Participant Flow|Trelagliptin|Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.
10971412|NCT00915525|OG000|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11217360|NCT02312882|EG000|Reported Event|Treatment Arm|Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
11217361|NCT02312934|BG000|Baseline|Transdermal Nicotine|"Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence."
11217362|NCT02312934|BG001|Baseline|Placebo|"Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Placebo Transdermal Patch"
11217363|NCT02312934|BG002|Baseline|Total|Total of all reporting groups
11217364|NCT02312934|FG000|Participant Flow|Transdermal Nicotine|"Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence."
11217365|NCT02312934|FG001|Participant Flow|Placebo|"Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Placebo Transdermal Patch"
11217366|NCT02312934|OG000|Outcome|Transdermal Nicotine|"Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence."
11217367|NCT02312934|OG001|Outcome|Placebo|"Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Placebo Transdermal Patch"
11217368|NCT02312934|OG001|Outcome|Placebo|"Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Placebo Transdermal Patch: Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm."
11217369|NCT02312934|EG000|Reported Event|Transdermal Nicotine|"Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence."
11217370|NCT02312934|EG001|Reported Event|Placebo|"Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.~Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal~Placebo Transdermal Patch"
11217371|NCT02312986|BG000|Baseline|Fecal Microbiota Transplantation|"Subjects will receive 150mL of fecal microbiota product via enema.~Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms."
11217372|NCT02312986|FG000|Participant Flow|Fecal Microbiota Transplantation|"Subjects will receive 150mL of fecal microbiota product via enema.~Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms."
11217373|NCT02312986|OG000|Outcome|Fecal Microbiota Transplantation|"Subjects will receive 150mL of fecal microbiota product via enema.~Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms."
11298188|NCT03014479|FG001|Participant Flow|Daily DPP-4 Inhibitors|An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
11298189|NCT03014479|OG000|Outcome|Trelagliptin|Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.
11298190|NCT03014479|OG001|Outcome|Daily DPP-4 Inhibitors|An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
11298191|NCT03014479|EG000|Reported Event|Trelagliptin|Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.
11298192|NCT03014479|EG001|Reported Event|Daily DPP-4 Inhibitors|An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
11298193|NCT03014492|BG000|Baseline|Collar Group|"Soccer girls that wore the collar device~Q Collar: Collar designed to mitigate slosh in the brain"
11298194|NCT03014492|BG001|Baseline|No Collar Group|soccer girls that did not wear the collar
11298195|NCT03014492|BG002|Baseline|Total|Total of all reporting groups
11298196|NCT03014492|FG000|Participant Flow|Collar Group|"Soccer girls that wore the collar device~Q Collar: Collar designed to mitigate slosh in the brain"
11298197|NCT03014492|FG001|Participant Flow|No Collar Group|soccer girls that did not wear the collar
11298198|NCT03014492|OG000|Outcome|Collar Group|"Soccer girls that wore the collar device~Q Collar: Collar designed to mitigate slosh in the brain"
11298199|NCT03014492|OG001|Outcome|No Collar Group|soccer girls that did not wear the collar
11298200|NCT03014492|EG000|Reported Event|Collar Group|"Soccer girls that wore the collar device~Q Collar: Collar designed to mitigate slosh in the brain"
11298201|NCT03014492|EG001|Reported Event|No Collar Group|soccer girls that did not wear the collar
11298202|NCT03014674|BG000|Baseline|Lyophilized Vial|Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298203|NCT03014674|BG001|Baseline|Liquid Autoinjector|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298204|NCT03014674|BG002|Baseline|Liquid Safety Syringe|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298205|NCT03014674|BG003|Baseline|Total|Total of all reporting groups
11298206|NCT03014674|FG000|Participant Flow|Lyophilized Vial|Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298207|NCT03014674|FG001|Participant Flow|Liquid Autoinjector|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298208|NCT03014674|FG002|Participant Flow|Liquid Safety Syringe|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298209|NCT03014674|OG000|Outcome|Lyophilized Vial|Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298210|NCT03014674|OG001|Outcome|Liquid Autoinjector|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298211|NCT03014674|OG002|Outcome|Liquid Safety Syringe|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298212|NCT03014674|EG000|Reported Event|Lyophilized Vial|Participants were administered 100 milligram per milliliter (mg/mL) subcutaneous (SC) dose of mepolizumab as lyophilized powder reconstituted with sterile water for injection from vial. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298213|NCT03014674|EG001|Reported Event|Liquid Autoinjector|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled autoinjector. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298214|NCT03014674|EG002|Reported Event|Liquid Safety Syringe|Participants were administered 100 mg/mL SC dose of mepolizumab liquid formulation via disposable pre-filled safety syringe. Participants were administered a single SC dose in upper arm, abdomen or thigh.
11298215|NCT03014700|BG000|Baseline|Cryoprecipitate Arm|"Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group~Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group"
11298216|NCT03014700|BG001|Baseline|Fibrinogen Concentrate Arm|"Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group~Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group"
11298217|NCT03014700|BG002|Baseline|Total|Total of all reporting groups
11298218|NCT03014700|FG000|Participant Flow|Cryoprecipitate Arm|"Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group~Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group"
11298219|NCT03014700|FG001|Participant Flow|Fibrinogen Concentrate Arm|"Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group~Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group"
11298220|NCT03014700|OG000|Outcome|Cryoprecipitate Arm|"Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group~Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group"
11298221|NCT03014700|OG001|Outcome|Fibrinogen Concentrate Arm|"Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group~Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group"
11298222|NCT03014700|EG000|Reported Event|Cryoprecipitate Arm|"Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group~Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group"
11298223|NCT03014700|EG001|Reported Event|Fibrinogen Concentrate Arm|"Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group~Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group"
11298224|NCT03015116|BG000|Baseline|Usual Care|"Participants will complete 6 weeks of stretching and cryotherapy~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching"
11298225|NCT03015116|BG001|Baseline|PBM 10 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output"
11298226|NCT03015116|BG002|Baseline|PBM 25 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation High Power: Photobiomodulation treatment with 25W power output"
11298227|NCT03015116|BG003|Baseline|Total|Total of all reporting groups
11298228|NCT03015116|FG000|Participant Flow|Usual Care|"Participants will complete 6 weeks of stretching and cryotherapy~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching"
11298229|NCT03015116|FG001|Participant Flow|PBM 10 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output"
11298230|NCT03015116|FG002|Participant Flow|PBM 25 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation High Power: Photobiomodulation treatment with 25W power output"
11298231|NCT03015116|OG000|Outcome|Usual Care|"Participants will complete 6 weeks of stretching and cryotherapy~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching"
11298232|NCT03015116|OG001|Outcome|PBM 10 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output"
11298233|NCT03015116|OG002|Outcome|PBM 25 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation High Power: Photobiomodulation treatment with 25W power output"
11298234|NCT03015116|OG000|Outcome|PBM 10 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output"
11298235|NCT03015116|OG001|Outcome|PBM 25 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation High Power: Photobiomodulation treatment with 25W power output"
10971413|NCT00915525|OG001|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971414|NCT00915525|EG000|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 1|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11298236|NCT03015116|EG000|Reported Event|Usual Care|"Participants will complete 6 weeks of stretching and cryotherapy~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching"
11298237|NCT03015116|EG001|Reported Event|PBM 10 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output"
11298238|NCT03015116|EG002|Reported Event|PBM 25 Watts|"Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks~Stretching: Daily foot and ankle stretching protocol~Cryotherapy: Daily cryotherapy in conjunction with stretching~Photobiomodulation High Power: Photobiomodulation treatment with 25W power output"
11298239|NCT03015181|BG000|Baseline|Group 1: 1 mg/kg IV Single Dose|"Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298240|NCT03015181|BG001|Baseline|Group 2: 5 mg/kg IV Single Dose|"Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298241|NCT03015181|BG002|Baseline|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298242|NCT03015181|BG003|Baseline|Group 4: 20 mg/kg IV Single Dose|"Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298243|NCT03015181|BG004|Baseline|Group 5: 40 mg/kg IV Single Dose|"Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298244|NCT03015181|BG005|Baseline|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298245|NCT03015181|BG006|Baseline|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298246|NCT03015181|BG007|Baseline|Total|Total of all reporting groups
11298247|NCT03015181|FG000|Participant Flow|Group 1: 1 mg/kg IV Single Dose|"Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298248|NCT03015181|FG001|Participant Flow|Group 2: 5 mg/kg IV Single Dose|"Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298249|NCT03015181|FG002|Participant Flow|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298250|NCT03015181|FG003|Participant Flow|Group 4: 20 mg/kg IV Single Dose|"Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298251|NCT03015181|FG004|Participant Flow|Group 5: 40 mg/kg IV Single Dose|"Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298252|NCT03015181|FG005|Participant Flow|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298253|NCT03015181|FG006|Participant Flow|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298254|NCT03015181|OG000|Outcome|Group 1: 1 mg/kg IV Single Dose|"Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298255|NCT03015181|OG001|Outcome|Group 2: 5 mg/kg IV Single Dose|"Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298256|NCT03015181|OG002|Outcome|Group 4: 20 mg/kg IV Single Dose|"Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298257|NCT03015181|OG003|Outcome|Group 5: 40 mg/kg IV Single Dose|"Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298258|NCT03015181|OG004|Outcome|Group 7: 20 mg/kg IV Multiple Doses: Dose 1|"Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298259|NCT03015181|OG005|Outcome|Group 7: 20 mg/kg IV Multiple Doses: Dose 2|"Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298260|NCT03015181|OG006|Outcome|Group 7: 20 mg/kg IV Multiple Doses: Dose 3|"Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298261|NCT03015181|OG007|Outcome|Overall IV Groups|Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups
11298262|NCT03015181|OG008|Outcome|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298263|NCT03015181|OG009|Outcome|Group 6: 5 mg/kg SC Multiple Doses: Dose 1|"Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298264|NCT03015181|OG010|Outcome|Group 6: 5 mg/kg SC Multiple Doses: Dose 2|"Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298265|NCT03015181|OG011|Outcome|Group 6: 5 mg/kg SC Multiple Doses: Dose 3|"Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298266|NCT03015181|OG012|Outcome|Overall SC Groups|Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
11298267|NCT03015181|OG009|Outcome|Group 6: 5 mg/kg SC Multiple Doses: Dose 1|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298268|NCT03015181|OG002|Outcome|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298269|NCT03015181|OG003|Outcome|Group 4: 20 mg/kg IV Single Dose|"Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298270|NCT03015181|OG004|Outcome|Group 5: 40 mg/kg IV Single Dose|"Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298271|NCT03015181|OG005|Outcome|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10971415|NCT00915525|EG001|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 2|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971416|NCT00915525|EG002|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 2|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11217374|NCT02312986|EG000|Reported Event|Fecal Microbiota Transplantation|"Subjects will receive 150mL of fecal microbiota product via enema.~Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms."
11217375|NCT02313155|BG000|Baseline|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11217376|NCT02313155|BG001|Baseline|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11217377|NCT02313155|BG002|Baseline|Total|Total of all reporting groups
11217378|NCT02313155|FG000|Participant Flow|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11217379|NCT02313155|FG001|Participant Flow|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11217380|NCT02313155|OG000|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11217381|NCT02313155|OG001|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11217382|NCT02313155|EG000|Reported Event|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11217383|NCT02313155|EG001|Reported Event|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11217384|NCT02313233|BG000|Baseline|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11217385|NCT02313233|BG001|Baseline|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11217386|NCT02313233|BG002|Baseline|Total|Total of all reporting groups
11217387|NCT02313233|FG000|Participant Flow|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11217388|NCT02313233|FG001|Participant Flow|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11217389|NCT02313233|OG000|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11217390|NCT02313233|OG001|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11217391|NCT02313233|OG000|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11298272|NCT03015181|OG006|Outcome|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298273|NCT03015181|OG007|Outcome|Overall|Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB)
11298274|NCT03015181|OG000|Outcome|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298275|NCT03015181|OG001|Outcome|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298276|NCT03015181|OG004|Outcome|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298277|NCT03015181|OG005|Outcome|Overall IV Groups|Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups
11298278|NCT03015181|OG006|Outcome|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298279|NCT03015181|OG007|Outcome|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298280|NCT03015181|OG008|Outcome|Overall SC Groups|Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
11298281|NCT03015181|EG000|Reported Event|Group 1: 1 mg/kg IV Single Dose|"Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298282|NCT03015181|EG001|Reported Event|Group 2: 5 mg/kg IV Single Dose|"Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298283|NCT03015181|EG002|Reported Event|Group 4: 20 mg/kg IV Single Dose|"Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298284|NCT03015181|EG003|Reported Event|Group 5: 40 mg/kg IV Single Dose|"Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298285|NCT03015181|EG004|Reported Event|Group 7: 20 mg/kg IV Multiple Doses|"Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298286|NCT03015181|EG005|Reported Event|Group 3: 5 mg/kg SC Single Dose|"Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
10971417|NCT00915525|EG003|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 3|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11298287|NCT03015181|EG006|Reported Event|Group 6: 5 mg/kg SC Multiple Doses|"Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.~VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1."
11298288|NCT03015220|BG000|Baseline|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298289|NCT03015220|BG001|Baseline|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298290|NCT03015220|BG002|Baseline|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298291|NCT03015220|BG003|Baseline|Dulaglutide 0.75 mg|Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298292|NCT03015220|BG004|Baseline|Total|Total of all reporting groups
11298293|NCT03015220|FG000|Participant Flow|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298294|NCT03015220|FG001|Participant Flow|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11217392|NCT02313233|OG000|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water."
11217393|NCT02313233|EG000|Reported Event|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11217394|NCT02313233|EG001|Reported Event|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11217395|NCT02313454|BG000|Baseline|All Participants|Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217396|NCT02313454|FG000|Participant Flow|Intranasal Then Extranasal Application|Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, extranasal application (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11298295|NCT03015220|FG002|Participant Flow|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
10971418|NCT00915525|EG004|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 3|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11217397|NCT02313454|FG001|Participant Flow|Extranasal Then Intranasal Application|Intranasal Tear Neurostimulator device, extranasal application (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217398|NCT02313454|OG000|Outcome|Intranasal Application|Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217399|NCT02313454|OG001|Outcome|Extranasal Application|Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217400|NCT02313454|EG000|Reported Event|Intranasal Application|Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217401|NCT02313454|EG001|Reported Event|Extranasal Application|Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
11217402|NCT02313506|BG000|Baseline|Immediate Intervention Group|"Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.~Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately."
11217403|NCT02313506|BG001|Baseline|Delayed Intervention Group|"Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.~Same intervention with a 1 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay."
11217404|NCT02313506|BG002|Baseline|Total|Total of all reporting groups
11217405|NCT02313506|FG000|Participant Flow|Immediate Intervention Group|"Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.~Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately."
11217406|NCT02313506|FG001|Participant Flow|Delayed Intervention Group|"Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.~Same intervention with a 1 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay."
11217407|NCT02313506|OG000|Outcome|Immediate Intervention Group|"Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.~Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately."
11217408|NCT02313506|OG001|Outcome|Delayed Intervention Group|Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
11217409|NCT02313506|OG000|Outcome|Immediate Intervention Group|Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
11217410|NCT02313506|EG000|Reported Event|Immediate Intervention Group|Education session, Fitbit Flex, and remote coaching by a PT. These three components of the intervention will be delivered to the participants in Month 1. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
11217411|NCT02313506|EG001|Reported Event|Delayed Intervention Group|Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.
11217412|NCT02313558|BG000|Baseline|Dentifrice Containing Ilex Rotunda Thunb|"use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks~Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks"
11217413|NCT02313558|BG001|Baseline|Control Dentifrice|"use the control dentifrice to brush teeth twice daily for 12 weeks~Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks"
11217414|NCT02313558|BG002|Baseline|Total|Total of all reporting groups
11217415|NCT02313558|FG000|Participant Flow|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11217416|NCT02313558|FG001|Participant Flow|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
10848352|NCT00289731|OG001|Outcome|HB VAX PRO+Vaqta Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
11217417|NCT02313558|OG000|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11217418|NCT02313558|OG001|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11217419|NCT02313558|EG000|Reported Event|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11217420|NCT02313558|EG001|Reported Event|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11217421|NCT02313597|BG000|Baseline|SETON|Hydrogen peroxide was injected to the external opening with a 10-cc syringe, and the internal opening was located by direct visualization of the anal canal via proctoscope. A cannulating probe was inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture was then tied to the tip of the probe, which was then squeezed out of the external opening. The suture was then tied around the sphincter and through fistula tract, Later, the seton was tightened at four week interval under spinal anesthesia until the suture cut through the sphincter.
11217422|NCT02313597|BG001|Baseline|VAAFT|The external opening was widened with a probe, and a fistulascope was inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening was then stitched with Vicryl™(Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. And the tract of the fistula was washed and debrided through scope and it was coagulated with cautry so that tract be closed.
11217423|NCT02313597|BG002|Baseline|Total|Total of all reporting groups
11217424|NCT02313597|FG000|Participant Flow|SETON|Hydrogen peroxide was injected to the external opening with a 10-cc syringe, and the internal opening was located by direct visualization of the anal canal via proctoscope. A cannulating probe was inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture was then tied to the tip of the probe, which was then squeezed out of the external opening. The suture was then tied around the sphincter and through fistula tract, Later, the seton was tightened at four week interval under spinal anesthesia until the suture cut through the sphincter.
11217425|NCT02313597|FG001|Participant Flow|VAAFT|The external opening was widened with a probe, and a fistulascope was inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening was then stitched with Vicryl™(Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. And the tract of the fistula was washed and debrided through scope and it was coagulated with cautry so that tract be closed.
11217426|NCT02313597|OG000|Outcome|SETON|Hydrogen peroxide was injected to the external opening with a 10-cc syringe, and the internal opening was located by direct visualization of the anal canal via proctoscope. A cannulating probe was inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture was then tied to the tip of the probe, which was then squeezed out of the external opening. The suture was then tied around the sphincter and through fistula tract, Later, the seton was tightened at four week interval under spinal anesthesia until the suture cut through the sphincter.
11217427|NCT02313597|OG001|Outcome|VAAFT|The external opening was widened with a probe, and a fistulascope was inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening was then stitched with Vicryl™(Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. And the tract of the fistula was washed and debrided through scope and it was coagulated with cautry so that tract be closed.
11217428|NCT02313597|EG000|Reported Event|SETON|Hydrogen peroxide was injected to the external opening with a 10-cc syringe, and the internal opening was located by direct visualization of the anal canal via proctoscope. A cannulating probe was inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture was then tied to the tip of the probe, which was then squeezed out of the external opening. The suture was then tied around the sphincter and through fistula tract, Later, the seton was tightened at four week interval under spinal anesthesia until the suture cut through the sphincter.
11217429|NCT02313597|EG001|Reported Event|VAAFT|The external opening was widened with a probe, and a fistulascope was inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening was then stitched with Vicryl™(Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. And the tract of the fistula was washed and debrided through scope and it was coagulated with cautry so that tract be closed.
11217430|NCT02313675|BG000|Baseline|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
11217431|NCT02313675|BG001|Baseline|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
11217432|NCT02313675|BG002|Baseline|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
11217433|NCT02313675|BG003|Baseline|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
11217434|NCT02313675|BG004|Baseline|Total|Total of all reporting groups
11217435|NCT02313675|FG000|Participant Flow|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
11217436|NCT02313675|FG001|Participant Flow|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
11217437|NCT02313675|FG002|Participant Flow|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
11217438|NCT02313675|FG003|Participant Flow|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
11217439|NCT02313675|OG000|Outcome|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
11217440|NCT02313675|OG001|Outcome|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
11217441|NCT02313675|OG002|Outcome|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
11217442|NCT02313675|OG003|Outcome|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
11217443|NCT02313675|EG000|Reported Event|IV Tylenol|"One time intra-operative IV acetaminophen administration~Acetaminophen"
11217444|NCT02313675|EG001|Reported Event|IV Toradol|"One time intra-operative IV ketorolac thromethamine administration~Ketorolac Tromethamine"
11217445|NCT02313675|EG002|Reported Event|IV Tylenol/Toradol Combination|"One time intra-operative IV combination of acetaminophen/ketorolac administration~Acetaminophen~Ketorolac Tromethamine"
11217446|NCT02313675|EG003|Reported Event|Saline|"One time intra-operative 50ml IV normal saline administration~Saline"
10848353|NCT00289731|EG000|Reported Event|Twinrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
10971419|NCT00915525|EG005|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 4|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11217447|NCT02313766|BG000|Baseline|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11217448|NCT02313766|BG001|Baseline|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11217449|NCT02313766|BG002|Baseline|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11217450|NCT02313766|BG003|Baseline|Total|Total of all reporting groups
11217451|NCT02313766|FG000|Participant Flow|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11217452|NCT02313766|FG001|Participant Flow|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
10848354|NCT00289731|EG001|Reported Event|Engerix-B+Havrix Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
10848355|NCT00289731|EG002|Reported Event|HB VAX PRO+Vaqta Group|Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
10848356|NCT00289744|BG000|Baseline|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
10848357|NCT00289744|FG000|Participant Flow|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
10848358|NCT00289744|FG001|Participant Flow|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
10848359|NCT00289744|FG002|Participant Flow|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
10848360|NCT00289744|OG000|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
10848361|NCT00289744|OG000|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
10848362|NCT00289744|OG001|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
11217453|NCT02313766|FG002|Participant Flow|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11217454|NCT02313766|OG000|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11217455|NCT02313766|OG001|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11217456|NCT02313766|OG002|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
10848363|NCT00289744|EG000|Reported Event|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
11217457|NCT02313766|EG000|Reported Event|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11217458|NCT02313766|EG001|Reported Event|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11217459|NCT02313766|EG002|Reported Event|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11217460|NCT02313909|BG000|Baseline|Rivaroxaban 15 mg OD|Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
11217461|NCT02313909|BG001|Baseline|Acetylsalicylic Acid 100 mg OD|Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
11217462|NCT02313909|BG002|Baseline|Total|Total of all reporting groups
11217463|NCT02313909|FG000|Participant Flow|Rivaroxaban 15 mg OD|Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
11217464|NCT02313909|FG001|Participant Flow|Acetylsalicylic Acid 100 mg OD|Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
10848364|NCT00289744|EG001|Reported Event|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
11217465|NCT02313909|OG000|Outcome|Rivaroxaban 15 mg OD|Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
11217466|NCT02313909|OG001|Outcome|Acetylsalicylic Acid 100 mg OD|Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
11217467|NCT02313909|EG000|Reported Event|Rivaroxaban 15 mg OD|Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
11217468|NCT02313909|EG001|Reported Event|Acetylsalicylic Acid 100 mg OD|Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
11217469|NCT02314000|BG000|Baseline|SCS Starting at Supra-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System programmed starting at supra-perception and followed by sub-perception amplitude.~Precision or Precision Spectra Spinal Cord Stimulator System"
11217470|NCT02314000|BG001|Baseline|SCS Starting at Sub-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System starting at sub-perception and followed by supra-perception amplitude.~Precision or Precision Spectra Spinal Cord Stimulator System"
11217471|NCT02314000|BG002|Baseline|Total|Total of all reporting groups
11217472|NCT02314000|FG000|Participant Flow|SCS Starting With Supra-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with supra-perception followed by sub-perception amplitude.~Precision or Precision Spectra Spinal Cord Stimulator System"
11217473|NCT02314000|FG001|Participant Flow|SCS Starting With Sub-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with sub-perception and followed by supra-perception amplitude.~Precision or Precision Spectra Spinal Cord Stimulator System"
11217474|NCT02314000|OG000|Outcome|SCS With Supra-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception amplitude~Precision or Precision Spectra Spinal Cord Stimulator System"
11217475|NCT02314000|OG001|Outcome|SCS With Sub-perception Amplitude|"Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception amplitude~Precision or Precision Spectra Spinal Cord Stimulator System"
11217476|NCT02314000|EG000|Reported Event|All Study Patients Through End of Randomized Phase|All adverse events reported through end of randomized phase
11217477|NCT02314000|EG001|Reported Event|SCS With Supra Perception Amplitude|All adverse events during SCS with supra perception amplitude
11217478|NCT02314000|EG002|Reported Event|SCS With Subperception Amplitude|All adverse events during SCS with supra perception amplitude
11217479|NCT02314026|BG000|Baseline|Suspected NASH|"13C-Octanoate, 13C-Methacetin~Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water~Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water"
11217480|NCT02314026|FG000|Participant Flow|Suspected NASH|"13C-Octanoate, 13C-Methacetin~Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water~Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water"
11217481|NCT02314026|OG000|Outcome|Suspected NASH|"13C-Octanoate, 13C-Methacetin~Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water~Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water"
11217482|NCT02314026|EG000|Reported Event|Suspected NASH|"13C-Octanoate, 13C-Methacetin~Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water~Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water"
11298296|NCT03015220|FG003|Participant Flow|Dulaglutide 0.75 mg|Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298297|NCT03015220|OG000|Outcome|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298298|NCT03015220|OG001|Outcome|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298299|NCT03015220|OG002|Outcome|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298300|NCT03015220|OG003|Outcome|Dulaglutide 0.75 mg|Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298301|NCT03015220|EG000|Reported Event|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298302|NCT03015220|EG001|Reported Event|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298303|NCT03015220|EG002|Reported Event|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298304|NCT03015220|EG003|Reported Event|Dulaglutide 0.75 mg|Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.
11298305|NCT03015363|BG000|Baseline|Prospective Cohort (1)|Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
11298306|NCT03015363|FG000|Participant Flow|Prospective Cohort (1)|Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
11298307|NCT03015363|OG000|Outcome|Prospective Cohort (1)|Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
11298308|NCT03015363|EG000|Reported Event|Prospective Cohort (1)|Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
11298309|NCT03015532|BG000|Baseline|Cohort 1, Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
11298310|NCT03015532|BG001|Baseline|Cohort 1, Group 2: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
11298311|NCT03015532|BG002|Baseline|Cohort 1, Group 3: Saline Placebo|Saline placebo via injection.
11298312|NCT03015532|BG003|Baseline|Cohort 1, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298313|NCT03015532|BG004|Baseline|Cohort 2, Group 1: HTX-011|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
11298314|NCT03015532|BG005|Baseline|Cohort 2, Group 2: HTX-011 + Ropivacaine|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
11298315|NCT03015532|BG006|Baseline|Cohort 2, Group 3: Saline Placebo|Saline placebo via injection.
11298316|NCT03015532|BG007|Baseline|Cohort 2, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298317|NCT03015532|BG008|Baseline|Total|Total of all reporting groups
11298318|NCT03015532|FG000|Participant Flow|Cohort 1, Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
11298319|NCT03015532|FG001|Participant Flow|Cohort 1, Group 2: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
11298320|NCT03015532|FG002|Participant Flow|Cohort 1, Group 3: Saline Placebo|Saline placebo via injection.
11298321|NCT03015532|FG003|Participant Flow|Cohort 1, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298322|NCT03015532|FG004|Participant Flow|Cohort 2, Group 1: HTX-011|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
11298323|NCT03015532|FG005|Participant Flow|Cohort 2, Group 2: HTX-011 + Ropivacaine|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
11298324|NCT03015532|FG006|Participant Flow|Cohort 2, Group 3: Saline Placebo|Saline placebo via injection.
11298325|NCT03015532|FG007|Participant Flow|Cohort 2, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298326|NCT03015532|OG000|Outcome|Cohort 1, Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
11298327|NCT03015532|OG001|Outcome|Cohort 1, Group 2: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
11298328|NCT03015532|OG002|Outcome|Cohort 1, Group 3: Saline Placebo|Saline placebo via injection.
11298329|NCT03015532|OG003|Outcome|Cohort 1, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298330|NCT03015532|OG004|Outcome|Cohort 2, Group 1: HTX-011|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
11298331|NCT03015532|OG005|Outcome|Cohort 2, Group 2: HTX-011 + Ropivacaine|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
11298332|NCT03015532|OG006|Outcome|Cohort 2, Group 3: Saline Placebo|Saline placebo via injection.
11298333|NCT03015532|OG007|Outcome|Cohort 2, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
10971420|NCT00915525|EG006|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 4|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971421|NCT00915525|EG007|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 5|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971422|NCT00915525|EG008|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 5|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971423|NCT00915525|EG009|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 6|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
11298334|NCT03015532|OG004|Outcome|Cohort 2, Group 1: HTX-011|HTX-011, 400 mg/12 mg via instillation.
11298335|NCT03015532|OG005|Outcome|Cohort 2, Group 2: HTX-011 + Ropivacaine|HTX-011, 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
11298336|NCT03015532|EG000|Reported Event|Cohort 1, Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
11298337|NCT03015532|EG001|Reported Event|Cohort 1, Group 2: HTX-011|HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination).
11298338|NCT03015532|EG002|Reported Event|Cohort 1, Group 3: Saline Placebo|Saline placebo via injection.
11298339|NCT03015532|EG003|Reported Event|Cohort 1, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298340|NCT03015532|EG004|Reported Event|Cohort 2, Group 1: HTX-011|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
11298341|NCT03015532|EG005|Reported Event|Cohort 2, Group 2: HTX-011 + Ropivacaine|HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
11298342|NCT03015532|EG006|Reported Event|Cohort 2, Group 3: Saline Placebo|Saline placebo via injection.
11298343|NCT03015532|EG007|Reported Event|Cohort 2, Group 4: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 125 mg via injection.
11298344|NCT03015649|BG000|Baseline|SCOUT Device|All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
11298345|NCT03015649|FG000|Participant Flow|SCOUT Device|All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
11298346|NCT03015649|OG000|Outcome|SCOUT Device|All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
11298347|NCT03015649|EG000|Reported Event|SCOUT Device|All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
11298348|NCT03015961|BG000|Baseline|EXPAREL Admixed With Bupivacaine HCl|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline
11298349|NCT03015961|BG001|Baseline|Bupivacaine HCl|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
11298350|NCT03015961|BG002|Baseline|Total|Total of all reporting groups
11298351|NCT03015961|FG000|Participant Flow|EXPAREL Admixed With Bupivacaine HCl|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline
11298352|NCT03015961|FG001|Participant Flow|Bupivacaine HCl|Local infiltration analgesia with bupivacaine hydrochloride (HCl) 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
11298353|NCT03015961|OG000|Outcome|EXPAREL Admixed With Bupivacaine HCl|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline
11298354|NCT03015961|OG001|Outcome|Bupivacaine HCl|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
11298355|NCT03015961|EG000|Reported Event|EXPAREL Admixed With Bupivacaine HCl|Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline
11298356|NCT03015961|EG001|Reported Event|Bupivacaine HCl|Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
11298357|NCT03016078|BG000|Baseline|Mepilex Border Post-Op Ag Dressing|A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
11298358|NCT03016078|FG000|Participant Flow|Mepilex Border Post-Op Ag Dressing|A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
11298359|NCT03016078|OG000|Outcome|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
11298360|NCT03016078|EG000|Reported Event|The Study Group|Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
11298361|NCT03016325|BG000|Baseline|Placebo - Part I|Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298362|NCT03016325|BG001|Baseline|BMS-986231 - Part I|Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298363|NCT03016325|BG002|Baseline|Placebo - Part II|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
11298364|NCT03016325|BG003|Baseline|BMS-986231 6 µg/kg/Min - Part II|BMS-986231 dose of 6 µg/kg/min for 48 hours
11298365|NCT03016325|BG004|Baseline|BMS-986231 12 µg/kg/Min - Part II|BMS-986231 dose of 12 µg/kg/min for 48 hours
11298366|NCT03016325|BG005|Baseline|Placebo - Part II (Japan Cohort)|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
11298367|NCT03016325|BG006|Baseline|BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
11298368|NCT03016325|BG007|Baseline|BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
11298369|NCT03016325|BG008|Baseline|Total|Total of all reporting groups
11298370|NCT03016325|FG000|Participant Flow|Placebo - Part I|Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298371|NCT03016325|FG001|Participant Flow|BMS-986231 - Part I|Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298372|NCT03016325|FG002|Participant Flow|Placebo - Part II|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
11298373|NCT03016325|FG003|Participant Flow|BMS-986231 6 µg/kg/Min - Part II|BMS-986231 dose of 6 µg/kg/min for 48 hours
11298374|NCT03016325|FG004|Participant Flow|BMS-986231 12 µg/kg/Min - Part II|BMS-986231 dose of 12 µg/kg/min for 48 hours
11298375|NCT03016325|FG005|Participant Flow|Placebo - Part II (Japan Cohort)|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
11298376|NCT03016325|FG006|Participant Flow|BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
11298377|NCT03016325|FG007|Participant Flow|BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
11298378|NCT03016325|OG000|Outcome|Placebo - Part I|Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298379|NCT03016325|OG001|Outcome|BMS-986231 - Part I|Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298380|NCT03016325|OG002|Outcome|Placebo - Part II|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
11298381|NCT03016325|OG003|Outcome|BMS-986231 6 µg/kg/Min - Part II|BMS-986231 dose of 6 µg/kg/min for 48 hours
11298382|NCT03016325|OG004|Outcome|BMS-986231 12 µg/kg/Min - Part II|BMS-986231 dose of 12 µg/kg/min for 48 hours
11298383|NCT03016325|OG005|Outcome|Placebo - Part II (Japan Cohort)|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
11298384|NCT03016325|OG006|Outcome|BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
11298385|NCT03016325|OG007|Outcome|BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
11298386|NCT03016325|OG000|Outcome|Placebo - Part II (Japan Cohort)|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
11298387|NCT03016325|OG001|Outcome|BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
11298388|NCT03016325|OG002|Outcome|BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
11298389|NCT03016325|EG000|Reported Event|Placebo - Part I|Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298390|NCT03016325|EG001|Reported Event|BMS-986231 - Part I|Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)
11298391|NCT03016325|EG002|Reported Event|Placebo - Part II|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours
11298392|NCT03016325|EG003|Reported Event|BMS-986231 6 µg/kg/Min - Part II|BMS-986231 dose of 6 µg/kg/min for 48 hours
11298393|NCT03016325|EG004|Reported Event|BMS-986231 12 µg/kg/Min - Part II|BMS-986231 dose of 12 µg/kg/min for 48 hours
11298394|NCT03016325|EG005|Reported Event|Placebo - Part II (Japan Cohort)|Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants
11298395|NCT03016325|EG006|Reported Event|BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants
11298396|NCT03016325|EG007|Reported Event|BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)|BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants
11298397|NCT03016403|BG000|Baseline|Patients in Enhanced Usual Care|Patients who were randomized to Enhanced Usual Care
10971424|NCT00915525|EG010|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 6|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971425|NCT00915525|EG011|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 7|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971426|NCT00915525|EG012|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 7|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971427|NCT00915525|EG013|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 8|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971428|NCT00915525|EG014|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 8|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971429|NCT00915525|EG015|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 9|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971430|NCT00915525|EG016|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 9|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971431|NCT00915525|EG017|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 10|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971432|NCT00915525|EG018|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 10|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971433|NCT00915525|EG019|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 11|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971434|NCT00915525|EG020|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 12|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971435|NCT00915525|EG021|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 13|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
10971436|NCT00915538|BG000|Baseline|Conventional First|This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber
10971437|NCT00915538|BG001|Baseline|Spacer First|This arm will receive pMDI and Valved holding chamber on fist day. On anther day will receive pMDI in usual fashion. Pulmonary functions wil be measured over 12 hours
10971438|NCT00915538|BG002|Baseline|Total|Total of all reporting groups
10971439|NCT00915538|FG000|Participant Flow|Conventional First|This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber
10971440|NCT00915538|FG001|Participant Flow|Spacer First|This arm will receive pMDI and Valved holding chamber on fist day. On anther day will receive pMDI in usual fashion. Pulmonary functions wil be measured over 12 hours
10971441|NCT00915538|OG000|Outcome|Group 1|"The intervention in this group will inhalation from the pMDI containing budesonide/formoterol pMDI 160/4,5 2 inhalations as recommended in product PI (FDA approved product information)without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.~pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.~Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours."
10971442|NCT00915538|OG001|Outcome|Group 2|"The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device (aerochamber plus)which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..~pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.~Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours."
10971443|NCT00915538|OG000|Outcome|Spacer|This arm will receive pMDI Symbicort 160/4.5 with an Aerochamber Plus Valved holding chamber.
10971444|NCT00915538|OG001|Outcome|Non-Spacer (Conventional)|This arm will receive pMDI Symbicort 160/4.5 without an Aerochamber.
10971445|NCT00915538|EG000|Reported Event|Conventional|This group will use pMDI in usual fashion
10971446|NCT00915538|EG001|Reported Event|Spacer|This arm will receive pMDI and Valved holding chamber
10971447|NCT00915551|BG000|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971448|NCT00915551|BG001|Baseline|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
10971449|NCT00915551|BG002|Baseline|Total|Total of all reporting groups
10971450|NCT00915551|FG000|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971451|NCT00915551|FG001|Participant Flow|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
10971452|NCT00915551|OG000|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
10971453|NCT00915551|OG001|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
10971454|NCT00915551|EG000|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971455|NCT00915551|EG001|Reported Event|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
10971456|NCT00915590|BG000|Baseline|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
11298398|NCT03016403|BG001|Baseline|Patients in Stepped Care Intervention|Patients who were randomized to the Stepped Care Intervention
11298399|NCT03016403|BG002|Baseline|Caregivers in Enhanced Usual Care|Caregivers who were randomized to Enhanced Usual Care
11298400|NCT03016403|BG003|Baseline|Caregivers in Stepped Care Intervention|Caregivers who were randomized to the Stepped Care Intervention
11298401|NCT03016403|BG004|Baseline|Total|Total of all reporting groups
11298402|NCT03016403|FG000|Participant Flow|Patients in Enhanced Usual Care|Patients who were randomized to Enhanced Usual Care
11298403|NCT03016403|FG001|Participant Flow|Patients in Stepped Care Intervention|Patients who were randomized to the Stepped Care Intervention
11298404|NCT03016403|FG002|Participant Flow|Caregivers in Enhanced Usual Care|Caregivers who were randomized into Enhanced Usual Care
11298405|NCT03016403|FG003|Participant Flow|Caregivers in Stepped Care Intervention|Caregivers who were randomized to the Stepped Care Intervention
11298406|NCT03016403|OG000|Outcome|Patients in Enhanced Usual Care|Patients who were randomized to Enhanced Usual Care
11298407|NCT03016403|OG001|Outcome|Patients in Stepped Care Intervention|Patients who were randomized to the Stepped Care Intervention
11298408|NCT03016403|OG000|Outcome|Enhanced Usual Care|Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
11298409|NCT03016403|OG001|Outcome|Stepped-Care Intervention|"Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.~Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions."
11298410|NCT03016403|OG000|Outcome|Caregivers in Enhanced Usual Care|Caregivers who were randomized to Enhanced Usual Care
11298411|NCT03016403|OG001|Outcome|Caregivers in Stepped Care Intervention|Caregivers who were randomized to the Stepped Care Intervention
10971457|NCT00915590|BG001|Baseline|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971458|NCT00915590|BG002|Baseline|Total|Total of all reporting groups
11298412|NCT03016403|EG000|Reported Event|Patients in Enhanced Usual Care|Patients who were randomized to Enhanced Usual Care
11298413|NCT03016403|EG001|Reported Event|Patients in Stepped Care Intervention|Patients who were randomized to the Stepped Care Intervention
11298414|NCT03016403|EG002|Reported Event|Caregivers in Enhanced Usual Care|Caregivers who were randomized to Enhanced Usual Care
11298415|NCT03016403|EG003|Reported Event|Caregivers in Stepped Care Intervention|Caregivers who were randomized to the Stepped Care Intervention
11298416|NCT03016598|BG000|Baseline|Oxytocin|Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298417|NCT03016598|BG001|Baseline|Placebo|Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298418|NCT03016598|BG002|Baseline|Total|Total of all reporting groups
11298419|NCT03016598|FG000|Participant Flow|Oxytocin|"Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.~Intranasal oxytocin: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded."
11298420|NCT03016598|FG001|Participant Flow|Placebo|"Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.~Intranasal placebo: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded."
11298421|NCT03016598|OG000|Outcome|Oxytocin|Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298422|NCT03016598|OG001|Outcome|Placebo|Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298423|NCT03016598|EG000|Reported Event|Oxytocin|Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298424|NCT03016598|EG001|Reported Event|Placebo|Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
11298425|NCT03017079|BG000|Baseline|Semi-solidification With Nutrient|"semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.~Intervention: Other: bolus Intermittent enteral feeding~semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins"
11298426|NCT03017079|BG001|Baseline|Standard Enteral Nutrition|"After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.~Intervention: Other: Standard enteral feeding~standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins"
11298427|NCT03017079|BG002|Baseline|Total|Total of all reporting groups
11298428|NCT03017079|FG000|Participant Flow|Semi-solidification With Nutrient|"semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.~Intervention: Other: bolus Intermittent enteral feeding~semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins"
11298429|NCT03017079|FG001|Participant Flow|Standard Enteral Nutrition|"After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.~Intervention: Other: Standard enteral feeding~standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins"
11298430|NCT03017079|OG000|Outcome|Intermittent Feeding With Semi-solid Nutrients|semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.
11298431|NCT03017079|OG001|Outcome|Standard Enteral Feeding|"After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.~Intervention: Other: Standard enteral feeding~standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins"
11298432|NCT03017079|OG000|Outcome|Intermittent Feeding|"After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.~Intervention: Other: Standard enteral feeding~standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins"
11298433|NCT03017079|OG001|Outcome|Intermittent Feeding With Semi-solid Nutrients|"semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.~Intervention: Other: bolus Intermittent enteral feeding~semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins"
11298434|NCT03017079|OG001|Outcome|Intermittent Feeding|After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.
11298435|NCT03017079|OG000|Outcome|Intermittent Feeding With Semi-solid Nutrients|the initial feeds of 100 to 300mL every 4 to 8 hours and the semi-solid agent feeded before the EN application within 1 hour, which is low methoxy pectin gel and water-soluble dietary fiber form apple and citrus peel by binding to calcium ions in EN to increase the viscosity, but do not change any chemical properties of EN. This was repeated twice and, if tolerated, they were advanced by 100 to 300mL every 1 to 2 days to the volume goal.
11298436|NCT03017079|OG001|Outcome|Intermittent Feeding|The intermittent protocol involved initial feeds of 100 to 300mL every 4 to 8hours. This was repeated twice and, if tolerated, they were advanced by 100 to 300mL every 1 to 2 days to the volume goal. Each intermittent feeding was delivered via an enteral feeding pump during a 30- to 60-minute period of time.
11298437|NCT03017079|OG000|Outcome|Intermittent Feeding With Semi-solid Nutrients|"intermittent feeding with semi-solid nutrients:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.~Intervention: Other: bolus Intermittent enteral feeding~semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins"
11298438|NCT03017079|OG001|Outcome|Intermittent Feeding|"After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.~Intervention: Other: Standard enteral feeding~standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins"
11298439|NCT03017079|EG000|Reported Event|Standard Enteral Nutrition|We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found
11298440|NCT03017079|EG001|Reported Event|Semi-solidification With Nutrient|We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found
11298441|NCT03017235|BG000|Baseline|NaP/MC Oral Solution|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution~Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration"
11298442|NCT03017235|BG001|Baseline|PREPOPIK®|Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
11298443|NCT03017235|BG002|Baseline|Total|Total of all reporting groups
11298444|NCT03017235|FG000|Participant Flow|NaP/MC Oral Solution|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution~Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.~Split dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy."
11298445|NCT03017235|FG001|Participant Flow|PREPOPIK®|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject.~Split dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.~Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy."
11298446|NCT03017235|OG000|Outcome|NaP/MC Oral Solution|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution~Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration."
11298447|NCT03017235|OG001|Outcome|PREPOPIK®|Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
11298448|NCT03017235|EG000|Reported Event|NaP/MC Oral Solution|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution~Supplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration."
11298449|NCT03017235|EG001|Reported Event|PREPOPIK®|"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder~Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes."
11298450|NCT03017261|BG000|Baseline|TSolution One®|"This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.~TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts."
11298451|NCT03017261|FG000|Participant Flow|TSolution One®|"This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.~TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts."
11298452|NCT03017261|OG000|Outcome|TSolution One®|"This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.~TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts."
11298453|NCT03017261|EG000|Reported Event|TSolution One®|"This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.~TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts."
11332814|NCT03501277|BG003|Baseline|Sequence IV: DABC|Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).
11332815|NCT03501277|BG004|Baseline|Total|Total of all reporting groups
11332816|NCT03501277|FG000|Participant Flow|Sequence I: ABCD|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) fixed dose combination (FDC) tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
11332817|NCT03501277|FG001|Participant Flow|Sequence II: BCDA|Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
11332818|NCT03501277|FG002|Participant Flow|Sequence III: CDAB|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
11332819|NCT03501277|FG003|Participant Flow|Sequence IV: DABC|Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).
11332820|NCT03501277|OG000|Outcome|Regimen A|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332821|NCT03501277|OG001|Outcome|Regimen B|Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332822|NCT03501277|OG002|Outcome|Regimen C|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332823|NCT03501277|OG003|Outcome|Regimen D|Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332824|NCT03501277|EG000|Reported Event|Regimen A|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332825|NCT03501277|EG001|Reported Event|Regimen B|Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332826|NCT03501277|EG002|Reported Event|Regimen C|SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332827|NCT03501277|EG003|Reported Event|Regimen D|Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
11332828|NCT03501550|BG000|Baseline|Subjects|number of subjects in the study
11332829|NCT03501550|FG000|Participant Flow|CDI-31244 + SOF/VEL|"2 wks of CDI-31244 in combination with 6 wks of SOF/VEL~CDI-31244: investigational drug~SOF/VEL: sofosbuvir and velpatasvir fixed dose combination"
11332830|NCT03501550|OG000|Outcome|CDI-31244 + SOF/VEL|"2 wks of CDI-31244 in combination with 6 wks of SOF/VEL~CDI-31244: investigational drug~SOF/VEL: sofosbuvir and velpatasvir fixed dose combination"
11298454|NCT03017508|BG000|Baseline|Participants That Were Randomized to Receive BHV-0223 (Sublingual Riluzole) First|"Participants were given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.~BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours."
11298455|NCT03017508|BG001|Baseline|Participants That Were Randomized to Receive Placebo First|"Participants were given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.~Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours."
11298456|NCT03017508|BG002|Baseline|Total|Total of all reporting groups
11298457|NCT03017508|FG000|Participant Flow|Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo|Participants that were randomized to receive sublingual BHV-0223 before performing a 10 minute speech task and were then followed for 3 hours. Participants were then assessed every hour for the next three hours. There was a 2 to 10 days of washout period. These participants would then receive an identical looking sublingual placebo before performing a 10 minute speech task and were followed for 3 hours.
11298458|NCT03017508|FG001|Participant Flow|Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223|Participants that were randomized to receive sublingual placebo before performing a 10 minute speech task and were then followed for 3 hours. Participants were then assessed every hour for the next three hours. There was a 2 to 10 days of washout period. These participants would then receive sublingual BHV-0223 before performing a 10 minute speech task and were followed for 3 hours.
11332831|NCT03501550|EG000|Reported Event|CDI-31244 + SOF/VEL|"2 wks of CDI-31244 in combination with 6 wks of SOF/VEL~CDI-31244: investigational drug~SOF/VEL: sofosbuvir and velpatasvir fixed dose combination"
10971459|NCT00915590|FG000|Participant Flow|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971460|NCT00915590|FG001|Participant Flow|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971461|NCT00915590|OG000|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971462|NCT00915590|OG001|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971463|NCT00915590|OG000|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
10971464|NCT00915590|OG001|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
10971465|NCT00915590|OG000|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971466|NCT00915590|OG001|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
10971467|NCT00915590|EG000|Reported Event|Placebo|Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks
10971468|NCT00915590|EG001|Reported Event|IL-1Ra|IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
10971469|NCT00915590|EG002|Reported Event|Off Treatment|Off treatment
10971470|NCT00915603|BG000|Baseline|Paclitaxel/Carboplatin/Placebo|
10971471|NCT00915603|BG001|Baseline|Paclitaxel/Carboplatin/Everolimus|
10971472|NCT00915603|BG002|Baseline|Total|Total of all reporting groups
10971473|NCT00915603|FG000|Participant Flow|Paclitaxel/Carboplatin/Placebo|
10971474|NCT00915603|FG001|Participant Flow|Paclitaxel/Carboplatin/Everolimus|
10971475|NCT00915603|OG000|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
10971476|NCT00915603|OG001|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
10971477|NCT00915603|EG000|Reported Event|Paclitaxel/Bevacizumab/Everolimus|
10971478|NCT00915603|EG001|Reported Event|Paclitaxel/Bevacizumab/Placebo|
10971479|NCT00915655|BG000|Baseline|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
10971480|NCT00915655|FG000|Participant Flow|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
10971481|NCT00915655|OG000|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
11298459|NCT03017508|OG000|Outcome|BHV-0223 (Sublingual Riluzole)|"Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed immediately after finishing speech task.~BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task."
11298460|NCT03017508|OG001|Outcome|Placebo|"Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed immediately after finishing the speech task.~Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task."
11298461|NCT03017508|EG000|Reported Event|BHV-0223 (Sublingual Riluzole)|"Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed immediately after finishing speech task.~BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task."
11298462|NCT03017508|EG001|Reported Event|Placebo|"Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed immediately after finishing the speech task.~Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task."
11298463|NCT03017612|BG000|Baseline|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
11298464|NCT03017612|FG000|Participant Flow|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
11298465|NCT03017612|OG000|Outcome|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
11298466|NCT03017612|EG000|Reported Event|Single Arm Study|"Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects~Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision."
11298467|NCT03017846|BG000|Baseline|Cantharidin Treatment|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.~Cantharidin: Application of topical cantharidin"
11298468|NCT03017846|FG000|Participant Flow|Cantharidin Treatment|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.~Cantharidin: Application of topical cantharidin"
11298469|NCT03017846|OG000|Outcome|Cantharidin Treatment|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.~Cantharidin: Application of topical cantharidin"
11298470|NCT03017846|OG000|Outcome|Current Study|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the present study.~Cantharidin: Application of topical cantharidin"
11298471|NCT03017846|OG001|Outcome|NCT02665260|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.~Cantharidin: Application of topical cantharidin"
11298472|NCT03017846|EG000|Reported Event|Cantharidin Treatment|"Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.~Cantharidin: Application of topical cantharidin"
11298473|NCT03017924|BG000|Baseline|Collar Group|"Subjects that will wear the Q collar during the breacher training~Q collar: q-collar concussion prevention device"
11298474|NCT03017924|BG001|Baseline|Non-Collar Group|Subjects that will not wear the Q collar during the breacher training
11298475|NCT03017924|BG002|Baseline|Total|Total of all reporting groups
11298476|NCT03017924|FG000|Participant Flow|Collar Group|"Subjects that will wear the Q collar during the breacher training~Q collar: q-collar concussion prevention device"
11298477|NCT03017924|FG001|Participant Flow|Non-Collar Group|Subjects that will not wear the Q collar during the breacher training
11298478|NCT03017924|OG000|Outcome|Collar Group|"Subjects that will wear the Q collar during the breacher training~Q collar: q-collar concussion prevention device"
11298479|NCT03017924|OG001|Outcome|Non-Collar Group|Subjects that will not wear the Q collar during the breacher training
11298480|NCT03017924|OG000|Outcome|Q Collar|"Subjects that will wear the Q collar during the breacher training~Q collar: q-collar concussion prevention device"
11298481|NCT03017924|OG001|Outcome|No Collar|Subjects that will not wear the Q collar during the breacher training
11298482|NCT03017924|EG000|Reported Event|Collar Group|"Subjects that will wear the Q collar during the breacher training~Q collar: q-collar concussion prevention device"
11298483|NCT03017924|EG001|Reported Event|Non-Collar Group|Subjects that will not wear the Q collar during the breacher training
11298484|NCT03017937|BG000|Baseline|Q- Collar|"All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)~Q-collar: capture ultrasound images at each pressure point"
11298485|NCT03017937|FG000|Participant Flow|Q- Collar|"All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)~Q-collar: capture ultrasound images at each pressure point"
11298486|NCT03017937|OG000|Outcome|Females|"All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)~Q-collar: capture ultrasound images at each pressure point"
11298487|NCT03017937|OG001|Outcome|Males|"All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)~Q-collar: capture ultrasound images at each pressure point"
11298488|NCT03017937|EG000|Reported Event|Q- Collar|"All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)~Q-collar: capture ultrasound images at each pressure point"
11298489|NCT03018028|BG000|Baseline|Oral Semaglutide 3 mg|Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298490|NCT03018028|BG001|Baseline|Oral Semaglutide 7 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298491|NCT03018028|BG002|Baseline|Oral Semaglutide 14 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298492|NCT03018028|BG003|Baseline|Liraglutide 0.9 mg|Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
11298493|NCT03018028|BG004|Baseline|Placebo|Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298494|NCT03018028|BG005|Baseline|Total|Total of all reporting groups
11298495|NCT03018028|FG000|Participant Flow|Oral Semaglutide 3 mg|Participants received 3.0 milligrams (mg) of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298496|NCT03018028|FG001|Participant Flow|Oral Semaglutide 7 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298497|NCT03018028|FG002|Participant Flow|Oral Semaglutide 14 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298498|NCT03018028|FG003|Participant Flow|Liraglutide 0.9 mg|Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
11298499|NCT03018028|FG004|Participant Flow|Placebo|Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298500|NCT03018028|OG000|Outcome|Oral Semaglutide 3 mg|Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11332832|NCT03501693|BG000|Baseline|DBT Plus S-View and FFDM Alone|300 retrospectively collected breast images to be reviewed (both DBT plus S-View and FFDM alone for all 300 images)
11332833|NCT03501693|FG000|Participant Flow|DBT Plus S-View, Then FFDM Only|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332834|NCT03501693|FG001|Participant Flow|FFDM Only, Then DBT Plus S-View|Readers will read half of the FFDM images followed by half of the DBT plus S-Viewonly images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332835|NCT03501693|OG000|Outcome|DBT Plus S-View|"Breast images utilizing DBT plus S-View~DBT plus S-View: DBT plus S-View images"
11332836|NCT03501693|OG001|Outcome|FFDM Alone|"FFDM alone images~FFDM Alone: FFDM alone images"
11332837|NCT03501693|EG000|Reported Event|DBT Plus S-View|"Breast images utilizing DBT plus S-View~DBT plus S-View: DBT plus S-View images"
11298501|NCT03018028|OG001|Outcome|Oral Semaglutide 7 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298502|NCT03018028|OG002|Outcome|Oral Semaglutide 14 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298503|NCT03018028|OG003|Outcome|Liraglutide 0.9 mg|Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
11298504|NCT03018028|OG004|Outcome|Placebo|Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298505|NCT03018028|EG000|Reported Event|Oral Semaglutide 3 mg|Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298506|NCT03018028|EG001|Reported Event|Oral Semaglutide 7 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298507|NCT03018028|EG002|Reported Event|Oral Semaglutide 14 mg|Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298508|NCT03018028|EG003|Reported Event|Liraglutide 0.9 mg|Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
10971482|NCT00915655|EG000|Reported Event|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
11298509|NCT03018028|EG004|Reported Event|Placebo|Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
11298510|NCT03018106|BG000|Baseline|Ospemifene|Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
11298511|NCT03018106|BG001|Baseline|Estrogen|Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
11298512|NCT03018106|BG002|Baseline|Total|Total of all reporting groups
11298513|NCT03018106|FG000|Participant Flow|Ospemifene|Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
11298514|NCT03018106|FG001|Participant Flow|Estrogen|Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
11298515|NCT03018106|OG000|Outcome|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
11298516|NCT03018106|EG000|Reported Event|Estrogen|Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
11298517|NCT03018223|BG000|Baseline|Conditioning/HCT/GVHD Prophylaxis|Pre-HCT Conditioning, HCT, GVHD Prophylaxis.
11298518|NCT03018223|FG000|Participant Flow|Conditioning/HCT/GVHD Prophylaxis|Pre-HCT Conditioning, HCT, GVHD Prophylaxis.
11298519|NCT03018223|OG000|Outcome|Conditioning/HCT/GVHD Prophylaxis|Pre-HCT Conditioning, HCT, GVHD Prophylaxis.
11298520|NCT03018223|EG000|Reported Event|Conditioning/HCT/GVHD Prophylaxis|Pre-HCT Conditioning, HCT, GVHD Prophylaxis.
11298521|NCT03018249|BG000|Baseline|Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA|Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
11298522|NCT03018249|BG001|Baseline|Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat|Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
11298523|NCT03018249|BG002|Baseline|Total|Total of all reporting groups
11298524|NCT03018249|FG000|Participant Flow|Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA|Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
10971483|NCT00915759|BG000|Baseline|ProKera and Bandage Contact Lens|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
11298525|NCT03018249|FG001|Participant Flow|Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat|Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
11298526|NCT03018249|OG000|Outcome|Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA|Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
11298527|NCT03018249|OG001|Outcome|Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat|Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
11298528|NCT03018249|EG000|Reported Event|Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA|Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.
11298529|NCT03018249|EG001|Reported Event|Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat|Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
11298530|NCT03018340|BG000|Baseline|Pimavanserin 34 mg + SSRI/SNRI|Patients randomized to Pimavanserin at the beginning of Stage 1. Patients on Pimavanserin remained on their assigned treatment throughout Stage 1 and 2 of the study. Pimavanserin 34 mg (2 x 17 mg), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298531|NCT03018340|BG001|Baseline|Placebo + SSRI/SNRI|"Patients randomized to Placebo at the beginning of Stage 1. This group includes all patients randomized to placebo in Stage 1, irrespective of response in Stage 1 and later rerandomization to Pimavanserin or Placebo in Stage 2.~Placebo (2 x Placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study."
11298532|NCT03018340|BG002|Baseline|Total|Total of all reporting groups
11298533|NCT03018340|FG000|Participant Flow|Pimavanserin 34 mg + SSRI/SNRI|"Patients randomized to Pimavanserin at the beginning of Stage 1. Patients on Pimavanserin remained on their assigned treatment throughout Stage 1 and 2 of the study.~Pimavanserin 34 mg (2 x 17 mg), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study."
11298534|NCT03018340|FG001|Participant Flow|Placebo + SSRI/SNRI|"Patients randomized to Placebo at the beginning of Stage 1. This group includes all patients randomized to placebo in Stage 1, irrespective of response in Stage 1 and later rerandomization to Pimavanserin or Placebo in Stage 2.~Placebo (2 x Placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study."
11298535|NCT03018340|OG000|Outcome|Pimavanserin 34 mg + SSRI/SNRI, Stage 1|Patients randomized to Pimavanserin at the beginning of Stage 1. Patients on Pimavanserin remained on their assigned treatment throughout Stage 1 and 2 of the study. Pimavanserin 34 mg (2 x 17 mg), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298536|NCT03018340|OG001|Outcome|Placebo + SSRI/SNRI, Stage 1|Patients randomized to Placebo at the beginning of Stage 1. This group includes all patients randomized to placebo in Stage 1, irrespective of response in Stage 1 and later rerandomization to Pimavanserin or Placebo in Stage 2. Placebo (2 x Placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11332838|NCT03501693|EG001|Reported Event|FFDM Alone|"FFDM alone images~FFDM Alone: FFDM alone images"
11298537|NCT03018340|OG002|Outcome|Pimavanserin 34 mg + SSRI/SNRI, Stage 2|Patients rerandomized to Pimavanserin 34 mg at the beginning of Stage 2. Patients represent a subset of the placebo patients not responding to treatment (by protocol-defined criteria) in Stage 1, who were then randomly assigned (1:1) to pimavanserin or placebo in Stage 2. Pimavanserin 34 mg (2 x 17 mg tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298538|NCT03018340|OG003|Outcome|Placebo + SSRI/SNRI, Stage 2|Patients rerandomized to Placebo at the beginning of Stage 2. Patients represent a subset of the placebo patients not responding to treatment (by protocol-defined criteria) in Stage 1 who were then randomly assigned (1:1) to pimavanserin or placebo in Stage 2. Placebo (2 x placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298539|NCT03018340|EG000|Reported Event|Pimavanserin 34 mg + SSRI/SNRI, Stage 1|Patients randomized to Pimavanserin at the beginning of Stage 1. Patients on Pimavanserin remained on their assigned treatment throughout Stage 1 and 2 of the study. Pimavanserin 34 mg (2 x 17 mg), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298540|NCT03018340|EG001|Reported Event|Placebo + SSRI/SNRI, Stage 1|"Patients randomized to Placebo at the beginning of Stage 1. This group includes all patients randomized to placebo in Stage 1, irrespective of response in Stage 1 and later rerandomization to Pimavanserin or Placebo in Stage 2.~Placebo (2 x Placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study."
11298541|NCT03018340|EG002|Reported Event|Pimavanserin 34 mg + SSRI/SNRI, Stage 2|Patients rerandomized to Pimavanserin 34 mg at the beginning of Stage 2. Patients represent a subset of the placebo patients not responding to treatment (by protocol-defined criteria) in Stage 1, who were then randomly assigned (1:1) to pimavanserin or placebo in Stage 2. Pimavanserin 34 mg (2 x 17 mg tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298542|NCT03018340|EG003|Reported Event|Placebo + SSRI/SNRI, Stage 2|Patients rerandomized to Placebo at the beginning of Stage 2. Patients represent a subset of the placebo patients not responding to treatment (by protocol-defined criteria) in Stage 1 who were then randomly assigned (1:1) to pimavanserin or placebo in Stage 2. Placebo (2 x placebo tablets), once daily by mouth. All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
11298543|NCT03018691|BG000|Baseline|0.3% OPA-15406 Ointments|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406"
11298544|NCT03018691|BG001|Baseline|1% OPA-15406 Ointments|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406"
11298545|NCT03018691|BG002|Baseline|Placebo Ointments|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebos"
11298546|NCT03018691|BG003|Baseline|Total|Total of all reporting groups
11298547|NCT03018691|FG000|Participant Flow|0.3% OPA-15406 Ointments|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406"
11298548|NCT03018691|FG001|Participant Flow|1% OPA-15406 Ointments|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406"
11298549|NCT03018691|FG002|Participant Flow|Placebo Ointments|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebos"
11298550|NCT03018691|OG000|Outcome|0.3% OPA-15406 Ointments|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406"
11298551|NCT03018691|OG001|Outcome|1% OPA-15406 Ointments|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406"
11298552|NCT03018691|OG002|Outcome|Placebo Ointments|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebos"
11298553|NCT03018691|OG000|Outcome|0.3% OPA-15406|Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
11298554|NCT03018691|OG001|Outcome|1% OPA-15406|Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
11298555|NCT03018691|EG000|Reported Event|0.3% OPA-15406 Ointments|"Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.~OPA-15406"
11298556|NCT03018691|EG001|Reported Event|1% OPA-15406 Ointments|"Subjects were treated with assigned 1% OPA-15406 ointment twice daily.~OPA-15406"
11298557|NCT03018691|EG002|Reported Event|Placebo Ointments|"Subjects were treated with assigned 0% OPA-15406 ointment twice daily.~Placebos"
11298558|NCT03018925|BG000|Baseline|Ulcerative Colitis|"The proposed study will include 15 UC anti-TNF naïve patients . We will consider remission when patients have an endoscopic Mayo score ≤1, and activity index score, Mayo= 0 points.~Stool samples will be collected before starting Anti-TNF treatment (M0), and then every 3 months (M1, M2, M3 and M4) to complete the study.~GOLIMUMAB induction with 200mg at week 0, and 100mg at week 2. Under 70kg, the follow up treatment will be 50mg/month, and 100mg/month in patients over 70kg, as clinical practice.~Golimumab"
11332839|NCT03502265|BG000|Baseline|Otteroo Adjunct|"A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms.~Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided."
11332840|NCT03502265|FG000|Participant Flow|Otteroo Adjunct|"A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms.~Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided."
11298559|NCT03018925|FG000|Participant Flow|Ulcerative Colitis|"A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A), 4 weeks (B), 2 months after (C), 3 months (D), 6 months (E), 9 months (F) and finally 1 year after starting treatment (G). The monitoring period was one year long.~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298560|NCT03018925|OG000|Outcome|Ulcerative Colitis Baseline|"A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298561|NCT03018925|OG001|Outcome|Ulcerative Colitis Week 4|"A total of 15 patients were included in the study. Stool samples were collected at week 4 after treatment (B).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298562|NCT03018925|OG002|Outcome|Ulcerative Colitis Week 9|"A total of 15 patients were included in the study. Stool samples were collected at week 9 after (C) starting treatment.~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298563|NCT03018925|OG003|Outcome|Ulcerative Colitis Week 13|"A total of 15 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298564|NCT03018925|OG004|Outcome|Ulcerative Colitis Week 26|"A total of 15 patients were included in the study. Stool samples were collected at week 24 after starting treatment (E).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298565|NCT03018925|OG005|Outcome|Ulcerative Colitis Week 39|"A total of 15 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298566|NCT03018925|OG006|Outcome|Ulcerative Colitis Week 52|"A total of 15 patients were included in the study. Stool samples were collected at week 52 after starting treatment.~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298567|NCT03018925|OG000|Outcome|Ulcerative Colitis Baseline|"A total of 9 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298568|NCT03018925|OG001|Outcome|Ulcerative Colitis Week 4|"A total of 9 patients were included in the study. Stool samples were collected at week 4 after starting treatment (B).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298569|NCT03018925|OG002|Outcome|Ulcerative Colitis Week 9|"A total of 9 patients were included in the study. Stool samples were collected at week 9 after starting treatment (C).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298570|NCT03018925|OG003|Outcome|Ulcerative Colitis Week 13|"A total of 9 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298571|NCT03018925|OG004|Outcome|Ulcerative Colitis Week 26|"A total of 9 patients were included in the study. Stool samples were collected at week 26 after starting treatment (E).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298572|NCT03018925|OG005|Outcome|Ulcerative Colitis Week 39|"A total of 9 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298573|NCT03018925|OG006|Outcome|Ulcerative Colitis Week 52|"A total of 9 patients were included in the study. Stool samples were collected at week 52 after starting treatment (G).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298574|NCT03018925|OG000|Outcome|Partial Mayo Score Baseline|A total of 15 patients were included in the study. Partial Mayo scores were collected from patients before starting Golimumab treatment (week 0)
11298575|NCT03018925|OG001|Outcome|Partial Mayo Score at Week 52|A total of 15 patients were included in the study. Partial Mayo scores were collected from patients at week 52 (G) after starting Golimumab treatment.
11298576|NCT03018925|EG000|Reported Event|Ulcerative Colitis Baseline|"A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11332841|NCT03502265|OG000|Outcome|Otteroo Adjunct|"A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms.~Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided."
10971484|NCT00915759|FG000|Participant Flow|ProKera/Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
10971485|NCT00915759|OG000|Outcome|ProKera|Group 1: ProKera in place until complete corneal re-repithelialization (healing)
10971486|NCT00915759|OG001|Outcome|Bandage Contact Lens|Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
11298577|NCT03018925|EG001|Reported Event|Ulcerative Colitis Week 4|"A total of 15 patients were included in the study. Stool samples were collected at week 4 after starting treatment (B).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298578|NCT03018925|EG002|Reported Event|Ulcerative Colitis Week 9|"A total of 15 patients were included in the study. Stool samples were collected at week 8 after starting treatment (C).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298579|NCT03018925|EG003|Reported Event|Ulcerative Colitis Week 13|"A total of 15 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298580|NCT03018925|EG004|Reported Event|Ulcerative Colitis Week 26|"A total of 15 patients were included in the study. Stool samples were collected at week 26 after starting treatment (E).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298581|NCT03018925|EG005|Reported Event|Ulcerative Colitis Week 39|"A total of 15 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298582|NCT03018925|EG006|Reported Event|Ulcerative Colitis Week 52|"A total of 15 patients were included in the study. Stool samples were collected at week 52 after starting treatment (G).~Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.~Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis."
11298583|NCT03018938|BG000|Baseline|Insulin Analog Mid Mixture|Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
11298584|NCT03018938|BG001|Baseline|Basal Insulin Analog|Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
11298585|NCT03018938|BG002|Baseline|Total|Total of all reporting groups
11298586|NCT03018938|FG000|Participant Flow|Insulin Analog Mid Mixture|Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
11298587|NCT03018938|FG001|Participant Flow|Basal Insulin Analog|Participants received Basal insulin analog given subcutaneously (SC) once daily (QD) at the discretion of the investigator.
11298588|NCT03018938|OG000|Outcome|Insulin Analog Mid Mixture|Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
11298589|NCT03018938|OG001|Outcome|Basal Insulin Analog|Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
11298590|NCT03018938|EG000|Reported Event|Insulin Analog Mid Mixture|Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
11298591|NCT03018938|EG001|Reported Event|Basal Insulin Analog|Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
11298592|NCT03019055|BG000|Baseline|CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)"
10971487|NCT00915759|OG000|Outcome|ProKera|Group 2: ProKera in place until postoperative day 3
11298593|NCT03019055|BG001|Baseline|CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg"
11298594|NCT03019055|BG002|Baseline|CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)~Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)"
11298595|NCT03019055|BG003|Baseline|CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection."
11298596|NCT03019055|BG004|Baseline|Total|Total of all reporting groups
11298597|NCT03019055|FG000|Participant Flow|CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)"
11298598|NCT03019055|FG001|Participant Flow|CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg"
11298599|NCT03019055|FG002|Participant Flow|CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)~Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)"
11298600|NCT03019055|FG003|Participant Flow|CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection."
11298601|NCT03019055|OG000|Outcome|CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)"
10971488|NCT00915759|OG001|Outcome|Bandage Contact Lens|Group 2: bandage contact lens in place until postoperative day 3
10971489|NCT00915759|OG000|Outcome|ProKera|Group 3: ProKera in place until postoperative day 1
10971490|NCT00915759|OG001|Outcome|Bandage Contact Lens|Group 3: bandage contact lens in place until postoperative day 1
10971491|NCT00915759|EG000|Reported Event|ProKera|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
10971492|NCT00915759|EG001|Reported Event|Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
10971493|NCT00915772|BG000|Baseline|M1000|Metformin 1000mg monotherapy twice daily
11298602|NCT03019055|OG001|Outcome|CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg"
11298603|NCT03019055|OG002|Outcome|CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)~Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)"
11298604|NCT03019055|OG003|Outcome|CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection."
11298605|NCT03019055|EG000|Reported Event|CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)"
11298606|NCT03019055|EG001|Reported Event|CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg"
11298607|NCT03019055|EG002|Reported Event|CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.~Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)~Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)"
11298608|NCT03019055|EG003|Reported Event|CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)|"Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.~CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection."
11298609|NCT03019107|BG000|Baseline|VentFree Stimulation|"Breath synchronized abdominal NMES~Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298610|NCT03019107|BG001|Baseline|Sham Stimulation|"Sham breath synchronized abdominal NMES~Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298611|NCT03019107|BG002|Baseline|Total|Total of all reporting groups
11298612|NCT03019107|FG000|Participant Flow|VentFree Stimulation|"Breath synchronized abdominal NMES~Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
10971494|NCT00915772|BG001|Baseline|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
11298613|NCT03019107|FG001|Participant Flow|Sham Stimulation|"Sham breath synchronized abdominal NMES~Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298614|NCT03019107|OG000|Outcome|VentFree Stimulation|"Breath synchronized abdominal NMES~Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298615|NCT03019107|OG001|Outcome|Sham Stimulation|"Sham breath synchronized abdominal NMES~Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298616|NCT03019107|EG000|Reported Event|VentFree Stimulation|"Breath synchronized abdominal NMES~Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298617|NCT03019107|EG001|Reported Event|Sham Stimulation|"Sham breath synchronized abdominal NMES~Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation."
11298618|NCT03019289|BG000|Baseline|A: Cohort 1: P90 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298619|NCT03019289|BG001|Baseline|A: Cohort 2: P45 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298620|NCT03019289|BG002|Baseline|A: Cohort 2: P22.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298621|NCT03019289|BG003|Baseline|A: Cohort 3: P5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298622|NCT03019289|BG004|Baseline|A: Cohort 7: P1 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298623|NCT03019289|BG005|Baseline|A: Cohort 7: P0.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298624|NCT03019289|BG006|Baseline|A: Cohort 6; P90 + (S)-(-)-FPD; HD|Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298625|NCT03019289|BG007|Baseline|B: Cohort 4: P90 + Fallypride; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298626|NCT03019289|BG008|Baseline|Cohort 0: (S)-(-)-FPD, HV|Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging
11298627|NCT03019289|BG009|Baseline|Total|Total of all reporting groups
11298628|NCT03019289|FG000|Participant Flow|A: Cohort 1: P90 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298629|NCT03019289|FG001|Participant Flow|A: Cohort 2: P45 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298630|NCT03019289|FG002|Participant Flow|A: Cohort 2: P22.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298631|NCT03019289|FG003|Participant Flow|A: Cohort 3: P5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
10971495|NCT00915772|BG002|Baseline|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
10971496|NCT00915772|BG003|Baseline|Total|Total of all reporting groups
10971497|NCT00915772|FG000|Participant Flow|M1000|Metformin 1000mg monotherapy twice daily
10971498|NCT00915772|FG001|Participant Flow|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
10971499|NCT00915772|FG002|Participant Flow|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
10971500|NCT00915772|OG000|Outcome|M1000|Metformin 1000mg monotherapy twice daily
11298632|NCT03019289|FG004|Participant Flow|A: Cohort 7: P1 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298633|NCT03019289|FG005|Participant Flow|A: Cohort 7: P0.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298634|NCT03019289|FG006|Participant Flow|A: Cohort 6; P90 + (S)-(-)-FPD; HD|Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298635|NCT03019289|FG007|Participant Flow|B: Cohort 4: P90 + Fallypride; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298636|NCT03019289|FG008|Participant Flow|Cohort 0: (S)-(-)-FPD, HV|Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging
11298637|NCT03019289|OG000|Outcome|A: Cohort 1: P90 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298638|NCT03019289|OG001|Outcome|A: Cohort 2: P45 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298639|NCT03019289|OG002|Outcome|A: Cohort 2: P22.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298640|NCT03019289|OG003|Outcome|A: Cohort 3: P5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298641|NCT03019289|OG004|Outcome|A: Cohort 7: P1 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
10971501|NCT00915772|OG001|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
10971502|NCT00915772|OG002|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
10971503|NCT00915772|OG003|Outcome|Post-treat|7 days follow-up period
10971504|NCT00915772|EG000|Reported Event|M1000|Metformin 1000 mg twice daily
10971505|NCT00915772|EG001|Reported Event|L2.5+M500|Linagliptin 2.5 mg + Metformin 500 mg twice daily
10971506|NCT00915772|EG002|Reported Event|L2.5+M1000|Linagliptin 2.5 mg + Metformin 1000 mg twice daily
10971507|NCT00915798|BG000|Baseline|ADHD Smokers|ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
10971508|NCT00915798|BG001|Baseline|ADHD Nonsmokers|ADHD nonsmokers participated in the abstinence condition.
10971509|NCT00915798|BG002|Baseline|Control Smokers|Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
10971510|NCT00915798|BG003|Baseline|Control Nonsmokers|Control nonsmokers participated in the abstinence condition.
11298642|NCT03019289|OG005|Outcome|A: Cohort 7: P0.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298643|NCT03019289|OG006|Outcome|A: Cohort 6; P90 + (S)-(-)-FPD; HD|Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298644|NCT03019289|OG007|Outcome|B: Cohort 4: P90 + FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298645|NCT03019289|OG007|Outcome|B: Cohort 4: P90 + Fallypride; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298646|NCT03019289|OG000|Outcome|B: Cohort 4: P90 + FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298647|NCT03019289|EG000|Reported Event|A: Cohort 1: P90 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298648|NCT03019289|EG001|Reported Event|A: Cohort 2: P45 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298649|NCT03019289|EG002|Reported Event|A: Cohort 2: P22.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298650|NCT03019289|EG003|Reported Event|A: Cohort 3: P5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298651|NCT03019289|EG004|Reported Event|A: Cohort 7: P1 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298652|NCT03019289|EG005|Reported Event|A: Cohort 7: P0.5 + (S)-(-)-FPD; HV|Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298653|NCT03019289|EG006|Reported Event|A: Cohort 6; P90 + (S)-(-)-FPD; HD|Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study
11298654|NCT03019289|EG007|Reported Event|B: Cohort 4: P90 + Fallypride; HV|Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study
11298655|NCT03019289|EG008|Reported Event|Cohort 0: (S)-(-)-FPD, HV|Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging
11298656|NCT03019458|BG000|Baseline|MINGO|"MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary~MINGO: 6 20oz sachets will be taken daily by intervention group"
11298657|NCT03019458|BG001|Baseline|Control|The control group is required to eat their normal diet. They are also required to keep a daily food diary.
11298658|NCT03019458|BG002|Baseline|Total|Total of all reporting groups
11298659|NCT03019458|FG000|Participant Flow|MINGO|"MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary~MINGO: 6 20oz sachets will be taken daily by intervention group.~There were 24 subjects who were part of the MINGO arm."
11298660|NCT03019458|FG001|Participant Flow|Control|The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group
11298661|NCT03019458|OG000|Outcome|MINGO|"MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary~MINGO: 6 20oz sachets will be taken daily by intervention group.~There were 24 subjects who were part of the MINGO arm."
11298662|NCT03019458|OG001|Outcome|Control|The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group
11298663|NCT03019458|OG000|Outcome|MINGO|"MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary~MINGO: 6 20oz sachets will be taken daily by intervention group"
11298664|NCT03019458|OG001|Outcome|Control|The control group is required to eat their normal diet. They are also required to keep a daily food diary.
10971511|NCT00915798|BG004|Baseline|Total|Total of all reporting groups
10971512|NCT00915798|FG000|Participant Flow|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
11298665|NCT03019458|EG000|Reported Event|MINGO|"MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary~MINGO: 6 20oz sachets will be taken daily by intervention group"
11298666|NCT03019458|EG001|Reported Event|Control|The control group is required to eat their normal diet. They are also required to keep a daily food diary.
11298667|NCT03019549|BG000|Baseline|Overall Study|All participants who received at least 1 dose of study drug.
11298668|NCT03019549|FG000|Participant Flow|Overall Study|All participants received: Period 1, Day 1: single, PO dose 20 mg rosuvastatin with a seven day wash-out. Period 2: Day 1-7 single, PO dose 50 mg lanabecestat (LY3314814) with a single 20 mg rosuvastatin dose coadminstered on Day 8
11298669|NCT03019549|OG000|Outcome|Rosuvastatin|20 mg rosuvastatin administered PO
11298670|NCT03019549|OG001|Outcome|Rosuvastatin + Lanabecestat (LY3314814)|20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination.
11298671|NCT03019549|OG000|Outcome|Lanabecestat (LY3314814)|50 mg lanabecestat (LY3314814) PO once daily (QD)
11298672|NCT03019549|OG001|Outcome|Rosuvastatin + Lanabecestat (LY3314814)|20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination PO
11298673|NCT03019549|EG000|Reported Event|20 mg Rosuvastatin|Period 1: rosuvastatin: 20 mg PO on Day 1
11298674|NCT03019549|EG001|Reported Event|50 mg Lanabecestat (LY3314814)|Period 2: Day 1-7,50 mg lanabecestat (LY3314814) PO once daily (QD)
11298675|NCT03019549|EG002|Reported Event|Lanabecestat (LY3314814) + 20 mg Rosuvastatin|Period 2: Lanabecestat (LY3314814) 50 mg PO Days 1-12 with a single dose of 20 mg rosuvastatin PO on Day 8
11298676|NCT03019627|BG000|Baseline|rhNGF 20μg/mL|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~NGF: Eye Drop 20 μg/mL"
11298677|NCT03019627|BG001|Baseline|Vehicle|"vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11298678|NCT03019627|BG002|Baseline|Total|Total of all reporting groups
11298679|NCT03019627|FG000|Participant Flow|rhNGF 20μg/mL|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~NGF: Eye Drop 20 μg/mL"
11298680|NCT03019627|FG001|Participant Flow|Vehicle|"vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11298681|NCT03019627|OG000|Outcome|rhNGF 20μg/mL|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~NGF: Eye Drop 20 μg/mL"
11298682|NCT03019627|OG001|Outcome|Vehicle|"vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11298683|NCT03019627|EG000|Reported Event|rhNGF 20μg/mL|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~NGF: Eye Drop 20 μg/mL"
11298684|NCT03019627|EG001|Reported Event|Vehicle|"vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
10971513|NCT00915798|FG001|Participant Flow|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
11298685|NCT03019744|BG000|Baseline|MeCFES|"25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation~MeCFES-assisted task-oriented upper limb rehabilitation"
11298686|NCT03019744|BG001|Baseline|Control|"25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation~Usual Care task-oriented upper limb rehabilitation"
11298687|NCT03019744|BG002|Baseline|Total|Total of all reporting groups
11298688|NCT03019744|FG000|Participant Flow|MeCFES|"25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation~MeCFES-assisted task-oriented upper limb rehabilitation"
11298689|NCT03019744|FG001|Participant Flow|Control|"25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation~Usual Care task-oriented upper limb rehabilitation"
11298690|NCT03019744|OG000|Outcome|MeCFES|"25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation~MeCFES-assisted task-oriented upper limb rehabilitation"
11298691|NCT03019744|OG001|Outcome|Control|"25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation~Usual Care task-oriented upper limb rehabilitation"
11298692|NCT03019744|EG000|Reported Event|MeCFES|"25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation~MeCFES-assisted task-oriented upper limb rehabilitation"
11298693|NCT03019744|EG001|Reported Event|Control|"25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation~Usual Care task-oriented upper limb rehabilitation"
11298694|NCT03019783|BG000|Baseline|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
11298695|NCT03019783|BG001|Baseline|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
11298696|NCT03019783|BG002|Baseline|Total|Total of all reporting groups
11298697|NCT03019783|FG000|Participant Flow|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
11298698|NCT03019783|FG001|Participant Flow|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
11298699|NCT03019783|OG000|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
11298700|NCT03019783|OG001|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
11298701|NCT03019783|EG000|Reported Event|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
11298702|NCT03019783|EG001|Reported Event|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
11298703|NCT03019796|BG000|Baseline|PRE-POST TRAINING|"In this cross over design, participants will be tested PRE and POST 4 months of endurance training.~They will be tested while taking their habitual medication on one occasion and in the other, the investigators will withhold their medication during 72 h to achieve 4 conditions:~Untrained, no medicated.~Untrained, medicated.~a) Trained, no medicated. b) Trained, medicated."
11298704|NCT03019796|FG000|Participant Flow|MEDICATED FIRST THEN PLACEBO|Subjects will remain taking their habitual antihypertensive medication during this time. After this first test, they will receive placebo during 72 h and will be tested again.
11298705|NCT03019796|FG001|Participant Flow|PLACEBO FIRST THEN MEDICATED|Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo. Then their habitual medication will be restated and they will be tested again.
11298706|NCT03019796|OG000|Outcome|MEDICATED|Subjects will take their habitual dose of antihypertensive medication.
11298707|NCT03019796|OG001|Outcome|PLACEBO|Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
11298708|NCT03019796|OG000|Outcome|MEDICATED|Subjects will be tested while taking their habitual antihypertensive medication.
11298709|NCT03019796|EG000|Reported Event|MEDICATED vs NO MEDICATED BEFORE TRAINING|"Subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h.~Untrained, no medicated.~Untrained, medicated."
11298710|NCT03019796|EG001|Reported Event|MEDICATED vs NO MEDICATED AFTER EXERCISE TRAINING|"After 4 months of endurance training subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h.~c) Trained, no medicated. d) Trained, medicated."
11298711|NCT03019887|BG000|Baseline|Reduction Group|Group of patients with schizophrenia undergoing high-dose therapy (>1000-mg chlorpromazine eq./day) We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day.
11298712|NCT03019887|FG000|Participant Flow|Dose Reduction|patients who reduced dose of antipsychotics
11298713|NCT03019887|OG000|Outcome|Dose Reduction|patients who reduced dose of antipsychotics
11298714|NCT03019887|EG000|Reported Event|Dose Reduction|patients who reduced dose of antipsychotics
11298715|NCT03019939|BG000|Baseline|Prevention (Isavuconazole)|"Patients receive isavuconazole PO every 8 hours for 6 doses and then QD or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.~Isavuconazole: Given PO or IV"
11298716|NCT03019939|FG000|Participant Flow|Prevention (Isavuconazole)|"Patients receive isavuconazole PO every 8 hours for 6 doses and then QD or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.~Isavuconazole: Given PO or IV"
11298717|NCT03019939|OG000|Outcome|Prevention (Isavuconazole)|"Patients receive isavuconazole PO every 8 hours for 6 doses and then QD or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.~Isavuconazole: Given PO or IV"
11298718|NCT03019939|EG000|Reported Event|Prevention (Isavuconazole)|"Patients receive isavuconazole PO every 8 hours for 6 doses and then QD or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.~Isavuconazole: Given PO or IV"
11298719|NCT03019965|BG000|Baseline|Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem|"Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.~Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.~Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.~Intermittent Imipenem: Imipenem administered in 60 minutes infusion.~Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.~Intermittent Meropenem: Meropenem administered in 60 minutes infusion."
11298720|NCT03019965|BG001|Baseline|Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem|"Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.~Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.~Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.~Extended Imipenem: Imipenem administered in 6 hours infusion.~Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.~Extended Meropenem: Meropenem administered in 8 hours infusion."
11298721|NCT03019965|BG002|Baseline|Total|Total of all reporting groups
11298722|NCT03019965|FG000|Participant Flow|Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem|"Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.~Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.~Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.~Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.~Intermittent Meropenem: Meropenem administered in 60 minutes infusion."
11298723|NCT03019965|FG001|Participant Flow|Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem|"Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.~Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.~Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.~Extended Imipenem: Imipenem administered in 6 hours infusion.~Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.~Extended Meropenem: Meropenem administered in 8 hours infusion."
11298724|NCT03019965|OG000|Outcome|Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem|"Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.~Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.~Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.~Intermittent Imipenem: Imipenem administered in 60 minutes infusion.~Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.~Intermittent Meropenem: Meropenem administered in 60 minutes infusion."
11298725|NCT03019965|OG001|Outcome|Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem|"Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.~Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.~Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.~Extended Imipenem: Imipenem administered in 6 hours infusion.~Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.~Extended Meropenem: Meropenem administered in 8 hours infusion."
10971514|NCT00915798|FG002|Participant Flow|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
10971515|NCT00915798|FG003|Participant Flow|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
11298726|NCT03019965|EG000|Reported Event|Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem|"Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.~Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.~Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.~Intermittent Imipenem: Imipenem administered in 60 minutes infusion.~Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.~Intermittent Meropenem: Meropenem administered in 60 minutes infusion."
11298727|NCT03019965|EG001|Reported Event|Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem|"Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.~Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.~Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.~Extended Imipenem: Imipenem administered in 6 hours infusion.~Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.~Extended Meropenem: Meropenem administered in 8 hours infusion."
11298728|NCT03020004|BG000|Baseline|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
11298729|NCT03020004|FG000|Participant Flow|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
11298730|NCT03020004|OG000|Outcome|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
11298731|NCT03020004|EG000|Reported Event|Danoprevir,Ritonavir, Peg-IFN,RBV|"Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.~Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly~Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)"
11298732|NCT03020069|BG000|Baseline|Glucose Meter|"Continuing Glucose Monitoring Device~CGMS Device"
11298733|NCT03020069|BG001|Baseline|No Glucose Meter|"Average Blood glucose measure~No Device"
11298734|NCT03020069|BG002|Baseline|Total|Total of all reporting groups
11298735|NCT03020069|FG000|Participant Flow|Glucose Meter|"Continuing Glucose Monitoring Device~CGMS Device"
11298736|NCT03020069|FG001|Participant Flow|No Glucose Meter|"Average Blood glucose measure~No Device"
11298737|NCT03020069|OG000|Outcome|Glucose Meter|"Continuing Glucose Monitoring Device~CGMS Device"
11298738|NCT03020069|OG001|Outcome|No Glucose Meter|"Average Blood glucose measure~No Device"
11298739|NCT03020069|EG000|Reported Event|Glucose Meter|"Continuing Glucose Monitoring Device~CGMS Device"
11298740|NCT03020069|EG001|Reported Event|No Glucose Meter|"Average Blood glucose measure~No Device"
11298741|NCT03020082|BG000|Baseline|Danoprevir, Ritonavir, Peg-IFN,RBV|"Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.~Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;~Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks;~peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;~RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks."
10971516|NCT00915798|OG000|Outcome|Smokers With ADHD After Abstinence|Smokers with ADHD after overnight abstinence (withdrawal).
10971517|NCT00915798|OG001|Outcome|Nonsmokers With ADHD|Nonsmokers participate in one condition.
10971518|NCT00915798|OG002|Outcome|Control Smokers After Abstinence|Control smokers after overnight abstinence (withdrawal).
10971519|NCT00915798|OG003|Outcome|Control Nonsmokers|Nonsmokers participate in one condition.
10971520|NCT00915798|OG004|Outcome|Smokers With ADHD After Smoking|Smokers with ADHD after smoking the first cigarette of the day
10971521|NCT00915798|OG005|Outcome|Control Smokers After Smoking|Control smokers after smoking the first cigarette of the day
10971522|NCT00915798|OG000|Outcome|Smokers With ADHD|Smokers with ADHD provided a blood sample.
10971523|NCT00915798|OG001|Outcome|Nonsmokers With ADHD|Nonsmokers with ADHD provided a blood sample.
10971524|NCT00915798|OG002|Outcome|Control Smokers|Control smokers provided a blood sample.
10971525|NCT00915798|OG003|Outcome|Control Nonsmokers|Control nonsmokers provided a blood sample.
10971526|NCT00915798|OG000|Outcome|ADHD Smokers|
10971527|NCT00915798|OG001|Outcome|ADHD Nonsmokers|
10971528|NCT00915798|OG002|Outcome|Control Smokers|
10971529|NCT00915798|OG003|Outcome|Control Nonsmokers|
10971530|NCT00915798|EG000|Reported Event|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
10971531|NCT00915798|EG001|Reported Event|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
10971532|NCT00915798|EG002|Reported Event|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each participant will undergo an fMRI scan during an experimental task consisting of mathematical problems and unpleasant and neutral pictures. Smokers will undergo two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
10971533|NCT00915798|EG003|Reported Event|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
10971534|NCT00915876|BG000|Baseline|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
10971535|NCT00915876|BG001|Baseline|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
10971536|NCT00915876|BG002|Baseline|Total|Total of all reporting groups
10971537|NCT00915876|FG000|Participant Flow|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
10971538|NCT00915876|FG001|Participant Flow|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
10971539|NCT00915876|OG000|Outcome|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
10971540|NCT00915876|OG001|Outcome|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
10971541|NCT00915876|EG000|Reported Event|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
10971542|NCT00915876|EG001|Reported Event|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
10971543|NCT00915902|BG000|Baseline|Treatment (Lovaza) Followed by Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
10971544|NCT00915902|BG001|Baseline|Placebo Followed by Treatment (Lovaza)|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
10971545|NCT00915902|BG002|Baseline|Total|Total of all reporting groups
10971546|NCT00915902|FG000|Participant Flow|Lovaza Then Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
10971547|NCT00915902|FG001|Participant Flow|Placebo Then Lovaza|Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
10971548|NCT00915902|OG000|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
10971549|NCT00915902|OG001|Outcome|Placebo|Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
10971550|NCT00915902|EG000|Reported Event|Treatment (Lovaza) Followed by Placebo, During Treatment|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
10971551|NCT00915902|EG001|Reported Event|Treatment (Lovaza) Followed by Placebo, During Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
10971552|NCT00915902|EG002|Reported Event|Placebo Followed by Treatment (Lovaza), During Placebo|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
10971553|NCT00915902|EG003|Reported Event|Placebo Followed by Treatment (Lovaza), During Treatment|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
10971554|NCT00915928|BG000|Baseline|Placebo|three months placebo treatment after surgical CSDH evacuation
10971555|NCT00915928|BG001|Baseline|Perindopril|three months perindopril treatment after surgical CSDH evacuation
10971556|NCT00915928|BG002|Baseline|Total|Total of all reporting groups
10971557|NCT00915928|FG000|Participant Flow|ACE Inhibitor|Perindopril: 2,5 mg daily for 3 months
10971558|NCT00915928|FG001|Participant Flow|Placebo|Placebo
10971559|NCT00915928|OG000|Outcome|ACE Inhibitor|Perindopril: 2,5 mg daily for 3 months
10971560|NCT00915928|OG001|Outcome|Placebo|Placebo
10971561|NCT00915928|OG000|Outcome|Composition of Chronic Subdural Hematoma Fluid|Biochemical analysis of CSDH fluid content. This analysis will not be performed due to insufficient funding
10971562|NCT00915928|EG000|Reported Event|ACE Inhibitor|Active compound
10971563|NCT00915928|EG001|Reported Event|Placebo|Inactive placebo
11298742|NCT03020082|FG000|Participant Flow|Danoprevir, Ritonavir, Peg-IFN,RBV|"Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.~Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;~Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks;~peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;~RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks."
11298743|NCT03020082|OG000|Outcome|Danoprevir, Ritonavir, Peg-IFN,RBV|"Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.~Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;~Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks;~peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;~RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks."
11298744|NCT03020082|EG000|Reported Event|Danoprevir, Ritonavir, Peg-IFN,RBV|"Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.~Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;~Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks;~peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;~RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks."
11298745|NCT03020095|BG000|Baseline|Ravidasvir,Danoprevir/r,RBV|"Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.~Ravidasvir: Ravidasvir 200mg tablet administered orally once daily~Danoprevir: Danoprevir 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally"
11298746|NCT03020095|FG000|Participant Flow|Ravidasvir,Danoprevir/r,RBV|"Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.~Ravidasvir: Ravidasvir 200mg tablet administered orally once daily~Danoprevir: Danoprevir 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally"
11298747|NCT03020095|OG000|Outcome|Ravidasvir,Danoprevir/r,RBV|"Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.~Ravidasvir: Ravidasvir 200mg tablet administered orally once daily~Danoprevir: Danoprevir 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally"
11298748|NCT03020095|EG000|Reported Event|Ravidasvir,Danoprevir/r,RBV|"Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.~Ravidasvir: Ravidasvir 200mg tablet administered orally once daily~Danoprevir: Danoprevir 100mg tablet administered orally twice daily~Ritonavir: Ritonavir 100mg tablet administered orally twice daily~Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally"
11298749|NCT03020407|BG000|Baseline|IVC Ultrasound-guided|"The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.~Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy."
11298750|NCT03020407|BG001|Baseline|Usual Care|Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
11298751|NCT03020407|BG002|Baseline|Total|Total of all reporting groups
11332842|NCT03502265|EG000|Reported Event|Otteroo Adjunct|"A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms.~Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided."
11332843|NCT03502616|BG000|Baseline|Tofacitinib|Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
11332844|NCT03502616|BG001|Baseline|Placebo Then Tofacitinib|Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
11332845|NCT03502616|BG002|Baseline|Total|Total of all reporting groups
11332846|NCT03502616|FG000|Participant Flow|Tofacitinib|Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
11298752|NCT03020407|FG000|Participant Flow|IVC Ultrasound-guided|"The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.~Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy."
11298753|NCT03020407|FG001|Participant Flow|Usual Care|Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
11298754|NCT03020407|OG000|Outcome|IVC Ultrasound-guided|"The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.~Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy."
11298755|NCT03020407|OG001|Outcome|Usual Care|Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
11298756|NCT03020407|EG000|Reported Event|IVC Ultrasound-guided|"The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.~Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.~Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy."
11298757|NCT03020407|EG001|Reported Event|Usual Care|Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
11298758|NCT03020472|BG000|Baseline|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
11298759|NCT03020472|FG000|Participant Flow|2008-2009 FluMist LAIV (Intranasal)|"Seasonal live, attenuated influenza vaccine (LAIV)~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
11298760|NCT03020472|OG000|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
11298761|NCT03020472|EG000|Reported Event|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
11298762|NCT03020498|BG000|Baseline|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298763|NCT03020498|BG001|Baseline|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
10971564|NCT00915954|BG000|Baseline|Active Acromegaly|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971565|NCT00915954|BG001|Baseline|Type 2 Diabetes Mellitus(DM)|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971566|NCT00915954|BG002|Baseline|Heathly Controls|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971567|NCT00915954|BG003|Baseline|Total|Total of all reporting groups
10971568|NCT00915954|FG000|Participant Flow|Active Acromegaly|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971569|NCT00915954|FG001|Participant Flow|Type 2 Diabetes Mellitus(DM)|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971570|NCT00915954|FG002|Participant Flow|Heathly Controls|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971571|NCT00915954|OG000|Outcome|Active Acromegaly|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971572|NCT00915954|OG001|Outcome|Type 2 Diabetes Mellitus(DM)|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971573|NCT00915954|OG002|Outcome|Heathly Controls|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971574|NCT00915954|EG000|Reported Event|Active Acromegaly|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
11298764|NCT03020498|BG002|Baseline|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11298765|NCT03020498|BG003|Baseline|Total|Total of all reporting groups
11298766|NCT03020498|FG000|Participant Flow|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298767|NCT03020498|FG001|Participant Flow|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298768|NCT03020498|FG002|Participant Flow|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11298769|NCT03020498|OG000|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298770|NCT03020498|OG001|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298771|NCT03020498|OG002|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11298772|NCT03020498|EG000|Reported Event|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298773|NCT03020498|EG001|Reported Event|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
11298774|NCT03020498|EG002|Reported Event|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11298775|NCT03020524|BG000|Baseline|Dose Level 1|Autologous CD4 T-Cells0.8-1x10^9 transduced CD4+T-cells administered IV as a single dose
11298776|NCT03020524|BG001|Baseline|Dose Level 2|Autologous CD4 T-Cells 2.4-3x10^9 transduced CD4+ T-cells administered IV as a single dose
11298777|NCT03020524|BG002|Baseline|Dose Level 3|Autologous CD4 T-Cells 0.8-1x10^10 transduced CD4+ T-cells administered IV as a single dose
11298778|NCT03020524|BG003|Baseline|Total|Total of all reporting groups
11298779|NCT03020524|FG000|Participant Flow|Dose Level 1|Autologous CD4 T-Cells0.8-1x10^9 transduced CD4+T-cells administered IV as a single dose
11298780|NCT03020524|FG001|Participant Flow|Dose Level 2|Autologous CD4 T-Cells 2.4-3x10^9 transduced CD4+ T-cells administered IV as a single dose
11298781|NCT03020524|FG002|Participant Flow|Dose Level 3|Autologous CD4 T-Cells 0.8-1x10^10 transduced CD4+ T-cells administered IV as a single dose
11298782|NCT03020524|OG000|Outcome|Dose Level 1|Autologous CD4 T-Cells0.8-1x10^9 transduced CD4+T-cells administered IV as a single dose
11298783|NCT03020524|OG001|Outcome|Dose Level 2|Autologous CD4 T-Cells 2.4-3x10^9 transduced CD4+ T-cells administered IV as a single dose
11298784|NCT03020524|OG002|Outcome|Dose Level 3|Autologous CD4 T-Cells 0.8-1x10^10 transduced CD4+ T-cells administered IV as a single dose
11298785|NCT03020524|EG000|Reported Event|Dose Level 1|Autologous CD4 T-Cells0.8-1x10^9 transduced CD4+T-cells administered IV as a single dose
11298786|NCT03020524|EG001|Reported Event|Dose Level 2|Autologous CD4 T-Cells 2.4-3x10^9 transduced CD4+ T-cells administered IV as a single dose
11298787|NCT03020524|EG002|Reported Event|Dose Level 3|Autologous CD4 T-Cells 0.8-1x10^10 transduced CD4+ T-cells administered IV as a single dose
11298788|NCT03020537|BG000|Baseline|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298789|NCT03020537|BG001|Baseline|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298790|NCT03020537|BG002|Baseline|Total|Total of all reporting groups
11298791|NCT03020537|FG000|Participant Flow|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298792|NCT03020537|FG001|Participant Flow|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11332847|NCT03502616|FG001|Participant Flow|Placebo Then Tofacitinib|Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
11298793|NCT03020537|OG000|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298794|NCT03020537|OG001|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
10971575|NCT00915954|EG001|Reported Event|Type 2 Diabetes Mellitus(DM)|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971576|NCT00915954|EG002|Reported Event|Heathly Controls|"Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.~Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.~Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.~Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws."
10971577|NCT00915967|BG000|Baseline|Vancomycin|"Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.~Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure."
10971578|NCT00915967|BG001|Baseline|Saline|"Subjects in the saline group will receive a Saline injection directly into the wound pocket.~Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure."
10971579|NCT00915967|BG002|Baseline|Total|Total of all reporting groups
10971580|NCT00915967|FG000|Participant Flow|Vancomycin|"Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.~Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure."
10971581|NCT00915967|FG001|Participant Flow|Saline|"Subjects in the saline group will receive a Saline injection directly into the wound pocket.~Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure."
10971582|NCT00915967|OG000|Outcome|Vancomycin|"Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.~Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure."
10971583|NCT00915967|OG001|Outcome|Saline|"Subjects in the saline group will receive a Saline injection directly into the wound pocket.~Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure."
11298795|NCT03020537|EG000|Reported Event|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298796|NCT03020537|EG001|Reported Event|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
11298797|NCT03020550|BG000|Baseline|Standard Visit|Patients with GERD receiving a standard medical visit
11298798|NCT03020550|BG001|Baseline|Expanded Visit|Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
11298799|NCT03020550|BG002|Baseline|Total|Total of all reporting groups
11298800|NCT03020550|FG000|Participant Flow|Standard Visit|A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.
10971584|NCT00915967|EG000|Reported Event|Vancomycin|"Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.~Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure."
10971585|NCT00915967|EG001|Reported Event|Saline|"Subjects in the saline group will receive a Saline injection directly into the wound pocket.~Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure."
10971586|NCT00916006|BG000|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971587|NCT00916006|BG001|Baseline|Vehicle|Vehicle gel once daily for 3 consecutive days
10971588|NCT00916006|BG002|Baseline|Total|Total of all reporting groups
11298801|NCT03020550|FG001|Participant Flow|Expanded Visit|"A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's constitutional type as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?)."
11298802|NCT03020550|OG000|Outcome|Standard Visit|Patients with GERD receiving a standard medical visit
10971589|NCT00916006|FG000|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971590|NCT00916006|FG001|Participant Flow|Vehicle|Vehicle gel once daily for 3 consecutive days
11298803|NCT03020550|OG001|Outcome|Expanded Visit|Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
11298804|NCT03020550|EG000|Reported Event|Standard Visit|Patients with GERD receiving a standard medical visit
11298805|NCT03020550|EG001|Reported Event|Expanded Visit|Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
11298806|NCT03020576|BG000|Baseline|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
11298807|NCT03020576|BG001|Baseline|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
11298808|NCT03020576|BG002|Baseline|Total|Total of all reporting groups
11298809|NCT03020576|FG000|Participant Flow|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
11298810|NCT03020576|FG001|Participant Flow|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
11298811|NCT03020576|OG000|Outcome|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
11298812|NCT03020576|OG001|Outcome|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
11298813|NCT03020576|EG000|Reported Event|Conventional Group|The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.
11298814|NCT03020576|EG001|Reported Event|Robotic Group|The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.
11298815|NCT03020615|BG000|Baseline|Stable Dosing|"In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 1 (Stable Dosing) continues standard treatment.~Hydroxyurea: Given orally once daily."
11298816|NCT03020615|BG001|Baseline|Intensive Dosing|"In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 2 (Intensive Dosing) will have their HU dose increased by 5 mg/kg/day every 8 weeks up to a maximum of 35 mg/kg/day.~Hydroxyurea: Given orally once daily."
10971591|NCT00916006|OG000|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
11298817|NCT03020615|BG002|Baseline|Non-Randomized Patients|Patients who came off study prior to randomization
11298818|NCT03020615|BG003|Baseline|Total|Total of all reporting groups
11298819|NCT03020615|FG000|Participant Flow|Stable Dosing|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 1 (Stable Dosing) continues standard treatment.
11298820|NCT03020615|FG001|Participant Flow|Intensive Dosing|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 2 (Intensive Dosing) will have their HU dose increased by 5 mg/kg/day every 8 weeks up to a maximum of 35 mg/kg/day.
10971592|NCT00916006|OG001|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
10971593|NCT00916006|EG000|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
10971594|NCT00916006|EG001|Reported Event|Vehicle|Vehicle gel once daily for 3 consecutive days
10971595|NCT00916032|BG000|Baseline|All Study Participants|Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.
11298821|NCT03020615|FG002|Participant Flow|Non-Randomized|Participants who came off study prior to randomization
11298822|NCT03020615|OG000|Outcome|All Participants|All Participants enrolled on study.
11298823|NCT03020615|OG000|Outcome|Stable Dosing|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 1 (Stable Dosing) continues standard treatment.
11298824|NCT03020615|OG001|Outcome|Intensive Dosing|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 2 (Intensive Dosing) will have their HU dose increased by 5 mg/kg/day every 8 weeks up to a maximum of 35 mg/kg/day.
11298825|NCT03020615|OG000|Outcome|Randomized Participants|Number of participants randomized.
11298826|NCT03020615|OG000|Outcome|Subjects Approached Who Declined Participation|Subjects who declined to participate in HUGKISS and provided reasons for declining
11298827|NCT03020615|OG002|Outcome|Overall|All subjects who completed protocol therapy
11298828|NCT03020615|EG000|Reported Event|Stable Dosing - Post Randomization|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 1 (Stable Dosing) continues standard treatment.
11298829|NCT03020615|EG001|Reported Event|Intensive Dosing - Post Randomization|In the first 8 weeks (± 2 weeks) of this study, participants will receive standard treatment [a fixed dose of 20 (± 2.5) mg/kg/day of hydroxyurea]. After 8 weeks (± 2 weeks) of standard treatment, participants will be randomized (like flipping a coin) to one of two treatment groups. Group 2 (Intensive Dosing) will have their HU dose increased by 5 mg/kg/day every 8 weeks up to a maximum of 35 mg/kg/day.
11298830|NCT03020615|EG002|Reported Event|All Participants - Pre Randomization|All participants enrolled
11298831|NCT03020641|BG000|Baseline|Experimental|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298832|NCT03020641|BG001|Baseline|Control|Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298833|NCT03020641|BG002|Baseline|Total|Total of all reporting groups
11298834|NCT03020641|FG000|Participant Flow|Control|Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298835|NCT03020641|FG001|Participant Flow|Intervention|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298836|NCT03020641|OG000|Outcome|Control|Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298837|NCT03020641|OG001|Outcome|Experimental|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298838|NCT03020641|OG000|Outcome|Intervention|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298839|NCT03020641|OG001|Outcome|Control|Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298840|NCT03020641|OG000|Outcome|Experimental|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298841|NCT03020641|EG000|Reported Event|Control|Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298842|NCT03020641|EG001|Reported Event|Experimental|Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
11298843|NCT03020719|BG000|Baseline|Oral Glutathione|"Oral Glutathione oral powder at 65mg/kg/day~Oral Glutathione: Oral Glutathione oral powder"
11298844|NCT03020719|BG001|Baseline|Placebo|"Placebo oral powder at 65mg/kg/day~Placebo: Placebo oral powder"
11298845|NCT03020719|BG002|Baseline|Total|Total of all reporting groups
11298846|NCT03020719|FG000|Participant Flow|Oral Glutathione|"Oral Glutathione oral powder at 65mg/kg/day~Oral Glutathione: Oral Glutathione oral powder"
11298847|NCT03020719|FG001|Participant Flow|Placebo|"Placebo oral powder at 65mg/kg/day~Placebo: Placebo oral powder"
11298848|NCT03020719|OG000|Outcome|Oral Glutathione|"Oral Glutathione oral powder at 65mg/kg/day~Oral Glutathione: Oral Glutathione oral powder"
11298849|NCT03020719|OG001|Outcome|Placebo|"Placebo oral powder at 65mg/kg/day~Placebo: Placebo oral powder"
11298850|NCT03020719|EG000|Reported Event|Oral Glutathione|"Oral Glutathione oral powder at 65mg/kg/day~Oral Glutathione: Oral Glutathione oral powder"
11298851|NCT03020719|EG001|Reported Event|Placebo|"Placebo oral powder at 65mg/kg/day~Placebo: Placebo oral powder"
11298852|NCT03020745|BG000|Baseline|Part 1: Placebo|Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
11298853|NCT03020745|BG001|Baseline|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
11298854|NCT03020745|BG002|Baseline|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
11298855|NCT03020745|BG003|Baseline|Part 2: Placebo|Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298856|NCT03020745|BG004|Baseline|Part 2: GSK3389404 30 mg Weekly|Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298857|NCT03020745|BG005|Baseline|Part 2: GSK3389404 60 mg Weekly|Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298858|NCT03020745|BG006|Baseline|Part 2: GSK3389404 120 mg Bi-weekly|Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298859|NCT03020745|BG007|Baseline|Part 2: GSK3389404 120 mg Weekly|Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298860|NCT03020745|BG008|Baseline|Total|Total of all reporting groups
11298861|NCT03020745|FG000|Participant Flow|Part 1: Placebo|Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
11298862|NCT03020745|FG001|Participant Flow|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
11298863|NCT03020745|FG002|Participant Flow|Part 1: GSK3389404 60 mg|Participants received a single dose of GSK3389404 60 mg via SC route on Day 1.
11298864|NCT03020745|FG003|Participant Flow|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
11298865|NCT03020745|FG004|Participant Flow|Part 1: GSK3389404 240 mg|Participants received a single dose of GSK3389404 240 mg via SC route on Day 1.
11298866|NCT03020745|FG005|Participant Flow|Part 2: Placebo|Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298867|NCT03020745|FG006|Participant Flow|Part 2: GSK3389404 30 mg Weekly|Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298868|NCT03020745|FG007|Participant Flow|Part 2: GSK3389404 60 mg Weekly|Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298869|NCT03020745|FG008|Participant Flow|Part 2: GSK3389404 120 mg Bi-weekly|Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298870|NCT03020745|FG009|Participant Flow|Part 2: GSK3389404 120 mg Weekly|Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298871|NCT03020745|OG000|Outcome|Part 1: Placebo|Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
11298872|NCT03020745|OG001|Outcome|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
11298873|NCT03020745|OG002|Outcome|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
11298874|NCT03020745|OG000|Outcome|Part 2: Placebo|Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298875|NCT03020745|OG001|Outcome|Part 2: GSK3389404 30 mg Weekly|Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298876|NCT03020745|OG002|Outcome|Part 2: GSK3389404 60 mg Weekly|Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298877|NCT03020745|OG003|Outcome|Part 2: GSK3389404 120 mg Bi-weekly|Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298878|NCT03020745|OG004|Outcome|Part 2: GSK3389404 120 mg Weekly|Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298879|NCT03020745|OG000|Outcome|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
11298880|NCT03020745|OG001|Outcome|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
11298881|NCT03020745|OG000|Outcome|Part 2: GSK3389404 30 mg Weekly|Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298882|NCT03020745|OG001|Outcome|Part 2: GSK3389404 60 mg Weekly|Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298883|NCT03020745|OG002|Outcome|Part 2: GSK3389404 120 mg Bi-weekly|Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298884|NCT03020745|OG003|Outcome|Part 2: GSK3389404 120 mg Weekly|Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298885|NCT03020745|EG000|Reported Event|Part 1: Placebo|Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
11298886|NCT03020745|EG001|Reported Event|Part 1: GSK3389404 30 mg|Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
11298887|NCT03020745|EG002|Reported Event|Part 1: GSK3389404 120 mg|Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
11298888|NCT03020745|EG003|Reported Event|Part 2: Placebo|Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298889|NCT03020745|EG004|Reported Event|Part 2: GSK3389404 30 mg Weekly|Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298890|NCT03020745|EG005|Reported Event|Part 2: GSK3389404 60 mg Weekly|Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298891|NCT03020745|EG006|Reported Event|Part 2: GSK3389404 120 mg Bi-weekly|Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11332848|NCT03502616|OG000|Outcome|Tofacitinib|Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.
10971596|NCT00916032|FG000|Participant Flow|Two 1500 IU Vials Then One 3000 IU Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
11298892|NCT03020745|EG007|Reported Event|Part 2: GSK3389404 120 mg Weekly|Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
11298893|NCT03020888|BG000|Baseline|Magseed and Sentimag|"Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.~Marker located during surgery using the Sentimag system, and removed with the lesion.~Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization"
11298894|NCT03020888|FG000|Participant Flow|Magseed and Sentimag|"Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.~Marker located during surgery using the Sentimag system, and removed with the lesion.~Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization"
11298895|NCT03020888|OG000|Outcome|Magseed and Sentimag|"Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.~Marker located during surgery using the Sentimag system, and removed with the lesion.~Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization"
11298896|NCT03020888|EG000|Reported Event|Magseed and Sentimag|"Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.~Marker located during surgery using the Sentimag system, and removed with the lesion.~Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization"
11298897|NCT03020966|BG000|Baseline|Oral Tylenol|"Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo~Acetaminophen: Oral acetaminophen, intravenous placebo"
11298898|NCT03020966|BG001|Baseline|Intravenous Tylenol|"Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo~Acetaminophen: Intravenous acetaminophen, oral placebo"
11298899|NCT03020966|BG002|Baseline|Total|Total of all reporting groups
11298900|NCT03020966|FG000|Participant Flow|Oral Tylenol|"Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo~Acetaminophen: Oral acetaminophen, intravenous placebo"
11298901|NCT03020966|FG001|Participant Flow|Intravenous Tylenol|"Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo~Acetaminophen: Intravenous acetaminophen, oral placebo"
11298902|NCT03020966|OG000|Outcome|Oral Tylenol|"Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo~Acetaminophen: Oral acetaminophen, intravenous placebo"
11298903|NCT03020966|OG001|Outcome|Intravenous Tylenol|"Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo~Acetaminophen: Intravenous acetaminophen, oral placebo"
11298904|NCT03020966|EG000|Reported Event|Oral Tylenol|"Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo~Acetaminophen: Oral acetaminophen, intravenous placebo"
11298905|NCT03020966|EG001|Reported Event|Intravenous Tylenol|"Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo~Acetaminophen: Intravenous acetaminophen, oral placebo"
11298906|NCT03020992|BG000|Baseline|Certolizumab Pegol|Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).
11298907|NCT03020992|FG000|Participant Flow|Certolizumab Pegol|Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).
11298908|NCT03020992|OG000|Outcome|Certolizumab Pegol (FAS)|Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).
11298909|NCT03020992|OG000|Outcome|Certolizumab Pegol (SS)|Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).
11298910|NCT03020992|EG000|Reported Event|Certolizumab Pegol (SS)|Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).
11298911|NCT03021005|BG000|Baseline|Experimental: Self Testing Kit|"This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the I Want The Kit website."
11298912|NCT03021005|BG001|Baseline|No Intervention: No Self Testing Kit|"This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the I Want The Kit website."
11298913|NCT03021005|BG002|Baseline|Total|Total of all reporting groups
11298914|NCT03021005|FG000|Participant Flow|Experimental: Self Testing Kit|"This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the I Want The Kit website."
11298915|NCT03021005|FG001|Participant Flow|No Intervention: No Self Testing Kit|"This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the I Want The Kit website."
11332849|NCT03502616|OG001|Outcome|Placebo Then Tofacitinib|Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
11332850|NCT03502616|EG000|Reported Event|Tofacitinib: Up to Week 16|Participants received tofacitinib 5 mg tablets twice daily for 16 weeks.
11298916|NCT03021005|OG000|Outcome|Self Testing Kit|"This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the I Want The Kit website.~HIV Self-testing"
11298917|NCT03021005|OG001|Outcome|No Self Testing Kit|"This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the I Want The Kit website."
11298918|NCT03021005|EG000|Reported Event|Experimental: Self Testing Kit|"This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the I Want The Kit website."
11298919|NCT03021005|EG001|Reported Event|No Intervention: No Self Testing Kit|"This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the I Want The Kit website."
11298920|NCT03021018|BG000|Baseline|Lorazepam (LZP)|Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.
11298921|NCT03021018|BG001|Baseline|Brivaracetam (BRV) 100 mg|Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.
11298922|NCT03021018|BG002|Baseline|Brivaracetam (BRV) 200 mg|Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.
11298923|NCT03021018|BG003|Baseline|Total Title|
11298924|NCT03021018|FG000|Participant Flow|Lorazepam (LZP)|Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.
11298925|NCT03021018|FG001|Participant Flow|Brivaracetam (BRV) 100 mg|Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.
11298926|NCT03021018|FG002|Participant Flow|Brivaracetam (BRV) 200 mg|Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.
11298927|NCT03021018|OG000|Outcome|Lorazepam (LZP) (ITT-R)|Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
11298928|NCT03021018|OG001|Outcome|Brivaracetam (BRV) 100 mg (ITT-R)|Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
11298929|NCT03021018|OG002|Outcome|Brivaracetam (BRV) 200 mg (ITT-R)|Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
11298930|NCT03021018|EG000|Reported Event|Lorazepam (LZP) (ITT-T)|Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Treated (ITT-T) Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
11298931|NCT03021018|EG001|Reported Event|Brivaracetam (BRV) 100 mg (ITT-T)|Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
11298932|NCT03021018|EG002|Reported Event|Brivaracetam (BRV) 200 mg (ITT-T)|Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
11298933|NCT03021187|BG000|Baseline|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.
11298934|NCT03021187|BG001|Baseline|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.
11298935|NCT03021187|BG002|Baseline|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.
11298936|NCT03021187|BG003|Baseline|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.
11298937|NCT03021187|BG004|Baseline|Total|Total of all reporting groups
11298938|NCT03021187|FG000|Participant Flow|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.
11298939|NCT03021187|FG001|Participant Flow|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.
11298940|NCT03021187|FG002|Participant Flow|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.
11298941|NCT03021187|FG003|Participant Flow|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.
11298942|NCT03021187|OG000|Outcome|Oral Semaglutide 3 mg|Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.
11298943|NCT03021187|OG001|Outcome|Oral Semaglutide 7 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.
11298944|NCT03021187|OG002|Outcome|Oral Semaglutide 14 mg|Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.
11298945|NCT03021187|OG003|Outcome|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.
11298946|NCT03021187|EG000|Reported Event|Oral Semaglutide 3 mg|Subjects were to take oral semaglutide 3 mg tablets once daily from week 1 to 52.
11298947|NCT03021187|EG001|Reported Event|Oral Semaglutide 7 mg|Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 52: 3 mg from week 1 to 4 and 7 mg from week 5 to 52.
11298948|NCT03021187|EG002|Reported Event|Oral Semaglutide 14 mg|Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 52: 3 mg from week 1 to 4, 7 mg from week 5 to 8 and 14 mg from week 9 to 52.
11298949|NCT03021187|EG003|Reported Event|Placebo|Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.
11298950|NCT03021265|BG000|Baseline|Micatrio® Combination Tablets|Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
11298951|NCT03021265|FG000|Participant Flow|Micatrio® Combination Tablets|Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
11298952|NCT03021265|OG000|Outcome|Micatrio® Combination Tablets|Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
11298953|NCT03021265|EG000|Reported Event|Micatrio|Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
11298954|NCT03021304|BG000|Baseline|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
11298955|NCT03021304|FG000|Participant Flow|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
11298956|NCT03021304|OG000|Outcome|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4 weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12 weeks.
11298957|NCT03021304|EG000|Reported Event|Mepolizumab Liquid Safety Syringe|The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
11298958|NCT03021343|BG000|Baseline|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
11298959|NCT03021343|BG001|Baseline|No Colchicine|In this arm no active medication was administered
11298960|NCT03021343|BG002|Baseline|Total|Total of all reporting groups
11298961|NCT03021343|FG000|Participant Flow|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
11298962|NCT03021343|FG001|Participant Flow|No Colchicine|In this arm no active medication was administered
11298963|NCT03021343|OG000|Outcome|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
11298964|NCT03021343|OG001|Outcome|No Colchicine|In this arm no active medication was administered
11298965|NCT03021343|EG000|Reported Event|Colchicine|"Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.~Colchicine: colchicine given as per trial protocol"
11298966|NCT03021343|EG001|Reported Event|No Colchicine|In this arm no active medication was administered
11298967|NCT03021499|BG000|Baseline|Voclosporin|"oral, 23.7 mg BID~Voclosporin: calcineurin inhibitor"
11298968|NCT03021499|BG001|Baseline|Placebo|"Voclosporin placebo, oral, 3 capsules BID~Placebo: matching placebo capsule"
11298969|NCT03021499|BG002|Baseline|Total|Total of all reporting groups
11298970|NCT03021499|FG000|Participant Flow|Voclosporin|Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298971|NCT03021499|FG001|Participant Flow|Placebo|Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298972|NCT03021499|OG000|Outcome|Voclosporin|"oral, 23.7 mg BID~Voclosporin: calcineurin inhibitor"
11298973|NCT03021499|OG001|Outcome|Placebo Oral Capsule|"Voclosporin placebo, oral, 3 capsules BID~Placebo Oral Capsule: matching placebo capsule"
11298974|NCT03021499|OG000|Outcome|Voclosporin|Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298975|NCT03021499|OG001|Outcome|Placebo Oral Capsule|Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298976|NCT03021499|EG000|Reported Event|Voclosporin|Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298977|NCT03021499|EG001|Reported Event|Placebo Oral Capsule|Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
11298978|NCT03021538|BG000|Baseline|Cardiopulmonary Bypass|"There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.~Cardiopulmonary Bypass: CPB is used during lung transplant procedure"
11298979|NCT03021538|BG001|Baseline|Extracorporeal Membrane Oxygenation|"There will be 40 patients randomized to ECMO during lung transplantation.~Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure"
11298980|NCT03021538|BG002|Baseline|Total|Total of all reporting groups
11332851|NCT03502616|EG001|Reported Event|Placebo: Up to Week 16|Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks.
11298981|NCT03021538|FG000|Participant Flow|Cardiopulmonary Bypass|"There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.~Cardiopulmonary Bypass: CPB is used during lung transplant procedure"
11298982|NCT03021538|FG001|Participant Flow|Extracorporeal Membrane Oxygenation|"There will be 40 patients placed on ECMO during lung transplantation.~Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure"
11298983|NCT03021538|OG000|Outcome|Cardiopulmonary Bypass|"There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.~Cardiopulmonary Bypass: CPB is used during lung transplant procedure"
11298984|NCT03021538|OG001|Outcome|Extracorporeal Membrane Oxygenation|"There will be 40 patients randomized to ECMO during lung transplantation.~Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure"
11298985|NCT03021538|EG000|Reported Event|Cardiopulmonary Bypass|"There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.~Cardiopulmonary Bypass: CPB is used during lung transplant procedure"
11298986|NCT03021538|EG001|Reported Event|Extracorporeal Membrane Oxygenation|"There will be 40 patients placed on ECMO during lung transplantation.~Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure"
11298987|NCT03021564|BG000|Baseline|Shockable Rhythms|Patients with documented shockable rhythms during cardiac arrest
11298988|NCT03021564|BG001|Baseline|Non-shockable Rhythms|Patients with documented non-shockable rhythms during cardiac arrest
11298989|NCT03021564|BG002|Baseline|Total|Total of all reporting groups
11298990|NCT03021564|FG000|Participant Flow|Shockable Rhythms|Patients with documented shockable rhythms during cardiac arrest
11298991|NCT03021564|FG001|Participant Flow|Non-shockable Rhythms|Patients with documented non-shockable rhythms during cardiac arrest
11298992|NCT03021564|OG000|Outcome|In-ICU Admissions|Patients admitted in 45 participating intensive care unit (ICU) over one year
11298993|NCT03021564|OG000|Outcome|Shockable Rhythms|Patients with documented shockable rhythms during cardiac arrest
11298994|NCT03021564|OG001|Outcome|Non-shockable Rhythms|Patients with documented non-shockable rhythms during cardiac arrest
11298995|NCT03021564|OG000|Outcome|Shockable Rhythms and Alive at Hospital Discharge|Patients with documented shockable rhythms during cardiac arrest and alive at hospital discharge
11298996|NCT03021564|OG001|Outcome|Non-shockable Rhythms and Alive at Hospital Discharge|Patients with documented non-shockable rhythms during cardiac arrest and alive at hospital discharge
11298997|NCT03021564|OG000|Outcome|Shockable Rhythms and Alive at 6-month Follow-up|Patients with documented shockable rhythms during cardiac arrest and alive at 6-month follow-up
11298998|NCT03021564|OG001|Outcome|Non-shockable Rhythms and Alive at 6-month Follow-up|Patients with documented non-shockable rhythms during cardiac arrest and alive at 6-month follow-up
11298999|NCT03021564|EG000|Reported Event|In-ICU Admissions|Patients admitted in 45 participating intensive care unit (ICU) over one year
11299000|NCT03021642|BG000|Baseline|Entire Study Population|All subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1*500 mg) or a single oral dose of reference treatment of film-coated tepotinib tablet (5*100 mg tablet) in either Treatment Period 1 or 2.
11299001|NCT03021642|FG000|Participant Flow|First Tepotinib Test, Then Tepotinib Reference|Subjects received a single oral dose of test treatment of film-coated tepotinib tablet (1*500 milligram [mg]) in Treatment period 1 (Day 1) followed by a single oral dose of reference treatment of film-coated tepotinib tablet (5*100 mg tablet) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
11299002|NCT03021642|FG001|Participant Flow|First Tepotinib Reference, Then Tepotinib Test|Subjects received a single oral dose of reference treatment of film-coated tepotinib tablet (5*100 mg tablet) in Treatment period 1 (Day 1) followed by a single oral dose of test treatment of film-coated tepotinib tablet (1*500 mg) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
11299003|NCT03021642|OG000|Outcome|Tepotinib Test Treatment|Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1*500 mg tablet) in either Treatment period 1 or 2.
11299004|NCT03021642|OG001|Outcome|Tepotinib Reference Treatment|Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5*100 mg tablet) in either Treatment period 1 or 2.
11299005|NCT03021642|EG000|Reported Event|Tepotinib Test Treatment|Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1*500 mg tablet) in either Treatment period 1 or 2.
11299006|NCT03021642|EG001|Reported Event|Tepotinib Reference Treatment|Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5*100 mg tablet) in either Treatment period 1 or 2.
11299007|NCT03021668|BG000|Baseline|Prevena Peel & Place Dressing for Wound Closure|"In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.~Prevena Peel & Place Dressing: Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound"
11299008|NCT03021668|BG001|Baseline|Standard Closure of the Wound|"In the participants randomized to this arm the surgical site will be closed using the standard closure technique.~Standard Closure of the Surgical Incision: This would involve standard closure of the incision site"
11299009|NCT03021668|BG002|Baseline|Total|Total of all reporting groups
11299010|NCT03021668|FG000|Participant Flow|Prevena Peel & Place Dressing for Wound Closure|"In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.~Prevena Peel & Place Dressing: Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound"
11332852|NCT03502616|EG002|Reported Event|Tofacitinib: Day 1 to Week 48|Participants received tofacitinib 5 mg tablets twice daily for 48 weeks.
11299011|NCT03021668|FG001|Participant Flow|Standard Closure of the Wound|"In the participants randomized to this arm the surgical site will be closed using the standard closure technique.~Standard Closure of the Surgical Incision: This would involve standard closure of the incision site"
11299012|NCT03021668|OG000|Outcome|Prevena Peel & Place Dressing for Wound Closure|"In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.~Prevena Peel & Place Dressing: Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound"
11299013|NCT03021668|OG001|Outcome|Standard Closure of the Wound|"In the participants randomized to this arm the surgical site will be closed using the standard closure technique.~Standard Closure of the Surgical Incision: This would involve standard closure of the incision site"
11299014|NCT03021668|EG000|Reported Event|Prevena Peel & Place Dressing for Wound Closure|"In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.~Prevena Peel & Place Dressing: Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound"
11299015|NCT03021668|EG001|Reported Event|Standard Closure of the Wound|"In the participants randomized to this arm the surgical site will be closed using the standard closure technique.~Standard Closure of the Surgical Incision: This would involve standard closure of the incision site"
11299016|NCT03021759|BG000|Baseline|Control|No intervention
11299017|NCT03021759|BG001|Baseline|Active Choice|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin"
11299018|NCT03021759|BG002|Baseline|Active Choice With Social Comparison Feedback|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin~Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers"
11299019|NCT03021759|BG003|Baseline|Total|Total of all reporting groups
11299020|NCT03021759|FG000|Participant Flow|Control|No intervention
11299021|NCT03021759|FG001|Participant Flow|Active Choice|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin"
11299022|NCT03021759|FG002|Participant Flow|Active Choice With Social Comparison Feedback|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin.~Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers"
11299023|NCT03021759|OG000|Outcome|Control|No intervention
11299024|NCT03021759|OG001|Outcome|Active Choice|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin"
11299025|NCT03021759|OG002|Outcome|Active Choice With Social Comparison Feedback|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin~Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers"
11299026|NCT03021759|EG000|Reported Event|Control|No intervention
11299027|NCT03021759|EG001|Reported Event|Active Choice|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin"
11299028|NCT03021759|EG002|Reported Event|Active Choice With Social Comparison Feedback|"Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers~Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin~Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers"
11299029|NCT03022045|BG000|Baseline|Risankizumab 75 mg|Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299030|NCT03022045|BG001|Baseline|Risankizumab 150 mg|Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299031|NCT03022045|BG002|Baseline|Total|Total of all reporting groups
11299032|NCT03022045|FG000|Participant Flow|Risankizumab 75 mg|Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299033|NCT03022045|FG001|Participant Flow|Risankizumab 150 mg|Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299034|NCT03022045|OG000|Outcome|GPP Risankizumab 75 mg|Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299035|NCT03022045|OG001|Outcome|GPP Risankizumab 150 mg|Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299036|NCT03022045|OG000|Outcome|EP Risankizumab 75 mg|Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299037|NCT03022045|OG001|Outcome|EP Risankizumab 150 mg|Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299038|NCT03022045|EG000|Reported Event|GPP Risankizumab 75 mg|Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299039|NCT03022045|EG001|Reported Event|GPP Risankizumab 150 mg|Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299040|NCT03022045|EG002|Reported Event|EP Risankizumab 75 mg|Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299041|NCT03022045|EG003|Reported Event|EP Risankizumab 150 mg|Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
11299042|NCT03022084|BG000|Baseline|Desyncra|"This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.~Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System."
11299043|NCT03022084|BG001|Baseline|Cognitive Behavioral Therapy|"Standard of Care~Cognitive Behavioral Therapy: Standard of Care"
11299044|NCT03022084|BG002|Baseline|Total|Total of all reporting groups
11299045|NCT03022084|FG000|Participant Flow|Desyncra|"This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.~Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System."
11299046|NCT03022084|FG001|Participant Flow|Cognitive Behavioral Therapy|"Standard of Care~Cognitive Behavioral Therapy: Standard of Care"
11299047|NCT03022084|OG000|Outcome|Desyncra|"This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.~Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System."
11299048|NCT03022084|OG001|Outcome|Cognitive Behavioral Therapy|"Standard of Care~Cognitive Behavioral Therapy: Standard of Care"
11299049|NCT03022084|EG000|Reported Event|Desyncra|"This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.~Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System."
11299050|NCT03022084|EG001|Reported Event|Cognitive Behavioral Therapy|"Standard of Care~Cognitive Behavioral Therapy: Standard of Care"
11299051|NCT03022370|BG000|Baseline|Women - Intervention|Women who received the Stepping Stones and Creating Futures intervention
11299052|NCT03022370|BG001|Baseline|Men - Intervention|Men who received the intervention
11299053|NCT03022370|BG002|Baseline|Women - Control|Women in the wait list control
11299054|NCT03022370|BG003|Baseline|Men - Control|Men in the wait list control
11299055|NCT03022370|BG004|Baseline|Total|Total of all reporting groups
11299056|NCT03022370|FG000|Participant Flow|Stepping Stones and Creating Futures|Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.
11299057|NCT03022370|FG001|Participant Flow|Wait-list Control|Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.
11299058|NCT03022370|OG000|Outcome|Women - Intervention|Women who received the Stepping Stones and Creating Futures intervention
11299059|NCT03022370|OG001|Outcome|Men - Intervention|Men who received the intervention
11299060|NCT03022370|OG002|Outcome|Women - Control|Women in the wait list control
11299061|NCT03022370|OG003|Outcome|Men - Control|Men in the wait list control
11299062|NCT03022370|EG000|Reported Event|Women - Intervention|Women who received the Stepping Stones and Creating Futures intervention
11299063|NCT03022370|EG001|Reported Event|Men - Intervention|Men who received the intervention
11299064|NCT03022370|EG002|Reported Event|Women - Control|Women in the wait list control
11299065|NCT03022370|EG003|Reported Event|Men - Control|Men in the wait list control
11299066|NCT03022396|BG000|Baseline|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299067|NCT03022396|BG001|Baseline|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299068|NCT03022396|BG002|Baseline|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299069|NCT03022396|BG003|Baseline|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299070|NCT03022396|BG004|Baseline|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299071|NCT03022396|BG005|Baseline|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299072|NCT03022396|BG006|Baseline|Total|Total of all reporting groups
11299073|NCT03022396|FG000|Participant Flow|Group A: Age 8-17 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299074|NCT03022396|FG001|Participant Flow|Group B: Age 18-30 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299075|NCT03022396|FG002|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299076|NCT03022396|FG003|Participant Flow|Group D: Age 40 - 59 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299077|NCT03022396|FG004|Participant Flow|Group E: Age 40 - 59 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299078|NCT03022396|FG005|Participant Flow|Group F: Age 70 - 100 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299079|NCT03022396|OG000|Outcome|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299080|NCT03022396|OG001|Outcome|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299081|NCT03022396|OG002|Outcome|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299082|NCT03022396|OG003|Outcome|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299083|NCT03022396|OG004|Outcome|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299084|NCT03022396|OG005|Outcome|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)~High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299085|NCT03022396|EG000|Reported Event|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299086|NCT03022396|EG001|Reported Event|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299087|NCT03022396|EG002|Reported Event|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299088|NCT03022396|EG003|Reported Event|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299089|NCT03022396|EG004|Reported Event|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299090|NCT03022396|EG005|Reported Event|Group F: Age 70 - 100 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular) or High-Dose Fluzone® (intramuscular)~High-Dose Fluzone® (intramuscular): Licensed seasonal High-Dose trivalent inactivated influenza~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
11299091|NCT03022422|BG000|Baseline|Group B: 18-30 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299092|NCT03022422|BG001|Baseline|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299093|NCT03022422|BG002|Baseline|Group D: 40-64 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299094|NCT03022422|BG003|Baseline|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299095|NCT03022422|BG004|Baseline|Group F: 65-100 yo Identical Twins (TIV)|Individual twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
11299096|NCT03022422|BG005|Baseline|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual twins will receive Fluzone® high-dose TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
11299097|NCT03022422|BG006|Baseline|Total|Total of all reporting groups
11299098|NCT03022422|FG000|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299099|NCT03022422|FG001|Participant Flow|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299100|NCT03022422|FG002|Participant Flow|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299101|NCT03022422|FG003|Participant Flow|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299102|NCT03022422|FG004|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
11299103|NCT03022422|FG005|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
11299104|NCT03022422|OG000|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299105|NCT03022422|OG001|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299106|NCT03022422|OG002|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299107|NCT03022422|OG003|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299108|NCT03022422|OG004|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
11299109|NCT03022422|OG005|Outcome|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
11299110|NCT03022422|OG004|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
11299111|NCT03022422|OG005|Outcome|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
11299112|NCT03022422|EG000|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299113|NCT03022422|EG001|Reported Event|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299114|NCT03022422|EG002|Reported Event|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299115|NCT03022422|EG003|Reported Event|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299116|NCT03022422|EG004|Reported Event|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
11299117|NCT03022422|EG005|Reported Event|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
11299118|NCT03022435|BG000|Baseline|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
11299119|NCT03022435|BG001|Baseline|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299120|NCT03022435|BG002|Baseline|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299121|NCT03022435|BG003|Baseline|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299122|NCT03022435|BG004|Baseline|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
11299123|NCT03022435|BG005|Baseline|Total|Total of all reporting groups
11299124|NCT03022435|FG000|Participant Flow|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
11299125|NCT03022435|FG001|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299126|NCT03022435|FG002|Participant Flow|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
11299127|NCT03022435|FG003|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
10848365|NCT00289744|EG002|Reported Event|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
11299128|NCT03022435|FG004|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
11299129|NCT03022435|OG000|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
11299130|NCT03022435|OG001|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299131|NCT03022435|OG002|Outcome|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299132|NCT03022435|OG003|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299133|NCT03022435|OG004|Outcome|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
11299134|NCT03022435|OG000|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray
11299135|NCT03022435|OG002|Outcome|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
11299136|NCT03022435|OG004|Outcome|Group F: 65 - 100 yo Identical Twins (High Dose TIV)|Participants to receive High-Dose Fluzone® standardTIV
11299137|NCT03022435|EG000|Reported Event|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
11299138|NCT03022435|EG001|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299139|NCT03022435|EG002|Reported Event|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299140|NCT03022435|EG003|Reported Event|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
11299141|NCT03022435|EG004|Reported Event|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
11299142|NCT03022526|BG000|Baseline|Combined Spinal Epidural (CSE)|"intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~CSE~Bupivacaine / fentaNYL"
11299143|NCT03022526|BG001|Baseline|Epidural|"epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~Epidural~Bupivacaine / fentaNYL"
11299144|NCT03022526|BG002|Baseline|Total|Total of all reporting groups
11299145|NCT03022526|FG000|Participant Flow|Combined Spinal Epidural (CSE)|"intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~CSE~Bupivacaine / fentaNYL"
11299146|NCT03022526|FG001|Participant Flow|Epidural|"epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~Epidural~Bupivacaine / fentaNYL"
11299147|NCT03022526|OG000|Outcome|Combined Spinal Epidural (CSE)|"intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~CSE~Bupivacaine / fentaNYL"
11299148|NCT03022526|OG001|Outcome|Epidural|"epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~Epidural~Bupivacaine / fentaNYL"
11299149|NCT03022526|EG000|Reported Event|Combined Spinal Epidural (CSE)|"intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~CSE~Bupivacaine / fentaNYL"
11299150|NCT03022526|EG001|Reported Event|Epidural|"epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL~Epidural~Bupivacaine / fentaNYL"
11299151|NCT03022617|BG000|Baseline|Study Group|"Open-label drug administration group. No comparator.~Apremilast"
11299152|NCT03022617|FG000|Participant Flow|Study Group|"Open-label drug administration group. No comparator.~Apremilast"
11299153|NCT03022617|OG000|Outcome|Study Group|"Open-label drug administration group. No comparator.~Apremilast"
11299154|NCT03022617|EG000|Reported Event|Study Group|"Open-label drug administration group. No comparator.~Apremilast"
11299155|NCT03022630|BG000|Baseline|Comprehensive Palliative Care Services|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299156|NCT03022630|BG001|Baseline|Usual Hepatic Care|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11299157|NCT03022630|BG002|Baseline|Total|Total of all reporting groups
11299158|NCT03022630|FG000|Participant Flow|Comprehensive Palliative Care Services|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299159|NCT03022630|FG001|Participant Flow|Usual Hepatic Care|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11299160|NCT03022630|OG000|Outcome|Comprehensive Palliative Care Services|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299161|NCT03022630|OG001|Outcome|Usual Hepatic Care|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11332853|NCT03502616|EG003|Reported Event|Placebo Then Tofacitinib: Day 1 to Week 48|Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
11299162|NCT03022630|OG000|Outcome|Comprehensive Palliative Care Services - Caregivers|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299163|NCT03022630|OG001|Outcome|Usual Hepatic Care - Caregivers|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11299164|NCT03022630|OG000|Outcome|Comprehensive Palliative Care Service - Caregivers|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299165|NCT03022630|OG000|Outcome|Comprehensive Palliative Care Services - Providers|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299166|NCT03022630|OG001|Outcome|Usual Hepatic Care - Providers|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11299167|NCT03022630|EG000|Reported Event|Comprehensive Palliative Care Services|"Comprehensive Palliative Care services in addition to usual hepatic care~Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart."
11299168|NCT03022630|EG001|Reported Event|Usual Hepatic Care|"Usual hepatic care~Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations."
11299169|NCT03022799|BG000|Baseline|KM-819 - 10 mg (Part A)|6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299170|NCT03022799|BG001|Baseline|KM-819 - 30 mg (Part A)|6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299171|NCT03022799|BG002|Baseline|KM-819 - 100mg (Part A)|6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299172|NCT03022799|BG003|Baseline|KM-819 200mg (Part A)|6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299173|NCT03022799|BG004|Baseline|KM-819 - 400mg (Part A)|6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299174|NCT03022799|BG005|Baseline|KM-819 200mg (Elderly Male Subjects) (Part A)|6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299175|NCT03022799|BG006|Baseline|Placebo (Part A)|12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299176|NCT03022799|BG007|Baseline|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11332854|NCT03502681|BG000|Baseline|Dose Level 0: Starting Cohort|Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
11332855|NCT03502681|BG001|Baseline|Dose Level 1|Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
11299177|NCT03022799|BG008|Baseline|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299178|NCT03022799|BG009|Baseline|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299179|NCT03022799|BG010|Baseline|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299180|NCT03022799|BG011|Baseline|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299181|NCT03022799|BG012|Baseline|Placebo (Part B)|10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299182|NCT03022799|BG013|Baseline|Total|Total of all reporting groups
11299183|NCT03022799|FG000|Participant Flow|KM-819 - 10 mg (Part A)|6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299184|NCT03022799|FG001|Participant Flow|KM-819 - 30 mg (Part A)|6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299185|NCT03022799|FG002|Participant Flow|KM-819 - 100mg (Part A)|6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299186|NCT03022799|FG003|Participant Flow|KM-819 200mg (Part A)|6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299187|NCT03022799|FG004|Participant Flow|KM-819 - 400mg (Part A)|6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299188|NCT03022799|FG005|Participant Flow|KM-819 200mg (Elderly Male Subjects) (Part A)|6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299189|NCT03022799|FG006|Participant Flow|Placebo (Part A)|12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299190|NCT03022799|FG007|Participant Flow|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299191|NCT03022799|FG008|Participant Flow|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299192|NCT03022799|FG009|Participant Flow|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299193|NCT03022799|FG010|Participant Flow|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299194|NCT03022799|FG011|Participant Flow|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299195|NCT03022799|FG012|Participant Flow|Placebo (Part B)|10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299196|NCT03022799|OG000|Outcome|KM-819 - 10 mg (Part A)|6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299197|NCT03022799|OG001|Outcome|KM-819 - 30 mg (Part A)|6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299198|NCT03022799|OG002|Outcome|KM-819 - 100mg (Part A)|6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299199|NCT03022799|OG003|Outcome|KM-819 200mg (Part A)|6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299200|NCT03022799|OG004|Outcome|KM-819 - 400mg (Part A)|6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299201|NCT03022799|OG005|Outcome|KM-819 200mg (Elderly Male Subjects) (Part A)|6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299202|NCT03022799|OG006|Outcome|Placebo (Part A)|12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299203|NCT03022799|OG007|Outcome|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299204|NCT03022799|OG008|Outcome|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11332856|NCT03502681|BG002|Baseline|Total|Total of all reporting groups
11299205|NCT03022799|OG009|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
11299206|NCT03022799|OG010|Outcome|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299207|NCT03022799|OG011|Outcome|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299208|NCT03022799|OG012|Outcome|Placebo (Part B)|10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299209|NCT03022799|OG006|Outcome|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299210|NCT03022799|OG007|Outcome|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299211|NCT03022799|OG008|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299212|NCT03022799|OG009|Outcome|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299213|NCT03022799|OG010|Outcome|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299214|NCT03022799|OG000|Outcome|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299215|NCT03022799|OG001|Outcome|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299216|NCT03022799|OG002|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299217|NCT03022799|OG003|Outcome|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299218|NCT03022799|OG004|Outcome|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299219|NCT03022799|OG009|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299220|NCT03022799|OG002|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
11299221|NCT03022799|OG005|Outcome|Placebo (Part B)|10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299222|NCT03022799|OG000|Outcome|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299223|NCT03022799|OG001|Outcome|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours
11299224|NCT03022799|OG002|Outcome|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299225|NCT03022799|OG003|Outcome|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299226|NCT03022799|EG000|Reported Event|Placebo (Part A)|12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299227|NCT03022799|EG001|Reported Event|KM-819 - 10 mg (Part A)|6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299228|NCT03022799|EG002|Reported Event|KM-819 - 30 mg (Part A)|6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299229|NCT03022799|EG003|Reported Event|KM-819 - 100mg (Part A)|6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299230|NCT03022799|EG004|Reported Event|KM-819 200mg (Part A)|6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299231|NCT03022799|EG005|Reported Event|KM-819 - 400mg (Part A)|6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299232|NCT03022799|EG006|Reported Event|KM-819 200mg (Elderly Male Subjects) (Part A)|6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299233|NCT03022799|EG007|Reported Event|Placebo (Part B)|10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299234|NCT03022799|EG008|Reported Event|KM-819 30 mg (Part B)|6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299235|NCT03022799|EG009|Reported Event|KM-819 100 mg (Part B)|6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299236|NCT03022799|EG010|Reported Event|KM-819 200mg (Part B)|6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299237|NCT03022799|EG011|Reported Event|KM-819 400mg (Part B)|6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
11299238|NCT03022799|EG012|Reported Event|KM-819 200mg (Elderly Male Subjects) (Part B)|6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.
10848366|NCT00289757|BG000|Baseline|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
11299239|NCT03022916|BG000|Baseline|Jublia|"Both big toes will receive application of toenail polish. One big toe will not use Jublia.~Jublia: Application of Jublia to one big toenail~Nail polish: Application of nail polish to both big toe nails~Subjects had to be healthy and have a big toenail"
11299240|NCT03022916|FG000|Participant Flow|Efinaconazole Solution and Nail Polish|Efinaconazole Solution and Nail Polish only (no base coat and no top coat) applied to great toenail
11299241|NCT03022916|FG001|Participant Flow|Nail Polish Only|No efinaconazole applied to one great toe. Only Nail per treatment arm
11299242|NCT03022916|FG002|Participant Flow|Efinaconazole Solution, Nail Polish, Top Coat, and Base Coat|One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
11299243|NCT03022916|FG003|Participant Flow|Nail Polish + Top Coat + Efinaconazole Solution|One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
11299244|NCT03022916|OG000|Outcome|Nail Polish and Efinaconazole Solution|Nail polish and Efinaconazole solution application (daily application of Efinaconazole solution)
11299245|NCT03022916|OG001|Outcome|Efinaconazole Solution, Nail Polish, and Top Coat|Efinaconazole solution applied daily to nail with top coat and nail polish
11299246|NCT03022916|OG002|Outcome|Placebo Comparator: Nail Polish Only|Both big toes will use nail polish only
11299247|NCT03022916|OG003|Outcome|Base Coat + Nail Polish + Top Coat + Efinaconazole Solution|Active Comparator: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
11299248|NCT03022916|EG000|Reported Event|Jublia|"Both big toes will receive application of nail polish. . Only one big toe will use efinaconazole.~Jublia: Application of Jublia to one big toes~Nail polish: Application of nail polish to both big toe nails~Subjects had to be healthy and have a big toenail"
11299249|NCT03022981|BG000|Baseline|12 to < 18 Years Old|"PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks."
11299250|NCT03022981|BG001|Baseline|6 to < 12 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks."
11299251|NCT03022981|BG002|Baseline|3 to < 6 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed < 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed < 17 kg."
10848367|NCT00289757|FG000|Participant Flow|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
11299252|NCT03022981|BG003|Baseline|Total|Total of all reporting groups
11299253|NCT03022981|FG000|Participant Flow|12 to < 18 Years Old|"Pharmacokinetic (PK) Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks."
11299254|NCT03022981|FG001|Participant Flow|6 to < 12 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks."
11299255|NCT03022981|FG002|Participant Flow|3 to < 6 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed < 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed < 17 kg."
11299256|NCT03022981|OG000|Outcome|12 to < 18 Years Old|PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days.
11299257|NCT03022981|OG001|Outcome|6 to < 12 Years Old|PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.
11299258|NCT03022981|OG002|Outcome|3 to < 6 Years Old|PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed < 17 kg.
11299259|NCT03022981|OG000|Outcome|12 to < 18 Years Old|PK Lead-in Phase: SOF/VEL FDC 400/100 mg tablets once daily for 7 days.
11299260|NCT03022981|OG002|Outcome|Cohort 3 (3 to < 6 Years Old)|PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed < 17 kg.
11299261|NCT03022981|OG000|Outcome|12 to < 18 Years Old|Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.
11299262|NCT03022981|OG001|Outcome|6 to < 12 Years Old|Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.
11299263|NCT03022981|OG002|Outcome|3 to < 6 Years Old|Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed < 17 kg.
11299264|NCT03022981|OG001|Outcome|12 to <18 Years Old|Treatment Phase: 2 * SOF/VEL 200/50 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.
11299265|NCT03022981|OG002|Outcome|6 to < 12 Years Old|Treatment Phase: SOF/VEL FDC 200/50 mg tablets once daily for 12 weeks.
11299266|NCT03022981|OG003|Outcome|6 to <12 Years Old|Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks.
11299267|NCT03022981|OG004|Outcome|3 to < 6 Years Old|Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg.
11299268|NCT03022981|OG005|Outcome|3 to <6 Years Old|SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed < 17 kg.
11299269|NCT03022981|EG000|Reported Event|12 to < 18 Years Old|"PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks."
11299270|NCT03022981|EG001|Reported Event|6 to < 12 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks."
11299271|NCT03022981|EG002|Reported Event|3 to < 6 Years Old|"PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed < 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.~Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed < 17 kg."
11332857|NCT03502681|FG000|Participant Flow|Dose Level 0: Starting Cohort|Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
11332858|NCT03502681|FG001|Participant Flow|Dose Level 1|Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
11332859|NCT03502681|OG000|Outcome|Dose Level 0: Starting Cohort|Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
11332860|NCT03502681|OG001|Outcome|Dose Level 1|Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
11332861|NCT03502681|EG000|Reported Event|All Subjects|All subjects (6) from each dose level.
11332862|NCT03502798|BG000|Baseline|Scanning a/LCI (Pilot)|"Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.~The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements."
11299272|NCT03023137|BG000|Baseline|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
11299273|NCT03023137|BG001|Baseline|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
11299274|NCT03023137|BG002|Baseline|Total|Total of all reporting groups
11299275|NCT03023137|FG000|Participant Flow|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
11299276|NCT03023137|FG001|Participant Flow|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
11299277|NCT03023137|OG000|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
11299278|NCT03023137|OG001|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
11299279|NCT03023137|OG000|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
11299280|NCT03023137|EG000|Reported Event|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
11299281|NCT03023137|EG001|Reported Event|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
11299282|NCT03023176|BG000|Baseline|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
11299283|NCT03023176|FG000|Participant Flow|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
10848368|NCT00289757|OG000|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
11299284|NCT03023176|OG000|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
11299285|NCT03023176|EG000|Reported Event|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
11299286|NCT03023397|BG000|Baseline|Non-smokers|Non-smoking adults with a history of dust mite allergy and allergic rhinitis
10848369|NCT00289757|EG000|Reported Event|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
11299287|NCT03023397|BG001|Baseline|Cigarette Smokers|Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
11299288|NCT03023397|BG002|Baseline|E-cig Users|E-cig using adults with a history of dust mite allergy and allergic rhinitis
11299289|NCT03023397|BG003|Baseline|Total|Total of all reporting groups
11299290|NCT03023397|FG000|Participant Flow|Non-smokers|Non-smoking adults with a history of dust mite allergy and allergic rhinitis
11299291|NCT03023397|FG001|Participant Flow|Cigarette Smokers|Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
11299292|NCT03023397|FG002|Participant Flow|E-cig Users|E-cig using adults with a history of dust mite allergy and allergic rhinitis
11299293|NCT03023397|OG000|Outcome|Non-smokers|Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
11299294|NCT03023397|OG001|Outcome|Cigarette Smokers|Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
11299295|NCT03023397|OG002|Outcome|E-cig Users|Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
11299296|NCT03023397|OG000|Outcome|Non-smokers|Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
11299297|NCT03023397|EG000|Reported Event|Non-smoker|Non-smoking adults with a history of dust mite allergy and allergic rhinitis
11299298|NCT03023397|EG001|Reported Event|Cigarette Smoker|Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
11299299|NCT03023397|EG002|Reported Event|E-cig User|E-cig using adults with a history of dust mite allergy and allergic rhinitis
11299300|NCT03023423|BG000|Baseline|Safety Run-in Phase: Daratumumab + Atezolizumab|Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299301|NCT03023423|BG001|Baseline|Randomized Phase: Atezolizumab|Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299302|NCT03023423|BG002|Baseline|Randomized Phase: Daratumumab + Atezolizumab|Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299303|NCT03023423|BG003|Baseline|Total|Total of all reporting groups
11299304|NCT03023423|FG000|Participant Flow|Safety Run-in Phase: Daratumumab + Atezolizumab|Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299305|NCT03023423|FG001|Participant Flow|Randomized Phase: Atezolizumab|Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299306|NCT03023423|FG002|Participant Flow|Randomized Phase: Daratumumab + Atezolizumab|Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299307|NCT03023423|OG000|Outcome|Randomized Phase: Atezolizumab|Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299308|NCT03023423|OG001|Outcome|Randomized Phase: Daratumumab + Atezolizumab|Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299309|NCT03023423|OG000|Outcome|Safety Run-in: Atezolizumab + Daratumumab|Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter.
11299310|NCT03023423|OG001|Outcome|Randomized Phase: Atezolizumab|Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299311|NCT03023423|OG002|Outcome|Randomized Phase: Daratumumab + Atezolizumab|Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299312|NCT03023423|OG003|Outcome|Randomized Phase: Atezo Crossed Over to Dara + Atezo|Participants who crossed over from Atezolizumab arm (Randomized Phase) to Daratumumab + Atezolizumab arm (Randomized Phase) received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol defined treatment discontinuation criteria.
11299313|NCT03023423|EG000|Reported Event|Safety Run-in Phase: Daratumumab + Atezolizumab|Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299314|NCT03023423|EG001|Reported Event|Randomized Phase: Atezolizumab|Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299315|NCT03023423|EG002|Reported Event|Randomized Phase: Daratumumab + Atezolizumab|Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
11299316|NCT03023423|EG003|Reported Event|Randomized Phase: Atezo Crossed Over to Dara + Atezo|Participants who crossed over from Atezolizumab arm (Randomized Phase) to Daratumumab + Atezolizumab arm (Randomized Phase) received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria.
10848370|NCT00289770|BG000|Baseline|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
11299317|NCT03023488|BG000|Baseline|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299318|NCT03023488|FG000|Participant Flow|Flexible Ureteroscopy Arm|"Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299319|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11335796|NCT03557034|OG000|Outcome|Standard of Care Monitoring|"Standard of Care~This is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."
11299320|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299321|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"The type of the ureteroscope used for the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299322|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"The duration of the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299323|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"The pressure applied to the irrigation solution during a flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299324|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"The number of patients that had a complication intraoperatively.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299325|NCT03023488|OG000|Outcome|Flexible Ureteroscopy Arm|"The number of patients who had a complication after the flexible ureteroscopy operation in the first month following the operation.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299326|NCT03023488|EG000|Reported Event|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
11299327|NCT03023553|BG000|Baseline|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299328|NCT03023553|BG001|Baseline|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299329|NCT03023553|BG002|Baseline|Total|Total of all reporting groups
10848371|NCT00289770|FG000|Participant Flow|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10848372|NCT00289770|OG000|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
11299330|NCT03023553|FG000|Participant Flow|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299331|NCT03023553|FG001|Participant Flow|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299332|NCT03023553|OG000|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299333|NCT03023553|OG001|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299334|NCT03023553|EG000|Reported Event|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
11299335|NCT03023553|EG001|Reported Event|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299336|NCT03023683|BG000|Baseline|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299337|NCT03023683|BG001|Baseline|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299338|NCT03023683|BG002|Baseline|Total|Total of all reporting groups
11299339|NCT03023683|FG000|Participant Flow|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299340|NCT03023683|FG001|Participant Flow|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299341|NCT03023683|OG000|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299342|NCT03023683|OG001|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299343|NCT03023683|EG000|Reported Event|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299344|NCT03023683|EG001|Reported Event|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
11299345|NCT03023709|BG000|Baseline|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
11299346|NCT03023709|BG001|Baseline|Study Phase (LAIV4)|"Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
11299347|NCT03023709|BG002|Baseline|Total|Total of all reporting groups
11299348|NCT03023709|FG000|Participant Flow|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
11299349|NCT03023709|FG001|Participant Flow|Study Phase (LAIV4)|"Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
11299350|NCT03023709|OG000|Outcome|Pilot Phase|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
11299351|NCT03023709|OG001|Outcome|Study Phase|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
11299352|NCT03023709|OG000|Outcome|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
11299353|NCT03023709|OG001|Outcome|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
11299354|NCT03023709|EG000|Reported Event|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
11299355|NCT03023709|EG001|Reported Event|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
11299356|NCT03023722|BG000|Baseline|All Subjects|"Patients with advanced metastatic pancreatic cancer who have measurable disease~anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle"
11299357|NCT03023722|FG000|Participant Flow|All Subjects|"Patients with advanced metastatic pancreatic cancer who have measurable disease~anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle"
11299358|NCT03023722|OG000|Outcome|All Subjects|"Patients with advanced metastatic pancreatic cancer who have measurable disease~anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle"
11299359|NCT03023722|EG000|Reported Event|All Subjects|"Patients with advanced metastatic pancreatic cancer who have measurable disease~anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle"
11299360|NCT03023826|BG000|Baseline|All Participants|Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions, LY3202626 tablet (T1) under fasting conditions and LY3202626 tablet (T1) following a high-fat meal.
11299361|NCT03023826|FG000|Participant Flow|Sequence (ACB)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast."
11299362|NCT03023826|FG001|Participant Flow|Sequence (CAB)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast."
11299363|NCT03023826|FG002|Participant Flow|Sequence (BAC)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast."
11299364|NCT03023826|FG003|Participant Flow|Sequence (ABC)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast."
11299365|NCT03023826|FG004|Participant Flow|Sequence (BCA)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast."
11299366|NCT03023826|FG005|Participant Flow|Sequence (CBA)|"A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.~B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.~C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.."
11299367|NCT03023826|OG000|Outcome|12 mg LY3202626 (R-Fasting)|Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
11299368|NCT03023826|OG001|Outcome|12 mg LY3202626 (T1-Fasting)|Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
11299369|NCT03023826|OG002|Outcome|12 mg LY3202626 (T1-Fed)|Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
11299370|NCT03023826|EG000|Reported Event|12 mg LY3202626 (R-Fasting)|Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.
11299371|NCT03023826|EG001|Reported Event|12 mg LY3202626 (T1-Fasting)|Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.
11299372|NCT03023826|EG002|Reported Event|12 mg LY3202626 (T1-Fed)|Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.
11299373|NCT03023878|BG000|Baseline|Blinatumomab|"Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time.~An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days.~There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death."
11299374|NCT03023878|FG000|Participant Flow|Blinatumomab|"Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time.~An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days.~There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death."
11335797|NCT03557034|OG001|Outcome|Kardia Monitoring|"Kardia Mobile/Kardia Pro~Kardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."
11335798|NCT03557034|EG000|Reported Event|Standard of Care Monitoring|"Standard of Care~This is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit."
11335799|NCT03557034|EG001|Reported Event|Kardia Monitoring|"Kardia Mobile/Kardia Pro~Kardia Monitoring: Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software."
11299375|NCT03023878|OG000|Outcome|Blinatumomab|"Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time.~An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days.~There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death."
10971597|NCT00916032|FG001|Participant Flow|One 3000 IU Vial Then Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
10971598|NCT00916032|OG000|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
11335824|NCT03557333|EG000|Reported Event|24-Week Treatment Group|Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24 weeks.
11335825|NCT03557333|EG001|Reported Event|52-Week Treatment Group|Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 52 weeks. Participants in this treatment group are subset of those included in the 24-Week Treatment Group.
10971599|NCT00916032|OG001|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
10971600|NCT00916032|EG000|Reported Event|One 3000 International Unit (IU) Vial|
10971601|NCT00916032|EG001|Reported Event|Two 1500 IU Vials|
11335826|NCT03557372|BG000|Baseline|Mathematical Model-Adapted Radiation|"Mathematical Model-Adapted Radiation Fractionation Schedule~Mathematical Model-Adapted Radiation Fractionation Schedule: - Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks~Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.~Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment."
11335827|NCT03557372|FG000|Participant Flow|Mathematical Model-Adapted Radiation|"Mathematical Model-Adapted Radiation Fractionation Schedule~Mathematical Model-Adapted Radiation Fractionation Schedule: - Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks~Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.~Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment."
11335828|NCT03557372|OG000|Outcome|Mathematical Model-Adapted Radiation|"Mathematical Model-Adapted Radiation Fractionation Schedule~Mathematical Model-Adapted Radiation Fractionation Schedule: - Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks~Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.~Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment."
11335829|NCT03557372|EG000|Reported Event|Mathematical Model-Adapted Radiation|"Mathematical Model-Adapted Radiation Fractionation Schedule~Mathematical Model-Adapted Radiation Fractionation Schedule: - Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks~Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.~Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment."
11335830|NCT03557476|BG000|Baseline|Octacosanol|"Two capsules (20-mg x 2) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed daily by the octacosanol group for six days, one capsule 30 minutes after morning and afternoon meals.~Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day"
11335831|NCT03557476|BG001|Baseline|Placebo|"A placebo pill was taken twice daily in replacement of the octacosanol supplement~Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement"
11335832|NCT03557476|BG002|Baseline|Total|Total of all reporting groups
11335833|NCT03557476|FG000|Participant Flow|Octacosanol|"Two capsules (20-mg x 2) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed daily by the octacosanol group for six days, one capsule 30 minutes after morning and afternoon meals.~Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day"
11335834|NCT03557476|FG001|Participant Flow|Placebo|"A placebo pill was taken twice daily in replacement of the octacosanol supplement~Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement"
11335835|NCT03557476|OG000|Outcome|Octacosanol|"Two capsules (20-mg x 2) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed daily by the octacosanol group for six days, one capsule 30 minutes after morning and afternoon meals.~Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day"
11335836|NCT03557476|OG001|Outcome|Placebo|"A placebo pill was taken twice daily in replacement of the octacosanol supplement~Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement"
11335837|NCT03557476|EG000|Reported Event|Octacosanol|"Two capsules (20-mg x 2) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed daily by the octacosanol group for six days, one capsule 30 minutes after morning and afternoon meals.~Octacosanol: One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day"
11335838|NCT03557476|EG001|Reported Event|Placebo|"A placebo pill was taken twice daily in replacement of the octacosanol supplement~Placebo: A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement"
11299376|NCT03023878|EG000|Reported Event|Blinatumomab|"Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time.~An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days.~There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death."
11299377|NCT03023891|BG000|Baseline|Prednisone|"Each participant will received a single dose of oral 60 mg of prednisone~Prednisone: Prednisone 60 mg tablet once"
11299378|NCT03023891|FG000|Participant Flow|Prednisone|"Each participant will received a single dose of oral 60 mg of prednisone~Prednisone: Prednisone 60 mg tablet once"
11299379|NCT03023891|OG000|Outcome|Prednisone|"Each participant will received a single dose of oral 60 mg of prednisone~Prednisone: Prednisone 60 mg tablet once"
11299380|NCT03023891|EG000|Reported Event|Prednisone|"Each participant will received a single dose of oral 60 mg of prednisone~Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60 mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug~Prednisone: Prednisone 60 mg tablet once"
11299381|NCT03024112|BG000|Baseline|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
11299382|NCT03024112|BG001|Baseline|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
11299383|NCT03024112|BG002|Baseline|Total|Total of all reporting groups
11299384|NCT03024112|FG000|Participant Flow|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
11299385|NCT03024112|FG001|Participant Flow|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
11299386|NCT03024112|OG000|Outcome|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
11299387|NCT03024112|OG001|Outcome|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
11299388|NCT03024112|EG000|Reported Event|Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen|"The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier~Heated humified high-flow nasal cannula Oxygen"
11299389|NCT03024112|EG001|Reported Event|Standard Oxygen Therapy|"The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.~Standard oxygen therapy"
11299390|NCT03024606|BG000|Baseline|Texting Group|"text messages focused on smoking cessation and pregnancy~text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion."
11299391|NCT03024606|BG001|Baseline|Control Group|No text messages
11299392|NCT03024606|BG002|Baseline|Total|Total of all reporting groups
11299393|NCT03024606|FG000|Participant Flow|Texting Group|"text messages focused on smoking cessation and pregnancy~text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion."
11299394|NCT03024606|FG001|Participant Flow|Control Group|No text messages
11335839|NCT03557658|BG000|Baseline|Normal Hepatic Function|Healthy subjects with normal hepatic function. Each subject will receive a single oral dose of bexagliflozin, 20 mg.
11335840|NCT03557658|BG001|Baseline|Moderate Hepatic Impairment|Subjects with hepatic impairment conforming to the Child-Pugh class B (total score 7-9). Each subject will receive a single oral dose of bexagliflozin tablet, 20 mg
11335841|NCT03557658|BG002|Baseline|Total|Total of all reporting groups
11335842|NCT03557658|FG000|Participant Flow|Normal Hepatic Function|Healthy subjects with normal hepatic function. Each subject will receive a single oral dose of bexagliflozin, 20 mg.
11335843|NCT03557658|FG001|Participant Flow|Moderate Hepatic Impairment|Subjects with hepatic impairment conforming to the Child-Pugh class B (total score 7-9). Each subject will receive a single oral dose of bexagliflozin tablet, 20 mg
11335844|NCT03557658|OG000|Outcome|Normal Hepatic Function|Healthy subjects with normal hepatic function. Each subject will receive a single oral dose of bexagliflozin, 20 mg.
11299395|NCT03024606|OG000|Outcome|Texting Group|"text messages focused on smoking cessation and pregnancy~text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion."
11299396|NCT03024606|OG001|Outcome|Control Group|No text messages
11299397|NCT03024606|EG000|Reported Event|Texting Group|"text messages focused on smoking cessation and pregnancy~text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion."
11299398|NCT03024606|EG001|Reported Event|Control Group|No text messages
11299399|NCT03024970|BG000|Baseline|Overall Study|Total Participants
11299400|NCT03024970|FG000|Participant Flow|Test Lens Then Control Lens|"Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.~stenfilcon A lens with solution additive (test): contact lens stenfilcon A lens (Control): contact lens"
11299401|NCT03024970|FG001|Participant Flow|Control Lens Then Test Lens|"Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.~stenfilcon A lens (control): contact lens stenfilcon A lens with solution additive (test): contact lens"
11299402|NCT03024970|OG000|Outcome|Stenfilcon A Lens With Solution Additive (Test)|"Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.~stenfilcon A lens with solution additive (test): silicone hydrogel lens"
11299403|NCT03024970|OG001|Outcome|Stenfilcon A Lens (Control)|"Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.~stenfilcon A lens (control): contact lens"
11299404|NCT03024970|EG000|Reported Event|Stenfilcon A Lens With Solution Additive (Test)|"Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.~stenfilcon A lens with solution additive (test): silicone hydrogel lens"
11299405|NCT03024970|EG001|Reported Event|Stenfilcon A Lens (Control)|"Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.~stenfilcon A lens (control): contact lens"
11299406|NCT03025217|BG000|Baseline|TLC Program|"The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided.~Total Lifestyle Coaching (TLC)"
11299407|NCT03025217|FG000|Participant Flow|TLC Program|"The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided.~Total Lifestyle Coaching (TLC)"
11335845|NCT03557658|OG001|Outcome|Moderate Hepatic Impairment|Subjects with hepatic impairment conforming to the Child-Pugh class B (total score 7-9). Each subject will receive a single oral dose of bexagliflozin tablet, 20 mg
10971602|NCT00916058|BG000|Baseline|Dose Level 1|Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
10971603|NCT00916058|BG001|Baseline|Dose Level 2|Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
10971604|NCT00916058|BG002|Baseline|Dose Level 3|Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
10971605|NCT00916058|BG003|Baseline|Dose Level 4|Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
11335846|NCT03557658|EG000|Reported Event|Normal Hepatic Function|Healthy subjects with normal hepatic function. Each subject will receive a single oral dose of bexagliflozin, 20 mg.
11335847|NCT03557658|EG001|Reported Event|Moderate Hepatic Impairment|Subjects with hepatic impairment conforming to the Child-Pugh class B (total score 7-9). Each subject will receive a single oral dose of bexagliflozin tablet, 20 mg
11335848|NCT03557775|BG000|Baseline|Inspiratory Muscle Strength Training|The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).
11335849|NCT03557775|BG001|Baseline|Expiratory Muscle Strength Training|The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).
11335850|NCT03557775|BG002|Baseline|Voice Exercises|The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.
11335851|NCT03557775|BG003|Baseline|Total|Total of all reporting groups
11335852|NCT03557775|FG000|Participant Flow|Inspiratory Muscle Strength Training|The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).
11335853|NCT03557775|FG001|Participant Flow|Expiratory Muscle Strength Training|The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).
11335854|NCT03557775|FG002|Participant Flow|Voice Exercises|"The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.~Voice Exercises: Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement."
11299408|NCT03025217|OG000|Outcome|TLC Program|"The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided.~Total Lifestyle Coaching (TLC)"
11299409|NCT03025217|EG000|Reported Event|TLC Program|"The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided.~Total Lifestyle Coaching (TLC)"
11299410|NCT03025945|BG000|Baseline|Nepafenac 0.3%|"nepafenac 0.3% ophthalmic solution dosed once daily~Nepafenac 0.3%"
11299411|NCT03025945|BG001|Baseline|Saline Solution|"sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily~Saline Solution"
11299412|NCT03025945|BG002|Baseline|Total|Total of all reporting groups
11299413|NCT03025945|FG000|Participant Flow|Nepafenac 0.3%|"nepafenac 0.3% ophthalmic solution dosed once daily~Nepafenac 0.3%"
11299414|NCT03025945|FG001|Participant Flow|Saline Solution|"sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily~Saline Solution"
11299415|NCT03025945|OG000|Outcome|Nepafenac 0.3%|"nepafenac 0.3% ophthalmic solution dosed once daily~Nepafenac 0.3%"
11299416|NCT03025945|OG001|Outcome|Saline Solution|"sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily~Saline Solution"
11299417|NCT03025945|EG000|Reported Event|Nepafenac 0.3%|"nepafenac 0.3% ophthalmic solution dosed once daily~Nepafenac 0.3%"
11299418|NCT03025945|EG001|Reported Event|Saline Solution|"sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily~Saline Solution"
11299419|NCT03026075|BG000|Baseline|Colonoscopy With MCS|"Standard colonoscopy procedure with Motus Cleansing System~Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir."
11299420|NCT03026075|FG000|Participant Flow|Colonoscopy With MCS|"Standard colonoscopy procedure with Motus Cleansing System~Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir."
11299421|NCT03026075|OG000|Outcome|Colonoscopy With MCS|"Standard colonoscopy procedure with Motus Cleansing System~Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir."
11299422|NCT03026075|EG000|Reported Event|Colonoscopy With MCS|"Standard colonoscopy procedure with Motus Cleansing System~Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir."
11299423|NCT03026088|BG000|Baseline|Bisoprolol|Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
11299424|NCT03026088|FG000|Participant Flow|Bisoprolol|Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
11299425|NCT03026088|OG000|Outcome|Bisoprolol|Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
11299426|NCT03026088|EG000|Reported Event|Bisoprolol|Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
11299427|NCT03026166|BG000|Baseline|Rovalpituzumab Tesirine and Nivolumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).~Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression."
11299428|NCT03026166|BG001|Baseline|Rovalpituzumab Tesirine and Nivolumab + Ipilimumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).~After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression."
11299429|NCT03026166|BG002|Baseline|Total|Total of all reporting groups
11299430|NCT03026166|FG000|Participant Flow|Rovalpituzumab Tesirine and Nivolumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).~Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression."
11299431|NCT03026166|FG001|Participant Flow|Rovalpituzumab Tesirine and Nivolumab + Ipilimumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).~After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression."
11299432|NCT03026166|OG000|Outcome|Rovalpituzumab Tesirine and Nivolumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).~Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression."
11299433|NCT03026166|OG001|Outcome|Rovalpituzumab Tesirine and Nivolumab + Ipilimumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).~After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression."
11299434|NCT03026166|EG000|Reported Event|Cohort 1: Rovalpituzumab Tesirine and Nivolumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).~Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression."
11299435|NCT03026166|EG001|Reported Event|Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab|"Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).~After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression."
11299436|NCT03026257|BG000|Baseline|AOHG/CCP|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent
11299437|NCT03026257|BG001|Baseline|AOHG/OFPM|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
11299438|NCT03026257|BG002|Baseline|Biofinity/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299439|NCT03026257|BG003|Baseline|Vita/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299440|NCT03026257|BG004|Baseline|Ultra/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299441|NCT03026257|BG005|Baseline|Oasys/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS
11299442|NCT03026257|BG006|Baseline|Total|Total of all reporting groups
11299443|NCT03026257|FG000|Participant Flow|AOHG/CCP|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent
11299444|NCT03026257|FG001|Participant Flow|AOHG/OFPM|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
11299445|NCT03026257|FG002|Participant Flow|Biofinity/HMPS|Habitual silicone hydrogel (SiHy) contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
11299446|NCT03026257|FG003|Participant Flow|Vita/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299447|NCT03026257|FG004|Participant Flow|Ultra/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299448|NCT03026257|FG005|Participant Flow|Oasys/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS
10971606|NCT00916058|BG004|Baseline|Dose Level 5|Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
11299449|NCT03026257|OG000|Outcome|AOHG/CCP|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent
11299450|NCT03026257|OG001|Outcome|AOHG/OFPM|Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
10848373|NCT00289770|EG000|Reported Event|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
10848374|NCT00289783|BG000|Baseline|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
10971607|NCT00916058|BG005|Baseline|Dose Level 6|Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
11299451|NCT03026257|OG002|Outcome|Biofinity/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299452|NCT03026257|OG003|Outcome|Vita/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299453|NCT03026257|OG004|Outcome|Ultra/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS
11299454|NCT03026257|OG005|Outcome|Oasys/HMPS|Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS
11299455|NCT03026257|EG000|Reported Event|AOHG/CCP Ocular|Eyes exposed to AOHG contact lenses and CCP for lens care
11299456|NCT03026257|EG001|Reported Event|AOHG/CCP Nonocular|Subjects exposed to AOHG contact lenses and CCP for lens care
11299457|NCT03026257|EG002|Reported Event|AOHG/OFPM Ocular|Eyes exposed to AOHG contact lenses and OFPM for lens care
11299458|NCT03026257|EG003|Reported Event|AOHG/OFPM Nonocular|Subjects exposed to AOHG contact lenses and OFPM for lens care
11299459|NCT03026257|EG004|Reported Event|Habitual SiHy/MPS Ocular|Eyes exposed to habitual SiHy contact lenses and habitual MPS for lens care
11299460|NCT03026257|EG005|Reported Event|Habitual SiHy/MPS Nonocular|Subjects exposed to habitual SiHy contact lenses and habitual MPS for lens care
11299461|NCT03026283|BG000|Baseline|1: HeartFlow CT-FFR Arm|"All patients who consent will receive HeartFlow CT-FFR and medically acceptable care based on the study protocol, commonly accepted standards of care, and the patients condition.~HeartFLow CT-FFR: Patients receiving CCTA to diagnose stable chest pain or stable angina will receive CT-FFR to estimate rate of flow through the coronary arteries. The rate of flow will be compared to the rate found on Invasive FFR (the gold standard) if the subject receives invasive FFR."
11299462|NCT03026283|FG000|Participant Flow|Initial CCTA|All patients who consent will receive CCTA and medically acceptable care based on commonly accepted standards of care, and the patient's condition. The results of the CCTA will determine whether the patient receives FFR-CT or optimal medical care.
11299463|NCT03026283|FG001|Participant Flow|Optimal Medical Care After CCTA|Patients who receive a CCTA and for whom the results are normal or less than 30% obstructive disease, will be recommended for optimal medical care. This care is the commonly accepted standard of care as recommended by the patient's referring physician. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299464|NCT03026283|FG002|Participant Flow|FFR-CT After CCTA|Patients for whom CCTA results show 30% of more obstructive disease will be referred for FFR-CT. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299465|NCT03026283|FG003|Participant Flow|Optimal Medical Care After FFR-CT|Patients with negative FFR-CT and CCTA results showing 30 to 49% obstructive disease will be recommended for optimal medical care with their Cardiologist, and patients with positive FFR-CT and CCTA results showing 30 to 49% obstructive disease will be recommended for stress testing. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299466|NCT03026283|FG004|Participant Flow|Stress Testing After FFR-CT|Patients with 50% to 69% obstructive disease on CCTA and negative FFR-CT will be recommended for stress testing. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299467|NCT03026283|FG005|Participant Flow|ICA/Diagnostic Catheterization After FFR-CT|Patients with 50 to 69% obstructive disease and positive FFR-CT will be referred for diagnostic catheterization and patients with 70% obstructive disease or greater by CCTA will be referred for diagnostic catheterization. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299468|NCT03026283|FG006|Participant Flow|Optimal Care After Stress Test|Patients who undergo stress testing will be referred to optimal medical care if the results are negative. (The referring physician will make all treatment decisions, and may not follow the recommendation provided by the study team).
11299469|NCT03026283|FG007|Participant Flow|ICA/Diagnostic Catheterization After Stress Test|Patients who undergo stress testing will be referred to diagnostic catheterization if the result is positive.
11299470|NCT03026283|OG000|Outcome|CCTA|.CCTA Alone
11299471|NCT03026283|OG001|Outcome|FFR-CT After CCTA|FFR-CT After CCTA
11299472|NCT03026283|OG000|Outcome|CCTA Reading: Less Experienced Reader Vs. More Experience|"All CCTA results were read by readers with fewer than10 years experience and who spent at least one full time day per week reading CCTA and FFR-CT. These are the official results performed during the course of care. We tested agreement with expert reader with more than 10 years experience, who supervised the practice and did not routinely perform daily clinical reads.~The arm initially had 572 subjects who completed CCTA exams. However, detailed scan results for 5 patients were inadvertently removed from the server before the second reader could review, and therefore, could not be included in the analysis."
11299473|NCT03026283|OG000|Outcome|Less Experienced Reader Vs. More Experience|CCTA and FFR-CT results read by readers with fewer than10 years experience and who spent at least one full time day per week reading CCTA and FFR-CT. These are the official results performed during the course of care. We tested agreement with expert reader with more than 10 years experience.
11299474|NCT03026283|OG000|Outcome|All Study Participants|This is a safety measure to assess urgent and emergency returns for services within 90 days of the initial encounter. Emergency returns for Acute Myocardial Infarction or urgent need for revascularization, were evaluated by the study safety committee to determine whether participation in the study had contributed to major adverse event.
11299475|NCT03026283|OG000|Outcome|Patients Initially Referred for Cardiac Cath|These patients were referred for diagnostic Cath, because their CCTA was positive and their FFR-CT was positive.
11335855|NCT03557775|OG000|Outcome|Inspiratory Muscle Strength Training|The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).
11335856|NCT03557775|OG001|Outcome|Expiratory Muscle Strength Training|The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).
11299476|NCT03026283|OG001|Outcome|Patients Initially Referred for Stress Tesintg|These patients had Moderate (50 to 69% stenoisis) finding on CCTA with Negative FFR-CT. They were referred to stress testing by protocol. One patient underwent a negative diagnostic cardiac cath. One patient was treated and released fro the ED for chest pain.
11299477|NCT03026283|OG002|Outcome|Referred for Optimla Medical Care After CCTA|These patients were referred to optimal medical care after CCTA. They returned to the Emergency Department with Chest Pain and were discharged after evaluation and noninvasive treatment.
11299478|NCT03026283|EG000|Reported Event|Patients Referred for Cardiac Intervention|Patients for whom Cardiac Catheterization was recommended after protocol testing.
11299479|NCT03026283|EG001|Reported Event|Patients Referred for Stress Tesing|Patients for whom stress testing was recommended after FFR-CT
11299480|NCT03026283|EG002|Reported Event|Patients Referred for Optimal Medical Care|Patients for whom optimal medical care was recommended after protocol testing.
11299481|NCT03026530|BG000|Baseline|Pulmonary Recruitment Maneuver|"Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.~Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299482|NCT03026530|BG001|Baseline|Control Group|"Ordinary ventilation at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299483|NCT03026530|BG002|Baseline|Total|Total of all reporting groups
11299484|NCT03026530|FG000|Participant Flow|Pulmonary Recruitment Maneuver|"Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.~Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299485|NCT03026530|FG001|Participant Flow|Control Group|"Ordinary ventilation at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299486|NCT03026530|OG000|Outcome|Pulmonary Recruitment Maneuver|"Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.~Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299487|NCT03026530|OG001|Outcome|Control Group|"Ordinary ventilation at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299488|NCT03026530|EG000|Reported Event|Pulmonary Recruitment Maneuver|"Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.~Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299489|NCT03026530|EG001|Reported Event|Control Group|"Ordinary ventilation at the end of laparoscopic bariatric surgery.~Laparoscopic bariatric surgery~Ventilator"
11299490|NCT03026556|BG000|Baseline|Dabigatran|Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran .
10971608|NCT00916058|BG006|Baseline|Phase 2|Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)
11299491|NCT03026556|BG001|Baseline|Rivaroxaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .
11299492|NCT03026556|BG002|Baseline|Apixaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .
11299493|NCT03026556|BG003|Baseline|Total|Total of all reporting groups
11299494|NCT03026556|FG000|Participant Flow|Dabigatran|Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran .
11299495|NCT03026556|FG001|Participant Flow|Rivaroxaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .
11299496|NCT03026556|FG002|Participant Flow|Apixaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .
11299497|NCT03026556|OG000|Outcome|Dabigatran (Dabigatran vs Rivaroxaban)|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
11299498|NCT03026556|OG001|Outcome|Rivaroxaban (Dabigatran vs Rivaroxaban)|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
11299499|NCT03026556|OG002|Outcome|Dabigatran (Dabigatran vs Apixaban)|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
11299500|NCT03026556|OG003|Outcome|Apixaban (Dabigatran vs Apixaban)|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
11299501|NCT03026556|EG000|Reported Event|Dabigatran|Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran.
11299502|NCT03026556|EG001|Reported Event|Rivaroxaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban.
11299503|NCT03026556|EG002|Reported Event|Apixaban|OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban.
11299504|NCT03026777|BG000|Baseline|Fluid Loading|"(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.~intravenous crystalloid fluid, 500 mL"
11299505|NCT03026777|BG001|Baseline|Usual Care|No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
11299506|NCT03026777|BG002|Baseline|Total|Total of all reporting groups
11299507|NCT03026777|FG000|Participant Flow|Fluid Loading|"(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.~intravenous crystalloid fluid, 500 mL"
11299508|NCT03026777|FG001|Participant Flow|Usual Care|No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
11299509|NCT03026777|OG000|Outcome|Fluid Loading|"(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.~intravenous crystalloid fluid, 500 mL"
11299510|NCT03026777|OG001|Outcome|Usual Care|No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
11299511|NCT03026777|EG000|Reported Event|Fluid Loading|"(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.~intravenous crystalloid fluid, 500 mL"
11299512|NCT03026777|EG001|Reported Event|Usual Care|No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
11299513|NCT03026803|BG000|Baseline|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
11299514|NCT03026803|FG000|Participant Flow|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
11299515|NCT03026803|OG000|Outcome|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
11299516|NCT03026803|EG000|Reported Event|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
11299517|NCT03027466|BG000|Baseline|Baseline Affirmation and Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299518|NCT03027466|BG001|Baseline|Baseline Affirmation and No Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299519|NCT03027466|BG002|Baseline|No Baseline Affirmation and Affirmation Texts|"Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11335857|NCT03557775|OG002|Outcome|Voice Exercises|The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.
11335858|NCT03557775|EG000|Reported Event|Inspiratory Muscle Strength Training|The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).
11335859|NCT03557775|EG001|Reported Event|Expiratory Muscle Strength Training|The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).
10971609|NCT00916058|BG007|Baseline|Total|Total of all reporting groups
11299520|NCT03027466|BG003|Baseline|No Baseline Affirmation and No Affirmation Texts|"Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299521|NCT03027466|BG004|Baseline|Total|Total of all reporting groups
11299522|NCT03027466|FG000|Participant Flow|Baseline Affirmation and Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition).Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299523|NCT03027466|FG001|Participant Flow|Baseline Affirmation and No Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299524|NCT03027466|FG002|Participant Flow|No Baseline Affirmation and Affirmation Texts|"Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299525|NCT03027466|FG003|Participant Flow|No Baseline Affirmation and No Affirmation Texts|"Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299526|NCT03027466|OG000|Outcome|Baseline Affirmation and Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299527|NCT03027466|OG001|Outcome|Baseline Affirmation and No Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299528|NCT03027466|OG002|Outcome|No Baseline Affirmation and Affirmation Texts|"Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299529|NCT03027466|OG003|Outcome|No Baseline Affirmation and No Affirmation Texts|"Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299530|NCT03027466|EG000|Reported Event|Baseline Affirmation and Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299531|NCT03027466|EG001|Reported Event|Baseline Affirmation and No Affirmation Texts|"Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299532|NCT03027466|EG002|Reported Event|No Baseline Affirmation and Affirmation Texts|"Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299533|NCT03027466|EG003|Reported Event|No Baseline Affirmation and No Affirmation Texts|"Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)~Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message."
11299534|NCT03027557|BG000|Baseline|Combined Treatment.|15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
11299535|NCT03027557|BG001|Baseline|Denosumab Monotherapy|16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
11299536|NCT03027557|BG002|Baseline|Placebo|15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
11299537|NCT03027557|BG003|Baseline|Total|Total of all reporting groups
11299538|NCT03027557|FG000|Participant Flow|Combined Treatment.|15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
11299539|NCT03027557|FG001|Participant Flow|Denosumab Monotherapy|16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
11299540|NCT03027557|FG002|Participant Flow|Placebo|15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
11299541|NCT03027557|OG000|Outcome|Combined Treatment.|15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
11299542|NCT03027557|OG001|Outcome|Denosumab Monotherapy|16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
11299543|NCT03027557|OG002|Outcome|Placebo|15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
11299544|NCT03027557|EG000|Reported Event|Combined Treatment.|15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
11299545|NCT03027557|EG001|Reported Event|Denosumab Monotherapy|16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
11299546|NCT03027557|EG002|Reported Event|Placebo|15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
11299547|NCT03027661|BG000|Baseline|Control Group|"Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock~0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma"
11299548|NCT03027661|BG001|Baseline|Study Group|"Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.~Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma"
11299549|NCT03027661|BG002|Baseline|Total|Total of all reporting groups
11299550|NCT03027661|FG000|Participant Flow|Control Group|"Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock~0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma"
11299551|NCT03027661|FG001|Participant Flow|Study Group|"Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.~Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma"
11299552|NCT03027661|OG000|Outcome|Control Group|"Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock~0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma"
11299553|NCT03027661|OG001|Outcome|Study Group|"Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.~Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma"
11299554|NCT03027661|EG000|Reported Event|Control Group|"Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock~0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma"
11299555|NCT03027661|EG001|Reported Event|Study Group|"Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.~Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma"
11299556|NCT03028012|BG000|Baseline|Ketorolac|"Participants may be randomized to receive Ketorolac for their TPI.~Ketorolac: Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11299557|NCT03028012|BG001|Baseline|Lidocaine|"Participants may be randomized to receive Lidocaine for their TPI.~Lidocaine: Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11299558|NCT03028012|BG002|Baseline|Dexamethasone|"Participants may be randomized to receive Dexamethasone for their TPI.~Dexamethasone: Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11299559|NCT03028012|BG003|Baseline|Total|Total of all reporting groups
11299560|NCT03028012|FG000|Participant Flow|Ketorolac|"Participants may be randomized to receive Ketorolac for their TPI.~Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299561|NCT03028012|FG001|Participant Flow|Lidocaine|"Participants may be randomized to receive Lidocaine for their TPI.~Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299562|NCT03028012|FG002|Participant Flow|Dexamethasone|"Participants may be randomized to receive Dexamethasone for their TPI.~Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL~Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299563|NCT03028012|OG000|Outcome|Ketorolac|"Participants may be randomized to receive Ketorolac for their TPI.~Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299564|NCT03028012|OG001|Outcome|Lidocaine|"Participants may be randomized to receive Lidocaine for their TPI.~Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299565|NCT03028012|OG002|Outcome|Dexamethasone|"Participants may be randomized to receive Dexamethasone for their TPI.~Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299566|NCT03028012|OG000|Outcome|Ketorolac|"Participants may be randomized to receive Ketorolac for their TPI.~Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. Participants may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs."
11299567|NCT03028012|EG000|Reported Event|Ketorolac|"Participants may be randomized to receive Ketorolac for their TPI.~Ketorolac: Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11299568|NCT03028012|EG001|Reported Event|Lidocaine|"Participants may be randomized to receive Lidocaine for their TPI.~Lidocaine: Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11299569|NCT03028012|EG002|Reported Event|Dexamethasone|"Participants may be randomized to receive Dexamethasone for their TPI.~Dexamethasone: Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs."
11335860|NCT03557775|EG002|Reported Event|Voice Exercises|The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.
11335861|NCT03557801|BG000|Baseline|Standard of Care Mammography|Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.
11299570|NCT03028025|BG000|Baseline|TR Band Only|TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
11299571|NCT03028025|BG001|Baseline|Statseal With TR Band|StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
11299572|NCT03028025|BG002|Baseline|Total|Total of all reporting groups
11299573|NCT03028025|FG000|Participant Flow|TR Band Only|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
11299574|NCT03028025|FG001|Participant Flow|Statseal With TR Band|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
11299575|NCT03028025|OG000|Outcome|TR Band Only|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
11299576|NCT03028025|OG001|Outcome|Statseal With TR Band|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
11299577|NCT03028025|EG000|Reported Event|TR Band Only|TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
11299578|NCT03028025|EG001|Reported Event|Statseal With TR Band|StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
11335862|NCT03557801|BG001|Baseline|Mammography With Community Health Worker (Individual)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11299579|NCT03028103|BG000|Baseline|Part A|Subjects enrolled in Part A received treatment with oral tazemetostat tablets 400 mg twice daily for 24 days beginning on Day 1. Blood samples for the analysis of plasma tazemetostat and its metabolites concentrations were collected predose and over 8 hours after the morning dose of tazemetostat on Day 15. Subjects received fluconazole 400 mg once daily for 4 days starting on Day 16. On Day 19, blood samples for the analysis of plasma tazemetostat, its metabolites, and fluconazole were collected predose and over 8 hours after the morning tazemetostat dose. Tazemetostat 400 mg twice daily continued through Day 24. Subjects then received tazemetostat 800 mg twice daily starting on Day 25.
11299580|NCT03028103|BG001|Baseline|Part B|Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
11299581|NCT03028103|BG002|Baseline|Total|Total of all reporting groups
11299582|NCT03028103|FG000|Participant Flow|Part A|Subjects enrolled in Part A received treatment with oral tazemetostat tablets 400 mg twice daily for 24 days beginning on Day 1. Blood samples for the analysis of plasma tazemetostat and its metabolites concentrations were collected predose and over 8 hours after the morning dose of tazemetostat on Day 15. Subjects received fluconazole 400 mg once daily for 4 days starting on Day 16. On Day 19, blood samples for the analysis of plasma tazemetostat, its metabolites, and fluconazole were collected predose and over 8 hours after the morning tazemetostat dose. Tazemetostat 400 mg twice daily continued through Day 24. Subjects then received tazemetostat 800 mg twice daily starting on Day 25.
11299583|NCT03028103|FG001|Participant Flow|Part B|Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
11299584|NCT03028103|OG000|Outcome|Part A|Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
11299585|NCT03028103|OG000|Outcome|Part B|Part B: Subjects enrolled in Part B will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg BID will begin on Day 2. On Day 16, subjects again will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also will receive omeprazole 20 mg once daily in the morning on Days 16 through 19.
11299586|NCT03028103|OG000|Outcome|Part A|Subjects enrolled in Part A received treatment with oral tazemetostat tablets 400 mg twice daily for 24 days beginning on Day 1. Blood samples for the analysis of plasma tazemetostat and its metabolites concentrations were collected predose and over 8 hours after the morning dose of tazemetostat on Day 15. Subjects received fluconazole 400 mg once daily for 4 days starting on Day 16. On Day 19, blood samples for the analysis of plasma tazemetostat, its metabolites, and fluconazole were collected predose and over 8 hours after the morning tazemetostat dose. Tazemetostat 400 mg twice daily continued through Day 24. Subjects then received tazemetostat 800 mg twice daily starting on Day 25.
11299587|NCT03028103|OG001|Outcome|Part B|Subjects enrolled in Part B received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg twice daily began on Day 2. On Day 16, subjects again received single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also received omeprazole 20 mg once daily in the morning on Days 16 through 19. Blood samples for analysis of plasma repaglinide, repaglinide metabolites, omeprazole, 5-OH-omeprazole, and omeprazole sulfone were collected predose and over 7 hours after administration on Day 1 and Day 16. Blood samples for analysis of plasma tazemetostat and metabolites were collected over 8 hours after administration of the morning dose on Day 16 and Day 19.
11299588|NCT03028103|OG000|Outcome|Lymphoma|Subjects with B-cell lymphomas
11299589|NCT03028103|OG001|Outcome|Advanced Solid Tumors|Subjects with Advanced Solid Tumors
11299590|NCT03028103|EG000|Reported Event|Part A|Part A: Subjects enrolled in Part A will receive treatment with oral tazemetostat tablets 400 mg BID for 24 days beginning on Day 1. Subjects will receive fluconazole 400 mg once daily for 4 days starting on Day 16. Tazemetostat 400 mg BID will continue through Day 24. Subjects will then receive tazemetostat 800 mg BID starting on Day 25.
10971610|NCT00916058|FG000|Participant Flow|Dose Level 1|"Dose Level 1; Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 30 mg/m2 given on day 2 of melphalan~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)"
10971611|NCT00916058|FG001|Participant Flow|Dose Level 2|"Dose Level 2; Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m2 given on the 2nd day of melphalan"
10971612|NCT00916058|FG002|Participant Flow|Dose Level 3|"Dose Level 3; Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m2 given on the 2nd day of melphalan"
11299591|NCT03028103|EG001|Reported Event|Part B|Part B: Subjects enrolled in Part B will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg on Day 1. Administration of tazemetostat 800 mg BID will begin on Day 2. On Day 16, subjects again will receive single oral doses of repaglinide 0.25 mg and omeprazole 20 mg approximately 1 hour after the morning dose of tazemetostat. Subjects also will receive omeprazole 20 mg once daily in the morning on Days 16 through 19.
11299592|NCT03028129|BG000|Baseline|Treatment|Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
11299593|NCT03028129|BG001|Baseline|Control|Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
11299594|NCT03028129|BG002|Baseline|Total|Total of all reporting groups
11299595|NCT03028129|FG000|Participant Flow|Treatment|Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
11299596|NCT03028129|FG001|Participant Flow|Control|Each subject received two weekly supervised oral doses of placebo, without the active ingredient, similar in size, weight, color, taste and odor.
11299597|NCT03028129|OG000|Outcome|Treatment|Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
11299598|NCT03028129|OG001|Outcome|Control|Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
11299599|NCT03028129|EG000|Reported Event|Treatment|Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
11299600|NCT03028129|EG001|Reported Event|Control|Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
11332863|NCT03502798|BG001|Baseline|Scanning a/LCI (Jacobi)|"Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.~A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.)."
11332864|NCT03502798|BG002|Baseline|Total|Total of all reporting groups
11332865|NCT03502798|FG000|Participant Flow|Scanning a/LCI (Pilot)|Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
11332866|NCT03502798|FG001|Participant Flow|Scanning a/LCI (Jacobi)|"Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.~A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.)."
11332867|NCT03502798|OG000|Outcome|Scanning a/LCI (Pilot)|"Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.~The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements."
11333896|NCT03521115|BG000|Baseline|Smart Choices 4 Teens|"A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component.~Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other."
10971613|NCT00916058|FG003|Participant Flow|Dose Level 4|"Dose Level 4; Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m2 given on the 1st and 2nd day of melphalan"
11299601|NCT03028142|BG000|Baseline|Overall|All patients before the start of the study treatment sequence
11299602|NCT03028142|FG000|Participant Flow|Placebo Then Low Dose RPL554 Then High Dose RPL554|Placebo twice daily plus 10 mcg tiotropium once daily for 3 days then 1.5 mg RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then 6 mg RPL554 twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299603|NCT03028142|FG001|Participant Flow|Low Dose Dose RPL554 Then High Dose RPL554 Then Placebo|1.5 mg RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then 6 mg RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then placebo twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299604|NCT03028142|FG002|Participant Flow|High Dose RPL554 Then Placebo Then Low Dose RPL554|High dose RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then placebo twice daily plus 10 mcg tiotropium once daily for 3 days then 1.5 mg RPL554 twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299605|NCT03028142|FG003|Participant Flow|High Dose RPL554 Then Low Dose RPL554 Then Placebo|High dose RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then 1.5 mg RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then placebo twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299606|NCT03028142|FG004|Participant Flow|Low Dose RPL554 Then Placebo Then High Dose RPL554|Low dose RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then placebo twice daily plus 10 mcg tiotropium once daily for 3 days then 6 mg RPL554 twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299607|NCT03028142|FG005|Participant Flow|Placebo Then High Dose RPL554 Then Low Dose RPL554|Placebo twice daily plus 10 mcg tiotropium once daily for 3 days then 6 mg RPL554 twice daily plus 10 mcg tiotropium once daily for 3 days then 1.5 mg RPL554 twice daily plus 10 mcg tiotropium for 3 days, with a 7-21 day washout period between treatments
11299608|NCT03028142|OG000|Outcome|Lower Dose Nebulised Treatment|"1.5 mg nebulised RPL554 twice daily plus 10 mcg tiotropium dry powder inhaler (DPI) once daily for 3 days~1.5 mg RPL554 plus tiotropium"
11299609|NCT03028142|OG001|Outcome|Higher Dose Nebulised Treatment|"6 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days~6 mg RPL554 plus tiotropium"
11299610|NCT03028142|OG002|Outcome|Placebo|"Nebulised RPL554 matched placebo twice daily plus 10 mcg tiotropium DPI once daily for 3 days~Placebo plus tiotropium"
11299611|NCT03028142|OG000|Outcome|Lower Dose Nebulised Treatment|"1.5 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days~1.5 mg RPL554 plus tiotropium"
11299612|NCT03028142|EG000|Reported Event|Lower Dose Nebulised Treatment|"1.5 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days~1.5 mg RPL554 plus tiotropium"
11299613|NCT03028142|EG001|Reported Event|Higher Dose Nebulised Treatment|"6 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days~6 mg RPL554 plus tiotropium"
11299614|NCT03028142|EG002|Reported Event|Placebo|"Nebulised RPL554 matched placebo twice daily plus 10 mcg tiotropium DPI once daily for 3 days~Placebo plus tiotropium"
11299615|NCT03028220|BG000|Baseline|Real Time Continuous Glucose Monitoring|"Use of Dexcom G5 continuous glucose monitoring~Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values"
11299616|NCT03028220|BG001|Baseline|Flash Glucose Monitoring|"Use of Abbott FreeStyle Libre flash glucose monitoring~Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data"
11299617|NCT03028220|BG002|Baseline|Total|Total of all reporting groups
11299618|NCT03028220|FG000|Participant Flow|Real Time Continuous Glucose Monitoring|"Use of Dexcom G5 continuous glucose monitoring~Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values"
11299619|NCT03028220|FG001|Participant Flow|Flash Glucose Monitoring|"Use of Abbott FreeStyle Libre flash glucose monitoring~Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data"
10848375|NCT00289783|BG001|Baseline|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
10848376|NCT00289783|BG002|Baseline|Total|Total of all reporting groups
11299620|NCT03028220|OG000|Outcome|Real Time Continuous Glucose Monitoring|"Use of Dexcom G5 continuous glucose monitoring~Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values"
11299621|NCT03028220|OG001|Outcome|Flash Glucose Monitoring|"Use of Abbott FreeStyle Libre flash glucose monitoring~Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data"
11299622|NCT03028220|EG000|Reported Event|Real Time Continuous Glucose Monitoring|"Use of Dexcom G5 continuous glucose monitoring~Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values"
11299623|NCT03028220|EG001|Reported Event|Flash Glucose Monitoring|"Use of Abbott FreeStyle Libre flash glucose monitoring~Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data"
11333897|NCT03521115|BG001|Baseline|Control Condition|This group was provided with websites where information was available regarding the same topics.
11333898|NCT03521115|BG002|Baseline|Total|Total of all reporting groups
11299624|NCT03028324|BG000|Baseline|Transcranial Magnetic Stimulation (TMS)|"Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.~Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period."
11299625|NCT03028324|FG000|Participant Flow|Transcranial Magnetic Stimulation (TMS)|"Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.~Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period."
11299626|NCT03028324|OG000|Outcome|Transcranial Magnetic Stimulation (TMS)|"Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.~Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period."
11299627|NCT03028324|EG000|Reported Event|Transcranial Magnetic Stimulation (TMS)|"Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.~Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period."
11299628|NCT03028363|BG000|Baseline|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11299629|NCT03028363|BG001|Baseline|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11299630|NCT03028363|BG002|Baseline|Total|Total of all reporting groups
11299631|NCT03028363|FG000|Participant Flow|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11299632|NCT03028363|FG001|Participant Flow|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11299633|NCT03028363|OG000|Outcome|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11299634|NCT03028363|OG001|Outcome|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11299635|NCT03028363|EG000|Reported Event|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11299636|NCT03028363|EG001|Reported Event|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11299637|NCT03028415|BG000|Baseline|AMPLEX|AMPLEX: A bone graft substitute
11299638|NCT03028415|BG001|Baseline|Autogenous Bone Graft (ABG)|Autogenous Bone Graft (ABG): Control material administered by surgical implant
11299639|NCT03028415|BG002|Baseline|Total|Total of all reporting groups
11299640|NCT03028415|FG000|Participant Flow|AMPLEX|AMPLEX: A bone graft substitute
10822252|NCT00075582|OG000|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10971614|NCT00916058|FG004|Participant Flow|Dose Level 5|"Dose Level 5; Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan"
11299641|NCT03028415|FG001|Participant Flow|Autogenous Bone Graft (ABG)|Autogenous Bone Graft (ABG): Control material administered by surgical implant
11299642|NCT03028415|OG000|Outcome|AMPLEX|AMPLEX: A bone graft substitute
11299643|NCT03028415|OG001|Outcome|Autogenous Bone Graft (ABG)|Autogenous Bone Graft (ABG): Control material administered by surgical implant
11299644|NCT03028415|OG000|Outcome|Autogenous Bone Graft (ABG)|Autogenous Bone Graft (ABG): Control material administered by surgical implant
11299645|NCT03028415|EG000|Reported Event|AMPLEX|AMPLEX: A bone graft substitute
11299646|NCT03028415|EG001|Reported Event|Autogenous Bone Graft (ABG)|Autogenous Bone Graft (ABG): Control material administered by surgical implant
11299647|NCT03028467|BG000|Baseline|Placebo|Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299648|NCT03028467|BG001|Baseline|GSK3196165 45 mg|Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299649|NCT03028467|BG002|Baseline|GSK3196165 90 mg|Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299650|NCT03028467|BG003|Baseline|GSK3196165 180 mg|Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299651|NCT03028467|BG004|Baseline|Total|Total of all reporting groups
11299652|NCT03028467|FG000|Participant Flow|Placebo|Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299653|NCT03028467|FG001|Participant Flow|GSK3196165 45 mg|Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299654|NCT03028467|FG002|Participant Flow|GSK3196165 90 mg|Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299655|NCT03028467|FG003|Participant Flow|GSK3196165 180 mg|Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299656|NCT03028467|OG000|Outcome|GSK3196165 45 mg|Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299657|NCT03028467|OG001|Outcome|GSK3196165 90 mg|Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299658|NCT03028467|OG002|Outcome|GSK3196165 180 mg|Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299659|NCT03028467|OG000|Outcome|Placebo|Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299660|NCT03028467|OG001|Outcome|GSK3196165 45 mg|Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299661|NCT03028467|OG002|Outcome|GSK3196165 90 mg|Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299662|NCT03028467|OG003|Outcome|GSK3196165 180 mg|Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299663|NCT03028467|EG000|Reported Event|Placebo|Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299664|NCT03028467|EG001|Reported Event|GSK3196165 45 mg|Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299665|NCT03028467|EG002|Reported Event|GSK3196165 90 mg|Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299666|NCT03028467|EG003|Reported Event|GSK3196165 180 mg|Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
11299667|NCT03028636|BG000|Baseline|All Subjects|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~Surveys were completed at 3, 6, 9, and 12 months during the study."
11299668|NCT03028636|FG000|Participant Flow|All Subjects|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest."
11299669|NCT03028636|OG000|Outcome|All Subjects|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~Surveys were completed at 3, 6, 9, and 12 months during the study."
11299670|NCT03028636|OG000|Outcome|All Subjects at 3 Months|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~This arm represents patients who completed surveys 3 months into the study."
11299671|NCT03028636|OG001|Outcome|All Subjects at 6 Months|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~This arm represents patients who completed surveys 6 months into the study."
11299672|NCT03028636|OG002|Outcome|All Subjects at 9 Months|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~This arm represents patients who completed surveys 9 months into the study."
11299673|NCT03028636|OG003|Outcome|All Subjects at 12 Months|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.~This arm represents patients who completed surveys 12 months into the study."
11299674|NCT03028636|OG000|Outcome|All Subjects|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest."
11299675|NCT03028636|EG000|Reported Event|All Subjects|"Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.~In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest."
10971615|NCT00916058|FG005|Participant Flow|Dose Level 6|"Dose Level 6; Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan"
11299676|NCT03028870|BG000|Baseline|V120083 30 mg|V120083 30 mg taken orally twice daily
11299677|NCT03028870|BG001|Baseline|V120083 60 mg|V120083 60 mg taken orally twice daily
11299678|NCT03028870|BG002|Baseline|Naproxen|Naproxen 500 mg taken orally twice daily
11299679|NCT03028870|BG003|Baseline|Placebo|To match V120083 and/or naproxen taken orally twice daily
11299680|NCT03028870|BG004|Baseline|Total|Total of all reporting groups
11299681|NCT03028870|FG000|Participant Flow|V120083 30 mg|V120083 30 mg taken orally twice daily
11299682|NCT03028870|FG001|Participant Flow|V120083 60 mg|V120083 60 mg taken orally twice daily
11299683|NCT03028870|FG002|Participant Flow|Naproxen|Naproxen 500 mg taken orally twice daily
11299684|NCT03028870|FG003|Participant Flow|Placebo|To match V120083 and/or naproxen taken orally twice daily
11299685|NCT03028870|OG000|Outcome|V120083 30 mg|V120083 30 mg taken orally twice daily
11299686|NCT03028870|OG001|Outcome|V120083 60 mg|V120083 60 mg taken orally twice daily
11299687|NCT03028870|OG002|Outcome|Naproxen|Naproxen 500 mg taken orally twice daily
11299688|NCT03028870|OG003|Outcome|Placebo|To match V120083 and/or naproxen taken orally twice daily
11299689|NCT03028870|EG000|Reported Event|V120083 30 mg|V120083 30 mg taken orally twice daily
11299690|NCT03028870|EG001|Reported Event|V120083 60 mg|V120083 60 mg taken orally twice daily
11299691|NCT03028870|EG002|Reported Event|Naproxen|Naproxen 500 mg taken orally twice daily
11299692|NCT03028870|EG003|Reported Event|Placebo|To match V120083 and/or naproxen taken orally twice daily
11299693|NCT03028974|BG000|Baseline|Group A: 2-4 yo LAIV4 (Return)|"Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299694|NCT03028974|BG001|Baseline|Group D: 6 - 23 Mos Old IIV4 (Return)|"Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
10822253|NCT00075582|OG000|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Stage I/II group IIA patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10971616|NCT00916058|FG006|Participant Flow|Phase 2|"Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan"
11299695|NCT03028974|BG002|Baseline|Group E: 6 - 23 Mos Old IIV4 (Single Yr)|"Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299696|NCT03028974|BG003|Baseline|Group F: 9-13/18-49 yo LAIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299697|NCT03028974|BG004|Baseline|Group G: 9-13/18-49 yo IIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299698|NCT03028974|BG005|Baseline|Total|Total of all reporting groups
11299699|NCT03028974|FG000|Participant Flow|Group A: 2-4 yo LAIV4 (Return)|"Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299700|NCT03028974|FG001|Participant Flow|Group B: 2-4 yo LAIV4 (Single Year)|"Participants are given LAIV4/ FluMist® and participate for single year. For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299701|NCT03028974|FG002|Participant Flow|Group C: 2-4 yo LAIV4 (Swab/Single Yr)|"Participants are given LAIV4/ FluMist® and participate for single year. NP swabs are collected; no blood samples will be collected for this group. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299702|NCT03028974|FG003|Participant Flow|Group D: 6 - 23 Mos Old IIV4 (Returning)|"Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299703|NCT03028974|FG004|Participant Flow|Group E: 6 - 23 Mos Old IIV4 (Single Yr)|"Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299704|NCT03028974|FG005|Participant Flow|Group F: 9-13/18-49 yo LAIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299705|NCT03028974|FG006|Participant Flow|Group G: 9-13/18-49 yo IIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299706|NCT03028974|OG000|Outcome|Group A: 2-4 yo LAIV4 (Return)|"Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299707|NCT03028974|OG001|Outcome|Group D: 6 - 23 Mos Old IIV4 (Returning)|"Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299708|NCT03028974|OG002|Outcome|Group E: 6 - 23 Mos Old IIV4 (Single Yr)|"Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299709|NCT03028974|OG003|Outcome|Group F: 9-13/18-49 yo LAIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299710|NCT03028974|OG004|Outcome|Group G: 9-13/18-49 yo IIV4 (Single Yr)|"Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299711|NCT03028974|OG001|Outcome|Group D: 6 - 23 Mos Old IIV4 (Return)|"Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299712|NCT03028974|EG000|Reported Event|Group A: 2-4 yo LAIV4 (Return)|"Participants were given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization was given at Day 28-32 after Dose 1. All participants in this group was asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299713|NCT03028974|EG001|Reported Event|Group D: 6 - 23 Mos Old IIV4 (Returning)|"Participants were given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization was given at Day 28-32 after Dose 1. Participants were asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299714|NCT03028974|EG002|Reported Event|Group E: 6 - 23 Mos Old IIV4 (Single Yr)|"Participants were given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization was given at Day 28-32 after Dose 1.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299715|NCT03028974|EG003|Reported Event|Group F: 9-13/18-49 yo LAIV4 (Single Yr)|"Participants 9-13-year-old and 18-49-year-old were given LAIV4/ FluMist ®. Participants participated for a single year.~FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray"
11299716|NCT03028974|EG004|Reported Event|Group G: 9-13/18-49 yo IIV4 (Single Yr)|"Participants 9-13-year-old and 18-49-year-old were given IIV4/ Fluzone® and participated for a single year.~Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine"
11299717|NCT03028987|BG000|Baseline|LAIV Randomized|"Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .~FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)"
11299718|NCT03028987|BG001|Baseline|IIV4 Randomized|"Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®~Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)"
11299719|NCT03028987|BG002|Baseline|Total|Total of all reporting groups
11299720|NCT03028987|FG000|Participant Flow|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
11299721|NCT03028987|FG001|Participant Flow|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
11299722|NCT03028987|OG000|Outcome|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
11299723|NCT03028987|OG001|Outcome|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
11299724|NCT03028987|EG000|Reported Event|LAIV Randomized|Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).
11299725|NCT03028987|EG001|Reported Event|IIV4 Randomized|Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
11299726|NCT03029091|BG000|Baseline|EoE + CTD|Participants with eosinophilic esophagitis (EoE) with connective tissue disorder (CTD) receive Losartan
11299727|NCT03029091|BG001|Baseline|EoE - CTD|Participants with eosinophilic esophagitis (EoE) without connective tissue disorder (CTD) receive Losartan
11299728|NCT03029091|BG002|Baseline|Total|Total of all reporting groups
11299729|NCT03029091|FG000|Participant Flow|EoE + CTD|Participants with eosinophilic esophagitis (EoE) with connective tissue disorder (CTD) receive Losartan
11299730|NCT03029091|FG001|Participant Flow|EoE - CTD|Participants with eosinophilic esophagitis (EoE) without connective tissue disorder (CTD) receive Losartan
11299731|NCT03029091|OG000|Outcome|EoE +/- CTD|Participants with eosinophilic esophagitis (EoE) with and without connective tissue disorder (CTD) receive Losartan
11299732|NCT03029091|OG001|Outcome|EoE + CTD|Participants with eosinophilic esophagitis (EoE) with connective tissue disorder (CTD) receive Losartan
11299733|NCT03029091|OG002|Outcome|EoE - CTD|Participants with eosinophilic esophagitis (EoE) without connective tissue disorder (CTD) receive Losartan
11299734|NCT03029091|EG000|Reported Event|EoE +/- CTD|Participants with eosinophilic esophagitis (EoE) with and without connective tissue disorder (CTD) receive Losartan
11299735|NCT03029091|EG001|Reported Event|EoE + CTD|Participants with eosinophilic esophagitis (EoE) with connective tissue disorder (CTD) receive Losartan
11299736|NCT03029091|EG002|Reported Event|EoE - CTD|Participants with eosinophilic esophagitis (EoE) without connective tissue disorder (CTD) receive Losartan
11299737|NCT03029143|BG000|Baseline|Lead-in Period: Vedolizumab 300 mg|Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2 . Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.
11299738|NCT03029143|FG000|Participant Flow|Lead-in Period: Vedolizumab 300 mg|Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.
11299739|NCT03029143|FG001|Participant Flow|Randomized Treatment Period (RTP): Standard Treatment Arm|Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.
11299740|NCT03029143|FG002|Participant Flow|RTP: Dose Optimized Arm|Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
11299741|NCT03029143|OG000|Outcome|RTP: Standard Treatment Arm|Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.
11299742|NCT03029143|OG001|Outcome|RTP: Dose Optimized Arm|Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
11299743|NCT03029143|EG000|Reported Event|Lead-in Period|Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2.
11299744|NCT03029143|EG001|Reported Event|Lead-in Failure Follow-up Period|Following Lead in Period, participants who were responders at Week 6 or had normal-to-low vedolizumab clearance at Week 5 were not eligible for randomization and received vedolizumab 300 mg IV infusion at Week 6 plus 18 weeks follow-up.
11299745|NCT03029143|EG002|Reported Event|RTP: Standard Treatment Arm|Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 [every 8 weeks (Q8W)] as standard treatment plus 18 weeks follow-up.
11299746|NCT03029143|EG003|Reported Event|RTP: VDZ Dose Optimization: Regimen A|Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 and 300 mg IV infusion once every 4 weeks up to Week 26 in regimen A plus 18 weeks follow-up.
11299747|NCT03029143|EG004|Reported Event|RTP: VDZ Dose Optimization: Regimen B|Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 followed by vedolizumab 600 mg once every 4 weeks up to Week 26 in regimen B plus 18 weeks follow-up.
11299748|NCT03029208|BG000|Baseline|Daprodustat|Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11299749|NCT03029208|BG001|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11299750|NCT03029208|BG002|Baseline|Total|Total of all reporting groups
11299751|NCT03029208|FG000|Participant Flow|Daprodustat|Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11299752|NCT03029208|FG001|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11299753|NCT03029208|OG000|Outcome|Daprodustat|Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11299754|NCT03029208|OG001|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11299755|NCT03029208|OG000|Outcome|Daprodustat 1 mg|Participants received film-coated tablets of daprodustat 1 mg orally once daily for 52 weeks.
11299756|NCT03029208|OG001|Outcome|Daprodustat 2 mg|Participants received film-coated tablets of daprodustat 2 mg orally once daily for 52 weeks.
11299757|NCT03029208|OG002|Outcome|Daprodustat 4 mg|Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
11299758|NCT03029208|OG003|Outcome|Daprodustat 6 mg|Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
11299759|NCT03029208|OG004|Outcome|Daprodustat 8 mg|Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
11299760|NCT03029208|OG005|Outcome|Daprodustat 10 mg|Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
11299761|NCT03029208|OG006|Outcome|Daprodustat 12 mg|Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
11299762|NCT03029208|OG007|Outcome|Daprodustat 16 mg|Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
11299763|NCT03029208|OG008|Outcome|Daprodustat 24 mg|Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
11299764|NCT03029208|EG000|Reported Event|Daprodustat|Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).
11299765|NCT03029208|EG001|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
11299766|NCT03029247|BG000|Baseline|Daprodustat|Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299767|NCT03029247|BG001|Baseline|Recombinant Human Erythropoietin|Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299768|NCT03029247|BG002|Baseline|Total|Total of all reporting groups
11299769|NCT03029247|FG000|Participant Flow|Daprodustat|Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299770|NCT03029247|FG001|Participant Flow|Recombinant Human Erythropoietin|Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299771|NCT03029247|OG000|Outcome|Daprodustat|Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299772|NCT03029247|OG001|Outcome|Recombinant Human Erythropoietin|Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
10971617|NCT00916058|OG000|Outcome|Dose Level 1|"Dose Level 1; Bendamustine 30 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 30 mg/m^2 given on day 2 of melphalan~Melphalan: 100 mg/m^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min)"
11299773|NCT03029247|EG000|Reported Event|Daprodustat|Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299774|NCT03029247|EG001|Reported Event|Recombinant Human Erythropoietin|Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2.
11299775|NCT03029585|BG000|Baseline|NanoPac® 100 mg/m2|"Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299776|NCT03029585|BG001|Baseline|NanoPac® 200 mg/m2|"Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299777|NCT03029585|BG002|Baseline|Total|Total of all reporting groups
11299778|NCT03029585|FG000|Participant Flow|NanoPac® 100 mg/m2|"Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299779|NCT03029585|FG001|Participant Flow|NanoPac® 200 mg/m2|"Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299780|NCT03029585|OG000|Outcome|NanoPac® 100 mg/m2|"Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299781|NCT03029585|OG001|Outcome|NanoPac® 200 mg/m2|"Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299782|NCT03029585|EG000|Reported Event|NanoPac® 100 mg/m2|"Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299783|NCT03029585|EG001|Reported Event|NanoPac® 200 mg/m2|"Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.~NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment~Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment"
11299784|NCT03029624|BG000|Baseline|eCoin|"Treatment Arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299785|NCT03029624|FG000|Participant Flow|eCoin|"Treatment arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299786|NCT03029624|OG000|Outcome|eCoin|"Treatment Arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299787|NCT03029624|OG000|Outcome|Treatment Arm|"Treatment Arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299788|NCT03029624|OG000|Outcome|eCoin|"Treatment arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299789|NCT03029624|EG000|Reported Event|eCoin|"Treatment arm receives implanted eCoin device and therapy is turned ON.~eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy."
11299790|NCT03029650|BG000|Baseline|All Study Participants|Each of the subjects received Transderm Scop® (1.5mg/72 hrs) and intravenous scopolamine hydrobromide (0.4 mg)
11299791|NCT03029650|FG000|Participant Flow|Transderm Scop®, Then IV Scopolamine Hydrbromide|Participants wore a Transderm Scop® patch (1.5 mg) for 3 days and received a single intravenous dose of 0.4 mg scopolamine hydrobromide in a crossover design with adequate washout in between.
11299792|NCT03029650|FG001|Participant Flow|IV Scopolamine HBr, Then Transderm Scop®|Participants received a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wore a Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between.
11299793|NCT03029650|OG000|Outcome|Transderm Scop®|All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
11299794|NCT03029650|OG001|Outcome|Intravenous Scopolamine Hydrobromide|All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
11299795|NCT03029650|OG000|Outcome|Intervention: IV Scopolamine Hydrobromide|"Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide~Intravenous scopolamine hydrobromide: 0.4 mg via intravenous injection"
11299796|NCT03029650|OG000|Outcome|Intravenous Scopolamine Hydrobromide|Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide
11299797|NCT03029650|OG000|Outcome|Transderm Scop®|"Each of the subjects will wear the Transderm Scop® patch (1.5 mg) for 3 days~Transderm Scop®: TDDS dosage is 1.5 mg/72 hrs"
11299798|NCT03029650|OG001|Outcome|Intravenous Scopolamine Hydrobromide|"Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide~Intravenous scopolamine hydrobromide: 0.4 mg via intravenous injection"
11299799|NCT03029650|EG000|Reported Event|Intervention: Transderm Scop® (6 Days)|"Transderm Scop® patch (1.5 mg) for 3 days with 3 days of follow up sample collection time points~Transderm Scop®: TDDS dosage is 1.5 mg/72 hrs"
11299800|NCT03029650|EG001|Reported Event|Intervention: Intravenous Scopolamine Hydrobromide (3 Days)|"0.4 mg of intravenous scopolamine hydrobromide~Intravenous scopolamine hydrobromide: 0.4 mg via intravenous injection"
11299801|NCT03029715|BG000|Baseline|Intravenous Anaesthesia|"Propofol Dexmedetomidine Remifentanil~Propofol: Total intravenous anaesthesia.~Remifentanil: Narcotics~Dexmedetomidine: Total intravenous anaesthesia"
11299802|NCT03029715|BG001|Baseline|Inhalation Anaesthesia|"Desflurane Remifentanil~Remifentanil: Narcotics~Desflurane: Inhalation anaesthesia."
11299803|NCT03029715|BG002|Baseline|Total|Total of all reporting groups
11299804|NCT03029715|FG000|Participant Flow|Intravenous Anaesthesia|"Propofol Dexmedetomidine Remifentanil~Propofol: Total intravenous anaesthesia.~Remifentanil: Narcotics~Dexmedetomidine: Total intravenous anaesthesia"
11299805|NCT03029715|FG001|Participant Flow|Inhalation Anaesthesia|"Desflurane Remifentanil~Remifentanil: Narcotics~Desflurane: Inhalation anaesthesia."
11299806|NCT03029715|OG000|Outcome|Sleeve Gastrectomy 1|"Propofol Dexmedetomidine Remifentanil~Propofol: Total intravenous anaesthesia.~Remifentanil: Narcotics~Dexmedetomidine: Total intravenous anaesthesia"
11299807|NCT03029715|OG001|Outcome|Sleeve Gastrectomy 2|"Desflurane Remifentanil~Remifentanil: Narcotics~Desflurane: Inhalation anaesthesia."
11299808|NCT03029715|EG000|Reported Event|Intravenous Anaesthesia|"Propofol Dexmedetomidine Remifentanil~Propofol: Total intravenous anaesthesia.~Remifentanil: Narcotics~Dexmedetomidine: Total intravenous anaesthesia"
11299809|NCT03029715|EG001|Reported Event|Inhalation Anaesthesia|"Desflurane Remifentanil~Remifentanil: Narcotics~Desflurane: Inhalation anaesthesia."
11299819|NCT03029819|BG000|Baseline|Mindfulness-based Addiction Treatment (MBAT)|"Nicotine patch; self-help guide; MBAT~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299820|NCT03029819|BG001|Baseline|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299821|NCT03029819|BG002|Baseline|Total|Total of all reporting groups
11299822|NCT03029819|FG000|Participant Flow|Mindfulness-based Addiction Treatment (MBAT)|"Nicotine patch; self-help guide; MBAT~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299823|NCT03029819|FG001|Participant Flow|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299824|NCT03029819|OG000|Outcome|Mindfulness-based Addiction Treatment (MBAT)|"Nicotine patch; self-help guide; MBAT~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299825|NCT03029819|OG001|Outcome|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299826|NCT03029819|OG000|Outcome|Mindfulness-based Addiction Treatment (MBAT)|"Nicotine patch; self-help guide; MBAT~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299827|NCT03029819|OG001|Outcome|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299828|NCT03029819|OG001|Outcome|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299829|NCT03029819|EG000|Reported Event|Mindfulness-based Addiction Treatment (MBAT)|"Nicotine patch; self-help guide; MBAT~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299830|NCT03029819|EG001|Reported Event|iQuit Mindfully|"Nicotine patch; self-help guide; MBAT; text messaging~Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).~iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.~Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).~Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches."
11299831|NCT03029988|BG000|Baseline|Cohort 1|"Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.~Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept~SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region."
11299832|NCT03029988|FG000|Participant Flow|Cohort 1|"Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.~Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept~SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region."
11299833|NCT03029988|OG000|Outcome|Cohort 1 - FDG PET CT|At screening, an FDG PET/CT scan was done in accordance with standard procedures
11299834|NCT03029988|OG001|Outcome|Cohort 1 - Tilmanocept SPECT/CT|"Subjects received 50 µg tilmanocept radiolabeled with 2.0 mCi Tc 99m through a single IV injection. SPECT/CT imaging of the abdominal region occurred 4-6 hours post-injection.~Note: The liver lesion visualized by FDG PET/CT was excised prior to SPECT/CT imaging."
11299835|NCT03029988|EG000|Reported Event|Cohort 1|"Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection.~Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept~SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region."
11299836|NCT03030183|BG000|Baseline|Zilucoplan (RA101495)|"Subjects will receive zilucoplan (RA101495) at the dose of 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC~Zilucoplan (RA101495): 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC"
11299837|NCT03030183|FG000|Participant Flow|Zilucoplan (RA101495)|"Subjects will receive zilucoplan (RA101495) at the dose of 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC~Zilucoplan (RA101495): 0. 3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC"
11299838|NCT03030183|OG000|Outcome|Zilucoplan (RA101495)|"Subjects will receive zilucoplan (RA101495) at the dose of 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC~Zilucoplan (RA101495): 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC"
11299839|NCT03030183|EG000|Reported Event|Zilucoplan (RA101495)|"Subjects will receive zilucoplan (RA101495) at the dose of 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC~Zilucoplan (RA101495): 0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC"
11299840|NCT03030599|BG000|Baseline|Open Label Treatment and Titration|All 201 subjects entered the Open Label Optimized Treatment and Titration Period (OL OTTP) and received at least 1 dose of study drug. During the OL OTTP (12 weeks), eligible subjects were transitioned to JZP-258 treatment based on their pre-treatment status. During the Stable Dose Period, subjects received open-label JZP-258 at the same unchanged dose that they received during the last 2 weeks of the Open Label Treatment and Titration Period.
11299841|NCT03030599|FG000|Participant Flow|Open-label JZP-258|All 201 subjects entered the Open Label Optimized Treatment and Titration Period (OL OTTP) and received at least 1 dose of study drug. During the OL OTTP (12 weeks), eligible subjects were transitioned to JZP-258 treatment based on their pre-treatment status. During the Stable Dose Period, subjects received open-label JZP-258 at the same unchanged dose that they received during the last 2 weeks of the Open Label Treatment and Titration Period.
11299842|NCT03030599|FG001|Participant Flow|JZP-258|JZP-258 at the dose taken during the last 2 weeks of the Stable Dose Period.
11299843|NCT03030599|FG002|Participant Flow|Placebo|A matching oral solution to JZP-258.
11299844|NCT03030599|OG000|Outcome|JZP-258|JZP-258 at the dose taken during the last 2 weeks of the Stable Dose Period.
11299845|NCT03030599|OG001|Outcome|Placebo|A matching oral solution to JZP-258.
11299846|NCT03030599|EG000|Reported Event|JZP-258|JZP-258 at the dose taken during the last 2 weeks of the Stable Dose Period.
11299847|NCT03030599|EG001|Reported Event|Placebo|A matching oral solution to JZP-258.
11299848|NCT03030638|BG000|Baseline|Olodaterol - PHARMO Overall|Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299849|NCT03030638|BG001|Baseline|Indacaterol - PHARMO Overall|Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
10971618|NCT00916058|OG001|Outcome|Dose Level 2|"Dose Level 2; Bendamustine 60 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m^2 given on the 2nd day of melphalan"
10971619|NCT00916058|OG002|Outcome|Dose Level 3|"Dose Level 3; Bendamustine 90 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m^2 given on the 2nd day of melphalan"
10971620|NCT00916058|OG003|Outcome|Dose Level 4|"Dose Level 4; Bendamustine 120 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m^2 given on the 1st and 2nd day of melphalan"
11299850|NCT03030638|BG002|Baseline|Olodaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299851|NCT03030638|BG003|Baseline|Indacaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299852|NCT03030638|BG004|Baseline|Olodaterol - IMS RWE LPD General Practitioner (GP) Panel|Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299853|NCT03030638|BG005|Baseline|Indacaterol - IMS RWE LPD GP Panel|Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299854|NCT03030638|BG006|Baseline|Olodaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299855|NCT03030638|BG007|Baseline|Indacaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299856|NCT03030638|BG008|Baseline|Total|Total of all reporting groups
11299857|NCT03030638|FG000|Participant Flow|Olodaterol - PHARMO Overall|Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299858|NCT03030638|FG001|Participant Flow|Indacaterol - PHARMO Overall|Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299859|NCT03030638|FG002|Participant Flow|Olodaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299860|NCT03030638|FG003|Participant Flow|Indacaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299861|NCT03030638|FG004|Participant Flow|Olodaterol - IMS RWE LPD General Practitioner (GP) Panel|Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299862|NCT03030638|FG005|Participant Flow|Indacaterol - IMS RWE LPD GP Panel|Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299863|NCT03030638|FG006|Participant Flow|Olodaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299864|NCT03030638|FG007|Participant Flow|Indacaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299865|NCT03030638|OG000|Outcome|Olodaterol - PHARMO Overall|Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299866|NCT03030638|OG001|Outcome|Olodaterol - PHARMO-GP|Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299867|NCT03030638|OG002|Outcome|Olodaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299868|NCT03030638|OG003|Outcome|Olodaterol - IMS RWE LPD General Practitioner (GP) Panel|Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299869|NCT03030638|OG004|Outcome|Olodaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299870|NCT03030638|OG000|Outcome|Indacaterol - PHARMO Overall|Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299871|NCT03030638|OG001|Outcome|Indacaterol - PHARMO-GP|Patients from the data source PHARMO-GP received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299872|NCT03030638|OG002|Outcome|Indacaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299873|NCT03030638|OG003|Outcome|Indacaterol - IMS RWE LPD GP Panel|Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299874|NCT03030638|OG004|Outcome|Indacaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299875|NCT03030638|OG001|Outcome|Indacaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299876|NCT03030638|OG002|Outcome|Indacaterol - IMS RWE LPD GP Panel|Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299877|NCT03030638|OG003|Outcome|Indacaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
11299878|NCT03030638|OG001|Outcome|Olodaterol - National Health Databases, Denmark|Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299879|NCT03030638|OG002|Outcome|Olodaterol - IMS RWE LPD General Practitioner (GP) Panel|Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299880|NCT03030638|OG003|Outcome|Olodaterol - IMS RWE LPD Pulmonologist Panel|Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
11299881|NCT03030638|EG000|Reported Event|Olodaterol|Patients initiating Olodaterol for the first time
11299882|NCT03030638|EG001|Reported Event|Indacaterol|Patients initiating Indacaterol for the first time
11299883|NCT03030989|BG000|Baseline|Chlorhexidine Gluconate 2% Wipe|Chlorhexidine Gluconate 2% Wipe
11299884|NCT03030989|BG001|Baseline|Placebo Wipe|Placebo Wipe
11299885|NCT03030989|BG002|Baseline|Total|Total of all reporting groups
11299886|NCT03030989|FG000|Participant Flow|Chlorhexidine Gluconate 2% Wipe|Chlorhexidine Gluconate 2% Wipe
11299887|NCT03030989|FG001|Participant Flow|Placebo Wipe|Placebo Wipe
11299888|NCT03030989|OG000|Outcome|Chlorhexidine Gluconate 2% Wipe|Chlorhexidine Gluconate 2% Wipe
11299889|NCT03030989|OG001|Outcome|Placebo Wipe|Placebo Wipe
11299890|NCT03030989|EG000|Reported Event|Chlorhexidine Gluconate 2% Wipe|Chlorhexidine Gluconate 2% Wipe
11299891|NCT03030989|EG001|Reported Event|Placebo Wipe|Placebo Wipe
11299892|NCT03031431|BG000|Baseline|Non-Electric Infant Warmer|In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
10822254|NCT00075582|OG001|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Group III patients with orbit primary receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
11299893|NCT03031431|FG000|Participant Flow|Non-Electric Infant Warmer|In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
11299894|NCT03031431|OG000|Outcome|Non-Electric Infant Warmer|In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
11299895|NCT03031431|EG000|Reported Event|Non-Electric Infant Warmer|In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
11299896|NCT03031496|BG000|Baseline|All Subjects|Participants received a single oral dose of hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination (either test or reference product) in each of the two treatment periods, separated by a wash out period of seven calendar days.
11299897|NCT03031496|FG000|Participant Flow|Treatment A Followed by Treatment B|Eligible participants received a single oral dose of GSK3542503 (BIDURET), hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination in Treatment Period 1. It was followed by a wash out period of 7 to 14 days. Participants received a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination in Treatment Period 2
11299898|NCT03031496|FG001|Participant Flow|Treatment B Followed by Treatment A|Eligible participants received a single dose of moduretic, hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination in Treatment Period 1. It was followed by a wash out period of 7 to 14 days. Participants received a single oral dose of GSK3542503 (BIDURET), hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination in Treatment Period 2.
11299899|NCT03031496|OG000|Outcome|Treatment A|Participants received a single oral dose of hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination test product in each of the two treatment periods.
11299900|NCT03031496|OG001|Outcome|Treatment B|Participants received a single oral dose of hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination reference product in each of the two treatment periods
11299901|NCT03031496|EG000|Reported Event|Treatment A|Participants received a single oral dose of hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination test product in each of the two treatment periods.
11299902|NCT03031496|EG001|Reported Event|Treatment B|Participants received a single oral dose of hydrochlorothiazide 50 milligrams (mg) and amiloride hydrochloride 5 mg fixed dose combination reference product in each of the two treatment periods
11299903|NCT03031678|BG000|Baseline|Study Procedures|Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
11299904|NCT03031678|FG000|Participant Flow|Study Procedures|Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
11299905|NCT03031678|OG000|Outcome|Electric Acoustic Stimulation|Subjects tested with a combination of electric and acoustic stimulation
11299906|NCT03031678|OG001|Outcome|CI Alone|Subjects testing with electric stimulation only
11299907|NCT03031678|OG000|Outcome|Study Procedures|Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
11299908|NCT03031678|OG000|Outcome|Electric Acoustic Stimulation|Subjects tested with electric and acoustic stimulation combined
11299909|NCT03031678|OG001|Outcome|CI Alone|Subjects tested with electric stimulation only
11299910|NCT03031678|EG000|Reported Event|Study Procedures|Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
11299911|NCT03031795|BG000|Baseline|Ketorolac|Experimental group
11299912|NCT03031795|BG001|Baseline|Placebo|Control group
11299913|NCT03031795|BG002|Baseline|Total|Total of all reporting groups
11299914|NCT03031795|FG000|Participant Flow|Experimental|"ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement~Ketorolac: Oral Tablet"
11299915|NCT03031795|FG001|Participant Flow|Placebo|"look alike placebo~Placebos"
10971621|NCT00916058|OG004|Outcome|Dose Level 5|"Dose Level 5; Bendamustine 150 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m^2 given on the 1st day of melphalan and 60 mg/m^2 given on the 2nd day of melphalan"
11299916|NCT03031795|OG000|Outcome|Ketorolac|Experimental group
11299917|NCT03031795|OG001|Outcome|Placebo|Placebo group
11299918|NCT03031795|EG000|Reported Event|Experimental|"ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement~Ketorolac: Oral Tablet"
11299919|NCT03031795|EG001|Reported Event|Placebo|"look alike placebo~Placebos"
11299920|NCT03031899|BG000|Baseline|All Study Participants|All study participants received Rose Bengal and Toulidine Blue. Patients were asked to rinse their mouth with distilled water for 1 minute. 1% RB solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse their mouth for 1 minute with distilled water to remove excess RB solution and the area which had taken up the stain was photographed. Following this, patients were asked to rinse their mouth with 1% acetic acid for 1 min to remove the remaining RB stain from the lesion and were prepared for TB staining. 1% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed.
11299921|NCT03031899|FG000|Participant Flow|All Study Participants|All patients received Rose Bengal and Toluidine Blue. Initially patients were asked to rinse their mouth with distilled water for 1 minute. 1% RB solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse their mouth for 1 minute with distilled water to remove excess RB solution and the area which had taken up the stain was photographed. Following this, patients were asked to rinse their mouth with 1% acetic acid for 1 min to remove the remaining RB stain from the lesion and were prepared for TB staining. 1% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed.
11299922|NCT03031899|OG000|Outcome|Rose Bengal Staining|Initially patients were asked to rinse their mouth with distilled water for 1 minute. 1% RB solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse their mouth for 1 minute with distilled water to remove excess RB solution and the area which had taken up the stain was photographed. positively stained lesions were subjected for biopsy.
11299923|NCT03031899|OG001|Outcome|Toluidine Blue Staining|Following RB staining, patients were asked to rinse their mouth with 1% acetic acid for 1 min to remove the remaining RB stain from the lesion and were prepared for TB staining. 1% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed. positively stained lesions were subjected to biopsy.
11299924|NCT03031899|OG000|Outcome|All Study Participants|"1% RB solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse their mouth for 1 minute with distilled water to remove excess RB solution and the area which had taken up the stain was photographed.8 Following this, patients were asked to rinse their mouth with 1% acetic acid for 1 min to remove the remaining RB stain from the lesion.~1% toluidine blue applied over the lesion and after 30 seconds were made to swish with 1% acetic acid. the area retaining the stain was photographed and compared with that of rose bengal. only positively stained areas were subjected to biopsy procedure."
11299925|NCT03031899|OG000|Outcome|Rose Bengal Staining and Biopsy|Patients were asked to rinse their mouth with distilled water for 1 minute. 1% RB solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse their mouth for 1 minute with distilled water to remove excess RB solution and the area which had taken up the stain was photographed. Positively stained lesions were biopsied.
11299926|NCT03031899|EG000|Reported Event|Rose Bengal Positive Lesion|lesions were subjected to rose bengal staining and positive lesions were subjected to biopsy
11299927|NCT03031899|EG001|Reported Event|Toluidine Blue Positive Lesions and Biopsy|lesions were subjected to toluidine blue staining and positive lesions were subjected to biopsy
11299928|NCT03031938|BG000|Baseline|Maternal Exposure to Tanezumab|Infants in this reporting arm were those who had potential maternal exposure to tanezumab.
11299929|NCT03031938|BG001|Baseline|Maternal Exposure to Tramadol|Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
11299930|NCT03031938|BG002|Baseline|Total|Total of all reporting groups
11299931|NCT03031938|FG000|Participant Flow|Maternal Exposure to Tanezumab|Infants in this reporting arm were those who had potential maternal exposure to tanezumab.
11299932|NCT03031938|FG001|Participant Flow|Maternal Exposure to Tramadol|Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
11299933|NCT03031938|OG000|Outcome|Maternal Exposure to Tanezumab|Infants in this reporting arm were those who had potential maternal exposure to tanezumab.
11299934|NCT03031938|OG001|Outcome|Maternal Exposure to Tramadol|Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
11299935|NCT03031938|EG000|Reported Event|Maternal Exposure to Tanezumab|Infants in this reporting arm were those who had potential maternal exposure to tanezumab.
11299936|NCT03031938|EG001|Reported Event|Maternal Exposure to Tramadol|Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
11299937|NCT03032263|BG000|Baseline|Direct Laryngoscopy|"These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy"
11299938|NCT03032263|BG001|Baseline|Video Laryngoscopy|"These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure."
11299939|NCT03032263|BG002|Baseline|Total|Total of all reporting groups
11299940|NCT03032263|FG000|Participant Flow|Direct Laryngoscopy|"These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy"
11299941|NCT03032263|FG001|Participant Flow|Video Laryngoscopy|"These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure."
11299942|NCT03032263|OG000|Outcome|Direct Laryngoscopy|"These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy"
11299943|NCT03032263|OG001|Outcome|Video Laryngoscopy|"These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure."
11299944|NCT03032263|EG000|Reported Event|Direct Laryngoscopy|"These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy"
11299945|NCT03032263|EG001|Reported Event|Video Laryngoscopy|"These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.~Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure."
11299946|NCT03032380|BG000|Baseline|Cefiderocol|Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299947|NCT03032380|BG001|Baseline|Meropenem|Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299948|NCT03032380|BG002|Baseline|Total|Total of all reporting groups
11299949|NCT03032380|FG000|Participant Flow|Cefiderocol|Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299950|NCT03032380|FG001|Participant Flow|Meropenem|Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299951|NCT03032380|OG000|Outcome|Cefiderocol|Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299952|NCT03032380|OG001|Outcome|Meropenem|Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299953|NCT03032380|EG000|Reported Event|Cefiderocol|Participants received 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299954|NCT03032380|EG001|Reported Event|Meropenem|Participants received 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
11299955|NCT03032393|BG000|Baseline|Dominant|high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
11299956|NCT03032393|BG001|Baseline|Submissive|low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
11299957|NCT03032393|BG002|Baseline|Total|Total of all reporting groups
11299958|NCT03032393|FG000|Participant Flow|Dominant|high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
11299959|NCT03032393|FG001|Participant Flow|Submissive|low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
11299960|NCT03032393|OG000|Outcome|Dominant|high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
11299961|NCT03032393|OG001|Outcome|Submissive|low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
11299962|NCT03032393|EG000|Reported Event|Dominant|high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
11299963|NCT03032393|EG001|Reported Event|Submissive|low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
11299964|NCT03032523|BG000|Baseline|Remote Monitoring CGM Group|"Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.~Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dL, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar."
11299965|NCT03032523|BG001|Baseline|Blinded CGM Group|Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
11299966|NCT03032523|BG002|Baseline|Total|Total of all reporting groups
11299967|NCT03032523|FG000|Participant Flow|Remote Monitoring CGM Group|"Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.~Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar."
11299968|NCT03032523|FG001|Participant Flow|Blinded CGM Group|Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
11299969|NCT03032523|OG000|Outcome|Remote Monitoring CGM Group|"Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.~Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar."
11299970|NCT03032523|OG001|Outcome|Blinded CGM Group|Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
11299971|NCT03032523|OG000|Outcome|Remote Monitoring CGM Group|"Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.~Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar."
11299972|NCT03032523|EG000|Reported Event|Remote Monitoring CGM Group|"Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 45 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.~Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar."
11299973|NCT03032523|EG001|Reported Event|Blinded CGM Group|Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
11299974|NCT03032965|BG000|Baseline|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299975|NCT03032965|BG001|Baseline|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299976|NCT03032965|BG002|Baseline|Total|Total of all reporting groups
11299977|NCT03032965|FG000|Participant Flow|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299978|NCT03032965|FG001|Participant Flow|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299979|NCT03032965|OG000|Outcome|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299980|NCT03032965|OG001|Outcome|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299981|NCT03032965|EG000|Reported Event|Adenosine and Isoproterenol|"Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.~Adenosine: Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299982|NCT03032965|EG001|Reported Event|Isoproterenol|"This group will not receive adenosine during the procedure.~Isoproterenol: Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol."
11299983|NCT03033108|BG000|Baseline|Emixustat Dose 1|"lowest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299984|NCT03033108|BG001|Baseline|Emixustat Dose 2|"middle dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299985|NCT03033108|BG002|Baseline|Emixustat Dose 3|"highest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299986|NCT03033108|BG003|Baseline|Total|Total of all reporting groups
11299987|NCT03033108|FG000|Participant Flow|Emixustat Dose 1|"lowest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299988|NCT03033108|FG001|Participant Flow|Emixustat Dose 2|"middle dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299989|NCT03033108|FG002|Participant Flow|Emixustat Dose 3|"highest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299990|NCT03033108|OG000|Outcome|Emixustat Dose 1|"lowest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299991|NCT03033108|OG001|Outcome|Emixustat Dose 2|"middle dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299992|NCT03033108|OG002|Outcome|Emixustat Dose 3|"highest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299993|NCT03033108|EG000|Reported Event|Emixustat Dose 1|"lowest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299994|NCT03033108|EG001|Reported Event|Emixustat Dose 2|"middle dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299995|NCT03033108|EG002|Reported Event|Emixustat Dose 3|"highest dose of once-daily oral emixustat~Emixustat: Once daily, tablet for oral administration"
11299996|NCT03033134|BG000|Baseline|Implant (ITT)|Implant (ITT) group: 42 subjects
11299997|NCT03033134|BG001|Baseline|Roll-in|Roll-in group: 12 subjects
11299998|NCT03033134|BG002|Baseline|Total|Total of all reporting groups
11299999|NCT03033134|FG000|Participant Flow|Implant (ITT)|BSJ003W implant group (ITT) : 42 subjects
11300000|NCT03033134|FG001|Participant Flow|Roll-in|12 Roll-in subjects
11300001|NCT03033134|OG000|Outcome|Implant (ITT)|Implant (ITT) group: 42 subjects
11300002|NCT03033134|OG001|Outcome|Roll-in|Roll-in cohort
11300003|NCT03033134|OG001|Outcome|Roll-in|Roll-in cohort: 12 subjects
11300004|NCT03033134|OG000|Outcome|Implant (ITT)|Implant (ITT): 42 subjects
11300005|NCT03033134|EG000|Reported Event|Implant (ITT)|Implant (ITT) group: 42 subjects
11300006|NCT03033134|EG001|Reported Event|Roll-in|Roll-in cohort: 12 subjects
11300007|NCT03033394|BG000|Baseline|Beta-lactam Antibiotic|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300008|NCT03033394|FG000|Participant Flow|Beta-lactam Antibiotic|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300009|NCT03033394|OG000|Outcome|Amoxicillin|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300010|NCT03033394|OG001|Outcome|Co-amoxiclav|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300011|NCT03033394|OG002|Outcome|Ceftriaxone|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300012|NCT03033394|OG003|Outcome|Flucloxacillin|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300013|NCT03033394|OG004|Outcome|Meropenem|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300014|NCT03033394|OG005|Outcome|Piperacillin-tazobactam|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300015|NCT03033394|EG000|Reported Event|Beta-lactam Antibiotic|"Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.~Beta-lactam antibiotic: Routine clinical dosing"
11300016|NCT03033511|BG000|Baseline|Placebo|"Placebo every 6 weeks (q6 wk); omitting every third cycle~Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300017|NCT03033511|BG001|Baseline|Rovalpituzumab Tesirine/Dexamethasone|"Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle~Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300018|NCT03033511|BG002|Baseline|Total|Total of all reporting groups
11300019|NCT03033511|FG000|Participant Flow|Placebo|"Placebo every 6 weeks (q6 wk); omitting every third cycle~Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300020|NCT03033511|FG001|Participant Flow|Rovalpituzumab Tesirine/Dexamethasone|"Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle~Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300021|NCT03033511|OG000|Outcome|Placebo|"Placebo every 6 weeks (q6 wk); omitting every third cycle~Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300022|NCT03033511|OG001|Outcome|Rovalpituzumab Tesirine/Dexamethasone|"Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle~Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300023|NCT03033511|EG000|Reported Event|Placebo|"Placebo q6 wk; omitting every third cycle~Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300024|NCT03033511|EG001|Reported Event|Rovalpituzumab Tesirine/Dexamethasone|"Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle~Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle"
11300025|NCT03033745|BG000|Baseline|IgPro20 (Pump-Assisted Volume Cohort)|"Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300026|NCT03033745|BG001|Baseline|IgPro20 (Pump Assisted Flow Rate Cohort)|"Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300027|NCT03033745|BG002|Baseline|IgPro20 (Manual Push Flow Rate Cohort)|"Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300028|NCT03033745|BG003|Baseline|Total|Total of all reporting groups
11300029|NCT03033745|FG000|Participant Flow|IgPro20 (Pump-Assisted Volume Cohort)|"Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300030|NCT03033745|FG001|Participant Flow|IgPro20 (Pump Assisted Flow Rate Cohort)|"Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300031|NCT03033745|FG002|Participant Flow|IgPro20 (Manual Push Flow Rate Cohort)|"Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300032|NCT03033745|OG000|Outcome|IgPro20 (Pump-Assisted Volume Cohort)|"Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300033|NCT03033745|OG001|Outcome|IgPro20 (Pump Assisted Flow Rate Cohort)|"Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300034|NCT03033745|OG002|Outcome|IgPro20 (Manual Push Flow Rate Cohort)|"Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.~IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry."
11300035|NCT03033745|EG000|Reported Event|IgPro20 (Pump-assisted Volume) 25 mL|Volumes per injection site of 25 mL administered subcutaneously.
11300036|NCT03033745|EG001|Reported Event|IgPro20 (Pump-assisted Volume) 40 mL|Volumes per injection site of 40 mL administered subcutaneously.
11300037|NCT03033745|EG002|Reported Event|IgPro20 (Pump-assisted Volume) 50 mL|Volumes per injection site of 50 mL administered subcutaneously.
11300038|NCT03033745|EG003|Reported Event|IgPro20 (Pump-assisted Flow Rate) 25 mL/h|Flow rates per injection site of 25 mL/hour administered subcutaneously.
11300039|NCT03033745|EG004|Reported Event|IgPro20 (Pump-assisted Flow Rate) 50 mL/h|Flow rates per injection site of 50 mL/hour administered subcutaneously.
11300040|NCT03033745|EG005|Reported Event|IgPro20 (Pump-assisted Flow Rate) 75 mL/h|Flow rates per injection site of 75 mL/hour administered subcutaneously.
11300041|NCT03033745|EG006|Reported Event|IgPro20 (Pump-assisted Flow Rate) 100 mL/h|Flow rates per injection site of 100 mL/hour administered subcutaneously.
11300042|NCT03033745|EG007|Reported Event|IgPro20 (Manual Push Flow Rate) 30 mL/h|Flow rates per injection site of approximately 30 mL/hour administered subcutaneously.
11300043|NCT03033745|EG008|Reported Event|IgPro20 (Manual Push Flow Rate) 60 mL/h|Flow rates per injection site of approximately 60 mL/hour administered subcutaneously.
11300044|NCT03033745|EG009|Reported Event|IgPro20 (Manual Push Flow Rate) 120 mL/h|Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.
11300045|NCT03033784|BG000|Baseline|Autism Spectrum Disorder (ASD)|Male participants diagnosed with ASD received 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) or a placebo during 4 study visits. The order in which the participant received the placebo and three different doses of oxytocin (8, 24, or 48IU) was randomly assigned.
11300046|NCT03033784|BG001|Baseline|Healthy Control|Age matched healthy males received a placebo intranasal spray (12 puffs, 6 per nostril) during one study visit
11300047|NCT03033784|BG002|Baseline|Total|Total of all reporting groups
11300048|NCT03033784|FG000|Participant Flow|Dose Order: Placebo, 8 International Units (IU), 24IU, 48IU|Participants with ASD randomized to receive the placebo first, followed by an 8IU of oxytocin, then 24IU dose of oxytocin, and a 48IU dose of oxytocin last.
11300049|NCT03033784|FG001|Participant Flow|Dose Order: 24IU, 8IU, Placebo, 48IU|Participants with ASD randomized to receive a 24IU dose of oxytocin, followed by an 8IU of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
11300050|NCT03033784|FG002|Participant Flow|Dose Order: 24IU, Placebo, 8IU, 48IU|Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by the placebo, then 8IU dose of oxytocin, and a 48IU dose of oxytocin last.
11300051|NCT03033784|FG003|Participant Flow|Dose Order: 48IU, Placebo, 8IU, 24IU|Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by the placebo, then an 8IU dose of oxytocin, and a 24IU dose of oxytocin last.
11300052|NCT03033784|FG004|Participant Flow|Dose Order: 8IU, 24IU, Placebo, 48IU|Participants with ASD randomized to receive an 8IU dose of oxytocin first, followed by a 24IU dose of oxytocin, then the placebo, and a 48IU dose of oxytocin last.
11300053|NCT03033784|FG005|Participant Flow|Dose Order: 48IU, 24IU, 8IU, Placebo|Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by a 24IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
11300054|NCT03033784|FG006|Participant Flow|Dose Order: Placebo, 48IU, 24IU, 8IU|Participants with ASD randomized to receive the placebo first, followed by a 48IU of oxytocin, then 24IU dose of oxytocin, and an 8IU dose of oxytocin last.
11300055|NCT03033784|FG007|Participant Flow|Dose Order: Placebo, 24IU, 48IU, 8IU|Participants with ASD randomized to receive the placebo first, followed by a 24IU of oxytocin, then a 48IU dose of oxytocin, and an 8IU dose of oxytocin last.
11300056|NCT03033784|FG008|Participant Flow|Dose Order: 48IU, 24IU, Placebo, 8IU|Participants with ASD randomized to receive a dose of 48IU of oxytocin first, followed by a 24IU of oxytocin, then the placebo, and an 8IU dose of oxytocin last.
11300057|NCT03033784|FG009|Participant Flow|Dose Order: 8IU, 24IU, 48IU, Placebo|Participants with ASD randomized to receive an 8IU of oxytocin first, followed by an 24IU of oxytocin, then 48IU dose of oxytocin, the placebo last.
11300058|NCT03033784|FG010|Participant Flow|Dose Order: 24IU, 48IU, 8IU, Placebo|Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by a 48IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.
11300059|NCT03033784|FG011|Participant Flow|Dose Order: 48IU, 8IU, Placebo, 24IU|Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by an 8IU of oxytocin, then the placebo, and a 24IU dose of oxytocin last.
11300060|NCT03033784|FG012|Participant Flow|Healthy Controls Receiving the Placebo|Healthy controls (persons without ASD) received the placebo rather than any oxytocin. The healthy controls only attended one clinical visit, per the study protocol.
11300061|NCT03033784|OG000|Outcome|Placebo in ASD Participants|Participants receiving the placebo
11300062|NCT03033784|OG001|Outcome|8IU of Oxytocin Spray|Participants receiving 8IU of oxytocin
11300063|NCT03033784|OG002|Outcome|24IU of Oxytocin Spray|Participants receiving 24IU of oxytocin
11300064|NCT03033784|OG003|Outcome|48IU of Oxytocin Spray|Participants receiving 48IU of oxytocin
11300065|NCT03033784|OG004|Outcome|Healthy Controls Receiving Placebo|Healthy controls received the placebo spray only
11300066|NCT03033784|EG000|Reported Event|Placebo|Participants receiving the placebo
11300067|NCT03033784|EG001|Reported Event|8IU of Oxytocin Spray|Participants receiving 8IU of oxytocin
11300068|NCT03033784|EG002|Reported Event|24IU of Oxytocin Spray|Participants receiving 24IU of oxytocin
11300069|NCT03033784|EG003|Reported Event|48IU of Oxytocin Spray|Participants receiving 48IU of oxytocin
11300070|NCT03034044|BG000|Baseline|Xyntha|Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
11300071|NCT03034044|FG000|Participant Flow|Xyntha|Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
11300072|NCT03034044|OG000|Outcome|Xyntha|Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
11300073|NCT03034044|EG000|Reported Event|Xyntha|Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
11300074|NCT03034057|BG000|Baseline|Sayana Press|Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
11300075|NCT03034057|FG000|Participant Flow|Sayana Press|Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
11300076|NCT03034057|OG000|Outcome|Sayana Press|Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
11300077|NCT03034057|EG000|Reported Event|Sayana Press|Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.
11300078|NCT03034135|BG000|Baseline|Disulfiram and Copper Gluconate|"Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.~Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.~Temozolomide (TMZ): TMZ is given per standard of care"
11300079|NCT03034135|FG000|Participant Flow|DSF-Cu|"Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.~Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.~Temozolomide (TMZ): TMZ is given per standard of care"
11300080|NCT03034135|OG000|Outcome|DSF-Cu|"Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.~Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.~Temozolomide (TMZ): TMZ is given per standard of care"
11300081|NCT03034135|EG000|Reported Event|Group A|Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ.
11300082|NCT03034460|BG000|Baseline|Group I: CD5024 Cream Versus Its Vehicle|Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300083|NCT03034460|BG001|Baseline|Group II: Epiduo Gel Versus Its Vehicle|Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300084|NCT03034460|BG002|Baseline|Total|Total of all reporting groups
11300085|NCT03034460|FG000|Participant Flow|Group I: CD5024 Cream Versus Its Vehicle|Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300086|NCT03034460|FG001|Participant Flow|Group II: Epiduo Gel Versus Its Vehicle|Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300087|NCT03034460|OG000|Outcome|CD5024 1% Cream|Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
11300088|NCT03034460|OG001|Outcome|CD5024 1% Cream Matched Placebo|Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
11300089|NCT03034460|OG002|Outcome|Adapalene Benzoyl Peroxyde|Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
11300090|NCT03034460|OG003|Outcome|Adapalene Benzoyl Peroxyde Matched Placebo|"Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week~1 to Week 5 and for 4 days during Week 6."
11300091|NCT03034460|OG000|Outcome|Group I: CD5024 Cream Versus Its Vehicle|Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300092|NCT03034460|OG001|Outcome|Group II: Epiduo Gel Versus Its Vehicle|Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300093|NCT03034460|EG000|Reported Event|Group I: CD5024 Cream Versus Its Vehicle|Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300094|NCT03034460|EG001|Reported Event|Group II: Epiduo Gel Versus Its Vehicle|Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
11300095|NCT03034577|BG000|Baseline|Moderate Neuromuscular Blockade Reversed With Neostigmine|"The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF > 2.~Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.~Extubation occurred when the TOF = 4 with no visible fade."
11300096|NCT03034577|BG001|Baseline|Deep Neuromuscular Blockade Reversed With Sugammadex|"The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.~Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.~Extubation occurred when the TOF=4 with no visible fade."
11300097|NCT03034577|BG002|Baseline|Total|Total of all reporting groups
11300098|NCT03034577|FG000|Participant Flow|Moderate Neuromuscular Blockade Reversed With Neostigmine|"The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF > 2.~Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.~Extubation occurred when the TOF = 4 with no visible fade."
11300099|NCT03034577|FG001|Participant Flow|Deep Neuromuscular Blockade Reversed With Sugammadex|"The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.~Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.~Extubation occurred when the TOF=4 with no visible fade."
11300100|NCT03034577|OG000|Outcome|Moderate Neuromuscular Blockade Reversed With Neostigmine|"The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF > 2.~Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.~Extubation occurred when the TOF = 4 with no visible fade."
11300101|NCT03034577|OG001|Outcome|Deep Neuromuscular Blockade Reversed With Sugammadex|"The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.~Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.~Extubation occurred when the TOF=4 with no visible fade."
11300102|NCT03034577|OG000|Outcome|Moderate Neuromuscular Blockade Reversed With Neostigmine|"Moderate Neuromuscular block: participants will receive moderate neuromuscular blockade with rocuronium aiming for TOF 0-2 twitches, with neostigmine reversal when the TOF at least 3 twitches. The depth of neuromuscular block may be reduced after completion of the majority of surgical excision to TOF 3 or more~Neostigmine~Neostigmine: Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present."
11300103|NCT03034577|OG001|Outcome|Deep Neuromuscular Blockade Reversed With Sugammadex|"Deep Neuromuscular block: participants will receive DNB aiming for a post tetanic count of 1-2, which will be maintained until removal of the laparoscopic ports, with reversal using sugammadex~Sugammadex: Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1."
11300104|NCT03034577|EG000|Reported Event|Moderate Neuromuscular Blockade Reversed With Neostigmine|"The initial dosage of a moderate block was 0.6mg/kg of rocuronium, with repeat dosage of 0.15mg/kg given if the TOF > 2.~Once the TOF had 2 twitches, 50mcg/kg Neostigmine coupled with 20mcg/kg of atropine or 5mcg/kg of glycopyrrolate was administered for the reversal of a moderate block with a maximum dosage of 5.0mg of neostigmine.~Extubation occurred when the TOF = 4 with no visible fade."
11300105|NCT03034577|EG001|Reported Event|Deep Neuromuscular Blockade Reversed With Sugammadex|"The initial dosage of deep block was 1.2mg/kg with repeat dosages of 0.15mg/kg until PTC ≤ 2.~Sugammadex dosage was adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. The dosage was 4mg/kg when TOF=0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.~Extubation occurred when the TOF=4 with no visible fade."
11300106|NCT03034772|BG000|Baseline|Dorzolamide-timolol|"Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration"
11300107|NCT03034772|BG001|Baseline|Artificial Tears|"Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration"
11300108|NCT03034772|BG002|Baseline|Total|Total of all reporting groups
11300109|NCT03034772|FG000|Participant Flow|Dorzolamide-timolol|"Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration"
11300110|NCT03034772|FG001|Participant Flow|Artificial Tears|"Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration"
11300111|NCT03034772|OG000|Outcome|Dorzolamide-timolol|"Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration"
11300112|NCT03034772|OG001|Outcome|Artificial Tears|"Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration"
11300113|NCT03034772|EG000|Reported Event|Dorzolamide-timolol|"Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Dorzolamide-timolol: Topical eye drop (active comparator) used twice daily for study duration"
11300114|NCT03034772|EG001|Reported Event|Artificial Tears|"Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.~Artificial tears: Topical eye drop (placebo comparator) used twice daily for study duration"
11300115|NCT03034915|BG000|Baseline|UMEC/VI 62.5/25 mcg+ Placebo|Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300116|NCT03034915|BG001|Baseline|UMEC 62.5 mcg + Placebo|Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300117|NCT03034915|BG002|Baseline|Salmeterol 50 mcg+Placebo|Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300118|NCT03034915|BG003|Baseline|Total|Total of all reporting groups
11300119|NCT03034915|FG000|Participant Flow|UMEC/VI 62.5/25 mcg+ Placebo|Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300120|NCT03034915|FG001|Participant Flow|UMEC 62.5 mcg + Placebo|Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300121|NCT03034915|FG002|Participant Flow|Salmeterol 50 mcg+Placebo|Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300122|NCT03034915|OG000|Outcome|UMEC/VI 62.5/25 mcg+ Placebo|Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300123|NCT03034915|OG001|Outcome|UMEC 62.5 mcg + Placebo|Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300124|NCT03034915|OG002|Outcome|Salmeterol 50 mcg+Placebo|Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300125|NCT03034915|EG000|Reported Event|UMEC/VI 62.5/25 mcg+ Placebo|Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300126|NCT03034915|EG001|Reported Event|UMEC 62.5 mcg + Placebo|Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300127|NCT03034915|EG002|Reported Event|Salmeterol 50 mcg+Placebo|Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
11300128|NCT03034928|BG000|Baseline|Overall|Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2.
11300129|NCT03034928|FG000|Participant Flow|Test 1/Control 1, Then Control 2/Test 2|Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
11300130|NCT03034928|FG001|Participant Flow|Test 2/Control 2, Then Control 1/Test 1|Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
11300131|NCT03034928|FG002|Participant Flow|Control 1/Test 1, Then Test 2/Control 2|Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
11300132|NCT03034928|FG003|Participant Flow|Control 2/Test 2, Then Test 1/Control 1|Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
11300133|NCT03034928|OG000|Outcome|Test 1|Contact lens with investigational coating 1 worn for approximately 2 hours during Period 1 or Period 2
10971622|NCT00916058|OG005|Outcome|Dose Level 6|"Dose Level 6; Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan"
10971623|NCT00916058|OG000|Outcome|Phase 2|"Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan"
10971624|NCT00916058|OG000|Outcome|Phase 1|"Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min).~Dose Level 1; Bendamustine 30 mg/m^2 total Dose Level 2; Bendamustine 60 mg/m^2 total Dose Level 3; Bendamustine 90 mg/m^2 total Dose Level 4; Bendamustine 120 mg/m^2 total Dose Level 5; Bendamustine 150 mg/m^2 total Dose Level 6; Bendamustine 225 mg/m^2 total"
10971625|NCT00916058|OG000|Outcome|Phase 2|Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)
11300134|NCT03034928|OG001|Outcome|Control 1|Balafilcon A contact lens worn contralaterally to Test 1 for approximately 2 hours during Period 1 or Period 2
11300135|NCT03034928|OG002|Outcome|Test 2|Contact lens with investigational coating 2 worn for approximately 2 hours during Period 1 or Period 2
11300136|NCT03034928|OG003|Outcome|Control 2|Balafilcon A contact lens worn contralaterally to Test 2 for approximately 2 hours during Period 1 or Period 2
11300137|NCT03034928|EG000|Reported Event|Test 1|All subjects exposed to contact lens with investigational coating 1 during Period 1 or Period 2
11300138|NCT03034928|EG001|Reported Event|Test 2|All subjects exposed to contact lens with investigational coating 2 during Period 1 or Period 2
11300139|NCT03034928|EG002|Reported Event|Control|All subjects exposed to balafilcon A contact lens during Period 1 or Period 2
11300140|NCT03034954|BG000|Baseline|Active HD-tDCS|"Participants will receive real HD-tDCS (3 milliamps for 20 minutes) for a single session.~Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes"
11300141|NCT03034954|BG001|Baseline|Sham HD-tDCS|"Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.~Sham HD-tDCS: Participants will receive sham HD-tDCS"
11300142|NCT03034954|BG002|Baseline|Total|Total of all reporting groups
11300143|NCT03034954|FG000|Participant Flow|Active HD-tDCS|"Participants will receive real HD-tDCS (3 milliamps for 20 minutes) for a single session.~Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes"
11300144|NCT03034954|FG001|Participant Flow|Sham HD-tDCS|"Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.~Sham HD-tDCS: Participants will receive sham HD-tDCS"
11300145|NCT03034954|OG000|Outcome|Active HD-tDCS|"Participants will receive real HD-tDCS (3 milliamps for 20 minutes) for a single session.~Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes"
11300146|NCT03034954|OG001|Outcome|Sham HD-tDCS|"Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.~Sham HD-tDCS: Participants will receive sham HD-tDCS"
11300147|NCT03034954|EG000|Reported Event|Active HD-tDCS|"Participants will receive real HD-tDCS (3 milliamps for 20 minutes) for a single session.~Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes"
10971626|NCT00916058|EG000|Reported Event|Dose Level 1|"Dose Level 1; Bendamustine 30 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 30 mg/m^2 given on day 2 of melphalan~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)"
10971627|NCT00916058|EG001|Reported Event|Dose Level 2|"Dose Level 2; Bendamustine 60 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m^2 given on the 2nd day of melphalan"
11300148|NCT03034954|EG001|Reported Event|Sham HD-tDCS|"Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.~Sham HD-tDCS: Participants will receive sham HD-tDCS"
10971628|NCT00916058|EG002|Reported Event|Dose Level 3|"Dose Level 3; Bendamustine 90 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m^2 given on the 2nd day of melphalan"
10971629|NCT00916058|EG003|Reported Event|Dose Level 4|"Dose Level 4; Bendamustine 120 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 60 mg/m^2 given on the 1st and 2nd day of melphalan"
11300149|NCT03034967|BG000|Baseline|Placebo|Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300150|NCT03034967|BG001|Baseline|Danirixin 5 mg|Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300151|NCT03034967|BG002|Baseline|Danirixin 10 mg|Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300152|NCT03034967|BG003|Baseline|Danirixin 25 mg|Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300153|NCT03034967|BG004|Baseline|Danirixin 35 mg|Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300154|NCT03034967|BG005|Baseline|Danirixin 50 mg|Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300155|NCT03034967|BG006|Baseline|Total|Total of all reporting groups
11300156|NCT03034967|FG000|Participant Flow|Placebo|Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300157|NCT03034967|FG001|Participant Flow|Danirixin 5 mg|Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300158|NCT03034967|FG002|Participant Flow|Danirixin 10 mg|Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
10971630|NCT00916058|EG004|Reported Event|Dose Level 5|"Dose Level 5; Bendamustine 150 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 90 mg/m^2 given on the 1st day of melphalan and 60 mg/m^2 given on the 2nd day of melphalan"
11300159|NCT03034967|FG003|Participant Flow|Danirixin 25 mg|Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300160|NCT03034967|FG004|Participant Flow|Danirixin 35 mg|Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300161|NCT03034967|FG005|Participant Flow|Danirixin 50 mg|Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300162|NCT03034967|OG000|Outcome|Placebo|Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300163|NCT03034967|OG001|Outcome|Danirixin 5 mg|Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300164|NCT03034967|OG002|Outcome|Danirixin 10 mg|Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300165|NCT03034967|OG003|Outcome|Danirixin 25 mg|Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300166|NCT03034967|OG004|Outcome|Danirixin 35 mg|Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300167|NCT03034967|OG005|Outcome|Danirixin 50 mg|Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300168|NCT03034967|OG000|Outcome|Danirixin 5 mg|Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300169|NCT03034967|OG001|Outcome|Danirixin 10 mg|Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300170|NCT03034967|OG002|Outcome|Danirixin 25 mg|Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300171|NCT03034967|OG003|Outcome|Danirixin 35 mg|Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300172|NCT03034967|OG004|Outcome|Danirixin 50 mg|Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300173|NCT03034967|EG000|Reported Event|Placebo|Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300174|NCT03034967|EG001|Reported Event|Danirixin 5 mg|Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300175|NCT03034967|EG002|Reported Event|Danirixin 10 mg|Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300176|NCT03034967|EG003|Reported Event|Danirixin 25 mg|Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300177|NCT03034967|EG004|Reported Event|Danirixin 35 mg|Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300178|NCT03034967|EG005|Reported Event|Danirixin 50 mg|Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
11300179|NCT03035032|BG000|Baseline|Leuprolide Acetate 22.5 Milligrams (mg)|Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
11300180|NCT03035032|FG000|Participant Flow|Leuprolide Acetate 22.5 Milligrams (mg)|Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
11300181|NCT03035032|OG000|Outcome|Leuprolide Acetate 22.5 mg|Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
11300182|NCT03035032|EG000|Reported Event|Leuprolide Acetate 22.5 mg|Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
11300183|NCT03035318|BG000|Baseline|DePuy Global® Anchor Peg Glenoid|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component.~DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation."
11300184|NCT03035318|BG001|Baseline|DePuy Instrumentation With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component.~DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™."
11300185|NCT03035318|BG002|Baseline|IRI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component.~IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™."
11300186|NCT03035318|BG003|Baseline|RTI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component.~RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™."
11300187|NCT03035318|BG004|Baseline|IRI With SmartBase|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component.~IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase."
11300188|NCT03035318|BG005|Baseline|Total|Total of all reporting groups
11300189|NCT03035318|FG000|Participant Flow|DePuy Global® Anchor Peg Glenoid|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component.~DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation."
11300190|NCT03035318|FG001|Participant Flow|DePuy Instrumentation With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component.~DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™."
11300191|NCT03035318|FG002|Participant Flow|IRI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component.~IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™."
11300192|NCT03035318|FG003|Participant Flow|RTI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component.~RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™."
11300193|NCT03035318|FG004|Participant Flow|IRI With SmartBase|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component.~IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase."
11300194|NCT03035318|OG000|Outcome|DePuy Global® Anchor Peg Glenoid|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component.~DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation."
11300195|NCT03035318|OG001|Outcome|DePuy Instrumentation With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component.~DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™."
11300196|NCT03035318|OG002|Outcome|IRI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component.~IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™."
11300197|NCT03035318|OG003|Outcome|RTI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component.~RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™."
11300198|NCT03035318|OG004|Outcome|IRI With SmartBase|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component.~IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase."
11300199|NCT03035318|EG000|Reported Event|DePuy Global® Anchor Peg Glenoid|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component.~DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation."
11300200|NCT03035318|EG001|Reported Event|DePuy Instrumentation With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component.~DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™."
11300201|NCT03035318|EG002|Reported Event|IRI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component.~IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™."
11300202|NCT03035318|EG003|Reported Event|RTI With SmartBone™|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component.~RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™."
11300203|NCT03035318|EG004|Reported Event|IRI With SmartBase|"In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component.~IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase."
11300204|NCT03035487|BG000|Baseline|Micro-ultrasound|"Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:~Low resolution transrectal ultrasound examination (LR-TRUS)~Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol~Ultrasound guided prostate exam using SOC ultrasound system~mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system~High-resolution micro-ultrasound guided prostate biopsy"
11300205|NCT03035487|FG000|Participant Flow|Micro-ultrasound|"Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:~Low resolution transrectal ultrasound examination (LR-TRUS)~Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol~Ultrasound guided prostate exam using SOC ultrasound system~mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system~High-resolution micro-ultrasound guided prostate biopsy"
11300206|NCT03035487|OG000|Outcome|Micro-ultrasound|"Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:~Low resolution transrectal ultrasound examination (LR-TRUS)~Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol~Ultrasound guided prostate exam using SOC ultrasound system~mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system~High-resolution micro-ultrasound guided prostate biopsy"
11300207|NCT03035487|EG000|Reported Event|Micro-ultrasound|"Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:~Low resolution transrectal ultrasound examination (LR-TRUS)~Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol~Ultrasound guided prostate exam using SOC ultrasound system~mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system~High-resolution micro-ultrasound guided prostate biopsy"
11300208|NCT03035708|BG000|Baseline|Varenicline|"1 mg BID (2 capsules BID)~Varenicline: 1 mg BID"
11300209|NCT03035708|BG001|Baseline|Placebo|"1 mg BID (2 capsules BID)~Placebo oral capsule: 1 mg BID"
11300210|NCT03035708|BG002|Baseline|Total|Total of all reporting groups
11300211|NCT03035708|FG000|Participant Flow|Varenicline|"1 mg BID (2 capsules BID)~Varenicline: 1 mg BID"
11300212|NCT03035708|FG001|Participant Flow|Placebo|"1 mg BID (2 capsules BID)~Placebo oral capsule: 1 mg BID"
11300213|NCT03035708|OG000|Outcome|Varenicline|"1 mg BID (2 capsules BID)~Varenicline: 1 mg BID"
11300214|NCT03035708|OG001|Outcome|Placebo|"1 mg BID (2 capsules BID)~Placebo oral capsule: 1 mg BID"
11300215|NCT03035708|OG000|Outcome|Varenicline - Smokers at Baseline|Subjects randomized to varenicline who smoked at baseline
11300216|NCT03035708|OG001|Outcome|Placebo - Smokers at Baseline|Subjects randomized to placebo who smoked at baseline
11300217|NCT03035708|EG000|Reported Event|Varenicline|"1 mg BID (2 capsules BID)~Varenicline: 1 mg BID"
11300218|NCT03035708|EG001|Reported Event|Placebo|"1 mg BID (2 capsules BID)~Placebo oral capsule: 1 mg BID"
11300219|NCT03035760|BG000|Baseline|Arm 1: 3 mg/kg Oxfendazole for 5 Days|Participants received 3 mg/kg oxfendazole orally once daily for 5 days
11300220|NCT03035760|BG001|Baseline|Arm 2: 7.5 mg/kg Oxfendazole for 5 Days|Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
11300221|NCT03035760|BG002|Baseline|Arm 3: 15 mg/kg Oxfendazole for 5 Days|Participants received 15 mg/kg oxfendazole orally once daily for 5 days
11300222|NCT03035760|BG003|Baseline|Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal|3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8
11300223|NCT03035760|BG004|Baseline|Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted|3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8
11300224|NCT03035760|BG005|Baseline|Total|Total of all reporting groups
11300225|NCT03035760|FG000|Participant Flow|Arm 1: 3 mg/kg Oxfendazole for 5 Days|Participants received 3 mg/kg oxfendazole orally once daily for 5 days
11300226|NCT03035760|FG001|Participant Flow|Arm 2: 7.5 mg/kg Oxfendazole for 5 Days|Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
11300227|NCT03035760|FG002|Participant Flow|Arm 3: 15 mg/kg Oxfendazole for 5 Days|Participants received 15 mg/kg oxfendazole orally once daily for 5 days
11300228|NCT03035760|FG003|Participant Flow|Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal|3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8
11300229|NCT03035760|FG004|Participant Flow|Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted|3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8
11300230|NCT03035760|OG000|Outcome|Arm 1: 3 mg/kg Oxfendazole for 5 Days|Participants received 3 mg/kg oxfendazole orally once daily for 5 days
11300231|NCT03035760|OG001|Outcome|Arm 2: 7.5 mg/kg Oxfendazole for 5 Days|Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
11300232|NCT03035760|OG002|Outcome|Arm 3: 15 mg/kg Oxfendazole for 5 Days|Participants received 15 mg/kg oxfendazole orally once daily for 5 days
11300233|NCT03035760|OG000|Outcome|Arm 4: 3 mg/kg Oxfendazole, Post Fast|3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8
11300234|NCT03035760|OG001|Outcome|Arm 4: 3 mg/kg Oxfendazole, Post Fed|3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8
11300235|NCT03035760|OG000|Outcome|Arm 4: 3 mg/kg Oxfendazole, Fed/Fasted|3 mg/kg oxfendazole orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8
11300236|NCT03035760|EG000|Reported Event|Arm 1: 3 mg/kg Oxfendazole for 5 Days|Participants received 3 mg/kg oxfendazole orally once daily for 5 days
11300237|NCT03035760|EG001|Reported Event|Arm 2: 7.5 mg/kg Oxfendazole for 5 Days|Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
11300238|NCT03035760|EG002|Reported Event|Arm 3: 15 mg/kg Oxfendazole for 5 Days|Participants received 15 mg/kg oxfendazole orally once daily for 5 days
11300239|NCT03035760|EG003|Reported Event|Arm 4: 3 mg/kg Oxfendazole, Post Fast|3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8
11300240|NCT03035760|EG004|Reported Event|Arm 4: 3 mg/kg Oxfendazole, Post Fed|3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8
11300241|NCT03035864|BG000|Baseline|rhNGF 20 µg/ml|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~rhNGF: Eye Drop 20 μg/mL"
11300242|NCT03035864|BG001|Baseline|Vehicle|"Vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11300243|NCT03035864|BG002|Baseline|Total|Total of all reporting groups
11300244|NCT03035864|FG000|Participant Flow|rhNGF 20 µg/ml|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~rhNGF: Eye Drop 20 μg/mL"
11300245|NCT03035864|FG001|Participant Flow|Vehicle|"Vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11300246|NCT03035864|OG000|Outcome|rhNGF 20 µg/ml|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~rhNGF: Eye Drop 20 μg/mL"
11300247|NCT03035864|OG001|Outcome|Vehicle|"Vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11300248|NCT03035864|EG000|Reported Event|rhNGF 20 µg/ml|"Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily~rhNGF: Eye Drop 20 μg/mL"
11300249|NCT03035864|EG001|Reported Event|Vehicle|"Vehicle eye drops six times daily~Vehicle: Vehicle Eye Drop"
11300250|NCT03035916|BG000|Baseline|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
11300251|NCT03035916|BG001|Baseline|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
11300252|NCT03035916|BG002|Baseline|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
11300253|NCT03035916|BG003|Baseline|Total|Total of all reporting groups
11300254|NCT03035916|FG000|Participant Flow|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
11300255|NCT03035916|FG001|Participant Flow|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
11300256|NCT03035916|FG002|Participant Flow|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
11300257|NCT03035916|OG000|Outcome|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
11300258|NCT03035916|OG001|Outcome|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
11300259|NCT03035916|OG002|Outcome|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
11300260|NCT03035916|EG000|Reported Event|Transversus Abdominis Plane Block|"The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.~Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started."
11300261|NCT03035916|EG001|Reported Event|Epidural Anesthesia|"The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.~Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery."
11300262|NCT03035916|EG002|Reported Event|Control|"The Control group receives standard IV-inhaled general anesthesia.~control: The Control group receives standard IV-inhaled general anesthesia."
11300263|NCT03035929|BG000|Baseline|Healthy|"Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.~All subjects will undergo the same procedures and interventions.~Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered."
11300264|NCT03035929|FG000|Participant Flow|Healthy|"Healthy subjects will be enrolled and each will undergo study procedures at four study visits.~All subjects will undergo the same procedures and interventions.~Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered."
11300265|NCT03035929|OG000|Outcome|Healthy|"Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.~All subjects will undergo the same procedures and interventions.~Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered."
11300266|NCT03035929|OG000|Outcome|Healthy|"10 Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.~All subjects will undergo the same procedures and interventions.~Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered."
11300267|NCT03035929|EG000|Reported Event|Healthy|"Healthy subjects will be enrolled and each will undergo study procedures at three study visits.~All subjects will undergo the same procedures and interventions.~Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered."
11300268|NCT03035942|BG000|Baseline|O Group|"Ondansetron 4 mg~Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300269|NCT03035942|BG001|Baseline|D Group|"Dexamethasone 8 mg~Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300270|NCT03035942|BG002|Baseline|S Group|"Normal saline (5 mL total volume)~Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300271|NCT03035942|BG003|Baseline|Total|Total of all reporting groups
11300272|NCT03035942|FG000|Participant Flow|O Group|"Ondansetron 4 mg~Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300273|NCT03035942|FG001|Participant Flow|D Group|"Dexamethasone 8 mg~Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300274|NCT03035942|FG002|Participant Flow|S Group|"Normal saline (5 mL total volume)~Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300275|NCT03035942|OG000|Outcome|O Group|"Ondansetron 4 mg~Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300276|NCT03035942|OG001|Outcome|D Group|"Dexamethasone 8 mg~Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300277|NCT03035942|OG002|Outcome|S Group|"Normal saline (5 mL total volume)~Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300278|NCT03035942|OG000|Outcome|D Group|"Dexamethasone 8 mg~Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300279|NCT03035942|OG001|Outcome|O Group|"Ondansetron 4 mg~Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300280|NCT03035942|EG000|Reported Event|D Group|"Dexamethasone 8 mg~Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300281|NCT03035942|EG001|Reported Event|O Group|"Ondansetron 4 mg~Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300282|NCT03035942|EG002|Reported Event|S Group|"Normal saline (5 mL total volume)~Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed."
11300283|NCT03035955|BG000|Baseline|Azelaic Acid Left/No Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
11300284|NCT03035955|BG001|Baseline|Azelaic Acid Right/No Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
11300285|NCT03035955|BG002|Baseline|Total|Total of all reporting groups
11300286|NCT03035955|FG000|Participant Flow|Azelaic Acid Left/No Treatment Right|"azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face~Azelaic acid: 15% gel twice daily for four weeks to the left side of face"
11300287|NCT03035955|FG001|Participant Flow|Azelaic Acid Right/No Treatment Left|"azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face~Azelaic acid: 15% gel twice daily for four weeks to the right side of face"
11300288|NCT03035955|OG000|Outcome|Azelaic Acid Left/no Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
11300289|NCT03035955|OG001|Outcome|Azelaic Acid Right /no Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
11300290|NCT03035955|EG000|Reported Event|Azelaic Acid|"azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face~Azelaic acid: 15% gel twice daily for four weeks to one side of face"
11300291|NCT03035955|EG001|Reported Event|no Treatment|no treatment on the other side of the face
11300292|NCT03036072|BG000|Baseline|Strict Normothermia|"Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.~Strict normothermia"
11300293|NCT03036072|BG001|Baseline|Delayed Rewarming|"Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.~Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature."
11300294|NCT03036072|BG002|Baseline|Total|Total of all reporting groups
11300295|NCT03036072|FG000|Participant Flow|Strict Normothermia|"Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.~Strict normothermia"
11300296|NCT03036072|FG001|Participant Flow|Delayed Rewarming|"Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.~Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature."
10971631|NCT00916058|EG005|Reported Event|Dose Level 6|"Dose Level 6; Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan"
11300297|NCT03036072|OG000|Outcome|Strict Normothermia|"Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.~Strict normothermia"
11300298|NCT03036072|OG001|Outcome|Delayed Rewarming|"Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.~Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature."
11300299|NCT03036072|EG000|Reported Event|Strict Normothermia|"Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.~Strict normothermia"
11300300|NCT03036072|EG001|Reported Event|Delayed Rewarming|"Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.~Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature."
11300301|NCT03036124|BG000|Baseline|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11300302|NCT03036124|BG001|Baseline|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11300303|NCT03036124|BG002|Baseline|Total|Total of all reporting groups
11300304|NCT03036124|FG000|Participant Flow|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11300305|NCT03036124|FG001|Participant Flow|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11300306|NCT03036124|OG000|Outcome|Dapa 10 mg|Dapagliflozin 10 mg tablets administered orally once daily
11300307|NCT03036124|OG001|Outcome|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11300308|NCT03036124|EG000|Reported Event|Dapa 10mg|Dapagliflozin 10 mg, given once daily per oral use.
11300309|NCT03036124|EG001|Reported Event|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
11300310|NCT03036150|BG000|Baseline|Dapagliflozin|Dapagliflozin 10 mg, given once daily per oral use
11300311|NCT03036150|BG001|Baseline|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
11300312|NCT03036150|BG002|Baseline|Total|Total of all reporting groups
10971632|NCT00916058|EG006|Reported Event|Phase 2|"Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min)~Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)~Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan"
10971633|NCT00916136|BG000|Baseline|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
11300313|NCT03036150|FG000|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg, given once daily per oral use
11300314|NCT03036150|FG001|Participant Flow|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
11300315|NCT03036150|OG000|Outcome|Dapagliflozin|Dapagliflozin 10 mg, given once daily per oral use
11300316|NCT03036150|OG001|Outcome|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
11300317|NCT03036150|EG000|Reported Event|Dapa 10 mg|Dapagliflozin 10 mg, given once daily per oral use
11300318|NCT03036150|EG001|Reported Event|Placebo|Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
11300319|NCT03036163|BG000|Baseline|Cohort 1|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)~PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state"
11300320|NCT03036163|BG001|Baseline|Cohort 2|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)~PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state"
11300321|NCT03036163|BG002|Baseline|Cohort 3|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)~PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state"
11300322|NCT03036163|BG003|Baseline|Cohort 4|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)~PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state"
11300323|NCT03036163|BG004|Baseline|Cohort 5|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)~PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state"
11300324|NCT03036163|BG005|Baseline|Cohort 6|"5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days~PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days"
11300325|NCT03036163|BG006|Baseline|Cohort 7|"5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days~PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days"
11300326|NCT03036163|BG007|Baseline|Total|Total of all reporting groups
11300327|NCT03036163|FG000|Participant Flow|Cohort 1|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)~PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state"
11300328|NCT03036163|FG001|Participant Flow|Cohort 2|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)~PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state"
11300329|NCT03036163|FG002|Participant Flow|Cohort 3|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)~PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state"
11300330|NCT03036163|FG003|Participant Flow|Cohort 4|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)~PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state"
11300331|NCT03036163|FG004|Participant Flow|Cohort 5|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)~PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state"
11300332|NCT03036163|FG005|Participant Flow|Cohort 6|"5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days~PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days"
11300333|NCT03036163|FG006|Participant Flow|Cohort 7|"5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days~PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days"
11300334|NCT03036163|OG000|Outcome|Cohort 1|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)~PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state"
11300335|NCT03036163|OG001|Outcome|Cohort 2|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)~PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state"
11300336|NCT03036163|OG002|Outcome|Cohort 3|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)~PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state"
11300337|NCT03036163|OG003|Outcome|Cohort 4|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)~PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state"
11300338|NCT03036163|OG004|Outcome|Cohort 5|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)~PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state"
11300339|NCT03036163|OG005|Outcome|Cohort 6|"5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days~PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days"
11300340|NCT03036163|OG006|Outcome|Cohort 7|"5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days~PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days"
11300341|NCT03036163|EG000|Reported Event|Cohort 1|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)~PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state"
11300342|NCT03036163|EG001|Reported Event|Cohort 2|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)~PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state"
11300343|NCT03036163|EG002|Reported Event|Cohort 3|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)~PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state"
11300344|NCT03036163|EG003|Reported Event|Cohort 4|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)~PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state"
11300345|NCT03036163|EG004|Reported Event|Cohort 5|"6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)~PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state"
11300346|NCT03036163|EG005|Reported Event|Cohort 6|"5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days~PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days"
11300347|NCT03036163|EG006|Reported Event|Cohort 7|"5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days~PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days"
11300348|NCT03036215|BG000|Baseline|Traditional Self-Care Control Arm|Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
11300349|NCT03036215|BG001|Baseline|PACT Experimental Arm|PACT Experimental Arm: The study employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
11300350|NCT03036215|BG002|Baseline|Total|Total of all reporting groups
11300351|NCT03036215|FG000|Participant Flow|Traditional Self-Care Control Arm|Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
11300352|NCT03036215|FG001|Participant Flow|PACT Experimental Arm|Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
11300353|NCT03036215|OG000|Outcome|Traditional Self-Care Control Arm|Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
11300354|NCT03036215|OG001|Outcome|PACT Experimental Arm|Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
11300355|NCT03036215|OG000|Outcome|Traditional Self-Care Control Arm|Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
11300356|NCT03036215|OG001|Outcome|PACT Experimental Arm|The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
11300357|NCT03036215|OG001|Outcome|PACT Experimental Arm|PACT Experimental Arm: The study employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
11300358|NCT03036215|EG000|Reported Event|Traditional Self-Care Control Arm|Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
11300359|NCT03036215|EG001|Reported Event|PACT Experimental Arm|PACT intervention employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
11300360|NCT03036293|BG000|Baseline|Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300361|NCT03036293|BG001|Baseline|Placebo, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Placebo: Tablet for oral use."
11300362|NCT03036293|BG002|Baseline|Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300363|NCT03036293|BG003|Baseline|Placebo, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Placebo: Tablet for oral use."
11300364|NCT03036293|BG004|Baseline|Total|Total of all reporting groups
11300365|NCT03036293|FG000|Participant Flow|Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300366|NCT03036293|FG001|Participant Flow|Placebo, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Placebo: Tablet for oral use."
11300367|NCT03036293|FG002|Participant Flow|Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300368|NCT03036293|FG003|Participant Flow|Placebo, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Placebo: Tablet for oral use."
11300369|NCT03036293|OG000|Outcome|Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300370|NCT03036293|OG001|Outcome|Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300371|NCT03036293|OG002|Outcome|Placebo-2 + Placebo-4|Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)
11300372|NCT03036293|EG000|Reported Event|Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300373|NCT03036293|EG001|Reported Event|Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)|"Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.~Tenoten: Tablet for oral use."
11300374|NCT03036293|EG002|Reported Event|Placebo-2 + Placebo-4|"Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)~Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed."
11300375|NCT03036384|BG000|Baseline|35mg HB Prilocaine|
11300376|NCT03036384|BG001|Baseline|40mg HB Prilocaine|
11300377|NCT03036384|BG002|Baseline|45mg HB Prilocaine|
11300378|NCT03036384|BG003|Baseline|50mg HB Prilocaine|
11300379|NCT03036384|BG004|Baseline|Total|Total of all reporting groups
11300380|NCT03036384|FG000|Participant Flow|Cohort 1|45mg HB prilocaine initial dose; 4 patients
11300381|NCT03036384|FG001|Participant Flow|Cohort 2|40mg HB prilocaine following CRM results; 4 patients
11300382|NCT03036384|FG002|Participant Flow|Cohort 3|40mg HB prilocaine following CRM results; 4 patients
11300383|NCT03036384|FG003|Participant Flow|Cohort 4|35mg HB prilocaine following CRM results; 4 patients
11300384|NCT03036384|FG004|Participant Flow|Cohort 5|50mg HB prilocaine following CRM results, 4 patients
11300385|NCT03036384|FG005|Participant Flow|Cohort 6|45mg HB prilocaine following CRM results, 4 patients
11300386|NCT03036384|FG006|Participant Flow|Cohort 7|45mg HB prilocaine following CRM results, 4 patients
11300387|NCT03036384|FG007|Participant Flow|Cohort 8|45mg HB prilocaine following CRM results, 4 patients
11300388|NCT03036384|FG008|Participant Flow|Cohort 9|40mg HB prilocaine following CRM results, 4 patients
11300389|NCT03036384|FG009|Participant Flow|Cohort 10|45mg HB prilocaine following CRM results, 4 patients
11300390|NCT03036384|OG000|Outcome|Cohort 1|45mg
11300391|NCT03036384|OG001|Outcome|Cohort 2|40mg
11300392|NCT03036384|OG002|Outcome|Cohort 3|40mg
10971634|NCT00916136|BG001|Baseline|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
11300393|NCT03036384|OG003|Outcome|Cohort 4|35mg
11300394|NCT03036384|OG004|Outcome|Cohort 5|50mg
11300395|NCT03036384|OG005|Outcome|Cohort 6|45mg
11300396|NCT03036384|OG006|Outcome|Cohort 7|45mg
11300397|NCT03036384|OG007|Outcome|Cohort 8|45mg
11300398|NCT03036384|OG008|Outcome|Cohort 9|40mg
11300399|NCT03036384|OG009|Outcome|Cohort 10|45mg
11300400|NCT03036384|OG000|Outcome|45mg HB Prilocaine|
11300401|NCT03036384|OG001|Outcome|50mg HB Prilocaine|
11300402|NCT03036384|EG000|Reported Event|35mg HB Prilocaine|
11300403|NCT03036384|EG001|Reported Event|40mg HB Prilocaine|
11300404|NCT03036384|EG002|Reported Event|45mg HB Prilocaine|
11300405|NCT03036384|EG003|Reported Event|50mg HB Prilocaine|
11300406|NCT03036813|BG000|Baseline|Voxelotor 900mg|Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks.
11300407|NCT03036813|BG001|Baseline|Voxelotor 1500mg|Participants received voxelotor 1500 mg; administered orally, once daily for 72 weeks
11300408|NCT03036813|BG002|Baseline|Placebo|Matching Placebo; administered orally, once daily for 72 weeks
11300409|NCT03036813|BG003|Baseline|Total|Total of all reporting groups
11300410|NCT03036813|FG000|Participant Flow|Voxelotor 900mg|Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks.
11300411|NCT03036813|FG001|Participant Flow|Voxelotor 1500mg|Participants received voxelotor 1500 mg administered orally, once daily for 72 weeks.
11300412|NCT03036813|FG002|Participant Flow|Placebo|Matching placebo; administered orally, once daily for 72 weeks.
11300413|NCT03036813|OG000|Outcome|Voxelotor 900 mg|Participants received voxelotor 900 mg administered orally, once daily
11300414|NCT03036813|OG001|Outcome|Voxelotor 1500 mg|Participants received voxelotor 1500mg; administered orally, once daily
10971635|NCT00916136|BG002|Baseline|Total|Total of all reporting groups
11300415|NCT03036813|OG002|Outcome|Placebo|Participants received matching placebo; administered orally, once daily
11300416|NCT03036813|OG000|Outcome|Voxelotor 900 mg|Participants received voxelotor 900 mg; administered orally, once daily
11300417|NCT03036813|OG001|Outcome|Voxelotor 1500 mg|Participants received voxelotor 1500 mg; administered orally, once daily
11300418|NCT03036813|OG002|Outcome|Placebo|Participants will receive matching placebo; administered orally, once daily
11300419|NCT03036813|EG000|Reported Event|Voxelotor 900 mg|Participants received voxelotor 900 mg, administered orally, once daily
11300420|NCT03036813|EG001|Reported Event|Voxelotor 1500 mg|Participants received voxelotor 1500 mg administered orally, once daily
11300421|NCT03036813|EG002|Reported Event|Placebo|Participants received matching placebo; administered orally, once daily
11300422|NCT03036839|BG000|Baseline|LDV/SOF for 8 Weeks|Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
11300423|NCT03036839|BG001|Baseline|LDV/SOF for 12 Weeks|Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
11300424|NCT03036839|BG002|Baseline|LDV/SOF for 24 Weeks|Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
11300425|NCT03036839|BG003|Baseline|Total|Total of all reporting groups
11300426|NCT03036839|FG000|Participant Flow|LDV/SOF for 8 Weeks|Treatment-naive genotype 1 participants without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.
11300427|NCT03036839|FG001|Participant Flow|LDV/SOF for 12 Weeks|Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
11300428|NCT03036839|FG002|Participant Flow|LDV/SOF for 24 Weeks|Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
11300429|NCT03036839|OG000|Outcome|LDV/SOF for 8 Weeks|Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
11300430|NCT03036839|OG001|Outcome|LDV/SOF for 12 Weeks|Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
11300431|NCT03036839|OG002|Outcome|LDV/SOF for 24 Weeks|Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
11300432|NCT03036839|EG000|Reported Event|LDV/SOF for 8 Weeks|Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
11300433|NCT03036839|EG001|Reported Event|LDV/SOF for 12 Weeks|Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
11300434|NCT03036839|EG002|Reported Event|LDV/SOF for 24 Weeks|Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
11300435|NCT03036852|BG000|Baseline|SOF/VEL (GT-1)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
11300436|NCT03036852|BG001|Baseline|SOF/VEL (GT-2)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
11300437|NCT03036852|BG002|Baseline|SOF/VEL (GT-3)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
11300438|NCT03036852|BG003|Baseline|SOF/VEL (GT-4)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
11300439|NCT03036852|BG004|Baseline|SOF/VEL (GT-6)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
11300440|NCT03036852|BG005|Baseline|SOF/VEL (Indeterminate)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
11300441|NCT03036852|BG006|Baseline|Total|Total of all reporting groups
11300442|NCT03036852|FG000|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
11300443|NCT03036852|OG000|Outcome|SOF/VEL (Total)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11300444|NCT03036852|OG001|Outcome|SOF/VEL (GT-1)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
11300445|NCT03036852|OG002|Outcome|SOF/VEL (GT-2)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
11300446|NCT03036852|OG003|Outcome|SOF/VEL (GT-3)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
11300447|NCT03036852|OG004|Outcome|SOF/VEL (GT-4)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
11300448|NCT03036852|OG005|Outcome|SOF/VEL (GT-6)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
11300449|NCT03036852|OG006|Outcome|SOF/VEL (Indeterminate)|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
11300450|NCT03036852|OG000|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11300451|NCT03036852|EG000|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11300452|NCT03037203|BG000|Baseline|Treatment Sequence A|Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.
11300453|NCT03037203|BG001|Baseline|Treatment Sequence B|Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.
11300454|NCT03037203|BG002|Baseline|Treatment Sequence C|Subjects in Treatment Sequence C were assigned Placebo for each Period.
11300455|NCT03037203|BG003|Baseline|Total|Total of all reporting groups
11300456|NCT03037203|FG000|Participant Flow|Treatment Sequence A|Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.
11300457|NCT03037203|FG001|Participant Flow|Treatment Sequence B|Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.
11300458|NCT03037203|FG002|Participant Flow|Treatment Sequence C|Subjects in Treatment Sequence C were assigned Placebo for each Period.
11300459|NCT03037203|OG000|Outcome|JZP-110 75mg|The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
11300460|NCT03037203|OG001|Outcome|JZP-110 150mg|The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
11300461|NCT03037203|OG002|Outcome|JZP-110 300mg|The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
11300462|NCT03037203|OG003|Outcome|Placebo|The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
11300463|NCT03037203|OG000|Outcome|JZP-110 75mg|The JZP-110 75 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
11300464|NCT03037203|OG001|Outcome|JZP-110 150mg|The JZP-110 150 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
11300465|NCT03037203|OG002|Outcome|JZP-110 300mg|The JZP-110 300 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
11300466|NCT03037203|OG003|Outcome|Placebo|The Placebo group includes all subjects in the mITT population from Sequences A, B, and C - 64 subjects in total.
11300467|NCT03037203|OG000|Outcome|JZP-110 75mg|The JZP-110 75 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
11300468|NCT03037203|OG001|Outcome|JZP-110 150mg|The JZP-110 150 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
11300469|NCT03037203|OG002|Outcome|JZP-110 300mg|The JZP-110 300 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
11300470|NCT03037203|OG003|Outcome|Placebo|The Placebo group includes all subjects in the mITT population in Group 1 from Sequences A, B, and C - 53 subjects in total.
11300471|NCT03037203|EG000|Reported Event|JZP-110 75 mg|The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
11300472|NCT03037203|EG001|Reported Event|JZP-110 150 mg|The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
11300473|NCT03037203|EG002|Reported Event|JZP-110 300 mg|The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
11300474|NCT03037203|EG003|Reported Event|Placebo|The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
11300475|NCT03037281|BG000|Baseline|Septic|"Patients admitted to the intensive care unit with a diagnosis of sepsis. For the purposes of this study, patients must have a diagnosis of sepsis; SIRS (2 of pulse >90, WCC, BP, Oxygen(Dellinger et al., 2013)) with microbiological evidence of infection (positive blood culture, urine dipstick, compatible history or examination, radiographic evidence)~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300476|NCT03037281|BG001|Baseline|Healthy Volunteers|"Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300477|NCT03037281|BG002|Baseline|Total|Total of all reporting groups
11300478|NCT03037281|FG000|Participant Flow|Septic|"Patients admitted to the intensive care unit with a diagnosis of sepsis. For the purposes of this study, patients must have a diagnosis of sepsis; SIRS (2 of pulse >90, WCC, BP, Oxygen(Dellinger et al., 2013)) with microbiological evidence of infection (positive blood culture, urine dipstick, compatible history or examination, radiographic evidence)~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300479|NCT03037281|FG001|Participant Flow|Healthy Volunteers|"Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300480|NCT03037281|OG000|Outcome|Septic|"Patients admitted to the intensive care unit with a diagnosis of sepsis. For the purposes of this study, patients must have a diagnosis of sepsis; SIRS (2 of pulse >90, WCC, BP, Oxygen(Dellinger et al., 2013)) with microbiological evidence of infection (positive blood culture, urine dipstick, compatible history or examination, radiographic evidence)~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300481|NCT03037281|OG001|Outcome|Septic (+NOP Antagonist SB612111)|Cells harvested from patients with sepsis, treated in an environment containing the NOP antagonist SB612111
11300482|NCT03037281|OG002|Outcome|Septic (N/OFQ Control)|Control treatment of biosensor cells with N/OFQ as a control
11300483|NCT03037281|OG003|Outcome|Healthy Volunteers|"Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300484|NCT03037281|OG004|Outcome|Healthy Volunteers (+NOP Antagonist SB612111)|Cells harvested from healthy volunteers in an environment containing the NOP antagonist SB612111
11300485|NCT03037281|OG005|Outcome|Healthy Volunteers (N/OFQ Control)|Cells taken from healthy volunteers treated with N/OFQ as a control
11300486|NCT03037281|OG001|Outcome|Healthy Volunteers|"Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300487|NCT03037281|EG000|Reported Event|Septic|"Patients admitted to the intensive care unit with a diagnosis of sepsis. For the purposes of this study, patients must have a diagnosis of sepsis; SIRS (2 of pulse >90, WCC, BP, Oxygen(Dellinger et al., 2013)) with microbiological evidence of infection (positive blood culture, urine dipstick, compatible history or examination, radiographic evidence)~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300488|NCT03037281|EG001|Reported Event|Healthy Volunteers|"Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.~Septic: 30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately."
11300489|NCT03037307|BG000|Baseline|Overall Study Participants|All randomized participants who received test adhesive, positive control adhesive and did not receive any treatment were included in the baseline assessment.
11300490|NCT03037307|FG000|Participant Flow|Test Adhesive/No Treatment/Positive Control Adhesive|Participants in this arm received topical application of test adhesive, followed by no treatment, positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products were applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300491|NCT03037307|FG001|Participant Flow|Test Adhesive/Positive Control Adhesive/No Treatment|Participants in this arm received topical application of test adhesive, followed by positive control adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300492|NCT03037307|FG002|Participant Flow|No Treatment/Test Adhesive/Positive Control Adhesive|Participants in this arm received no treatment, followed by topical application of test adhesive and positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300493|NCT03037307|FG003|Participant Flow|No Treatment/Positive Control Adhesive/Test Adhesive|Participants in this arm received no treatment, followed by topical application of positive control adhesive and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300494|NCT03037307|FG004|Participant Flow|Positive Control Adhesive/Test Adhesive/No Treatment|Participants in this arm received topical application of positive control adhesive, followed by test adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300495|NCT03037307|FG005|Participant Flow|Positive Control Adhesive/No Treatment/Test Adhesive|Participants in this arm received topical application of positive control adhesive, followed by no treatment and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300496|NCT03037307|OG000|Outcome|Positive Control Adhesive|Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300497|NCT03037307|OG001|Outcome|Negative Control|Participants of this arm did not receive any adhesive to apply on upper denture.
11300498|NCT03037307|OG000|Outcome|Test Adhesive|Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300499|NCT03037307|EG000|Reported Event|Test Adhesive|Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300500|NCT03037307|EG001|Reported Event|Positive Control Adhesive|Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
11300501|NCT03037307|EG002|Reported Event|Negative Control|Participants of this arm did not receive any adhesive to apply on upper denture.
11300502|NCT03037307|EG003|Reported Event|Overall Participants|This arm included all the participants randomized to receive test adhesive, positive control adhesive and no treatment.
11300503|NCT03037489|BG000|Baseline|Group A|Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks.
11300504|NCT03037489|BG001|Baseline|Group B|Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
11300505|NCT03037489|BG002|Baseline|Total|Total of all reporting groups
11300506|NCT03037489|FG000|Participant Flow|Group A|Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 (NCT02705625) and whose symptoms did not clinically significantly deteriorate as defined by an increase in the Numeric Rating Scale (NRS) of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks.
11300507|NCT03037489|FG001|Participant Flow|Group B|Study Group B was recruited from patients receiving placebo in Study MIV-711-201 (NCT02705625) having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
11300508|NCT03037489|OG000|Outcome|Group A|Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks.
11300509|NCT03037489|OG001|Outcome|Group B|Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
11300510|NCT03037489|EG000|Reported Event|Group A|Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks.
11300511|NCT03037489|EG001|Reported Event|Group B|Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
11300512|NCT03037541|BG000|Baseline|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
11300513|NCT03037541|BG001|Baseline|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
11300514|NCT03037541|BG002|Baseline|Total|Total of all reporting groups
11300515|NCT03037541|FG000|Participant Flow|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
11300516|NCT03037541|FG001|Participant Flow|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
11300517|NCT03037541|OG000|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
11300518|NCT03037541|OG001|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
11300519|NCT03037541|EG000|Reported Event|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
11300520|NCT03037541|EG001|Reported Event|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
11300521|NCT03037580|BG000|Baseline|Oral Treprostinil|"Sustained-release oral tablets for TID administration~Oral treprostinil: Sustained-release oral tablets for TID administration"
11300522|NCT03037580|BG001|Baseline|Placebo|"Placebo (sugar pill) for TID oral administration~Placebo: Placebo (sugar pill) for TID oral administration"
11300523|NCT03037580|BG002|Baseline|Total|Total of all reporting groups
11300524|NCT03037580|FG000|Participant Flow|Oral Treprostinil|"Sustained-release oral tablets for TID administration~Oral treprostinil: Sustained-release oral tablets for TID administration"
11300525|NCT03037580|FG001|Participant Flow|Placebo|"Placebo (sugar pill) for TID oral administration~Placebo: Placebo (sugar pill) for TID oral administration"
11300526|NCT03037580|OG000|Outcome|Oral Treprostinil|"Sustained-release oral tablets for TID administration~Oral treprostinil: Sustained-release oral tablets for TID administration"
11300527|NCT03037580|OG001|Outcome|Placebo|"Placebo (sugar pill) for TID oral administration~Placebo: Placebo (sugar pill) for TID oral administration"
11300528|NCT03037580|EG000|Reported Event|Oral Treprostinil|"Sustained-release oral tablets for TID administration~Oral treprostinil: Sustained-release oral tablets for TID administration"
11300529|NCT03037580|EG001|Reported Event|Placebo|"Placebo (sugar pill) for TID oral administration~Placebo: Placebo (sugar pill) for TID oral administration"
11300530|NCT03037619|BG000|Baseline|Fitbit|"Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.~Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months"
11300531|NCT03037619|BG001|Baseline|Fitbit&Support|"Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months.~Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months."
11300532|NCT03037619|BG002|Baseline|Total|Total of all reporting groups
11300533|NCT03037619|FG000|Participant Flow|Fitbit|"Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.~Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months"
11300534|NCT03037619|FG001|Participant Flow|Fitbit+Support|"Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months.~Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months."
11300535|NCT03037619|OG000|Outcome|Fitbit|"Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.~Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months"
11300536|NCT03037619|OG001|Outcome|Fitbit+Support|"Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months.~Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months."
11300537|NCT03037619|EG000|Reported Event|Fitbit|"Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.~Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months"
11300538|NCT03037619|EG001|Reported Event|Fitbit+Support|"Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months.~Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months."
10848377|NCT00289783|FG000|Participant Flow|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11300539|NCT03037905|BG000|Baseline|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
11300540|NCT03037905|BG001|Baseline|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
11300541|NCT03037905|BG002|Baseline|Total|Total of all reporting groups
11300542|NCT03037905|FG000|Participant Flow|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
11300543|NCT03037905|FG001|Participant Flow|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
11300544|NCT03037905|OG000|Outcome|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
11300545|NCT03037905|OG001|Outcome|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
11300546|NCT03037905|OG000|Outcome|SignatureSuite OR|"The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.~SignatureSuite OR Integration System by STERIS Corporation: SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery."
11300547|NCT03037905|OG001|Outcome|Standard OR|Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.
11300548|NCT03037905|EG000|Reported Event|SignatureSuite OR|"Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.~SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR."
11300549|NCT03037905|EG001|Reported Event|Standard OR|Patients who's surgeon has been randomized into the standard operating room.
11300550|NCT03037983|BG000|Baseline|Active|"Subjects will receive actual rTMS treatment.~Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between."
11300551|NCT03037983|BG001|Baseline|Sham|"Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.~Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject."
11300552|NCT03037983|BG002|Baseline|Total|Total of all reporting groups
11300553|NCT03037983|FG000|Participant Flow|Active|"Subjects will receive actual rTMS treatment.~Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between."
11300554|NCT03037983|FG001|Participant Flow|Sham|"Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.~Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject."
11300555|NCT03037983|OG000|Outcome|Active|"Subjects will receive actual rTMS treatment.~Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between."
11300556|NCT03037983|OG001|Outcome|Sham|"Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.~Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject."
11300557|NCT03037983|EG000|Reported Event|Active|"Subjects will receive actual rTMS treatment.~Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between."
11300558|NCT03037983|EG001|Reported Event|Sham|"Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.~Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject."
11300559|NCT03038113|BG000|Baseline|Part 1 - RO7062931 0.1 mg/kg|Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
11300560|NCT03038113|BG001|Baseline|Part 1 - RO7062931 0.3 mg/kg|Participants received a single SC injection of 0.3 mg/kg RO7062931.
11300561|NCT03038113|BG002|Baseline|Part 1 - RO7062931 1.0 mg/kg|Participants received a single SC injection of 1.0 mg/kg RO7062931.
11300562|NCT03038113|BG003|Baseline|Part 1 - RO7062931 2.0 mg/kg|Participants received a single SC injection of 2.0 mg/kg RO7062931.
11300563|NCT03038113|BG004|Baseline|Part 1 - RO7062931 3.0 mg/kg|Participants received a single SC injection of 3.0 mg/kg RO7062931.
11300564|NCT03038113|BG005|Baseline|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300565|NCT03038113|BG006|Baseline|Part 1 - Placebo|Participants received a single SC injection of placebo matched to RO7062931.
11300566|NCT03038113|BG007|Baseline|Part 2a - RO7062931 0.5 mg/kg Q1M|Participants received two QM SC injections of 0.5 mg/kg RO7062931.
11300567|NCT03038113|BG008|Baseline|Part 2a - RO7062931 1.5 mg/kg Q1M|Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
11300568|NCT03038113|BG009|Baseline|Part 2a - RO7062931 3.0 mg/kg Q1M|Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
11300569|NCT03038113|BG010|Baseline|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300570|NCT03038113|BG011|Baseline|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300571|NCT03038113|BG012|Baseline|Part 2b - RO7062931 4.0 mg/kg QW|Participants received four QW SC injections of 4.0 mg/kg RO7062931.
11300572|NCT03038113|BG013|Baseline|Part 2 - Placebo|Participants received SC placebo matched to RO7062931 over a 4-week period.
11300573|NCT03038113|BG014|Baseline|Total|Total of all reporting groups
11300574|NCT03038113|FG000|Participant Flow|Part 1 - RO7062931 0.1 mg/kg|Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
11300575|NCT03038113|FG001|Participant Flow|Part 1 - RO7062931 0.3 mg/kg|Participants received a single SC injection of 0.3 mg/kg RO7062931.
11300576|NCT03038113|FG002|Participant Flow|Part 1 - RO7062931 1.0 mg/kg|Participants received a single SC injection of 1.0 mg/kg RO7062931.
11300577|NCT03038113|FG003|Participant Flow|Part 1 - RO7062931 2.0 mg/kg|Participants received a single SC injection of 2.0 mg/kg RO7062931.
11300578|NCT03038113|FG004|Participant Flow|Part 1 - RO7062931 3.0 mg/kg|Participants received a single SC injection of 3.0 mg/kg RO7062931.
11300579|NCT03038113|FG005|Participant Flow|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300580|NCT03038113|FG006|Participant Flow|Part 1 - Placebo|Participants received a single SC injection of placebo matched to RO7062931.
11300581|NCT03038113|FG007|Participant Flow|Part 2a - RO7062931 0.5 mg/kg Q1M|Participants received two QM SC injections of 0.5 mg/kg RO7062931.
11300582|NCT03038113|FG008|Participant Flow|Part 2a - RO7062931 1.5 mg/kg Q1M|Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
11300583|NCT03038113|FG009|Participant Flow|Part 2a - RO7062931 3.0 mg/kg Q1M|Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
11300584|NCT03038113|FG010|Participant Flow|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300585|NCT03038113|FG011|Participant Flow|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300586|NCT03038113|FG012|Participant Flow|Part 2b - RO7062931 4.0 mg/kg QW|Participants received four QW SC injections of 4.0 mg/kg RO7062931.
11300587|NCT03038113|FG013|Participant Flow|Part 2 - Placebo|Participants received SC placebo matched to RO7062931 over a 4-week period.
11300588|NCT03038113|OG000|Outcome|Part 1 - RO7062931 0.1 mg/kg|Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
11300589|NCT03038113|OG001|Outcome|Part 1 - RO7062931 0.3 mg/kg|Participants received a single SC injection of 0.3 mg/kg RO7062931.
11300590|NCT03038113|OG002|Outcome|Part 1 - RO7062931 1.0 mg/kg|Participants received a single SC injection of 1.0 mg/kg RO7062931.
11300591|NCT03038113|OG003|Outcome|Part 1 - RO7062931 2.0 mg/kg|Participants received a single SC injection of 2.0 mg/kg RO7062931.
11300592|NCT03038113|OG004|Outcome|Part 1 - RO7062931 3.0 mg/kg|Participants received a single SC injection of 3.0 mg/kg RO7062931.
11300593|NCT03038113|OG005|Outcome|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300594|NCT03038113|OG006|Outcome|Part 1 - Placebo|Participants received a single SC injection of placebo matched to RO7062931.
11300595|NCT03038113|OG007|Outcome|Part 2a - RO7062931 0.5 mg/kg Q1M|Participants received two QM SC injections of 0.5 mg/kg RO7062931.
11300596|NCT03038113|OG008|Outcome|Part 2a - RO7062931 1.5 mg/kg Q1M|Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
11300597|NCT03038113|OG009|Outcome|Part 2a - RO7062931 3.0 mg/kg Q1M|Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
11300598|NCT03038113|OG010|Outcome|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300599|NCT03038113|OG011|Outcome|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300600|NCT03038113|OG012|Outcome|Part 2b - RO7062931 4.0 mg/kg QW|Participants received four QW SC injections of 4.0 mg/kg RO7062931.
11300601|NCT03038113|OG013|Outcome|Part 2 - Placebo|Participants received SC placebo matched to RO7062931 over a 4-week period.
11300602|NCT03038113|OG000|Outcome|Part 2a - RO7062931 0.5 mg/kg Q1M|Participants received two QM SC injections of 0.5 mg/kg RO7062931.
11300603|NCT03038113|OG001|Outcome|Part 2a - RO7062931 1.5 mg/kg Q1M|Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
11300604|NCT03038113|OG002|Outcome|Part 2a - RO7062931 3.0 mg/kg Q1M|Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
11300605|NCT03038113|OG003|Outcome|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300606|NCT03038113|OG004|Outcome|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300607|NCT03038113|OG005|Outcome|Part 2b - RO7062931 4.0 mg/kg QW|Participants received four QW SC injections of 4.0 mg/kg RO7062931.
11300608|NCT03038113|OG006|Outcome|Part 2 - Placebo|Participants received SC placebo matched to RO7062931 over a 4-week period.
11300609|NCT03038113|OG000|Outcome|Part 1 - RO7062931 0.1 mg/kg|Participants received a single SC injection of 0.1 mg/kg RO7062931.
11300610|NCT03038113|OG004|Outcome|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300611|NCT03038113|OG005|Outcome|Part 1 - RO7062931 3.0 mg/kg|Participants received a single subcutaneous (SC) injection of 3.0 mg/kg RO7062931.
11300612|NCT03038113|OG005|Outcome|Part 1 - RO7062931 3.0 mg/kg|Participants received a single SC injection of 3.0 mg/kg RO7062931.
11300613|NCT03038113|OG005|Outcome|Part 1 - RO7062931 3.0 mg/kg|Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
11300614|NCT03038113|OG003|Outcome|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300615|NCT03038113|OG004|Outcome|Part 1 - RO7062931 2.0 mg/kg|Participants received a single SC injection of 2.0 mg/kg RO7062931.
11300616|NCT03038113|OG000|Outcome|Part 1 - RO7062931 0.1 mg/kg|Participants received a single subcutaneous (SC) injection of 2.0 mg/kg RO7062931.
11300617|NCT03038113|OG003|Outcome|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300618|NCT03038113|OG004|Outcome|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300619|NCT03038113|EG000|Reported Event|Part 1 - RO7062931 0.1 mg/kg|Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
11300620|NCT03038113|EG001|Reported Event|Part 1 - RO7062931 0.3 mg/kg|Participants received a single SC injection of 0.3 mg/kg RO7062931.
11300621|NCT03038113|EG002|Reported Event|Part 1 - RO7062931 1.0 mg/kg|Participants received a single SC injection of 1.0 mg/kg RO7062931.
11300622|NCT03038113|EG003|Reported Event|Part 1 - RO7062931 2.0 mg/kg|Participants received a single SC injection of 2.0 mg/kg RO7062931.
11300623|NCT03038113|EG004|Reported Event|Part 1 - RO7062931 3.0 mg/kg|Participants received a single SC injection of 3.0 mg/kg RO7062931.
11300624|NCT03038113|EG005|Reported Event|Part 1 - RO7062931 4.0 mg/kg|Participants received a single SC injection of 4.0 mg/kg RO7062931.
11300625|NCT03038113|EG006|Reported Event|Part 1 - Placebo|Participants received a single SC injection of placebo matched to RO7062931.
11300626|NCT03038113|EG007|Reported Event|Part 2a - RO7062931 0.5 mg/kg Q1M|Participants received two QM SC injections of 0.5 mg/kg RO7062931.
11300627|NCT03038113|EG008|Reported Event|Part 2a - RO7062931 1.5 mg/kg Q1M|Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
11300628|NCT03038113|EG009|Reported Event|Part 2a - RO7062931 3.0 mg/kg Q1M|Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
11300629|NCT03038113|EG010|Reported Event|Part 2b - RO7062931 3.0 mg/kg QW|Participants received five QW SC injections of 3.0 mg/kg RO7062931.
11300630|NCT03038113|EG011|Reported Event|Part 2b - RO7062931 3.0 mg/kg Q2W|Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
11300631|NCT03038113|EG012|Reported Event|Part 2b - RO7062931 4.0 mg/kg QW|Participants received four QW SC injections of 4.0 mg/kg RO7062931.
11300632|NCT03038113|EG013|Reported Event|Part 2 - Placebo|Participants received SC placebo matched to RO7062931 over a 4-week period.
11300633|NCT03038126|BG000|Baseline|CCHT|"Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).~CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)."
11300634|NCT03038126|BG001|Baseline|Usual Care|Usual care: Standard clinical care
11300635|NCT03038126|BG002|Baseline|Total|Total of all reporting groups
11300636|NCT03038126|FG000|Participant Flow|CCHT|"Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).~CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)."
11300637|NCT03038126|FG001|Participant Flow|Usual Care|Usual care: Standard clinical care
11300638|NCT03038126|OG000|Outcome|CCHT|"Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).~CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)."
11300639|NCT03038126|OG001|Outcome|Usual Care|Usual care: Standard clinical care
11300640|NCT03038126|EG000|Reported Event|CCHT|"Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).~CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)."
11300641|NCT03038126|EG001|Reported Event|Usual Care|Usual care: Standard clinical care
10971636|NCT00916136|FG000|Participant Flow|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
11300642|NCT03038308|BG000|Baseline|ROP Intervention|"Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study~Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole"
11300643|NCT03038308|FG000|Participant Flow|ROP Intervention|"Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study~Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole"
11300644|NCT03038308|OG000|Outcome|ROP Intervention|"Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study~Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole"
11300645|NCT03038308|EG000|Reported Event|ROP Intervention|"Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study~Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole"
11300646|NCT03038399|BG000|Baseline|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily"
11300647|NCT03038399|BG001|Baseline|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily"
11300648|NCT03038399|BG002|Baseline|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily"
11300649|NCT03038399|BG003|Baseline|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily"
11300650|NCT03038399|BG004|Baseline|Total|Total of all reporting groups
11300651|NCT03038399|FG000|Participant Flow|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily"
11300652|NCT03038399|FG001|Participant Flow|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily"
11300653|NCT03038399|FG002|Participant Flow|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily"
11300654|NCT03038399|FG003|Participant Flow|Dose Level Group 4|"Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily"
11300655|NCT03038399|OG000|Outcome|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily"
11300656|NCT03038399|OG001|Outcome|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily"
11300657|NCT03038399|OG002|Outcome|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily"
11300658|NCT03038399|OG003|Outcome|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day.~Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily"
11300659|NCT03038399|OG004|Outcome|Dose Level Group 5|"Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily"
11300660|NCT03038399|EG000|Reported Event|Dose Level Group 1|"Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day.~Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily"
11300661|NCT03038399|EG001|Reported Event|Dose Level Group 2|"Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day.~Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily"
11300662|NCT03038399|EG002|Reported Event|Dose Level Group 3|"Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day.~Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily"
11300663|NCT03038399|EG003|Reported Event|Dose Level Group 4|"Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day.~Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily"
11300664|NCT03038399|EG004|Reported Event|Dose Level Group 5|"Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day.~Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily"
11300665|NCT03038620|BG000|Baseline|Liraglutide 3.0 mg|"Drug: Liraglutide Active Drug~Other Names:~Saxenda~Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300666|NCT03038620|BG001|Baseline|Placebo|"Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL~Other Names:~Placebo~Saline injection~Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300667|NCT03038620|BG002|Baseline|Total|Total of all reporting groups
11300668|NCT03038620|FG000|Participant Flow|Liraglutide 3.0 mg|"Drug: Liraglutide Active Drug~Other Names:~Saxenda~Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300669|NCT03038620|FG001|Participant Flow|Placebo|"Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL~Other Names:~Placebo~Saline injection~Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300670|NCT03038620|OG000|Outcome|Liraglutide 3.0 mg|"Drug: Liraglutide Active Drug~Other Names:~Saxenda~Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300671|NCT03038620|OG001|Outcome|Placebo|"Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL~Other Names:~Placebo~Saline injection~Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300672|NCT03038620|EG000|Reported Event|Liraglutide 3.0 mg|"Drug: Liraglutide Active Drug~Other Names:~Saxenda~Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11341900|NCT03691948|FG000|Participant Flow|ROPEs|Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
11341901|NCT03691948|FG001|Participant Flow|Control|Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
11300673|NCT03038620|EG001|Reported Event|Placebo|"Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL~Other Names:~Placebo~Saline injection~Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.~Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day."
11300674|NCT03038815|BG000|Baseline|Control Group-VACOped-Ortho Tri-Phase|"All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.~This group had the VACUped as first intervention."
11300675|NCT03038815|BG001|Baseline|Control Group-Ortho Tri-Phase-VACOped|"All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.~This group had the Ortho Tri as first intervention."
11300676|NCT03038815|BG002|Baseline|Total|Total of all reporting groups
11300677|NCT03038815|FG000|Participant Flow|Controll-VACOped-Ortho Tri|VACOped first
11300678|NCT03038815|FG001|Participant Flow|Controll-Ortho Tri-VACOped|Ortho Tri first
11300679|NCT03038815|OG000|Outcome|Control Group|All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
11300680|NCT03038815|OG001|Outcome|VACOped|"All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.~VACOped: restriction of ankle joint motion"
11300681|NCT03038815|OG002|Outcome|Ortho Tri-Phase|"All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.~Ortho Tri-Phase: restriction of ankle joint motion"
11300682|NCT03038815|EG000|Reported Event|Controll-VACOped-Ortho Tri|This group had first the control condition, than the VACUped intervention and last the Ortho Tri intervention.
11300683|NCT03038815|EG001|Reported Event|Controll-Ortho Tri-VACOped|This group had first the control condition, than the Ortho Tri intervention and last the VACOped intervention.
11300684|NCT03038867|BG000|Baseline|Duloxetine|"Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week~Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week"
11300685|NCT03038867|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week"
11300686|NCT03038867|BG002|Baseline|Total|Total of all reporting groups
11300687|NCT03038867|FG000|Participant Flow|Duloxetine|"Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week~Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week"
11300688|NCT03038867|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week"
11300689|NCT03038867|OG000|Outcome|Duloxetine|"Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week~Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week"
11300690|NCT03038867|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week"
11300691|NCT03038867|EG000|Reported Event|Duloxetine|"Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week~Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week"
11300692|NCT03038867|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week"
11300693|NCT03038880|BG000|Baseline|6 mg Faricimab Q12W|6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
11300694|NCT03038880|BG001|Baseline|6 mg Faricimab Q16W|6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
11300695|NCT03038880|BG002|Baseline|0.5 mg Ranibizumab Q4W|0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
11300696|NCT03038880|BG003|Baseline|Total|Total of all reporting groups
11300697|NCT03038880|FG000|Participant Flow|6 mg Faricimab Q12W|6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
11300698|NCT03038880|FG001|Participant Flow|6 mg Faricimab Q16W|6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
11300699|NCT03038880|FG002|Participant Flow|0.5 mg Ranibizumab Q4W|0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
11300700|NCT03038880|OG000|Outcome|6 mg Faricimab Q12W|6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
11300701|NCT03038880|OG001|Outcome|6 mg Faricimab Q16W|6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
11300702|NCT03038880|OG002|Outcome|0.5 mg Ranibizumab Q4W|0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
11300703|NCT03038880|EG000|Reported Event|6 mg Faricimab Q12W|6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
11300704|NCT03038880|EG001|Reported Event|6 mg Faricimab Q16W|6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
11300705|NCT03038880|EG002|Reported Event|0.5 mg Ranibizumab Q4W|0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
11300706|NCT03039023|BG000|Baseline|Whole Hardboiled Eggs|"Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300707|NCT03039023|BG001|Baseline|Choline Bitartrate Tablets|"Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets"
11300708|NCT03039023|BG002|Baseline|Hardboiled Eggs + Choline Bitartrate Tablets|"Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300709|NCT03039023|BG003|Baseline|Egg Whites + Choline Bitartrate Tablets|"Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded."
11300710|NCT03039023|BG004|Baseline|Phosphatidylcholine Capsules|"Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.~Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source."
11300711|NCT03039023|BG005|Baseline|Total|Total of all reporting groups
11300712|NCT03039023|FG000|Participant Flow|Whole Hardboiled Eggs|"Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300713|NCT03039023|FG001|Participant Flow|Choline Bitartrate Tablets|"Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets"
11300714|NCT03039023|FG002|Participant Flow|Hardboiled Eggs + Choline Bitartrate Tablets|"Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300715|NCT03039023|FG003|Participant Flow|Egg Whites + Choline Bitartrate Tablets|"Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded."
11300716|NCT03039023|FG004|Participant Flow|Phosphatidylcholine Capsules|"Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.~Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source."
11300717|NCT03039023|OG000|Outcome|Whole Hardboiled Eggs|"Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300718|NCT03039023|OG001|Outcome|Choline Bitartrate Tablets|"Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets"
11300719|NCT03039023|OG002|Outcome|Hardboiled Eggs + Choline Bitartrate Tablets|"Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300720|NCT03039023|OG003|Outcome|Egg Whites + Choline Bitartrate Tablets|"Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded."
11300721|NCT03039023|OG004|Outcome|Phosphatidylcholine Capsules|"Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.~Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source."
11300722|NCT03039023|EG000|Reported Event|Whole Hardboiled Eggs|"Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300723|NCT03039023|EG001|Reported Event|Choline Bitartrate Tablets|"Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets"
11300724|NCT03039023|EG002|Reported Event|Hardboiled Eggs + Choline Bitartrate Tablets|"Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source."
11300725|NCT03039023|EG003|Reported Event|Egg Whites + Choline Bitartrate Tablets|"Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.~Choline Bitartrate: 500mg choline bitartrate tablets~Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded."
11300726|NCT03039023|EG004|Reported Event|Phosphatidylcholine Capsules|"Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.~420 mg phosphatidylcholine capsules obtained from a commercial source."
11300727|NCT03039088|BG000|Baseline|Fibromyalgia Patients|"According to the FiRST Questionnaire~Follow-up after 12 weeks after TNF alpha blockers initiation"
11300728|NCT03039088|BG001|Baseline|Not Fibromyalgia Patients|"According to the FiRST Questionnaire~Follow-up after 12 weeks after TNF alpha blockers initiation"
11300729|NCT03039088|BG002|Baseline|Total|Total of all reporting groups
11300730|NCT03039088|FG000|Participant Flow|Fibromyalgia Patients|202 (38.4%) according to the FiRST questionnaire.
11300731|NCT03039088|FG001|Participant Flow|Not Fibromyalgia Patients|324 (61.6%) according to the FiRST questionnaire
11300732|NCT03039088|OG000|Outcome|Fibromyalgia Patients|192 (37.8%) according to the FiRST questionnaire.
11300733|NCT03039088|OG001|Outcome|Not Fibromyalgia Patients|
11300734|NCT03039088|EG000|Reported Event|Fibromyalgia Patients|"According to the FiRST Questionnaire~Follow-up after 12 weeks after TNF alpha blockers initiation"
11300735|NCT03039088|EG001|Reported Event|Not Fibromyalgia Patients|"According to the FiRST Questionnaire~Follow-up after 12 weeks after TNF alpha blockers initiation"
11300736|NCT03039179|BG000|Baseline|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
11300737|NCT03039179|BG001|Baseline|Standard Care|
11300738|NCT03039179|BG002|Baseline|Total|Total of all reporting groups
11300739|NCT03039179|FG000|Participant Flow|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
11300740|NCT03039179|FG001|Participant Flow|Standard Care|Only application of the Walker in the immediate postoperative period.
11300741|NCT03039179|OG000|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
11300742|NCT03039179|OG001|Outcome|Standard Care|
11300743|NCT03039179|EG000|Reported Event|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
11300744|NCT03039179|EG001|Reported Event|Standard Care|
11300745|NCT03039192|BG000|Baseline|Placebo Plus SOC Antidepressant Treatment|Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
11300746|NCT03039192|BG001|Baseline|Esketamine 84 mg Plus SOC Antidepressant Treatment|Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
11300747|NCT03039192|BG002|Baseline|Total|Total of all reporting groups
11300748|NCT03039192|FG000|Participant Flow|Placebo Plus SOC Antidepressant Treatment|Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
11300749|NCT03039192|FG001|Participant Flow|Esketamine 84 mg Plus SOC Antidepressant Treatment|Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
11300750|NCT03039192|OG000|Outcome|Placebo Plus SOC Antidepressant Treatment|Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
11300751|NCT03039192|OG001|Outcome|Esketamine 84 mg Plus SOC Antidepressant Treatment|Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
11300752|NCT03039192|EG000|Reported Event|Placebo Plus SOC Antidepressant Treatment|Subjects self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1 during double blind phase (DB).
11300753|NCT03039192|EG001|Reported Event|Esketamine 84 mg Plus SOC Antidepressant Treatment|Subjects self-administered esketamine 84 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received SOC antidepressant treatment which was initiated or optimized on Day 1 during double blind phase.
11300754|NCT03039283|BG000|Baseline|Nucleus CI532 Cochlear Implant|Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
11300755|NCT03039283|FG000|Participant Flow|Nucleus CI532 Cochlear Implant|Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
11300756|NCT03039283|OG000|Outcome|Nucleus CI532 Cochlear Implant|Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
11300757|NCT03039283|EG000|Reported Event|Nucleus CI532 Cochlear Implant|Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
11300758|NCT03039543|BG000|Baseline|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300759|NCT03039543|BG001|Baseline|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300760|NCT03039543|BG002|Baseline|Total|Total of all reporting groups
11300761|NCT03039543|FG000|Participant Flow|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300762|NCT03039543|FG001|Participant Flow|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300763|NCT03039543|OG000|Outcome|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300764|NCT03039543|OG001|Outcome|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300765|NCT03039543|EG000|Reported Event|Moderate Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300766|NCT03039543|EG001|Reported Event|Deep Neuromuscular Blockade|"During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.~Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.~Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2."
11300767|NCT03039569|BG000|Baseline|Text Messaging|Intervention group received three text messages per week for 12 weeks
11300768|NCT03039569|BG001|Baseline|Control|Control group did not receive text messages
11300769|NCT03039569|BG002|Baseline|Total|Total of all reporting groups
11335863|NCT03557801|BG002|Baseline|Mammography With Community Health Worker (Group)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11335864|NCT03557801|BG003|Baseline|Total|Total of all reporting groups
10971637|NCT00916136|FG001|Participant Flow|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
11300770|NCT03039569|FG000|Participant Flow|Text Messaging|"Participants received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).~Text messaging: The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise). The control group did not receive text messages"
11300771|NCT03039569|FG001|Participant Flow|Control|Participants did not receive text message intervention. This is the measurement-only group
11300772|NCT03039569|OG000|Outcome|Text Messaging|Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
11300773|NCT03039569|OG001|Outcome|Control|Participants will not receive text message intervention. This is the measurement-only group
11300774|NCT03039569|OG000|Outcome|Text Messaging|"Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).~Text messaging: The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise). The control group will not receive text messages"
11300775|NCT03039569|EG000|Reported Event|Text Messaging|Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
11300776|NCT03039569|EG001|Reported Event|Control|Participants will not receive text message intervention. This is the measurement-only group
11300777|NCT03039621|BG000|Baseline|Ergoferon|Ergoferon: Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours.
11300778|NCT03039621|BG001|Baseline|Placebo|Placebo: Placebo using Ergoferon scheme.
11300779|NCT03039621|BG002|Baseline|Total|Total of all reporting groups
11300780|NCT03039621|FG000|Participant Flow|Ergoferon|"1 tablet 3 times a day.~Ergoferon: Inside, orally."
11300781|NCT03039621|FG001|Participant Flow|Placebo|"1 tablet 3 times a day.~Placebo: Inside, orally."
11300782|NCT03039621|OG000|Outcome|Ergoferon|"1 tablet 3 times a day.~Ergoferon: Inside, orally."
11300783|NCT03039621|OG001|Outcome|Placebo|"1 tablet 3 times a day.~Placebo: Inside, orally."
11300784|NCT03039621|EG000|Reported Event|Ergoferon|"1 tablet 3 times a day.~Ergoferon: Inside, orally."
11300785|NCT03039621|EG001|Reported Event|Placebo|"1 tablet 3 times a day.~Placebo: Inside, orally."
11300786|NCT03039686|BG000|Baseline|Placebo|Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300787|NCT03039686|BG001|Baseline|RO7239361 Low Dose|Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300788|NCT03039686|BG002|Baseline|RO7239361 High Dose|Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300789|NCT03039686|BG003|Baseline|Total|Total of all reporting groups
11300790|NCT03039686|FG000|Participant Flow|Placebo|Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300791|NCT03039686|FG001|Participant Flow|RO7239361 Low Dose|Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300792|NCT03039686|FG002|Participant Flow|RO7239361 High Dose|Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300793|NCT03039686|OG000|Outcome|Placebo|Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300794|NCT03039686|OG001|Outcome|RO7239361 Low Dose|Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300795|NCT03039686|OG002|Outcome|RO7239361 High Dose|Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300796|NCT03039686|OG000|Outcome|Placebo DB|Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period.
11300797|NCT03039686|OG001|Outcome|RO7239361 Low Dose DB|Participants received low dose RO7239361 SC on specified days of the 48-week DB period.
11300798|NCT03039686|OG002|Outcome|RO7239361 High Dose DB|Participants received high dose RO7239361 SC on specified days of the 48-week DB period.
10971638|NCT00916136|OG000|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
10971639|NCT00916136|OG001|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
10971640|NCT00916136|EG000|Reported Event|Cutaneous Traction|"Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
10971641|NCT00916136|EG001|Reported Event|Skeletal Traction|"A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
10971642|NCT00916149|BG000|Baseline|No Treatment|Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
10971643|NCT00916149|BG001|Baseline|Levetiracetam|Individuals with epilepsy who will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
10971644|NCT00916149|BG002|Baseline|Lamotrigine|Individuals with primary generalized epilepsy, who will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance.
10971645|NCT00916149|BG003|Baseline|Total|Total of all reporting groups
10971646|NCT00916149|FG000|Participant Flow|No Treatment|Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
10971647|NCT00916149|FG001|Participant Flow|Levetiracetam|Individuals with epilepsy who will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
10971648|NCT00916149|FG002|Participant Flow|Lamotrigine|Individuals with primary generalized epilepsy, who will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance.
10971649|NCT00916149|OG000|Outcome|No Treatment|Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
10971650|NCT00916149|OG001|Outcome|Levetiracetam|Individuals with epilepsy who will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
10971651|NCT00916149|EG000|Reported Event|Levetiracetam|8 individuals with focal-onset epilepsy. These individuals 12will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
10971652|NCT00916149|EG001|Reported Event|Lamotrigine|5 individuals with generalized epilepsy. These individuals will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance.
10971653|NCT00916149|EG002|Reported Event|No Treatment|12 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
10971654|NCT00916279|BG000|Baseline|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971655|NCT00916279|FG000|Participant Flow|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971656|NCT00916279|OG000|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
10971657|NCT00916279|OG000|Outcome|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971658|NCT00916279|OG000|Outcome|Lutonix PTCA Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971659|NCT00916279|OG000|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971660|NCT00916279|EG000|Reported Event|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
10971661|NCT00916305|BG000|Baseline|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
10971662|NCT00916305|BG001|Baseline|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
10971663|NCT00916305|BG002|Baseline|Total|Total of all reporting groups
10971664|NCT00916305|FG000|Participant Flow|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
10971665|NCT00916305|FG001|Participant Flow|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
10971666|NCT00916305|OG000|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
10971667|NCT00916305|OG001|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
11300799|NCT03039686|OG003|Outcome|RO7239361 Low Dose|Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300800|NCT03039686|OG004|Outcome|RO7239361 High Dose Whole Study|Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300801|NCT03039686|OG004|Outcome|RO7239361 High Dose|Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300802|NCT03039686|EG000|Reported Event|Placebo DB|Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period.
11300803|NCT03039686|EG001|Reported Event|RO7239361 Low Dose DB|Participants received low dose RO7239361 SC on specified days of the 48-week DB period.
11300804|NCT03039686|EG002|Reported Event|RO7239361 High Dose DB|Participants received high dose RO7239361 SC on specified days of the 48-week DB period.
11300805|NCT03039686|EG003|Reported Event|Placebo, Then RO7239361 Low Dose OL|Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label (OL) period followed by 24 weeks of follow-up.
11300806|NCT03039686|EG004|Reported Event|Placebo, Then RO7239361 High Dose OL|Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300807|NCT03039686|EG005|Reported Event|RO7239361 Low Dose, Then RO7239361 Low Dose OL|Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
11300808|NCT03039686|EG006|Reported Event|RO7239361 High Dose, Then RO7239361 High Dose OL|Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up
11300809|NCT03039699|BG000|Baseline|Ergoferon|"1 tablet 3 times a day~Ergoferon"
11300810|NCT03039699|BG001|Baseline|Placebo|"1 tablet 3 times a day~Placebo"
11300811|NCT03039699|BG002|Baseline|Total|Total of all reporting groups
11300812|NCT03039699|FG000|Participant Flow|Ergoferon|"Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily.~Ergoferon"
11300813|NCT03039699|FG001|Participant Flow|Placebo|"Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily.~Placebo"
11300814|NCT03039699|OG000|Outcome|Ergoferon|"1 tablet 3 times a day~Ergoferon"
11300815|NCT03039699|OG001|Outcome|Placebo|"1 tablet 3 times a day~Placebo"
11300816|NCT03039699|EG000|Reported Event|Ergoferon|"1 tablet 3 times a day~Ergoferon"
10971668|NCT00916305|EG000|Reported Event|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
11300817|NCT03039699|EG001|Reported Event|Placebo|"1 tablet 3 times a day~Placebo"
11300818|NCT03039738|BG000|Baseline|Telemetry Monitoring Arm|"The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.~Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events."
11300819|NCT03039738|BG001|Baseline|Surveillance Monitoring Arm|"Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.~Vital Sync IM & VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution."
11300820|NCT03039738|BG002|Baseline|Total|Total of all reporting groups
11300821|NCT03039738|FG000|Participant Flow|Telemetry Monitoring Arm|"The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.~Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events."
11300822|NCT03039738|FG001|Participant Flow|Surveillance Monitoring Arm|"Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.~Vital Sync IM & VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution."
11300823|NCT03039738|OG000|Outcome|Telemetry Monitoring (TM) Arm|"The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.~Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events."
11300824|NCT03039738|OG001|Outcome|Surveillance Monitoring (SM) Arm|"Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.~Vital Sync IM & VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution."
11300825|NCT03039738|EG000|Reported Event|Telemetry Monitoring Arm|"The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.~Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events."
11300826|NCT03039738|EG001|Reported Event|Surveillance Monitoring Arm|"Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.~Vital Sync IM & VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution."
11332868|NCT03502798|OG001|Outcome|Scanning a/LCI (Jacobi)|"Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.~A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.)."
11332869|NCT03502798|EG000|Reported Event|Scanning a/LCI (Pilot)|"Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.~The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements."
11332870|NCT03502798|EG001|Reported Event|Scanning a/LCI (Jacobi)|"Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.~A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.)."
11332871|NCT03502915|BG000|Baseline|Nitrous Oxide|"Patients will receive nitrous oxide during the version procedure.~Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device"
11332872|NCT03502915|BG001|Baseline|Oxygen|"Patients will receive placebo (100% oxygen) during the version procedure.~Placebo: 100% oxygen via Nitronox delivery device"
11332873|NCT03502915|BG002|Baseline|Total|Total of all reporting groups
11332874|NCT03502915|FG000|Participant Flow|Nitrous Oxide|"Patients will receive nitrous oxide during the version procedure.~Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device"
11332875|NCT03502915|FG001|Participant Flow|Oxygen|"Patients will receive placebo (100% oxygen) during the version procedure.~Placebo: 100% oxygen via Nitronox delivery device"
11332876|NCT03502915|OG000|Outcome|Nitrous Oxide|"Patients will receive nitrous oxide during the version procedure.~Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device"
11332877|NCT03502915|OG001|Outcome|Oxygen|"Patients will receive placebo (100% oxygen) during the version procedure.~Placebo: 100% oxygen via Nitronox delivery device"
11332878|NCT03502915|EG000|Reported Event|Nitrous Oxide|"Patients will receive nitrous oxide during the version procedure.~Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device"
11332879|NCT03502915|EG001|Reported Event|Oxygen|"Patients will receive placebo (100% oxygen) during the version procedure.~Placebo: 100% oxygen via Nitronox delivery device"
11332880|NCT03502941|BG000|Baseline|EAAs/Whey: 6.3g First, Then 12.6g|Subjects will consume 6.3 g of EAAs/whey in ~12 oz water on 1 day. Then washout at least 5 days. Then consume 12.6 g of study product at another visit.
11332881|NCT03502941|BG001|Baseline|EAAs/Whey: 12.6g First, Then 6.3g|Subjects will consume 12.6 g of EAAs/whey in ~12 oz water on 1 day. Then washout at least 5 days. Then consume 6.3 g of study product at another visit.
11332882|NCT03502941|BG002|Baseline|Whey Protein Alone|Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
11332883|NCT03502941|BG003|Baseline|Total|Total of all reporting groups
11332884|NCT03502941|FG000|Participant Flow|EAAs/Whey (6.3 g Dose First, Then 12.6g)|Subjects will consume 6.3 g of EAAs/whey in ~12 oz water at their first intervention visit, then 12.6 g of the same product at their second intervention visit.
11332885|NCT03502941|FG001|Participant Flow|EAAs/Whey (12.6g First, Then 6.3g)|Subjects will consume 12.6 g of EAAs/whey in ~12 oz water at their first intervention visit, then 6.3 g of the same product at their second intervention visit.
11332886|NCT03502941|FG002|Participant Flow|Whey Protein Alone|"Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.~12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey"
11332887|NCT03502941|OG000|Outcome|A Single Dose of EAAs/Whey|"Subjects will consume 6.3 g of EAAs/whey in ~12 oz water.~6.3 g of EAAs mixture and whey protein isolate: A single dose of the mixture of EAAs/whey"
11300827|NCT03040011|BG000|Baseline|Bupivacaine/Dexamethasone Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.~Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam"
11300828|NCT03040011|BG001|Baseline|Bupivacaine Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m"
11300829|NCT03040011|BG002|Baseline|Placebo Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx"
11300830|NCT03040011|BG003|Baseline|Total|Total of all reporting groups
11300831|NCT03040011|FG000|Participant Flow|Bupivacaine/Dexamethasone Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.~Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam"
11300832|NCT03040011|FG001|Participant Flow|Bupivacaine Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m"
11300833|NCT03040011|FG002|Participant Flow|Placebo Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx"
11300834|NCT03040011|OG000|Outcome|Bupivacaine/Dexamethasone Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.~Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam"
11332888|NCT03502941|OG001|Outcome|A Double Dose of EAAs/Whey|"Subjects will consume 12.6 g of EAAs/whey in ~12 oz water~12.6 g of EAAs mixture and whey protein isolate: A double dose of the mixture of EAAs/whey"
11300835|NCT03040011|OG001|Outcome|Bupivacaine Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m"
11300836|NCT03040011|OG002|Outcome|Placebo Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx"
11300837|NCT03040011|EG000|Reported Event|Bupivacaine/Dexamethasone Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.~Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam"
11300838|NCT03040011|EG001|Reported Event|Bupivacaine Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.~Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m"
11300839|NCT03040011|EG002|Reported Event|Placebo Arm|"After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.~Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx"
11300840|NCT03040024|BG000|Baseline|Ketamine 0.5 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300841|NCT03040024|BG001|Baseline|Ketamine 1.0 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300842|NCT03040024|BG002|Baseline|Placebo|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.~Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
10971669|NCT00916305|EG001|Reported Event|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
11300843|NCT03040024|BG003|Baseline|Total|Total of all reporting groups
11300844|NCT03040024|FG000|Participant Flow|Ketamine 0.5 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300845|NCT03040024|FG001|Participant Flow|Ketamine 1.0 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300846|NCT03040024|FG002|Participant Flow|Placebo|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.~Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300847|NCT03040024|OG000|Outcome|Ketamine 0.5 mg/kg|"Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.~Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300848|NCT03040024|OG001|Outcome|Ketamine 1.0 mg/kg|"Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.~Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300849|NCT03040024|OG002|Outcome|Placebo|"Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.~Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300850|NCT03040024|EG000|Reported Event|Ketamine 0.5 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300851|NCT03040024|EG001|Reported Event|Ketamine 1.0 mg/kg|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.~Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300852|NCT03040024|EG002|Reported Event|Placebo|"Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.~Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.~Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium."
11300853|NCT03040154|BG000|Baseline|Intervention Arm|"Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders~Video Documentary entitled, Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"
11300854|NCT03040154|BG001|Baseline|Control Arm|"Usual care video publicly available describing the evidence-based parenting intervention~Usual Care Video that is publicly available"
11300855|NCT03040154|BG002|Baseline|Total|Total of all reporting groups
10848378|NCT00289783|FG001|Participant Flow|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11300856|NCT03040154|FG000|Participant Flow|Intervention Arm|"Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders~Video Documentary entitled, Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"
11300857|NCT03040154|FG001|Participant Flow|Control Arm|"Usual care video publicly available describing the evidence-based parenting intervention~Usual Care Video that is publicly available"
11300858|NCT03040154|OG000|Outcome|Intervention Arm|"Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders~Video Documentary entitled, Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"
11300859|NCT03040154|OG001|Outcome|Control Arm|"Usual care video publicly available describing the evidence-based parenting intervention~Usual Care Video that is publicly available"
11300860|NCT03040154|EG000|Reported Event|Intervention Arm|"Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders~Video Documentary entitled, Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"
11300861|NCT03040154|EG001|Reported Event|Control Arm|"Usual care video publicly available describing the evidence-based parenting intervention~Usual Care Video that is publicly available"
11300862|NCT03040336|BG000|Baseline|Prehabilitation|"Standard of care + Prehabilitation~Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation."
11300863|NCT03040336|BG001|Baseline|Standard of Care|Patient received the standard hospital care
11300864|NCT03040336|BG002|Baseline|Total|Total of all reporting groups
11300865|NCT03040336|FG000|Participant Flow|Prehabilitation|"Standard of care + Prehabilitation~Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation."
11300866|NCT03040336|FG001|Participant Flow|Standard of Care|Patient received the standard hospital care
11300867|NCT03040336|OG000|Outcome|Approached|Patients approached to participate.
11300868|NCT03040336|OG000|Outcome|Prehabilitation|"Standard of care + Prehabilitation~Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation."
11300869|NCT03040336|OG001|Outcome|Standard of Care|Patient received the standard hospital care
11300870|NCT03040336|EG000|Reported Event|Prehabilitation|"Standard of care + Prehabilitation~Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation."
11300871|NCT03040336|EG001|Reported Event|Standard of Care|Patient received the standard hospital care
11300872|NCT03040362|BG000|Baseline|[14C]-Lasmiditan|Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.
11300873|NCT03040362|FG000|Participant Flow|[14C]-Lasmiditan|Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.
11300874|NCT03040362|OG000|Outcome|[14C]-Lasmiditan|Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.
11300875|NCT03040362|EG000|Reported Event|[14C]-Lasmiditan|Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.
11300876|NCT03040414|BG000|Baseline|PID Algorithm First, Then PID + Fuzzy Logic Algorithm|"Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.~MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3)."
11300877|NCT03040414|BG001|Baseline|PID + Fuzzy Logic Algorithm First, Then PID Algorithm|"Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.~Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3)."
11300878|NCT03040414|BG002|Baseline|Total|Total of all reporting groups
10848379|NCT00289783|OG000|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11300879|NCT03040414|FG000|Participant Flow|PID Algorithm First, Then PID + Fuzzy Logic Algorithm|"Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.~MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3)."
11300880|NCT03040414|FG001|Participant Flow|PID + Fuzzy Logic Algorithm First, Then PID Algorithm|"Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.~Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3)."
11300881|NCT03040414|OG000|Outcome|PID Algorithm|"Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.~MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3)."
11300882|NCT03040414|OG001|Outcome|PID + Fuzzy Logic Algorithm|"Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.~Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3)."
11300883|NCT03040414|EG000|Reported Event|PID Algorithm|"Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.~MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3)."
11300884|NCT03040414|EG001|Reported Event|PID + Fuzzy Logic Algorithm|"Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.~Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3)."
11300885|NCT03040427|BG000|Baseline|At Risk for Symptomatic AL Cardiac Amyloidosis|Patients with MGUS at risk for developing AL amyloidosis
11300886|NCT03040427|BG001|Baseline|At Risk for Symptomatic ATTR Cardiac Amyloidosis|Patients with biopsy proven extra-cardiac ATTR amyloidosis
11300887|NCT03040427|BG002|Baseline|Control Patients|Negative carpal tunnel biopsy
11300888|NCT03040427|BG003|Baseline|Total|Total of all reporting groups
11300889|NCT03040427|FG000|Participant Flow|At Risk for Symptomatic AL Cardiac Amyloidosis|Patients with MGUS at risk for developing AL amyloidosis
11300890|NCT03040427|FG001|Participant Flow|At Risk for Symptomatic ATTR Cardiac Amyloidosis|Patients with biopsy proven extra-cardiac ATTR amyloidosis
11300891|NCT03040427|FG002|Participant Flow|Control Patients|Negative carpal tunnel biopsy
11300892|NCT03040427|OG000|Outcome|At Risk for Symptomatic AL Cardiac Amyloidosis|Patients with MGUS at risk for developing AL amyloidosis
11300893|NCT03040427|OG001|Outcome|At Risk for Symptomatic ATTR Cardiac Amyloidosis|Patients with biopsy proven extra-cardiac ATTR amyloidosis
11300894|NCT03040427|OG002|Outcome|Control Patients|Negative carpal tunnel biopsy
11300895|NCT03040427|EG000|Reported Event|At Risk for Symptomatic AL Cardiac Amyloidosis|Patients with MGUS at risk for developing AL amyloidosis
11300896|NCT03040427|EG001|Reported Event|At Risk for Symptomatic ATTR Cardiac Amyloidosis|Patients with biopsy proven extra-cardiac ATTR amyloidosis
11300897|NCT03040427|EG002|Reported Event|Control Patients|Negative carpal tunnel biopsy
10848380|NCT00289783|OG001|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11300898|NCT03040466|BG000|Baseline|Reusable Fiberoptic Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones."
11300899|NCT03040466|BG001|Baseline|Disposable Digital Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones."
11300900|NCT03040466|BG002|Baseline|Total|Total of all reporting groups
11300901|NCT03040466|FG000|Participant Flow|Reusable Fiberoptic Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones."
11300902|NCT03040466|FG001|Participant Flow|Disposable Digital Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones."
11300903|NCT03040466|OG000|Outcome|Reusable Fiberoptic Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones."
11300904|NCT03040466|OG001|Outcome|Disposable Digital Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones."
11300905|NCT03040466|EG000|Reported Event|Reusable Fiberoptic Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones."
11300906|NCT03040466|EG001|Reported Event|Disposable Digital Ureteroscope|"For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.~disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones."
11300907|NCT03040479|BG000|Baseline|Mild Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300908|NCT03040479|BG001|Baseline|Moderate Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300909|NCT03040479|BG002|Baseline|Healthy Participants|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300910|NCT03040479|BG003|Baseline|Total|Total of all reporting groups
11300911|NCT03040479|FG000|Participant Flow|Mild Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300912|NCT03040479|FG001|Participant Flow|Moderate Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300913|NCT03040479|FG002|Participant Flow|Healthy Participants|Participants received lasmiditan 200 mg single oral dose in the fasting state.
10848381|NCT00289783|OG002|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
10971670|NCT00916344|BG000|Baseline|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
11300914|NCT03040479|OG000|Outcome|Mild Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300915|NCT03040479|OG001|Outcome|Moderate Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state
11300916|NCT03040479|OG002|Outcome|Healthy Participants|Participants received lasmiditan 200 mg single oral dose in the fasting state
11300917|NCT03040479|OG001|Outcome|Moderate Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300918|NCT03040479|OG002|Outcome|Healthy Participants|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300919|NCT03040479|EG000|Reported Event|Mild Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300920|NCT03040479|EG001|Reported Event|Moderate Hepatic Impairment|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300921|NCT03040479|EG002|Reported Event|Healthy Participants|Participants received lasmiditan 200 mg single oral dose in the fasting state.
11300922|NCT03040674|BG000|Baseline|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day"
11300923|NCT03040674|FG000|Participant Flow|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive autologous cellular therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood. After harvest, cells are processed using minimal manipulation for platelet-rich plasma/ platelet concentrate (from peripheral blood) and/or mesenchymal stem cells (from bone marrow) and returned to the patient via peripheral circulation on the same day."
11300924|NCT03040674|OG000|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive autologous cellular therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood. After harvest, cells are processed using minimal manipulation for platelet-rich plasma/ platelet concentrate (from peripheral blood) and/or mesenchymal stem cells (from bone marrow) and returned to the patient via peripheral circulation on the same day."
11300925|NCT03040674|OG000|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day"
11300926|NCT03040674|EG000|Reported Event|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day"
11300927|NCT03040687|BG000|Baseline|Anti-CS6 Group|"Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti CS6 BSIgG product (Lot PD1601105CS)~B7A- CS6-expressing ETEC challenge strain"
11300928|NCT03040687|BG001|Baseline|Anti-whole Cell B7A|"Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti B7A BSIgG product (Lot PD1601132ET)~B7A- CS6-expressing ETEC challenge strain"
11300929|NCT03040687|BG002|Baseline|Control Immunoglobulin Group|"Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)~Bovine Immunoglobin Negative Control (Lot PD161071NC)~B7A- CS6-expressing ETEC challenge strain"
11300930|NCT03040687|BG003|Baseline|Total|Total of all reporting groups
11300931|NCT03040687|FG000|Participant Flow|Anti-CS6 Group|"Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti CS6 BSIgG product (Lot PD1601105CS)~B7A- CS6-expressing ETEC challenge strain"
11300932|NCT03040687|FG001|Participant Flow|Anti-whole Cell B7A|"Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti B7A BSIgG product (Lot PD1601132ET)~B7A- CS6-expressing ETEC challenge strain"
11300933|NCT03040687|FG002|Participant Flow|Control Immunoglobulin Group|"Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)~Bovine Immunoglobin Negative Control (Lot PD161071NC)~B7A- CS6-expressing ETEC challenge strain"
11300934|NCT03040687|OG000|Outcome|Anti-CS6 Group|"Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti CS6 BSIgG product (Lot PD1601105CS)~B7A- CS6-expressing ETEC challenge strain"
11300935|NCT03040687|OG001|Outcome|Anti-whole Cell B7A|"Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti B7A BSIgG product (Lot PD1601132ET)~B7A- CS6-expressing ETEC challenge strain"
11300936|NCT03040687|OG002|Outcome|Control Immunoglobulin Group|"Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)~Bovine Immunoglobin Negative Control (Lot PD161071NC)~B7A- CS6-expressing ETEC challenge strain"
11300937|NCT03040687|EG000|Reported Event|Anti-CS6 Group|"Anti-CS6 BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti CS6 BSIgG product (Lot PD1601105CS)~B7A- CS6-expressing ETEC challenge strain"
11300938|NCT03040687|EG001|Reported Event|Anti-whole Cell B7A|"Anti- whole cell B7A (killed) BSIgG and challenge strain CS6-expressing ETEC (B7A)~Anti B7A BSIgG product (Lot PD1601132ET)~B7A- CS6-expressing ETEC challenge strain"
11300939|NCT03040687|EG002|Reported Event|Control Immunoglobulin Group|"Negative Control (Nonhyperimmune BSIgG placebo) and challenge strain CS6-expressing ETEC (B7A)~Bovine Immunoglobin Negative Control (Lot PD161071NC)~B7A- CS6-expressing ETEC challenge strain"
11300940|NCT03040713|BG000|Baseline|FTD Subjects|Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan
11300941|NCT03040713|FG000|Participant Flow|FTD Subjects|Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan
11300942|NCT03040713|OG000|Outcome|FTD Subjects|Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan
11300943|NCT03040713|EG000|Reported Event|FTD Subjects Safety Population|Subjects diagnosed with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan
11300944|NCT03040804|BG000|Baseline|Low Dose Radiotherapy|"Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week~Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy."
11300945|NCT03040804|FG000|Participant Flow|Low Dose Radiotherapy|"Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week~Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy."
11300946|NCT03040804|OG000|Outcome|Low Dose Radiotherapy|"Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week~Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy."
11300947|NCT03040804|EG000|Reported Event|Low Dose Radiotherapy|"Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week~Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.~No adverse event reported to date."
11300948|NCT03040986|BG000|Baseline|Dose Level 0: 75mg Selumetinib Sulfate Twice Daily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300949|NCT03040986|BG001|Baseline|75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID) followed by 50mg twice daily. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300950|NCT03040986|BG002|Baseline|Total|Total of all reporting groups
10971671|NCT00916344|FG000|Participant Flow|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
11300951|NCT03040986|FG000|Participant Flow|Dose Level 0: 75mg Selumetinib Sulfate Twice Daily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300952|NCT03040986|FG001|Participant Flow|75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID) followed by 50mg twice daily. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300953|NCT03040986|OG000|Outcome|Dose Level 0: 75mg Selumetinib Sulfate Twice Daily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300954|NCT03040986|OG001|Outcome|75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID) followed by 50mg twice daily. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300955|NCT03040986|OG000|Outcome|All Participants|All participants that received 75mg selumetinib sulfate by mouth (PO) twice daily (BID); and 75mg Selumetinib sulfate twice daily followed by 50mg twice daily.
11300956|NCT03040986|OG000|Outcome|Probably Attributable: 75mg Selumetinib Sulfate Twice Daily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300957|NCT03040986|EG000|Reported Event|Dose Level 0: 75mg Selumetinib Sulfate Twice Daily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300958|NCT03040986|EG001|Reported Event|75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily|Participants receive 75mg selumetinib sulfate by mouth (PO) twice daily (BID) followed by 50mg twice daily. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
11300959|NCT03041025|BG000|Baseline|Placebo|Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300960|NCT03041025|BG001|Baseline|GSK2330811 100 mg|Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300961|NCT03041025|BG002|Baseline|GSK2330811 300 mg|Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300962|NCT03041025|BG003|Baseline|Total|Total of all reporting groups
11300963|NCT03041025|FG000|Participant Flow|Placebo|Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300964|NCT03041025|FG001|Participant Flow|GSK2330811 100 mg|Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300965|NCT03041025|FG002|Participant Flow|GSK2330811 300 mg|Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300966|NCT03041025|OG000|Outcome|Placebo|Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300967|NCT03041025|OG001|Outcome|GSK2330811 100 mg|Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300968|NCT03041025|OG002|Outcome|GSK2330811 300 mg|Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300969|NCT03041025|OG000|Outcome|GSK2330811 100 mg|Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300970|NCT03041025|OG001|Outcome|GSK2330811 300 mg|Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300971|NCT03041025|OG000|Outcome|GSK2330811 100 mg and GSK2330811 300 mg - Overall|Participants received subcutaneous injection of GSK2330811 100 mg and 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300972|NCT03041025|EG000|Reported Event|Placebo|Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300973|NCT03041025|EG001|Reported Event|GSK2330811 100 mg|Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300974|NCT03041025|EG002|Reported Event|GSK2330811 300 mg|Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).
11300975|NCT03041038|BG000|Baseline|Secukinumab|"Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial~Secukinumab: Anti IL-17A antibody"
11300976|NCT03041038|BG001|Baseline|Placebo|"Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial~Placebo"
11300977|NCT03041038|BG002|Baseline|Total|Total of all reporting groups
11300978|NCT03041038|FG000|Participant Flow|Secukinumab|"Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial~Secukinumab: Anti IL-17A antibody"
11300979|NCT03041038|FG001|Participant Flow|Placebo|"Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial~Placebo"
11300980|NCT03041038|OG000|Outcome|Secukinumab|"Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial~Secukinumab: Anti IL-17A antibody"
11300981|NCT03041038|OG001|Outcome|Placebo|"Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial~Placebo"
11300982|NCT03041038|OG002|Outcome|Open Label|Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
11300983|NCT03041038|EG000|Reported Event|Secukinumab|"Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial~Secukinumab: Anti IL-17A antibody"
11300984|NCT03041038|EG001|Reported Event|Placebo|"Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial~Placebo"
11300985|NCT03041038|EG002|Reported Event|Open Label|Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
11300986|NCT03041090|BG000|Baseline|Dynamic Arm|Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. During the 60 minute uptake, these subjects were scanned. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. Dynamic arm (n=24 where 21 were analyzed) had 3 subjects that could not be analyzed due to technical errors, so 21 subjects were analyzed from this arm. Age and gender were not considered confounding factors and were not collected as part of the clinical study.
11332889|NCT03502941|OG002|Outcome|Whey Protein Alone|"Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.~12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey"
11332890|NCT03502941|EG000|Reported Event|A Single Dose of EAAs/Whey|"Subjects will consume 6.3 g of EAAs/whey in ~12 oz water.~6.3 g of EAAs mixture and whey protein isolate: A single dose of the mixture of EAAs/whey"
11332891|NCT03502941|EG001|Reported Event|A Double Dose of EAAs/Whey|"Subjects will consume 12.6 g of EAAs/whey in ~12 oz water~12.6 g of EAAs mixture and whey protein isolate: A double dose of the mixture of EAAs/whey"
11300987|NCT03041090|BG001|Baseline|Static Arm|Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. The static arm included 109 subjects. Age and gender were not considered confounding factors and were not collected as part of the clinical study.
11300988|NCT03041090|BG002|Baseline|Total|Total of all reporting groups
11300989|NCT03041090|FG000|Participant Flow|Static Imaging Participants|This arm of the study assessed participants' static Positron Emission Tomography / Computed Tomography (PET/CT) images. These were the standard of care images acquired after their standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data. This arm also visually assessed the images at the injection site by a board certified physician.
11300990|NCT03041090|FG001|Participant Flow|Dynamic Image Participants|This arm of the study assessed participants' dynamic Positron Emission Tomography / Computed Tomography (PET/CT) images. These were the study related images of and around the injection site acquired during the participants' standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data. This arm also visually assessed the images at the injection site by a board certified physician.
11300991|NCT03041090|OG000|Outcome|Dynamic Arm|This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.
11300992|NCT03041090|OG001|Outcome|Static Arm|This arm includes the study participants that participated in static image acquisition.
11300993|NCT03041090|EG000|Reported Event|Dynamic Arm|This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.
11300994|NCT03041090|EG001|Reported Event|Static Arm|This arm includes the study participants that participated in static image acquisition.
11300995|NCT03041116|BG000|Baseline|Fosmetpantotenate|"Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required."
11300996|NCT03041116|BG001|Baseline|Placebo|"Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required."
11300997|NCT03041116|BG002|Baseline|Total|Total of all reporting groups
11300998|NCT03041116|FG000|Participant Flow|Fosmetpantotenate|"Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose 3 times daily (TID) from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required."
11300999|NCT03041116|FG001|Participant Flow|Placebo|"Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required."
10971672|NCT00916344|OG000|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
10971673|NCT00916344|EG000|Reported Event|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
11301000|NCT03041116|OG000|Outcome|Fosmetpantotenate|"Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required."
11301001|NCT03041116|OG001|Outcome|Placebo|"Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required."
11301002|NCT03041116|EG000|Reported Event|Fosmetpantotenate|"Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.~Includes data over the entire study for those who completed the double-blind period and entered the open-label period."
11301003|NCT03041116|EG001|Reported Event|Placebo|"Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.~Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.~Includes data over the entire study for those who completed the double-blind period and entered the open-label period."
11301004|NCT03041116|EG002|Reported Event|Fosmetpantotenate During Double-blind Period|Double-blind Period: each randomized participant received oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.
11301005|NCT03041116|EG003|Reported Event|Placebo During Double-blind Period|Double-blind Period: each randomized participant received oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.
11301006|NCT03041116|EG004|Reported Event|Fosmetpantotenate During Open-label Period|Open-label Period: at Week 25, all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.
11301007|NCT03041116|EG005|Reported Event|Placebo During Open-label Period|Open-label Period: at Week 25, all participants started treatment with fosmetpantotenate according to the placebo-matched dose they were receiving at the end of the double-blind period. No dose escalation was required.
11301008|NCT03041181|BG000|Baseline|Arm A|"Single Agent Chemotherapy of choice plus nivolumab:~Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301009|NCT03041181|BG001|Baseline|Arm B|"Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301010|NCT03041181|BG002|Baseline|Total|Total of all reporting groups
11301011|NCT03041181|FG000|Participant Flow|Arm A - Single Agent Chemotherapy + Nivolumab|"Single Agent Chemotherapy of choice plus nivolumab:~Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301012|NCT03041181|FG001|Participant Flow|Arm B - Single Agent Chemotherapy|"Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301013|NCT03041181|OG000|Outcome|Arm A|"Single Agent Chemotherapy of choice plus nivolumab:~Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301014|NCT03041181|OG001|Outcome|Arm B|"Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301015|NCT03041181|EG000|Reported Event|Arm A|"Single Agent Chemotherapy of choice plus nivolumab:~Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301016|NCT03041181|EG001|Reported Event|Arm B|"Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine~Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)~Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)~Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)"
11301017|NCT03041298|BG000|Baseline|All Included Patients|All included patients underwent MR mammography with Dotarem.
11301018|NCT03041298|FG000|Participant Flow|All Included Patients|All included patients underwent MR mammography with Dotarem.
11301019|NCT03041298|OG000|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
11301020|NCT03041298|EG000|Reported Event|All Included Patients|All included patients underwent MR mammography with Dotarem.
11301021|NCT03041441|BG000|Baseline|MRICP Method|"MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion~Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.~Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan"
11301022|NCT03041441|FG000|Participant Flow|MRICP Method|"MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion~Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.~Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan"
11301023|NCT03041441|OG000|Outcome|MRICP Method|"MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.~MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion~Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.~Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan"
10848382|NCT00289783|OG003|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11301024|NCT03041441|OG000|Outcome|MRICP Method|"MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion~Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.~Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan"
11301025|NCT03041441|EG000|Reported Event|MRICP Method|"MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.~MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion~Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.~Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan"
11301026|NCT03041467|BG000|Baseline|IN.PACT AV DCB|"PTA will be performed using the IN.PACT AV Drug Coated Balloon.~IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon"
11301027|NCT03041467|BG001|Baseline|Standard Balloon Angioplasty|"PTA will be performed using a commercially available uncoated PTA balloon.~Standard Balloon Angioplasty: Standard PTA Balloon"
11301028|NCT03041467|BG002|Baseline|Total|Total of all reporting groups
11301029|NCT03041467|FG000|Participant Flow|IN.PACT AV DCB|"PTA will be performed using the IN.PACT AV Drug Coated Balloon.~IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon"
11301030|NCT03041467|FG001|Participant Flow|Standard Balloon Angioplasty|"PTA will be performed using a commercially available uncoated PTA balloon.~Standard Balloon Angioplasty: Standard PTA Balloon"
11301031|NCT03041467|OG000|Outcome|IN.PACT AV DCB|"PTA will be performed using the IN.PACT AV Drug Coated Balloon.~IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon"
10848383|NCT00289783|OG004|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11301032|NCT03041467|OG001|Outcome|Standard Balloon Angioplasty|"PTA will be performed using a commercially available uncoated PTA balloon.~Standard Balloon Angioplasty: Standard PTA Balloon"
11301033|NCT03041467|OG000|Outcome|IN.PACT AV DCB|"PTA was performed using the IN.PACT AV Drug Coated Balloon.~IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon"
11301034|NCT03041467|OG001|Outcome|Standard Balloon Angioplasty|"PTA was performed using a commercially available uncoated PTA balloon.~Standard Balloon Angioplasty: Standard PTA Balloon"
11301035|NCT03041467|EG000|Reported Event|IN.PACT AV DCB|"PTA will be performed using the IN.PACT AV Drug Coated Balloon.~IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon"
11301036|NCT03041467|EG001|Reported Event|Standard Balloon Angioplasty|"PTA will be performed using a commercially available uncoated PTA balloon.~Standard Balloon Angioplasty: Standard PTA Balloon"
11301037|NCT03041636|BG000|Baseline|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.~Ruxolitinib: Given PO~Ruxolitinib Phosphate: Given PO"
11301038|NCT03041636|FG000|Participant Flow|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO twice a daily (BID). Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.~Ruxolitinib: Given PO~Ruxolitinib Phosphate: Given PO"
11301039|NCT03041636|OG000|Outcome|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.~Ruxolitinib: Given PO~Ruxolitinib Phosphate: Given PO"
11301040|NCT03041636|EG000|Reported Event|Treatment (Ruxolitinib Phosphate)|"Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.~Ruxolitinib: Given PO~Ruxolitinib Phosphate: Given PO"
11301041|NCT03041792|BG000|Baseline|Liraglutide|Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
11301042|NCT03041792|BG001|Baseline|Placebo|0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
11301043|NCT03041792|BG002|Baseline|Total|Total of all reporting groups
11301044|NCT03041792|FG000|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
11301045|NCT03041792|FG001|Participant Flow|Placebo|0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
11301046|NCT03041792|OG000|Outcome|Liraglutide|Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
11301047|NCT03041792|OG001|Outcome|Placebo|0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
11301048|NCT03041792|EG000|Reported Event|Liraglutide|Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
11301049|NCT03041792|EG001|Reported Event|Placebo|0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
11301050|NCT03041896|BG000|Baseline|Decompression|"Standard of care decompression for spinal stenosis, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301051|NCT03041896|BG001|Baseline|Fusion|"Standard pedical and rod fixation with standard decompression, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301052|NCT03041896|BG002|Baseline|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301053|NCT03041896|BG003|Baseline|Hybrid|coflex and fusion at adjacent levels
11301054|NCT03041896|BG004|Baseline|Total|Total of all reporting groups
11301055|NCT03041896|FG000|Participant Flow|Decompression|"Standard of care decompression for spinal stenosis, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301056|NCT03041896|FG001|Participant Flow|Fusion|"Standard pedical and rod fixation with standard decompression, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301057|NCT03041896|FG002|Participant Flow|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301058|NCT03041896|FG003|Participant Flow|Hybrid|coflex and fusion at adjacent levels
11301059|NCT03041896|OG000|Outcome|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301060|NCT03041896|OG001|Outcome|Decompression|"Standard of care decompression for spinal stenosis, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301061|NCT03041896|OG000|Outcome|Decompression|"Standard of care decompression for spinal stenosis, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301062|NCT03041896|OG001|Outcome|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301063|NCT03041896|OG002|Outcome|Fusion|Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
11301064|NCT03041896|OG001|Outcome|Fusion|"Standard pedical and rod fixation with standard decompression, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301065|NCT03041896|OG002|Outcome|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301066|NCT03041896|OG003|Outcome|Hybrid|"coflex and fusion at adjacent levels~coflex® Interlaminar Technology: Interlaminer Technology"
11301067|NCT03041896|EG000|Reported Event|Decompression|"Standard of care decompression for spinal stenosis, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301068|NCT03041896|EG001|Reported Event|Fusion|"Standard pedical and rod fixation with standard decompression, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301069|NCT03041896|EG002|Reported Event|Coflex®|"Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.~coflex® Interlaminar Technology: Interlaminer Technology"
11301070|NCT03041896|EG003|Reported Event|Hybrid|coflex and fusion at adjacent levels
11301071|NCT03041909|BG000|Baseline|GBT440 - 2 Months|These subjects received GBT440 for 2 months as these subjects received GBT440 for 4 months in GBT440-001 study (NCT02285088) (n=3).
11301072|NCT03041909|BG001|Baseline|GBT440 - 6 Months|The subject received GBT440 for 6 months as this subject received placebo in GBT440-001 study (NCT02285088) (n=1).
11301073|NCT03041909|BG002|Baseline|GBT440 - 4 Months|This subject received GBT440 for 4 months as the subject received GBT440 for 2 months in GBT440-001 study (NCT02285088) (n=1).
11301074|NCT03041909|BG003|Baseline|Total|Total of all reporting groups
11301075|NCT03041909|FG000|Participant Flow|GBT440 - 2 Months|These subjects received GBT440 for 2 months as these subjects received GBT440 for 4 months in GBT440-001 study (n=3) (NCT02285088).
11301076|NCT03041909|FG001|Participant Flow|GBT440 - 6 Months|The subject received GBT440 for 6 months as this subject received placebo in GBT440-001 study (n=1) (NCT02285088).
11301077|NCT03041909|FG002|Participant Flow|GBT440 - 4 Months|This subject received GBT440 for 4 months as the subject received GBT440 for 2 months in GBT440-001 study (n=1) (NCT02285088).
11301078|NCT03041909|OG000|Outcome|GBT440 - 2 Months|These subjects received GBT440 for 2 months as these subjects received GBT440 for 4 months in GBT440-001 study (n=3) (NCT02285088).
11301079|NCT03041909|OG001|Outcome|GBT440 - 6 Months|The subject received GBT440 for 6 months as this subject received placebo in GBT440-001 study (n=1) (NCT02285088).
11301080|NCT03041909|OG002|Outcome|GBT440 - 4 Months|This subject received GBT440 for 4 months as the subject received GBT440 for 2 months in GBT440-001 study (n=1) (NCT02285088).
11301081|NCT03041909|EG000|Reported Event|GBT440 - 2 Months|These subjects received GBT440 for 2 months as these subjects received GBT440 for 4 months in GBT440-001 study (NCT02285088) (n=3).
11301082|NCT03041909|EG001|Reported Event|GBT440 - 6 Months|The subject received GBT440 for 6 months as this subject received placebo in GBT440-001 study (NCT02285088) (n=1).
11301083|NCT03041909|EG002|Reported Event|GBT440 - 4 Months|This subject received GBT440 for 4 months as the subject received GBT440 for 2 months in GBT440-001 study (NCT02285088) (n=1).
11301084|NCT03042299|BG000|Baseline|TAK-536 Granules + TAK-536 Tablet|TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
11301085|NCT03042299|BG001|Baseline|TAK-536 Tablet + TAK-536 Granules|TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
11301086|NCT03042299|BG002|Baseline|Total|Total of all reporting groups
11301087|NCT03042299|FG000|Participant Flow|TAK-536 Granules + TAK-536 Tablet|TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
11301088|NCT03042299|FG001|Participant Flow|TAK-536 Tablet + TAK-536 Granules|TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
11301089|NCT03042299|OG000|Outcome|TAK-536 10 mg Granules (Pediatric Formulation)|TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
11301090|NCT03042299|OG001|Outcome|TAK-536 10 mg Tablet (Commercial Formulation)|TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
11301091|NCT03042299|EG000|Reported Event|TAK-536 10 mg Granules (Pediatric Formulation)|TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
11301092|NCT03042299|EG001|Reported Event|TAK-536 10 mg Tablet (Commercial Formulation)|TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
11301093|NCT03042312|BG000|Baseline|177Lu-PSMA-617 (6.0 GBq)|Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301094|NCT03042312|BG001|Baseline|177Lu-PSMA-617 (7.4 GBq)|Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301095|NCT03042312|BG002|Baseline|Total|Total of all reporting groups
11301096|NCT03042312|FG000|Participant Flow|177Lu-PSMA-617 (6.0 GBq)|Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301097|NCT03042312|FG001|Participant Flow|177Lu-PSMA-617 (7.4 GBq)|Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301098|NCT03042312|OG000|Outcome|177Lu-PSMA-617 (6.0 GBq)|Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301099|NCT03042312|OG001|Outcome|177Lu-PSMA-617 (7.4 GBq)|Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301100|NCT03042312|EG000|Reported Event|177Lu-PSMA-617 (6.0 GBq)|Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301101|NCT03042312|EG001|Reported Event|177Lu-PSMA-617 (7.4 GBq)|Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
11301102|NCT03042559|BG000|Baseline|Protonics Knee Brace|"Subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.~Protonics Knee brace: Program was separated into three phases for a period of 4 weeks. Each phase the patients learned how to perform the Protonics neuromuscular repositioning technique, Protonics gait and open-chain exercise. Subjects asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.~Phase one, Subjects performed Protonics Neuromuscular repositioning Techniques, walking for up to 5 minutes or as tolerated, and preform warming up exercise.~Phase two, subjects performed Protonics Neuromuscular repositioning Techniques, walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~Phase three, the subjects performed Protonics Neuromuscular repositioning Techniques, walking for up to 10 minutes or as tolerated, and preformed exercise in standing position."
11301103|NCT03042559|BG001|Baseline|Sport Cords|"Resistive sports cord to resist knee flexion.~Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.~In phase one, the subjects will perform the sports cord gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.~In phase two, the subjects will perform the sports cord gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~In phase three, the subjects will perform the sports cord gait through walking for up to 10 minutes or as tolerated, and preform one specific exercise in standing position."
11301104|NCT03042559|BG002|Baseline|Total|Total of all reporting groups
10848384|NCT00289783|OG000|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11332892|NCT03502941|EG002|Reported Event|Whey Protein Alone|"Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.~12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey"
11301105|NCT03042559|FG000|Participant Flow|Protonics Knee Brace|"All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.~Protonics Knee brace: Protonics Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the Protonics neuromuscular repositioning technique, Protonics gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks In phase one, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.~In phase two, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~In phase three, the subjects will perform Protonics exercises."
11301106|NCT03042559|FG001|Participant Flow|Sport Cords|"Resistive sports cord to resist knee flexion.~Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.~In phase one, the subjects will perform the sports cord gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.~In phase two, the subjects will perform the sports cord gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~In phase three, the subjects will perform the sports cord gait through walking for up to 10 minutes or as tolerated, and preform one specific exercise in standing position."
11301107|NCT03042559|OG000|Outcome|Protonics Knee Brace|"All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.~Protonics Knee brace: Protonics Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the Protonics neuromuscular repositioning technique, Protonics gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks In phase one, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.~In phase two, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~In phase three, the subjects will perform Protonics Neuromuscular repositioni"
11301108|NCT03042559|OG001|Outcome|Sport Cords|"Resistive sports cord to resist knee flexion.~Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.~In phase one, the subjects will perform the sports cord gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.~In phase two, the subjects will perform the sports cord gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.~In phase three, the subjects will perform the sports cord gait through walking for up to 10 minutes or as tolerated, and preform one specific exercise in standing position."
11301109|NCT03042559|EG000|Reported Event|Protonics Knee Brace|"All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.~Protonics Knee brace: Protonics Therapy Program is separated into three phases for a period of 4 weeks. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks. Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the .~Protonics Neuromuscular repositioning Technique training,"
11301110|NCT03042559|EG001|Reported Event|Sport Cords|"Resistive sports cord to resist knee flexion.~Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the Sport Cord training,"
11301111|NCT03042702|BG000|Baseline|Kevetrin 250 mg/m2 IV/Cohort 1|"Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends~Kevetrin: Kevetrin dose to associated cohort"
11301112|NCT03042702|FG000|Participant Flow|Kevetrin 250 mg/m2 IV/Cohort 1|"Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends~Kevetrin: Kevetrin dose to associated cohort"
11301113|NCT03042702|OG000|Outcome|Kevetrin 250 mg/m2 IV/Cohort 1|"Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends~Kevetrin: Kevetrin dose to associated cohort"
11301114|NCT03042702|OG000|Outcome|Kevetrin 250 mg/m2 IV Cohort 1|"Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends~Kevetrin: Kevetrin dose to associated cohort"
11341902|NCT03691948|OG000|Outcome|Overall - Intervention and Control Participants|This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.
11341903|NCT03691948|OG000|Outcome|ROPEs|Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
10971674|NCT00916357|BG000|Baseline|Overall Study|Participants who received at least 1 dose of Humalog, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during dose-finding (DV) visits or experimental (data gathering) visits.
11301115|NCT03042702|EG000|Reported Event|Cohort 1|"Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends~Kevetrin: Kevetrin dose to associated cohort"
11301116|NCT03042715|BG000|Baseline|Psychological Intervention Refinement|"Eight weekly sessions in-person or via telephone~Qualitative interviews~Feedback from 5-10 caregivers to refine the intervention.~Qualitative Interviews: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback"
11301117|NCT03042715|FG000|Participant Flow|Qualitative Refinement|this clinical trials.gov report is focused on the qualitative refinement phase of the project.
11301118|NCT03042715|OG000|Outcome|Qualitative Refinement|pilot qualitative refinement of intervention
11301119|NCT03042715|EG000|Reported Event|Qualitative Refinement|this clinical trials.gov report is focused on the qualitative refinement phase of the project.
11301120|NCT03042767|BG000|Baseline|IMM-124E Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.~IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring."
11301121|NCT03042767|BG001|Baseline|Placebo Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.~Placebo: Matched Placebo"
11301122|NCT03042767|BG002|Baseline|Total|Total of all reporting groups
11301123|NCT03042767|FG000|Participant Flow|IMM-124E Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.~IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring."
11301124|NCT03042767|FG001|Participant Flow|Placebo Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.~Placebo: Matched Placebo"
11301125|NCT03042767|OG000|Outcome|IMM-124E Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.~IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring."
11301126|NCT03042767|OG001|Outcome|Placebo Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.~Placebo: Matched Placebo"
11301127|NCT03042767|EG000|Reported Event|IMM-124E Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.~IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring."
11301128|NCT03042767|EG001|Reported Event|Placebo Group|"Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.~Placebo: Matched Placebo"
11301129|NCT03042910|BG000|Baseline|Talazoparib 1 mg QD|Talazoparib capsule was administered orally at 1 mg once daily (QD) for up to 22 days.
11301130|NCT03042910|FG000|Participant Flow|Talazoparib 1 mg QD|Talazoparib capsule was administered orally at 1 mg once daily (QD) for up to 22 days.
11301131|NCT03042910|OG000|Outcome|Talazoparib 1 mg QD|Talazoparib capsule was administered orally at 1 mg once daily (QD) for up to 22 days.
11301132|NCT03042910|EG000|Reported Event|Talazoparib 1 mg QD|Talazoparib capsule was administered orally at 1 mg once daily (QD) for up to 22 days.
11301133|NCT03043079|BG000|Baseline|Ventral Hernia|"Twenty-one patients diagnosed with ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301134|NCT03043079|BG001|Baseline|Healthy Volunteers|"Fourteen volunteers without ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301135|NCT03043079|BG002|Baseline|Active Health Volunteers|"Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301136|NCT03043079|BG003|Baseline|Total|Total of all reporting groups
11301137|NCT03043079|FG000|Participant Flow|Ventral Hernia|"Twenty-One patients diagnosed with ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301138|NCT03043079|FG001|Participant Flow|Healthy Volunteers|"Fourteen volunteers without ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301139|NCT03043079|FG002|Participant Flow|Active Health Volunteers|"Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301140|NCT03043079|OG000|Outcome|Ventral Hernia|"Twenty-one patients diagnosed with ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301141|NCT03043079|OG001|Outcome|Healthy Volunteers|"Fourteen volunteers without ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301142|NCT03043079|OG002|Outcome|Active Health Volunteers|"Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)"
11301143|NCT03043079|OG000|Outcome|Ventral Hernia|"Twenty-one patients diagnosed with ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)~No adverse events Related to study. No incidental findings from the Ultrasound"
11301144|NCT03043079|EG000|Reported Event|Ventral Hernia|"Twenty-one patients diagnosed with ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)~No adverse events Related to study"
11341904|NCT03691948|OG001|Outcome|Control|Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
11301145|NCT03043079|EG001|Reported Event|Healthy Volunteers|"Fourteen volunteers without ventral hernia~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)~No adverse events Related to study"
11301146|NCT03043079|EG002|Reported Event|Active Health Volunteers|"Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity~Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)~No adverse events Related to study"
11301147|NCT03043105|BG000|Baseline|TCP Treatment Group|"The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.~Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;~Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;~Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year."
11301148|NCT03043105|FG000|Participant Flow|TCP Treatment Group|"The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.~Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;~Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;~Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year."
11301149|NCT03043105|OG000|Outcome|TCP Treatment Group|"The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.~Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;~Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;~Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year."
11301150|NCT03043105|EG000|Reported Event|TCP Treatment Group|"The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.~Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;~Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;~Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year."
11301151|NCT03043274|BG000|Baseline|Cangrelor|The final subject count in this arm is 13.
11301152|NCT03043274|BG001|Baseline|No Cangrelor|The final subject number in this arm is 9.
11301153|NCT03043274|BG002|Baseline|Total|Total of all reporting groups
11301154|NCT03043274|FG000|Participant Flow|Cangrelor|Patients received standard of care in addition to cangrelor with a dose of 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion, started prior to PPCI, and continued for 2 hours or for the duration of the procedure, whichever is longer.
11301155|NCT03043274|FG001|Participant Flow|No Cangrelor|This arm received standard of care alone
11301156|NCT03043274|OG000|Outcome|Cangrelor|The final subject count in this arm is 13.
11301157|NCT03043274|OG001|Outcome|No Cangrelor|The final subject number in this arm is 9.
11301158|NCT03043274|EG000|Reported Event|Cangrelor|The final subject count in this arm is 13.
11301159|NCT03043274|EG001|Reported Event|No Cangrelor|The final subject number in this arm is 9.
11301160|NCT03043365|BG000|Baseline|Arm 1: Control Fish Oil First, Then Saury Oil|Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals
11301161|NCT03043365|BG001|Baseline|Arm 2:Saury Oil First, Then Control Fish Oil|Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm LCMUFA-rich saury oil: 4 capsules, 3 times a day after meals
11301162|NCT03043365|BG002|Baseline|Total|Total of all reporting groups
11301163|NCT03043365|FG000|Participant Flow|Arm 1: Control Fish Oil Arm Then Saury Oil|Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and cross-over to the Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals
11301164|NCT03043365|FG001|Participant Flow|Arm 2 - Saury Oil Arm Then Control Fish Oil|Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil: 4 capsules, 3 times a day after meals
11301165|NCT03043365|OG000|Outcome|Arm 1 - Control Fish Oil Arm|Subjects randomized to the control fish oil arm will take 3g of control /day (12 gel capsules/day) for 8 weeks
11301166|NCT03043365|OG001|Outcome|Arm 2 - Saury Oil Arm|Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
11301167|NCT03043365|OG000|Outcome|Arm 1 - Control Fish Oil Arm|Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks
11301168|NCT03043365|EG000|Reported Event|Arm 1: Control Fish Oil Arm|Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks
11301169|NCT03043365|EG001|Reported Event|Arm 2: Saury Oil Arm|Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks
11301170|NCT03043365|EG002|Reported Event|Washout Period|No intervention administer to participants.
11332893|NCT03503162|BG000|Baseline|Colonoscopy With Pure-Vu System|"Inpatient colonoscopies with Pure-Vu System- Single Arm~Pure-Vu System: The Pure-Vu System is FDA cleared device intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood."
11332894|NCT03503162|FG000|Participant Flow|Colonoscopy With Pure-Vu System|"Inpatient colonoscopies with Pure-Vu System- Single Arm~Pure-Vu System: The Pure-Vu System is FDA cleared device intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood."
10971675|NCT00916357|FG000|Participant Flow|Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with up to 0.3- to 0.5-U/kg Humalog + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
10971676|NCT00916357|FG001|Participant Flow|Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
10971677|NCT00916357|FG002|Participant Flow|Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period
10971678|NCT00916357|FG003|Participant Flow|Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog following a 3- to 14-day washout period.
11217483|NCT02314052|BG000|Baseline|DCR-MYC|"Patient groups (cohorts) will receive a single dose level of DCR-MYC; the dose level of DCR-MYC will be increased in subsequent cohorts~DCR-MYC: Dosing: 2 hour IV infusion on Day 1 and 8 of each 21 day cycle.~Starting dose: 0.125mg/kg/dose~Number of cycles: until progression or unacceptable toxicity develops.~PHASE 1b Dose escalation: 50% or 25% increase in subsequent cohorts depending upon toxicity until maximum tolerated dose (MTD) is identified.~PHASE 2 Cohort expansion at the MTD: Additional patients to be treated at the highest dose tolerated to assess efficacy and further assess safety"
11217484|NCT02314052|FG000|Participant Flow|Cohort 1|N = 3, received two, 2-hour infusions of 0.125 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217485|NCT02314052|FG001|Participant Flow|Cohort 2|N = 3, received two, 2-hour infusions of 0.2 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217486|NCT02314052|FG002|Participant Flow|Cohort 3|N = 3, received two, 2-hour infusions of 0.3 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217487|NCT02314052|FG003|Participant Flow|Cohort 4|N = 3, received two, 2-hour infusions of 0.45 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217488|NCT02314052|FG004|Participant Flow|Cohort 5|N = 6, received two, 2-hour infusions of 0.68 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217489|NCT02314052|FG005|Participant Flow|Cohort 6|N = 3, received two, 2-hour infusions of 0.85 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217490|NCT02314052|OG000|Outcome|Cohort 1|N = 3, received two, 2-hour infusions of 0.125 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217491|NCT02314052|OG001|Outcome|Cohort 2|N = 3, received two, 2-hour infusions of 0.2 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217492|NCT02314052|OG002|Outcome|Cohort 3|N = 3, received two, 2-hour infusions of 0.3 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217493|NCT02314052|OG003|Outcome|Cohort 4|N = 3, received two, 2-hour infusions of 0.45 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217494|NCT02314052|OG004|Outcome|Cohort 5|N = 6, received two, 2-hour infusions of 0.68 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11301171|NCT03043534|BG000|Baseline|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
11301172|NCT03043534|BG001|Baseline|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
11301173|NCT03043534|BG002|Baseline|Total|Total of all reporting groups
11301174|NCT03043534|FG000|Participant Flow|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
11301175|NCT03043534|FG001|Participant Flow|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
11301176|NCT03043534|OG000|Outcome|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
11301177|NCT03043534|OG001|Outcome|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
11301178|NCT03043534|EG000|Reported Event|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.~shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE~Brush: All subjects randomized to brush will use the brush with each shave"
11301179|NCT03043534|EG001|Reported Event|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
11301180|NCT03043560|BG000|Baseline|Ezogabine|Ezogabine up to 900mg/day daily for 5 weeks
11301181|NCT03043560|BG001|Baseline|Placebo|Matching placebo pill daily for 5 weeks
11301182|NCT03043560|BG002|Baseline|Total|Total of all reporting groups
11301183|NCT03043560|FG000|Participant Flow|Ezogabine|Ezogabine up to 900mg/day daily for 5 weeks
11301184|NCT03043560|FG001|Participant Flow|Placebo|Matching placebo pill daily for 5 weeks
11301185|NCT03043560|OG000|Outcome|Ezogabine|Ezogabine up to 900mg/day daily for 5 weeks
11301186|NCT03043560|OG001|Outcome|Placebo|Matching placebo pill daily for 5 weeks
11301187|NCT03043560|EG000|Reported Event|Ezogabine|Ezogabine up to 900mg/day daily for 5 weeks
11301188|NCT03043560|EG001|Reported Event|Placebo|Matching placebo pill daily for 5 weeks
11301189|NCT03043651|BG000|Baseline|Oral Treprostinil|"Sustained-release tablets for TID administration~Oral Treprostinil: Sustained-release oral tablets for TID administration"
11301190|NCT03043651|FG000|Participant Flow|Oral Treprostinil|"Sustained-release tablets for TID administration~Oral Treprostinil: Sustained-release oral tablets for TID administration"
11301191|NCT03043651|OG000|Outcome|Oral Treprostinil|"Sustained-release tablets for TID administration~Oral Treprostinil: Sustained-release oral tablets for TID administration"
11301192|NCT03043651|EG000|Reported Event|Oral Treprostinil|"Sustained-release tablets for TID administration~Oral Treprostinil: Sustained-release oral tablets for TID administration"
11301193|NCT03043885|BG000|Baseline|Platelet-rich Fibrin|PRF: Autologous blood product used to graft extraction socket
11301194|NCT03043885|BG001|Baseline|PRF+FDBA|"FDBA: Graft material used to graft extraction socket~PRF: Autologous blood product used to graft extraction socket"
11301195|NCT03043885|BG002|Baseline|FDBA|FDBA: Graft material used to graft extraction socket
11301196|NCT03043885|BG003|Baseline|Blood Clot|Blood Clot: Surgical treatment of extraction socket without addition of graft material
11301197|NCT03043885|BG004|Baseline|Total|Total of all reporting groups
11301198|NCT03043885|FG000|Participant Flow|Platelet-rich Fibrin|PRF: Autologous blood product used to graft extraction socket
11301199|NCT03043885|FG001|Participant Flow|PRF+FDBA|"FDBA: Graft material used to graft extraction socket~PRF: Autologous blood product used to graft extraction socket"
11301200|NCT03043885|FG002|Participant Flow|FDBA|FDBA: Graft material used to graft extraction socket
11301201|NCT03043885|FG003|Participant Flow|Blood Clot|Blood Clot: Surgical treatment of extraction socket without addition of graft material
11301202|NCT03043885|OG000|Outcome|Platelet-rich Fibrin|PRF: Autologous blood product used to graft extraction socket
11301203|NCT03043885|OG001|Outcome|PRF+FDBA|"FDBA: Graft material used to graft extraction socket~PRF: Autologous blood product used to graft extraction socket"
11301204|NCT03043885|OG002|Outcome|FDBA|FDBA: Graft material used to graft extraction socket
11301205|NCT03043885|OG003|Outcome|Blood Clot|Blood Clot: Surgical treatment of extraction socket without addition of graft material
11301206|NCT03043885|EG000|Reported Event|Platelet-rich Fibrin|PRF: Autologous blood product used to graft extraction socket
11301207|NCT03043885|EG001|Reported Event|PRF+FDBA|"FDBA: Graft material used to graft extraction socket~PRF: Autologous blood product used to graft extraction socket"
11301208|NCT03043885|EG002|Reported Event|FDBA|FDBA: Graft material used to graft extraction socket
11301209|NCT03043885|EG003|Reported Event|Blood Clot|Blood Clot: Surgical treatment of extraction socket without addition of graft material
11301210|NCT03044028|BG000|Baseline|NMES Preoperative and Postoperative|"Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study~CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA)."
11301211|NCT03044028|BG001|Baseline|NMES Postoperative Only|"Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study~CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA)."
11301212|NCT03044028|BG002|Baseline|No Intervention|Subject will not be given device and will undergo the standard rehab protocol alone
11301213|NCT03044028|BG003|Baseline|Total|Total of all reporting groups
11301214|NCT03044028|FG000|Participant Flow|NMES Preoperative and Postoperative|"Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study~CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA)."
11301215|NCT03044028|FG001|Participant Flow|NMES Postoperative Only|"Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study~CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA)."
11301216|NCT03044028|FG002|Participant Flow|No Intervention|Subject will not be given device and will undergo the standard rehab protocol alone
11301217|NCT03044028|OG000|Outcome|NMES Preoperative and Postoperative|NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
11301218|NCT03044028|OG001|Outcome|NMES Postoperative Only|NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
11301219|NCT03044028|OG002|Outcome|Control - no NMES|Control - no NMES, patients did not use the device
11301220|NCT03044028|OG001|Outcome|NMES Postoperative Only|NMES Postoperative only, patients used the device a minimum 200 min/wk postoperatively
11301221|NCT03044028|EG000|Reported Event|NMES Preoperative and Postoperative|NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
11301222|NCT03044028|EG001|Reported Event|NMES Postoperative Only|NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
11301223|NCT03044028|EG002|Reported Event|Control - no NMES|Control - no NMES, patients did not use the device
11301224|NCT03044106|BG000|Baseline|All Participants|This is the total of all participants that began the trial and completed at least one visit.
10848385|NCT00289783|OG001|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11301225|NCT03044106|FG000|Participant Flow|CLRT, Then SHAM|Subject will perform KEA (knee extension angle), HHD (handheld dynamometry), PPT (pain pressure threshold) functional tests. Investigator will record the mean of 3 attempts for each test. Subject will don protective eyewear. CLRT (Cranial Laser Reflex Technique) will be performed: the aperture of the laser probe will be placed at one end of the reflex (a), turned on and moved to the end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times. After CLRT is completed, the KEA, PPT and HHD tests will be repeated and the mean of 3 attempts for each will be recorded.
11301226|NCT03044106|FG001|Participant Flow|SHAM, Then CLRT|The identical procedures will be followed as in the other arm. The only difference is the the laser device will be in sham mode: all lights and sounds are operational with no laser emission from the aperture.
11301227|NCT03044106|OG000|Outcome|CLRT|Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The treatment device to be used in this study is a Class 3B, 810 nanometer (nm), 200 milliwatt (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US.The aperture of the laser probe will be placed at the posterior end of the reflex, turned on and moved to the anterior end of the reflex at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
11301228|NCT03044106|OG001|Outcome|SHAM|The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
11332895|NCT03503162|OG000|Outcome|Colonoscopy With Pure-Vu System|"Inpatient colonoscopy procedure with Pure-Vu System~Pure-Vu System: The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood."
11301229|NCT03044106|OG000|Outcome|CLRT|"Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The aperture of the laser probe will be placed at the posterior end of the reflex (a), turned on and moved to the anterior end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.~The spot size is 0.0364 cm², and the treatment time is 30 seconds. Since the CRP is a line of 2 cm, for the purposes of calculating dosage, we will treat it as a series of 10 connected points each with a diameter of 2mm. With the scanning rate of 2 cm/s, each point on the line will receive 1/10 of each pass, totaling 3s (out of 30s total) exposure time per point. The dose per point for this intervention is calculated to be approximately 1.65 J/cm²."
10971679|NCT00916357|FG004|Participant Flow|Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3-to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
10971680|NCT00916357|FG005|Participant Flow|Humulin-R + rHuPH20, Then Humalog + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog alone following a 3- to 14-day washout period.
10971681|NCT00916357|OG000|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
10971682|NCT00916357|OG001|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
10971683|NCT00916357|OG002|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
10971684|NCT00916357|OG002|Outcome|Humulin-R + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
10971685|NCT00916357|EG000|Reported Event|Humalog Alone|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog during Periods 1, 2, or 3 of the study.
10971686|NCT00916357|EG001|Reported Event|Humalog + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20 during Periods 1, 2, or 3 of the study.
10971687|NCT00916357|EG002|Reported Event|Humulin-R + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20 during Periods 1, 2, or 3 of the Study
10971688|NCT00916370|BG000|Baseline|Core Size Registry|Core size indicates the range of diameters of the stents used.
10971689|NCT00916370|BG001|Baseline|Long Lesion Registry|Use of long lesion stents.
10971690|NCT00916370|BG002|Baseline|Total|Total of all reporting groups
10971691|NCT00916370|FG000|Participant Flow|Core Size Registry|Core size indicates the range of diameters of the stents used.
10971692|NCT00916370|FG001|Participant Flow|Long Lesion Registry|Use of long lesion stents.
10971693|NCT00916370|OG000|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
10971694|NCT00916370|OG001|Outcome|Long Lesion Registry|Use of long lesion stents.
10971695|NCT00916370|OG001|Outcome|Long Lesion Registry|use of long lesion stents.
10971696|NCT00916370|EG000|Reported Event|Core Size Registry|Core size indicates the range of diameters of the stents used.
10971697|NCT00916370|EG001|Reported Event|Long Lesion Registry|Use of long lesion stents.
10971698|NCT00916383|BG000|Baseline|All Participants|All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
10971699|NCT00916383|FG000|Participant Flow|All Participants|"Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.~Upper Back, Upper Arm, Side of Torso~Upper Arm, Side of Torso, Upper Back~Side of Torso, Upper Back, Upper Arm~Upper Back, Side of Torso, Upper Arm~Upper Arm, Upper Back, Side of Torso~Side of Torso, Upper Arm, Upper Back~Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal."
10971700|NCT00916383|OG000|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
11301230|NCT03044106|OG001|Outcome|Sham|The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
11301231|NCT03044106|OG000|Outcome|CLRT|"Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The aperture of the laser probe will be placed at the posterior end of the reflex (a), turned on and moved to the anterior end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.~The spot size is 0.0364 cm², and the treatment time is 30 seconds. Since the CRP is a line of 2 cm, for the purposes of calculating dosage, we will treat it as a series of 10 connected points each with a diameter of 2mm. With the scanning rate of 2cm/s, each point on the line will receive 1/10 of each pass, totaling 3s (out of 30 s total) exposure time per point. The dose per point for this intervention is calculated to be approximately 1.65 J/cm²."
11301232|NCT03044106|OG000|Outcome|Active CLRT, History of Hamstring Strain|Participants receiving active treatment who reported a prior history of hamstring strain (n=8). This group approximates a clinical population.
11301233|NCT03044106|OG001|Outcome|Sham CLRT With History of Hamstring Strain|Participants receiving sham treatment who reported a prior history of hamstring strain (n=8)
11301234|NCT03044106|OG002|Outcome|Active CLRT With no Prior Hamstring Strain|Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
11301235|NCT03044106|OG003|Outcome|Sham CLRT With no History of Hamstring Strain|Participants receiving sham CLRT with no history of hamstring strain
11301236|NCT03044106|EG000|Reported Event|CLRT|Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The aperture of the laser probe will be placed at posterior end of the reflex (a), turned on and moved to the anterior end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
11301237|NCT03044106|EG001|Reported Event|SHAM|The laser is inactive, all other descriptions are the same as active.
11301238|NCT03044197|BG000|Baseline|MRI/Ultrasound Transperineal Prostate Biopsy|"In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.~MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest"
11301239|NCT03044197|BG001|Baseline|Transrectal Ultrasound-guided Prostate Biopsy|"TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.~transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores"
11301240|NCT03044197|BG002|Baseline|Total|Total of all reporting groups
11301241|NCT03044197|FG000|Participant Flow|MRI/Ultrasound Transperineal Prostate Biopsy|"In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.~MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest"
11301242|NCT03044197|FG001|Participant Flow|Transrectal Ultrasound-guided Prostate Biopsy|"TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.~transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores"
11301243|NCT03044197|OG000|Outcome|MRI/Ultrasound Transperineal Prostate Biopsy|"In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.~MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest"
10971701|NCT00916383|OG001|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
11301244|NCT03044197|OG001|Outcome|Transrectal Ultrasound-guided Prostate Biopsy|"TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.~transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores"
11301245|NCT03044197|EG000|Reported Event|MRI/Ultrasound Transperineal Prostate Biopsy|"In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.~MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest"
11301246|NCT03044197|EG001|Reported Event|Transrectal Ultrasound-guided Prostate Biopsy|"TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.~transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores"
11301247|NCT03044249|BG000|Baseline|Placebo|Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.
11301248|NCT03044249|BG001|Baseline|MP-101|"Week 0:~Participants received 20 mg MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.~Week 1:~Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
11301249|NCT03044249|BG002|Baseline|Total|Total of all reporting groups
11301250|NCT03044249|FG000|Participant Flow|Placebo|Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.
11301251|NCT03044249|FG001|Participant Flow|MP-101|"Week 0:~Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.~Week 1:~Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
11301252|NCT03044249|OG000|Outcome|Placebo|Participants received 3 capsules of placebo orally once daily (QD) during Week 0, Week 1 and Week 2 through Week 9.
11301253|NCT03044249|OG001|Outcome|MP-101|"Week 0:~Participants received 20 mg MP-101 orally QD ((1 x 20-mg caps and 2 placebo caps)).~Week 1:~Participants received 40 mg MP-101 orally QD ((2 x 20-mg caps and 1 placebo caps)).~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
11301254|NCT03044249|OG000|Outcome|Placebo|Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.
11301255|NCT03044249|OG001|Outcome|MP-101|"Week 0:~Participants received 20 mg MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.~Week 1:~Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
11301256|NCT03044249|OG001|Outcome|MP-101|"Week 0:~Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.~Week 1:~Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
11301257|NCT03044249|OG000|Outcome|MP-101|Participants received 60 mg MP-101 orally QD (3 x 20-mg caps).
11301258|NCT03044249|OG001|Outcome|LY2812223 (MP-101 Metabolite)|Participants received 60 mg MP-101 orally QD (3 x 20-mg caps).
11301259|NCT03044249|EG000|Reported Event|Placebo|Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.
11301260|NCT03044249|EG001|Reported Event|MP-101|"Week 0:~Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps.~Week 1:~Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps.~Week 2 through Week 9:~Participants received 60 mg MP-101 orally QD (3 x 20-mg caps )."
10822255|NCT00075582|OG000|Outcome|Regimen II (Stage I Group III Nonorbit or Stage III Group I/II|"Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10848386|NCT00289783|OG002|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
10971702|NCT00916383|OG002|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
11301261|NCT03044353|BG000|Baseline|Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants|Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
11301262|NCT03044353|BG001|Baseline|Group 2: Post-chemotherapy AL Amyloidosis Participants|Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301263|NCT03044353|BG002|Baseline|Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants|Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301264|NCT03044353|BG003|Baseline|Total|Total of all reporting groups
11301265|NCT03044353|FG000|Participant Flow|Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants|Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
11301266|NCT03044353|FG001|Participant Flow|Group 2: Post-chemotherapy AL Amyloidosis Participants|Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301267|NCT03044353|FG002|Participant Flow|Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants|Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
10971703|NCT00916383|EG000|Reported Event|Systemic Events|All enrolled patients
10971704|NCT00916383|EG001|Reported Event|DTP-system|Localized events
11301268|NCT03044353|OG000|Outcome|Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants|Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
11301269|NCT03044353|OG001|Outcome|Group 2: Post-chemotherapy AL Amyloidosis Participants|Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301270|NCT03044353|OG000|Outcome|Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants|Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301271|NCT03044353|EG000|Reported Event|Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants|Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
11301272|NCT03044353|EG001|Reported Event|Group 2: Post-chemotherapy AL Amyloidosis Participants|Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
11301273|NCT03044418|BG000|Baseline|The Side Effects of Anesthesia With Special ET Laser Tube|"The frequency of side effects of anesthesia with a special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia.~The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery."
11301274|NCT03044418|FG000|Participant Flow|Anesthesia With Special ET Laser Tube|"The special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia.~The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery."
10822256|NCT00075582|EG000|Reported Event|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10971705|NCT00916383|EG002|Reported Event|Placebo Patch|Localized events
10971706|NCT00916539|BG000|Baseline|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
11301275|NCT03044418|OG000|Outcome|Anesthesia With Laser Tube|the side effects of anesthesia with a special ET laser tube
11301276|NCT03044418|EG000|Reported Event|The Frequency of Side Effects of Special ET Laser Tube Using|"The frequency of side effects of anesthesia with special ET laser tube are analysed during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia.~The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery."
11301277|NCT03044431|BG000|Baseline|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
11301278|NCT03044431|FG000|Participant Flow|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
11301279|NCT03044431|OG000|Outcome|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
11301280|NCT03044431|EG000|Reported Event|Cell Therapy Treated|"All patients/participants enrolled will undergo cell therapy~Cell therapy: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day."
11301281|NCT03044574|BG000|Baseline|Experimental Group (SCD + GCS + LMWH)|"Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with a 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in the surgery department - all time of bed rest. SCD used until discharge.~Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with a pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~Low-Molecular-Weight Heparin: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301282|NCT03044574|BG001|Baseline|Control Group (GCS + LMWH)|"GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301283|NCT03044574|BG002|Baseline|Total|Total of all reporting groups
10822257|NCT00075582|EG001|Reported Event|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
10822258|NCT00075725|BG000|Baseline|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822259|NCT00075725|BG001|Baseline|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11301284|NCT03044574|FG000|Participant Flow|Experimental Group (SCD + GCS + LMWH)|"Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.~Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~Low-Molecular-Weight-Heparin (LMWH): LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301285|NCT03044574|FG001|Participant Flow|Control Group (GCS + LMWH)|"GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11332896|NCT03503162|EG000|Reported Event|Colonoscopy With Pure-Vu System|"Inpatient colonoscopy procedure with Pure-Vu System~Pure-Vu System: The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood."
11301286|NCT03044574|OG000|Outcome|Experimental Group (SCD + GCS + LMWH)|"SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.~GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301287|NCT03044574|OG001|Outcome|Control Group (GCS + LMWH)|"GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301288|NCT03044574|EG000|Reported Event|Experimental Group (SCD + GCS + LMWH)|"SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.~GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301289|NCT03044574|EG001|Reported Event|Control Group (GCS + LMWH)|"GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge~LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge."
11301290|NCT03044691|BG000|Baseline|Control Clinic|The control group will have to complete the Adaptive Reserve and Change Process Capability Questionnaire and Clinician Survey at baseline and 9 months. Clinicians will provide their usual care related to tobacco and nicotine product use screening and cessation recommendations. Medical record of patients will be reviewed at baseline and at 6 months.
11301291|NCT03044691|BG001|Baseline|Intervention Clinic|"Participants will be asked to complete the Youth Tobacco and Nicotine Product Questionnaire and Parent Brief Questionnaire (PBQ) using the ResearchACTS software at the point of care. A follow-up survey Youth Tobacco and Nicotine Product Primary Care survey will be administered to participants at least 30 days after their clinic visit.~ResearchACTS software: screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software."
11301292|NCT03044691|BG002|Baseline|Total|Total of all reporting groups
11301293|NCT03044691|FG000|Participant Flow|Control Clinic|The control group will have to complete the Adaptive Reserve and Change Process Capability Questionnaire and Clinician Survey at baseline and 9 months. Clinicians will provide their usual care related to tobacco and nicotine product use screening and cessation recommendations. Medical record of patients will be reviewed at baseline and at 6 months.
11301294|NCT03044691|FG001|Participant Flow|Intervention Clinic|"Participants will be asked to complete the Youth Tobacco and Nicotine Product Questionnaire and Parent Brief Questionnaire (PBQ) using the ResearchACTS software at the point of care. A follow-up survey Youth Tobacco and Nicotine Product Primary Care survey will be administered to participants at least 30 days after their clinic visit.~ResearchACTS software: screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software."
11301295|NCT03044691|OG000|Outcome|Control Clinic|The control group will have to complete the Adaptive Reserve and Change Process Capability Questionnaire and Clinician Survey at baseline and 9 months. Clinicians will provide their usual care related to tobacco and nicotine product use screening and cessation recommendations. Medical record of patients will be reviewed at baseline and at 6 months.
11301296|NCT03044691|OG001|Outcome|Intervention Clinic|"Participants will be asked to complete the Youth Tobacco and Nicotine Product Questionnaire and Parent Brief Questionnaire (PBQ) using the ResearchACTS software at the point of care. A follow-up survey Youth Tobacco and Nicotine Product Primary Care survey will be administered to participants at least 30 days after their clinic visit.~ResearchACTS software: screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software."
10971707|NCT00916539|BG001|Baseline|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
11301297|NCT03044691|EG000|Reported Event|Control Clinic|The control group will have to complete the Adaptive Reserve and Change Process Capability Questionnaire and Clinician Survey at baseline and 9 months. Clinicians will provide their usual care related to tobacco and nicotine product use screening and cessation recommendations. Medical record of patients will be reviewed at baseline and at 6 months.
10971708|NCT00916539|BG002|Baseline|Total|Total of all reporting groups
10971709|NCT00916539|FG000|Participant Flow|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
10971710|NCT00916539|FG001|Participant Flow|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
10971711|NCT00916539|OG000|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
10971712|NCT00916539|OG001|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
10971713|NCT00916539|EG000|Reported Event|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
10971714|NCT00916539|EG001|Reported Event|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
10971715|NCT00916578|BG000|Baseline|Single Arm Institution, Open Label, Phase II|The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Tradition therapy does will be 50-57 Gy to the initial clinical target volume.
10971716|NCT00916578|FG000|Participant Flow|Single Arm Institution, Open Label, Phase II|The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Traditional therapy dosage will be 50-57 GY to the initial clinical target volume.
10971717|NCT00916578|OG000|Outcome|Single Arm Institution, Open Label, Phase II|Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.
11217495|NCT02314052|OG005|Outcome|Cohort 6|N = 3, received two, 2-hour infusions of 0.85 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined five 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217496|NCT02314052|EG000|Reported Event|Cohort 1|N = 3, received two, 2-hour infusions of 0.125 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217497|NCT02314052|EG001|Reported Event|Cohort 2|N = 3, received two, 2-hour infusions of 0.2 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217498|NCT02314052|EG002|Reported Event|Cohort 3|N = 3, received two, 2-hour infusions of 0.3 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217499|NCT02314052|EG003|Reported Event|Cohort 4|N = 3, received two, 2-hour infusions of 0.45 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217500|NCT02314052|EG004|Reported Event|Cohort 5|N = 6, received two, 2-hour infusions of 0.68 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217501|NCT02314052|EG005|Reported Event|Cohort 6|N = 3, received two, 2-hour infusions of 0.85 mg/kg DCR-MYC, once on Day 1 and once on Day 8 within a 21-day cycle. The protocol outlined 5 21-day cycles, each with dosing on days 1 and 8. The study was terminated prematurely and subjects were not treated after the termination date.
11217502|NCT02314104|BG000|Baseline|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217503|NCT02314104|BG001|Baseline|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217504|NCT02314104|BG002|Baseline|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217505|NCT02314104|BG003|Baseline|Total|Total of all reporting groups
11217506|NCT02314104|FG000|Participant Flow|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217507|NCT02314104|FG001|Participant Flow|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217508|NCT02314104|FG002|Participant Flow|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11301298|NCT03044691|EG001|Reported Event|Intervention Clinic|"Participants will be asked to complete the Youth Tobacco and Nicotine Product Questionnaire and Parent Brief Questionnaire (PBQ) using the ResearchACTS software at the point of care. A follow-up survey Youth Tobacco and Nicotine Product Primary Care survey will be administered to participants at least 30 days after their clinic visit.~ResearchACTS software: screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software."
11301299|NCT03044730|BG000|Baseline|Treatment: Pembrolizumab + Capecitabine|This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
11301300|NCT03044730|FG000|Participant Flow|Treatment: Pembrolizumab + Capecitabine|This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
11301301|NCT03044730|OG000|Outcome|Treatment: Pembrolizumab + Capecitabine|This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 1 year for PFS, with visits and/or phone calls.
11301302|NCT03044730|OG000|Outcome|Treatment: Pembrolizumab + Capecitabine|This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
11301303|NCT03044730|EG000|Reported Event|Treatment: Pembrolizumab + Capecitabine|This is a single-arm, phase II study of patients with triple negative (TN) or hormone receptor-positive endocrine-refractory (HR+) metastatic breast cancer (MBC) who were candidates for capecitabine. Patients were treated with pembrolizumab 200 mg intravenously day 1 and capecitabine 1000 mg/m2 by mouth twice daily on days 1-14 of a 21-day cycle. Patients continued treatment until disease progression or unacceptable toxicity. After discontinuation of study drugs, patients were assessed every 3 months up to 2 years for PFS, with visits and/or phone calls.
11301304|NCT03044886|BG000|Baseline|2000IU/Day|"Subjects took 2000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301305|NCT03044886|BG001|Baseline|1000IU/Day|"Subjects took 1000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301306|NCT03044886|BG002|Baseline|Placebo|"Subjects took placebo~vitamin D: Subjects took vitamin D or placebo"
11301307|NCT03044886|BG003|Baseline|Total|Total of all reporting groups
11301308|NCT03044886|FG000|Participant Flow|2000IU/Day|"Subjects took 2000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301309|NCT03044886|FG001|Participant Flow|1000IU/Day|"Subjects took 1000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301310|NCT03044886|FG002|Participant Flow|Placebo|"Subjects took placebo~vitamin D: Subjects took vitamin D or placebo"
11301311|NCT03044886|OG000|Outcome|2000IU/Day|"Subjects took 2000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301312|NCT03044886|OG001|Outcome|1000IU/Day|"Subjects took 1000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301313|NCT03044886|OG002|Outcome|Placebo|"Subjects took placebo~vitamin D: Subjects took vitamin D or placebo"
11301314|NCT03044886|EG000|Reported Event|2000IU/Day|"Subjects took 2000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301315|NCT03044886|EG001|Reported Event|1000IU/Day|"Subjects took 1000IU vitamin D per day~vitamin D: Subjects took vitamin D or placebo"
11301316|NCT03044886|EG002|Reported Event|Placebo|"Subjects took placebo~vitamin D: Subjects took vitamin D or placebo"
11301317|NCT03045081|BG000|Baseline|Usual Care|Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
11301318|NCT03045081|BG001|Baseline|PainTracker Self-Manager|"Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management~PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager"
11301319|NCT03045081|BG002|Baseline|Total|Total of all reporting groups
11301320|NCT03045081|FG000|Participant Flow|Usual Care|Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
11301321|NCT03045081|FG001|Participant Flow|PainTracker Self-Manager|"Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management~PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager"
11301322|NCT03045081|OG000|Outcome|Usual Care|Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
11301323|NCT03045081|OG001|Outcome|PainTracker Self-Manager|"Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management~PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager"
11301324|NCT03045081|EG000|Reported Event|Usual Care|Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
11217509|NCT02314104|OG000|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217510|NCT02314104|OG001|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217511|NCT02314104|OG002|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217512|NCT02314104|EG000|Reported Event|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217513|NCT02314104|EG001|Reported Event|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217514|NCT02314104|EG002|Reported Event|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11217515|NCT02314117|BG000|Baseline|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
11217516|NCT02314117|BG001|Baseline|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
11217517|NCT02314117|BG002|Baseline|Total|Total of all reporting groups
11217518|NCT02314117|FG000|Participant Flow|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
11217519|NCT02314117|FG001|Participant Flow|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
11217520|NCT02314117|OG000|Outcome|Ramucirumab + Cisplatin + Capecitabine|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
11217521|NCT02314117|OG001|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
11301325|NCT03045081|EG001|Reported Event|PainTracker Self-Manager|"Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management~PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager"
11301326|NCT03045302|BG000|Baseline|BIM23B065 BID Stage 1|"Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.~Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).~Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14."
11301327|NCT03045302|FG000|Participant Flow|BIM23B065 BID Stage 1|"Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.~Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).~Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14."
11301328|NCT03045302|OG000|Outcome|BIM23B065 BID Stage 1|"Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.~Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).~Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14."
11301329|NCT03045302|EG000|Reported Event|BIM23B065 BID Stage 1|"Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.~Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).~Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14."
11301330|NCT03045328|BG000|Baseline|Treatment (Ibrutinib, Venetoclax)|"Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.~Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg)."
11301331|NCT03045328|FG000|Participant Flow|Treatment (Ibrutinib, Venetoclax)|"Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.~Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg)."
11301332|NCT03045328|OG000|Outcome|Treatment (Ibrutinib, Venetoclax)|"Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.~Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg)."
11301333|NCT03045328|EG000|Reported Event|Treatment (Ibrutinib, Venetoclax)|"Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.~Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.~Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg)."
11301334|NCT03045809|BG000|Baseline|Women at Risk of Urogenital Infections.|All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
11332897|NCT03503188|BG000|Baseline|IPF Group|All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
11332898|NCT03503188|BG001|Baseline|Non-IPF Group|All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
11332899|NCT03503188|BG002|Baseline|Total|Total of all reporting groups
11301335|NCT03045809|FG000|Participant Flow|Women at Risk of Urogenital Infections.|All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
11301336|NCT03045809|OG000|Outcome|Women at Risk of Urogenital Infections.|All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
11301337|NCT03045809|OG000|Outcome|WHO Syndromic Management (Entire Study Population)|"Syndromic management vs gold standard.~With performance we mean sensitivity, specificity, positive predictive value, and negative predictive value. We determined the number of women who would have received treatment for BV, VVC, TV, NG, and/or CT if we would have followed the WHO syndromic management algorithms for vaginal discharge and lower abdominal pain; and compared this with gold standard infection-specific diagnoses."
11301338|NCT03045809|OG001|Outcome|WISH (Entire Study Population)|"WISH POCT vs gold standard~With performance we mean sensitivity, specificity, positive predictive value, and negative predictive value. We determined the number of women who had received treatment for BV, VVC, TV, NG, and/or CT based on the POCT-based WISH algorithms (this is what we did in real life during the study), and compared this with gold standard infection-specific diagnoses."
11301339|NCT03045809|EG000|Reported Event|Women at Risk of Urogenital Infections.|All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
11301340|NCT03045861|BG000|Baseline|GSK2838232 20 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
11301341|NCT03045861|BG001|Baseline|GSK2838232 50 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301342|NCT03045861|BG002|Baseline|GSK2838232 100 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301343|NCT03045861|BG003|Baseline|GSK2838232 200 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301344|NCT03045861|BG004|Baseline|Total|Total of all reporting groups
11301345|NCT03045861|FG000|Participant Flow|GSK2838232 20 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
11301346|NCT03045861|FG001|Participant Flow|GSK2838232 50 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301347|NCT03045861|FG002|Participant Flow|GSK2838232 100 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301348|NCT03045861|FG003|Participant Flow|GSK2838232 200 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301349|NCT03045861|OG000|Outcome|GSK2838232 20 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
10822260|NCT00075725|BG002|Baseline|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11301350|NCT03045861|OG001|Outcome|GSK2838232 50 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301351|NCT03045861|OG002|Outcome|GSK2838232 100 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301352|NCT03045861|OG003|Outcome|GSK2838232 200 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301353|NCT03045861|OG000|Outcome|Participants Receiving GSK2838232|Participants who received GSK2838232 at doses of 20 mg, 50 mg, 100 mg and 200 mg were included.
11301354|NCT03045861|EG000|Reported Event|GSK2838232 20 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
11301355|NCT03045861|EG001|Reported Event|GSK2838232 50 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301356|NCT03045861|EG002|Reported Event|GSK2838232 100 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301357|NCT03045861|EG003|Reported Event|GSK2838232 200 mg|Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
11301358|NCT03045887|BG000|Baseline|Part A:Placebo/200 µg GSK2292767/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 1 were administered a single dose of placebo in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA Dry Powder Inhaler (DPI). There was a period of 4 weeks between doses for an individual participant.
11301359|NCT03045887|BG001|Baseline|Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 2 were administered a single dose of 50 µg GSK2292767 in Period 1, placebo in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301360|NCT03045887|BG002|Baseline|Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 3 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301361|NCT03045887|BG003|Baseline|Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 4 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301362|NCT03045887|BG004|Baseline|Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 5 were administered a single dose of placebo in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301363|NCT03045887|BG005|Baseline|Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 6 were administered a single dose of 100 ug GSK2292767 in Period 1, placebo in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301364|NCT03045887|BG006|Baseline|Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 7 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301365|NCT03045887|BG007|Baseline|Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 8 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI . There was a period of 4 weeks between doses for an individual participant.
11301366|NCT03045887|BG008|Baseline|Part B: Placebo|Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
11301367|NCT03045887|BG009|Baseline|Part B: GSK2292767 2000 µg OD|Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
11301368|NCT03045887|BG010|Baseline|Total|Total of all reporting groups
11301369|NCT03045887|FG000|Participant Flow|Part A: Placebo/200 µg GSK2292767/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 1 were administered a single dose of placebo in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA Dry Powder Inhaler (DPI). There was a period of 4 weeks between doses for an individual participant.
11301370|NCT03045887|FG001|Participant Flow|Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 2 were administered a single dose of 50 µg GSK2292767 in Period 1, placebo in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301371|NCT03045887|FG002|Participant Flow|Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 3 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301372|NCT03045887|FG003|Participant Flow|Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 4 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301373|NCT03045887|FG004|Participant Flow|Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 5 were administered a single dose of placebo in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301374|NCT03045887|FG005|Participant Flow|Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 6 were administered a single dose of 100 ug GSK2292767 in Period 1, placebo in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301375|NCT03045887|FG006|Participant Flow|Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 7 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
11301376|NCT03045887|FG007|Participant Flow|Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767|Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 8 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI . There was a period of 4 weeks between doses for an individual participant.
11301377|NCT03045887|FG008|Participant Flow|Part B:Placebo|Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
11301378|NCT03045887|FG009|Participant Flow|Part B:GSK2292767 2000 µg OD|Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
11301379|NCT03045887|OG000|Outcome|Placebo|Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
11301380|NCT03045887|OG001|Outcome|50 µg OD|Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301381|NCT03045887|OG002|Outcome|100 µg OD|Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301382|NCT03045887|OG003|Outcome|200 µg OD|Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301383|NCT03045887|OG004|Outcome|500 µg OD|Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301384|NCT03045887|OG005|Outcome|1000 µg OD|Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301385|NCT03045887|OG006|Outcome|2000 µg OD|Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301386|NCT03045887|OG000|Outcome|Placebo|Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
11301387|NCT03045887|OG001|Outcome|2000 µg OD|Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
11301388|NCT03045887|OG000|Outcome|50 µg OD|Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301389|NCT03045887|OG001|Outcome|100 µg OD|Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301390|NCT03045887|OG002|Outcome|200 µg OD|Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301391|NCT03045887|OG003|Outcome|500 µg OD|Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301392|NCT03045887|OG004|Outcome|1000 µg OD|Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301393|NCT03045887|OG005|Outcome|2000 µg OD|Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301394|NCT03045887|OG000|Outcome|2000 µg OD|Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
11301395|NCT03045887|EG000|Reported Event|Part A: Placebo|Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
11301396|NCT03045887|EG001|Reported Event|Part A: 50 µg OD|Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301397|NCT03045887|EG002|Reported Event|Part A: 100 µg OD|Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301398|NCT03045887|EG003|Reported Event|Part A: 200 µg OD|Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301399|NCT03045887|EG004|Reported Event|Part A: 500 µg OD|Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301400|NCT03045887|EG005|Reported Event|Part A: 1000 µg OD|Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301401|NCT03045887|EG006|Reported Event|Part A: 2000 µg OD|Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
11301402|NCT03045887|EG007|Reported Event|Part B: Placebo|Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
11301403|NCT03045887|EG008|Reported Event|Part B: 2000ug OD|Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
11301404|NCT03045926|BG000|Baseline|Smecta® Powder|"Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.~Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125."
11301405|NCT03045926|FG000|Participant Flow|Smecta® Powder|"Subjects received Smecta® (3 grams [g] of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.~Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125."
11301406|NCT03045926|OG000|Outcome|Smecta® Powder|"Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.~Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125."
11301407|NCT03045926|EG000|Reported Event|Smecta® Powder|"Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.~Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125."
11301408|NCT03046056|BG000|Baseline|Filgotinib 200 mg|Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.
11301409|NCT03046056|BG001|Baseline|Filgotinib 100 mg|Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.
11301410|NCT03046056|BG002|Baseline|Placebo|PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
11301411|NCT03046056|BG003|Baseline|Total|Total of all reporting groups
11301412|NCT03046056|FG000|Participant Flow|Filgotinib 200 mg|Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.
11301413|NCT03046056|FG001|Participant Flow|Filgotinib 100 mg|Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.
11301414|NCT03046056|FG002|Participant Flow|Placebo|PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
11301415|NCT03046056|OG000|Outcome|Filgotinib 200 mg|Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.
11301416|NCT03046056|OG001|Outcome|Filgotinib 100 mg|Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.
11301417|NCT03046056|OG002|Outcome|Placebo|PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
11301418|NCT03046056|EG000|Reported Event|Filgotinib 200 mg|Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.
11301419|NCT03046056|EG001|Reported Event|Filgotinib 100 mg|Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.
11301420|NCT03046056|EG002|Reported Event|Placebo|PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
11301421|NCT03046212|BG000|Baseline|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
11301422|NCT03046212|BG001|Baseline|Physical Therapy|This group received only conventional physical therapy (exercises).
11301423|NCT03046212|BG002|Baseline|Total|Total of all reporting groups
11301424|NCT03046212|FG000|Participant Flow|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
11301425|NCT03046212|FG001|Participant Flow|Physical Therapy|This group received only conventional physical therapy (exercises).
11301426|NCT03046212|OG000|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
11301427|NCT03046212|OG001|Outcome|Physical Therapy|This group received only conventional physical therapy (exercises).
11301428|NCT03046212|EG000|Reported Event|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
11301429|NCT03046212|EG001|Reported Event|Physical Therapy|This group received only conventional physical therapy (exercises).
11301430|NCT03046225|BG000|Baseline|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
11301431|NCT03046225|BG001|Baseline|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
11301432|NCT03046225|BG002|Baseline|Total|Total of all reporting groups
11301433|NCT03046225|FG000|Participant Flow|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
11301434|NCT03046225|FG001|Participant Flow|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
11301435|NCT03046225|OG000|Outcome|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
11301436|NCT03046225|OG001|Outcome|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
11301437|NCT03046225|EG000|Reported Event|Electrical Stimulation|This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
11301438|NCT03046225|EG001|Reported Event|Physical Therapy|This group received only conventional physical therapy (continuous passive movement device and exercises).
11301439|NCT03046446|BG000|Baseline|FX006 32 mg|"Single intra-articular injection~FX006 32 mg: Single intra-articular injection"
11301440|NCT03046446|FG000|Participant Flow|FX006 32 mg|"Single intra-articular injection~FX006 32 mg: Single intra-articular injection"
11301441|NCT03046446|OG000|Outcome|FX006 32 mg|"Single intra-articular injection~FX006 32 mg: Single intra-articular injection"
11301442|NCT03046446|EG000|Reported Event|FX006 32 mg|"Single intra-articular injection~FX006 32 mg: Single intra-articular injection"
11301443|NCT03046472|BG000|Baseline|Once a Month and Once a Week.|"Personally meeting once a month of Physical Therapy treatment for Postural Behavior.~In addition exercise group meeting once a week. The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. The Participants in this group will get also a group exercise meeting once a week That meeting will long 45 minutes and will include the exercise that were given as home work and more.~Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301444|NCT03046472|BG001|Baseline|Once a Month Only.|"Personally meeting once a month only for Physical Therapy treatment for Postural Behavior.~The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301445|NCT03046472|BG002|Baseline|Total|Total of all reporting groups
11301446|NCT03046472|FG000|Participant Flow|Once a Month Only.|"Personally meeting once a month only for Physical Therapy treatment for Postural Behavior.~The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301447|NCT03046472|FG001|Participant Flow|Once a Month and Once a Week.|"Personally meeting once a month of Physical Therapy treatment for Postural Behavior.~In addition exercise group meeting once a week. The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. The Participants in this group will get also a group exercise meeting once a week That meeting will long 45 minutes and will include the exercise that were given as home work and more.~Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301448|NCT03046472|OG000|Outcome|Once a Month Only.|"Personally meeting once a month only for Physical Therapy treatment for Postural Behavior.~The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301449|NCT03046472|OG001|Outcome|Once a Month and Once a Week.|"Personally meeting once a month of Physical Therapy treatment for Postural Behavior.~In addition exercise group meeting once a week. The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. The Participants in this group will get also a group exercise meeting once a week That meeting will long 45 minutes and will include the exercise that were given as home work and more.~Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301450|NCT03046472|EG000|Reported Event|Once a Month Only.|"Personally meeting once a month only for Physical Therapy treatment for Postural Behavior.~The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301451|NCT03046472|EG001|Reported Event|Once a Month and Once a Week.|"Personally meeting once a month of Physical Therapy treatment for Postural Behavior.~In addition exercise group meeting once a week. The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day. The Participants in this group will get also a group exercise meeting once a week That meeting will long 45 minutes and will include the exercise that were given as home work and more.~Total duration 12 weeks/3 months~Physical Therapy treatment for Postural Behavior: Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.~All participants will get 10-15 minutes of exercise for performing every day."
11301452|NCT03046966|BG000|Baseline|Control Group|Control: No Training Residents received standard training consisting of intern orientation.
11301453|NCT03046966|BG001|Baseline|Intervention Group|Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
11301454|NCT03046966|BG002|Baseline|Total|Total of all reporting groups
11301455|NCT03046966|FG000|Participant Flow|Intervention Control: No Training|"Does not receive hands-on intubation training in the Simulation Lab.~Intervention: Control No Training: • Does not receive simulation training with PI. Only standard training."
11301456|NCT03046966|FG001|Participant Flow|Intervention: Receives Training|"Receives hands-on intubation training in the Simulation Lab.~Intervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:~Using state of the art technology, a Storz C-MAC video laryngoscope~Identifying anatomical landmarks~Practice on the manikin until intubation occurs within 15 seconds"
11301457|NCT03046966|OG000|Outcome|Control Group|Control: No Training Residents received standard training consisting of intern orientation.
11301458|NCT03046966|OG001|Outcome|Intervention Group|Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
11301459|NCT03046966|EG000|Reported Event|Intervention Control: No Training|"Does not receive hands-on intubation training in the Simulation Lab.~Intervention: Control No Training: • Does not receive simulation training with PI. Only standard training."
11301460|NCT03046966|EG001|Reported Event|Intervention: Receives Training|"Receives hands-on intubation training in the Simulation Lab.~Intervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:~Using state of the art technology, a Storz C-MAC video laryngoscope~Identifying anatomical landmarks~Practice on the manikin until intubation occurs within 15 seconds"
11301461|NCT03047174|BG000|Baseline|Arm A: Treatment With Mepitel® Film|"Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.~Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing."
11301462|NCT03047174|BG001|Baseline|Arm B: Treatment With Standard Care|Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
11301463|NCT03047174|BG002|Baseline|Total|Total of all reporting groups
11301464|NCT03047174|FG000|Participant Flow|Arm A: Treatment With Mepitel® Film|"Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.~Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing."
11301465|NCT03047174|FG001|Participant Flow|Arm B: Treatment With Standard Care|Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
11301466|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
11301467|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
11301468|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and were treated per protocol.
11301469|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and were treated per protocol.
11301470|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301471|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301472|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and belonged to the intention-to-treat population.
11301473|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and belonged to the intention-to-treat population.
11301474|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for radiation dermatitis up to 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301475|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for radiation dermatitis up to 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301476|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for pain at baseline and at 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301477|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for pain at baseline and at 50 Gy of radiotherapy and belonged to the intention-to-treat population.
11301478|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for pain at baseline and at 60 Gy of radiotherapy and belonged to the intention-to-treat population.
11301479|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for pain at baseline and at 60 Gy of radiotherapy and belonged to the intention-to-treat population.
11301480|NCT03047174|OG000|Outcome|Arm A: Treatment With Mepitel® Film|Patients treated with Mepitel® Film who were evaluable for quality of life at baseline and at 50 Gy of radiotherapy.
11301481|NCT03047174|OG001|Outcome|Arm B: Treatment With Standard Care|Patients treated with Standard Skin Care who were evaluable for quality of life at baseline and at 50 Gy of radiotherapy.
11301482|NCT03047174|EG000|Reported Event|Arm A: Treatment With Mepitel® Film|"Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.~Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing."
11301483|NCT03047174|EG001|Reported Event|Arm B: Treatment With Standard Care|Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
11301484|NCT03047447|BG000|Baseline|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301485|NCT03047447|BG001|Baseline|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301486|NCT03047447|BG002|Baseline|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301487|NCT03047447|BG003|Baseline|Total|Total of all reporting groups
11301488|NCT03047447|FG000|Participant Flow|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301489|NCT03047447|FG001|Participant Flow|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301490|NCT03047447|FG002|Participant Flow|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301491|NCT03047447|OG000|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.00"
11301492|NCT03047447|OG001|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.11"
11301493|NCT03047447|OG002|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes.~p=.211"
11301494|NCT03047447|OG000|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301495|NCT03047447|OG001|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301496|NCT03047447|OG002|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301497|NCT03047447|EG000|Reported Event|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301498|NCT03047447|EG001|Reported Event|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301499|NCT03047447|EG002|Reported Event|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes"
11301500|NCT03047551|BG000|Baseline|Transabdominal Sonography|"Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.~A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.~Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301501|NCT03047551|BG001|Baseline|Transvaginal Sonography|"Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.~Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.~Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301502|NCT03047551|BG002|Baseline|Total|Total of all reporting groups
11301503|NCT03047551|FG000|Participant Flow|Transabdominal Sonography|"Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.~A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.~Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301504|NCT03047551|FG001|Participant Flow|Transvaginal Sonography|"Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.~Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.~Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11332900|NCT03503188|FG000|Participant Flow|IPF Group|All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
11301505|NCT03047551|OG000|Outcome|Transabdominal Sonography|"Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.~A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.~Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301506|NCT03047551|OG001|Outcome|Transvaginal Sonography|"Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.~Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.~Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301507|NCT03047551|EG000|Reported Event|Transabdominal Sonography|"Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.~A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.~Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301508|NCT03047551|EG001|Reported Event|Transvaginal Sonography|"Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.~Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.~Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare."
11301509|NCT03047720|BG000|Baseline|Lully Device First, Then No Device|"Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2)~No washout period between S1 and S2 because there was no carryover effect from either intervention"
11301510|NCT03047720|BG001|Baseline|No Device First, Then Lully Device|"Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1)~No washout period between S2 and S1 because there was no carryover effect from either intervention"
11301511|NCT03047720|BG002|Baseline|Total|Total of all reporting groups
11301512|NCT03047720|FG000|Participant Flow|Lully Device First, Then No Device|"Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2)~No washout period between S1 and S2 because there was no carryover effect from either intervention"
11301513|NCT03047720|FG001|Participant Flow|No Device First, Then Lully Device|"Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1)~No washout period between S2 and S1 because there was no carryover effect from either intervention"
11301514|NCT03047720|OG000|Outcome|Lully Device|Participants who completed 6 weeks of behavioral modifications plus the Lully device
11217522|NCT02314117|OG001|Outcome|Placebo + Cisplatin + Capecitabine|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle.
11217523|NCT02314117|EG000|Reported Event|LY3009806+Capecitabine+Cisplatin|8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
11217524|NCT02314117|EG001|Reported Event|Placebo+Capecitabine+Cisplatin|Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
11217525|NCT02314143|BG000|Baseline|Dabrafenib Followed by Combination Therapy|Eligible participants received dabrafenib 150 milligrams (mg) twice a day (BID) continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217526|NCT02314143|BG001|Baseline|Trametinib Followed by Combination Therapy|Eligible participants received trametinib 2 mg per day continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217527|NCT02314143|BG002|Baseline|Combination Therapy|Eligible participants received trametinib 2 mg per day plus dabrafenib 150 mg BID continuously until disease progression, death or unacceptable toxicity.
11217528|NCT02314143|BG003|Baseline|Total|Total of all reporting groups
11217529|NCT02314143|FG000|Participant Flow|Dabrafenib Followed by Combination Therapy|Eligible participants received dabrafenib 150 milligrams (mg) twice a day (BID) continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217530|NCT02314143|FG001|Participant Flow|Trametinib Followed by Combination Therapy|Eligible participants received trametinib 2 mg per day continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217531|NCT02314143|FG002|Participant Flow|Combination Therapy|Eligible participants received trametinib 2 mg per day plus dabrafenib 150 mg BID continuously until disease progression, death or unacceptable toxicity.
11217532|NCT02314143|OG000|Outcome|Combination Therapy|Eligible participants received trametinib 2 mg per day plus dabrafenib 150 mg BID continuously until disease progression, death or unacceptable toxicity.
11217533|NCT02314143|OG000|Outcome|Dabrafenib Followed by Combination Therapy|Eligible participants received dabrafenib 150 milligrams (mg) twice a day (BID) continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217534|NCT02314143|OG001|Outcome|Trametinib Followed by Combination Therapy|Eligible participants received trametinib 2 mg per day continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217535|NCT02314143|OG002|Outcome|Combination Therapy|Eligible participants received trametinib 2 mg per day plus dabrafenib 150 mg BID continuously until disease progression, death or unacceptable toxicity.
11217536|NCT02314143|EG000|Reported Event|Dabrafenib Followed by Combination Therapy|Eligible participants received dabrafenib 150 milligrams (mg) twice a day (BID) continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217537|NCT02314143|EG001|Reported Event|Trametinib Followed by Combination Therapy|Eligible participants received trametinib 2 mg per day continuously during 8 weeks of monotherapy treatment followed by the combination of trametinib 2 mg once daily with dabrafenib 150 mg BID until disease progression, death or unacceptable toxicity.
11217538|NCT02314143|EG002|Reported Event|Combination Therapy|Eligible participants received trametinib 2 mg per day plus dabrafenib 150 mg BID continuously until disease progression, death or unacceptable toxicity.
11217539|NCT02314247|BG000|Baseline|Selinexor (PTCL)|Assigned to 60 mg dose, 6 doses/cycle
11217540|NCT02314247|BG001|Baseline|Selinexor (CTCL)|Assigned to 60 mg dose, 6 doses/cycle (6 patients); Assigned to 60 mg dose, 8 doses/cycle (1 patient)
11217541|NCT02314247|BG002|Baseline|Total|Total of all reporting groups
11217542|NCT02314247|FG000|Participant Flow|Selinexor (PTCL)|Assigned to 60 mg dose twice weekly
11217543|NCT02314247|FG001|Participant Flow|Selinexor (CTCL)|Assigned to 60 mg dose twice weekly
11217544|NCT02314247|FG002|Participant Flow|Selinexor (CTCL) 8 Doses/Cycle|Assigned to 60 mg dose twice weekly for weeks 1-4
11217545|NCT02314247|OG000|Outcome|Selinexor (PTCL)|Assigned to 60 mg dose, 6 doses/cycle
11217546|NCT02314247|OG001|Outcome|Selinexor (CTCL)|Assigned to 60 mg dose, 6 doses/cycle (6 patients); Assigned to 60 mg dose, 8 doses/cycle (1 patient)
11217547|NCT02314247|OG000|Outcome|Selinexor (PTCL)|Assigned to 60 mg dose; 6 doses/cycle
11217548|NCT02314247|OG000|Outcome|Selinexor (PTCL)|Assigned to 60 mg, 6 doses/cycle
11217549|NCT02314247|OG001|Outcome|Selinexor (CTCL)|Assigned to 60 mg, 6 doses/cycle
11217550|NCT02314247|OG001|Outcome|Selinexor (CTCL)|Assigned to 60 mg dose, 6 doses/cycle (6 patients); assigned to 60 mg dose, 8 doses/cycle (1 patient)
11217551|NCT02314247|EG000|Reported Event|Selinexor (PTCL)|Assigned to 60 mg; 6 doses/cycle
11301515|NCT03047720|OG001|Outcome|No Device|Participants who completed 6 weeks of behavioral modifications only without the device
11301516|NCT03047720|EG000|Reported Event|S1: Lully Device Plus Behavioral Modifications|"The S1 therapeutic phase of this study was: 6 weeks of behavioral modifications plus the Lully device~The family received counseling on behavioral modifications during initial baseline phase to follow throughout S1.~During this phase, a scheduled awakening was performed each night with the Lully pod following the scheduled awakening protocol using Lully Sleep Guardian. This was used to reliably produce a brief awakening by titrating the device to a minimal awakening stimulus during the first night of use. If the brief awakening could not be produced using the Lully pod, the parent was to gently awaken the child~Participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness.~In addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals"
11301517|NCT03047720|EG001|Reported Event|S2: Behavioral Modifications Only|"The S2 therapeutic phase of this study : 6 weeks of behavioral modifications only without the device.~The family received counseling on behavioral modifications during initial baseline phase to follow throughout S1.~During this phase, participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness.~In addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals"
11301518|NCT03047980|BG000|Baseline|Sirolimus|"All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.~Sirolimus: Low dose oral sirolimus"
11301519|NCT03047980|FG000|Participant Flow|Sirolimus|"All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.~Sirolimus: Low dose oral sirolimus"
11301520|NCT03047980|OG000|Outcome|Sirolimus|"All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.~Sirolimus: Low dose oral sirolimus"
11301521|NCT03047980|EG000|Reported Event|Sirolimus|"All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.~Sirolimus: Low dose oral sirolimus"
11301522|NCT03048006|BG000|Baseline|All Included Patients|All included patients underwent MRI with Dotarem
11301523|NCT03048006|FG000|Participant Flow|All Included Patients|All included patients underwent MRI with Dotarem
11301524|NCT03048006|OG000|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
11301525|NCT03048006|EG000|Reported Event|All Included Patients|All included patients underwent MRI with Dotarem
11301526|NCT03048058|BG000|Baseline|Brimonidine Topical Gel 0.33% & Survey|"The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.~brimonidine topical gel 0.33% & survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,"
11301527|NCT03048058|BG001|Baseline|Brimonidine Topical Gel 0.33% & SOC|"Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits~brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%"
11301528|NCT03048058|BG002|Baseline|Total|Total of all reporting groups
11301529|NCT03048058|FG000|Participant Flow|Brimonidine Topical Gel 0.33% & Survey|"The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.~brimonidine topical gel 0.33% & survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,"
11301530|NCT03048058|FG001|Participant Flow|Brimonidine Topical Gel 0.33% & SOC|"Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits~brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%"
11301531|NCT03048058|OG000|Outcome|Brimonidine Topical Gel 0.33% & Survey|Topical drug and standard of care follow-up,with weekly survey.
11301532|NCT03048058|OG001|Outcome|Brimonidine Topical Gel 0.33% & SOC|"Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits~brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%"
11301533|NCT03048058|EG000|Reported Event|Brimonidine Topical Gel 0.33% & Survey|brimonidine topical gel 0.33% & survey adverse events
11301534|NCT03048058|EG001|Reported Event|Brimonidine Topical Gel 0.33% & SOC|Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
11301535|NCT03048383|BG000|Baseline|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301536|NCT03048383|BG001|Baseline|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301537|NCT03048383|BG002|Baseline|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
11301538|NCT03048383|BG003|Baseline|Total|Total of all reporting groups
11301539|NCT03048383|FG000|Participant Flow|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301540|NCT03048383|FG001|Participant Flow|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301541|NCT03048383|FG002|Participant Flow|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
11301542|NCT03048383|OG000|Outcome|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301543|NCT03048383|OG001|Outcome|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301544|NCT03048383|OG002|Outcome|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
11301545|NCT03048383|EG000|Reported Event|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301546|NCT03048383|EG001|Reported Event|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
11301547|NCT03048383|EG002|Reported Event|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.~Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
11301548|NCT03048500|BG000|Baseline|Treatment (Metformin Hydrochloride, Nivolumab)|"Induction: Patients receive treatment with metformin monotherapy PO QD on Day -7 to -1.~Main treatment starting Day 1 of Cycle 1: Patients receive metformin PO QD (Days 1-28 of a 28 days cycle) and nivolumab IV every 14 days (on Days 1 and 15 of a 28 day cycle) for the first 4 cycles and then every 28 days, starting Cycle 5 (Day 1 of a 28 day cycle).~28 day cycles continue in the absence of disease progression, unacceptable toxicity, or withdrawal of consent.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO~Nivolumab: Given IV"
11301549|NCT03048500|FG000|Participant Flow|Treatment (Metformin Hydrochloride, Nivolumab)|"Induction: Patients receive treatment with metformin monotherapy PO QD on Day -7 to -1.~Main treatment starting Day 1 of Cycle 1: Patients receive metformin PO QD (Days 1-28 of a 28 days cycle) and nivolumab IV every 14 days (on Days 1 and 15 of a 28 day cycle) for the first 4 cycles and then every 28 days, starting Cycle 5 (Day 1 of a 28 day cycle).~28 day cycles continue in the absence of disease progression, unacceptable toxicity, or withdrawal of consent.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO~Nivolumab: Given IV"
11301550|NCT03048500|OG000|Outcome|Treatment (Metformin Hydrochloride, Nivolumab)|"Induction: Patients receive treatment with metformin monotherapy PO QD on Day -7 to -1.~Main treatment starting Day 1 of Cycle 1: Patients receive metformin PO QD (Days 1-28 of a 28 days cycle) and nivolumab IV every 14 days (on Days 1 and 15 of a 28 day cycle) for the first 4 cycles and then every 28 days, starting Cycle 5 (Day 1 of a 28 day cycle).~28 day cycles continue in the absence of disease progression, unacceptable toxicity, or withdrawal of consent.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO~Nivolumab: Given IV"
11301551|NCT03048500|EG000|Reported Event|Treatment (Metformin Hydrochloride, Nivolumab)|"Induction: Patients receive treatment with metformin monotherapy PO QD on Day -7 to -1.~Main treatment starting Day 1 of Cycle 1: Patients receive metformin PO QD (Days 1-28 of a 28 days cycle) and nivolumab IV every 14 days (on Days 1 and 15 of a 28 day cycle) for the first 4 cycles and then every 28 days, starting Cycle 5 (Day 1 of a 28 day cycle).~28 day cycles continue in the absence of disease progression, unacceptable toxicity, or withdrawal of consent.~Laboratory Biomarker Analysis: Correlative studies~Metformin Hydrochloride: Given PO~Nivolumab: Given IV"
11301552|NCT03048747|BG000|Baseline|Tolvaptan|"Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.~Tolvaptan Oral Tablet: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days."
11301553|NCT03048747|FG000|Participant Flow|Tolvaptan|"Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.~Tolvaptan Oral Tablet: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days."
11301554|NCT03048747|OG000|Outcome|Tolvaptan|"Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.~Tolvaptan Oral Tablet: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days."
11301555|NCT03048747|OG000|Outcome|Tolvaptan|Tolvaptan
11301556|NCT03048747|EG000|Reported Event|Tolvaptan|Tolvaptan
11301557|NCT03049215|BG000|Baseline|Lumen Apposing Metal Stent (LAMS)|"Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter.~Lumen Apposing Metal Stent (LAMS): The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst."
11301558|NCT03049215|BG001|Baseline|LAMS Plus Double Pigtail Stent|"Subjects randomized to LAMS plus double pigtail stent will undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter. Following this, wire access across the stent lumen will be achieved using a 0.035 inch hydrophilic guidewire, and a double pigtail plastic biliary stent (6 French, 7 French, or 10 French at the discretion of the endoscopist) will be deployed over the wire.~LAMS plus double pigtail stent: The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent."
11301559|NCT03049215|BG002|Baseline|Total|Total of all reporting groups
11301560|NCT03049215|FG000|Participant Flow|Lumen Apposing Metal Stent (LAMS)|"Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter.~Lumen Apposing Metal Stent (LAMS): The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst."
11301561|NCT03049215|FG001|Participant Flow|LAMS Plus Double Pigtail Stent|"Subjects randomized to LAMS plus double pigtail stent will undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter. Following this, wire access across the stent lumen will be achieved using a 0.035 inch hydrophilic guidewire, and a double pigtail plastic biliary stent (6 French, 7 French, or 10 French at the discretion of the endoscopist) will be deployed over the wire.~LAMS plus double pigtail stent: The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent."
11301562|NCT03049215|OG000|Outcome|Lumen Apposing Metal Stent (LAMS)|"Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter.~Lumen Apposing Metal Stent (LAMS): The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst."
11301563|NCT03049215|OG001|Outcome|LAMS Plus Double Pigtail Stent|"Subjects randomized to LAMS plus double pigtail stent will undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter. Following this, wire access across the stent lumen will be achieved using a 0.035 inch hydrophilic guidewire, and a double pigtail plastic biliary stent (6 French, 7 French, or 10 French at the discretion of the endoscopist) will be deployed over the wire.~LAMS plus double pigtail stent: The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent."
11301564|NCT03049215|EG000|Reported Event|Lumen Apposing Metal Stent (LAMS)|"Subjects randomized to LAMS alone will undergo EUS-guided transmural placement of an Axios stent with a 15 mm luminal diameter.~Lumen Apposing Metal Stent (LAMS): The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst."
11301565|NCT03049215|EG001|Reported Event|LAMS Plus Double Pigtail Stent|"Subjects randomized to LAMS plus double pigtail stent will undergo EUS-guided transmural placement of a single Axios stent with a 15 mm luminal diameter. Following this, wire access across the stent lumen will be achieved using a 0.035 inch hydrophilic guidewire, and a double pigtail plastic biliary stent (6 French, 7 French, or 10 French at the discretion of the endoscopist) will be deployed over the wire.~LAMS plus double pigtail stent: The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent."
11301566|NCT03049280|BG000|Baseline|TORS|Subjects that underwent transoral otolaryngology robotic surgery
11301567|NCT03049280|FG000|Participant Flow|TORS|Subjects that underwent transoral otolaryngology robotic surgery
11301568|NCT03049280|OG000|Outcome|TORS|subjects undergoing transoral otolaryngology robotic surgery
11301569|NCT03049280|OG000|Outcome|TORS|Subjects that underwent transoral otolaryngology robotic surgery
11301570|NCT03049280|OG000|Outcome|TORS|Subject undergoing transoral otolaryngology robotic surgery
11301571|NCT03049280|EG000|Reported Event|TORS|Subjects that underwent transoral otolaryngology robotic surgery
11301572|NCT03049488|BG000|Baseline|Group 1: DS-Cav1 (50 mcg)|"DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301573|NCT03049488|BG001|Baseline|Group 2: DS-Cav1 (50 mcg) + Alum|"DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301574|NCT03049488|BG002|Baseline|Group 3: DS-Cav1 (150 mcg)|"DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301575|NCT03049488|BG003|Baseline|Group 4: DS-Cav1 (150 mcg) + Alum|"DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301576|NCT03049488|BG004|Baseline|Group 5: DS-Cav1 (500 mcg)|"DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301577|NCT03049488|BG005|Baseline|Group 6: DS-Cav1 (500 mcg) + Alum|"DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301578|NCT03049488|BG006|Baseline|Total|Total of all reporting groups
11301579|NCT03049488|FG000|Participant Flow|Group 1: DS-Cav1 (50 mcg)|"DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301580|NCT03049488|FG001|Participant Flow|Group 2: DS-Cav1 (50 mcg) + Alum|"DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11217552|NCT02314247|EG001|Reported Event|Selinexor (CTCL)|"Assigned to 60 mg; 6 doses/cycle (6 patients)~Assigned to 60 mg; 8 doses/cycle (1 patient)"
11217553|NCT02314260|BG000|Baseline|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital's standard protocol."
11217554|NCT02314260|FG000|Participant Flow|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital's standard protocol."
11217555|NCT02314260|OG000|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital's standard protocol."
11217556|NCT02314260|EG000|Reported Event|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital's standard protocol."
11217557|NCT02314403|BG000|Baseline|Combined Bone Marrow and Kidney Transplantation|"Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.~Belatacept: A selective T-cell (lymphocyte) costimulation blocker~ATG: A T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation~Thymic Irradiation~Combined Bone Marrow/Kidney Transplantation"
11217558|NCT02314403|FG000|Participant Flow|Combined Bone Marrow and Kidney Transplantation|"Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.~Belatacept: A selective T-cell (lymphocyte) costimulation blocker~ATG: A T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation~Thymic Irradiation~Combined Bone Marrow/Kidney Transplantation"
11217559|NCT02314403|OG000|Outcome|Combined Bone Marrow and Kidney Transplantation|"Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.~Belatacept: A selective T-cell (lymphocyte) costimulation blocker~ATG: A T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation~Thymic Irradiation~Combined Bone Marrow/Kidney Transplantation"
11217560|NCT02314403|EG000|Reported Event|Combined Bone Marrow and Kidney Transplantation|"Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.~Belatacept: A selective T-cell (lymphocyte) costimulation blocker~ATG: A T-Cell Depleting Agent~Rituximab: B-Cell Depleting Agent~Total Body Irradiation~Thymic Irradiation~Combined Bone Marrow/Kidney Transplantation"
11217561|NCT02314520|BG000|Baseline|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
11217562|NCT02314520|BG001|Baseline|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
11217563|NCT02314520|BG002|Baseline|Total|Total of all reporting groups
11301581|NCT03049488|FG002|Participant Flow|Group 3: DS-Cav1 (150 mcg)|"DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301582|NCT03049488|FG003|Participant Flow|Group 4: DS-Cav1 (150 mcg) + Alum|"DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301583|NCT03049488|FG004|Participant Flow|Group 5: DS-Cav1 (500 mcg)|"DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301584|NCT03049488|FG005|Participant Flow|Group 6: DS-Cav1 (500 mcg) + Alum|"DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301585|NCT03049488|OG000|Outcome|Group 1: DS-Cav1 (50 mcg)|"DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301586|NCT03049488|OG001|Outcome|Group 2: DS-Cav1 (50 mcg) + Alum|"DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301587|NCT03049488|OG002|Outcome|Group 3: DS-Cav1 (150 mcg)|"DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301588|NCT03049488|OG003|Outcome|Group 4: DS-Cav1 (150 mcg) + Alum|"DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301589|NCT03049488|OG004|Outcome|Group 5: DS-Cav1 (500 mcg)|"DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301590|NCT03049488|OG005|Outcome|Group 6: DS-Cav1 (500 mcg) + Alum|"DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301591|NCT03049488|OG006|Outcome|All DS-Cav1 Dose Groups|DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
11301592|NCT03049488|EG000|Reported Event|Group 1: DS-Cav1 (50 mcg)|"DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301593|NCT03049488|EG001|Reported Event|Group 2: DS-Cav1 (50 mcg) + Alum|"DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301594|NCT03049488|EG002|Reported Event|Group 3: DS-Cav1 (150 mcg)|"DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301595|NCT03049488|EG003|Reported Event|Group 4: DS-Cav1 (150 mcg) + Alum|"DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301596|NCT03049488|EG004|Reported Event|Group 5: DS-Cav1 (500 mcg)|"DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine."
11301597|NCT03049488|EG005|Reported Event|Group 6: DS-Cav1 (500 mcg) + Alum|"DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)~*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.~VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.~Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant."
11301598|NCT03049501|BG000|Baseline|Caregiving Condition|"Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics~Caregiving condition"
11301599|NCT03049501|BG001|Baseline|Nutrition Condition|"Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition~Nutrition condition"
11301600|NCT03049501|BG002|Baseline|Total|Total of all reporting groups
11301601|NCT03049501|FG000|Participant Flow|Caregiving Condition|"Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics~Caregiving condition"
11301602|NCT03049501|FG001|Participant Flow|Nutrition Condition|"Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition~Nutrition condition"
11301603|NCT03049501|OG000|Outcome|Caregiving Condition|"Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics~Caregiving condition"
11301604|NCT03049501|OG001|Outcome|Nutrition Condition|"Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition~Nutrition condition"
11301605|NCT03049501|EG000|Reported Event|Caregiving Condition|"Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics~Caregiving condition"
11301606|NCT03049501|EG001|Reported Event|Nutrition Condition|"Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition~Nutrition condition"
11301607|NCT03049748|BG000|Baseline|Control Group|Participants in the control group (20 LVAD patients) received usual care over 6 months. Usual care consisted routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training provided to patients and caregivers before hospital discharge and as need throughout the duration of the study.
11301608|NCT03049748|BG001|Baseline|Intervention Group|Participants in the experimental group (20 LVAD patients) received usual care plus VAD Care App described in previous sections. They implemented LVAD self-management as directed by the app daily by patients and/or caregivers for over 6 months. Patient LVAD care self-management competencies were assessed at months 1 and 5 post hospital discharge with a review of LVAD care self-management skills provided by the LVAD RN Coordinator.
11301609|NCT03049748|BG002|Baseline|Total|Total of all reporting groups
11301610|NCT03049748|FG000|Participant Flow|Control Group|"Participants in the control group (20 LVAD patients and 20 caregivers) will receive usual care over 6 months. Usual care consists of routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training will be provided to patients and caregiver before hospital discharge and as need throughout the duration of the study. The control group will NOT receive the VAD Care App.~Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge and as needed throughout the duration of the study."
11301611|NCT03049748|FG001|Participant Flow|Intervention Group|"Participants in the experimental group (20 LVAD patients and 20 caregivers) will receive usual care plus VAD Care App. They will implement LVAD self-management as directed by VAD Care App. The app will be used daily by patients and/or caregivers for over 6 months. Their LVAD self-management competencies will be assessed at months 1 and 5 post hospital discharge with a review of LVAD self-management skills provided by the LVAD RN Coordinator.~Mobile phone app (VAD Care App): VAD Care App is a novel self-management tool being tested for patients with implantable LVADs. The app has daily push notifications (alerts), cues for daily self-management tasks, two-way communication using text messages and videoconferencing (virtual clinic), and links to LVAD self-management skills and videos easily accessible for self-management skill review.~Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge"
11301612|NCT03049748|OG000|Outcome|Control Group|Participants in the control group (20 LVAD patients) received usual care over 6 months. Usual care consisted routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training provided to patients and caregivers before hospital discharge and as need throughout the duration of the study.
11301613|NCT03049748|OG001|Outcome|Intervention Group|Participants in the experimental group (20 LVAD patients) received usual care plus VAD Care App described in previous sections. They implemented LVAD self-management as directed by the app daily by patients and/or caregivers for over 6 months. Patient LVAD care self-management competencies were assessed at months 1 and 5 post hospital discharge with a review of LVAD care self-management skills provided by the LVAD RN Coordinator.
11301614|NCT03049748|EG000|Reported Event|Control Group|"Participants in the control group (20 LVAD patients) will receive usual care over 6 months. Usual care consists of routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training will be provided to patients and caregiver before hospital discharge and as need throughout the duration of the study. The control group will NOT receive the VAD Care App.~Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge and as needed throughout the duration of the study."
11301615|NCT03049748|EG001|Reported Event|Intervention Group|"Participants in the experimental group (20 LVAD patients) will receive usual care plus VAD Care App. They will implement LVAD self-management as directed by VAD Care App. The app will be used daily by patients and/or caregivers for over 6 months. Their LVAD self-management competencies will be assessed at months 1 and 5 post hospital discharge with a review of LVAD self-management skills provided by the LVAD RN Coordinator.~Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge and as needed thro"
11301616|NCT03049852|BG000|Baseline|CBT-001 Ophthalmic Solution Single Dose|"One drop in the study administered one time~CBT-001: One drop in the study administered one time"
11301617|NCT03049852|BG001|Baseline|Vehicle Multi-dose|"One drop in the study administered three times daily (TID) for 4 weeks~Vehicle: One drop in the study administered three times daily (TID) for 4 weeks"
11301618|NCT03049852|BG002|Baseline|CBT-001 Ophthalmic Solution Multi-dose|"One drop in the study administered three times daily (TID) for 4 weeks~CBT-001: One drop in the study administered three times daily (TID) for 4 weeks"
11301619|NCT03049852|BG003|Baseline|Total|Total of all reporting groups
11301620|NCT03049852|FG000|Participant Flow|CBT-001 Ophthalmic Solution Single Dose|CBT-001 Ophthalmic Solution Single dose in one day
11301621|NCT03049852|FG001|Participant Flow|Vehicle Multi-dose|One drop in the study administered three times daily (TID) for 4 weeks
11301622|NCT03049852|FG002|Participant Flow|CBT-001 Ophthalmic Solution Multi-dose|One drop in the study administered three times daily (TID) for 4 weeks
11301623|NCT03049852|OG000|Outcome|Vehicle Multi-dose|"One drop in the study administered three times daily (TID)~Vehicle: One drop in the study administered three times daily (TID) for 4 weeks"
11301624|NCT03049852|OG001|Outcome|CBT-001 Ophthalmic Solution Multi-dose|"One drop in the study administered three times daily (TID)~CBT-001: One drop in the study administered three times daily (TID) for 4 weeks"
11301625|NCT03049852|OG000|Outcome|CBT-001 Ophthalmic Solution Single Dose|"One drop in the study administered one time~One drop in the study administered one time in one day"
11301626|NCT03049852|OG000|Outcome|CBT-001 Ophthalmic Solution|"One drop in the study administered three times daily (TID)~CBT-001: One drop in the study administered three times daily (TID)"
11301627|NCT03049852|OG001|Outcome|Vehicle|"One drop in the study administered three times daily (TID)~Vehicle: One drop in the study administered three times daily (TID)"
11301628|NCT03049852|EG000|Reported Event|CBT-001 Ophthalmic Solution Single Dose|"One drop in the study administered one time~One drop in the study administered one time in one day"
11301629|NCT03049852|EG001|Reported Event|Vehicle Multi-dose|"One drop in the study administered three times daily (TID)~Vehicle: One drop in the study administered three times daily (TID) for 4 weeks"
11301630|NCT03049852|EG002|Reported Event|CBT-001 Ophthalmic Solution Multi-dose|"One drop in the study administered three times daily (TID)~CBT-001: One drop in the study administered three times daily (TID) for 4 weeks"
11301631|NCT03049917|BG000|Baseline|No Incentive|KES financial incentive= $0
11301632|NCT03049917|BG001|Baseline|KES Financial Incentive 1|KES financial incentive 1= $1.25
11301633|NCT03049917|BG002|Baseline|KES Financial Incentive 2|KES financial incentive 2= $2.50
11301634|NCT03049917|BG003|Baseline|KES Financial Incentive 3|KES financial incentive 3= $5
11301635|NCT03049917|BG004|Baseline|KES Financial Incentive 4|KES financial incentive 4= $10
11301636|NCT03049917|BG005|Baseline|Total|Total of all reporting groups
11301637|NCT03049917|FG000|Participant Flow|No Incentive|KES financial incentive = $0
11301638|NCT03049917|FG001|Participant Flow|KES Financial Incentive 1|KES financial incentive 1= $1.25
11301639|NCT03049917|FG002|Participant Flow|KES Financial Incentive 2|KES financial incentive 2= $2.50
11301640|NCT03049917|FG003|Participant Flow|KES Financial Incentive 3|KES financial incentive 3= $5
11301641|NCT03049917|FG004|Participant Flow|KES Financial Incentive 4|KES financial incentive 4= $10
11301642|NCT03049917|OG000|Outcome|No Incentive|KES financial incentive=$0
11301643|NCT03049917|OG001|Outcome|KES Financial Incentive 1|KES financial incentive 1=$1.25
11301644|NCT03049917|OG002|Outcome|KES Financial Incentive 2|KES financial incentive 2=$2.50
11301645|NCT03049917|OG003|Outcome|KES Financial Incentive 3|KES financial incentive 3=$5
11301646|NCT03049917|OG004|Outcome|KES Financial Incentive 4|KES financial incentive 4=$10
11301647|NCT03049917|OG000|Outcome|No Incentive|KES financial incentive =$0
11301648|NCT03049917|OG001|Outcome|KES Financial Incentive 1|KES financial incentive 1=$1.25 Females
11301649|NCT03049917|OG002|Outcome|KES Financial Incentive 2|KES financial incentive 2: $2.50 Females
11301650|NCT03049917|OG003|Outcome|KES Financial Incentive 3|KES financial incentive 3:$5 Females
11301651|NCT03049917|OG004|Outcome|KES Financial Incentive 4|KES financial incentive 4:$10 Females
11301652|NCT03049917|OG005|Outcome|All Females|Total females enrolled
11301653|NCT03049917|OG002|Outcome|KES Financial Incentive 2|KES financial incentive 2:$2.50 Females
11301654|NCT03049917|OG005|Outcome|All Males|Total males enrolled
11301655|NCT03049917|OG002|Outcome|KES Financial Incentive 2|KES financial incentive 2=$2.50 Females
11301656|NCT03049917|OG003|Outcome|KES Financial Incentive 3|KES financial incentive 3=$5 Females
11301657|NCT03049917|OG004|Outcome|KES Financial Incentive 4|"KES financial incentive 1=$10~Females"
11301658|NCT03049917|OG005|Outcome|All With One Child|Caregivers with one child
11301659|NCT03049917|OG004|Outcome|KES Financial Incentive 4|KES financial incentive 4=$10 Females
11301660|NCT03049917|OG005|Outcome|All With More Than One Child|All families with more than one child
11301661|NCT03049917|OG000|Outcome|No Incentive|No incentive upon HIV testing for child
11301662|NCT03049917|OG001|Outcome|KES Financial Incentive 1|"Kenyan Shillings conditional cash transfer upon HIV testing~Financial incentive: Conditional cash transfer upon HIV testing~Females"
11301663|NCT03049917|OG002|Outcome|KES Financial Incentive 2|"Kenyan Shillings conditional cash transfer upon HIV testing~Financial incentive: Conditional cash transfer upon HIV testing~Females"
11301664|NCT03049917|OG003|Outcome|KES Financial Incentive 3|"Kenyan Shillings conditional cash transfer upon HIV testing~Financial incentive: Conditional cash transfer upon HIV testing~Females"
11301665|NCT03049917|OG004|Outcome|KES Financial Incentive 4|"Kenyan Shillings conditional cash transfer upon HIV testing~Financial incentive: Conditional cash transfer upon HIV testing~Females"
11301666|NCT03049917|OG005|Outcome|All With Caregiver Age <=38 Years|Uptake of testing if Caregiver age <=38 years
11301667|NCT03049917|OG000|Outcome|No Incentive|No incentive with uptake of child HIV testing
11301668|NCT03049917|OG005|Outcome|All With Caregiver Age >38 Years|Uptake of testing if Caregiver age >38 years
11301669|NCT03049917|EG000|Reported Event|No Incentive|KES financial incentive = $0
11301670|NCT03049917|EG001|Reported Event|KES Financial Incentive 1|KES financial incentive 1= $1.25
11301671|NCT03049917|EG002|Reported Event|KES Financial Incentive 2|KES financial incentive 2= $2.50
11301672|NCT03049917|EG003|Reported Event|KES Financial Incentive 3|KES financial incentive 3= $5
11301673|NCT03049917|EG004|Reported Event|KES Financial Incentive 4|KES financial incentive 4= $10
11301674|NCT03050203|BG000|Baseline|Custom Pack|custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
11301675|NCT03050203|BG001|Baseline|Standard Care|standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
11301676|NCT03050203|BG002|Baseline|Total|Total of all reporting groups
11301677|NCT03050203|FG000|Participant Flow|Custom Pack|custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
11301678|NCT03050203|FG001|Participant Flow|Standard Care|standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
11301679|NCT03050203|OG000|Outcome|Custom Pack|custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
11301680|NCT03050203|OG001|Outcome|Standard Care|standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
11301681|NCT03050203|EG000|Reported Event|Custom Pack|custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
11301682|NCT03050203|EG001|Reported Event|Standard Care|standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
11301683|NCT03050216|BG000|Baseline|Cy, FLU, Haplo NK and ALT-803|Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
11301684|NCT03050216|FG000|Participant Flow|Cy, FLU, Haplo NK and ALT-803|Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
11301685|NCT03050216|OG000|Outcome|Cy, FLU, Haplo NK and ALT-803|Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
11301686|NCT03050216|EG000|Reported Event|Cy, FLU, Haplo NK and ALT-803|Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
11301687|NCT03050294|BG000|Baseline|Control- Atopic Dermatitis|"Participants with atopic dermatitis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301688|NCT03050294|BG001|Baseline|Atopic Dermatitis Intervention|"Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301689|NCT03050294|BG002|Baseline|Control- Psoriasis|"Participants with psoriasis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301690|NCT03050294|BG003|Baseline|Psoriasis Intervention|"Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301691|NCT03050294|BG004|Baseline|Total|Total of all reporting groups
11301692|NCT03050294|FG000|Participant Flow|Control- Atopic Dermatitis|"Participants with atopic dermatitis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301693|NCT03050294|FG001|Participant Flow|Atopic Dermatitis Intervention|"Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301694|NCT03050294|FG002|Participant Flow|Control- Psoriasis|"Participants with psoriasis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301695|NCT03050294|FG003|Participant Flow|Psoriasis Intervention|"Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301696|NCT03050294|OG000|Outcome|Control- Atopic Dermatitis|"Participants with atopic dermatitis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301697|NCT03050294|OG001|Outcome|Atopic Dermatitis Intervention|"Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301698|NCT03050294|OG000|Outcome|Control- Psoriasis|"Participants with psoriasis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301699|NCT03050294|OG001|Outcome|Psoriasis Intervention|"Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301700|NCT03050294|EG000|Reported Event|Control- Atopic Dermatitis|"Participants with atopic dermatitis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301701|NCT03050294|EG001|Reported Event|Atopic Dermatitis Intervention|"Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301702|NCT03050294|EG002|Reported Event|Control- Psoriasis|"Participants with psoriasis will receive desoximetasone and no calls.~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301703|NCT03050294|EG003|Reported Event|Psoriasis Intervention|"Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.~Phone calls: Phone calls twice daily~Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily"
11301704|NCT03050307|BG000|Baseline|TAK-438 20 mg|Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
11301705|NCT03050307|BG001|Baseline|Lansoprazole 30 mg|HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
11301706|NCT03050307|BG002|Baseline|Total|Total of all reporting groups
11301707|NCT03050307|FG000|Participant Flow|TAK-438 20 mg|Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
11301708|NCT03050307|FG001|Participant Flow|Lansoprazole 30 mg|HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
11301709|NCT03050307|OG000|Outcome|TAK-438 20 mg|Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
11301710|NCT03050307|OG001|Outcome|Lansoprazole 30 mg|HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
11301711|NCT03050307|OG000|Outcome|TAK-438 20 mg|Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks.
11301712|NCT03050307|OG001|Outcome|Lansoprazole 30 mg|HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks.
11301713|NCT03050307|EG000|Reported Event|TAK-438 20 mg|Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
11301714|NCT03050307|EG001|Reported Event|Lansoprazole 30 mg|HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
11301715|NCT03050320|BG000|Baseline|Exercise|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301716|NCT03050320|BG001|Baseline|No Exercise|"The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301717|NCT03050320|BG002|Baseline|Total|Total of all reporting groups
11301718|NCT03050320|FG000|Participant Flow|Exercise|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301719|NCT03050320|FG001|Participant Flow|No Exercise|"The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301720|NCT03050320|OG000|Outcome|Exercise|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301721|NCT03050320|OG001|Outcome|No Exercise|"The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301722|NCT03050320|EG000|Reported Event|Exercise|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301723|NCT03050320|EG001|Reported Event|No Exercise|"The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
11301724|NCT03050359|BG000|Baseline|TAK-438 20 mg|HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
11301725|NCT03050359|BG001|Baseline|Lansoprazole 30 mg|HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
11301726|NCT03050359|BG002|Baseline|Total|Total of all reporting groups
11301727|NCT03050359|FG000|Participant Flow|TAK-438 20 mg|H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
11301728|NCT03050359|FG001|Participant Flow|Lansoprazole 30 mg|H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
11301729|NCT03050359|OG000|Outcome|TAK-438 20 mg|HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
11301730|NCT03050359|OG001|Outcome|Lansoprazole 30 mg|HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
11301731|NCT03050359|OG000|Outcome|TAK-438 20 mg|HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
11301732|NCT03050359|OG001|Outcome|Lansoprazole 30 mg|HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
11301733|NCT03050359|EG000|Reported Event|TAK-438 20 mg|HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
11301734|NCT03050359|EG001|Reported Event|Lansoprazole 30 mg|HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
11301735|NCT03050372|BG000|Baseline|All Study Participants|"Participants are randomized to receive either two consecutive nights of Active Low Field Magnetic Stimulation followed by Sham Low Field Magnetic Stimulation or vice versa.~Active Low Field Magnetic Stimulation LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)~Sham Low Field Magnetic Stimulation LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)"
11301736|NCT03050372|FG000|Participant Flow|Active Low Field Magnetic Stimulation (LFMS), Then Sham LFMS|"Adaptation Night; then two consecutive nights of Active LFMS; after washout two consecutive nights of Sham LFMS~LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab~LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab"
11301737|NCT03050372|FG001|Participant Flow|Sham Low Field Magnetic Stimulation (LFMS), Then Active LFMS|"Adaptation Night; then two consecutive nights of Sham LFMS; after washout followed by two consecutive nights of Active LFMS~LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab~LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab"
11301738|NCT03050372|OG000|Outcome|Active Low Field Magnetic Stimulation|"LFMS - Active~LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)"
11301739|NCT03050372|OG001|Outcome|Sham Low Field Magnetic Stimulation|"LFMS - Sham~LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)"
11217564|NCT02314520|FG000|Participant Flow|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
11217565|NCT02314520|FG001|Participant Flow|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
11217566|NCT02314520|OG000|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
11217567|NCT02314520|OG001|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
11217568|NCT02314520|EG000|Reported Event|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.~peripherally inserted central catheter: Any complication associated with central access"
11217569|NCT02314520|EG001|Reported Event|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.~centrally inserted central catheter: Central access not associated with any complication"
11217570|NCT02314546|BG000|Baseline|Saline Placebo|Control patients received intranasal saline.
11217571|NCT02314546|BG001|Baseline|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11217572|NCT02314546|BG002|Baseline|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11217573|NCT02314546|BG003|Baseline|Total|Total of all reporting groups
11217574|NCT02314546|FG000|Participant Flow|Saline Placebo|Control patients received intranasal saline.
11217575|NCT02314546|FG001|Participant Flow|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11217576|NCT02314546|FG002|Participant Flow|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11217577|NCT02314546|OG000|Outcome|Saline Placebo|Control patients received intranasal saline.
11217578|NCT02314546|OG001|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11217579|NCT02314546|OG002|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11217580|NCT02314546|OG000|Outcome|Saline Placebo|Control patients will received intranasal saline.
11217581|NCT02314546|EG000|Reported Event|Saline Placebo|Control patients received intranasal saline.
11217582|NCT02314546|EG001|Reported Event|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11217583|NCT02314546|EG002|Reported Event|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11217584|NCT02314598|BG000|Baseline|All Study Participants|Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
11217585|NCT02314598|FG000|Participant Flow|All Study Participants|Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
11217586|NCT02314598|OG000|Outcome|All Study Participants|Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
11217587|NCT02314598|EG000|Reported Event|All Study Participants|Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
11217588|NCT02314637|BG000|Baseline|Teneligliptin|Teneligliptin for 52 weeks
11217589|NCT02314637|BG001|Baseline|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11217590|NCT02314637|BG002|Baseline|Total|Total of all reporting groups
11217591|NCT02314637|FG000|Participant Flow|Teneligliptin|Teneligliptin for 52 weeks
11217592|NCT02314637|FG001|Participant Flow|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
11217593|NCT02314637|OG000|Outcome|Teneligliptin|Teneligliptin for 52 weeks
11217594|NCT02314637|OG001|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11217595|NCT02314637|EG000|Reported Event|Teneligliptin|Teneligliptin for 52 weeks
11217596|NCT02314637|EG001|Reported Event|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11217597|NCT02314689|BG000|Baseline|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11217598|NCT02314689|FG000|Participant Flow|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11301740|NCT03050372|EG000|Reported Event|Entire Study Population|"All participants completed an adaptation night (night #1) in the sleep lab including baseline assessment. Participants were treatment randomized to receive, after the adaptation night in the sleep lab, either two consecutive nights (night #2,#3) of Active Low Field Magnetic Stimulation followed by two consecutive nights (night #4,#5) of Sham Low Field Magnetic Stimulation, or vice versa. A washout period was permitted between nights #3 and #4 when the intervention changed.~Interventions:~Active Low Field Magnetic Stimulation A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (20 minutes before sleep)~Sham Low Field Magnetic Stimulation A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (20 minutes before sleep)"
11301741|NCT03050450|BG000|Baseline|Dose Level 1|"25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11217599|NCT02314689|OG000|Outcome|IV Citrulline|"IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.~Intravenous (IV) citrulline"
11217600|NCT02314689|EG000|Reported Event|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11217601|NCT02314728|BG000|Baseline|Vaginal Misoprostol|"PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score </= 6.~Women with PROM randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25 mcg transvaginal every 4 hours as per hospital protocol.~Misoprostol: Women with PROM who are randomized to receive misoprostol will have 25 mcg placed vaginally."
11217602|NCT02314728|BG001|Baseline|Oxytocin Alone|"PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score </= 6.~Women randomized to the oxytocin arm will receive infusion of oxytocin that is titrated as per hospital protocol, and until adequate uterine contractions are achieved.~Oxytocin: Women with PROM who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. The hospital protocol begins with 2 milliunits of oxytocin that is then titrated upward by 2 millunits every 20-30 minutes until adequate contractions that cause cervical change is obtained. Titration is based on hospital protocol, clinical examination and clinical judgment of the provider, and is continued until there are adequate uterine contractions that cause the cervix to change until delivery."
11217603|NCT02314728|BG002|Baseline|Total|Total of all reporting groups
11217604|NCT02314728|FG000|Participant Flow|Vaginal Misoprostol|"PROM >/= 34 weeks~Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.~Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally."
11217605|NCT02314728|FG001|Participant Flow|Oxytocin Alone|"PROM >/= 34 weeks~Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.~Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery."
11217606|NCT02314728|OG000|Outcome|Vaginal Misoprostol|"PROM greater than or equal to 34 weeks of gestation~Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.~Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally."
11217607|NCT02314728|OG001|Outcome|Oxytocin Alone|"PROM greater than or equal to 34 weeks of gestation~Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.~Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery."
11217608|NCT02314728|OG000|Outcome|Vaginal Misoprostol|"PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score </= 6.~Women with PROM randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25 mcg transvaginal every 4 hours as per hospital protocol.~Misoprostol: Women with PROM who are randomized to receive misoprostol will have 25 mcg placed vaginally."
11217609|NCT02314728|OG001|Outcome|Oxytocin Alone|"PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score </= 6.~Women randomized to the oxytocin arm will receive infusion of oxytocin that is titrated as per hospital protocol, and until adequate uterine contractions are achieved.~Oxytocin: Women with PROM who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. The hospital protocol begins with 2 milliunits of oxytocin that is then titrated upward by 2 millunits every 20-30 minutes until adequate contractions that cause cervical change is obtained. Titration is based on hospital protocol, clinical examination and clinical judgment of the provider, and is continued until there are adequate uterine contractions that cause the cervix to change until delivery."
11217610|NCT02314728|EG000|Reported Event|Misoprostol|"Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.~Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider."
11217611|NCT02314728|EG001|Reported Event|Oxytocin Alone|"Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.~Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions."
11301742|NCT03050450|BG001|Baseline|Dose Level 2|"50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301743|NCT03050450|BG002|Baseline|Dose Level 3|"100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301744|NCT03050450|BG003|Baseline|Dose Level 4|"150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301745|NCT03050450|BG004|Baseline|Dose Level 5|"150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301746|NCT03050450|BG005|Baseline|Total|Total of all reporting groups
11301747|NCT03050450|FG000|Participant Flow|Dose Level 1|"25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301748|NCT03050450|FG001|Participant Flow|Dose Level 2|"50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301749|NCT03050450|FG002|Participant Flow|Dose Level 3|"100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301750|NCT03050450|FG003|Participant Flow|Dose Level 4|"150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301751|NCT03050450|FG004|Participant Flow|Dose Level 5|"150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301752|NCT03050450|OG000|Outcome|Dose Level 1|"25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301753|NCT03050450|OG001|Outcome|Dose Level 2|"50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301754|NCT03050450|OG002|Outcome|Dose Level 3|"100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301755|NCT03050450|OG003|Outcome|Dose Level 4|"150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301756|NCT03050450|OG004|Outcome|Dose Level 5|"150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301757|NCT03050450|EG000|Reported Event|Dose Level 1|"25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301758|NCT03050450|EG001|Reported Event|Dose Level 2|"50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301759|NCT03050450|EG002|Reported Event|Dose Level 3|"100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301760|NCT03050450|EG003|Reported Event|Dose Level 4|"150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301761|NCT03050450|EG004|Reported Event|Dose Level 5|"150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)~150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle"
11301762|NCT03050541|BG000|Baseline|Healthy Adult Volunteers-Oral MDMA at Memory Encoding|"20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301763|NCT03050541|BG001|Baseline|Healthy Adult Volunteers-Oral MDMA at Memory Retrievial|"20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301764|NCT03050541|BG002|Baseline|Healthy Adult Volunteers-Placebo at Both Sessions|"20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.~Placebo"
11301765|NCT03050541|BG003|Baseline|Total|Total of all reporting groups
11301766|NCT03050541|FG000|Participant Flow|MDMA at Memory Encoding|"20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301767|NCT03050541|FG001|Participant Flow|MDMA at Memory Retrievial|"20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301768|NCT03050541|FG002|Participant Flow|Placebo at Both Sessions|"20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.~Placebo"
11301769|NCT03050541|OG000|Outcome|Healthy Adult Volunteers-Oral MDMA at Memory Encoding|"20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301770|NCT03050541|OG001|Outcome|Healthy Adult Volunteers-Oral MDMA at Memory Retrievial|"20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301771|NCT03050541|OG002|Outcome|Healthy Adult Volunteers-Placebo at Both Sessions|"20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.~Placebo"
11301772|NCT03050541|EG000|Reported Event|Healthy Adult Volunteers-Oral MDMA at Memory Encoding|"20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301773|NCT03050541|EG001|Reported Event|Healthy Adult Volunteers-Oral MDMA at Memory Retrievial|"20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..~Oral MDMA: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.~Placebo"
11301774|NCT03050541|EG002|Reported Event|Healthy Adult Volunteers-Placebo at Both Sessions|"20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.~Placebo"
11301775|NCT03050619|BG000|Baseline|Empagliflozin|Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.
11301776|NCT03050619|BG001|Baseline|Other SGLT-2i|Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.
11301777|NCT03050619|BG002|Baseline|Dipeptidyl Peptidase-4 Inhibitors (DPP-4i)|Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.
11301778|NCT03050619|BG003|Baseline|Metformin|Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.
11301779|NCT03050619|BG004|Baseline|Sulfonylureas (SU)|Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.
11301780|NCT03050619|BG005|Baseline|Glucagon-like Peptide-1 (GLP-1) Agonists|Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
11301781|NCT03050619|BG006|Baseline|Total|Total of all reporting groups
11301782|NCT03050619|FG000|Participant Flow|Empagliflozin|Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.
11301783|NCT03050619|FG001|Participant Flow|Other SGLT-2i|Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.
11301784|NCT03050619|FG002|Participant Flow|Dipeptidyl Peptidase-4 Inhibitors (DPP-4i)|Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.
11301785|NCT03050619|FG003|Participant Flow|Metformin|Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.
11301786|NCT03050619|FG004|Participant Flow|Sulfonylureas (SU)|Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.
11301787|NCT03050619|FG005|Participant Flow|Glucagon-like Peptide-1 (GLP-1) Agonists|Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
11301788|NCT03050619|OG000|Outcome|Empagliflozin|Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.
11301789|NCT03050619|OG001|Outcome|Other SGLT-2i|Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.
11301790|NCT03050619|OG002|Outcome|Dipeptidyl Peptidase-4 Inhibitors (DPP-4i)|Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.
11301791|NCT03050619|OG003|Outcome|Metformin|Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.
11301792|NCT03050619|OG004|Outcome|Sulfonylureas (SU)|Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.
11301793|NCT03050619|OG005|Outcome|Glucagon-like Peptide-1 (GLP-1) Agonists|Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
11301794|NCT03050619|EG000|Reported Event|Empagliflozin|Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.
11301795|NCT03050619|EG001|Reported Event|Other SGLT-2i|Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.
11301796|NCT03050619|EG002|Reported Event|Dipeptidyl Peptidase-4 Inhibitors (DPP-4i)|Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.
11301797|NCT03050619|EG003|Reported Event|Metformin|Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.
11301798|NCT03050619|EG004|Reported Event|Sulfonylureas (SU)|Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.
11301799|NCT03050619|EG005|Reported Event|Glucagon-like Peptide-1 (GLP-1) Agonists|Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
11301800|NCT03050697|BG000|Baseline|HMTIOL|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301801|NCT03050697|FG000|Participant Flow|HMTIOL|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301802|NCT03050697|OG000|Outcome|HMTIOL|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301803|NCT03050697|OG000|Outcome|HMTIOL - Day 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301804|NCT03050697|OG001|Outcome|HMTIOL - Week 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301805|NCT03050697|OG002|Outcome|HMTIOL - Month 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301806|NCT03050697|OG003|Outcome|HMTIOL - Month 3 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301807|NCT03050697|OG000|Outcome|HMTIOL - Baseline (Day 0 Preoperative)|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301808|NCT03050697|OG001|Outcome|HMTIOL - Day 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301809|NCT03050697|OG002|Outcome|HMTIOL - Week 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301810|NCT03050697|OG003|Outcome|HMTIOL - Month 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301811|NCT03050697|OG004|Outcome|HMTIOL - Month 3 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301812|NCT03050697|OG000|Outcome|HMTIOL - Month 1 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301813|NCT03050697|OG001|Outcome|HMTIOL - Month 3 Postoperative|HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
11301814|NCT03050697|EG000|Reported Event|HMTIOL - Nonocular AEs|All subjects with attempted study lens implantation (successful or aborted after contact with the eye)
11301815|NCT03050697|EG001|Reported Event|HMTIOL - Ocular AEs|All eyes with attempted study lens implantation (successful or aborted after contact with the eye)
11301816|NCT03050775|BG000|Baseline|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
11301817|NCT03050775|BG001|Baseline|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
11301818|NCT03050775|BG002|Baseline|Total|Total of all reporting groups
11301819|NCT03050775|FG000|Participant Flow|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
11301820|NCT03050775|FG001|Participant Flow|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
11301821|NCT03050775|OG000|Outcome|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
11301822|NCT03050775|OG001|Outcome|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
11301823|NCT03050775|EG000|Reported Event|Heated Ventilator Circuit|"Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.~Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger"
11301824|NCT03050775|EG001|Reported Event|Standard Ventilator Circuit|"Standard ventilation and temperature management~Standard Ventilator Circuit: no active heat and humidification during anesthesia"
11301825|NCT03050801|BG000|Baseline|Experiment 1: Parietal Cortex rTMS Stimulation - 1 Day|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 1 day"
11301826|NCT03050801|BG001|Baseline|Experiment 1: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301827|NCT03050801|BG002|Baseline|Experiment 1: Parietal Cortex rTMS Stimulation - 4 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 4 days"
11301828|NCT03050801|BG003|Baseline|Experiment 2: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301829|NCT03050801|BG004|Baseline|Experiment 2: Vertex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Vertex, over 3 days"
11301830|NCT03050801|BG005|Baseline|Experiment 2: Prefrontal rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Prefrontal Cortex over 3 days"
11301831|NCT03050801|BG006|Baseline|Total|Total of all reporting groups
11301832|NCT03050801|FG000|Participant Flow|Experiment 1: Parietal Cortex rTMS Stimulation - 1 Day|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 1 day"
11301833|NCT03050801|FG001|Participant Flow|Experiment 1: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301834|NCT03050801|FG002|Participant Flow|Experiment 1: Parietal Cortex rTMS Stimulation - 4 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 4 days"
11301835|NCT03050801|FG003|Participant Flow|Experiment 2: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301836|NCT03050801|FG004|Participant Flow|Experiment 2: Vertex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Vertex, over 3 days"
11301837|NCT03050801|FG005|Participant Flow|Experiment 2: Prefrontal Cortex Stimulation|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Prefrontal Cortex, over 3 days"
11301838|NCT03050801|OG000|Outcome|Experiment 1: Parietal Cortex rTMS Stimulation - 1 Day|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 1 day"
11301839|NCT03050801|OG001|Outcome|Experiment 1: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301840|NCT03050801|OG002|Outcome|Experiment 1: Parietal Cortex rTMS Stimulation - 4 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 4 days"
11301841|NCT03050801|OG003|Outcome|Experiment 2: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301842|NCT03050801|OG004|Outcome|Experiment 2: Vertex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Vertex, over 3 days"
11301843|NCT03050801|OG005|Outcome|Experiment 2: Prefrontal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Prefrontal Cortex, over 3 days"
11301844|NCT03050801|OG000|Outcome|Experiment 2: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301845|NCT03050801|OG001|Outcome|Experiment 2: Vertex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Vertex, over 3 days"
11301846|NCT03050801|OG002|Outcome|Experiment 2: Prefrontal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Prefrontal Cortex, over 3 days"
11301847|NCT03050801|EG000|Reported Event|Experiment 1: Parietal Cortex rTMS Stimulation - 1 Day|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 1 day"
11301848|NCT03050801|EG001|Reported Event|Experiment 1: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301849|NCT03050801|EG002|Reported Event|Experiment 1: Parietal Cortex rTMS Stimulation - 4 Days|"Experiment 1~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 4 days"
11301850|NCT03050801|EG003|Reported Event|Experiment 2: Parietal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Parietal Cortex over 3 days"
11301851|NCT03050801|EG004|Reported Event|Experiment 2: Vertex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Vertex, over 3 days"
11301852|NCT03050801|EG005|Reported Event|Experiment 2: Prefrontal Cortex rTMS Stimulation - 3 Days|"Experiment 2~rTMS: Altering the connectivity of trans-synaptic pathways with rTMS applied to the Prefrontal Cortex, over 3 days"
11301853|NCT03050918|BG000|Baseline|Phone Call Group (Intervention Arm)|Follow-up Phone Call Program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.
11301854|NCT03050918|BG001|Baseline|Usual Care Group (Control Arm)|Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.
11301855|NCT03050918|BG002|Baseline|Total|Total of all reporting groups
11301856|NCT03050918|FG000|Participant Flow|Phone Call Group (Intervention Arm)|Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.
11301857|NCT03050918|FG001|Participant Flow|Usual Care Group (Control Arm)|Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.
11301858|NCT03050918|OG000|Outcome|Phone Call Group (Intervention Arm)|Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.
11301859|NCT03050918|OG001|Outcome|Usual Care Group (Control Arm)|Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.
11301860|NCT03050918|EG000|Reported Event|Phone Call Group (Intervention Arm)|Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.
11301861|NCT03050918|EG001|Reported Event|Usual Care Group (Control Arm)|Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.
11301862|NCT03051100|BG000|Baseline|Placebo|Participants received matching oral placebo once a day.
11301863|NCT03051100|BG001|Baseline|Triplet Therapy|Participants received bempedoic acid 180 milligrams (mg), ezetimibe 10 mg, and atorvastatin 20 mg orally once a day.
11301864|NCT03051100|BG002|Baseline|Total|Total of all reporting groups
11301865|NCT03051100|FG000|Participant Flow|Placebo|Participants received matching oral placebo once a day.
11301866|NCT03051100|FG001|Participant Flow|Triplet Therapy|Participants received bempedoic acid 180 milligrams (mg), ezetimibe 10 mg, and atorvastatin 20 mg orally once a day.
11301867|NCT03051100|OG000|Outcome|Placebo|Participants received matching oral placebo once a day.
11301868|NCT03051100|OG001|Outcome|Triplet Therapy|Participants received bempedoic acid 180 milligrams (mg), ezetimibe 10 mg, and atorvastatin 20 mg orally once a day.
11301869|NCT03051100|EG000|Reported Event|Placebo|Participants received matching oral placebo once a day.
11301870|NCT03051100|EG001|Reported Event|Triplet Therapy|Participants received bempedoic acid 180 milligrams (mg), ezetimibe 10 mg, and atorvastatin 20 mg orally once a day.
11301871|NCT03051165|BG000|Baseline|Hypoglossal Nerve Stimulation Treatment Withdrawal|Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
11301872|NCT03051165|FG000|Participant Flow|Hypoglossal Nerve Stimulation Treatment Withdrawal|Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
11301873|NCT03051165|OG000|Outcome|Hypoglossal Nerve Stimulation Treatment Withdrawal|Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
11301874|NCT03051165|EG000|Reported Event|Hypoglossal Nerve Stimulation Treatment Withdrawal|Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
11301875|NCT03051256|BG000|Baseline|REL-1017 25 mg|"Loading dose of REL-1017 75 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 25 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301876|NCT03051256|BG001|Baseline|REL-1017 50 mg|"Loading dose of REL-1017 100 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 50 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301877|NCT03051256|BG002|Baseline|Placebo|"100 mL cranberry juice was administered as a single oral dose daily for 7 days.~Placebo: Placebo was administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301878|NCT03051256|BG003|Baseline|Total|Total of all reporting groups
11301879|NCT03051256|FG000|Participant Flow|REL-1017 25 mg|"Loading dose of REL-1017 75 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 25 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301880|NCT03051256|FG001|Participant Flow|REL-1017 50 mg|"Loading dose of REL-1017 100 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 50 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301881|NCT03051256|FG002|Participant Flow|Placebo|"100 mL cranberry juice was administered as a single oral dose daily for 7 days.~Placebo: Placebo was administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301882|NCT03051256|OG000|Outcome|REL-1017 25 mg|"Loading dose of REL-1017 75 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 25 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301883|NCT03051256|OG001|Outcome|REL-1017 50 mg|"Loading dose of REL-1017 100 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 50 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301884|NCT03051256|OG002|Outcome|Placebo|"100 mL cranberry juice was administered as a single oral dose daily for 7 days.~Placebo: Placebo was administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301885|NCT03051256|OG002|Outcome|Placebo|"100 mL cranberry juice was administered as a single oral dose daily for 7 days.~Placebo: Placebo will be administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301886|NCT03051256|EG000|Reported Event|REL-1017 25 mg|"Loading dose of REL-1017 75 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 25 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301887|NCT03051256|EG001|Reported Event|REL-1017 50 mg|"Loading dose of REL-1017 100 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 50 mg of powder in 100 mL cranberry juice daily on Days 2-7.~REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301888|NCT03051256|EG002|Reported Event|Placebo|"100 mL cranberry juice was administered as a single oral dose daily for 7 days.~Placebo: Placebo will be administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication."
11301889|NCT03051607|BG000|Baseline|Tozadenant|"120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.~Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted."
11301890|NCT03051607|FG000|Participant Flow|Tozadenant|"120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.~Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted."
11301891|NCT03051607|OG000|Outcome|Tozadenant|"120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.~Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted."
11301892|NCT03051607|EG000|Reported Event|Tozadenant|"120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.~Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted."
11332901|NCT03503188|FG001|Participant Flow|Non-IPF Group|All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
11332902|NCT03503188|OG000|Outcome|IPF Group|All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
11332903|NCT03503188|OG001|Outcome|Non-IPF Group|All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
11332904|NCT03503188|EG000|Reported Event|IPF Group|All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
11332905|NCT03503188|EG001|Reported Event|Non-IPF Group|All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
11332906|NCT03503292|BG000|Baseline|CYP2D6 Rapid Metabolizer (Granisetron)|"Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment~Granisetron: Rapid metabolizer received 1mg IV Granisetron"
11332907|NCT03503292|BG001|Baseline|CYP2D6 Normal Metabolizer (Ondansetron)|"Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment~Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV"
11332908|NCT03503292|BG002|Baseline|Total|Total of all reporting groups
11332909|NCT03503292|FG000|Participant Flow|CYP2D6 Rapid Metabolizer (Granisetron)|"Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment~Granisetron: Rapid metabolizer received 1mg IV Granisetron"
11332910|NCT03503292|FG001|Participant Flow|CYP2D6 Normal Metabolizer (Ondansetron)|"Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment~Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV"
11332911|NCT03503292|OG000|Outcome|CYP2D6 Rapid Metabolizer (Granisetron)|"Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment~Granisetron: Rapid metabolizer received 1mg IV Granisetron"
11301893|NCT03051620|BG000|Baseline|Study Population|Postmenopausal women and men
11301894|NCT03051620|FG000|Participant Flow|Study Population|"Postmenopausal women (postmenopausal for at least 2 years) and men above 50 years, who had been treated with alendronate for at least five years and had a total hip bone mineral density (BMD) T-score > -2.5 and lumbar spine BMD (L1-L4) T-score > -4.~We excluded patients with any low-energy fracture within the previous 5 years during alendronate treatment (not including fingers, toes, or skull), low-energy vertebral fracture or hip fracture at any time, on-going treatment with systemic glucocorticoids, metabolic bone disease, hormone replacement therapy, cancer and other conditions affecting bone metabolism."
11301895|NCT03051620|OG000|Outcome|Study Population|Study population
11301896|NCT03051620|EG000|Reported Event|Study Population|"Postmenopausal women (postmenopausal for at least 2 years) and men above 50 years, who had been treated with ALN for at least five years and had a THBMD T-score > -2.5 and LSBMD (L1-L4) T-score > -4.~We excluded patients with any low-energy fracture within the previous 5 years during ALN treatment (not including fingers, toes, or skull), low-energy VFx or hip fracture at any time, on-going treatment with systemic glucocorticoids, metabolic bone disease, hormone replacement therapy, cancer and other conditions affecting bone metabolism."
11301897|NCT03051633|BG000|Baseline|Be Under Your Own Influence Intervention|"School-based anti-substance use communications campaign~Be Under Your Own Influence: School based anti-drug use communications campaign"
11301898|NCT03051633|BG001|Baseline|Control|Assessment only
11301899|NCT03051633|BG002|Baseline|Total|Total of all reporting groups
11301900|NCT03051633|FG000|Participant Flow|Be Under Your Own Influence Intervention|"School-based anti-substance use communications campaign~Be Under Your Own Influence: School based anti-drug use communications campaign"
11301901|NCT03051633|FG001|Participant Flow|Control|Assessment only
11301902|NCT03051633|OG000|Outcome|Be Under Your Own Influence Intervention|"School-based anti-substance use communications campaign~Be Under Your Own Influence: School based anti-drug use communications campaign"
11301903|NCT03051633|OG001|Outcome|Control|Assessment only
11301904|NCT03051633|EG000|Reported Event|Be Under Your Own Influence Intervention|"School-based anti-substance use communications campaign~Be Under Your Own Influence: School based anti-drug use communications campaign"
11301905|NCT03051633|EG001|Reported Event|Control|Assessment only
11301906|NCT03051646|BG000|Baseline|Acetylsalicylic Acid at 1st Visit, Then Placebo at 2nd Visit|"Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301907|NCT03051646|BG001|Baseline|Placebo at 1st Visit, Then Acetylsalicylic Acid at 2nd Visit|"Participant is administered placebo one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301908|NCT03051646|BG002|Baseline|Total|Total of all reporting groups
11301909|NCT03051646|FG000|Participant Flow|Acetylsalicylic Acid at 1st Visit Then Placebo at 2nd Visit|"Within-subjects design~Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise~First intervention: 1 day; washout period: 1 week; second intervention: 1 day"
11301910|NCT03051646|FG001|Participant Flow|Placebo at 1st Visit Then Acetylsalicylic Acid at 2nd Visit|"Within-subjects design~Participant is administered placebo one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise~First intervention: 1 day; washout period: 1 week; second intervention: 1 day"
11301911|NCT03051646|OG000|Outcome|Acetylsalicylic Acid|"Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301912|NCT03051646|OG001|Outcome|Placebo Oral Capsule|"Participant is administered placebo one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301913|NCT03051646|OG000|Outcome|Acetylsalicylic Acid|650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise
11301914|NCT03051646|OG001|Outcome|Placebo Oral Capsule|Placebo capsule is administered one hour prior to exercise
11301915|NCT03051646|EG000|Reported Event|Acetylsalicylic Acid|"Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301916|NCT03051646|EG001|Reported Event|Placebo Oral Capsule|"Participant is administered placebo one hour prior to exercise.~Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise~Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise"
11301917|NCT03051672|BG000|Baseline|Pembrolizumab With Radiation|"Pembrolizumab will be administered intravenously prior to radiation~Pembrolizumab will be administered every 21 days~Palliative radiotherapy will be given for 5 treatments"
11301918|NCT03051672|FG000|Participant Flow|Pembrolizumab With Radiation|"Pembrolizumab will be administered intravenously prior to radiation pembrolizumab : 200 mg intravenously 2 to 7 days prior to radiotherapy (RT) and on day 1 of repeating 21-day cycles.~Palliative radiation: a total dose of 20 Gy in 5 fractions"
11301919|NCT03051672|OG000|Outcome|Pembrolizumab With Radiation|"Pembrolizumab will be administered intravenously prior to radiation~Pembrolizumab will be administered every 21 days~Palliative radiotherapy will be given for 5 treatments"
11301920|NCT03051672|OG000|Outcome|Pembrolizumab With Radiation|"pembrolizumab : 200 mg intravenously 2 to 7 days prior to radiotherapy (RT) and on day 1 of repeating 21-day cycles.~Palliative radiation: a total dose of 20 Gy in 5 fractions~Pembrolizumab: Pembrolizumab (formerly MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD1 and its ligands, PD-L1 and PD-L2.~Palliative radiotherapy: Palliative radiotherapy aims to shrink cancer, slow down its growth or control symptoms."
11301921|NCT03051672|EG000|Reported Event|Pembrolizumab With Radiation|"Pembrolizumab will be administered intravenously prior to radiation pembrolizumab : 200 mg intravenously 2 to 7 days prior to radiotherapy (RT) and on day 1 of repeating 21-day cycles.~Palliative radiation: a total dose of 20 Gy in 5 fractions"
11301922|NCT03052257|BG000|Baseline|Intervention|"Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES). Participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated."
11301923|NCT03052257|BG001|Baseline|Control|"Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened."
11301924|NCT03052257|BG002|Baseline|Total|Total of all reporting groups
11301925|NCT03052257|FG000|Participant Flow|Intervention|"Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES). Participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated."
11301926|NCT03052257|FG001|Participant Flow|Control|"Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened."
11301927|NCT03052257|OG000|Outcome|Intervention|"Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES). Participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated."
11301928|NCT03052257|OG001|Outcome|Control|"Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened."
11301929|NCT03052257|EG000|Reported Event|Intervention|"Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES). Participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated."
11301930|NCT03052257|EG001|Reported Event|Control|"Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened."
11301931|NCT03052322|BG000|Baseline|MSB11022|Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
11301932|NCT03052322|BG001|Baseline|EU-Humira|Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
11301933|NCT03052322|BG002|Baseline|Total|Total of all reporting groups
11301934|NCT03052322|FG000|Participant Flow|MSB11022|Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
11301935|NCT03052322|FG001|Participant Flow|EU-Humira|Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
11217612|NCT02314780|BG000|Baseline|Heme Arginate (High Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 3 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217613|NCT02314780|BG001|Baseline|Heme Arginate (Low Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 1 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217614|NCT02314780|BG002|Baseline|Placebo|24 hours prior to the planned surgical aortic valve replacement, subjects received a single intravenous infusion of an equivalent volume of 0.9% sodium chloride solution.
11217615|NCT02314780|BG003|Baseline|Total|Total of all reporting groups
11217616|NCT02314780|FG000|Participant Flow|Heme Arginate (High Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 3 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217617|NCT02314780|FG001|Participant Flow|Heme Arginate (Low Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 1 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217618|NCT02314780|FG002|Participant Flow|Placebo|24 hours prior to the planned surgical aortic valve replacement, subjects received a single intravenous infusion of an equivalent volume of 0.9% sodium chloride solution.
11217619|NCT02314780|OG000|Outcome|Heme Arginate (High Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 3 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217620|NCT02314780|OG001|Outcome|Heme Arginate (Low Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 1 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217621|NCT02314780|OG002|Outcome|Placebo|24 hours prior to the planned surgical aortic valve replacement, subjects received a single intravenous infusion of an equivalent volume of 0.9% sodium chloride solution.
11217622|NCT02314780|EG000|Reported Event|Heme Arginate (High Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 3 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217623|NCT02314780|EG001|Reported Event|Heme Arginate (Low Dose)|24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 1 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
11217624|NCT02314780|EG002|Reported Event|Placebo|24 hours prior to the planned surgical aortic valve replacement, subjects received a single intravenous infusion of an equivalent volume of 0.9% sodium chloride solution.
11217625|NCT02314936|BG000|Baseline|Litesse Powder Containing 12 g Polydextrose|"12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 12 g polydextrose: 12 g polydextrose"
11217626|NCT02314936|BG001|Baseline|Litesse Powder Containing 8 g Polydextrose|"8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin"
11217627|NCT02314936|BG002|Baseline|Litesse Powder Containing 4 g Polydextrose|"4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin"
11217628|NCT02314936|BG003|Baseline|Placebo|"Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Placebo: 12 g Maltodextrin"
11217629|NCT02314936|BG004|Baseline|Total|Total of all reporting groups
11217630|NCT02314936|FG000|Participant Flow|Litesse Powder Containing 12 g Polydextrose|"12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 12 g polydextrose: 12 g polydextrose"
11217631|NCT02314936|FG001|Participant Flow|Litesse Powder Containing 8 g Polydextrose|"8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin"
11217632|NCT02314936|FG002|Participant Flow|Litesse Powder Containing 4 g Polydextrose|"4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin"
11217633|NCT02314936|FG003|Participant Flow|Placebo|"Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Placebo: 12 g Maltodextrin"
11217634|NCT02314936|OG000|Outcome|Litesse Powder Containing 12 g Polydextrose|"12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 12 g polydextrose: 12 g polydextrose"
11217635|NCT02314936|OG001|Outcome|Litesse Powder Containing 8 g Polydextrose|"8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin"
11217636|NCT02314936|OG002|Outcome|Litesse Powder Containing 4 g Polydextrose|"4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin"
11217637|NCT02314936|OG003|Outcome|Placebo|"Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Placebo: 12 g Maltodextrin"
11217638|NCT02314936|EG000|Reported Event|Litesse Powder Containing 12 g Polydextrose|"12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 12 g polydextrose: 12 g polydextrose"
11217639|NCT02314936|EG001|Reported Event|Litesse Powder Containing 8 g Polydextrose|"8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin"
11217640|NCT02314936|EG002|Reported Event|Litesse Powder Containing 4 g Polydextrose|"4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin"
11301936|NCT03052322|OG000|Outcome|MSB11022|Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
11301937|NCT03052322|OG001|Outcome|EU-Humira|Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
11301938|NCT03052322|EG000|Reported Event|MSB11022|Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
11301939|NCT03052322|EG001|Reported Event|EU-Humira|Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
11301940|NCT03052426|BG000|Baseline|30 Minute Group|"roup members will be required to alternate periods of sitting and standing every 30 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301941|NCT03052426|BG001|Baseline|60 Minute Group|"roup members will be required to alternate periods of sitting and standing every 60 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301942|NCT03052426|BG002|Baseline|90 Minute Group|"roup members will be required to alternate periods of sitting and standing every 90 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301943|NCT03052426|BG003|Baseline|Total|Total of all reporting groups
11301944|NCT03052426|FG000|Participant Flow|30 Minute Group|"This group will be required to alternate periods of sitting and standing every 30 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301945|NCT03052426|FG001|Participant Flow|60 Minute Group|"This group will be required to alternate periods of sitting and standing every 60 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301946|NCT03052426|FG002|Participant Flow|90 Minute Group|"This group will be required to alternate periods of sitting and standing every 90 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301947|NCT03052426|OG000|Outcome|30 Minute Group|"This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 30 minutes throughout their workday.~Ergotron WorkFit - TL: A sit to stand work station."
11301948|NCT03052426|OG001|Outcome|60 Minute Group|"This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 60 minutes throughout their workday.~Ergotron WorkFit - TL: A sit to stand work station."
11301949|NCT03052426|OG002|Outcome|90 Minute Group|"This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 90 minutes throughout their workday.~Ergotron WorkFit - TL: A sit to stand work station."
11301950|NCT03052426|OG000|Outcome|30 Minute Group|"This group will be required to alternate periods of sitting and standing every 30 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301951|NCT03052426|OG001|Outcome|60 Minute Group|"This group will be required to alternate periods of sitting and standing every 60 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301952|NCT03052426|OG002|Outcome|90 Minute Group|"This group will be required to alternate periods of sitting and standing every 90 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301953|NCT03052426|OG000|Outcome|3 Months Results All Groups|"Groups will be required to alternate periods of sitting and standing every 30, 60, or 90 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301954|NCT03052426|OG001|Outcome|6 Months Results All Groups|Group members will be required to alternate periods of sitting and standing every 30, 60, or 90 minutes utilizing their sit-stand workstation.
11301955|NCT03052426|EG000|Reported Event|30 Minute Group|"Group members will be required to alternate periods of sitting and standing every 30 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301956|NCT03052426|EG001|Reported Event|60 Minute Group|"Group members will be required to alternate periods of sitting and standing every 60 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301957|NCT03052426|EG002|Reported Event|90 Minute Group|"Group members will be required to alternate periods of sitting and standing every 90 minutes throughout their workday using the sit to stand workstation.~Ergotron WorkFit - TL: A sit to stand work station."
11301958|NCT03052517|BG000|Baseline|QAW039 150mg|QAW039 Dose 1 once daily
11301959|NCT03052517|BG001|Baseline|QAW039 450 mg|QAW039 Dose 2 once daily
11301960|NCT03052517|BG002|Baseline|Placebo|Placebo once daily
11301961|NCT03052517|BG003|Baseline|Total|Total of all reporting groups
11301962|NCT03052517|FG000|Participant Flow|QAW039 150mg|QAW039 Dose 1 once daily
11301963|NCT03052517|FG001|Participant Flow|QAW039 450 mg|QAW039 Dose 2 once daily
11301964|NCT03052517|FG002|Participant Flow|Placebo|Placebo once daily
11301965|NCT03052517|OG000|Outcome|QAW039 150mg|QAW039 Dose 1 once daily
11301966|NCT03052517|OG001|Outcome|QAW039 450 mg|QAW039 Dose 2 once daily
11301967|NCT03052517|OG002|Outcome|Placebo|Placebo once daily
11301968|NCT03052517|EG000|Reported Event|QAW039 150 mg|QAW039 150 mg
11301969|NCT03052517|EG001|Reported Event|QAW039 450 mg|QAW039 450 mg
11301970|NCT03052517|EG002|Reported Event|Placebo|Placebo
11301971|NCT03052530|BG000|Baseline|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
11301972|NCT03052530|FG000|Participant Flow|Sapphire II PRO|"Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters~Sapphire II PRO: To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters."
11301973|NCT03052530|OG000|Outcome|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
11301974|NCT03052530|EG000|Reported Event|Sapphire II PRO|Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
11301975|NCT03052725|BG000|Baseline|Reslizumab 110 mg; Previous Treatment Placebo|Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301976|NCT03052725|BG001|Baseline|Reslizumab 110 mg: Previous Treatment Reslizumab|Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301977|NCT03052725|BG002|Baseline|Total|Total of all reporting groups
11301978|NCT03052725|FG000|Participant Flow|Reslizumab 110 mg; Previous Treatment Placebo|Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301979|NCT03052725|FG001|Participant Flow|Reslizumab 110 mg: Previous Treatment Reslizumab|Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301980|NCT03052725|OG000|Outcome|Reslizumab 110 mg; Previous Treatment Placebo|Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301981|NCT03052725|OG001|Outcome|Reslizumab 110 mg; Previous Treatment Reslizumab|Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301982|NCT03052725|EG000|Reported Event|Reslizumab 110 mg|Participants were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
11301983|NCT03052751|BG000|Baseline|Placebo|Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
11301984|NCT03052751|BG001|Baseline|UCB7665 (7 mg/kg)|Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
11301985|NCT03052751|BG002|Baseline|Total Title|
11301986|NCT03052751|FG000|Participant Flow|Placebo|Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
11301987|NCT03052751|FG001|Participant Flow|UCB7665 (7 mg/kg)|Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
11301988|NCT03052751|FG002|Participant Flow|Placebo - UCB7665 (7 mg/kg)|Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
11301989|NCT03052751|FG003|Participant Flow|Placebo - UCB7665 (4 mg/kg)|Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
11301990|NCT03052751|FG004|Participant Flow|UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg)|Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2.
11301991|NCT03052751|FG005|Participant Flow|UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg)|Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
11301992|NCT03052751|OG000|Outcome|Placebo (FAS)|Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
11301993|NCT03052751|OG001|Outcome|UCB7665 (7 mg/kg) (FAS)|Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
11301994|NCT03052751|EG000|Reported Event|Placebo (SS)|Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
11301995|NCT03052751|EG001|Reported Event|UCB7665 (7 mg/kg) (SS)|Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP).
11301996|NCT03052751|EG002|Reported Event|Placebo - UCB7665 (7 mg/kg) (SS)|Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
11301997|NCT03052751|EG003|Reported Event|Placebo - UCB7665 (4 mg/kg) (SS)|Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
11301998|NCT03052751|EG004|Reported Event|UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS)|Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
11301999|NCT03052751|EG005|Reported Event|UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)|Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
11302000|NCT03052764|BG000|Baseline|BOTOX® 100 U/BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302001|NCT03052764|BG001|Baseline|Placebo/BOTOX® 100 U|Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302002|NCT03052764|BG002|Baseline|Total|Total of all reporting groups
11302003|NCT03052764|FG000|Participant Flow|BOTOX® 100 U/BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302004|NCT03052764|FG001|Participant Flow|Placebo/BOTOX® 100 U|Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302005|NCT03052764|OG000|Outcome|BOTOX® 100 U/BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302006|NCT03052764|OG001|Outcome|Placebo/BOTOX® 100 U|Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period.
11302007|NCT03052764|EG000|Reported Event|Double Blind: BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period.
11302008|NCT03052764|EG001|Reported Event|Double Blind: Placebo|Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period.
11302009|NCT03052764|EG002|Reported Event|Open Label: BOTOX® 100 U/BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder in the Open-Label Re-Treatment Period in participants who previously received BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1.
11302010|NCT03052764|EG003|Reported Event|Open Label: Placebo/BOTOX® 100 U|BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder in the Open-Label Re-Treatment Period in participants who previously received Placebo (saline) injection into the bladder on Day 1.
11302011|NCT03052816|BG000|Baseline|ICE T|"• At the end of surgery patients receive 30mg of IV ketorolac.~Once out of PACU patients receive:~ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge~Ketorolac 30mg IV Q6h ATC until discharge~Acetaminophen 1g PO Q6h ATC until discharge~Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain~Patients are discharged home with:~Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60~Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16"
11302012|NCT03052816|BG001|Baseline|STANDARD|"• At the end of surgery patients receive 30mg of IV ketorolac.~Once out of PACU patients receive:~Ibuprofen 600mg PO Q4h PRN pain 1-3~Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6~Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10~Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain~Patients are discharged home with:~Ibuprofen 600mg PO Q8h PRN pain 1-5 #60~Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16"
11302013|NCT03052816|BG002|Baseline|Total|Total of all reporting groups
11302014|NCT03052816|FG000|Participant Flow|ICE T Postoperative Pain Regimen|"ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.~6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.~Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with PO Tylenol and PO toradol PRN.~Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough"
11302015|NCT03052816|FG001|Participant Flow|Standard Postoperative Pain Regimen|"Motrin 600mg PO Q4h PRN pain 1-3~Percocet 1 tab PO Q4-6 hours PRN 4-6 pain~Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with Motrin and Percocet for pain PRN.~Motrin/Percocet/Dilaudid for breakthrough: Standard regimen"
11302016|NCT03052816|OG000|Outcome|ICE T|"ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.~6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.~Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with PO Tylenol and PO toradol PRN.~Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough"
11302017|NCT03052816|OG001|Outcome|Standard|"Motrin 600mg PO Q4h PRN pain 1-3~Percocet 1 tab PO Q4-6 hours PRN 4-6 pain~Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with Motrin and Percocet for pain PRN.~Motrin/Percocet/Dilaudid for breakthrough: Standard regimen"
11302018|NCT03052816|OG000|Outcome|ICE T|"• At the end of surgery patients receive 30mg of IV ketorolac.~Once out of PACU patients receive:~ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge~Ketorolac 30mg IV Q6h ATC until discharge~Acetaminophen 1g PO Q6h ATC until discharge~Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain~Patients are discharged home with:~Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60~Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16"
11332912|NCT03503292|OG001|Outcome|CYP2D6 Normal Metabolizer (Ondansetron)|"Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment~Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV"
11332913|NCT03503292|EG000|Reported Event|CYP2D6 Rapid Metabolizer (Granisetron)|"Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment~Granisetron: Rapid metabolizer received 1mg IV Granisetron"
11332914|NCT03503292|EG001|Reported Event|CYP2D6 Normal Metabolizer (Ondansetron)|"Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment~Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV"
11332915|NCT03503565|BG000|Baseline|Moderate Block Group|"maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
10971718|NCT00916578|EG000|Reported Event|Single Arm Institution, Open Label, Phase II|The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Tradition therapy does will be 50-57 Gy to the initial clinical target volume.
10971719|NCT00916617|BG000|Baseline|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
10971720|NCT00916617|BG001|Baseline|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971721|NCT00916617|BG002|Baseline|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
10971722|NCT00916617|BG003|Baseline|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971723|NCT00916617|BG004|Baseline|Total|Total of all reporting groups
10971724|NCT00916617|FG000|Participant Flow|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
10971725|NCT00916617|FG001|Participant Flow|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971726|NCT00916617|FG002|Participant Flow|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
10971727|NCT00916617|FG003|Participant Flow|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971728|NCT00916617|OG000|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
10971729|NCT00916617|OG001|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971730|NCT00916617|OG002|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
10971731|NCT00916617|OG003|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971732|NCT00916617|EG000|Reported Event|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
10971733|NCT00916617|EG001|Reported Event|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971734|NCT00916617|EG002|Reported Event|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
10971735|NCT00916617|EG003|Reported Event|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
10971736|NCT00916643|BG000|Baseline|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
11217641|NCT02314936|EG003|Reported Event|Placebo|"Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks~Placebo: 12 g Maltodextrin"
11217642|NCT02315170|BG000|Baseline|All Participants|Only subjects needing bilateral ocular injections were included in the study. The total number of participants was 50 (100 eyes). Baseline characteristics were identical in both groups. One eye received the treatment with the injection guide while the fellow eye received the treatment with a standard lid speculum.
11217643|NCT02315170|FG000|Participant Flow|Intraocular Injection Guide|"novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye~intraocular injection guide: The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection"
11217644|NCT02315170|FG001|Participant Flow|Standard Lid Speculum|"Standard wire eyelid speculum~standard lid speculum: standard wire lid speculum"
11217645|NCT02315170|OG000|Outcome|Intraocular Injection Guide|"novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye~intraocular injection guide: The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection"
11217646|NCT02315170|OG001|Outcome|Standard Lid Speculum|"Standard wire eyelid speculum~standard lid speculum: standard wire lid speculum"
11302019|NCT03052816|OG001|Outcome|STANDARD|"• At the end of surgery patients receive 30mg of IV ketorolac.~Once out of PACU patients receive:~Ibuprofen 600mg PO Q4h PRN pain 1-3~Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6~Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10~Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain~Patients are discharged home with:~Ibuprofen 600mg PO Q8h PRN pain 1-5 #60~Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16"
11302020|NCT03052816|EG000|Reported Event|ICE T|"ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.~6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.~Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with PO Tylenol and PO toradol PRN.~Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough"
11302021|NCT03052816|EG001|Reported Event|Standard|"Motrin 600mg PO Q4h PRN pain 1-3~Percocet 1 tab PO Q4-6 hours PRN 4-6 pain~Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain~Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.~Patients will be discharged home with Motrin and Percocet for pain PRN.~Motrin/Percocet/Dilaudid for breakthrough: Standard regimen"
11302022|NCT03052959|BG000|Baseline|Immediate Intervention|Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
11302023|NCT03052959|BG001|Baseline|Wait List Intervention|Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
11302024|NCT03052959|BG002|Baseline|Total|Total of all reporting groups
11302025|NCT03052959|FG000|Participant Flow|Immediate Intervention|Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
11302026|NCT03052959|FG001|Participant Flow|Wait List Intervention|Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
11302027|NCT03052959|OG000|Outcome|Immediate Intervention|Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
11302028|NCT03052959|OG001|Outcome|Wait List Intervention|Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
11302029|NCT03052959|OG001|Outcome|Wait List Intervention|Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
11302030|NCT03052959|EG000|Reported Event|Immediate Intervention|Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
11302031|NCT03052959|EG001|Reported Event|Wait List Intervention|Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
11302032|NCT03052972|BG000|Baseline|Amyloid Positive|Clinically normal amyloid positive subjects from BIOCARD study
11302033|NCT03052972|BG001|Baseline|Amyloid Negative|Clinically normal amyloid negative subjects from BIOCARD study
11302034|NCT03052972|BG002|Baseline|Total|Total of all reporting groups
11302035|NCT03052972|FG000|Participant Flow|Amyloid Positive|Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
11302036|NCT03052972|FG001|Participant Flow|Amyloid Negative|Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
11302037|NCT03052972|OG000|Outcome|Amyloid Positive|Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
11302038|NCT03052972|OG001|Outcome|Amyloid Negative|Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
11302039|NCT03052972|OG002|Outcome|Total|All subjects from BIOCARD study receiving a flortaucipir PET scan
11302040|NCT03052972|EG000|Reported Event|Amyloid Positive|Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
11302041|NCT03052972|EG001|Reported Event|Amyloid Negative|Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
11302042|NCT03053050|BG000|Baseline|SEL 18 mg|"Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks~Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302043|NCT03053050|BG001|Baseline|SEL 6 mg|"Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks~OL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302044|NCT03053050|BG002|Baseline|Placebo|"Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks~OL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302045|NCT03053050|BG003|Baseline|Total|Total of all reporting groups
11302046|NCT03053050|FG000|Participant Flow|SEL 18 mg|Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks.
11302047|NCT03053050|FG001|Participant Flow|SEL 6 mg|Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.
11302048|NCT03053050|FG002|Participant Flow|Placebo|Randomized Phase: Placebo-to-match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.
11302049|NCT03053050|FG003|Participant Flow|Open-Label SEL 18 mg|Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.
11302050|NCT03053050|OG000|Outcome|SEL 18 mg|"Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks~Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302051|NCT03053050|OG001|Outcome|SEL 6 mg|"Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks~OL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302052|NCT03053050|OG002|Outcome|Placebo|"Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks~OL Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase."
11302053|NCT03053050|EG000|Reported Event|SEL 18 mg|Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo to match SEL 6 mg tablet orally once daily for 240 weeks.
11302054|NCT03053050|EG001|Reported Event|SEL 6 mg|Randomized Phase: SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.
11302055|NCT03053050|EG002|Reported Event|Placebo|Randomized Phase: Placebo to match SEL 6 mg tablet orally once daily + placebo to match SEL 18 mg tablet orally once daily for 240 weeks.
11302056|NCT03053050|EG003|Reported Event|Open-Label SEL 18 mg|Open-Label (OL) Phase: Participants who experienced a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the randomized phase.
11302057|NCT03053063|BG000|Baseline|SEL 18 mg|"Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.~Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302058|NCT03053063|BG001|Baseline|SEL 6 mg|"Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.~Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302059|NCT03053063|BG002|Baseline|Placebo|"Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.~Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302060|NCT03053063|BG003|Baseline|Total|Total of all reporting groups
11302061|NCT03053063|FG000|Participant Flow|SEL 18 mg|Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo for up to 240 weeks.
11302062|NCT03053063|FG001|Participant Flow|SEL 6 mg|Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
10971737|NCT00916643|FG000|Participant Flow|H.E.L.P. Secura|"All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.~H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.~Flush system with normal saline;~Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;~Mix plasma with equal volume of acetate buffer containing heparin;~Precipitate LDL as a complex with heparin;~Remove LDL-heparin precipitate by continuous circulation through a filter;~Remove heparin with use of a heparin adsorber;~Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;~Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient."
10971738|NCT00916643|OG000|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
10971739|NCT00916643|EG000|Reported Event|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
10971740|NCT00916721|BG000|Baseline|Propranolol|
10971741|NCT00916721|BG001|Baseline|Placebo|
10971742|NCT00916721|BG002|Baseline|Total|Total of all reporting groups
10971743|NCT00916721|FG000|Participant Flow|Propranolol|A single oral dose of propranolol or identical placebo capsule in a double-blind fashion. Propranolol dose was 0.67 mg/kg of the short-acting formulation, rounded to the nearest 10 mg, with a minimum dose of 40 mg and a maximum dose of 80 mg
10971744|NCT00916721|FG001|Participant Flow|Placebo|A single oral dose of identical placebo capsule in a double-blind fashion
10971745|NCT00916721|OG000|Outcome|Propranolol|
10971746|NCT00916721|OG001|Outcome|Placebo|
10971747|NCT00916721|EG000|Reported Event|Propranolol|
10971748|NCT00916721|EG001|Reported Event|Placebo|
10971749|NCT00916929|BG000|Baseline|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
10971750|NCT00916929|BG001|Baseline|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
10971751|NCT00916929|BG002|Baseline|Total|Total of all reporting groups
10971752|NCT00916929|FG000|Participant Flow|Implantable Cardioverter Defibrillator (ICD) Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
10971753|NCT00916929|FG001|Participant Flow|Cardiac Resynchronization Therapy (CRT-D) Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
10971754|NCT00916929|OG000|Outcome|Cardiac Resynchronization Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
10971755|NCT00916929|OG001|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
10971756|NCT00916929|OG000|Outcome|Cardiac Resynchronizaiton Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
10971757|NCT00916929|OG001|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
10971758|NCT00916929|EG000|Reported Event|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
10971759|NCT00916929|EG001|Reported Event|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
11302063|NCT03053063|FG002|Participant Flow|Placebo|Randomized Phase: Placebo to match SEL 18 mg and 6 mg tablets orally once daily for up to 240 weeks.
11302064|NCT03053063|FG003|Participant Flow|Open-Label SEL 18 mg|Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks, including the treatment duration in the randomized phase.
11302065|NCT03053063|OG000|Outcome|SEL 18 mg|"Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.~Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302066|NCT03053063|OG001|Outcome|SEL 6 mg|"Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.~Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302067|NCT03053063|OG002|Outcome|Placebo|"Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.~Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks."
11302068|NCT03053063|EG000|Reported Event|SEL 18 mg|Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
11302069|NCT03053063|EG001|Reported Event|SEL 6 mg|Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
11302070|NCT03053063|EG002|Reported Event|Placebo|Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
11302071|NCT03053063|EG003|Reported Event|Open-Label SEL 18 mg|Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
11302072|NCT03053180|BG000|Baseline|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir|Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
11302073|NCT03053180|FG000|Participant Flow|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir|"Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3 direct-acting antiviral agent [3DAA] ABBVIE REGIMEN) for 12 weeks.~The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study."
11302074|NCT03053180|OG000|Outcome|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir|Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
11302075|NCT03053180|EG000|Reported Event|Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir|Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks.
11302076|NCT03053271|BG000|Baseline|ATR-101 (Nevanimibe HCl)|Subjects received nevanimibe orally 250 mg BID for 2 weeks, then 500 mg BID for 2 weeks, then 1000 mg BID for 2-4 weeks.
11302077|NCT03053271|FG000|Participant Flow|ATR-101 (Nevanimibe HCl)|Subjects received nevanimibe orally 250 mg BID for 2 weeks, then 500 mg BID for 2 weeks, then 1000 mg BID for 2-4 weeks.
11302078|NCT03053271|OG000|Outcome|ATR-101 (Nevanimibe HCl)|Subjects received nevanimibe orally 250 mg BID for 2 weeks, then 500 mg BID for 2 weeks, then 1000 mg BID for 2-4 weeks.
11302079|NCT03053271|EG000|Reported Event|ATR-101 (Nevanimibe HCl)|Subjects received nevanimibe orally 250 mg BID for 2 weeks, then 500 mg BID for 2 weeks, then 1000 mg BID for 2-4 weeks.
11302080|NCT03053401|BG000|Baseline|Adductor Canal Block|Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
10971760|NCT00917124|BG000|Baseline|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
11302081|NCT03053401|BG001|Baseline|Femoral Nerve Block|"Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).~."
11302082|NCT03053401|BG002|Baseline|Total|Total of all reporting groups
11302083|NCT03053401|FG000|Participant Flow|Adductor Canal Block|Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
11302084|NCT03053401|FG001|Participant Flow|Femoral Nerve Block|Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
11332916|NCT03503565|BG001|Baseline|Deep Block Group|"maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
10971761|NCT00917124|BG001|Baseline|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
10971762|NCT00917124|BG002|Baseline|Total|Total of all reporting groups
11302085|NCT03053401|OG000|Outcome|Adductor Canal Block|"Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).~."
11302086|NCT03053401|OG001|Outcome|Femoral Nerve Block|Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
11302087|NCT03053401|OG000|Outcome|Adductor Canal Block|Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
11302088|NCT03053401|EG000|Reported Event|Adductor Canal Block|Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
11302089|NCT03053401|EG001|Reported Event|Femoral Nerve Block|Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
11302090|NCT03053427|BG000|Baseline|Placebo|Placebo was administered orally once daily after the evening meal.
11302091|NCT03053427|BG001|Baseline|Gabapentin Enacarbil|Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to < 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.
11302092|NCT03053427|BG002|Baseline|Total|Total of all reporting groups
11302093|NCT03053427|FG000|Participant Flow|Placebo|Placebo was administered orally once daily after the evening meal.
11302094|NCT03053427|FG001|Participant Flow|Gabapentin Enacarbil|Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to < 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.
11302095|NCT03053427|OG000|Outcome|Placebo|Placebo was administered orally once daily after the evening meal.
11302096|NCT03053427|OG001|Outcome|Gabapentin Enacarbil|Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to < 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.
11302097|NCT03053427|EG000|Reported Event|Placebo|Placebo was administered orally once daily after the evening meal.
11302098|NCT03053427|EG001|Reported Event|Gabapentin Enacarbil|Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to < 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.
11302099|NCT03053492|BG000|Baseline|Duck Duck Punch|"Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.~Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors."
11302100|NCT03053492|BG001|Baseline|Commercially Available Game|"Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.~Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf."
11302101|NCT03053492|BG002|Baseline|Total|Total of all reporting groups
11302102|NCT03053492|FG000|Participant Flow|Duck Duck Punch|"Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.~Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors."
11302103|NCT03053492|FG001|Participant Flow|Commercially Available Game|"Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.~Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf."
11302104|NCT03053492|OG000|Outcome|Duck Duck Punch|"Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.~Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors."
11302105|NCT03053492|OG001|Outcome|Commercially Available Game|"Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.~Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf."
11302106|NCT03053492|EG000|Reported Event|Duck Duck Punch|"Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.~Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors."
11302107|NCT03053492|EG001|Reported Event|Commercially Available Game|"Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.~Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf."
11332917|NCT03503565|BG002|Baseline|Total|Total of all reporting groups
11302108|NCT03054051|BG000|Baseline|Tumaini Mobile Phone Game|Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.
11302109|NCT03054051|BG001|Baseline|Standard of Care|Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
11302110|NCT03054051|BG002|Baseline|Total|Total of all reporting groups
11302111|NCT03054051|FG000|Participant Flow|Tumaini Mobile Phone Game|Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.
11302112|NCT03054051|FG001|Participant Flow|Standard of Care|Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
11302113|NCT03054051|OG000|Outcome|All Study Participants|Study participants who were randomized to either the intervention or control arm.
11302114|NCT03054051|OG000|Outcome|Tumaini Mobile Phone Game|Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.
11302115|NCT03054051|OG001|Outcome|Standard of Care|Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
11302116|NCT03054051|OG000|Outcome|Tumaini Mobile Phone Game|Participants randomized to this arm were invited to play the Tumaini game.
11302117|NCT03054051|EG000|Reported Event|Tumaini Mobile Phone Game|Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.
11302118|NCT03054051|EG001|Reported Event|Standard of Care|Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
11302119|NCT03054064|BG000|Baseline|All Enrolled Subjects|"All enrolled subjects will receive gait training with the Indego.~Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks."
11302120|NCT03054064|FG000|Participant Flow|All Enrolled Subjects|"All enrolled subjects will receive gait training with the Indego.~Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks."
10971763|NCT00917124|FG000|Participant Flow|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
10971764|NCT00917124|FG001|Participant Flow|INVOS|INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
10971765|NCT00917124|OG000|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
10971766|NCT00917124|OG001|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
10971767|NCT00917124|EG000|Reported Event|INVOS|INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
10971768|NCT00917124|EG001|Reported Event|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
10971769|NCT00917150|BG000|Baseline|OPC-6535 12.5 mg|Oral administration of 12.5mg OPC-6535 once daily for 24 months
10971770|NCT00917150|BG001|Baseline|OPC-6535 25 mg|Oral administration of 25mg OPC-6535 once daily for 24 months
11302121|NCT03054064|OG000|Outcome|All Enrolled Subjects|"All enrolled subjects will receive gait training with the Indego.~Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks."
11302122|NCT03054064|EG000|Reported Event|All Enrolled Subjects|"All enrolled subjects will receive gait training with the Indego.~Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks."
11302123|NCT03054077|BG000|Baseline|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
11302124|NCT03054077|BG001|Baseline|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
11302125|NCT03054077|BG002|Baseline|Total|Total of all reporting groups
11302126|NCT03054077|FG000|Participant Flow|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
11302127|NCT03054077|FG001|Participant Flow|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
11302128|NCT03054077|OG000|Outcome|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
11302129|NCT03054077|OG001|Outcome|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
11302130|NCT03054077|EG000|Reported Event|Control or Group 1|This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
11302131|NCT03054077|EG001|Reported Event|Intervention Group or Group 2|"This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.~iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit"
11302132|NCT03054103|BG000|Baseline|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
11302133|NCT03054103|BG001|Baseline|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302134|NCT03054103|BG002|Baseline|Midazolam + Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302135|NCT03054103|BG003|Baseline|Total|Total of all reporting groups
11302136|NCT03054103|FG000|Participant Flow|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
11302137|NCT03054103|FG001|Participant Flow|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
10971771|NCT00917150|BG002|Baseline|OPC-6535 50 mg|Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week)
10971772|NCT00917150|BG003|Baseline|Placebo|Oral administration of placebo once daily for 24 months
10971773|NCT00917150|BG004|Baseline|Total|Total of all reporting groups
10971774|NCT00917150|FG000|Participant Flow|OPC-6535 12.5 mg|Oral administration of 12.5mg OPC-6535 once daily for 24 months
10971775|NCT00917150|FG001|Participant Flow|OPC-6535 25 mg|Oral administration of 25mg OPC-6535 once daily for 24 months
10971776|NCT00917150|FG002|Participant Flow|OPC-6535 50 mg|Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week)
10971777|NCT00917150|FG003|Participant Flow|Placebo|Oral administration of placebo once daily for 24 months
10971778|NCT00917150|OG000|Outcome|OPC-6535 12.5 mg|Oral administration of 12.5mg OPC-6535 once daily for 24 months
10971779|NCT00917150|OG001|Outcome|OPC-6535 25 mg|Oral administration of 25mg OPC-6535 once daily for 24 months
10971780|NCT00917150|OG002|Outcome|OPC-6535 50 mg|Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week)
10971781|NCT00917150|OG003|Outcome|Placebo|Oral administration of placebo once daily for 24 months
10971782|NCT00917150|EG000|Reported Event|OPC-6535 12.5 mg|Oral administration of 12.5mg OPC-6535 once daily for 24 months
11302138|NCT03054103|FG002|Participant Flow|Midazolam + Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302139|NCT03054103|OG000|Outcome|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
11302140|NCT03054103|OG001|Outcome|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302141|NCT03054103|OG002|Outcome|Midazolam + Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302142|NCT03054103|EG000|Reported Event|Midazolam Alone|"Drug: Titrated midazolam + normal saline placebo~Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case."
11302143|NCT03054103|EG001|Reported Event|Midazolam + Ketamine 5 mg|"Drug: Ketamine 10 MG/ML: 0.5 ML~Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302144|NCT03054103|EG002|Reported Event|Midazolam + Ketamine 10 mg|"Drug: Ketamine 10 MG/ML: 1 ML~Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case."
11302145|NCT03054337|BG000|Baseline|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302146|NCT03054337|BG001|Baseline|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302147|NCT03054337|BG002|Baseline|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
10971783|NCT00917150|EG001|Reported Event|OPC-6535 25 mg|Oral administration of 25mg OPC-6535 once daily for 24 months
11302148|NCT03054337|BG003|Baseline|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302149|NCT03054337|BG004|Baseline|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302150|NCT03054337|BG005|Baseline|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302151|NCT03054337|BG006|Baseline|Total|Total of all reporting groups
11302152|NCT03054337|FG000|Participant Flow|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302153|NCT03054337|FG001|Participant Flow|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302154|NCT03054337|FG002|Participant Flow|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302155|NCT03054337|FG003|Participant Flow|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302156|NCT03054337|FG004|Participant Flow|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302157|NCT03054337|FG005|Participant Flow|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302158|NCT03054337|OG000|Outcome|Vadadustat 150|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
11302159|NCT03054337|OG001|Outcome|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
11302160|NCT03054337|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
11302161|NCT03054337|OG003|Outcome|Placebo|Participants were randomized to receive matching placebo for 6 weeks.
11302162|NCT03054337|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302163|NCT03054337|OG001|Outcome|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
10971784|NCT00917150|EG002|Reported Event|OPC-6535 50 mg|Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week)
10971785|NCT00917150|EG003|Reported Event|Placebo|Oral administration of placebo once daily for 24 months
10971786|NCT00917267|BG000|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
11302164|NCT03054337|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302165|NCT03054337|OG003|Outcome|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
10971787|NCT00917267|BG001|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
10971788|NCT00917267|BG002|Baseline|Total|Total of all reporting groups
10971789|NCT00917267|FG000|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
11302166|NCT03054337|OG004|Outcome|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302167|NCT03054337|OG005|Outcome|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302168|NCT03054337|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
11302169|NCT03054337|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302170|NCT03054337|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302171|NCT03054337|EG000|Reported Event|Primary Efficacy Period: 150 mg Vadadustat|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
11302172|NCT03054337|EG001|Reported Event|Primary Efficacy Period: 300 mg Vadadustat|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
11302173|NCT03054337|EG002|Reported Event|Primary Efficacy Period: 600 mg Vadadustat|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
11302174|NCT03054337|EG003|Reported Event|Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302175|NCT03054337|EG004|Reported Event|Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302176|NCT03054337|EG005|Reported Event|Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302177|NCT03054337|EG006|Reported Event|Dose Adjustment and Maintenance: 150 mg Vadadustat|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams per deciliter (g/dL) based on dose adjustment guidelines.
11302178|NCT03054337|EG007|Reported Event|Dose Adjustment and Maintenance: 300 mg Vadadustat|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302179|NCT03054337|EG008|Reported Event|Dose Adjustment and Maintenance: 600 mg Vadadustat|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302180|NCT03054337|EG009|Reported Event|Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302181|NCT03054337|EG010|Reported Event|Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302182|NCT03054337|EG011|Reported Event|Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302183|NCT03054350|BG000|Baseline|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302184|NCT03054350|BG001|Baseline|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302185|NCT03054350|BG002|Baseline|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302186|NCT03054350|BG003|Baseline|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302187|NCT03054350|BG004|Baseline|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302188|NCT03054350|BG005|Baseline|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302189|NCT03054350|BG006|Baseline|Total|Total of all reporting groups
11302190|NCT03054350|FG000|Participant Flow|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302191|NCT03054350|FG001|Participant Flow|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302192|NCT03054350|FG002|Participant Flow|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302193|NCT03054350|FG003|Participant Flow|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302194|NCT03054350|FG004|Participant Flow|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302195|NCT03054350|FG005|Participant Flow|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302196|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
11302197|NCT03054350|OG001|Outcome|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
11302198|NCT03054350|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
11302199|NCT03054350|OG003|Outcome|Placebo|Participants were randomized to receive matching placebo for 6 weeks.
11302200|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302201|NCT03054350|OG001|Outcome|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302202|NCT03054350|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302203|NCT03054350|OG003|Outcome|Placebo to Vadadustat 150 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302204|NCT03054350|OG004|Outcome|Placebo to Vadadustat 300 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302205|NCT03054350|OG005|Outcome|Placebo to Vadadustat 600 mg|Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302206|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet once daily QD, for 6 weeks.
10971790|NCT00917267|FG001|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
10971791|NCT00917267|OG000|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
11302207|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302208|NCT03054350|OG001|Outcome|Vadadustat 300 mg|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302209|NCT03054350|OG002|Outcome|Vadadustat 600 mg|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302210|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302211|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
11302212|NCT03054350|OG000|Outcome|Vadadustat 150 mg|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302213|NCT03054350|EG000|Reported Event|Primary Efficacy Period: 150 mg Vadadustat|Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
11302214|NCT03054350|EG001|Reported Event|Primary Efficacy Period: 300 mg Vadadustat|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
11302215|NCT03054350|EG002|Reported Event|Primary Efficacy Period: 600 mg Vadadustat|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
11302216|NCT03054350|EG003|Reported Event|Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302217|NCT03054350|EG004|Reported Event|Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302218|NCT03054350|EG005|Reported Event|Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat|Participants were randomized to receive matching placebo for 6 weeks.
11302219|NCT03054350|EG006|Reported Event|Dose Adjustment and Maintenance: 150 mg Vadadustat|Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
11302220|NCT03054350|EG007|Reported Event|Dose Adjustment and Maintenance: 300 mg Vadadustat|Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302221|NCT03054350|EG008|Reported Event|Dose Adjustment and Maintenance: 600 mg Vadadustat|Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
11302222|NCT03054350|EG009|Reported Event|Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302223|NCT03054350|EG010|Reported Event|Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302224|NCT03054350|EG011|Reported Event|Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat|"Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.~During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines."
11302225|NCT03054428|BG000|Baseline|Placebo|Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). Participants in the <60-kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) or placebo matching 300 milligram (mg). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab.
11302226|NCT03054428|BG001|Baseline|Dupilumab 300 mg Q4W|Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. To maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 millilitre (mL) injection at the weeks dupilumab was not given.
11302227|NCT03054428|BG002|Baseline|Dupilumab 200 mg or 300 mg Q2W|Participants with baseline weight <60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
11302228|NCT03054428|BG003|Baseline|Total|Total of all reporting groups
11302229|NCT03054428|FG000|Participant Flow|Placebo|Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). Participants in the <60-kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) or placebo matching 300 milligram (mg). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab.
11302230|NCT03054428|FG001|Participant Flow|Dupilumab 300 mg Q4W|Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. To maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 millilitre (mL) injection at the weeks dupilumab was not given.
11302231|NCT03054428|FG002|Participant Flow|Dupilumab 200 mg or 300 mg Q2W|Participants with baseline weight <60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
11302232|NCT03054428|OG000|Outcome|Placebo|Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). Participants in the <60-kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) or placebo matching 300 milligram (mg). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab.
11302233|NCT03054428|OG001|Outcome|Dupilumab 300 mg Q4W|Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. To maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 millilitre (mL) injection at the weeks dupilumab was not given.
11302234|NCT03054428|OG002|Outcome|Dupilumab 200 mg or 300 mg Q2W|Participants with baseline weight <60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
11302235|NCT03054428|EG000|Reported Event|Placebo|Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). Participants in the <60-kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) or placebo matching 300 milligram (mg). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab.
11302236|NCT03054428|EG001|Reported Event|Dupilumab 300 mg Q4W|Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. To maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 millilitre (mL) injection at the weeks dupilumab was not given.
11302237|NCT03054428|EG002|Reported Event|Dupilumab 200 mg or 300 mg|Participants with baseline weight <60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kgreceived Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
11302238|NCT03054506|BG000|Baseline|CSP01|"Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.~CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302239|NCT03054506|BG001|Baseline|Carboxymethylcellulose (CMC)|"Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.~Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302240|NCT03054506|BG002|Baseline|Placebo|"Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.~Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302241|NCT03054506|BG003|Baseline|Total|Total of all reporting groups
11302242|NCT03054506|FG000|Participant Flow|CSP01|"Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.~CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302243|NCT03054506|FG001|Participant Flow|Carboxymethylcellulose (CMC)|"Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.~Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302244|NCT03054506|FG002|Participant Flow|Placebo|"Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.~Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302245|NCT03054506|OG000|Outcome|CSP01|"Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.~CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302246|NCT03054506|OG001|Outcome|Carboxymethylcellulose (CMC)|"Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.~Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302247|NCT03054506|OG002|Outcome|Placebo|"Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.~Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302248|NCT03054506|EG000|Reported Event|CSP01|"Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief.~CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
10971792|NCT00917267|OG001|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
11302249|NCT03054506|EG001|Reported Event|Carboxymethylcellulose (CMC)|"Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.~Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302250|NCT03054506|EG002|Reported Event|Placebo|"Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day.~Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks."
11302251|NCT03054649|BG000|Baseline|HMIOL|Implantation with HMIOL system
11302252|NCT03054649|FG000|Participant Flow|Cohort 1|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
10971793|NCT00917267|OG000|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
11302253|NCT03054649|FG001|Participant Flow|Cohort 2|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302254|NCT03054649|OG000|Outcome|Cohort 1|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302255|NCT03054649|OG001|Outcome|Cohort 2|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic)
11302256|NCT03054649|OG001|Outcome|Cohort 2|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302257|NCT03054649|OG000|Outcome|Cohort 1 - Day 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302258|NCT03054649|OG001|Outcome|Cohort 1 - Week 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302259|NCT03054649|OG002|Outcome|Cohort 1 - Month 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302260|NCT03054649|OG003|Outcome|Cohort 1 - Month 3 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302261|NCT03054649|OG000|Outcome|Cohort 2 - Day 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302262|NCT03054649|OG001|Outcome|Cohort 2 - Week 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302263|NCT03054649|OG002|Outcome|Cohort 2 - Month 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302264|NCT03054649|OG003|Outcome|Cohort 2 - Month 3 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
10971794|NCT00917267|OG001|Outcome|Exenatide Twice Daily With SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
10971795|NCT00917267|OG002|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
11302265|NCT03054649|OG000|Outcome|Cohort 1 - Baseline (Day 0 Preoperative)|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302266|NCT03054649|OG000|Outcome|Cohort 2 - Baseline (Day 0 Preoperative)|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302267|NCT03054649|OG001|Outcome|Day 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302268|NCT03054649|OG002|Outcome|Cohort 1 - Week 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302269|NCT03054649|OG003|Outcome|Cohort 1 - Month 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302270|NCT03054649|OG004|Outcome|Cohort 1 - Month 3 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
10971796|NCT00917267|OG003|Outcome|Exenatide Twice Daily Without SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
10971797|NCT00917267|EG000|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
10971798|NCT00917267|EG001|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
10971799|NCT00917384|BG000|Baseline|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
11302271|NCT03054649|OG001|Outcome|Cohort 2 - Day 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302272|NCT03054649|OG002|Outcome|Cohort 2 - Week 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302273|NCT03054649|OG003|Outcome|Cohort 2 - Month 1 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302274|NCT03054649|OG004|Outcome|Cohort 2 - Month 3 Postoperative|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302275|NCT03054649|OG000|Outcome|Cohort 1 - Month 1 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302276|NCT03054649|OG001|Outcome|Cohort 1 - Month 3 Postoperative|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302277|NCT03054649|OG000|Outcome|Cohort 1 - No Exchange|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302278|NCT03054649|OG001|Outcome|Cohort 2 - Intraoperative Exchange|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
10971800|NCT00917384|BG001|Baseline|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
11302279|NCT03054649|EG000|Reported Event|Cohort 1|Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange
11302280|NCT03054649|EG001|Reported Event|Cohort 2|Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)
11302281|NCT03054740|BG000|Baseline|Gebauer Ethyl Chloride|"Device: Vapocoolant (Ethyl Chloride Mist Spray)~Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds."
11302282|NCT03054740|BG001|Baseline|Nature's Tears|"Device: Sterile Water~Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access"
10971801|NCT00917384|BG002|Baseline|Total|Total of all reporting groups
11302283|NCT03054740|BG002|Baseline|Total|Total of all reporting groups
11302284|NCT03054740|FG000|Participant Flow|Gebauer Ethyl Chloride|"Device: Vapocoolant (Ethyl Chloride Mist Spray)~Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds."
11302285|NCT03054740|FG001|Participant Flow|Nature's Tears|"Device: Sterile Water~Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access"
11302286|NCT03054740|OG000|Outcome|Gebauer Ethyl Chloride|"Device: Vapocoolant (Ethyl Chloride Mist Spray)~Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds."
11302287|NCT03054740|OG001|Outcome|Nature's Tears|"Device: Sterile Water~Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access"
11302288|NCT03054740|EG000|Reported Event|Gebauer Ethyl Chloride|"Drug: Vapocoolant (Ethyl Chloride Mist Spray)~Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds."
11302289|NCT03054740|EG001|Reported Event|Nature's Tears|"Drug: Sterile Water~Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access"
11302290|NCT03054805|BG000|Baseline|Magnesium Oxide and MIYAIRI-BM|"Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks.~MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg~MIYAIRI-BM: MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg"
11302291|NCT03054805|BG001|Baseline|Magnesium Oxide|"MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg"
11302292|NCT03054805|BG002|Baseline|Healthy Children|Healthy children without any treatment
11302293|NCT03054805|BG003|Baseline|Total|Total of all reporting groups
11302294|NCT03054805|FG000|Participant Flow|Magnesium Oxide and MIYAIRI-BM|"Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks.~MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg~MIYAIRI-BM: MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg"
11302295|NCT03054805|FG001|Participant Flow|Magnesium Oxide|"MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg"
11302296|NCT03054805|FG002|Participant Flow|Healthy Children|Healthy children without any treatment
11302297|NCT03054805|OG000|Outcome|Magnesium Oxide and MIYAIRI-BM|"Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks.~MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg~MIYAIRI-BM: MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg"
11302298|NCT03054805|OG001|Outcome|Magnesium Oxide|"MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg"
11302299|NCT03054805|OG002|Outcome|Healthy Children|Healthy children without any treatment
11302300|NCT03054805|EG000|Reported Event|Magnesium Oxide and MIYAIRI-BM|"Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks.~MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg~MIYAIRI-BM: MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg"
11302301|NCT03054805|EG001|Reported Event|Magnesium Oxide|"MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.~Magnesium Oxide: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg"
11302302|NCT03054805|EG002|Reported Event|Healthy Children|Healthy children without any treatment
11302303|NCT03054844|BG000|Baseline|PREMED|"Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.~Lidocaine: Lidocaine will be administered before administration of midazolam.~Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine."
11302304|NCT03054844|BG001|Baseline|PREMIX|"Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).~Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam."
11302305|NCT03054844|BG002|Baseline|Total|Total of all reporting groups
11302306|NCT03054844|FG000|Participant Flow|PREMED|"Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.~Lidocaine: Lidocaine will be administered before administration of midazolam.~Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine."
11302307|NCT03054844|FG001|Participant Flow|PREMIX|"Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).~Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam."
11302308|NCT03054844|OG000|Outcome|PREMED|"Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.~Lidocaine: Lidocaine will be administered before administration of midazolam.~Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine."
11302309|NCT03054844|OG001|Outcome|PREMIX|"Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).~Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam."
11302310|NCT03054844|EG000|Reported Event|PREMED|"Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.~Lidocaine: Lidocaine will be administered before administration of midazolam.~Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine."
11302311|NCT03054844|EG001|Reported Event|PREMIX|"Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).~Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam."
11302312|NCT03054857|BG000|Baseline|Dex Group|After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
11302313|NCT03054857|BG001|Baseline|Placebo Group|The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
11302314|NCT03054857|BG002|Baseline|Total|Total of all reporting groups
10971802|NCT00917384|FG000|Participant Flow|IMC-1121B (Ramucirumab )|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
10971803|NCT00917384|FG001|Participant Flow|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
10971804|NCT00917384|OG000|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
10971805|NCT00917384|OG001|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
10971806|NCT00917384|EG000|Reported Event|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
11302315|NCT03054857|FG000|Participant Flow|Dex Group|After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
11302316|NCT03054857|FG001|Participant Flow|Placebo Group|The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
11302317|NCT03054857|OG000|Outcome|Dex Group|After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
11302318|NCT03054857|OG001|Outcome|Placebo Group|The control group received a loading dose and continuous IV infusion of normal saline at the same rate
11302319|NCT03054857|OG000|Outcome|Dex Group|After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
11302320|NCT03054857|OG001|Outcome|Placebo Group|The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
11302321|NCT03054857|OG000|Outcome|Dex Group|"After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.~Dexmedetomidine: After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation."
11302322|NCT03054857|OG001|Outcome|Placebo Group|"The control group received a loading dose and continuous IV infusion of normal saline at the same rate.~Placebo: The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group"
11302323|NCT03054857|EG000|Reported Event|Dex Group|After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
11302324|NCT03054857|EG001|Reported Event|Placebo Group|The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
11302325|NCT03054870|BG000|Baseline|Xe-133 Followed by Technegas|Subjects received the active comparator Xe-133 followed by inhalation of experimental Technegas on the same day.
11302326|NCT03054870|FG000|Participant Flow|Xe-133 Followed by Technegas|"Subjects first inhaled active comparator Xe-133, approximately 10 to 30 millicuries (mCi), and ventilation planar scintigraphy was performed per site standard of care procedures for subject medical need. On the same day, following completion of Xe-133 imaging, subjects inhaled experimental Technegas (Technetium-99m labeled carbon particles), approximately 1.1 mCi, and ventilation planar scintigraphy was performed.~Xe-133: Xe-133 ventilation scintigraphy~Technegas: Technegas ventilation scintigraphy"
11302327|NCT03054870|OG000|Outcome|Blinded Reader 03|Blinded Reader 03's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on Matched image views.
11302328|NCT03054870|OG001|Outcome|Blinded Reader 04|Blinded Reader 04's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on Matched image views.
11302329|NCT03054870|OG002|Outcome|Blinded Reader 05|Blinded Reader 05's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on Matched image views.
11302330|NCT03054870|OG000|Outcome|Blinded Reader 03|Blinded Reader 03's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on All image views.
11302331|NCT03054870|OG001|Outcome|Blinded Reader 04|Blinded Reader 04's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on All image views.
11302332|NCT03054870|OG002|Outcome|Blinded Reader 05|Blinded Reader 05's Percent Agreement between Xe-133 and Technegas Ventilation Scores based on All image views.
11302333|NCT03054870|OG000|Outcome|Xe-133 PA|Percent agreement (PA) between a pair of blinded readers ventilation lung scores based on assessment of Xe-133 image views.
11302334|NCT03054870|OG001|Outcome|Technegas PA Matched Views|Percent agreement (PA) between a pair of blinded readers ventilation lung scores based on assessment of Technegas image views that matched the Xe-133 image views.
11302335|NCT03054870|OG002|Outcome|Technegas PA All Views|Percent agreement (PA) between a pair of blinded readers ventilation lung scores based on assessment of all Technegas image views.
11302336|NCT03054870|OG000|Outcome|Xe-133 Kappa|Kappa statistics for a pair of blinded readers ventilation lung scores based on assessment of Xe-133 image views.
11302337|NCT03054870|OG001|Outcome|Technegas Kappa Matched Views|Kappa statistics for a pair of blinded readers ventilation lung scores based on assessment of Technegas image views that matched the Xe-133 image views.
11302338|NCT03054870|OG002|Outcome|Technegas Kappa All Views|Kappa statistics for a pair of blinded readers ventilation lung scores based on assessment of all Technegas image views.
11302339|NCT03054870|EG000|Reported Event|Xe-133 Followed by Technegas|Subjects first inhaled active comparator Xe-133, approximately 10 to 30 millicuries (mCi), and ventilation planar scintigraphy was performed per site standard of care procedures for subject medical need. On the same day, following completion of Xe-133 imaging, subjects inhaled experimental Technegas (Technetium-99m labeled carbon particles), approximately 1.1 mCi, and ventilation planar scintigraphy was performed.
11302340|NCT03054922|BG000|Baseline|Normal Saline|"0.9% Sodium Chloride~Normal Saline: IV infusion of 0.9% NaCl throughout surgery."
11302341|NCT03054922|BG001|Baseline|Lactated Ringers|"Each 100 mL of Lactated Ringer's Injection USP contains:~Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs~Lactated Ringer: IV infusion of lactated ringer throughout surgery."
11302342|NCT03054922|BG002|Baseline|Normosol-R|"Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.~Normosol-R Inj: IV infusion of Normosol throughout surgery."
11302343|NCT03054922|BG003|Baseline|Total|Total of all reporting groups
11302344|NCT03054922|FG000|Participant Flow|Normal Saline|"0.9% Sodium Chloride~Normal Saline: IV infusion of 0.9% NaCl throughout surgery."
11302345|NCT03054922|FG001|Participant Flow|Lactated Ringers|"Each 100 mL of Lactated Ringer's Injection USP contains:~Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs~Lactated Ringer: IV infusion of lactated ringer throughout surgery."
11302346|NCT03054922|FG002|Participant Flow|Normosol-R|"Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.~Normosol-R Inj: IV infusion of Normosol throughout surgery."
11302347|NCT03054922|OG000|Outcome|Normal Saline|"0.9% Sodium Chloride~Normal Saline: IV infusion of 0.9% NaCl throughout surgery."
11302348|NCT03054922|OG001|Outcome|Lactated Ringers|"Each 100 mL of Lactated Ringer's Injection USP contains:~Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs~Lactated Ringer: IV infusion of lactated ringer throughout surgery."
11302349|NCT03054922|OG002|Outcome|Normosol-R|"Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.~Normosol-R Inj: IV infusion of Normosol throughout surgery."
11302350|NCT03054922|EG000|Reported Event|Normal Saline|"0.9% Sodium Chloride~Normal Saline: IV infusion of 0.9% NaCl throughout surgery."
11302351|NCT03054922|EG001|Reported Event|Lactated Ringers|"Each 100 mL of Lactated Ringer's Injection USP contains:~Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs~Lactated Ringer: IV infusion of lactated ringer throughout surgery."
11302352|NCT03054922|EG002|Reported Event|Normosol-R|"Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.~Normosol-R Inj: IV infusion of Normosol throughout surgery."
11302353|NCT03055000|BG000|Baseline|AGS-v|825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302354|NCT03055000|BG001|Baseline|AGS-v With Adjuvant|825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302355|NCT03055000|BG002|Baseline|Placebo|Placebo 2 doses given 21 days apart
11302356|NCT03055000|BG003|Baseline|Total|Total of all reporting groups
11302357|NCT03055000|FG000|Participant Flow|AGS-v|825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302358|NCT03055000|FG001|Participant Flow|AGS-v With Adjuvant|825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses givemn 21 days apart
11302359|NCT03055000|FG002|Participant Flow|Placebo|Placebo 2 doses given 21 days apart
11302360|NCT03055000|OG000|Outcome|AGS-v|825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302361|NCT03055000|OG001|Outcome|AGS-v With Adjuvant|825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302362|NCT03055000|OG002|Outcome|Placebo|Placebo 2 doses given 21 days apart
11302363|NCT03055000|EG000|Reported Event|AGS-v|825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302364|NCT03055000|EG001|Reported Event|AGS-v With Adjuvant|825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
11302365|NCT03055000|EG002|Reported Event|Placebo|Placebo 2 doses given 21 days apart
11302366|NCT03055156|BG000|Baseline|Low Rebound Mattress Toppers|Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302367|NCT03055156|BG001|Baseline|High Rebound Mattress Toppers|Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302368|NCT03055156|BG002|Baseline|Total|Total of all reporting groups
11302369|NCT03055156|FG000|Participant Flow|Low Rebound Mattress Toppers|Participants in arm 1 slept on low rebound mattress toppers (Topper Deluxe 3.5, TEMPUR-SEALY Japan Ltd., Kobe, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302370|NCT03055156|FG001|Participant Flow|High Rebound Mattress Toppers|Participants in arm 2 slept on high rebound mattress toppers (airweave® toppers, airweave inc., Tokyo, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302371|NCT03055156|OG000|Outcome|Low Rebound Mattress Toppers|Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302372|NCT03055156|OG001|Outcome|High Rebound Mattress Toppers|Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302373|NCT03055156|EG000|Reported Event|Low Rebound Mattress Toppers|Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302374|NCT03055156|EG001|Reported Event|High Rebound Mattress Toppers|Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
11302375|NCT03055195|BG000|Baseline|Placebo SC|Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302376|NCT03055195|BG001|Baseline|Mepolizumab 100 mg SC|Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302377|NCT03055195|BG002|Baseline|Total|Total of all reporting groups
11302378|NCT03055195|FG000|Participant Flow|Placebo SC|Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302379|NCT03055195|FG001|Participant Flow|Mepolizumab 100 mg SC|Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302380|NCT03055195|OG000|Outcome|Placebo SC|Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302381|NCT03055195|OG001|Outcome|Mepolizumab 100 mg SC|Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302382|NCT03055195|EG000|Reported Event|Placebo SC|Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302383|NCT03055195|EG001|Reported Event|Mepolizumab 100 mg SC|Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
11302384|NCT03055221|BG000|Baseline|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
11302385|NCT03055221|FG000|Participant Flow|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
11302386|NCT03055221|OG000|Outcome|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
11302387|NCT03055221|EG000|Reported Event|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.~Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
11302388|NCT03055260|BG000|Baseline|Blood Flow Restriction Cuff|"This group will receive an active cuff that partially restricts blood flow to the experimental limb.~Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302389|NCT03055260|BG001|Baseline|Blood Flow Restriction Cuff-Placebo|"This group will wear a placebo cuff, of which will not restrict blood flow at all.~Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302390|NCT03055260|BG002|Baseline|Total|Total of all reporting groups
11302391|NCT03055260|FG000|Participant Flow|Blood Flow Restriction Cuff|"This group will receive an active cuff that partially restricts blood flow to the experimental limb.~Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
10822261|NCT00075725|BG003|Baseline|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822262|NCT00075725|BG004|Baseline|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822263|NCT00075725|BG005|Baseline|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822264|NCT00075725|BG006|Baseline|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
11302392|NCT03055260|FG001|Participant Flow|Blood Flow Restriction Cuff-Placebo|"This group will wear a placebo cuff, of which will not restrict blood flow at all.~Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302393|NCT03055260|OG000|Outcome|Blood Flow Restriction Cuff|"This group will receive an active cuff that partially restricts blood flow to the experimental limb.~Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302394|NCT03055260|OG001|Outcome|Blood Flow Restriction Cuff-Placebo|"This group will wear a placebo cuff, of which will not restrict blood flow at all.~Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302395|NCT03055260|EG000|Reported Event|Blood Flow Restriction Cuff|"This group will receive an active cuff that partially restricts blood flow to the experimental limb.~Blood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302396|NCT03055260|EG001|Reported Event|Blood Flow Restriction Cuff-Placebo|"This group will wear a placebo cuff, of which will not restrict blood flow at all.~Blood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb."
11302397|NCT03055338|BG000|Baseline|MK-8189|Participants receive MK-8189 (4 mg CR oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) QD for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.
11302398|NCT03055338|BG001|Baseline|Risperidone|Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
11302399|NCT03055338|BG002|Baseline|Placebo|Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.
11302400|NCT03055338|BG003|Baseline|Total|Total of all reporting groups
11302401|NCT03055338|FG000|Participant Flow|MK-8189|Participants receive MK-8189 (4 mg controlled release [CR] oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) once daily (QD) for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.
11302402|NCT03055338|FG001|Participant Flow|Risperidone|Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
11302403|NCT03055338|FG002|Participant Flow|Placebo|Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.
11302404|NCT03055338|OG000|Outcome|MK-8189|Participants receive MK-8189 (4 mg CR oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) QD for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.
11302405|NCT03055338|OG001|Outcome|Risperidone|Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
11302406|NCT03055338|OG002|Outcome|Placebo|Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.
11302407|NCT03055338|EG000|Reported Event|MK-8189|Participants receive MK-8189 (4 mg CR oral tablet[s]) in combination with placebo matching risperidone (oral capsule[s]) QD for 4 weeks. Over the initial 7 treatment days, MK-8189 is titrated from 4 mg to 12 mg as follows: 4 mg (1 tablet; Day 1); 8 mg (2 tablets; Day 4); and 12 mg (3 tablets; Day 7). Placebo matching risperidone is mock titrated as follows: 1 capsule (Day 1), 2 capsules (Day 4), and 3 capsules (Day 7). After Day 7, MK-8189 is maintained at 12 mg (3 tablets) in combination with placebo matching risperidone (3 capsules), QD for 3 weeks.
11302408|NCT03055338|EG001|Reported Event|Risperidone|Participants receive risperidone (2 mg oral capsule[s]) in combination with placebo matching MK-8189 (oral tablet[s]), QD for 4 weeks. Over the initial 7 treatment days, risperidone is titrated from 2 mg to 6 mg as follows: 2 mg (1 capsule; Day 1); 4 mg (2 capsules; Day 4); and 6 mg (3 capsules; Day 7). Placebo matching MK-8189 is mock titrated as follows: 1 tablet (Day 1), 2 tablets (Day 4), and 3 tablets (Day 7). After Day 7, risperidone is maintained at 6 mg (3 capsules) in combination with placebo matching MK-8189 (3 tablets), QD for 3 weeks.
11302409|NCT03055338|EG002|Reported Event|Placebo|Participants receive both placebo matching MK-8189 (oral tablet[s]) as well as placebo matching Risperidone (oral capsule[s]), QD for 4 weeks. Over the initial 7 treatment days, placebo matching both MK-8189 and risperidone are respectively mock titrated as follows: 1 tablet/1 capsule (Day 1); 2 tablets/2 capsules (Day 4); and 3 tablets/3 capsules (Day 7). After Day 7, placebo matching both MK-8189 and risperidone are respectively maintained at 3 tablets/3 capsules, QD for 3 weeks.
11302410|NCT03055494|BG000|Baseline|Secukinumab 300 mg|Participants received secukinumab 300 mg s.c. at randomization
11302411|NCT03055494|BG001|Baseline|Placebo|Participants received placebo at randomization
11302412|NCT03055494|BG002|Baseline|Total|Total of all reporting groups
11302413|NCT03055494|FG000|Participant Flow|Secukinumab 300 mg|Participants received secukinumab 300 mg s.c. at randomization
11302414|NCT03055494|FG001|Participant Flow|Placebo/Secukinumab 300 mg|Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
11302415|NCT03055494|OG000|Outcome|Secukinumab 300 mg|Participants received secukinumab 300 mg s.c. at randomization
11302416|NCT03055494|OG001|Outcome|Placebo|Participants received placebo at randomization
11302417|NCT03055494|OG001|Outcome|Placebo/Secukinumab 300 mg|Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
11302418|NCT03055494|EG000|Reported Event|Secukinumab 300 mg|Secukinumab 300 mg
11302419|NCT03055494|EG001|Reported Event|Placebo/Secukinumab 300 mg|Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12
11302420|NCT03055624|BG000|Baseline|Prostate Artery Embolization|"Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.~Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia."
11302421|NCT03055624|FG000|Participant Flow|Prostate Artery Embolization|"Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.~Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia."
11302422|NCT03055624|OG000|Outcome|Prostate Artery Embolization|"Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.~Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia."
11302423|NCT03055624|EG000|Reported Event|Prostate Artery Embolization|"Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.~Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia."
11302424|NCT03055650|BG000|Baseline|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302425|NCT03055650|FG000|Participant Flow|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302426|NCT03055650|OG000|Outcome|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302427|NCT03055650|EG000|Reported Event|iLux 2020 System|"Meibomian Gland Treatment~iLux 2020 System: Heating and compression to express clogged meibomian glands"
11302428|NCT03055806|BG000|Baseline|Placebo|Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302429|NCT03055806|BG001|Baseline|IX-01 400 mg|400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302430|NCT03055806|BG002|Baseline|IX-01 800 mg|800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302431|NCT03055806|BG003|Baseline|IX-01 1200 mg|1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302432|NCT03055806|BG004|Baseline|Total|Total of all reporting groups
11302433|NCT03055806|FG000|Participant Flow|Placebo|Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302434|NCT03055806|FG001|Participant Flow|IX-01 400 mg|400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302435|NCT03055806|FG002|Participant Flow|IX-01 800 mg|800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302436|NCT03055806|FG003|Participant Flow|IX-01 1200 mg|1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302437|NCT03055806|OG000|Outcome|Placebo|Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302438|NCT03055806|OG001|Outcome|IX-01 400 mg|400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302439|NCT03055806|OG002|Outcome|IX-01 800 mg|800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302440|NCT03055806|OG003|Outcome|IX-01 1200 mg|1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302441|NCT03055806|EG000|Reported Event|Placebo|Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302442|NCT03055806|EG001|Reported Event|IX-01 400 mg|400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302443|NCT03055806|EG002|Reported Event|IX-01 800 mg|800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302444|NCT03055806|EG003|Reported Event|IX-01 1200 mg|1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
11302445|NCT03055832|BG000|Baseline|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302446|NCT03055832|BG001|Baseline|LipiFlow Thermal Pulsation System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302447|NCT03055832|BG002|Baseline|Total|Total of all reporting groups
11302448|NCT03055832|FG000|Participant Flow|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302449|NCT03055832|FG001|Participant Flow|LipiFlow Thermal Pulsation System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302450|NCT03055832|OG000|Outcome|iLux Right Eye|Right Eye of Subjects treated with the iLux 2020 System
11302451|NCT03055832|OG001|Outcome|iLux Left Eye|Left Eye of Subjects treated with the iLux 2020 System
11302452|NCT03055832|OG002|Outcome|iLux Both Eyes|Both Eyes of Subjects treated with the iLux 2020 System
11302453|NCT03055832|OG003|Outcome|LipiFlow Right Eye|Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
11302454|NCT03055832|OG004|Outcome|LipiFlow Left Eye|Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
11302455|NCT03055832|OG005|Outcome|LipiFlow Both Eyes|Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
11302456|NCT03055832|OG000|Outcome|iLux 2020 System|"Meibomian Gland Treatment~iLux 2020 System: Heating and compression to express clogged meibomian glands"
11302457|NCT03055832|OG001|Outcome|LipiFlow Thermal Pulsation System|"Meibomian Gland Treatment~LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands"
11302458|NCT03055832|OG000|Outcome|iLux All Questions|All OSDI questions in Subjects treated with the iLux 2020 System
11302459|NCT03055832|OG001|Outcome|iLux Vision Questions|OSDI Questions 1-5 in Subjects Treated with the iLux 2020 System
11302460|NCT03055832|OG002|Outcome|iLux Ocular Questions|OSDI questions 6-9 in Subjects treated with the iLux 2020 System
11302461|NCT03055832|OG003|Outcome|iLux Trigger Questions|OSDI questions 10-12 in Subjects treated with the iLux 2020 System
11302462|NCT03055832|OG004|Outcome|LipiFlow All Questions|All OSDI questions (1-12) in Subjects treated with the LipiFlow Thermal Pulsation System
11302463|NCT03055832|OG005|Outcome|LipiFlow Vision Questions|OSDI Questions 1-5 in Subjects treated with the LipiFlow Thermal Pulsation System
11302464|NCT03055832|OG006|Outcome|LipiFlow Ocular Questions|OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
11302465|NCT03055832|OG007|Outcome|LipiFlow Trigger Questions|OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
11302466|NCT03055832|EG000|Reported Event|iLux 2020 System|"Meibomian Gland Treatment~iLux 2020 System: Heating and compression to express clogged meibomian glands"
11302467|NCT03055832|EG001|Reported Event|LipiFlow Thermal Pulsation System|"Meibomian Gland Treatment~LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands"
11302468|NCT03055858|BG000|Baseline|PDA Closure|ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
11302469|NCT03055858|FG000|Participant Flow|PDA Closure|ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
11302470|NCT03055858|OG000|Outcome|PDA Closure|ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
11302471|NCT03055858|EG000|Reported Event|PDA Closure|ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
11302472|NCT03055897|BG000|Baseline|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302473|NCT03055897|FG000|Participant Flow|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302474|NCT03055897|OG000|Outcome|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302475|NCT03055897|EG000|Reported Event|iLux 2020 System|Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
11302476|NCT03055936|BG000|Baseline|Group 1|A1 levodopa 50 mg, carbidopa 12.5 mg; B1 levodopa 50 mg, carbidopa 65 mg; C1 levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg; D1 levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
11302477|NCT03055936|BG001|Baseline|Group 2|A2 levodopa 100 mg, carbidopa 25 mg; B2 levodopa 100 mg, carbidopa 65 mg; C2 levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg; D2 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302478|NCT03055936|BG002|Baseline|Group 3|A3 levodopa 150 mg, carbidopa 37.5 mg; B3 levodopa 150 mg, carbidopa 65 mg; C3 levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg; D3 levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
11302479|NCT03055936|BG003|Baseline|Group 4|A4 (Sinemet): levodopa IR 100 mg, carbidopa 25 mg; B4 levodopa 100 mg, carbidopa 65 mg; C4 levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302480|NCT03055936|BG004|Baseline|Total|Total of all reporting groups
11302481|NCT03055936|FG000|Participant Flow|Group 1|A1 levodopa 50 mg, carbidopa 12.5 mg; B1 levodopa 50 mg, carbidopa 65 mg; C1 levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg; D1 levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
11302482|NCT03055936|FG001|Participant Flow|Group 2|A2 levodopa 100 mg, carbidopa 25 mg; B2 levodopa 100 mg, carbidopa 65 mg; C2 levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg; D2 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302483|NCT03055936|FG002|Participant Flow|Group 3|A3 levodopa 150 mg, carbidopa 37.5 mg; B3 levodopa 150 mg, carbidopa 65 mg; C3 levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg; D3 levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
11302484|NCT03055936|FG003|Participant Flow|Group 4|A4 (Sinemet: levodopa IR 100 mg, carbidopa 25 mg; B4 levodopa 100 mg, carbidopa 65 mg; C4 levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302485|NCT03055936|OG000|Outcome|A1 50 mg LD + 12.5 mg CD|50 mg of MR levodopa + 12.5 mg of carbidopa
11302486|NCT03055936|OG001|Outcome|B1 50 mg LD + 65 mg CD|50 mg of MR levodopa + 65 mg of carbidopa
11302487|NCT03055936|OG002|Outcome|C1 50 mg LD + 65 mg CD + 50 mg ODM-104|50 mg of MR levodopa + 65 mg carbidopa + 50 mg ODM-104
11302488|NCT03055936|OG003|Outcome|D1 50 mg LD + 65 mg CD + 100 mg ODM-104|50 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
11302489|NCT03055936|OG004|Outcome|A2 100 mg LD + 25 mg CD|100 mg of MR levodopa + 25 mg of carbidopa
11302490|NCT03055936|OG005|Outcome|B2 100 mg LD + 65 mg CD|100 mg of MR levodopa + 65 mg of carbidopa
11302491|NCT03055936|OG006|Outcome|C2 100 mg of LD + 65 mg CD + 50 mg ODM-104|100 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
11302492|NCT03055936|OG007|Outcome|D2 100 mg LD + 65 mg CD + 100 mg of ODM-104|100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
11302493|NCT03055936|OG008|Outcome|A3 150 mg LD + 37.5 mg CD|150 mg of MR levodopa + 37.5 mg of carbidopa
11302494|NCT03055936|OG009|Outcome|B3 150 mg LD + 65 mg CD|150 mg of MR levodopa + 65 mg of carbidopa
11302495|NCT03055936|OG010|Outcome|C3 150 mg LD + 65 mg CD + 50 mg ODM-104|150 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
11302496|NCT03055936|OG011|Outcome|D3 150 mg LD + 65 mg CD + 100 mg ODM-104|150 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
11302497|NCT03055936|OG012|Outcome|A4 (Sinemet) 100 mg IR LD + 25 mg CD|(Sinemet) 100 mg of IR levodopa + 25 mg of carbidopa
11302498|NCT03055936|OG013|Outcome|B4 100 mg LD + 65 mg CD|100 mg of MR levodopa + 65 mg of carbidopa
11302499|NCT03055936|OG014|Outcome|C4 100 mg LD + 25 mg CD + 100 mg ODM-104|100 mg of MR levodopa + 25 mg of carbidopa + 100 mg of ODM-104
11302500|NCT03055936|OG015|Outcome|D4 100 mg LD + 65 mg CD + 100 mg ODM-104|100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
11302501|NCT03055936|EG000|Reported Event|A1 (Levodopa 50, Carbidopa 12.5)|levodopa 50 mg, carbidopa 12.5 mg
11302502|NCT03055936|EG001|Reported Event|B1 (Levodopa 50, Carbidopa 65)|levodopa 50 mg, carbidopa 65 mg
11302503|NCT03055936|EG002|Reported Event|C1 (Levodopa 50, Carbidopa 65, ODM-104 50)|levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg
11302504|NCT03055936|EG003|Reported Event|D1 (Levodopa 50, Carbidopa 65, ODM-104 100)|levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
11302505|NCT03055936|EG004|Reported Event|A2 (levodopa100, Carbidopa 25)|levodopa 100 mg, carbidopa 25 mg
11302506|NCT03055936|EG005|Reported Event|B2 (Levodopa 100, Carbidopa 65)|levodopa 100 mg, carbidopa 65 mg
11302507|NCT03055936|EG006|Reported Event|C2 (levodopa100, Carbidopa 65, ODM-104 50)|levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg
11302508|NCT03055936|EG007|Reported Event|D2 (Levodopa 100, Carbidopa 65, ODM-104 100)|levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302509|NCT03055936|EG008|Reported Event|A3 (Levodopa 150, Carbidopa 37.5)|levodopa 150 mg, carbidopa 37.5 mg;
11302510|NCT03055936|EG009|Reported Event|B3 (Levodopa 150, Carbidopa 65)|levodopa 150 mg, carbidopa 65 mg
11302511|NCT03055936|EG010|Reported Event|C3 (Levodopa 150, Carbidopa 65, ODM-104 50)|levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg
11302512|NCT03055936|EG011|Reported Event|D3 (Levodopa 150, Carbidopa 65, ODM-104 100)|levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
11302513|NCT03055936|EG012|Reported Event|A4 (Sinemet, Levodopa 100, Carbidopa 25)|levodopa IR (Sinemet) 100 mg, carbidopa 25 mg
11302514|NCT03055936|EG013|Reported Event|B4 (Levodopa 100, Carbidopa 65)|levodopa 100 mg, carbidopa 65 mg
11302515|NCT03055936|EG014|Reported Event|C4 (Levodopa 100, Carbidopa 25, ODM-104 100)|levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg
11302516|NCT03055936|EG015|Reported Event|D4 (Levodopa 100, Carbidopa 65, ODM-104 100)|levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
11302517|NCT03055988|BG000|Baseline|Total Patients|Patients orally inhaled total 2 inhalations daily (one inhalation in the morning and evening) via Accuhaler® inhaler of 1000 microgram (μg) fluticasone propionate + 100 μg salmeterol dry powder for inhalation (F+S 1000/100) (500 μg / 50 μg per actuation) or orally inhaled 2 inhalations once daily (in the morning) via Respimat® inhaler of 5 μg tiotropium + 5 μg olodaterol inhalation solution (T+O 5/5) (2.5 μg /2.5 μg per actuation). Patients were randomly assigned to a treatment sequence in two 6-week periods. There was no washout between treatments.
11302518|NCT03055988|FG000|Participant Flow|FluticasonePropionate+SalmeterolFDC/ Tiotropium+OlodaterolFDC|Patients orally inhaled total 2 inhalations daily (one inhalation in the morning and evening) via Accuhaler® inhaler of 1000 microgram (μg) fluticasone propionate + 100 μg salmeterol dry powder for inhalation (F+S 1000/100) (500 μg / 50 μg per actuation) for 6-week treatment in period 1 and patients orally inhaled 2 inhalations once daily (in the morning) via Respimat® inhaler of 5 μg tiotropium + 5 μg olodaterol inhalation solution (T+O 5/5) (2.5 μg /2.5 μg per actuation) for 6-weeks treatment in period 2. There was no washout between treatments.
11302519|NCT03055988|FG001|Participant Flow|Tiotropium+OlodaterolFDC/ FluticasonePropionate+SalmeterolFDC|Patients orally inhaled 2 inhalations once daily (in the morning) via Respimat® inhaler of 5 μg tiotropium + 5 μg olodaterol inhalation solution (T+O 5/5) (2.5 μg /2.5 μg per actuation) for 6-week treatment in period 1 and patients orally inhaled total 2 inhalations daily (one inhalation in the morning and evening) via Accuhaler® inhaler of 1000 microgram (μg) fluticasone propionate + 100 μg salmeterol dry powder for inhalation (F+S 1000/100) (500 μg / 50 μg per actuation) for 6-weeks treatment in period 2. There was no washout between treatments.
11302520|NCT03055988|OG000|Outcome|Fluticasone Propionate + Salmeterol FDC (F+S 1000/100)|Patients orally inhaled total 2 inhalations daily (one inhalation in the morning and evening) via Accuhaler® inhaler of 1000 microgram (μg) fluticasone propionate + 100 μg salmeterol dry powder for inhalation (F+S 1000/100) (500 μg / 50 μg per actuation) for 6-week treatment period.
11302521|NCT03055988|OG001|Outcome|Tiotropium + Olodaterol FDC (T+O 5/5)|Patients orally inhaled 2 inhalations once daily (in the morning) via Respimat® inhaler of 5 μg tiotropium + 5 μg olodaterol inhalation solution (T+O 5/5) (2.5 μg /2.5 μg per actuation) for 6-week treatment period.
11302522|NCT03055988|EG000|Reported Event|Fluticasone Propionate + Salmeterol FDC (F+S 1000/100)|Patients orally inhaled total 2 inhalations daily (one inhalation in the morning and evening) via Accuhaler® inhaler of 1000 microgram (μg) fluticasone propionate + 100 μg salmeterol dry powder for inhalation (F+S 1000/100) (500 μg / 50 μg per actuation) for 6-week treatment period.
11302523|NCT03055988|EG001|Reported Event|Tiotropium + Olodaterol FDC (T+O 5/5)|Patients orally inhaled 2 inhalations once daily (in the morning) via Respimat® inhaler of 5 μg tiotropium + 5 μg olodaterol inhalation solution (T+O 5/5) (2.5 μg /2.5 μg per actuation) for 6-week treatment period.
11302524|NCT03056040|BG000|Baseline|Ravulizumab|On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.
11302525|NCT03056040|BG001|Baseline|Eculizumab|Participants received 900 mg of eculizumab q2w for 26 weeks.
11302526|NCT03056040|BG002|Baseline|Total|Total of all reporting groups
11302527|NCT03056040|FG000|Participant Flow|Ravulizumab|"On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.~After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 3 years."
11302528|NCT03056040|FG001|Participant Flow|Eculizumab|"Participants received 900 mg of eculizumab q2w for 26 weeks.~After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 3 years."
11302529|NCT03056040|OG000|Outcome|Ravulizumab|On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.
11302530|NCT03056040|OG001|Outcome|Eculizumab|Participants received 900 mg of eculizumab q2w for 26 weeks.
11302531|NCT03056040|EG000|Reported Event|Ravulizumab|On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.
11302532|NCT03056040|EG001|Reported Event|Eculizumab|Participants received 900 mg of eculizumab q2w for 26 weeks.
11302533|NCT03056144|BG000|Baseline|Intervention Group|"The participants will undergo the whole body vibration therapy 1 session per day, 3 days per week for 4 weeks. The whole total whole body therapy session will last 18 minutes with 9 minutes of vibration.~whole body vibration therapy: The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3~st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min~nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min~th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min~th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min >5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min~The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant."
11302534|NCT03056144|FG000|Participant Flow|Intervention Group|"The participants will undergo the whole body vibration therapy 1 session per day, 3 days per week for 4 weeks. The whole total whole body therapy session will last 18 minutes with 9 minutes of vibration.~whole body vibration therapy: The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3~st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min~nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min~th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min~th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min >5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min~The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant."
11302535|NCT03056144|OG000|Outcome|Intervention Group|"The participants will undergo the whole body vibration therapy 1 session per day, 3 days per week for 4 weeks. The whole total whole body therapy session will last 18 minutes with 9 minutes of vibration.~whole body vibration therapy: The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3~st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min~nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min~th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min~th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min >5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min~The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant."
11302536|NCT03056144|EG000|Reported Event|Intervention Group|"The participants will undergo the whole body vibration therapy 1 session per day, 3 days per week for 4 weeks. The whole total whole body therapy session will last 18 minutes with 9 minutes of vibration.~whole body vibration therapy: The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3~st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min~nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min~th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min~th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min >5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min~The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant."
11302537|NCT03056300|BG000|Baseline|Powered Vascular Stapler|All enrolled subjects who had surgery performed using the powered vascular stapler.
11302538|NCT03056300|FG000|Participant Flow|Powered Vascular Stapler|All enrolled subjects who had surgery performed using the powered vascular stapler.
11302539|NCT03056300|OG000|Outcome|Powered Vascular Stapler|All enrolled subjects who had surgery performed using the powered vascular stapler.
11302540|NCT03056300|EG000|Reported Event|Powered Vascular Stapler|All enrolled subjects who had surgery performed using the powered vascular stapler.
11302541|NCT03056352|BG000|Baseline|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes~Metoclopramide: Intravenous medication drip~Diphenhydramine: Intravenous medication drip"
11302542|NCT03056352|FG000|Participant Flow|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes~Metoclopramide: Intravenous medication drip~Diphenhydramine: Intravenous medication drip"
11302543|NCT03056352|OG000|Outcome|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes~Metoclopramide: Intravenous medication drip~Diphenhydramine: Intravenous medication drip"
11302544|NCT03056352|EG000|Reported Event|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes~Metoclopramide: Intravenous medication drip~Diphenhydramine: Intravenous medication drip"
11302545|NCT03056456|BG000|Baseline|Overall Baseline|Participants received individualized doses of LY900014 and Insulin lispro (Humalog) via CSII with various intermittent bolus doses immediately before meals, over 3 days per period.
11302546|NCT03056456|FG000|Participant Flow|Sequence 1|"Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast (B):~Period 1: Insulin lispro (Humalog)~Day 1: B: SD Day 3: B: SD~Period 2: Insulin lispro (Humalog)~Day 1: B: SS Day 3: B: SS~Period 3: LY900014~Day 1: B: SD Day 3: B: SD~Period 4: LY900014~Day 1: B: SS Day 3: B: SS"
11302547|NCT03056456|FG001|Participant Flow|Sequence 2|"Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:~Period 1:Insulin lispro (Humalog)~Day 1: B: SS Day 3: B: SS~Period 2: LY900014~Day 1: B: SS Day 3: B: SS~Period 3: Insulin lispro (Humalog)~Day 1: B: SD Day 3: B: SD~Period 4: LY900014~Day 1: B: SD Day 3: B: SD"
11302548|NCT03056456|FG002|Participant Flow|Sequence 3|"Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:~Period 1: LY900014~Day 1: B: SD Day 3: B: SD~Period 2: Insulin lispro (Humalog)~Day 1: B: SD Day 3: B: SD~Period 3: LY900014~Day 1: B: SS Day 3: B: SS~Period 4: Insulin lispro (Humalog)~Day 1: B: SS Day 3: B: SS"
11302549|NCT03056456|FG003|Participant Flow|Sequence 4|"Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:~Period 1:LY900014~Day 1: B: SS Day 3: B: SS~Period 2: LY900014~Day 1: B: SD Day 3: B: SD~Period 3: Insulin lispro (Humalog)~Day 1: B: SS Day 3: B: SS~Period 4: Insulin lispro (Humalog)~Day 1: B: SD Day 3: B: SD"
11302550|NCT03056456|OG000|Outcome|LY900014 SS|Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Day 1 and 3.
11302551|NCT03056456|OG001|Outcome|Insulin Lispro (Humalog) SS|Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3.
11302552|NCT03056456|OG000|Outcome|LY900014 SD|Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard dual-wave bolus on Day 1 and 3.
11302553|NCT03056456|OG001|Outcome|Insulin Lispro (Humalog) SD|Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermitted bolus dose administered as standard dual-wave bolus on Days 1 and 3.
11302554|NCT03056456|OG000|Outcome|LY900014 SS|Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Days 1 and 3.
11302555|NCT03056456|OG001|Outcome|Insulin Lispro (Humalog) SS|Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Days 1 and 3.
11302556|NCT03056456|OG000|Outcome|LY900014 SD|Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard dual-wave bolus on Days 1 and 3.
11302557|NCT03056456|OG001|Outcome|Insulin Lispro (Humalog) SD|Individualized doses of Insulin lispro (Humalog) delivered via CSII intermitted bolus dose administered as standard dual-wave bolus on Days 1 and 3.
11302558|NCT03056456|EG000|Reported Event|LY900014|LY900014 administered via CSII
11302559|NCT03056456|EG001|Reported Event|Humalog|Humalog administered via CSII
11302560|NCT03056456|EG002|Reported Event|Open-label Humalog|Humalog administered via CSII as post-blinded study standard of care.
11302561|NCT03056573|BG000|Baseline|Subclavian/Axillary Access Arm|Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
10971807|NCT00917384|EG001|Reported Event|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
11302562|NCT03056573|BG001|Baseline|Transaortic Arm|Subjects who underwent Transaortic TAVR implant.
11302563|NCT03056573|BG002|Baseline|Total|Total of all reporting groups
11302564|NCT03056573|FG000|Participant Flow|Subclavian/Axillary Access Arm|Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
11302565|NCT03056573|FG001|Participant Flow|Transaortic Access Arm|Subjects who underwent Transaortic TAVR implant.
11302566|NCT03056573|OG000|Outcome|Subclavian/Axillary Access Arm|Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
11302567|NCT03056573|OG001|Outcome|Transaortic Access Arm|Subjects who underwent Transaortic TAVR implant.
11302568|NCT03056573|EG000|Reported Event|Subclavian/Axillary Access Arm|Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
11302569|NCT03056573|EG001|Reported Event|Transaortic Access Arm|Subjects who underwent Transaortic TAVR implant
11302570|NCT03056690|BG000|Baseline|Placebo|Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302571|NCT03056690|BG001|Baseline|ASP0819 15 mg|Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302572|NCT03056690|BG002|Baseline|Total|Total of all reporting groups
11302573|NCT03056690|FG000|Participant Flow|Placebo|Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302574|NCT03056690|FG001|Participant Flow|ASP0819 15mg|Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302575|NCT03056690|OG000|Outcome|Placebo|Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302576|NCT03056690|OG001|Outcome|ASP0819 15 mg|Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302577|NCT03056690|EG000|Reported Event|Placebo|Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
11302578|NCT03056690|EG001|Reported Event|ASP0819|A single oral dose to be taken preferably in the morning with or without food
11302579|NCT03057132|BG000|Baseline|Cavilon Advanced Skin Protectant|Cavion Advanced Skin Protectant was applied to one male subject.
11302580|NCT03057132|FG000|Participant Flow|Cavilon Advanced Skin Protectant|Single topical application of Cavilon Advanced Skin Protectant to skin around the ostomy
11302581|NCT03057132|OG000|Outcome|Cavilon Advanced Skin Protectant|Assessed area around an ostomy and estimated the percentage of skin that was normal, intact with pink/redness, and had epidermal loss (denuded).
11302582|NCT03057132|OG000|Outcome|Cavilon Advanced Skin Protectant|Pain was rated during and after cleansing at baseline and at Day 3. Pain was rated during and after product application.
11302583|NCT03057132|EG000|Reported Event|Cavilon Advanced Skin Protectant|Cavilon Advanced Skin Protectant-single arm study
10848387|NCT00289783|OG003|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11302584|NCT03057366|BG000|Baseline|[14C]-Pevonedistat 25 mg/m^2|[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626 MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. Participants who completed Part A and provided consent for Part B continued treatment in Part B. Participants received pevonedistat 20 mg/m^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles); or pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the chemotherapies in Part B.
11302585|NCT03057366|FG000|Participant Flow|Part A: [14C]-Pevonedistat 25 mg/m^2|[14C]-pevonedistat (containing approximately 60-98 microcurie [mCi] [approximately 2.22-3.626 megabecquerel (MBq)] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
11302586|NCT03057366|FG001|Participant Flow|Part B: Pevonedistat + Paclitaxel and Carboplatin|Pevonedistat 20 mg/m^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302587|NCT03057366|FG002|Participant Flow|Part B: Pevonedistat + Docetaxel|Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302588|NCT03057366|OG000|Outcome|Part A: [14C]-Pevonedistat 25 mg/m^2|[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626 MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
11302589|NCT03057366|OG001|Outcome|Part B: Pevonedistat + Paclitaxel and Carboplatin|Pevonedistat 20 mg/m^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302590|NCT03057366|OG002|Outcome|Part B: Pevonedistat + Docetaxel|Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302591|NCT03057366|OG000|Outcome|Part B: Pevonedistat + Paclitaxel and Carboplatin|Pevonedistat 20 mg/m^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11332918|NCT03503565|FG000|Participant Flow|Moderate Block Group|"maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11332919|NCT03503565|FG001|Participant Flow|Deep Block Group|"maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11332920|NCT03503565|OG000|Outcome|Moderate Block Group|"maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11302592|NCT03057366|OG001|Outcome|Part B: Pevonedistat + Docetaxel|Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302593|NCT03057366|EG000|Reported Event|Part A: [14C]-Pevonedistat 25 mg/m^2|[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626 MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
11302594|NCT03057366|EG001|Reported Event|Part B: Pevonedistat + Paclitaxel and Carboplatin|Pevonedistat 20 mg/m^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302595|NCT03057366|EG002|Reported Event|Part B: Pevonedistat + Docetaxel|Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
11302596|NCT03057496|BG000|Baseline|Silent and Active Mode|During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Thus the baseline measures are the same for active and silent modes (as it was the same participants for both modes) and are reported together.
11302597|NCT03057496|FG000|Participant Flow|Silent and Active Mode|During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Thus participant flow was the same for silent and active modes and is described for all participants together.
11302598|NCT03057496|OG000|Outcome|Silent Mode|Participants used the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors. The device switched between silent and active mode on a random schedule. In the silent mode the device detected potential collisions but did not provide any active warnings to the users.
11302599|NCT03057496|OG001|Outcome|Active Mode|Participants used the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors. The device switched between silent and active mode on a random schedule. In the active mode the device detected potential collisions and gave active warnings to the users via vibro-tactile wristbands.
11302600|NCT03057496|OG000|Outcome|Silent and Active Mode|Since participants did not know when the device was in either the silent or the active mode, it was not possible for them to answer questions specific to each mode. The questionnaire was completed after using the device for one month and therefore represents ratings of the device for the whole duration of the trial including both active and silent operating modes.
11302601|NCT03057496|EG000|Reported Event|Silent and Active Mode|During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Neither the subject nor the researcher recording adverse events knew whether the device was in silent or active mode at the time when an event occurred, thus the adverse events are reported for all participants and both modes together.
11302606|NCT03057704|BG000|Baseline|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
11302607|NCT03057704|BG001|Baseline|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
11302608|NCT03057704|BG002|Baseline|Total|Total of all reporting groups
11302609|NCT03057704|FG000|Participant Flow|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
11302610|NCT03057704|FG001|Participant Flow|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
11302611|NCT03057704|OG000|Outcome|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
11302612|NCT03057704|OG001|Outcome|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
11302613|NCT03057704|EG000|Reported Event|Intravenous Lidocaine: Flushed|"Lidocaine injection flushed~Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol."
11302614|NCT03057704|EG001|Reported Event|Intravenous Lidocaine: Tourniquet|"Lidocaine injection tourniquet~Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet"
11302615|NCT03057977|BG000|Baseline|Placebo|1 film-coated tablet of matching placebo was administered orally once daily.
11302616|NCT03057977|BG001|Baseline|10 mg Empagliflozin|Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.
11302617|NCT03057977|BG002|Baseline|Total|Total of all reporting groups
11302618|NCT03057977|FG000|Participant Flow|Placebo|1 film-coated tablet of matching placebo was administered orally once daily.
11302619|NCT03057977|FG001|Participant Flow|10 mg Empagliflozin|Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.
11302620|NCT03057977|OG000|Outcome|Placebo|1 film-coated tablet of matching placebo was administered orally once daily.
11302621|NCT03057977|OG001|Outcome|10 mg Empagliflozin|Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.
11302622|NCT03057977|EG000|Reported Event|Placebo|1 film-coated tablet of matching placebo was administered orally once daily.
11302623|NCT03057977|EG001|Reported Event|10 mg Empagliflozin|Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.
11302624|NCT03058679|BG000|Baseline|Mediterranean Style Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302625|NCT03058679|BG001|Baseline|Specific Carbohydrate Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302626|NCT03058679|BG002|Baseline|Total|Total of all reporting groups
11302627|NCT03058679|FG000|Participant Flow|Specific Carbohydrate Diet|Diet: food for the diet will be provided to the participants for 6 weeks
11302628|NCT03058679|FG001|Participant Flow|Mediterranean Style Diet|Diet: food for the diet will be provided to the participants for 6 weeks
11302629|NCT03058679|OG000|Outcome|Mediterranean Style Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302630|NCT03058679|OG001|Outcome|Specific Carbohydrate Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302631|NCT03058679|EG000|Reported Event|Mediterranean Style Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302632|NCT03058679|EG001|Reported Event|Specific Carbohydrate Diet|Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
11302633|NCT03058692|BG000|Baseline|M-001 + IIV4|0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
11302634|NCT03058692|BG001|Baseline|Placebo + IIV4|0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
11302635|NCT03058692|BG002|Baseline|Total|Total of all reporting groups
11302636|NCT03058692|FG000|Participant Flow|M-001 + IIV4|"0.4 ml injection of M-001 (1 mg dose) intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172~Influenza Multimeric-001 Vaccine: The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.~Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine."
11302637|NCT03058692|FG001|Participant Flow|Placebo + IIV4|"0.4 ml injection of placebo intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172~Placebo: Placebo is saline injection~Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine."
11302638|NCT03058692|OG000|Outcome|M-001 + IIV4|0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
11302639|NCT03058692|OG001|Outcome|Placebo + IIV4|0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
11302640|NCT03058692|OG001|Outcome|Placebo + IIV4|0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
11302641|NCT03058692|EG000|Reported Event|M-001 + IIV4|0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
11302642|NCT03058692|EG001|Reported Event|Placebo + IIV4|0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
11302643|NCT03058991|BG000|Baseline|Working Memory Intervention|"Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different games that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation."
11302644|NCT03058991|BG001|Baseline|Control Informational Intervention|This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.
11332921|NCT03503565|OG001|Outcome|Deep Block Group|"maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11332922|NCT03503565|EG000|Reported Event|Moderate Block Group|"maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11332923|NCT03503565|EG001|Reported Event|Deep Block Group|"maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery~intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade"
11302645|NCT03058991|BG002|Baseline|Distress Tolerance Intervention|For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
11302646|NCT03058991|BG003|Baseline|Total|Total of all reporting groups
11302647|NCT03058991|FG000|Participant Flow|Working Memory Intervention|"Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different games that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation."
11302648|NCT03058991|FG001|Participant Flow|Control Informational Intervention|This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.
11302649|NCT03058991|FG002|Participant Flow|Distress Tolerance Intervention|For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
11302650|NCT03058991|OG000|Outcome|Working Memory Intervention|"Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different games that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation."
11302651|NCT03058991|OG001|Outcome|Control Informational Intervention|This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.
11302652|NCT03058991|OG002|Outcome|Distress Tolerance Intervention|For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
11302653|NCT03058991|EG000|Reported Event|Distress Tolerance Intervention|"For the Distress Tolerance Intervention, the investigators will use a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators will make slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes will also allow the investigators to match the duration with their Working Memory Intervention.~Distress Tolerance Intervention: See arm/group description."
11302654|NCT03058991|EG001|Reported Event|Working Memory Intervention|"For the working memory training, the investigators will use the Cogmed RM program. Participants will be asked to use the program, while supervised twice a week, each time for an hour, for 8 weeks. Participants will also be asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different games that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.~Working Memory Intervention: See arm/group description."
11302655|NCT03058991|EG002|Reported Event|Control Informational Intervention|"This Control Informational Intervention has been used in the investigators' and other's previous studies. In the current application, it will match the session time of the Distress Tolerance and Working Memory interventions and will omit a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.~Control Informational Intervention: See arm/group description."
11302656|NCT03059810|BG000|Baseline|Etafilcon A With PVP|All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
11302657|NCT03059810|FG000|Participant Flow|Etafilcon A With PVP|All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
11302658|NCT03059810|OG000|Outcome|Etafilcon A With PVP|All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
11302659|NCT03059810|EG000|Reported Event|Etafilcon A With PVP|All subjects wore the etafilcon A lens with PVP throughout the entire duration of the study.
11302660|NCT03059901|BG000|Baseline|More App Notifications|"Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302661|NCT03059901|BG001|Baseline|Normal App Notifications|"Participants receive less notifications than the Experimental group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302662|NCT03059901|BG002|Baseline|Total|Total of all reporting groups
11302663|NCT03059901|FG000|Participant Flow|More App Notifications|"Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302664|NCT03059901|FG001|Participant Flow|Normal App Notifications|"Participants receive less notifications than the Experimental group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302665|NCT03059901|OG000|Outcome|More App Notifications|"Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302666|NCT03059901|OG001|Outcome|Normal App Notifications|"Participants receive less notifications than the Experimental group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302667|NCT03059901|EG000|Reported Event|More App Notifications|"Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302668|NCT03059901|EG001|Reported Event|Normal App Notifications|"Participants receive less notifications than the Experimental group from the Caminamos app to walk.~Caminamos App: Mobile phone that encourages Latina women to walk together through social support."
11302669|NCT03060447|BG000|Baseline|Vesatolimod|Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302670|NCT03060447|BG001|Baseline|Placebo|Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302671|NCT03060447|BG002|Baseline|Total|Total of all reporting groups
11302672|NCT03060447|FG000|Participant Flow|Vesatolimod|Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed antiretroviral treatment (ART). Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302673|NCT03060447|FG001|Participant Flow|Placebo|Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302674|NCT03060447|OG000|Outcome|Vesatolimod 4 mg|Participants in Period 1 received 10 doses of vesatolimod 4 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11332924|NCT03503578|BG000|Baseline|EEG Dynamics|"EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.~Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes.~Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes."
11332925|NCT03503578|FG000|Participant Flow|EEG Dynamics|"EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.~Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes.~Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes."
11302675|NCT03060447|OG001|Outcome|Vesatolimod 4/6 mg|Participants in Period 1 received 10 doses of vesatolimod 4 mg or 6 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302676|NCT03060447|OG002|Outcome|Vesatolimod 6 mg|Participants in Period 1 received 10 doses of vesatolimod 6 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302677|NCT03060447|OG003|Outcome|Vesatolimod 6/8 mg|Participants in Period 1 received 10 doses of vesatolimod 6 mg or 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302678|NCT03060447|OG004|Outcome|Vesatolimod 8 mg|Participants in Period 1 received 10 doses of vesatolimod 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302679|NCT03060447|OG005|Outcome|Placebo|Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302680|NCT03060447|OG000|Outcome|Vesatolimod|Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302681|NCT03060447|OG001|Outcome|Placebo|Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302682|NCT03060447|EG000|Reported Event|Vesatolimod|Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11302683|NCT03060447|EG001|Reported Event|Placebo|Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
11332926|NCT03503578|OG000|Outcome|EEG Dynamics|EEG data will be collected on patients receiving sevoflurane anesthesia.
11302684|NCT03060486|BG000|Baseline|HYBENX®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.~Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle."
11302685|NCT03060486|FG000|Participant Flow|HYBENX®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.~Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle."
11302686|NCT03060486|OG000|Outcome|HYBENX®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.~Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle."
11302687|NCT03060486|EG000|Reported Event|HYBENX®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.~Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle."
11302688|NCT03060512|BG000|Baseline|Movantik, Then PEG 3350|Subjects received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2).
11302689|NCT03060512|BG001|Baseline|PEG 3350, Then Movantik|Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2).
11302690|NCT03060512|BG002|Baseline|Total|Total of all reporting groups
11302691|NCT03060512|FG000|Participant Flow|Movantik, Then PEG 3350|Subjects received Movantik 25 milligrams (mg) once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Polyethylene Glycol 3350 (PEG 3350) 17 grams (g) of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2).
11302692|NCT03060512|FG001|Participant Flow|PEG 3350, Then Movantik|Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2).
11302693|NCT03060512|OG000|Outcome|Total (PP Set)|All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.
11302694|NCT03060512|OG000|Outcome|Movantik, Then PEG 3350|Subjects received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2).
11302695|NCT03060512|OG001|Outcome|PEG 3350, Then Movantik|Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2).
11302696|NCT03060512|OG000|Outcome|Preferred Movantik|Subjects who preferred Movantik for the treatment of OIC had selected Strong preference for Movantik, Moderate preference for Movantik or Slight preference for Movantik during the Patient Preference Assessment at Visit 5.
11302697|NCT03060512|OG001|Outcome|Preferred PEG 3350|Subjects who preferred PEG 3350 had selected Strong preference for PEG 3350, Moderate preference for PEG 3350 or Slight preference for PEG 3350 during the Patient Preference Assessment at Visit 5.
11302698|NCT03060512|OG000|Outcome|Movantik FAS|The Movantik FAS consisted of all subjects who satisfied the inclusion and exclusion criteria, received Movantik, and attended at least one scheduled visit.
11302699|NCT03060512|OG001|Outcome|PEG 3350 FAS|The PEG 3350 FAS consisted of all subjects who satisfied the inclusion and exclusion criteria, received PEG 3350, and attended at least one scheduled visit.
11302700|NCT03060512|EG000|Reported Event|Movantik|The Movantik treatment-emergent safety set included all subjects exposed to at least one dose of Movantik.
11302701|NCT03060512|EG001|Reported Event|PEG 3350|The PEG 3350 treatment-emergent safety set included all subjects exposed to at least one dose of PEG 3350.
11302702|NCT03060551|BG000|Baseline|SVF Injection|"SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles~SVF injection: SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis"
11302703|NCT03060551|FG000|Participant Flow|SVF Injection Group|Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
11302704|NCT03060551|OG000|Outcome|SVF Injection Group|Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
11302705|NCT03060551|EG000|Reported Event|SVF Injection Group|Participants received SVF treatment. All patients were regulary assessed at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
11302706|NCT03060759|BG000|Baseline|Light Therapy-Spectrum 1|"Light from 'active' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302707|NCT03060759|BG001|Baseline|Light Therapy-Spectrum 2|"Light from 'placebo' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302708|NCT03060759|BG002|Baseline|Total|Total of all reporting groups
11302709|NCT03060759|FG000|Participant Flow|Light Therapy-Spectrum 1|"Light from 'active' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302710|NCT03060759|FG001|Participant Flow|Light Therapy-Spectrum 2|"Light from 'placebo' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302711|NCT03060759|OG000|Outcome|Light Therapy-Spectrum 1|"Light from 'active' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302712|NCT03060759|OG001|Outcome|Light Therapy-Spectrum 2|"Light from 'placebo' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302713|NCT03060759|EG000|Reported Event|Light Therapy-Spectrum 1|"Light from 'active' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302714|NCT03060759|EG001|Reported Event|Light Therapy-Spectrum 2|"Light from 'placebo' spectrum~Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
11302715|NCT03061097|BG000|Baseline|Treatment (Autologous Fecal Microbiota Preparation)|"Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months.~Route of Administration: Enema Dosing Regimen: 125mL x 1 dose~Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation."
11302716|NCT03061097|BG001|Baseline|Placebo|"Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.~Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms."
11302717|NCT03061097|BG002|Baseline|Total|Total of all reporting groups
11332927|NCT03503578|EG000|Reported Event|EEG Dynamics|"EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.~Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes.~Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes."
11302718|NCT03061097|FG000|Participant Flow|Treatment (Autologous Fecal Microbiota Preparation)|"Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months.~Route of Administration: Enema Dosing Regimen: 125mL x 1 dose~Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation."
11302719|NCT03061097|FG001|Participant Flow|Placebo|"Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.~Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms."
11302720|NCT03061097|OG000|Outcome|Treatment (Autologous Fecal Microbiota Preparation)|"Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months.~Route of Administration: Enema Dosing Regimen: 125mL x 1 dose~Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation."
11302721|NCT03061097|OG001|Outcome|Placebo|"Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.~Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms."
11302722|NCT03061097|EG000|Reported Event|Treatment (Autologous Fecal Microbiota Preparation)|"Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months.~Route of Administration: Enema Dosing Regimen: 125mL x 1 dose~Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation."
11302723|NCT03061097|EG001|Reported Event|Placebo|"Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.~Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms."
11302724|NCT03061175|BG000|Baseline|Arm I (Web-Based CPM-DA)|"Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.~Internet-Based Intervention: Receive web-based CPM-DA~Survey Administration: Ancillary studies"
11302725|NCT03061175|BG001|Baseline|Arm II (Usual Care)|"Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.~Survey Administration: Ancillary studies"
11302726|NCT03061175|BG002|Baseline|Total|Total of all reporting groups
11302727|NCT03061175|FG000|Participant Flow|Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)|"Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)-Decision Aid (DA).~Internet-Based Intervention: Receive web-based CPM-DA~Survey Administration: Ancillary studies"
11302728|NCT03061175|FG001|Participant Flow|Arm II (Usual Care)|"Patients undergo usual care available to patients considering Contralateral Prophylactic Mastectomy (CPM) and receive information from a medical oncologist about CPM.~Survey Administration: Ancillary studies"
11302729|NCT03061175|OG000|Outcome|Arm I (Web-Based CPM-DA)|"Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.~Internet-Based Intervention: Receive web-based CPM-DA~Survey Administration: Ancillary studies"
11302730|NCT03061175|OG001|Outcome|Arm II (Usual Care)|"Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.~Survey Administration: Ancillary studies"
11302731|NCT03061175|EG000|Reported Event|Arm I (Web-Based CPM-DA)|"Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.~Internet-Based Intervention: Receive web-based CPM-DA~Survey Administration: Ancillary studies"
11302732|NCT03061175|EG001|Reported Event|Arm II (Usual Care)|"Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.~Survey Administration: Ancillary studies"
11302733|NCT03061188|BG000|Baseline|Velaparib PO Twice Daily + Nivolumab (Cohort -1)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose in Phase 1: Cohort -1: 200mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302734|NCT03061188|BG001|Baseline|Velaparib PO Twice Daily + Nivolumab (Cohort 1)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose in Phase 1: Cohort 1: 300 mg,~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302735|NCT03061188|BG002|Baseline|Velaparib PO Twice Daily + Nivolumab (Cohort 2)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose: 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302736|NCT03061188|BG003|Baseline|Velaparib PO Twice Daily + Nivolumab (Phase 2)|"Patients in all Phase 1 cohorts and Phase 2 receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302737|NCT03061188|BG004|Baseline|Total|Total of all reporting groups
11302738|NCT03061188|FG000|Participant Flow|Phase 1:Cohort-1 (Velaparib 200 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 200 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302739|NCT03061188|FG001|Participant Flow|Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 300 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302740|NCT03061188|FG002|Participant Flow|Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302741|NCT03061188|FG003|Participant Flow|Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab|"Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302742|NCT03061188|OG000|Outcome|Velaparib PO Twice Daily + Nivolumab (Phase 1)|"Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302743|NCT03061188|OG000|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 1)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose in Phase 1: Cohort 1: 300 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO"
11302744|NCT03061188|OG001|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 2)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose: 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302745|NCT03061188|OG002|Outcome|Velaparib PO Twice Daily + Nivolumab (Phase 2)|"Patients in all Phase 1 cohorts and Phase 2 receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302746|NCT03061188|OG000|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 1)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose in Phase 1: Cohort 1: 300 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory~Biomarker Analysis: Correlative studies~Nivolumab: Given IV Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302747|NCT03061188|OG001|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 2)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose: 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO"
11332928|NCT03504189|BG000|Baseline|PregSense™|"PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring~PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring~Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring"
11302748|NCT03061188|OG002|Outcome|Velaparib PO Twice Daily + Nivolumab (Phase 2)|"Patients in all Phase 1 cohorts and Phase 2 receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib"
11302749|NCT03061188|OG001|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 2 + Phase 2)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose: 400 mg~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1)~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302750|NCT03061188|OG000|Outcome|Velaparib PO Twice Daily + Nivolumab (Cohort 1)|"Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Velaparib dose in Phase 1: Cohort 1: 300 mg,~Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 & 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO"
11302751|NCT03061188|EG000|Reported Event|Phase 1:Cohort-1 (Velaparib 200 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 200 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302752|NCT03061188|EG001|Reported Event|Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 300 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302753|NCT03061188|EG002|Reported Event|Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab)|"Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302754|NCT03061188|EG003|Reported Event|Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab|"Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Nivolumab: Given IV~Pharmacological Study: Correlative studies~Veliparib: Given PO"
11302755|NCT03061214|BG000|Baseline|Semaglutide 0.5 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302756|NCT03061214|BG001|Baseline|Semaglutide 1.0 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302757|NCT03061214|BG002|Baseline|Sitagliptin|Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302758|NCT03061214|BG003|Baseline|Total|Total of all reporting groups
11302759|NCT03061214|FG000|Participant Flow|Semaglutide 0.5 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302760|NCT03061214|FG001|Participant Flow|Semaglutide 1.0 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302761|NCT03061214|FG002|Participant Flow|Sitagliptin|Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302762|NCT03061214|OG000|Outcome|Semaglutide 0.5 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302763|NCT03061214|OG001|Outcome|Semaglutide 1.0 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302764|NCT03061214|OG002|Outcome|Sitagliptin|Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302765|NCT03061214|EG000|Reported Event|Semaglutide 0.5 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302766|NCT03061214|EG001|Reported Event|Semaglutide 1.0 mg|Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302767|NCT03061214|EG002|Reported Event|Sitagliptin|Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial.
11302768|NCT03061331|BG000|Baseline|Sequence 1: First LUM/IVA, Then Placebo|Participants received LUM 400 mg/IVA 250 mg fixed dose combination tablet orally q12h for 8 weeks in treatment period 1 followed by placebo matched to LUM/IVA tablet orally q12h for 8 weeks in treatment period 2. Two treatment periods were separated by 8-week washout period.
11302769|NCT03061331|BG001|Baseline|Sequence 2: First Placebo, Then LUM/IVA|Participants received placebo matched to LUM/IVA tablet orally q12h for 8 weeks in treatment period 1 followed by LUM 400 mg/IVA 250 mg fixed dose combination tablet orally q12h for 8 weeks in treatment period 2. Two treatment periods were separated by 8-week washout period.
11302770|NCT03061331|BG002|Baseline|Total|Total of all reporting groups
11302771|NCT03061331|FG000|Participant Flow|Sequence 1: First LUM/IVA, Then Placebo|Participants received Lumacaftor (LUM) 400 milligram (mg)/Ivacaftor (IVA) 250 mg fixed dose combination tablet orally every 12 hours (q12h) for 8 weeks in treatment period 1 followed by placebo matched to LUM/IVA tablet orally q12h for 8 weeks in treatment period 2. Two treatment periods were separated by 8-week washout period.
11302772|NCT03061331|FG001|Participant Flow|Sequence 2: First Placebo, Then LUM/IVA|Participants received placebo matched to LUM/IVA tablet orally q12h for 8 weeks in treatment period 1 followed by LUM 400 mg/IVA 250 mg fixed dose combination tablet orally q12h for 8 weeks in treatment period 2. Two treatment periods were separated by 8-week washout period.
11302773|NCT03061331|OG000|Outcome|Placebo|Placebo matched to LUM/IVA q12h for 8 weeks in Treatment Period 1 or 2
11302774|NCT03061331|OG001|Outcome|LUM/IVA|LUM 400 mg/IVA 250 mg fixed dose combination q12h for 8 weeks in Treatment Period 1 or 2.
11302775|NCT03061331|EG000|Reported Event|Placebo|Placebo matched to LUM/IVA q12h for 8 weeks in Treatment Period 1 or 2.
11302776|NCT03061331|EG001|Reported Event|LUM/IVA|LUM 400 mg/IVA 250 mg fixed dose combination q12h for 8 weeks in Treatment Period 1 or 2.
11302777|NCT03061513|BG000|Baseline|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
11302778|NCT03061513|BG001|Baseline|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
11302779|NCT03061513|BG002|Baseline|Total|Total of all reporting groups
11302780|NCT03061513|FG000|Participant Flow|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
11302781|NCT03061513|FG001|Participant Flow|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
11302782|NCT03061513|OG000|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
11302783|NCT03061513|OG001|Outcome|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
11302784|NCT03061513|EG000|Reported Event|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
11302785|NCT03061513|EG001|Reported Event|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
11302786|NCT03061812|BG000|Baseline|Topotecan|Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.
11302787|NCT03061812|BG001|Baseline|Rovalpituzumab Tesirine|"Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.~Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered."
11302788|NCT03061812|BG002|Baseline|Total|Total of all reporting groups
11302789|NCT03061812|FG000|Participant Flow|Topotecan|Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.
11302790|NCT03061812|FG001|Participant Flow|Rovalpituzumab Tesirine|"Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.~Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered."
11302791|NCT03061812|OG000|Outcome|Topotecan|Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.
11302792|NCT03061812|OG001|Outcome|Rovalpituzumab Tesirine|"Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.~Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered."
11302793|NCT03061812|EG000|Reported Event|Topotecan|Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.
11302794|NCT03061812|EG001|Reported Event|Rovalpituzumab Tesirine|"Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted.~Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered."
11302795|NCT03062228|BG000|Baseline|Controls|"Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.~No interventions will be administered."
11302796|NCT03062228|FG000|Participant Flow|Controls|"Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.~No interventions will be administered."
11302797|NCT03062228|OG000|Outcome|Controls|"Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.~No interventions will be administered."
11302798|NCT03062228|EG000|Reported Event|Controls|"Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.~No interventions will be administered."
11302799|NCT03062267|BG000|Baseline|Treatment as Usual|Treatment as usual for 3 months.
11302800|NCT03062267|BG001|Baseline|Mobile Interventionist|"Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.~Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)"
11302801|NCT03062267|BG002|Baseline|Total|Total of all reporting groups
11302802|NCT03062267|FG000|Participant Flow|Treatment as Usual|Treatment as usual for 3 months.
11302803|NCT03062267|FG001|Participant Flow|Mobile Interventionist|"Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.~Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)"
11302804|NCT03062267|OG000|Outcome|Treatment as Usual|Treatment as usual for 3 months.
11302805|NCT03062267|OG001|Outcome|Mobile Interventionist|"Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.~Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)"
11302806|NCT03062267|EG000|Reported Event|Treatment as Usual|Treatment as usual for 3 months.
11302807|NCT03062267|EG001|Reported Event|Mobile Interventionist|"Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.~Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)"
11302808|NCT03062488|BG000|Baseline|Opioid Only|"2 mcg/Kg of fentanyl~Fentanyl: single modal analgesia"
11302809|NCT03062488|BG001|Baseline|Opioid Plus PO Analgesic|"2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg~Fentanyl: single modal analgesia~PO acetaminophen: multi-modal analgesia with PO acetaminophen"
11302810|NCT03062488|BG002|Baseline|Opioid Plus IV Acetaminophen|"2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen~IV acetaminophen: multi-modal analgesia with IV acetaminophen~Fentanyl: single modal analgesia"
11302811|NCT03062488|BG003|Baseline|Total|Total of all reporting groups
11302812|NCT03062488|FG000|Participant Flow|Opioid Only|"2 mcg/Kg of fentanyl~Fentanyl: single modal analgesia"
11302813|NCT03062488|FG001|Participant Flow|Opioid Plus PO Analgesic|"2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg~Fentanyl: single modal analgesia~PO acetaminophen: multi-modal analgesia with PO acetaminophen"
11302814|NCT03062488|FG002|Participant Flow|Opioid Plus IV Acetaminophen|"2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen~IV acetaminophen: multi-modal analgesia with IV acetaminophen~Fentanyl: single modal analgesia"
11302815|NCT03062488|OG000|Outcome|Opioid Only|"2 mcg/Kg of fentanyl~Fentanyl: single modal analgesia"
11302816|NCT03062488|OG001|Outcome|Opioid Plus PO Analgesic|"2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg~Fentanyl: single modal analgesia~PO acetaminophen: multi-modal analgesia with PO acetaminophen"
11302817|NCT03062488|OG002|Outcome|Opioid Plus IV Acetaminophen|"2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen~IV acetaminophen: multi-modal analgesia with IV acetaminophen~Fentanyl: single modal analgesia"
11302818|NCT03062488|EG000|Reported Event|Opioid Only|"2 mcg/Kg of fentanyl~Fentanyl: single modal analgesia"
11302819|NCT03062488|EG001|Reported Event|Opioid Plus PO Analgesic|"2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg~Fentanyl: single modal analgesia~PO acetaminophen: multi-modal analgesia with PO acetaminophen"
11302820|NCT03062488|EG002|Reported Event|Opioid Plus IV Acetaminophen|"2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen~IV acetaminophen: multi-modal analgesia with IV acetaminophen~Fentanyl: single modal analgesia"
11302821|NCT03062605|BG000|Baseline|Treatment(TX)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute~Iodine (Betadine)~NaOCL"
11302822|NCT03062605|BG001|Baseline|Control (CT)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.~Iodine (Betadine)"
11302823|NCT03062605|BG002|Baseline|Total|Total of all reporting groups
11302824|NCT03062605|FG000|Participant Flow|Treatment(TX)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute~Iodine (Betadine)~NaOCL"
11302825|NCT03062605|FG001|Participant Flow|Control (CT)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.~Iodine (Betadine)"
11302826|NCT03062605|OG000|Outcome|Treatment(TX)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute~Iodine (Betadine)~NaOCL"
11302827|NCT03062605|OG001|Outcome|Control (CT)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.~Iodine (Betadine)"
11302828|NCT03062605|EG000|Reported Event|Treatment(TX)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute~Iodine (Betadine)~NaOCL"
11302829|NCT03062605|EG001|Reported Event|Control (CT)|"Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute.~Iodine (Betadine)"
11302830|NCT03062891|BG000|Baseline|Online CBT for Insomnia|"CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.~CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4)."
11302831|NCT03062891|BG001|Baseline|Puzzles|Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes).
11302832|NCT03062891|BG002|Baseline|Total|Total of all reporting groups
11302833|NCT03062891|FG000|Participant Flow|Online CBT for Insomnia|"CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.~CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4)."
11302834|NCT03062891|FG001|Participant Flow|Puzzles|Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes).
11302835|NCT03062891|OG000|Outcome|Online CBT for Insomnia|"CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.~CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4)."
11302836|NCT03062891|OG001|Outcome|Puzzles|Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes).
11302837|NCT03062891|OG000|Outcome|All Participants|For these analyses, the effect of interest is associations between exploding head syndrome (measured at baseline), and measures of insomnia (Sleep Condition Indicator), anxiety (State/Trait Anxiety Index), depression (Mood and Feelings Questionnaire), stress (Perceived Stress Scale), and sleep paralysis (single item). As such, there is a single obtained value (the regression coefficient + 95% confidence interval).
11302838|NCT03062891|EG000|Reported Event|Online CBT for Insomnia|"CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.~CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4)."
11302839|NCT03062891|EG001|Reported Event|Puzzles|Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes).
11302840|NCT03062917|BG000|Baseline|Emergency Department|"Babies with suspected respiratory tract infection (RTI) in the ED~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
10971808|NCT00917462|BG000|Baseline|Sorafenib|"Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.~Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug."
10971809|NCT00917462|FG000|Participant Flow|Sorafenib|"Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.~Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug."
10971810|NCT00917462|OG000|Outcome|Sorafenib|"Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.~Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug."
10971811|NCT00917462|EG000|Reported Event|Sorafenib|"Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.~Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug."
10971812|NCT00917501|BG000|Baseline|Placebo|Olive oil - 3 capsules/day
10971813|NCT00917501|BG001|Baseline|Omega-3|Fish oil - 3 capsules/day
10971814|NCT00917501|BG002|Baseline|Total|Total of all reporting groups
10971815|NCT00917501|FG000|Participant Flow|Placebo|Olive oil - 3 capsules/day
10971816|NCT00917501|FG001|Participant Flow|Omega-3|Fish oil - 3 capsules/day
10971817|NCT00917501|OG000|Outcome|Placebo|Olive oil - 3 capsules/day
10971818|NCT00917501|OG001|Outcome|Omega-3|Fish oil - 3 capsules/day
10971819|NCT00917501|EG000|Reported Event|Placebo|Olive oil - 3 capsules/day
10971820|NCT00917501|EG001|Reported Event|Omega-3|Fish oil - 3 capsules/day
10971821|NCT00917553|BG000|Baseline|Placebo|"Placebo~Placebo: Cellulose Placebo Capsule"
10971822|NCT00917553|BG001|Baseline|Doxycycline Monohydrate|doxycycline monohydrate: 50 mg
10971823|NCT00917553|BG002|Baseline|Total|Total of all reporting groups
10971824|NCT00917553|FG000|Participant Flow|Placebo|"Placebo~Placebo: Cellulose Placebo Capsule"
10971825|NCT00917553|FG001|Participant Flow|Doxycycline Monohydrate|doxycycline monohydrate: 50 mg
10971826|NCT00917553|OG000|Outcome|Placebo|"Placebo~Placebo: Cellulose Placebo Capsule"
10971827|NCT00917553|OG001|Outcome|Doxycycline Monohydrate|doxycycline monohydrate: 50 mg
10971828|NCT00917553|EG000|Reported Event|Placebo|"Placebo~Placebo: Cellulose Placebo Capsule"
10971829|NCT00917553|EG001|Reported Event|Doxycycline Monohydrate|doxycycline monohydrate: 50 mg
10971830|NCT00917579|BG000|Baseline|Total Number of Participants|All participants received atorvastatin 10 mg tablets (new and marketed).
10971831|NCT00917579|FG000|Participant Flow|Test Drug First, Then Reference Drug|New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
10971832|NCT00917579|FG001|Participant Flow|Reference Drug First, Then Test Drug|Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
10971833|NCT00917579|OG000|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
10971834|NCT00917579|OG001|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
10971835|NCT00917579|EG000|Reported Event|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose.
10971836|NCT00917579|EG001|Reported Event|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
10971837|NCT00917644|BG000|Baseline|Total Study Population|New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
11302841|NCT03062917|BG001|Baseline|Paediatric Wards|"Babies with diagnosed RSV infection admitted to paediatric wards~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302842|NCT03062917|BG002|Baseline|Paediatric Intensive Care|"Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302843|NCT03062917|BG003|Baseline|Health Controls|"Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302844|NCT03062917|BG004|Baseline|Controls in Paediatric Intensive Care|"Babies without RSV infection but requiring mechanical ventilation in PICU~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302845|NCT03062917|BG005|Baseline|Total|Total of all reporting groups
11302846|NCT03062917|FG000|Participant Flow|Emergency Department|"Babies with suspected respiratory tract infection (RTI) in the ED~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302847|NCT03062917|FG001|Participant Flow|Paediatric Wards|"Babies with diagnosed RSV infection admitted to paediatric wards~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302848|NCT03062917|FG002|Participant Flow|Paediatric Intensive Care|"Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302849|NCT03062917|FG003|Participant Flow|Health Controls|"Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302850|NCT03062917|FG004|Participant Flow|Controls in Paediatric Intensive Care|"Babies without RSV infection but requiring mechanical ventilation in PICU~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302851|NCT03062917|OG000|Outcome|Wards|None sedated participants recruited from general paediatric wards
11302852|NCT03062917|OG001|Outcome|Emergency Department|Non-ventilated participants recruited from the emergency department
11302853|NCT03062917|OG000|Outcome|All Participants|Correlation between measurements of viral load and cytokines between nasosorption and NPA samples
11302854|NCT03062917|OG000|Outcome|All Participants|Correlation between measurements of cytokines (exemplified by Interferon-gamma) between nasosorption and NPA samples
10848388|NCT00289783|OG004|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11302855|NCT03062917|EG000|Reported Event|Emergency Department|"Babies with suspected respiratory tract infection (RTI) in the ED~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302856|NCT03062917|EG001|Reported Event|Paediatric Wards|"Babies with diagnosed RSV infection admitted to paediatric wards~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302857|NCT03062917|EG002|Reported Event|Paediatric Intensive Care|"Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302858|NCT03062917|EG003|Reported Event|Health Controls|"Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302859|NCT03062917|EG004|Reported Event|Controls in Paediatric Intensive Care|"Babies without RSV infection but requiring mechanical ventilation in PICU~Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling."
11302860|NCT03063086|BG000|Baseline|All Participants|All participants randomized to one of six treatment sequences
11302861|NCT03063086|FG000|Participant Flow|Sequence 1 (A-B-C)|QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.
11302862|NCT03063086|FG001|Participant Flow|Sequence 2(A-C-B)|QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d;
11302863|NCT03063086|FG002|Participant Flow|Sequence 3(B-C-A)|QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/80 μg o.d
11302864|NCT03063086|FG003|Participant Flow|Sequence 4(B-A-C)|QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d
11302865|NCT03063086|FG004|Participant Flow|Sequence 5(C-A-B)|salmeterol/fluticasone FDC 50/500 μg b.i.d; QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d
11302866|NCT03063086|FG005|Participant Flow|Sequence 6(C-B-A)|salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d
11302867|NCT03063086|OG000|Outcome|QVM149 150/50/160 μg o.d.|QVM149 150/50/160 μg o.d.
11302868|NCT03063086|OG001|Outcome|QVM149 150/50/80 μg o.d.|QVM149 150/50/80 μg o.d.
11302869|NCT03063086|OG002|Outcome|Salmeterol/Fluticasone 50/500 µg b.i.d|salmeterol/fluticasone 50/500 µg b.i.d
11302870|NCT03063086|OG002|Outcome|Salmeterol/Fluticasone 50/500 μg b.i.d|Salmeterol/fluticasone 50/500 μg b.i.d
11302871|NCT03063086|EG000|Reported Event|QVM149 150/50/160 µg o.d.|QVM149 150/50/160 µg o.d.
11302872|NCT03063086|EG001|Reported Event|QVM149 150/50/80 µg o.d.|QVM149 150/50/80 µg o.d.
11302873|NCT03063086|EG002|Reported Event|Salmeterol/Fluticasone 50/500 µg b.i.d.|Salmeterol/fluticasone 50/500 µg b.i.d.
11302874|NCT03063125|BG000|Baseline|Bladder Cancer Patients|Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
11302875|NCT03063125|FG000|Participant Flow|Bladder Cancer Patients|Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
11302876|NCT03063125|OG000|Outcome|Bladder Cancer Patients|Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
11302877|NCT03063125|EG000|Reported Event|Bladder Cancer Patients|Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
11302878|NCT03063255|BG000|Baseline|Obturator Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.~Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302879|NCT03063255|BG001|Baseline|Neuromuscular Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.~Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302880|NCT03063255|BG002|Baseline|Total|Total of all reporting groups
11302881|NCT03063255|FG000|Participant Flow|Obturator Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.~Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302882|NCT03063255|FG001|Participant Flow|Neuromuscular Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.~Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302883|NCT03063255|OG000|Outcome|Obturator Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.~Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302884|NCT03063255|OG001|Outcome|Neuromuscular Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.~Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302885|NCT03063255|EG000|Reported Event|Obturator Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.~Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302886|NCT03063255|EG001|Reported Event|Neuromuscular Block|"Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.~Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction."
11302887|NCT03063294|BG000|Baseline|Toolkit Only|"Clinics in this arm are given access to an online care coordination toolkit.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes."
11302888|NCT03063294|BG001|Baseline|Toolkit Plus Coaching|"Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.~Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic."
11302889|NCT03063294|BG002|Baseline|Total|Total of all reporting groups
11302890|NCT03063294|FG000|Participant Flow|Toolkit Only|"Clinics in this arm are given access to an online care coordination toolkit.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes."
11302891|NCT03063294|FG001|Participant Flow|Toolkit Plus Coaching|"Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.~Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic."
11302892|NCT03063294|OG000|Outcome|Toolkit Only|"Clinics in this arm are given access to an online care coordination toolkit.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes."
11302893|NCT03063294|OG001|Outcome|Toolkit Plus Coaching|"Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.~Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic."
11302894|NCT03063294|EG000|Reported Event|Toolkit Only|"Clinics in this arm are given access to an online care coordination toolkit.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes."
11302895|NCT03063294|EG001|Reported Event|Toolkit Plus Coaching|"Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.~Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.~Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic."
11302896|NCT03063385|BG000|Baseline|Parental Communication Intervention|"The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.~Parental Communication intervention: In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content."
11302897|NCT03063385|BG001|Baseline|Health Promotion Control Condition.|"The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.~Health promotion control condition: In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of homework related to diet and exercise that we will ask parents to complete with their adolescents."
11302898|NCT03063385|BG002|Baseline|Total|Total of all reporting groups
11302899|NCT03063385|FG000|Participant Flow|Parental Communication Intervention|"The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.~Parental Communication intervention: In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content."
11302900|NCT03063385|FG001|Participant Flow|Health Promotion Control Condition.|"The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.~Health promotion control condition: In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of homework related to diet and exercise that we will ask parents to complete with their adolescents."
10971838|NCT00917644|FG000|Participant Flow|Test Drug First|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
10971839|NCT00917644|FG001|Participant Flow|Reference Drug First|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
11302901|NCT03063385|OG000|Outcome|Parental Communication Intervention|"The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.~Parental Communication intervention: In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content."
11302902|NCT03063385|OG001|Outcome|Health Promotion Control Condition.|"The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.~Health promotion control condition: In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of homework related to diet and exercise that we will ask parents to complete with their adolescents."
11302903|NCT03063385|EG000|Reported Event|Parental Communication Intervention|"The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.~Parental Communication intervention: In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content."
11302904|NCT03063385|EG001|Reported Event|Health Promotion Control Condition.|"The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.~Health promotion control condition: In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of homework related to diet and exercise that we will ask parents to complete with their adolescents."
11302905|NCT03063437|BG000|Baseline|Active: Encapsulated Fecal Microbiota Preparation|Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302906|NCT03063437|BG001|Baseline|Placebo: Encapsulated Placebo|Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302907|NCT03063437|BG002|Baseline|Total|Total of all reporting groups
11302908|NCT03063437|FG000|Participant Flow|Active: Encapsulated Fecal Microbiota Preparation|Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302909|NCT03063437|FG001|Participant Flow|Placebo: Encapsulated Placebo|Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302910|NCT03063437|OG000|Outcome|Active: Encapsulated Fecal Microbiota Preparation|Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302911|NCT03063437|OG001|Outcome|Placebo: Encapsulated Placebo|Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
11302912|NCT03063437|EG000|Reported Event|Active: Encapsulated Fecal Microbiota Preparation|Encapsulated fecal microbiota preparation: 30 capsules
10971840|NCT00917644|OG000|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
10971841|NCT00917644|OG001|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
11302913|NCT03063437|EG001|Reported Event|Placebo: Encapsulated Placebo|Encapsulated placebo: 30 capsules
11302914|NCT03063476|BG000|Baseline|Healthy|Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
11302915|NCT03063476|FG000|Participant Flow|Healthy|Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
11302916|NCT03063476|OG000|Outcome|Healthy|Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
11302917|NCT03063476|EG000|Reported Event|Healthy|Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
11302918|NCT03064152|BG000|Baseline|Control|Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
10971842|NCT00917644|EG000|Reported Event|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
10848389|NCT00289783|EG000|Reported Event|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11302919|NCT03064152|BG001|Baseline|ROTEM|Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
11302920|NCT03064152|BG002|Baseline|Total|Total of all reporting groups
11302921|NCT03064152|FG000|Participant Flow|Control|Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
11302922|NCT03064152|FG001|Participant Flow|ROTEM|Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
11302923|NCT03064152|OG000|Outcome|Control|Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
11302924|NCT03064152|OG001|Outcome|ROTEM|"Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.~Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay."
11302925|NCT03064152|EG000|Reported Event|Control|Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
11302926|NCT03064152|EG001|Reported Event|ROTEM|"Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.~Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay."
11302927|NCT03064438|BG000|Baseline|ACU-D1 Ointment|Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
11302928|NCT03064438|BG001|Baseline|ACU-D1 Ointment Vehicle|Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
11302929|NCT03064438|BG002|Baseline|Total|Total of all reporting groups
11302930|NCT03064438|FG000|Participant Flow|ACU-D1 Ointment|Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
11302931|NCT03064438|FG001|Participant Flow|ACU-D1 Ointment Vehicle|Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
11302932|NCT03064438|OG000|Outcome|ACU-D1 Ointment|Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
11302933|NCT03064438|OG001|Outcome|ACU-D1 Ointment Vehicle|Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
11302934|NCT03064438|EG000|Reported Event|ACU-D1 Ointment|Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
11302935|NCT03064438|EG001|Reported Event|ACU-D1 Ointment Vehicle|Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
11302936|NCT03064451|BG000|Baseline|Participants With Persistent Atrial Fibrillation (PsAF)|Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
11302937|NCT03064451|FG000|Participant Flow|Participants With Persistent Atrial Fibrillation (PsAF)|Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
11302938|NCT03064451|OG000|Outcome|Participants With Persistent Atrial Fibrillation (PsAF)|Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
11302939|NCT03064451|EG000|Reported Event|Participants With Persistent Atrial Fibrillation (PsAF)|Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
11302940|NCT03064841|BG000|Baseline|Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)|Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.
11302941|NCT03064841|FG000|Participant Flow|Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)|Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.
11302942|NCT03064841|OG000|Outcome|Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)|Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.
11302943|NCT03064841|EG000|Reported Event|Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)|Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.
10822265|NCT00075725|BG007|Baseline|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
11302944|NCT03065023|BG000|Baseline|Group A: MK-4621 0.2 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302945|NCT03065023|BG001|Baseline|Group A: MK-4621 0.4 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302946|NCT03065023|BG002|Baseline|Group A: MK-4621 0.6 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302947|NCT03065023|BG003|Baseline|Group A: MK-4621 0.8 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302948|NCT03065023|BG004|Baseline|Total|Total of all reporting groups
11302949|NCT03065023|FG000|Participant Flow|Group A: MK-4621 0.2 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via intratumoral (IT)/intralesional (IL) injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
10971843|NCT00917644|EG001|Reported Event|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
10971844|NCT00917735|BG000|Baseline|Green Tea Extract|Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
10971845|NCT00917735|BG001|Baseline|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
11302950|NCT03065023|FG001|Participant Flow|Group A: MK-4621 0.4 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302951|NCT03065023|FG002|Participant Flow|Group A: MK-4621 0.6 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302952|NCT03065023|FG003|Participant Flow|Group A: MK-4621 0.8 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302953|NCT03065023|FG004|Participant Flow|Group B: Liver Lesions|Participants with injectable liver tumors or liver metastases were to receive escalating doses of MK-4621 via IT/IL injection once each week over a period of 4 weeks. Participants were to have been able to continue to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). (Group B was not started for business reasons. Development will continue with new protocol.)
11302954|NCT03065023|OG000|Outcome|Group A: MK-4621 0.2 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
10848390|NCT00289783|EG001|Reported Event|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
11302955|NCT03065023|OG001|Outcome|Group A: MK-4621 0.4 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302956|NCT03065023|OG002|Outcome|Group A: MK-4621 0.6 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302957|NCT03065023|OG003|Outcome|Group A: MK-4621 0.8 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302958|NCT03065023|EG000|Reported Event|Group A: MK-4621 0.2 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302959|NCT03065023|EG001|Reported Event|Group A: MK-4621 0.4 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302960|NCT03065023|EG002|Reported Event|Group A: MK-4621 0.6 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11302961|NCT03065023|EG003|Reported Event|Group A: MK-4621 0.8 mg|Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
11332929|NCT03504189|FG000|Participant Flow|"PregSense™ and Cardiotocopraphy (CTG)"|"PregSense™ WSB then was applied by the authorized study personnel to the maternal abdominal area, not before cleaning the maternal abdomen with a damp cloth, then drying the abdomen. Before initiating the recording session, a valid signal is to be obtained.~An authorized study personnel applied the CTG transducers and confirmed fetal heart rate detection according to the standard of care procedure.~If a valid signal was detected, a 30-minute session initiated, recording both systems simultaneously in a synchronized method (PregSense™ and CTG).~Following the completion of the sessions, the authorized study personnel removed both monitoring systems from the maternal abdomen."
11332930|NCT03504189|OG000|Outcome|"PregSense™ and Cardiotocopraphy (CTG)"|PregSense™ wearable device was applied for maternal-fetal monitoring
11332931|NCT03504189|OG001|Outcome|Cardiotocopraphy (CTG)|Philips FM30 (CTG) was applied for maternal-fetal monitoring
11332932|NCT03504189|OG000|Outcome|PregSense™|PregSense™ wearable device was applied for maternal-fetal monitoring
11332933|NCT03504189|OG001|Outcome|Cardiotocopraphy (CTG)|Philips FM30 Cardiotocopraphy (CTG) was applied for maternal-fetal monitoring
11332934|NCT03504189|OG000|Outcome|"PregSense™ and Cardiotocopraphy (CTG)"|"PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring~PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring~Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring"
11332935|NCT03504189|OG000|Outcome|PregSense™|"PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring~PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring~Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring"
11332936|NCT03504189|EG000|Reported Event|PregSense™|"PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring~PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring~Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring"
11332937|NCT03504839|BG000|Baseline|Intervention|"S-ICD implantation.~Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day"
11332938|NCT03504839|FG000|Participant Flow|Intervention|"S-ICD implantation.~Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day"
11332939|NCT03504839|OG000|Outcome|Intervention|"S-ICD implantation.~Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day"
11332940|NCT03504839|EG000|Reported Event|Intervention|"S-ICD implantation.~Subcutaneous ICD with same day discharge: Receiving a SICD and discharged the same day"
11332941|NCT03504852|BG000|Baseline|Secukinumab 300 mg Every 2 Weeks (Q2W)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
11332942|NCT03504852|BG001|Baseline|Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
11332943|NCT03504852|BG002|Baseline|Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)|2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
11332944|NCT03504852|BG003|Baseline|Total|Total of all reporting groups
11332945|NCT03504852|FG000|Participant Flow|Secukinumab 300 mg Every 2 Weeks (Q2W)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
11332946|NCT03504852|FG001|Participant Flow|Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
10848391|NCT00289848|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
11332947|NCT03504852|FG002|Participant Flow|Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)|2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
11332948|NCT03504852|OG000|Outcome|Secukinumab 300 mg Every 2 Weeks (Q2W)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
11332949|NCT03504852|OG001|Outcome|Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose)|Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.
11302962|NCT03065075|BG000|Baseline|Phenazopyridine|Participant is given Phenazopyridine on morning of postoperative day 1
11302963|NCT03065075|BG001|Baseline|No Phenazopyridine|Participant is not given Phenazopyridine on morning of postoperative day 1
11302964|NCT03065075|BG002|Baseline|Total|Total of all reporting groups
11302965|NCT03065075|FG000|Participant Flow|Phenazopyridine on POD1|"Participant is given Phenazopyridine 200 mg on postoperative day 1~76 subjects were randomized into this arm~4 were removed from the intent-to-treat analysis:~1 had a bowel injury re-operation that precluded performing a void trial~1 intraoperative cystotomy that precluded performing a void trial~2 were using Foley catheters preoperatively, which was part of the exclusion criteria~72 subjects in the intent-to-treat analysis~3 did not receive the intervention:~1 was too nauseous~1 was erroneously missed~1 refused~69 subjects in the as-treated analysis"
11302966|NCT03065075|FG001|Participant Flow|No Intervention on POD1|"Subject is not given Phenazopyridine on postoperative day 1~76 subjects were randomized into this arm~2 were removed from the intent-to-treat analysis:~1 intraoperative cystotomy that precluded performing a void trial~1 had spinal anesthesia, which was part of the exclusion criteria~74 subjects in the intent-to-treat analysis~3 cross-overs were brought in from the intervention arm because they did not receive the medication~77 subjects in the as-treated analysis"
11302967|NCT03065075|OG000|Outcome|Phenazopyridine|Participant is given Phenazopyridine on morning of postoperative day 1
11302968|NCT03065075|OG001|Outcome|No Phenazopyridine|Participant is not given Phenazopyridine on morning of postoperative day 1
11302969|NCT03065075|EG000|Reported Event|Phenazopyridine|"Participant is given Phenazopyridine~Phenazopyridine: Phenazopyridine on morning of postoperative day 1~76 subjects were randomized into this arm~4 were removed from the intent-to-treat analysis:~1 had a bowel injury re-operation that precluded performing a void trial~1 intraoperative cystotomy that precluded performing a void trial~2 were using Foley catheters preoperatively, which was part of the exclusion criteria~72 subjects in the intent-to-treat analysis~3 did not receive the intervention:~1 was too nauseous~1 was erroneously missed~1 refused~69 subjects in the as-treated analysis"
11302970|NCT03065075|EG001|Reported Event|No Phenazopyridine|"Participant is not given Phenazopyridine~76 subjects were randomized into this arm~2 were removed from the intent-to-treat analysis:~1 intraoperative cystotomy that precluded performing a void trial~1 had spinal anesthesia, which was part of the exclusion criteria~74 subjects in the intent-to-treat analysis~3 cross-overs were brought in from the intervention arm because they did not receive the medication~77 subjects in the as-treated analysis"
11302971|NCT03065179|BG000|Baseline|Nivolumab/Ipilimumab Plus SBRT|"Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy~Nivolumab/Ipilimumab: IV immunotherapy~SBRT: SBRT will be delivered in conjunction with immunotherapy"
11302972|NCT03065179|FG000|Participant Flow|Nivolumab/Ipilimumab Plus SBRT|"Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy~Nivolumab/Ipilimumab: IV immunotherapy~SBRT: SBRT will be delivered in conjunction with immunotherapy"
11302973|NCT03065179|OG000|Outcome|Nivolumab/Ipilimumab Plus SBRT|"Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy~Nivolumab/Ipilimumab: IV immunotherapy~SBRT: SBRT will be delivered in conjunction with immunotherapy"
11302974|NCT03065179|EG000|Reported Event|Nivolumab/Ipilimumab Plus SBRT|"Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy~Nivolumab/Ipilimumab: IV immunotherapy~SBRT: SBRT will be delivered in conjunction with immunotherapy"
11302975|NCT03065205|BG000|Baseline|Single Arm|"Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.~Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications"
11302976|NCT03065205|FG000|Participant Flow|Single Arm|"Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.~Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications"
10848392|NCT00289848|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
10848393|NCT00289848|BG002|Baseline|Total|Total of all reporting groups
10971846|NCT00917735|BG002|Baseline|Total|Total of all reporting groups
11302977|NCT03065205|OG000|Outcome|Single Arm|"Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.~Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications"
11302978|NCT03065205|OG000|Outcome|Provider Survey|This is a survey of providers that cared for participants in the study. We had a very low response rate for the exit survey.
11302979|NCT03065205|EG000|Reported Event|Single Arm|"Patients will have adherence monitoring devices placed on their asthma inhalers (both daily and rescue medication). Adherence information will be sent to their PCP, specialist and school nurse monthly. Additionally, the navigator will speak with families every 2 months to discuss adherence data and address barriers.~Propeller Health device + asthma navigator: The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications"
11302980|NCT03065283|BG000|Baseline|Diaphragmatic Release|"The stretching of the peripheral fibers of the diaphragm~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302981|NCT03065283|BG001|Baseline|Diaphragmatic Release Control|"In both placebo techniques, only the light touching of the contacts of the volunteers' skin~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302982|NCT03065283|BG002|Baseline|Total|Total of all reporting groups
11302983|NCT03065283|FG000|Participant Flow|Diaphragmatic Release|"The stretching of the peripheral fibers of the diaphragm~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302984|NCT03065283|FG001|Participant Flow|Diaphragmatic Release Control|"In both placebo techniques, only the light touching of the contacts of the volunteers' skin~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302985|NCT03065283|OG000|Outcome|Diaphragmatic Release|"The stretching of the peripheral fibers of the diaphragm~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302986|NCT03065283|OG001|Outcome|Diaphragmatic Release Control|"In both placebo techniques, only the light touching of the contacts of the volunteers' skin~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302987|NCT03065283|EG000|Reported Event|Diaphragmatic Release|"The stretching of the peripheral fibers of the diaphragm~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302988|NCT03065283|EG001|Reported Event|Diaphragmatic Release Control|"In both placebo techniques, only the light touching of the contacts of the volunteers' skin~Diaphragm lift: The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice~Relaxation of the diaphragm pillars: Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute"
11302989|NCT03065400|BG000|Baseline|Pembolizumab|200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks
11302990|NCT03065400|FG000|Participant Flow|Pembolizumab|200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks
10848394|NCT00289848|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
10848395|NCT00289848|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
11302991|NCT03065400|OG000|Outcome|Pembolizumab|200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks
11302992|NCT03065400|EG000|Reported Event|Pembolizumab|200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks
11302993|NCT03065530|BG000|Baseline|Placebo|"The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section."
11302994|NCT03065530|BG001|Baseline|Dexmedetomidine 0.03ug/kg/h|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11302995|NCT03065530|BG002|Baseline|Dexmedetomidine 0.05ug/kg/h|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11302996|NCT03065530|BG003|Baseline|Dexmedetomidine 0.08ug/kg/h|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11302997|NCT03065530|BG004|Baseline|Total|Total of all reporting groups
11302998|NCT03065530|FG000|Participant Flow|Group C|"The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section."
11302999|NCT03065530|FG001|Participant Flow|Group D1|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303000|NCT03065530|FG002|Participant Flow|Group D2|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11303001|NCT03065530|FG003|Participant Flow|Group D3|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11303002|NCT03065530|OG000|Outcome|Group C|"The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section."
11303003|NCT03065530|OG001|Outcome|Group D1|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303004|NCT03065530|OG002|Outcome|Group D2|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11303005|NCT03065530|OG003|Outcome|Group D3|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11303006|NCT03065530|OG000|Outcome|Group D1|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303007|NCT03065530|OG001|Outcome|Group D2|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11303008|NCT03065530|OG002|Outcome|Group D3|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11303009|NCT03065530|OG000|Outcome|Control Group|"The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section."
11303010|NCT03065530|OG001|Outcome|Dexmedetomidine 0.03ug/kg/h Group|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303011|NCT03065530|OG002|Outcome|Dexmedetomidine 0.05ug/kg/h Group|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11303012|NCT03065530|OG003|Outcome|Dexmedetomidine 0.08ug/kg/h Group|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11303013|NCT03065530|OG000|Outcome|Group C|"This group will receive 30 ml 0.9% sodium chloride in 30 min. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303014|NCT03065530|EG000|Reported Event|Group C|"The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section."
11303015|NCT03065530|EG001|Reported Event|Group D1|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section."
11303016|NCT03065530|EG002|Reported Event|Group D2|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section."
11303017|NCT03065530|EG003|Reported Event|Group D3|"This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.~Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.~Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section."
11303018|NCT03065647|BG000|Baseline|Standard Care|Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
10848396|NCT00289848|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
10848397|NCT00289848|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
11303019|NCT03065647|BG001|Baseline|Expedited Transport|"Intervention: Expedited Transport with Mechanical CPR.~After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).~Expedited Transport With Mechanical CPR: Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR."
11303020|NCT03065647|BG002|Baseline|Total|Total of all reporting groups
11303021|NCT03065647|FG000|Participant Flow|Standard Care|Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
11303022|NCT03065647|FG001|Participant Flow|Expedited Transport|"Intervention: Expedited Transport with Mechanical CPR.~After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).~Expedited Transport With Mechanical CPR: Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR."
11303023|NCT03065647|OG000|Outcome|Standard Care|Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
11303024|NCT03065647|OG001|Outcome|Expedited Transport|"Intervention: Expedited Transport with Mechanical CPR.~After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).~Expedited Transport With Mechanical CPR: Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR."
11303025|NCT03065647|EG000|Reported Event|Standard Care|Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
11303026|NCT03065647|EG001|Reported Event|Expedited Transport|"Intervention: Expedited Transport with Mechanical CPR.~After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).~Expedited Transport With Mechanical CPR: Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR."
11303027|NCT03066102|BG000|Baseline|Fatigued Group|the only group in this study, and every subjects took the fatigued task
11303028|NCT03066102|FG000|Participant Flow|Fatigued Group|Subjects held in a modify pushup plus position. Like an all four position, subjects hold with right arm with elbow flexion and full shoulder protraction. Male subjects had to hold three minutes for ten repetitions, and female subjects were two minutes for five repetitions. There was thirty second rest between repetitions. The end of fatigue task was: subjects finished all the repetition, or could not do one more repetition. Female subjects could do more than five repetitions if they felt ok, and the maximum repetitions were ten. The muscle activation of upper trapezius, lower trapezius, and serratus would record for analysis of median frequency. As long as finished fatigue task, the post measurements would start.
11303029|NCT03066102|OG000|Outcome|Fatigued Group|Subjects held in a modify pushup plus position. Like an all four position, subjects hold with right arm with elbow flexion and full shoulder protraction. Male subjects had to hold three minutes for ten repetitions, and female subjects were two minutes for five repetitions. There was thirty second rest between repetitions. The end of fatigue task was: subjects finished all the repetition, or could not do one more repetition. Female subjects could do more than five repetitions if they felt ok, and the maximum repetitions were ten. The muscle activation of upper trapezius, lower trapezius, and serratus would record for analysis of median frequency. As long as finished fatigue task, the post measurements would start.
11303030|NCT03066102|EG000|Reported Event|Fatigued Group|Subjects held in a modify pushup plus position. Like an all four position, subjects hold with right arm with elbow flexion and full shoulder protraction. Male subjects had to hold three minutes for ten repetitions, and female subjects were two minutes for five repetitions. There was thirty second rest between repetitions. The end of fatigue task was: subjects finished all the repetition, or could not do one more repetition. Female subjects could do more than five repetitions if they felt ok, and the maximum repetitions were ten. The muscle activation of upper trapezius, lower trapezius, and serratus would record for analysis of median frequency. As long as finished fatigue task, the post measurements would start.
11303031|NCT03066193|BG000|Baseline|Dronabinol and Palmitoylethanolamide|"All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. Participants will be receiving PEA concomitantly.~All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.~Dronabinol: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks.~Palmotoyletahnolamide: Participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks."
11303032|NCT03066193|FG000|Participant Flow|Dronabinol and Palmitoylethanolamide|All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants received two 400mg tablets of PEA daily for the same 12 weeks that they received the Dronabinol.
11303033|NCT03066193|OG000|Outcome|Dronabinol and Palmitoylethanolamide|"All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.~Dronabinol: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks.~Palmotoyletahnolamide: Participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks."
11303034|NCT03066193|EG000|Reported Event|Dronabinol and Palmitoylethanolamide|"All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.~Dronabinol and Palmitoylethanolamide: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks."
11303035|NCT03066609|BG000|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c.
11303036|NCT03066609|BG001|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c.
11303037|NCT03066609|BG002|Baseline|Placebo|Placebo
11303038|NCT03066609|BG003|Baseline|Total|Total of all reporting groups
11303039|NCT03066609|FG000|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c.
11303040|NCT03066609|FG001|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c.
11303041|NCT03066609|FG002|Participant Flow|Placebo|Placebo
11303042|NCT03066609|FG003|Participant Flow|Placebo - Secukinumab 300mg|patients switched to AIN457 at week 12
10848398|NCT00289848|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
11303043|NCT03066609|OG000|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c.
11303044|NCT03066609|OG001|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c.
11303045|NCT03066609|OG002|Outcome|Placebo|Placebo
11303046|NCT03066609|OG003|Outcome|Placebo - AIN457 300 mg|patients switched to AIN457 at week 12
11303047|NCT03066609|EG000|Reported Event|AIN457 150 mg|AIN457 150 mg
11303048|NCT03066609|EG001|Reported Event|AIN457 300 mg|AIN457 300 mg
11303049|NCT03066609|EG002|Reported Event|Any AIN457 300 mg|Any AIN457 300 mg
11303050|NCT03066609|EG003|Reported Event|Any AIN457 Dose|Any AIN457 dose
11303051|NCT03066609|EG004|Reported Event|Placebo|Placebo
11303052|NCT03066778|BG000|Baseline|Pembrolizumab + Etoposide|During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303053|NCT03066778|BG001|Baseline|Placebo + Etoposide|During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303054|NCT03066778|BG002|Baseline|Total|Total of all reporting groups
11303055|NCT03066778|FG000|Participant Flow|Pembrolizumab + Etoposide|During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303056|NCT03066778|FG001|Participant Flow|Placebo + Etoposide|During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303057|NCT03066778|OG000|Outcome|Pembrolizumab + Etoposide|During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303058|NCT03066778|OG001|Outcome|Placebo + Etoposide|During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303059|NCT03066778|EG000|Reported Event|Pembrolizumab + Etoposide|During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303060|NCT03066778|EG001|Reported Event|Placebo + Etoposide|During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
11303061|NCT03066804|BG000|Baseline|Sacubitril/Valsartan (LCZ696)|All patients who fulfilled the inclusion/exclusion criteria were stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi.
11303062|NCT03066804|BG001|Baseline|Individualized Medical Therapy (IMT) Comparator|Patients randomized to the comparator arm received either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).
11303063|NCT03066804|BG002|Baseline|Total|Total of all reporting groups
10848399|NCT00289848|EG001|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
11303064|NCT03066804|FG000|Participant Flow|Sacubitril/Valsartan (LCZ696)|All patients who fulfilled the inclusion/exclusion criteria were stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi.
11303065|NCT03066804|FG001|Participant Flow|Individualized Medical Therapy (IMT) Comparator|Patients randomized to the comparator arm received either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).
11303066|NCT03066804|OG000|Outcome|Sacubitril/Valsartan (LCZ696)|All patients who fulfilled the inclusion/exclusion criteria were stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi.
11303067|NCT03066804|OG001|Outcome|Individualized Medical Therapy (IMT) Comparator|Patients randomized to the comparator arm received either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).
11303068|NCT03066804|EG000|Reported Event|Sacubitril/Valsartan (LCZ696)|All patients who fulfilled the inclusion/exclusion criteria were stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi.
11303069|NCT03066804|EG001|Reported Event|Individualized Medical Therapy (IMT)|Patients randomized to the comparator arm received either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).
11303070|NCT03066804|EG002|Reported Event|Total|Total
11303071|NCT03066830|BG000|Baseline|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303072|NCT03066830|BG001|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303073|NCT03066830|BG002|Baseline|Total|Total of all reporting groups
10848400|NCT00289900|BG000|Baseline|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
11303074|NCT03066830|FG000|Participant Flow|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303075|NCT03066830|FG001|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303076|NCT03066830|OG000|Outcome|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303077|NCT03066830|OG001|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303078|NCT03066830|OG001|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 milligrams (mg), orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
11303079|NCT03066830|EG000|Reported Event|Placebo|Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. One participant randomized to Placebo who was dosed with Sotagliflozin 400 mg treatment during the study is included in the Sotagliflozin 400 mg arm in the safety population.
11303080|NCT03066830|EG001|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 milligrams (mg), orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. One participant randomized to Placebo who was dosed with Sotagliflozin 400 mg treatment during the study is included in the Sotagliflozin 400 mg arm in the safety population.
11303081|NCT03066947|BG000|Baseline|SV-BR-1-GM Monotherapy|"Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation~SV-BR-1-GM: See above~Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells~Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response"
11303082|NCT03066947|FG000|Participant Flow|SV-BR-1-GM Monotherapy|"Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation~SV-BR-1-GM: See above~Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells~Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response"
11303083|NCT03066947|OG000|Outcome|SV-BR-1-GM Monotherapy|"Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation~SV-BR-1-GM: See above~Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells~Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response"
11303084|NCT03066947|OG000|Outcome|Median Duration|Median duration of adverse events
11303085|NCT03066947|EG000|Reported Event|SV-BR-1-GM Monotherapy|"Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation~SV-BR-1-GM: See above~Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells~Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response"
11303086|NCT03066999|BG000|Baseline|Cystoscopy|will have catheter placement using the cystoscopy method
11303087|NCT03066999|BG001|Baseline|DirectVision|will have catheter placement using DirectVision
11303088|NCT03066999|BG002|Baseline|Total|Total of all reporting groups
11303089|NCT03066999|FG000|Participant Flow|Cystoscopy|Patient will have catheter placement using the cystoscopy method
10848401|NCT00289900|BG001|Baseline|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
11303090|NCT03066999|FG001|Participant Flow|DirectVision|Patient will have catheter placement using DirectVision.
11303091|NCT03066999|OG000|Outcome|Cystoscopy|will have catheter placement using the cystoscope
11303092|NCT03066999|OG001|Outcome|DirectVision|will have catheter placement using DirectVision.
11303093|NCT03066999|OG000|Outcome|Cystoscopy|will have catheter placement using the cystoscopy method
11303094|NCT03066999|EG000|Reported Event|Cystoscopy|will have catheter placement using the cystoscopy method
11303095|NCT03066999|EG001|Reported Event|DirectVision|will have catheter placement using DirectVision.
11303096|NCT03067311|BG000|Baseline|I-CAT|"A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.~I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)."
11303097|NCT03067311|BG001|Baseline|Treatment as Usual|"Usual treatment provided at the UNC OASIS Clinics by trained clinicians.~Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic."
11303098|NCT03067311|BG002|Baseline|Total|Total of all reporting groups
11303099|NCT03067311|FG000|Participant Flow|I-CAT|"A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.~I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)."
11303100|NCT03067311|FG001|Participant Flow|Treatment as Usual|"Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) OASIS Clinics by trained clinicians.~Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic."
11303101|NCT03067311|OG000|Outcome|I-CAT|"A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.~I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)."
11303102|NCT03067311|OG001|Outcome|Treatment as Usual|"Usual treatment provided at the UNC OASIS Clinics by trained clinicians.~Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic."
11303103|NCT03067311|EG000|Reported Event|I-CAT|"A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.~I-CAT: I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)."
11303104|NCT03067311|EG001|Reported Event|Treatment as Usual|"Usual treatment provided at the UNC OASIS Clinics by trained clinicians.~Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic."
11303105|NCT03067441|BG000|Baseline|Placebo; Bempedoic Acid|In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).
10848402|NCT00289900|BG002|Baseline|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
11332950|NCT03504852|OG001|Outcome|Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
11332951|NCT03504852|OG002|Outcome|Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)|2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
11332952|NCT03504852|EG000|Reported Event|Secukinumab 300 mg Every 2 Weeks (Q2W)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
11303106|NCT03067441|BG001|Baseline|Bempedoic Acid; Bempedoic Acid|In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303107|NCT03067441|BG002|Baseline|Total|Total of all reporting groups
11303108|NCT03067441|FG000|Participant Flow|Placebo; Bempedoic Acid|In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).
11303109|NCT03067441|FG001|Participant Flow|Bempedoic Acid; Bempedoic Acid|In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303110|NCT03067441|OG000|Outcome|Placebo; Bempedoic Acid|In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).
11303111|NCT03067441|OG001|Outcome|Bempedoic Acid; Bempedoic Acid|In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303112|NCT03067441|OG002|Outcome|OLE Bempedoic Acid|In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303113|NCT03067441|OG000|Outcome|Placebo; Bempedoic Acid|In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303114|NCT03067441|EG000|Reported Event|Placebo; Bempedoic Acid|In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).
11303115|NCT03067441|EG001|Reported Event|Bempedoic Acid; Bempedoic Acid|In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303116|NCT03067441|EG002|Reported Event|OLE Bempedoic Acid|In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
11303117|NCT03067506|BG000|Baseline|Participants With Major Depressive Disorder (MDD)|Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
11303118|NCT03067506|FG000|Participant Flow|Participants With Major Depressive Disorder (MDD)|Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
11303119|NCT03067506|OG000|Outcome|Participants With Major Depressive Disorder (MDD)|Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
11303120|NCT03067506|EG000|Reported Event|Participants With Major Depressive Disorder (MDD)|Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
11303121|NCT03067948|BG000|Baseline|Intervention - Positive Screen Shared|In the intervention, participants were given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens will be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient had chosen to discuss with the provider will be specified. The provider received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
11303122|NCT03067948|FG000|Participant Flow|Intervention - Positive Screen Shared|Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the Patient Reported Outcomes (PROs) result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
11303123|NCT03067948|OG000|Outcome|Intervention - Positive Screen Shared|Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
11303124|NCT03067948|EG000|Reported Event|Intervention - Positive Screen Shared|Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
11303125|NCT03067987|BG000|Baseline|720 Shockwave Therapy|5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
11303126|NCT03067987|BG001|Baseline|600 Shockwave Therapy|Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
11303127|NCT03067987|BG002|Baseline|Total|Total of all reporting groups
11303128|NCT03067987|FG000|Participant Flow|720 Shockwave Therapy|5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
11303129|NCT03067987|FG001|Participant Flow|600 Shockwave Therapy|Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
11303130|NCT03067987|OG000|Outcome|720 Shockwave Therapy|5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
11303131|NCT03067987|OG001|Outcome|600 Shockwave Therapy|Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
11303132|NCT03067987|EG000|Reported Event|720 Shockwave Therapy|5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
11303133|NCT03067987|EG001|Reported Event|600 Shockwave Therapy|Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
11303134|NCT03068091|BG000|Baseline|Pulmonary Assessment|"All participants will undergo a Chest CT scan and pulmonary function testing~Chest CT: Inspiration and expiration chest CT~Pulmonary Function Testing: Measure lung function"
11303135|NCT03068091|FG000|Participant Flow|Pulmonary Assessment|"All participants will undergo a Chest CT scan and pulmonary function testing~Chest CT: Inspiration and expiration chest CT~Pulmonary Function Testing: Measure lung function"
11303136|NCT03068091|OG000|Outcome|Pulmonary Assessment|"All participants underwent a Chest CT scan and pulmonary function testing~Chest CT: Inspiration and expiration chest CT~Pulmonary Function Testing: Measure lung function"
11303137|NCT03068091|OG000|Outcome|Pulmonary Assessment|"All participants will undergo a Chest CT scan and pulmonary function testing~Chest CT: Inspiration and expiration chest CT~Pulmonary Function Testing: Measure lung function"
11303138|NCT03068091|EG000|Reported Event|Pulmonary Assessment|"All participants will undergo a Chest CT scan and pulmonary function testing~Chest CT: Inspiration and expiration chest CT~Pulmonary Function Testing: Measure lung function"
11303139|NCT03068312|BG000|Baseline|Sequence 1: First IVA Then Placebo|Participants received IVA 150 mg q12h for 8 weeks in treatment period 1 followed by placebo matched to IVA for 8 weeks in treatment period 2. A washout period of 8 weeks was maintained between the 2 treatment periods.
11303140|NCT03068312|BG001|Baseline|Sequence 2: First Placebo Then IVA|Participants received placebo matched to IVA for 8 weeks in treatment period 1 followed by IVA 150 mg q12h for 8 weeks in treatment period 2. A washout period of 8 weeks was maintained between the 2 treatment periods.
11303141|NCT03068312|BG002|Baseline|Total|Total of all reporting groups
11303142|NCT03068312|FG000|Participant Flow|Sequence 1: First Ivacaftor (IVA) Then Placebo|Participants received IVA 150 milligram (mg) every 12 hours (q12h) for 8 weeks in treatment period 1 followed by placebo matched to IVA for 8 weeks in treatment period 2. A washout period of 8 weeks was maintained between the 2 treatment periods.
11303143|NCT03068312|FG001|Participant Flow|Sequence 2: First Placebo Then IVA|Participants received placebo matched to IVA for 8 weeks in treatment period 1 followed by IVA 150 mg q12h for 8 weeks in treatment period 2. A washout period of 8 weeks was maintained between the 2 treatment periods.
11303144|NCT03068312|OG000|Outcome|Placebo|All participants who received placebo matched to IVA for 8 weeks in treatment period 1 or 2.
10848403|NCT00289900|BG003|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
11303145|NCT03068312|OG001|Outcome|Ivacaftor|All participants who received IVA for 8 weeks in treatment period 1 or 2.
11303146|NCT03068312|EG000|Reported Event|Placebo|All participants who received placebo matched to IVA for 8 weeks in treatment period 1 or 2.
11303147|NCT03068312|EG001|Reported Event|Ivacaftor|All participants who received IVA for 8 weeks in treatment period 1 or 2.
10848404|NCT00289900|BG004|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
10848405|NCT00289900|BG005|Baseline|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
10848406|NCT00289900|BG006|Baseline|Total|Total of all reporting groups
11303148|NCT03068455|BG000|Baseline|Arm A: Nivo + Ipi|Arm A: nivolumab 240 mg IV Q2 weeks plus ipilimumab 1 mg/kg IV Q6 weeks (for 1 year of study drug treatment)
11303149|NCT03068455|BG001|Baseline|Arm B: Nivo|Arm B: nivolumab 480 mg IV Q4 weeks (for 1 year of study drug treatment) with nivolumab placebo on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, & 47 and ipilimumab placebo on Weeks 1, 7, 13, 19, 25, 31, 37, 43, & 49
11303150|NCT03068455|BG002|Baseline|Total|Total of all reporting groups
11303151|NCT03068455|FG000|Participant Flow|Arm A: Nivo + Ipi|Arm A: nivolumab 240 mg IV Q2 weeks plus ipilimumab 1 mg/kg IV Q6 weeks (for 1 year of study drug treatment)
11303152|NCT03068455|FG001|Participant Flow|Arm B: Nivo|Arm B: nivolumab 480 mg IV Q4 weeks (for 1 year of study drug treatment) with nivolumab placebo on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, & 47 and ipilimumab placebo on Weeks 1, 7, 13, 19, 25, 31, 37, 43, & 49
11303153|NCT03068455|OG000|Outcome|Arm A: Nivo + Ipi|Arm A: nivolumab 240 mg IV Q2 weeks plus ipilimumab 1 mg/kg IV Q6 weeks (for 1 year of study drug treatment)
11303154|NCT03068455|OG001|Outcome|Arm B: Nivo|Arm B: nivolumab 480 mg IV Q4 weeks (for 1 year of study drug treatment) with nivolumab placebo on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, & 47 and ipilimumab placebo on Weeks 1, 7, 13, 19, 25, 31, 37, 43, & 49
11303155|NCT03068455|EG000|Reported Event|Arm A: Nivo + Ipi|Arm A: nivolumab 240 mg IV Q2 weeks plus ipilimumab 1 mg/kg IV Q6 weeks (for 1 year of study drug treatment)
11303156|NCT03068455|EG001|Reported Event|Arm B: Nivo|Arm B: nivolumab 480 mg IV Q4 weeks (for 1 year of study drug treatment) with nivolumab placebo on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, & 47 and ipilimumab placebo on Weeks 1, 7, 13, 19, 25, 31, 37, 43, & 49
11303157|NCT03068468|BG000|Baseline|Placebo (PC Period)|Participants assigned to BIIB092 matching placebo intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo.
11303158|NCT03068468|BG001|Baseline|BIIB092 2000 mg (PC Period)|Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 milligrams (mg) IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period.
11303159|NCT03068468|BG002|Baseline|Total|Total of all reporting groups
11303160|NCT03068468|FG000|Participant Flow|Placebo (PC Period)|Participants assigned to BIIB092 matching placebo intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo.
10822266|NCT00075725|BG008|Baseline|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11303161|NCT03068468|FG001|Participant Flow|BIIB092 2000 mg (PC Period)|Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 milligrams (mg) IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period.
11303162|NCT03068468|FG002|Participant Flow|BIIB092 Late Start (OLE Period)|Late start subjects received only placebo in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period.
11303163|NCT03068468|FG003|Participant Flow|BIIB092 Early Start (OLE Period)|Early start subjects are those who received BIIB092 2000 mg in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period.
11303164|NCT03068468|OG000|Outcome|Placebo (PC Period)|Participants assigned to BIIB092 matching placebo intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo.
11303165|NCT03068468|OG001|Outcome|BIIB092 2000 mg (PC Period)|Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 milligrams (mg) IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period.
11303166|NCT03068468|EG000|Reported Event|Placebo (Placebo Controlled Period)|Participants assigned to BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo.
11303167|NCT03068468|EG001|Reported Event|BIIB092 2000 mg (Placebo Controlled Period)|Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 mg IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period.
11303168|NCT03068468|EG002|Reported Event|BIIB092 Late Start (Open-label Extension Period)|Late start participants received only placebo in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period.
11303169|NCT03068468|EG003|Reported Event|BIIB092 Early Start (Open-label Extension Period)|Early start participants are those who received BIIB092 2000 mg in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period.
11303170|NCT03068611|BG000|Baseline|Standard Web-based Smoking Cessation|"A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.~Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303171|NCT03068611|BG001|Baseline|Alcohol-focused Web-Based Smoking Cessation|"A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.~Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303172|NCT03068611|BG002|Baseline|Total|Total of all reporting groups
11303173|NCT03068611|FG000|Participant Flow|Standard Web-based Smoking Cessation|"A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.~Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303174|NCT03068611|FG001|Participant Flow|Alcohol-focused Web-Based Smoking Cessation|"A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.~Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303175|NCT03068611|OG000|Outcome|Standard Web-based Smoking Cessation|"A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.~Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303176|NCT03068611|OG001|Outcome|Alcohol-focused Web-Based Smoking Cessation|"A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.~Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303177|NCT03068611|EG000|Reported Event|Standard Web-based Smoking Cessation|"A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.~Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303178|NCT03068611|EG001|Reported Event|Alcohol-focused Web-Based Smoking Cessation|"A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.~Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish."
11303179|NCT03068754|BG000|Baseline|Arm A: RTP Acthar Gel|"Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar Gel), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39."
11303180|NCT03068754|BG001|Baseline|Arm B: RTP Placebo|"Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (matching Placebo), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39."
11303181|NCT03068754|BG002|Baseline|Total|Total of all reporting groups
11303182|NCT03068754|FG000|Participant Flow|Arm A: Randomized Treatment Period (RTP) Acthar Gel|"Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar Gel), daily for up to 36 weeks.~Those who do not continue into the extension period had 3 weeks of tapering off the drug, ending their participation by Week 39."
11303183|NCT03068754|FG001|Participant Flow|Arm B: RTP Placebo|"Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (matching Placebo), daily for up to 36 weeks.~Those who do not continue into the extension period had 3 weeks of simulated tapering, ending their participation by Week 39."
11303184|NCT03068754|FG002|Participant Flow|Arm C: Open Label Extension Period (OLE) Acthar Gel-Acthar Gel|Participants who received Acthar Gel during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar Gel, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303185|NCT03068754|FG003|Participant Flow|Arm D: OLE Placebo-Acthar Gel|Participants who received Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303186|NCT03068754|OG000|Outcome|Arm A: RTP Acthar Gel|"Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar Gel), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39."
11303187|NCT03068754|OG001|Outcome|Arm B: RTP Placebo|"Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (matching Placebo), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39."
10848407|NCT00289900|FG000|Participant Flow|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
10848408|NCT00289900|FG001|Participant Flow|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
11303188|NCT03068754|OG000|Outcome|Arm C: OLE Acthar Gel-Acthar Gel|Participants who receive Acthar Gel during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar Gel, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303189|NCT03068754|OG001|Outcome|Arm D: OLE Placebo-Acthar Gel|Participants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303190|NCT03068754|EG000|Reported Event|Arm A: RTP Acthar Gel|"Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar Gel), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39."
11303191|NCT03068754|EG001|Reported Event|Arm B: RTP Placebo|"Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (matching Placebo), daily for up to 36 weeks.~Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39."
11303192|NCT03068754|EG002|Reported Event|Arm C: OLE Acthar Gel-Acthar Gel|Participants who receive Acthar Gel during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar Gel, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303193|NCT03068754|EG003|Reported Event|Arm D: OLE Placebo-Acthar Gel|Participants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
11303194|NCT03068767|BG000|Baseline|Vitamin D Group|"Patients receiving vitamin D supplement (2000 IU/day) for 2 months~Vitamin D"
11303195|NCT03068767|BG001|Baseline|Control Group|Patients without receiving vitamin D supplement
11303196|NCT03068767|BG002|Baseline|Total|Total of all reporting groups
11303197|NCT03068767|FG000|Participant Flow|Vitamin D Group|"Patients receiving vitamin D supplement (2000 IU/day) for 2 months~Vitamin D"
11303198|NCT03068767|FG001|Participant Flow|Control Group|Patients without receiving vitamin D supplement
11303199|NCT03068767|OG000|Outcome|Vitamin D Group|"Patients receiving vitamin D supplement (2000 IU/day) for 2 months~Vitamin D"
11303200|NCT03068767|OG001|Outcome|Control Group|Patients without receiving vitamin D supplement
11303201|NCT03068767|EG000|Reported Event|Vitamin D Group|"Patients receiving vitamin D supplement (2000 IU/day) for 2 months~Vitamin D~No serious adverse events noted."
10848409|NCT00289900|FG002|Participant Flow|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
10848410|NCT00289900|FG003|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
10848411|NCT00289900|FG004|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
11303202|NCT03068767|EG001|Reported Event|Control Group|"Patients without receiving vitamin D supplement~No serious adverse events noted."
11303203|NCT03068897|BG000|Baseline|Metaxalone|"Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Metaxalone: Metaxalone 400-800mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303204|NCT03068897|BG001|Baseline|Tizanidine|"Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Tizanidine: Tizanidine 2-4mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303205|NCT03068897|BG002|Baseline|Baclofen|"Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Baclofen: Baclofen 10-20mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303206|NCT03068897|BG003|Baseline|Placebo|"Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303207|NCT03068897|BG004|Baseline|Total|Total of all reporting groups
11303208|NCT03068897|FG000|Participant Flow|Metaxalone|"Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Metaxalone: Metaxalone 400-800mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11332953|NCT03504852|EG001|Reported Event|Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)|2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
11303209|NCT03068897|FG001|Participant Flow|Tizanidine|"Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Tizanidine: Tizanidine 2-4mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303210|NCT03068897|FG002|Participant Flow|Baclofen|"Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Baclofen: Baclofen 10-20mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
10848412|NCT00289900|FG005|Participant Flow|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
10848413|NCT00289900|OG000|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
11303211|NCT03068897|FG003|Participant Flow|Placebo|"Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303212|NCT03068897|OG000|Outcome|Metaxalone|"Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Metaxalone: Metaxalone 400-800mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303213|NCT03068897|OG001|Outcome|Tizanidine|"Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Tizanidine: Tizanidine 2-4mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303214|NCT03068897|OG002|Outcome|Baclofen|"Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Baclofen: Baclofen 10-20mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303215|NCT03068897|OG003|Outcome|Placebo|"Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303216|NCT03068897|EG000|Reported Event|Metaxalone|"Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Metaxalone: Metaxalone 400-800mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303217|NCT03068897|EG001|Reported Event|Tizanidine|"Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Tizanidine: Tizanidine 2-4mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303218|NCT03068897|EG002|Reported Event|Baclofen|"Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Baclofen: Baclofen 10-20mg~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303219|NCT03068897|EG003|Reported Event|Placebo|"Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.~All participants receive a brief educational intervention.~Ibuprofen 600 mg: Ibuprofen~Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions."
11303220|NCT03068949|BG000|Baseline|FluBlok|"FluBlok 0.5 mL given IM X1~FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly"
11303221|NCT03068949|BG001|Baseline|Fluzone|"Fluzone 0.5 mL given IM X1~Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303222|NCT03068949|BG002|Baseline|FluCelVax|"FluCelVax 0.5 mL given IM X 1~FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303223|NCT03068949|BG003|Baseline|Fluzone HD|"Fluzone HD 0.5 mL given IM X1~Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly"
11303224|NCT03068949|BG004|Baseline|Total|Total of all reporting groups
11303225|NCT03068949|FG000|Participant Flow|FluBlok|"FluBlok 0.5 mL given IM X1~FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly"
11303226|NCT03068949|FG001|Participant Flow|Fluzone|"Fluzone 0.5 mL given IM X1~Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
10848414|NCT00289900|OG001|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
10848415|NCT00289900|OG002|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
10848416|NCT00289900|OG003|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
10848417|NCT00289900|OG004|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
11303227|NCT03068949|FG002|Participant Flow|FluCelVax|"FluCelVax 0.5 mL given IM X 1~FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303228|NCT03068949|FG003|Participant Flow|Fluzone HD|"Fluzone HD 0.5 mL given IM X1~Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly"
11303229|NCT03068949|OG000|Outcome|FluBlok|"FluBlok 0.5 mL given IM X1~FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly"
11303230|NCT03068949|OG001|Outcome|Fluzone|"Fluzone 0.5 mL given IM X1~Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303231|NCT03068949|OG002|Outcome|FluCelVax|"FluCelVax 0.5 mL given IM X 1~FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303232|NCT03068949|OG003|Outcome|Fluzone HD|"Fluzone HD 0.5 mL given IM X1~Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly"
11303233|NCT03068949|EG000|Reported Event|FluBlok|"FluBlok 0.5 mL given IM X1~FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly"
11303234|NCT03068949|EG001|Reported Event|Fluzone|"Fluzone 0.5 mL given IM X1~Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303235|NCT03068949|EG002|Reported Event|FluCelVax|"FluCelVax 0.5 mL given IM X 1~FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly"
11303236|NCT03068949|EG003|Reported Event|Fluzone HD|"Fluzone HD 0.5 mL given IM X1~Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly"
11303237|NCT03069313|BG000|Baseline|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
11303238|NCT03069313|FG000|Participant Flow|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
11303239|NCT03069313|OG000|Outcome|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
11303240|NCT03069313|EG000|Reported Event|Arm I|"Oral Vitamin B12~Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)"
11303241|NCT03069352|BG000|Baseline|Placebo + Low Dose Cytarabine (LDAC)|Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
11303242|NCT03069352|BG001|Baseline|Venetoclax + Low Dose Cytarabine (LDAC)|Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
11303243|NCT03069352|BG002|Baseline|Total|Total of all reporting groups
11303244|NCT03069352|FG000|Participant Flow|Placebo + Low Dose Cytarabine (LDAC)|"Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.~Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met."
11303245|NCT03069352|FG001|Participant Flow|Venetoclax + Low Dose Cytarabine (LDAC)|"Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.~Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met."
10848418|NCT00289900|OG005|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
11303246|NCT03069352|OG000|Outcome|Placebo + Low Dose Cytarabine (LDAC)|Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
11303247|NCT03069352|OG001|Outcome|Venetoclax + Low Dose Cytarabine (LDAC)|Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
10848419|NCT00289900|OG000|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
11303248|NCT03069352|EG000|Reported Event|Placebo + Low Dose Cytarabine (LDAC)|Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
11303249|NCT03069352|EG001|Reported Event|Venetoclax + Low Dose Cytarabine (LDAC)|Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
11303250|NCT03069365|BG000|Baseline|GLE/PIB for 8, 12, or 16 Weeks|Glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food
11303251|NCT03069365|FG000|Participant Flow|GLE/PIB for 8, 12, or 16 Weeks|Glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food
11303252|NCT03069365|OG000|Outcome|GLE/PIB for 8, 12, or 16 Weeks|Glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food
11303253|NCT03069365|EG000|Reported Event|GLE/PIB for 8, 12, or 16 Weeks|Glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food
11303254|NCT03069482|BG000|Baseline|Learn to Quit|A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303255|NCT03069482|BG001|Baseline|NCI QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303256|NCT03069482|BG002|Baseline|Total|Total of all reporting groups
11303257|NCT03069482|FG000|Participant Flow|Learn to Quit|A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303258|NCT03069482|FG001|Participant Flow|NCI QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303259|NCT03069482|OG000|Outcome|Learn to Quit|A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303260|NCT03069482|OG001|Outcome|NCI QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303261|NCT03069482|OG000|Outcome|All Consented Participants|All participants consented to the study prior to eligibility determination.
11303262|NCT03069482|OG000|Outcome|Total Patients in Database|The total amount of patients who could have potentially contacted us or that we could have approached to participate in the study.
11303263|NCT03069482|OG000|Outcome|QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303264|NCT03069482|EG000|Reported Event|Learn to Quit|A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303265|NCT03069482|EG001|Reported Event|NCI QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
11303266|NCT03069677|BG000|Baseline|Music Group|"research-selected music~music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff"
11303267|NCT03069677|BG001|Baseline|Midazolam Group|"IV midazolam (1mg to 2mg max)~Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed"
11303268|NCT03069677|BG002|Baseline|Total|Total of all reporting groups
11303269|NCT03069677|FG000|Participant Flow|Music Group|"research-selected music~music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff"
11303270|NCT03069677|FG001|Participant Flow|Midazolam Group|"IV midazolam (1mg to 2mg max)~Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed"
11303271|NCT03069677|OG000|Outcome|Music Group|"research-selected music~music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff"
11303272|NCT03069677|OG001|Outcome|Midazolam Group|"IV midazolam (1mg to 2mg max)~Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed"
11303273|NCT03069677|EG000|Reported Event|Music Group|"research-selected music~music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff~there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group"
11303274|NCT03069677|EG001|Reported Event|Midazolam Group|"IV midazolam (1mg to 2mg max)~Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed"
11303275|NCT03069716|BG000|Baseline|Smartphone Text Messaging|"Group receives personalized, health coaching via smart text messages.~Smartphone Text Messaging: A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303276|NCT03069716|BG001|Baseline|No Smartphone Text Messaging|"Group does not receive personalized, health coaching via smart text messages.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303277|NCT03069716|BG002|Baseline|Total|Total of all reporting groups
11303278|NCT03069716|FG000|Participant Flow|Run-in Participants|participant is enrolled, they are given a fitbit device to wear for a 14 day run-in period leading up to the baseline visit.
11303279|NCT03069716|FG001|Participant Flow|Smartphone Text Messaging|"Group receives personalized, health coaching via smart text messages.~Smartphone Text Messaging: A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303280|NCT03069716|FG002|Participant Flow|No Smartphone Text Messaging|"Group does not receive personalized, health coaching via smart text messages.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303281|NCT03069716|OG000|Outcome|Smartphone Text Messaging|"Group receives personalized, health coaching via smart text messages.~Smartphone Text Messaging: A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."
11303282|NCT03069716|OG001|Outcome|No Smartphone Text Messaging|"Group does not receive personalized, health coaching via smart text messages."
11303283|NCT03069716|OG000|Outcome|Smartphone Text Messaging|"Group receives personalized, health coaching via smart text messages."
11303284|NCT03069716|EG000|Reported Event|Smartphone Text Messaging|"Group receives personalized, health coaching via smart text messages.~Smartphone Text Messaging: A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303285|NCT03069716|EG001|Reported Event|No Smartphone Text Messaging|"Group does not receive personalized, health coaching via smart text messages.~Fitbit Charge HR: The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive."
11303286|NCT03069989|BG000|Baseline|Placebo|Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303287|NCT03069989|BG001|Baseline|GSK3008348 1000 mcg|Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
10848420|NCT00289900|OG001|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
11303288|NCT03069989|BG002|Baseline|Total|Total of all reporting groups
11303289|NCT03069989|FG000|Participant Flow|Placebo|Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303290|NCT03069989|FG001|Participant Flow|GSK3008348 1000 mcg|Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303291|NCT03069989|OG000|Outcome|Placebo|Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303292|NCT03069989|OG001|Outcome|GSK3008348 1000 mcg|Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303293|NCT03069989|OG000|Outcome|GSK3008348 1000 mcg|Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303294|NCT03069989|EG000|Reported Event|Placebo|Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303295|NCT03069989|EG001|Reported Event|GSK3008348 1000 mcg|Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2.
11303296|NCT03070171|BG000|Baseline|T-R-R-T|Subjects were treated with single oral dose, started in period 1 with 110 milligram (mg) Dabigatran etexilate tablet with 200 milliliter (mL) of water after an overnight fast of at least 10 hour (h), followed in period 2 and period 3 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
11303297|NCT03070171|BG001|Baseline|R-T-T-R|Subjects were treated with single oral dose, started in period 1 with 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, followed in period 2 and period 3 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
11303298|NCT03070171|BG002|Baseline|Total|Total of all reporting groups
11303299|NCT03070171|FG000|Participant Flow|T-R-R-T|Subjects were treated with single oral dose, started in period 1 with 110 milligram (mg) Dabigatran etexilate tablet with 200 milliliter (mL) of water after an overnight fast of at least 10 hour (h), followed in period 2 and period 3 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
10822267|NCT00075725|BG009|Baseline|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10848421|NCT00289900|OG000|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
11303300|NCT03070171|FG001|Participant Flow|R-T-T-R|Subjects were treated with single oral dose, started in period 1 with 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, followed in period 2 and period 3 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
11303301|NCT03070171|OG000|Outcome|Dabigatran Etexilate Tablet (T)|Patients were administered single oral dose of 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h
11303302|NCT03070171|OG001|Outcome|Dabigatran Etexilate Capsule (R)|Patients were administered single oral dose of110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h
11303303|NCT03070171|EG000|Reported Event|Dabigatran Etexilate Tablet (T)|Patients were administered single oral dose of 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h
11303304|NCT03070171|EG001|Reported Event|Dabigatran Etexilate Capsule (R)|Patients were administered single oral dose of110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h
11303305|NCT03070431|BG000|Baseline|High-precision RT 5x5 Gy in 1 Week|"Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.~High-precision RT 5x5 Gy in 1 week: Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week"
11303306|NCT03070431|FG000|Participant Flow|High-precision RT 5x5 Gy in 1 Week|"Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.~High-precision RT 5x5 Gy in 1 week: Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week"
11303307|NCT03070431|OG000|Outcome|High-precision Radiotherapy 5x5 Gy in 1 Week|"Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.~High-precision radiotherapy 5x5 Gy in 1 week: Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week"
11303308|NCT03070431|OG000|Outcome|High-precision RT 5x5 Gy in 1 Week|"Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.~High-precision RT 5x5 Gy in 1 week: Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week"
11303309|NCT03070431|OG000|Outcome|Patients With Sensory Deficits at Baseline|Patients who had sensory deficits prior to the start of radiotherapy.
11303310|NCT03070431|OG000|Outcome|Patients With Sphincter Dysfunction at Baseline|Patients who had a sphincter dysfunction prior to the start of radiotherapy.
11303311|NCT03070431|OG000|Outcome|Patients With a Pain Score of >1 at Baseline|Patients who had a pain score of >1 prior to the start of RT and were evaluable for pain relief at 1 month following RT.
11303312|NCT03070431|OG000|Outcome|Patients With a Distress Score of >1 at Baseline|Patients who had a distress score of >1 prior to the start of RT and were evaluable for relief of distress at 1 month following RT.
10848422|NCT00289900|EG000|Reported Event|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
11303313|NCT03070431|EG000|Reported Event|High-precision RT 5x5 Gy in 1 Week|"Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.~High-precision RT 5x5 Gy in 1 week: Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week"
11303314|NCT03070470|BG000|Baseline|Ranolazine|"Ranolazine 1500 mg two times per day for 2.5 days~Ranolazine: Ranolazine 1500 mg orally two times per day for 2.5 days"
11303315|NCT03070470|BG001|Baseline|Verapamil|"Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3~Verapamil: Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)"
11303316|NCT03070470|BG002|Baseline|Lopinavir / Ritonavir|"Lopinavir / Ritonavir 800 mg / 200 mg two times per day for 2.5 days~Lopinavir / Ritonavir: Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days"
11303317|NCT03070470|BG003|Baseline|Chloroquine|"Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3~Chloroquine: Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)"
10848423|NCT00289900|EG001|Reported Event|MK-0524B 2g/40 mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
11303318|NCT03070470|BG004|Baseline|Placebo|"Placebo capsules~Placebo: Placebo (administered orally)"
11303319|NCT03070470|BG005|Baseline|Dofetilide and Diltiazem|"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10.~Dofetilide and Diltiazem: In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303320|NCT03070470|BG006|Baseline|Total|Total of all reporting groups
11303321|NCT03070470|FG000|Participant Flow|Ranolazine|"Ranolazine 1500 mg two times per day for 2.5 days~Ranolazine: Ranolazine 1500 mg orally two times per day for 2.5 days"
11303322|NCT03070470|FG001|Participant Flow|Verapamil|"Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3~Verapamil: Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)"
11303323|NCT03070470|FG002|Participant Flow|Lopinavir / Ritonavir|"Lopinavir / Ritonavir 800 mg / 200 mg two times per day for 2.5 days~Lopinavir / Ritonavir: Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days"
11303324|NCT03070470|FG003|Participant Flow|Chloroquine|"Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3~Chloroquine: Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)"
11303325|NCT03070470|FG004|Participant Flow|Placebo|"Placebo capsules~Placebo: Placebo (administered orally)"
11303326|NCT03070470|FG005|Participant Flow|Dofetilide and Diltiazem|"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10.~Dofetilide and Diltiazem: In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303327|NCT03070470|OG000|Outcome|Ranolazine|"Ranolazine 1500 mg two times per day for 2.5 days~Ranolazine: Ranolazine 1500 mg orally two times per day for 2.5 days"
11303328|NCT03070470|OG001|Outcome|Verapamil|"Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3~Verapamil: Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)"
11303329|NCT03070470|OG002|Outcome|Lopinavir / Ritonavir|"Lopinavir / Ritonavir 800 mg / 200 mg two times per day for 2.5 days~Lopinavir / Ritonavir: Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days"
11303330|NCT03070470|OG003|Outcome|Chloroquine|"Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3~Chloroquine: Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)"
11303331|NCT03070470|OG004|Outcome|Placebo|"Placebo capsules~Placebo: Placebo (administered orally)"
11303332|NCT03070470|OG005|Outcome|Dofetilide and Diltiazem|"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10.~Dofetilide and Diltiazem: In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303333|NCT03070470|OG005|Outcome|Dofetilide|"Data from the Dofetilide alone period of the crossover part:~In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303334|NCT03070470|OG006|Outcome|Diltiazem+Dofetilide|"Data from the diltiazem and dofetilide period of the crossover part:~In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303335|NCT03070470|EG000|Reported Event|Ranolazine|"Ranolazine 1500 mg two times per day for 2.5 days~Ranolazine: Ranolazine 1500 mg orally two times per day for 2.5 days"
11303336|NCT03070470|EG001|Reported Event|Verapamil|"Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3~Verapamil: Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)"
11303337|NCT03070470|EG002|Reported Event|Lopinavir / Ritonavir|"Lopinavir / Ritonavir 800 mg / 200 mg two times per day for 2.5 days~Lopinavir / Ritonavir: Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days"
11303338|NCT03070470|EG003|Reported Event|Chloroquine|"Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3~Chloroquine: Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)"
11303339|NCT03070470|EG004|Reported Event|Placebo|"Placebo capsules~Placebo: Placebo (administered orally)"
11303340|NCT03070470|EG005|Reported Event|Dofetilide and Diltiazem|"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10.~Dofetilide and Diltiazem: In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
11303341|NCT03070483|BG000|Baseline|Vitamin D|"Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months~Cholecalciferol: 5000 IU cholecalciferol with 1000 mg calcium citrate daily"
11303342|NCT03070483|FG000|Participant Flow|Vitamin D Arm|All participants received cholecalciferol 5000 IU orally and calcium citrate 1000 mg orally daily for 12 weeks
11303343|NCT03070483|OG000|Outcome|Vitamin D Arm|All participants received vitamin D and calcium supplementation
11303344|NCT03070483|OG000|Outcome|Vitamin D|"Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months~Cholecalciferol: 5000 IU cholecalciferol with 1000 mg calcium citrate daily"
11303345|NCT03070483|EG000|Reported Event|Vitamin D|"Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months~Cholecalciferol: 5000 IU cholecalciferol with 1000 mg calcium citrate daily"
11303346|NCT03070548|BG000|Baseline|Talazoparib|Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
11303347|NCT03070548|FG000|Participant Flow|Talazoparib|Participants with advanced solid tumors received a single dose of talazoparib 1 miligram (mg) oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
11303348|NCT03070548|OG000|Outcome|Talazoparib|Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
10848424|NCT00289900|EG002|Reported Event|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
10848425|NCT00289900|EG003|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
11303349|NCT03070548|EG000|Reported Event|Talazoparib|Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
11303350|NCT03070730|BG000|Baseline|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303351|NCT03070730|BG001|Baseline|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
11303352|NCT03070730|BG002|Baseline|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303353|NCT03070730|BG003|Baseline|Total|Total of all reporting groups
11303354|NCT03070730|FG000|Participant Flow|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303355|NCT03070730|FG001|Participant Flow|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
11303356|NCT03070730|FG002|Participant Flow|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303357|NCT03070730|OG000|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303358|NCT03070730|OG001|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
11303359|NCT03070730|OG002|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303360|NCT03070730|EG000|Reported Event|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303361|NCT03070730|EG001|Reported Event|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
11303362|NCT03070730|EG002|Reported Event|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
11303363|NCT03070782|BG000|Baseline|Cohort A: ISIS 681257: 20 mg Q4W|Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
11303364|NCT03070782|BG001|Baseline|Cohort B: ISIS 681257: 40 mg Q4W|Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303365|NCT03070782|BG002|Baseline|Cohort C: ISIS 681257: 60 mg Q4W|Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
10848426|NCT00289900|EG004|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
10848427|NCT00289900|EG005|Reported Event|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
10848428|NCT00289913|BG000|Baseline|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303366|NCT03070782|BG003|Baseline|Cohort D: ISIS 681257: 20 mg Q2W|Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
11303367|NCT03070782|BG004|Baseline|Cohort E: ISIS 681257: 20 mg QW|Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
11303368|NCT03070782|BG005|Baseline|Placebo|Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
11303369|NCT03070782|BG006|Baseline|Total|Total of all reporting groups
11303370|NCT03070782|FG000|Participant Flow|Cohort A: ISIS 681257: 20 mg Q4W|Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
11303371|NCT03070782|FG001|Participant Flow|Cohort B: ISIS 681257: 40 mg Q4W|Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303372|NCT03070782|FG002|Participant Flow|Cohort C: ISIS 681257: 60 mg Q4W|Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303373|NCT03070782|FG003|Participant Flow|Cohort D: ISIS 681257: 20 mg Q2W|Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
11303374|NCT03070782|FG004|Participant Flow|Cohort E: ISIS 681257: 20 mg QW|Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
11303375|NCT03070782|FG005|Participant Flow|Placebo|Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
11303376|NCT03070782|OG000|Outcome|Cohort A: ISIS 681257: 20 mg Q4W|Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
11303377|NCT03070782|OG001|Outcome|Cohort B: ISIS 681257: 40 mg Q4W|Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303378|NCT03070782|OG002|Outcome|Cohort C: ISIS 681257: 60 mg Q4W|Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303379|NCT03070782|OG003|Outcome|Cohort D: ISIS 681257: 20 mg Q2W|Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
11303380|NCT03070782|OG004|Outcome|Cohort E: ISIS 681257: 20 mg QW|Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
11303381|NCT03070782|OG005|Outcome|Placebo|Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
11303382|NCT03070782|EG000|Reported Event|Cohort A: ISIS 681257: 20 mg Q4W|Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
11303383|NCT03070782|EG001|Reported Event|Cohort B: ISIS 681257: 40 mg Q4W|Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303384|NCT03070782|EG002|Reported Event|Cohort C: ISIS 681257: 60 mg Q4W|Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
11303385|NCT03070782|EG003|Reported Event|Cohort D: ISIS 681257: 20 mg Q2W|Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
11303386|NCT03070782|EG004|Reported Event|Cohort E: ISIS 681257: 20 mg QW|Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
11303387|NCT03070782|EG005|Reported Event|Placebo|Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
11303388|NCT03070964|BG000|Baseline|Plitidepsin|Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
11303389|NCT03070964|FG000|Participant Flow|Plitidepsin|Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
10848429|NCT00289913|BG001|Baseline|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
11303390|NCT03070964|OG000|Outcome|Plitidepsin|Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
11303391|NCT03070964|EG000|Reported Event|Plitidepsin|Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
11303392|NCT03071094|BG000|Baseline|Pexa-Vec Combined With Nivolumab - Phase I|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303393|NCT03071094|BG001|Baseline|Pexa-Vec Combined With Nivolumab - Phase IIa|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303394|NCT03071094|BG002|Baseline|Total|Total of all reporting groups
11303395|NCT03071094|FG000|Participant Flow|Pexa-Vec Combined With Nivolumab - Phase I|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303396|NCT03071094|FG001|Participant Flow|Pexa-Vec Combined With Nivolumab - Phase IIa|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303397|NCT03071094|OG000|Outcome|Pexa-Vec Combined With Nivolumab - Phase I|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303398|NCT03071094|OG000|Outcome|Pexa-Vec Combined With Nivolumab - Phase I and Phase IIa|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303399|NCT03071094|EG000|Reported Event|Pexa-Vec Combined With Nivolumab - Phase I|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303400|NCT03071094|EG001|Reported Event|Pexa-Vec Combined With Nivolumab - Phase IIa|Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
11303401|NCT03071263|BG000|Baseline|Group 1 - Patiromer|"Spironolactone + blinded patiromer~Patiromer: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303402|NCT03071263|BG001|Baseline|Group 2 - Placebo|"Spironolactone + blinded placebo~Placebo: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303403|NCT03071263|BG002|Baseline|Total|Total of all reporting groups
11303404|NCT03071263|FG000|Participant Flow|Group 1 - Patiromer|"Spironolactone + blinded patiromer~Patiromer: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303405|NCT03071263|FG001|Participant Flow|Group 2 - Placebo|"Spironolactone + blinded placebo~Placebo: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303406|NCT03071263|OG000|Outcome|Group 1 - Patiromer|"Spironolactone + blinded patiromer~Patiromer: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303407|NCT03071263|OG001|Outcome|Group 2 - Placebo|"Spironolactone + blinded placebo~Placebo: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303408|NCT03071263|EG000|Reported Event|Group 1 - Patiromer|"Spironolactone + blinded patiromer~Patiromer: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303409|NCT03071263|EG001|Reported Event|Group 2 - Placebo|"Spironolactone + blinded placebo~Placebo: 2 packets/day starting dose, administered orally~Spironolactone: 25 mg tablet/day starting dose, administered orally"
11303410|NCT03071276|BG000|Baseline|Interventions: Selinexor, Fludarabine, and Cytarabine|Interventions: Selinexor, Fludarabine, and Cytarabine
11303411|NCT03071276|FG000|Participant Flow|Interventions: Selinexor, Fludarabine, and Cytarabine|Interventions: Selinexor, Fludarabine, and Cytarabine
11303412|NCT03071276|OG000|Outcome|Interventions: Selinexor, Fludarabine, and Cytarabine|Interventions: Selinexor, Fludarabine, and Cytarabine
11303413|NCT03071276|EG000|Reported Event|Interventions: Selinexor, Fludarabine, and Cytarabine|Interventions: Selinexor, Fludarabine, and Cytarabine
11303414|NCT03071744|BG000|Baseline|Lazanda|"Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions).~Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator.~Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution."
11303415|NCT03071744|FG000|Participant Flow|Lazanda|"Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions).~Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator.~Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution."
11303416|NCT03071744|OG000|Outcome|Lazanda|"Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions).~Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator.~Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution."
11332954|NCT03504852|EG002|Reported Event|Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)|2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
10848430|NCT00289913|BG002|Baseline|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303417|NCT03071744|EG000|Reported Event|Lazanda|"Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions).~Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator.~Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution."
11303418|NCT03071887|BG000|Baseline|Treatment: Relaxation Response Resiliency Program (3RP)|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators adapted the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.
11303419|NCT03071887|FG000|Participant Flow|Treatment: Relaxation Response Resiliency Program (3RP)|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators adapted the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.
11303420|NCT03071887|OG000|Outcome|Treatment: Relaxation Response Resiliency Program (3RP)|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators adapted the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.
11303421|NCT03071887|EG000|Reported Event|Treatment: Relaxation Response Resiliency Program (3RP)|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators adapted the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.
11303422|NCT03072160|BG000|Baseline|Cohort 1: Cancer Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 1: cancer vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303423|NCT03072160|BG001|Baseline|Cohort 2: Participants That Have Had No Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 2: had no previous vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303424|NCT03072160|BG002|Baseline|Total|Total of all reporting groups
11303425|NCT03072160|FG000|Participant Flow|Cohort 1: Cancer Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 1: cancer vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303426|NCT03072160|FG001|Participant Flow|Cohort 2: Participants That Have Had No Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 2: had no previous vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303427|NCT03072160|OG000|Outcome|Cohort 1: Cancer Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 1: cancer vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303428|NCT03072160|OG001|Outcome|Cohort 2: Participants That Have Had No Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 2: had no previous vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303429|NCT03072160|OG000|Outcome|All Participants at Day 1|"All participants in group 1 and group 2.~Group 1: cancer vaccine~Group 2: had no previous vaccine"
11303430|NCT03072160|OG001|Outcome|All Participants at Day 84|"All participants in group 1 and group 2.~Group 1: cancer vaccine~Group 2: had no previous vaccine"
11303431|NCT03072160|OG000|Outcome|Cohort 1: Grade 1 Possibly Related|Adverse events possibly related to Pembrolizumab.
11303432|NCT03072160|OG001|Outcome|Cohort 1: Grade 1 Probably Related|Adverse events probably related to Pembrolizumab.
11303433|NCT03072160|OG002|Outcome|Cohort 1: Grade 1 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303434|NCT03072160|OG003|Outcome|Cohort 1: Grade 2 Possibly Related|Adverse events possibly related to Pembrolizumab.
11303435|NCT03072160|OG004|Outcome|Cohort 1: Grade 2 Probably Related|Adverse events probably related to Pembrolizumab.
11303436|NCT03072160|OG005|Outcome|Cohort 1: Grade 2 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303437|NCT03072160|OG006|Outcome|Cohort 1: Grade 3 Possibly Related|Adverse events possibly related to Pembrolizumab.
11303438|NCT03072160|OG007|Outcome|Cohort 1: Grade 3 Probably Related|Adverse events probably related to Pembrolizumab.
11303439|NCT03072160|OG008|Outcome|Cohort 1: Grade 3 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303440|NCT03072160|OG009|Outcome|Cohort 2: Grade 1 Possibly Related|Adverse events possibly related to Pembrolizumab.
11332955|NCT03504852|EG003|Reported Event|All Patients|All Patients
11303441|NCT03072160|OG010|Outcome|Cohort 2: Grade 1 Probably Related|Adverse events probably related to Pembrolizumab.
11303442|NCT03072160|OG011|Outcome|Cohort 2: Grade 1 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303443|NCT03072160|OG012|Outcome|Cohort 2: Grade 2 Possibly Related|Adverse events possibly related to Pembrolizumab.
11303444|NCT03072160|OG013|Outcome|Cohort 2: Grade 2 Probably Related|Adverse events probably related to Pembrolizumab.
11303445|NCT03072160|OG014|Outcome|Cohort 2: Grade 2 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303446|NCT03072160|OG015|Outcome|Cohort 2: Grade 3 Possibly Related|Adverse events possibly related to Pembrolizumab.
11303447|NCT03072160|OG016|Outcome|Cohort 2: Grade 3 Probably Related|Adverse events probably related to Pembrolizumab.
11303448|NCT03072160|OG017|Outcome|Cohort 2: Grade 3 Definitely Related|Adverse events definitely related to Pembrolizumab.
11303449|NCT03072160|OG000|Outcome|Cohort 1: Grade 1 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
11303450|NCT03072160|OG001|Outcome|Cohort 1: Grade 1 Unrelated|Adverse events unrelated to Pembrolizumab.
11303451|NCT03072160|OG002|Outcome|Cohort 1: Grade 2 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
11303452|NCT03072160|OG003|Outcome|Cohort 1: Grade 2 Unrelated|Adverse events unrelated to Pembrolizumab.
11303453|NCT03072160|OG004|Outcome|Cohort 1: Grade 3 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
11303454|NCT03072160|OG005|Outcome|Cohort 1: Grade 3 Unrelated|Adverse events unrelated to Pembrolizumab.
11303455|NCT03072160|OG006|Outcome|Cohort 2: Grade 1 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
10848431|NCT00289913|BG003|Baseline|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
11303456|NCT03072160|OG007|Outcome|Cohort 2: Grade 1 Unrelated|Adverse events unrelated to Pembrolizumab.
11303457|NCT03072160|OG008|Outcome|Cohort 2: Grade 2 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
11303458|NCT03072160|OG009|Outcome|Cohort 2: Grade 2 Unrelated|Adverse events unrelated to Pembrolizumab.
11303459|NCT03072160|OG010|Outcome|Cohort 2: Grade 3 Unlikely Related|Adverse events unlikely related to Pembrolizumab.
11303460|NCT03072160|OG011|Outcome|Cohort 2: Grade 3 Unrelated|Adverse events unrelated to Pembrolizumab.
11303461|NCT03072160|EG000|Reported Event|Cohort 1: Cancer Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 1: had an immune stimulating cancer vaccine previously~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303462|NCT03072160|EG001|Reported Event|Cohort 2: Participants That Have Had No Vaccine|"Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.~Group 2: had no previous vaccine~Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."
11303463|NCT03072186|BG000|Baseline|Near-infrared Light Nasal Endoscope Used With ICG|"ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.~near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply."
11303464|NCT03072186|FG000|Participant Flow|Near-infrared Light Nasal Endoscope Used With ICG|"ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.~near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply."
11303465|NCT03072186|OG000|Outcome|Near-infrared Light Nasal Endoscope Used With ICG|"ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.~near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply."
11303466|NCT03072186|EG000|Reported Event|Near-infrared Light Nasal Endoscope Used With ICG|"ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.~near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply."
11303467|NCT03072550|BG000|Baseline|Multi-center Open Label|"Thirty Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail"
11303468|NCT03072550|FG000|Participant Flow|Multi-center Open Label|"26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail"
11303469|NCT03072550|OG000|Outcome|Multi-center Open Label|"26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail"
11303470|NCT03072550|EG000|Reported Event|Multi-center Open Label|"26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail"
11303471|NCT03072602|BG000|Baseline|African-American|"Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."
11303472|NCT03072602|BG001|Baseline|White|"Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."
11303473|NCT03072602|BG002|Baseline|Total|Total of all reporting groups
11303474|NCT03072602|FG000|Participant Flow|African American|"Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."
11303475|NCT03072602|FG001|Participant Flow|White|"Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."
11303476|NCT03072602|OG000|Outcome|African-American|"Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."
11303477|NCT03072602|OG001|Outcome|Whites|"Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."
11303478|NCT03072602|EG000|Reported Event|African American|"Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."
11332956|NCT03504917|BG000|Baseline|Balovaptan|Participants received 10 mg of oral administration balovaptan once a day (QD).
11332957|NCT03504917|BG001|Baseline|Placebo|Participants received matching placebo.
11332958|NCT03504917|BG002|Baseline|Total|Total of all reporting groups
11303479|NCT03072602|EG001|Reported Event|White|"Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.~Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).~Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."
11303480|NCT03072719|BG000|Baseline|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
11303481|NCT03072719|BG001|Baseline|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
11303482|NCT03072719|BG002|Baseline|Total|Total of all reporting groups
11303483|NCT03072719|FG000|Participant Flow|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
11303484|NCT03072719|FG001|Participant Flow|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
11303485|NCT03072719|OG000|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
11303486|NCT03072719|OG001|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
11303487|NCT03072719|EG000|Reported Event|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
11303488|NCT03072719|EG001|Reported Event|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
11303489|NCT03072732|BG000|Baseline|Study Arm 1 - Below Left Axilla|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below left axilla and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303490|NCT03072732|BG001|Baseline|Study Arm 2 - Upper Left Pectoral Area|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303491|NCT03072732|BG002|Baseline|Total|Total of all reporting groups
11303492|NCT03072732|FG000|Participant Flow|Study Arm 1 - Below the Left Axilla|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below the left axilla and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303493|NCT03072732|FG001|Participant Flow|Study Arm 2 - Upper Left Pectoral Area|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303494|NCT03072732|OG000|Outcome|Study Arm 1 - Below Left Axilla|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below the left axilla and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303495|NCT03072732|OG001|Outcome|Study Arm 2 - Upper Left Pectoral Area|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303496|NCT03072732|EG000|Reported Event|Study Arm 1 - Below Left Axilla|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below left axilla and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303497|NCT03072732|EG001|Reported Event|Study Arm 2 - Upper Left Pectoral Area|"20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor~u-Cor System: Monitoring System~ZOE Fluid Status Monitor: Monitoring System"
11303498|NCT03072875|BG000|Baseline|CAMS-RAS|"In this single-arm study design, all enrolled patient and non-patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.~CAMS-RAS"
11303499|NCT03072875|FG000|Participant Flow|CAMS-RAS|"In this single-arm study design, all enrolled patient and non-patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.~CAMS-RAS"
11332959|NCT03504917|FG000|Participant Flow|Balovaptan|Participants received 10 mg of oral administration balovaptan once a day (QD).
11303500|NCT03072875|OG000|Outcome|CAMS-RAS|"In this single-arm study design, all enrolled patient and non-patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.~CAMS-RAS"
11303501|NCT03072875|OG000|Outcome|CAMS-RAS|"In this single-arm study design, all enrolled patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.~CAMS-RAS"
11303502|NCT03072875|EG000|Reported Event|CAMS-RAS|"In this single-arm study design, all enrolled patient and non-patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.~CAMS-RAS"
11303503|NCT03072953|BG000|Baseline|APD334|During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
11303504|NCT03072953|FG000|Participant Flow|APD334|During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
11303505|NCT03072953|OG000|Outcome|APD334|During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
11303506|NCT03072953|EG000|Reported Event|APD334|During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
11303507|NCT03073005|BG000|Baseline|Traditional VAD Training (Patients)|Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303508|NCT03073005|BG001|Baseline|Traditional VAD Training (Caregivers)|Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303509|NCT03073005|BG002|Baseline|Simulation-based VAD Training (Patients)|"Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303510|NCT03073005|BG003|Baseline|Simulation-based VAD Training (Caregivers)|"Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303511|NCT03073005|BG004|Baseline|Total|Total of all reporting groups
11303512|NCT03073005|FG000|Participant Flow|Traditional VAD Training (Patients)|Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303513|NCT03073005|FG001|Participant Flow|Traditional VAD Training (Caregivers)|Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303514|NCT03073005|FG002|Participant Flow|Simulation-based VAD Training (Patients)|"Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303515|NCT03073005|FG003|Participant Flow|Simulation-based VAD Training (Caregivers)|"Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303516|NCT03073005|OG000|Outcome|Traditional VAD Training (Patients)|Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303517|NCT03073005|OG001|Outcome|Traditional VAD Training (Caregivers)|Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303518|NCT03073005|OG002|Outcome|Simulation-based VAD Training (Patients)|"Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11332960|NCT03504917|FG001|Participant Flow|Placebo|Participants received matching placebo in Blinded Treatment Period and 10 mg of oral administration balovaptan once a day (QD) in OLE Treatment period
11332961|NCT03504917|OG000|Outcome|Balovaptan|Participants received 10 mg of oral administration balovaptan once a day (QD).
11332962|NCT03504917|OG001|Outcome|Placebo|Participants received matching placebo.
11303519|NCT03073005|OG003|Outcome|Simulation-based VAD Training (Caregivers)|"Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303520|NCT03073005|OG000|Outcome|Traditional VAD Training (Patients)|Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303521|NCT03073005|OG001|Outcome|Simulation-based VAD Training (Patients)|"Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303522|NCT03073005|OG001|Outcome|Traditional VAD Training (Caregivers)|Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303523|NCT03073005|OG002|Outcome|Simulation-based VAD Training (Patients)|"Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303524|NCT03073005|OG003|Outcome|Simulation-based VAD Training (Caregivers)|"Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303525|NCT03073005|EG000|Reported Event|Traditional VAD Training (Patients)|Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.
11303526|NCT03073005|EG001|Reported Event|Simulation-based VAD Training (Patients)|"Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management~Simulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team."
11303527|NCT03073109|BG000|Baseline|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303528|NCT03073109|BG001|Baseline|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303529|NCT03073109|BG002|Baseline|Total|Total of all reporting groups
11303530|NCT03073109|FG000|Participant Flow|Tofacitinib|Participants with rheumatoid arthritis (RA) treated with tofacitinib after failure of conventional disease-modifying anti-rheumatic drugs (DMARDs) were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303531|NCT03073109|FG001|Participant Flow|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303532|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
11303533|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
11303534|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were time to supply, access limitation, methotrexate concomitant, chloro-quine concomitant and participant access.
10848432|NCT00289913|BG004|Baseline|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
10848433|NCT00289913|BG005|Baseline|Total|Total of all reporting groups
11303535|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were sensitive joints, leflunomide concomitant, chloro-quine concomitant and public access.
11303536|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was access limitation.
11303537|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was access limitation.
11303538|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were interruption of treatment and time to supply.
11303539|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was public access.
11303540|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation and interruption of treatment.
11303541|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation and interruption of treatment.
11303542|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were participant access, years since diagnosis, age, chloroquine concomitant, interruption of treatment, time to supply, access limitation, neutrophils, start treatment, methotrexate concomitant and chloroquine concomitant.
11303543|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation, years since diagnosis, leflunomide, chloroquine, chloroquine concomitant and public access.
10848434|NCT00289913|FG000|Participant Flow|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303544|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303545|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303546|NCT03073109|OG000|Outcome|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were interruption of treatment, time to supply, access limitation, lymphocytes, neutrophils, swollen joints and corticoids concomitant.
11303547|NCT03073109|OG001|Outcome|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were time to supply, sensitive joints and public access.
11303548|NCT03073109|EG000|Reported Event|Tofacitinib|Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303549|NCT03073109|EG001|Reported Event|Biologics|Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
11303550|NCT03073148|BG000|Baseline|Tangible Boost|"Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.~Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses."
11332963|NCT03504917|OG000|Outcome|Balovaptan Treatment|Participants received 10 mg of oral administration balovaptan once a day (QD). Blinded Treatment Period
11332964|NCT03504917|OG001|Outcome|Placebo Treatment|Participants received matching placebo. Blinded Treatment Period
11303551|NCT03073148|BG001|Baseline|Control|"Participants will treat their lenses with a placebo Tangible Boost kit containing saline after 30 days and again after 60 days.~Placebo saline: Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution."
11303552|NCT03073148|BG002|Baseline|Total|Total of all reporting groups
11303553|NCT03073148|FG000|Participant Flow|Tangible Boost|"Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.~Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses."
11303554|NCT03073148|FG001|Participant Flow|Control|"Participants will treat their lenses with a placebo Tangible Boost kit containing saline after 30 days and again after 60 days.~Placebo saline: Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution."
11303555|NCT03073148|FG002|Participant Flow|Unassigned|Subjects that did not report back for visit 3 and were therefore not assigned to a treatment group.
11303556|NCT03073148|OG000|Outcome|Tangible Boost|"Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.~Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses."
10971847|NCT00917735|FG000|Participant Flow|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
11303557|NCT03073148|OG001|Outcome|Control|"Participants will treat their lenses with a placebo Tangible Boost kit containing saline after 30 days and again after 60 days.~Placebo saline: Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution."
11303558|NCT03073148|OG002|Outcome|Unassigned|Dropped out of study prior to assignment.
11303559|NCT03073148|EG000|Reported Event|Tangible Boost|"Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.~Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses."
11303560|NCT03073148|EG001|Reported Event|Control|"Participants will treat their lenses with a placebo Tangible Boost kit containing saline after 30 days and again after 60 days.~Placebo saline: Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution."
11303561|NCT03073148|EG002|Reported Event|Unassigned|Dropped out of study prior to assignment.
11303562|NCT03073200|BG000|Baseline|Placebo|Participants received matching placebo for Ixekizumab by subcutaneous injection.
11303563|NCT03073200|BG001|Baseline|Ixekizumab|"Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection."
11303564|NCT03073200|BG002|Baseline|Open-label Etanercept|Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
11303565|NCT03073200|BG003|Baseline|Total|Total of all reporting groups
11303566|NCT03073200|FG000|Participant Flow|PBO (Double-Blinded Treatment Period)|Participants received matching placebo (PBO) for Ixekizumab (IXE) by subcutaneous injection.
11303567|NCT03073200|FG001|Participant Flow|IXEQ4W (Double-Blinded Treatment Period)|"Participants with >50 kilogram (kg) weight received 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection."
11303568|NCT03073200|FG002|Participant Flow|ETN (Double-Blinded Treatment Period)|Participants received 0.8 milligrams per kilogram (mg/kg) Etanercept (ETN) not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
11303569|NCT03073200|FG003|Participant Flow|PBO/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303570|NCT03073200|FG004|Participant Flow|IXEQ4W/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303571|NCT03073200|FG005|Participant Flow|ETN/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303572|NCT03073200|FG006|Participant Flow|PBO/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303573|NCT03073200|FG007|Participant Flow|IXEQ4W/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303574|NCT03073200|FG008|Participant Flow|ETN/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303575|NCT03073200|FG009|Participant Flow|PBO (Randomized Withdrawal Period)|Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.
11303576|NCT03073200|FG010|Participant Flow|IXEQ4W (Randomized Withdrawal Period)|Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.
11303577|NCT03073200|FG011|Participant Flow|IXEQ4W_Re-Treatment (Randomized Withdrawal) Period|Participants from EU countries who do not meet the response criterion at Week 60 continued with open-label treatment with ixekizumab.
11303578|NCT03073200|FG012|Participant Flow|PBO (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303579|NCT03073200|FG013|Participant Flow|IXEQ4W (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303580|NCT03073200|FG014|Participant Flow|ETN (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303581|NCT03073200|OG000|Outcome|Placebo|Participants received matching placebo for Ixekizumab by subcutaneous injection.
11303582|NCT03073200|OG001|Outcome|Ixekizumab|"Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection."
11303583|NCT03073200|OG000|Outcome|Ixekizumab (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303584|NCT03073200|OG000|Outcome|Ixekizumab|"Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection."
11303585|NCT03073200|OG002|Outcome|Open-Label Etanercept|Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
11303586|NCT03073200|EG000|Reported Event|PBO (Double-Blinded Treatment Period)|Participants received matching placebo for Ixekizumab by subcutaneous injection.
10848435|NCT00289913|FG001|Participant Flow|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
10971848|NCT00917735|FG001|Participant Flow|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
11303587|NCT03073200|EG001|Reported Event|IXEQ4W (Double-Blinded Treatment Period)|"Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.~Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection."
11303588|NCT03073200|EG002|Reported Event|ETN (Double-Blinded Treatment Period)|Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
11303589|NCT03073200|EG003|Reported Event|PBO/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303590|NCT03073200|EG004|Reported Event|IXEQ4W/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303591|NCT03073200|EG005|Reported Event|ETN/IXEQ4W (Maintenance Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303592|NCT03073200|EG006|Reported Event|PBO/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303593|NCT03073200|EG007|Reported Event|IXEQ4W/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303594|NCT03073200|EG008|Reported Event|ETN/IXEQ4W/IXEQ4W (Extension Period)|"Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.~Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection."
11303595|NCT03073200|EG009|Reported Event|PBO (Randomized Withdrawal Period)|Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.
11303596|NCT03073200|EG010|Reported Event|IXEQ4W (Randomized Withdrawal Period)|Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.
11303597|NCT03073200|EG011|Reported Event|IXEQ4W_Re-Treatment (Randomized Withdrawal) Period|Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.
11303598|NCT03073200|EG012|Reported Event|PBO (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303599|NCT03073200|EG013|Reported Event|IXEQ4W (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303600|NCT03073200|EG014|Reported Event|ETN (Post-Treatment Follow-Up)|Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
11303601|NCT03073213|BG000|Baseline|Ixekizumab Single Dose|Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
11303602|NCT03073213|BG001|Baseline|Ixekizumab 80mg Q2W Multiple Dose|Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
11303603|NCT03073213|BG002|Baseline|Ixekizumab 80mg Q4W Multiple Dose|Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
11303604|NCT03073213|BG003|Baseline|Total|Total of all reporting groups
11303605|NCT03073213|FG000|Participant Flow|Ixekizumab Single Dose|Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
10822268|NCT00075725|BG010|Baseline|Dexamethasone, Capizzi Methotrexate Down Syndrome|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10848436|NCT00289913|FG002|Participant Flow|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303606|NCT03073213|FG001|Participant Flow|Ixekizumab 80mg Q2W Multiple Dose|Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
11303607|NCT03073213|FG002|Participant Flow|Ixekizumab 80mg Q4W Multiple Dose|Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
11303608|NCT03073213|OG000|Outcome|Ixekizumab Single Dose|Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
11303609|NCT03073213|OG000|Outcome|Ixekizumab 80mg Q2W Multiple Dose|Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
11303610|NCT03073213|OG001|Outcome|Ixekizumab 80mg Q4W Multiple Dose|Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
11303611|NCT03073213|OG000|Outcome|Ixekizumab 80mg Q4W Multiple Dose|Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
11303612|NCT03073213|EG000|Reported Event|Ixekizumab Single Dose|Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
11303613|NCT03073213|EG001|Reported Event|Ixekizumab 80mg Q2W Multiple Dose|Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
11303614|NCT03073213|EG002|Reported Event|Ixekizumab 80mg Q4W Multiple Dose|Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
10848437|NCT00289913|FG003|Participant Flow|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
10848438|NCT00289913|FG004|Participant Flow|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
11303615|NCT03073486|BG000|Baseline|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11303616|NCT03073486|BG001|Baseline|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11303617|NCT03073486|BG002|Baseline|Total|Total of all reporting groups
11303618|NCT03073486|FG000|Participant Flow|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11303619|NCT03073486|FG001|Participant Flow|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11303620|NCT03073486|OG000|Outcome|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11303621|NCT03073486|OG001|Outcome|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11303622|NCT03073486|EG000|Reported Event|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
11303623|NCT03073486|EG001|Reported Event|Olumacostat Glasaretil Gel, Vehicle|Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
11303624|NCT03073759|BG000|Baseline|dTCS|Patients received dTCS
11303625|NCT03073759|BG001|Baseline|Sham|Subjects received Sham stimulation
11303626|NCT03073759|BG002|Baseline|Total|Total of all reporting groups
11303627|NCT03073759|FG000|Participant Flow|dTCS|patients received dTCS
11303628|NCT03073759|FG001|Participant Flow|Sham|Subjects received Sham stimulation
11303629|NCT03073759|OG000|Outcome|dTCS|"Patient will receive dTCS with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA) or Sham stimulation.~dTCS: Direct current (DC) (maximum of 2 mA) stimulation delivered through surface electrodes. One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead."
11303630|NCT03073759|OG001|Outcome|Sham|Subjects received Sham stimulation
11303631|NCT03073759|OG000|Outcome|dTCS|patients received dTCS
11303632|NCT03073759|EG000|Reported Event|dTCS|patients received dTCS
11303633|NCT03073759|EG001|Reported Event|Sham|Subjects received Sham stimulation
11303634|NCT03073798|BG000|Baseline|All Participants|"Roflumilast. 500 mcg of Roflumilast daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of placebo.~Roflumilast: 500 mcg of Roflumilast which is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms~Placebo: 500 mcg of placebo is used"
11303635|NCT03073798|FG000|Participant Flow|All Participants|Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.
11303636|NCT03073798|OG000|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
11303637|NCT03073798|OG001|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
11303638|NCT03073798|EG000|Reported Event|All Participants|"Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.~MCC was conducted at baseline and at the end of each 4 week medication phase."
11303639|NCT03073876|BG000|Baseline|Drug|"Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303640|NCT03073876|BG001|Baseline|Placebo|"Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.~The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth~Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months."
11303641|NCT03073876|BG002|Baseline|Total|Total of all reporting groups
11303642|NCT03073876|FG000|Participant Flow|Drug|"Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303643|NCT03073876|FG001|Participant Flow|Placebo|"Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.~The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth~Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months."
11303644|NCT03073876|OG000|Outcome|Drug|"Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303645|NCT03073876|OG001|Outcome|Placebo|"Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.~The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth~Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months."
11303646|NCT03073876|OG000|Outcome|Drug|treatment group
11303647|NCT03073876|OG001|Outcome|Placebo|placebo group
11303648|NCT03073876|OG000|Outcome|Drug Treatment|"All Participants received Donepezil Hydrochloride daily for 6 weeks.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303649|NCT03073876|OG000|Outcome|Drug Treatment|"All Participants received Donepezil Hydrochloride daily for 6 months.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303650|NCT03073876|OG000|Outcome|Drug|"Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11303651|NCT03073876|EG000|Reported Event|Drug|"Participants in the Drug group received oral 5mg of Donepezil Hydrochloride daily for 6 months. The Drug group was assessed at baseline, after approximately 6 weeks and after 6 months of treatment. The baseline to 6 weeks phase was part of the double-blind, placebo controlled portion of the trial.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth"
11332965|NCT03504917|OG002|Outcome|Balovaptan OLE|Participants received 10 mg of oral administration balovaptan once a day (QD). OLE Treatment Period
11332966|NCT03504917|OG003|Outcome|Placebo OLE|Participants received matching placebo in Blinded Treatment Period and 10 mg of oral administration balovaptan once a day (QD). OLE Treatment Period
10848439|NCT00289913|OG000|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11332967|NCT03504917|EG000|Reported Event|Balovaptan in Blinded Treatment Period|Participants received 10 mg of oral administration balovaptan once a day (QD).
11332968|NCT03504917|EG001|Reported Event|Placebo Blinded Treatment Period|Participants received matching placebo.
11332969|NCT03504917|EG002|Reported Event|Balovaptan in Open Label Extension Treatment Period|Participants received 10 mg of oral administration balovaptan once a day (QD).
11332970|NCT03504917|EG003|Reported Event|Placebo in Open Label Extension Treatment Period|Participants received matching placebo in Blinded Treatment Period and 10 mg of oral administration balovaptan once a day (QD). OLE Treatment Period
11332971|NCT03505190|BG000|Baseline|RO7062931 0.3mg/kg|Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
11332972|NCT03505190|BG001|Baseline|RO7062931 1.0mg/kg|Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
11332973|NCT03505190|BG002|Baseline|RO7062931 2.0mg/kg|Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
11332974|NCT03505190|BG003|Baseline|RO7062931 4.0mg/kg|Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
11332975|NCT03505190|BG004|Baseline|Placebo|Participants will receive matching placebo.
11332976|NCT03505190|BG005|Baseline|Total|Total of all reporting groups
11332977|NCT03505190|FG000|Participant Flow|RO7062931 0.3mg/kg|Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
11332978|NCT03505190|FG001|Participant Flow|RO7062931 1.0mg/kg|Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
11303652|NCT03073876|EG001|Reported Event|Placebo|"Participants in the placebo group first received oral administration of a placebo pill for approximately 6 weeks. After that initial interval, the study was unblinded and participants in the placebo group then received 5mg of donepezil hydrochloride treatment for 6 months.~The Placebo group was evaluated at baseline, after 6 weeks of placebo, after 6 weeks of donepezil hydrochloride drug treatment, and 6 months of donepezil hydrochloride treatment.~Donepezil Hydrochloride: 5mg of Donepezil Hydrochloride by mouth~Placebo: prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months."
11303653|NCT03074162|BG000|Baseline|A-B-R|"Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)~Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303654|NCT03074162|BG001|Baseline|B-R-A|"Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)~Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303655|NCT03074162|BG002|Baseline|R-A-B|"Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)~Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303656|NCT03074162|BG003|Baseline|R-B-A|"Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)~Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303657|NCT03074162|BG004|Baseline|A-R-B|"Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)~Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303658|NCT03074162|BG005|Baseline|B-A-R|"Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)~Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303659|NCT03074162|BG006|Baseline|Total|Total of all reporting groups
11303660|NCT03074162|FG000|Participant Flow|A-B-R|"Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)~Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303661|NCT03074162|FG001|Participant Flow|B-R-A|"Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)~Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303662|NCT03074162|FG002|Participant Flow|R-A-B|"Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)~Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303663|NCT03074162|FG003|Participant Flow|R-B-A|"Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)~Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303664|NCT03074162|FG004|Participant Flow|A-R-B|"Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)~Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303665|NCT03074162|FG005|Participant Flow|B-A-R|"Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)~Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.~All treatment periods were separated by a wash-out period of at least 7 days."
11303666|NCT03074162|OG000|Outcome|Diclofenac 2% (A)|Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
11303667|NCT03074162|OG001|Outcome|Diclofenac 2% + Capsaicin 0.075% (B)|Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
11303668|NCT03074162|OG002|Outcome|Voltarol® 2.32% Gel (R)|Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
11303669|NCT03074162|EG000|Reported Event|Diclofenac 2% (A)|Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
11303670|NCT03074162|EG001|Reported Event|Diclofenac 2% + Capsaicin 0.075% (B)|Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
11303671|NCT03074162|EG002|Reported Event|Voltarol® 2.32% Gel (R)|Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
11303672|NCT03074331|BG000|Baseline|SOF/VEL 12 Weeks|SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11303673|NCT03074331|FG000|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOL/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
11303674|NCT03074331|OG000|Outcome|SOF/VEL 12 Weeks|SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11303675|NCT03074331|EG000|Reported Event|SOF/VEL 12 Weeks|SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
11303676|NCT03074409|BG000|Baseline|Oxytocin|"intranasal administration of oxytocin~oxytocin: self-administration of oxytocin (nasal spray)"
11303677|NCT03074409|BG001|Baseline|Placebo|"intranasal administration of the same ingredient except oxytocin~placebo: self-administration of placebo (nasal spray)"
11303678|NCT03074409|BG002|Baseline|Total|Total of all reporting groups
11303679|NCT03074409|FG000|Participant Flow|Oxytocin|"intranasal administration of oxytocin~oxytocin: self-administration of oxytocin (nasal spray)"
11303680|NCT03074409|FG001|Participant Flow|Placebo|"intranasal administration of the same ingredient except oxytocin~placebo: self-administration of placebo (nasal spray)"
11303681|NCT03074409|OG000|Outcome|Oxytocin|"intranasal administration of oxytocin~oxytocin: self-administration of oxytocin (nasal spray)"
11303682|NCT03074409|OG001|Outcome|Placebo|"intranasal administration of the same ingredient except oxytocin~placebo: self-administration of placebo (nasal spray)"
11303683|NCT03074409|EG000|Reported Event|Oxytocin|"intranasal administration of oxytocin~oxytocin: self-administration of oxytocin (nasal spray)"
11303684|NCT03074409|EG001|Reported Event|Placebo|"intranasal administration of the same ingredient except oxytocin~placebo: self-administration of placebo (nasal spray)"
11303685|NCT03074500|BG000|Baseline|Kinesiotaping|"Kinesio taping by using space and fascia correction techniques on forearm of the patients for lateral epicondylitis treatment will be applied every 3 days for 2 weeks in addition to exercises.~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series."
11303686|NCT03074500|BG001|Baseline|Sham Taping|"Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series."
11303687|NCT03074500|BG002|Baseline|Control|"Only-exercises group: Stretching and strengthening exercises of wrist~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series."
11303688|NCT03074500|BG003|Baseline|Total|Total of all reporting groups
11303689|NCT03074500|FG000|Participant Flow|Kinesiotaping|"Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises~Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11332979|NCT03505190|FG002|Participant Flow|RO7062931 2.0mg/kg|Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
11303690|NCT03074500|FG001|Participant Flow|Control|"Stretching and strengthening exercises of wrist~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11303691|NCT03074500|FG002|Participant Flow|Sham Taping|"Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises~Sham taping: Sham taping will be performed without using any technique~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11303692|NCT03074500|OG000|Outcome|Kinesiotaping|"Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises~Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series."
11303693|NCT03074500|OG001|Outcome|Sham Taping|"Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises~Sham taping: Sham taping will be performed without using any technique~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series."
11303694|NCT03074500|OG002|Outcome|Control|"Stretching and strengthening exercises of wrist~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11303695|NCT03074500|OG000|Outcome|Kinesiotaping|"Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises~Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11303696|NCT03074500|OG001|Outcome|Sham Taping|"Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises~Sham taping: Sham taping will be performed without using any technique~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. ."
11303697|NCT03074500|EG000|Reported Event|Kinesiotaping|"Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises~Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series.~No adverse effect occured."
11303698|NCT03074500|EG001|Reported Event|Sham Taping|"Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises~Sham taping: Sham taping will be performed without using any technique~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series.~No adverse effect occured."
11303699|NCT03074500|EG002|Reported Event|Control|"Stretching and strengthening exercises of wrist~Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series.~No adverse effect occured."
11303700|NCT03074630|BG000|Baseline|Dapagliflozin|Nine male and 3 postmenopausal female participants were included. One female participant was excluded during the study due to missing data, as we were unable to place a venous catheter during the second hyperinsulinemic clamp, thus we present the analysis for the 11 evaluable participtans.
11303701|NCT03074630|FG000|Participant Flow|Dapagliflozin|Dapagliflozin treatment for 5 weeks
11303702|NCT03074630|OG000|Outcome|Dapagliflozin|5 weeks of dapagliflozin
11303703|NCT03074630|OG000|Outcome|Dapagliflozin|Dapagliflozin treatment for 5 weeks
11303704|NCT03074630|EG000|Reported Event|Adverse Events|5 weeks of dapagliflozin
11303705|NCT03074682|BG000|Baseline|Pressure Bag|"Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.~Pressure Bag: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303706|NCT03074682|BG001|Baseline|Push/Pull|"Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.~Push/Pull: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303707|NCT03074682|BG002|Baseline|Lifeflow|"Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.~Lifeflow: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303708|NCT03074682|BG003|Baseline|Total|Total of all reporting groups
11303709|NCT03074682|FG000|Participant Flow|Pressure Bag|"Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.~Pressure Bag: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303710|NCT03074682|FG001|Participant Flow|Push/Pull|"Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.~Push/Pull: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11332980|NCT03505190|FG003|Participant Flow|RO7062931 4.0mg/kg|Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
11332981|NCT03505190|FG004|Participant Flow|Placebo|Participants will receive matching placebo.
11332982|NCT03505190|OG000|Outcome|RO7062931 0.3mg/kg|Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
11303711|NCT03074682|FG002|Participant Flow|Lifeflow|"Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.~Lifeflow: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303712|NCT03074682|OG000|Outcome|Pressure Bag|"Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.~Pressure Bag: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303713|NCT03074682|OG001|Outcome|Push/Pull|"Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.~Push/Pull: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303714|NCT03074682|OG002|Outcome|Lifeflow|"Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.~Lifeflow: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303715|NCT03074682|EG000|Reported Event|Pressure Bag|"Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.~Pressure Bag: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303716|NCT03074682|EG001|Reported Event|Push/Pull|"Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.~Push/Pull: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303717|NCT03074682|EG002|Reported Event|Lifeflow|"Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.~Lifeflow: Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid."
11303718|NCT03075085|BG000|Baseline|Basic WISE Strategy|These participants were asked to implement WISE using a basic implementation strategy (training and reminders only).
11303719|NCT03075085|BG001|Baseline|Enhanced WISE Strategy|These participants were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
11303720|NCT03075085|BG002|Baseline|Total|Total of all reporting groups
11303721|NCT03075085|FG000|Participant Flow|Basic WISE Strategy|These participants were asked to implement WISE using a basic implementation strategy (training and reminders only)
11303722|NCT03075085|FG001|Participant Flow|Enhanced WISE Strategy|These participants were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
11303723|NCT03075085|OG000|Outcome|Basic WISE Strategy|These classrooms were asked to implement WISE using a basic implementation strategy (training and reminders only).
11303724|NCT03075085|OG001|Outcome|Enhanced WISE Strategy|These classrooms were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
11303725|NCT03075085|EG000|Reported Event|Basic WISE Strategy|These participants were asked to implement WISE using a basic implementation strategy (training and reminders only).
11303726|NCT03075085|EG001|Reported Event|Enhanced WISE Strategy|These participants were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
11303727|NCT03075163|BG000|Baseline|Acupressure|"Manual pressure will be applied on the wrists bilaterally.~Acupressure: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.~In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team."
11303728|NCT03075163|BG001|Baseline|Ondansetron|"Ondansetron (Zofran) is used for the treatment of nausea and vomiting.~Ondansetron: Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery."
10848440|NCT00289913|OG001|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
10848441|NCT00289913|OG002|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303729|NCT03075163|BG002|Baseline|Total|Total of all reporting groups
11303730|NCT03075163|FG000|Participant Flow|Acupressure|"Manual pressure will be applied on the wrists bilaterally.~Acupressure: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.~In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team."
11303731|NCT03075163|FG001|Participant Flow|Ondansetron|"Ondansetron (Zofran) is used for the treatment of nausea and vomiting.~Ondansetron: Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery."
11303732|NCT03075163|OG000|Outcome|Acupressure|"Manual pressure will be applied on the wrists bilaterally.~Acupressure: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.~In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team."
11303733|NCT03075163|OG001|Outcome|Ondansetron|"Ondansetron (Zofran) is used for the treatment of nausea and vomiting.~Ondansetron: Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery."
11303734|NCT03075163|EG000|Reported Event|Acupressure|"Manual pressure will be applied on the wrists bilaterally.~Acupressure: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.~In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team."
11303735|NCT03075163|EG001|Reported Event|Ondansetron|"Ondansetron (Zofran) is used for the treatment of nausea and vomiting.~Ondansetron: Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery."
11303736|NCT03075267|BG000|Baseline|PT010 (BGF MDI) 320/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11303737|NCT03075267|BG001|Baseline|PT010 (BGF MDI) 160/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
11303738|NCT03075267|BG002|Baseline|PT003 (GFF MDI) 14.4/9.6 µg|PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
11303739|NCT03075267|BG003|Baseline|Total|Total of all reporting groups
11303740|NCT03075267|FG000|Participant Flow|PT010 (BGF MDI) 320/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11303741|NCT03075267|FG001|Participant Flow|PT010 (BGF MDI) 160/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
11303742|NCT03075267|FG002|Participant Flow|PT003 (GFF MDI) 14.4/9.6 µg|PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
11303743|NCT03075267|OG000|Outcome|PT010 (BGF MDI) 320/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11303744|NCT03075267|OG001|Outcome|PT010 (BGF MDI) 160/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
11303745|NCT03075267|OG002|Outcome|PT003 (GFF MDI) 14.4/9.6 µg|PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
11303746|NCT03075267|EG000|Reported Event|PT010 (BGF MDI) 320/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11303747|NCT03075267|EG001|Reported Event|PT010 (BGF MDI) 160/14.4/9.6 µg|PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
11303748|NCT03075267|EG002|Reported Event|PT003 (GFF MDI) 14.4/9.6 µg|PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
11303749|NCT03075410|BG000|Baseline|Part A - Placebo/15 mg/25 mg/5 mg (Fed)|Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
11303750|NCT03075410|BG001|Baseline|Part A - Placebo/15 mg/25 mg/Placebo|Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303751|NCT03075410|BG002|Baseline|Part A - 5 mg/Placebo/25 mg/5 mg (Fed)|Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
10848442|NCT00289913|OG003|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
10848443|NCT00289913|OG004|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
11303752|NCT03075410|BG003|Baseline|Part A - 5 mg/Placebo/25 mg/Placebo|Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303753|NCT03075410|BG004|Baseline|Part A - 5 mg/15 mg/Placebo/5 mg (Fed)|Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
11303754|NCT03075410|BG005|Baseline|Part A - 5 mg/15 mg/Placebo/Placebo|Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303755|NCT03075410|BG006|Baseline|Part B-Placebo|Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
11303756|NCT03075410|BG007|Baseline|Part B-Repeat GSK3036656 5 mg|Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
11303757|NCT03075410|BG008|Baseline|Part B-Repeat GSK3036656 15 mg|Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
11303758|NCT03075410|BG009|Baseline|Total|Total of all reporting groups
11303759|NCT03075410|FG000|Participant Flow|PartA - Placebo/15 mg/25 mg/5 mg (Fed)|Participants received matching placebo to GSK3036656 5 milligrams (mg) followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
11303760|NCT03075410|FG001|Participant Flow|PartA - Placebo/15 mg/25 mg/Placebo|Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303761|NCT03075410|FG002|Participant Flow|PartA - 5 mg/Placebo/25 mg/5 mg (Fed)|Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
11303762|NCT03075410|FG003|Participant Flow|PartA - 5 mg/Placebo/25 mg/Placebo|Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303763|NCT03075410|FG004|Participant Flow|PartA - 5 mg/15 mg/Placebo/5 mg (Fed)|Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
11303764|NCT03075410|FG005|Participant Flow|PartA - 5 mg/15 mg/Placebo/Placebo|Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
11303765|NCT03075410|FG006|Participant Flow|Part B-Placebo|Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
11303766|NCT03075410|FG007|Participant Flow|Part B-Repeat GSK3036656 5 mg|Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
11303767|NCT03075410|FG008|Participant Flow|Part B-Repeat GSK3036656 15 mg|Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
11303768|NCT03075410|OG000|Outcome|Part A-Matching Placebo|Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
11303769|NCT03075410|OG001|Outcome|Part A-GSK3036656 5 mg|Participants received single dosing of GSK3036656 5 mg capsules orally.
11303770|NCT03075410|OG002|Outcome|Part A-GSK3036656 15 mg|Participants received single dosing of GSK3036656 15 mg capsules orally.
11303771|NCT03075410|OG003|Outcome|Part A-GSK3036656 25 mg|Participants received single dosing of GSK3036656 25 mg capsules orally.
11303772|NCT03075410|OG004|Outcome|Part A-GSK3036656 5 mg (Fed)|Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
11303773|NCT03075410|OG000|Outcome|Part B-Matching Placebo|Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
11303774|NCT03075410|OG001|Outcome|Part B-Repeat GSK3036656 5 mg|Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
11303775|NCT03075410|OG002|Outcome|Part B-Repeat GSK3036656 15 mg|Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
11303776|NCT03075410|OG000|Outcome|Part A-GSK3036656 5 mg|Participants received single dosing of GSK3036656 5 mg capsules orally.
11303777|NCT03075410|OG001|Outcome|Part A-GSK3036656 15 mg|Participants received single dosing of GSK3036656 15 mg capsules orally.
11303778|NCT03075410|OG002|Outcome|Part A-GSK3036656 25 mg|Participants received single dosing of GSK3036656 25 mg capsules orally.
11303779|NCT03075410|OG003|Outcome|Part A-GSK3036656 5 mg (Fed)|Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
11303780|NCT03075410|OG000|Outcome|Part B-Repeat GSK3036656 5 mg|Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
11303781|NCT03075410|OG001|Outcome|Part B-Repeat GSK3036656 15 mg|Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
11303782|NCT03075410|EG000|Reported Event|Part A-Matching Placebo|Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
11303783|NCT03075410|EG001|Reported Event|Part A-GSK3036656 5 mg|Participants received single dosing of GSK3036656 5 mg capsules orally.
11303784|NCT03075410|EG002|Reported Event|Part A-GSK3036656 15 mg|Participants received single dosing of GSK3036656 15 mg capsules orally.
11303785|NCT03075410|EG003|Reported Event|Part A-GSK3036656 25 mg|Participants received single dosing of GSK3036656 25 mg capsules orally.
11303786|NCT03075410|EG004|Reported Event|Part A-GSK3036656 5 mg (Fed)|Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
11303787|NCT03075410|EG005|Reported Event|Part B-Matching Placebo|Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
11303788|NCT03075410|EG006|Reported Event|Part B-GSK3036656 5 mg|Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
10848444|NCT00289913|OG000|Outcome|Concomitant VAQTA™ With Infanrix™ and PedvaxHIB™ or PedvaxHIB™|All participants receiving VAQTA™ Concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 1: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1); and Group 3: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1).
11303789|NCT03075410|EG007|Reported Event|Part B-GSK3036656 15 mg|Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
11303790|NCT03075449|BG000|Baseline|Participant Data Reported by Telephone Survey + Medical Record|Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
11303791|NCT03075449|FG000|Participant Flow|Participant Data Reported by Telephone Survey + Medical Record|Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
11303792|NCT03075449|OG000|Outcome|Participant Data Reported by Telephone Survey + Medical Record|Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
11303793|NCT03075449|EG000|Reported Event|Participant Data Reported by Telephone Survey + Medical Record|Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
11303794|NCT03075501|BG000|Baseline|Paired|"Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.~Paired: Drug conditioning is assessed by pairing drug administration with a given context.~Stimulant or sedative: CS+ for paired, CS0 for unpaired~Placebo: CS- for paired, CS0 for unpaired"
11303795|NCT03075501|BG001|Baseline|Unpaired|"Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms.~Stimulant or sedative: CS+ for paired, CS0 for unpaired~Placebo: CS- for paired, CS0 for unpaired"
11303796|NCT03075501|BG002|Baseline|Total|Total of all reporting groups
11332983|NCT03505190|OG001|Outcome|RO7062931 1.0mg/kg|Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
11303797|NCT03075501|FG000|Participant Flow|Paired|"Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.~Paired: Drug conditioning is assessed by pairing drug administration with a given context.~Stimulant or sedative: CS+ for paired, CS0 for unpaired~Placebo: CS- for paired, CS0 for unpaired"
11303798|NCT03075501|FG001|Participant Flow|Unpaired|"Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms.~Stimulant or sedative: CS+ for paired, CS0 for unpaired~Placebo: CS- for paired, CS0 for unpaired"
11303799|NCT03075501|OG000|Outcome|Paired|"Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo).~Paired: Participants always receive MA in the room that they spent the least time in at the pre-test exploration test, and placebo in the other room.~MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired"
11303800|NCT03075501|OG001|Outcome|Unpaired|"Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo).~Unpaired: Participants receive MA and placebo once in each room i.e., drug administration is not paired with a given room.~MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired"
11303801|NCT03075501|OG001|Outcome|Unpaired|"Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo).~Unpaired: Participants receive MA once in each room and placebo once in each room.~MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired"
11303802|NCT03075501|EG000|Reported Event|20mg Methamphetamine|"Participants completed two drug administration sessions with 20mg methamphetamine.~Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with None and at the right hand side with Extreme. Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects.~Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration.~Serious adverse events were defined as any side effects reported in the severe-extreme range (i.e., >60) or any occasion when the study physician was consulted about high cardiovascular measures.~Serious adverse events are reported for all participants who completed the study (N=109)."
11303803|NCT03075501|EG001|Reported Event|0mg Methamphetamine (Placebo)|"Participants completed two drug administration sessions with 20mg methamphetamine.~Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with None and at the right hand side with Extreme. Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects.~Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration.~Serious adverse events were defined as any side effects reported in the severe-extreme range (i.e., >60) or any occasion when the study physician was consulted about high cardiovascular measures.~Serious adverse events are reported for all participants who completed the study (N=109)."
11303804|NCT03075553|BG000|Baseline|Treatment (Nivolumab)|Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
11303805|NCT03075553|FG000|Participant Flow|Treatment (Nivolumab)|Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
11303806|NCT03075553|OG000|Outcome|Treatment (Nivolumab)|Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
11303807|NCT03075553|EG000|Reported Event|Treatment (Nivolumab)|Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
11303808|NCT03075644|BG000|Baseline|Norditropin®|Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).
10848445|NCT00289913|OG001|Outcome|Non-concomitant VAQTA™ Separate From Infanrix™ and PedvaxHIB™|All participants receiving VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 2: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1); and Group 4: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1).
11303809|NCT03075644|BG001|Baseline|Somapacitan|Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
11303810|NCT03075644|BG002|Baseline|Total|Total of all reporting groups
11303811|NCT03075644|FG000|Participant Flow|Norditropin®|Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).
11303812|NCT03075644|FG001|Participant Flow|Somapacitan|Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
11303813|NCT03075644|OG000|Outcome|Norditropin®|Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).
11303814|NCT03075644|OG001|Outcome|Somapacitan|Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
11303815|NCT03075644|OG000|Outcome|Somapacitan|Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
11303816|NCT03075644|EG000|Reported Event|Norditropin®|Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).
11303817|NCT03075644|EG001|Reported Event|Somapacitan|Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
11303818|NCT03075761|BG000|Baseline|Intervention|"Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.~Fitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.~30-minute education session"
11303819|NCT03075761|BG001|Baseline|Control|"Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period.~30-minute education session"
11303820|NCT03075761|BG002|Baseline|Total|Total of all reporting groups
11303821|NCT03075761|FG000|Participant Flow|Intervention|"Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.~Fitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.~30-minute education session"
11303822|NCT03075761|FG001|Participant Flow|Control|"Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period.~30-minute education session"
11303823|NCT03075761|OG000|Outcome|Inpatients and Outpatients With VTE|"All Inpatients and outpatients with VTE from following 3 sources:~(1) new patient referrals to the Bleeding Disorders and Thrombosis outpatient clinic, (2) inpatient admissions to the hematology service, and (3) inpatient consultations for VTE that were not on primary hematology service."
11303824|NCT03075761|OG000|Outcome|Eligible Subjects Who Consented|Screened subjects who met the eligibility criteria are included in this cohort.
11303825|NCT03075761|OG000|Outcome|FitBit Group's Adherence to Physical Activity|Targeted activity is defined as walking-jogging program to capture steps/day by the Fitbit during Active phase. If preferred or already involved, participants may perform strenuous muscle-strengthening or bone-strengthening exercises (eg, lifting weights, jumping rope, dancing, or team sports) to replace the walking-jogging program as long as the target goal for physical activity was met.
11303826|NCT03075761|OG000|Outcome|Standard of Care Group's Adherence to Physical Activity|Proportion of participants who completed and submitted physical activity questionnaires.
11303827|NCT03075761|OG000|Outcome|Intervention|"Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.~FitBit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.~30-minute education session"
11303828|NCT03075761|OG001|Outcome|Control|"Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period.~30-minute education session"
11303829|NCT03075761|OG000|Outcome|Intervention|"Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.~Fitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.~30-minute education session"
11303830|NCT03075761|EG000|Reported Event|Intervention|"Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.~Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.~30-minute education session"
11303831|NCT03075761|EG001|Reported Event|Control|"Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period.~30-minute education session"
11303832|NCT03075839|BG000|Baseline|Cigarette Brand Switching|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
11303833|NCT03075839|FG000|Participant Flow|Cigarette Brand Switching|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
11303834|NCT03075839|OG000|Outcome|Cigarette Brand Switching|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
11303835|NCT03075839|EG000|Reported Event|Cigarette Brand Switching|"Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes~Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes"
11303836|NCT03075878|BG000|Baseline|Cohort 1: ALXN1830|SYNT001 Dose 1: Participants received ALXN1830.
11303837|NCT03075878|FG000|Participant Flow|Cohort 1: ALXN1830|SYNT001 Dose 1: Participants received ALXN1830.
11303838|NCT03075878|OG000|Outcome|Cohort 1: ALXN1830|SYNT001 Dose 1: Participants received ALXN1830.
11303839|NCT03075878|EG000|Reported Event|Cohort 1: ALXN1830|SYNT001 Dose 1: Participants received ALXN1830.
11303840|NCT03075891|BG000|Baseline|Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks."
11303841|NCT03075891|BG001|Baseline|Ivermectin 1% Cream + Oral Placebo Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Oral placebo capsules: 1 Capsule once-daily for 12 weeks."
11303842|NCT03075891|BG002|Baseline|Total|Total of all reporting groups
11303843|NCT03075891|FG000|Participant Flow|Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules|"Ivermectin 1% (percent) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Doxycycline 40 mg (milligram) Modified Release (MR) (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks."
11303844|NCT03075891|FG001|Participant Flow|Ivermectin 1% Cream + Oral Placebo Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Oral placebo capsules: 1 Capsule once-daily for 12 weeks."
11303845|NCT03075891|OG000|Outcome|Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks."
11303846|NCT03075891|OG001|Outcome|Ivermectin 1% Cream + Oral Placebo Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks.~Oral placebo capsules: 1 Capsule once-daily for 12 weeks."
11303847|NCT03075891|OG000|Outcome|Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks~Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks"
11303848|NCT03075891|OG001|Outcome|Ivermectin 1% Cream + Oral Placebo Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks~Oral placebo capsules: 1 Capsule once-daily for 12 weeks"
11303849|NCT03075891|EG000|Reported Event|Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks~Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks"
11303850|NCT03075891|EG001|Reported Event|Ivermectin 1% Cream + Oral Placebo Capsules|"Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks~Oral placebo capsules: 1 Capsule once-daily for 12 weeks"
11303851|NCT03075904|BG000|Baseline|Cohort 1: ALXN1830|Participants received 5 doses of ALXN1830 10 mg/kg administered weekly.
11303852|NCT03075904|FG000|Participant Flow|Cohort 1: ALXN1830|Participants received 5 doses of ALXN1830 10 mg/kg administered weekly.
11303853|NCT03075904|OG000|Outcome|Cohort 1: ALXN1830|Participants received 5 doses of ALXN1830 10 mg/kg administered weekly.
11303854|NCT03075904|EG000|Reported Event|Cohort 1: ALXN1830|Participants received 5 doses of ALXN1830 10 mg/kg administered weekly.
11303855|NCT03076190|BG000|Baseline|Active Control Group (Health Education)|"Prior to surgery:~Demographics survey~Baseline surveys~Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.~Follow-up questions about the handouts (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)"
11303856|NCT03076190|BG001|Baseline|My Surgical Success Treatment Group|"Prior to surgery:~Demographics survey~Baseline surveys~Intervention:~90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.~audio file~personalized plan that incorporates the information learned in the video.~Follow-up questions about the video (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)~Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation."
11303857|NCT03076190|BG002|Baseline|Total|Total of all reporting groups
11303858|NCT03076190|FG000|Participant Flow|Active Control Group (Health Education)|"Prior to surgery:~Demographics survey~Baseline surveys~Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.~Follow-up questions about the handouts (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)"
11303859|NCT03076190|FG001|Participant Flow|My Surgical Success Treatment Group|"Prior to surgery:~Demographics survey~Baseline surveys~Intervention:~90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.~audio file~personalized plan that incorporates the information learned in the video.~Follow-up questions about the video (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)~Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation."
11303860|NCT03076190|OG000|Outcome|Active Control Group|Health Education Active Control Group
11303861|NCT03076190|OG001|Outcome|My Surgical Success Treatment Group|My Surgical Success Intervention Group
11303862|NCT03076190|OG000|Outcome|Health Education Control|Health Education active control group
11303863|NCT03076190|OG001|Outcome|My Surgical Success|My Surgical Success Intervention Group
11303864|NCT03076190|OG000|Outcome|Responders to Treatment|Characterize responders to My Surgical Success (demographics and psychological correlates)
11303865|NCT03076190|EG000|Reported Event|Active Control Group (Health Education)|"Prior to surgery:~Demographics survey~Baseline surveys~Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.~Follow-up questions about the handouts (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)"
10848446|NCT00289913|OG002|Outcome|VAQTA™/VAQTA™|All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24.
11303866|NCT03076190|EG001|Reported Event|My Surgical Success Treatment Group|"Prior to surgery:~Demographics survey~Baseline surveys~Intervention:~90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.~audio file~personalized plan that incorporates the information learned in the video.~Follow-up questions about the video (detailed above)~Post-surgery:~Daily surveys (detailed above)~Follow-up surveys (2, 4, 8, and 12 weeks after surgery)~Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation."
11303867|NCT03076333|BG000|Baseline|Single Arm: PET/MR|"Each patient will undergo three combined PET/MR scans. The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).~PET/MR: Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates."
11332984|NCT03505190|OG002|Outcome|RO7062931 2.0mg/kg|Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
11303868|NCT03076333|FG000|Participant Flow|Single Arm: PET/MR|"Each patient will undergo three combined PET/MR scans. The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).~PET/MR: Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates."
11303869|NCT03076333|OG000|Outcome|Single Arm: PET/MR|"Each patient will undergo three combined PET/MR scans. The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).~PET/MR: Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates."
11303870|NCT03076333|EG000|Reported Event|Single Arm: PET/MR|"Each patient will undergo three combined PET/MR scans. The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).~PET/MR: Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates."
11332985|NCT03505190|OG003|Outcome|RO7062931 4.0mg/kg|Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
11332986|NCT03505190|OG004|Outcome|Placebo|Participants will receive matching placebo.
11332987|NCT03505190|EG000|Reported Event|RO7062931 0.3mg/kg|Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
11332988|NCT03505190|EG001|Reported Event|RO7062931 1.0mg/kg|Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
11332989|NCT03505190|EG002|Reported Event|RO7062931 2.0mg/kg|Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
11332990|NCT03505190|EG003|Reported Event|RO7062931 4.0mg/kg|Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
11332991|NCT03505190|EG004|Reported Event|Placebo|Participants will receive matching placebo.
11332992|NCT03505593|BG000|Baseline|EFT Placement Using ENVUE System|"Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.~ENVUE System: The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine."
11332993|NCT03505593|FG000|Participant Flow|EFT Placement Using ENVUE System|"Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.~ENVUE System: The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine."
11332994|NCT03505593|OG000|Outcome|EFT Placement Using ENVUE System|Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.
11332995|NCT03505593|EG000|Reported Event|EFT Placement Using ENVUE System|Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.
11332996|NCT03506295|BG000|Baseline|All Participants|"Participants scheduled for cryobiopsy as part of their for routine clinical care had 4 biopsies: 2 with Transbronchial cryobiopsies as a standard of care and 2 with radial probe ultrasound. All participants received both interventions.~Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under fluoroscopy guidance~Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement."
11332997|NCT03506295|FG000|Participant Flow|All Participants|"Each participant received 4 Transbronchial cryobiopsies during a single procedure:~2 cryobiopsies are obtained as a standard of care under fluoroscopy guidance.~The other 2 biopsies are obtained using a radial probe ultrasound under fluoroscopy guidance.~All participants received both inventions during the same procedure.~Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.~fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement."
11332998|NCT03506295|OG000|Outcome|Control|"Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under Fluoroscopy guidance~fluoroscopy: Real-time Fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement."
11332999|NCT03506295|OG001|Outcome|Intervention|"In the intervention arm , radial ultrasound probe will be used in addition to standard of care described above to confirm adequate position of the cryoprobe before transbronchial cryobiopsy is obtained.~Radial Endobronchial Ultrasound Probe: The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size.~Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement."
11333000|NCT03506295|OG000|Outcome|Control|"Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under fluoroscopy guidance~Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement."
11303871|NCT03076359|BG000|Baseline|Standard of Care|"Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303872|NCT03076359|BG001|Baseline|Traditional Healer Support Program|"This group will receive standard of care as described above plus support from a trained traditional healer.~The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services.~Traditional Healer Support Program: Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up"
11303873|NCT03076359|BG002|Baseline|Total|Total of all reporting groups
11303874|NCT03076359|FG000|Participant Flow|Standard of Care|"Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303875|NCT03076359|FG001|Participant Flow|Traditional Healer Support Program|"This group will receive standard of care as described above plus support from a trained traditional healer.~The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services.~Traditional Healer Support Program: Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303876|NCT03076359|OG000|Outcome|Standard of Care|"This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303877|NCT03076359|OG001|Outcome|Traditional Healer Support Program|"This group will receive standard of care as described above plus support from a trained traditional healer.~The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services.~Traditional Healer Support Program: Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303878|NCT03076359|OG000|Outcome|Standard of Care|"Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11333001|NCT03506295|EG000|Reported Event|All Participants|"All participants received both interventions during the same procedure:~2 biopsies via Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under fluoroscopy guidance~2 biopsies via Radial Probe Ultasound - Transbronchial cryobiopsies are obtained with a Radial Probe Ultasound under fluoroscopy guidance"
10971849|NCT00917735|OG000|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
10971850|NCT00917735|OG001|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
11303879|NCT03076359|OG001|Outcome|Traditional Healer Support Program|"This group will receive standard of care as described above. In addition, the investigators will assess an intervention partnership with traditional healer including: community and clinic based support from a trained traditional healer.~The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. In addition, the healer will accompany the patient on all regularly scheduled clinical visits.~Traditional Healer Support Program: Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients."
11303880|NCT03076359|EG000|Reported Event|Standard of Care|"Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303881|NCT03076359|EG001|Reported Event|Traditional Healer Support Program|"This group will receive standard of care as described above plus support from a trained traditional healer.~The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services.~Traditional Healer Support Program: Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients.~Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up."
11303882|NCT03076515|BG000|Baseline|Nerivio Migra Active|Nerivio Migra neurostimulation: transcutaneous electrical stimulation
11303883|NCT03076515|BG001|Baseline|Nerivio Migra Placebo|Sham Nerivio Migra: electrical stimulation- shame mode
11303884|NCT03076515|BG002|Baseline|Total|Total of all reporting groups
11303885|NCT03076515|FG000|Participant Flow|Nerivio Migra Active|Nerivio Migra neurostimulation: transcutaneous electrical stimulation
11303886|NCT03076515|FG001|Participant Flow|Nerivio Migra Placebo|Sham Nerivio Migra: electrical stimulation- shame mode
11303887|NCT03076515|OG000|Outcome|Nerivio Migra Active|Subjects received an active form of Nerivio Migra neurostimulation device
11303888|NCT03076515|OG001|Outcome|Nerivio Migra Placebo|Subjects received a Sham form of Nerivio Migra: neurostimulation device
11303889|NCT03076515|EG000|Reported Event|Nerivio Migra Active|Nerivio Migra neurostimulation: transcutaneous electrical stimulation
11303890|NCT03076515|EG001|Reported Event|Nerivio Migra Placebo|Sham Nerivio Migra: electrical stimulation- shame mode
11303891|NCT03076970|BG000|Baseline|Overall|Single oral doses of Lasmiditan 200 mg, lasmiditan 200 mg placebo and sumatriptan (Imitrex) 200 mg administered as per the dosing sequence in each period.
11303892|NCT03076970|FG000|Participant Flow|Sequence ABC|"Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence:~Period 1 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 2 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 3 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg."
11303893|NCT03076970|FG001|Participant Flow|Sequence ACB|"Single oral doses of lasmiditan co-administered with single oral doses of Sumatriptan (Imitrex) in the following sequence:~Period 1 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 2 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg.~Period 3 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo."
11303894|NCT03076970|FG002|Participant Flow|Sequence BCA|"Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence:~Period 1 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 2 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg.~Period 3 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo."
11303895|NCT03076970|FG003|Participant Flow|Sequence BAC|"Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence:~Period 1 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 2 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 3 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg."
11303896|NCT03076970|FG004|Participant Flow|Sequence CAB|"Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence:~Period 1 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg.~Period 2 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 3 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo."
11303897|NCT03076970|FG005|Participant Flow|Sequence CBA|"Single oral doses of lasmiditan co-administered with single oral doses of Sumatriptan (Imitrex) in the following sequence:~Period 1 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg.~Period 2 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 3 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo."
11303898|NCT03076970|OG000|Outcome|Lasmiditan 200 mg|Participants received single oral tablet of lasmiditan 200 mg with lasmiditan 200 mg placebo.
11303899|NCT03076970|OG001|Outcome|Sumatriptan 100 mg|Participants received single oral tablet of sumatriptan 100 mg with lasmiditan 200 mg placebo.
11303900|NCT03076970|OG002|Outcome|Combination of Lasmiditan and Sumatriptan|Participants received single oral tablet of lasmiditan 200 mg with sumatriptan 100 mg.
10848447|NCT00289913|EG000|Reported Event|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303901|NCT03076970|OG002|Outcome|Combination of Lasmiditan and Sumatriptan|"single oral tablet of each~lasmiditan 200 mg: drug including single placebo tablet~Sumatriptan: drug including single placebo tablet"
11303902|NCT03076970|OG000|Outcome|Lasmiditan Alone|Participants received single oral tablet of lasmiditan 200 mg.
11303903|NCT03076970|OG001|Outcome|Combination of Lasmiditan and Sumatriptan|Participants received single oral tablet of lasmiditan 200 mg with sumatriptan 100 mg.
11303904|NCT03076970|EG000|Reported Event|Lasmiditan 200 mg|Participants received single oral tablet of lasmiditan 200 mg with lasmiditan 200 mg placebo.
11303905|NCT03076970|EG001|Reported Event|Sumatriptan 100 mg|Participants received single oral tablet of sumatriptan 100 mg with lasmiditan 200 mg placebo.
11303906|NCT03076970|EG002|Reported Event|Combination of Lasmiditan and Sumatriptan|Participants received single oral tablet of lasmiditan 200 mg with sumatriptan 100 mg.
11303907|NCT03076983|BG000|Baseline|ICU Patients|"Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303908|NCT03076983|BG001|Baseline|OLV Patients|"Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303909|NCT03076983|BG002|Baseline|Total|Total of all reporting groups
11303910|NCT03076983|FG000|Participant Flow|ICU Patients|"Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303911|NCT03076983|FG001|Participant Flow|OLV Patients|"Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303912|NCT03076983|OG000|Outcome|ICU Patients|"Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303913|NCT03076983|OG001|Outcome|OLV Patients|"Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303914|NCT03076983|EG000|Reported Event|ICU Patients|"Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303915|NCT03076983|EG001|Reported Event|OLV Patients|"Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)~Lung Monitoring with EIT device (PulmoVista 500): Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).~No medical interventions to routine patient care required."
11303916|NCT03076996|BG000|Baseline|Online Support Group|"Intervention content was delivered online through secret Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership."
11303917|NCT03076996|FG000|Participant Flow|Online Support Group|"Intervention content was delivered online through secret Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership."
11303918|NCT03076996|OG000|Outcome|Online Support Group|"Intervention content was delivered online through secret Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership."
11333002|NCT03506347|BG000|Baseline|Vancomycin 15mg/kg IV|"Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.~Vancomycin: Antibiotic"
11303919|NCT03076996|EG000|Reported Event|Online Support Group|"Intervention content was delivered online through secret Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership."
11303920|NCT03077165|BG000|Baseline|Group A|"S42909 dose 100 mg p.o., 50 mg bid~S42909 100 mg: 50 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals."
11303921|NCT03077165|BG001|Baseline|Group B|"S42909 dose 200 mg p.o., 100 mg bid~S42909 200 mg: 50 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals."
11303922|NCT03077165|BG002|Baseline|Group C|"S42909 dose 400 mg p.o., 200 mg bid~S42909 400 mg: 200 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals."
11303923|NCT03077165|BG003|Baseline|Group D|"S42909 dose 800 mg p.o., 400 mg bid~S42909 800 mg: 200 mg Film-coated tablets taken orally,twice a day taken at the end of the morning and at evening meals."
11303924|NCT03077165|BG004|Baseline|Group E|"S42909 dose 1200 mg p.o., 600 mg bid~S42909 1200 mg: 200 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals."
11303925|NCT03077165|BG005|Baseline|Group F|"Placebo p.o. bid~Placebo Oral Tablet: Matching placebo tablets taken orally, twice a day taken at the end of the morning and at evening meals."
11303926|NCT03077165|BG006|Baseline|Total|Total of all reporting groups
11303927|NCT03077165|FG000|Participant Flow|Group A|"S42909 dose 100 mg p.o., 50 mg bid~S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303928|NCT03077165|FG001|Participant Flow|Group B|"S42909 dose 200 mg p.o., 100 mg bid~S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303929|NCT03077165|FG002|Participant Flow|Group C|"S42909 dose 400 mg p.o., 200 mg bid~S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303930|NCT03077165|FG003|Participant Flow|Group D|"S42909 dose 800 mg p.o., 400 mg bid~S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals."
11303931|NCT03077165|FG004|Participant Flow|Group E|"S42909 dose 1200 mg p.o., 600 mg bid~S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303932|NCT03077165|FG005|Participant Flow|Group F|"Placebo p.o. bid~Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals."
11303933|NCT03077165|OG000|Outcome|Group A|"S42909 dose 100 mg p.o., 50 mg bid~S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303934|NCT03077165|OG001|Outcome|Group B|"S42909 dose 200 mg p.o., 100 mg bid~S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303935|NCT03077165|OG002|Outcome|Group C|"S42909 dose 400 mg p.o., 200 mg bid~S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303936|NCT03077165|OG003|Outcome|Group D|"S42909 dose 800 mg p.o., 400 mg bid~S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals."
11303937|NCT03077165|OG004|Outcome|Group E|"S42909 dose 1200 mg p.o., 600 mg bid~S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303938|NCT03077165|OG005|Outcome|Group F|"Placebo p.o. bid~Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals."
11303939|NCT03077165|EG000|Reported Event|Group A|"S42909 dose 100 mg p.o., 50 mg bid~S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303940|NCT03077165|EG001|Reported Event|Group B|"S42909 dose 200 mg p.o., 100 mg bid~S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303941|NCT03077165|EG002|Reported Event|Group C|"S42909 dose 400 mg p.o., 200 mg bid~S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303942|NCT03077165|EG003|Reported Event|Group D|"S42909 dose 800 mg p.o., 400 mg bid~S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals."
11303943|NCT03077165|EG004|Reported Event|Group E|"S42909 dose 1200 mg p.o., 600 mg bid~S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals."
11303944|NCT03077165|EG005|Reported Event|Group F|"Placebo p.o. bid~Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals."
11303945|NCT03077607|BG000|Baseline|A: Talazoparib 0.5 mg + Itraconazole 100 mg BID|Participants received a single oral dose of talazoparib 0.5 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug.
11303946|NCT03077607|BG001|Baseline|B: Talazoparib 1 mg + Rifampin 600 mg QD|Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg QD from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
11303947|NCT03077607|BG002|Baseline|Total|Total of all reporting groups
11303948|NCT03077607|FG000|Participant Flow|A: Talazoparib 0.5 mg + Itraconazole 100 mg BID|Participants received a single oral dose of talazoparib 0.5 milligram (mg) on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg twice daily [BID]) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug.
11303949|NCT03077607|FG001|Participant Flow|B: Talazoparib 1 mg + Rifampin 600 mg QD|Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg once daily (QD) from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
11303950|NCT03077607|OG000|Outcome|Talazoparib 0.5 mg Alone|Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
11303951|NCT03077607|OG001|Outcome|Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID|Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
11303952|NCT03077607|OG000|Outcome|Talazoparib 1.0 mg Alone|Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
11303953|NCT03077607|OG001|Outcome|Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD|Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
11303954|NCT03077607|OG001|Outcome|Itraconazole 100 mg BID Alone|Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
11303955|NCT03077607|OG002|Outcome|Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID|Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
11303956|NCT03077607|OG003|Outcome|Talazoparib 1.0 mg Alone|Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
11303957|NCT03077607|OG004|Outcome|Rifampin 600 mg QD Alone|Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
11303958|NCT03077607|OG005|Outcome|Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD|Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
11303959|NCT03077607|EG000|Reported Event|Talazoparib 0.5 mg Alone|Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
11303960|NCT03077607|EG001|Reported Event|Itraconazole 100 mg BID Alone|Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
11303961|NCT03077607|EG002|Reported Event|Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID|Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
11303962|NCT03077607|EG003|Reported Event|Talazoparib 1.0 mg|Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
10848448|NCT00289913|EG001|Reported Event|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
11303963|NCT03077607|EG004|Reported Event|Rifampin 600 mg QD Alone|Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
11303964|NCT03077607|EG005|Reported Event|Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD|Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
11303965|NCT03077646|BG000|Baseline|Be SMART Alone|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.~Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART"
11303966|NCT03077646|BG001|Baseline|Be SMART + MD Review|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review).~Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.~After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician."
11303967|NCT03077646|BG002|Baseline|Control: TSE Materials|"Parents/guardians in this study group will watch a video Kids and Smoke Don't Mix and receive handouts reviewing information on tobacco smoke exposure (TSE).~Control: TSE: A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line."
11303968|NCT03077646|BG003|Baseline|Total|Total of all reporting groups
11303969|NCT03077646|FG000|Participant Flow|Be SMART Alone|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.~Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART"
11333003|NCT03506347|BG001|Baseline|Vancomycin 500mg Intraosseous|"Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.~Vancomycin: Antibiotic"
11333004|NCT03506347|BG002|Baseline|Total|Total of all reporting groups
11333005|NCT03506347|FG000|Participant Flow|Vancomycin 15mg/kg IV|"Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.~Vancomycin: Antibiotic"
11303970|NCT03077646|FG001|Participant Flow|Be SMART + MD Review|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review).~Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.~After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician."
11303971|NCT03077646|FG002|Participant Flow|Control: TSE Materials|"Parents/guardians in this study group will watch a video Kids and Smoke Don't Mix and receive handouts reviewing information on tobacco smoke exposure (TSE).~Control: TSE: A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line."
11303972|NCT03077646|OG000|Outcome|Be SMART Alone|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.~Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART"
11303973|NCT03077646|OG001|Outcome|Be SMART + MD Review|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review).~Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.~After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician."
11303974|NCT03077646|OG002|Outcome|Control: TSE Materials|"Parents/guardians in this study group will watch a video Kids and Smoke Don't Mix and receive handouts reviewing information on tobacco smoke exposure (TSE).~Control: TSE: A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line."
11303975|NCT03077646|EG000|Reported Event|Be SMART Alone|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.~Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART"
11303976|NCT03077646|EG001|Reported Event|Be SMART + MD Review|"Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review).~Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.~After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician."
10848449|NCT00289913|EG002|Reported Event|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
11303977|NCT03077646|EG002|Reported Event|Control: TSE Materials|"Parents/guardians in this study group will watch a video Kids and Smoke Don't Mix and receive handouts reviewing information on tobacco smoke exposure (TSE).~Control: TSE: A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line."
11303978|NCT03077659|BG000|Baseline|NanoPac® 6 mg/mL|NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303979|NCT03077659|BG001|Baseline|NanoPac® 10 mg/mL|NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303980|NCT03077659|BG002|Baseline|NanoPac® 15 mg/mL|NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303981|NCT03077659|BG003|Baseline|Total|Total of all reporting groups
11303982|NCT03077659|FG000|Participant Flow|NanoPac® 6 mg/mL|NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303983|NCT03077659|FG001|Participant Flow|NanoPac® 10 mg/mL|NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303984|NCT03077659|FG002|Participant Flow|NanoPac® 15 mg/mL|NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303985|NCT03077659|OG000|Outcome|NanoPac® 6 mg/mL|"NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume~NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy."
11303986|NCT03077659|OG001|Outcome|NanoPac® 10 mg/mL|"NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume~NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy."
11303987|NCT03077659|OG002|Outcome|NanoPac® 15 mg/mL|"NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume~NanoPac®: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy."
11303988|NCT03077659|OG000|Outcome|NanoPac® 6 mg/mL|NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
11303989|NCT03077659|OG001|Outcome|NanoPac® 10 mg/mL|NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
11303990|NCT03077659|OG002|Outcome|NanoPac® 15 mg/mL|NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume.
11303991|NCT03077659|EG000|Reported Event|NanoPac® 6 mg/mL|NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303992|NCT03077659|EG001|Reported Event|NanoPac® 10 mg/mL|NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303993|NCT03077659|EG002|Reported Event|NanoPac® 15 mg/mL|NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.
11303994|NCT03077711|BG000|Baseline|Patients With Recurrent UTIs Arm 1|"Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.~Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study)."
11303995|NCT03077711|BG001|Baseline|Patients With Recurrent UTIs Arm 2|"Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.~Trimethoprim: suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study)."
10848450|NCT00289913|EG003|Reported Event|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
11303996|NCT03077711|BG002|Baseline|Total|Total of all reporting groups
11303997|NCT03077711|FG000|Participant Flow|Patients With Recurrent UTIs Arm 1|"Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.~Methenamine hippurate: antiseptic used in the prevention of recurrent urinary tract infections (UTIs)."
11303998|NCT03077711|FG001|Participant Flow|Patients With Recurrent UTIs Arm 2|"Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections (UTIs).~Trimethoprim: suppressive antibiotic."
10848451|NCT00289913|EG004|Reported Event|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
10848452|NCT00289978|BG000|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
10848453|NCT00289978|BG001|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
11303999|NCT03077711|OG000|Outcome|Patients With Recurrent UTIs Arm 1|"Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.~Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs."
11304000|NCT03077711|OG001|Outcome|Patients With Recurrent UTIs Arm 2|"Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.~Trimethoprim: suppressive antibiotic."
11304001|NCT03077711|OG000|Outcome|Patients With Recurrent UTIs Arm 1|"Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.~Methenamine hippurate: antiseptic used in the prevention of recurrent urinary tract infections (UTIs)."
11304002|NCT03077711|OG001|Outcome|Patients With Recurrent UTIs Arm 2|"Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections (UTIs).~Trimethoprim: suppressive antibiotic."
11304003|NCT03077711|EG000|Reported Event|Patients With Recurrent UTIs Arm 1|"Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.~Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs."
11304004|NCT03077711|EG001|Reported Event|Patients With Recurrent UTIs Arm 2|"Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.~Trimethoprim: suppressive antibiotic."
11304005|NCT03077724|BG000|Baseline|Fish Oil|"4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)~Fish oil: Fish oil supplementation"
11304006|NCT03077724|BG001|Baseline|Placebo|"Olive oil supplements~Placebos: Olive Oil capsules"
11304007|NCT03077724|BG002|Baseline|Total|Total of all reporting groups
11304008|NCT03077724|FG000|Participant Flow|Fish Oil|"4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)~Fish oil: Fish oil supplementation"
11304009|NCT03077724|FG001|Participant Flow|Placebo|"Olive oil supplements~Placebos: Olive Oil capsules"
11304010|NCT03077724|OG000|Outcome|Fish Oil|"4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)~Fish oil: Fish oil supplementation"
11304011|NCT03077724|OG001|Outcome|Placebo|"Olive oil supplements~Placebos: Olive Oil capsules"
11304012|NCT03077724|EG000|Reported Event|Fish Oil|"4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)~Fish oil: Fish oil supplementation"
10848454|NCT00289978|BG002|Baseline|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
11304013|NCT03077724|EG001|Reported Event|Placebos|"Olive oil supplements~Placebos: Olive Oil capsules"
11304014|NCT03077893|BG000|Baseline|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11304015|NCT03077893|BG001|Baseline|Sham Group|"Treatment with Inactive (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System"
11304016|NCT03077893|BG002|Baseline|Total|Total of all reporting groups
11304017|NCT03077893|FG000|Participant Flow|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11304018|NCT03077893|FG001|Participant Flow|Sham Group|"Treatment with Inactive (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System"
11304019|NCT03077893|OG000|Outcome|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11304020|NCT03077893|OG001|Outcome|Sham Group|"Treatment with Inactive (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System"
11304021|NCT03077893|EG000|Reported Event|2 Month Lead-in Active Group|Treatment with active Provant Therapy System. Subjects treated with active device during the lead-in part of the study (prior to randomization).
11304022|NCT03077893|EG001|Reported Event|Active Group|Subjects randomized to treat with active Provant Therapy System.
11304023|NCT03077893|EG002|Reported Event|Sham Group|Subjects randomized to treat with sham device.
11304024|NCT03077919|BG000|Baseline|Stellate Ganglion Block (SGB)|"7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).~Ropivacaine: 0.5% ropivacaine"
11304025|NCT03077919|BG001|Baseline|Sham Treatment|"1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.~Sham treatment: preservative-free normal saline"
11304026|NCT03077919|BG002|Baseline|Total|Total of all reporting groups
11304027|NCT03077919|FG000|Participant Flow|Stellate Ganglion Block (SGB)|"7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).~Ropivacaine: 0.5% ropivacaine"
11304028|NCT03077919|FG001|Participant Flow|Sham Treatment|"1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.~Sham treatment: preservative-free normal saline"
11304029|NCT03077919|OG000|Outcome|Stellate Ganglion Block (SGB)|"7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).~Ropivacaine: 0.5% ropivacaine"
11304030|NCT03077919|OG001|Outcome|Sham Treatment|"1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.~Sham treatment: preservative-free normal saline"
11304031|NCT03077919|EG000|Reported Event|Stellate Ganglion Block (SGB)|"7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).~Ropivacaine: 0.5% ropivacaine"
11304032|NCT03077919|EG001|Reported Event|Sham Treatment|"1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.~Sham treatment: preservative-free normal saline"
11333006|NCT03506347|FG001|Participant Flow|Vancomycin 500mg Intraosseous|"Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the intraosseous regional administration (IORA) injection then deflated.~Vancomycin: Antibiotic"
11333007|NCT03506347|OG000|Outcome|Vancomycin 15mg/kg IV|"Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.~Vancomycin: Antibiotic"
11333008|NCT03506347|OG001|Outcome|Vancomycin 500mg Intraosseous|"Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.~Vancomycin: Antibiotic"
11333009|NCT03506347|EG000|Reported Event|Vancomycin 15mg/kg IV|"Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.~Vancomycin: Antibiotic"
11333010|NCT03506347|EG001|Reported Event|Vancomycin 500mg Intraosseous|"Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.~Vancomycin: Antibiotic"
11333011|NCT03506386|BG000|Baseline|Multiple Myeloma Participants|Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.
11333012|NCT03506386|FG000|Participant Flow|Multiple Myeloma Participants|Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.
11333013|NCT03506386|OG000|Outcome|Multiple Myeloma Participants|Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.
11333014|NCT03506386|EG000|Reported Event|Multiple Myeloma Participants|Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.
10848455|NCT00289978|BG003|Baseline|Total|Total of all reporting groups
10848456|NCT00289978|FG000|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
11304033|NCT03078075|BG000|Baseline|Active Medication Combination (AMC)|"injectable extended release naltrexone plus once daily oral extended-release bupropion tablets~Naltrexone: Vivitrol®: Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks~Bupropion: Wellbutrin XL® (Extended release): Bupropion: 450 mg oral dose daily"
11304034|NCT03078075|BG001|Baseline|Matched Placebo (PLB)|"injectable matching placebo plus once-daily oral placebo tablets~Placebo (PLB) Injectable: Placebo: 4 intramuscular injections administered every 3 weeks~Placebo (PLB) Oral: Placebo: once-daily oral placebo tablets"
11304035|NCT03078075|BG002|Baseline|Total|Total of all reporting groups
11304036|NCT03078075|FG000|Participant Flow|Stage 1 Placebo Non-responders Re-randomized to Placebo at Stage 2|Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6, and then re-randomized to Placebo at stage 2.
11304037|NCT03078075|FG001|Participant Flow|Stage 1 Placebo Non-responders Re-randomized to AMC at Stage 2|Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6, and then re-randomized to AMC at stage 2.
11304038|NCT03078075|FG002|Participant Flow|Stage 1 Placebo Non-responders Not Re-randomized at Stage 2|Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6 and then not re-randomized at stage 2, remained in the Placebo arm.
11304039|NCT03078075|FG003|Participant Flow|Stage 1 Placebo Responders Not Re-randomized at Stage 2|Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were responders at week 5 and 6 and then not re-randomized at stage 2, remained in the Placebo arm.
11304040|NCT03078075|FG004|Participant Flow|Stage 1 AMC Remaining on AMC at Stage 2|All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304041|NCT03078075|OG000|Outcome|Stage 1 Placebo|Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7.
11304042|NCT03078075|OG001|Outcome|Stage 1 AMC|Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304043|NCT03078075|OG000|Outcome|Stage 2 Re-Randomized Placebo|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7).
11304044|NCT03078075|OG001|Outcome|Stage 2 Re-Randomized AMC|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)
11304045|NCT03078075|OG002|Outcome|Stage 2 Not Re-Randomized Placebo|Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12).
11304046|NCT03078075|OG003|Outcome|Stage 2 Not Re-Randomized AMC|All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304047|NCT03078075|OG002|Outcome|Stage 2 Re-Randomized Placebo|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7).
11304048|NCT03078075|OG003|Outcome|Stage 2 Re-Randomized AMC|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)
11304049|NCT03078075|OG004|Outcome|Stage 2 Not Re-Randomized Placebo|Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12).
11304050|NCT03078075|OG005|Outcome|Stage 2 Not Re-Randomized AMC|All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304051|NCT03078075|OG000|Outcome|Placebo|Those participants randomized to the Placebo arm in Stage 1
11304052|NCT03078075|OG001|Outcome|AMC (Active Medication Combination Arm)|Those participants who were randomized to the Active Medication Combination arm in Stage 1
10848457|NCT00289978|FG001|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
11304053|NCT03078075|OG000|Outcome|Stage 2 Re-Randomized Placebo|Those participants randomized to the Placebo arm in Stage 2
11304054|NCT03078075|OG001|Outcome|Stage 2 Re-Randomized AMC (Active Medication Combination Arm)|Those participants who were randomized to the Active Medication Combination arm in Stage 2
11304055|NCT03078075|OG001|Outcome|AMC (Active Medication Combination)|Those participants who were randomized to the Active Medication Combination arm in Stage 1
11304056|NCT03078075|EG000|Reported Event|Stage 1 Placebo|Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7.
11304057|NCT03078075|EG001|Reported Event|Stage 1 AMC|Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304058|NCT03078075|EG002|Reported Event|Stage 2 Re-Randomized Placebo|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7).
11304059|NCT03078075|EG003|Reported Event|Stage 2 Re-Randomized AMC|Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)
11304060|NCT03078075|EG004|Reported Event|Stage 2 Not Re-Randomized Placebo|Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12).
11304061|NCT03078075|EG005|Reported Event|Stage 2 Not Re-Randomized AMC|All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12).
11304062|NCT03078127|BG000|Baseline|Sequence A|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), Whole body vibration, Vest, OPEP (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304063|NCT03078127|BG001|Baseline|Sequence B|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), Vest, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304064|NCT03078127|BG002|Baseline|Sequence C|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), OPEP, Whole body vibration, Vest (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304065|NCT03078127|BG003|Baseline|Total|Total of all reporting groups
11304066|NCT03078127|FG000|Participant Flow|Sequence A|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), Whole body vibration, Vest, Oscillatory Positive Expiratory Pressure (OPEP).~(note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304067|NCT03078127|FG001|Participant Flow|Sequence B|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), Vest, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304068|NCT03078127|FG002|Participant Flow|Sequence C|"In this arm, the interventions were performed in the following order:~Baseline (prior to randomization), OPEP, Whole body vibration, Vest (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)"
11304069|NCT03078127|OG000|Outcome|Huff-Cough Alone|"Subjects will provide two huffs (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.~Huff-Cough alone: Subjects will provide two huffs (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs."
11304070|NCT03078127|OG001|Outcome|Oscillatory Positive Expiatory Pressure Device (OPEP)|"Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.~Oscillatory Positive Expiatory Pressure Device: Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes."
11304071|NCT03078127|OG002|Outcome|Whole Body Vibration|"Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.~Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart."
11304072|NCT03078127|OG003|Outcome|High Frequency Chest Wall Oscillatory Vest (HFCWO)|"Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough.~High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough."
11304073|NCT03078127|OG003|Outcome|High Frequency Chest Wall Oscillatory Vest|"Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough.~High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough."
11304074|NCT03078127|EG000|Reported Event|Huff-Cough Alone|"Subjects will provide two huffs (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.~Huff-Cough alone: Subjects will provide two huffs (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs."
11304075|NCT03078127|EG001|Reported Event|Oscillatory Positive Expiatory Pressure Device (OPEP)|"Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.~Oscillatory Positive Expiatory Pressure Device: Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes."
11304076|NCT03078127|EG002|Reported Event|Whole Body Vibration|"Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.~Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart."
11304077|NCT03078127|EG003|Reported Event|High Frequency Chest Wall Oscillatory Vest|"Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough.~High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough."
10848458|NCT00289978|FG002|Participant Flow|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
11304078|NCT03078504|BG000|Baseline|Experimental Arm|"The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics~continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates"
11304079|NCT03078504|FG000|Participant Flow|Experimental Arm|"The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics~continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates"
11304080|NCT03078504|OG000|Outcome|Experimental Arm|"The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics~continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates"
11304081|NCT03078504|EG000|Reported Event|Experimental Arm|"The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics~continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates"
11304082|NCT03078556|BG000|Baseline|Part 1|Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state.
11304083|NCT03078556|BG001|Baseline|Part 2|Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period.
11304084|NCT03078556|BG002|Baseline|Total|Total of all reporting groups
11304085|NCT03078556|FG000|Participant Flow|Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed|Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
11304086|NCT03078556|FG001|Participant Flow|Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed|Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
11304087|NCT03078556|FG002|Participant Flow|Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed|Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
11304088|NCT03078556|FG003|Participant Flow|Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed|Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
11304089|NCT03078556|OG000|Outcome|A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304090|NCT03078556|OG001|Outcome|B: DTG 50 mg/ 3TC 300 mg Monolayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304091|NCT03078556|OG000|Outcome|A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304092|NCT03078556|OG001|Outcome|C: DTG 50 mg/ 3TC 300 mg Bilayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304093|NCT03078556|OG001|Outcome|B: DTG 50 mg/ 3TC 300 mg Monolayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304094|NCT03078556|OG001|Outcome|B: DTG 50 mg/ 3TC 300 mg Bilayer FDC|Participants received a single oral dose of DTG 50mg and 3TC 300mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
10848459|NCT00289978|OG000|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
11304095|NCT03078556|OG000|Outcome|B: DTG 50 mg/ 3TC 300 mg Monolayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304096|NCT03078556|OG001|Outcome|Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed|Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
11304097|NCT03078556|OG000|Outcome|C: DTG 50 mg and 3TC 300 mg Bilayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304098|NCT03078556|OG001|Outcome|Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
11304099|NCT03078556|OG001|Outcome|Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed|Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
11304100|NCT03078556|OG000|Outcome|Part 1- A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304101|NCT03078556|OG001|Outcome|Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304102|NCT03078556|OG002|Outcome|Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed|Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
11304103|NCT03078556|OG003|Outcome|Part 2- A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304104|NCT03078556|OG004|Outcome|Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304105|NCT03078556|OG005|Outcome|Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
11304106|NCT03078556|EG000|Reported Event|Part 1- A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304107|NCT03078556|EG001|Reported Event|Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304108|NCT03078556|EG002|Reported Event|Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed|Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
11304109|NCT03078556|EG003|Reported Event|Part 2- A: DTG 50 mg + EPIVIR 300 mg|Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304110|NCT03078556|EG004|Reported Event|Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
11304111|NCT03078556|EG005|Reported Event|Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed|Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
11304112|NCT03078582|BG000|Baseline|Cohort A (Treatment Naive)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304113|NCT03078582|BG001|Baseline|Cohort B (Previously on Eculizumab)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304114|NCT03078582|BG002|Baseline|Total|Total of all reporting groups
11304115|NCT03078582|FG000|Participant Flow|Cohort A (Treatment Naive)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304116|NCT03078582|FG001|Participant Flow|Cohort B (Previously on Eculizumab)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304117|NCT03078582|OG000|Outcome|Cohort A (Treatment Naive)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304118|NCT03078582|OG001|Outcome|Cohort B (Previously on Eculizumab)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304119|NCT03078582|EG000|Reported Event|Cohort A (Treatment Naive)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304120|NCT03078582|EG001|Reported Event|Cohort B (Previously on Eculizumab)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
11304121|NCT03078595|BG000|Baseline|Von Willebrand Disease Type 2 and 3|Examinations (haematologically and periodontally) of von Willebrand disease patients with type 2 and 3 and healthy controls to evaluate whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm
11304122|NCT03078595|BG001|Baseline|Controls|For each case (VWD) a respective haematologically healthy control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main. Each control is matched to one of the respective cases for sex, age (±5 years), self-reported smoking status (current smoker/non-smoker), number of remaining teeth (±2 teeth), and periodontal diagnosis (gingivitis, chronic or aggressive periodontitis).
11304123|NCT03078595|BG002|Baseline|Total|Total of all reporting groups
11304124|NCT03078595|FG000|Participant Flow|Von Willebrand Disease Type 2 and 3|Examinations (haematologically and periodontally) of von Willebrand disease patients with type 2 and 3 and healthy controls to evaluate whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm
11304125|NCT03078595|FG001|Participant Flow|Controls|For each case (VWD) a respective haematologically healthy control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main. Each control is matched to one of the respective cases for sex, age (±5 years), self-reported smoking status (current smoker/non-smoker), number of remaining teeth (±2 teeth), and periodontal diagnosis (gingivitis, chronic or aggressive periodontitis).
11304126|NCT03078595|OG000|Outcome|Von Willebrand Disease Type 2 and 3|Examinations (haematologically and periodontally) of von Willebrand disease patients with type 2 and 3 and healthy controls to evaluate whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm
11304127|NCT03078595|OG001|Outcome|Controls|For each case (VWD) a respective haematologically healthy control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main. Each control is matched to one of the respective cases for sex, age (±5 years), self-reported smoking status (current smoker/non-smoker), number of remaining teeth (±2 teeth), and periodontal diagnosis (gingivitis, chronic or aggressive periodontitis).
11304128|NCT03078595|EG000|Reported Event|Von Willebrand Disease Type 2 and 3|Examinations (haematologically and periodontally) of von Willebrand disease patients with type 2 and 3 and healthy controls to evaluate whether type 2 and 3 VWD determines an increased susceptibility to gingival bleeding in response to the oral biofilm
11304129|NCT03078595|EG001|Reported Event|Controls|For each case (VWD) a respective haematologically healthy control is recruited from the gingivitis and periodontitis patients of the Department of Periodontology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main. Each control is matched to one of the respective cases for sex, age (±5 years), self-reported smoking status (current smoker/non-smoker), number of remaining teeth (±2 teeth), and periodontal diagnosis (gingivitis, chronic or aggressive periodontitis).
11304130|NCT03078647|BG000|Baseline|Treated on the Suprapatellar|Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)
11304131|NCT03078647|BG001|Baseline|Treated on the Upper Arms|Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)
11304132|NCT03078647|BG002|Baseline|Treated on the Braline|Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
11304133|NCT03078647|BG003|Baseline|Total|Total of all reporting groups
11304134|NCT03078647|FG000|Participant Flow|Treated on the Suprapatellar|Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both left and right sides)
11304135|NCT03078647|FG001|Participant Flow|Treated on the Upper Arms|Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both left and right sides)
11304136|NCT03078647|FG002|Participant Flow|Treated on the Braline|Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both left and right sides)
10848460|NCT00289978|OG001|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
11304137|NCT03078647|OG000|Outcome|Treated on the Suprapatellar|Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)
11304138|NCT03078647|OG001|Outcome|Treated on the Upper Arms|Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)
11304139|NCT03078647|OG002|Outcome|Treated on the Braline|Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
11304140|NCT03078647|EG000|Reported Event|Treated on the Suprapatellar|Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)
11304141|NCT03078647|EG001|Reported Event|Treated on the Upper Arms|Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)
11304142|NCT03078647|EG002|Reported Event|Treated on the Braline|Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
11304143|NCT03078751|BG000|Baseline|Ribociclib + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
11304144|NCT03078751|BG001|Baseline|Placebo + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
11304145|NCT03078751|BG002|Baseline|Total|Total of all reporting groups
11304146|NCT03078751|FG000|Participant Flow|Ribociclib + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
11304147|NCT03078751|FG001|Participant Flow|Placebo + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
11304148|NCT03078751|OG000|Outcome|Ribociclib + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
11304149|NCT03078751|OG001|Outcome|Placebo + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
11304150|NCT03078751|EG000|Reported Event|Ribociclib + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
11304151|NCT03078751|EG001|Reported Event|Placebo + Adjuvant Endocrine Therapy (ET)|Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
11304152|NCT03078816|BG000|Baseline|DBS Active|"All participants will be enrolled in DBS placement and active stimulation. The following components will be used:~Activa PC Primary Cell Neurostimulator - (Model 37601)~Activa RC Rechargeable Neurostimulator - (Model 37612)~Activa SC Single Cell Neurostimulator (Models 37602 and 37603)~DBS Lead - (Model 3387)~DBS Extension - (Models 37085/6)~Patient Programmer - (Model 37642)~Test Stimulator - (Model 3625)~N'Vision Clinician Programmer - (Model 8840)~N'Vision Software Application Card - (Model 8870)~Activa PC Primary Cell Neurostimulator - (Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.~Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques."
11304153|NCT03078816|FG000|Participant Flow|DBS Active|"Participants will have DBS placement and active stimulation.The following components will be used:~Activa PC Primary Cell Neurostimulator(Model 37601)~Activa RC Rechargeable Neurostimulator(Model 37612)~Activa SC Single Cell Neurostimulator(Models 37602 and 37603)~DBS Lead(Model 3387)~DBS Extension(Models 37085/6)~Patient Programmer(Model 37642)~Test Stimulator(Model 3625)~N'Vision Clinician Programmer(Model 8840)~N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.~Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques."
11304154|NCT03078816|OG000|Outcome|DBS Active|"Participants will have DBS placement and active stimulation.The following components will be used:~Activa PC Primary Cell Neurostimulator(Model 37601)~Activa RC Rechargeable Neurostimulator(Model 37612)~Activa SC Single Cell Neurostimulator(Models 37602 and 37603)~DBS Lead(Model 3387)~DBS Extension(Models 37085/6)~Patient Programmer(Model 37642)~Test Stimulator(Model 3625)~N'Vision Clinician Programmer(Model 8840)~N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.~Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques."
11304155|NCT03078816|EG000|Reported Event|DBS Active|"All participants will be enrolled in DBS placement and active stimulation. The following components will be used:~Activa PC Primary Cell Neurostimulator - (Model 37601)~Activa RC Rechargeable Neurostimulator - (Model 37612)~Activa SC Single Cell Neurostimulator (Models 37602 and 37603)~DBS Lead - (Model 3387)~DBS Extension - (Models 37085/6)~Patient Programmer - (Model 37642)~Test Stimulator - (Model 3625)~N'Vision Clinician Programmer - (Model 8840)~N'Vision Software Application Card - (Model 8870)~Activa PC Primary Cell Neurostimulator - (Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.~Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques."
11304156|NCT03078907|BG000|Baseline|Selexipag|Participants received Selexipag which was up-titrated from Day 1 (Week 1) to Week 12 to the individualized highest tolerated dose (HTD) which ranged from 200 microgram (mcg) to 1600 mcg twice daily (BID) orally. The dose was increased in increments of 200 mcg BID, usually at weekly intervals, depending on the dose tolerability. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304157|NCT03078907|BG001|Baseline|Placebo|Participants received one to 8 tablets of 200 (mcg) matching placebo, administered up to a maximum dose up-titrated to 1600 mcg orally twice daily. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304158|NCT03078907|BG002|Baseline|Total|Total of all reporting groups
11304159|NCT03078907|FG000|Participant Flow|Selexipag|Participants received Selexipag which was up-titrated from Day 1 (Week 1) to Week 12 to the individualized highest tolerated dose (HTD) which ranged from 200 microgram (mcg) to 1600 mcg twice daily (BID) orally. The dose was increased in increments of 200 mcg BID, usually at weekly intervals, depending on the dose tolerability. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304160|NCT03078907|FG001|Participant Flow|Placebo|Participants received one to 8 tablets of 200 (mcg) matching placebo, administered up to a maximum dose up-titrated to 1600 mcg orally twice daily. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304161|NCT03078907|OG000|Outcome|Selexipag|Participants received Selexipag which was up-titrated from Day 1 (Week 1) to Week 12 to the individualized highest tolerated dose (HTD) which ranged from 200 microgram (mcg) to 1600 mcg twice daily (BID) orally. The dose was increased in increments of 200 mcg BID, usually at weekly intervals, depending on the dose tolerability. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304162|NCT03078907|OG001|Outcome|Placebo|Participants received one to 8 tablets of 200 (mcg) matching placebo, administered up to a maximum dose up-titrated to 1600 mcg orally twice daily. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304163|NCT03078907|EG000|Reported Event|Selexipag|Participants received Selexipag which was up-titrated from Day 1 (Week 1) to Week 12 to the individualized highest tolerated dose (HTD) which ranged from 200 microgram (mcg) to 1600 mcg twice daily (BID) orally. The dose was increased in increments of 200 mcg BID, usually at weekly intervals, depending on the dose tolerability. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304164|NCT03078907|EG001|Reported Event|Placebo|Participants received one to 8 tablets of 200 (mcg) matching placebo, administered up to a maximum dose up-titrated to 1600 mcg orally twice daily. Up-titration was followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
11304165|NCT03078946|BG000|Baseline|Dexmedetomidine Group (N=30)|Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
11304166|NCT03078946|BG001|Baseline|Morphine With Midazolam (N=30)|Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
11304167|NCT03078946|BG002|Baseline|Total|Total of all reporting groups
11304168|NCT03078946|FG000|Participant Flow|Dexmedetomidine Group (N=30)|Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
11304169|NCT03078946|FG001|Participant Flow|Morphine With Midazolam (N=30)|Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
11304170|NCT03078946|OG000|Outcome|Dexmedetomidine Group (N=30)|Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
11304171|NCT03078946|OG001|Outcome|Morphine With Midazolam (N=30)|Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
11304172|NCT03078946|EG000|Reported Event|Dexmedetomidine Group (N=30)|Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
11304173|NCT03078946|EG001|Reported Event|Morphine With Midazolam (N=30)|Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
11304174|NCT03079375|BG000|Baseline|Usual Care|no pharmaceutical intervention.
11304175|NCT03079375|BG001|Baseline|Basic Intervention|"Medication review~basic intervention: medication review"
11304176|NCT03079375|BG002|Baseline|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304177|NCT03079375|BG003|Baseline|Total|Total of all reporting groups
11304178|NCT03079375|FG000|Participant Flow|Usual Care|no pharmaceutical intervention.
11304179|NCT03079375|FG001|Participant Flow|Basic Intervention|"Medication review~basic intervention: medication review"
11304180|NCT03079375|FG002|Participant Flow|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, general practitioner and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304181|NCT03079375|OG000|Outcome|Usual Care|no pharmaceutical intervention.
11304182|NCT03079375|OG001|Outcome|Basic Intervention|"Medication review~basic intervention: medication review"
11304183|NCT03079375|OG002|Outcome|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304184|NCT03079375|OG002|Outcome|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, general practitioner and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304185|NCT03079375|OG000|Outcome|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, general practitioner and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304186|NCT03079375|OG000|Outcome|Basic Intervention|"Medication review~basic intervention: medication review"
11304187|NCT03079375|OG001|Outcome|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, general practitioner and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304188|NCT03079375|EG000|Reported Event|Usual Care|no pharmaceutical intervention.
11304189|NCT03079375|EG001|Reported Event|Basic Intervention|"Medication review~basic intervention: medication review"
11304190|NCT03079375|EG002|Reported Event|Extended Intervention|"medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home.~extended intervention: medication review, medication interview before discharge and follow-up"
11304191|NCT03079531|BG000|Baseline|Secukinumab Arm|Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
11304192|NCT03079531|FG000|Participant Flow|Secukinumab Arm|Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
11304193|NCT03079531|OG000|Outcome|Secukinumab Arm|Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
11304194|NCT03079531|EG000|Reported Event|Secukinumab Arm|Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
11304195|NCT03080142|BG000|Baseline|Group 1|"Single injection of Exparel~Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks."
11304196|NCT03080142|BG001|Baseline|Group 2|"Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters~Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor."
11304197|NCT03080142|BG002|Baseline|Total|Total of all reporting groups
11304198|NCT03080142|FG000|Participant Flow|Liposomal Bupivacaine Group|"Single injection of Exparel~Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks."
11304199|NCT03080142|FG001|Participant Flow|Ropivacaine Catheter Group|"Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters~Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor."
11304200|NCT03080142|OG000|Outcome|Group 1|"Single injection of Exparel~Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks."
11304201|NCT03080142|OG001|Outcome|Group 2|"Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters~Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor."
11304202|NCT03080142|EG000|Reported Event|Group 1|"Single injection of Exparel~Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks."
11304203|NCT03080142|EG001|Reported Event|Group 2|"Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters~Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor."
11304204|NCT03080454|BG000|Baseline|Sham Doublestim, Then Anodal Doublestim|Crossover design study: Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation).
11304205|NCT03080454|FG000|Participant Flow|Sham Doublestim, Then Anodal Doublestim|Participants underwent 2-3 baseline evaluations, then received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, sham FU measures were collected. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), and again underwent follow-up measures 1 week after the anodal intervention. For all participants, the sham condition preceded the anodal Doublestim condition.
11304206|NCT03080454|OG000|Outcome|Sham Doublestim|Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
11304207|NCT03080454|OG001|Outcome|Anodal Doublestim|Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
11304208|NCT03080454|EG000|Reported Event|Baseline|Prior to any treatment interventions, participants performed 2-3 clinical and objective measure baseline evaluations.
11304209|NCT03080454|EG001|Reported Event|Sham Doublestim (5 Days) + Sham FU (7days)|Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
11304210|NCT03080454|EG002|Reported Event|Anodal Doublestim (5 Days) + Anodal FU (7days)|Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
11304211|NCT03080493|BG000|Baseline|Gabapentin|"Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304212|NCT03080493|BG001|Baseline|Placebo Oral Capsule|"Matched placebo~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Placebo oral capsule: Packaged identical to gabapentin dosing~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304213|NCT03080493|BG002|Baseline|Total|Total of all reporting groups
11304214|NCT03080493|FG000|Participant Flow|Gabapentin|"Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304215|NCT03080493|FG001|Participant Flow|Placebo Oral Capsule|"Matched placebo~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Placebo oral capsule: Packaged identical to gabapentin dosing~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304216|NCT03080493|OG000|Outcome|Gabapentin|"Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304217|NCT03080493|OG001|Outcome|Placebo Oral Capsule|"Matched placebo~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Placebo oral capsule: Packaged identical to gabapentin dosing~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304218|NCT03080493|EG000|Reported Event|Gabapentin|"Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304219|NCT03080493|EG001|Reported Event|Placebo Oral Capsule|"Matched placebo~Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight~Placebo oral capsule: Packaged identical to gabapentin dosing~acetaminophen/codeine and ibuprofen: Over the counter analgesic medications"
11304220|NCT03080961|BG000|Baseline|As Treated Population|Participants that applied VIBLOK at least once
11304221|NCT03080961|FG000|Participant Flow|Treatment Group|46 subjects with a confirmed HSV-2 infection, took external genital skin swabs before and after applying minimally 0.8 pack (~4 ml) of VIBLOK per swab session.
11304222|NCT03080961|OG000|Outcome|During VIBLOK Application|Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
11304223|NCT03080961|OG000|Outcome|Before VIBLOK|Days with HSV detection in the external genital area before application of VIBLOK.
11304224|NCT03080961|OG001|Outcome|After VIBLOK|Days with HSV detection in the external genital area after application of VIBLOK.
11304225|NCT03080961|OG000|Outcome|Before VIBLOK|HSV amount in external genital swabs on days with asymptomatic shedding before applying VIBLOK.
10848461|NCT00289978|OG002|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
10848462|NCT00289978|EG000|Reported Event|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
10971851|NCT00917735|EG000|Reported Event|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
10971852|NCT00917735|EG001|Reported Event|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
10971853|NCT00917852|BG000|Baseline|GORE Conformable TAG® Device Surgical Implant|
10971854|NCT00917852|FG000|Participant Flow|GORE Conformable TAG® Device Surgical Implant|
10971855|NCT00917852|OG000|Outcome|GORE Conformable TAG® Device Surgical Implant|
10971856|NCT00917852|OG000|Outcome|GORE Conformable TAG® Thoracic Endoprosthesis|Gore Conformable TAG Thoracic Endoprosthesis: Endovascular stent graft
10971857|NCT00917852|EG000|Reported Event|CTAG Device Trauma Subjects|
10971858|NCT00917865|BG000|Baseline|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
10971859|NCT00917865|FG000|Participant Flow|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
10971860|NCT00917865|OG000|Outcome|Diagnostic Performance Per Sextant at 4mins Post Injection|Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.
10971861|NCT00917865|OG001|Outcome|Diagnostic Performance Per sextant16mins Post Injetion|"At this time point, the 120 sextants analysed were categorized as followed:~68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative"
10971862|NCT00917865|OG002|Outcome|Diagnostic Performance Per Sextant 28mins Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative"
10971863|NCT00917865|OG003|Outcome|Diagnostic Performance Per Sextant 40minutes Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative"
10971864|NCT00917865|OG000|Outcome|Mean SUV Max at 4 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 4 minutes
10971865|NCT00917865|OG001|Outcome|Mean SUV Maxat 16 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 16 minutes
10971866|NCT00917865|OG002|Outcome|Mean SUV Max at 28 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 28 minutes
10971867|NCT00917865|OG003|Outcome|Mean SUV Maxat 40minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 40 minutes
10971868|NCT00917865|EG000|Reported Event|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
10971869|NCT00918125|BG000|Baseline|Black Patients|Patients who self-identified as African American
10971870|NCT00918125|BG001|Baseline|White Patients|Patients who self-identified as White
10971871|NCT00918125|BG002|Baseline|Total|Total of all reporting groups
10971872|NCT00918125|FG000|Participant Flow|Standard of Care|Patients in this arm received standard of care (counseling from a physician).
10971873|NCT00918125|FG001|Participant Flow|Video Intervention|Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
10971874|NCT00918125|OG000|Outcome|Video|All patients who saw an educational video
10971875|NCT00918125|OG001|Outcome|Standard of Care|Usual care
10971876|NCT00918125|OG000|Outcome|African Americans|African Americans in study from all study arms
10971877|NCT00918125|OG001|Outcome|Whites|Whites in study from all study arms
10971878|NCT00918125|OG000|Outcome|African Americans|All African Americans in study
10971879|NCT00918125|OG001|Outcome|Whites|All Whites in study
10971880|NCT00918125|EG000|Reported Event|All Patients|Patients in this arm received standard of care (counseling from a physician).
10971881|NCT00918138|BG000|Baseline|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
10971882|NCT00918138|BG001|Baseline|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
10971883|NCT00918138|BG002|Baseline|Total|Total of all reporting groups
10971884|NCT00918138|FG000|Participant Flow|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
10971885|NCT00918138|FG001|Participant Flow|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
10971886|NCT00918138|OG000|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
10971887|NCT00918138|OG001|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
10971888|NCT00918138|EG000|Reported Event|Metformin 2000 mg|Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo
10971889|NCT00918138|EG001|Reported Event|Saxagliptin 5 mg + Metformin XR 1500 mg|Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo
11217647|NCT02315170|EG000|Reported Event|Intraocular Injection Guide|"novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye~intraocular injection guide: The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection"
11217648|NCT02315170|EG001|Reported Event|Standard Lid Speculum|"Standard wire eyelid speculum~standard lid speculum: standard wire lid speculum"
11304226|NCT03080961|OG001|Outcome|After VIBLOK|HSV amount in external genital swabs on days with asymptomatic shedding after applying VIBLOK.
11304227|NCT03080961|OG000|Outcome|During VIBLOK Application|Subjects that applied VIBLOK at least once.
11304228|NCT03080961|EG000|Reported Event|During VIBLOK Application|All AEs were recorded in subjects in all subjects applying VIBLOK at least once until 30 days after the last visit to the research clinic.
11304229|NCT03081117|BG000|Baseline|Insulin, Intranasal|"Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose~Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device"
11304230|NCT03081117|BG001|Baseline|Placebo, Intranasal|"Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose~Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device"
11304231|NCT03081117|BG002|Baseline|Total|Total of all reporting groups
11304232|NCT03081117|FG000|Participant Flow|Insulin, Intranasal|"Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose~Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device"
11304233|NCT03081117|FG001|Participant Flow|Placebo, Intranasal|"Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose~Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device"
11304234|NCT03081117|OG000|Outcome|Insulin, Intranasal|"Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose~Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device"
11304235|NCT03081117|OG001|Outcome|Placebo, Intranasal|"Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose~Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device"
11304236|NCT03081117|EG000|Reported Event|Insulin, Intranasal|"Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose~Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device"
11304237|NCT03081117|EG001|Reported Event|Placebo, Intranasal|"Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose~Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device"
11304238|NCT03081884|BG000|Baseline|FACBC PET-CT Imaging|Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
11304239|NCT03081884|FG000|Participant Flow|FACBC PET-CT Imaging|Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
11304240|NCT03081884|OG000|Outcome|FACBC PET-CT Imaging|Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC PET-CT scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
11304241|NCT03081884|OG001|Outcome|Conventional Imaging|Study participants also had conventional imaging (CT or MRI) as part of standard of care.
11304242|NCT03081884|EG000|Reported Event|FACBC PET-CT Imaging|Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.
11304243|NCT03082196|BG000|Baseline|Test Varnish|"Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .~Test varnish: Topical application of test varnish to the teeth 4 times per year."
11304244|NCT03082196|BG001|Baseline|Standard Varnish|"The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.~Standard varnish: Topical application of test varnish to the teeth 4 times per year"
11304245|NCT03082196|BG002|Baseline|Total|Total of all reporting groups
11304246|NCT03082196|FG000|Participant Flow|Test Varnish|"Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .~Test varnish: Topical application of test varnish to the teeth 4 times per year."
11304247|NCT03082196|FG001|Participant Flow|Standard Varnish|"The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.~Standard varnish: Topical application of test varnish to the teeth 4 times per year"
11304248|NCT03082196|OG000|Outcome|Test Varnish|"Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .~Test varnish: Topical application of test varnish to the teeth 4 times per year."
11304249|NCT03082196|OG001|Outcome|Standard Varnish|"The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.~Standard varnish: Topical application of test varnish to the teeth 4 times per year"
11304250|NCT03082196|EG000|Reported Event|Test Varnish|"Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .~Test varnish: Topical application of test varnish to the teeth 4 times per year."
11304251|NCT03082196|EG001|Reported Event|Standard Varnish|"The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.~Standard varnish: Topical application of test varnish to the teeth 4 times per year"
11304252|NCT03082261|BG000|Baseline|All Enrolled Subjects|"All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG.~Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG"
11304253|NCT03082261|FG000|Participant Flow|All Enrolled Subjects|"All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG).~Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG"
11304254|NCT03082261|OG000|Outcome|All Enrolled Subjects|"All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG.~Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG"
11304255|NCT03082261|EG000|Reported Event|All Enrolled Subjects|"All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG.~Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG"
11304256|NCT03082586|BG000|Baseline|Radiochemotherapy 1|"3 Patients will be treated with radiation therapy 57.2 Gy.~radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly"
11304257|NCT03082586|BG001|Baseline|Radiochemotherapy 2|"3 Patients will be treated with radiation therapy 64.4 Gy.~radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304258|NCT03082586|BG002|Baseline|Radiochemotherapy 3|"3 Patients will be treated with radiation therapy 71.6 Gy.~radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304259|NCT03082586|BG003|Baseline|Radiochemotherapy 4|"6 Patients will be treated with radiation therapy 78.8 Gy.~radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304260|NCT03082586|BG004|Baseline|Radiochemotherapy 5|"13 Patients will be treated with radiation therapy 86 Gy.~radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304261|NCT03082586|BG005|Baseline|Radiochemotherapy 6|"3 Patients will be treated with radiation therapy 93.2 Gy.~radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304262|NCT03082586|BG006|Baseline|Total|Total of all reporting groups
11304263|NCT03082586|FG000|Participant Flow|Radiochemotherapy 1|"Patients will be treated with radiation therapy 57.2 Gy.~radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly"
11304264|NCT03082586|FG001|Participant Flow|Radiochemotherapy 2|"Patients will be treated with radiation therapy 64.4 Gy.~radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304265|NCT03082586|FG002|Participant Flow|Radiochemotherapy 3|"Patients will be treated with radiation therapy 71.6 Gy.~radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304266|NCT03082586|FG003|Participant Flow|Radiochemotherapy 4|"Patients will be treated with radiation therapy 78.8 Gy.~radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
10848463|NCT00289978|EG001|Reported Event|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
11304267|NCT03082586|FG004|Participant Flow|Radiochemotherapy 5|"Patients will be treated with radiation therapy 86 Gy.~radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304268|NCT03082586|FG005|Participant Flow|Radiochemotherapy 6|"Patients will be treated with radiation therapy 93.2 Gy.~radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304269|NCT03082586|OG000|Outcome|Arm 1: Radiochemotherapy 1|"Patients will be treated with radiation therapy 57.2 Gy.~radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304270|NCT03082586|OG001|Outcome|Arm 2: Radiochemotherapy 2|"Patients will be treated with radiation therapy 64.4 Gy.~radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304271|NCT03082586|OG002|Outcome|Arm 3：Radiochemotherapy 3|"Patients will be treated with radiation therapy 71.6 Gy.~radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304272|NCT03082586|OG003|Outcome|Arm 4: Radiochemotherapy 4|"Patients will be treated with radiation therapy 78.8 Gy.~radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
10848464|NCT00289978|EG002|Reported Event|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
11304273|NCT03082586|OG004|Outcome|Arm 5: Radiochemotherapy 5|"Patients will be treated with radiation therapy 86 Gy.~radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304274|NCT03082586|OG005|Outcome|Arm 6: Radiochemotherapy 6|"Patients will be treated with radiation therapy 93.2 Gy.~radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;"
11304275|NCT03082586|OG000|Outcome|Arm 1: Radiochemotherapy 1|patients were be treated with radiation therapy 57.2 Gy
11304276|NCT03082586|OG001|Outcome|Arm 2: Radiochemotherapy 2|patients were be treated with radiation therapy 64.4 Gy
11304277|NCT03082586|OG002|Outcome|Arm 3: Radiochemotherapy 3|patients were be treated with radiation therapy 71.6 Gy
11304278|NCT03082586|OG003|Outcome|Arm 4: Radiochemotherapy 4|patients were be treated with radiation therapy 78.8 Gy
11304279|NCT03082586|OG004|Outcome|Arm 5: Radiochemotherapy 5|patients were be treated with radiation therapy 86 Gy
11304280|NCT03082586|OG005|Outcome|Arm 6: Radiochemotherapy 6|patients were be treated with radiation therapy 93.2Gy
11304281|NCT03082586|EG000|Reported Event|Arm 1: Radiochemotherapy 1|"Patients will be treated with radiation therapy 57.2 Gy.~radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 57.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304282|NCT03082586|EG001|Reported Event|Arm 2: Radiochemotherapy 2|"Patients will be treated with radiation therapy 64.4 Gy.~radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304283|NCT03082586|EG002|Reported Event|Arm 3: Radiochemotherapy 3|"Patients will be treated with radiation therapy 71.6 Gy.~radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304284|NCT03082586|EG003|Reported Event|Arm 4: Radiochemotherapy 4|"Patients will be treated with radiation therapy 78.8Gy.~radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304285|NCT03082586|EG004|Reported Event|Arm 5: Radiochemotherapy|"Patients will be treated with radiation therapy 36 Gy.~radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 5: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304286|NCT03082586|EG005|Reported Event|Arm 6: Radiochemotherapy 6|"Patients will be treated with radiation therapy 93.2 Gy.~radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly"
11304287|NCT03082599|BG000|Baseline|Emmetropia Both Eyes (OU) Group|"Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304288|NCT03082599|BG001|Baseline|Nanovision Group|"Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304289|NCT03082599|BG002|Baseline|Total|Total of all reporting groups
11304290|NCT03082599|FG000|Participant Flow|Emmetropia Both Eyes (OU) Group|"Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304291|NCT03082599|FG001|Participant Flow|Nanovision Group|"Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304292|NCT03082599|OG000|Outcome|Emmetropia Both Eyes (OU) Group|"Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304293|NCT03082599|OG001|Outcome|Nanovision Group|"Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304294|NCT03082599|EG000|Reported Event|Emmetropia Both Eyes (OU) Group|"Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304295|NCT03082599|EG001|Reported Event|Nanovision Group|"Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.~Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism."
11304296|NCT03083093|BG000|Baseline|CTEPH Patients|the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
11304297|NCT03083093|BG001|Baseline|Non CTEPH Patients|the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
11304298|NCT03083093|BG002|Baseline|Total|Total of all reporting groups
11304299|NCT03083093|FG000|Participant Flow|CTEPH Patients|the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
11304300|NCT03083093|FG001|Participant Flow|Non CTEPH Patients|the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
11304301|NCT03083093|OG000|Outcome|CTEPH Patients|the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
11304302|NCT03083093|OG001|Outcome|Non CTEPH Patients|the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
11304303|NCT03083093|EG000|Reported Event|CTEPH Patients|the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
11304304|NCT03083093|EG001|Reported Event|Non CTEPH Patients|the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
11304305|NCT03083132|BG000|Baseline|Early-start|"24 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily"
10848465|NCT00289991|BG000|Baseline|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
11304306|NCT03083132|BG001|Baseline|Delayed-start|"12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily~Placebo oral capsule: 1 capsule oral daily"
11304307|NCT03083132|BG002|Baseline|Total|Total of all reporting groups
11304308|NCT03083132|FG000|Participant Flow|Early-start|"24 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily"
11304309|NCT03083132|FG001|Participant Flow|Delayed-start|"12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily~Placebo oral capsule: 1 capsule oral daily"
11304310|NCT03083132|OG000|Outcome|Early-start|"24 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily"
11304311|NCT03083132|OG001|Outcome|Delayed-start|"12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily~Placebo oral capsule: 1 capsule oral daily"
11304312|NCT03083132|EG000|Reported Event|Early-start|"24 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily"
11304313|NCT03083132|EG001|Reported Event|Delayed-start|"12 weeks of oral placebo followed by 12 weeks of modafinil 50 mg oral daily~modafinil 50mg: 1 capsule oral daily~Placebo oral capsule: 1 capsule oral daily"
11304314|NCT03083379|BG000|Baseline|Volumetric Incentive Spirometry|"Incentive Spirometry~Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.~Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.~Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.~Incentive Spirometry therapy and monitoring session will last about 15 minutes"
11304315|NCT03083379|BG001|Baseline|EzPAP® POSITIVE AIRWAY PRESSURE|"EzPAP~EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.~Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.~EzPAP® therapy and monitoring sessions will last about 15 minutes"
11304316|NCT03083379|BG002|Baseline|Total|Total of all reporting groups
11304317|NCT03083379|FG000|Participant Flow|Volumetric Incentive Spirometry|"Incentive Spirometry~Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.~Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.~Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.~Incentive Spirometry therapy and monitoring session will last about 15 minutes"
11333015|NCT03506425|BG000|Baseline|Group 1|"Standard care for 1 month, then standard care and Triheptanoin for 5 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11304318|NCT03083379|FG001|Participant Flow|EzPAP® POSITIVE AIRWAY PRESSURE|"EzPAP~EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.~Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.~EzPAP® therapy and monitoring sessions will last about 15 minutes"
11304319|NCT03083379|OG000|Outcome|Volumetric Incentive Spirometry|"Incentive Spirometry~Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.~Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.~Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.~Incentive Spirometry therapy and monitoring session will last about 15 minutes"
11304320|NCT03083379|OG001|Outcome|EzPAP® POSITIVE AIRWAY PRESSURE|"EzPAP~EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.~Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.~EzPAP® therapy and monitoring sessions will last about 15 minutes"
11304321|NCT03083379|EG000|Reported Event|Volumetric Incentive Spirometry|"Incentive Spirometry~Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.~Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.~Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.~Incentive Spirometry therapy and monitoring session will last about 15 minutes"
11304322|NCT03083379|EG001|Reported Event|EzPAP® POSITIVE AIRWAY PRESSURE|"EzPAP~EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.~Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.~The 10-breath cycle will be repeated three times with respiratory therapist coaching.~Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.~EzPAP® therapy and monitoring sessions will last about 15 minutes"
11304323|NCT03083470|BG000|Baseline|SOR007 0.15%|SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304324|NCT03083470|BG001|Baseline|SOR007 0.3%|SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304325|NCT03083470|BG002|Baseline|SOR007 1.0%|SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304326|NCT03083470|BG003|Baseline|SOR007 2.0%|SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304327|NCT03083470|BG004|Baseline|Ointment Vehicle|SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304328|NCT03083470|BG005|Baseline|Total|Total of all reporting groups
11304329|NCT03083470|FG000|Participant Flow|SOR007 0.15%|SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304330|NCT03083470|FG001|Participant Flow|SOR007 0.3%|SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304331|NCT03083470|FG002|Participant Flow|SOR007 1.0%|SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304332|NCT03083470|FG003|Participant Flow|SOR007 2.0%|SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304333|NCT03083470|FG004|Participant Flow|Ointment Vehicle|SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304334|NCT03083470|OG000|Outcome|SOR007 0.15%|SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304335|NCT03083470|OG001|Outcome|SOR007 0.3%|SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304336|NCT03083470|OG002|Outcome|SOR007 1.0%|SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304337|NCT03083470|OG003|Outcome|SOR007 2.0%|SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304338|NCT03083470|OG004|Outcome|Ointment Vehicle|SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304339|NCT03083470|EG000|Reported Event|SOR007 0.15%|SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304340|NCT03083470|EG001|Reported Event|SOR007 0.3%|SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304341|NCT03083470|EG002|Reported Event|SOR007 1.0%|SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304342|NCT03083470|EG003|Reported Event|SOR007 2.0%|SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304343|NCT03083470|EG004|Reported Event|Ointment Vehicle|SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
11304344|NCT03083483|BG000|Baseline|Bilateral M1, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side.
11304345|NCT03083483|BG001|Baseline|SMA, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex.
11304346|NCT03083483|BG002|Baseline|Sham tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation.
11304347|NCT03083483|BG003|Baseline|Total|Total of all reporting groups
11304348|NCT03083483|FG000|Participant Flow|Bilateral M1, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side.
11304349|NCT03083483|FG001|Participant Flow|SMA, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex.
11304350|NCT03083483|FG002|Participant Flow|Sham tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation.
11304351|NCT03083483|OG000|Outcome|Bilateral M1, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side.
11304352|NCT03083483|OG001|Outcome|SMA, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex.
11304353|NCT03083483|OG002|Outcome|Sham tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation.
11304354|NCT03083483|EG000|Reported Event|Bilateral M1, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side.
11304355|NCT03083483|EG001|Reported Event|SMA, Active tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex.
11304356|NCT03083483|EG002|Reported Event|Sham tDCS|Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation.
11304357|NCT03083639|BG000|Baseline|Regimen A + Regimen B|Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 2.
11304358|NCT03083639|BG001|Baseline|Regimen B + Regimen A|Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 2.
11304359|NCT03083639|BG002|Baseline|Total|Total of all reporting groups
11304360|NCT03083639|FG000|Participant Flow|Regimen A + Regimen B|Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 2.
11304361|NCT03083639|FG001|Participant Flow|Regimen B + Regimen A|Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of Intervention Period 1, followed by at least 6 days of washout period, further followed by esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of Intervention Period 2.
11304362|NCT03083639|OG000|Outcome|Regimen A|Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
11304363|NCT03083639|OG001|Outcome|Regimen B|Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
11304364|NCT03083639|EG000|Reported Event|Regimen A|Esomeprazole 40 mg, capsule, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
11304365|NCT03083639|EG001|Reported Event|Regimen B|Esomeprazole 40 mg, tablet, orally, once under fasted conditions on Day 1 of either Intervention Period 1 or Intervention Period 2.
11304366|NCT03083769|BG000|Baseline|Cohort 1|The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304367|NCT03083769|BG001|Baseline|Cohort 2|The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304368|NCT03083769|BG002|Baseline|Total|Total of all reporting groups
11304369|NCT03083769|FG000|Participant Flow|Cohort 1|The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304370|NCT03083769|FG001|Participant Flow|Cohort 2|The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304371|NCT03083769|OG000|Outcome|Cohort 1|The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304372|NCT03083769|OG001|Outcome|Cohort 2|The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304373|NCT03083769|EG000|Reported Event|Cohort 1|The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
11304374|NCT03083769|EG001|Reported Event|Cohort 2|The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
10848466|NCT00289991|BG001|Baseline|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
11304375|NCT03083847|BG000|Baseline|Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
10848467|NCT00289991|BG002|Baseline|Total|Total of all reporting groups
11217649|NCT02315261|BG000|Baseline|Epidural Group|Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
11217650|NCT02315261|FG000|Participant Flow|Epidural Group|Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
11217651|NCT02315261|OG000|Outcome|Epidural Group|Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
11217652|NCT02315261|EG000|Reported Event|Epidural Group|Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
11217653|NCT02315352|BG000|Baseline|L-PZQ Then Rac-PZQ (Day 1)|L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217654|NCT02315352|BG001|Baseline|Rac-PZQ Then L-PZQ (Day 1)|Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217655|NCT02315352|BG002|Baseline|Total|Total of all reporting groups
11217656|NCT02315352|FG000|Participant Flow|L-PZQ Then Rac-PZQ (Day 1)|Subjects were administered L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217657|NCT02315352|FG001|Participant Flow|Rac-PZQ Then L-PZQ (Day 1)|Subjects were administered Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217658|NCT02315352|FG002|Participant Flow|L-PZQ Then Rac-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® (currently available praziquantel tablet) 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217659|NCT02315352|FG003|Participant Flow|L-PZQ Then Cesol® Then Rac-PZQ (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217660|NCT02315352|FG004|Participant Flow|Rac-PZQ Then Cesol® Then L-PZQ (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217661|NCT02315352|FG005|Participant Flow|Rac-PZQ Then L-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11304376|NCT03083847|BG001|Baseline|Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304377|NCT03083847|BG002|Baseline|Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304378|NCT03083847|BG003|Baseline|Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI|Main Phase - Infectivity Control with one dose of 3.2x10^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
11304379|NCT03083847|BG004|Baseline|Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI|Main Phase - Infectivity Control with 3.2x10^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
11304380|NCT03083847|BG005|Baseline|Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 5x10^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304381|NCT03083847|BG006|Baseline|Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304382|NCT03083847|BG007|Baseline|Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304383|NCT03083847|BG008|Baseline|Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304384|NCT03083847|BG009|Baseline|Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304385|NCT03083847|BG010|Baseline|Total|Total of all reporting groups
11304386|NCT03083847|FG000|Participant Flow|Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 5x10^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304387|NCT03083847|FG001|Participant Flow|Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304388|NCT03083847|FG002|Participant Flow|Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304389|NCT03083847|FG003|Participant Flow|Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304390|NCT03083847|FG004|Participant Flow|Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304391|NCT03083847|FG005|Participant Flow|Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
11304392|NCT03083847|FG006|Participant Flow|Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304393|NCT03083847|FG007|Participant Flow|Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
10971890|NCT00918203|BG000|Baseline|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971891|NCT00918203|BG001|Baseline|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
11304394|NCT03083847|FG008|Participant Flow|Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI|Main Phase - Infectivity Control with one dose of 3.2x10^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
11304395|NCT03083847|FG009|Participant Flow|Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI|Main Phase - Infectivity Control with 3.2x10^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
11304396|NCT03083847|OG000|Outcome|Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 5x10^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
11304397|NCT03083847|OG001|Outcome|Pilot (1b): 1 Dose of 1x10^5 PfSPZ Challenge + Pyrimethamine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
11304398|NCT03083847|OG002|Outcome|Pilot (1d): 1 Dose of 2x10^5 PfSPZ Challenge + Pyrimethamine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
11304399|NCT03083847|OG003|Outcome|Main (2a): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + NF54 CHMI|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (NF54) at 12 weeks after third injection.
11304400|NCT03083847|OG004|Outcome|Main (2b): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + 7G8 CHMI|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
11304401|NCT03083847|OG000|Outcome|Main (3): 3 Doses of 2x10^5 PfSPZ + Chloroquine + 7G8 CHMI|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
11304402|NCT03083847|OG001|Outcome|Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304403|NCT03083847|OG002|Outcome|Pilot (5b): 1 Dose of 2x10^5 PfSPZ Challenge + Chloroquine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection.
11304404|NCT03083847|OG000|Outcome|Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 5x10^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304405|NCT03083847|OG001|Outcome|Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304406|NCT03083847|OG002|Outcome|Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304407|NCT03083847|OG003|Outcome|Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
11304408|NCT03083847|OG004|Outcome|Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304409|NCT03083847|OG005|Outcome|Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304410|NCT03083847|OG006|Outcome|Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304411|NCT03083847|OG007|Outcome|Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304412|NCT03083847|EG000|Reported Event|Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 5x10^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304413|NCT03083847|EG001|Reported Event|Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304414|NCT03083847|EG002|Reported Event|Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
11304415|NCT03083847|EG003|Reported Event|Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 1x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304416|NCT03083847|EG004|Reported Event|Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine|Pilot Phase - 1 injection of 2x10^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
11304417|NCT03083847|EG005|Reported Event|Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
11304418|NCT03083847|EG006|Reported Event|Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304419|NCT03083847|EG007|Reported Event|Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8|Main Phase - 3 monthly doses of 2x10^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
11304420|NCT03083847|EG008|Reported Event|Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI|Main Phase - Infectivity Control with one dose of 3.2x10^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
11304421|NCT03083847|EG009|Reported Event|Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI|Main Phase - Infectivity Control with 3.2x10^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
11304422|NCT03083990|BG000|Baseline|IBI305|"IBI 305 ,3mg/kg, infusion in 90 minutes~IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes"
11304423|NCT03083990|BG001|Baseline|Bevacizumab|"Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes~Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes"
11304424|NCT03083990|BG002|Baseline|Total|Total of all reporting groups
11304425|NCT03083990|FG000|Participant Flow|IBI305|"IBI 305 ,3mg/kg, infusion in 90 minutes~IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes"
11304426|NCT03083990|FG001|Participant Flow|Bevacizumab|"Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes~Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes"
11304427|NCT03083990|OG000|Outcome|IBI305|"IBI 305 ,3mg/kg, infusion in 90 minutes~IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes"
11304428|NCT03083990|OG001|Outcome|Bevacizumab|"Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes~Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes"
11304429|NCT03083990|EG000|Reported Event|IBI305|"IBI 305 ,3mg/kg, infusion in 90 minutes~IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes"
11304430|NCT03083990|EG001|Reported Event|Bevacizumab|"Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes~Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes"
11304431|NCT03084302|BG000|Baseline|Pregnant Women|Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.
11304432|NCT03084302|FG000|Participant Flow|Pregnant Women|Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.
11304433|NCT03084302|OG000|Outcome|Full Cohort|All participants with at least one valid objective data measure
11304434|NCT03084302|OG000|Outcome|Full Cohort|All women with at least one valid assessment of objective activity or sedentary behavior data.
11304435|NCT03084302|EG000|Reported Event|Full Cohort|All participants with at least one valid objective data measure
11304436|NCT03084315|BG000|Baseline|E-Cig Zero Nicotine|"E-Cigarette with no nicotine added~E-Cig Zero Nicotine: E-Cig Zero Nicotine"
11304437|NCT03084315|BG001|Baseline|E-Cig 24mg Nicotine|"E-cigarette with 24mg of nicotine added~E-Cig 24mg Nicotine: E-Cig 24mg Nicotine"
11304438|NCT03084315|BG002|Baseline|Total|Total of all reporting groups
11304439|NCT03084315|FG000|Participant Flow|E-Cig Zero Nicotine|"E-Cigarette with no nicotine added~E-Cig Zero Nicotine: E-Cig Zero Nicotine"
11304440|NCT03084315|FG001|Participant Flow|E-Cig 24mg Nicotine|"E-cigarette with 24mg of nicotine added~E-Cig 24mg Nicotine: E-Cig 24mg Nicotine"
11304441|NCT03084315|OG000|Outcome|E-Cig Zero Nicotine|"E-Cigarette with no nicotine added~E-Cig Zero Nicotine: E-Cig Zero Nicotine"
11304442|NCT03084315|OG001|Outcome|E-Cig 24mg Nicotine|"E-cigarette with 24mg of nicotine added~E-Cig 24mg Nicotine: E-Cig 24mg Nicotine"
11304443|NCT03084315|EG000|Reported Event|E-Cig Zero Nicotine|"E-Cigarette with no nicotine added~E-Cig Zero Nicotine: E-Cig Zero Nicotine"
11304444|NCT03084315|EG001|Reported Event|E-Cig 24mg Nicotine|"E-cigarette with 24mg of nicotine added~E-Cig 24mg Nicotine: E-Cig 24mg Nicotine"
11304445|NCT03084796|BG000|Baseline|Treatment A|"CHF 5259 pMDI, 6.25 μg, 1 inhalation bid; 12.5 μg TDD~CHF 5259 Dose Response: Test one of 4 different doses of CHF 5259"
11304446|NCT03084796|BG001|Baseline|Treatment B|"CHF 5259 pMDI 12.5 μg, 1 inhalation bid; 25 μg TDD~CHF 5259 Dose Response: Test one of 4 different doses of CHF 5259"
11304447|NCT03084796|BG002|Baseline|Treatment C|"CHF 5259 pMDI 12.5 μg, 2 inhalations bid; 50 μg TDD~CHF 5259 Dose Response: Test one of 4 different doses of CHF 5259"
11304448|NCT03084796|BG003|Baseline|Treatment D|"CHF 5259 pMDI 25 μg, 2 inhalations bid; 100 μg TDD~CHF 5259 Dose Response: Test one of 4 different doses of CHF 5259"
11304449|NCT03084796|BG004|Baseline|Treatment E|"Placebo 2 inhalations of CHF 5259 pMDI-matched Placebo bid~Placebo: Placebo Control"
11304450|NCT03084796|BG005|Baseline|Treatment F|"Tiotropium Bromide inhalation powder, 18 μg, SPIRIVA® HandiHaler®, 2 inhalations od of the content of 1 capsule; 18 µg TDD~Tiotropium Bromide Active Control, 18 µg Inhalation Capsule"
11304451|NCT03084796|BG006|Baseline|Total|Total of all reporting groups
11304452|NCT03084796|FG000|Participant Flow|Treatment A|"CHF 5259 pMDI Dose 1, 12.5 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304453|NCT03084796|FG001|Participant Flow|Treatment B|"CHF 5259 pMDI Dose 2, 25 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304454|NCT03084796|FG002|Participant Flow|Treatment C|"CHF 5259 pMDI Dose 3, 50 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304455|NCT03084796|FG003|Participant Flow|Treatment D|"CHF 5259 pMDI Dose 4, 100 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304456|NCT03084796|FG004|Participant Flow|Treatment E|"Placebo Control~Placebo: Placebo Control"
11304457|NCT03084796|FG005|Participant Flow|Treatment F|"Tiotropium Bromide inhalation powder, 18 µg TDD~Tiotropium Bromide Active Control, 18 µg Inhalation Capsule"
11304458|NCT03084796|OG000|Outcome|Treatment A|"CHF 5259 pMDI Dose 1, 12.5 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304459|NCT03084796|OG001|Outcome|Treatment B|"CHF 5259 pMDI Dose 2, 25 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304460|NCT03084796|OG002|Outcome|Treatment C|"CHF 5259 pMDI Dose 3, 50 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304461|NCT03084796|OG003|Outcome|Treatment D|"CHF 5259 pMDI Dose 4, 100 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304462|NCT03084796|OG004|Outcome|Treatment E|"Placebo Control~Placebo: Placebo Control"
11304463|NCT03084796|OG005|Outcome|Treatment F|"Tiotropium Bromide inhalation powder, 18 µg TDD~Tiotropium Bromide Active Control, 18 µg Inhalation Capsule"
11304464|NCT03084796|EG000|Reported Event|Treatment A|"CHF 5259 pMDI Dose 1, 12.5 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304465|NCT03084796|EG001|Reported Event|Treatment B|"CHF 5259 pMDI Dose 2, 25 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304466|NCT03084796|EG002|Reported Event|Treatment C|"CHF 5259 pMDI Dose 3, 50 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304467|NCT03084796|EG003|Reported Event|Treatment D|"CHF 5259 pMDI Dose 4, 100 μg TDD~CHF 5259 Dose Response: Test one of four different doses of CHF 5259"
11304468|NCT03084796|EG004|Reported Event|Treatment E|"Placebo Control~Placebo: Placebo Control"
11304469|NCT03084796|EG005|Reported Event|Treatment F|"Tiotropium Bromide inhalation powder, 18 µg TDD~Tiotropium Bromide Active Control, 18 µg Inhalation Capsule"
11304470|NCT03085017|BG000|Baseline|Ostene|Ostene: OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
11304471|NCT03085017|BG001|Baseline|BoneSeal|BoneSeal: BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
11304472|NCT03085017|BG002|Baseline|Total|Total of all reporting groups
11304473|NCT03085017|FG000|Participant Flow|Ostene|Ostene: OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
11304474|NCT03085017|FG001|Participant Flow|BoneSeal|BoneSeal: BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
11304475|NCT03085017|OG000|Outcome|Ostene|Ostene: OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
11304476|NCT03085017|OG001|Outcome|BoneSeal|BoneSeal: BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
11304477|NCT03085017|EG000|Reported Event|Ostene|Ostene: OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
11304478|NCT03085017|EG001|Reported Event|BoneSeal|BoneSeal: BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
11304479|NCT03085238|BG000|Baseline|M-Trap|M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
11304480|NCT03085238|FG000|Participant Flow|M-Trap|M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
11304481|NCT03085238|OG000|Outcome|M-Trap|M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
11304482|NCT03085238|OG000|Outcome|Platinum Resistant, Recurrent Patients|Tumor cell capture in at least one device in patients determined to be recurrent and platinum-resistant
11304483|NCT03085238|OG001|Outcome|Platinum Sensitive, Recurrent Patients|Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
11304484|NCT03085238|OG002|Outcome|Non-recurrent|Tumor cell capture in at least one device in patients who did not demonstrate recurrence
11304485|NCT03085238|OG003|Outcome|All Recurrent Patients|Tumor cell capture in at least one device in patients determined to be recurrent
11304486|NCT03085238|OG004|Outcome|All Patients|Tumor cell capture in at least one device in all patients
11304487|NCT03085238|OG000|Outcome|M-Trap Platinum Resistant Recurrent|Tumor cell capture in at least one device in patients determined to be recurrent and platinum-resistant
11304488|NCT03085238|OG002|Outcome|Non-recurrent|Tumor cell capture in at least one device in patients determined to be non-recurrent
11304489|NCT03085238|OG003|Outcome|All Recurrent Patients|Tumor cell capture in at least one device in all patients determined to be recurrent
11304490|NCT03085238|OG000|Outcome|M-Trap|M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at the time of surgical debulking.
11304491|NCT03085238|EG000|Reported Event|M-Trap|M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
11304492|NCT03085758|BG000|Baseline|Treatment Arm A|"Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 2 mg/kg"
10971892|NCT00918203|BG002|Baseline|Total|Total of all reporting groups
11304493|NCT03085758|BG001|Baseline|Treatment Arm B|"Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 4 mg/kg"
11304494|NCT03085758|BG002|Baseline|Control Group|"Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab~Placebo: Single i.v. dose of placebo"
11304495|NCT03085758|BG003|Baseline|Total|Total of all reporting groups
11304496|NCT03085758|FG000|Participant Flow|Treatment Arm A|"Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 2 mg/kg"
11304497|NCT03085758|FG001|Participant Flow|Treatment Arm B|"Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 4 mg/kg"
11304498|NCT03085758|FG002|Participant Flow|Control Group|"Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab~Placebo: Single i.v. dose of placebo"
11304499|NCT03085758|OG000|Outcome|Treatment Arm A|"Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 2 mg/kg"
11304500|NCT03085758|OG001|Outcome|Treatment Arm B|"Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 4 mg/kg"
11304501|NCT03085758|OG002|Outcome|Adrecizumab Overall|Treatment Arm A and Treatment Arm B combined
11304502|NCT03085758|OG003|Outcome|Control Group|"Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab~Placebo: Single i.v. dose of placebo"
11304503|NCT03085758|OG000|Outcome|Treatment Arm A|Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab Adrecizumab: Single i.v. dose of 2 mg/kg
11304504|NCT03085758|OG001|Outcome|Treatment Arm B|Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab Adrecizumab: Single i.v. dose of 4 mg/kg
11304505|NCT03085758|OG002|Outcome|Adrecizumab Overall|Treatment Group A and Treatment Group B combined
11304506|NCT03085758|EG000|Reported Event|Treatment Arm A|"Intravenous infusion over approximately 1 hour of single i.v. dose of 2 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 2 mg/kg"
11304507|NCT03085758|EG001|Reported Event|Treatment Arm B|"Intravenous infusion over approximately 1 hour of single i.v. dose of 4 mg/kg Adrecizumab~Adrecizumab: Single i.v. dose of 4 mg/kg"
11304508|NCT03085758|EG002|Reported Event|Control Group|"Intravenous infusion over approximately 1 hour of single i.v. dose of Placebo of Adrecizumab~Placebo: Single i.v. dose of placebo"
11304509|NCT03085797|BG000|Baseline|Placebo|Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304510|NCT03085797|BG001|Baseline|Mepolizumab 100 mg SC|Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304511|NCT03085797|BG002|Baseline|Total|Total of all reporting groups
11304512|NCT03085797|FG000|Participant Flow|Placebo|Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304513|NCT03085797|FG001|Participant Flow|Mepolizumab 100 mg SC|Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304514|NCT03085797|OG000|Outcome|Placebo|Participants were randomized to receive up to 13 subcutaneous (SC) doses of mepolizumab matching placebo every 4 weeks to Week 52 (Wk 52) on top of standard of care (SoC) for nasal polyps (NP) which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304515|NCT03085797|OG001|Outcome|Mepolizumab 100 mg SC|Participants were randomized to receive up to 13 SC doses of mepolizumab 100 milligrams per milliliter (mg/mL) every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray. By design, some randomized participants were eligible to enter a further 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment.
11304516|NCT03085797|EG000|Reported Event|Placebo (Treatment Period)|Participants were randomized to receive up to 13 SC doses of mepolizumab matching placebo every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray.
11304517|NCT03085797|EG001|Reported Event|Mepolizumab 100 mg SC (Treatment Period)|Participants were randomized to receive up to 13 SC doses of mepolizumab 100 mg/mL every 4 weeks to Week 52 on top of SoC for nasal polyps which included daily mometasone furorate nasal spray.
11304518|NCT03085797|EG002|Reported Event|Placebo (Follow-up)|Participants entered in a 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment. Participants received mepolizumab matching placebo during treatment period.
11304519|NCT03085797|EG003|Reported Event|Mepolizumab 100 mg SC (Follow-up)|Participants entered in a 6-month no-treatment follow-up period to assess maintenance of response after cessation of treatment. Participants received mepolizumab 100 mg/mL during treatment period.
11304520|NCT03085836|BG000|Baseline|TAK-438 10 mg Once Daily|TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304521|NCT03085836|BG001|Baseline|TAK-438 20 mg Once Daily|TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304522|NCT03085836|BG002|Baseline|TAK-438 20 mg Twice Daily|TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
11304523|NCT03085836|BG003|Baseline|Total|Total of all reporting groups
11304524|NCT03085836|FG000|Participant Flow|TAK-438 10 mg Once Daily|TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304525|NCT03085836|FG001|Participant Flow|TAK-438 20 mg Once Daily|TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304526|NCT03085836|FG002|Participant Flow|TAK-438 20 mg Twice Daily|TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
11304527|NCT03085836|OG000|Outcome|TAK-438 10 mg Once Daily|TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304528|NCT03085836|OG001|Outcome|TAK-438 20 mg Once Daily|TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304529|NCT03085836|OG002|Outcome|TAK-438 20 mg Twice Daily|TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
11304530|NCT03085836|EG000|Reported Event|TAK-438 10 mg Once Daily|TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304531|NCT03085836|EG001|Reported Event|TAK-438 20 mg Once Daily|TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
11304532|NCT03085836|EG002|Reported Event|TAK-438 20 mg Twice Daily|TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
11304533|NCT03085914|BG000|Baseline|Group A: Epa + Pembrolizumab + mFOLFOX6|Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
11304534|NCT03085914|BG001|Baseline|Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
11304535|NCT03085914|BG002|Baseline|Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
11304536|NCT03085914|BG003|Baseline|Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304537|NCT03085914|BG004|Baseline|Group E: Epa + Pembrolizumab + Cyclophosphamide|Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
11304538|NCT03085914|BG005|Baseline|Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304539|NCT03085914|BG006|Baseline|Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent|Epa (100 mg) oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304540|NCT03085914|BG007|Baseline|Total|Total of all reporting groups
11304541|NCT03085914|FG000|Participant Flow|Group A: Epa + Pembrolizumab +mFOLFOX6|Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
11304542|NCT03085914|FG001|Participant Flow|Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
11304543|NCT03085914|FG002|Participant Flow|Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
11304544|NCT03085914|FG003|Participant Flow|Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304545|NCT03085914|FG004|Participant Flow|Group E: Epa + Pembrolizumab + Cyclophosphamide|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
11304546|NCT03085914|FG005|Participant Flow|Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent|Epa (100mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304547|NCT03085914|FG006|Participant Flow|Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304548|NCT03085914|OG000|Outcome|Group A: Epa + Pembrolizumab + mFOLFOX6|Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
11304549|NCT03085914|OG001|Outcome|Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
11304550|NCT03085914|OG002|Outcome|Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
11304551|NCT03085914|OG003|Outcome|Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304552|NCT03085914|OG004|Outcome|Group E: Epa + Pembrolizumab + Cyclophosphamide|Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
11304553|NCT03085914|OG005|Outcome|Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent|Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304554|NCT03085914|OG006|Outcome|Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent|Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304555|NCT03085914|EG000|Reported Event|Group A: Epa + Pembrolizumab + mFOLFOX6|Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
11304556|NCT03085914|EG001|Reported Event|Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
11304557|NCT03085914|EG002|Reported Event|Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
11304558|NCT03085914|EG003|Reported Event|Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent|Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304559|NCT03085914|EG004|Reported Event|Group E: Epa + Pembrolizumab + Cyclophosphamide|Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
11304560|NCT03085914|EG005|Reported Event|Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent|Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304561|NCT03085914|EG006|Reported Event|Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent|Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
11304562|NCT03085914|EG007|Reported Event|Total|Total
11304563|NCT03085927|BG000|Baseline|Arm 1-Active Music Engagement (Children)|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304564|NCT03085927|BG001|Baseline|Arm II- Audio-Storybooks (Children)|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
11304565|NCT03085927|BG002|Baseline|Arm 1-Active Music Engagement (Parents)|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304566|NCT03085927|BG003|Baseline|Arm II- Audio-Storybooks (Parents)|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
11304567|NCT03085927|BG004|Baseline|Total|Total of all reporting groups
11304568|NCT03085927|FG000|Participant Flow|Arm 1-Active Music Engagement|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304569|NCT03085927|FG001|Participant Flow|Arm II- Audio-Storybooks|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
11304570|NCT03085927|OG000|Outcome|Arm 1-Active Music Engagement|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304571|NCT03085927|OG001|Outcome|Arm II- Audio-Storybooks|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
11304572|NCT03085927|EG000|Reported Event|Arm 1 Parent-Active Music Engagement|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304573|NCT03085927|EG001|Reported Event|Arm II Parent- Audio-Storybooks|"Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.~Audio Storybooks: Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration."
11304574|NCT03085927|EG002|Reported Event|Arm 1 Child-Active Music Engagement|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
11304575|NCT03085927|EG003|Reported Event|Arm II Child-Audio Storybooks|"Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.~Audio Storybooks: Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration."
11304576|NCT03086018|BG000|Baseline|Experimental: Successor Hearing Aid to Juna|The intervention is the new hearing aid which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
11304577|NCT03086018|FG000|Participant Flow|Experimental: Successor Hearing Aid to Juna|The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
11304578|NCT03086018|OG000|Outcome|Successor Hearing Aid to Juna|"The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. The will wear the intervention device for approximately two weeks.~Successor hearing aid to Juna: The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device."
11304579|NCT03086018|OG000|Outcome|Experimental: Successor Hearing Aid to Juna|The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
11304580|NCT03086018|OG000|Outcome|Experimental: Succssor Hearing Aid to Juna|The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
11304581|NCT03086018|EG000|Reported Event|Experimental: Successor Hearing Aid to Juna|The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
11304582|NCT03086057|BG000|Baseline|Strength Based Case Management|"Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.~PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications."
11304583|NCT03086057|BG001|Baseline|Standard of Care:Stage 1|Stage 1: Referral to The Miriam Hospital PrEP Clinic.
11304584|NCT03086057|BG002|Baseline|PrEP Adherence Training and Counseling|"Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.~PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist."
11304585|NCT03086057|BG003|Baseline|Standard of Care: Stage 2|Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
11304586|NCT03086057|BG004|Baseline|Total|Total of all reporting groups
11304587|NCT03086057|FG000|Participant Flow|Strength Based Case Management|"Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.~PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications."
11304588|NCT03086057|FG001|Participant Flow|Standard of Care:Stage 1|Stage 1: Referral to The Miriam Hospital PrEP Clinic.
11304589|NCT03086057|FG002|Participant Flow|PrEP Adherence Training and Counseling|"Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.~PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist."
11304590|NCT03086057|FG003|Participant Flow|Standard of Care: Stage 2|Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
11304591|NCT03086057|OG000|Outcome|Strength Based Case Management|"Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.~PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications."
11304592|NCT03086057|OG001|Outcome|Standard of Care:Stage 1|Stage 1: Referral to The Miriam Hospital PrEP Clinic.
11304593|NCT03086057|OG000|Outcome|PrEP Adherence Training and Counseling|"Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.~PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist."
11304594|NCT03086057|OG001|Outcome|Standard of Care: Stage 2|Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
11304595|NCT03086057|EG000|Reported Event|Strength Based Case Management|"Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.~PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications."
11304596|NCT03086057|EG001|Reported Event|Standard of Care:Stage 1|Stage 1: Referral to The Miriam Hospital PrEP Clinic.
11304597|NCT03086057|EG002|Reported Event|PrEP Adherence Training and Counseling|"Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.~PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist."
11304598|NCT03086057|EG003|Reported Event|Standard of Care: Stage 2|Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
11304599|NCT03086135|BG000|Baseline|Bone-conduction Hearing Device|"The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.~Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea."
11304600|NCT03086135|FG000|Participant Flow|Bone-conduction Hearing Device|"The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.~Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea."
11304601|NCT03086135|OG000|Outcome|Bone-conduction Hearing Device|"The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.~Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea."
11304602|NCT03086135|EG000|Reported Event|Bone-conduction Hearing Device|"The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.~Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea."
11304603|NCT03086213|BG000|Baseline|Per Arm|paravertebral nerve block and intercostal nerve block
11304604|NCT03086213|FG000|Participant Flow|Paravertebral Nerve Block Group|"non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304605|NCT03086213|FG001|Participant Flow|Intercostals Nerve Block Group|"non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304606|NCT03086213|OG000|Outcome|Paravertebral Nerve Block Group|"non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304607|NCT03086213|OG001|Outcome|Intercostals Nerve Block Group|"non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304608|NCT03086213|EG000|Reported Event|Paravertebral Nerve Block Group|"non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304609|NCT03086213|EG001|Reported Event|Intercostals Nerve Block Group|"non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace~Propofol: anaesthetic~Sulfentanyl: anaesthetic~Dexmedetomidine: anaesthetic~Lidocaine: local anaesthetics~Ropivacaine: local anaesthetics"
11304610|NCT03086265|BG000|Baseline|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
11304611|NCT03086265|BG001|Baseline|Endotracheal Tube|Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
11304612|NCT03086265|BG002|Baseline|Total|Total of all reporting groups
11304613|NCT03086265|FG000|Participant Flow|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
11304614|NCT03086265|FG001|Participant Flow|Endotracheal Tube|Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
11304615|NCT03086265|OG000|Outcome|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
11304616|NCT03086265|OG001|Outcome|Endotracheal Tube|Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
11304617|NCT03086265|EG000|Reported Event|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
11304618|NCT03086265|EG001|Reported Event|Endotracheal Tube|Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery).
11304619|NCT03086330|BG000|Baseline|Semaglutide 1.0 mg|Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections.
11304620|NCT03086330|BG001|Baseline|Placebo|Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume.
11304621|NCT03086330|BG002|Baseline|Total|Total of all reporting groups
11304622|NCT03086330|FG000|Participant Flow|Semaglutide 1.0 mg|Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as subcutaneous (s.c.) injections.
11304623|NCT03086330|FG001|Participant Flow|Placebo|Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume.
11304624|NCT03086330|OG000|Outcome|Semaglutide 1.0 mg|Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections.
11304625|NCT03086330|OG001|Outcome|Placebo|Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume.
11304626|NCT03086330|EG000|Reported Event|Semaglutide 1.0 mg|Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections.
11304627|NCT03086330|EG001|Reported Event|Placebo|Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume.
11304628|NCT03086343|BG000|Baseline|Abatacept|500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
11304629|NCT03086343|BG001|Baseline|Upadacitinib 15 mg|One 15 mg tablet taken once per day by mouth for 24 weeks
11304630|NCT03086343|BG002|Baseline|Total|Total of all reporting groups
11304631|NCT03086343|FG000|Participant Flow|Abatacept|500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
11304632|NCT03086343|FG001|Participant Flow|Upadacitinib 15 mg|One 15 mg tablet taken once per day by mouth for 24 weeks
11304633|NCT03086343|OG000|Outcome|Abatacept|500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
11304634|NCT03086343|OG001|Outcome|Upadacitinib 15 mg|One 15 mg tablet taken once per day by mouth for 24 weeks
10848468|NCT00289991|FG000|Participant Flow|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
10848469|NCT00289991|FG001|Participant Flow|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
11304635|NCT03086343|EG000|Reported Event|Abatacept|500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
10848470|NCT00289991|OG000|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
10848471|NCT00289991|OG001|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
11304636|NCT03086343|EG001|Reported Event|Upadacitinib 15 mg|One 15 mg tablet taken once per day by mouth for 24 weeks
11304637|NCT03086356|BG000|Baseline|Dabigatran Etexilate+Idarucizumab|During the first part of the treatment period, dabigatran etexilate was administered alone. All subjects received 220 milligram (mg) dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 1 to 3) and a single 220 mg dose on Day 4. During the second part of the treatment period, after a washout period of 3 days, subjects again received dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 8 to 10) and a single 220 mg dose on Day 11. Idarucizumab (solution for infusion) 2 short infusions of 2.5 grams (g) each, with a 15 minute (min) interval was administered intravenously approximately 2 hours (h) after the last dabigatran etexilate administration.
11304638|NCT03086356|FG000|Participant Flow|Dabigatran Etexilate+Idarucizumab|During the first part of the treatment period, dabigatran etexilate was administered alone. All subjects received 220 milligram (mg) dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 1 to 3) and a single 220 mg dose on Day 4. During the second part of the treatment period, after a washout period of 3 days, subjects again received dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 8 to 10) and a single 220 mg dose on Day 11. Idarucizumab (solution for infusion) 2 short infusions of 2.5 grams (g) each, with a 15 minute (min) interval was administered intravenously approximately 2 hours (h) after the last dabigatran etexilate administration.
11304639|NCT03086356|OG000|Outcome|Dabigatran Etexilate+Idarucizumab|During the first part of the treatment period, dabigatran etexilate was administered alone. All subjects received 220 milligram (mg) dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 1 to 3) and a single 220 mg dose on Day 4. During the second part of the treatment period, after a washout period of 3 days, subjects again received dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 8 to 10) and a single 220 mg dose on Day 11. Idarucizumab (solution for infusion) 2 short infusions of 2.5 grams (g) each, with a 15 minute (min) interval was administered intravenously approximately 2 hours (h) after the last dabigatran etexilate administration.
11304640|NCT03086356|EG000|Reported Event|Dabigatran Etexilate+Idarucizumab|During the first part of the treatment period, dabigatran etexilate was administered alone. All subjects received 220 milligram (mg) dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 1 to 3) and a single 220 mg dose on Day 4. During the second part of the treatment period, after a washout period of 3 days, subjects again received dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 8 to 10) and a single 220 mg dose on Day 11. Idarucizumab (solution for infusion) 2 short infusions of 2.5 grams (g) each, with a 15 minute (min)interval was administered intravenously approximately 2 hours (h) after the last dabigatran etexilate administration.
11304641|NCT03086408|BG000|Baseline|THRIVE|Participants receive THRIVE active nasal oxygen delivery system.
11304642|NCT03086408|BG001|Baseline|Endotracheal Tube or Supraglottic Airway|Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
11304643|NCT03086408|BG002|Baseline|Total|Total of all reporting groups
11304644|NCT03086408|FG000|Participant Flow|THRIVE|Participants receive Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) active nasal oxygen delivery system.
11304645|NCT03086408|FG001|Participant Flow|Endotracheal Tube or Supraglottic Airway|Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
11304646|NCT03086408|OG000|Outcome|THRIVE|Participants receive THRIVE active nasal oxygen delivery system.
11304647|NCT03086408|OG001|Outcome|Endotracheal Tube or Supraglottic Airway|Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
11304648|NCT03086408|EG000|Reported Event|THRIVE|Participants receive THRIVE active nasal oxygen delivery system.
11304649|NCT03086408|EG001|Reported Event|Endotracheal Tube or Supraglottic Airway|Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
11304650|NCT03086447|BG000|Baseline|Lotrafilcon B (Control)|Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
11304651|NCT03086447|BG001|Baseline|Senofilcon C Toric (Test)|Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
11304652|NCT03086447|BG002|Baseline|Total|Total of all reporting groups
11304653|NCT03086447|FG000|Participant Flow|Lotrafilcon B (Control)|Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
11304654|NCT03086447|FG001|Participant Flow|Senofilcon C Toric (Test)|Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
11304655|NCT03086447|OG000|Outcome|Senofilcon C Toric (Test)|Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
11304656|NCT03086447|OG001|Outcome|Lotrafilcon B (Control)|Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
11304657|NCT03086447|EG000|Reported Event|Lotrafilcon B (Control)|Subjects that wore the lotrafilcon B lens throughout the entire duration of the study.
11304658|NCT03086447|EG001|Reported Event|Senofilcon C Toric (Test)|Subjects that wore the senofilcon C toric lens throughout the entire duration of the study.
11304659|NCT03086460|BG000|Baseline|Trial Participants|All trial participants had diagnosed asthma and were randomized to 6 treatments in a cross-over study design.
11304660|NCT03086460|FG000|Participant Flow|Overall Study Group|"Each eligible patient was randomly assigned to one of the 12 treatments sequences. The study had an incomplete cross-over design. Patients were planned to take 4 out of 6 treatments, according to one of 12 possible sequences using a balanced incomplete block randomization scheme. Treatment intervals were separated by 2-week wash-out periods.~For clarity, a summary of study participants who received treatment A, B, C, D, E, and F is presented below as milestones and also as periods."
11304661|NCT03086460|OG000|Outcome|Treatment A|Treatment A, CHF 1531 pMDI: 6 μg TDD
11304662|NCT03086460|OG001|Outcome|Treatment B|Treatment B, CHF 1531 pMDI: 12 μg TDD
11304663|NCT03086460|OG002|Outcome|Treatment C|Treatment C, CHF 1531 pMDI: 24 μg TDD
11304664|NCT03086460|OG003|Outcome|Treatment D|Treatment D, CHF 1531 pMDI: 48 μg TDD
11304665|NCT03086460|OG004|Outcome|Treatment E|Treatment E, Matched placebo
11304666|NCT03086460|OG005|Outcome|Treatment F|Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD
11304667|NCT03086460|OG005|Outcome|Treatment F|"Treatment F,~Formoterol fumarate IS Perforomist®: 40 μg TDD"
11304668|NCT03086460|EG000|Reported Event|Treatment A|Treatment A CHF 1531 pMDI: 6 μg TDD
11304669|NCT03086460|EG001|Reported Event|Treatment B|Treatment B CHF 1531 pMDI: 12 μg TDD
11304670|NCT03086460|EG002|Reported Event|Treatment C|Treatment C CHF 1531 pMDI: 24 μg TDD
11304671|NCT03086460|EG003|Reported Event|Treatment D|Treatment D CHF 1531 pMDI: 48 μg TDD
11304672|NCT03086460|EG004|Reported Event|Treatment E|Treatment E Matched placebo
11304673|NCT03086460|EG005|Reported Event|Treatment F|Treatment F Formoterol fumarate IS Perforomist®: 40 μg TDD
11304674|NCT03086551|BG000|Baseline|Active+Motor Practice, Then Sham+Motor Practice|Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex.
11304675|NCT03086551|BG001|Baseline|Sham+Motor Practice, Then Active+Motor Practice|Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex.
11304676|NCT03086551|BG002|Baseline|Total|Total of all reporting groups
11304677|NCT03086551|FG000|Participant Flow|Active+Motor Practice, Then Sham+Motor Practice|Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex.
11304678|NCT03086551|FG001|Participant Flow|Sham+Motor Practice, Then Active+Motor Practice|Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex.
11304679|NCT03086551|OG000|Outcome|Active+Motor Practice|Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
11304680|NCT03086551|OG001|Outcome|Sham+Motor Practice|Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
11304681|NCT03086551|EG000|Reported Event|Active+Motor Practice|Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
11304682|NCT03086551|EG001|Reported Event|Sham+Motor Practice|Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
11304683|NCT03086707|BG000|Baseline|Cigarette Smokers|"Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years.~Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.~Cigarette: After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette."
11304684|NCT03086707|BG001|Baseline|Never Smokers|"Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.~Subjects will not be allowed to smoke until discharge at Visit 3."
11304685|NCT03086707|BG002|Baseline|Total|Total of all reporting groups
11304686|NCT03086707|FG000|Participant Flow|Cigarette Smokers|"Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years.~Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.~Cigarette: After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette."
11304687|NCT03086707|FG001|Participant Flow|Never Smokers|"Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.~Subjects will not be allowed to smoke until discharge at Visit 3."
11304688|NCT03086707|OG000|Outcome|Cigarette Smokers|"Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years.~Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.~Cigarette: After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette."
11304689|NCT03086707|OG001|Outcome|Never Smokers|"Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.~Subjects will not be allowed to smoke until discharge at Visit 3."
11304690|NCT03086707|OG000|Outcome|Nasal Scraping Method 1|Five study participants underwent nasal scraping using method 1.
11304691|NCT03086707|OG001|Outcome|Nasal Scraping Method 2|Five study participants underwent nasal scraping using method 2.
11304692|NCT03086707|EG000|Reported Event|Cigarette Smokers|"Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years.~Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.~Cigarette: After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette."
11304693|NCT03086707|EG001|Reported Event|Never Smokers|"Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.~Subjects will not be allowed to smoke until discharge at Visit 3."
11304694|NCT03087019|BG000|Baseline|Pembrolizumab + Radiation|"Up to 5 metastatic lesions targeted with radiation~Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab~Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Radiation: Standard use of radiation is administered~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304695|NCT03087019|BG001|Baseline|Pembrolizumab|"Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304696|NCT03087019|BG002|Baseline|Total|Total of all reporting groups
11304697|NCT03087019|FG000|Participant Flow|Pembrolizumab + Radiation|"Up to 5 metastatic lesions targeted with radiation~Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab~Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Radiation: Standard use of radiation is administered~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304698|NCT03087019|FG001|Participant Flow|Pembrolizumab|"Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304699|NCT03087019|OG000|Outcome|Pembrolizumab + Radiation|"Up to 5 metastatic lesions targeted with radiation~Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab~Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Radiation: Standard use of radiation is administered~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304700|NCT03087019|OG001|Outcome|Pembrolizumab|"Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304701|NCT03087019|EG000|Reported Event|Pembrolizumab + Radiation|"Up to 5 metastatic lesions targeted with radiation~Over 5 fractions starting within 7 calendar days following the first dose of pembrolizumab~Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Radiation: Standard use of radiation is administered~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304702|NCT03087019|EG001|Reported Event|Pembrolizumab|"Pembrolizumab will be administered on day 1 of each 21day cycle~Pembrolizumab is delivered intravenously~Pembrolizumab: Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells."
11304703|NCT03087513|BG000|Baseline|Study Intervention|"Initial Arm The study participants will receive10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by 10 ml of Placebo in the second phase.~Cross-over Arm The study participants will receive10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase."
11304704|NCT03087513|FG000|Participant Flow|Initial Arm and Crossover Arm|The study participants will receive either 10ml syringe containing Sugammadex (2mg/kg) or 10 ml Placebo 10 ml in the initial arm and in the crossover arm they will recieve the other drug ( sugammadex or Placebo) Washout period is 3 hours
11304705|NCT03087513|OG000|Outcome|Sugammadex|The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.
11304706|NCT03087513|OG001|Outcome|Placebo|The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
11304707|NCT03087513|OG000|Outcome|Sugammadex Group|The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo (10 ml of 0.9% normal saline) in the second phase.
11304708|NCT03087513|OG001|Outcome|Placebo Group|The study participants will receive a 10 ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
11304709|NCT03087513|OG000|Outcome|Sugammedex Group|The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo (10 ml 0.9% normal saline) in the second phase.
11304710|NCT03087513|OG000|Outcome|Sugammadex Group|The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo (10 ml 0.9% normal saline) in the second phase.
11304711|NCT03087513|OG001|Outcome|Placebo Group|The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
11304712|NCT03087513|OG000|Outcome|Sugammadex|The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml in the second phase.
11304713|NCT03087513|OG001|Outcome|Placebo|The study participants will receive a 10ml syringe containing placebo in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
11304714|NCT03087513|EG000|Reported Event|Sugammadex Group|The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo (10 ml 0.9% normal saline) in the second phase.
11304715|NCT03087513|EG001|Reported Event|Placebo Group|The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
11304716|NCT03087604|BG000|Baseline|Traditional Technique Group|"In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine"
11304717|NCT03087604|BG001|Baseline|Electric Stimulation Group|"In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters"
11304718|NCT03087604|BG002|Baseline|Total|Total of all reporting groups
11304719|NCT03087604|FG000|Participant Flow|Traditional Technique Group|"In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine"
11335865|NCT03557801|FG000|Participant Flow|Standard of Care Mammography|"Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.~Standard of Care Mammography: Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol."
11304720|NCT03087604|FG001|Participant Flow|Electric Stimulation Group|"In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters"
11304721|NCT03087604|OG000|Outcome|Traditional Technique Group|"In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine"
11304722|NCT03087604|OG001|Outcome|Electric Stimulation Group|"In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters"
11304723|NCT03087604|EG000|Reported Event|Traditional Technique Group|"In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine"
11304724|NCT03087604|EG001|Reported Event|Electric Stimulation Group|"In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation~Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.~Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters"
11304725|NCT03087643|BG000|Baseline|Passive Mobilization - PM|"Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.~Passive mobilization - PM"
11304726|NCT03087643|BG001|Baseline|Control Group - Ctrl|Participants will receive ther standard therapies.
11304727|NCT03087643|BG002|Baseline|Total|Total of all reporting groups
11304728|NCT03087643|FG000|Participant Flow|Passive Mobilization - PM|"Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.~Passive mobilization - PM"
11304729|NCT03087643|FG001|Participant Flow|Control Group - Ctrl|Participants will receive ther standard therapies.
11304730|NCT03087643|OG000|Outcome|Passive Mobilization - PM|"Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.~Passive mobilization - PM"
11304731|NCT03087643|OG001|Outcome|Control Group - Ctrl|Participants will receive ther standard therapies.
11304732|NCT03087643|EG000|Reported Event|Passive Mobilization - PM|"Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.~Passive mobilization - PM"
11304733|NCT03087643|EG001|Reported Event|Control Group - Ctrl|Participants will receive ther standard therapies.
11304734|NCT03087786|BG000|Baseline|Nicotine Bitartrate 4mg Lozenge|"Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Bitartrate Lozenge 4mg: Test Product"
11304735|NCT03087786|BG001|Baseline|Nicotine Polacrilex 4mg Lozenge|"Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Polacrilex 4Mg Lozenge: Active Comparator"
11304736|NCT03087786|BG002|Baseline|Total|Total of all reporting groups
11304737|NCT03087786|FG000|Participant Flow|Nicotine Bitartrate 4mg Lozenge|"Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Bitartrate Lozenge 4mg: Test Product"
11304738|NCT03087786|FG001|Participant Flow|Nicotine Polacrilex 4mg Lozenge|"Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Polacrilex 4Mg Lozenge: Active Comparator"
11304739|NCT03087786|OG000|Outcome|Nicotine Bitartrate 4mg Lozenge|"Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Bitartrate Lozenge 4mg: Test Product"
11304740|NCT03087786|OG001|Outcome|Nicotine Polacrilex 4mg Lozenge|"Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Polacrilex 4Mg Lozenge: Active Comparator"
11304741|NCT03087786|EG000|Reported Event|Nicotine Bitartrate 4mg Lozenge|"Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Bitartrate Lozenge 4mg: Test Product"
11304742|NCT03087786|EG001|Reported Event|Nicotine Polacrilex 4mg Lozenge|"Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days~Nicotine Polacrilex 4Mg Lozenge: Active Comparator"
11304743|NCT03087851|BG000|Baseline|6-month Group|Treated with zoledronate 5 mg
11304744|NCT03087851|BG001|Baseline|9-months Group|Treated with zoledronate 5 mg
11304745|NCT03087851|BG002|Baseline|Observation Group|Treated with zoledronate 5 mg
11304746|NCT03087851|BG003|Baseline|Total|Total of all reporting groups
11304747|NCT03087851|FG000|Participant Flow|6-month Group|"Zoledronate: administrated at baseline.~Zoledronate re-adminisrated:~If p-C-terminal telopeptide of type 1 collagen (p-CTX) increases above 1.26 ug/l or bone mineral density (BMD) decreases more than 5% at any site."
11304748|NCT03087851|FG001|Participant Flow|9-months Group|"Zoledronate: administrated depending on increase in p-CTX (above 1.26 ug/l) or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 3.~Zoledronate re-administrated:~If p-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site."
11304749|NCT03087851|FG002|Participant Flow|Observation Group|"Zoledronate: administrated depending on increase in p-CTX (above 1.26 ug/l), decrease in BMD (more than 5%), or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 6.~Zoledronate re-administrated:~If p-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site."
11304750|NCT03087851|OG000|Outcome|6-month Group|n=20
11304751|NCT03087851|OG001|Outcome|9-months Group|n=20
11304752|NCT03087851|OG002|Outcome|Observation Group|n=21
11304753|NCT03087851|EG000|Reported Event|6-month Group|"Zoledronate: administrated at baseline.~Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site."
11304754|NCT03087851|EG001|Reported Event|9-months Group|"Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l) or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 3.~Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site."
11304755|NCT03087851|EG002|Reported Event|Observation Group|"Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l), decrease in BMD (more than 5% at any site), or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 6.~Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site."
11304756|NCT03088267|BG000|Baseline|Overall Study|"Open label phase: amphetamine extended-release oral suspension, 2.5 mg/mL at optimal dose~Double blind phase:~A single dose of amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM, or placebo extended-release oral suspension: 6, 7 or 8 mL PO"
11304757|NCT03088267|FG000|Participant Flow|Sequence: AMPH EROS/Placebo|Patients optimized on open label dose of AMPH EROS. Randomized to optimized dose of AMPH EROS for 1 day. Laboratory classroom assessment takes place. Then crossover to placebo for 4-5 days followed by second laboratory classroom assessment.
11304758|NCT03088267|FG001|Participant Flow|Sequence: Placebo/AMPH EROS|Patients optimized on open label dose of AMPH EROS. Randomized to placebo for 1 day. Laboratory classroom assessment takes place. Then crossover to optimized dose of AMPH EROS for 4-5 days followed by second laboratory classroom assessment.
11304759|NCT03088267|OG000|Outcome|Active Treatment|"Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM~amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO~Placebo extended-release oral suspension: 6, 7 or 8 mL PO"
11304760|NCT03088267|OG001|Outcome|Placebo Treatment|"Double blind placebo, 6, 7 or 8 mL po QAM~amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO~Placebo extended-release oral suspension: 6, 7 or 8 mL PO"
11304761|NCT03088267|EG000|Reported Event|AMPH EROS: Open Label Phase|All AEs reported are from the open-label dose optimization phase with AMPH EROS. The open-label dose optimization phase preceded the crossover portion of the study.
11304762|NCT03088267|EG001|Reported Event|Crossover Phase: AMPH EROS|These AEs occurred during the crossover phase of the study.
11304763|NCT03088267|EG002|Reported Event|Crossover Phase: Placebo|These AEs occurred during the crossover phase of the study.
11304764|NCT03088345|BG000|Baseline|Vasopressin, Arginine|"Patients randomized to this arm will receive a continuous arginine vasopressin infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Vasopressin, Arginine: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304765|NCT03088345|BG001|Baseline|Placebo|"Patients randomized to this arm will receive a continuous normal saline infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Placebos: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304766|NCT03088345|BG002|Baseline|Total|Total of all reporting groups
11304767|NCT03088345|FG000|Participant Flow|Vasopressin, Arginine|"Patients randomized to this arm will receive a continuous arginine vasopressin infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Vasopressin, Arginine: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304768|NCT03088345|FG001|Participant Flow|Placebo|"Patients randomized to this arm will receive a continuous normal saline infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Placebos: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304769|NCT03088345|OG000|Outcome|Vasopressin, Arginine|"Patients randomized to this arm will receive a continuous arginine vasopressin infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Vasopressin, Arginine: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11333016|NCT03506425|BG001|Baseline|Group 2|"Standard care and Triheptanoin for 6 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333017|NCT03506425|BG002|Baseline|Group 3|Healthy controls for biomarkers
11333018|NCT03506425|BG003|Baseline|Total|Total of all reporting groups
11333019|NCT03506425|FG000|Participant Flow|Group 1|"Standard care for 1 month, then standard care and Triheptanoin for 5 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11304770|NCT03088345|OG001|Outcome|Placebo|"Patients randomized to this arm will receive a continuous normal saline infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Placebos: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304771|NCT03088345|EG000|Reported Event|Vasopressin, Arginine|"Patients randomized to this arm will receive a continuous arginine vasopressin infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Vasopressin, Arginine: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304772|NCT03088345|EG001|Reported Event|Placebo|"Patients randomized to this arm will receive a continuous normal saline infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.~Placebos: Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period."
11304773|NCT03088748|BG000|Baseline|Smith & Nephew Journey II PCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty~Journey II posterior cruciate retaining total knee arthroplasty"
11304774|NCT03088748|BG001|Baseline|Smith & Nephew Journey II BCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty~Journey II posterior bi-cruciate retaining total knee arthroplasty"
11304775|NCT03088748|BG002|Baseline|Total|Total of all reporting groups
11304776|NCT03088748|FG000|Participant Flow|Smith & Nephew Journey II PCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty~Journey II posterior cruciate retaining total knee arthroplasty"
11304777|NCT03088748|FG001|Participant Flow|Smith & Nephew Journey II BCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty~Journey II posterior bi-cruciate retaining total knee arthroplasty"
11304778|NCT03088748|OG000|Outcome|Smith & Nephew Journey II PCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty~Journey II posterior cruciate retaining total knee arthroplasty"
11304779|NCT03088748|OG001|Outcome|Smith & Nephew Journey II BCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty~Journey II posterior bi-cruciate retaining total knee arthroplasty"
11304780|NCT03088748|EG000|Reported Event|Smith & Nephew Journey II PCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty~Journey II posterior cruciate retaining total knee arthroplasty"
11304781|NCT03088748|EG001|Reported Event|Smith & Nephew Journey II BCR TKA|"Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty~Journey II posterior bi-cruciate retaining total knee arthroplasty"
11304782|NCT03088800|BG000|Baseline|Oral Ibuprofen|"Oral Ibuprofen at 10mg/kg dose and placebo of equal volume~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose"
11304783|NCT03088800|BG001|Baseline|Oral APAP|"Oral APAP at 15 mg/kg and placebo of equal volume~APAP: Oral APAP at 15mg/kg dose"
11304784|NCT03088800|BG002|Baseline|Oral Ibuprofen and Oral APAP|"Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose~APAP: Oral APAP at 15mg/kg dose"
11304785|NCT03088800|BG003|Baseline|Total|Total of all reporting groups
11304786|NCT03088800|FG000|Participant Flow|Oral Ibuprofen|"Oral Ibuprofen at 10mg/kg dose and placebo of equal volume~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose"
11304787|NCT03088800|FG001|Participant Flow|Oral APAP|"Oral APAP at 15 mg/kg and placebo of equal volume~APAP: Oral APAP at 15mg/kg dose"
11304788|NCT03088800|FG002|Participant Flow|Oral Ibuprofen and Oral APAP|"Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose~APAP: Oral APAP at 15mg/kg dose"
10971893|NCT00918203|FG000|Participant Flow|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle~Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants who experience progressive disease may cross over to olaratumab monotherapy.~Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours~carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
11304789|NCT03088800|OG000|Outcome|Oral Ibuprofen|"Oral Ibuprofen at 10mg/kg dose and placebo of equal volume~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose"
11304790|NCT03088800|OG001|Outcome|Oral APAP|"Oral APAP at 15 mg/kg and placebo of equal volume~APAP: Oral APAP at 15mg/kg dose"
11304791|NCT03088800|OG002|Outcome|Oral Ibuprofen and Oral APAP|"Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose~APAP: Oral APAP at 15mg/kg dose"
11304792|NCT03088800|EG000|Reported Event|Oral Ibuprofen|"Oral Ibuprofen at 10mg/kg dose and placebo of equal volume~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose"
11304793|NCT03088800|EG001|Reported Event|Oral APAP|"Oral APAP at 15 mg/kg and placebo of equal volume~APAP: Oral APAP at 15mg/kg dose"
11304794|NCT03088800|EG002|Reported Event|Oral Ibuprofen and Oral APAP|"Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.~Ibuprofen: Oral Ibuprofen at 10 mg/kg dose~APAP: Oral APAP at 15mg/kg dose"
11304795|NCT03088917|BG000|Baseline|Re-evaluated Lost to Follow-up Patients|Invited lost to follow-up patients who were seen at the outpatient clinic.
11304796|NCT03088917|FG000|Participant Flow|Invited Lost to Follow-up Patients|Alive patients who were anti-HCV and/or HCV RNA positive in the period 2000-2015 who have not been treated and were residing in the Netherlands, were invited for re-evaluation at the outpatient clinic.
11304797|NCT03088917|OG000|Outcome|RNA-positive Re-evaluated Lost to Follow-up Patients|LTFU patients who were still RNA-positive at the re-evaluation visit.
11304798|NCT03088917|OG000|Outcome|Re-evaluated Lost to Follow-up Patients|Invited lost to follow-up patients who were seen at the outpatient clinic.
11304799|NCT03088917|OG000|Outcome|RNA-positive Re-evaluated Lost to Follow-up Patients|RNA-positive patients with a previous fibrosis measurement.
11304800|NCT03088917|EG000|Reported Event|Treated Patients|RNA-positive patients who received treatment with interferon-free direct antiviral regimens.
11304801|NCT03089047|BG000|Baseline|Rejuvenated RBC Transfusion|"Washed and Rejuvenated autologous blood~Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations."
11304802|NCT03089047|BG001|Baseline|Standard RBC Transfusion|"Washed autologous blood (so as to maintain equivalent unit volume and Hct)~Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm"
11304803|NCT03089047|BG002|Baseline|Total|Total of all reporting groups
11304804|NCT03089047|FG000|Participant Flow|Rejuvenated RBC Transfusion|"Washed and Rejuvenated autologous blood~Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations."
11304805|NCT03089047|FG001|Participant Flow|Standard RBC Transfusion|"Washed autologous blood (so as to maintain equivalent unit volume and Hct)~Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm"
11304806|NCT03089047|OG000|Outcome|Rejuvenated RBC Transfusion|"Washed and Rejuvenated autologous blood~Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations."
11304807|NCT03089047|OG001|Outcome|Standard RBC Transfusion|"Washed autologous blood (so as to maintain equivalent unit volume and Hct)~Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm"
11304808|NCT03089047|EG000|Reported Event|Rejuvenated RBC Transfusion|"Washed and Rejuvenated autologous blood~Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations."
11304809|NCT03089047|EG001|Reported Event|Standard RBC Transfusion|"Washed autologous blood (so as to maintain equivalent unit volume and Hct)~Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm"
11304810|NCT03089216|BG000|Baseline|Combined Bleaching(2x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304811|NCT03089216|BG001|Baseline|Combined Bleaching(1x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304812|NCT03089216|BG002|Baseline|Combined Bleaching(1x20) With Arginine|one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304813|NCT03089216|BG003|Baseline|Combined Bleaching(2x20) With Arginine|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304814|NCT03089216|BG004|Baseline|Total|Total of all reporting groups
11304815|NCT03089216|FG000|Participant Flow|Combined Bleaching(2x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304816|NCT03089216|FG001|Participant Flow|Combined Bleaching(1x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304817|NCT03089216|FG002|Participant Flow|Combined Bleaching(1x20) With Arginine|one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304818|NCT03089216|FG003|Participant Flow|Combined Bleaching(2x20) With Arginine|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304819|NCT03089216|OG000|Outcome|Combined Bleaching(2x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304820|NCT03089216|OG001|Outcome|Combined Bleaching(1x20)|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
11304821|NCT03089216|OG002|Outcome|Combined Bleaching(1x20) With Arginine|one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304822|NCT03089216|OG003|Outcome|Combined Bleaching(2x20) With Arginine|two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment.
11304823|NCT03089216|OG000|Outcome|Combined Bleaching(2x20)|"In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide~Combined Bleaching(2x20): one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks."
11304824|NCT03089216|OG001|Outcome|Combined Bleaching(2x20) With Arginine|"Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.~Combined Bleaching(2x20) with arginine: one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.~8% arginine and calcium carbonate: using during all the treatment."
11304825|NCT03089216|OG002|Outcome|Combined Bleaching(1x20)|"In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide~Combined Bleaching (1x20): one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks."
11304826|NCT03089216|OG003|Outcome|Combined Bleaching(1x20) With Arginine|"Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.~Combined Bleaching(1x20) with arginine: one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.~8% arginine and calcium carbonate: using during all the treatment."
11304827|NCT03089216|EG000|Reported Event|Combined Bleaching(2x20)|"In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide~Combined Bleaching(2x20): one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks."
11304828|NCT03089216|EG001|Reported Event|Combined Bleaching(2x20) With Arginine|"Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.~Combined Bleaching(2x20) with arginine: one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.~8% arginine and calcium carbonate: using during all the treatment."
11304829|NCT03089216|EG002|Reported Event|Combined Bleaching(1x20)|"In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide~Combined Bleaching (1x20): one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks."
11304830|NCT03089216|EG003|Reported Event|Combined Bleaching(1x20) With Arginine|"Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.~Combined Bleaching(1x20) with arginine: one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.~8% arginine and calcium carbonate: using during all the treatment."
11304831|NCT03089580|BG000|Baseline|Intense Pulsed Light Treatment|"Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.~Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.~Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study."
11304832|NCT03089580|FG000|Participant Flow|Intense Pulsed Light Treatment|"Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.~Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.~Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study."
11304833|NCT03089580|OG000|Outcome|Intense Pulsed Light Treatment|"Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.~Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.~Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study."
11304834|NCT03089580|OG001|Outcome|Sham Treatment|"Participants had one eye randomized to receive the intense pulsed light (IPL) therapy treatment in the right or left eye, while their other eye received the sham treatment. 14 eyes received IPL, and 14 eyes received the sham treatment. Throughout the study, the IPL treatment eye was always the same for each individual.~Participants received approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level was based on skin type. IPL was administered 4 times throughout the study.~Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants received a total of 4 treatments over the course of the study."
11304835|NCT03089580|EG000|Reported Event|Intense Pulsed Light Treatment|"Participants will have one eye randomized to receive the intense pulsed light (IPL) therapy treatment and will receive the sham treatment in their other eye.~Participants will receive approximately 15 light spots to areas around the eye, lower eyelid, cheek, side of the nose and temple. The energy level will be based on skin type. IPL will be administered 4 times throughout the study.~Intense Pulsed Light Therapy: Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants will receive a total of 4 treatments over the course of the study."
11304836|NCT03089580|EG001|Reported Event|Sham Treatment|"Participants will have the other eye randomized to receive a sham treatment. The sham treatment will be conducted by placing the intense pulsed light (IPL) device to approximately 15 areas around the eye, lower eyelid, cheek, side of nose and temple without delivery of the light. The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.~Sham Treatment: The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study."
11304837|NCT03089697|BG000|Baseline|Placebo|"To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)~Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304838|NCT03089697|BG001|Baseline|N-Rephasin® SAL200|"To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.~N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304839|NCT03089697|BG002|Baseline|Total|Total of all reporting groups
11304840|NCT03089697|FG000|Participant Flow|Placebo|"To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)~Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304841|NCT03089697|FG001|Participant Flow|N-Rephasin® SAL200|"To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.~N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304842|NCT03089697|OG000|Outcome|Placebo|"To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)~Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304843|NCT03089697|OG001|Outcome|N-Rephasin® SAL200|"To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.~N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304844|NCT03089697|EG000|Reported Event|Placebo|"To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)~Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304845|NCT03089697|EG001|Reported Event|N-Rephasin® SAL200|"To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.~N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA"
11304846|NCT03089879|BG000|Baseline|Shigella Group|Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.
11304847|NCT03089879|BG001|Baseline|Placebo Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304848|NCT03089879|BG002|Baseline|Naïve Group|Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304849|NCT03089879|BG003|Baseline|Total|Total of all reporting groups
11304850|NCT03089879|FG000|Participant Flow|Shigella Group|Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.
11304851|NCT03089879|FG001|Participant Flow|Placebo Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304852|NCT03089879|FG002|Participant Flow|Naïve Group|Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304853|NCT03089879|OG000|Outcome|Shigella Group|Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.
11304854|NCT03089879|OG001|Outcome|Placebo Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304855|NCT03089879|OG002|Outcome|Naïve Group|Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304856|NCT03089879|OG001|Outcome|Placebo + Naïve Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304857|NCT03089879|OG001|Outcome|Placebo + Naive Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304858|NCT03089879|EG000|Reported Event|Shigella Group|Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.
11304859|NCT03089879|EG001|Reported Event|Placebo + Naïve Group|Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
11304860|NCT03089944|BG000|Baseline|Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks|GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
11304861|NCT03089944|FG000|Participant Flow|Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks|GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
11304862|NCT03089944|OG000|Outcome|Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks|GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
11304863|NCT03089944|EG000|Reported Event|Glecaprevir (GLE)/Pibrentasvir (PIB)|GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
11304864|NCT03090100|BG000|Baseline|Guselkumab 100 mg + Placebo|Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
11304865|NCT03090100|BG001|Baseline|Secukinumab 300 mg|Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
11304866|NCT03090100|BG002|Baseline|Total|Total of all reporting groups
11304867|NCT03090100|FG000|Participant Flow|Guselkumab 100 mg + Placebo|Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
11304868|NCT03090100|FG001|Participant Flow|Secukinumab 300 mg|Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
11304869|NCT03090100|OG000|Outcome|Guselkumab 100 mg + Placebo|Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
11304870|NCT03090100|OG001|Outcome|Secukinumab 300 mg|Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
11304871|NCT03090100|EG000|Reported Event|Guselkumab 100 mg + Placebo|Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.
11304872|NCT03090100|EG001|Reported Event|Secukinumab 300 mg|Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
11304873|NCT03090256|BG000|Baseline|TFNT00|AcrySof® IQ PanOptix™ IOL, bilateral implantation
11304874|NCT03090256|FG000|Participant Flow|TFNT00|AcrySof® IQ PanOptix™ IOL, bilateral implantation
11304875|NCT03090256|OG000|Outcome|First Eye|AcrySof® IQ PanOptix™ IOL, first eye implantation
11304876|NCT03090256|OG001|Outcome|Second Eye|AcrySof® IQ PanOptix™ IOL, second eye implantation
11304877|NCT03090256|EG000|Reported Event|TFNT00|All subjects implanted with AcrySof® IQ PanOptix™ IOL
11304878|NCT03090620|BG000|Baseline|Physostigmine|"Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.~Physostigmine: Administration of physostigmine bolus followed by an infusion"
11304879|NCT03090620|BG001|Baseline|Lorazepam|"Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.~Lorazepam: Administration of lorazepam bolus followed by normal saline infusion"
11304880|NCT03090620|BG002|Baseline|Total|Total of all reporting groups
11304881|NCT03090620|FG000|Participant Flow|Physostigmine|"Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.~Physostigmine: Administration of physostigmine bolus followed by an infusion"
11304882|NCT03090620|FG001|Participant Flow|Lorazepam|"Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.~Lorazepam: Administration of lorazepam bolus followed by normal saline infusion"
11304883|NCT03090620|OG000|Outcome|Physostigmine|"Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.~Physostigmine: Administration of physostigmine bolus followed by an infusion"
11304884|NCT03090620|OG001|Outcome|Lorazepam|"Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.~Lorazepam: Administration of lorazepam bolus followed by normal saline infusion"
11304885|NCT03090620|EG000|Reported Event|Physostigmine|"Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.~Physostigmine: Administration of physostigmine bolus followed by an infusion"
11304886|NCT03090620|EG001|Reported Event|Lorazepam|"Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.~Lorazepam: Administration of lorazepam bolus followed by normal saline infusion"
11304887|NCT03090958|BG000|Baseline|AllyQuest Pilot|"The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered.~AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis."
11304888|NCT03090958|FG000|Participant Flow|AllyQuest Pilot|"The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered.~AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis."
11333020|NCT03506425|FG001|Participant Flow|Group 2|"Standard care and Triheptanoin for 6 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333021|NCT03506425|FG002|Participant Flow|Group 3|Healthy controls for biomarkers
11304889|NCT03090958|OG000|Outcome|AllyQuest Pilot|"The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered.~AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis."
11304890|NCT03090958|EG000|Reported Event|AllyQuest Pilot|"The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered.~AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis."
11304891|NCT03091179|BG000|Baseline|THRIVE|THRIVE: active nasal oxygen delivery system
11304892|NCT03091179|BG001|Baseline|Control Group|Endotracheal tube or Supraglottic jet ventilation
11304893|NCT03091179|BG002|Baseline|Total|Total of all reporting groups
11304894|NCT03091179|FG000|Participant Flow|THRIVE|THRIVE: active nasal oxygen delivery system
11304895|NCT03091179|FG001|Participant Flow|Control Group|Endotracheal tube or Supraglottic jet ventilation
11304896|NCT03091179|OG000|Outcome|THRIVE|THRIVE: active nasal oxygen delivery system
11304897|NCT03091179|OG001|Outcome|Control Group|Endotracheal tube or Supraglottic jet ventilation
11304898|NCT03091179|EG000|Reported Event|THRIVE|THRIVE: active nasal oxygen delivery system
11304899|NCT03091179|EG001|Reported Event|Control Group|Endotracheal tube or Supraglottic jet ventilation
11304900|NCT03091348|BG000|Baseline|SQ-IM|"Subcutaneous testosterone injection followed by intramuscular testosterone injection~Testosterone: Testosterone cypionate injection"
11304901|NCT03091348|BG001|Baseline|IM-SQ|"Intramuscular testosterone injection followed by subcutaneous testosterone injection~Testosterone: Testosterone cypionate injection"
11304902|NCT03091348|BG002|Baseline|Total|Total of all reporting groups
11304903|NCT03091348|FG000|Participant Flow|SQ - IM|"Subcutaneous testosterone injection followed by intramuscular testosterone injection~Testosterone: Testosterone cypionate injection"
11304904|NCT03091348|FG001|Participant Flow|IM - SQ|"Intramuscular testosterone injection followed by subcutaneous testosterone injection~Testosterone: Testosterone cypionate injection"
11304905|NCT03091348|OG000|Outcome|"SQ"|Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
11304906|NCT03091348|OG001|Outcome|"IM"|Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
11304907|NCT03091348|OG001|Outcome|"IM"|Intramuscular testosterone injection Testosterone : Testosterone cypionate injection
11304908|NCT03091348|EG000|Reported Event|SQ Testosterone|Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
11304909|NCT03091348|EG001|Reported Event|IM Testosterone|Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
11304910|NCT03091361|BG000|Baseline|All Patients (Imaging/no Intervention)|There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
11304911|NCT03091361|FG000|Participant Flow|All Patients (Imaging/no Intervention)|There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
11304912|NCT03091361|OG000|Outcome|All Patients (Imaging/no Intervention)|There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
11304913|NCT03091361|EG000|Reported Event|All Patients (Imaging/no Intervention)|There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
11304914|NCT03091400|BG000|Baseline|Atomoxetine, Then Placebo|"Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)~then a two-week washout period, then~Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)"
11304915|NCT03091400|BG001|Baseline|Placebo, Then Atomoxetine|"Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)~then a two-week washout period, then~Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)"
11304916|NCT03091400|BG002|Baseline|Total|Total of all reporting groups
11304917|NCT03091400|FG000|Participant Flow|Atomoxetine Then Placebo|"Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)~then a two-week washout period, then~Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)"
11304918|NCT03091400|FG001|Participant Flow|Placebo Then Atomoxetine|"Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)~then a two-week washout period, then~Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)"
11304919|NCT03091400|OG000|Outcome|Atomoxetine|Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
11304920|NCT03091400|OG001|Outcome|Placebo|Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
10971894|NCT00918203|FG001|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971895|NCT00918203|FG002|Participant Flow|Crossover to Olaratumab Monotherapy|Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.
10971896|NCT00918203|OG000|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971897|NCT00918203|OG001|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971898|NCT00918203|OG002|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
10971899|NCT00918203|OG000|Outcome|Olaratumab + Pacilitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
11304921|NCT03091400|EG000|Reported Event|Atomoxetine|Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
11304922|NCT03091400|EG001|Reported Event|Placebo|Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
11304923|NCT03091439|BG000|Baseline|Dalbavancin|Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
11304924|NCT03091439|BG001|Baseline|Standard of Care|Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
11304925|NCT03091439|BG002|Baseline|Total|Total of all reporting groups
11304926|NCT03091439|FG000|Participant Flow|Dalbavancin|Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
11304927|NCT03091439|FG001|Participant Flow|Standard of Care|Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
11304928|NCT03091439|OG000|Outcome|Dalbavancin|Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
11304929|NCT03091439|OG001|Outcome|Standard of Care|Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
11304930|NCT03091439|EG000|Reported Event|Dalbavancin|Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
11304931|NCT03091439|EG001|Reported Event|Standard of Care|Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
11304932|NCT03091478|BG000|Baseline|Pembrolizumab 200 mg|Pembrolizumab 200 mg every 3 weeks
11304933|NCT03091478|FG000|Participant Flow|Pembrolizumab 200 mg|Pembrolizumab 200 mg every 3 weeks
11304934|NCT03091478|OG000|Outcome|Pembrolizumab 200 mg|Pembrolizumab 200 mg every 3 weeks
11304935|NCT03091478|EG000|Reported Event|Pembrolizumab 200 mg|"Pembrolizumab 200 mg every 3 weeks~Pembrolizumab: 200mg every 3 weeks"
11304936|NCT03091673|BG000|Baseline|Subjects 2 to <6 Years of Age|Study subjects at least 2, but less than 6 years of age at the time of dosing
11304937|NCT03091673|BG001|Baseline|Subjects 6 to <12 Years of Age|Study subjects at least 6, but less than 12 years of age at the time of dosing
11304938|NCT03091673|BG002|Baseline|Subjects 12 to <18 Years of Age|Study subjects at least 12, but less than 18 years of age at the time of dosing
11304939|NCT03091673|BG003|Baseline|Total|Total of all reporting groups
11304940|NCT03091673|FG000|Participant Flow|G-Pen (Glucagon Injection) 0.5 mg|"A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)~Glucagon: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector"
11304941|NCT03091673|FG001|Participant Flow|G-Pen (Glucagon Injection) 1.0 mg|"A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)~Glucagon: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector"
11304942|NCT03091673|OG000|Outcome|Subjects 2 to <6 Years of Age|Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
11304943|NCT03091673|OG001|Outcome|Subjects 6 to <12 Years of Age|Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
11304944|NCT03091673|OG002|Outcome|Subjects 12 to <18 Years of Age|Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
11304945|NCT03091673|OG000|Outcome|Subjects 2 to <6 Years of Age|Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen
11304946|NCT03091673|OG001|Outcome|Subjects 6 to <12 Years of Age|Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen
11304947|NCT03091673|OG002|Outcome|Subjects 12 to <18 Years of Age|Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen
11304948|NCT03091673|EG000|Reported Event|Subjects 2 to <6 Years of Age|Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
11304949|NCT03091673|EG001|Reported Event|Subjects 6 to <12 Years of Age|Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
11304950|NCT03091673|EG002|Reported Event|Subjects 12 to <18 Years of Age|Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
11304951|NCT03091738|BG000|Baseline|Ramelteon Pill|"Patients given ramelteon and re-evaluated after 15 days of therapy~Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon"
11304952|NCT03091738|FG000|Participant Flow|Ramelteon Pill|"Patients given ramelteon and re-evaluated after 15 days of therapy~Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon"
11304953|NCT03091738|OG000|Outcome|Ramelteon Pill|"Patients given ramelteon and re-evaluated after 15 days of therapy~Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon"
11304954|NCT03091738|EG000|Reported Event|Ramelteon Pill|"Patients given ramelteon and re-evaluated after 15 days of therapy~Ramelteon Pill: Patients with compensated cirrhosis and insomnia will be provided ramelteon"
11304955|NCT03091751|BG000|Baseline|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
11304956|NCT03091751|FG000|Participant Flow|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
11304957|NCT03091751|OG000|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
11304958|NCT03091751|EG000|Reported Event|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.~BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
11304959|NCT03091777|BG000|Baseline|Test Drug|"GDC-229 gel applied vaginally as directed.~GDC-229: GDC-229 is a vaginal gel."
11304960|NCT03091777|BG001|Baseline|Reference Drug|"Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.~Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug"
11304961|NCT03091777|BG002|Baseline|Vehicle Placebo Gel|"GDC-229 Vehicle~Placebo: Inactive arm of the study"
11304962|NCT03091777|BG003|Baseline|Total|Total of all reporting groups
11304963|NCT03091777|FG000|Participant Flow|Test Drug|"GDC-229 gel applied vaginally as directed.~GDC-229: GDC-229 is a vaginal gel."
11304964|NCT03091777|FG001|Participant Flow|Reference Drug|"Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.~Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug"
11304965|NCT03091777|FG002|Participant Flow|Vehicle Placebo Gel|"GDC-229 Vehicle~Placebo: Inactive arm of the study"
11304966|NCT03091777|OG000|Outcome|Test Drug|"GDC-229 gel applied vaginally as directed.~GDC-229: GDC-229 is a vaginal gel."
11304967|NCT03091777|OG001|Outcome|Reference Drug|"Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.~Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug"
11304968|NCT03091777|OG002|Outcome|Vehicle Placebo Gel|"GDC-229 Vehicle~Placebo: Inactive arm of the study"
11304969|NCT03091777|EG000|Reported Event|Test Drug|"GDC-229 gel applied vaginally as directed.~GDC-229: GDC-229 is a vaginal gel."
11304970|NCT03091777|EG001|Reported Event|Reference Drug|"Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.~Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug"
11304971|NCT03091777|EG002|Reported Event|Vehicle Placebo Gel|"GDC-229 Vehicle~Placebo: Inactive arm of the study"
11304972|NCT03091920|BG000|Baseline|Placebo|Placebo oral tablet taken in AM and in PM on Days 1-14.
11304973|NCT03091920|BG001|Baseline|IW-1973 40 mg BID/QD|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
11304974|NCT03091920|BG002|Baseline|IW-1973 40 mg QD/QD|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304975|NCT03091920|BG003|Baseline|Total|Total of all reporting groups
11304976|NCT03091920|FG000|Participant Flow|Placebo|Placebo oral tablet taken morning (AM) and night (PM) on Days 1-14.
11304977|NCT03091920|FG001|Participant Flow|IW-1973 40 mg Twice Dily (BID)/Once Daily (QD)|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
11304978|NCT03091920|FG002|Participant Flow|IW-1973 40 mg QD/QD|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304979|NCT03091920|OG000|Outcome|Placebo|Placebo oral tablet taken in AM and in PM on Days 1-14.
11304980|NCT03091920|OG001|Outcome|IW-1973 40 mg BID/QD|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
11304981|NCT03091920|OG002|Outcome|IW-1973 40 mg QD/QD|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304982|NCT03091920|OG003|Outcome|IW-1973 40 mg Total Daily Dose (Overall)|"IW-1973 40 mg BID/QD:~IW-973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7. IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14.~IW-1973 40 mg QD/QD:~IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14."
11304983|NCT03091920|OG000|Outcome|IW-1973 40 mg BID/QD: 20 mg AM|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
11304984|NCT03091920|OG001|Outcome|IW-1973 40 mg BID/QD: 20 mg PM|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
10971900|NCT00918203|OG000|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971901|NCT00918203|OG001|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
10971902|NCT00918203|OG000|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
11304985|NCT03091920|OG002|Outcome|IW-1973 40 mg QD/QD: 40 mg AM|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304986|NCT03091920|OG000|Outcome|IW-1973 40 mg BID/QD: 40 mg AM|IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14.
11304987|NCT03091920|OG001|Outcome|IW-1973 40 mg QD/QD: 40 mg AM|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304988|NCT03091920|EG000|Reported Event|Placebo|Placebo oral tablet taken in AM and in PM on Days 1-14.
11304989|NCT03091920|EG001|Reported Event|IW-1973 40 mg BID/QD|"IW-1973 20 mg oral tablet taken in AM and 20 mg oral tablet taken in PM on Days 1-7.~IW-1973 40 mg oral tablet taken QD in AM and placebo oral tablet taken QD in PM on Days 8-14."
11304990|NCT03091920|EG002|Reported Event|IW-1973 40 mg QD/QD|IW-1973 40 mg oral tablet taken QD in AM and placebo taken QD in PM on Days 1-14.
11304991|NCT03092024|BG000|Baseline|SPIN-HAND Program|SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
11304992|NCT03092024|BG001|Baseline|Not Offered the SPIN-HAND Program|Treatment as usual
11304993|NCT03092024|BG002|Baseline|Total|Total of all reporting groups
11304994|NCT03092024|FG000|Participant Flow|SPIN-HAND Program|SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
11304995|NCT03092024|FG001|Participant Flow|Not Offered the SPIN-HAND Program|Treatment as usual
11304996|NCT03092024|OG000|Outcome|SPIN-HAND Program|SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
11304997|NCT03092024|OG001|Outcome|Not Offered the SPIN-HAND Program|Treatment as usual
11304998|NCT03092024|EG000|Reported Event|SPIN-HAND Program|SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
11304999|NCT03092024|EG001|Reported Event|Not Offered the SPIN-HAND Program|Treatment as usual
11305000|NCT03092089|BG000|Baseline|Adult Patients With High Risk STEMI|"Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI)~Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI~Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up~Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care"
11305001|NCT03092089|FG000|Participant Flow|Adult Patients With High Risk STEMI|"Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI)~Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI~Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up~Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care"
11305002|NCT03092089|OG000|Outcome|Adult Patients With High Risk STEMI|"Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI)~Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI~Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up~Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care"
11305003|NCT03092089|EG000|Reported Event|Adult Patients With High Risk STEMI|"Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI)~Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI~Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up~Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care"
11305004|NCT03092375|BG000|Baseline|Arm A: G/P 300 mg/120 mg QD for 12 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305005|NCT03092375|BG001|Baseline|Arm B: G/P 300 mg/120 mg QD for 16 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305006|NCT03092375|BG002|Baseline|Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily~Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg"
11305007|NCT03092375|BG003|Baseline|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305008|NCT03092375|BG004|Baseline|Total|Total of all reporting groups
11305009|NCT03092375|FG000|Participant Flow|Arm A: G/P 300 mg/120 mg QD for 12 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305010|NCT03092375|FG001|Participant Flow|Arm B: G/P 300 mg/120 mg QD for 16 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305011|NCT03092375|FG002|Participant Flow|Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily~Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg"
11305012|NCT03092375|FG003|Participant Flow|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305013|NCT03092375|OG000|Outcome|Arm A: G/P 300 mg/120 mg QD for 12 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305014|NCT03092375|OG001|Outcome|Arm B: G/P 300 mg/120 mg QD for 16 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305015|NCT03092375|OG000|Outcome|Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily~Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg"
11305016|NCT03092375|OG001|Outcome|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Arm D includes Cirrhotic subjects receiving Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305017|NCT03092375|OG002|Outcome|Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily~Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg"
11305018|NCT03092375|OG003|Outcome|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305019|NCT03092375|OG000|Outcome|Arms A G/P 300 mg/120 mg QD for 12 Weeks|Arms A includes non-cirrhotic subjects receiving Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth with or without Ribavirin for 12 weeks (Arm A) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily
11305020|NCT03092375|OG001|Outcome|Arm B G/P 300/120mg Once Daily for 16 Weeks|"Arm B includes non-cirrhotic subjects receiving Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305021|NCT03092375|OG000|Outcome|Arm A: G/P 300 mg/120 mg QD for 12 Wks|"Non-cirrhotic subjects receiving Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305022|NCT03092375|OG001|Outcome|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects receiving Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305023|NCT03092375|OG001|Outcome|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305024|NCT03092375|EG000|Reported Event|Arm A: G/P 300 mg/120 mg QD for 12 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305025|NCT03092375|EG001|Reported Event|Arm B: G/P 300 mg/120 mg QD for 16 Wks|"Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305026|NCT03092375|EG002|Reported Event|Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily~Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg"
11305027|NCT03092375|EG003|Reported Event|Arm D: G/P 300 mg/120 mg QD for 16 Wks|"Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)~Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily"
11305028|NCT03092479|BG000|Baseline|Behavioral Intervention|"4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.~Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain."
11305029|NCT03092479|BG001|Baseline|Usual Care|Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
11305030|NCT03092479|BG002|Baseline|Total|Total of all reporting groups
11305031|NCT03092479|FG000|Participant Flow|Behavioral Intervention|"4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.~Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain."
11305032|NCT03092479|FG001|Participant Flow|Usual Care|Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
11305033|NCT03092479|OG000|Outcome|Behavioral Intervention|"4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.~Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain."
11305034|NCT03092479|OG001|Outcome|Usual Care|Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
11305035|NCT03092479|EG000|Reported Event|Behavioral Intervention|"4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.~Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain."
11305036|NCT03092479|EG001|Reported Event|Usual Care|Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
11305037|NCT03092726|BG000|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11305038|NCT03092726|BG001|Baseline|ASP8062|Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
11305039|NCT03092726|BG002|Baseline|Total|Total of all reporting groups
11305040|NCT03092726|FG000|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11305041|NCT03092726|FG001|Participant Flow|ASP8062|Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
11305042|NCT03092726|OG000|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11305043|NCT03092726|OG001|Outcome|ASP8062|Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
11305044|NCT03092726|EG000|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
11305045|NCT03092726|EG001|Reported Event|ASP8062 30 mg|Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
11305046|NCT03092752|BG000|Baseline|Oral Antibiotic Drugs|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidyl-peptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α-glucosidase and glinides as per prescription in Japan.
11305047|NCT03092752|FG000|Participant Flow|Oral Antibiotic Drugs|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidyl-peptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α-glucosidase and glinides as per prescription in Japan.
11305048|NCT03092752|OG000|Outcome|Group G1|The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
11305049|NCT03092752|OG001|Outcome|Group G2|The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
11305050|NCT03092752|OG002|Outcome|Group G3|The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
11305051|NCT03092752|OG003|Outcome|Group G4+|The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
11305052|NCT03092752|OG004|Outcome|Total|Total for all participants
11305053|NCT03092752|OG000|Outcome|Oral Antibiotic Drugs|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidylpeptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α- glucosidase and glinides as per prescription in Japan.
11305054|NCT03092752|OG000|Outcome|Dipeptidyl-peptidase 4 Inhibitor (DPP4i)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Dipeptidyl-peptidase 4 inhibitors (DPP4i), as per prescription in Japan.
11305055|NCT03092752|OG001|Outcome|Biguanides (BG)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Biguanide (BG), as per prescription in Japan.
11305056|NCT03092752|OG002|Outcome|Sulfonylurea (SU)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Sulfonylureas (SU), as per prescription in Japan.
11305057|NCT03092752|OG003|Outcome|α-glucosidase (AGI)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), α-glucosidase (AGI), as per prescription in Japan.
11305058|NCT03092752|OG004|Outcome|Glinide|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Glinide, as per prescription in Japan.
11305059|NCT03092752|OG005|Outcome|Thiazolidinedione (TZD)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
11305060|NCT03092752|OG006|Outcome|Total|Total for all participants
11305061|NCT03092752|EG000|Reported Event|Dipeptidyl-peptidase 4 Inhibitor (DPP4i)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Dipeptidyl-peptidase 4 inhibitors (DPP4i), as per prescription in Japan.
11305062|NCT03092752|EG001|Reported Event|Biguanides (BG)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Biguanide (BG), as per prescription in Japan.
11305063|NCT03092752|EG002|Reported Event|Sulfonylurea (SU)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Sulfonylureas (SU), as per prescription in Japan.
11305064|NCT03092752|EG003|Reported Event|α-glucosidase (AGI)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), α-glucosidase (AGI), as per prescription in Japan.
11305065|NCT03092752|EG004|Reported Event|Glinide|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Glinide, as per prescription in Japan.
11305066|NCT03092752|EG005|Reported Event|Thiazolidinedione (TZD)|Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
11305067|NCT03092791|BG000|Baseline|Adult Lead-in Cohort: sIPV High Dose|Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305068|NCT03092791|BG001|Baseline|Adult Lead-in Cohort: Placebo|Placebo, intramuscular injection on Day 1.
11305069|NCT03092791|BG002|Baseline|Toddler Lead-in Cohort: sIPV High Dose|sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305070|NCT03092791|BG003|Baseline|Toddler Lead-in Cohort: Reference IPV|Reference IPV, intramuscular injection on Day 1.
11305071|NCT03092791|BG004|Baseline|Infant Dose Ranging Cohort: sIPV Low Dose|sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305072|NCT03092791|BG005|Baseline|Infant Dose Ranging Cohort: sIPV Medium Dose|sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305073|NCT03092791|BG006|Baseline|Infant Dose Ranging Cohort: sIPV High Dose|sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305074|NCT03092791|BG007|Baseline|Infant Dose Ranging Cohort: Reference IPV|Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
11305075|NCT03092791|BG008|Baseline|Total|Total of all reporting groups
11305076|NCT03092791|FG000|Participant Flow|Adult Lead-in Cohort: sIPV High Dose|Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305077|NCT03092791|FG001|Participant Flow|Adult Lead-in Cohort: Placebo|Placebo, intramuscular injection on Day 1.
11305078|NCT03092791|FG002|Participant Flow|Toddler Lead-in Cohort: sIPV High Dose|sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305079|NCT03092791|FG003|Participant Flow|Toddler Lead-in Cohort: Reference IPV|Reference IPV, intramuscular injection on Day 1.
11305080|NCT03092791|FG004|Participant Flow|Infant Dose Ranging Cohort: sIPV Low Dose|sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305081|NCT03092791|FG005|Participant Flow|Infant Dose Ranging Cohort: sIPV Medium Dose|sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305082|NCT03092791|FG006|Participant Flow|Infant Dose Ranging Cohort: sIPV High Dose|sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305083|NCT03092791|FG007|Participant Flow|Infant Dose Ranging Cohort: Reference IPV|Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
11305084|NCT03092791|OG000|Outcome|Infant Dose Ranging Cohort: sIPV Low Dose|sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305085|NCT03092791|OG001|Outcome|Infant Dose Ranging Cohort: sIPV Medium Dose|sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305086|NCT03092791|OG002|Outcome|Infant Dose Ranging Cohort: sIPV High Dose|sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305087|NCT03092791|OG003|Outcome|Infant Dose Ranging Cohort: Reference IPV|Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
11305088|NCT03092791|OG000|Outcome|Toddler Lead-in Cohort: sIPV High Dose|sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305089|NCT03092791|OG001|Outcome|Toddler Lead-in Cohort: Reference IPV|Reference IPV, intramuscular injection on Day 1.
11305090|NCT03092791|OG000|Outcome|Adult Lead-in Cohort: sIPV High Dose|Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305091|NCT03092791|OG001|Outcome|Adult Lead-in Cohort: Placebo|Placebo, intramuscular injection on Day 1.
11305092|NCT03092791|EG000|Reported Event|Adult Lead-in Cohort: sIPV High Dose|Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305093|NCT03092791|EG001|Reported Event|Adult Lead-in Cohort: Placebo|Placebo, intramuscular injection on Day 1.
11305094|NCT03092791|EG002|Reported Event|Toddler Lead-in Cohort: sIPV High Dose|sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
11305095|NCT03092791|EG003|Reported Event|Toddler Lead-in Cohort: Reference IPV|Reference IPV, intramuscular injection on Day 1.
11305096|NCT03092791|EG004|Reported Event|Infant Dose Ranging Cohort: sIPV Low Dose|sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305097|NCT03092791|EG005|Reported Event|Infant Dose Ranging Cohort: sIPV Medium Dose|sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305098|NCT03092791|EG006|Reported Event|Infant Dose Ranging Cohort: sIPV High Dose|sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
11305099|NCT03092791|EG007|Reported Event|Infant Dose Ranging Cohort: Reference IPV|Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
11305100|NCT03092934|BG000|Baseline|25 Milligrams (mg) LY3295668 (Phase 1)|25 mg LY3295668 twice daily (BID) administered orally in 21-day cycles.
11305101|NCT03092934|BG001|Baseline|50 mg LY3295668 (Phase 1)|"50 milligrams (mg) LY3295668 BID administered orally in 21-day cycles.~LY3295668: Oral capsules"
11305102|NCT03092934|BG002|Baseline|75 mg LY3295668 (Phase 1)|"75 mg LY3295668 BID administered orally in 21-day cycles.~LY3295668: Oral capsules"
11305103|NCT03092934|BG003|Baseline|25 mg LY3295668 (Phase 2)|"25 mg LY3295668 BID administered orally in 21-day cycles.~LY3295668: Oral capsules"
11305104|NCT03092934|BG004|Baseline|Total|Total of all reporting groups
11305105|NCT03092934|FG000|Participant Flow|25 Milligrams (mg) LY3295668 (Phase 1)|25 mg LY3295668 twice daily (BID) administered orally in 21-day cycles.
11305106|NCT03092934|FG001|Participant Flow|50 mg LY3295668 (Phase 1)|50 mg LY3295668 BID administered orally in 21-day cycles.
11305107|NCT03092934|FG002|Participant Flow|75 mg LY3295668 (Phase 1)|75 mg LY3295668 BID administered orally in 21-day cycles.
11305108|NCT03092934|FG003|Participant Flow|25 mg LY3295668 (Phase 2)|25 mg LY3295668 BID administered orally in 21-day cycles.
11305109|NCT03092934|OG000|Outcome|LY3295668 Phase 1|25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles.
11305110|NCT03092934|OG000|Outcome|25 mg LY3295668 (Phase 2)|25 mg LY3295668 BID administered orally in 21-day cycles.
11305111|NCT03092934|OG000|Outcome|25 mg LY3295668 (Phase 1)|25 mg LY3295668 BID administered orally in 21-day cycles.
11305112|NCT03092934|OG001|Outcome|50 mg LY3295668 (Phase 1)|50 mg LY3295668 BID administered orally in 21-day cycles.
11305113|NCT03092934|OG002|Outcome|75 mg LY3295668 (Phase 1)|75 mg LY3295668 BID administered orally in 21-day cycles.
11305114|NCT03092934|EG000|Reported Event|25 Milligrams (mg) LY3295668|25 mg LY3295668 BID administered orally in 21-day cycles. Phase 1 and Phase 2 participants have been combined.
11305115|NCT03092934|EG001|Reported Event|50 mg LY3295688|50 mg LY3295668 BID administered orally in 21-day cycles.
11305116|NCT03092934|EG002|Reported Event|75 mg LY3295688|75 mg LY3295668 BID administered orally in 21-day cycles
11305117|NCT03092960|BG000|Baseline|Minimal Intensity Intervention|"Patients assigned to this group will received the Minimal intensity intervention.~Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant."
11305118|NCT03092960|BG001|Baseline|HOMBRE|"Patients assigned to this group will receive the HOMBRE intervention~HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach."
11305119|NCT03092960|BG002|Baseline|Total|Total of all reporting groups
11305120|NCT03092960|FG000|Participant Flow|Minimal Intensity Intervention|"Patients assigned to this group will received the Minimal intensity intervention.~Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant."
11305121|NCT03092960|FG001|Participant Flow|HOMBRE|"Patients assigned to this group will receive the HOMBRE intervention~HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach."
11305122|NCT03092960|OG000|Outcome|Minimal Intensity Intervention|"Patients assigned to this group will received the Minimal intensity intervention.~Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant."
11305123|NCT03092960|OG001|Outcome|HOMBRE|"Patients assigned to this group will receive the HOMBRE intervention~HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach."
11305124|NCT03092960|EG000|Reported Event|Minimal Intensity Intervention|"Patients assigned to this group will received the Minimal intensity intervention.~Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant."
11305125|NCT03092960|EG001|Reported Event|HOMBRE|"Patients assigned to this group will receive the HOMBRE intervention~HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach."
11305126|NCT03093025|BG000|Baseline|TS-121 10mg|TS-121 10 mg: Orally taken once daily
11305127|NCT03093025|BG001|Baseline|TS-121 50mg|TS-121 50 mg: Orally taken once daily
11305128|NCT03093025|BG002|Baseline|Placebo|Placebo: Orally taken once daily
11305129|NCT03093025|BG003|Baseline|Total|Total of all reporting groups
11305130|NCT03093025|FG000|Participant Flow|TS-121 10mg|TS-121 10 mg: Orally taken once daily
11305131|NCT03093025|FG001|Participant Flow|TS-121 50mg|TS-121 50 mg: Orally taken once daily
11305132|NCT03093025|FG002|Participant Flow|Placebo|Placebo: Orally taken once daily
11305133|NCT03093025|OG000|Outcome|TS-121 10mg|TS-121 10 mg: Orally taken once daily
11305134|NCT03093025|OG001|Outcome|TS-121 50mg|TS-121 50 mg: Orally taken once daily
11305135|NCT03093025|OG002|Outcome|Placebo|Placebo: Orally taken once daily
11305136|NCT03093025|EG000|Reported Event|TS-121 10mg|TS-121 10 mg: Orally taken once daily
11305137|NCT03093025|EG001|Reported Event|TS-121 50mg|TS-121 50 mg: Orally taken once daily
11305138|NCT03093025|EG002|Reported Event|Placebo|Placebo: Orally taken once daily
11305139|NCT03093181|BG000|Baseline|Test Product Regimen|Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing.
11305140|NCT03093181|BG001|Baseline|No Treatment Regimen|Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours.
11305141|NCT03093181|BG002|Baseline|Positive Control Regimen|Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing.
11305142|NCT03093181|BG003|Baseline|Total|Total of all reporting groups
11305143|NCT03093181|FG000|Participant Flow|Test Product Regimen|Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing.
11305144|NCT03093181|FG001|Participant Flow|No Treatment Regimen|Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours.
11305145|NCT03093181|FG002|Participant Flow|Positive Control Regimen|Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing.
11305146|NCT03093181|OG000|Outcome|Test Product Regimen|Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing.
11305147|NCT03093181|OG001|Outcome|No Treatment Regimen|Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours.
11305148|NCT03093181|OG002|Outcome|Positive Control Regimen|Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing.
11305149|NCT03093181|EG000|Reported Event|Test Product Regimen|Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing.
11305150|NCT03093181|EG001|Reported Event|No Treatment Regimen|Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours.
11305151|NCT03093181|EG002|Reported Event|Positive Control Regimen|Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing.
11305152|NCT03093207|BG000|Baseline|Control Group|"In this group (n = 17), patients will take placebo pills and open flap debridement will be performed to treat residual pockets.~Open flap debridement: Open flap debridement will be performed to decontaminate root surface~Placebo: Placebo pills over a period of 180 days"
11305153|NCT03093207|BG001|Baseline|Test Group|"In this group (n = 17), patients will take 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement will be performed to treat residual pockets.~Open flap debridement: Open flap debridement will be performed to decontaminate root surface~Omega-3 polyunsaturated fatty acids: 3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days~Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days"
11305154|NCT03093207|BG002|Baseline|Total|Total of all reporting groups
11305155|NCT03093207|FG000|Participant Flow|Control Group|"In this group (n = 17), patients received placebo pills and open flap debridement to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface~Placebo: Placebo pills over a period of 180 days"
11305156|NCT03093207|FG001|Participant Flow|Test Group|"In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface~Omega-3 polyunsaturated fatty acids: 3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days~Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days"
11305157|NCT03093207|OG000|Outcome|Test Group|"In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface~Omega-3 polyunsaturated fatty acids: 3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days~Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days"
11305158|NCT03093207|OG001|Outcome|Control Group|"In this group (n = 17), patients received placebo pills over a period of 180 days and open flap debridement was performed to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface"
11305159|NCT03093207|EG000|Reported Event|Control Group|"In this group (n = 17), patients received placebo pills and open flap debridement to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface~Placebo: Placebo pills over a period of 180 days"
11305160|NCT03093207|EG001|Reported Event|Test Group|"In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.~Open flap debridement: Open flap debridement was performed to decontaminate root surface~Omega-3 polyunsaturated fatty acids: 3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days~Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days"
11305161|NCT03093272|BG000|Baseline|Apalutamide Combined With Docetaxel|"Apalutamide (ARN-509): 240mg (four 60mg tablets), oral, once daily~Docetaxel: 75mg/m2 in 250cc Normal Saline, IV, every 21 days (3 weeks)~Prednisone: 5mg, oral, twice daily"
11305162|NCT03093272|FG000|Participant Flow|Apalutamide Combined With Docetaxel|"Apalutamide (ARN-509): 240mg (four 60mg tablets), oral, once daily~Docetaxel: 75mg/m2 in 250cc Normal Saline, IV, every 21 days (3 weeks)~Prednisone: 5mg, oral, twice daily"
11305163|NCT03093272|OG000|Outcome|Apalutamide Combined With Docetaxel|"Apalutamide (ARN-509): 240mg (four 60mg tablets), oral, once daily~Docetaxel: 75mg/m2 in 250cc Normal Saline, IV, every 21 days (3 weeks)~Prednisone: 5mg, oral, twice daily"
11305164|NCT03093272|EG000|Reported Event|Apalutamide Combined With Docetaxel|"Apalutamide (ARN-509): 240mg (four 60mg tablets), oral, once daily~Docetaxel: 75mg/m2 in 250cc Normal Saline, IV, every 21 days (3 weeks)~Prednisone: 5mg, oral, twice daily"
11305165|NCT03093324|BG000|Baseline|ALKS 8700|Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
11305166|NCT03093324|BG001|Baseline|Dimethyl Fumarate (DMF)|Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
11305167|NCT03093324|BG002|Baseline|Total|Total of all reporting groups
11305168|NCT03093324|FG000|Participant Flow|ALKS 8700|Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
11305169|NCT03093324|FG001|Participant Flow|Dimethyl Fumarate (DMF)|Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
11305170|NCT03093324|OG000|Outcome|ALKS 8700|Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
11305171|NCT03093324|OG001|Outcome|Dimethyl Fumarate (DMF)|Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
11305172|NCT03093324|EG000|Reported Event|ALKS 8700|Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
11305173|NCT03093324|EG001|Reported Event|Dimethyl Fumarate (DMF)|Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
11305174|NCT03093415|BG000|Baseline|Old Town Clinic, Medication Assisted Therapy Group|"25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305175|NCT03093415|BG001|Baseline|Outside In Clinic, Needle Exchange Program|"25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305176|NCT03093415|BG002|Baseline|OHSU Hepatology Clinic, Academic Center Retrospective Cohort|"50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health & Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305177|NCT03093415|BG003|Baseline|Total|Total of all reporting groups
11305178|NCT03093415|FG000|Participant Flow|Old Town Clinic, Medication Assisted Therapy Group|"25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305179|NCT03093415|FG001|Participant Flow|Outside In Clinic, Needle Exchange Program|"25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305180|NCT03093415|FG002|Participant Flow|OHSU Hepatology Clinic, Academic Center Retrospective Cohort|"50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health & Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305181|NCT03093415|OG000|Outcome|Old Town Clinic, Medication Assisted Therapy Group|"25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305182|NCT03093415|OG001|Outcome|Outside In Clinic, Needle Exchange Program|"25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305183|NCT03093415|OG002|Outcome|OHSU Hepatology Clinic, Academic Center Retrospective Cohort|"50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health & Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305184|NCT03093415|EG000|Reported Event|Old Town Clinic, Medication Assisted Therapy Group|"25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305185|NCT03093415|EG001|Reported Event|Outside In Clinic, Needle Exchange Program|"25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305186|NCT03093415|EG002|Reported Event|OHSU Hepatology Clinic, Academic Center Retrospective Cohort|"50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health & Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.~elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)"
11305187|NCT03093454|BG000|Baseline|Placebo/Control|"Patient will receive coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Coconut Essential Oil: Coconut essential oil will be applied topically and by inhalation to the control group."
11305188|NCT03093454|BG001|Baseline|Lavender Group|"Patient will receive lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Lavender Essential Oil: Lavender essential oil will be applied topically and by inhalation to the lavender group."
11305189|NCT03093454|BG002|Baseline|Total|Total of all reporting groups
11305190|NCT03093454|FG000|Participant Flow|Control Group|"Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Coconut Essential Oil: will be applied topically and by inhalation to the control group.~Completed daily surveys during inpatient stay in the hospital."
11305191|NCT03093454|FG001|Participant Flow|Lavender Group|"Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.~Completed daily surveys during inpatient stay in the hospital."
11305192|NCT03093454|OG000|Outcome|Control Group|"Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Coconut Essential Oil: will be applied topically and by inhalation to the control group.~Completed daily surveys during inpatient stay in the hospital."
11305193|NCT03093454|OG001|Outcome|Lavender Group|"Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.~Completed daily surveys during inpatient stay in the hospital."
11305194|NCT03093454|EG000|Reported Event|Control|"Patient will receive coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Coconut Essential Oil: Coconut essential oil will be applied topically and by inhalation to the control group."
11305195|NCT03093454|EG001|Reported Event|Lavender Group|"Patient will receive lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.~Lavender Essential Oil: Lavender essential oil will be applied topically and by inhalation to the lavender group."
11305196|NCT03093662|BG000|Baseline|Ventilation With Nasal Cannula First|"Non-invasive positive pressure ventilation with nasal cannula first followed by non-invasive positive pressure ventilation without nasal cannula.~Ventilation with nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).~Ventilation without nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E)."
11305197|NCT03093662|BG001|Baseline|Ventilation Without Nasal Cannula First|"Non-invasive positive pressure ventilation without nasal cannula first followed by non-invasive positive pressure ventilation with nasal cannula.~Ventilation with nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).~Ventilation without nasal cannula: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E)."
11305198|NCT03093662|BG002|Baseline|Total|Total of all reporting groups
11305199|NCT03093662|FG000|Participant Flow|Ventilation With Nasal Cannula First, Then Without Nasal Cannula|"First intervention: subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).~Second intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E)."
11305200|NCT03093662|FG001|Participant Flow|Ventilation Without Nasal Cannula First, Then With Nasal Cannula|"First intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).~Second intervention: Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E)."
11305201|NCT03093662|OG000|Outcome|Ventilation With Nasal Cannula|Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
11305202|NCT03093662|OG001|Outcome|Ventilation Without Nasal Cannula|Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
11305203|NCT03093662|EG000|Reported Event|Ventilation With Nasal Cannula|"Subject is fitted with a face mask and undergoes 3 continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and exhales into an oxygen sensor (Maxtec Max-250E).~The cross over design means all patients eventually underwent both ventilation with nasal cannula and ventilation without nasal cannula, accounting for any combining of patients in analysis."
11305204|NCT03093662|EG001|Reported Event|Ventilation Without Nasal Cannula|"Subject is fitted with a face mask and undergoes 3 continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and exhales into an oxygen sensor (Maxtec Max-250E).~The cross over design means all patients eventually underwent both ventilation with nasal cannula and ventilation without nasal cannula, accounting for any combining of patients in analysis."
11305205|NCT03093870|BG000|Baseline|Varlitinib and Capecitabine - Safety Lead-In|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305206|NCT03093870|BG001|Baseline|Varlitinib and Capecitabine - Part 1|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305207|NCT03093870|BG002|Baseline|Placebo and Capecitabine - Part 1|"Placebo (for Varlitinib): oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305208|NCT03093870|BG003|Baseline|Total|Total of all reporting groups
11305209|NCT03093870|FG000|Participant Flow|Varlitinib and Capecitabine - Safety Lead-In|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305210|NCT03093870|FG001|Participant Flow|Varlitinib and Capecitabine - Part 1|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305211|NCT03093870|FG002|Participant Flow|Placebo and Capecitabine - Part 1|"Placebo (for Varlitinib): oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305212|NCT03093870|OG000|Outcome|Varlitinib and Capecitabine|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305213|NCT03093870|OG001|Outcome|Placebo and Capecitabine|"Placebo (for Varlitinib): oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305214|NCT03093870|OG000|Outcome|Varlitinib + Capecitabine|This part of the study was a single arm, open-label design to assess the safety of varlitinib (300 mg administered BID every day) plus capecitabine (1000 mg/m2 administered BID every day for 14 days, followed by a 7-day rest period) in a small set of subjects (12 to 20 subjects) with 12 subjects completing the PK and ECG evaluations. Treatment was continued until disease progression, development of unacceptable toxicity, withdrawal of consent, or death.
11305215|NCT03093870|EG000|Reported Event|Varlitinib and Capecitabine - Safety Lead-In|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305216|NCT03093870|EG001|Reported Event|Varlitinib and Capecitabine - Part 1|"Varlitinib: Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305217|NCT03093870|EG002|Reported Event|Placebo and Capecitabine - Part 1|"Placebo (for Varlitinib): oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.~Capecitabine: 1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death."
11305218|NCT03094195|BG000|Baseline|EMA401 25mg BID DB|Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
11305219|NCT03094195|BG001|Baseline|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11305220|NCT03094195|BG002|Baseline|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11305221|NCT03094195|BG003|Baseline|Total|Total of all reporting groups
11305222|NCT03094195|FG000|Participant Flow|EMA401 25mg BID DB|Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
11305223|NCT03094195|FG001|Participant Flow|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11305224|NCT03094195|FG002|Participant Flow|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11305225|NCT03094195|FG003|Participant Flow|EMA401 25mg BID -> EMA401 25mg BID TW|Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
11305226|NCT03094195|FG004|Participant Flow|EMA401 25mg BID -> Placebo BID TW|Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
11305227|NCT03094195|FG005|Participant Flow|EMA401 100mg BID -> EMA401 100mg BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
11305228|NCT03094195|FG006|Participant Flow|EMA401 100mg BID -> Placebo BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
11305229|NCT03094195|FG007|Participant Flow|Placebo BID -> Placebo BID TW|Participants on placebo remained on placebo at end of treatment period (week 12)
11305230|NCT03094195|OG000|Outcome|EMA401 25mg BID DB|Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
11305231|NCT03094195|OG001|Outcome|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11305232|NCT03094195|OG002|Outcome|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11305233|NCT03094195|OG000|Outcome|EMA401 25mg BID -> EMA401 25mg BID|Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
11305234|NCT03094195|OG001|Outcome|EMA401 25mg BID -> Placebo BID|Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
11305235|NCT03094195|OG002|Outcome|EMA401 100mg BID -> EMA401 100mg BID|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
11305236|NCT03094195|OG003|Outcome|EMA401 100mg BID -> Placebo BID|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
11305237|NCT03094195|OG004|Outcome|Placebo BID -> Placebo BID|Participants on placebo remained on placebo at end of treatment period (week 12)
11305238|NCT03094195|EG000|Reported Event|EMA401 25 mg b.i.d.|EMA401 25 mg b.i.d.
11305239|NCT03094195|EG001|Reported Event|EMA401 100 mg b.i.d.|EMA401 100 mg b.i.d.
11305240|NCT03094195|EG002|Reported Event|Placebo b.i.d.|Placebo b.i.d.
11305241|NCT03094195|EG003|Reported Event|EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.|EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
11305242|NCT03094195|EG004|Reported Event|EMA401 25 mg b.i.d. - Placebo b.i.d.|EMA401 25 mg b.i.d. - Placebo b.i.d.
11305243|NCT03094195|EG005|Reported Event|EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.|EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
11305244|NCT03094195|EG006|Reported Event|EMA401 100 mg b.i.d. - Placebo b.i.d.|EMA401 100 mg b.i.d. - Placebo b.i.d.
11305245|NCT03094195|EG007|Reported Event|Placebo b.i.d. - Placebo b.i.d.|Placebo b.i.d. - Placebo b.i.d.
11305246|NCT03094325|BG000|Baseline|Septal Myectomy|"Pre Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome.~Pre Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.~Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome.~Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome."
11305247|NCT03094325|FG000|Participant Flow|All Partcipants|Each of the 10 patients will have 4 measurements(OPIE & TEE before cardiopulmonary bypass and OPIE & TEE after cardiopulmonary bypass) in the septum using two techniques (TEE and OPIE Ultrasound Probe).
11305248|NCT03094325|OG000|Outcome|TEE Measured Septal Thickness Before Cardiopulmonary Bypass|Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
11305249|NCT03094325|OG001|Outcome|OPIE Measured Thickness Before Cardiopulmonary Bypass|Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome
11305250|NCT03094325|EG000|Reported Event|TEE Measured Septal Thickness Before Cardiopulmonary Bypass|Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
11305251|NCT03094325|EG001|Reported Event|OPIE Measured Thickness Before Cardiopulmonary Bypass|Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome
11305252|NCT03094611|BG000|Baseline|Treatment (Inotuzumab Ozogamicin)|"Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.~Inotuzumab Ozogamicin: Given IV"
11305253|NCT03094611|FG000|Participant Flow|Treatment (Inotuzumab Ozogamicin)|"Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.~Inotuzumab Ozogamicin: Given IV"
11305254|NCT03094611|OG000|Outcome|Treatment (Inotuzumab Ozogamicin)|"Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.~Inotuzumab Ozogamicin: Given IV"
11305255|NCT03094611|EG000|Reported Event|Treatment (Inotuzumab Ozogamicin)|"Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.~Inotuzumab Ozogamicin: Given IV"
11305256|NCT03094637|BG000|Baseline|Treatment (Azacitidine, Pembrolizumab) in Untreated Patients|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305257|NCT03094637|BG001|Baseline|Treatment (Azacitidine, Pembrolizumab) Patients With Hypomethylating Agent (HMA) Failure|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305258|NCT03094637|BG002|Baseline|Total|Total of all reporting groups
11305259|NCT03094637|FG000|Participant Flow|Treatment (Azacitidine, Pembrolizumab) in Untreated Patients|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305260|NCT03094637|FG001|Participant Flow|Treatment (Azacitidine, Pembrolizumab) Patients With Hypomethylating Agent (HMA) failureHMA Failure|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305261|NCT03094637|OG000|Outcome|Treatment (Azacitidine, Pembrolizumab) in Untreated Patients|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305262|NCT03094637|OG001|Outcome|Treatment (Azacitidine, Pembrolizumab) Patients With Hypomethylating Agent (HMA) Failure|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305263|NCT03094637|OG001|Outcome|Treatment (Azacitidine, Pembrolizumab) Patients With Hypomethylating Agent (HMA) failureHMA Failure|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305264|NCT03094637|EG000|Reported Event|Treatment (Azacitidine, Pembrolizumab) in Untreated Patients|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305265|NCT03094637|EG001|Reported Event|Treatment (Azacitidine, Pembrolizumab) Patients With Hypomethylating Agent (HMA) Failure|"Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given IV~Pembrolizumab: Given IV"
11305266|NCT03094806|BG000|Baseline|Acapella Vibratory PEP Therapy Device|"Subject will use the device 3 times a day throughout hospital stay~Acapella Vibratory PEP Therapy Device plus usual care: The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated."
11305267|NCT03094806|BG001|Baseline|Sham Acapella Vibratory PEP Device|"Subject will use the sham device 3 times a day throughout hospital stay~Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device."
11305268|NCT03094806|BG002|Baseline|Total|Total of all reporting groups
11305269|NCT03094806|FG000|Participant Flow|Acapella Vibratory PEP Therapy Device|"Subject will use the device 3 times a day throughout hospital stay~Acapella Vibratory PEP Therapy Device plus usual care: The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated."
11305270|NCT03094806|FG001|Participant Flow|Sham Acapella Vibratory PEP Device|"Subject will use the sham device 3 times a day throughout hospital stay~Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device."
11305271|NCT03094806|OG000|Outcome|Acapella Vibratory PEP Therapy Device|"Subject will use the device 3 times a day throughout hospital stay~Acapella Vibratory PEP Therapy Device plus usual care: The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated."
11305272|NCT03094806|OG001|Outcome|Sham Acapella Vibratory PEP Device|"Subject will use the sham device 3 times a day throughout hospital stay~Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device."
11305273|NCT03094806|EG000|Reported Event|Acapella Vibratory PEP Therapy Device|"Subject will use the device 3 times a day throughout hospital stay~Acapella Vibratory PEP Therapy Device plus usual care: The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated."
11305274|NCT03094806|EG001|Reported Event|Sham Acapella Vibratory PEP Device|"Subject will use the sham device 3 times a day throughout hospital stay~Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device."
11305275|NCT03095027|BG000|Baseline|Overall|FID122819 and stenfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
10971903|NCT00918203|EG000|Reported Event|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971904|NCT00918203|EG001|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
10971905|NCT00918203|EG002|Reported Event|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
10971906|NCT00918229|BG000|Baseline|Balloon Implantation|"implantation of an absorbable perirectal spacer balloon~balloon implant: Absorbable perirectal spacer implantation~Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall"
10971907|NCT00918229|FG000|Participant Flow|Balloon Implantation|"One arm study only~implantation of an absorbable perirectal spacer balloon~balloon implant: Absorbable perirectal spacer implantation~Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall"
10971908|NCT00918229|OG000|Outcome|Balloon Implantation|"implantation of an absorbable perirectal spacer balloon~balloon implant: Absorbable perirectal spacer implantation~Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall"
10971909|NCT00918229|EG000|Reported Event|Balloon Implantation|"implantation of an absorbable perirectal spacer balloon~balloon implant: Absorbable perirectal spacer implantation~Balloon implantation: Implantation of the balloon between the prostate and the anterior rectal wall"
11305276|NCT03095027|FG000|Participant Flow|FID122819, Then Stenfilcon A|FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.
11305277|NCT03095027|FG001|Participant Flow|Stenfilcon A, Then FID122819|Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.
11305278|NCT03095027|OG000|Outcome|FID112819|FID122819 contact lenses worn during Period 1 or Period 2 for 1 week
11305279|NCT03095027|OG001|Outcome|Stenfilcon A|Stenfilcon A contact lenses worn during Period 1 or Period 2 for 1 week
11305280|NCT03095027|EG000|Reported Event|FID122819|Subjects exposed to FID122819 contact lenses during Period 1 or Period 2
11305281|NCT03095027|EG001|Reported Event|Stenfilcon A|Subjects exposed to stenfilcon A contact lenses during Period 1 or Period 2
11305282|NCT03095053|BG000|Baseline|PGT-A Group|"comprehensive chromosome screening~comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.~Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA)."
11305283|NCT03095053|BG001|Baseline|Morphology Group|morphological assessment of blastocyst by light microscope
11305284|NCT03095053|BG002|Baseline|Total|Total of all reporting groups
11305285|NCT03095053|FG000|Participant Flow|PGT-A Group|"comprehensive chromosome screening~comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.~Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA)."
11305286|NCT03095053|FG001|Participant Flow|Morphology Group|morphological assessment of blastocyst by light microscope
11305287|NCT03095053|OG000|Outcome|Euploid Subgroup|"comprehensive chromosome screening~comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.~Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA)."
11305288|NCT03095053|OG001|Outcome|Morphology Group|morphological assessment of blastocyst by light microscope
11305289|NCT03095053|EG000|Reported Event|PGT-A Group|"comprehensive chromosome screening~comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.~Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA)."
11305290|NCT03095053|EG001|Reported Event|Morphology Group|morphological assessment of blastocyst by light microscope
11305291|NCT03095118|BG000|Baseline|Daratumumab|"Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses~Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses"
11305292|NCT03095118|FG000|Participant Flow|Daratumumab|"Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses~Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses"
11305293|NCT03095118|OG000|Outcome|Daratumumab|"Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses~Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses"
11305294|NCT03095118|EG000|Reported Event|Daratumumab|"Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses~Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses"
11305295|NCT03095508|BG000|Baseline|Angal S (Arm A)|Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
11305296|NCT03095508|BG001|Baseline|ANTI-ANGIN® FORMULA (Arm B)|"Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution"
11305297|NCT03095508|BG002|Baseline|Total|Total of all reporting groups
11305298|NCT03095508|FG000|Participant Flow|Angal S (Arm A)|Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
11305299|NCT03095508|FG001|Participant Flow|ANTI-ANGIN® FORMULA (Arm B)|"Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution"
11305300|NCT03095508|OG000|Outcome|Angal S (Arm A)|Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
11305301|NCT03095508|OG001|Outcome|ANTI-ANGIN® FORMULA (Arm B)|"Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution"
11305302|NCT03095508|EG000|Reported Event|Angal S (Arm A)|Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
11305303|NCT03095508|EG001|Reported Event|ANTI-ANGIN® FORMULA (Arm B)|"Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution"
10971910|NCT00918255|BG000|Baseline|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
10971911|NCT00918255|BG001|Baseline|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
10971912|NCT00918255|BG002|Baseline|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
10971913|NCT00918255|BG003|Baseline|Total|Total of all reporting groups
11305304|NCT03095521|BG000|Baseline|ANGAL|Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment.
11305305|NCT03095521|BG001|Baseline|ANTIANGIN|Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment.
11305306|NCT03095521|BG002|Baseline|Total|Total of all reporting groups
11305307|NCT03095521|FG000|Participant Flow|ANGAL|Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment.
11305308|NCT03095521|FG001|Participant Flow|ANTIANGIN|Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment.
11305309|NCT03095521|OG000|Outcome|ANGAL|Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment.
11305310|NCT03095521|OG001|Outcome|ANTIANGIN|Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment.
10971914|NCT00918255|FG000|Participant Flow|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
11305311|NCT03095521|EG000|Reported Event|ANGAL|Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment.
11305312|NCT03095521|EG001|Reported Event|ANTIANGIN|Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment.
11305313|NCT03095599|BG000|Baseline|Vaccine|IVACFLU-S: Trivalent inactivated split virion influenza vaccine
11305314|NCT03095599|BG001|Baseline|Placebo|PBS with pH 7.2; 0.5 ml/per dose
11305315|NCT03095599|BG002|Baseline|Total|Total of all reporting groups
11305316|NCT03095599|FG000|Participant Flow|Vaccine|IVACFLU-S: Trivalent inactivated split virion influenza vaccine
11305317|NCT03095599|FG001|Participant Flow|Placebo|PBS with pH 7.2; 0.5 ml/per dose
11305318|NCT03095599|OG000|Outcome|Vaccine|Received one dose of IVACFLU-S vaccine intramuscularly.
11305319|NCT03095599|OG001|Outcome|Placebo|Received one dose of placebo intramuscularly.
11305320|NCT03095599|OG000|Outcome|Vaccine|IVACFLU-S: Trivalent inactivated split virion influenza vaccine
11305321|NCT03095599|OG001|Outcome|Placebo|PBS with pH 7.2; 0.5 ml/per dose
11305322|NCT03095599|EG000|Reported Event|Vaccine|IVACFLU-S: Trivalent inactivated split virion influenza vaccine
11305323|NCT03095599|EG001|Reported Event|Placebo|PBS with pH 7.2; 0.5 ml/per dose
11305324|NCT03095638|BG000|Baseline|Total Participants: Part 1|Participants in Part 1 of the study received each of 2 treatments Five 10 mg DTG tablets direct to mouth with 240 mL of water and One 50 mg DTG tablet direct to mouth with 240 mL of water over 2 Treatment periods. There was a washout of at least 7 (-4 hours) days between the Treatment Periods 1 and 2.
11305325|NCT03095638|BG001|Baseline|Total Participants: Part 2|Participants in Part 2, of the study received each of the 3 treatments Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1), Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 1) and Conventional 25-mg DTG tablet administered as direct to mouth [reference]) over 3 Treatment Periods. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305326|NCT03095638|BG002|Baseline|Total|Total of all reporting groups
11305327|NCT03095638|FG000|Participant Flow|DTG 10 mg Followed by DTG 50 mg: Part 1|Participants in Part 1 (P1), received Five 10 milligrams (mg) Dolutegravir [DTG] tablets direct to mouth with 240 milliliters (mL) of water in Treatment Period 1 followed by One 50 mg DTG tablet direct to mouth with 240 mL of water in Treatment Period 2. There was a washout of 7(-4 hours) days between the treatment periods 1 and 2.
11305328|NCT03095638|FG001|Participant Flow|DTG 50 mg Followed by DTG 10 mg: Part 1|Participants in P1, received One 50 mg DTG tablet direct to mouth with 240 mL of water in Treatment Period 1 followed by Five 10 mg DTG tablets direct to mouth with 240 mL of water in Treatment Period 2. There was a washout of 7(-4 hours) days between the treatment periods 1 and 2.
11305329|NCT03095638|FG002|Participant Flow|DTG 5 mg (Test 1) Then DTG 5 mg (Test 2) Then by DTG 25 mg: P2|Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 2, followed by Conventional 25 mg DTG tablet administered as direct to mouth [reference]) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305330|NCT03095638|FG003|Participant Flow|DTG 5 mg Then DTG 25 mg (Reference) Then DTG 5 mg: Part 2|Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 2) in Treatment Period 1, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305331|NCT03095638|FG004|Participant Flow|DTG 25 mg (Reference) DTG 5 mg Followed by DTG 5 mg: P2|Participants in P2, received Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305332|NCT03095638|FG005|Participant Flow|DTG 5 mg Then DTG 25 mg Then DTG 5 mg: P2|Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 1, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305333|NCT03095638|FG006|Participant Flow|DTG 5 mg Followed by DTG 5 mg Followed by DTG 25 mg: Part 2|Participants in P2, received Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 1, followed by (Dispersible 5 mg DTG tablet [5 tablets] administered as a dispersion and immediately taken (test 1) in Treatment Period 2, followed by Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305334|NCT03095638|FG007|Participant Flow|DTG 25 mg Followed by DTG 5 mg Followed by DTG 5 mg: Part 2|Participants in P2, received Conventional 25 mg DTG tablet administered as direct to mouth (reference) in Treatment Period 1, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 2) in Treatment Period 2, followed by Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in Treatment Period 3. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3.
11305335|NCT03095638|OG000|Outcome|DTG 10 mg|Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305336|NCT03095638|OG001|Outcome|DTG 50 mg|Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305337|NCT03095638|OG000|Outcome|DTG 5 mg (Test 1)|Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305338|NCT03095638|OG001|Outcome|DTG 5 mg (Test 2)|Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305339|NCT03095638|OG002|Outcome|DTG 25 mg (Reference)|Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305340|NCT03095638|OG001|Outcome|DTG 50 mg|Participants in this cross-over study received treatment B in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305341|NCT03095638|OG002|Outcome|DTG 25 mg (Reference)|Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses
11305342|NCT03095638|OG000|Outcome|DTG 5 mg (Test 1)|Participants in this cross-over study received treatment C in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305343|NCT03095638|OG001|Outcome|DTG 5 mg (Test 2)|Participants in this cross-over study received treatment D in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305344|NCT03095638|OG002|Outcome|DTG 25 mg (Reference)|Participants in this cross-over study received treatment E in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305345|NCT03095638|OG000|Outcome|Treatment C|Participants in this cross-over study received treatment C in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305346|NCT03095638|OG001|Outcome|Treatment D|Participants in this cross-over study received treatment D in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305347|NCT03095638|OG002|Outcome|Treatment E|Participants in this cross-over study received treatment E in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305348|NCT03095638|EG000|Reported Event|DTG 10 mg|Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305349|NCT03095638|EG001|Reported Event|DTG 50 mg|Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305350|NCT03095638|EG002|Reported Event|DTG 5 mg (Test 1)|Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305351|NCT03095638|EG003|Reported Event|DTG 5 mg (Test 2)|Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses
11305352|NCT03095638|EG004|Reported Event|DTG 25 mg (Reference)|Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses.
11305353|NCT03095651|BG000|Baseline|T1DM MK-5160 16 Nmol/kg|Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305354|NCT03095651|BG001|Baseline|T1DM MK-5160 32 Nmol/kg|Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
10971915|NCT00918255|FG001|Participant Flow|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
11305355|NCT03095651|BG002|Baseline|T1DM MK-5160 64 Nmol/kg|Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305356|NCT03095651|BG003|Baseline|T1DM Glargine 0.4 U/kg|Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305357|NCT03095651|BG004|Baseline|T2DM MK-5160 16 Nmol/kg|Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
10971916|NCT00918255|FG002|Participant Flow|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
10971917|NCT00918255|OG000|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
10971918|NCT00918255|OG001|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
10971919|NCT00918255|OG002|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
10971920|NCT00918255|EG000|Reported Event|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
11305358|NCT03095651|BG005|Baseline|T2DM MK-5160 32 Nmol/kg|Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305359|NCT03095651|BG006|Baseline|T2DM MK-5160 64 Nmol/kg|Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305360|NCT03095651|BG007|Baseline|T2DM Glargine 0.6 U/kg|Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305361|NCT03095651|BG008|Baseline|Total|Total of all reporting groups
11305362|NCT03095651|FG000|Participant Flow|T1DM MK-5160 16 Nmol/kg|Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305363|NCT03095651|FG001|Participant Flow|T1DM MK-5160 32 Nmol/kg|Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305364|NCT03095651|FG002|Participant Flow|T1DM MK-5160 64 Nmol/kg|Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305365|NCT03095651|FG003|Participant Flow|T1DM Glargine 0.4 U/kg|Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305366|NCT03095651|FG004|Participant Flow|T2DM MK-5160 16 Nmol/kg|Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305367|NCT03095651|FG005|Participant Flow|T2DM MK-5160 32 Nmol/kg|Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305368|NCT03095651|FG006|Participant Flow|T2DM MK-5160 64 Nmol/kg|Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305369|NCT03095651|FG007|Participant Flow|T2DM Glargine 0.6 U/kg|Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305370|NCT03095651|OG000|Outcome|T1DM MK-5160 16 Nmol/kg|Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305371|NCT03095651|OG001|Outcome|T1DM MK-5160 32 Nmol/kg|Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305372|NCT03095651|OG002|Outcome|T1DM MK-5160 64 Nmol/kg|Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305373|NCT03095651|OG003|Outcome|T1DM Glargine 0.4 U/kg|Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
10971921|NCT00918255|EG001|Reported Event|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
11305374|NCT03095651|OG004|Outcome|T2DM MK-5160 16 Nmol/kg|Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
10971922|NCT00918255|EG002|Reported Event|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
10971923|NCT00918281|BG000|Baseline|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
10971924|NCT00918281|FG000|Participant Flow|1 Fluciclatide Injection|AH111585 (18F) Injection : AH111585 (18F) Injection
10971925|NCT00918281|OG000|Outcome|Imaging Session 1|Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi [370 megabecquerels (MBq)]
11305375|NCT03095651|OG005|Outcome|T2DM MK-5160 32 Nmol/kg|Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305376|NCT03095651|OG006|Outcome|T2DM MK-5160 64 Nmol/kg|Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305377|NCT03095651|OG007|Outcome|T2DM Glargine 0.6 U/kg|Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305378|NCT03095651|EG000|Reported Event|T1DM MK-5160 16 Nmol/kg|Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305379|NCT03095651|EG001|Reported Event|T1DM MK-5160 32 Nmol/kg|Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305380|NCT03095651|EG002|Reported Event|T1DM MK-5160 64 Nmol/kg|Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305381|NCT03095651|EG003|Reported Event|T1DM Glargine 0.4 U/kg|Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305382|NCT03095651|EG004|Reported Event|T2DM MK-5160 16 Nmol/kg|Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305383|NCT03095651|EG005|Reported Event|T2DM MK-5160 32 Nmol/kg|Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305384|NCT03095651|EG006|Reported Event|T2DM MK-5160 64 Nmol/kg|Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305385|NCT03095651|EG007|Reported Event|T2DM Glargine 0.6 U/kg|Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
11305386|NCT03095885|BG000|Baseline|Enrolled Set|The Enrolled Set included all subjects who were determined to be eligible for the study after screening assessments and were enrolled in the study.
11305387|NCT03095885|FG000|Participant Flow|Test Meal|controlled oxalate-rich test meal
11305388|NCT03095885|OG000|Outcome|Test Meal|controlled oxalate-rich test meal
11305389|NCT03095885|EG000|Reported Event|Test Meal|controlled oxalate-rich test meal
11305390|NCT03095976|BG000|Baseline|Test Group|"Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects.~Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects"
11305391|NCT03095976|FG000|Participant Flow|Test Group|"Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects.~Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects"
11305392|NCT03095976|OG000|Outcome|Test Group|"Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects.~Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects"
11305393|NCT03095976|EG000|Reported Event|Test Group|"Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects.~Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.: Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects"
11305394|NCT03096314|BG000|Baseline|High Dose Vitamin D Formulation|"A single dose of 540,000 IU vitamin D3 will be administered within 2 hours of randomization time.~Vitamin D3: 540,000 IU vitamin D3"
11305395|NCT03096314|BG001|Baseline|Placebo|"A single, liquid enteral placebo dose administered either orally or via naso/orogastric tube will be administered within 2 hours of randomization time.~Placebo: A single, liquid enteral dose administered either orally or via naso/orogastric tube"
11305396|NCT03096314|BG002|Baseline|Total|Total of all reporting groups
10971926|NCT00918281|OG001|Outcome|Imaging Session 2|Fluciclatide Injection (AH111585 (18F) Injection)
10971927|NCT00918281|OG002|Outcome|Relative Difference|The Relative difference between imaging sessions 1 and 2.
11305397|NCT03096314|FG000|Participant Flow|High Dose Vitamin D Formulation|Patients at high risk for ARDS and mortality with initial screening 25OHD levels < 20 ng/mL randomized to receive 540,00 IU vitamin D3 (cholecalciferol) as a single, liquid enteral dose, administered either orally or via naso/orogastric tube within 2 hours of randomization.
11305398|NCT03096314|FG001|Participant Flow|Placebo|Patients at high risk for ARDS and mortality with initial screening 25OHD levels < 20 ng/mL randomized to receive placebo (similar in appearance to the vitamin D3 treatment) as a single, liquid enteral dose, administered either orally or via naso/orogastric tube within 2 hours of randomization.
11305399|NCT03096314|OG000|Outcome|High Dose Vitamin D Formulation|"A single dose of 540,000 IU vitamin D3 will be administered within 2 hours of randomization time.~Vitamin D3: 540,000 IU vitamin D3"
11305400|NCT03096314|OG001|Outcome|Placebo|"A single, liquid enteral placebo dose administered either orally or via naso/orogastric tube will be administered within 2 hours of randomization time.~Placebo: A single, liquid enteral dose administered either orally or via naso/orogastric tube"
11305401|NCT03096314|EG000|Reported Event|High Dose Vitamin D Formulation|"A single dose of 540,000 IU vitamin D3 will be administered within 2 hours of randomization time.~Vitamin D3: 540,000 IU vitamin D3"
11305402|NCT03096314|EG001|Reported Event|Placebo|"A single, liquid enteral placebo dose administered either orally or via naso/orogastric tube will be administered within 2 hours of randomization time.~Placebo: A single, liquid enteral dose administered either orally or via naso/orogastric tube"
11305403|NCT03096353|BG000|Baseline|Naloxone, Then Placebo|"Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.~Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again."
11305404|NCT03096353|BG001|Baseline|Placebo, Then Naloxone|"Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.~Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again."
11305405|NCT03096353|BG002|Baseline|Total|Total of all reporting groups
11305406|NCT03096353|FG000|Participant Flow|Naloxone, Then Placebo|"Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.~Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again."
11305407|NCT03096353|FG001|Participant Flow|Placebo, Then Naloxone|"Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.~Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again."
11305408|NCT03096353|OG000|Outcome|Naloxone|During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.
11305409|NCT03096353|OG001|Outcome|Placebo|During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
11305410|NCT03096353|EG000|Reported Event|Naloxone|During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.
11305411|NCT03096353|EG001|Reported Event|Placebo|During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
11305412|NCT03096444|BG000|Baseline|Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle|"Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.~The 5 topical treatments are:~Topical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream"
11305413|NCT03096444|FG000|Participant Flow|Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle|"Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.~The 5 topical treatments are:~Topical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream"
11305414|NCT03096444|OG000|Outcome|Topical KeAmLi Combo|"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305415|NCT03096444|OG001|Outcome|Topical Ketamine|"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305416|NCT03096444|OG002|Outcome|Topical Amitriptyline|"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305417|NCT03096444|OG003|Outcome|Topical Lidocaine|"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305418|NCT03096444|OG004|Outcome|Topical Vehicle|"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305419|NCT03096444|EG000|Reported Event|Topical KeAmLi Combo|"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305420|NCT03096444|EG001|Reported Event|Topical Ketamine|"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305421|NCT03096444|EG002|Reported Event|Topical Amitriptyline|"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305422|NCT03096444|EG003|Reported Event|Topical Lidocaine|"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305423|NCT03096444|EG004|Reported Event|Topical Vehicle|"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.~Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."
11305424|NCT03096483|BG000|Baseline|OEC Elite Imaging Arm|"Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system~OEC Elite system: Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures"
11305425|NCT03096483|FG000|Participant Flow|OEC Elite Imaging Arm|"Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system~OEC Elite system: Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures"
11305426|NCT03096483|OG000|Outcome|OEC Elite Imaging Arm|"Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system~OEC Elite system: Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures"
11305427|NCT03096483|EG000|Reported Event|OEC Elite Imaging Arm|"Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system~OEC Elite system: Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures"
11305428|NCT03096730|BG000|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Remifentanil: Remifentanil is intravenously administrated"
10971928|NCT00918281|OG000|Outcome|Number of Adverse Events|The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).
10971929|NCT00918281|EG000|Reported Event|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
10971930|NCT00918333|BG000|Baseline|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11305429|NCT03096730|BG001|Baseline|Sufentanil|"Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Sufentanil: Sufentanil is intravenously administrated"
11305430|NCT03096730|BG002|Baseline|Dexmedetomidine|"Dexmedetomidine is intravenously administrated at a dose of 0.5ug/kg 10min before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction"
11305431|NCT03096730|BG003|Baseline|Nalmefene|"Nalmefene is intravenously administrated at a dose of 0.2ug/kg before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305432|NCT03096730|BG004|Baseline|Dexmedetomidine-Nalmefene|"A dose of 0.2ug/kg nalmefene and a dose of 0.5ug/kg dexmedetomidine for 10 minutes before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305433|NCT03096730|BG005|Baseline|Total|Total of all reporting groups
11305434|NCT03096730|FG000|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Remifentanil: Remifentanil is intravenously administrated"
11305435|NCT03096730|FG001|Participant Flow|Sufentanil|"Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Sufentanil: Sufentanil is intravenously administrated"
11305436|NCT03096730|FG002|Participant Flow|Dexmedetomidine|"Dexmedetomidine is intravenously administrated at a dose of 0.4ug/kg 10min before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction"
11305437|NCT03096730|FG003|Participant Flow|Nalmefene|"Nalmefene is intravenously administrated at a dose of 0.3ug/kg before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305438|NCT03096730|FG004|Participant Flow|Dexmedetomidine-Nalmefene|"A dose of 0.3ug/kg nalmefene and a dose of 0.4ug/kg dexmedetomidine for 10 minutes before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305439|NCT03096730|OG000|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Remifentanil: Remifentanil is intravenously administrated"
11305440|NCT03096730|OG001|Outcome|Sufentanil|"Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Sufentanil: Sufentanil is intravenously administrated"
11305441|NCT03096730|OG002|Outcome|Dexmedetomidine|"Dexmedetomidine is intravenously administrated at a dose of 0.4ug/kg 10min before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction"
11305442|NCT03096730|OG003|Outcome|Nalmefene|"Nalmefene is intravenously administrated at a dose of 0.3ug/kg before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305443|NCT03096730|OG004|Outcome|Dexmedetomidine-Nalmefene|"A dose of 0.3ug/kg nalmefene and a dose of 0.4ug/kg dexmedetomidine for 10 minutes before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305444|NCT03096730|EG000|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Remifentanil: Remifentanil is intravenously administrated"
11305445|NCT03096730|EG001|Reported Event|Sufentanil|"Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil~Normal saline: Normal saline is intravenously administrated before anesthesia induction~Sufentanil: Sufentanil is intravenously administrated"
11305446|NCT03096730|EG002|Reported Event|Dexmedetomidine|"Dexmedetomidine is intravenously administrated at a dose of 0.4ug/kg 10min before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction"
11305447|NCT03096730|EG003|Reported Event|Nalmefene|"Nalmefene is intravenously administrated at a dose of 0.3ug/kg before anesthesia induction and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
10971931|NCT00918333|BG001|Baseline|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971932|NCT00918333|BG002|Baseline|Total|Total of all reporting groups
10971933|NCT00918333|FG000|Participant Flow|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971934|NCT00918333|FG001|Participant Flow|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971935|NCT00918333|OG000|Outcome|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971936|NCT00918333|OG000|Outcome|Phase II (Lymphoma Patients Receiving 20 mg LBL589)|Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971937|NCT00918333|OG001|Outcome|Phase II (Myeloma Patients Receiving 20 mg LBH589)|Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971938|NCT00918333|OG002|Outcome|Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)|Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971939|NCT00918333|OG003|Outcome|Phase II (Myeloma Patients Receiving 30/40 mg LBH589)|Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971940|NCT00918333|EG000|Reported Event|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971941|NCT00918333|EG001|Reported Event|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10971942|NCT00918346|BG000|Baseline|Entire Study Population|Includes all 43 randomized patients (86 eyes)
10971943|NCT00918346|FG000|Participant Flow|Preserved Formulation First, Then Unpreserved Formulation|Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
10971944|NCT00918346|FG001|Participant Flow|Unpreserved Formulation First, Then Preserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)
10971945|NCT00918346|OG000|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
10971946|NCT00918346|OG001|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
10971947|NCT00918346|OG000|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
10971948|NCT00918346|OG000|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized who received at least one dose of study medication and had at least one IOP measurement
10971949|NCT00918346|OG000|Outcome|RM ANCOVA: PP Efficacy Dataset|randomized patients who completed the study per protocol (PP)
10971950|NCT00918346|EG000|Reported Event|Preserved Formulation|Tafluprost 0.0015% preserved formulation once daily for 4 weeks
10971951|NCT00918346|EG001|Reported Event|Unpreserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks
10971952|NCT00918385|BG000|Baseline|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
10971953|NCT00918385|BG001|Baseline|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
10971954|NCT00918385|BG002|Baseline|Total|Total of all reporting groups
10971955|NCT00918385|FG000|Participant Flow|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
10971956|NCT00918385|FG001|Participant Flow|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
10971957|NCT00918385|OG000|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
10971958|NCT00918385|OG001|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
10971959|NCT00918385|OG000|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
11305448|NCT03096730|EG004|Reported Event|Dexmedetomidine-Nalmefene|"A dose of 0.3ug/kg nalmefene and a dose of 0.4ug/kg dexmedetomidine for 10 minutes before anesthesia induction until 30min prior to the end of surgery and intraoperative pain management was with remifentanil~Remifentanil: Remifentanil is intravenously administrated~Dexmedetomidine: Dexmedetomidine is intravenously administrated before anesthesia induction~Nalmefene: Nalmefene is intravenously administrated before anesthesia induction"
11305449|NCT03096847|BG000|Baseline|Ribociclib + Letrozole Cohort A|"postmenopausal women, or men; naïve.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily."
11305450|NCT03096847|BG001|Baseline|Ribociclib + Letrozole Cohort B1|"premenopausal women or perimenopausal women; naïve~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305451|NCT03096847|BG002|Baseline|Ribociclib + Letrozole Cohort B2|"premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305452|NCT03096847|BG003|Baseline|Total|Total of all reporting groups
11305453|NCT03096847|FG000|Participant Flow|Ribociclib + Letrozole Cohort A|"postmenopausal women, or men; naïve.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily."
11305454|NCT03096847|FG001|Participant Flow|Ribociclib + Letrozole Cohort B1|"premenopausal women or perimenopausal women; naïve~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305455|NCT03096847|FG002|Participant Flow|Ribociclib + Letrozole Cohort B2|"premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305456|NCT03096847|OG000|Outcome|Ribociclib + Letrozole Cohort A|"postmenopausal women, or men; naïve.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily."
11305457|NCT03096847|OG001|Outcome|Ribociclib + Letrozole Cohort B1|premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
11305458|NCT03096847|OG002|Outcome|Ribociclib + Letrozole Cohort B2|premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
11305459|NCT03096847|OG003|Outcome|Total|Cohort A and Cohort B combined
11305460|NCT03096847|OG001|Outcome|Ribociclib + Letrozole Cohort B1|"premenopausal women or perimenopausal women; naïve~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305461|NCT03096847|OG002|Outcome|Ribociclib + Letrozole Cohort B2|"premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305462|NCT03096847|OG003|Outcome|Ribociclib + Letrozole Cohort B|"premenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305463|NCT03096847|OG003|Outcome|Total|Cohorts A, B1 and B2 combined
11305464|NCT03096847|OG002|Outcome|Ribociclib + Letrozole Cohort B2|premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally rec
11305465|NCT03096847|EG000|Reported Event|Ribociclib + Letrozole Cohort A|"postmenopausal women, or men; naïve.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily."
11305466|NCT03096847|EG001|Reported Event|Ribociclib + Letrozole Cohort B|"premenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305467|NCT03096847|EG002|Reported Event|Ribociclib + Letrozole Cohort B1|"premenopausal women or perimenopausal women; naïve~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
11305468|NCT03096847|EG003|Reported Event|Ribociclib + Letrozole Cohort B2|"premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.~All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.~Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly"
10971960|NCT00918385|EG000|Reported Event|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
11305469|NCT03096847|EG004|Reported Event|Total|Total
11305470|NCT03096873|BG000|Baseline|No Exercise (CON)|Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day
11305471|NCT03096873|BG001|Baseline|Exercise (EX)|"Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day~Combined Exercise Training: The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks."
11305472|NCT03096873|BG002|Baseline|Total|Total of all reporting groups
10971961|NCT00918385|EG001|Reported Event|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
10971962|NCT00918385|EG002|Reported Event|Combination Nilutamide and Dasatinib|
11305473|NCT03096873|FG000|Participant Flow|No Exercise (CON)|Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)
11305474|NCT03096873|FG001|Participant Flow|Exercise (EX)|"Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)~Combined Exercise Training: The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks."
11305475|NCT03096873|OG000|Outcome|No Exercise (CON)|Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day
11305476|NCT03096873|OG001|Outcome|Exercise (EX)|"Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day~Combined Exercise Training: The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks."
11305477|NCT03096873|OG000|Outcome|No Exercise (CON)|Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)
11305478|NCT03096873|OG001|Outcome|Exercise (EX)|"Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)~Combined Exercise Training: The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks."
11305479|NCT03096873|EG000|Reported Event|No Exercise (CON)|Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)
11305480|NCT03096873|EG001|Reported Event|Exercise (EX)|"Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day (n = 20)~Combined Exercise Training: The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks."
11305481|NCT03097029|BG000|Baseline|Pancreatic Enzymes|"All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.~Pancreatic Enzyme: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients."
11305482|NCT03097029|FG000|Participant Flow|Pancreatic Enzymes|"All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.~Pancreatic Enzyme: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients."
11305483|NCT03097029|OG000|Outcome|Pancreatic Enzymes|"All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.~Pancreatic Enzyme: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients."
11305484|NCT03097029|EG000|Reported Event|Pancreatic Enzymes|"All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.~Pancreatic Enzyme: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients."
11305485|NCT03097133|BG000|Baseline|Placebo + Standard of Care (SOC)|Participants self-administered intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) twice per week for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with SOC antidepressant treatment (determined by the physician based on clinical judgment and practice guidelines) on Day 1 and continued for the duration of the double-blind (DB) treatment phase (Days 1 to 25).
11305486|NCT03097133|BG001|Baseline|Esketamine 84 mg + SOC|Participants self-administered esketamine 84 milligram (mg) (1 spray containing esketamine 14 mg in each nostril at 0, 5, 10 minutes using 3 devices on single day) twice per week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, 25 along with SOC antidepressant treatment (determined by physician based on clinical judgment and practice guidelines) on Day 1 continued for DB treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to 56 mg was permitted if a participant was unable to tolerate intranasal esketamine 84 mg dose. Participants for whom dose was reduced continued to receive reduced dose for duration of DB treatment phase (Days 1 to 25).
10971963|NCT00918567|BG000|Baseline|Combined Therapy|atomoxetine plus behavior therapy
11305487|NCT03097133|BG002|Baseline|Total|Total of all reporting groups
11305488|NCT03097133|FG000|Participant Flow|Placebo + Standard of Care (SOC)|Participants self-administered intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) twice per week for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with SOC antidepressant treatment (determined by the physician based on clinical judgment and practice guidelines) on Day 1 and continued for the duration of the double-blind (DB) treatment phase (Days 1 to 25).
10971964|NCT00918567|BG001|Baseline|Drug Therapy|atomoxetine alone
10971965|NCT00918567|BG002|Baseline|Total|Total of all reporting groups
10971966|NCT00918567|FG000|Participant Flow|Combined Therapy|atomoxetine plus behavior therapy
10971967|NCT00918567|FG001|Participant Flow|Drug Therapy|atomoxetine alone
10971968|NCT00918567|OG000|Outcome|Combined Therapy|atomoxetine plus behavior therapy
10971969|NCT00918567|OG001|Outcome|Drug Therapy|atomoxetine alone
11305489|NCT03097133|FG001|Participant Flow|Esketamine 84 mg + SOC|Participants self-administered esketamine 84 milligram (mg) (1 spray containing esketamine 14 mg in each nostril at 0, 5, 10 minutes using 3 devices on single day) twice per week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, 25 along with SOC antidepressant treatment (determined by physician based on clinical judgment and practice guidelines) on Day 1 continued for DB treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to 56 mg was permitted if a participant was unable to tolerate intranasal esketamine 84 mg dose. Participants for whom dose was reduced continued to receive reduced dose for duration of DB treatment phase (Days 1 to 25).
11305490|NCT03097133|OG000|Outcome|Placebo + Standard of Care (SOC)|Participants self-administered intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) twice per week for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with SOC antidepressant treatment (determined by the physician based on clinical judgment and practice guidelines) on Day 1 and continued for the duration of the double-blind (DB) treatment phase (Days 1 to 25).
11305491|NCT03097133|OG001|Outcome|Esketamine 84 mg + SOC|Participants self-administered esketamine 84 milligram (mg) (1 spray containing esketamine 14 mg in each nostril at 0, 5, 10 minutes using 3 devices on single day) twice per week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, 25 along with SOC antidepressant treatment (determined by physician based on clinical judgment and practice guidelines) on Day 1 continued for DB treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to 56 mg was permitted if a participant was unable to tolerate intranasal esketamine 84 mg dose. Participants for whom dose was reduced continued to receive reduced dose for duration of DB treatment phase (Days 1 to 25).
11305492|NCT03097133|EG000|Reported Event|Placebo + Standard of Care (SOC)|Participants self-administered intranasal placebo (1 spray in each nostril at 0, 5 and 10 minutes using 3 devices on a single day) twice per week for 4 weeks on days 1, 4, 8, 11, 15, 18, 22, and 25 along with SOC antidepressant treatment (determined by the physician based on clinical judgment and practice guidelines) on Day 1 and continued for the duration of the double-blind (DB) treatment phase (Days 1 to 25).
11305493|NCT03097133|EG001|Reported Event|Esketamine 84 mg + SOC|Participants self-administered esketamine 84 milligram (mg) (1 spray containing esketamine 14 mg in each nostril at 0, 5, 10 minutes using 3 devices on single day) twice per week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, 25 along with SOC antidepressant treatment (determined by physician based on clinical judgment and practice guidelines) on Day 1 continued for DB treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to 56 mg was permitted if a participant was unable to tolerate intranasal esketamine 84 mg dose. Participants for whom dose was reduced continued to receive reduced dose for duration of DB treatment phase (Days 1 to 25).
11305494|NCT03097289|BG000|Baseline|Platelets Stored in InterSol|Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
11305495|NCT03097289|FG000|Participant Flow|Platelets Stored in InterSol|Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
11305496|NCT03097289|OG000|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol~One Test unit will be collected as a hyperconcentrated platelet product. The Test unit will be diluted to a final ratio of 65% InterSol/35% plasma and stored for 5 days."
11305497|NCT03097289|OG001|Outcome|Control Platelets|"Control Platelets~An aliquot of freshly prepared platelets derived from a whole blood sample."
11305498|NCT03097289|EG000|Reported Event|Platelets Stored in InterSol|Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
11305499|NCT03097315|BG000|Baseline|4 mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA~4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints"
11305500|NCT03097315|FG000|Participant Flow|4 mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA~4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints"
11305501|NCT03097315|OG000|Outcome|4 mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA~4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints"
11305502|NCT03097315|EG000|Reported Event|4 mg CLS-TA Suprachoriodal Injection|"Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA~4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints"
11305503|NCT03097341|BG000|Baseline|Xisomab 3G3- Dose 1|Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
11305504|NCT03097341|BG001|Baseline|Xisomab 3G3- Dose 2|Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
11305505|NCT03097341|BG002|Baseline|Xisomab 3G3- Dose 3|Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
11305506|NCT03097341|BG003|Baseline|Xisomab 3G3- Dose 4|Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
11305507|NCT03097341|BG004|Baseline|Placebo|Participants received a single intravenous dose of placebo.
11305508|NCT03097341|BG005|Baseline|Total|Total of all reporting groups
11305509|NCT03097341|FG000|Participant Flow|Xisomab 3G3- Dose 1|Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
11305510|NCT03097341|FG001|Participant Flow|Xisomab 3G3- Dose 2|Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
11305511|NCT03097341|FG002|Participant Flow|Xisomab 3G3- Dose 3|Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
11305512|NCT03097341|FG003|Participant Flow|Xisomab 3G3- Dose 4|Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
11305513|NCT03097341|FG004|Participant Flow|Placebo|Participants received a single intravenous dose of placebo.
11305514|NCT03097341|OG000|Outcome|Xisomab 3G3- Dose 1|Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
11305515|NCT03097341|OG001|Outcome|Xisomab 3G3- Dose 2|Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
11305516|NCT03097341|OG002|Outcome|Xisomab 3G3- Dose 3|Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
11305517|NCT03097341|OG003|Outcome|Xisomab 3G3- Dose 4|Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
11305518|NCT03097341|OG004|Outcome|Placebo|Participants received a single intravenous dose of placebo.
11305519|NCT03097341|EG000|Reported Event|Xisomab 3G3- Dose 1|Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
11305520|NCT03097341|EG001|Reported Event|Xisomab 3G3- Dose 2|Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
11305521|NCT03097341|EG002|Reported Event|Xisomab 3G3- Dose 3|Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
11305522|NCT03097341|EG003|Reported Event|Xisomab 3G3- Dose 4|Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
11305523|NCT03097341|EG004|Reported Event|Placebo|Participants received a single intravenous dose of placebo.
11305524|NCT03097484|BG000|Baseline|Standard Therapy ALONE|These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
11305525|NCT03097484|BG001|Baseline|Standard Therapy Plus Aromatherapy|"These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.~lavender and chamomile essential oils: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads."
11305526|NCT03097484|BG002|Baseline|Total|Total of all reporting groups
11305527|NCT03097484|FG000|Participant Flow|Standard Therapy ALONE|These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
11305528|NCT03097484|FG001|Participant Flow|Standard Therapy Plus Aromatherapy|"These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.~lavender and chamomile essential oils: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads."
11305529|NCT03097484|OG000|Outcome|Standard Therapy ALONE|These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
11305530|NCT03097484|OG001|Outcome|Standard Therapy Plus Aromatherapy|"These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.~lavender and chamomile essential oils: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads."
11305531|NCT03097484|EG000|Reported Event|Standard Therapy ALONE|These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
11305532|NCT03097484|EG001|Reported Event|Standard Therapy Plus Aromatherapy|"These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.~lavender and chamomile essential oils: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads."
11305533|NCT03097588|BG000|Baseline|Supportive Care (NEPA)|"Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6.~Netupitant: 300 mg, QD, Given PO Palonosetron Hydrochloride: 0.5 mg, QD, Given PO Questionnaire Administration: Ancillary studies"
11305534|NCT03097588|FG000|Participant Flow|Supportive Care (NEPA)|"Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6.~Netupitant: 300 mg, QD, Given PO~Palonosetron Hydrochloride: 0.5 mg, QD, Given PO~Questionnaire Administration: Ancillary studies"
11305535|NCT03097588|OG000|Outcome|Supportive Care (NEPA)|"Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6.~Netupitant: 300 mg, QD, Given PO Palonosetron Hydrochloride: 0.5 mg, QD, Given PO Questionnaire Administration: Ancillary studies"
11305536|NCT03097588|EG000|Reported Event|Supportive Care (NEPA)|"Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6.~Netupitant: 300 mg, QD, Given PO Palonosetron Hydrochloride: 0.5 mg, QD, Given PO Questionnaire Administration: Ancillary studies"
11305537|NCT03097614|BG000|Baseline|TrueTear|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
11305538|NCT03097614|FG000|Participant Flow|TrueTear|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
11305539|NCT03097614|OG000|Outcome|TrueTear|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
11305540|NCT03097614|EG000|Reported Event|TrueTear|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
11305541|NCT03097653|BG000|Baseline|Decision-aid|Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.
11305542|NCT03097653|BG001|Baseline|Standard Information|Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
11305543|NCT03097653|BG002|Baseline|Total|Total of all reporting groups
11305544|NCT03097653|FG000|Participant Flow|Decision-aid|Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.
10971970|NCT00918567|EG000|Reported Event|Combined Therapy|atomoxetine plus behavior therapy
10971971|NCT00918567|EG001|Reported Event|Drug Therapy|atomoxetine alone
11305545|NCT03097653|FG001|Participant Flow|Standard Information|Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
11305546|NCT03097653|OG000|Outcome|Decision-aid|Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.
11305547|NCT03097653|OG001|Outcome|Standard Information|Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
11305548|NCT03097653|EG000|Reported Event|Decision-aid|Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.
11305549|NCT03097653|EG001|Reported Event|Standard Information|Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
11305550|NCT03097783|BG000|Baseline|Restylane Perlane Lidocaine|"Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface~Restylane Perlane Lidocaine: Intradermal injection"
11305551|NCT03097783|BG001|Baseline|No Intervention Arm|No treatment
11305552|NCT03097783|BG002|Baseline|Total|Total of all reporting groups
11305553|NCT03097783|FG000|Participant Flow|Restylane Perlane Lidocaine|"Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface~Restylane Perlane Lidocaine: Intradermal injection"
11305554|NCT03097783|FG001|Participant Flow|No Intervention Arm|No treatment
11305555|NCT03097783|OG000|Outcome|Restylane Perlane Lidocaine|"Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface~Restylane Perlane Lidocaine: Intradermal injection"
11305556|NCT03097783|OG001|Outcome|No Intervention Arm|No treatment
11305557|NCT03097783|EG000|Reported Event|Restylane Perlane Lidocaine|"Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface~Restylane Perlane Lidocaine: Intradermal injection"
11305558|NCT03097783|EG001|Reported Event|No Intervention Arm|No treatment
11305559|NCT03097861|BG000|Baseline|Placebo|Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.
11305560|NCT03097861|BG001|Baseline|Lubiprostone Sprinkle|Lubiprostone 24 mcg sprinkle BID for 7 days.
11305561|NCT03097861|BG002|Baseline|Lubiprostone Capsule|Lubiprostone 24 mcg capsule BID for 7 days.
11305562|NCT03097861|BG003|Baseline|Total|Total of all reporting groups
11305563|NCT03097861|FG000|Participant Flow|Placebo|Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.
11305564|NCT03097861|FG001|Participant Flow|Lubiprostone Sprinkle|Lubiprostone 24 mcg sprinkle BID for 7 days.
11305565|NCT03097861|FG002|Participant Flow|Lubiprostone Capsule|Lubiprostone 24 mcg capsule BID for 7 days.
11305566|NCT03097861|OG000|Outcome|Placebo|Matching placebo
11305567|NCT03097861|OG001|Outcome|Lubiprostone Sprinkle|Lubiprostone 24 mcg sprinkle twice daily (BID) for 7 days.
11305568|NCT03097861|OG002|Outcome|Lubiprostone Capsule|Lubiprostone 24 mcg capsule BID for 7 days.
11305569|NCT03097861|OG000|Outcome|Placebo|Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.
10971972|NCT00918580|BG000|Baseline|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
11305570|NCT03097861|OG001|Outcome|Lubiprostone Sprinkle|Lubiprostone 24 mcg sprinkle BID for 7 days.
11305571|NCT03097861|EG000|Reported Event|Placebo|Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.
11305572|NCT03097861|EG001|Reported Event|Lubiprostone Sprinkle|Lubiprostone 24 mcg sprinkle BID for 7 days.
11305573|NCT03097861|EG002|Reported Event|Lubiprostone Capsule|Lubiprostone 24 mcg capsule BID for 7 days.
11305574|NCT03098030|BG000|Baseline|Part 1: Dinutuximab + Irinotecan|"Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305575|NCT03098030|BG001|Baseline|Part 2: Dinutuximab + Irinotecan|"Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305576|NCT03098030|BG002|Baseline|Part 2: Irinotecan|"Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.~Irinotecan: Irinotecan injection, IV infusion"
11305577|NCT03098030|BG003|Baseline|Part 2: Topotecan|"Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.~Topotecan: Topotecan for injection"
11305578|NCT03098030|BG004|Baseline|Total|Total of all reporting groups
11305579|NCT03098030|FG000|Participant Flow|Part 1: Dinutuximab + Irinotecan|"Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305580|NCT03098030|FG001|Participant Flow|Part 2: Dinutuximab + Irinotecan|"Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305581|NCT03098030|FG002|Participant Flow|Part 2: Irinotecan|"Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.~Irinotecan: Irinotecan injection, IV infusion"
11305582|NCT03098030|FG003|Participant Flow|Part 2: Topotecan|"Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.~Topotecan: Topotecan for injection"
11305583|NCT03098030|OG000|Outcome|Part 2: Dinutuximab + Irinotecan|"Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305584|NCT03098030|OG001|Outcome|Part 2: Irinotecan|"Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.~Irinotecan: Irinotecan injection, IV infusion"
11305585|NCT03098030|OG002|Outcome|Part 2: Topotecan|"Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.~Topotecan: Topotecan for injection"
11305586|NCT03098030|EG000|Reported Event|Part 1: Dinutuximab + Irinotecan|"Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305587|NCT03098030|EG001|Reported Event|Part 2: Dinutuximab + Irinotecan|"Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 or Grade 2/3 that in the view of the Investigator is adequately managed and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.~Dinutuximab: Dinutuximab injection, for intravenous (IV) use~Irinotecan: Irinotecan injection, IV infusion"
11305588|NCT03098030|EG002|Reported Event|Part 2: Irinotecan|"Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.~Irinotecan: Irinotecan injection, IV infusion"
11305589|NCT03098030|EG003|Reported Event|Part 2: Topotecan|"Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.~Topotecan: Topotecan for injection"
11305590|NCT03098173|BG000|Baseline|Early Colonoscopy|"Performance of prepared colonoscopy within 24 h of arrival~Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival"
11305591|NCT03098173|BG001|Baseline|Elective Colonoscopy|"Performance of prepared colonoscopy between 24 and 96 h after arrival~Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival"
11305592|NCT03098173|BG002|Baseline|Total|Total of all reporting groups
11305593|NCT03098173|FG000|Participant Flow|Elective Colonoscopy|"Performance of prepared colonoscopy between 24 and 96 h after arrival~Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival"
11305594|NCT03098173|FG001|Participant Flow|Early Colonoscopy|"Performance of prepared colonoscopy within 24 h of arrival~Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival"
11305595|NCT03098173|OG000|Outcome|Early Colonoscopy|"Performance of prepared colonoscopy within 24 h of arrival~Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival"
11305596|NCT03098173|OG001|Outcome|Elective Colonoscopy|"Performance of prepared colonoscopy between 24 and 96 h after arrival~Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival"
11305597|NCT03098173|OG000|Outcome|Elective Colonoscopy|"Performance of prepared colonoscopy between 24 and 96 h after arrival~Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival"
11305598|NCT03098173|OG001|Outcome|Early Colonoscopy|"Performance of prepared colonoscopy within 24 h of arrival~Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival"
11305599|NCT03098173|EG000|Reported Event|Early Colonoscopy|"Performance of prepared colonoscopy within 24 h of arrival~Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival"
11305600|NCT03098173|EG001|Reported Event|Elective Colonoscopy|"Performance of prepared colonoscopy between 24 and 96 h after arrival~Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival"
11305601|NCT03098420|BG000|Baseline|Control Group|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine.~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305602|NCT03098420|BG001|Baseline|2mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine.~2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305603|NCT03098420|BG002|Baseline|4mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine.~4mg Dexamethasone: 1 mL (4mg) of dexamethasone~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride"
11305604|NCT03098420|BG003|Baseline|Total|Total of all reporting groups
11305605|NCT03098420|FG000|Participant Flow|Control Group|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine.~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305606|NCT03098420|FG001|Participant Flow|2mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine.~2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305607|NCT03098420|FG002|Participant Flow|4mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine.~4mg Dexamethasone: 1 mL (4mg) of dexamethasone~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride"
11305608|NCT03098420|OG000|Outcome|Control Group|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine.~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305609|NCT03098420|OG001|Outcome|2mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine.~2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
10971973|NCT00918580|FG000|Participant Flow|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
11305610|NCT03098420|OG002|Outcome|4mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine.~4mg Dexamethasone: 1 mL (4mg) of dexamethasone~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride"
11305611|NCT03098420|EG000|Reported Event|Control Group|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine.~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305612|NCT03098420|EG001|Reported Event|2mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine.~2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride~Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine"
11305613|NCT03098420|EG002|Reported Event|4mg Dexamethasone|"20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine.~4mg Dexamethasone: 1 mL (4mg) of dexamethasone~Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine~Morphine~Bupivacaine Hydrochloride"
11305614|NCT03098433|BG000|Baseline|Three Treatments in Random Order|"Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.~Information on the order of treatments was not collected.~Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.~At the second study visit one of the remaining two treatments will be randomly selected and administered.~At the third study visit the final treatment will be administered.~The order of administration will not be tracked."
11305615|NCT03098433|FG000|Participant Flow|Three Treatments in Random Order|"Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.~Information on the order of treatments was not collected.~Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.~At the second study visit one of the remaining two treatments will be randomly selected and administered.~At the third study visit the final treatment will be administered.~The order of administration will not be analyzed therefore all participants are part of a single arm."
11305616|NCT03098433|OG000|Outcome|Three Treatments in Random Order|"Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order~Information on the order of treatments was not collected.~Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.~At the second study visit one of the remaining two treatments will be randomly selected and administered.~At the third study visit the final treatment will be administered.~The order of administration will not be tracked."
11305617|NCT03098433|OG000|Outcome|Three Treatments in Random Order|"Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.~Information on the order of treatments was not collected.~Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.~At the second study visit one of the remaining two treatments will be randomly selected and administered.~At the third study visit the final treatment will be administered.~The order of administration will not be tracked."
11305618|NCT03098433|EG000|Reported Event|Three Treatments in Random Order|"Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.~Information on the order of treatments was not collected.~Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.~At the second study visit one of the remaining two treatments will be randomly selected and administered.~At the third study visit the final treatment will be administered.~The order of administration will not be tracked."
11305619|NCT03098550|BG000|Baseline|Nivolumab + Daratumumab (TNBC)|Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305620|NCT03098550|BG001|Baseline|Nivolumab + Daratumumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305621|NCT03098550|BG002|Baseline|Nivolumab + Daratumumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305622|NCT03098550|BG003|Baseline|Total|Total of all reporting groups
11305623|NCT03098550|FG000|Participant Flow|Nivolumab + Daratumumab (TNBC)|Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305624|NCT03098550|FG001|Participant Flow|Nivolumab + Daratumumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305625|NCT03098550|FG002|Participant Flow|Nivolumab + Daratumumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305626|NCT03098550|OG000|Outcome|Nivolumab + Daratumumab (TNBC)|Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305627|NCT03098550|OG001|Outcome|Nivolumab + Daratumumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305628|NCT03098550|OG002|Outcome|Nivolumab + Daratumumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305629|NCT03098550|OG001|Outcome|Nivolumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305630|NCT03098550|OG002|Outcome|Nivolumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305631|NCT03098550|OG001|Outcome|Daratumumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305632|NCT03098550|OG002|Outcome|Daratumumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305633|NCT03098550|EG000|Reported Event|Nivolumab + Daratumumab (TNBC)|Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305634|NCT03098550|EG001|Reported Event|Nivolumab + Daratumumab (NSCLC)|Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305635|NCT03098550|EG002|Reported Event|Nivolumab + Daratumumab (PAC)|Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
11305636|NCT03098615|BG000|Baseline|Baseline Group|Subject with age >18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness <= 3.0 mm, positive potassium hydroxide (KOH) or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish
11305637|NCT03098615|FG000|Participant Flow|Jublia Treatment Group|The intervention to be administered is Jublia (Efinaconazole 10% Topical Solution). The frequency of administration is daily to the affected toes.
11305638|NCT03098615|OG000|Outcome|Baseline Group|Subject with age >18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness <= 3.0 mm, positive KOH or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish.
11305639|NCT03098615|OG000|Outcome|Jublia (Efinaconazole 10% Topical Solution) + Nail Polish|"Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.~Jublia (Efinaconazole 10% Topical Solution): Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma."
11305640|NCT03098615|EG000|Reported Event|Baseline Group|Subject with age >18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness <= 3.0 mm, positive KOH or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish
11305641|NCT03098641|BG000|Baseline|Pelvic Organ Prolapse Repair|Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
11305642|NCT03098641|FG000|Participant Flow|Pelvic Organ Prolapse Repair|Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
11305643|NCT03098641|OG000|Outcome|Pelvic Organ Prolapse Repair|Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
11305644|NCT03098641|EG000|Reported Event|Pelvic Organ Prolapse Repair|Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
11305645|NCT03098745|BG000|Baseline|Overall Study|Participants are randomized to wear omafilcon A lens pair, Somofilcon A lens pair, Omafilcon A - Proclear PC bilaterally for 1 hour during the study on separate days
11305646|NCT03098745|FG000|Participant Flow|Omafilcon A, Omafilcon A - Proclear (PC), Somofilcon A|Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then Somofilcon A lens pair bilaterally for 1 hour.
11305647|NCT03098745|FG001|Participant Flow|Omafilcon A, Somofilcon A, Omafilcon A - Proclear (PC)|Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then Somofilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour.
11305648|NCT03098745|FG002|Participant Flow|Somofilcon A, Omafilcon A - Proclear (PC), Omafilcon A|Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then omafilcon A lens pair bilaterally for 1 hour.
11305649|NCT03098745|FG003|Participant Flow|Somofilcon A, Omafilcon A, Omafilcon A- Proclear (PC)|Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour.
11305650|NCT03098745|FG004|Participant Flow|Omafilcon A - Proclear (PC), Omafilcon A, Somofilcon A|Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then somofilcon A lens pair bilaterally for 1 hour.
11305651|NCT03098745|FG005|Participant Flow|Omafilcon A - Proclear (PC), Somofilcon A, Omafilcon A|Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then somofilcon A, then omafilcon A lens pair bilaterally for 1 hour.
11305652|NCT03098745|OG000|Outcome|Omafilcon A|"Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.~Omafilcon A: contact lens"
11305653|NCT03098745|OG001|Outcome|Somofilcon A|"Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.~Somofilcon A: contact lens"
11305654|NCT03098745|OG002|Outcome|Omafilcon A - Proclear (PC)|"Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.~Omafilcon A - Proclear (PC): contact lens"
11305655|NCT03098745|OG000|Outcome|Overall Study|Investigator's preference of lens based on fit
11305656|NCT03098745|EG000|Reported Event|Omafilcon A|"Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.~Omafilcon A: contact lens"
11305657|NCT03098745|EG001|Reported Event|Somofilcon A|"Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.~Somofilcon A: contact lens"
11305658|NCT03098745|EG002|Reported Event|Omafilcon A - Proclear (PC)|"Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.~Omafilcon A - Proclear (PC): contact lens"
11305659|NCT03098966|BG000|Baseline|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
11305660|NCT03098966|FG000|Participant Flow|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
11305661|NCT03098966|OG000|Outcome|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
11305662|NCT03098966|EG000|Reported Event|Trial Of Labour After Caesarean Section|"The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:~-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy~-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any~-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)~-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality"
11305663|NCT03098979|BG000|Baseline|Placebo|Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
11305664|NCT03098979|BG001|Baseline|Neladenoson Bialanate 5 mg|Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
11305665|NCT03098979|BG002|Baseline|Neladenoson Bialanate 10 mg|Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
11305666|NCT03098979|BG003|Baseline|Neladenoson Bialanate 20 mg|Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
11305667|NCT03098979|BG004|Baseline|Neladenoson Bialanate 30 mg|Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
11305668|NCT03098979|BG005|Baseline|Neladenoson Bialanate 40 mg|Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
11305669|NCT03098979|BG006|Baseline|Total|Total of all reporting groups
11305670|NCT03098979|FG000|Participant Flow|Placebo|Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
11305671|NCT03098979|FG001|Participant Flow|Neladenoson Bialanate 5 mg|Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
11305672|NCT03098979|FG002|Participant Flow|Neladenoson Bialanate 10 mg|Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
11305673|NCT03098979|FG003|Participant Flow|Neladenoson Bialanate 20 mg|Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
11305674|NCT03098979|FG004|Participant Flow|Neladenoson Bialanate 30 mg|Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
11305675|NCT03098979|FG005|Participant Flow|Neladenoson Bialanate 40 mg|Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
11305676|NCT03098979|OG000|Outcome|Placebo|Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
11305677|NCT03098979|OG001|Outcome|Neladenoson Bialanate 5 mg|Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
11305678|NCT03098979|OG002|Outcome|Neladenoson Bialanate 10 mg|Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
11305679|NCT03098979|OG003|Outcome|Neladenoson Bialanate 20 mg|Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
11305680|NCT03098979|OG004|Outcome|Neladenoson Bialanate 30 mg|Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
11305681|NCT03098979|OG005|Outcome|Neladenoson Bialanate 40 mg|Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
11305682|NCT03098979|EG000|Reported Event|Placebo|Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks.
11305683|NCT03098979|EG001|Reported Event|Neladenoson Bialanate 5mg|Subjects received 5 mg of neladenoson bialanate tablets orally for 20 weeks.
11305684|NCT03098979|EG002|Reported Event|Neladenoson Bialanate 10mg|Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks.
11305685|NCT03098979|EG003|Reported Event|Neladenoson Bialanate 20mg|Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks.
11305686|NCT03098979|EG004|Reported Event|Neladenoson Bialanate 30mg|Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks.
11305687|NCT03098979|EG005|Reported Event|Neladenoson Bialanate 40mg|Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks.
11305688|NCT03099096|BG000|Baseline|Mepolizumab Liquid Autoinjector|Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
11305689|NCT03099096|FG000|Participant Flow|Mepolizumab Liquid Autoinjector|Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
11305690|NCT03099096|OG000|Outcome|Mepolizumab Liquid Autoinjector|Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
11305691|NCT03099096|EG000|Reported Event|Mepolizumab Liquid Autoinjector|Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
11305692|NCT03099161|BG000|Baseline|Preladenant 25 mg BID|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305693|NCT03099161|BG001|Baseline|Preladenant 50 mg BID|Participants received 50 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305694|NCT03099161|BG002|Baseline|Preladenant 25 mg BID + Pembrolizumab 200 mg|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 and pembrolizumab 200 mg administered by IV infusion on Day 1 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305695|NCT03099161|BG003|Baseline|Total|Total of all reporting groups
11305696|NCT03099161|FG000|Participant Flow|Preladenant 25 mg Twice a Day (BID)|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305697|NCT03099161|FG001|Participant Flow|Preladenant 50 mg BID|Participants received 50 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305698|NCT03099161|FG002|Participant Flow|Preladenant 25 mg BID + Pembrolizumab 200 mg|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 and pembrolizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305699|NCT03099161|OG000|Outcome|Preladenant 25 mg BID|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305700|NCT03099161|OG001|Outcome|Preladenant 50 mg BID|Participants received 50 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305701|NCT03099161|OG002|Outcome|Preladenant 25 mg BID + Pembrolizumab 200 mg|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 and pembrolizumab 200 mg administered by IV infusion on Day 1 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305702|NCT03099161|EG000|Reported Event|Preladenant 25 mg BID|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305703|NCT03099161|EG001|Reported Event|Preladenant 50 mg BID|Participants received 50 mg of preladenant administered by oral capsule BID on Days 1 through 21 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305704|NCT03099161|EG002|Reported Event|Preladenant 25 mg BID + Pembrolizumab 200 mg|Participants received 25 mg of preladenant administered by oral capsule BID on Days 1 through 21 and pembrolizumab 200 mg administered by IV infusion on Day 1 of each 21-day cycle. Participants were to receive up to 35 cycles of study treatment.
11305705|NCT03099187|BG000|Baseline|Pirfenidone|Participants received pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24. After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305706|NCT03099187|BG001|Baseline|Placebo|Participants received matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24. After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305707|NCT03099187|BG002|Baseline|Total|Total of all reporting groups
11305708|NCT03099187|FG000|Participant Flow|Pirfenidone|Participants received pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305709|NCT03099187|FG001|Participant Flow|Placebo|Participants received matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305710|NCT03099187|FG002|Participant Flow|Open-Label Treatment (Pirfenidone)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305711|NCT03099187|FG003|Participant Flow|Open-Label Treatment (Placebo)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305712|NCT03099187|OG000|Outcome|Pirfenidone|Participants received pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305713|NCT03099187|OG001|Outcome|Placebo|Participants received matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305714|NCT03099187|OG000|Outcome|Open-Label Treatment (Pirfenidone)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305715|NCT03099187|OG001|Outcome|Open-Label Treatment (Placebo)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305716|NCT03099187|EG000|Reported Event|Pirfenidone|Participants received pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305717|NCT03099187|EG001|Reported Event|Placebo|Participants received matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
11305718|NCT03099187|EG002|Reported Event|Open-Label Treatment (Pirfenidone)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305719|NCT03099187|EG003|Reported Event|Open-Label Treatment (Placebo)|After participants completed the double-blind treatment period and the follow-up visit at Week 28, they were offered the option to receive open-label pirfenidone within the trial protocol in a safety follow-up period of up to 12 months. A final follow-up visit was performed at the end of the safety period, 28 days after the last open-label dose.
11305720|NCT03099369|BG000|Baseline|Daily Step-based Exercise Group|"The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking.~Week 1: walk at least 3,000 steps every day.~Week 2: walk at least 3,500 steps every day.~Week 3: walk at least 4,000 steps every day.~Week 4: walk at least 4,500 steps every day.~Weeks 5-12: walk at least 5,000 steps every day.~Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305721|NCT03099369|BG001|Baseline|Symptom-based Exercise Group|"The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).~Walk on a flat surface at a constant speed until there is mild to moderate pain~Rest until the pain has completely ceased~Resume walking at the same speed~Increase the speed when you can walk 8 minutes without stopping for leg symptoms~Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.~Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305722|NCT03099369|BG002|Baseline|Total|Total of all reporting groups
11305723|NCT03099369|FG000|Participant Flow|Daily Step-based Exercise Group|"The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking.~Week 1: walk at least 3,000 steps every day.~Week 2: walk at least 3,500 steps every day.~Week 3: walk at least 4,000 steps every day.~Week 4: walk at least 4,500 steps every day.~Weeks 5-12: walk at least 5,000 steps every day.~Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305724|NCT03099369|FG001|Participant Flow|Symptom-based Exercise Group|"The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).~Walk on a flat surface at a constant speed until there is mild to moderate pain~Rest until the pain has completely ceased~Resume walking at the same speed~Increase the speed when you can walk 8 minutes without stopping for leg symptoms~Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.~Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305725|NCT03099369|OG000|Outcome|Daily Step-based Exercise Group|"The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor used for tracking.~Week 1: walk at least 3,000 steps every day.~Week 2: walk at least 3,500 steps every day.~Week 3: walk at least 4,000 steps every day.~Week 4: walk at least 4,500 steps every day.~Weeks 5-12: walk at least 5,000 steps every day.~Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
10971974|NCT00918580|OG000|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
10971975|NCT00918580|EG000|Reported Event|13vPnC Dose 1|Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
10971976|NCT00918580|EG001|Reported Event|13vPnC Dose 2|Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
11305726|NCT03099369|OG001|Outcome|Symptom-based Exercise Group|"The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).~Walk on a flat surface at a constant speed until there is mild to moderate pain~Rest until the pain has completely ceased~Resume walking at the same speed~Increase the speed when you can walk 8 minutes without stopping for leg symptoms~Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.~Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305727|NCT03099369|OG000|Outcome|Daily Step-based Exercise Group|"The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking.~Week 1: walk at least 3,000 steps every day.~Week 2: walk at least 3,500 steps every day.~Week 3: walk at least 4,000 steps every day.~Week 4: walk at least 4,500 steps every day.~Weeks 5-12: walk at least 5,000 steps every day.~Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305728|NCT03099369|EG000|Reported Event|Daily Step-based Exercise Group|"The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking.~Week 1: walk at least 3,000 steps every day.~Week 2: walk at least 3,500 steps every day.~Week 3: walk at least 4,000 steps every day.~Week 4: walk at least 4,500 steps every day.~Weeks 5-12: walk at least 5,000 steps every day.~Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305729|NCT03099369|EG001|Reported Event|Symptom-based Exercise Group|"The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).~Walk on a flat surface at a constant speed until there is mild to moderate pain~Rest until the pain has completely ceased~Resume walking at the same speed~Increase the speed when you can walk 8 minutes without stopping for leg symptoms~Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.~Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.~Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only"
11305730|NCT03099538|BG000|Baseline|Ixekizumab|"Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.~Ixekizumab: Subcutaneous injection"
11305731|NCT03099538|FG000|Participant Flow|Ixekizumab|"Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.~Ixekizumab: Subcutaneous injection"
11305732|NCT03099538|OG000|Outcome|Ixekizumab|"Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.~Ixekizumab: Subcutaneous injection"
11305733|NCT03099538|EG000|Reported Event|Ixekizumab|"Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.~Ixekizumab: Subcutaneous injection"
11305734|NCT03099655|BG000|Baseline|Attain Stability Quad Lead|Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
11305735|NCT03099655|FG000|Participant Flow|Attain Stability Quad Lead|"Attain Stability Quad Lead (Model 4798) - Single arm study.~Attain Stability Quad Left Ventricular Pacing Lead: cardiac stimulation"
11305736|NCT03099655|OG000|Outcome|Attain Stability Quad Lead|Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
11305737|NCT03099655|OG000|Outcome|Attain Stability Quad Lead|All subjects who are successfully implanted with Model 4798 lead and with valid pacing data collected at 6 months post-implant follow-up visit.
11305738|NCT03099655|OG000|Outcome|Attain Stability Quad Lead|All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.
11305739|NCT03099655|OG000|Outcome|Attain Stability Quad Lead|All subjects who are successfully implanted with a Model 4798 lead.
11305740|NCT03099655|EG000|Reported Event|Attain Stability Quad Lead|Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
11305741|NCT03099694|BG000|Baseline|nCPAP|infants receive primary non-invasive respiratory support by mean of nCPAP
11305742|NCT03099694|BG001|Baseline|nHFOV|infants receive primary non-invasive respiratory support by mean of NIPPV
11305743|NCT03099694|BG002|Baseline|Total|Total of all reporting groups
11305744|NCT03099694|FG000|Participant Flow|nCPAP|infants receive primary non-invasive respiratory support by mean of nCPAP
11305745|NCT03099694|FG001|Participant Flow|nHFOV|infants receive primary non-invasive respiratory support by mean of NHFOV
11305746|NCT03099694|OG000|Outcome|nCPAP|infants receive primary non-invasive respiratory support by mean of nCPAP
11305747|NCT03099694|OG001|Outcome|nHFOV|infants receive primary non-invasive respiratory support by mean of NHFOV
11305748|NCT03099694|OG001|Outcome|nHFOV|infants receive primary non-invasive respiratory support by mean of NIPPV
11305749|NCT03099694|EG000|Reported Event|nHFOV|infants receive primary non-invasive respiratory support by mean of nHFOV
11305750|NCT03099694|EG001|Reported Event|nCPAP|infants receive primary non-invasive respiratory support by mean of nCPAP
11305751|NCT03100058|BG000|Baseline|LIK066 2.5mg qd (Epoch 3)|LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
11305752|NCT03100058|BG001|Baseline|LIK066 10mg qd (Epoch 3)|LIK066 10mg qd (once daily) dosing frequency for 24 weeks
11305753|NCT03100058|BG002|Baseline|LIK066 50mg qd (Epoch 3)|LIK066 50mg qd (once daily) dosing frequency for 24 weeks
11305754|NCT03100058|BG003|Baseline|LIK066 150mg qd (Epoch 3)|LIK066 150mg qd (once daily) dosing frequency for 24 weeks
11305755|NCT03100058|BG004|Baseline|LIK066 2.5mg Bid (Epoch 3)|LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
11305756|NCT03100058|BG005|Baseline|LIK066 5mg Bid (Epoch 3)|LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
11305757|NCT03100058|BG006|Baseline|LIK066 25mg Bid (Epoch 3)|LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
11305758|NCT03100058|BG007|Baseline|LIK066 50mg Bid (Epoch 3)|LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
11305759|NCT03100058|BG008|Baseline|Placebo (Epoch 3)|Matching placebo tablets for 24 weeks
11305760|NCT03100058|BG009|Baseline|Total|Total of all reporting groups
11305761|NCT03100058|FG000|Participant Flow|LIK066 2.5mg qd (Epoch 3)|LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
11305762|NCT03100058|FG001|Participant Flow|LIK066 10mg qd (Epoch 3)|LIK066 10mg qd (once daily) dosing frequency for 24 weeks
11305763|NCT03100058|FG002|Participant Flow|LIK066 50mg qd (Epoch 3)|LIK066 50mg qd (once daily) dosing frequency for 24 weeks
11305764|NCT03100058|FG003|Participant Flow|LIK066 150mg qd (Epoch 3)|LIK066 150mg qd (once daily) dosing frequency for 24 weeks
11305765|NCT03100058|FG004|Participant Flow|LIK066 2.5mg Bid (Epoch 3)|LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
11305766|NCT03100058|FG005|Participant Flow|LIK066 5mg Bid (Epoch 3)|LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
11305767|NCT03100058|FG006|Participant Flow|LIK066 25mg Bid (Epoch 3)|LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
11305768|NCT03100058|FG007|Participant Flow|LIK066 50mg Bid (Epoch 3)|LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
11305769|NCT03100058|FG008|Participant Flow|Placebo (Epoch 3)|Matching placebo tablets for 24 weeks
11305770|NCT03100058|FG009|Participant Flow|LIK066 qd/LIK066 25 mg qd (Epoch 4)|LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd
11305771|NCT03100058|FG010|Participant Flow|LIK066 Bid/LIK066 35 mg qd (Epoch 4)|LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd
11305772|NCT03100058|FG011|Participant Flow|Placebo/LIK066 25 mg qd (Epoch 4)|Matching placebo tablets for 24 weeks
11305773|NCT03100058|FG012|Participant Flow|Placebo qd (Epoch 4)|Placebo patients who entered Epoch 4 and received matching Placebo tablets qd
11305774|NCT03100058|OG000|Outcome|LIK066 2.5mg qd (Epoch 3)|LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
11305775|NCT03100058|OG001|Outcome|LIK066 10mg qd (Epoch 3)|LIK066 10mg qd (once daily) dosing frequency for 24 weeks
11305776|NCT03100058|OG002|Outcome|LIK066 50mg qd (Epoch 3)|LIK066 50mg qd (once daily) dosing frequency for 24 weeks
11305777|NCT03100058|OG003|Outcome|LIK066 150mg qd (Epoch 3)|LIK066 150mg qd (once daily) dosing frequency for 24 weeks
11305778|NCT03100058|OG004|Outcome|LIK066 2.5mg Bid (Epoch 3)|LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
11305779|NCT03100058|OG005|Outcome|LIK066 5mg Bid (Epoch 3)|LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
11305780|NCT03100058|OG006|Outcome|LIK066 25mg Bid (Epoch 3)|LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
11305781|NCT03100058|OG007|Outcome|LIK066 50mg Bid (Epoch 3)|LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
11305782|NCT03100058|OG008|Outcome|Placebo (Epoch 3)|Matching placebo tablets for 24 weeks
11305783|NCT03100058|OG009|Outcome|LIK066 qd/LIK066 25mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305784|NCT03100058|OG010|Outcome|LIK066 Bid/LIK066 35mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305785|NCT03100058|OG011|Outcome|Placebo/LIK066 25mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305786|NCT03100058|OG012|Outcome|Placebo/Placebo (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305787|NCT03100058|OG000|Outcome|LIK066 qd/LIK066 25mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305788|NCT03100058|OG001|Outcome|LIK066 Bid/LIK066 35mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305789|NCT03100058|OG002|Outcome|Placebo/LIK066 25mg qd (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305790|NCT03100058|OG003|Outcome|Placebo/Placebo (Epoch 4)|Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
11305791|NCT03100058|EG000|Reported Event|LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)|LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4)
11305792|NCT03100058|EG001|Reported Event|LIK066 10 mg qd/25 mg qd|LIK066 10mg qd (once daily) dosing frequency for 24 weeks
11305793|NCT03100058|EG002|Reported Event|LIK066 50 mg qd/25 mg qd|LIK066 50mg qd (once daily) dosing frequency for 24 weeks
11305794|NCT03100058|EG003|Reported Event|LIK066 150 mg qd/25 mg qd|LIK066 150mg qd (once daily) dosing frequency for 24 weeks
11305795|NCT03100058|EG004|Reported Event|LIK066 2.5 mg Bid/35 mg qd|LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
11305796|NCT03100058|EG005|Reported Event|LIK066 5 mg Bid/35 mg qd|LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
11305797|NCT03100058|EG006|Reported Event|LIK066 25 mg Bid/35 mg qd|LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
11305798|NCT03100058|EG007|Reported Event|LIK066 50 mg Bid/35 mg qd|LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
11305799|NCT03100058|EG008|Reported Event|Placebo/LIK066 25 mg qd (Epoch 4)|Matching placebo tablets for 24 weeks
11305800|NCT03100058|EG009|Reported Event|Placebo/Placebo|Matching placebo tablets
11305801|NCT03100123|BG000|Baseline|Standard of Care Arm|"Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.~Low-molecular-weight heparin: The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation."
10971977|NCT00918580|EG002|Reported Event|6-Month Follow-up|Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
10971978|NCT00918580|EG003|Reported Event|1-Year Follow-up|Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
10971979|NCT00918671|BG000|Baseline|Medication-overuse Headache|Chronic daily headache combined with medication overuse
10971980|NCT00918671|FG000|Participant Flow|Medication-overuse Headache|Chronic daily headache combined with medication overuse
11305802|NCT03100123|BG001|Baseline|Experimental Arm|"Open-label low-dose Aspirin 81 mg daily from randomization until delivery.~Aspirin 81 mg: Aspirin 81 mg po daily in tablet form."
11305803|NCT03100123|BG002|Baseline|Total|Total of all reporting groups
11305804|NCT03100123|FG000|Participant Flow|Standard of Care Arm|"Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.~Low-molecular-weight heparin: The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation."
11305805|NCT03100123|FG001|Participant Flow|Experimental Arm|"Open-label low-dose Aspirin 81 mg daily from randomization until delivery.~Aspirin 81 mg: Aspirin 81 mg po daily in tablet form."
11305806|NCT03100123|OG000|Outcome|Standard of Care Arm|"Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.~Low-molecular-weight heparin: The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation."
11305807|NCT03100123|OG001|Outcome|Experimental Arm|"Open-label low-dose Aspirin 81 mg daily from randomization until delivery.~Aspirin 81 mg: Aspirin 81 mg po daily in tablet form."
11305808|NCT03100123|OG000|Outcome|Approval Timeline|Sites requiring >18 months for all approvals
11305809|NCT03100123|OG000|Outcome|Screened Patients Who Met Eligibility Criteria|Screened patients who meet eligibility criteria
11305810|NCT03100123|OG000|Outcome|Consented Eligible Patients|Eligible patients who provided consent
11305811|NCT03100123|OG000|Outcome|Withdrawal/Lost to Follow-up|Withdrawal/Lost to follow-up among randomized patients
11305812|NCT03100123|OG000|Outcome|Crossover Rate|Crossover rate between standard of care and experimental study arms.
11305813|NCT03100123|EG000|Reported Event|Standard of Care Arm|"Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.~Low-molecular-weight heparin: The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation."
11305814|NCT03100123|EG001|Reported Event|Experimental Arm|"Open-label low-dose Aspirin 81 mg daily from randomization until delivery.~Aspirin 81 mg: Aspirin 81 mg po daily in tablet form."
10971981|NCT00918671|OG000|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
10971982|NCT00918671|EG000|Reported Event|Medication-overuse Headache|Chronic daily headache combined with medication overuse
10971983|NCT00918684|BG000|Baseline|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
11305815|NCT03100344|BG000|Baseline|Placebo|Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.
11305816|NCT03100344|BG001|Baseline|Nemolizumab (10 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 weeks treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.
11305817|NCT03100344|BG002|Baseline|Nemolizumab (30 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.
11305818|NCT03100344|BG003|Baseline|Nemolizumab (90 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.
11305819|NCT03100344|BG004|Baseline|Total|Total of all reporting groups
11305820|NCT03100344|FG000|Participant Flow|Placebo|Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroids (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305821|NCT03100344|FG001|Participant Flow|Nemolizumab (10 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305822|NCT03100344|FG002|Participant Flow|Nemolizumab (30 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305823|NCT03100344|FG003|Participant Flow|Nemolizumab (90 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305824|NCT03100344|OG000|Outcome|Placebo|Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe
11305825|NCT03100344|OG001|Outcome|Nemolizumab (10 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305826|NCT03100344|OG002|Outcome|Nemolizumab (30 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305827|NCT03100344|OG003|Outcome|Nemolizumab (90 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305828|NCT03100344|OG000|Outcome|Placebo|Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305829|NCT03100344|EG000|Reported Event|Placebo|Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305830|NCT03100344|EG001|Reported Event|Nemolizumab (10 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305831|NCT03100344|EG002|Reported Event|Nemolizumab (30 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305832|NCT03100344|EG003|Reported Event|Nemolizumab (90 mg)|Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
11305833|NCT03100500|BG000|Baseline|QMF-149 150/320 μg|QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler.
11305834|NCT03100500|FG000|Participant Flow|QMF-149 150/320 μg|QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler.
11305835|NCT03100500|OG000|Outcome|QMF-149 150/320 μg|QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler.
10971984|NCT00918684|FG000|Participant Flow|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
10971985|NCT00918684|OG000|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
11305836|NCT03100500|EG000|Reported Event|QMF149 150/320 µg|QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler.
11305837|NCT03100825|BG000|Baseline|QVM149|Participants received QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate) 150/50/160 mcg once daily as powder in hard capsules via Concept1 inhaler in the evening throughout treatment epoch of 52 weeks.
11305838|NCT03100825|FG000|Participant Flow|QVM149|Participants received QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate) 150/50/160 micrograms (mcg) once daily as powder in hard capsules via Concept1 inhaler in the evening throughout treatment epoch of 52 weeks.
11305839|NCT03100825|OG000|Outcome|QVM149|Participants received QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate) 150/50/160 mcg once daily as powder in hard capsules via Concept1 inhaler in the evening throughout treatment epoch of 52 weeks.
11305840|NCT03100825|EG000|Reported Event|QVM149|Participants received QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate) 150/50/160 μg once daily in the evening throughout treatment epoch of 52 weeks.
11305841|NCT03100838|BG000|Baseline|All Participants|Participants were randomized to one of the four sequences and were to receive all interventions.
11305842|NCT03100838|FG000|Participant Flow|Sequence 1 (ABCD)|"A Generic 1 x 60 mg Nifedipine extended-release tablet~B Brand (Procardia XL)~1 x 60 mg Nifedipine extended-release tablet~C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~D Brand (Procardia XL) +PPI (antacids)~1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~A washout period of at least 14 days occurs between each intervention.~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305843|NCT03100838|FG001|Participant Flow|Sequence 2 (BCDA)|"A Generic 1 x 60 mg Nifedipine extended-release tablet~B Brand (Procardia XL)~1 x 60 mg Nifedipine extended-release tablet~C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~D Brand (Procardia XL) +PPI (antacids)~1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~A washout period of at least 14 days occurs between each intervention.~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305844|NCT03100838|FG002|Participant Flow|Sequence 3 (CDAB)|"A Generic 1 x 60 mg Nifedipine extended-release tablet~B Brand (Procardia)~1 x 60 mg Nifedipine extended-release tablet~C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~D Brand (Procardia) +PPI (antacids)~1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~A washout period of at least 14 days occurs between each intervention.~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305845|NCT03100838|FG003|Participant Flow|Sequence 4 (DABC)|"A Generic 1 x 60 mg Nifedipine extended-release tablet~B Brand (Procardia XL)~1 x 60 mg Nifedipine extended-release tablet~C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~D Brand (Procardia XL) +PPI (antacids)~1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules~A washout period of at least 14 days occurs between each intervention.~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305846|NCT03100838|OG000|Outcome|Nifedipine (Generic)|"1 x 60 mg Nifedipine extended-release tablet~NIFEdipine 60 MG: Test Drug~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305847|NCT03100838|OG001|Outcome|Nifedipine (Brand)|"1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet~NIFEdipine 60 MG: Reference Drug~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305848|NCT03100838|OG002|Outcome|Nifedipine (Generic) + PPI|"1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7~NIFEdipine 60 MG: Test Drug~omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction"
11305849|NCT03100838|OG003|Outcome|Nifedipine (Brand) + PPI|"1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7~NIFEdipine 60 MG: Reference Drug~omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction"
11305850|NCT03100838|EG000|Reported Event|Nifedipine (Generic)|"1 x 60 mg Nifedipine extended-release tablet~NIFEdipine 60 MG: Test Drug~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305851|NCT03100838|EG001|Reported Event|Nifedipine (Brand)|"1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet~NIFEdipine 60 MG: Reference Drug~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305852|NCT03100838|EG002|Reported Event|Nifedipine (Generic) + PPI|"1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 8 days + 60 mg Nifedipine extended-release tablet on day 7~NIFEdipine 60 MG: Test Drug~omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305853|NCT03100838|EG003|Reported Event|Nifedipine (Brand) + PPI|"1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 8 days + 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7~NIFEdipine 60 MG: Reference Drug~omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction~SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology"
11305854|NCT03100864|BG000|Baseline|Spesolimab 1200 mg Intravenous (i.v.)|1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8).
11305855|NCT03100864|FG000|Participant Flow|Spesolimab 1200 mg Intravenous (i.v.)|1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8).
11305856|NCT03100864|OG000|Outcome|Spesolimab 1200 mg Intravenous (i.v.)|1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8).
11305857|NCT03100864|EG000|Reported Event|Spesolimab 1200 mg Intravenous (i.v.)|1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8).
11305858|NCT03100942|BG000|Baseline|Lanraplenib|Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
11305859|NCT03100942|BG001|Baseline|Filgotinib|Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks.
11305860|NCT03100942|BG002|Baseline|Tirabrutinib|Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.
11305861|NCT03100942|BG003|Baseline|Placebo|"Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:~lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)~filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)~tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)"
11305862|NCT03100942|BG004|Baseline|Total|Total of all reporting groups
11305863|NCT03100942|FG000|Participant Flow|Lanraplenib|Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
11305864|NCT03100942|FG001|Participant Flow|Filgotinib|Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks
11305865|NCT03100942|FG002|Participant Flow|Tirabrutinib|Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks
11305866|NCT03100942|FG003|Participant Flow|Placebo|"Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks.~At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:~filgotinib + lanraplenib placebo + tirabrutinib placebo~lanraplenib + filgotinib placebo + tirabrutinib placebo~tirabrutinib + filgotinib placebo + lanraplenib placebo"
11305867|NCT03100942|FG004|Participant Flow|Placebo to Lanraplenib|Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
11305868|NCT03100942|FG005|Participant Flow|Placebo to Filgotinib|Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
11305869|NCT03100942|FG006|Participant Flow|Placebo to Tirabrutinib|Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
11305870|NCT03100942|OG000|Outcome|Lanraplenib|Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
11305871|NCT03100942|OG001|Outcome|Filgotinib|Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
11305872|NCT03100942|OG002|Outcome|Tirabrutinib|Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
11305873|NCT03100942|OG003|Outcome|Placebo|"Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:~filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)~lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)~tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)"
11305874|NCT03100942|EG000|Reported Event|Lanraplenib|Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
11305875|NCT03100942|EG001|Reported Event|Filgotinib|Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks.
11305876|NCT03100942|EG002|Reported Event|Tirabrutinib|Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.
11305877|NCT03100942|EG003|Reported Event|Placebo to Lanraplenib|Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
11305878|NCT03100942|EG004|Reported Event|Placebo to Filgotinib|Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
11305879|NCT03100942|EG005|Reported Event|Placebo to Tirabrutinib|Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
11305880|NCT03100942|EG006|Reported Event|Placebo on Placebo Controlled Period|"Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks in placebo controlled period.~At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:~filgotinib + lanraplenib placebo + tirabrutinib placebo~lanraplenib + filgotinib placebo + tirabrutinib placebo~tirabrutinib + filgotinib placebo + lanraplenib placeboy once daily for 24 weeks."
11305881|NCT03100968|BG000|Baseline|Palpation Group|"The palpation group will have an epidural placed after manual palpation of the spine.~Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure"
11305882|NCT03100968|BG001|Baseline|Ultrasound Group|"The ultrasound group will have an epidural placed after identifying midline with the ultrasound.~Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure."
11305883|NCT03100968|BG002|Baseline|Total|Total of all reporting groups
11305884|NCT03100968|FG000|Participant Flow|Palpation Group|"The palpation group will have an epidural placed after manual palpation of the spine.~Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure"
11305885|NCT03100968|FG001|Participant Flow|Ultrasound Group|"The ultrasound group will have an epidural placed after identifying midline with the ultrasound.~Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure."
11305886|NCT03100968|OG000|Outcome|Palpation Group|"The palpation group will have an epidural placed after manual palpation of the spine.~Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure"
11305887|NCT03100968|OG001|Outcome|Ultrasound Group|"The ultrasound group will have an epidural placed after identifying midline with the ultrasound.~Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure."
11305888|NCT03100968|EG000|Reported Event|Palpation Group|"The palpation group will have an epidural placed after manual palpation of the spine.~Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure"
10971986|NCT00918684|EG000|Reported Event|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
11305889|NCT03100968|EG001|Reported Event|Ultrasound Group|"The ultrasound group will have an epidural placed after identifying midline with the ultrasound.~Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure."
11333022|NCT03506425|OG000|Outcome|All Completed Subjects - Groups 1 and 2|"Group 1: Standard care for 1 month, then standard care and Triheptanoin for 5 months.~Group 2: Standard care and Triheptanoin for 6 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333023|NCT03506425|OG000|Outcome|Group 1|"Standard care for 1 month, then standard care and Triheptanoin for 5 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333024|NCT03506425|OG001|Outcome|Group 2|"Standard care and Triheptanoin for 6 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333025|NCT03506425|OG002|Outcome|Group 3|Healthy controls for biomarkers
11333026|NCT03506425|EG000|Reported Event|Group 1|"Standard care for 1 month, then standard care and Triheptanoin for 5 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333027|NCT03506425|EG001|Reported Event|Group 2|"Standard care and Triheptanoin for 6 months.~Triheptanoin: Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease."
11333028|NCT03506425|EG002|Reported Event|Group 3|Healthy controls for biomarkers
11333029|NCT03506477|BG000|Baseline|Enstilar® Foam|Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
11333030|NCT03506477|BG001|Baseline|Vehicle Foam|Vehicle foam: for 4 weeks - does not contain the active ingredient
11333031|NCT03506477|BG002|Baseline|Total|Total of all reporting groups
11333032|NCT03506477|FG000|Participant Flow|Enstilar® Foam|Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
11333033|NCT03506477|FG001|Participant Flow|Vehicle Foam|Vehicle foam: for 4 weeks - does not contain the active ingredient
11333034|NCT03506477|OG000|Outcome|Enstilar® Foam|Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
11333035|NCT03506477|OG001|Outcome|Vehicle Foam|Vehicle foam: for 4 weeks - does not contain the active ingredient
11333036|NCT03506477|EG000|Reported Event|Enstilar® Foam|Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
11333037|NCT03506477|EG001|Reported Event|Vehicle Foam|Vehicle foam: for 4 weeks - does not contain the active ingredient
11333038|NCT03506724|BG000|Baseline|Intravenous Labetalol|"intravenous medication 20mg, 40mg, 80 mg~Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol."
11305890|NCT03101020|BG000|Baseline|Experimental Group|"The participants received standard care physiotherapy plus active visceral manipulation~Active Visceral Manipulation: Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodeno-jejunal valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes."
11305891|NCT03101020|BG001|Baseline|Control Group|"The participants received standard care physiotherapy plus placebo visceral manipulation~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.~Placebo Visceral Manipulation: The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique"
11305892|NCT03101020|BG002|Baseline|Total|Total of all reporting groups
11305893|NCT03101020|FG000|Participant Flow|Experimental Group|"10 participants received standard care physiotherapy plus active visceral manipulation~Active Visceral Manipulation: Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodeno-jejunal valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes."
11305894|NCT03101020|FG001|Participant Flow|Control Group|"10 participants received standard care physiotherapy plus placebo visceral manipulation~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.~Placebo Visceral Manipulation: The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique"
11305895|NCT03101020|OG000|Outcome|Experimental Group|"The participants received standard care physiotherapy plus active visceral manipulation~Active Visceral Manipulation: Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodeno-jejunal valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes."
11305896|NCT03101020|OG001|Outcome|Control Group|"The participants received standard care physiotherapy plus placebo visceral manipulation~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.~Placebo Visceral Manipulation: The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique"
11305897|NCT03101020|EG000|Reported Event|Experimental Group|"The participants received standard care physiotherapy plus active visceral manipulation~Active Visceral Manipulation: Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodeno-jejunal valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes."
11305898|NCT03101020|EG001|Reported Event|Control Group|"The participants received standard care physiotherapy plus placebo visceral manipulation~Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.~Placebo Visceral Manipulation: The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique"
11305899|NCT03101033|BG000|Baseline|Epidural Neuroplasty Group|"This group will be given epidural neuroplasty once enrolled.~Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.~Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.~Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection."
11305900|NCT03101033|BG001|Baseline|Transforaminal Steroid Injection Group|"This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.~Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected."
11305901|NCT03101033|BG002|Baseline|Total|Total of all reporting groups
11305902|NCT03101033|FG000|Participant Flow|Epidural Neuroplasty Group|"This group will be given epidural neuroplasty once enrolled.~Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.~Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.~Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection."
11305903|NCT03101033|FG001|Participant Flow|Transforaminal Steroid Injection Group|"This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.~Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected."
11305904|NCT03101033|OG000|Outcome|Epidural Neuroplasty Group|"This group will be given epidural neuroplasty once enrolled.~Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.~Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.~Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection."
11305905|NCT03101033|OG001|Outcome|Transforaminal Steroid Injection Group|"This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.~Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected."
11305906|NCT03101033|EG000|Reported Event|Transforaminal Steroid Injection Group|"This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.~Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected."
11305907|NCT03101033|EG001|Reported Event|Epidural Neuroplasty Group|"This group will be given epidural neuroplasty once enrolled.~Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.~Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.~Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection."
11305908|NCT03101111|BG000|Baseline|MV-CHIK-Placebo|2 MV-CHIK injections (day 0+day 28); 1 Placebo injection (day 0)
11305909|NCT03101111|BG001|Baseline|MMR-Placebo|2 Placebo injections (day 0+day 28); 1 MMR injection (day 0)
11305910|NCT03101111|BG002|Baseline|Total|Total of all reporting groups
11305911|NCT03101111|FG000|Participant Flow|MV-CHIK and Placebo|"Subjects will receive two injections on study day 0 and one injection on day 28.~On both days they will receive a 5E+05 (+/- 0.5 log) TCID50 intramuscularly in the deltoid muscle of one arm.~On day 0 they will receive a dummy injection of placebo (physiological saline) subcutaneously in the contralateral arm.~MV-CHIK: Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose"
11305912|NCT03101111|FG001|Participant Flow|MMR-vaccine and Placebo|"Subjects will receive two injections on study day 0 and one injection on day 28.~On both days they will receive dummy injections of placebo (physiological saline) in the deltoid muscle of one arm.~On day 0 they will receive MMR-vaccine subcutaneously in the contralateral arm.~MMR-vaccine: Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose"
11305913|NCT03101111|OG000|Outcome|MV-CHIK-Placebo/Seropositive|baseline seropositive cohort; received MV-CHIK-Placebo
11305914|NCT03101111|OG001|Outcome|MV-CHIK-Placebo/Seronegative|baseline seronegative cohort; received MV-CHIK-Placebo
10848472|NCT00289991|EG000|Reported Event|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
11305915|NCT03101111|OG002|Outcome|MMR-Placebo/Seropositive|baseline seropositive cohort; received MMR-Placebo
11305916|NCT03101111|OG003|Outcome|MMR-Placebo/Seronegative|baseline seronegative cohort; received MMR-Placebo
11305917|NCT03101111|EG000|Reported Event|MV-CHIK-Placebo/Seronegative|baseline seronegative cohort; received MV-CHIK-Placebo
11305918|NCT03101111|EG001|Reported Event|MV-CHIK-Placebo/Seropositive|baseline seropositive cohort; received MV-CHIK-Placebo
11305919|NCT03101111|EG002|Reported Event|MMR-Placebo/Seropositive|baseline seropositive cohort; received MMR-Placebo
11305920|NCT03101111|EG003|Reported Event|MMR-Placebo/Seronegative|baseline seronegative cohort; received MMR-Placebo
11305921|NCT03101150|BG000|Baseline|400 IU Vitamin D3|"400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.~400 IU Vitamin D3: Antenatal multivitamin"
11305922|NCT03101150|BG001|Baseline|4000 IU Vitamin D3|"4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.~4000 IU Vitamin D3: 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily"
10848473|NCT00289991|EG001|Reported Event|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
10848474|NCT00290147|BG000|Baseline|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848475|NCT00290147|BG001|Baseline|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848476|NCT00290147|BG002|Baseline|Total|Total of all reporting groups
10848477|NCT00290147|FG000|Participant Flow|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848478|NCT00290147|FG001|Participant Flow|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848479|NCT00290147|OG000|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848480|NCT00290147|OG001|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848481|NCT00290147|EG000|Reported Event|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848482|NCT00290147|EG001|Reported Event|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
10848483|NCT00290186|BG000|Baseline|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
10848484|NCT00290186|BG001|Baseline|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
10848485|NCT00290186|BG002|Baseline|Total|Total of all reporting groups
10848486|NCT00290186|FG000|Participant Flow|Hyperbaric Oxygen Treatment (HBO)|"Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~25 Were allocated to HBO 24 Completed all 40 treatments~1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing~Study terminated prior to 3-month followup testing~Did not return for 3- or 6-month followup testing~1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses"
10848487|NCT00290186|FG001|Participant Flow|Hyperbaric Air Treatment (HBA)|"Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~24 Were allocated to HBA 22 Completed all 40 treatments~1 Withdrew prior to treatments~1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing~1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing~1 Did not return for 6-month followup testing~1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses"
10848488|NCT00290186|OG000|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
11305923|NCT03101150|BG002|Baseline|Total|Total of all reporting groups
11305924|NCT03101150|FG000|Participant Flow|400 IU|Materna tablet once daily orally from 14 weeks of pregnancy til delivery.
11305925|NCT03101150|FG001|Participant Flow|4000 IU|Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
11305926|NCT03101150|OG000|Outcome|400 IU|Materna tablet once daily orally from 14 weeks of pregnancy til delivery.
11305927|NCT03101150|OG001|Outcome|4000 IU|Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
11305928|NCT03101150|EG000|Reported Event|400 IU|Materna tablet once daily orally from 14 weeks of pregnancy til delivery.
11305929|NCT03101150|EG001|Reported Event|4000 IU|Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
11305930|NCT03101241|BG000|Baseline|CX-8998|Participants were administered CX-8998 4 mg (2 capsules) BID in week 1, then 8 mg (4 capsules) BID in week 2, and then 10 mg (5 capsules) BID in weeks 3 and 4.
11305931|NCT03101241|BG001|Baseline|Placebo|Participants were administered a Placebo comparator of 2 capsules BID in week 1, then 4 capsules BID in week 2, and then 5 capsules BID in weeks 3 and 4.
11305932|NCT03101241|BG002|Baseline|Total|Total of all reporting groups
11305933|NCT03101241|FG000|Participant Flow|CX-8998|Participants were administered CX-8998 4 mg (2 capsules) BID in week 1, then 8 mg (4 capsules) BID in week 2, and then 10 mg (5 capsules) BID in weeks 3 and 4.
11305934|NCT03101241|FG001|Participant Flow|Placebo|Participants were administered a Placebo comparator of 2 capsules BID in week 1, then 4 capsules BID in Week 2, and then 5 capsules BID in Weeks 3 and 4.
11305935|NCT03101241|OG000|Outcome|CX-8998|Participants were administered CX-8998 4 mg (2 capsules) BID in week 1, then 8 mg (4 capsules) BID in week 2, and then 10 mg (5 capsules) BID in weeks 3 and 4.
11305936|NCT03101241|OG001|Outcome|Placebo|Participants were administered a Placebo comparator of 2 capsules BID in week 1, then 4 capsules BID in week 2, and then 5 capsules BID in weeks 3 and 4.
11305937|NCT03101241|EG000|Reported Event|CX-8998|Participants were administered CX-8998 4 mg (2 capsules) BID in week 1, then 8 mg (4 capsules) BID in week 2, and then 10 mg (5 capsules) BID in weeks 3 and 4.
11305938|NCT03101241|EG001|Reported Event|Placebo|Participants were administered a Placebo comparator of 2 capsules BID in week 1, then 4 capsules BID in week 2, and then 5 capsules BID in weeks 3 and 4.
11305939|NCT03101267|BG000|Baseline|ASP4070 4 mg|Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
11305940|NCT03101267|BG001|Baseline|ASP4070 1 mg|Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
11305941|NCT03101267|BG002|Baseline|Placebo|Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
11305942|NCT03101267|BG003|Baseline|Total|Total of all reporting groups
11305943|NCT03101267|FG000|Participant Flow|ASP4070 4 mg|Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
11305944|NCT03101267|FG001|Participant Flow|ASP4070 1 mg|Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
11305945|NCT03101267|FG002|Participant Flow|Placebo|Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
10848489|NCT00290186|OG001|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
10848490|NCT00290186|OG000|Outcome|Hyperbaric Oxygen Treatment (HBO)|"100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
11305946|NCT03101267|OG000|Outcome|ASP4070 4 mg|Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
11305947|NCT03101267|OG001|Outcome|ASP4070 1 mg|Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
11305948|NCT03101267|OG002|Outcome|Placebo|Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
11305949|NCT03101267|EG000|Reported Event|ASP4070 4 mg|Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.
11305950|NCT03101267|EG001|Reported Event|ASP4070 1 mg|Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.
11305951|NCT03101267|EG002|Reported Event|Placebo|Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.
11305952|NCT03101293|BG000|Baseline|TAK-831 400 mg Fasted + TAK-831 400 mg Fed|TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.
11305953|NCT03101293|BG001|Baseline|TAK-831 400 mg Fed + TAK-831 400 mg Fasted|TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.
11305954|NCT03101293|BG002|Baseline|Total|Total of all reporting groups
11305955|NCT03101293|FG000|Participant Flow|TAK-831 400 mg Fasted + TAK-831 400 mg Fed|TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.
11305956|NCT03101293|FG001|Participant Flow|TAK-831 400 mg Fed + TAK-831 400 mg Fasted|TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.
11305957|NCT03101293|OG000|Outcome|TAK-831 400 mg Fasted|TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.
11305958|NCT03101293|OG001|Outcome|TAK-831 400 mg Fed|TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
11305959|NCT03101293|EG000|Reported Event|TAK-831 400 mg Fasted|TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.
11305960|NCT03101293|EG001|Reported Event|TAK-831 400 mg Fed|TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
11305961|NCT03101358|BG000|Baseline|SOR007 0.15%|"0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305962|NCT03101358|BG001|Baseline|SOR007 1.0%|"1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305963|NCT03101358|BG002|Baseline|SOR007 2.0% Group A|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305964|NCT03101358|BG003|Baseline|SOR007 2.0% Group B|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305965|NCT03101358|BG004|Baseline|Total|Total of all reporting groups
11305966|NCT03101358|FG000|Participant Flow|SOR007 0.15%|"0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305967|NCT03101358|FG001|Participant Flow|SOR007 1.0%|"1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305968|NCT03101358|FG002|Participant Flow|SOR007 2.0% Group A|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305969|NCT03101358|FG003|Participant Flow|SOR007 2.0% Group B|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305970|NCT03101358|OG000|Outcome|SOR007 0.15%|"0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305971|NCT03101358|OG001|Outcome|SOR007 1.0%|"1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305972|NCT03101358|OG002|Outcome|SOR007 2.0% Group A|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305973|NCT03101358|OG003|Outcome|SOR007 2.0% Group B|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305974|NCT03101358|OG002|Outcome|SOR007 2.0%|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305975|NCT03101358|EG000|Reported Event|SOR007 0.15%|"0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305976|NCT03101358|EG001|Reported Event|SOR007 1.0%|"1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305977|NCT03101358|EG002|Reported Event|SOR007 2.0% Group A|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305978|NCT03101358|EG003|Reported Event|SOR007 2.0% Group B|"2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days~SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area."
11305979|NCT03101371|BG000|Baseline|Standard of Care Protocol Catheter Insertion|"Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.~Standard of care catheter insertion: Catheter inserted right out of package."
11305980|NCT03101371|BG001|Baseline|Aseptic Protocol for Catheter Insertion|"Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter~Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion."
11305981|NCT03101371|BG002|Baseline|Total|Total of all reporting groups
11305982|NCT03101371|FG000|Participant Flow|Standard of Care Protocol Catheter Insertion|"Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.~Standard of care catheter insertion: Catheter inserted right out of package."
11305983|NCT03101371|FG001|Participant Flow|Aseptic Protocol for Catheter Insertion|"Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter~Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion."
11305984|NCT03101371|OG000|Outcome|Standard of Care Protocol Catheter Insertion|"Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.~Standard of care catheter insertion: Catheter inserted right out of package."
11305985|NCT03101371|OG001|Outcome|Aseptic Protocol for Catheter Insertion|"Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter~Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion."
11305986|NCT03101371|EG000|Reported Event|Standard of Care Protocol Catheter Insertion|"Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.~Standard of care catheter insertion: Catheter inserted right out of package."
11305987|NCT03101371|EG001|Reported Event|Aseptic Protocol for Catheter Insertion|"Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter~Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion."
11305988|NCT03101462|BG000|Baseline|Inactivated Influenza Vaccine (IIV)|Eighteen subjects received one dose 0.5 mL of Inactivated Influenza Vaccine intramuscularly on Day 0.
11305989|NCT03101462|BG001|Baseline|Live Attenuated Influenza Vaccine (IIV)|Eighteen subjects received one dose 0.5 mL Live Attenuated Influenza Vaccine intranasally on Day 0.
11305990|NCT03101462|BG002|Baseline|Total|Total of all reporting groups
11305991|NCT03101462|FG000|Participant Flow|Group 1 Inactivated Influenza Vaccine (IIV)|Subjects aged 18-49 years received one dose of Inactivated Influenza Vaccine (IIV) intramuscularly.
11305992|NCT03101462|FG001|Participant Flow|Group 2 Live Attenuated Influenza Vaccine (LAIV)|Subjects 18-49 years of age received one dose of Live Attenuated Influenza Vaccine (LAIV) intranasally.
11305993|NCT03101462|OG000|Outcome|Inactivated Influenza Vaccine (IIV)|One 0.5 mL dose of IIV given intramuscularly.
11305994|NCT03101462|OG001|Outcome|Live Attenuated Influenza Vaccine (LAIV)|One 0.5 mL dose of LAIV given intranasally.
11305995|NCT03101462|EG000|Reported Event|Group 1 Licensed Trivalent FluMist|Subjects received one dose of Licensed Trivalent FluMist at Day 0.
11305996|NCT03101462|EG001|Reported Event|Group 1 Inactvated Trivalent Influenza Vaccine|Subjects received one dose of Inactivated Trivalent Influenza Vaccine at Day 0.
11305997|NCT03101514|BG000|Baseline|Kanglaite Group|Kanglaite injection was used during radiotherapy
11305998|NCT03101514|FG000|Participant Flow|Kanglaite Group|All patients received 20 g Kanglaite (200 mL) daily, administered as an intravenous injection for 5 days a week, concurrently with radiotherapy. Kanglaite injection was used before or after radiotherapy. There is no time interval requirement between Kanglaite and radiotherapy.
11305999|NCT03101514|OG000|Outcome|Kanglaite Group|Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
11306000|NCT03101514|EG000|Reported Event|Kanglaite Group|Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
11306001|NCT03101592|BG000|Baseline|Standard of Care ART Dispensing (SOC)|The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
11306002|NCT03101592|BG001|Baseline|Three-month ART Dispensing (3MD)|"Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study."
11306003|NCT03101592|BG002|Baseline|Six-month ART Dispensing (6MD)|"Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study."
11306004|NCT03101592|BG003|Baseline|Total|Total of all reporting groups
11306005|NCT03101592|FG000|Participant Flow|Standard of Care ART Dispensing|The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
11306006|NCT03101592|FG001|Participant Flow|Three-month ART Dispensing|"Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study."
11306007|NCT03101592|FG002|Participant Flow|Six-month ART Dispensing|"Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study."
11306008|NCT03101592|OG000|Outcome|Standard of Care ART Dispensing (SOC)|The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
11306009|NCT03101592|OG001|Outcome|Three-month ART Dispensing (3MD)|"Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study."
11333039|NCT03506724|BG001|Baseline|Oral Nifedipine|"Oral medication 10mg and 20mg~Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed."
11306010|NCT03101592|OG002|Outcome|Six-month ART Dispensing (6MD)|"Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study."
11306011|NCT03101592|OG000|Outcome|Malawi: Standard of Care (SOC)|Patients in the standard of care arm in Malawi.
11306012|NCT03101592|OG001|Outcome|Malawi: 3 Month Dispensing (3MD)|Patients in the 3 month dispensing arm in Malawi.
11306013|NCT03101592|OG002|Outcome|Malawi: 6 Month Dispensing (6MD)|Patients in the 6 month dispensing arm in Malawi.
11306014|NCT03101592|OG003|Outcome|Zambia: Standard of Care (SOC)|Patients in the standard of care arm in Zambia.
11306015|NCT03101592|OG004|Outcome|Zambia: 3 Month Dispensing (3MD)|Patients in the 3 month dispensing arm in Zambia.
11306016|NCT03101592|OG005|Outcome|Zambia: 6 Month Dispensing (6MD)|Patients in the 6 month dispensing arm in Zambia.
11306017|NCT03101592|EG000|Reported Event|Standard of Care ART Dispensing (SOC)|The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
11306018|NCT03101592|EG001|Reported Event|Three-month ART Dispensing (3MD)|"Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study."
11306019|NCT03101592|EG002|Reported Event|Six-month ART Dispensing (6MD)|"Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.~Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study."
11306020|NCT03102190|BG000|Baseline|Phase Ib|Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
11306021|NCT03102190|FG000|Participant Flow|Phase Ib|Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
11306022|NCT03102190|OG000|Outcome|Phase Ib|Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
11306023|NCT03102190|EG000|Reported Event|Phase Ib|Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
11306024|NCT03102411|BG000|Baseline|GI Symptoms Survey Population|The Survey participants are men and women between the ages of 18 and 80 in the United States
11306025|NCT03102411|FG000|Participant Flow|GI Symptoms Survey|The survey participants are men and women between the ages of 18 and 80 in the United States
11306026|NCT03102411|OG000|Outcome|GI Symptom Survey Population|The survey participants are men and women between the ages of 18 and 80 in the United States.
11306027|NCT03102411|OG000|Outcome|GI Symptoms Survey|The survey participants are men and women between the ages of 18 and 80 in the United States
11306028|NCT03102411|EG000|Reported Event|GI Symptoms Survey Population|The survey participants are men and women between the ages of 18 and 80 in the United States
11306029|NCT03102437|BG000|Baseline|Optimizer Smart System (3-Lead)|"All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306030|NCT03102437|BG001|Baseline|Optimizer Smart System (2-Lead)|"All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306031|NCT03102437|BG002|Baseline|Total|Total of all reporting groups
11306032|NCT03102437|FG000|Participant Flow|Optimizer Smart System (3-Lead)|"All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306033|NCT03102437|FG001|Participant Flow|Optimizer Smart System (2-Lead)|"All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306034|NCT03102437|OG000|Outcome|Optimizer Smart System (3-Lead)|"All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306035|NCT03102437|OG001|Outcome|Optimizer Smart System (2-Lead)|"All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11333040|NCT03506724|BG002|Baseline|Total|Total of all reporting groups
11306036|NCT03102437|EG000|Reported Event|Optimizer Smart System (3-Lead)|"All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306037|NCT03102437|EG001|Reported Event|Optimizer Smart System (2-Lead)|"All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).~Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day."
11306038|NCT03102645|BG000|Baseline|Imipramine First|"A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2~Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc~Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose"
11306039|NCT03102645|BG001|Baseline|Placebo First|"A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2~Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc~Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose"
11306040|NCT03102645|BG002|Baseline|Total|Total of all reporting groups
11306041|NCT03102645|FG000|Participant Flow|Imipramine First|"A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2~Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc~Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose"
11306042|NCT03102645|FG001|Participant Flow|Placebo First|"A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2~Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc~Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose"
11306043|NCT03102645|OG000|Outcome|Imipramine|Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose.
11306044|NCT03102645|OG001|Outcome|Placebo|Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
11306045|NCT03102645|OG001|Outcome|Placebo|Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc.
11306046|NCT03102645|EG000|Reported Event|Imipramine|Imipramine Hydrochloride 25 MG x2: Two Imipramin DAK film coated tablets 25 mg each, single dose
11306047|NCT03102645|EG001|Reported Event|Placebo|Placebo Oral Tablet x2: Two placebo film coated tablets containing lactose monohydrate, potato starch, gelatine, magnesium stearate, and talc
11306048|NCT03102710|BG000|Baseline|tDCS Enhancement|"In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306049|NCT03102710|BG001|Baseline|tDCS Inhibition|"In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306050|NCT03102710|BG002|Baseline|Sham tDCS|"Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia)."
11306051|NCT03102710|BG003|Baseline|Total|Total of all reporting groups
11306052|NCT03102710|FG000|Participant Flow|tDCS Enhancement|"In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306053|NCT03102710|FG001|Participant Flow|tDCS Inhibition|"In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306054|NCT03102710|FG002|Participant Flow|Sham tDCS|"Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia)."
11306055|NCT03102710|OG000|Outcome|tDCS Enhancement|"In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306056|NCT03102710|OG001|Outcome|tDCS Inhibition|"In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306057|NCT03102710|OG002|Outcome|Sham tDCS|"Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia)."
11306058|NCT03102710|EG000|Reported Event|tDCS Enhancement|"In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11333041|NCT03506724|FG000|Participant Flow|Oral Nifedipine|"Oral medication 10mg and 20mg~Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed."
11333042|NCT03506724|FG001|Participant Flow|Intravenous Labetalol|"Intravenous medication 20mg, 40mg, 80 mg~Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol."
10848491|NCT00290186|OG001|Outcome|Hyperbaric Air Treatment (HBA)|"14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
11306059|NCT03102710|EG001|Reported Event|tDCS Inhibition|"In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).~Control cream: A neutral cream will be applied on the arm as a control."
11306060|NCT03102710|EG002|Reported Event|Sham tDCS|"Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons.~transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.~Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).~Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia)."
11306061|NCT03102736|BG000|Baseline|Placebo and Ketamine|Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
11306062|NCT03102736|BG001|Baseline|Nitroprusside and Ketamine|0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
11306063|NCT03102736|BG002|Baseline|Total|Total of all reporting groups
11306064|NCT03102736|FG000|Participant Flow|Placebo and Ketamine|Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
11306065|NCT03102736|FG001|Participant Flow|Nitroprusside and Ketamine|0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
11306066|NCT03102736|OG000|Outcome|Placebo and Ketamine|Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
11306067|NCT03102736|OG001|Outcome|Nitroprusside and Ketamine|0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
11306068|NCT03102736|EG000|Reported Event|Placebo and Ketamine|Placebo saline given over 240 minutes + 0.5 mg/kg ketamine given over the last 40 minutes of the infusion
10848492|NCT00290186|EG000|Reported Event|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
11306069|NCT03102736|EG001|Reported Event|Nitroprusside and Ketamine|0.5 mcg/kg/min nitroprusside given over 240 min (4 hours) - 0.5 mg/kg ketamine given over the last 40 min of the nitroprusside infusion (starting at minute 200 the two drugs are given together)
11306070|NCT03102762|BG000|Baseline|BTX-A Group|"Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.~Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment."
11306071|NCT03102762|BG001|Baseline|Placebo Group|"Saline Group:~The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.~Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment."
11306072|NCT03102762|BG002|Baseline|Total|Total of all reporting groups
11306073|NCT03102762|FG000|Participant Flow|BTX-A Group|"Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.~Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment."
11306074|NCT03102762|FG001|Participant Flow|Placebo Group|"Saline Group:~The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.~Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment."
11306075|NCT03102762|OG000|Outcome|BTX-A Group|"Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.~Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment."
11306076|NCT03102762|OG001|Outcome|Placebo Group|"Saline Group:~The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.~Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment."
11306077|NCT03102762|OG000|Outcome|Botulinum Toxin Type A (BTX-A) Group|"Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.~Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment."
11306078|NCT03102762|EG000|Reported Event|BTX-A Group|"Experimental: BTX-A Group The treatment group, 80 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.~Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment."
11306079|NCT03102762|EG001|Reported Event|Placebo Group|"Saline Group:~The control group, 80 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.~Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment."
10848493|NCT00290186|EG001|Reported Event|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
11306080|NCT03102879|BG000|Baseline|Regenerative Procedure|Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306081|NCT03102879|BG001|Baseline|Endodontic Treatment|Conventional root canal treatment treatment with inert product gutapercha.
11306082|NCT03102879|BG002|Baseline|Total|Total of all reporting groups
11306083|NCT03102879|FG000|Participant Flow|Regenerative Procedure|Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306084|NCT03102879|FG001|Participant Flow|Endodontic Treatment|Conventional root canal treatment treatment with inert product gutapercha.
11306085|NCT03102879|OG000|Outcome|Regenerative Procedure|Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306086|NCT03102879|OG001|Outcome|Endodontic Treatment|Conventional root canal treatment treatment with inert product gutapercha.
11306087|NCT03102879|OG000|Outcome|Regenerative Procedure|Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306088|NCT03102879|OG001|Outcome|Conventional Treatment|Conventional Endodontic treatment
11306089|NCT03102879|OG000|Outcome|Regenerative Endodontic Procedure (REP)|umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306090|NCT03102879|OG001|Outcome|Conventional Root Canal Treatment|Conventional endodontic procedure
11306091|NCT03102879|EG000|Reported Event|Regenerative Procedure|Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
11306092|NCT03102879|EG001|Reported Event|Conventional Treatment|Conventional Endodontic treatment
11306093|NCT03102918|BG000|Baseline|Cannabidiol|"Epidiolex~Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period."
11306094|NCT03102918|BG001|Baseline|Placebo|"Placebo~Placebo: Participants will receive placebo over a 6-week treatment period."
11306095|NCT03102918|BG002|Baseline|Total|Total of all reporting groups
11306096|NCT03102918|FG000|Participant Flow|Cannabidiol|"Epidiolex~Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period."
11306097|NCT03102918|FG001|Participant Flow|Placebo|"Placebo~Placebo: Participants will receive placebo over a 6-week treatment period."
11306098|NCT03102918|OG000|Outcome|Cannabidiol|"Epidiolex~Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period."
11306099|NCT03102918|OG001|Outcome|Placebo|"Placebo~Placebo: Participants will receive placebo over a 6-week treatment period."
11306100|NCT03102918|EG000|Reported Event|Cannabidiol|"Epidiolex~Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period."
11306101|NCT03102918|EG001|Reported Event|Placebo|"Placebo~Placebo: Participants will receive placebo over a 6-week treatment period."
11306102|NCT03103061|BG000|Baseline|Standard Subject Enrollment|Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
11306103|NCT03103061|FG000|Participant Flow|Standard Subject Enrollment|Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
11306104|NCT03103061|OG000|Outcome|Standard Subject Enrollment|Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
11306105|NCT03103061|EG000|Reported Event|Standard Subject Enrollment|"This study will plan to include 100 adults who present to the MUSC ED, hospital, or outpatient clinic with a clinical history and symptoms suspicious for cardiac ischemia and who have undergone or will likely undergo nuclear stress testing (SPECT).~Patients who have been referred for a coronary CTA performed as part of a standard clinical evaluation determined by the treating physician(s) will be eligible for the study and recruited from the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist or primary physician will be contacted to ensure patient interest in the study and willingness to be approached. Willing patients will be approached and will undergo the informed consent process."
11306106|NCT03103100|BG000|Baseline|1% Lidocaine|"Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine~1% Lidocaine: 10 mL of 1% lidocaine"
11306107|NCT03103100|BG001|Baseline|0.25% Bupivacaine|"Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine~0.25% Bupivacaine: 10 mL of 0.25% bupivacaine"
11306108|NCT03103100|BG002|Baseline|Bupivacaine Plus Lidocaine|"Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.~Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine"
11306109|NCT03103100|BG003|Baseline|Total|Total of all reporting groups
11306110|NCT03103100|FG000|Participant Flow|1% Lidocaine|"Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine~1% Lidocaine: 10 mL of 1% lidocaine"
11306111|NCT03103100|FG001|Participant Flow|0.25% Bupivacaine|"Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine~0.25% Bupivacaine: 10 mL of 0.25% bupivacaine"
11306112|NCT03103100|FG002|Participant Flow|Bupivacaine Plus Lidocaine|"Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.~Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine"
11306113|NCT03103100|OG000|Outcome|1% Lidocaine|"Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine~1% Lidocaine: 10 mL of 1% lidocaine"
11306114|NCT03103100|OG001|Outcome|0.25% Bupivacaine|"Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine~0.25% Bupivacaine: 10 mL of 0.25% bupivacaine"
11306115|NCT03103100|OG002|Outcome|Bupivacaine Plus Lidocaine|"Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.~Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine"
11306116|NCT03103100|EG000|Reported Event|1% Lidocaine|"Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine~1% Lidocaine: 10 mL of 1% lidocaine"
11306117|NCT03103100|EG001|Reported Event|0.25% Bupivacaine|"Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine~0.25% Bupivacaine: 10 mL of 0.25% bupivacaine"
11306118|NCT03103100|EG002|Reported Event|Bupivacaine Plus Lidocaine|"Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.~Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine"
11306119|NCT03103282|BG000|Baseline|PuraStat®|Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
11306120|NCT03103282|FG000|Participant Flow|PuraStat®|Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
11306121|NCT03103282|OG000|Outcome|PuraStat®|Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
11306122|NCT03103282|EG000|Reported Event|PuraStat®|Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
11306123|NCT03103438|BG000|Baseline|Cohort 1|One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
11306124|NCT03103438|BG001|Baseline|Cohort 2|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
11306125|NCT03103438|BG002|Baseline|Cohort 3|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
11306126|NCT03103438|BG003|Baseline|Cohort 4|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
11306127|NCT03103438|BG004|Baseline|Cohort 5|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
11306128|NCT03103438|BG005|Baseline|Cohort 6|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
11306129|NCT03103438|BG006|Baseline|Cohort 7|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
11306130|NCT03103438|BG007|Baseline|Total|Total of all reporting groups
11306131|NCT03103438|FG000|Participant Flow|Cohort 1|One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
11306132|NCT03103438|FG001|Participant Flow|Cohort 2|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
11306133|NCT03103438|FG002|Participant Flow|Cohort 3|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
11306134|NCT03103438|FG003|Participant Flow|Cohort 4|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
11306135|NCT03103438|FG004|Participant Flow|Cohort 5|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
11306136|NCT03103438|FG005|Participant Flow|Cohort 6|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
11306137|NCT03103438|FG006|Participant Flow|Cohort 7|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
11306138|NCT03103438|OG000|Outcome|Cohort 1|One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
11306139|NCT03103438|OG001|Outcome|Cohort 2|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
11306140|NCT03103438|OG002|Outcome|Cohort 3|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
11306141|NCT03103438|OG003|Outcome|Cohort 4|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
11306142|NCT03103438|OG004|Outcome|Cohort 5|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
11306143|NCT03103438|OG005|Outcome|Cohort 6|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
11306144|NCT03103438|OG006|Outcome|Cohort 7|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
11306145|NCT03103438|EG000|Reported Event|Cohort 1|One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
11306146|NCT03103438|EG001|Reported Event|Cohort 2|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
11306147|NCT03103438|EG002|Reported Event|Cohort 3|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
11306148|NCT03103438|EG003|Reported Event|Cohort 4|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
11306149|NCT03103438|EG004|Reported Event|Cohort 5|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
11306150|NCT03103438|EG005|Reported Event|Cohort 6|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
11306151|NCT03103438|EG006|Reported Event|Cohort 7|Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
11306152|NCT03103503|BG000|Baseline|BIOTRONIK Plexa ICD Lead|Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
11306153|NCT03103503|FG000|Participant Flow|BIOTRONIK Plexa ICD Lead|Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
11306154|NCT03103503|OG000|Outcome|BIOTRONIK Plexa ICD Lead|Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
11306155|NCT03103503|EG000|Reported Event|BIOTRONIK Plexa ICD Lead|Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
11306156|NCT03103763|BG000|Baseline|Aged 90 and Older|"Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306157|NCT03103763|BG001|Baseline|Aged 80-89|"Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306158|NCT03103763|BG002|Baseline|Aged 70-79|"Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306159|NCT03103763|BG003|Baseline|Total|Total of all reporting groups
11306160|NCT03103763|FG000|Participant Flow|Aged 90 and Older|"Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306161|NCT03103763|FG001|Participant Flow|Aged 80-89|"Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306162|NCT03103763|FG002|Participant Flow|Aged 70-79|"Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306163|NCT03103763|OG000|Outcome|Aged 90 and Older|"Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306164|NCT03103763|OG001|Outcome|Aged 80-89|"Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306165|NCT03103763|OG002|Outcome|Aged 70-79|"Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306166|NCT03103763|EG000|Reported Event|Aged 90 and Older|"Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306167|NCT03103763|EG001|Reported Event|Aged 80-89|"Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306168|NCT03103763|EG002|Reported Event|Aged 70-79|"Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.~Warfarin: Patients on warfarin for atrial fibrillation"
11306169|NCT03103906|BG000|Baseline|Group 1 (Test Product)|Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11306170|NCT03103906|BG001|Baseline|Group 2 (No Test Product)|Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
11306171|NCT03103906|BG002|Baseline|Total|Total of all reporting groups
11306172|NCT03103906|FG000|Participant Flow|Group 1 (Test Product)|Participants were instructed to apply test product (approximately 0.6-1 g[gram]) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11306173|NCT03103906|FG001|Participant Flow|Group 2 (No Test Product)|Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
11306174|NCT03103906|OG000|Outcome|Group 1 (Test Product)|Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11306175|NCT03103906|OG001|Outcome|Group 2 (No Test Product)|Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
11306176|NCT03103906|EG000|Reported Event|Group 1 (Test Product)|Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11306177|NCT03103906|EG001|Reported Event|Group 2 (No Test Product)|Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days.
11306178|NCT03103919|BG000|Baseline|Rotigotine + Standard Care|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice.
11306179|NCT03103919|BG001|Baseline|Rotigotine + Standard Care + Kinesia-360™ Wearable Device|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.
11306180|NCT03103919|BG002|Baseline|Total Title|
11306181|NCT03103919|FG000|Participant Flow|Rotigotine + Standard Care|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice.
11306182|NCT03103919|FG001|Participant Flow|Rotigotine + Standard Care + Kinesia-360™ Wearable Device|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.
11306183|NCT03103919|OG000|Outcome|Rotigotine + Standard Care FAS|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice.
11306184|NCT03103919|OG001|Outcome|Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.
11306185|NCT03103919|OG000|Outcome|Rotigotine + Standard Care SS|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice.
11306186|NCT03103919|OG001|Outcome|Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.
11306187|NCT03103919|EG000|Reported Event|Rotigotine + Standard Care|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice.
11306188|NCT03103919|EG001|Reported Event|Rotigotine + Standard Care + Kinesia-360™ Wearable Device|Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.
11306189|NCT03104192|BG000|Baseline|Develop & Refine MOWI w/o Amulet (2A)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.~Develop & Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks."
11306190|NCT03104192|BG001|Baseline|MOWI Weight Loss Maintenance|"Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.~MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification)."
11306191|NCT03104192|BG002|Baseline|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306192|NCT03104192|BG003|Baseline|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306193|NCT03104192|BG004|Baseline|Total|Total of all reporting groups
11306194|NCT03104192|FG000|Participant Flow|Develop & Refine MOWI w/o Amulet (2A)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.~Develop & Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks."
11306195|NCT03104192|FG001|Participant Flow|MOWI Weight Loss Maintenance|"Evaluate the feasibility, acceptability, + potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.~MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 min. The overall structure will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment.~Participants in MOWI Weight Loss Maintenance were separately enrolled in this Study and did not enter the Maintenance from one or more remaining arms included here."
11306196|NCT03104192|FG002|Participant Flow|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306197|NCT03104192|FG003|Participant Flow|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306198|NCT03104192|OG000|Outcome|Develop & Refine MOWI w/o Amulet (2A)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.~Develop & Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks."
11306199|NCT03104192|OG001|Outcome|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306200|NCT03104192|OG002|Outcome|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306201|NCT03104192|OG001|Outcome|MOWI Weight Loss Maintenance|"Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.~MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification)."
10848494|NCT00290199|BG000|Baseline|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
10848495|NCT00290199|BG001|Baseline|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
10848496|NCT00290199|BG002|Baseline|Total|Total of all reporting groups
11306202|NCT03104192|OG002|Outcome|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306203|NCT03104192|OG003|Outcome|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306204|NCT03104192|OG000|Outcome|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306205|NCT03104192|OG001|Outcome|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306206|NCT03104192|OG000|Outcome|MOWI Weight Loss Maintenance|"Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.~MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification)."
11306207|NCT03104192|OG000|Outcome|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306208|NCT03104192|EG000|Reported Event|Develop & Refine MOWI w/o Amulet (2A)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.~Develop & Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks."
11306209|NCT03104192|EG001|Reported Event|MOWI Weight Loss Maintenance|"Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.~MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification)."
11306210|NCT03104192|EG002|Reported Event|Develop & Refine MOWI w Fitbit (2B)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.~Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance."
11306211|NCT03104192|EG003|Reported Event|Develop & Refine MOWI w Fitbit/Protein (2P)|"Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.~Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions."
11306212|NCT03104322|BG000|Baseline|Observation Sequence|"Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks~patientMpower platform: electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms~usual care: usual care"
11306213|NCT03104322|FG000|Participant Flow|Observation Sequence|"Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks~patientMpower platform: electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms~usual care: usual care"
11306214|NCT03104322|OG000|Outcome|Observation Sequence|"Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks~patientMpower platform: electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms~usual care: usual care"
11306215|NCT03104322|EG000|Reported Event|Observation Sequence|"Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks~patientMpower platform: electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms~usual care: usual care"
11306216|NCT03104647|BG000|Baseline|VRP-Clinic|"VRP-Clinic software on a virtual reality platform~VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment"
11306217|NCT03104647|FG000|Participant Flow|VRP-Clinic|"VRP-Clinic software on a virtual reality platform~VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment"
11306218|NCT03104647|OG000|Outcome|VRP-Clinic|"VRP-Clinic software on a virtual reality platform~VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment"
11306219|NCT03104647|EG000|Reported Event|VRP-Clinic|"VRP-Clinic software on a virtual reality platform~VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment"
11306220|NCT03104725|BG000|Baseline|Healthy Volunteers|HV participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed within 48 hours of LP 1. No NAC treatment is administered.
11306221|NCT03104725|BG001|Baseline|Parkinson's Disease (PD) Patients|PD participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4- dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed after the patient has taken at least 5 doses of N-Acetylcysteine (NAC) (2 grams orally twice per day).
11306222|NCT03104725|BG002|Baseline|Total|Total of all reporting groups
11306223|NCT03104725|FG000|Participant Flow|Healthy Volunteers (HVs)|HV participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed within 48 hours of LP 1. No NAC treatment is administered.
11306224|NCT03104725|FG001|Participant Flow|Parkinson's Disease (PD) Patients|PD participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4- dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed after the patient has taken at least 5 doses of N-Acetylcysteine (NAC) (2 grams orally twice per day).
11306225|NCT03104725|OG000|Outcome|Healthy Volunteers (HVs)|HV participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed within 48 hours of LP 1. No NAC treatment is administered.
11306226|NCT03104725|OG001|Outcome|Parkinson's Disease (PD) Patients|PD participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4- dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed after the patient has taken at least 5 doses of N-Acetylcysteine (NAC) (2 grams orally twice per day).
11306227|NCT03104725|EG000|Reported Event|Healthy Volunteers (HVs)|HV participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed within 48 hours of LP 1. No NAC treatment is administered.
11306228|NCT03104725|EG001|Reported Event|Parkinson's Disease (PD) Patients|PD participants undergo a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4- dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed after the patient has taken at least 5 doses of N-Acetylcysteine (NAC) (2 grams orally twice per day).
11306229|NCT03104738|BG000|Baseline|50% Reduction of Basal Insulin Dose|This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
11306230|NCT03104738|BG001|Baseline|25% Reduction of Basal Insulin Dose|"The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.~25% reduction of basal insulin dose: Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.~Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital."
11306231|NCT03104738|BG002|Baseline|Total|Total of all reporting groups
11306232|NCT03104738|FG000|Participant Flow|50% Reduction of Basal Insulin Dose|This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
11306233|NCT03104738|FG001|Participant Flow|25% Reduction of Basal Insulin Dose|"The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.~25% reduction of basal insulin dose: Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.~Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital."
11306234|NCT03104738|OG000|Outcome|50% Reduction of Basal Insulin Dose|This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
11306235|NCT03104738|OG001|Outcome|25% Reduction of Basal Insulin Dose|"The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.~25% reduction of basal insulin dose: Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.~Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital."
11306236|NCT03104738|EG000|Reported Event|50% Reduction of Basal Insulin Dose|This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
11306237|NCT03104738|EG001|Reported Event|25% Reduction of Basal Insulin Dose|"The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.~25% reduction of basal insulin dose: Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.~Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital."
11306238|NCT03104816|BG000|Baseline|Acetaminophen IV Soln 10 MG/ML (A)|"Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen IV Soln 10 MG/ML~Hydromorphone"
11306239|NCT03104816|BG001|Baseline|PO Acetaminophen (B)|"Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen~Hydromorphone"
11306240|NCT03104816|BG002|Baseline|Hydromorphone (Control Arm) (C)|"Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.~Hydromorphone"
11306241|NCT03104816|BG003|Baseline|Total|Total of all reporting groups
10848497|NCT00290199|FG000|Participant Flow|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
11306242|NCT03104816|FG000|Participant Flow|Acetaminophen IV Soln 10 Milligram/Milliliter (MG/ML) (A)|"Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen IV Soln MG/ML~Hydromorphone"
11306243|NCT03104816|FG001|Participant Flow|PO Acetaminophen (B)|"Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen~Hydromorphone"
10848498|NCT00290199|FG001|Participant Flow|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
11306244|NCT03104816|FG002|Participant Flow|Hydromorphone (Control Arm) (C)|"Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.~Hydromorphone"
11306245|NCT03104816|OG000|Outcome|Acetaminophen IV Soln 10 MG/ML (A)|Hydromorphone and IV Acetaminophen are given to this group
11306246|NCT03104816|OG001|Outcome|PO Acetaminophen (B)|Hydromorphone and PO acetaminophen are given to this group
11306247|NCT03104816|OG002|Outcome|Hydromorphone (Control Arm) (C)|Hydromorphone only is given to the patients in this group
11306248|NCT03104816|EG000|Reported Event|Acetaminophen IV Soln 10 MG/ML (A)|"Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen IV Soln 10 MG/ML~Hydromorphone~No adverse events."
11306249|NCT03104816|EG001|Reported Event|PO Acetaminophen (B)|"Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.~Acetaminophen~Hydromorphone~No adverse events."
11306250|NCT03104816|EG002|Reported Event|Hydromorphone (Control Arm) (C)|"Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.~Hydromorphone~No adverse events."
11306251|NCT03104985|BG000|Baseline|Conventional Treatment|Conventional treatment only.
11306252|NCT03104985|BG001|Baseline|Conventional Therapy and Combined LLLT|Conventional therapy and combined LLLT (LASMIK device)
11306253|NCT03104985|BG002|Baseline|Total|Total of all reporting groups
11306254|NCT03104985|FG000|Participant Flow|Conventional Treatment|"An elastic compression of lower extremities: elastic bandages or compression hosiery of class 2~Pharmacotherapy: Anavenol, Aescusan, Glyvenol; drugs of the Benzopyrone group, including Troxevasin and Venoruton. Trental, Aspirin and Ticlid (Ticlopidine). Nonsteroidal anti-inflammatory drugs (Nimesil, OKI), various ointments containing Heparin, corticosteroids, as well as nonsteroidal anti-inflammatory drugs. Antibiotic therapy.~Topical treatment: in the presence of purulent discharge (phase I of the wound healing process) - bandaging with antiseptic solutions (1% Iodopiron solution, 0.1% Chlorhexidine solution) and hydrophilic ointments (Levosin, Levomecol). In phases II and III - after ulcer cleansing the preparations based on Hyaluronic acid (Curiozin).~Conventional therapy: - An elastic compression of lower extremities,~Pharmacotherapy,~Topical treatment"
11306255|NCT03104985|FG001|Participant Flow|Conventional Therapy and Combined LLLT|"External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme:~- 365-405nm, power 1-2mW, exposure 2 min;~- 520-525nm, 1-2mW, 5 min;~- 365-405nm, 1-2mW, 2 min;~- 520-525nm, 1-2mW, 5 min;~- 365-405nm, 1-2mW, 2 min;~- 520-525nm, 1-2mW, 5 min;~- 365-405nm, 1-2mW, 2 min;~- 520-525nm, 1-2mW, 5 min;~- 365-405nm, 1-2mW, 2 min;~- 520-525nm, 1-2mW, 5 min;~- 365-405nm, 1-2mW, 2 min;~- 520-525nm, 1-2mW, 5 min"
11306256|NCT03104985|OG000|Outcome|Conventional Treatment|Conventional treatment only.
11306257|NCT03104985|OG001|Outcome|Conventional Therapy and Combined LLLT|Conventional therapy and combined LLLT (LASMIK device).
11306258|NCT03104985|EG000|Reported Event|Conventional Treatment|Conventional treatment only.
11306259|NCT03104985|EG001|Reported Event|Conventional Therapy and Combined LLLT|Conventional therapy and combined LLLT (LASMIK device).
11333043|NCT03506724|OG000|Outcome|Intravenous Labetalol|"intravenous medication 20mg, 40mg, 80 mg~Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol."
11333044|NCT03506724|OG001|Outcome|Oral Nifedipine|"Oral medication 10mg and 20mg~Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed."
11333045|NCT03506724|EG000|Reported Event|Intravenous Labetalol|"intravenous medication 20mg, 40mg, 80 mg~Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol."
11333046|NCT03506724|EG001|Reported Event|Oral Nifedipine|"Oral medication 10mg and 20mg~Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed."
11333047|NCT03507036|BG000|Baseline|Treatment|"All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.~Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression."
11333048|NCT03507036|FG000|Participant Flow|Treatment|"All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.~Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression."
11333049|NCT03507036|OG000|Outcome|Treatment|"All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.~Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression."
11306260|NCT03105297|BG000|Baseline|All Participants|All participants to whom the study treatment was dispensed were considered evaluable for baseline characteristics
11306261|NCT03105297|FG000|Participant Flow|All Participants|The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule
11306262|NCT03105297|OG000|Outcome|All Participants (Nasal Resistance Phase)|The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
11306263|NCT03105297|OG000|Outcome|All Participants (Baseline Phase)|All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1
11306264|NCT03105297|OG000|Outcome|All Participants (Active Phase)|All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment
11306265|NCT03105297|OG000|Outcome|All Participants|The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule
11306266|NCT03105297|OG000|Outcome|All Participants|This was a baseline-controlled study and consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants were applied nasal dilator strip during the sleep laboratory night on Day 1 (Night 1). During the active phase all the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8, Night 8) and 28 days (Day 29, Night 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 Night 30 and Day 31 Night 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' as per the randomization schedule
11306267|NCT03105297|EG000|Reported Event|All Participants (Baseline Phase)|All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1
11306268|NCT03105297|EG001|Reported Event|All Participants (Active Phase)|All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment
11306269|NCT03105297|EG002|Reported Event|Participants With Strip (Nasal Resisatnce Phase)|The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who applied the strip.
11306270|NCT03105297|EG003|Reported Event|Participants Without Strip (Nasal Resisatnce Phase)|The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who did not applied the strip.
11306271|NCT03105362|BG000|Baseline|AA ORS Arm|"Patients will consume commercially amino acid based oral rehydration solution (enterade®).~Enterade® oral rehydration solution: Commercially available amino acid based oral rehydration solution"
11306272|NCT03105362|FG000|Participant Flow|AA ORS Arm|Patients consumed (orally) an amino acid (AA) based oral rehydration solution (ORS) (enterade®) for 2 weeks as part of their baseline enteral hydration needs.
11306273|NCT03105362|OG000|Outcome|Primary Outcome|AA ORS arm-Stool Output in subjects w/ ostomy
11306274|NCT03105362|OG000|Outcome|Outcome Measure (2)|AA ORS arm-Emesis and/or abdominal distension
11306275|NCT03105362|OG000|Outcome|Outcome Measure (3)|AA ORS arm-Palatability Rating
11306276|NCT03105362|OG000|Outcome|Primary Outcome|AA ORS arm-Stool output for subjects in continuity
11306277|NCT03105362|EG000|Reported Event|AA ORS Arm|Participants consuming enterade (amino acid-oral rehydration solution)
11306278|NCT03105479|BG000|Baseline|Part A / Cohort A|Subjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
11306279|NCT03105479|FG000|Participant Flow|Part A / Cohort A|Subjects from 12 years to 18 years old (exclusive) are to be treated with cadazolid 250 mg twice daily for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
11306280|NCT03105479|FG001|Participant Flow|Part A / Cohort B|Subjects from 6 years to 12 years old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC)).
11306281|NCT03105479|FG002|Participant Flow|Part A / Cohort C|Subjects from 2 years to 6 years old (exclusive) are to be treated with cadazolid for 10 days. (dose determined based on the PK and safety data from cohort B reviewed by the IDMC).
11306282|NCT03105479|FG003|Participant Flow|Part A/ Cohort D|Subjects from 3 months to 2 years old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort B reviewed by the IDMC).
11306283|NCT03105479|FG004|Participant Flow|Part A/ Cohort E|Subjects from birth to 3 months old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort B reviewed by the IDMC). .
10848499|NCT00290199|OG000|Outcome|Transcervical Foley|Insertion of a a transcervical foley catheter to induce labor
11306284|NCT03105479|FG005|Participant Flow|Part B / Cadazolid|Subjects from birth to 18 years old (exclusive) are to be treated with cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A.
11306285|NCT03105479|FG006|Participant Flow|Part B / Vancomycin|Subjects from birth to 18 years old (exclusive)are to be treated with vancomycin for 10 days either as capsules (for subjects able to swallow) or oral solution (for the others) .
11306286|NCT03105479|OG000|Outcome|Part B|Due to early termination of the study, no subject was enrolled into Part B.
11306287|NCT03105479|OG000|Outcome|Part A / Cohort A|One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
11306288|NCT03105479|OG000|Outcome|Part A / Cohorts A to E|Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
11306289|NCT03105479|OG001|Outcome|Part B / Cadazolid|No subject was enrolled in cohort B due to early study termination.
11306290|NCT03105479|EG000|Reported Event|Overall Study (Part A and Part B)|Only one subject was included in cohort A; no subject was enrolled in the other cohorts of Part A or Part B due to early study termination.
11306291|NCT03105518|BG000|Baseline|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
11306292|NCT03105518|FG000|Participant Flow|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
11306293|NCT03105518|OG000|Outcome|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen"
11306294|NCT03105518|EG000|Reported Event|Analgesia Options|"Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.~Fentanyl: 0.5, 1 mcg/kg~Acetaminophen: Single + Oxycodone~Oxycodone: With Acetaminophen~No Adverse Events in any subject"
11306295|NCT03106077|BG000|Baseline|Cohort A: Advanced Triple-Negative Breast Cancer(TNBC)|6 mg/kg IMGN853 IV Q3W
11306296|NCT03106077|FG000|Participant Flow|Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)|6 mg/kg IMGN853 IV Q3W
11306297|NCT03106077|FG001|Participant Flow|Cohort B: Localized Breast Cancer|6 mg/kg IMGN853 IV Q3W for 4 cycles
11306298|NCT03106077|OG000|Outcome|Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)|6 mg/kg IMGN853 IV Q3W
11306299|NCT03106077|OG000|Outcome|Cohort B: Localized Breast Cancer|6 mg/kg IMGN853 IV Q3W for 4 cycles
11306300|NCT03106077|EG000|Reported Event|Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)|6 mg/kg IMGN853 IV Q3W
11306301|NCT03106337|BG000|Baseline|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
11306302|NCT03106337|FG000|Participant Flow|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
11306303|NCT03106337|OG000|Outcome|Shear-Wave Elastography, Benign Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.
11306304|NCT03106337|OG001|Outcome|Shear-Wave Elastography, Malignant Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
11306305|NCT03106337|EG000|Reported Event|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
11306306|NCT03106636|BG000|Baseline|KEEP-P|The KEEP-P caregiver support groups employ a manualized 12-session, weekly curriculum for foster, kinship, and biological caregivers. Each weekly 2 hour session is structured so that the curriculum content is integrated into group discussions, and primary concepts are illustrated via role-play. Home practice assignments are given weekly and relate to the topics covered during sessions to assist parents in implementing the behavioral procedures taught.
11306307|NCT03106636|BG001|Baseline|KEEP-P+|The KEEP-P+ group received the same 12-session, weekly curriculum as the KEEP-P group, and also received an additional video coaching component. The video coaching employs video of caregivers' natural interactions with their child to show ways that they are supporting children's healthy development. It is a simple and practical approach that emphasizes caregivers' strengths and capabilities. It begins with video recordings of a caregiver and child in their home or other natural setting. The film is carefully edited to show brief clips in which the caregiver is engaged in developmentally supportive interactions with the child. At a group coaching session, a coach reviews the edited clips in detail with the caregivers.
11306308|NCT03106636|BG002|Baseline|Total|Total of all reporting groups
11306309|NCT03106636|FG000|Participant Flow|KEEP-P|The KEEP-P caregiver support groups employ a manualized 12-session, weekly curriculum for foster, kinship, and biological caregivers. Each weekly 2 hour session is structured so that the curriculum content is integrated into group discussions, and primary concepts are illustrated via role-play. Home practice assignments are given weekly and relate to the topics covered during sessions to assist parents in implementing the behavioral procedures taught.
11306310|NCT03106636|FG001|Participant Flow|KEEP-P+|The KEEP-P+ group received the same 12-session, weekly curriculum as the KEEP-P group, and also received an additional video coaching component. The video coaching employs video of caregivers' natural interactions with their child to show ways that they are supporting children's healthy development. It is a simple and practical approach that emphasizes caregivers' strengths and capabilities. It begins with video recordings of a caregiver and child in their home or other natural setting. The film is carefully edited to show brief clips in which the caregiver is engaged in developmentally supportive interactions with the child. At a group coaching session, a coach reviews the edited clips in detail with the caregivers.
11306311|NCT03106636|OG000|Outcome|KEEP-P|The KEEP-P caregiver support groups employ a manualized 12-session, weekly curriculum for foster, kinship, and biological caregivers. Each weekly 2 hour session is structured so that the curriculum content is integrated into group discussions, and primary concepts are illustrated via role-play. Home practice assignments are given weekly and relate to the topics covered during sessions to assist parents in implementing the behavioral procedures taught.
11306312|NCT03106636|OG001|Outcome|KEEP-P+|The KEEP-P+ group received the same 12-session, weekly curriculum as the KEEP-P group, and also received an additional video coaching component. The video coaching employs video of caregivers' natural interactions with their child to show ways that they are supporting children's healthy development. It is a simple and practical approach that emphasizes caregivers' strengths and capabilities. It begins with video recordings of a caregiver and child in their home or other natural setting. The film is carefully edited to show brief clips in which the caregiver is engaged in developmentally supportive interactions with the child. At a group coaching session, a coach reviews the edited clips in detail with the caregivers.
11306313|NCT03106636|EG000|Reported Event|KEEP-P|The KEEP-P caregiver support groups employ a manualized 12-session, weekly curriculum for foster, kinship, and biological caregivers. Each weekly 2 hour session is structured so that the curriculum content is integrated into group discussions, and primary concepts are illustrated via role-play. Home practice assignments are given weekly and relate to the topics covered during sessions to assist parents in implementing the behavioral procedures taught.
11306314|NCT03106636|EG001|Reported Event|KEEP-P+|The KEEP-P+ group received the same 12-session, weekly curriculum as the KEEP-P group, and also received an additional video coaching component. The video coaching employs video of caregivers' natural interactions with their child to show ways that they are supporting children's healthy development. It is a simple and practical approach that emphasizes caregivers' strengths and capabilities. It begins with video recordings of a caregiver and child in their home or other natural setting. The film is carefully edited to show brief clips in which the caregiver is engaged in developmentally supportive interactions with the child. At a group coaching session, a coach reviews the edited clips in detail with the caregivers.
11306315|NCT03106753|BG000|Baseline|Spinal Anesthesia Immediately for ECV.|The patient had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted.
11306316|NCT03106753|BG001|Baseline|Spinal Anesthesia if no Intervention Fails for ECV.|The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. This group includes both those who did not require spinal anesthesia and those who subsequently require spinal anesthesia.
11306317|NCT03106753|BG002|Baseline|Total|Total of all reporting groups
11306318|NCT03106753|FG000|Participant Flow|Spinal Anesthesia Immediately for ECV.|The patient had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted. Under ultrasound guidance the provider attempt to lift the breech upward from the pelvis with one hand and guide the head with the other hand to produce a forward roll. If forward roll fails, a backward roll somersault may be attempted. ECV attempt will be abandoned if there is significant fetal bradycardia, discomfort to the patient, or if the procedure cannot be completed easily with these maneuvers. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring.
11306319|NCT03106753|FG001|Participant Flow|Spinal Anesthesia if no Intervention Fails for ECV.|The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted using the same procedure. If successful, the patient was monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. Once attempt is complete, whether successful or not, the patient was monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring.
11306320|NCT03106753|OG000|Outcome|Spinal Anesthesia Immediately for ECV.|The patient had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted.
11306321|NCT03106753|OG001|Outcome|Spinal Anesthesia if no Intervention Fails for ECV.|The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. This group includes both those who did not require spinal anesthesia and those who subsequently require spinal anesthesia.
11306322|NCT03106753|OG000|Outcome|Spinal Anesthesia Immediately for ECV.|Newborn of the patients that had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted.
11306323|NCT03106753|OG001|Outcome|Spinal Anesthesia if no Intervention Fails for ECV.|Newborns of the patient that was administered terbutaline 0.25 mg subcutaneously and the version was attempted. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. This group includes both those who did not require spinal anesthesia and those who subsequently require spinal anesthesia.
11306324|NCT03106753|EG000|Reported Event|Spinal Anesthesia Immediately for ECV.|"The patient had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted.~The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that waa what the researchers were looking at, the researchers were not comparing spinal versus no spinal."
11306325|NCT03106753|EG001|Reported Event|Spinal Anesthesia if no Intervention Fails for ECV.|"The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. This group includes both those who did not require spinal anesthesia and those who subsequently require spinal anesthesia.~The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that waa what the researchers were looking at, the researchers were not comparing spinal versus no spinal."
11306326|NCT03106844|BG000|Baseline|Treatment|"All patients in this study will receive Fecal Microbiota Tranplantation~Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT"
11306327|NCT03106844|FG000|Participant Flow|Treatment|"All patients in this study will receive Fecal Microbiota Tranplantation~Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT"
11306328|NCT03106844|OG000|Outcome|Treatment|"All patients in this study will receive Fecal Microbiota Tranplantation~Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT"
11306329|NCT03106844|EG000|Reported Event|Treatment|"All patients in this study will receive Fecal Microbiota Tranplantation~Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT"
11306330|NCT03106870|BG000|Baseline|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
11306331|NCT03106870|BG001|Baseline|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
11306332|NCT03106870|BG002|Baseline|Total|Total of all reporting groups
11306333|NCT03106870|FG000|Participant Flow|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
11306334|NCT03106870|FG001|Participant Flow|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
10848500|NCT00290199|OG001|Outcome|No Foley|No transcervical foley catheter inserted to induce labor
10848501|NCT00290199|OG000|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
10848502|NCT00290199|OG001|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
11306335|NCT03106870|OG000|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
11306336|NCT03106870|OG001|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
11306337|NCT03106870|EG000|Reported Event|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
11306338|NCT03106870|EG001|Reported Event|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
11306339|NCT03107026|BG000|Baseline|Placebo|Placebo, once daily
11306340|NCT03107026|BG001|Baseline|Dasotraline 4mg|Dasotraline 4mg once daily
11306341|NCT03107026|BG002|Baseline|Dasotraline 6mg|Dasotraline 6mg once daily
11306342|NCT03107026|BG003|Baseline|Total|Total of all reporting groups
11306343|NCT03107026|FG000|Participant Flow|Placebo|Placebo, once daily
11306344|NCT03107026|FG001|Participant Flow|Dasotraline 4mg|Dasotraline 4mg once daily
11306345|NCT03107026|FG002|Participant Flow|Dasotraline 6mg|Dasotraline 6mg once daily
11306346|NCT03107026|OG000|Outcome|Placebo|Placebo, once daily
11306347|NCT03107026|OG001|Outcome|Dasotraline 4mg|Dasotraline 4mg once daily
11306348|NCT03107026|OG002|Outcome|Dasotraline 6mg|Dasotraline 6mg once daily
11306349|NCT03107026|EG000|Reported Event|Placebo|Placebo, once daily
11306350|NCT03107026|EG001|Reported Event|Dasotraline 4mg|Dasotraline 4mg once daily
11306351|NCT03107026|EG002|Reported Event|Dasotraline 6mg|Dasotraline 6mg once daily
11306352|NCT03107052|BG000|Baseline|Fremanezumab 225 mg Monthly|Participants with ECH or CCH who received fremanezumab at 900 mg IV infusion at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection [225 mg/1.5 mL] at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.
11306353|NCT03107052|BG001|Baseline|Fremanezumab 675/225 mg Monthly|Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 12, 24, and 36) through Week 36.
11306354|NCT03107052|BG002|Baseline|Fremanezumab 675 mg Quarterly|Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; received fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 0 and 36; and single placebo SC injection at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.
11306355|NCT03107052|BG003|Baseline|Total|Total of all reporting groups
11306356|NCT03107052|FG000|Participant Flow|Fremanezumab 225 mg Monthly|Participants with ECH or CCH who received fremanezumab at 900 mg intravenous (IV) infusion at Week 0 and fremanezumab at 225 mg subcutaneous (SC) injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 milliliter {mL}] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection [225 mg/1.5 mL] at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.
11306357|NCT03107052|FG001|Participant Flow|Fremanezumab 675/225 mg Monthly|Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 12, 24, and 36) through Week 36.
11306358|NCT03107052|FG002|Participant Flow|Fremanezumab 675 mg Quarterly|Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; received fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 0 and 36; and single placebo SC injection at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.
11306359|NCT03107052|OG000|Outcome|Fremanezumab 225 mg Monthly|Participants with ECH or CCH who received fremanezumab at 900 mg IV infusion at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection [225 mg/1.5 mL] at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.
11306360|NCT03107052|OG001|Outcome|Fremanezumab 675/225 mg Monthly|Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 12, 24, and 36) through Week 36.
11306361|NCT03107052|OG002|Outcome|Fremanezumab 675 mg Quarterly|Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; received fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 0 and 36; and single placebo SC injection at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.
11306362|NCT03107052|EG000|Reported Event|Fremanezumab 225 mg Monthly|Participants with ECH or CCH who received fremanezumab at 900 mg IV infusion at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and fremanezumab at 225 mg SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection [225 mg/1.5 mL] at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.
11306363|NCT03107052|EG001|Reported Event|Fremanezumab 675/225 mg Monthly|Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; received fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 12, 24, and 36) through Week 36.
11306364|NCT03107052|EG002|Reported Event|Fremanezumab 675 mg Quarterly|Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; received fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg [225 mg/1.5 mL] at Weeks 0 and 36; and single placebo SC injection at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.
11306365|NCT03107091|BG000|Baseline|Terlipressin Acetate Continuous Infusion|"Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days~Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days"
11306366|NCT03107091|FG000|Participant Flow|Terlipressin Acetate Continuous Infusion|"Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days~Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days"
11306367|NCT03107091|OG000|Outcome|Terlipressin Acetate Continuous Infusion|Continuous infusion of terlipressin
11306368|NCT03107091|OG000|Outcome|Terlipressin Acetate Continuous Infusion|"Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days~Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days"
11306369|NCT03107091|EG000|Reported Event|Terlipressin Acetate Continuous Infusion|"Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days~Terlipressin acetate continuous infusion: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days"
11306370|NCT03107377|BG000|Baseline|EVO100|"A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~EVO100l: 5 g dose applied up to 1 hour prior to coitus"
10848503|NCT00290199|EG000|Reported Event|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
11306371|NCT03107377|BG001|Baseline|Placebo|"An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~Placebo: 5 g dose applied up to 1 hour prior to coitus"
11306372|NCT03107377|BG002|Baseline|Total|Total of all reporting groups
11306373|NCT03107377|FG000|Participant Flow|EVO100|"A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~EVO100: 5 g dose applied up to 1 hour prior to coitus"
11306374|NCT03107377|FG001|Participant Flow|Placebo|"An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~Placebo: 5 g dose applied up to 1 hour prior to coitus"
11306375|NCT03107377|OG000|Outcome|EVO100|"A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~EVO100: 5 g dose applied up to 1 hour prior to coitus"
11306376|NCT03107377|OG001|Outcome|Placebo|"An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~Placebo: 5 g dose applied up to 1 hour prior to coitus"
11306377|NCT03107377|EG000|Reported Event|EVO100|"A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~EVO100: 5 g dose applied up to 1 hour prior to coitus"
11306378|NCT03107377|EG001|Reported Event|Placebo|"An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.~Placebo: 5 g dose applied up to 1 hour prior to coitus"
11306379|NCT03107715|BG000|Baseline|Breastfeeding Champion|"The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.~Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher"
11306380|NCT03107715|BG001|Baseline|Positive Messaging|"The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.~Positive Messaging: iPad based behavioral intervention facilitated by researcher"
11306381|NCT03107715|BG002|Baseline|Total|Total of all reporting groups
11306382|NCT03107715|FG000|Participant Flow|Breastfeeding Champion|"The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.~Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher"
11306383|NCT03107715|FG001|Participant Flow|Positive Messaging|"The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.~Positive Messaging: iPad based behavioral intervention facilitated by researcher"
11306384|NCT03107715|OG000|Outcome|Breastfeeding Champion|"The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.~Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher"
11306385|NCT03107715|OG001|Outcome|Positive Messaging|"The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.~Positive Messaging: iPad based behavioral intervention facilitated by researcher"
11306386|NCT03107715|EG000|Reported Event|Breastfeeding Champion|"The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.~Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher"
11306387|NCT03107715|EG001|Reported Event|Positive Messaging|"The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.~Positive Messaging: iPad based behavioral intervention facilitated by researcher"
11306388|NCT03107754|BG000|Baseline|Standard Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol~Lidocaine: Paracervical block will be injected at 4 points at the cervicovaginal junction to decrease pain"
11306389|NCT03107754|BG001|Baseline|Buffered Lidocaine Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate~Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 4 points at the cervicovaginal junction to decrease pain"
11306390|NCT03107754|BG002|Baseline|Total|Total of all reporting groups
10848504|NCT00290199|EG001|Reported Event|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
10848505|NCT00290238|BG000|Baseline|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
11306391|NCT03107754|FG000|Participant Flow|Standard Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol~Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306392|NCT03107754|FG001|Participant Flow|Buffered Lidocaine Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate~Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306393|NCT03107754|OG000|Outcome|Standard Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol~Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306394|NCT03107754|OG001|Outcome|Buffered Lidocaine Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate~Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306395|NCT03107754|EG000|Reported Event|Standard Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol~Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306396|NCT03107754|EG001|Reported Event|Buffered Lidocaine Paracervical Block|"A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate~Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain"
11306397|NCT03107793|BG000|Baseline|Induction Treatment: Ustekinumab (6 Milligram [mg]/Kilogram [kg])|Participants were administered with approximately 6 milligram per kilogram (mg/kg) intravenous (IV) injection at Week 0 and 90 mg subcutaneous (SC) injection at Week 8. At Week 16, participants who did not achieved a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.
11306398|NCT03107793|FG000|Participant Flow|Induction Treatment: Ustekinumab (6 Milligram [mg]/Kilogram [kg])|Participants were administered with approximately 6 milligram per kilogram (mg/kg) intravenous (IV) injection at Week 0 and 90 mg subcutaneous (SC) injection at Week 8. At Week 16, participants who did not achieved a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.
10848506|NCT00290238|BG001|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
11306399|NCT03107793|FG001|Participant Flow|Treat to Target|Participants with less than (<) 25% improvement in simple endoscopic score for Crohn's disease (SES-CD) score at Week 16 versus baseline received ustekinumab SC dose 8-weekly maintenance treatment while participants with >= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24 for participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.
11306400|NCT03107793|FG002|Participant Flow|Routine Care|Participants received ustekinumab SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (ie, 8 weeks after the first SC dose), participants who have not shown adequate response based on the investigator's judgment may receive a second ustekinumab SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lose response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
11306401|NCT03107793|OG000|Outcome|Treat to Target|Participants with less than (<) 25% improvement in simple endoscopic score for Crohn's disease (SES-CD) score at Week 16 versus baseline received ustekinumab SC dose 8-weekly maintenance treatment while participants with >= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24 for participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.
11306402|NCT03107793|OG001|Outcome|Routine Care|Participants received ustekinumab SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (ie, 8 weeks after the first SC dose), participants who have not shown adequate response based on the investigator's judgment may receive a second ustekinumab SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lose response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
11333050|NCT03507036|OG000|Outcome|Treatment|All patients will undergo treatment with Profound system device on both knees using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C). All subjects will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period.
10848507|NCT00290238|BG002|Baseline|Total|Total of all reporting groups
11306403|NCT03107793|EG000|Reported Event|Induction Period (0-16 Weeks): Ustekinumab (6 Milligram [mg]/Kilogram [kg])|Participants were administered with approximately 6 milligram per kilogram (mg/kg) intravenous (IV) injection at Week 0 and 90 mg subcutaneous (SC) injection at Week 8. At Week 16, participants who did not achieved a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.
11306404|NCT03107793|EG001|Reported Event|Maintenance Period: Treat to Target (0-48 Weeks)|Participants with less than (<) 25% improvement in simple endoscopic score for Crohn's disease (SES-CD) score at Week 16 versus baseline received ustekinumab SC dose 8-weekly maintenance treatment while participants with >= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24 for participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.
11306405|NCT03107793|EG002|Reported Event|Maintenance Period: Routine Care (0-48 Weeks)|Participants received ustekinumab SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (ie, 8 weeks after the first SC dose), participants who have not shown adequate response based on the investigator's judgment may receive a second ustekinumab SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lose response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
11306406|NCT03108027|BG000|Baseline|All Participants|All participants randomized to one of six treatment sequences
11306407|NCT03108027|FG000|Participant Flow|Sequence 1|Patients received in a sequential order the following interventional treatments: A,B and C.
11306408|NCT03108027|FG001|Participant Flow|Sequence 2|Patients received in a sequential order the following interventional treatments: B, A and C.
11306409|NCT03108027|FG002|Participant Flow|Sequence 3|Patients received in a sequential order the following interventional treatments: C, B and A.
11306410|NCT03108027|FG003|Participant Flow|Sequence 4|Patients received in a sequential order the following interventional treatments : C, A and B.
11306411|NCT03108027|FG004|Participant Flow|Sequence 5|Patients received in a sequential order the following interventional treatments: A, C and B.
11306412|NCT03108027|FG005|Participant Flow|Sequence 6|Patients received in a sequential order the following interventional treatments: B, C and A.
11306413|NCT03108027|OG000|Outcome|QVM149 am|QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)
11306414|NCT03108027|OG001|Outcome|QVM149 pm|QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)
11306415|NCT03108027|OG002|Outcome|Placebo|Placebo administered in the morning and in the evening.
11306416|NCT03108027|EG000|Reported Event|QVM149 a.m.|QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)
11306417|NCT03108027|EG001|Reported Event|QVM149 p.m.|QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)
11306418|NCT03108027|EG002|Reported Event|Placebo|Placebo administered in the morning and in the evening
11306419|NCT03108157|BG000|Baseline|GROUP A: Intervention Group|Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306420|NCT03108157|BG001|Baseline|GROUP B: Non Intervention Group|Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306421|NCT03108157|BG002|Baseline|Total|Total of all reporting groups
11306422|NCT03108157|FG000|Participant Flow|GROUP A: Intervention Group|Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306423|NCT03108157|FG001|Participant Flow|GROUP B: no Intervention Group|Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306424|NCT03108157|OG000|Outcome|GROUP A: Intervention Group|Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306425|NCT03108157|OG001|Outcome|GROUP B: no Intervention Group|Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306426|NCT03108157|OG000|Outcome|GROUP A: Intervention Group|"Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.~Endometrial scratch: Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer."
11306427|NCT03108157|EG000|Reported Event|GROUP A: Intervention Group|Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306428|NCT03108157|EG001|Reported Event|GROUP B: no Intervention Group|Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
11306429|NCT03108469|BG000|Baseline|IONIS-PKKRx (ISIS 546254)|Those randomized to IONIS-PKKRx (ISIS 546254) received subcutaneous injections containing 1.00 mL (200mg/mL) weekly for weeks 1-16.
11306430|NCT03108469|BG001|Baseline|Placebo|Those randomized to placebo will receive subcutaneous injections containing 1.00 mL weekly for weeks 1-16.
11306431|NCT03108469|BG002|Baseline|Total|Total of all reporting groups
11306432|NCT03108469|FG000|Participant Flow|IONIS-PKKRx (ISIS 546254)|Those randomized to IONIS-PKKRx (ISIS 546254) received subcutaneous injections containing 1.00 mL (200mg/mL) weekly for weeks 1-16.
11306433|NCT03108469|FG001|Participant Flow|Placebo|Those randomized to placebo will receive subcutaneous injections containing 1.00 mL weekly for weeks 1-16.
11306434|NCT03108469|OG000|Outcome|IONIS-PKKRx (ISIS 546254)|Those randomized to IONIS-PKKRx (ISIS 546254) received subcutaneous injections containing 1.00 mL (200mg/mL) weekly for weeks 1-16.
11306435|NCT03108469|OG001|Outcome|Placebo|Those randomized to placebo will receive subcutaneous injections containing 1.00 mL weekly for weeks 1-16.
11306436|NCT03108469|EG000|Reported Event|IONIS-PKKRx (ISIS 546254)|Those randomized to IONIS-PKKRx (ISIS 546254) received subcutaneous injections containing 1.00 mL (200mg/mL) weekly for weeks 1-16.
11306437|NCT03108469|EG001|Reported Event|Placebo|Those randomized to placebo will receive subcutaneous injections containing 1.00 mL weekly for weeks 1-16.
11306438|NCT03108482|BG000|Baseline|Co-crystal E-58425 (Tramadol/Celecoxib)|"Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose was 400 mg of Co-crystal E-58425.~Co-crystal E-58425 (Tramadol/Celecoxib): Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours."
11306439|NCT03108482|BG001|Baseline|Tramadol (Ultram®)|"Tramadol: One tablet of 50 mg every 6 hours. The total daily dose was 200 mg of tramadol.~Tramadol (Ultram®): Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours."
11306440|NCT03108482|BG002|Baseline|Celecoxib (Celebrex®)|"Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose was 200 mg of celecoxib.~Celecoxib (Celebrex®): Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours."
11306441|NCT03108482|BG003|Baseline|Placebo|"Placebo: One or two tablets of 100 mg every 6 hours.~Placebo: Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours."
11306442|NCT03108482|BG004|Baseline|Total|Total of all reporting groups
11306443|NCT03108482|FG000|Participant Flow|Co-crystal E-58425 (Tramadol/Celecoxib)|"Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose was 400 mg of Co-crystal E-58425.~Co-crystal E-58425 (Tramadol/Celecoxib): Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours."
11306444|NCT03108482|FG001|Participant Flow|Tramadol (Ultram®)|"Tramadol: One tablet of 50 mg every 6 hours. The total daily dose was 200 mg of tramadol.~Tramadol (Ultram®): Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours."
11306445|NCT03108482|FG002|Participant Flow|Celecoxib (Celebrex®)|"Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose was 200 mg of celecoxib.~Celecoxib (Celebrex®): Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours."
11306446|NCT03108482|FG003|Participant Flow|Placebo|"Placebo: One or two tablets of 100 mg every 6 hours.~Placebo: Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours."
11306447|NCT03108482|OG000|Outcome|Co-crystal E-58425 (Tramadol/Celecoxib)|"Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose was 400 mg of Co-crystal E-58425.~Co-crystal E-58425 (Tramadol/Celecoxib): Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours."
11306448|NCT03108482|OG001|Outcome|Tramadol (Ultram®)|"Tramadol: One tablet of 50 mg every 6 hours. The total daily dose was 200 mg of tramadol.~Tramadol (Ultram®): Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours."
11306449|NCT03108482|OG002|Outcome|Celecoxib (Celebrex®)|"Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose was 200 mg of celecoxib.~Celecoxib (Celebrex®): Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours."
11306450|NCT03108482|OG003|Outcome|Placebo|"Placebo: One or two tablets of 100 mg every 6 hours.~Placebo: Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours."
11306451|NCT03108482|EG000|Reported Event|Co-crystal E-58425 (Tramadol/Celecoxib)|"Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose was 400 mg of Co-crystal E-58425.~Co-crystal E-58425 (Tramadol/Celecoxib): Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours."
11306452|NCT03108482|EG001|Reported Event|Tramadol (Ultram®)|"Tramadol: One tablet of 50 mg every 6 hours. The total daily dose was 200 mg of tramadol.~Tramadol (Ultram®): Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours."
11306453|NCT03108482|EG002|Reported Event|Celecoxib (Celebrex®)|"Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose was 200 mg of celecoxib.~Celecoxib (Celebrex®): Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours."
11306454|NCT03108482|EG003|Reported Event|Placebo|"Placebo: One or two tablets of 100 mg every 6 hours.~Placebo: Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours."
11306455|NCT03108521|BG000|Baseline|Sitagliptin Group|"Patients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months.~Sitagliptin: 100mg.QD for 3 months"
11306456|NCT03108521|BG001|Baseline|Non-T2DM Group|Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.
11306457|NCT03108521|BG002|Baseline|Total|Total of all reporting groups
11306458|NCT03108521|FG000|Participant Flow|Sitagliptin Group|"Patients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months.~Sitagliptin: 100mg.QD for 3 months"
11306459|NCT03108521|FG001|Participant Flow|Non-T2D Group|Aims to study correlationship between SNP and T2DM onset.
11306460|NCT03108521|OG000|Outcome|Sitagliptin Group|"Patients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months.~Sitagliptin: 100mg.QD for 3 months"
11306461|NCT03108521|OG000|Outcome|Sitagliptin Group|Patients in this group will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
11306462|NCT03108521|OG001|Outcome|Non-T2DM Group|Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
11306463|NCT03108521|OG000|Outcome|Sitagliptin Group|Patients in this group will check fasting and postprandial 2-hour blood glucose
11306464|NCT03108521|OG000|Outcome|Sitagliptin Group|To compare the baseline and endpoint insulin secretion after taking sitagliptin orally
11306465|NCT03108521|OG000|Outcome|Sitagliptin Group|Patients in this group will compare the baseline and endpoint C peptide secretion after taking sitagliptin orally
11306466|NCT03108521|EG000|Reported Event|Sitagliptin Group|"Patients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months.~Sitagliptin: 100mg.QD for 3 months"
11306467|NCT03108521|EG001|Reported Event|Non-T2DM Group|Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.
11306468|NCT03108924|BG000|Baseline|[Part 1] Moderate RI|Participants with moderate RI received a single oral dose of gefapixant 50 mg
11306469|NCT03108924|BG001|Baseline|[Part 1] Severe RI|Participants with severe RI received a single oral dose of gefapixant 50 mg
11306470|NCT03108924|BG002|Baseline|[Part 2] ESRD|Participants with ESRD requiring HD received a single oral dose of gefapixant 50 mg immediately after HD in Period 1, followed by a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between the Periods 1 and 2 MK-7264 dose administrations there was approximately a 7-day washout period with 3 dialysis sessions.
11306471|NCT03108924|BG003|Baseline|[Part 1 and Part 2] Healthy Controls|Healthy participants were matched to participants with moderate and severe RI (Part 1) and participants with ESRD (Part 2).
11306472|NCT03108924|BG004|Baseline|Total|Total of all reporting groups
11306473|NCT03108924|FG000|Participant Flow|[Part 1] Moderate RI|Participants with moderate renal impairment (RI) received a single oral dose of gefapixant 50 mg
11306474|NCT03108924|FG001|Participant Flow|[Part 1] Severe RI|Participants with severe RI received a single oral dose of gefapixant 50 mg
11306475|NCT03108924|FG002|Participant Flow|[Part 2] ESRD|Participants with ESRD requiring HD received a single oral dose of gefapixant 50 mg immediately after HD in Period 1, followed by a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between the Periods 1 and 2 MK-7264 dose administrations there was approximately a 7-day washout period with 3 dialysis sessions.
11306476|NCT03108924|FG003|Participant Flow|[Part 1 and Part 2] Healthy Controls|Healthy participants were matched to participants with moderate and severe RI (Part 1) and participants with ESRD (Part 2).
11306477|NCT03108924|OG000|Outcome|[Part 1] Moderate RI|Participants with moderate RI received a single oral dose of gefapixant 50 mg
11306478|NCT03108924|OG001|Outcome|[Part 1] Severe RI|Participants with severe RI received a single oral dose of gefapixant 50 mg
11306479|NCT03108924|OG002|Outcome|[Part 2, Period 1] ESRD Non-HD|Participants with ESRD requiring HD, but not on HD, received a single oral dose of gefapixant 50 mg immediately after the scheduled HD, in Period 1
11306480|NCT03108924|OG003|Outcome|[Part 2, Period 2] ESRD HD|Participants with ESRD requiring HD, and on HD, received a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between gefapixant dose administrations in Periods 1 and 2, there was approximately a 7-day washout period with 3 dialysis sessions.
11306481|NCT03108924|OG004|Outcome|[Part 1 and Part 2] Healthy Controls|Healthy participants were matched to participants with moderate and severe RI (Part 1) and participants with ESRD (Part 2).
11306482|NCT03108924|OG000|Outcome|[Part 2, Period 1] ESRD Non-HD|Participants with ESRD requiring HD, but not on HD, received a single oral dose of gefapixant 50 mg immediately after the scheduled HD, in Period 1
11306483|NCT03108924|OG001|Outcome|[Part 2, Period 2] ESRD HD|Participants with ESRD requiring HD, and on HD, received a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between gefapixant dose administrations in Periods 1 and 2, there was approximately a 7-day washout period with 3 dialysis sessions.
11306484|NCT03108924|OG002|Outcome|[Part 1] Healthy Controls|Healthy participants were matched to participants with moderate and severe RI (Part 1).
11306485|NCT03108924|OG002|Outcome|[Part 1] Healthy Controls|Healthy Control participants received a single oral dose of gefapixant 50 mg
11306486|NCT03108924|OG003|Outcome|[Part 1] Healthy Controls|Healthy Control participants received a single oral dose of gefapixant 50 mg
11306487|NCT03108924|OG004|Outcome|[Part 1] Healthy Controls|Healthy Control participants received a single oral dose of gefapixant 50 mg
11306488|NCT03108924|OG002|Outcome|[Part 2] ESRD|Participants with ESRD requiring HD received a single oral dose of gefapixant 50 mg immediately after HD in Period 1, followed by a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between the Periods 1 and 2 MK-7264 dose administrations there was approximately a 7-day washout period with 3 dialysis sessions.
11306489|NCT03108924|OG003|Outcome|[Part 1 and Part 2] Healthy Controls|Healthy participants were matched to participants with moderate and severe RI (Part 1) and participants with ESRD (Part 2).
11306490|NCT03108924|EG000|Reported Event|MK-7264 50 mg: Moderate RI|Participants with moderate RI received a single oral dose of gefapixant 50 mg
11306491|NCT03108924|EG001|Reported Event|MK-7264 50 mg: Severe RI|Participants with severe RI received a single oral dose of gefapixant 50 mg
11306492|NCT03108924|EG002|Reported Event|MK-7264 50 mg: ESRD|Participants with ESRD requiring HD received a single oral dose of gefapixant 50 mg immediately after HD in Period 1, followed by a single oral dose of gefapixant 50 mg two hours prior to HD in Period 2. Between the Periods 1 and 2 MK-7264 dose administrations there was approximately a 7-day washout period with 3 dialysis sessions.
11306493|NCT03108924|EG003|Reported Event|Healthy Controls|Healthy control participants received a single oral dose of gefapixant 50 mg
11306494|NCT03109015|BG000|Baseline|Schedule 4/2|Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
11306495|NCT03109015|BG001|Baseline|Schedule 2/1|Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
11306496|NCT03109015|BG002|Baseline|Total|Total of all reporting groups
11306497|NCT03109015|FG000|Participant Flow|Schedule 4/2|Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
11306498|NCT03109015|FG001|Participant Flow|Schedule 2/1|Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
11306499|NCT03109015|OG000|Outcome|Schedule 4/2|Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
11306500|NCT03109015|OG001|Outcome|Schedule 2/1|Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
11306501|NCT03109015|EG000|Reported Event|Schedule 4/2|Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
11306502|NCT03109015|EG001|Reported Event|Schedule 2/1|Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
11306503|NCT03109184|BG000|Baseline|Waitlist Control|Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
11306504|NCT03109184|BG001|Baseline|Project STRONG|"The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.~Project STRONG: The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations."
11306505|NCT03109184|BG002|Baseline|Total|Total of all reporting groups
11306506|NCT03109184|FG000|Participant Flow|Waitlist Control|Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
11306507|NCT03109184|FG001|Participant Flow|Project STRONG|"The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.~Project STRONG: The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations."
11306508|NCT03109184|OG000|Outcome|Waitlist Control|Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
11333051|NCT03507036|OG000|Outcome|Treatment|All patients will undergo treatment with Profound system device n both knees. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period.
11306509|NCT03109184|OG001|Outcome|Project STRONG|"The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.~Project STRONG: The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations."
11306510|NCT03109184|EG000|Reported Event|Waitlist Control|Parents-teen dyads enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
11306511|NCT03109184|EG001|Reported Event|Project STRONG|The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parent-teen dyads to practice and apply strategies to developmentally appropriate situations.
11306512|NCT03109769|BG000|Baseline|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
11306513|NCT03109769|BG001|Baseline|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
11306514|NCT03109769|BG002|Baseline|Total|Total of all reporting groups
11306515|NCT03109769|FG000|Participant Flow|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
11306516|NCT03109769|FG001|Participant Flow|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
11306517|NCT03109769|OG000|Outcome|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
11306518|NCT03109769|OG001|Outcome|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
11306519|NCT03109769|EG000|Reported Event|Mobile Phone Application|"Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.~Mobile phone application"
11306520|NCT03109769|EG001|Reported Event|Verbal Oral Hygiene Instructions|"Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.~Verbal oral hygiene instructions"
11306521|NCT03109951|BG000|Baseline|Diabetes Group|"Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.~Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol."
11306522|NCT03109951|FG000|Participant Flow|Diabetes Group|"Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.~Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol."
11306523|NCT03109951|OG000|Outcome|Diabetes Group|"Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.~Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol."
11306524|NCT03109951|EG000|Reported Event|Diabetes Group|"Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.~Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol."
11306525|NCT03110003|BG000|Baseline|10 mg Bupivacaine|"Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.~10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space"
11306526|NCT03110003|BG001|Baseline|5 mg Bupivacaine|"Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.~5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space."
11306527|NCT03110003|BG002|Baseline|Total|Total of all reporting groups
11306528|NCT03110003|FG000|Participant Flow|10 mg Bupivacaine|"Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.~10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space"
11306529|NCT03110003|FG001|Participant Flow|5 mg Bupivacaine|"Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.~5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space."
11306530|NCT03110003|OG000|Outcome|10 mg Bupivacaine|"Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.~10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space"
11306531|NCT03110003|OG001|Outcome|5 mg Bupivacaine|"Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.~5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space."
11306532|NCT03110003|EG000|Reported Event|10 mg Bupivacaine|"Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.~10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space"
11306533|NCT03110003|EG001|Reported Event|5 mg Bupivacaine|"Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.~5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space."
11306534|NCT03110029|BG000|Baseline|Wearing Toenail Polish|"Subject will have Efinaconazole 10% application and nail polish~Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution~Application of nail polish"
11306535|NCT03110029|BG001|Baseline|Abstain From Wearing Toenail Polish|"Subject will have Efinaconazole 10% application and no nail polish~Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution"
11306536|NCT03110029|BG002|Baseline|Total|Total of all reporting groups
11306537|NCT03110029|FG000|Participant Flow|Study Group (Frequently Wears Toenail Polish)|"Patients who self-identified as frequently wearing toenail polish were placed in the study group.~Inclusion criteria consisted of being female and aged 19-70 with distal and lateral subungual onychomycosis (DLSO) effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks."
11306538|NCT03110029|FG001|Participant Flow|Control Group (no Toenail Polish)|"The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study.~Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks."
11306539|NCT03110029|OG000|Outcome|Wearing Toenail Polish|"Subject will have Efinaconazole 10% application and nail polish~Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution~Application of nail polish: Application of nail polish only"
11306540|NCT03110029|OG001|Outcome|Abstain From Wearing Toenail Polish|"Subject will have Efinaconazole 10% application and no nail polish~Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution"
11306541|NCT03110029|EG000|Reported Event|Efinaconazole 10% and Nail Polish|"Patients who self-identified as frequently wearing toenail polish were placed in the study group. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks."
11306542|NCT03110029|EG001|Reported Event|Efinaconazole 10% Without Nail Polish|"The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study.~Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks."
11306543|NCT03110185|BG000|Baseline|Delirium|"Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306544|NCT03110185|BG001|Baseline|No Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306545|NCT03110185|BG002|Baseline|Total|Total of all reporting groups
11306546|NCT03110185|FG000|Participant Flow|Delirium|"Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306547|NCT03110185|FG001|Participant Flow|No Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306548|NCT03110185|OG000|Outcome|Delirium|"Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.~EEG, fcDOT, fcMRI: Brain activity will be recorded using EEG, fcDOT and MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306549|NCT03110185|OG001|Outcome|No Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~EEG, fcDOT, fcMRI: Brain activity will be recorded using EEG, fcDOT and MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306550|NCT03110185|OG000|Outcome|Delirium|"Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306551|NCT03110185|OG001|Outcome|No Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306552|NCT03110185|OG001|Outcome|no Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306553|NCT03110185|EG000|Reported Event|Delirium|"Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
11306554|NCT03110185|EG001|Reported Event|no Delirium|"Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm~fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients."
10971987|NCT00918723|BG000|Baseline|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
11306555|NCT03110458|BG000|Baseline|SENS-111 100mg|"SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)~SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study."
11306556|NCT03110458|BG001|Baseline|SENS-111 200mg|"SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)~SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study."
11306557|NCT03110458|BG002|Baseline|Placebo|"Placebo: 2 placebo Oral Dispersible Tablets~Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study."
11306558|NCT03110458|BG003|Baseline|Total|Total of all reporting groups
11306559|NCT03110458|FG000|Participant Flow|SENS-111 100mg|"SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)~SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study."
11306560|NCT03110458|FG001|Participant Flow|SENS-111 200mg|"SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)~SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study."
11306561|NCT03110458|FG002|Participant Flow|Placebo|"Placebo: 2 placebo Oral Dispersible Tablets~Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study."
11306562|NCT03110458|OG000|Outcome|SENS-111 100mg|"SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)~SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study."
11306563|NCT03110458|OG001|Outcome|SENS-111 200mg|"SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)~SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study."
11306564|NCT03110458|OG002|Outcome|Placebo|"Placebo: 2 placebo Oral Dispersible Tablets~Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study."
11306565|NCT03110458|EG000|Reported Event|SENS-111 100mg|"SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)~SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study."
11306566|NCT03110458|EG001|Reported Event|SENS-111 200mg|"SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)~SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study."
11306567|NCT03110458|EG002|Reported Event|Placebo|"Placebo: 2 placebo Oral Dispersible Tablets~Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study."
11306568|NCT03110471|BG000|Baseline|Observed Residents|Administration of ADRe by nurses to 30 residents in care homes observed
11306569|NCT03110471|BG001|Baseline|Service Providers and Users|Policy context explored in interviews with service users, nurse managers strategic leads
11306570|NCT03110471|BG002|Baseline|Total|Total of all reporting groups
11306571|NCT03110471|FG000|Participant Flow|Observed Residents|The administration of ADRe by nurses with 30 residents was observed in ten volunteer care homes in South West Wales, U.K. Five care homes were recruited to the study from our earlier randomised controlled trial [24], and five were newly recruited. All observed residents were receiving prescribed mental health medicines. The wider policy context was explored in 30 interviews with service users, including family members, nurse managers and strategic health care leads in South Wales
11306572|NCT03110471|FG001|Participant Flow|Service Providers|pharmacists nurses strategic leads
11306573|NCT03110471|OG000|Outcome|Whole Study - Observed Residents|Care home (long-stay) residents observed for adverse drug reactions.
11306574|NCT03110471|EG000|Reported Event|Observed Residents|This observation study had only one arm (intervention).
11306575|NCT03110562|BG000|Baseline|SVd Arm: Selinexor + Bortezomib + Dexamethasone|Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306576|NCT03110562|BG001|Baseline|Vd Arm: Bortezomib + Dexamethasone|Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306577|NCT03110562|BG002|Baseline|Total|Total of all reporting groups
11306578|NCT03110562|FG000|Participant Flow|SVd Arm: Selinexor + Bortezomib + Dexamethasone|Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306579|NCT03110562|FG001|Participant Flow|Vd Arm: Bortezomib + Dexamethasone|Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by greater than or equal to (>=) 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306580|NCT03110562|OG000|Outcome|SVd Arm: Selinexor + Bortezomib + Dexamethasone|Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306581|NCT03110562|OG001|Outcome|Vd Arm: Bortezomib + Dexamethasone|Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
11306582|NCT03110562|EG000|Reported Event|SVd Arm: Selinexor + Bortezomib + Dexamethasone|Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study.
11306583|NCT03110562|EG001|Reported Event|Vd Arm: Bortezomib + Dexamethasone|Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study.
11306584|NCT03110601|BG000|Baseline|Enrolled Patients|Back pain patients that were trialed with Conventional SCS parameters, then after a washout period the same patients were trialed with PM-SCS parameters (Stimgenics SCS parameters).
11306585|NCT03110601|FG000|Participant Flow|Single Arm With Multiple Periods|Non-randomized cross-over study in which all eligible participants received the same order of procedures (i.e. Conventional SCS parameters for 4 days, then a washout period of 1 day, then PM-SCS parameters for 4 days).
11306586|NCT03110601|OG000|Outcome|Conventional SCS|Mean Back Pain Score after treatment Conventional SCS parameters
11306587|NCT03110601|OG001|Outcome|Stimgenics SCS|Mean Back Pain Score after treatments with Stimgenics SCS parameters
11306588|NCT03110601|EG000|Reported Event|Conventional SCS|Conventional SCS parameters for 4 days
11306589|NCT03110601|EG001|Reported Event|Washout Period|Washout period of 1 day
11306590|NCT03110601|EG002|Reported Event|Stimgenics SCS|Stimgenics SCS parameters for 4 days
11306591|NCT03110692|BG000|Baseline|Usual Practice (Control)|The usual practice group will rollover to the intervention arm after 3 months following the start of the default intervention in Feb 2017.
11306592|NCT03110692|BG001|Baseline|Intervention|"Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.~Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.~To start in Feb 2017 and continue in the intervention through Feb 2018"
11306593|NCT03110692|BG002|Baseline|Total|Total of all reporting groups
11306594|NCT03110692|FG000|Participant Flow|Usual Practice (Control)|The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017
11306595|NCT03110692|FG001|Participant Flow|Intervention|"Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.~Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.~To start in Feb 2017 and continue in the intervention through Feb 2018"
11306596|NCT03110692|OG000|Outcome|Usual Practice (Control)|The usual practice group will rollover to the intervention arm after 3 months from start of the default intervention in Feb 2017.
11306597|NCT03110692|OG001|Outcome|Intervention|"Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.~Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.~To start in Feb 2017 and continue in the intervention through Feb 2018"
11306598|NCT03110692|EG000|Reported Event|Usual Practice (Control)|The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017
11306599|NCT03110692|EG001|Reported Event|Intervention|"Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.~Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.~To start in Feb 2017 and continue in the intervention through Feb 2018"
11306600|NCT03110770|BG000|Baseline|Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306601|NCT03110770|BG001|Baseline|Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306602|NCT03110770|BG002|Baseline|Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306603|NCT03110770|BG003|Baseline|Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306604|NCT03110770|BG004|Baseline|Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections|"Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device~VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo"
11306605|NCT03110770|BG005|Baseline|Total|Total of all reporting groups
11306606|NCT03110770|FG000|Participant Flow|Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306607|NCT03110770|FG001|Participant Flow|Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306608|NCT03110770|FG002|Participant Flow|Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306609|NCT03110770|FG003|Participant Flow|Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306610|NCT03110770|FG004|Participant Flow|Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections|"Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device~VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo"
11306611|NCT03110770|OG000|Outcome|Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306612|NCT03110770|OG001|Outcome|Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306613|NCT03110770|OG002|Outcome|Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306614|NCT03110770|OG003|Outcome|Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306615|NCT03110770|OG004|Outcome|Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections|"Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device~VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo"
11306616|NCT03110770|OG000|Outcome|Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306617|NCT03110770|OG001|Outcome|Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections|"Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device~VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo"
11306618|NCT03110770|EG000|Reported Event|Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306619|NCT03110770|EG001|Reported Event|Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306620|NCT03110770|EG002|Reported Event|Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306621|NCT03110770|EG003|Reported Event|Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections|"ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device~VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV"
11306622|NCT03110770|EG004|Reported Event|Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections|"Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device~VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo"
11306623|NCT03111108|BG000|Baseline|Arm 1: EBR/GZR for 8 Weeks|Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR FDC (50 mg/100 mg) for 8 weeks, followed by 24 weeks of follow-up.
11306624|NCT03111108|BG001|Baseline|Arm 2: EBR/GZR for 12 Weeks|Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up.
11306625|NCT03111108|BG002|Baseline|Total|Total of all reporting groups
11306626|NCT03111108|FG000|Participant Flow|Arm 1: EBR/GZR for 8 Weeks|Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received elbasvir/grazoprevir (EBR/GZR) fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up.
11306627|NCT03111108|FG001|Participant Flow|Arm 2: EBR/GZR for 12 Weeks|Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up.
11306628|NCT03111108|OG000|Outcome|Arm 1: EBR/GZR for 8 Weeks|Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up.
11306629|NCT03111108|OG001|Outcome|Arm 2: EBR/GZR for 12 Weeks|Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up.
11306630|NCT03111108|EG000|Reported Event|Arm 1: EBR/GZR for 8 Weeks|Treatment-naïve HCV GT4 participants with stage 0-2 fibrosis (F0-F2) received EBR/GZR fixed dose combination (FDC) [50 mg/100 mg] for 8 weeks, followed by 24 weeks of follow-up.
11306631|NCT03111108|EG001|Reported Event|Arm 2: EBR/GZR for 12 Weeks|Treatment-naïve HCV GT4 participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis received EBR/GZR FDC (50 mg/100 mg) for 12 weeks, followed by 24 weeks of follow-up.
11306632|NCT03111316|BG000|Baseline|Nulliparous Foley Catheter & Dinoprostone Insert|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306633|NCT03111316|BG001|Baseline|Nulliparous Foley Catheter Alone|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone
11306634|NCT03111316|BG002|Baseline|Parous Foley Catheter & Dinoprostone Insert|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306635|NCT03111316|BG003|Baseline|Parous Foley Catheter Alone|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
11306636|NCT03111316|BG004|Baseline|Total|Total of all reporting groups
11306637|NCT03111316|FG000|Participant Flow|Nulliparous Foley Catheter & Dinoprostone Insert|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306638|NCT03111316|FG001|Participant Flow|Nulliparous Foley Catheter Alone|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone
11306639|NCT03111316|FG002|Participant Flow|Parous Foley Catheter & Dinoprostone Insert|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306640|NCT03111316|FG003|Participant Flow|Parous Foley Catheter Alone|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
11306641|NCT03111316|OG000|Outcome|Nulliparous Foley Catheter & Dinoprostone Insert|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306642|NCT03111316|OG001|Outcome|Nulliparous Foley Catheter Alone|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone
11306643|NCT03111316|OG002|Outcome|Parous Foley Catheter & Dinoprostone Insert|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306644|NCT03111316|OG003|Outcome|Parous Foley Catheter Alone|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
11306645|NCT03111316|EG000|Reported Event|Nulliparous Foley Catheter & Dinoprostone Insert|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306646|NCT03111316|EG001|Reported Event|Nulliparous Foley Catheter Alone|patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone
11306647|NCT03111316|EG002|Reported Event|Parous Foley Catheter & Dinoprostone Insert|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently
11306648|NCT03111316|EG003|Reported Event|Parous Foley Catheter Alone|patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
11306649|NCT03111381|BG000|Baseline|Intervention Group|"The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents~Toradol: IV toradol"
11306650|NCT03111381|BG001|Baseline|Non-Intervention Group|In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
11306651|NCT03111381|BG002|Baseline|Total|Total of all reporting groups
11306652|NCT03111381|FG000|Participant Flow|Intervention Group|"The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents~Toradol: IV toradol"
11306653|NCT03111381|FG001|Participant Flow|Non-Intervention Group|In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
11306654|NCT03111381|OG000|Outcome|Intervention Group|"The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents~Toradol: IV toradol"
11306655|NCT03111381|OG001|Outcome|Non-Intervention Group|In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
11306656|NCT03111381|EG000|Reported Event|Intervention Group|"The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents~Toradol: IV toradol"
11306657|NCT03111381|EG001|Reported Event|Non-Intervention Group|In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
11306658|NCT03111407|BG000|Baseline|iAssist Group|45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
11306659|NCT03111407|BG001|Baseline|Conventional Instrumentation Group|27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
11306660|NCT03111407|BG002|Baseline|Total|Total of all reporting groups
11306661|NCT03111407|FG000|Participant Flow|iAssist Group|45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
11306662|NCT03111407|FG001|Participant Flow|Conventional Instrumentation Group|27 conventional instrumentation cases have been enrolled in 3 sites between April 2014 and August 2017.
11306663|NCT03111407|OG000|Outcome|iAssist Group|45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
11306664|NCT03111407|OG001|Outcome|Conventional Instrumentation Group|27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
11306665|NCT03111407|OG001|Outcome|Conventional Instrumentation Group|27 conventional instrumentation cases have been enrolled in 3 sites between April 2014 and August 2017.
11306666|NCT03111407|EG000|Reported Event|iAssist Group|45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
11306667|NCT03111407|EG001|Reported Event|Conventional Instrumentation Group|27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
11306668|NCT03111550|BG000|Baseline|Tecnis ZHR00|Investigational Lens Device
11306669|NCT03111550|BG001|Baseline|Tecnis ZQR00|Investigational Lens Device
11306670|NCT03111550|BG002|Baseline|Tecnis ZXR00|Control Lens Device
11306671|NCT03111550|BG003|Baseline|Total|Total of all reporting groups
11306672|NCT03111550|FG000|Participant Flow|Tecnis ZHR00|Investigational Lens Device
11306673|NCT03111550|FG001|Participant Flow|Tecnis ZQR00|Investigational Lens Device
11306674|NCT03111550|FG002|Participant Flow|Tecnis ZXR00|Control Lens Device
11306675|NCT03111550|OG000|Outcome|Tecnis ZHR00|Investigational Lens Device
11306676|NCT03111550|OG001|Outcome|Tecnis ZQR00|Investigational Lens Device
11306677|NCT03111550|OG002|Outcome|Tecnis ZXR00|Control Lens Device
11306678|NCT03111550|EG000|Reported Event|Tecnis ZHR00|Investigational Lens Device
11306679|NCT03111550|EG001|Reported Event|ZQR00|Investigational Lens Device
11306680|NCT03111550|EG002|Reported Event|ZXR00|Control Lens Device
11306681|NCT03111628|BG000|Baseline|Omalizumab|"Omalizumab 300mg every month for 3 doses~Omalizumab: omalizumab 300 mg every 4 weeks by subcutaneous injection"
11306682|NCT03111628|FG000|Participant Flow|Omalizumab|"Omalizumab 300mg every month for 3 doses~Omalizumab: omalizumab 300 mg every 4 weeks by subcutaneous injection"
11306683|NCT03111628|OG000|Outcome|Basopenics|Subjects with blood basophils less than 8000/ml good
11306684|NCT03111628|OG001|Outcome|Non-basopenic|Subjects with > 8000 basophils/ml
11306685|NCT03111628|EG000|Reported Event|Omalizumab|"Omalizumab 300mg every month for 3 doses~Omalizumab: omalizumab 300 mg every 4 weeks by subcutaneous injection"
11306686|NCT03111940|BG000|Baseline|Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI|In patients in Group 1, OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the CLI-OPCI study defining a suboptimal stent result according to specific criteria. For patients that fulfilled OCT criteria for optimisation (Group 1A), operators were mandated to perform PCI optimisation according to the respective OCT finding. For patients in Group 1 who did not fulfil the OCT criteria (Group 1B), further PCI optimisation was not performed.
11306687|NCT03111940|BG001|Baseline|Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI|For patients in Group 2, no further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications.
11306688|NCT03111940|BG002|Baseline|Total|Total of all reporting groups
11306689|NCT03111940|FG000|Participant Flow|Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI|OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the presence of one or more of the following according to CLI-OPCI study criteria: stent underexpansion and/or incomplete lesion coverage and/or stent malapposition and/or stent-edge dissection and/or intra-stent plaque/thrombus protrusion. Operators were mandated to perform PCI optimisation according to the respective OCT finding.
11306690|NCT03111940|FG001|Participant Flow|Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI|No further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications
11306691|NCT03111940|OG000|Outcome|Group 1A: OCT-guided PCI Optimisation|Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
11306692|NCT03111940|OG001|Outcome|Group 1B: No PCI Optimisation Performed|Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
11306693|NCT03111940|OG000|Outcome|Group 1A: Post-stenting FFR Below 0.9, FFR/OCT Optimisation Performed|OCT fulfilled optimisation criteria Presence of one or more of the following criteria for optimisation: stent underexpansion and/or incomplete lesion coverage and/or stent malapposition and/or stent-edge dissection and/or intra-stent plaque/thrombus protrusion.
11306694|NCT03111940|OG001|Outcome|Group 2: Post-stenting FFR 0.9 or Higher|No further PCI optimisation performed and OCT acquisition performed only as safety measure to assess frequency of relevant vessel-related complications
11306695|NCT03111940|EG000|Reported Event|PCI Optimisation|"Post PCI FFR below 0.9~Optimisation of the result of intracoronary stenting according to specific algorithm"
11306696|NCT03111940|EG001|Reported Event|No PCI Optimisation|Post PCI FFR 0.9 or higher
11306697|NCT03112473|BG000|Baseline|Bilateral TENS (Bi-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 7 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
11306698|NCT03112473|BG001|Baseline|Unilateral TENS (Uni-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 7 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side
11306699|NCT03112473|BG002|Baseline|Placebo Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 7 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
11306700|NCT03112473|BG003|Baseline|Control Group|No Active intervention
11306701|NCT03112473|BG004|Baseline|Total|Total of all reporting groups
11306702|NCT03112473|FG000|Participant Flow|Bilateral TENS (Bi-TENS) Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation~Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb~Transcutaneous electrical nerve stimulation (TENS)"
11306703|NCT03112473|FG001|Participant Flow|Unilateral TENS (Uni-TENS) Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side~Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb~Transcutaneous electrical nerve stimulation (TENS)"
11306704|NCT03112473|FG002|Participant Flow|Placebo Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation~Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb~Sham electrical nerve stimulation"
11306705|NCT03112473|FG003|Participant Flow|Control Group|No Active intervention
11306706|NCT03112473|OG000|Outcome|Bilateral TENS (Bi-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
11306707|NCT03112473|OG001|Outcome|Unilateral TENS (Uni-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side
11306708|NCT03112473|OG002|Outcome|Placebo Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
11306709|NCT03112473|OG003|Outcome|Control Group|No Active intervention
11306710|NCT03112473|OG000|Outcome|Bilateral TENS (Bi-TENS) Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation~Task-orientated training: Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.~Transcutaneous electrical nerve stimulation (TENS): The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan). The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study"
11306711|NCT03112473|OG001|Outcome|Unilateral TENS (Uni-TENS) Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side~Task-orientated training: Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.~Transcutaneous electrical nerve stimulation (TENS): The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan). The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study~Sham electrical nerve stimulation: A identical-looking TENS devices that electrical circuit has been disconnected."
11306712|NCT03112473|OG002|Outcome|Placebo Group|"All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation~Task-orientated training: Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.~Sham electrical nerve stimulation: A identical-looking TENS devices that electrical circuit has been disconnected."
11306713|NCT03112473|EG000|Reported Event|Bilateral TENS (Bi-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
11306714|NCT03112473|EG001|Reported Event|Unilateral TENS (Uni-TENS) Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side
11306715|NCT03112473|EG002|Reported Event|Placebo Group|All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
11306716|NCT03112473|EG003|Reported Event|Control Group|No Active intervention
11306717|NCT03112863|BG000|Baseline|Bakuchiol|"Bakuchiol 0.5% applied to face twice daily~Bakuchiol: This group will receive bakuchiol"
11306718|NCT03112863|BG001|Baseline|Retinol|"0.5% retinol applied to face nightly~Retinol: This group will receive retinol"
11306719|NCT03112863|BG002|Baseline|Total|Total of all reporting groups
11306720|NCT03112863|FG000|Participant Flow|Bakuchiol|"Bakuchiol 0.5% applied to face twice daily~Bakuchiol: This group will receive bakuchiol"
10822269|NCT00075725|BG011|Baseline|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
10822270|NCT00075725|BG012|Baseline|Total|Total of all reporting groups
11306721|NCT03112863|FG001|Participant Flow|Retinol|"0.5% retinol applied to face nightly~Retinol: This group will receive retinol"
11306722|NCT03112863|OG000|Outcome|Bakuchiol|"Bakuchiol 0.5% applied to face twice daily~Bakuchiol: This group will receive bakuchiol"
11306723|NCT03112863|OG001|Outcome|Retinol|"0.5% retinol applied to face nightly~Retinol: This group will receive retinol"
11306724|NCT03112863|EG000|Reported Event|Bakuchiol|"Bakuchiol 0.5% applied to face twice daily~Bakuchiol: This group will receive bakuchiol"
11306725|NCT03112863|EG001|Reported Event|Retinol|"0.5% retinol applied to face nightly~Retinol: This group will receive retinol"
11306726|NCT03113656|BG000|Baseline|Weighted Blanket First|"This group will receive the Weighted Blanket first and then the Non-weighted blanket~Weighted Blanket: Weighted blanket placed on infant for 30 minutes~Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes"
11306727|NCT03113656|BG001|Baseline|Non-weighted Blanket First|"This group will receive the Non-weighted Blanket first and then the Weighted blanket~Weighted Blanket: Weighted blanket placed on infant for 30 minutes~Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes"
11306728|NCT03113656|BG002|Baseline|Total|Total of all reporting groups
11306729|NCT03113656|FG000|Participant Flow|Weighted Blanket First|"This group will receive the Weighted Blanket first and then the Non-weighted blanket~Weighted Blanket: Weighted blanket placed on infant for 30 minutes~Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes"
11306730|NCT03113656|FG001|Participant Flow|Non-weighted Blanket First|"This group will receive the Non-weighted Blanket first and then the Weighted blanket~Weighted Blanket: Weighted blanket placed on infant for 30 minutes~Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes"
11306731|NCT03113656|OG000|Outcome|Intervention|Weighted Blanket: Weighted blanket placed on infant for 30 minutes
11306732|NCT03113656|OG001|Outcome|Control|Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes
11306733|NCT03113656|EG000|Reported Event|Intervention|Weighted Blanket: Weighted blanket placed on infant for 30 minutes
11306734|NCT03113656|EG001|Reported Event|Control|Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes
11306735|NCT03113916|BG000|Baseline|Behavioral|"26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change~Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention."
11306736|NCT03113916|BG001|Baseline|Enhanced Usual Care|Printed materials
11306737|NCT03113916|BG002|Baseline|Total|Total of all reporting groups
11306738|NCT03113916|FG000|Participant Flow|Behavioral Intervention|"26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change~Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention."
11306739|NCT03113916|FG001|Participant Flow|Enhanced Usual Care|Printed materials and usual medical care
11306740|NCT03113916|OG000|Outcome|Behavioral|"26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change~Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention."
11306741|NCT03113916|OG001|Outcome|Enhanced Usual Care|Printed materials
11306742|NCT03113916|OG000|Outcome|Behavioral|Intervention
11306743|NCT03113916|OG001|Outcome|Enhanced Usual Care|Control
11306744|NCT03113916|OG000|Outcome|Behavioral Intervention|"26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change~Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention."
11306745|NCT03113916|OG001|Outcome|Enhanced Usual Care|Printed materials and usual medical care
11306746|NCT03113916|OG000|Outcome|Sustainability Phase Participants|Participants recruited into sustainability groups
11306747|NCT03113916|EG000|Reported Event|Behavioral|"26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change~Behavioural Lifestyle Intervention: A culturally tailored behavioral intervention."
11306748|NCT03113916|EG001|Reported Event|Enhanced Usual Care|Printed materials
11306749|NCT03114124|BG000|Baseline|Bipolar Ablation Catheter|"Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.~Standard Ablation Catheter: Standard of care for patients with certain cardiac arrhythmias."
11306750|NCT03114124|BG001|Baseline|MIFI Ablation Catheter|"Subjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern~MIFI Catheter: Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity"
11306751|NCT03114124|BG002|Baseline|Total|Total of all reporting groups
11306752|NCT03114124|FG000|Participant Flow|Bipolar Ablation Catheter|"Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.~Standard Ablation Catheter: Standard of care for patients with certain cardiac arrhythmias."
11306753|NCT03114124|FG001|Participant Flow|MIFI Ablation Catheter|"Subjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern~MIFI Catheter: Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity"
11306754|NCT03114124|OG000|Outcome|Bipolar Ablation Catheter|"Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.~Standard Ablation Catheter: Standard of care for patients with certain cardiac arrhythmias."
11306755|NCT03114124|OG001|Outcome|MIFI Ablation Catheter|"Subjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern~MIFI Catheter: Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity"
11306756|NCT03114124|EG000|Reported Event|Bipolar Ablation Catheter|"Subjects will be randomized by random computer programming to receive standard ablation catheter for their procedure.~Standard Ablation Catheter: Standard of care for patients with certain cardiac arrhythmias."
11306757|NCT03114124|EG001|Reported Event|MIFI Ablation Catheter|"Subjects will be randomized by random computer programming to receive an ablation with MIFI technology. MIFI Catheter contains tightly spaced multielectrode pattern~MIFI Catheter: Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity"
11306758|NCT03114488|BG000|Baseline|All Participants|Crossover Design: All participants are included in baseline analysis.
11306759|NCT03114488|FG000|Participant Flow|Active tDCS First, Then Sham|Participants randomized to active tDCS first, then the sham treatment
11306760|NCT03114488|FG001|Participant Flow|Sham tDCS First, Then Active|Participants randomized to sham tDCS first, then the active treatment
11306761|NCT03114488|OG000|Outcome|Anodal Stimulation - Time Period 1|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, experimental stimulation arm - time period 1"
11306762|NCT03114488|OG001|Outcome|Sham Stimulation - Time Period 1|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, sham stimulation arm - time period 1"
11306763|NCT03114488|OG002|Outcome|Anodal Stimulation - Time Period 2|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, experimental stimulation arm - time period 2"
11306764|NCT03114488|OG003|Outcome|Sham Stimulation - Time Period 2|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, sham stimulation arm - time period 2"
11306765|NCT03114488|EG000|Reported Event|Anodal Stimulation - Time Period 1|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, experimental stimulation arm - time period 1"
11306766|NCT03114488|EG001|Reported Event|Sham Stimulation - Time Period 1|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, sham stimulation arm - time period 1"
11306767|NCT03114488|EG002|Reported Event|Anodal Stimulation - Time Period 2|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, experimental stimulation arm - time period 2"
11306768|NCT03114488|EG003|Reported Event|Sham Stimulation - Time Period 2|"Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential~Crossover design, sham stimulation arm - time period 2"
11306769|NCT03114657|BG000|Baseline|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11306770|NCT03114657|BG001|Baseline|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11306771|NCT03114657|BG002|Baseline|Total|Total of all reporting groups
11306772|NCT03114657|FG000|Participant Flow|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11306773|NCT03114657|FG001|Participant Flow|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11306774|NCT03114657|OG000|Outcome|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11306775|NCT03114657|OG001|Outcome|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11306776|NCT03114657|OG000|Outcome|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11306777|NCT03114657|EG000|Reported Event|Placebo|Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
11306778|NCT03114657|EG001|Reported Event|Crenezumab|Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
11306779|NCT03114683|BG000|Baseline|Sintilimab|Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
11306780|NCT03114683|FG000|Participant Flow|Sintilimab|Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
11306781|NCT03114683|OG000|Outcome|Sintilimab|Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
11306782|NCT03114683|EG000|Reported Event|Sintilimab|Subjects received sintilimab 200mg by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 2 years
11306783|NCT03114969|BG000|Baseline|Relvar Ellipta|Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
11306784|NCT03114969|BG001|Baseline|Symbicort Turbuhaler|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
11306785|NCT03114969|BG002|Baseline|Seretide Diskus|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
11306786|NCT03114969|BG003|Baseline|Spiriva Handihaler|Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
11306787|NCT03114969|BG004|Baseline|Incruse/Anoro Ellipta|Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
11306788|NCT03114969|BG005|Baseline|Ultibro/Seebri Breezhaler|Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
11306789|NCT03114969|BG006|Baseline|Relvar Ellipta+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306790|NCT03114969|BG007|Baseline|Symbicort Turbuhaler+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306791|NCT03114969|BG008|Baseline|Seretide Diskus+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306792|NCT03114969|BG009|Baseline|Total|Total of all reporting groups
11306793|NCT03114969|FG000|Participant Flow|Relvar Ellipta|Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
11306794|NCT03114969|FG001|Participant Flow|Symbicort Turbuhaler|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
11306795|NCT03114969|FG002|Participant Flow|Seretide Diskus|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
11306796|NCT03114969|FG003|Participant Flow|Spiriva Handihaler|Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
11306797|NCT03114969|FG004|Participant Flow|Incruse/Anoro Ellipta|Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
11306798|NCT03114969|FG005|Participant Flow|Ultibro/Seebri Breezhaler|Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
11306799|NCT03114969|FG006|Participant Flow|Relvar Ellipta+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306800|NCT03114969|FG007|Participant Flow|Symbicort Turbuhaler+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306801|NCT03114969|FG008|Participant Flow|Seretide Diskus+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306802|NCT03114969|OG000|Outcome|Relvar Ellipta|Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
11306803|NCT03114969|OG001|Outcome|Symbicort Turbuhaler|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
11306804|NCT03114969|OG002|Outcome|Seretide Diskus|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
10971988|NCT00918723|FG000|Participant Flow|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10971989|NCT00918723|OG000|Outcome|MTD for Vorinostat During Induction Therapy|"MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10971990|NCT00918723|OG001|Outcome|MTD for Vorinostat During Maintenance Therapy|"MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.~Rituximab: Given IV~Vorinostat: Given PO"
10971991|NCT00918723|OG000|Outcome|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10971992|NCT00918723|EG000|Reported Event|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
10971993|NCT00918736|BG000|Baseline|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
10971994|NCT00918736|FG000|Participant Flow|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
10971995|NCT00918736|OG000|Outcome|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
10971996|NCT00918736|EG000|Reported Event|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
10971997|NCT00918749|BG000|Baseline|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
10971998|NCT00918749|BG001|Baseline|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10971999|NCT00918749|BG002|Baseline|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972000|NCT00918749|BG003|Baseline|Total|Total of all reporting groups
10972001|NCT00918749|FG000|Participant Flow|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
10972002|NCT00918749|FG001|Participant Flow|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972003|NCT00918749|FG002|Participant Flow|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972004|NCT00918749|OG000|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
10972005|NCT00918749|OG001|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972006|NCT00918749|OG002|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972007|NCT00918749|EG000|Reported Event|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
10972008|NCT00918749|EG001|Reported Event|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972009|NCT00918749|EG002|Reported Event|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
10972010|NCT00918866|BG000|Baseline|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
10972011|NCT00918866|BG001|Baseline|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
10972012|NCT00918866|BG002|Baseline|Total|Total of all reporting groups
10972013|NCT00918866|FG000|Participant Flow|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
10972014|NCT00918866|FG001|Participant Flow|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
11306805|NCT03114969|OG003|Outcome|Spiriva Handihaler|Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
11306806|NCT03114969|OG004|Outcome|Incruse/Anoro Ellipta|Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
11306807|NCT03114969|OG005|Outcome|Ultibro/Seebri Breezhaler|Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
11306808|NCT03114969|OG006|Outcome|Relvar Ellipta+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306809|NCT03114969|OG007|Outcome|Symbicort Turbuhaler+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306810|NCT03114969|OG008|Outcome|Seretide Diskus+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306811|NCT03114969|OG000|Outcome|[Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]|All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
11306812|NCT03114969|OG001|Outcome|Relvar Ellipta|Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
11306813|NCT03114969|OG000|Outcome|Relvar Ellipta+[Relvar Ellipta+LAMA]|All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
11306814|NCT03114969|OG001|Outcome|Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]|All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
11306815|NCT03114969|OG002|Outcome|Seretide Diskus+[Seretide Diskus+LAMA]|All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
11306816|NCT03114969|OG001|Outcome|Relvar Ellipta+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306817|NCT03114969|OG001|Outcome|[Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]|All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
11306818|NCT03114969|EG000|Reported Event|Relvar Ellipta|Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
11306819|NCT03114969|EG001|Reported Event|Symbicort Turbuhaler|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
11306820|NCT03114969|EG002|Reported Event|Seretide Diskus|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
11306821|NCT03114969|EG003|Reported Event|Spiriva Handihaler|Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
11306822|NCT03114969|EG004|Reported Event|Incruse/Anoro Ellipta|Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
11306823|NCT03114969|EG005|Reported Event|Ultibro/Seebri Breezhaler|Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
11306824|NCT03114969|EG006|Reported Event|Relvar Ellipta+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306825|NCT03114969|EG007|Reported Event|Symbicort Turbuhaler+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306826|NCT03114969|EG008|Reported Event|Seretide Diskus+LAMA|Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
11306827|NCT03114995|BG000|Baseline|Group A (High Platelet Reactivity - Tirofiban)|"Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h~Tirofiban"
11306828|NCT03114995|BG001|Baseline|Control C1 (High Platelet Reactivity - no Tirofiban)|Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
11306829|NCT03114995|BG002|Baseline|Control C2 (Low Platelet Reactivity - no Tirofiban)|Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
11306830|NCT03114995|BG003|Baseline|Total|Total of all reporting groups
11306831|NCT03114995|FG000|Participant Flow|Group A (High Platelet Reactivity - Tirofiban)|"Patients with high platelet reactivity (HPR) unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h~Tirofiban"
11306832|NCT03114995|FG001|Participant Flow|Control C1 (High Platelet Reactivity - no Tirofiban)|Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
11306833|NCT03114995|FG002|Participant Flow|Control C2(Low Platelet Reactivity - no Tirofiban)|Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
11306834|NCT03114995|OG000|Outcome|Group A (High Platelet Reactivity - Tirofiban)|"Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h~Tirofiban"
11306835|NCT03114995|OG001|Outcome|Control C1 (High Platelet Reactivity - no Tirofiban)|Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
11306836|NCT03114995|OG002|Outcome|Control C2 (Low Platelet Reactivity - no Tirofiban)|Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
11306837|NCT03114995|EG000|Reported Event|Group A (High Platelet Reactivity - Tirofiban)|"Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h~Tirofiban"
11306838|NCT03114995|EG001|Reported Event|Control C1 (High Platelet Reactivity - no Tirofiban)|Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
10848508|NCT00290238|FG000|Participant Flow|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
11306839|NCT03114995|EG002|Reported Event|Control C2 (Low Platelet Reactivity - no Tirofiban)|Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
11306840|NCT03115112|BG000|Baseline|Bexagliflozin|Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study.
11306841|NCT03115112|BG001|Baseline|Sitagliptin|Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
11306842|NCT03115112|BG002|Baseline|Total|Total of all reporting groups
11306843|NCT03115112|FG000|Participant Flow|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study.~Bexagliflozin: 20 mg, tablet~Placebo for sitagliptin: 100 mg inactive tablet to match active comparator"
10848509|NCT00290238|FG001|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
11306844|NCT03115112|FG001|Participant Flow|Sitagliptin|"Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Sitagliptin: 100 mg, tablet~Placebo for bexagliflozin: 20 mg inactive tablet to match active comparator"
11306845|NCT03115112|OG000|Outcome|Bexagliflozin|"Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study.~Bexagliflozin: 20 mg, tablet~Placebo for sitagliptin: 100 mg inactive tablet to match active comparator"
11306846|NCT03115112|OG001|Outcome|Sitagliptin|"Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.~Sitagliptin: 100 mg, tablet~Placebo for bexagliflozin: 20 mg inactive tablet to match active comparator"
11306847|NCT03115112|OG000|Outcome|Bexagliflozin|"Subjects received a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects continued taking metformin and received placebo for sitagliptin daily for the duration of the study.~Bexagliflozin: 20 mg, tablet~Placebo for sitagliptin: 100 mg inactive tablet to match active comparator"
11306848|NCT03115112|OG001|Outcome|Sitagliptin|"Subjects received a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects continued taking metformin and received placebo for bexagliflozin for the duration of the study.~Sitagliptin: 100 mg, tablet~Placebo for bexagliflozin: 20 mg inactive tablet to match active comparator"
11306849|NCT03115112|EG000|Reported Event|Bexagliflozin|Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study.
11306850|NCT03115112|EG001|Reported Event|Sitagliptin|Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
11306851|NCT03115177|BG000|Baseline|Cefazolin|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment.~Cefazolin"
11306852|NCT03115177|BG001|Baseline|Doxycycline+Cefazolin Group|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.~Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.~Cefazolin"
11306853|NCT03115177|BG002|Baseline|Total|Total of all reporting groups
11306854|NCT03115177|FG000|Participant Flow|Cefazolin|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment.~Cefazolin"
11306855|NCT03115177|FG001|Participant Flow|Cefazolin and Doxycycline|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.~Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.~Cefazolin"
11306856|NCT03115177|OG000|Outcome|Cefazolin|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment.~Cefazolin"
11306857|NCT03115177|OG001|Outcome|Cefazolin and Doxycycline|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.~Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.~Cefazolin"
11306858|NCT03115177|EG000|Reported Event|Control|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment.~Cefazolin"
11306859|NCT03115177|EG001|Reported Event|Treatment|"All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.~Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.~Cefazolin"
11306860|NCT03115411|BG000|Baseline|Winged Stent|Single arm study (winged biliary stent)
11306861|NCT03115411|FG000|Participant Flow|Winged Biliary Stent|"Typical biliary stents have a circular, straw-like lumen. Recently, a stent with a star-shaped cross-section and no central lumen has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.~The stent which is star shaped in cross section, channels fluid along its winged perimeter. It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents.~in this arm, we utilize the biliary wing stent in standard clinical settings (biliary obstruction) and assess patency"
11306862|NCT03115411|OG000|Outcome|Winged Stent|Single arm study (winged biliary stent)
11306863|NCT03115411|EG000|Reported Event|Winged Stent|Single arm study (winged biliary stent)
11306864|NCT03115476|BG000|Baseline|Ingenol Disoxate Gel 0.018%|ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306865|NCT03115476|BG001|Baseline|Ingenol Disoxate Gel 0.037%|ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306866|NCT03115476|BG002|Baseline|Vehicle Gel|Vehicle gel of ingenol disoxate gel
11306867|NCT03115476|BG003|Baseline|Total|Total of all reporting groups
11306868|NCT03115476|FG000|Participant Flow|Ingenol Disoxate Gel 0.018%|ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses (AKs) on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306869|NCT03115476|FG001|Participant Flow|Ingenol Disoxate Gel 0.037%|ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306870|NCT03115476|FG002|Participant Flow|Vehicle Gel|Vehicle gel to Ingenol disoxate gel with no active ingredient
11306871|NCT03115476|OG000|Outcome|Ingenol Disoxate Gel 0.018%|ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306872|NCT03115476|OG001|Outcome|Ingenol Disoxate Gel 0.037%|ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306873|NCT03115476|OG002|Outcome|Vehicle Gel|Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306874|NCT03115476|EG000|Reported Event|Ingenol Disoxate Gel 0.018%|ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306875|NCT03115476|EG001|Reported Event|Ingenol Disoxate Gel 0.037%|ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306876|NCT03115476|EG002|Reported Event|Vehicle Gel|Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
11306877|NCT03115580|BG000|Baseline|Rotational Atherectomy|"Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the snow plow effect."
11306878|NCT03115580|BG001|Baseline|CBA/PTCA|"Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)~Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon"
11306879|NCT03115580|BG002|Baseline|Total|Total of all reporting groups
11306880|NCT03115580|FG000|Participant Flow|Rotational Atherectomy|"Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the snow plow effect."
11306881|NCT03115580|FG001|Participant Flow|CBA/PTCA|"Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)~Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon"
11306882|NCT03115580|OG000|Outcome|Rotational Atherectomy|"Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the snow plow effect."
11306883|NCT03115580|OG001|Outcome|CBA/PTCA|"Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)~Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon"
11306884|NCT03115580|EG000|Reported Event|Rotational Atherectomy|"Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the snow plow effect."
11306885|NCT03115580|EG001|Reported Event|CBA/PTCA|"Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)~Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon"
11306886|NCT03115801|BG000|Baseline|Arm A - Immunotherapy Alone|"Patients with Renal Cell carcinoma will receive Nivolumab alone Days 1, 15, 29, 43 and 57.~Patients with Urothelial cancer will receive Atezolizumab or Pembrolizumab on Days 1, 22, 43 and 64.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Pembrolizumab: Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64."
11306887|NCT03115801|BG001|Baseline|Arm B - Radiation & Immunotherapy|"Radiation is given to one lesion, 30 Gy in 3 fractions of 10 Gy, every other day. On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Radiation & immunotherapy: Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1."
11306888|NCT03115801|BG002|Baseline|Total|Total of all reporting groups
11306889|NCT03115801|FG000|Participant Flow|Arm A - Immunotherapy Alone|"Patients with Renal Cell carcinoma will receive Nivolumab alone Days 1, 15, 29, 43 and 57.~Patients with Urothelial cancer will receive Atezolizumab or Pembrolizumab on Days 1, 22, 43 and 64.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Pembrolizumab: Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64."
11306890|NCT03115801|FG001|Participant Flow|Arm B - Radiation & Immunotherapy|"Radiation is given to one lesion, 30 Gy in 3 fractions of 10 Gy, every other day. On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Radiation & immunotherapy: Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1."
11306891|NCT03115801|OG000|Outcome|Arm A - Immunotherapy Alone|"Patients with Renal Cell carcinoma will receive Nivolumab alone Days 1, 15, 29, 43 and 57.~Patients with Urothelial cancer will receive Atezolizumab or Pembrolizumab on Days 1, 22, 43 and 64.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Pembrolizumab: Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64."
11306892|NCT03115801|OG001|Outcome|Arm B - Radiation & Immunotherapy|"Radiation is given to one lesion, 30 Gy in 3 fractions of 10 Gy, every other day. On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Radiation & immunotherapy: Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1."
11306893|NCT03115801|EG000|Reported Event|Arm A - Immunotherapy Alone|"Patients with Renal Cell carcinoma will receive Nivolumab alone Days 1, 15, 29, 43 and 57.~Patients with Urothelial cancer will receive Atezolizumab or Pembrolizumab on Days 1, 22, 43 and 64.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Pembrolizumab: Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64."
11306894|NCT03115801|EG001|Reported Event|Arm B - Radiation & Immunotherapy|"Radiation is given to one lesion, 30 Gy in 3 fractions of 10 Gy, every other day. On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days.~Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.~Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.~Radiation & immunotherapy: Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1."
11306895|NCT03115827|BG000|Baseline|Arm 1|"Droxidopa 600mg by mouth twice a day and carbidopa 200mg by mouth twice a day for 4 weeks~Droxidopa: Droxidopa will be started at 100mg twice a day and titrated up to a maximum of 600mg twice a day~Carbidopa: Carbidopa 200mg twice a day"
11306896|NCT03115827|FG000|Participant Flow|Arm 1|"Droxidopa 600mg by mouth twice a day and carbidopa 200mg by mouth twice a day for 4 weeks~Droxidopa: Droxidopa will be started at 100mg twice a day and titrated up to a maximum of 600mg twice a day~Carbidopa: Carbidopa 200mg twice a day"
11306897|NCT03115827|OG000|Outcome|Arm 1|"Droxidopa 600mg by mouth twice a day and carbidopa 200mg by mouth twice a day for 4 weeks~Droxidopa: Droxidopa will be started at 100mg twice a day and titrated up to a maximum of 600mg twice a day~Carbidopa: Carbidopa 200mg twice a day"
11306898|NCT03115827|EG000|Reported Event|Arm 1|"Droxidopa 600mg by mouth twice a day and carbidopa 200mg by mouth twice a day for 4 weeks~Droxidopa: Droxidopa will be started at 100mg twice a day and titrated up to a maximum of 600mg twice a day~Carbidopa: Carbidopa 200mg twice a day"
11306899|NCT03116152|BG000|Baseline|Sintilimab|Sintilimab (IBI308) 200mg Intravenous drip every three weeks
11306900|NCT03116152|BG001|Baseline|Chemotherapy|paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
11306901|NCT03116152|BG002|Baseline|Total|Total of all reporting groups
11306902|NCT03116152|FG000|Participant Flow|Sintilimab|Sintilimab (IBI308) 200mg Intravenous drip every three weeks
11306903|NCT03116152|FG001|Participant Flow|Chemotherapy|paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
11306904|NCT03116152|OG000|Outcome|Sintilimab|Sintilimab (IBI308) 200mg Intravenous drip every three weeks
11306905|NCT03116152|OG001|Outcome|Chemotherapy|paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
11306906|NCT03116152|OG000|Outcome|Sintilimab|Sintilimab (IBI308) 200mg intravenous drip every three weeks
11306907|NCT03116152|OG001|Outcome|Chemotherapy|paclitaxel 175mg/㎡ intravenous drip every three weeks； irinotecan 180mg/㎡ intravenous drip every two weeks
11306908|NCT03116152|EG000|Reported Event|Sintilimab|Sintilimab (IBI308) 200mg Intravenous drip every three weeks
11306909|NCT03116152|EG001|Reported Event|Chemotherapy|paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
11337709|NCT03591406|OG001|Outcome|Iron Sucrose (IS)|"Participants treated with IS given by IV injection or drip infusion~Dosage Form: Sterile solution for injection containing 2% w/v iron~Strength: 5 mL ampoules containing 100 mg iron per ampoule~Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given~Route of administration: IV injection or drip infusion~Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose."
11306910|NCT03116230|BG000|Baseline|All Participants|"Subjects received two treatments assigned in random order: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.~Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.~Knee Sleeve: Commercially-available knee sleeve."
11306911|NCT03116230|FG000|Participant Flow|Experimental Treatment A Then B|"Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period.~Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.~Knee Sleeve: Commercially-available Passive Knee Bands."
11306912|NCT03116230|FG001|Participant Flow|Experimental Treatment B Then A|"Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.~Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.~Knee Sleeve: Commercially-available knee sleeve."
11306913|NCT03116230|OG000|Outcome|Treatment A (Cutaneous Stimulation)|Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
11306914|NCT03116230|OG001|Outcome|Treatment B (Knee Sleeve)|Knee Sleeve: Commercially-available Passive Knee Bands.
11306915|NCT03116230|EG000|Reported Event|Treatment A (Cutaneous Stimulation)|Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
11306916|NCT03116230|EG001|Reported Event|Treatment B (Knee Sleeve)|Knee Sleeve: Commercially-available Passive Knee Bands.
11306917|NCT03116698|BG000|Baseline|DFD07 Cream 1.25% Once Daily|"DFD07 Cream (celecoxib 1.25%) once daily:~The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 1.25%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups."
11306918|NCT03116698|BG001|Baseline|DFD07 Cream 2.5% Once Daily|"DFD07 Cream (celecoxib 2.5%) once daily:~The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 2.5%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups."
11306919|NCT03116698|BG002|Baseline|DFD07 Cream 2.5% Twice Daily|"DFD07 Cream (celecoxib 2.5%) twice daily:~The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment."
11306920|NCT03116698|BG003|Baseline|Vehicle Cream Twice Daily|"Vehicle Cream (celecoxib 0%) twice daily:~The Vehicle Cream was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment."
11306921|NCT03116698|BG004|Baseline|Total|Total of all reporting groups
11306922|NCT03116698|FG000|Participant Flow|DFD07 - 1.25% Once Daily|"Low dose DFD07 (1.25%) once daily:~The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups."
11306923|NCT03116698|FG001|Participant Flow|DFD07 - 2.5% Once Daily|"High dose DFD07 (2.5%) once daily:~The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups."
11306924|NCT03116698|FG002|Participant Flow|DFD07 - 2.5% Twice Daily|High dose DFD07 (2.5%) twice daily: The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.
11306925|NCT03116698|FG003|Participant Flow|Vehicle Twice Daily|"Vehicle twice daily:~The Vehicle product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the Vehicle product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day."
11306926|NCT03116698|OG000|Outcome|DFD07 Cream (Celecoxib 1.25%) Once Daily|DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.
11306927|NCT03116698|OG001|Outcome|DFD07 Cream (Celecoxib 2.5%) Once Daily|DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.
11306928|NCT03116698|OG002|Outcome|DFD07 Cream (Celecoxib 2.5%) Twice Daily|DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
11306929|NCT03116698|OG003|Outcome|Vehicle Cream (Celecoxib 0%) Twice Daily|Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
11306930|NCT03116698|EG000|Reported Event|DFD07 Cream (Celecoxib 1.25%) Once Daily|DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.
11306931|NCT03116698|EG001|Reported Event|DFD07 Cream (Celecoxib 2.5%) Once Daily|DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.
11306932|NCT03116698|EG002|Reported Event|DFD07 Cream (Celecoxib 2.5%) Twice Daily|DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
11306933|NCT03116698|EG003|Reported Event|Vehicle Cream (Celecoxib 0%) Twice Daily|Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
11306934|NCT03116828|BG000|Baseline|Arm 1|(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
11306935|NCT03116828|BG001|Baseline|Arm 2|(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
11306936|NCT03116828|BG002|Baseline|Total|Total of all reporting groups
11306937|NCT03116828|FG000|Participant Flow|Arm 1|(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
11306938|NCT03116828|FG001|Participant Flow|Arm 2|(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
11306939|NCT03116828|OG000|Outcome|Eslicarbazepine Acetate (Arm 1)|eslicarbazepine acetate (ESL) (as first add-on to Levetiracetam or Lamotrigine)
10972015|NCT00918866|OG000|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
11306940|NCT03116828|OG001|Outcome|Eslicarbazepine Acetate (Arm 2)|eslicarbazepine acetate (ESL) (as later add-on to 1-2 Anti-epileptic drugs (AEDs)
11306941|NCT03116828|EG000|Reported Event|Arm 1|(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
11306942|NCT03116828|EG001|Reported Event|Arm 2|(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
11306943|NCT03116841|BG000|Baseline|Vonoprazan 20mg|Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
11306944|NCT03116841|FG000|Participant Flow|Vonoprazan 20mg|Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
11306945|NCT03116841|OG000|Outcome|Vonoprazan 20mg|Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
11306946|NCT03116841|EG000|Reported Event|Vonoprazan 20mg|Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
11306947|NCT03117140|BG000|Baseline|Plain Ropivacaine|"Plain ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block"
11306948|NCT03117140|BG001|Baseline|Ropivacaine + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block"
11306949|NCT03117140|BG002|Baseline|Ropivacaine + Clonidine|"A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block"
11306950|NCT03117140|BG003|Baseline|Ropivacaine + Dexamethasone|"A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block"
11306951|NCT03117140|BG004|Baseline|Total|Total of all reporting groups
11306952|NCT03117140|FG000|Participant Flow|Plain Ropiviciane|"Plain Ropivicaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively~Ropivicaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block"
11306953|NCT03117140|FG001|Participant Flow|Ropiviciane + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivicaine 0.75% + 300 mcg Buprenorphine: Ropivicaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block"
11306954|NCT03117140|FG002|Participant Flow|Ropivicaine + Clonidine|"A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively~Ropivicaine 0.75% + 75 mcg clonidine: Ropivicaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block"
11306955|NCT03117140|FG003|Participant Flow|Ropiviciane + Dexamethasone|"A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively~Ropivicaine 0.75% + 8 mg dexamethasone: Ropivicaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block"
11306956|NCT03117140|OG000|Outcome|Plain Ropivacaine|"Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block"
11306957|NCT03117140|OG001|Outcome|Ropivacaine + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block"
11306958|NCT03117140|OG002|Outcome|Ropivacaine + Clonidine|"A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block"
11306959|NCT03117140|OG003|Outcome|Ropivacaine + Dexamethasone|"A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block"
11306960|NCT03117140|OG001|Outcome|Ropivacaine + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block"
11306961|NCT03117140|OG001|Outcome|Ropivacaine + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block"
11306962|NCT03117140|OG000|Outcome|Plain Ropivacaine|"Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block"
11306963|NCT03117140|EG000|Reported Event|Plain Ropivacaine|"Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block"
11306964|NCT03117140|EG001|Reported Event|Ropivacaine + Buprenorphine|"A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block"
11306965|NCT03117140|EG002|Reported Event|Ropivacaine + Clonidine|"A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block"
11306966|NCT03117140|EG003|Reported Event|Ropivacaine + Dexamethasone|"A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively~Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block"
11306967|NCT03117361|BG000|Baseline|Experimental|Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
11306968|NCT03117361|FG000|Participant Flow|Experimental|Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
11306969|NCT03117361|OG000|Outcome|Experimental|Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
11306970|NCT03117361|EG000|Reported Event|Experimental|Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
11306971|NCT03117517|BG000|Baseline|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)"
11306972|NCT03117517|BG001|Baseline|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)"
11306973|NCT03117517|BG002|Baseline|Total|Total of all reporting groups
11306974|NCT03117517|FG000|Participant Flow|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)"
11306975|NCT03117517|FG001|Participant Flow|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)"
11306976|NCT03117517|OG000|Outcome|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)"
11306977|NCT03117517|OG001|Outcome|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)"
11306978|NCT03117517|OG000|Outcome|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)~Serum level of LH, FSH and testosterone"
11306979|NCT03117517|OG001|Outcome|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)~Serum level of LH, FSH and testosterone"
10972016|NCT00918866|OG001|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
10972017|NCT00918866|EG000|Reported Event|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
10972018|NCT00918866|EG001|Reported Event|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
11306980|NCT03117517|OG000|Outcome|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)~HOMA-IR at baseline and after treatment"
11306981|NCT03117517|OG001|Outcome|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg) HOMA-IR at baseline and after treatment"
11306982|NCT03117517|EG000|Reported Event|Metformin|"Drug intervention: Metformin 500 mg tablet twice orally for 3 months~Metformin: Metformin (1000 mg)"
11306983|NCT03117517|EG001|Reported Event|Metformin, Pioglitazone|"Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months~Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)"
11306984|NCT03117569|BG000|Baseline|Standard Monitoring Schedule|"Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306985|NCT03117569|BG001|Baseline|Simplified Monitoring Schedule|"Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306986|NCT03117569|BG002|Baseline|Total|Total of all reporting groups
11306987|NCT03117569|FG000|Participant Flow|Standard Monitoring Schedule|"Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306988|NCT03117569|FG001|Participant Flow|Simplified Monitoring Schedule|"Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306989|NCT03117569|OG000|Outcome|Standard Monitoring Schedule|"Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306990|NCT03117569|OG001|Outcome|Simplified Monitoring Schedule|"Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306991|NCT03117569|OG000|Outcome|Standard Monitoring Schedule|"Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).~glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306992|NCT03117569|OG001|Outcome|Simplified Monitoring Schedule|"Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.~glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306993|NCT03117569|OG000|Outcome|Screening|Health Practitioner attitudes regarding the model of care as expressed via questionnaire completed prior to first patient first visit.
11306994|NCT03117569|OG001|Outcome|Post Treatment Week 12|Health Practitioner attitudes regarding the model of care as expressed via questionnaire completed after the last patient last visit.
11306995|NCT03117569|EG000|Reported Event|Standard Monitoring Schedule|"Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306996|NCT03117569|EG001|Reported Event|Simplified Monitoring Schedule|"Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.~Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks"
11306997|NCT03117634|BG000|Baseline|Personalised Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT.~At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards."
11306998|NCT03117634|BG001|Baseline|Fixed Group|"All Study participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT.~Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study."
11306999|NCT03117634|BG002|Baseline|Total|Total of all reporting groups
11307000|NCT03117634|FG000|Participant Flow|Personalised Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT.~At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards."
11307001|NCT03117634|FG001|Participant Flow|Fixed Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT.~Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study."
11307002|NCT03117634|OG000|Outcome|Personalised Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT.~At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards."
11307003|NCT03117634|OG001|Outcome|Fixed Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT.~Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study."
11307004|NCT03117634|EG000|Reported Event|Personalised Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT.~At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards."
11307005|NCT03117634|EG001|Reported Event|Fixed Group|"The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT.~Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study."
11307006|NCT03117738|BG000|Baseline|AstroStem|AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
11307007|NCT03117738|BG001|Baseline|Placebo-Control|Placebo-Control: Saline with 30% auto-serum
11307008|NCT03117738|BG002|Baseline|Total|Total of all reporting groups
11307009|NCT03117738|FG000|Participant Flow|AstroStem|AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC) 2x10e8 cells
11307010|NCT03117738|FG001|Participant Flow|Placebo-Control|Saline with 30% auto-serum
11307011|NCT03117738|OG000|Outcome|AstroStem|AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
11307012|NCT03117738|OG001|Outcome|Placebo-Control|Placebo-Control: Saline with 30% auto-serum
11307013|NCT03117738|EG000|Reported Event|AstroStem|AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
11307014|NCT03117738|EG001|Reported Event|Placebo-Control|Placebo-Control: Saline with 30% auto-serum
11307015|NCT03118297|BG000|Baseline|Ulipristal Acetate|"15mg ulipristal acetate (capsule) daily for 7 days~Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307016|NCT03118297|BG001|Baseline|Placebo|"Identical placebo (capsule) daily for 7 days~Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307017|NCT03118297|BG002|Baseline|Total|Total of all reporting groups
11307018|NCT03118297|FG000|Participant Flow|Ulipristal Acetate|"15mg ulipristal acetate (capsule) daily for 7 days~Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307019|NCT03118297|FG001|Participant Flow|Placebo|"Identical appearing placebo (capsule) daily for 7 days~Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307020|NCT03118297|OG000|Outcome|Ulipristal Acetate|"15mg ulipristal acetate (capsule) daily for 7 days~Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307021|NCT03118297|OG001|Outcome|Placebo|"Identical placebo (capsule) daily for 7 days~Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307022|NCT03118297|EG000|Reported Event|Ulipristal Acetate|"15mg ulipristal acetate (capsule) daily for 7 days~Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307023|NCT03118297|EG001|Reported Event|Placebo|"Identical placebo (capsule) daily for 7 days~Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days."
11307024|NCT03118466|BG000|Baseline|Lenalidomide and MEC Chemotherapy|"Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.~Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.~Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.~Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production~Mitoxantrone: It interfere with cell reproduction"
11307025|NCT03118466|FG000|Participant Flow|Lenalidomide and MEC Chemotherapy|"Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.~Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.~Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.~Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production~Mitoxantrone: It interfere with cell reproduction"
10972019|NCT00918879|BG000|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
10972020|NCT00918879|BG001|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
11307026|NCT03118466|OG000|Outcome|Lenalidomide and MEC Chemotherapy|"Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.~Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.~Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.~Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production~Mitoxantrone: It interfere with cell reproduction"
11307027|NCT03118466|EG000|Reported Event|Lenalidomide and MEC Chemotherapy|"Lenalidomide is taken orally on a daily basis days 1-10. Mitoxantrone, Etoposide, and Cytarabine are administered intravenously on a daily basis for days 4 through 8 of the treatment. There is only one cycle of treatment in this study.~Etoposide: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.~Cytarabine: Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.~Lenalidomide: It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production~Mitoxantrone: It interfere with cell reproduction"
11307028|NCT03118518|BG000|Baseline|Subjects Treated With Cryoballoon Catheter Ablation as Randomized|Subjects Treated with Cryoballoon Catheter Ablation as Randomized.
11307029|NCT03118518|BG001|Baseline|Subjects Treated With Antiarrhythmic Drug Initiation|Subjects Treated with Antiarrhythmic Drug Initiation.
11307030|NCT03118518|BG002|Baseline|Total|Total of all reporting groups
11307031|NCT03118518|FG000|Participant Flow|Subjects Randomized to Cryoballoon Catheter Ablation|Subjects Randomized to Cryoballoon Catheter Ablation.
11307032|NCT03118518|FG001|Participant Flow|Subjects Randomized to Antiarrhythmic Drug Therapy|Subjects Randomized to Antiarrhythmic Drug Therapy.
11307033|NCT03118518|OG000|Outcome|Subjects Treated With Cryoballoon Catheter Ablation as Randomized|Subjects Treated with Cryoballoon Catheter Ablation as Randomized.
11307034|NCT03118518|OG001|Outcome|Subjects Treated With Antiarrhythmic Drug Initiation|Subjects Treated with Antiarrhythmic Drug Initiation.
11307035|NCT03118518|EG000|Reported Event|Randomized and Treated With Cryoablation|Subjects Treated with Cryoballoon Catheter Ablation as Randomized.
11307036|NCT03118518|EG001|Reported Event|Randomized and Treated With Antiarrhythmic Drugs|Subjects Treated with Antiarrhythmic Drug Initiation as Randomized
11307037|NCT03118596|BG000|Baseline|I-gel|"Fibreoptic guided tracheal intubation through I-gel~I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway."
11307038|NCT03118596|BG001|Baseline|LMA Protector|"Fibreoptic guided tracheal intubation through Protector~LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway."
11307039|NCT03118596|BG002|Baseline|Total|Total of all reporting groups
11307040|NCT03118596|FG000|Participant Flow|I-gel|"Fibreoptic guided tracheal intubation through I-gel~I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway."
11307041|NCT03118596|FG001|Participant Flow|LMA Protector|"Fibreoptic guided tracheal intubation through Protector~LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway."
11307042|NCT03118596|OG000|Outcome|I-gel|"Fibreoptic guided tracheal intubation through I-gel~I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway."
11307043|NCT03118596|OG001|Outcome|LMA Protector|"Fibreoptic guided tracheal intubation through Protector~LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway."
11307044|NCT03118596|EG000|Reported Event|I-gel|"Fibreoptic guided tracheal intubation through I-gel~I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway."
11307045|NCT03118596|EG001|Reported Event|LMA Protector|"Fibreoptic guided tracheal intubation through Protector~LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway."
11307046|NCT03118739|BG000|Baseline|Verinurad 9 mg+Febuxostat 80 mg|Capsule administered orally, once daily for 24 weeks
11307047|NCT03118739|BG001|Baseline|Placebo|Capsule administered orally, once daily for 24 weeks
11307048|NCT03118739|BG002|Baseline|Total|Total of all reporting groups
11307049|NCT03118739|FG000|Participant Flow|Verinurad 9 mg+Febuxostat 80 mg|Capsule administered orally, once daily for 24 weeks
11307050|NCT03118739|FG001|Participant Flow|Placebo|Capsule administered orally, once daily for 24 weeks
11307051|NCT03118739|OG000|Outcome|Verinurad 9 mg+Febuxostat 80 mg|Capsule administered orally, once daily for 24 weeks
11307052|NCT03118739|OG001|Outcome|Placebo|Capsule administered orally, once daily for 24 weeks
11307053|NCT03118739|EG000|Reported Event|Verinurad 9 mg+Febuxostat 80 mg|Capsule administered orally, once daily for 24 weeks
11307054|NCT03118739|EG001|Reported Event|Placebo|Capsule administered orally, once daily for 24 weeks
11307055|NCT03118765|BG000|Baseline|GSP304 10 μg|Oral inhalation, once daily (morning) for 21 days
11307056|NCT03118765|BG001|Baseline|GSP304 20 μg|Oral inhalation, once daily (morning) for 21 days
11307057|NCT03118765|BG002|Baseline|GSP304 40 μg|Oral inhalation, once daily (morning) for 21 days
11307058|NCT03118765|BG003|Baseline|Placebo|Oral inhalation, once daily (morning) for 21 days
11307059|NCT03118765|BG004|Baseline|SPIRIVA RESPIMAT 5 μg|Oral inhalation, once daily (morning) for 21 days
11307060|NCT03118765|BG005|Baseline|Total|Total of all reporting groups
11307061|NCT03118765|FG000|Participant Flow|GSP304 10 μg|Oral inhalation, once daily (morning) for 21 days
11307062|NCT03118765|FG001|Participant Flow|GSP304 20 μg|Oral inhalation, once daily (morning) for 21 days
11307063|NCT03118765|FG002|Participant Flow|GSP304 40 μg|Oral inhalation, once daily (morning) for 21 days
11307064|NCT03118765|FG003|Participant Flow|Placebo|Oral inhalation, once daily (morning) for 21 days
11307065|NCT03118765|FG004|Participant Flow|SPIRIVA RESPIMAT 5 μg|Oral inhalation, once daily (morning) for 21 days
11307066|NCT03118765|OG000|Outcome|GSP304 10 μg|Oral inhalation, once daily (morning) for 21 days
11307067|NCT03118765|OG001|Outcome|GSP304 20 μg|Oral inhalation, once daily (morning) for 21 days
11307068|NCT03118765|OG002|Outcome|GSP304 40 μg|Oral inhalation, once daily (morning) for 21 days
11307069|NCT03118765|OG003|Outcome|SPIRIVA RESPIMAT 5 μg|Oral inhalation, once daily (morning) for 21 days
11307070|NCT03118765|OG003|Outcome|Placebo|Oral inhalation, once daily (morning) for 21 days
11307071|NCT03118765|OG004|Outcome|SPIRIVA RESPIMAT 5 μg|Oral inhalation, once daily (morning) for 21 days
11307072|NCT03118765|EG000|Reported Event|GSP304 10 μg|Oral inhalation, once daily (morning) for 21 days
11307073|NCT03118765|EG001|Reported Event|GSP304 20 μg|Oral inhalation, once daily (morning) for 21 days
11307074|NCT03118765|EG002|Reported Event|GSP304 40 μg|Oral inhalation, once daily (morning) for 21 days
11307075|NCT03118765|EG003|Reported Event|Placebo|Oral inhalation, once daily (morning) for 21 days
11307076|NCT03118765|EG004|Reported Event|SPIRIVA RESPIMAT 5 μg|Oral inhalation, once daily (morning) for 21 days
11307077|NCT03118843|BG000|Baseline|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
10848510|NCT00290238|OG000|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
11307078|NCT03118843|FG000|Participant Flow|SOF/VEL/VOX|Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
11307079|NCT03118843|OG000|Outcome|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
11307080|NCT03118843|EG000|Reported Event|SOF/VEL/VOX|SOF/VEL/VOX (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
11307081|NCT03118934|BG000|Baseline|AOA MF|Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days
11307082|NCT03118934|BG001|Baseline|DACP MF|Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307083|NCT03118934|BG002|Baseline|DT1 MF|Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307084|NCT03118934|BG003|Baseline|Total|Total of all reporting groups
11307085|NCT03118934|FG000|Participant Flow|AOA MF - Alternative|Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days
11307086|NCT03118934|FG001|Participant Flow|DACP MF - Alternative|Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307087|NCT03118934|FG002|Participant Flow|DT1 MF - Alternative|Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307088|NCT03118934|FG003|Participant Flow|AOA MF - Current|Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
11307089|NCT03118934|FG004|Participant Flow|DACP MF - Current|Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307090|NCT03118934|FG005|Participant Flow|DT1 MF - Current|Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
11307091|NCT03118934|OG000|Outcome|Alternative|Bilaterally fitted with trial lenses using the alternative fitting guide
11307092|NCT03118934|OG001|Outcome|Current|Bilaterally fitted with trial lenses using the current fitting guide
11307093|NCT03118934|EG000|Reported Event|AOA MF Ocular|Eyes exposed to AIR OPTIX AQUA® Multifocal (AOA MF) contact lenses
11307094|NCT03118934|EG001|Reported Event|AOA MF Nonocular|Subjects exposed to AOA MF contact lenses
11307095|NCT03118934|EG002|Reported Event|DACP MF Ocular|Eyes exposed to DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lenses
11307096|NCT03118934|EG003|Reported Event|DACP MF Nonocular|Subjects exposed to DACP MF contact lenses
10972021|NCT00918879|BG002|Baseline|Total|Total of all reporting groups
11307097|NCT03118934|EG004|Reported Event|DT1 MF Ocular|Eyes exposed to DAILIES TOTAL1® Multifocal (DT1 MF) contact lenses
11307098|NCT03118934|EG005|Reported Event|DT1 MF Nonocular|Subjects exposed to DT1 MF contact lenses
11307099|NCT03118947|BG000|Baseline|All Patients|All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
11307100|NCT03118947|FG000|Participant Flow|All Patients|All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
11307101|NCT03118947|OG000|Outcome|All Patients|All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
11307102|NCT03118947|EG000|Reported Event|All Patients|All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
11307103|NCT03119025|BG000|Baseline|Autologous DC-vaccines|"Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins.~Autologous DC-vaccines: Patients were vaccinated via intracutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU).~Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up)."
11307104|NCT03119025|FG000|Participant Flow|Autologous DC-vaccines|"Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins.~Autologous DC-vaccines: Patients were vaccinated via intracutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU).~Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up)."
11307105|NCT03119025|OG000|Outcome|Autologous DC-vaccines|"Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins.~Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU).~Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up)."
11307106|NCT03119025|EG000|Reported Event|Autologous DC-vaccines|"Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins.~Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU).~Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up)."
11307107|NCT03119168|BG000|Baseline|Simethicone Solution + Polyethylenglycol|"This arm of the study will include the patients assigned to take simethicone solution with their colon preparations~Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol"
11307108|NCT03119168|BG001|Baseline|Polyethylenglycol|"This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol~Polyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation"
11307109|NCT03119168|BG002|Baseline|Total|Total of all reporting groups
11307110|NCT03119168|FG000|Participant Flow|Simethicone Solution + Polyethylenglycol|"This arm of the study will include the patients assigned to take simethicone solution with their colon preparation (4L Polyethylenglycol)~Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus 4 L of polyethylenglycol"
11307111|NCT03119168|FG001|Participant Flow|Polyethylenglycol|"This arm of the study will include the patients assigned to take a regular bowel preparation with 4L Polyethylenglycol~Polyethylenglycol: All patients were assigned to take 4L polyethylenglycol as their regular bowel preparation"
11307112|NCT03119168|OG000|Outcome|Simethicone Solution + Polyethylenglycol|"This arm of the study will include the patients assigned to take simethicone solution with their colon preparations~Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol"
11307113|NCT03119168|OG001|Outcome|Polyethylenglycol|"This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol~Polyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation"
11307114|NCT03119168|OG000|Outcome|Simethicone Solution + Polyethylenglycol|The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
11307115|NCT03119168|OG001|Outcome|Polyethylenglycol|The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope
11307116|NCT03119168|EG000|Reported Event|Simethicone Solution + Polyethylenglycol|Simethicone solution + Polyethylenglycol were received as a bowel prep regimen
11307117|NCT03119168|EG001|Reported Event|Polyethylenglycol|Polyethylenglycol was received as a bowel prep regimen
11307118|NCT03119181|BG000|Baseline|Active Tymbion Iontophoresis|"Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.~Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM"
11307119|NCT03119181|BG001|Baseline|Sham Tymbion Iontophoresis|"The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated.~Tymbion Lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution"
11307120|NCT03119181|BG002|Baseline|Total|Total of all reporting groups
10972022|NCT00918879|FG000|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
11307121|NCT03119181|FG000|Participant Flow|Active Tymbion Iontophoresis|"Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.~Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM"
10972023|NCT00918879|FG001|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10972024|NCT00918879|OG000|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
10972025|NCT00918879|OG001|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
11307122|NCT03119181|FG001|Participant Flow|Sham Tymbion Iontophoresis|"The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated.~Tymbion Lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution"
11307123|NCT03119181|OG000|Outcome|Active Tymbion Iontophoresis|"Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.~Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM"
11307124|NCT03119181|OG001|Outcome|Sham Tymbion Iontophoresis|"The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated.~Tymbion Lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution"
11307125|NCT03119181|EG000|Reported Event|Active Tymbion Iontophoresis|"Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.~Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM"
11307126|NCT03119181|EG001|Reported Event|Sham Tymbion Iontophoresis|"The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated.~Tymbion Lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution"
11307127|NCT03119389|BG000|Baseline|Donning Non-Sterile Gloves Without HH|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.~Donning Non-Sterile Gloves without hand hygiene: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.~Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms."
11307128|NCT03119389|BG001|Baseline|HH Before Donning Non-Sterile Gloves|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.~Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms."
11307129|NCT03119389|BG002|Baseline|Total|Total of all reporting groups
11307130|NCT03119389|FG000|Participant Flow|HH Before Donning Non-Sterile Gloves|In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain percentages for each outcome.
11307131|NCT03119389|FG001|Participant Flow|Donning Non-Sterile Gloves Without HH|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.~Donning Non-Sterile Gloves without HH: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.~Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain percentages for each outcome."
11307132|NCT03119389|OG000|Outcome|Donning Non-Sterile Gloves Without Hand Hygiene|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.~Donning Non-Sterile Gloves without hand hygiene: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.~Individual healthcare workers within each unit were observed for the primary outcome in order to obtain unit adherence for the primary outcome"
11307133|NCT03119389|OG001|Outcome|Hand Hygiene Before Donning Non-Sterile Gloves|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.~Individual healthcare workers within each unit were observed for the primary outcome in order to obtain unit adherence for the primary outcome"
11307134|NCT03119389|OG000|Outcome|Donning Non-Sterile Gloves Without Hand Hygiene|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary.~Donning Non-Sterile Gloves without hand hygiene: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary."
11307135|NCT03119389|OG001|Outcome|Hand Hygiene Before Donning Non-Sterile Gloves|In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
11307136|NCT03119389|EG000|Reported Event|HH Before Donning Non-Sterile Gloves|In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary. For Aim A, observations will be made on compliance at entry and exit with hand hygiene and glove use. For Aim B, samples will be obtained from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens
10972026|NCT00918879|EG000|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
10972027|NCT00918879|EG001|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
10972028|NCT00918931|BG000|Baseline|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
10972029|NCT00918931|FG000|Participant Flow|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
11307137|NCT03119389|EG001|Reported Event|Donning Non-Sterile Gloves Without HH|"In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary. For Aim A, observations will be made on compliance at entry and exit with hand hygiene and glove use. For Aim B, samples will be obtained from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens~Donning Non-Sterile Gloves without HH: Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary."
11307138|NCT03119571|BG000|Baseline|Initial CCL Admission|"Admission to the CCL to evaluate the coronary artery disease~Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions"
11307139|NCT03119571|BG001|Baseline|Initial ICU Admission|"Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.~Initial ICU admission: Evaluate for additional testing and/or procedures"
11307140|NCT03119571|BG002|Baseline|Total|Total of all reporting groups
11307141|NCT03119571|FG000|Participant Flow|Initial CCL Admission|"Admission to the CCL to evaluate the coronary artery disease~Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions"
11307142|NCT03119571|FG001|Participant Flow|Initial ICU Admission|"Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.~Initial ICU admission: Evaluate for additional testing and/or procedures"
11307143|NCT03119571|OG000|Outcome|Initial CCL Admission|"Admission to the CCL to evaluate the coronary artery disease~Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions"
11307144|NCT03119571|OG001|Outcome|Initial ICU Admission|"Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.~Initial ICU admission: Evaluate for additional testing and/or procedures"
11307145|NCT03119571|EG000|Reported Event|Initial CCL Admission|"Admission to the CCL to evaluate the coronary artery disease~Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions"
11307146|NCT03119571|EG001|Reported Event|Initial ICU Admission|"Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.~Initial ICU admission: Evaluate for additional testing and/or procedures"
10972030|NCT00918931|OG000|Outcome|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
11307147|NCT03119610|BG000|Baseline|Oxytocin Nasal Spray|"Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered~Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)"
11307148|NCT03119610|BG001|Baseline|Placebo Nasal Spray|"Placebo nasal spray, 4x a day for 8 weeks, self administered~Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)"
11307149|NCT03119610|BG002|Baseline|Total|Total of all reporting groups
11307150|NCT03119610|FG000|Participant Flow|Oxytocin Nasal Spray|"Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered~Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)"
11307151|NCT03119610|FG001|Participant Flow|Placebo Nasal Spray|"Placebo nasal spray, 4x a day for 8 weeks, self administered~Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)"
11307152|NCT03119610|OG000|Outcome|Oxytocin Nasal Spray|"Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered~Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)"
11307153|NCT03119610|OG001|Outcome|Placebo Nasal Spray|"Placebo nasal spray, 4x a day for 8 weeks, self administered~Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)"
10848511|NCT00290238|OG001|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
10848512|NCT00290238|EG000|Reported Event|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
10972031|NCT00918931|EG000|Reported Event|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
10972032|NCT00918957|BG000|Baseline|TIP (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
11307154|NCT03119610|EG000|Reported Event|Oxytocin Nasal Spray|"Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered~Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)"
11307155|NCT03119610|EG001|Reported Event|Placebo Nasal Spray|"Placebo nasal spray, 4x a day for 8 weeks, self administered~Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)"
11307156|NCT03119649|BG000|Baseline|Pooled Placebo|Participants received three matching placebo tablets orally, QD for 29 days.
11307157|NCT03119649|BG001|Baseline|Cohort A: GLPG2222 50 mg QD|Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307158|NCT03119649|BG002|Baseline|Cohort A: GLPG2222 100 mg QD|Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307159|NCT03119649|BG003|Baseline|Cohort B: GLPG2222 200 mg QD|Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
11307160|NCT03119649|BG004|Baseline|Cohort B: GLPG2222 400 mg QD|Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
11307161|NCT03119649|BG005|Baseline|Total|Total of all reporting groups
11307162|NCT03119649|FG000|Participant Flow|Pooled Placebo|Participants received three matching placebo tablets orally, once a day (QD) for 29 days.
11307163|NCT03119649|FG001|Participant Flow|Cohort A: GLPG2222 50 mg QD|Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307164|NCT03119649|FG002|Participant Flow|Cohort A: GLPG2222 100 mg QD|Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307165|NCT03119649|FG003|Participant Flow|Cohort B: GLPG2222 200 mg QD|Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
11307166|NCT03119649|FG004|Participant Flow|Cohort B: GLPG2222 400 mg QD|Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet, orally, QD for 29 days.
11307167|NCT03119649|OG000|Outcome|Pooled Placebo|Participants received three matching placebo tablets orally, QD for 29 days.
11307168|NCT03119649|OG001|Outcome|Cohort A: GLPG2222 50 mg QD|Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307169|NCT03119649|OG002|Outcome|Cohort A: GLPG2222 100 mg QD|Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307170|NCT03119649|OG003|Outcome|Cohort B: GLPG2222 200 mg QD|Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
11307171|NCT03119649|OG004|Outcome|Cohort B: GLPG2222 400 mg QD|Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
11307172|NCT03119649|OG000|Outcome|Cohort A: GLPG2222 50 mg QD|Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307173|NCT03119649|OG001|Outcome|Cohort A: GLPG2222 100 mg QD|Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307174|NCT03119649|OG002|Outcome|Cohort B: GLPG2222 200 mg QD|Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
11307175|NCT03119649|OG003|Outcome|Cohort B: GLPG2222 400 mg QD|Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
11307176|NCT03119649|EG000|Reported Event|Pooled Placebo|Participants received three matching placebo tablets orally, QD for 29 days.
11307177|NCT03119649|EG001|Reported Event|Cohort A: GLPG2222 50 mg QD|Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307178|NCT03119649|EG002|Reported Event|Cohort A: GLPG2222 100 mg QD|Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
11307179|NCT03119649|EG003|Reported Event|Cohort B: GLPG2222 200 mg QD|Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
11307180|NCT03119649|EG004|Reported Event|Cohort B: GLPG2222 400 mg QD|Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
11307181|NCT03119688|BG000|Baseline|Overall Participants|All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
11307182|NCT03119688|FG000|Participant Flow|Overall Participants|All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
11307183|NCT03119688|OG000|Outcome|Test|Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.
11307184|NCT03119688|OG001|Outcome|Positive Control|Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
11307185|NCT03119688|OG002|Outcome|Negative Control|Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.
11307186|NCT03119688|OG003|Outcome|No Treatment|Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
11307187|NCT03119688|OG000|Outcome|Test|Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study.
11307188|NCT03119688|OG002|Outcome|Negative Control|Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water ) was applied during the study.
11307189|NCT03119688|OG003|Outcome|Reference (Unwashed Area)|Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
11307190|NCT03119688|OG003|Outcome|Reference (Unwashed Area)|Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study
11307191|NCT03119688|OG000|Outcome|Test Product|Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser)was applied during the study..
11307192|NCT03119688|OG002|Outcome|Negative Control|Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study
11307193|NCT03119688|EG000|Reported Event|Test|Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study..
11307194|NCT03119688|EG001|Reported Event|Positive Control|Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.
11307195|NCT03119688|EG002|Reported Event|Negative Control|Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.
11307196|NCT03119688|EG003|Reported Event|No Treatment|Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
11307197|NCT03119688|EG004|Reported Event|Overall Participants|Included all participants who applied any of the study products.
11307198|NCT03119701|BG000|Baseline|FP-1201-lyo 10 µg|"FP-1201-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon Beta-1a: investigational drug."
11307199|NCT03119701|BG001|Baseline|FP-1201-lyo Placebo|"FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection~Placebo: placebo for Investigational drug."
11307200|NCT03119701|BG002|Baseline|Total|Total of all reporting groups
11307201|NCT03119701|FG000|Participant Flow|FP-1201-lyo 10 µg|"FP-1201-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon Beta-1a: investigational drug."
11307202|NCT03119701|FG001|Participant Flow|FP-1201-lyo Placebo|"FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection~Placebo: placebo for investigational drug."
11307203|NCT03119701|OG000|Outcome|FP-1201-lyo 10 µg|"FP-1201-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon Beta-1a: investigational drug."
11307204|NCT03119701|OG001|Outcome|FP-1201-lyo Placebo|"FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection~Placebo: placebo for investigational drug."
11307205|NCT03119701|EG000|Reported Event|FP-1201-lyo 10 µg|"FP-1201-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon Beta-1a: investigational drug."
11307206|NCT03119701|EG001|Reported Event|FP-1201-lyo Placebo|"FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection~Placebo: placebo for investigational drug."
11307207|NCT03119831|BG000|Baseline|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307208|NCT03119831|BG001|Baseline|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%~Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307209|NCT03119831|BG002|Baseline|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%~Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307210|NCT03119831|BG003|Baseline|Total|Total of all reporting groups
11307211|NCT03119831|FG000|Participant Flow|C31G (Group A)|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
10972033|NCT00918957|BG001|Baseline|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
11307212|NCT03119831|FG001|Participant Flow|Alcohol-free Chlorhexidine (Group B)|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
11307213|NCT03119831|FG002|Participant Flow|Alcohol-based Chlorhexidine (Group C)|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
11307214|NCT03119831|OG000|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
11307215|NCT03119831|OG001|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
11307216|NCT03119831|OG002|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
11307217|NCT03119831|OG000|Outcome|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307218|NCT03119831|OG001|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%~Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307219|NCT03119831|OG002|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%~Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307220|NCT03119831|EG000|Reported Event|Group A|"C31G~C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
10972034|NCT00918957|BG002|Baseline|Total|Total of all reporting groups
11307221|NCT03119831|EG001|Reported Event|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%~Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307222|NCT03119831|EG002|Reported Event|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%~Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
11307223|NCT03120013|BG000|Baseline|All Study Participants|Participants who were randomized to receive either real tDCS or sham tDCS
11307224|NCT03120013|FG000|Participant Flow|Real tDCS, Then Sham tDCS|Participants first received real tDCS (anodal cerebellar and cathodal spinal tDCS) 5 days/week for 2 weeks. After a washout period of 6 months, they then received sham tDCS (sham cerebellar and sham spinal tDCS) 5 days/week for 2 weeks.
11307225|NCT03120013|FG001|Participant Flow|Sham tDCS, Then Real tDCS|Participants first received sham tDCS (sham cerebellar and sham spinal tDCS) 5 days/week for 2 weeks. After a washout period of 6 months, they then received real tDCS (anodal cerebellar and cathodal spinal tDCS) 5 days/week for 2 weeks.
11307226|NCT03120013|OG000|Outcome|Real tDCS|"10 days anodal cerebellar and cathodal spinal tDCS~Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11307227|NCT03120013|OG001|Outcome|Sham tDCS|"10 days sham cerebellar and sham spinal tDCS~Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11307228|NCT03120013|EG000|Reported Event|Real tDCS, Then Sham tDCS|Participants who were randomized to receive real tDCS first and then sham tDCS
11307229|NCT03120013|EG001|Reported Event|Sham tDCS, Then Real tDCS|Participants who were randomized to receive sham tDCS first and then real tDCS
11307230|NCT03120351|BG000|Baseline|LIDOCAINE PATCH 5%|Lidoderm 5 % Topical Patch: Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
11307231|NCT03120351|BG001|Baseline|Placebo Patch|Placebo patch: 2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
11307232|NCT03120351|BG002|Baseline|Total|Total of all reporting groups
11307233|NCT03120351|FG000|Participant Flow|LIDOCAINE PATCH 5%|Lidoderm 5 % Topical Patch: Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
11307234|NCT03120351|FG001|Participant Flow|Placebo Patch|Placebo patch: 2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
11307235|NCT03120351|OG000|Outcome|LIDOCAINE PATCH 5%|Lidoderm 5 % Topical Patch: Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
11307236|NCT03120351|OG001|Outcome|Placebo Patch|Placebo patch: 2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
11307237|NCT03120351|EG000|Reported Event|LIDOCAINE PATCH 5%|Lidoderm 5 % Topical Patch: Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
11307238|NCT03120351|EG001|Reported Event|Placebo Patch|Placebo patch: 2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
11307239|NCT03120520|BG000|Baseline|Matching Placebo|"Taken orally once daily in the morning for 8 weeks~Matching placebo"
11307240|NCT03120520|BG001|Baseline|Plecanatide 0.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307241|NCT03120520|BG002|Baseline|Plecanatide 1.0 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307242|NCT03120520|BG003|Baseline|Plecanatide 1.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307243|NCT03120520|BG004|Baseline|Total|Total of all reporting groups
11307244|NCT03120520|FG000|Participant Flow|Matching Placebo|"Taken orally once daily in the morning for 8 weeks~Matching placebo"
11307245|NCT03120520|FG001|Participant Flow|Plecanatide 0.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
10972035|NCT00918957|FG000|Participant Flow|TIP (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
11307246|NCT03120520|FG002|Participant Flow|Plecanatide 1.0 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307247|NCT03120520|FG003|Participant Flow|Plecanatide 1.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307248|NCT03120520|OG000|Outcome|Matching Placebo|"Taken orally once daily in the morning for 8 weeks~Matching placebo"
11307249|NCT03120520|OG001|Outcome|Plecanatide 0.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307250|NCT03120520|OG002|Outcome|Plecanatide 1.0 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307251|NCT03120520|OG003|Outcome|Plecanatide 1.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307252|NCT03120520|EG000|Reported Event|Matching Placebo|"Taken orally once daily in the morning for 8 weeks~Matching placebo"
11307253|NCT03120520|EG001|Reported Event|Plecanatide 0.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307254|NCT03120520|EG002|Reported Event|Plecanatide 1.0 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307255|NCT03120520|EG003|Reported Event|Plecanatide 1.5 mg|"Taken orally once daily in the morning for 8 weeks~Plecanatide"
11307256|NCT03120832|BG000|Baseline|Cohort 1|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307257|NCT03120832|BG001|Baseline|Cohort 2|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307258|NCT03120832|BG002|Baseline|Cohort 3|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10^11 particles/administration intradermally once every 21 days.
11307259|NCT03120832|BG003|Baseline|Total|Total of all reporting groups
11307260|NCT03120832|FG000|Participant Flow|Cohort 1|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307261|NCT03120832|FG001|Participant Flow|Cohort 2|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307262|NCT03120832|FG002|Participant Flow|Cohort 3|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10^11 particles/administration intradermally once every 21 days.
11307263|NCT03120832|OG000|Outcome|Cohort 1|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307264|NCT03120832|OG001|Outcome|Cohort 2|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307265|NCT03120832|OG002|Outcome|Cohort 3|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10^11 particles/administration intradermally once every 21 days.
11307266|NCT03120832|EG000|Reported Event|Cohort 1|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307267|NCT03120832|EG001|Reported Event|Cohort 2|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10^11 particles/administration intradermally once every 21 days.
11307268|NCT03120832|EG002|Reported Event|Cohort 3|PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10^11 particles/administration intradermally once every 21 days.
11307269|NCT03121144|BG000|Baseline|Masimo Centroid System|All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
11307270|NCT03121144|FG000|Participant Flow|Masimo Centroid System|All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
11307271|NCT03121144|OG000|Outcome|Masimo Centroid System|All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
11307272|NCT03121144|EG000|Reported Event|Masimo Centroid System|All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
11307273|NCT03121365|BG000|Baseline|Standard/Board Book Arm|"Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Standard/Board books: Promotion of early reader board book reading"
11307274|NCT03121365|BG001|Baseline|Digital/E-Book Arm|"Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Digital/E-books: Promotion of early reader digital e-book reading"
11307275|NCT03121365|BG002|Baseline|Total|Total of all reporting groups
10972036|NCT00918957|FG001|Participant Flow|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
11307276|NCT03121365|FG000|Participant Flow|Standard/Board Book Arm|"Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Standard/Board books: Promotion of early reader board book reading"
11307277|NCT03121365|FG001|Participant Flow|Digital/E-Book Arm|"Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Digital/E-books: Promotion of early reader digital e-book reading"
11307278|NCT03121365|OG000|Outcome|Standard/Board Book Arm|"Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Standard/Board books: Promotion of early reader board book reading"
11307279|NCT03121365|OG001|Outcome|Digital/E-Book Arm|"Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Digital/E-books: Promotion of early reader digital e-book reading"
11307280|NCT03121365|OG000|Outcome|Standard/Board Book Arm|"Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Standard/Board Book Arm: Promotion of early reader board book reading"
11307281|NCT03121365|OG001|Outcome|Digital/E-Book Arm|"Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of enrollment. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework at their infant's 6, 9, and 12 month well visits.~Digital/E-Book Arm: Promotion of early reader digital e-book reading"
11307282|NCT03121365|EG000|Reported Event|Standard/Board Book Arm|"Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Standard/Board books: Promotion of early reader board book reading"
11307283|NCT03121365|EG001|Reported Event|Digital/E-Book Arm|"Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.~Digital/E-books: Promotion of early reader digital e-book reading"
11307284|NCT03121612|BG000|Baseline|Dolphin Continuous Positive Airway Pressure|"Continuous Positive Airway Pressure (CPAP) machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement]~CPAP: CPAP therapy"
11307285|NCT03121612|BG001|Baseline|Fisher-Paykel Continuous Positive Airway Pressure|"Fisher-Paykel (F&P) Continuous Positive Airway Pressure (CPAP) machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.~CPAP: CPAP therapy"
11307286|NCT03121612|BG002|Baseline|Total|Total of all reporting groups
11307287|NCT03121612|FG000|Participant Flow|Dolphin Continuous Positive Airway Pressure|"Continuous Positive Airway Pressure (CPAP) machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement]~CPAP: CPAP therapy"
11307288|NCT03121612|FG001|Participant Flow|Fisher-Paykel Continuous Positive Airway Pressure|"Fisher-Paykel (F&P) Continuous Positive Airway Pressure (CPAP) machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.~CPAP: CPAP therapy"
11307289|NCT03121612|OG000|Outcome|Dolphin CPAP|"CPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement]~CPAP: CPAP therapy"
11307290|NCT03121612|OG001|Outcome|Fisher-Paykel CPAP|"Fisher-Paykel (F&P) CPAP machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.~CPAP: CPAP therapy"
11307291|NCT03121612|OG000|Outcome|Dolphin Continuous Positive Airway Pressure|"Continuous Positive Airway Pressure (CPAP) machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement]~CPAP: CPAP therapy"
11307292|NCT03121612|OG001|Outcome|Fisher-Paykel Continuous Positive Airway Pressure|"Fisher-Paykel (F&P) Continuous Positive Airway Pressure (CPAP) machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.~CPAP: CPAP therapy"
11307293|NCT03121612|EG000|Reported Event|Dolphin CPAP|"CPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement]~CPAP: CPAP therapy"
11307294|NCT03121612|EG001|Reported Event|Fisher-Paykel CPAP|"Fisher-Paykel (F&P) CPAP machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.~CPAP: CPAP therapy"
11307295|NCT03121820|BG000|Baseline|Memantinol First, Then Akatinol Memantine®|"First Intervention Period (3 day):~Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state~(21 day washout period)~Second Intervention Period (3 day):~Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state"
11307296|NCT03121820|BG001|Baseline|Akatinol Memantine® First, Then Memantinol|"First Intervention Period (3 day):~Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state~(21 day washout period)~Second Intervention Period (3 day):~Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state"
11307297|NCT03121820|BG002|Baseline|Total|Total of all reporting groups
11307298|NCT03121820|FG000|Participant Flow|Memantinol First, Then Akatinol Memantine®|"First Intervention Period (3 day):~Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state~(21 day washout period)~Second Intervention Period (3 day):~Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state"
11307299|NCT03121820|FG001|Participant Flow|Akatinol Memantine® First, Then Memantinol|"First Intervention Period (3 day):~Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state~(21 day washout period)~Second Intervention Period (3 day):~Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state"
11307300|NCT03121820|OG000|Outcome|Memantinol Tablets, 20 mg|"Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC GEROPHARM, Russia - test)~Memantinol tablets, 20 mg: Bioequivalence Memantine Hydrochloride (JSC GEROPHARM, Russia) 20 mg film-coated tablets fasting condition"
11307301|NCT03121820|OG001|Outcome|Akatinol Memantine® Tablets, 20 mg|"Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH & Co. KGaA, Germany - reference)~Akatinol Memantine® tablets, 20 mg: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition"
11307302|NCT03121820|EG000|Reported Event|Memantinol Tablets, 20 mg|"Active experimental drug~Memantinol: Single orally administered dose of Memantinol (20 mg memantine) in a fasting state"
11307303|NCT03121820|EG001|Reported Event|Akatinol Memantine® Tablets, 20 mg|"Active comparator~Akatinol Memantine®: Single orally administered dose of Akatinol Memantine® (20 mg memantine) in a fasting state"
11307304|NCT03121950|BG000|Baseline|Dance in Dementia|"examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.~Dance: The primary intervention is a dance class"
11307305|NCT03121950|BG001|Baseline|Music and Dementia|"examine if listening to music improves mobility and/or cognition in individuals with dementia.~music: the secondary intervention is listening to live music"
11307306|NCT03121950|BG002|Baseline|Total|Total of all reporting groups
11307307|NCT03121950|FG000|Participant Flow|Dance in Dementia|examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
11307308|NCT03121950|FG001|Participant Flow|Music and Dementia|examine if listening to music improves mobility and/or cognition in individuals with dementia.
11307309|NCT03121950|OG000|Outcome|Dance in Dementia|"examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.~Dance: The primary intervention is a dance class"
11307310|NCT03121950|OG001|Outcome|Music and Dementia|"examine if listening to music improves mobility and/or cognition in individuals with dementia.~music: the secondary intervention is listening to live music"
11307311|NCT03121950|OG000|Outcome|Dance in Dementia|examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
11307312|NCT03121950|OG001|Outcome|Music and Dementia|examine if listening to music improves mobility and/or cognition in individuals with dementia.
11307313|NCT03121950|EG000|Reported Event|Dance in Dementia|"examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.~Dance: The primary intervention is a dance class"
11307314|NCT03121950|EG001|Reported Event|Music and Dementia|"examine if listening to music improves mobility and/or cognition in individuals with dementia.~music: the secondary intervention is listening to live music"
11307315|NCT03122145|BG000|Baseline|Healthy Volunteers - Experiment #1|This study will involve a single 60-minute visit where healthy, eligible participants will undergo testing to determine their individualized voluntary and reflexive cough testing. The participant will be free to leave at any point during the examination.
11307316|NCT03122145|BG001|Baseline|Healthy Volunteers - Experiment #2|This study will involve a single 60-minute visit where healthy, eligible participants will undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. The participant will be free to leave at any point during the examination.
11307317|NCT03122145|BG002|Baseline|Total|Total of all reporting groups
11307318|NCT03122145|FG000|Participant Flow|Healthy Volunteers - Experiment #1|"This study will involve a single 60-minute visit where healthy, eligible participants will then undergo testing to determine their individualized voluntary and reflexive cough testing. The participant will be free to leave at any point during the examination.~Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser)."
11307319|NCT03122145|FG001|Participant Flow|Healthy Volunteers - Experiment #2|This study will involve a single 60-minute visit eligible participants will then undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process prior to radiation exposure. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
11307320|NCT03122145|OG000|Outcome|Healthy Volunteers|"This study will involve a single 90-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing, tongue pressure testing and a comprehensive instrumental swallowing evaluation. The entire duration of the exam will be under 90 minutes and the participant will be free to leave at any point during the examination.~Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in"
11307321|NCT03122145|OG000|Outcome|Healthy Volunteers - Experiment 2|"This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo a instrumental swallowing evaluation (videofluoroscopy). The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.~Videofluoroscopic swallow study: The swallowing systems core laboratory is fully equipped to perform videofluoroscopy with a c-arm (OEC 9900) that is dedicated solely to research purposes. Videofluoroscopy recordings will be kept to a minimum and turned on only during completion of a specific testing task. Video recording and images captured during the videofluoroscopy will be synced and saved for data analysis. Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks."
11307322|NCT03122145|EG000|Reported Event|Healthy Volunteers - Experiment #1|"This study will involve a single 60-minute visit where healthy, eligible participants will undergo voluntary and reflexive cough testing.~Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin"
11307323|NCT03122145|EG001|Reported Event|Healthy Volunteers - Experiment #2|This study will involve a single 60-minute visit where eligible participants will undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process prior to radiation exposure. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
11333052|NCT03507036|OG000|Outcome|Treatment|"All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.~Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression. that b"
11333053|NCT03507036|EG000|Reported Event|Treatment|"All patients will undergo treatment with Profound system device (microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.~Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression."
11333054|NCT03507569|BG000|Baseline|RO7017773 - 15mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333055|NCT03507569|BG001|Baseline|RO7017773 - 30mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333056|NCT03507569|BG002|Baseline|RO7017773 - 75mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333057|NCT03507569|BG003|Baseline|RO7017773 - 375mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333058|NCT03507569|BG004|Baseline|Total|Total of all reporting groups
11333059|NCT03507569|FG000|Participant Flow|RO7017773 - 15mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333060|NCT03507569|FG001|Participant Flow|RO7017773 - 30mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333061|NCT03507569|FG002|Participant Flow|RO7017773 - 75mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333062|NCT03507569|FG003|Participant Flow|RO7017773 - 375mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
10848513|NCT00290238|EG001|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
10848514|NCT00290290|BG000|Baseline|Povidone-iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
10848515|NCT00290290|BG001|Baseline|Chlorhexidine-alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
10848516|NCT00290290|BG002|Baseline|Total|Total of all reporting groups
10848517|NCT00290290|FG000|Participant Flow|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
11307324|NCT03122171|BG000|Baseline|Prosthesis|Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
11307325|NCT03122171|FG000|Participant Flow|Prosthesis|Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
11307326|NCT03122171|OG000|Outcome|Prosthesis|Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
11307327|NCT03122171|EG000|Reported Event|Prosthesis|Occupational Therapy Treatment: Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
11307328|NCT03122184|BG000|Baseline|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting."
11307329|NCT03122184|BG001|Baseline|Motivational Interviewing Health Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.~Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction)."
11307330|NCT03122184|BG002|Baseline|Total|Total of all reporting groups
11307331|NCT03122184|FG000|Participant Flow|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting."
10848518|NCT00290290|FG001|Participant Flow|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
11307332|NCT03122184|FG001|Participant Flow|Motivational Interviewing Health Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.~Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction)."
11307333|NCT03122184|OG000|Outcome|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting."
10848519|NCT00290290|OG000|Outcome|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
10848520|NCT00290290|OG001|Outcome|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
10848521|NCT00290290|EG000|Reported Event|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
11307334|NCT03122184|OG001|Outcome|Motivational Interviewing Health Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.~Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction)."
11307335|NCT03122184|EG000|Reported Event|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting."
11307336|NCT03122184|EG001|Reported Event|Motivational Interviewing Health Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.~Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction)."
11307337|NCT03122223|BG000|Baseline|Vaccine w/ MF59|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
11307338|NCT03122223|BG001|Baseline|Vaccine w/ AS01B - High Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
11307339|NCT03122223|BG002|Baseline|Vaccine w/ AS01B - Low Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
11307340|NCT03122223|BG003|Baseline|Placebo|Placebo at Months 0, 1, 3, and 6
11307341|NCT03122223|BG004|Baseline|Total|Total of all reporting groups
11307342|NCT03122223|FG000|Participant Flow|Vaccine w/ MF59|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
11307343|NCT03122223|FG001|Participant Flow|Vaccine w/ AS01B - High Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
11307344|NCT03122223|FG002|Participant Flow|Vaccine w/ AS01B - Low Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
11307345|NCT03122223|FG003|Participant Flow|Placebo|Placebo at Months 0, 1, 3, and 6
11307346|NCT03122223|OG000|Outcome|Vaccine w/ MF59|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
11307347|NCT03122223|OG001|Outcome|Vaccine w/ AS01B - High Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
11307348|NCT03122223|OG002|Outcome|Vaccine w/ AS01B - Low Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
11307349|NCT03122223|OG003|Outcome|Placebo|Placebo at Months 0, 1, 3, and 6
11307350|NCT03122223|EG000|Reported Event|Vaccine w/ MF59|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
11307351|NCT03122223|EG001|Reported Event|Vaccine w/ AS01B - High Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
11307352|NCT03122223|EG002|Reported Event|Vaccine w/ AS01B - Low Dose|ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
11307353|NCT03122223|EG003|Reported Event|Placebo|Placebo at Months 0, 1, 3, and 6
10972037|NCT00918957|OG000|Outcome|TIP (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
11307354|NCT03122457|BG000|Baseline|Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo|lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
11307355|NCT03122457|FG000|Participant Flow|Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo|lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
11307356|NCT03122457|OG000|Outcome|Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo|lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
11307357|NCT03122457|EG000|Reported Event|Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo|lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
11307358|NCT03122535|BG000|Baseline|All Participants|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307359|NCT03122535|FG000|Participant Flow|FS-LASIK 70 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307360|NCT03122535|FG001|Participant Flow|FS-LASIK 110 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307361|NCT03122535|OG000|Outcome|FS-LASIK 70 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307362|NCT03122535|OG001|Outcome|FS-LASIK 110 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307363|NCT03122535|EG000|Reported Event|FS-LASIK 70 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307364|NCT03122535|EG001|Reported Event|FS-LASIK 110 Degree Side-cut Angle|"Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.~FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.~FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."
11307365|NCT03122548|BG000|Baseline|CRS-207 + Pembrolizumab|Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
11307366|NCT03122548|FG000|Participant Flow|CRS-207 + Pembrolizumab|Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 colony forming units (CFU) administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
11307367|NCT03122548|OG000|Outcome|CRS-207 + Pembrolizumab|Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
10972038|NCT00918957|OG001|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
11307368|NCT03122548|EG000|Reported Event|CRS-207 + Pembrolizumab|Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).
11307369|NCT03122587|BG000|Baseline|Active Sham Stimulation (Session 1 and Session 2)|Active sham transcranial alternating current stimulation: Active sham (placebo)
11307370|NCT03122587|BG001|Baseline|Active Sham (Session 1) and tACS at 10 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2~Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity"
11307371|NCT03122587|BG002|Baseline|Active Sham (Session 1) and tACS at 40 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2~Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity"
11307372|NCT03122587|BG003|Baseline|Total|Total of all reporting groups
11307373|NCT03122587|FG000|Participant Flow|Active Sham Stimulation (Session 1 and Session 2)|Active sham transcranial alternating current stimulation: Active sham (placebo)
11307374|NCT03122587|FG001|Participant Flow|Active Sham (Session 1) and tACS at 10 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2~Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity"
11307375|NCT03122587|FG002|Participant Flow|Active Sham (Session 1) and tACS at 40 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2~Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity"
11307376|NCT03122587|OG000|Outcome|Active Sham Stimulation (Session 1 and Session 2)|Active sham transcranial alternating current stimulation: Active sham (placebo)
11307377|NCT03122587|OG001|Outcome|Active Sham (Session 1) and tACS at 10 Hz (Session 2)|Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2 Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
11307378|NCT03122587|OG002|Outcome|Active Sham (Session 1) and tACS at 40 Hz (Session 2)|Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
11307379|NCT03122587|EG000|Reported Event|Active Sham Stimulation|Active sham transcranial alternating current stimulation: Active sham (placebo)
11307380|NCT03122587|EG001|Reported Event|Active Sham (Session 1) and tACS at 10 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2~Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity"
11307381|NCT03122587|EG002|Reported Event|Active Sham (Session 1) and tACS at 40 Hz (Session 2)|"Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2~Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity"
11307382|NCT03122860|BG000|Baseline|0.03 mg SM04690|Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
11307383|NCT03122860|BG001|Baseline|0.07 mg SM04690|Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
11307384|NCT03122860|BG002|Baseline|0.15 mg SM04690|Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
11307385|NCT03122860|BG003|Baseline|0.23 mg SM04690|Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
10972039|NCT00918957|EG000|Reported Event|TIP (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
11307386|NCT03122860|BG004|Baseline|Placebo|Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
11307387|NCT03122860|BG005|Baseline|Sham|Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
11307388|NCT03122860|BG006|Baseline|Total|Total of all reporting groups
11307389|NCT03122860|FG000|Participant Flow|0.03 mg SM04690|Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
11307390|NCT03122860|FG001|Participant Flow|0.07 mg SM04690|Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
11307391|NCT03122860|FG002|Participant Flow|0.15 mg SM04690|Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
11307392|NCT03122860|FG003|Participant Flow|0.23 mg SM04690|Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
11307393|NCT03122860|FG004|Participant Flow|Placebo|Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
11307394|NCT03122860|FG005|Participant Flow|Sham|Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
11307395|NCT03122860|OG000|Outcome|0.03 mg SM04690|Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
11307396|NCT03122860|OG001|Outcome|0.07 mg SM04690|Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
11307397|NCT03122860|OG002|Outcome|0.15 mg SM04690|Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
11307398|NCT03122860|OG003|Outcome|0.23 mg SM04690|Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
11307399|NCT03122860|OG004|Outcome|Placebo|Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
11307400|NCT03122860|OG005|Outcome|Sham|Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
11307401|NCT03122860|EG000|Reported Event|0.03 mg SM04690|Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
11307402|NCT03122860|EG001|Reported Event|0.07 mg SM04690|Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
11307403|NCT03122860|EG002|Reported Event|0.15 mg SM04690|Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
11307404|NCT03122860|EG003|Reported Event|0.23 mg SM04690|Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
11307405|NCT03122860|EG004|Reported Event|Placebo|Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
11307406|NCT03122860|EG005|Reported Event|Sham|Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
11307407|NCT03122860|EG006|Reported Event|Other|Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.
11307408|NCT03123055|BG000|Baseline|Phase 2|B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
11307409|NCT03123055|FG000|Participant Flow|Phase 2|B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
11307410|NCT03123055|OG000|Outcome|B-701 (Vofatamab) Plus Pembrolizumab|B-701 (vofatamab) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks in a 6+6 dose escalation designed to determine the RP2D of the combination.
11307411|NCT03123055|OG000|Outcome|Phase 2|B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
11307412|NCT03123055|EG000|Reported Event|Phase 2|B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
11307413|NCT03123068|BG000|Baseline|Active Treatment Group - Group A|"Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~CocoaVia®: CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule."
11307414|NCT03123068|BG001|Baseline|Placebo Treatment Group - Group B|"Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~Placebo: The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment."
11307415|NCT03123068|BG002|Baseline|Total|Total of all reporting groups
11307416|NCT03123068|FG000|Participant Flow|Active Treatment Group - Group A|"Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~CocoaVia®: CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule."
11307417|NCT03123068|FG001|Participant Flow|Placebo Treatment Group - Group B|"Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~Placebo: The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment."
11307418|NCT03123068|OG000|Outcome|Active Treatment Group - Group A|"Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~CocoaVia®: CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule."
11307419|NCT03123068|OG001|Outcome|Placebo Treatment Group - Group B|"Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~Placebo: The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment."
11307420|NCT03123068|EG000|Reported Event|Active Treatment Group - Group A|"Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~CocoaVia®: CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule."
11307421|NCT03123068|EG001|Reported Event|Placebo Treatment Group - Group B|"Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.~Placebo: The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment."
11307422|NCT03123120|BG000|Baseline|Placebo - Randomized|"Matching placebo was administered via intravenous infusion over 12 weeks of treatment.~Participants who were randomized into the Placebo treatment were included in this arm."
11307423|NCT03123120|BG001|Baseline|Spesolimab 1200 mg - Randomized|"1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).~Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm."
11307424|NCT03123120|BG002|Baseline|Total|Total of all reporting groups
11307425|NCT03123120|FG000|Participant Flow|Placebo - Randomized|"Matching placebo was administered via intravenous infusion over 12 weeks of treatment.~Participants who were randomized into the Placebo treatment were included in this arm."
11307426|NCT03123120|FG001|Participant Flow|Spesolimab 1200 mg - Randomized|"1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).~Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm."
11307427|NCT03123120|OG000|Outcome|Placebo - Randomized|"Matching placebo was administered via intravenous infusion over 12 weeks of treatment.~Participants who were randomized into the Placebo treatment were included in this arm."
11307428|NCT03123120|OG001|Outcome|Spesolimab 1200 mg - Randomized|"1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).~Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm."
11307429|NCT03123120|OG000|Outcome|Placebo - Actual|Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.
11333063|NCT03507569|OG000|Outcome|RO7017773 - 15mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11307430|NCT03123120|OG001|Outcome|Spesolimab 1200 mg - Actual|"1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment.~Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group."
11307431|NCT03123120|EG000|Reported Event|Placebo - Actual|Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group.
11307432|NCT03123120|EG001|Reported Event|Spesolimab 1200 mg - Actual|"1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment.~Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group."
11307433|NCT03123263|BG000|Baseline|Trastuzumab-treated Breast Cancer Patients|Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
11307434|NCT03123263|FG000|Participant Flow|Trastuzumab-treated Breast Cancer Patients|Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
11307435|NCT03123263|OG000|Outcome|Patients|LVEF prior to therapy
11307436|NCT03123263|OG001|Outcome|LVEF at 3-6months|Left ventricular ejection fraction at mid point
11307437|NCT03123263|OG002|Outcome|LVEF End of Therapy|left ventricular ejection fraction at end of therapy.
11307438|NCT03123263|OG000|Outcome|Hospitalizations Due to Cardiac Complications|Patient who had hospitalization related to cardiac complications
11307439|NCT03123263|EG000|Reported Event|Trastuzumab-treated Breast Cancer Patients|Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
11307440|NCT03123354|BG000|Baseline|O3 Regional Oximeter Sensors|"All subjects are enrolled in the test group and receive the O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.~O3 regional oximeter sensor: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor."
11307441|NCT03123354|FG000|Participant Flow|O3 Regional Oximeter Sensors|"All subjects are enrolled in the test group and receive O3 regional oximeter sensors during their scheduled, general cardiac catheterization procedure.~O3 regional oximeter sensors: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor"
11307442|NCT03123354|OG000|Outcome|O3 Regional Oximeter Sensors (Test Group)|"All pediatric subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.~O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor"
11307443|NCT03123354|EG000|Reported Event|O3 Regional Oximeter Sensors|"All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.~O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor"
11307444|NCT03123471|BG000|Baseline|Placebo/Apremilast|Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
11307445|NCT03123471|BG001|Baseline|Apremilast|Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
11307446|NCT03123471|BG002|Baseline|Total|Total of all reporting groups
11307447|NCT03123471|FG000|Participant Flow|Placebo/Apremilast|Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
11307448|NCT03123471|FG001|Participant Flow|Apremilast|Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
11307449|NCT03123471|OG000|Outcome|Placebo/Apremilast|Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
11307450|NCT03123471|OG001|Outcome|Apremilast|Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
11307451|NCT03123471|OG000|Outcome|Apremilast|Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase and continued to receive apremilast 30 mg BID capsules during the apremilast extension phase from week 16 to week 32.
11307452|NCT03123471|OG001|Outcome|Placebo/Apremilast|Participants received identically matching placebo capsules twice daily (BID) during the placebo-controlled phase. At week 16, participants were switched to apremilast 30 mg capsules BID during the apremilast extension treatment phase and received apremilast from week 16 to week 32.
11307453|NCT03123471|OG001|Outcome|Apremilast|Participants randomized to apremilast 30 mg capsules BID during the placebo-controlled phase and continued to receive apremilast 30 mg BID capsules from week 16 to week 32
11307454|NCT03123471|EG000|Reported Event|Placebo (Weeks 0-16)|Participants received identically matching placebo capsules twice daily during the 16-week placebo-controlled phase.
11307455|NCT03123471|EG001|Reported Event|Apremilast 30 mg (Weeks 0-16)|Participants received apremilast 30 mg capsules BID during the 16-week placebo-controlled phase.
11307456|NCT03123471|EG002|Reported Event|Placebo/Apremilast (APR Extension Phase Weeks 16-32)|Participants initially randomized to placebo capsules BID during the placebo controlled phase were switched to apremilast 30 mg capsules BID at week 16 and continued apremilast up to Week 32.
11307457|NCT03123471|EG003|Reported Event|Apremilast /Apremilast (APR Exposure Period, Weeks 0-32)|Participants received apremilast 30 mg capsules BID during the placebo-controlled phase and continued to receive apremilast 30 mg BID capsules from weeks 16 to week 32.
11307458|NCT03123471|EG004|Reported Event|Apremilast Total (APR Exposure Period, Weeks 0-32)|Participants who started apremilast 30 mg BID at any time during the study (Week 0 for participants originally randomized to apremilast or at week 16 for participants originally randomized to placebo.
11307459|NCT03123588|BG000|Baseline|Group A : Ruxolitinib and Anagrelide Placebo|Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
11307460|NCT03123588|BG001|Baseline|Group B : Anagrelide and Ruxolitinib Placebo|Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
11307461|NCT03123588|BG002|Baseline|Total|Total of all reporting groups
11307462|NCT03123588|FG000|Participant Flow|Group A : Ruxolitinib and Anagrelide Placebo|Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
11307463|NCT03123588|FG001|Participant Flow|Group B : Anagrelide and Ruxolitinib Placebo|Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
11307464|NCT03123588|OG000|Outcome|Group A : Ruxolitinib and Anagrelide Placebo|Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
11307465|NCT03123588|OG001|Outcome|Group B : Anagrelide and Ruxolitinib PLacebo|Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
11307466|NCT03123588|OG001|Outcome|Group B : Anagrelide and Ruxolitinib Placebo|Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
11307467|NCT03123588|EG000|Reported Event|Group A : Ruxolitinib and Anagrelide Placebo|Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
11307468|NCT03123588|EG001|Reported Event|Group B : Anagrelide and Ruxolitinib Placebo|Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information
11307469|NCT03123614|BG000|Baseline|Loteprednol Etabonate 0.5% Oph Gel|"Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.~Loteprednol Etabonate 0.5% Oph Gel"
11307470|NCT03123614|BG001|Baseline|Prednisolone Acetate 1% Oph Susp|"Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.~Prednisolone Acetate 1% Oph Susp"
11307471|NCT03123614|BG002|Baseline|Total|Total of all reporting groups
11307472|NCT03123614|FG000|Participant Flow|Loteprednol Etabonate 0.5% Oph Gel|"Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.~Loteprednol Etabonate 0.5% Oph Gel"
11307473|NCT03123614|FG001|Participant Flow|Prednisolone Acetate 1% Oph Susp|"Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.~Prednisolone Acetate 1% Oph Susp"
11307474|NCT03123614|OG000|Outcome|Loteprednol Etabonate 0.5% Oph Gel|"Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.~Loteprednol Etabonate 0.5% Oph Gel"
11307475|NCT03123614|OG001|Outcome|Prednisolone Acetate 1% Oph Susp|"Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.~Prednisolone Acetate 1% Oph Susp"
11307476|NCT03123614|EG000|Reported Event|Loteprednol Etabonate 0.5% Oph Gel|"Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.~Loteprednol Etabonate 0.5% Oph Gel"
11307477|NCT03123614|EG001|Reported Event|Prednisolone Acetate 1% Oph Susp|"Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.~Prednisolone Acetate 1% Oph Susp"
11307478|NCT03123848|BG000|Baseline|Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)|Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307479|NCT03123848|FG000|Participant Flow|Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)|Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307480|NCT03123848|OG000|Outcome|Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg)|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307481|NCT03123848|OG001|Outcome|Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307482|NCT03123848|OG000|Outcome|Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)|Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307483|NCT03123848|EG000|Reported Event|Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)|Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
11307484|NCT03123861|BG000|Baseline|Gabapentin|"Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.~Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively."
11307485|NCT03123861|BG001|Baseline|Placebo Oral Capsule|"Participants will take placebo for the 2 weeks after surgery.~Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively.."
11307486|NCT03123861|BG002|Baseline|Total|Total of all reporting groups
11307487|NCT03123861|FG000|Participant Flow|Gabapentin|"Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg twice a day (BID) for an additional 11 days.~Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively."
11307488|NCT03123861|FG001|Participant Flow|Placebo Oral Capsule|"Participants will take placebo for the 2 weeks after surgery.~Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively.."
11307489|NCT03123861|OG000|Outcome|Gabapentin|"Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.~Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively."
11307490|NCT03123861|OG001|Outcome|Placebo Oral Capsule|"Participants will take placebo for the 2 weeks after surgery.~Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively.."
11307491|NCT03123861|EG000|Reported Event|Gabapentin|"Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.~Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively."
11307492|NCT03123861|EG001|Reported Event|Placebo Oral Capsule|"Participants will take placebo for the 2 weeks after surgery.~Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively.."
11307493|NCT03123874|BG000|Baseline|Sterile Pump Set-up First|Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.
11307494|NCT03123874|BG001|Baseline|Mother's Own Pump Set-up First|Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
11307495|NCT03123874|BG002|Baseline|Total|Total of all reporting groups
10972040|NCT00918957|EG001|Reported Event|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
11307496|NCT03123874|FG000|Participant Flow|Sterile Pump Set-up First|Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.
11307497|NCT03123874|FG001|Participant Flow|Mother's Own Pump Set-up First|Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
11307498|NCT03123874|OG000|Outcome|Sterile Pump Set-up First|Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.
11307499|NCT03123874|OG001|Outcome|Mother's Own Pump Set-up First|Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
11307500|NCT03123874|OG000|Outcome|Sterile Pump Set-up First|"Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.~Sterile pump set-up: Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).~Mother's Own pump set-up: Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices)."
11307501|NCT03123874|OG001|Outcome|Mother's Own Pump Set-up First|"Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.~Sterile pump set-up: Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).~Mother's Own pump set-up: Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices)."
11307502|NCT03123874|OG000|Outcome|Sterile Pump Set-up First|"Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.~Sterile pump set-up: Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).~Mom's own pump set-up: Mom's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices)."
11307503|NCT03123874|OG001|Outcome|Own Pump Set-up First|"Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.~Sterile pump set-up: Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).~Mom's own pump set-up: Mom's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices)."
11307504|NCT03123874|EG000|Reported Event|Sterile Pump Set-up First|Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.
11307505|NCT03123874|EG001|Reported Event|Mother's Own Pump Set-up First|Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
11307506|NCT03123939|BG000|Baseline|CTL019|CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10^8 CTL019 transduced viable T cells (for patients > 50 kg)
11307507|NCT03123939|FG000|Participant Flow|CTL019|CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10^8 CTL019 transduced viable T cells (for patients > 50 kg)
10848522|NCT00290290|EG001|Reported Event|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
10848523|NCT00290329|BG000|Baseline|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307508|NCT03123939|OG000|Outcome|CTL019|CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10^8 CTL019 transduced viable T cells (for patients > 50 kg)
11307509|NCT03123939|EG000|Reported Event|All Subjects - CTL019|CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10^8 CTL019 transduced viable T cells (for patients > 50 kg)
11307510|NCT03124069|BG000|Baseline|F&P Nasal|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
11307511|NCT03124069|FG000|Participant Flow|F&P Nasal Mask|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
11307512|NCT03124069|OG000|Outcome|F&P Nasal|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.~."
11307513|NCT03124069|OG000|Outcome|F&P Nasal|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
11307514|NCT03124069|OG000|Outcome|F&P Nasal Mask|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
11307515|NCT03124069|EG000|Reported Event|F&P Nasal Mask|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
11307516|NCT03124108|BG000|Baseline|Elafibranor 80mg|Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.
11307517|NCT03124108|BG001|Baseline|Elafibranor 120mg|Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.
11307518|NCT03124108|BG002|Baseline|Placebo|Participants received matching placebo tablets orally once daily for 12 weeks.
11307519|NCT03124108|BG003|Baseline|Total|Total of all reporting groups
11307520|NCT03124108|FG000|Participant Flow|Elafibranor 80mg|Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.
11307521|NCT03124108|FG001|Participant Flow|Elafibranor 120mg|Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.
11307522|NCT03124108|FG002|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily for 12 weeks.
11307523|NCT03124108|OG000|Outcome|Elafibranor 80mg|Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.
11307524|NCT03124108|OG001|Outcome|Elafibranor 120mg|Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.
11307525|NCT03124108|OG002|Outcome|Placebo|Participants received matching placebo tablets orally once daily for 12 weeks.
11307526|NCT03124108|OG001|Outcome|Elafibranor 120 mg|Participants received orally a dose of 120 mg elafibranor as tablets once daily for 12 weeks.
11307527|NCT03124108|OG000|Outcome|Elafibranor 80 mg|Participants received orally a dose of 80 milligram (mg) elafibranor as tablets once daily for 12 weeks.
11307528|NCT03124108|EG000|Reported Event|Elafibranor 80mg|Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.
11307529|NCT03124108|EG001|Reported Event|Elafibranor 120mg|Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.
11307530|NCT03124108|EG002|Reported Event|Placebo|Participants received matching placebo tablets orally once daily for 12 weeks.
11307531|NCT03124121|BG000|Baseline|Golimumab Induction Therapy|Patients commencing golimumab
11307532|NCT03124121|BG001|Baseline|Golimumab Maintenance Therapy|Patients receiving golimumab maintenance therapy
11307533|NCT03124121|BG002|Baseline|Total|Total of all reporting groups
11307534|NCT03124121|FG000|Participant Flow|Golimumab Induction Therapy|Patients commencing golimumab
11307535|NCT03124121|FG001|Participant Flow|Golimumab Maintenance Therapy|Patients receiving golimumab maintenance therapy
11307536|NCT03124121|OG000|Outcome|Golimumab Induction Therapy|Patients commencing golimumab
11307537|NCT03124121|OG001|Outcome|Golimumab Maintenance Therapy|Patients receiving golimumab maintenance therapy
11307538|NCT03124121|OG000|Outcome|Induction Cohort|Patients commencing golimumab
11307539|NCT03124121|OG001|Outcome|Maintenance Cohort|Patients receiving golimumab maintenance therapy
11307540|NCT03124121|EG000|Reported Event|Golimumab Induction Therapy|Patients commencing golimumab induction
11307541|NCT03124121|EG001|Reported Event|Golimumab Maintenance Therapy|Patients receiving golimumab maintenance therapy
11307542|NCT03124199|BG000|Baseline|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
11307543|NCT03124199|FG000|Participant Flow|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
11307544|NCT03124199|OG000|Outcome|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
11307545|NCT03124199|EG000|Reported Event|Rifaximin|"Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.~Rifaximin: Rifaximin 400 mg/8 h added to the standard triple therapy"
11307546|NCT03124342|BG000|Baseline|VANDERBILT ICU RECOVERY PROGRAM (VIP)|"VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:~Nurse Practitioner In-Person Visit at the time of transfer from the ICU~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources~Performance of formal medication reconciliation at the time of transfer from the ICU~Access to a dedicated 24-hour a day, 7-day a week contact line~ICU Recovery Clinic Visit Medical Examination.~ICU Recovery Clinic Medication Reconciliation and Counseling~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist~ICU Recovery Clinic Case Management. A brief case management consultation~ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician~Directed Subspecialty Referrals"
11307547|NCT03124342|BG001|Baseline|Usual Care|Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.
11307548|NCT03124342|BG002|Baseline|Total|Total of all reporting groups
11307549|NCT03124342|FG000|Participant Flow|VANDERBILT ICU RECOVERY PROGRAM (VIP)|"VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:~Nurse Practitioner In-Person Visit at the time of transfer from the ICU~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources~Performance of formal medication reconciliation at the time of transfer from the ICU~Access to a dedicated 24-hour a day, 7-day a week contact line~ICU Recovery Clinic Visit Medical Examination.~ICU Recovery Clinic Medication Reconciliation and Counseling~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist~ICU Recovery Clinic Case Management. A brief case management consultation~ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician~Directed Subspecialty Referrals"
11307550|NCT03124342|FG001|Participant Flow|Usual Care|Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.
11307551|NCT03124342|OG000|Outcome|VANDERBILT ICU RECOVERY PROGRAM (VIP)|"VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:~Nurse Practitioner In-Person Visit at the time of transfer from the ICU~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources~Performance of formal medication reconciliation at the time of transfer from the ICU~Access to a dedicated 24-hour a day, 7-day a week contact line~ICU Recovery Clinic Visit Medical Examination.~ICU Recovery Clinic Medication Reconciliation and Counseling~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist~ICU Recovery Clinic Case Management. A brief case management consultation~ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician~Directed Subspecialty Referrals"
11307552|NCT03124342|OG001|Outcome|Usual Care|Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.
10848524|NCT00290329|BG001|Baseline|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307553|NCT03124342|OG000|Outcome|VANDERBILT ICU RECOVERY PROGRAM (VIP)|"Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention.~VANDERBILT ICU RECOVERY PROGRAM: 10-component ICU Recovery Program intervention, including:~Nurse Practitioner In-Person Visit at the time of transfer from the ICU~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources~Performance of formal medication reconciliation at the time of transfer from the ICU~Access to a dedicated 24-hour a day, 7-day a week contact line~ICU Recovery Clinic Visit Medical Examination.~ICU Recovery Clinic Medication Reconciliation and Counseling~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist~ICU Recovery Clinic Case Management. A brief case management consultation~ICU Recovery Clinic Patient Centered Consultation."
11307554|NCT03124342|EG000|Reported Event|VANDERBILT ICU RECOVERY PROGRAM (VIP)|"VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:~Nurse Practitioner In-Person Visit at the time of transfer from the ICU~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources~Performance of formal medication reconciliation at the time of transfer from the ICU~Access to a dedicated 24-hour a day, 7-day a week contact line~ICU Recovery Clinic Visit Medical Examination.~ICU Recovery Clinic Medication Reconciliation and Counseling~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist~ICU Recovery Clinic Case Management. A brief case management consultation~ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician~Directed Subspecialty Referrals"
11307555|NCT03124342|EG001|Reported Event|Usual Care|Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.
11307556|NCT03124368|BG000|Baseline|Group 1: Danicopan 100 mg TID (Sentinel)|Participants received 100 mg of danicopan TID during the Treatment Period.
11307557|NCT03124368|BG001|Baseline|Group 2: Danicopan up to 200 mg TID|Participants received not more than 200 mg of danicopan TID during the Treatment Period.
11307558|NCT03124368|BG002|Baseline|Total|Total of all reporting groups
11307559|NCT03124368|FG000|Participant Flow|Group 1: Danicopan 100 mg TID (Sentinel)|Participants received 100 milligrams (mg) of danicopan three times daily (TID) during the Treatment Period.
11307560|NCT03124368|FG001|Participant Flow|Group 2: Danicopan up to 200 mg TID|Participants received not more than 200 mg of danicopan TID during the Treatment Period.
11307561|NCT03124368|OG000|Outcome|Group 1: Danicopan 100 mg TID (Sentinel)|Participants received 100 mg of danicopan TID during the Treatment Period.
11307562|NCT03124368|OG001|Outcome|Group 2: Danicopan up to 200 mg TID|Participants received not more than 200 mg of danicopan TID during the Treatment Period.
11307563|NCT03124368|OG002|Outcome|Total|All participants who received at least 1 dose of danicopan.
11307564|NCT03124368|OG002|Outcome|Total|All participants who received at least 1 dose of Danicopan.
11307565|NCT03124368|OG000|Outcome|Group 1: Danicopan 100 mg TID|Participants received 100 mg of danicopan TID during the Treatment Period.
11307566|NCT03124368|OG001|Outcome|Group 2: Danicopan 150 mg TID|Participants received 150 mg of danicopan TID during the Treatment Period.
11307567|NCT03124368|OG002|Outcome|Group 2: Danicopan 200 mg TID|Participants received 200 mg of danicopan TID during the Treatment Period.
11307568|NCT03124368|EG000|Reported Event|Group 1: Danicopan 100 mg TID (Sentinel)|Participants received 100 mg of danicopan TID during the Treatment Period.
11307569|NCT03124368|EG001|Reported Event|Group 2: Danicopan up to 200 mg TID|Participants received not more than 200 mg of danicopan TID during the Treatment Period.
11307570|NCT03124381|BG000|Baseline|Gel-Cream + Acne Mask|Cleanser, Gel-Cream, Acne Mask
11307571|NCT03124381|BG001|Baseline|Acne Mask|Cleanser, Acne Mask
11307572|NCT03124381|BG002|Baseline|Total|Total of all reporting groups
11307573|NCT03124381|FG000|Participant Flow|Gel-Cream + Acne Mask|Cleanser, Gel-Cream, Acne Mask
11307574|NCT03124381|FG001|Participant Flow|Acne Mask|Cleanser, Acne Mask
11307575|NCT03124381|OG000|Outcome|Gel-Cream + Acne Mask|Cleanser, Gel-Cream, Acne Mask
11307576|NCT03124381|OG001|Outcome|Acne Mask|Cleanser, Acne Mask
11307577|NCT03124381|EG000|Reported Event|Gel-Cream + Acne Mask|Cleanser, Gel-Cream, Acne Mask
11307578|NCT03124381|EG001|Reported Event|Acne Mask|Cleanser, Acne Mask
11307579|NCT03124407|BG000|Baseline|Once Daily-Active|"40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin"
11307580|NCT03124407|BG001|Baseline|Once Daily-Vehicle|"20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin"
11307581|NCT03124407|BG002|Baseline|Twice Daily-Active|"40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin"
11307582|NCT03124407|BG003|Baseline|Twice Daily-Vehicle|"20 subjects receiving twice daily application of drug product vehicle (i.e. ,with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin"
11307583|NCT03124407|BG004|Baseline|Total|Total of all reporting groups
11307584|NCT03124407|FG000|Participant Flow|QD-Active|"40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307585|NCT03124407|FG001|Participant Flow|QD-Vehicle|"20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product"
11307586|NCT03124407|FG002|Participant Flow|BID-Active|"40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307587|NCT03124407|FG003|Participant Flow|BID-Vehicle|"20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product"
11307588|NCT03124407|OG000|Outcome|Once Daily-Active|"40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin"
11307589|NCT03124407|OG001|Outcome|Once Daily-Vehicle|"20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin"
11307590|NCT03124407|OG002|Outcome|Twice Daily-Active|"40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin"
11307591|NCT03124407|OG003|Outcome|Twice Daily-Vehicle|"20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin"
11307592|NCT03124407|OG000|Outcome|Once Daily-Active|"40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307593|NCT03124407|OG001|Outcome|Once Daily-Vehicle|"20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but without capsaicin"
11307594|NCT03124407|OG002|Outcome|Twice Daily-Active|"40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307595|NCT03124407|OG003|Outcome|Twice Daily-Vehicle|"20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product, but without capsaicin"
11307596|NCT03124407|EG000|Reported Event|QD-Active|"40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307597|NCT03124407|EG001|Reported Event|QD-Vehicle|"20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product"
11307598|NCT03124407|EG002|Reported Event|BID-Active|"40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee~Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin"
11307599|NCT03124407|EG003|Reported Event|BID-Vehicle|"20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee~Drug product vehicle: This is the vehicle for the active treatment drug product"
11307600|NCT03124459|BG000|Baseline|Part 1 Cohort 1|"ACE-083 150 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307601|NCT03124459|BG001|Baseline|Part 1 Cohort 2|"ACE-083 200 mg IM, (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307602|NCT03124459|BG002|Baseline|Part 1 Cohort 3|"ACE-083 240 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307603|NCT03124459|BG003|Baseline|Part 2 (Double-blind Placebo Controlled) Placebo|"Placebo once every 3 weeks for up to 9 doses~ACE-083: Part 2 - buffer solution."
11307604|NCT03124459|BG004|Baseline|Part 2 (Double-blind Placebo Controlled) ACE-083|"ACE-083 up to 250 mg IM (tibialis anterior muscle) once every 3 weeks for up to 9 doses~ACE-083 Part 2 - Recombinant fusion protein"
11307605|NCT03124459|BG005|Baseline|Part 2 (Open-label) ACE 083-03 Arm|"ACE-083 up to 250 mg IM (tibialis anterior muscle) once every 3 weeks for up to 8 doses~ACE-083 Part 2 - Recombinant fusion protein"
11307606|NCT03124459|BG006|Baseline|Total|Total of all reporting groups
11307607|NCT03124459|FG000|Participant Flow|Part 1 Cohort 1 (150 mg)|"ACE-083 150 mg intramuscular (IM; tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307608|NCT03124459|FG001|Participant Flow|Part 1 Cohort 2 (200 mg)|"ACE-083 200 mg IM, (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307609|NCT03124459|FG002|Participant Flow|Part 1 Cohort 3 (240 mg)|"ACE-083 240 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307610|NCT03124459|FG003|Participant Flow|Part 2 (Double-blind Placebo Controlled) Placebo Arm|"Placebo once every 3 weeks for up to 9 doses~ACE-083: Part 2 -buffer solution"
11307611|NCT03124459|FG004|Participant Flow|Part 2 (Double-blind Placebo Controlled) ACE-083 Arm|"ACE-083 240 mg IM (tibialis anterior muscle) once every 3 weeks for up to 9 doses~ACE-083: Part 2 - Recombinant fusion protein"
11307612|NCT03124459|FG005|Participant Flow|Part 2 (Open-label) ACE-083 Arm|"ACE-083 240 mg IM (tibialis anterior muscle) once every 3 weeks for up to 8 doses~ACE-083: Part 2 - Recombinant fusion protein"
11307613|NCT03124459|OG000|Outcome|Part 1 Cohort 1 (150 mg)|"ACE-083 150 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307614|NCT03124459|OG001|Outcome|Part 1 Cohort 2 (200 mg)|"ACE-083 200 mg IM, (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307615|NCT03124459|OG002|Outcome|Part 1 Cohort 3 (240 mg)|"ACE-083 240 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307616|NCT03124459|OG000|Outcome|Part 2 (Double-blind Placebo Controlled) Placebo Arm|"Placebo once every 3 weeks for up to 9 doses~ACE-083: Part 2 -buffer solution"
11307617|NCT03124459|OG001|Outcome|Part 2 (Double-blind Placebo Controlled) ACE-083 Arm|"ACE-083 240 mg IM (tibialis anterior muscle) once every 3 weeks for up to 9 doses~ACE-083: Part 2 - Recombinant fusion protein"
11307618|NCT03124459|EG000|Reported Event|Part 1 Cohort 1(150mg)|"ACE-083 150 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307619|NCT03124459|EG001|Reported Event|Part 1 Cohort 2 (200mg)|"ACE-083 200 mg IM, (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307620|NCT03124459|EG002|Reported Event|Part 1 Cohort 3 (250mg)|"ACE-083 up to 250 mg IM (tibialis anterior muscle), once every 3 weeks for up to 5 doses.~ACE-083: Part 1 - Recombinant fusion protein."
11307621|NCT03124459|EG003|Reported Event|Part 2 (Double-blind Placebo Controlled) Placebo Arm|"Placebo, once every 3 weeks for up to 9 doses~ACE-083:~Part 2 - Placebo: buffer solution"
11307622|NCT03124459|EG004|Reported Event|Part 2 (Double-blind Placebo Controlled) ACE-083 Arm|"ACE-083 up to 250 mg IM (tibialis anterior muscle) once every 3 weeks for up to 9 doses~ACE-083:~Part 2 - Recombinant fusion protein"
11307623|NCT03124459|EG005|Reported Event|Part 2 (Open Label)|"ACE-083 up to 250 mg IM (tibialis anterior muscle), once every 3 weeks for up to 8 doses~ACE-083: Part 1 - Recombinant fusion protein. Part 2 - Recombinant fusion protein or buffer solution."
11307624|NCT03124537|BG000|Baseline|App Control Condition|"The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month~App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307625|NCT03124537|BG001|Baseline|App Experimental Condition|"The experimental condition will set step goals and have the schedule, map, and social components for 1 month.~App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307626|NCT03124537|BG002|Baseline|Total|Total of all reporting groups
11307627|NCT03124537|FG000|Participant Flow|App Control Condition|"The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month~App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels."
11333064|NCT03507569|OG001|Outcome|RO7017773 - 30mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11307628|NCT03124537|FG001|Participant Flow|App Experimental Condition|"The experimental condition will set step goals and have the schedule, map, and social components for 1 month.~App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307629|NCT03124537|OG000|Outcome|App Control Condition|"The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month~App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307630|NCT03124537|OG001|Outcome|App Experimental Condition|"The experimental condition will set step goals and have the schedule, map, and social components for 1 month.~App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307631|NCT03124537|EG000|Reported Event|App Control Condition|"The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month~App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307632|NCT03124537|EG001|Reported Event|App Experimental Condition|"The experimental condition will set step goals and have the schedule, map, and social components for 1 month.~App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels."
11307633|NCT03124550|BG000|Baseline|Exergame Experience|Participants will use the exergame for 6 weeks, during which time game telemetry data (all interactions with the software) will be automatically logged by the system. The participants will be asked to use the game at least every other day. Caregivers will be sent an email or text message to remind them to use the system if they have not done so within three days. Utilizing two-way text messaging, an experience sampling protocol will be employed: once per week, participants will be sent brief questions probing their level of satisfaction with the exergame and their level of perceived connectedness to the community of other caregivers using the exergame.
11307634|NCT03124550|FG000|Participant Flow|Exergame Experience|Participants will use the exergame for 6 weeks, during which time game telemetry data (all interactions with the software) will be automatically logged by the system. The participants will be asked to use the game at least every other day. Caregivers will be sent an email or text message to remind them to use the system if they have not done so within three days. Utilizing two-way text messaging, an experience sampling protocol will be employed: once per week, participants will be sent brief questions probing their level of satisfaction with the exergame and their level of perceived connectedness to the community of other caregivers using the exergame.
11307635|NCT03124550|OG000|Outcome|Exergame Experience|Participants will use the exergame for 6 weeks, during which time game telemetry data (all interactions with the software) will be automatically logged by the system. The participants will be asked to use the game at least every other day. Caregivers will be sent an email or text message to remind them to use the system if they have not done so within three days. Utilizing two-way text messaging, an experience sampling protocol will be employed: once per week, participants will be sent brief questions probing their level of satisfaction with the exergame and their level of perceived connectedness to the community of other caregivers using the exergame.
11333065|NCT03507569|OG002|Outcome|RO7017773 - 75mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333066|NCT03507569|OG003|Outcome|RO7017773 - 375mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
10972041|NCT00919035|BG000|Baseline|Torisel|"Single Agent Temsorilmus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
11307636|NCT03124550|EG000|Reported Event|Exergame Experience|Participants will use the exergame for 6 weeks, during which time game telemetry data (all interactions with the software) will be automatically logged by the system. The participants will be asked to use the game at least every other day. Caregivers will be sent an email or text message to remind them to use the system if they have not done so within three days. Utilizing two-way text messaging, an experience sampling protocol will be employed: once per week, participants will be sent brief questions probing their level of satisfaction with the exergame and their level of perceived connectedness to the community of other caregivers using the exergame.
11307637|NCT03124563|BG000|Baseline|Control Group|"Participants will wear a Fitbit Zip to record their daily activity data, which was deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher."
11333067|NCT03507569|EG000|Reported Event|RO7017773 - 15mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333068|NCT03507569|EG001|Reported Event|RO7017773 - 30mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333069|NCT03507569|EG002|Reported Event|RO7017773 - 75mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
11333070|NCT03507569|EG003|Reported Event|RO7017773 - 375mg|Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand [11C]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
10972042|NCT00919035|FG000|Participant Flow|Torisel|"Single Agent Temsirolimus (Torisel®)~torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
10972043|NCT00919035|OG000|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
10972044|NCT00919035|EG000|Reported Event|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
10972045|NCT00919061|BG000|Baseline|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
11333071|NCT03508050|BG000|Baseline|Experimental|"Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation~Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation"
11333072|NCT03508050|BG001|Baseline|Control|Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333073|NCT03508050|BG002|Baseline|Total|Total of all reporting groups
11333074|NCT03508050|FG000|Participant Flow|Double Lumen Tube Clamp|"Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation~Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation"
11333075|NCT03508050|FG001|Participant Flow|Control|Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333076|NCT03508050|OG000|Outcome|Double Lumen Tube Clamp|"Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation~Clamping the Double Lumen Tube: Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation"
11333077|NCT03508050|OG001|Outcome|Control|Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333078|NCT03508050|OG000|Outcome|Double Lumen Tube Clamp|Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333079|NCT03508050|EG000|Reported Event|Double Lumen Tube Clamp|Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333080|NCT03508050|EG001|Reported Event|Control|Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
11333081|NCT03508609|BG000|Baseline|Autologous CD34 Cells|"Open label active treatment arm. Subjects receive autologous CD34 cells.~CLBS16: GCSF-mobilized autologous CD34 cells"
11333082|NCT03508609|FG000|Participant Flow|Autologous CD34 Cells|"Open label active treatment arm. Subjects receive autologous CD34 cells.~CLBS16: GCSF-mobilized autologous CD34 cells"
11333083|NCT03508609|OG000|Outcome|Autologous CD34 Cells|"Open label active treatment arm. Subjects receive autologous CD34 cells.~CLBS16: GCSF-mobilized autologous CD34 cells"
11333084|NCT03508609|EG000|Reported Event|Autologous CD34 Cells|"Open label active treatment arm. Subjects receive autologous CD34 cells.~CLBS16: GCSF-mobilized autologous CD34 cells"
11307638|NCT03124563|BG001|Baseline|Implementation Intention Condition|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire."
11307639|NCT03124563|BG002|Baseline|Total|Total of all reporting groups
11307640|NCT03124563|FG000|Participant Flow|Control Group|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher."
11307641|NCT03124563|FG001|Participant Flow|Implementation Intention Condition|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire."
11307642|NCT03124563|OG000|Outcome|Control Group|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher."
11307643|NCT03124563|OG001|Outcome|Implementation Intention Condition|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire."
11307644|NCT03124563|EG000|Reported Event|Control Group|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.~Assigned Intervention - Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher."
11307645|NCT03124563|EG001|Reported Event|Implementation Intention Condition|"Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.~Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire."
11307646|NCT03124602|BG000|Baseline|Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls|All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
11307647|NCT03124602|FG000|Participant Flow|Noninvasive Red Diamond Disposable Pulse Oximeter Sensor|All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
11307648|NCT03124602|OG000|Outcome|Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls|All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
11307649|NCT03124602|EG000|Reported Event|Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls|All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
11307650|NCT03124693|BG000|Baseline|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
11307651|NCT03124693|FG000|Participant Flow|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
11307652|NCT03124693|OG000|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
11307653|NCT03124693|EG000|Reported Event|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
11307654|NCT03124758|BG000|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
11307655|NCT03124758|FG000|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
11307656|NCT03124758|OG000|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
11307657|NCT03124758|EG000|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
11307658|NCT03124771|BG000|Baseline|Rainbow Resposable Adhesive Sensors|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
11307659|NCT03124771|FG000|Participant Flow|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
11307660|NCT03124771|OG000|Outcome|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
11307661|NCT03124771|EG000|Reported Event|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
11307662|NCT03124784|BG000|Baseline|RD Disposable Sensors|"All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors~RD Disposable Sensors: Noninvasive pulse oximeter sensor"
11307663|NCT03124784|FG000|Participant Flow|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
11307664|NCT03124784|OG000|Outcome|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
11307665|NCT03124784|EG000|Reported Event|RD Disposable Sensors|All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
11307666|NCT03124797|BG000|Baseline|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
11307667|NCT03124797|FG000|Participant Flow|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
11307668|NCT03124797|OG000|Outcome|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
11307669|NCT03124797|EG000|Reported Event|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
11307670|NCT03124823|BG000|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
11307671|NCT03124823|FG000|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
11307672|NCT03124823|OG000|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
11307673|NCT03124823|EG000|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
11307674|NCT03124836|BG000|Baseline|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
11307675|NCT03124836|FG000|Participant Flow|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
11307676|NCT03124836|OG000|Outcome|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
11307677|NCT03124836|EG000|Reported Event|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor~Pulse Oximeter Sensor"
11307678|NCT03124901|BG000|Baseline|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307679|NCT03124901|FG000|Participant Flow|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307680|NCT03124901|OG000|Outcome|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307681|NCT03124901|EG000|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307682|NCT03124927|BG000|Baseline|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307683|NCT03124927|FG000|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307684|NCT03124927|OG000|Outcome|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307685|NCT03124927|EG000|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
11307686|NCT03124966|BG000|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
11307687|NCT03124966|FG000|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
11307688|NCT03124966|OG000|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
11307689|NCT03124966|EG000|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
11307690|NCT03124979|BG000|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
11307691|NCT03124979|FG000|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
11307692|NCT03124979|OG000|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
11307693|NCT03124979|EG000|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
11307694|NCT03125005|BG000|Baseline|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
11307695|NCT03125005|FG000|Participant Flow|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
11307696|NCT03125005|OG000|Outcome|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
11307697|NCT03125005|EG000|Reported Event|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
11307698|NCT03125018|BG000|Baseline|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
11307699|NCT03125018|FG000|Participant Flow|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
11307700|NCT03125018|OG000|Outcome|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
11307701|NCT03125018|EG000|Reported Event|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
11307702|NCT03125031|BG000|Baseline|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors).
11307703|NCT03125031|FG000|Participant Flow|Rainbow Adhesive Adult/Pediatric Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
11307704|NCT03125031|FG001|Participant Flow|Rainbow Adhesive Adult/Neonatal Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
11307705|NCT03125031|OG000|Outcome|Group-Sensor 1|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
11307706|NCT03125031|OG001|Outcome|Group-Sensor 2|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
11307707|NCT03125031|EG000|Reported Event|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal).
11307708|NCT03125200|BG000|Baseline|Part 1: Dose 30μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307709|NCT03125200|BG001|Baseline|Part 1: Dose 60μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307710|NCT03125200|BG002|Baseline|Part 1: Dose 120μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307711|NCT03125200|BG003|Baseline|Part 1: Dose 150μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307712|NCT03125200|BG004|Baseline|Part 1: Dose 180μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307713|NCT03125200|BG005|Baseline|Part 1: Dose 210μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307714|NCT03125200|BG006|Baseline|Part 1: Dose 240μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307715|NCT03125200|BG007|Baseline|Total|Total of all reporting groups
11307716|NCT03125200|FG000|Participant Flow|Part 1: Dose 30μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307717|NCT03125200|FG001|Participant Flow|Part 1: Dose 60μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307718|NCT03125200|FG002|Participant Flow|Part 1: Dose 120μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307719|NCT03125200|FG003|Participant Flow|Part 1: Dose 150μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307720|NCT03125200|FG004|Participant Flow|Part 1: Dose 180μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307721|NCT03125200|FG005|Participant Flow|Part 1: Dose 210μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307722|NCT03125200|FG006|Participant Flow|Part 1: Dose 240μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307723|NCT03125200|OG000|Outcome|Part 1: Dose 30μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307724|NCT03125200|OG001|Outcome|Part 1: Dose 60μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307725|NCT03125200|OG002|Outcome|Part 1: Dose 120μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307726|NCT03125200|OG003|Outcome|Part 1: Dose 150μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307727|NCT03125200|OG004|Outcome|Part 1: Dose 180μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307728|NCT03125200|OG005|Outcome|Part 1: Dose 210μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307729|NCT03125200|OG006|Outcome|Part 1: Dose 240μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307730|NCT03125200|OG005|Outcome|Part 1: Dose 210μg/kg|Dose-escalation part of the study. Participants received ADCT-502 as a 210μg/kg dose.
11307731|NCT03125200|OG003|Outcome|Part 1: Dose 150μg/kg|Dose-escalation part of the study. Participants received ADCT-502 as a 150μg/kg dose.
11307732|NCT03125200|OG004|Outcome|Part 1: Dose 180μg/kg|Dose-escalation part of the study. Participants received ADCT-502 as a 180μg/kg dose.
11307733|NCT03125200|EG000|Reported Event|Part 1: Dose 30μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307734|NCT03125200|EG001|Reported Event|Part 1: Dose 60μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307735|NCT03125200|EG002|Reported Event|Part 1: Dose 120μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307736|NCT03125200|EG003|Reported Event|Part 1: Dose 150μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307737|NCT03125200|EG004|Reported Event|Part 1: Dose 180μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307738|NCT03125200|EG005|Reported Event|Part 1: Dose 210μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307739|NCT03125200|EG006|Reported Event|Part 1: Dose 240μg/kg|Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks.
11307740|NCT03125226|BG000|Baseline|Supportive Care (TracelT Hydrogel)|"Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.~Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection"
11307741|NCT03125226|FG000|Participant Flow|Supportive Care (TracelT Hydrogel)|"Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.~Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection"
11307742|NCT03125226|OG000|Outcome|Supportive Care (TracelT Hydrogel)|"Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.~Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection"
11307743|NCT03125226|EG000|Reported Event|Supportive Care (TracelT Hydrogel)|"Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.~Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection"
11307744|NCT03125395|BG000|Baseline|LUM/IVA|LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
11307745|NCT03125395|FG000|Participant Flow|LUM/IVA|LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
11307746|NCT03125395|OG000|Outcome|LUM/IVA|LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
11307747|NCT03125395|EG000|Reported Event|LUM/IVA|LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
11307748|NCT03125629|BG000|Baseline|Total Participants|"Baseline information reflects participation of the individual human participants. Individual human participants are present in multiple assessment groups (arms or cohorts), and to avoid over-representation of those participants, data is not reported by group."
11307749|NCT03125629|FG000|Participant Flow|Total Participant Flow|"Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups (arms or cohorts)."
11307750|NCT03125629|OG000|Outcome|18F-FDG PET/CT Scan|"Participants will undergo a PET/CT scan with radiolabel 18F-FDG.~F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner."
11307751|NCT03125629|OG001|Outcome|18F-FDG PET/MRI Scan|"Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.~F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner."
11307752|NCT03125629|OG002|Outcome|68Ga-DOTA-TATE PET/CT Scan|"Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.~Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner."
11307753|NCT03125629|OG003|Outcome|68Ga-DOTA-TATE PET/MRI Scan|"Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.~Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner."
11307754|NCT03125629|OG000|Outcome|18-FDG PET/CT and PET/MRI|PET/CT and PET/MRI scans were conducted using radiotracer 18-FDG.
11307755|NCT03125629|OG001|Outcome|68Ga DOTA-TATE PET/CT and PET/MRI|PET/CT and PET/MRI scans were conducted using radiotracer 68Ga DOTA-TATE.
11307756|NCT03125629|EG000|Reported Event|18F-FDG PET/CT Scan|"Participants will undergo a PET/CT scan with radiolabel 18F-FDG.~F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner."
11307757|NCT03125629|EG001|Reported Event|18F-FDG PET/MRI Scan|"Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.~F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner."
11307758|NCT03125629|EG002|Reported Event|68Ga-DOTA-TATE PET/CT Scan|"Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.~Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner."
11307759|NCT03125629|EG003|Reported Event|68Ga-DOTA-TATE PET/MRI Scan|"Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.~Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging~Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner."
11307760|NCT03125915|BG000|Baseline|CHTC as Usual|"Participants receive couples HIV testing and counseling following the CDC approved protocol.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307761|NCT03125915|BG001|Baseline|CHTC + Communication Skills Videos|"The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307762|NCT03125915|BG002|Baseline|CHTC + Substance Use Module|"The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307763|NCT03125915|BG003|Baseline|CHTC + Video + Substance Use Module|"The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307764|NCT03125915|BG004|Baseline|Total|Total of all reporting groups
11307765|NCT03125915|FG000|Participant Flow|CHTC as Usual|"Participants receive couples HIV testing and counseling following the CDC approved protocol.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307766|NCT03125915|FG001|Participant Flow|CHTC + Communication Skills Videos|"The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307767|NCT03125915|FG002|Participant Flow|CHTC + Substance Use Module|"The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307768|NCT03125915|FG003|Participant Flow|CHTC + Video + Substance Use Module|"The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307769|NCT03125915|OG000|Outcome|CHTC as Usual|"Participants receive couples HIV testing and counseling following the CDC approved protocol.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307770|NCT03125915|OG001|Outcome|CHTC + Communication Skills Videos|"The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307771|NCT03125915|OG002|Outcome|CHTC + Substance Use Module|"The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307772|NCT03125915|OG003|Outcome|CHTC + Video + Substance Use Module|"The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307773|NCT03125915|EG000|Reported Event|CHTC as Usual|"Participants receive couples HIV testing and counseling following the CDC approved protocol.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307774|NCT03125915|EG001|Reported Event|CHTC + Communication Skills Videos|"The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307775|NCT03125915|EG002|Reported Event|CHTC + Substance Use Module|"The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307776|NCT03125915|EG003|Reported Event|CHTC + Video + Substance Use Module|"The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.~Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.~substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.~Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol."
11307777|NCT03125941|BG000|Baseline|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307778|NCT03125941|BG001|Baseline|Dexamethasone 24 mg|"Dexamethasone 24 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307779|NCT03125941|BG002|Baseline|Total|Total of all reporting groups
11307780|NCT03125941|FG000|Participant Flow|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
10848525|NCT00290329|BG002|Baseline|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307781|NCT03125941|FG001|Participant Flow|Dexamethasone 24 mg|"Dexamethasone 24 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307782|NCT03125941|OG000|Outcome|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307783|NCT03125941|OG001|Outcome|Dexamethasone 24 mg|"Dexamethasone 24 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307784|NCT03125941|EG000|Reported Event|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307785|NCT03125941|EG001|Reported Event|Dexamethasone 24 mg|"Dexamethasone 24 mg pre-operative~Dexamethasone: pre-operative intravenous administration"
11307786|NCT03126227|BG000|Baseline|AR101 Powder Provided in Capsules|"Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol~AR101: AR101 powder provided in capsules"
11307787|NCT03126227|BG001|Baseline|Placebo Powder|"Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.~Placebo: Placebo powder provided in capsules"
11307788|NCT03126227|BG002|Baseline|Total|Total of all reporting groups
11307789|NCT03126227|FG000|Participant Flow|AR101 Powder Provided in Capsules|"Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol~AR101: AR101 powder provided in capsules"
11307790|NCT03126227|FG001|Participant Flow|Placebo Powder|"Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.~Placebo: Placebo powder provided in capsules"
10848526|NCT00290329|BG003|Baseline|Total|Total of all reporting groups
11307791|NCT03126227|OG000|Outcome|AR101 Powder Provided in Capsules|"Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol~AR101: AR101 powder provided in capsules"
11307792|NCT03126227|OG001|Outcome|Placebo Powder|"Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.~Placebo: Placebo powder provided in capsules"
11307793|NCT03126227|EG000|Reported Event|AR101 Powder Provided in Capsules|"Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol~AR101: AR101 powder provided in capsules"
11307794|NCT03126227|EG001|Reported Event|Placebo Powder|"Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.~Placebo: Placebo powder provided in capsules"
11307795|NCT03126344|BG000|Baseline|King Vision Video Laryngoscope|King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
11307796|NCT03126344|BG001|Baseline|McGrath MAC Video Laryngoscope|McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
11307797|NCT03126344|BG002|Baseline|Macintosh|Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
11307798|NCT03126344|BG003|Baseline|Total|Total of all reporting groups
11307799|NCT03126344|FG000|Participant Flow|King Vision Video Laryngoscope|King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
11307800|NCT03126344|FG001|Participant Flow|McGrath MAC Video Laryngoscope|McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
10848527|NCT00290329|FG000|Participant Flow|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
10972046|NCT00919061|FG000|Participant Flow|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
11307801|NCT03126344|FG002|Participant Flow|Macintosh|Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
11307802|NCT03126344|OG000|Outcome|King Vision Video Laryngoscope|King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
11307803|NCT03126344|OG001|Outcome|McGrath MAC Video Laryngoscope|McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
11307804|NCT03126344|OG002|Outcome|Macintosh|Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
11307805|NCT03126344|EG000|Reported Event|King Vision Video Laryngoscope|King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
11307806|NCT03126344|EG001|Reported Event|McGrath MAC Video Laryngoscope|McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
11307807|NCT03126344|EG002|Reported Event|Macintosh|Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
11307808|NCT03126370|BG000|Baseline|TAF With a Boosted PI and LDV/SOF|"Subjects who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease inhibitor for HIV treatment will continue to take their prescribed treatment for 12 weeks after enrollment.~Subjects will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide (TAF) 25 mg/emtricitabine (FTC) 200 mg (Descovy) with a boosted protease inhibitor for the next 12 weeks.~After taking TAF/FTC for 12 weeks, subjects will then start taking ledipasvir 90mg/sofosbuvir 400mg (Harvoni) in combination with TAF/FTC and a boosted protease inhibitor for 4 weeks.~Subjects will then return to taking TAF/FTC with a boosted protease inhibitor for the final 12 weeks of the study.~TDF with a boosted protease inhibitor: Subjects who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease"
11307809|NCT03126370|FG000|Participant Flow|TAF With a Boosted PI and LDV/SOF|"Subjects who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease inhibitor for HIV treatment will continue to take their prescribed treatment for 12 weeks after enrollment.~Subjects will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide (TAF) 25 mg/emtricitabine (FTC) 200 mg (Descovy) with a boosted protease inhibitor for the next 12 weeks.~After taking TAF/FTC for 12 weeks, subjects will then start taking ledipasvir 90mg/sofosbuvir 400mg (Harvoni) in combination with TAF/FTC and a boosted protease inhibitor for 4 weeks.~Subjects will then return to taking TAF/FTC with a boosted protease inhibitor for the final 12 weeks of the study.~TDF with a boosted protease inhibitor: Subjects who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease"
11307810|NCT03126370|OG000|Outcome|TDF With a Boosted PI|Tenofovir disoproxil fumarate with a boosted protease inhibitor
11307811|NCT03126370|OG001|Outcome|TAF With a Boosted PI|Tenofovir alafenamide with a boosted protease inhibitor
11307812|NCT03126370|OG002|Outcome|TAF With a Boosted PI and LDV/SOF|Tenofovir alafenamide with a boosted protease inhibitor and ledipasvir/sofosbuvir
11307813|NCT03126370|EG000|Reported Event|TDF With a Boosted PI|Tenofovir disoproxil fumarate with a boosted protease inhibitor
11307814|NCT03126370|EG001|Reported Event|TAF With a Boosted PI|Tenofovir alafenamide with a boosted protease inhibitor
11307815|NCT03126370|EG002|Reported Event|TAF With a Boosted PI and LDV/SOF|Tenofovir alafenamide with a boosted protease inhibitor and ledipasvir/sofosbuvir
11307816|NCT03126448|BG000|Baseline|Group 1: Closed Index Fractures|"Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307817|NCT03126448|BG001|Baseline|Group 2: Hardware Removal From Healed Fractures|"Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307818|NCT03126448|BG002|Baseline|Group 3: Index Treatment of Fracture Nonunions|"Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307819|NCT03126448|BG003|Baseline|Total|Total of all reporting groups
11307820|NCT03126448|FG000|Participant Flow|Group 1: Closed Index Fractures|"Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307821|NCT03126448|FG001|Participant Flow|Group 2: Hardware Removal From Healed Fractures|"Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307822|NCT03126448|FG002|Participant Flow|Group 3: Index Treatment of Fracture Nonunions|"Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307823|NCT03126448|OG000|Outcome|Group 1: Closed Index Fractures|"Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307824|NCT03126448|OG001|Outcome|Group 2: Hardware Removal From Healed Fractures|"Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307825|NCT03126448|OG002|Outcome|Group 3: Index Treatment of Fracture Nonunions|"Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
10848528|NCT00290329|FG001|Participant Flow|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307826|NCT03126448|EG000|Reported Event|Group 1: Closed Index Fractures|"Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307827|NCT03126448|EG001|Reported Event|Group 2: Hardware Removal From Healed Fractures|"Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11307828|NCT03126448|EG002|Reported Event|Group 3: Index Treatment of Fracture Nonunions|"Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays.~Highly Sensitive Assays: Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results."
11333085|NCT03508661|BG000|Baseline|SPIN-SSLED Program|SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 &7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
10848529|NCT00290329|FG002|Participant Flow|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307848|NCT03126682|BG000|Baseline|Wellbutrin During ECT 1|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307849|NCT03126682|BG001|Baseline|Wellbutrin During ECT 2|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2.~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307850|NCT03126682|BG002|Baseline|Total|Total of all reporting groups
11307851|NCT03126682|FG000|Participant Flow|Wellbutrin During ECT 1|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307852|NCT03126682|FG001|Participant Flow|Wellbutrin During ECT 2|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2.~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307853|NCT03126682|OG000|Outcome|Wellbutrin During ECT 1|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307854|NCT03126682|OG001|Outcome|Wellbutrin During ECT 2|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2.~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307855|NCT03126682|EG000|Reported Event|Wellbutrin During ECT 1|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307856|NCT03126682|EG001|Reported Event|Wellbutrin During ECT 2|"Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2.~Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet"
11307857|NCT03126760|BG000|Baseline|Acthar Gel|Participants receive Acthar Gel under the skin once a day for 14 consecutive days
11307858|NCT03126760|BG001|Baseline|Placebo|Participants receive Placebo under the skin once a day for 14 consecutive days
11307859|NCT03126760|BG002|Baseline|Total|Total of all reporting groups
11307860|NCT03126760|FG000|Participant Flow|Acthar Gel|Participants receive Acthar Gel under the skin once a day for 14 consecutive days
11307861|NCT03126760|FG001|Participant Flow|Placebo|Participants receive Placebo under the skin once a day for 14 consecutive days
11307862|NCT03126760|OG000|Outcome|Acthar Gel|Participants receive Acthar Gel under the skin once a day for 14 consecutive days
11307863|NCT03126760|OG001|Outcome|Placebo|Participants receive Placebo under the skin once a day for 14 consecutive days
11307864|NCT03126760|EG000|Reported Event|Acthar Gel|Participants receive Acthar Gel under the skin once a day for 14 consecutive days
11307865|NCT03126760|EG001|Reported Event|Placebo|Participants receive Placebo under the skin once a day for 14 consecutive days
11307866|NCT03126786|BG000|Baseline|Active|"Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~SC CLS-TA: SC CLS-TA [40 mg/mL]"
11307867|NCT03126786|BG001|Baseline|Control|"Treatment will consist of IVT aflibercept injection followed by a sham SC procedure~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~Sham SC: sham SC"
11307868|NCT03126786|BG002|Baseline|Total|Total of all reporting groups
11307869|NCT03126786|FG000|Participant Flow|Active|"Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~SC CLS-TA: SC CLS-TA [40 mg/mL]"
11307870|NCT03126786|FG001|Participant Flow|Control|"Treatment will consist of IVT aflibercept injection followed by a sham SC procedure~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~Sham SC: sham SC"
11307871|NCT03126786|OG000|Outcome|Active|"Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~SC CLS-TA: SC CLS-TA [40 mg/mL]"
11307872|NCT03126786|OG001|Outcome|Control|"Treatment will consist of IVT aflibercept injection followed by a sham SC procedure~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~Sham SC: sham SC"
11307873|NCT03126786|EG000|Reported Event|Active|"Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~SC CLS-TA: SC CLS-TA [40 mg/mL]"
11307874|NCT03126786|EG001|Reported Event|Control|"Treatment will consist of IVT aflibercept injection followed by a sham SC procedure~IVT aflibercept: IVT aflibercept [2 mg (0.05 mL)]~Sham SC: sham SC"
11307875|NCT03127228|BG000|Baseline|Standard Mechanical Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy"
11307876|NCT03127228|BG001|Baseline|Er:YAG Laser-assisted Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy~Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy"
11307877|NCT03127228|BG002|Baseline|Total|Total of all reporting groups
11307878|NCT03127228|FG000|Participant Flow|Standard Mechanical Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy"
11307879|NCT03127228|FG001|Participant Flow|Er:YAG Laser-assisted Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy~Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy"
11307880|NCT03127228|OG000|Outcome|Standard Mechanical Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy"
11307881|NCT03127228|OG001|Outcome|Er:YAG Laser-assisted Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy~Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy"
11307882|NCT03127228|EG000|Reported Event|Standard Mechanical Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy"
11307883|NCT03127228|EG001|Reported Event|Er:YAG Laser-assisted Debridement|"Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.~Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy~Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy"
11307884|NCT03127358|BG000|Baseline|AiCure App|Direct Observed Therapy via the AiCure app (a-DOT)
11307885|NCT03127358|BG001|Baseline|Treatment As Usual|Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
11307886|NCT03127358|BG002|Baseline|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming."
11307887|NCT03127358|BG003|Baseline|Total|Total of all reporting groups
11307888|NCT03127358|FG000|Participant Flow|AiCure App|"Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.~AiCure: Smartphone App"
11307889|NCT03127358|FG001|Participant Flow|Treatment As Usual|Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
11307890|NCT03127358|FG002|Participant Flow|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming."
11307891|NCT03127358|OG000|Outcome|AiCure App|"Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.~AiCure: Smartphone App"
11307892|NCT03127358|OG001|Outcome|Treatment As Usual|Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
11307893|NCT03127358|OG002|Outcome|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming."
11307894|NCT03127358|OG000|Outcome|AiCure App|"Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.~AiCure: Smartphone App~3 out 3 patients completed HCV treatment."
11307895|NCT03127358|OG001|Outcome|Treatment As Usual|"Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.~3 out 3 patients completed HCV treatment."
11307896|NCT03127358|OG002|Outcome|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming.~5 out 5 patients completed HCV treatment."
11307897|NCT03127358|OG000|Outcome|AiCure App|"Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.~AiCure: Smartphone App~3 out 3 patients achieved SVR."
11307898|NCT03127358|OG001|Outcome|Treatment As Usual|"Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.~3 out 3 patients achieved SVR."
11307899|NCT03127358|OG002|Outcome|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming.~5 out 5 patients achieved SVR."
11307900|NCT03127358|EG000|Reported Event|AiCure App|"Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.~AiCure: Smartphone App"
10972047|NCT00919061|OG000|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
11307901|NCT03127358|EG001|Reported Event|Treatment As Usual|Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
11307902|NCT03127358|EG002|Reported Event|AiCure With Gamification|"Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.~AiCure with gamification: Smartphone App with gaming."
11307903|NCT03127384|BG000|Baseline|Split-face: Treatment/No-treatment Control|All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
11307904|NCT03127384|FG000|Participant Flow|Split-face: Treatment/No-treatment Control|All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
11307905|NCT03127384|OG000|Outcome|Split-face: Treatment/No-treatment Control|All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
11307906|NCT03127384|OG000|Outcome|No-treatment Control|No-treatment control: No-treatment control
11307907|NCT03127384|OG001|Outcome|Treatment|"Intradermal injection Restylane Lidocaine~Restylane Lidocaine: Hyaluronic acid based filler"
11307908|NCT03127384|EG000|Reported Event|Split-face: Treatment/No-treatment Control|All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
11307909|NCT03127514|BG000|Baseline|Placebo|"Placebo administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~Placebo: Matching Placebo Comparator"
11307910|NCT03127514|BG001|Baseline|AMX0035|"AMX0035 administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~AMX0035: AMX0035"
11307911|NCT03127514|BG002|Baseline|Total|Total of all reporting groups
11307912|NCT03127514|FG000|Participant Flow|Placebo|"Placebo administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~Placebo: Matching Placebo Comparator"
11307913|NCT03127514|FG001|Participant Flow|AMX0035|"AMX0035 administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~AMX0035: AMX0035"
11307914|NCT03127514|OG000|Outcome|Placebo|"Placebo administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~Placebo: Matching Placebo Comparator"
11307915|NCT03127514|OG001|Outcome|AMX0035|"AMX0035 administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~AMX0035: AMX0035"
11307916|NCT03127514|EG000|Reported Event|Placebo|"Placebo administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~Placebo: Matching Placebo Comparator"
11307917|NCT03127514|EG001|Reported Event|AMX0035|"AMX0035 administered by mouth or via feeding tube for 24 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating~AMX0035: AMX0035"
11307918|NCT03127644|BG000|Baseline|ZS 5 g TID|ZS suspension was administered 5 g orally TID for 48 hours.
11307919|NCT03127644|BG001|Baseline|ZS 10 g TID|ZS suspension was administered 10 g orally TID for 48 hours.
11307920|NCT03127644|BG002|Baseline|Placebo TID|Placebo suspension was administered orally TID for 48 hours.
11307921|NCT03127644|BG003|Baseline|Total|Total of all reporting groups
11307922|NCT03127644|FG000|Participant Flow|ZS 5 g TID|ZS suspension was administered 5 g orally TID for 48 hours.
11307923|NCT03127644|FG001|Participant Flow|ZS 10 g TID|ZS suspension was administered 10 g orally TID for 48 hours.
11307924|NCT03127644|FG002|Participant Flow|Placebo TID|Placebo suspension was administered orally TID for 48 hours.
11307925|NCT03127644|OG000|Outcome|ZS 5 g TID|ZS suspension was administered 5 g orally TID for 48 hours.
11307926|NCT03127644|OG001|Outcome|ZS 10 g TID|ZS suspension was administered 10 g orally TID for 48 hours.
11307927|NCT03127644|OG002|Outcome|Placebo TID|Placebo suspension was administered orally TID for 48 hours.
11307928|NCT03127644|OG001|Outcome|ZS 10g TID|ZS suspension was administered 10 g orally TID for 48 hours.
11307929|NCT03127644|OG000|Outcome|ZS 5g TID|ZS suspension was administered 5 g orally TID for 48 hours.
11307930|NCT03127644|EG000|Reported Event|ZS 5 g TID|ZS suspension was administered 5 g orally TID for 48 hours.
11307931|NCT03127644|EG001|Reported Event|ZS 10 g TID|ZS suspension was administered 10 g orally TID for 48 hours.
11307932|NCT03127644|EG002|Reported Event|Placebo TID|Placebo suspension was administered orally TID for 48 hours.
10848530|NCT00290329|OG000|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307933|NCT03127943|BG000|Baseline|All Study Participants|Participants who were to receive either Buffered 1% lidocaine or Non-Buffered 2% Lidocaine
11307934|NCT03127943|FG000|Participant Flow|Buffered 1% Lidocaine, Then Non-Buffered 1% Lidocaine|At each treatment visit participants were injected to block the Inferior alveolar, Lingual and Buccal nerves.
11307935|NCT03127943|FG001|Participant Flow|Non-Buffered 1% Lidocaine, Then Buffered 1% Lidocaine|At each treatment visit participants were injected to block the Inferior alveolar, Lingual and Buccal nerves.
11307936|NCT03127943|OG000|Outcome|Buffered 1% Lidocaine, Then Non-Buffered 1% Lidocaine|All subjects who received Buffered 1% Lidocaine
11307937|NCT03127943|OG001|Outcome|Non-buffered 1% Lididocaine, the Buffered 1% Lidocaine|All subjects who received Non_buffered Lidocaine
11307938|NCT03127943|EG000|Reported Event|Buffered 1% Lidocaine|Each subject was injected intraorally with Buffered 1% Lidocaine (with 1/100,00 epinephrine) to block the Inferior alveolar, Lingual, and Buccal nerves. Mandibular molar and canine tested for pulpal anesthesia.
11307939|NCT03127943|EG001|Reported Event|Non-Buffered 1% Lidocaine|Each subject was injected intraorally with Non-buffered 1% Lidocaine (with 1/100,00 epinephrine) to block the Inferior alveolar, Lingual and Buccal nerves. Mandibular molar and canine tested for pulpal anesthesia.
11307940|NCT03127956|BG000|Baseline|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
11307941|NCT03127956|FG000|Participant Flow|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
11307942|NCT03127956|OG000|Outcome|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
11307943|NCT03127956|EG000|Reported Event|Olumacostat Glasaretil Gel, 5.0%|Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
11307944|NCT03128008|BG000|Baseline|Carboplatin/Paclitaxel With Radiation Therapy|"Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.~Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.~Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy."
11307945|NCT03128008|FG000|Participant Flow|Carboplatin/Paclitaxel With Radiation Therapy|Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
11307946|NCT03128008|OG000|Outcome|Carboplatin/Paclitaxel With Radiation Therapy|Eligible participants will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
11307947|NCT03128008|OG000|Outcome|Carboplatin/Paclitaxel With Radiation Therapy|"Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.~Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.~Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.~Daily hyperfractionated radiation therapy: All subjects will receive 6 fractions(2Gy per fraction) of radiation therapy weekly. All subjects will complete an interim PET-CT after 48Gy-54Gy of RT . Subjects with a complete response on PET will complete RT at 60 Gy; subjects who have residual disease on interim PET and meet strict planning constraints eligibility will proceed to boost RT for a total RT dose of 72Gy. Interim PET-CT response will be measured using PERCIST criteria."
11307948|NCT03128008|EG000|Reported Event|Carboplatin/Paclitaxel With Radiation Therapy|"Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.~Carboplatin: Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.~Paclitaxel: Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy."
11307949|NCT03128086|BG000|Baseline|Protocol-directed Weaning|"A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated.~Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)"
11307950|NCT03128086|BG001|Baseline|Conventional Weaning|A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
11307951|NCT03128086|BG002|Baseline|Total|Total of all reporting groups
11307952|NCT03128086|FG000|Participant Flow|Protocol-directed Weaning|"A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated.~Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)"
11307953|NCT03128086|FG001|Participant Flow|Conventional Weaning|A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
11307954|NCT03128086|OG000|Outcome|Protocol-directed Weaning|"A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated.~Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)"
11307955|NCT03128086|OG001|Outcome|Conventional Weaning|A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
11307956|NCT03128086|EG000|Reported Event|Protocol-directed Weaning|"A protocol-directed weaning in neurological patients undergoing mechanical ventilation: performing a spontaneous breathing trial through a T-tube and after that to assess the patient's capacity to maintain airway. In case of reach a score the patient will extubated.~Protocol-directed weaning: A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)"
11307957|NCT03128086|EG001|Reported Event|Conventional Weaning|A control group of weaning from mechanical ventilation according to the usual procedure: performing a spontaneous breathing trial through a T-tube and then extubation if the patient success this trial.
11307958|NCT03128099|BG000|Baseline|Low Dose VR Social Skills Training|"In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.~Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention"
11307959|NCT03128099|BG001|Baseline|High Dose VR Social Skills Training|"In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.~Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention"
11307960|NCT03128099|BG002|Baseline|Healthy Control Participants|Control participants were recruited to provide normative data
11307961|NCT03128099|BG003|Baseline|Total|Total of all reporting groups
11307962|NCT03128099|FG000|Participant Flow|Low Dose VR Social Skills Training|"In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.~Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL)."
11307963|NCT03128099|FG001|Participant Flow|High Dose VR Social Skills Training|"In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.~Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL)."
11307964|NCT03128099|FG002|Participant Flow|Healthy Control Participants|Control participants were recruited to obtain normative data
11307965|NCT03128099|OG000|Outcome|Low Dose VR Social Skills Training|"In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.~Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention"
11307966|NCT03128099|EG000|Reported Event|Low Dose VR Social Skills Training|"In the low dose condition, participants play the video game for 1 hour per session. This is a behavioral intervention study. The intervention is playing the social skills VR game to exercise social skills with avatar characters.~VR social skills training: Participants play a VR video game involving social interactions with various characters (avatars) at a bus stop, a cafeteria and a store. The games become progressively more complex as the task performance improves. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention"
11307967|NCT03128099|EG001|Reported Event|High Dose VR Social Skills Training|"In the high dose condition, participants play the same video game twice per session (2 hours). This is a behavioral intervention study. The intervention is playing the social skills VR game to exercise social skills with avatar characters.~VR social skills training: Participants play a VR video game involving social interactions with various characters (avatars) at a bus stop, a cafeteria and a store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention.~Please note that because of the burdensome nature of playing this video game for 2 hours, no participant completed this condition. 4 started and completed 1 hour per session ( equivalent to the low dose condition) but they did not play 2 hours per session."
11307968|NCT03128099|EG002|Reported Event|Healthy Controls|Control participants did not undergo training (no intervention). They were only tested to establish normative baseline test scores.
11307969|NCT03128307|BG000|Baseline|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
11307970|NCT03128307|FG000|Participant Flow|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
11307971|NCT03128307|OG000|Outcome|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
11307972|NCT03128307|EG000|Reported Event|Clinical Trial Participants|Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
11307973|NCT03128372|BG000|Baseline|Desaturation|"Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.~Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%."
10848531|NCT00290329|OG001|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11307974|NCT03128372|FG000|Participant Flow|Desaturation|"Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.~Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%."
11307975|NCT03128372|OG000|Outcome|Desaturation|"Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.~Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%."
11307976|NCT03128372|EG000|Reported Event|Desaturation|"Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.~Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%."
11307977|NCT03128723|BG000|Baseline|Acne Mask|The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
11307978|NCT03128723|FG000|Participant Flow|Acne Mask|The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
11307979|NCT03128723|OG000|Outcome|Acne Mask|The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
11307980|NCT03128723|EG000|Reported Event|Acne Mask|The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
11307981|NCT03128892|BG000|Baseline|Oxygen Reserve Index (ORi) - RD Lite Sensors|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
11307982|NCT03128892|FG000|Participant Flow|Oxygen Reserve Index (ORi) - RD Lite Sensors|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
11307983|NCT03128892|OG000|Outcome|Oxygen Reserve Index (ORi) - RD Lite Sensors|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
11307984|NCT03128892|EG000|Reported Event|Oxygen Reserve Index (ORi) - RD Lite Sensors|All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
11307985|NCT03129178|BG000|Baseline|Beetroot Juice, Then, Nitrate Depleted Beetroot Juice|"Participants consumed 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Following a 7 day washout, then swapped into the nitrate depleted beetroot juice arm."
11307986|NCT03129178|BG001|Baseline|Nitrate Depleted Beetroot Juice, Then, Beetroot Juice|"Participants consumed 140ml of nitrate depleted beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Following a 7 day washout, then swapped into the beetroot juice arm."
11307987|NCT03129178|BG002|Baseline|Total|Total of all reporting groups
11307988|NCT03129178|FG000|Participant Flow|Beetroot Juice, Then Nitrate Depleted Beetroot Juice|"Participants consumed 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Following a 7 day washout, then swapped into the nitrate depleted beetroot juice arm."
11307989|NCT03129178|FG001|Participant Flow|Nitrate Depleted Beetroot Juice, Then Beetroot Juice|"Participants consumed 140ml of nitrate depleted beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Following a 7 day washout, then swapped into the beetroot juice arm."
11307990|NCT03129178|OG000|Outcome|Concentrated Beetroot Juice|"Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice."
11307991|NCT03129178|OG001|Outcome|Nitrate Depleted Beetroot Juice|"Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice."
11307992|NCT03129178|OG000|Outcome|Overall Number of Participants Analyzed|This Overall Number of Participants Analyzed reflects the total number of individuals approached for recruitment for this study
11307993|NCT03129178|EG000|Reported Event|Concentrated Beetroot Juice|"Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.~Total time on this arm is 14 days."
11307994|NCT03129178|EG001|Reported Event|Nitrate Depleted Beetroot Juice|"Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.~Concentrated beetroot juice: Acute and chronic supplementation of beetroot juice.~Total time on this arm is 14 days."
11307995|NCT03129568|BG000|Baseline|CDC Infusion|"CDCs infusion by coronary intervention.~CDC infusion: Injection of CDCs (0.3 million per kg of body weight)."
11307996|NCT03129568|FG000|Participant Flow|CDC Infusion|"CDCs infusion by coronary intervention.~CDC infusion: Injection of CDCs (0.3 million per kg of body weight)."
11307997|NCT03129568|OG000|Outcome|CDC Infusion|"CDCs infusion by coronary intervention.~CDC infusion: Injection of CDCs (0.3 million per kg of body weight)."
11307998|NCT03129568|EG000|Reported Event|CDC Infusion|"CDCs infusion by coronary intervention.~CDC infusion: Injection of CDCs (0.3 million per kg of body weight)."
11307999|NCT03129945|BG000|Baseline|Nifedipine|"Participants will be given this medication orally~Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours."
11308000|NCT03129945|BG001|Baseline|Indomethacin|"Participants will be given this medication orally~Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment."
11308001|NCT03129945|BG002|Baseline|Total|Total of all reporting groups
11308002|NCT03129945|FG000|Participant Flow|Nifedipine|"Participants will be given this medication orally~Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours."
11308003|NCT03129945|FG001|Participant Flow|Indomethacin|"Participants will be given this medication orally~Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment."
11308004|NCT03129945|OG000|Outcome|Nifedipine|"Participants will be given this medication orally~Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours."
11308005|NCT03129945|OG001|Outcome|Indomethacin|"Participants will be given this medication orally~Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment."
11308006|NCT03129945|EG000|Reported Event|Nifedipine|"Participants will be given this medication orally~Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours."
11308007|NCT03129945|EG001|Reported Event|Indomethacin|"Participants will be given this medication orally~Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment."
11308008|NCT03130257|BG000|Baseline|Clinic Blood Pressure Measurement|"Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308009|NCT03130257|BG001|Baseline|Home Blood Pressure Measurement|"Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308010|NCT03130257|BG002|Baseline|Kiosk Blood Pressure Measurement|"Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308011|NCT03130257|BG003|Baseline|Total|Total of all reporting groups
11308012|NCT03130257|FG000|Participant Flow|Clinic Blood Pressure Measurement|"Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308013|NCT03130257|FG001|Participant Flow|Home Blood Pressure Measurement|"Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308014|NCT03130257|FG002|Participant Flow|Kiosk Blood Pressure Measurement|"Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308015|NCT03130257|OG000|Outcome|Clinic Blood Pressure Measurement|"Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308016|NCT03130257|OG001|Outcome|Home Blood Pressure Measurement|"Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308017|NCT03130257|OG002|Outcome|Kiosk Blood Pressure Measurement|"Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
10848532|NCT00290329|OG002|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11308018|NCT03130257|EG000|Reported Event|Clinic Blood Pressure Measurement|"Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308019|NCT03130257|EG001|Reported Event|Home Blood Pressure Measurement|"Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over 3 weeks.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308020|NCT03130257|EG002|Reported Event|Kiosk Blood Pressure Measurement|"Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy.~Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period"
11308021|NCT03130738|BG000|Baseline|7-Day Miconazole Oil (Miconazole 2%)|"7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308022|NCT03130738|BG001|Baseline|14-Day Miconazole Oil (Miconazole 2%)|"14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308023|NCT03130738|BG002|Baseline|14-Day Placebo - Oil Vehicle|"14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient~14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient"
11308024|NCT03130738|BG003|Baseline|Total|Total of all reporting groups
11308025|NCT03130738|FG000|Participant Flow|7-Day Miconazole Oil (Miconazole 2%)|"7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308026|NCT03130738|FG001|Participant Flow|14-Day Miconazole Oil (Miconazole 2%)|"14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308027|NCT03130738|FG002|Participant Flow|14-Day Placebo - Oil Vehicle|"14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient~14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient"
11308028|NCT03130738|OG000|Outcome|7-Day Miconazole Oil (Miconazole 2%)|"7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308029|NCT03130738|OG001|Outcome|14-Day Miconazole Oil (Miconazole 2%)|"14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308030|NCT03130738|OG002|Outcome|14-Day Placebo - Oil Vehicle|"14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient~14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient"
11308031|NCT03130738|EG000|Reported Event|7-Day Miconazole Oil (Miconazole 2%)|"7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308032|NCT03130738|EG001|Reported Event|14-Day Miconazole Oil (Miconazole 2%)|"14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)~14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)"
11308033|NCT03130738|EG002|Reported Event|14-Day Placebo - Oil Vehicle|"14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient~14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient"
11308034|NCT03131167|BG000|Baseline|Placebo QD|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308035|NCT03131167|BG001|Baseline|SHP639 0.1% QD|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308036|NCT03131167|BG002|Baseline|SHP639 0.3% QD|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308037|NCT03131167|BG003|Baseline|SHP639 0.6% QD|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308038|NCT03131167|BG004|Baseline|Placebo BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308039|NCT03131167|BG005|Baseline|SHP639 0.1% BID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308040|NCT03131167|BG006|Baseline|SHP639 0.3% BID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308041|NCT03131167|BG007|Baseline|SHP639 0.6% BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308042|NCT03131167|BG008|Baseline|Placebo Repeated BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308043|NCT03131167|BG009|Baseline|SHP639 0.6% Repeated BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308044|NCT03131167|BG010|Baseline|Placebo TID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308045|NCT03131167|BG011|Baseline|SHP639 0.1% TID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308046|NCT03131167|BG012|Baseline|SHP639 0.3% TID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308047|NCT03131167|BG013|Baseline|Total|Total of all reporting groups
11308048|NCT03131167|FG000|Participant Flow|Placebo QD|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308049|NCT03131167|FG001|Participant Flow|SHP639 0.1% QD|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308050|NCT03131167|FG002|Participant Flow|SHP639 0.3% QD|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308051|NCT03131167|FG003|Participant Flow|SHP639 0.6% QD|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308052|NCT03131167|FG004|Participant Flow|Placebo BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308053|NCT03131167|FG005|Participant Flow|SHP639 0.1% BID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308054|NCT03131167|FG006|Participant Flow|SHP639 0.3% BID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308055|NCT03131167|FG007|Participant Flow|SHP639 0.6% BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308056|NCT03131167|FG008|Participant Flow|Placebo Repeated BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308057|NCT03131167|FG009|Participant Flow|SHP639 0.6% Repeated BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308058|NCT03131167|FG010|Participant Flow|Placebo TID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308059|NCT03131167|FG011|Participant Flow|SHP639 0.1% TID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308060|NCT03131167|FG012|Participant Flow|SHP639 0.3% TID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308061|NCT03131167|OG000|Outcome|Placebo QD|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308062|NCT03131167|OG001|Outcome|SHP639 0.1% QD|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308063|NCT03131167|OG002|Outcome|SHP639 0.3% QD|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308064|NCT03131167|OG003|Outcome|SHP639 0.6% QD|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308065|NCT03131167|OG004|Outcome|Placebo BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308066|NCT03131167|OG005|Outcome|SHP639 0.1% BID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308067|NCT03131167|OG006|Outcome|SHP639 0.3% BID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen..
11308068|NCT03131167|OG007|Outcome|SHP639 0.6% BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308069|NCT03131167|OG008|Outcome|Placebo Repeated BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308070|NCT03131167|OG009|Outcome|SHP639 0.6% Repeated BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308071|NCT03131167|OG010|Outcome|Placebo TID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308072|NCT03131167|OG011|Outcome|SHP639 0.1% TID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308073|NCT03131167|OG012|Outcome|SHP639 0.3% TID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308074|NCT03131167|OG006|Outcome|SHP639 0.3% BID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308075|NCT03131167|EG000|Reported Event|Placebo QD|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308076|NCT03131167|EG001|Reported Event|SHP639 0.1% QD|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308077|NCT03131167|EG002|Reported Event|SHP639 0.3% QD|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308078|NCT03131167|EG003|Reported Event|SHP639 0.6% QD|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
11308079|NCT03131167|EG004|Reported Event|Placebo BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308080|NCT03131167|EG005|Reported Event|SHP639 0.1% BID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308081|NCT03131167|EG006|Reported Event|SHP639 0.3% BID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308082|NCT03131167|EG007|Reported Event|SHP639 0.6% BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
11308083|NCT03131167|EG008|Reported Event|Placebo Repeated BID|Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308084|NCT03131167|EG009|Reported Event|SHP639 0.6% Repeated BID|Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
11308085|NCT03131167|EG010|Reported Event|Placebo TID|Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308086|NCT03131167|EG011|Reported Event|SHP639 0.1% TID|Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308087|NCT03131167|EG012|Reported Event|SHP639 0.3% TID|Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
11308088|NCT03131206|BG000|Baseline|Phase 1 RP2D of Alectinib|Dose Level 1 (starting dose)
11308089|NCT03131206|BG001|Baseline|Phase 2 Cohort A|Participants with RET-positive NSCLC with no previous history of RET-TKI therapy.
11308090|NCT03131206|BG002|Baseline|Phase 2 Cohort B|Participants with RET-positive NSCLC with previous history of RET-TKI therapy.
11308091|NCT03131206|BG003|Baseline|Phase 2 Cohort C|Participants with RET-positive thyroid cancer
11308092|NCT03131206|BG004|Baseline|Total|Total of all reporting groups
10848533|NCT00290329|OG000|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
10972048|NCT00919061|EG000|Reported Event|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
11308093|NCT03131206|FG000|Participant Flow|Phase 1 RP2D of Alectinib|Alectinib will be administered orally twice daily. A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
11308094|NCT03131206|FG001|Participant Flow|Phase 2 Cohort A|Participants with RET-positive NSCLC with no previous history of RET-TKI therapy.
11308095|NCT03131206|FG002|Participant Flow|Phase 2 Cohort B|Participants with RET-positive NSCLC with previous history of RET-TKI therapy.
11308096|NCT03131206|FG003|Participant Flow|Phase 2 Cohort C|Participants with RET-positive thyroid cancer
11308097|NCT03131206|OG000|Outcome|Phase 1 RP2D of Alectinib|"The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated.~Alectinib~Oral, BID~A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~Alectinib: -- Oral, BID~Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days."
11308098|NCT03131206|OG001|Outcome|Cohort A|"Participants with RET-rearranged NSCLC with no previous history of RET-TKI therapy.~Alectinib~Oral, BID, participants will receive the RP2D identified during Phase 1.~Each treatment cycle will be defined as 28 consecutive days.~Alectinib: -- Oral, BID~Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days."
11308099|NCT03131206|OG002|Outcome|Cohort B|"Participants with RET-rearranged NSCLC with previous history of RET-TKI therapy.~Alectinib~Oral, BID, participants will receive the RP2D identified during Phase 1.~Each treatment cycle will be defined as 28 consecutive days.~Alectinib: -- Oral, BID~Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days."
11308100|NCT03131206|OG003|Outcome|Cohort C|"Participants with RET-rearranged thyroid cancer~Alectinib~Oral, BID, participants will receive the RP2D identified during Phase 1.~Each treatment cycle will be defined as 28 consecutive days.~Alectinib: -- Oral, BID~Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days."
11308101|NCT03131206|OG000|Outcome|Phase 1 RP2D of Alectinib|Alectinib will be administered orally twice daily. A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
11308102|NCT03131206|OG001|Outcome|Phase 2 Cohort A|Participants with RET-positive NSCLC with no previous history of RET-TKI therapy.
11308103|NCT03131206|OG002|Outcome|Phase 2 Cohort B|Participants with RET-positive NSCLC with previous history of RET-TKI therapy.
11308104|NCT03131206|OG003|Outcome|Phase 2 Cohort C|Participants with RET-positive thyroid cancer
11308105|NCT03131206|EG000|Reported Event|Phase 1 RP2D of Alectinib|"The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated. A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.~The AE data presented here includes all 5 participants which were enrolled to the Phase 1 portion of the study, to Dose Level 1."
11308106|NCT03131206|EG001|Reported Event|Phase 2 Cohort A|Participants with RET-positive NSCLC with no previous history of RET-TKI therapy. No participants were enrolled to Cohort A.
11308107|NCT03131206|EG002|Reported Event|Phase 2 Cohort B|Participants with RET-positive NSCLC with previous history of RET-TKI therapy. No participants were enrolled to Cohort B.
11308108|NCT03131206|EG003|Reported Event|Phase 2 Cohort C|Participants with RET-positive thyroid cancer. No participants were enrolled to Cohort C.
11308109|NCT03131453|BG000|Baseline|CNP520 50 mg|50 mg capsule taken orally once daily
11308110|NCT03131453|BG001|Baseline|CNP520 15 mg|15 mg capsule taken orally once daily
11308111|NCT03131453|BG002|Baseline|Placebo|Matching placebo to 15 and 50 mg CNP520 taken orally once daily
11308112|NCT03131453|BG003|Baseline|Total|Total of all reporting groups
11308113|NCT03131453|FG000|Participant Flow|CNP520 50 mg|50 mg capsule taken orally once daily
11308114|NCT03131453|FG001|Participant Flow|CNP520 15 mg|15 mg capsule taken orally once daily
11308115|NCT03131453|FG002|Participant Flow|Placebo|Matching placebo to 15 and 50 mg CNP520 taken orally once daily
11308116|NCT03131453|OG000|Outcome|CNP520 50 mg|50 mg capsule taken orally once daily
11308117|NCT03131453|OG001|Outcome|CNP520 15 mg|15 mg capsule taken orally once daily
11308118|NCT03131453|OG002|Outcome|Placebo|Matching placebo to 15 and 50 mg CNP520 taken orally once daily
11308119|NCT03131453|EG000|Reported Event|CNP520 50 mg|50 mg capsule taken orally once daily
10848534|NCT00290329|OG001|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11308120|NCT03131453|EG001|Reported Event|CNP520 15 mg|15 mg capsule taken orally once daily
11308121|NCT03131453|EG002|Reported Event|Placebo|Matching placebo to 15 and 50 mg CNP520 taken orally once daily
11308122|NCT03131479|BG000|Baseline|Mild|Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
11308123|NCT03131479|BG001|Baseline|Moderate A|Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
11308124|NCT03131479|BG002|Baseline|Moderate B|Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
11308125|NCT03131479|BG003|Baseline|Severe|Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
11308126|NCT03131479|BG004|Baseline|Normal|Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
11308127|NCT03131479|BG005|Baseline|Total|Total of all reporting groups
11308128|NCT03131479|FG000|Participant Flow|Mild|Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
11308129|NCT03131479|FG001|Participant Flow|Moderate A|Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
10972049|NCT00919100|BG000|Baseline|Standard Care|"venipuncture with vapocoolant spray offered~vapocoolant: venipuncture with vapocoolant spray offered"
11308130|NCT03131479|FG002|Participant Flow|Moderate B|Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
11308131|NCT03131479|FG003|Participant Flow|Severe|Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
11308132|NCT03131479|FG004|Participant Flow|Normal|Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
11308133|NCT03131479|OG000|Outcome|Normal|Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
11308134|NCT03131479|OG001|Outcome|Mild|Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
11308135|NCT03131479|OG002|Outcome|Moderate A|Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
11308136|NCT03131479|OG003|Outcome|Moderate B|Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
11308137|NCT03131479|OG004|Outcome|Severe|Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
11308138|NCT03131479|EG000|Reported Event|Normal|Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
11308139|NCT03131479|EG001|Reported Event|Mild|Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
11308140|NCT03131479|EG002|Reported Event|Moderate A|Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
11308141|NCT03131479|EG003|Reported Event|Moderate B|Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
11308142|NCT03131479|EG004|Reported Event|Severe|Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
11308143|NCT03131570|BG000|Baseline|Group 1|"6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.~Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308144|NCT03131570|BG001|Baseline|Group 2|"Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.~Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308145|NCT03131570|BG002|Baseline|Total|Total of all reporting groups
11308146|NCT03131570|FG000|Participant Flow|Secukinumab Only|"6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.~Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308147|NCT03131570|FG001|Participant Flow|Placebo Then Secukinumab|"Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.~Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308148|NCT03131570|OG000|Outcome|Group 1|"6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.~Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308149|NCT03131570|OG001|Outcome|Group 2|"Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.~Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308150|NCT03131570|EG000|Reported Event|Group 1|"6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.~Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308151|NCT03131570|EG001|Reported Event|Group 2|"Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.~Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks)."
11308152|NCT03131596|BG000|Baseline|IUB Dilatation Therapy|"The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will carried out 8 weeks after the surgery.~IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present."
11308153|NCT03131596|BG001|Baseline|Control Group|Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
11308154|NCT03131596|BG002|Baseline|Total|Total of all reporting groups
11308155|NCT03131596|FG000|Participant Flow|IUB Dilatation Therapy|"The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will carried out 8 weeks after the surgery.~IUB dilatation therapy: A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present."
11308156|NCT03131596|FG001|Participant Flow|Control Group|Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
11308157|NCT03131596|OG000|Outcome|IUB Dilatation Therapy|"The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will carried out 8 weeks after the surgery.~IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present."
11308158|NCT03131596|OG001|Outcome|Control Group|Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
11308159|NCT03131596|EG000|Reported Event|IUB Dilatation Therapy|"The patient will have Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.~IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present."
11308160|NCT03131596|EG001|Reported Event|Control Group|Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
11308161|NCT03131648|BG000|Baseline|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11308162|NCT03131648|BG001|Baseline|Initial Treatment Period - Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo."
11308163|NCT03131648|BG002|Baseline|Total|Total of all reporting groups
11308164|NCT03131648|FG000|Participant Flow|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11308165|NCT03131648|FG001|Participant Flow|Initial Treatment Period - Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo."
11308166|NCT03131648|FG002|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen.~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab."
11308167|NCT03131648|FG003|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen.~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11308168|NCT03131648|FG004|Participant Flow|Maintenance Treatment Period - Placebo Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to placebo Q2W dosing regimen.~At each visit, each subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11308169|NCT03131648|FG005|Participant Flow|Maintenance Treatment Period- Placebo Q2W - Tralokinumab Naive|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11308170|NCT03131648|FG006|Participant Flow|Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS|"Week 16 to Week 52:~Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if~IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR~IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR~Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA>1 at Week 16~At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg."
11308171|NCT03131648|FG007|Participant Flow|Open-label Treatment - Tralokinumab 300 mg Q2W + Optional TCS|"Week 52 to Week 66 [Short term extension (Japan only)]:~Japanese subjects who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) continued an additional 16 weeks (Week 52 to Week 66) of open-label treatment to receive 52 weeks of active therapy.~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg."
11308172|NCT03131648|OG000|Outcome|Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11308173|NCT03131648|OG001|Outcome|Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo."
11308174|NCT03131648|OG000|Outcome|Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen.~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab."
11308175|NCT03131648|OG001|Outcome|Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen.~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11308176|NCT03131648|OG002|Outcome|Placebo Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11308177|NCT03131648|OG001|Outcome|Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen.~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11308178|NCT03131648|OG001|Outcome|Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W.~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo."
11308179|NCT03131648|EG000|Reported Event|Initial Period - Tralokinumab Q2W|"Initial Period - Tralokinumab Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11308180|NCT03131648|EG001|Reported Event|Initial Period - Placebo|"Initial Period - Placebo~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo."
11308181|NCT03131648|EG002|Reported Event|Maintenance Period - Tralokinumab Q2W|"Maintenance Period - Tralokinumab Q2W~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen.~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab."
11308182|NCT03131648|EG003|Reported Event|Maintenance Period - Tralokinumab Q4W|"Maintenance Period - Tralokinumab Q4W~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen.~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11308183|NCT03131648|EG004|Reported Event|Maintenance Period - Placebo|"Maintenance Period - Placebo~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11308184|NCT03131648|EG005|Reported Event|Maintenance Period - Placebo - Tralokinumab Naive|"Maintenance Period - Placebo - Tralokinumab Naive~Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11333086|NCT03508661|FG000|Participant Flow|SPIN-SSLED Program|SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 &7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
11308185|NCT03131648|EG006|Reported Event|Open-label Period - Tralokinumab Q2W + Optional TCS|"Open-label Period - Tralokinumab Q2W + Optional TCS~Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA>1 at Week 16 At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg."
11308186|NCT03131648|EG007|Reported Event|Safety Follow-up|Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during the safety follow-up period. Eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
11308187|NCT03131687|BG000|Baseline|Placebo|Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
11308188|NCT03131687|BG001|Baseline|1 mg Tirzepatide|1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308189|NCT03131687|BG002|Baseline|5 mg Tirzepatide|5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308190|NCT03131687|BG003|Baseline|10 mg Tirzepatide|10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308191|NCT03131687|BG004|Baseline|15 mg Tirzepatide|15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308192|NCT03131687|BG005|Baseline|1.5 mg Dulaglutide|1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
11308193|NCT03131687|BG006|Baseline|Total|Total of all reporting groups
11308194|NCT03131687|FG000|Participant Flow|Placebo|Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
11308195|NCT03131687|FG001|Participant Flow|1 mg Tirzepatide|1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308196|NCT03131687|FG002|Participant Flow|5 mg Tirzepatide|5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308197|NCT03131687|FG003|Participant Flow|10 mg Tirzepatide|10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308198|NCT03131687|FG004|Participant Flow|15 mg Tirzepatide|15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308199|NCT03131687|FG005|Participant Flow|1.5 mg Dulaglutide|1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
11308200|NCT03131687|OG000|Outcome|Placebo|Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
11308201|NCT03131687|OG001|Outcome|1 mg Tirzepatide|1 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308202|NCT03131687|OG002|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308203|NCT03131687|OG003|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308204|NCT03131687|OG004|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308205|NCT03131687|OG005|Outcome|1.5 mg Dulaglutide|1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
11308206|NCT03131687|OG001|Outcome|1 mg Tirzepatide|1 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
11308207|NCT03131687|OG002|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308208|NCT03131687|OG002|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered SC. Dulaglutide placebo administered SC once weekly.
11308209|NCT03131687|OG005|Outcome|1.5 mg Dulaglutide|1.5 mg Dulaglutide administered SC. Tirzepatide placebo administered SC.
11308210|NCT03131687|OG000|Outcome|Placebo|Tirzepatide placebo and dulaglutide placebo administered SC once weekly.
11308211|NCT03131687|OG000|Outcome|Placebo|Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC).
11308212|NCT03131687|OG001|Outcome|1 mg Tirzepatide|1 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308213|NCT03131687|OG003|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308214|NCT03131687|OG004|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308215|NCT03131687|OG000|Outcome|1 mg Tirzepatide|1 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308216|NCT03131687|OG001|Outcome|5 mg Tirzepatide|5 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308217|NCT03131687|OG002|Outcome|10 mg Tirzepatide|10 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308218|NCT03131687|OG003|Outcome|15 mg Tirzepatide|15 mg tirzepatide administered SC. Dulaglutide placebo administered SC.
11308219|NCT03131687|EG000|Reported Event|Placebo|Tirzepatide placebo and dulaglutide placebo administered (SC) once weekly.
11308220|NCT03131687|EG001|Reported Event|1 mg Tirzepatide|1 mg tirzepatide and placebo given SC once weekly.
11308221|NCT03131687|EG002|Reported Event|5 mg Tirzepatide|5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308222|NCT03131687|EG003|Reported Event|10 mg Tirzepatide|10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308223|NCT03131687|EG004|Reported Event|15 mg Tirzepatide + Placebo|15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
11308224|NCT03131687|EG005|Reported Event|1.5 mg Dulaglutide|1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
11308225|NCT03131713|BG000|Baseline|Control|The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
11308226|NCT03131713|BG001|Baseline|Intervention|"The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.~Acetaminophen: Acetaminophen 1000mg"
11308227|NCT03131713|BG002|Baseline|Total|Total of all reporting groups
11308228|NCT03131713|FG000|Participant Flow|Control|The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
11308229|NCT03131713|FG001|Participant Flow|Intervention|"The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.~Acetaminophen: Acetaminophen 1000mg"
11308230|NCT03131713|OG000|Outcome|Control|The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
11308231|NCT03131713|OG001|Outcome|Intervention|"The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.~Acetaminophen: Acetaminophen 1000mg"
11308232|NCT03131713|EG000|Reported Event|Control|"The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.~Acetaminophen: Acetaminophen 1000mg"
11308233|NCT03131713|EG001|Reported Event|Intervention|"The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.~Acetaminophen: Acetaminophen 1000mg"
11308234|NCT03131895|BG000|Baseline|Part 1: Dexlansoprazole 30 mg TOB+ Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308235|NCT03131895|BG001|Baseline|Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308236|NCT03131895|BG002|Baseline|Part 2: Dexlansoprazole 60 mg TOB+ Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308237|NCT03131895|BG003|Baseline|Part 2: Dexlansoprazole 60 mg TPC+ Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308238|NCT03131895|BG004|Baseline|Total|Total of all reporting groups
11308239|NCT03131895|FG000|Participant Flow|Part 1: Dexlansoprazole 30 mg TOB+ Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308240|NCT03131895|FG001|Participant Flow|Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308241|NCT03131895|FG002|Participant Flow|Part 2: Dexlansoprazole 60 mg TOB+ Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308242|NCT03131895|FG003|Participant Flow|Part 2: Dexlansoprazole 60 mg TPC+ Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 following a 10-hour fast, followed by minimum of 5-day washout period, further followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test) orally, once on Day 1 of Intervention Period 1 following a 10-hour fast.
11308243|NCT03131895|OG000|Outcome|Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2.
11308244|NCT03131895|OG001|Outcome|Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2.
11308245|NCT03131895|OG002|Outcome|Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2.
11308246|NCT03131895|OG003|Outcome|Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2.
11308247|NCT03131895|EG000|Reported Event|Dexlansoprazole 30 mg TOB|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2.
11308248|NCT03131895|EG001|Reported Event|Dexlansoprazole 30 mg TPC|Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2.
11308249|NCT03131895|EG002|Reported Event|Dexlansoprazole 60 mg TOB|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (test), orally, once on Day 1 of Intervention Period 1 or 2.
10848535|NCT00290329|EG000|Reported Event|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
10972050|NCT00919100|BG001|Baseline|Buzzy|"Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.~Buzzy: Buzzy is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front."
10972051|NCT00919100|BG002|Baseline|Total|Total of all reporting groups
10972052|NCT00919100|FG000|Participant Flow|Standard Care|"venipuncture with vapocoolant spray offered~vapocoolant: venipuncture with vapocoolant spray offered"
11308250|NCT03131895|EG003|Reported Event|Dexlansoprazole 60 mg TPC|Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (reference), orally, once on Day 1 of Intervention Period 1 or 2.
11308251|NCT03131999|BG000|Baseline|Imatinib Mesylate 400mg Capsule|"56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.~Imatinib Mesylate 400Mg Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308252|NCT03131999|BG001|Baseline|Placebo Capsule|"56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.~Placebo - Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308253|NCT03131999|BG002|Baseline|Total|Total of all reporting groups
11308254|NCT03131999|FG000|Participant Flow|Imatinib Mesylate 400mg Capsule|"56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.~Imatinib Mesylate 400Mg Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308255|NCT03131999|FG001|Participant Flow|Placebo Capsule|"56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.~Placebo - Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308256|NCT03131999|OG000|Outcome|Imatinib Mesylate 400mg Capsule|"56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.~Imatinib Mesylate 400Mg Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308257|NCT03131999|OG001|Outcome|Placebo Capsule|"56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.~Placebo - Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308258|NCT03131999|EG000|Reported Event|Imatinib Mesylate 400mg Capsule|"56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.~Imatinib Mesylate 400Mg Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308259|NCT03131999|EG001|Reported Event|Placebo Capsule|"56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.~Placebo - Capsule: Sirolimus or everolimus will be withdrawn after 28 days if used at baseline"
11308260|NCT03132220|BG000|Baseline|Book Club Active Control|"The subject will participate in 16 hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a fun activity to do outside of work to help reduce work-related stress. The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress.~Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention."
11308261|NCT03132220|BG001|Baseline|MBCT Intervention|"The subject will participate in 16 hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity.~Mindfulness-Based Cognitive Therapy: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores."
11308262|NCT03132220|BG002|Baseline|Total|Total of all reporting groups
11308263|NCT03132220|FG000|Participant Flow|MBCT Intervention|"The subject will participate in 16 hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity.~Mindfulness-Based Cognitive Therapy: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of post-traumatic stress disorder (PTSD) and burnout syndrome (BOS) and increase resiliency scores."
11308264|NCT03132220|FG001|Participant Flow|Book Club Active Control|"The subject will participate in 16 hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a fun activity to do outside of work to help reduce work-related stress. The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress.~Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention."
11308265|NCT03132220|OG000|Outcome|Book Club Active Control|"The subject will participate in 16 hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a fun activity to do outside of work to help reduce work-related stress. The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress.~Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention."
11308266|NCT03132220|OG001|Outcome|MBCT Intervention|"The subject will participate in 16 hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity.~Mindfulness-Based Cognitive Therapy: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores."
11308267|NCT03132220|EG000|Reported Event|Book Club Active Control|"The subject will participate in 16 hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a fun activity to do outside of work to help reduce work-related stress. The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress.~Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention."
11308268|NCT03132220|EG001|Reported Event|MBCT Intervention|"The subject will participate in 16 hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity.~Mindfulness-Based Cognitive Therapy: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores."
11308269|NCT03132246|BG000|Baseline|Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. All patients in this arm went on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory."
11308270|NCT03132246|BG001|Baseline|Not Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. All patients in this arm did not go on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory."
11308271|NCT03132246|BG002|Baseline|Total|Total of all reporting groups
11308272|NCT03132246|FG000|Participant Flow|Enrolled|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.~Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. Group assignment is unknown for patients that did not complete the study and therefore groups are combined for reporting overall study numbers."
11308273|NCT03132246|OG000|Outcome|Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. All patients in this arm went on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory."
11308274|NCT03132246|OG001|Outcome|Not Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. All patients in this arm did not go on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory."
11308275|NCT03132246|EG000|Reported Event|Unmasked Non-completers|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.~Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. Group assignment is unknown for patients that did not complete the study and therefore this group is representative of those patients that were enrolled but did not complete the study."
11308276|NCT03132246|EG001|Reported Event|Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.~Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group went on to develop an infection."
11308277|NCT03132246|EG002|Reported Event|Not Infected|"Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.~The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.~Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group did not go on to develop an infection."
11308278|NCT03132298|BG000|Baseline|Implicit Theories of Personality Program|"This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people's traits are malleable, given the brain's capacity for change; 3. Further vignettes by older youths describing times when they used growth mindsets to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants' lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks."
11308279|NCT03132298|BG001|Baseline|Control Program|The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
11308280|NCT03132298|BG002|Baseline|Total|Total of all reporting groups
11308281|NCT03132298|FG000|Participant Flow|Implicit Theories of Personality Program|"This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people's traits are malleable, given the brain's capacity for change; 3. Further vignettes by older youths describing times when they used growth mindsets to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants' lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks."
11308282|NCT03132298|FG001|Participant Flow|Control Program|The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
11308283|NCT03132298|OG000|Outcome|Implicit Theories of Personality Program|"This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people's traits are malleable, given the brain's capacity for change; 3. Further vignettes by older youths describing times when they used growth mindsets to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants' lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks."
11308284|NCT03132298|OG001|Outcome|Control Program|The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
11308285|NCT03132298|EG000|Reported Event|Implicit Theories of Personality Program|"This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people's traits are malleable, given the brain's capacity for change; 3. Further vignettes by older youths describing times when they used growth mindsets to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants' lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks."
11308286|NCT03132298|EG001|Reported Event|Control Program|The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
10972053|NCT00919100|FG001|Participant Flow|Buzzy|"Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.~Buzzy: Buzzy is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front."
10972054|NCT00919100|OG000|Outcome|Standard Care|"venipuncture with vapocoolant spray offered~vapocoolant: venipuncture with vapocoolant spray offered"
10972055|NCT00919100|OG001|Outcome|Buzzy|"Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.~Buzzy: Buzzy is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front."
10972056|NCT00919100|EG000|Reported Event|Standard Care|"venipuncture with vapocoolant spray offered~vapocoolant: venipuncture with vapocoolant spray offered"
10972057|NCT00919100|EG001|Reported Event|Buzzy|"Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.~Buzzy: Buzzy is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front."
10972058|NCT00919113|BG000|Baseline|Uracyst|2% sodium chondroitin sulfate
11308287|NCT03132571|BG000|Baseline|Naltrexone With Bupropion|"Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.~Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target."
11308288|NCT03132571|BG001|Baseline|Placebo With Bupropion|"Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.~Placebo: Oral placebo taken once daily for the course of the study (16 week)"
11308289|NCT03132571|BG002|Baseline|Total|Total of all reporting groups
11308290|NCT03132571|FG000|Participant Flow|Naltrexone With Bupropion|"Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.~Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target."
11308291|NCT03132571|FG001|Participant Flow|Placebo With Bupropion|"Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.~Placebo: Oral placebo taken once daily for the course of the study (16 week)"
11308292|NCT03132571|OG000|Outcome|Naltrexone With Bupropion|"Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.~Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target."
11308293|NCT03132571|OG001|Outcome|Placebo With Bupropion|"Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.~Placebo: Oral placebo taken once daily for the course of the study (16 week)"
11308294|NCT03132571|EG000|Reported Event|Naltrexone With Bupropion|"Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.~Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target."
11308295|NCT03132571|EG001|Reported Event|Placebo With Bupropion|"Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.~Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.~Placebo: Oral placebo taken once daily for the course of the study (16 week)"
11308296|NCT03133481|BG000|Baseline|Adductor Canal Nerve Block|"Participants will be randomized using block randomization.~Adductor Canal Nerve Block: Adductor Canal never technique"
10972059|NCT00919113|BG001|Baseline|Placebo|identical buffer
10972060|NCT00919113|BG002|Baseline|Total|Total of all reporting groups
11308297|NCT03133481|BG001|Baseline|Femoral Nerve Block|"Participants will be randomized using block randomization.~Femoral Nerve Block: Traditional technique"
11308298|NCT03133481|BG002|Baseline|Total|Total of all reporting groups
10972061|NCT00919113|FG000|Participant Flow|Uracyst|2% sodium chondroitin sulfate
10972062|NCT00919113|FG001|Participant Flow|Placebo|identical buffer
10972063|NCT00919113|OG000|Outcome|Uracyst|2% sodium chondroitin sulfate
10972064|NCT00919113|OG001|Outcome|Placebo|identical buffer
10972065|NCT00919113|EG000|Reported Event|Uracyst|"2% sodium chondroitin sulfate~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
10972066|NCT00919113|EG001|Reported Event|Placebo|"identical buffer~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
11308299|NCT03133481|FG000|Participant Flow|Adductor Canal Nerve Block|"Participants will be randomized using block randomization.~Adductor Canal Nerve Block: Adductor Canal never technique"
11308300|NCT03133481|FG001|Participant Flow|Femoral Nerve Block|"Participants will be randomized using block randomization.~Femoral Nerve Block: Traditional technique"
11308301|NCT03133481|OG000|Outcome|Adductor Canal Nerve Block|"Participants will be randomized using block randomization.~Adductor Canal Nerve Block: Adductor Canal never technique"
11308302|NCT03133481|OG001|Outcome|Femoral Nerve Block|"Participants will be randomized using block randomization.~Femoral Nerve Block: Traditional technique"
11308303|NCT03133481|EG000|Reported Event|Adductor Canal Nerve Block|"Participants will be randomized using block randomization.~Adductor Canal Nerve Block: Adductor Canal never technique"
11308304|NCT03133481|EG001|Reported Event|Femoral Nerve Block|"Participants will be randomized using block randomization.~Femoral Nerve Block: Traditional technique"
11308305|NCT03133676|BG000|Baseline|Placebo (SAD)|Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
11308306|NCT03133676|BG001|Baseline|Cohort 1: KA34 50 µg (SAD)|Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
11308307|NCT03133676|BG002|Baseline|Cohort 2: KA34 100 µg (SAD)|Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
11308308|NCT03133676|BG003|Baseline|Cohort 3: KA34 200 µg (SAD)|Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
11308309|NCT03133676|BG004|Baseline|Cohort 4: KA34 400 µg (SAD)|Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
11308310|NCT03133676|BG005|Baseline|Placebo (MAD)|Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
11308311|NCT03133676|BG006|Baseline|Cohort 5: KA34 100 µg (MAD)|Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308312|NCT03133676|BG007|Baseline|Cohort 6: KA34 200 µg (MAD)|Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308313|NCT03133676|BG008|Baseline|Cohort 7: KA34 400 µg (MAD)|Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308314|NCT03133676|BG009|Baseline|Total|Total of all reporting groups
11308315|NCT03133676|FG000|Participant Flow|Placebo (SAD)|Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single intra-articular (IA) injections of matching placebo in the affected knee and were followed up until Day 29.
11308316|NCT03133676|FG001|Participant Flow|Cohort 1: KA34 50 µg (SAD)|Subjects received a single IA injection of 50 micrograms (µg) KA34 in the affected knee and were followed up until Day 29.
11308317|NCT03133676|FG002|Participant Flow|Cohort 2: KA34 100 µg (SAD)|Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
11308318|NCT03133676|FG003|Participant Flow|Cohort 3: KA34 200 µg (SAD)|Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
11308319|NCT03133676|FG004|Participant Flow|Cohort 4: KA34 400 µg (SAD)|Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
11308320|NCT03133676|FG005|Participant Flow|Placebo (MAD)|Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
11308321|NCT03133676|FG006|Participant Flow|Cohort 5: KA34 100 µg (MAD)|Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308322|NCT03133676|FG007|Participant Flow|Cohort 6: KA34 200 µg (MAD)|Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308323|NCT03133676|FG008|Participant Flow|Cohort 7: KA34 400 µg (MAD)|Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308324|NCT03133676|OG000|Outcome|Placebo (SAD)|Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
11308325|NCT03133676|OG001|Outcome|Cohort 1: KA34 50 µg (SAD)|Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
11308326|NCT03133676|OG002|Outcome|Cohort 2: KA34 100 µg (SAD)|Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
10848536|NCT00290329|EG001|Reported Event|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11308327|NCT03133676|OG003|Outcome|Cohort 3: KA34 200 µg (SAD)|Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
11308328|NCT03133676|OG004|Outcome|Cohort 4: KA34 400 µg (SAD)|Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
11308329|NCT03133676|OG000|Outcome|Placebo (MAD)|Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
11308330|NCT03133676|OG001|Outcome|Cohort 5: KA34 100 µg (MAD)|Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308331|NCT03133676|OG002|Outcome|Cohort 6: KA34 200 µg (MAD)|Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308332|NCT03133676|OG003|Outcome|Cohort 7: KA34 400 µg (MAD)|Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308333|NCT03133676|OG000|Outcome|Cohort 1: KA34 50 µg (SAD)|Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
11308334|NCT03133676|OG001|Outcome|Cohort 2: KA34 100 µg (SAD)|Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
11308335|NCT03133676|OG002|Outcome|Cohort 3: KA34 200 µg (SAD)|Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
11308336|NCT03133676|OG003|Outcome|Cohort 4: KA34 400 µg (SAD)|Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
11308337|NCT03133676|OG000|Outcome|Cohort 5: KA34 100 µg (MAD)|Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308338|NCT03133676|OG001|Outcome|Cohort 6: KA34 200 µg (MAD)|Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308339|NCT03133676|OG002|Outcome|Cohort 7: KA34 400 µg (MAD)|Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308340|NCT03133676|EG000|Reported Event|Placebo (SAD)|Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
11308341|NCT03133676|EG001|Reported Event|Cohort 1: KA34 50 µg (SAD)|Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
11308342|NCT03133676|EG002|Reported Event|Cohort 2: KA34 100 µg (SAD)|Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
11308343|NCT03133676|EG003|Reported Event|Cohort 3: KA34 200 µg (SAD)|Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
11308344|NCT03133676|EG004|Reported Event|Cohort 4: KA34 400 µg (SAD)|Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
11308345|NCT03133676|EG005|Reported Event|Placebo (MAD)|Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
11308346|NCT03133676|EG006|Reported Event|Cohort 5: KA34 100 µg (MAD)|Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308347|NCT03133676|EG007|Reported Event|Cohort 6: KA34 200 µg (MAD)|Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308348|NCT03133676|EG008|Reported Event|Cohort 7: KA34 400 µg (MAD)|Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
11308349|NCT03133767|BG000|Baseline|Lactated Ringers Solution|"Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay~Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV"
11308350|NCT03133767|BG001|Baseline|Normal Saline Solution|"Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay~Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV"
11308351|NCT03133767|BG002|Baseline|Total|Total of all reporting groups
11308352|NCT03133767|FG000|Participant Flow|Lactated Ringers Solution|"Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay~Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV"
11308353|NCT03133767|FG001|Participant Flow|Normal Saline Solution|"Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay~Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV"
11308354|NCT03133767|OG000|Outcome|Lactated Ringers Solution|"Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay~Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV"
11308355|NCT03133767|OG001|Outcome|Normal Saline Solution|"Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay~Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV"
11308356|NCT03133767|EG000|Reported Event|Lactated Ringers Solution|"Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay~Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV"
11308357|NCT03133767|EG001|Reported Event|Normal Saline Solution|"Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay~Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV"
11308358|NCT03134092|BG000|Baseline|Generalized Risk Communication (GRC)|Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
11308359|NCT03134092|BG001|Baseline|Probabilistic Risk Communication (PRT)|"Probabilistic Risk Communication (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.~\"
11308360|NCT03134092|BG002|Baseline|Narrative Enhanced Risk Tool (NERT)|Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
11308361|NCT03134092|BG003|Baseline|Total|Total of all reporting groups
11308362|NCT03134092|FG000|Participant Flow|Generalized Risk Communication (GRC)|Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
11308363|NCT03134092|FG001|Participant Flow|Probabilistic Risk Communication (PRT)|Probabilistic Risk Communication Tool (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
11308364|NCT03134092|FG002|Participant Flow|Narrative Enhanced Risk Tool (NERT)|Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch two narrative videos. This video intervention will include a brief narrative video of an individuals' experience with pain and/or pain treatment with opioids. Narrative videos were developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
11308365|NCT03134092|OG000|Outcome|Probabilistic Risk Communication (PRT)|Probabilistic Risk Communication (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
11308366|NCT03134092|OG001|Outcome|Narrative Enhanced Risk Tool (NERT)|Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
11308367|NCT03134092|OG000|Outcome|Generalized Risk Communication (GRC)|Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
11308368|NCT03134092|OG001|Outcome|Probabilistic Risk Communication (PRT)|"Probabilistic Risk Communication (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.~Probabilistic Risk Communication Tool (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given"
11308369|NCT03134092|OG002|Outcome|Narrative Enhanced Risk Tool (NERT)|"Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.~Probabilistic Risk Communication Tool (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that infor"
11308370|NCT03134092|OG001|Outcome|Probabilistic Risk Communication (PRT)|Probabilistic Risk Communication Tool (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
11308371|NCT03134092|OG002|Outcome|Narrative Enhanced Risk Tool (NERT)|Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch two narrative videos. This video intervention will include a brief narrative video of an individuals' experience with pain and/or pain treatment with opioids. Narrative videos were developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
11308372|NCT03134092|EG000|Reported Event|Generalized Risk Communication (GRC)|Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
10972067|NCT00919126|BG000|Baseline|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
11308373|NCT03134092|EG001|Reported Event|Probabilistic Risk Communication (PRT)|Probabilistic Risk Communication (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
11308374|NCT03134092|EG002|Reported Event|Narrative Enhanced Risk Tool (NERT)|Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
11308375|NCT03134144|BG000|Baseline|First Without Exoskeleton Then With Exoskeleton|"Subject will perform the conditions as described under model description first without and then with the exoskeleton."
11308376|NCT03134144|BG001|Baseline|First With Exoskeleton Then Without|"Subject will perform the conditions as described under model description first with and then without the exoskeleton."
11308377|NCT03134144|BG002|Baseline|Total|Total of all reporting groups
11308378|NCT03134144|FG000|Participant Flow|First Without Exoskeleton Then With Exoskeleton|"Subject will perform the conditions as described under model description first with and then without the exoskeleton."
11308379|NCT03134144|FG001|Participant Flow|First With Exoskeleton and Then Without Exoskeleton|"Subject will perform the conditions as described under model description first with and then without the exoskeleton.~Exoskeleton Chairless Chair: One solution to reduce the exposure of employees to associated risks for developing work-related musculoskeletal disorders is to use exoskeletons. Using such a device in dynamic environments has the advantage over, e.g., robotics because it does not need any programming or teaching of robots. Moreover, exoskeletons are worn at the body and do not have to overcome spatial issues. In a recent review, 26 different exoskeletons have been described of which only two were designed to support the lower body during heavy work (de Looze et al. 2015). For lower intensive work tasks, like assembly tasks in the automobile industry, no study has focused on using exoskeletons to relieve employees while performing the work standing."
11308380|NCT03134144|OG000|Outcome|First Without Exoskeleton Then With Exoskeleton|"Subject will perform the conditions as described under model description first without the exoskeleton and then with the exoskeleton."
11308381|NCT03134144|OG001|Outcome|First With Exoskeleton and Then Without Exoskeleton|"Subject will perform the conditions as described under model description first with the exoskeleton and then without the exoskeleton."
11308382|NCT03134144|OG001|Outcome|First With Exoskeleton and Then Without the Exoskeleton|"Subject will perform the conditions as described under model description first with the exoskeleton and then without the exoskeleton."
11308383|NCT03134144|OG001|Outcome|First With Exoskeleton Then Without Exoskeleton|"Subject will perform the conditions as described under model description first with the exoskeleton and then without the exoskeleton."
11308384|NCT03134144|OG001|Outcome|First With Exoskeleton Then Without Exoskeleton|"Subject will perform the conditions as described under model description with the exoskeleton.~Exoskeleton Chairless Chair: One solution to reduce the exposure of employees to associated risks for developing work-related musculoskeletal disorders is to use exoskeletons. Using such a device in dynamic environments has the advantage over, e.g., robotics because it does not need any programming or teaching of robots. Moreover, exoskeletons are worn at the body and do not have to overcome spatial issues. In a recent review, 26 different exoskeletons have been described of which only two were designed to support the lower body during heavy work (de Looze et al. 2015). For lower intensive work tasks, like assembly tasks in the automobile industry, no study has focused on using exoskeletons to relieve employees while performing the work standing."
11308385|NCT03134144|OG000|Outcome|First Without Exoskeleton Then With Exoskeleton|"Subject will perform the conditions as described under model description first without and then with the exoskeleton."
11308386|NCT03134144|OG001|Outcome|First With Exoskeleton Then Without|"Subject will perform the conditions as described under model description first with and then without the exoskeleton."
11308387|NCT03134144|EG000|Reported Event|Without Exoskeleton|"Subject will perform the conditions as described under model description without the exoskeleton."
11308388|NCT03134144|EG001|Reported Event|With Exoskeleton|"Subject will perform the conditions as described under model description with the exoskeleton."
11333087|NCT03508661|OG000|Outcome|SPIN-SSLED Program|SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 &7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
11333088|NCT03508661|EG000|Reported Event|SPIN-SSLED Program|SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 &7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
10972068|NCT00919126|BG001|Baseline|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
11308389|NCT03134183|BG000|Baseline|Vaginal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository~Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E"
11308390|NCT03134183|BG001|Baseline|Buccal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder~Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E"
11308391|NCT03134183|BG002|Baseline|Total|Total of all reporting groups
11308392|NCT03134183|FG000|Participant Flow|Vaginal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository~Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E"
11308393|NCT03134183|FG001|Participant Flow|Buccal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder~Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E"
11308394|NCT03134183|OG000|Outcome|Vaginal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository~Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E"
11308395|NCT03134183|OG001|Outcome|Buccal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder~Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E"
11308396|NCT03134183|EG000|Reported Event|Vaginal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository~Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E"
11308397|NCT03134183|EG001|Reported Event|Buccal Misoprostol|"Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder~Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E"
11308398|NCT03134209|BG000|Baseline|Zipper Surgical Skin Closure|"Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty~Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin."
11308399|NCT03134209|BG001|Baseline|Monocryl + Dermabond|"Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.~Monocryl + Dermabond: conventional sutures and skin adhesive glue"
11308400|NCT03134209|BG002|Baseline|Polyester Mesh + Dermabond|"The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study~Polyester mesh + Dermabond: conventional sutures and skin adhesive glue"
11308401|NCT03134209|BG003|Baseline|Total|Total of all reporting groups
11308402|NCT03134209|FG000|Participant Flow|Zipper Surgical Skin Closure|"Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty~Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin."
11308403|NCT03134209|FG001|Participant Flow|Monocryl + Dermabond|"Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.~Monocryl + Dermabond: conventional sutures and skin adhesive glue"
11308404|NCT03134209|FG002|Participant Flow|Polyester Mesh + Dermabond|"The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study~Polyester mesh + Dermabond: conventional sutures and skin adhesive glue"
11308405|NCT03134209|OG000|Outcome|Zipper Surgical Skin Closure|"Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty~Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin."
11308406|NCT03134209|OG001|Outcome|Monocryl + Dermabond|"Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.~Monocryl + Dermabond: conventional sutures and skin adhesive glue"
11308407|NCT03134209|OG002|Outcome|Polyester Mesh + Dermabond|"The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study~Polyester mesh + Dermabond: conventional sutures and skin adhesive glue"
11308408|NCT03134209|EG000|Reported Event|Zipper Surgical Skin Closure|"Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty~Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin."
11308409|NCT03134209|EG001|Reported Event|Monocryl + Dermabond|"Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.~Monocryl + Dermabond: conventional sutures and skin adhesive glue"
10972069|NCT00919126|BG002|Baseline|Group C|Medical Air in Oxygen (45%-55%)
11308410|NCT03134209|EG002|Reported Event|Polyester Mesh + Dermabond|"The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study~Polyester mesh + Dermabond: conventional sutures and skin adhesive glue"
11308411|NCT03134222|BG000|Baseline|Lanraplenib 30 mg|Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
11308412|NCT03134222|BG001|Baseline|Filgotinib 200 mg|Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
11308413|NCT03134222|BG002|Baseline|Placebo|Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo or lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
11308414|NCT03134222|BG003|Baseline|Total|Total of all reporting groups
11308415|NCT03134222|FG000|Participant Flow|Lanraplenib 30 mg|Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
11308416|NCT03134222|FG001|Participant Flow|Filgotinib 200 mg|Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
11308417|NCT03134222|FG002|Participant Flow|Placebo|Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
11308418|NCT03134222|FG003|Participant Flow|Placebo to Lanraplenib 30 mg|After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
11308419|NCT03134222|FG004|Participant Flow|Placebo to Filgotinib 200 mg|After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
11308420|NCT03134222|OG000|Outcome|Lanraplenib 30 mg|Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
11308421|NCT03134222|OG001|Outcome|Filgotinib 200 mg|Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
11308422|NCT03134222|OG002|Outcome|Placebo|Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
11308423|NCT03134222|EG000|Reported Event|Lanraplenib 30 mg|Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
11308424|NCT03134222|EG001|Reported Event|Filgotinib 200 mg|Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
11308425|NCT03134222|EG002|Reported Event|Placebo|Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
11308426|NCT03134222|EG003|Reported Event|Placebo to Lanraplenib 30 mg|After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
11308427|NCT03134222|EG004|Reported Event|Placebo to Filgotinib 200 mg|After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
11308428|NCT03134248|BG000|Baseline|All Study Participants|A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Contact Lenses
11308429|NCT03134248|FG000|Participant Flow|1-Day AM First, Then DACP, Then MDT|1-day Acuvue Moist for Astig first, then Dailies Aquacomfort Plus, then MyDay Troic
11308430|NCT03134248|FG001|Participant Flow|1-Day AM First, Then MDT, Then DACP|1-day Acuvue Moist for Astig, then MyDay Toric, then Dailies Aquacomfort Plus
11308431|NCT03134248|FG002|Participant Flow|DACP First, Then 1-Day AM, Then MDT|Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig, then MyDay Toric
11308432|NCT03134248|FG003|Participant Flow|DACP First, Then MDT, Then 1-Day AM|Dailies Aquacomfort Plus, then MyDay Toric, then 1-day Acuvue Moist for Astig
11308433|NCT03134248|FG004|Participant Flow|MDT First, Then 1-Day AM, Then DACP|MyDay Toric, then 1-day Acuvue Moist for Astig, then Dailies Aquacomfort Plus
11308434|NCT03134248|FG005|Participant Flow|MDT First, Then DACP, Then 1-Day AM|MyDay Toric, then Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig
11308435|NCT03134248|OG000|Outcome|MyDay Toric Contact Lens|Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
11308436|NCT03134248|OG001|Outcome|1-Day Acuvue Moist for Astigmatism Contact Lens|Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
11308437|NCT03134248|OG002|Outcome|Dailies Aquacomfort Plus Toric Contact Lens|Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
11308438|NCT03134248|OG000|Outcome|Overall Study|Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses
11308439|NCT03134248|OG000|Outcome|Overall Study|A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Lenses
11308440|NCT03134248|EG000|Reported Event|MyDay Toric|Participants who wore MyDay Toric contact lenses
11308441|NCT03134248|EG001|Reported Event|1-Day Acuvue Moist for Astigmatism|Participants who wore 1-Day Acuvue Moist for Astigmatism contact lenses
11308442|NCT03134248|EG002|Reported Event|Dailies Aqua Comfort Plus Toric|Participants who wore Dailies Aqua Comfort Plus Toric contact lenses
11308443|NCT03134313|BG000|Baseline|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor~Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
10972070|NCT00919126|BG003|Baseline|Total|Total of all reporting groups
11308444|NCT03134313|FG000|Participant Flow|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor~Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
11308445|NCT03134313|OG000|Outcome|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
11308446|NCT03134313|EG000|Reported Event|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
11308447|NCT03134326|BG000|Baseline|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
11308448|NCT03134326|FG000|Participant Flow|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
11308449|NCT03134326|OG000|Outcome|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
11308450|NCT03134326|EG000|Reported Event|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
11308451|NCT03134599|BG000|Baseline|All Study Participants|All study participants wore enfilcon A, methafilcon A (Interozzo) and methafilcon A (CooperVision) contact lenses.
11308452|NCT03134599|FG000|Participant Flow|Etafilcon A, Methafilcon A-Interozzo, Methafilcon A (CVI)|etafilcon A first, then methafilcon A - Interozzo then methafilcon A (CVI) contact lens
11308453|NCT03134599|FG001|Participant Flow|Etafilcon A, Methafilcon A (CVI), Methafilcon A-Interozzo|etafilcon A first, then methafilcon A (CVI) then methafilcon A - Interozzo contact lens
11308454|NCT03134599|FG002|Participant Flow|Methafilcon A-Interozzo, Methafilcon A (CVI), Etafilcon A|methafilcon A - Interozzo first, then methafilcon A (CVI), then etafilcon A contact lens
11308455|NCT03134599|FG003|Participant Flow|Methafilcon A-Interozzo, Etafilcon A Methafilcon A (CVI)|methafilcon A - Interozzo first, then etafilcon A contact lens, then methafilcon A (CVI)
11308456|NCT03134599|FG004|Participant Flow|Methafilcon A (CVI), Methafilcon A-Interozzo, Etafilcon A|methafilcon A (CVI) first, then methafilcon A - Interozzo, then etafilcon A contact lens
11308457|NCT03134599|FG005|Participant Flow|Methafilcon A (CVI), Etafilcon A, Methafilcon A-Interozzo|methafilcon A (CVI) first, then etafilcon A contact lens, then methafilcon A - Interozzo
11308458|NCT03134599|OG000|Outcome|Etafilcon A|etafilcon A contact lens
11308459|NCT03134599|OG001|Outcome|Methafilcon A - Interozzo|methafilcon A - Interozzo: contact lens
11308460|NCT03134599|OG002|Outcome|Methafilcon A - CVI|methafilcon A - CVI (CooperVision): contact lens
11308461|NCT03134599|EG000|Reported Event|Etafilcon A|All subjects who wore etafilcon A contact lenses as either the first, second or third pair.
11308462|NCT03134599|EG001|Reported Event|Methafilcon A-Interozzo|All subjects who wore methafilcon A-Interozzo contact lenses as either the first, second or third pair.
11308463|NCT03134599|EG002|Reported Event|Methafilcon A (CVI)|All subjects who wore methafilcon A (CVI) contact lenses as either the first, second or third pair.
11308464|NCT03134703|BG000|Baseline|Methadone Treatment Group|"NAS infants treated for withdrawal symptoms with methadone~Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308465|NCT03134703|BG001|Baseline|Comparison Group|"NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)~Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308466|NCT03134703|BG002|Baseline|Total|Total of all reporting groups
11308467|NCT03134703|FG000|Participant Flow|Methadone Treatment Group|"NAS infants treated for withdrawal symptoms with methadone~Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308468|NCT03134703|FG001|Participant Flow|Comparison Group|"NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)~Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308469|NCT03134703|OG000|Outcome|Methadone Treatment Group|"NAS infants treated for withdrawal symptoms with methadone~Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308470|NCT03134703|OG001|Outcome|Comparison Group|"NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)~Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308471|NCT03134703|EG000|Reported Event|Methadone Treatment Group|"NAS infants treated for withdrawal symptoms with methadone~Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308472|NCT03134703|EG001|Reported Event|Comparison Group|"NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)~Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"
11308473|NCT03134768|BG000|Baseline|Vaginally Born Children|Cord blood samples collected from vaginally born children
11308474|NCT03134768|FG000|Participant Flow|Vaginally Born Children|Cord blood samples collected from vaginally born children
11308475|NCT03134768|OG000|Outcome|Vaginally Born Children|Cord blood samples collected from vaginally born children
11308476|NCT03134768|EG000|Reported Event|Vaginally Born Children|Cord blood samples collected from vaginally born children
11308477|NCT03134911|BG000|Baseline|Uncontrolled Group|Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
11308478|NCT03134911|BG001|Baseline|Controlled Group|Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
11308479|NCT03134911|BG002|Baseline|Total|Total of all reporting groups
11308480|NCT03134911|FG000|Participant Flow|Total Patients With Non-valvular Atrial Fibrillation|Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment with uncontrolled anticoagulation status and VKA or direct oral anticoagulant (DOAC) treatment with controlled anticoagulation status were included. For both the groups treatment were given for at least 6 months and up to 2 years.
11308481|NCT03134911|OG000|Outcome|Controlled Group|Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
11308482|NCT03134911|OG001|Outcome|Uncontrolled Group|Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
11308483|NCT03134911|OG000|Outcome|Uncontrolled Group|Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
11308484|NCT03134911|EG000|Reported Event|Uncontrolled Group|Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
11308485|NCT03134911|EG001|Reported Event|VKA Controlled Group|Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
11308486|NCT03134911|EG002|Reported Event|DOAC Controlled Group|Patients with non-valvular atrial fibrillation (NVAF), who received direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
11308487|NCT03134963|BG000|Baseline|Mild Cognitive Impairment|"MCI Patient-specific Inclusion Criteria~Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:~Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant~Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.~Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions~Not demented~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308488|NCT03134963|BG001|Baseline|Alzheimer Disease|"NIA/AA criteria~Meets the criteria for dementia~o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains~Insidious or gradual onset~Clear history of worsening cognition by report or observation~The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:~Amnestic: impaired learning and recall of recently learned information~Non amnestic: language/visuospatial/executive dysfunction~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308489|NCT03134963|BG002|Baseline|Vascular Dementia|"NINDS-AIREN criteria for VascD, specifically:~Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.~One or more of:~Onset of dementia within 3 months of a diagnosed stroke~Abrupt deterioration in cognitive function~Fluctuating, stepwise progression of cognitive deficits~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308490|NCT03134963|BG003|Baseline|Healthy Controls|"Healthy Controls-specific Inclusion Criteria~No evidence of subjective or objective memory impairment on cognitive testing~No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308491|NCT03134963|BG004|Baseline|Total|Total of all reporting groups
10848537|NCT00290329|EG002|Reported Event|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
11308492|NCT03134963|FG000|Participant Flow|Mild Cognitive Impairment|"MCI Patient-specific Inclusion Criteria~Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:~Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant~Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.~Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions~Not demented~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308493|NCT03134963|FG001|Participant Flow|Alzheimer Disease|"NIA/AA criteria~Meets the criteria for dementia~o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains~Insidious or gradual onset~Clear history of worsening cognition by report or observation~The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:~Amnestic: impaired learning and recall of recently learned information~Non amnestic: language/visuospatial/executive dysfunction~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308494|NCT03134963|FG002|Participant Flow|Vascular Dementia|"NINDS-AIREN criteria for VascD, specifically:~Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.~One or more of:~Onset of dementia within 3 months of a diagnosed stroke~Abrupt deterioration in cognitive function~Fluctuating, stepwise progression of cognitive deficits~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308495|NCT03134963|FG003|Participant Flow|Healthy Controls|"Healthy Controls-specific Inclusion Criteria~No evidence of subjective or objective memory impairment on cognitive testing~No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308496|NCT03134963|OG000|Outcome|Mild Cognitive Impairment|"MCI Patient-specific Inclusion Criteria~Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:~Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant~Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.~Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions~Not demented~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308497|NCT03134963|OG001|Outcome|Alzheimer Disease|"NIA/AA criteria~Meets the criteria for dementia~o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains~Insidious or gradual onset~Clear history of worsening cognition by report or observation~The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:~Amnestic: impaired learning and recall of recently learned information~Non amnestic: language/visuospatial/executive dysfunction~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308498|NCT03134963|OG002|Outcome|Vascular Dementia|"NINDS-AIREN criteria for VascD, specifically:~Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.~One or more of:~Onset of dementia within 3 months of a diagnosed stroke~Abrupt deterioration in cognitive function~Fluctuating, stepwise progression of cognitive deficits~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308499|NCT03134963|OG003|Outcome|Healthy Controls|"Healthy Controls-specific Inclusion Criteria~No evidence of subjective or objective memory impairment on cognitive testing~No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11333089|NCT03508687|BG000|Baseline|Group 1: 300 mg Gemcabene Daily Week 1-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene"
10972071|NCT00919126|FG000|Participant Flow|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
11308500|NCT03134963|EG000|Reported Event|Mild Cognitive Impairment|"MCI Patient-specific Inclusion Criteria~Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:~Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant~Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.~Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions~Not demented~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308501|NCT03134963|EG001|Reported Event|Alzheimer Disease|"NIA/AA criteria~Meets the criteria for dementia~o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains~Insidious or gradual onset~Clear history of worsening cognition by report or observation~The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:~Amnestic: impaired learning and recall of recently learned information~Non amnestic: language/visuospatial/executive dysfunction~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308502|NCT03134963|EG002|Reported Event|Vascular Dementia|"NINDS-AIREN criteria for VascD, specifically:~Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.~One or more of:~Onset of dementia within 3 months of a diagnosed stroke~Abrupt deterioration in cognitive function~Fluctuating, stepwise progression of cognitive deficits~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308503|NCT03134963|EG003|Reported Event|Healthy Controls|"Healthy Controls-specific Inclusion Criteria~No evidence of subjective or objective memory impairment on cognitive testing~No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition~Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.~Blood pressure monitoring: Continuous blood pressure recording~Heart rate monitoring: Continuous heart rate monitoring~End tidal CO2 monitoring: Continuous ETCO2 monitoring~Addenbrooke's cognitive examination: Performance of a memory test"
11308504|NCT03134989|BG000|Baseline|Adults Implanted With CI522, CI532, CI622, CI632 or Hybrid-L24 (US Only)|Adults (≥ 18 years of age) implanted with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) with pre-operative audiometric threshold in the ear to be implanted of better than or equal to 80 dB HL at the frequency of 500 Hz.
11308505|NCT03134989|FG000|Participant Flow|Adults Implanted With CI522, CI532, CI622, CI632 or Hybrid-L24 (US Only)|Adults (≥ 18 years of age) implanted with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) with pre-operative audiometric threshold in the ear to be implanted of better than or equal to 80 dB HL at the frequency of 500 Hz.
11308506|NCT03134989|OG000|Outcome|Cochlear Implant Recipients|"Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.~Cochlear implant: Study involves using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery"
11308507|NCT03134989|OG000|Outcome|Cochlear Implant Recipients|"Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.~Cochlear implant: Study involves Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery"
11308508|NCT03134989|EG000|Reported Event|Cochlear Implant Recipients|"Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.~Cochlear implant: Study involves measuring cochlear response electrophysiologically during surgery to place a cochlear implant in patients already identified as candidates."
11308509|NCT03135015|BG000|Baseline|Lean Participants|Participants with BMI >18.5 and <25.0kg/m². All participants received each of the 6 interventions in a randomized manner.
11308510|NCT03135015|BG001|Baseline|Overweight/Obese Participants|Participants with BMI ≥25.0 and <35.0kg/m². All participants received each of the 6 interventions in a randomized manner.
11308511|NCT03135015|BG002|Baseline|Total|Total of all reporting groups
11308512|NCT03135015|FG000|Participant Flow|Lean Participants|Participants with BMI >18.5 and <25.0kg/m². All participants received each of the 6 interventions in a randomized manner.
11308513|NCT03135015|FG001|Participant Flow|Overweight/Obese Participants|Participants with BMI ≥25.0 and <35.0kg/m². All participants received each of the 6 interventions in a randomized manner.
11308514|NCT03135015|OG000|Outcome|Water Control|All Participants randomized to receive 250ml water.
11308515|NCT03135015|OG001|Outcome|2g Capsules|All Participants randomized to receive 250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308516|NCT03135015|OG002|Outcome|4g Capsules|All Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308517|NCT03135015|OG003|Outcome|Placebo Capsules|All Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308518|NCT03135015|OG004|Outcome|2g Tablets|All Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308519|NCT03135015|OG005|Outcome|4g Tablets|All Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308520|NCT03135015|OG001|Outcome|2g Capsules|All Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308521|NCT03135015|OG000|Outcome|Water Control, Lean Participants|Lean Participants randomized to receive 250ml water.
10972072|NCT00919126|FG001|Participant Flow|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
10972073|NCT00919126|FG002|Participant Flow|Group C|Medical Air in Oxygen (45%-55%)
11308522|NCT03135015|OG001|Outcome|Water Control, Overweight Participants|Overweight Participants randomized to receive 250ml water.
11308523|NCT03135015|OG002|Outcome|2g Capsules, Lean Participants|Lean Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308524|NCT03135015|OG003|Outcome|2g Capsules, Overweight Participants|Overweight Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308525|NCT03135015|OG004|Outcome|4g Capsules, Lean Participants|Lean Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308526|NCT03135015|OG005|Outcome|4g Capsules, Overweight Participants|Overweight Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308527|NCT03135015|OG006|Outcome|2g Tablets, Lean Participants|Lean Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308528|NCT03135015|OG007|Outcome|2g Tablets, Overweight Participants|Overweight Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308529|NCT03135015|OG008|Outcome|4g Tablets, Lean Participants|Lean Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308530|NCT03135015|OG009|Outcome|4g Tablets, Overweight Participants|Overweight Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308531|NCT03135015|OG010|Outcome|Placebo Capsules, Lean Participants|Lean Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308532|NCT03135015|OG011|Outcome|Placebo Capsules, Overweight Participants|Overweight Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308533|NCT03135015|OG002|Outcome|2g Tablets|All Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308534|NCT03135015|OG003|Outcome|4g Capsules|All Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
10848538|NCT00290342|BG000|Baseline|Infanrix-IPV Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
10972074|NCT00919126|OG000|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
11308535|NCT03135015|OG004|Outcome|4g Tablets|All Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308536|NCT03135015|OG005|Outcome|Placebo Capsules|All Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308537|NCT03135015|OG001|Outcome|Placebo Capsules|All Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308538|NCT03135015|OG000|Outcome|Water Control|Lean Participants randomized to receive 250ml water.
11308539|NCT03135015|OG001|Outcome|2g Capsules|Lean Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308540|NCT03135015|OG002|Outcome|4g Capsules|Lean Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
10972075|NCT00919126|OG001|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
11308541|NCT03135015|OG003|Outcome|Placebo Capsules|Lean Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308542|NCT03135015|OG004|Outcome|2g Tablets|Lean Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308543|NCT03135015|OG005|Outcome|4g Tablets|Lean Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308544|NCT03135015|OG000|Outcome|Water Control|Overweight Participants randomized to receive 250ml water.
11308545|NCT03135015|OG001|Outcome|2g Capsules|Overweight Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308546|NCT03135015|OG002|Outcome|4g Capsules|Overweight Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308547|NCT03135015|OG003|Outcome|Placebo Capsules|Overweight Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308548|NCT03135015|OG004|Outcome|2g Tablets|Overweight Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308549|NCT03135015|OG005|Outcome|4g Tablets|Overweight Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308550|NCT03135015|EG000|Reported Event|Water Control, Lean Participants|Participants randomized to receive 250ml water.
11308551|NCT03135015|EG001|Reported Event|Water Control, Overweight/Obese Participants|Participants randomized to receive 250ml water.
11308552|NCT03135015|EG002|Reported Event|Placebo Capsules, Lean Participants|Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308553|NCT03135015|EG003|Reported Event|Placebo Capsules, Overweight/Obese Participants|Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.
11308554|NCT03135015|EG004|Reported Event|2g Capsules, Lean Participants|Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308555|NCT03135015|EG005|Reported Event|2g Capsules, Overweight/Obese Participants|Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.
11308556|NCT03135015|EG006|Reported Event|4g Capsules, Lean Participants|Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308557|NCT03135015|EG007|Reported Event|4g Capsules, Overweight/Obese Participants|Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.
11308558|NCT03135015|EG008|Reported Event|2g Tablets, Lean Participants|Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308559|NCT03135015|EG009|Reported Event|2g Tablets, Overweight/Obese Participants|Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.
11308560|NCT03135015|EG010|Reported Event|4g Tablets, Lean Participants|Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308561|NCT03135015|EG011|Reported Event|4g Tablets, Overweight/Obese Participants|Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.
11308562|NCT03135028|BG000|Baseline|ENTO 400 mg|Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
11308563|NCT03135028|FG000|Participant Flow|ENTO 400 mg|Participants received entospletinib (ENTO) 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
11308564|NCT03135028|OG000|Outcome|ENTO 400 mg|Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
11308565|NCT03135028|EG000|Reported Event|ENTO 400 mg|Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
11308566|NCT03135210|BG000|Baseline|Open-Chain Leg Exercise|"Individuals in the open-chain group will progress through standard mobility progression.~Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression."
11308567|NCT03135210|BG001|Baseline|Closed-Chain Leg Exercise|"Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.~Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform."
11308568|NCT03135210|BG002|Baseline|Total|Total of all reporting groups
11308569|NCT03135210|FG000|Participant Flow|Open-Chain Leg Exercise|"Individuals in the open-chain group will progress through standard mobility progression.~Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression."
11308570|NCT03135210|FG001|Participant Flow|Closed-Chain Leg Exercise|"Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.~Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform."
11308571|NCT03135210|OG000|Outcome|Open-Chain Leg Exercise|"Individuals in the open-chain group will progress through standard mobility progression.~Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression."
11308572|NCT03135210|OG001|Outcome|Closed-Chain Leg Exercise|"Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.~Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform."
11308573|NCT03135210|EG000|Reported Event|Open-Chain Leg Exercise|"Individuals in the open-chain group will progress through standard mobility progression.~Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression."
11308574|NCT03135210|EG001|Reported Event|Closed-Chain Leg Exercise|"Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.~Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform."
11308575|NCT03135379|BG000|Baseline|Heated Gel|"Patient undergoes ultrasound study using the intervention of heated ultrasound gel.~Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit)."
11308576|NCT03135379|BG001|Baseline|Room Temperature Gel|"Patient undergoes ultrasound study using the intervention of room temperature gel.~Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off."
11308577|NCT03135379|BG002|Baseline|Total|Total of all reporting groups
11308578|NCT03135379|FG000|Participant Flow|Heated Gel|"Patient undergoes ultrasound study using the intervention of heated ultrasound gel.~Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit)."
11308579|NCT03135379|FG001|Participant Flow|Room Temperature Gel|"Patient undergoes ultrasound study using the intervention of room temperature gel.~Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off."
11308580|NCT03135379|OG000|Outcome|Heated Gel|"Patient undergoes ultrasound study using the intervention of heated ultrasound gel.~Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit)."
10972076|NCT00919126|OG002|Outcome|Group C|Medical Air in Oxygen (45%-55%)
11308581|NCT03135379|OG001|Outcome|Room Temperature Gel|"Patient undergoes ultrasound study using the intervention of room temperature gel.~Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off."
11308582|NCT03135379|EG000|Reported Event|Heated Gel|"Patient undergoes ultrasound study using the intervention of heated ultrasound gel.~Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit)."
11308583|NCT03135379|EG001|Reported Event|Room Temperature Gel|"Patient undergoes ultrasound study using the intervention of room temperature gel.~Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off."
11308584|NCT03135431|BG000|Baseline|Salpingectomy|"Bilateral salpingectomy following cesarean delivery~Bilateral Salpingectomy: Surgical removal of entire fallopian tubes"
11308585|NCT03135431|BG001|Baseline|Tubal Ligation|"Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.~Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes"
11308586|NCT03135431|BG002|Baseline|Total|Total of all reporting groups
11308587|NCT03135431|FG000|Participant Flow|Salpingectomy|"Bilateral salpingectomy following cesarean delivery~Bilateral Salpingectomy: Surgical removal of entire fallopian tubes"
11308588|NCT03135431|FG001|Participant Flow|Tubal Ligation|"Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.~Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes"
11308589|NCT03135431|OG000|Outcome|Salpingectomy|"Bilateral salpingectomy following cesarean delivery~Bilateral Salpingectomy: Surgical removal of entire fallopian tubes"
11308590|NCT03135431|OG001|Outcome|Tubal Ligation|"Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.~Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes"
11308591|NCT03135431|EG000|Reported Event|Salpingectomy|Bilateral salpingectomy (surgical removal or entire fallopian tubes) following cesarean delivery
11308592|NCT03135431|EG001|Reported Event|Tubal Ligation|Bilateral tubal ligation (surgical tying, cutting, or removal of a portion of the fallopian tubes)following cesarean delivery via Parkland or modified Pomeroy methods.
11308593|NCT03135522|BG000|Baseline|Zinc Acetate 50 mg Oral Capsule|"50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Zinc Acetate 50 Mg Oral Capsule: • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)~Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)~Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)"
11308594|NCT03135522|BG001|Baseline|Placebo Oral Capsule|"Placebo matched to zinc acetate 50 mg oral capsule active arm, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Placebo oral capsule: • Day 0 (randomization) to day 3 Placebo (one capsule per day)~Day 4 to day 7 If well tolerated: placebo (two capsules per day)~Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)"
11308595|NCT03135522|BG002|Baseline|Total|Total of all reporting groups
11308596|NCT03135522|FG000|Participant Flow|Zinc Acetate 50 mg Oral Capsule|"50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Zinc Acetate 50 Mg Oral Capsule: • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)~Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)~Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)"
11308597|NCT03135522|FG001|Participant Flow|Placebo Oral Capsule|"Placebo matched to zinc acetate 50 mg oral capsule active arm, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Placebo oral capsule: • Day 0 (randomization) to day 3 Placebo (one capsule per day)~Day 4 to day 7 If well tolerated: placebo (two capsules per day)~Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)"
11308598|NCT03135522|OG000|Outcome|Zinc Acetate 50 mg Oral Capsule|"50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Zinc Acetate 50 Mg Oral Capsule: • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)~Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)~Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)"
11308599|NCT03135522|OG001|Outcome|Placebo Oral Capsule|"Placebo matched to zinc acetate 50 mg oral capsule active arm, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Placebo oral capsule: • Day 0 (randomization) to day 3 Placebo (one capsule per day)~Day 4 to day 7 If well tolerated: placebo (two capsules per day)~Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)"
11308600|NCT03135522|EG000|Reported Event|Zinc Acetate 50 mg Oral Capsule|"50 mg zinc acetate oral capsules, over-encapsulated, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Zinc Acetate 50 Mg Oral Capsule: • Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)~Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)~Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)"
11308601|NCT03135522|EG001|Reported Event|Placebo Oral Capsule|"Placebo matched to zinc acetate 50 mg oral capsule active arm, administered starting at 1 capsule/day and escalated to 3 capsules/day by Day 8 post-randomization (if tolerated)~Placebo oral capsule: • Day 0 (randomization) to day 3 Placebo (one capsule per day)~Day 4 to day 7 If well tolerated: placebo (two capsules per day)~Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)"
11333090|NCT03508687|BG001|Baseline|Group 2: 600mg Gemcabene Daily Week 12-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene"
11333091|NCT03508687|BG002|Baseline|Total|Total of all reporting groups
11333092|NCT03508687|FG000|Participant Flow|Group 1: 300 mg Gemcabene Daily Week 1-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene"
11333093|NCT03508687|FG001|Participant Flow|Group 2: 600mg Gemcabene Daily Week 12-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene"
11333094|NCT03508687|OG000|Outcome|Group 1: 300 mg Gemcabene Daily Week 1-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene"
11308602|NCT03135535|BG000|Baseline|Avex Footbeat|"Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.~Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion."
11308603|NCT03135535|FG000|Participant Flow|Avex Footbeat|"Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.~Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion."
11308604|NCT03135535|OG000|Outcome|Avex Footbeat|"Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.~Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion."
11308605|NCT03135535|EG000|Reported Event|Avex Footbeat|"Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.~Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion."
11308606|NCT03135548|BG000|Baseline|BI 655130 Low Dose|Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308607|NCT03135548|BG001|Baseline|BI 655130 High Dose|Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308608|NCT03135548|BG002|Baseline|Placebo Matching to BI 655130|Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308609|NCT03135548|BG003|Baseline|Total|Total of all reporting groups
11308610|NCT03135548|FG000|Participant Flow|BI 655130 Low Dose|Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308611|NCT03135548|FG001|Participant Flow|BI 655130 High Dose|Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308612|NCT03135548|FG002|Participant Flow|Placebo Matching to BI 655130|Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308613|NCT03135548|OG000|Outcome|BI 655130 Low Dose|Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308614|NCT03135548|OG001|Outcome|BI 655130 High Dose|Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308615|NCT03135548|OG002|Outcome|Placebo Matching to BI 655130|Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308616|NCT03135548|EG000|Reported Event|BI 655130 Low Dose|Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308617|NCT03135548|EG001|Reported Event|BI 655130 High Dose|Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308618|NCT03135548|EG002|Reported Event|Placebo Matching to BI 655130|Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
11308619|NCT03135899|BG000|Baseline|Placebo/BI 443651 100/400/1200 Micro Gram (μg) - Part 1|Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 micro gram (μg) inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308620|NCT03135899|BG001|Baseline|BI 443651 100 μg/Placebo/BI 443651 400/1200 μg - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
10972077|NCT00919126|OG001|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
10972078|NCT00919126|EG000|Reported Event|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
10972079|NCT00919126|EG001|Reported Event|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
11308621|NCT03135899|BG002|Baseline|BI 443651 100/400 μg/Placebo/BI 443651 1200 μg - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308622|NCT03135899|BG003|Baseline|BI 443651 100/400/1200 μg/Placebo - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308623|NCT03135899|BG004|Baseline|Placebo/BI 443651 100/400/1200 μg - Part 2|Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 μg inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308624|NCT03135899|BG005|Baseline|BI 443651 400/1200 μg/Placebo/BI 443651 100 μg - Part 2|Patients were orally administered BI 443651 400 μg inhalation solution in period 1, followed by BI 443651 1200 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 100 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308625|NCT03135899|BG006|Baseline|BI 443651 100 μg/Placebo/BI 443651 1200/400 μg - Part 2|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and BI 443651 400 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308626|NCT03135899|BG007|Baseline|BI 443651 1200/400/100 μg/Placebo - Part 2|Patients were orally administered BI 443651 1200 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 100 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308627|NCT03135899|BG008|Baseline|Total|Total of all reporting groups
11308628|NCT03135899|FG000|Participant Flow|Placebo/BI 443651 100/400/1200 Micro Gram (μg) - Part 1|Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 micro gram (μg) inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308629|NCT03135899|FG001|Participant Flow|BI 443651 100 μg/Placebo/BI 443651 400/1200 μg - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308630|NCT03135899|FG002|Participant Flow|BI 443651 100/400 μg/Placebo/BI 443651 1200 μg - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308631|NCT03135899|FG003|Participant Flow|BI 443651 100/400/1200 μg/Placebo - Part 1|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308632|NCT03135899|FG004|Participant Flow|Placebo/BI 443651 100/400/1200 μg - Part 2|Patients were orally administered placebo matched to BI 443651 inhalation solution in period 1, followed by BI 443651 100 μg inhalation solution in period 2, BI 443651 400 μg inhalation solution in period 3 and BI 443651 1200 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308633|NCT03135899|FG005|Participant Flow|BI 443651 400/1200 μg/Placebo/BI 443651 100 μg - Part 2|Patients were orally administered BI 443651 400 μg inhalation solution in period 1, followed by BI 443651 1200 μg inhalation solution in period 2, placebo matched to BI 443651 inhalation solution in period 3 and BI 443651 100 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308634|NCT03135899|FG006|Participant Flow|BI 443651 100 μg/Placebo/BI 443651 1200/400 μg - Part 2|Patients were orally administered BI 443651 100 μg inhalation solution in period 1, followed by placebo matched to BI 443651 inhalation solution in period 2, BI 443651 1200 μg inhalation solution in period 3 and BI 443651 400 μg inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
11308635|NCT03135899|FG007|Participant Flow|BI 443651 1200/400/100 μg/Placebo - Part 2|Patients were orally administered BI 443651 1200 μg inhalation solution in period 1, followed by BI 443651 400 μg inhalation solution in period 2, BI 443651 100 μg inhalation solution in period 3 and placebo matched to BI 443651 inhalation solution in period 4, each treatment was administered via Respimat® inhaler. All treatment periods were separated by a washout period of 14-28 days.
10972080|NCT00919126|EG002|Reported Event|Group C|Medical Air in Oxygen (45%-55%)
11308636|NCT03135899|OG000|Outcome|Placebo - Part 1|Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
11308637|NCT03135899|OG001|Outcome|BI 443651 100 μg - Part 1|Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308638|NCT03135899|OG002|Outcome|BI 443651 400 μg - Part 1|Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308639|NCT03135899|OG003|Outcome|BI 443651 1200 μg - Part 1|Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
11308640|NCT03135899|OG000|Outcome|Placebo - Part 2|Patients were orally administered 4 actuations, thrice 12 hours (h) apart, of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
11308641|NCT03135899|OG001|Outcome|BI 443651 100 μg - Part 2|Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308642|NCT03135899|OG002|Outcome|BI 443651 400 μg - Part 2|Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308643|NCT03135899|OG003|Outcome|BI 443651 1200 μg - Part 2|Patients were orally administered 4 actuations, thrice 12 h apart, of BI 443651 300 μg inhalation solution via Respimat® inhaler.
11308644|NCT03135899|EG000|Reported Event|Placebo - Part 1 & Part 2|Patients were orally administered 4 actuations of placebo matched with BI 443651 inhalation solution via Respimat® inhaler.
11308645|NCT03135899|EG001|Reported Event|BI 443651 100 Microgram (μg) - Part 1 & Part 2|Patients were orally administered 1 actuation of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308646|NCT03135899|EG002|Reported Event|BI 443651 400 μg - Part 1 & Part 2|Patients were orally administered 4 actuations of BI 443651 100 μg inhalation solution via Respimat® inhaler.
11308647|NCT03135899|EG003|Reported Event|BI 443651 1200 μg - Part 1 & Part 2|Patients were orally administered 4 actuations of BI 443651 300 μg inhalation solution via Respimat® inhaler.
11308648|NCT03136068|BG000|Baseline|Digoxin|"Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance~Digoxin: Trans-abdominal injection"
11308649|NCT03136068|BG001|Baseline|Placebo|"Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume~Placebo: Trans-abdominal injection"
11308650|NCT03136068|BG002|Baseline|Total|Total of all reporting groups
11308651|NCT03136068|FG000|Participant Flow|Digoxin|"Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance~Digoxin: Trans-abdominal injection"
11308652|NCT03136068|FG001|Participant Flow|Placebo|"Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume~Placebo: Trans-abdominal injection"
11308653|NCT03136068|OG000|Outcome|Digoxin|"Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance~Digoxin: Trans-abdominal injection"
11308654|NCT03136068|OG001|Outcome|Placebo|"Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume~Placebo: Trans-abdominal injection"
11308655|NCT03136068|EG000|Reported Event|Digoxin|"Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance~Digoxin: Trans-abdominal injection"
11308656|NCT03136068|EG001|Reported Event|Placebo|"Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume~Placebo: Trans-abdominal injection"
11308657|NCT03136107|BG000|Baseline|All Participants|Baseline population included safety population (N=26), safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule.
11308658|NCT03136107|FG000|Participant Flow|All Participants|There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule. All participants who were randomized to receive the study treatments were included.
11308659|NCT03136107|OG000|Outcome|Test Product|This arm included all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) was applied.
11308660|NCT03136107|OG001|Outcome|Reference Product|This arm included all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) was applied.
11308661|NCT03136107|EG000|Reported Event|Test Product|This arm included all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) was applied.
11308662|NCT03136107|EG001|Reported Event|Reference Product|This arm included all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) was applied.
11308663|NCT03136107|EG002|Reported Event|Negative Control|This arm included all the test sites on the participants back which were left unprotected.
11308664|NCT03136107|EG003|Reported Event|All Participants|Safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule.
11308665|NCT03136159|BG000|Baseline|Silver-impregnated Antimicrobial Dressing|"All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.~Silver-impregnated antimicrobial dressing: All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days."
11308666|NCT03136159|BG001|Baseline|Standard Dressing|"Those who had a primary csection with transverse incision and subcuticular closure but who had declined to receive the silver dressing.~Standard dressing: Telfa antimicrobial non-adherent island dressing covered with 10 sterile 4X4 gauge sponges secured wityh Tegaderm film tape. Dressing removed postop day 1 per routine."
11308667|NCT03136159|BG002|Baseline|Total|Total of all reporting groups
11308668|NCT03136159|FG000|Participant Flow|Silver Dressing Group|Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing
11308669|NCT03136159|FG001|Participant Flow|Standard Dressing Group|Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
11308670|NCT03136159|OG000|Outcome|Silver Dressing Group|Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing
11308671|NCT03136159|OG001|Outcome|Standard Dressing Group|Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
11308672|NCT03136159|EG000|Reported Event|Silver Dressing Group|Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing
11308673|NCT03136159|EG001|Reported Event|Standard Dressing Group|Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
11308674|NCT03136198|BG000|Baseline|LUS-guided Strategy-of-care|"Patients randomized to the LUS strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.~LUS-guided strategy-of-care: For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.~Treatment protocol:~IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.~Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)~Reassessment every 2 hours~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308675|NCT03136198|BG001|Baseline|Usual Care|"Patients randomized to the usual care arm will also undergo lung ultrasound assessments. However, these results will not be revealed to the care team. Patients will receive treatment per usual, standard care.~Usual Care: Patients will receive usual AHF care~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308676|NCT03136198|BG002|Baseline|Total|Total of all reporting groups
11308677|NCT03136198|FG000|Participant Flow|LUS-guided Strategy-of-care|"Patients randomized to the lung ultrasound (LUS) strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.~LUS-guided strategy-of-care: For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.~Treatment protocol:~IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.~Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)~Reassessment every 2 hours~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308678|NCT03136198|FG001|Participant Flow|Usual Care|"Patients randomized to the usual care arm will also undergo lung ultrasound assessments. However, these results will not be revealed to the care team. Patients will receive treatment per usual, standard care.~Usual Care: Patients will receive usual AHF care~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308679|NCT03136198|OG000|Outcome|LUS-guided Strategy-of-care|"Patients randomized to the LUS strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.~LUS-guided strategy-of-care: For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.~Treatment protocol:~IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.~Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)~Reassessment every 2 hours~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308680|NCT03136198|OG001|Outcome|Usual Care|"Patients randomized to the usual care arm will also undergo lung ultrasound assessments. However, these results will not be revealed to the care team. Patients will receive treatment per usual, standard care.~Usual Care: Patients will receive usual AHF care~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11333095|NCT03508687|OG001|Outcome|Group 2: 600mg Gemcabene Daily Week 12-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene"
11308681|NCT03136198|EG000|Reported Event|LUS-guided Strategy-of-care|"Patients randomized to the LUS strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.~LUS-guided strategy-of-care: For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.~Treatment protocol:~IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.~Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)~Reassessment every 2 hours~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308682|NCT03136198|EG001|Reported Event|Usual Care|"Patients randomized to the usual care arm will also undergo lung ultrasound assessments. However, these results will not be revealed to the care team. Patients will receive treatment per usual, standard care.~Usual Care: Patients will receive usual AHF care~Intravenous Loop Diuretic: IV loop diuretic~Vasodilator: IV, topical, or SL Vasodilator~Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation"
11308683|NCT03136328|BG000|Baseline|68Ga-DOTATOC PET/CT|Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis.
11308684|NCT03136328|FG000|Participant Flow|68Ga-DOTATOC PET/CT|Study participants will receive Gallium 68 (68Ga)-DOTATOC and undergo a PET/CT imaging study.
11308685|NCT03136328|OG000|Outcome|68Ga-DOTATOC PET/CT|Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
11308686|NCT03136328|OG001|Outcome|Conventional Imaging|All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging.
11308687|NCT03136328|EG000|Reported Event|68Ga-DOTATOC PET/CT|Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
11308688|NCT03136367|BG000|Baseline|Arm 1: Option Grid|"Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format."
11308689|NCT03136367|BG001|Baseline|Arm 2: Picture Option Grid|"Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy."
11308690|NCT03136367|BG002|Baseline|Arm 3: Usual Care|In the usual care arm, surgeons provided their standard information about breast cancer
11308691|NCT03136367|BG003|Baseline|Total|Total of all reporting groups
11308692|NCT03136367|FG000|Participant Flow|Arm 1: Option Grid|"Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format."
11308693|NCT03136367|FG001|Participant Flow|Arm 2: Picture Option Grid|"Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy."
11308694|NCT03136367|FG002|Participant Flow|Arm 3: Usual Care|In the usual care arm, surgeons provided their standard information about breast cancer.
11308695|NCT03136367|OG000|Outcome|Arm 1: Option Grid|"Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format."
11308696|NCT03136367|OG001|Outcome|Arm 2: Picture Option Grid|"Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy."
11308697|NCT03136367|OG002|Outcome|Arm 3: Usual Care|In the usual care arm, surgeons provided their standard information about breast cancer.
11308698|NCT03136367|OG002|Outcome|Arm 3: Usual Care|In the usual care arm, surgeons provided their standard information about breast cancer
11308699|NCT03136367|OG000|Outcome|Patients in Intervention Arms|Patients in this group received either the Option Grid or Picture Option Grid as a part of their care. Only patients in the intervention arms were interviewed for this outcome measure.
11308700|NCT03136367|OG001|Outcome|Surgeons Involved in the Trial|This group included all surgeons who participated in the trial. All surgeons were interviewed for this outcome measure.
11308701|NCT03136367|EG000|Reported Event|Arm 1: Option Grid|"Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format."
11308702|NCT03136367|EG001|Reported Event|Arm 2: Picture Option Grid|"Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.~Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy."
11308703|NCT03136367|EG002|Reported Event|Arm 3: Usual Care|In the usual care arm, surgeons provided their standard information about breast cancer.
11308704|NCT03136380|BG000|Baseline|Part 1-Total Participants|Participants received a single dose of GSK1325756H 10 mg (fed), GSK1325756 50 mg (fed), GSK1325756 100 mg (fed) and matching placebo in one of the three treatment periods in a crossover manner. The treatment periods were separated by a minimum of one-week washout period. The maximum duration of participation of participants, in Part 1 was 24 days.
11308705|NCT03136380|BG001|Baseline|Part 2-Total Participants|Participants received a single dose of GSK1325756 50 mg (fed) and GSK1325756 50 mg (fasted) in one of the two treatment periods in a crossover manner. The treatment periods were separated by a minimum of one-week washout period. The maximum duration of participation of participants, in Part 2 was 13 days.
11308706|NCT03136380|BG002|Baseline|Total|Total of all reporting groups
11308707|NCT03136380|FG000|Participant Flow|Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo|Participants in this arm received GSK1325756H 10 milligrams (mg) in treatment period 1 followed by GSK1325756H 50 mg in treatment period 2 followed by placebo in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period.
11308708|NCT03136380|FG001|Participant Flow|Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg|Participants in this arm received GSK1325756H 10 mg in treatment period 1 followed placebo in treatment period 2 followed by GSK1325756H 100 mg in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period.
11308709|NCT03136380|FG002|Participant Flow|Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg|Participants in this arm received placebo in treatment period 1 followed by GSK1325756H 50 mg in treatment period 2 followed by GSK1325756H 100 mg in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period.
11308710|NCT03136380|FG003|Participant Flow|Part 2-GSK1325756H Fed Followed by Fasted|Participants were randomized to receive GSK1325756H 50 mg (fed) in Period 1 followed by GSK1325756H (fasted) in Period 2 of Part 2. The treatment periods were separated were separated by a minimum of one-week washout period.
11308711|NCT03136380|FG004|Participant Flow|Part 2-GSK1325756H Fasted Followed by Fed|Participants were randomized to receive GSK1325756H 50 mg (fasted) in Period 1 followed by GSK1325756H (fed) in Period 2 of Part 2. The treatment periods were separated were separated by a minimum of one-week washout period.
11308712|NCT03136380|OG000|Outcome|Part 1: Placebo (Fed)|Participants received matching placebo tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308713|NCT03136380|OG001|Outcome|Part 1: GSK1325756H 10 mg (Fed)|Participants received GSK1325756H 10 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308714|NCT03136380|OG002|Outcome|Part 1: GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308715|NCT03136380|OG003|Outcome|Part 1: GSK1325756H 100 mg (Fed)|Participants received GSK1325756H 100 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308716|NCT03136380|OG000|Outcome|Part 2: GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 2.
11308717|NCT03136380|OG001|Outcome|Part 2: GSK1325756H 50 mg (Fasted)|Participants received GSK1325756H 50 mg tablets via the oral route without food (fasted state) and 240 milliliters of water in Part 2.
11308718|NCT03136380|OG000|Outcome|Part 1: GSK1325756H 10 mg (Fed)|Participants received GSK1325756H 10 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308719|NCT03136380|OG001|Outcome|Part 1: GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308720|NCT03136380|OG002|Outcome|Part 1: GSK1325756H 100 mg (Fed)|Participants received GSK1325756H 100 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308721|NCT03136380|OG001|Outcome|Part 1:GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308722|NCT03136380|EG000|Reported Event|Part 1: Placebo (Fed)|Participants received matching placebo tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308723|NCT03136380|EG001|Reported Event|Part 1: GSK1325756H 10 mg (Fed)|Participants received GSK1325756H 10 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308724|NCT03136380|EG002|Reported Event|Part 1: GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308725|NCT03136380|EG003|Reported Event|Part 1: GSK1325756H 100 mg (Fed)|Participants received GSK1325756H 100 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1.
11308726|NCT03136380|EG004|Reported Event|Part 2: GSK1325756H 50 mg (Fed)|Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 2.
11308727|NCT03136380|EG005|Reported Event|Part 2: GSK1325756H 50 mg (Fasted)|Participants received GSK1325756H 50 mg tablets via the oral route without food (fasted state) and 240 mililiters of water in Part 2.
11308728|NCT03136484|BG000|Baseline|Semaglutide + Canagliflozin Placebo|Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks.
11308729|NCT03136484|BG001|Baseline|Canagliflozin + Semaglutide Placebo|Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks.
11308730|NCT03136484|BG002|Baseline|Total|Total of all reporting groups
11308731|NCT03136484|FG000|Participant Flow|Semaglutide + Canagliflozin Placebo|Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks.
11308732|NCT03136484|FG001|Participant Flow|Canagliflozin + Semaglutide Placebo|Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks.
11308733|NCT03136484|OG000|Outcome|Semaglutide + Canagliflozin Placebo|Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks.
11308734|NCT03136484|OG001|Outcome|Canagliflozin + Semaglutide Placebo|Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks.
11308735|NCT03136484|EG000|Reported Event|Semaglutide + Canagliflozin Placebo|Participants received s.c. injection of semaglutide once-weekly for 52 weeks: 0.25 milligrams (mg) during 0-4 weeks followed by 0.5 mg during 5-8 weeks and then 1.0 mg during 9-52 weeks. Participants also received placebo matched to canagliflozin tablet once-daily for 52 weeks.
11308736|NCT03136484|EG001|Reported Event|Canagliflozin + Semaglutide Placebo|Participants received canagliflozin tablet once-daily orally for 52 weeks: 100 mg tablet during 0-8 weeks followed by 300 mg tablet during 9-52 weeks. Participants also received placebo matched to semaglutide s.c. injection once-weekly for 52 weeks.
11308737|NCT03136861|BG000|Baseline|Secukinumab 150 mg (Group A)|Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
11308738|NCT03136861|BG001|Baseline|Placebo (Group B)|Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
11308739|NCT03136861|BG002|Baseline|Arm A1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308740|NCT03136861|BG003|Baseline|Arm A2|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308741|NCT03136861|BG004|Baseline|Arm A3|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308742|NCT03136861|BG005|Baseline|Arm B1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308743|NCT03136861|BG006|Baseline|Arm B2|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308744|NCT03136861|BG007|Baseline|Total|Total of all reporting groups
11308745|NCT03136861|FG000|Participant Flow|Secukinumab 150 mg (Group A)|Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
11308746|NCT03136861|FG001|Participant Flow|Placebo (Group B)|Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
11308747|NCT03136861|FG002|Participant Flow|Arm A1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308748|NCT03136861|FG003|Participant Flow|Arm A2|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308749|NCT03136861|FG004|Participant Flow|Arm A3|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308750|NCT03136861|FG005|Participant Flow|Arm B1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308751|NCT03136861|FG006|Participant Flow|Arm B2|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308752|NCT03136861|OG000|Outcome|Secukinumab 150 mg (Group A)|Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
11308753|NCT03136861|OG001|Outcome|Placebo (Group B)|Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
11308754|NCT03136861|EG000|Reported Event|Secukinumab 150 mg (Group A)|Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
11308755|NCT03136861|EG001|Reported Event|Placebo (Group B)|Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
11308756|NCT03136861|EG002|Reported Event|Arm A1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308757|NCT03136861|EG003|Reported Event|Arm A2|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308758|NCT03136861|EG004|Reported Event|Arm A3|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308759|NCT03136861|EG005|Reported Event|Arm B1|Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
11308760|NCT03136861|EG006|Reported Event|Arm B2|Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
11308761|NCT03136913|BG000|Baseline|All Study Participants (OFT vs CFT)|Open flap technique (OFT) with secondary wound closure (test group) Closed flap technique (CFT) with primary wound closure (control group).
11308762|NCT03136913|FG000|Participant Flow|All Study Participants (OFT vs CFT)|"Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group).~OFT with flaps in position for healing by secondary intention CFT with flaps in primary coverage"
11308763|NCT03136913|OG000|Outcome|OFT vs CFT|Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group).
11308764|NCT03136913|OG000|Outcome|Open Flap Technique|"Healing by secondary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in position for healing by secondary intention.~Cytoplast® TXT-200: Non-resorbable membrane~MinerOss® Cortical and Cancellous Chips (FDBA): Mixture of allograft mineralized cortical and cancellous chips~Open Flap Technique: After extraction, the socket wound is left open to heal by secondary intention"
11308765|NCT03136913|OG001|Outcome|Closed Flap Technique|"Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage.~Cytoplast® TXT-200: Non-resorbable membrane~MinerOss® Cortical and Cancellous Chips (FDBA): Mixture of allograft mineralized cortical and cancellous chips~Closed Flap Technique: After extraction, the socket wound is closed by primary closure"
11308766|NCT03136913|EG000|Reported Event|Open Flap Technique (OFT)|Open flap technique (OFT, test group) with secondary wound closure
11308767|NCT03136913|EG001|Reported Event|Closed Flap Technique (CFT)|closed flap technique (CFT, control group) with primary wound closure
11308768|NCT03137069|BG000|Baseline|Cohort 1: Placebo|Participants received matching placebo twice daily from Day 1 to 56.
11308769|NCT03137069|BG001|Baseline|Cohort 1: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308770|NCT03137069|BG002|Baseline|Cohort 2: Placebo|Participants received matching placebo up to twice daily from Day 1 to 56.
11308771|NCT03137069|BG003|Baseline|Cohort 2: GDC-0853 50mg QD|Participants received GDC-0853 50mg once daily from Day 1 to 56.
11308772|NCT03137069|BG004|Baseline|Cohort 2: GDC-0853 150mg QD|Participants received GDC-0853 150mg once daily from Day 1 to 56.
11308773|NCT03137069|BG005|Baseline|Cohort 2: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308774|NCT03137069|BG006|Baseline|Total|Total of all reporting groups
11308775|NCT03137069|FG000|Participant Flow|Cohort 1: Placebo|Participants received matching placebo twice daily from Day 1 to 56.
11308776|NCT03137069|FG001|Participant Flow|Cohort 1: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308777|NCT03137069|FG002|Participant Flow|Cohort 2: Placebo|Participants received matching placebo up to twice daily from Day 1 to 56.
11308778|NCT03137069|FG003|Participant Flow|Cohort 2: GDC-0853 50mg QD|Participants received GDC-0853 50mg once daily from Day 1 to 56.
11308779|NCT03137069|FG004|Participant Flow|Cohort 2: GDC-0853 150mg QD|Participants received GDC-0853 150mg once daily from Day 1 to 56.
11308780|NCT03137069|FG005|Participant Flow|Cohort 2: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308781|NCT03137069|OG000|Outcome|Cohort 1: Placebo|Participants received matching placebo twice daily from Day 1 to 56.
11308782|NCT03137069|OG001|Outcome|Cohort 1: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308783|NCT03137069|OG002|Outcome|Cohort 2: Placebo|Participants received matching placebo up to twice daily from Day 1 to 56.
11308784|NCT03137069|OG003|Outcome|Cohort 2: GDC-0853 50mg QD|Participants received GDC-0853 50mg once daily from Day 1 to 56.
11308785|NCT03137069|OG004|Outcome|Cohort 2: GDC-0853 150mg QD|Participants received GDC-0853 150mg once daily from Day 1 to 56.
11308786|NCT03137069|OG005|Outcome|Cohort 2: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308787|NCT03137069|OG000|Outcome|Cohort 1: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308788|NCT03137069|OG001|Outcome|Cohort 2: GDC-0853 50mg QD|Participants received GDC-0853 50mg once daily from Day 1 to 56.
11308789|NCT03137069|OG002|Outcome|Cohort 2: GDC-0853 150mg QD|Participants received GDC-0853 150mg once daily from Day 1 to 56.
11308790|NCT03137069|OG003|Outcome|Cohort 2: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308791|NCT03137069|EG000|Reported Event|Cohort 1: Placebo|Participants received matching placebo twice daily from Day 1 to 56.
11308792|NCT03137069|EG001|Reported Event|Cohort 1: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308793|NCT03137069|EG002|Reported Event|Cohort 2: Placebo|Participants received matching placebo up to twice daily from Day 1 to 56.
11308794|NCT03137069|EG003|Reported Event|Cohort 2: GDC-0853 50mg QD|Participants received GDC-0853 50mg once daily from Day 1 to 56.
11308795|NCT03137069|EG004|Reported Event|Cohort 2: GDC-0853 150mg QD|Participants received GDC-0853 150mg once daily from Day 1 to 56.
11308796|NCT03137069|EG005|Reported Event|Cohort 2: GDC-0853 200mg BID|Participants received GDC-0853 200mg twice daily from Day 1 to 56.
11308797|NCT03137121|BG000|Baseline|Olanzapine|"Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.~Olanzapine: Olanzapine is used as an anti-emetic."
11308798|NCT03137121|BG001|Baseline|Placebo|"Patients will receive a placebo orally for 1 to 7 days daily.~Placebo: The placebo is a non-anti-emetic."
11308799|NCT03137121|BG002|Baseline|Total|Total of all reporting groups
11308800|NCT03137121|FG000|Participant Flow|Olanzapine|"Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.~Olanzapine: Olanzapine is used as an anti-emetic."
11308801|NCT03137121|FG001|Participant Flow|Placebo|"Patients will receive a placebo orally for 1 to 7 days daily.~Placebo: The placebo is a non-anti-emetic."
11308802|NCT03137121|OG000|Outcome|Olanzapine|"Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.~Olanzapine: Olanzapine is used as an anti-emetic."
11308803|NCT03137121|OG001|Outcome|Placebo|"Patients will receive a placebo orally for 1 to 7 days daily.~Placebo: The placebo is a non-anti-emetic."
11308804|NCT03137121|EG000|Reported Event|Olanzapine|"Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.~Olanzapine: Olanzapine is used as an anti-emetic."
11308805|NCT03137121|EG001|Reported Event|Placebo|"Patients will receive a placebo orally for 1 to 7 days daily.~Placebo: The placebo is a non-anti-emetic."
11308806|NCT03137303|BG000|Baseline|Patient Subject Usual Care|Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
11308807|NCT03137303|BG001|Baseline|Patient-Subject Intervention|Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
11308808|NCT03137303|BG002|Baseline|Total|Total of all reporting groups
11308809|NCT03137303|FG000|Participant Flow|Patient Subject Usual Care|Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
11308810|NCT03137303|FG001|Participant Flow|Patient-Subject Intervention|Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
11308811|NCT03137303|OG000|Outcome|Patient Subject Usual Care|Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
11308812|NCT03137303|OG001|Outcome|Patient-Subject Intervention|Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
11308813|NCT03137303|EG000|Reported Event|Patient Subject Usual Care|Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
11308814|NCT03137303|EG001|Reported Event|Patient-Subject Intervention|Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
11308815|NCT03137459|BG000|Baseline|STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report|"Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.~Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps."
11308816|NCT03137459|BG001|Baseline|Usual Care|"Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.~Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention."
11308817|NCT03137459|BG002|Baseline|Total|Total of all reporting groups
11308818|NCT03137459|FG000|Participant Flow|STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report|"Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.~Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps."
11308819|NCT03137459|FG001|Participant Flow|Usual Care|"Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.~Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention."
11308820|NCT03137459|OG000|Outcome|STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report|"Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.~Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps."
11308821|NCT03137459|OG001|Outcome|Usual Care|"Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.~Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention."
11308822|NCT03137459|OG000|Outcome|STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report|"Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.~Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps."
11333096|NCT03508687|OG000|Outcome|Group 1: 300 mg Gemcabene Daily Week 12-24|"After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene"
11308823|NCT03137459|EG000|Reported Event|STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report|"Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.~Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps."
11308824|NCT03137459|EG001|Reported Event|Usual Care|"Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.~Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention."
11308825|NCT03137784|BG000|Baseline|All Participants|All participants randomized to one of six treatment sequences
11308826|NCT03137784|FG000|Participant Flow|1(NVA237 50 ug/NVA237 25 ug/Placebo)|Treatment sequence: NVA 237 50 ug, 25 ug and placebo
11308827|NCT03137784|FG001|Participant Flow|2(NVA237 50 ug/Placebo/NVA237 25 ug)|Treatment sequence: NVA 237 50 ug, placebo and 25 ug
11308828|NCT03137784|FG002|Participant Flow|3 (NVA237 25 ug/NVA237 50 ug/Placebo)|Treatment sequence: NVA237 25 ug, 50 ug and placebo
11308829|NCT03137784|FG003|Participant Flow|4 (NVA237 25 ug/Placebo/NVA237 50 ug)|Treatment sequence: NVA 237 25 ug, placebo and 50 ug
11308830|NCT03137784|FG004|Participant Flow|5 (Placebo/NVA237 50 ug/ NVA237 25 ug)|Treatment sequence: Placebo, NVA237 50 ug and 25 ug
11308831|NCT03137784|FG005|Participant Flow|6 (Placebo/ NVA237 25 ug/NVA237 50 ug)|Treatment sequence: placebo, NVA237 25 ug and 50 ug
11308832|NCT03137784|OG000|Outcome|NVA237 50 ug|NVA237 50 g capsule
11308833|NCT03137784|OG001|Outcome|NVA237 25 ug|NVA237 25 μg capsule
11308834|NCT03137784|OG002|Outcome|Placebo|Placebo
11308835|NCT03137784|EG000|Reported Event|NVA237 50 ug|NVA237 50 ug capsule
11308836|NCT03137784|EG001|Reported Event|NVA237 25 ug|NVA237 25 ug capsule
11308837|NCT03137784|EG002|Reported Event|Placebo|Placebo
11308838|NCT03137992|BG000|Baseline|Safety Population|The safety analysis population included all patients who received at least one dose of any one of the randomized investigational products and for whom data had been collected after randomization. Patient baseline characteristics are not designated by treatment arms due to the crossover design of the study (treatment groups are not mutually exclusive).
11308839|NCT03137992|FG000|Participant Flow|Sequence A (T-R-P)|Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Spiriva Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Placebo in period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308840|NCT03137992|FG001|Participant Flow|Sequence B (R-P-T)|Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by placebo in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308841|NCT03137992|FG002|Participant Flow|Sequence C (P-T-R)|Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308842|NCT03137992|FG003|Participant Flow|Sequence D (P-R-T)|Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308843|NCT03137992|FG004|Participant Flow|Sequence E (T-P-R)|Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Placebo in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308844|NCT03137992|FG005|Participant Flow|Sequence F (R-T-P)|Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by Placebo in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days
11308845|NCT03137992|OG000|Outcome|Test Product (Tiotropium Bromide Inhalation Powder)|"Single dose 18 mcg of test product (tiotropium bromide inhalation powder), a long acting muscarinic receptor antagonist, for double blind portion.~Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness)."
11308846|NCT03137992|OG001|Outcome|Reference Product (Spiriva®)|"Single dose of reference product (Spiriva®) 18 mcg~Reference Product (Spiriva®): Reference product (Spiriva®) 18 mcg."
11308847|NCT03137992|OG002|Outcome|Placebo|"Single dose of placebo inhalation powder~Placebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers."
11308848|NCT03137992|EG000|Reported Event|Test Product (Lupin Tiotropium Bromide Inhalation Powder)|"Single dose 18 mcg of test product (tiotropium bromide inhalation powder) for double blind portion.~Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness)."
11308849|NCT03137992|EG001|Reported Event|Reference Product (Spiriva®)|"Single dose of reference product (Spiriva®) 18 mcg~Reference Product (Spiriva®): Reference product (Spiriva®) 18 mcg."
11308850|NCT03137992|EG002|Reported Event|Placebo|"Single dose of placebo inhalation powder~Placebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers."
11308851|NCT03138330|BG000|Baseline|FFQ Group|The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
11308852|NCT03138330|FG000|Participant Flow|FFQ Group|Ninety-one parents of Singaporean toddlers completed the sqFFQ and a 2-day weighed food record as the reference method.
11308853|NCT03138330|OG000|Outcome|FFQ Group|The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
11308854|NCT03138330|EG000|Reported Event|FFQ Group|The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
11308855|NCT03138382|BG000|Baseline|Active Then Sham|"20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308856|NCT03138382|BG001|Baseline|Sham Then Active|"20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308857|NCT03138382|BG002|Baseline|Total|Total of all reporting groups
11308858|NCT03138382|FG000|Participant Flow|Treatment Then Sham|"20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308859|NCT03138382|FG001|Participant Flow|Sham Then Treatment|"20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308860|NCT03138382|OG000|Outcome|Sham|"20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308861|NCT03138382|OG001|Outcome|Active|"20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308862|NCT03138382|EG000|Reported Event|Treatment Then Sham|"20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308863|NCT03138382|EG001|Reported Event|Sham Then Treatment|"20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry.~Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement.~Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves."
11308864|NCT03138577|BG000|Baseline|5 mL|5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308865|NCT03138577|BG001|Baseline|10 mL|10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308866|NCT03138577|BG002|Baseline|15 mL|15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308867|NCT03138577|BG003|Baseline|20 mL|20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308868|NCT03138577|BG004|Baseline|25 mL|25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308869|NCT03138577|BG005|Baseline|30 mL|30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308870|NCT03138577|BG006|Baseline|35 mL|35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308871|NCT03138577|BG007|Baseline|Total|Total of all reporting groups
10972081|NCT00919191|BG000|Baseline|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
10972082|NCT00919191|FG000|Participant Flow|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
10972083|NCT00919191|OG000|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split face model
10972084|NCT00919191|OG001|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
10972085|NCT00919191|OG000|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split-face model
10972086|NCT00919191|EG000|Reported Event|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
10972087|NCT00919503|BG000|Baseline|Regimen A (PBSCT and BMT)|"CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1.~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~Allogeneic Bone Marrow Transplantation: Infused IV~Anti-Thymocyte Globulin: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Peripheral Blood Stem Cell Transplantation: Infused IV~Tacrolimus: Given IV or PO~Treosulfan: Given IV"
11308872|NCT03138577|FG000|Participant Flow|Dose Cohort 7|Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308873|NCT03138577|FG001|Participant Flow|Dose Cohort 6|Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308874|NCT03138577|FG002|Participant Flow|Dose Cohort 5|Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308875|NCT03138577|FG003|Participant Flow|Dose Cohort 4|Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308876|NCT03138577|FG004|Participant Flow|Dose Cohort 3|Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308877|NCT03138577|FG005|Participant Flow|Dose Cohort 2|Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308878|NCT03138577|FG006|Participant Flow|Dose Cohort 1|Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308879|NCT03138577|OG000|Outcome|Dose Cohort 7 (5 mL)|Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308880|NCT03138577|OG001|Outcome|Dose Cohort 6 (10 mL)|Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308881|NCT03138577|OG002|Outcome|Dose Cohort 5 (15 mL)|Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308882|NCT03138577|OG003|Outcome|Dose Cohort 4 (20 mL)|Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308883|NCT03138577|OG004|Outcome|Dose Cohort 3 (25 mL)|Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308884|NCT03138577|OG005|Outcome|Dose Cohort 2 (30 mL)|Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308885|NCT03138577|OG006|Outcome|Dose Cohort 1 (35 mL)|Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308886|NCT03138577|OG000|Outcome|Subjects With HDP|All subjects, regardless of local anesthetic dose, that demonstrated HDP 30 minutes after block placement.
11308887|NCT03138577|OG001|Outcome|Subjects Without HDP|All subjects, regardless of local anesthetic dose, that did not demonstrate HDP 30 minutes after block placement.
11308888|NCT03138577|EG000|Reported Event|Dose Cohort 7 (5 mL)|Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308889|NCT03138577|EG001|Reported Event|Dose Cohort 6 (10 mL)|Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308890|NCT03138577|EG002|Reported Event|Dose Cohort 5 (15 mL)|Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308891|NCT03138577|EG003|Reported Event|Dose Cohort 4 (20 mL)|Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308892|NCT03138577|EG004|Reported Event|Dose Cohort 3 (25 mL)|Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308893|NCT03138577|EG005|Reported Event|Dose Cohort 2 (30 mL)|Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308894|NCT03138577|EG006|Reported Event|Dose Cohort 1 (35 mL)|Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
11308895|NCT03138655|BG000|Baseline|UC: <30 kg Participants, Vedolizumab 100 mg|Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308896|NCT03138655|BG001|Baseline|UC: <30 kg Participants, Vedolizumab 200 mg|Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308897|NCT03138655|BG002|Baseline|CD: <30 kg Participants, Vedolizumab 100 mg|Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308898|NCT03138655|BG003|Baseline|CD: <30 kg Participants, Vedolizumab 200 mg|Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308899|NCT03138655|BG004|Baseline|UC: >=30 kg Participants, Vedolizumab 150 mg|Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308900|NCT03138655|BG005|Baseline|UC: >=30 kg Participants, Vedolizumab 300 mg|Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308901|NCT03138655|BG006|Baseline|CD: >=30 kg Participants, Vedolizumab 150 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308902|NCT03138655|BG007|Baseline|CD: >=30 kg Participants, Vedolizumab 300 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308903|NCT03138655|BG008|Baseline|Total|Total of all reporting groups
11308904|NCT03138655|FG000|Participant Flow|UC: <30 kg Participants, Vedolizumab 100 mg|Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308905|NCT03138655|FG001|Participant Flow|UC: <30 kg Participants, Vedolizumab 200 mg|Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308906|NCT03138655|FG002|Participant Flow|CD: <30 kg Participants, Vedolizumab 100 mg|Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308907|NCT03138655|FG003|Participant Flow|CD: <30 kg Participants, Vedolizumab 200 mg|Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308908|NCT03138655|FG004|Participant Flow|UC: >=30 kg Participants, Vedolizumab 150 mg|Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308909|NCT03138655|FG005|Participant Flow|UC: >=30 kg Participants, Vedolizumab 300 mg|Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308910|NCT03138655|FG006|Participant Flow|CD: >=30 kg Participants, Vedolizumab 150 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308911|NCT03138655|FG007|Participant Flow|CD: >=30 kg Participants, Vedolizumab 300 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308912|NCT03138655|OG000|Outcome|UC: <30 kg Participants, Vedolizumab 100 mg|Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308913|NCT03138655|OG001|Outcome|UC: <30 kg Participants, Vedolizumab 200 mg|Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308914|NCT03138655|OG002|Outcome|CD: <30 kg Participants, Vedolizumab 100 mg|Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308915|NCT03138655|OG003|Outcome|CD: <30 kg Participants, Vedolizumab 200 mg|Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308916|NCT03138655|OG004|Outcome|UC: >=30 kg Participants, Vedolizumab 150 mg|Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308917|NCT03138655|OG005|Outcome|UC: >=30 kg Participants, Vedolizumab 300 mg|Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308918|NCT03138655|OG006|Outcome|CD: >=30 kg Participants, Vedolizumab 150 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308919|NCT03138655|OG007|Outcome|CD: >=30 kg Participants, Vedolizumab 300 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308920|NCT03138655|OG002|Outcome|UC: >=30 kg Participants, Vedolizumab 150 mg|Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308921|NCT03138655|OG003|Outcome|UC: >=30 kg Participants, Vedolizumab 300 mg|Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308922|NCT03138655|OG000|Outcome|CD: <30 kg Participants, Vedolizumab 100 mg|Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308923|NCT03138655|OG001|Outcome|CD: <30 kg Participants, Vedolizumab 200 mg|Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308924|NCT03138655|OG002|Outcome|CD: >=30 kg Participants, Vedolizumab 150 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308925|NCT03138655|OG003|Outcome|CD: >=30 kg Participants, Vedolizumab 300 mg|Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308926|NCT03138655|EG000|Reported Event|<30 kg Participants, Vedolizumab 100 mg|Participants with UC or CD having baseline weight of <30 kg, were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308927|NCT03138655|EG001|Reported Event|<30 kg Participants, Vedolizumab 200 mg|Participants with UC or CD having baseline weight of <30 kg, were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308928|NCT03138655|EG002|Reported Event|<30 kg Participants, Vedolizumab 100 mg to 200 mg|Participants from '<30 kg Participants, Vedolizumab 100 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 200 mg IV infusion at Week 14.
11308929|NCT03138655|EG003|Reported Event|>=30 kg Participants, Vedolizumab 150 mg|Participants with UC or CD having baseline weight of >=30 kg, were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308930|NCT03138655|EG004|Reported Event|>=30 kg Participants, Vedolizumab 300 mg|Participants with UC or CD having baseline weight of >=30 kg, were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
11308931|NCT03138655|EG005|Reported Event|>=30 kg Participants, Vedolizumab 150 mg to 300 mg|Participants from '>=30 kg Participants, Vedolizumab 150 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 300 mg IV infusion at Week 14.
11308932|NCT03138798|BG000|Baseline|Laboraide TM Dental Support Device|Laboraide TM dental support device
11308933|NCT03138798|BG001|Baseline|Control Group|No device
11308934|NCT03138798|BG002|Baseline|Total|Total of all reporting groups
11308935|NCT03138798|FG000|Participant Flow|Laboraide TM Dental Support Device|Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the dental support device (DSD) while pushing.
11308936|NCT03138798|FG001|Participant Flow|Control Group|no device
11308937|NCT03138798|OG000|Outcome|Laboraide TM Dental Support Device|Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
11308938|NCT03138798|OG001|Outcome|Control Group|No device
11308939|NCT03138798|OG000|Outcome|Laboraide TM Support Device|Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
11308940|NCT03138798|EG000|Reported Event|Laboraide TM Dental Support Device|Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing.
11308941|NCT03138798|EG001|Reported Event|Control Group|No device
11308942|NCT03138876|BG000|Baseline|EEG Cap|Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.
11308943|NCT03138876|FG000|Participant Flow|EEG Cap|Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear Non-convulsive status epilepticus (NCSE) is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.
11308944|NCT03138876|OG000|Outcome|EEG Cap|Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.
11308945|NCT03138876|EG000|Reported Event|EEG Cap|Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.
11308946|NCT03138967|BG000|Baseline|Suggamadex or Treatment Group|Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
11308947|NCT03138967|BG001|Baseline|Neostigime/Glycopyrrolate or Standard of Care Group|Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
11308948|NCT03138967|BG002|Baseline|Total|Total of all reporting groups
11308949|NCT03138967|FG000|Participant Flow|Suggamadex or Treatment Group|Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
11308950|NCT03138967|FG001|Participant Flow|Neostigime/Glycopyrrolate or Standard of Care Group|Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
11308951|NCT03138967|OG000|Outcome|Suggamadex or Treatment Group|Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
11308952|NCT03138967|OG001|Outcome|Neostigime/Glycopyrrolate or Standard of Care Group|Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
11308953|NCT03138967|EG000|Reported Event|Suggamadex or Treatment Group|Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
11308954|NCT03138967|EG001|Reported Event|Neostigime/Glycopyrrolate or Standard of Care Group|Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
11308955|NCT03139032|BG000|Baseline|Etrasimod|Participants received active treatment for 12 weeks.
11308956|NCT03139032|FG000|Participant Flow|Etrasimod|Participants received active treatment for 12 weeks.
11308957|NCT03139032|OG000|Outcome|Etrasimod|Participants received active treatment for 12 weeks.
11308958|NCT03139032|OG000|Outcome|Etrasimod|Participants received one active treatment for 12 weeks.
11308959|NCT03139032|EG000|Reported Event|Etrasimod|Participants received active treatment for 12 weeks.
11308960|NCT03139240|BG000|Baseline|Oxycodone: <7 Weeks Gestational Age|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks randomized to oxycodone 10mg oral"
11308961|NCT03139240|BG001|Baseline|Placebo: <7 Weeks Gestational Age|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks randomized to placebo"
11308962|NCT03139240|BG002|Baseline|Oxycodone: 7-10w0d Weeks Gestational Age|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral"
11308963|NCT03139240|BG003|Baseline|Placebo: 7-10w0d Weeks Gestational Age|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age 7-10w0d randomized to placebo"
11308964|NCT03139240|BG004|Baseline|Total|Total of all reporting groups
11308965|NCT03139240|FG000|Participant Flow|Oxycodone: <7 Weeks of Gestation|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks randomized to oxycodone 10mg oral"
11308966|NCT03139240|FG001|Participant Flow|Placebo: <7 Weeks Gestational Age|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo"
11308967|NCT03139240|FG002|Participant Flow|Oxycodone: 7-10w0d Gestational Age|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral"
11308968|NCT03139240|FG003|Participant Flow|Placebo: 7-10w0d Gestational Age|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo"
11308969|NCT03139240|OG000|Outcome|Oxycodone Arm|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral"
11308970|NCT03139240|OG001|Outcome|Placebo Arm|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo"
11308971|NCT03139240|OG000|Outcome|Oxycodone|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks randomized to oxycodone 10mg oral"
11308972|NCT03139240|OG001|Outcome|Placebo|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks randomized to placebo"
11308973|NCT03139240|EG000|Reported Event|Oxycodone|"Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral"
11308974|NCT03139240|EG001|Reported Event|Placebo|"Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion~Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to placebo"
11308975|NCT03139279|BG000|Baseline|Dexmedetomidine and Propofol|"Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus~Propofol: Propofol titrated intravenous boluses"
11308976|NCT03139279|BG001|Baseline|Saline Placebo and Propofol|"Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Saline placebo: Intravenous saline/placebo~Propofol: Propofol titrated intravenous boluses"
11308977|NCT03139279|BG002|Baseline|Total|Total of all reporting groups
11308978|NCT03139279|FG000|Participant Flow|Dexmedetomidine and Propofol|"Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus~Propofol: Propofol titrated intravenous boluses"
11308979|NCT03139279|FG001|Participant Flow|Saline Placebo and Propofol|"Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Saline placebo: Intravenous saline/placebo~Propofol: Propofol titrated intravenous boluses"
11308980|NCT03139279|OG000|Outcome|Dexmedetomidine and Propofol|"Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus~Propofol: Propofol titrated intravenous boluses"
11308981|NCT03139279|OG001|Outcome|Saline Placebo and Propofol|"Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Saline placebo: Intravenous saline/placebo~Propofol: Propofol titrated intravenous boluses"
11308982|NCT03139279|EG000|Reported Event|Dexmedetomidine and Propofol|"Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus~Propofol: Propofol titrated intravenous boluses"
11308983|NCT03139279|EG001|Reported Event|Saline Placebo and Propofol|"Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.~Saline placebo: Intravenous saline/placebo~Propofol: Propofol titrated intravenous boluses"
11308984|NCT03139448|BG000|Baseline|Oxygen Via Nasal Cannula (Standard of Care)|"The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.~Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center."
11308985|NCT03139448|BG001|Baseline|Oxygen Via SuperNO2VA Nasal Mask|"The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.~Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O."
11308986|NCT03139448|BG002|Baseline|Total|Total of all reporting groups
11308987|NCT03139448|FG000|Participant Flow|Oxygen Via Nasal Cannula (Standard of Care)|"The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.~Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center."
11308988|NCT03139448|FG001|Participant Flow|Oxygen Via SuperNO2VA Nasal Mask|"The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.~Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O."
11308989|NCT03139448|OG000|Outcome|Oxygen Via Nasal Cannula (Standard of Care)|"The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.~Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center."
11308990|NCT03139448|OG001|Outcome|Oxygen Via SuperNO2VA Nasal Mask|"The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.~Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O."
11308991|NCT03139448|EG000|Reported Event|Oxygen Via Nasal Cannula (Standard of Care)|"The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.~Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center."
11308992|NCT03139448|EG001|Reported Event|Oxygen Via SuperNO2VA Nasal Mask|"The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.~Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O."
11308993|NCT03139552|BG000|Baseline|Taste Testers|"150 subjects were enrolled to taste three recipes of apple crisp, tea and oatmeal. Subjects were asked to paricitpate in tastings of all three items.Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS): Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Taste testings ofeach test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted all three recipes of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week)."
11308994|NCT03139552|FG000|Participant Flow|Taste Testers|"150 subjects were enrolled to participate in three taste test sessions of apple crisp, tea and oatmeal. At each session, three recipes of each item were tasted. Each subject was randomly assigned to one of six possible sequences to taste the three recipes. The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS): Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of each item in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted all three recipes of an item at one sitting."
11308995|NCT03139552|OG000|Outcome|Full Sugar Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of each item in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11308996|NCT03139552|OG001|Outcome|Reduced Sugar Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of each item in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11308997|NCT03139552|OG002|Outcome|Reduced Sugar Plus Spice Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of each item in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11308998|NCT03139552|OG000|Outcome|First Place Ranking|Number of subjects who rated this recipe in first place (most likable)
11308999|NCT03139552|OG001|Outcome|Second Place Ranking|Number of subjects who rated this recipe in second place
11309000|NCT03139552|OG002|Outcome|Third Place Ranking|Number of subjects who rated this recipe in third place (least likable)
11309001|NCT03139552|EG000|Reported Event|Full Sugar Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Apple Crisp: Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11309002|NCT03139552|EG001|Reported Event|Reduced Sugar Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Apple Crisp: Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11333097|NCT03508687|OG001|Outcome|Group 2: 600mg Gemcabene Daily Week 12-24|"After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene"
11309003|NCT03139552|EG002|Reported Event|Reduced Sugar Plus Spice Recipe|"Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):~Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A~Apple Crisp: Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting."
11309004|NCT03139578|BG000|Baseline|Total|All subjects who were administered any test article excluding subjects who drop out prior to administering any test article
11309005|NCT03139578|FG000|Participant Flow|C 8.5\C 9.0\T 8.5\T 9.0|Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
11309006|NCT03139578|FG001|Participant Flow|C 9.0\C 8.5\T 9.0\T 8.5|Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
11309007|NCT03139578|FG002|Participant Flow|T 8.5\T 9.0\C 8.5\C 9.0|Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
11309008|NCT03139578|FG003|Participant Flow|T 9.0\T 8.5\C 9.0\C 8.5|Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
11309009|NCT03139578|OG000|Outcome|Test 8.5BC|Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309010|NCT03139578|OG001|Outcome|Test 9.0BC|Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309011|NCT03139578|OG002|Outcome|Control 8.5BC|Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309012|NCT03139578|OG003|Outcome|Control 9.0BC|Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309013|NCT03139578|EG000|Reported Event|Test 8.5BC|Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309014|NCT03139578|EG001|Reported Event|Test 9.0BC|Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309015|NCT03139578|EG002|Reported Event|Control 8.5BC|Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309016|NCT03139578|EG003|Reported Event|Control 9.0BC|Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
11309017|NCT03139604|BG000|Baseline|Itacitinib Plus Corticosteroids|Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309018|NCT03139604|BG001|Baseline|Placebo Plus Corticosteroids|Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309019|NCT03139604|BG002|Baseline|Total|Total of all reporting groups
11309020|NCT03139604|FG000|Participant Flow|Itacitinib Plus Corticosteroids|Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309021|NCT03139604|FG001|Participant Flow|Placebo Plus Corticosteroids|Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309022|NCT03139604|OG000|Outcome|Itacitinib Plus Corticosteroids|Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309023|NCT03139604|OG001|Outcome|Placebo Plus Corticosteroids|Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309024|NCT03139604|EG000|Reported Event|Itacitinib Plus Corticosteroids|Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309025|NCT03139604|EG001|Reported Event|Placebo Plus Corticosteroids|Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
11309026|NCT03139604|EG002|Reported Event|Total|Total
11309027|NCT03140254|BG000|Baseline|Treated Participants|Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
11309028|NCT03140254|FG000|Participant Flow|Treated Participants|Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
11309029|NCT03140254|OG000|Outcome|Investigational Product|"Investigational Product (IP) BDIP-0001~N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride"
11309030|NCT03140254|OG001|Outcome|Active Control|Active Control (AC) Sage 2% Chlorhexidine gluconate
11309031|NCT03140254|OG002|Outcome|Vehicle Control|Vehicle Control (VC)
11309032|NCT03140254|EG000|Reported Event|All Participants|Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
11309033|NCT03140631|BG000|Baseline|Control|Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
11309034|NCT03140631|BG001|Baseline|Protamine|"Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs. ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.~Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects."
11309035|NCT03140631|BG002|Baseline|Total|Total of all reporting groups
11309036|NCT03140631|FG000|Participant Flow|Control|Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of activated clotting time (ACT) beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
11309037|NCT03140631|FG001|Participant Flow|Protamine|"Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs. Activated clotting time (ACT) levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.~Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects."
11309038|NCT03140631|OG000|Outcome|Control|Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
11309039|NCT03140631|OG001|Outcome|Protamine|"Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs. ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.~Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects."
11309040|NCT03140631|OG001|Outcome|Protamine|"Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.~Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects."
11309041|NCT03140631|EG000|Reported Event|Control|Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
11309042|NCT03140631|EG001|Reported Event|Protamine|"Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs. ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.~Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects."
11309043|NCT03140722|BG000|Baseline|Vadadustat|Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
11309044|NCT03140722|BG001|Baseline|Epoetin Alfa|Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
11309045|NCT03140722|BG002|Baseline|Total|Total of all reporting groups
11309046|NCT03140722|FG000|Participant Flow|Vadadustat|Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
11309047|NCT03140722|FG001|Participant Flow|Epoetin Alfa|Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
11309048|NCT03140722|OG000|Outcome|Vadadustat|Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
11309049|NCT03140722|OG001|Outcome|Epoetin Alfa|Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
11309050|NCT03140722|EG000|Reported Event|Vadadustat|Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL).
11309051|NCT03140722|EG001|Reported Event|Epoetin Alfa|Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study.
11309052|NCT03141086|BG000|Baseline|Group 1: LML134, Then Placebo|LML134, then placebo
11309053|NCT03141086|BG001|Baseline|Group 2: Placebo, Then LML134|Placebo, then LML134
11309054|NCT03141086|BG002|Baseline|Total|Total of all reporting groups
11309055|NCT03141086|FG000|Participant Flow|Group 1: LML134, Then Placebo|LML134, then placebo
11309056|NCT03141086|FG001|Participant Flow|Group 2: Placebo, Then LML134|Placebo, then LML134
11309057|NCT03141086|OG000|Outcome|LML134 5mg|LML134 5mg
11309058|NCT03141086|OG001|Outcome|Placebo|Placebo
11309059|NCT03141086|EG000|Reported Event|LML134 5mg|LML134 5mg
11309060|NCT03141086|EG001|Reported Event|Placebo|Placebo
11309061|NCT03141151|BG000|Baseline|COACH: Healthy Bodies|"This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.~COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family."
11309062|NCT03141151|BG001|Baseline|COACH: Strong Minds|"This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.~COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills"
11309063|NCT03141151|BG002|Baseline|Total|Total of all reporting groups
11309064|NCT03141151|FG000|Participant Flow|COACH: Healthy Bodies|"This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.~COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family."
11309065|NCT03141151|FG001|Participant Flow|COACH: Strong Minds|"This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.~COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills"
11309066|NCT03141151|OG000|Outcome|COACH: Healthy Bodies|"This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.~COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family."
11309067|NCT03141151|OG001|Outcome|COACH: Strong Minds|"This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.~COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills"
11309068|NCT03141151|EG000|Reported Event|COACH: Healthy Bodies|"This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.~COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family."
11309069|NCT03141151|EG001|Reported Event|COACH: Strong Minds|"This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.~COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills"
11309070|NCT03141242|BG000|Baseline|ENACT Group Visit|"Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.~ENACT group visit: Participation in two 2 hour group visits about advance care planning."
11309071|NCT03141242|BG001|Baseline|Mailed Resources|"Participants will receive printed advance care planning resources by mail.~Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider."
11309072|NCT03141242|BG002|Baseline|Total|Total of all reporting groups
11309073|NCT03141242|FG000|Participant Flow|ENACT Group Visit|"Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.~ENACT group visit: Participation in two 2 hour group visits about advance care planning."
11309074|NCT03141242|FG001|Participant Flow|Mailed Resources|"Participants will receive printed advance care planning resources by mail.~Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider."
11309075|NCT03141242|OG000|Outcome|ENACT Group Visit|"Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.~ENACT group visit: Participation in two 2 hour group visits about advance care planning."
11309076|NCT03141242|OG001|Outcome|Mailed Resources|"Participants will receive printed advance care planning resources by mail.~Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider."
11309077|NCT03141242|OG000|Outcome|Study Recruitment Rate|Participants will provide informed consent to participate in a randomized controlled trial of a two 2-hour group visit intervention related to advance care planning, including printed advance care planning resources (ENACT intervention arm) or a mailed advance care planning materials (mailed control arm)
11309078|NCT03141242|EG000|Reported Event|ENACT Group Visit|"Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.~ENACT group visit: Participation in two 2 hour group visits about advance care planning."
11309079|NCT03141242|EG001|Reported Event|Mailed Resources|"Participants will receive printed advance care planning resources by mail.~Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider."
11309080|NCT03141281|BG000|Baseline|BrainHQ|"Participants will be provided with a laptop computer and enrolled in a commercial web-based cognitive training program, BrainHQ, trained on how to access it, and instructed to complete a fixed number of sessions in 20 hours.~BrainHQ: BrainHQ"
11309081|NCT03141281|BG001|Baseline|Rise of Nations|"Participants will be provided with a laptop computer with the Rise of Nations video game, be trained in game play, and instructed to play the game for 20 hours~Rise of Nations: Rise of Nations"
11309082|NCT03141281|BG002|Baseline|IADL Training|"Participants will be enrolled in AARP's web-based driver training course, trained on how to access it, and asked to complete the course, estimated to take approximately 6-8 hours. They will also be provided with web-based access to a finance and fraud avoidance training tutorial, instructed on how to access it, and be asked to complete the course, estimated to take approximately 5-7 hours. The two courses combined are estimated to take about 15 hours.~IADL Training: IADL Training"
11309083|NCT03141281|BG003|Baseline|Active Control|"Participants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search~Active Control: Puzzle solving"
11309084|NCT03141281|BG004|Baseline|Total|Total of all reporting groups
11309085|NCT03141281|FG000|Participant Flow|BrainHQ|"Participants will be provided with a laptop computer and enrolled in a commercial web-based cognitive training program, BrainHQ, trained on how to access it, and instructed to complete a fixed number of sessions in 20 hours.~BrainHQ: BrainHQ"
11309086|NCT03141281|FG001|Participant Flow|Rise of Nations|"Participants will be provided with a laptop computer with the Rise of Nations video game, be trained in game play, and instructed to play the game for 20 hours~Rise of Nations: Rise of Nations"
11309087|NCT03141281|FG002|Participant Flow|IADL Training|"Training in instrumental activities of daily living. Participants will be enrolled in American Association of Retired Persons' web-based driver training course, trained on how to access it, and asked to complete the course, estimated to take approximately 6-8 hours. They will also be provided with web-based access to a finance and fraud avoidance training tutorial, instructed on how to access it, and be asked to complete the course, estimated to take approximately 5-7 hours. The two courses combined are estimated to take about 15 hours.~IADL Training: IADL Training"
11309088|NCT03141281|FG003|Participant Flow|Active Control|"Participants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search~Active Control: Puzzle solving"
11309089|NCT03141281|OG000|Outcome|BrainHQ|"Participants will be provided with a laptop computer and enrolled in a commercial web-based cognitive training program, BrainHQ, trained on how to access it, and instructed to complete a fixed number of sessions in 20 hours.~BrainHQ: BrainHQ"
11309090|NCT03141281|OG001|Outcome|Rise of Nations|"Participants will be provided with a laptop computer with the Rise of Nations video game, be trained in game play, and instructed to play the game for 20 hours~Rise of Nations: Rise of Nations"
11309091|NCT03141281|OG002|Outcome|IADL Training|"Participants will be enrolled in AARP's web-based driver training course, trained on how to access it, and asked to complete the course, estimated to take approximately 6-8 hours. They will also be provided with web-based access to a finance and fraud avoidance training tutorial, instructed on how to access it, and be asked to complete the course, estimated to take approximately 5-7 hours. The two courses combined are estimated to take about 15 hours.~IADL Training: IADL Training"
11309092|NCT03141281|OG003|Outcome|Active Control|"Participants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search~Active Control: Puzzle solving"
11309093|NCT03141281|EG000|Reported Event|BrainHQ|"Participants will be provided with a laptop computer and enrolled in a commercial web-based cognitive training program, BrainHQ, trained on how to access it, and instructed to complete a fixed number of sessions in 20 hours.~BrainHQ: BrainHQ"
11309094|NCT03141281|EG001|Reported Event|Rise of Nations|"Participants will be provided with a laptop computer with the Rise of Nations video game, be trained in game play, and instructed to play the game for 20 hours~Rise of Nations: Rise of Nations"
11309095|NCT03141281|EG002|Reported Event|IADL Training|"Participants will be enrolled in AARP's web-based driver training course, trained on how to access it, and asked to complete the course, estimated to take approximately 6-8 hours. They will also be provided with web-based access to a finance and fraud avoidance training tutorial, instructed on how to access it, and be asked to complete the course, estimated to take approximately 5-7 hours. The two courses combined are estimated to take about 15 hours.~IADL Training: IADL Training"
11309096|NCT03141281|EG003|Reported Event|Active Control|"Participants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search~Active Control: Puzzle solving"
11309097|NCT03141307|BG000|Baseline|Intervention|"The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.~EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.~EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app."
11309098|NCT03141307|BG001|Baseline|Control|"This group will receive the standard of care currently used (paper-based brochure)~Control: Standard of care, paper-based brochure"
11309099|NCT03141307|BG002|Baseline|Total|Total of all reporting groups
11309100|NCT03141307|FG000|Participant Flow|Intervention|"The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.~EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.~EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app."
11309101|NCT03141307|FG001|Participant Flow|Control|"This group will receive the standard of care currently used (paper-based brochure)~Control: Standard of care, paper-based brochure"
11309102|NCT03141307|OG000|Outcome|Intervention|"The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.~EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.~EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app."
11309103|NCT03141307|OG001|Outcome|Control|"This group will receive the standard of care currently used (paper-based brochure)~Control: Standard of care, paper-based brochure"
11309104|NCT03141307|EG000|Reported Event|Intervention|"The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.~EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.~EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app."
11309105|NCT03141307|EG001|Reported Event|Control|"This group will receive the standard of care currently used (paper-based brochure)~Control: Standard of care, paper-based brochure"
11309106|NCT03141372|BG000|Baseline|Autofill Void Trial|"Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309107|NCT03141372|BG001|Baseline|Backfill Void Trial|"About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL or if the patient is unable to void within the hour, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309108|NCT03141372|BG002|Baseline|Total|Total of all reporting groups
11333098|NCT03508687|EG000|Reported Event|Group 1: 300 mg Gemcabene Daily Week 1-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene"
11333099|NCT03508687|EG001|Reported Event|Group 2: 600mg Gemcabene Daily Week 12-24|"Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene"
11309109|NCT03141372|FG000|Participant Flow|Autofill Void Trial|"Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309110|NCT03141372|FG001|Participant Flow|Backfill Void Trial|"About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL or if the patient is unable to void within the hour, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309111|NCT03141372|OG000|Outcome|Autofill Void Trial|"Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309112|NCT03141372|OG001|Outcome|Backfill Void Trial|"About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309113|NCT03141372|OG000|Outcome|Autofill Void Trial|"Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309114|NCT03141372|OG001|Outcome|Backfill Void Trial|"About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL or if the patient is unable to void within the hour, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309115|NCT03141372|EG000|Reported Event|Autofill Void Trial|"Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11333100|NCT03508830|BG000|Baseline|Liposomal Bupivacaine|Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11333101|NCT03508830|BG001|Baseline|Standard Bupivacaine|Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11333102|NCT03508830|BG002|Baseline|Total|Total of all reporting groups
11333103|NCT03508830|FG000|Participant Flow|Liposomal Bupivacaine|Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11333104|NCT03508830|FG001|Participant Flow|Standard Bupivacaine|Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11309116|NCT03141372|EG001|Reported Event|Backfill Void Trial|"About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL or if the patient is unable to void within the hour, the void trial will be considered failed and a Foley catheter will be replaced.~Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured."
11309117|NCT03141528|BG000|Baseline|Instructor-led Learning|"This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)~Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)"
11309118|NCT03141528|BG001|Baseline|Self-learning|"This group will Train alone without supervision and without communicating with the other participants.~Self-learning: Training without supervision"
11309119|NCT03141528|BG002|Baseline|Total|Total of all reporting groups
11309120|NCT03141528|FG000|Participant Flow|Instructor-led Learning|"This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)~Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)"
11309121|NCT03141528|FG001|Participant Flow|Self-learning|"This group will Train alone without supervision and without communicating with the other participants.~Self-learning: Training without supervision"
11309122|NCT03141528|OG000|Outcome|Instructor-led Learning|"This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)~Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)"
11309123|NCT03141528|OG001|Outcome|Self-learning|"This group will Train alone without supervision and without communicating with the other participants.~Self-learning: Training without supervision"
11309124|NCT03141528|EG000|Reported Event|Instructor-led Learning|"This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)~Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)"
11309125|NCT03141528|EG001|Reported Event|Self-learning|"This group will Train alone without supervision and without communicating with the other participants.~Self-learning: Training without supervision"
11309126|NCT03141788|BG000|Baseline|3M Clear Aligner|"Clear Aligner Treatment~Clear Aligner: Clear Aligner used to straighten teeth to desired outcome"
11309127|NCT03141788|FG000|Participant Flow|3M Clear Aligner|3M Clear Aligner for Orthodontic Treatment
11309128|NCT03141788|OG000|Outcome|3M Clear Aligner|Clear Aligner Orthodontic Treatment for malocclusion
11309129|NCT03141788|OG000|Outcome|3M Clear Aligner|Clear Aligner Orthodontic Treatment
11309130|NCT03141788|OG000|Outcome|3M Clear Aligner|"Clear Aligner for Orthodontic Treatment~Clear Aligner: Clear Aligner used to straighten teeth to desired outcome"
11309131|NCT03141788|OG000|Outcome|3M Clear Aligner|3M Clear Aligner for Orthodontic Treatment
11309132|NCT03141788|EG000|Reported Event|3M Clear Aligner|3M Clear Aligner for Orthodontic Treatment
11309133|NCT03141905|BG000|Baseline|Sick-Day Protocol|Sick-Day Protocol: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
11309134|NCT03141905|BG001|Baseline|Usual Care|Usual Care: Standard clinical care
11309135|NCT03141905|BG002|Baseline|Total|Total of all reporting groups
11309136|NCT03141905|FG000|Participant Flow|Sick-Day Protocol|Sick-Day Protocol: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
11309137|NCT03141905|FG001|Participant Flow|Usual Care|Usual Care: Standard clinical care
11309138|NCT03141905|OG000|Outcome|Sick-Day Protocol|Sick-Day Protocol: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
11309139|NCT03141905|OG001|Outcome|Usual Care|Usual Care: Standard clinical care
11309140|NCT03141905|OG000|Outcome|Sick-Day Protocol|Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
11309141|NCT03141905|EG000|Reported Event|Sick-Day Protocol|Sick-Day Protocol: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
11309142|NCT03141905|EG001|Reported Event|Usual Care|Usual Care: Standard clinical care
11309143|NCT03141931|BG000|Baseline|Supplement|"Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids~Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg"
11309144|NCT03141931|BG001|Baseline|Placebo|"Polyethylene glycol, Oleic acid, Propylene glycol~Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)"
11309145|NCT03141931|BG002|Baseline|Total|Total of all reporting groups
11309146|NCT03141931|FG000|Participant Flow|Lacritec|"Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids~Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg"
11309147|NCT03141931|FG001|Participant Flow|Placebo|"Polyethylene glycol, Oleic acid, Propylene glycol~Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)"
11309148|NCT03141931|OG000|Outcome|Lacritec|"Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids~Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg"
11309149|NCT03141931|OG001|Outcome|Placebo|"Polyethylene glycol, Oleic acid, Propylene glycol~Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)"
11309150|NCT03141931|EG000|Reported Event|Lacritec|"Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids~Lacritec: Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg"
11309151|NCT03141931|EG001|Reported Event|Placebo|"Polyethylene glycol, Oleic acid, Propylene glycol~Placebo: polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)"
11309152|NCT03142438|BG000|Baseline|F&P Seal Improvement Project|"participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm~F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm."
11309153|NCT03142438|FG000|Participant Flow|F&P Seal Improvement Project|"participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm~F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm."
11309154|NCT03142438|OG000|Outcome|F&P Seal Improvement Project|"participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm~F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm."
11309155|NCT03142438|EG000|Reported Event|F&P Seal Improvement Project|F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
11309156|NCT03142451|BG000|Baseline|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
11309157|NCT03142451|BG001|Baseline|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
11309158|NCT03142451|BG002|Baseline|Total|Total of all reporting groups
11309159|NCT03142451|FG000|Participant Flow|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
11309160|NCT03142451|FG001|Participant Flow|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
11309161|NCT03142451|OG000|Outcome|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
11309162|NCT03142451|OG001|Outcome|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
11309163|NCT03142451|EG000|Reported Event|FMX103 1.5%|Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
11309164|NCT03142451|EG001|Reported Event|Vehicle Foam|Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
11309165|NCT03142750|BG000|Baseline|Foam and Saddle Gastrostomy Tube Dressing|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children"
11309166|NCT03142750|BG001|Baseline|Third Gastrostomy Tube Dressing Prototype|A third prototype gastronomy tube dressing will be created using the feedback collected from the first group of subjects about the Saddle and Foam dressings. A new group of participants will receive the prototype dressing.
11309167|NCT03142750|BG002|Baseline|Total|Total of all reporting groups
11309168|NCT03142750|FG000|Participant Flow|Experimental: Saddle and Foam Gastronomy Tube Dressing|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children"
11309169|NCT03142750|FG001|Participant Flow|Experimental: Gastronomy Tube Dressing Prototype|A third prototype gastronomy tube dressing will be created using the feedback collected from the first group of subjects about the Saddle and Foam dressings. A new group of participants will receive the prototype dressing.
11309170|NCT03142750|OG000|Outcome|Foam Gastronomy Tube Dressing|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children"
11309171|NCT03142750|OG001|Outcome|Saddle Gastrostomy Tube Dressing|This group was given a 1 week supply of both the saddle and foam type gastrostomy tube dressing for trial at home.
11309172|NCT03142750|OG002|Outcome|Third Prototype|Third prototype (silicone pod and flexible snap rings)
11309173|NCT03142750|OG000|Outcome|Foam Gastrostomy Tube Dressing|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children"
11309174|NCT03142750|OG001|Outcome|Saddle Design Gastrostomy Dressing|The intervention includes providing a one week supply of each of the two gastrostomy tube dressings to ten participants to try at home.
11309175|NCT03142750|EG000|Reported Event|Foam Gastrostomy Dressing Prototype|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children~Only 10 participants completed follow up"
11309176|NCT03142750|EG001|Reported Event|Saddle Gastrostomy Dressing Prototype|"The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.~Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children~Only 10 participants completed follow up"
11309177|NCT03142750|EG002|Reported Event|Third Gastrostomy Dressing Prototype|"Using feedback from the Foam and Saddle groups a third Gastrostomy Dressing Prototype was created and trialed by a new group of participants~Only 9 participants completed follow up"
11309178|NCT03142932|BG000|Baseline|Control|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309179|NCT03142932|BG001|Baseline|COach2Quit|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.~Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.~Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)~COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309180|NCT03142932|BG002|Baseline|Total|Total of all reporting groups
11309181|NCT03142932|FG000|Participant Flow|Control|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309182|NCT03142932|FG001|Participant Flow|COach2Quit|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.~Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.~Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)~COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309183|NCT03142932|OG000|Outcome|Control|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309184|NCT03142932|OG001|Outcome|COach2Quit|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.~Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.~Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)~COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309185|NCT03142932|EG000|Reported Event|Control|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309186|NCT03142932|EG001|Reported Event|COach2Quit|"A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.~Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.~Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)~COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor~Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."
11309187|NCT03143101|BG000|Baseline|FluMist Trivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
11309188|NCT03143101|BG001|Baseline|FluMist Quadrivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309189|NCT03143101|BG002|Baseline|FluMist Quadrivalent (2017-2018)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309190|NCT03143101|BG003|Baseline|Total|Total of all reporting groups
11309191|NCT03143101|FG000|Participant Flow|FluMist Trivalent (2015-2016)|Participants received intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
11309192|NCT03143101|FG001|Participant Flow|FluMist Quadrivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309193|NCT03143101|FG002|Participant Flow|FluMist Quadrivalent (2017-2018)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309194|NCT03143101|OG000|Outcome|FluMist Trivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
11309195|NCT03143101|OG001|Outcome|FluMist Quadrivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309196|NCT03143101|OG002|Outcome|FluMist Quadrivalent (2017-2018)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309197|NCT03143101|EG000|Reported Event|FluMist Trivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
11309198|NCT03143101|EG001|Reported Event|FluMist Quadrivalent (2015-2016)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309199|NCT03143101|EG002|Reported Event|FluMist Quadrivalent (2017-2018)|Participants received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
11309200|NCT03143166|BG000|Baseline|Total Subjects|Subjects were treated orally with dabigatran etexilate 110 mg tablet alone (Reference) after an overnight fast of at least 10 hours (h) without pretreatment with rabeprazole 20 mg tablet in period 1 followed by single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets (Test) once daily with 4 days of rabeprazole pre-treatment in period 2. The treatments of dabigatran etexilate were separated by a wash-out phase of at least 4 days.
11309201|NCT03143166|FG000|Participant Flow|Dabigatran Etexilate 110 mg With and Without Rabeprazole 20 mg|Subjects were treated orally with dabigatran etexilate 110 mg tablet alone (Reference) after an overnight fast of at least 10 hours (h) without pretreatment with rabeprazole 20 mg tablet in period 1 followed by single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets (Test) once daily with 4 days of rabeprazole pre-treatment in period 2. The treatments of dabigatran etexilate were separated by a wash-out phase of at least 4 days.
11309202|NCT03143166|OG000|Outcome|Dabigatran Etexilate 110 mg (Reference)|Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
11309203|NCT03143166|OG001|Outcome|Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)|Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
11309204|NCT03143166|EG000|Reported Event|Dabigatran Etexilate 110 mg (Reference)|Subjects were treated orally with dabigatran etexilate 110 mg tablet alone after an overnight fast of at least 10 hours (h) without pre-treatment with rabeprazole 20 mg tablet.
11333105|NCT03508830|OG000|Outcome|Liposomal Bupivacaine|Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11309205|NCT03143166|EG001|Reported Event|Dabigatran Etexilate 110 mg + Rabeprazole 20 mg (Test)|Subjects were treated orally with single dose of dabigatran etexilate 110 mg tablet and rabeprazole 20 mg tablets once daily with 4 days of rabeprazole pre-treatment.
11309206|NCT03143569|BG000|Baseline|aPTT Nomogram|"aPTT guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309207|NCT03143569|BG001|Baseline|Anti-factor Xa Nomogram|"Anti-factor Xa guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309208|NCT03143569|BG002|Baseline|Total|Total of all reporting groups
11309209|NCT03143569|FG000|Participant Flow|aPTT Nomogram|"aPTT guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309210|NCT03143569|FG001|Participant Flow|Anti-factor Xa Nomogram|"Anti-factor Xa guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309211|NCT03143569|OG000|Outcome|aPTT Nomogram|"aPTT guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device."
11309212|NCT03143569|OG001|Outcome|Anti-factor Xa Nomogram|"Anti-factor Xa guided heparin management~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309213|NCT03143569|OG000|Outcome|aPTT Nomogram|"aPTT guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309214|NCT03143569|OG001|Outcome|Anti-factor Xa Nomogram|"Anti-factor Xa guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309215|NCT03143569|EG000|Reported Event|aPTT Nomogram|"aPTT guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309216|NCT03143569|EG001|Reported Event|Anti-factor Xa Nomogram|"Anti-factor Xa guided heparin management~aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.~Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device"
11309217|NCT03143855|BG000|Baseline|Lorcaserin|Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
11309218|NCT03143855|BG001|Baseline|Control Group|Placebo: Placebo will be administered twice daily for for 5 days
11309219|NCT03143855|BG002|Baseline|Total|Total of all reporting groups
11309220|NCT03143855|FG000|Participant Flow|Lorcaserin|Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
11309221|NCT03143855|FG001|Participant Flow|Control Group|Placebo: Placebo will be administered twice daily for for 5 days
11309222|NCT03143855|OG000|Outcome|Lorcaserin|Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
11309223|NCT03143855|OG001|Outcome|Control Group|Placebo: Placebo will be administered twice daily for for 5 days
11309224|NCT03143855|EG000|Reported Event|Lorcaserin|Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
11309225|NCT03143855|EG001|Reported Event|Control Group|Placebo: Placebo will be administered twice daily for for 5 days
11309226|NCT03143894|BG000|Baseline|Active tDCS First|"2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS).."
11309227|NCT03143894|BG001|Baseline|Sham tDCS First|"Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS).."
11309228|NCT03143894|BG002|Baseline|Total|Total of all reporting groups
11309229|NCT03143894|FG000|Participant Flow|Active tDCS First|"2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11309230|NCT03143894|FG001|Participant Flow|Sham tDCS First|"Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11333106|NCT03508830|OG001|Outcome|Standard Bupivacaine|Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11309231|NCT03143894|OG000|Outcome|Active tDCS|"2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11309232|NCT03143894|OG001|Outcome|Sham tDCS|"Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11309233|NCT03143894|OG000|Outcome|Active tDCS (5 Days)|"2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11309234|NCT03143894|OG001|Outcome|Sham tDCS (5 Days)|"Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.~Sham tDCS: Sham Transcranial direct current stimulation (tDCS)."
11309235|NCT03143894|EG000|Reported Event|Active tDCS|"2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes."
11309236|NCT03143894|EG001|Reported Event|Sham tDCS|"Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.~tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes."
11309237|NCT03144089|BG000|Baseline|Guedel Oral Airway Placed First|"This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309238|NCT03144089|BG001|Baseline|Articulated Oral Airway Placed First|"This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309239|NCT03144089|BG002|Baseline|Total|Total of all reporting groups
11309240|NCT03144089|FG000|Participant Flow|Guedel Oral Airway Placed First|"This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309241|NCT03144089|FG001|Participant Flow|Articulated Oral Airway Placed First|"This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309242|NCT03144089|OG000|Outcome|Guedel Oral Airway|"This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309243|NCT03144089|OG001|Outcome|Articulated Oral Airway|"This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309244|NCT03144089|OG000|Outcome|Guedel Oral Airway Placed First|"This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11333107|NCT03508830|EG000|Reported Event|Liposomal Bupivacaine|Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11333108|NCT03508830|EG001|Reported Event|Standard Bupivacaine|Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
11309245|NCT03144089|OG001|Outcome|Articulated Oral Airway Placed First|"This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309246|NCT03144089|EG000|Reported Event|Guedel Oral Airway|"This group is randomized to receive the Guedel oral airway first and data recorded. The airway was removed and followed by insertion of the Articulated Oral Airway second and data recorded.~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309247|NCT03144089|EG001|Reported Event|Articulated Oral Airway|"This group is randomized to receive the Articulated Oral Airway first and data recorded. The airway was removed and followed by insertion the Guedel oral airway second and data recorded.~Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.~Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation."
11309248|NCT03144180|BG000|Baseline|Control|The Q-cup will not be used to collect umbilical cord blood.
11309249|NCT03144180|BG001|Baseline|Study Group|"The Q-cup will be used to collect umbilical cord blood.~Q-cup: This technology is a different way of collecting umbilical cord blood."
11309250|NCT03144180|BG002|Baseline|Total|Total of all reporting groups
11309251|NCT03144180|FG000|Participant Flow|Control|The standard of care methods of umbilical cord collection was used. These include: 1) milking the blood from the umbilical cord into an open specimen tube 2) holding the umbilical cord over a basin and letting blood drip into it, then drawing up the blood into a needless syringe 3) Holding the umbilical cord over a specimen tube and letting the blood drip into it 4) using a conventional needle and syringe to draw blood directly from the cord.
11309252|NCT03144180|FG001|Participant Flow|Study Group|Umbilical cord blood was collected using the Q-cup device.
11309253|NCT03144180|OG000|Outcome|Standard of Care (Control)|A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the standard methods.
11309254|NCT03144180|OG001|Outcome|Q Cup (Study)|A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the Q-cup device.
11309255|NCT03144180|OG000|Outcome|Standard of Care (Control)|The Q-cup will not be used to collect umbilical cord blood.
11309256|NCT03144180|OG001|Outcome|Q-cup (Study)|"The Q-cup will be used to collect umbilical cord blood.~Q-cup: This technology is a different way of collecting umbilical cord blood."
11309257|NCT03144180|EG000|Reported Event|Standard of Care (Control)|Participants were randomized into the standard of care group in which the Qcup was not used to collect umbilical cord blood by the delivery provider.
11309258|NCT03144180|EG001|Reported Event|Qcup (Study)|Participants were randomized into the study group in which the Qcup was used to collect umbilical cord blood by the delivery provider.
11309259|NCT03144518|BG000|Baseline|Experimental|"Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.~Positive Affect Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309260|NCT03144518|BG001|Baseline|Active Control|"Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.~Neutral Control Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309261|NCT03144518|BG002|Baseline|Total|Total of all reporting groups
11309262|NCT03144518|FG000|Participant Flow|Experimental|"Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.~Positive Affect Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309263|NCT03144518|FG001|Participant Flow|Active Control|"Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.~Neutral Control Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11333109|NCT03508843|BG000|Baseline|Interactive Virtual Presence|"install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence~interactive virtual presence: installing the car seat with advice via interactive virtual presence"
11333110|NCT03508843|FG000|Participant Flow|Interactive Virtual Presence|"install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence~interactive virtual presence: installing the car seat with advice via interactive virtual presence"
11309264|NCT03144518|OG000|Outcome|Experimental|"Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.~Positive Affect Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309265|NCT03144518|OG001|Outcome|Active Control|"Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.~Neutral Control Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309266|NCT03144518|OG000|Outcome|Whole Trial|Recruitment Details are presented for trial as a whole
11309267|NCT03144518|EG000|Reported Event|Experimental|"Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.~Positive Affect Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309268|NCT03144518|EG001|Reported Event|Active Control|"Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.~Neutral Control Intervention: See Previous Description~Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)"
11309269|NCT03144635|BG000|Baseline|Grazoprevir Plus Elbasvir|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309270|NCT03144635|FG000|Participant Flow|Grazoprevir Plus Elbasvir|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309271|NCT03144635|OG000|Outcome|Grazoprevir Plus Elbasvir|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309272|NCT03144635|OG000|Outcome|Intention-to-treat Populations|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309273|NCT03144635|OG001|Outcome|Per-protocol Populations|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309274|NCT03144635|EG000|Reported Event|Grazoprevir Plus Elbasvir|"Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.~Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks."
11309275|NCT03144804|BG000|Baseline|Lamivudine|"Lamivudine administered orally every 4 weeks~Treatment cycles will last 28 consecutive days~The dosage will be determine by the PI~Lamivudine: This drug may help prevent the growth and spread of the cancer cells to other parts of the body."
11309276|NCT03144804|FG000|Participant Flow|Lamivudine|"Lamivudine administered orally every 4 weeks~Treatment cycles will last 28 consecutive days~The dosage will be determine by the PI~Lamivudine: This drug may help prevent the growth and spread of the cancer cells to other parts of the body."
11309277|NCT03144804|OG000|Outcome|Lamivudine|"Lamivudine administered orally every 4 weeks~Treatment cycles will last 28 consecutive days~The dosage will be determine by the PI~Lamivudine: This drug may help prevent the growth and spread of the cancer cells to other parts of the body."
11309278|NCT03144804|EG000|Reported Event|Lamivudine|"Lamivudine administered orally every 4 weeks~Treatment cycles will last 28 consecutive days~The dosage will be determine by the PI~Lamivudine: This drug may help prevent the growth and spread of the cancer cells to other parts of the body."
11309279|NCT03145064|BG000|Baseline|Zanubrutinib|Participants received 160 mg of zanubrutinib BID.
11309280|NCT03145064|FG000|Participant Flow|Zanubrutinib|Participants received 160 milligrams (mg) of zanubrutinib twice daily (BID).
11309281|NCT03145064|OG000|Outcome|Zanubrutinib|Participants received 160 mg of zanubrutinib BID.
11309282|NCT03145064|OG000|Outcome|Zanubrutinib|Participants received 160 milligrams (mg) of zanubrutinib twice daily (BID).
11309283|NCT03145064|EG000|Reported Event|Zanubrutinib|Participants received 160 mg of zanubrutinib BID.
11309284|NCT03145207|BG000|Baseline|Lidocaine|Session 1-name brand patch Session 2-generic lidocaine patch Session 3-name brand patch with early heat application Session 4-name brand patch with late heat application Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
11309285|NCT03145207|FG000|Participant Flow|Lidocaine|"Session 1-name brand patch Session 2-generic lidocaine patch Session 3-name brand patch with early heat application Session 4-name brand patch with late heat application Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping~The same 12 volunteers completed each of the seven study sessions."
11309286|NCT03145207|OG000|Outcome|Lidocaine Name Brand Patch|Session 1-name brand patch
11309287|NCT03145207|OG001|Outcome|Lidocaine Generic Patch|Session 2-generic lidocaine patch
11309288|NCT03145207|OG002|Outcome|Lidocaine Name Brand Patch Early Heat|Session 3-name brand patch with early heat application
11309289|NCT03145207|OG003|Outcome|Lidocaine Name Brand Patch Late Heat|Session 4-name brand patch with late heat application
11309290|NCT03145207|OG004|Outcome|Lidocaine Generic Early Heat|Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
11309291|NCT03145207|OG005|Outcome|Lidocaine Generic Late Heat|Session 6-generic patch with late heat application
11309292|NCT03145207|EG000|Reported Event|Name Brand Patch|"name brand lidocaine patch~Lidocaine patch: lidocaine patch"
11309293|NCT03145207|EG001|Reported Event|Generic Patch|"generic lidocaine patch~Lidocaine patch: lidocaine patch"
11309294|NCT03145207|EG002|Reported Event|Name Brand Patch-early|"name brand lidocaine patch-early~Lidocaine patch: lidocaine patch"
11309295|NCT03145207|EG003|Reported Event|Name Brand Patch-late|"name brand lidocaine patch-late~Lidocaine patch: lidocaine patch"
11309296|NCT03145207|EG004|Reported Event|Generic Patch-early|"generic lidocaine patch-early~Lidocaine patch: lidocaine patch"
11309297|NCT03145207|EG005|Reported Event|Generic Patch-late|"generic lidocaine patch-late~Lidocaine patch: lidocaine patch"
11309298|NCT03145207|EG006|Reported Event|Both Patches|"brand name and generic lidocaine patch~Lidocaine patch: lidocaine patch"
11309299|NCT03145259|BG000|Baseline|Diclofenac|Study Session 1. diclofenac epolamine patch Study Session 2. diclofenac sodium solution Study Session 3. diclofenac epolamine patch pieces and diclofenac sodium solution
11309300|NCT03145259|FG000|Participant Flow|Diclofenac|Study Session 1. diclofenac epolamine patch Study Session 2. diclofenac sodium solution Study Session 3. diclofenac epolamine patch pieces and diclofenac sodium solution
11309301|NCT03145259|OG000|Outcome|Diclofenac Epolamine Patches|"diclofenac epolamine patches~Diclofenac Epolamine Patch: patch"
11309302|NCT03145259|OG001|Outcome|Diclofenac Sodium Solution|"diclofenac sodium solution~diclofenac sodium solution: solution"
11309303|NCT03145259|EG000|Reported Event|Diclofenac Epolamine Patches|"diclofenac epolamine patches~Diclofenac Epolamine Patch: patch"
11309304|NCT03145259|EG001|Reported Event|Diclofenac Sodium Solution|"diclofenac sodium solution~diclofenac sodium solution: solution"
11309305|NCT03145259|EG002|Reported Event|Diclofenac Epolamine Patches and Diclofenac Sodium Solution|"patch pieces and solution~Diclofenac Epolamine Patch: patch~diclofenac sodium solution: solution"
11309306|NCT03145818|BG000|Baseline|Veterans|"Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309307|NCT03145818|BG001|Baseline|Caregivers|"Caregivers support Veterans independence in their home and community~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309308|NCT03145818|BG002|Baseline|VHA Coordinators|"VHA VD-HCBS Coordinators allow the program to operate within the VA~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309309|NCT03145818|BG003|Baseline|ADNA Coordinators|"ADNA Coordinators engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309310|NCT03145818|BG004|Baseline|Total|Total of all reporting groups
11309311|NCT03145818|FG000|Participant Flow|Veterans|"Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired. The surveys are given at the onset of the program and quarterly and yearly thereafter.~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309312|NCT03145818|FG001|Participant Flow|Caregivers|"Caregivers support Veterans independence in their home and community~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309313|NCT03145818|FG002|Participant Flow|VHA Coordinators|"VHA VD-HCBS Coordinators allow the program to operate within the VA~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309314|NCT03145818|FG003|Participant Flow|ADNA Coordinators|"ADNA Coordinators engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309315|NCT03145818|OG000|Outcome|Veterans|"Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309316|NCT03145818|OG000|Outcome|Caregivers|"Caregivers supporting Veterans independence in their home and community~VD-HCBS: Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease"
11309317|NCT03145818|EG000|Reported Event|Veterans|Veterans enrolled in VD-HCBS have needs for services, the primary outcome are the needs which are not currently met
11309318|NCT03145818|EG001|Reported Event|Caregivers|Caregiving wellbeing will be measured with a composite of financial strain, depressive symptoms, caregiving stress, and health status and positive caregiver experiences.
11309319|NCT03145818|EG002|Reported Event|VA Coordinators|This semi-structured interview will identify constructs from the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change (ERIC).
11309320|NCT03145818|EG003|Reported Event|VHA Coordinators|This semi-structured interview will identify constructs from the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change (ERIC).
11309321|NCT03146403|BG000|Baseline|GEN-003|"60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection~GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D~Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol."
11309322|NCT03146403|BG001|Baseline|Placebo|"0.9% normal saline administered as a 0.5mL intramuscular (IM) injection~0.9% normal saline: Placebo"
11309323|NCT03146403|BG002|Baseline|Total|Total of all reporting groups
11309324|NCT03146403|FG000|Participant Flow|GEN-003|"60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection~GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D~Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol."
11309325|NCT03146403|FG001|Participant Flow|Placebo|"0.9% normal saline administered as a 0.5mL intramuscular (IM) injection~0.9% normal saline: Placebo"
11309326|NCT03146403|OG000|Outcome|GEN-003|"60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection~GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D~Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol."
11309327|NCT03146403|OG001|Outcome|Placebo|"0.9% normal saline administered as a 0.5mL intramuscular (IM) injection~0.9% normal saline: Placebo"
11309328|NCT03146403|EG000|Reported Event|GEN-003|"60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection~GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D~Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol."
11309329|NCT03146403|EG001|Reported Event|Placebo|"0.9% normal saline administered as a 0.5mL intramuscular (IM) injection~0.9% normal saline: Placebo"
11309330|NCT03146585|BG000|Baseline|Patients on Artificial Ventilation|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309331|NCT03146585|BG001|Baseline|Patients on Renal Replacement Therapy|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309332|NCT03146585|BG002|Baseline|Patients With Targeted Temperature Management|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309333|NCT03146585|BG003|Baseline|Total|Total of all reporting groups
11309334|NCT03146585|FG000|Participant Flow|Patients on Artificial Ventilation|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309335|NCT03146585|FG001|Participant Flow|Patients on Renal Replacement Therapy|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309336|NCT03146585|FG002|Participant Flow|Patients With Targeted Temperature Management|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309337|NCT03146585|OG000|Outcome|Patients on Artificial Ventilation|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309338|NCT03146585|OG001|Outcome|Patients on Renal Replacement Therapy|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309339|NCT03146585|OG002|Outcome|Patients With Targeted Temperature Management|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309340|NCT03146585|EG000|Reported Event|Patients on Artificial Ventilation|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309341|NCT03146585|EG001|Reported Event|Patients on Renal Replacement Therapy|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309342|NCT03146585|EG002|Reported Event|Patients With Targeted Temperature Management|PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
11309343|NCT03146663|BG000|Baseline|Arm A|NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309344|NCT03146663|BG001|Baseline|Arm B|NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309345|NCT03146663|BG002|Baseline|Total|Total of all reporting groups
11309346|NCT03146663|FG000|Participant Flow|Arm A|NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309347|NCT03146663|FG001|Participant Flow|Arm B|NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309348|NCT03146663|OG000|Outcome|Arm A|NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309349|NCT03146663|OG001|Outcome|Arm B|NUC-1031 750 mg/m2 administered on Days 1, 8 and 15, of 28-day cycles
11309350|NCT03146663|OG001|Outcome|Arm B|NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309351|NCT03146663|EG000|Reported Event|Arm A|NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309352|NCT03146663|EG001|Reported Event|Arm B|NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
11309353|NCT03146741|BG000|Baseline|Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
11309354|NCT03146741|FG000|Participant Flow|Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
11309355|NCT03146741|OG000|Outcome|Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
11309356|NCT03146741|EG000|Reported Event|Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)|"Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected - in this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.~Note: No subjects experienced treatment failure requiring sofosbuvir. Adverse events were collected the same way for all subjects in the setting of only 1 medication regimen intervention (Zepatier). For that reason we present the results and AEs in 1 arm containing all 10 subjects."
11309357|NCT03146806|BG000|Baseline|Intranasal Ketamine Treatment|Study participants receiving three different doses of intranasal ketamine and one dose of IV ketamine, at four different study visits, for treatment of cancer pain.
11309358|NCT03146806|FG000|Participant Flow|Ketamine Treatment|On the first study visit, 10mg of intranasal ketamine was given to make sure that the study patients could tolerate a small dose of intranasal ketamine. On the second visit, 10 mg of intravenous (IV) ketamine was given to compare the two routes of ketamine administration, with patients serving as their own controls. On the third and fourth visit, higher doses of intranasal ketamine, 30 mg and 50 mg respectively, were given, if the patients did not have severe adverse events with the smaller dosage. Participants returned for a fifth visit, 24 hours after Visit 4, to provide a blood sample and complete questionnaires.
11309359|NCT03146806|OG000|Outcome|10 mg Intranasal Ketamine|Study participants receiving 10 mg of intranasal ketamine.
11309360|NCT03146806|OG001|Outcome|10 mg Intravenous (IV) Ketamine|Study participants receiving 10 mg of ketamine intravenously.
11309361|NCT03146806|OG002|Outcome|30 mg Intranasal Ketamine|Study participants receiving 30 mg of intranasal ketamine.
11309362|NCT03146806|OG003|Outcome|50 mg Intranasal Ketamine|Study participants receiving 50 mg of intranasal ketamine.
11309363|NCT03146806|OG004|Outcome|Follow-up Visit|Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
11309364|NCT03146806|OG000|Outcome|Visit 1 (10 mg Intranasal Ketamine Administered)|Study participants receiving 10 mg of intranasal ketamine.
11309365|NCT03146806|OG001|Outcome|Follow-up Visit|Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
11309366|NCT03146806|OG000|Outcome|Intranasal Ketamine Treatment|Study participants receiving three different doses of intranasal ketamine and one dose of IV ketamine, at four different study visits, for treatment of cancer pain.
11309367|NCT03146806|EG000|Reported Event|10 mg Intranasal Ketamine|Study participants receiving 10 mg of intranasal ketamine.
11309368|NCT03146806|EG001|Reported Event|10 mg Intravenous (IV) Ketamine|Study participants receiving 10 mg of ketamine intravenously.
11309369|NCT03146806|EG002|Reported Event|30 mg Intranasal Ketamine|Study participants receiving 30 mg of intranasal ketamine.
11309370|NCT03146806|EG003|Reported Event|50 mg Intranasal Ketamine|Study participants receiving 50 mg of intranasal ketamine.
11309371|NCT03146806|EG004|Reported Event|Follow-up Visit|Participants returned for a fifth visit to complete questionnaires. No study medication was administered during this visit.
11309372|NCT03146806|EG005|Reported Event|Phone Call 14 Days Post-Last Dose|Participants were called 14 days after the last dose of study medication to assess adverse events.
11309373|NCT03147248|BG000|Baseline|Cohort 1: CT-P13 IV 3 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309374|NCT03147248|BG001|Baseline|Cohort 2: CT-P13 SC 90 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309375|NCT03147248|BG002|Baseline|Cohort 3: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309376|NCT03147248|BG003|Baseline|Cohort 4: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309377|NCT03147248|BG004|Baseline|Arm 1: CT-P13 SC 120 mg (Part 2)|"Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64.~Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose."
11309378|NCT03147248|BG005|Baseline|Arm 2: CT-P13 IV 3 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309379|NCT03147248|BG006|Baseline|Total|Total of all reporting groups
11309380|NCT03147248|FG000|Participant Flow|Cohort 1: CT-P13 IV 3 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309381|NCT03147248|FG001|Participant Flow|Cohort 2: CT-P13 SC 90 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309382|NCT03147248|FG002|Participant Flow|Cohort 3: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309383|NCT03147248|FG003|Participant Flow|Cohort 4: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309384|NCT03147248|FG004|Participant Flow|Arm 1: CT-P13 SC 120 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309385|NCT03147248|FG005|Participant Flow|Arm 2: CT-P13 IV 3 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309386|NCT03147248|OG000|Outcome|Cohort 1: CT-P13 IV 3 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309387|NCT03147248|OG001|Outcome|Cohort 2: CT-P13 SC 90 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309388|NCT03147248|OG002|Outcome|Cohort 3: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309389|NCT03147248|OG003|Outcome|Cohort 4: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309390|NCT03147248|OG000|Outcome|Arm 1: CT-P13 SC 120 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309391|NCT03147248|OG001|Outcome|Arm 2: CT-P13 IV 3 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309392|NCT03147248|EG000|Reported Event|Cohort 1: CT-P13 IV 3 mg/kg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 3 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. Throughout the study, methotrexate (MTX) 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309393|NCT03147248|EG001|Reported Event|Cohort 2: CT-P13 SC 90 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 90 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6. The dose of SC 90 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 2: CT-P13 SC 90 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309394|NCT03147248|EG002|Reported Event|Cohort 3: CT-P13 SC 120 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6 up to Week 54. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309395|NCT03147248|EG003|Reported Event|Cohort 4: CT-P13 SC 180 mg (Part 1)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) by SC injection via PFS with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 mg every 2 weeks after Week 30 in applicable patients in Cohort 4: CT-P13 SC 180 mg. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309396|NCT03147248|EG004|Reported Event|Arm 1: CT-P13 SC 120 mg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) by SC injection via pre-filled syringe (PFS) with a 2-week interval from Week 6 up to Week 54 with placebo IV at Weeks 6, 14, and 22. Patients in specific countries were administered CT-P13 SC via auto injector (AI) at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309397|NCT03147248|EG005|Reported Event|Arm 2: CT-P13 IV 3 mg/kg (Part 2)|Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 3 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22) with placebo SC at Week 6 and every 2 weeks thereafter up to Week 28. CT-P13 IV were switched to receive CT-P13 SC via PFS at Week 30, and further doses with CT-P13 SC were given up to Week 54. Patients in specific countries were administered CT-P13 SC via AI at Week 46 and every 2 weeks thereafter up to Week 54, and patients were switched back to CT-P13 SC via PFS at Week 56 and every 2 weeks thereafter up to Week 64. Throughout the study, MTX 12.5 to 25 mg/week (between 10 to 25 mg/week in Korea), oral and parenteral dose and folic acid (≥ 5 mg/week) were coadministered, oral dose.
11309398|NCT03147495|BG000|Baseline|the Study Group|"The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309399|NCT03147495|BG001|Baseline|the Control Group|"The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309400|NCT03147495|BG002|Baseline|Total|Total of all reporting groups
11309401|NCT03147495|FG000|Participant Flow|the Study Group|"The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309402|NCT03147495|FG001|Participant Flow|the Control Group|"The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309403|NCT03147495|OG000|Outcome|the Study Group|The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
11309404|NCT03147495|OG001|Outcome|the Control Group|The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
11309405|NCT03147495|EG000|Reported Event|the Study Group|"The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309406|NCT03147495|EG001|Reported Event|the Control Group|"The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.~no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups."
11309407|NCT03147690|BG000|Baseline|All Study Participants|"All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL~Lumason: Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL."
11309408|NCT03147690|FG000|Participant Flow|All Study Participants|"All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL~Lumason: Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL."
10848539|NCT00290342|BG001|Baseline|Infanrix + IMOVAX Polio Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
11309409|NCT03147690|OG000|Outcome|All Study Participants|"All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL~Lumason: Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL."
11309410|NCT03147690|OG000|Outcome|Liver|All subjects will have a liver injury identified by CT
11309411|NCT03147690|OG001|Outcome|Spleen|All subjects will have a spleen injury identified by CT
11309412|NCT03147690|OG002|Outcome|Right Kidney|All subjects will have a right kidney injury identified by CT
11309413|NCT03147690|OG003|Outcome|Left Kidney|All subjects will have a left kidney injury identified by CT
11309414|NCT03147690|OG004|Outcome|Pancreas|All subjects will have a pancreas injury identified by CT
11309415|NCT03147690|OG000|Outcome|CT-Fluid|All subjects will have fluid identified by CT
11309416|NCT03147690|OG001|Outcome|CT-No Fluid|All subjects will have no fluid identified by CT
11309417|NCT03147690|OG000|Outcome|Liver|All subjects whose central review is complete
11309418|NCT03147690|OG001|Outcome|Spleen|All subjects whose central review is complete
11309419|NCT03147690|OG002|Outcome|Right Kidney|All subjects whose central review is complete
11309420|NCT03147690|OG003|Outcome|Left Kidney|All subjects whose central review is complete
11309421|NCT03147690|OG004|Outcome|Pancreas|All subjects whose central review is complete
11309422|NCT03147690|OG005|Outcome|All Organs|All subjects whose central review is complete
11309423|NCT03147690|EG000|Reported Event|All Study Participants|"All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL~Lumason: Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL."
11309424|NCT03148067|BG000|Baseline|Patients|"Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation~Intramedullary nailing for fracture fixation"
11309425|NCT03148067|FG000|Participant Flow|Patients|"221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up~Intramedullary nailing for fracture fixation"
10848540|NCT00290342|BG002|Baseline|Total|Total of all reporting groups
10848541|NCT00290342|FG000|Participant Flow|Infanrix-IPV Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
11309426|NCT03148067|OG000|Outcome|Patients|221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up. In total, 26 cases of infection were observed after 12 months of follow-up, with an incidence of 11.8%.
11309427|NCT03148067|OG000|Outcome|Patients|"221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up~Intramedullary nailing for fracture fixation"
11309428|NCT03148067|EG000|Reported Event|Patients|"221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up~Intramedullary nailing for fracture fixation"
11309429|NCT03148236|BG000|Baseline|Vitamin C|Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
11309430|NCT03148236|BG001|Baseline|Placebo|Placebo: 50mL infused over 30 minutes
11309431|NCT03148236|BG002|Baseline|Total|Total of all reporting groups
11309432|NCT03148236|FG000|Participant Flow|Vitamin C|Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
11309433|NCT03148236|FG001|Participant Flow|Placebo|Placebo: 50mL infused over 30 minutes
11309434|NCT03148236|OG000|Outcome|Vitamin C|Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
11309435|NCT03148236|OG001|Outcome|Placebo|Placebo: 50mL infused over 30 minutes
11309436|NCT03148236|EG000|Reported Event|Vitamin C|Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
11309437|NCT03148236|EG001|Reported Event|Placebo|Placebo: 50mL infused over 30 minutes
11309438|NCT03148262|BG000|Baseline|The High Flow Nasal Cannula|"The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy~The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation"
11309439|NCT03148262|BG001|Baseline|The Standard Nasal Cannula|"The Salter nasal cannula will be used during the colonoscopy~The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation."
11309440|NCT03148262|BG002|Baseline|Total|Total of all reporting groups
11309441|NCT03148262|FG000|Participant Flow|The High Flow Nasal Cannula|"The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy~The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation"
11309442|NCT03148262|FG001|Participant Flow|The Standard Nasal Cannula|"The Salter nasal cannula will be used during the colonoscopy~The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation."
11309443|NCT03148262|OG000|Outcome|The High Flow Nasal Cannula|"The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy~The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation"
11309444|NCT03148262|OG001|Outcome|The Standard Nasal Cannula|"The Salter nasal cannula will be used during the colonoscopy~The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation."
11309445|NCT03148262|EG000|Reported Event|The High Flow Nasal Cannula|"The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy~The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation"
11309446|NCT03148262|EG001|Reported Event|The Standard Nasal Cannula|"The Salter nasal cannula will be used during the colonoscopy~The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation."
11309447|NCT03148470|BG000|Baseline|Intermittent Theta Burst Stimulation|"intermittent theta burst stimulation (iTBS) + Sham iTBS~Sham iTBS: Placebo stimulation~intermittent theta burst stimulation (iTBS): Excitatory rTMS"
11309448|NCT03148470|BG001|Baseline|Continuous Theta Burst Stimulation|"continuous theta burst stimulation (cTBS) + Sham cTBS~Sham cTBS: Placebo stimulation~continuous theta burst stimulation (cTBS): inhibitory rTMS"
11309449|NCT03148470|BG002|Baseline|Total|Total of all reporting groups
11309450|NCT03148470|FG000|Participant Flow|iTBS Group|"intermittent theta burst stimulation (iTBS) + Sham iTBS~Sham iTBS: Placebo stimulation (3 Min)~Tasks (30 Min)~Pause (10Min)~iTBS: Excitatory stimulation (3Min)~Tasks (30Min)"
11309451|NCT03148470|FG001|Participant Flow|cTBS Group|"continuous theta burst stimulation (cTBS) + Sham cTBS~Sham cTBS: Placebo stimulation (40Sec)~Tasks (30min)~Pause (10Min)~cTBS: inhibitory stimulation (40 Sec)~Tasks (30Min)"
11309452|NCT03148470|OG000|Outcome|RTs for PN After Intermittent Theta Burst Stimulation|intermittent theta burst stimulation (iTBS) - across switching and non-switching blocks and across L1 and L2.
11309453|NCT03148470|OG001|Outcome|RTs for PN After Continuous Theta Burst Stimulation|continuous theta burst stimulation (cTBS) - across switching and non-switching blocks and across L1 and L2.
11309454|NCT03148470|OG002|Outcome|RTs for Picture Naming in L1|Voice onset times for Picture Naming in L1 - across switching and non-switching blocks and across iTBS and cTBS.
11309455|NCT03148470|OG003|Outcome|RTs for Picture Naming in L2|Voice onset times for Picture Naming in L2 - across switching and non-switching blocks and across iTBS and cTBS.
11309456|NCT03148470|OG004|Outcome|RTs for Picture Naming in the Non-switching Blocks|Voice onset times for Picture Naming in the non-switching blocks - across L1 and L2 and across iTBS and cTBS.
11309457|NCT03148470|OG005|Outcome|RTs for Picture Naming in the Switching Blocks|Voice onset times for Picture Naming in the switching blocks - across L1 and L2 and across iTBS and cTBS.
11309458|NCT03148470|OG000|Outcome|Intermittent Theta Burst Stimulation|intermittent theta burst stimulation (iTBS)
11309459|NCT03148470|OG001|Outcome|Continuous Theta Burst Stimulation|continuous theta burst stimulation (cTBS)
11309460|NCT03148470|EG000|Reported Event|cTBS|continuous theta burst stimulation (cTBS)
11309461|NCT03148470|EG001|Reported Event|iTBS|intermittent theta burst stimulation (iTBS)
11309462|NCT03148470|EG002|Reported Event|Sham iTBS|Placebo (baseline) stimulation for iTBS group
11309463|NCT03148470|EG003|Reported Event|Sham cTBS|Placebo (baseline) stimulation for cTBS group
11309464|NCT03148691|BG000|Baseline|Vehicle|"Vehicle Topical Solution~A-101: Topical Solution"
11309465|NCT03148691|BG001|Baseline|A-101 Low Dose|"A-101 Low Dose Topical Solution~A-101: Topical Solution"
11309466|NCT03148691|BG002|Baseline|A-101 High Dose|"A-101 High DoseTopical Solution~A-101: Topical Solution"
11309467|NCT03148691|BG003|Baseline|Total|Total of all reporting groups
11309468|NCT03148691|FG000|Participant Flow|Vehicle|"Vehicle Topical Solution~A-101: Topical Solution"
11309469|NCT03148691|FG001|Participant Flow|A-101 Low Dose|"A-101 Low Dose Topical Solution~A-101: Topical Solution"
11309470|NCT03148691|FG002|Participant Flow|A-101 High Dose|"A-101 High DoseTopical Solution~A-101: Topical Solution"
11309471|NCT03148691|OG000|Outcome|Vehicle|"Vehicle Topical Solution~A-101: Topical Solution"
11309472|NCT03148691|OG001|Outcome|A-101 Low Dose|"A-101 Low Dose Topical Solution~A-101: Topical Solution"
11309473|NCT03148691|OG002|Outcome|A-101 High Dose|"A-101 High DoseTopical Solution~A-101: Topical Solution"
11309474|NCT03148691|EG000|Reported Event|Vehicle|"Vehicle Topical Solution~A-101: Topical Solution"
11309475|NCT03148691|EG001|Reported Event|A-101 Low Dose|"A-101 Low Dose Topical Solution~A-101: Topical Solution"
11309476|NCT03148691|EG002|Reported Event|A-101 High Dose|"A-101 High DoseTopical Solution~A-101: Topical Solution"
11309477|NCT03149042|BG000|Baseline|CCTA|"Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.~CCTA Coronary: Diagnostic Test"
11309478|NCT03149042|FG000|Participant Flow|CCTA|"Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.~CCTA (Coronary CT angiography) Diagnostic Test"
11309479|NCT03149042|OG000|Outcome|CCTA|"Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.~CCTA Coronary: Diagnostic Test"
11309480|NCT03149042|OG000|Outcome|CCTA|"Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.~CCTA : Diagnostic Test"
11309481|NCT03149042|EG000|Reported Event|CCTA Coronary|"Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital and Juntendo University, Japan.~CCTA Coronary: Diagnostic Test"
11309482|NCT03149055|BG000|Baseline|Isavuconazole Prophylaxis|"Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.~Isavuconazole: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose."
11309483|NCT03149055|FG000|Participant Flow|Isavuconazole Prophylaxis|"Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.~Isavuconazole: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose."
11333111|NCT03508843|OG000|Outcome|Interactive Virtual Presence|"install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence~interactive virtual presence: installing the car seat with advice via interactive virtual presence"
11309484|NCT03149055|OG000|Outcome|Isavuconazole Prophylaxis|"Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.~Isavuconazole: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose."
11309485|NCT03149055|EG000|Reported Event|Isavuconazole Prophylaxis|"Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.~Isavuconazole: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose."
11309486|NCT03149172|BG000|Baseline|Equimatrix®|"Equimatrix® + Mucograft or alternatives~Equimatrix®: Ridge preservation bone grafting after tooth extraction"
11309487|NCT03149172|BG001|Baseline|Bio-Oss®|"Bio-Oss® + Mucograft or alternatives~Bio-Oss®: Ridge preservation bone grafting after tooth extraction"
11309488|NCT03149172|BG002|Baseline|Endobon®|"Endobon® + Mucograft or alternatives~Endobon®: Ridge preservation bone grafting after tooth extraction"
11309489|NCT03149172|BG003|Baseline|Total|Total of all reporting groups
11309490|NCT03149172|FG000|Participant Flow|Equimatrix®|"Equimatrix® + Mucograft or alternatives~Equimatrix®: Ridge preservation bone grafting after tooth extraction"
11309491|NCT03149172|FG001|Participant Flow|Bio-Oss®|"Bio-Oss® + Mucograft or alternatives~Bio-Oss®: Ridge preservation bone grafting after tooth extraction"
11309492|NCT03149172|FG002|Participant Flow|Endobon®|"Endobon® + Mucograft or alternatives~Endobon®: Ridge preservation bone grafting after tooth extraction"
11309493|NCT03149172|OG000|Outcome|Equimatrix®|"Equimatrix® + Mucograft or alternatives~Equimatrix®: Ridge preservation bone grafting after tooth extraction"
11309494|NCT03149172|OG001|Outcome|Bio-Oss®|"Bio-Oss® + Mucograft or alternatives~Bio-Oss®: Ridge preservation bone grafting after tooth extraction"
11309495|NCT03149172|OG002|Outcome|Endobon®|"Endobon® + Mucograft or alternatives~Endobon®: Ridge preservation bone grafting after tooth extraction"
11309496|NCT03149172|EG000|Reported Event|Equimatrix®|"Equimatrix® + Mucograft or alternatives~Equimatrix®: Ridge preservation bone grafting after tooth extraction"
11309497|NCT03149172|EG001|Reported Event|Bio-Oss®|"Bio-Oss® + Mucograft or alternatives~Bio-Oss®: Ridge preservation bone grafting after tooth extraction"
11309498|NCT03149172|EG002|Reported Event|Endobon®|"Endobon® + Mucograft or alternatives~Endobon®: Ridge preservation bone grafting after tooth extraction"
11309499|NCT03149328|BG000|Baseline|Clinician Support and Education Around Use of PROs in Home Dialysis Clinic|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.~Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.~Kidney Patient Population: Northern Alberta Renal Program (NARP)"
11309500|NCT03149328|BG001|Baseline|Usual Care|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinciains did not have access to participant's assessment responses.~Kidney Patient Population: Southern Alberta Renal Program (SARP)"
11309501|NCT03149328|BG002|Baseline|Total|Total of all reporting groups
11309502|NCT03149328|FG000|Participant Flow|Clinician Support and Education Around Use of PROs in Home Dialysis Clinic|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.~Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.~Kidney Patient Population: Northern Alberta Renal Program (NARP)"
11309503|NCT03149328|FG001|Participant Flow|Usual Care|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.~Kidney Patient Population: Southern Alberta Renal Program (SARP)"
11309504|NCT03149328|OG000|Outcome|Clinician Support and Education Around Use of PROs in Home Dialysis Clinic|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.~Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.~Kidney Patient Population: Northern Alberta Renal Program (NARP)"
11309505|NCT03149328|OG001|Outcome|Usual Care|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.~Kidney Patient Population: Southern Alberta Renal Program (SARP)"
11333112|NCT03508843|EG000|Reported Event|Interactive Virtual Presence|"install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence~interactive virtual presence: installing the car seat with advice via interactive virtual presence"
11333113|NCT03509350|BG000|Baseline|Treatment Protocol|Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
11309506|NCT03149328|EG000|Reported Event|Clinician Support and Education Around Use of PROs in Home Dialysis Clinic|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.~Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.~Kidney Patient Population: Northern Alberta Renal Program (NARP)"
11309507|NCT03149328|EG001|Reported Event|Usual Care|"In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.~Kidney Patient Population: Southern Alberta Renal Program (SARP)"
11309508|NCT03149848|BG000|Baseline|CAB 30 mg Followed by RBT 300 mg + CAB 30 mg|Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
11309509|NCT03149848|FG000|Participant Flow|CAB 30 mg Followed by RBT 300 mg + CAB 30 mg|Eligible participants received cabotegravir (CAB) 30 milligrams (mg) oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and rifabutin (RBT) 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
11309510|NCT03149848|OG000|Outcome|CAB 30 mg|Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
11309511|NCT03149848|OG001|Outcome|RBT 300 mg + CAB 30 mg|Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
11309512|NCT03149848|OG000|Outcome|CAB 30 mg Followed by RBT 300 mg + CAB 30 mg|Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
11309513|NCT03149848|EG000|Reported Event|CAB 30 mg|Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
11309514|NCT03149848|EG001|Reported Event|RBT 300 mg + CAB 30 mg|Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
11333114|NCT03509350|BG001|Baseline|Control Protocol|Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
11333115|NCT03509350|BG002|Baseline|Total|Total of all reporting groups
11333116|NCT03509350|FG000|Participant Flow|Treatment Protocol|Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
11333117|NCT03509350|FG001|Participant Flow|Control Protocol|Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
11333118|NCT03509350|OG000|Outcome|Treatment Protocol|Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
11333119|NCT03509350|OG001|Outcome|Control Protocol|Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
11333120|NCT03509350|EG000|Reported Event|Treatment Protocol|Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
11333121|NCT03509350|EG001|Reported Event|Control Protocol|Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
11333122|NCT03509675|BG000|Baseline|Placebo First, Then Ibuprofen Rinse|"Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.~Placebos: Placebo"
11333123|NCT03509675|BG001|Baseline|Ibuprofen Rinse First, Then Placebo|"The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.~Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients."
11333124|NCT03509675|BG002|Baseline|Total|Total of all reporting groups
11333125|NCT03509675|FG000|Participant Flow|Placebo First, Then Ibuprofen Rinse|"Subjects were asked to rinse 4 times per day with 5ml of placebo rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.~A seven day washout period was used after the placebo rinse, before commencing the ibuprofen rinse.~Placebos: Placebo"
11333126|NCT03509675|FG001|Participant Flow|Ibuprofen Rinse First, Then Placebo|"Subjects were asked to rinse 4 times per day with 5ml of ibuprofen suspension (5mg/100ml) as a rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.~A seven day washout period was used after the ibuprofen rinse, before commencing the placebo rinse.~Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients."
11333127|NCT03509675|OG000|Outcome|Placebo|"Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.~Placebos: Placebo"
11309515|NCT03149887|BG000|Baseline|Experimental (Liposomal Bupivacaine)|"Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.~Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection"
11309516|NCT03149887|BG001|Baseline|Control (Normal Saline)|"Injection of normal saline in surgical field at end of arthroscopic rotator cuff repair.~Placebo: Normal saline in volume equal to that of the liposomal bupivacine injected in experimental group"
11309517|NCT03149887|BG002|Baseline|Total|Total of all reporting groups
11309518|NCT03149887|FG000|Participant Flow|Experimental (Liposomal Bupivacaine)|"Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.~Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection"
11309519|NCT03149887|FG001|Participant Flow|Control (Normal Saline)|"Injection of Placebo solution in surgical field at end of arthroscopic rotator cuff repair.~Placebo: Normal saline in same volume as exparel injection in experimental group"
11309520|NCT03149887|OG000|Outcome|Experimental (Liposomal Bupivacaine)|"Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.~Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection"
11309521|NCT03149887|OG001|Outcome|Control (Normal Saline)|"Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.~Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group."
11309522|NCT03149887|EG000|Reported Event|Experimental (Liposomal Bupivacaine)|"Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.~Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection"
11309523|NCT03149887|EG001|Reported Event|Control (Normal Saline)|"Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.~Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group."
11309524|NCT03149991|BG000|Baseline|Ketamine/Brexpiprazole Arm|Brexpiprazole up to 3 mg/day for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309525|NCT03149991|BG001|Baseline|Ketamine/Placebo Arm|Placebo for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309526|NCT03149991|BG002|Baseline|Total|Total of all reporting groups
11309527|NCT03149991|FG000|Participant Flow|Ketamine/Brexpiprazole Arm|Brexpiprazole up to 3 mg/day for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309528|NCT03149991|FG001|Participant Flow|Ketamine/Placebo Arm|Placebo for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309529|NCT03149991|OG000|Outcome|Ketamine/Brexpiprazole Arm|Brexpiprazole up to 3 mg/day for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309530|NCT03149991|OG001|Outcome|Ketamine/Placebo Arm|Placebo for four weeks in combination with bi-weekly administration of intranasal ketamine (40 mg) for two weeks, followed by weekly administration of intranasal ketamine (40 mg) for two weeks
11309531|NCT03149991|EG000|Reported Event|Brexpiprazole|Brexpiprazole combined with intranasal ketamine
11309532|NCT03149991|EG001|Reported Event|Placebo|Placebo combined with intranasal ketamine
11309533|NCT03150043|BG000|Baseline|All Participants|"All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.~Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery"
11309534|NCT03150043|FG000|Participant Flow|All Participants|"All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.~Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery"
11309535|NCT03150043|OG000|Outcome|End of Case Non-invasive Hemogblobin|This value was obtained from the non-invasive device at the end of the case (hemoglobin g/dL).
11309536|NCT03150043|OG000|Outcome|All Participants|"All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.~Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery"
11309537|NCT03150043|EG000|Reported Event|All Participants|"All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.~Masimo Rainbow Pulse CO-oximeter: Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery"
11309538|NCT03150056|BG000|Baseline|GSK525762 60 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309539|NCT03150056|BG001|Baseline|GSK525762 60 mg Alternate+Abiraterone 1000 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309540|NCT03150056|BG002|Baseline|GSK525762 40 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309541|NCT03150056|BG003|Baseline|GSK525762 80 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309542|NCT03150056|BG004|Baseline|GSK525762 60 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309543|NCT03150056|BG005|Baseline|GSK525762 60 mg Alternate+Enzalutamide 160 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
11309544|NCT03150056|BG006|Baseline|Total|Total of all reporting groups
11309545|NCT03150056|FG000|Participant Flow|GSK525762 60 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309546|NCT03150056|FG001|Participant Flow|GSK525762 60 mg Alternate+Abiraterone 1000 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309547|NCT03150056|FG002|Participant Flow|GSK525762 40 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309548|NCT03150056|FG003|Participant Flow|GSK525762 80 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309549|NCT03150056|FG004|Participant Flow|GSK525762 60 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309550|NCT03150056|FG005|Participant Flow|GSK525762 60 mg Alternate+Enzalutamide 160 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
11309551|NCT03150056|OG000|Outcome|GSK525762 60 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309552|NCT03150056|OG001|Outcome|GSK525762 60 mg Alternate+Abiraterone 1000 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309553|NCT03150056|OG002|Outcome|GSK525762 40 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309554|NCT03150056|OG003|Outcome|GSK525762 80 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309555|NCT03150056|OG004|Outcome|GSK525762 60 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309556|NCT03150056|OG005|Outcome|GSK525762 60 mg Alternate+Enzalutamide 160 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
11309557|NCT03150056|OG000|Outcome|GSK525762 80 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309558|NCT03150056|OG001|Outcome|GSK525762 60 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309559|NCT03150056|OG002|Outcome|GSK525762 60 mg Alternate+Enzalutamide 160 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
11309560|NCT03150056|EG000|Reported Event|GSK525762 60 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309561|NCT03150056|EG001|Reported Event|GSK525762 60 mg Alternate+Abiraterone 1000 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309562|NCT03150056|EG002|Reported Event|GSK525762 40 mg+Abiraterone 1000 mg|Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
11309563|NCT03150056|EG003|Reported Event|GSK525762 80 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309564|NCT03150056|EG004|Reported Event|GSK525762 60 mg+Enzalutamide 160 mg|Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
11309565|NCT03150056|EG005|Reported Event|GSK525762 60 mg Alternate+Enzalutamide 160 mg|Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
11309566|NCT03150082|BG000|Baseline|All Participants|Eligible participants received a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309567|NCT03150082|FG000|Participant Flow|GR37547 Followed by Ciprofloxacin Reference Product|Eligible participants received a single dose of Treatment A (GR37547 500 mg tablet), administered orally on Day 1 in treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received Treatment B (ciprofloxacin 500 mg reference tablet), administered orally on Day 1 in treatment period 2.
11309568|NCT03150082|FG001|Participant Flow|Ciprofloxacin Reference Product Followed by GR37547|Eligible participants received Treatment B (ciprofloxacin 500 mg reference tablet), administered orally on Day 1 in treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received a single dose of Treatment A (GR37547 500 mg tablet), administered orally on Day 1 in treatment period 2.
11309569|NCT03150082|OG000|Outcome|Ciprofloxacin 500 mg Reference|Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309570|NCT03150082|OG001|Outcome|GR37547 500 mg|Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309571|NCT03150082|OG000|Outcome|GR37547 500 mg|Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309572|NCT03150082|OG001|Outcome|Ciprofloxacin 500 mg Reference|Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309573|NCT03150082|EG000|Reported Event|GR37547 500 mg|Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309574|NCT03150082|EG001|Reported Event|Ciprofloxacin 500 mg Reference|Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11309575|NCT03150108|BG000|Baseline|Non-Hispanic Caucasians|Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single SC injection of 100 mcg rhPTH[1-84] on Day 1.
11309576|NCT03150108|BG001|Baseline|Participants of Japanese Descent|Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1, then followed by either 25 mcg or 50 mcg SC injection on Days 4 and 7 in a cross-over fashion. A washout period of 73 hours was maintained between each single doses (100 mcg, 50 mcg and 25 mcg).
11309577|NCT03150108|BG002|Baseline|Total|Total of all reporting groups
11309578|NCT03150108|FG000|Participant Flow|Non-Hispanic Caucasians|Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH[1-84]) on Day 1.
11309579|NCT03150108|FG001|Participant Flow|Participants of Japanese Descent|Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1, then followed by either 25 mcg or 50 mcg SC injection on Days 4 and 7 in a cross-over fashion. A washout period of 73 hours was maintained between each single doses (100 mcg, 50 mcg and 25 mcg).
11309580|NCT03150108|OG000|Outcome|Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)|Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH[1-84]) on Day 1.
11309581|NCT03150108|OG001|Outcome|Participants of Japanese Descent: 100 mcg rhPTH(1-84)|Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
11309582|NCT03150108|OG002|Outcome|Participants of Japanese Descent: 50 mcg rhPTH(1-84)|Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
11309583|NCT03150108|OG003|Outcome|Participants of Japanese Descent: 25 mcg rhPTH(1-84)|Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
11309584|NCT03150108|OG000|Outcome|Non-Hispanic Caucasians:100 mcg rhPTH(1-84)|Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH[1-84]) on Day 1.
11309585|NCT03150108|OG000|Outcome|Non-Hispanic Caucasians:100 mcg rhPTH(1-84)|Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
11309586|NCT03150108|OG001|Outcome|Participants of Japanese Descent: 100 mcg rhPTH(1-84)|Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
11309587|NCT03150108|OG002|Outcome|Participants of Japanese Descent: 50 mcg rhPTH(1-84)|Participants received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
11309588|NCT03150108|OG003|Outcome|Participants of Japanese Descent: 25 mcg rhPTH(1-84)|Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
11309589|NCT03150108|EG000|Reported Event|Non-Hispanic Caucasians:100 mcg rhPTH(1- 84)|Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
11309590|NCT03150108|EG001|Reported Event|Participants of Japanese Descent: 100 mcg rhPTH(1-84)|Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
11309591|NCT03150108|EG002|Reported Event|Participants of Japanese Descent: 50 mcg rhPTH(1-84)|Participants received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
11309592|NCT03150108|EG003|Reported Event|Participants of Japanese Descent: 25 mcg rhPTH(1-84)|Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
11309593|NCT03150199|BG000|Baseline|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology+Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11309594|NCT03150199|BG001|Baseline|MI-Based Health Education Intervention|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet) and will use motivational interviewing techniques to facilitate the consideration of behavior change.~MI-based Health Education Intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior."
11309595|NCT03150199|BG002|Baseline|Total|Total of all reporting groups
11309596|NCT03150199|FG000|Participant Flow|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology+Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11309597|NCT03150199|FG001|Participant Flow|MI-Based Health Education Intervention|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet) and will use motivational interviewing techniques to facilitate the consideration of behavior change.~MI-based Health Education Intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior."
11309598|NCT03150199|OG000|Outcome|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology+Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11333128|NCT03509675|OG001|Outcome|Ibuprofen Rinse|"The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.~Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients."
11333129|NCT03509675|EG000|Reported Event|Placebo|"Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.~Placebos: Placebo"
11309599|NCT03150199|OG001|Outcome|MI-based Health Education Intervention|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet) and will use motivational interviewing techniques to facilitate the consideration of behavior change.~MI-based Health Education Intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior."
11309600|NCT03150199|OG001|Outcome|MI-Based Health Education Intervention|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet) and will use motivational interviewing techniques to facilitate the consideration of behavior change.~MI-based Health Education Intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior."
11309601|NCT03150199|EG000|Reported Event|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology+Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11309602|NCT03150199|EG001|Reported Event|MI-based Health Educational Intervention|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet) and will use motivational interviewing techniques to facilitate the consideration of behavior change.~MI-based Health Education Intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior."
11309603|NCT03150485|BG000|Baseline|Dispensed Subjects|All subjects dispensed at least one study lens.
11309604|NCT03150485|FG000|Participant Flow|Multifocal|Subjects that wore the etafilcon A multifocal lens in both eyes for the entire duration of the study.
11309605|NCT03150485|FG001|Participant Flow|Toric Multifocal|Subjects that wore the etafilcon A Toric multifocal lens in both eyes for the entire duration of the study.
11309606|NCT03150485|FG002|Participant Flow|Toric Multifocal/Multifocal|Subjects that wore the etafilcon A toric multifocal lens in their right eye and the etafilcon A multifocal lens in their left eye for the entire duration of the study.
11309607|NCT03150485|FG003|Participant Flow|Multifocal/Toric Multifocal|Subjects that wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye for the entire duration of the study.
11309608|NCT03150485|FG004|Participant Flow|Multifocal/Toric Multifocal -Toric Multifocal|Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye and then wore the etafilcon A toric multifocal lens in both eyes for the remainder of the study.
11309609|NCT03150485|FG005|Participant Flow|Multifocal/Toric Multifocal - Multifocal -Toric Multifocal|Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye. Then wore the etafilcon A multifocal lens in both eyes secondary and lastly wore then etafilcon A toric multifocal lens in both eyes for the remainder of the study.
11309610|NCT03150485|OG000|Outcome|JJVC Fitting Guides|ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
11309611|NCT03150485|EG000|Reported Event|Multifocal|Subjects that wore the etafilcon A multifocal lens in either or both eyes at least once during the course of the study
11309612|NCT03150485|EG001|Reported Event|Toric Multifocal|Subjects that wore the etafilcon A Toric multifocal lens in either or both eyes at least once during the course of the study.
11309613|NCT03150589|BG000|Baseline|SB11 (Proposed Ranibizumab Biosimilar)|SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
11309614|NCT03150589|BG001|Baseline|Lucentis (Ranibizumab)|Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
11309615|NCT03150589|BG002|Baseline|Total|Total of all reporting groups
11309616|NCT03150589|FG000|Participant Flow|SB11 (Proposed Ranibizumab Biosimilar)|SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
11309617|NCT03150589|FG001|Participant Flow|Lucentis (Ranibizumab)|Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
11309618|NCT03150589|OG000|Outcome|SB11 (Proposed Ranibizumab Biosimilar)|SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
11309619|NCT03150589|OG001|Outcome|Lucentis (Ranibizumab)|Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
11309620|NCT03150589|EG000|Reported Event|SB11 (Proposed Ranibizumab Biosimilar)|SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
11309621|NCT03150589|EG001|Reported Event|Lucentis (Ranibizumab)|Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
11309622|NCT03150719|BG000|Baseline|Placebo|Participants received placebo matched to TEZ/IVA fixed-dose combination tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 56 days.
11309623|NCT03150719|BG001|Baseline|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed-dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 56 days.
11309624|NCT03150719|BG002|Baseline|Total|Total of all reporting groups
11309625|NCT03150719|FG000|Participant Flow|Placebo|Participants received placebo matched to TEZ/IVA fixed-dose combination tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 56 days.
11309626|NCT03150719|FG001|Participant Flow|TEZ/IVA|Participants received TEZ 100 milligram (mg)/IVA 150 mg fixed-dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 56 days.
11309627|NCT03150719|OG000|Outcome|Placebo|Participants received placebo matched to TEZ/IVA fixed-dose combination tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 56 days.
11309628|NCT03150719|OG001|Outcome|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed-dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 56 days.
11309629|NCT03150719|EG000|Reported Event|Placebo|Participants received placebo matched to TEZ/IVA fixed-dose combination tablet orally once daily in the morning followed by placebo matched to IVA tablet orally once daily in the evening for 56 days.
11309630|NCT03150719|EG001|Reported Event|TEZ/IVA|Participants received TEZ 100 mg/IVA 150 mg fixed-dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 56 days.
11309631|NCT03150758|BG000|Baseline|Electrical Stimulation|"Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded~10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds~10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds~7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds~7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds"
11309632|NCT03150758|FG000|Participant Flow|Electrical Stimulation|"Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded~10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds~10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds~7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds~7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds"
11309633|NCT03150758|OG000|Outcome|Electrical Stimulation|"Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded~10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds~10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds~7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds~7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds"
11309634|NCT03150758|EG000|Reported Event|Electrical Stimulation|"Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded~10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds~10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds~7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds~7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds"
11309635|NCT03150875|BG000|Baseline|Sintilimab|Sintilimab 200mg Intravenously every 3 weeks
11309636|NCT03150875|BG001|Baseline|Docetaxel|Docetaxel 75mg/m2 Intravenously every 3 weeks
11309637|NCT03150875|BG002|Baseline|Total|Total of all reporting groups
11309638|NCT03150875|FG000|Participant Flow|Sintilimab|Sintilimab 200mg Intravenously every 3 weeks
11309639|NCT03150875|FG001|Participant Flow|Docetaxel|Docetaxel 75mg/m2 Intravenously every 3 weeks
11309640|NCT03150875|OG000|Outcome|Sintilimab|Sintilimab 200mg Intravenously every 3 weeks
11309641|NCT03150875|OG001|Outcome|Docetaxel|Docetaxel 75mg/m2 Intravenously every 3 weeks
11309642|NCT03150875|EG000|Reported Event|Sintilimab|Sintilimab 200mg Intravenously every 3 weeks
11309643|NCT03150875|EG001|Reported Event|Docetaxel|Docetaxel 75mg/m2 Intravenously every 3 weeks
11309644|NCT03151148|BG000|Baseline|TMT Lotion|"The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.~Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309645|NCT03151148|BG001|Baseline|Placebo Lotion|"Placebo lotion was provided in single-dose sealed packets.~Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309646|NCT03151148|BG002|Baseline|Total|Total of all reporting groups
11309647|NCT03151148|FG000|Participant Flow|TMT Lotion|"The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.~Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309648|NCT03151148|FG001|Participant Flow|Placebo Lotion|"Placebo lotion was provided in single-dose sealed packets.~Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309649|NCT03151148|OG000|Outcome|Targeted Microbiome Transplant (TMT)|"The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.~Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309650|NCT03151148|OG001|Outcome|Placebo Lotion|"Placebo lotion was provided in single-dose sealed packets.~Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309651|NCT03151148|OG000|Outcome|TMT Lotion|"The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.~Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309652|NCT03151148|EG000|Reported Event|Targeted Microbiome Transplant (TMT)|"The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.~Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309653|NCT03151148|EG001|Reported Event|Placebo Lotion|"Placebo lotion was provided in single-dose sealed packets.~Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week."
11309654|NCT03151265|BG000|Baseline|Low Back Pain Group|"Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309655|NCT03151265|BG001|Baseline|Active in Sport Group|"Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309656|NCT03151265|BG002|Baseline|Total|Total of all reporting groups
11309657|NCT03151265|FG000|Participant Flow|Low Back Pain Group|"Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309658|NCT03151265|FG001|Participant Flow|Active in Sport Group|"Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility and muscle relaxation.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309659|NCT03151265|OG000|Outcome|Low Back Pain Group|"Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309660|NCT03151265|OG001|Outcome|Active in Sport Group|"Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309661|NCT03151265|EG000|Reported Event|Low Back Pain Group|"Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309662|NCT03151265|EG001|Reported Event|Active in Sport Group|"Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain.~The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.~ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours."
11309663|NCT03151395|BG000|Baseline|Total Group|Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
11309664|NCT03151395|FG000|Participant Flow|Total Group|Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
11309665|NCT03151395|OG000|Outcome|Total Group|Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
11309666|NCT03151395|EG000|Reported Event|Total Group|Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
11309667|NCT03151434|BG000|Baseline|US Guided Single Shot Paravertebral Block|"group 1- US Guided Single Shot Paravertebral Block~US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309668|NCT03151434|BG001|Baseline|US Guided Paravertebral Catheter|"group 2- US Guided Paravertebral Catheter~US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309669|NCT03151434|BG002|Baseline|Thoracic Epidural|"group 3- Thoracic Epidural~Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery."
11309670|NCT03151434|BG003|Baseline|Total|Total of all reporting groups
11309671|NCT03151434|FG000|Participant Flow|Group #1|"US Guided Single Shot Paravertebral Block~US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309672|NCT03151434|FG001|Participant Flow|Group #2|"US Guided Paravertebral Catheter~US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309673|NCT03151434|FG002|Participant Flow|Group #3|"Thoracic Epidural~Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery."
11309674|NCT03151434|OG000|Outcome|US Guided Single Shot Paravertebral Block|"group 1- US Guided Single Shot Paravertebral Block~US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309675|NCT03151434|OG001|Outcome|US Guided Paravertebral Catheter|"group 2- US Guided Paravertebral Catheter~US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309676|NCT03151434|OG002|Outcome|Thoracic Epidural|"group 3- Thoracic Epidural~Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery."
11309677|NCT03151434|OG000|Outcome|Group #1|"US Guided Single Shot Paravertebral Block~US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309678|NCT03151434|OG001|Outcome|Group #2|"US Guided Paravertebral Catheter~US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309679|NCT03151434|OG002|Outcome|Group #3|"Thoracic Epidural~Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery."
11309680|NCT03151434|EG000|Reported Event|US Guided Single Shot Paravertebral Block|"group 1- US Guided Single Shot Paravertebral Block~US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309681|NCT03151434|EG001|Reported Event|US Guided Paravertebral Catheter|"group 2- US Guided Paravertebral Catheter~US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery."
11309682|NCT03151434|EG002|Reported Event|Thoracic Epidural|"group 3- Thoracic Epidural~Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery."
11309683|NCT03151551|BG000|Baseline|Ixekizumab|"160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.~80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.~80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps."
11309684|NCT03151551|BG001|Baseline|Adalimumab|"80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.~40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps."
11309685|NCT03151551|BG002|Baseline|Total|Total of all reporting groups
11309686|NCT03151551|FG000|Participant Flow|Ixekizumab|"160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.~80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.~80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.~Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period."
11309687|NCT03151551|FG001|Participant Flow|Adalimumab|"80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.~40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.~Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period."
11309688|NCT03151551|OG000|Outcome|Ixekizumab|"160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.~80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.~80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps."
11309689|NCT03151551|OG001|Outcome|Adalimumab|"80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.~40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps."
11309690|NCT03151551|EG000|Reported Event|Ixekizumab|"160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.~80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.~80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps."
11309691|NCT03151551|EG001|Reported Event|Adalimumab|"80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.~40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps."
11309692|NCT03151551|EG002|Reported Event|Ixekizumab Follow-up|Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
11309693|NCT03151551|EG003|Reported Event|Adalimumab Follow-up|Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
11309694|NCT03152019|BG000|Baseline|Protopic® 0.1% (Tacrolimus) Ointment|"Protopic® 0.1% ointment, packed in blinded tube of 30g.~Protopic® (Tacrolimus) 0.1% ointment: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309695|NCT03152019|BG001|Baseline|Placebo Ointment|"Same formulation as the Protopic® 0.1% ointment but without tacrolimus, packed in blinded tube of 30g.~Placebo: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309696|NCT03152019|BG002|Baseline|Total|Total of all reporting groups
11309697|NCT03152019|FG000|Participant Flow|Protopic® 0.1% (Tacrolimus) Ointment|"Protopic® 0.1% ointment, packed in blinded tube of 30g.~Protopic® (Tacrolimus) 0.1% ointment: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309698|NCT03152019|FG001|Participant Flow|Placebo Ointment|"Same formulation as the Protopic® 0.1% ointment but without tacrolimus, packed in blinded tube of 30g.~Placebo: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309699|NCT03152019|OG000|Outcome|Protopic® 0.1% (Tacrolimus) Ointment|"Protopic® 0.1% ointment, packed in blinded tube of 30g.~Protopic® (Tacrolimus) 0.1% ointment: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309700|NCT03152019|OG001|Outcome|Placebo Ointment|"Same formulation as the Protopic® 0.1% ointment but without tacrolimus, packed in blinded tube of 30g.~Placebo: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309701|NCT03152019|EG000|Reported Event|Protopic® 0.1% (Tacrolimus) Ointment|"Protopic® 0.1% ointment, packed in blinded tube of 30g.~Protopic® (Tacrolimus) 0.1% ointment: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309702|NCT03152019|EG001|Reported Event|Placebo Ointment|"Same formulation as the Protopic® 0.1% ointment but without tacrolimus, packed in blinded tube of 30g.~Placebo: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks."
11309703|NCT03152084|BG000|Baseline|Group 2|Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309704|NCT03152084|BG001|Baseline|Group 3|Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309705|NCT03152084|BG002|Baseline|Total|Total of all reporting groups
11309706|NCT03152084|FG000|Participant Flow|Group 2|Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309707|NCT03152084|FG001|Participant Flow|Group 3|Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309708|NCT03152084|OG000|Outcome|Group 2|Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309709|NCT03152084|OG001|Outcome|Group 3|Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309710|NCT03152084|EG000|Reported Event|Group 2|Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309711|NCT03152084|EG001|Reported Event|Group 3|Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
11309712|NCT03152110|BG000|Baseline|HIIT|"Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised).~HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters"
11309713|NCT03152110|FG000|Participant Flow|HIIT|"Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised).~HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters"
11309714|NCT03152110|OG000|Outcome|HIIT|"Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised).~HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs.~Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed"
11309715|NCT03152110|OG000|Outcome|HIIT|"Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised).~HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters"
11309716|NCT03152110|EG000|Reported Event|HIIT|"Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised).~HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs.~Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed"
11309717|NCT03152136|BG000|Baseline|TAPS|"Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309718|NCT03152136|BG001|Baseline|Sham|"Subjects will receive a Cala ONE device that delivers sham stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309719|NCT03152136|BG002|Baseline|No Intervention|Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
11309720|NCT03152136|BG003|Baseline|Total|Total of all reporting groups
11309721|NCT03152136|FG000|Participant Flow|TAPS|"Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309722|NCT03152136|FG001|Participant Flow|Sham|"Subjects will receive a Cala ONE device that delivers sham stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309723|NCT03152136|FG002|Participant Flow|No Intervention|Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
11309724|NCT03152136|OG000|Outcome|TAPS|"Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309725|NCT03152136|OG001|Outcome|Sham|"Subjects will receive a Cala ONE device that delivers sham stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309726|NCT03152136|EG000|Reported Event|TAPS|"Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309727|NCT03152136|EG001|Reported Event|Sham|"Subjects will receive a Cala ONE device that delivers sham stimulation.~Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves."
11309728|NCT03152136|EG002|Reported Event|No Intervention|Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
11309729|NCT03152552|BG000|Baseline|LIK066 2.5mg|LIK066 2.5mg once daily
11309730|NCT03152552|BG001|Baseline|LIK066 10mg|LIk066 10mg once daily
11309731|NCT03152552|BG002|Baseline|LIK066 50mg|LIK066 50mg once daily
11309732|NCT03152552|BG003|Baseline|EMPA 25mg|Empagliflozin 25 mg once daily
11309733|NCT03152552|BG004|Baseline|Placebo|LIK066 matching placebo and empagliflozin matching placebo
11309734|NCT03152552|BG005|Baseline|Total|Total of all reporting groups
10848542|NCT00290342|FG001|Participant Flow|Infanrix + IMOVAX Polio Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
11309735|NCT03152552|FG000|Participant Flow|LIK066 2.5mg|LIK066 2.5mg once daily
11309736|NCT03152552|FG001|Participant Flow|LIK066 10mg|LIk066 10mg once daily
11309737|NCT03152552|FG002|Participant Flow|LIK066 50mg|LIK066 50mg once daily
11309738|NCT03152552|FG003|Participant Flow|EMPA 25mg|Empagliflozin 25 mg once daily
11309739|NCT03152552|FG004|Participant Flow|Placebo|LIK066 matching placebo and empagliflozin matching placebo
11309740|NCT03152552|OG000|Outcome|LIK066 2.5mg|LIK066 2.5mg once daily
11309741|NCT03152552|OG001|Outcome|LIK066 10mg|LIk066 10mg once daily
11309742|NCT03152552|OG002|Outcome|LIK066 50mg|LIK066 50mg once daily
11309743|NCT03152552|OG003|Outcome|Placebo|LIK066 matching placebo and empagliflozin matching placebo
11309744|NCT03152552|OG003|Outcome|EMPA 25mg|Empagliflozin 25 mg once daily
11309745|NCT03152552|OG004|Outcome|Placebo|LIK066 matching placebo and empagliflozin matching placebo
11309746|NCT03152552|EG000|Reported Event|LIK066 2.5mg|LIK066 2.5mg once daily
11309747|NCT03152552|EG001|Reported Event|LIK066 10mg|LIK066 10mg once daily
11309748|NCT03152552|EG002|Reported Event|LIK066 50mg|LIK066 50mg once daily
11309749|NCT03152552|EG003|Reported Event|EMPA 25mg|Empagliflozin 25 mg once daily
11309750|NCT03152552|EG004|Reported Event|Placebo|LIK066 matching placebo and empagliflozin matching placebo
11309751|NCT03152591|BG000|Baseline|LIK066|LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309752|NCT03152591|BG001|Baseline|Placebo|Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309753|NCT03152591|BG002|Baseline|Total|Total of all reporting groups
11309754|NCT03152591|FG000|Participant Flow|LIK066|LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309755|NCT03152591|FG001|Participant Flow|Placebo|Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309756|NCT03152591|OG000|Outcome|LIK066|LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309757|NCT03152591|OG001|Outcome|Placebo|Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309758|NCT03152591|EG000|Reported Event|LIK066|LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309759|NCT03152591|EG001|Reported Event|Placebo|Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
11309760|NCT03153956|BG000|Baseline|Active Treatment Arm|"Personally calibrated bio-mechanical device~Calibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology."
11309761|NCT03153956|BG001|Baseline|Control Arm|"sham-placebo device (similar shoes without bio-mechanical elements).~Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device."
11309762|NCT03153956|BG002|Baseline|Total|Total of all reporting groups
11309763|NCT03153956|FG000|Participant Flow|Active Treatment Arm|"Personally calibrated bio-mechanical device~Calibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology."
11309764|NCT03153956|FG001|Participant Flow|Control Arm|"sham-placebo device (similar shoes without bio-mechanical elements).~Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device."
11309765|NCT03153956|OG000|Outcome|Active Treatment Arm|"Personally calibrated bio-mechanical device~Calibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology."
11309766|NCT03153956|OG001|Outcome|Control Arm|"sham-placebo device (similar shoes without bio-mechanical elements).~Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device."
11309767|NCT03153956|EG000|Reported Event|Active Treatment Arm|"Personally calibrated bio-mechanical device~Calibrated AposTherapy®: a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology."
11309768|NCT03153956|EG001|Reported Event|Control Arm|"sham-placebo device (similar shoes without bio-mechanical elements).~Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device."
11309769|NCT03154047|BG000|Baseline|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 36 months
11309770|NCT03154047|FG000|Participant Flow|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 36 months
11309771|NCT03154047|OG000|Outcome|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 4 weeks
11309772|NCT03154047|EG000|Reported Event|NEOD001 24 mg/kg|NEOD001, 24 mg/kg IV every 4 weeks for 36 months
11309773|NCT03154086|BG000|Baseline|Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg|Participants received single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309774|NCT03154086|BG001|Baseline|Part A:Cohort 1:GSK3352589 2mg/Placebo/GSK3352589 15mg/50mg|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309775|NCT03154086|BG002|Baseline|Part A:Cohort 1: GSK3352589 2mg/ 5mg/Placebo/ GSK3352589 50mg|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309776|NCT03154086|BG003|Baseline|Part A:Cohort 1:GSK3352589 2mg/5mg/15mg/Placebo|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309777|NCT03154086|BG004|Baseline|Part A:Cohort 2:GSK3352589 25 mg Fasted/GSK3352589 25 mg Fed|Participants received single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309778|NCT03154086|BG005|Baseline|Part A: Cohort 2: Placebo Fasted/Placebo Fed|Participants received single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309779|NCT03154086|BG006|Baseline|Part A:Cohort 3: GSK3352589 150 mg/Placebo|Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309780|NCT03154086|BG007|Baseline|Part A:Cohort 3: Placebo /GSK3352589 400 mg|Participants received single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309781|NCT03154086|BG008|Baseline|Part A:Cohort 3: GSK3352589 150 mg/GSK3352589 400 mg|Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309782|NCT03154086|BG009|Baseline|Part B: Placebo BID|Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
11309783|NCT03154086|BG010|Baseline|Part B: GSK3352589 5 mg BID|Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
11309784|NCT03154086|BG011|Baseline|Part B: GSK3352589 15 mg BID|Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
11309785|NCT03154086|BG012|Baseline|Part B: GSK3352589 50 mg BID|Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
11309786|NCT03154086|BG013|Baseline|Part B: GSK3352589 100 mg BID|Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
11309787|NCT03154086|BG014|Baseline|Part B: GSK3352589 200 mg BID|Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
11309788|NCT03154086|BG015|Baseline|Total|Total of all reporting groups
11309789|NCT03154086|FG000|Participant Flow|Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg|Participants received single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309790|NCT03154086|FG001|Participant Flow|Part A:Cohort 1:GSK3352589 2mg/Placebo/GSK3352589 15mg/50mg|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309791|NCT03154086|FG002|Participant Flow|Part A:Cohort 1: GSK3352589 2mg/ 5mg/Placebo/ GSK3352589 50mg|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309792|NCT03154086|FG003|Participant Flow|Part A:Cohort 1:GSK3352589 2mg/5mg/15mg/Placebo|Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309793|NCT03154086|FG004|Participant Flow|Part A:Cohort 2:GSK3352589 25 mg Fasted/GSK3352589 25 mg Fed|Participants received single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309794|NCT03154086|FG005|Participant Flow|Part A: Cohort 2: Placebo Fasted/Placebo Fed|Participants received single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309795|NCT03154086|FG006|Participant Flow|Part A:Cohort 3: GSK3352589 150 mg/Placebo|Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309796|NCT03154086|FG007|Participant Flow|Part A:Cohort 3: Placebo /GSK3352589 400 mg|Participants received single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309797|NCT03154086|FG008|Participant Flow|Part A:Cohort 3: GSK3352589 150 mg/GSK3352589 400 mg|Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
11309798|NCT03154086|FG009|Participant Flow|Part B: Placebo BID|Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
11309799|NCT03154086|FG010|Participant Flow|Part B: GSK3352589 5 mg BID|Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
11309800|NCT03154086|FG011|Participant Flow|Part B: GSK3352589 15 mg BID|Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
11309801|NCT03154086|FG012|Participant Flow|Part B: GSK3352589 50 mg BID|Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
11309802|NCT03154086|FG013|Participant Flow|Part B: GSK3352589 100 mg BID|Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
11309803|NCT03154086|FG014|Participant Flow|Part B: GSK3352589 200 mg BID|Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
11309804|NCT03154086|OG000|Outcome|Part A: Cohort 1: Placebo|Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
11309805|NCT03154086|OG001|Outcome|Part A: Cohort 1: GSK3352589 2 mg|Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
11309806|NCT03154086|OG002|Outcome|Part A: Cohort 1: GSK3352589 5 mg|Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
11309807|NCT03154086|OG003|Outcome|Part A: Cohort 1: GSK3352589 15 mg|Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
11309808|NCT03154086|OG004|Outcome|Part A: Cohort 1: GSK3352589 50 mg|Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
11309809|NCT03154086|OG000|Outcome|Part A: Cohort 2: Fasted Placebo|Participants received placebo tablet matching GSK3352589 without food in Period 1 of Cohort 2 in Part A of the study.
11309810|NCT03154086|OG001|Outcome|Part A: Cohort 2: Fed Placebo|Participants received placebo tablet matching GSK3352589 with food in Period 2 of Cohort 2 in Part A of the study.
11309811|NCT03154086|OG002|Outcome|Part A: Cohort 2: GSK3352589 Fasted 25 mg|Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
11309812|NCT03154086|OG003|Outcome|Part A: Cohort 2: GSK3352589 Fed 25 mg|Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
11309813|NCT03154086|OG000|Outcome|Part A: Cohort 3: Placebo|Participants received placebo tablet matching GSK3352589 in one of the Periods of Cohort 3 in Part A of the study.
11309814|NCT03154086|OG001|Outcome|Part A: Cohort 3: GSK3352589 150 mg|Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
11309815|NCT03154086|OG002|Outcome|Part A: Cohort 3: GSK3352589 400 mg|Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
10848543|NCT00290342|OG000|Outcome|Infanrix-IPV Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
11309816|NCT03154086|OG000|Outcome|Part B: Placebo BID|Participants received repeat doses of placebo BID administered for 14 days in Part B of the study.
11309817|NCT03154086|OG001|Outcome|Part B: GSK3352589 5 mg BID|Participants received repeat doses of GSK3352589 5 mg BID administered for 14 days in Part B of the study.
11309818|NCT03154086|OG002|Outcome|Part B: GSK3352589 15 mg BID|Participants received repeat doses of GSK3352589 15 mg BID administered for 14 days in Part B of the study.
11309819|NCT03154086|OG003|Outcome|Part B: GSK3352589 50 mg BID|Participants received repeat doses of GSK3352589 50 mg BID administered for 14 days in Part B of the study.
11309820|NCT03154086|OG004|Outcome|Part B: GSK3352589 100 mg BID|Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
11309821|NCT03154086|OG005|Outcome|Part B: GSK3352589 200 mg BID|Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
11309822|NCT03154086|OG000|Outcome|Part A: Cohort 1 and 3: Placebo|Participants received placebo tablet matching GSK3352589 in one of the Periods of Cohort 1 and Cohort 3 in Part A of the study.
11309823|NCT03154086|OG005|Outcome|Part A:Cohort 3: GSK3352589 150 mg|Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
11309824|NCT03154086|OG006|Outcome|Part A:Cohort 3: GSK3352589 400 mg|Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
11309825|NCT03154086|OG000|Outcome|Part A: Cohort 1: GSK3352589 2 mg|Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
11309826|NCT03154086|OG001|Outcome|Part A: Cohort 1: GSK3352589 5 mg|Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
11309827|NCT03154086|OG002|Outcome|Part A: Cohort 1: GSK3352589 15 mg|Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
11309828|NCT03154086|OG003|Outcome|Part A: Cohort 1: GSK3352589 50 mg|Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
11309829|NCT03154086|OG004|Outcome|Part A: Cohort 2: GSK3352589 Fasted 25 mg|Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
11309830|NCT03154086|OG005|Outcome|Part A: Cohort 2: GSK3352589 Fed 25 mg|Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
11309831|NCT03154086|OG006|Outcome|Cohort 3: GSK3352589 150 mg|Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
11309832|NCT03154086|OG007|Outcome|Cohort 3: GSK3352589 400 mg|Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
11309833|NCT03154086|OG000|Outcome|Part A: Cohort 2: GSK3352589 Fasted 25 mg|Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
11309834|NCT03154086|OG001|Outcome|Part A: Cohort 2: GSK3352589 Fed 25 mg|Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
11309835|NCT03154086|OG000|Outcome|Part B: GSK3352589 5 mg BID|Participants received repeat doses of GSK3352589 5 mg BID administered for 14 days in Part B of the study.
11309836|NCT03154086|OG001|Outcome|Part B: GSK3352589 15 mg BID|Participants received repeat doses of GSK3352589 15 mg BID administered for 14 days in Part B of the study.
11309837|NCT03154086|OG002|Outcome|Part B: GSK3352589 50 mg BID|Participants received repeat doses of GSK3352589 50 mg BID administered for 14 days in Part B of the study.
11309838|NCT03154086|OG003|Outcome|Part B: GSK3352589 100 mg BID|Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
11309839|NCT03154086|OG004|Outcome|Part B: GSK3352589 200 mg BID|Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
11309840|NCT03154086|EG000|Reported Event|Part A: Cohort 1: Placebo|Participants received placebo tablet matching GSK3352589 orally in each Period of Cohort 1 in Part A of the study.
11309841|NCT03154086|EG001|Reported Event|Part A: Cohort 1: GSK3352589 2 mg|Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
11309842|NCT03154086|EG002|Reported Event|Part A: Cohort 1: GSK3352589 5 mg|Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
11309843|NCT03154086|EG003|Reported Event|Part A: Cohort 1: GSK3352589 15 mg|Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
11309844|NCT03154086|EG004|Reported Event|Part A: Cohort 1: GSK3352589 50 mg|Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
11309845|NCT03154086|EG005|Reported Event|Part A: Cohort 2: Fasted Placebo|Participants received placebo tablet matching GSK3352589 without food in Period 1 of Cohort 2 in Part A of the study.
11309846|NCT03154086|EG006|Reported Event|Part A: Cohort 2: Fed Placebo|Participants received placebo tablet matching GSK3352589 with food in Period 2 of Cohort 2 in Part A of the study.
11309847|NCT03154086|EG007|Reported Event|Part A: Cohort 2: GSK3352589 Fed 25 mg|Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
11309848|NCT03154086|EG008|Reported Event|Part A: Cohort 2: GSK3352589 Fasted 25 mg|Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
11309849|NCT03154086|EG009|Reported Event|Part A: Cohort 3: Placebo|Participants received placebo tablet matching GSK3352589 in each Period of Cohort 3 in Part A of the study.
11309850|NCT03154086|EG010|Reported Event|Part A: Cohort 3: GSK3352589 150 mg|Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
11309851|NCT03154086|EG011|Reported Event|Part A: Cohort 3: GSK3352589 400 mg|Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
11309852|NCT03154086|EG012|Reported Event|Part B: Placebo BID|Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
11309853|NCT03154086|EG013|Reported Event|Part B: GSK3352589 5 mg BID|Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
11309854|NCT03154086|EG014|Reported Event|Part B: GSK3352589 15 mg BID|Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
11309855|NCT03154086|EG015|Reported Event|Part B: GSK3352589 50 mg BID|Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
11309856|NCT03154086|EG016|Reported Event|Part B: GSK3352589 100 mg BID|Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
11309857|NCT03154086|EG017|Reported Event|Part B: GSK3352589 200 mg BID|Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
11309858|NCT03154333|BG000|Baseline|Diacerein 1% Ointment|"diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered topically"
11309859|NCT03154333|BG001|Baseline|Vehicle Ointment|"vehicle ointment will be used for 8 weeks~vehicle ointment administered topically"
11309860|NCT03154333|BG002|Baseline|Total|Total of all reporting groups
11309861|NCT03154333|FG000|Participant Flow|Diacerein 1% Ointment|"diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered topically"
11309862|NCT03154333|FG001|Participant Flow|Vehicle Ointment|"vehicle ointment will be used for 8 weeks~vehicle ointment administered topically"
11309863|NCT03154333|OG000|Outcome|Diacerein 1% Ointment|"diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered topically"
11309864|NCT03154333|OG001|Outcome|Vehicle Ointment|"vehicle ointment will be used for 8 weeks~vehicle ointment administered topically"
11309865|NCT03154333|OG000|Outcome|Diacerein 1% Ointment|"diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered"
11309866|NCT03154333|EG000|Reported Event|Diacerein 1% Ointment|"diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered topically"
11309867|NCT03154333|EG001|Reported Event|Vehicle Ointment|"vehicle ointment will be used for 8 weeks~vehicle ointment administered topically"
11309868|NCT03154476|BG000|Baseline|Sildenafil|"Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.~Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months."
11309869|NCT03154476|BG001|Baseline|Placebo|"Subjects will receive placebo times per day for 12 months.~Placebo: Placebo capsules matching study drug"
11309870|NCT03154476|BG002|Baseline|Total|Total of all reporting groups
11309871|NCT03154476|FG000|Participant Flow|Sildenafil|"Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.~Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months."
11309872|NCT03154476|FG001|Participant Flow|Placebo|"Subjects will receive placebo times per day for 12 months.~Placebo: Placebo capsules matching study drug"
11309873|NCT03154476|OG000|Outcome|Sildenafil|"Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.~Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months."
11309874|NCT03154476|OG001|Outcome|Placebo|"Subjects will receive placebo times per day for 12 months.~Placebo: Placebo capsules matching study drug"
11309875|NCT03154476|EG000|Reported Event|Sildenafil|"Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.~Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months."
11309876|NCT03154476|EG001|Reported Event|Placebo|"Subjects will receive placebo times per day for 12 months.~Placebo: Placebo capsules matching study drug"
11309877|NCT03154658|BG000|Baseline|Sub-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309878|NCT03154658|BG001|Baseline|Supra-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309879|NCT03154658|BG002|Baseline|Total|Total of all reporting groups
11309880|NCT03154658|FG000|Participant Flow|Sub-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309881|NCT03154658|FG001|Participant Flow|Supra-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309882|NCT03154658|OG000|Outcome|Sub-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309883|NCT03154658|OG001|Outcome|Supra-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309884|NCT03154658|EG000|Reported Event|Sub-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309885|NCT03154658|EG001|Reported Event|Supra-serratus Regional Block|"A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.~Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast."
11309886|NCT03154710|BG000|Baseline|Web-application Follow up|"Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVCARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem~MOOVCARE: web-mediated follow up"
11309887|NCT03154710|BG001|Baseline|Standard|Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
11309888|NCT03154710|BG002|Baseline|Total|Total of all reporting groups
11309889|NCT03154710|FG000|Participant Flow|Web-application Follow up|"Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVCARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem~MOOVCARE: web-mediated follow up"
11309890|NCT03154710|FG001|Participant Flow|Standard|Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
11309891|NCT03154710|OG000|Outcome|Web-application Follow up|"Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVECARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem~MOOVECARE: web-mediated follow up"
11309892|NCT03154710|OG001|Outcome|Standard|Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
11309893|NCT03154710|EG000|Reported Event|Web-application Follow-up|"Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVECARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem~MOOVECARE: web-mediated follow up"
11309894|NCT03154710|EG001|Reported Event|Standard|Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)
11309895|NCT03155178|BG000|Baseline|3M CHG/IPA/Abdominal Region|Investigational CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
11309896|NCT03155178|BG001|Baseline|ChloraPrep/Abdominal Region|Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
11309897|NCT03155178|BG002|Baseline|3M CHG/IPA/Inguinal Region|Investigational CHG/IPA Prep randomly assigned to the left or right inguiinal region test sites
11309898|NCT03155178|BG003|Baseline|ChloraPrep/Inguinal Region|Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
11309899|NCT03155178|BG004|Baseline|Total|Total of all reporting groups
11309900|NCT03155178|FG000|Participant Flow|3M CHG/IPA Prep/Abdominal Region|Experimental CHG/IPA prep was randomly assigned to the left or right side of the abdominal test site
11309901|NCT03155178|FG001|Participant Flow|ChloraPrep/Abdominal Region|Active comparator CHG/IPA prep was randomly assigned to the left or right side of the abdominal test sites
11309902|NCT03155178|FG002|Participant Flow|3M CHG/IPA Prep/Inguinal Region|Experimental CHG/IPA prep was randomly assigned to the left or right side of the inguinal test site
11309903|NCT03155178|FG003|Participant Flow|ChloraPrep/Inguinal Region|Active comparator prep was randomly assigned to the left or right side of the inguinal test site
11309904|NCT03155178|OG000|Outcome|Experimental Prep - Abdominal Site|Following baseline sample collection participants had 3M CHG/IPA Prep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
11309905|NCT03155178|OG001|Outcome|Active Comparator Prep - Abdominal Site|Following baseline sample collection participants had ChloraPrep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
11309906|NCT03155178|OG002|Outcome|Experimental Prep - Inguinal Site|Following baseline sample collection participants had 3M CHG/IPA Prep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
11309907|NCT03155178|OG003|Outcome|Active Comparator Prep - Inguinal Site|Following baseline sample collection participants had ChloraPrep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
11309908|NCT03155178|OG000|Outcome|3M CHG/IPA Prep Abdominal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol 70% (IPA)
11309909|NCT03155178|OG001|Outcome|ChloraPrep CHG/IPA Abdominal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309910|NCT03155178|OG002|Outcome|3M CHG/IPA Prep Inguinal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309911|NCT03155178|OG003|Outcome|ChloraPrep CHG/IPA Inguinal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309912|NCT03155178|EG000|Reported Event|3M CHG/IPA Prep Abdominal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol 70% (IPA)
11309913|NCT03155178|EG001|Reported Event|ChloraPrep CHG/IPA Abdominal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309914|NCT03155178|EG002|Reported Event|3M CHG/IPA Prep Inguinal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309915|NCT03155178|EG003|Reported Event|ChloraPrep CHG/IPA Inguinal Region|Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
11309916|NCT03155269|BG000|Baseline|Test Product|Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309917|NCT03155269|BG001|Baseline|Reference Product|Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309918|NCT03155269|BG002|Baseline|Total|Total of all reporting groups
11309919|NCT03155269|FG000|Participant Flow|Test Product|Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309920|NCT03155269|FG001|Participant Flow|Reference Product|Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309921|NCT03155269|OG000|Outcome|Test Product|Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309922|NCT03155269|OG001|Outcome|Reference Product|Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309923|NCT03155269|EG000|Reported Event|Test Product|Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309924|NCT03155269|EG001|Reported Event|Reference Product|Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
11309925|NCT03155724|BG000|Baseline|MultiPole Pacing|"Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.~MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON."
11309926|NCT03155724|FG000|Participant Flow|MultiPole Pacing|"Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.~MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON."
11309927|NCT03155724|OG000|Outcome|MultiPole Pacing|"Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.~MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON."
11309928|NCT03155724|EG000|Reported Event|MultiPole Pacing|"Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.~MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON."
11309929|NCT03155945|BG000|Baseline|Olorinab 25 mg TID|Participants received olorinab 25 mg tablet by mouth, TID for 8 weeks
11309930|NCT03155945|BG001|Baseline|Olorinab 100 mg TID|Participants received olorinab 100 mg tablet by mouth, TID for 8 weeks
11309931|NCT03155945|BG002|Baseline|Total|Total of all reporting groups
11309932|NCT03155945|FG000|Participant Flow|Olorinab 25 mg TID|Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks
11309933|NCT03155945|FG001|Participant Flow|Olorinab 100 mg TID|Participants received olorinab 100 mg tablet by mouth, TID for 8 weeks
11309934|NCT03155945|OG000|Outcome|Olorinab 25 mg TID|Participants received olorinab 25 mg tablet by mouth, TID for 8 weeks
11309935|NCT03155945|OG001|Outcome|Olorinab 100 mg TID|Participants received olorinab 100 mg tablet by mouth, TID for 8 weeks
11309936|NCT03155945|EG000|Reported Event|Olorinab 25 mg TID|Participants received olorinab 25 milligrams (mg) oral tablets three times daily (TID) for 8 weeks
11309937|NCT03155945|EG001|Reported Event|Olorinab 100 mg TID|Participants received olorinab 100 mg oral tablets TID for 8 weeks
11309938|NCT03156270|BG000|Baseline|Subjects Followed Through 90 Days|Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
11309939|NCT03156270|FG000|Participant Flow|Vivaer Stylus Treatment|"Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area~Vivaer Stylus: Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area"
11309940|NCT03156270|OG000|Outcome|Subjects Followed Through 90 Days|Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
11309941|NCT03156270|OG000|Outcome|Subjects Followed Through 90 Days - Baseline Data|Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
11309942|NCT03156270|OG001|Outcome|Subjects Followed Through 90 Days - 90 Day Data|Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
11309943|NCT03156270|EG000|Reported Event|Subjects Followed Through 90 Days|Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
11309944|NCT03156543|BG000|Baseline|Jumpstart Dressing Pre-Operatively Only|"This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B~Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively"
11309945|NCT03156543|BG001|Baseline|Jumpstart Dressing Pre and Post-Operatively|"This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B"
11309946|NCT03156543|BG002|Baseline|Total|Total of all reporting groups
11309947|NCT03156543|FG000|Participant Flow|Jumpstart Dressing Pre-Operatively Only|"This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B~Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively"
11309948|NCT03156543|FG001|Participant Flow|Jumpstart Dressing Pre and Post-Operatively|"This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B"
11309949|NCT03156543|OG000|Outcome|Jumpstart Dressing Pre-Operatively Only|"This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B~Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively"
11333130|NCT03509675|EG001|Reported Event|Active Ingredient|"The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.~Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients."
11333131|NCT03509766|BG000|Baseline|Skin Testing|"All subject both allergic and non-allergic will be tested. There is only one (1) arm.~Histamine skin testing: skin testing using histamine"
11333132|NCT03509766|FG000|Participant Flow|Skin Testing|"All subjects both allergic and non-allergic will be tested. There is only one (1) arm.~Histamine skin testing: skin testing using histamine"
11333133|NCT03509766|OG000|Outcome|Skin Testing|"All subjects both allergic and non-allergic will be tested. There is only one (1) arm.~Histamine skin testing: skin testing using histamine"
11333134|NCT03509766|OG000|Outcome|1 Versus 6mg|1 versus 6mg histamine
11333135|NCT03509766|EG000|Reported Event|Adverse Events|no adverse events or reactions were reported. Events were recorded during the procedure and for 30 days following the procedure. Both serious and and non life threatening adverse vents were recorded.
11333136|NCT03509883|BG000|Baseline|Treatment A|Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)
11333137|NCT03509883|BG001|Baseline|Treatment B|Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)
11333138|NCT03509883|BG002|Baseline|Total|Total of all reporting groups
11333139|NCT03509883|FG000|Participant Flow|Treatment A, Then Treatment B|Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)
11333140|NCT03509883|FG001|Participant Flow|Treatment B, Then Treatment A|Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)
11333141|NCT03509883|OG000|Outcome|Treatment A|Apixaban tablets (treatment A)
11333142|NCT03509883|OG001|Outcome|Treatment B|Apixaban sprinkle capsules (treatment B)
11333143|NCT03509883|OG000|Outcome|Treatment B|Sprinkle Capsules as compared to tablet formulation
11309950|NCT03156543|OG001|Outcome|Jumpstart Dressing Pre and Post-Operatively|"This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B"
11309951|NCT03156543|EG000|Reported Event|Jumpstart Dressing Pre-Operatively Only|"This group will have the jumpstart dressing pre-operatively and a standard dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B~Standard Dressing: This is a standard of care bandage that will be placed on participants in group A post operatively"
11309952|NCT03156543|EG001|Reported Event|Jumpstart Dressing Pre and Post-Operatively|"This group will have the jumpstart dressing pre-operatively and a jumpstart dressing post operatively.~Jumpstart Dressing: JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.~It will be applied pre-op in all patients and post operatively in group B"
11309953|NCT03156621|BG000|Baseline|Placebo in DBTP|Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309954|NCT03156621|BG001|Baseline|Alirocumab 150 mg SC Q2W|Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309955|NCT03156621|BG002|Baseline|Total|Total of all reporting groups
11309956|NCT03156621|FG000|Participant Flow|Placebo in DBTP|Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309957|NCT03156621|FG001|Participant Flow|Alirocumab 150 mg SC Q2W|Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309958|NCT03156621|OG000|Outcome|Placebo in DBTP|Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309959|NCT03156621|OG001|Outcome|Alirocumab 150 mg SC Q2W|Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309960|NCT03156621|OG002|Outcome|Alirocumab 150 mg SC Q2W in OLTP|Participants who received at least 1 dose or part of a dose of open-label investigational study drug alirocumab in OLTP
11309961|NCT03156621|EG000|Reported Event|DB Placebo (DBTP)|Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period.
11309962|NCT03156621|EG001|Reported Event|DB Alirocumab 150 Q2W (DBTP)|Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period.
11309963|NCT03156621|EG002|Reported Event|DB Placebo (OLTP)|Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309964|NCT03156621|EG003|Reported Event|DB Alirocumab 150 Q2W (OLTP)|Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W
11309965|NCT03157089|BG000|Baseline|Afatinib 40 mg + Pembrolizumab 200 mg|"40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11333144|NCT03509883|EG000|Reported Event|Treatment A|Apixaban tablets 5 × 0.5-mg
11333145|NCT03509883|EG001|Reported Event|Treatment B|Apixaban sprinkle capsules (treatment B)
11309966|NCT03157089|BG001|Baseline|Afatinib 30 mg + Pembrolizumab 200 mg|"30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309967|NCT03157089|BG002|Baseline|Total|Total of all reporting groups
11309968|NCT03157089|FG000|Participant Flow|Afatinib 40 mg + Pembrolizumab 200 mg|"40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309969|NCT03157089|FG001|Participant Flow|Afatinib 30 mg + Pembrolizumab 200 mg|"30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309970|NCT03157089|OG000|Outcome|Afatinib 40 mg + Pembrolizumab 200 mg|"40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309971|NCT03157089|OG001|Outcome|Afatinib 30 mg + Pembrolizumab 200 mg|"30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309972|NCT03157089|OG000|Outcome|Afatinib + Pembrolizumab|"Comprises both arms during the safety run-in part. 30 or 40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309973|NCT03157089|EG000|Reported Event|Afatinib 40 mg + Pembrolizumab 200 mg|"40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309974|NCT03157089|EG001|Reported Event|Afatinib 30 mg + Pembrolizumab 200 mg|"30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles."
11309975|NCT03157232|BG000|Baseline|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
11309976|NCT03157232|FG000|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
11309977|NCT03157232|OG000|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
11309978|NCT03157232|EG000|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
11309979|NCT03157531|BG000|Baseline|B-Laser™ Atherectomy System|"B-Laser™ Atherectomy System~B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses"
11309980|NCT03157531|FG000|Participant Flow|B-Laser™ Atherectomy System|"B-Laser™ Atherectomy System~B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses"
11309981|NCT03157531|OG000|Outcome|B-Laser™ Atherectomy System|"B-Laser™ Atherectomy System~B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses"
11309982|NCT03157531|EG000|Reported Event|B-Laser™ Atherectomy System|"B-Laser™ Atherectomy System~B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses"
11309983|NCT03157583|BG000|Baseline|All Participants|Included all the participants who randomized to receive the study product.
11309984|NCT03157583|FG000|Participant Flow|All Participants|All the participants randomized to the study. In this study, there were a total of 7 test sites assigned to each participant. One test site was used for provisional MEDu (Minimal Erythemal Dose of Unprotected Skin) measurement, on the remaining 6 sites test products (4) and the positive control product (P3 standard) were applied and 1 site was left unprotected.
11309985|NCT03157583|OG000|Outcome|Test Product 1|This arm included all the test sites on the participants back where test product 1 was applied for SPF testing.
11309986|NCT03157583|OG001|Outcome|Test Product 2|This arm included all the test sites on the participants back where test product 2 was applied for SPF testing.
11309987|NCT03157583|OG002|Outcome|Test Product 3|This arm included all the test sites on the participants back where test product 3 was applied for SPF testing.
11309988|NCT03157583|OG003|Outcome|Test Product 4|This arm included all the test sites on the participants back where test product 4 was applied for SPF testing.
11309989|NCT03157583|OG004|Outcome|Reference Product (for SPFi Calculation)|This arm included all the test sites on the participants back where reference product (P3 standard sunscreen) was applied.
11309990|NCT03157583|OG000|Outcome|Test Product 1|This arm included all the test plates used for UVAPF testing and test sites on the participants back where test product 1 was applied for SPF testing.
11309991|NCT03157583|OG001|Outcome|Test Product 2|This arm included all the test plates used for UVAPF testing and test sites on the participants back where test product 2 was applied for SPF testing.
11309992|NCT03157583|OG002|Outcome|Test Product 3|This arm included all the test plates used for UVAPF testing and test sites on the participants back where test product 3 was applied for SPF testing.
11309993|NCT03157583|OG003|Outcome|Test Product 4|This arm included all the test plates used for UVAPF testing and test sites on the participants back where test product 4 was applied for SPF testing.
11309994|NCT03157583|OG004|Outcome|Reference (for UVAPFi and SPFi Calculation)|This arm included test plates treated with reference sunscreen formulation S2. Also includes all the test sites on the participants back where reference product (P3 standard sunscreen) was applied.
11309995|NCT03157583|EG000|Reported Event|Reference Product (for SPFi Calculation)|This arm included all the test sites on the participants back where reference product (P3 standard sunscreen) was applied.
11309996|NCT03157583|EG001|Reported Event|Negative Control (for SPFi Calculation)|This arm included all the test sites on the participants back which were left unprotected.
11309997|NCT03157583|EG002|Reported Event|Test Product 1|This arm included all the test sites on the participants back where test product 1 was applied for SPF testing.
11309998|NCT03157583|EG003|Reported Event|Test Product 2|This arm included all the test sites on the participants back where test product 2 was applied for SPF testing.
11309999|NCT03157583|EG004|Reported Event|Test Product 3|This arm included all the test sites on the participants back where test product 3 was applied for SPF testing.
11310000|NCT03157583|EG005|Reported Event|Test Product 4|This arm included all the test sites on the participants back where test product 4 was applied for SPF testing.
11310001|NCT03158012|BG000|Baseline|Active Treatment|Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients
11310002|NCT03158012|BG001|Baseline|Placebo Treatment|Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
11310003|NCT03158012|BG002|Baseline|Total|Total of all reporting groups
11310004|NCT03158012|FG000|Participant Flow|Active Treatment|Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients
11310005|NCT03158012|FG001|Participant Flow|Placebo Treatment|Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
11310006|NCT03158012|OG000|Outcome|Active Treatment|Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients
11310007|NCT03158012|OG001|Outcome|Placebo Treatment|Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
11310008|NCT03158012|EG000|Reported Event|Active Treatment|Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients
11310009|NCT03158012|EG001|Reported Event|Placebo Treatment|Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
11310010|NCT03158038|BG000|Baseline|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1.
11310011|NCT03158038|BG001|Baseline|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11310012|NCT03158038|BG002|Baseline|Total|Total of all reporting groups
11310013|NCT03158038|FG000|Participant Flow|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1.
11310014|NCT03158038|FG001|Participant Flow|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11310015|NCT03158038|OG000|Outcome|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
11310016|NCT03158038|OG001|Outcome|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11310017|NCT03158038|EG000|Reported Event|Monovalent Influenza Vaccine|Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1.
11310018|NCT03158038|EG001|Reported Event|Placebo|Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
11310019|NCT03158116|BG000|Baseline|Treatment|"All participants will be receiving the study drug~Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties"
11310020|NCT03158116|FG000|Participant Flow|Treatment|"All participants will be receiving the study drug~Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties"
11310021|NCT03158116|OG000|Outcome|Treatment|"All participants will be receiving the study drug~Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties"
11310022|NCT03158116|EG000|Reported Event|Treatment|"All participants will be receiving the study drug~Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties"
11310023|NCT03158220|BG000|Baseline|Women 16-26 Years of Age|Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310024|NCT03158220|BG001|Baseline|Women 27-45 Years of Age|Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310025|NCT03158220|BG002|Baseline|Total|Total of all reporting groups
11310026|NCT03158220|FG000|Participant Flow|Women 16-26 Years of Age|Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310027|NCT03158220|FG001|Participant Flow|Women 27-45 Years of Age|Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310028|NCT03158220|OG000|Outcome|Women 16-26 Years of Age|Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310029|NCT03158220|OG001|Outcome|Women 27-45 Years of Age|Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310030|NCT03158220|EG000|Reported Event|Women 16-26 Years of Age|Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310031|NCT03158220|EG001|Reported Event|Women 27-45 Years of Age|Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
11310032|NCT03158272|BG000|Baseline|M1 Cohort|2 mg/kg cabiralizumab monotherapy
11310033|NCT03158272|BG001|Baseline|M2 Cohort|4 mg/kg cabiralizumab monotherapy
11310034|NCT03158272|BG002|Baseline|C1 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
11310035|NCT03158272|BG003|Baseline|C2 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
11310036|NCT03158272|BG004|Baseline|Total|Total of all reporting groups
11310037|NCT03158272|FG000|Participant Flow|M1 Cohort|2 mg/kg cabiralizumab monotherapy
11310038|NCT03158272|FG001|Participant Flow|M2 Cohort|4 mg/kg cabiralizumab monotherapy
11310039|NCT03158272|FG002|Participant Flow|C1 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
11310040|NCT03158272|FG003|Participant Flow|C2 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
11310041|NCT03158272|OG000|Outcome|M1 Cohort|2 mg/kg cabiralizumab monotherapy
11310042|NCT03158272|OG001|Outcome|M2 Cohort|4 mg/kg cabiralizumab monotherapy
11310043|NCT03158272|OG000|Outcome|C1 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
11310044|NCT03158272|OG001|Outcome|C2 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
11310045|NCT03158272|OG002|Outcome|C1 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
11310046|NCT03158272|OG003|Outcome|C2 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
11310047|NCT03158272|EG000|Reported Event|M1 Cohort|2 mg/kg cabiralizumab monotherap
11310048|NCT03158272|EG001|Reported Event|M2 Cohort|4 mg/kg cabiralizumab monotherapy
11310049|NCT03158272|EG002|Reported Event|C1 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
11310050|NCT03158272|EG003|Reported Event|C2 Cohort|Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
11310051|NCT03158311|BG000|Baseline|QVM149 150/50/80 μg|QVM149 150/50/80 μg o.d. delivered via Concept1
11310052|NCT03158311|BG001|Baseline|QVM149 150/50/160 μg|QVM149 150/50/160 μg o.d. delivered via Concept1
11310053|NCT03158311|BG002|Baseline|Salmeterol/Fluticasone 50/500 μg Plus Tiotropium 5 μg|Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
11310054|NCT03158311|BG003|Baseline|Total|Total of all reporting groups
11310055|NCT03158311|FG000|Participant Flow|QVM149 150/50/80 μg|QVM149 150/50/80 μg o.d. delivered via Concept1
11310056|NCT03158311|FG001|Participant Flow|QVM149 150/50/160 μg|QVM149 150/50/160 μg o.d. delivered via Concept1
11310057|NCT03158311|FG002|Participant Flow|Salmeterol/Fluticasone 50/500 μg Plus Tiotropium 5 μg|Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
11310058|NCT03158311|OG000|Outcome|QVM149 150/50/80 μg|QVM149 150/50/80 μg o.d. delivered via Concept1
11310059|NCT03158311|OG001|Outcome|QVM149 150/50/160 μg|QVM149 150/50/160 μg o.d. delivered via Concept1
11310060|NCT03158311|OG002|Outcome|Salmeterol/Fluticasone 50/500 μg Plus Tiotropium 5 μg|Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
11310061|NCT03158311|EG000|Reported Event|QVM149 150/50/80 μg|QVM149 150/50/80 µg o.d. delivered via Concept1
11310062|NCT03158311|EG001|Reported Event|QVM149 150/50/160 µg|QVM149 150/50/160 μg o.d. delivered via Concept1
11310063|NCT03158311|EG002|Reported Event|Salmeterol/Fluticasone 50/500 μg Plus Tiotropium 5 μg|Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
11310064|NCT03158714|BG000|Baseline|Couples Connecting Mindfully Curriculum|"Receives the Couples Connecting Mindfully curriculum over a 6 week period.~Couples Connecting Mindfully"
11310065|NCT03158714|BG001|Baseline|ELEVATE Curriculum|"Receives the ELEVATE curriculum over a 6 week period.~ELEVATE"
11310066|NCT03158714|BG002|Baseline|Control|No programming is offered.
11310067|NCT03158714|BG003|Baseline|Total|Total of all reporting groups
11310068|NCT03158714|FG000|Participant Flow|Couples Connecting Mindfully Curriculum|"Receives the Couples Connecting Mindfully curriculum over a 6 week period.~Couples Connecting Mindfully"
11310069|NCT03158714|FG001|Participant Flow|ELEVATE Curriculum|"Receives the ELEVATE curriculum over a 6 week period.~ELEVATE"
11310070|NCT03158714|FG002|Participant Flow|Control|No programming is offered.
11310071|NCT03158714|OG000|Outcome|Couples Connecting Mindfully Curriculum|"Receives the Couples Connecting Mindfully curriculum over a 6 week period.~Couples Connecting Mindfully"
11310072|NCT03158714|OG001|Outcome|ELEVATE Curriculum|"Receives the ELEVATE curriculum over a 6 week period.~ELEVATE"
11310073|NCT03158714|OG002|Outcome|Control|No programming is offered.
11310074|NCT03158714|EG000|Reported Event|Couples Connecting Mindfully Curriculum|"Receives the Couples Connecting Mindfully curriculum over a 6 week period.~Couples Connecting Mindfully"
11310075|NCT03158714|EG001|Reported Event|ELEVATE Curriculum|"Receives the ELEVATE curriculum over a 6 week period.~ELEVATE"
11310076|NCT03158714|EG002|Reported Event|Control|No programming is offered.
11310077|NCT03159091|BG000|Baseline|Rengalin|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Rengalin: Oral administration."
11310078|NCT03159091|BG001|Baseline|Placebo|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Placebo: Oral administration."
11310079|NCT03159091|BG002|Baseline|Total|Total of all reporting groups
11310080|NCT03159091|FG000|Participant Flow|Rengalin|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Rengalin: Oral administration."
11310081|NCT03159091|FG001|Participant Flow|Placebo|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Placebo: Oral administration."
11310082|NCT03159091|OG000|Outcome|Rengalin|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Rengalin: Oral administration."
11310083|NCT03159091|OG001|Outcome|Placebo|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Placebo: Oral administration."
11310084|NCT03159091|EG000|Reported Event|Rengalin|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Rengalin: Oral administration."
11310085|NCT03159091|EG001|Reported Event|Placebo|"Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).~Placebo: Oral administration."
11310086|NCT03159143|BG000|Baseline|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
11310087|NCT03159143|FG000|Participant Flow|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
11310088|NCT03159143|OG000|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
11310089|NCT03159143|EG000|Reported Event|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.~Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.~Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
11310090|NCT03159260|BG000|Baseline|Theraworx|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310091|NCT03159260|BG001|Baseline|Placebo|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310092|NCT03159260|BG002|Baseline|Total|Total of all reporting groups
11310093|NCT03159260|FG000|Participant Flow|Theraworx|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310094|NCT03159260|FG001|Participant Flow|Placebo|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310095|NCT03159260|OG000|Outcome|Theraworx|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310096|NCT03159260|OG001|Outcome|Placebo|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310097|NCT03159260|EG000|Reported Event|Theraworx|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310098|NCT03159260|EG001|Reported Event|Placebo|"Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/[pH]uel (treatment) and the other contained a physiologically inert substance (placebo control).~Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm."
11310099|NCT03159299|BG000|Baseline|Yo Puedo|"This group will receive the modified Yo Puedo + mHealth program.~Yo Puedo + mHealth: This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months."
11310100|NCT03159299|BG001|Baseline|Wait-list Control|This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished.
11310101|NCT03159299|BG002|Baseline|Total|Total of all reporting groups
11310102|NCT03159299|FG000|Participant Flow|Yo Puedo|"This group will receive the modified Yo Puedo + mHealth program.~Yo Puedo + mHealth: This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months."
11310103|NCT03159299|FG001|Participant Flow|Wait-list Control|This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished.
11310104|NCT03159299|OG000|Outcome|Yo Puedo|"This group will receive the modified Yo Puedo + mHealth program.~Yo Puedo + mHealth: This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months."
11310105|NCT03159299|OG001|Outcome|Wait-list Control|This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished.
11310106|NCT03159299|EG000|Reported Event|Yo Puedo|"This group will receive the modified Yo Puedo + mHealth program.~Yo Puedo + mHealth: This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months."
11310107|NCT03159299|EG001|Reported Event|Wait-list Control|This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished.
11310108|NCT03159455|BG000|Baseline|Placebo (Japanese)|Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
11310109|NCT03159455|BG001|Baseline|BI 1467335 3 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310110|NCT03159455|BG002|Baseline|BI 1467335 6 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310111|NCT03159455|BG003|Baseline|BI 1467335 10 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310112|NCT03159455|BG004|Baseline|Placebo (Caucasian)|Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
11310113|NCT03159455|BG005|Baseline|BI 1467335 10 mg Tablet (Caucasian)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
11310114|NCT03159455|BG006|Baseline|Total|Total of all reporting groups
11310115|NCT03159455|FG000|Participant Flow|Placebo (Japanese)|Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
11310116|NCT03159455|FG001|Participant Flow|BI 1467335 3 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310117|NCT03159455|FG002|Participant Flow|BI 1467335 6 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310118|NCT03159455|FG003|Participant Flow|BI 1467335 10 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310119|NCT03159455|FG004|Participant Flow|Placebo (Caucasian)|Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
11310120|NCT03159455|FG005|Participant Flow|BI 1467335 10 mg Tablet (Caucasian)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
11310121|NCT03159455|OG000|Outcome|Placebo (Japanese)|Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
11310122|NCT03159455|OG001|Outcome|BI 1467335 3 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310123|NCT03159455|OG002|Outcome|BI 1467335 6 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310124|NCT03159455|OG003|Outcome|BI 1467335 10 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310125|NCT03159455|OG004|Outcome|Placebo (Caucasian)|Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
11310126|NCT03159455|OG005|Outcome|BI 1467335 10 mg Tablet (Caucasian)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
11310127|NCT03159455|OG000|Outcome|BI 1467335 3 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310128|NCT03159455|OG001|Outcome|BI 1467335 6 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310129|NCT03159455|OG002|Outcome|BI 1467335 10 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310130|NCT03159455|OG003|Outcome|BI 1467335 10 mg Tablet (Caucasian)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
11310131|NCT03159455|EG000|Reported Event|Placebo (Japanese)|Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
11310132|NCT03159455|EG001|Reported Event|BI 1467335 3 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310133|NCT03159455|EG002|Reported Event|BI 1467335 6 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310134|NCT03159455|EG003|Reported Event|BI 1467335 10 mg Tablet (Japanese)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
11310135|NCT03159455|EG004|Reported Event|Placebo (Caucasian)|Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
11310136|NCT03159455|EG005|Reported Event|BI 1467335 10 mg Tablet (Caucasian)|Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
11310137|NCT03159468|BG000|Baseline|Cognitive Restructuring & Alcohol Condition|"Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310138|NCT03159468|BG001|Baseline|Mindfulness & Alcohol Condition|"Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310139|NCT03159468|BG002|Baseline|Nutrition Information & Alcohol Condition|Participants received general information about nutrition, then received an alcoholic beverage in the lab.
11310140|NCT03159468|BG003|Baseline|Cognitive Restructuring & No Alcohol Condition|"Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310141|NCT03159468|BG004|Baseline|Mindfulness & No Alcohol Condition|"Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310142|NCT03159468|BG005|Baseline|Nutrition Information & No Alcohol Condition|Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.
11310143|NCT03159468|BG006|Baseline|Total|Total of all reporting groups
11310144|NCT03159468|FG000|Participant Flow|Cognitive Restructuring & Alcohol Condition|"Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume an alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310145|NCT03159468|FG001|Participant Flow|Mindfulness & Alcohol Condition|"Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310146|NCT03159468|FG002|Participant Flow|Nutrition Information & Alcohol Condition|Participants receive general information about nutrition, then receive an alcoholic beverage in the lab.
11310147|NCT03159468|FG003|Participant Flow|Cognitive Restructuring & No Alcohol Condition|"Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume a non-alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310148|NCT03159468|FG004|Participant Flow|Mindfulness & No Alcohol Condition|"Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310149|NCT03159468|FG005|Participant Flow|Nutrition Information & No Alcohol Condition|Participants receive general information about nutrition, then receive a non-alcoholic beverage in the lab.
11310150|NCT03159468|OG000|Outcome|Cognitive Restructuring & Alcohol Condition|"Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310151|NCT03159468|OG001|Outcome|Mindfulness & Alcohol Condition|"Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310152|NCT03159468|OG002|Outcome|Nutrition Information & Alcohol Condition|Participants received general information about nutrition, then received an alcoholic beverage in the lab.
11310153|NCT03159468|OG003|Outcome|Cognitive Restructuring & No Alcohol Condition|"Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310154|NCT03159468|OG004|Outcome|Mindfulness & No Alcohol Condition|"Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310155|NCT03159468|OG005|Outcome|Nutrition Information & No Alcohol Condition|Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.
11310156|NCT03159468|EG000|Reported Event|Cognitive Restructuring & Alcohol Condition|"Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive an alcoholic beverage.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310157|NCT03159468|EG001|Reported Event|Mindfulness & Alcohol Condition|"Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310158|NCT03159468|EG002|Reported Event|Nutrition Information & Alcohol Condition|Participants will receive general information about nutrition, then receive an alcoholic beverage.
11310159|NCT03159468|EG003|Reported Event|Cognitive Restrucuring & No Alcohol Condition|"Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive a non-alcoholic beverage.~Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations."
11310160|NCT03159468|EG004|Reported Event|Mindfulness & No Alcohol Condition|"Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage.~Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations."
11310161|NCT03159468|EG005|Reported Event|Nutrition Information & No Alcohol Condition|Participants will receive general information about nutrition, then receive a non-alcoholic beverage.
11310162|NCT03159611|BG000|Baseline|Tenoten for Children|"Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310163|NCT03159611|BG001|Baseline|Placebo|"Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310164|NCT03159611|BG002|Baseline|Total|Total of all reporting groups
11310165|NCT03159611|FG000|Participant Flow|Placebo|"Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310166|NCT03159611|FG001|Participant Flow|Tenoten for Children|"Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310167|NCT03159611|OG000|Outcome|Tenoten for Children|"Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310168|NCT03159611|OG001|Outcome|Placebo|"Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310169|NCT03159611|EG000|Reported Event|Tenoten for Children|"Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310170|NCT03159611|EG001|Reported Event|Placebo|"Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.~The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use."
11310171|NCT03159624|BG000|Baseline|Treatment Group|"2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone~Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft~Doyle silastic sheet: Doyle silastic sheet"
11310172|NCT03159624|BG001|Baseline|Control Group|"Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone~Doyle silastic sheet: Doyle silastic sheet"
11310173|NCT03159624|BG002|Baseline|Total|Total of all reporting groups
11310174|NCT03159624|FG000|Participant Flow|Treatment Group|"2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone~Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft~Doyle silastic sheet: Doyle silastic sheet"
11310175|NCT03159624|FG001|Participant Flow|Control Group|"Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone~Doyle silastic sheet: Doyle silastic sheet"
11310176|NCT03159624|OG000|Outcome|Treatment Group|"2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone~Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft~Doyle silastic sheet: Doyle silastic sheet"
11310177|NCT03159624|OG001|Outcome|Control Group|"Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone~Doyle silastic sheet: Doyle silastic sheet"
11310178|NCT03159624|EG000|Reported Event|Treatment Group|"2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone~Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft~Doyle silastic sheet: Doyle silastic sheet"
11310179|NCT03159624|EG001|Reported Event|Control Group|"Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone~Doyle silastic sheet: Doyle silastic sheet"
11310180|NCT03160027|BG000|Baseline|Immediate PBM Treatment - Patient|"This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.~Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment."
11310181|NCT03160027|BG001|Baseline|Immediate PBM Treatment - Study Partner|This arm will help administer photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks to the patient.
11310182|NCT03160027|BG002|Baseline|Delayed PBM Treatment - Patient|This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.
11310183|NCT03160027|BG003|Baseline|Delayed PBM Treatment - Study Partner|This arm will maintain usual activities for 12 weeks.
11310184|NCT03160027|BG004|Baseline|Total|Total of all reporting groups
11310185|NCT03160027|FG000|Participant Flow|Immediate PBM Treatment - Patients|"This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.~Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment."
11310186|NCT03160027|FG001|Participant Flow|Delayed PBM Treatment - Patients|This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.
11310187|NCT03160027|FG002|Participant Flow|Immediate PBM Treatment - Caregivers|This arm consists of the caregivers of patients who will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes.
11310188|NCT03160027|FG003|Participant Flow|Delayed PBM Treatment - Caregivers|This arm consists of caregivers of patients who will maintain usual activities for 12 weeks.
11310189|NCT03160027|OG000|Outcome|Immediate PBM Treatment|"This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.~Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment."
11310190|NCT03160027|OG001|Outcome|Delayed PBM Treatment|This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.
11310191|NCT03160027|OG002|Outcome|Delayed PBM After 12 Weeks of PBM|Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
11310192|NCT03160027|OG002|Outcome|Delayed PBM After 12 Weeks of PBM|Delayed PBM patients who opted to undergo 12 weeks of
11310193|NCT03160027|OG002|Outcome|Delayed PBM After 12 Weeks of PBM|Delayed PBM participants who chose to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
11310194|NCT03160027|OG002|Outcome|Delayed PBM After 12 Weeks of PBM|Delayed PBM participants who opted to undergo 12 weeks fo PBM treatments after 12 weeks of Usual Care
11310195|NCT03160027|EG000|Reported Event|Immediate PBM Treatment|"This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.~Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment."
11310196|NCT03160027|EG001|Reported Event|Delayed PBM Treatment|This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.
11310197|NCT03160027|EG002|Reported Event|Delayed PBM Participants Who Underwent PBM Treatment After|This arm consists of Delayed PBM participants who opt to undergo 12 weeks of PBM treatments after maintaining usual activities for 12 weeks. After the Week 12 psychometric and MRI assessments, participants arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.
11310198|NCT03160170|BG000|Baseline|Use of Cobb Device|"Use of SISTER device during surgery~SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery"
11310199|NCT03160170|BG001|Baseline|Control|Standard exposure technique and instruments will be used during surgery
11310200|NCT03160170|BG002|Baseline|Total|Total of all reporting groups
11310201|NCT03160170|FG000|Participant Flow|Use of Cobb Device|"Use of SISTER device during surgery~SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery"
11310202|NCT03160170|FG001|Participant Flow|Control|Standard exposure technique and instruments will be used during surgery
11310203|NCT03160170|OG000|Outcome|Use of Cobb Device|"Use of SISTER device during surgery~SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery"
11310204|NCT03160170|OG001|Outcome|Control|Standard exposure technique and instruments will be used during surgery
11310205|NCT03160170|EG000|Reported Event|Use of Cobb Device|"Use of SISTER device during surgery~SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery"
11310206|NCT03160170|EG001|Reported Event|Control|Standard exposure technique and instruments will be used during surgery
11310207|NCT03160287|BG000|Baseline|Motivational Interview and Text Messages|"Multidimensional, tailored intervention for sleep deficiency in for older adults with OA~Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA"
11310208|NCT03160287|FG000|Participant Flow|Motivational Interview and Text Messages|"Multidimensional, tailored intervention for sleep deficiency in for older adults with OA~Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA"
11310209|NCT03160287|OG000|Outcome|Motivational Interview and Text Messages|"Multidimensional, tailored intervention for sleep deficiency in for older adults with OA~Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA"
11310210|NCT03160287|EG000|Reported Event|Motivational Interview and Text Messages|"Multidimensional, tailored intervention for sleep deficiency in for older adults with OA~Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA"
11310211|NCT03160560|BG000|Baseline|Test-Unflavored Rinse, Then Placebo|Participants received ClōSYS® Unflavored Rinse, Then Placebo Unflavored Rinse
11310212|NCT03160560|BG001|Baseline|Test-Flavored Rinse, Then Placebo|Subjects received ClōSYS® Flavored Rinse, Then Placebo Flavored Rinse.
11310213|NCT03160560|BG002|Baseline|Placebo, Then Flavored Rinse|Subjects in Placebo group received Placebo Rinse, then ClōSYS® Flavored Rinse
11310214|NCT03160560|BG003|Baseline|Placebo, Then Unflavored Rinse|Subjects in Placebo group received Placebo Rinse, then ClōSYS® Unflavored Rinse.
11310215|NCT03160560|BG004|Baseline|Total|Total of all reporting groups
11310216|NCT03160560|FG000|Participant Flow|Test-Unflavored Rinse, Then Placebo|Participants received ClōSYS® Unflavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
11310217|NCT03160560|FG001|Participant Flow|Test-Flavored Rinse, Then Placebo|Participants received ClōSYS® Flavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
11310218|NCT03160560|FG002|Participant Flow|Placebo, Then Flavored Rinse|Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Flavored Rinse rinse for use for 3 weeks.
10972088|NCT00919503|BG001|Baseline|Regimen B (UBCT)|"CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 .~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD.~Anti-Thymocyte Globulin: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo total body irradiation~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV"
11310219|NCT03160560|FG003|Participant Flow|Placebo, Then Unflavored Rinse|Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Unflavored Rinse rinse for use for 3 weeks.
11310220|NCT03160560|OG000|Outcome|Unflavored Rinse, Then Placebo|"CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.~ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse, then Placebo."
11310221|NCT03160560|OG001|Outcome|Flavored Rinse, Then Placebo|"CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring.~ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse, then Placebo"
11310222|NCT03160560|OG002|Outcome|Placebo Flavored, Then Flavored Rinse|"CloSYS Oral Rinse product (no chlorine dioxide)~Placebo: Subjects in Placebo group will receive Placebo Rinse, then Flavored CloSYS Oral Rinse."
11310223|NCT03160560|OG003|Outcome|Placebo Unflavored, Then Unflavored Rinse|"CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.~ClōSYS® Unflavored Rinse: Subjects in Test group will receive Placebo, then ClōSYS® Unflavored Rinse."
11310224|NCT03160560|EG000|Reported Event|Test-Unflavored Rinse|ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse
11310225|NCT03160560|EG001|Reported Event|Test-Flavored Rinse|ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse
11310226|NCT03160560|EG002|Reported Event|Placebo Flavored Rinse|Placebo: Subjects in Placebo group will receive Placebo Rinse.
11310227|NCT03160560|EG003|Reported Event|Placebo Unflavored Rinse|Placebo: Subjects in Placebo group will receive Placebo Rinse
11310228|NCT03160573|BG000|Baseline|Test-Unflavored Rinse Then Placebo Unflavored Rinse|"CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide."
11310229|NCT03160573|BG001|Baseline|Test-Flavored Rinse Then Placebo Flavored Rinse|"CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide."
11310230|NCT03160573|BG002|Baseline|Flavored Oral Rinse-Placebo Then Test-Flavored Rinse|"CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide~Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution."
11310231|NCT03160573|BG003|Baseline|Unflavored Oral Rinse-Placebo Then Unflavored Oral Rinse|"CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide~Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse then CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution."
11310232|NCT03160573|BG004|Baseline|Total|Total of all reporting groups
11310233|NCT03160573|FG000|Participant Flow|Test-Unflavored Rinse Then Placebo-Unflavored Rinse|"CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then Placebo-Unflavored rinse"
11310234|NCT03160573|FG001|Participant Flow|Test-Flavored Rinse Then Placebo-Flavored Rinse|"CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then Placebo Flavored Rinse"
10972089|NCT00919503|BG002|Baseline|Total|Total of all reporting groups
11310235|NCT03160573|FG002|Participant Flow|Flavored Oral Rinse-Placebo Then Test-Flavored Rinse|"CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide~Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then CloSYS mint flavored rinse containing 0.1% stabilized chlorine dioxide"
11310236|NCT03160573|FG003|Participant Flow|Unflavored Oral Rinse-Placebo Then Test-Unflavored Oral Rinse|"CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide~Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse then CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide"
11310237|NCT03160573|OG000|Outcome|Test-Unflavored Rinse Then Placebo Unflavored Rinse|"CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then Placebo Unflavored rinse"
11310238|NCT03160573|OG001|Outcome|Test-Flavored Rinse Then Placebo Flavored Rinse|"CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then Placebo Flavored Rinse"
11310239|NCT03160573|OG002|Outcome|Flavored Oral Rinse-Placebo Then Test Flavored Oral Rinse|"CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide~Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then Test Flavored Oral Rinse"
11310240|NCT03160573|OG003|Outcome|Unflavored Oral Rinse-Placebo Then Test Unflavored Oral Rinse|"CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide~Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse"
11310241|NCT03160573|EG000|Reported Event|Test-Unflavored Rinse|"CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse"
11310242|NCT03160573|EG001|Reported Event|Test-Flavored Rinse|"CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution~ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse"
11310243|NCT03160573|EG002|Reported Event|Flavored Oral Rinse-Placebo|"CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide~Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse"
11310244|NCT03160573|EG003|Reported Event|Unflavored Oral Rinse-Placebo|"CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide~Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse"
11310245|NCT03160703|BG000|Baseline|Test Dentifrice 1 (RDA~58)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
11310246|NCT03160703|BG001|Baseline|Test Dentifrice 2 (RDA~77)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
11310247|NCT03160703|BG002|Baseline|Reference Dentifrice 1 (RDA~80)|Participants applied dentifrice containing 1000 ppm fluoride as SMFP
11310248|NCT03160703|BG003|Baseline|Reference Dentifrice 2 (RDA~120)|Participants applied dentifrice containing 0.454% SnF2
11310249|NCT03160703|BG004|Baseline|Total|Total of all reporting groups
11310250|NCT03160703|FG000|Participant Flow|Test Dentifrice 1 (RDA~58)|Participants applied experimental dentifrice containing 0.454 percent (%) stannous fluoride (SnF2) / 5% sodium tripolyphosphate (STP); 2.0% abrasive silica
11310251|NCT03160703|FG001|Participant Flow|Test Dentifrice 2 (RDA~77)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
11310252|NCT03160703|FG002|Participant Flow|Reference Dentifrice 1 (RDA~80)|Participants applied dentifrice containing 1000 parts per million (ppm) fluoride as Sodium Monofluorophosphate (SMFP)
11310253|NCT03160703|FG003|Participant Flow|Reference Dentifrice 2 (RDA~120)|Participants applied dentifrice containing 0.454% SnF2
11310254|NCT03160703|OG000|Outcome|Test Dentifrice 1 (RDA~58)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
11310255|NCT03160703|OG001|Outcome|Test Dentifrice 2 (RDA~77)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
11310256|NCT03160703|OG002|Outcome|Reference Dentifrice 1 (RDA~80)|Participants applied dentifrice containing 1000 ppm fluoride as SMFP
11310257|NCT03160703|OG003|Outcome|Reference Dentifrice 2 (RDA~120)|Participants applied dentifrice containing 0.454% SnF2
11310258|NCT03160703|EG000|Reported Event|Test Dentifrice 1 (RDA~58)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
11310259|NCT03160703|EG001|Reported Event|Test Dentifrice 2 (RDA~77)|Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
11310260|NCT03160703|EG002|Reported Event|Reference Dentifrice 1 (RDA~80)|Participants applied dentifrice containing 1000 ppm fluoride as SMFP
11310261|NCT03160703|EG003|Reported Event|Reference Dentifrice 2 (RDA~120)|Participants applied dentifrice containing 0.454% SnF2
11310262|NCT03160716|BG000|Baseline|Treatment|Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
11310263|NCT03160716|FG000|Participant Flow|Treatment|Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
11310264|NCT03160716|OG000|Outcome|Treatment|Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
11310265|NCT03160716|EG000|Reported Event|Treatment|Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
11310266|NCT03160885|BG000|Baseline|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab"
11310267|NCT03160885|BG001|Baseline|Initial Treatment Period - Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo"
11310268|NCT03160885|BG002|Baseline|Total|Total of all reporting groups
11310269|NCT03160885|FG000|Participant Flow|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab"
11310270|NCT03160885|FG001|Participant Flow|Initial Treatment Period - Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo"
11310271|NCT03160885|FG002|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab."
11310272|NCT03160885|FG003|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11310273|NCT03160885|FG004|Participant Flow|Maintenance Treatment Period - Placebo Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11310274|NCT03160885|FG005|Participant Flow|Maintenance Treatment Period -Placebo Q2W - Tralokinumab Naive|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11310275|NCT03160885|FG006|Participant Flow|Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS|"Week 16 to Week 52:~Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if~IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR~IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR~Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA>1 at Week 16~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg"
11310276|NCT03160885|OG000|Outcome|Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab"
11310277|NCT03160885|OG001|Outcome|Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo"
11310278|NCT03160885|OG000|Outcome|Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen~At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab."
11310279|NCT03160885|OG001|Outcome|Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen~At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo."
11310280|NCT03160885|OG002|Outcome|Placebo Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen~At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo."
11310281|NCT03160885|OG000|Outcome|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab"
11310282|NCT03160885|OG001|Outcome|Initial Treatment Period - Placebo Q2W|"Week 0 to Week 16:~Placebo Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo"
11310283|NCT03160885|EG000|Reported Event|Initial Period - Tralokinumab Q2W|Initial Period - Tralokinumab Q2W (n=592, patient years of exposure (PYE)=176.90)
11310284|NCT03160885|EG001|Reported Event|Initial Period - Placebo|Initial Period - Placebo (n=200, PYE=57.35)
11310285|NCT03160885|EG002|Reported Event|Maintenance Period - Tralokinumab Q2W|Maintenance Period - Tralokinumab Q2W (n=91, PYE=46.93)
11310286|NCT03160885|EG003|Reported Event|Maintenance Period - Tralokinumab Q4W|Maintenance Period - Tralokinumab Q4W (n=89, PYE=44.65)
11310287|NCT03160885|EG004|Reported Event|Maintenance Period - Placebo|Maintenance Period - Placebo (n=46, PYE=20.07)
11310288|NCT03160885|EG005|Reported Event|Maintenance Period - Placebo - Tralokinumab Naive|Maintenance Period - Placebo - Tralokinumab Naive (n=31, PYE=15.09)
11310289|NCT03160885|EG006|Reported Event|Open-label Period - Tralokinumab Q2W + Optional TCS|Open-label Period - Tralokinumab Q2W + Optional TCS (n=558, PYE=315.48)
11310290|NCT03160885|EG007|Reported Event|Safety Follow-up|"Safety Follow-up (n=641, PYE=142.90) includes subjects from Initial, Maintenance and Open-label Periods:~Tralokinumab Q2W (n=83); Tralokinumab Q4W (n=50); Tralokinumab Q2W + optional TCS (n=454); Placebo (n=54)"
11310291|NCT03160898|BG000|Baseline|Placebo|Patients in this group received placebo twice daily for 12 weeks
11310292|NCT03160898|BG001|Baseline|Reldesemtiv 150 mg Twice Daily|Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
11310293|NCT03160898|BG002|Baseline|Reldesemtiv 300 mg Twice Daily|Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
11310294|NCT03160898|BG003|Baseline|Reldesemtiv 450 mg Twice Daily|Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
11310295|NCT03160898|BG004|Baseline|Total|Total of all reporting groups
11310296|NCT03160898|FG000|Participant Flow|Placebo|Patients in this group received placebo twice daily for 12 weeks
11310297|NCT03160898|FG001|Participant Flow|Reldesemtiv 150 mg Twice Daily|Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
11310298|NCT03160898|FG002|Participant Flow|Reldesemtiv 300 mg Twice Daily|Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
11310299|NCT03160898|FG003|Participant Flow|Reldesemtiv 450 mg Twice Daily|Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
11310300|NCT03160898|OG000|Outcome|Placebo|Patients in this group received placebo twice daily for 12 weeks
11310301|NCT03160898|OG001|Outcome|Reldesemtiv 150 mg Twice Daily|Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
11310302|NCT03160898|OG002|Outcome|Reldesemtiv 300 mg Twice Daily|Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
11310303|NCT03160898|OG003|Outcome|Reldesemtiv 450 mg Twice Daily|Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
11310304|NCT03160898|OG004|Outcome|Reldesemtiv 300 mg & 450 mg|For analysis purposes, the results from the reldesemtiv 300 mg group and the 450 mg group were pooled.
11310305|NCT03160898|EG000|Reported Event|Placebo|Patients in this group received placebo twice daily for 12 weeks
11310306|NCT03160898|EG001|Reported Event|Reldesemtiv 150 mg Twice Daily|Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
11310307|NCT03160898|EG002|Reported Event|Reldesemtiv 300 mg Twice Daily|Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
11310308|NCT03160898|EG003|Reported Event|Reldesemtiv 450 mg Twice Daily|Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
11310309|NCT03161158|BG000|Baseline|Ultrafiltration Group|"Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.~CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days."
11310310|NCT03161158|BG001|Baseline|Control Group (Usual Care IV Diuretics)|"Guideline-directed therapy including IV loop diuretics according to treatment algorithm.~Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)"
11310311|NCT03161158|BG002|Baseline|Total|Total of all reporting groups
11310312|NCT03161158|FG000|Participant Flow|Ultrafiltration Group|"Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.~CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days."
11310313|NCT03161158|FG001|Participant Flow|Control Group (Usual Care IV Diuretics)|"Guideline-directed therapy including IV loop diuretics according to treatment algorithm.~Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)"
11310314|NCT03161158|OG000|Outcome|Ultrafiltration Group|"Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.~CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days."
11310315|NCT03161158|OG001|Outcome|Control Group (Usual Care IV Diuretics)|"Guideline-directed therapy including IV loop diuretics according to treatment algorithm.~Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)"
11310316|NCT03161158|EG000|Reported Event|Ultrafiltration Group|"Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.~CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days."
11310317|NCT03161158|EG001|Reported Event|Control Group (Usual Care IV Diuretics)|"Guideline-directed therapy including IV loop diuretics according to treatment algorithm.~Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)"
11310318|NCT03161327|BG000|Baseline|Patients at Risk for PAD|For those who screened positive by the questionnaire, and signed consent, a digital ABI was performed using QuantaFlo™. For subjects with PAD the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. For subjects with no evidence of PAD, subject will be informed of results, and no further action taken.
11310319|NCT03161327|FG000|Participant Flow|Patients at Risk for PAD|For those who screened positive by the questionnaire, and signed consent, a digital ABI was performed using QuantaFlo™. For subjects with PAD the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. For subjects with no evidence of PAD, subject will be informed of results, and no further action taken.
11310320|NCT03161327|OG000|Outcome|ABI Severe Risk|Those who screened at risk for PAD on questionnaire, had digital ABI performed, and if ABI <0.4 , these were described as severe risk for PAD
11310321|NCT03161327|OG001|Outcome|ABI Moderate-mild Risk|Those who screened at risk for PAD on questionnaire, had digital ABI performed, and results were 0.4 to 0.9 , these were at moderate or mild risk for PAD
11310322|NCT03161327|EG000|Reported Event|ABIABI Using QuantaFlo™|"ABI will be performed in patient~ABI using QuantaFlo™: Perform Digital ABI:~Will be performed by the nurse/medical assistant with training to perform this test~The patient will be placed in the supine position, with the arms and legs at the same level as the heart, for a minimum of 5 minutes before measurement.~The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the hands and feet: Right and left hand fingers and then right and left feet toes.~Usually each digit takes about 15 seconds to obtain a waveform~At the end of 60 seconds, an automated digital ABI will be generated.~Clinical course: If based on Screening questionnaire and digital ABI, I. Patient is diagnosed with PAD- the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic.~II. There is no evidence of PAD- no further action will be taken. The patient will be informed"
11310323|NCT03161405|BG000|Baseline|TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg|TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
11310324|NCT03161405|FG000|Participant Flow|TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg|TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
11310325|NCT03161405|OG000|Outcome|TAK-906 Maleate 25 mg|TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
11310326|NCT03161405|OG001|Outcome|Itraconazole 200 mg + TAK-906 Maleate 25 mg|Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
11310327|NCT03161405|EG000|Reported Event|TAK-906 Maleate 25 mg|TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
10822271|NCT00075725|FG000|Participant Flow|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11310328|NCT03161405|EG001|Reported Event|Itraconazole 200 mg|Itraconazole 200 mg, solution, orally, once daily on Days 1 to 3 of Second Intervention Period.
11310329|NCT03161405|EG002|Reported Event|Itraconazole 200 mg + TAK-906 Maleate 25 mg|Itraconazole 200 mg, solution, orally, once daily on Days 4 and 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
11310330|NCT03161483|BG000|Baseline|PBO QD|Placebo-matching treatment once a day
11310331|NCT03161483|BG001|Baseline|0.15 mg QD|Participants dosed with CC-220 at 0.15 mg once a day
11310332|NCT03161483|BG002|Baseline|0.30 mg QD|Participants dosed with CC-220 at 0.30 mg once a day
11310333|NCT03161483|BG003|Baseline|0.45 mg QD|Participants dosed with CC-220 at 0.45 mg once a day
11310334|NCT03161483|BG004|Baseline|Total|Total of all reporting groups
11310335|NCT03161483|FG000|Participant Flow|PBO QD|Placebo-matching treatment once a day
11310336|NCT03161483|FG001|Participant Flow|0.15 mg QD|Participants dosed with CC-220 at 0.15 mg once a day
11310337|NCT03161483|FG002|Participant Flow|0.30 mg QD|Participants dosed with CC-220 at 0.30 mg once a day
11310338|NCT03161483|FG003|Participant Flow|0.45 mg QD|Participants dosed with CC-220 at 0.45 mg once a day
11310339|NCT03161483|OG000|Outcome|PBO QD|Placebo-matching treatment once a day
11310340|NCT03161483|OG001|Outcome|0.15 mg QD|Participants dosed with CC-220 at 0.15 mg once a day
11310341|NCT03161483|OG002|Outcome|0.30 mg QD|Participants dosed with CC-220 at 0.30 mg once a day
11310342|NCT03161483|OG003|Outcome|0.45 mg QD|Participants dosed with CC-220 at 0.45 mg once a day
11310343|NCT03161483|EG000|Reported Event|PBO Controlled - PBO|Placebo-matching treatment once a day
11310344|NCT03161483|EG001|Reported Event|PBO Controlled - 0.15 mg QD|Participants dosed with CC-220 at 0.15 mg once a day
11310345|NCT03161483|EG002|Reported Event|PBO Controlled - 0.30 mg QD|Participants dosed with CC-220 at 0.30 mg once a day
11310346|NCT03161483|EG003|Reported Event|PBO Controlled - 0.45 mg QD|Participants dosed with CC-220 at 0.45 mg once a day
10972090|NCT00919503|FG000|Participant Flow|Regimen A (PBSCT and BMT)|"CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1.~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~Allogeneic Bone Marrow Transplantation: Infused IV~Anti-Thymocyte Globulin: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Peripheral Blood Stem Cell Transplantation: Infused IV~Tacrolimus: Given IV or PO~Treosulfan: Given IV"
10972091|NCT00919503|FG001|Participant Flow|Regimen B (UBCT)|"CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 .~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD.~Anti-Thymocyte Globulin: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo total body irradiation~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV"
11310347|NCT03161938|BG000|Baseline|Dexamethasone 48 mg|"Dexamethasone 48 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310348|NCT03161938|BG001|Baseline|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310349|NCT03161938|BG002|Baseline|Total|Total of all reporting groups
11310350|NCT03161938|FG000|Participant Flow|Dexamethasone 48 mg|"Dexamethasone 48 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310351|NCT03161938|FG001|Participant Flow|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310352|NCT03161938|OG000|Outcome|Dexamethasone 48 mg|"Dexamethasone 48 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310353|NCT03161938|OG001|Outcome|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310354|NCT03161938|EG000|Reported Event|Dexamethasone 48 mg|"Dexamethasone 48 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310355|NCT03161938|EG001|Reported Event|Dexamethasone 8 mg|"Dexamethasone 8 mg pre-operative, single shot injection~Dexamethasone: intravenous"
11310356|NCT03162055|BG000|Baseline|Glycopyrronium/Formoterol Fumarate|Participants were randomized to receive 2 inhalations of GFF fixed-dose combination 7.2/4.8 mcg per actuation administered in the morning and evening by MDI for 24 weeks. Participants also received 1 inhalation of placebo matched to UV administered once daily in the morning by DPI for 24 weeks.
11310357|NCT03162055|BG001|Baseline|Umeclidinium/Vilanterol|Participants were randomized to receive 1 inhalation of UV fixed-dose combination 62.5/25 mcg per actuation administered once daily in the morning by DPI for 24 weeks. Participants also received 2 inhalations of placebo matched to the GFF administered twice daily in the morning and evening by MDI for 24 weeks.
11310358|NCT03162055|BG002|Baseline|Total|Total of all reporting groups
11310359|NCT03162055|FG000|Participant Flow|Glycopyrronium/Formoterol Fumarate|Participants were randomized to receive 2 inhalations of glycopyrronium/formoterol fumarate (GFF) fixed-dose combination 7.2/4.8 micrograms (mcg) per actuation administered in the morning and evening by metered dose inhaler (MDI) for 24 weeks. Participants also received 1 inhalation of placebo matched to umeclidinium/vilanterol (UV) administered once daily in the morning by dry powder inhaler (DPI) for 24 weeks.
11310360|NCT03162055|FG001|Participant Flow|Umeclidinium/Vilanterol|Participants were randomized to receive 1 inhalation of UV fixed-dose combination 62.5/25 mcg per actuation administered once daily in the morning by DPI for 24 weeks. Participants also received 2 inhalations of placebo matched to the GFF administered twice daily in the morning and evening by MDI for 24 weeks.
11310361|NCT03162055|OG000|Outcome|Glycopyrronium/Formoterol Fumarate|Participants were randomized to receive 2 inhalations of GFF fixed-dose combination 7.2/4.8 mcg per actuation administered in the morning and evening by MDI for 24 weeks. Participants also received 1 inhalation of placebo matched to UV administered once daily in the morning by DPI for 24 weeks.
11310362|NCT03162055|OG001|Outcome|Umeclidinium/Vilanterol|Participants were randomized to receive 1 inhalation of UV fixed-dose combination 62.5/25 mcg per actuation administered once daily in the morning by DPI for 24 weeks. Participants also received 2 inhalations of placebo matched to the GFF administered twice daily in the morning and evening by MDI for 24 weeks.
11310363|NCT03162055|EG000|Reported Event|Glycopyrronium/Formoterol Fumarate|Participants were randomized to receive 2 inhalations of GFF fixed-dose combination 7.2/4.8 mcg per actuation administered in the morning and evening by MDI for 24 weeks. Participants also received 1 inhalation of placebo matched to UV administered once daily in the morning by DPI for 24 weeks.
11310364|NCT03162055|EG001|Reported Event|Umeclidinium/Vilanterol|Participants were randomized to receive 1 inhalation of UV fixed-dose combination 62.5/25 mcg per actuation administered once daily in the morning by DPI for 24 weeks. Participants also received 2 inhalations of placebo matched to the GFF administered twice daily in the morning and evening by MDI for 24 weeks.
11310365|NCT03162328|BG000|Baseline|Screening Population|All patients that signed consent are considered for the screening population.
11310366|NCT03162328|FG000|Participant Flow|Screening Population|All patients that signed consent are considered for the screening population.
11310367|NCT03162328|FG001|Participant Flow|Powersleep Sham, PowerSleep Stim|"Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. After 2 nights in the lab in the sham condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers."
11310368|NCT03162328|FG002|Participant Flow|Powersleep Stim, PowerSleep Sham|"Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. After 2 nights in the lab in the stim condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.~PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers."
11310369|NCT03162328|OG000|Outcome|Powersleep Sham|PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
11310370|NCT03162328|OG001|Outcome|PowerSleep Stim|PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
11310371|NCT03162328|OG001|Outcome|Powersleep Stim|Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
11310372|NCT03162328|OG001|Outcome|Powersleep Stim|Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. After 2 nights in the lab in the stim condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
11310373|NCT03162328|OG000|Outcome|Powersleep Sham|All participants who wore the PowerSleep deice in the sham condition for at least one night.
11310374|NCT03162328|OG001|Outcome|PowerSleep Stim|All Participants who wore the PowerSleep device in the Stim condition.
11310375|NCT03162328|EG000|Reported Event|Screening Period|All Study participants that were consented to the study.
11310376|NCT03162328|EG001|Reported Event|PowerSleep Sham, PowerSleep Stim|"Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. After 2 nights in the lab in the sham condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers."
11310377|NCT03162328|EG002|Reported Event|Powersleep Stim, PowerSleep Sham|"Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. After 2 nights in the lab in the stim condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.~PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.~PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers."
11310378|NCT03162354|BG000|Baseline|Intervention Sites|"At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly booster training emails, access to an AHT probability calculator, audit and site-specific feedback, and local information sharing sessions designed to address local barriers to CDR acceptance and application.~Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool: The Clinical Decision Rule (CDR) for AHT reads as follows:~Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered high risk and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture."
11310379|NCT03162354|BG001|Baseline|Control Sites|"At the four matched control sites, physicians will engage in AHT screening as usual."
11310380|NCT03162354|BG002|Baseline|Total|Total of all reporting groups
11310381|NCT03162354|FG000|Participant Flow|Intervention Sites|"At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly booster training emails, access to an AHT probability calculator, audit and site-specific feedback, and local information sharing sessions designed to address local barriers to CDR acceptance and application.~Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool: The Clinical Decision Rule (CDR) for AHT reads as follows:~Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered high risk and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture."
11310382|NCT03162354|FG001|Participant Flow|Control Sites|"At the four matched control sites, physicians will engage in AHT screening as usual."
11310383|NCT03162354|OG000|Outcome|Intervention Sites|"At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly booster training emails, access to an AHT probability calculator, audit and site-specific feedback, and local information sharing sessions designed to address local barriers to CDR acceptance and application.~Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool: The Clinical Decision Rule (CDR) for AHT reads as follows:~Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered high risk and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture."
11310384|NCT03162354|OG001|Outcome|Control Sites|"At the four matched control sites, physicians will engage in AHT screening as usual."
11310385|NCT03162354|OG000|Outcome|Intervention Sites at Baseline|Equivalent, eligible, young, acutely head-injured patients hospitalized for intensive care at one of the same four intervention sites during prior PediBIRN studies, conducted between 2010 and 2013.
11310386|NCT03162354|OG001|Outcome|Intervention Sites During the Cluster Randomized Trial|"At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly booster training emails, access to an AHT probability calculator, audit and site-specific feedback, and local information sharing sessions designed to address local barriers to CDR acceptance and application."
11310387|NCT03162354|OG000|Outcome|All Eight Participating Sites|The four intervention sites and four control sites
11310388|NCT03162354|OG000|Outcome|Intervention Sites|At the same four intervention sites, during prior (strictly observational) PediBIRN studies conducted to derive and validate the PediBIRN 4-variable clinical decision rule.
11310389|NCT03162354|OG001|Outcome|Control Sites|At the same four control sites, during prior (strictly observational) PediBIRN studies conducted to derive and validate the PediBIRN 4-variable clinical decision rule.
11310390|NCT03162354|EG000|Reported Event|Intervention Sites|"At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly booster training emails, access to an AHT probability calculator, audit and site-specific feedback, and local information sharing sessions designed to address local barriers to CDR acceptance and application.~Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool: The Clinical Decision Rule (CDR) for AHT reads as follows:~Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered high risk and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture."
11310391|NCT03162354|EG001|Reported Event|Control Sites|"At the four matched control sites, physicians will engage in AHT screening as usual."
11310392|NCT03162458|BG000|Baseline|Anaferon for Children|Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310393|NCT03162458|BG001|Baseline|Placebo|Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310394|NCT03162458|BG002|Baseline|Total|Total of all reporting groups
11310395|NCT03162458|FG000|Participant Flow|Anaferon for Children|Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310396|NCT03162458|FG001|Participant Flow|Placebo|Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310397|NCT03162458|OG000|Outcome|Anaferon for Children|Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310398|NCT03162458|OG001|Outcome|Placebo|Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310399|NCT03162458|EG000|Reported Event|Anaferon for Children|Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310400|NCT03162458|EG001|Reported Event|Placebo|Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
11310401|NCT03162614|BG000|Baseline|AduFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
11310402|NCT03162614|BG001|Baseline|2PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
11310403|NCT03162614|BG002|Baseline|PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
11310404|NCT03162614|BG003|Baseline|Adu2Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
11310405|NCT03162614|BG004|Baseline|Adu1Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
11310406|NCT03162614|BG005|Baseline|Control Group|Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
11310407|NCT03162614|BG006|Baseline|Total|Total of all reporting groups
11310408|NCT03162614|FG000|Participant Flow|AduFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
11310409|NCT03162614|FG001|Participant Flow|2PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
11310410|NCT03162614|FG002|Participant Flow|PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
11310411|NCT03162614|FG003|Participant Flow|Adu2Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
11310412|NCT03162614|FG004|Participant Flow|Adu1Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
11310413|NCT03162614|FG005|Participant Flow|Control Group|Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
11310414|NCT03162614|OG000|Outcome|AduFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
11310415|NCT03162614|OG001|Outcome|2PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
11310416|NCT03162614|OG002|Outcome|PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
11310417|NCT03162614|OG003|Outcome|Adu2Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
11310418|NCT03162614|OG004|Outcome|Adu1Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
11310419|NCT03162614|OG005|Outcome|Control Group|Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
11310420|NCT03162614|EG000|Reported Event|AduFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
11310421|NCT03162614|EG001|Reported Event|2PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
11310422|NCT03162614|EG002|Reported Event|PedFx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
11310423|NCT03162614|EG003|Reported Event|Adu2Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
11310424|NCT03162614|EG004|Reported Event|Adu1Fx Group|Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
11310425|NCT03162614|EG005|Reported Event|Control Group|Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
11310426|NCT03162796|BG000|Baseline|Placebo|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
11310427|NCT03162796|BG001|Baseline|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
11310428|NCT03162796|BG002|Baseline|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
11310429|NCT03162796|BG003|Baseline|Total|Total of all reporting groups
11310430|NCT03162796|FG000|Participant Flow|Placebo|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
11310431|NCT03162796|FG001|Participant Flow|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
11310432|NCT03162796|FG002|Participant Flow|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
11310433|NCT03162796|OG000|Outcome|Placebo|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 48 in the active treatment period.
11310434|NCT03162796|OG001|Outcome|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
11310435|NCT03162796|OG002|Outcome|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
11310436|NCT03162796|OG000|Outcome|Guselkumab 100 mg q8w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) and placebo matched to guselkumab injections at other visits through Week 48.
11310437|NCT03162796|OG001|Outcome|Guselkumab 100 mg q4w|Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 48.
11310438|NCT03162796|EG000|Reported Event|Placebo (CP)|Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP). Data prior to the first administration of guselkumab, or through the last follow-up visit if the participant did not receive any guselkumab, were included.
11310439|NCT03162796|EG001|Reported Event|Guselkumab 100 mg q8w (CP)|Participants received guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.
11310440|NCT03162796|EG002|Reported Event|Guselkumab 100 mg q4w (CP)|Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through Week 20 in the placebo controlled period (CP). Data through Week 24, or through the last follow-up visit if the participant did not receive any study drug at or after Week 24, were included.
11310441|NCT03162796|EG003|Reported Event|Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)|Participants who received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (CP) received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 24 through Week 48. Data from the first administration of guselkumab through Week 60 were included.
11310442|NCT03162796|EG004|Reported Event|Guselkumab 100 mg q8w (Through Week 60)|Participants received guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks and placebo matched to guselkumab injections at other visits through Week 48. Data from Week 0 through Week 60 were included.
11310443|NCT03162796|EG005|Reported Event|Guselkumab 100 mg q4w (Through Week 60)|Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through Week 48. Data from Week 0 through Week 60 were included.
11310444|NCT03163017|BG000|Baseline|2D Fluoroscopy Then 3D Fluoroscopy|"Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system."
11310445|NCT03163017|FG000|Participant Flow|2D Fluoroscopy Then 3D Fluoroscopy|"Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system."
11310446|NCT03163017|OG000|Outcome|2D Fluoroscopy Then 3D Fluoroscopy|"Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system."
11310447|NCT03163017|EG000|Reported Event|2D Fluoroscopy Then 3D Fluoroscopy|"Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system."
11310448|NCT03163134|BG000|Baseline|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
11310449|NCT03163134|BG001|Baseline|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.~Lumbar Drain"
11310450|NCT03163134|BG002|Baseline|Total|Total of all reporting groups
11310451|NCT03163134|FG000|Participant Flow|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
11310452|NCT03163134|FG001|Participant Flow|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery~Lumbar Drain"
11310453|NCT03163134|OG000|Outcome|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
11310454|NCT03163134|OG001|Outcome|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.~Lumbar Drain"
11310455|NCT03163134|EG000|Reported Event|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
11310456|NCT03163134|EG001|Reported Event|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery~Lumbar Drain"
11310457|NCT03163303|BG000|Baseline|Tobacco Status Project + Alcohol Intervention|"Tobacco and alcohol intervention on Facebook and 14-day nicotine patch~Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use~nicotine patch: 14-day supply of nicotine patch"
11310458|NCT03163303|BG001|Baseline|Tobacco Status Project Intervention|"Tobacco intervention on Facebook and 14-day nicotine patch~Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use~nicotine patch: 14-day supply of nicotine patch"
11310459|NCT03163303|BG002|Baseline|Total|Total of all reporting groups
11310460|NCT03163303|FG000|Participant Flow|Tobacco Status Project + Alcohol Intervention|"Tobacco and alcohol intervention on Facebook and 14-day nicotine patch~Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use~nicotine patch: 14-day supply of nicotine patch"
11310461|NCT03163303|FG001|Participant Flow|Tobacco Status Project Intervention|"Tobacco intervention on Facebook and 14-day nicotine patch~Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use~nicotine patch: 14-day supply of nicotine patch"
11310462|NCT03163303|OG000|Outcome|Tobacco Status Project + Alcohol Intervention|"Tobacco and alcohol intervention on Facebook and 14-day nicotine patch~Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use~nicotine patch: 14-day supply of nicotine patch"
11310463|NCT03163303|OG001|Outcome|Tobacco Status Project Intervention|"Tobacco intervention on Facebook and 14-day nicotine patch~Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use~nicotine patch: 14-day supply of nicotine patch"
11310464|NCT03163303|EG000|Reported Event|Tobacco Status Project + Alcohol Intervention|"Tobacco and alcohol intervention on Facebook and 14-day nicotine patch~Tobacco Status Project + Alcohol Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use~nicotine patch: 14-day supply of nicotine patch"
11310465|NCT03163303|EG001|Reported Event|Tobacco Status Project Intervention|"Tobacco intervention on Facebook and 14-day nicotine patch~Tobacco Status Project Intervention: 90 days of Facebook messaging, weekly live sessions targeting tobacco use~nicotine patch: 14-day supply of nicotine patch"
11310466|NCT03163342|BG000|Baseline|Open Label|"Licensed seasonal influenza vaccine, intramuscular~Licensed seasonal influenza vaccine: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine"
11310467|NCT03163342|FG000|Participant Flow|Open Label|"Licensed seasonal influenza vaccine, intramuscular~Licensed seasonal influenza vaccine: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine"
11310468|NCT03163342|OG000|Outcome|FluZone|Open label
11310469|NCT03163342|EG000|Reported Event|FluZone|Open label
11310470|NCT03163446|BG000|Baseline|CF-301|Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310471|NCT03163446|BG001|Baseline|Placebo|Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310472|NCT03163446|BG002|Baseline|Total|Total of all reporting groups
11310473|NCT03163446|FG000|Participant Flow|CF-301|Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310474|NCT03163446|FG001|Participant Flow|Placebo|Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310475|NCT03163446|OG000|Outcome|CF-301|Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310476|NCT03163446|OG001|Outcome|Placebo|Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310477|NCT03163446|OG000|Outcome|MRSA - CF-301|Patients in the MRSA Subgroup that received CF-301
11310478|NCT03163446|OG001|Outcome|MRSA - Placebo|Patients in the MRSA Subgroup that received Placebo
11310479|NCT03163446|OG000|Outcome|cBSI/R-IE - CF-301|Patients with cBSI/R-IE that received CF-301
11310480|NCT03163446|OG001|Outcome|cBSI/R-IE - Placebo|Patients with cBSI/R-IE that received Placebo
11310481|NCT03163446|OG000|Outcome|MRSA, US - CF-301|Patients enrolled in the United States (discharged alive) in the MRSA Subgroup that received CF-301
11310482|NCT03163446|OG001|Outcome|MRSA, US - Placebo|Patients enrolled in the United States (discharged alive) in the MRSA Subgroup that received Placebo
11310483|NCT03163446|EG000|Reported Event|CF-301|Patients received a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310484|NCT03163446|EG001|Reported Event|Placebo|Patients received a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
11310485|NCT03163472|BG000|Baseline|10 ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine."
11310486|NCT03163472|BG001|Baseline|30ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine."
11310487|NCT03163472|BG002|Baseline|Total|Total of all reporting groups
11310488|NCT03163472|FG000|Participant Flow|10ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine."
11310489|NCT03163472|FG001|Participant Flow|30ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine."
11310490|NCT03163472|OG000|Outcome|10 ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine."
11310491|NCT03163472|OG001|Outcome|30ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine."
11310492|NCT03163472|OG000|Outcome|10ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine."
11310493|NCT03163472|OG001|Outcome|30ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine."
11310494|NCT03163472|EG000|Reported Event|10ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine."
11310495|NCT03163472|EG001|Reported Event|30ml of Lidocaine 2% With Epinephrine|"patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine."
11310496|NCT03163758|BG000|Baseline|rTMS Treatment Group|"The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~real Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity."
11310497|NCT03163758|BG001|Baseline|Sham Group|"The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~sham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp."
11310498|NCT03163758|BG002|Baseline|Total|Total of all reporting groups
11310499|NCT03163758|FG000|Participant Flow|rTMS Treatment Group|"The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~real Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity."
11310500|NCT03163758|FG001|Participant Flow|Sham Group|"The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~sham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp."
11310501|NCT03163758|OG000|Outcome|rTMS Treatment Group|"The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~real Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity."
11310502|NCT03163758|OG001|Outcome|Sham Group|"The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~sham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp."
11310503|NCT03163758|EG000|Reported Event|rTMS Treatment Group|"The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~real Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity."
11310504|NCT03163758|EG001|Reported Event|Sham Group|"The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.~sham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp."
11310505|NCT03164538|BG000|Baseline|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11310506|NCT03164538|BG001|Baseline|Diabetes Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).~Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments."
11310507|NCT03164538|BG002|Baseline|Total|Total of all reporting groups
11310508|NCT03164538|FG000|Participant Flow|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11310509|NCT03164538|FG001|Participant Flow|Diabetes Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).~Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments."
11310510|NCT03164538|OG000|Outcome|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11310511|NCT03164538|OG001|Outcome|Diabetes Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).~Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments."
11310512|NCT03164538|EG000|Reported Event|Positive Psychology + Motivational Interviewing|"Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.~Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions."
11310513|NCT03164538|EG001|Reported Event|Diabetes Education|"Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).~Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments."
11310514|NCT03164551|BG000|Baseline|GERI+ Incubator|The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310515|NCT03164551|BG001|Baseline|Conventional Incubator|The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310516|NCT03164551|BG002|Baseline|Total|Total of all reporting groups
11310517|NCT03164551|FG000|Participant Flow|GERI+ Incubator|The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310518|NCT03164551|FG001|Participant Flow|Conventional Incubator|The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310519|NCT03164551|OG000|Outcome|GERI+ Incubator|The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310520|NCT03164551|OG001|Outcome|Conventional Incubator|The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310521|NCT03164551|EG000|Reported Event|GERI+ Incubator|The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310522|NCT03164551|EG001|Reported Event|Conventional Incubator|The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
11310523|NCT03164629|BG000|Baseline|3D Angiogram + Emboguide|Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
11310524|NCT03164629|BG001|Baseline|No 3D Angiogram + Emboguide|Embolization will be guided by a standard of care CT.
11310525|NCT03164629|BG002|Baseline|Total|Total of all reporting groups
11310526|NCT03164629|FG000|Participant Flow|3D Angiogram + Emboguide|"The following parameters will be recorded for the study group:~Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels."
11310527|NCT03164629|FG001|Participant Flow|No 3D Angiogram + Emboguide|Embolization will be guided by a standard of care CT.
11310528|NCT03164629|OG000|Outcome|3D Angiogram + Emboguide|Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
11310529|NCT03164629|OG001|Outcome|No 3D Angiogram + Emboguide|Embolization will be guided by a standard of care CT.
11310530|NCT03164629|EG000|Reported Event|3D Angiogram + Emboguide|articipants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
11310531|NCT03164629|EG001|Reported Event|No 3D Angiogram + Emboguide|Embolization will be guided by a standard of care CT.
11310532|NCT03165045|BG000|Baseline|Spiolto® Respimat® at Study Start|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
11310533|NCT03165045|FG000|Participant Flow|Spiolto® Respimat®|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
11310534|NCT03165045|OG000|Outcome|Spiolto® Respimat|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
11310535|NCT03165045|OG000|Outcome|Spiolto® Respimat® at Study Start|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
11310536|NCT03165045|OG001|Outcome|Spiolto® Respimat® Final Vist|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
11310537|NCT03165045|EG000|Reported Event|Total|Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
11310538|NCT03165058|BG000|Baseline|Inflammatory Bowel Disease|"Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310539|NCT03165058|BG001|Baseline|Control|"Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310540|NCT03165058|BG002|Baseline|Total|Total of all reporting groups
11310541|NCT03165058|FG000|Participant Flow|Inflammatory Bowel Disease|"Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310542|NCT03165058|FG001|Participant Flow|Control|"Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11333146|NCT03509948|BG000|Baseline|All Study Participants|"3 mg Cytisine, Schedule A: Fed Then Fasted~Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~3 mg Cytisine, Schedule B: Fasted Then Fed~Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)."
11310543|NCT03165058|OG000|Outcome|Inflammatory Bowel Disease|"Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310544|NCT03165058|OG001|Outcome|Control|"Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310545|NCT03165058|EG000|Reported Event|Inflammatory Bowel Disease|"Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310546|NCT03165058|EG001|Reported Event|Control|"Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.~mucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research."
11310547|NCT03165110|BG000|Baseline|Users of the Onyx Blood Glucose Meter/ App System at Home|"All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App."
11310548|NCT03165110|FG000|Participant Flow|Users of the Onyx Blood Glucose Meter/ App System at Home|"All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App."
11310549|NCT03165110|OG000|Outcome|Users of the Onyx Blood Glucose Meter/ App System at Home|"All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App."
11310550|NCT03165110|EG000|Reported Event|Users of the Onyx Blood Glucose Meter/ App System at Home|"All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management.~Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App."
11310551|NCT03165175|BG000|Baseline|App + Treatment as Usual|"The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.~As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse."
11310552|NCT03165175|BG001|Baseline|Treatment as Usual|The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
11310553|NCT03165175|BG002|Baseline|Total|Total of all reporting groups
11310554|NCT03165175|FG000|Participant Flow|App + Treatment as Usual|"The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. The educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.~As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse."
11310555|NCT03165175|FG001|Participant Flow|Treatment as Usual|The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
11310556|NCT03165175|OG000|Outcome|App + Treatment as Usual|"The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.~As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse."
11310557|NCT03165175|OG001|Outcome|Treatment as Usual|The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
11310558|NCT03165175|EG000|Reported Event|App + Treatment as Usual|"The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.~As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse."
11310559|NCT03165175|EG001|Reported Event|Treatment as Usual|The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
11310560|NCT03165617|BG000|Baseline|QIVc (≥2 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310561|NCT03165617|BG001|Baseline|Non-Influenza Comparator Vaccine|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310562|NCT03165617|BG002|Baseline|Total|Total of all reporting groups
11310563|NCT03165617|FG000|Participant Flow|QIVc (≥2 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310564|NCT03165617|FG001|Participant Flow|Non-Influenza Comparator Vaccine|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310565|NCT03165617|OG000|Outcome|QIVc (≥2 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310566|NCT03165617|OG001|Outcome|Non-Influenza Comparator Vaccine|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310567|NCT03165617|OG000|Outcome|QIVc (≥3 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310568|NCT03165617|OG002|Outcome|QIVc (≥2 Years to <9 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310569|NCT03165617|OG003|Outcome|Comparator (≥2 Years to <9 Years of Age)|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310570|NCT03165617|OG004|Outcome|QIVc (≥4 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310571|NCT03165617|OG005|Outcome|Comparator (≥4 Years to <18 Years of Age)|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310572|NCT03165617|OG006|Outcome|QIVc (≥9 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310573|NCT03165617|OG007|Outcome|Comparator (≥9 Years to <18 Years of Age)|"Non-influenza Comparator Vaccine:~Non-influenza comparator vaccine for intramuscular use"
11310574|NCT03165617|OG007|Outcome|Comparator (≥9 Years to <18 Years of Age)|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310575|NCT03165617|OG002|Outcome|QIVc (≥2 Years to <9 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strain"
11310576|NCT03165617|OG006|Outcome|QIVc (≥9 Years to <18 Years of Age)|"QIVc: Cell-derived Quadrivalent Influenza Vaccine~for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310577|NCT03165617|OG000|Outcome|QIVc (≥2 Years to <9 Years of Age) - Season 2|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains~** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines."
11310578|NCT03165617|OG001|Outcome|Comparator (≥2 Years to <9 Years of Age) - Season 2|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine"
11310579|NCT03165617|OG002|Outcome|QIVc (≥2 Years to <9 Years of Age) - Season 3|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains~** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines."
11310580|NCT03165617|OG003|Outcome|Comparator (≥2 Years to <9 Years of Age) - Season 3|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine"
11310581|NCT03165617|OG001|Outcome|Comparator (≥2 Years to <9 Years of Age)|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine"
11310582|NCT03165617|OG003|Outcome|Non-Influenza Comparator Vaccine|"Non-influenza Comparator Vaccine:~Non-influenza comparator vaccine for intramuscular use"
11310583|NCT03165617|OG000|Outcome|QIVc (≥2 Years to <9 Years of Age) - Season 2|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310584|NCT03165617|OG001|Outcome|Comparator (≥2 Years to <18 Years of Age)|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine"
11310585|NCT03165617|EG000|Reported Event|QIVc (≥2 Years to <18 Years of Age)|"Cell-derived Seasonal Quadrivalent Influenza Vaccine~QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains"
11310586|NCT03165617|EG001|Reported Event|Non-Influenza Comparator Vaccine|"Non-Influenza Comparator Vaccine~Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use"
11310587|NCT03165981|BG000|Baseline|Simultaneous Vaccination Arm|"In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
10848544|NCT00290342|OG001|Outcome|Infanrix + IMOVAX Polio Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
11310588|NCT03165981|BG001|Baseline|Sequential Vaccination Arm|"In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310589|NCT03165981|BG002|Baseline|Total|Total of all reporting groups
11310590|NCT03165981|FG000|Participant Flow|Simultaneous Vaccination Arm|"In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310591|NCT03165981|FG001|Participant Flow|Sequential Vaccination Arm|"In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310592|NCT03165981|OG000|Outcome|Simultaneous Vaccination Arm|"In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310593|NCT03165981|OG001|Outcome|Sequential Vaccination Arm|"In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310594|NCT03165981|EG000|Reported Event|Simultaneous Vaccination Arm|"In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310595|NCT03165981|EG001|Reported Event|Sequential Vaccination Arm|"In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.~PCV13: ACIP Recommended vaccine~DTaP: ACIP Recommended vaccine~IIV: ACIP Recommended vaccine"
11310596|NCT03166124|BG000|Baseline|Elderly Adults|Male and female participants age 65 or older inclusive.
11310597|NCT03166124|BG001|Baseline|Younger Adults|Male and female participants age 18 to 45 inclusive.
11310598|NCT03166124|BG002|Baseline|Total|Total of all reporting groups
11310599|NCT03166124|FG000|Participant Flow|Sequence 1 AB Elderly Adults|"Sequence 1:~A: Single, subcutaneous (SC) 15-U dose of LY900014 in Period 1. B: Single, SC 15-U dose of Humalog in Period 2. Washout period of 3-15 days between study drug administration."
11310600|NCT03166124|FG001|Participant Flow|Sequence 1 AB Younger Adults|Sequence 1 A: Single, SC 15-U dose of LY900014 in Period 1. B: single, SC 15-U dose of Humalog in Period 2. Washout 3-15 days between study drug administration.
11310601|NCT03166124|FG002|Participant Flow|Sequence 2 BA Elderly Adults|"Sequence 2:~B: Single, SC 15-U dose of Humalog in Period 1. A: Single, SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration."
11310602|NCT03166124|FG003|Participant Flow|Sequence 2 BA Younger Adults|"Sequence 2:~B: Single, SC 15-U dose of Humalog in Period 1. A: Single SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration."
11310603|NCT03166124|OG000|Outcome|Elderly Adults LY900014|All elderly adults who received a single 15-U SC dose LY900014.
11310604|NCT03166124|OG001|Outcome|Elderly Adults Humalog|All elderly adults who received a single 15-U SC dose Humalog.
11310605|NCT03166124|OG002|Outcome|Younger Adults LY900014|All younger adults who received a single 15-U SC dose LY900014.
11310606|NCT03166124|OG003|Outcome|Younger Adults Humalog|All younger adults who received single 15-U SC dose Humalog.
11310607|NCT03166124|OG003|Outcome|Younger Adults Humalog|All younger adults who received a single 15-U SC dose Humalog.
11310608|NCT03166124|EG000|Reported Event|Elderly Adults LY900014|Single, subcutaneous (SC) 15-U dose of LY900014.
11310609|NCT03166124|EG001|Reported Event|Elderly Adults Humalog|Single, SC 15-U dose of Humalog.
11310610|NCT03166124|EG002|Reported Event|Younger Adults LY900014|Single, SC 15-U dose of LY900014.
11310611|NCT03166124|EG003|Reported Event|Younger Adults Humalog|Single, SC 15-U dose of Humalog.
11310612|NCT03166215|BG000|Baseline|Part 1: Placebo|TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
11310613|NCT03166215|BG001|Baseline|Part 1: TAK-935|TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
11310614|NCT03166215|BG002|Baseline|Total|Total of all reporting groups
11310615|NCT03166215|FG000|Participant Flow|Part 1: Placebo|TAK-935 matching-placebo tablets, orally or through gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) from Days 1 to 30 in dose titration period.
11310616|NCT03166215|FG001|Participant Flow|Part 1: TAK-935|TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
11310617|NCT03166215|FG002|Participant Flow|Part 2: TAK-935|TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
11310618|NCT03166215|OG000|Outcome|Part 1: Placebo|TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
11310619|NCT03166215|OG001|Outcome|Part 1: TAK-935|TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
11310620|NCT03166215|OG002|Outcome|Part 2: TAK-935|TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
11310621|NCT03166215|OG000|Outcome|TAK-935 100 mg BID|TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID for 10 days in Part 1 and for 44 days in Part 2.
11310622|NCT03166215|OG001|Outcome|TAK-935 200 mg BID|TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID for 10 days in Part 1 and Part 2.
11310623|NCT03166215|OG002|Outcome|TAK-935 300 mg BID|TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID for 10 days in Part 1 and for 44 days in Part 2.
11310624|NCT03166215|EG000|Reported Event|Part 1: Placebo|TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
11310625|NCT03166215|EG001|Reported Event|Part 1: TAK-935|TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
11310626|NCT03166215|EG002|Reported Event|Part 2: TAK-935|TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
11310627|NCT03166735|BG000|Baseline|Placebo|Matching placebo taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated placebo tablets were supplied. For blinding reasons, all patients took 5 tablets placebo daily.
11310628|NCT03166735|BG001|Baseline|BI 1467335 1 Milligram (mg)|1 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310629|NCT03166735|BG002|Baseline|BI 1467335 3 Milligram (mg)|3 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310630|NCT03166735|BG003|Baseline|BI 1467335 6 Milligram (mg)|6 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310631|NCT03166735|BG004|Baseline|BI 1467335 10 Milligram (mg)|10 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310632|NCT03166735|BG005|Baseline|Total|Total of all reporting groups
11310633|NCT03166735|FG000|Participant Flow|Placebo|Matching placebo taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated placebo tablets were supplied. For blinding reasons, all patients took 5 tablets placebo daily.
11310634|NCT03166735|FG001|Participant Flow|BI 1467335 1 Milligram (mg)|1 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310635|NCT03166735|FG002|Participant Flow|BI 1467335 3 Milligram (mg)|3 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310636|NCT03166735|FG003|Participant Flow|BI 1467335 6 Milligram (mg)|6 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310637|NCT03166735|FG004|Participant Flow|BI 1467335 10 Milligram (mg)|10 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310638|NCT03166735|OG000|Outcome|Placebo|Matching placebo taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated placebo tablets were supplied. For blinding reasons, all patients took 5 tablets placebo daily.
11310639|NCT03166735|OG001|Outcome|BI 1467335 1 Milligram (mg)|1 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310640|NCT03166735|OG002|Outcome|BI 1467335 3 Milligram (mg)|3 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310641|NCT03166735|OG003|Outcome|BI 1467335 6 Milligram (mg)|6 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310642|NCT03166735|OG004|Outcome|BI 1467335 10 Milligram (mg)|10 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310643|NCT03166735|EG000|Reported Event|Placebo|Matching placebo taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated placebo tablets were supplied. For blinding reasons, all patients took 5 tablets placebo daily.
11310644|NCT03166735|EG001|Reported Event|BI 1467335 1 Milligram (mg)|1 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310645|NCT03166735|EG002|Reported Event|BI 1467335 3 Milligram (mg)|3 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310646|NCT03166735|EG003|Reported Event|BI 1467335 6 Milligram (mg)|6 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310647|NCT03166735|EG004|Reported Event|BI 1467335 10 Milligram (mg)|10 milligram (mg) BI 1467335 taken daily for 12 weeks. Tablets taken orally with water in the morning, fasted, 1 hour before breakfast. Film-coated tablets were supplied as 1 mg and 5 mg dose strengths. For blinding reasons, all patients took 5 tablets verum or placebo daily.
11310648|NCT03166735|EG005|Reported Event|Total BI 1467335|All participant who took a dose of BI 1467335.
11333147|NCT03509948|FG000|Participant Flow|3 mg Cytisine, Schedule A: Fed Then Fasted|"Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state)."
11333148|NCT03509948|FG001|Participant Flow|3 mg Cytisine, Schedule B: Fasted Then Fed|"Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)."
11333149|NCT03509948|OG000|Outcome|3 mg Cytisine: Fed|Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)
11333150|NCT03509948|OG001|Outcome|3 mg Cytisine: Fasted|Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state)
11333151|NCT03509948|EG000|Reported Event|3 mg Cytisine: Fed|Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)
11310649|NCT03167073|BG000|Baseline|BreastFeeding Friend (BFF)|"BFF is a novel android app initially created in Microsoft PowerPoint with the results of a well-validated questionnaire administered to the target patient population, in which participants identified barriers preventing them from starting or continuing breastfeeding. The app was then modified by a multidisciplinary team of neonatologists, perinatologists, and certified lactation consultants. The finalized prototype was presented to three focus groups of test users sociodemographically similar to the target population. This approach allowed BFF to be adjusted to maximize the users' experience per their opinions. Once the focus groups' feedback was consistent, the app prototype was provided to a freelance coding team at Washington University of St. Louis, which built a native android app.~BreastFeeding Friend (BFF): A novel android app designed to improve breastfeeding rates among low-income women"
11310650|NCT03167073|BG001|Baseline|Dummy App|"The dummy app looks identical to BFF but is limited to a few pages of information on breastfeeding that is provided in hand-out form during routine prenatal care.~dummy app: A novel android app that looks identical to the intervention app (BFF) but contains limited content."
11310651|NCT03167073|BG002|Baseline|Total|Total of all reporting groups
11310652|NCT03167073|FG000|Participant Flow|BreastFeeding Friend (BFF)|"BFF is a novel android app initially created in Microsoft PowerPoint with the results of a well-validated questionnaire administered to the target patient population, in which participants identified barriers preventing them from starting or continuing breastfeeding. The app was then modified by a multidisciplinary team of neonatologists, perinatologists, and certified lactation consultants. The finalized prototype was presented to three focus groups of test users sociodemographically similar to the target population. This approach allowed BFF to be adjusted to maximize the users' experience per their opinions. Once the focus groups' feedback was consistent, the app prototype was provided to a freelance coding team at Washington University of St. Louis, which built a native android app.~BreastFeeding Friend (BFF): A novel android app designed to improve breastfeeding rates among low-income women"
11310653|NCT03167073|FG001|Participant Flow|Dummy App|"The dummy app looks identical to BFF but is limited to a few pages of information on breastfeeding that is provided in hand-out form during routine prenatal care.~dummy app: A novel android app that looks identical to the intervention app (BFF) but contains limited content."
11310654|NCT03167073|OG000|Outcome|BreastFeeding Friend (BFF)|"BFF is a novel android app initially created in Microsoft PowerPoint with the results of a well-validated questionnaire administered to the target patient population, in which participants identified barriers preventing them from starting or continuing breastfeeding. The app was then modified by a multidisciplinary team of neonatologists, perinatologists, and certified lactation consultants. The finalized prototype was presented to three focus groups of test users sociodemographically similar to the target population. This approach allowed BFF to be adjusted to maximize the users' experience per their opinions. Once the focus groups' feedback was consistent, the app prototype was provided to a freelance coding team at Washington University of St. Louis, which built a native android app.~BreastFeeding Friend (BFF): A novel android app designed to improve breastfeeding rates among low-income women"
11310655|NCT03167073|OG001|Outcome|Dummy App|"The dummy app looks identical to BFF but is limited to a few pages of information on breastfeeding that is provided in hand-out form during routine prenatal care.~dummy app: A novel android app that looks identical to the intervention app (BFF) but contains limited content."
11310656|NCT03167073|EG000|Reported Event|BreastFeeding Friend (BFF)|"BFF is a novel android app initially created in Microsoft PowerPoint with the results of a well-validated questionnaire administered to the target patient population, in which participants identified barriers preventing them from starting or continuing breastfeeding. The app was then modified by a multidisciplinary team of neonatologists, perinatologists, and certified lactation consultants. The finalized prototype was presented to three focus groups of test users sociodemographically similar to the target population. This approach allowed BFF to be adjusted to maximize the users' experience per their opinions. Once the focus groups' feedback was consistent, the app prototype was provided to a freelance coding team at Washington University of St. Louis, which built a native android app.~BreastFeeding Friend (BFF): A novel android app designed to improve breastfeeding rates among low-income women"
11310657|NCT03167073|EG001|Reported Event|Dummy App|"The dummy app looks identical to BFF but is limited to a few pages of information on breastfeeding that is provided in hand-out form during routine prenatal care.~dummy app: A novel android app that looks identical to the intervention app (BFF) but contains limited content."
11310658|NCT03167151|BG000|Baseline|Safety run-in Phase Cohort 1|Cohort 1 in the safety run-in phase. Day 1 starting dose 50mg intravesical pembrolizumab
11310659|NCT03167151|BG001|Baseline|Safety run-in Phase Cohort 2|Cohort 2 in the safety run-in phase. Day 1 starting dose 100mg intravesical pembrolizumab
11310660|NCT03167151|BG002|Baseline|Safety run-in Phase Cohort 3|Cohort 3 in the safety run-in phase. Day 1 starting dose 200mg intravesical pembrolizumab
11310661|NCT03167151|BG003|Baseline|Total|Total of all reporting groups
11310662|NCT03167151|FG000|Participant Flow|Safety run-in Phase Cohort 1|Cohort 1 in the safety run-in phase. Day 1 starting dose 50mg intravesical pembrolizumab
11310663|NCT03167151|FG001|Participant Flow|Safety run-in Phase Cohort 2|Cohort 2 in the safety run-in phase. Day 1 starting dose 100mg intravesical pembrolizumab
11310664|NCT03167151|FG002|Participant Flow|Safety run-in Phase Cohort 3|Cohort 3 in the safety run-in phase. Day 1 starting dose 200mg intravesical pembrolizumab
11310665|NCT03167151|OG000|Outcome|Safety run-in Phase Cohort 1|Cohort 1 in the safety run-in phase. Day 1 starting dose 50mg intravesical pembrolizumab
11310666|NCT03167151|OG001|Outcome|Safety run-in Phase Cohort 2|Cohort 2 in the safety run-in phase. Day 1 starting dose 100mg intravesical pembrolizumab
11310667|NCT03167151|OG002|Outcome|Safety run-in Phase Cohort 3|Cohort 3 in the safety run-in phase. Day 1 starting dose 200mg intravesical pembrolizumab
11310668|NCT03167151|EG000|Reported Event|Safety run-in Phase Cohort 1|Cohort 1 in the safety run-in phase. Day 1 starting dose 50mg intravesical pembrolizumab
11310669|NCT03167151|EG001|Reported Event|Safety run-in Phase Cohort 2|Cohort 2 in the safety run-in phase. Day 1 starting dose 100mg intravesical pembrolizumab
11310670|NCT03167151|EG002|Reported Event|Safety run-in Phase Cohort 3|Cohort 3 in the safety run-in phase. Day 1 starting dose 200mg intravesical pembrolizumab
11333152|NCT03509948|EG001|Reported Event|3 mg Cytisine: Fasted|Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state)
11310671|NCT03167359|BG000|Baseline|Participants With Stage 0-III Breast Cancer|"Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.~Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions."
11310672|NCT03167359|FG000|Participant Flow|Participants With Stage 0-III Breast Cancer|"Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.~Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions."
11310673|NCT03167359|OG000|Outcome|Participants With Stage 0-III Breast Cancer|"Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.~Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions."
11310674|NCT03167359|EG000|Reported Event|Participants With Stage 0-III Breast Cancer|"Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.~Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions."
11310675|NCT03167411|BG000|Baseline|Bexagliflozin, Then Bexagliflozin With Exenatide|After an overnight fast, subjects received a single oral dose of bexagliflozin tablets, 20 mg alone 30 min before breakfast. After a washout period of 7 days, the subjects then received a subcutaneous injection of exenatide 10 µg at 30 min prior to a single oral dose of bexagliflozin, and 1 hr before breakfast and followed by the second dose of exenatide alone 1 hr prior to the evening meal.
11310676|NCT03167411|BG001|Baseline|Bexagliflozin With Exenatide, Then Bexagliflozin|Subjects received a subcutaneous injection of exenatide at 10 µg twice a day (bid) with an initial dose 30 min prior to a single oral dose of bexagliflozin tablets, 20 mg, and 1 hr before breakfast, followed by the second dose of exenatide alone 1 hr prior to the evening meal. After a washout period of 7 days, the subjects then received a single oral dose of bexagliflozin tablets, 20 mg alone 30 min before breakfast.
11310677|NCT03167411|BG002|Baseline|Total|Total of all reporting groups
11310678|NCT03167411|FG000|Participant Flow|Bexagliflozin, Then Bexagliflozin With Exenatide|After an overnight fast, subjects received a single oral dose of bexagliflozin tablets, 20 mg alone 30 min before breakfast. After a washout period of 7 days, the subjects then received a subcutaneous injection of exenatide 10 µg at 30 min prior to a single oral dose of bexagliflozin, and 1 hr before breakfast and followed by the second dose of exenatide alone 1 hr prior to the evening meal.
11310679|NCT03167411|FG001|Participant Flow|Bexagliflozin With Exenatide, Then Bexagliflozin Alone|Subjects received a subcutaneous injection of exenatide at 10 µg twice a day (bid) with an initial dose 30 min prior to a single oral dose of bexagliflozin tablets, 20 mg, and 1 hr before breakfast, followed by the second dose of exenatide alone 1 hr prior to the evening meal. After a washout period of 7 days, the subjects then received a single oral dose of bexagliflozin tablets, 20 mg alone 30 min before breakfast.
11310680|NCT03167411|OG000|Outcome|Bexagliflozin|Bexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose
11310681|NCT03167411|OG001|Outcome|Bexagliflozin With Exenatide|"Bexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose~Exenatide: Byetta® (Exenatide), 10 µg, subcutaneous injection, twice a day (bid), two doses"
11310682|NCT03167411|EG000|Reported Event|Bexagliflozin|Bexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose
11310683|NCT03167411|EG001|Reported Event|Bexagliflozin With Exenatide|"Bexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose~Exenatide: Byetta® (Exenatide), 10 µg, subcutaneous injection, twice a day (bid), two doses"
11310684|NCT03167541|BG000|Baseline|All Study Participants|"RB Naproxen Sodium 2 x 220 mg single dose by mouth under fasted condition.~Aleve® Naproxen Sodium 2 x 220 mg single dose by mouth under fasted condition.~There was a 5 to 8 days washout period between each administration."
11310685|NCT03167541|FG000|Participant Flow|RB Naproxen (Test) First, Then Aleve Naproxen (Reference)|Participants first received RB naproxen sodium 2 x 220 mg tablets single-oral dose in a fasting condition. After a washout period of 5-8 Days, they then received Aleve naproxen sodium 2 x 220 mg tablets single-oral dose in a fasting condition.
11310686|NCT03167541|FG001|Participant Flow|Aleve Naproxen (Reference) First, Then RB Naproxen (Test)|Participants first received Aleve naproxen sodium 2 x 220 mg tablets single-oral dose in a fasting condition. After a washout period of 5-8 Days, they then received RB naproxen sodium 2 x 220 mg tablets single-oral dose in a fasting condition.
11310687|NCT03167541|OG000|Outcome|Test: RB Naproxen Sodium 2 x 220 mg|RB naproxen sodium 2 x 220 mg tablets single dose by mouth under fasted condition
11310688|NCT03167541|OG001|Outcome|Reference: Aleve Naproxen Sodium 2x220 mg|Aleve naproxen sodium 2 x 220 mg tablets single dose by mouth under fasted condition.
11310689|NCT03167541|OG001|Outcome|Reference: Aleve® Naproxen Sodium 2 x 220 mg|Aleve naproxen sodium 2 x 220 mg tablets single dose by mouth under fasted condition.
11310690|NCT03167541|EG000|Reported Event|Test: RB Naproxen Sodium 2 x 220 mg|RB Naproxen Sodium 2 x 220 mg single dose by mouth under fasted condition.
11310691|NCT03167541|EG001|Reported Event|Reference: Aleve® Naproxen Sodium 2 x 220 mg|Aleve Naproxen Sodium 2 x 220 mg single dose by mouth under fasted condition.
11310692|NCT03168022|BG000|Baseline|All Study Participants|All subjects that were randomized to receive all treatments.
11310693|NCT03168022|FG000|Participant Flow|Treatment A First, Then B|Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet [commercial manufacturer]), Washout 21 days, Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet [original manufacturer])
11310694|NCT03168022|FG001|Participant Flow|Treatment B First, Then A|Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet [original manufacturer]), Washout 21 days, Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet [commercial manufacturer])
11310695|NCT03168022|OG000|Outcome|Treatment A|All study subjects who were administered one TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) under fasting conditions and completed the study.
11310696|NCT03168022|OG001|Outcome|Treatment B|All study subject who were administered one TNX-102 SL 2.8 mg white tablet (original manufacturer) under fasting conditions and completed the study.
11310697|NCT03168022|OG000|Outcome|Treatment A|"1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.~Treatment A: 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved."
11310698|NCT03168022|OG001|Outcome|Treatment B|"1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.~Treatment B: 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved."
11310699|NCT03168022|EG000|Reported Event|Treatment A|All subjects who were administered TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer).
11310700|NCT03168022|EG001|Reported Event|Treatment B|All subjects who were administered TNX-102 SL 2.8 mg white yellow tablet (original manufacturer).
11310701|NCT03168295|BG000|Baseline|Diabetic Subjects|Diabetic renal transplant subjects with native kidneys intact who were Type 2 diabetics
11310702|NCT03168295|BG001|Baseline|Non-diabetic Subjects|Non-diabetic subjects after renal transplant with intact native kidneys
11310703|NCT03168295|BG002|Baseline|Control Group|Type 2 diabetic subjects who did not under go renal transplant
11310704|NCT03168295|BG003|Baseline|Total|Total of all reporting groups
11310705|NCT03168295|FG000|Participant Flow|Dapagliflozin First - Diabetic|Subjects who have undergone renal transplant are randomly assigned to receive either dapagliflozin first followed by the placebo
11310706|NCT03168295|FG001|Participant Flow|Placebo Oral Tablet First - Diabetic|Subjects who have undergone renal transplant are randomly assigned to receive placebo first followed by dapagliflozin
11310707|NCT03168295|FG002|Participant Flow|Dapagliflozin First - Non-diabetic|Non-diabetic subjects who have undergone renal transplant are randomly assigned to dapagliflozin first and then receive placebo
11310708|NCT03168295|FG003|Participant Flow|Placebo Oral Tablet First - Non-diabetic|Non-diabetic subjects who have undergone renal transplant are randomly assigned to placebo first and then receive dapagliflozin
11310709|NCT03168295|FG004|Participant Flow|Control Group|Type 2 Diabetic subjects who did not undergo renal transplant and received dapagliflozin
11310710|NCT03168295|OG000|Outcome|Diabetic Subjects|Renal transplant subjects with native kidneys intact who were Type 2 diabetics
11310711|NCT03168295|OG001|Outcome|Non-diabetic Subjects|Non-diabetic subjects after renal transplant with intact native kidneys
11310712|NCT03168295|OG002|Outcome|Control Group|Type 2 diabetic subjects who did not undergo renal surgery and received dapagliflozin
11310713|NCT03168295|OG001|Outcome|Control Group|Subjects who are type 2 diabetics who did not undergo renal transplant
11310714|NCT03168295|EG000|Reported Event|Diabetic Subjects Dapagliflozin|Diabetic subjects who have undergone kidney surgery, and have a dapagliflozin infusion
11310715|NCT03168295|EG001|Reported Event|Diabetic Subjects Placebo|Diabetic subjects who have undergone kidney surgery, and have a placebo infusion
11310716|NCT03168295|EG002|Reported Event|Non-diabetic Subjects Dapagliflozin|Non-Diabetic subjects who have undergone kidney surgery, and have a dapagliflozin infusion
11310717|NCT03168295|EG003|Reported Event|Non-diabetic Subjects Placebo|Non-Diabetic subjects who have undergone kidney surgery, and have a placebo infusion
11310718|NCT03168295|EG004|Reported Event|Control Group|Type 2 Diabetic subjects who have not undergone renal surgery
11310719|NCT03168308|BG000|Baseline|Neostigmine & Glycopyrrolate|"Patients randomized to receive Neostigmine w/ Glycopyrrolate~Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg"
11310720|NCT03168308|BG001|Baseline|Sugammadex|"Patients randomized to receive Sugammadex~Sugammadex: Sugammadex 2 mg/kg"
11310721|NCT03168308|BG002|Baseline|Total|Total of all reporting groups
11310722|NCT03168308|FG000|Participant Flow|Neostigmine & Glycopyrrolate|"Patients randomized to receive Neostigmine w/ Glycopyrrolate~Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg"
11310723|NCT03168308|FG001|Participant Flow|Sugammadex|"Patients randomized to receive Sugammadex~Sugammadex: Sugammadex 2 mg/kg"
11310724|NCT03168308|OG000|Outcome|Neostigmine & Glycopyrrolate|"Patients randomized to receive Neostigmine w/ Glycopyrrolate~Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg"
11310725|NCT03168308|OG001|Outcome|Sugammadex|"Patients randomized to receive Sugammadex~Sugammadex: Sugammadex 2 mg/kg"
11310726|NCT03168308|EG000|Reported Event|Neostigmine & Glycopyrrolate|"Patients randomized to receive Neostigmine w/ Glycopyrrolate~Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg"
11310727|NCT03168308|EG001|Reported Event|Sugammadex|"Patients randomized to receive Sugammadex~Sugammadex: Sugammadex 2 mg/kg"
11310728|NCT03168321|BG000|Baseline|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310729|NCT03168321|BG001|Baseline|Vehicle Lotion|IDP-123 Vehicle Lotion
11310730|NCT03168321|BG002|Baseline|Total|Total of all reporting groups
11310731|NCT03168321|FG000|Participant Flow|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310732|NCT03168321|FG001|Participant Flow|Vehicle Lotion|IDP-123 Vehicle Lotion
11310733|NCT03168321|OG000|Outcome|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310734|NCT03168321|OG001|Outcome|Vehicle Lotion|IDP-123 Vehicle Lotion
11310735|NCT03168321|EG000|Reported Event|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310736|NCT03168321|EG001|Reported Event|Vehicle Lotion|IDP-123 Vehicle Lotion
11310737|NCT03168334|BG000|Baseline|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310738|NCT03168334|BG001|Baseline|Vehicle Lotion|IDP-123 Vehicle Lotion
11310739|NCT03168334|BG002|Baseline|Total|Total of all reporting groups
11310740|NCT03168334|FG000|Participant Flow|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310741|NCT03168334|FG001|Participant Flow|Vehicle Lotion|IDP-123 Vehicle Lotion
11310742|NCT03168334|OG000|Outcome|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310743|NCT03168334|OG001|Outcome|Vehicle Lotion|IDP-123 Vehicle Lotion
11310744|NCT03168334|EG000|Reported Event|IDP-123 Lotion|IDP-123 (Tazarotene 0.045%) Lotion
11310745|NCT03168334|EG001|Reported Event|Vehicle Lotion|IDP-123 Vehicle Lotion
11310746|NCT03168425|BG000|Baseline|Tailored|"Participants will be prescribed an opioid based on a formula derived from inpatient opioid use~Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use"
11310747|NCT03168425|BG001|Baseline|Control|"Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.~Control: Participants will be prescribed 30 tablets of oxycodone 5mg"
11310748|NCT03168425|BG002|Baseline|Total|Total of all reporting groups
11310749|NCT03168425|FG000|Participant Flow|Tailored|"Participants will be prescribed an opioid based on a formula derived from inpatient opioid use~Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use"
11310750|NCT03168425|FG001|Participant Flow|Control|"Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.~Control: Participants will be prescribed 30 tablets of oxycodone 5mg"
11310751|NCT03168425|OG000|Outcome|Tailored|"Participants will be prescribed an opioid based on a formula derived from inpatient opioid use~Participants who received an individualized prescription were discharged with 14 [interquartile range 12-16] oxycodone 5mg tablets."
11310752|NCT03168425|OG001|Outcome|Control|"Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.~Control: Participants will be prescribed 30 tablets of oxycodone 5mg"
11310753|NCT03168425|OG000|Outcome|Tailored|"Participants will be prescribed an opioid based on a formula derived from inpatient opioid use~Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use"
11310754|NCT03168425|EG000|Reported Event|Tailored|"Participants will be prescribed an opioid based on a formula derived from inpatient opioid use~Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use"
10848545|NCT00290342|EG000|Reported Event|Infanrix-IPV Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
11310755|NCT03168425|EG001|Reported Event|Control|"Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.~Control: Participants will be prescribed 30 tablets of oxycodone 5mg"
11310756|NCT03168542|BG000|Baseline|Dispensed Subjects|All subjects dispensed at least one study lens.
11310757|NCT03168542|FG000|Participant Flow|Toric Multifocal/Toric Multifocal|Subjects that wore the Toric Multifocal contact lens in both eyes (Right/Left) for the entire duration of the study.
11310758|NCT03168542|FG001|Participant Flow|Toric Multifocal/ Multifocal|Subjects that wore the Toric Multifocal contact lens in their right eye and the Sphere Multifocal contact lens in their left eye for the entire duration of the study.
11310759|NCT03168542|FG002|Participant Flow|Multifocal/Toric Multifocal|Subjects that wore the Sphere Multifocal contact lens in their right eye and the Toric Multifocal contact lens in their left eye for the entire duration of the study.
11310760|NCT03168542|OG000|Outcome|JJVC Fitting Guides|ECPs used JJCV Fitting guides to fit subjects with the Toric Multifocal contact lens in both eyes and the Sphere Multifocal contact lens in both eyes.
11310761|NCT03168542|EG000|Reported Event|Toric Multifocal|Subjects that wore the Toric Multifocal contact lens at any point during this study.
11310762|NCT03168542|EG001|Reported Event|Multifocal|Subjects that wore the Sphere Multifocal contact lens at any point during this study.
11310763|NCT03168711|BG000|Baseline|Inosine|"Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL."
11310764|NCT03168711|BG001|Baseline|Placebo|"Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL."
11310765|NCT03168711|BG002|Baseline|Total|Total of all reporting groups
11310766|NCT03168711|FG000|Participant Flow|Inosine|"Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL."
11310767|NCT03168711|FG001|Participant Flow|Placebo|"Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL."
11310768|NCT03168711|OG000|Outcome|Inosine|"Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL."
11310769|NCT03168711|OG001|Outcome|Placebo|"Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL."
11333153|NCT03509974|BG000|Baseline|Bone Anchored Hearing Device (OSIA)|"All subjects will receive the Bone Anchored Hearing Device (OSIA)~Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system"
11310770|NCT03168711|EG000|Reported Event|Inosine|"Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL."
11310771|NCT03168711|EG001|Reported Event|Placebo|"Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.~Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL."
11310772|NCT03168841|BG000|Baseline|Intervention Group, Receiving Medication|"Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.~Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks."
11310773|NCT03168841|FG000|Participant Flow|Intervention Group, Receiving Medication|"Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.~Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks."
11310774|NCT03168841|OG000|Outcome|Intervention Group, Receiving Medication|"Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.~Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks."
11310775|NCT03168841|EG000|Reported Event|Intervention Group, Receiving Medication|"Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.~Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks."
11310776|NCT03168919|BG000|Baseline|Chemoradiation With MRI Assessment|"This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.~Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.~Temozolomide: Standard of care temozolomide will be given along with radiation therapy~MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy."
11310777|NCT03168919|FG000|Participant Flow|Chemoradiation With MRI Assessment|"This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.~Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.~Temozolomide: Standard of care temozolomide will be given along with radiation therapy~MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy."
11310778|NCT03168919|OG000|Outcome|Chemoradiation With MRI Assessment|"This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.~Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.~Temozolomide: Standard of care temozolomide will be given along with radiation therapy~MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy."
11310779|NCT03168919|OG000|Outcome|Chemoradiation Arm|Diffuion MRI was performed before, during and after completion of radiation
11310780|NCT03168919|OG000|Outcome|Chemoradiation Arm|Volumetric MRI was performed before, during and after completion of radiation
11310781|NCT03168919|OG000|Outcome|Chemoradiation Arm|Perfusion MRI was performed before, during and after completion of radiation
11310782|NCT03168919|OG000|Outcome|Chemoradiation Arm|Only 3 subjects were imaged
11310783|NCT03168919|EG000|Reported Event|Chemoradiation With MRI Assessment|"This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.~Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.~Temozolomide: Standard of care temozolomide will be given along with radiation therapy~MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy."
11310784|NCT03169062|BG000|Baseline|All Patients|"Gated Stationary Chest Tomosynthesis~Gated Stationary Chest Tomosynthesis: The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes."
11310785|NCT03169062|FG000|Participant Flow|All Patients|"Gated Stationary Chest Tomosynthesis~Gated Stationary Chest Tomosynthesis: The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes."
11310786|NCT03169062|OG000|Outcome|All Patients|"Gated Stationary Chest Tomosynthesis~Gated Stationary Chest Tomosynthesis: The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes."
11310787|NCT03169062|EG000|Reported Event|All Patients|"Gated Stationary Chest Tomosynthesis~Gated Stationary Chest Tomosynthesis: The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes."
11310788|NCT03169153|BG000|Baseline|Overall|Lotrafilcon B and senofilcon C contact lenses worn during Period 1 and Period 2 in a crossover assignment.
11310789|NCT03169153|FG000|Participant Flow|AOHG Then VITA|Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.
11310790|NCT03169153|FG001|Participant Flow|VITA Then AOHG|Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.
11310791|NCT03169153|OG000|Outcome|AOHG|Lotrafilcon B contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.
11310792|NCT03169153|OG001|Outcome|VITA|Senofilcon C contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.
11310793|NCT03169153|EG000|Reported Event|AOHG|All subjects exposed to lotrafilcon B contact lenses
11310794|NCT03169153|EG001|Reported Event|VITA|All subjects exposed to senofilcon C contact lenses
11310795|NCT03169244|BG000|Baseline|Bupropion XL|Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
11310796|NCT03169244|BG001|Baseline|Placebo|Placebo will be initiated on Day 1 and continue throughout the course of the study.
11310797|NCT03169244|BG002|Baseline|Total|Total of all reporting groups
11310798|NCT03169244|FG000|Participant Flow|Bupropion XL|Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
11310799|NCT03169244|FG001|Participant Flow|Placebo|Placebo will be initiated on Day 1 and continue throughout the course of the study.
11310800|NCT03169244|OG000|Outcome|Bupropion XL|Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
11310801|NCT03169244|OG001|Outcome|Placebo|Placebo will be initiated on Day 1 and continue throughout the course of the study.
11310802|NCT03169244|EG000|Reported Event|Bupropion XL|Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
11310803|NCT03169244|EG001|Reported Event|Placebo|Placebo will be initiated on Day 1 and continue throughout the course of the study.
11310804|NCT03169816|BG000|Baseline|Lorcaserin|"10 mg capsule taken twice daily of lorcaserin~Lorcaserin: Lorcaserin 10mg, twice daily"
11310805|NCT03169816|BG001|Baseline|Placebo|"a placebo comparator capsule taken twice daily~Placebo: Matched placebo for lorcaserin condition dosed twice daily"
11310806|NCT03169816|BG002|Baseline|Total|Total of all reporting groups
11310807|NCT03169816|FG000|Participant Flow|Lorcaserin|"10 mg capsule taken twice daily of lorcaserin~Lorcaserin: Lorcaserin 10mg, twice daily"
11310808|NCT03169816|FG001|Participant Flow|Placebo|"a placebo comparator capsule taken twice daily~Placebo: Matched placebo for lorcaserin condition dosed twice daily"
11310809|NCT03169816|OG000|Outcome|Lorcaserin|"10 mg capsule taken twice daily of lorcaserin~Lorcaserin: Lorcaserin 10mg, twice daily"
11310810|NCT03169816|OG001|Outcome|Placebo|"a placebo comparator capsule taken twice daily~Placebo: Matched placebo for lorcaserin condition dosed twice daily"
11310811|NCT03169816|EG000|Reported Event|Lorcaserin|"10 mg capsule taken twice daily of lorcaserin~Lorcaserin: Lorcaserin 10mg, twice daily"
11310812|NCT03169816|EG001|Reported Event|Placebo|"a placebo comparator capsule taken twice daily~Placebo: Matched placebo for lorcaserin condition dosed twice daily"
11310813|NCT03170154|BG000|Baseline|Clareon IOL|Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
11310814|NCT03170154|FG000|Participant Flow|Clareon IOL|Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
11310815|NCT03170154|OG000|Outcome|Clareon IOL|Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
11310816|NCT03170154|OG000|Outcome|Pre-treatment|Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye, as well as overall systemic events.
11310817|NCT03170154|OG001|Outcome|Clareon IOL - Ocular|Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.
11310818|NCT03170154|OG002|Outcome|Systemic|Events reported in this group occurred after attempted implantation with the test article.
11310819|NCT03170154|EG000|Reported Event|Pre-treatment|Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye and non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.
11310820|NCT03170154|EG001|Reported Event|Clareon IOL - Ocular (Study Eye)|Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.
11310821|NCT03170154|EG002|Reported Event|Systemic and Ocular Non-Study (Non-Clareon) Eye|Events reported in this group occurred after attempted implantation with the test article and may include ocular events in the non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.
11310822|NCT03170193|BG000|Baseline|Placebo|Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
11310823|NCT03170193|BG001|Baseline|AMG 529 21 mg SC|Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
11310824|NCT03170193|BG002|Baseline|AMG 529 70 mg SC|Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
11310825|NCT03170193|BG003|Baseline|AMG 529 210 mg SC|Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
11310826|NCT03170193|BG004|Baseline|AMG 529 420 mg SC|Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
11310827|NCT03170193|BG005|Baseline|AMG 529 700 mg SC|Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
11310828|NCT03170193|BG006|Baseline|AMG 529 70 mg IV|Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
11310829|NCT03170193|BG007|Baseline|Total|Total of all reporting groups
11310830|NCT03170193|FG000|Participant Flow|Placebo|Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
11310831|NCT03170193|FG001|Participant Flow|AMG 529 21 mg SC|Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
11310832|NCT03170193|FG002|Participant Flow|AMG 529 70 mg SC|Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
11310833|NCT03170193|FG003|Participant Flow|AMG 529 210 mg SC|Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
11310834|NCT03170193|FG004|Participant Flow|AMG 529 420 mg SC|Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
11310835|NCT03170193|FG005|Participant Flow|AMG 529 700 mg SC|Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
11310836|NCT03170193|FG006|Participant Flow|AMG 529 70 mg IV|Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
11310837|NCT03170193|OG000|Outcome|Placebo|Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
11310838|NCT03170193|OG001|Outcome|AMG 529 21 mg SC|Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
11310839|NCT03170193|OG002|Outcome|AMG 529 70 mg SC|Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
11310840|NCT03170193|OG003|Outcome|AMG 529 210 mg SC|Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
11310841|NCT03170193|OG004|Outcome|AMG 529 420 mg SC|Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
11310842|NCT03170193|OG005|Outcome|AMG 529 700 mg SC|Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
11310843|NCT03170193|OG006|Outcome|AMG 529 70 mg IV|Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
11310844|NCT03170193|OG000|Outcome|AMG 529 21 mg SC|Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
11310845|NCT03170193|OG001|Outcome|AMG 529 70 mg SC|Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
11310846|NCT03170193|OG002|Outcome|AMG 529 210 mg SC|Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
11310847|NCT03170193|OG003|Outcome|AMG 529 420 mg SC|Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
11310848|NCT03170193|OG004|Outcome|AMG 529 700 mg SC|Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
11310849|NCT03170193|OG005|Outcome|AMG 529 70 mg IV|Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
11310850|NCT03170193|EG000|Reported Event|Placebo|Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.
11310851|NCT03170193|EG001|Reported Event|AMG 529 21 mg SC|Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.
11310852|NCT03170193|EG002|Reported Event|AMG 529 70 mg SC|Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.
11310853|NCT03170193|EG003|Reported Event|AMG 529 210 mg SC|Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.
11310854|NCT03170193|EG004|Reported Event|AMG 529 420 mg SC|Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.
11310855|NCT03170193|EG005|Reported Event|AMG 529 700 mg SC|Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.
11310856|NCT03170193|EG006|Reported Event|AMG 529 70 mg IV|Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.
11310857|NCT03170219|BG000|Baseline|Subcutaneous Furosemide and sc2wear Device|"Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.~subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care"
11310858|NCT03170219|BG001|Baseline|Usual Care|Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
11310859|NCT03170219|BG002|Baseline|Total|Total of all reporting groups
11310860|NCT03170219|FG000|Participant Flow|Subcutaneous Furosemide and sc2wear Device|"Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.~subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care"
11310861|NCT03170219|FG001|Participant Flow|Usual Care|Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
11310862|NCT03170219|OG000|Outcome|Subcutaneous Furosemide and sc2wear Device|"Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.~subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care"
11310863|NCT03170219|OG001|Outcome|Usual Care|Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
11310864|NCT03170219|EG000|Reported Event|Subcutaneous Furosemide and sc2wear Device|"Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.~subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care"
11310865|NCT03170219|EG001|Reported Event|Usual Care|Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
11310866|NCT03170232|BG000|Baseline|Placebo|Participants received one tablet of placebo with food twice daily for 52 weeks.
11310867|NCT03170232|BG001|Baseline|DNX HBr 35 mg|Participants received one tablet of DNX HBr 35 mg with food twice daily for 52 weeks.
11310868|NCT03170232|BG002|Baseline|Total|Total of all reporting groups
11310869|NCT03170232|FG000|Participant Flow|Placebo|Participants received one tablet of placebo with food twice daily for 52 weeks.
11310870|NCT03170232|FG001|Participant Flow|DNX HBr 35 mg|Participants received one tablet of DNX HBr 35 mg with food twice daily for 52 weeks.
11310871|NCT03170232|OG000|Outcome|Placebo|Participants received one tablet of placebo with food twice daily for 52 weeks.
11310872|NCT03170232|OG001|Outcome|DNX HBr 35 mg|Participants received one tablet of DNX HBr 35 mg with food twice daily for 52 weeks.
11310873|NCT03170232|EG000|Reported Event|Placebo|Participants received one tablet of placebo with food twice daily for 52 weeks.
11310874|NCT03170232|EG001|Reported Event|DNX HBr 35 mg|Participants received one tablet of DNX HBr 35 mg with food twice daily for 52 weeks.
11310875|NCT03170271|BG000|Baseline|Benralizumab|Patients received benralizumab 30 mg administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310876|NCT03170271|BG001|Baseline|Placebo|Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310877|NCT03170271|BG002|Baseline|Total|Total of all reporting groups
11310878|NCT03170271|FG000|Participant Flow|Benralizumab|Patients received benralizumab 30 milligrams (mg) administered subcutaneously (sc) in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An End of Treatment (EOT) visit was performed at Week 24.
11310879|NCT03170271|FG001|Participant Flow|Placebo|Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310880|NCT03170271|OG000|Outcome|Benralizumab|Patients received benralizumab 30 mg administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310881|NCT03170271|OG001|Outcome|Placebo|Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310882|NCT03170271|EG000|Reported Event|Benralizumab|Patients received benralizumab 30 mg administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310883|NCT03170271|EG001|Reported Event|Placebo|Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
11310884|NCT03170388|BG000|Baseline|IDP-126 Gel|"Gel~IDP-126 Gel: Gel"
11310885|NCT03170388|BG001|Baseline|IDP-126 Component A|"Component A~IDP-126 Component A: Component A"
11310886|NCT03170388|BG002|Baseline|IDP-126 Component B|"Component B~IDP-126 Component B: Component B"
11310887|NCT03170388|BG003|Baseline|IDP-126 Component C|"Component C~IDP-126 Component C: Component C"
11310888|NCT03170388|BG004|Baseline|IDP-126 Vehicle Gel|"Vehicle Gel~IDP-126 Vehicle Gel: Vehicle Gel"
11310889|NCT03170388|BG005|Baseline|Total|Total of all reporting groups
11310890|NCT03170388|FG000|Participant Flow|IDP-126 Gel|"Gel~IDP-126 Gel: Gel"
11310891|NCT03170388|FG001|Participant Flow|IDP-126 Component A|"Component A~IDP-126 Component A: Component A"
11310892|NCT03170388|FG002|Participant Flow|IDP-126 Component B|"Component B~IDP-126 Component B: Component B"
11310893|NCT03170388|FG003|Participant Flow|IDP-126 Component C|"Component C~IDP-126 Component C: Component C"
11310894|NCT03170388|FG004|Participant Flow|IDP-126 Vehicle Gel|"Vehicle Gel~IDP-126 Vehicle Gel: Vehicle Gel"
11310895|NCT03170388|OG000|Outcome|IDP-126 Gel|"Gel~IDP-126 Gel: Gel"
11310896|NCT03170388|OG001|Outcome|IDP-126 Component A|"Component A~IDP-126 Component A: Component A"
11310897|NCT03170388|OG002|Outcome|IDP-126 Component B|"Component B~IDP-126 Component B: Component B"
11310898|NCT03170388|OG003|Outcome|IDP-126 Component C|"Component C~IDP-126 Component C: Component C"
11310899|NCT03170388|OG004|Outcome|IDP-126 Vehicle Gel|"Vehicle Gel~IDP-126 Vehicle Gel: Vehicle Gel"
11310900|NCT03170388|EG000|Reported Event|IDP-126 Gel|"Gel~IDP-126 Gel: Gel"
11310901|NCT03170388|EG001|Reported Event|IDP-126 Component A|"Component A~IDP-126 Component A: Component A"
11310902|NCT03170388|EG002|Reported Event|IDP-126 Component B|"Component B~IDP-126 Component B: Component B"
11310903|NCT03170388|EG003|Reported Event|IDP-126 Component C|"Component C~IDP-126 Component C: Component C"
11310904|NCT03170388|EG004|Reported Event|IDP-126 Vehicle Gel|"Vehicle Gel~IDP-126 Vehicle Gel: Vehicle Gel"
11310905|NCT03170544|BG000|Baseline|Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310906|NCT03170544|BG001|Baseline|Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310907|NCT03170544|BG002|Baseline|Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310908|NCT03170544|BG003|Baseline|Part 1 (Healthy Adults) MK-1092 16 Nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
11310909|NCT03170544|BG004|Baseline|Part 1 (Healthy Adults) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310910|NCT03170544|BG005|Baseline|Part 1 (Healthy Adults) MK-1092 64 Nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310911|NCT03170544|BG006|Baseline|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Humalog|MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
11310912|NCT03170544|BG007|Baseline|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310913|NCT03170544|BG008|Baseline|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092 8 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310914|NCT03170544|BG009|Baseline|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310915|NCT03170544|BG010|Baseline|Part 4 (T2DM) Glargine|Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
11310916|NCT03170544|BG011|Baseline|Part 4 (T2DM) MK-1092|MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
11310917|NCT03170544|BG012|Baseline|Total|Total of all reporting groups
11310918|NCT03170544|FG000|Participant Flow|Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310919|NCT03170544|FG001|Participant Flow|Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310920|NCT03170544|FG002|Participant Flow|Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310921|NCT03170544|FG003|Participant Flow|Part 1 (Healthy Adults) MK-1092 16 Nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310922|NCT03170544|FG004|Participant Flow|Part 1 (Healthy Adults) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310923|NCT03170544|FG005|Participant Flow|Part 1 (Healthy Adults) MK-1092 64 Nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310924|NCT03170544|FG006|Participant Flow|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro|MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
11310925|NCT03170544|FG007|Participant Flow|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310926|NCT03170544|FG008|Participant Flow|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092 SC 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310927|NCT03170544|FG009|Participant Flow|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310928|NCT03170544|FG010|Participant Flow|Part 4 (T2DM) Glargine|Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
11310929|NCT03170544|FG011|Participant Flow|Part 4 (T2DM) MK-1092|MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
11310930|NCT03170544|OG000|Outcome|Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310931|NCT03170544|OG001|Outcome|Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310932|NCT03170544|OG002|Outcome|Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310933|NCT03170544|OG003|Outcome|Part 1 (Healthy Adults) MK-1092 16 Nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310934|NCT03170544|OG004|Outcome|Part 1 (Healthy Adults) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310935|NCT03170544|OG005|Outcome|Part 1 (Healthy Adults) MK-1092 64 Nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310936|NCT03170544|OG006|Outcome|Part 1 (Healthy Adults) Post-trial|Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
11310937|NCT03170544|OG007|Outcome|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro|MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
11310938|NCT03170544|OG008|Outcome|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial|MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
11310939|NCT03170544|OG009|Outcome|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310940|NCT03170544|OG010|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
11310941|NCT03170544|OG011|Outcome|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
11310942|NCT03170544|OG012|Outcome|Part 3 (T1DM) Post-Trial|Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
11310943|NCT03170544|OG013|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
11310944|NCT03170544|OG014|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
11310945|NCT03170544|OG015|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
11310946|NCT03170544|OG016|Outcome|Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310947|NCT03170544|OG017|Outcome|Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310948|NCT03170544|OG018|Outcome|Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310949|NCT03170544|OG019|Outcome|Part 4 (T2DM) Post-Trial|Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
11310950|NCT03170544|OG009|Outcome|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
11310951|NCT03170544|OG010|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM.
11310952|NCT03170544|OG013|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)|Glargine, 3.0 nmol/kg, SC, as a single dose in participants with T2DM in Period 1
11310953|NCT03170544|OG014|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)|Glargine, 3.0 nmol/kg, SC, as a single dose in participants with T2DM in Period 2
11310954|NCT03170544|OG015|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)|Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM in Period 3
11310955|NCT03170544|OG016|Outcome|Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)|MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM
11310956|NCT03170544|OG017|Outcome|Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)|MK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM
11310957|NCT03170544|OG018|Outcome|Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)|MK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM
11310958|NCT03170544|OG000|Outcome|Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310959|NCT03170544|OG001|Outcome|Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310960|NCT03170544|OG002|Outcome|Part 1 (Healthy Adults) MK-1092 16 Nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310961|NCT03170544|OG003|Outcome|Part 1 (Healthy Adults) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310962|NCT03170544|OG004|Outcome|Part 1 (Healthy Adults) MK-1092 64 Nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310963|NCT03170544|OG005|Outcome|Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310964|NCT03170544|OG000|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with Type 1 diabetes mellitus
11310965|NCT03170544|OG001|Outcome|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with Type 1 diabetes mellitus
11310966|NCT03170544|OG002|Outcome|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
11310967|NCT03170544|OG000|Outcome|Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310968|NCT03170544|OG001|Outcome|Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310969|NCT03170544|OG002|Outcome|Part 4 (T2DM) MK-1092 64 Nmol/kg SC (Period 3)|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310970|NCT03170544|OG003|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 1)|Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310971|NCT03170544|OG004|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 2)|Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310972|NCT03170544|OG005|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 3)|Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants with T2DM
11310973|NCT03170544|OG000|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310974|NCT03170544|OG001|Outcome|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310975|NCT03170544|OG000|Outcome|Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310976|NCT03170544|OG002|Outcome|Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310977|NCT03170544|OG003|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)|Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310978|NCT03170544|OG004|Outcome|Part 1 (T2DM) Glargine 3.0 Nmol/kg (Period 2)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310979|NCT03170544|OG005|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310980|NCT03170544|OG005|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310981|NCT03170544|OG006|Outcome|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310982|NCT03170544|OG005|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|Part 3 (Type 1 Diabetes Mellitus) MK-1092 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310983|NCT03170544|OG005|Outcome|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310984|NCT03170544|OG006|Outcome|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310985|NCT03170544|OG002|Outcome|Part 4 (T2MD) MK-1092 64 Nmol/kg (Period 3)|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11310986|NCT03170544|OG001|Outcome|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310987|NCT03170544|OG001|Outcome|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
11310988|NCT03170544|OG000|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
11310989|NCT03170544|OG001|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
11310990|NCT03170544|OG002|Outcome|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
11310991|NCT03170544|EG000|Reported Event|Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310992|NCT03170544|EG001|Reported Event|Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310993|NCT03170544|EG002|Reported Event|Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310994|NCT03170544|EG003|Reported Event|Part 1 (Healthy Adults) MK-1092 16 Nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310995|NCT03170544|EG004|Reported Event|Part 1 (Healthy Adults) MK-1092 32 Nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310996|NCT03170544|EG005|Reported Event|Part 1 (Healthy Adults) MK-1092 64 Nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
11310997|NCT03170544|EG006|Reported Event|Part 1 (Healthy Adults) Post-trial|Glargine or MK-1091 as a single dose under the euglycemic clamp in healthy adults in the Post-trial period
11310998|NCT03170544|EG007|Reported Event|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro|MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
11310999|NCT03170544|EG008|Reported Event|Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-trial|MK-1092, 8.0 nmol/kg selection based on Part 2 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
11311000|NCT03170544|EG009|Reported Event|Part 3 (T1DM) Glargine 3.0 Nmol/kg|Glargine 3.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
11311001|NCT03170544|EG010|Reported Event|Part 3 (T1DM) MK-1092 8.0 Nmol/kg|MK-1092 8.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
11311002|NCT03170544|EG011|Reported Event|Part 3 (T1DM) MK-1092 32 Nmol/kg|MK-1092 32 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
11311003|NCT03170544|EG012|Reported Event|Part 3 (T1DM) Post-trial|Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
11311004|NCT03170544|EG013|Reported Event|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)|Glargine 3.0 nmol/kg, SC, as a single dose under euglycemic clamp in participants with T1DM in Period 1
11311005|NCT03170544|EG014|Reported Event|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
11311006|NCT03170544|EG015|Reported Event|Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)|Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
11311007|NCT03170544|EG016|Reported Event|Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11311008|NCT03170544|EG017|Reported Event|Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
11311009|NCT03170544|EG018|Reported Event|Part 4 (T2DM) 64 Nmol/kg (Period 3)|MK-1092, 64 nmol/kg dose as a single dose under euglycemic clamp in participants with T2DM
11311010|NCT03170544|EG019|Reported Event|Part 4 (T2DM) Post-Trial|Glargine or MK-1092 as a single dose under euglycemic clamp in participants with T2DM in the Post-trial period
11311011|NCT03170609|BG000|Baseline|GBS6 5 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311012|NCT03170609|BG001|Baseline|GBS6 5 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311013|NCT03170609|BG002|Baseline|GBS6 10 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311014|NCT03170609|BG003|Baseline|GBS6 10 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311015|NCT03170609|BG004|Baseline|GBS6 20 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
11311016|NCT03170609|BG005|Baseline|GBS6 20 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311017|NCT03170609|BG006|Baseline|Placebo|Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
11311018|NCT03170609|BG007|Baseline|Total|Total of all reporting groups
11311019|NCT03170609|FG000|Participant Flow|GBS6 5 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311020|NCT03170609|FG001|Participant Flow|GBS6 5 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311021|NCT03170609|FG002|Participant Flow|GBS6 10 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311022|NCT03170609|FG003|Participant Flow|GBS6 10 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311023|NCT03170609|FG004|Participant Flow|GBS6 20 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311024|NCT03170609|FG005|Participant Flow|GBS6 20 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311025|NCT03170609|FG006|Participant Flow|Placebo|Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
11311026|NCT03170609|OG000|Outcome|GBS6 5 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311027|NCT03170609|OG001|Outcome|GBS6 5 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311028|NCT03170609|OG002|Outcome|GBS6 10 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311029|NCT03170609|OG003|Outcome|GBS6 10 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311030|NCT03170609|OG004|Outcome|GBS6 20 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
11311031|NCT03170609|OG005|Outcome|GBS6 20 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311032|NCT03170609|OG006|Outcome|Placebo|Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
11311033|NCT03170609|EG000|Reported Event|GBS6 5 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311034|NCT03170609|EG001|Reported Event|GBS6 5 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311035|NCT03170609|EG002|Reported Event|GBS6 10 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311036|NCT03170609|EG003|Reported Event|GBS6 10 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311037|NCT03170609|EG004|Reported Event|GBS6 20 Microgram With Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
11311038|NCT03170609|EG005|Reported Event|GBS6 20 Microgram Without Aluminum Phosphate|Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
11311039|NCT03170609|EG006|Reported Event|Placebo|Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
11311040|NCT03170661|BG000|Baseline|Moderate Neuromuscular Block|Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.
11311041|NCT03170661|BG001|Baseline|Deep Neuromuscular Block|In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.
11311042|NCT03170661|BG002|Baseline|Total|Total of all reporting groups
11311043|NCT03170661|FG000|Participant Flow|Moderate Neuromuscular Block|Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four
11311044|NCT03170661|FG001|Participant Flow|Deep Neuromuscular Block|"Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count~Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count"
11311045|NCT03170661|OG000|Outcome|Moderate Neuromuscular Block|Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four
11311046|NCT03170661|OG001|Outcome|Deep Neuromuscular Block|"Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count~Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count"
11311047|NCT03170661|OG000|Outcome|Moderate Neuromuscular Block|Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.
11311048|NCT03170661|OG001|Outcome|Deep Neuromuscular Block|In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.
11311049|NCT03170661|EG000|Reported Event|Moderate NMB|Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.
11311050|NCT03170661|EG001|Reported Event|Deep NMB|In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.
11333154|NCT03509974|FG000|Participant Flow|Bone Anchored Hearing Device (OSIA)|"All subjects will receive the Bone Anchored Hearing Device (OSIA)~Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system"
11311051|NCT03171051|BG000|Baseline|Lipolysis Treatment|"The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. No baseline temperatures were obtained.~The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. No baseline temperatures were obtained."
11311052|NCT03171051|FG000|Participant Flow|Lipolysis Treatment|"The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.~The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body."
11311053|NCT03171051|OG000|Outcome|Lipolysis Treatment|"The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.~The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body."
11311054|NCT03171051|OG000|Outcome|Treatment Group|Subjects received two lipolysis treatments: the left flank of the abdomen received treatment with the diode laser device and the right flank of the abdomen received treatment with the LED device.
11311055|NCT03171051|EG000|Reported Event|Lipolysis Treatment|"The right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes.~950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.~1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body."
11311056|NCT03171415|BG000|Baseline|RZL-012 Cohort 1|"A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat."
11311057|NCT03171415|BG001|Baseline|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16(0.1mL per site) into the abdominal subcutaneous fat."
11311058|NCT03171415|BG002|Baseline|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24(0.1mL per site) into the abdominal subcutaneous fat."
11311059|NCT03171415|BG003|Baseline|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36(0.1mL per site) into the abdominal subcutaneous fat."
11311060|NCT03171415|BG004|Baseline|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)~Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat."
11311061|NCT03171415|BG005|Baseline|Total|Total of all reporting groups
11311062|NCT03171415|FG000|Participant Flow|RZL-012 Cohort 1|"A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat."
11311063|NCT03171415|FG001|Participant Flow|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat."
11311064|NCT03171415|FG002|Participant Flow|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat."
11311065|NCT03171415|FG003|Participant Flow|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat."
11311066|NCT03171415|FG004|Participant Flow|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat."
11333155|NCT03509974|OG000|Outcome|Bone Anchored Hearing Device (OSIA)|"All subjects will receive the Bone Anchored Hearing Device (OSIA)~Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system"
11311067|NCT03171415|OG000|Outcome|RZL-012 Cohort 1|"A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):~RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat."
11311068|NCT03171415|OG001|Outcome|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311069|NCT03171415|OG002|Outcome|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311070|NCT03171415|OG003|Outcome|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311071|NCT03171415|OG004|Outcome|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)~Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat."
11311072|NCT03171415|OG000|Outcome|RZL-012 Cohort 1|"A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat."
11311073|NCT03171415|OG001|Outcome|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat."
11311074|NCT03171415|OG002|Outcome|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat."
11311075|NCT03171415|OG003|Outcome|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat."
11311076|NCT03171415|OG004|Outcome|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat."
11311077|NCT03171415|OG000|Outcome|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311078|NCT03171415|OG001|Outcome|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)~Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat."
11311079|NCT03171415|OG000|Outcome|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311080|NCT03171415|OG001|Outcome|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11333156|NCT03509974|EG000|Reported Event|Bone Anchored Hearing Device (OSIA)|"All subjects will receive the Bone Anchored Hearing Device (OSIA)~Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system"
11333157|NCT03510182|BG000|Baseline|Transcranial Direct Current Stimulation|"tDCS will be given to all qualified patients with aphasia.~transcranial direct current stimulation"
11333158|NCT03510182|FG000|Participant Flow|Transcranial Direct Current Stimulation|"tDCS will be given to all qualified patients with aphasia.~transcranial direct current stimulation"
11333159|NCT03510182|OG000|Outcome|Transcranial Direct Current Stimulation|"tDCS will be given to all qualified patients with aphasia.~transcranial direct current stimulation"
11333160|NCT03510182|EG000|Reported Event|Transcranial Direct Current Stimulation|"tDCS will be given to all qualified patients with aphasia.~transcranial direct current stimulation"
11333161|NCT03510195|BG000|Baseline|Sociodemographic Factors of Participants|Data and results obtained from pre-intervention, post intervention and 1 month after work post intervention
11311081|NCT03171415|OG002|Outcome|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat."
11311082|NCT03171415|OG003|Outcome|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)~Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat."
11311083|NCT03171415|EG000|Reported Event|RZL-012 Cohort 1|"A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat."
11311084|NCT03171415|EG001|Reported Event|RZL-012 Cohort 2|"A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat."
11311085|NCT03171415|EG002|Reported Event|RZL-012 Cohort 3|"A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat."
11311086|NCT03171415|EG003|Reported Event|RZL-012 Cohort 4|"A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat."
11311087|NCT03171415|EG004|Reported Event|Placebo|"A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):~Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat."
11311088|NCT03172130|BG000|Baseline|Straight CPAP|"Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Straight CPAP"
11311089|NCT03172130|BG001|Baseline|Sham CPAP|"Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Sham CPAP"
11311090|NCT03172130|BG002|Baseline|Total|Total of all reporting groups
11311091|NCT03172130|FG000|Participant Flow|Straight CPAP|"Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Straight CPAP"
11311092|NCT03172130|FG001|Participant Flow|Sham CPAP|"Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Sham CPAP"
11311093|NCT03172130|OG000|Outcome|Straight CPAP|"Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Straight CPAP"
11311094|NCT03172130|OG001|Outcome|Sham CPAP|"Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Sham CPAP"
11311095|NCT03172130|EG000|Reported Event|Straight CPAP|"Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Straight CPAP"
11311096|NCT03172130|EG001|Reported Event|Sham CPAP|"Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.~Sham CPAP"
11311097|NCT03172325|BG000|Baseline|CinnaGen Adalimumab|"CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311098|NCT03172325|BG001|Baseline|AbbVie Adalimumab|"Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311099|NCT03172325|BG002|Baseline|Total|Total of all reporting groups
11311100|NCT03172325|FG000|Participant Flow|CinnaGen Adalimumab|"CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311101|NCT03172325|FG001|Participant Flow|AbbVie Adalimumab|"Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311102|NCT03172325|OG000|Outcome|CinnaGen Adalimumab|"CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311103|NCT03172325|OG001|Outcome|AbbVie Adalimumab|"Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311104|NCT03172325|EG000|Reported Event|CinnaGen Adalimumab|"CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311105|NCT03172325|EG001|Reported Event|AbbVie Adalimumab|"Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.~Adalimumab: 40 mg Adalimumab every other week is administered subcutaneously to all the patients.~Methotrexate: 15 mg Methotrexate is weekly administered to all the patients.~Folic Acid: At least 1 mg Folic acid is daily administered to all the patients.~Prednisolone: 7.5 mg Prednisolone is daily administered to all the patients."
11311106|NCT03172364|BG000|Baseline|Test Product 1|All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311107|NCT03172364|BG001|Baseline|Test Product 2|All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311108|NCT03172364|BG002|Baseline|Total|Total of all reporting groups
11311109|NCT03172364|FG000|Participant Flow|Test Product 1|All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311110|NCT03172364|FG001|Participant Flow|Test Product 2|All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311111|NCT03172364|OG000|Outcome|Test Product 1|All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311112|NCT03172364|OG001|Outcome|Test Product 2|All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311113|NCT03172364|EG000|Reported Event|Test Product 1|All the participants in this arm will receive test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311114|NCT03172364|EG001|Reported Event|Test Product 2|All the participants in this arm will receive test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
11311115|NCT03172481|BG000|Baseline|PRC-063|"PRC-063 25, 35, 45, 55, 70 or 85 mg~PRC-063 oral capsules: Daily dose"
11311116|NCT03172481|BG001|Baseline|Placebo|Placebo oral capsules: Daily dose
11311117|NCT03172481|BG002|Baseline|Total|Total of all reporting groups
11311118|NCT03172481|FG000|Participant Flow|PRC-063|"PRC-063 25, 35, 45, 55, 70 or 85 mg~PRC-063 oral capsules: Daily dose"
11311119|NCT03172481|FG001|Participant Flow|Placebo|Placebo oral capsules: Daily dose
11311120|NCT03172481|OG000|Outcome|PRC-063|"PRC-063 25, 35, 45, 55, 70 or 85 mg~PRC-063 oral capsules: Daily dose"
11311121|NCT03172481|OG001|Outcome|Placebo|Placebo oral capsules: Daily dose
11311122|NCT03172481|EG000|Reported Event|PRC-063|"PRC-063 25, 35, 45, 55, 70 or 85 mg~PRC-063 oral capsules: Daily dose"
11311123|NCT03172481|EG001|Reported Event|Placebo|Placebo oral capsules: Daily dose
11311124|NCT03172494|BG000|Baseline|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311125|NCT03172494|BG001|Baseline|Insulin Degludec|Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.
11311126|NCT03172494|BG002|Baseline|Liraglutide|"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
11311127|NCT03172494|BG003|Baseline|Total|Total of all reporting groups
11311128|NCT03172494|FG000|Participant Flow|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 milligrams (mg) liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 millimoles/litre (mmol/L). The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311129|NCT03172494|FG001|Participant Flow|Insulin Degludec|Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.
11311130|NCT03172494|FG002|Participant Flow|Liraglutide|"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg per day (mg/day) was continued for the remaining period of treatment."
11311131|NCT03172494|OG000|Outcome|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311132|NCT03172494|OG001|Outcome|Insulin Degludec|Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.
11311133|NCT03172494|OG002|Outcome|Liraglutide|"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
11311134|NCT03172494|OG001|Outcome|Liraglutide|"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
11311135|NCT03172494|EG000|Reported Event|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311136|NCT03172494|EG001|Reported Event|Insulin Degludec|Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.
11311137|NCT03172494|EG002|Reported Event|Liraglutide|"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
11311138|NCT03172702|BG000|Baseline|Sodium Zirconium Cyclosilicate|"CP (up to 3 days):~Patients received 10 g ZS TID for a maximum of 72 hours.~MP (up to 12 months):~Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD."
11311139|NCT03172702|FG000|Participant Flow|Sodium Zirconium Cyclosilicate|"CP (up to 3 days):~Patients received 10 grams (g) ZS three times daily (TID) for a maximum of 72 hours. If a patient became normokalemic (iSTAT potassium ≥3.5 and ≤5.0 mmol/L) after 24, 48 or 72 hours they progressed to the Maintenance Phase (MP).~MP (up to 12 months):~Patients received a starting dose of 5 g ZS once daily (QD) and based on the iSTAT potassium measurements the ZS dose could be increased to 10 g or 15 g QD or decreased to 5 g once every other day (QOD) or 2.5 g QD."
11311140|NCT03172702|OG000|Outcome|Sodium Zirconium Cyclosilicate|"CP (up to 3 days):~Patients received 10 g ZS TID for a maximum of 72 hours.~MP (up to 12 months):~Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD."
11311141|NCT03172702|EG000|Reported Event|Correction Phase|"CP (up to 3 days):~Patients received 10 g ZS TID for a maximum of 72 hours."
11311142|NCT03172702|EG001|Reported Event|Maintenance Phase|"MP (up to 12 months):~Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD."
11311143|NCT03172884|BG000|Baseline|Moderate Hepatic Impairment Group|Child-Pugh B (score 7-9) at the screening visit
11311144|NCT03172884|BG001|Baseline|Severe Hepatic Impairment Group|Child-Pugh C (score 10-15) at the screening visit
11311145|NCT03172884|BG002|Baseline|Severe Renal Impairment Group|eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation
11311146|NCT03172884|BG003|Baseline|Healthy Participants|Normal hepatic and renal function group
11311147|NCT03172884|BG004|Baseline|Total|Total of all reporting groups
11311148|NCT03172884|FG000|Participant Flow|Moderate Hepatic Impairment Group|Child-Pugh B (score 7-9) at the screening visit
11311149|NCT03172884|FG001|Participant Flow|Severe Hepatic Impairment Group|Child-Pugh C (score 10-15) at the screening visit
11311150|NCT03172884|FG002|Participant Flow|Severe Renal Impairment Group|eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation
11311151|NCT03172884|FG003|Participant Flow|Healthy Participants|Normal hepatic and renal function group
11311152|NCT03172884|OG000|Outcome|Moderate Hepatic Impairment Group|Child-Pugh B (score 7-9) at the screening visit
11311153|NCT03172884|OG001|Outcome|Severe Hepatic Impairment Group|Child-Pugh C (score 10-15) at the screening visit
11311154|NCT03172884|OG002|Outcome|Severe Renal Impairment Group|eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation
11311155|NCT03172884|OG003|Outcome|Healthy Participants|Normal hepatic and renal function group
11311156|NCT03172884|EG000|Reported Event|Moderate Hepatic Impairment Group|Subjects with Child-Pugh B (score 7-9) at the screening visit.
11311157|NCT03172884|EG001|Reported Event|Severe Hepatic Impairment Group|Child-Pugh C (score 10-15) at the screening visit
11311158|NCT03172884|EG002|Reported Event|Severe Renal Impairment Group|eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation
11311159|NCT03172884|EG003|Reported Event|Healthy Participants|Normal hepatic and renal function group
11311160|NCT03173170|BG000|Baseline|TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
11311161|NCT03173170|FG000|Participant Flow|TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
11311162|NCT03173170|OG000|Outcome|TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period.
11311163|NCT03173170|OG001|Outcome|Itraconazole 200 mg and TAK-954 0.2 mg|Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
11311164|NCT03173170|OG001|Outcome|Itraconazole 200 mg and TAK-954 0.2mg|Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
11311165|NCT03173170|EG000|Reported Event|TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period.
11311166|NCT03173170|EG001|Reported Event|Itraconazole 200 mg|Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 3 of Second Intervention Period.
11311167|NCT03173170|EG002|Reported Event|Itraconazole 200 mg and TAK-954 0.2 mg|Itraconazole 200 mg, capsule, orally, once daily on Days 4 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
11311168|NCT03173313|BG000|Baseline|Cooling + PCI|"The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311169|NCT03173313|BG001|Baseline|PCI Only|"The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311170|NCT03173313|BG002|Baseline|Total|Total of all reporting groups
11311171|NCT03173313|FG000|Participant Flow|Cooling + PCI|"The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311172|NCT03173313|FG001|Participant Flow|PCI Only|"The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311173|NCT03173313|OG000|Outcome|Cooling + PCI|"The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311174|NCT03173313|OG001|Outcome|PCI Only|"The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311175|NCT03173313|EG000|Reported Event|Cooling + PCI|"The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311176|NCT03173313|EG001|Reported Event|PCI Only|"The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.~Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI"
11311177|NCT03173547|BG000|Baseline|146-9251 Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~146-9251 cream: 146-9251 cream contains an active drug and is applied topically."
11311178|NCT03173547|BG001|Baseline|Vehicle Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~Vehicle cream: Vehicle cream does not contain an active drug and is applied topically."
11311179|NCT03173547|BG002|Baseline|Total|Total of all reporting groups
11311180|NCT03173547|FG000|Participant Flow|146-9251 Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~146-9251 cream: 146-9251 cream contains an active drug and is applied topically."
11311181|NCT03173547|FG001|Participant Flow|Vehicle Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~Vehicle cream: Vehicle cream does not contain an active drug and is applied topically."
11311182|NCT03173547|OG000|Outcome|146-9251 Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~146-9251 cream: 146-9251 cream contains an active drug and is applied topically."
11311183|NCT03173547|OG001|Outcome|Vehicle Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~Vehicle cream: Vehicle cream does not contain an active drug and is applied topically."
11311184|NCT03173547|EG000|Reported Event|146-9251 Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~146-9251 cream: 146-9251 cream contains an active drug and is applied topically."
11311185|NCT03173547|EG001|Reported Event|Vehicle Cream|"Topical cream to be applied two times daily to specified treatment areas for 6 weeks.~Vehicle cream: Vehicle cream does not contain an active drug and is applied topically."
11311186|NCT03173560|BG000|Baseline|Lenvatinib 14 mg + Everolimus 5 mg|Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any >=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.
11311187|NCT03173560|BG001|Baseline|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
11311188|NCT03173560|BG002|Baseline|Total|Total of all reporting groups
11311189|NCT03173560|FG000|Participant Flow|Lenvatinib 14 mg + Everolimus 5 mg|Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any greater than or equal to (>=) Grade 3 treatment-emergent adverse events (TEAEs) that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length equals to (=) 28 days) during randomization phase.
10842472|NCT00246571|EG001|Reported Event|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
11311190|NCT03173560|FG001|Participant Flow|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
11311191|NCT03173560|OG000|Outcome|Lenvatinib 14 mg + Everolimus 5 mg|Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any >=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.
11311192|NCT03173560|OG001|Outcome|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
11311193|NCT03173560|EG000|Reported Event|Lenvatinib 14 mg + Everolimus 5 mg|Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. If there were no intolerable Grade 2 or any >= Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), lenvatinib dose was escalated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length = 28 days) during randomization phase.
11311194|NCT03173560|EG001|Reported Event|Lenvatinib 18 mg + Everolimus 5 mg|Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
11311195|NCT03174132|BG000|Baseline|Restylane Perlane Lidocaine and Restylane Perlane|"Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1~Restylane Perlane Lidocaine: Intradermal injection~Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1~Restylane Perlane: Intradermal injection"
11311196|NCT03174132|FG000|Participant Flow|Restylane Perlane Lidocaine and Restylane Perlane|"Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1~Restylane Perlane Lidocaine: Intradermal injection~Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1~Restylane Perlane: Intradermal injection"
11311197|NCT03174132|OG000|Outcome|Restylane Perlane Lidocaine and Restylane Perlane|"Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1~Restylane Perlane Lidocaine: Intradermal injection~Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1~Restylane Perlane: Intradermal injection"
11311198|NCT03174132|EG000|Reported Event|Restylane Perlane Lidocaine and Restylane Perlane|"Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1~Restylane Perlane Lidocaine: Intradermal injection~Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1~Restylane Perlane: Intradermal injection"
11311199|NCT03174158|BG000|Baseline|Brief Advice|Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
11311200|NCT03174158|BG001|Baseline|Text Messaging|"Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311201|NCT03174158|BG002|Baseline|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311202|NCT03174158|BG003|Baseline|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311203|NCT03174158|BG004|Baseline|Total|Total of all reporting groups
11311204|NCT03174158|FG000|Participant Flow|Brief Advice|Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
11311205|NCT03174158|FG001|Participant Flow|Text Messaging|"Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311206|NCT03174158|FG002|Participant Flow|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311207|NCT03174158|FG003|Participant Flow|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311208|NCT03174158|OG000|Outcome|Brief Advice|"Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311209|NCT03174158|OG001|Outcome|Text Messaging|"Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311210|NCT03174158|OG002|Outcome|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311211|NCT03174158|OG003|Outcome|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311212|NCT03174158|OG000|Outcome|Brief Advice|Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
11311213|NCT03174158|OG001|Outcome|Text Messaging|"Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311214|NCT03174158|OG002|Outcome|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311215|NCT03174158|OG003|Outcome|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311216|NCT03174158|OG000|Outcome|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311217|NCT03174158|OG001|Outcome|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311218|NCT03174158|OG002|Outcome|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311219|NCT03174158|OG003|Outcome|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training"
11311220|NCT03174158|EG000|Reported Event|Brief Advice|Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
11311221|NCT03174158|EG001|Reported Event|Text Messaging|"Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311222|NCT03174158|EG002|Reported Event|Mailed Nicotine Replacement Therapy|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11333162|NCT03510195|FG000|Participant Flow|Participants in Medicorp HO Preparatory Module|A total of 267 participants registered for the course and were invited to participate within the timeframe of this study period of recruitment. Only 239 returned their baseline questionnaires. At the time-point immediately after the intervention, 224 participants returned their completed questionnaires. At the subsequent follow up of the study, which was one-month post working as a HO, 101 answered the questionnaire.
11311223|NCT03174158|EG003|Reported Event|Text Messaging + Mailed NRT|"Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.~Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.~Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training"
11311224|NCT03174366|BG000|Baseline|Intervention Group, Receiving Medication|"Subjects in this group will be receiving medication (denosumab)~Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter."
11311225|NCT03174366|FG000|Participant Flow|Intervention Group, Receiving Medication|"Subjects in this group will be receiving medication (denosumab)~Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter."
11311226|NCT03174366|OG000|Outcome|Intervention Group, Receiving Medication|"Subjects in this group will be receiving medication (denosumab)~Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter."
11311227|NCT03174366|EG000|Reported Event|Intervention Group, Receiving Medication|"Subjects in this group will be receiving medication (denosumab)~Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter."
11311228|NCT03174925|BG000|Baseline|Tissue Stiffness by Elastography|"Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.~Siemens Acuson S3000 ultrasound system: Shear Wave Elastography"
11311229|NCT03174925|FG000|Participant Flow|Tissue Stiffness by Elastography|"Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.~Siemens Acuson S3000 ultrasound system: Shear Wave Elastography"
11311230|NCT03174925|OG000|Outcome|Tissue Stiffness by Elastography|"Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.~Siemens Acuson S3000 ultrasound system: Shear Wave Elastography"
11311231|NCT03174925|EG000|Reported Event|Tissue Stiffness by Elastography|"Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.~Siemens Acuson S3000 ultrasound system: Shear Wave Elastography"
11311232|NCT03175120|BG000|Baseline|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311233|NCT03175120|BG001|Baseline|Insulin Degludec|Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.
11311234|NCT03175120|BG002|Baseline|Total|Total of all reporting groups
11311235|NCT03175120|FG000|Participant Flow|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311236|NCT03175120|FG001|Participant Flow|Insulin Degludec|Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.
11311237|NCT03175120|OG000|Outcome|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311238|NCT03175120|OG001|Outcome|Insulin Degludec|Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.
11333163|NCT03510195|OG000|Outcome|Pre-intervention|The participants assessed before the preparatory course started.
11333164|NCT03510195|OG001|Outcome|Post-intervention|The participant assessed after the preparatory course ended.
11333165|NCT03510195|OG002|Outcome|Post 1 Month Working|The participant assessed after 1 month working.
11333166|NCT03510195|OG000|Outcome|Pre-intervention Level of Readiness|The participants assessed before the preparatory course started.
11333167|NCT03510195|OG001|Outcome|Post Intervention Level of Readiness|The participants assessed after the preparatory course ended.
11333168|NCT03510195|OG000|Outcome|Pre-intervention DASS-depression|The participant assessed before the preparatory course started via DASS questionnaire.
11333169|NCT03510195|OG001|Outcome|Post 1 Month Working DASS-depression|The participants assessed after the preparatory course ended via DASS questionnaire.
11333170|NCT03510195|OG000|Outcome|Pre-intervention DASS-anxiety|The participants assessed before the preparatory course via DASS questionnaire.
11333171|NCT03510195|OG001|Outcome|Post 1 Month Working DASS-anxiety|The participants assessed 1 month after working via DASS questionnaire.
11333172|NCT03510195|OG000|Outcome|Pre-intervention DASS-stress|The participants assessed before the preparatory course via DASS questionnaire.
11311239|NCT03175120|EG000|Reported Event|Insulin Degludec/Liraglutide|Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.
11311240|NCT03175120|EG001|Reported Event|Insulin Degludec|Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.
11311241|NCT03175172|BG000|Baseline|Experimental|CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by IV infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 CFU) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).
11311242|NCT03175172|FG000|Participant Flow|Experimental|CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by intravenous (IV) infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 colony forming units [CFU]) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).
11311243|NCT03175172|OG000|Outcome|Experimental|CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by IV infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 CFU) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).
11311244|NCT03175172|EG000|Reported Event|Experimental|CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by IV infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 CFU) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).
11311245|NCT03175562|BG000|Baseline|Overall Participants|All the participants who received any application of study products were included for baseline evaluation
11311246|NCT03175562|FG000|Participant Flow|All Participants|Included all participants who were randomized to receive the study treatment. In this study, the test product and the negative control (saline solution) were randomly applied to 2 different cells in a single semi-occlusive patch that was applied on a subject's dorsum.
11311247|NCT03175562|OG000|Outcome|Test Product|This arm included data from all the test sites were test product was applied.
11311248|NCT03175562|OG001|Outcome|Reference Product|This arm included data from all the test sites were negative control was applied.
11311249|NCT03175562|OG001|Outcome|Negative Control|This arm included data from all the test sites were negative control was applied.
11311250|NCT03175562|OG001|Outcome|Reference Control|This arm included data from all the test sites were negative control was applied.
11311251|NCT03175562|EG000|Reported Event|All Participants|Safety population (N=240), the Safety population included all participants who received any application of the study products.
11311252|NCT03175731|BG000|Baseline|Proton Pump Inhibitors|"Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311253|NCT03175731|BG001|Baseline|Placebo|"Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311254|NCT03175731|BG002|Baseline|Total|Total of all reporting groups
11311255|NCT03175731|FG000|Participant Flow|Proton Pump Inhibitors|"Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311256|NCT03175731|FG001|Participant Flow|Placebo|"Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311257|NCT03175731|OG000|Outcome|Proton Pump Inhibitors|"Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311258|NCT03175731|OG001|Outcome|Placebo|"Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311259|NCT03175731|EG000|Reported Event|Proton Pump Inhibitors|"Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311260|NCT03175731|EG001|Reported Event|Placebo|"Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.~Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment."
11311261|NCT03176238|BG000|Baseline|Asian Everolimus + Exemestane|Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
11311262|NCT03176238|BG001|Baseline|Non-Asian Everolimus + Exemestane|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
11311263|NCT03176238|BG002|Baseline|Total|Total of all reporting groups
11333173|NCT03510195|OG001|Outcome|Post 1 Month Working DASS-stress|The participants assessed 1 month after working via DASS questionnaire.
11311264|NCT03176238|FG000|Participant Flow|Asian Everolimus + Exemestane|Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
11311265|NCT03176238|FG001|Participant Flow|Non-Asian Everolimus + Exemestane|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
11311266|NCT03176238|OG000|Outcome|Asian Everolimus + Exemestane|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
11311267|NCT03176238|OG001|Outcome|Non-Asian Everolimus + Exemestane|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
11311268|NCT03176238|OG002|Outcome|Total|Asian and Non -Asian countries
11311269|NCT03176238|OG002|Outcome|Total|Asian and Non-Asianb
11311270|NCT03176238|OG000|Outcome|Asian Everolimus and Exemestane|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan
11311271|NCT03176238|OG002|Outcome|Total|Asian and Non-Asian countries
11311272|NCT03176238|EG000|Reported Event|Asian|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
11311273|NCT03176238|EG001|Reported Event|Non-Asian|Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
11311274|NCT03176407|BG000|Baseline|HemoPill Acute|"Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours.~Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days."
11311275|NCT03176407|FG000|Participant Flow|HemoPill Acute|There was only one study arm as all patients swallowed the sensor capsule.
11311276|NCT03176407|OG000|Outcome|HemoPill Acute|Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.
11311277|NCT03176407|OG000|Outcome|HemoPill Acute|"When capsule is swallowed by the patient an external study receiver records the capsule sensor data for 4 consecutive hours.~After capsule application capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.~Capsule readout is performed by the sponsor."
11311278|NCT03176407|OG000|Outcome|HemoPill Acute|Capsule is swallowed by the patients themselves. Patient takes the capsule in their hands and put it in their mouth and swallow it by themselves.
11311279|NCT03176407|EG000|Reported Event|HemoPill Acute|Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.
11311280|NCT03176459|BG000|Baseline|EXPAREL 266mg + Immediate Release (IR) Bupivacaine|60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.
11311281|NCT03176459|BG001|Baseline|IR Bupivacaine|60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
11311282|NCT03176459|BG002|Baseline|Total|Total of all reporting groups
11311283|NCT03176459|FG000|Participant Flow|EXPAREL 266mg + Immediate Release (IR) Bupivacaine|60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.
11311284|NCT03176459|FG001|Participant Flow|IR Bupivacaine|60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
11311285|NCT03176459|OG000|Outcome|EXPAREL 266mg + Immediate Release (IR) Bupivacaine|60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.
11311286|NCT03176459|OG001|Outcome|IR Bupivacaine|60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
11311287|NCT03176459|EG000|Reported Event|EXPAREL+Bupivacaine TAP Infiltration|"Receive a single 20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL.~Exparel + Bupivacaine: EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®."
11311288|NCT03176459|EG001|Reported Event|Active Bupivacaine TAP Infiltration|"Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL~Bupivacaine: Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures."
11311289|NCT03176654|BG000|Baseline|HVLAT Manipulation|"An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae.~HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw."
11311290|NCT03176654|BG001|Baseline|Sham HVLAT Manipulation|"Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure.~Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw."
11311291|NCT03176654|BG002|Baseline|Total|Total of all reporting groups
11311292|NCT03176654|FG000|Participant Flow|HVLAT Manipulation|"An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae.~HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw."
11311293|NCT03176654|FG001|Participant Flow|Sham HVLAT Manipulation|"Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure.~Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw."
11311294|NCT03176654|OG000|Outcome|HVLAT Manipulation|"An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae.~HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw."
11311295|NCT03176654|OG001|Outcome|Sham HVLAT Manipulation|"Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure.~Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw."
11311296|NCT03176654|EG000|Reported Event|HVLAT Manipulation|"An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae.~HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw."
11311297|NCT03176654|EG001|Reported Event|Sham HVLAT Manipulation|"Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure.~Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw."
11311298|NCT03176784|BG000|Baseline|Varenicline + Patch Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Nicotine Patches:~Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311299|NCT03176784|BG001|Baseline|Varenicline Only Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311300|NCT03176784|BG002|Baseline|Varenicline + Patch Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Nicotine Patches:~14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations."
11311301|NCT03176784|BG003|Baseline|Varenicline Only Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations."
11311302|NCT03176784|BG004|Baseline|Total|Total of all reporting groups
11311303|NCT03176784|FG000|Participant Flow|Varenicline + Patch Standard Duration|"Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Nicotine Patches:~Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311304|NCT03176784|FG001|Participant Flow|Varenicline Only Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311305|NCT03176784|FG002|Participant Flow|Varenicline + Patch Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Nicotine Patches:~14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations."
11311306|NCT03176784|FG003|Participant Flow|Varenicline Only Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations."
11311307|NCT03176784|OG000|Outcome|Varenicline + Patch Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Nicotine Patches:~Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11333174|NCT03510195|EG000|Reported Event|Participants in Medicorp HO Preparatory Module|"Pre-intervention: The participants screened based on the exclusion and inclusion criteria leaving the number of 239 participants after registration.~Post-intervention: Drop outs mainly due to failure in submitting the complete post-intervention questionnaires before they headed home.~Post 1 month after work: Major drop outs purely as a result of unavailability to answer and time constraint due to the hectic schedule of a houseman."
11333175|NCT03510273|BG000|Baseline|Thermocoagulation Treatment|Received thermal coagulation treatment for cervical precancer.
11311308|NCT03176784|OG001|Outcome|Varenicline Only Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311309|NCT03176784|OG002|Outcome|Varenicline + Patch Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Nicotine Patches:~14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations."
11311310|NCT03176784|OG003|Outcome|Varenicline Only Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations."
11333176|NCT03510273|FG000|Participant Flow|Thermocoagulation Treatment|Received thermal coagulation treatment for cervical precancer.
11333177|NCT03510273|OG000|Outcome|Thermocoagulation Treatment|Received thermal coagulation treatment for cervical precancer.
11333178|NCT03510273|OG000|Outcome|CIN2-3 at Baseline|Biopsy positive at baseline
11333179|NCT03510273|OG001|Outcome|< CIN2 at Baseline|Biopsy negative at baseline
11333180|NCT03510273|OG000|Outcome|Evidence of Treatment Failure|Women with CIN2-3 at baseline and CIN2-3 at 12 months
11333181|NCT03510273|OG001|Outcome|No Evidence of Treatment Failure|Women with CIN2-3 at baseline and <CIN2 at 12 months
11333182|NCT03510273|EG000|Reported Event|Thermocoagulation Treatment|Received thermal coagulation treatment for cervical precancer.
11333183|NCT03510455|BG000|Baseline|Single Arm (TIO Subjects)|"Phase 2, open-label, non-randomized, single-arm, drug treatment trial. 10 subjects will be studied. Treatment duration of 6 months with 3 months off drug follow-up and optional extension phase.~BGJ398: BGJ398, a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor will be orally administered over six 4-week cycles (3 weeks on drug, 1 week off drug). After the initial dose, escalation/de- escalation of BGJ398 will be based on FGF- 23 blood levels and adjusted according to protocol procedures. The six cycles of BGJ398 will be followed by 3 months off the drug and an optional extension phase."
11333184|NCT03510455|FG000|Participant Flow|TIO Subjects Who Received BGJ398 (Single Arm)|TIO subjects were treated with BGJ398 for 24 weeks with optional extension phase
11333185|NCT03510455|OG000|Outcome|TIO Subjects Who Received BGJ398 (Single Arm)|TIO subjects were treated with BGJ398 for 24 weeks with optional extension phase
11333186|NCT03510455|OG000|Outcome|Single Arm (TIO Subjects)|"Phase 2, open-label, non-randomized, single-arm, drug treatment trial. 10 subjects will be studied. Treatment duration of 6 months with 3 months off drug follow-up and optional extension phase.~BGJ398: BGJ398, a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor will be orally administered over six 4-week cycles (4 weeks on drug continuously). After the initial dose, escalation/de- escalation of BGJ398 will be based on FGF- 23 blood levels and adjusted according to protocol procedures. The six cycles of BGJ398 will be followed by 3 months off the drug and an optional extension phase."
11333187|NCT03510455|OG000|Outcome|TIO Subjects With Radiographic Evidence of TIO Who Received BGJ398 (Single Arm)|TIO subjects with radiographic evidence of TIO were treated with BGJ398 for 24 weeks with optional extension phase. FDG-PET imaging was performed at baseline and at week 24.
11333188|NCT03510455|EG000|Reported Event|TIO Subjects Who Received BGJ398 (Single Arm)|TIO subjects were treated with BGJ398 for 24 weeks with optional extension phase
11333189|NCT03510481|BG000|Baseline|Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333190|NCT03510481|BG001|Baseline|Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333191|NCT03510481|BG002|Baseline|Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks|Control for Arm 1. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333192|NCT03510481|BG003|Baseline|Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks|Control for Arm 2. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11311311|NCT03176784|EG000|Reported Event|Varenicline + Patch Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Nicotine Patches:~Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311312|NCT03176784|EG001|Reported Event|Varenicline Only Standard Duration|"Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID~Standard Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.~Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)"
11311313|NCT03176784|EG002|Reported Event|Varenicline + Patch Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Nicotine Patches:~14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations."
11311314|NCT03176784|EG003|Reported Event|Varenicline Only Extended Duration|"Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22~Extended Condition Placebo Patches:~Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit~Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)~Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations."
11311315|NCT03177395|BG000|Baseline|Acetylcysteine (N-acetylcysteine; NAC)|NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.
11311316|NCT03177395|BG001|Baseline|Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (2 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311317|NCT03177395|BG002|Baseline|Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311318|NCT03177395|BG003|Baseline|Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~• Group B: PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 (10 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311319|NCT03177395|BG004|Baseline|Total|Total of all reporting groups
11311320|NCT03177395|FG000|Participant Flow|Acetylcysteine (N-acetylcysteine; NAC)|NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.
10842473|NCT00246740|BG000|Baseline|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
11311321|NCT03177395|FG001|Participant Flow|Group A: PP100-01 (Calmangafodipir 2 μmol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (2 μmol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes."
11311322|NCT03177395|FG002|Participant Flow|Group B: PP100-01 (Calmangafodipir 5 μmol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 μmol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes."
11311323|NCT03177395|FG003|Participant Flow|Group C: PP100-01 (Calmangafodipir 10 μmol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (10 μmol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes."
11311324|NCT03177395|OG000|Outcome|Acetylcysteine (N-acetylcysteine; NAC)|NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.
11311325|NCT03177395|OG001|Outcome|Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (2 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11333193|NCT03510481|BG004|Baseline|Total|Total of all reporting groups
11311326|NCT03177395|OG002|Outcome|Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~Group A: PP100-01 (2 umol/kg calmangafodipir) after the loading dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~Group C: PP100-01 (10 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311327|NCT03177395|OG003|Outcome|Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (10 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311328|NCT03177395|OG002|Outcome|Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311329|NCT03177395|OG003|Outcome|Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 (10 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311330|NCT03177395|EG000|Reported Event|Acetylcysteine (N-acetylcysteine; NAC)|NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.
11311331|NCT03177395|EG001|Reported Event|Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (2 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311332|NCT03177395|EG002|Reported Event|Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311333|NCT03177395|EG003|Reported Event|Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC|"In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:~PP100-01 (5 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 (10 umol/kg calmangafodipir) after the loading dose of NAC~PP100-01 treatment is administered intravenously over 5 minutes.~PP100-01 (calmangafodipir): PP100-01"
11311334|NCT03177512|BG000|Baseline|LYNX Mobile App|LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
11311335|NCT03177512|BG001|Baseline|Control|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311336|NCT03177512|BG002|Baseline|Total|Total of all reporting groups
11311337|NCT03177512|FG000|Participant Flow|LYNX Mobile App|LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
11311338|NCT03177512|FG001|Participant Flow|Control|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311339|NCT03177512|OG000|Outcome|LYNX Mobile App|LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
11311340|NCT03177512|OG001|Outcome|Control|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311341|NCT03177512|EG000|Reported Event|LYNX Mobile App|LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
11311342|NCT03177512|EG001|Reported Event|Control|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311343|NCT03177603|BG000|Baseline|GSK2586881 0.1 mg/kg|Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311344|NCT03177603|BG001|Baseline|GSK2586881 0.2 mg/kg|Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311345|NCT03177603|BG002|Baseline|GSK2586881 0.4 mg/kg|Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311346|NCT03177603|BG003|Baseline|GSK2586881 0.8 mg/kg|Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311347|NCT03177603|BG004|Baseline|Total|Total of all reporting groups
11311348|NCT03177603|FG000|Participant Flow|GSK2586881 0.1 mg/kg|Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311349|NCT03177603|FG001|Participant Flow|GSK2586881 0.2 mg/kg|Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311350|NCT03177603|FG002|Participant Flow|GSK2586881 0.4 mg/kg|Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311351|NCT03177603|FG003|Participant Flow|GSK2586881 0.8 mg/kg|Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311352|NCT03177603|OG000|Outcome|GSK2586881 0.1 mg/kg|Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311353|NCT03177603|OG001|Outcome|GSK2586881 0.2 mg/kg|Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311354|NCT03177603|OG002|Outcome|GSK2586881 0.4 mg/kg|Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311355|NCT03177603|OG003|Outcome|GSK2586881 0.8 mg/kg|Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311356|NCT03177603|EG000|Reported Event|GSK2586881 0.1 mg/kg|Participants received a single IV dose of 0.1 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311357|NCT03177603|EG001|Reported Event|GSK2586881 0.2 mg/kg|Participants received a single IV dose of 0.2 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311358|NCT03177603|EG002|Reported Event|GSK2586881 0.4 mg/kg|Participants received a single IV dose of 0.4 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311359|NCT03177603|EG003|Reported Event|GSK2586881 0.8 mg/kg|Participants received a single IV dose of 0.8 mg/kg GSK2586881 and were followed up till 28 days post-dose.
11311360|NCT03177798|BG000|Baseline|Icatibant Then Placebo|"Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)~Washout, then~Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311361|NCT03177798|BG001|Baseline|Placebo Then Icatibant|"Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Washout, then~Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311362|NCT03177798|BG002|Baseline|Total|Total of all reporting groups
11311363|NCT03177798|FG000|Participant Flow|Icatibant Then Placebo|"Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Washout, then~Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311364|NCT03177798|FG001|Participant Flow|Placebo Then Icatibant|"Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Washout, then~Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311365|NCT03177798|OG000|Outcome|Icatibant|"Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)~Icatibant: Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, The investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311366|NCT03177798|OG001|Outcome|Placebo|"Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)~Placebo: Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311367|NCT03177798|OG000|Outcome|Icatibant|Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours). Blood pressure was monitored before, during, and up to 1 hour after the end of the hemodialysis procedure.
11311368|NCT03177798|OG001|Outcome|Placebo|Placebo was intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours). Blood pressure was monitored before, during, and up to 1 hour after the end of the hemodialysis procedure.
11311369|NCT03177798|EG000|Reported Event|Icatibant|"Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311370|NCT03177798|EG001|Reported Event|Placebo|"Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).~Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy."
11311371|NCT03178266|BG000|Baseline|Zip Closure Device|"Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311372|NCT03178266|BG001|Baseline|Metal Staples|"Patients will receive Metal Staples for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311373|NCT03178266|BG002|Baseline|Total|Total of all reporting groups
11311374|NCT03178266|FG000|Participant Flow|Zip Closure Device|"Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311375|NCT03178266|FG001|Participant Flow|Metal Staples|"Patients will receive Metal Staples for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311376|NCT03178266|OG000|Outcome|Zip Closure Device|"Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311377|NCT03178266|OG001|Outcome|Metal Staples|"Patients will receive Metal Staples for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311378|NCT03178266|EG000|Reported Event|Zip Closure Device|"Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311379|NCT03178266|EG001|Reported Event|Metal Staples|"Patients will receive Metal Staples for final skin closure after knee arthroplasty.~Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned."
11311380|NCT03178344|BG000|Baseline|Overall Group (Both Sham and Alpha Stimulation)|Participants received sham stimulation at one session and alpha stimulation at the other in a randomized order. Sessions were separated by 5-9 days.
11311381|NCT03178344|FG000|Participant Flow|Sham Stimulation, Then Alpha Stimulation|"Participants will receive sham stimulation at the first session. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham. Then, participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11311382|NCT03178344|FG001|Participant Flow|Alpha Stimulation, Then Sham Stimulation|"Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Then, participants will receive sham stimulation at the second session. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11311383|NCT03178344|OG000|Outcome|Sham Stimulation|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11311384|NCT03178344|OG001|Outcome|Alpha Stimulation|"Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11311385|NCT03178344|EG000|Reported Event|Sham Stimulation|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11311386|NCT03178344|EG001|Reported Event|Alpha Stimulation|"Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11311387|NCT03178669|BG000|Baseline|Cobitolimod Dose 2x31 mg|"Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311388|NCT03178669|BG001|Baseline|Cobitolimod Dose 2x125 mg|"Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311389|NCT03178669|BG002|Baseline|Cobitolimod Dose 2x250 mg|"Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311390|NCT03178669|BG003|Baseline|Cobitolimod Dose 4x125 mg|"Dose 125 mg of cobitolimod, at 4 occasions~cobitolimod: Rectal administration"
11311391|NCT03178669|BG004|Baseline|Placebo|"Placebo at four occasions~Placebo: Solution manufactured to mimic cobitolimod"
11311392|NCT03178669|BG005|Baseline|Total|Total of all reporting groups
11311393|NCT03178669|FG000|Participant Flow|Cobitolimod Dose 2x31 mg|"Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311394|NCT03178669|FG001|Participant Flow|Cobitolimod Dose 2x125 mg|"Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311395|NCT03178669|FG002|Participant Flow|Cobitolimod Dose 2x250 mg|"Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311396|NCT03178669|FG003|Participant Flow|Cobitolimod Dose 4x125 mg|"Dose 125 mg of cobitolimod, at 4 occasions~cobitolimod: Rectal administration"
10822272|NCT00075725|FG001|Participant Flow|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11311397|NCT03178669|FG004|Participant Flow|Placebo|"Placebo at four occasions~Placebo: Solution manufactured to mimic cobitolimod"
11311398|NCT03178669|OG000|Outcome|Cobitolimod Dose 2x31 mg|"Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311399|NCT03178669|OG001|Outcome|Cobitolimod Dose 2x125 mg|"Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311400|NCT03178669|OG002|Outcome|Cobitolimod Dose 2x250 mg|"Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311401|NCT03178669|OG003|Outcome|Cobitolimod Dose 4x125 mg|"Dose 125 mg of cobitolimod, at 4 occasions~cobitolimod: Rectal administration"
11311402|NCT03178669|OG004|Outcome|Placebo|"Placebo at four occasions~Placebo: Solution manufactured to mimic cobitolimod"
11311403|NCT03178669|EG000|Reported Event|Cobitolimod Dose 2x31 mg|"Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311404|NCT03178669|EG001|Reported Event|Cobitolimod Dose 2x125 mg|"Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311405|NCT03178669|EG002|Reported Event|Cobitolimod Dose 2x250 mg|"Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions~cobitolimod: Rectal administration"
11311406|NCT03178669|EG003|Reported Event|Cobitolimod Dose 4x125 mg|"Dose 125 mg of cobitolimod, at 4 occasions~cobitolimod: Rectal administration"
11311407|NCT03178669|EG004|Reported Event|Placebo|"Placebo at four occasions~Placebo: Solution manufactured to mimic cobitolimod"
11311408|NCT03178773|BG000|Baseline|TExT-MED Only|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.~TExT-MED: messages designed to inspire motivation and behavior change"
11311409|NCT03178773|BG001|Baseline|TExT-MED+FANS|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.~TExT-MED: messages designed to inspire motivation and behavior change~FANS: SMS delivered messages to family members to improve social support"
11311410|NCT03178773|BG002|Baseline|Total|Total of all reporting groups
11311411|NCT03178773|FG000|Participant Flow|TExT-MED Only|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.~TExT-MED: messages designed to inspire motivation and behavior change"
11311412|NCT03178773|FG001|Participant Flow|TExT-MED+FANS|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.~TExT-MED: messages designed to inspire motivation and behavior change~FANS: SMS delivered messages to family members to improve social support"
11311413|NCT03178773|OG000|Outcome|TExT-MED Only|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.~TExT-MED: messages designed to inspire motivation and behavior change"
11311414|NCT03178773|OG001|Outcome|TExT-MED+FANS|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.~TExT-MED: messages designed to inspire motivation and behavior change~FANS: SMS delivered messages to family members to improve social support"
11311415|NCT03178773|OG002|Outcome|Total|Both arms combined
11311416|NCT03178773|EG000|Reported Event|TExT-MED Only|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.~TExT-MED: messages designed to inspire motivation and behavior change"
11311417|NCT03178773|EG001|Reported Event|TExT-MED+FANS|"Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.~TExT-MED: messages designed to inspire motivation and behavior change~FANS: SMS delivered messages to family members to improve social support"
11311418|NCT03178851|BG000|Baseline|Cohort A|Participants with disease progression on or after treatment with an anti-PD-1 agent initiated dosing with atezolizumab concurrently with cobimetinib. Participants received intravenous (IV) atezolizumab every two weeks (Q2W) on Days 1 and 15 of all cycles. Participants received oral cobimetinib once daily (QD) on Days 1-21 of each 28-day cycle.
11311419|NCT03178851|BG001|Baseline|Cohort B|Participants with disease progression on or after treatment with an anti-PD-1 agent received cobimetinib prior to initiating IV atezolizumab treatment on Day 15 of Cycle 1. Participants continued to receive atezolizumab on Days 1 and 15 from Cycle 2 onwards. Oral cobimetinib was given QD on Days 1-21 of each 28-day cycle. Participants in this cohort underwent tumor biopsies before and during treatment.
11311420|NCT03178851|BG002|Baseline|Cohort C|Participants with advanced melanoma, who had not received previous treatment, received IV atezolizumab monotherapy every 3 weeks (Q3W).
11311421|NCT03178851|BG003|Baseline|Total|Total of all reporting groups
11311422|NCT03178851|FG000|Participant Flow|Cohort A|Participants with disease progression on or after treatment with an anti-PD-1 agent initiated dosing with atezolizumab concurrently with cobimetinib. Participants received intravenous (IV) atezolizumab every two weeks (Q2W) on Days 1 and 15 of all cycles. Participants received oral cobimetinib once daily (QD) on Days 1-21 of each 28-day cycle.
11311423|NCT03178851|FG001|Participant Flow|Cohort B|Participants with disease progression on or after treatment with an anti-PD-1 agent received cobimetinib prior to initiating IV atezolizumab treatment on Day 15 of Cycle 1. Participants continued to receive atezolizumab on Days 1 and 15 from Cycle 2 onwards. Oral cobimetinib was given QD on Days 1-21 of each 28-day cycle. Participants in this cohort underwent tumor biopsies before and during treatment.
11311424|NCT03178851|FG002|Participant Flow|Cohort C|Participants with advanced melanoma, who had not received previous treatment, received IV atezolizumab monotherapy every 3 weeks (Q3W).
11311425|NCT03178851|OG000|Outcome|Cohort A|Participants with disease progression on or after treatment with an anti-PD-1 agent initiated dosing with atezolizumab concurrently with cobimetinib. Participants received intravenous (IV) atezolizumab every two weeks (Q2W) on Days 1 and 15 of all cycles. Participants received oral cobimetinib once daily (QD) on Days 1-21 of each 28-day cycle.
11311426|NCT03178851|OG001|Outcome|Cohort B|Participants with disease progression on or after treatment with an anti-PD-1 agent received cobimetinib prior to initiating IV atezolizumab treatment on Day 15 of Cycle 1. Participants continued to receive atezolizumab on Days 1 and 15 from Cycle 2 onwards. Oral cobimetinib was given QD on Days 1-21 of each 28-day cycle. Participants in this cohort underwent tumor biopsies before and during treatment.
11311427|NCT03178851|OG002|Outcome|Cohort C|Participants with advanced melanoma, who had not received previous treatment, received IV atezolizumab monotherapy every 3 weeks (Q3W).
11311428|NCT03178851|OG000|Outcome|Cohort C|Participants with advanced melanoma, who had not received previous treatment, received IV atezolizumab monotherapy every 3 weeks (Q3W).
11311429|NCT03178851|EG000|Reported Event|Cohort A|Participants with disease progression on or after treatment with an anti-PD-1 agent initiated dosing with atezolizumab concurrently with cobimetinib. Participants received intravenous (IV) atezolizumab every two weeks (Q2W) on Days 1 and 15 of all cycles. Participants received oral cobimetinib once daily (QD) on Days 1-21 of each 28-day cycle.
11311430|NCT03178851|EG001|Reported Event|Cohort B|Participants with disease progression on or after treatment with an anti-PD-1 agent received cobimetinib prior to initiating IV atezolizumab treatment on Day 15 of Cycle 1. Participants continued to receive atezolizumab on Days 1 and 15 from Cycle 2 onwards. Oral cobimetinib was given QD on Days 1-21 of each 28-day cycle. Participants in this cohort underwent tumor biopsies before and during treatment.
11311431|NCT03178851|EG002|Reported Event|Cohort C|Participants with advanced melanoma, who had not received previous treatment, received IV atezolizumab monotherapy every 3 weeks (Q3W).
11311432|NCT03178942|BG000|Baseline|Reference: Elimite™ Cream|"Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)~Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%"
10842474|NCT00246740|BG001|Baseline|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
11311433|NCT03178942|BG001|Baseline|Test: Permethrin Cream, 5%|"Test: Permethrin Cream, 5% (Encube Ethicals)~Permethrin Cream, 5%: Permethrin Cream 5%"
11311434|NCT03178942|BG002|Baseline|Total|Total of all reporting groups
11311435|NCT03178942|FG000|Participant Flow|Reference: Elimite™ Cream|"Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)~Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%"
11311436|NCT03178942|FG001|Participant Flow|Test: Permethrin Cream, 5%|"Test: Permethrin Cream, 5% (Encube Ethicals)~Permethrin Cream, 5%: Permethrin Cream 5%"
11311437|NCT03178942|OG000|Outcome|Reference: Elimite™ Cream|"Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)~Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%"
11311438|NCT03178942|OG001|Outcome|Test: Permethrin Cream, 5%|"Test: Permethrin Cream, 5% (Encube Ethicals)~Permethrin Cream, 5%: Permethrin Cream 5%"
11311439|NCT03178942|EG000|Reported Event|Reference: Elimite™ Cream|"Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)~Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%"
11311440|NCT03178942|EG001|Reported Event|Test: Permethrin Cream, 5%|"Test: Permethrin Cream, 5% (Encube Ethicals)~Permethrin Cream, 5%: Permethrin Cream 5%"
11311441|NCT03179319|BG000|Baseline|MyChoices|"Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.~Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing."
11311442|NCT03179319|BG001|Baseline|Standard of Care|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311443|NCT03179319|BG002|Baseline|Total|Total of all reporting groups
11311444|NCT03179319|FG000|Participant Flow|MyChoices|"Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.~Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing."
11311445|NCT03179319|FG001|Participant Flow|Standard of Care|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311446|NCT03179319|OG000|Outcome|MyChoices|"Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.~Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing."
11311447|NCT03179319|OG001|Outcome|Standard of Care|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11311448|NCT03179319|EG000|Reported Event|MyChoices|"Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.~Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing."
11311449|NCT03179319|EG001|Reported Event|Standard of Care|Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
11333194|NCT03510481|FG000|Participant Flow|Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11311450|NCT03179345|BG000|Baseline|Gral First, Then Neur, Lyr, and Plbo|"Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311451|NCT03179345|BG001|Baseline|Neur First, Then Plbo, Gral, and Lyr|"Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311452|NCT03179345|BG002|Baseline|Lyr First, Then Gral, Plbo, and Neur|"Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311453|NCT03179345|BG003|Baseline|Plbo First, Then Lyr, Neur, and Gral|"Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311454|NCT03179345|BG004|Baseline|Total|Total of all reporting groups
11311455|NCT03179345|FG000|Participant Flow|Gral First, Then Neur, Lyr, and Plbo|"Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311456|NCT03179345|FG001|Participant Flow|Neur First, Then Plbo, Gral, and Lyr|"Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311457|NCT03179345|FG002|Participant Flow|Lyr First, Then Gral, Plbo, and Neur|"Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311458|NCT03179345|FG003|Participant Flow|Plbo First, Then Lyr, Neur, and Gral|"Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.~Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.~Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.~Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.~All treatments were administered following a meal.~Each treatment period was separated by a 7-day washout interval."
11311459|NCT03179345|OG000|Outcome|Gralise® (Gabapentin)|Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
11311460|NCT03179345|OG001|Outcome|Neurontin® (Gabapentin)|Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
11311461|NCT03179345|OG002|Outcome|Placebo|Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
11311462|NCT03179345|OG001|Outcome|Lyrica® (Pregabalin)|Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
11311463|NCT03179345|OG000|Outcome|Gralise® (Gabapentin)|"Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule.~Gabapentin"
11311464|NCT03179345|OG001|Outcome|Neurontin® (Gabapentin)|"Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.~Gabapentin"
11311465|NCT03179345|OG002|Outcome|Lyrica® (Pregabalin)|"Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.~Pregabalin"
11311466|NCT03179345|OG003|Outcome|Placebo (Sugar Pill)|"Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.~Placebo"
11311467|NCT03179345|OG002|Outcome|Lyrica® (Pregabalin)|Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
11311468|NCT03179345|OG003|Outcome|Placebo (Sugar Pill)|Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.
11311469|NCT03179345|EG000|Reported Event|Gralise® (Gabapentin)|Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2.
11311470|NCT03179345|EG001|Reported Event|Neurontin® (Gabapentin)|Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3.
11311471|NCT03179345|EG002|Reported Event|Lyrica® (Pregabalin)|Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3.
11311472|NCT03179345|EG003|Reported Event|Placebo (Sugar Pill)|Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®.
11311473|NCT03179410|BG000|Baseline|Single Arm-arm Phase II Study of Avelumab|Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
11311474|NCT03179410|FG000|Participant Flow|Single Arm-arm Phase II Study of Avelumab|Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
11311475|NCT03179410|OG000|Outcome|Single Arm-arm Phase II Study of Avelumab|Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
11311476|NCT03179410|EG000|Reported Event|Single Arm-arm Phase II Study of Avelumab|Subjects with metastatic neuroendocrine-like prostate cancer will be treated with Avelumab intravenously at a dose of 10 mg/kg every 2 weeks.
11311477|NCT03179787|BG000|Baseline|Safety Analysis Group|Five hundred and twenty-eight patients were enrolled at 100 sites across Japan, and 526 case reports were collected during the period of April 2017 to September 2019. The safety analysis population consisted of 510 patients. Among excluded patients, 15 patients were lost to follow-up, and one patient was not treated with aripiprazole.
11311478|NCT03179787|FG000|Participant Flow|Safety Analysis Group|Five hundred and twenty-eight patients were enrolled at 100 sites across Japan, and 526 case reports were collected during the period of April 2017 to September 2019. The safety analysis population consisted of 510 patients. Among excluded patients, 15 patients were lost to follow-up, and one patient was not treated with aripiprazole.
11311479|NCT03179787|OG000|Outcome|Safety Analysis Group|Five hundred and twenty-eight patients were enrolled at 100 sites across Japan, and 526 case reports were collected during the period of April 2017 to September 2019. The safety analysis population consisted of 510 patients. Among excluded patients, 15 patients were lost to follow-up, and one patient was not treated with aripiprazole.
11311480|NCT03179787|EG000|Reported Event|Safety Analysis Group|Five hundred and twenty-eight patients were enrolled at 100 sites across Japan, and 526 case reports were collected during the period of April 2017 to September 2019. The safety analysis population consisted of 510 patients. Among excluded patients, 15 patients were lost to follow-up, and one patient was not treated with aripiprazole.
11311481|NCT03179891|BG000|Baseline|Adult Subjects With Epilepsy|Adult subjects with epilepsy admitted to an Epilepsy Monitoring Unit to receive a single 12.5 mg DBF dose during the Ictal Phase and during the Interictal/Peri-ictal Phase with at least 14 days between the 2 periods
11311482|NCT03179891|FG000|Participant Flow|Interictal State First, Then Ictal/Peri-ictal State|Subjects received DBF 12.5 mg during the Interical State first and then during the Ictal/Peri-ictal State with at least 14 days washout between the 2 periods.
11311483|NCT03179891|FG001|Participant Flow|Ictal/Peri-Ictal State First, Then Interictal State|Subjects received DBF 12.5 mg during the ictal/peri-ictal state first and then during the interictal state with at least 14 days washout between the 2 periods.
11311484|NCT03179891|OG000|Outcome|Interictal State|"Single 12.5-mg dose of Diazepam Buccal Film administered during the interictal state~Adult subjects with epilepsy"
11311485|NCT03179891|OG001|Outcome|Ictal/Peri-ictal State|"Single 12.5-mg dose of Diazepam Buccal Film administered during the ictal/peri-ictal state~Adult subjects with epilepsy"
11311486|NCT03179891|OG000|Outcome|Interictal State|"Single 12.5 mg dose of Diazepam Buccal Film administered during the interictal state~Adult subjects with epilepsy"
11311487|NCT03179891|OG001|Outcome|Ictal/Peri-ictal State|"Single 12.5 mg dose of Diazepam Buccal Film administered during the ictal/peri-ictal state.~Adult subjects with epilepsy"
11311488|NCT03179891|OG000|Outcome|Interictal State|"Single 12.5-mg dose of Diazepam Buccal Film administered during the interictal state.~Adult subjects with epilepsy"
11311489|NCT03179891|EG000|Reported Event|Interictal State (Period A)|"Single 12.5-mg dose of Diazepam Buccal Film administered during the interictal state.~Adult subjects with epilepsy"
11311490|NCT03179891|EG001|Reported Event|Ictal/Peri-ictal State (Period B)|"Single 12.5-mg dose of Diazepam Buccal Film administered during the ictal/peri-ictal state.~Adult subjects with epilepsy"
11311491|NCT03180138|BG000|Baseline|Controls|A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
11311492|NCT03180138|BG001|Baseline|Reminders Alone|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311493|NCT03180138|BG002|Baseline|Reminders + Compliance-linked Incentives|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311494|NCT03180138|BG003|Baseline|Total|Total of all reporting groups
11311495|NCT03180138|FG000|Participant Flow|Controls|A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
11311496|NCT03180138|FG001|Participant Flow|Reminders Alone|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311497|NCT03180138|FG002|Participant Flow|Reminders + Compliance-linked Incentives|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311498|NCT03180138|OG000|Outcome|Controls|A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
11311499|NCT03180138|OG001|Outcome|Reminders Alone|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311500|NCT03180138|OG002|Outcome|Reminders + Compliance-linked Incentives|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311501|NCT03180138|EG000|Reported Event|Controls|A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
10822273|NCT00075725|FG002|Participant Flow|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10842475|NCT00246740|BG002|Baseline|Total|Total of all reporting groups
11311502|NCT03180138|EG001|Reported Event|Reminders Alone|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311503|NCT03180138|EG002|Reported Event|Reminders + Compliance-linked Incentives|"Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).~Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).~A cloud-based, biometric-linked software platform was used for positive identification, and record keeping."
11311504|NCT03180385|BG000|Baseline|Neurally-Adjusted Ventilatory Assist (NAVA)|"Synchronized biphasic non-invasive respiratory support~Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient."
11311505|NCT03180385|BG001|Baseline|Biphasic Positive Airway Pressure Support (BiPAP)|"Conventional non-invasive respiratory support~Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion."
11311506|NCT03180385|BG002|Baseline|Total|Total of all reporting groups
11311507|NCT03180385|FG000|Participant Flow|Neurally-Adjusted Ventilatory Assist (NAVA)|"Synchronized biphasic non-invasive respiratory support~Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient."
11311508|NCT03180385|FG001|Participant Flow|Biphasic Positive Airway Pressure Support (BiPAP)|"Conventional non-invasive respiratory support~Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion."
11311509|NCT03180385|OG000|Outcome|Neurally-Adjusted Ventilatory Assist (NAVA)|"Synchronized biphasic non-invasive respiratory support~Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient."
11311510|NCT03180385|OG001|Outcome|Biphasic Positive Airway Pressure Support (BiPAP)|"Conventional non-invasive respiratory support~Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion."
11311511|NCT03180385|EG000|Reported Event|Neurally-Adjusted Ventilatory Assist (NAVA)|"Synchronized biphasic non-invasive respiratory support~Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient."
11311512|NCT03180385|EG001|Reported Event|Biphasic Positive Airway Pressure Support (BiPAP)|"Conventional non-invasive respiratory support~Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion."
11311513|NCT03180489|BG000|Baseline|Dapagliflozin With Dietary Counseling|"Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.~Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311514|NCT03180489|BG001|Baseline|Placebo With Dietary Counseling|"Daily oral administration of placebo tablet with dietary counseling to promote weight loss.~Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311515|NCT03180489|BG002|Baseline|Total|Total of all reporting groups
11311516|NCT03180489|FG000|Participant Flow|Dapagliflozin With Dietary Counseling|"Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.~Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311517|NCT03180489|FG001|Participant Flow|Placebo With Dietary Counseling|"Daily oral administration of placebo tablet with dietary counseling to promote weight loss.~Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311518|NCT03180489|OG000|Outcome|Dapagliflozin With Dietary Counseling|"Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.~Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311519|NCT03180489|OG001|Outcome|Placebo With Dietary Counseling|"Daily oral administration of placebo tablet with dietary counseling to promote weight loss.~Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311520|NCT03180489|EG000|Reported Event|Dapagliflozin With Dietary Counseling|"Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.~Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311521|NCT03180489|EG001|Reported Event|Placebo With Dietary Counseling|"Daily oral administration of placebo tablet with dietary counseling to promote weight loss.~Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study."
11311522|NCT03180515|BG000|Baseline|Activa PC+S Neurostimulator|All patients
11311523|NCT03180515|FG000|Participant Flow|Activa PC+S Neurostimulator|"For Aim 1, all participants participated in the same state - off dopaminergic medication and off deep brain stimulation (DBS), so that we could characterize the two groups (freezers and non-freezers, respectively people who experience freezing of gait and those who do not) at baseline.~For Aim 2, all participants underwent randomized presentations of OFF, 60 Hz DBS and 140 Hz DBS while completing several walking tasks. (So all participants had walking trials off stimulatoin, all had walking trials at 60 Hz DBS, all had walking trials at 140 Hz DBS).~For Aim 3, due to technological limitations and resources, only one subject completed the stepping in place task while on continuous DBS (cDBS), and completed the stepping in place task again while on adaptive DBS (aDBS).~For Aim 3, Aim 1 Arms: Freezers vs. non-freezers Aim 2 Arms: OFF vs. 60 Hz DBS vs. 140 Hz DBS Aim 3 Arms: OFF vs. cDBS vs. aDBS"
11311524|NCT03180515|OG000|Outcome|(OFF) Activa PC+S Neurostimulator|OFF stimulation
11311525|NCT03180515|OG001|Outcome|(cDBS) Activa PC+S Neurostimulator|Continuous or open-loop DBS
11311526|NCT03180515|OG002|Outcome|(aDBS) Activa PC+S Neurostimulator|Adaptive DBS
11311527|NCT03180515|OG000|Outcome|Freezers|PD subjects with Freezing of Gait
11311528|NCT03180515|OG001|Outcome|Non-Freezers|PD subjects without Freezing of Gait
11311529|NCT03180515|OG000|Outcome|Freezers (OFF Stim)|PD subjects with Freezing of Gait OFF Stimulation
11311530|NCT03180515|OG001|Outcome|Freezers (60 Hz Stim)|PD subjects with Freezing of Gait on 60 Hz Stimulation
11311531|NCT03180515|OG002|Outcome|Freezers (140 Hz Stim)|PD subjects with Freezing of Gait on 140 Hz Stimulation
11311532|NCT03180515|OG003|Outcome|Non-Freezers (OFF Stim)|PD subjects without Freezing of Gait OFF Stimulation
11311533|NCT03180515|OG004|Outcome|Non-Freezers (60 Hz Stim)|PD subjects without Freezing of Gait on 60 Hz Stimulation
11311534|NCT03180515|OG005|Outcome|Non-Freezers (140 Hz Stim)|PD subjects without Freezing of Gait on 140 Hz Stimulation
11311535|NCT03180515|EG000|Reported Event|Activa PC+S Neurostimulator Aim 1|Aim 1 Arms: Freezers vs. non-freezers All participants participated in Aim 1
11311536|NCT03180515|EG001|Reported Event|Activa PC +S Neurostimulator Aim 2|"Aim 2 Arms: OFF vs. 60 Hz DBS vs. 140 Hz DBS~All participants participated in Aim 2.~Within participant, adverse effects were assessed between OFF DBS, 60 Hz DBS and 140 Hz DBS."
11311537|NCT03180515|EG002|Reported Event|Activa PC +S Neurostimulator Aim 3|"Aim 3 Arms: OFF vs. cDBS vs. aDBS~Due to limitations in technology and resources, only one participant participated in Aim 3.~Within participant, adverse effects were assessed between OFF DBS, cDBS, and aDBS."
11311538|NCT03180528|BG000|Baseline|Treatment (Remetinostat)|"Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.~Remetinostat: Applied topically under bandage occlusion"
11311539|NCT03180528|FG000|Participant Flow|Treatment (Remetinostat)|"Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.~Remetinostat: Applied topically under bandage occlusion"
11311540|NCT03180528|OG000|Outcome|Treatment (Remetinostat)|"Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.~Remetinostat: Applied topically under bandage occlusion"
11311541|NCT03180528|EG000|Reported Event|Treatment (Remetinostat)|"Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.~Remetinostat: Applied topically under bandage occlusion"
11311542|NCT03180619|BG000|Baseline|Part A (Renal Impairment): Moderate or Severe Renal Impairment|Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311543|NCT03180619|BG001|Baseline|Part A (Renal Impairment): End Stage Renal Disease|Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311544|NCT03180619|BG002|Baseline|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311545|NCT03180619|BG003|Baseline|Total|Total of all reporting groups
11311546|NCT03180619|FG000|Participant Flow|Part A (Renal Impairment): Moderate or Severe Renal Impairment|Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
11311547|NCT03180619|FG001|Participant Flow|Part A (Renal Impairment): End Stage Renal Disease|Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311548|NCT03180619|FG002|Participant Flow|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311549|NCT03180619|OG000|Outcome|Part A (Renal Impairment): Moderate or Severe Renal Impairment|Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311550|NCT03180619|OG001|Outcome|Part A (Renal Impairment): End Stage Renal Disease|Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311551|NCT03180619|OG002|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311552|NCT03180619|OG000|Outcome|Part A (Renal Impairment): Moderate or Severe Renal Impairment|Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
11311553|NCT03180619|OG001|Outcome|Part A (Renal Impairment): End Stage Renal Disease|Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311554|NCT03180619|OG002|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311555|NCT03180619|OG001|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311556|NCT03180619|OG001|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311557|NCT03180619|OG000|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311558|NCT03180619|OG000|Outcome|Part B: Hepatic Impairment|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311559|NCT03180619|EG000|Reported Event|Part A (Renal Impairment): Moderate or Severe Renal Impairment|Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311560|NCT03180619|EG001|Reported Event|Part A (Renal Impairment): End Stage Renal Disease (Cohort 2)|Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11311561|NCT03180619|EG002|Reported Event|Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair|Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
11333195|NCT03510481|FG001|Participant Flow|Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333196|NCT03510481|FG002|Participant Flow|Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks|Control for Arm 1. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333197|NCT03510481|FG003|Participant Flow|Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks|Control for Arm 2. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333198|NCT03510481|OG000|Outcome|Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x 10^5) via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333199|NCT03510481|OG001|Outcome|Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x 10^5) via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333200|NCT03510481|OG002|Outcome|Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks|Control for Arm 1. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333201|NCT03510481|OG003|Outcome|Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks|Control for Arm 2. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333202|NCT03510481|OG000|Outcome|Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333203|NCT03510481|OG001|Outcome|Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333204|NCT03510481|EG000|Reported Event|Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333205|NCT03510481|EG001|Reported Event|Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks|Participants received 3 doses of PfSPZ Vaccine (9 x10^5) via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd vaccination. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11311562|NCT05091047|BG000|Baseline|Erchonia EVRL|"635 nanometers (nm) and 405 nm laser application~Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks."
11311563|NCT05091047|FG000|Participant Flow|Erchonia EVRL|"635 nanometers (nm) and 405 nm laser application~Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks."
11311564|NCT05091047|OG000|Outcome|Erchonia EVRL|"635 nanometers (nm) and 405 nm laser application~Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks."
11311565|NCT05091047|EG000|Reported Event|Erchonia EVRL|"635 nanometers (nm) and 405 nm laser application~Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks."
11311586|NCT04450108|BG000|Baseline|Test Cohort|"Subjects age 7 to 80 with asthma~Vivatmo pro FeNO Test: Breath gas analysis"
11311587|NCT04450108|FG000|Participant Flow|Test Cohort|"Subjects age 7 to 80 with asthma~Vivatmo pro FeNO Test: Breath gas analysis"
11311588|NCT04450108|OG000|Outcome|Test Cohort|"Subjects age 7 to 80 with asthma~Vivatmo pro FeNO Test: Breath gas analysis"
11311589|NCT04450108|EG000|Reported Event|Test Cohort|"Subjects age 7 to 80 with asthma~Vivatmo pro FeNO Test: Breath gas analysis"
11311590|NCT04448756|BG000|Baseline|Placebo|Participants received matched placebo tablets to M5049 daily for 14 days.
11311591|NCT04448756|BG001|Baseline|M5049 50 Milligram (mg)|Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
11311592|NCT04448756|BG002|Baseline|M5049 100 mg|Participants received M5049 100 mg orally twice daily for 14 days.
11311593|NCT04448756|BG003|Baseline|Total|Total of all reporting groups
11311594|NCT04448756|FG000|Participant Flow|Placebo|Participants received matched placebo tablets to M5049 daily for 14 days.
11311595|NCT04448756|FG001|Participant Flow|M5049 50 Milligram (mg)|Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
11311596|NCT04448756|FG002|Participant Flow|M5049 100 mg|Participants received M5049 100 mg orally twice daily for 14 days.
11311597|NCT04448756|OG000|Outcome|Placebo|Participants received matched placebo tablets to M5049 daily for 14 days.
11311598|NCT04448756|OG001|Outcome|M5049 50 Milligram (mg)|Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
11311599|NCT04448756|OG002|Outcome|M5049 100 mg|Participants received M5049 100 mg orally twice daily for 14 days.
11311600|NCT04448756|EG000|Reported Event|Placebo|Participants received matched placebo tablets to M5049 daily for 14 days.
11311601|NCT04448756|EG001|Reported Event|M5049 50 Milligram (mg)|Participants received M5049 50 milligram (mg) orally twice daily for 14 days.
11311602|NCT04448756|EG002|Reported Event|M5049 100 mg|Participants received M5049 100 mg orally twice daily for 14 days.
11311603|NCT04397718|BG000|Baseline|Placebo + BSC|"No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.~Saline: 09% Saline"
11311604|NCT04397718|BG001|Baseline|Degarelix + BSC|"Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.~Degarelix: Degarelix is an FDA-approved drug for prostate cancer"
11311605|NCT04397718|BG002|Baseline|Total|Total of all reporting groups
11311606|NCT04397718|FG000|Participant Flow|Placebo + BSC|"No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.~Saline: 09% Saline"
11311607|NCT04397718|FG001|Participant Flow|Degarelix + BSC|"Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.~Degarelix: Degarelix is an FDA-approved drug for prostate cancer"
11311608|NCT04397718|OG000|Outcome|Placebo + BSC|"No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.~Saline: 09% Saline"
11311609|NCT04397718|OG001|Outcome|Degarelix + BSC|"Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.~Degarelix: Degarelix is an FDA-approved drug for prostate cancer"
11311610|NCT04397718|EG000|Reported Event|Placebo + BSC|"No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.~Saline: 09% Saline"
11311611|NCT04397718|EG001|Reported Event|Degarelix + BSC|"Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.~Degarelix: Degarelix is an FDA-approved drug for prostate cancer"
11311566|NCT04957498|BG000|Baseline|FBT-V|"Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.~Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions."
11311567|NCT04957498|BG001|Baseline|GSH-FBT|"Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.~Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist."
11311568|NCT04957498|BG002|Baseline|Total|Total of all reporting groups
11311569|NCT04957498|FG000|Participant Flow|FBT-V|"Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.~Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions."
11311570|NCT04957498|FG001|Participant Flow|GSH-FBT|"Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.~Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist."
11311571|NCT04957498|OG000|Outcome|Overall Sample|Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
11311572|NCT04957498|OG000|Outcome|Overall Sample|Participants enrolled and randomized to a treatment arm.
11311573|NCT04957498|OG000|Outcome|FBT-V|"Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.~Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions."
11311574|NCT04957498|OG001|Outcome|GSH-FBT|"Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.~Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist."
11311575|NCT04957498|EG000|Reported Event|FBT-V|"Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.~Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions."
11311576|NCT04957498|EG001|Reported Event|GSH-FBT|"Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.~Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist."
11311612|NCT04352127|BG000|Baseline|Dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311613|NCT04352127|BG001|Baseline|Non-dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311614|NCT04352127|BG002|Baseline|Anesthesia Providers|Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
11311615|NCT04352127|BG003|Baseline|Total|Total of all reporting groups
11311616|NCT04352127|FG000|Participant Flow|Dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311617|NCT04352127|FG001|Participant Flow|Non-dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311618|NCT04352127|FG002|Participant Flow|Anesthesia Providers|Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
11311619|NCT04352127|OG000|Outcome|Anesthesia Providers|Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
11311620|NCT04352127|OG000|Outcome|Dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311621|NCT04352127|OG001|Outcome|Non-dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311622|NCT04352127|EG000|Reported Event|Dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311623|NCT04352127|EG001|Reported Event|Non-dominant Hand|"Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand~TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes."
11311624|NCT04352127|EG002|Reported Event|Anesthesia Providers|Anesthesiology residents and certified registered nurse anesthetists (CRNAs) that were responsible for the anesthesia administration during eligible subjects elective surgical procedures requiring neuromuscular blockage
11311625|NCT04253756|BG000|Baseline|All Study Participants|This includes participants where one half was assigned to 18G catheter SOC (control) and the other half be assigned to 20G BD Nexiva Diffusics catheter (intervention). Each participant may participate a maximum of 10 times.
11311626|NCT04253756|FG000|Participant Flow|All Study Participants|This includes participants where one half was assigned to 18G catheter SOC (control) and the other half be assigned to 20G BD Nexiva Diffusics catheter (intervention). Each participant may participate a maximum of 10 times.
11311627|NCT04253756|OG000|Outcome|18G Catheter SOC (Control)|The standard of care is an 18-gauge autogard catheter (control group)
11311628|NCT04253756|OG001|Outcome|20-gauge BD Nexiva Diffusics (Intervention)|20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
11311629|NCT04253756|EG000|Reported Event|18-gauge Autogard Catheter|Standard of care
11311630|NCT04253756|EG001|Reported Event|20-gauge BD Nexiva Diffusics|"Intervention~20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made."
11333206|NCT03510481|EG002|Reported Event|Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks|Control for Arm 1. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 8, 16 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333207|NCT03510481|EG003|Reported Event|Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks|Control for Arm 2. Participants received 3 doses of placebo saline injection via direct venous inoculation (DVI) at 0, 1, 4 weeks and a 4th dose at 38 weeks post 3rd injection. Oral antimalarial treatment with artemether 20mg/lumefantrine 120mg (AL) given orally with food with 4 tablets taken as a single initial dose, then 4 tabs again after 8hrs, then 4 tabs twice daily for the following two days for a total of 24 tabs, 2 weeks prior to 3rd and 4th injection.
11333208|NCT03510663|BG000|Baseline|Sequence 1 (ABDC)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of investigational medicinal product (IMP) administration in a treatment period and the next treatment period."
11333209|NCT03510663|BG001|Baseline|Sequence 2 (DACB)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333210|NCT03510663|BG002|Baseline|Sequence 3 (BCAD)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333211|NCT03510663|BG003|Baseline|Sequence 4 (CDBA)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333212|NCT03510663|BG004|Baseline|Sequence 5 (ABCD)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11311631|NCT04157751|BG000|Baseline|Placebo|1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.
11311632|NCT04157751|BG001|Baseline|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.
11311633|NCT04157751|BG002|Baseline|Total|Total of all reporting groups
11311634|NCT04157751|FG000|Participant Flow|Placebo|1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.
11311635|NCT04157751|FG001|Participant Flow|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.
11311636|NCT04157751|OG000|Outcome|Overall Group|"Overall group contains both empagliflozin and placebo group. Empagliflozin group: 1 film-coated tablet of 10 milligram (mg) empagliflozin was administered orally once daily in patients with acute heart failure.~Placebo group: 1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure."
11311637|NCT04157751|OG000|Outcome|Placebo|1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.
11311638|NCT04157751|OG001|Outcome|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.
11311639|NCT04157751|EG000|Reported Event|Placebo|1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.
11311640|NCT04157751|EG001|Reported Event|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.
11311641|NCT03975920|BG000|Baseline|Usual Care (UC)|The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
11311642|NCT03975920|BG001|Baseline|Experimental Care (EC)|"The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.~The Restful Jaw Device: The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures."
11311643|NCT03975920|BG002|Baseline|Total|Total of all reporting groups
11311644|NCT03975920|FG000|Participant Flow|Usual Care (UC)|The study control is Usual Care (UC), which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
11311645|NCT03975920|FG001|Participant Flow|Experimental Care (EC)|"The study intervention for Experimental Care (EC) is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.~The Restful Jaw Device: The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures."
11311646|NCT03975920|OG000|Outcome|Usual Care (UC)|The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
11311647|NCT03975920|OG001|Outcome|Experimental Care (EC)|"The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.~The Restful Jaw Device: The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures."
11311648|NCT03975920|EG000|Reported Event|Usual Care (UC)|The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
11311649|NCT03975920|EG001|Reported Event|Experimental Care (EC)|"The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.~The Restful Jaw Device: The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures."
11311650|NCT03917472|BG000|Baseline|Brolucizumab 6mg q4w|Brolucizumab 6 mg/0.05 mL every 4 weeks.
11311651|NCT03917472|BG001|Baseline|Aflibercept 2mg q4w|Aflibercept 2mg/0.05 mL every 4 weeks
11311652|NCT03917472|BG002|Baseline|Total|Total of all reporting groups
11311653|NCT03917472|FG000|Participant Flow|Brolucizumab 6mg q4w|Brolucizumab 6 mg/0.05 mL every 4 weeks.
11311654|NCT03917472|FG001|Participant Flow|Aflibercept 2mg q4w|Aflibercept 2mg/0.05 mL every 4 weeks
11311655|NCT03917472|OG000|Outcome|Brolucizumab 6mg q4w|Brolucizumab 6 mg/0.05 mL every 4 weeks.
11311656|NCT03917472|OG001|Outcome|Aflibercept 2mg q4w|Aflibercept 2mg/0.05 mL every 4 weeks
11311657|NCT03917472|EG000|Reported Event|Brolucizumab 6mg|Brolucizumab 6mg
11311658|NCT03917472|EG001|Reported Event|Aflibercept 2mg|Aflibercept 2mg
11311659|NCT03917472|EG002|Reported Event|Overall|Overall
11311669|NCT03746483|BG000|Baseline|MS1819 - PERT Sequence|Participants were first randomized to receive MS1819 first and PERT during the crossover phase
11311670|NCT03746483|BG001|Baseline|PERT - MS1819 Sequence|Participants were first randomized to receive PERT first and MS1819 during the crossover phase
11311671|NCT03746483|BG002|Baseline|Total|Total of all reporting groups
11311672|NCT03746483|FG000|Participant Flow|MS1819 2240 mg/Day (3 Weeks) Then PERT Pre-study Dose (3 Weeks)|Participants were first randomized to receive MS1819 first and PERT during the crossover phase
11311673|NCT03746483|FG001|Participant Flow|PERT Pre-study Dose (3 Weeks) Then MS1819 2240 mg/Day (3 Weeks)|Participants were first randomized to receive PERT first and MS1819 during the crossover phase
11311674|NCT03746483|OG000|Outcome|MS1819|Measured while participants on MS1819
11311675|NCT03746483|OG001|Outcome|PERT|Measured while participants on PERT
11311676|NCT03746483|OG000|Outcome|MS1819|AE reported during treatment with MS1819
11311677|NCT03746483|OG001|Outcome|PERT|AE reported during treatment with PERT
11311678|NCT03746483|EG000|Reported Event|MS1819|AE reported during treatment with MS1819
11311679|NCT03746483|EG001|Reported Event|PERT|AE reported during treatment with PERT
11311680|NCT03717155|BG000|Baseline|Avelumab and Cetuximab|Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
11311681|NCT03717155|FG000|Participant Flow|Avelumab and Cetuximab|Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
11311682|NCT03717155|OG000|Outcome|Avelumab and Cetuximab|Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
11333213|NCT03510663|BG005|Baseline|Sequence 6 (CADB)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333214|NCT03510663|BG006|Baseline|Sequence 7 (BDAC)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11311683|NCT03717155|EG000|Reported Event|Avelumab and Cetuximab|Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
11311684|NCT03694327|BG000|Baseline|Treatment A Mobile Application (CT-101-M)|"Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.~CT-101-M (Mobile Application): A reduced-functionality minimal viable product (MVP) version of Clickotine (CT-101)."
11311685|NCT03694327|BG001|Baseline|Treatment B Mobile Application (QuitGuide)|"Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.~QuitGuide: Mobile Application"
11311686|NCT03694327|BG002|Baseline|Total|Total of all reporting groups
11311687|NCT03694327|FG000|Participant Flow|Treatment A Mobile Application|"Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.~CT-101-M (Mobile Application): A reduced-functionality minimal viable product (MVP) version of Clickotine (CT-101)."
11311688|NCT03694327|FG001|Participant Flow|Treatment B Mobile Application|"Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.~QuitGuide: Mobile Application"
11311689|NCT03694327|OG000|Outcome|Treatment A Mobile Application (CT-101-M)|"Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.~CT-101-M (Mobile Application): A reduced-functionality minimal viable product (MVP) version of Clickotine (CT-101)."
11311690|NCT03694327|OG001|Outcome|Treatment B Mobile Application (QuitGuide)|"Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.~QuitGuide: Mobile Application"
11311691|NCT03694327|EG000|Reported Event|Treatment A Mobile Application (CT-101-M)|"Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.~CT-101-M (Mobile Application): A reduced-functionality minimal viable product (MVP) version of Clickotine (CT-101)."
11311692|NCT03694327|EG001|Reported Event|Treatment B Mobile Application (QuitGuide)|"Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.~QuitGuide: Mobile Application"
11311693|NCT03624036|BG000|Baseline|First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311694|NCT03624036|BG001|Baseline|First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311695|NCT03624036|BG002|Baseline|Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC < 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311696|NCT03624036|BG003|Baseline|Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
10848546|NCT00290342|EG001|Reported Event|Infanrix + IMOVAX Polio Group|Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
11311697|NCT03624036|BG004|Baseline|Total|Total of all reporting groups
11311698|NCT03624036|FG000|Participant Flow|First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered intravenously (IV) on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV on Day 0.
11311699|NCT03624036|FG001|Participant Flow|First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311700|NCT03624036|FG002|Participant Flow|Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL and small lymphocytic lymphoma (SLL) with ≤1% malignant cells in peripheral blood or absolute lymphocyte count (ALC) < 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311701|NCT03624036|FG003|Participant Flow|Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, B-cell lymphoma 2 (BCL-2) and Phosphoinositide 3-kinase (PI3k) inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311702|NCT03624036|OG000|Outcome|First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311703|NCT03624036|OG001|Outcome|First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311704|NCT03624036|OG002|Outcome|Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC < 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311705|NCT03624036|OG003|Outcome|Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311706|NCT03624036|EG000|Reported Event|First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311707|NCT03624036|EG001|Reported Event|First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311708|NCT03624036|EG002|Reported Event|Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC < 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11311709|NCT03624036|EG003|Reported Event|Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg|Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
11333215|NCT03510663|BG007|Baseline|Sequence 8 (DCBA)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333216|NCT03510663|BG008|Baseline|Total|Total of all reporting groups
11333217|NCT03510663|FG000|Participant Flow|Sequence 1 (ABDC)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of investigational medicinal product (IMP) administration in a treatment period and the next treatment period."
11333218|NCT03510663|FG001|Participant Flow|Sequence 2 (DACB)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333219|NCT03510663|FG002|Participant Flow|Sequence 3 (BCAD)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333220|NCT03510663|FG003|Participant Flow|Sequence 4 (CDBA)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11311719|NCT03137160|BG000|Baseline|Ixekizumab (Taltz)|"We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.~Ixekizumab: Injection"
11311720|NCT03137160|FG000|Participant Flow|Ixekizumab (Taltz)|"We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.~Ixekizumab: Injection"
11311721|NCT03137160|OG000|Outcome|Ixekizumab (Taltz)|"We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.~Ixekizumab: Injection"
11311722|NCT03137160|EG000|Reported Event|Ixekizumab (Taltz)|"We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.~Ixekizumab: Injection"
11311723|NCT03057951|BG000|Baseline|Placebo|1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311724|NCT03057951|BG001|Baseline|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311725|NCT03057951|BG002|Baseline|Total|Total of all reporting groups
11311726|NCT03057951|FG000|Participant Flow|Placebo|1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311727|NCT03057951|FG001|Participant Flow|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311728|NCT03057951|OG000|Outcome|Placebo|1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311729|NCT03057951|OG001|Outcome|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311730|NCT03057951|EG000|Reported Event|Placebo|1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311731|NCT03057951|EG001|Reported Event|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
11311732|NCT03007888|BG000|Baseline|All Study Participants|"The recommended first morning dose of IPX203 on Day 1 was based on the subject's prestudy IR CD-LD morning dose~The initial IR CD-LD dosing regimen was the same as the subject's stable prestudy regimen (unless s/he was taking a single daily bedtime dose of CR CD-LD, either alone or in combination with IR CD-LD, in which case, the CR CD-LD dose was discontinued and substituted with a 1:1 milligram-equivalent IR CD-LD dose)."
11311733|NCT03007888|FG000|Participant Flow|IPX203 First Then Sinemet|Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablets for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
11311734|NCT03007888|FG001|Participant Flow|Sinemet First Then IPX203|Participants first received Sinemet for 15 days After a Washout Period of 7 days; participants then received IPX203 for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
11311735|NCT03007888|OG000|Outcome|IPX203|Participants who received IPX203 ER Capsules on Day 1 of the study
11311736|NCT03007888|OG001|Outcome|Sinemet|Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
11311737|NCT03007888|OG000|Outcome|IPX203|Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study
11311738|NCT03007888|OG001|Outcome|Sinemet|Participants who received Sinemet (IR CD-LD) on Day 15 of the study
11311739|NCT03007888|EG000|Reported Event|IPX203|Participants received IPX203 ER CD-LD Capsules
11311740|NCT03007888|EG001|Reported Event|Sinemet|Participant received Sinemet (IR CD-LD) Tablets
11311741|NCT03007888|EG002|Reported Event|Washout Period|Washout between Period 1 and Period 2
11311742|NCT02971033|BG000|Baseline|Placebo|"placebo~Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks"
11311743|NCT02971033|BG001|Baseline|20mg/Day Ezetimibe|"20mg/day ezetimibe~20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks."
11311744|NCT02971033|BG002|Baseline|40mg/Day Ezetimibe|"40mg/day ezetimibe~40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks."
11311745|NCT02971033|BG003|Baseline|Total|Total of all reporting groups
11311746|NCT02971033|FG000|Participant Flow|Placebo|"placebo~Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks"
11311747|NCT02971033|FG001|Participant Flow|20mg/Day Ezetimibe|"20mg/day ezetimibe~20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks."
11311748|NCT02971033|FG002|Participant Flow|40mg/Day Ezetimibe|"40mg/day ezetimibe~40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks."
11311749|NCT02971033|OG000|Outcome|Placebo|"placebo~Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks"
11311750|NCT02971033|OG001|Outcome|20mg/Day Ezetimibe|"20mg/day ezetimibe~20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks."
11311751|NCT02971033|OG002|Outcome|40mg/Day Ezetimibe|"40mg/day ezetimibe~40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks."
11311752|NCT02971033|EG000|Reported Event|Placebo|"placebo~Placebo: Participants assigned to this intervention will receive placebo every day for 8 weeks"
11311753|NCT02971033|EG001|Reported Event|20mg/Day Ezetimibe|"20mg/day ezetimibe~20mg ezetimibe: Participants assigned to this intervention will receive 20mg per day of ezetimibe for 8 weeks."
11311754|NCT02971033|EG002|Reported Event|40mg/Day Ezetimibe|"40mg/day ezetimibe~40mg ezetimibe: Participants assigned to this intervention will receive 40mg per day of ezetimibe for 8 weeks."
11311755|NCT02961374|BG000|Baseline|Treatment (Erlotinib Hydrochloride)|Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
11311756|NCT02961374|FG000|Participant Flow|Treatment (Erlotinib Hydrochloride)|Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
11311757|NCT02961374|OG000|Outcome|Treatment (Erlotinib Hydrochloride)|Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
11311758|NCT02961374|EG000|Reported Event|Treatment (Erlotinib Hydrochloride)|Patients receive 350 mg erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
11311759|NCT02949934|BG000|Baseline|Placebo/rs4680 Val/Val|"Placebo three times per day for eight days~Individuals with the rs4680 val/val genotype"
11311760|NCT02949934|BG001|Baseline|Tolcapone/rs4680 Val/Val|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/val genotype"
11311761|NCT02949934|BG002|Baseline|Placebo/rs4680 Val/Met|"Placebo three times per day for eight days~Individuals with the rs4680 val/met genotype"
11311762|NCT02949934|BG003|Baseline|Tolcapone/rs4680 Val/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/met genotype"
11311763|NCT02949934|BG004|Baseline|Placebo/rs4680 Met/Met|"Placebo three times per day for eight days~Individuals with the rs4680 met/met genotype"
11311764|NCT02949934|BG005|Baseline|Tolcapone/rs4680 Met/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 met/met genotype"
11311765|NCT02949934|BG006|Baseline|Total|Total of all reporting groups
11311766|NCT02949934|FG000|Participant Flow|Placebo/rs4680 Val/Val|"Placebo three times per day for eight days~Individuals with the rs4680 val/val genotype"
11311767|NCT02949934|FG001|Participant Flow|Tolcapone/rs4680 Val/Val|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/val genotype"
11311768|NCT02949934|FG002|Participant Flow|Placebo/rs4680 Val/Met|"Placebo three times per day for eight days~Individuals with the rs4680 val/met genotype"
11311769|NCT02949934|FG003|Participant Flow|Tolcapone/rs4680 Val/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/met genotype"
11311770|NCT02949934|FG004|Participant Flow|Placebo/rs4680 Met/Met|"Placebo three times per day for eight days~Individuals with the rs4680 met/met genotype"
11311771|NCT02949934|FG005|Participant Flow|Tolcapone/rs4680 Met/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 met/met genotype"
11311772|NCT02949934|OG000|Outcome|Placebo/rs4680 Val/Val|"Placebo three times per day for eight days~Individuals with the rs4680 val/val genotype"
11311773|NCT02949934|OG001|Outcome|Tolcapone/rs4680 Val/Val|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/val genotype"
11311774|NCT02949934|OG002|Outcome|Placebo/rs4680 Val/Met|"Placebo three times per day for eight days~Individuals with the rs4680 val/met genotype"
11311775|NCT02949934|OG003|Outcome|Tolcapone/rs4680 Val/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/met genotype"
11311776|NCT02949934|OG004|Outcome|Placebo/rs4680 Met/Met|"Placebo three times per day for eight days~Individuals with the rs4680 met/met genotype"
11311777|NCT02949934|OG005|Outcome|Tolcapone/rs4680 Met/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 met/met genotype"
11311778|NCT02949934|EG000|Reported Event|Placebo/rs4680 Val/Val|"Placebo three times per day for eight days~Individuals with the rs4680 val/val genotype"
11311779|NCT02949934|EG001|Reported Event|Tolcapone/rs4680 Val/Val|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/val genotype"
11311780|NCT02949934|EG002|Reported Event|Placebo/rs4680 Val/Met|"Placebo three times per day for eight days~Individuals with the rs4680 val/met genotype"
11311781|NCT02949934|EG003|Reported Event|Tolcapone/rs4680 Val/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 val/met genotype"
11311782|NCT02949934|EG004|Reported Event|Placebo/rs4680 Met/Met|"Placebo three times per day for eight days~Individuals with the rs4680 met/met genotype"
11311783|NCT02949934|EG005|Reported Event|Tolcapone/rs4680 Met/Met|"Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days~Individuals with the rs4680 met/met genotype"
11311784|NCT02796001|BG000|Baseline|RV16 Infected Volunteers Re-challenged With RV16|"volunteers re-challenged with RV16~human rhinovirus: human rhinovirus"
11311785|NCT02796001|BG001|Baseline|RV16 Infected Volunteers Re-challenged With RV39|"volunteers re-challenged with RV39~human rhinovirus: human rhinovirus"
11311786|NCT02796001|BG002|Baseline|no Intervention|4 volunteers were infected with RV16 and were eligible for re-challenge. Three volunteers declined re-challenge and one was removed from the study prior to re-challenge
11311787|NCT02796001|BG003|Baseline|Total|Total of all reporting groups
11311788|NCT02796001|FG000|Participant Flow|RV16 Infected Volunteers Re-challenged With RV16|"volunteers re-challenged with RV16~human rhinovirus: human rhinovirus"
11311789|NCT02796001|FG001|Participant Flow|RV16 Infected Volunteers Re-challenged With RV39|"volunteers re-challenged with RV39~human rhinovirus: human rhinovirus"
11311790|NCT02796001|FG002|Participant Flow|no Intervention|4 volunteers were infected with RV16 and were eligible to be randomized to re-challenge. Three of these volunteers declined re-challenge and one was removed from the study prior to re-challenge
11311791|NCT02796001|OG000|Outcome|RV16 Infected Volunteers Re-challenged With RV16|"volunteers re-challenged with RV16~human rhinovirus: human rhinovirus"
11311792|NCT02796001|OG001|Outcome|RV16 Infected Volunteers Re-challenged With RV39|"volunteers re-challenged with RV39~human rhinovirus: human rhinovirus"
11311793|NCT02796001|EG000|Reported Event|Volunteers Initially Challenged With RV16|"Volunteers challenged with RV16 to produce RV16 infected volunteers for subsequent arms~Human rhinovirus"
11311794|NCT02796001|EG001|Reported Event|RV16 Infected Volunteers Re-challenged With RV16|"volunteers re-challenged with RV16~human rhinovirus: human rhinovirus"
11311795|NCT02796001|EG002|Reported Event|RV16 Infected Volunteers Re-challenged With RV39|"volunteers re-challenged with RV39~human rhinovirus: human rhinovirus"
11311806|NCT02658656|BG000|Baseline|Exoskeleton + SOC|"Patient will receive exoskeletal-assisted walking device for in home use for 4 months~ReWalk 6.0: Exoskeletal Assisted Walking Device"
11311807|NCT02658656|BG001|Baseline|Standard of Care|Patient will receive standard of care (wheelchair use)
11311808|NCT02658656|BG002|Baseline|Total|Total of all reporting groups
11311809|NCT02658656|FG000|Participant Flow|Exoskeleton + Standard of Care (SOC)|"Patient will receive exoskeletal-assisted walking device for in home use for 4 months~ReWalk 6.0: Exoskeletal Assisted Walking Device"
11311810|NCT02658656|FG001|Participant Flow|Standard of Care|Patient will receive standard of care (wheelchair use)
11311811|NCT02658656|FG002|Participant Flow|Screen Failures|Consented participants who failed screening and were not randomized.
11311812|NCT02658656|OG000|Outcome|Exoskeleton + SOC|"Patient will receive exoskeletal-assisted walking device for in home use for 4 months~ReWalk 6.0: Exoskeletal Assisted Walking Device"
11311813|NCT02658656|OG001|Outcome|Standard of Care|Patient will receive standard of care (wheelchair use)
11311814|NCT02658656|EG000|Reported Event|Exoskeleton + SOC|"Patient will receive exoskeletal-assisted walking device for in home use for 4 months~ReWalk 6.0: Exoskeletal Assisted Walking Device"
11311815|NCT02658656|EG001|Reported Event|Standard of Care|Patient will receive standard of care (wheelchair use)
11311816|NCT02658656|EG002|Reported Event|Prior to Randomization|Consented patients prior to randomization
11311817|NCT02536170|BG000|Baseline|L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital."
11311818|NCT02536170|BG001|Baseline|Loading Dose and L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.~L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg"
11311819|NCT02536170|BG002|Baseline|Placebo|"Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital."
11311820|NCT02536170|BG003|Baseline|Total|Total of all reporting groups
11311821|NCT02536170|FG000|Participant Flow|L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital."
11311822|NCT02536170|FG001|Participant Flow|Loading Dose and L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.~L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg"
11311823|NCT02536170|FG002|Participant Flow|Placebo|"Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital."
11311824|NCT02536170|OG000|Outcome|L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital."
11311825|NCT02536170|OG001|Outcome|Loading Dose and L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.~L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg"
11311826|NCT02536170|OG002|Outcome|Placebo|"Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital."
11311827|NCT02536170|EG000|Reported Event|L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital."
11311828|NCT02536170|EG001|Reported Event|Loading Dose and L-Arginine|"Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.~L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg"
11311829|NCT02536170|EG002|Reported Event|Placebo|"Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital.~Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital."
11311830|NCT02094261|BG000|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
11311831|NCT02094261|FG000|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
11311832|NCT02094261|OG000|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
11311833|NCT02094261|EG000|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
11311834|NCT01920932|BG000|Baseline|AEPA/CAPDac|"Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:~2 cycles of AEPA chemotherapy:~(A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15),~Followed by 4 cycles of CAPDac:~(C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.).~Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given."
11311835|NCT01920932|FG000|Participant Flow|AEPA/CAPDac|"Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:~2 cycles of AEPA chemotherapy:~(A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15),~Followed by 4 cycles of CAPDac:~(C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.).~Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given."
11311836|NCT01920932|OG000|Outcome|AEPA Chemotherapy|Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants receive 2 cycles of AEPA chemotherapy (brentuximab vedotin, etoposide, prednisone, doxorubicin)
11311837|NCT01920932|OG000|Outcome|AEPA/CAPDac|"Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:~2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.).~Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given."
11311838|NCT01920932|OG000|Outcome|AEPA/CAPDac|"Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:~2 cycles of AEPA chemotherapy:~(A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15),~Followed by 4 cycles of CAPDac:~(C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.).~Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given."
11311839|NCT01920932|OG000|Outcome|Cycle 1 - Grade 2|"Participants receive AEPA regimen for 2 cycles (cycle length 28 days)~(A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given."
11311840|NCT01920932|OG001|Outcome|Cycle 1 - Grade 3-4|"Participants receive AEPA regimen for 2 cycles (cycle length 28 days)~(A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given."
11311841|NCT01920932|OG002|Outcome|Cycle 2 - Grade 2|"Participants receive AEPA regimen for 2 cycles (cycle length 28 days)~(A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given."
11311842|NCT01920932|OG003|Outcome|Cycle 2 - Grade 3-4|"Participants receive AEPA regimen for 2 cycles (cycle length 28 days)~(A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m^2 IV (P) Prednisone 60 mg/m^2/day PO (orally) (A) Doxorubicin 40 mg/m^2 IV~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given."
11311843|NCT01920932|OG004|Outcome|Cycle 3 - Grade 2|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311844|NCT01920932|OG005|Outcome|Cycle 3 - Grade 3-4|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311845|NCT01920932|OG006|Outcome|Cycle 4 - Grade 2|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311846|NCT01920932|OG007|Outcome|Cycle 4 - Grade 3-4|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311847|NCT01920932|OG008|Outcome|Cycle 5 - Grade 2|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311848|NCT01920932|OG009|Outcome|Cycle 5 - Grade 3-4|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311849|NCT01920932|OG010|Outcome|Cycle 6 - Grade 2|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311850|NCT01920932|OG011|Outcome|Cycle 6 - Grade 3-4|"Participants receive CAPDac regimen for 4 cycles (cycle length 21 days):~(C) Cyclophosphamide IV 500 mg/m^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m^2/day PO (Dac) Dacarbazine 250 mg/m^2 IV"
11311851|NCT01920932|OG000|Outcome|AEPA/CAPDac|Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants received 2 cycles of AEPA/CAPDac chemotherapy and reported symptoms distress scale (SDS).
11311852|NCT01920932|OG001|Outcome|HOD99 Unfavorable Risk 2 Arm (UR2)|Ann Arbor stage IIB, IIIB, or any IV risk participants received 12 weeks Stanford V Chemotherapy
11311853|NCT01920932|OG000|Outcome|AEPA/CAPDac|Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants received 2 cycles of AEPE/CAPDac chemotherapy and reported symptoms distress scale (SDS).
11311854|NCT01920932|EG000|Reported Event|AEPA/CAPDac|"Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:~2 cycles of AEPA chemotherapy:~(A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m^2 IV days 1-5, (P) Prednisone 60 mg/m^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m^2 IV days 1 and 15),~Followed by 4 cycles of CAPDac:~(C) Cyclophosphamide 500 mg/m^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m^2 IV days 1-3.).~Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.~For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given."
11311855|NCT01801189|BG000|Baseline|Pregabalin|"Single, 300 mg pre-operative oral dose of Pregabalin.~Pregabalin: One 300 mg oral dose of Pregabalin given before surgery."
11311856|NCT01801189|BG001|Baseline|Sugar Pill|"Single, placebo pre-operative dose.~Placebo (for Pregabalin): One oral dose of placebo given before surgery."
11311857|NCT01801189|BG002|Baseline|Total|Total of all reporting groups
11311858|NCT01801189|FG000|Participant Flow|Pregabalin|"Single, 300 mg pre-operative oral dose of Pregabalin.~Pregabalin: One 300 mg oral dose of Pregabalin given before surgery."
11311859|NCT01801189|FG001|Participant Flow|Sugar Pill|"Single, placebo pre-operative dose.~Placebo (for Pregabalin): One oral dose of placebo given before surgery."
11311860|NCT01801189|OG000|Outcome|Pregabalin|"Single, 300 mg pre-operative oral dose of Pregabalin.~Pregabalin: One 300 mg oral dose of Pregabalin given before surgery."
11311861|NCT01801189|OG001|Outcome|Sugar Pill|"Single, placebo pre-operative dose.~Placebo (for Pregabalin): One oral dose of placebo given before surgery."
11311862|NCT01801189|EG000|Reported Event|Pregabalin|"Single, 300 mg pre-operative oral dose of Pregabalin.~Pregabalin: One 300 mg oral dose of Pregabalin given before surgery."
11311863|NCT01801189|EG001|Reported Event|Sugar Pill|"Single, placebo pre-operative dose.~Placebo (for Pregabalin): One oral dose of placebo given before surgery."
11311864|NCT01667081|BG000|Baseline|GZR 100 mg + EBR 50 mg +/- RBV|Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.
11311865|NCT01667081|BG001|Baseline|Other GZR Regimen|Participants previously received at least one dose of GZR in a prior study
11311866|NCT01667081|BG002|Baseline|Total|Total of all reporting groups
11311867|NCT01667081|FG000|Participant Flow|Grazoprevir (GZR) 100 mg + Elbasvir (EBR) 50 mg +/- Ribavirin (RBV)|Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.
11311868|NCT01667081|FG001|Participant Flow|Other GZR Regimen|Participants previously received at least one dose of GZR in a prior study
11311869|NCT01667081|OG000|Outcome|GZR 100 mg + EBR 50 mg +/- RBV|Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.
11311870|NCT01667081|OG001|Outcome|Other GZR Regimen|Participants previously received at least one dose of GZR in a prior study
11311871|NCT01667081|OG000|Outcome|EBR/GZR +/- RBV: NS3 RASs|Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS3 RASs
11311872|NCT01667081|OG001|Outcome|EBR/GZR +/- RBV: NS5A RASs|Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS5A RASs
11311873|NCT01667081|OG002|Outcome|EBR/GZR +/-RBV: Both NS3 and NS5A RASs|Participants previously received EBR and GZR with or without RBV in a prior study and had both treatment-emergent NS3 and NS5A RASs
11311874|NCT01667081|OG003|Outcome|GZR + Pegylated Interferon/Ribavirin (PR): NS3 RASs|Participants previously received GZR and PR for 12 weeks in a prior study and had treatment-emergent NS3 RASs
11311875|NCT01667081|OG000|Outcome|EBR/GZR+/- RBV: NS3 RASs|Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS3 RASs
11311876|NCT01667081|OG002|Outcome|EBR/GZR +/-RVB: Both NS3 and NS5A RASs|Participants previously received EBR and GZR with or without RBV in a prior study and had both treatment-emergent NS3 and NS5A RASs
11311877|NCT01667081|OG003|Outcome|GZR + RBV or PR: NS3 RASs|Participants previously received GZR and RBV or PR for 12 weeks in a prior study and had treatment-emergent NS3 RASs
11311878|NCT01667081|OG000|Outcome|EBR/GZR: NS3 RASs|Participants previously received EBR and GZR in a prior study and had treatment-emergent NS3 RASs
11311879|NCT01667081|OG001|Outcome|EBR/GZR: NS5A RASs|Participants previously received EBR and GZR in a prior study and had treatment-emergent NS5A RASs
11311880|NCT01667081|OG002|Outcome|EBR/GZR: Both NS3 and NS5A RASs|Participants previously received EBR and GZR in a prior study and had both treatment-emergent NS3 and NS5A RASs
11311881|NCT01667081|EG000|Reported Event|GZR 100 mg + EBR 50 mg +/- RBV|Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.
11311882|NCT01667081|EG001|Reported Event|Other GZR Regimen|Participants previously received at least one dose of GZR in a prior study
11311883|NCT01667081|EG002|Reported Event|Non-GZR Regimen|Participants received a non-GZR regimen in a prior study
11311884|NCT01197950|BG000|Baseline|Manual Acupuncture|"Manual stimulation~Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour."
11311885|NCT01197950|BG001|Baseline|Electro Acupuncture|"Electrical and manual stimulation~Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold."
11311886|NCT01197950|BG002|Baseline|Standard Care|No acupunture
11311887|NCT01197950|BG003|Baseline|Total|Total of all reporting groups
11311888|NCT01197950|FG000|Participant Flow|Manual Acupuncture|"Manual stimulation~Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour."
11311889|NCT01197950|FG001|Participant Flow|Electro Acupuncture|"Electrical and manual stimulation~Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold."
11311890|NCT01197950|FG002|Participant Flow|Standard Care|Standard Care No acupucture
11311891|NCT01197950|OG000|Outcome|Manual Acupuncture|"Manual stimulation~Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour."
11311892|NCT01197950|OG001|Outcome|Electro Acupuncture|"Electrical and manual stimulation~Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold."
11311893|NCT01197950|OG002|Outcome|Standard Care|Standard care
11311894|NCT01197950|EG000|Reported Event|Manual Acupuncture|"Manual stimulation~Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour."
11311895|NCT01197950|EG001|Reported Event|Electro Acupuncture|"Electrical and manual stimulation~Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold."
11311896|NCT01197950|EG002|Reported Event|Standard Care|Standard care - no acupuncture treatment at all
11333221|NCT03510663|FG004|Participant Flow|Sequence 5 (ABCD)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333222|NCT03510663|FG005|Participant Flow|Sequence 6 (CADB)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333223|NCT03510663|FG006|Participant Flow|Sequence 7 (BDAC)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333224|NCT03510663|FG007|Participant Flow|Sequence 8 (DCBA)|"Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence.~A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin~OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period."
11333225|NCT03510663|OG000|Outcome|OPC-61815 16 mg|OPC-61815 16 mg was intravenously administered once a week.
11333226|NCT03510663|OG001|Outcome|OPC-61815 32 mg|OPC-61815 32 mg was intravenously administered once a week.
11333227|NCT03510663|OG002|Outcome|Moxifloxacin|400 mg tablet was orally administrated once a week.
11333228|NCT03510663|OG003|Outcome|Placebo|Placebo was intravenously administered once a week.
11333229|NCT03510663|EG000|Reported Event|OPC-61815 16 mg|OPC-61815 16 mg was intravenously administered once a week.
11333230|NCT03510663|EG001|Reported Event|OPC-61815 32 mg|OPC-61815 32 mg was intravenously administered once a week.
11333231|NCT03510663|EG002|Reported Event|Moxifloxacin|400 mg tablet was orally administrated once a week.
11333232|NCT03510663|EG003|Reported Event|Placebo|Placebo was intravenously administered once a week.
11333233|NCT03510715|BG000|Baseline|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Participants with BW <50 kg received SC injection of alirocumab 75 mg Q2W for 48 weeks. Alirocumab dose was up-titrated to 150 mg Q2W from Week 12 in case of increase in BW with BW >=50 kg.
11333234|NCT03510715|BG001|Baseline|Alirocumab 150 mg Q2W|Participants with BW >=50 kg received SC injection of alirocumab 150 mg Q2W for 48 weeks.
11333235|NCT03510715|BG002|Baseline|Total|Total of all reporting groups
11333236|NCT03510715|FG000|Participant Flow|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Participants with body weight (BW) less than (<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 75 milligrams (mg) every 2 weeks (Q2W) for 48 weeks. Alirocumab dose was up-titrated to 150 mg Q2W from Week 12 in case of increase in BW with BW greater than or equal to [>=] 50 kg.
11333237|NCT03510715|FG001|Participant Flow|Alirocumab 150 mg Q2W|Participants with BW >=50 kg received SC injection of alirocumab 150 mg Q2W for 48 weeks.
11333238|NCT03510715|OG000|Outcome|Alirocumab|All participants who received either 75 mg (BW <50 kg) or 150 mg (BW >=50 kg) alirocumab subcutaneously Q2W for 48 weeks.
11333239|NCT03510715|OG000|Outcome|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Participants with BW <50 kg received SC injection of alirocumab 75 mg Q2W for 48 weeks. Alirocumab dose was up-titrated to 150 mg Q2W from Week 12 in case of increase in BW with BW >=50 kg.
11333240|NCT03510715|OG001|Outcome|Alirocumab 150 mg Q2W|Participants with BW >=50 kg received SC injection of alirocumab 150 mg Q2W for 48 weeks.
11333241|NCT03510715|EG000|Reported Event|Alirocumab 75 mg Q2W/up to 150 mg Q2W|Participants with BW <50 kg received SC injection of alirocumab 75 mg Q2W for 48 weeks. Alirocumab dose was up-titrated to 150 mg Q2W from Week 12 in case of increase in BW with BW >=50 kg.
11333242|NCT03510715|EG001|Reported Event|Alirocumab 150 mg Q2W|Participants with BW >=50 kg received SC injection of alirocumab 150 mg Q2W for 48 weeks.
11333243|NCT03510910|BG000|Baseline|Acetaminophen Along With a Reduced Quantity of Percocet|"Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID)~Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333244|NCT03510910|BG001|Baseline|Percocet Only|"Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333245|NCT03510910|BG002|Baseline|Total|Total of all reporting groups
11217662|NCT02315352|FG006|Participant Flow|Cesol® Then L-PZQ Then Rac-PZQ (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Rac -PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217663|NCT02315352|FG007|Participant Flow|Cesol® Then Rac-PZQ Then L-PZQ (Day 2)|Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217664|NCT02315352|OG000|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217665|NCT02315352|OG001|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217666|NCT02315352|OG002|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217667|NCT02315352|OG003|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217668|NCT02315352|OG004|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
11217669|NCT02315352|EG000|Reported Event|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217670|NCT02315352|EG001|Reported Event|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
11217671|NCT02315352|EG002|Reported Event|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217672|NCT02315352|EG003|Reported Event|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
11217673|NCT02315352|EG004|Reported Event|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
11217674|NCT02315430|BG000|Baseline|Cabozantinib|Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
11217675|NCT02315430|FG000|Participant Flow|Cabozantinib|Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
11217676|NCT02315430|OG000|Outcome|Cabozantinib|Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
11217677|NCT02315430|EG000|Reported Event|Cabozantinib|Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
11217678|NCT02315560|BG000|Baseline|Tibial Nerve Stimulation|"The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit~TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children"
11311897|NCT00846742|BG000|Baseline|Stanford V Chemotherapy|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
11311898|NCT00846742|FG000|Participant Flow|Stanford V Chemotherapy|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
11311899|NCT00846742|OG000|Outcome|Stanford V Chemotherapy|Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.
11311900|NCT00846742|OG000|Outcome|Stanford V Chemotherapy|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
11311901|NCT00846742|EG000|Reported Event|Stanford V Chemotherapy|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
11311902|NCT00634504|BG000|Baseline|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
11311903|NCT00634504|BG001|Baseline|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
11311904|NCT00634504|BG002|Baseline|Total|Total of all reporting groups
11311905|NCT00634504|FG000|Participant Flow|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"Drug: High-dose methotrexate (HDMTX) and leucovorin (LV) with a single bolus intravenous injection of 50 units/kg glucarpidase over 5 minutes.~HDMTX followed by intravenous LV administered at doses recommended in the clinical treatment protocols.~LV doses administered as recommended in the package insert for Leucovorin Calcium USP for patients with delayed early MTX elimination and/or evidence of acute renal injury, and should be based upon the pre-glucarpidase MTX concentration. LV doses are maintained for at least 48 hours after dosing with glucarpidase. After this it may be administered at doses recommended in the clinical treatment protocols and existing labeling for LV based on post-Voraxaze MTX concentrations. Patients required IV LV rescue therapy with either ≥15 mg or ≥10 mg/m2 every 6 hours.~Other Names:~Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin"
11311906|NCT00634504|FG001|Participant Flow|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate (HDMTX) and leucovorin (LV) without glucarpidase~HDMTX followed by intravenous LV should be administered at doses recommended in the clinical treatment protocols and as per standard of care. LV should be given every 6 hours at a dose of ≤25 mg/m2."
11311907|NCT00634504|OG000|Outcome|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
11311908|NCT00634504|OG001|Outcome|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
11311909|NCT00634504|EG000|Reported Event|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
11311910|NCT00634504|EG001|Reported Event|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
11333246|NCT03510910|FG000|Participant Flow|Acetaminophen Along With a Reduced Quantity of Percocet|"Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID)~Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11311920|NCT00392821|BG000|Baseline|Phase 1 Dose Level 1|sorafenib 400 mg BID and everolimus 35 mg once weekly
11311921|NCT00392821|BG001|Baseline|Phase 1 Dose Level -1|Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
11311922|NCT00392821|BG002|Baseline|Phase II|200 mg PO BID and everolimus 35 mg PO once weekly
11311923|NCT00392821|BG003|Baseline|Total|Total of all reporting groups
11311924|NCT00392821|FG000|Participant Flow|Phase 1 Dose Level 1|sorafenib 400 mg BID and everolimus 35 mg once weekly
11311925|NCT00392821|FG001|Participant Flow|Phase 1 Dose Level -1|Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
11311926|NCT00392821|FG002|Participant Flow|Phase II|200 mg PO BID and everolimus 35 mg PO once weekly
11311927|NCT00392821|OG000|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
11311928|NCT00392821|EG000|Reported Event|Phase 1 Dose Level 1|sorafenib 400 mg BID and everolimus 35 mg once weekly
11311929|NCT00392821|EG001|Reported Event|Phase 1 Dose Level -1|Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
11311930|NCT00392821|EG002|Reported Event|Phase II|200 mg PO BID and everolimus 35 mg PO once weekly
11311931|NCT00352027|BG000|Baseline|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
11311932|NCT00352027|FG000|Participant Flow|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
11311933|NCT00352027|OG000|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
11311934|NCT00352027|OG000|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
11311935|NCT00352027|OG001|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
11311936|NCT00352027|OG002|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
11311937|NCT00352027|OG003|Outcome|After Radiation|Evaluation completed following radiation therapy.
11311938|NCT00352027|OG004|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
11311939|NCT00352027|OG000|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
11311940|NCT00352027|OG001|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
11311941|NCT00352027|OG002|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
11311942|NCT00352027|OG003|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
11311943|NCT00352027|OG004|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
11311944|NCT00352027|OG000|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
11311945|NCT00352027|OG000|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
11311946|NCT00352027|OG001|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
11311947|NCT00352027|OG001|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
11311948|NCT00352027|OG000|Outcome|HOD05 - Grade 2|Participants in current study.
11311949|NCT00352027|OG001|Outcome|HOD05 - Grade 3|Participants in current study.
11311950|NCT00352027|OG002|Outcome|HOD05 - Grade 4|Participants in current study.
11311951|NCT00352027|OG003|Outcome|HOD05 - Grade 5|Participants in current study.
11311952|NCT00352027|OG004|Outcome|HOD99 - Grade 2|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
11311953|NCT00352027|OG005|Outcome|HOD99 - Grade 3|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
11311954|NCT00352027|OG006|Outcome|HOD99 - Grade 4|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
11311955|NCT00352027|OG007|Outcome|HOD99 - Grade 5|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
11311956|NCT00352027|EG000|Reported Event|Stanford V Chemotherapy|"Intermediate risk single arm study defined as~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
11311957|NCT00104676|BG000|Baseline|Arm I|"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered"
11311958|NCT00104676|BG001|Baseline|Arm II|"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered~ifosfamide: Given in a dose-dense sequential fashion~oxaliplatin: Given in a dose-dense sequential fashion~paclitaxel: Given in a dose-dense sequential fashion"
11311959|NCT00104676|BG002|Baseline|Total|Total of all reporting groups
11311960|NCT00104676|FG000|Participant Flow|Arm I|"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered"
11311961|NCT00104676|FG001|Participant Flow|Arm II|"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered~ifosfamide: Given in a dose-dense sequential fashion~oxaliplatin: Given in a dose-dense sequential fashion~paclitaxel: Given in a dose-dense sequential fashion"
11311962|NCT00104676|OG000|Outcome|Arm I|"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered"
11311963|NCT00104676|OG001|Outcome|Arm II|"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered~ifosfamide: Given in a dose-dense sequential fashion~oxaliplatin: Given in a dose-dense sequential fashion~paclitaxel: Given in a dose-dense sequential fashion"
11311964|NCT00104676|EG000|Reported Event|Arm I|"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered"
11311965|NCT00104676|EG001|Reported Event|Arm II|"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered~ifosfamide: Given in a dose-dense sequential fashion~oxaliplatin: Given in a dose-dense sequential fashion~paclitaxel: Given in a dose-dense sequential fashion"
11333247|NCT03510910|FG001|Participant Flow|Percocet Only|"Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333248|NCT03510910|OG000|Outcome|Acetaminophen Along With a Reduced Quantity of Percocet|"Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID)~Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333249|NCT03510910|OG001|Outcome|Percocet Only|"Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333250|NCT03510910|EG000|Reported Event|Acetaminophen Along With a Reduced Quantity of Percocet|"Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID)~Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333251|NCT03510910|EG001|Reported Event|Percocet Only|"Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
11333252|NCT03511001|BG000|Baseline|E-Cigarette|"6 weeks of JUUL electronic cigarettes~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333253|NCT03511001|BG001|Baseline|Assessment Only|"6 weeks of smoking as usual~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333254|NCT03511001|BG002|Baseline|Total|Total of all reporting groups
11333255|NCT03511001|FG000|Participant Flow|E-Cigarette|"6 weeks of JUUL electronic cigarettes~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333256|NCT03511001|FG001|Participant Flow|Assessment Only|"6 weeks of smoking as usual~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333257|NCT03511001|OG000|Outcome|E-Cigarette|"6 weeks of JUUL electronic cigarettes~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333258|NCT03511001|OG001|Outcome|Assessment Only|"6 weeks of smoking as usual~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333259|NCT03511001|EG000|Reported Event|E-Cigarette|"6 weeks of JUUL electronic cigarettes~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333260|NCT03511001|EG001|Reported Event|Assessment Only|"6 weeks of smoking as usual~E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual"
11333261|NCT03511053|BG000|Baseline|All Participants|"Epidural Lavage followed by Lumbar Epidural Steroid Injection~Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection."
11333262|NCT03511053|FG000|Participant Flow|All Participants|"Epidural Lavage followed by Lumbar Epidural Steroid Injection~Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection."
11333263|NCT03511053|OG000|Outcome|All Participants|"Epidural Lavage followed by Lumbar Epidural Steroid Injection~Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection."
11333264|NCT03511053|EG000|Reported Event|All Participants|"Epidural Lavage followed by Lumbar Epidural Steroid Injection~Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection."
11333265|NCT03511105|BG000|Baseline|Placebo|Participants received two tablets of placebo in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of placebo was administered 10 hours after LPS and saline challenge.
11333266|NCT03511105|BG001|Baseline|GSK2798745|Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge.
11333267|NCT03511105|BG002|Baseline|Total|Total of all reporting groups
11333268|NCT03511105|FG000|Participant Flow|Placebo|Participants received two tablets of placebo in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of placebo was administered 10 hours after LPS and saline challenge.
11333269|NCT03511105|FG001|Participant Flow|GSK2798745|Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge.
11333270|NCT03511105|OG000|Outcome|Placebo|Participants received two tablets of placebo in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of placebo was administered 10 hours after LPS and saline challenge.
11333271|NCT03511105|OG001|Outcome|GSK2798745|Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge.
11333272|NCT03511105|OG000|Outcome|GSK2798745|Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge.
11333273|NCT03511105|EG000|Reported Event|Placebo|Participants received two tablets of placebo in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of placebo was administered 10 hours after LPS and saline challenge.
11333274|NCT03511105|EG001|Reported Event|GSK2798745|Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge.
11333275|NCT03511326|BG000|Baseline|Luxerm®|Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
11333276|NCT03511326|FG000|Participant Flow|Luxerm®|Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
11333277|NCT03511326|OG000|Outcome|Luxerm®|Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
11333278|NCT03511326|EG000|Reported Event|Luxerm®|Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
11333279|NCT03511378|BG000|Baseline|Lupin's Pegfilgrastim|"6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.~Lupin's Pegfilgrastim: Administration of Pegfilgrastim"
11311966|NCT04426500|BG000|Baseline|Robotic -Guided Transversus Abdominus Plane (RTAP) Block|"30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies"
11311967|NCT04426500|BG001|Baseline|Ultrasound-guided Transversus Abdominus Plane (UTAP) Block|"30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies"
11311968|NCT04426500|BG002|Baseline|Placebo/Local Anesthesia|Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
11311969|NCT04426500|BG003|Baseline|Total|Total of all reporting groups
11311970|NCT04426500|FG000|Participant Flow|Placebo/Local Anesthesia|Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
11311971|NCT04426500|FG001|Participant Flow|Ultrasound-guided Transversus Abdominus Plane (UTAP) Block|"30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies"
11311972|NCT04426500|FG002|Participant Flow|Robotic -Guided Transversus Abdominus Plane (RTAP) Block|"30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies"
11311973|NCT04426500|OG000|Outcome|Placebo/Local Anesthesia|Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
11311974|NCT04426500|OG001|Outcome|Ultrasound-guided Transversus Abdominus Plane (UTAP) Block|"30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies"
11311975|NCT04426500|OG002|Outcome|Robotic -Guided Transversus Abdominus Plane (RTAP) Block|"30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies"
11311976|NCT04426500|EG000|Reported Event|Placebo/Local Anesthesia|Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
11311977|NCT04426500|EG001|Reported Event|Ultrasound-guided Transversus Abdominus Plane (UTAP) Block|"30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies"
11311978|NCT04426500|EG002|Reported Event|Robotic -Guided Transversus Abdominus Plane (RTAP) Block|"30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).~Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds~Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies"
11311979|NCT04042103|BG000|Baseline|Tapinarof (DMVT-505) Cream, 1%|"Tapinarof (DMVT-505) cream, 1% applied topically once daily~Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily"
11311980|NCT04042103|FG000|Participant Flow|Tapinarof (DMVT-505) Cream, 1%|"Tapinarof (DMVT-505) cream, 1% applied topically once daily~Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily"
11311981|NCT04042103|OG000|Outcome|Tapinarof (DMVT-505) Cream, 1%|"Tapinarof (DMVT-505) cream, 1% applied topically once daily~Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily"
11311982|NCT04042103|EG000|Reported Event|Tapinarof (DMVT-505) Cream, 1%|"Tapinarof (DMVT-505) cream, 1% applied topically once daily~Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily"
11311983|NCT04004208|BG000|Baseline|Aflibercept 0.4 mg|One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated.
11311984|NCT04004208|BG001|Baseline|Laser Photocoagulation|Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated.
11311985|NCT04004208|BG002|Baseline|Total|Total of all reporting groups
11311986|NCT04004208|FG000|Participant Flow|Aflibercept 0.4 mg|One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated.
11311987|NCT04004208|FG001|Participant Flow|Laser Photocoagulation|Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated.
11311988|NCT04004208|OG000|Outcome|Aflibercept 0.4 mg|One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated.
11311989|NCT04004208|OG001|Outcome|Laser Photocoagulation|Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated.
11311990|NCT04004208|EG000|Reported Event|Aflibercept 0.4 mg|One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated.
11311991|NCT04004208|EG001|Reported Event|Laser Photocoagulation|Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated.
11333280|NCT03511378|BG001|Baseline|Neulasta®|"6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.~Neulasta®: Administration of Neulasta®"
11333281|NCT03511378|BG002|Baseline|Total|Total of all reporting groups
11333282|NCT03511378|FG000|Participant Flow|Lupin's Pegfilgrastim|"6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.~Lupin's Pegfilgrastim: Administration of Pegfilgrastim"
11333283|NCT03511378|FG001|Participant Flow|Neulasta®|"6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.~Neulasta®: Administration of Neulasta®"
11333284|NCT03511378|OG000|Outcome|Lupin's Pegfilgrastim|"6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.~Lupin's Pegfilgrastim: Administration of Pegfilgrastim"
11333285|NCT03511378|OG001|Outcome|Neulasta®|"6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.~Neulasta®: Administration of Neulasta®"
11333286|NCT03511378|EG000|Reported Event|Lupin's Pegfilgrastim|"6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.~Lupin's Pegfilgrastim: Administration of Pegfilgrastim"
11333287|NCT03511378|EG001|Reported Event|Neulasta®|"6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.~Neulasta®: Administration of Neulasta®"
11333288|NCT03511521|BG000|Baseline|NPH Insulin|"NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses:~Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; >80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone.~NPH Insulin: Intermediate acting insulin~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333289|NCT03511521|BG001|Baseline|Basal/Bolus Insulin|"Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U [units]/kg) according to the Prednisone dose (mg/day) as follows:~Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone >80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333290|NCT03511521|BG002|Baseline|Total|Total of all reporting groups
11333291|NCT03511521|FG000|Participant Flow|NPH Insulin|"NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses:~Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; >80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone.~NPH Insulin: Intermediate acting insulin~glargine: basal insulin~Insulin Aspart: prandial insulin"
11341897|NCT03691948|BG000|Baseline|ROPEs|Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
10822274|NCT00075725|FG003|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822275|NCT00075725|FG004|Participant Flow|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822276|NCT00075725|FG005|Participant Flow|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822277|NCT00075725|FG006|Participant Flow|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822278|NCT00075725|FG007|Participant Flow|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822279|NCT00075725|FG008|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822280|NCT00075725|FG009|Participant Flow|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822281|NCT00075725|FG010|Participant Flow|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
11311992|NCT03817190|BG000|Baseline|Placebo|Placebo (4 placebo capsules) orally administered once daily for 16 weeks.
10842476|NCT00246740|FG000|Participant Flow|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
11311993|NCT03817190|BG001|Baseline|DS107 2000mg|2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.
11311994|NCT03817190|BG002|Baseline|Total|Total of all reporting groups
11311995|NCT03817190|FG000|Participant Flow|Placebo|Placebo (4 placebo capsules) orally administered once daily for 16 weeks.
11311996|NCT03817190|FG001|Participant Flow|DS107 2000mg|2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.
11311997|NCT03817190|OG000|Outcome|Placebo|Placebo (4 placebo capsules) orally administered once daily for 16 weeks.
11311998|NCT03817190|OG001|Outcome|DS107 2000mg|2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.
11311999|NCT03817190|EG000|Reported Event|Placebo|Placebo (4 placebo capsules) orally administered once daily for 16 weeks.
11312000|NCT03817190|EG001|Reported Event|DS107 2000mg|2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.
11312001|NCT03447782|BG000|Baseline|NDPH Persistent|"Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).~Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.~Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder"
11312002|NCT03447782|FG000|Participant Flow|NDPH Persistent|"Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).~Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.~Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder"
11312003|NCT03447782|OG000|Outcome|NDPH Persistent|"Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).~Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.~Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder"
11312004|NCT03447782|EG000|Reported Event|NDPH Persistent|"Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).~Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.~Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder"
11333292|NCT03511521|FG001|Participant Flow|Basal/Bolus Insulin|"Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U [units]/kg) according to the Prednisone dose (mg/day) as follows:~Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone >80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333293|NCT03511521|OG000|Outcome|NPH Insulin|"NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses:~Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; >80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone.~NPH Insulin: Intermediate acting insulin~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333294|NCT03511521|OG001|Outcome|Basal/Bolus Insulin|"Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U [units]/kg) according to the Prednisone dose (mg/day) as follows:~Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone >80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333295|NCT03511521|EG000|Reported Event|NPH Insulin|"NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses:~Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; >80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone.~NPH Insulin: Intermediate acting insulin~glargine: basal insulin~Insulin Aspart: prandial insulin"
11335866|NCT03557801|FG001|Participant Flow|Mammography With Community Health Worker (Individual)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11341898|NCT03691948|BG001|Baseline|Control|Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
11341899|NCT03691948|BG002|Baseline|Total|Total of all reporting groups
11312005|NCT03041311|BG000|Baseline|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312006|NCT03041311|BG001|Baseline|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator."
11312007|NCT03041311|BG002|Baseline|Total|Total of all reporting groups
11312008|NCT03041311|FG000|Participant Flow|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
10822282|NCT00075725|FG011|Participant Flow|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822283|NCT00075725|OG000|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822284|NCT00075725|OG001|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822285|NCT00075725|OG002|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822286|NCT00075725|OG003|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822287|NCT00075725|OG004|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822288|NCT00075725|OG005|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822289|NCT00075725|OG006|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10842477|NCT00246740|FG001|Participant Flow|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
10822290|NCT00075725|OG007|Outcome|Prenisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822291|NCT00075725|OG008|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822292|NCT00075725|OG009|Outcome|Prenisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822293|NCT00075725|OG010|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822294|NCT00075725|OG005|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822295|NCT00075725|OG007|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822296|NCT00075725|OG006|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822297|NCT00075725|OG009|Outcome|Prednisone, Capizzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822298|NCT00075725|OG009|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10842478|NCT00246740|OG000|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
11312009|NCT03041311|FG001|Participant Flow|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312010|NCT03041311|OG000|Outcome|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312011|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312012|NCT03041311|OG000|Outcome|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator"
11312013|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312014|NCT03041311|OG000|Outcome|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator."
11312015|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator."
11312016|NCT03041311|OG000|Outcome|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11335867|NCT03557801|FG002|Participant Flow|Mammography With Community Health Worker (Group)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
10822299|NCT00075725|OG011|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822300|NCT00075725|EG000|Reported Event|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822301|NCT00075725|EG001|Reported Event|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822302|NCT00075725|EG002|Reported Event|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822303|NCT00075725|EG003|Reported Event|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822304|NCT00075725|EG004|Reported Event|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822305|NCT00075725|EG005|Reported Event|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822306|NCT00075725|EG006|Reported Event|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822307|NCT00075725|EG007|Reported Event|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
11312017|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients will receive placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg will be administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312018|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312019|NCT03041311|OG001|Outcome|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients receives maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312020|NCT03041311|EG000|Reported Event|Trilaciclib+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11335868|NCT03557801|OG000|Outcome|Standard of Care Mammography|Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.
11335869|NCT03557801|OG001|Outcome|Mammography With Community Health Worker (Individual)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11335870|NCT03557801|OG002|Outcome|Mammography With Community Health Worker (Group)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11335871|NCT03557801|EG000|Reported Event|Standard of Care Mammography|Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.
11335872|NCT03557801|EG001|Reported Event|Mammography With Community Health Worker (Individual)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11335873|NCT03557801|EG002|Reported Event|Mammography With Community Health Worker (Group)|Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
11335874|NCT03558061|BG000|Baseline|Active|ALK4290 800 mg daily
11335875|NCT03558061|FG000|Participant Flow|Active|ALK4290 800 mg daily
11335876|NCT03558061|OG000|Outcome|Active|ALK4290 800 mg daily
11335877|NCT03558061|EG000|Reported Event|Active|ALK4290 800 mg daily
11335878|NCT03558074|BG000|Baseline|Active|ALK4290 800 mg daily
11335879|NCT03558074|FG000|Participant Flow|Active|ALK4290 800 mg daily
11335880|NCT03558074|OG000|Outcome|Active|ALK4290 800 mg daily
11335881|NCT03558074|OG000|Outcome|Active|"ALK4290 800 mg daily (400 mg tablet twice a day)~ALK4290: ALK4290 400 mg tablet twice a day"
11335882|NCT03558074|EG000|Reported Event|Active|"ALK4290 800 mg daily (400 mg tablet twice a day)~ALK4290: ALK4290 400 mg tablet twice a day"
10822308|NCT00075725|EG008|Reported Event|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822309|NCT00075725|EG009|Reported Event|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822310|NCT00075725|EG010|Reported Event|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
10822311|NCT00075725|EG011|Reported Event|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
10822312|NCT00075764|BG000|Baseline|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
10822313|NCT00075764|BG001|Baseline|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
10822314|NCT00075764|BG002|Baseline|Total|Total of all reporting groups
10822315|NCT00075764|FG000|Participant Flow|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
10822316|NCT00075764|FG001|Participant Flow|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
10822317|NCT00075764|OG000|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
10822318|NCT00075764|OG001|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
10822319|NCT00075764|OG000|Outcome|Arm I Anastrozole|Patients receive oral anastrozole once daily on days 1-28
10822320|NCT00075764|OG001|Outcome|Arm II Anastrozole and Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
10822321|NCT00075764|EG000|Reported Event|Anastrozole|Patients receive oral anastrozole once daily on days 1-28
10822322|NCT00075764|EG001|Reported Event|Anastrozole & Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
10822323|NCT00075803|BG000|Baseline|Fluconazole|fluconazole prophylaxis
10822324|NCT00075803|BG001|Baseline|Voriconazole|voriconazole prophylaxis
10822325|NCT00075803|BG002|Baseline|Total|Total of all reporting groups
10822326|NCT00075803|FG000|Participant Flow|Fluconazole|fluconazole prophylaxis
10822327|NCT00075803|FG001|Participant Flow|Voriconazole|voriconazole prophylaxis
10822328|NCT00075803|OG000|Outcome|Fluconazole|fluconazole prophylaxis
10822329|NCT00075803|OG001|Outcome|Voriconazole|voriconazole prophylaxis
10822330|NCT00075803|EG000|Reported Event|Fluconazole|fluconazole prophylaxis
10822331|NCT00075803|EG001|Reported Event|Voriconazole|voriconazole prophylaxis
10822332|NCT00075816|BG000|Baseline|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
10822333|NCT00075816|BG001|Baseline|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
10822334|NCT00075816|BG002|Baseline|Total|Total of all reporting groups
10822335|NCT00075816|FG000|Participant Flow|Bone Marrow|Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
10822336|NCT00075816|FG001|Participant Flow|Peripheral-Blood Stem Cells|Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
10822337|NCT00075816|OG000|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
11312021|NCT03041311|EG001|Reported Event|Placebo+Etoposide/Carboplatin/Atezolizumab|"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator."
11312022|NCT03020914|BG000|Baseline|Audiovisual Distraction|"Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.~Audiovisual Distraction: watching a movie using video glasses and headphones"
11312023|NCT03020914|BG001|Baseline|Standard of Care Sedation|Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
11312024|NCT03020914|BG002|Baseline|Total|Total of all reporting groups
11312025|NCT03020914|FG000|Participant Flow|Audiovisual Distraction|"Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.~Audiovisual Distraction: watching a movie using video glasses and headphones"
11312026|NCT03020914|FG001|Participant Flow|Standard of Care Sedation|Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
11312027|NCT03020914|OG000|Outcome|Audiovisual Distraction|"Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.~Audiovisual Distraction: watching a movie using video glasses and headphones"
11312028|NCT03020914|OG001|Outcome|Standard of Care Sedation|Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
11312029|NCT03020914|EG000|Reported Event|Audiovisual Distraction|"Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.~Audiovisual Distraction: watching a movie using video glasses and headphones"
11312030|NCT03020914|EG001|Reported Event|Standard of Care Sedation|Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
11312031|NCT02803307|BG000|Baseline|6 mg TLC599|"6 mg DSP with 50 μmol PL~TLC599: Single dose via intra-articular injection"
11312032|NCT02803307|BG001|Baseline|12 mg TLC599|"12 mg DSP with 100 μmol PL~TLC599: Single dose via intra-articular injection"
11312033|NCT02803307|BG002|Baseline|Total|Total of all reporting groups
11312034|NCT02803307|FG000|Participant Flow|6 mg TLC599|"6 mg DSP with 50 μmol PL~TLC599: Single dose via intra-articular injection"
11312035|NCT02803307|FG001|Participant Flow|12 mg TLC599|"12 mg DSP with 100 μmol PL~TLC599: Single dose via intra-articular injection"
11312036|NCT02803307|OG000|Outcome|6 mg TLC599|"6 mg DSP with 50 μmol PL~TLC599: Single dose via intra-articular injection"
11312037|NCT02803307|OG001|Outcome|12 mg TLC599|"12 mg DSP with 100 μmol PL~TLC599: Single dose via intra-articular injection"
11312038|NCT02803307|EG000|Reported Event|6 mg TLC599|"6 mg DSP with 50 μmol PL~TLC599: Single dose via intra-articular injection"
11312039|NCT02803307|EG001|Reported Event|12 mg TLC599|"12 mg DSP with 100 μmol PL~TLC599: Single dose via intra-articular injection"
11312040|NCT02698891|BG000|Baseline|Paclitaxel|"After the screening procedures confirm participation in the research study:~175 mg/m^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks)~-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if:~The patient experiences a prior episode of fever and neutropenia.~If the patient has an active infection this decision will be at provider discretion.~If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles.~Paclitaxel~Neulasta"
11312041|NCT02698891|FG000|Participant Flow|Paclitaxel|"After the screening procedures confirm participation in the research study:~175 mg/m^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks)~-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if:~The patient experiences a prior episode of fever and neutropenia.~If the patient has an active infection this decision will be at provider discretion.~If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles.~Paclitaxel~Neulasta"
11312042|NCT02698891|OG000|Outcome|Paclitaxel|"After the screening procedures confirm participation in the research study:~175 mg/m^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks)~-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if:~The patient experiences a prior episode of fever and neutropenia.~If the patient has an active infection this decision will be at provider discretion.~If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles.~Paclitaxel~Neulasta"
10822338|NCT00075816|OG001|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
10822339|NCT00075816|OG000|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
10822340|NCT00075816|OG001|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
10822341|NCT00075816|EG000|Reported Event|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
10822342|NCT00075816|EG001|Reported Event|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
10822343|NCT00075829|BG000|Baseline|Auto-Auto Standard Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
10822344|NCT00075829|BG001|Baseline|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
10822345|NCT00075829|BG002|Baseline|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
10822346|NCT00075829|BG003|Baseline|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
10822347|NCT00075829|BG004|Baseline|Total|Total of all reporting groups
10822348|NCT00075829|FG000|Participant Flow|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
10822349|NCT00075829|FG001|Participant Flow|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
10822350|NCT00075829|FG002|Participant Flow|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
10822351|NCT00075829|FG003|Participant Flow|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
10822352|NCT00075829|OG000|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
10822353|NCT00075829|OG001|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
10822354|NCT00075829|OG002|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
10822355|NCT00075829|OG003|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
10822356|NCT00075829|OG000|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
10822357|NCT00075829|OG001|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
10822358|NCT00075829|OG000|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
10822359|NCT00075829|EG000|Reported Event|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
10822360|NCT00075829|EG001|Reported Event|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
10822361|NCT00075829|EG002|Reported Event|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
10822362|NCT00075829|EG003|Reported Event|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
10822363|NCT00075881|BG000|Baseline|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
10822364|NCT00075881|FG000|Participant Flow|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
10822365|NCT00075881|OG000|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
10822366|NCT00075881|OG000|Outcome|PS-341|Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
10822367|NCT00075881|OG000|Outcome|PS-341|Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose
10822368|NCT00075881|EG000|Reported Event|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
10822369|NCT00076011|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10822370|NCT00076011|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10822371|NCT00076011|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10822372|NCT00076011|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10822373|NCT00076024|BG000|Baseline|Axitinib + Docetaxel (Phase 1, Lead-in)|Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
10822374|NCT00076024|BG001|Baseline|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
10822375|NCT00076024|BG002|Baseline|Docetaxel + Placebo (Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
10822376|NCT00076024|BG003|Baseline|Total|Total of all reporting groups
10822377|NCT00076024|FG000|Participant Flow|Axitinib + Docetaxel (Phase-1, Lead-in)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
10822378|NCT00076024|FG001|Participant Flow|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
10822379|NCT00076024|FG002|Participant Flow|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
10822380|NCT00076024|FG003|Participant Flow|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
10822381|NCT00076024|OG000|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
10822382|NCT00076024|OG001|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
10822383|NCT00076024|OG000|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
10822384|NCT00076024|EG000|Reported Event|Axitinib + Docetaxel (Phase-1 Lead-in)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
10822385|NCT00076024|EG001|Reported Event|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
10822386|NCT00076024|EG002|Reported Event|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
10822387|NCT00076024|EG003|Reported Event|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
10822388|NCT00076050|BG000|Baseline|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
10822389|NCT00076050|BG001|Baseline|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
10822390|NCT00076050|BG002|Baseline|Total|Total of all reporting groups
10822391|NCT00076050|FG000|Participant Flow|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
10822392|NCT00076050|FG001|Participant Flow|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
10822393|NCT00076050|OG000|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
10822394|NCT00076050|OG001|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
10822395|NCT00076050|EG000|Reported Event|Soy Isoflavones|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
10822396|NCT00076050|EG001|Reported Event|Placebo|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
10822397|NCT00076102|BG000|Baseline|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
10822398|NCT00076102|FG000|Participant Flow|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
10822399|NCT00076102|OG000|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
10822400|NCT00076102|OG000|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
10822401|NCT00076102|OG000|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m^2/day).
10822402|NCT00076102|EG000|Reported Event|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
10822403|NCT00076219|BG000|Baseline|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
10822404|NCT00076219|BG001|Baseline|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
10822405|NCT00076219|BG002|Baseline|Total|Total of all reporting groups
10822406|NCT00076219|FG000|Participant Flow|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
10822407|NCT00076219|FG001|Participant Flow|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
10822408|NCT00076219|OG000|Outcome|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
10822409|NCT00076219|OG001|Outcome|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
10822410|NCT00076219|EG000|Reported Event|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
10822411|NCT00076219|EG001|Reported Event|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
10822412|NCT00076245|BG000|Baseline|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
10822413|NCT00076245|BG001|Baseline|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
10822414|NCT00076245|BG002|Baseline|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
10822415|NCT00076245|BG003|Baseline|4 Control|
10822416|NCT00076245|BG004|Baseline|Total|Total of all reporting groups
10822417|NCT00076245|FG000|Participant Flow|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
10822418|NCT00076245|FG001|Participant Flow|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
10822419|NCT00076245|FG002|Participant Flow|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
10822420|NCT00076245|FG003|Participant Flow|4 Control|
10822421|NCT00076245|OG000|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
10822422|NCT00076245|OG001|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
10822423|NCT00076245|OG002|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
10822424|NCT00076245|OG003|Outcome|4 Control|
10822425|NCT00076245|EG000|Reported Event|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
10822426|NCT00076245|EG001|Reported Event|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
10822427|NCT00076245|EG002|Reported Event|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
11312043|NCT02698891|EG000|Reported Event|Paclitaxel|"After the screening procedures confirm participation in the research study:~175 mg/m^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks)~-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if:~The patient experiences a prior episode of fever and neutropenia.~If the patient has an active infection this decision will be at provider discretion.~If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles.~Paclitaxel~Neulasta"
11312044|NCT02537678|BG000|Baseline|Stepped Care Trauma Focused-CBT (TF-CBT)|"Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT.~Parent/Guardian-child dyads participated.~Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks"
11312045|NCT02537678|BG001|Baseline|Standard Trauma Focused-CBT (TF-CBT)|"Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT.~Parent/Guardian-child dyads participated.~Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.)."
11312046|NCT02537678|BG002|Baseline|Total|Total of all reporting groups
11312047|NCT02537678|FG000|Participant Flow|Stepped Care TF-CBT|Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided
11312048|NCT02537678|FG001|Participant Flow|Standard TF-CBT|Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
11312049|NCT02537678|OG000|Outcome|Stepped Care TF-CBT|Participants received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided
11312050|NCT02537678|OG001|Outcome|Standard TF-CBT|Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
11312051|NCT02537678|OG000|Outcome|Stepped Care TF-CBT|Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided
11312052|NCT02537678|OG001|Outcome|Standard TF-CBT|Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
11312053|NCT02537678|OG000|Outcome|Stepped Care TF-CBT|"Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT.~Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks"
11312054|NCT02537678|OG001|Outcome|Standard TF-CBT|"Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT.~Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.)."
11312055|NCT02537678|EG000|Reported Event|Stepped Care TF-CBT|Participants (parents/guardian and children) received Step One which is a parent-led therapist-assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided.
11312056|NCT02537678|EG001|Reported Event|Standard TF-CBT|Participants (parents/guardians and children) received therapist-led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
11312057|NCT02400476|BG000|Baseline|Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.~Neratinib~Loperamide"
11312058|NCT02400476|BG001|Baseline|Budesonide and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.~Neratinib~Loperamide~Budesonide: 9 mg extended release tablets once daily with or without food for 28 days"
11312059|NCT02400476|BG002|Baseline|Colestipol and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312060|NCT02400476|BG003|Baseline|Colestipol With Loperamide as Needed|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
10822428|NCT00076245|EG003|Reported Event|4 Control|
11312061|NCT02400476|BG004|Baseline|Neratinib Dose Escalation 1|"120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.~Neratinib~Loperamide"
11312062|NCT02400476|BG005|Baseline|Neratinib Dose Escalation 2|"160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.~Neratinib~Loperamide"
11312063|NCT02400476|BG006|Baseline|Total|Total of all reporting groups
11312064|NCT02400476|FG000|Participant Flow|Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.~Neratinib~Loperamide"
11312065|NCT02400476|FG001|Participant Flow|Budesonide and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.~Neratinib~Loperamide~Budesonide: 9 mg extended release tablets once daily with or without food for 28 days"
11312066|NCT02400476|FG002|Participant Flow|Colestipol and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312067|NCT02400476|FG003|Participant Flow|Colestipol With Loperamide as Needed|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312068|NCT02400476|FG004|Participant Flow|Neratinib Dose Escalation 1|"120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.~Neratinib~Loperamide"
11312069|NCT02400476|FG005|Participant Flow|Neratinib Dose Escalation 2|"160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.~Neratinib~Loperamide"
11312070|NCT02400476|OG000|Outcome|Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.~Neratinib~Loperamide"
11312071|NCT02400476|OG001|Outcome|Budesonide and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.~Neratinib~Loperamide~Budesonide: 9 mg extended release tablets once daily with or without food for 28 days"
11312072|NCT02400476|OG002|Outcome|Colestipol and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312073|NCT02400476|OG003|Outcome|Colestipol With Loperamide as Needed|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312074|NCT02400476|OG004|Outcome|Neratinib Dose Escalation 1|"120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.~Neratinib~Loperamide"
11312075|NCT02400476|OG005|Outcome|Neratinib Dose Escalation 2|"160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.~Neratinib~Loperamide"
11312076|NCT02400476|EG000|Reported Event|Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.~Neratinib~Loperamide"
11312077|NCT02400476|EG001|Reported Event|Budesonide and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.~Neratinib~Loperamide~Budesonide: 9 mg extended release tablets once daily with or without food for 28 days"
11312078|NCT02400476|EG002|Reported Event|Colestipol and Loperamide|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312079|NCT02400476|EG003|Reported Event|Colestipol With Loperamide as Needed|"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.~Neratinib~Loperamide~Colestipol: 2 g twice daily with or without food for one 28 day cycle"
11312080|NCT02400476|EG004|Reported Event|Neratinib Dose Escalation 1|"120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.~Neratinib~Loperamide"
11312081|NCT02400476|EG005|Reported Event|Neratinib Dose Escalation 2|"160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.~Neratinib~Loperamide"
11312082|NCT02362035|BG000|Baseline|Acalabrutinib + Pembrolizumab|"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.~Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.~The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted."
10822429|NCT00076258|BG000|Baseline|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822430|NCT00076258|BG001|Baseline|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822431|NCT00076258|BG002|Baseline|Total|Total of all reporting groups
10822432|NCT00076258|FG000|Participant Flow|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822433|NCT00076258|FG001|Participant Flow|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822434|NCT00076258|OG000|Outcome|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822435|NCT00076258|OG001|Outcome|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822436|NCT00076258|EG000|Reported Event|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822437|NCT00076258|EG001|Reported Event|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
10822438|NCT00076336|BG000|Baseline|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822439|NCT00076336|BG001|Baseline|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822440|NCT00076336|BG002|Baseline|Total|Total of all reporting groups
10822441|NCT00076336|FG000|Participant Flow|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822442|NCT00076336|FG001|Participant Flow|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822443|NCT00076336|OG000|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822444|NCT00076336|OG001|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822445|NCT00076336|EG000|Reported Event|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822446|NCT00076336|EG001|Reported Event|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
10822447|NCT00076570|BG000|Baseline|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
10822448|NCT00076570|BG001|Baseline|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
10822449|NCT00076570|BG002|Baseline|Total|Total of all reporting groups
10822450|NCT00076570|FG000|Participant Flow|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
10822451|NCT00076570|FG001|Participant Flow|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
10822452|NCT00076570|OG000|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
10822453|NCT00076570|OG001|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
10822454|NCT00076570|EG000|Reported Event|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
10822455|NCT00076570|EG001|Reported Event|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
10822456|NCT00076622|BG000|Baseline|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822457|NCT00076622|BG001|Baseline|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822458|NCT00076622|BG002|Baseline|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822459|NCT00076622|BG003|Baseline|Participant Preference to Discontinue Drug|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822460|NCT00076622|BG004|Baseline|Total|Total of all reporting groups
10822461|NCT00076622|FG000|Participant Flow|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822462|NCT00076622|FG001|Participant Flow|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822463|NCT00076622|FG002|Participant Flow|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822464|NCT00076622|FG003|Participant Flow|Participant Preference to Discontinue Drug|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822465|NCT00076622|OG000|Outcome|Randomized Arm-continue|Participants who agreed to be randomized were assigned to the continuation antidepressant
10822466|NCT00076622|OG001|Outcome|Randomized Arm-discontinue|Those who were randomized to discontinue anti depressants
10822467|NCT00076622|OG002|Outcome|Non Randomized/Preference Arm-continue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
10822468|NCT00076622|OG003|Outcome|Non-Randomized Preference-discontinue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
10822469|NCT00076622|OG000|Outcome|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822470|NCT00076622|OG001|Outcome|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication (no antidepressant medication)~No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms."
10822471|NCT00076622|OG002|Outcome|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822472|NCT00076622|OG003|Outcome|Participant Preference to Discontinue Drug|"Chose to discontinue antidepressant medication (no antidepressant medication)~No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms."
10822473|NCT00076622|EG000|Reported Event|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822474|NCT00076622|EG001|Reported Event|Randomized to Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822475|NCT00076622|EG002|Reported Event|Participation Based Upon Preference (Continue)|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822476|NCT00076622|EG003|Reported Event|Participation Based Upon Preference (Discontinue)|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
10822477|NCT00076687|BG000|Baseline|Placebo|Placebo
10822478|NCT00076687|BG001|Baseline|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
10822479|NCT00076687|BG002|Baseline|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
10822480|NCT00076687|BG003|Baseline|Total|Total of all reporting groups
10822481|NCT00076687|FG000|Participant Flow|Placebo|Placebo
10822482|NCT00076687|FG001|Participant Flow|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
10822483|NCT00076687|FG002|Participant Flow|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
10822484|NCT00076687|OG000|Outcome|Placebo|Placebo
10822485|NCT00076687|OG001|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
10822486|NCT00076687|OG002|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
10822487|NCT00076687|EG000|Reported Event|Placebo|Placebo
10822488|NCT00076687|EG001|Reported Event|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
10822489|NCT00076687|EG002|Reported Event|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
10822490|NCT00076752|BG000|Baseline|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
10822491|NCT00076752|FG000|Participant Flow|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
10822492|NCT00076752|OG000|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
10822493|NCT00076752|OG000|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
10822494|NCT00076752|EG000|Reported Event|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
10822495|NCT00076804|BG000|Baseline|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
10822496|NCT00076804|BG001|Baseline|Self Administration|Self administration of ARVs
10822497|NCT00076804|BG002|Baseline|Total|Total of all reporting groups
10822498|NCT00076804|FG000|Participant Flow|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
10822499|NCT00076804|FG001|Participant Flow|Self Administration|Self administration of ARVs
10822500|NCT00076804|OG000|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
10822501|NCT00076804|OG001|Outcome|Self Administration|Self administration of ARVs
10822502|NCT00076804|EG000|Reported Event|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
10822503|NCT00076804|EG001|Reported Event|Self Administration|Self administration of ARVs
10822504|NCT00076999|BG000|Baseline|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
10822505|NCT00076999|BG001|Baseline|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
10822506|NCT00076999|BG002|Baseline|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
10822507|NCT00076999|BG003|Baseline|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
10822508|NCT00076999|BG004|Baseline|Total|Total of all reporting groups
10822509|NCT00076999|FG000|Participant Flow|TPV OS 2-<6 Yrs|Tipranavir Oral Solution (TPV OS), ages 2-5
10822510|NCT00076999|FG001|Participant Flow|TPV OS 6-<12 Yrs|Tipranavir Oral Solution (TPV OS), ages 6-11
10822511|NCT00076999|FG002|Participant Flow|TPV OS 12-18 Yrs|Tipranavir Oral Solution (TPV OS), ages 12-18
10822512|NCT00076999|FG003|Participant Flow|TPV SEDDS 6-<12 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
10822513|NCT00076999|FG004|Participant Flow|TPV SEDDS 12-18 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
10822514|NCT00076999|OG000|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
10822515|NCT00076999|OG001|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
10822516|NCT00076999|OG002|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
10822517|NCT00076999|OG003|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
10822518|NCT00076999|OG003|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
10822519|NCT00076999|OG004|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
10822520|NCT00076999|EG000|Reported Event|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
10822521|NCT00076999|EG001|Reported Event|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
10822522|NCT00076999|EG002|Reported Event|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
10822523|NCT00076999|EG003|Reported Event|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
10822524|NCT00076999|EG004|Reported Event|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
10822525|NCT00077064|BG000|Baseline|Observation|Clinical observation
10822526|NCT00077064|BG001|Baseline|Captopril|Captopril: 50 mg t.i.d.
10822527|NCT00077064|BG002|Baseline|Total|Total of all reporting groups
10822528|NCT00077064|FG000|Participant Flow|Clinical Observation|Clinical observation
10822529|NCT00077064|FG001|Participant Flow|Captopril|Captopril: 50 mg t.i.d.
10822530|NCT00077064|OG000|Outcome|Observation|Clinical observation
10822531|NCT00077064|OG001|Outcome|Captopril|Captopril: 50 mg t.i.d.
10822532|NCT00077064|OG000|Outcome|Clinical Observation|Clinical observation
10822533|NCT00077064|EG000|Reported Event|Clinical Observation|Clinical observation
10822534|NCT00077064|EG001|Reported Event|Captopril|Captopril: 50 mg t.i.d.
10822535|NCT00077207|BG000|Baseline|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
10822536|NCT00077207|FG000|Participant Flow|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
10822537|NCT00077207|OG000|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
10822538|NCT00077207|OG000|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
10822539|NCT00077207|EG000|Reported Event|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
10822540|NCT00077376|BG000|Baseline|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
10822541|NCT00077376|FG000|Participant Flow|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
10822542|NCT00077376|OG000|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
10822543|NCT00077376|EG000|Reported Event|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
10822544|NCT00077610|BG000|Baseline|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822545|NCT00077610|BG001|Baseline|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822546|NCT00077610|BG002|Baseline|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822547|NCT00077610|BG003|Baseline|Total|Total of all reporting groups
10822548|NCT00077610|FG000|Participant Flow|RO0503821 (1x/2 Weeks)|Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
10822549|NCT00077610|FG001|Participant Flow|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822550|NCT00077610|FG002|Participant Flow|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822551|NCT00077610|OG000|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
10822552|NCT00077610|OG001|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822553|NCT00077610|OG002|Outcome|Epoetin (1-3x/Week)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822554|NCT00077610|OG000|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822555|NCT00077610|OG002|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822556|NCT00077610|OG002|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
10822557|NCT00077610|OG000|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822558|NCT00077610|OG001|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
10822559|NCT00077610|EG000|Reported Event|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822560|NCT00077610|EG001|Reported Event|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
10822561|NCT00077610|EG002|Reported Event|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822562|NCT00077623|BG000|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
10822563|NCT00077623|BG001|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
10822564|NCT00077623|BG002|Baseline|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822565|NCT00077623|BG003|Baseline|Total|Total of all reporting groups
10822566|NCT00077623|FG000|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
10822567|NCT00077623|FG001|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
10822568|NCT00077623|FG002|Participant Flow|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822569|NCT00077623|OG000|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
10822570|NCT00077623|OG001|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
10822571|NCT00077623|OG002|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822572|NCT00077623|EG000|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
10822573|NCT00077623|EG001|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
10822574|NCT00077623|EG002|Reported Event|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
10822575|NCT00077636|BG000|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
10822576|NCT00077636|BG001|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
10822577|NCT00077636|BG002|Baseline|Total|Total of all reporting groups
10822578|NCT00077636|FG000|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
10822579|NCT00077636|FG001|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
10822580|NCT00077636|OG000|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
10822581|NCT00077636|OG001|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
10822582|NCT00077636|OG000|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 16 weeks.
10822583|NCT00077636|EG000|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
10822584|NCT00077636|EG001|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
10822585|NCT00077649|BG000|Baseline|PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
10822586|NCT00077649|BG001|Baseline|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822587|NCT00077649|BG002|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
10822588|NCT00077649|BG003|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822589|NCT00077649|BG004|Baseline|Total|Total of all reporting groups
10822590|NCT00077649|FG000|Participant Flow|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
10822591|NCT00077649|FG001|Participant Flow|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822592|NCT00077649|FG002|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
10822593|NCT00077649|FG003|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822594|NCT00077649|OG000|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
10822595|NCT00077649|OG001|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822596|NCT00077649|OG002|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
10822597|NCT00077649|OG003|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822598|NCT00077649|OG003|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
10822599|NCT00077649|OG001|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
10822600|NCT00077649|OG000|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
10822601|NCT00077649|OG003|Outcome|PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
10822602|NCT00077649|EG000|Reported Event|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
10822603|NCT00077649|EG001|Reported Event|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822604|NCT00077649|EG002|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
10822605|NCT00077649|EG003|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
10822606|NCT00077675|BG000|Baseline|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
10822607|NCT00077675|BG001|Baseline|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
10822608|NCT00077675|BG002|Baseline|Total|Total of all reporting groups
10822609|NCT00077675|FG000|Participant Flow|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
10822610|NCT00077675|FG001|Participant Flow|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
10822611|NCT00077675|OG000|Outcome|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
10822612|NCT00077675|OG001|Outcome|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
10822613|NCT00077675|EG000|Reported Event|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
10822614|NCT00077675|EG001|Reported Event|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
10822615|NCT00077766|BG000|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
10822616|NCT00077766|BG001|Baseline|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
10822617|NCT00077766|BG002|Baseline|Total|Total of all reporting groups
10822618|NCT00077766|FG000|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV), every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 microgram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
10822619|NCT00077766|FG001|Participant Flow|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
10822620|NCT00077766|OG000|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
10822621|NCT00077766|OG001|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
10822622|NCT00077766|OG000|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
10822623|NCT00077766|EG000|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
10822624|NCT00077766|EG001|Reported Event|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
10822625|NCT00077857|BG000|Baseline|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822626|NCT00077857|BG001|Baseline|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822627|NCT00077857|BG002|Baseline|Total|Total of all reporting groups
10822628|NCT00077857|FG000|Participant Flow|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822629|NCT00077857|FG001|Participant Flow|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822630|NCT00077857|OG000|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822631|NCT00077857|OG001|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822632|NCT00077857|EG000|Reported Event|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822633|NCT00077857|EG001|Reported Event|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
10822634|NCT00077922|BG000|Baseline|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
10822635|NCT00077922|FG000|Participant Flow|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
10822636|NCT00077922|OG000|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
10822637|NCT00077922|EG000|Reported Event|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
10822638|NCT00077974|BG000|Baseline|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
10822639|NCT00077974|FG000|Participant Flow|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
10822640|NCT00077974|OG000|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
10822641|NCT00077974|EG000|Reported Event|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
10822642|NCT00078286|BG000|Baseline|Sertraline|Participants will take sertraline for 12 weeks
10822643|NCT00078286|BG001|Baseline|Placebo|Participants will take placebo for 12 weeks
10822644|NCT00078286|BG002|Baseline|Total|Total of all reporting groups
10822645|NCT00078286|FG000|Participant Flow|Sertraline|Participants will take sertraline for 12 weeks
10822646|NCT00078286|FG001|Participant Flow|Placebo|Participants will take placebo for 12 weeks
10822647|NCT00078286|OG000|Outcome|Sertraline|Participants will take sertraline for 12 weeks
10822648|NCT00078286|OG001|Outcome|Placebo|Participants will take placebo for 12 weeks
10822649|NCT00078286|EG000|Reported Event|Sertraline|Serious adverse events in Sertraline Arm
10822650|NCT00078286|EG001|Reported Event|Placebo|Serious adverse events in Placebo Arm
10822651|NCT00078312|BG000|Baseline|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
10822652|NCT00078312|FG000|Participant Flow|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
10822653|NCT00078312|OG000|Outcome|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
10822654|NCT00078312|EG000|Reported Event|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
10822655|NCT00078325|BG000|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822656|NCT00078325|BG001|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822657|NCT00078325|BG002|Baseline|Placebo|Matching placebo tablets once daily
10822658|NCT00078325|BG003|Baseline|Total|Total of all reporting groups
10822659|NCT00078325|FG000|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822660|NCT00078325|FG001|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822661|NCT00078325|FG002|Participant Flow|Placebo|Matching placebo tablets once daily
10822662|NCT00078325|OG000|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822663|NCT00078325|OG001|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822664|NCT00078325|OG002|Outcome|Placebo|Matching placebo tablets once daily
10822665|NCT00078325|EG000|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822666|NCT00078325|EG001|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822667|NCT00078325|EG002|Reported Event|Placebo|Matching placebo tablets once daily
10822668|NCT00078338|BG000|Baseline|Rebif®|Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
10822669|NCT00078338|BG001|Baseline|Copaxone®|Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
10822670|NCT00078338|BG002|Baseline|Total|Total of all reporting groups
10822671|NCT00078338|FG000|Participant Flow|Rebif®|Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
10822672|NCT00078338|FG001|Participant Flow|Copaxone®|Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
10822673|NCT00078338|OG000|Outcome|Rebif®|Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
10822674|NCT00078338|OG001|Outcome|Copaxone®|Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
10822675|NCT00078338|EG000|Reported Event|Rebif®|Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
10822676|NCT00078338|EG001|Reported Event|Copaxone®|Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
10822677|NCT00078377|BG000|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822678|NCT00078377|BG001|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822679|NCT00078377|BG002|Baseline|Placebo|Matching placebo tablets once daily in the morning
10822680|NCT00078377|BG003|Baseline|Total|Total of all reporting groups
10822681|NCT00078377|FG000|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822682|NCT00078377|FG001|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822683|NCT00078377|FG002|Participant Flow|Placebo|Matching placebo tablets once daily in the morning
10822684|NCT00078377|OG000|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822685|NCT00078377|OG001|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822686|NCT00078377|OG002|Outcome|Placebo|Matching placebo tablets once daily in the morning
10822687|NCT00078377|OG003|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
10822688|NCT00078377|EG000|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
10822689|NCT00078377|EG001|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
11312083|NCT02362035|FG000|Participant Flow|Acalabrutinib + Pembrolizumab|"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.~Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.~The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted."
11312084|NCT02362035|OG000|Outcome|Acalabrutinib + Pembrolizumab|"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.~Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.~The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted."
11312085|NCT02362035|EG000|Reported Event|Acalabrutinib + Pembrolizumab|"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.~Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.~The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted."
11312095|NCT01818986|BG000|Baseline|Arm One|"Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)~Sipuleucel-T~Stereotactic Ablative Body Radiation"
11312096|NCT01818986|FG000|Participant Flow|Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)|Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
11312097|NCT01818986|OG000|Outcome|Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)|Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
11312098|NCT01818986|EG000|Reported Event|Arm One|"Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)~Sipuleucel-T~Stereotactic Ablative Body Radiation"
11312099|NCT01507545|BG000|Baseline|MORAb-004 8.0 mg/kg + BSC|Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312100|NCT01507545|BG001|Baseline|Placebo + BSC|Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312101|NCT01507545|BG002|Baseline|Total|Total of all reporting groups
10822690|NCT00078377|EG002|Reported Event|Placebo|Matching placebo tablets once daily in the morning
10822691|NCT00078403|BG000|Baseline|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
10822692|NCT00078403|BG001|Baseline|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
10822693|NCT00078403|BG002|Baseline|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
10822694|NCT00078403|BG003|Baseline|Total|Total of all reporting groups
10822695|NCT00078403|FG000|Participant Flow|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
10822696|NCT00078403|FG001|Participant Flow|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
10822697|NCT00078403|FG002|Participant Flow|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
10822698|NCT00078403|OG000|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
10822699|NCT00078403|OG001|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
10822700|NCT00078403|OG002|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
10822701|NCT00078403|OG002|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..
10822702|NCT00078403|EG000|Reported Event|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
10822703|NCT00078403|EG001|Reported Event|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
10822704|NCT00078403|EG002|Reported Event|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
10822705|NCT00078559|BG000|Baseline|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10842479|NCT00246740|OG001|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
10822706|NCT00078559|FG000|Participant Flow|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10822707|NCT00078559|OG000|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10822708|NCT00078559|OG000|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10822709|NCT00078559|OG000|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10822710|NCT00078559|OG001|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
10822711|NCT00078559|EG000|Reported Event|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
10842480|NCT00246740|EG000|Reported Event|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
10842481|NCT00246740|EG001|Reported Event|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
10842482|NCT00246753|BG000|Baseline|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
10842483|NCT00246753|FG000|Participant Flow|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
10842484|NCT00246753|OG000|Outcome|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
10842485|NCT00246753|EG000|Reported Event|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
10842486|NCT00246805|BG000|Baseline|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842487|NCT00246805|BG001|Baseline|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842488|NCT00246805|BG002|Baseline|Total|Total of all reporting groups
10842489|NCT00246805|FG000|Participant Flow|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842490|NCT00246805|FG001|Participant Flow|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842491|NCT00246805|OG000|Outcome|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842492|NCT00246805|OG001|Outcome|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842493|NCT00246805|EG000|Reported Event|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842494|NCT00246805|EG001|Reported Event|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
10842495|NCT00247273|BG000|Baseline|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
10842496|NCT00247273|BG001|Baseline|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
10842497|NCT00247273|BG002|Baseline|Total|Total of all reporting groups
11312102|NCT01507545|FG000|Participant Flow|MORAb-004 8.0 mg/kg + BSC|Participants received MORAb-004 8 milligram per kilogram (mg/kg), infusion intravenously (IV), once weekly, in each 2-week treatment cycle along with the best supportive care (BSC) which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312103|NCT01507545|FG001|Participant Flow|Placebo + BSC|Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312104|NCT01507545|OG000|Outcome|MORAb-004 8.0 mg/kg + BSC|Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312105|NCT01507545|OG001|Outcome|Placebo + BSC|Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312106|NCT01507545|EG000|Reported Event|MORAb-004 8.0 mg/kg + BSC|Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312107|NCT01507545|EG001|Reported Event|Placebo + BSC|Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
11312108|NCT01463670|BG000|Baseline|Lenalidomide|The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
11312109|NCT01463670|FG000|Participant Flow|Lenalidomide|The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
11312110|NCT01463670|OG000|Outcome|Lenalidomide|The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
11312111|NCT01463670|EG000|Reported Event|Lenalidomide|The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.
11312112|NCT00920816|BG000|Baseline|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312113|NCT00920816|BG001|Baseline|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312114|NCT00920816|BG002|Baseline|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312115|NCT00920816|BG003|Baseline|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312116|NCT00920816|BG004|Baseline|Total|Total of all reporting groups
11312117|NCT00920816|FG000|Participant Flow|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312118|NCT00920816|FG001|Participant Flow|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312119|NCT00920816|FG002|Participant Flow|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312120|NCT00920816|FG003|Participant Flow|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312121|NCT00920816|OG000|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312122|NCT00920816|OG001|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312123|NCT00920816|OG000|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312124|NCT00920816|OG001|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312125|NCT00920816|EG000|Reported Event|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312126|NCT00920816|EG001|Reported Event|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312127|NCT00920816|EG002|Reported Event|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312128|NCT00920816|EG003|Reported Event|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
11312129|NCT00565851|BG000|Baseline|Arm I (no Surgery; Carboplatin and Paclitaxel)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312130|NCT00565851|BG001|Baseline|Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)|"Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.~Bevacizumab: Given IV~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312131|NCT00565851|BG002|Baseline|Arm III (Surgery; Carboplatin and Paclitaxel)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312132|NCT00565851|BG003|Baseline|Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312133|NCT00565851|BG004|Baseline|Arm V (no Surgery; Carboplatin and Gemcitabine)|"Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312134|NCT00565851|BG005|Baseline|Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))|"Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312135|NCT00565851|BG006|Baseline|Arm VII (Surgery; Carboplatin and Gemcitabine)|"Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312136|NCT00565851|BG007|Baseline|Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))|"Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312137|NCT00565851|BG008|Baseline|Total|Total of all reporting groups
11312138|NCT00565851|FG000|Participant Flow|Arm I (no Surgery; Carboplatin and Paclitaxel)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
11312139|NCT00565851|FG001|Participant Flow|Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)|Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
11312140|NCT00565851|FG002|Participant Flow|Arm III (Surgery; Carboplatin and Paclitaxel)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
11312141|NCT00565851|FG003|Participant Flow|Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
10822712|NCT00078715|BG000|Baseline|Overall Study|
10822713|NCT00078715|FG000|Participant Flow|Placebo Then Yohimbine|Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
10822714|NCT00078715|FG001|Participant Flow|Yohimbine Then Placebo|Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
10822715|NCT00078715|OG000|Outcome|Placebo|Participants are randomized to blindly receive placebo for 8 days.
10822716|NCT00078715|OG001|Outcome|Yohimbine|Participants are randomized to blindly receive yohimbine for 8 days.
10822717|NCT00078715|EG000|Reported Event|Placebo|
10822718|NCT00078715|EG001|Reported Event|Yohimbine|
10822719|NCT00078728|BG000|Baseline|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
10822720|NCT00078728|BG001|Baseline|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
10822721|NCT00078728|BG002|Baseline|Total|Total of all reporting groups
10822722|NCT00078728|FG000|Participant Flow|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
10822723|NCT00078728|FG001|Participant Flow|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
10822724|NCT00078728|OG000|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
10822725|NCT00078728|OG001|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.
10822726|NCT00078728|OG001|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
10822727|NCT00078728|EG000|Reported Event|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
10822728|NCT00078728|EG001|Reported Event|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
10822729|NCT00078754|BG000|Baseline|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
10822730|NCT00078754|BG001|Baseline|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
10822731|NCT00078754|BG002|Baseline|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
10822732|NCT00078754|BG003|Baseline|Total|Total of all reporting groups
10822733|NCT00078754|FG000|Participant Flow|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
10822734|NCT00078754|FG001|Participant Flow|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
10822735|NCT00078754|FG002|Participant Flow|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
10822736|NCT00078754|OG000|Outcome|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
10822737|NCT00078754|OG001|Outcome|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
10822738|NCT00078754|OG002|Outcome|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
10822739|NCT00078754|OG000|Outcome|Fluoxetine|20-60 mg po qd for up to 12 weeks.
10822740|NCT00078754|OG001|Outcome|Divalproex|Up to 3000 mg po qd for up to 12 weeks.
10822741|NCT00078754|OG002|Outcome|Placebo|Up to 8 capsules po qd for up to 12 weeks.
10822742|NCT00078754|EG000|Reported Event|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
10822743|NCT00078754|EG001|Reported Event|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
10822744|NCT00078754|EG002|Reported Event|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
10822745|NCT00078767|BG000|Baseline|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
10822746|NCT00078767|BG001|Baseline|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
10822747|NCT00078767|BG002|Baseline|Total|Total of all reporting groups
10842498|NCT00247273|FG000|Participant Flow|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
10842499|NCT00247273|FG001|Participant Flow|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
10842500|NCT00247273|OG000|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
10842501|NCT00247273|OG001|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
10822748|NCT00078767|FG000|Participant Flow|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
10822749|NCT00078767|FG001|Participant Flow|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
10822750|NCT00078767|OG000|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
10822751|NCT00078767|OG001|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
10822752|NCT00078767|EG000|Reported Event|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
10822753|NCT00078767|EG001|Reported Event|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
10822754|NCT00078819|BG000|Baseline|Placebo|Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
10822755|NCT00078819|BG001|Baseline|Etanercept|Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
10822756|NCT00078819|BG002|Baseline|Total|Total of all reporting groups
10822757|NCT00078819|FG000|Participant Flow|Placebo|"Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a > 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.~Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).~Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48."
10822758|NCT00078819|FG001|Participant Flow|Etanercept|"Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.~Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).~Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48."
10822759|NCT00078819|FG002|Participant Flow|Withdrawal/Re-treatment Period: Placebo|"At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12-weeks in the double-blind withdrawal period (weeks 37 to 48).~Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period)."
10822760|NCT00078819|FG003|Participant Flow|Withdrawal/Re-treatment Period: Etanercept|"At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48).~Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period)."
10842502|NCT00247273|EG000|Reported Event|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
10842503|NCT00247273|EG001|Reported Event|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
10842504|NCT00247377|BG000|Baseline|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
10822761|NCT00078819|OG000|Outcome|Placebo|Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a > 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
10822762|NCT00078819|OG001|Outcome|Etanercept|Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
10822763|NCT00078819|OG000|Outcome|Placebo|Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Adverse events are reported up until escape for participants who escaped to etanercept.
10822764|NCT00078819|OG001|Outcome|Etanercept|"Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).~Adverse events are reported up until escape for participants who escaped to etanercept."
10822765|NCT00078819|OG002|Outcome|Escape: Etanercept|Participants with a > 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
10822766|NCT00078819|OG000|Outcome|Etanercept|"Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a > 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.~Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).~At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48)."
10822767|NCT00078819|EG000|Reported Event|Double-blind Period: Placebo|Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
10822768|NCT00078819|EG001|Reported Event|Double-blind Period: Etanercept 0.8 mg/kg QW|Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week (QW) during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
10822769|NCT00078819|EG002|Reported Event|Double-blind Period: Escape to Etanercept 0.8 mg/kg QW|Participants with a > 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
10822770|NCT00078819|EG003|Reported Event|Open-label Period: Etanercept 0.8 mg/kg QW|Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
10822771|NCT00078819|EG004|Reported Event|Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW|Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 continued to receive open-label etanercept 0.8 mg/kg QW plus optional topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) until week 48.
10822772|NCT00078819|EG005|Reported Event|Withdrawal Period: Placebo|At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12 weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).
10822773|NCT00078819|EG006|Reported Event|Withdrawal Period: Etanercept 0.8 mg/kg QW|At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).
10822774|NCT00078819|EG007|Reported Event|Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW|Participants randomized to placebo at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.
10822775|NCT00078819|EG008|Reported Event|Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW|Participants randomized to etanercept at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.
10822776|NCT00078897|BG000|Baseline|Selenium|"Participants receive oral selenium 200 mcg once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822777|NCT00078897|BG001|Baseline|Placebo|"Participants receive oral placebo once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822778|NCT00078897|BG002|Baseline|Total|Total of all reporting groups
10822779|NCT00078897|FG000|Participant Flow|Selenium|"Participants receive oral selenium 200 mcg once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822780|NCT00078897|FG001|Participant Flow|Placebo|"Participants receive oral placebo once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822781|NCT00078897|OG000|Outcome|Selenium|"Participants receive oral selenium 200 mcg once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822782|NCT00078897|OG001|Outcome|Placebo|"Participants receive oral placebo once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822783|NCT00078897|EG000|Reported Event|Selenium|"Participants receive oral selenium 200 mcg once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822784|NCT00078897|EG001|Reported Event|Placebo|"Participants receive oral placebo once daily.~Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled."
10822785|NCT00078949|BG000|Baseline|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
10822786|NCT00078949|BG001|Baseline|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
10822787|NCT00078949|BG002|Baseline|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
10822788|NCT00078949|BG003|Baseline|Observation|Patients undergo observation only.
10822789|NCT00078949|BG004|Baseline|Total|Total of all reporting groups
10822790|NCT00078949|FG000|Participant Flow|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
10822791|NCT00078949|FG001|Participant Flow|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
10822792|NCT00078949|FG002|Participant Flow|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
10822793|NCT00078949|FG003|Participant Flow|Observation|Patients undergo observation only.
10822794|NCT00078949|OG000|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
10822795|NCT00078949|OG001|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
10822796|NCT00078949|OG000|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
10822797|NCT00078949|OG001|Outcome|Observation|Patients undergo observation only.
10822798|NCT00078949|OG002|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
10822799|NCT00078949|OG003|Outcome|Observation|Patients undergo observation only.
10822800|NCT00078949|EG000|Reported Event|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
10822801|NCT00078949|EG001|Reported Event|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
10822802|NCT00078949|EG002|Reported Event|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
10822803|NCT00078949|EG003|Reported Event|Observation|Patients undergo observation only.
10822804|NCT00079001|BG000|Baseline|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
10822805|NCT00079001|BG001|Baseline|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
10822806|NCT00079001|BG002|Baseline|Total|Total of all reporting groups
10822807|NCT00079001|FG000|Participant Flow|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
10822808|NCT00079001|FG001|Participant Flow|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
10822809|NCT00079001|OG000|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
10822810|NCT00079001|OG001|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
10822811|NCT00079001|EG000|Reported Event|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
10822812|NCT00079001|EG001|Reported Event|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
10822813|NCT00079040|BG000|Baseline|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
10822814|NCT00079040|FG000|Participant Flow|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
10822815|NCT00079040|OG000|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
10822816|NCT00079040|EG000|Reported Event|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
10822817|NCT00079183|BG000|Baseline|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
10822818|NCT00079183|FG000|Participant Flow|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
10822819|NCT00079183|OG000|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
10822820|NCT00079183|OG000|Outcome|Sirolimus|"Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.~sirolimus: Given PO~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
10822821|NCT00079183|EG000|Reported Event|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
10822822|NCT00079274|BG000|Baseline|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822823|NCT00079274|BG001|Baseline|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822824|NCT00079274|BG002|Baseline|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822825|NCT00079274|BG003|Baseline|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822826|NCT00079274|BG004|Baseline|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
11312142|NCT00565851|FG004|Participant Flow|Arm V (no Surgery; Carboplatin and Gemcitabine)|Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
10822827|NCT00079274|BG005|Baseline|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822828|NCT00079274|BG006|Baseline|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
10822829|NCT00079274|BG007|Baseline|Total|Total of all reporting groups
10822830|NCT00079274|FG000|Participant Flow|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822831|NCT00079274|FG001|Participant Flow|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822832|NCT00079274|FG002|Participant Flow|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822833|NCT00079274|FG003|Participant Flow|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822834|NCT00079274|FG004|Participant Flow|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given I~cetuximab: Given IV"
10822835|NCT00079274|FG005|Participant Flow|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822836|NCT00079274|FG006|Participant Flow|Arm G (Locally Directed Therapy)|"Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
10822837|NCT00079274|OG000|Outcome|Wild-type KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
10822838|NCT00079274|OG001|Outcome|Wild-type KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
10822839|NCT00079274|OG000|Outcome|Mutant KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm D patients.
10822840|NCT00079274|OG001|Outcome|Mutant KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm A patients.
10822841|NCT00079274|EG000|Reported Event|Arm A (Combination Chemotherapy)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822842|NCT00079274|EG001|Reported Event|Arm B (Combination Chemotherapy)|"Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822843|NCT00079274|EG002|Reported Event|Arm C (Combination Chemotherapy)|"Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10822844|NCT00079274|EG003|Reported Event|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822845|NCT00079274|EG004|Reported Event|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
11312143|NCT00565851|FG005|Participant Flow|Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)|Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
11312144|NCT00565851|FG006|Participant Flow|Arm VII (Surgery; Carboplatin and Gemcitabine)|Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
11312145|NCT00565851|FG007|Participant Flow|Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)|Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
11312146|NCT00565851|OG000|Outcome|No Cytoreductive Surgery|All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
11312147|NCT00565851|OG001|Outcome|Cytoreductive Surgery|All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
11312148|NCT00565851|OG000|Outcome|Paclitaxel and Carboplatin Chemotherapy|All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
11312149|NCT00565851|OG001|Outcome|Paclitaxel and Carboplatin Chemotherapy With Bevacizumab|All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
11312150|NCT00565851|OG000|Outcome|Arm I (no Surgery; Carboplatin and Paclitaxel)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312151|NCT00565851|OG001|Outcome|Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)|"Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.~Bevacizumab: Given IV~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312152|NCT00565851|OG002|Outcome|Arm III (Surgery; Carboplatin and Paclitaxel)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312153|NCT00565851|OG003|Outcome|Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)|"Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Docetaxel: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
11312154|NCT00565851|OG004|Outcome|Arm V (no Surgery; Carboplatin and Gemcitabine)|"Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312155|NCT00565851|OG005|Outcome|Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))|"Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312156|NCT00565851|OG006|Outcome|Arm VII (Surgery; Carboplatin and Gemcitabine)|"Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312157|NCT00565851|OG007|Outcome|Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))|"Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.~Bevacizumab: Given IV~Carboplatin: Given IV~Gemcitabine Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
11312158|NCT00565851|EG000|Reported Event|Arm I (no Surgery; Carboplatin and Paclitaxel)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
11312159|NCT00565851|EG001|Reported Event|Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)|Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
11312160|NCT00565851|EG002|Reported Event|Arm III (Surgery; Carboplatin and Paclitaxel)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
11312161|NCT00565851|EG003|Reported Event|Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)|Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
11312162|NCT00565851|EG004|Reported Event|Arm V (no Surgery; Carboplatin and Gemcitabine)|Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
10842505|NCT00247377|BG001|Baseline|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
10842506|NCT00247377|BG002|Baseline|Total|Total of all reporting groups
11312163|NCT00565851|EG005|Reported Event|Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)|Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
10822846|NCT00079274|EG005|Reported Event|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
10822847|NCT00079274|EG006|Reported Event|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists."
10822848|NCT00079326|BG000|Baseline|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10822849|NCT00079326|BG001|Baseline|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10822850|NCT00079326|BG002|Baseline|Total|Total of all reporting groups
10822851|NCT00079326|FG000|Participant Flow|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10822852|NCT00079326|FG001|Participant Flow|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10822853|NCT00079326|OG000|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10822854|NCT00079326|OG001|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
11312164|NCT00565851|EG006|Reported Event|Arm VII (Surgery; Carboplatin and Gemcitabine)|Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
10822855|NCT00079326|EG000|Reported Event|All Study Participants|All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
10822856|NCT00079339|BG000|Baseline|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10822857|NCT00079339|BG001|Baseline|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
10822858|NCT00079339|BG002|Baseline|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10822859|NCT00079339|BG003|Baseline|Total|Total of all reporting groups
10822860|NCT00079339|FG000|Participant Flow|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10842507|NCT00247377|FG000|Participant Flow|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
10842508|NCT00247377|FG001|Participant Flow|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
10842509|NCT00247377|OG000|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
10842510|NCT00247377|OG001|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
11312165|NCT00565851|EG007|Reported Event|Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)|Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
10822861|NCT00079339|FG001|Participant Flow|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
10822862|NCT00079339|FG002|Participant Flow|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10822863|NCT00079339|OG000|Outcome|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
10822864|NCT00079339|OG001|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
10822865|NCT00079339|OG002|Outcome|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
10822866|NCT00079339|OG000|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
10822867|NCT00079339|OG000|Outcome|Tipifarnib - Any Dose Level|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI perfusion scan.
10822868|NCT00079339|OG000|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI diffusion scan.
10822869|NCT00079339|OG000|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI scan.
10822870|NCT00079339|OG000|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
10822871|NCT00079339|EG000|Reported Event|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10822872|NCT00079339|EG001|Reported Event|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
10842511|NCT00247377|EG000|Reported Event|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
11312166|NCT03180645|BG000|Baseline|Test Product/ No Treatment|Participants randomized to this arm applied Test product at allocated side and left other side untreated.
11312167|NCT03180645|BG001|Baseline|Test Product/ Positive Control|Participants randomized to this arm applied Test and positive product at allocated sides.
11312168|NCT03180645|BG002|Baseline|Positive Control /No Treatment|Participants randomized to this arm applied Positive product at allocated side and left other side untreated.
11312169|NCT03180645|BG003|Baseline|Total|Total of all reporting groups
11312170|NCT03180645|FG000|Participant Flow|Test Product/ No Treatment|Participants randomized to this arm applied Test product at allocated side and left other side untreated.
11312171|NCT03180645|FG001|Participant Flow|Test Product/ Positive Control|Participants randomized to this arm applied Test and positive product at allocated sides.
11312172|NCT03180645|FG002|Participant Flow|Positive Control /No Treatment|Participants randomized to this arm applied Positive product at allocated side and left other side untreated.
11312173|NCT03180645|OG000|Outcome|Test Product|Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
11312174|NCT03180645|OG001|Outcome|No Treatment|Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
11312175|NCT03180645|OG000|Outcome|Positive Control|Data of this arm Included all allotted sides of the face of the participants where positive control was applied during the study.
11312176|NCT03180645|OG001|Outcome|Positive Control|Data of this arm Included all allotted sides of the face of the participants where positive control was applied during the study.
11312177|NCT03180645|OG002|Outcome|No Treatment|Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
11312178|NCT03180645|OG002|Outcome|Negative Control|Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
11312179|NCT03180645|EG000|Reported Event|Test Product|Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
10842512|NCT00247377|EG001|Reported Event|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
10842513|NCT00247416|BG000|Baseline|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
11312180|NCT03180645|EG001|Reported Event|Positive Control|Data of this arm Included all allotted sides of the face of the participants where positive control was applied during the study.
11312181|NCT03180645|EG002|Reported Event|No Treatment|Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
11312182|NCT03180645|EG003|Reported Event|Overall Participants|All randomized participants were included in the baseline assessment and received test product (moisturizing cream), positive control and no treatment.
11312183|NCT03180801|BG000|Baseline|Group 1 Adjuvanted Placebo|adjuvanted placebo on Day -43 and on Day -22 followed
11312184|NCT03180801|BG001|Baseline|Group 2 Adjuvanted FLU-v One Dose|500mcg adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
11312185|NCT03180801|BG002|Baseline|Group 3 Adjuvanted FLU-v Two Doses|500mcg adjuvanted FLU-v vaccine on Day -43 and on Day -22
11312186|NCT03180801|BG003|Baseline|Total|Total of all reporting groups
11312187|NCT03180801|FG000|Participant Flow|Group 1 Adjuvanted Placebo|0.5ml adjuvanted placebo (Montanide ISA-51: WFI) on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
11312188|NCT03180801|FG001|Participant Flow|Group 2 Adjuvanted FLU-v One Dose|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
11312189|NCT03180801|FG002|Participant Flow|Group 3 Adjuvanted FLU-v Two Doses|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
11312190|NCT03180801|OG000|Outcome|Group 1 Adjuvanted Placebo|0.5ml adjuvanted placebo on Day -43 and on Day -22
11312191|NCT03180801|OG001|Outcome|Group 2 Adjuvanted FLU-v One Dose|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
11312192|NCT03180801|OG002|Outcome|Group 3 Adjuvanted FLU-v Two Doses|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
11312193|NCT03180801|OG000|Outcome|Group 1 Adjuvanted Placebo|0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
11312194|NCT03180801|OG001|Outcome|Group 2 Adjuvanted FLU-v One Dose|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
11312195|NCT03180801|OG002|Outcome|Group 3 Adjuvanted FLU-v Two Doses|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
11312196|NCT03180801|EG000|Reported Event|Group 1 Adjuvanted Placebo|0.5ml adjuvanted placebo on Day -43 and on Day -22
11312197|NCT03180801|EG001|Reported Event|Group 2 Adjuvanted FLU-v One Dose|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
11312198|NCT03180801|EG002|Reported Event|Group 3 Adjuvanted FLU-v Two Doses|0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
11312199|NCT03181009|BG000|Baseline|Group A (300 mg Maintenance Dose)|"After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
10822873|NCT00079339|EG002|Reported Event|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
10822874|NCT00079391|BG000|Baseline|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
10822875|NCT00079391|FG000|Participant Flow|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
10822876|NCT00079391|OG000|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
10822877|NCT00079391|OG000|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|"Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. Cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant."
10822878|NCT00079391|OG000|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
10822879|NCT00079391|EG000|Reported Event|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
10822880|NCT00079417|BG000|Baseline|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
10822881|NCT00079417|FG000|Participant Flow|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or photobiomodulation is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
10822882|NCT00079417|OG000|Outcome|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or photobiomodulation is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
10822883|NCT00079417|EG000|Reported Event|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
10822884|NCT00079677|BG000|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822885|NCT00079677|BG001|Baseline|Placebo|Matching placebo tablets once daily
10822886|NCT00079677|BG002|Baseline|Total|Total of all reporting groups
10822887|NCT00079677|FG000|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
11312200|NCT03181009|BG001|Baseline|Group B (1200 Maintenance Dose)|"After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312201|NCT03181009|BG002|Baseline|Total|Total of all reporting groups
11312202|NCT03181009|FG000|Participant Flow|Group A (300 mg Maintenance Dose)|"After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312203|NCT03181009|FG001|Participant Flow|Group B (1200 Maintenance Dose)|"After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312204|NCT03181009|OG000|Outcome|Group A (300 mg Maintenance Dose)|"After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312205|NCT03181009|OG001|Outcome|Group B (1200 Maintenance Dose)|"After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312206|NCT03181009|EG000|Reported Event|Group A (300 mg Maintenance Dose)|"After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312207|NCT03181009|EG001|Reported Event|Group B (1200 Maintenance Dose)|"After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle."
11312208|NCT03181308|BG000|Baseline|8 mg/kg TRC105 Plus Nivolumab|Dose Level 1 8 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1
10822888|NCT00079677|FG001|Participant Flow|Placebo|Matching placebo tablets once daily
10822889|NCT00079677|OG000|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822890|NCT00079677|OG001|Outcome|Placebo|Matching placebo tablets once daily
10822891|NCT00079677|EG000|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
10822892|NCT00079677|EG001|Reported Event|Placebo|Matching placebo tablets once daily
10822893|NCT00079781|BG000|Baseline|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
10822894|NCT00079781|BG001|Baseline|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
10822895|NCT00079781|BG002|Baseline|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
10822896|NCT00079781|BG003|Baseline|Total|Total of all reporting groups
10822897|NCT00079781|FG000|Participant Flow|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
10822898|NCT00079781|FG001|Participant Flow|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
11312209|NCT03181308|BG001|Baseline|10 mg/kg TRC105 Plus Nivolumab|Dose Level 2 10 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1
11312210|NCT03181308|BG002|Baseline|Total|Total of all reporting groups
10822899|NCT00079781|FG002|Participant Flow|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
10822900|NCT00079781|OG000|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
10822901|NCT00079781|OG000|Outcome|Treatment Population|Open Label Group and Treatment Group combined.
10822902|NCT00079781|EG000|Reported Event|Treatment Population|Open Label Group and Treatment Group combined.
10822903|NCT00079781|EG001|Reported Event|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
10822904|NCT00079937|BG000|Baseline|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822905|NCT00079937|BG001|Baseline|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822906|NCT00079937|BG002|Baseline|Total|Total of all reporting groups
10822907|NCT00079937|FG000|Participant Flow|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822908|NCT00079937|FG001|Participant Flow|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822909|NCT00079937|OG000|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822910|NCT00079937|OG001|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
11312211|NCT03181308|FG000|Participant Flow|8 mg/kg TRC105 + Nivolumab|"Dose Level 1 8 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
10822911|NCT00079937|EG000|Reported Event|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822912|NCT00079937|EG001|Reported Event|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
10822913|NCT00080119|BG000|Baseline|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822914|NCT00080119|BG001|Baseline|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822915|NCT00080119|BG002|Baseline|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822916|NCT00080119|BG003|Baseline|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822917|NCT00080119|BG004|Baseline|Total|Total of all reporting groups
10822918|NCT00080119|FG000|Participant Flow|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822919|NCT00080119|FG001|Participant Flow|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822920|NCT00080119|FG002|Participant Flow|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822921|NCT00080119|FG003|Participant Flow|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822922|NCT00080119|OG000|Outcome|HIVpos/INH|
10822923|NCT00080119|OG001|Outcome|HIVpos/PL|
10822924|NCT00080119|OG000|Outcome|HIVneg/INH|
10822925|NCT00080119|OG001|Outcome|HIVneg/PL|
10822926|NCT00080119|OG002|Outcome|HIVpos/INH|
10822927|NCT00080119|OG003|Outcome|HIVpos/PL|
10822928|NCT00080119|EG000|Reported Event|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822929|NCT00080119|EG001|Reported Event|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
10822930|NCT00080119|EG002|Reported Event|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822931|NCT00080119|EG003|Reported Event|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
10822932|NCT00080223|BG000|Baseline|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
10822933|NCT00080223|FG000|Participant Flow|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
10822934|NCT00080223|OG000|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
11312212|NCT03181308|FG001|Participant Flow|10 mg/kg TRC105 + Nivolumab|"Dose Level 2 10 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
11312213|NCT03181308|OG000|Outcome|8 mg/kg TRC105 + Nivolumab|"Dose Level 1 8 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
11312214|NCT03181308|OG001|Outcome|10 mg/kg TRC105 + Nivolumab|"Dose Level 2 10 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
11312215|NCT03181308|EG000|Reported Event|8 mg/kg TRC105 + Nivolumab|"Dose Level 1 8 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
11312216|NCT03181308|EG001|Reported Event|10 mg/kg TRC105 + Nivolumab|"Dose Level 2 10 mg/kg TRC105 + Nivolumab~Carotuximab (TRC105): Anti Endoglin Antibody~OPDIVO (Nivolumab): Programmed Death Receptor-1"
11312217|NCT03181451|BG000|Baseline|7.8 mg Ferric Maltol|"12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312218|NCT03181451|BG001|Baseline|16.6 mg Ferric Maltol|"13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312219|NCT03181451|BG002|Baseline|30 mg Ferric Maltol|"12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312220|NCT03181451|BG003|Baseline|Total|Total of all reporting groups
11312221|NCT03181451|FG000|Participant Flow|30 mg Ferric Maltol|"12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312222|NCT03181451|FG001|Participant Flow|16.6 mg Ferric Maltol|"13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312223|NCT03181451|FG002|Participant Flow|7.8 mg Ferric Maltol|"12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312224|NCT03181451|OG000|Outcome|30 mg Ferric Maltol|"12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312225|NCT03181451|OG001|Outcome|16.6 mg Ferric Maltol|"13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312226|NCT03181451|OG002|Outcome|7.8 mg Ferric Maltol|"12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312227|NCT03181451|OG000|Outcome|7.8 mg Ferric Maltol|"12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312228|NCT03181451|OG002|Outcome|30 mg Ferric Maltol|"12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312229|NCT03181451|EG000|Reported Event|30 mg Ferric Maltol|"12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312230|NCT03181451|EG001|Reported Event|16.6 mg Ferric Maltol|"13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
11312231|NCT03181451|EG002|Reported Event|7.8 mg Ferric Maltol|"12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 & Day 10.~Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide."
10822935|NCT00080223|EG000|Reported Event|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
10822936|NCT00080288|BG000|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
10822937|NCT00080288|BG001|Baseline|Placebo|Matching placebo tablets once daily
10822938|NCT00080288|BG002|Baseline|Total|Total of all reporting groups
10822939|NCT00080288|FG000|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
10822940|NCT00080288|FG001|Participant Flow|Placebo|Matching placebo tablets once daily
10822941|NCT00080288|OG000|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
11312232|NCT03181503|BG000|Baseline|Placebo|Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312233|NCT03181503|BG001|Baseline|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312234|NCT03181503|BG002|Baseline|Total|Total of all reporting groups
11312235|NCT03181503|FG000|Participant Flow|Placebo|Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
10822942|NCT00080288|OG001|Outcome|Placebo|Matching placebo tablets once daily
10822943|NCT00080288|EG000|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
10822944|NCT00080288|EG001|Reported Event|Placebo|Matching placebo tablets once daily
10822945|NCT00080301|BG000|Baseline|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
10822946|NCT00080301|BG001|Baseline|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
10822947|NCT00080301|BG002|Baseline|Total|Total of all reporting groups
10822948|NCT00080301|FG000|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
10822949|NCT00080301|FG001|Participant Flow|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
10822950|NCT00080301|OG000|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
10822951|NCT00080301|OG001|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
10822952|NCT00080301|OG000|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10822953|NCT00080301|EG000|Reported Event|Capecitabine|
10822954|NCT00080301|EG001|Reported Event|Ixabepilone + Capecitabine|
10822955|NCT00080470|BG000|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10822956|NCT00080470|BG001|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10822957|NCT00080470|BG002|Baseline|Total|Total of all reporting groups
10822958|NCT00080470|FG000|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
10822959|NCT00080470|FG001|Participant Flow|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10822960|NCT00080470|OG000|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
10822961|NCT00080470|OG001|Outcome|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10822962|NCT00080470|OG000|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10822963|NCT00080470|OG001|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10822964|NCT00080470|EG000|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10822965|NCT00080470|EG001|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10822966|NCT00080483|BG000|Baseline|1Testosterone Only|Testosterone transdermally 5 g a day
10822967|NCT00080483|BG001|Baseline|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
10822968|NCT00080483|BG002|Baseline|Total|Total of all reporting groups
11312236|NCT03181503|FG001|Participant Flow|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of 0.5 milligram per kilogram (mg/kg) of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312237|NCT03181503|OG000|Outcome|Placebo|Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11217679|NCT02315560|FG000|Participant Flow|Tibial Nerve Stimulation|"The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit~TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children"
11217680|NCT02315560|OG000|Outcome|Foot Stimulation|"The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit~TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children"
11217681|NCT02315560|EG000|Reported Event|Foot Stimulation|"The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit~TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children"
11217682|NCT02315625|BG000|Baseline|Sunitinib Followed by Everolimus|In Period 1 participants received Sunitinib 37.5 mg once daily until progression or unacceptable treatment-related toxicity. In Period 2 participants received Everolimus 10 mg daily until progression or unacceptable treatment-related toxicity.
11217683|NCT02315625|BG001|Baseline|Everolimus Followed by Sunitinib|In Period 1 participants received Everolimus 10 mg daily until progression or unacceptable treatment-related toxicity. In Period 2 participants received Sunitinib 37.5 mg once daily until progression or unacceptable treatment-related toxicity.
11217684|NCT02315625|BG002|Baseline|Total|Total of all reporting groups
11217685|NCT02315625|FG000|Participant Flow|Sunitinib Followed by Everolimus|In Period 1 participants received Sunitinib 37.5 mg once daily until progression or unacceptable treatment-related toxicity. In Period 2 participants received Everolimus 10 mg daily until progression or unacceptable treatment-related toxicity.
11217686|NCT02315625|FG001|Participant Flow|Everolimus Followed by Sunitinib|In Period 1 participants received Everolimus 10 mg daily until progression or unacceptable treatment-related toxicity. In Period 2 participants received Sunitinib 37.5 mg once daily until progression or unacceptable treatment-related toxicity.
11217687|NCT02315625|OG000|Outcome|Sunitinib First, Everolimus Second|Participants who received Sunitinib first, followed by Everolimus.
11217688|NCT02315625|OG001|Outcome|Everolimus First, Sunitinib Second|Participants who received Everolimus first, followed by Sunitinib.
11217689|NCT02315625|OG000|Outcome|Sunitinib|Participants who received Sunitinib in period 1 or 2.
11217690|NCT02315625|OG001|Outcome|Everolimus|Participants who received Everolimus in period 1 or 2.
11217691|NCT02315625|EG000|Reported Event|Sunitinib|Participants who received Sunitinib in period 1 or 2.
11217692|NCT02315625|EG001|Reported Event|Everolimus|Participants who received Everolimus in period 1 or 2.
11217693|NCT02315664|BG000|Baseline|Immediate Intervention Group|Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.
11217694|NCT02315664|BG001|Baseline|Delayed Intervention Group|Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.
11217695|NCT02315664|BG002|Baseline|Total|Total of all reporting groups
11217696|NCT02315664|FG000|Participant Flow|Immediate Intervention Group|"Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.~Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately."
11217697|NCT02315664|FG001|Participant Flow|Delayed Intervention Group|"Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.~Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay."
10822969|NCT00080483|FG000|Participant Flow|1Testosterone Only|Testosterone transdermally 5 g a day
10822970|NCT00080483|FG001|Participant Flow|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
10822971|NCT00080483|OG000|Outcome|1 The Effects of Testosterone Combined With G|"AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day~AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years"
10822972|NCT00080483|OG001|Outcome|2 The Effects of Testosterone Alone on Structural and Mechanic|"AndroGel transdermally 5 g a day for two years~testosterone: AndroGel transdermally 5 g a day for two years"
10822973|NCT00080483|EG000|Reported Event|1Testosterone Only|Testosterone transdermally 5 g a day
10822974|NCT00080483|EG001|Reported Event|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
10822975|NCT00080535|BG000|Baseline|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
10822976|NCT00080535|FG000|Participant Flow|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
10822977|NCT00080535|OG000|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
10822978|NCT00080535|EG000|Reported Event|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
10822979|NCT00080899|BG000|Baseline|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
10822980|NCT00080899|FG000|Participant Flow|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
10822981|NCT00080899|OG000|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
10822982|NCT00080899|EG000|Reported Event|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
10822983|NCT00080912|BG000|Baseline|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
10822984|NCT00080912|BG001|Baseline|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
10822985|NCT00080912|BG002|Baseline|Total|Total of all reporting groups
10822986|NCT00080912|FG000|Participant Flow|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
10822987|NCT00080912|FG001|Participant Flow|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
10822988|NCT00080912|OG000|Outcome|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
10822989|NCT00080912|OG001|Outcome|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
10822990|NCT00080912|EG000|Reported Event|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
10822991|NCT00080912|EG001|Reported Event|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
10822992|NCT00080938|BG000|Baseline|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
10822993|NCT00080938|FG000|Participant Flow|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
10822994|NCT00080938|OG000|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
11312238|NCT03181503|OG001|Outcome|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
10822995|NCT00080938|EG000|Reported Event|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
10822996|NCT00081159|BG000|Baseline|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
10822997|NCT00081159|BG001|Baseline|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
10822998|NCT00081159|BG002|Baseline|Total|Total of all reporting groups
10822999|NCT00081159|FG000|Participant Flow|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
10823000|NCT00081159|FG001|Participant Flow|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
10823001|NCT00081159|OG000|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
10823002|NCT00081159|OG001|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
10823003|NCT00081159|EG000|Reported Event|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
10823004|NCT00081159|EG001|Reported Event|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
10823005|NCT00081263|BG000|Baseline|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
10823006|NCT00081263|BG001|Baseline|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
10823007|NCT00081263|BG002|Baseline|Total|Total of all reporting groups
10823008|NCT00081263|FG000|Participant Flow|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
10823009|NCT00081263|FG001|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
10823010|NCT00081263|OG000|Outcome|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
10823011|NCT00081263|OG001|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
10823012|NCT00081263|EG000|Reported Event|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
10823013|NCT00081263|EG001|Reported Event|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
10823014|NCT00081289|BG000|Baseline|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823015|NCT00081289|BG001|Baseline|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823016|NCT00081289|BG002|Baseline|Total|Total of all reporting groups
10823017|NCT00081289|FG000|Participant Flow|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823018|NCT00081289|FG001|Participant Flow|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
11312239|NCT03181503|OG000|Outcome|Placebo|Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312240|NCT03181503|OG001|Outcome|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of 0.5 milligram per kilogram (mg/kg) of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312241|NCT03181503|OG001|Outcome|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of 0.5 mg/kg of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
11312242|NCT03181503|EG000|Reported Event|Placebo|Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
11312243|NCT03181503|EG001|Reported Event|Nemolizumab 0.5 mg/kg|Participants received 3 subcutaneous injections of nemolizumab 0.5 mg/kg Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
11312244|NCT03181594|BG000|Baseline|Treatment With the ClariFix Device|"Bilateral ablation of nasal tissue for treatment of chronic rhinitis~ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device"
11312245|NCT03181594|FG000|Participant Flow|Treatment With the ClariFix Device|"Bilateral ablation of nasal tissue for treatment of chronic rhinitis~ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device"
11312246|NCT03181594|OG000|Outcome|Treatment With the ClariFix Device|"Bilateral ablation of nasal tissue for treatment of chronic rhinitis~ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device"
11312247|NCT03181594|EG000|Reported Event|Treatment With the ClariFix Device|"Bilateral ablation of nasal tissue for treatment of chronic rhinitis~ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device"
11312248|NCT03181724|BG000|Baseline|Decision Aid|"Cohort that will receive a decision aid.~Decision Aid: Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
11312249|NCT03181724|BG001|Baseline|No Decision Aid (Control)|One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
11312250|NCT03181724|BG002|Baseline|Total|Total of all reporting groups
11312251|NCT03181724|FG000|Participant Flow|Decision Aid|"Cohort that will receive a decision aid.~Decision Aid: Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
11312252|NCT03181724|FG001|Participant Flow|No Decision Aid (Control)|One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
11312253|NCT03181724|OG000|Outcome|Decision Aid|"Cohort that will receive a decision aid.~Decision Aid: Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
11312254|NCT03181724|OG001|Outcome|No Decision Aid (Control)|One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
11312255|NCT03181724|EG000|Reported Event|Decision Aid|"Cohort that will receive a decision aid.~Decision Aid: Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
11312256|NCT03181724|EG001|Reported Event|No Decision Aid (Control)|One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
10823019|NCT00081289|OG000|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
11312257|NCT03181932|BG000|Baseline|Double-blind Vancomycin Inhalation Powder|"Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Vancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
10823020|NCT00081289|OG001|Outcome|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823021|NCT00081289|OG000|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823022|NCT00081289|EG000|Reported Event|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823023|NCT00081289|EG001|Reported Event|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
10823024|NCT00081328|BG000|Baseline|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
10823025|NCT00081328|BG001|Baseline|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
10823026|NCT00081328|BG002|Baseline|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
10823027|NCT00081328|BG003|Baseline|Total|Total of all reporting groups
10823028|NCT00081328|FG000|Participant Flow|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets"
10823029|NCT00081328|FG001|Participant Flow|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets"
10823030|NCT00081328|FG002|Participant Flow|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
10823031|NCT00081328|OG000|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
10823032|NCT00081328|OG001|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
10823033|NCT00081328|OG002|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
10823034|NCT00081328|OG001|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
10823035|NCT00081328|EG000|Reported Event|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
10823036|NCT00081328|EG001|Reported Event|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
10823037|NCT00081328|EG002|Reported Event|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
10823038|NCT00081458|BG000|Baseline|Placebo|Placebo injected subcutaneously daily
10823039|NCT00081458|BG001|Baseline|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
10823040|NCT00081458|BG002|Baseline|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
10823041|NCT00081458|BG003|Baseline|Total|Total of all reporting groups
10823042|NCT00081458|FG000|Participant Flow|Placebo|Placebo injected subcutaneously daily
10823043|NCT00081458|FG001|Participant Flow|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
10823044|NCT00081458|FG002|Participant Flow|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
10823045|NCT00081458|OG000|Outcome|Placebo|Placebo injectable subcutaneously daily into the thigh or abdomen
10823046|NCT00081458|OG001|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
10823047|NCT00081458|OG002|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
10823048|NCT00081458|OG000|Outcome|Placebo|Placebo injected subcutaneously daily into the thigh or abdomen
10823049|NCT00081458|EG000|Reported Event|Placebo|Placebo injected subcutaneously daily
10823050|NCT00081458|EG001|Reported Event|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
10823051|NCT00081458|EG002|Reported Event|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
10823052|NCT00081497|BG000|Baseline|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
10823053|NCT00081497|BG001|Baseline|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
10823054|NCT00081497|BG002|Baseline|Total|Total of all reporting groups
11312258|NCT03181932|BG001|Baseline|Double-blind Placebo Inhalation Powder|"Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Placebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
11312259|NCT03181932|BG002|Baseline|Total|Total of all reporting groups
11312260|NCT03181932|FG000|Participant Flow|Double-blind Vancomycin Inhalation Powder|"Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Vancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
11312261|NCT03181932|FG001|Participant Flow|Double-blind Placebo Inhalation Powder|"Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Placebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
11312262|NCT03181932|OG000|Outcome|Double-blind Vancomycin Inhalation Powder|"Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Vancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
11312263|NCT03181932|OG001|Outcome|Double-blind Placebo Inhalation Powder|"Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Placebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1."
11312264|NCT03181932|EG000|Reported Event|Double-blind Vancomycin Inhalation Powder|"Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Vancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 participants ≤21 years old, 25 participants >21 years old) for 24 weeks during Period 1."
11312265|NCT03181932|EG001|Reported Event|Double-blind Placebo Inhalation Powder|"Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Placebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 participants ≤21 years old, 25 participants >21 years old) for 24 weeks during Period 1."
11312266|NCT03181932|EG002|Reported Event|Open-label Vancomycin Inhalation Powder|"In the 24-week Period 2, all participants receive vancomycin inhalation powder 30 mg BID by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.~Vancomycin inhalation powder: In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder."
11312267|NCT03181958|BG000|Baseline|NHFOV|"neonates assigned to NHFOV will be started with the following boundaries:~a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.~NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation."
11312268|NCT03181958|BG001|Baseline|NCPAP|"Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.~NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation."
11312269|NCT03181958|BG002|Baseline|NIPPV|"neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).~NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."
11312270|NCT03181958|BG003|Baseline|Total|Total of all reporting groups
11312271|NCT03181958|FG000|Participant Flow|NHFOV|"neonates assigned to NHFOV will be started with the following boundaries:~a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.~NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation."
10823055|NCT00081497|FG000|Participant Flow|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
10823056|NCT00081497|FG001|Participant Flow|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
11312272|NCT03181958|FG001|Participant Flow|NCPAP|"Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.~NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation."
11312273|NCT03181958|FG002|Participant Flow|NIPPV|"neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).~NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."
11312274|NCT03181958|OG000|Outcome|NHFOV|"neonates assigned to NHFOV will be started with the following boundaries:~a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.~NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation."
11312275|NCT03181958|OG001|Outcome|NCPAP|"Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.~NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation."
11312276|NCT03181958|OG002|Outcome|NIPPV|"neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).~NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."
11312277|NCT03181958|EG000|Reported Event|NHFOV|"neonates assigned to NHFOV will be started with the following boundaries:~a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.~NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation."
11312278|NCT03181958|EG001|Reported Event|NCPAP|"Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.~NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation."
11312279|NCT03181958|EG002|Reported Event|NIPPV|"neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).~NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."
11312280|NCT03182582|BG000|Baseline|Laser and Sharp Debridement|"Laser debridement will be performed at 200-um until punctate bleeding is visualized. Sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
10823057|NCT00081497|OG000|Outcome|Placebo Period - AGAL-008-00 (NCT00074984)|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).
10823058|NCT00081497|OG001|Outcome|Fabrazyme Period - AGAL02503 (NCT00081497)|Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.
10823059|NCT00081497|OG000|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR >60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
10823060|NCT00081497|OG001|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR >60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
10823061|NCT00081497|OG002|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
10823062|NCT00081497|OG003|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
10823063|NCT00081497|OG000|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
10823064|NCT00081497|EG000|Reported Event|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
10823065|NCT00081497|EG001|Reported Event|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
10823066|NCT00081497|EG002|Reported Event|Total|
10823067|NCT00081653|BG000|Baseline|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
10823068|NCT00081653|BG001|Baseline|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
10823069|NCT00081653|BG002|Baseline|Total|Total of all reporting groups
10823070|NCT00081653|FG000|Participant Flow|Ibandronate 100 Milligrams (mg)|100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
10823071|NCT00081653|FG001|Participant Flow|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
10823072|NCT00081653|OG000|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
10823073|NCT00081653|OG001|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
10823074|NCT00081653|OG000|Outcome|Ibandronate 100 mg|100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
10823075|NCT00081653|EG000|Reported Event|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
10823076|NCT00081653|EG001|Reported Event|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
10823077|NCT00081731|BG000|Baseline|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
10823078|NCT00081731|BG001|Baseline|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
10823079|NCT00081731|BG002|Baseline|Total|Total of all reporting groups
10823080|NCT00081731|FG000|Participant Flow|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
10823081|NCT00081731|FG001|Participant Flow|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
10823082|NCT00081731|OG000|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
10823083|NCT00081731|OG001|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
10823084|NCT00081731|EG000|Reported Event|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
10823085|NCT00081731|EG001|Reported Event|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
10823086|NCT00081770|BG000|Baseline|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823087|NCT00081770|BG001|Baseline|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823088|NCT00081770|BG002|Baseline|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823089|NCT00081770|BG003|Baseline|Total|Total of all reporting groups
10823090|NCT00081770|FG000|Participant Flow|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823091|NCT00081770|FG001|Participant Flow|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823092|NCT00081770|FG002|Participant Flow|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823093|NCT00081770|OG000|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823094|NCT00081770|OG001|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823095|NCT00081770|OG002|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
10823096|NCT00081770|EG000|Reported Event|PegIntron 1.5 ug/kg/wk Plus REBETOL|
10823097|NCT00081770|EG001|Reported Event|PegIntron 1.0 ug/kg/wk Plus REBETOL|
10823098|NCT00081770|EG002|Reported Event|PEGASYS 180 ug/wk Plus COPEGUS|
10823099|NCT00081861|BG000|Baseline|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10823100|NCT00081861|FG000|Participant Flow|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10823101|NCT00081861|OG000|Outcome|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10823102|NCT00081861|EG000|Reported Event|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10823103|NCT00081939|BG000|Baseline|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
10823104|NCT00081939|FG000|Participant Flow|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
10823105|NCT00081939|OG000|Outcome|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
10823106|NCT00081939|EG000|Reported Event|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
10823107|NCT00082017|BG000|Baseline|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
10823108|NCT00082017|FG000|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days."
10823109|NCT00082017|FG001|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|"Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
11312281|NCT03182582|FG000|Participant Flow|Laser, Then Sharp|"During the first treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized. During the second treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
11312282|NCT03182582|FG001|Participant Flow|Sharp, Then Laser|"During the first treatment, sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized. During the second treatment, laser debridement will be performed at 200-um until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
11312283|NCT03182582|OG000|Outcome|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
11312284|NCT03182582|OG001|Outcome|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
11312285|NCT03182582|OG000|Outcome|Pre-Laser Debridement|A tissue biopsy was performed prior to laser debridement. This tissue was analyzed for bacterial load.
11312286|NCT03182582|OG001|Outcome|Post-Laser Debridement|A tissue biopsy was performed after laser debridement. This tissue was analyzed for bacterial load.
11312287|NCT03182582|OG000|Outcome|Pre-Sharp Debridement|A tissue biopsy was performed prior to curette/scalpel debridement. This tissue was analyzed for bacterial load.
11312288|NCT03182582|OG001|Outcome|Post-Sharp Debridement|A tissue biopsy was performed after curette/scalpel debridement. This tissue was analyzed for bacterial load.
11312289|NCT03182582|OG000|Outcome|Laser and Sharp Debridement|"Laser debridement will be performed at 200-um until punctate bleeding is visualized. Sharp debridement will be performed via a scalpel/curette until punctate bleeding is visualized.~Tissue biopsies will then be obtained from the wounds prior to the first treatment, immediately after the first treatment, immediately prior to the subsequent treatment, and immediately after the second treatment. These will then be sent to Pathogenius for molecular analysis of wound microflora using polymerase chain reaction and sequencing.~Pain will be assessed during debridement by recording the Numerical Rating Scale for pain assessment."
11312290|NCT03182582|EG000|Reported Event|Laser Debridement|Laser debridement was performed at 200-um until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
11312291|NCT03182582|EG001|Reported Event|Sharp Debridement|Sharp debridement was performed via a scalpel/curette until punctate bleeding is visualized. Pain was assessed during debridement by recording the Numerical Rating Scale for pain assessment.
11312292|NCT03182725|BG000|Baseline|Placebo in Arm A, Ivabradine in Arm B|"In the first Arm, Patient will consume one placebo pill twice a day for one month.~Placebo: A substance that has no therapeutic effect and will act as a control.~In the second arm, patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node."
11312293|NCT03182725|BG001|Baseline|Ivabradine in Arm A, Placebo in Arm B|"In the first arm of the study, patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.~In the second arm, patient will consume one placebo pill twice a day for one month.~Placebo: A substance that has no therapeutic effect and will act as a control."
11312294|NCT03182725|BG002|Baseline|Total|Total of all reporting groups
11312295|NCT03182725|FG000|Participant Flow|Placebo in Arm A, Ivabradine in Arm B|"In the first Arm, Patient will consume one placebo pill twice a day for one month. After the first arm, there will be a one-week washout. After washout, the patient will commence Arm B where they consume ne dose of ivabradine twice a day for one month.~Placebo: A substance that has no therapeutic effect and will act as a control.~In the second arm, patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node."
11312296|NCT03182725|FG001|Participant Flow|Ivabradine in Arm A, Placebo in Arm B|"Patient will consume one dose of Ivabradine twice a day for one month. In the first Arm, Patient will consume one dose of ivabradine twice a day for one month. After the first arm, there will be a one-week washout. After washout, the patient will commence Arm B where they consume one placebo pill twice a day for one month~Placebo: A substance that has no therapeutic effect and will act as a control.~In the second arm, patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node."
11312297|NCT03182725|OG000|Outcome|Placebo|"In the first Arm, Patient will consume one placebo pill twice a day for one month.~Placebo: A substance that has no therapeutic effect and will act as a control."
11312298|NCT03182725|OG001|Outcome|Ivabradine|"Patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node."
11312299|NCT03182725|EG000|Reported Event|Placebo|"Patient will consume one placebo pill twice a day for one month.~Placebo: A substance that has no therapeutic effect and will act as a control."
11312300|NCT03182725|EG001|Reported Event|Ivabradine|"Patient will consume one dose of Ivabradine twice a day for one month.~Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node."
11312301|NCT03182738|BG000|Baseline|Intervention|"VIP app that delivers HIV-related symptom strategies~VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies"
10823110|NCT00082017|OG000|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
10823111|NCT00082017|OG001|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
10823112|NCT00082017|OG000|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
10823113|NCT00082017|EG000|Reported Event|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
10823114|NCT00082173|BG000|Baseline|Experimental Arm (Moxi)|
10823115|NCT00082173|BG001|Baseline|Control Arm (EMB)|
10823116|NCT00082173|BG002|Baseline|Total|Total of all reporting groups
10823117|NCT00082173|FG000|Participant Flow|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
10823118|NCT00082173|FG001|Participant Flow|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
10823119|NCT00082173|OG000|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
10823120|NCT00082173|OG001|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
10823121|NCT00082173|EG000|Reported Event|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
10823122|NCT00082173|EG001|Reported Event|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
10823123|NCT00082329|BG000|Baseline|G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
10823124|NCT00082329|FG000|Participant Flow|G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
10823125|NCT00082329|OG000|Outcome|G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
10823126|NCT00082329|EG000|Reported Event|G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
10823127|NCT00082342|BG000|Baseline|Real tDCS|Subjects received real transcranial direct current stimulation
10823128|NCT00082342|BG001|Baseline|Sham tDCS|Subjects received sham transcranial direct current stimulation
10823129|NCT00082342|BG002|Baseline|Total|Total of all reporting groups
10823130|NCT00082342|FG000|Participant Flow|Real tDCS|"Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes."
10823131|NCT00082342|FG001|Participant Flow|Sham tDCS|"Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary tingling sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication."
10823132|NCT00082342|OG000|Outcome|Real tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
10823133|NCT00082342|OG001|Outcome|Sham tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
10823134|NCT00082342|OG002|Outcome|Real tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
10823135|NCT00082342|OG003|Outcome|Sham tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
10823136|NCT00082342|OG000|Outcome|Real tDCS While on Medication|The total UPDRS score on medication while receiving real tDCS
10823137|NCT00082342|OG001|Outcome|Sham tDCS While on Medication|The total UPDRS score on medication while receiving sham tDCS
11312302|NCT03182738|BG001|Baseline|Control|"VIP app without HIV-related symptom strategies~VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies"
10823138|NCT00082342|OG002|Outcome|Real tDCS While Off Medication|The total UPDRS score off medication while receiving real tDCS
10823139|NCT00082342|OG003|Outcome|Sham tDCS While Off Medication|The total UPDRS score off medication while receiving sham tDCS
10823140|NCT00082342|OG000|Outcome|Real tDCS While on Medication|The motor UPDRS score on medication while receiving real tDCS
10823141|NCT00082342|OG001|Outcome|Sham tDCS While on Medication|The motor UPDRS score on medication while receiving sham tDCS
10823142|NCT00082342|OG002|Outcome|Real tDCS While Off Medication|The motor UPDRS score off medication while receiving real tDCS
10823143|NCT00082342|OG003|Outcome|Sham tDCS While Off Medication|The motor UPDRS score off medication while receiving sham tDCS
10823144|NCT00082342|OG000|Outcome|Real tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving real tDCS.
10823145|NCT00082342|OG001|Outcome|Sham tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving sham tDCS.
10823146|NCT00082342|OG002|Outcome|Real tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving real tDCS.
10823147|NCT00082342|OG003|Outcome|Sham tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving sham tDCS.
10823148|NCT00082342|EG000|Reported Event|Real tDCS|Subjects received real transcranial direct current stimulation
10823149|NCT00082342|EG001|Reported Event|Sham tDCS|Subjects received sham transcranial direct current stimulation
10823150|NCT00082355|BG000|Baseline|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
10823151|NCT00082355|FG000|Participant Flow|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
10823152|NCT00082355|OG000|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
10823153|NCT00082355|EG000|Reported Event|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
10823154|NCT00082368|BG000|Baseline|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
10823155|NCT00082368|FG000|Participant Flow|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
10823156|NCT00082368|OG000|Outcome|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
10823157|NCT00082368|EG000|Reported Event|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
10823158|NCT00082381|BG000|Baseline|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
10823159|NCT00082381|BG001|Baseline|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
10823160|NCT00082381|BG002|Baseline|Total|Total of all reporting groups
10823161|NCT00082381|FG000|Participant Flow|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
10823162|NCT00082381|FG001|Participant Flow|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
10823163|NCT00082381|OG000|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
10823164|NCT00082381|OG001|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
10823165|NCT00082381|EG000|Reported Event|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
10823166|NCT00082381|EG001|Reported Event|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
10823167|NCT00082407|BG000|Baseline|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
10823168|NCT00082407|BG001|Baseline|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
10823169|NCT00082407|BG002|Baseline|Total|Total of all reporting groups
10823170|NCT00082407|FG000|Participant Flow|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
10823171|NCT00082407|FG001|Participant Flow|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
11312303|NCT03182738|BG002|Baseline|Total|Total of all reporting groups
11312304|NCT03182738|FG000|Participant Flow|Intervention|"VIP app that delivers HIV-related symptom strategies~VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies"
11312305|NCT03182738|FG001|Participant Flow|Control|"VIP app without HIV-related symptom strategies~VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies"
11312306|NCT03182738|OG000|Outcome|Intervention|"VIP app that delivers HIV-related symptom strategies~VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies"
11312307|NCT03182738|OG001|Outcome|Control|"VIP app without HIV-related symptom strategies~VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies"
11312308|NCT03182738|EG000|Reported Event|Intervention|"VIP app that delivers HIV-related symptom strategies~VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies"
11312309|NCT03182738|EG001|Reported Event|Control|"VIP app without HIV-related symptom strategies~VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies"
11312310|NCT03182920|BG000|Baseline|Group 1 Elderly|Placebo on Day 1 of 1 of 2 dosing periods or 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods.
11312311|NCT03182920|BG001|Baseline|200 mg Lasmiditan (Group 2 Young)|200 mg of lasmiditan on Day 1.
11312312|NCT03182920|BG002|Baseline|Total|Total of all reporting groups
11312313|NCT03182920|FG000|Participant Flow|Sequence 1: Group 1 Elderly|Placebo on day 1 of period 1 200 mg of lasmiditan on Day 1 of period 2.
10823172|NCT00082407|OG000|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
11312314|NCT03182920|FG001|Participant Flow|Sequence 2: Group 1 Elderly|200 mg of lasmiditan on Day 1 of period 1. Placebo on Day 1 of period 2.
11312315|NCT03182920|FG002|Participant Flow|200 mg Lasmiditan (Group 2 Young)|200 mg of lasmiditan on Day 1.
11312316|NCT03182920|OG000|Outcome|200 mg Lasmiditan (Group 1 Elderly)|200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
11312317|NCT03182920|OG001|Outcome|200 mg Lasmiditan (Group 2 Young)|200 mg of lasmiditan on Day 1.
11312318|NCT03182920|EG000|Reported Event|Placebo (Group 1 Elderly)|Placebo on Day 1 of 1 of 2 dosing periods.
11312319|NCT03182920|EG001|Reported Event|200 mg Lasmiditan (Group 1 Elderly)|200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
11312320|NCT03182920|EG002|Reported Event|200 mg Lasmiditan (Group 2 Young)|200 mg of lasmiditan on Day 1.
11312321|NCT03182933|BG000|Baseline|Liposomal Bupivacaine Group|"20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312322|NCT03182933|BG001|Baseline|Standard Bupivacaine Group|"20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312323|NCT03182933|BG002|Baseline|Total|Total of all reporting groups
11312324|NCT03182933|FG000|Participant Flow|Liposomal Bupivacaine Group|"20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312325|NCT03182933|FG001|Participant Flow|Standard Bupivacaine Group|"20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
10823173|NCT00082407|OG001|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
10823174|NCT00082407|EG000|Reported Event|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
10823175|NCT00082407|EG001|Reported Event|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
10823176|NCT00082433|BG000|Baseline|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823177|NCT00082433|BG001|Baseline|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823178|NCT00082433|BG002|Baseline|Total|Total of all reporting groups
10823179|NCT00082433|FG000|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823180|NCT00082433|FG001|Participant Flow|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823181|NCT00082433|OG000|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823182|NCT00082433|OG001|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
10823183|NCT00082433|EG000|Reported Event|Capecitabine|
10823184|NCT00082433|EG001|Reported Event|Ixabepilone + Capecitabine|
10823185|NCT00082628|BG000|Baseline|Period I: Placebo|Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
10823186|NCT00082628|BG001|Baseline|Period I: Serostim® 4 mg|Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
10823187|NCT00082628|BG002|Baseline|Total|Total of all reporting groups
10823188|NCT00082628|FG000|Participant Flow|Period I: Placebo|Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
10823189|NCT00082628|FG001|Participant Flow|Period I: Serostim® 4 mg|Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
10823190|NCT00082628|FG002|Participant Flow|Period II: Serostim® 4 mg to Placebo|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
10823191|NCT00082628|FG003|Participant Flow|Period II: Serostim® 4 mg to Serostim® 2 mg|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
10823192|NCT00082628|FG004|Participant Flow|Period II: Placebo to Placebo/Serostim® 4 mg|All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
10823193|NCT00082628|OG000|Outcome|Period I: Placebo|Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
10823194|NCT00082628|OG001|Outcome|Period I: Serostim® 4 mg|Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
10823195|NCT00082628|OG000|Outcome|Period II: Serostim® 4 mg to Placebo|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
10823196|NCT00082628|OG001|Outcome|Period II: Serostim® 4 mg to Serostim® 2 mg|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
10823197|NCT00082628|EG000|Reported Event|Period I: Placebo (Week 1 to 12)|Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
10823198|NCT00082628|EG001|Reported Event|Period I: Serostim® 4 mg (Week 1 to 12)|Subjects received serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
10823199|NCT00082628|EG002|Reported Event|Period II: Serostim® 4 mg to Placebo (Week 12 to 36)|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
10823200|NCT00082628|EG003|Reported Event|Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36)|All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
10823201|NCT00082628|EG004|Reported Event|Period II: Placebo to Placebo (Week 12 to Week 24)|All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks in Period II.
10823202|NCT00082628|EG005|Reported Event|Period II: Placebo to Serostim® 4 mg (Week 24 to 36)|All subjects who were initially randomized to Placebo arm in Period I and received Serostim® 4 mg daily 12 weeks in Period II.
10823203|NCT00082641|BG000|Baseline|Arm I|"Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823204|NCT00082641|BG001|Baseline|Arm II|"Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823205|NCT00082641|BG002|Baseline|Total|Total of all reporting groups
10823206|NCT00082641|FG000|Participant Flow|Arm I|"Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823207|NCT00082641|FG001|Participant Flow|Arm II|"Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823208|NCT00082641|OG000|Outcome|Arm I|"Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823209|NCT00082641|OG001|Outcome|Arm II|"Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823210|NCT00082641|OG000|Outcome|Arm I - Early Vaccine and Arm II - Late Vaccine Administration|"Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823211|NCT00082641|EG000|Reported Event|Arm I|"Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823212|NCT00082641|EG001|Reported Event|Arm II|"Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.~autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules"
10823213|NCT00082758|BG000|Baseline|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823214|NCT00082758|BG001|Baseline|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823215|NCT00082758|BG002|Baseline|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
10823216|NCT00082758|BG003|Baseline|Total|Total of all reporting groups
10823217|NCT00082758|FG000|Participant Flow|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823218|NCT00082758|FG001|Participant Flow|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823219|NCT00082758|FG002|Participant Flow|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
10823220|NCT00082758|OG000|Outcome|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823221|NCT00082758|OG001|Outcome|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823222|NCT00082758|OG002|Outcome|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
10823223|NCT00082758|EG000|Reported Event|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823224|NCT00082758|EG001|Reported Event|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
10823225|NCT00082758|EG002|Reported Event|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
10823226|NCT00082810|BG000|Baseline|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
10823227|NCT00082810|FG000|Participant Flow|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
10823228|NCT00082810|OG000|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
10823229|NCT00082810|OG000|Outcome|Treatment (Tipifarnib, Fulvestrant)|"Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity*.~fulvestrant: Given intramuscularly~tipifarnib: Given IV"
10823230|NCT00082810|EG000|Reported Event|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
10823231|NCT00082888|BG000|Baseline|Aggressive B-cell NHL Group|Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823232|NCT00082888|BG001|Baseline|Indolent B-cell NHL Group|Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823233|NCT00082888|BG002|Baseline|HL/T-cell Lymphoma Group|Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823234|NCT00082888|BG003|Baseline|Total|Total of all reporting groups
10823235|NCT00082888|FG000|Participant Flow|Aggressive B-cell NHL Group|Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823236|NCT00082888|FG001|Participant Flow|Indolent B-cell NHL Group|Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823237|NCT00082888|FG002|Participant Flow|HL/T-cell Lymphoma Group|Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823238|NCT00082888|OG000|Outcome|Aggressive B-cell NHL Group|Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823239|NCT00082888|OG001|Outcome|Indolent B-cell NHL Group|Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823240|NCT00082888|OG002|Outcome|HL/T-cell Lymphoma Group|Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823241|NCT00082888|OG001|Outcome|Indolent B-cell NHL Group|Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion
10823242|NCT00082888|EG000|Reported Event|Aggressive B-cell NHL Group|Patients with aggressive B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823243|NCT00082888|EG001|Reported Event|Indolent B-cell NHL Group|Patients with indolent B-cell NHL receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823244|NCT00082888|EG002|Reported Event|HL/T-cell Lymphoma Group|Patients with HL/T-cell lymphoma receive 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician discretion.
10823245|NCT00083122|BG000|Baseline|Group 1 (Platin Resistant)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823246|NCT00083122|BG001|Baseline|Group 2 (Platin Sensitive)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823247|NCT00083122|BG002|Baseline|Total|Total of all reporting groups
10823248|NCT00083122|FG000|Participant Flow|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823249|NCT00083122|FG001|Participant Flow|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
11312326|NCT03182933|OG000|Outcome|Liposomal Bupivacaine Group|"20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312327|NCT03182933|OG001|Outcome|Standard Bupivacaine Group|"20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312328|NCT03182933|EG000|Reported Event|Liposomal Bupivacaine Group|"20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312329|NCT03182933|EG001|Reported Event|Standard Bupivacaine Group|"20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)~Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization~10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist~In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores~Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1"
11312330|NCT03183063|BG000|Baseline|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed from this cohort for outcomes 1, 4, and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
11312331|NCT03183063|BG001|Baseline|4DCT With BiPAP and SPECT/CT|"Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Data will be analyzed from this cohort for outcome 6 only.~4DCT with BiPAP and SPECT/CT: Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT. Patients will be compared with Cohort 1 (4DCT and SPECT/CT) for objective 4 only."
11312332|NCT03183063|BG002|Baseline|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. 62 with positive CTA results for PE and 62 with negative CTA results for PE will be included. Data will be analyzed from this cohort for outcomes 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312333|NCT03183063|BG003|Baseline|Total|Total of all reporting groups
11312334|NCT03183063|FG000|Participant Flow|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed for objective 1, 4 and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
11312335|NCT03183063|FG001|Participant Flow|4DCT With BiPAP and SPECT/CT|"Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Results in these patients will be analyzed for objective 6 only.~4DCT with BiPAP and SPECT/CT: Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT. These patients will be analyzed for objective 4 only."
11312336|NCT03183063|FG002|Participant Flow|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for objectives 2, 3 and 4.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312337|NCT03183063|OG000|Outcome|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed for outcomes 1,4 and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
10823250|NCT00083122|OG000|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823251|NCT00083122|OG001|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823252|NCT00083122|OG001|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823253|NCT00083122|EG000|Reported Event|Group 1 and Group 2 Combined|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
10823254|NCT00083174|BG000|Baseline|Randomization Period: Exemestane|one 25 mg tablet daily in am
10823255|NCT00083174|BG001|Baseline|Randomization Period: Placebo|one tablet daily in am
10823256|NCT00083174|BG002|Baseline|Total|Total of all reporting groups
10823257|NCT00083174|FG000|Participant Flow|Randomization Period: Exemestane|one 25 mg tablet daily in am
10823258|NCT00083174|FG001|Participant Flow|Randomization Period: Placebo|one tablet daily in am
10823259|NCT00083174|FG002|Participant Flow|Open-label Extension: Exemestane|one 25 mg tablet daily in am
10823260|NCT00083174|OG000|Outcome|Open-label Extension: Exemestane|"one 25 mg tablet daily in am~exemestane: one 25 mg tablet daily in am"
10823261|NCT00083174|OG000|Outcome|Randomization Period: Exemestane|25 mg of exemestane tablet daily
10823262|NCT00083174|OG001|Outcome|Randomization Period: Placebo|Placebo tablet daily
10823263|NCT00083174|OG000|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
10823264|NCT00083174|OG001|Outcome|Randomization Period: Placebo|one tablet daily in am
10823265|NCT00083174|EG000|Reported Event|Randomization Period: Exemestane|one 25 mg tablet daily in am
10823266|NCT00083174|EG001|Reported Event|Randomization Period: Placebo|one tablet daily in am
10823267|NCT00083174|EG002|Reported Event|Open-label Extension: Exemestane|one 25 mg tablet daily in am
10823268|NCT00083226|BG000|Baseline|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
10823269|NCT00083226|FG000|Participant Flow|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
10823270|NCT00083226|OG000|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
10823271|NCT00083226|EG000|Reported Event|Doxorubicin+Bortezomib|Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
10823272|NCT00083382|BG000|Baseline|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
10823273|NCT00083382|FG000|Participant Flow|Thalidomide + Bisphosphonate|"200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy~Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)~Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.~Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise"
10823274|NCT00083382|OG000|Outcome|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
10823275|NCT00083382|EG000|Reported Event|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
10823276|NCT00083551|BG000|Baseline|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
10823277|NCT00083551|BG001|Baseline|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
10823278|NCT00083551|BG002|Baseline|Total|Total of all reporting groups
10823279|NCT00083551|FG000|Participant Flow|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
10823280|NCT00083551|FG001|Participant Flow|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
10823281|NCT00083551|OG000|Outcome|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
10823282|NCT00083551|OG001|Outcome|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
10823283|NCT00083551|EG000|Reported Event|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
10823284|NCT00083551|EG001|Reported Event|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
10823285|NCT00083616|BG000|Baseline|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
10823286|NCT00083616|FG000|Participant Flow|Panitumumab (ABX-EGF)|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
10823287|NCT00083616|OG000|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
10823288|NCT00083616|EG000|Reported Event|Panitumumab|
10823289|NCT00083720|BG000|Baseline|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
10823290|NCT00083720|FG000|Participant Flow|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
10823291|NCT00083720|OG000|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
10823292|NCT00083720|EG000|Reported Event|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
10823293|NCT00083889|BG000|Baseline|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
10823294|NCT00083889|BG001|Baseline|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
10823295|NCT00083889|BG002|Baseline|Total|Total of all reporting groups
10823296|NCT00083889|FG000|Participant Flow|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
10823297|NCT00083889|FG001|Participant Flow|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
10823298|NCT00083889|OG000|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
10823299|NCT00083889|OG001|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
10823300|NCT00083889|OG000|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
10823301|NCT00083889|OG000|Outcome|SU012662|Active metabolite of SU011248
10823302|NCT00083889|OG000|Outcome|Total Drug: SU011248 and SU012662|SU011248 and active metabolite SU012662
10823303|NCT00083889|EG000|Reported Event|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
10823304|NCT00083889|EG001|Reported Event|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
10823305|NCT00084084|BG000|Baseline|Agalsidase Alfa (Cohort 1)|0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
10823306|NCT00084084|FG000|Participant Flow|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
10823307|NCT00084084|OG000|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
10823308|NCT00084084|EG000|Reported Event|Safety Population RB|Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
10823309|NCT00084084|EG001|Reported Event|Transition Safety Population|A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
10823310|NCT00084136|BG000|Baseline|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
10823311|NCT00084136|BG001|Baseline|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
10823312|NCT00084136|BG002|Baseline|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
10823313|NCT00084136|BG003|Baseline|Total|Total of all reporting groups
10823314|NCT00084136|FG000|Participant Flow|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
10823315|NCT00084136|FG001|Participant Flow|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
10823316|NCT00084136|FG002|Participant Flow|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
10823317|NCT00084136|OG000|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
10823318|NCT00084136|OG001|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
10823319|NCT00084136|OG002|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
10823320|NCT00084136|OG001|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
10823321|NCT00084136|EG000|Reported Event|ZDV/3TC+EFV|
10823322|NCT00084136|EG001|Reported Event|ddI+FTC+ATV|
10823323|NCT00084136|EG002|Reported Event|TDF/FTC+EFV|
10823324|NCT00084149|BG000|Baseline|A: Cyclosporine|"Arm A will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823325|NCT00084149|BG001|Baseline|B: Placebo|"Arm B will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823326|NCT00084149|BG002|Baseline|Total|Total of all reporting groups
10823327|NCT00084149|FG000|Participant Flow|Cyclosporine|"The Cyclosporine arm (Arm A) will receive one tablet of abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT), (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily, and liquid cyclosporin A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823328|NCT00084149|FG001|Participant Flow|No Cyclosporine|"The No Cyclosporine arm (Arm B) will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823329|NCT00084149|OG000|Outcome|Cyclosporine|"Cyclosporine arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily, and liquid Cyclosporine A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823330|NCT00084149|OG001|Outcome|No Cyclosporine|"No Cyclosporine arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of Lopinavir/Ritonavir (LPV/r) twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823331|NCT00084149|OG000|Outcome|Cyclosporine|"Cyclosporine arm (Arm A) will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823332|NCT00084149|OG001|Outcome|No Cyclosporine|"No Cyclosporine arm (Arm B) will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823333|NCT00084149|OG000|Outcome|Cyclosporine|"Cyclosporine arm will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823334|NCT00084149|OG001|Outcome|No Cyclosporine|"No Cyclosporine arm will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823335|NCT00084149|EG000|Reported Event|Cyclosporine|"Cyclosporine will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823336|NCT00084149|EG001|Reported Event|No Cyclosporine|"No Cyclosporine arm will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks~Abacavir sulfate, Lamivudine, and Zidovudine: antiretroviral therapy~Lopinavir/Ritonavir: antiretroviral therapy"
10823337|NCT00084266|BG000|Baseline|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823338|NCT00084266|BG001|Baseline|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823339|NCT00084266|BG002|Baseline|Total|Total of all reporting groups
10823340|NCT00084266|FG000|Participant Flow|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823341|NCT00084266|FG001|Participant Flow|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823342|NCT00084266|OG000|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823343|NCT00084266|OG001|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823344|NCT00084266|EG000|Reported Event|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823345|NCT00084266|EG001|Reported Event|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823346|NCT00084318|BG000|Baseline|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
10823347|NCT00084318|BG001|Baseline|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
10823348|NCT00084318|BG002|Baseline|Total|Total of all reporting groups
10823349|NCT00084318|FG000|Participant Flow|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
10823350|NCT00084318|FG001|Participant Flow|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
10823351|NCT00084318|OG000|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
10823352|NCT00084318|OG001|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
10823353|NCT00084318|OG000|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
10823354|NCT00084318|OG001|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
10823355|NCT00084318|EG000|Reported Event|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
10823356|NCT00084318|EG001|Reported Event|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
10823357|NCT00084383|BG000|Baseline|GVAX Pancreatic Cancer Vaccine|
10823358|NCT00084383|FG000|Participant Flow|GVAX Pancreatic Cancer Vaccine|
10823359|NCT00084383|OG000|Outcome|GVAX Pancreatic Cancer Vaccine|
10823360|NCT00084383|EG000|Reported Event|GVAX Pancreatic Cancer Vaccine|
10823361|NCT00084409|BG000|Baseline|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823362|NCT00084409|BG001|Baseline|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823363|NCT00084409|BG002|Baseline|Total|Total of all reporting groups
10823364|NCT00084409|FG000|Participant Flow|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823365|NCT00084409|FG001|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823366|NCT00084409|OG000|Outcome|Iloprost|
10823367|NCT00084409|OG001|Outcome|Placebo|
10823368|NCT00084409|OG000|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823369|NCT00084409|OG001|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823370|NCT00084409|EG000|Reported Event|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823371|NCT00084409|EG001|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
10823372|NCT00084487|BG000|Baseline|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
10823373|NCT00084487|FG000|Participant Flow|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
10823374|NCT00084487|OG000|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
10823375|NCT00084487|EG000|Reported Event|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
10823376|NCT00084552|BG000|Baseline|s-IMRT|"Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823377|NCT00084552|BG001|Baseline|ETS-IMRT|"Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823378|NCT00084552|BG002|Baseline|Total|Total of all reporting groups
10823379|NCT00084552|FG000|Participant Flow|Standard IMRT (S-IMRT)|"Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823380|NCT00084552|FG001|Participant Flow|Erectile Tissue Sparing IMRT (ETS-IMRT)|"Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823381|NCT00084552|OG000|Outcome|s-IMRT|"Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823382|NCT00084552|OG001|Outcome|ETS-IMRT|"Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823383|NCT00084552|EG000|Reported Event|s-IMRT|"Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823384|NCT00084552|EG001|Reported Event|ETS-IMRT|"Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.~radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks."
10823385|NCT00084617|BG000|Baseline|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10823386|NCT00084617|FG000|Participant Flow|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10823387|NCT00084617|OG000|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10823388|NCT00084617|EG000|Reported Event|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10823389|NCT00084682|BG000|Baseline|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
10823390|NCT00084682|FG000|Participant Flow|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
10823391|NCT00084682|OG000|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
10823392|NCT00084682|OG000|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
10823393|NCT00084682|EG000|Reported Event|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
10823394|NCT00084747|BG000|Baseline|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
10823395|NCT00084747|FG000|Participant Flow|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
10823396|NCT00084747|OG000|Outcome|Bortezomib|autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
10823397|NCT00084747|OG000|Outcome|Bortezomib|bortezomib
10823398|NCT00084747|EG000|Reported Event|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
10823399|NCT00084838|BG000|Baseline|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
11312338|NCT03183063|OG001|Outcome|4DCT With BiPAP and SPECT/CT|"Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Results in these patients will be analyzed for objective 6 only.~4DCT with BiPAP and SPECT/CT: Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT. These patients will be analyzed for objective 4 only."
11312339|NCT03183063|OG002|Outcome|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for outcomes 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312340|NCT03183063|OG002|Outcome|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for outcomes 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE."
11312341|NCT03183063|OG000|Outcome|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. This data will be analyzed for outcomes 1,4 and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
11312342|NCT03183063|OG002|Outcome|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. This data will be analyzed for outcomes 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312343|NCT03183063|OG000|Outcome|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed for objectives 1, 4 and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
11312344|NCT03183063|OG001|Outcome|4DCT With BiPAP and SPECT/CT|"Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Results in these patients will be analyzed for objective 6 only.~4DCT with BiPAP and SPECT/CT: Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT"
11312345|NCT03183063|OG002|Outcome|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for objectives 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312346|NCT03183063|EG000|Reported Event|4DCT and SPECT/CT|"Anticipated15 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Both 4DCT scans will be obtained with normal breathing. Data will be analyzed for objectives 1, 4 and 5.~4DCT and SPECT/CT: Each patient will receive two 4DCT followed by SPECT/CT."
11312347|NCT03183063|EG001|Reported Event|4DCT With BiPAP and SPECT/CT|"Anticipated 5 patients with segmental or lobar pulmonary emboli on CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. The second of the two 4DCT scans will be obtained with positive airway breathing via BiPAP. Results in these patients will be analyzed for objective 6 only.~4DCT with BiPAP and SPECT/CT: Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT"
11312348|NCT03183063|EG002|Reported Event|4DCT With CTA in Suspected PE|"Anticipated 124 participants with CTA ordered/performed for suspected PE will be enrolled to have 4DCT. Goal for analysis is 62 with positive CTA results for PE and 62 with negative CTA results for PE. Data will be analyzed for objectives 2 and 3.~4DCT with CTA in suspected PE: Each patient will receive 4DCT before or after CTA for suspected PE"
11312349|NCT03183518|BG000|Baseline|All Participants|Baseline population includes safety population (N=36). The Safety population included all participants who received any study product.
11312350|NCT03183518|FG000|Participant Flow|All Participants|Included all participants who were randomized to receive the study treatment. In this study, the test product (cosmetic facial cleanser) and the negative control (saline solution) were randomly assigned and dispensed to 2 separated cells within a single semi-occlusive patch that was subsequently applied to the upper back (test site).
11312351|NCT03183518|OG000|Outcome|Test Product|This arm included data from all the test sites were test product was applied.
11312352|NCT03183518|OG001|Outcome|Negative Control|This arm included data from all the test sites were negative control was applied.
11312353|NCT03183518|EG000|Reported Event|All Participants|The safety population (N=36). The Safety population included all participants who received any study product.
11312354|NCT03183869|BG000|Baseline|Early Intervention|"Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
11312355|NCT03183869|BG001|Baseline|Late Intervention|"At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
11312356|NCT03183869|BG002|Baseline|Total|Total of all reporting groups
11312357|NCT03183869|FG000|Participant Flow|Early Intervention|"Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
11312358|NCT03183869|FG001|Participant Flow|Late Intervention|"At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
11312359|NCT03183869|OG000|Outcome|Pre-FMT|"Cytokine values before fecal microbial transplants.~Fecal microbiota: fecal microbial transplantation"
11312360|NCT03183869|OG001|Outcome|Post-FMT|"Cytokine values after fecal microbial transplants.~Fecal microbiota: fecal microbial transplantation"
10823400|NCT00084838|FG000|Participant Flow|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
10823401|NCT00084838|OG000|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
10823402|NCT00084838|OG000|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
10823403|NCT00084838|OG000|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
10823404|NCT00084838|EG000|Reported Event|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
10823405|NCT00084864|BG000|Baseline|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
10823406|NCT00084864|BG001|Baseline|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
10823407|NCT00084864|BG002|Baseline|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
10823408|NCT00084864|BG003|Baseline|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
10823409|NCT00084864|BG004|Baseline|Total|Total of all reporting groups
10823410|NCT00084864|FG000|Participant Flow|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
10823411|NCT00084864|FG001|Participant Flow|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
10823412|NCT00084864|FG002|Participant Flow|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
10823413|NCT00084864|FG003|Participant Flow|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
10823414|NCT00084864|OG000|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
10823415|NCT00084864|OG001|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
10823416|NCT00084864|OG002|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
10823417|NCT00084864|OG003|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
10823418|NCT00084864|EG000|Reported Event|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
10823419|NCT00084864|EG001|Reported Event|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
10823420|NCT00084864|EG002|Reported Event|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
10823421|NCT00084864|EG003|Reported Event|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
10823422|NCT00084929|BG000|Baseline|CT Colonography|"CT colonography conducted during the same assessment as colonoscopy.~CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment."
10823423|NCT00084929|FG000|Participant Flow|CT Colonography|"CT colonography conducted during the same assessment as colonoscopy.~CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment."
10823424|NCT00084929|OG000|Outcome|CT Colonography|CT colonography conducted during the same assessment as colonoscopy. CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
10823425|NCT00084929|OG000|Outcome|CT Colonography (Per Lesion)|CT colonography conducted during the same assessment as colonoscopy. CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
10823426|NCT00084929|OG000|Outcome|High Performance (HP) Readers|Readers were divided into two groups: HP readers had both a sensitivity and specificity of > 85% for detecting polyps 10 mm and larger while NHP readers had a sensitivity and/or specificity < 85%.
10823427|NCT00084929|OG001|Outcome|Non-high Performance (NHP) Readers|NHP readers had a sensitivity and/or specificity < 85%.
10823428|NCT00084929|EG000|Reported Event|CT Colonography|"CT colonography conducted during the same assessment as colonoscopy.~CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment."
10823429|NCT00084929|EG001|Reported Event|Colonoscopy|Colonoscopy conducted during the same assessment as CT colonography
10823430|NCT00085098|BG000|Baseline|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
10823431|NCT00085098|BG001|Baseline|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
10823432|NCT00085098|BG002|Baseline|Total|Total of all reporting groups
10823433|NCT00085098|FG000|Participant Flow|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
10823434|NCT00085098|FG001|Participant Flow|Regimen B (Chemotherapy Plus Radiotherapy)|Courses 1,2:Patients (PTS) receive carboplatin IV over 1 hour on days 1-2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, PTS with complete response (CR) undergo low-dose radiation therapy 5 days a week for 5 weeks. PTS with minimal residual disease (MRD), a PR, or stable disease (SD) receive chemotherapy courses 3,4. Courses 3,4:PTS receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2-3 and filgrastim (G-CSF) subcutaneous (SC) or IV on day 4 continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. PTS achieving a CR or MRD proceed to reduced-dose radiotherapy. PTS with a partial response (PR), SD or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A.Reduced-dose radiation therapy: Within 6 weeks of starting course 4, PTS undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks.
10823435|NCT00085098|OG000|Outcome|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
10823436|NCT00085098|OG001|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
10823437|NCT00085098|OG000|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks."
10823438|NCT00085098|OG000|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF), subcutaneous (SC) or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
10823439|NCT00085098|OG000|Outcome|Regimen A (Radiotherapy Only)|"Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.~radiation therapy: Patients undergo radiotherapy 5 days a week"
10823440|NCT00085098|EG000|Reported Event|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
10823441|NCT00085098|EG001|Reported Event|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
10823442|NCT00085254|BG000|Baseline|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823443|NCT00085254|BG001|Baseline|Arm 2 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823444|NCT00085254|BG002|Baseline|Arm 3 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823445|NCT00085254|BG003|Baseline|Total|Total of all reporting groups
10823446|NCT00085254|FG000|Participant Flow|Arm 1 (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823447|NCT00085254|FG001|Participant Flow|Arm 2 - Phase II (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10842514|NCT00247416|BG001|Baseline|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
10842515|NCT00247416|BG002|Baseline|Total|Total of all reporting groups
10823448|NCT00085254|FG002|Participant Flow|Arm 3 - Phase II (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823449|NCT00085254|OG000|Outcome|Arm 1 500mg (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 500mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
10823450|NCT00085254|OG001|Outcome|ARM 2 1000mg (Safety run-in)|"INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 1000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
10823451|NCT00085254|OG002|Outcome|Arm 3 2000mg (Safety Run-In)|"INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
10823452|NCT00085254|OG000|Outcome|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823453|NCT00085254|OG000|Outcome|Arm 1 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823454|NCT00085254|OG001|Outcome|Arm 2 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823455|NCT00085254|OG000|Outcome|Arm 1- Phase 2 (500mg)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823456|NCT00085254|OG001|Outcome|Arm 2 - Phase 2 (2000mg)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823457|NCT00085254|OG000|Outcome|Arm 4 (Overall Study)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823458|NCT00085254|EG000|Reported Event|Dose 500|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823459|NCT00085254|EG001|Reported Event|Dose 1000|"INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823460|NCT00085254|EG002|Reported Event|Dose 2000|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10823461|NCT00085293|BG000|Baseline|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
10823462|NCT00085293|FG000|Participant Flow|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
10823463|NCT00085293|OG000|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
10823464|NCT00085293|EG000|Reported Event|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
10823465|NCT00085410|BG000|Baseline|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
10823466|NCT00085410|FG000|Participant Flow|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
10823467|NCT00085410|OG000|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
10823468|NCT00085410|OG000|Outcome|Arm I|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.~bortezomib: Given IV"
10823469|NCT00085410|EG000|Reported Event|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
10823470|NCT00085423|BG000|Baseline|Lymphodepleting Chemotherapy + High Dose IL-2|intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
10823471|NCT00085423|FG000|Participant Flow|Lymphodepleting Chemotherapy + High Dose Interleukin-2|"Lymphodepleting chemotherapy + high dose interleukin-2:~Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery."
10823472|NCT00085423|OG000|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
10823473|NCT00085423|EG000|Reported Event|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
10823474|NCT00085436|BG000|Baseline|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
10823475|NCT00085436|FG000|Participant Flow|All Patients Treated With DC Vaccine|All patients treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
10823476|NCT00085436|OG000|Outcome|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
10823477|NCT00085436|OG000|Outcome|Vaccine, Aldesleukin-2, Interferon-a|"All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.~Characterization of lymphocyte sub population by flow cytometry."
10823478|NCT00085436|EG000|Reported Event|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
10823479|NCT00085540|BG000|Baseline|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
10823480|NCT00085540|BG001|Baseline|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
10823481|NCT00085540|BG002|Baseline|Total|Total of all reporting groups
10823482|NCT00085540|FG000|Participant Flow|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
10823483|NCT00085540|FG001|Participant Flow|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
10823484|NCT00085540|OG000|Outcome|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
10823485|NCT00085540|OG000|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
10823486|NCT00085540|EG000|Reported Event|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
10823487|NCT00085540|EG001|Reported Event|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
10823488|NCT00085566|BG000|Baseline|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823489|NCT00085566|BG001|Baseline|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823490|NCT00085566|BG002|Baseline|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823491|NCT00085566|BG003|Baseline|Total|Total of all reporting groups
10823492|NCT00085566|FG000|Participant Flow|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823493|NCT00085566|FG001|Participant Flow|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823494|NCT00085566|FG002|Participant Flow|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823495|NCT00085566|OG000|Outcome|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823496|NCT00085566|OG001|Outcome|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823497|NCT00085566|OG002|Outcome|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823498|NCT00085566|EG000|Reported Event|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823499|NCT00085566|EG001|Reported Event|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823500|NCT00085566|EG002|Reported Event|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
10823501|NCT00085644|BG000|Baseline|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
10823502|NCT00085644|BG001|Baseline|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
10823503|NCT00085644|BG002|Baseline|Total|Total of all reporting groups
10823504|NCT00085644|FG000|Participant Flow|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
10823505|NCT00085644|FG001|Participant Flow|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
10823506|NCT00085644|FG002|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
10823507|NCT00085644|OG000|Outcome|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
10823508|NCT00085644|OG001|Outcome|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
10823509|NCT00085644|OG000|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
10823510|NCT00085644|OG000|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
10823511|NCT00085644|EG000|Reported Event|Any Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
10823512|NCT00085709|BG000|Baseline|Ara-C+Daunomycin+Mylotarg|Ara-C+Daunomycin+Mylotarg
10823513|NCT00085709|BG001|Baseline|ARA-C+Daunomycin|ARA-C+Daunomycin
10823514|NCT00085709|BG002|Baseline|Total|Total of all reporting groups
10823515|NCT00085709|FG000|Participant Flow|Ara-C+Daunomycin+Mylotarg|Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
10823516|NCT00085709|FG001|Participant Flow|ARA-C+Daunomycin|Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
10823517|NCT00085709|OG000|Outcome|Post-consolidation GO|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
10823518|NCT00085709|OG001|Outcome|Post-consolidation Observation|Patients did not receive any post-consolidation therapy
10823519|NCT00085709|OG000|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
10823520|NCT00085709|OG001|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
10823521|NCT00085709|OG000|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
10823522|NCT00085709|OG001|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
10823523|NCT00085709|OG002|Outcome|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
10823524|NCT00085709|OG003|Outcome|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
10823525|NCT00085709|EG000|Reported Event|Induction 7 + 3 + G.O.|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
10823526|NCT00085709|EG001|Reported Event|Induction 7 + 3|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
10823527|NCT00085709|EG002|Reported Event|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
10823528|NCT00085709|EG003|Reported Event|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
10823529|NCT00085839|BG000|Baseline|Erlotinib|Erlotinib 150 mg/day continuous therapy
10823530|NCT00085839|BG001|Baseline|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
10823531|NCT00085839|BG002|Baseline|Total|Total of all reporting groups
10823532|NCT00085839|FG000|Participant Flow|Erlotinib|Erlotinib 150 mg/day continuous therapy
10823533|NCT00085839|FG001|Participant Flow|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
10823534|NCT00085839|OG000|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
10823535|NCT00085839|OG001|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
10823536|NCT00085839|EG000|Reported Event|Erlotinib|Erlotinib 150 mg/day continuous therapy
10823537|NCT00085839|EG001|Reported Event|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
10823538|NCT00085917|BG000|Baseline|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
10823539|NCT00085917|BG001|Baseline|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
10823540|NCT00085917|BG002|Baseline|Total|Total of all reporting groups
10823541|NCT00085917|FG000|Participant Flow|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
10823542|NCT00085917|FG001|Participant Flow|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
10823543|NCT00085917|OG000|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
10823544|NCT00085917|OG001|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
10823545|NCT00085917|EG000|Reported Event|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
10823546|NCT00085917|EG001|Reported Event|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
10823547|NCT00086047|BG000|Baseline|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
10823548|NCT00086047|BG001|Baseline|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
10823549|NCT00086047|BG002|Baseline|Total|Total of all reporting groups
10823550|NCT00086047|FG000|Participant Flow|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
10823551|NCT00086047|FG001|Participant Flow|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
10823552|NCT00086047|OG000|Outcome|Coping Skills Training|Consists of training in pain management skills using cognitive-behavioral therapy techniques
10823553|NCT00086047|OG001|Outcome|Fibromyalgia Education|Consists of education about fibromyalgia and its management
10823554|NCT00086047|EG000|Reported Event|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
10823555|NCT00086047|EG001|Reported Event|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
10823556|NCT00086138|BG000|Baseline|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
10823557|NCT00086138|BG001|Baseline|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
10823558|NCT00086138|BG002|Baseline|Total|Total of all reporting groups
10823559|NCT00086138|FG000|Participant Flow|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
10823560|NCT00086138|FG001|Participant Flow|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
10823561|NCT00086138|OG000|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
10823562|NCT00086138|OG001|Outcome|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
10823563|NCT00086138|EG000|Reported Event|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
10823564|NCT00086138|EG001|Reported Event|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
10823565|NCT00086190|BG000|Baseline|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823566|NCT00086190|BG001|Baseline|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823567|NCT00086190|BG002|Baseline|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823568|NCT00086190|BG003|Baseline|Total|Total of all reporting groups
10823569|NCT00086190|FG000|Participant Flow|Paroxetine|Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
10823570|NCT00086190|FG001|Participant Flow|Venlafaxine Extended Release|Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
10823571|NCT00086190|FG002|Participant Flow|Placebo|Placebo was made to match treatment options.
10823572|NCT00086190|OG000|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
10823573|NCT00086190|OG001|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
10823574|NCT00086190|OG002|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
10823575|NCT00086190|EG000|Reported Event|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823576|NCT00086190|EG001|Reported Event|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823577|NCT00086190|EG002|Reported Event|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
10823578|NCT00086281|BG000|Baseline|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823579|NCT00086281|BG001|Baseline|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823580|NCT00086281|BG002|Baseline|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
10823581|NCT00086281|BG003|Baseline|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823582|NCT00086281|BG004|Baseline|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823583|NCT00086281|BG005|Baseline|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
11312361|NCT03183869|EG000|Reported Event|Early Intervention|"Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
10823584|NCT00086281|BG006|Baseline|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823585|NCT00086281|BG007|Baseline|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823586|NCT00086281|BG008|Baseline|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823587|NCT00086281|BG009|Baseline|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823588|NCT00086281|BG010|Baseline|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823589|NCT00086281|BG011|Baseline|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823590|NCT00086281|BG012|Baseline|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
10823591|NCT00086281|BG013|Baseline|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823592|NCT00086281|BG014|Baseline|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823593|NCT00086281|BG015|Baseline|Total|Total of all reporting groups
10823594|NCT00086281|FG000|Participant Flow|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823595|NCT00086281|FG001|Participant Flow|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823596|NCT00086281|FG002|Participant Flow|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
10823597|NCT00086281|FG003|Participant Flow|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823598|NCT00086281|FG004|Participant Flow|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823599|NCT00086281|FG005|Participant Flow|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
10823600|NCT00086281|FG006|Participant Flow|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823601|NCT00086281|FG007|Participant Flow|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823602|NCT00086281|FG008|Participant Flow|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823603|NCT00086281|FG009|Participant Flow|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
10823604|NCT00086281|FG010|Participant Flow|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823605|NCT00086281|FG011|Participant Flow|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823606|NCT00086281|FG012|Participant Flow|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
10823607|NCT00086281|FG013|Participant Flow|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
10823608|NCT00086281|FG014|Participant Flow|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
10823609|NCT00086281|OG000|Outcome|Placebo|Placebo
10823610|NCT00086281|OG001|Outcome|Xyrem|Xyrem
10823611|NCT00086281|OG002|Outcome|Xyrem + Modafinil|Xyrem + Modafinil
10823612|NCT00086281|OG003|Outcome|Zolpidem + Placebo|Zolpidem + Placebo
10823613|NCT00086281|EG000|Reported Event|Placebo|Placebo
10823614|NCT00086281|EG001|Reported Event|Xyrem|Xyrem
10823615|NCT00086281|EG002|Reported Event|X + M|Xyrem + Modafinil
10823616|NCT00086281|EG003|Reported Event|Z + P|Zolpidem + Placebo
10823617|NCT00086307|BG000|Baseline|Pramipexole|Patients receive pramipexole and placebo.
10823618|NCT00086307|BG001|Baseline|Escitalopram|Patients receive escitalopram and placebo.
10823619|NCT00086307|BG002|Baseline|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
10823620|NCT00086307|BG003|Baseline|Total|Total of all reporting groups
10823621|NCT00086307|FG000|Participant Flow|Pramipexole|Patients receive pramipexole and placebo.
10823622|NCT00086307|FG001|Participant Flow|Escitalopram|Patients receive escitalopram and placebo.
10823623|NCT00086307|FG002|Participant Flow|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
10823624|NCT00086307|OG000|Outcome|Pramipexole|Patients receive pramipexole and placebo.
10823625|NCT00086307|OG001|Outcome|Escitalopram|Patients receive escitalopram and placebo.
10823626|NCT00086307|OG002|Outcome|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
10823627|NCT00086307|EG000|Reported Event|Pramipexole|Patients receive pramipexole and placebo.
10823628|NCT00086307|EG001|Reported Event|Escitalopram|Patients receive escitalopram and placebo.
10823629|NCT00086307|EG002|Reported Event|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
10823630|NCT00086346|BG000|Baseline|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
10823631|NCT00086346|BG001|Baseline|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
10823632|NCT00086346|BG002|Baseline|Total|Total of all reporting groups
10823633|NCT00086346|FG000|Participant Flow|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
10823634|NCT00086346|FG001|Participant Flow|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
10823635|NCT00086346|OG000|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
10823636|NCT00086346|OG001|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
10823637|NCT00086346|EG000|Reported Event|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
10823638|NCT00086346|EG001|Reported Event|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
10823639|NCT00086385|BG000|Baseline|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823640|NCT00086385|BG001|Baseline|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823641|NCT00086385|BG002|Baseline|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823642|NCT00086385|BG003|Baseline|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823643|NCT00086385|BG004|Baseline|Total|Total of all reporting groups
10823644|NCT00086385|FG000|Participant Flow|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823645|NCT00086385|FG001|Participant Flow|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823646|NCT00086385|FG002|Participant Flow|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
11312362|NCT03183869|EG001|Reported Event|Late Intervention|"At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.~Fecal microbiota: fecal microbial transplantation"
11312363|NCT03183908|BG000|Baseline|Adjuvanted Influenza Vaccine (FLUAD)|"In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.~FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312364|NCT03183908|BG001|Baseline|High-dose Influenza Vaccine (Fluzone HD)|"In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.~Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312365|NCT03183908|BG002|Baseline|Total|Total of all reporting groups
11312366|NCT03183908|FG000|Participant Flow|Influenza Vaccine, Adjuvanted (FLUAD®)|"In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.~FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312367|NCT03183908|FG001|Participant Flow|High-Dose Influenza Vaccine (Fluzone HD)|"In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.~Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312368|NCT03183908|OG000|Outcome|Adjuvanted Influenza Vaccine (FLUAD®)|"In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.~FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312369|NCT03183908|OG001|Outcome|High-dose Influenza Vaccine (Fluzone® HD)|"In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.~Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312370|NCT03183908|OG000|Outcome|Influenza Vaccine, Adjuvanted (FLUAD®)|"In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.~FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312371|NCT03183908|OG001|Outcome|High-Dose Influenza Vaccine (Fluzone HD)|"In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.~Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312372|NCT03183908|OG000|Outcome|Adjuvanted Influenza Vaccine (FLUAD®)|"In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.~FLUAD®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312373|NCT03183908|OG001|Outcome|High-dose Influenza Vaccine (Fluzone® HD)|"In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.~Fluzone® High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312374|NCT03183908|EG000|Reported Event|Adjuvanted Influenza Vaccine (FLUAD®)|"In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.~FLUAD®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312375|NCT03183908|EG001|Reported Event|High-dose Influenza Vaccine (Fluzone® HD)|"In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.~Fluzone® High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine"
11312376|NCT03184077|BG000|Baseline|Polyglactic 910 (Vicryl Rapide)|Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
11312377|NCT03184077|BG001|Baseline|Monocryl|Laceration Repair with Monocryl: Monocryl suture for laceration repair
11312378|NCT03184077|BG002|Baseline|Total|Total of all reporting groups
11312379|NCT03184077|FG000|Participant Flow|Polyglactic 910 (Vicryl Rapide)|Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
11312380|NCT03184077|FG001|Participant Flow|Monocryl|Laceration Repair with Monocryl: Monocryl suture for laceration repair
11312381|NCT03184077|OG000|Outcome|Polyglactin 910 (Vicryl Rapide)|Laceration Repair with Polyglactin 910 (Vicryl Rapide): Polyglactin 910 suture for laceration repair
11312382|NCT03184077|OG001|Outcome|Poliglecaprone 25|Laceration Repair with poliglecaprone 25: poliglecaprone 25 suture for laceration repair
11312383|NCT03184077|EG000|Reported Event|Polyglactic 910 (Vicryl Rapide)|Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
11312384|NCT03184077|EG001|Reported Event|Monocryl|Laceration Repair with Monocryl: Monocryl suture for laceration repair
11333296|NCT03511521|EG001|Reported Event|Basal/Bolus Insulin|"Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U [units]/kg) according to the Prednisone dose (mg/day) as follows:~Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone >80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.~glargine: basal insulin~Insulin Aspart: prandial insulin"
11333297|NCT03511638|BG000|Baseline|Bausch & Lomb DVisc40|"Ophthalmic viscosurgical device~Bausch & Lomb DVisc40: Ophthalmic viscosurgical device"
11333298|NCT03511638|BG001|Baseline|Alcon VISCOAT®|"Ophthalmic viscosurgical device~Alcon VISCOAT®: Ophthalmic viscosurgical device"
11333299|NCT03511638|BG002|Baseline|Total|Total of all reporting groups
11333300|NCT03511638|FG000|Participant Flow|Bausch & Lomb DVisc40|"Ophthalmic viscosurgical device~Bausch & Lomb DVisc40: Ophthalmic viscosurgical device"
11333301|NCT03511638|FG001|Participant Flow|Alcon VISCOAT®|"Ophthalmic viscosurgical device~Alcon VISCOAT®: Ophthalmic viscosurgical device"
11333302|NCT03511638|OG000|Outcome|Bausch & Lomb DVisc40|"Ophthalmic viscosurgical device~Bausch & Lomb DVisc40: Ophthalmic viscosurgical device"
11333303|NCT03511638|OG001|Outcome|Alcon VISCOAT®|"Ophthalmic viscosurgical device~Alcon VISCOAT®: Ophthalmic viscosurgical device"
10823647|NCT00086385|FG003|Participant Flow|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823648|NCT00086385|OG000|Outcome|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823649|NCT00086385|OG001|Outcome|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823650|NCT00086385|OG002|Outcome|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823651|NCT00086385|OG003|Outcome|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823652|NCT00086385|EG000|Reported Event|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823653|NCT00086385|EG001|Reported Event|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823654|NCT00086385|EG002|Reported Event|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823655|NCT00086385|EG003|Reported Event|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
10823656|NCT00086411|BG000|Baseline|1: Bup+MM|bupropion and MM with placebo patch
10823657|NCT00086411|BG001|Baseline|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
10823658|NCT00086411|BG002|Baseline|3 Patch+MM|patch and MM with placebo pills
10823659|NCT00086411|BG003|Baseline|4 Patch+Mayo|patch and Mayo counseling with placebo patch
10823660|NCT00086411|BG004|Baseline|Total|Total of all reporting groups
10823661|NCT00086411|FG000|Participant Flow|1 Bup+MM|bupropion and MM with placebo patch
10823662|NCT00086411|FG001|Participant Flow|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
10823663|NCT00086411|FG002|Participant Flow|3 Patch+MM|patch and MM with placebo pills
10823664|NCT00086411|FG003|Participant Flow|4 Patch+Mayo|patch and Mayo counseling with placebo patch
10823665|NCT00086411|OG000|Outcome|1: Bup+MM|bupropion and MM with placebo patch
10823666|NCT00086411|OG001|Outcome|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
10823667|NCT00086411|OG002|Outcome|3 Patch+mm|patch and MM with placebo pills
10823668|NCT00086411|OG003|Outcome|4 Patch+Mayo|patch and Mayo counseling with placebo patch
10823669|NCT00086411|OG002|Outcome|3 Patch+MM|patch and MM with placebo pills
10823670|NCT00086411|EG000|Reported Event|1: Bup+MM|bupropion and MM with placebo patch
10823671|NCT00086411|EG001|Reported Event|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
10823672|NCT00086411|EG002|Reported Event|3 Patch+mm|patch and MM with placebo pills
10823673|NCT00086411|EG003|Reported Event|4 Patch+Mayo|patch and Mayo counseling with placebo patch
10823674|NCT00086450|BG000|Baseline|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
10823675|NCT00086450|BG001|Baseline|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
10823676|NCT00086450|BG002|Baseline|Total|Total of all reporting groups
10823677|NCT00086450|FG000|Participant Flow|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
10823678|NCT00086450|FG001|Participant Flow|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
10823679|NCT00086450|OG000|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
10823680|NCT00086450|OG001|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
10823681|NCT00086450|EG000|Reported Event|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
10823682|NCT00086450|EG001|Reported Event|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
10823683|NCT00086502|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823684|NCT00086502|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823685|NCT00086502|BG002|Baseline|Total|Total of all reporting groups
10823686|NCT00086502|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823687|NCT00086502|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823688|NCT00086502|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823689|NCT00086502|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823690|NCT00086502|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823691|NCT00086502|EG001|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
10823692|NCT00086515|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
10823693|NCT00086515|BG001|Baseline|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
10823694|NCT00086515|BG002|Baseline|Total|Total of all reporting groups
10823695|NCT00086515|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
10823696|NCT00086515|FG001|Participant Flow|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
10823697|NCT00086515|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
10823698|NCT00086515|OG001|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
10823699|NCT00086515|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
10823700|NCT00086515|EG001|Reported Event|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
11217698|NCT02315664|OG000|Outcome|Immediate Intervention Group|Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.
10823701|NCT00086580|BG000|Baseline|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
10823702|NCT00086580|BG001|Baseline|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
10823703|NCT00086580|BG002|Baseline|Total|Total of all reporting groups
10823704|NCT00086580|FG000|Participant Flow|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
10823705|NCT00086580|FG001|Participant Flow|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
10823706|NCT00086580|OG000|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
10823707|NCT00086580|OG001|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
10823708|NCT00086580|EG000|Reported Event|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
10823709|NCT00086580|EG001|Reported Event|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
10842516|NCT00247416|FG000|Participant Flow|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
10842517|NCT00247416|FG001|Participant Flow|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
10842518|NCT00247416|OG000|Outcome|1 No Dex|"No Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
10842519|NCT00247416|OG001|Outcome|2 Dex|"Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
10842520|NCT00247416|OG000|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
10842521|NCT00247416|OG001|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
10842522|NCT00247416|EG000|Reported Event|1 No Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
10842523|NCT00247416|EG001|Reported Event|2 Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
10842524|NCT00247611|BG000|Baseline|Control|Participants will receive the control condition
10842525|NCT00247611|BG001|Baseline|Intervention|Participants will receive the LifeWindows Intervention sessions
10842526|NCT00247611|BG002|Baseline|Total|Total of all reporting groups
10842527|NCT00247611|FG000|Participant Flow|Control|Participants will receive the control condition
10842528|NCT00247611|FG001|Participant Flow|Intervention|Participants will receive the LifeWindows Intervention sessions
10842529|NCT00247611|OG000|Outcome|Control (ITT Sample %)|287 (94%) of the 304 randomized to control
10842530|NCT00247611|OG001|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
10842531|NCT00247611|OG002|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
10842532|NCT00247611|OG003|Outcome|Intervention (On Protocol)|152 (55%) of the ITT included intervention arm participants
10842533|NCT00247611|OG000|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
10842534|NCT00247611|OG003|Outcome|Intervention (On Protocol Sample)|152 (55%) of the ITT included intervention arm participants
10842535|NCT00247611|OG000|Outcome|On Protocol (OP) Sample|Post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions
10842536|NCT00247611|OG001|Outcome|Total Excluded From OP Sample|ITT sample excluded from the post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions (ITT - OP sample)
10842537|NCT00247611|EG000|Reported Event|Control|Participants will receive the control condition
10842538|NCT00247611|EG001|Reported Event|Intervention|Participants will receive the LifeWindows Intervention sessions
10842539|NCT00247624|BG000|Baseline|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
10842540|NCT00247624|BG001|Baseline|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
10842541|NCT00247624|BG002|Baseline|Total|Total of all reporting groups
10842542|NCT00247624|FG000|Participant Flow|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
10842543|NCT00247624|FG001|Participant Flow|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
10823710|NCT00086619|BG000|Baseline|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
10823711|NCT00086619|BG001|Baseline|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
10823712|NCT00086619|BG002|Baseline|Total|Total of all reporting groups
10823713|NCT00086619|FG000|Participant Flow|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
10823714|NCT00086619|FG001|Participant Flow|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
10823715|NCT00086619|OG000|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
10823716|NCT00086619|OG001|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
10823717|NCT00086619|EG000|Reported Event|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
10823718|NCT00086619|EG001|Reported Event|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
10823719|NCT00086684|BG000|Baseline|PLACEBO|
10823720|NCT00086684|BG001|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
10823721|NCT00086684|BG002|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
10823722|NCT00086684|BG003|Baseline|Total|Total of all reporting groups
10823723|NCT00086684|FG000|Participant Flow|PLACEBO|
10823724|NCT00086684|FG001|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
10823725|NCT00086684|FG002|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
10823726|NCT00086684|OG000|Outcome|PLACEBO|
10823727|NCT00086684|OG001|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
10823728|NCT00086684|OG002|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
10823729|NCT00086684|EG000|Reported Event|PLACEBO|
10823730|NCT00086684|EG001|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
10823731|NCT00086684|EG002|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
10823732|NCT00086957|BG000|Baseline|Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2|"trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.~docetaxel: 75 mg/m^2 every three weeks, or 60 mg/m^2 every three weeks depending on study findings~gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings"
10823733|NCT00086957|FG000|Participant Flow|Phase I - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
10823734|NCT00086957|FG001|Participant Flow|Phase I - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
10823735|NCT00086957|FG002|Participant Flow|Phase II - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
10823736|NCT00086957|OG000|Outcome|Phase I: Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
10823737|NCT00086957|OG001|Outcome|Phase I: Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
10823738|NCT00086957|OG000|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
10823739|NCT00086957|OG000|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m2 intravenously every 3 weeks.
10823740|NCT00086957|OG000|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
10823741|NCT00086957|EG000|Reported Event|Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
10823742|NCT00086957|EG001|Reported Event|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
10823743|NCT00086996|BG000|Baseline|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
10823744|NCT00086996|FG000|Participant Flow|Chemo Plus RT, Surgery, Chemo|"Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.~Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.~Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m^2/day by 24-hour infusion continuously on days 1-36."
10823745|NCT00086996|OG000|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
10823746|NCT00086996|EG000|Reported Event|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
10823747|NCT00087022|BG000|Baseline|Intervention|"Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).~girentuximab: Given IV"
10823748|NCT00087022|BG001|Baseline|Placebo|"Patients receive placebo IV over 15 minutes once weekly for 24 weeks.~placebo: Given IV"
10823749|NCT00087022|BG002|Baseline|Total|Total of all reporting groups
10823750|NCT00087022|FG000|Participant Flow|Intervention|"Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex, girentuximab, and WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).~girentuximab: Given IV"
10823751|NCT00087022|FG001|Participant Flow|Placebo|"Patients receive placebo IV over 15 minutes once weekly for 24 weeks.~placebo: Given IV"
10823752|NCT00087022|OG000|Outcome|Intervention|"Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).~girentuximab: Given IV"
10823753|NCT00087022|OG001|Outcome|Placebo|"Patients receive placebo IV over 15 minutes once weekly for 24 weeks.~placebo: Given IV"
10823754|NCT00087022|EG000|Reported Event|Intervention|"Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).~girentuximab: Given IV"
10823755|NCT00087022|EG001|Reported Event|Placebo|"Patients receive placebo IV over 15 minutes once weekly for 24 weeks.~placebo: Given IV"
10823756|NCT00087126|BG000|Baseline|Topotecan Hydrochloride|Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
10823757|NCT00087126|FG000|Participant Flow|Topotecan Hydrochloride|Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
10823758|NCT00087126|OG000|Outcome|Topotecan Hydrochloride|Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
10823759|NCT00087126|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
11333304|NCT03511638|EG000|Reported Event|Bausch & Lomb DVisc40|"Ophthalmic viscosurgical device~Bausch & Lomb DVisc40: Ophthalmic viscosurgical device"
10823760|NCT00087126|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10823761|NCT00087126|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10823762|NCT00087126|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10823763|NCT00087126|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
10823764|NCT00087126|EG000|Reported Event|Topotecan Hydrochloride|Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
10823765|NCT00087139|BG000|Baseline|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823766|NCT00087139|BG001|Baseline|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823767|NCT00087139|BG002|Baseline|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823768|NCT00087139|BG003|Baseline|Total|Total of all reporting groups
10823769|NCT00087139|FG000|Participant Flow|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823770|NCT00087139|FG001|Participant Flow|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823771|NCT00087139|FG002|Participant Flow|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823772|NCT00087139|OG000|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823773|NCT00087139|OG001|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823774|NCT00087139|OG002|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
10823775|NCT00087139|EG000|Reported Event|Ixabepilone|All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
10823776|NCT00087152|BG000|Baseline|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
10823777|NCT00087152|FG000|Participant Flow|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
10823778|NCT00087152|OG000|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
10823779|NCT00087152|OG000|Outcome|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
10823780|NCT00087152|EG000|Reported Event|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
10823781|NCT00087438|BG000|Baseline|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
10823782|NCT00087438|FG000|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
10823783|NCT00087438|OG000|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
10823784|NCT00087438|OG000|Outcome|Stereotactic Body Radiation Therapy (SBRT)|20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
10823785|NCT00087438|OG000|Outcome|Stereotactic Body Radiation Therapy (SBRT)|20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
10823786|NCT00087438|EG000|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
10823787|NCT00087490|BG000|Baseline|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823788|NCT00087490|BG001|Baseline|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823789|NCT00087490|BG002|Baseline|Total|Total of all reporting groups
10823790|NCT00087490|FG000|Participant Flow|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823791|NCT00087490|FG001|Participant Flow|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823792|NCT00087490|OG000|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823793|NCT00087490|OG001|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823794|NCT00087490|EG000|Reported Event|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823795|NCT00087490|EG001|Reported Event|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator's discretion.
10823796|NCT00087516|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823797|NCT00087516|BG001|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823798|NCT00087516|BG002|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
10823799|NCT00087516|BG003|Baseline|Total|Total of all reporting groups
10823800|NCT00087516|FG000|Participant Flow|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823801|NCT00087516|FG001|Participant Flow|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823802|NCT00087516|FG002|Participant Flow|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
10823803|NCT00087516|FG003|Participant Flow|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
10842544|NCT00247624|OG000|Outcome|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
10823804|NCT00087516|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823805|NCT00087516|OG001|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823806|NCT00087516|OG002|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
10823807|NCT00087516|OG000|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823808|NCT00087516|OG001|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823809|NCT00087516|OG002|Outcome|Placebo/ Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
10823810|NCT00087516|OG003|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
10823811|NCT00087516|OG002|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
10823812|NCT00087516|EG000|Reported Event|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823813|NCT00087516|EG001|Reported Event|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
10823814|NCT00087516|EG002|Reported Event|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
10823815|NCT00087516|EG003|Reported Event|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
10823816|NCT00087529|BG000|Baseline|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823817|NCT00087529|BG001|Baseline|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823818|NCT00087529|BG002|Baseline|Total|Total of all reporting groups
10823819|NCT00087529|FG000|Participant Flow|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823820|NCT00087529|FG001|Participant Flow|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823821|NCT00087529|OG000|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823822|NCT00087529|OG001|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823823|NCT00087529|EG000|Reported Event|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823824|NCT00087529|EG001|Reported Event|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
10823825|NCT00087555|BG000|Baseline|Placebo|Placebo taken as two equally divided nightly doses
10823826|NCT00087555|BG001|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10823827|NCT00087555|BG002|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10823828|NCT00087555|BG003|Baseline|Total|Total of all reporting groups
10823829|NCT00087555|FG000|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
11333305|NCT03511638|EG001|Reported Event|Alcon VISCOAT®|"Ophthalmic viscosurgical device~Alcon VISCOAT®: Ophthalmic viscosurgical device"
10823830|NCT00087555|FG001|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10823831|NCT00087555|FG002|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10823832|NCT00087555|OG000|Outcome|Placebo|Placebo taken as two equally divided nightly doses
10823833|NCT00087555|OG001|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10823834|NCT00087555|OG002|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10823835|NCT00087555|EG000|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
10823836|NCT00087555|EG001|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
10823837|NCT00087555|EG002|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
10823838|NCT00087568|BG000|Baseline|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
10823839|NCT00087568|BG001|Baseline|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
10823840|NCT00087568|BG002|Baseline|Total|Total of all reporting groups
10823841|NCT00087568|FG000|Participant Flow|Non-Responders|Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks.
10823842|NCT00087568|FG001|Participant Flow|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
10823843|NCT00087568|OG000|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
10823844|NCT00087568|OG001|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
10823845|NCT00087568|EG000|Reported Event|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
10823846|NCT00087568|EG001|Reported Event|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
10823847|NCT00087594|BG000|Baseline|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823848|NCT00087594|BG001|Baseline|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823849|NCT00087594|BG002|Baseline|Total|Total of all reporting groups
10823850|NCT00087594|FG000|Participant Flow|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823851|NCT00087594|FG001|Participant Flow|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823852|NCT00087594|OG000|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823853|NCT00087594|OG001|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823854|NCT00087594|EG000|Reported Event|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
10823855|NCT00087594|EG001|Reported Event|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
11217699|NCT02315664|OG001|Outcome|Delayed Intervention Group|Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.
10842545|NCT00247624|OG001|Outcome|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
10842546|NCT00247624|EG000|Reported Event|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
10842547|NCT00247624|EG001|Reported Event|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
10823856|NCT00087607|BG000|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823857|NCT00087607|BG001|Baseline|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823858|NCT00087607|BG002|Baseline|Total|Total of all reporting groups
10823859|NCT00087607|FG000|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a (40 kD) [Pegasys] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin [Copegus] 1000 or 1200 milligram (mg)/day), orally, [according to body weight, lesser than or greater than/equal to (< or >/=) 75 kilogram (kg), respectively] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823860|NCT00087607|FG001|Participant Flow|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b (12 kD) [PEG-Intron] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin [Rebetol] 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823861|NCT00087607|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823862|NCT00087607|OG001|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823863|NCT00087607|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823864|NCT00087607|OG001|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823865|NCT00087607|OG000|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823866|NCT00087607|OG001|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10842548|NCT00247676|BG000|Baseline|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
11312385|NCT03184428|BG000|Baseline|Implantation of IOL L313|"Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the treatment for postoperative observation and survey.~Postoperative observation and survey: For postoperative observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a Nd: YAG-Laser-Capsulotomy after Cataract-Surgery or not."
11312386|NCT03184428|FG000|Participant Flow|L313-Implantation|Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens.
11312387|NCT03184428|OG000|Outcome|Implantation of IOL L313 Age<55|Patients age<55 who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.
11312388|NCT03184428|OG001|Outcome|Implantation of IOL L313 Age≥55|Patients age≥55 who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.
11312389|NCT03184428|OG000|Outcome|Capsulotomy Rate/Age|Correlation coefficient between capsulotomy rate and age
11312390|NCT03184428|OG001|Outcome|Capsulotomy Rate/Gender|Correlation coefficient between capsulotomy rate and gender
11312391|NCT03184428|OG002|Outcome|Capsulotomy Rate/Cutting Lenth|Correlation coefficient between capsulotomy rate and cutting length
11312392|NCT03184428|OG003|Outcome|Capsulotomy Rate/Core Hardness|Correlation coefficient between capsulotomy rate and core hardness
11312393|NCT03184428|OG004|Outcome|Capsulotomy Rate/Duration of Whole Operation|Correlation coefficient between capsulotomy rate and duration of whole operation
11312394|NCT03184428|OG005|Outcome|Capsulotomy Rate/Time of Phaco-emulsification|Correlation coefficient between capsulotomy rate and time of phaco-emulsification
11312395|NCT03184428|OG006|Outcome|Capsulotomy Rate/Phaco-energy|Correlation coefficient between capsulotomy rate and phaco-energy
11312396|NCT03184428|OG007|Outcome|Capsulotomy Rate/Phaco-machine|Correlation coefficient between capsulotomy rate and phaco-machine
11312397|NCT03184428|OG008|Outcome|Capsulotomy Rate/Combination With Other op|Correlation coefficient between capsulotomy rate and L-313 implantation in combination with other op
11312398|NCT03184428|OG009|Outcome|Capsulotomy Rate/Surgeon|Correlation coefficient between capsulotomy rate and surgeon
11312399|NCT03184428|OG010|Outcome|Correlation Rate/Power of IOL|Correlation coefficient between capsulotomy rate and power of IOL
11312400|NCT03184428|EG000|Reported Event|Implantation of IOL L313|Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.
11312401|NCT03184441|BG000|Baseline|Premie Pouch|"All participants will receive the experimental treatment with the Premie Pouch device.~Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant."
10842549|NCT00247676|FG000|Participant Flow|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
11312402|NCT03184441|FG000|Participant Flow|Premie Pouch|"All participants will received the experimental treatment with the Premie Pouch device.~Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant."
11312403|NCT03184441|OG000|Outcome|All Subjects Recieved the Study Device|Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
11312404|NCT03184441|OG000|Outcome|Premie Pouch|"All participants will received the experimental treatment with the Premie Pouch device.~Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant."
11312405|NCT03184441|OG000|Outcome|All Subjects Recieved the Study Device|"All participants will received the experimental treatment with the Premie Pouch device.~Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant."
11312406|NCT03184441|OG000|Outcome|Premie Pouch|Nurses caring for participants in the study
11312407|NCT03184441|EG000|Reported Event|Premie Pouch|"All participants will received the experimental treatment with the Premie Pouch device.~Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant."
10823867|NCT00087607|EG000|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823868|NCT00087607|EG001|Reported Event|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
10823869|NCT00087633|BG000|Baseline|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
10823870|NCT00087633|BG001|Baseline|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
10823871|NCT00087633|BG002|Baseline|Total|Total of all reporting groups
10823872|NCT00087633|FG000|Participant Flow|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
10823873|NCT00087633|FG001|Participant Flow|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
10823874|NCT00087633|OG000|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
10823875|NCT00087633|OG001|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
10823876|NCT00087633|EG000|Reported Event|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
10823877|NCT00087633|EG001|Reported Event|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
10823878|NCT00087646|BG000|Baseline|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
10823879|NCT00087646|BG001|Baseline|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
10823880|NCT00087646|BG002|Baseline|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
10823881|NCT00087646|BG003|Baseline|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
10823882|NCT00087646|BG004|Baseline|Total|Total of all reporting groups
10823883|NCT00087646|FG000|Participant Flow|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
10823884|NCT00087646|FG001|Participant Flow|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
10823885|NCT00087646|FG002|Participant Flow|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
10823886|NCT00087646|FG003|Participant Flow|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
10823887|NCT00087646|OG000|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
10823888|NCT00087646|OG001|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
10823889|NCT00087646|OG000|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
10823890|NCT00087646|OG001|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
10823891|NCT00087646|OG000|Outcome|Group A + Group C|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks."
10823892|NCT00087646|OG001|Outcome|Group B + Group D|"Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
10823893|NCT00087646|OG001|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
10823894|NCT00087646|OG002|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
10823895|NCT00087646|OG003|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
10823896|NCT00087646|EG000|Reported Event|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
10823897|NCT00087646|EG001|Reported Event|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
10823898|NCT00087646|EG002|Reported Event|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
10823899|NCT00087646|EG003|Reported Event|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
10823900|NCT00087672|BG000|Baseline|CC-5013|10 mg orally daily
10823901|NCT00087672|FG000|Participant Flow|CC-5013|10 mg orally daily
10823902|NCT00087672|OG000|Outcome|CC-5013|10 mg orally daily
10823903|NCT00087672|EG000|Reported Event|CC-5013|10 mg orally daily
10823904|NCT00087685|BG000|Baseline|RAD001|10 mg orally daily/28-day cycles
10823905|NCT00087685|FG000|Participant Flow|RAD001|10 mg orally daily/28-day cycles
10823906|NCT00087685|OG000|Outcome|RAD001|10 mg orally daily/28-day cycles
10823907|NCT00087685|EG000|Reported Event|RAD001|10 mg orally daily/28-day cycles
10823908|NCT00087698|BG000|Baseline|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
10823909|NCT00087698|FG000|Participant Flow|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
10823910|NCT00087698|OG000|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
10823911|NCT00087698|EG000|Reported Event|Pemetrexed|pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy
10823912|NCT00088153|BG000|Baseline|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
10823913|NCT00088153|BG001|Baseline|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
10823914|NCT00088153|BG002|Baseline|Total|Total of all reporting groups
10823915|NCT00088153|FG000|Participant Flow|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
10823916|NCT00088153|FG001|Participant Flow|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
10823917|NCT00088153|OG000|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
10823918|NCT00088153|OG001|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
10823919|NCT00088153|EG000|Reported Event|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
10823920|NCT00088153|EG001|Reported Event|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
10823921|NCT00088166|BG000|Baseline|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
10823922|NCT00088166|BG001|Baseline|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
10823923|NCT00088166|BG002|Baseline|Total|Total of all reporting groups
10823924|NCT00088166|FG000|Participant Flow|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
10823925|NCT00088166|FG001|Participant Flow|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
10823926|NCT00088166|OG000|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
10823927|NCT00088166|OG001|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
10823928|NCT00088166|EG000|Reported Event|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
10823929|NCT00088166|EG001|Reported Event|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
10823930|NCT00088205|BG000|Baseline|Enzastaurin|500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
10823931|NCT00088205|FG000|Participant Flow|Enzastaurin|500 milligrams (mg) oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
10823932|NCT00088205|OG000|Outcome|Enzastaurin|500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
10823933|NCT00088205|EG000|Reported Event|Enzastaurin|500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred.
10823934|NCT00088218|BG000|Baseline|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
10823935|NCT00088218|BG001|Baseline|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
11312408|NCT03184519|BG000|Baseline|All Patients|"Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.~Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer."
11312409|NCT03184519|FG000|Participant Flow|All Patients|"Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.~Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer."
10823936|NCT00088218|BG002|Baseline|Total|Total of all reporting groups
10823937|NCT00088218|FG000|Participant Flow|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
10823938|NCT00088218|FG001|Participant Flow|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
10823939|NCT00088218|OG000|Outcome|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
10823940|NCT00088218|OG001|Outcome|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
10823941|NCT00088218|EG000|Reported Event|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
10823942|NCT00088218|EG001|Reported Event|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
10823943|NCT00088374|BG000|Baseline|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
10823944|NCT00088374|FG000|Participant Flow|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
10823945|NCT00088374|OG000|Outcome|Participants With VHL Associated Renal Tumors|
10823946|NCT00088374|EG000|Reported Event|Participants With VHL Associated Renal Tumors|
10823947|NCT00088413|BG000|Baseline|Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823948|NCT00088413|BG001|Baseline|Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823949|NCT00088413|BG002|Baseline|Breast Cohort|Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.
10823950|NCT00088413|BG003|Baseline|Ovarian Cohort|Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
10823951|NCT00088413|BG004|Baseline|Total|Total of all reporting groups
10823952|NCT00088413|FG000|Participant Flow|Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
11312410|NCT03184519|OG000|Outcome|All Patients|"Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.~Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer."
11312411|NCT03184519|EG000|Reported Event|All Patients|"Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.~Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer."
11312412|NCT03184558|BG000|Baseline|Bemcentinib + Pembrolizumab|Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed.
11312413|NCT03184558|FG000|Participant Flow|Bemcentinib + Pembrolizumab|Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed.
11312414|NCT03184558|OG000|Outcome|Bemcentinib + Pembrolizumab|Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed.
11312415|NCT03184558|EG000|Reported Event|Bemcentinib + Pembrolizumab|Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed.
11312416|NCT03184701|BG000|Baseline|Experimental|"Patients assigned to this arm receive the intervention in addition to routine standard of care. Telehealth based remote monitoring of symptoms and brain tests is the intervention in this study. A device with preloaded questionaires will be given to patients randomized to this group. The patients will respond on a daily basis for the 3 months of intervention phase.~Telehealth: Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach."
11312417|NCT03184701|FG000|Participant Flow|Intervention Arm|All study participants were included in this intervention arm, and given a device with questions to respond.
11312418|NCT03184701|OG000|Outcome|Intervention Arm|All study participants were included in this intervention arm, and given a device with questions to respond.
11312419|NCT03184701|EG000|Reported Event|Experimental|"Patients assigned to this arm receive the intervention in addition to routine standard of care. Telehealth based remote monitoring of symptoms and brain tests is the intervention in this study. A device with preloaded questionaires will be given to patients randomized to this group. The patients will respond on a daily basis for the 3 months of intervention phase.~Telehealth: Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach."
11312420|NCT03184987|BG000|Baseline|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
11312421|NCT03184987|BG001|Baseline|FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg|Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312422|NCT03184987|BG002|Baseline|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312423|NCT03184987|BG003|Baseline|Total|Total of all reporting groups
11312424|NCT03184987|FG000|Participant Flow|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 microgram (mcg) inhalation powder via ELLIPTA, once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
11312425|NCT03184987|FG001|Participant Flow|FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg|Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312426|NCT03184987|FG002|Participant Flow|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312427|NCT03184987|OG000|Outcome|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
11312428|NCT03184987|OG001|Outcome|FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg|Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312429|NCT03184987|OG002|Outcome|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312430|NCT03184987|EG000|Reported Event|FF/UMEC/VI 100/62.5/25 mcg|Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
11312431|NCT03184987|EG001|Reported Event|FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg|Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312432|NCT03184987|EG002|Reported Event|FF/UMEC/VI 200/62.5/25 mcg|Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
11312433|NCT03185065|BG000|Baseline|Arm A|"amantadine, placebo, modafinil, methylphenidate~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312434|NCT03185065|BG001|Baseline|Arm B|"placebo, methylphenidate, amantadine, modafinil~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312435|NCT03185065|BG002|Baseline|Arm C|"modafinil, amantadine, methylphenidate, placebo~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312436|NCT03185065|BG003|Baseline|Arm D|"methylphenidate, modafinil, placebo and amantadine~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312437|NCT03185065|BG004|Baseline|Total|Total of all reporting groups
11312438|NCT03185065|FG000|Participant Flow|Arm A|"amantadine, placebo, modafinil, methylphenidate~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312439|NCT03185065|FG001|Participant Flow|Arm B|"placebo, methylphenidate, amantadine, modafinil~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312440|NCT03185065|FG002|Participant Flow|Arm C|"modafinil, amantadine, methylphenidate, placebo~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312441|NCT03185065|FG003|Participant Flow|Arm D|"methylphenidate, modafinil, placebo and amantadine~Amantadine: 100 mg of amantadine increased to 200 mg of amantadine, if tolerated~Modafinil: 100 mg of modafinil increased to 200 mg of modafinil, if tolerated~Methylphenidate: 5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated~Placebos: 1 placebo capsule increased to max of 2 capsules twice daily"
11312442|NCT03185065|OG000|Outcome|Placebo|1 placebo capsule increased to max of 2 capsules twice daily
10823953|NCT00088413|FG001|Participant Flow|Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823954|NCT00088413|FG002|Participant Flow|Breast Cohort|Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.
10823955|NCT00088413|FG003|Participant Flow|Ovarian Cohort|Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
10823956|NCT00088413|OG000|Outcome|Breast Cancer Cohort|Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.
10823957|NCT00088413|OG001|Outcome|Ovarian Cancer Cohort|Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
10823958|NCT00088413|OG000|Outcome|Colorectal Cancer and Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823959|NCT00088413|OG000|Outcome|Breast Cancer and Ovarian Cancer Cohorts|Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
10823960|NCT00088413|OG000|Outcome|Colorectal Cancer and Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer, or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823961|NCT00088413|OG001|Outcome|Breast Cancer and Ovarian Cancer Cohort|Patients with evaluable, metastatic breast cancer or ovarian cancer who have failed or not a candidate for standard therapy.
10823962|NCT00088413|OG000|Outcome|Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823963|NCT00088413|OG001|Outcome|Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823964|NCT00088413|EG000|Reported Event|Colorectal Cancer vs Non-Colorectal Cancer Cohort|Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
10823965|NCT00088413|EG001|Reported Event|Breast and Ovarian Cohorts|Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
10823966|NCT00088452|BG000|Baseline|Ethosuximide|"Ethosuximide~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup~Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)~Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy."
10823967|NCT00088452|BG001|Baseline|Lamotrigine|"Lamotrigine~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets~Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).~Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy."
10842550|NCT00247676|OG000|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
11312443|NCT03185065|OG001|Outcome|Amantadine|100 mg of amantadine increased to 200 mg of amantadine, if tolerated.
10842551|NCT00247676|EG000|Reported Event|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
10842552|NCT00247962|BG000|Baseline|Etanercept|etanercept 50 mg once weekly
11312444|NCT03185065|OG002|Outcome|Modafinil|100 mg of modafinil increased to 200 mg of modafinil, if tolerated.
10823968|NCT00088452|BG002|Baseline|Valproic Acid|"Valproic acid~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.~Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)~Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy."
10823969|NCT00088452|BG003|Baseline|Total|Total of all reporting groups
10823970|NCT00088452|FG000|Participant Flow|Ethosuximide|"Ethosuximide~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup~Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)~Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy."
10823971|NCT00088452|FG001|Participant Flow|Lamotrigine|"Lamotrigine~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets~Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).~Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy."
10823972|NCT00088452|FG002|Participant Flow|Valproic Acid|"Valproic acid~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.~Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)~Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy."
10823973|NCT00088452|OG000|Outcome|Ethosuximide|"Ethosuximide~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup~Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)~Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy."
10823974|NCT00088452|OG001|Outcome|Lamotrigine|"Lamotrigine~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets~Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).~Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy."
10823975|NCT00088452|OG002|Outcome|Valproic Acid|"Valproic acid~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.~Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)~Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy."
10842553|NCT00247962|BG001|Baseline|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
11312445|NCT03185065|OG003|Outcome|Methylphenidate|5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated.
10842554|NCT00247962|BG002|Baseline|Total|Total of all reporting groups
10842555|NCT00247962|FG000|Participant Flow|Etanercept|etanercept 50 mg once weekly
11312446|NCT03185065|OG000|Outcome|Placebo|1 placebo capsule increased to max of 2 capsules twice daily.
11312447|NCT03185065|EG000|Reported Event|Placebo|1 placebo capsule increased to max of 2 capsules twice daily.
11312448|NCT03185065|EG001|Reported Event|Amantadine|100 mg of amantadine increased to 200 mg of amantadine, if tolerated.
11312449|NCT03185065|EG002|Reported Event|Modafinil|100 mg of modafinil increased to 200 mg of modafinil, if tolerated.
11312450|NCT03185065|EG003|Reported Event|Methylphenidate|5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated.
11312451|NCT03185182|BG000|Baseline|Experimental Group|"185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.~Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects"
10842556|NCT00247962|FG001|Participant Flow|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
10842557|NCT00247962|OG000|Outcome|Etanercept|etanercept 50 mg once weekly
10842558|NCT00247962|OG001|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
10842559|NCT00247962|EG000|Reported Event|Etanercept|etanercept 50 mg once weekly
10842560|NCT00247962|EG001|Reported Event|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
10842561|NCT00248040|BG000|Baseline|Reparixin Continuous Infusion|"Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.772 mg/kg/h was administered for12 hours."
10842562|NCT00248040|BG001|Baseline|Reparixin Intermittent Infusion|"Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours."
10823976|NCT00088452|EG000|Reported Event|Ethosuximide|"Ethosuximide~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup~Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)~Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy."
10823977|NCT00088452|EG001|Reported Event|Lamotrigine|"Lamotrigine~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets~Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).~Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy."
10823978|NCT00088452|EG002|Reported Event|Valproic Acid|"Valproic acid~Frequency and Duration: twice a day, every day for the duration of the study treatment~Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.~Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)~Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy."
10823979|NCT00088465|BG000|Baseline|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
10823980|NCT00088465|FG000|Participant Flow|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
10823981|NCT00088465|OG000|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
10823982|NCT00088465|EG000|Reported Event|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
10823983|NCT00088530|BG000|Baseline|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
10823984|NCT00088530|BG001|Baseline|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
10823985|NCT00088530|BG002|Baseline|Total|Total of all reporting groups
10823986|NCT00088530|FG000|Participant Flow|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)
10823987|NCT00088530|FG001|Participant Flow|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
10823988|NCT00088530|OG000|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
10823989|NCT00088530|OG001|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
10823990|NCT00088530|EG000|Reported Event|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
10823991|NCT00088530|EG001|Reported Event|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
10823992|NCT00088595|BG000|Baseline|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
10823993|NCT00088595|FG000|Participant Flow|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
10823994|NCT00088595|OG000|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
10823995|NCT00088595|OG000|Outcome|Pasireotide 300 - ≤900 μg|SOM230 (Pasireotide), 300 - ≤900 μg / day
10823996|NCT00088595|OG001|Outcome|Pasireotide >900 - ≤1500 μg|SOM230 (Pasireotide), >900 - ≤1500 μg / day
10823997|NCT00088595|OG002|Outcome|Pasireotide >1500 - ≤2400 μg|SOM230 (Pasireotide), >1500 - ≤2400 μg / day
10823998|NCT00088595|OG003|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 300 ug - 2400 ug / day
10823999|NCT00088595|OG000|Outcome|Pasireotide 300-≤900 μg|SOM230 (Pasireotide), 150µg twice daily dose titration up to 450µg twice daily, subcutaneous injection.
10824000|NCT00088595|OG001|Outcome|Pasireotide >900-≤1500 μg|SOM230 (Pasireotide), more than 450µg twice daily dose titration up to 750µg twice daily, subcutaneous injection.
10824001|NCT00088595|OG002|Outcome|Pasireotide >1500-≤2400 μg|SOM230 (Pasireotide), more than 750µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
10824002|NCT00088595|OG003|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
10824003|NCT00088595|EG000|Reported Event|Pasireotide 300 ≤ 900 μg|Pasireotide 300 ≤ 900 μg / day
10824004|NCT00088595|EG001|Reported Event|Pasireotide > 900 ≤ 1500 μg|Pasireotide > 900 ≤ 1500 μg / day
10824005|NCT00088595|EG002|Reported Event|Pasireotide > 1500 ≤ 2400 μg|Pasireotide > 1500 ≤ 2400 μg / day
10824006|NCT00088621|BG000|Baseline|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
10824007|NCT00088621|FG000|Participant Flow|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
10842563|NCT00248040|BG002|Baseline|Placebo Continuous/Intermittent Infusion|Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
10824008|NCT00088621|OG000|Outcome|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
10824009|NCT00088621|EG000|Reported Event|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
10824010|NCT00088634|BG000|Baseline|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
10824011|NCT00088634|BG001|Baseline|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
10824012|NCT00088634|BG002|Baseline|Total|Total of all reporting groups
10824013|NCT00088634|FG000|Participant Flow|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
10824014|NCT00088634|FG001|Participant Flow|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
10824015|NCT00088634|OG000|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
10824016|NCT00088634|OG001|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
10824017|NCT00088634|EG000|Reported Event|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
10824018|NCT00088634|EG001|Reported Event|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
10824019|NCT00088699|BG000|Baseline|Healthy Volunteer|Healthy volunteer patients
10824020|NCT00088699|BG001|Baseline|Major Depressive Disorder (MDD)|Patients diagnosed with Major Depressive Disorder (MDD)
10824021|NCT00088699|BG002|Baseline|Total|Total of all reporting groups
10824022|NCT00088699|FG000|Participant Flow|MDD: Ketamine, Then Placebo|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
10824023|NCT00088699|FG001|Participant Flow|MDD: Placebo, Then Ketamine|Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
10824024|NCT00088699|FG002|Participant Flow|Healthy Volunteers: Ketamine, Then Placebo|Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
10824025|NCT00088699|FG003|Participant Flow|Healthy Volunteers:Placebo, Then Ketamine|Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
10824026|NCT00088699|OG000|Outcome|Ketamine - Healthy Volunteers|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
10824027|NCT00088699|OG001|Outcome|Placebo - Healthy Volunteers|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
10824028|NCT00088699|OG002|Outcome|Ketamine - MDD Patients|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
10824029|NCT00088699|OG003|Outcome|Placebo - MDD Patients|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
10824030|NCT00088699|EG000|Reported Event|Healthy Volunteer: Ketamine|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
10824031|NCT00088699|EG001|Reported Event|MDD: Ketamine|Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
10824032|NCT00088699|EG002|Reported Event|Healthy Volunteer: Placebo|Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
10824033|NCT00088699|EG003|Reported Event|MDD: Placebo|Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
10824034|NCT00088881|BG000|Baseline|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
10824035|NCT00088881|FG000|Participant Flow|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
10824036|NCT00088881|OG000|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
10842564|NCT00248040|BG003|Baseline|Total|Total of all reporting groups
10824037|NCT00088881|EG000|Reported Event|Step 1 - R-CHOP|Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
10824038|NCT00088881|EG001|Reported Event|Step 2 - Zevalin™ Radioimmunotherapy|Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
10824039|NCT00088881|EG002|Reported Event|Step 3 - Radiation Therapy|Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
10824040|NCT00088907|BG000|Baseline|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
10824041|NCT00088907|BG001|Baseline|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
10824042|NCT00088907|BG002|Baseline|Total|Total of all reporting groups
10824043|NCT00088907|FG000|Participant Flow|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
10824044|NCT00088907|FG001|Participant Flow|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
10824045|NCT00088907|OG000|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
10824046|NCT00088907|OG001|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
10824047|NCT00088907|EG000|Reported Event|Step 1: Docetaxel+Placebo|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule~Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
10824048|NCT00088907|EG001|Reported Event|Step 1: Docetaxel+ZD1839|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.~ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
10824049|NCT00088907|EG002|Reported Event|Step 2: ZD1839|ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
10824050|NCT00088985|BG000|Baseline|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
10824051|NCT00088985|FG000|Participant Flow|Dendritic Cell Vaccine|"Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
10824052|NCT00088985|OG000|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
10824053|NCT00088985|EG000|Reported Event|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
10824054|NCT00089011|BG000|Baseline|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
10824055|NCT00089011|BG001|Baseline|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
10824056|NCT00089011|BG002|Baseline|Total|Total of all reporting groups
10824057|NCT00089011|FG000|Participant Flow|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
10824058|NCT00089011|FG001|Participant Flow|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
10824059|NCT00089011|OG000|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
10824060|NCT00089011|OG001|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
10824061|NCT00089011|EG000|Reported Event|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
10824062|NCT00089011|EG001|Reported Event|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
10824063|NCT00089024|BG000|Baseline|Treatment|"neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma.~Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT."
10824064|NCT00089024|FG000|Participant Flow|Treatment|"neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma.~Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT."
10842565|NCT00248040|FG000|Participant Flow|Reparixin Continuous Infusion|"Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.772 mg/kg/h was administered for12 hours."
10842566|NCT00248040|FG001|Participant Flow|Reparixin Intermittent Infusion|"Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours."
10824065|NCT00089024|OG000|Outcome|Treatment|"Eligible patients will receive an initial two cycles of chemotherapy with: gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU.~Radiation therapy: Patients who required no treatment delays will commence chemoradiation on day 42.~Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. Resection will be performed six to eight weeks after completing chemoradiation.~Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression"
10824066|NCT00089024|EG000|Reported Event|Treatment|"neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma.~Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT."
10824067|NCT00089076|BG000|Baseline|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
10824068|NCT00089076|FG000|Participant Flow|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
10824069|NCT00089076|OG000|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
10824070|NCT00089076|EG000|Reported Event|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
10824071|NCT00089102|BG000|Baseline|Gemcitabine + Irinotecan|"gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle~irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle"
10824072|NCT00089102|FG000|Participant Flow|Gemcitabine + Irinotecan|"gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle~irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle"
10824073|NCT00089102|OG000|Outcome|Gemcitabine + Irinotecan|"gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle~irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle"
10824074|NCT00089102|EG000|Reported Event|Gemcitabine + Irinotecan|"gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle~irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle"
10824075|NCT00089284|BG000|Baseline|Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
10824076|NCT00089284|BG001|Baseline|Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement|In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
10824077|NCT00089284|BG002|Baseline|Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824078|NCT00089284|BG003|Baseline|Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824079|NCT00089284|BG004|Baseline|Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement|After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for </+ 5% Bone Marrow Involvement.
10824080|NCT00089284|BG005|Baseline|Total|Total of all reporting groups
10824081|NCT00089284|FG000|Participant Flow|Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
10824082|NCT00089284|FG001|Participant Flow|Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement|In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
10824083|NCT00089284|FG002|Participant Flow|Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824084|NCT00089284|FG003|Participant Flow|Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824085|NCT00089284|FG004|Participant Flow|Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824086|NCT00089284|FG005|Participant Flow|Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824087|NCT00089284|FG006|Participant Flow|Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement|After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for </+ 5% Bone Marrow Involvement.
10824088|NCT00089284|OG000|Outcome|2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort was open only to those with ≤ 5% of bone marrow involvement.
10824089|NCT00089284|OG001|Outcome|2.5 mg/kg MGd & 6-24% Bone Marrow Involvement|In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to the first cohort on the Lesser Bone Marrow Involvement arm, patients with 6-24% bone marrow involvement could be enrolled to the first cohort in the Greater Bone Marrow Involvement arm.
10824090|NCT00089284|OG002|Outcome|3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|Following completion of enrollment to the first cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the second cohort (3.5 mg/kg MGd).
10824091|NCT00089284|OG003|Outcome|5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement|Following completion of enrollment to the second cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the third cohort (5.0 mg/kg MGd).
10824092|NCT00089284|OG004|Outcome|3.5 mg/kg MGd & 6-24% Bone Marrow Involvement|Following completion of enrollment to their first cohort, patients with 6-24% bone marrow involvement were then enrolled to their second cohort (3.5 mg/kg MGd).
10824093|NCT00089284|OG005|Outcome|5.0 mg/kg MGd & 6-24% Bone Marrow Involvement|Following completion of enrollment to their second cohort, patients with 6-24% bone marrow involvement were then enrolled to their third cohort (5.0 mg/kg MGd).
10824094|NCT00089284|OG000|Outcome|Rituxan and 90Yttrium-Zevalin Plus MGd|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
10824095|NCT00089284|OG000|Outcome|Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
10824096|NCT00089284|OG001|Outcome|Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement|In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
10824097|NCT00089284|OG002|Outcome|Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824098|NCT00089284|OG003|Outcome|Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824099|NCT00089284|OG004|Outcome|Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824100|NCT00089284|OG005|Outcome|Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824101|NCT00089284|OG006|Outcome|Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement|After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for </+ 5% Bone Marrow Involvement.
10824102|NCT00089284|EG000|Reported Event|2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
10824103|NCT00089284|EG001|Reported Event|2.5 mg/kg MGd & 6-24% Bone Marrow Involvement|In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
10824104|NCT00089284|EG002|Reported Event|3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824105|NCT00089284|EG003|Reported Event|5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10824106|NCT00089284|EG004|Reported Event|3.5 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
10824107|NCT00089284|EG005|Reported Event|5.0 mg/kg MGd & 6-24% Bone Marrow Involvement|After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
10842567|NCT00248040|FG002|Participant Flow|Placebo Continuous/Intermittent Infusion|Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
10842568|NCT00248040|OG000|Outcome|Reparixin Continuous Infusion|"Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.772 mg/kg/h was administered for12 hours."
10842569|NCT00248040|OG001|Outcome|Reparixin Intermittent Infusion|"Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours."
10842570|NCT00248040|OG002|Outcome|Placebo Continuous/Intermittent Infusion|Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
10842571|NCT00248040|OG002|Outcome|Placebo Infusion|Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
10842572|NCT00248040|EG000|Reported Event|Reparixin Continuous Infusion|"Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.772 mg/kg/h was administered for12 hours."
10842573|NCT00248040|EG001|Reported Event|Reparixin Intermittent Infusion|"Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.~A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours."
10842574|NCT00248040|EG002|Reported Event|Placebo Continuous/Intermittent Infusion|Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
10842575|NCT00248170|BG000|Baseline|Letrozole|2.5 mg by mouth (p.o.) once daily
10842576|NCT00248170|BG001|Baseline|Anastrozole|1 mg p.o. once daily
10842577|NCT00248170|BG002|Baseline|Total|Total of all reporting groups
10842578|NCT00248170|FG000|Participant Flow|Letrozole|2.5 mg by mouth (p.o.) once daily
10842579|NCT00248170|FG001|Participant Flow|Anastrozole|1 mg p.o. once daily
10842580|NCT00248170|OG000|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
10842581|NCT00248170|OG001|Outcome|Anastrozole|1 mg p.o. once daily
10842582|NCT00248170|EG000|Reported Event|Letrozole|Letrozole
10842583|NCT00248170|EG001|Reported Event|Anastrozole|Anastrozole
10842584|NCT00248495|BG000|Baseline|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
10842585|NCT00248495|FG000|Participant Flow|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
10842586|NCT00248495|OG000|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
10842587|NCT00248495|EG000|Reported Event|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
10842588|NCT00248534|BG000|Baseline|IV Rituximab|"IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.~Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression~rituximab: given IV days 1,8, 15 and 22~methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)~temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles"
10824108|NCT00089297|BG000|Baseline|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
10824109|NCT00089297|FG000|Participant Flow|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
10824110|NCT00089297|OG000|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
10824111|NCT00089297|EG000|Reported Event|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
10824112|NCT00089479|BG000|Baseline|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
10824113|NCT00089479|BG001|Baseline|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
10824114|NCT00089479|BG002|Baseline|Total|Total of all reporting groups
10824115|NCT00089479|FG000|Participant Flow|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
10824116|NCT00089479|FG001|Participant Flow|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
10824117|NCT00089479|OG000|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
10824118|NCT00089479|OG001|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
10824119|NCT00089479|EG000|Reported Event|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
10824120|NCT00089479|EG001|Reported Event|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
10824121|NCT00089505|BG000|Baseline|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
10824122|NCT00089505|BG001|Baseline|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
10824123|NCT00089505|BG002|Baseline|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
10824124|NCT00089505|BG003|Baseline|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
10824125|NCT00089505|BG004|Baseline|Total|Total of all reporting groups
10824126|NCT00089505|FG000|Participant Flow|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
10824127|NCT00089505|FG001|Participant Flow|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
10824128|NCT00089505|FG002|Participant Flow|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
10824129|NCT00089505|FG003|Participant Flow|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
10824130|NCT00089505|OG000|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
10824131|NCT00089505|OG001|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
10824132|NCT00089505|OG002|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
10824133|NCT00089505|OG003|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
10824134|NCT00089505|EG000|Reported Event|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
10824135|NCT00089505|EG001|Reported Event|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
10824136|NCT00089505|EG002|Reported Event|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
10824137|NCT00089505|EG003|Reported Event|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
10824138|NCT00089544|BG000|Baseline|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
10824139|NCT00089544|BG001|Baseline|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
10824140|NCT00089544|BG002|Baseline|Total|Total of all reporting groups
10824141|NCT00089544|FG000|Participant Flow|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
10824142|NCT00089544|FG001|Participant Flow|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
10824143|NCT00089544|OG000|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
10824144|NCT00089544|OG001|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
10824145|NCT00089544|EG000|Reported Event|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
10824146|NCT00089544|EG001|Reported Event|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
10824147|NCT00089583|BG000|Baseline|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
10824148|NCT00089583|BG001|Baseline|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
10824149|NCT00089583|BG002|Baseline|Total|Total of all reporting groups
10824150|NCT00089583|FG000|Participant Flow|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
10824151|NCT00089583|FG001|Participant Flow|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
10824152|NCT00089583|OG000|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
10824153|NCT00089583|OG001|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
10824154|NCT00089583|OG000|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
10824155|NCT00089583|OG001|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
10824156|NCT00089583|OG002|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
10824157|NCT00089583|OG003|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
10824158|NCT00089583|OG002|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
10824159|NCT00089583|OG003|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
10824160|NCT00089583|EG000|Reported Event|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
10824161|NCT00089583|EG001|Reported Event|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
10824162|NCT00089609|BG000|Baseline|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824163|NCT00089609|BG001|Baseline|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
10824164|NCT00089609|BG002|Baseline|Total|Total of all reporting groups
10824165|NCT00089609|FG000|Participant Flow|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824166|NCT00089609|FG001|Participant Flow|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
10824167|NCT00089609|OG000|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824168|NCT00089609|OG000|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
10824169|NCT00089609|OG001|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
10824170|NCT00089609|OG000|Outcome|Main Cohort - Particpants With ≥75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824171|NCT00089609|OG001|Outcome|Main Cohort - Particpants With <75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824172|NCT00089609|EG000|Reported Event|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
10824173|NCT00089609|EG001|Reported Event|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
10824174|NCT00089635|BG000|Baseline|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
10824175|NCT00089635|FG000|Participant Flow|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
10824176|NCT00089635|OG000|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
10824177|NCT00089635|EG000|Reported Event|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
10824178|NCT00089648|BG000|Baseline|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
10824179|NCT00089648|FG000|Participant Flow|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
10824180|NCT00089648|OG000|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
10824181|NCT00089648|EG000|Reported Event|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
10824182|NCT00089661|BG000|Baseline|Denosumab 60 mg Q6M|
10824183|NCT00089661|BG001|Baseline|Placebo|
10824184|NCT00089661|BG002|Baseline|Total|Total of all reporting groups
10824185|NCT00089661|FG000|Participant Flow|Denosumab 60 mg Q6M|
10824186|NCT00089661|FG001|Participant Flow|Placebo|
10824187|NCT00089661|OG000|Outcome|Denosumab 60 mg Q6M|
10824188|NCT00089661|OG001|Outcome|Placebo|
10824189|NCT00089661|EG000|Reported Event|Placebo|
10824190|NCT00089661|EG001|Reported Event|Denosumab 60 mg Q6M|
10824191|NCT00089674|BG000|Baseline|Placebo|Placebo administered subcutaneous every 6 months for 3 years
11312452|NCT03185182|FG000|Participant Flow|Experimental Group|"185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.~Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects"
10824192|NCT00089674|BG001|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
10824193|NCT00089674|BG002|Baseline|Total|Total of all reporting groups
10824194|NCT00089674|FG000|Participant Flow|Placebo|Placebo administered subcutaneous every 6 months for 3 years
10824195|NCT00089674|FG001|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
10824196|NCT00089674|OG000|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
10824197|NCT00089674|OG001|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
10824198|NCT00089674|EG000|Reported Event|Placebo|Placebo administered subcutaneous every 6 months for 3 years
10824199|NCT00089674|EG001|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
10824200|NCT00089752|BG000|Baseline|Active CPAP|CPAP device
10824201|NCT00089752|BG001|Baseline|Sham CPAP|Sham CPAP device
10824202|NCT00089752|BG002|Baseline|Total|Total of all reporting groups
10824203|NCT00089752|FG000|Participant Flow|Active CPAP|Continuous positive pressure device that delivers therapeutic positive airway pressure to maintain airway patency worn continuously for each night of treatment.
10824204|NCT00089752|FG001|Participant Flow|Sham CPAP|A device that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure compared to greater than 5 cm H20 for active treatment. Like active CPAP treatment it is worn every night.
10824205|NCT00089752|OG000|Outcome|Active CPAP|continuous positive airway pressure device
10824206|NCT00089752|OG001|Outcome|Sham CPAP|Sham CPAP device
10824207|NCT00089752|OG000|Outcome|CPAP|Active Continuous Positive Airway Pressure device
10824208|NCT00089752|OG001|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
10824209|NCT00089752|EG000|Reported Event|Active CPAP|Continuous positive pressure device that delivers therapeutic (prescribed > 5 CM H2O) positive airway pressure worn continuously for each night of treatment for 8 wks.
10824210|NCT00089752|EG001|Reported Event|Sham CPAP|A device worn continuously every night that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure for 8 wks.
10824211|NCT00089778|BG000|Baseline|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
10824212|NCT00089778|BG001|Baseline|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
10824213|NCT00089778|BG002|Baseline|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
10824214|NCT00089778|BG003|Baseline|Total|Total of all reporting groups
10824215|NCT00089778|FG000|Participant Flow|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study)."
10824216|NCT00089778|FG001|Participant Flow|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).~This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study)."
10824217|NCT00089778|FG002|Participant Flow|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).~This is not a conventional crossover-If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient's crossing over and there was no impact on study size (too involved for the scope of this study)."
10824218|NCT00089778|OG000|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B)."
10824219|NCT00089778|OG001|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
10824220|NCT00089778|OG000|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
10824221|NCT00089778|OG002|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
10824222|NCT00089778|OG000|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
10824223|NCT00089778|EG000|Reported Event|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
10824224|NCT00089778|EG001|Reported Event|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
10824225|NCT00089778|EG002|Reported Event|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
10824226|NCT00089843|BG000|Baseline|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824227|NCT00089843|BG001|Baseline|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824228|NCT00089843|BG002|Baseline|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
10824229|NCT00089843|BG003|Baseline|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
10824230|NCT00089843|BG004|Baseline|Total|Total of all reporting groups
10824231|NCT00089843|FG000|Participant Flow|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824232|NCT00089843|FG001|Participant Flow|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824233|NCT00089843|FG002|Participant Flow|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
10824234|NCT00089843|FG003|Participant Flow|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
10824235|NCT00089843|OG000|Outcome|Actonel (Risedronate) 35 mg Weekly|Actonel (risedronate) 35 mg, 1 tablet weekly
10824236|NCT00089843|OG001|Outcome|Testosterone|Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
10824237|NCT00089843|OG000|Outcome|Actonel (Risedronate)|Actonel (risedronate) 35 mg tablet weekly
10824238|NCT00089843|OG001|Outcome|Testosterone|Testosterone patch(starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824239|NCT00089843|EG000|Reported Event|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824240|NCT00089843|EG001|Reported Event|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
10824241|NCT00089843|EG002|Reported Event|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
11312453|NCT03185182|OG000|Outcome|Experimental Group|"185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.~Ioflupane I123: 185 MBq ioflupane I123 will be administered at one single occasion to the study subjects"
10824242|NCT00089843|EG003|Reported Event|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
10824243|NCT00089973|BG000|Baseline|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
10824244|NCT00089973|FG000|Participant Flow|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 milligram (mg)/ meter square (m^2). The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
10824245|NCT00089973|OG000|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
10824246|NCT00089973|EG000|Reported Event|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
10824247|NCT00089986|BG000|Baseline|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
10824248|NCT00089986|BG001|Baseline|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
10824249|NCT00089986|BG002|Baseline|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
10824250|NCT00089986|BG003|Baseline|Total|Total of all reporting groups
10824251|NCT00089986|FG000|Participant Flow|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, intravenously (IV) as a loading dose infused over 2 hours (h) followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 milliliters per kilogram per hour (mL/kg/h) for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
10824252|NCT00089986|FG001|Participant Flow|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 milligrams per milliliter (mg/mL) lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 milligram (mg)/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
11312454|NCT03185182|OG000|Outcome|Experimental Group|"185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.~Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects"
10824253|NCT00089986|FG002|Participant Flow|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
10824254|NCT00089986|OG000|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
10824255|NCT00089986|OG001|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
10824256|NCT00089986|OG002|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
10824257|NCT00089986|EG000|Reported Event|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
10824258|NCT00089986|EG001|Reported Event|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
10824259|NCT00089986|EG002|Reported Event|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
10824260|NCT00089999|BG000|Baseline|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824261|NCT00089999|BG001|Baseline|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824262|NCT00089999|BG002|Baseline|Total|Total of all reporting groups
10824263|NCT00089999|FG000|Participant Flow|Lapatinib 1500 mg QD|Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824264|NCT00089999|FG001|Participant Flow|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824265|NCT00089999|OG000|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824266|NCT00089999|OG001|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824267|NCT00089999|OG000|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824268|NCT00089999|EG000|Reported Event|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824269|NCT00089999|EG001|Reported Event|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
10824270|NCT00090051|BG000|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10824271|NCT00090051|BG001|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
10824272|NCT00090051|BG002|Baseline|Total|Total of all reporting groups
10824273|NCT00090051|FG000|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10824274|NCT00090051|FG001|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
10824275|NCT00090051|OG000|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10824276|NCT00090051|OG001|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
10824277|NCT00090051|EG000|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
10824278|NCT00090051|EG001|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
10824279|NCT00090064|BG000|Baseline|MDMA-assisted Therapy|Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
10824280|NCT00090064|BG001|Baseline|Placebo With Therapy|Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
10824281|NCT00090064|BG002|Baseline|Total|Total of all reporting groups
10824282|NCT00090064|FG000|Participant Flow|MDMA-assisted Therapy|Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
10824283|NCT00090064|FG001|Participant Flow|Placebo With Therapy|Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
10824284|NCT00090064|OG000|Outcome|MDMA-assisted Therapy|Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
10824285|NCT00090064|OG001|Outcome|Placebo With Therapy|Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
10824286|NCT00090064|OG000|Outcome|MDMA-assisted Therapy|"Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions.~3,4-methylenedioxymethamphetamine: 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA~Therapy: Non-directive therapy provided by a team of two co-therapists"
10824287|NCT00090064|OG001|Outcome|Placebo With Therapy|"Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.~Lactose placebo pill: 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo~Therapy: Non-directive therapy provided by a team of two co-therapists"
10824288|NCT00090064|EG000|Reported Event|MDMA-assisted Therapy (Stage 1)|Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
10824289|NCT00090064|EG001|Reported Event|Placebo With Therapy (Stage 1)|Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
10824290|NCT00090064|EG002|Reported Event|MDMA-assisted Therapy (Stage 2)|Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
10824291|NCT00090103|BG000|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
10824292|NCT00090103|BG001|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
10824293|NCT00090103|BG002|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
10824294|NCT00090103|BG003|Baseline|Total|Total of all reporting groups
10824295|NCT00090103|FG000|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
10824296|NCT00090103|FG001|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
10824297|NCT00090103|FG002|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
10824298|NCT00090103|OG000|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
10824299|NCT00090103|OG001|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
10824300|NCT00090103|OG002|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
10824301|NCT00090103|EG000|Reported Event|Combination|
10824302|NCT00090103|EG001|Reported Event|Dutasteride 0.5 mg|
10824303|NCT00090103|EG002|Reported Event|Tamsulosin 0.4 mg|
10824304|NCT00090220|BG000|Baseline|qHPV Vaccine in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824305|NCT00090220|BG001|Baseline|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
10824306|NCT00090220|BG002|Baseline|Total|Total of all reporting groups
10824307|NCT00090220|FG000|Participant Flow|qHPV Vaccine in Base Study|Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
10824308|NCT00090220|FG001|Participant Flow|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6
10824309|NCT00090220|FG002|Participant Flow|Placebo in Base Study: EXT1|Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
10824310|NCT00090220|FG003|Participant Flow|Incomplete qHPV Regimen in Base Study: EXT1|Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
10824311|NCT00090220|FG004|Participant Flow|qHPV Vaccine in Base Study: LTFU (EXT2)|Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
10824312|NCT00090220|FG005|Participant Flow|Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)|Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
10824313|NCT00090220|OG000|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824314|NCT00090220|OG001|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
10824315|NCT00090220|OG001|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
10824316|NCT00090220|OG001|Outcome|Placebo in Base Study|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
10824317|NCT00090220|OG000|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824318|NCT00090220|OG001|Outcome|Base Study: Placebo|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
10824319|NCT00090220|OG001|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824320|NCT00090220|OG002|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824321|NCT00090220|OG000|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824322|NCT00090220|OG001|Outcome|qHPV in Base Study: Participants 24 to 35 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
10824323|NCT00090220|OG001|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
10824324|NCT00090220|EG000|Reported Event|qHPV Vaccine: Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
10824325|NCT00090220|EG001|Reported Event|Placebo: Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
10824326|NCT00090220|EG002|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67
10824327|NCT00090220|EG003|Reported Event|Long-term Follow-up: EXT2|Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
10824328|NCT00090233|BG000|Baseline|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
10824329|NCT00090233|BG001|Baseline|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
10824330|NCT00090233|BG002|Baseline|Total|Total of all reporting groups
10824331|NCT00090233|FG000|Participant Flow|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
10824332|NCT00090233|FG001|Participant Flow|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
10824333|NCT00090233|OG000|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
10824334|NCT00090233|OG001|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
10824335|NCT00090233|OG000|Outcome|RotaTeq™|Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
10824336|NCT00090233|OG001|Outcome|Placebo|Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
10824337|NCT00090233|OG000|Outcome|RotaTeq™|The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
10824338|NCT00090233|OG001|Outcome|Placebo|The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
10824339|NCT00090233|EG000|Reported Event|RotaTeq™|"Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
10824340|NCT00090233|EG001|Reported Event|Placebo|"Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
10824341|NCT00090285|BG000|Baseline|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824342|NCT00090285|BG001|Baseline|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824343|NCT00090285|BG002|Baseline|Total|Total of all reporting groups
10824344|NCT00090285|FG000|Participant Flow|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824345|NCT00090285|FG001|Participant Flow|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824346|NCT00090285|FG002|Participant Flow|EXT1: Placebo in Base Study|"Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.~Participants were followed to EXT1 Month 7."
10824347|NCT00090285|FG003|Participant Flow|EXT1: Incomplete qHPV Regimen in Base Study|"Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).~Participants were followed to EXT1 Month 7."
10824348|NCT00090285|FG004|Participant Flow|LTFU (EXT2): Early Vaccination Group|Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
10824349|NCT00090285|FG005|Participant Flow|LTFU (EXT2): Catch-up Vaccination Group|Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
10824350|NCT00090285|OG000|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824351|NCT00090285|OG001|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824352|NCT00090285|OG000|Outcome|qHPV Vaccine in Base Study|The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
10824353|NCT00090285|OG000|Outcome|MSM qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
10824354|NCT00090285|OG000|Outcome|qHPV Vaccine: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
10824355|NCT00090285|OG001|Outcome|Placebo: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
10824356|NCT00090285|OG000|Outcome|LTFU (EXT2): Early Vaccination Group|Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
10824357|NCT00090285|OG001|Outcome|LTFU (EXT2): Catch-up Vaccination Group|Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
10824358|NCT00090285|OG000|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
10824359|NCT00090285|EG000|Reported Event|qHPV Vaccine: Base Study|The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
10824360|NCT00090285|EG001|Reported Event|Placebo: Base Study|The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
10824361|NCT00090285|EG002|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
10824362|NCT00090285|EG003|Reported Event|LTFU (EXT2)|Participants received ≥1 dose of qHPV vaccine in Base Study, or received placebo in Base Study and qHPV vaccine in EXT1. This arm includes both groups enrolled in LTFU (EXT2): Early Vaccination Group and Catch-up Vaccination Group.
10824363|NCT00090363|BG000|Baseline|Placebo|Matching placebo oral tablet once daily, with best supportive care
10824364|NCT00090363|BG001|Baseline|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
10824365|NCT00090363|BG002|Baseline|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
10824366|NCT00090363|BG003|Baseline|Total|Total of all reporting groups
10824367|NCT00090363|FG000|Participant Flow|Placebo|Matching placebo oral tablet once daily, with best supportive care
10824368|NCT00090363|FG001|Participant Flow|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
10824369|NCT00090363|FG002|Participant Flow|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
10824370|NCT00090363|OG000|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
10824371|NCT00090363|OG001|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
10824372|NCT00090363|OG002|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
10824373|NCT00090363|EG000|Reported Event|Placebo|Matching placebo oral tablet once daily, with best supportive care
10824374|NCT00090363|EG001|Reported Event|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
10824375|NCT00090363|EG002|Reported Event|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
10824376|NCT00090402|BG000|Baseline|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
10824377|NCT00090402|BG001|Baseline|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
10824378|NCT00090402|BG002|Baseline|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
10824379|NCT00090402|BG003|Baseline|Total|Total of all reporting groups
10824380|NCT00090402|FG000|Participant Flow|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
10824381|NCT00090402|FG001|Participant Flow|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
10824382|NCT00090402|FG002|Participant Flow|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
10824383|NCT00090402|OG000|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
10824384|NCT00090402|OG001|Outcome|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
10824385|NCT00090402|OG002|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
10824386|NCT00090402|OG000|Outcome|Placebo|"Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.~Placebo: Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months."
10824387|NCT00090402|OG001|Outcome|Fish Oil|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.~Fish Oil: Fish oil concentrate (daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) taken for 12 months."
11312455|NCT03185182|EG000|Reported Event|Experimental Group|"185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.~Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects"
11312456|NCT03185455|BG000|Baseline|Standard of Care|Women randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. The date and time of the office appointment is specified in the discharge document and reviewed with the patient prior to discharge. Care at this visit is based on a physician derived algorithm.
11312457|NCT03185455|BG001|Baseline|Remote (Text Based) Surveillance|"Women randomized to the text-based surveillance arm will be given an automatic Omron© blood pressure cuff and instructed on use by research team members prior to discharge. Patients will be enrolled into the texting program platform developed through Way to Health. A starting introductory text message is sent by the Way to Health platform to the phone number provided on day of discharge. Patients receive reminders to text message their blood pressures twice daily for two weeks postpartum, starting on the day after discharge. Immediate feedback is provided to the patient based on a preprogrammed automated algorithm. The primary investigator is alerted with pre-specified severe range blood pressure values (systolic blood pressure > 160 mmHg or diastolic > 100 mmHg) via text message or email and care is escalated as needed based on the same outpatient algorithm used in the office.~Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to"
11312458|NCT03185455|BG002|Baseline|Total|Total of all reporting groups
11312459|NCT03185455|FG000|Participant Flow|Standard of Care|Women randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. The date and time of the office appointment is specified in the discharge document and reviewed with the patient prior to discharge. Care at this visit is based on a physician derived algorithm.
11312460|NCT03185455|FG001|Participant Flow|Remote (Text Based) Surveillance|"Women randomized to the text-based surveillance arm will be given an automatic Omron© blood pressure cuff and instructed on use by research team members prior to discharge. Patients will be enrolled into the texting program platform developed through Way to Health. A starting introductory text message is sent by the Way to Health platform to the phone number provided on day of discharge. Patients receive reminders to text message their blood pressures twice daily for two weeks postpartum, starting on the day after discharge. Immediate feedback is provided to the patient based on a preprogrammed automated algorithm. The primary investigator is alerted with pre-specified severe range blood pressure values (systolic blood pressure > 160 mmHg or diastolic > 100 mmHg) via text message or email and care is escalated as needed based on the same outpatient algorithm used in the office.~Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to"
11312461|NCT03185455|OG000|Outcome|Standard of Care|Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
11312462|NCT03185455|OG001|Outcome|Remote (Text Based) Surveillance|Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
11312463|NCT03185455|EG000|Reported Event|Standard of Care|Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
11312464|NCT03185455|EG001|Reported Event|Remote (Text Based) Surveillance|Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
11312465|NCT03185481|BG000|Baseline|PF-06649751 15 mg|Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.
11312466|NCT03185481|FG000|Participant Flow|PF-06649751 15 mg|Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.
11312467|NCT03185481|OG000|Outcome|PF-06649751 15 mg|Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.
11312468|NCT03185481|EG000|Reported Event|PF-06649751 15 mg|Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.
11312469|NCT03185546|BG000|Baseline|NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312470|NCT03185546|BG001|Baseline|VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312471|NCT03185546|BG002|Baseline|VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312472|NCT03185546|BG003|Baseline|VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312473|NCT03185546|BG004|Baseline|NNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312474|NCT03185546|BG005|Baseline|NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312475|NCT03185546|BG006|Baseline|NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312476|NCT03185546|BG007|Baseline|VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312477|NCT03185546|BG008|Baseline|Total|Total of all reporting groups
11312478|NCT03185546|FG000|Participant Flow|Normal Nicotine Content (NNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312479|NCT03185546|FG001|Participant Flow|NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312480|NCT03185546|FG002|Participant Flow|NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11333306|NCT03511937|BG000|Baseline|Sugar-Sweetened Beverage Health Warning Label|Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
10824388|NCT00090402|OG002|Outcome|Fish Oil and Lipoic Acid|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).~Fish Oil and Lipoic acid: Fish oil concentrate(daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) plus lipoic acid (daily dose 600 milligrams)taken for 12 months"
10824389|NCT00090402|EG000|Reported Event|Placebo|Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate
10824390|NCT00090402|EG001|Reported Event|Fish Oil|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
10824391|NCT00090402|EG002|Reported Event|Fish Oil Plus Lipoic Acid|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
10824392|NCT00090493|BG000|Baseline|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.
10824393|NCT00090493|FG000|Participant Flow|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
10824394|NCT00090493|OG000|Outcome|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
10824395|NCT00090493|EG000|Reported Event|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
10824396|NCT00090519|BG000|Baseline|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
10824397|NCT00090519|BG001|Baseline|Placebo|QD oral for up to 36 months
10824398|NCT00090519|BG002|Baseline|Total|Total of all reporting groups
10824399|NCT00090519|FG000|Participant Flow|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
10824400|NCT00090519|FG001|Participant Flow|Placebo|QD oral for up to 36 months
10824401|NCT00090519|OG000|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
10824402|NCT00090519|OG001|Outcome|Placebo|QD oral for up to 36 months
10824403|NCT00090519|EG000|Reported Event|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
10824404|NCT00090519|EG001|Reported Event|Placebo|QD oral for up to 36 months
10824405|NCT00090545|BG000|Baseline|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824406|NCT00090545|BG001|Baseline|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles"
10824407|NCT00090545|BG002|Baseline|Total|Total of all reporting groups
10824408|NCT00090545|FG000|Participant Flow|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824409|NCT00090545|FG001|Participant Flow|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
11333307|NCT03511937|BG001|Baseline|Neutral Label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
10824410|NCT00090545|OG000|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824411|NCT00090545|OG001|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
11333308|NCT03511937|BG002|Baseline|Total|Total of all reporting groups
10824412|NCT00090545|OG000|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824413|NCT00090545|OG001|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824414|NCT00090545|EG000|Reported Event|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824415|NCT00090545|EG001|Reported Event|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
10824416|NCT00090584|BG000|Baseline|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
10824417|NCT00090584|BG001|Baseline|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
10824418|NCT00090584|BG002|Baseline|Total|Total of all reporting groups
10824419|NCT00090584|FG000|Participant Flow|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
10824420|NCT00090584|FG001|Participant Flow|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
10824421|NCT00090584|OG000|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
10824422|NCT00090584|OG001|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
10824423|NCT00090584|OG000|Outcome|Combination at Baseline|Baseline value for women in combination therapy
10824424|NCT00090584|OG001|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
10824425|NCT00090584|OG002|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
10824426|NCT00090584|OG003|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
10824427|NCT00090584|OG004|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
10824428|NCT00090584|OG005|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
10824429|NCT00090584|OG000|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
10824430|NCT00090584|OG001|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
10824431|NCT00090584|EG000|Reported Event|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
10824432|NCT00090584|EG001|Reported Event|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
10824433|NCT00090610|BG000|Baseline|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
10824434|NCT00090610|BG001|Baseline|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
10824435|NCT00090610|BG002|Baseline|Total|Total of all reporting groups
10824436|NCT00090610|FG000|Participant Flow|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
10824437|NCT00090610|FG001|Participant Flow|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
10824438|NCT00090610|OG000|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
10824439|NCT00090610|OG001|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
10824440|NCT00090610|EG000|Reported Event|Arm 1|Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first).
10824441|NCT00090610|EG001|Reported Event|Arm2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
10824442|NCT00090753|BG000|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
10824443|NCT00090753|BG001|Baseline|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
10824444|NCT00090753|BG002|Baseline|Total|Total of all reporting groups
10842589|NCT00248534|FG000|Participant Flow|IV Rituximab|"IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.~Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression~rituximab: given IV days 1,8, 15 and 22~methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)~temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles"
10824445|NCT00090753|FG000|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
10824446|NCT00090753|FG001|Participant Flow|Comparator ESA|Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
10824447|NCT00090753|OG000|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
10824448|NCT00090753|OG001|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
10824449|NCT00090753|EG000|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
10824450|NCT00090753|EG001|Reported Event|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
10824451|NCT00090766|BG000|Baseline|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824452|NCT00090766|BG001|Baseline|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824453|NCT00090766|BG002|Baseline|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824454|NCT00090766|BG003|Baseline|Total|Total of all reporting groups
10824455|NCT00090766|FG000|Participant Flow|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
10824456|NCT00090766|FG001|Participant Flow|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824457|NCT00090766|FG002|Participant Flow|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824458|NCT00090766|OG000|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824459|NCT00090766|OG001|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824460|NCT00090766|OG002|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824461|NCT00090766|OG002|Outcome|Valganciclovir Age Group >= 12 Years|Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
10824462|NCT00090766|OG000|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824463|NCT00090766|EG000|Reported Event|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824464|NCT00090766|EG001|Reported Event|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824465|NCT00090766|EG002|Reported Event|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
10824466|NCT00090779|BG000|Baseline|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
10824467|NCT00090779|BG001|Baseline|DT Arm|DT arm participants received no Treatment
10824468|NCT00090779|BG002|Baseline|Total|Total of all reporting groups
10824469|NCT00090779|FG000|Participant Flow|IT Arm|On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
10824470|NCT00090779|FG001|Participant Flow|DT Arm|On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
10824471|NCT00090779|OG000|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
10824472|NCT00090779|OG001|Outcome|DT Arm|DT arm participants received no Treatment
10824473|NCT00090779|EG000|Reported Event|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
10824474|NCT00090779|EG001|Reported Event|DT Arm|DT arm participants received no Treatment
10824475|NCT00090844|BG000|Baseline|Triptorelin|GnRH analogue (triptorelin) during chemotherapy
10824476|NCT00090844|BG001|Baseline|no Triptorelin|no GnRH analogue (triptorelin) during chemotherapy
10824477|NCT00090844|BG002|Baseline|Total|Total of all reporting groups
10824478|NCT00090844|FG000|Participant Flow|Triptorelin|"Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
10824479|NCT00090844|FG001|Participant Flow|no Triptorelin|No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
10824480|NCT00090844|OG000|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
10824481|NCT00090844|OG001|Outcome|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
10824482|NCT00090844|OG000|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
10824483|NCT00090844|EG000|Reported Event|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
10824484|NCT00090844|EG001|Reported Event|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
10824485|NCT00090857|BG000|Baseline|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824486|NCT00090857|BG001|Baseline|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824487|NCT00090857|BG002|Baseline|Total|Total of all reporting groups
10824488|NCT00090857|FG000|Participant Flow|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824489|NCT00090857|FG001|Participant Flow|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824490|NCT00090857|OG000|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
11312481|NCT03185546|FG003|Participant Flow|NNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312482|NCT03185546|FG004|Participant Flow|Very Low Nicotine Content (VLNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312483|NCT03185546|FG005|Participant Flow|VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312484|NCT03185546|FG006|Participant Flow|VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312485|NCT03185546|FG007|Participant Flow|VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312486|NCT03185546|OG000|Outcome|NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312487|NCT03185546|OG001|Outcome|VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312488|NCT03185546|OG002|Outcome|VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312489|NCT03185546|OG003|Outcome|VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312490|NCT03185546|OG004|Outcome|NNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312491|NCT03185546|OG005|Outcome|NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
10824491|NCT00090857|OG001|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824492|NCT00090857|EG000|Reported Event|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824493|NCT00090857|EG001|Reported Event|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
10824494|NCT00090987|BG000|Baseline|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
10824495|NCT00090987|FG000|Participant Flow|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
10824496|NCT00090987|OG000|Outcome|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
10824497|NCT00090987|EG000|Reported Event|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
10824498|NCT00091026|BG000|Baseline|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
10824499|NCT00091026|BG001|Baseline|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
10824500|NCT00091026|BG002|Baseline|Total|Total of all reporting groups
10824501|NCT00091026|FG000|Participant Flow|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
10824502|NCT00091026|FG001|Participant Flow|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
10824503|NCT00091026|OG000|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
10824504|NCT00091026|OG001|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
10824505|NCT00091026|EG000|Reported Event|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
10824506|NCT00091026|EG001|Reported Event|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
10824507|NCT00091169|BG000|Baseline|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
10824508|NCT00091169|BG001|Baseline|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
10824509|NCT00091169|BG002|Baseline|Total|Total of all reporting groups
10824510|NCT00091169|FG000|Participant Flow|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
10824511|NCT00091169|FG001|Participant Flow|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
10824512|NCT00091169|OG000|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
10824513|NCT00091169|OG001|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
10824514|NCT00091169|OG000|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
10824515|NCT00091169|OG001|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
10824516|NCT00091169|EG000|Reported Event|Levocarnitine|Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally
10824517|NCT00091169|EG001|Reported Event|Placebo|Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
10824518|NCT00091260|BG000|Baseline|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
10824519|NCT00091260|FG000|Participant Flow|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
10824520|NCT00091260|OG000|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
10824521|NCT00091260|OG000|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
10824522|NCT00091260|EG000|Reported Event|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
10824523|NCT00091273|BG000|Baseline|Single Arm|
10824524|NCT00091273|FG000|Participant Flow|Single Arm|
10824525|NCT00091273|OG000|Outcome|Single Arm|
10824526|NCT00091273|EG000|Reported Event|Single Arm|
10824527|NCT00091390|BG000|Baseline|External Beam Radiotherapy and High Dose Brachytherapy Boost|"High Dose brachytherapy boost: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.~External beam radiotherapy: 45 Gy as 1.8 Gy five days a week for five weeks."
10824528|NCT00091390|FG000|Participant Flow|External Beam Radiotherapy and High Dose Brachytherapy Boost|"High Dose brachytherapy boost: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.~External beam radiotherapy: 45 Gy as 1.8 Gy five days a week for five weeks."
10824529|NCT00091390|OG000|Outcome|External Beam Radiotherapy and High Dose Brachytherapy Boost|"High Dose brachytherapy boost: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.~External beam radiotherapy: 45 Gy as 1.8 Gy five days a week for five weeks."
10824530|NCT00091390|EG000|Reported Event|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
10824531|NCT00091442|BG000|Baseline|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824532|NCT00091442|BG001|Baseline|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824533|NCT00091442|BG002|Baseline|Total|Total of all reporting groups
10824534|NCT00091442|FG000|Participant Flow|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824535|NCT00091442|FG001|Participant Flow|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824536|NCT00091442|OG000|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824537|NCT00091442|OG001|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824538|NCT00091442|EG000|Reported Event|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824539|NCT00091442|EG001|Reported Event|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
10824540|NCT00091507|BG000|Baseline|GIK --|GIK = glucose-insulin-potassium
10824541|NCT00091507|BG001|Baseline|Placebo|Dextrose 5%
10824542|NCT00091507|BG002|Baseline|Total|Total of all reporting groups
10824543|NCT00091507|FG000|Participant Flow|GIK --|GIK = glucose-insulin-potassium
10824544|NCT00091507|FG001|Participant Flow|Placebo|Dextrose 5%
10824545|NCT00091507|OG000|Outcome|GIK --|GIK = glucose-insulin-potassium
10824546|NCT00091507|OG001|Outcome|Placebo|Dextrose 5%
10824547|NCT00091507|EG000|Reported Event|GIK --|GIK = glucose-insulin-potassium
10824548|NCT00091507|EG001|Reported Event|Placebo|Dextrose 5%
10824549|NCT00091572|BG000|Baseline|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
10824550|NCT00091572|BG001|Baseline|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
10824551|NCT00091572|BG002|Baseline|Total|Total of all reporting groups
10824552|NCT00091572|FG000|Participant Flow|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
10824553|NCT00091572|FG001|Participant Flow|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
10824554|NCT00091572|OG000|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
10824555|NCT00091572|OG001|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
10824556|NCT00091572|EG000|Reported Event|Temozolomide|
10824557|NCT00091572|EG001|Reported Event|Dacarbazine|
10824558|NCT00091793|BG000|Baseline|Denosumab 60 mg Q6M|
10824559|NCT00091793|BG001|Baseline|Placebo|
10824560|NCT00091793|BG002|Baseline|Total|Total of all reporting groups
10824561|NCT00091793|FG000|Participant Flow|Denosumab 60 mg Q6M|
10824562|NCT00091793|FG001|Participant Flow|Placebo|
10824563|NCT00091793|OG000|Outcome|Denosumab 60 mg Q6M|
10824564|NCT00091793|OG001|Outcome|Placebo|
10824565|NCT00091793|EG000|Reported Event|Placebo|
10824566|NCT00091793|EG001|Reported Event|Denosumab 60 mg Q6M|
10824567|NCT00091819|BG000|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
10824568|NCT00091819|BG001|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
10824569|NCT00091819|BG002|Baseline|Total|Total of all reporting groups
10824570|NCT00091819|FG000|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
10824571|NCT00091819|FG001|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
10824572|NCT00091819|OG000|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
10824573|NCT00091819|OG001|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
10824574|NCT00091819|EG000|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
10824575|NCT00091819|EG001|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
10824576|NCT00091832|BG000|Baseline|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
10824577|NCT00091832|BG001|Baseline|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
10824578|NCT00091832|BG002|Baseline|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
10824579|NCT00091832|BG003|Baseline|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
10824580|NCT00091832|BG004|Baseline|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
10824581|NCT00091832|BG005|Baseline|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
10824582|NCT00091832|BG006|Baseline|Total|Total of all reporting groups
10824583|NCT00091832|FG000|Participant Flow|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)
10824584|NCT00091832|FG001|Participant Flow|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
10824585|NCT00091832|FG002|Participant Flow|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
10824586|NCT00091832|FG003|Participant Flow|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
10824587|NCT00091832|FG004|Participant Flow|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
10824588|NCT00091832|FG005|Participant Flow|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
10824589|NCT00091832|OG000|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
10824590|NCT00091832|OG001|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
10824591|NCT00091832|OG002|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
10824592|NCT00091832|OG003|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
10824593|NCT00091832|OG004|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
10824594|NCT00091832|OG005|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
10824595|NCT00091832|EG000|Reported Event|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.
10824596|NCT00091832|EG001|Reported Event|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
10824597|NCT00091832|EG002|Reported Event|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
10824598|NCT00091832|EG003|Reported Event|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
10824599|NCT00091832|EG004|Reported Event|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
10824600|NCT00091832|EG005|Reported Event|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
10824601|NCT00091949|BG000|Baseline|Pioglitazone|pioglitazone: a thiazolidinedione drug
10824602|NCT00091949|BG001|Baseline|Placebo|placebo: an inactive substance
10824603|NCT00091949|BG002|Baseline|Total|Total of all reporting groups
10824604|NCT00091949|FG000|Participant Flow|Pioglitazone|pioglitazone: a thiazolidinedione drug
10824605|NCT00091949|FG001|Participant Flow|Placebo|placebo: an inactive substance
10824606|NCT00091949|OG000|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
10824607|NCT00091949|OG001|Outcome|Placebo|placebo: an inactive substance
10824608|NCT00091949|EG000|Reported Event|Pioglitazone|pioglitazone: a thiazolidinedione drug
10824609|NCT00091949|EG001|Reported Event|Placebo|placebo: an inactive substance
10824610|NCT00091962|BG000|Baseline|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
10824611|NCT00091962|BG001|Baseline|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
10824612|NCT00091962|BG002|Baseline|Non-Depressed Control|Observational only
10824613|NCT00091962|BG003|Baseline|Total|Total of all reporting groups
10824614|NCT00091962|FG000|Participant Flow|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
10824615|NCT00091962|FG001|Participant Flow|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
10824616|NCT00091962|FG002|Participant Flow|Non-Depressed Control Group|
10824617|NCT00091962|OG000|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
10824618|NCT00091962|OG001|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
10824619|NCT00091962|OG002|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
11312492|NCT03185546|OG006|Outcome|NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312493|NCT03185546|OG007|Outcome|VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312494|NCT03185546|EG000|Reported Event|NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312495|NCT03185546|EG001|Reported Event|VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312496|NCT03185546|EG002|Reported Event|VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312497|NCT03185546|EG003|Reported Event|VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor|"Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312498|NCT03185546|EG004|Reported Event|NNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312499|NCT03185546|EG005|Reported Event|NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312500|NCT03185546|EG006|Reported Event|NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors|"Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.~NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors"
11312501|NCT03185546|EG007|Reported Event|VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors|"Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors~VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks~Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks~Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices"
11312502|NCT03185546|EG008|Reported Event|Pre-Randomization|Participants signed consent but screen failed before randomizing into study
10824620|NCT00091962|OG000|Outcome|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
10824621|NCT00091962|OG001|Outcome|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
10824622|NCT00091962|OG002|Outcome|Non-Depressed Control Group|Non-depressed groups as Control to see the natural course of recovery after CABG
10824623|NCT00091962|EG000|Reported Event|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
10824624|NCT00091962|EG001|Reported Event|Depressed Usual Care|"Usual care for depression by patients' PCP"
10824625|NCT00091962|EG002|Reported Event|Non-Depressed Control|Non-depressed control group with no intervention
10824626|NCT00092417|BG000|Baseline|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
10824627|NCT00092417|BG001|Baseline|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
10824628|NCT00092417|BG002|Baseline|Total|Total of all reporting groups
10824629|NCT00092417|FG000|Participant Flow|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
10824630|NCT00092417|FG001|Participant Flow|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
10824631|NCT00092417|OG000|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
10824632|NCT00092417|OG001|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
10824633|NCT00092417|EG000|Reported Event|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
10824634|NCT00092417|EG001|Reported Event|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
10824635|NCT00092443|BG000|Baseline|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824636|NCT00092443|BG001|Baseline|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824637|NCT00092443|BG002|Baseline|Total|Total of all reporting groups
10824638|NCT00092443|FG000|Participant Flow|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824639|NCT00092443|FG001|Participant Flow|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824640|NCT00092443|OG000|Outcome|RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824641|NCT00092443|OG001|Outcome|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
10824642|NCT00092443|OG000|Outcome|RotaTeq™ at Expiry Potency (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824643|NCT00092443|OG001|Outcome|RotaTeq™ at Expiry Potency (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824644|NCT00092443|OG002|Outcome|RotaTeq™ at Expiry Potency (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824645|NCT00092443|OG003|Outcome|RotaTeq™ at Expiry Potency (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824646|NCT00092443|OG004|Outcome|RotaTeq™ at Expiry Potency (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824647|NCT00092443|OG005|Outcome|Placebo Matching RotaTeq™ (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824648|NCT00092443|OG006|Outcome|Placebo Matching RotaTeq™ (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824649|NCT00092443|OG007|Outcome|Placebo Matching RotaTeq™ (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824650|NCT00092443|OG008|Outcome|Placebo Matching RotaTeq™ (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824651|NCT00092443|OG009|Outcome|Placebo Matching RotaTeq™ (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
10824652|NCT00092443|EG000|Reported Event|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
10824653|NCT00092443|EG001|Reported Event|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
10824654|NCT00092456|BG000|Baseline|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824655|NCT00092456|BG001|Baseline|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824656|NCT00092456|BG002|Baseline|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824657|NCT00092456|BG003|Baseline|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824658|NCT00092456|BG004|Baseline|Total|Total of all reporting groups
10824659|NCT00092456|FG000|Participant Flow|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824660|NCT00092456|FG001|Participant Flow|RotaTeq™ Lot 2|Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824661|NCT00092456|FG002|Participant Flow|RotaTeq™ Lot 3|Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824662|NCT00092456|FG003|Participant Flow|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
10824663|NCT00092456|OG000|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824664|NCT00092456|OG001|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824665|NCT00092456|OG002|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824666|NCT00092456|OG003|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824667|NCT00092456|EG000|Reported Event|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824668|NCT00092456|EG001|Reported Event|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824669|NCT00092456|EG002|Reported Event|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824670|NCT00092456|EG003|Reported Event|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
10824671|NCT00092495|BG000|Baseline|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824672|NCT00092495|BG001|Baseline|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824673|NCT00092495|BG002|Baseline|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
10824674|NCT00092495|BG003|Baseline|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824675|NCT00092495|BG004|Baseline|Total|Total of all reporting groups
10824676|NCT00092495|FG000|Participant Flow|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824677|NCT00092495|FG001|Participant Flow|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824678|NCT00092495|FG002|Participant Flow|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
10824679|NCT00092495|FG003|Participant Flow|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824680|NCT00092495|FG004|Participant Flow|Extension Study|"Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as Completed Period are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
10824681|NCT00092495|OG000|Outcome|Girls 10-15 Years|
10824682|NCT00092495|OG001|Outcome|Boys 10-15 Years|
10824683|NCT00092495|OG002|Outcome|Women 16-23 Years|
10824684|NCT00092495|OG000|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824685|NCT00092495|OG001|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824686|NCT00092495|OG002|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
10824687|NCT00092495|OG003|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
10824688|NCT00092495|EG000|Reported Event|20% Formulation|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824689|NCT00092495|EG001|Reported Event|40% Formulation|Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824690|NCT00092495|EG002|Reported Event|60% Formulation|Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824691|NCT00092495|EG003|Reported Event|100% Formulation|Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
10824692|NCT00092521|BG000|Baseline|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824693|NCT00092521|BG001|Baseline|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824694|NCT00092521|BG002|Baseline|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824695|NCT00092521|BG003|Baseline|Total|Total of all reporting groups
10824696|NCT00092521|FG000|Participant Flow|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824697|NCT00092521|FG001|Participant Flow|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."
10824698|NCT00092521|FG002|Participant Flow|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824699|NCT00092521|FG003|Participant Flow|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
10824700|NCT00092521|OG000|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824701|NCT00092521|OG001|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824702|NCT00092521|EG000|Reported Event|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824703|NCT00092521|EG001|Reported Event|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824704|NCT00092521|EG002|Reported Event|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
10824705|NCT00092521|EG003|Reported Event|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
10824706|NCT00092534|BG000|Baseline|Base Study Group 1: qHPV Vaccine|During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824707|NCT00092534|BG001|Baseline|Base Study Group 2: Placebo|During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824708|NCT00092534|BG002|Baseline|Total|Total of all reporting groups
10824709|NCT00092534|FG000|Participant Flow|Base Study Group 1: qHPV Vaccine|During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824710|NCT00092534|FG001|Participant Flow|Base Study Group 2: Placebo|During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824711|NCT00092534|FG002|Participant Flow|Base Study EXT|"Participants who received placebo (N=581) or an incomplete qHPV vaccine regimen (N=13) were enrolled to receive qHPV vaccine during the base study extension; participants designated as Not Completed are those who did not complete all three vaccinations and/or all required follow-up visits."
10824712|NCT00092534|FG003|Participant Flow|LTFU: Cohort 1|Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.
10824713|NCT00092534|FG004|Participant Flow|LTFU: Cohort 2|Participants who received placebo in the Base Study and qHPV vaccine after completion of the Base Study and prior to entry into the LTFU. Cohort 2 provided a total of approximately 10 years of follow-up post-vaccination.
10824714|NCT00092534|OG000|Outcome|Base Study Group 1: qHPV Vaccine|During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824715|NCT00092534|OG001|Outcome|Base Study Group 2: Placebo|During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.
10824716|NCT00092534|OG000|Outcome|LTFU: Cohort 1|Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.
10824717|NCT00092534|EG000|Reported Event|Base Study Group 1: qHPV Vaccine|During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) during the Vaccination Period and were followed for up to 4 years during the Base Study Follow-Up.
10824718|NCT00092534|EG001|Reported Event|Base Study Group 2: Placebo|Participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) during the Base Study Vaccination Period, and then received 3 qHPV vaccinations during the 4-year Base Study EXT.
11312503|NCT03186261|BG000|Baseline|Nano Silver Fluoride Solution|"Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.~Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties."
11312504|NCT03186261|BG001|Baseline|Cavity Cleanser|"Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.~Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush."
11312505|NCT03186261|BG002|Baseline|Total|Total of all reporting groups
11312506|NCT03186261|FG000|Participant Flow|Nano Silver Fluoride Solution|"Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.~Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties."
10824719|NCT00092534|EG002|Reported Event|Base Study EXT|"Participants who received placebo (N=581) or an incomplete qHPV vaccine regimen (N=13) were enrolled to receive qHPV vaccine during the base study extension; participants designated as Not Completed are those who did not complete all three vaccinations and/or all required follow-up visits."
10824720|NCT00092534|EG003|Reported Event|LTFU: Cohort 1|Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.
11312507|NCT03186261|FG001|Participant Flow|Cavity Cleanser|"Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.~Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush."
11312508|NCT03186261|OG000|Outcome|Nano Silver Fluoride Solution|"Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.~Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties."
11312509|NCT03186261|OG001|Outcome|Cavity Cleanser|"Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.~Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush."
11312510|NCT03186261|EG000|Reported Event|Nano Silver Fluoride Solution|"Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.~Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties."
11312511|NCT03186261|EG001|Reported Event|Cavity Cleanser|"Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.~Cavity Cleanser: Moistens dentin surface after cavity preparation using a micro brush."
11312512|NCT03186378|BG000|Baseline|Exposure Group|"This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312513|NCT03186378|BG001|Baseline|Standard Group|"This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312514|NCT03186378|BG002|Baseline|Total|Total of all reporting groups
11312515|NCT03186378|FG000|Participant Flow|Exposure Group|"This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312516|NCT03186378|FG001|Participant Flow|Standard Group|"This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312517|NCT03186378|OG000|Outcome|Exposure Group|"This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312518|NCT03186378|OG001|Outcome|Standard Group|"This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312519|NCT03186378|EG000|Reported Event|Exposure Group|"This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312520|NCT03186378|EG001|Reported Event|Standard Group|"This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.~VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102."
11312521|NCT03186677|BG000|Baseline|Cohort 1|Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312522|NCT03186677|BG001|Baseline|Cohort 2|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312523|NCT03186677|BG002|Baseline|Cohort 3|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation
11312524|NCT03186677|BG003|Baseline|Cohort 4|One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation
11312525|NCT03186677|BG004|Baseline|Cohort 5|One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed by subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation
10824721|NCT00092534|EG004|Reported Event|LTFU: Cohort 2|Participants who received placebo in the Base Study and qHPV vaccine after completion of the Base Study and prior to entry into the LTFU. Cohort 2 provided a total of approximately 10 years of follow-up post-vaccination in the LTFU.
10824722|NCT00092547|BG000|Baseline|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
11312526|NCT03186677|BG005|Baseline|Total|Total of all reporting groups
11312527|NCT03186677|FG000|Participant Flow|Period 1, Cohort 1|Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312528|NCT03186677|FG001|Participant Flow|Period 1, Cohort 2|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312529|NCT03186677|FG002|Participant Flow|Period 1, Cohort 3|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation
11312530|NCT03186677|FG003|Participant Flow|Period 2, Cohort 4|One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation
11312531|NCT03186677|FG004|Participant Flow|Period 2, Cohort 5|One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed by subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation
11312532|NCT03186677|OG000|Outcome|Cohort 1|Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312533|NCT03186677|OG001|Outcome|Cohort 2|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312534|NCT03186677|OG002|Outcome|Cohort 3|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation
11312535|NCT03186677|OG003|Outcome|Cohort 4|One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation
11312536|NCT03186677|OG004|Outcome|Cohort 5|One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed by subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation
11312537|NCT03186677|EG000|Reported Event|Cohort 1|Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312538|NCT03186677|EG001|Reported Event|Cohort 2|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation
11312539|NCT03186677|EG002|Reported Event|Cohort 3|Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation
11312540|NCT03186677|EG003|Reported Event|Cohort 4|One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation
11312541|NCT03186677|EG004|Reported Event|Cohort 5|One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation
11312542|NCT03186781|BG000|Baseline|Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312543|NCT03186781|BG001|Baseline|Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312544|NCT03186781|BG002|Baseline|Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312545|NCT03186781|BG003|Baseline|Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312546|NCT03186781|BG004|Baseline|Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312547|NCT03186781|BG005|Baseline|Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312548|NCT03186781|BG006|Baseline|Total|Total of all reporting groups
11312549|NCT03186781|FG000|Participant Flow|Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312550|NCT03186781|FG001|Participant Flow|Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
10824723|NCT00092547|BG001|Baseline|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
10824724|NCT00092547|BG002|Baseline|Total|Total of all reporting groups
10824725|NCT00092547|FG000|Participant Flow|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
10824726|NCT00092547|FG001|Participant Flow|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
10824727|NCT00092547|FG002|Participant Flow|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
10824728|NCT00092547|OG000|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
10824729|NCT00092547|OG001|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
10824730|NCT00092547|OG001|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
10824731|NCT00092547|OG000|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
10824732|NCT00092547|OG000|Outcome|qHPV Vaccine in Base Study|Represent participants randomized to the qHPV vaccine group
10824733|NCT00092547|EG000|Reported Event|qHPV Vaccine in Base: Vaccine Phase and Follow-up|Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.
10824734|NCT00092547|EG001|Reported Event|Placebo in Base: Vaccine Phase and Follow-up|"Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.~Adverse events are reported for this group from Day 1 to Month 30."
10824735|NCT00092547|EG002|Reported Event|qHPV Vaccine in Base: Extension and Long-term Follow-up|Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
10824736|NCT00092547|EG003|Reported Event|qHPV Vaccine in Extension: Extension and Long-term Follow-up|Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
10824737|NCT00093015|BG000|Baseline|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
10824738|NCT00093015|BG001|Baseline|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
10824739|NCT00093015|BG002|Baseline|Total|Total of all reporting groups
10824740|NCT00093015|FG000|Participant Flow|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
10824741|NCT00093015|FG001|Participant Flow|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
10824742|NCT00093015|OG000|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
10824743|NCT00093015|OG001|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
10824744|NCT00093015|EG000|Reported Event|Placebo|
11312551|NCT03186781|FG002|Participant Flow|Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
10824745|NCT00093015|EG001|Reported Event|Darbepoetin Alfa|
10824746|NCT00093041|BG000|Baseline|Zalutumumab 0.15 mg/kg|
10824747|NCT00093041|BG001|Baseline|Zalutumumab 0.5 mg/kg|
10824748|NCT00093041|BG002|Baseline|Zalutumumab 1 mg/kg|
10824749|NCT00093041|BG003|Baseline|Zalutumumab 2 mg/kg|
10824750|NCT00093041|BG004|Baseline|Zalutumumab 4 mg/kg|
10824751|NCT00093041|BG005|Baseline|Zalutumumab 8 mg/kg|
10824752|NCT00093041|BG006|Baseline|Total|Total of all reporting groups
10824753|NCT00093041|FG000|Participant Flow|Zalutumumab 0.15 mg/kg|
10824754|NCT00093041|FG001|Participant Flow|Zalutumumab 0.5 mg/kg|
10824755|NCT00093041|FG002|Participant Flow|Zalutumumab 1 mg/kg|
10824756|NCT00093041|FG003|Participant Flow|Zalutumumab 2 mg/kg|
10824757|NCT00093041|FG004|Participant Flow|Zalutumumab 4 mg/kg|
10824758|NCT00093041|FG005|Participant Flow|Zalutumumab 8 mg/kg|
10824759|NCT00093041|OG000|Outcome|Zalatumumab 0.15 mg/kg|
10824760|NCT00093041|OG001|Outcome|Zalutumumab 0.5 mg/kg|
10824761|NCT00093041|OG002|Outcome|Zalutumumab 1 mg/kg|
10824762|NCT00093041|OG003|Outcome|Zalutumumab 2 mg/kg|
10824763|NCT00093041|OG004|Outcome|Zalutumumab 4 mg/kg|
10824764|NCT00093041|OG005|Outcome|Zalutumumab 8 mg/kg|
10824765|NCT00093041|EG000|Reported Event|Zalutumumab 0.15 mg/kg|
10824766|NCT00093041|EG001|Reported Event|Zalutumumab 0.5 mg/kg|
10824767|NCT00093041|EG002|Reported Event|Zalutumumab 1 mg/kg|
10824768|NCT00093041|EG003|Reported Event|Zalutumumab 2 mg/kg|
10824769|NCT00093041|EG004|Reported Event|Zalutumumab 4 mg/kg|
10824770|NCT00093041|EG005|Reported Event|Zalutumumab 8 mg/kg|
10824771|NCT00093145|BG000|Baseline|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
10824772|NCT00093145|FG000|Participant Flow|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
10824773|NCT00093145|OG000|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
10824774|NCT00093145|EG000|Reported Event|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
10842590|NCT00248534|OG000|Outcome|IV Rituximab|"IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.~Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression~rituximab: given IV days 1,8, 15 and 22~methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)~temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles"
10842591|NCT00248534|EG000|Reported Event|IV Rituximab|"IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.~Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression~rituximab: given IV days 1,8, 15 and 22~methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)~temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles"
10842592|NCT00248547|BG000|Baseline|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842593|NCT00248547|BG001|Baseline|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842594|NCT00248547|BG002|Baseline|Total|Total of all reporting groups
10842595|NCT00248547|FG000|Participant Flow|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842596|NCT00248547|FG001|Participant Flow|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842597|NCT00248547|OG000|Outcome|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842598|NCT00248547|OG001|Outcome|Placebo (Sugar Pill)|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842599|NCT00248547|EG000|Reported Event|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842600|NCT00248547|EG001|Reported Event|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
10842601|NCT00248560|BG000|Baseline|Gemcitabine, Docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
10842602|NCT00248560|FG000|Participant Flow|Gemcitabine, Docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
10842603|NCT00248560|OG000|Outcome|Gemcitabine, Docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
10824775|NCT00093379|BG000|Baseline|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
10824776|NCT00093379|FG000|Participant Flow|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
10824777|NCT00093379|OG000|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
10824778|NCT00093379|EG000|Reported Event|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
10824779|NCT00093470|BG000|Baseline|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
10824780|NCT00093470|BG001|Baseline|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
10824781|NCT00093470|BG002|Baseline|Total|Total of all reporting groups
10824782|NCT00093470|FG000|Participant Flow|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
10824783|NCT00093470|FG001|Participant Flow|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
10824784|NCT00093470|OG000|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10824785|NCT00093470|OG001|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
10824786|NCT00093470|EG000|Reported Event|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10824787|NCT00093470|EG001|Reported Event|Arm B (Clinical Observation)|Patients undergo observation only.
10824788|NCT00093496|BG000|Baseline|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
10824789|NCT00093496|BG001|Baseline|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
10824790|NCT00093496|BG002|Baseline|Total|Total of all reporting groups
10824791|NCT00093496|FG000|Participant Flow|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
11333309|NCT03511937|FG000|Participant Flow|Sugar-Sweetened Beverage (SSB) Health Warning Label|Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage (SSB) containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
10824792|NCT00093496|FG001|Participant Flow|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
10824793|NCT00093496|OG000|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
10824794|NCT00093496|OG001|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
10824795|NCT00093496|EG000|Reported Event|All Patients Receiving Gemcitabine|All patients receiving gemcitabine were combined to analyze toxicity.
10824796|NCT00093756|BG000|Baseline|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy> bortezomib: Given IV> paclitaxel: Given IV> carboplatin: Given IV
10824797|NCT00093756|BG001|Baseline|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy> bortezomib: Given IV> paclitaxel: Given IV> carboplatin: Given IV
10824798|NCT00093756|BG002|Baseline|Total|Total of all reporting groups
10824799|NCT00093756|FG000|Participant Flow|Phase I|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
10824800|NCT00093756|FG001|Participant Flow|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
10824801|NCT00093756|OG000|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
10824802|NCT00093756|OG000|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
11312552|NCT03186781|FG003|Participant Flow|Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
10824803|NCT00093756|OG000|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
10824804|NCT00093756|OG000|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
10824805|NCT00093756|EG000|Reported Event|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
10824806|NCT00093756|EG001|Reported Event|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
10824807|NCT00093782|BG000|Baseline|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10824808|NCT00093782|FG000|Participant Flow|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10824809|NCT00093782|OG000|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10824810|NCT00093782|EG000|Reported Event|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
10824811|NCT00093795|BG000|Baseline|TAC X 6|Doxorubicin, cyclophosphamide, and docetaxel. Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
10824812|NCT00093795|BG001|Baseline|AC X 4 Then P X 4|Doxorubicin, cyclophosphamide, and paclitaxel Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
10824813|NCT00093795|BG002|Baseline|AC X 4 Then PG X 4|Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
10824814|NCT00093795|BG003|Baseline|Total|Total of all reporting groups
10824815|NCT00093795|FG000|Participant Flow|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824816|NCT00093795|FG001|Participant Flow|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824817|NCT00093795|FG002|Participant Flow|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824818|NCT00093795|OG000|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824819|NCT00093795|OG001|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824820|NCT00093795|OG002|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
10824821|NCT00093795|EG000|Reported Event|TAC X 6|TAC X 6
10824822|NCT00093795|EG001|Reported Event|AC X 4 Then P X 4|AC X 4 then P X 4
10824823|NCT00093795|EG002|Reported Event|AC X 4 Then PG X 4|AC X 4 then PG X 4
10824824|NCT00093808|BG000|Baseline|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
10824825|NCT00093808|FG000|Participant Flow|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
10824826|NCT00093808|OG000|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
10824827|NCT00093808|EG000|Reported Event|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
10824828|NCT00093847|BG000|Baseline|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
10824829|NCT00093847|BG001|Baseline|Oral Adjunct Placebo|Participants receiving placebo
10824830|NCT00093847|BG002|Baseline|Total|Total of all reporting groups
10824831|NCT00093847|FG000|Participant Flow|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
10824832|NCT00093847|FG001|Participant Flow|Oral Adjunct Placebo|Participants receiving placebo
10824833|NCT00093847|OG000|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
10824834|NCT00093847|OG001|Outcome|Oral Adjunct Placebo|Participants receiving placebo
10824835|NCT00093847|EG000|Reported Event|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
10824836|NCT00093847|EG001|Reported Event|Oral Adjunct Placebo|Participants receiving placebo
10824837|NCT00093964|BG000|Baseline|Cilengitide 500 Milligrams (mg)|Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824838|NCT00093964|BG001|Baseline|Cilengitide 2000 mg|Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824839|NCT00093964|BG002|Baseline|Total|Total of all reporting groups
10824840|NCT00093964|FG000|Participant Flow|Cilengitide 500 Milligram (mg)|Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824841|NCT00093964|FG001|Participant Flow|Cilengitide 2000 mg|Subjects received 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824842|NCT00093964|OG000|Outcome|Cilengitide 500 Milligrams (mg)|Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824843|NCT00093964|OG001|Outcome|Cilengitide 2000 mg|Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824844|NCT00093964|OG000|Outcome|Cilengitide 500 Milligram (mg)|Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824845|NCT00093964|OG001|Outcome|Cilengitide 2000 mg|Subjects received 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824846|NCT00093964|EG000|Reported Event|Cilengitide 500 Milligram (mg)|Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824847|NCT00093964|EG001|Reported Event|Cilengitide 2000 mg|Subjects received 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
10824848|NCT00094055|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824849|NCT00094055|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824850|NCT00094055|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824851|NCT00094055|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824852|NCT00094094|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824853|NCT00094094|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824854|NCT00094094|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824855|NCT00094094|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
10824856|NCT00094107|BG000|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10824857|NCT00094107|FG000|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10824858|NCT00094107|OG000|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10824859|NCT00094107|EG000|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
10824860|NCT00094172|BG000|Baseline|Atorvastatin|Drug: Atorvastatin
10824861|NCT00094172|BG001|Baseline|Placebo|Non-Active Comparator
10824862|NCT00094172|BG002|Baseline|Total|Total of all reporting groups
10824863|NCT00094172|FG000|Participant Flow|Atorvastatin|Drug: Atorvastatin
10824864|NCT00094172|FG001|Participant Flow|Placebo|Non-Active Comparator
10824865|NCT00094172|OG000|Outcome|Atorvastatin|Drug: Atorvastatin
10824866|NCT00094172|OG001|Outcome|Placebo|Non-Active Comparator
10824867|NCT00094172|EG000|Reported Event|Atorvastatin|Drug: Atorvastatin
10824868|NCT00094172|EG001|Reported Event|Placebo|Non-Active Comparator
10824869|NCT00094211|BG000|Baseline|High Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824870|NCT00094211|BG001|Baseline|High Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824871|NCT00094211|BG002|Baseline|Low Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824872|NCT00094211|BG003|Baseline|Low Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824873|NCT00094211|BG004|Baseline|Total|Total of all reporting groups
10824874|NCT00094211|FG000|Participant Flow|High Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/High Income quadrant.
10824875|NCT00094211|FG001|Participant Flow|High Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/Low Income quadrant.
10824876|NCT00094211|FG002|Participant Flow|Low Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the Low Walkability/High Income quadrant.
10824877|NCT00094211|FG003|Participant Flow|Low Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/Low Income quadrant.
10824878|NCT00094211|OG000|Outcome|High Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824879|NCT00094211|OG001|Outcome|High Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824880|NCT00094211|OG002|Outcome|Low Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824881|NCT00094211|OG003|Outcome|Low Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.
10824882|NCT00094211|OG000|Outcome|High Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/High Income quadrant.
10824883|NCT00094211|OG001|Outcome|High Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/Low Income quadrant.
10824884|NCT00094211|OG002|Outcome|Low Walkability/High Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the Low Walkability/High Income quadrant.
10824885|NCT00094211|OG003|Outcome|Low Walkability/Low Income|Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods. This arm represents the High Walkability/Low Income quadrant.
10824886|NCT00094211|EG000|Reported Event|High Walkability/High Income|"Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.~There were no treatment conditions in this cross-sectional observational study. No adverse events were reported."
10824887|NCT00094211|EG001|Reported Event|High Walkability/Low Income|"Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.~There were no treatment conditions in this cross-sectional observational study. No adverse events were reported."
11333310|NCT03511937|FG001|Participant Flow|Neutral Label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
10824888|NCT00094211|EG002|Reported Event|Low Walkability/High Income|"Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.~There were no treatment conditions in this cross-sectional observational study. No adverse events were reported."
10824889|NCT00094211|EG003|Reported Event|Low Walkability/Low Income|"Households were enumerated in King County, WA and in the Baltimore, MD-Washington, DC area based on geographical information systems-derived walkability index and neighborhood-level income. Four quadrants were derived based on these two factors: higher walkability-higher income; higher walkability-lower income; lower walkability-higher income; and lower walkability-lower income neighborhoods.~There were no treatment conditions in this cross-sectional observational study. No adverse events were reported."
10824890|NCT00094302|BG000|Baseline|Placebo|Placebo of spironolactone
10824891|NCT00094302|BG001|Baseline|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
10824892|NCT00094302|BG002|Baseline|Total|Total of all reporting groups
10824893|NCT00094302|FG000|Participant Flow|Placebo|Placebo of spironolactone
10824894|NCT00094302|FG001|Participant Flow|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
10824895|NCT00094302|OG000|Outcome|Placebo|Placebo of spironolactone
10824896|NCT00094302|OG001|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
10824897|NCT00094302|EG000|Reported Event|Placebo|Placebo of spironolactone
10824898|NCT00094302|EG001|Reported Event|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
10824899|NCT00094328|BG000|Baseline|Open Label Bicalutamide With Anastrozole|Patients with testotoxicosis (familial male-limited precocious puberty) were given study drugs (bicalutamide in combination with anastrozole) orally once-daily for 12 months. The dosing of bicalutamide and anastrozole was independently tailored for each patient.
10824900|NCT00094328|FG000|Participant Flow|Open Label Bicalutamide With Anastrozole|Patients with testotoxicosis (familial male-limited precocious puberty) were given study drugs (bicalutamide in combination with anastrozole) orally once-daily for 12 months. The dosing of bicalutamide and anastrozole was independently tailored for each patient.
10824901|NCT00094328|OG000|Outcome|Open Label Bicalutamide With Anastrozole|Patients with testotoxicosis (familial male-limited precocious puberty) were given study drugs (bicalutamide in combination with anastrozole) orally once-daily for 12 months. The dosing of bicalutamide and anastrozole was independently tailored for each patient.
10824902|NCT00094328|EG000|Reported Event|Open Label Bicalutamide With Anastrozole|Patients with testotoxicosis (familial male-limited precocious puberty) were given study drugs (bicalutamide in combination with anastrozole) orally once-daily for 12 months. The dosing of bicalutamide and anastrozole was independently tailored for each patient.
10824903|NCT00094445|BG000|Baseline|Curcumin|Oral curcumin daily for eight weeks, starting dose 8 gm per day.
10824904|NCT00094445|FG000|Participant Flow|Curcumin|Oral curcumin daily for eight weeks, starting dose 8 gm per day.
10824905|NCT00094445|OG000|Outcome|Curcumin|Oral curcumin daily for eight weeks, starting dose 8 gm per day.
10824906|NCT00094445|EG000|Reported Event|Curcumin|Oral curcumin daily for eight weeks, starting dose 8 gm per day.
10824907|NCT00094458|BG000|Baseline|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824908|NCT00094458|BG001|Baseline|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824909|NCT00094458|BG002|Baseline|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824910|NCT00094458|BG003|Baseline|Total|Total of all reporting groups
10824911|NCT00094458|FG000|Participant Flow|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
11312553|NCT03186781|FG004|Participant Flow|Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312554|NCT03186781|FG005|Participant Flow|Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312555|NCT03186781|OG000|Outcome|Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312556|NCT03186781|OG001|Outcome|Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312557|NCT03186781|OG002|Outcome|Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312558|NCT03186781|OG003|Outcome|Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312559|NCT03186781|OG004|Outcome|Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312560|NCT03186781|OG005|Outcome|Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312561|NCT03186781|OG006|Outcome|Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)|HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
11312562|NCT03186781|OG000|Outcome|Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312563|NCT03186781|OG001|Outcome|Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs|"DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312564|NCT03186781|OG002|Outcome|Overall Incidence DNA A/Sing (4 mg)|DNA A/Sing prime dose groups included H2-naïve and H2-exposed adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
11312565|NCT03186781|OG000|Outcome|HA-F A/Sing (20 mcg), Ages 18-47 Yrs|"HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312566|NCT03186781|OG001|Outcome|HA-F A/Sing (60 mcg), Ages 18-47 and 52-70 Yrs|"HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity)~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312567|NCT03186781|OG002|Outcome|DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 and 52-70 Yrs|DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity)
11312568|NCT03186781|EG000|Reported Event|Overall Incidence HA-F A/Sing (20 mcg)|"HA-F A/Sing (20 mcg) dose group included H2-naïve (ages 18-47 years) adults who received a single 20 mcg dose of HA-F A/Sing.~Population included all enrolled subjects who received a HA-F A/Sing (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5).~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine."
11312569|NCT03186781|EG001|Reported Event|Overall Incidence HA-F A/Sing (60 mcg)|"HA-F A/Sing (60 mcg) dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received either two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.~Population included all enrolled subjects who received at least one HA-F A/Sing (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=42). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.~VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312570|NCT03186781|EG002|Reported Event|Overall Incidence DNA A/Sing (4 mg)|"DNA A/Sing prime dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.~Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).~VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine."
11312571|NCT03187002|BG000|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|"Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.~SHAM: Moderate IV Sedation: Sham IV to ensure blinding"
11312572|NCT03187002|BG001|Baseline|Moderate IV Sedation|"Fentanyl, versed~Moderate IV Sedation: IV sedation with fentanyl and versed~SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding"
11312573|NCT03187002|BG002|Baseline|Total|Total of all reporting groups
11312574|NCT03187002|FG000|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|"Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.~SHAM: Moderate IV Sedation: Sham IV to ensure blinding"
11312575|NCT03187002|FG001|Participant Flow|Moderate IV Sedation|"Fentanyl, versed~Moderate IV Sedation: IV sedation with fentanyl and versed~SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding"
11312576|NCT03187002|OG000|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|"Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.~SHAM: Moderate IV Sedation: Sham IV to ensure blinding"
11312577|NCT03187002|OG001|Outcome|Moderate IV Sedation|"Fentanyl, versed~Moderate IV Sedation: IV sedation with fentanyl and versed~SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding"
11312578|NCT03187002|EG000|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|"Transcutaneous electrical nerve stimulation (TENS)~Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.~SHAM: Moderate IV Sedation: Sham IV to ensure blinding"
11312579|NCT03187002|EG001|Reported Event|Moderate IV Sedation|"Fentanyl, versed~Moderate IV Sedation: IV sedation with fentanyl and versed~SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding"
11312580|NCT03187119|BG000|Baseline|Pictorial Asthma Action Plan|"Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP.~Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP."
11312581|NCT03187119|BG001|Baseline|Written Asthma Action Plan|"Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP.~Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP."
10824912|NCT00094458|FG001|Participant Flow|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824913|NCT00094458|FG002|Participant Flow|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824914|NCT00094458|FG003|Participant Flow|Azathioprine + Placebo/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
10824915|NCT00094458|FG004|Participant Flow|Infliximab + Placebo/Infliximab|Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
10824916|NCT00094458|FG005|Participant Flow|Infliximab + Azathioprine/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
10824917|NCT00094458|OG000|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824918|NCT00094458|OG001|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824919|NCT00094458|OG002|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
10824920|NCT00094458|EG000|Reported Event|W30-Azathioprine + Placebo|Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
10824921|NCT00094458|EG001|Reported Event|W30-Infliximab + Placebo|Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
10824922|NCT00094458|EG002|Reported Event|W30-Infliximab + Azathioprine|Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
10824923|NCT00094458|EG003|Reported Event|W50-Azathioprine + Placebo|(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
10824924|NCT00094458|EG004|Reported Event|W50-Infliximab + Placebo|Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
10824925|NCT00094458|EG005|Reported Event|W50-Infliximab + Azathioprine|Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
10824926|NCT00094458|EG006|Reported Event|OLE-Azathioprine + Placebo/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
10824927|NCT00094458|EG007|Reported Event|OLE-Infliximab + Placebo/Infliximab|Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
10824928|NCT00094458|EG008|Reported Event|OLE-Infliximab + Azathioprine/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
10824929|NCT00094497|BG000|Baseline|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
10824930|NCT00094497|BG001|Baseline|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
10824931|NCT00094497|BG002|Baseline|Total|Total of all reporting groups
11312582|NCT03187119|BG002|Baseline|Total|Total of all reporting groups
10824932|NCT00094497|FG000|Participant Flow|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
10824933|NCT00094497|FG001|Participant Flow|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
10824934|NCT00094497|OG000|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
10824935|NCT00094497|OG001|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
11312583|NCT03187119|FG000|Participant Flow|Pictorial Asthma Action Plan|"Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP.~Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP."
11312584|NCT03187119|FG001|Participant Flow|Written Asthma Action Plan|"Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP.~Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP."
11312585|NCT03187119|OG000|Outcome|Pictorial Asthma Action Plan|"Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP.~Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP."
11312586|NCT03187119|OG001|Outcome|Written Asthma Action Plan|"Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP.~Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP."
11312587|NCT03187119|EG000|Reported Event|Pictorial Asthma Action Plan|"Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP.~Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP."
11312588|NCT03187119|EG001|Reported Event|Written Asthma Action Plan|"Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP.~Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP."
11312589|NCT03187132|BG000|Baseline|Digital Pain Reduction Kit|"Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.~Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain."
11312590|NCT03187132|BG001|Baseline|Active Control|"Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.~Active Control: An active control TENS unit used to reduce acute localized pain."
11312591|NCT03187132|BG002|Baseline|Total|Total of all reporting groups
11312592|NCT03187132|FG000|Participant Flow|Digital Pain Reduction Kit|"Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.~Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain."
11312593|NCT03187132|FG001|Participant Flow|Active Control|"Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.~Active Control: An active control TENS unit used to reduce acute localized pain."
10824936|NCT00094497|EG000|Reported Event|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
10824937|NCT00094497|EG001|Reported Event|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
10824938|NCT00094536|BG000|Baseline|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
10824939|NCT00094536|FG000|Participant Flow|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
10824940|NCT00094536|OG000|Outcome|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
10824941|NCT00094536|EG000|Reported Event|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
10824942|NCT00094575|BG000|Baseline|Endovascular Repair|Endovascular Repair
10824943|NCT00094575|BG001|Baseline|Open Repair|Standard Open Repair
10824944|NCT00094575|BG002|Baseline|Total|Total of all reporting groups
10824945|NCT00094575|FG000|Participant Flow|Endovascular Repair|Endovascular Repair
10824946|NCT00094575|FG001|Participant Flow|Open Repair|Standard Open Repair
10824947|NCT00094575|OG000|Outcome|Endovascular Repair|Endovascular Repair
10824948|NCT00094575|OG001|Outcome|Open Repair|Standard Open Repair
10824949|NCT00094575|OG000|Outcome|Endovascular Repair|
10824950|NCT00094575|OG001|Outcome|Standard Open Repair|
11312594|NCT03187132|OG000|Outcome|Digital Pain Reduction Kit|"Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.~Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain."
10824951|NCT00094575|EG000|Reported Event|Endovascular Repair|Endovascular Repair
10824952|NCT00094575|EG001|Reported Event|Open Repair|Standard Open Repair
10824953|NCT00094653|BG000|Baseline|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824954|NCT00094653|BG001|Baseline|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824955|NCT00094653|BG002|Baseline|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824956|NCT00094653|BG003|Baseline|Total|Total of all reporting groups
10824957|NCT00094653|FG000|Participant Flow|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824958|NCT00094653|FG001|Participant Flow|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824959|NCT00094653|FG002|Participant Flow|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824960|NCT00094653|OG000|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824961|NCT00094653|OG001|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
11312595|NCT03187132|OG001|Outcome|Active Control|"Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.~Active Control: An active control TENS unit used to reduce acute localized pain."
11312596|NCT03187132|EG000|Reported Event|Digital Pain Reduction Kit|"Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.~Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain."
11312597|NCT03187132|EG001|Reported Event|Active Control|"Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.~Active Control: An active control TENS unit used to reduce acute localized pain."
11312598|NCT03187197|BG000|Baseline|Cohort A|Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
11312599|NCT03187197|BG001|Baseline|Cohort B - Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
11312600|NCT03187197|BG002|Baseline|Cohort B - VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
11312601|NCT03187197|BG003|Baseline|Total|Total of all reporting groups
11312602|NCT03187197|FG000|Participant Flow|Cohort A|Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
11312603|NCT03187197|FG001|Participant Flow|Cohort B - Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
11312604|NCT03187197|FG002|Participant Flow|Cohort B - VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
11312605|NCT03187197|OG000|Outcome|Cohort A|Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
11312606|NCT03187197|OG000|Outcome|Cohort B - Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
11312607|NCT03187197|OG001|Outcome|Cohort B - VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
11312608|NCT03187197|EG000|Reported Event|Cohort A|Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
11312609|NCT03187197|EG001|Reported Event|Cohort B - Pradaxa®|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
11312610|NCT03187197|EG002|Reported Event|Cohort B - VKA|Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
11312611|NCT03187301|BG000|Baseline|Overall (Cross-Over)|"Patients who successfully completed the Dose Titration Phase of the study were randomized to 1 of 6 treatment sequences in the single-dose Randomized Crossover Assessment Phase. Following confirmation by both the Investigator and the patient that the patient was in the 'OFF' state, the patient was dosed according to the patient's random treatment assignment with~APL-130277 at the dose determined in the Dose Titration Phase; OR~Matched placebo APL-130277; OR~A single 400 mg dose of moxifloxacin. Patients were randomized in equal numbers to 6 possible sequences of the above 3 study treatments determined by a 3-way balanced crossover design.~There was a 3-day washout period between treatment period dosing visits. Dosing of APL-130277 and placebo was double-blinded, and dosing of moxifloxacin was open-label."
11312612|NCT03187301|FG000|Participant Flow|APL-130277, Then Placebo, Then Moxifloxacin|Sequence 1: Participants first received APL-130277. After a 3-day washout period, they then received Placebo. After a 3-day washout period, they then received Moxifloxacin.
11312613|NCT03187301|FG001|Participant Flow|Placebo, Then Moxifloxacin, Then APL-130277|Sequence 2: Participants first received Placebo. After a 3-day washout period, they then received Moxifloxacin. After a 3-day washout period, they then received APL-130277.
11312614|NCT03187301|FG002|Participant Flow|Moxifloxacin, Then APL-130277, Then Placebo|Sequence 3: Participants first received Moxifloxacin. After a 3-day washout period, they then received APL-130277. After a 3-day washout period, they then received Placebo.
11312615|NCT03187301|FG003|Participant Flow|Moxifloxacin, Then Placebo, Then APL-130277|Sequence 4: Participants first received Moxifloxacin. After a 3-day washout period, they then received Placebo. After a 3-day washout period, they then received APL-130277.
11312616|NCT03187301|FG004|Participant Flow|APL-130277, Then Moxifloxacin, Then Placebo|Sequence 5: Participants first received APL-130277. After a 3-day washout period, they then received Moxifloxacin. After a 3-day washout period, they then received Placebo.
11312617|NCT03187301|FG005|Participant Flow|Placebo, Then APL-130277, Then Moxifloxacin|Sequence 6: Participants first received Placebo. After a 3-day washout period, they then received APL-130277. After a 3-day washout period, they then received Moxifloxacin.
11312618|NCT03187301|FG006|Participant Flow|Sequence Not Assigned|Sequence Not Assigned: Participants not randomized to a treatment sequence.
10824962|NCT00094653|OG001|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824963|NCT00094653|OG002|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824964|NCT00094653|EG000|Reported Event|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824965|NCT00094653|EG001|Reported Event|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824966|NCT00094653|EG002|Reported Event|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
10824967|NCT00094757|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824968|NCT00094757|BG001|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824969|NCT00094757|BG002|Baseline|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
10824970|NCT00094757|BG003|Baseline|Total|Total of all reporting groups
10824971|NCT00094757|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824972|NCT00094757|FG001|Participant Flow|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824973|NCT00094757|FG002|Participant Flow|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
10824974|NCT00094757|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824975|NCT00094757|OG001|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824976|NCT00094757|OG002|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
10824977|NCT00094757|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824978|NCT00094757|EG001|Reported Event|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
10824979|NCT00094757|EG002|Reported Event|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
10824980|NCT00094770|BG000|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
10824981|NCT00094770|BG001|Baseline|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
10824982|NCT00094770|BG002|Baseline|Total|Total of all reporting groups
10824983|NCT00094770|FG000|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
10824984|NCT00094770|FG001|Participant Flow|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
10824985|NCT00094770|OG000|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
10824986|NCT00094770|OG001|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
10824987|NCT00094770|EG000|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
11312619|NCT03187301|OG000|Outcome|APL-130277 (Cross-over)|Patients who received a single dose of APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Assessment Crossover Phase.
11312620|NCT03187301|OG001|Outcome|Placebo (Cross-over)|Patients who received a single dose of placebo in 1 of the 3 treatment period dosing visits during the Randomized Assessment Crossover Phase.
11312621|NCT03187301|OG000|Outcome|10 mg APL-130277 PK Subset|Patients who received a single dose of 10 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312622|NCT03187301|OG001|Outcome|15mg AP:-130277 PK Subset|Patients who received a single dose of 15 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312623|NCT03187301|OG002|Outcome|20 mg AP:-130277 PK Subset|Patients who received a single dose of 20 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312624|NCT03187301|OG003|Outcome|25 mg APL-130277 PK Subset|Patients who received a single dose of 25 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312625|NCT03187301|OG004|Outcome|35 mg APL-130277 PK Subset|Patients who received a single dose of 35 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312626|NCT03187301|OG005|Outcome|50 mg AP:-130277 PK Subset|Patients who received a single dose of 50 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312627|NCT03187301|OG001|Outcome|15 mg APL-130277 PK Subset|Patients who received a single dose of 15 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312628|NCT03187301|OG002|Outcome|20 mg APL-130277 PK Subset|Patients who received a single dose of 20 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312629|NCT03187301|OG005|Outcome|50 mg APL-130277 PK Subset|Patients who received a single dose of 50 mg APL-130277 (as determined in the Dose Titration Phase) in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312630|NCT03187301|OG001|Outcome|Placebo (Crossover)|Patients who received a single dose of placebo in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312631|NCT03187301|OG002|Outcome|Moxifloxacin (Crossover)|Patients who received a single dose of 400 mg moxifloxacin in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312632|NCT03187301|OG000|Outcome|APL-130277 (Titration)|"Patients were titrated to an effective and tolerable dose of APL-130277. Patients were dosed with increasing doses of APL 130277 starting with 10 mg at TV 1 up to a maximum of 60 mg. Patients who did not achieve a complete and full 'ON' response with the 10 mg APL 130277 dose at TV1 restarted their normal PD medications and were asked to return to the clinic the next business day for TV2, to assess the next highest dose. The evaluation continued sequentially with 15 mg (TV2), 20 mg (TV3), 25 mg (TV4), 30 mg (TV5), 35 mg (TV6), 40 mg (TV7), 50 mg (TV8), and 60 mg (TV9) doses of APL-130277 until a full 'ON' state was achieved. If tolerated, patients were titrated to a supratherapeutic dose (up to 60 mg) which was 1 or 2 levels above the initial dose producing an 'ON' response. If the patient was unable to tolerate 1 or either of the 2 additional dose levels after reaching a full ON state patients were randomized to the previous tolerable dose."
11312633|NCT03187301|OG000|Outcome|Moxifloxacin (Crossover)|Patients who received a single dose of 400 mg moxifloxacin in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11333311|NCT03511937|OG000|Outcome|Sugar-Sweetened Beverage Health Warning Label|Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
11333312|NCT03511937|OG001|Outcome|Neutral Label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11333313|NCT03511937|OG000|Outcome|Sugar-Sweetened Beverage Health Warning Label|Sugar-Sweetened Beverage Health Warning Label: Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
11333314|NCT03511937|OG001|Outcome|Neutral Label|Neutral Label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11333315|NCT03511937|EG000|Reported Event|Sugar-Sweetened Beverage Health Warning Label|Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
11333316|NCT03511937|EG001|Reported Event|Neutral Label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
11333317|NCT03512028|BG000|Baseline|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-8.~RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
10824988|NCT00094770|EG001|Reported Event|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
10824989|NCT00094809|BG000|Baseline|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824990|NCT00094809|BG001|Baseline|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824991|NCT00094809|BG002|Baseline|Total|Total of all reporting groups
10824992|NCT00094809|FG000|Participant Flow|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824993|NCT00094809|FG001|Participant Flow|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824994|NCT00094809|OG000|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824995|NCT00094809|OG001|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
10824996|NCT00094809|EG000|Reported Event|Placebo|
10824997|NCT00094809|EG001|Reported Event|Pegfilgrastim|
10824998|NCT00094835|BG000|Baseline|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10824999|NCT00094835|BG001|Baseline|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825000|NCT00094835|BG002|Baseline|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825001|NCT00094835|BG003|Baseline|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825002|NCT00094835|BG004|Baseline|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825003|NCT00094835|BG005|Baseline|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825004|NCT00094835|BG006|Baseline|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825005|NCT00094835|BG007|Baseline|Total|Total of all reporting groups
10825006|NCT00094835|FG000|Participant Flow|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825007|NCT00094835|FG001|Participant Flow|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825008|NCT00094835|FG002|Participant Flow|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825009|NCT00094835|FG003|Participant Flow|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825010|NCT00094835|FG004|Participant Flow|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825011|NCT00094835|FG005|Participant Flow|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825012|NCT00094835|FG006|Participant Flow|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825013|NCT00094835|OG000|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825014|NCT00094835|OG001|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825015|NCT00094835|OG002|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825016|NCT00094835|OG003|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825017|NCT00094835|OG004|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825018|NCT00094835|OG005|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825019|NCT00094835|OG006|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825020|NCT00094835|OG000|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825021|NCT00094835|OG001|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825022|NCT00094835|OG002|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825023|NCT00094835|OG003|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825024|NCT00094835|OG004|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825025|NCT00094835|EG000|Reported Event|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825026|NCT00094835|EG001|Reported Event|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825027|NCT00094835|EG002|Reported Event|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825028|NCT00094835|EG003|Reported Event|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825029|NCT00094835|EG004|Reported Event|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825030|NCT00094835|EG005|Reported Event|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
10825031|NCT00094835|EG006|Reported Event|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
11312634|NCT03187301|EG000|Reported Event|APL-130277 (Titration)|"Patients were titrated to an effective and tolerable dose of APL-130277. Patients were dosed with increasing doses of APL 130277 starting with 10 mg at TV 1 up to a maximum of 60 mg. Patients who did not achieve a complete and full 'ON' response with the 10 mg APL 130277 dose at TV1 restarted their normal PD medications and were asked to return to the clinic the next business day for TV2, to assess the next highest dose. The evaluation continued sequentially with 15 mg (TV2), 20 mg (TV3), 25 mg (TV4), 30 mg (TV5), 35 mg (TV6), 40 mg (TV7), 50 mg (TV8), and 60 mg (TV9) doses of APL-130277 until a full 'ON' state was achieved. If tolerated, patients were titrated to a supratherapeutic dose (up to 60 mg) which was 1 or 2 levels above the initial dose producing an 'ON' response. If the patient was unable to tolerate 1 or either of the 2 additional dose levels after reaching a full ON state patients were randomized to the previous tolerable dose."
11312635|NCT03187301|EG001|Reported Event|APL-130277 (Cross-over)|"Patients who successfully completed the Dose Titration Phase of the study were randomized to 1 of 6 treatment sequences in the single-dose Randomized Crossover Assessment Phase. Following confirmation by both the Investigator and the patient that the patient was in the 'OFF' state, the patient was dosed according to the patient's random treatment assignment with~APL-130277 at the dose determined in the Dose Titration Phase; OR~Matched placebo APL-130277; OR~A single 400 mg dose of moxifloxacin. Patients were randomized in equal numbers to 6 possible sequences of the above 3 study treatments determined by a 3-way balanced crossover design.~There was a 3-day washout period between treatment period dosing visits. Dosing of APL-130277 and placebo was double-blinded, and dosing of moxifloxacin was open-label."
11312636|NCT03187301|EG002|Reported Event|Placebo (Crossover)|Patients who received a single dose of placebo in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312637|NCT03187301|EG003|Reported Event|Moxifloxacin (Crossover)|Patients who received a single dose of 400 mg moxifloxacin in 1 of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase.
11312638|NCT03187418|BG000|Baseline|Micropulse Trans-scleral CPC|"A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).~MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse on time-0.5ms; micropulse off time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.~The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).~The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s)."
11312639|NCT03187418|FG000|Participant Flow|Micropulse Trans-scleral CPC|"A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).~MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse on time-0.5ms; micropulse off time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.~The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).~The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s)."
11312640|NCT03187418|OG000|Outcome|Micropulse Trans-scleral CPC|"A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).~MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse on time-0.5ms; micropulse off time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.~The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).~The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s)."
11312641|NCT03187418|EG000|Reported Event|Micropulse Trans-scleral CPC|"A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).~MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse on time-0.5ms; micropulse off time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.~The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).~The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s)."
11312642|NCT03187678|BG000|Baseline|Selexipag|Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 & Day 3) and back to Uptravi during Period 3
11312643|NCT03187678|FG000|Participant Flow|Selexipag|Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 & Day 3) and back to Uptravi during Period 3
10825032|NCT00094861|BG000|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825033|NCT00094861|BG001|Baseline|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825034|NCT00094861|BG002|Baseline|Total|Total of all reporting groups
10825035|NCT00094861|FG000|Participant Flow|Placebo|"Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
10825036|NCT00094861|FG001|Participant Flow|Palifermin|"Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
10825037|NCT00094861|OG000|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825038|NCT00094861|OG001|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825039|NCT00094861|EG000|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825040|NCT00094861|EG001|Reported Event|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
10825041|NCT00094887|BG000|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
10825042|NCT00094887|BG001|Baseline|Placebo|Nitrogen gas
10825043|NCT00094887|BG002|Baseline|Total|Total of all reporting groups
10825044|NCT00094887|FG000|Participant Flow|Inhaled Nitric Oxide|Participants receive Inhaled Nitric Oxide (INO)
10825045|NCT00094887|FG001|Participant Flow|Placebo|Participants receive Nitrogen gas
10825046|NCT00094887|OG000|Outcome|Inhaled Nitric Oxide|Participants receive Inhaled Nitric Oxide (INO)
10825047|NCT00094887|OG001|Outcome|Placebo|Participants receive Nitrogen gas
10825048|NCT00094887|EG000|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
10825049|NCT00094887|EG001|Reported Event|Placebo|Nitrogen gas
10825050|NCT00094900|BG000|Baseline|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
10825051|NCT00094900|FG000|Participant Flow|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
10825052|NCT00094900|OG000|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
10825053|NCT00094900|EG000|Reported Event|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
10825054|NCT00095056|BG000|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825055|NCT00095056|BG001|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825056|NCT00095056|BG002|Baseline|Total|Total of all reporting groups
10848547|NCT00290355|BG000|Baseline|GSK 249553 Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
11312644|NCT03187678|OG000|Outcome|Selexipag|Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 & Day 3) and back to Uptravi during Period 3
10825057|NCT00095056|FG000|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825058|NCT00095056|FG001|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825059|NCT00095056|OG000|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825060|NCT00095056|OG001|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825061|NCT00095056|EG000|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825062|NCT00095056|EG001|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
10825063|NCT00095121|BG000|Baseline|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
10825064|NCT00095121|BG001|Baseline|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
10825065|NCT00095121|BG002|Baseline|Total|Total of all reporting groups
10825066|NCT00095121|FG000|Participant Flow|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The adefovir dipivoxil (ADV) baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind [DB] ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
11312645|NCT03187678|EG000|Reported Event|Selexipag|Subjects treated with a stable dose of oral selexipag (Uptravi) between 200 and 1600 ug twice daily continued to take Uptravi at their prescribed dose during Period 1 (Day 1), then they were switched to intravenous (iv) selexipag during period 2 (3 doses, Day 2 & Day 3) and back to Uptravi during Period 3
10825067|NCT00095121|FG001|Participant Flow|PLB - ADV|Placebo (PLB) was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of open-label (OL) ADV treatment (ADV Week 192). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
10825068|NCT00095121|OG000|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet.
10825069|NCT00095121|OG001|Outcome|Placebo (PLB)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group.
10825070|NCT00095121|OG000|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
10825071|NCT00095121|OG001|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
10825072|NCT00095121|OG000|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
10825073|NCT00095121|OG000|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV-treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
10825074|NCT00095121|OG001|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
10825075|NCT00095121|OG000|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV-treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
10825076|NCT00095121|OG000|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment during the double-blind treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Randomized and Treated Analysis Set (RAT) included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
10825077|NCT00095121|OG001|Outcome|Placebo (PBL)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the double-blind treatment period. RAT included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
10825078|NCT00095121|EG000|Reported Event|ADV (Double-Blind)|Once daily treatment during the DB treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Treatment-emergent adverse events (AEs) for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
10825079|NCT00095121|EG001|Reported Event|PLB (Double-Blind)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the DB treatment period. Treatment-emergent AEs for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
10842604|NCT00248560|OG000|Outcome|Gemcitabine, Docetaxel|"Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.~docetaxel: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.~Gemcitabine: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine."
10825080|NCT00095121|EG002|Reported Event|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV-treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 - 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
10825081|NCT00095121|EG003|Reported Event|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 - 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
10825082|NCT00095147|BG000|Baseline|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825083|NCT00095147|BG001|Baseline|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825084|NCT00095147|BG002|Baseline|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825085|NCT00095147|BG003|Baseline|Total|Total of all reporting groups
10825086|NCT00095147|FG000|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825087|NCT00095147|FG001|Participant Flow|Infliximab (INF) + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825088|NCT00095147|FG002|Participant Flow|Placebo (PLA) + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825089|NCT00095147|FG003|Participant Flow|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825090|NCT00095147|FG004|Participant Flow|ABA + MTX [Open-label (OL)]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
10825091|NCT00095147|OG000|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825092|NCT00095147|OG001|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825093|NCT00095147|OG000|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825094|NCT00095147|OG000|Outcome|ABA + MTX [DB[|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825095|NCT00095147|OG001|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825096|NCT00095147|OG002|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
10825097|NCT00095147|OG002|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825098|NCT00095147|OG000|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825099|NCT00095147|OG000|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
10825100|NCT00095147|OG002|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825101|NCT00095147|OG001|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825102|NCT00095147|OG000|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825103|NCT00095147|EG000|Reported Event|ABA (DB)|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825104|NCT00095147|EG001|Reported Event|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
10825105|NCT00095147|EG002|Reported Event|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly).
10825106|NCT00095147|EG003|Reported Event|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, 104 participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
10825107|NCT00095173|BG000|Baseline|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
10825108|NCT00095173|FG000|Participant Flow|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
10825109|NCT00095173|FG001|Participant Flow|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
10825110|NCT00095173|FG002|Participant Flow|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
10825111|NCT00095173|FG003|Participant Flow|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
10825112|NCT00095173|FG004|Participant Flow|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
10825113|NCT00095173|FG005|Participant Flow|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
10825114|NCT00095173|OG000|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
10825115|NCT00095173|OG001|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
10825116|NCT00095173|OG000|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
10825117|NCT00095173|OG000|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
10825118|NCT00095173|OG001|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
10825119|NCT00095173|OG002|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
10825120|NCT00095173|OG000|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
10825121|NCT00095173|OG000|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
10825122|NCT00095173|EG000|Reported Event|Abatacept (Only Period A)|"Participants treated in Period A but did not in Periods B or C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses."
10825123|NCT00095173|EG001|Reported Event|Abatacept (Period A/Period C)|"Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C)."
10842605|NCT00248560|EG000|Reported Event|Gemcitabine, Docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
10825124|NCT00095173|EG002|Reported Event|Abatacept (Period A/Period B)|"All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years."
10825125|NCT00095173|EG003|Reported Event|Abatacept (Period A)/Placebo (Period B)|"All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.~Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years."
10825126|NCT00095199|BG000|Baseline|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825127|NCT00095199|BG001|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825128|NCT00095199|BG002|Baseline|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825129|NCT00095199|BG003|Baseline|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825130|NCT00095199|BG004|Baseline|Total|Total of all reporting groups
10825131|NCT00095199|FG000|Participant Flow|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825132|NCT00095199|FG001|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
10825133|NCT00095199|FG002|Participant Flow|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825134|NCT00095199|FG003|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825135|NCT00095199|OG000|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
10825136|NCT00095199|OG001|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825137|NCT00095199|OG002|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825138|NCT00095199|OG003|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825139|NCT00095199|OG000|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825140|NCT00095199|OG002|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week cycles), after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825141|NCT00095199|OG002|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week cycles).
10825142|NCT00095199|OG000|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week cycles) until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825143|NCT00095199|OG002|Outcome|Cetuximab + Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Day 1 of every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
10825144|NCT00095199|EG000|Reported Event|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825145|NCT00095199|EG001|Reported Event|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
10825146|NCT00095199|EG002|Reported Event|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
10825147|NCT00095199|EG003|Reported Event|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
10825148|NCT00095212|BG000|Baseline|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
10825149|NCT00095212|BG001|Baseline|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
10825150|NCT00095212|BG002|Baseline|Total|Total of all reporting groups
10825151|NCT00095212|FG000|Participant Flow|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
10825152|NCT00095212|FG001|Participant Flow|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
10825153|NCT00095212|OG000|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
10825154|NCT00095212|OG001|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
10825155|NCT00095212|EG000|Reported Event|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
10825156|NCT00095212|EG001|Reported Event|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
10825157|NCT00095238|BG000|Baseline|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825158|NCT00095238|BG001|Baseline|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825159|NCT00095238|BG002|Baseline|Total|Total of all reporting groups
10825160|NCT00095238|FG000|Participant Flow|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825161|NCT00095238|FG001|Participant Flow|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825162|NCT00095238|OG000|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825163|NCT00095238|OG001|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825164|NCT00095238|OG000|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 6
10825165|NCT00095238|OG001|Outcome|Irbesartan - Month 6|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 6
10825166|NCT00095238|OG002|Outcome|Placebo - Month 14|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 14
10825167|NCT00095238|OG003|Outcome|Irbesartan - Month 14|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 14
10825168|NCT00095238|OG000|Outcome|Placebo - Final Visit|Cohort of participants in Placebo group with MLwHF scores at Baseline and Final Visit
10825169|NCT00095238|OG001|Outcome|Irbesartan - Final Visit|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Final Visit
10825170|NCT00095238|OG000|Outcome|Placebo - Month 6|Placebo cohort with measurements at baseline and Month 6.
10825171|NCT00095238|OG001|Outcome|Irbesartan - Month 6|Irbesartan cohort with measurements at Baseline and Month 6.
10825172|NCT00095238|OG002|Outcome|Placebo - Month 14|Placebo cohort with measurements at Baseline and Month 14.
10825173|NCT00095238|OG003|Outcome|Irbesartan - Month 14|Irbesartan cohort with measurements at Baseline and Month 14.
10825174|NCT00095238|OG000|Outcome|Irbesartan Baseline Class I or II|Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
10825175|NCT00095238|OG001|Outcome|Irbesartan Class III or IV|Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
10825176|NCT00095238|OG002|Outcome|Irbesartan Baseline All Classes Combined|
10825177|NCT00095238|OG003|Outcome|Placebo Baseline Class I or II|
10825178|NCT00095238|OG004|Outcome|Placebo Class III or IV|
10825179|NCT00095238|OG005|Outcome|Placebo Baseline All Classes Combined|
10825180|NCT00095238|OG000|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 6
10825181|NCT00095238|OG001|Outcome|Irbesartan - Month 6|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 6
10825182|NCT00095238|OG002|Outcome|Placebo - Month 18|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 18
10825183|NCT00095238|OG003|Outcome|Irbesartan - Month 18|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 18
10825184|NCT00095238|OG004|Outcome|Placebo - Month 30|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 30
10825185|NCT00095238|OG005|Outcome|Irbesartan - Month 30|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 30
10825186|NCT00095238|OG000|Outcome|Placebo - Month 42|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 42
10825187|NCT00095238|OG001|Outcome|Irbesartan - Month 42|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 42
10825188|NCT00095238|OG002|Outcome|Placebo - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
10825189|NCT00095238|OG003|Outcome|Irbesartan - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
10825190|NCT00095238|OG004|Outcome|Placebo - Month 66|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 66
10825191|NCT00095238|OG005|Outcome|Irbesartan - Month 66|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 66
10825192|NCT00095238|OG000|Outcome|Irbesartan + ACE-I Use|
10825193|NCT00095238|OG001|Outcome|Placebo + ACE-I Use|
10825194|NCT00095238|OG002|Outcome|Irbesartan no ACE-I Use|
10825195|NCT00095238|OG003|Outcome|Placebo no ACE-I Use|
10825196|NCT00095238|EG000|Reported Event|IRBESARTAN|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825197|NCT00095238|EG001|Reported Event|PLACEBO|titration from 75 to 300 mg, once daily (QD), up to 6 years
10825198|NCT00095303|BG000|Baseline|BSFT|BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members
10825199|NCT00095303|BG001|Baseline|TAU- Treatment as Usual|TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
10825200|NCT00095303|BG002|Baseline|Total|Total of all reporting groups
10825201|NCT00095303|FG000|Participant Flow|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
10825202|NCT00095303|FG001|Participant Flow|Treatment as Usual|Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
10825203|NCT00095303|OG000|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
10825204|NCT00095303|OG001|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
10825205|NCT00095303|EG000|Reported Event|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
10825206|NCT00095303|EG001|Reported Event|Treatment as Usual|Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
10825207|NCT00095498|BG000|Baseline|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825208|NCT00095498|BG001|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825209|NCT00095498|BG002|Baseline|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
10825210|NCT00095498|BG003|Baseline|Total|Total of all reporting groups
10825211|NCT00095498|FG000|Participant Flow|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825212|NCT00095498|FG001|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825213|NCT00095498|FG002|Participant Flow|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
10825214|NCT00095498|OG000|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825215|NCT00095498|OG001|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825216|NCT00095498|OG002|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
10825217|NCT00095498|EG000|Reported Event|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
10825218|NCT00095498|EG001|Reported Event|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825219|NCT00095498|EG002|Reported Event|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
10825220|NCT00095563|BG000|Baseline|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10825221|NCT00095563|FG000|Participant Flow|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10825222|NCT00095563|OG000|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10825223|NCT00095563|EG000|Reported Event|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10825224|NCT00095576|BG000|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
10825225|NCT00095576|BG001|Baseline|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
10825226|NCT00095576|BG002|Baseline|Total|Total of all reporting groups
10825227|NCT00095576|FG000|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
10825228|NCT00095576|FG001|Participant Flow|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
10825229|NCT00095576|OG000|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
10825230|NCT00095576|OG001|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
10825231|NCT00095576|EG000|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
10825232|NCT00095576|EG001|Reported Event|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
10825233|NCT00095628|BG000|Baseline|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10825234|NCT00095628|FG000|Participant Flow|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10825235|NCT00095628|OG000|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10825236|NCT00095628|EG000|Reported Event|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
10825237|NCT00095836|BG000|Baseline|Gefitinib 250mg|Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
10825238|NCT00095836|FG000|Participant Flow|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
10825239|NCT00095836|OG000|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
10825240|NCT00095836|EG000|Reported Event|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
10825241|NCT00095875|BG000|Baseline|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
10825242|NCT00095875|BG001|Baseline|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
10825243|NCT00095875|BG002|Baseline|Total|Total of all reporting groups
10825244|NCT00095875|FG000|Participant Flow|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
10825245|NCT00095875|FG001|Participant Flow|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
11312646|NCT03187730|BG000|Baseline|Intervention Arm|"Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
10842606|NCT00248612|BG000|Baseline|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
11312647|NCT03187730|BG001|Baseline|Waitlist Control|"Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312648|NCT03187730|BG002|Baseline|Total|Total of all reporting groups
11312649|NCT03187730|FG000|Participant Flow|Intervention Arm|"Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312650|NCT03187730|FG001|Participant Flow|Waitlist Control|"Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312651|NCT03187730|OG000|Outcome|Intervention Arm|"Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312652|NCT03187730|OG001|Outcome|Waitlist Control|"Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312653|NCT03187730|EG000|Reported Event|Intervention Arm|"Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
10825246|NCT00095875|OG000|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
10825247|NCT00095875|OG001|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
10825248|NCT00095875|EG000|Reported Event|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
10825249|NCT00095875|EG001|Reported Event|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
10825250|NCT00095940|BG000|Baseline|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
10825251|NCT00095940|BG001|Baseline|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
11312654|NCT03187730|EG001|Reported Event|Waitlist Control|"Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.~Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT."
11312655|NCT03187756|BG000|Baseline|Cyclophosphamide|Cy 50 mg/kg IV, over approximately 1-2 hours (depending on volume), is given on Day 3 posttransplantation (ideally between 60 and 72 hours after marrow infusion) and on Day 4 (approximately 24 hours after Day 3 Cy).
11312656|NCT03187756|FG000|Participant Flow|Cyclophosphamide|Cy 50 mg/kg IV, over approximately 1-2 hours (depending on volume), is given on Day 3 posttransplantation (ideally between 60 and 72 hours after marrow infusion) and on Day 4 (approximately 24 hours after Day 3 Cy).
11312657|NCT03187756|OG000|Outcome|Cyclophosphamide|Cy 50 mg/kg IV, over approximately 1-2 hours (depending on volume), is given on Day 3 posttransplantation (ideally between 60 and 72 hours after marrow infusion) and on Day 4 (approximately 24 hours after Day 3 Cy).
11312658|NCT03187756|EG000|Reported Event|Cyclophosphamide|Cy 50 mg/kg IV, over approximately 1-2 hours (depending on volume), is given on Day 3 posttransplantation (ideally between 60 and 72 hours after marrow infusion) and on Day 4 (approximately 24 hours after Day 3 Cy).
11312659|NCT03188055|BG000|Baseline|Best Case/Worst Case Communication Tool|"The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient.~Best Case/Worst Case communication tool: The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes.~The surgeon verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
11312660|NCT03188055|BG001|Baseline|Usual Care|Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention.
11312661|NCT03188055|BG002|Baseline|Total|Total of all reporting groups
11312662|NCT03188055|FG000|Participant Flow|Trauma Care Provider Focus Group|Trauma Care Providers were enrolled in a focus group to assist in developing the intervention, prior to main study and randomization activities.
11312663|NCT03188055|FG001|Participant Flow|Usual Care - Control Group|Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention. Usual care consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.
11312664|NCT03188055|FG002|Participant Flow|Trauma Team Training|Using the best case/worst case training program, a trainer at the UT-S/PMH and OHSU sites trained consenting attending trauma surgeons and trauma team members. As part of the training, participants took part in an assessment session, demonstrating their use of the tool with a standardized patient and scripted clinical scenario.
11312665|NCT03188055|FG003|Participant Flow|Best Case/Worst Case Communication Tool|"The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient.~Best Case/Worst Case communication tool: The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes.~The surgeon verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
10825252|NCT00095940|BG002|Baseline|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
10825253|NCT00095940|BG003|Baseline|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
11312666|NCT03188055|FG004|Participant Flow|Participant Nurses|For the nurse-reported Quality of Communication (QoC) surveys, the primary nurse caring for an enrolled study patient was approached by a UT-S/PMH or OHSU research team member during their work shift and asked to participate by filling out a survey that assessed the QoC the patient and family have received over the prior 72 hours. Baseline characteristics were not collected for these participants and they were not randomized.
11312667|NCT03188055|FG005|Participant Flow|Moral Distress Survey (MDS) Responses|All nurses and physicians of the trauma units at UT-S/PMH and OHSU were invited to participate in this brief anonymous survey given at two time points: at the start of the study before the first patient is enrolled and at the end of the study, after the last patient is enrolled. These activities occurred prior to and after the main study and randomization activities.
10825254|NCT00095940|BG004|Baseline|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
10825255|NCT00095940|BG005|Baseline|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
10825256|NCT00095940|BG006|Baseline|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
10825257|NCT00095940|BG007|Baseline|Total|Total of all reporting groups
10825258|NCT00095940|FG000|Participant Flow|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
10825259|NCT00095940|FG001|Participant Flow|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
10825260|NCT00095940|FG002|Participant Flow|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
10825261|NCT00095940|FG003|Participant Flow|High Grade Glioma: Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
10825262|NCT00095940|FG004|Participant Flow|High Grade Glioma: No Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
10825263|NCT00095940|FG005|Participant Flow|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
10825264|NCT00095940|FG006|Participant Flow|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
10825265|NCT00095940|FG007|Participant Flow|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
10825266|NCT00095940|FG008|Participant Flow|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
10825267|NCT00095940|OG000|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
10825268|NCT00095940|OG001|Outcome|No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
10825269|NCT00095940|OG000|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
10825270|NCT00095940|OG001|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
10825271|NCT00095940|OG002|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
10825272|NCT00095940|OG000|Outcome|Lapatinib: No Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
10825273|NCT00095940|OG000|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
10825274|NCT00095940|OG001|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
10825275|NCT00095940|OG002|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
10825276|NCT00095940|EG000|Reported Event|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
10825277|NCT00095940|EG001|Reported Event|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.
10825278|NCT00095940|EG002|Reported Event|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.
10825279|NCT00095940|EG003|Reported Event|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.
10825280|NCT00095940|EG004|Reported Event|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
10825281|NCT00095940|EG005|Reported Event|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
10825282|NCT00095940|EG006|Reported Event|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
10825283|NCT00095979|BG000|Baseline|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
10825284|NCT00095979|FG000|Participant Flow|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
10825285|NCT00095979|OG000|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
10825286|NCT00095979|OG000|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
10825287|NCT00095979|OG001|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
10825288|NCT00095979|OG002|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
10825289|NCT00095979|OG003|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
10825290|NCT00095979|OG004|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
10825291|NCT00095979|EG000|Reported Event|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
10825292|NCT00096018|BG000|Baseline|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825293|NCT00096018|BG001|Baseline|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825294|NCT00096018|BG002|Baseline|Total|Total of all reporting groups
10825295|NCT00096018|FG000|Participant Flow|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825296|NCT00096018|FG001|Participant Flow|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825297|NCT00096018|OG000|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825298|NCT00096018|OG001|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825299|NCT00096018|EG000|Reported Event|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825300|NCT00096018|EG001|Reported Event|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
10825301|NCT00096031|BG000|Baseline|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
10825302|NCT00096031|FG000|Participant Flow|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
10825303|NCT00096031|OG000|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
10825304|NCT00096031|EG000|Reported Event|Cetuximab|
10825305|NCT00096044|BG000|Baseline|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
10825306|NCT00096044|FG000|Participant Flow|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
10825307|NCT00096044|OG000|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
10825308|NCT00096044|EG000|Reported Event|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
10825309|NCT00096109|BG000|Baseline|Treatment (Tanespimycin)|Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10825310|NCT00096109|FG000|Participant Flow|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
10825311|NCT00096109|OG000|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
10825312|NCT00096109|EG000|Reported Event|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~tanespimycin: Given IV~laboratory biomarker analysis: Correlative studies"
10825313|NCT00096122|BG000|Baseline|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
10825314|NCT00096122|FG000|Participant Flow|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
10825315|NCT00096122|OG000|Outcome|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
10825316|NCT00096122|EG000|Reported Event|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
10825317|NCT00096135|BG000|Baseline|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825318|NCT00096135|BG001|Baseline|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825319|NCT00096135|BG002|Baseline|Total|Total of all reporting groups
10825320|NCT00096135|FG000|Participant Flow|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825321|NCT00096135|FG001|Participant Flow|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825322|NCT00096135|OG000|Outcome|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825323|NCT00096135|OG001|Outcome|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825324|NCT00096135|EG000|Reported Event|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825325|NCT00096135|EG001|Reported Event|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
10825326|NCT00096161|BG000|Baseline|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825327|NCT00096161|BG001|Baseline|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825328|NCT00096161|BG002|Baseline|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825329|NCT00096161|BG003|Baseline|Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825330|NCT00096161|BG004|Baseline|Total|Total of all reporting groups
10825331|NCT00096161|FG000|Participant Flow|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
11312668|NCT03188055|OG000|Outcome|Best Case/Worst Case Communication Tool|"The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient.~Best Case/Worst Case communication tool: The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes.~The surgeon verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
11312669|NCT03188055|OG001|Outcome|Usual Care|Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention. Usual care consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.
11312670|NCT03188055|OG001|Outcome|Usual Care|Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention. Usual care also consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.
11312671|NCT03188055|OG000|Outcome|Pre-intervention Survey|Trauma unit nurses present in the ICU will be surveyed before clinicians learn to use the best case/worst case tool (at the start of the study, before the first patient is enrolled), to assess whether the communication intervention improves feelings of moral distress.
11312672|NCT03188055|OG001|Outcome|Post-intervention Survey|Trauma unit nurses present in the ICU will be surveyed after clinicians learn to use the best case/worst case tool (at the end of the study, after the last patient is enrolled), to assess whether the communication intervention improves feelings of moral distress.
11312673|NCT03188055|OG000|Outcome|Pre-intervention Survey|Trauma physicians present in the ICU will be surveyed before clinicians learn to use the best case/worst case tool (at the start of the study, before the first patient is enrolled), to assess whether the communication intervention improves feelings of moral distress.
11312674|NCT03188055|OG001|Outcome|Post-intervention Survey|Trauma unit physicians present in the ICU will be surveyed after clinicians learn to use the best case/worst case tool (at the end of the study, after the last patient is enrolled), to assess whether the communication intervention improves feelings of moral distress.
11312675|NCT03188055|EG000|Reported Event|Best Case/Worst Case Communication Tool|"The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient.~Best Case/Worst Case communication tool: The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes.~The surgeon verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
11312676|NCT03188055|EG001|Reported Event|Usual Care|Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention. Usual care also consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.
11312677|NCT03188120|BG000|Baseline|Spiriva Respimat Group|Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
11312678|NCT03188120|FG000|Participant Flow|Spiriva Respimat Group|Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
11312679|NCT03188120|OG000|Outcome|Spiriva Respimat Group|Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
11312680|NCT03188120|EG000|Reported Event|Spiriva Respimat Group|Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this noninterventional, observational study to collect new real world data (i.e., data under routine medical practice)
11312681|NCT03188185|BG000|Baseline|S1: Placebo|Randomized to placebo in Stage 1.
11312682|NCT03188185|BG001|Baseline|S1: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 1.
11312683|NCT03188185|BG002|Baseline|Total|Total of all reporting groups
11312684|NCT03188185|FG000|Participant Flow|S1: Placebo|Randomized to placebo in Stage 1
11312685|NCT03188185|FG001|Participant Flow|S1: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 1
11312686|NCT03188185|FG002|Participant Flow|S2: Placebo|Randomized to placebo in Stage 2
11312687|NCT03188185|FG003|Participant Flow|S2: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 2
11312688|NCT03188185|OG000|Outcome|S1: Placebo|Randomized to placebo in Stage 1
11312689|NCT03188185|OG001|Outcome|S1: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 1
11312690|NCT03188185|OG002|Outcome|S2: Placebo|Randomized to placebo in Stage 2
11312691|NCT03188185|OG003|Outcome|S2: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 2
11312692|NCT03188185|EG000|Reported Event|S1: Placebo|Randomized to placebo in Stage 1
11312693|NCT03188185|EG001|Reported Event|S1: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 1
11312694|NCT03188185|EG002|Reported Event|S2: Placebo|Randomized to placebo in Stage 2
11312695|NCT03188185|EG003|Reported Event|S2: ALKS 5461 2mg/2mg|Randomized to ALKS 5461 2mg/2mg in Stage 2
11312696|NCT03188263|BG000|Baseline|Bright Light|"Irradiance is 230 μW/m2 and lux is 500 lux.~Bright Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux."
11312697|NCT03188263|BG001|Baseline|Dim Light|"irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux~Dim Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux"
11312698|NCT03188263|BG002|Baseline|Total|Total of all reporting groups
11312699|NCT03188263|FG000|Participant Flow|Bright Light|"Irradiance is 230 μW/m2 and lux is 500 lux.~Bright Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux."
11312700|NCT03188263|FG001|Participant Flow|Dim Light|"irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux~Dim Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux"
11312701|NCT03188263|OG000|Outcome|Bright Light|"Irradiance is 230 μW/m2 and lux is 500 lux.~Bright Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux."
11312702|NCT03188263|OG001|Outcome|Dim Light|"irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux~Dim Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux"
11312703|NCT03188263|EG000|Reported Event|Bright Light|"Irradiance is 230 μW/m2 and lux is 500 lux.~Bright Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux."
11312704|NCT03188263|EG001|Reported Event|Dim Light|"irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux~Dim Light: 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux"
11312705|NCT03188523|BG000|Baseline|MK-8504 100 mg (Panel A)|Participants receive a single oral dose of MK-8504 100 mg.
11312706|NCT03188523|BG001|Baseline|MK-8504 240 mg (Panel B)|Participants receive a single oral dose of MK-8504 240 mg.
11312707|NCT03188523|BG002|Baseline|Total|Total of all reporting groups
11312708|NCT03188523|FG000|Participant Flow|MK-8504 100 mg (Panel A)|Participants receive a single oral dose of MK-8504 100 mg.
11312709|NCT03188523|FG001|Participant Flow|MK-8504 240 mg (Panel B)|Participants receive a single oral dose of MK-8504 240 mg.
11312710|NCT03188523|FG002|Participant Flow|MK-8504 ≤240 mg (Panel C)|Participants were to receive a single oral dose of MK-8504 ≤240 mg. This panel did not enroll any participants.
11312711|NCT03188523|FG003|Participant Flow|MK-8504 ≤240 mg (Panel D)|Participants were to receive a single oral dose of MK-8504 ≤240 mg. This panel did not enroll any participants.
11312712|NCT03188523|OG000|Outcome|MK-8504 100 mg (Panel A)|Participants receive a single oral dose of MK-8504 100 mg.
11312713|NCT03188523|OG001|Outcome|MK-8504 240 mg (Panel B)|Participants receive a single oral dose of MK-8504 240 mg.
11312714|NCT03188523|EG000|Reported Event|MK-8504 100 mg (Panel A)|Participants receive a single oral dose of MK-8504 100 mg.
11312715|NCT03188523|EG001|Reported Event|MK-8504 240 mg (Panel B)|Participants receive a single oral dose of MK-8504 240 mg.
11312716|NCT03188536|BG000|Baseline|Multiple Myeloma (MM) Participants|Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
11312717|NCT03188536|FG000|Participant Flow|Multiple Myeloma (MM) Participants|Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
11312718|NCT03188536|OG000|Outcome|Multiple Myeloma (MM) Participants|Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
11312719|NCT03188536|EG000|Reported Event|Multiple Myeloma (MM) Participants|Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
11312720|NCT03188718|BG000|Baseline|WatchPAT Intervention|"Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).~WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram."
11312721|NCT03188718|FG000|Participant Flow|WatchPAT Intervention|"Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).~WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram."
11312722|NCT03188718|OG000|Outcome|WatchPAT Intervention|"Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).~WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram."
11312723|NCT03188718|EG000|Reported Event|WatchPAT Intervention|"Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).~WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram."
11312724|NCT03188991|BG000|Baseline|Dose Escalation: NanoPac® 6 mg/mL|"Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312725|NCT03188991|BG001|Baseline|Dose Escalation: NanoPac® 10 mg/mL|"Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312726|NCT03188991|BG002|Baseline|Dose Escalation: NanoPac® 15 mg/mL|"Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312727|NCT03188991|BG003|Baseline|Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)|"Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312728|NCT03188991|BG004|Baseline|Total|Total of all reporting groups
11312729|NCT03188991|FG000|Participant Flow|Dose Escalation: NanoPac® 6 mg/mL|"Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312730|NCT03188991|FG001|Participant Flow|Dose Escalation: NanoPac® 10 mg/mL|"Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312731|NCT03188991|FG002|Participant Flow|Dose Escalation: NanoPac® 15 mg/mL|"Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312732|NCT03188991|FG003|Participant Flow|Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)|"Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312733|NCT03188991|OG000|Outcome|Dose Escalation: NanoPac® 6 mg/mL|"Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312734|NCT03188991|OG001|Outcome|Dose Escalation: NanoPac® 10 mg/mL|"Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312735|NCT03188991|OG002|Outcome|Dose Escalation: NanoPac® 15 mg/mL|"Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312736|NCT03188991|OG003|Outcome|Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)|"Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312737|NCT03188991|EG000|Reported Event|Dose Escalation: NanoPac® 6 mg/mL|"Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312738|NCT03188991|EG001|Reported Event|Dose Escalation: NanoPac® 10 mg/mL|"Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312739|NCT03188991|EG002|Reported Event|Dose Escalation: NanoPac® 15 mg/mL|"Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312740|NCT03188991|EG003|Reported Event|Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)|"Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.~NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)"
11312741|NCT03189134|BG000|Baseline|Imaging Arm|"Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes~Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging~Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue."
11312742|NCT03189134|FG000|Participant Flow|Imaging Arm|"Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes~Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging~Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue."
11312743|NCT03189134|OG000|Outcome|Imaging Arm|"Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes~Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging~Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue."
11312744|NCT03189134|EG000|Reported Event|Imaging Arm|"Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes~Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging~Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue."
11312745|NCT03189446|BG000|Baseline|Vaginal Cuff Brachytherapy + Chemotherapy|"Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles~Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted~Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles~Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles"
11312746|NCT03189446|FG000|Participant Flow|Vaginal Cuff Brachytherapy + Chemotherapy|"Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles~Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted~Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles~Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles"
11312747|NCT03189446|OG000|Outcome|Vaginal Cuff Brachytherapy + Chemotherapy|"Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles~Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted~Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles~Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles"
11312748|NCT03189446|EG000|Reported Event|Vaginal Cuff Brachytherapy + Chemotherapy|"Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles~Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted~Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles~Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles"
11312749|NCT03189524|BG000|Baseline|Part I: 160 mg BID|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D."
10825332|NCT00096161|FG001|Participant Flow|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825333|NCT00096161|FG002|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825334|NCT00096161|FG003|Participant Flow|Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825335|NCT00096161|OG000|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825336|NCT00096161|OG001|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825337|NCT00096161|OG002|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825338|NCT00096161|OG003|Outcome|Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825339|NCT00096161|EG000|Reported Event|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825340|NCT00096161|EG001|Reported Event|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825341|NCT00096161|EG002|Reported Event|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825342|NCT00096161|EG003|Reported Event|Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
10825343|NCT00096174|BG000|Baseline|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
10825344|NCT00096174|FG000|Participant Flow|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
10825345|NCT00096174|OG000|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
10825346|NCT00096174|EG000|Reported Event|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
11312750|NCT03189524|BG001|Baseline|Part I: 320 mg QD|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (320 mg QD) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312751|NCT03189524|BG002|Baseline|Part II: 160 mg BID|Dose Expansion: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL.
11312752|NCT03189524|BG003|Baseline|Total|Total of all reporting groups
11312753|NCT03189524|FG000|Participant Flow|Part I: 160 mg BID|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 milligrams (mg) (160 mg twice daily [BID], administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312754|NCT03189524|FG001|Participant Flow|Part I: 320 mg QD|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (320 mg once daily [QD]) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312755|NCT03189524|FG002|Participant Flow|Part II: 160 mg BID|Dose Expansion: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with follicular lymphoma (FL) or marginal zone lymphoma (MZL).
11312756|NCT03189524|OG000|Outcome|Part I: 160 mg BID|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312757|NCT03189524|OG001|Outcome|Part I: 320 mg QD|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (320 mg QD) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312758|NCT03189524|OG000|Outcome|Part II: 160 mg BID|Dose Expansion: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL.
11312759|NCT03189524|OG000|Outcome|160 mg BID|"Part I: Zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D.~Part II: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL."
11312760|NCT03189524|OG001|Outcome|320 mg QD|"Part I: Zanubrutinib 320 mg daily (QD) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312761|NCT03189524|OG000|Outcome|160 mg|"Part I: Zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D.~Part II: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL."
11312762|NCT03189524|OG000|Outcome|Part I: 160 mg BID or 320 mg QD|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) or 320 mg QD and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312763|NCT03189524|EG000|Reported Event|Part I: 160 mg BID|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312764|NCT03189524|EG001|Reported Event|Part I: 320 mg QD|"Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (320 mg QD) and a 3+3 design was adopted for Part I of the study to determine RP2D."
11312765|NCT03189524|EG002|Reported Event|Part II: 160 mg BID|Dose Expansion: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL.
11312766|NCT03189589|BG000|Baseline|GSK2269557 500 mcg|Eligible participants received a single dose of GSK2269557 500 mcg via the ELLIPTA DPI on Day 1.
11312767|NCT03189589|BG001|Baseline|GSK2269557 750 mcg|Eligible participants received a single dose of GSK2269557 750 mcg via the ELLIPTA DPI on Day 1.
11312768|NCT03189589|BG002|Baseline|Total|Total of all reporting groups
11312769|NCT03189589|FG000|Participant Flow|GSK2269557 500 mcg|Eligible participants received a single dose of GSK2269557 500 micrograms (mcg) via the ELLIPTA dry powder inhaler (DPI) on Day 1.
11312770|NCT03189589|FG001|Participant Flow|GSK2269557 750 mcg|Eligible participants received a single dose of GSK2269557 750 mcg via the ELLIPTA DPI on Day 1.
11312771|NCT03189589|OG000|Outcome|GSK2269557 500 mcg|Eligible participants received a single dose of GSK2269557 500 mcg via the ELLIPTA DPI on Day 1.
11312772|NCT03189589|OG001|Outcome|GSK2269557 750 mcg|Eligible participants received a single dose of GSK2269557 750 mcg via the ELLIPTA DPI on Day 1.
11312773|NCT03189589|EG000|Reported Event|GSK2269557 500 mcg|Eligible participants received a single dose of GSK2269557 500 mcg via the ELLIPTA DPI on Day 1.
11312774|NCT03189589|EG001|Reported Event|GSK2269557 750 mcg|Eligible participants received a single dose of GSK2269557 750 mcg via the ELLIPTA DPI on Day 1.
11312775|NCT03189745|BG000|Baseline|ACWY-TT Group|Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312776|NCT03189745|BG001|Baseline|MenPS Group|Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312777|NCT03189745|BG002|Baseline|Total|Total of all reporting groups
11312778|NCT03189745|FG000|Participant Flow|ACWY-TT Group|Participants received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312779|NCT03189745|FG001|Participant Flow|MenPS Group|Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312780|NCT03189745|OG000|Outcome|ACWY-TT Group|Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312781|NCT03189745|OG001|Outcome|MenPS Group|Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312782|NCT03189745|EG000|Reported Event|ACWY-TT Group|Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312783|NCT03189745|EG001|Reported Event|MenPS Group|Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination.
11312784|NCT03190005|BG000|Baseline|Group 1|"placebo control without medication.~Placebos: no medication, healthy subjects."
11312785|NCT03190005|BG001|Baseline|Group 2|"hyper-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312786|NCT03190005|BG002|Baseline|Group 3|"hypo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312787|NCT03190005|BG003|Baseline|Group 4|"normo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312788|NCT03190005|BG004|Baseline|Group 5|reaction after OPC-13013
11312789|NCT03190005|BG005|Baseline|Group 6|reaction after AR-C
11312790|NCT03190005|BG006|Baseline|Group 7|reaction after simastatin
11312791|NCT03190005|BG007|Baseline|Total|Total of all reporting groups
11312792|NCT03190005|FG000|Participant Flow|Group 1|"placebo control without medication.~Placebos: no medication, healthy subjects."
11312793|NCT03190005|FG001|Participant Flow|Group 2|"hyper-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312794|NCT03190005|FG002|Participant Flow|Group 3|"hypo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312795|NCT03190005|FG003|Participant Flow|Group 4|"normo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312796|NCT03190005|FG004|Participant Flow|Group 5|reaction after OPC-13013
11312797|NCT03190005|FG005|Participant Flow|Group 6|reaction after AR-C
11312798|NCT03190005|FG006|Participant Flow|Group 7|reaction after simastatin
11312799|NCT03190005|OG000|Outcome|Group 1|"placebo control without medication.~Placebos: no medication, healthy subjects."
11312800|NCT03190005|OG001|Outcome|Group 2|"hyper-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312801|NCT03190005|OG002|Outcome|Group 3|"hypo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312802|NCT03190005|OG003|Outcome|Group 4|"normo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312803|NCT03190005|OG004|Outcome|Group 5|"reaction after OPC-13013~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312804|NCT03190005|OG005|Outcome|Group 6|"reaction after AR-C~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312805|NCT03190005|OG006|Outcome|Group 7|"reaction after simastatin~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312806|NCT03190005|EG000|Reported Event|Group 1|"placebo control without medication.~Placebos: no medication, healthy subjects."
11312807|NCT03190005|EG001|Reported Event|Group 2|"hyper-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312808|NCT03190005|EG002|Reported Event|Group 3|"hypo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312809|NCT03190005|EG003|Reported Event|Group 4|"normo-reactive responser after clopidogrel.~clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)"
11312810|NCT03190005|EG004|Reported Event|Group 5|reaction after OPC-13013
11312811|NCT03190005|EG005|Reported Event|Group 6|reaction after AR-C
11312812|NCT03190005|EG006|Reported Event|Group 7|reaction after simastatin
10825347|NCT00096226|BG000|Baseline|Chemoradiation, Surgery, Chemotherapy|"Chemoradiation, surgery, chemotherapy~carboplatin~paclitaxel~adjuvant therapy~conventional surgery~neoadjuvant therapy~radiation therapy"
10825348|NCT00096226|FG000|Participant Flow|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
10825349|NCT00096226|OG000|Outcome|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
10825350|NCT00096226|EG000|Reported Event|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
10825351|NCT00096265|BG000|Baseline|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
10825352|NCT00096265|BG001|Baseline|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10825353|NCT00096265|BG002|Baseline|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
10825354|NCT00096265|BG003|Baseline|Total|Total of all reporting groups
10825355|NCT00096265|FG000|Participant Flow|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
10825356|NCT00096265|FG001|Participant Flow|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10825357|NCT00096265|FG002|Participant Flow|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
10825358|NCT00096265|OG000|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
10825359|NCT00096265|OG001|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
10825360|NCT00096265|OG002|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
10825361|NCT00096265|OG001|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10825362|NCT00096265|EG000|Reported Event|WBRT+SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.]
10825363|NCT00096265|EG001|Reported Event|Temozolomide+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.]
10825364|NCT00096265|EG002|Reported Event|Erlotinib+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
10825365|NCT00096278|BG000|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
10825366|NCT00096278|BG001|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10825367|NCT00096278|BG002|Baseline|Total|Total of all reporting groups
10825368|NCT00096278|FG000|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
10825369|NCT00096278|FG001|Participant Flow|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
11312813|NCT03190083|BG000|Baseline|3-dimensional Tomosynthesis Mammogram|"The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram~2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.~digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram."
10972092|NCT00919503|OG000|Outcome|Regimen A (PBSCT and BMT)|"CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1.~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~Allogeneic Bone Marrow Transplantation: Infused IV~Anti-Thymocyte Globulin: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Peripheral Blood Stem Cell Transplantation: Infused IV~Tacrolimus: Given IV or PO~Treosulfan: Given IV"
10972093|NCT00919503|OG001|Outcome|Regimen B (UBCT)|"CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 .~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD.~Anti-Thymocyte Globulin: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo total body irradiation~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV"
10972094|NCT00919503|EG000|Reported Event|Regimen A (PBSCT and BMT)|"CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1.~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.~Allogeneic Bone Marrow Transplantation: Infused IV~Anti-Thymocyte Globulin: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Methotrexate: Given IV~Peripheral Blood Stem Cell Transplantation: Infused IV~Tacrolimus: Given IV or PO~Treosulfan: Given IV"
11092654|NCT01541215|BG000|Baseline|Liraglutide 1.8 mg|After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
10825370|NCT00096278|OG000|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
10825371|NCT00096278|OG001|Outcome|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10825372|NCT00096278|OG000|Outcome|Arm I (mFOLFOX6)|"Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10825373|NCT00096278|OG001|Outcome|Arm II (Bevacizumab, mFOLFOX6)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~bevacizumab: Given IV"
10825374|NCT00096278|EG000|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
10972095|NCT00919503|EG001|Reported Event|Regimen B (UBCT)|"CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 .~TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status.~Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD.~Anti-Thymocyte Globulin: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV or PO~Total-Body Irradiation: Undergo total body irradiation~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV"
10972096|NCT00919633|BG000|Baseline|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972097|NCT00919633|BG001|Baseline|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972098|NCT00919633|BG002|Baseline|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10825375|NCT00096278|EG001|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
10825376|NCT00096356|BG000|Baseline|Arm 1 - CoQ10 & Vitamin E|CoQ10 plus Vitamin E 100mg/day in 3 doses
10825377|NCT00096356|BG001|Baseline|Arm 2 - Placebo & Vitamin E|Placebo plus Vitamin E 100mg/day in 3 doses
10825378|NCT00096356|BG002|Baseline|Total|Total of all reporting groups
10825379|NCT00096356|FG000|Participant Flow|Arm 1 - CoQ10 + Vitamin E|CoQ10 + Vitamin E 100mg/day in 3 doses
10825380|NCT00096356|FG001|Participant Flow|Arm 2 - Placebo + Vitamin E|Placebo + Vitamin E 100mg/day in 3 doses
10825381|NCT00096356|OG000|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
10825382|NCT00096356|OG001|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
10825383|NCT00096356|OG000|Outcome|Arm 1- CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
10825384|NCT00096356|EG000|Reported Event|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
10825385|NCT00096356|EG001|Reported Event|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
10825386|NCT00096382|BG000|Baseline|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825387|NCT00096382|BG001|Baseline|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825388|NCT00096382|BG002|Baseline|Total|Total of all reporting groups
10825389|NCT00096382|FG000|Participant Flow|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825390|NCT00096382|FG001|Participant Flow|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825391|NCT00096382|OG000|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825392|NCT00096382|OG001|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825393|NCT00096382|EG000|Reported Event|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825394|NCT00096382|EG001|Reported Event|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
10825395|NCT00096447|BG000|Baseline|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10825396|NCT00096447|FG000|Participant Flow|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10825397|NCT00096447|OG000|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10825398|NCT00096447|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10825399|NCT00096447|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10825400|NCT00096447|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10825401|NCT00096447|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10825402|NCT00096447|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10825403|NCT00096447|EG000|Reported Event|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10825404|NCT00096460|BG000|Baseline|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
10825405|NCT00096460|BG001|Baseline|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
10825406|NCT00096460|BG002|Baseline|Total|Total of all reporting groups
10825407|NCT00096460|FG000|Participant Flow|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
10825408|NCT00096460|FG001|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
10825409|NCT00096460|OG000|Outcome|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
10825410|NCT00096460|OG001|Outcome|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
11312814|NCT03190083|FG000|Participant Flow|3-dimensional Tomosynthesis Mammogram|"The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram~2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.~digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram."
11312815|NCT03190083|OG000|Outcome|3-dimensional Tomosynthesis Mammogram|"The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram~2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.~digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram."
11312816|NCT03190083|EG000|Reported Event|3-dimensional Tomosynthesis Mammogram|"The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram~2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.~digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram."
11312817|NCT03190213|BG000|Baseline|Pembrolizumab: All Patients|Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
11312818|NCT03190213|FG000|Participant Flow|Pembrolizumab: All Patients|Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
11312819|NCT03190213|OG000|Outcome|Pembrolizumab: All Patients|Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
11312820|NCT03190213|EG000|Reported Event|Pembrolizumab: All Patients|Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
11312821|NCT03190993|BG000|Baseline|Sugar Sweetened Solid Treatment|"A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.~Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily."
11312822|NCT03190993|BG001|Baseline|Sugar Sweetened Beverage Treatment|"20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.~Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily."
11312823|NCT03190993|BG002|Baseline|Total|Total of all reporting groups
11312824|NCT03190993|FG000|Participant Flow|Sugar Sweetened Solid Treatment|"A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.~Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily."
11312825|NCT03190993|FG001|Participant Flow|Sugar Sweetened Beverage Treatment|"20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.~Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily."
11312826|NCT03190993|OG000|Outcome|Sugar Sweetened Solid Treatment|"A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.~Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily."
11312827|NCT03190993|OG001|Outcome|Sugar Sweetened Beverage Treatment|"20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.~Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily."
11312828|NCT03190993|EG000|Reported Event|Sugar Sweetened Solid Treatment|"A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.~Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily."
11312829|NCT03190993|EG001|Reported Event|Sugar Sweetened Beverage Treatment|"20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.~Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily."
11312830|NCT03191396|BG000|Baseline|Semaglutide 1.0 mg|Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
10972099|NCT00919633|BG003|Baseline|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972100|NCT00919633|BG004|Baseline|Total|Total of all reporting groups
10972101|NCT00919633|FG000|Participant Flow|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972102|NCT00919633|FG001|Participant Flow|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972103|NCT00919633|FG002|Participant Flow|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972104|NCT00919633|FG003|Participant Flow|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972105|NCT00919633|OG000|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972106|NCT00919633|OG001|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972107|NCT00919633|OG002|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972108|NCT00919633|OG003|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
11312831|NCT03191396|BG001|Baseline|Liraglutide 1.2 mg|Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
10972109|NCT00919633|EG000|Reported Event|PEGINTRON 1.5|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972110|NCT00919633|EG001|Reported Event|INTRON A 80,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972111|NCT00919633|EG002|Reported Event|INTRON A 120,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972112|NCT00919633|EG003|Reported Event|INTRON A 160,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
10972113|NCT00919711|BG000|Baseline|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
10972114|NCT00919711|BG001|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
10972115|NCT00919711|BG002|Baseline|Total|Total of all reporting groups
10972116|NCT00919711|FG000|Participant Flow|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
10972117|NCT00919711|FG001|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
10972118|NCT00919711|OG000|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
10972119|NCT00919711|OG001|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
10972120|NCT00919711|EG000|Reported Event|Risedronate 150 mg QM|
10972121|NCT00919711|EG001|Reported Event|Denosumab 60 mg Q6M|
10972122|NCT00919724|BG000|Baseline|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
10972123|NCT00919724|BG001|Baseline|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
10972124|NCT00919724|BG002|Baseline|Total|Total of all reporting groups
10972125|NCT00919724|FG000|Participant Flow|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
10972126|NCT00919724|FG001|Participant Flow|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
11312832|NCT03191396|BG002|Baseline|Total|Total of all reporting groups
10972127|NCT00919724|OG000|Outcome|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
10972128|NCT00919724|OG001|Outcome|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
10972129|NCT00919724|EG000|Reported Event|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
10972130|NCT00919724|EG001|Reported Event|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
10972131|NCT00919763|BG000|Baseline|CD2027 Ointment 3 mcg/g, Twice Daily|Topical Ointment
10972132|NCT00919763|BG001|Baseline|CD 2027 Vehicle, Twice Daily|Topical Ointment
10972133|NCT00919763|BG002|Baseline|Total|Total of all reporting groups
10972134|NCT00919763|FG000|Participant Flow|CD2027 Ointment 3 mcg/g, Twice Daily|Topical Ointment
10972135|NCT00919763|FG001|Participant Flow|CD 2027 Vehicle, Twice Daily|Topical Ointment
10972136|NCT00919763|OG000|Outcome|CD2027 Ointment 3 mcg/g, Twice Daily|Topical Ointment
10972137|NCT00919763|OG001|Outcome|CD 2027 Vehicle, Twice Daily|Topical Ointment
10972138|NCT00919763|EG000|Reported Event|CD2027 Ointment 3 mcg/g, Twice Daily|Topical Ointment
10972139|NCT00919763|EG001|Reported Event|CD 2027 Vehicle, Twice Daily|Topical Ointment
10972140|NCT00919802|BG000|Baseline|All Study Participants|Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.
10972141|NCT00919802|FG000|Participant Flow|Intranasal Oxytocin, Followed by Intranasal Saline|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
10972142|NCT00919802|FG001|Participant Flow|Intranasal Saline Followed With Intranasal Oxytocin|"Saline, 4ml intranasally, once~Patients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.~Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time they will receive the alternative intranasal agent, Oxytocin a single dose of oxytocin 40 IU (20 IU to each nostril). Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
10972143|NCT00919802|OG000|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
10972144|NCT00919802|OG001|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
10972145|NCT00919802|EG000|Reported Event|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
10972146|NCT00919802|EG001|Reported Event|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
11092655|NCT01541215|BG001|Baseline|Placebo|After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
11092656|NCT01541215|BG002|Baseline|Total|Total of all reporting groups
11092657|NCT01541215|FG000|Participant Flow|Liraglutide 1.8 mg|After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
11092658|NCT01541215|FG001|Participant Flow|Placebo|After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
10972147|NCT00919854|BG000|Baseline|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
10972148|NCT00919854|FG000|Participant Flow|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
10972149|NCT00919854|OG000|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
10972150|NCT00919854|EG000|Reported Event|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
10972151|NCT00919867|BG000|Baseline|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
10972152|NCT00919867|BG001|Baseline|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
10972153|NCT00919867|BG002|Baseline|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
10972154|NCT00919867|BG003|Baseline|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
10972155|NCT00919867|BG004|Baseline|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
10972156|NCT00919867|BG005|Baseline|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
10972157|NCT00919867|BG006|Baseline|Total|Total of all reporting groups
10972158|NCT00919867|FG000|Participant Flow|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
10972159|NCT00919867|FG001|Participant Flow|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
10972160|NCT00919867|FG002|Participant Flow|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
10972161|NCT00919867|FG003|Participant Flow|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
10972162|NCT00919867|FG004|Participant Flow|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
10972163|NCT00919867|FG005|Participant Flow|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
10972164|NCT00919867|OG000|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
10972165|NCT00919867|OG001|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
10972166|NCT00919867|OG000|Outcome|Vyvanse Alone|Single 50 mg dose
10972167|NCT00919867|EG000|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
10972168|NCT00919867|EG001|Reported Event|Vyvanse Alone|Single 50 mg dose
10972169|NCT00919867|EG002|Reported Event|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
10972170|NCT00919932|BG000|Baseline|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
11312833|NCT03191396|FG000|Participant Flow|Semaglutide 1.0 mg|Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312834|NCT03191396|FG001|Participant Flow|Liraglutide 1.2 mg|Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312835|NCT03191396|OG000|Outcome|Semaglutide 1.0 mg|Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312836|NCT03191396|OG001|Outcome|Liraglutide 1.2 mg|Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312837|NCT03191396|EG000|Reported Event|Semaglutide 1.0 mg|Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312838|NCT03191396|EG001|Reported Event|Liraglutide 1.2 mg|Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
11312839|NCT03191552|BG000|Baseline|SPIO 2 Hours|"SPIO 2 hours (worn SPIO 2 hours during therapy)~9 were allocated, one of them lost follow up before the assessment at 1 month and 8 completed"
11312840|NCT03191552|BG001|Baseline|SPIO 6 Hours|"SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy).~9 were allocated, one of them withdrew due to surgery for progressive hip dysplasia between the assessments at 1 month and 3 months and 8 completed."
11312841|NCT03191552|BG002|Baseline|Control (Conventional Exercises)|Control group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study
11312842|NCT03191552|BG003|Baseline|Total|Total of all reporting groups
11312843|NCT03191552|FG000|Participant Flow|SPIO(Stabilizing Pressure Input Orthosis) 2 Hours|"All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.~SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.~SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.~SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.~(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross"
11312844|NCT03191552|FG001|Participant Flow|SPIO (Stabilizing Pressure Input Orthosis) 6 Hours|"SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.~SPIO (stabilizing input pressure orthosis): SPIO 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.~SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.~(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills"
10972171|NCT00919932|BG001|Baseline|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
10972172|NCT00919932|BG002|Baseline|Total|Total of all reporting groups
10972173|NCT00919932|FG000|Participant Flow|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
10972174|NCT00919932|FG001|Participant Flow|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
10972175|NCT00919932|OG000|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
10972176|NCT00919932|OG001|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
10972177|NCT00919932|EG000|Reported Event|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
10972178|NCT00919932|EG001|Reported Event|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
10972179|NCT00920023|BG000|Baseline|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
11312845|NCT03191552|FG002|Participant Flow|Control (Conventional Exercises)|"Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks~conventional exercises: range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills"
10972180|NCT00920023|FG000|Participant Flow|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
10972181|NCT00920023|OG000|Outcome|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
10972182|NCT00920023|EG000|Reported Event|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
10972183|NCT00920075|BG000|Baseline|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
10972184|NCT00920075|FG000|Participant Flow|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
10972185|NCT00920075|OG000|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
11312846|NCT03191552|OG000|Outcome|Before Treatment|SPIO groups before treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
11312847|NCT03191552|OG001|Outcome|Immediately After Orthosis Worn|Immediate evaluation after orthosis worn
11312848|NCT03191552|OG000|Outcome|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
11312849|NCT03191552|OG001|Outcome|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
11312850|NCT03191552|OG002|Outcome|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
11312851|NCT03191552|OG000|Outcome|Before Treatment|Box and Block Test Score of SPIO groups before Treatment (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
11312852|NCT03191552|OG001|Outcome|İmmediate After Orthosis Wear|Box and Block Test Score of SPIO groups immediate after the orthosis wear (orthosis is tailor made and only children in SPIO groups had the orthosis so the arm control (conventinal exercises) group is not included)
11312853|NCT03191552|EG000|Reported Event|SPIO 2 Hours|SPIO 2 hours (worn SPIO 2 hours during therapy)
11312854|NCT03191552|EG001|Reported Event|SPIO 6 Hours|SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy)
11312855|NCT03191552|EG002|Reported Event|Control (Conventional Exercises)|Control group (received only conventional exercise therapy),
11312856|NCT03191630|BG000|Baseline|Control|"This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.~Fitbit (Control): Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session."
11312857|NCT03191630|BG001|Baseline|Intervention|"This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention~SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes.."
11312858|NCT03191630|BG002|Baseline|Total|Total of all reporting groups
11312859|NCT03191630|FG000|Participant Flow|Control|"This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.~Fitbit (Control): Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session."
11312860|NCT03191630|FG001|Participant Flow|Intervention|"This arm includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE & activity tracker intervention~SystemCHANGE & Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to be encouraged to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session."
11312861|NCT03191630|OG000|Outcome|Control|"This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.~Fitbit (Control): Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session."
11312862|NCT03191630|OG001|Outcome|Intervention|"This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention~SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. ."
11335883|NCT03558230|BG000|Baseline|Vibration|"The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Vibration: Vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
10972186|NCT00920075|EG000|Reported Event|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
10972187|NCT00920140|BG000|Baseline|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
10972188|NCT00920140|BG001|Baseline|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972189|NCT00920140|BG002|Baseline|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
10972190|NCT00920140|BG003|Baseline|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
10972191|NCT00920140|BG004|Baseline|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
10972192|NCT00920140|BG005|Baseline|Total|Total of all reporting groups
10972193|NCT00920140|FG000|Participant Flow|GSK1120212 < 2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
10972194|NCT00920140|FG001|Participant Flow|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972195|NCT00920140|FG002|Participant Flow|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.
10972196|NCT00920140|FG003|Participant Flow|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
10972197|NCT00920140|FG004|Participant Flow|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
10972198|NCT00920140|OG000|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
10972199|NCT00920140|OG001|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972200|NCT00920140|OG000|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
10972201|NCT00920140|OG001|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
10972202|NCT00920140|OG002|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
10972203|NCT00920140|OG000|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
10972204|NCT00920140|OG001|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
10972205|NCT00920140|OG002|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972206|NCT00920140|OG000|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972207|NCT00920140|EG000|Reported Event|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
10972208|NCT00920140|EG001|Reported Event|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
10972209|NCT00920218|BG000|Baseline|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972210|NCT00920218|BG001|Baseline|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972211|NCT00920218|BG002|Baseline|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972212|NCT00920218|BG003|Baseline|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972213|NCT00920218|BG004|Baseline|Total|Total of all reporting groups
10972214|NCT00920218|FG000|Participant Flow|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
11312863|NCT03191630|OG001|Outcome|Intervention|"This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention.~SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes."
11312864|NCT03191630|OG001|Outcome|Intervention|"This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention~SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes."
11312865|NCT03191630|EG000|Reported Event|Control|"This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.~Fitbit (Control): Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session."
11312866|NCT03191630|EG001|Reported Event|Intervention|"This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention~SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes."
11312867|NCT03191799|BG000|Baseline|1.5 mg/kg Emicizumab QW|Participants were enrolled to receive initial weekly doses of prophylactic 3.0 mg/kg emicizumab subcutaneously (SC) for 4 weeks, followed by prophylactic maintenance doses consisting of 1.5 mg/kg emicizumab once a week (QW), administered SC for the remainder of the 2-year treatment period.
11312868|NCT03191799|FG000|Participant Flow|1.5 mg/kg Emicizumab QW|Participants were enrolled to receive initial weekly doses of prophylactic 3.0 mg/kg emicizumab subcutaneously (SC) for 4 weeks, followed by prophylactic maintenance doses consisting of 1.5 mg/kg emicizumab once a week (QW), administered SC for the remainder of the 2-year treatment period.
11312869|NCT03191799|OG000|Outcome|1.5 mg/kg Emicizumab QW|Participants were enrolled to receive initial weekly doses of prophylactic 3.0 mg/kg emicizumab subcutaneously (SC) for 4 weeks, followed by prophylactic maintenance doses consisting of 1.5 mg/kg emicizumab once a week (QW), administered SC for the remainder of the 2-year treatment period.
11312870|NCT03191799|EG000|Reported Event|1.5 mg/kg Emicizumab QW|Participants were enrolled to receive initial weekly doses of prophylactic 3.0 mg/kg emicizumab subcutaneously (SC) for 4 weeks, followed by prophylactic maintenance doses consisting of 1.5 mg/kg emicizumab once a week (QW), administered SC for the remainder of the 2-year treatment period.
11312871|NCT03192137|BG000|Baseline|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312872|NCT03192137|BG001|Baseline|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312873|NCT03192137|BG002|Baseline|Total|Total of all reporting groups
11312874|NCT03192137|FG000|Participant Flow|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312875|NCT03192137|FG001|Participant Flow|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312876|NCT03192137|OG000|Outcome|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312877|NCT03192137|OG001|Outcome|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312878|NCT03192137|EG000|Reported Event|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312879|NCT03192137|EG001|Reported Event|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
10972215|NCT00920218|FG001|Participant Flow|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972216|NCT00920218|FG002|Participant Flow|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972217|NCT00920218|FG003|Participant Flow|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972218|NCT00920218|OG000|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972219|NCT00920218|OG001|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972220|NCT00920218|OG002|Outcome|GSK 1437173A 2D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
10972221|NCT00920218|OG003|Outcome|Placebo 1D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
10972222|NCT00920218|OG004|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972223|NCT00920218|OG002|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972224|NCT00920218|OG003|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972225|NCT00920218|OG002|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule
10972226|NCT00920218|EG000|Reported Event|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972227|NCT00920218|EG001|Reported Event|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972228|NCT00920218|EG002|Reported Event|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972229|NCT00920218|EG003|Reported Event|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
10972230|NCT00920231|BG000|Baseline|Initial System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
10972231|NCT00920231|BG001|Baseline|Modified System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
10972232|NCT00920231|BG002|Baseline|Total|Total of all reporting groups
10972233|NCT00920231|FG000|Participant Flow|Initial Computer Vision System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
10972234|NCT00920231|FG001|Participant Flow|Modified Computer Vision System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
10972235|NCT00920231|OG000|Outcome|Initial System|The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
10972236|NCT00920231|OG001|Outcome|Modified System|a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
10825411|NCT00096460|EG000|Reported Event|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
10825412|NCT00096460|EG001|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
10842607|NCT00248612|BG001|Baseline|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
10842608|NCT00248612|BG002|Baseline|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
10842609|NCT00248612|BG003|Baseline|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
10842610|NCT00248612|BG004|Baseline|Total|Total of all reporting groups
10842611|NCT00248612|FG000|Participant Flow|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. They will also receive tailored cognitive behavioral training (CBT)
10842612|NCT00248612|FG001|Participant Flow|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
10842613|NCT00248612|FG002|Participant Flow|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
10842614|NCT00248612|FG003|Participant Flow|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
10842615|NCT00248612|OG000|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
10842616|NCT00248612|OG001|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
10842617|NCT00248612|OG002|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
10842618|NCT00248612|OG003|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
10842619|NCT00248612|OG000|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
10842620|NCT00248612|OG002|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
10842621|NCT00248612|EG000|Reported Event|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
10842622|NCT00248612|EG001|Reported Event|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
10842623|NCT00248612|EG002|Reported Event|Venlafaxine & PMR|Venlafaxine medication and PMR (progressive muscle relaxation therapy).
10842624|NCT00248612|EG003|Reported Event|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
10842625|NCT00248625|BG000|Baseline|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
10842626|NCT00248625|BG001|Baseline|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
10842627|NCT00248625|BG002|Baseline|Total|Total of all reporting groups
10842628|NCT00248625|FG000|Participant Flow|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications."
10842629|NCT00248625|FG001|Participant Flow|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
10972237|NCT00920231|OG000|Outcome|Initial Prototype|The initial prototype is a system that has been successfully tested in outdoor navigation and successfully tested for simple object recognition.
10972238|NCT00920231|OG001|Outcome|Modified System|this computer vision system incorporates the needed changes identified by the first group of subjects using the initial prototype system.
10972239|NCT00920231|EG000|Reported Event|Arm 1|"the blind subject is asked to locate a randomly placed object with the assistance of the webcam/laptop computer.~computer vision: a webcam-laptop based system to assist the blind in locating objects and in way finding.~No adverse events"
10972240|NCT00920231|EG001|Reported Event|Arm 2|"The subject without the assist device can only locate the object by groping and random searching with hands.~No adverse events"
10972241|NCT00920374|BG000|Baseline|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
10972242|NCT00920374|BG001|Baseline|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
10972243|NCT00920374|BG002|Baseline|Total|Total of all reporting groups
10972244|NCT00920374|FG000|Participant Flow|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
10972245|NCT00920374|FG001|Participant Flow|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
10972246|NCT00920374|OG000|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
10972247|NCT00920374|OG001|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
10972248|NCT00920374|EG000|Reported Event|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
10972249|NCT00920374|EG001|Reported Event|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
10972250|NCT00920426|BG000|Baseline|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
10972251|NCT00920426|BG001|Baseline|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
10972252|NCT00920426|BG002|Baseline|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
10972253|NCT00920426|BG003|Baseline|Total|Total of all reporting groups
10972254|NCT00920426|FG000|Participant Flow|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
10972255|NCT00920426|FG001|Participant Flow|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
10972256|NCT00920426|FG002|Participant Flow|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
10972257|NCT00920426|FG003|Participant Flow|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
10972258|NCT00920426|OG000|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
10972259|NCT00920426|OG001|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
10972260|NCT00920426|OG002|Outcome|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
10972261|NCT00920426|OG000|Outcome|GSK1265744 5 mg|Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.
10972262|NCT00920426|OG000|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg tablet once daily for 10 days.
10972263|NCT00920426|OG000|Outcome|Pooled GSK1265744|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
10972264|NCT00920426|EG000|Reported Event|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
10972265|NCT00920426|EG001|Reported Event|GSK1265744 5 mg|Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.
10972266|NCT00920426|EG002|Reported Event|Placebo|Eligible participants received double-blind Placebo matching 5 mg GSK1265744 oral tablet once daily for 10 days.
10972267|NCT00920426|EG003|Reported Event|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
10972268|NCT00920439|BG000|Baseline|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
10972269|NCT00920439|FG000|Participant Flow|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
10972270|NCT00920439|OG000|Outcome|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
10972271|NCT00920439|EG000|Reported Event|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
11312880|NCT03192150|BG000|Baseline|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312881|NCT03192150|BG001|Baseline|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312882|NCT03192150|BG002|Baseline|Total|Total of all reporting groups
11312883|NCT03192150|FG000|Participant Flow|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312884|NCT03192150|FG001|Participant Flow|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312885|NCT03192150|OG000|Outcome|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312886|NCT03192150|OG001|Outcome|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312887|NCT03192150|EG000|Reported Event|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312888|NCT03192150|EG001|Reported Event|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days.
11312889|NCT03192176|BG000|Baseline|Placebo BID|Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
11312890|NCT03192176|BG001|Baseline|Fezolinetant 15 mg BID|Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
11312891|NCT03192176|BG002|Baseline|Fezolinetant 30 mg BID|Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
11312892|NCT03192176|BG003|Baseline|Fezolinetant 60 mg BID|Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
11312893|NCT03192176|BG004|Baseline|Fezolinetant 90 mg BID|Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
11312894|NCT03192176|BG005|Baseline|Fezolinetant 30 mg QD|Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312895|NCT03192176|BG006|Baseline|Fezolinetant 60 mg QD|Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312896|NCT03192176|BG007|Baseline|Fezolinetant 120 mg QD|Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312897|NCT03192176|BG008|Baseline|Total|Total of all reporting groups
11312898|NCT03192176|FG000|Participant Flow|Placebo BID|Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks.
11312899|NCT03192176|FG001|Participant Flow|Fezolinetant 15 mg BID|Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
11312900|NCT03192176|FG002|Participant Flow|Fezolinetant 30 mg BID|Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
11312901|NCT03192176|FG003|Participant Flow|Fezolinetant 60 mg BID|Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
11312902|NCT03192176|FG004|Participant Flow|Fezolinetant 90 mg BID|Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
11312903|NCT03192176|FG005|Participant Flow|Fezolinetant 30 mg QD|Participants received fezolinetant 30 mg capsules orally, once daily (QD) and matching placebo QD for a period of 12 weeks.
10825413|NCT00096486|BG000|Baseline|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
10825414|NCT00096486|BG001|Baseline|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
11312904|NCT03192176|FG006|Participant Flow|Fezolinetant 60 mg QD|Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312905|NCT03192176|FG007|Participant Flow|Fezolinetant 120 mg QD|Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312906|NCT03192176|OG000|Outcome|Placebo BID|Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
11312907|NCT03192176|OG001|Outcome|Fezolinetant 15 mg BID|Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
11312908|NCT03192176|OG002|Outcome|Fezolinetant 30 mg BID|Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
11312909|NCT03192176|OG003|Outcome|Fezolinetant 60 mg BID|Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
10825415|NCT00096486|BG002|Baseline|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
11312910|NCT03192176|OG004|Outcome|Fezolinetant 90 mg BID|Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
11312911|NCT03192176|OG005|Outcome|Fezolinetant 30 mg QD|Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312912|NCT03192176|OG006|Outcome|Fezolinetant 60 mg QD|Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312913|NCT03192176|OG007|Outcome|Fezolinetant 120 mg QD|Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312914|NCT03192176|OG000|Outcome|Placebo|Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
11312915|NCT03192176|EG000|Reported Event|Placebo BID|Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
11312916|NCT03192176|EG001|Reported Event|Fezolinetant 15 mg BID|Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
11312917|NCT03192176|EG002|Reported Event|Fezolinetant 30 mg BID|Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
11312918|NCT03192176|EG003|Reported Event|Fezolinetant 60 mg BID|Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
10972272|NCT00920556|BG000|Baseline|Overall Study|Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited progressive disease (PD), then received bortezomib (1.3 milligram(mg)/meter square (m^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
10972273|NCT00920556|FG000|Participant Flow|Overall Study|Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
10972274|NCT00920556|OG000|Outcome|SRT501 Monotherapy|The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
10972275|NCT00920556|OG001|Outcome|SRT501 + Bortezomib|The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
10972276|NCT00920556|OG000|Outcome|SRT501 Monotherapy|The eligible participants in this arm received 5 g of SRT501, orally every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
10972277|NCT00920556|OG001|Outcome|SRT501 + Bortezomib|The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care.SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
10972278|NCT00920556|OG000|Outcome|SRT501 Monotherapy|The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.
10972279|NCT00920556|EG000|Reported Event|SRT501|The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.
10972280|NCT00920647|BG000|Baseline|Control|Untreated Patients
10972281|NCT00920647|BG001|Baseline|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972282|NCT00920647|BG002|Baseline|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972283|NCT00920647|BG003|Baseline|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972284|NCT00920647|BG004|Baseline|Total|Total of all reporting groups
10972285|NCT00920647|FG000|Participant Flow|Control|Untreated Patients
10972286|NCT00920647|FG001|Participant Flow|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972287|NCT00920647|FG002|Participant Flow|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972288|NCT00920647|FG003|Participant Flow|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972289|NCT00920647|OG000|Outcome|Control|Untreated Patients
10972290|NCT00920647|OG001|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972291|NCT00920647|OG002|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972292|NCT00920647|OG003|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972293|NCT00920647|OG000|Outcome|Control|Untreated Patients for 6 months, Observed Value
10972294|NCT00920647|OG001|Outcome|Idursulfase IT (1mg)|monthly using an intrathecal drug delivery device (IDDD)
10972295|NCT00920647|OG000|Outcome|Control|
10972296|NCT00920647|OG000|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD.
10972297|NCT00920647|OG001|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972298|NCT00920647|OG002|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972299|NCT00920647|OG000|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD) Value represents concentration at 36 hours post drug administration.
10972300|NCT00920647|OG001|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD) Value represents concentration at 24 hours post drug administration
10972301|NCT00920647|OG002|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD) Value represents concentration at 36 hours post drug administration
10972302|NCT00920647|OG000|Outcome|Control|Untreated Patients, Observed Value
10972303|NCT00920647|EG000|Reported Event|Control|Untreated Patients
10972304|NCT00920647|EG001|Reported Event|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972305|NCT00920647|EG002|Reported Event|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972306|NCT00920647|EG003|Reported Event|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
10972307|NCT00920686|BG000|Baseline|Placebo|3 x 0 mg capsules
10972308|NCT00920686|BG001|Baseline|NXN-188 600 mg|3 x 200 mg capsules
10972309|NCT00920686|BG002|Baseline|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
10972310|NCT00920686|BG003|Baseline|Total|Total of all reporting groups
10972311|NCT00920686|FG000|Participant Flow|Placebo|3 x 0 mg capsules
10972312|NCT00920686|FG001|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules
10972313|NCT00920686|FG002|Participant Flow|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
10972314|NCT00920686|OG000|Outcome|Placebo|Three capsules containing placebo
10972315|NCT00920686|OG001|Outcome|NXN-188|600 mg of NXN-188 provided as 3 x 200 mg capsules.
10972316|NCT00920686|OG002|Outcome|Sumatriptan Succinate|100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
10972317|NCT00920686|OG000|Outcome|Placebo|3 x 0 mg capsules
10972318|NCT00920686|OG001|Outcome|NXN-188 600 mg|3 x 200 mg capsules
10972319|NCT00920686|OG002|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
10972320|NCT00920686|OG002|Outcome|Sumatriptan Succinate|1 x 100 mg, 2 x 0 mg capsules
10972321|NCT00920686|EG000|Reported Event|Placebo|Three placebo capsules were provided. All capsules were taken at the same time.
10972322|NCT00920686|EG001|Reported Event|NXN-188|600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
10972323|NCT00920686|EG002|Reported Event|Sumatriptan Succinate|100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
10972324|NCT00920699|BG000|Baseline|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972325|NCT00920699|BG001|Baseline|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972326|NCT00920699|BG002|Baseline|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972327|NCT00920699|BG003|Baseline|Total|Total of all reporting groups
10972328|NCT00920699|FG000|Participant Flow|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972329|NCT00920699|FG001|Participant Flow|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972330|NCT00920699|FG002|Participant Flow|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972331|NCT00920699|OG000|Outcome|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972332|NCT00920699|OG001|Outcome|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10825416|NCT00096486|BG003|Baseline|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
10825417|NCT00096486|BG004|Baseline|Total|Total of all reporting groups
10825418|NCT00096486|FG000|Participant Flow|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
10825419|NCT00096486|FG001|Participant Flow|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
10825420|NCT00096486|FG002|Participant Flow|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
10825421|NCT00096486|FG003|Participant Flow|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
10825422|NCT00096486|OG000|Outcome|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
10825423|NCT00096486|OG001|Outcome|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
10825424|NCT00096486|OG002|Outcome|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
10825425|NCT00096486|OG003|Outcome|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
10825426|NCT00096486|EG000|Reported Event|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
10825427|NCT00096486|EG001|Reported Event|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
10825428|NCT00096486|EG002|Reported Event|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
10825429|NCT00096486|EG003|Reported Event|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
10825430|NCT00096538|BG000|Baseline|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
10825431|NCT00096538|FG000|Participant Flow|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
10825432|NCT00096538|OG000|Outcome|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
10825433|NCT00096538|EG000|Reported Event|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
10825434|NCT00096681|BG000|Baseline|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
10825435|NCT00096681|FG000|Participant Flow|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
10825436|NCT00096681|OG000|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
10825437|NCT00096681|EG000|Reported Event|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
10825438|NCT00096785|BG000|Baseline|Entecavir|ETV 0.5 mg once daily (QD)
10825439|NCT00096785|BG001|Baseline|Adefovir|ADV 10 mg QD
10825440|NCT00096785|BG002|Baseline|Total|Total of all reporting groups
10825441|NCT00096785|FG000|Participant Flow|Entecavir|ETV 0.5 mg once daily (QD)
10825442|NCT00096785|FG001|Participant Flow|Adefovir|ADV 10 mg QD
10825443|NCT00096785|OG000|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
10825444|NCT00096785|OG001|Outcome|Adefovir|ADV 10 mg QD
10825445|NCT00096785|EG000|Reported Event|ADV 10 mg|
10825446|NCT00096785|EG001|Reported Event|ETV 0.5 mg|
10825447|NCT00096941|BG000|Baseline|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
10825448|NCT00096941|FG000|Participant Flow|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
10825449|NCT00096941|OG000|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
10825450|NCT00096941|EG000|Reported Event|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
10825451|NCT00096954|BG000|Baseline|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
10825452|NCT00096954|BG001|Baseline|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
10825453|NCT00096954|BG002|Baseline|Total|Total of all reporting groups
10825454|NCT00096954|FG000|Participant Flow|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
10972333|NCT00920699|OG002|Outcome|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972334|NCT00920699|EG000|Reported Event|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972335|NCT00920699|EG001|Reported Event|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972336|NCT00920699|EG002|Reported Event|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
10972337|NCT00920790|BG000|Baseline|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
10972338|NCT00920790|FG000|Participant Flow|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
10972339|NCT00920790|OG000|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
10972340|NCT00920790|EG000|Reported Event|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
10972341|NCT00920829|BG000|Baseline|A118G A/A With Naltrexone|"Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule"
10972342|NCT00920829|BG001|Baseline|A118G A/A With Placebo|"Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks~Placebo: placebo"
10972343|NCT00920829|BG002|Baseline|A118G Any G With Naltrexone|"Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule"
10972344|NCT00920829|BG003|Baseline|A118G Any G With Placebo|"Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Placebo: placebo"
10972345|NCT00920829|BG004|Baseline|Total|Total of all reporting groups
10972346|NCT00920829|FG000|Participant Flow|A118G A/A With Naltrexone|"Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule"
10972347|NCT00920829|FG001|Participant Flow|A118G A/A With Placebo|"Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks~Placebo: placebo"
10972348|NCT00920829|FG002|Participant Flow|A118G Any G With Naltrexone|"Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule"
10972349|NCT00920829|FG003|Participant Flow|A118G Any G With Placebo|"Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Placebo: placebo"
10972350|NCT00920829|OG000|Outcome|A118G A/A With Naltrexone|"Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule"
10972351|NCT00920829|OG001|Outcome|A118G A/A With Placebo|"Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks~Placebo: placebo"
10972352|NCT00920829|OG002|Outcome|A118G Any G With Naltrexone|"Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule"
10972353|NCT00920829|OG003|Outcome|A118G Any G With Placebo|"Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks~Placebo: placebo"
10972354|NCT00920829|EG000|Reported Event|Placebo/ASN|ASN subjects given placebo
10972355|NCT00920829|EG001|Reported Event|Placebo/ASP|ASP subjects given placebo
10972356|NCT00920829|EG002|Reported Event|Naltrexone/ASN|ASN subjects given naltrexone
10972357|NCT00920829|EG003|Reported Event|Naltrexone/ASP|ASP subjects given naltrexone
10972358|NCT00920855|BG000|Baseline|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972359|NCT00920855|BG001|Baseline|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972360|NCT00920855|BG002|Baseline|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972361|NCT00920855|BG003|Baseline|Total|Total of all reporting groups
11312919|NCT03192176|EG004|Reported Event|Fezolinetant 90 mg BID|Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
10972362|NCT00920855|FG000|Participant Flow|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972363|NCT00920855|FG001|Participant Flow|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972364|NCT00920855|FG002|Participant Flow|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972365|NCT00920855|OG000|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972366|NCT00920855|OG001|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972367|NCT00920855|OG002|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972368|NCT00920855|OG000|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
10972369|NCT00920855|EG000|Reported Event|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972370|NCT00920855|EG001|Reported Event|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972371|NCT00920855|EG002|Reported Event|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
10972372|NCT00920907|BG000|Baseline|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
10972373|NCT00920907|BG001|Baseline|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
10972374|NCT00920907|BG002|Baseline|Total|Total of all reporting groups
10972375|NCT00920907|FG000|Participant Flow|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
10972376|NCT00920907|FG001|Participant Flow|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
11312920|NCT03192176|EG005|Reported Event|Fezolinetant 30 mg QD|Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
10825455|NCT00096954|FG001|Participant Flow|Placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
10972377|NCT00920907|OG000|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
10972378|NCT00920907|OG001|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
10972379|NCT00920907|OG000|Outcome|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
10972380|NCT00920907|OG001|Outcome|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
10972381|NCT00920907|EG000|Reported Event|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
10972382|NCT00920907|EG001|Reported Event|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
10972383|NCT00921024|BG000|Baseline|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
10972384|NCT00921024|BG001|Baseline|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
10972385|NCT00921024|BG002|Baseline|Total|Total of all reporting groups
10972386|NCT00921024|FG000|Participant Flow|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
10972387|NCT00921024|FG001|Participant Flow|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
10972388|NCT00921024|OG000|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
10972389|NCT00921024|OG001|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
10972390|NCT00921024|EG000|Reported Event|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
10972391|NCT00921024|EG001|Reported Event|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
10972392|NCT00921310|BG000|Baseline|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972393|NCT00921310|BG001|Baseline|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972394|NCT00921310|BG002|Baseline|Total|Total of all reporting groups
10972395|NCT00921310|FG000|Participant Flow|Phase I Dose Level 1 (Pemetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972396|NCT00921310|FG001|Participant Flow|Phase I Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972397|NCT00921310|FG002|Participant Flow|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972398|NCT00921310|OG000|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972399|NCT00921310|OG001|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972400|NCT00921310|OG000|Outcome|Phase I Dose Level 1 (Premetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972401|NCT00921310|OG001|Outcome|Phase 1 Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972402|NCT00921310|OG002|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972403|NCT00921310|OG000|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972404|NCT00921310|OG001|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972405|NCT00921310|OG001|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972406|NCT00921310|EG000|Reported Event|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
10972407|NCT00921310|EG001|Reported Event|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
10972408|NCT00921518|BG000|Baseline|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972409|NCT00921518|BG001|Baseline|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972410|NCT00921518|BG002|Baseline|Total|Total of all reporting groups
10972411|NCT00921518|FG000|Participant Flow|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
11312921|NCT03192176|EG006|Reported Event|Fezolinetant 60 mg QD|Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312922|NCT03192176|EG007|Reported Event|Fezolinetant 120 mg QD|Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
11312923|NCT03192306|BG000|Baseline|Merlin|"glycolic acid and ethanol mixture~Merlin: glycolic acid/ethanol solution"
10972412|NCT00921518|FG001|Participant Flow|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972413|NCT00921518|OG000|Outcome|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972414|NCT00921518|OG001|Outcome|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972415|NCT00921518|EG000|Reported Event|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972416|NCT00921518|EG001|Reported Event|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
10972417|NCT00921557|BG000|Baseline|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
10972418|NCT00921557|BG001|Baseline|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
10972419|NCT00921557|BG002|Baseline|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
10972420|NCT00921557|BG003|Baseline|Total|Total of all reporting groups
10972421|NCT00921557|FG000|Participant Flow|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
10972422|NCT00921557|FG001|Participant Flow|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
10972423|NCT00921557|FG002|Participant Flow|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
10972424|NCT00921557|OG000|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
10972425|NCT00921557|OG001|Outcome|2: Placebo|Participants received placebo for 48 weeks
10972426|NCT00921557|OG000|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
10972427|NCT00921557|OG001|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
10972428|NCT00921557|OG002|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
10972429|NCT00921557|OG000|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
10972430|NCT00921557|OG001|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
10972431|NCT00921557|OG002|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
10972432|NCT00921557|EG000|Reported Event|1A: Alendronate/Alendronate|Participants received alendronate for 48 weeks
10972433|NCT00921557|EG001|Reported Event|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
10972434|NCT00921557|EG002|Reported Event|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
10972435|NCT00921687|BG000|Baseline|Control Clinic|Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).
10972436|NCT00921687|BG001|Baseline|Intervention Clinic|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
10972437|NCT00921687|BG002|Baseline|Total|Total of all reporting groups
10972438|NCT00921687|FG000|Participant Flow|Control|Providers in the control group received education only (CKD lecture and a CKD reference card).
10972439|NCT00921687|FG001|Participant Flow|Intervention|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
10972440|NCT00921687|OG000|Outcome|Control Clinic|
10972441|NCT00921687|OG001|Outcome|Intervention Clinic|
10972442|NCT00921687|EG000|Reported Event|Control Clinic|
10972443|NCT00921687|EG001|Reported Event|Intervention Clinic|
10972444|NCT00921843|BG000|Baseline|Methadone 0.1mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972445|NCT00921843|BG001|Baseline|Methadone 0.2mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972446|NCT00921843|BG002|Baseline|Methadone 0.3mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972447|NCT00921843|BG003|Baseline|Control|Subjects do not receive methadone as their intraoperative opioid.
10825456|NCT00096954|OG000|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
10825457|NCT00096954|OG001|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
10825458|NCT00096954|EG000|Reported Event|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
10825459|NCT00096954|EG001|Reported Event|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
10825460|NCT00096993|BG000|Baseline|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
10825461|NCT00096993|BG001|Baseline|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
10825462|NCT00096993|BG002|Baseline|Total|Total of all reporting groups
10825463|NCT00096993|FG000|Participant Flow|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
10825464|NCT00096993|FG001|Participant Flow|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
10825465|NCT00096993|OG000|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
10825466|NCT00096993|OG001|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
10825467|NCT00096993|EG000|Reported Event|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
10825468|NCT00096993|EG001|Reported Event|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
10825469|NCT00097253|BG000|Baseline|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825470|NCT00097253|FG000|Participant Flow|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825471|NCT00097253|OG000|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825472|NCT00097253|OG001|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825473|NCT00097253|OG002|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825474|NCT00097253|OG000|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10972448|NCT00921843|BG004|Baseline|Total|Total of all reporting groups
10825475|NCT00097253|OG002|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825476|NCT00097253|EG000|Reported Event|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
10825477|NCT00097370|BG000|Baseline|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
10825478|NCT00097370|FG000|Participant Flow|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
10825479|NCT00097370|OG000|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
10825480|NCT00097370|EG000|Reported Event|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual's blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
10825481|NCT00097448|BG000|Baseline|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
10825482|NCT00097448|BG001|Baseline|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
10825483|NCT00097448|BG002|Baseline|Total|Total of all reporting groups
10825484|NCT00097448|FG000|Participant Flow|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
10825485|NCT00097448|FG001|Participant Flow|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
10825486|NCT00097448|OG000|Outcome|Oral Steroids|Prednisone
10825487|NCT00097448|OG001|Outcome|IT Steroids|methylprednisolone
10825488|NCT00097448|EG000|Reported Event|Oral Steroids|Prednisone
10825489|NCT00097448|EG001|Reported Event|IT Steroids|methylprednisolone
10825490|NCT00097500|BG000|Baseline|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
10825491|NCT00097500|BG001|Baseline|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
10825492|NCT00097500|BG002|Baseline|Total|Total of all reporting groups
10825493|NCT00097500|FG000|Participant Flow|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
10825494|NCT00097500|FG001|Participant Flow|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
10825495|NCT00097500|OG000|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
10825496|NCT00097500|OG001|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
10825497|NCT00097500|EG000|Reported Event|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
10825498|NCT00097500|EG001|Reported Event|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
10825499|NCT00097539|BG000|Baseline|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
10825500|NCT00097539|BG001|Baseline|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
10825501|NCT00097539|BG002|Baseline|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
10825502|NCT00097539|BG003|Baseline|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
10972449|NCT00921843|FG000|Participant Flow|Methadone 0.1mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972450|NCT00921843|FG001|Participant Flow|Methadone 0.2mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972451|NCT00921843|FG002|Participant Flow|Methadone 0.3mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972452|NCT00921843|FG003|Participant Flow|Control|Subjects do not receive methadone as their intraoperative opioid.
10972453|NCT00921843|OG000|Outcome|Methadone 0.1mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972454|NCT00921843|OG001|Outcome|Methadone 0.2mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972455|NCT00921843|OG002|Outcome|Methadone 0.3mg/kg|Subjects will receive methadone as their intraoperative opioid.
10972456|NCT00921843|OG003|Outcome|Control|Subjects do not receive methadone as their intraoperative opioid.
10972457|NCT00921843|EG000|Reported Event|Methadone 0.1mg/kg|"Methadone administration 0.1mg/kg~Methadone: Subjects will receive methadone as their intraoperative opioid."
10972458|NCT00921843|EG001|Reported Event|Methadone 0.2mg/kg|"Methadone administration 0.2mg/kg~Methadone: Subjects will receive methadone as their intraoperative opioid"
10972459|NCT00921843|EG002|Reported Event|Methadone 0.3g/kg|"Methadone administration 0.3 mg/kg~Methadone: Subjects will receive methadone as their intraoperative opioid"
10972460|NCT00921843|EG003|Reported Event|Control|"No methadone~No methadone: Subjects will not receive methadone as their intraoperative opioid"
10972461|NCT00921895|BG000|Baseline|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
10972462|NCT00921895|FG000|Participant Flow|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
10972463|NCT00921895|OG000|Outcome|RPS Adeno Detector IV (Sensitivity)|Looking for the number of true positives as compared to cell culture.
10972464|NCT00921895|OG001|Outcome|RPS Adeno Detector IV (Specificity)|Looking for the number of true negatives as compared to cell culture.
10972465|NCT00921895|EG000|Reported Event|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
10972466|NCT00921934|BG000|Baseline|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
10972467|NCT00921934|FG000|Participant Flow|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
10972468|NCT00921934|OG000|Outcome|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
10972469|NCT00921934|EG000|Reported Event|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
10972470|NCT00921947|BG000|Baseline|VAX102 IM|Given as 1 µg intramuscular
10972471|NCT00921947|BG001|Baseline|VAX102 SC|Given as 2 µg subcutaneous
10972472|NCT00921947|BG002|Baseline|Total|Total of all reporting groups
10972473|NCT00921947|FG000|Participant Flow|VAX102 IM|Given as 1 µg intramuscular
10972474|NCT00921947|FG001|Participant Flow|VAX102 SC|Given as 2 µg subcutaneous
10972475|NCT00921947|OG000|Outcome|VAX102 1.0 µg i.m.|
10972476|NCT00921947|OG001|Outcome|VAX102 2.0 µg s.c.|
10972477|NCT00921947|EG000|Reported Event|VAX102 IM|Given as 1 µg intramuscular
10972478|NCT00921947|EG001|Reported Event|VAX102 SC|Given as 2 µg subcutaneous
10972479|NCT00922116|BG000|Baseline|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
10972480|NCT00922116|FG000|Participant Flow|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
10972481|NCT00922116|OG000|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
10972482|NCT00922116|EG000|Reported Event|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
10972483|NCT00922194|BG000|Baseline|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
10972484|NCT00922194|FG000|Participant Flow|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
10972485|NCT00922194|OG000|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
10972486|NCT00922194|EG000|Reported Event|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
10972487|NCT00922207|BG000|Baseline|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972488|NCT00922207|BG001|Baseline|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972489|NCT00922207|BG002|Baseline|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972490|NCT00922207|BG003|Baseline|Total|Total of all reporting groups
11312924|NCT03192306|BG001|Baseline|Ethanol|Ethanol: Ethanol solution
11312925|NCT03192306|BG002|Baseline|Total|Total of all reporting groups
10972491|NCT00922207|FG000|Participant Flow|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972492|NCT00922207|FG001|Participant Flow|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972493|NCT00922207|FG002|Participant Flow|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972494|NCT00922207|OG000|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972495|NCT00922207|OG001|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972496|NCT00922207|OG002|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972497|NCT00922207|EG000|Reported Event|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972498|NCT00922207|EG001|Reported Event|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972499|NCT00922207|EG002|Reported Event|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
10972500|NCT00922233|BG000|Baseline|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
10972501|NCT00922233|FG000|Participant Flow|Levonorgestrel|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
10972502|NCT00922233|OG000|Outcome|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills
10972503|NCT00922233|OG000|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
10972504|NCT00922233|EG000|Reported Event|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
10972505|NCT00922272|BG000|Baseline|Overall|Constitutes all subjects contained in the Safety Analysis Set defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.
10972506|NCT00922272|FG000|Participant Flow|SPD489|The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication. They were then randomized into the Double-Blind Phase receiving either their optimal dose of adjunctive SPD489 or placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
10972507|NCT00922272|FG001|Participant Flow|Placebo|Subjects received placebo once-daily for 4 weeks during the Double-blind Phase to a stable dose of atypical antipsychotic medication.
10972508|NCT00922272|OG000|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
10972509|NCT00922272|OG000|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
10972510|NCT00922272|OG001|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
10972511|NCT00922272|EG000|Reported Event|SPD489 (Open-label Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
10972512|NCT00922272|EG001|Reported Event|SPD489 (Double-blind Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
10972513|NCT00922272|EG002|Reported Event|Placebo (Double-blind Phase)|Subjects receive placebo once-daily
10972514|NCT00922428|BG000|Baseline|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
10972515|NCT00922428|FG000|Participant Flow|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
10825503|NCT00097539|BG004|Baseline|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
10825504|NCT00097539|BG005|Baseline|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
10825505|NCT00097539|BG006|Baseline|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
10825506|NCT00097539|BG007|Baseline|Total|Total of all reporting groups
10825507|NCT00097539|FG000|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD)|Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection [Protropin], somatropin for injection [Nutropin, Nutropin AQ, and Nutropin Depot]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter [ng/mL], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).
10825508|NCT00097539|FG001|Participant Flow|Organic Growth Hormone Deficiency (GHD)|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
10825509|NCT00097539|FG002|Participant Flow|Idiopathic Short Stature (ISS)|Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
10825510|NCT00097539|FG003|Participant Flow|Turner Syndrome|Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
10825511|NCT00097539|FG004|Participant Flow|Renal Disease|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
10825512|NCT00097539|FG005|Participant Flow|Other Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
10825513|NCT00097539|FG006|Participant Flow|Undefined Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
10825514|NCT00097539|OG000|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
10825515|NCT00097539|OG001|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
10825516|NCT00097539|OG002|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
10825517|NCT00097539|OG003|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
10972516|NCT00922428|OG000|Outcome|Observational (Visit 1)|VAS of the observational group at beginning
10972517|NCT00922428|OG001|Outcome|Observational Group (Visit 2)|VAS of the observational group at visit 2
10972518|NCT00922428|OG002|Outcome|Observational Group (Visit 3)|VAS of the observational group at visit 3
10972519|NCT00922428|OG000|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
10972520|NCT00922428|OG000|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
10972521|NCT00922428|OG001|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
10972522|NCT00922428|OG002|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
10972523|NCT00922428|EG000|Reported Event|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
10972524|NCT00922441|BG000|Baseline|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
10972525|NCT00922441|BG001|Baseline|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
10972526|NCT00922441|BG002|Baseline|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
10972527|NCT00922441|BG003|Baseline|Total|Total of all reporting groups
10972528|NCT00922441|FG000|Participant Flow|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
10972529|NCT00922441|FG001|Participant Flow|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
10972530|NCT00922441|FG002|Participant Flow|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
10972531|NCT00922441|OG000|Outcome|Fimasartan 1-ITT|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
10972532|NCT00922441|OG001|Outcome|Fimasartan 2-ITT|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
10972533|NCT00922441|OG002|Outcome|Valsartan: Control-ITT|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
10972534|NCT00922441|EG000|Reported Event|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
10972535|NCT00922441|EG001|Reported Event|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
10972536|NCT00922441|EG002|Reported Event|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
10972537|NCT00922480|BG000|Baseline|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
10972538|NCT00922480|BG001|Baseline|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
10972539|NCT00922480|BG002|Baseline|Total|Total of all reporting groups
10972540|NCT00922480|FG000|Participant Flow|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
10972541|NCT00922480|FG001|Participant Flow|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
10972542|NCT00922480|OG000|Outcome|Control: Losartan / Week 12 -ITT|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
10972543|NCT00922480|OG001|Outcome|Test: Fimasartan / Week 12 -ITT|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
10972544|NCT00922480|OG000|Outcome|Control: Losartan / Week 4,8 -ITT|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
10972545|NCT00922480|OG001|Outcome|Test: Fimasartan / Week 4,8 -ITT|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
10972546|NCT00922480|EG000|Reported Event|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
10972547|NCT00922480|EG001|Reported Event|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
10972548|NCT00922623|BG000|Baseline|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
10972549|NCT00922623|FG000|Participant Flow|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
10972550|NCT00922623|OG000|Outcome|Belotero, Left Nasolabial Fold|Belotero injected into the Left Nasolabial Fold of the Face
10972551|NCT00922623|OG001|Outcome|Belotero, Right Nasolabial Fold|Belotero injected into the Right Nasolabial Fold of the Face
10972552|NCT00922623|EG000|Reported Event|Belotero, Left Nasolabial Fold|
10972553|NCT00922623|EG001|Reported Event|Belotero, Right Nasolabial Fold|
10972554|NCT00922636|BG000|Baseline|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
10972555|NCT00922636|BG001|Baseline|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
10972556|NCT00922636|BG002|Baseline|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972557|NCT00922636|BG003|Baseline|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972558|NCT00922636|BG004|Baseline|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972559|NCT00922636|BG005|Baseline|Total|Total of all reporting groups
10972560|NCT00922636|FG000|Participant Flow|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
10972561|NCT00922636|FG001|Participant Flow|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
10972562|NCT00922636|FG002|Participant Flow|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972563|NCT00922636|FG003|Participant Flow|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972564|NCT00922636|FG004|Participant Flow|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972565|NCT00922636|OG000|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
10972566|NCT00922636|OG001|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972567|NCT00922636|OG002|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972568|NCT00922636|OG003|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972569|NCT00922636|OG000|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
10972570|NCT00922636|EG000|Reported Event|Placebo - Treatment Phase|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase.
10972571|NCT00922636|EG001|Reported Event|LY2216684 (0.1 mg/kg/Day) - Treatment Phase|Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972572|NCT00922636|EG002|Reported Event|LY2216684 (0.2 mg/kg/Day) - Treatment Phase|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972573|NCT00922636|EG003|Reported Event|LY2216684 (0.3 mg/kg/Day) - Treatment Phase|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
10972574|NCT00922636|EG004|Reported Event|Methylphenidate - Treatment Phase|Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding.
10972575|NCT00922636|EG005|Reported Event|Placebo - Taper Phase|Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase.
10972576|NCT00922636|EG006|Reported Event|LY2216684 (0.1 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
10972577|NCT00922636|EG007|Reported Event|LY2216684 (0.2 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase.
10972578|NCT00922636|EG008|Reported Event|LY2216684 (0.3 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
10972579|NCT00922636|EG009|Reported Event|Methylphenidate - Taper Phase|Participants were given the placebo in capsule form QD po for the 2-week taper phase.
10972580|NCT00922701|BG000|Baseline|Peritoneal Dialysis Solution|The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
10972581|NCT00922701|FG000|Participant Flow|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
10972582|NCT00922701|OG000|Outcome|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
10972583|NCT00922701|EG000|Reported Event|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
10972584|NCT00922766|BG000|Baseline|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
10972585|NCT00922766|FG000|Participant Flow|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
10972586|NCT00922766|OG000|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
10972587|NCT00922766|EG000|Reported Event|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
10972588|NCT00922779|BG000|Baseline|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
10972589|NCT00922779|FG000|Participant Flow|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
10972590|NCT00922779|OG000|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
10972591|NCT00922779|EG000|Reported Event|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
10972592|NCT00922883|BG000|Baseline|Eltrombopag|Eltrombopag (Promacta): Subjects commenced eltrombopag at a dose of 50 mg, which was increased by 25 mg every 2 weeks if the platelet count had not increased by 20 × 103/µL, to a maximum dose of 150 mg.
10972593|NCT00922883|FG000|Participant Flow|Eltrombopag|Eltrombopag (Promacta): Subjects commenced eltrombopag at a dose of 50 mg, which was increased by 25 mg every 2 weeks if the platelet count had not increased by 20 × 103/µL, to a maximum dose of 150 mg.
10972594|NCT00922883|OG000|Outcome|Eltrombopag|Eltrombopag (Promacta): Subjects commenced eltrombopag at a dose of 50 mg, which was increased by 25 mg every 2 weeks if the platelet count had not increased by 20 × 103/µL, to a maximum dose of 150 mg.
10972595|NCT00922883|EG000|Reported Event|Eltrombopag|Eltrombopag (Promacta): Subjects commenced eltrombopag at a dose of 50 mg, which was increased by 25 mg every 2 weeks if the platelet count had not increased by 20 × 103/µL, to a maximum dose of 150 mg.
10972596|NCT00922935|BG000|Baseline|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
10972597|NCT00922935|BG001|Baseline|Cresco Late Loading|"Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before try ins to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery."
10972598|NCT00922935|BG002|Baseline|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
10972599|NCT00922935|BG003|Baseline|Total|Total of all reporting groups
10972600|NCT00922935|FG000|Participant Flow|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
10972601|NCT00922935|FG001|Participant Flow|Cresco Late Loading|"Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before try ins to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery."
10972602|NCT00922935|FG002|Participant Flow|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
10972603|NCT00922935|OG000|Outcome|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
10972604|NCT00922935|OG001|Outcome|Cresco Late Loading|"Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before try ins to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery."
11312926|NCT03192306|FG000|Participant Flow|Merlin|"glycolic acid and ethanol mixture~Merlin: glycolic acid/ethanol solution"
10972605|NCT00922935|OG002|Outcome|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
10972606|NCT00922935|EG000|Reported Event|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
10972607|NCT00922935|EG001|Reported Event|Cresco Late Loading|"Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before try ins to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery."
10972608|NCT00922935|EG002|Reported Event|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
10972609|NCT00922974|BG000|Baseline|Radiosurgery/SBRT (Phase II)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
11312927|NCT03192306|FG001|Participant Flow|Ethanol|Ethanol: Ethanol solution
11312928|NCT03192306|OG000|Outcome|Merlin|"glycolic acid and ethanol mixture~Merlin: glycolic acid/ethanol solution"
11312929|NCT03192306|OG001|Outcome|Ethanol|Ethanol: Ethanol solution
10972610|NCT00922974|BG001|Baseline|Radiosurgery/SBRT (Phase III)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
10972611|NCT00922974|BG002|Baseline|External Beam Radiation Therapy|Single fraction dose of 8 Gy external beam radiation therapy
10972612|NCT00922974|BG003|Baseline|Total|Total of all reporting groups
10972613|NCT00922974|FG000|Participant Flow|Radiosurgery/SBRT|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
10972614|NCT00922974|FG001|Participant Flow|External Beam Radiation Therapy|Single fraction dose of 8 Gy external beam radiation therapy
10972615|NCT00922974|OG000|Outcome|Radiosurgery/SBRT (Phase II)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
10972616|NCT00922974|OG000|Outcome|Radiosurgery/SBRT (Phase III)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
10972617|NCT00922974|OG001|Outcome|External Beam Radiation Therapy|Single fraction dose of 8 Gy external beam radiation therapy
10972618|NCT00922974|EG000|Reported Event|Radiosurgery/SBRT (Phase II)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
10972619|NCT00922974|EG001|Reported Event|Radiosurgery/SBRT (Phase III)|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
10972620|NCT00922974|EG002|Reported Event|External Beam Radiation Therapy|Single fraction dose of 8 Gy external beam radiation therapy
10972621|NCT00922987|BG000|Baseline|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
10972622|NCT00922987|FG000|Participant Flow|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
10972623|NCT00922987|OG000|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
10972624|NCT00922987|EG000|Reported Event|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
10972625|NCT00923078|BG000|Baseline|Auditory-Visual Train Order|N = 20 participants with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness) followed by 4 weeks (20 sessions) of visual training (Insight)
10972626|NCT00923078|BG001|Baseline|Visual-Auditory Train Order|N = 20 participants with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight) followed by 4 weeks (20 sessions) of auditory training (Brain Fitness)
10972627|NCT00923078|BG002|Baseline|Healthy Comparison|N = 20 healthy community volunteers participated in a single test session to provide normative comparison data
10972628|NCT00923078|BG003|Baseline|Total|Total of all reporting groups
10972629|NCT00923078|FG000|Participant Flow|Auditory Then Visual Cognitive Training|20 individuals with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness) followed by 4 weeks (20 sessions) of visual training (Insight).
10972630|NCT00923078|FG001|Participant Flow|Visual Then Auditory Cognitive Training|20 individuals with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight) followed by 4 weeks (20 sessions) of auditory training (Brain Fitness).
10972631|NCT00923078|FG002|Participant Flow|Healthy Comparison|A sample healthy community volunteers participated in a single test session to provide normative comparison data on neurophysiological (P300, MMN) outcome measures
10972632|NCT00923078|OG000|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
10972633|NCT00923078|OG001|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
10972634|NCT00923078|EG000|Reported Event|Auditory Cognitive Training|Individuals with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness)
10972635|NCT00923078|EG001|Reported Event|Visual Cognitive Training|Individuals with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight)
10972636|NCT00923078|EG002|Reported Event|Healthy Comparison|N = 20 healthy community volunteers participated in a single test session to provide normative comparison data
10972637|NCT00923091|BG000|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
10972638|NCT00923091|BG001|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
10972639|NCT00923091|BG002|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
10972640|NCT00923091|BG003|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
10972641|NCT00923091|BG004|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
10972642|NCT00923091|BG005|Baseline|Olmesartan/Amlodipine 20mg/5mg|
10972643|NCT00923091|BG006|Baseline|Olmesartan/Amlodipine 40mg/5mg|
10972644|NCT00923091|BG007|Baseline|Olmesartan/Amlodipine 40mg/10mg|
10972645|NCT00923091|BG008|Baseline|Total|Total of all reporting groups
10972646|NCT00923091|FG000|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group.
11312930|NCT03192306|EG000|Reported Event|Merlin|"glycolic acid and ethanol mixture~Merlin: glycolic acid/ethanol solution"
11312931|NCT03192306|EG001|Reported Event|Ethanol|Ethanol: Ethanol solution
10825518|NCT00097539|OG004|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
10825519|NCT00097539|OG005|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
10825520|NCT00097539|OG006|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
10825521|NCT00097539|EG000|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
10825522|NCT00097539|EG001|Reported Event|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
10825523|NCT00097539|EG002|Reported Event|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
10825524|NCT00097539|EG003|Reported Event|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
10825525|NCT00097539|EG004|Reported Event|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
10825526|NCT00097539|EG005|Reported Event|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
10825527|NCT00097539|EG006|Reported Event|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
10825528|NCT00097591|BG000|Baseline|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
10825529|NCT00097591|BG001|Baseline|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
10825530|NCT00097591|BG002|Baseline|Total|Total of all reporting groups
10825531|NCT00097591|FG000|Participant Flow|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
10825532|NCT00097591|FG001|Participant Flow|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
10825533|NCT00097591|OG000|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
10825534|NCT00097591|OG001|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
10825535|NCT00097591|EG000|Reported Event|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
10825536|NCT00097591|EG001|Reported Event|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
10825537|NCT00097669|BG000|Baseline|Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)|"Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.~Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin"
10825538|NCT00097669|BG001|Baseline|Placebo Tablet|Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
10825539|NCT00097669|BG002|Baseline|Total|Total of all reporting groups
10825540|NCT00097669|FG000|Participant Flow|Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)|"Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.~Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin"
10825541|NCT00097669|FG001|Participant Flow|Placebo Tablet|Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
10825542|NCT00097669|OG000|Outcome|Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)|"Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.~Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin"
10825543|NCT00097669|OG001|Outcome|Placebo Tablet|Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
10825544|NCT00097669|EG000|Reported Event|Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)|"Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.~Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin"
10825545|NCT00097669|EG001|Reported Event|Placebo Tablet|Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
10825546|NCT00097695|BG000|Baseline|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
10825547|NCT00097695|BG001|Baseline|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
10825548|NCT00097695|BG002|Baseline|Controlled Open-label / Laryngeal Attack|patients who received first treatment Open-Label due to laryngeal symptoms
10825549|NCT00097695|BG003|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
10825550|NCT00097695|BG004|Baseline|Total|Total of all reporting groups
10825551|NCT00097695|FG000|Participant Flow|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
10825552|NCT00097695|FG001|Participant Flow|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
10825553|NCT00097695|FG002|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
10825554|NCT00097695|FG003|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
10825555|NCT00097695|OG000|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
10825556|NCT00097695|OG001|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
10825557|NCT00097695|OG000|Outcome|Randomized Control Trial-icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
10825558|NCT00097695|OG001|Outcome|Randomized Control Trial-placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
10825559|NCT00097695|EG000|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase.
10825560|NCT00097695|EG001|Reported Event|Controlled Phase- Placebo (Randomized Subjects|Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
10825561|NCT00097695|EG002|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
10825562|NCT00097695|EG003|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
10825563|NCT00097695|EG004|Reported Event|Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase.
10825564|NCT00097695|EG005|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline)|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
10825565|NCT00097708|BG000|Baseline|OROS Alprazolam|
10825566|NCT00097708|BG001|Baseline|IR Alprazolam|
10825567|NCT00097708|BG002|Baseline|Placebo|
10825568|NCT00097708|BG003|Baseline|Total|Total of all reporting groups
10825569|NCT00097708|FG000|Participant Flow|OROS Alprazolam|OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
10825570|NCT00097708|FG001|Participant Flow|IR Alprazolam|IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
10825571|NCT00097708|FG002|Participant Flow|Placebo|OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.
10825572|NCT00097708|OG000|Outcome|OROS Alprazolam|
10825573|NCT00097708|OG001|Outcome|IR Alprazolam|
10825574|NCT00097708|OG002|Outcome|Placebo|
10825575|NCT00097708|EG000|Reported Event|OROS Alprazolam|
10825576|NCT00097708|EG001|Reported Event|IR Alprazolam|
10825577|NCT00097708|EG002|Reported Event|Placebo|
10825578|NCT00097721|BG000|Baseline|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10825579|NCT00097721|BG001|Baseline|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10972647|NCT00923091|FG001|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group.
10972648|NCT00923091|FG002|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972649|NCT00923091|FG003|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972650|NCT00923091|FG004|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972651|NCT00923091|FG005|Participant Flow|Olmesartan(OM)20mg/Amlodipine (AML)5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972652|NCT00923091|FG006|Participant Flow|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972653|NCT00923091|FG007|Participant Flow|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
10972654|NCT00923091|FG008|Participant Flow|OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg|In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
10972655|NCT00923091|FG009|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
10972656|NCT00923091|FG010|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
10972657|NCT00923091|FG011|Participant Flow|OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
10972658|NCT00923091|FG012|Participant Flow|20/5/12.5mg Responder Continued on 20/5/12.5 mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
10972659|NCT00923091|OG000|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
10972660|NCT00923091|OG001|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
10972661|NCT00923091|OG002|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
10972662|NCT00923091|OG003|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
10972663|NCT00923091|OG004|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
10972664|NCT00923091|OG005|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
10972665|NCT00923091|OG006|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
10972666|NCT00923091|OG007|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
10972667|NCT00923091|OG000|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
10825580|NCT00097721|BG002|Baseline|Total|Total of all reporting groups
10972668|NCT00923091|OG001|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.~Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
10972669|NCT00923091|OG001|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
10972670|NCT00923091|OG000|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
10972671|NCT00923091|OG001|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
10972672|NCT00923091|OG001|Outcome|OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
10972673|NCT00923091|OG000|Outcome|OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25|The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
10972674|NCT00923091|EG000|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
10972675|NCT00923091|EG001|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
10972676|NCT00923091|EG002|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
10972677|NCT00923091|EG003|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
10972678|NCT00923091|EG004|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
10972679|NCT00923091|EG005|Reported Event|Olmesartan/Amlodipine 20mg/5mg|
10972680|NCT00923091|EG006|Reported Event|Olmesartan/Amlodipine 40mg/5mg|
10972681|NCT00923091|EG007|Reported Event|Olmesartan/Amlodipine 40mg/10mg|
10972682|NCT00923117|BG000|Baseline|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
10972683|NCT00923117|BG001|Baseline|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
10972684|NCT00923117|BG002|Baseline|Total|Total of all reporting groups
10972685|NCT00923117|FG000|Participant Flow|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
10972686|NCT00923117|FG001|Participant Flow|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
10972687|NCT00923117|OG000|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
10972688|NCT00923117|OG001|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
10972689|NCT00923117|EG000|Reported Event|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
10972690|NCT00923117|EG001|Reported Event|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
10972691|NCT00923130|BG000|Baseline|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
10972692|NCT00923130|FG000|Participant Flow|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
10972693|NCT00923130|OG000|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
10972694|NCT00923130|EG000|Reported Event|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
10972695|NCT00923156|BG000|Baseline|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
10825581|NCT00097721|FG000|Participant Flow|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10825582|NCT00097721|FG001|Participant Flow|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10825583|NCT00097721|OG000|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10825584|NCT00097721|OG001|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10825585|NCT00097721|EG000|Reported Event|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10825586|NCT00097721|EG001|Reported Event|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10825587|NCT00097773|BG000|Baseline|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
10825588|NCT00097773|BG001|Baseline|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
10825589|NCT00097773|BG002|Baseline|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
10825590|NCT00097773|BG003|Baseline|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
10825591|NCT00097773|BG004|Baseline|Total|Total of all reporting groups
10825592|NCT00097773|FG000|Participant Flow|Cycled TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
10825593|NCT00097773|FG001|Participant Flow|Cycled TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
10825594|NCT00097773|FG002|Participant Flow|Culture-Based TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
10825595|NCT00097773|FG003|Participant Flow|Culture-Based TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
10825596|NCT00097773|OG000|Outcome|Cycled TIS|Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
10825597|NCT00097773|OG001|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
10825598|NCT00097773|OG002|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
10825599|NCT00097773|OG003|Outcome|Oral Placebo|Pooled oral placebo group
10825600|NCT00097773|OG000|Outcome|Cycled TIS|Pooled Cycled TIS group
10825601|NCT00097773|OG001|Outcome|Culture-Based TIS|Pooled Culture-Based TIS group
10825602|NCT00097773|OG002|Outcome|Oral Cipro|Pooled oral cipro group
10825603|NCT00097773|OG003|Outcome|Oral Placebo|pooled oral placebo group
10825604|NCT00097773|OG000|Outcome|Cycled TIS|Pooled Cycled TIS therapy group
10825605|NCT00097773|EG000|Reported Event|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
10825606|NCT00097773|EG001|Reported Event|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
10825607|NCT00097773|EG002|Reported Event|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
10825608|NCT00097773|EG003|Reported Event|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
10825609|NCT00097786|BG000|Baseline|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
10825610|NCT00097786|BG001|Baseline|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
10825611|NCT00097786|BG002|Baseline|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
10825612|NCT00097786|BG003|Baseline|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
10825613|NCT00097786|BG004|Baseline|Total|Total of all reporting groups
10825614|NCT00097786|FG000|Participant Flow|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
10825615|NCT00097786|FG001|Participant Flow|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
10825616|NCT00097786|FG002|Participant Flow|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
10972696|NCT00923156|BG001|Baseline|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
10972697|NCT00923156|BG002|Baseline|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
10972698|NCT00923156|BG003|Baseline|Total|Total of all reporting groups
10972699|NCT00923156|FG000|Participant Flow|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
10972700|NCT00923156|FG001|Participant Flow|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
10972701|NCT00923156|FG002|Participant Flow|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
10972702|NCT00923156|OG000|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
10972703|NCT00923156|OG001|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
10972704|NCT00923156|OG002|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
10972705|NCT00923156|EG000|Reported Event|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
10972706|NCT00923156|EG001|Reported Event|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
10972707|NCT00923156|EG002|Reported Event|Ramipril + Aliskiren|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
10972708|NCT00923195|BG000|Baseline|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
11312932|NCT03192475|BG000|Baseline|GLB Plus Phone Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months~GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving."
10825617|NCT00097786|FG003|Participant Flow|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
10972709|NCT00923195|BG001|Baseline|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972710|NCT00923195|BG002|Baseline|Total|Total of all reporting groups
10972711|NCT00923195|FG000|Participant Flow|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972712|NCT00923195|FG001|Participant Flow|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972713|NCT00923195|OG000|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972714|NCT00923195|OG001|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972715|NCT00923195|EG000|Reported Event|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972716|NCT00923195|EG001|Reported Event|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
10972717|NCT00923260|BG000|Baseline|Roux-en-Y Gastric Bypass/Omentectomy|
10972718|NCT00923260|BG001|Baseline|Roux-en-Y Gastric Bypass Alone|
10972719|NCT00923260|BG002|Baseline|Total|Total of all reporting groups
10972720|NCT00923260|FG000|Participant Flow|Roux-en-Y Gastric Bypass/Omentectomy|
10825618|NCT00097786|OG000|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
10825619|NCT00097786|OG001|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
10972721|NCT00923260|FG001|Participant Flow|Roux-en-Y Gastric Bypass Alone|
10972722|NCT00923260|OG000|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
10972723|NCT00923260|OG001|Outcome|Roux-en-Y Gastric Bypass Alone|
10972724|NCT00923260|EG000|Reported Event|Roux-en-Y Gastric Bypass/Omentectomy|
10972725|NCT00923260|EG001|Reported Event|Roux-en-Y Gastric Bypass Alone|
10972726|NCT00923273|BG000|Baseline|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
10972727|NCT00923273|BG001|Baseline|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
10972728|NCT00923273|BG002|Baseline|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
10972729|NCT00923273|BG003|Baseline|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
10972730|NCT00923273|BG004|Baseline|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
10972731|NCT00923273|BG005|Baseline|Total|Total of all reporting groups
10972732|NCT00923273|FG000|Participant Flow|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
10972733|NCT00923273|FG001|Participant Flow|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
10972734|NCT00923273|FG002|Participant Flow|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
10972735|NCT00923273|FG003|Participant Flow|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
10972736|NCT00923273|FG004|Participant Flow|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
10972737|NCT00923273|OG000|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
10972738|NCT00923273|OG001|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
10972739|NCT00923273|OG002|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
10972740|NCT00923273|OG003|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
10972741|NCT00923273|OG004|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
10972742|NCT00923273|OG000|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
10972743|NCT00923273|OG001|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
10972744|NCT00923273|OG002|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
10972745|NCT00923273|OG003|Outcome|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
10972746|NCT00923273|OG004|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
10972747|NCT00923273|OG000|Outcome|Treatment Level 4: 10mg Load|"Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2~Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I"
10825620|NCT00097786|OG000|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
10825621|NCT00097786|OG001|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
10972748|NCT00923273|EG000|Reported Event|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
10972749|NCT00923273|EG001|Reported Event|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
10972750|NCT00923273|EG002|Reported Event|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
10972751|NCT00923273|EG003|Reported Event|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
10972752|NCT00923273|EG004|Reported Event|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
10972753|NCT00923351|BG000|Baseline|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
10972754|NCT00923351|BG001|Baseline|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
10972755|NCT00923351|BG002|Baseline|Total|Total of all reporting groups
10972756|NCT00923351|FG000|Participant Flow|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participant will receive Tumor lysate/keyhole limpet hemocyanin (KLH) pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
11312933|NCT03192475|BG001|Baseline|GLB Plus Newsletter Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.~GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only."
10972757|NCT00923351|FG001|Participant Flow|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose subcutaneous (SQ) (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
10972758|NCT00923351|FG002|Participant Flow|Enrolled But Not Assigned to Treatment|Twelve participants were not treated in Arm A or Arm B because they did not get far enough in the study to be designated for an Arm. Were unable to obtain apheresis, and adequate tumor samples.
10972759|NCT00923351|OG000|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
10972760|NCT00923351|OG001|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
10972761|NCT00923351|EG000|Reported Event|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
10972762|NCT00923351|EG001|Reported Event|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
10972763|NCT00923364|BG000|Baseline|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2~Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)~Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
10972764|NCT00923364|FG000|Participant Flow|Recipients|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2~Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)~Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
10972765|NCT00923364|FG001|Participant Flow|Healthy Related Donors|
10972766|NCT00923364|OG000|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
10972767|NCT00923364|OG000|Outcome|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
10972768|NCT00923364|EG000|Reported Event|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
10972769|NCT00923481|BG000|Baseline|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
10972770|NCT00923481|FG000|Participant Flow|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
10972771|NCT00923481|OG000|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
10972772|NCT00923481|EG000|Reported Event|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
10972773|NCT00923559|BG000|Baseline|Mother-Infant Psychoanalytic Treatment;MIP|MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety.
10972774|NCT00923559|BG001|Baseline|TAU at Child Health Centres|Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.
10972775|NCT00923559|BG002|Baseline|Total|Total of all reporting groups
10972776|NCT00923559|FG000|Participant Flow|Mother-Infant Psychoanalytic Treatment;MIP|MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety.
10972777|NCT00923559|FG001|Participant Flow|TAU at Child Health Centres|Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.
10972778|NCT00923559|OG000|Outcome|Mother-Infant Psychoanalytic Treatment;MIP|A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety.
10972779|NCT00923559|OG001|Outcome|Treatment as Usual at Child Health Centre|Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
10972780|NCT00923559|OG001|Outcome|Treatment as Usual at Child Health Centres|Treatment as usual with nurse visits at Child HEalth Centres as part of regular Swedish child health care.
10972781|NCT00923559|OG000|Outcome|Mother-infant Psychoanalytic Treatment; MIP|A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety.
11312934|NCT03192475|BG002|Baseline|Total|Total of all reporting groups
10972782|NCT00923559|EG000|Reported Event|Mother-Infant Psychoanalytic Treatment;MIP|MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety.
10972783|NCT00923559|EG001|Reported Event|TAU at Child Health Centres|Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.
10972784|NCT00923598|BG000|Baseline|1) 0.1% Ropivicaine on Right Leg|"Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972785|NCT00923598|BG001|Baseline|2) 0.4% Ropivicaine on Right Leg|"Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972786|NCT00923598|BG002|Baseline|Total|Total of all reporting groups
10972787|NCT00923598|FG000|Participant Flow|1) 0.1% Ropivicaine on Right Leg|"Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972788|NCT00923598|FG001|Participant Flow|2) 0.4% Ropivicaine on Right Leg|"Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972789|NCT00923598|OG000|Outcome|1) 0.1% Ropivicaine on Right Leg|"Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972790|NCT00923598|OG001|Outcome|2) 0.4% Ropivicaine on Right Leg|"Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972791|NCT00923598|EG000|Reported Event|1) 0.1% Ropivicaine on Right Leg|"Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
11312935|NCT03192475|FG000|Participant Flow|GLB Plus Phone Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months~GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving."
10825622|NCT00097786|EG000|Reported Event|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
10825623|NCT00097786|EG001|Reported Event|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
10825624|NCT00097786|EG002|Reported Event|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
10825625|NCT00097786|EG003|Reported Event|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
10825626|NCT00097981|BG000|Baseline|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825627|NCT00097981|BG001|Baseline|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825628|NCT00097981|BG002|Baseline|Total|Total of all reporting groups
10825629|NCT00097981|FG000|Participant Flow|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825630|NCT00097981|FG001|Participant Flow|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825631|NCT00097981|OG000|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825632|NCT00097981|OG001|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825633|NCT00097981|EG000|Reported Event|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825634|NCT00097981|EG001|Reported Event|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
10825635|NCT00098020|BG000|Baseline|Isotretinoin|subjects will be treated with iIsotretinoin.
10825636|NCT00098020|FG000|Participant Flow|Isotretinoin|"Subjects will be treated with isotretinoin initially at 1mg/kg for the first 4 weeks and then dose will escalate to a higher dose only if subjects have tolerated the lower dose.~In younger patients of 16 and 17 years of age, the dose will be started at 1 mg/kg and will remain at this dose without escalation."
10825637|NCT00098020|OG000|Outcome|Isotretinoin|oral isotretinoin
10825638|NCT00098020|EG000|Reported Event|Isotretinoin|Subjects will be treated with isotretinoin .
10825639|NCT00098059|BG000|Baseline|Part A (Single-dose of Famciclovir)|Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
10825640|NCT00098059|BG001|Baseline|Part B (Multiple-dose of Famciclovir)|Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
10825641|NCT00098059|BG002|Baseline|Total|Total of all reporting groups
10825642|NCT00098059|FG000|Participant Flow|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
10825643|NCT00098059|FG001|Participant Flow|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
10825644|NCT00098059|OG000|Outcome|1 to < 2 Years|
10825645|NCT00098059|OG001|Outcome|2 to <6 Years|
10825646|NCT00098059|OG002|Outcome|6 to <13 Years|
10825647|NCT00098059|OG003|Outcome|13 to <=18 Years|
10825648|NCT00098059|OG002|Outcome|6 to <=12 Years|
10825649|NCT00098059|OG003|Outcome|13 to <= 18 Years|
10825650|NCT00098059|OG003|Outcome|13 to < =18 Years|
10825651|NCT00098059|EG000|Reported Event|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
10825652|NCT00098059|EG001|Reported Event|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
10825653|NCT00098254|BG000|Baseline|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
10825654|NCT00098254|FG000|Participant Flow|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
10825655|NCT00098254|OG000|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
10825656|NCT00098254|EG000|Reported Event|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
10825657|NCT00098293|BG000|Baseline|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit.
10825658|NCT00098293|BG001|Baseline|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
10825659|NCT00098293|BG002|Baseline|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
10825660|NCT00098293|BG003|Baseline|Total|Total of all reporting groups
10825661|NCT00098293|FG000|Participant Flow|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit.
10825662|NCT00098293|FG001|Participant Flow|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
10825663|NCT00098293|FG002|Participant Flow|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
10842630|NCT00248625|OG000|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
10825664|NCT00098293|FG003|Participant Flow|Maraviroc Twice Daily + CBV (OL)|Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
10825665|NCT00098293|FG004|Participant Flow|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
10825666|NCT00098293|OG000|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
10825667|NCT00098293|OG001|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
10825668|NCT00098293|OG002|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
10825669|NCT00098293|OG000|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
10825670|NCT00098293|OG001|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
10825671|NCT00098293|EG000|Reported Event|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
10825672|NCT00098293|EG001|Reported Event|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
10825673|NCT00098293|EG002|Reported Event|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
10825674|NCT00098293|EG003|Reported Event|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
10825675|NCT00098306|BG000|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825676|NCT00098306|BG001|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825677|NCT00098306|BG002|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825678|NCT00098306|BG003|Baseline|Total|Total of all reporting groups
10825679|NCT00098306|FG000|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825680|NCT00098306|FG001|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825681|NCT00098306|FG002|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825682|NCT00098306|FG003|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825683|NCT00098306|FG004|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
10825684|NCT00098306|FG005|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825685|NCT00098306|FG006|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825686|NCT00098306|OG000|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825687|NCT00098306|OG001|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825688|NCT00098306|OG002|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825689|NCT00098306|OG000|Outcome|Maraviroc QD|Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825690|NCT00098306|EG000|Reported Event|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825691|NCT00098306|EG001|Reported Event|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825692|NCT00098306|EG002|Reported Event|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825693|NCT00098306|EG003|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825694|NCT00098306|EG004|Reported Event|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
10825695|NCT00098306|EG005|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825696|NCT00098306|EG006|Reported Event|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825697|NCT00098345|BG000|Baseline|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
10825698|NCT00098345|FG000|Participant Flow|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
10825699|NCT00098345|OG000|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
10825700|NCT00098345|EG000|Reported Event|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
10825701|NCT00098371|BG000|Baseline|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
10825702|NCT00098371|FG000|Participant Flow|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 & 22) to three (days 1, 8, and 15).
10825703|NCT00098371|OG000|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
10825704|NCT00098371|OG000|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
10825705|NCT00098371|OG000|Outcome|Group 1|Patients without dexamethasone
10825706|NCT00098371|OG001|Outcome|Group 2|Patients with dexamethasone
10825707|NCT00098371|OG000|Outcome|Patients With Del(17p13.1)|
10825708|NCT00098371|OG001|Outcome|Patients Without Del(17p13.1)|
10825709|NCT00098371|OG002|Outcome|Patients With Del(11q22.3)|
10825710|NCT00098371|OG003|Outcome|Patients Without Del(11q22.3)|
10825711|NCT00098371|OG004|Outcome|Patients With Complex Karyotype|Complex Karyotype defined as three or more cytogenetic aberrations.
10825712|NCT00098371|OG005|Outcome|Patients Without Complex Karyotype|Complex Karyotype defined as fewer than three cytogenetic aberrations.
10825713|NCT00098371|OG000|Outcome|Responders|Patients who achieved a partial response (PR)
10825714|NCT00098371|OG001|Outcome|Non-Responders|Patients who had stable disease (SD) or progressive disease (PD)
10825715|NCT00098371|EG000|Reported Event|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
10825716|NCT00098670|BG000|Baseline|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
10825717|NCT00098670|FG000|Participant Flow|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
10825718|NCT00098670|OG000|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
10825719|NCT00098670|EG000|Reported Event|FR Induction|Fludarabine and rituximab induction in pts with B-cell CLL
10825720|NCT00098670|EG001|Reported Event|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction
10825721|NCT00098722|BG000|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825722|NCT00098722|BG001|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825723|NCT00098722|BG002|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825724|NCT00098722|BG003|Baseline|Total|Total of all reporting groups
10825725|NCT00098722|FG000|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825726|NCT00098722|FG001|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825727|NCT00098722|FG002|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10972792|NCT00923598|EG001|Reported Event|2) 0.4% Ropivicaine on Right Leg|"Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.~0.1% and 0.4% perineural ropivicaine: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery."
10972793|NCT00923845|BG000|Baseline|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
10972794|NCT00923845|BG001|Baseline|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
10972795|NCT00923845|BG002|Baseline|Total|Total of all reporting groups
10972796|NCT00923845|FG000|Participant Flow|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
10972797|NCT00923845|FG001|Participant Flow|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
10972798|NCT00923845|OG000|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
10972799|NCT00923845|OG000|Outcome|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
10972800|NCT00923845|OG001|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
10972801|NCT00923845|EG000|Reported Event|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
10972802|NCT00923845|EG001|Reported Event|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
10972803|NCT00923910|BG000|Baseline|Donors|Donor lymphocyte collection via apheresis.
10972804|NCT00923910|BG001|Baseline|Recipients|Vaccine and donor lymphocyte prep
10972805|NCT00923910|BG002|Baseline|Total|Total of all reporting groups
10972806|NCT00923910|FG000|Participant Flow|Donors|Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
10972807|NCT00923910|FG001|Participant Flow|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
10972808|NCT00923910|OG000|Outcome|Recipients|Vaccine and donor lymphocyte prep
10972809|NCT00923910|OG000|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
10972810|NCT00923910|EG000|Reported Event|Recipients|Vaccine and donor lymphocyte prep
10972811|NCT00923936|BG000|Baseline|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972812|NCT00923936|BG001|Baseline|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972813|NCT00923936|BG002|Baseline|Total|Total of all reporting groups
10972814|NCT00923936|FG000|Participant Flow|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972815|NCT00923936|FG001|Participant Flow|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972816|NCT00923936|OG000|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972817|NCT00923936|OG001|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10825728|NCT00098722|FG003|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825729|NCT00098722|FG004|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825730|NCT00098722|FG005|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825731|NCT00098722|FG006|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825732|NCT00098722|OG000|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825733|NCT00098722|OG001|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825734|NCT00098722|OG002|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825735|NCT00098722|EG000|Reported Event|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
10825736|NCT00098722|EG001|Reported Event|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825737|NCT00098722|EG002|Reported Event|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
10825738|NCT00098722|EG003|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825739|NCT00098722|EG004|Reported Event|In Study-off Drug, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
10825740|NCT00098722|EG005|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825741|NCT00098722|EG006|Reported Event|In Study-off Drug, Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
10825742|NCT00098748|BG000|Baseline|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
10825743|NCT00098748|BG001|Baseline|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
10825744|NCT00098748|BG002|Baseline|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
10825745|NCT00098748|BG003|Baseline|Total|Total of all reporting groups
10825746|NCT00098748|FG000|Participant Flow|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
10825747|NCT00098748|FG001|Participant Flow|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
10972818|NCT00923936|OG000|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972819|NCT00923936|OG000|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972820|NCT00923936|EG000|Reported Event|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972821|NCT00923936|EG001|Reported Event|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
10972822|NCT00923949|BG000|Baseline|Pioglitazone|45 mg tablet daily by mouth for six weeks
10972823|NCT00923949|FG000|Participant Flow|Pioglitazone|45 mg tablet daily by mouth for six weeks
10972824|NCT00923949|OG000|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
10972825|NCT00923949|EG000|Reported Event|Pioglitazone|45 mg tablet daily by mouth for six weeks
10972826|NCT00923975|BG000|Baseline|Intended Users of the Software|Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
10972827|NCT00923975|FG000|Participant Flow|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
10972828|NCT00923975|OG000|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
10972829|NCT00923975|EG000|Reported Event|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
10972830|NCT00924001|BG000|Baseline|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
10972831|NCT00924001|FG000|Participant Flow|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
10972832|NCT00924001|OG000|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
10972833|NCT00924001|EG000|Reported Event|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
10972834|NCT00924040|BG000|Baseline|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
10972835|NCT00924040|FG000|Participant Flow|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
10972836|NCT00924040|OG000|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
10972837|NCT00924040|EG000|Reported Event|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
10972838|NCT00924053|BG000|Baseline|Placebo|Received 1, 3, or 6 placebo capsules once daily.
10972839|NCT00924053|BG001|Baseline|EGT0001474 25 mg|Received one 25 mg capsule once daily.
10972840|NCT00924053|BG002|Baseline|EGT0001474 75 mg|Received three 25mg capsules once daily.
10972841|NCT00924053|BG003|Baseline|EGT0001474 150mg|Received six 25 mg capsules once daily.
10972842|NCT00924053|BG004|Baseline|Total|Total of all reporting groups
10972843|NCT00924053|FG000|Participant Flow|Placebo|Received 1, 3, or 6 placebo capsules once daily.
10972844|NCT00924053|FG001|Participant Flow|EGT0001474 25 mg|Received one 25 mg capsule once daily.
10972845|NCT00924053|FG002|Participant Flow|EGT0001474 75 mg|Received three 25mg capsules once daily.
10972846|NCT00924053|FG003|Participant Flow|EGT0001474 150mg|Received six 25 mg capsules once daily.
10972847|NCT00924053|OG000|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
10972848|NCT00924053|OG001|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
10972849|NCT00924053|OG002|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
10972850|NCT00924053|OG003|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
10972851|NCT00924053|EG000|Reported Event|Placebo|Received 1, 3, or 6 placebo capsules once daily.
10972852|NCT00924053|EG001|Reported Event|EGT0001474 25 mg|Received one 25 mg capsule once daily.
10972853|NCT00924053|EG002|Reported Event|EGT0001474 75 mg|Received three 25mg capsules once daily.
10972854|NCT00924053|EG003|Reported Event|EGT0001474 150mg|Received six 25 mg capsules once daily.
10972855|NCT00924066|BG000|Baseline|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
10972856|NCT00924066|FG000|Participant Flow|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
10972857|NCT00924066|OG000|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
10972858|NCT00924066|OG000|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
10972859|NCT00924066|EG000|Reported Event|Adverse Events for Squamous and Non-squamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
10972860|NCT00924118|BG000|Baseline|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
10972861|NCT00924118|BG001|Baseline|Open Control|Subjects randomized to open control will receive no experimental therapy.
10972862|NCT00924118|BG002|Baseline|Total|Total of all reporting groups
10972863|NCT00924118|FG000|Participant Flow|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
10972864|NCT00924118|FG001|Participant Flow|Open Control|Subjects randomized to open control will receive no experimental therapy.
10972865|NCT00924118|OG000|Outcome|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
10972866|NCT00924118|OG001|Outcome|Open Control|Subjects randomized to open control will receive no experimental therapy.
10972867|NCT00924118|EG000|Reported Event|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
10972868|NCT00924118|EG001|Reported Event|Open Control|Subjects randomized to open control will receive no experimental therapy.
10972869|NCT00924209|BG000|Baseline|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
10972870|NCT00924209|FG000|Participant Flow|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
10972871|NCT00924209|OG000|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
10972872|NCT00924209|EG000|Reported Event|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
10972873|NCT00924287|BG000|Baseline|Metastatic Cancer|Cancer that has invaded other parts of the body
10972874|NCT00924287|FG000|Participant Flow|Metastatic Cancer|Cancer that has invaded other parts of the body
10972875|NCT00924287|OG000|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
10972876|NCT00924287|EG000|Reported Event|Metastatic Cancer|Cancer that has invaded other parts of the body
10972877|NCT00924313|BG000|Baseline|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
10972878|NCT00924313|FG000|Participant Flow|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
10972879|NCT00924313|OG000|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
10972880|NCT00924313|EG000|Reported Event|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
10972881|NCT00924352|BG000|Baseline|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2."
10972882|NCT00924352|FG000|Participant Flow|Phase I|The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
10972883|NCT00924352|FG001|Participant Flow|Phase II|The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
10972884|NCT00924352|OG000|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2."
10972885|NCT00924352|OG000|Outcome|Ixabepilone + Dasatinib (Dose Level 0)|Dasatinib 100 mg daily and Ixabepilone 16 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
10972886|NCT00924352|OG001|Outcome|Ixabepilone + Dasatinib (Dose Level 1)|Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
10972887|NCT00924352|OG002|Outcome|Ixabepilone + Dasatinib (Dose Level 2)|Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
10972888|NCT00924352|EG000|Reported Event|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2."
10972889|NCT00924404|BG000|Baseline|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
10972890|NCT00924404|BG001|Baseline|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
10972891|NCT00924404|BG002|Baseline|Total|Total of all reporting groups
10972892|NCT00924404|FG000|Participant Flow|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
10972893|NCT00924404|FG001|Participant Flow|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
10972894|NCT00924404|OG000|Outcome|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
10972895|NCT00924404|OG001|Outcome|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
10972896|NCT00924404|EG000|Reported Event|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
10972897|NCT00924404|EG001|Reported Event|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
10972898|NCT00924443|BG000|Baseline|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
10972899|NCT00924443|FG000|Participant Flow|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
10972900|NCT00924443|OG000|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
10972901|NCT00924443|EG000|Reported Event|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
10972902|NCT00924469|BG000|Baseline|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
10972903|NCT00924469|BG001|Baseline|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
10972904|NCT00924469|BG002|Baseline|Total|Total of all reporting groups
10972905|NCT00924469|FG000|Participant Flow|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
10972906|NCT00924469|FG001|Participant Flow|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
10972907|NCT00924469|OG000|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
10972908|NCT00924469|OG001|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
10972909|NCT00924469|EG000|Reported Event|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
10972910|NCT00924469|EG001|Reported Event|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
10972911|NCT00924482|BG000|Baseline|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
10972912|NCT00924482|FG000|Participant Flow|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
10972913|NCT00924482|OG000|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
10972914|NCT00924482|OG000|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
10972915|NCT00924482|EG000|Reported Event|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
10972916|NCT00924508|BG000|Baseline|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
10972917|NCT00924508|FG000|Participant Flow|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
10972918|NCT00924508|OG000|Outcome|Hydrogel Patch|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
10972919|NCT00924508|OG001|Outcome|TAC 0.1%|Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
10972920|NCT00924508|OG002|Outcome|Patch + TAC|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
10972921|NCT00924508|OG000|Outcome|Hydrogel Patch Alone, TAC 0.1%, TAC + Patch|"This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.~occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone"
10972922|NCT00924508|EG000|Reported Event|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
10972923|NCT00924560|BG000|Baseline|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
10972924|NCT00924560|BG001|Baseline|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
10972925|NCT00924560|BG002|Baseline|Untreated Control|Participants received no oral contraceptives during the study.
10972926|NCT00924560|BG003|Baseline|Total|Total of all reporting groups
10972927|NCT00924560|FG000|Participant Flow|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
10972928|NCT00924560|FG001|Participant Flow|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
10972929|NCT00924560|FG002|Participant Flow|Untreated Control|Participants received no oral contraceptives during the study.
10972930|NCT00924560|OG000|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
10972931|NCT00924560|OG001|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
10972932|NCT00924560|OG002|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
10972933|NCT00924560|OG000|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
10972934|NCT00924560|OG001|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
10972935|NCT00924560|EG000|Reported Event|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
10972936|NCT00924560|EG001|Reported Event|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
10972937|NCT00924560|EG002|Reported Event|Untreated Control|Participants received no oral contraceptives during the study.
10972938|NCT00924612|BG000|Baseline|All Study Participants|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state (Treatment A) and followed by a dose-associated breakfast meal comprised of ~800 calories consisting of very low fat (6-10% fat, Treatment B), low fat (20% fat, Treatment C), normal diet (30% fat, Treatment D) and high fat (50% fat, Treatment E). Participants were randomized to one of the 4 treatment sequences (ABCDE, BDCEA, CBEDA, OR DBAEC).~Oral testosterone undecanoate (containing 300 mg T)"
10972939|NCT00924612|FG000|Participant Flow|Sequence ABCDE|"Fasting (Treatment A) followed by dose-associated breakfast meals comprised of ~ 800 calories consisting of very low fat (6-10% fat; Treatment B), low fat (20% fat; Treatment C), normal diet (30% fat; Treatment D), and high fat (50% fat; Treatment E).~Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days."
10972940|NCT00924612|FG001|Participant Flow|Sequence BDCEA|"Dose-associated breakfast meals comprised of ~ 800 calories consisting of very low fat (6-10% fat; Treatment B), followed by normal diet (30% fat; Treatment D), low fat (20% fat; Treatment C), high fat (50% fat; Treatment E) and fasting (Treatment A).~Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days."
10972941|NCT00924612|FG002|Participant Flow|Sequence CBEDA|"Dose-associated breakfast meals comprised of ~ 800 calories consisting of low fat (20% fat; Treatment C), followed by very low fat (6-10% fat; Treatment B), high fat (50% fat; Treatment E) normal diet (30% fat; Treatment D), and fasting (Treatment A).~Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days."
10972942|NCT00924612|FG003|Participant Flow|Sequence DBAEC|"Dose-associated breakfast meals comprised of ~ 800 calories consisting of normal diet (30% fat; Treatment D), followed by very low fat (6-10% fat; Treatment B), fasting (Treatment A), high fat (50% fat; Treatment E) and low fat (20% fat; Treatment C), Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days."
10972943|NCT00924612|OG000|Outcome|Fasting|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state~Oral testosterone undecanoate (containing 300 mg T)"
10972944|NCT00924612|OG001|Outcome|Very Low Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972945|NCT00924612|OG002|Outcome|Low Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972946|NCT00924612|OG003|Outcome|Normal Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972947|NCT00924612|OG004|Outcome|High Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972948|NCT00924612|EG000|Reported Event|Fasting|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state~Oral testosterone undecanoate (containing 300 mg T)"
10972949|NCT00924612|EG001|Reported Event|Very Low Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972950|NCT00924612|EG002|Reported Event|Low Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972951|NCT00924612|EG003|Reported Event|Normal Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972952|NCT00924612|EG004|Reported Event|High Fat Diet|"Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat).~Oral testosterone undecanoate (containing 300 mg T)"
10972953|NCT00924638|BG000|Baseline|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
10972954|NCT00924638|BG001|Baseline|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
10972955|NCT00924638|BG002|Baseline|Total|Total of all reporting groups
10972956|NCT00924638|FG000|Participant Flow|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
10972957|NCT00924638|FG001|Participant Flow|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
10972958|NCT00924638|OG000|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
10972959|NCT00924638|OG001|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
10972960|NCT00924638|EG000|Reported Event|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
10972961|NCT00924638|EG001|Reported Event|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
10972962|NCT00924651|BG000|Baseline|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
10972963|NCT00924651|BG001|Baseline|Standard Care|Wait list control
10972964|NCT00924651|BG002|Baseline|Total|Total of all reporting groups
10972965|NCT00924651|FG000|Participant Flow|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
10972966|NCT00924651|FG001|Participant Flow|Standard Care|Wait list control
10972967|NCT00924651|OG000|Outcome|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
10972968|NCT00924651|OG001|Outcome|Standard Care|Wait list control
10972969|NCT00924651|EG000|Reported Event|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
10972970|NCT00924651|EG001|Reported Event|Standard Care|Wait list control
10972971|NCT00924664|BG000|Baseline|Tanezumab 10 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.
10972972|NCT00924664|BG001|Baseline|Tanezumab 20 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
10972973|NCT00924664|BG002|Baseline|Total|Total of all reporting groups
10972974|NCT00924664|FG000|Participant Flow|Tanezumab 10 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.
10972975|NCT00924664|FG001|Participant Flow|Tanezumab 20 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
10972976|NCT00924664|OG000|Outcome|Tanezumab 10 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.
10972977|NCT00924664|OG001|Outcome|Tanezumab 20 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
10972978|NCT00924664|EG000|Reported Event|Tanezumab 10 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval.
10972979|NCT00924664|EG001|Reported Event|Tanezumab 20 mg|Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval.
10972980|NCT00924703|BG000|Baseline|rAvPAL-PEG|rAvPAL-PEG 0.001 to a maximum dose of 5.0 mg/kg/week or 375 mg/week by subcutaneous injection
10972981|NCT00924703|FG000|Participant Flow|rAvPAL-PEG|rAvPAL-PEG 0.001 to a maximum dose of 5.0 mg/kg/week or 375 mg/week by subcutaneous injection
10972982|NCT00924703|OG000|Outcome|rAvPAL-PEG|rAvPAL-PEG 0.001 to a maximum dose of 5.0 mg/kg/week or 375 mg/week by subcutaneous injection
10972983|NCT00924703|EG000|Reported Event|rAvPAL-PEG|rAvPAL-PEG 0.001 to a maximum dose of 5.0 mg/kg/week or 375 mg/week by subcutaneous injection
10972984|NCT00924729|BG000|Baseline|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972985|NCT00924729|BG001|Baseline|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972986|NCT00924729|BG002|Baseline|Total|Total of all reporting groups
10972987|NCT00924729|FG000|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972988|NCT00924729|FG001|Participant Flow|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972989|NCT00924729|OG000|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972990|NCT00924729|OG001|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972991|NCT00924729|OG000|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|Moxifloxacin 0.5% ophthalmic solution: Administer moxifloxacin study drug prior to cataract surgery.
10972992|NCT00924729|OG001|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|Besifloxacin 0.6% ophthalmic suspension: Administer besifloxacin study drug prior to cataract surgery.
10972993|NCT00924729|EG000|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972994|NCT00924729|EG001|Reported Event|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
10972995|NCT00924781|BG000|Baseline|MK2578 1mcg/600U QW|MK2578 IV administered QW.
10972996|NCT00924781|BG001|Baseline|MK2578 1mcg/600U QM|MK2578 IV administered QM.
10972997|NCT00924781|BG002|Baseline|MK2578 1mcg/350U QW|MK2578 IV administered QW.
10972998|NCT00924781|BG003|Baseline|MK2578 1mcg/350U QM|MK2578 IV administered QM.
10972999|NCT00924781|BG004|Baseline|Total|Total of all reporting groups
10973000|NCT00924781|FG000|Participant Flow|MK2578 1mcg/600 U or 1 mcg/350 U QW|MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
10973001|NCT00924781|FG001|Participant Flow|MK2578 1mcg/600 U or 1 mg/350 U QM|MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
10973002|NCT00924781|OG000|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
10973003|NCT00924781|OG001|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
10973004|NCT00924781|OG002|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
10973005|NCT00924781|OG003|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
10973006|NCT00924781|OG000|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
10973007|NCT00924781|OG001|Outcome|MK2578 1mcg/600 QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
10973008|NCT00924781|OG003|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM.Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
10973009|NCT00924781|OG002|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every U of Epogen (epoetin alpha) received per week at Baseline.
10973010|NCT00924781|OG000|Outcome|MK2578 1mcg/600U QW|MK3578 IV was administered QW. Participants were randomized to receive 1 mcg of MK-2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
10973011|NCT00924781|OG001|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
10973012|NCT00924781|OG002|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
10973013|NCT00924781|OG003|Outcome|MK-2578 1mcg/350U QM|MK2578 IV was administered QM. Participatns were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alpha) received per 4 weeks at Baseline.
10973014|NCT00924781|EG000|Reported Event|MK2578 QW|MK2578 IV administered once weekly.
10973015|NCT00924781|EG001|Reported Event|MK2578 QM|MK2578 IV administered once every 4 weeks.
10973016|NCT00924820|BG000|Baseline|Bevacizumab|Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
10973017|NCT00924820|FG000|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
10973018|NCT00924820|OG000|Outcome|Bevacizumab|Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
10973019|NCT00924820|EG000|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
10973020|NCT00924885|BG000|Baseline|Thin Follicle Aspiration Needle|Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue
10973021|NCT00924885|BG001|Baseline|Standard Follicle Aspiration Needle|Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
10973022|NCT00924885|BG002|Baseline|Total|Total of all reporting groups
10973023|NCT00924885|FG000|Participant Flow|Thin Follicle Aspiration Needle|Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue
10973024|NCT00924885|FG001|Participant Flow|Standard Follicle Aspiration Needle|Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
10973025|NCT00924885|OG000|Outcome|Thin Follicle Aspiration Needle|Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue
10973026|NCT00924885|OG001|Outcome|Standard Follicle Aspiration Needle|Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
10973027|NCT00924885|OG000|Outcome|Thin Follicle Aspiration Needle|"Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.~Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue"
10973028|NCT00924885|OG001|Outcome|Standard Follicle Aspiration Needle|"Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle.~The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.~Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue"
10973029|NCT00924885|EG000|Reported Event|Thin Follicle Aspiration Needle|Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue
10973030|NCT00924885|EG001|Reported Event|Standard Follicle Aspiration Needle|Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
10973031|NCT00924898|BG000|Baseline|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
10973032|NCT00924898|FG000|Participant Flow|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
10973033|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <200 copies/mL prior to or at week 24
10973034|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <50 copies/mL prior at week 48
10973035|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Participants who remained on study with viral suppression at week 96
10973036|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Acute HIV infection treatment group
10973037|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Baseline resistance testing was performed on all participants at enrollment.
10973038|NCT00924898|OG000|Outcome|Acute HIV Infection Treatment Group|Participants who remained on treatment at designated time points.
10973039|NCT00924898|EG000|Reported Event|Acute HIV Infection Treatment Group|Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
10973040|NCT00924950|BG000|Baseline|Ointment + Patch vs. Ointment Alone|
10973041|NCT00924950|FG000|Participant Flow|Ointment + Patch vs. Ointment Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
10973042|NCT00924950|OG000|Outcome|Taclonex Ointment Occluded With Hydrogel Patch|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
10973043|NCT00924950|OG001|Outcome|Taclonex Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
10973044|NCT00924950|OG000|Outcome|Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily|"Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily.~Taclonex Ointment and Hydrogel Patch: Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks."
10973045|NCT00924950|OG001|Outcome|Taclonex Ointment Topically Once Daily|Taclonex Ointment: Taclonex ointment daily for one psoriatic plaque.
10973046|NCT00924950|EG000|Reported Event|Ointment + Patch vs. Ointment Alone|
10973047|NCT00925002|BG000|Baseline|Val30Met: Tafamidis Then Tafamidis|Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973048|NCT00925002|BG001|Baseline|Val30Met: Placebo Then Tafamidis|Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973049|NCT00925002|BG002|Baseline|NonVal30Met: Tafamidis|NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973050|NCT00925002|BG003|Baseline|Total|Total of all reporting groups
10973051|NCT00925002|FG000|Participant Flow|Val30Met: Tafamidis Then Tafamidis|Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973052|NCT00925002|FG001|Participant Flow|Val30Met: Placebo Then Tafamidis|Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973053|NCT00925002|FG002|Participant Flow|NonVal30Met: Tafamidis|NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973054|NCT00925002|OG000|Outcome|Val30Met: Tafamidis Then Tafamidis|Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973055|NCT00925002|OG001|Outcome|Val30Met: Placebo Then Tafamidis|Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973056|NCT00925002|OG000|Outcome|NonVal30Met: Tafamidis|NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973057|NCT00925002|OG002|Outcome|NonVal30Met: Tafamidis|NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973058|NCT00925002|EG000|Reported Event|Val30Met: Tafamidis Then Tafamidis|Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973059|NCT00925002|EG001|Reported Event|Val30Met: Placebo Then Tafamidis|Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973060|NCT00925002|EG002|Reported Event|NonVal30Met: Tafamidis|NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.
10973061|NCT00925015|BG000|Baseline|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
10973062|NCT00925015|BG001|Baseline|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
10973063|NCT00925015|BG002|Baseline|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
10973064|NCT00925015|BG003|Baseline|Total|Total of all reporting groups
10973065|NCT00925015|FG000|Participant Flow|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
10973066|NCT00925015|FG001|Participant Flow|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
10973067|NCT00925015|FG002|Participant Flow|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
10973068|NCT00925015|OG000|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
10973069|NCT00925015|OG001|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
10973070|NCT00925015|OG002|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
10973071|NCT00925015|OG000|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
10973072|NCT00925015|OG001|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
10973073|NCT00925015|OG000|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
10973074|NCT00925015|OG001|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
10973075|NCT00925015|EG000|Reported Event|Cetux/Irin - Dalotuzumab 10 mg/Kg|After treatment with Cetux and Irin, Dmab was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
10973076|NCT00925015|EG001|Reported Event|Cetux/Irin - Dalotuzumab 15/7.5 mg/Kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long.
10973077|NCT00925015|EG002|Reported Event|Dalotuzumab 10 mg/Kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long.
10973078|NCT00925054|BG000|Baseline|Starting Dose=0.001 mg/kg|Subjects will start on rAvPAL-PEG 0.001 mg/kg
10973079|NCT00925054|BG001|Baseline|Starting Dose=0.003 mg/kg|Subjects will start on rAvPAL-PEG 0.003 mg/kg
10973080|NCT00925054|BG002|Baseline|Starting Dose=0.01 mg/kg|Subjects will start on rAvPAL-PEG 0.01 mg/kg
10973081|NCT00925054|BG003|Baseline|Starting Dose=0.03 mg/kg|Subjects will start on rAvPAL-PEG 0.03 mg/kg
10973082|NCT00925054|BG004|Baseline|Starting Dose=0.1 mg/kg|Subjects will start on rAvPAL-PEG 0.1 mg/kg
10973083|NCT00925054|BG005|Baseline|Total|Total of all reporting groups
10973084|NCT00925054|FG000|Participant Flow|Starting Dose=0.001 mg/kg|Subjects will start on rAvPAL-PEG 0.001 mg/kg
10973085|NCT00925054|FG001|Participant Flow|Starting Dose=0.003 mg/kg|Subjects will start on rAvPAL-PEG 0.003 mg/kg
10973086|NCT00925054|FG002|Participant Flow|Starting Dose=0.01 mg/kg|Subjects will start on rAvPAL-PEG 0.01 mg/kg
10973087|NCT00925054|FG003|Participant Flow|Starting Dose=0.03 mg/kg|Subjects will start on rAvPAL-PEG 0.03 mg/kg
10973088|NCT00925054|FG004|Participant Flow|Starting Dose=0.1 mg/kg|Subjects will start on rAvPAL-PEG 0.1 mg/kg
10973089|NCT00925054|OG000|Outcome|Starting Dose=0.001 mg/kg|Subjects with starting Dose=0.001 mg/kg
10973090|NCT00925054|OG001|Outcome|Starting Dose=0.003 mg/kg|Subjects with starting Dose=0.003 mg/kg
10973091|NCT00925054|OG002|Outcome|Starting Dose=0.01 mg/kg|Subjects with starting Dose=0.01 mg/kg
10973092|NCT00925054|OG003|Outcome|Starting Dose=0.03 mg/kg|Subjects with starting Dose=0.03 mg/kg
10973093|NCT00925054|OG004|Outcome|Starting Dose =0.1 mg/kg|Subjects with starting Dose =0.1 mg/kg
10973094|NCT00925054|OG005|Outcome|Total|All subjects with different starting dose combined
10973095|NCT00925054|EG000|Reported Event|Starting Dose=0.001 mg/kg|Subjects will start on rAvPAL-PEG 0.001 mg/kg
10973096|NCT00925054|EG001|Reported Event|Starting Dose=0.003 mg/kg|Subjects will start on rAvPAL-PEG 0.003 mg/kg
10973097|NCT00925054|EG002|Reported Event|Starting Dose=0.01 mg/kg|Subjects will start on rAvPAL-PEG 0.01 mg/kg
10973098|NCT00925054|EG003|Reported Event|Starting Dose=0.03 mg/kg|Subjects will start on rAvPAL-PEG 0.03 mg/kg
10973099|NCT00925054|EG004|Reported Event|Starting Dose=0.1 mg/kg|Subjects will start on rAvPAL-PEG 0.1 mg/kg
10973100|NCT00925119|BG000|Baseline|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
10973101|NCT00925119|FG000|Participant Flow|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
10973102|NCT00925119|OG000|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
10973103|NCT00925119|EG000|Reported Event|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
10973104|NCT00925132|BG000|Baseline|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation.~Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
10973105|NCT00925132|FG000|Participant Flow|Phase I:Decitabine 0.1mg/kg + Panobinostat 10mg + Temozolomide|Cohort 1: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 10mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973106|NCT00925132|FG001|Participant Flow|Phase I:Decitabine 0.1 mg/kg + Panobinostat 20mg +Temozolomide|Cohort 2: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973107|NCT00925132|FG002|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 20mg+Temozolomide|Cohort 3: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973108|NCT00925132|FG003|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 30mg +Temozolomide|Cohort 4: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973109|NCT00925132|FG004|Participant Flow|Phase II:Decitabine 0.2 mg/kg+Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973110|NCT00925132|OG000|Outcome|Phase I Dose Escalation|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
10973111|NCT00925132|OG000|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg +Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973112|NCT00925132|OG000|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
10973113|NCT00925132|EG000|Reported Event|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation.~Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
10973114|NCT00925288|BG000|Baseline|Regular Schedule|Duration: 0,2,6 months
10973115|NCT00925288|BG001|Baseline|Modified Schedule|Duration: 0,3,6 months
10973116|NCT00925288|BG002|Baseline|Total|Total of all reporting groups
10973117|NCT00925288|FG000|Participant Flow|Regular Schedule|Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
10973118|NCT00925288|FG001|Participant Flow|Modified Schedule|Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
10973119|NCT00925288|OG000|Outcome|Regular Schedule|Duration: 0,2,6 months
10973120|NCT00925288|OG001|Outcome|Modified Schedule|Duration: 0,3,6 months
10973121|NCT00925288|OG000|Outcome|Regular Schedule|Participants in 0,2,6 month study arm
10973122|NCT00925288|OG001|Outcome|Modified Schedule|Participants in 0,3,6 month study arm
10973123|NCT00925288|EG000|Reported Event|Regular Schedule|Duration: 0,2,6 months
10973124|NCT00925288|EG001|Reported Event|Modified Schedule|Duration: 0,3,6 months
10973125|NCT00925301|BG000|Baseline|Migalastat-Migalastat|Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1), during the 6-month open-label treatment period (Stage 2), and for up to 12 months during the OLE.
10973126|NCT00925301|BG001|Baseline|Placebo-Migalastat|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2) and for up to 12 months during the OLE.
10973127|NCT00925301|BG002|Baseline|Total|Total of all reporting groups
10973128|NCT00925301|FG000|Participant Flow|Migalastat (0-6 Months)|Migalastat hydrochloride (migalastat) 150-milligram (mg) capsule (equivalent to 123 mg of migalastat) given orally every other day (QOD) during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
10973129|NCT00925301|FG001|Participant Flow|Placebo (0-6 Months)|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
10973130|NCT00925301|FG002|Participant Flow|Migalastat (>6-12 Months)|Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
10973131|NCT00925301|FG003|Participant Flow|Migalastat (>12-24 Months)|Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
10973132|NCT00925301|OG000|Outcome|Migalastat|Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
10973133|NCT00925301|OG001|Outcome|Placebo|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1).
10973134|NCT00925301|OG000|Outcome|Migalastat-Migalastat|Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1), during the 6-month open-label treatment period (Stage 2), and for up to 12 months during the OLE.
10973135|NCT00925301|OG001|Outcome|Placebo-Migalastat|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2) and for up to 12 months during the OLE.
10973136|NCT00925301|OG000|Outcome|Placebo-Migalastat|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2).
10973137|NCT00925301|EG000|Reported Event|Migalastat (0-6 Months)|Migalastat 150-mg capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
10973138|NCT00925301|EG001|Reported Event|Placebo (0-6 Months)|Placebo capsule given orally QOD during the 6-month, double-blind, randomized placebo-controlled treatment period (Stage 1). After Stage 1, participants progressed to Stage 2 where they received open-label migalastat for 6 months.
10973139|NCT00925301|EG002|Reported Event|All Migalastat (>6-12 Months)|Migalastat 150-mg capsule given orally QOD during the 6-month open-label treatment period (Stage 2). Includes all participants who progressed from both the migalastat (0-6 Months) and the placebo (0-6 Months) Stage 1 treatment groups. After Stage 2, participants were eligible to enter the optional, 12-month OLE.
10973140|NCT00925301|EG003|Reported Event|All Migalastat (>12-24 Months)|Migalastat 150-mg capsule given orally QOD for up to 12 months during the optional OLE. Includes all participants who decided to continue treatment after completing the 6-month, open-label Stage 2 treatment period.
10973141|NCT00925353|BG000|Baseline|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
10973142|NCT00925353|FG000|Participant Flow|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
10973143|NCT00925353|OG000|Outcome|Lidocaine Gel Group|Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
10973144|NCT00925353|EG000|Reported Event|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
10973145|NCT00925522|BG000|Baseline|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids."
10973146|NCT00925522|FG000|Participant Flow|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the cat"
10973147|NCT00925522|OG000|Outcome|Therapy Cool Path Duo Catheter|All patients received RF (radio frequency) therapy from ablation catheter.
10973148|NCT00925522|EG000|Reported Event|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the catheter in the hospital environment."
10973149|NCT00925587|BG000|Baseline|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
10973150|NCT00925587|BG001|Baseline|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
10973151|NCT00925587|BG002|Baseline|Total|Total of all reporting groups
10973152|NCT00925587|FG000|Participant Flow|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
10973153|NCT00925587|FG001|Participant Flow|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
10973154|NCT00925587|OG000|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
10973155|NCT00925587|OG001|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
10973156|NCT00925587|EG000|Reported Event|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
10973157|NCT00925587|EG001|Reported Event|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
10973158|NCT00925600|BG000|Baseline|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
10973159|NCT00925600|BG001|Baseline|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
10825748|NCT00098748|FG002|Participant Flow|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
10973160|NCT00925600|BG002|Baseline|Total|Total of all reporting groups
10973161|NCT00925600|FG000|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
10973162|NCT00925600|FG001|Participant Flow|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
10973163|NCT00925600|OG000|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
10973164|NCT00925600|OG001|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
10973165|NCT00925600|OG000|Outcome|Placebo - Left Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
10973166|NCT00925600|OG001|Outcome|Placebo - Right Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
10973167|NCT00925600|OG002|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
10973168|NCT00925600|OG003|Outcome|Denosumab - Right Eye|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
10973169|NCT00925600|EG000|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
10973170|NCT00925600|EG001|Reported Event|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
11092659|NCT01541215|OG000|Outcome|Liraglutide 1.8 mg|After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
11092660|NCT01541215|OG001|Outcome|Placebo|After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
11092661|NCT01541215|OG000|Outcome|Liraglutide 1.8 mg: Follow-up 1|Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
11092662|NCT01541215|OG000|Outcome|Liraglutide 1.8 mg: Follow-up 1 and 2|Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at weeks 104 and 156.
11092663|NCT01541215|EG000|Reported Event|Liraglutide 1.8 mg|After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being >6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
11092664|NCT01541215|EG001|Reported Event|Placebo|After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
11092665|NCT01541215|EG002|Reported Event|Liraglutide 1.8 mg: Follow-up 1|Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 104.
11092666|NCT01541215|EG003|Reported Event|Liraglutide 1.8 mg: Follow-up 2|Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52), were followed-up at week 156.
11092667|NCT01541254|BG000|Baseline|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
11092668|NCT01541254|FG000|Participant Flow|Single Arm|"Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)~Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)"
11092669|NCT01541254|OG000|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
11092670|NCT01541254|EG000|Reported Event|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
11092671|NCT01541358|BG000|Baseline|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|
11092672|NCT01541358|FG000|Participant Flow|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
11092673|NCT01541358|OG000|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
11092674|NCT01541358|OG000|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
11092675|NCT01541358|EG000|Reported Event|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients undergo fluorine F 18 sodium fluoride PET/CT scan.~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan~positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan"
11092676|NCT01541371|BG000|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
10973171|NCT00925704|BG000|Baseline|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
10973172|NCT00925704|BG001|Baseline|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
10973173|NCT00925704|BG002|Baseline|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
10973174|NCT00925704|BG003|Baseline|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
10973175|NCT00925704|BG004|Baseline|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
10973176|NCT00925704|BG005|Baseline|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
10973177|NCT00925704|BG006|Baseline|Total|Total of all reporting groups
10973178|NCT00925704|FG000|Participant Flow|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
10973179|NCT00925704|FG001|Participant Flow|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
10973180|NCT00925704|FG002|Participant Flow|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
10973181|NCT00925704|FG003|Participant Flow|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
10973182|NCT00925704|FG004|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
10973183|NCT00925704|FG005|Participant Flow|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
10973184|NCT00925704|OG000|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of AUC 0-48 Lanthanum carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
10973185|NCT00925704|OG001|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of AUC 0-48 Sevelamer carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
10973186|NCT00925704|OG000|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of Cmax Lanthanum carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
10973187|NCT00925704|OG001|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of Cmax Sevelamer carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
10973188|NCT00925704|OG000|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the median of Tmax Lanthanum carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
10973189|NCT00925704|OG001|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the median of Tmax Sevelamer carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
10973190|NCT00925704|EG000|Reported Event|Lanthanum Carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
10973191|NCT00925704|EG001|Reported Event|Sevelamer Carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
10973192|NCT00925704|EG002|Reported Event|Calcitriol Alone|Calcitriol (1.0 microgram) single dose at lunch
10973193|NCT00925756|BG000|Baseline|Maraviroc Intensification|"Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications~Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment"
10973194|NCT00925756|FG000|Participant Flow|Maraviroc Intensification|"Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications~Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment"
10973195|NCT00925756|OG000|Outcome|Maraviroc Intensification|"Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications~Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment"
10973196|NCT00925756|EG000|Reported Event|Maraviroc Intensification|"Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications~Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment"
10973197|NCT00925769|BG000|Baseline|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (Dose levels [DL]-1, 2, 3, 4, 5 and 6) were administered either oral 100 mg or 150 mg of erlotinib tablet daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973198|NCT00925769|FG000|Participant Flow|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 milligrams (mg) of erlotinib (ERL) tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 milligrams per kilogram (mg/kg) of bevacizumab (BEV) intravenous (IV) infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 milligrams per square meter (mg/m^2) of capecitabine (CAP) tablet twice daily (BID) within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973199|NCT00925769|FG001|Participant Flow|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973200|NCT00925769|FG002|Participant Flow|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973201|NCT00925769|FG003|Participant Flow|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973202|NCT00925769|FG004|Participant Flow|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973203|NCT00925769|FG005|Participant Flow|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973204|NCT00925769|OG000|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973205|NCT00925769|OG000|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973206|NCT00925769|OG000|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973207|NCT00925769|OG001|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973208|NCT00925769|OG002|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
11092677|NCT01541371|FG000|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
10973209|NCT00925769|OG003|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973210|NCT00925769|OG004|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973211|NCT00925769|OG005|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973212|NCT00925769|EG000|Reported Event|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973213|NCT00925769|EG001|Reported Event|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973214|NCT00925769|EG002|Reported Event|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973215|NCT00925769|EG003|Reported Event|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973216|NCT00925769|EG004|Reported Event|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973217|NCT00925769|EG005|Reported Event|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
10973218|NCT00925782|BG000|Baseline|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
10973219|NCT00925782|FG000|Participant Flow|Melphalan - Alkeran|"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
10973220|NCT00925782|FG001|Participant Flow|Alkeran - Melphalan|"Randomized group of Alkeran-Melphalan~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
10973221|NCT00925782|OG000|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
10973222|NCT00925782|OG001|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
10973223|NCT00925782|OG000|Outcome|Open-label, Randomized, Cross-over Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
10973224|NCT00925782|OG000|Outcome|Open-label, Randomized, Crossover Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
10973225|NCT00925782|EG000|Reported Event|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
10973226|NCT00925899|BG000|Baseline|Melatonin, Then Placebo|Melatonin then placebo: 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then 1 week placebo.
10973227|NCT00925899|BG001|Baseline|Placebo. Then Melatonin|Placebo then melatonin: Placebo tablet orally every evening about one hour before bedtime for one week. Then one week melatonin 20 mg orally.
10973228|NCT00925899|BG002|Baseline|Total|Total of all reporting groups
10973229|NCT00925899|FG000|Participant Flow|Part 1: Melatonin, Then Placebo|"First one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week.~Then one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week."
10973230|NCT00925899|FG001|Participant Flow|Part 1: Placebo, Then Melatonin|"First one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week.~Then one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week."
10973231|NCT00925899|OG000|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
10973232|NCT00925899|OG001|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
10973233|NCT00925899|OG000|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between
10973234|NCT00925899|EG000|Reported Event|Melatonin Then Placebo|Melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then placebo for one week.
10973235|NCT00925899|EG001|Reported Event|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg. for one week.
10973236|NCT00925938|BG000|Baseline|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
10973237|NCT00925938|BG001|Baseline|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
10973238|NCT00925938|BG002|Baseline|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
10973239|NCT00925938|BG003|Baseline|Total|Total of all reporting groups
10973240|NCT00925938|FG000|Participant Flow|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
10973241|NCT00925938|FG001|Participant Flow|MVPI 800 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB)."
10973242|NCT00925938|FG002|Participant Flow|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
10973243|NCT00925938|OG000|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
10973244|NCT00925938|OG001|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
10973245|NCT00925938|OG002|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
10973246|NCT00925938|EG000|Reported Event|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
10973247|NCT00925938|EG001|Reported Event|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
10973248|NCT00925938|EG002|Reported Event|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
10973249|NCT00925990|BG000|Baseline|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
10973250|NCT00925990|BG001|Baseline|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
10973251|NCT00925990|BG002|Baseline|Total|Total of all reporting groups
10973252|NCT00925990|FG000|Participant Flow|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
10973253|NCT00925990|FG001|Participant Flow|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
10973254|NCT00925990|OG000|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
10973255|NCT00925990|OG001|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
10973256|NCT00925990|EG000|Reported Event|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
10973257|NCT00925990|EG001|Reported Event|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
10973258|NCT00926003|BG000|Baseline|CCRT Intervention|"Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks~Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program"
10973259|NCT00926003|BG001|Baseline|Control|Passive Control with no intervention training for 8 weeks
10973260|NCT00926003|BG002|Baseline|Limited CCRT|"Locked CCRT that does not become more difficult with mastery of child on computer games training~Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training"
10973261|NCT00926003|BG003|Baseline|Total|Total of all reporting groups
10973262|NCT00926003|FG000|Participant Flow|CCRT Intervention|"Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks~Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program"
10973263|NCT00926003|FG001|Participant Flow|Control|Passive Control with no intervention training for 8 weeks
10973264|NCT00926003|FG002|Participant Flow|Limited CCRT|"Locked CCRT that does not become more difficult with mastery of child on computer games training~Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training"
10973265|NCT00926003|OG000|Outcome|CCRT Intervention|"Computer Cognitive Rehabilitation Training Intervention 24 sessions over 8 weeks~Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program"
10973266|NCT00926003|OG001|Outcome|Control|Passive Control with no intervention training for 8 weeks
10973267|NCT00926003|OG002|Outcome|Limited CCRT|"Locked CCRT that does not become more difficult with mastery of child on computer games training~Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training"
10973268|NCT00926003|EG000|Reported Event|CCRT Intervention|"Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week)~Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program"
10973269|NCT00926003|EG001|Reported Event|Control|Passive Control with no intervention training for 8 weeks
10973270|NCT00926003|EG002|Reported Event|Limited CCRT|"Locked CCRT that does not become more difficult with mastery of child on computer games training~Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training"
10973271|NCT00926029|BG000|Baseline|Placebo Control|fluoride toothpaste
10973272|NCT00926029|BG001|Baseline|Positive Control|triclosan/fluoride toothpaste
10973273|NCT00926029|BG002|Baseline|Experimental|triclosan/fluoride/zinc toothpaste
10973274|NCT00926029|BG003|Baseline|Total|Total of all reporting groups
10973275|NCT00926029|FG000|Participant Flow|Placebo Control|fluoride toothpaste (Winterfresh Gel)
10973276|NCT00926029|FG001|Participant Flow|Positive Control|triclosan/fluoride toothpaste
10973277|NCT00926029|FG002|Participant Flow|Experimental|triclosan/fluoride/metal salt toothpaste
10973278|NCT00926029|OG000|Outcome|Placebo Control|fluoride toothpaste (Winterfresh Gel)
10973279|NCT00926029|OG001|Outcome|Positive Control|triclosan/fluoride toothpaste
10973280|NCT00926029|OG002|Outcome|Experimental|triclosan/fluoride/metal salt toothpaste
10973281|NCT00926029|OG000|Outcome|Placebo Control|fluoride toothpaste
10973282|NCT00926029|OG002|Outcome|Experimental|triclosan/fluoride/zinc toothpaste
10973283|NCT00926029|EG000|Reported Event|Placebo Control|fluoride toothpaste (Winterfresh Gel)
10973284|NCT00926029|EG001|Reported Event|Positive Control|triclosan/fluoride toothpaste
10973285|NCT00926029|EG002|Reported Event|Experimental|triclosan/fluoride/metal salt toothpaste
10973286|NCT00926185|BG000|Baseline|Lifitegrast 0.1%|
10973287|NCT00926185|BG001|Baseline|Lifitegrast 1.0%|
10973288|NCT00926185|BG002|Baseline|Lifitegrast 5.0%|
10973289|NCT00926185|BG003|Baseline|Placebo|
10973290|NCT00926185|BG004|Baseline|Total|Total of all reporting groups
10973291|NCT00926185|FG000|Participant Flow|Lifitegrast 0.1%|
10973292|NCT00926185|FG001|Participant Flow|Lifitegrast 1.0%|
10973293|NCT00926185|FG002|Participant Flow|Lifitegrast 5.0%|
10973294|NCT00926185|FG003|Participant Flow|Placebo|
10973295|NCT00926185|OG000|Outcome|Lifitegrast 0.1%|
10973296|NCT00926185|OG001|Outcome|Lifitegrast 1.0%|
10973297|NCT00926185|OG002|Outcome|Lifitegrast 5.0%|
10973298|NCT00926185|OG003|Outcome|Placebo|
10973299|NCT00926185|EG000|Reported Event|Lifitegrast 0.1%|
10973300|NCT00926185|EG001|Reported Event|Lifitegrast 1.0%|
10973301|NCT00926185|EG002|Reported Event|Lifitegrast 5.0%|
10973302|NCT00926185|EG003|Reported Event|Placebo|
10973303|NCT00926211|BG000|Baseline|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
10973304|NCT00926211|FG000|Participant Flow|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
10973305|NCT00926211|OG000|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
10973306|NCT00926211|OG001|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
10973307|NCT00926211|EG000|Reported Event|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
10973308|NCT00926237|BG000|Baseline|All Subjects Enrolled in the Study|Baseline information is reported for all subjects enrolled.
10973309|NCT00926237|FG000|Participant Flow|Sham Followed by Active 1Hz Then 10Hz rTMS|"Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.~Sham rTMS~Active 1 Hz rTMS~Active 1 Hz rTMS"
10973310|NCT00926237|FG001|Participant Flow|Sham Followed by Active 10Hz Then 1Hz rTMS|"Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.~Sham rTMS~Active 1 Hz rTMS~Active 10 Hz rTMS"
10973311|NCT00926237|OG000|Outcome|Sham rTMS|This comparison examined change in analogue ratings of tinnitus awareness between the baseline and the sham rTMS treatment condition.
10973312|NCT00926237|OG001|Outcome|Sham Washout|This comparison examined change in analogue ratings of tinnitus awareness between baseline and the sham washout period of 21 days.
10973313|NCT00926237|OG002|Outcome|1 Hz Active rTMS|This comparison examined change in analogue ratings of tinnitus awareness between the baseline and the 1 Hz active rTMS condition.
10973314|NCT00926237|OG003|Outcome|1 Hz Washout|This comparison examined change in analogue ratings of tinnitus awareness between baseline and the 1 Hz washout period lasting 21 days.
10973315|NCT00926237|OG004|Outcome|10 Hz Active rTMS|This comparison examined change in analogue ratings of tinnitus awareness between the baseline and the 10 Hz active rTMS condition.
10973316|NCT00926237|OG005|Outcome|10 Hz Washout|This comparison examined change in analogue ratings of tinnitus awareness between baseline and the 10 Hz washout period of 21 days.
10973317|NCT00926237|EG000|Reported Event|Subjects Who Received Sham Followed by Active 1 Hz rTMS Then Active 10 Hz rTMS.|Subjects in this arm received a course of sham stimulation which was followed by a course of active stimulation at 1 Hz rTMS and then a course of active stimulation at 10 Hz.
10973318|NCT00926237|EG001|Reported Event|Subjects Who Received Sham Followed by Active 10 Hz rTMS Then Active 1 Hz rTMS|Subjects in this arm received a course of sham stimulation which was followed by a course of active stimulation at 10 Hz rTMS and then a course of active stimulation at 1 Hz.
10973319|NCT00926263|BG000|Baseline|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973320|NCT00926263|BG001|Baseline|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973321|NCT00926263|BG002|Baseline|Total|Total of all reporting groups
10973322|NCT00926263|FG000|Participant Flow|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973323|NCT00926263|FG001|Participant Flow|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973324|NCT00926263|OG000|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973325|NCT00926263|OG001|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973326|NCT00926263|OG000|Outcome|CP-751,871 20/20 mg/kg|Participants not enrolled due to early termination of the study.
10973327|NCT00926263|EG000|Reported Event|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973328|NCT00926263|EG001|Reported Event|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
10973329|NCT00926289|BG000|Baseline|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
10973330|NCT00926289|BG001|Baseline|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
10973331|NCT00926289|BG002|Baseline|Total|Total of all reporting groups
10973332|NCT00926289|FG000|Participant Flow|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
10973333|NCT00926289|FG001|Participant Flow|Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
10973334|NCT00926289|OG000|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
10973335|NCT00926289|OG001|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
10973336|NCT00926289|EG000|Reported Event|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
10973337|NCT00926289|EG001|Reported Event|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
10973338|NCT00926328|BG000|Baseline|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
10973339|NCT00926328|BG001|Baseline|Placebo Control|sodium fluoride toothpaste
10973340|NCT00926328|BG002|Baseline|Total|Total of all reporting groups
10973341|NCT00926328|FG000|Participant Flow|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
10973342|NCT00926328|FG001|Participant Flow|Placebo Control|sodium fluoride toothpaste
10973343|NCT00926328|OG000|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
10973344|NCT00926328|OG001|Outcome|Placebo Control|sodium fluoride toothpaste
10973345|NCT00926328|EG000|Reported Event|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
10973346|NCT00926328|EG001|Reported Event|Placebo Control|sodium fluoride toothpaste
10973347|NCT00926367|BG000|Baseline|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
10973348|NCT00926367|BG001|Baseline|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
10973349|NCT00926367|BG002|Baseline|Total|Total of all reporting groups
10973350|NCT00926367|FG000|Participant Flow|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
10973351|NCT00926367|FG001|Participant Flow|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
10973352|NCT00926367|OG000|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
10973353|NCT00926367|OG001|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
10973354|NCT00926367|OG000|Outcome|Duac|Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
10973355|NCT00926367|OG001|Outcome|Epiduo|Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
10973356|NCT00926367|EG000|Reported Event|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
10973357|NCT00926367|EG001|Reported Event|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
10973358|NCT00926380|BG000|Baseline|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
10973359|NCT00926380|BG001|Baseline|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
10973360|NCT00926380|BG002|Baseline|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
10973361|NCT00926380|BG003|Baseline|Total|Total of all reporting groups
10973362|NCT00926380|FG000|Participant Flow|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
10973363|NCT00926380|FG001|Participant Flow|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
10973364|NCT00926380|FG002|Participant Flow|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
10973365|NCT00926380|OG000|Outcome|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
10973366|NCT00926380|OG001|Outcome|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
10973367|NCT00926380|OG002|Outcome|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
10973368|NCT00926380|EG000|Reported Event|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
10973369|NCT00926380|EG001|Reported Event|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
10973370|NCT00926380|EG002|Reported Event|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
10973371|NCT00926393|BG000|Baseline|Quetiapine IR|Quetiapine fumarate Immediate Release
10973372|NCT00926393|BG001|Baseline|Quetiapine XR|Quetiapine fumarate Extended Release
10973373|NCT00926393|BG002|Baseline|Total|Total of all reporting groups
10973374|NCT00926393|FG000|Participant Flow|Quetiapine IR|Quetiapine fumarate Immediate Release
10973375|NCT00926393|FG001|Participant Flow|Quetiapine XR|Quetiapine fumarate Extended Release
10973376|NCT00926393|OG000|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
10973377|NCT00926393|OG001|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
10973378|NCT00926393|EG000|Reported Event|Quetiapine IR|Quetiapine fumarate Immediate Release
10973379|NCT00926393|EG001|Reported Event|Quetiapine XR|Quetiapine fumarate Extended Release
10973380|NCT00926497|BG000|Baseline|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
10973381|NCT00926497|BG001|Baseline|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
10973382|NCT00926497|BG002|Baseline|Total|Total of all reporting groups
10973383|NCT00926497|FG000|Participant Flow|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
10973384|NCT00926497|FG001|Participant Flow|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
10973385|NCT00926497|OG000|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
10973386|NCT00926497|OG001|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
10973387|NCT00926497|EG000|Reported Event|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
10973388|NCT00926497|EG001|Reported Event|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
10973389|NCT00926536|BG000|Baseline|C-arm CT + DSA as Needed|C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking
10973390|NCT00926536|BG001|Baseline|DSA Only|DSA images only used for vessel navigation and tracking
10973391|NCT00926536|BG002|Baseline|Total|Total of all reporting groups
10973392|NCT00926536|FG000|Participant Flow|C-arm CT +DSA as Needed|C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation
10973393|NCT00926536|FG001|Participant Flow|DSA Only|Only Digital subtraction images used for vessel tracking and tumor navigation
10973394|NCT00926536|OG000|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
10973395|NCT00926536|OG001|Outcome|DSA Only|Only DSA imaging used for navigational purposes
10973396|NCT00926536|EG000|Reported Event|C-arm CT + DSA as Needed|C-arm CT used for the purposes of navigation, supplemented by DSA if needed
10973397|NCT00926536|EG001|Reported Event|DSA Only|DSA only used for navigation
10973398|NCT00926588|BG000|Baseline|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
10973399|NCT00926588|BG001|Baseline|Usual Care|Patients receive usual care for pain from their primary care physician
10973400|NCT00926588|BG002|Baseline|Total|Total of all reporting groups
10973401|NCT00926588|FG000|Participant Flow|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
10973402|NCT00926588|FG001|Participant Flow|Usual Care|Patients receive usual care for pain from their primary care physician
10973403|NCT00926588|OG000|Outcome|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
10973404|NCT00926588|OG001|Outcome|Usual Care|Patients receive usual care for pain from their primary care physician
10973405|NCT00926588|EG000|Reported Event|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
10973406|NCT00926588|EG001|Reported Event|Usual Care|Patients receive usual care for pain from their primary care physician
10973407|NCT00926783|BG000|Baseline|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
10973408|NCT00926783|BG001|Baseline|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
10973409|NCT00926783|BG002|Baseline|Total|Total of all reporting groups
10973410|NCT00926783|FG000|Participant Flow|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
10973411|NCT00926783|FG001|Participant Flow|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
10973412|NCT00926783|OG000|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
10973413|NCT00926783|OG001|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
10973414|NCT00926783|EG000|Reported Event|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
10973415|NCT00926783|EG001|Reported Event|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
10973416|NCT00926796|BG000|Baseline|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
10973417|NCT00926796|BG001|Baseline|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
10973418|NCT00926796|BG002|Baseline|Total|Total of all reporting groups
10973419|NCT00926796|FG000|Participant Flow|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
10973420|NCT00926796|FG001|Participant Flow|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
10973421|NCT00926796|OG000|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
10973422|NCT00926796|OG001|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
10973423|NCT00926796|OG000|Outcome|Baseline|All per protocol participants at baseline with evaluable isolates
10973424|NCT00926796|OG000|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
10973425|NCT00926796|EG000|Reported Event|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
10973426|NCT00926796|EG001|Reported Event|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
10973427|NCT00926848|BG000|Baseline|PaTH Intervention Group|Patients and partners participated in 18-36 exercise and 18 educational sessions.
10973428|NCT00926848|BG001|Baseline|Usual Care Group|Only patients participated in 18-36 exercise and 18 educational sessions. Partners only participated in educational sessions.
10973429|NCT00926848|BG002|Baseline|Total|Total of all reporting groups
10973430|NCT00926848|FG000|Participant Flow|Usual Care Group|In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
10973431|NCT00926848|FG001|Participant Flow|PaTH Intervention Group|Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks. These CR components were: prescribed exercise, education about cardiac risk factor modification, and counseling about self-efficacy strategies that may be effective in assisting with initial lifestyle changes and in preventing and managing relapse. All patients and partners in CR will be provided with a comprehensive, individualized, multidisciplinary risk factor modification program focused on all of the person's risk factors for coronary heart disease.
10973432|NCT00926848|OG000|Outcome|PaTH Intervention Group (Patients Only, n=17)|Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
10973433|NCT00926848|OG001|Outcome|Usual Care Group (Patients Only, n=17)|In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
10973434|NCT00926848|OG000|Outcome|PaTH Intervention Group (Partners Only, n=17)|Partners in the PaTH intervention group participated in 18-36 exercise sessions and 18 educational sessions.
10973435|NCT00926848|OG001|Outcome|Usual Care Group (Partners Only, n=17)|In the usual care group, partners participated in 18 educational sessions.
10973436|NCT00926848|OG000|Outcome|PaTH Intervention Group (Patients Only)|Patients in the PaTH intervention group participated in 18-36 exercise sessions and 18 educational sessions.
10973437|NCT00926848|OG001|Outcome|Usual Care Group (Patients Only)|The usual care group intervention for patients only consisted of participation in 18-36 exercise sessions and 18 educational sessions. Partners participated in the 18 educational sessions only.
10973438|NCT00926848|OG000|Outcome|PaTH Intervention Group (Partners Only)|Partners in the PaTH intervention group participated in 18-36 exercise sessions and 18 educational sessions.
10973439|NCT00926848|OG001|Outcome|Usual Care Group (Partners Only)|Partners in the usual care group participated in the 18 educational sessions only.
10973440|NCT00926848|OG000|Outcome|PaTH Intervention Group (Patients Only)|"The PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program:~18-36 exercise sessions~18 educational sessions"
10973441|NCT00926848|OG001|Outcome|Usual Care Group (Patients Only)|"The usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program:~18-36 exercise sessions and 18 educational sessions~Partners participated in the 18 educational sessions only."
10973442|NCT00926848|OG000|Outcome|PaTH Intervention Group (Partners)|"The PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program:~18-36 exercise sessions~18 educational sessions"
10973443|NCT00926848|OG001|Outcome|Usual Care Group (Partners)|"The usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program:~18-36 exercise sessions and 18 educational sessions~Partners participated in the 18 educational sessions only."
10973444|NCT00926848|EG000|Reported Event|PaTH Intervention Group|Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
10973445|NCT00926848|EG001|Reported Event|Usual Care Group|In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
10973446|NCT00926887|BG000|Baseline|Placebo Laser|inactive light
10973447|NCT00926887|BG001|Baseline|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
10973448|NCT00926887|BG002|Baseline|Total|Total of all reporting groups
10973449|NCT00926887|FG000|Participant Flow|Placebo Laser|inactive light
10973450|NCT00926887|FG001|Participant Flow|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
10973451|NCT00926887|OG000|Outcome|Placebo Laser|inactive light
10973452|NCT00926887|OG001|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
10973453|NCT00926887|EG000|Reported Event|Placebo Laser|inactive light
10973454|NCT00926887|EG001|Reported Event|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
10973455|NCT00926952|BG000|Baseline|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
10973456|NCT00926952|FG000|Participant Flow|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
10973457|NCT00926952|OG000|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
10973458|NCT00926952|EG000|Reported Event|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
10973459|NCT00927069|BG000|Baseline|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
10973460|NCT00927069|BG001|Baseline|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
10973461|NCT00927069|BG002|Baseline|Total|Total of all reporting groups
10973462|NCT00927069|FG000|Participant Flow|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
10973463|NCT00927069|FG001|Participant Flow|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
10973464|NCT00927069|FG002|Participant Flow|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
10973465|NCT00927069|FG003|Participant Flow|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
10973466|NCT00927069|OG000|Outcome|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
10973467|NCT00927069|OG000|Outcome|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
10973468|NCT00927069|OG000|Outcome|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
10973469|NCT00927069|OG000|Outcome|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
10973470|NCT00927069|OG000|Outcome|Group A|Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
10973471|NCT00927069|OG001|Outcome|Group B|Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
10973472|NCT00927069|EG000|Reported Event|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
10973473|NCT00927069|EG001|Reported Event|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
10973474|NCT00927082|BG000|Baseline|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973475|NCT00927082|BG001|Baseline|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973476|NCT00927082|BG002|Baseline|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973477|NCT00927082|BG003|Baseline|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973478|NCT00927082|BG004|Baseline|Total|Total of all reporting groups
10973479|NCT00927082|FG000|Participant Flow|PEG-IFN 90mcg 24 Wks|Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
10973480|NCT00927082|FG001|Participant Flow|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973481|NCT00927082|FG002|Participant Flow|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973482|NCT00927082|FG003|Participant Flow|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973483|NCT00927082|OG000|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973484|NCT00927082|OG001|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973485|NCT00927082|OG002|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973486|NCT00927082|OG003|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973487|NCT00927082|OG000|Outcome|Group A|Participants received 90 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973488|NCT00927082|OG001|Outcome|Group B|Participants received 180 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973489|NCT00927082|OG002|Outcome|Group C|Participants received 90 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973490|NCT00927082|OG003|Outcome|Group D|Participants received 180 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973491|NCT00927082|EG000|Reported Event|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973492|NCT00927082|EG001|Reported Event|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
10973493|NCT00927082|EG002|Reported Event|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973494|NCT00927082|EG003|Reported Event|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
10973495|NCT00927095|BG000|Baseline|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
10973496|NCT00927095|BG001|Baseline|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
10973497|NCT00927095|BG002|Baseline|Continuous Placebo|"continuous placebo~placebo: daily"
10973498|NCT00927095|BG003|Baseline|Total|Total of all reporting groups
10973499|NCT00927095|FG000|Participant Flow|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
10973500|NCT00927095|FG001|Participant Flow|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
10973501|NCT00927095|FG002|Participant Flow|Continuous Placebo|"continuous placebo~placebo: daily"
10973502|NCT00927095|OG000|Outcome|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
10973503|NCT00927095|OG001|Outcome|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
10973504|NCT00927095|OG002|Outcome|Continuous Placebo|"continuous placebo~placebo: daily"
10973505|NCT00927095|EG000|Reported Event|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
10973506|NCT00927095|EG001|Reported Event|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
10973507|NCT00927095|EG002|Reported Event|Continuous Placebo|"continuous placebo~placebo: daily"
10973508|NCT00927160|BG000|Baseline|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
10973509|NCT00927160|BG001|Baseline|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
10973510|NCT00927160|BG002|Baseline|Total|Total of all reporting groups
10973511|NCT00927160|FG000|Participant Flow|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
10973512|NCT00927160|FG001|Participant Flow|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
10973513|NCT00927160|OG000|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
10973514|NCT00927160|OG001|Outcome|Usual Care|Matching group of patients admitted to general medical service
10973515|NCT00927160|EG000|Reported Event|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
10973516|NCT00927160|EG001|Reported Event|Usual Care|Matching group of patients admitted to general medical service
10973517|NCT00927186|BG000|Baseline|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973518|NCT00927186|BG001|Baseline|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973519|NCT00927186|BG002|Baseline|Total|Total of all reporting groups
10825749|NCT00098748|OG000|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
10825750|NCT00098748|OG001|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
10825751|NCT00098748|OG002|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
10825752|NCT00098748|EG000|Reported Event|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
10825753|NCT00098748|EG001|Reported Event|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
10825754|NCT00098748|EG002|Reported Event|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
10825755|NCT00098774|BG000|Baseline|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
10825756|NCT00098774|FG000|Participant Flow|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
10825757|NCT00098774|OG000|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
10825758|NCT00098774|EG000|Reported Event|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
10825759|NCT00098787|BG000|Baseline|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825760|NCT00098787|BG001|Baseline|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825761|NCT00098787|BG002|Baseline|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
10825762|NCT00098787|BG003|Baseline|Total|Total of all reporting groups
10825763|NCT00098787|FG000|Participant Flow|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825764|NCT00098787|FG001|Participant Flow|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825765|NCT00098787|FG002|Participant Flow|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
10825766|NCT00098787|OG000|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825767|NCT00098787|OG001|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825768|NCT00098787|OG002|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
10825769|NCT00098787|EG000|Reported Event|High TS: IROX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
10825770|NCT00098787|EG001|Reported Event|High TS: FOLFOX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
10825771|NCT00098787|EG002|Reported Event|Low or Indeterminate TS: FOLFOX/Bev|Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
10825772|NCT00098813|BG000|Baseline|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
10825773|NCT00098813|FG000|Participant Flow|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
10825774|NCT00098813|OG000|Outcome|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
10825775|NCT00098813|EG000|Reported Event|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
10825776|NCT00098839|BG000|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825777|NCT00098839|BG001|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825778|NCT00098839|BG002|Baseline|Total|Total of all reporting groups
10825779|NCT00098839|FG000|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825780|NCT00098839|FG001|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10842631|NCT00248625|OG001|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
10825781|NCT00098839|OG000|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825782|NCT00098839|OG001|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825783|NCT00098839|OG000|Outcome|Twice Weekly Dosing Schedule|Epratuzumab 360 mg/m2 x 8 doses - Part B (Amendment 5)
10825784|NCT00098839|EG000|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825785|NCT00098839|EG001|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
10825786|NCT00098865|BG000|Baseline|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
10825787|NCT00098865|FG000|Participant Flow|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression"
10825788|NCT00098865|OG000|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
10825789|NCT00098865|EG000|Reported Event|Thalidomide and Temzolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
10825790|NCT00098956|BG000|Baseline|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
10973520|NCT00927186|FG000|Participant Flow|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
10973521|NCT00927186|FG001|Participant Flow|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
10973522|NCT00927186|OG000|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973523|NCT00927186|OG001|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973524|NCT00927186|OG000|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
10973525|NCT00927186|OG001|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
10973526|NCT00927186|OG001|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension"
10973527|NCT00927186|EG000|Reported Event|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973528|NCT00927186|EG001|Reported Event|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
10973529|NCT00927251|BG000|Baseline|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
10973530|NCT00927251|FG000|Participant Flow|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
10973531|NCT00927251|OG000|Outcome|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
10973532|NCT00927251|EG000|Reported Event|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
10973533|NCT00927264|BG000|Baseline|Behavioral|"Motivational Interviewing Intervention Plus Education~Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
10973534|NCT00927264|BG001|Baseline|Education Only|"Caregivers will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
10973535|NCT00927264|BG002|Baseline|Total|Total of all reporting groups
11092678|NCT01541371|OG000|Outcome|Lack of Efficacy Group|Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
10825791|NCT00098956|FG000|Participant Flow|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
10825792|NCT00098956|OG000|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
10825793|NCT00098956|EG000|Reported Event|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
10825794|NCT00099021|BG000|Baseline|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
10825795|NCT00099021|FG000|Participant Flow|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
10825796|NCT00099021|OG000|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
10825797|NCT00099021|EG000|Reported Event|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
10825798|NCT00099047|BG000|Baseline|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825799|NCT00099047|BG001|Baseline|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825800|NCT00099047|BG002|Baseline|Total|Total of all reporting groups
10825801|NCT00099047|FG000|Participant Flow|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825802|NCT00099047|FG001|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825803|NCT00099047|OG000|Outcome|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825804|NCT00099047|OG001|Outcome|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825805|NCT00099047|EG000|Reported Event|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825806|NCT00099047|EG001|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
10825807|NCT00099268|BG000|Baseline|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825808|NCT00099268|BG001|Baseline|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825809|NCT00099268|BG002|Baseline|Total|Total of all reporting groups
10825810|NCT00099268|FG000|Participant Flow|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825811|NCT00099268|FG001|Participant Flow|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825812|NCT00099268|OG000|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825813|NCT00099268|OG001|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825814|NCT00099268|EG000|Reported Event|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825815|NCT00099268|EG001|Reported Event|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
10825816|NCT00099359|BG000|Baseline|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
10825817|NCT00099359|BG001|Baseline|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
10973536|NCT00927264|FG000|Participant Flow|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
10973537|NCT00927264|FG001|Participant Flow|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
10973538|NCT00927264|OG000|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
10973539|NCT00927264|OG001|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
10973540|NCT00927264|OG000|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
10973541|NCT00927264|OG001|Outcome|Education Only|"Caregivers will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
10973542|NCT00927264|EG000|Reported Event|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
10973543|NCT00927264|EG001|Reported Event|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
10973544|NCT00927355|BG000|Baseline|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
10973545|NCT00927355|BG001|Baseline|Placebo|The other half will be randomized to placebo.
10973546|NCT00927355|BG002|Baseline|Total|Total of all reporting groups
10973547|NCT00927355|FG000|Participant Flow|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
10973548|NCT00927355|FG001|Participant Flow|Placebo|The other half will be randomized to placebo, starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
10973549|NCT00927355|OG000|Outcome|Pioglitazone-Osteoblast CFU (Colony Forming Units)|Percent change in Osteoblast CFU numbers as stained with Alizarin red S at baseline and 6 months after treatment with study drug.
10973550|NCT00927355|OG001|Outcome|Placebo-OSteoblast CFU|Percent change in Osteoblast CFU numbers as stained with Alizarin at baseline and 6 months after treatment with study drug.
10973551|NCT00927355|OG002|Outcome|Pioglitazone-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O at baseline and 6 months after treatment with study drug.
10973552|NCT00927355|OG003|Outcome|Placebo-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O, at baseline and 6 months after treatment with study drug.
10973553|NCT00927355|OG000|Outcome|Pioglitazone-Adiponectin|serum adiponectin percent change 6 mo after study drug Rx compared to baseline.
10973554|NCT00927355|OG001|Outcome|Placebo-Adiponectin|serum adiponectin percent change 6 mo after placebo Rx compared to baseline.
10973555|NCT00927355|OG002|Outcome|Pioglitazone-CTX|serum CTX percent change 6 mo after pioglitazone Rx compared to baseline.
10973556|NCT00927355|OG003|Outcome|Placebo-CTX|serum CTX percent change 6 mo after placebo Rx compared to baseline.
10973557|NCT00927355|OG004|Outcome|Pioglitazone-OSc|serum Osteocalcin percent change 6 mo after pioglitazone Rx compared to baseline.
10973558|NCT00927355|OG005|Outcome|Placebo - Osc|serum Osteocalcin percent change 6 mo after placebo Rx compared to baseline.
10973559|NCT00927355|OG000|Outcome|Pioglitazone-Femoral Neck BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
10973560|NCT00927355|OG001|Outcome|Placebo-Femoral Neck BMD|The other half will be randomized to placebo.
10973561|NCT00927355|OG002|Outcome|Pioglitazone -Lumbar Spine BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
10973562|NCT00927355|OG003|Outcome|Placebo - Lumbar Spine BMD|The other half will be randomized to placebo.
10973563|NCT00927355|EG000|Reported Event|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
10973564|NCT00927355|EG001|Reported Event|Placebo|The other half will be randomized to placebo.
10973565|NCT00927368|BG000|Baseline|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
10973566|NCT00927368|BG001|Baseline|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
10973567|NCT00927368|BG002|Baseline|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
10973568|NCT00927368|BG003|Baseline|Total|Total of all reporting groups
10973569|NCT00927368|FG000|Participant Flow|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
10973570|NCT00927368|FG001|Participant Flow|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
10973571|NCT00927368|FG002|Participant Flow|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
10973572|NCT00927368|OG000|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
10973573|NCT00927368|OG001|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
10825818|NCT00099359|BG002|Baseline|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
10825819|NCT00099359|BG003|Baseline|Total|Total of all reporting groups
10825820|NCT00099359|FG000|Participant Flow|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
10825821|NCT00099359|FG001|Participant Flow|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
10825822|NCT00099359|FG002|Participant Flow|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
10825823|NCT00099359|OG000|Outcome|ARM A (ZDV - Standard of Care)|"ZDV (standard of care), given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
10825824|NCT00099359|OG001|Outcome|ARM B (ZDV + NVP)|plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
10825825|NCT00099359|OG002|Outcome|ARM C (ZDV +3TC+NFV)|"ZDV (standard of care) plus 3TC, given for 2 weeks:~6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
10825826|NCT00099359|OG000|Outcome|ARM A (ZDV Only)|ZDV only
10825827|NCT00099359|OG001|Outcome|ARM B (ZDV + NVP)|ZDV + NVP
10825828|NCT00099359|OG002|Outcome|ARM C (ZDV + 3TC/NFV)|ZDV + 3TC/NFV
10825829|NCT00099359|OG000|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
10825830|NCT00099359|OG001|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
10825831|NCT00099359|OG002|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
10825832|NCT00099359|OG000|Outcome|ARM C (ZDV + 3TC/NFV)|Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.
10825833|NCT00099359|OG000|Outcome|Infected|Infants infected after birth
10825834|NCT00099359|OG001|Outcome|Uninfected|Infants uninfected after birth
10825835|NCT00099359|OG000|Outcome|ARM B (ZDV + NVP)|NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.
10825836|NCT00099359|EG000|Reported Event|ARM A (ZDV Alone)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
10825837|NCT00099359|EG001|Reported Event|ARM B (ZDV + NVP)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams~AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
10825838|NCT00099359|EG002|Reported Event|ARM C (ZDV + 3TC/NFV)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
10842632|NCT00248625|EG000|Reported Event|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
10842633|NCT00248625|EG001|Reported Event|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization."
10842634|NCT00248638|BG000|Baseline|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
10842635|NCT00248638|BG001|Baseline|Standard|Participants given standard nutrition without glutamine dipeptide
10842636|NCT00248638|BG002|Baseline|Total|Total of all reporting groups
10842637|NCT00248638|FG000|Participant Flow|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
10842638|NCT00248638|FG001|Participant Flow|Standard|Participants given standard nutrition without glutamine dipeptide
10842639|NCT00248638|OG000|Outcome|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
10842640|NCT00248638|OG001|Outcome|Standard|Participants given standard nutrition without glutamine dipeptide
10973574|NCT00927368|OG002|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
10973575|NCT00927368|EG000|Reported Event|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
10973576|NCT00927368|EG001|Reported Event|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
10973577|NCT00927368|EG002|Reported Event|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
10973578|NCT00927394|BG000|Baseline|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
10973579|NCT00927394|BG001|Baseline|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
10973580|NCT00927394|BG002|Baseline|Total|Total of all reporting groups
10973581|NCT00927394|FG000|Participant Flow|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
10973582|NCT00927394|FG001|Participant Flow|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
10973583|NCT00927394|OG000|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
10973584|NCT00927394|OG001|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
10973585|NCT00927394|OG000|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
10973586|NCT00927394|EG000|Reported Event|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
10973587|NCT00927394|EG001|Reported Event|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
10973588|NCT00927472|BG000|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10973589|NCT00927472|BG001|Baseline|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
10973590|NCT00927472|BG002|Baseline|Total|Total of all reporting groups
10973591|NCT00927472|FG000|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10973592|NCT00927472|FG001|Participant Flow|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
10973593|NCT00927472|OG000|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10973594|NCT00927472|OG001|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
10973595|NCT00927472|EG000|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
10973596|NCT00927472|EG001|Reported Event|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
10973597|NCT00927485|BG000|Baseline|Curcumin|"Curcumin~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973598|NCT00927485|BG001|Baseline|Placebo|"Placebo (sugar pills)~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973599|NCT00927485|BG002|Baseline|Total|Total of all reporting groups
10973600|NCT00927485|FG000|Participant Flow|Curcumin|"Curcumin~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973601|NCT00927485|FG001|Participant Flow|Placebo|"Placebo (sugar pills)~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973602|NCT00927485|OG000|Outcome|Curcumin|"Curcumin~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973603|NCT00927485|OG001|Outcome|Placebo|"Placebo (sugar pills)~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973604|NCT00927485|EG000|Reported Event|Curcumin|"Curcumin~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973605|NCT00927485|EG001|Reported Event|Placebo|"Placebo (sugar pills)~Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).~Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.~Blood samples: Three tubes of blood at visits 0, 4 and 12 months.~Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.~Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy."
10973606|NCT00927563|BG000|Baseline|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
10973607|NCT00927563|FG000|Participant Flow|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
10973608|NCT00927563|OG000|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
10973609|NCT00927563|EG000|Reported Event|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
10973610|NCT00927576|BG000|Baseline|Control Subjects|Control subjects = 230. Normal control subjects of various ages.
10973611|NCT00927576|BG001|Baseline|TBI Patients|TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
10973612|NCT00927576|BG002|Baseline|Total|Total of all reporting groups
10973613|NCT00927576|FG000|Participant Flow|Control Subjects|Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
10973614|NCT00927576|FG001|Participant Flow|TBI Patients|TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
10973615|NCT00927576|OG000|Outcome|Simple Reaction Time Test|time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
10973616|NCT00927576|EG000|Reported Event|Control Subjects|Control subjects = 237. No adverse events were observed.
10973617|NCT00927576|EG001|Reported Event|TBI Patients|TBI patients N = 28. No adverse events were observed
10973618|NCT00927589|BG000|Baseline|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
10973619|NCT00927589|FG000|Participant Flow|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 milligrams per kilogram (mg/kg) of body weight given by intravenous (IV) infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 milligrams per square meter (mg/m^2) of body surface area (BSA) on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target area under the concentration-versus-time curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
10973620|NCT00927589|OG000|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
10973621|NCT00927589|EG000|Reported Event|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
10973622|NCT00927758|BG000|Baseline|All Randomized Patients|Baseline measured for all randomized (safety set) patients.
11092679|NCT01541371|OG001|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
10973623|NCT00927758|FG000|Participant Flow|Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973624|NCT00927758|FG001|Participant Flow|Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973625|NCT00927758|FG002|Participant Flow|Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973626|NCT00927758|FG003|Participant Flow|Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973627|NCT00927758|FG004|Participant Flow|Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973628|NCT00927758|FG005|Participant Flow|Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
10973629|NCT00927758|OG000|Outcome|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
10973630|NCT00927758|OG001|Outcome|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
10973631|NCT00927758|OG002|Outcome|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
10973632|NCT00927758|EG000|Reported Event|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
10973633|NCT00927758|EG001|Reported Event|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
10973634|NCT00927758|EG002|Reported Event|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
10973635|NCT00927784|BG000|Baseline|Low Dose Cohort: Treatment Group|Intramyocardial injection of study drug (25 million MPC) (Revasacor TM)at the time of LVAD implantation
10973636|NCT00927784|BG001|Baseline|Low Dose Cohort: Control Group|Intramyocardial injection of vehicle (50% alpha-MEM/42.5% proFreeze NAO Freezing Medium/7.5%DMSO) at the time of LVAD implantation.
10973637|NCT00927784|BG002|Baseline|Total|Total of all reporting groups
10973638|NCT00927784|FG000|Participant Flow|Low Dose Cohort: Treatment Group|Intramyocardial injection of study drug (25 million MPC) (Revasacor TM)at the time of LVAD implantation
10973639|NCT00927784|FG001|Participant Flow|Low Dose Cohort: Control Group|Intramyocardial injection of vehicle (50% alpha-MEM/42.5% proFreeze NAO Freezing Medium/7.5%DMSO) at the time of LVAD implantation.
10973640|NCT00927784|OG000|Outcome|Low Dose Cohort: Treatment Group|Intramyocardial injection of study drug (25 million MPC) (Revasacor TM)at the time of LVAD implantation
10973641|NCT00927784|OG001|Outcome|Low Dose Cohort: Control Group|Intramyocardial injection of vehicle (50% alpha-MEM/42.5% proFreeze NAO Freezing Medium/7.5%DMSO) at the time of LVAD implantation.
10973642|NCT00927784|EG000|Reported Event|Low Dose Cohort: Treatment Group|Intramyocardial injection of study drug (25 million MPC) (Revasacor TM)at the time of LVAD implantation
10973643|NCT00927784|EG001|Reported Event|Low Dose Cohort: Control Group|Intramyocardial injection of vehicle (50% alpha-MEM/42.5% proFreeze NAO Freezing Medium/7.5%DMSO) at the time of LVAD implantation.
10973644|NCT00927810|BG000|Baseline|Core: Canakinumab, Extension: 150 mg Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973645|NCT00927810|BG001|Baseline|Core: Canakinumab, Extension: No Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973646|NCT00927810|BG002|Baseline|Core: Colchicine, Extension: 150 mg Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973647|NCT00927810|BG003|Baseline|Core: Colchicine, Extension: No Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973648|NCT00927810|BG004|Baseline|Total|Total of all reporting groups
10973649|NCT00927810|FG000|Participant Flow|Core: Canakinumab, Extension: 150 mg Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973650|NCT00927810|FG001|Participant Flow|Core: Canakinumab, Extension: No Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973651|NCT00927810|FG002|Participant Flow|Core: Colchicine, Extension: 150 mg Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single SC dose of 150 mg Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973652|NCT00927810|FG003|Participant Flow|Core: Colchicine, Extension: No Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not receive canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973653|NCT00927810|OG000|Outcome|Core: Canakinumab, Extension: 150 mg Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973654|NCT00927810|OG001|Outcome|Core: Canakinumab, Extension: No Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973655|NCT00927810|OG002|Outcome|Core: Colchicine, Extension: 150 mg Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973656|NCT00927810|OG003|Outcome|Core: Colchicine, Extension: No Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973657|NCT00927810|OG001|Outcome|Core: Colchicine, Extension: 150 mg Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973658|NCT00927810|EG000|Reported Event|Core: Canakinumab 25 mg|Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10973659|NCT00927810|EG001|Reported Event|Core: Canakinumab 50 mg|Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10973660|NCT00927810|EG002|Reported Event|Core: Canakinumab 100 mg|Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10973661|NCT00927810|EG003|Reported Event|Core: Canakinumab 200 mg|Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10973662|NCT00927810|EG004|Reported Event|Core: Canakinumab 300 mg|Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
10973663|NCT00927810|EG005|Reported Event|Core : Canakinumab Q4wk mg|Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
10973664|NCT00927810|EG006|Reported Event|Core : Colchicine 0.5 mg|Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
10973665|NCT00927810|EG007|Reported Event|Core: Canakinumab, Extension: 150 mg Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973666|NCT00927810|EG008|Reported Event|Core: Canakinumab, Extension: No Canakinumab|Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973667|NCT00927810|EG009|Reported Event|Core: Colchicine, Extension: 150 mg Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
10973668|NCT00927810|EG010|Reported Event|Core: Colchicine, Extension: No Canakinumab|Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
10973669|NCT00927823|BG000|Baseline|Entire Study Population|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973670|NCT00927823|FG000|Participant Flow|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973671|NCT00927823|FG001|Participant Flow|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973672|NCT00927823|FG002|Participant Flow|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973673|NCT00927823|FG003|Participant Flow|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973674|NCT00927823|OG000|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973675|NCT00927823|OG001|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973676|NCT00927823|OG002|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973677|NCT00927823|OG003|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973678|NCT00927823|OG000|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973679|NCT00927823|OG000|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
10973680|NCT00927823|OG001|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
10973681|NCT00927823|OG002|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
10973682|NCT00927823|OG003|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
10973683|NCT00927823|OG000|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973684|NCT00927823|OG001|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973685|NCT00927823|EG000|Reported Event|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973686|NCT00927823|EG001|Reported Event|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973687|NCT00927823|EG002|Reported Event|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973688|NCT00927823|EG003|Reported Event|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
10973689|NCT00927849|BG000|Baseline|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
10973690|NCT00927849|BG001|Baseline|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
10973691|NCT00927849|BG002|Baseline|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
10973692|NCT00927849|BG003|Baseline|Total|Total of all reporting groups
10973693|NCT00927849|FG000|Participant Flow|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
10973694|NCT00927849|FG001|Participant Flow|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
10973695|NCT00927849|FG002|Participant Flow|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
10973696|NCT00927849|OG000|Outcome|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
10973697|NCT00927849|OG001|Outcome|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
10973698|NCT00927849|OG002|Outcome|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
10973699|NCT00927849|EG000|Reported Event|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
10973700|NCT00927849|EG001|Reported Event|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
10973701|NCT00927849|EG002|Reported Event|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
10973702|NCT00927862|BG000|Baseline|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
10973703|NCT00927862|BG001|Baseline|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
10973704|NCT00927862|BG002|Baseline|Total|Total of all reporting groups
10973705|NCT00927862|FG000|Participant Flow|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms were randomized to receive either standard or modified International Warfarin Pharmacogenetics Consortium [IWPC] warfarin dosing. The IWPC derived and published a common algorithm to predict stable maintenance dose based on ~5000 patients across broad geographic and ethnic/racial groups (N Engl J Med 2009;360:753-764). Hence, we based our standard algorithm on the IWPC algorithm with minor modifications to accommodate different INR targets and smoking status, based on supplemental data from Gage et al (Clini Pharmacol Ther 2008;84:326 -331). The modified IWPC algorithm included 2 further modifications: (1) It ignored the CYP2C9 variant status for the first 2 days; and (2) It used a special dose-revision algorithm based on a day 4 (or day 5) INR after 3 (or 4) warfarin doses.
10973706|NCT00927862|FG001|Participant Flow|Parellel/Historical Controls|A parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified.
10973707|NCT00927862|OG000|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
10973708|NCT00927862|OG001|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
10973709|NCT00927862|OG000|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
10973710|NCT00927862|OG001|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
10973711|NCT00927862|EG000|Reported Event|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
10973712|NCT00927862|EG001|Reported Event|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
10973713|NCT00927888|BG000|Baseline|Group 1 Bupivacaine|Active treatment group with application of bupivacaine block before FESS.
10973714|NCT00927888|BG001|Baseline|Group 2 - Saline Placebo Group|Saline substituted in block, placebo treatment group with application of saline block before FESS.
10973715|NCT00927888|BG002|Baseline|Total|Total of all reporting groups
10973716|NCT00927888|FG000|Participant Flow|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
10973717|NCT00927888|FG001|Participant Flow|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
10973718|NCT00927888|OG000|Outcome|1 - Bupivacaine Block|"3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)~Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure."
10973719|NCT00927888|OG001|Outcome|2 - Placebo|Normal saline with Epi 1:100,000 (B block)
10973720|NCT00927888|OG000|Outcome|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
10973721|NCT00927888|OG001|Outcome|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
10973722|NCT00927888|EG000|Reported Event|Group 1 - Bupicaine Block|Active treatment group with application of bupivacaine block before FESS.
11312936|NCT03192475|FG001|Participant Flow|GLB Plus Newsletter Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.~GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only."
10973723|NCT00927888|EG001|Reported Event|Group 2 - Saline Placebo Block|Placebo treatment group with application of saline block before FESS.
10973724|NCT00927901|BG000|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973725|NCT00927901|FG000|Participant Flow|Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate|In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973726|NCT00927901|FG001|Participant Flow|Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo|In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973727|NCT00927901|FG002|Participant Flow|Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate|In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973728|NCT00927901|FG003|Participant Flow|Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate|In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973729|NCT00927901|OG000|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973730|NCT00927901|OG001|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10825839|NCT00099372|BG000|Baseline|BURCH URETHROPEXY|Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse
10973731|NCT00927901|OG002|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973732|NCT00927901|OG003|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
11092680|NCT01541371|OG002|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
10973733|NCT00927901|OG001|Outcome|Indacaterol Acetate 400 μg|3Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973734|NCT00927901|OG000|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973735|NCT00927901|OG001|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973736|NCT00927901|EG000|Reported Event|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973737|NCT00927901|EG001|Reported Event|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973738|NCT00927901|EG002|Reported Event|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973739|NCT00927901|EG003|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10973740|NCT00927927|BG000|Baseline|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
10973741|NCT00927927|BG001|Baseline|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
10973742|NCT00927927|BG002|Baseline|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
10973743|NCT00927927|BG003|Baseline|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
10973744|NCT00927927|BG004|Baseline|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
10973745|NCT00927927|BG005|Baseline|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
10973746|NCT00927927|BG006|Baseline|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
10973747|NCT00927927|BG007|Baseline|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
10973748|NCT00927927|BG008|Baseline|SD Placebo|Subjects were dosed once with placebo
10973749|NCT00927927|BG009|Baseline|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
10973750|NCT00927927|BG010|Baseline|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
10973751|NCT00927927|BG011|Baseline|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
10973752|NCT00927927|BG012|Baseline|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
10973753|NCT00927927|BG013|Baseline|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
10973754|NCT00927927|BG014|Baseline|MD Placebo|Subjects were injected biweekly four times with placebo
10973755|NCT00927927|BG015|Baseline|Total|Total of all reporting groups
10973756|NCT00927927|FG000|Participant Flow|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
10973757|NCT00927927|FG001|Participant Flow|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
10973758|NCT00927927|FG002|Participant Flow|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
10973759|NCT00927927|FG003|Participant Flow|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
10973760|NCT00927927|FG004|Participant Flow|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
10973761|NCT00927927|FG005|Participant Flow|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
10973762|NCT00927927|FG006|Participant Flow|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
10973763|NCT00927927|FG007|Participant Flow|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
10973764|NCT00927927|FG008|Participant Flow|SD Placebo|Subjects were dosed once with placebo
10973765|NCT00927927|FG009|Participant Flow|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
10973766|NCT00927927|FG010|Participant Flow|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
10973767|NCT00927927|FG011|Participant Flow|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
10973768|NCT00927927|FG012|Participant Flow|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
10973769|NCT00927927|FG013|Participant Flow|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
10973770|NCT00927927|FG014|Participant Flow|MD Placebo|Subjects were injected biweekly four times with placebo
10973771|NCT00927927|OG000|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
10973772|NCT00927927|OG001|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
10973773|NCT00927927|OG002|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
10973774|NCT00927927|OG003|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
10973775|NCT00927927|OG004|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
10973776|NCT00927927|OG005|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
10973777|NCT00927927|OG006|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
10973778|NCT00927927|OG007|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
10973779|NCT00927927|OG008|Outcome|SD Placebo|Subjects were dosed once with placebo
10973780|NCT00927927|OG009|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
10973781|NCT00927927|OG010|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
10973782|NCT00927927|OG011|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
10973783|NCT00927927|OG012|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
10973784|NCT00927927|OG013|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
10973785|NCT00927927|OG014|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
10973786|NCT00927927|EG000|Reported Event|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
10973787|NCT00927927|EG001|Reported Event|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
10825840|NCT00099372|BG001|Baseline|NO URETHROPEXY|Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
10973788|NCT00927927|EG002|Reported Event|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
10973789|NCT00927927|EG003|Reported Event|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
10973790|NCT00927927|EG004|Reported Event|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
10973791|NCT00927927|EG005|Reported Event|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
10973792|NCT00927927|EG006|Reported Event|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
10973793|NCT00927927|EG007|Reported Event|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
10973794|NCT00927927|EG008|Reported Event|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
10973795|NCT00927927|EG009|Reported Event|SD Placebo|Subjects were dosed once with placebo
10973796|NCT00927927|EG010|Reported Event|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
10973797|NCT00927927|EG011|Reported Event|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
10973798|NCT00927927|EG012|Reported Event|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
10973799|NCT00927927|EG013|Reported Event|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
10973800|NCT00927927|EG014|Reported Event|MD Placebo|Subjects were injected biweekly four times with placebo
10973801|NCT00927940|BG000|Baseline|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
10973802|NCT00927940|FG000|Participant Flow|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
10973803|NCT00927940|OG000|Outcome|Zotarolimus Eluting Stent|100 lesion of 100 ITT patients were subjected for this analysis.
10973804|NCT00927940|OG000|Outcome|Zotarolims Eluting Stent|
10973805|NCT00927940|EG000|Reported Event|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
10973806|NCT00927992|BG000|Baseline|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
10973807|NCT00927992|FG000|Participant Flow|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
10973808|NCT00927992|OG000|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
10973809|NCT00927992|EG000|Reported Event|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
10973810|NCT00928018|BG000|Baseline|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
11092681|NCT01541371|OG000|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
11092682|NCT01541371|OG000|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
10973811|NCT00928018|BG001|Baseline|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
10973812|NCT00928018|BG002|Baseline|Total|Total of all reporting groups
10973813|NCT00928018|FG000|Participant Flow|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
10973814|NCT00928018|FG001|Participant Flow|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
10973815|NCT00928018|OG000|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
10973816|NCT00928018|OG001|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
10973817|NCT00928018|OG000|Outcome|Indolent Group: Sirolimus-Containing Regimen|"Indolent group:indolent B-cell NHL, CLL and HL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
10973818|NCT00928018|OG001|Outcome|Indolent Group: Sirolimus-Free Regimen|"Indolent group: indolent B-cell NHL, CLL and HL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
10973819|NCT00928018|OG002|Outcome|Aggressive Group: Sirolimus-Containing Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
11092683|NCT01541371|EG000|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
11312937|NCT03192475|OG000|Outcome|Group Lifestyle Balance Plus Phone Contacts|"Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months~Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving."
11312938|NCT03192475|OG001|Outcome|Group Lifestyle Balance Plus Newsletter Contacts|"Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.~Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only."
10825841|NCT00099372|BG002|Baseline|Total|Total of all reporting groups
10825842|NCT00099372|FG000|Participant Flow|Abdominal Sacral Colpopexy With Burch Colposuspension|Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse
10825843|NCT00099372|FG001|Participant Flow|Abdominal Sacral Colpopexy With No Burch Colposuspension|Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
10825844|NCT00099372|OG000|Outcome|BURCH URETHROPEXY|Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse
10825845|NCT00099372|OG001|Outcome|NO URETHROPEXY|Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
10825846|NCT00099372|OG000|Outcome|BURCH URETHROPEXY|Abdominal Sacral Colpopexy with Burch Colposuspension
10825847|NCT00099372|OG001|Outcome|NO URETHROPEXY|Abdominal Sacral Colpopexy with No Burch Colposuspension
10825848|NCT00099372|EG000|Reported Event|Abdominal Sacral Colpopexy With Burch Colposuspension|Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse
10825849|NCT00099372|EG001|Reported Event|Abdominal Sacral Colpopexy With No Burch Colposuspension|Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
10825850|NCT00099632|BG000|Baseline|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
10825851|NCT00099632|BG001|Baseline|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
10825852|NCT00099632|BG002|Baseline|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
10825853|NCT00099632|BG003|Baseline|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
10825854|NCT00099632|BG004|Baseline|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
10825855|NCT00099632|BG005|Baseline|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
10825856|NCT00099632|BG006|Baseline|Total|Total of all reporting groups
10825857|NCT00099632|FG000|Participant Flow|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
10825858|NCT00099632|FG001|Participant Flow|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
10825859|NCT00099632|FG002|Participant Flow|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
10825860|NCT00099632|FG003|Participant Flow|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
10825861|NCT00099632|FG004|Participant Flow|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
10825862|NCT00099632|FG005|Participant Flow|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
10825863|NCT00099632|OG000|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
10825864|NCT00099632|OG001|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
10825865|NCT00099632|OG002|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
10825866|NCT00099632|OG003|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
10825867|NCT00099632|OG004|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
10825868|NCT00099632|OG005|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
10825869|NCT00099632|EG000|Reported Event|7-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
10825870|NCT00099632|EG001|Reported Event|21-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
10825871|NCT00099632|EG002|Reported Event|7-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
10825872|NCT00099632|EG003|Reported Event|21-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
10825873|NCT00099632|EG004|Reported Event|7-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
10825874|NCT00099632|EG005|Reported Event|21-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
10973820|NCT00928018|OG003|Outcome|Aggressive Group: Sirolimus-Free Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
10973821|NCT00928018|EG000|Reported Event|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
10973822|NCT00928018|EG001|Reported Event|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
10973823|NCT00928057|BG000|Baseline|4 mm / 8 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.
10973824|NCT00928057|BG001|Baseline|4 mm / 5 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.
10973825|NCT00928057|BG002|Baseline|Total|Total of all reporting groups
10973826|NCT00928057|FG000|Participant Flow|4 mm / 8 mm PN|This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
10973827|NCT00928057|FG001|Participant Flow|4 mm / 5 mm PN|This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
10973828|NCT00928057|OG000|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
10973829|NCT00928057|OG001|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
10973830|NCT00928057|OG000|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
10973831|NCT00928057|OG001|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
10973832|NCT00928057|OG002|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
10973833|NCT00928057|OG000|Outcome|4 mm PN|All randomized subjects that used the 4mm PN
10973834|NCT00928057|OG001|Outcome|5 mm PN|All randomized subjects that used the 5mm PN
10973835|NCT00928057|OG002|Outcome|8 mm PN|All randomized subjects that used the 8mm PN
10973836|NCT00928057|OG000|Outcome|4 mm PN|Use of 4 mm PN for insulin injections for 3 weeks.
10973837|NCT00928057|OG001|Outcome|5 mm PN|Use of 5 mm PN for insulin injections for 3 weeks.
10973838|NCT00928057|OG002|Outcome|8 mm PN|Use of 8 mm PN for insulin injections for 3 weeks.
10973839|NCT00928057|EG000|Reported Event|8mm PN|All randomized subjects that used the 8 mm pen needle.
10973840|NCT00928057|EG001|Reported Event|5mm PN|All randomized subjects that used the 5 mm pen needle.
10973841|NCT00928057|EG002|Reported Event|4mm PN|All randomized subjects that used the 4mm pen needle.
10973842|NCT00928070|BG000|Baseline|Placebo|Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
10973843|NCT00928070|BG001|Baseline|Fesoterodine|Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
10973844|NCT00928070|BG002|Baseline|Total|Total of all reporting groups
10973845|NCT00928070|FG000|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
10973846|NCT00928070|FG001|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
10973847|NCT00928070|OG000|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
10973848|NCT00928070|OG001|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
10825875|NCT00099983|BG000|Baseline|Risperidone|Risperidone : atypical antipsychotic
10825876|NCT00099983|BG001|Baseline|Sugar Pill|"PTSD~Placebo : Placebo"
10825877|NCT00099983|BG002|Baseline|Total|Total of all reporting groups
10825878|NCT00099983|FG000|Participant Flow|Risperidone|"an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette's disorder, pervasive developmental disorder and autism.~(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day)."
10825879|NCT00099983|FG001|Participant Flow|Sugar Pill|Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
10825880|NCT00099983|OG000|Outcome|Risperidone|"1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Risperidone: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time."
10825881|NCT00099983|OG001|Outcome|Sugar Pill|"Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Placebo: Placebo"
10825882|NCT00099983|EG000|Reported Event|Risperidone|Risperidone : atypical antipsychotic
10825883|NCT00099983|EG001|Reported Event|Sugar Pill|"PTSD~Placebo : Placebo"
10825884|NCT00100048|BG000|Baseline|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d"
10825885|NCT00100048|BG001|Baseline|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase (10 Days)~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine"
10825886|NCT00100048|BG002|Baseline|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine"
10825887|NCT00100048|BG003|Baseline|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine"
10825888|NCT00100048|BG004|Baseline|Placebo / Efavirenz 600 mg Once Daily (q.d.)|"Cohort I-Monotherapy Phase (10 Days)~Placebo to MK0518 b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks)~Efavirenz + Tenofovir + Lamivudine"
10825889|NCT00100048|BG005|Baseline|Total|Total of all reporting groups
10825890|NCT00100048|FG000|Participant Flow|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
10825891|NCT00100048|FG001|Participant Flow|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
10825892|NCT00100048|FG002|Participant Flow|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
10825893|NCT00100048|FG003|Participant Flow|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
10825894|NCT00100048|FG004|Participant Flow|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
10825895|NCT00100048|FG005|Participant Flow|Efavirenz 600 mg q.h.s.|"Cohort II Combined-Combination Therapy Phase~efavirenz 600 mg every night at bedtime (q.h.s.)"
10825896|NCT00100048|OG000|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
10825897|NCT00100048|OG001|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
10825898|NCT00100048|OG002|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
10825899|NCT00100048|OG003|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
10825900|NCT00100048|OG004|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
10825901|NCT00100048|OG001|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
10825902|NCT00100048|OG000|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
10825903|NCT00100048|OG001|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
10825904|NCT00100048|OG002|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
10825905|NCT00100048|OG003|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
10825906|NCT00100048|OG004|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
10825907|NCT00100048|OG000|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
10825908|NCT00100048|OG001|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
10825909|NCT00100048|OG002|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
10825910|NCT00100048|OG003|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
10825911|NCT00100048|OG004|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
10825912|NCT00100048|OG001|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
10973849|NCT00928070|EG000|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
10973850|NCT00928070|EG001|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
10973851|NCT00928083|BG000|Baseline|Part A - OZ439 Single Rising Dose|Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
10973852|NCT00928083|BG001|Baseline|Part B - OZ439 Food Effect|"Subjects were randomized to sequence groups, fasted/fed or fed/fasted while receiving a single dose of 800 mg OZ439."
10973853|NCT00928083|BG002|Baseline|Part C - OZ439 Multiple Rising Dose|Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
10973854|NCT00928083|BG003|Baseline|Total|Total of all reporting groups
10973855|NCT00928083|FG000|Participant Flow|Part A - OZ439 Single Dose - Cohort 1|OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
10973856|NCT00928083|FG001|Participant Flow|Part A - OZ439 Single Dose - Cohort 2|OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
10973857|NCT00928083|FG002|Participant Flow|Part A - OZ439 Single Dose - Cohort 3|Oral Dispersion OZ439 50-1600 mg
10973858|NCT00928083|FG003|Participant Flow|Part B - Food Effect - Cohort 1|Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
10973859|NCT00928083|FG004|Participant Flow|Part B - Food Effect - Cohort 2|Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
10973860|NCT00928083|FG005|Participant Flow|Part C - 200mg OZ439 Multiple Dose|200mg OZ439 for 3 consecutive days
10973861|NCT00928083|FG006|Participant Flow|Part C - 400mg OZ439 Multiple Dose|OZ439 400mg for 3 consecutive days
10973862|NCT00928083|FG007|Participant Flow|Part C - 800mg OZ439 Multiple Dose|OZ439 800mg for 3 consecutive days
10973863|NCT00928083|FG008|Participant Flow|Part C - Placebo|Part C - Placebo
10973864|NCT00928083|OG000|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
10973865|NCT00928083|OG001|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
10973866|NCT00928083|OG002|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
10973867|NCT00928083|OG003|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
10973868|NCT00928083|OG004|Outcome|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
10973869|NCT00928083|OG005|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
10973870|NCT00928083|OG006|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
10973871|NCT00928083|OG007|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
10973872|NCT00928083|OG008|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
10973873|NCT00928083|OG009|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
10973874|NCT00928083|OG010|Outcome|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
10973875|NCT00928083|OG011|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
10973876|NCT00928083|OG012|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
10973877|NCT00928083|OG013|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
10973878|NCT00928083|OG014|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
10973879|NCT00928083|OG015|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
10973880|NCT00928083|OG016|Outcome|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
10973881|NCT00928083|OG004|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
10973882|NCT00928083|OG005|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
10973883|NCT00928083|OG006|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
10973884|NCT00928083|OG007|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
10973885|NCT00928083|OG008|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
10973886|NCT00928083|OG009|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
10973887|NCT00928083|OG010|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
10973888|NCT00928083|OG011|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
10973889|NCT00928083|OG012|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
10973890|NCT00928083|OG013|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
10973891|NCT00928083|OG000|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
10973892|NCT00928083|OG001|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
10973893|NCT00928083|OG002|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
10973894|NCT00928083|EG000|Reported Event|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
10973895|NCT00928083|EG001|Reported Event|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
10973896|NCT00928083|EG002|Reported Event|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
10973897|NCT00928083|EG003|Reported Event|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
10973898|NCT00928083|EG004|Reported Event|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
10973899|NCT00928083|EG005|Reported Event|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
10973900|NCT00928083|EG006|Reported Event|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
10973901|NCT00928083|EG007|Reported Event|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
10973902|NCT00928083|EG008|Reported Event|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
10973903|NCT00928083|EG009|Reported Event|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
10973904|NCT00928083|EG010|Reported Event|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
10973905|NCT00928083|EG011|Reported Event|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
10973906|NCT00928083|EG012|Reported Event|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
10973907|NCT00928083|EG013|Reported Event|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
10973908|NCT00928083|EG014|Reported Event|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
10973909|NCT00928083|EG015|Reported Event|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
10973910|NCT00928083|EG016|Reported Event|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
10973911|NCT00928135|BG000|Baseline|Hypertonic Saline|7% hypertonic saline given twice daily for 14 days
10973912|NCT00928135|BG001|Baseline|Xylitol|Xylitol given twice daily for 14 days
10973913|NCT00928135|BG002|Baseline|Total|Total of all reporting groups
10973914|NCT00928135|FG000|Participant Flow|7% Hypertonic Saline|"5 ml of 7% saline twice daily~Saline: 7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973915|NCT00928135|FG001|Participant Flow|Hypertonic Xylitol|"5 ml of 15% xylitol twice daily~Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973916|NCT00928135|OG000|Outcome|7% Hypertonic Saline|"5 ml of 7% saline twice daily~Saline: 7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973917|NCT00928135|OG001|Outcome|Hypertonic Xylitol|"5 ml of 15% xylitol twice daily~Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973918|NCT00928135|EG000|Reported Event|7% Hypertonic Saline|"5 ml of 7% saline twice daily~Saline: 7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973919|NCT00928135|EG001|Reported Event|Hypertonic Xylitol|"5 ml of 15% xylitol twice daily~Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)"
10973920|NCT00928174|BG000|Baseline|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
10973921|NCT00928174|FG000|Participant Flow|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
10973922|NCT00928174|OG000|Outcome|Single Arm|"fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
10973923|NCT00928174|EG000|Reported Event|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
10973924|NCT00928187|BG000|Baseline|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
10973925|NCT00928187|BG001|Baseline|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
10973926|NCT00928187|BG002|Baseline|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
10973927|NCT00928187|BG003|Baseline|Total|Total of all reporting groups
10973928|NCT00928187|FG000|Participant Flow|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
10825913|NCT00100048|OG000|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
10825914|NCT00100048|OG001|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
10825915|NCT00100048|OG000|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
10825916|NCT00100048|OG001|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
10825917|NCT00100048|EG000|Reported Event|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
10825918|NCT00100048|EG001|Reported Event|Efavirenz|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
10825919|NCT00100165|BG000|Baseline|DMXB-A 75, Then DMXB- 150, Then Placebo|"Overall number of baseline participants 10~Age, continuous"
10825920|NCT00100165|BG001|Baseline|Placebo, Then DMXB-A 75, Then DMXB-A 150|"Overall number of baseline participants 10~Age , continuous"
10825921|NCT00100165|BG002|Baseline|DMXB-A 150, Then Placebo, Then DMXB-A 75|"Overall number of baseline participants 9~Age, continuous"
10825922|NCT00100165|BG003|Baseline|Total|Total of all reporting groups
10825923|NCT00100165|FG000|Participant Flow|Placebo, Then DMXB-A 75, Then DMXB-A 150|Placebo then 3-(2,4-dimethoxybenzylidene) anabaseine 75 mg then 3-(2,4-dimethoxybenzylidene) anabaseine 150 mg
10825924|NCT00100165|FG001|Participant Flow|DMXB-A 75, Then DMXB-A 150, Then Placebo|3-(2,4-dimethoxybenzylidene) anabaseine 75 mg,then 3-(2,4-dimethoxybenzylidene) anabaseine 150 mg, then placebo
10825925|NCT00100165|FG002|Participant Flow|DMXB-A 150 mg, Then Placebo, Then DMXB-A 75|3-(2,4-dimethoxybenzylidene) anabaseine 150 mg, then placebo, then 3-(2,4-dimethoxybenzylidene) anabaseine 75 mg
10825926|NCT00100165|OG000|Outcome|Placebo|Change in t-score from baseline performance on neurocognitive measures when taking placebo for 4 weeks
10825927|NCT00100165|OG001|Outcome|3-(2,4-dimethoxybenzylidene) Anabaseine 75 mg|Change in t-scores from baseline neurocognitive performance when taking 3-(2,4-dimethoxybenzylidene) anabaseine 75 mg p.o. BID for 4 weeks
10825928|NCT00100165|OG002|Outcome|3-(2,4-dimethoxybenzylidene) Anabaseine 150 mg|Change in t-scores from baseline neurocognitive performance when taking3-(2,4-dimethoxybenzylidene) anabaseine 150 mg p.o BID for 4 weeks
10825929|NCT00100165|OG000|Outcome|3-2,4 Dimethoxybenzylidene 75 mg|change in total scale for the assessment of negative symptoms at baseline after taking 3-2,4 dimethoxybenzylidene 75 mg BID for 4 weeks
10825930|NCT00100165|OG001|Outcome|3-2,4 Dimethoxybenzylidene 150 mg|change in total scale for the assessment of negative symptoms at baseline after taking 3-2,4 dimethoxybenzylidene BID 150 mg for 4 weeks
10825931|NCT00100165|OG002|Outcome|Placebo|change in total scale for the assessment of negative symptoms at baseline after taking placebo BID for 4 weeks
10825932|NCT00100165|EG000|Reported Event|DMXB-A 75 mg|3-(2,4 dimethoxybenzylidene) 75 mg p.o. BID for 4 weeks
10825933|NCT00100165|EG001|Reported Event|DMXBA 150 mg|3-(2,4 dimethoxybenzylidene) 150 mg p.o. BID for 4 weeks
10825934|NCT00100165|EG002|Reported Event|Placebo|Placebo p.o. BID for 4 weeks
10825935|NCT00100178|BG000|Baseline|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
10825936|NCT00100178|BG001|Baseline|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
10825937|NCT00100178|BG002|Baseline|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
10825938|NCT00100178|BG003|Baseline|Total|Total of all reporting groups
10825939|NCT00100178|FG000|Participant Flow|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
10825940|NCT00100178|FG001|Participant Flow|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
10825941|NCT00100178|FG002|Participant Flow|MMF-DZB Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
10825942|NCT00100178|OG000|Outcome|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
10825943|NCT00100178|OG001|Outcome|Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
10825944|NCT00100178|OG002|Outcome|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
10825945|NCT00100178|EG000|Reported Event|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later .
10825946|NCT00100178|EG001|Reported Event|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
10825947|NCT00100178|EG002|Reported Event|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
10825948|NCT00100230|BG000|Baseline|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
10825949|NCT00100230|BG001|Baseline|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
10825950|NCT00100230|BG002|Baseline|Total|Total of all reporting groups
10973929|NCT00928187|FG001|Participant Flow|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
10973930|NCT00928187|FG002|Participant Flow|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
10973931|NCT00928187|OG000|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
10973932|NCT00928187|OG001|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
10973933|NCT00928187|OG002|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
10973934|NCT00928187|EG000|Reported Event|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
10973935|NCT00928187|EG001|Reported Event|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
10973936|NCT00928187|EG002|Reported Event|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
10973937|NCT00928200|BG000|Baseline|Single Arm|"All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.~Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.~Erwinase will be administered as a 2-hour intravenous infusion.~Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22~Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.~Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1~Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3"
10973938|NCT00928200|FG000|Participant Flow|Single Arm|"All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.~Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.~Erwinase will be administered as a 2-hour intravenous infusion.~Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22~Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.~Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1~Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3"
10973939|NCT00928200|OG000|Outcome|Single Arm|"All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.~Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.~Erwinase will be administered as a 2-hour intravenous infusion.~Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22~Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.~Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1~Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3"
10973940|NCT00928200|EG000|Reported Event|Single Arm|"All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.~Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.~Erwinase will be administered as a 2-hour intravenous infusion.~Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22~Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.~Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1~Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3"
10973941|NCT00928252|BG000|Baseline|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
10973942|NCT00928252|FG000|Participant Flow|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
10973943|NCT00928252|OG000|Outcome|Received 18F-fluorocholine PET/CT|"IV fluorine-18 labeled methylcholine before PET/CT~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
10973944|NCT00928252|OG000|Outcome|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
10973945|NCT00928252|OG000|Outcome|Positive Metabolically Active Tumor Response|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. Positive Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
10973946|NCT00928252|EG000|Reported Event|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
10973947|NCT00928304|BG000|Baseline|Subjects Enrolled in Study|All Down Syndrome and healthy volunteer subjects
10973948|NCT00928304|FG000|Participant Flow|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
10973949|NCT00928304|FG001|Participant Flow|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
10973950|NCT00928304|OG000|Outcome|Majority Read|Majority read of the visual assessment made by 3 independent readers of PET images from all subjects.
10973951|NCT00928304|OG000|Outcome|Majority Read (DS-Young)|Majority Read results for Down Syndrome subjects with age <= 46 yrs
10973952|NCT00928304|OG001|Outcome|Majority Read (DS-Old)|Majority Read results for Down Syndrome subjects with age >46 yrs
10973953|NCT00928304|OG000|Outcome|Down Syndrome Group|Subjects with Down Syndrome enrolled in the study
10973954|NCT00928304|OG001|Outcome|Healthy Volunteer Group|Healthy volunteers enrolled in the study
10973955|NCT00928304|OG000|Outcome|Down Syndrome PET-positive (Majority Read)|Down Syndrome subjects positive for cerebral beta-amyloid as determined by majority read
10973956|NCT00928304|OG001|Outcome|Down Syndrome PET-negative (Majority Read)|Down Syndrome subjects negative for cerebral beta-amyloid as determined by majority read
10973957|NCT00928304|OG002|Outcome|Healthy Volunteer Group|All healthy volunteers enrolled in the study
10973958|NCT00928304|EG000|Reported Event|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
10973959|NCT00928304|EG001|Reported Event|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
10973960|NCT00928395|BG000|Baseline|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10973961|NCT00928395|FG000|Participant Flow|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10973962|NCT00928395|OG000|Outcome|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10973963|NCT00928395|EG000|Reported Event|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
10973964|NCT00928408|BG000|Baseline|Cinacalcet|
10973965|NCT00928408|FG000|Participant Flow|Cinacalcet|
10973966|NCT00928408|OG000|Outcome|Cinacalcet|
10973967|NCT00928408|EG000|Reported Event|Cinacalcet|
10973968|NCT00928421|BG000|Baseline|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
10973969|NCT00928421|FG000|Participant Flow|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
10973970|NCT00928421|OG000|Outcome|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
10973971|NCT00928421|EG000|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
10973972|NCT00928434|BG000|Baseline|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973973|NCT00928434|BG001|Baseline|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973974|NCT00928434|BG002|Baseline|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"
10973975|NCT00928434|BG003|Baseline|Total|Total of all reporting groups
10973976|NCT00928434|FG000|Participant Flow|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973977|NCT00928434|FG001|Participant Flow|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973978|NCT00928434|FG002|Participant Flow|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
10973979|NCT00928434|OG000|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973980|NCT00928434|OG001|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
10973981|NCT00928434|OG000|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973982|NCT00928434|OG001|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973983|NCT00928434|OG002|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
10973984|NCT00928434|OG001|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
11312939|NCT03192475|OG001|Outcome|GLB Plus Newsletter Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.~GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only."
10825951|NCT00100230|FG000|Participant Flow|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
10825952|NCT00100230|FG001|Participant Flow|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
10825953|NCT00100230|OG000|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
10825954|NCT00100230|OG001|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
10825955|NCT00100230|OG000|Outcome|DHA (Docosahexaenoic Acid) ARM|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
10825956|NCT00100230|OG001|Outcome|Placebo (Corn/Soy Oil) ARM|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
10825957|NCT00100230|EG000|Reported Event|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
10825958|NCT00100230|EG001|Reported Event|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
10825959|NCT00100659|BG000|Baseline|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
10825960|NCT00100659|BG001|Baseline|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
10825961|NCT00100659|BG002|Baseline|Total|Total of all reporting groups
10825962|NCT00100659|FG000|Participant Flow|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
10825963|NCT00100659|FG001|Participant Flow|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin (RV), using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
10825964|NCT00100659|OG000|Outcome|PEG/RV|Pegylated interferon/ribavirin
10825965|NCT00100659|OG001|Outcome|PEG/Placebo|Pegylated interferon/placebo
10825966|NCT00100659|OG000|Outcome|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets.~Pegylated Interferon/ribavirin"
10825967|NCT00100659|OG001|Outcome|Pegylated Interferon/Placebo|"Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).~Pegylated Interferon/ribavirin"
10825968|NCT00100659|EG000|Reported Event|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
10825969|NCT00100659|EG001|Reported Event|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
10825970|NCT00100698|BG000|Baseline|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
10825971|NCT00100698|BG001|Baseline|Placebo|placebo subcutaneously once a day
10825972|NCT00100698|BG002|Baseline|Total|Total of all reporting groups
10825973|NCT00100698|FG000|Participant Flow|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
10825974|NCT00100698|FG001|Participant Flow|Placebo|placebo subcutaneously once a day
10825975|NCT00100698|OG000|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
10825976|NCT00100698|OG001|Outcome|Placebo|placebo subcutaneously once a day
10825977|NCT00100698|EG000|Reported Event|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
10825978|NCT00100698|EG001|Reported Event|Placebo|placebo subcutaneously once a day
10825979|NCT00100789|BG000|Baseline|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
10825980|NCT00100789|FG000|Participant Flow|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
10825981|NCT00100789|OG000|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
10825982|NCT00100789|OG000|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
10825983|NCT00100789|EG000|Reported Event|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
10825984|NCT00100802|BG000|Baseline|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
10825985|NCT00100802|FG000|Participant Flow|Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
10825986|NCT00100802|OG000|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
10825987|NCT00100802|EG000|Reported Event|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
10825988|NCT00100815|BG000|Baseline|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
10825989|NCT00100815|FG000|Participant Flow|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
10825990|NCT00100815|OG000|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
10825991|NCT00100815|EG000|Reported Event|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
10825992|NCT00100841|BG000|Baseline|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10825993|NCT00100841|FG000|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10825994|NCT00100841|OG000|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10825995|NCT00100841|EG000|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
10825996|NCT00100932|BG000|Baseline|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10825997|NCT00100932|BG001|Baseline|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10825998|NCT00100932|BG002|Baseline|Total|Total of all reporting groups
10825999|NCT00100932|FG000|Participant Flow|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10826000|NCT00100932|FG001|Participant Flow|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10826001|NCT00100932|OG000|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10826002|NCT00100932|OG001|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10826003|NCT00100932|EG000|Reported Event|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
10826004|NCT00100932|EG001|Reported Event|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
10826005|NCT00101010|BG000|Baseline|Rituximab - Combination Chemotherapy|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, & oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
10826006|NCT00101010|FG000|Participant Flow|Rituximab - Combination Chemotherapy|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, & oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
10826007|NCT00101010|OG000|Outcome|Rituximab - Combination Chemotherapy|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, & oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
10826008|NCT00101010|EG000|Reported Event|Rituximab - Combination Chemotherapy|Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, & oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
10826009|NCT00101036|BG000|Baseline|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
10826010|NCT00101036|BG001|Baseline|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
10826011|NCT00101036|BG002|Baseline|Total|Total of all reporting groups
10826012|NCT00101036|FG000|Participant Flow|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
10826013|NCT00101036|FG001|Participant Flow|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
10826014|NCT00101036|OG000|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
10826015|NCT00101036|OG001|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
10826016|NCT00101036|EG000|Reported Event|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
10826017|NCT00101036|EG001|Reported Event|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
10826018|NCT00101101|BG000|Baseline|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
10826019|NCT00101101|FG000|Participant Flow|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
10826020|NCT00101101|OG000|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
10826021|NCT00101101|EG000|Reported Event|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
10848548|NCT00290355|BG001|Baseline|Placebo Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
10973985|NCT00928434|OG002|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
10973986|NCT00928434|OG003|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
10973987|NCT00928434|OG001|Outcome|DC (Degarelix Continuous)|"administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973988|NCT00928434|OG001|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973989|NCT00928434|OG000|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973990|NCT00928434|EG000|Reported Event|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
10973991|NCT00928434|EG001|Reported Event|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
10973992|NCT00928434|EG002|Reported Event|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
10973993|NCT00928486|BG000|Baseline|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
10973994|NCT00928486|FG000|Participant Flow|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
10973995|NCT00928486|OG000|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
10973996|NCT00928486|EG000|Reported Event|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
10973997|NCT00928512|BG000|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
10973998|NCT00928512|BG001|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
10973999|NCT00928512|BG002|Baseline|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
10974000|NCT00928512|BG003|Baseline|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
10826022|NCT00101166|BG000|Baseline|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
10826023|NCT00101166|FG000|Participant Flow|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
10826024|NCT00101166|OG000|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
10826025|NCT00101166|EG000|Reported Event|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
10826026|NCT00101192|BG000|Baseline|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
10826027|NCT00101192|FG000|Participant Flow|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
10826028|NCT00101192|OG000|Outcome|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
10826029|NCT00101192|EG000|Reported Event|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
10826030|NCT00101283|BG000|Baseline|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
10826031|NCT00101283|BG001|Baseline|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
10826032|NCT00101283|BG002|Baseline|Total|Total of all reporting groups
10826033|NCT00101283|FG000|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
10826034|NCT00101283|FG001|Participant Flow|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
10826035|NCT00101283|OG000|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
10826036|NCT00101283|OG001|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
10826037|NCT00101283|EG000|Reported Event|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
10826038|NCT00101283|EG001|Reported Event|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
10826039|NCT00101361|BG000|Baseline|Oxandrolone|Oxandrolone
10826040|NCT00101361|BG001|Baseline|Placebo|placebo
10826041|NCT00101361|BG002|Baseline|Total|Total of all reporting groups
10826042|NCT00101361|FG000|Participant Flow|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
10826043|NCT00101361|FG001|Participant Flow|2 Placebo|placebo - two capsules twice daily
10826044|NCT00101361|OG000|Outcome|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
10826045|NCT00101361|OG001|Outcome|2 Placebo|placebo - two capsules twice daily
10826046|NCT00101361|EG000|Reported Event|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
10826047|NCT00101361|EG001|Reported Event|2 Placebo|placebo - two capsules twice daily
10826048|NCT00101400|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
10826049|NCT00101400|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
10826050|NCT00101400|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
10826051|NCT00101400|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
10826052|NCT00101413|BG000|Baseline|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
10826053|NCT00101413|FG000|Participant Flow|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
10826054|NCT00101413|OG000|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
10826055|NCT00101413|EG000|Reported Event|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
10826056|NCT00101452|BG000|Baseline|1. SAMe|a naturally occurring substance
10826057|NCT00101452|BG001|Baseline|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
10826058|NCT00101452|BG002|Baseline|3. Placebo|Sugar Pill- contains no active ingrediants
10826059|NCT00101452|BG003|Baseline|Total|Total of all reporting groups
10974001|NCT00928512|BG004|Baseline|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
10974002|NCT00928512|BG005|Baseline|Total|Total of all reporting groups
10974003|NCT00928512|FG000|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
10974004|NCT00928512|FG001|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
10974005|NCT00928512|FG002|Participant Flow|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
10974006|NCT00928512|FG003|Participant Flow|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
10974007|NCT00928512|FG004|Participant Flow|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
10974008|NCT00928512|OG000|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
10974009|NCT00928512|OG001|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
10974010|NCT00928512|OG002|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
10974011|NCT00928512|OG003|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
10974012|NCT00928512|OG004|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
10974013|NCT00928512|EG000|Reported Event|AIN457 25mg|Up to Week 20 - AIN457 25mg
10974014|NCT00928512|EG001|Reported Event|AIN457 75mg|Up to Week 20 - AIN457 75mg
10974015|NCT00928512|EG002|Reported Event|AIN457 150mg|Up to Week 20 - AIN457 150mg
10974016|NCT00928512|EG003|Reported Event|AIN457 300mg|Up to Week 20 - AIN457 300mg
10974017|NCT00928512|EG004|Reported Event|Placebo|Up to Week 20 - Placebo
10974018|NCT00928512|EG005|Reported Event|AIN457 25mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 25mg
10974019|NCT00928512|EG006|Reported Event|AIN457 75mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 75mg
10974020|NCT00928512|EG007|Reported Event|AIN457 150mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 150mg
10974021|NCT00928512|EG008|Reported Event|AIN457 300mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 300mg
10974022|NCT00928564|BG000|Baseline|Pudendal Block|"8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.~Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site."
10974023|NCT00928564|BG001|Baseline|Placebo|"5ml of saline at each block site~Placebo: 5ml of saline at each block site."
10974024|NCT00928564|BG002|Baseline|Total|Total of all reporting groups
10974025|NCT00928564|FG000|Participant Flow|Pudendal Block|"8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.~Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site."
10974026|NCT00928564|FG001|Participant Flow|Placebo|"5ml of saline at each block site~Placebo: 5ml of saline at each block site."
10974027|NCT00928564|OG000|Outcome|Pudendal Block|"8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.~Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site."
10974028|NCT00928564|OG001|Outcome|Placebo|"5ml of saline at each block site~Placebo: 5ml of saline at each block site."
10974029|NCT00928564|EG000|Reported Event|Pudendal Block|"8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.~Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site."
10974030|NCT00928564|EG001|Reported Event|Placebo|"5ml of saline at each block site~Placebo: 5ml of saline at each block site."
10974031|NCT00928642|BG000|Baseline|Treatment|Open label, non-randomized, single treatment group.
10974032|NCT00928642|FG000|Participant Flow|Oral Imatinib Plus Gemcitabine|Open label, non-randomized, single treatment group.
10974033|NCT00928642|OG000|Outcome|Oral Imatinib Plus Gemcitabine|"Open label, non-randomized, single treatment group.~All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine."
10974034|NCT00928642|OG000|Outcome|Oral Imatinib Puls IV Gemcitabine|Open label, non-randomized, single treatment group.
10974035|NCT00928642|OG000|Outcome|Oral Imatinib Plus IV Gemcitabine|Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.
10974036|NCT00928642|OG000|Outcome|Treatment|Open label, non-randomized, single treatment group.
10974037|NCT00928642|EG000|Reported Event|Treatment|Open label, non-randomized, single treatment group.
10974038|NCT00928668|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
10974039|NCT00928668|FG000|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
10974040|NCT00928668|FG001|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
10974041|NCT00928668|FG002|Participant Flow|Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
11312940|NCT03192475|EG000|Reported Event|GLB Plus Phone Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months~GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving."
11312941|NCT03192475|EG001|Reported Event|GLB Plus Newsletter Contacts|"GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.~GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only."
10826060|NCT00101452|FG000|Participant Flow|1. SAMe|Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
10826061|NCT00101452|FG001|Participant Flow|2. Escitalopram|Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
10826062|NCT00101452|FG002|Participant Flow|3. Placebo|Placebo is a non-active treatment, sometimes called a sugar pill.
10826063|NCT00101452|OG000|Outcome|1. SAMe|a naturally occurring substance
10826064|NCT00101452|OG001|Outcome|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
10826065|NCT00101452|OG002|Outcome|3. Placebo|Sugar Pill- contains no active ingrediants
10826066|NCT00101452|EG000|Reported Event|1. SAMe (Weeks 1-12)|A naturally occurring substance (S-adenosyl methionine)
10826067|NCT00101452|EG001|Reported Event|2. Escitalopram (Weeks 1-12)|A selective serotonin reuptake inhibitor (SSRI)
10826068|NCT00101452|EG002|Reported Event|3. Placebo (Weeks 1-12)|Sugar Pill- contains no active ingredients
10826069|NCT00101452|EG003|Reported Event|4. SAMe (Weeks 12-24, Continuation)|A naturally occurring substance (S-adenosyl methionine)
10826070|NCT00101452|EG004|Reported Event|5. Escitalopram (Weeks 12-24, Continuation)|A selective serotonin reuptake inhibitor (SSRI)
10826071|NCT00101452|EG005|Reported Event|6. Placebo (Weeks 12-24, Continuation)|Sugar Pill- contains no active ingredients
10826072|NCT00101452|EG006|Reported Event|7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)|A naturally occurring substance (S-adenosyl methionine) plus a selective serotonin reuptake inhibitor (SSRI)
10826073|NCT00101582|BG000|Baseline|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
10826074|NCT00101582|BG001|Baseline|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
10826075|NCT00101582|BG002|Baseline|Total|Total of all reporting groups
10826076|NCT00101582|FG000|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
10826077|NCT00101582|FG001|Participant Flow|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
10826078|NCT00101582|OG000|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
10826079|NCT00101582|OG001|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
10826080|NCT00101582|EG000|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
10826081|NCT00101582|EG001|Reported Event|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
10826082|NCT00101647|BG000|Baseline|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
10826083|NCT00101647|BG001|Baseline|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
10826084|NCT00101647|BG002|Baseline|Total|Total of all reporting groups
10826085|NCT00101647|FG000|Participant Flow|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
10848549|NCT00290355|BG002|Baseline|Total|Total of all reporting groups
10974042|NCT00928668|FG003|Participant Flow|Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
10974043|NCT00928668|FG004|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg|Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
10974044|NCT00928668|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
10974045|NCT00928668|OG001|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
10974046|NCT00928668|OG002|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
10974047|NCT00928668|OG003|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
10974048|NCT00928668|OG004|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
10974049|NCT00928668|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974050|NCT00928668|OG001|Outcome|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10974051|NCT00928668|OG002|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974052|NCT00928668|OG003|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974053|NCT00928668|OG004|Outcome|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
10974054|NCT00928668|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974055|NCT00928668|EG001|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
10974056|NCT00928668|EG002|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974057|NCT00928668|EG003|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974058|NCT00928668|EG004|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
10974059|NCT00928694|BG000|Baseline|All Participants|
10974060|NCT00928694|FG000|Participant Flow|TRICOR™ First, Then SUPRALIP™|U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet
10974061|NCT00928694|FG001|Participant Flow|SUPRALIP™ First, Then TRICOR™|UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
10974062|NCT00928694|OG000|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
10974063|NCT00928694|OG001|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
10974064|NCT00928694|EG000|Reported Event|Tricor™|U.S. formulation (TRICOR™) 160 mg tablet
10974065|NCT00928694|EG001|Reported Event|Supralip™|UK formulation (SUPRALIP™) 160 mg tablet
10974066|NCT00928707|BG000|Baseline|GIVINOSTAT + MTD Hydroxyurea_1|"50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy"
10974067|NCT00928707|BG001|Baseline|GIVINOSTAT + MTD Hydroxyurea_2|"50 mg b.i.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy"
10974068|NCT00928707|BG002|Baseline|Total|Total of all reporting groups
10974069|NCT00928707|FG000|Participant Flow|GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_1|"50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of hydroxyurea (HU) monotherapy~GIVINOSTAT (ITF2357) 50 mg o.d. + maximum tolerated dose (MTD) of Hydroxyurea (HU): 50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy"
10974070|NCT00928707|FG001|Participant Flow|GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_2|"50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy~GIVINOSTAT (ITF2357) 50 mg b.i.d. + maximum tolerated dose (MTD) of Hydroxyurea (HU): 50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy"
10974071|NCT00928707|OG000|Outcome|GIVINOSTAT + MTD Hydroxyurea_1|"50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy"
10974072|NCT00928707|OG001|Outcome|GIVINOSTAT + MTD Hydroxyurea_2|"50 mg b.i.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy"
10974073|NCT00928707|EG000|Reported Event|GIVINOSTAT + MTD Hydroxyurea_1|"50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy"
10974074|NCT00928707|EG001|Reported Event|GIVINOSTAT + MTD Hydroxyurea_2|"50 mg b.i.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy"
10974075|NCT00928720|BG000|Baseline|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
10974076|NCT00928720|BG001|Baseline|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
10974077|NCT00928720|BG002|Baseline|Usual Care Alone|No intervention; participants will received usual medical care for fibromyalgia
10974078|NCT00928720|BG003|Baseline|Total|Total of all reporting groups
10974079|NCT00928720|FG000|Participant Flow|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
10974080|NCT00928720|FG001|Participant Flow|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
10974081|NCT00928720|FG002|Participant Flow|Usual Care Alone|No intervention; usual medical care for fibromyalgia
10974082|NCT00928720|OG000|Outcome|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
10974083|NCT00928720|OG001|Outcome|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
10974084|NCT00928720|OG002|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
10974085|NCT00928720|OG000|Outcome|CES Device|"Participants will use the device for 60 minutes each day for 8 weeks.~CES device: Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM."
10974086|NCT00928720|OG002|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care
10974087|NCT00928720|OG002|Outcome|Usual Care Alone|No intervention; usual medical care for fibromyalgia
10974088|NCT00928720|EG000|Reported Event|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
10974089|NCT00928720|EG001|Reported Event|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
10974090|NCT00928720|EG002|Reported Event|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
10974091|NCT00928746|BG000|Baseline|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
10974092|NCT00928746|FG000|Participant Flow|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
10974093|NCT00928746|OG000|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
10974094|NCT00928746|OG000|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg - Oral inhalation) - 180 Actuations group
10974095|NCT00928746|OG000|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
10974096|NCT00928746|EG000|Reported Event|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
10974097|NCT00928772|BG000|Baseline|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
10974098|NCT00928772|BG001|Baseline|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
10974099|NCT00928772|BG002|Baseline|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
10974100|NCT00928772|BG003|Baseline|Total|Total of all reporting groups
10974101|NCT00928772|FG000|Participant Flow|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
10974102|NCT00928772|FG001|Participant Flow|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
10974103|NCT00928772|FG002|Participant Flow|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
10974104|NCT00928772|OG000|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
10974105|NCT00928772|OG001|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
10974106|NCT00928772|OG002|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
10974107|NCT00928772|EG000|Reported Event|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
10974108|NCT00928772|EG001|Reported Event|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
10974109|NCT00928772|EG002|Reported Event|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
10974110|NCT00928889|BG000|Baseline|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
10974111|NCT00928889|BG001|Baseline|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
10974112|NCT00928889|BG002|Baseline|Total|Total of all reporting groups
10974113|NCT00928889|FG000|Participant Flow|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
10974114|NCT00928889|FG001|Participant Flow|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
10974115|NCT00928889|OG000|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
10974116|NCT00928889|OG001|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
10974117|NCT00928889|EG000|Reported Event|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
10974118|NCT00928889|EG001|Reported Event|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
10974119|NCT00928954|BG000|Baseline|All Study Participants|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
10974120|NCT00928954|FG000|Participant Flow|Gabapentin First and Then Memantine|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
10974121|NCT00928954|FG001|Participant Flow|Memantine First, Then Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
10974122|NCT00928954|OG000|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
10974123|NCT00928954|OG001|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
10974124|NCT00928954|EG000|Reported Event|Gabapentin|Increasing dose to 300 mg four times per day (total of 1200 mg/day)
10974125|NCT00928954|EG001|Reported Event|Memantine|Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
10974126|NCT00929071|BG000|Baseline|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
10974127|NCT00929071|FG000|Participant Flow|All Study Participants|Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
10974128|NCT00929071|OG000|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic left nasolabial fold~collagen: Injectable collagen~topical anesthetic"
10974129|NCT00929071|OG001|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine right nasolabial fold~collagen: Injectable collagen~Lidocaine: admix anesthetic"
10974130|NCT00929071|OG000|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic~collagen: Injectable collagen~topical anesthetic"
10974131|NCT00929071|OG001|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine~collagen: Injectable collagen~Lidocaine: admix anesthetic"
10974132|NCT00929071|EG000|Reported Event|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
10974133|NCT00929110|BG000|Baseline|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974134|NCT00929110|BG001|Baseline|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974135|NCT00929110|BG002|Baseline|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974136|NCT00929110|BG003|Baseline|Total|Total of all reporting groups
10974137|NCT00929110|FG000|Participant Flow|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974138|NCT00929110|FG001|Participant Flow|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974139|NCT00929110|FG002|Participant Flow|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974140|NCT00929110|OG000|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974141|NCT00929110|OG001|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974142|NCT00929110|OG002|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974143|NCT00929110|EG000|Reported Event|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974144|NCT00929110|EG001|Reported Event|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974145|NCT00929110|EG002|Reported Event|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
10974146|NCT00929162|BG000|Baseline|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974147|NCT00929162|BG001|Baseline|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974148|NCT00929162|BG002|Baseline|Total|Total of all reporting groups
10974149|NCT00929162|FG000|Participant Flow|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974150|NCT00929162|FG001|Participant Flow|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974151|NCT00929162|OG000|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974152|NCT00929162|OG001|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974153|NCT00929162|EG000|Reported Event|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974154|NCT00929162|EG001|Reported Event|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
10974155|NCT00929201|BG000|Baseline|All Participants|All randomized participants
10974156|NCT00929201|FG000|Participant Flow|Sita + Met Then Sita/Met FDC|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
10974157|NCT00929201|FG001|Participant Flow|Sita/Met FDC Then Sita + Met|Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
10974158|NCT00929201|OG000|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
10974159|NCT00929201|OG001|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
11312942|NCT03192488|BG000|Baseline|Subjects Completing All 3 Study Arms|Completed: Hypoxia/ Cetirizine (14.3% oxygen with 10mg cetirizine), Hypoxia/ Placebo (21% oxygen with gelatin placebo), and Normoxia/Placebo (21% oxygen with gelatin placebo)
10974160|NCT00929201|OG001|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
10974161|NCT00929201|EG000|Reported Event|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
10974162|NCT00929201|EG001|Reported Event|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
10974163|NCT00929240|BG000|Baseline|Intial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
10974164|NCT00929240|FG000|Participant Flow|Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel|During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
10974165|NCT00929240|FG001|Participant Flow|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
10974166|NCT00929240|FG002|Participant Flow|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
10974167|NCT00929240|OG000|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
10974168|NCT00929240|OG001|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
10974169|NCT00929240|OG000|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
10974170|NCT00929240|OG000|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
10974171|NCT00929240|EG000|Reported Event|Initial Treatment Phase:Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
10974172|NCT00929240|EG001|Reported Event|Maintenance Phase:Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
11312943|NCT03192488|FG000|Participant Flow|Cetirizine/Hypoxia, Placebo/Hypoxia, Placebo/Normoxia|"During the first visit, subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen)."
10974173|NCT00929240|EG002|Reported Event|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
10974174|NCT00929305|BG000|Baseline|Placebo Laser|inactive laser light
10974175|NCT00929305|BG001|Baseline|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
10974176|NCT00929305|BG002|Baseline|Total|Total of all reporting groups
10974177|NCT00929305|FG000|Participant Flow|Placebo Laser|inactive laser light
10974178|NCT00929305|FG001|Participant Flow|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
10974179|NCT00929305|OG000|Outcome|Placebo Laser|inactive laser light
10974180|NCT00929305|OG001|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
10974181|NCT00929305|OG001|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
10974182|NCT00929305|EG000|Reported Event|Placebo Laser|inactive laser light
10974183|NCT00929305|EG001|Reported Event|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
10974184|NCT00929331|BG000|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974185|NCT00929331|BG001|Baseline|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974186|NCT00929331|BG002|Baseline|Total|Total of all reporting groups
10974187|NCT00929331|FG000|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974188|NCT00929331|FG001|Participant Flow|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974189|NCT00929331|OG000|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974190|NCT00929331|OG001|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974191|NCT00929331|EG000|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974192|NCT00929331|EG001|Reported Event|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
10974193|NCT00929344|BG000|Baseline|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974194|NCT00929344|BG001|Baseline|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974195|NCT00929344|BG002|Baseline|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974196|NCT00929344|BG003|Baseline|Total|Total of all reporting groups
10974197|NCT00929344|FG000|Participant Flow|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974198|NCT00929344|FG001|Participant Flow|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974199|NCT00929344|FG002|Participant Flow|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974200|NCT00929344|OG000|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10826086|NCT00101647|FG001|Participant Flow|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
10826087|NCT00101647|OG000|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
10826088|NCT00101647|OG001|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
10826089|NCT00101647|OG002|Outcome|Total|
10826090|NCT00101647|OG000|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
10826091|NCT00101647|OG000|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
10826092|NCT00101647|OG001|Outcome|Total|
10826093|NCT00101647|OG000|Outcome|Participants Achieving MaHR|Percentage of participants achieving MaHR, defined as best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
10826094|NCT00101647|OG001|Outcome|Participants Achieving MCyR|Percentage of participants achieving major cytogenetic response (MCyR), defined as the rate of complete cytogenetic response (CCyR) plus the rate of partial cytogenetic response (PCyR).
10826095|NCT00101647|OG000|Outcome|Study Day 1|
10826096|NCT00101647|OG001|Outcome|Study Day 8|
10826097|NCT00101647|OG000|Outcome|Day 1|
10826098|NCT00101647|OG001|Outcome|Day 8|
10826099|NCT00101647|EG000|Reported Event|Intolerant|
10826100|NCT00101647|EG001|Reported Event|Resistant|
10826101|NCT00101660|BG000|Baseline|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
10826102|NCT00101660|BG001|Baseline|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
10826103|NCT00101660|BG002|Baseline|Total|Total of all reporting groups
10826104|NCT00101660|FG000|Participant Flow|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
10826105|NCT00101660|FG001|Participant Flow|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
10826106|NCT00101660|OG000|Outcome|Dasatinib, 70 mg, Twice Daily (BID)|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826107|NCT00101660|OG000|Outcome|Dastinib, 70 mg, BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826108|NCT00101660|OG000|Outcome|Dasatanib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826109|NCT00101660|OG000|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826110|NCT00101660|OG000|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826111|NCT00101660|OG000|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826112|NCT00101660|OG000|Outcome|Dasatinib,70 mg BID|"Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.~a"
10826113|NCT00101660|OG000|Outcome|Dasatinib|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
10826114|NCT00101660|EG000|Reported Event|Intolerant|
10826115|NCT00101660|EG001|Reported Event|Resistant|
10826116|NCT00101686|BG000|Baseline|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
10826117|NCT00101686|BG001|Baseline|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
10974201|NCT00929344|OG001|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974202|NCT00929344|OG002|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974203|NCT00929344|EG000|Reported Event|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974204|NCT00929344|EG001|Reported Event|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974205|NCT00929344|EG002|Reported Event|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
10974206|NCT00929357|BG000|Baseline|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
10974207|NCT00929357|BG001|Baseline|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
10974208|NCT00929357|BG002|Baseline|Total|Total of all reporting groups
10974209|NCT00929357|FG000|Participant Flow|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
10974210|NCT00929357|FG001|Participant Flow|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
10974211|NCT00929357|OG000|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
10974212|NCT00929357|OG001|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
10974213|NCT00929357|EG000|Reported Event|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
10974214|NCT00929357|EG001|Reported Event|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
10974215|NCT00929383|BG000|Baseline|Patients Treated With a Wingspan Stent|Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
10974216|NCT00929383|FG000|Participant Flow|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
10974217|NCT00929383|OG000|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
10974218|NCT00929383|EG000|Reported Event|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
10974219|NCT00929500|BG000|Baseline|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
10974220|NCT00929500|BG001|Baseline|Usual Care|Usual Care (UC) with Educational Lectures
10974221|NCT00929500|BG002|Baseline|Total|Total of all reporting groups
10974222|NCT00929500|FG000|Participant Flow|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
10974223|NCT00929500|FG001|Participant Flow|Usual Care|Usual Care (UC) with Educational Lectures
10974224|NCT00929500|OG000|Outcome|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
10974225|NCT00929500|OG001|Outcome|Usual Care|Usual Care (UC) with Educational Lectures
10974226|NCT00929500|EG000|Reported Event|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
10974227|NCT00929500|EG001|Reported Event|Usual Care|Usual Care (UC) with Educational Lectures
10974228|NCT00929526|BG000|Baseline|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
10974229|NCT00929526|BG001|Baseline|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
10974230|NCT00929526|BG002|Baseline|Total|Total of all reporting groups
10974231|NCT00929526|FG000|Participant Flow|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
10974232|NCT00929526|FG001|Participant Flow|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
10974233|NCT00929526|OG000|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
10974234|NCT00929526|OG001|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
10974235|NCT00929526|EG000|Reported Event|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
10974236|NCT00929526|EG001|Reported Event|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
10974237|NCT00929578|BG000|Baseline|All Study Participants - Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
10974238|NCT00929578|FG000|Participant Flow|All Study Participants|The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
10974239|NCT00929578|OG000|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
10974240|NCT00929578|OG001|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
10974241|NCT00929578|OG000|Outcome|All Study Participants|Participants who experienced at least one adverse event.
10974242|NCT00929578|OG000|Outcome|Baseline|Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
10974243|NCT00929578|OG001|Outcome|2 Hours Post Dose|Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
10974244|NCT00929578|OG002|Outcome|1 Week Post Dose|Participants with fluphenazine serum levels > 0.200ng/ml
10974245|NCT00929578|EG000|Reported Event|All Study Participants|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
10974246|NCT00929643|BG000|Baseline|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
10974247|NCT00929643|FG000|Participant Flow|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
10974248|NCT00929643|OG000|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
10974249|NCT00929643|EG000|Reported Event|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
10974250|NCT00929656|BG000|Baseline|Unimanual UE Training + Real rTMS|Participants randomized to the Experimental Arm received real rTMS (1000 pulses) to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
10974251|NCT00929656|BG001|Baseline|Unimanual UE Training + Sham rTMS|Participants randomized to the Placebo Arm received sham rTMS to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
10974252|NCT00929656|BG002|Baseline|Total|Total of all reporting groups
10974253|NCT00929656|FG000|Participant Flow|Unimanual UE Training + Real rTMS|"Unimanual Upper Extremity (UE) training + repetitive Transcranial Magnetic Stimulation (rTMS)~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
10974254|NCT00929656|FG001|Participant Flow|Unimanual UE Training + Sham rTMS|"Unimanual Upper Extremity (UE) training + sham repetitive Transcranial Magnetic Stimulation (rTMS)~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
10974255|NCT00929656|OG000|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
10974256|NCT00929656|OG001|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
10974257|NCT00929656|EG000|Reported Event|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
10826118|NCT00101686|BG002|Baseline|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
10826119|NCT00101686|BG003|Baseline|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
10826120|NCT00101686|BG004|Baseline|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
10826121|NCT00101686|BG005|Baseline|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
10826122|NCT00101686|BG006|Baseline|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
10826123|NCT00101686|BG007|Baseline|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
10826124|NCT00101686|BG008|Baseline|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
10826125|NCT00101686|BG009|Baseline|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
10826126|NCT00101686|BG010|Baseline|Total|Total of all reporting groups
10826127|NCT00101686|FG000|Participant Flow|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
10826128|NCT00101686|FG001|Participant Flow|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
10826129|NCT00101686|FG002|Participant Flow|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
10826130|NCT00101686|FG003|Participant Flow|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
10826131|NCT00101686|FG004|Participant Flow|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
10826132|NCT00101686|FG005|Participant Flow|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
10826133|NCT00101686|FG006|Participant Flow|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
10826134|NCT00101686|FG007|Participant Flow|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
10826135|NCT00101686|FG008|Participant Flow|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
10826136|NCT00101686|FG009|Participant Flow|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
10826137|NCT00101686|OG000|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
10826138|NCT00101686|OG001|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
10826139|NCT00101686|OG002|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
10826140|NCT00101686|OG000|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
10826141|NCT00101686|OG001|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
10826142|NCT00101686|OG000|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
10826143|NCT00101686|OG001|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
10826144|NCT00101686|OG001|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
10826145|NCT00101686|OG003|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
10826146|NCT00101686|OG004|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
10826147|NCT00101686|EG000|Reported Event|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
10826148|NCT00101686|EG001|Reported Event|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
10826149|NCT00101686|EG002|Reported Event|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
10826150|NCT00101686|EG003|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
10826151|NCT00101686|EG004|Reported Event|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
10826152|NCT00101816|BG000|Baseline|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
10826153|NCT00101816|BG001|Baseline|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
10826154|NCT00101816|BG002|Baseline|Total|Total of all reporting groups
10826155|NCT00101816|FG000|Participant Flow|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
10848550|NCT00290355|FG000|Participant Flow|GSK 249553 Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
10826156|NCT00101816|FG001|Participant Flow|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
10826157|NCT00101816|OG000|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
10826158|NCT00101816|OG001|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
10826159|NCT00101816|OG002|Outcome|Total|
10826160|NCT00101816|OG000|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
10826161|NCT00101816|OG000|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response
10826162|NCT00101816|OG001|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response (MaHR or MiHR).
10826163|NCT00101816|OG000|Outcome|MaHR|Participants acheiving MaHR, defined as best confirmed response of Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL) of Minore Hematologic Response (MiHR)
10826164|NCT00101816|OG001|Outcome|MCyR|Participants acheiving MCyR, defined as the rate of CCyR plus the rate of Partial Cytogenetic Response
10826165|NCT00101816|OG000|Outcome|Study Day 1|
10826166|NCT00101816|OG001|Outcome|Study Day 8|
10826167|NCT00101816|EG000|Reported Event|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
10826168|NCT00101816|EG001|Reported Event|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
10826169|NCT00101868|BG000|Baseline|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
10826170|NCT00101868|BG001|Baseline|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
10826171|NCT00101868|BG002|Baseline|Total|Total of all reporting groups
10826172|NCT00101868|FG000|Participant Flow|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
10848551|NCT00290355|FG001|Participant Flow|Placebo Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
10974258|NCT00929656|EG001|Reported Event|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
10974259|NCT00929669|BG000|Baseline|Pasireotide LAR|80 mg IM once monthly
10974260|NCT00929669|FG000|Participant Flow|Pasireotide LAR|80 mg IM once monthly
10974261|NCT00929669|OG000|Outcome|Pasireotide LAR|80 mg IM once monthly
10974262|NCT00929669|EG000|Reported Event|Pasireotide LAR|80 mg IM once monthly
10974263|NCT00929695|BG000|Baseline|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974264|NCT00929695|BG001|Baseline|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974265|NCT00929695|BG002|Baseline|Total|Total of all reporting groups
10974266|NCT00929695|FG000|Participant Flow|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974267|NCT00929695|FG001|Participant Flow|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974268|NCT00929695|OG000|Outcome|Grade IIa GVHD; 0.5 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
10974269|NCT00929695|OG001|Outcome|Grade IIa GVHD; 1.0 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
10974270|NCT00929695|OG002|Outcome|Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
10974271|NCT00929695|OG003|Outcome|Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
10974272|NCT00929695|OG000|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974273|NCT00929695|OG001|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
10974274|NCT00929695|OG001|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
10974275|NCT00929695|EG000|Reported Event|Arm I (Low-dose)|"Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
10974276|NCT00929695|EG001|Reported Event|Arm II (Standard-dose)|"Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
10974277|NCT00929708|BG000|Baseline|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974278|NCT00929708|BG001|Baseline|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974279|NCT00929708|BG002|Baseline|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974280|NCT00929708|BG003|Baseline|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
10974281|NCT00929708|BG004|Baseline|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
10974282|NCT00929708|BG005|Baseline|Total|Total of all reporting groups
10974283|NCT00929708|FG000|Participant Flow|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974284|NCT00929708|FG001|Participant Flow|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974285|NCT00929708|FG002|Participant Flow|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974286|NCT00929708|FG003|Participant Flow|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
10974287|NCT00929708|FG004|Participant Flow|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
10974288|NCT00929708|OG000|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974289|NCT00929708|OG001|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974290|NCT00929708|OG002|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974291|NCT00929708|OG003|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
10974292|NCT00929708|OG004|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
10974293|NCT00929708|EG000|Reported Event|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974294|NCT00929708|EG001|Reported Event|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974295|NCT00929708|EG002|Reported Event|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
10974296|NCT00929708|EG003|Reported Event|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
11312944|NCT03192488|FG001|Participant Flow|Placebo/Hypoxia, Placebo/Normoxia, Cetirizine/Hypoxia|"During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).~For the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft)."
11312945|NCT03192488|FG002|Participant Flow|Placebo/Normoxia, Cetirizine/Hypoxia, Placebo/Hypoxia|"During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).~For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft)."
11312946|NCT03192488|FG003|Participant Flow|Cetirizine/Hypoxia, Placebo/Normoxia, Placebo/Hypoxia|"During the first visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).~For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft)."
11312947|NCT03192488|FG004|Participant Flow|Placebo/Normoxia, Placebo/Hypoxia, Cetirizine/Hypoxia|"During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).~For the second visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~During the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft)."
11312948|NCT03192488|FG005|Participant Flow|Placebo/Hypoxia, Cetirizine/Hypoxia, Placebo/Normoxia|"During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen)."
11312949|NCT03192488|OG000|Outcome|Cetirizine and Hypoxia|"10 mg of Cetirizine given 60 min before exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Cetirizine: Cetirizine tablet 10 mg"
11312950|NCT03192488|OG001|Outcome|Placebo and Hypoxia|"Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: Gelatin placebo"
11312951|NCT03192488|OG002|Outcome|Placebo and Normoxia|"Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).~Placebo oral capsule: Gelatin placebo"
11312952|NCT03192488|OG000|Outcome|Cetirizine and Hypoxia (Baseline)|"10mg Cetirizine given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: 10 mg Cetirizine Histamine: assessed 60 min after pill ingestion, prior to exercise"
11312953|NCT03192488|OG001|Outcome|Cetirizine and Hypoxia (Post-Exercise)|"10mg Cetirizine given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: 10 mg Cetirizine Histamine: assessed 60 min after pill ingestion, 5-10 min after 8km time trial exercise"
11312954|NCT03192488|OG002|Outcome|Placebo and Hypoxia (Baseline)|"Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, prior to exercise"
11312955|NCT03192488|OG003|Outcome|Placebo and Hypoxia (Post-Exercise)|"Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 after 8km time trial exercise"
11312956|NCT03192488|OG004|Outcome|Placebo and Normoxia (Baseline)|"Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).~Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, prior to exercise"
11312957|NCT03192488|OG005|Outcome|Placebo and Normoxia (Post-Exercise)|"Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).~Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 min following 8km time trial exercise"
11312958|NCT03192488|EG000|Reported Event|Cetirizine and Hypoxia|"10 mg of Cetirizine given 60 min before exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Cetirizine: Cetirizine tablet 10 mg"
11312959|NCT03192488|EG001|Reported Event|Placebo and Hypoxia|"Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).~Placebo oral capsule: Gelatin placebo"
11312960|NCT03192488|EG002|Reported Event|Placebo and Normoxia|"Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).~Placebo oral capsule: Gelatin placebo"
11312961|NCT03192826|BG000|Baseline|Brinzolamide/Brimonidine FC|"1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy~Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy"
11312962|NCT03192826|BG001|Baseline|Brimonidine 0.2%|"1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy~Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy"
11312963|NCT03192826|BG002|Baseline|Artificial Tears|"1 drop of artificial tears 1 hour before Nd-YAG capsulotomy~Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy"
11312964|NCT03192826|BG003|Baseline|Total|Total of all reporting groups
11312965|NCT03192826|FG000|Participant Flow|Brinzolamide/Brimonidine FC|"1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy~Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy"
11312966|NCT03192826|FG001|Participant Flow|Brimonidine 0.2%|"1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy~Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy"
10974297|NCT00929708|EG004|Reported Event|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
10974298|NCT00929734|BG000|Baseline|Rosuvastatin|Rosuvastatin 10mg tablet
10974299|NCT00929734|BG001|Baseline|Placebo|Placebo tablet
10974300|NCT00929734|BG002|Baseline|Total|Total of all reporting groups
10974301|NCT00929734|FG000|Participant Flow|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
10974302|NCT00929734|FG001|Participant Flow|Placebo|Placebo: 1 tablet, once daily in three months
10974303|NCT00929734|OG000|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
10974304|NCT00929734|OG001|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
10974305|NCT00929734|EG000|Reported Event|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
10974306|NCT00929734|EG001|Reported Event|Placebo|Placebo: 1 tablet, once daily in three months
10974307|NCT00929773|BG000|Baseline|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
10974308|NCT00929773|BG001|Baseline|Placebo Laser|inactive light
10974309|NCT00929773|BG002|Baseline|Total|Total of all reporting groups
10974310|NCT00929773|FG000|Participant Flow|Erchonia PL2000 Laser|Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .
10974311|NCT00929773|FG001|Participant Flow|Placebo Laser|inactive light
10974312|NCT00929773|OG000|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
10974313|NCT00929773|OG001|Outcome|Placebo Laser|inactive light
10974314|NCT00929773|OG000|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
10974315|NCT00929773|EG000|Reported Event|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
10974316|NCT00929773|EG001|Reported Event|Placebo Laser|inactive light
10974317|NCT00929838|BG000|Baseline|Diabetes Knowledge/Information Arm|"Subjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.~Diabetes Knowledge/Information: This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks."
10974318|NCT00929838|BG001|Baseline|Motivation/Behavioral Skills Arm|"The motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).~Motivation/Behavioral Skills: This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks."
10974319|NCT00929838|BG002|Baseline|Combined Intervention Arm|"The combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.~Combined Intervention: This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks."
10974320|NCT00929838|BG003|Baseline|Usual Care Arm|"The usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.~Usual Care: This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content."
10974321|NCT00929838|BG004|Baseline|Total|Total of all reporting groups
10974322|NCT00929838|FG000|Participant Flow|Diabetes Knowledge/Information Arm|"Subjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.~Diabetes Knowledge/Information: This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks."
11312967|NCT03192826|FG002|Participant Flow|Artificial Tears|"1 drop of artificial tears 1 hour before Nd-YAG capsulotomy~Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy"
11312968|NCT03192826|OG000|Outcome|Brinzolamide/Brimonidine FC|"1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy~Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy"
11312969|NCT03192826|OG001|Outcome|Brimonidine 0.2%|"1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy~Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy"
10974323|NCT00929838|FG001|Participant Flow|Motivation/Behavioral Skills Arm|"The motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).~Motivation/Behavioral Skills: This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks."
10974324|NCT00929838|FG002|Participant Flow|Combined Intervention Arm|"The combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.~Combined Intervention: This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks."
10974325|NCT00929838|FG003|Participant Flow|Usual Care Arm|"The usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.~Usual Care: This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content."
10974326|NCT00929838|OG000|Outcome|Diabetes Knowledge/Information Arm|"Subjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.~Diabetes Knowledge/Information: This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks."
10974327|NCT00929838|OG001|Outcome|Motivation/Behavioral Skills Arm|"The motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).~Motivation/Behavioral Skills: This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks."
10974328|NCT00929838|OG002|Outcome|Combined Intervention Arm|"The combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.~Combined Intervention: This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks."
10974329|NCT00929838|OG003|Outcome|Usual Care Arm|"The usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.~Usual Care: This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content."
10974330|NCT00929838|EG000|Reported Event|Diabetes Knowledge/Information Arm|"Subjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.~Diabetes Knowledge/Information: This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks."
11312970|NCT03192826|OG002|Outcome|Artificial Tears|"1 drop of artificial tears 1 hour before Nd-YAG capsulotomy~Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy"
11312971|NCT03192826|EG000|Reported Event|Brinzolamide/Brimonidine FC|"1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy~Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy"
11312972|NCT03192826|EG001|Reported Event|Brimonidine 0.2%|"1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy~Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy"
10826173|NCT00101868|FG001|Participant Flow|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
10826174|NCT00101868|OG000|Outcome|Discharge Software|Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
10826175|NCT00101868|OG001|Outcome|Usual Care Discharge, Handwritten|The control intervention was the usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post-discharge activities and restrictions, post-discharge diet, post-discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, 1 page of which also included medication instructions and prescriptions.
10826176|NCT00101868|OG000|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
10826177|NCT00101868|OG001|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
10826178|NCT00101868|EG000|Reported Event|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
10826179|NCT00101868|EG001|Reported Event|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
10826180|NCT00101907|BG000|Baseline|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
10826181|NCT00101907|BG001|Baseline|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826182|NCT00101907|BG002|Baseline|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826183|NCT00101907|BG003|Baseline|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826184|NCT00101907|BG004|Baseline|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826185|NCT00101907|BG005|Baseline|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826186|NCT00101907|BG006|Baseline|Total|Total of all reporting groups
10826187|NCT00101907|FG000|Participant Flow|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
10826188|NCT00101907|FG001|Participant Flow|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826189|NCT00101907|FG002|Participant Flow|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826190|NCT00101907|FG003|Participant Flow|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826191|NCT00101907|FG004|Participant Flow|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10974331|NCT00929838|EG001|Reported Event|Motivation/Behavioral Skills Arm|"The motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).~Motivation/Behavioral Skills: This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks."
10974332|NCT00929838|EG002|Reported Event|Combined Intervention Arm|"The combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.~Combined Intervention: This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks."
10974333|NCT00929838|EG003|Reported Event|Usual Care Arm|"The usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.~Usual Care: This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content."
10974334|NCT00929864|BG000|Baseline|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
10974335|NCT00929864|BG001|Baseline|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
10974336|NCT00929864|BG002|Baseline|Total|Total of all reporting groups
10974337|NCT00929864|FG000|Participant Flow|125 mg Abatacept SC Weekly|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
10974338|NCT00929864|FG001|Participant Flow|40 mg Adalimumab SC Biweekly|Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
11312973|NCT03192826|EG002|Reported Event|Artificial Tears|"1 drop of artificial tears 1 hour before Nd-YAG capsulotomy~Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy"
10974339|NCT00929864|OG000|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
11312974|NCT03192904|BG000|Baseline|Energy Instruments Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure."
11312975|NCT03192904|BG001|Baseline|Stapling Device Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Stapling Device: Stapling Device, including linear stapler and curved stapler."
11312976|NCT03192904|BG002|Baseline|Total|Total of all reporting groups
11312977|NCT03192904|FG000|Participant Flow|Energy Instruments Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure."
10826192|NCT00101907|FG005|Participant Flow|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826193|NCT00101907|OG000|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
10826194|NCT00101907|OG001|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826195|NCT00101907|OG002|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826196|NCT00101907|OG003|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826197|NCT00101907|OG004|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826198|NCT00101907|OG005|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826199|NCT00101907|OG000|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826200|NCT00101907|OG001|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826201|NCT00101907|OG002|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826202|NCT00101907|OG003|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826203|NCT00101907|OG004|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826204|NCT00101907|OG001|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826205|NCT00101907|OG003|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826206|NCT00101907|EG000|Reported Event|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
10826207|NCT00101907|EG001|Reported Event|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826208|NCT00101907|EG002|Reported Event|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826209|NCT00101907|EG003|Reported Event|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826210|NCT00101907|EG004|Reported Event|125 mg QD AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826211|NCT00101907|EG005|Reported Event|75 mg BID AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
10826212|NCT00101933|BG000|Baseline|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
10826213|NCT00101933|BG001|Baseline|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
10826214|NCT00101933|BG002|Baseline|Total|Total of all reporting groups
10826215|NCT00101933|FG000|Participant Flow|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
10826216|NCT00101933|FG001|Participant Flow|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
10826217|NCT00101933|OG000|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
10826218|NCT00101933|OG001|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
10826219|NCT00101933|OG000|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
10826220|NCT00101933|EG000|Reported Event|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
10826221|NCT00101933|EG001|Reported Event|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
10974340|NCT00929864|OG001|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
10974341|NCT00929864|EG000|Reported Event|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
10974342|NCT00929864|EG001|Reported Event|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
11092684|NCT01541384|BG000|Baseline|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092685|NCT01541384|BG001|Baseline|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092686|NCT01541384|BG002|Baseline|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
11092687|NCT01541384|BG003|Baseline|Total|Total of all reporting groups
11092688|NCT01541384|FG000|Participant Flow|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092689|NCT01541384|FG001|Participant Flow|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092690|NCT01541384|FG002|Participant Flow|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
11092691|NCT01541384|OG000|Outcome|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11312978|NCT03192904|FG001|Participant Flow|Stapling Device Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Stapling Device: Stapling Device, including linear stapler and curved stapler."
10974343|NCT00929981|BG000|Baseline|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
10974344|NCT00929981|FG000|Participant Flow|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
10974345|NCT00929981|OG000|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
10974346|NCT00929981|EG000|Reported Event|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
10974347|NCT00929994|BG000|Baseline|Exercise|"Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974348|NCT00929994|FG000|Participant Flow|Exercise|"Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974349|NCT00929994|OG000|Outcome|Exercise|"Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974350|NCT00929994|OG000|Outcome|Exercise|"Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974351|NCT00929994|OG000|Outcome|Exercise|"Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program after a 12 week period of non intervention which will last 6 months and combine both resistance and aerobic training.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974352|NCT00929994|OG000|Outcome|Exercise|"Following a 3 month non intervention period, participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974353|NCT00929994|EG000|Reported Event|Exercise|"Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding cardiac rehabilitation.~Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training."
10974354|NCT00930046|BG000|Baseline|Ropivacaine Group|"Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery~Ropivacaine wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site."
10974355|NCT00930046|BG001|Baseline|Normal Saline Group|"Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.~Saline wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure"
10974356|NCT00930046|BG002|Baseline|Total|Total of all reporting groups
10974357|NCT00930046|FG000|Participant Flow|Ropivacaine Group|"Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery~Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site."
10974358|NCT00930046|FG001|Participant Flow|Normal Saline Group|"Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.~wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure"
10974359|NCT00930046|OG000|Outcome|Ropivacaine Group|"Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery~Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site."
10974360|NCT00930046|OG001|Outcome|Normal Saline Group|"Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.~wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure"
10974361|NCT00930046|EG000|Reported Event|Ropivacaine Group|"Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery~Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site."
10974362|NCT00930046|EG001|Reported Event|Normal Saline Group|"Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.~wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure"
10974363|NCT00930059|BG000|Baseline|Placebo|Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.
10974364|NCT00930059|BG001|Baseline|PF-04447943|PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
10974365|NCT00930059|BG002|Baseline|Total|Total of all reporting groups
10974366|NCT00930059|FG000|Participant Flow|Placebo|Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.
10974367|NCT00930059|FG001|Participant Flow|PF-04447943|PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
10974368|NCT00930059|OG000|Outcome|Placebo|Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.
10826222|NCT00102063|BG000|Baseline|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
10826223|NCT00102063|BG001|Baseline|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
10826224|NCT00102063|BG002|Baseline|Placebo Group|Participants were given a single pill administered once daily
10826225|NCT00102063|BG003|Baseline|Total|Total of all reporting groups
10826226|NCT00102063|FG000|Participant Flow|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
10826227|NCT00102063|FG001|Participant Flow|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
10826228|NCT00102063|FG002|Participant Flow|Placebo Group|Participants were given a single pill administered once daily
10826229|NCT00102063|OG000|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
10826230|NCT00102063|OG001|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
10826231|NCT00102063|OG002|Outcome|Placebo Group|Participants were given a single pill administered once daily
10826232|NCT00102063|EG000|Reported Event|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
10826233|NCT00102063|EG001|Reported Event|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
10826234|NCT00102063|EG002|Reported Event|Placebo Group|Participants were given a single pill administered once daily
10826235|NCT00102440|BG000|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
10826236|NCT00102440|BG001|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
10826237|NCT00102440|BG002|Baseline|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
10826238|NCT00102440|BG003|Baseline|Total|Total of all reporting groups
10826239|NCT00102440|FG000|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
10826240|NCT00102440|FG001|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
10826241|NCT00102440|FG002|Participant Flow|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
10826242|NCT00102440|OG000|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
10826243|NCT00102440|OG001|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
10826244|NCT00102440|OG002|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
10826245|NCT00102440|EG000|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
10826246|NCT00102440|EG001|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
10826247|NCT00102440|EG002|Reported Event|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
10826248|NCT00102518|BG000|Baseline|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
10826249|NCT00102518|FG000|Participant Flow|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
10826250|NCT00102518|OG000|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
10826251|NCT00102518|EG000|Reported Event|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
10826252|NCT00102531|BG000|Baseline|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
10826253|NCT00102531|BG001|Baseline|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
10826254|NCT00102531|BG002|Baseline|Total|Total of all reporting groups
10826255|NCT00102531|FG000|Participant Flow|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
10826256|NCT00102531|FG001|Participant Flow|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
10826257|NCT00102531|OG000|Outcome|Cisplatin Liposomal 24 mg/m2|Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation
10826258|NCT00102531|OG001|Outcome|Cisplatin Liposomal 36 mg/m2|The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
10826259|NCT00102531|EG000|Reported Event|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
10974369|NCT00930059|OG001|Outcome|PF-04447943|PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
10974370|NCT00930059|EG000|Reported Event|Placebo|Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.
10974371|NCT00930059|EG001|Reported Event|PF-04447943|PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
10974372|NCT00930176|BG000|Baseline|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
10974373|NCT00930176|FG000|Participant Flow|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
10974374|NCT00930176|OG000|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
10974375|NCT00930176|EG000|Reported Event|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
10974376|NCT00930293|BG000|Baseline|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974377|NCT00930293|BG001|Baseline|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974378|NCT00930293|BG002|Baseline|Total|Total of all reporting groups
10974379|NCT00930293|FG000|Participant Flow|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974380|NCT00930293|FG001|Participant Flow|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974381|NCT00930293|OG000|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974382|NCT00930293|OG001|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974383|NCT00930293|EG000|Reported Event|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974384|NCT00930293|EG001|Reported Event|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
10974385|NCT00930553|BG000|Baseline|Alemtuzumab|Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.
10974386|NCT00930553|FG000|Participant Flow|Alemtuzumab|Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.
10974387|NCT00930553|OG000|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study (CAMMS03409).
10974388|NCT00930553|OG001|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study (CAMMS03409).
10974389|NCT00930553|OG000|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
10974390|NCT00930553|OG001|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974391|NCT00930553|OG002|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
10974392|NCT00930553|OG003|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974393|NCT00930553|OG000|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 (NCT00530348) or CAMMS324 (NCT00548405), received an additional course of alemtuzumab in this study.
10974394|NCT00930553|OG000|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
10974395|NCT00930553|OG001|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
10974396|NCT00930553|OG000|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
10974397|NCT00930553|OG001|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974398|NCT00930553|OG002|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
10974399|NCT00930553|OG003|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974400|NCT00930553|OG000|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974401|NCT00930553|OG001|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
10974402|NCT00930553|OG000|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
10974403|NCT00930553|OG001|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
10974404|NCT00930553|OG000|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
10974405|NCT00930553|OG000|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
10974406|NCT00930553|EG000|Reported Event|Alemtuzumab|Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
10974407|NCT00930644|BG000|Baseline|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
10974408|NCT00930644|FG000|Participant Flow|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
10974409|NCT00930644|OG000|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
10974410|NCT00930644|OG001|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
10974411|NCT00930644|OG002|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
10974412|NCT00930644|EG000|Reported Event|NT,PBO/TED|No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
10974413|NCT00930644|EG001|Reported Event|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
10974414|NCT00930761|BG000|Baseline|Control|
10974415|NCT00930761|BG001|Baseline|Music Therapy|
10974416|NCT00930761|BG002|Baseline|Total|Total of all reporting groups
10974417|NCT00930761|FG000|Participant Flow|Control|
10974418|NCT00930761|FG001|Participant Flow|Music Therapy|
10974419|NCT00930761|OG000|Outcome|Control|
10974420|NCT00930761|OG001|Outcome|Music Therapy|
10974421|NCT00930761|EG000|Reported Event|Control|
10974422|NCT00930761|EG001|Reported Event|Music Therapy|
10974423|NCT00930774|BG000|Baseline|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
10974424|NCT00930774|BG001|Baseline|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
10974425|NCT00930774|BG002|Baseline|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
10974426|NCT00930774|BG003|Baseline|Standard-of-Care|Standard-of-care informational counseling
10974427|NCT00930774|BG004|Baseline|Total|Total of all reporting groups
10974428|NCT00930774|FG000|Participant Flow|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
10974429|NCT00930774|FG001|Participant Flow|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
10974430|NCT00930774|FG002|Participant Flow|FM System and Auditory Training|"Provision of frequency modulation (FM) assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
11312979|NCT03192904|OG000|Outcome|Energy Instruments Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure."
11312980|NCT03192904|OG001|Outcome|Stapling Device Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Stapling Device: Stapling Device, including linear stapler and curved stapler."
11312981|NCT03192904|EG000|Reported Event|Energy Instruments Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure."
10826260|NCT00102531|EG001|Reported Event|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
10826261|NCT00102596|BG000|Baseline|All Participants|Baseline is included for all participants who passed screening and received at least 1 dose of 1-octanol, whether in Part A, B or C
10826262|NCT00102596|FG000|Participant Flow|Part A: Dose Escalation|"Subjects fasted overnight for 6 hours and received 1, 4, 8, 16, 32 and 64 mg/kg 1-octanol at 6AM on different days. There were 2 formulations:~1) 2 participants received 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; and 2) two participants received a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA)."
10826263|NCT00102596|FG001|Participant Flow|Part B Then C: Fixed Dose|"In Part B, subjects fasted overnight for 6 hours and received 64 mg/kg 1-octanol at 6AM of both formulations:~1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).~At the completion of Parts A and B, an exploratory Part C was added in which subjects fasted overnight for 6 hours and received 128 mg/kg 1-octanol at 6AM of both formulations."
10826264|NCT00102596|OG000|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
10826265|NCT00102596|OG001|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
10826266|NCT00102596|OG000|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of the 1-octanol
10826267|NCT00102596|OG000|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
10826268|NCT00102596|EG000|Reported Event|1-octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
10826269|NCT00102687|BG000|Baseline|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
10826270|NCT00102687|BG001|Baseline|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
10826271|NCT00102687|BG002|Baseline|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
10826272|NCT00102687|BG003|Baseline|Total|Total of all reporting groups
10826273|NCT00102687|FG000|Participant Flow|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
10826274|NCT00102687|FG001|Participant Flow|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
10826275|NCT00102687|FG002|Participant Flow|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
10826276|NCT00102687|FG003|Participant Flow|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
10826277|NCT00102687|FG004|Participant Flow|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
10826278|NCT00102687|OG000|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
10826279|NCT00102687|OG001|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
10826280|NCT00102687|OG002|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
10826281|NCT00102687|OG000|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
10826282|NCT00102687|OG001|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
10826283|NCT00102687|OG002|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
10826284|NCT00102687|OG000|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
10826285|NCT00102687|OG001|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
10826286|NCT00102687|OG002|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.
10826287|NCT00102687|EG000|Reported Event|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
10826288|NCT00102687|EG001|Reported Event|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
10826289|NCT00102687|EG002|Reported Event|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
10826290|NCT00102687|EG003|Reported Event|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
10826291|NCT00102687|EG004|Reported Event|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
10826292|NCT00102804|BG000|Baseline|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826293|NCT00102804|BG001|Baseline|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826294|NCT00102804|BG002|Baseline|Total|Total of all reporting groups
10826295|NCT00102804|FG000|Participant Flow|Pemetrexed and BSC|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.~Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826296|NCT00102804|FG001|Participant Flow|Placebo and BSC|"Placebo: IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826297|NCT00102804|OG000|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826298|NCT00102804|OG001|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826299|NCT00102804|EG000|Reported Event|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826300|NCT00102804|EG001|Reported Event|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
10826301|NCT00102960|BG000|Baseline|Deferred Therapy|"For participants with a CD4% of at least 25%, ART deferred until necessary. Once ART therapy was initiated, it was taken continously.~Zidovudine: First Line Regimen: Given twice daily at a dose of 240 mg/m^2 of body surface area. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826302|NCT00102960|BG001|Baseline|Early Therapy up to 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826303|NCT00102960|BG002|Baseline|Early Therapy up to 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826304|NCT00102960|BG003|Baseline|Total|Total of all reporting groups
10974431|NCT00930774|FG003|Participant Flow|Standard-of-Care|Standard-of-care informational counseling
10974432|NCT00930774|OG000|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
10974433|NCT00930774|OG001|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
10974434|NCT00930774|OG002|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
10974435|NCT00930774|OG003|Outcome|Standard-of-care|Standard-of-care informational counseling
10974436|NCT00930774|OG002|Outcome|FM Sytem + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
10974437|NCT00930774|EG000|Reported Event|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
10974438|NCT00930774|EG001|Reported Event|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
10974439|NCT00930774|EG002|Reported Event|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
10974440|NCT00930774|EG003|Reported Event|Standard-of-care|Standard-of-care informational counseling
10974441|NCT00930813|BG000|Baseline|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
10974442|NCT00930813|BG001|Baseline|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
10974443|NCT00930813|BG002|Baseline|Total|Total of all reporting groups
10974444|NCT00930813|FG000|Participant Flow|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
10974445|NCT00930813|FG001|Participant Flow|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
10974446|NCT00930813|OG000|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel Coated Balloon Catheter
10974447|NCT00930813|OG001|Outcome|Standard Uncoated PTA Catheter|Standard off-the-shelf uncoated PTA Catheter
10974448|NCT00930813|OG000|Outcome|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
10974449|NCT00930813|OG001|Outcome|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
10974450|NCT00930813|EG000|Reported Event|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
10974451|NCT00930813|EG001|Reported Event|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
10974452|NCT00930930|BG000|Baseline|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974453|NCT00930930|BG001|Baseline|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974454|NCT00930930|BG002|Baseline|Total|Total of all reporting groups
10974455|NCT00930930|FG000|Participant Flow|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974456|NCT00930930|FG001|Participant Flow|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974457|NCT00930930|OG000|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974458|NCT00930930|OG001|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974459|NCT00930930|EG000|Reported Event|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10826305|NCT00102960|FG000|Participant Flow|ART-Deferred|"For participants with a CD4% of at least 25%, ART deferred until necessary. Once ART therapy was initiated, it was taken continously.~Zidovudine: First Line Regimen: Given twice daily at a dose of 240 mg/m^2 of body surface area. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826306|NCT00102960|FG001|Participant Flow|Early ART up to 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826307|NCT00102960|FG002|Participant Flow|Early ART up to 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826308|NCT00102960|OG000|Outcome|Deferred Therapy|"For participants with a CD4% of at least 25%, ART deferred until necessary. Once ART therapy was initiated, it was taken continuously.~Zidovudine: First Line Regimen: Given twice daily at a dose of 240 mg/m^2 of body surface area. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826309|NCT00102960|OG001|Outcome|Early Therapy up to 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826310|NCT00102960|OG002|Outcome|Early Therapy up to 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826311|NCT00102960|OG001|Outcome|Early ART for 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10848552|NCT00290355|OG000|Outcome|GSK 249553 Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
11312982|NCT03192904|EG001|Reported Event|Stapling Device Group|"All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.~Stapling Device: Stapling Device, including linear stapler and curved stapler."
11312983|NCT03193021|BG000|Baseline|Cardiva Mid-Bore VVCS|"Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.~Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient."
11312984|NCT03193021|BG001|Baseline|Manual Compression|"Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.~Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient."
11312985|NCT03193021|BG002|Baseline|Total|Total of all reporting groups
11312986|NCT03193021|FG000|Participant Flow|Cardiva Mid-Bore VVCS|"Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.~Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient."
11312987|NCT03193021|FG001|Participant Flow|Manual Compression|"Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.~Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient."
11312988|NCT03193021|OG000|Outcome|Cardiva Mid-Bore VVCS|"Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.~Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient."
11312989|NCT03193021|OG001|Outcome|Manual Compression|"Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.~Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient."
11312990|NCT03193021|EG000|Reported Event|Cardiva Mid-Bore VVCS|"Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.~Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient."
11312991|NCT03193021|EG001|Reported Event|Manual Compression|"Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.~Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient."
11312992|NCT03193047|BG000|Baseline|Placebo Plus Evolocumab|Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
11312993|NCT03193047|BG001|Baseline|Bempedoic Acid Plus Evolocumab|Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
11312994|NCT03193047|BG002|Baseline|Total|Total of all reporting groups
11312995|NCT03193047|FG000|Participant Flow|Placebo Plus Evolocumab|Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
11312996|NCT03193047|FG001|Participant Flow|Bempedoic Acid Plus Evolocumab|Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected once a month over 9 minutes as background therapy.
11312997|NCT03193047|OG000|Outcome|Placebo Plus Evolocumab|Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
11312998|NCT03193047|OG001|Outcome|Bempedoic Acid Plus Evolocumab|Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
11312999|NCT03193047|OG000|Outcome|Placebo + Evolocumab|Participants received matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
11313000|NCT03193047|OG001|Outcome|Bempedoic Acid + Evolocumab|Participants received oral bempedoic acid 180 mg tablet once a day (with or without food), plus evolocumab 420 mg injected once a month over 9 minutes as background therapy.
11313001|NCT03193047|EG000|Reported Event|Placebo Plus Evolocumab|Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
11313002|NCT03193047|EG001|Reported Event|Bempedoic Acid Plus Evolocumab|Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
11313003|NCT03193398|BG000|Baseline|BTRX-246040|"40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.~BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks"
11313004|NCT03193398|BG001|Baseline|Placebo|"administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.~Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks"
11313005|NCT03193398|BG002|Baseline|Total|Total of all reporting groups
11313006|NCT03193398|FG000|Participant Flow|BTRX-246040|"40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.~BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks"
11313007|NCT03193398|FG001|Participant Flow|Placebo|"administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.~Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks"
11313008|NCT03193398|OG000|Outcome|BTRX-246040|"40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.~BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks"
10974460|NCT00930930|EG001|Reported Event|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
10974461|NCT00930969|BG000|Baseline|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
10974462|NCT00930969|FG000|Participant Flow|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
10974463|NCT00930969|OG000|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
10974464|NCT00930969|EG000|Reported Event|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
10974465|NCT00930982|BG000|Baseline|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
10974466|NCT00930982|BG001|Baseline|Placebo|Inhalation of matching placebo twice a day
10974467|NCT00930982|BG002|Baseline|Total|Total of all reporting groups
10974468|NCT00930982|FG000|Participant Flow|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
10974469|NCT00930982|FG001|Participant Flow|Placebo|Inhalation of matching placebo twice a day
10974470|NCT00930982|OG000|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
10974471|NCT00930982|OG001|Outcome|Placebo|Inhalation of matching placebo twice a day
10974472|NCT00930982|EG000|Reported Event|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
10974473|NCT00930982|EG001|Reported Event|Placebo|Inhalation of matching placebo twice a day
10974474|NCT00931164|BG000|Baseline|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
10974475|NCT00931164|FG000|Participant Flow|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
10974476|NCT00931164|OG000|Outcome|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
10974477|NCT00931164|EG000|Reported Event|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
10974478|NCT00931242|BG000|Baseline|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
10974479|NCT00931242|BG001|Baseline|Screen Failures|Subjects that were screened but failed to meet inclusion criteria for the study.
10974480|NCT00931242|BG002|Baseline|Total|Total of all reporting groups
10974481|NCT00931242|FG000|Participant Flow|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
10974482|NCT00931242|FG001|Participant Flow|Screen Failures|Patients who were screened but failed to meet inclusion criteria for the study
10974483|NCT00931242|OG000|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
10974484|NCT00931242|EG000|Reported Event|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
10974485|NCT00931268|BG000|Baseline|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
10974486|NCT00931268|FG000|Participant Flow|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
10974487|NCT00931268|OG000|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
10974488|NCT00931268|EG000|Reported Event|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
10974489|NCT00931307|BG000|Baseline|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
10974490|NCT00931307|FG000|Participant Flow|Lotrafilcon A|Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
10974491|NCT00931307|OG000|Outcome|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
10974492|NCT00931307|EG000|Reported Event|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
10974493|NCT00931359|BG000|Baseline|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
10974494|NCT00931359|BG001|Baseline|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
10974495|NCT00931359|BG002|Baseline|Total|Total of all reporting groups
10974496|NCT00931359|FG000|Participant Flow|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
10974497|NCT00931359|FG001|Participant Flow|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
10974498|NCT00931359|OG000|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
10974499|NCT00931359|OG001|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
10974500|NCT00931359|EG000|Reported Event|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
10974501|NCT00931359|EG001|Reported Event|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
10974502|NCT00931385|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
10974503|NCT00931385|FG000|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974504|NCT00931385|FG001|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974505|NCT00931385|FG002|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
11313009|NCT03193398|OG001|Outcome|Placebo|"administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.~Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks"
11313010|NCT03193398|EG000|Reported Event|BTRX-246040|"40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.~BTRX-246040 oral capsule(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks"
10974506|NCT00931385|FG003|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974507|NCT00931385|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
10974508|NCT00931385|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974509|NCT00931385|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974510|NCT00931385|OG003|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974511|NCT00931385|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974512|NCT00931385|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974513|NCT00931385|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974514|NCT00931385|OG003|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974515|NCT00931385|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974516|NCT00931385|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974517|NCT00931385|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
11313011|NCT03193398|EG001|Reported Event|Placebo|"administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.~Placebo oral capsule(s): administered once daily to patients with MDD for 8 weeks"
11313012|NCT03193593|BG000|Baseline|Placebo Injections|Placebo Injection into the Pectoralis Muscle
10974518|NCT00931385|EG003|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974519|NCT00931411|BG000|Baseline|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
10974520|NCT00931411|BG001|Baseline|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
10974521|NCT00931411|BG002|Baseline|Total|Total of all reporting groups
11313013|NCT03193593|BG001|Baseline|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Single Injection of active drug into the pectoralis muscle"
11313014|NCT03193593|BG002|Baseline|EB-001 Dose 2 (1.6X)|"2nd Dose in escalation paradigm, 1.6X Dose 1.~Single Injection of active drug into the pectoralis muscle."
11313015|NCT03193593|BG003|Baseline|EB-001 Dose 3 (3.3X)|"3rd Dose in escalation paradigm, 3.3X Dose 1.~Single Injection of active drug into the pectoralis muscle."
11313016|NCT03193593|BG004|Baseline|EB-001 Dose 4 (6.7X)|"4th Dose in escalation paradigm, 6.7X Dose 1.~Single Injection of active drug into the pectoralis muscle."
10826312|NCT00102960|OG002|Outcome|Early Therapy for 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily"
10826313|NCT00102960|OG001|Outcome|Early Therapy 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826314|NCT00102960|OG002|Outcome|Early Therapy 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826315|NCT00102960|EG000|Reported Event|ART-Deferred|"For participants with a CD4% of at least 25%, ART deferred until necessary. Once ART therapy was initiated, it was taken continuously.~Zidovudine: First Line Regimen: Given twice daily at a dose of 240 mg/m^2 of body surface area. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826316|NCT00102960|EG001|Reported Event|Early ART up to 40 Weeks|"For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826317|NCT00102960|EG002|Reported Event|Early ART up to 96 Weeks|"For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday~Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older.~Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily~Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight.~Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m^2~Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.~Didanosine: Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age.~Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight.~Nevirapine: Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily."
10826318|NCT00103012|BG000|Baseline|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
10826319|NCT00103012|BG001|Baseline|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
10826320|NCT00103012|BG002|Baseline|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
10826321|NCT00103012|BG003|Baseline|Total|Total of all reporting groups
10826322|NCT00103012|FG000|Participant Flow|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
10826323|NCT00103012|FG001|Participant Flow|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
10974522|NCT00931411|FG000|Participant Flow|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
10974523|NCT00931411|FG001|Participant Flow|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
10974524|NCT00931411|OG000|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
10974525|NCT00931411|OG001|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
10974526|NCT00931411|OG000|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
10974527|NCT00931411|OG001|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
10974528|NCT00931411|OG000|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
10974529|NCT00931411|OG000|Outcome|All Study Patients|
11313017|NCT03193593|BG005|Baseline|EB-001 Dose 5 (10X)|"5th Dose in escalation paradigm, 10X Dose 1.~Single Injection of active drug into the pectoralis muscle."
10974530|NCT00931411|EG000|Reported Event|Formulation 609580 20|"Adverse events that were recorded before Day 42 for the group Formulation 609580 20 then 609209 and recorded in the subsequent 2 weeks for the group Formulation 609209 then 609580 20. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
10974531|NCT00931411|EG001|Reported Event|Formulation 609209|"Adverse events that were recorded before Day 42 for the group Formulation 609209 then 609580 20 and recorded in the subsequent 2 weeks for the group Formulation 609580 20 then 609209. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
10974532|NCT00931463|BG000|Baseline|Ritonavir-boosted Lopinavir and 2N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
10974533|NCT00931463|BG001|Baseline|Ritonavir-boosted Lopinavir and Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
10974534|NCT00931463|BG002|Baseline|Total|Total of all reporting groups
10974535|NCT00931463|FG000|Participant Flow|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
10974536|NCT00931463|FG001|Participant Flow|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
10974537|NCT00931463|OG000|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
10974538|NCT00931463|OG001|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
10974539|NCT00931463|EG000|Reported Event|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
10974540|NCT00931463|EG001|Reported Event|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
10974541|NCT00931489|BG000|Baseline|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974542|NCT00931489|BG001|Baseline|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974543|NCT00931489|BG002|Baseline|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974544|NCT00931489|BG003|Baseline|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974545|NCT00931489|BG004|Baseline|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974546|NCT00931489|BG005|Baseline|Total|Total of all reporting groups
11313018|NCT03193593|BG006|Baseline|EB-001 Dose 6 (13.3X)|"6th Dose in escalation paradigm, 13.3X Dose 1.~Single Injection of active drug into the pectoralis muscle."
11313019|NCT03193593|BG007|Baseline|Total|Total of all reporting groups
11313020|NCT03193593|FG000|Participant Flow|Placebo Injections|Placebo Injection into the Pectoralis Muscle
11313021|NCT03193593|FG001|Participant Flow|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Injection of active drug into the pectoralis muscle"
10974547|NCT00931489|FG000|Participant Flow|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974548|NCT00931489|FG001|Participant Flow|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974549|NCT00931489|FG002|Participant Flow|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974550|NCT00931489|FG003|Participant Flow|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974551|NCT00931489|FG004|Participant Flow|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974552|NCT00931489|OG000|Outcome|"Neovascular Wet Age-related Macular Degeneration Patients"|"Subjects with active neovascular (wet) AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic non-responders - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.~At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3."
10974553|NCT00931489|OG001|Outcome|Population Normals|Normals are subjects that do not have Age-related Macular Degeneration. Group 2
10974554|NCT00931489|OG000|Outcome|"Neovascular Wet AMD Patients - Responders"|"Subjects with neovascular (wet) Age-related Macular Degeneration who respond to ranibizumab after 4 consecutive intraocular injections Group 1"
10974555|NCT00931489|OG001|Outcome|"Neovascular Wet AMD Patients - Acute Non-responders"|"Subjects with neovascular (wet) AMD treated with 4 or more monthly injections of anti-VEGF without an adequate response (persistent fluid on OCT) Group 3 - non-responders"
10974556|NCT00931489|EG000|Reported Event|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974557|NCT00931489|EG001|Reported Event|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974558|NCT00931489|EG002|Reported Event|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974559|NCT00931489|EG003|Reported Event|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
10974560|NCT00931489|EG004|Reported Event|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
10974561|NCT00931515|BG000|Baseline|NuBac|The NUBAC® disc arthroplasty system.
10974562|NCT00931515|BG001|Baseline|ProDisc|The ProDisc® total disc replacement system.
10974563|NCT00931515|BG002|Baseline|Total|Total of all reporting groups
10974564|NCT00931515|FG000|Participant Flow|NuBac|The NUBAC® disc arthroplasty system.
10974565|NCT00931515|FG001|Participant Flow|ProDisc|The ProDisc® total disc replacement system.
10974566|NCT00931515|OG000|Outcome|NuBac|The NUBAC® disc arthroplasty system.
10974567|NCT00931515|OG001|Outcome|ProDisc|The ProDisc® device total disc replacement system.
10974568|NCT00931515|EG000|Reported Event|NuBac|The NUBAC® disc arthroplasty system.
10974569|NCT00931515|EG001|Reported Event|ProDisc|The ProDisc® device total disc replacement system.
10974570|NCT00931528|BG000|Baseline|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
10974571|NCT00931528|BG001|Baseline|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
10974572|NCT00931528|BG002|Baseline|Total|Total of all reporting groups
10974573|NCT00931528|FG000|Participant Flow|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
10974574|NCT00931528|FG001|Participant Flow|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
10974575|NCT00931528|OG000|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
10974576|NCT00931528|OG001|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
10974577|NCT00931528|OG000|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
10974578|NCT00931528|EG000|Reported Event|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
10974579|NCT00931528|EG001|Reported Event|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
10974580|NCT00931632|BG000|Baseline|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
10974581|NCT00931632|BG001|Baseline|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
10974582|NCT00931632|BG002|Baseline|Total|Total of all reporting groups
10974583|NCT00931632|FG000|Participant Flow|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
10974584|NCT00931632|FG001|Participant Flow|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
10974585|NCT00931632|OG000|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
10974586|NCT00931632|OG001|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
10974587|NCT00931632|EG000|Reported Event|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
10974588|NCT00931632|EG001|Reported Event|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
10974589|NCT00931710|BG000|Baseline|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
10974590|NCT00931710|BG001|Baseline|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
10974591|NCT00931710|BG002|Baseline|Total|Total of all reporting groups
10974592|NCT00931710|FG000|Participant Flow|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
10974593|NCT00931710|FG001|Participant Flow|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
10974594|NCT00931710|OG000|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
10974595|NCT00931710|OG001|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
10974596|NCT00931710|EG000|Reported Event|Valsartan / Amlodipine / HCTZ|Valsartan / amlodipine / HCTZ
10974597|NCT00931710|EG001|Reported Event|Losartan / HCTZ|Losartan / HCTZ
10974598|NCT00931723|BG000|Baseline|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
10974599|NCT00931723|BG001|Baseline|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
10974600|NCT00931723|BG002|Baseline|Total|Total of all reporting groups
10974601|NCT00931723|FG000|Participant Flow|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
10974602|NCT00931723|FG001|Participant Flow|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
10974603|NCT00931723|OG000|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
10974604|NCT00931723|OG001|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
10974605|NCT00931723|EG000|Reported Event|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
10974606|NCT00931723|EG001|Reported Event|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
10974607|NCT00931762|BG000|Baseline|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
10974608|NCT00931762|FG000|Participant Flow|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
10974609|NCT00931762|OG000|Outcome|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
10974610|NCT00931762|EG000|Reported Event|Panobinostat|Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
10974611|NCT00931801|BG000|Baseline|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
10974612|NCT00931801|BG001|Baseline|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
10826324|NCT00103012|FG002|Participant Flow|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
10826325|NCT00103012|OG000|Outcome|Influence of Ginkgo Biloba on Lopinavir Disposition|Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
10826326|NCT00103012|OG001|Outcome|Influence of Echinacea on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
10826327|NCT00103012|OG002|Outcome|Influence of Panax Ginseng on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
10826328|NCT00103012|EG000|Reported Event|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
10826329|NCT00103012|EG001|Reported Event|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
10826330|NCT00103012|EG002|Reported Event|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
10826331|NCT00103116|BG000|Baseline|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
10826332|NCT00103116|FG000|Participant Flow|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
10826333|NCT00103116|OG000|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
10826334|NCT00103116|EG000|Reported Event|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
10826335|NCT00103142|BG000|Baseline|Experimental PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
10826336|NCT00103142|BG001|Baseline|Experimental PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
10826337|NCT00103142|BG002|Baseline|Total|Total of all reporting groups
10826338|NCT00103142|FG000|Participant Flow|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
10826339|NCT00103142|FG001|Participant Flow|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
10974613|NCT00931801|BG002|Baseline|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
10826340|NCT00103142|OG000|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
10826341|NCT00103142|OG001|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
10826342|NCT00103142|OG000|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
10826343|NCT00103142|OG001|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
10826344|NCT00103142|EG000|Reported Event|Arm I|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
10826345|NCT00103142|EG001|Reported Event|Arm II|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
10974614|NCT00931801|BG003|Baseline|Total|Total of all reporting groups
10974615|NCT00931801|FG000|Participant Flow|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
10974616|NCT00931801|FG001|Participant Flow|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
10974617|NCT00931801|FG002|Participant Flow|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
10974618|NCT00931801|OG000|Outcome|Control Arm|Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
10974619|NCT00931801|OG001|Outcome|Intervention Arm No.1|switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
10974620|NCT00931801|OG002|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
10974621|NCT00931801|OG000|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
10974622|NCT00931801|OG001|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
10974623|NCT00931801|OG003|Outcome|Total|All study arms combined
10974624|NCT00931801|EG000|Reported Event|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
10974625|NCT00931801|EG001|Reported Event|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
10974626|NCT00931801|EG002|Reported Event|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
10974627|NCT00931801|EG003|Reported Event|Total|All study arms combined
10974628|NCT00931879|BG000|Baseline|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
10974629|NCT00931879|BG001|Baseline|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
10974630|NCT00931879|BG002|Baseline|Total|Total of all reporting groups
10974631|NCT00931879|FG000|Participant Flow|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
10974632|NCT00931879|FG001|Participant Flow|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
10974633|NCT00931879|OG000|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
10974634|NCT00931879|OG001|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
10974635|NCT00931879|OG001|Outcome|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
10974636|NCT00931879|EG000|Reported Event|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
10974637|NCT00931879|EG001|Reported Event|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
10974638|NCT00931892|BG000|Baseline|Low Gluten Group|"Participants meeting inclusion criteria were randomized into the low gluten group. These participants ate two slices of wheat bread per day (3 g of gluten). Bread was procured from a standard source and gluten dose tested using the RIDASCREEN Gliadin R5 antibody ELISA. The study included a 14-day run-in period followed by a 14 day gluten challenge and a final visit 14 days post-gluten challenge. Other than the dispensed bread, subjects were instructed to remain on their gluten-free diet throughout the duration of the study.~Gluten: 3g"
10974639|NCT00931892|BG001|Baseline|High Gluten Group|"Participants meeting inclusion criteria were randomized into the low gluten group. These participants ate five slices of wheat bread per day (10 g of gluten). Bread was procured from a standard source and gluten dose tested using the RIDASCREEN Gliadin R5 antibody ELISA. The study included a 14-day run-in period followed by a 14 day gluten challenge and a final visit 14 days post-gluten challenge. Other than the dispensed bread, subjects were instructed to remain on their gluten-free diet throughout the duration of the study.~Gluten: 10g"
10974640|NCT00931892|BG002|Baseline|Total|Total of all reporting groups
10974641|NCT00931892|FG000|Participant Flow|Low Gluten Group|"Subjects will eat 3g of gluten per day~Gluten: 3g"
10974642|NCT00931892|FG001|Participant Flow|High Gluten Group|"Subjects will eat 10g of gluten per day~Gluten: 10g"
10974643|NCT00931892|OG000|Outcome|Baseline (Day -14) Low Gluten Group|"Villous height to crypt depth ratio in low gluten group~In the low gluten group, subjects consumed 3 grams of gluten per day"
10974644|NCT00931892|OG001|Outcome|Baseline (Day -14) High Gluten Group|"Villous height to crypt depth ratio in high gluten group~In the high gluten group, subjects consumed 10 grams of gluten per day."
10974645|NCT00931892|OG002|Outcome|Day 3 Low Gluten Group|"Villous height to crypt depth ratio in low gluten group~In the low gluten group, subjects consumed 3 grams of gluten per day."
10974646|NCT00931892|OG003|Outcome|Day 3 High Gluten Group|"Villous height to crypt depth ratio in high gluten group~In the high gluten group, subjects consumed 10 grams of gluten per day."
10974647|NCT00931892|OG004|Outcome|Day 14 Low Gluten Group|"Villous height to crypt depth ratio in low gluten group~In the low gluten group, subjects consumed 3 grams of gluten per day"
10974648|NCT00931892|OG005|Outcome|Day 14 High Gluten Group|"Villous height to crypt depth ratio in high gluten group.~In the high gluten group subjects consume 10 grams of gluten per day."
10974649|NCT00931892|OG000|Outcome|Baseline (Day -14) Low Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in low gluten dose groups.~Subjects in the low gluten dose group consumed 3 grams of gluten per day."
10974650|NCT00931892|OG001|Outcome|Baseline (Day -14) High Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in high gluten dose groups.~Subjects in the high gluten dose group consumed 10 grams of gluten per day"
10974651|NCT00931892|OG002|Outcome|Day 3 Low Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in low gluten dose groups.~Subjects in the low gluten dose group consumed 3 grams of gluten per day"
10974652|NCT00931892|OG003|Outcome|Day 3 High Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in high gluten dose groups.~Subjects in the low gluten dose group consumed 10 grams of gluten per day"
10974653|NCT00931892|OG004|Outcome|Day 14 Low Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in low gluten dose groups.~Subjects in the low gluten dose group consumed 3 grams of gluten per day"
10974654|NCT00931892|OG005|Outcome|Day 14 High Gluten Dose Group|"Intraepithelial lymphocyte count(per 100 enterocytes) in high gluten dose groups.~Subjects in the high gluten dose group consumed 10 grams of gluten per day"
10974655|NCT00931892|OG000|Outcome|Day -14 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974656|NCT00931892|OG001|Outcome|Day -14 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974657|NCT00931892|OG002|Outcome|Day 0 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974658|NCT00931892|OG003|Outcome|Day 0 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974659|NCT00931892|OG004|Outcome|Day 3 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974660|NCT00931892|OG005|Outcome|Day 3 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974661|NCT00931892|OG006|Outcome|Day 7 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974662|NCT00931892|OG007|Outcome|Day 7 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974663|NCT00931892|OG008|Outcome|Day 14 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974664|NCT00931892|OG009|Outcome|Day 14 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974665|NCT00931892|OG010|Outcome|Day 28 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974666|NCT00931892|OG011|Outcome|Day 28 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day.
10974667|NCT00931892|OG000|Outcome|Day -14 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974668|NCT00931892|OG001|Outcome|Day -14 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974669|NCT00931892|OG002|Outcome|Day 0 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974670|NCT00931892|OG003|Outcome|Day 0 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974671|NCT00931892|OG004|Outcome|Day 3 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974672|NCT00931892|OG005|Outcome|Day 3 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974673|NCT00931892|OG006|Outcome|Day 7 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974674|NCT00931892|OG007|Outcome|Day 7 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974675|NCT00931892|OG008|Outcome|Day 14 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974676|NCT00931892|OG009|Outcome|Day 14 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974677|NCT00931892|OG010|Outcome|Day 28 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974678|NCT00931892|OG011|Outcome|Day 28 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974679|NCT00931892|OG000|Outcome|Day 14 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day.
10974680|NCT00931892|OG001|Outcome|Day 14 High Gluten Challenge Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974681|NCT00931892|OG002|Outcome|Day 28 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974682|NCT00931892|OG003|Outcome|Day 28 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974683|NCT00931892|OG004|Outcome|Day 14 or Day 28 Low Gluten Dose Group|Subjects in the low gluten dose group consumed 3 grams of gluten per day
10974684|NCT00931892|OG005|Outcome|Day 14 or Day 28 High Gluten Dose Group|Subjects in the high gluten dose group consumed 10 grams of gluten per day
10974685|NCT00931892|EG000|Reported Event|Low Gluten Group|"Subjects will eat 3g of gluten per day~Gluten: 3g"
10974686|NCT00931892|EG001|Reported Event|High Gluten Group|"Subjects will eat 10g of gluten per day~Gluten: 10g"
10974687|NCT00931918|BG000|Baseline|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974688|NCT00931918|BG001|Baseline|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974689|NCT00931918|BG002|Baseline|Total|Total of all reporting groups
10974690|NCT00931918|FG000|Participant Flow|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974691|NCT00931918|FG001|Participant Flow|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974692|NCT00931918|OG000|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974693|NCT00931918|OG001|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974694|NCT00931918|EG000|Reported Event|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974695|NCT00931918|EG001|Reported Event|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
10974696|NCT00931944|BG000|Baseline|300 mg Per Day|KNS-760704 (dexpramipexole) - 150 mg BID
10974697|NCT00931944|FG000|Participant Flow|300 mg Per Day|KNS-760704 (dexpramipexole) - 150 mg BID
10974698|NCT00931944|OG000|Outcome|KNS-760704 300 mg/Day|"Open-label KNS-760704 (150 mg Q12H)~KNS-760704: 150 mg Q12H KNS-760704 given orally (300 mg total daily dose)"
10974699|NCT00931944|EG000|Reported Event|300 mg Per Day|KNS-760704 (dexpramipexole) - 150 mg BID
10974700|NCT00931996|BG000|Baseline|Antipsychotic|Antipsychotic treatment
10974701|NCT00931996|FG000|Participant Flow|Antipsychotic|Antipsychotic treatment
10974702|NCT00931996|OG000|Outcome|Antipsychotic|Antipsychotic treatment
10974703|NCT00931996|EG000|Reported Event|Antipsychotic|Antipsychotic treatment
10974704|NCT00932022|BG000|Baseline|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
10974705|NCT00932022|BG001|Baseline|Placebo|Placebo capsule taken orally once daily for 14 weeks.
10974706|NCT00932022|BG002|Baseline|Total|Total of all reporting groups
10974707|NCT00932022|FG000|Participant Flow|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
10974708|NCT00932022|FG001|Participant Flow|Placebo|Placebo capsule taken orally once daily for 14 weeks.
10974709|NCT00932022|OG000|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
10974710|NCT00932022|OG001|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
10974711|NCT00932022|EG000|Reported Event|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
10826346|NCT00103194|BG000|Baseline|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
10826347|NCT00103194|FG000|Participant Flow|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
10826348|NCT00103194|OG000|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
10826349|NCT00103194|EG000|Reported Event|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
10826350|NCT00103207|BG000|Baseline|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
10826351|NCT00103207|FG000|Participant Flow|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
10826352|NCT00103207|OG000|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
10826353|NCT00103207|OG000|Outcome|Never Smoker|Eligible and treated patients who never smoked.
10826354|NCT00103207|OG001|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
10826355|NCT00103207|EG000|Reported Event|Cetuximab|All treated patients were evaluated for toxicities.
10826356|NCT00103259|BG000|Baseline|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10826357|NCT00103259|BG001|Baseline|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
10826358|NCT00103259|BG002|Baseline|Total|Total of all reporting groups
10826359|NCT00103259|FG000|Participant Flow|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10826360|NCT00103259|FG001|Participant Flow|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
10826361|NCT00103259|OG000|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10826362|NCT00103259|OG001|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
10826363|NCT00103259|OG000|Outcome|Cross-over From Bortezomib to Combined Arm|Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
10826364|NCT00103259|EG000|Reported Event|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10974712|NCT00932022|EG001|Reported Event|Placebo|Placebo capsule taken orally once daily for 14 weeks.
11313022|NCT03193593|FG002|Participant Flow|EB-001 Dose 2 (1.6X)|"2nd Dose in escalation paradigm, 1.6X Dose 1.~Injection of active drug into the pectoralis muscle."
10826365|NCT00103259|EG001|Reported Event|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
10826366|NCT00103259|EG002|Reported Event|Cross-over Patients|11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
10826367|NCT00103285|BG000|Baseline|Group 0 Induction Therapy|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826368|NCT00103285|FG000|Participant Flow|Group 0 Induction Therapy|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826369|NCT00103285|FG001|Participant Flow|Group 1-SR-low ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826370|NCT00103285|FG002|Participant Flow|Group 1-SR-low ALL, Arm II-combination Chemotherapy|"Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826371|NCT00103285|FG003|Participant Flow|Group 2-SR-avg ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826372|NCT00103285|FG004|Participant Flow|Group 2-SR-avg ALL, Arm II-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10848553|NCT00290355|OG001|Outcome|Placebo Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
11313023|NCT03193593|FG003|Participant Flow|EB-001 Dose 3 (3.3X)|"3rd Dose in escalation paradigm, 3.3X Dose 1.~Injection of active drug into the pectoralis muscle."
11313024|NCT03193593|FG004|Participant Flow|EB-001 Dose 4 (6.7X)|"4th Dose in escalation paradigm, 6.7X Dose 1.~Injection of active drug into the pectoralis muscle."
10826373|NCT00103285|FG005|Participant Flow|Group 2-SR-avg ALL, Arm III-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826374|NCT00103285|FG006|Participant Flow|Group 2-SR-avg ALL, Arm IV-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826375|NCT00103285|FG007|Participant Flow|Group 3-SR-high ALL, Combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine & vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine"
10826376|NCT00103285|OG000|Outcome|Group 2-SR-avg ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826377|NCT00103285|OG001|Outcome|Group 2-SR-avg ALL, Arm II-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826378|NCT00103285|OG002|Outcome|Group 2-SR-avg ALL, Arm III-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826379|NCT00103285|OG003|Outcome|Group 2-SR-avg ALL, Arm IV-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10974713|NCT00932035|BG000|Baseline|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
10974714|NCT00932035|BG001|Baseline|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
10974715|NCT00932035|BG002|Baseline|Total|Total of all reporting groups
10974716|NCT00932035|FG000|Participant Flow|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
10974717|NCT00932035|FG001|Participant Flow|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
10974718|NCT00932035|OG000|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
10974719|NCT00932035|OG001|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
10974720|NCT00932035|EG000|Reported Event|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
10974721|NCT00932035|EG001|Reported Event|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
10974722|NCT00932113|BG000|Baseline|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
10974723|NCT00932113|BG001|Baseline|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
10974724|NCT00932113|BG002|Baseline|Total|Total of all reporting groups
10974725|NCT00932113|FG000|Participant Flow|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
10974726|NCT00932113|FG001|Participant Flow|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
10974727|NCT00932113|OG000|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
10974728|NCT00932113|OG001|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
10826380|NCT00103285|OG000|Outcome|SR-low ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826381|NCT00103285|OG001|Outcome|SR-low ALL, Arm II-combination Chemotherapy|"Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826382|NCT00103285|OG000|Outcome|Induction Therapy|All patients for induction therapy.
10826383|NCT00103285|OG000|Outcome|Induction Therapy, MRD Negative|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826384|NCT00103285|OG001|Outcome|Induction Therapy, MRD Positive|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826385|NCT00103285|OG000|Outcome|All Patients for Induction, MRD Negative|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826386|NCT00103285|OG001|Outcome|All Patients for Induction, MRD Positive|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10848554|NCT00290355|EG000|Reported Event|GSK 249553 Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
10848555|NCT00290355|EG001|Reported Event|Placebo Group|Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
10974729|NCT00932113|EG000|Reported Event|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
11313025|NCT03193593|FG005|Participant Flow|EB-001 Dose 5 (10X)|"5th Dose in escalation paradigm, 10X Dose 1.~Injection of active drug into the pectoralis muscle."
10826387|NCT00103285|OG000|Outcome|Induction Therapy|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826388|NCT00103285|OG000|Outcome|Group 3-SR-high ALL, Combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium, and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine,MTX. Patients with DS receive (dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO"
10826389|NCT00103285|OG000|Outcome|Group 1-SR-low ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826390|NCT00103285|OG001|Outcome|Group 2-SR-avg ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826391|NCT00103285|EG000|Reported Event|Group 0 Induction Therapy|"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV"
10826392|NCT00103285|EG001|Reported Event|Group 1-SR-low ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10974730|NCT00932113|EG001|Reported Event|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
10974731|NCT00932126|BG000|Baseline|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID
10974732|NCT00932126|FG000|Participant Flow|PF-03758309, 1 Milligram (mg) Once Daily (QD)|PF-03758309 1 mg administered orally once daily
10974733|NCT00932126|FG001|Participant Flow|PF-03758309, 1 mg Twice Daily (BID)|PF-03758309 1 mg administered orally twice daily
10974734|NCT00932126|FG002|Participant Flow|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
10974735|NCT00932126|FG003|Participant Flow|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
10974736|NCT00932126|FG004|Participant Flow|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
10974737|NCT00932126|FG005|Participant Flow|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
10974738|NCT00932126|FG006|Participant Flow|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
10974739|NCT00932126|FG007|Participant Flow|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice dailly
10974740|NCT00932126|OG000|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
10974741|NCT00932126|OG001|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
10974742|NCT00932126|OG002|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
10974743|NCT00932126|OG003|Outcome|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
10974744|NCT00932126|OG004|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
10974745|NCT00932126|OG005|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
10974746|NCT00932126|OG006|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
10974747|NCT00932126|OG007|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
10974748|NCT00932126|OG003|Outcome|PF-03758309, 10 mg BID|PF-03758309, 10 mg BID PF-03758309 10 mg administered orally twice daily
10974749|NCT00932126|OG000|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
10974750|NCT00932126|EG000|Reported Event|PF-03758309, 1 mg QD|PF-03758309, 1 mg administered orally once daily
10974751|NCT00932126|EG001|Reported Event|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
10974752|NCT00932126|EG002|Reported Event|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
10974753|NCT00932126|EG003|Reported Event|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
10974754|NCT00932126|EG004|Reported Event|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
10974755|NCT00932126|EG005|Reported Event|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
10974756|NCT00932126|EG006|Reported Event|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
10974757|NCT00932126|EG007|Reported Event|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
10974758|NCT00932165|BG000|Baseline|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
10974759|NCT00932165|FG000|Participant Flow|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
10974760|NCT00932165|OG000|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
10974761|NCT00932165|OG000|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
10974762|NCT00932165|EG000|Reported Event|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
10974763|NCT00932282|BG000|Baseline|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
10974764|NCT00932282|BG001|Baseline|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
10974765|NCT00932282|BG002|Baseline|Total|Total of all reporting groups
10974766|NCT00932282|FG000|Participant Flow|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
10974767|NCT00932282|FG001|Participant Flow|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
10974768|NCT00932282|OG000|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
10974769|NCT00932282|OG001|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
10974770|NCT00932282|EG000|Reported Event|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
10974771|NCT00932282|EG001|Reported Event|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
10974772|NCT00932321|BG000|Baseline|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
10974773|NCT00932321|BG001|Baseline|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
10974774|NCT00932321|BG002|Baseline|Total|Total of all reporting groups
10974775|NCT00932321|FG000|Participant Flow|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
10974776|NCT00932321|FG001|Participant Flow|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
10974777|NCT00932321|OG000|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
10974778|NCT00932321|OG001|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
10974779|NCT00932321|EG000|Reported Event|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
10974780|NCT00932321|EG001|Reported Event|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
10974781|NCT00932360|BG000|Baseline|All Study Participants|This is a crossover study with three groups. Subjects completed each arm of the study in random order.
10974782|NCT00932360|FG000|Participant Flow|Active TENS, Placebo TENS and No TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974783|NCT00932360|FG001|Participant Flow|Active TENS No TENS Placebo TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974784|NCT00932360|FG002|Participant Flow|Placebo TENS Active TENS No TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974785|NCT00932360|FG003|Participant Flow|Placebo TENS No TENS Active TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974786|NCT00932360|FG004|Participant Flow|No TENS Active TENS Placebo TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974787|NCT00932360|FG005|Participant Flow|No TENS Placebo TENS Active TENS|Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974788|NCT00932360|OG000|Outcome|Active TENS|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
10974789|NCT00932360|OG001|Outcome|Placebo TENS|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
10974790|NCT00932360|OG002|Outcome|No TENS|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
10974791|NCT00932360|OG000|Outcome|Active TENS to No Treatment to Placebo (ANP)|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
10974792|NCT00932360|OG001|Outcome|Active TENS to Placebo to No Treatment (APN)|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
10974793|NCT00932360|OG002|Outcome|No Treatment to Active TENS to Placebo TENS (NAP)|Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.r
10974794|NCT00932360|OG000|Outcome|Active TENS|100 Hz, 200 μs at maximal tolerable intensity
10974795|NCT00932360|OG001|Outcome|Placebo TENS|TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame
10974796|NCT00932360|OG002|Outcome|No TENS|Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974797|NCT00932360|EG000|Reported Event|Active TENS|100 Hz, 200 μs at maximal tolerable intensity
10974798|NCT00932360|EG001|Reported Event|Placebo TENS|TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame
10974799|NCT00932360|EG002|Reported Event|No TENS|Participants wore a TENS unit that was turned off for blinding of the outcome assessor
10974800|NCT00932373|BG000|Baseline|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
10974801|NCT00932373|BG001|Baseline|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
10974802|NCT00932373|BG002|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
10974803|NCT00932373|BG003|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
10974804|NCT00932373|BG004|Baseline|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
10974805|NCT00932373|BG005|Baseline|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
10974806|NCT00932373|BG006|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
10974807|NCT00932373|BG007|Baseline|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
10974808|NCT00932373|BG008|Baseline|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
10974809|NCT00932373|BG009|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
10974810|NCT00932373|BG010|Baseline|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
10974811|NCT00932373|BG011|Baseline|Total|Total of all reporting groups
10974812|NCT00932373|FG000|Participant Flow|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
10974813|NCT00932373|FG001|Participant Flow|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
10974814|NCT00932373|FG002|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
10974815|NCT00932373|FG003|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
10974816|NCT00932373|FG004|Participant Flow|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
10974817|NCT00932373|FG005|Participant Flow|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
10974818|NCT00932373|FG006|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
10974819|NCT00932373|FG007|Participant Flow|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
10974820|NCT00932373|FG008|Participant Flow|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
10974821|NCT00932373|FG009|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
10974822|NCT00932373|FG010|Participant Flow|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
10826393|NCT00103285|EG002|Reported Event|Group 1-SR-low ALL, Arm II-combination Chemotherapy|"Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826394|NCT00103285|EG003|Reported Event|Group 2-SR-avg ALL, Arm I-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826395|NCT00103285|EG004|Reported Event|Group 2-SR-avg ALL, Arm II-combination Chemotherapy|"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826396|NCT00103285|EG005|Reported Event|Group 2-SR-avg ALL, Arm III-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826397|NCT00103285|EG006|Reported Event|Group 2-SR-avg ALL, Arm IV-combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine: Given PO~cyclophosphamide: Given IV~thioguanine: Given PO~vincristine sulfate: Given IV"
10826398|NCT00103285|EG007|Reported Event|Group 3-SR-high ALL, Combination Chemotherapy|"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine & vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.~doxorubicin hydrochloride: Given IV or IT~3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~leucovorin calcium: Given PO~mercaptopurine"
10826399|NCT00103311|BG000|Baseline|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826400|NCT00103311|BG001|Baseline|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826401|NCT00103311|BG002|Baseline|Total|Total of all reporting groups
10826402|NCT00103311|FG000|Participant Flow|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826403|NCT00103311|FG001|Participant Flow|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10974823|NCT00932373|OG000|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
10826404|NCT00103311|OG000|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826405|NCT00103311|OG001|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826406|NCT00103311|EG000|Reported Event|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826407|NCT00103311|EG001|Reported Event|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
10826408|NCT00103376|BG000|Baseline|Part A Only: Velcade|Patients who were enrolled to Part A but did not move on to Part B.
10826409|NCT00103376|BG001|Baseline|Part B (Velcade + LH-RH Antagonist+Androgen Receptro|Patients who were enrolled only to part B
10826410|NCT00103376|BG002|Baseline|Part A + Part B|Patients who completed part A and moved in to part B.
10826411|NCT00103376|BG003|Baseline|Total|Total of all reporting groups
10826412|NCT00103376|FG000|Participant Flow|Part A Only: Velcade|Patients who were enrolled to Part A but did not move on to Part B
10826413|NCT00103376|FG001|Participant Flow|Part B (Velcade+LH-RH Antagonist+Adrogen Receptor)|Patients who were enrolled only to part B.
10826414|NCT00103376|FG002|Participant Flow|Part A + Part B|Patients who completed part A and moved in to Part B.
10826415|NCT00103376|OG000|Outcome|Part A: Velcade|Patients who were enrolled to Part A but did not move on to Part B
10826416|NCT00103376|OG001|Outcome|Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor)|Patients who were enrolled only to part B.
10826417|NCT00103376|OG002|Outcome|Part A + Part B|Patients who completed part A and moved in to Part B.
10826418|NCT00103376|OG000|Outcome|Part A Only: Velcade|Patients who were enrolled to Part A but did not move on to Part B.
10826419|NCT00103376|OG001|Outcome|Part B and Part A + Part B|Patients who were enrolled to Part B (Velcade + LH-RH Antagonist+Androgen Receptor) and Part A (Velcade only) + Part B
10826420|NCT00103376|OG000|Outcome|Part A Only: Velcade|Patients who were enrolled to Part A but did not move on to Part B
10826421|NCT00103376|OG001|Outcome|Part B (Velcade+Lh-RH Antagonist+ Androgen Receptor)|patients who were enrolled only to Part B.
10826422|NCT00103376|OG002|Outcome|Part A + Part B|Patients who completed Part A and moved in to Part B
10826423|NCT00103376|OG000|Outcome|Velcade and Hormonal Therapy|"Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Velcade + Antiandrogen therapy. If the patient has a partial response or stable disease, he will start Velcade+antiandrogen after at least a 7-day break.~After 3 months on Part B, if the patient has a complete response, he will come off study. Patients with a partial response or stable disease will repeat part B. Patients with progressive disease will come off study.~Velcade: Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.~Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break~LH-RH Agonist: given as a 3 month depo-injection~Androgen Receptor Antagonists: given orally daily for 3 months"
10826424|NCT00103376|EG000|Reported Event|Part A: Velcade Only|Patients who were enrolled to Part A but did not move on to Part B
10826425|NCT00103376|EG001|Reported Event|Part B (Velcade+LH-RH Antagonist+Adrogen Receptor)|Patients who were enrolled only to part B.
10826426|NCT00103376|EG002|Reported Event|Part A + Part B|Patients who completed part A and moved in to Part B.
10826427|NCT00103402|BG000|Baseline|Alfuzosin|10 mg of alfuzosin once daily for 12 weeks
10826428|NCT00103402|BG001|Baseline|Placebo|10 mg of an identical-looking placebo once daily for 12 weeks
10826429|NCT00103402|BG002|Baseline|Total|Total of all reporting groups
10826430|NCT00103402|FG000|Participant Flow|Alfuzosin|10 mg of alfuzosin once daily for 12 weeks
10826431|NCT00103402|FG001|Participant Flow|Placebo|10 mg of an identical-looking placebo once daily for 12 weeks
10826432|NCT00103402|OG000|Outcome|Alfuzosin|10 mg of alfuzosin once daily for 12 weeks
10826433|NCT00103402|OG001|Outcome|Placebo|10 mg of an identical-looking placebo once daily for 12 weeks
10826434|NCT00103402|EG000|Reported Event|Alfuzosin|10 mg of alfuzosin once daily for 12 weeks
10826435|NCT00103402|EG001|Reported Event|Placebo|10 mg of an identical-looking placebo once daily for 12 weeks
10826436|NCT00103506|BG000|Baseline|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
10826437|NCT00103506|BG001|Baseline|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
10826438|NCT00103506|BG002|Baseline|Total|Total of all reporting groups
10826439|NCT00103506|FG000|Participant Flow|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
10826440|NCT00103506|FG001|Participant Flow|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
10826441|NCT00103506|OG000|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
10974824|NCT00932373|OG001|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
10974825|NCT00932373|OG002|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
10974826|NCT00932373|OG003|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
10974827|NCT00932373|OG004|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
10974828|NCT00932373|OG005|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
10974829|NCT00932373|OG006|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
10974830|NCT00932373|OG007|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
10974831|NCT00932373|OG008|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
10974832|NCT00932373|OG009|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
10974833|NCT00932373|OG010|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
10974834|NCT00932373|OG000|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
10974835|NCT00932373|OG001|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
10974836|NCT00932373|OG002|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
10974837|NCT00932373|OG003|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
10974838|NCT00932373|OG004|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
10974839|NCT00932373|OG005|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
10974840|NCT00932373|OG000|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
10974841|NCT00932373|OG001|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
10974842|NCT00932373|EG000|Reported Event|Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
10974843|NCT00932373|EG001|Reported Event|Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
10974844|NCT00932373|EG002|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
10974845|NCT00932373|EG003|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
10974846|NCT00932373|EG004|Reported Event|Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
10974847|NCT00932373|EG005|Reported Event|Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
10974848|NCT00932373|EG006|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Weekly|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
10974849|NCT00932373|EG007|Reported Event|Trastuzumab-MCC-DM 1.6 mg/kg Weekly|Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
10974850|NCT00932373|EG008|Reported Event|Trastuzumab-MCC-DM 2.0 mg/kg Weekly|Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
10974851|NCT00932373|EG009|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Weekly|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
10974852|NCT00932373|EG010|Reported Event|Trastuzumab-MCC-DM 2.9 mg/kg Weekly|2.9 mg/kg administered intravenously (IV) once a week
10974853|NCT00932399|BG000|Baseline|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
10974854|NCT00932399|BG001|Baseline|Group 2|No history of lower limb amputation
10974855|NCT00932399|BG002|Baseline|Total|Total of all reporting groups
10974856|NCT00932399|FG000|Participant Flow|Group 1|Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
10974857|NCT00932399|FG001|Participant Flow|Group 2|No history of lower limb amputation
10974858|NCT00932399|OG000|Outcome|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
10974859|NCT00932399|OG001|Outcome|Group 2|No history of lower limb amputation
10974860|NCT00932399|EG000|Reported Event|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
10974861|NCT00932399|EG001|Reported Event|Group 2|No history of lower limb amputation
10974862|NCT00932425|BG000|Baseline|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
10974863|NCT00932425|BG001|Baseline|Control|Patients discharged home with standard clinical follow-up
10974864|NCT00932425|BG002|Baseline|Total|Total of all reporting groups
10974865|NCT00932425|FG000|Participant Flow|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
10974866|NCT00932425|FG001|Participant Flow|Control|Patients discharged home with standard clinical follow-up
10974867|NCT00932425|OG000|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
10974868|NCT00932425|OG001|Outcome|Control|Patients discharged home with standard clinical follow-up
10974869|NCT00932425|EG000|Reported Event|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
10974870|NCT00932425|EG001|Reported Event|Control|Patients discharged home with standard clinical follow-up
10974871|NCT00932438|BG000|Baseline|LC Beads Loaded With Irinotecan and FOLFOX6|"Device: LC Beads loaded with 100mg Irinotecan~Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974872|NCT00932438|BG001|Baseline|FOLFOX6 and Bevacizumab|"Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974873|NCT00932438|BG002|Baseline|Total|Total of all reporting groups
10974874|NCT00932438|FG000|Participant Flow|Irinotecan Beads With FOLFOX6|LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan in combination with Fluorouracil, Oxaliplatin, Leucovorin and Avastin alternating on a 2 week schedule
10974875|NCT00932438|FG001|Participant Flow|FOLFOX6/Avastin Alone|FOLFOX6 and Avastin: Fluorouracil, Oxaliplatin, Leucovorin and Avastin given biweekly
10974876|NCT00932438|OG000|Outcome|LC Beads Loaded With Irinotecan and FOLFOX6|"Device: LC Beads loaded with 100mg Irinotecan~Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974877|NCT00932438|OG001|Outcome|FOLFOX6 and Bevacizumab|"Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974878|NCT00932438|OG000|Outcome|Irinotecan Beads With FOLFOX6|LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan in combination with Fluorouracil, Oxaliplatin, Leucovorin and Avastin alternating on a 2 week schedule
10974879|NCT00932438|OG001|Outcome|FOLFOX6/Avastin Alone|FOLFOX6 and Avastin: Fluorouracil, Oxaliplatin, Leucovorin and Avastin given biweekly
10974880|NCT00932438|EG000|Reported Event|LC Beads Loaded With Irinotecan and FOLFOX6|"Device: LC Beads loaded with 100mg Irinotecan~Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974881|NCT00932438|EG001|Reported Event|FOLFOX6 and Bevacizumab|"Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician~Oxaliplatin~Leucovorin~5-Fluorouracil~Bevacizumab"
10974882|NCT00932451|BG000|Baseline|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974883|NCT00932451|FG000|Participant Flow|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974884|NCT00932451|OG000|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974885|NCT00932451|OG000|Outcome|Crizotinib (PF-02341066)|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974886|NCT00932451|OG001|Outcome|PF-06260182|PF-06260182 was a PF-02341066 metabolite measured in this study.
10974887|NCT00932451|OG000|Outcome|Crizotinib 250 mg BID-ALT Cases|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974888|NCT00932451|OG001|Outcome|Crizotinib 250 mg BID-ALT Controls|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974889|NCT00932451|EG000|Reported Event|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
10974890|NCT00932477|BG000|Baseline|All Study Participants|All Study Participants
10974891|NCT00932477|FG000|Participant Flow|Sequence ABC|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
10974892|NCT00932477|FG001|Participant Flow|Sequence ACB|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
10974893|NCT00932477|FG002|Participant Flow|Sequence BAC|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
10974894|NCT00932477|FG003|Participant Flow|Sequence BCA|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
10974895|NCT00932477|FG004|Participant Flow|Sequence CAB|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
10974896|NCT00932477|FG005|Participant Flow|Sequence CBA|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
10974897|NCT00932477|OG000|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
10974898|NCT00932477|OG001|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
10974899|NCT00932477|OG002|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10974900|NCT00932477|EG000|Reported Event|Artificial Tear Formulation 1|Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
10974901|NCT00932477|EG001|Reported Event|Artificial Tear Formulation 2|Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
10974902|NCT00932477|EG002|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
10974903|NCT00932620|BG000|Baseline|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
10974904|NCT00932620|BG001|Baseline|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
10974905|NCT00932620|BG002|Baseline|Total|Total of all reporting groups
10974906|NCT00932620|FG000|Participant Flow|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
10974907|NCT00932620|FG001|Participant Flow|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
10974908|NCT00932620|OG000|Outcome|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
10974909|NCT00932620|OG001|Outcome|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
10974910|NCT00932620|OG000|Outcome|Simvastatin 40|
10974911|NCT00932620|OG001|Outcome|Simvastatin/Ezetimibe 10/10|
10974912|NCT00932620|EG000|Reported Event|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
10974913|NCT00932620|EG001|Reported Event|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
10974914|NCT00932646|BG000|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
10974915|NCT00932646|FG000|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974916|NCT00932646|FG001|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974917|NCT00932646|FG002|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974918|NCT00932646|FG003|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
10974919|NCT00932646|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
10974920|NCT00932646|OG001|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974921|NCT00932646|OG002|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974922|NCT00932646|OG003|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974923|NCT00932646|OG000|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974924|NCT00932646|OG001|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974925|NCT00932646|OG002|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974926|NCT00932646|OG003|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974927|NCT00932646|EG000|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
10974928|NCT00932646|EG001|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
10974929|NCT00932646|EG002|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
10974930|NCT00932646|EG003|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
10974931|NCT00932659|BG000|Baseline|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
10974932|NCT00932659|FG000|Participant Flow|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
10974933|NCT00932659|OG000|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
10974934|NCT00932659|EG000|Reported Event|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
10974935|NCT00932698|BG000|Baseline|Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2|Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
10974936|NCT00932698|BG001|Baseline|Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2|Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
10974937|NCT00932698|BG002|Baseline|Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2|Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
10974938|NCT00932698|BG003|Baseline|Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2|Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
10974939|NCT00932698|BG004|Baseline|Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2|Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
10974940|NCT00932698|BG005|Baseline|Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
10974941|NCT00932698|BG006|Baseline|Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2|Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
10974942|NCT00932698|BG007|Baseline|Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
10974943|NCT00932698|BG008|Baseline|Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
10974944|NCT00932698|BG009|Baseline|Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
10974945|NCT00932698|BG010|Baseline|Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
10974946|NCT00932698|BG011|Baseline|Total|Total of all reporting groups
11313026|NCT03193593|FG006|Participant Flow|EB-001 Dose 6 (13.3X)|"6th Dose in escalation paradigm, 13.3X Dose 1.~Injection of active drug into the pectoralis muscle."
10974947|NCT00932698|FG000|Participant Flow|Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2|Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
10974948|NCT00932698|FG001|Participant Flow|Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2|Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
10974949|NCT00932698|FG002|Participant Flow|Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2|Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
10974950|NCT00932698|FG003|Participant Flow|Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2|Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
10974951|NCT00932698|FG004|Participant Flow|Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2|Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
10974952|NCT00932698|FG005|Participant Flow|Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
10974953|NCT00932698|FG006|Participant Flow|Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2|Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
10974954|NCT00932698|FG007|Participant Flow|Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
10974955|NCT00932698|FG008|Participant Flow|Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
10974956|NCT00932698|FG009|Participant Flow|Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
10974957|NCT00932698|FG010|Participant Flow|Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
10974958|NCT00932698|OG000|Outcome|Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2|Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
10974959|NCT00932698|OG001|Outcome|Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2|Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
10974960|NCT00932698|OG002|Outcome|Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2|Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
10974961|NCT00932698|OG003|Outcome|Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2|Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
10974962|NCT00932698|OG004|Outcome|Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2|Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
10974963|NCT00932698|OG005|Outcome|Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
10974964|NCT00932698|OG006|Outcome|Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2|Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
10974965|NCT00932698|OG007|Outcome|Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
10974966|NCT00932698|OG008|Outcome|Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
10974967|NCT00932698|OG009|Outcome|Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
10974968|NCT00932698|OG010|Outcome|Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
10974969|NCT00932698|OG000|Outcome|Ixazomib (All Groups)|All participants who received ixazomib 0.24 mg/m^2, 0.48 mg/m^2, 0.8 mg/m^2, 1.2 mg/m^2, 1.68 mg/m^2, 2 mg/m^2 or 2.23 mg/m^2 in dose-escalation cohorts.
10974970|NCT00932698|OG008|Outcome|VELCADE-Relapsed Expansion Cohort: MLN9708 2.0 mg/m^2|Ixazomib (MLN9708) 2 mg/m^2 (MTD), capsule, orally, twice weekly on Days 1, 4, 8 and 11 in 21-day treatment cycles until PD or unacceptable toxicity in participants with relapsed multiple myeloma previously treated with VELCADE during Part 2 (dose expansion cohort) of the study.
10974971|NCT00932698|EG000|Reported Event|Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2|Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
10974972|NCT00932698|EG001|Reported Event|Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2|Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
10974973|NCT00932698|EG002|Reported Event|Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2|Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
10974974|NCT00932698|EG003|Reported Event|Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2|Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
10974975|NCT00932698|EG004|Reported Event|Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2|Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
10974976|NCT00932698|EG005|Reported Event|Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
10974977|NCT00932698|EG006|Reported Event|Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2|Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
10974978|NCT00932698|EG007|Reported Event|Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
10974979|NCT00932698|EG008|Reported Event|Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
10974980|NCT00932698|EG009|Reported Event|Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
10974981|NCT00932698|EG010|Reported Event|Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2|Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
10974982|NCT00932828|BG000|Baseline|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed ITT.
10974983|NCT00932828|FG000|Participant Flow|Peanut Oral Immunotherapy|All subjects are treated with peanut oral immunotherapy for primary outcome. Patients randomized to 300mg or 3000mg for secondary dose finding outcome.
10974984|NCT00932828|OG000|Outcome|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
10974985|NCT00932828|EG000|Reported Event|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
10974986|NCT00932893|BG000|Baseline|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974987|NCT00932893|BG001|Baseline|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974988|NCT00932893|BG002|Baseline|Total|Total of all reporting groups
10974989|NCT00932893|FG000|Participant Flow|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974990|NCT00932893|FG001|Participant Flow|Chemotherapy|Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974991|NCT00932893|OG000|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974992|NCT00932893|OG001|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974993|NCT00932893|OG000|Outcome|Overall Values|Overall assessment for complete response, partial response, stable disease, progressive disease and early death
10974994|NCT00932893|EG000|Reported Event|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974995|NCT00932893|EG001|Reported Event|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
10974996|NCT00933166|BG000|Baseline|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
10974997|NCT00933166|FG000|Participant Flow|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
10974998|NCT00933166|OG000|Outcome|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
10974999|NCT00933166|EG000|Reported Event|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
10975000|NCT00933244|BG000|Baseline|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975001|NCT00933244|BG001|Baseline|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
10975002|NCT00933244|BG002|Baseline|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975003|NCT00933244|BG003|Baseline|Total|Total of all reporting groups
10975004|NCT00933244|FG000|Participant Flow|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975005|NCT00933244|FG001|Participant Flow|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
10975006|NCT00933244|FG002|Participant Flow|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975007|NCT00933244|OG000|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975008|NCT00933244|OG001|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
10975009|NCT00933244|OG002|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975010|NCT00933244|EG000|Reported Event|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975011|NCT00933244|EG001|Reported Event|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
10975012|NCT00933244|EG002|Reported Event|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
10975013|NCT00933270|BG000|Baseline|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
10975014|NCT00933270|FG000|Participant Flow|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
10975015|NCT00933270|OG000|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
10975016|NCT00933270|EG000|Reported Event|Supera® Peripheral Stent System ITT|"Implantation of Supera stent using the Supera® Peripheral Stent System.~ITT population consisted of 264 subjects."
10975017|NCT00933270|EG001|Reported Event|Supera® Peripheral Stent System Roll-in|"Implantation of Supera stent using the Supera® Peripheral Stent System.~There were a total of 61 roll-in subjects."
10975018|NCT00933335|BG000|Baseline|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
10975019|NCT00933335|BG001|Baseline|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol's solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
10975020|NCT00933335|BG002|Baseline|Total|Total of all reporting groups
10975021|NCT00933335|FG000|Participant Flow|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
11313027|NCT03193593|OG000|Outcome|Placebo Injections|Placebo Injection into the Pectoralis Muscle
11313028|NCT03193593|OG001|Outcome|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Injection of active drug into the pectoralis muscle"
11313029|NCT03193593|OG002|Outcome|EB-001 Dose 2 (1.6X)|"2nd Dose in escalation paradigm, 1.6X Dose 1.~Injection of active drug into the pectoralis muscle."
11313030|NCT03193593|OG003|Outcome|EB-001 Dose 3 (3.3X)|"3rd Dose in escalation paradigm, 3.3X Dose 1.~Injection of active drug into the pectoralis muscle."
10975022|NCT00933335|FG001|Participant Flow|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol's solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
10975023|NCT00933335|OG000|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
10975024|NCT00933335|OG001|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
10975025|NCT00933335|OG002|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
10975026|NCT00933335|OG000|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
10975027|NCT00933335|OG000|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
10975028|NCT00933335|OG001|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
10975029|NCT00933335|OG001|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
10975030|NCT00933335|EG000|Reported Event|Fludarabine|Participants who received any number of cycles of IV fludarabine monophosphate (25 mg/m^2/day). Each cycle was administered for 5 days every 5 to 6 weeks.
11313031|NCT03193593|OG004|Outcome|EB-001 Dose 4 (6.7X)|"4th Dose in escalation paradigm, 6.7X Dose 1.~Injection of active drug into the pectoralis muscle."
11313032|NCT03193593|OG005|Outcome|EB-001 Dose 5 (10X)|"5th Dose in escalation paradigm, 10X Dose 1.~Injection of active drug into the pectoralis muscle."
10975031|NCT00933335|EG001|Reported Event|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
10975032|NCT00933335|EG002|Reported Event|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
10975033|NCT00933491|BG000|Baseline|Diabetic|Type II Diabetes
10975034|NCT00933491|BG001|Baseline|Control|Non-diabetics
10975035|NCT00933491|BG002|Baseline|Total|Total of all reporting groups
10975036|NCT00933491|FG000|Participant Flow|Diabetic|Type II Diabetes
10975037|NCT00933491|FG001|Participant Flow|Control|Non-diabetics
10975038|NCT00933491|OG000|Outcome|Diabetic|Type II Diabetes
10975039|NCT00933491|OG001|Outcome|Control|Non-diabetics
10975040|NCT00933491|EG000|Reported Event|Diabetic|Type II Diabetes
10975041|NCT00933491|EG001|Reported Event|Control|Non-diabetics
10975042|NCT00933543|BG000|Baseline|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
10975043|NCT00933543|BG001|Baseline|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
10975044|NCT00933543|BG002|Baseline|Total|Total of all reporting groups
10975045|NCT00933543|FG000|Participant Flow|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
10975046|NCT00933543|FG001|Participant Flow|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
11313033|NCT03193593|OG006|Outcome|EB-001 Dose 6 (13.3X)|"6th Dose in escalation paradigm, 13.3X Dose 1.~Injection of active drug into the pectoralis muscle."
10975047|NCT00933543|OG000|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
10975048|NCT00933543|OG001|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
10975049|NCT00933543|EG000|Reported Event|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
10975050|NCT00933543|EG001|Reported Event|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
10975051|NCT00933608|BG000|Baseline|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
10975052|NCT00933608|BG001|Baseline|Placebo|
10975053|NCT00933608|BG002|Baseline|Total|Total of all reporting groups
10975054|NCT00933608|FG000|Participant Flow|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
10975055|NCT00933608|FG001|Participant Flow|Placebo|participants were taking 1 tablet twice a day to match memantine arm
10975056|NCT00933608|OG000|Outcome|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
10975057|NCT00933608|OG001|Outcome|Placebo|participant will be taking 1 tablet twice a day to match active arm
10975058|NCT00933608|EG000|Reported Event|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
10975059|NCT00933608|EG001|Reported Event|Placebo|
10975060|NCT00933686|BG000|Baseline|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
10975061|NCT00933686|BG001|Baseline|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
10975062|NCT00933686|BG002|Baseline|Total|Total of all reporting groups
10975063|NCT00933686|FG000|Participant Flow|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
10975064|NCT00933686|FG001|Participant Flow|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
10975065|NCT00933686|OG000|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
11313034|NCT03193593|EG000|Reported Event|Placebo Injections|Placebo Injection into the Pectoralis Muscle
11313035|NCT03193593|EG001|Reported Event|EB-001 Dose 1 (1X)|"1st Dose in escalation paradigm.~Injection of active drug into the pectoralis muscle"
11313036|NCT03193593|EG002|Reported Event|EB-001 Dose 2 (1.6X)|"2nd Dose in escalation paradigm, 1.6X Dose 1.~Injection of active drug into the pectoralis muscle."
10975066|NCT00933686|OG001|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
10975067|NCT00933686|EG000|Reported Event|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
10975068|NCT00933686|EG001|Reported Event|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
10975069|NCT00933933|BG000|Baseline|Architect HIV Ag/Ab Combo Specificity|Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
10975070|NCT00933933|BG001|Baseline|Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
10975071|NCT00933933|BG002|Baseline|Architect Ag/Ab Combo HIV-1 Antibody Sensitivity|Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
10975072|NCT00933933|BG003|Baseline|Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
10975073|NCT00933933|BG004|Baseline|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
10975074|NCT00933933|BG005|Baseline|Total|Total of all reporting groups
10975075|NCT00933933|FG000|Participant Flow|Architect HIV Ag/Ab Combo Specificity|"Specificity populations included:~6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.~448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.~588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
10975076|NCT00933933|FG001|Participant Flow|Architect HIV Ag/Ab Combo Sensitivity|"Sensitivity populations included:~1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.~67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.~64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test."
10975077|NCT00933933|FG002|Participant Flow|Architect HIV Ag/Ab Combo Reactivity|"Reactivty populations included:~1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.~203 specimen from pregnant females at risk for HIV infection.~Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
10975078|NCT00933933|OG000|Outcome|Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection|Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
10975079|NCT00933933|OG000|Outcome|HIV p24 Antgen Sensitivity|HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.
10975080|NCT00933933|OG001|Outcome|HIV-1 Antibody Sensitivity|Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
10975081|NCT00933933|OG002|Outcome|HIV-2 Antibody Sensitivity|Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
10975082|NCT00933933|OG000|Outcome|Architect HIV Ag/Ab Combo Specificity in Pregnant Females|HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.
10975083|NCT00933933|OG001|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females|HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.
10975084|NCT00933933|OG000|Outcome|Architect HIV Ag/Ab Combo Specificity in Pediatric Population|Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.
10975085|NCT00933933|OG001|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population|Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.
10975086|NCT00933933|OG000|Outcome|Increased Risk for HIV in US Population|Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.
10975087|NCT00933933|OG001|Outcome|Increased Risk for HIV From HIV-2 Endemic Area|Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test.
11313037|NCT03193593|EG003|Reported Event|EB-001 Dose 3 (3.3X)|"3rd Dose in escalation paradigm, 3.3X Dose 1.~Injection of active drug into the pectoralis muscle."
10975088|NCT00933933|OG002|Outcome|Reactivity in Pregnant Female Population|Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.
10975089|NCT00933933|EG000|Reported Event|Architect HIV Ag/Ab Combo Specificity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
10975090|NCT00933933|EG001|Reported Event|Architect HIV Ag/Ab Combo Sensitivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
10975091|NCT00933933|EG002|Reported Event|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
10975092|NCT00934024|BG000|Baseline|Abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was abstinent after 5 weeks of varenicline treatment."
10975093|NCT00934024|BG001|Baseline|Non-Abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was participants who continued to smoke after 5 weeks of varenicline treatment."
10975094|NCT00934024|BG002|Baseline|Total|Total of all reporting groups
10975095|NCT00934024|FG000|Participant Flow|Abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was abstinent after 5 weeks of varenicline treatment."
10975096|NCT00934024|FG001|Participant Flow|Non-abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was people who continued to smoke after 5 weeks of varenicline treatment."
10975097|NCT00934024|OG000|Outcome|Abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was abstinent after 5 weeks of varenicline treatment..~varenicline: Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months."
10975098|NCT00934024|OG001|Outcome|Non-abstinent|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~This arm was participants who continued to smoke after 5 weeks of varenicline treatment.~varenicline: Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months."
10975099|NCT00934024|EG000|Reported Event|All Participants|"All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.~Adverse events are reported for the total of all participants. Since all patients received medication, DSMB reports were made in aggregate and are reported as such here."
10975100|NCT00934050|BG000|Baseline|Placebo/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975101|NCT00934050|BG001|Baseline|250mg BID/2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
11313038|NCT03193593|EG004|Reported Event|EB-001 Dose 4 (6.7X)|"4th Dose in escalation paradigm, 6.7X Dose 1.~Injection of active drug into the pectoralis muscle."
10975102|NCT00934050|BG002|Baseline|1000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975103|NCT00934050|BG003|Baseline|2000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975104|NCT00934050|BG004|Baseline|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975105|NCT00934050|BG005|Baseline|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975106|NCT00934050|BG006|Baseline|Total|Total of all reporting groups
10975107|NCT00934050|FG000|Participant Flow|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975108|NCT00934050|FG001|Participant Flow|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975109|NCT00934050|FG002|Participant Flow|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
11313039|NCT03193593|EG005|Reported Event|EB-001 Dose 5 (10X)|"5th Dose in escalation paradigm, 10X Dose 1.~Injection of active drug into the pectoralis muscle."
10975110|NCT00934050|FG003|Participant Flow|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975111|NCT00934050|FG004|Participant Flow|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975112|NCT00934050|FG005|Participant Flow|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975113|NCT00934050|OG000|Outcome|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975114|NCT00934050|OG001|Outcome|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975115|NCT00934050|EG000|Reported Event|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975116|NCT00934050|EG001|Reported Event|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975117|NCT00934050|EG002|Reported Event|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975118|NCT00934050|EG003|Reported Event|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
10975119|NCT00934050|EG004|Reported Event|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975120|NCT00934050|EG005|Reported Event|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
10975121|NCT00934089|BG000|Baseline|Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle|Participants self-administered 1 drop (27 microliter [mcL]) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.
10975122|NCT00934089|BG001|Baseline|Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then latanoprost 0.005% ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.
10975123|NCT00934089|BG002|Baseline|Total|Total of all reporting groups
10975124|NCT00934089|FG000|Participant Flow|Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle|Participants self-administered 1 drop (27 microliter [mcL]) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.
10975125|NCT00934089|FG001|Participant Flow|Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then latanoprost 0.005% ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.
10975126|NCT00934089|OG000|Outcome|Taprenepag+Latanoprost|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
10975127|NCT00934089|OG001|Outcome|Taprenepag+Latanoprost Vehicle|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
11313040|NCT03193593|EG006|Reported Event|EB-001 Dose 6 (13.3X)|"6th Dose in escalation paradigm, 13.3X Dose 1.~Injection of active drug into the pectoralis muscle."
11313041|NCT03193736|BG000|Baseline|Implant|"MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.~The intervention is to be performed as stand-alone surgery."
11313042|NCT03193736|FG000|Participant Flow|Implant|"MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.~The intervention is to be performed as stand-alone surgery."
11313043|NCT03193736|OG000|Outcome|Implant|"MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.~The intervention is to be performed as stand-alone surgery."
11313044|NCT03193736|EG000|Reported Event|Implant|"MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.~The intervention is to be performed as stand-alone surgery."
11313045|NCT03194217|BG000|Baseline|Placebo|"Placebo comparator~Placebo: Placebo"
11313046|NCT03194217|BG001|Baseline|BEN-2001, 0.5mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313047|NCT03194217|BG002|Baseline|BEN-2001, 1.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313048|NCT03194217|BG003|Baseline|BEN-2001, 3.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313049|NCT03194217|BG004|Baseline|Total|Total of all reporting groups
11313050|NCT03194217|FG000|Participant Flow|Placebo|"Placebo comparator~Placebo: Placebo"
11313051|NCT03194217|FG001|Participant Flow|BEN-2001, 0.5mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313052|NCT03194217|FG002|Participant Flow|BEN-2001, 1.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313053|NCT03194217|FG003|Participant Flow|BEN-2001, 3.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313054|NCT03194217|OG000|Outcome|Placebo|"Placebo comparator~Placebo: Placebo"
11313055|NCT03194217|OG001|Outcome|BEN-2001, 0.5mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313056|NCT03194217|OG002|Outcome|BEN-2001, 1.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313057|NCT03194217|OG003|Outcome|BEN-2001, 3.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313058|NCT03194217|EG000|Reported Event|Placebo|"Placebo comparator~Placebo: Placebo"
11313059|NCT03194217|EG001|Reported Event|BEN-2001, 0.5mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313060|NCT03194217|EG002|Reported Event|BEN-2001, 1.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313061|NCT03194217|EG003|Reported Event|BEN-2001, 3.0mg|"Experimental treatment~BEN-2001: Bavisant dihydrochloride monohydrate for oral use"
11313062|NCT03194334|BG000|Baseline|Control|continued their omnivorous diet throughout the entire study
11313063|NCT03194334|BG001|Baseline|Veg+Pla|"vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine~Vegetarian diet~Placebo: pills"
11313064|NCT03194334|BG002|Baseline|Veg+Suppl|"switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day~Vegetarian diet~creatine and beta-alanine"
11313065|NCT03194334|BG003|Baseline|Total|Total of all reporting groups
11313066|NCT03194334|FG000|Participant Flow|Control|continued their omnivorous diet throughout the entire study
11313067|NCT03194334|FG001|Participant Flow|Veg+Pla|"vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine~Vegetarian diet~Placebo: pills"
11313068|NCT03194334|FG002|Participant Flow|Veg+Suppl|"switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day~Vegetarian diet~creatine and beta-alanine"
11313069|NCT03194334|OG000|Outcome|Control|continued their omnivorous diet throughout the entire study
11313070|NCT03194334|OG001|Outcome|Veg+Pla|"vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine~Vegetarian diet~Placebo: pills"
11313071|NCT03194334|OG002|Outcome|Veg+Suppl|"switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day~Vegetarian diet~creatine and beta-alanine"
11313072|NCT03194334|OG002|Outcome|Veg+ Creatine and Beta-alanine|"switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day~Vegetarian diet~creatine: 1g creatine/day~Beta-alanine: 0.8g beta-alanine per day"
11313073|NCT03194334|EG000|Reported Event|Control|continued their omnivorous diet throughout the entire study
11313074|NCT03194334|EG001|Reported Event|Veg+Pla|"vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine~Vegetarian diet~Placebo: pills"
11313075|NCT03194334|EG002|Reported Event|Veg+Suppl|"switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day~Vegetarian diet~creatine and beta-alanine"
11313076|NCT03194373|BG000|Baseline|Palbociclib and Carboplatin|"Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days.~Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days."
11313077|NCT03194373|FG000|Participant Flow|Palbociclib and Carboplatin|"Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days.~Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days."
10975128|NCT00934089|EG000|Reported Event|Taprenepag+Latanoprost|Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
10975129|NCT00934089|EG001|Reported Event|Taprenepag+Latanoprost Vehicle|Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
10975130|NCT00934102|BG000|Baseline|Overall|This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
10975131|NCT00934102|FG000|Participant Flow|Narafilcon A / Lotrafilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
10975132|NCT00934102|FG001|Participant Flow|Narafilcon A / Galyfilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
10975133|NCT00934102|FG002|Participant Flow|Lotrafilcon A / Galyfilcon A|Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
10975134|NCT00934102|OG000|Outcome|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975135|NCT00934102|OG001|Outcome|Narafilcon A|Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975136|NCT00934102|OG002|Outcome|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975137|NCT00934102|EG000|Reported Event|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975138|NCT00934102|EG001|Reported Event|Narafilcon A|Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975139|NCT00934102|EG002|Reported Event|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
10975140|NCT00934128|BG000|Baseline|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
10975141|NCT00934128|BG001|Baseline|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
10975142|NCT00934128|BG002|Baseline|Total|Total of all reporting groups
10975143|NCT00934128|FG000|Participant Flow|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.
10975144|NCT00934128|FG001|Participant Flow|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
10975145|NCT00934128|OG000|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
10975146|NCT00934128|OG001|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
10975147|NCT00934128|EG000|Reported Event|Group1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.
10975148|NCT00934128|EG001|Reported Event|Group 2: Vapotherm Then BiPAP|Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
10975149|NCT00934141|BG000|Baseline|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
10975150|NCT00934141|BG001|Baseline|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
10975151|NCT00934141|BG002|Baseline|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
10975152|NCT00934141|BG003|Baseline|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
10975153|NCT00934141|BG004|Baseline|Total|Total of all reporting groups
10975154|NCT00934141|FG000|Participant Flow|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
10975155|NCT00934141|FG001|Participant Flow|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
10975156|NCT00934141|FG002|Participant Flow|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
10826442|NCT00103506|OG001|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
10826443|NCT00103506|EG000|Reported Event|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
10826444|NCT00103506|EG001|Reported Event|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
10826445|NCT00103610|BG000|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826446|NCT00103610|BG001|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826447|NCT00103610|BG002|Baseline|Total|Total of all reporting groups
10826448|NCT00103610|FG000|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826449|NCT00103610|FG001|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826450|NCT00103610|OG000|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826451|NCT00103610|OG001|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826452|NCT00103610|OG000|Outcome|G-CSF + Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826453|NCT00103610|EG000|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826454|NCT00103610|EG001|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
10826455|NCT00103662|BG000|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826456|NCT00103662|BG001|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826457|NCT00103662|BG002|Baseline|Total|Total of all reporting groups
10826458|NCT00103662|FG000|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826459|NCT00103662|FG001|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826460|NCT00103662|OG000|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826461|NCT00103662|OG001|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
11313078|NCT03194373|OG000|Outcome|Palbociclib and Carboplatin|"Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days.~Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days."
11313079|NCT03194373|EG000|Reported Event|Palbociclib and Carboplatin|"Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days.~Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days."
11313080|NCT03194464|BG000|Baseline|Task-failure, Extended Session|Exercise to fatigue followed by repeated monitoring of recovery until 3:45 after.
11313081|NCT03194464|FG000|Participant Flow|Task-Failure, Extended Session|individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke performed submaximal exercise (grip): participants performed submaximal gripping with the non-paretic hand to task failure, guided by visual feedback. Recovery was monitored for an extended period of 3:45 following task-failure.
11313082|NCT03194464|OG000|Outcome|Task-Failure, Extended Session|"individuals with upper-extremity impairment following stroke~submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure"
11313083|NCT03194464|OG000|Outcome|Task-failure, Repeated Sessions|Individuals with upper-extremity motor impairment following stroke. Performed 8 repeated sessions of exercise to task-failure (2x per week x 4 weeks)
11313084|NCT03194464|OG000|Outcome|Task-failure, Extended Session|"individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke~submaximal exercise (grip): participants performed repeated gripping with the non-paretic hand to task failure. Visual feedback was provided."
11313085|NCT03194464|EG000|Reported Event|Task-failure, Extended Session|"individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke~submaximal exercise (grip): participants performed repeated gripping with the non-paretic hand to task failure. Visual feedback was provided."
11313086|NCT03194490|BG000|Baseline|The Combined Intervention Group|"The combined intervention group: The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).~Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques were selected by the physical therapist based on the participant's condition.~Stretching exercise will be given to the participants by the physical therapist. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor muscles and interspinous muscles."
11313087|NCT03194490|BG001|Baseline|The Standard Intervention|"The standard intervention: The standard intervention group received cervical mobilization and home program (ROM exercises).~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral."
11313088|NCT03194490|BG002|Baseline|Total|Total of all reporting groups
11313089|NCT03194490|FG000|Participant Flow|Combined Intervention Group|"The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).~Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques were selected by the physical therapist based on the participant's condition.~Stretching exercise will be given to the participants by the physical therapist. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor muscles and interspinous muscles."
11313090|NCT03194490|FG001|Participant Flow|The Standard Intervention|"The standard intervention group will receive cervical mobilization and home program (ROM exercises).~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral."
11313091|NCT03194490|OG000|Outcome|Combined Intervention Group|"The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).~Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques were selected by the physical therapist based on the participant's condition.~Stretching exercise will be given to the participants by the physical therapist. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor muscles and interspinous muscles."
11313092|NCT03194490|OG001|Outcome|The Standard Intervention|"The standard intervention group will receive cervical mobilization and home program (ROM exercises).~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral."
11313093|NCT03194490|OG001|Outcome|The Standard Intervention|"The standard intervention group will receive cervical mobilization and home program (ROM exercises).~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral"
11313094|NCT03194490|EG000|Reported Event|The Combined Intervention Group|"The combined intervention group: The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).~Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques were selected by the physical therapist based on the participant's condition.~Stretching exercise will be given to the participants by the physical therapist. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: an"
11313095|NCT03194490|EG001|Reported Event|The Standard Intervention|"The standard intervention: The standard intervention group received cervical mobilization and home program (ROM exercises).~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as f"
11313096|NCT03194503|BG000|Baseline|Pre-Intervention|Intubations before VL coaching using train-the-trainer mechanism was implemented.
11313097|NCT03194503|BG001|Baseline|Post-Intervention|Intubations after VL coaching using train-the-trainer mechanism was implemented.
11313098|NCT03194503|BG002|Baseline|Total|Total of all reporting groups
11313099|NCT03194503|FG000|Participant Flow|Pre-Intervention|Intubations before VL coaching using train-the-trainer mechanism was implemented.
11313100|NCT03194503|FG001|Participant Flow|Post- Intervention|Intubations after VL coaching using train-the-trainer mechanism was implemented.
11313101|NCT03194503|OG000|Outcome|Pre-Intervention|Intubations before VL coaching using train-the-trainer mechanism was implemented.
11313102|NCT03194503|OG001|Outcome|Post-Intervention|Intubations after VL coaching using train-the-trainer mechanism was implemented.
11313103|NCT03194503|OG000|Outcome|VL Coaching|Intubations where the intubator (trainee) was coached by an attending to use Video Laryngoscopy.
11313104|NCT03194503|OG001|Outcome|No VL Coaching (Including DL&VL)|Intubations where the intubator was not coached to use Video Laryngoscopy or direct laryngoscopy was used.
11313105|NCT03194503|EG000|Reported Event|Pre-Intervention|Intubations before VL coaching using train-the-trainer mechanism was implemented..
11313106|NCT03194503|EG001|Reported Event|Post-Intervention|Intubations after VL coaching using train-the-trainer mechanism was implemented.
11313107|NCT03194698|BG000|Baseline|MGX and Intense Pulsed Light Treatment (IPL)|"Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)~Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313108|NCT03194698|BG001|Baseline|Meibomian Gland Expression (MGX)|"Treatment with 4 visits and 4 treatments of MGX only~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313109|NCT03194698|BG002|Baseline|Total|Total of all reporting groups
11313110|NCT03194698|FG000|Participant Flow|MGX and Intense Pulsed Light Treatment (IPL)|"Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)~Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
10975157|NCT00934141|FG003|Participant Flow|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
10975158|NCT00934141|OG000|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
10975159|NCT00934141|OG001|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
10975160|NCT00934141|OG002|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
10975161|NCT00934141|OG003|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
10975162|NCT00934141|OG002|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
10975163|NCT00934141|OG003|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
10975164|NCT00934141|EG000|Reported Event|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
10975165|NCT00934141|EG001|Reported Event|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
10975166|NCT00934141|EG002|Reported Event|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
10975167|NCT00934141|EG003|Reported Event|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
10975168|NCT00934362|BG000|Baseline|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
10975169|NCT00934362|BG001|Baseline|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
10975170|NCT00934362|BG002|Baseline|Total|Total of all reporting groups
10975171|NCT00934362|FG000|Participant Flow|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
11313111|NCT03194698|FG001|Participant Flow|Meibomian Gland Expression (MGX)|"Treatment with 4 visits and 4 treatments of MGX only~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
10975172|NCT00934362|FG001|Participant Flow|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
10975173|NCT00934362|OG000|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
10975174|NCT00934362|OG001|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
10975175|NCT00934362|EG000|Reported Event|Lucinactant|20 mg/ml x 6 ml (5 doses)
10975176|NCT00934362|EG001|Reported Event|Placebo|0.9% NaCl x 6 ml (5 doses)
10975177|NCT00934375|BG000|Baseline|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
10975178|NCT00934375|BG001|Baseline|Placebo|
10975179|NCT00934375|BG002|Baseline|Total|Total of all reporting groups
10975180|NCT00934375|FG000|Participant Flow|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
10975181|NCT00934375|FG001|Participant Flow|Placebo|
10975182|NCT00934375|OG000|Outcome|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
10975183|NCT00934375|OG001|Outcome|Placebo|
10975184|NCT00934375|EG000|Reported Event|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
10975185|NCT00934375|EG001|Reported Event|Placebo|
11313112|NCT03194698|OG000|Outcome|MGX and Intense Pulsed Light Treatment (IPL)|"Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)~Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313113|NCT03194698|OG001|Outcome|Meibomian Gland Expression (MGX)|"Treatment with 4 visits and 4 treatments of MGX only~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313114|NCT03194698|EG000|Reported Event|MGX and Intense Pulsed Light Treatment (IPL)|"Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)~Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313115|NCT03194698|EG001|Reported Event|Meibomian Gland Expression (MGX)|"Treatment with 4 visits and 4 treatments of MGX only~Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye."
11313116|NCT03194737|BG000|Baseline|UroLift System Procedure|"All eligible,enroled subjects will undergo a UroLift procedure.~UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH."
11313117|NCT03194737|BG001|Baseline|Retrospective Arm|Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015
11313118|NCT03194737|BG002|Baseline|Total|Total of all reporting groups
11313119|NCT03194737|FG000|Participant Flow|UroLift System Procedure|"All eligible,enroled subjects will undergo a UroLift procedure.~UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH."
11313120|NCT03194737|FG001|Participant Flow|Retrospective Arm|Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015
11313121|NCT03194737|OG000|Outcome|UroLift System Procedure|"All eligible, enrolled subjects will undergo a UroLift procedure.~UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH."
10975186|NCT00934440|BG000|Baseline|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
11313122|NCT03194737|OG001|Outcome|Retrospective Arm|Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015
11313123|NCT03194737|EG000|Reported Event|UroLift System Procedure|"All eligible,enroled subjects will undergo a UroLift procedure.~UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH."
11313124|NCT03194737|EG001|Reported Event|Retrospective Arm|Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015
11313125|NCT03194776|BG000|Baseline|LLG783 6mg/kg|Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313126|NCT03194776|BG001|Baseline|Placebo|Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313127|NCT03194776|BG002|Baseline|Total|Total of all reporting groups
11313128|NCT03194776|FG000|Participant Flow|LLG783 6mg/kg|Participants received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313129|NCT03194776|FG001|Participant Flow|Placebo|Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313130|NCT03194776|OG000|Outcome|LLG783 6mg/kg|Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313131|NCT03194776|OG001|Outcome|Placebo|Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313132|NCT03194776|OG000|Outcome|LLG783 6 mg/kg|Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313133|NCT03194776|EG000|Reported Event|LLG783 i.v. 6 mg/kg|Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313134|NCT03194776|EG001|Reported Event|Placebo|Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
11313135|NCT03195010|BG000|Baseline|Group I (Lower Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo lower dose platelet transfusion"
11313136|NCT03195010|BG001|Baseline|Group II (Higher Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo higher dose platelet transfusion"
11313137|NCT03195010|BG002|Baseline|Total|Total of all reporting groups
10975187|NCT00934440|FG000|Participant Flow|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
10975188|NCT00934440|OG000|Outcome|5-Azacitidine Maximum Tolerated Dose (MTD)|
10975189|NCT00934440|OG000|Outcome|Dose Escalation: 5-azacitidine|"A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.~Bevacizumab:~First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1~Second treatment: 10 MG/KG IV on Day 1~Third and subsequent treatments: 10 MG/KG IV on Day 1"
10975190|NCT00934440|EG000|Reported Event|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
10975191|NCT00934544|BG000|Baseline|Ruxolitinib|5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
10975192|NCT00934544|BG001|Baseline|Best Available Therapy (BAT)|Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
10975193|NCT00934544|BG002|Baseline|Total|Total of all reporting groups
10975194|NCT00934544|FG000|Participant Flow|Ruxolitinib|5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
10975195|NCT00934544|FG001|Participant Flow|Best Available Therapy (BAT)|Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
10975196|NCT00934544|FG002|Participant Flow|Ruxolitinib After BAT (Cross-over)|5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
10975197|NCT00934544|OG000|Outcome|Ruxolitinib|5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
10975198|NCT00934544|OG001|Outcome|Best Available Therapy (BAT)|Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
10975199|NCT00934544|OG001|Outcome|Ruxolitinib - Grade 1|
10975200|NCT00934544|OG002|Outcome|Ruxolitinib - Grade 2|
10975201|NCT00934544|OG003|Outcome|Ruxolitinib - Grade 3|
10975202|NCT00934544|OG004|Outcome|Ruxolitinib - Missing|
10975203|NCT00934544|OG005|Outcome|Best Available Therapy (BAT) - Grade 0|
10975204|NCT00934544|OG006|Outcome|Best Available Therapy (BAT) - Grade 1|
10975205|NCT00934544|OG007|Outcome|Best Available Therapy (BAT) - Grade 2|
10975206|NCT00934544|OG008|Outcome|Best Available Therapy (BAT) - Grade 3|
10975207|NCT00934544|OG009|Outcome|Best Available Therapy - Missing|
10975208|NCT00934544|EG000|Reported Event|Ruxolitinib Randomized|Ruxolitinib Randomized
10975209|NCT00934544|EG001|Reported Event|Ruxolitinib Randomized + Extension Phase|Ruxolitinib Randomized + Extension Phase
10975210|NCT00934544|EG002|Reported Event|BAT Randomized|BAT Randomized
10975211|NCT00934544|EG003|Reported Event|Ruxolitinib Cross-over|Ruxolitinib cross-over
10975212|NCT00934596|BG000|Baseline|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. Hereafter the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart defibrillated. After a good cardiac contraction and normal central hemodynamics were established, the LV preload was gradually and successively increased. When no air emboli were observed in the left side of the heart by transesophageal echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
10975213|NCT00934596|BG001|Baseline|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before cannulation, CO2 was insufflated in the mediastinum at a flow rate of 10 litres/minute and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively re-filled with blood and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under transesophageal echocardiographic (TEE) monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to eject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
10975214|NCT00934596|BG002|Baseline|Total|Total of all reporting groups
11313138|NCT03195010|FG000|Participant Flow|Group I (Lower Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo lower dose platelet transfusion"
11313139|NCT03195010|FG001|Participant Flow|Group II (Higher Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo higher dose platelet transfusion"
11313140|NCT03195010|OG000|Outcome|Approached Patients|Eligible patients approached for participation
11313141|NCT03195010|OG000|Outcome|Screened Patients|Patients screened for eligibility
11313142|NCT03195010|OG000|Outcome|Group I (Lower Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo lower dose platelet transfusion"
10975215|NCT00934596|FG000|Participant Flow|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart by Trans-esophageal Echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
10975216|NCT00934596|FG001|Participant Flow|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the carbon-dioxide(CO2) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
10975217|NCT00934596|OG000|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
10975218|NCT00934596|OG001|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
10975219|NCT00934596|OG000|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
10975220|NCT00934596|OG001|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
10975221|NCT00934596|OG000|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
11313143|NCT03195010|OG001|Outcome|Group II (Higher Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo higher dose platelet transfusion"
10826462|NCT00103662|EG000|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826463|NCT00103662|EG001|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
10826464|NCT00103740|BG000|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826465|NCT00103740|BG001|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826466|NCT00103740|BG002|Baseline|Total|Total of all reporting groups
10826467|NCT00103740|FG000|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826468|NCT00103740|FG001|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826469|NCT00103740|OG000|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826470|NCT00103740|OG001|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826471|NCT00103740|EG000|Reported Event|Zoledronic Acid|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826472|NCT00103740|EG001|Reported Event|Risedronate|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
10826473|NCT00103844|BG000|Baseline|Dasatinib|Dasatinib 70 mg twice a day (BID)
10826474|NCT00103844|BG001|Baseline|Imatinib|Imatinib 400 mg BID
10826475|NCT00103844|BG002|Baseline|Total|Total of all reporting groups
10826476|NCT00103844|FG000|Participant Flow|Dasatinib First|Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
10826477|NCT00103844|FG001|Participant Flow|Imatinib First|Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
10826478|NCT00103844|OG000|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
10826479|NCT00103844|OG001|Outcome|Imatinib|Imatinib 400 mg BID
10826480|NCT00103844|EG000|Reported Event|DASATINIB|Dasatinib 70 mg twice a day (BID)
10826481|NCT00103844|EG001|Reported Event|IMATINIB|Imatinib 400 mg BID
10826482|NCT00103857|BG000|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
10826483|NCT00103857|BG001|Baseline|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10848556|NCT00290433|BG000|Baseline|HCVIDDOXIL Regimen|"Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.~Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3."
10975222|NCT00934596|OG001|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
10975223|NCT00934596|EG000|Reported Event|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
10975224|NCT00934596|EG001|Reported Event|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
10975225|NCT00934622|BG000|Baseline|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
10975226|NCT00934622|FG000|Participant Flow|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
10975227|NCT00934622|OG000|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
10975228|NCT00934622|EG000|Reported Event|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
10975229|NCT00934635|BG000|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975230|NCT00934635|BG001|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
11313144|NCT03195010|EG000|Reported Event|Group I (Lower Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo lower dose platelet transfusion"
10975231|NCT00934635|BG002|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975232|NCT00934635|BG003|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
10975233|NCT00934635|BG004|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
10975234|NCT00934635|BG005|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
10975235|NCT00934635|BG006|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975236|NCT00934635|BG007|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975237|NCT00934635|BG008|Baseline|Control|PET Scan Control
10975238|NCT00934635|BG009|Baseline|Total|Total of all reporting groups
10975239|NCT00934635|FG000|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975240|NCT00934635|FG001|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975241|NCT00934635|FG002|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975242|NCT00934635|FG003|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
10975243|NCT00934635|FG004|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
10975244|NCT00934635|FG005|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
10975245|NCT00934635|FG006|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975246|NCT00934635|FG007|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975247|NCT00934635|FG008|Participant Flow|Control|PET Scan Control
10975248|NCT00934635|OG000|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975249|NCT00934635|OG001|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975250|NCT00934635|OG002|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975251|NCT00934635|OG003|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
10975252|NCT00934635|OG004|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
10975253|NCT00934635|OG005|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
10975254|NCT00934635|OG006|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975255|NCT00934635|OG007|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975256|NCT00934635|OG008|Outcome|Control|PET Scan Control
10975257|NCT00934635|EG000|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975258|NCT00934635|EG001|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975259|NCT00934635|EG002|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
10975260|NCT00934635|EG003|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
10975261|NCT00934635|EG004|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
10975262|NCT00934635|EG005|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
10975263|NCT00934635|EG006|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975264|NCT00934635|EG007|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
10975265|NCT00934635|EG008|Reported Event|Control|PET Scan Control
10975266|NCT00934648|BG000|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
10975267|NCT00934648|FG000|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
10975268|NCT00934648|OG000|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
10975269|NCT00934648|EG000|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
10975270|NCT00934661|BG000|Baseline|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
10975271|NCT00934661|BG001|Baseline|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
10975272|NCT00934661|BG002|Baseline|Total|Total of all reporting groups
10975273|NCT00934661|FG000|Participant Flow|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
10975274|NCT00934661|FG001|Participant Flow|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
10975275|NCT00934661|OG000|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
10975276|NCT00934661|OG001|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
10975277|NCT00934661|EG000|Reported Event|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
10826484|NCT00103857|BG002|Baseline|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826485|NCT00103857|BG003|Baseline|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826486|NCT00103857|BG004|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826487|NCT00103857|BG005|Baseline|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
10826488|NCT00103857|BG006|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
10826489|NCT00103857|BG007|Baseline|Total|Total of all reporting groups
10826490|NCT00103857|FG000|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
10826491|NCT00103857|FG001|Participant Flow|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826492|NCT00103857|FG002|Participant Flow|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826493|NCT00103857|FG003|Participant Flow|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10975278|NCT00934661|EG001|Reported Event|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
10975279|NCT00934843|BG000|Baseline|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
10975280|NCT00934843|BG001|Baseline|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
10975281|NCT00934843|BG002|Baseline|Total|Total of all reporting groups
10975282|NCT00934843|FG000|Participant Flow|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
10975283|NCT00934843|FG001|Participant Flow|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
10975284|NCT00934843|OG000|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
10975285|NCT00934843|OG001|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
10975286|NCT00934843|EG000|Reported Event|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
10975287|NCT00934843|EG001|Reported Event|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
10975288|NCT00934856|BG000|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975289|NCT00934856|BG001|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975290|NCT00934856|BG002|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975291|NCT00934856|BG003|Baseline|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975292|NCT00934856|BG004|Baseline|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975293|NCT00934856|BG005|Baseline|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975294|NCT00934856|BG006|Baseline|Total|Total of all reporting groups
10975295|NCT00934856|FG000|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC received docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and trastuzumab emtansine (T-DM1) 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975296|NCT00934856|FG001|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975297|NCT00934856|FG002|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10826494|NCT00103857|FG004|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826495|NCT00103857|FG005|Participant Flow|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
10826496|NCT00103857|FG006|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
10826497|NCT00103857|OG000|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
10826498|NCT00103857|OG001|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826499|NCT00103857|OG002|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826500|NCT00103857|OG003|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826501|NCT00103857|OG004|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826502|NCT00103857|OG005|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
10826503|NCT00103857|EG000|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
10826504|NCT00103857|EG001|Reported Event|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826505|NCT00103857|EG002|Reported Event|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826506|NCT00103857|EG003|Reported Event|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826507|NCT00103857|EG004|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10826508|NCT00103857|EG005|Reported Event|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
10826509|NCT00103857|EG006|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
10826510|NCT00104052|BG000|Baseline|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
10826511|NCT00104052|FG000|Participant Flow|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
10826512|NCT00104052|OG000|Outcome|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
10826513|NCT00104052|EG000|Reported Event|PEG-Intron Plus REBETOL|
11313145|NCT03195010|EG001|Reported Event|Group II (Higher Dose Platelet Transfusion)|"Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.~Platelet Transfusion: Undergo higher dose platelet transfusion"
10826514|NCT00104104|BG000|Baseline|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
10826515|NCT00104104|BG001|Baseline|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
10826516|NCT00104104|BG002|Baseline|Total|Total of all reporting groups
10826517|NCT00104104|FG000|Participant Flow|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
10826518|NCT00104104|FG001|Participant Flow|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
10826519|NCT00104104|OG000|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
10826520|NCT00104104|OG001|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
10826521|NCT00104104|EG000|Reported Event|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
10826522|NCT00104104|EG001|Reported Event|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
10826523|NCT00104234|BG000|Baseline|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
10826524|NCT00104234|BG001|Baseline|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
10826525|NCT00104234|BG002|Baseline|Total|Total of all reporting groups
10826526|NCT00104234|FG000|Participant Flow|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
10826527|NCT00104234|FG001|Participant Flow|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
10826528|NCT00104234|OG000|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
10826529|NCT00104234|OG001|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
10826530|NCT00104234|OG000|Outcome|All Participants (N=37)|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
10826531|NCT00104234|EG000|Reported Event|All Participants|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
10826532|NCT00104247|BG000|Baseline|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
10826533|NCT00104247|BG001|Baseline|Placebo|Placebo
10826534|NCT00104247|BG002|Baseline|Total|Total of all reporting groups
10826535|NCT00104247|FG000|Participant Flow|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
10826536|NCT00104247|FG001|Participant Flow|Placebo|Placebo
10826537|NCT00104247|OG000|Outcome|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
10826538|NCT00104247|OG001|Outcome|Placebo|Placebo
10826539|NCT00104247|EG000|Reported Event|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
10826540|NCT00104247|EG001|Reported Event|Placebo|Placebo
10826541|NCT00104299|BG000|Baseline|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
10826542|NCT00104299|BG001|Baseline|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
10826543|NCT00104299|BG002|Baseline|Total|Total of all reporting groups
10826544|NCT00104299|FG000|Participant Flow|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
10826545|NCT00104299|FG001|Participant Flow|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
10826546|NCT00104299|OG000|Outcome|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
10826547|NCT00104299|OG001|Outcome|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
10975298|NCT00934856|FG003|Participant Flow|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975299|NCT00934856|FG004|Participant Flow|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975300|NCT00934856|FG005|Participant Flow|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975301|NCT00934856|OG000|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975302|NCT00934856|OG001|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975303|NCT00934856|OG002|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975304|NCT00934856|OG003|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975305|NCT00934856|OG004|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975306|NCT00934856|OG005|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975307|NCT00934856|OG000|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975308|NCT00934856|OG001|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975309|NCT00934856|OG002|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975310|NCT00934856|OG003|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975311|NCT00934856|OG004|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975312|NCT00934856|OG005|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975313|NCT00934856|OG000|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
10975314|NCT00934856|OG000|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
11313146|NCT03195517|BG000|Baseline|Control/Exercise Training|33 osteopenic postmenopausal women were included in the study. Bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment, after 1 month run-in and after 3 months of high-impact exercise training.
11313147|NCT03195517|FG000|Participant Flow|Control/Exercise Training|"At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in.~All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training."
11313148|NCT03195517|OG000|Outcome|No Additional Physical Exercise|Usual recommendations for prevention of fractures in adults and elderly.
11313149|NCT03195517|OG000|Outcome|Physical Exercise|"The exercise program was performed at C.U.R.I.A.Mo. Institute of Università degli Studi di Perugia. Twenty-four exercise sessions were provided, carried out twice a week for three months. Each session was supervised by two graduated trainers and two medical doctors with a maximum attendance of 5 patient/group.~Each session lasted 45 minutes divided into 15 minutes of aerobic activity and 30 minutes of weight-bearing and resistance activities.~This latter section was specifically projected for adults and older adults with increased risk of fractures and was intended to improve muscle strength and flexibility, balance and, as a result, to prevent the risk of falls.~Physical exercise"
11313150|NCT03195517|OG000|Outcome|Control/Exercise Training|Usual care and no additional physical exercise
11313151|NCT03195517|OG000|Outcome|Control/Exercise Training|"The exercise program was performed at C.U.R.I.A.Mo. Healthy Lifestyle Institute of Perugia University.~The program provided 24 exercise sessions supervised by 2 physical education instructors and 2 medical researchers with a maximum attendance of 5 patient/group and carried out twice a week for three months.~Each session lasted approximately 45 minutes divided into 15 minutes of cardiovascular activity performed using various ergometers and 30 minutes of weight-bearing endurance activities, resistance training and other exercise to develop balance and prevent falls, organized according to circuit training methodology.~The great part of the exercise included in the program aim to provide variably strains (compression, bending, twisting) distributed across an higher surface of the femoral neck, to produce a maximal osteogenic response."
11313152|NCT03195517|OG000|Outcome|Control/Exercise Training|"At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in.~All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training."
11313153|NCT03195517|EG000|Reported Event|Control/Exercise Training|"At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in.~All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training."
11313154|NCT03196076|BG000|Baseline|Perflutren Lipid Microsphere (Healthy Subjects)|"Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313155|NCT03196076|BG001|Baseline|Perflutren Lipid Microsphere (Patients With Kidney Lesions)|"Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313156|NCT03196076|BG002|Baseline|Controls: No Interaction|Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
11313157|NCT03196076|BG003|Baseline|Total|Total of all reporting groups
11333318|NCT03512028|BG001|Baseline|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-8.~Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333319|NCT03512028|BG002|Baseline|Total|Total of all reporting groups
10826548|NCT00104299|EG000|Reported Event|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
11313158|NCT03196076|FG000|Participant Flow|Perflutren Lipid Microsphere (Healthy Subjects)|"Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313159|NCT03196076|FG001|Participant Flow|Perflutren Lipid Microsphere (Patients With Kidney Lesions)|"Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313160|NCT03196076|FG002|Participant Flow|Controls: No Interaction|Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
11313161|NCT03196076|OG000|Outcome|Perflutren Lipid Microsphere (Healthy Subjects)|"Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
10826549|NCT00104299|EG001|Reported Event|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
10826550|NCT00104416|BG000|Baseline|Double-Blind Phase: Placebo|Control - matching placebo once daily
10826551|NCT00104416|BG001|Baseline|Double-Blind Phase: LTG XR|LTG XR once daily
10826552|NCT00104416|BG002|Baseline|Total|Total of all reporting groups
10826553|NCT00104416|FG000|Participant Flow|Double-Blind Phase: Placebo|Control - matching placebo once daily
10826554|NCT00104416|FG001|Participant Flow|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
10826555|NCT00104416|FG002|Participant Flow|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
10826556|NCT00104416|FG003|Participant Flow|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
10826557|NCT00104416|FG004|Participant Flow|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
10826558|NCT00104416|OG000|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
10826559|NCT00104416|OG001|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
10826560|NCT00104416|OG000|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
10826561|NCT00104416|OG001|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
10826562|NCT00104416|OG002|Outcome|Baseline Failures|Baseline failures who entered the CP
10826563|NCT00104416|EG000|Reported Event|Double-Blind Phase: Placebo|Control - matching placebo once daily
10826564|NCT00104416|EG001|Reported Event|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
10826565|NCT00104416|EG002|Reported Event|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
10826566|NCT00104416|EG003|Reported Event|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
10826567|NCT00104416|EG004|Reported Event|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
10826568|NCT00104520|BG000|Baseline|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10975315|NCT00934856|OG001|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975316|NCT00934856|OG000|Outcome|Overall MBC and LABC Participants|All enrolled participants who received at least one dose of study medication
10975317|NCT00934856|OG000|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
10975318|NCT00934856|OG001|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
10975319|NCT00934856|OG002|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
10975320|NCT00934856|OG000|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
11313162|NCT03196076|OG001|Outcome|Perflutren Lipid Microsphere (Patients With Kidney Lesions)|"Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313163|NCT03196076|OG002|Outcome|Controls: No Interaction|Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
11313164|NCT03196076|EG000|Reported Event|Perflutren Lipid Microsphere (Healthy Subjects)|"Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313165|NCT03196076|EG001|Reported Event|Perflutren Lipid Microsphere (Patients With Kidney Lesions)|"Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.~Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert."
11313166|NCT03196076|EG002|Reported Event|Controls: No Interaction|Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
10975321|NCT00934856|OG001|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
10975322|NCT00934856|OG002|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
10975323|NCT00934856|OG003|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
10975324|NCT00934856|OG004|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
10975325|NCT00934856|EG000|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975326|NCT00934856|EG001|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975327|NCT00934856|EG002|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975328|NCT00934856|EG003|Reported Event|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
10975329|NCT00934856|EG004|Reported Event|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10826569|NCT00104520|BG001|Baseline|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826570|NCT00104520|BG002|Baseline|Total|Total of all reporting groups
10826571|NCT00104520|FG000|Participant Flow|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826572|NCT00104520|FG001|Participant Flow|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826573|NCT00104520|OG000|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826574|NCT00104520|OG001|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826575|NCT00104520|EG000|Reported Event|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826576|NCT00104520|EG001|Reported Event|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
10826577|NCT00104572|BG000|Baseline|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826578|NCT00104572|BG001|Baseline|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826579|NCT00104572|BG002|Baseline|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826580|NCT00104572|BG003|Baseline|Total|Total of all reporting groups
10826581|NCT00104572|FG000|Participant Flow|Transdermal Testosterone|"13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826582|NCT00104572|FG001|Participant Flow|Aromatase Inhibitor|"13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826583|NCT00104572|FG002|Participant Flow|Placebo|"9 participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826584|NCT00104572|OG000|Outcome|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826585|NCT00104572|OG001|Outcome|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826586|NCT00104572|OG002|Outcome|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826587|NCT00104572|EG000|Reported Event|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826588|NCT00104572|EG001|Reported Event|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826589|NCT00104572|EG002|Reported Event|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
10826590|NCT00104637|BG000|Baseline|Randomized Participants|All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
10826591|NCT00104637|FG000|Participant Flow|Sildenafil /Placebo|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
10826592|NCT00104637|FG001|Participant Flow|Placebo /Sildenafil|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
10826593|NCT00104637|OG000|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
10826594|NCT00104637|OG001|Outcome|Placebo|Placebo by mouth three times a day.
10826595|NCT00104637|OG000|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
10826596|NCT00104637|OG000|Outcome|Sildenafil|Group that received Sildenafil
10826597|NCT00104637|OG001|Outcome|Placebo|Participants that received Placebo
10826598|NCT00104637|EG000|Reported Event|Sildenafil|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
10826599|NCT00104637|EG001|Reported Event|Placebo|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
10826600|NCT00104650|BG000|Baseline|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
10826601|NCT00104650|BG001|Baseline|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
10826602|NCT00104650|BG002|Baseline|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
10826603|NCT00104650|BG003|Baseline|Total|Total of all reporting groups
10826604|NCT00104650|FG000|Participant Flow|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
10826605|NCT00104650|FG001|Participant Flow|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
10826606|NCT00104650|FG002|Participant Flow|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
10826607|NCT00104650|OG000|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
10826608|NCT00104650|OG001|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
10826609|NCT00104650|OG002|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
10826610|NCT00104650|EG000|Reported Event|Bisphosphonate IV Q4W|
10826611|NCT00104650|EG001|Reported Event|Denosumab 180 mg Q12W|
10826612|NCT00104650|EG002|Reported Event|Denosumab 180 mg Q4W|
10826613|NCT00104858|BG000|Baseline|Treatment|"Patients receive fludarabine intravenously (IV) on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.~Patients undergo single fraction low-dose total-body irradiation (TBI) on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation (HSCT) on day 0.~Patients receive an immunosuppressive regimen comprising cyclosporine orally (PO) twice daily (BID) on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or three times daily (TID) on days 0-40 followed by a taper to day 96 (unrelated recipients)."
10826614|NCT00104858|FG000|Participant Flow|Treatment (Chemotherapy and Rituximab Followed by HCT)|"Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.~Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.~Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation:"
10826615|NCT00104858|OG000|Outcome|Treatment (Chemotherapy and Rituximab Followed by HCT)|"Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.~Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.~Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients)."
10826616|NCT00104858|OG000|Outcome|Treatment (Chemotherapy and Rituximab Followed by HCT)|"Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.~Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.~Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation:"
10826617|NCT00104858|OG001|Outcome|Treatment (Chemotherapy Followed by HCT)|"Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2.~Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0.~Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 100 followed by a taper to day 180. Patients also receive mycophenolate mofetil PO TID on days 0-40 followed by a taper to day 96.~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation:"
10848557|NCT00290433|FG000|Participant Flow|HCVIDDOXIL Regimen|"Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.~Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3."
10975330|NCT00934856|EG005|Reported Event|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
10975331|NCT00934934|BG000|Baseline|Placebo|"Saline will serve as the placebo solution since the active comparator is clear and colourless.~Normal Saline: Normal Saline"
10975332|NCT00934934|BG001|Baseline|Antifungal|"Patient will receive a dose daily for a total of 14 days~anidulafungin: TBA"
10975333|NCT00934934|BG002|Baseline|Total|Total of all reporting groups
10975334|NCT00934934|FG000|Participant Flow|Placebo|"Saline will serve as the placebo solution since the active comparator is clear and colourless.~Normal Saline: Normal Saline"
10975335|NCT00934934|FG001|Participant Flow|Antifungal|"Patient will receive a dose daily for a total of 14 days~anidulafungin: TBA"
10975336|NCT00934934|OG000|Outcome|Overall|
10975337|NCT00934934|OG000|Outcome|Placebo|
10975338|NCT00934934|OG001|Outcome|Antifungal|
10975339|NCT00934934|OG000|Outcome|VAP withCandida|
10975340|NCT00934934|OG001|Outcome|VAP Without Candida|
10975341|NCT00934934|EG000|Reported Event|Placebo|"Saline will serve as the placebo solution since the active comparator is clear and colourless.~Normal Saline: Normal Saline"
10975342|NCT00934934|EG001|Reported Event|Antifungal|"Patient will receive a dose daily for a total of 14 days~anidulafungin: TBA"
10975343|NCT00934947|BG000|Baseline|Sugar Pill|Identical to active drug in sight, taste, and smell.
10975344|NCT00934947|BG001|Baseline|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
10975345|NCT00934947|BG002|Baseline|Total|Total of all reporting groups
10975346|NCT00934947|FG000|Participant Flow|Sugar Pill|Identical to active drug in sight, taste, and smell.
10975347|NCT00934947|FG001|Participant Flow|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
10975348|NCT00934947|OG000|Outcome|Sugar Pill|Identical to active drug in sight, taste, and smell.
10975349|NCT00934947|OG001|Outcome|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
10975350|NCT00934947|OG000|Outcome|Propranolol|Individuals who were randomized to receive propranolol following an intention to treat analysis
10975351|NCT00934947|OG001|Outcome|Placebo|Individuals enrolled in the study who received placebo
10975352|NCT00934947|EG000|Reported Event|Sugar Pill|Identical to active drug in sight, taste, and smell.
10975353|NCT00934947|EG001|Reported Event|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
11092692|NCT01541384|OG001|Outcome|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092693|NCT01541384|OG002|Outcome|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
11092694|NCT01541384|EG000|Reported Event|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092695|NCT01541384|EG001|Reported Event|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.~Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
11092696|NCT01541384|EG002|Reported Event|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.~Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
11092697|NCT01541553|BG000|Baseline|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
11092698|NCT01541553|BG001|Baseline|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
11092699|NCT01541553|BG002|Baseline|Total|Total of all reporting groups
11092700|NCT01541553|FG000|Participant Flow|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
11092701|NCT01541553|FG001|Participant Flow|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
11092702|NCT01541553|OG000|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
11092703|NCT01541553|OG001|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
11092704|NCT01541553|EG000|Reported Event|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
11092705|NCT01541553|EG001|Reported Event|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
11092706|NCT01541644|BG000|Baseline|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
11092707|NCT01541644|FG000|Participant Flow|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
11092708|NCT01541644|OG000|Outcome|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
11092709|NCT01541644|EG000|Reported Event|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
11092710|NCT01541735|BG000|Baseline|Pantoprazole|The pantoprazole will be administered in 40mg capsules
11092711|NCT01541735|BG001|Baseline|Placebo|Placebo of calcined magnesia, capsules
11092712|NCT01541735|BG002|Baseline|Total|Total of all reporting groups
11092713|NCT01541735|FG000|Participant Flow|Pantoprazole|The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days
11092714|NCT01541735|FG001|Participant Flow|Placebo|Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
11092715|NCT01541735|OG000|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
11092716|NCT01541735|OG001|Outcome|Placebo|Placebo of calcined magnesia, capsules
11092717|NCT01541735|EG000|Reported Event|Pantoprazole|The pantoprazole will be administered in 40mg capsules
11092718|NCT01541735|EG001|Reported Event|Placebo|Placebo of calcined magnesia, capsules
11092719|NCT01541748|BG000|Baseline|AXIS Allograft Dermis|Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair.
11092720|NCT01541748|FG000|Participant Flow|Axis Allograft Dermis|Subjects with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments.
11092721|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair.
11092722|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair at 6 months
11092723|NCT01541748|OG000|Outcome|Axis Allograft Dermis|Participants with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments.
11092724|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior and/or posterior compartment.
11092725|NCT01541748|OG000|Outcome|Axis Allograft Dermis|Participants implanted with Axis Allograft Dermis who completed the PGI-I Questionnaire at 12 months.
11092726|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|"The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."
11092727|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Participants implanted with Axis Allograft Dermis
11092728|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair..
11092729|NCT01541748|OG000|Outcome|AXIS Allograft Dermis|Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
11092730|NCT01541748|OG000|Outcome|Axis Allograft Dermis|Subjects with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments.
11092731|NCT01541748|EG000|Reported Event|AXIS Allograft Dermis|Participants implanted with AXIS Allograft Dermis.
11092732|NCT01541826|BG000|Baseline|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
11092733|NCT01541826|BG001|Baseline|Chokeberry Extract Capsule|"Chokeberry extract capsule~Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks."
10826618|NCT00104858|EG000|Reported Event|Treatment|"Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38.~Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38.~Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients).~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Peripheral Blood Stem Cell Transplantation:"
10826619|NCT00104871|BG000|Baseline|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
10826620|NCT00104871|FG000|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
10826621|NCT00104871|OG000|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
10826622|NCT00104871|EG000|Reported Event|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
10826623|NCT00104884|BG000|Baseline|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
10826624|NCT00104884|FG000|Participant Flow|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
10826625|NCT00104884|OG000|Outcome|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
10826626|NCT00104884|EG000|Reported Event|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
10826627|NCT00105001|BG000|Baseline|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826628|NCT00105001|BG001|Baseline|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826629|NCT00105001|BG002|Baseline|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
10826630|NCT00105001|BG003|Baseline|Total|Total of all reporting groups
10826631|NCT00105001|FG000|Participant Flow|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826632|NCT00105001|FG001|Participant Flow|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826633|NCT00105001|FG002|Participant Flow|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and Mycophenolate Mofetil [MMF] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
11092734|NCT01541826|BG002|Baseline|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
11092735|NCT01541826|BG003|Baseline|Total|Total of all reporting groups
11092736|NCT01541826|FG000|Participant Flow|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
11092737|NCT01541826|FG001|Participant Flow|Chokeberry Extract Capsule|"Chokeberry extract capsule~Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.~Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose."
11092738|NCT01541826|FG002|Participant Flow|Chaokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
11092739|NCT01541826|OG000|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
11092740|NCT01541826|OG001|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
11092741|NCT01541826|OG000|Outcome|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
11092742|NCT01541826|EG000|Reported Event|Color-matched Rice Powder Pill|"Color-matched rice powder pill~Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
11092743|NCT01541826|EG001|Reported Event|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
11092744|NCT01541826|EG002|Reported Event|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
11313167|NCT03196193|BG000|Baseline|ZNN CM Asia With AS2 Technique|"Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.~Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.~Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw."
11092745|NCT01541865|BG000|Baseline|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
11092746|NCT01541865|FG000|Participant Flow|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
11092747|NCT01541865|OG000|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
11092748|NCT01541865|EG000|Reported Event|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
11092749|NCT01541891|BG000|Baseline|Arm A PRO 148 Ophthalmic Solution|PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
11092750|NCT01541891|BG001|Baseline|Arm B. SYSTANE® Ophthalmic Solution|Active Comparator: SYSTANE ® Ophthalmic Solution : Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
11092751|NCT01541891|BG002|Baseline|Total|Total of all reporting groups
11092752|NCT01541891|FG000|Participant Flow|Arm A PRO 148 Ophthalmic Solution|PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
11092753|NCT01541891|FG001|Participant Flow|Arm B. SYSTANE® Ophthalmic Solution|Active Comparator: SYSTANE ® Ophthalmic Solution : Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
11092754|NCT01541891|OG000|Outcome|Arm A PRO 148 Ophthalmic Solution|PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
11092755|NCT01541891|OG001|Outcome|Arm B. SYSTANE® Ophthalmic Solution|Active Comparator: SYSTANE ® Ophthalmic Solution : Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
11092756|NCT01541891|OG000|Outcome|PRO-148|"Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome~PRO-148 Ophthalmic Solution: PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days."
11092757|NCT01541891|OG001|Outcome|Arm B. SYSTANE® Ophthalmic Solution|Active Comparator: SYSTANE ® Ophthalmic Solution: Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
11092758|NCT01541891|EG000|Reported Event|Arm A PRO 148 Ophthalmic Solution|PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
11092759|NCT01541891|EG001|Reported Event|Arm B. SYSTANE® Ophthalmic Solution|Active Comparator: SYSTANE ® Ophthalmic Solution : Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
11092760|NCT01541917|BG000|Baseline|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.
11092761|NCT01541917|BG001|Baseline|Online Disease Education Control|The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.
11092762|NCT01541917|BG002|Baseline|Never Randomized|This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.
11092763|NCT01541917|BG003|Baseline|Total|Total of all reporting groups
11092764|NCT01541917|FG000|Participant Flow|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
11092765|NCT01541917|FG001|Participant Flow|Online Disease Education Control|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
11092766|NCT01541917|OG000|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
11092767|NCT01541917|OG001|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
11092768|NCT01541917|OG000|Outcome|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
11092769|NCT01541917|OG001|Outcome|Online Disease Education|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
11092770|NCT01541917|OG001|Outcome|Online Disease Education|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
11092771|NCT01541917|EG000|Reported Event|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
11092772|NCT01541917|EG001|Reported Event|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
11092773|NCT01541930|BG000|Baseline|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
11092774|NCT01541930|FG000|Participant Flow|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
11092775|NCT01541930|OG000|Outcome|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
11092776|NCT01541930|OG000|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (Baseline)
11092777|NCT01541930|OG001|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
11092778|NCT01541930|OG002|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
11092779|NCT01541930|OG000|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
11092780|NCT01541930|OG002|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
11092781|NCT01541930|OG000|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Appearance score evaluated on Day 0 (baseline)
11092782|NCT01541930|OG001|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Appearance score evaluated on Day 7
11092783|NCT01541930|OG002|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Appearance score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
11092784|NCT01541930|OG000|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Pain evaluation on Day 0 (baseline) by Visual Analogue Scale (mm)
10826634|NCT00105001|OG000|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826635|NCT00105001|OG001|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826636|NCT00105001|OG002|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
10826637|NCT00105001|EG000|Reported Event|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826638|NCT00105001|EG001|Reported Event|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
10826639|NCT00105001|EG002|Reported Event|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
10826640|NCT00105027|BG000|Baseline|CRVO Observation|Standard care consists of observation of the macular edema.
10826641|NCT00105027|BG001|Baseline|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826642|NCT00105027|BG002|Baseline|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826643|NCT00105027|BG003|Baseline|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
10826644|NCT00105027|BG004|Baseline|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826645|NCT00105027|BG005|Baseline|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
11092785|NCT01541930|OG001|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Pain evaluation on Day 7 by Visual Analogue Scale (mm)
11092786|NCT01541930|OG002|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Pain evaluation on Day 14 by Visual Analogue Scale (mm) One patient was withdrawn on Day 7 by Subject's request
10826646|NCT00105027|BG006|Baseline|Total|Total of all reporting groups
10826647|NCT00105027|FG000|Participant Flow|CRVO Observation|Standard care consists of observation of the macular edema.
10826648|NCT00105027|FG001|Participant Flow|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826649|NCT00105027|FG002|Participant Flow|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826650|NCT00105027|FG003|Participant Flow|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
10826651|NCT00105027|FG004|Participant Flow|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826652|NCT00105027|FG005|Participant Flow|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826653|NCT00105027|OG000|Outcome|CRVO Observation|Standard care consists of observation of the macular edema.
10826654|NCT00105027|OG001|Outcome|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826655|NCT00105027|OG002|Outcome|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826656|NCT00105027|OG003|Outcome|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
10826657|NCT00105027|OG004|Outcome|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826658|NCT00105027|OG005|Outcome|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826659|NCT00105027|EG000|Reported Event|CRVO Observation|Standard care consists of observation of the macular edema.
10826660|NCT00105027|EG001|Reported Event|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826661|NCT00105027|EG002|Reported Event|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826662|NCT00105027|EG003|Reported Event|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
10826663|NCT00105027|EG004|Reported Event|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
11092787|NCT01541930|EG000|Reported Event|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
10826664|NCT00105027|EG005|Reported Event|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
10826665|NCT00105066|BG000|Baseline|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
11092788|NCT01541969|BG000|Baseline|CR Neuromodulation|see Protocol section for details
10826666|NCT00105066|BG001|Baseline|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
10826667|NCT00105066|BG002|Baseline|Total|Total of all reporting groups
11092789|NCT01541969|BG001|Baseline|Tinnitus Masking|see Protocol section for details
11092790|NCT01541969|BG002|Baseline|Total|Total of all reporting groups
11092791|NCT01541969|FG000|Participant Flow|CR Neuromodulation|"Acoustic Co-ordinated Reset (CR) Neuromodulation includes an ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-12 weeks) and for at least 4 hours daily (12-36 weeks)~The experimental arm received the intervention in a double-blind RCT (0-12 weeks), with the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they continued with the same experimental intervention."
11092792|NCT01541969|FG001|Participant Flow|Tinnitus Masking|"The active control group had the same ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-36 weeks).~The active comparator group received the intervention in a double-blind RCT (0-12 weeks). They received the same device as the treatment group but the sound stimulation was determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they received the verum experimental intervention."
11092793|NCT01541969|OG000|Outcome|CR Neuromodulation|see Protocol section for details
11092794|NCT01541969|OG001|Outcome|Tinnitus Masking|see Protocol section for details
11092795|NCT01541969|OG001|Outcome|Tinnitus Masking|see Protocol section for details.
11092796|NCT01541969|OG000|Outcome|CR Neuromodulation|The treatment group were unblinded at 12 weeks and then continued to receive the same experimental intervention. At 36 weeks, this group had therefore received active treatment (0-36 weeks).
11092797|NCT01541969|OG001|Outcome|Tinnitus Masking|The active comparator group were unblinded at 12 weeks and the device algorithm was reprogrammed in the same way as the experimental intervention. At 36 weeks, this group had therefore received a mixture of placebo (0-12 weeks) and active treatment (12-36 weeks).
11092798|NCT01541969|EG000|Reported Event|Acoustic CR Neuromodulation|see Protocol section for details
11092799|NCT01541969|EG001|Reported Event|Tinnitus Masking|see Protocol section for details
11092800|NCT01542034|BG000|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092801|NCT01542034|BG001|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092802|NCT01542034|BG002|Baseline|Total|Total of all reporting groups
11092803|NCT01542034|FG000|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092804|NCT01542034|FG001|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092805|NCT01542034|OG000|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092806|NCT01542034|OG001|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092807|NCT01542034|EG000|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092808|NCT01542034|EG001|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11092809|NCT01542125|BG000|Baseline|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
11092810|NCT01542125|BG001|Baseline|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
11092811|NCT01542125|BG002|Baseline|Total|Total of all reporting groups
11092812|NCT01542125|FG000|Participant Flow|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
11092813|NCT01542125|FG001|Participant Flow|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
11092814|NCT01542125|OG000|Outcome|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
11092815|NCT01542125|OG001|Outcome|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
11092816|NCT01542125|EG000|Reported Event|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
11092817|NCT01542125|EG001|Reported Event|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
10826668|NCT00105066|FG000|Participant Flow|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
10826669|NCT00105066|FG001|Participant Flow|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
10826670|NCT00105066|OG000|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
10826671|NCT00105066|OG001|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
10826672|NCT00105066|EG000|Reported Event|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
10826673|NCT00105066|EG001|Reported Event|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
10826674|NCT00105079|BG000|Baseline|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826675|NCT00105079|BG001|Baseline|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826676|NCT00105079|BG002|Baseline|Total|Total of all reporting groups
10826677|NCT00105079|FG000|Participant Flow|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826678|NCT00105079|FG001|Participant Flow|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826679|NCT00105079|OG000|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826680|NCT00105079|OG001|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826681|NCT00105079|EG000|Reported Event|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
10826682|NCT00105079|EG001|Reported Event|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
11092818|NCT01542229|BG000|Baseline|Arm 1: PE + TAU|"Prolonged Exposure Therapy +Treatment As Usual~PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual"
11092819|NCT01542229|BG001|Baseline|Arm 2: Usual Treament|"Treatment As Usual~Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling"
11092820|NCT01542229|BG002|Baseline|Total|Total of all reporting groups
10826683|NCT00105157|BG000|Baseline|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826684|NCT00105157|BG001|Baseline|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
10826685|NCT00105157|BG002|Baseline|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826686|NCT00105157|BG003|Baseline|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826687|NCT00105157|BG004|Baseline|Total|Total of all reporting groups
10826688|NCT00105157|FG000|Participant Flow|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826689|NCT00105157|FG001|Participant Flow|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
10826690|NCT00105157|FG002|Participant Flow|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826691|NCT00105157|FG003|Participant Flow|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826692|NCT00105157|OG000|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826693|NCT00105157|OG001|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
10826694|NCT00105157|OG002|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826695|NCT00105157|OG003|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826696|NCT00105157|EG000|Reported Event|MK0518|Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.
10826697|NCT00105157|EG001|Reported Event|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
10826698|NCT00105183|BG000|Baseline|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
10826699|NCT00105183|BG001|Baseline|Placebo|USP 0.9% sodium chloride solution
10826700|NCT00105183|BG002|Baseline|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
10826701|NCT00105183|BG003|Baseline|Total|Total of all reporting groups
10826702|NCT00105183|FG000|Participant Flow|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
10826703|NCT00105183|FG001|Participant Flow|Placebo|USP 0.9% sodium chloride solution
10826704|NCT00105183|FG002|Participant Flow|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
10826705|NCT00105183|OG000|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
10826706|NCT00105183|OG001|Outcome|Placebo|USP 0.9% sodium chloride solution
10826707|NCT00105183|OG002|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
10826708|NCT00105183|EG000|Reported Event|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
11092821|NCT01542229|FG000|Participant Flow|Arm 1: PE + TAU|"Prolonged Exposure Therapy +Treatment As Usual~PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual"
11092822|NCT01542229|FG001|Participant Flow|Arm 2: Usual Treament|"Treatment As Usual~Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling"
10826709|NCT00105183|EG001|Reported Event|Placebo|USP 0.9% sodium chloride solution
10826710|NCT00105183|EG002|Reported Event|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
10826711|NCT00105196|BG000|Baseline|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826712|NCT00105196|BG001|Baseline|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826713|NCT00105196|BG002|Baseline|Total|Total of all reporting groups
10826714|NCT00105196|FG000|Participant Flow|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826715|NCT00105196|FG001|Participant Flow|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826716|NCT00105196|OG000|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826717|NCT00105196|OG001|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
10826718|NCT00105196|EG000|Reported Event|Aripiprazole|
10826719|NCT00105196|EG001|Reported Event|Placebo|
10826720|NCT00105235|BG000|Baseline|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826721|NCT00105235|FG000|Participant Flow|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826722|NCT00105235|OG000|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
11092823|NCT01542229|OG000|Outcome|Arm 1: PE + TAU|"Prolonged Exposure Therapy +Treatment As Usual~PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual"
11092824|NCT01542229|OG001|Outcome|Arm 2: Usual Treament|"Treatment As Usual~Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling"
11092825|NCT01542229|OG001|Outcome|Arm 2: Usual Treatment|"Treatment As Usual~Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling"
11092826|NCT01542229|EG000|Reported Event|Arm 1: PE + TAU|"Prolonged Exposure Therapy +Treatment As Usual~PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual"
11092827|NCT01542229|EG001|Reported Event|Arm 2: Usual Treament|"Treatment As Usual~Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling"
11092828|NCT01542255|BG000|Baseline|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
11092829|NCT01542255|FG000|Participant Flow|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
11092830|NCT01542255|OG000|Outcome|Single Arm|
11092831|NCT01542255|OG000|Outcome|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
11092832|NCT01542255|EG000|Reported Event|Single Arm|all patients received cyclophosphamide, DTIC and vinblastine
11092833|NCT01542307|BG000|Baseline|Enrolled Subjects|Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
11092834|NCT01542307|FG000|Participant Flow|Oxygen-treated Migraine Attacks|Oxygen is inhaled for 30 minutes during a migraine attack
11092835|NCT01542307|FG001|Participant Flow|Medical Air-treated Migraine Attacks|Medical air is inhaled for 30 minutes during a migraine attack
11092836|NCT01542307|OG000|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
11092837|NCT01542307|OG001|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
11092838|NCT01542307|EG000|Reported Event|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
11092839|NCT01542307|EG001|Reported Event|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
11092840|NCT01542372|BG000|Baseline|Step I: SSRI/SSRN Treatment of PTSD|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
11092841|NCT01542372|FG000|Participant Flow|Medication Augmentation (Prazosin)|"In this arm, the patients were given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin.~Prazosin as first-line agent: Prazosin .5 to 2 mg"
11092842|NCT01542372|FG001|Participant Flow|CBT Augmentation|"In this arm, patients were given CBT to treat SSRI/SSRN-resistant PTSD.~Cognitive Behavioral Therapy for PTSD: This is a culturally sensitive CBT for the treatment of PTSD"
11092843|NCT01542372|OG000|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
11092844|NCT01542372|OG001|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
11092845|NCT01542372|EG000|Reported Event|Step I and Step 2|Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation.
11092846|NCT01542398|BG000|Baseline|Family-Focused Psychosocial Intervention|"Intervention Group~Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions"
11092847|NCT01542398|BG001|Baseline|Waiting List Control|
11092848|NCT01542398|BG002|Baseline|Total|Total of all reporting groups
11092849|NCT01542398|FG000|Participant Flow|Family-Focused Psychosocial Intervention|"Intervention Group~Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: An 8-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions"
11092850|NCT01542398|FG001|Participant Flow|Waiting List Control Group|Waiting List Control Group of Adolescents who received the intervention once it was shown to be effective for the Intervention Group
11092851|NCT01542398|OG000|Outcome|Family-Focused Psychosocial Intervention|"Intervention Group~Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: An 8-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions"
10826723|NCT00105235|OG000|Outcome|Withdrawal Never Started|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826724|NCT00105235|OG001|Outcome|Completed Withdrawal and Remains Off Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826725|NCT00105235|OG002|Outcome|Completed Withdrawal and Restarted Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826726|NCT00105235|OG003|Outcome|Discontinued Immunosuppression Withdrawal|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826727|NCT00105235|EG000|Reported Event|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
10826728|NCT00105443|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
10826729|NCT00105443|BG001|Baseline|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
10826730|NCT00105443|BG002|Baseline|Total|Total of all reporting groups
10826731|NCT00105443|FG000|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
10826732|NCT00105443|FG001|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
10826733|NCT00105443|FG002|Participant Flow|B1) Placebo - no Open Label Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section."
11313168|NCT03196193|BG001|Baseline|ZNN CM Asia Without AS2 Technique|"Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System."
11313169|NCT03196193|BG002|Baseline|Total|Total of all reporting groups
11313170|NCT03196193|FG000|Participant Flow|ZNN CM Asia With AS2 Technique|"Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.~Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.~Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw."
11313171|NCT03196193|FG001|Participant Flow|ZNN CM Asia Without AS2 Technique|"Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System."
11313172|NCT03196193|OG000|Outcome|ZNN CM Asia With AS2 Technique|"Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.~Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.~Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw."
11313173|NCT03196193|OG001|Outcome|ZNN CM Asia Without AS2 Technique|"Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System."
11313174|NCT03196193|EG000|Reported Event|ZNN CM Asia With AS2 Technique|"Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.~Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.~Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw."
11313175|NCT03196193|EG001|Reported Event|ZNN CM Asia Without AS2 Technique|"Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.~Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.~ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System."
11313176|NCT03196232|BG000|Baseline|Treatment (Epacadostat, Pembrolizumab)|"Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.~Epacadostat: Given PO~Pembrolizumab: Given IV"
10826734|NCT00105443|FG003|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section."
10826735|NCT00105443|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
10826736|NCT00105443|OG001|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
10826737|NCT00105443|EG000|Reported Event|Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)|Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
10826738|NCT00105443|EG001|Reported Event|Placebo Arm Double-Blind Phase (Interim Data Only)|"Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
10826739|NCT00105443|EG002|Reported Event|Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)|Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
10826740|NCT00105443|EG003|Reported Event|Placebo Arm, Complete Double-Blind Phase|"Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
11092852|NCT01542398|OG001|Outcome|Waiting List Control Group|Waiting List Control Group of Adolescents who received the intervention once it was shown to be effective for the Intervention Group
11092853|NCT01542398|OG000|Outcome|Family-Focused Psychosocial Intervention|"Intervention Group~Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions"
11092854|NCT01542398|OG001|Outcome|Waiting List Control|
11092855|NCT01542398|EG000|Reported Event|Intervention Group|
11092856|NCT01542398|EG001|Reported Event|Waiting List Control Group|
11092857|NCT01542502|BG000|Baseline|All Participants|Baseline measures for all study participants
11092858|NCT01542502|FG000|Participant Flow|Anakinra (First) Then Placebo (Second)|"Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days~Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection"
11092859|NCT01542502|FG001|Participant Flow|Placebo (First) Then Anakinra (Second)|"Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days~Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection"
11092860|NCT01542502|OG000|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
11092861|NCT01542502|OG001|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
11092862|NCT01542502|OG000|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra~Anakinra: Anakinra 100 mg daily subcutaneous injection"
11092863|NCT01542502|EG000|Reported Event|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
11092864|NCT01542502|EG001|Reported Event|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
11092865|NCT01542528|BG000|Baseline|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
11092866|NCT01542528|BG001|Baseline|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
11092867|NCT01542528|BG002|Baseline|Total|Total of all reporting groups
11092868|NCT01542528|FG000|Participant Flow|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
11092869|NCT01542528|FG001|Participant Flow|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
11092870|NCT01542528|OG000|Outcome|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
11092871|NCT01542528|OG001|Outcome|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
11092872|NCT01542528|EG000|Reported Event|IBBS|"Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).~IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions)."
11092873|NCT01542528|EG001|Reported Event|Treatment as Usual (TAU)|Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
11092874|NCT01542541|BG000|Baseline|Rifaximin|Rifaximin: 550mg BID for 2 days
11092875|NCT01542541|BG001|Baseline|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
11092876|NCT01542541|BG002|Baseline|Total|Total of all reporting groups
11092877|NCT01542541|FG000|Participant Flow|Rifaximin|Rifaximin: 550mg BID for 2 days
11092878|NCT01542541|FG001|Participant Flow|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
11092879|NCT01542541|OG000|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
11092880|NCT01542541|OG001|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
10826741|NCT00105443|EG004|Reported Event|Subjects Switching From Placebo to Sorafenib (Open Label Only)|Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
10826742|NCT00105469|BG000|Baseline|AzaSite|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
10826743|NCT00105469|BG001|Baseline|Tobramycin|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
10826744|NCT00105469|BG002|Baseline|Total|Total of all reporting groups
10826745|NCT00105469|FG000|Participant Flow|AzaSite|
10826746|NCT00105469|FG001|Participant Flow|Tobramycin|
10826747|NCT00105469|OG000|Outcome|AzaSite|
10826748|NCT00105469|OG001|Outcome|Tobramycin|
10826749|NCT00105469|EG000|Reported Event|AzaSite|
10826750|NCT00105469|EG001|Reported Event|Tobramycin|
10826751|NCT00105482|BG000|Baseline|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826752|NCT00105482|BG001|Baseline|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826753|NCT00105482|BG002|Baseline|Total|Total of all reporting groups
10826754|NCT00105482|FG000|Participant Flow|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826755|NCT00105482|FG001|Participant Flow|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826756|NCT00105482|OG000|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826757|NCT00105482|OG001|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826758|NCT00105482|EG000|Reported Event|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826759|NCT00105482|EG001|Reported Event|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
10826760|NCT00105508|BG000|Baseline|Sarizotan|Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
10826761|NCT00105508|BG001|Baseline|Placebo|Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
10826762|NCT00105508|BG002|Baseline|Total|Total of all reporting groups
10826763|NCT00105508|FG000|Participant Flow|Sarizotan|Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
10826764|NCT00105508|FG001|Participant Flow|Placebo|Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
10826765|NCT00105508|OG000|Outcome|Sarizotan|Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
11092881|NCT01542541|EG000|Reported Event|Rifaximin|Rifaximin: 550mg BID for 2 days
11092882|NCT01542541|EG001|Reported Event|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
11092883|NCT01542632|BG000|Baseline|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
11092884|NCT01542632|BG001|Baseline|Group 2 (DO:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
11092885|NCT01542632|BG002|Baseline|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
11092886|NCT01542632|BG003|Baseline|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092887|NCT01542632|BG004|Baseline|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092888|NCT01542632|BG005|Baseline|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
11092889|NCT01542632|BG006|Baseline|Total|Total of all reporting groups
11092890|NCT01542632|FG000|Participant Flow|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
11092891|NCT01542632|FG001|Participant Flow|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
11092892|NCT01542632|FG002|Participant Flow|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
11092893|NCT01542632|FG003|Participant Flow|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092894|NCT01542632|FG004|Participant Flow|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092895|NCT01542632|FG005|Participant Flow|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
11092896|NCT01542632|OG000|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
11092897|NCT01542632|OG001|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
11092898|NCT01542632|OG002|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.
11092899|NCT01542632|OG003|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092900|NCT01542632|OG004|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092901|NCT01542632|OG005|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
11092902|NCT01542632|OG000|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
11092903|NCT01542632|OG002|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
11092904|NCT01542632|OG005|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
11092905|NCT01542632|OG003|Outcome|Group 4 (D0:TDV,P D90:TDV,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092906|NCT01542632|OG005|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
11092907|NCT01542632|EG000|Reported Event|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
11092908|NCT01542632|EG001|Reported Event|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
11092909|NCT01542632|EG002|Reported Event|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
11092910|NCT01542632|EG003|Reported Event|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092911|NCT01542632|EG004|Reported Event|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
11092912|NCT01542632|EG005|Reported Event|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
11092913|NCT01542645|BG000|Baseline|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092914|NCT01542645|BG001|Baseline|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092915|NCT01542645|BG002|Baseline|Total|Total of all reporting groups
11092916|NCT01542645|FG000|Participant Flow|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092917|NCT01542645|FG001|Participant Flow|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092918|NCT01542645|OG000|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092919|NCT01542645|OG001|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092920|NCT01542645|OG000|Outcome|Methadone|"Long-acting opioid~Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours."
11092921|NCT01542645|OG001|Outcome|Fentanyl|"Shorter-acting opioid~Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours."
11092922|NCT01542645|OG000|Outcome|Methadone|
11092923|NCT01542645|OG001|Outcome|Fentanyl|
11092924|NCT01542645|EG000|Reported Event|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11092925|NCT01542645|EG001|Reported Event|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
11217700|NCT02315664|EG000|Reported Event|Immediate Intervention Group|"Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.~Education session, Fitbit Flex, and remote coaching by a PT: Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately."
11217701|NCT02315664|EG001|Reported Event|Delayed Intervention Group|"Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.~Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay."
11217702|NCT02315755|BG000|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
11217703|NCT02315755|FG000|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
11217704|NCT02315755|OG000|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
11217705|NCT02315755|EG000|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
11217706|NCT02315872|BG000|Baseline|ACTH|"The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.~ACTH: ACTH injections twice weekly for 28 weeks."
11217707|NCT02315872|BG001|Baseline|Placebo|"Placebo will be given subcutaneously twice weekly for 28 weeks.~Placebo: Placebo injections twice weekly for 28 weeks."
11217708|NCT02315872|BG002|Baseline|Total|Total of all reporting groups
11217709|NCT02315872|FG000|Participant Flow|ACTH|"The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.~ACTH: ACTH injections twice weekly for 28 weeks."
11092926|NCT01542684|BG000|Baseline|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
11092927|NCT01542684|FG000|Participant Flow|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~Granulocyte-macrophage colony-stimulating factor (GM-CSF) administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
11092928|NCT01542684|OG000|Outcome|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle will last at least 4 weeks~Azacytidine: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.~GM-CSF: 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days."
11092929|NCT01542684|EG000|Reported Event|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
11092930|NCT01542788|BG000|Baseline|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
11092931|NCT01542788|BG001|Baseline|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
11092932|NCT01542788|BG002|Baseline|Total|Total of all reporting groups
11092933|NCT01542788|FG000|Participant Flow|SOF+RBV|Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
11092934|NCT01542788|FG001|Participant Flow|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
11092935|NCT01542788|OG000|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
11092936|NCT01542788|OG001|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
11092937|NCT01542788|EG000|Reported Event|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
11092938|NCT01542788|EG001|Reported Event|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
11092939|NCT01542957|BG000|Baseline|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
11092940|NCT01542957|BG001|Baseline|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
11092941|NCT01542957|BG002|Baseline|Total|Total of all reporting groups
11092942|NCT01542957|FG000|Participant Flow|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
11092943|NCT01542957|FG001|Participant Flow|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
11092944|NCT01542957|OG000|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
11092945|NCT01542957|OG001|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
11092946|NCT01542957|EG000|Reported Event|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
11092947|NCT01542957|EG001|Reported Event|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
11092948|NCT01543074|BG000|Baseline|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
11217710|NCT02315872|FG001|Participant Flow|Placebo|"Placebo will be given subcutaneously twice weekly for 28 weeks.~Placebo: Placebo injections twice weekly for 28 weeks."
11092949|NCT01543074|BG001|Baseline|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
10826766|NCT00105508|OG001|Outcome|Placebo|Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
10826767|NCT00105508|EG000|Reported Event|Sarizotan|Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
10826768|NCT00105508|EG001|Reported Event|Placebo|Subjects received placebo matched to sarizotan orally twice daily for 24 weeks.
10826769|NCT00105521|BG000|Baseline|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
10826770|NCT00105521|BG001|Baseline|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
10826771|NCT00105521|BG002|Baseline|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
10826772|NCT00105521|BG003|Baseline|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
10826773|NCT00105521|BG004|Baseline|Total|Total of all reporting groups
10826774|NCT00105521|FG000|Participant Flow|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
10826775|NCT00105521|FG001|Participant Flow|Sarizotan 2 mg/Day|Participants received sarizotan 2 milligrams per day (mg/day) (given in 2 divided daily doses) up to Week 12.
10826776|NCT00105521|FG002|Participant Flow|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
10826777|NCT00105521|FG003|Participant Flow|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
10826778|NCT00105521|OG000|Outcome|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
10826779|NCT00105521|OG001|Outcome|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
10826780|NCT00105521|OG002|Outcome|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
10826781|NCT00105521|OG003|Outcome|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
10826782|NCT00105521|EG000|Reported Event|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
10826783|NCT00105521|EG001|Reported Event|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
10826784|NCT00105521|EG002|Reported Event|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
10826785|NCT00105521|EG003|Reported Event|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
10826786|NCT00105534|BG000|Baseline|AzaSite|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
10826787|NCT00105534|BG001|Baseline|Vehicle|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
10826788|NCT00105534|BG002|Baseline|Total|Total of all reporting groups
10826789|NCT00105534|FG000|Participant Flow|AzaSite|
10826790|NCT00105534|FG001|Participant Flow|Vehicle|
10826791|NCT00105534|OG000|Outcome|AzaSite|
10826792|NCT00105534|OG001|Outcome|Vehicle|
10826793|NCT00105534|EG000|Reported Event|AzaSite|
10826794|NCT00105534|EG001|Reported Event|Vehicle|
10826795|NCT00105586|BG000|Baseline|Placebo|Participants will receive a placebo.
10826796|NCT00105586|BG001|Baseline|Escitalopram|Participants will receive escitalopram.
10826797|NCT00105586|BG002|Baseline|Total|Total of all reporting groups
10826798|NCT00105586|FG000|Participant Flow|Placebo|Participants will receive a placebo.
10826799|NCT00105586|FG001|Participant Flow|Escitalopram|Participants will receive escitalopram.
10826800|NCT00105586|OG000|Outcome|Placebo|Participants will receive a placebo.
10826801|NCT00105586|OG001|Outcome|Escitalopram|Participants will receive escitalopram.
10826802|NCT00105586|OG000|Outcome|Escitalopram (1)|"Escitalopram~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
10826803|NCT00105586|OG001|Outcome|Placebo (2)|"Placebo~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
10826804|NCT00105586|EG000|Reported Event|Placebo|Participants will receive a placebo.
10826805|NCT00105586|EG001|Reported Event|Escitalopram|Participants will receive escitalopram.
10826806|NCT00105989|BG000|Baseline|Duloxetine|duloxetine 60-120 mg QD
10826807|NCT00105989|FG000|Participant Flow|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
10826808|NCT00105989|FG001|Participant Flow|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
10826809|NCT00105989|OG000|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
10826810|NCT00105989|OG001|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
10826811|NCT00105989|OG000|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
10826812|NCT00105989|OG001|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
10826813|NCT00105989|OG000|Outcome|Duloxetine - Acute|duloxetine 60-120 mg QD
10826814|NCT00105989|OG001|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg QD
10826815|NCT00105989|OG000|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
11092950|NCT01543074|BG002|Baseline|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
11092951|NCT01543074|BG003|Baseline|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092952|NCT01543074|BG004|Baseline|Total|Total of all reporting groups
11092953|NCT01543074|FG000|Participant Flow|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
11092954|NCT01543074|FG001|Participant Flow|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092955|NCT01543074|FG002|Participant Flow|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
11092956|NCT01543074|FG003|Participant Flow|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092957|NCT01543074|OG000|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
11092958|NCT01543074|OG001|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092959|NCT01543074|OG002|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
11092960|NCT01543074|OG003|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092961|NCT01543074|OG000|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
11092962|NCT01543074|OG001|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic oil: 1 pill = 30 mg garlic oil/day"
11092963|NCT01543074|OG002|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~BSE: 2 pills = 200 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
11092964|NCT01543074|OG003|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~Garlic oil: 1 pill = 30 mg garlic oil/day~BSE: 2 pills = 200 micromoles of Sulforaphane/day"
11092965|NCT01543074|EG000|Reported Event|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
11092966|NCT01543074|EG001|Reported Event|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092967|NCT01543074|EG002|Reported Event|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
11092968|NCT01543074|EG003|Reported Event|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
11092969|NCT01543087|BG000|Baseline|Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule)|Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.
11092970|NCT01543087|BG001|Baseline|Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092971|NCT01543087|BG002|Baseline|Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092972|NCT01543087|BG003|Baseline|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092973|NCT01543087|BG004|Baseline|Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092974|NCT01543087|BG005|Baseline|Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092975|NCT01543087|BG006|Baseline|Total|Total of all reporting groups
10826816|NCT00105989|OG000|Outcome|Duloxetine 60 mg|duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
11092976|NCT01543087|FG000|Participant Flow|Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule)|Participants received quadrivalent meningococcal polysaccharide conjugate (MCV4) tetanus + acellular pertussis (Tdap) +Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.
11092977|NCT01543087|FG001|Participant Flow|Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092978|NCT01543087|FG002|Participant Flow|Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092979|NCT01543087|FG003|Participant Flow|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092980|NCT01543087|FG004|Participant Flow|Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092981|NCT01543087|FG005|Participant Flow|Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092982|NCT01543087|OG000|Outcome|Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule)|Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.
11092983|NCT01543087|OG001|Outcome|Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
11092984|NCT01543087|OG002|Outcome|Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
11092985|NCT01543087|OG001|Outcome|Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092986|NCT01543087|OG002|Outcome|Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
11092987|NCT01543087|OG003|Outcome|Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
11092988|NCT01543087|OG004|Outcome|Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
11092989|NCT01543087|OG005|Outcome|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092990|NCT01543087|OG006|Outcome|Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092991|NCT01543087|OG007|Outcome|Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092992|NCT01543087|OG004|Outcome|Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of this study.
11092993|NCT01543087|OG000|Outcome|Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092994|NCT01543087|OG002|Outcome|Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
11092995|NCT01543087|OG003|Outcome|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092996|NCT01543087|OG004|Outcome|Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092997|NCT01543087|OG005|Outcome|Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11092998|NCT01543087|OG000|Outcome|Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
11092999|NCT01543087|OG001|Outcome|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093000|NCT01543087|OG001|Outcome|Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093001|NCT01543087|OG002|Outcome|Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093002|NCT01543087|OG003|Outcome|Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093003|NCT01543087|OG004|Outcome|Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093004|NCT01543087|OG002|Outcome|Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093005|NCT01543087|EG000|Reported Event|Stage1,Group 1:MCV4+Tdap+Saline (0-,2-,and 6-Month Schedule):|Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.
11093006|NCT01543087|EG001|Reported Event|Stage 1, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule):|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.
11093007|NCT01543087|EG002|Reported Event|Stage 1, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule):|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study.
11093008|NCT01543087|EG003|Reported Event|Stage 1, Group 4: rLP2086 (0-and 6-Month Schedule):|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.
11093009|NCT01543087|EG004|Reported Event|Stage 1, Group 5: rLP2086 (0- and 2-Month Schedule):|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.
11093010|NCT01543087|EG005|Reported Event|Stage 1,Group 6: rLP2086 (0- and 4-Month Schedule):|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.
11093011|NCT01543087|EG006|Reported Event|Stage 2, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093012|NCT01543087|EG007|Reported Event|Stage 2, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093013|NCT01543087|EG008|Reported Event|Stage 2, Group 4: rLP2086 (0-and 6-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093014|NCT01543087|EG009|Reported Event|Stage 2, Group 5: rLP2086 (0- and 2-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093015|NCT01543087|EG010|Reported Event|Stage 2, Group 6: rLP2086 (0- and 4-Month Schedule)|Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
11093016|NCT01543152|BG000|Baseline|Cohort 1 - IV Cyclophosphamide 200 mg|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
11093017|NCT01543152|BG001|Baseline|Cohort 2 - IV Cyclophosphamide 0.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
11093018|NCT01543152|BG002|Baseline|Cohort 3 - IV Cyclophosphamide 1.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
11093019|NCT01543152|BG003|Baseline|Cohort 4 - IV Cyclophosphamide 2.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
11093020|NCT01543152|BG004|Baseline|Cohort 5 - IV Cyclophosphamide 1.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
11093021|NCT01543152|BG005|Baseline|Total|Total of all reporting groups
11093022|NCT01543152|FG000|Participant Flow|Cohort 1 - IV Cyclophosphamide 200 mg|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
11093023|NCT01543152|FG001|Participant Flow|Cohort 2 - IV Cyclophosphamide 0.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
11093024|NCT01543152|FG002|Participant Flow|Cohort 3 - IV Cyclophosphamide 1.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
11093025|NCT01543152|FG003|Participant Flow|Cohort 4 - IV Cyclophosphamide 2.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
11093026|NCT01543152|FG004|Participant Flow|Cohort 5 - IV Cyclophosphamide 1.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
11093027|NCT01543152|OG000|Outcome|Cohort 1 - IV Cyclophosphamide 200 mg|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
11093028|NCT01543152|OG001|Outcome|Cohort 2 - IV Cyclophosphamide 0.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
11093029|NCT01543152|OG002|Outcome|Cohort 3 - IV Cyclophosphamide 1.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
11093030|NCT01543152|OG003|Outcome|Cohort 4 - IV Cyclophosphamide 2.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
11093031|NCT01543152|OG004|Outcome|Cohort 5 - IV Cyclophosphamide 1.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
10826817|NCT00105989|OG001|Outcome|Duloxetine 90 mg|duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
11093032|NCT01543152|EG000|Reported Event|Cohort 1 - IV Cyclophosphamide 200 mg|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
11093033|NCT01543152|EG001|Reported Event|Cohort 2 - IV Cyclophosphamide 0.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
11093034|NCT01543152|EG002|Reported Event|Cohort 3 - IV Cyclophosphamide 1.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
11093035|NCT01543152|EG003|Reported Event|Cohort 4 - IV Cyclophosphamide 2.0 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
11093036|NCT01543152|EG004|Reported Event|Cohort 5 - IV Cyclophosphamide 1.5 g/m2|SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
11093037|NCT01543178|BG000|Baseline|Open-label Rifaximin Only|The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
11093038|NCT01543178|BG001|Baseline|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
11093039|NCT01543178|BG002|Baseline|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
11093040|NCT01543178|BG003|Baseline|Total|Total of all reporting groups
11093041|NCT01543178|FG000|Participant Flow|Open-label Rifaximin|"Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.~Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo."
11093042|NCT01543178|FG001|Participant Flow|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
11093043|NCT01543178|FG002|Participant Flow|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
11093044|NCT01543178|OG000|Outcome|Double-blind Rifaximin (Retreatment)|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin."
11313177|NCT03196232|FG000|Participant Flow|Treatment (Epacadostat, Pembrolizumab)|"Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.~Epacadostat: Given PO~Pembrolizumab: Given IV"
11093045|NCT01543178|OG001|Outcome|Double-blind Placebo (Retreatment)|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo."
11093046|NCT01543178|EG000|Reported Event|Total Open-label Experience|"This group includes all 2579 subjects who received rifaximin the open-label period.~Open-label experience is shown here."
11093047|NCT01543178|EG001|Reported Event|Double-blind Retreatment Experience - Rifaximin Group|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin.~Double-blind experience is shown here."
11093048|NCT01543178|EG002|Reported Event|Double-blind Retreatment Experience - Placebo Group|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo.~Double-blind experience is shown here."
11093049|NCT01543204|BG000|Baseline|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
11093050|NCT01543204|FG000|Participant Flow|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
11093051|NCT01543204|OG000|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
11093052|NCT01543204|OG000|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
11093053|NCT01543204|OG001|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
11093054|NCT01543204|OG001|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
11093055|NCT01543204|OG000|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
11093056|NCT01543204|EG000|Reported Event|Etanercept 50mg BIW/50mg QW|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
11093057|NCT01543490|BG000|Baseline|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093058|NCT01543490|BG001|Baseline|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093059|NCT01543490|BG002|Baseline|Total|Total of all reporting groups
11093060|NCT01543490|FG000|Participant Flow|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093061|NCT01543490|FG001|Participant Flow|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093062|NCT01543490|OG000|Outcome|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093063|NCT01543490|OG001|Outcome|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093064|NCT01543490|EG000|Reported Event|ISV-305|ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093065|NCT01543490|EG001|Reported Event|Vehicle|Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 14 days.
11093066|NCT01543503|BG000|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093067|NCT01543503|BG001|Baseline|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093068|NCT01543503|BG002|Baseline|Total|Total of all reporting groups
11093069|NCT01543503|FG000|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093070|NCT01543503|FG001|Participant Flow|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093071|NCT01543503|OG000|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093072|NCT01543503|OG001|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093073|NCT01543503|EG000|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093074|NCT01543503|EG001|Reported Event|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
11093075|NCT01543568|BG000|Baseline|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
11093076|NCT01543568|FG000|Participant Flow|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
11093077|NCT01543568|OG000|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
11093078|NCT01543568|EG000|Reported Event|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
11093079|NCT01543581|BG000|Baseline|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
11093080|NCT01543581|FG000|Participant Flow|Vismodegib|Those to whom the drug is given.
11093081|NCT01543581|FG001|Participant Flow|Inactive Placebo|Those to whom the inactive placebo is given.
11093082|NCT01543581|OG000|Outcome|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
11093083|NCT01543581|OG000|Outcome|Vismodegib|Those to whom the drug is given.
11093084|NCT01543581|EG000|Reported Event|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
11093085|NCT01543581|EG001|Reported Event|Inactive Placebo|Those to whom the inactive placebo is given.
11093086|NCT01543607|BG000|Baseline|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
11093087|NCT01543607|FG000|Participant Flow|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
11093088|NCT01543607|OG000|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
11093089|NCT01543607|EG000|Reported Event|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
11093090|NCT01543685|BG000|Baseline|Celecoxib 200 mg|Celecoxib : 200 mg capsules
11093091|NCT01543685|BG001|Baseline|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
11093092|NCT01543685|BG002|Baseline|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
11093093|NCT01543685|BG003|Baseline|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
11093094|NCT01543685|BG004|Baseline|Placebo|Placebo : Capsules
11093095|NCT01543685|BG005|Baseline|Total|Total of all reporting groups
11093096|NCT01543685|FG000|Participant Flow|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
11313178|NCT03196232|OG000|Outcome|Treatment (Epacadostat, Pembrolizumab)|"Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.~Epacadostat: Given PO~Pembrolizumab: Given IV"
11093097|NCT01543685|FG001|Participant Flow|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
11093098|NCT01543685|FG002|Participant Flow|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
11093099|NCT01543685|FG003|Participant Flow|Celecoxib 200 mg|Celecoxib : 200 mg capsules
11093100|NCT01543685|FG004|Participant Flow|Placebo|Placebo : Capsules
11093101|NCT01543685|OG000|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
11093102|NCT01543685|OG001|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
11093103|NCT01543685|OG002|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
11093104|NCT01543685|OG003|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
11093105|NCT01543685|OG004|Outcome|Placebo|Placebo : Capsules
11093106|NCT01543685|EG000|Reported Event|Celecoxib 200 mg|Celecoxib : 200 mg capsules
11093107|NCT01543685|EG001|Reported Event|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
11093108|NCT01543685|EG002|Reported Event|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
11093109|NCT01543685|EG003|Reported Event|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
11093110|NCT01543685|EG004|Reported Event|Placebo|Placebo : Capsules
11093111|NCT01543776|BG000|Baseline|Arm I (Fasting)|"Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.~abiraterone acetate: Given PO"
11093112|NCT01543776|BG001|Baseline|Arm II (Fed)|"Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.~abiraterone acetate: Given PO"
11093113|NCT01543776|BG002|Baseline|Total|Total of all reporting groups
11093114|NCT01543776|FG000|Participant Flow|Arm I (Fasting)|"Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.~abiraterone acetate: Given PO"
11093115|NCT01543776|FG001|Participant Flow|Arm II (Fed)|"Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.~abiraterone acetate: Given PO"
11093116|NCT01543776|OG000|Outcome|Arm I (Fasting)|"Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.~abiraterone acetate: Given PO"
11093117|NCT01543776|OG001|Outcome|Arm II (Fed)|"Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.~abiraterone acetate: Given PO"
11093118|NCT01543776|EG000|Reported Event|Arm I (Fasting)|"Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.~abiraterone acetate: Given PO"
11093119|NCT01543776|EG001|Reported Event|Arm II (Fed)|"Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.~abiraterone acetate: Given PO"
11093120|NCT01543828|BG000|Baseline|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
11093121|NCT01543828|BG001|Baseline|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
10826818|NCT00105989|OG002|Outcome|Duloxetine 120 mg|duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
10826819|NCT00105989|EG000|Reported Event|Placebo|Placebo
11093122|NCT01543828|BG002|Baseline|Total|Total of all reporting groups
11093123|NCT01543828|FG000|Participant Flow|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
11093124|NCT01543828|FG001|Participant Flow|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
11093125|NCT01543828|OG000|Outcome|indacaterol_treatment 1|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.
11093126|NCT01543828|OG001|Outcome|indacaterol_treatment 2|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
11093127|NCT01543828|OG002|Outcome|placebo_treatment 1|In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.
11093128|NCT01543828|OG003|Outcome|placebo_treatment 2|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
11093129|NCT01543828|EG000|Reported Event|Indacaterol|Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
11093130|NCT01543828|EG001|Reported Event|Placebo|Participants received placebo one dose delivered via SDDPI.
11093131|NCT01543958|BG000|Baseline|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
11093132|NCT01543958|FG000|Participant Flow|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
11093133|NCT01543958|OG000|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
11093134|NCT01543958|EG000|Reported Event|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
11093135|NCT01544023|BG000|Baseline|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
11093136|NCT01544023|FG000|Participant Flow|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
11093137|NCT01544023|OG000|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
11093138|NCT01544023|EG000|Reported Event|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
11093139|NCT01544062|BG000|Baseline|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11093140|NCT01544062|BG001|Baseline|Normal Saline|Study subjects receiving placebo
11093141|NCT01544062|BG002|Baseline|Total|Total of all reporting groups
11093142|NCT01544062|FG000|Participant Flow|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11313179|NCT03196232|EG000|Reported Event|Treatment (Epacadostat, Pembrolizumab)|"Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.~Epacadostat: Given PO~Pembrolizumab: Given IV"
11093143|NCT01544062|FG001|Participant Flow|Normal Saline|Study subjects receiving placebo
11093144|NCT01544062|OG000|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11093145|NCT01544062|OG001|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11093146|NCT01544062|OG000|Outcome|Normal Saline|Study subjects receiving placebo
11093147|NCT01544062|EG000|Reported Event|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11093148|NCT01544062|EG001|Reported Event|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
11093149|NCT01544088|BG000|Baseline|Group Cognitive Behavioral Treatment (GCBT)|Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
11093150|NCT01544088|BG001|Baseline|Present Centered Group Treatment|Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
11093151|NCT01544088|BG002|Baseline|Total|Total of all reporting groups
11093152|NCT01544088|FG000|Participant Flow|Group Cognitive Behavioral Treatment (GCBT)|Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
11093153|NCT01544088|FG001|Participant Flow|Present Centered Group Treatment|Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
11093154|NCT01544088|OG000|Outcome|Group Cognitive Behavioral Treatment (GCBT)|Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
11093155|NCT01544088|OG001|Outcome|Present Centered Group Treatment|Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
11093156|NCT01544088|EG000|Reported Event|Group Cognitive Behavioral Treatment (GCBT)|Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
11093157|NCT01544088|EG001|Reported Event|Present Centered Group Treatment|Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
11093158|NCT01544114|BG000|Baseline|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093159|NCT01544114|BG001|Baseline|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093160|NCT01544114|BG002|Baseline|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093161|NCT01544114|BG003|Baseline|Total|Total of all reporting groups
11093162|NCT01544114|FG000|Participant Flow|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093163|NCT01544114|FG001|Participant Flow|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093164|NCT01544114|FG002|Participant Flow|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093165|NCT01544114|OG000|Outcome|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093166|NCT01544114|OG001|Outcome|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093167|NCT01544114|OG002|Outcome|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093168|NCT01544114|OG003|Outcome|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093169|NCT01544114|EG000|Reported Event|VIMOVO 250 mg/20 mg|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093170|NCT01544114|EG001|Reported Event|VIMOVO 375 mg/20 mg|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093171|NCT01544114|EG002|Reported Event|VIMOVO 500 mg/20 mg|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093172|NCT01544114|EG003|Reported Event|Total|250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
11093173|NCT01544153|BG000|Baseline|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
11093174|NCT01544153|BG001|Baseline|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
11093175|NCT01544153|BG002|Baseline|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093176|NCT01544153|BG003|Baseline|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093177|NCT01544153|BG004|Baseline|Total|Total of all reporting groups
11093178|NCT01544153|FG000|Participant Flow|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
11093179|NCT01544153|FG001|Participant Flow|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
11093180|NCT01544153|FG002|Participant Flow|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093181|NCT01544153|FG003|Participant Flow|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093182|NCT01544153|OG000|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
11093183|NCT01544153|OG001|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
10826820|NCT00105989|EG001|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg
11093184|NCT01544153|OG002|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093185|NCT01544153|OG003|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
10826821|NCT00105989|EG002|Reported Event|Duloxetine 90 mg|Duloxetine 90 mg
11093186|NCT01544153|EG000|Reported Event|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
11093187|NCT01544153|EG001|Reported Event|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
11093188|NCT01544153|EG002|Reported Event|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093189|NCT01544153|EG003|Reported Event|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
11093190|NCT01544166|BG000|Baseline|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
11093191|NCT01544166|FG000|Participant Flow|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
11093192|NCT01544166|OG000|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
11093193|NCT01544166|OG000|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
11093194|NCT01544166|OG001|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
11093195|NCT01544166|OG000|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
11093196|NCT01544166|EG000|Reported Event|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
11093197|NCT01544179|BG000|Baseline|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
11093198|NCT01544179|BG001|Baseline|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
11093199|NCT01544179|BG002|Baseline|Total|Total of all reporting groups
11093200|NCT01544179|FG000|Participant Flow|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
11093201|NCT01544179|FG001|Participant Flow|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
11093202|NCT01544179|OG000|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
11093203|NCT01544179|OG001|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
11093204|NCT01544179|EG000|Reported Event|Gefitinib 250 mg|
11093205|NCT01544179|EG001|Reported Event|Placebo|
10826822|NCT00105989|EG003|Reported Event|Duloxetine 120 mg|Duloxetine 120 mg
11093206|NCT01544309|BG000|Baseline|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
11093207|NCT01544309|BG001|Baseline|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
11093208|NCT01544309|BG002|Baseline|Total|Total of all reporting groups
11093209|NCT01544309|FG000|Participant Flow|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
11093210|NCT01544309|FG001|Participant Flow|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
11093211|NCT01544309|OG000|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
11093212|NCT01544309|OG001|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
11093213|NCT01544309|OG000|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
11093214|NCT01544309|OG001|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
11093215|NCT01544309|EG000|Reported Event|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
11093216|NCT01544309|EG001|Reported Event|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
11093217|NCT01544348|BG000|Baseline|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
11093218|NCT01544348|BG001|Baseline|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
11093219|NCT01544348|BG002|Baseline|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
11093220|NCT01544348|BG003|Baseline|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
11093221|NCT01544348|BG004|Baseline|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
11093222|NCT01544348|BG005|Baseline|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
11093223|NCT01544348|BG006|Baseline|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
11093224|NCT01544348|BG007|Baseline|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
11313180|NCT03196284|BG000|Baseline|Concizumab|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily. In main part, the initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313181|NCT03196284|BG001|Baseline|Eptacog Alfa|Participants were to receive eptacog alfa on-demand treatment for 24 weeks in main part. All participants were then switched to concizumab treatment in the extension part.
11313182|NCT03196284|BG002|Baseline|Total|Total of all reporting groups
10826823|NCT00106002|BG000|Baseline|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
11093225|NCT01544348|BG008|Baseline|Total|Total of all reporting groups
11093226|NCT01544348|FG000|Participant Flow|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
11093227|NCT01544348|FG001|Participant Flow|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
11093228|NCT01544348|FG002|Participant Flow|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
11093229|NCT01544348|FG003|Participant Flow|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
11093230|NCT01544348|FG004|Participant Flow|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
11093231|NCT01544348|FG005|Participant Flow|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
11093232|NCT01544348|FG006|Participant Flow|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
11093233|NCT01544348|FG007|Participant Flow|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
11093234|NCT01544348|OG000|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
11093235|NCT01544348|OG001|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
11093236|NCT01544348|OG002|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
11093237|NCT01544348|OG003|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
11093238|NCT01544348|OG004|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
11093239|NCT01544348|OG005|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
11093240|NCT01544348|OG006|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
11093241|NCT01544348|OG007|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
11093242|NCT01544348|OG000|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
11313183|NCT03196284|FG000|Participant Flow|Concizumab- Main Part|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
11313184|NCT03196284|FG001|Participant Flow|Eptacog Alfa- Main Part|Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
11093243|NCT01544348|OG001|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
11093244|NCT01544348|OG002|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
11093245|NCT01544348|OG003|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
11093246|NCT01544348|OG004|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
11093247|NCT01544348|OG005|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
11093248|NCT01544348|OG006|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
11093249|NCT01544348|EG000|Reported Event|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
11093250|NCT01544348|EG001|Reported Event|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
11093251|NCT01544348|EG002|Reported Event|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
11093252|NCT01544348|EG003|Reported Event|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
11093253|NCT01544348|EG004|Reported Event|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
11093254|NCT01544348|EG005|Reported Event|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
11093255|NCT01544348|EG006|Reported Event|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
10826824|NCT00106002|FG000|Participant Flow|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
11093256|NCT01544348|EG007|Reported Event|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
11093257|NCT01544361|BG000|Baseline|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
11093258|NCT01544361|BG001|Baseline|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
11093259|NCT01544361|BG002|Baseline|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093260|NCT01544361|BG003|Baseline|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
10826825|NCT00106002|OG000|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
11093261|NCT01544361|BG004|Baseline|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093262|NCT01544361|BG005|Baseline|TOTAL|Total of all reporting groups
11093263|NCT01544361|FG000|Participant Flow|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
11093264|NCT01544361|FG001|Participant Flow|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
11093265|NCT01544361|FG002|Participant Flow|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093266|NCT01544361|FG003|Participant Flow|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093267|NCT01544361|FG004|Participant Flow|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093268|NCT01544361|OG000|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
11093269|NCT01544361|OG001|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
11093270|NCT01544361|OG002|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093271|NCT01544361|OG003|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093272|NCT01544361|OG004|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093273|NCT01544361|EG000|Reported Event|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
11093274|NCT01544361|EG001|Reported Event|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
11093275|NCT01544361|EG002|Reported Event|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093276|NCT01544361|EG003|Reported Event|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093277|NCT01544361|EG004|Reported Event|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
11093278|NCT01544478|BG000|Baseline|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
11093279|NCT01544478|FG000|Participant Flow|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
11093280|NCT01544478|OG000|Outcome|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
11093281|NCT01544478|EG000|Reported Event|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
11093282|NCT01544491|BG000|Baseline|EVR+rTAC|Investigational arm : Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
11093283|NCT01544491|BG001|Baseline|MMF+sTAC|Control arm : MMF continuation (in combination with tacrolimus and standard dose steroids)
11093284|NCT01544491|BG002|Baseline|Total|Total of all reporting groups
11093285|NCT01544491|FG000|Participant Flow|EVR+rTAC|Investigational arm : Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
11093286|NCT01544491|FG001|Participant Flow|MMF+sTAC|Control arm : MMF continuation (in combination with tacrolimus and standard dose steroids)
11093287|NCT01544491|OG000|Outcome|EVR+rTAC|Investigational arm : Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
11093288|NCT01544491|OG001|Outcome|MMF+sTAC|Control arm : MMF continuation (in combination with tacrolimus and standard dose steroids)
11093289|NCT01544491|EG000|Reported Event|EVR+rTAC|EVR+rTAC
11093290|NCT01544491|EG001|Reported Event|MMF+sTAC|MMF+sTAC
11093291|NCT01544582|BG000|Baseline|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
11093292|NCT01544582|BG001|Baseline|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
11093293|NCT01544582|BG002|Baseline|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
11093294|NCT01544582|BG003|Baseline|Total|Total of all reporting groups
11093295|NCT01544582|FG000|Participant Flow|All Included Participants|All CHC genotype-1 participants included in study.
11093296|NCT01544582|FG001|Participant Flow|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
11093297|NCT01544582|FG002|Participant Flow|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
11093298|NCT01544582|FG003|Participant Flow|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
11093299|NCT01544582|OG000|Outcome|All Included Participants|All CHC genotype-1 participants included in study.
11093300|NCT01544582|OG000|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
11093301|NCT01544582|OG001|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
11093302|NCT01544582|OG002|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
11093303|NCT01544582|OG000|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
11093304|NCT01544582|OG001|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
11093305|NCT01544582|OG002|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
11093306|NCT01544582|OG003|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
11093307|NCT01544582|EG000|Reported Event|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
11093308|NCT01544582|EG001|Reported Event|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
11093309|NCT01544582|EG002|Reported Event|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
11093310|NCT01544595|BG000|Baseline|AIN457 150 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
11093311|NCT01544595|BG001|Baseline|AIN457 300 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
11093312|NCT01544595|BG002|Baseline|AIN457 150 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
11093313|NCT01544595|BG003|Baseline|AIN457 300 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
11093314|NCT01544595|BG004|Baseline|AIN457 150 mg - Partial Responders|PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study
11093315|NCT01544595|BG005|Baseline|AIN457 300 mg - Partial Responders|PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study
11093316|NCT01544595|BG006|Baseline|Total|Total of all reporting groups
11093317|NCT01544595|FG000|Participant Flow|AIN457 150 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
11093318|NCT01544595|FG001|Participant Flow|AIN457 300 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
11093319|NCT01544595|FG002|Participant Flow|AIN457 150 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
11093320|NCT01544595|FG003|Participant Flow|AIN457 300 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
11093321|NCT01544595|FG004|Participant Flow|AIN457 150 mg - Partial Responders|PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study
11093322|NCT01544595|FG005|Participant Flow|AIN457 300 mg - Partial Responders|PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study
11093323|NCT01544595|OG000|Outcome|AIN457 150 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
11093324|NCT01544595|OG001|Outcome|AIN457 300 mg -Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
11093325|NCT01544595|OG002|Outcome|AIN457 150 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
11093326|NCT01544595|OG003|Outcome|AIN457 300 mg Placebo - Randomized Withdrawal Period|PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
11093327|NCT01544595|OG000|Outcome|AIN457 150 mg Only|patients staying strictly on AIN457 150mg from Week 52
11093328|NCT01544595|OG001|Outcome|AIN457 300 mg Only|Patients staying strictly on AIN457 300mg from Week 52
11093329|NCT01544595|OG000|Outcome|Placebo - AIN457 150 mg|Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed
11093330|NCT01544595|OG001|Outcome|Placebo - AIN457 300 mg|Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed
11093331|NCT01544595|OG000|Outcome|Any AIN457 150 mg|Safety data from patients while on AIN457 150 mg
11093332|NCT01544595|OG001|Outcome|Any AIN457 300 mg|Safety data from patients while on AIN457 300 mg
11093333|NCT01544595|OG002|Outcome|Any AIN457|safety data from patients while on any dose of AIN457
11093334|NCT01544595|EG000|Reported Event|Any AIN457 150 mg|safety data from patients while on AIN457 150 mg
11093335|NCT01544595|EG001|Reported Event|Any AIN457 300 mg|safety data from patients while on AIN457 300 mg
11093336|NCT01544595|EG002|Reported Event|Any AIN457 Dose|safety data from patients while on any dose of AIN457
11093337|NCT01544595|EG003|Reported Event|AIN457 150 mg - Placebo|safety data from patients of corresponding randomized withdrawal group while on placebo
11093338|NCT01544595|EG004|Reported Event|AIN457 300 mg - Placebo|safety data from patients of corresponding randomized withdrawal group while on placebo
11093339|NCT01544920|BG000|Baseline|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
11093340|NCT01544920|BG001|Baseline|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
11093341|NCT01544920|BG002|Baseline|Total|Total of all reporting groups
11093342|NCT01544920|FG000|Participant Flow|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
11093343|NCT01544920|FG001|Participant Flow|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
11093344|NCT01544920|OG000|Outcome|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
11093345|NCT01544920|OG001|Outcome|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
11093346|NCT01544920|OG000|Outcome|Arm 1a: Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
11093347|NCT01544920|OG001|Outcome|Arm 2a: BOC + Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
11093348|NCT01544920|EG000|Reported Event|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
10826826|NCT00106002|EG000|Reported Event|Pemetrexed|Pemetrexed
10826827|NCT00106028|BG000|Baseline|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
11093349|NCT01544920|EG001|Reported Event|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
11093350|NCT01544998|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.
11093351|NCT01544998|FG000|Participant Flow|Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide|First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
11093352|NCT01544998|FG001|Participant Flow|Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo|First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
11093353|NCT01544998|OG000|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093354|NCT01544998|OG001|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093355|NCT01544998|EG000|Reported Event|PSD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093356|NCT01544998|EG001|Reported Event|PSD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093357|NCT01544998|EG002|Reported Event|PDD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093358|NCT01544998|EG003|Reported Event|PDD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
11093359|NCT01545076|BG000|Baseline|Pre-randomization Safety Data Set (PSDS)|Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
11093360|NCT01545076|FG000|Participant Flow|IgPro10 Re-stabilization|Subjects who experienced CIDP qualified for IVIG re-stabilization treatment with IgPro10 (10% IgG preparation for intravenous administration).
11093361|NCT01545076|FG001|Participant Flow|IgPro20 (0.4)|Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.4 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.
11093362|NCT01545076|FG002|Participant Flow|IgPro20 (0.2)|Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.2 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.
11093363|NCT01545076|FG003|Participant Flow|Placebo|Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. Placebo: 2% human albumin administered by weekly SC infusions.
11093364|NCT01545076|FG004|Participant Flow|IgPro10 Rescue|Subjects with CIDP relapse during the SC Treatment Period received IgPro10 (10% IgG preparation for intravenous administration) as rescue medication.
11093365|NCT01545076|OG000|Outcome|IgPro20 (0.4)|IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
11093366|NCT01545076|OG001|Outcome|IgPro20 (0.2)|IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
11093367|NCT01545076|OG002|Outcome|Placebo|Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
11093368|NCT01545076|OG000|Outcome|IgPro10|"Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during IgPro10 Restabilization.~IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks."
11093369|NCT01545076|OG000|Outcome|IgPro10|"Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.~IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks."
11093370|NCT01545076|OG000|Outcome|IgPro10|"Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.~IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks."
11093371|NCT01545076|EG000|Reported Event|IgPro10 Restabilization|"IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during restabilization.~IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks."
11093372|NCT01545076|EG001|Reported Event|IgPro20 (0.4)|IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.
11093373|NCT01545076|EG002|Reported Event|IgPro20 (0.2)|IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.
11093374|NCT01545076|EG003|Reported Event|Placebo|Placebo: 2% human albumin administered by weekly SC infusions during the IgPro20 SC treatment period of the study.
11093375|NCT01545076|EG004|Reported Event|IgPro10 Rescue|"IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during rescue.~IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks."
11093376|NCT01545141|BG000|Baseline|Surgery Only|Surgical resection only, performed as standard of care for the disease
11093377|NCT01545141|BG001|Baseline|Chemokine Modulatory Regimen (5 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093378|NCT01545141|BG002|Baseline|Chemokine Modulatory Regimen (10 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093379|NCT01545141|BG003|Baseline|Chemokine Modulatory Regimen (20 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093380|NCT01545141|BG004|Baseline|Total|Total of all reporting groups
11093381|NCT01545141|FG000|Participant Flow|Surgery Only|Surgical resection only, performed as standard of care for the disease
11093382|NCT01545141|FG001|Participant Flow|Chemokin Modulatory Regimen (5 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093383|NCT01545141|FG002|Participant Flow|Chemokin Modulatory Regimen (10 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days"
11093384|NCT01545141|FG003|Participant Flow|Chemokin Modulatory Regimen (20 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days"
11093385|NCT01545141|OG000|Outcome|Surgery Only|Surgical resection only, performed as standard of care for the disease
11093386|NCT01545141|OG001|Outcome|Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 2 dose of and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093387|NCT01545141|OG001|Outcome|Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 2 dose of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093388|NCT01545141|EG000|Reported Event|Surgery Only|Surgical resection only, performed as standard of care for the disease
11093389|NCT01545141|EG001|Reported Event|Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093390|NCT01545141|EG002|Reported Event|Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093391|NCT01545141|EG003|Reported Event|Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)|"Chemokine Modulatory Regimen monday through Friday prior to surgery:~400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days~Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2."
11093392|NCT01545193|BG000|Baseline|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093393|NCT01545193|BG001|Baseline|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093394|NCT01545193|BG002|Baseline|Total|Total of all reporting groups
11093395|NCT01545193|FG000|Participant Flow|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093396|NCT01545193|FG001|Participant Flow|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093397|NCT01545193|OG000|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093398|NCT01545193|OG001|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093399|NCT01545193|EG000|Reported Event|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093400|NCT01545193|EG001|Reported Event|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
11093401|NCT01545232|BG000|Baseline|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
11093402|NCT01545232|BG001|Baseline|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
11093403|NCT01545232|BG002|Baseline|Total|Total of all reporting groups
11093404|NCT01545232|FG000|Participant Flow|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
11093405|NCT01545232|FG001|Participant Flow|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
11313185|NCT03196284|FG002|Participant Flow|Concizumab- Extension Part|Participants who completed main part treatment were to receive s.c. injection of concizumab once daily for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with 0.15 mg/kg of concizumab. The dose was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313186|NCT03196284|OG000|Outcome|Concizumab- Main Part|Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
11313187|NCT03196284|OG001|Outcome|Eptacog Alfa- Main Part|Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
11313188|NCT03196284|OG000|Outcome|Concizumab|Participants were to receive s.c. injection of concizumab once daily. In main part, the initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313189|NCT03196284|OG000|Outcome|Concizumab 0.15 mg/kg- Main Part|Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
11313190|NCT03196284|OG001|Outcome|Concizumab 0.20 mg/kg- Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
11313191|NCT03196284|OG002|Outcome|Eptacog Alfa- Main Part|Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
11313192|NCT03196284|OG000|Outcome|Concizumab 0.15 mg/kg|Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313193|NCT03196284|OG001|Outcome|Concizumab 0.20 mg/kg|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313194|NCT03196284|OG002|Outcome|Concizumab 0.25 mg/kg|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study continued their treatment in the extension part for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with concizumab. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 μg/kg eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313195|NCT03196284|OG000|Outcome|Eptacog Alfa- Main Part|Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
11313196|NCT03196284|OG000|Outcome|Concizumab- Main Part|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
11313197|NCT03196284|OG000|Outcome|Concizumab|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily. In main part, the initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
11313198|NCT03196284|EG000|Reported Event|Eptacog Alfa- Main Part|Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
11313199|NCT03196284|EG001|Reported Event|Concizumab 0.15 mg/kg- Main Part|Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
11313200|NCT03196284|EG002|Reported Event|Concizumab 0.20 mg/kg- Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
11093406|NCT01545232|OG000|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
11093407|NCT01545232|OG001|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
11093408|NCT01545232|OG000|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio.
11093409|NCT01545232|OG001|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio.
11093410|NCT01545232|EG000|Reported Event|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
11093411|NCT01545232|EG001|Reported Event|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
11093412|NCT01545336|BG000|Baseline|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
11093413|NCT01545336|BG001|Baseline|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
11093414|NCT01545336|BG002|Baseline|Total|Total of all reporting groups
11093415|NCT01545336|FG000|Participant Flow|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
11093416|NCT01545336|FG001|Participant Flow|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
11093417|NCT01545336|OG000|Outcome|Anastrozole|"1 mg tablet by mouth once daily for 3 months~Anastrozole: 1 mg tablet to be taken 1 time daily"
11093418|NCT01545336|OG001|Outcome|Placebo|"Placebo tablet by mouth once daily for 3 months~Placebo: 1 mg tablet to be taken 1 time daily"
11093419|NCT01545336|OG000|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
11093420|NCT01545336|OG001|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
11093421|NCT01545336|EG000|Reported Event|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
11093422|NCT01545336|EG001|Reported Event|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
11093423|NCT01545375|BG000|Baseline|dPly-PhtD Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093424|NCT01545375|BG001|Baseline|Control Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093425|NCT01545375|BG002|Baseline|Total|Total of all reporting groups
11093426|NCT01545375|FG000|Participant Flow|dPly-PhtD Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11217711|NCT02315872|OG000|Outcome|ACTH|"The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.~ACTH: ACTH injections twice weekly for 28 weeks."
11217712|NCT02315872|OG001|Outcome|Placebo|"Placebo will be given subcutaneously twice weekly for 28 weeks.~Placebo: Placebo injections twice weekly for 28 weeks."
11313201|NCT03196284|EG003|Reported Event|Concizumab 0.15 mg/kg- Extension Part|Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The dose of concizumab was 0.15 mg/kg.
11313202|NCT03196284|EG004|Reported Event|Concizumab 0.20 mg/kg- Extension Part|Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes.
11313203|NCT03196284|EG005|Reported Event|Concizumab 0.25 mg/kg- Extension Part|Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes.
11313204|NCT03196297|BG000|Baseline|Concizumab|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313205|NCT03196297|FG000|Participant Flow|Concizumab|Participants received subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (at least 24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes.
11313206|NCT03196297|OG000|Outcome|Concizumab 0.15 mg/kg- Main Part|Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313207|NCT03196297|OG001|Outcome|Concizumab 0.20 mg/kg- Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313208|NCT03196297|OG002|Outcome|Concizumab 0.25 mg/kg- Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313209|NCT03196297|OG000|Outcome|Concizumab 0.15 mg/kg|Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313210|NCT03196297|OG001|Outcome|Concizumab 0.20 mg/kg|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313211|NCT03196297|OG002|Outcome|Concizumab 0.25 mg/kg|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313212|NCT03196297|OG000|Outcome|Concizumab - Main Part|Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313213|NCT03196297|OG000|Outcome|Concizumab|Participants who completed main part treatment were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313214|NCT03196297|EG000|Reported Event|Concizumab 0.15 mg/kg - Main Part|Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313215|NCT03196297|EG001|Reported Event|Concizumab 0.20 mg/kg - Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11093427|NCT01545375|FG001|Participant Flow|Control Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093428|NCT01545375|OG000|Outcome|dPly-PhtD Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093429|NCT01545375|OG001|Outcome|Control Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093430|NCT01545375|EG000|Reported Event|dPly/PhtD Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093431|NCT01545375|EG001|Reported Event|Control Group|Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
11093432|NCT01545388|BG000|Baseline|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
11093433|NCT01545388|BG001|Baseline|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
11093434|NCT01545388|BG002|Baseline|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
11093435|NCT01545388|BG003|Baseline|Total|Total of all reporting groups
11093436|NCT01545388|FG000|Participant Flow|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
11093437|NCT01545388|FG001|Participant Flow|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
11093438|NCT01545388|FG002|Participant Flow|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
11093439|NCT01545388|OG000|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
11093440|NCT01545388|OG001|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
11093441|NCT01545388|OG002|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
11093442|NCT01545388|EG000|Reported Event|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
11093443|NCT01545388|EG001|Reported Event|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
11093444|NCT01545388|EG002|Reported Event|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
11093445|NCT01545583|BG000|Baseline|Placebo IV|Placebo administered once intravenously (IV).
11093446|NCT01545583|BG001|Baseline|Placebo SC|Placebo administered once subcutaneously (SC).
11093447|NCT01545583|BG002|Baseline|0.1 mg LY3016859 IV|0.1 milligram (mg) LY3016859 administered once intravenously.
11093448|NCT01545583|BG003|Baseline|1 mg LY3016859 IV|1 mg LY3016859 administered once intravenously.
11093449|NCT01545583|BG004|Baseline|10 mg LY3016859 IV|10 mg LY3016859 administered once intravenously.
11093450|NCT01545583|BG005|Baseline|50 mg LY3016859 IV|50 mg LY3016859 administered once intravenously.
11093451|NCT01545583|BG006|Baseline|250 mg LY3016859 IV|250 mg LY3016859 administered once intravenously.
11093452|NCT01545583|BG007|Baseline|750 mg LY3016859 IV|750 mg LY3016859 administered once intravenously.
11093453|NCT01545583|BG008|Baseline|50 mg LY3016859 SC|50 mg LY3016859 administered once subcutaneously.
11093454|NCT01545583|BG009|Baseline|Total|Total of all reporting groups
11093455|NCT01545583|FG000|Participant Flow|Placebo IV|Placebo administered once intravenously (IV).
11093456|NCT01545583|FG001|Participant Flow|Placebo SC|Placebo administered once subcutaneously (SC).
11093457|NCT01545583|FG002|Participant Flow|0.1 mg LY3016859 IV|0.1 milligram (mg) LY3016859 administered once intravenously.
11093458|NCT01545583|FG003|Participant Flow|1 mg LY3016859 IV|1 mg LY3016859 administered once intravenously.
11093459|NCT01545583|FG004|Participant Flow|10 mg LY3016859 IV|10 mg LY3016859 administered once intravenously.
11093460|NCT01545583|FG005|Participant Flow|50 mg LY3016859 IV|50 mg LY3016859 administered once intravenously.
11093461|NCT01545583|FG006|Participant Flow|250 mg LY3016859 IV|250 mg LY3016859 administered once intravenously.
11093462|NCT01545583|FG007|Participant Flow|750 mg LY3016859 IV|750 mg LY3016859 administered once intravenously.
11093463|NCT01545583|FG008|Participant Flow|50 mg LY3016859 SC|50 mg LY3016859 administered once subcutaneously.
11093464|NCT01545583|OG000|Outcome|Placebo IV|Placebo administered once intravenously (IV).
11093465|NCT01545583|OG001|Outcome|Placebo SC|Placebo administered once subcutaneously (SC).
11093466|NCT01545583|OG002|Outcome|0.1 mg LY3016859 IV|0.1 milligram (mg) LY3016859 administered once intravenously.
11093467|NCT01545583|OG003|Outcome|1 mg LY3016859 IV|1 mg LY3016859 administered once intravenously.
11093468|NCT01545583|OG004|Outcome|10 mg LY3016859 IV|10 mg LY3016859 administered once intravenously.
11093469|NCT01545583|OG005|Outcome|50 mg LY3016859 IV|50 mg LY3016859 administered once intravenously.
11093470|NCT01545583|OG006|Outcome|250 mg LY3016859 IV|250 mg LY3016859 administered once intravenously.
11093471|NCT01545583|OG007|Outcome|750 mg LY3016859 IV|750 mg LY3016859 administered once intravenously.
11093472|NCT01545583|OG008|Outcome|50 mg LY3016859 SC|50 mg LY3016859 administered once subcutaneously.
11093473|NCT01545583|OG000|Outcome|0.1 mg LY3016859 IV|0.1 milligram (mg) LY3016859 administered once intravenously (IV).
11093474|NCT01545583|OG001|Outcome|1 mg LY3016859 IV|1 mg LY3016859 administered once intravenously.
11093475|NCT01545583|OG002|Outcome|10 mg LY3016859 IV|10 mg LY3016859 administered once intravenously.
11093476|NCT01545583|OG003|Outcome|50 mg LY3016859 IV|50 mg LY3016859 administered once intravenously.
11093477|NCT01545583|OG004|Outcome|250 mg LY3016859 IV|250 mg LY3016859 administered once intravenously.
11093478|NCT01545583|OG005|Outcome|750 mg LY3016859 IV|750 mg LY3016859 administered once intravenously.
11093479|NCT01545583|OG006|Outcome|50 mg LY3016859 SC|50 mg LY3016859 administered once subcutaneously (SC).
11093480|NCT01545583|EG000|Reported Event|Placebo IV|Placebo administered once intravenously (IV).
11093481|NCT01545583|EG001|Reported Event|Placebo SC|Placebo administered once subcutaneously (SC).
11093482|NCT01545583|EG002|Reported Event|0.1 mg LY3016859 IV|0.1 milligram (mg) LY3016859 administered once intravenously.
11093483|NCT01545583|EG003|Reported Event|1 mg LY3016859 IV|1 mg LY3016859 administered once intravenously.
11093484|NCT01545583|EG004|Reported Event|10 mg LY3016859 IV|10 mg LY3016859 administered once intravenously.
11093485|NCT01545583|EG005|Reported Event|50 mg LY3016859 IV|50 mg LY3016859 administered once intravenously.
11093486|NCT01545583|EG006|Reported Event|250 mg LY3016859 IV|250 mg LY3016859 administered once intravenously.
11093487|NCT01545583|EG007|Reported Event|750 mg LY3016859 IV|750 mg LY3016859 administered once intravenously.
11093488|NCT01545583|EG008|Reported Event|50 mg LY3016859 SC|50 mg LY3016859 administered once subcutaneously.
11093489|NCT01545700|BG000|Baseline|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
11093490|NCT01545700|BG001|Baseline|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
11093491|NCT01545700|BG002|Baseline|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
11093492|NCT01545700|BG003|Baseline|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
11093493|NCT01545700|BG004|Baseline|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
11093494|NCT01545700|BG005|Baseline|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
11093495|NCT01545700|BG006|Baseline|Total|Total of all reporting groups
11093496|NCT01545700|FG000|Participant Flow|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
11093497|NCT01545700|FG001|Participant Flow|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
10826828|NCT00106028|BG001|Baseline|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
10826829|NCT00106028|BG002|Baseline|Total|Total of all reporting groups
10826830|NCT00106028|FG000|Participant Flow|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
10826831|NCT00106028|FG001|Participant Flow|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
10826832|NCT00106028|OG000|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
10826833|NCT00106028|OG001|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
10826834|NCT00106028|EG000|Reported Event|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
10826835|NCT00106028|EG001|Reported Event|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
10826836|NCT00106028|EG002|Reported Event|Years 2 & 3 Placebo-Risedronate|Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate
10826837|NCT00106028|EG003|Reported Event|Years 2 & 3 Risedronate|Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
10826838|NCT00106080|BG000|Baseline|Intervention|Audit and feedback
10826839|NCT00106080|BG001|Baseline|Control|Usual care
10826840|NCT00106080|BG002|Baseline|Total|Total of all reporting groups
10826841|NCT00106080|FG000|Participant Flow|Intervention (Audit and Feedback)|We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
10826842|NCT00106080|FG001|Participant Flow|Control (Usual Care)|We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
10826843|NCT00106080|OG000|Outcome|Intervention|Audit and Feedback
10826844|NCT00106080|OG001|Outcome|Control|Usual care
10826845|NCT00106080|EG000|Reported Event|Intervention|Audit and Feedback
10826846|NCT00106080|EG001|Reported Event|Control|Usual care
10826847|NCT00106106|BG000|Baseline|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
10826848|NCT00106106|BG001|Baseline|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
10826849|NCT00106106|BG002|Baseline|Total|Total of all reporting groups
10826850|NCT00106106|FG000|Participant Flow|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
10826851|NCT00106106|FG001|Participant Flow|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
10826852|NCT00106106|OG000|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
10826853|NCT00106106|OG001|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
10826854|NCT00106106|EG000|Reported Event|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
10826855|NCT00106106|EG001|Reported Event|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
10826856|NCT00106119|BG000|Baseline|Entire Study Population|Includes groups randomized to receive Levothyroxine first and Liothyronine first.
10826857|NCT00106119|FG000|Participant Flow|Liothyronine First, Then Levothyroxine|Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period)
10826858|NCT00106119|FG001|Participant Flow|Levothyroxine First, Then Liothyronine|Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
10826859|NCT00106119|OG000|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
10826860|NCT00106119|OG000|Outcome|Liothyronine/Levothyroxine Therapy Intervention ArmArm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
10826861|NCT00106119|EG000|Reported Event|Levothyroxine Period|Patients at Levothyroxine Period
10826862|NCT00106119|EG001|Reported Event|Liothyronine Period|Patients at Liothyronine Period
10826863|NCT00106184|BG000|Baseline|Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
10826864|NCT00106184|BG001|Baseline|Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
10826865|NCT00106184|BG002|Baseline|Total|Total of all reporting groups
10826866|NCT00106184|FG000|Participant Flow|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
10826867|NCT00106184|FG001|Participant Flow|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
10826868|NCT00106184|OG000|Outcome|Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
10826869|NCT00106184|OG001|Outcome|Group B (Rituximab Wks 8 and 9)|"Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
10826870|NCT00106184|OG000|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
10826871|NCT00106184|OG001|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
10826872|NCT00106184|EG000|Reported Event|Treatment Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
10826873|NCT00106184|EG001|Reported Event|Treatment Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
10826874|NCT00106249|BG000|Baseline|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
10826875|NCT00106249|BG001|Baseline|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
10826876|NCT00106249|BG002|Baseline|Total|Total of all reporting groups
10826877|NCT00106249|FG000|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
10826878|NCT00106249|FG001|Participant Flow|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
10826879|NCT00106249|OG000|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
10826880|NCT00106249|OG001|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
10826881|NCT00106249|EG000|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
10826882|NCT00106249|EG001|Reported Event|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
10826883|NCT00106353|BG000|Baseline|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
10826884|NCT00106353|BG001|Baseline|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826885|NCT00106353|BG002|Baseline|Total|Total of all reporting groups
10826886|NCT00106353|FG000|Participant Flow|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
10826887|NCT00106353|FG001|Participant Flow|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826888|NCT00106353|FG002|Participant Flow|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826889|NCT00106353|FG003|Participant Flow|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826890|NCT00106353|FG004|Participant Flow|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826891|NCT00106353|FG005|Participant Flow|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826892|NCT00106353|FG006|Participant Flow|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826893|NCT00106353|OG000|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
11093498|NCT01545700|FG002|Participant Flow|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
11093499|NCT01545700|FG003|Participant Flow|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
11093500|NCT01545700|FG004|Participant Flow|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
11093501|NCT01545700|FG005|Participant Flow|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
11093502|NCT01545700|OG000|Outcome|Placebo 0-4 Hours|Placebo 0-4 hours baseline
11093503|NCT01545700|OG001|Outcome|Dexamethasone 4 mg 0-4 Hours|
11093504|NCT01545700|OG002|Outcome|Dexamethasone 8 mg 0-4 Hours|
11093505|NCT01545700|OG003|Outcome|Placebo 8-24 Hours|
11093506|NCT01545700|OG004|Outcome|Dexamethasone 4 mg 8-24 Hours|
11093507|NCT01545700|OG005|Outcome|Dexamethasone 8 mg 8-24 Hours|
11093508|NCT01545700|OG000|Outcome|Placebo 0-4 Hours-baseline|Placebo 0-4 hours baseline
11093509|NCT01545700|OG001|Outcome|Placebo 0-4 Hours-1 Hour|Placebo 0-4 hours-1 hour
11093510|NCT01545700|OG002|Outcome|Placebo 0-4 Hours-2 Hours|Placebo 0-4 hours-2 hours
11093511|NCT01545700|OG003|Outcome|Placebo 0-4 Hours-3 Hours|
11093512|NCT01545700|OG004|Outcome|Placebo 0-4 Hours-4 Hours|
11093513|NCT01545700|OG005|Outcome|Dexamethasone 4 mg 0-4 Hours-baseline|
11093514|NCT01545700|OG006|Outcome|Dexamethasone 4 mg 0-4 Hours-1 Hour|
11093515|NCT01545700|OG007|Outcome|Dexamethasone 4 mg 0-4 Hours-2 Hours|
11093516|NCT01545700|OG008|Outcome|Dexamethasone 4 mg 0-4 Hours-3 Hours|
11093517|NCT01545700|OG009|Outcome|Dexamethasone 4 mg 0-4 Hours-4 Hours|
11093518|NCT01545700|OG010|Outcome|Dexamethasone 8 mg 0-4 Hours-baseline|
11093519|NCT01545700|OG011|Outcome|Dexamethasone 8 mg 0-4 Hours-1 Hour|
11093520|NCT01545700|OG012|Outcome|Dexamethasone 8 mg 0-4 Hours-2 Hours|
11093521|NCT01545700|OG013|Outcome|Dexamethasone 8 mg 0-4 Hours-3 Hours|
11093522|NCT01545700|OG014|Outcome|Dexamethasone 8 mg 0-4 Hours-4 Hours|
11093523|NCT01545700|OG015|Outcome|Placebo 8-24 Hours Baseline|
11093524|NCT01545700|OG016|Outcome|Placebo 8-24 Hours-8 Hours|
11093525|NCT01545700|OG017|Outcome|Placebo 8-24 Hours-24 Hours|
11093526|NCT01545700|OG018|Outcome|Dexamethasone 4 mg 8-24 Hours-baseline|
11093527|NCT01545700|OG019|Outcome|Dexamethasone 4 mg 8-24 Hours-8 Hours|
11093528|NCT01545700|OG020|Outcome|Dexamethasone 4 mg 8-24 Hours-24 Hours|
11093529|NCT01545700|OG021|Outcome|Dexamethasone 8 mg 8-24 Hours-baseline|
11093530|NCT01545700|OG022|Outcome|Dexamethasone 8 mg 8-24 Hours-8 Hours|
11093531|NCT01545700|OG023|Outcome|Dexamethasone 8 mg 8-24 Hours-24 Hours|
11093532|NCT01545700|EG000|Reported Event|Control-saline Group|
11093533|NCT01545700|EG001|Reported Event|Dexamethasone Group|either 4 mg or 8 mg
11093534|NCT01545765|BG000|Baseline|Lidocaine 7% and Tetracaine 7%|
11093535|NCT01545765|FG000|Participant Flow|Face 2 Application Times/ Thight 2 Application Times|
11093536|NCT01545765|OG000|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
11093537|NCT01545765|OG001|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
11093538|NCT01545765|OG002|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
11093539|NCT01545765|OG003|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
11093540|NCT01545765|EG000|Reported Event|Lidocaine 7% + Tetracaine 7%|
11093541|NCT01545817|BG000|Baseline|All Patients|All patients were assigned to first-line treatment with pazopanib once daily. Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily as second-line treatment.
11093542|NCT01545817|FG000|Participant Flow|Pazopanib|All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
11093543|NCT01545817|FG001|Participant Flow|Everolimus|Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
11093544|NCT01545817|OG000|Outcome|Everolimus|Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
11093545|NCT01545817|OG000|Outcome|All Patients|All patients were assigned to first-line treatment with pazopanib once daily. Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily as second-line treatment.
11093546|NCT01545817|OG000|Outcome|Pazopanib|All patients were assigned to first-line treatment with pazopanib once daily.
11093547|NCT01545817|OG000|Outcome|Pazopanib|All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
11093548|NCT01545817|EG000|Reported Event|Pazopanib|All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
11093549|NCT01545817|EG001|Reported Event|Everolimus|"Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment.~Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments."
11093550|NCT01545843|BG000|Baseline|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093551|NCT01545843|BG001|Baseline|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093552|NCT01545843|BG002|Baseline|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093553|NCT01545843|BG003|Baseline|Total|Total of all reporting groups
11093554|NCT01545843|FG000|Participant Flow|No Sleep Deprivation|8 hours time in bed for two weeks plus fluoxetine for 8 weeks
11093555|NCT01545843|FG001|Participant Flow|Late Bedtime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
11093556|NCT01545843|FG002|Participant Flow|Early Risetime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours.
11093557|NCT01545843|OG000|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093558|NCT01545843|OG001|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093559|NCT01545843|OG002|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093560|NCT01545843|OG000|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093561|NCT01545843|OG001|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093562|NCT01545843|OG002|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093563|NCT01545843|EG000|Reported Event|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093564|NCT01545843|EG001|Reported Event|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093565|NCT01545843|EG002|Reported Event|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
11093566|NCT01545934|BG000|Baseline|Standard Care|Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)
11093567|NCT01545934|BG001|Baseline|Lifestyle Intervention|Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
11093568|NCT01545934|BG002|Baseline|Total|Total of all reporting groups
11093569|NCT01545934|FG000|Participant Flow|Standard Care|Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)
11093570|NCT01545934|FG001|Participant Flow|Lifestyle Intervention|Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
11093571|NCT01545934|OG000|Outcome|Standard Care|Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)
11093572|NCT01545934|OG001|Outcome|Lifestyle Intervention|Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
11093573|NCT01545934|OG000|Outcome|Standard Care|Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC) (
11093574|NCT01545934|EG000|Reported Event|Standard Care|Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)
11093575|NCT01545934|EG001|Reported Event|Lifestyle Intervention|Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
11093576|NCT01546038|BG000|Baseline|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
11093577|NCT01546038|BG001|Baseline|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
11093578|NCT01546038|BG002|Baseline|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
11217713|NCT02315872|EG000|Reported Event|ACTH|"The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.~ACTH: ACTH injections twice weekly for 28 weeks."
11093579|NCT01546038|BG003|Baseline|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093580|NCT01546038|BG004|Baseline|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
11093581|NCT01546038|BG005|Baseline|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
11093582|NCT01546038|BG006|Baseline|Total|Total of all reporting groups
11093583|NCT01546038|FG000|Participant Flow|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
11093584|NCT01546038|FG001|Participant Flow|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
11093585|NCT01546038|FG002|Participant Flow|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
11093586|NCT01546038|FG003|Participant Flow|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
11093587|NCT01546038|FG004|Participant Flow|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093588|NCT01546038|FG005|Participant Flow|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
11093589|NCT01546038|FG006|Participant Flow|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093590|NCT01546038|FG007|Participant Flow|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
11093591|NCT01546038|FG008|Participant Flow|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
11093592|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
11093593|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
11093594|NCT01546038|OG002|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
11093595|NCT01546038|OG003|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
11093596|NCT01546038|OG004|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093597|NCT01546038|OG005|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
11093598|NCT01546038|OG000|Outcome|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093599|NCT01546038|OG000|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
11093600|NCT01546038|OG001|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
11093601|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib + LDAC|Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
11093602|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib + Decitabine|Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
11093603|NCT01546038|OG002|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
11093604|NCT01546038|OG001|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
11093605|NCT01546038|OG002|Outcome|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
11093606|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
11093607|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
11217714|NCT02315872|EG001|Reported Event|Placebo|"Placebo will be given subcutaneously twice weekly for 28 weeks.~Placebo: Placebo injections twice weekly for 28 weeks."
11217715|NCT02315989|BG000|Baseline|Safety|"proton therapy~proton therapy: proton therapy"
11093608|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093609|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
11093610|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
11093611|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib + LDAC (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093612|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib + LDAC (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093613|NCT01546038|OG002|Outcome|Phase 1B: Glasdegib + Decitabine (Biomarker,Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093614|NCT01546038|OG003|Outcome|Phase 1B: Glasdegib + Decitabine (Biomaker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093615|NCT01546038|OG004|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
11093616|NCT01546038|OG005|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
11093617|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib + Cytarabine/Daunorubicin|Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
11093618|NCT01546038|OG000|Outcome|Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
11093619|NCT01546038|OG001|Outcome|Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
11093620|NCT01546038|OG000|Outcome|Phase 2 Fit (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093621|NCT01546038|OG001|Outcome|Phase 2 Fit (Biomarker,Non-Responder)|AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093622|NCT01546038|OG002|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093623|NCT01546038|OG003|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093624|NCT01546038|OG004|Outcome|Phase 2 Unfit: LDAC Alone (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093625|NCT01546038|OG005|Outcome|Phase 2 Unfit: LDAC Alone (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093626|NCT01546038|OG000|Outcome|Phase 2 Fit (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093627|NCT01546038|OG001|Outcome|Phase 2 Fit (Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
10826894|NCT00106353|OG001|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826895|NCT00106353|OG002|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826896|NCT00106353|OG003|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826897|NCT00106353|OG000|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826898|NCT00106353|OG001|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826899|NCT00106353|OG002|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826900|NCT00106353|OG003|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
10826901|NCT00106353|OG000|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
10826902|NCT00106353|OG000|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826903|NCT00106353|OG000|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
10826904|NCT00106353|OG001|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826905|NCT00106353|EG000|Reported Event|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
10826906|NCT00106353|EG001|Reported Event|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
10826907|NCT00106353|EG002|Reported Event|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
10826908|NCT00106353|EG003|Reported Event|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
10826909|NCT00106353|EG004|Reported Event|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826910|NCT00106353|EG005|Reported Event|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826911|NCT00106353|EG006|Reported Event|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
10826912|NCT00106392|BG000|Baseline|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
10826913|NCT00106392|BG001|Baseline|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
10826914|NCT00106392|BG002|Baseline|Total|Total of all reporting groups
10826915|NCT00106392|FG000|Participant Flow|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
10826916|NCT00106392|FG001|Participant Flow|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
10826917|NCT00106392|OG000|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
11217716|NCT02315989|FG000|Participant Flow|Safety|"proton therapy~proton therapy: proton therapy"
10826918|NCT00106392|OG001|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
10826919|NCT00106392|EG000|Reported Event|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
10826920|NCT00106392|EG001|Reported Event|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
10826921|NCT00106431|BG000|Baseline|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
10826922|NCT00106431|FG000|Participant Flow|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
10826923|NCT00106431|OG000|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
10826924|NCT00106431|EG000|Reported Event|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
11217717|NCT02315989|OG000|Outcome|Safety|"proton therapy~proton therapy: proton therapy"
11093628|NCT01546038|OG000|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093629|NCT01546038|OG001|Outcome|Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)|AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
11093630|NCT01546038|OG000|Outcome|Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)|AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
11093631|NCT01546038|EG000|Reported Event|Phase 1B: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). Low dose Ara-C (LDAC) was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
11093632|NCT01546038|EG001|Reported Event|Phase 1B: Glasdegib 200 mg + LDAC|Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
11093633|NCT01546038|EG002|Reported Event|Phase 1B: Glasdegib 100 mg + Decitabine|Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
11093634|NCT01546038|EG003|Reported Event|Phase 1B: Glasdegib 200 mg + Decitabine|Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.
11093635|NCT01546038|EG004|Reported Event|Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11093636|NCT01546038|EG005|Reported Event|Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
11093637|NCT01546038|EG006|Reported Event|Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin|Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m^2 administered as a 3-hour IV infusion every 12 hours (2 g/m^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
11313216|NCT03196297|EG002|Reported Event|Concizumab 0.25 mg/kg - Main Part|Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11093638|NCT01546038|EG007|Reported Event|Phase 2 Unfit: Glasdegib 100 mg + LDAC|Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles.
11093639|NCT01546038|EG008|Reported Event|Phase 2 Unfit: LDAC Alone|Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28-day cycles.
11093640|NCT01546142|BG000|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093641|NCT01546142|BG001|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093642|NCT01546142|BG002|Baseline|Total|Total of all reporting groups
11093643|NCT01546142|FG000|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093644|NCT01546142|FG001|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093645|NCT01546142|OG000|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093646|NCT01546142|OG001|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093647|NCT01546142|EG000|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093648|NCT01546142|EG001|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
11093649|NCT01546155|BG000|Baseline|Healthy Volunteers|"The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, control conditions."
11093650|NCT01546155|FG000|Participant Flow|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale.
11093651|NCT01546155|OG000|Outcome|Healthy Controls|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
11093652|NCT01546155|EG000|Reported Event|Healthy Volunteers|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
11093653|NCT01546168|BG000|Baseline|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
11093654|NCT01546168|BG001|Baseline|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
11093655|NCT01546168|BG002|Baseline|Total|Total of all reporting groups
11093656|NCT01546168|FG000|Participant Flow|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
11093657|NCT01546168|FG001|Participant Flow|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
11093658|NCT01546168|OG000|Outcome|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
11093659|NCT01546168|OG001|Outcome|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
11093660|NCT01546168|EG000|Reported Event|Esophageal Deviation|esophageal deviation with IDE device during AF ablation
11093661|NCT01546168|EG001|Reported Event|Temperature Monitoring|luminal esophageal standing temperature monitoring alone
11093662|NCT01546194|BG000|Baseline|Morning Consent|"Consent process consisting of information only provided on the morning of surgery~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
11093663|NCT01546194|BG001|Baseline|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
11093664|NCT01546194|BG002|Baseline|Total|Total of all reporting groups
11093665|NCT01546194|FG000|Participant Flow|Morning Consent|Consent process consisting of information only provided on the morning of surgery
11093666|NCT01546194|FG001|Participant Flow|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
11093667|NCT01546194|OG000|Outcome|Morning Consent|Consent process consisting of information only provided on the morning of surgery
11093668|NCT01546194|OG001|Outcome|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
11093669|NCT01546194|EG000|Reported Event|Morning Consent|Consent process consisting of information only provided on the morning of surgery
11093670|NCT01546194|EG001|Reported Event|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
11093671|NCT01546285|BG000|Baseline|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
11093672|NCT01546285|FG000|Participant Flow|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
11093673|NCT01546285|OG000|Outcome|B40 and PRO1000 - Systolic BP|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
11093674|NCT01546285|OG001|Outcome|B40 and PRO1000 - Diastolic BP|
11093675|NCT01546285|OG002|Outcome|B40 and PRO1000 - MAP|
11093676|NCT01546285|EG000|Reported Event|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
11093677|NCT01546402|BG000|Baseline|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
11093678|NCT01546402|BG001|Baseline|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
11093679|NCT01546402|BG002|Baseline|Total|Total of all reporting groups
11093680|NCT01546402|FG000|Participant Flow|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
11093681|NCT01546402|FG001|Participant Flow|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
11093682|NCT01546402|OG000|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
11093683|NCT01546402|OG001|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
11217718|NCT02315989|OG000|Outcome|The Frequency of Operation of the System Error|6 subjects received a total of 165 proton therapy, a total of 21 times the system running abnormalities. There was no correlation between system abnormalities during the study and the adverse events.
11217719|NCT02315989|OG000|Outcome|Stable Disease|Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
11217720|NCT02315989|OG001|Outcome|Partial Response|Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
10826925|NCT00106535|BG000|Baseline|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
10826926|NCT00106535|BG001|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
10826927|NCT00106535|BG002|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
10826928|NCT00106535|BG003|Baseline|Total|Total of all reporting groups
10826929|NCT00106535|FG000|Participant Flow|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
10826930|NCT00106535|FG001|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
10826931|NCT00106535|FG002|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
10826932|NCT00106535|FG003|Participant Flow|All Tocilizumab Exposure + MTX|All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.
10826933|NCT00106535|OG000|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
10826934|NCT00106535|OG001|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
10826935|NCT00106535|OG002|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
10826936|NCT00106535|OG000|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
10826937|NCT00106535|OG000|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
10826938|NCT00106535|OG000|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
10826939|NCT00106535|OG001|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
10826940|NCT00106535|EG000|Reported Event|Placebo + Methotrexate|"Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.~Total Exposure Placebo + MTX = 282.36 patient-years (PY)."
10826941|NCT00106535|EG001|Reported Event|All Tocilizumab 4 mg/kg + Methotrexate|"All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 4mg + MTX = 580.99 PY."
10826942|NCT00106535|EG002|Reported Event|All Tocilizumab 8 mg/kg + Methotrexate|"All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 8mg + MTX = 3797.94 PY."
10826943|NCT00106639|BG000|Baseline|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
10826944|NCT00106639|BG001|Baseline|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
10826945|NCT00106639|BG002|Baseline|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
10826946|NCT00106639|BG003|Baseline|Total|Total of all reporting groups
10826947|NCT00106639|FG000|Participant Flow|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
10826948|NCT00106639|FG001|Participant Flow|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
10826949|NCT00106639|FG002|Participant Flow|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
10826950|NCT00106639|OG000|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
10826951|NCT00106639|OG001|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
10826952|NCT00106639|OG002|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
11093684|NCT01546402|EG000|Reported Event|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
11093685|NCT01546402|EG001|Reported Event|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
11093686|NCT01546454|BG000|Baseline|All Study Participants|
11093687|NCT01546454|FG000|Participant Flow|All Study Participants|
11093688|NCT01546454|OG000|Outcome|Non-steroidal Effects|"Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
11093689|NCT01546454|OG001|Outcome|Contraceptive Effects|"Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.~Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days~leuprolide acetate: single 22.5 mg subcutaneous depot suspension"
11093690|NCT01546454|OG002|Outcome|Steroid Effects|"Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
11093691|NCT01546454|EG000|Reported Event|All Study Participants|
11093692|NCT01546519|BG000|Baseline|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093693|NCT01546519|BG001|Baseline|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093694|NCT01546519|BG002|Baseline|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093695|NCT01546519|BG003|Baseline|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093696|NCT01546519|BG004|Baseline|Total|Total of all reporting groups
11093697|NCT01546519|FG000|Participant Flow|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
11217721|NCT02315989|OG002|Outcome|Inevaluable|Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
11217722|NCT02315989|EG000|Reported Event|Safety|"proton therapy~proton therapy: proton therapy"
11093698|NCT01546519|FG001|Participant Flow|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093699|NCT01546519|FG002|Participant Flow|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093700|NCT01546519|FG003|Participant Flow|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093701|NCT01546519|OG000|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093702|NCT01546519|OG001|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093703|NCT01546519|OG002|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093704|NCT01546519|OG003|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093705|NCT01546519|OG000|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
11093706|NCT01546519|OG001|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093707|NCT01546519|OG002|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093708|NCT01546519|OG003|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093709|NCT01546519|EG000|Reported Event|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
10826953|NCT00106639|OG000|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
11093710|NCT01546519|EG001|Reported Event|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093711|NCT01546519|EG002|Reported Event|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093712|NCT01546519|EG003|Reported Event|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
11093713|NCT01546623|BG000|Baseline|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
11093714|NCT01546623|BG001|Baseline|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
11093715|NCT01546623|BG002|Baseline|Total|Total of all reporting groups
11093716|NCT01546623|FG000|Participant Flow|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
11093717|NCT01546623|FG001|Participant Flow|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
11093718|NCT01546623|OG000|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
11093719|NCT01546623|OG001|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
11093720|NCT01546623|EG000|Reported Event|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
11093721|NCT01546623|EG001|Reported Event|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
11093722|NCT01546636|BG000|Baseline|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
11093723|NCT01546636|BG001|Baseline|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
11093724|NCT01546636|BG002|Baseline|Total|Total of all reporting groups
11093725|NCT01546636|FG000|Participant Flow|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
11093726|NCT01546636|FG001|Participant Flow|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
11093727|NCT01546636|OG000|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
11093728|NCT01546636|OG001|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
10826954|NCT00106639|EG000|Reported Event|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
11093729|NCT01546636|EG000|Reported Event|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
11093730|NCT01546636|EG001|Reported Event|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
11093731|NCT01546649|BG000|Baseline|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093732|NCT01546649|BG001|Baseline|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093733|NCT01546649|BG002|Baseline|Total|Total of all reporting groups
11093734|NCT01546649|FG000|Participant Flow|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093735|NCT01546649|FG001|Participant Flow|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093736|NCT01546649|OG000|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093737|NCT01546649|OG001|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093738|NCT01546649|EG000|Reported Event|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093739|NCT01546649|EG001|Reported Event|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
11093740|NCT01546675|BG000|Baseline|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
11093741|NCT01546675|BG001|Baseline|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design
11093742|NCT01546675|BG002|Baseline|Total|Total of all reporting groups
11093743|NCT01546675|FG000|Participant Flow|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
11093744|NCT01546675|FG001|Participant Flow|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
11217723|NCT02316171|BG000|Baseline|CVA21|CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules:
11093745|NCT01546675|OG000|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
11093746|NCT01546675|OG001|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
11093747|NCT01546675|OG000|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|.Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
11093748|NCT01546675|EG000|Reported Event|Cases|Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design.
11093749|NCT01546688|BG000|Baseline|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
11093750|NCT01546688|BG001|Baseline|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
11093751|NCT01546688|BG002|Baseline|Total|Total of all reporting groups
11093752|NCT01546688|FG000|Participant Flow|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
11093753|NCT01546688|FG001|Participant Flow|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
11093754|NCT01546688|OG000|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
11093755|NCT01546688|OG001|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
11093756|NCT01546688|EG000|Reported Event|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
11093757|NCT01546688|EG001|Reported Event|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
11093758|NCT01546857|BG000|Baseline|Placebo|"Placebo one dose in the evening of surgery and post op day #1.~Placebo: Placebo"
11093759|NCT01546857|BG001|Baseline|Gabapentin|"Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively~Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively."
11093760|NCT01546857|BG002|Baseline|Total|Total of all reporting groups
11093761|NCT01546857|FG000|Participant Flow|Placebo|"Placebo one dose in the evening of surgery and post op day #1.~Placebo: Placebo"
11093762|NCT01546857|FG001|Participant Flow|Gabapentin|"Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively~Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively."
11093763|NCT01546857|OG000|Outcome|Placebo|"Placebo one dose in the evening of surgery and post op day #1.~Placebo: Placebo"
11093764|NCT01546857|OG001|Outcome|Gabapentin|"Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively~Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively."
11093765|NCT01546857|OG000|Outcome|Placebo|"Placebo one dose in the evening of surgery and post op day #1.~Placebo: Normal Saline"
11093766|NCT01546857|EG000|Reported Event|Placebo|"Placebo one dose in the evening of surgery and post op day #1.~Placebo: Placebo"
11093767|NCT01546857|EG001|Reported Event|Gabapentin|"Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively~Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively."
11093768|NCT01546922|BG000|Baseline|All Participants|All participants completing both study periods
11093769|NCT01546922|FG000|Participant Flow|First a Low Dose of HC Followed by a High Dose of HC|First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight
11093770|NCT01546922|FG001|Participant Flow|First a High Dose of HC Followed by a Low Dose of HC|First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
11093771|NCT01546922|OG000|Outcome|Low Dose of Hydrocortisone|Results from the participants while receiving the low dose of hydrocortisone
11093772|NCT01546922|OG001|Outcome|High Dose of Hydrocortisone|Results from the participants while receiving the high dose of hydrocortisone
11093773|NCT01546922|EG000|Reported Event|Low Dose of HC|Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks
11093774|NCT01546922|EG001|Reported Event|High Dose of HC|Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
11093775|NCT01547000|BG000|Baseline|Inactive Placebo|placebo: Administered up to 8 weeks
11093776|NCT01547000|BG001|Baseline|Extended-release Guanfacine|extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11093777|NCT01547000|BG002|Baseline|Total|Total of all reporting groups
11093778|NCT01547000|FG000|Participant Flow|Inactive Placebo|placebo: Administered up to 8 weeks
11093779|NCT01547000|FG001|Participant Flow|Extended-release Guanfacine|extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11093780|NCT01547000|OG000|Outcome|Inactive Placebo|placebo: Administered up to 8 weeks.
11093781|NCT01547000|OG001|Outcome|Extended-release Guanfacine|extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
11093782|NCT01547000|EG000|Reported Event|Inactive Placebo|placebo: Administered up to 8 weeks
11093783|NCT01547000|EG001|Reported Event|Extended-release Guanfacine|extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
11093784|NCT01547130|BG000|Baseline|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
11093785|NCT01547130|BG001|Baseline|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
11093786|NCT01547130|BG002|Baseline|Total|Total of all reporting groups
11093787|NCT01547130|FG000|Participant Flow|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
11093788|NCT01547130|FG001|Participant Flow|HalfLytely Colon Prep (HCP)|Patients followed the preparation method according to the manufacturer's standard instructions.
11093789|NCT01547130|OG000|Outcome|Shudh Colon Cleanse (SCC) Group|Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.
11093790|NCT01547130|OG001|Outcome|HalfLytely Colon Prep (HCP) Group|Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.
11093791|NCT01547130|OG000|Outcome|Shudh Colon Cleanse (SCC) Group|Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
11093792|NCT01547130|OG001|Outcome|HalfLytely Colon Prep (HCP) Group|Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
11093793|NCT01547130|OG000|Outcome|Shudh Colon Cleanse (SCC) Group|Subjects rated the SCC as palatable
11093794|NCT01547130|OG001|Outcome|HalfLytely Colon Prep (HCP) Group|Subjects rated the HCP as palatable
11093795|NCT01547130|OG000|Outcome|Shudh Colon Cleanse (SCC) Group|Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.
11093796|NCT01547130|OG001|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.
11093797|NCT01547130|OG000|Outcome|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
11093798|NCT01547130|OG001|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
11093799|NCT01547130|EG000|Reported Event|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
11093800|NCT01547130|EG001|Reported Event|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
11093801|NCT01547247|BG000|Baseline|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093802|NCT01547247|BG001|Baseline|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093803|NCT01547247|BG002|Baseline|Total|Total of all reporting groups
11093804|NCT01547247|FG000|Participant Flow|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093805|NCT01547247|FG001|Participant Flow|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093806|NCT01547247|OG000|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093807|NCT01547247|OG001|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093808|NCT01547247|EG000|Reported Event|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11093809|NCT01547247|EG001|Reported Event|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
11217724|NCT02316171|BG001|Baseline|CVA21/MitomycinC|Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC
11217725|NCT02316171|BG002|Baseline|Total|Total of all reporting groups
11217726|NCT02316171|FG000|Participant Flow|A1 - CVA21 1x10^8 TCID50|CAVATAK was administered by intravesical instillation at 1x10^8 TCID50.
11093810|NCT01547286|BG000|Baseline|Allergic Asthmatic|Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge. Nebulized methacholine inhalation: Standard
11093811|NCT01547286|FG000|Participant Flow|Allergic Asthmatic|This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
11093812|NCT01547286|OG000|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
11093813|NCT01547286|OG000|Outcome|Allergic Asthmatic|All subjects were allergic asthmatics, each served as their own control. There was no comparator group.
11093814|NCT01547286|EG000|Reported Event|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge"
11093815|NCT01547299|BG000|Baseline|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
11093816|NCT01547299|BG001|Baseline|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
11093817|NCT01547299|BG002|Baseline|Total|Total of all reporting groups
11093818|NCT01547299|FG000|Participant Flow|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 milligram (mg) of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
11093819|NCT01547299|FG001|Participant Flow|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
11093820|NCT01547299|OG000|Outcome|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
11093821|NCT01547299|OG001|Outcome|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
11093822|NCT01547299|EG000|Reported Event|Enzalutamide + Leuprolide + Dutasteride|Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
11093823|NCT01547299|EG001|Reported Event|Enzalutamide|Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
11093824|NCT01547390|BG000|Baseline|Placebo|1 capsule orally daily
11093825|NCT01547390|BG001|Baseline|Aspirin|81mg, 1 capsule orally daily
11093826|NCT01547390|BG002|Baseline|Total|Total of all reporting groups
11093827|NCT01547390|FG000|Participant Flow|Placebo|Study subjects receiving placebo one tablet orally per day
11093828|NCT01547390|FG001|Participant Flow|Aspirin|Study subjects receiving aspirin 81 mg one tablet orally per day.
11093829|NCT01547390|OG000|Outcome|Placebo|1 capsule orally, daily
11093830|NCT01547390|OG001|Outcome|Aspirin|81mg, 1 capsule orally daily
11093831|NCT01547390|EG000|Reported Event|Placebo|1 capsule orally, daily
11093832|NCT01547390|EG001|Reported Event|Aspirin|81mg, 1 capsule orally daily
11093833|NCT01547598|BG000|Baseline|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
11093834|NCT01547598|BG001|Baseline|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
11093835|NCT01547598|BG002|Baseline|Total|Total of all reporting groups
11093836|NCT01547598|FG000|Participant Flow|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
11093837|NCT01547598|FG001|Participant Flow|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
11093838|NCT01547598|OG000|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
11093839|NCT01547598|OG001|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
11093840|NCT01547598|EG000|Reported Event|Travatan® Z|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
11093841|NCT01547598|EG001|Reported Event|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
11093842|NCT01547598|EG002|Reported Event|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
11093843|NCT01547715|BG000|Baseline|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1
11093844|NCT01547715|BG001|Baseline|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1
11093845|NCT01547715|BG002|Baseline|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.
11093846|NCT01547715|BG003|Baseline|Total|Total of all reporting groups
11093847|NCT01547715|FG000|Participant Flow|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1.
11093848|NCT01547715|FG001|Participant Flow|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1.
11093849|NCT01547715|FG002|Participant Flow|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.
11093850|NCT01547715|OG000|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093851|NCT01547715|OG001|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093852|NCT01547715|OG002|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093853|NCT01547715|OG003|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093854|NCT01547715|EG000|Reported Event|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093855|NCT01547715|EG001|Reported Event|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093856|NCT01547715|EG002|Reported Event|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1
11093857|NCT01547715|EG003|Reported Event|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
11093858|NCT01547780|BG000|Baseline|Baseline Brain PET in Acute TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to baseline brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093859|NCT01547780|BG001|Baseline|Single Brain PET in Chronic TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
11093860|NCT01547780|BG002|Baseline|Single Brain PET in Healthy Subjects|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects.
11093861|NCT01547780|BG003|Baseline|Total|Total of all reporting groups
11093862|NCT01547780|FG000|Participant Flow|Baseline Brain PET in Acute TBI Patient|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093863|NCT01547780|FG001|Participant Flow|Repeat Brain PET in Acute TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093864|NCT01547780|FG002|Participant Flow|Single Brain PET in Chronic TBI Patient|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
11093865|NCT01547780|FG003|Participant Flow|Single Brain PET in Healthy Subjects|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
11093866|NCT01547780|OG000|Outcome|Baseline Brain PET in Acute TBI Patient|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093867|NCT01547780|OG001|Outcome|Repeat Brain PET in Acute TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093868|NCT01547780|OG002|Outcome|Single Brain PET in Chronic TBI Patient|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
11093869|NCT01547780|OG003|Outcome|Single Brain PET in Healthy Subjects|One ~10-20 mCi intravenous injection of [C-11]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
11093870|NCT01547780|EG000|Reported Event|Baseline Brain PET in Acute TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to baseline brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093871|NCT01547780|EG001|Reported Event|Repeat Brain PET in Acute TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (< 5 months post-injury) traumatic brain injury (TBI) patients.
11093872|NCT01547780|EG002|Reported Event|Single Brain PET in Chronic TBI Patient|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
11093873|NCT01547780|EG003|Reported Event|Single Brain PET in Healthy Subjects|Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects.
11093874|NCT01547806|BG000|Baseline|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106^ CD34+ cells/kg."
11093875|NCT01547806|FG000|Participant Flow|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
11093876|NCT01547806|OG000|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
11093877|NCT01547806|OG000|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
11093878|NCT01547806|EG000|Reported Event|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.~Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days~Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight~Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
11093879|NCT01548040|BG000|Baseline|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
11093880|NCT01548040|BG001|Baseline|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
11093881|NCT01548040|BG002|Baseline|Total|Total of all reporting groups
11093882|NCT01548040|FG000|Participant Flow|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
11093883|NCT01548040|FG001|Participant Flow|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
10826955|NCT00106639|EG001|Reported Event|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
11093884|NCT01548040|OG000|Outcome|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
11093885|NCT01548040|OG001|Outcome|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
11093886|NCT01548040|EG000|Reported Event|Quadriceps NMES Using Kneehab XP|"All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively"
11093887|NCT01548040|EG001|Reported Event|Quadriceps TENS|"The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation~quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively."
11093888|NCT01548287|BG000|Baseline|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
11093889|NCT01548287|BG001|Baseline|AZD5213 Dose B|AZD 5213 2.0 mg daily
11093890|NCT01548287|BG002|Baseline|AZD5213 Dose C|AZD5213 6.0 mg daily
11093891|NCT01548287|BG003|Baseline|Placebo|Placebo daily
11093892|NCT01548287|BG004|Baseline|Total|Total of all reporting groups
11093893|NCT01548287|FG000|Participant Flow|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
11093894|NCT01548287|FG001|Participant Flow|AZD5213 Dose B|AZD 5213 2.0 mg daily
11093895|NCT01548287|FG002|Participant Flow|AZD5213 Dose C|AZD5213 6.0 mg daily
11093896|NCT01548287|FG003|Participant Flow|Placebo|Placebo daily
11093897|NCT01548287|FG004|Participant Flow|Screening Only|Screening period only, not randomized
11093898|NCT01548287|OG000|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
11093899|NCT01548287|OG001|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
11093900|NCT01548287|OG002|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
11093901|NCT01548287|OG003|Outcome|Placebo|Placebo daily
11093902|NCT01548287|EG000|Reported Event|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
11093903|NCT01548287|EG001|Reported Event|AZD5213 Dose B|AZD 5213 2.0 mg daily
11093904|NCT01548287|EG002|Reported Event|AZD5213 Dose C|AZD5213 6.0 mg daily
11093905|NCT01548287|EG003|Reported Event|Placebo|Placebo daily
11093906|NCT01548339|BG000|Baseline|Delayed|"Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093907|NCT01548339|BG001|Baseline|Early|"Laparoscopic cholecystectomy performed directly after the initial diagnosis~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093908|NCT01548339|BG002|Baseline|Total|Total of all reporting groups
11093909|NCT01548339|FG000|Participant Flow|Delayed|"Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093910|NCT01548339|FG001|Participant Flow|Early|"Laparoscopic cholecystectomy performed directly after the initial diagnosis~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093911|NCT01548339|OG000|Outcome|Delayed|"Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093912|NCT01548339|OG001|Outcome|Early|"Laparoscopic cholecystectomy performed directly after the initial diagnosis~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093913|NCT01548339|EG000|Reported Event|Delayed|"Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093914|NCT01548339|EG001|Reported Event|Early|"Laparoscopic cholecystectomy performed directly after the initial diagnosis~Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy"
11093915|NCT01548404|BG000|Baseline|Placebo|Placebo (for Dupilumab) once weekly for 12 weeks by SC injection.
10826956|NCT00106639|EG002|Reported Event|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
11093916|NCT01548404|BG001|Baseline|Dupilumab 300 mg|Dupilumab 300 mg once weekly for 12 weeks by SC injection.
11093917|NCT01548404|BG002|Baseline|Total|Total of all reporting groups
11093918|NCT01548404|FG000|Participant Flow|Placebo|Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.
11093919|NCT01548404|FG001|Participant Flow|Dupilumab 300 mg|Dupilumab 300 mg once weekly for 12 weeks by SC injection.
11093920|NCT01548404|OG000|Outcome|Placebo|Placebo (for Dupilumab) once weekly for 12 weeks by SC injection.
11093921|NCT01548404|OG001|Outcome|Dupilumab 300 mg|Dupilumab 300 mg once weekly for 12 weeks by SC injection.
11093922|NCT01548404|OG000|Outcome|Placebo|Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.
11093923|NCT01548404|EG000|Reported Event|Placebo|Placebo (for Dupilumab) once weekly for 12 weeks by SC injection.
11093924|NCT01548404|EG001|Reported Event|Dupilumab 300 mg|Dupilumab 300 mg once weekly for 12 weeks by SC injection.
11093925|NCT01548417|BG000|Baseline|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
11093926|NCT01548417|BG001|Baseline|Placebo|Sugar Pill: placebo, oral pill, 7 days
11093927|NCT01548417|BG002|Baseline|Total|Total of all reporting groups
11093928|NCT01548417|FG000|Participant Flow|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
11093929|NCT01548417|FG001|Participant Flow|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
11093930|NCT01548417|OG000|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
11093931|NCT01548417|OG001|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
11093932|NCT01548417|EG000|Reported Event|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
11093933|NCT01548417|EG001|Reported Event|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
11093934|NCT01548573|BG000|Baseline|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
11093935|NCT01548573|FG000|Participant Flow|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
11093936|NCT01548573|OG000|Outcome|Tandem Autologous Stem Cell Transplant|"Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.~Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.~Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.~DP"
11093937|NCT01548573|OG000|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
11093938|NCT01548573|EG000|Reported Event|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
11093939|NCT01548599|BG000|Baseline|Intervention|Participants received the fiance and agricultural Intervention
11093940|NCT01548599|BG001|Baseline|Control Arm|Participants received the standard of care
11093941|NCT01548599|BG002|Baseline|Total|Total of all reporting groups
11093942|NCT01548599|FG000|Participant Flow|Intervention|Participants received the multisectoral agricultural Intervention
11093943|NCT01548599|FG001|Participant Flow|Control Arm|Participants received the standard of care
11093944|NCT01548599|OG000|Outcome|Multi-sectoral Agricultural Intervention|"Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.~Multi-sectoral agricultural intervention: Participants in the intervention arm will receive a micro-finance loan and training on financial management and marketing skills. With the loan, each participant will receive vouchers to purchase the following items: the Money Maker hip pump, 50 feet of hosing, fertilizer, and government certified seeds. Participants in the intervention group will also receive training on the use of the Money Maker hip pump, a portable, low-cost, human-powered water pump developed by KickStart. Participants in the intervention group will also receive training from Kickstart on the use of the pump as well as complementary training in best horticultural practices."
11093945|NCT01548599|OG001|Outcome|Control|Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
11093946|NCT01548599|OG000|Outcome|Intervention|"Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.~Multi-sectoral agricultural intervention: Participants in the intervention arm will receive a micro-finance loan and training on financial management and marketing skills. With the loan, each participant will receive vouchers to purchase the following items: the Money Maker hip pump, 50 feet of hosing, fertilizer, and government certified seeds. Participants in the intervention group will also receive training on the use of the Money Maker hip pump, a portable, low-cost, human-powered water pump developed by KickStart. Participants in the intervention group will also receive training from Kickstart on the use of the pump as well as complementary training in best horticultural practices."
11093947|NCT01548599|OG000|Outcome|Intervention|Participants received the multisectoral agricultural Intervention
11093948|NCT01548599|OG001|Outcome|Control Arm|Participants received the standard of care
11093949|NCT01548599|EG000|Reported Event|Intervention|Participants received the multisectoral agricultural Intervention
11093950|NCT01548599|EG001|Reported Event|Control Arm|Participants received the standard of care
11093951|NCT01548638|BG000|Baseline|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
11093952|NCT01548638|FG000|Participant Flow|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
11093953|NCT01548638|OG000|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
11093954|NCT01548638|OG000|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
11093955|NCT01548638|EG000|Reported Event|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
11093956|NCT01548690|BG000|Baseline|Maximum Dose Level 3.33 g/24h|Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.
11093957|NCT01548690|BG001|Baseline|Maximum Dose Level 6.65 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.
11093958|NCT01548690|BG002|Baseline|Maximum Dose Level 10 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.
11093959|NCT01548690|BG003|Baseline|Maximum Dose Level 20g/24h|Study drug infused at a dose of 20g/24h from initiation of infusion for up to 120 hours.
11093960|NCT01548690|BG004|Baseline|Total|Total of all reporting groups
11093961|NCT01548690|FG000|Participant Flow|Maximum Dose Level 3.33 g/24h|Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.
11093962|NCT01548690|FG001|Participant Flow|Maximum Dose Level 6.65 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.
11093963|NCT01548690|FG002|Participant Flow|Maximum Dose Level 10 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.
11093964|NCT01548690|FG003|Participant Flow|Maximum Dose Level 20g/24h|Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
11093965|NCT01548690|OG000|Outcome|Maximum Dose Level 3.33 g/24h|Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.
11093966|NCT01548690|OG001|Outcome|Maximum Dose Level 6.65 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.
11093967|NCT01548690|OG002|Outcome|Maximum Dose Level 10 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.
11093968|NCT01548690|OG003|Outcome|Maximum Dose Level 20g/24h|Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
11093969|NCT01548690|OG001|Outcome|Maximum Dose Level 6.65 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of 120 hours.
11093970|NCT01548690|OG002|Outcome|Maximum Dose Level 10 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of 120 hours.
11093971|NCT01548690|OG003|Outcome|Maximum Dose Level 20g/24h|Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of 120 hours.
11093972|NCT01548690|EG000|Reported Event|Maximum Dose Level 3.33 g/24h|Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.
11093973|NCT01548690|EG001|Reported Event|Maximum Dose Level 6.65 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of 120 hours.
11093974|NCT01548690|EG002|Reported Event|Maximum Dose Level 10 g/24h|Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of 120 hours.
11093975|NCT01548690|EG003|Reported Event|Maximum Dose Level 20g/24h|Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of 120 hours.
11093976|NCT01548742|BG000|Baseline|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
11093977|NCT01548742|BG001|Baseline|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
11093978|NCT01548742|BG002|Baseline|Total|Total of all reporting groups
11093979|NCT01548742|FG000|Participant Flow|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
11093980|NCT01548742|FG001|Participant Flow|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
11093981|NCT01548742|OG000|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
11093982|NCT01548742|OG001|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
11093983|NCT01548742|OG000|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
11093984|NCT01548742|OG001|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
11093985|NCT01548742|EG000|Reported Event|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
11093986|NCT01548742|EG001|Reported Event|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
11093987|NCT01548768|BG000|Baseline|Patients - DMARDs + TNF Inhibitors|"Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.~TNF inhibitors: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.~The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11093988|NCT01548768|BG001|Baseline|Patients - DMARDs Only|"Patients will receive their current treatment in an open label protocol in the context of standard of care.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11093989|NCT01548768|BG002|Baseline|Healthy Volunteers|Subjects without RA who will function as controls.
11093990|NCT01548768|BG003|Baseline|Patients - Cross Sectional (RA)|A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.
11093991|NCT01548768|BG004|Baseline|Total|Total of all reporting groups
11093992|NCT01548768|FG000|Participant Flow|Patients - DMARDs + TNF Inhibitors|"Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.~TNF inhibitors: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.~The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11093993|NCT01548768|FG001|Participant Flow|Patients - DMARDs Only|"Patients will receive their current treatment in an open label protocol in the context of standard of care.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11093994|NCT01548768|FG002|Participant Flow|Healthy Volunteers|Subjects without RA who will function as controls.
11093995|NCT01548768|FG003|Participant Flow|Patients - Cross Sectional (RA)|A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.
11093996|NCT01548768|OG000|Outcome|Patients - Cross Sectional (RA)|A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.
11093997|NCT01548768|OG001|Outcome|Healthy Volunteers|A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive.
11093998|NCT01548768|OG000|Outcome|RA Patients - Pharmacotherapy Escalation (TNFi)|"Participants were randomized to TNFi or DMARD therapy.~Patients will receive their current treatment in an open label protocol in the context of standard of care.~TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,"
11093999|NCT01548768|OG001|Outcome|RA Patients - Pharmacotherapy Escalation (DMARD)|"Participants were randomized to TNFi or DMARD therapy.~Patients will receive their current treatment in an open label protocol in the context of standard of care.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11094000|NCT01548768|OG002|Outcome|Healthy Volunteers|A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive.
11094001|NCT01548768|OG001|Outcome|Healthy Volunteers|A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive
11094002|NCT01548768|EG000|Reported Event|RA Patients - Pharmacotherapy Escalation (TNFi)|"Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.~TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,"
11094003|NCT01548768|EG001|Reported Event|RA Patients - Pharmacotherapy Escalation (DMARD)|"Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.~DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs."
11094004|NCT01548768|EG002|Reported Event|Healthy Volunteers|Subjects without RA who will function as controls.
11094005|NCT01548768|EG003|Reported Event|Patients - Cross Sectional (RA)|A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.
11094006|NCT01548833|BG000|Baseline|Overall|DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
11094007|NCT01548833|FG000|Participant Flow|Overall|All enrolled participants
11094008|NCT01548833|OG000|Outcome|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
11094009|NCT01548833|OG001|Outcome|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
11094010|NCT01548833|OG002|Outcome|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
11094011|NCT01548833|EG000|Reported Event|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
11094012|NCT01548833|EG001|Reported Event|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
11094013|NCT01548833|EG002|Reported Event|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
11094014|NCT01548885|BG000|Baseline|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
11094015|NCT01548885|FG000|Participant Flow|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
11094016|NCT01548885|OG000|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
11094017|NCT01548885|EG000|Reported Event|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
11094018|NCT01549002|BG000|Baseline|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
11094019|NCT01549002|BG001|Baseline|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
11094020|NCT01549002|BG002|Baseline|Total|Total of all reporting groups
11094021|NCT01549002|FG000|Participant Flow|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
11094022|NCT01549002|FG001|Participant Flow|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
11094023|NCT01549002|OG000|Outcome|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
11094024|NCT01549002|OG001|Outcome|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
11094025|NCT01549002|EG000|Reported Event|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
11094026|NCT01549002|EG001|Reported Event|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
11094027|NCT01549041|BG000|Baseline|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
11094028|NCT01549041|BG001|Baseline|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
11094029|NCT01549041|BG002|Baseline|Total|Total of all reporting groups
11094030|NCT01549041|FG000|Participant Flow|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
11094031|NCT01549041|FG001|Participant Flow|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
11094032|NCT01549041|OG000|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
11094033|NCT01549041|OG001|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
11094034|NCT01549041|EG000|Reported Event|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
11094035|NCT01549041|EG001|Reported Event|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
11094036|NCT01549223|BG000|Baseline|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
11217727|NCT02316171|FG001|Participant Flow|CVA21/Mitomycin C|Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
11217728|NCT02316171|FG002|Participant Flow|A2 - CVA21 3x10^8 TCID50.|CAVATAK was administered at 3x10^8 TCID50
11094037|NCT01549223|BG001|Baseline|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
11094038|NCT01549223|BG002|Baseline|Total|Total of all reporting groups
11094039|NCT01549223|FG000|Participant Flow|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (Intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
11094040|NCT01549223|FG001|Participant Flow|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM (Intramuscular).~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
11094041|NCT01549223|OG000|Outcome|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
11094042|NCT01549223|OG001|Outcome|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
11094043|NCT01549223|EG000|Reported Event|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
11094044|NCT01549223|EG001|Reported Event|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).~If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.~If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.~If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.~Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
11094045|NCT01549275|BG000|Baseline|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
11094046|NCT01549275|BG001|Baseline|AJCC TNM Staging > = IIIB HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
11094047|NCT01549275|BG002|Baseline|Total|Total of all reporting groups
11094048|NCT01549275|FG000|Participant Flow|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
11094049|NCT01549275|FG001|Participant Flow|AJCC TNM Staging > = IIIB HCC Patients|29 patients belonged to AJCC TNM staging > = IIIB.
10826957|NCT00106704|BG000|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
11094050|NCT01549275|OG000|Outcome|AJCC TNM Staging > = IIIB|
11094051|NCT01549275|OG001|Outcome|AJCC TNM Staging < = IIIA HCC Patients|
11094052|NCT01549275|OG000|Outcome|TNM Staging < = IIIA Patients Receiving Curative Treatment|All patient belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree A (14 patients) or B (8 patients).
11094053|NCT01549275|OG001|Outcome|TNM Staging < = IIIA Patients Receiving TACE|All patients belonged to Child A classification and BCLC(Barcelona Clinic Liver Cancer classification) degree A or B.
11094054|NCT01549275|OG002|Outcome|TNM Staging < = IIIA Patients Receiving Supportive Treatment|5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.
11094055|NCT01549275|OG003|Outcome|TNM Staging > = IIIB Patients Receiving TACE|All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.
11094056|NCT01549275|OG004|Outcome|TNM Staging > = IIIB Patients Receiving Supportive Treatment|All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
11094057|NCT01549275|EG000|Reported Event|HCC Patients Underwent FNA of Tumor|Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed.
11094058|NCT01549314|BG000|Baseline|Subjects With CF Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will be or have started taking ivacaftor within the previous 6 months
10826958|NCT00106704|BG001|Baseline|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826959|NCT00106704|BG002|Baseline|Total|Total of all reporting groups
11094059|NCT01549314|BG001|Baseline|Subjects With CF Not Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will not be taking ivacaftor, matched for age, race, and gender with cohort 1
11094060|NCT01549314|BG002|Baseline|Healthy Subjects|Healthy subjects with no medical conditions known to affect bone between the ages of 6 to 75 years old, matched for age, race, and gender with cohort 2.
11094061|NCT01549314|BG003|Baseline|Total|Total of all reporting groups
11094062|NCT01549314|FG000|Participant Flow|Subjects With CF Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will be or have started taking ivacaftor within the previous 6 months
11094063|NCT01549314|FG001|Participant Flow|Subjects With CF Not Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will not be taking ivacaftor, matched for age, race, and gender with cohort 1
11094064|NCT01549314|FG002|Participant Flow|Healthy Subjects|Healthy subjects with no medical conditions known to affect bone between the ages of 6 to 75 years old, matched for age, race, and gender with cohort 2.
11094065|NCT01549314|OG000|Outcome|Subjects With CF Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will be or have started taking ivacaftor within the previous 6 months
11094066|NCT01549314|OG001|Outcome|Subjects With CF Not Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will not be taking ivacaftor, matched for age, race, and gender with cohort 1
11094067|NCT01549314|OG002|Outcome|Healthy Subjects|Healthy subjects with no medical conditions known to affect bone between the ages of 6 to 75 years old, matched for age, race, and gender with cohort 2.
11094068|NCT01549314|EG000|Reported Event|Subjects With CF Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will be or have started taking ivacaftor within the previous 6 months
11094069|NCT01549314|EG001|Reported Event|Subjects With CF Not Taking Ivacaftor|Subjects with CF ages 6 to 75 years old who will not be taking ivacaftor, matched for age, race, and gender with cohort 1
11094070|NCT01549314|EG002|Reported Event|Healthy Subjects|Healthy subjects with no medical conditions known to affect bone between the ages of 6 to 75 years old, matched for age, race, and gender with cohort 2.
11094071|NCT01549340|BG000|Baseline|Participants With AR|Participants with AR whose records were retrospectively reviewed
11094072|NCT01549340|FG000|Participant Flow|Participants With AR|Participants with AR whose records were retrospectively reviewed
11094073|NCT01549340|OG000|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
11094074|NCT01549340|OG000|Outcome|Participants With AR Who Discontinued SCIT|Participants with AR whose records were retrospectively reviewed and discontinued SCIT
11094075|NCT01549340|OG001|Outcome|Participants With AR Who Discontinued SLIT|Participants with AR whose records were retrospectively reviewed and discontinued SLIT
11094076|NCT01549340|OG000|Outcome|Participants With AR and Asthma|Participants with AR and asthma whose records were retrospectively reviewed
11094077|NCT01549340|OG000|Outcome|Participants With AR and Asthma|Participants with AR and asthma who elected AIT and whose records were retrospectively reviewed
11094078|NCT01549340|OG001|Outcome|Participants With AR Alone|Participants with AR alone who elected AIT and whose records were retrospectively reviewed
11094079|NCT01549340|EG000|Reported Event|Participants With AR|Participants with AR whose records were retrospectively reviewed
11094080|NCT01549392|BG000|Baseline|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11313217|NCT03196297|EG003|Reported Event|Concizumab 0.15 mg/kg - Extension Part|Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313218|NCT03196297|EG004|Reported Event|Concizumab 0.20 mg/kg - Extension Part|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313219|NCT03196297|EG005|Reported Event|Concizumab 0.25 mg/kg - Extension Part|Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
11313220|NCT03196349|BG000|Baseline|Warfarin|"Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3~Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3"
11313221|NCT03196349|BG001|Baseline|Apixaban|"Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily~Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily"
11313222|NCT03196349|BG002|Baseline|Rivaroxaban|"Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily~Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily"
11313223|NCT03196349|BG003|Baseline|Total|Total of all reporting groups
11313224|NCT03196349|FG000|Participant Flow|Warfarin|"Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3~Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3"
11313225|NCT03196349|FG001|Participant Flow|Apixaban|"Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily~Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily"
11313226|NCT03196349|FG002|Participant Flow|Rivaroxaban|"Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily~Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily"
11313227|NCT03196349|OG000|Outcome|Warfarin|"Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3~Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3"
10826960|NCT00106704|FG000|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826961|NCT00106704|FG001|Participant Flow|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826962|NCT00106704|OG000|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
11313228|NCT03196349|OG001|Outcome|Apixaban|"Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily~Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily"
11313229|NCT03196349|OG002|Outcome|Rivaroxaban|"Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily~Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily"
11313230|NCT03196349|EG000|Reported Event|Warfarin|"Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3~Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3"
11313231|NCT03196349|EG001|Reported Event|Apixaban|"Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily~Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily"
11313232|NCT03196349|EG002|Reported Event|Rivaroxaban|"Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily~Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily"
11313233|NCT03196505|BG000|Baseline|Liposomal Bupivacaine|"Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11313234|NCT03196505|BG001|Baseline|Control|"60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11313235|NCT03196505|BG002|Baseline|Total|Total of all reporting groups
11313236|NCT03196505|FG000|Participant Flow|Liposomal Bupivacaine|"Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
10826963|NCT00106704|OG001|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826964|NCT00106704|EG000|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826965|NCT00106704|EG001|Reported Event|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
10826966|NCT00106938|BG000|Baseline|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826967|NCT00106938|BG001|Baseline|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826968|NCT00106938|BG002|Baseline|Total|Total of all reporting groups
10826969|NCT00106938|FG000|Participant Flow|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826970|NCT00106938|FG001|Participant Flow|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826971|NCT00106938|OG000|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826972|NCT00106938|OG001|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826973|NCT00106938|EG000|Reported Event|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826974|NCT00106938|EG001|Reported Event|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
10826975|NCT00106964|BG000|Baseline|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826976|NCT00106964|BG001|Baseline|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826977|NCT00106964|BG002|Baseline|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826978|NCT00106964|BG003|Baseline|Total|Total of all reporting groups
10826979|NCT00106964|FG000|Participant Flow|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826980|NCT00106964|FG001|Participant Flow|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826981|NCT00106964|FG002|Participant Flow|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826982|NCT00106964|OG000|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826983|NCT00106964|OG001|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826984|NCT00106964|OG002|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826985|NCT00106964|OG000|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
10826986|NCT00106964|OG001|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
10826987|NCT00106964|OG002|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
10826988|NCT00106964|OG000|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
10826989|NCT00106964|OG001|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
10826990|NCT00106964|OG002|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
10826991|NCT00106964|OG002|Outcome|3: Twindrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826992|NCT00106964|OG000|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826993|NCT00106964|OG001|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826994|NCT00106964|EG000|Reported Event|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826995|NCT00106964|EG001|Reported Event|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10826996|NCT00106964|EG002|Reported Event|3. Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
10848558|NCT00290433|OG000|Outcome|HCVIDDOXIL Regimen|"Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.~Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3."
11094081|NCT01549392|BG001|Baseline|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094082|NCT01549392|BG002|Baseline|Total|Total of all reporting groups
11094083|NCT01549392|FG000|Participant Flow|DECT/MRS in Patients Receiving Avastin|"3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks"
11094084|NCT01549392|FG001|Participant Flow|DECT/MRS in Glioma Patients Not Receiving Avastin|"0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094085|NCT01549392|OG000|Outcome|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094086|NCT01549392|OG001|Outcome|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094087|NCT01549392|EG000|Reported Event|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094088|NCT01549392|EG001|Reported Event|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
11094089|NCT01549405|BG000|Baseline|Control Group|Control group: Group that without intercostal nerve block
11094090|NCT01549405|BG001|Baseline|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
11094091|NCT01549405|BG002|Baseline|Total|Total of all reporting groups
11094092|NCT01549405|FG000|Participant Flow|Control Group|Control group: Group that without intercostal nerve block
11094093|NCT01549405|FG001|Participant Flow|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
11094094|NCT01549405|OG000|Outcome|Control|Group that without intercostal nerve block
11094095|NCT01549405|OG001|Outcome|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
11094096|NCT01549405|OG000|Outcome|Control Group|Control group: Group that without intercostal nerve block
11094097|NCT01549405|OG001|Outcome|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
11094098|NCT01549405|EG000|Reported Event|Control|Group that without intercostal nerve block
11094099|NCT01549405|EG001|Reported Event|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
11094100|NCT01549587|BG000|Baseline|Regular Oral Hygiene|"toothpaste, toothbrush and dental floss~0.243% sodium fluoride: dentifrice: brush thoroughly twice daily~toothbrush: brush thoroughly twice daily~dental floss: floss the whole mouth once daily"
11094101|NCT01549587|BG001|Baseline|Advanced Oral Hygiene Plus Counseling|"toothpaste, toothbrush, mouth rinse and dental floss plus specialized education~0.454% stannous fluoride: dentifrice: twice daily brush thoroughly for 2 minutes~toothbrush: twice daily brush thoroughly for 2 minutes~0.07% Cetylpyridinium chloride: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily~dental floss: floss the whole mouth once daily"
11094102|NCT01549587|BG002|Baseline|Total|Total of all reporting groups
11094103|NCT01549587|FG000|Participant Flow|Regular Oral Hygiene|"toothpaste, toothbrush and dental floss~0.243% sodium fluoride: dentifrice: brush thoroughly twice daily~toothbrush: brush thoroughly twice daily~dental floss: floss the whole mouth once daily"
11094104|NCT01549587|FG001|Participant Flow|Advanced Oral Hygiene Plus Counseling|"toothpaste, toothbrush, mouth rinse and dental floss plus specialized education~0.454% stannous fluoride: dentifrice: twice daily brush thoroughly for 2 minutes~toothbrush: twice daily brush thoroughly for 2 minutes~0.07% Cetylpyridinium chloride: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily~dental floss: floss the whole mouth once daily"
11094105|NCT01549587|OG000|Outcome|Regular Oral Hygiene|"toothpaste, toothbrush and dental floss~0.243% sodium fluoride: dentifrice: brush thoroughly twice daily~toothbrush: brush thoroughly twice daily~dental floss: floss the whole mouth once daily"
11094106|NCT01549587|OG001|Outcome|Advanced Oral Hygiene Plus Counseling|"toothpaste, toothbrush, mouth rinse and dental floss plus specialized education~0.454% stannous fluoride: dentifrice: twice daily brush thoroughly for 2 minutes~toothbrush: twice daily brush thoroughly for 2 minutes~0.07% Cetylpyridinium chloride: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily~dental floss: floss the whole mouth once daily"
11094107|NCT01549587|EG000|Reported Event|Regular Oral Hygiene|"toothpaste, toothbrush and dental floss~0.243% sodium fluoride: dentifrice: brush thoroughly twice daily~toothbrush: brush thoroughly twice daily~dental floss: floss the whole mouth once daily"
11094108|NCT01549587|EG001|Reported Event|Advanced Oral Hygiene Plus Counseling|"toothpaste, toothbrush, mouth rinse and dental floss plus specialized education~0.454% stannous fluoride: dentifrice: twice daily brush thoroughly for 2 minutes~toothbrush: twice daily brush thoroughly for 2 minutes~0.07% Cetylpyridinium chloride: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily~dental floss: floss the whole mouth once daily"
11217729|NCT02316171|FG003|Participant Flow|A3 - CVA21 3x10^8 TCID50 x2|CAVATAK was administered at 3x10^8 TCID50 twice.
11217730|NCT02316171|OG000|Outcome|CVA21|CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules
10826997|NCT00107042|BG000|Baseline|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
10826998|NCT00107042|BG001|Baseline|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
10826999|NCT00107042|BG002|Baseline|Total|Total of all reporting groups
10827000|NCT00107042|FG000|Participant Flow|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
10827001|NCT00107042|FG001|Participant Flow|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
10827002|NCT00107042|OG000|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
10827003|NCT00107042|OG001|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
10827004|NCT00107042|OG000|Outcome|All Participants|All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
10827005|NCT00107042|OG000|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
10827006|NCT00107042|OG000|Outcome|Other Sites|All other clinical sites (besides the Baltimore site) where subjects were enrolled.
10827007|NCT00107042|OG001|Outcome|Baltimore|Clinical site where subjects were enrolled.
10827008|NCT00107042|OG000|Outcome|15-17 Years of Age|Subjects between the ages of 15 and 17 years, inclusive
10827009|NCT00107042|OG001|Outcome|12-14 Years of Age|Subjects between the ages of 12 and 14 years, inclusive
10827010|NCT00107042|OG000|Outcome|Female|Female Subjects
10827011|NCT00107042|OG001|Outcome|Male|Male Subjects
10827012|NCT00107042|OG000|Outcome|Not Hispanic|Subjects who reported they were not of Hispanic ethnicity.
10827013|NCT00107042|OG001|Outcome|Hispanic|Subjects who reported they were of Hispanic ethnicity.
10827014|NCT00107042|OG000|Outcome|White|Subjects who reported their race to be white.
10827015|NCT00107042|OG001|Outcome|Other/Mixed Race|Subjects who reported their race to be other than white, black, or of mixed race.
10827016|NCT00107042|OG002|Outcome|Black/African American|Subjects who reported their race to be black or African American
10827017|NCT00107042|OG000|Outcome|Tanner Stage 5 (Females)|Females who were self-assessed and categorized to Tanner Stage 5.
10827018|NCT00107042|OG001|Outcome|Tanner Stages 1-4 (Females)|Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
10827019|NCT00107042|OG000|Outcome|Tanner Stage 5 (Males)|Males who were self-assessed and categorized to Tanner Stage 5.
10827020|NCT00107042|OG001|Outcome|Tanner Stages 1-4 (Males)|Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
10827021|NCT00107042|OG000|Outcome|Normal and Underweight (< 25.0)|Subjects whose BMIs were normal to < 25.0
10827022|NCT00107042|OG001|Outcome|Overweight and Obese (>=25.0)|Subjects whose BMIs were >= 25.0
10827023|NCT00107042|OG000|Outcome|Ever Smoked Cigarettes: NO|Subjects who have never smoked cigarettes
10827024|NCT00107042|OG001|Outcome|Ever Smoked Cigarettes: YES|Subjects who have smoked cigarettes
10827025|NCT00107042|OG000|Outcome|Straight (Heterosexual)|Subjects who were straight (heterosexual)
10827026|NCT00107042|OG001|Outcome|Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided|Subjects who were either gay (homosexual), bisexual, not sure or undecided.
10827027|NCT00107042|OG000|Outcome|Never|Subjects who reported they never had anal or vaginal sex because they wanted to.
10827028|NCT00107042|OG001|Outcome|12-14 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
10827029|NCT00107042|OG002|Outcome|15-17 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
10827030|NCT00107042|OG000|Outcome|0 Sex Partners|Subjects who have never had a sex partner
10827031|NCT00107042|OG001|Outcome|1 - 5 Sex Partners|Subjects who have had 1 - 5 lifetime sex partners
10827032|NCT00107042|OG002|Outcome|>= 6 Sex Partners|Subjects who have had 6 or more lifetime sex partners
10827033|NCT00107042|OG000|Outcome|0 Male Sex Partners|Male and female subjects who have never had a male sex partner
10827034|NCT00107042|OG001|Outcome|1-5 Male Sex Partners|Male and female subjects who have had 1 - 5 lifetime male sex partners
10827035|NCT00107042|OG002|Outcome|>= 6 Male Sex Partners|Male and female subjects who have had 6 or more lifetime male sex partners
10827036|NCT00107042|OG000|Outcome|0 Female Sex Partners|Male and female subjects who have never had a female sex partner
10827037|NCT00107042|OG001|Outcome|1-5 Female Sex Partners|Male and female Subjects who have had 1 - 5 lifetime female sex partners
10827038|NCT00107042|OG002|Outcome|>= 6 Female Sex Partners|Male and female subjects who have had 6 or more lifetime female sex partners
10827039|NCT00107042|OG000|Outcome|Ever Drank Alcohol: NO|Subjects who have never drank alcohol
10827040|NCT00107042|OG001|Outcome|Ever Drank Alcohol: YES|Subjects who have drank alcohol
10827041|NCT00107042|OG000|Outcome|Ever Smoked Marijuana: NO|Subjects who have never smoked marijuana
10827042|NCT00107042|OG001|Outcome|Ever Smoked Marijuana: YES|Subjects who have smoked marijuana
10827043|NCT00107042|OG000|Outcome|Ever Used Drugs Not Prescribed: NO|Subjects who have never used drugs that were not prescribed.
10827044|NCT00107042|OG001|Outcome|Ever Used Drugs Not Prescribed: YES|Subjects who have used drugs that were not prescribed.
10827045|NCT00107042|OG000|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
10827046|NCT00107042|EG000|Reported Event|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
10827047|NCT00107042|EG001|Reported Event|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
10827048|NCT00107120|BG000|Baseline|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
10827049|NCT00107120|BG001|Baseline|Placebo|Once daily oral administration of placebo tablets
10827050|NCT00107120|BG002|Baseline|Total|Total of all reporting groups
10827051|NCT00107120|FG000|Participant Flow|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
10827052|NCT00107120|FG001|Participant Flow|Placebo|Once daily oral administration of placebo tablets
10827053|NCT00107120|OG000|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
10827054|NCT00107120|OG001|Outcome|Placebo|Once daily oral administration of placebo tablets
10827055|NCT00107120|EG000|Reported Event|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
10827056|NCT00107120|EG001|Reported Event|Placebo|Once daily oral administration of placebo tablets
10827057|NCT00107172|BG000|Baseline|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
10827058|NCT00107172|BG001|Baseline|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
10827059|NCT00107172|BG002|Baseline|Total|Total of all reporting groups
10827060|NCT00107172|FG000|Participant Flow|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
10827061|NCT00107172|FG001|Participant Flow|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
10827062|NCT00107172|OG000|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
10827063|NCT00107172|OG001|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
10827064|NCT00107172|EG000|Reported Event|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
10827065|NCT00107172|EG001|Reported Event|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
10827066|NCT00107198|BG000|Baseline|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
10827067|NCT00107198|FG000|Participant Flow|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
10827068|NCT00107198|OG000|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
10827069|NCT00107198|EG000|Reported Event|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
10827070|NCT00107276|BG000|Baseline|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
10827071|NCT00107276|FG000|Participant Flow|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
10827072|NCT00107276|OG000|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
10827073|NCT00107276|OG000|Outcome|Cyclophosphamide and Capecitabine|
10827074|NCT00107276|EG000|Reported Event|Cyclophosphamide and Capecitabine|
10827075|NCT00107380|BG000|Baseline|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
10827076|NCT00107380|FG000|Participant Flow|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
10827077|NCT00107380|OG000|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
10827078|NCT00107380|OG000|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
10827079|NCT00107380|EG000|Reported Event|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
10827080|NCT00107536|BG000|Baseline|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
10827081|NCT00107536|FG000|Participant Flow|Lapatinib|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
10827082|NCT00107536|OG000|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
10827083|NCT00107536|EG000|Reported Event|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
10827084|NCT00107575|BG000|Baseline|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
10827085|NCT00107575|BG001|Baseline|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
10827086|NCT00107575|BG002|Baseline|Total|Total of all reporting groups
10827087|NCT00107575|FG000|Participant Flow|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
10827088|NCT00107575|FG001|Participant Flow|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
10827089|NCT00107575|OG000|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
10827090|NCT00107575|OG001|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
10827091|NCT00107575|EG000|Reported Event|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
10827092|NCT00107575|EG001|Reported Event|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
10827093|NCT00107653|BG000|Baseline|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
10827094|NCT00107653|BG001|Baseline|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
10827095|NCT00107653|BG002|Baseline|Total|Total of all reporting groups
10827096|NCT00107653|FG000|Participant Flow|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
10827097|NCT00107653|FG001|Participant Flow|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
10827098|NCT00107653|OG000|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
10827099|NCT00107653|OG001|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
10827100|NCT00107653|EG000|Reported Event|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
10827101|NCT00107653|EG001|Reported Event|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
10827102|NCT00107744|BG000|Baseline|Soy Protein-milk Protein-carbohydrate|Participants received 40 grams of soy protein daily for 8 weeks, 40 grams of milk protein daily for 8 weeks, and 40 grams of carbohydrate daily for 8 weeks.
10827103|NCT00107744|BG001|Baseline|Milk Protein-carbohydrate-soy Protein|Participants received 40 grams of milk protein daily for 8 weeks, 40 grams of carbohydrate daily for 8 weeks, and 40 grams of soy protein daily for 8 weeks.
10827104|NCT00107744|BG002|Baseline|Carbohydrate-soy Protein-milk Protein|Participants received 40 grams of complex carbohydrate daily for 8 weeks, 40 grams of soy protein daily for 8 weeks, and 40 grams of milk protein daily for 8 weeks.
10827105|NCT00107744|BG003|Baseline|Total|Total of all reporting groups
10827106|NCT00107744|FG000|Participant Flow|Soy Protein-milk Protein-carbohydrate|Participants received 40 grams of soy protein daily for 8 weeks, 40 grams of milk protein daily for 8 weeks, and 40 grams of carbohydrate daily for 8 weeks.
10827107|NCT00107744|FG001|Participant Flow|Milk Protein-carbohydrate-soy Protein|Participants received 40 grams of milk protein daily for 8 weeks, 40 grams of carbohydrate daily for 8 weeks, and 40 grams of soy protein daily for 8 weeks.
10827108|NCT00107744|FG002|Participant Flow|Carbohydrate-soy Protein-milk Protein|Participants received 40 grams of complex carbohydrate daily for 8 weeks, 40 grams of soy protein daily for 8 weeks, and 40 grams of milk protein daily for 8 weeks.
10827109|NCT00107744|OG000|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
10827110|NCT00107744|OG001|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
10827111|NCT00107744|OG002|Outcome|Carbohydrate Supplementation|Cross-over analysis of milk protein supplementation
10827112|NCT00107744|EG000|Reported Event|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
10827113|NCT00107744|EG001|Reported Event|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
10827114|NCT00107744|EG002|Reported Event|Carbohydrate Supplementation|Cross-over analysis of milk protein supplementation
10827115|NCT00107783|BG000|Baseline|Control|No treatment
10827116|NCT00107783|BG001|Baseline|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
10827117|NCT00107783|BG002|Baseline|Total|Total of all reporting groups
10827118|NCT00107783|FG000|Participant Flow|Control|No treatment
10827119|NCT00107783|FG001|Participant Flow|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
10827120|NCT00107783|OG000|Outcome|Control|No treatment
10827121|NCT00107783|OG001|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
10827122|NCT00107783|EG000|Reported Event|Control|No treatment
10827123|NCT00107783|EG001|Reported Event|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
10827124|NCT00107900|BG000|Baseline|15mg BID|15mg edoxaban administered twice daily (BID)
10827125|NCT00107900|BG001|Baseline|30mg QD|30mg edoxaban administered once daily (QD)
10827126|NCT00107900|BG002|Baseline|30mg BID|30mg edoxaban administered twice daily (BID)
10827127|NCT00107900|BG003|Baseline|60mg QD|60mg edoxaban administered once daily (QD)
10827128|NCT00107900|BG004|Baseline|60mg BID|60mg edoxaban administered twice daily (BID)
10827129|NCT00107900|BG005|Baseline|120mg QD|120mg edoxaban administered once daily (QD)
10827130|NCT00107900|BG006|Baseline|Total|Total of all reporting groups
10827131|NCT00107900|FG000|Participant Flow|15mg BID|15mg edoxaban administered twice daily (BID)
10827132|NCT00107900|FG001|Participant Flow|30mg QD|30mg edoxaban administered once daily (QD)
10827133|NCT00107900|FG002|Participant Flow|30mg BID|30mg edoxaban administered twice daily (BID)
10827134|NCT00107900|FG003|Participant Flow|60mg QD|60mg edoxaban administered once daily (QD)
10827135|NCT00107900|FG004|Participant Flow|60mg BID|60mg edoxaban administered twice daily (BID)
10827136|NCT00107900|FG005|Participant Flow|120mg QD|120mg edoxaban administered once daily (QD)
10827137|NCT00107900|OG000|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
10827138|NCT00107900|OG001|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
10827139|NCT00107900|OG002|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
11094109|NCT01549613|BG000|Baseline|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
11094110|NCT01549613|BG001|Baseline|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
11094111|NCT01549613|BG002|Baseline|Total|Total of all reporting groups
11094112|NCT01549613|FG000|Participant Flow|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
11094113|NCT01549613|FG001|Participant Flow|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
11094114|NCT01549613|OG000|Outcome|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
11094115|NCT01549613|OG001|Outcome|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
11094116|NCT01549613|EG000|Reported Event|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
11094117|NCT01549613|EG001|Reported Event|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
11094118|NCT01549652|BG000|Baseline|Prevention of Opioid Withdrawal|"Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week.~Data regarding how many participants received ondansetron first versus placebo first are not accessible."
11094119|NCT01549652|BG001|Baseline|Prevention of Physical Dependence-Ondansetron|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094120|NCT01549652|BG002|Baseline|Prevention of Physical Dependence-Placebo|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094121|NCT01549652|BG003|Baseline|Total|Total of all reporting groups
11094122|NCT01549652|FG000|Participant Flow|Prevention of Opioid Withdrawal-Ondansetron|"Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week.~Data regarding how many participants received ondansetron first versus placebo first are not accessible."
11094123|NCT01549652|FG001|Participant Flow|Prevention of Opioid Withdrawal-Placebo|"Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week.~Data regarding how many participants received ondansetron first versus placebo first are not accessible."
11217731|NCT02316171|OG001|Outcome|CVA21/Mitomycin C|Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
11217732|NCT02316171|EG000|Reported Event|CVA21|CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules
11094124|NCT01549652|FG002|Participant Flow|Prevention of Physical Dependence - Ondansetron|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094125|NCT01549652|FG003|Participant Flow|Prevention of Physical Dependence - Placebo|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094126|NCT01549652|OG000|Outcome|Prevention of Opioid Withdrawal|Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week.
11094127|NCT01549652|OG000|Outcome|Prevention of Physical Dependence|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094128|NCT01549652|EG000|Reported Event|Prevention of Opioid Withdrawal|Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week.
11094129|NCT01549652|EG001|Reported Event|Prevention of Physical Dependence|Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week.
11094130|NCT01549860|BG000|Baseline|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
11094131|NCT01549860|BG001|Baseline|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
11094132|NCT01549860|BG002|Baseline|Total|Total of all reporting groups
11094133|NCT01549860|FG000|Participant Flow|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
11094134|NCT01549860|FG001|Participant Flow|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
11094135|NCT01549860|OG000|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
11094136|NCT01549860|OG001|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
11094137|NCT01549860|EG000|Reported Event|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
11094138|NCT01549860|EG001|Reported Event|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
11094139|NCT01549873|BG000|Baseline|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
11094140|NCT01549873|BG001|Baseline|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
11094141|NCT01549873|BG002|Baseline|Total|Total of all reporting groups
11094142|NCT01549873|FG000|Participant Flow|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
10827140|NCT00107900|OG003|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
10827141|NCT00107900|OG004|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
11094143|NCT01549873|FG001|Participant Flow|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
11094144|NCT01549873|OG000|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
11094145|NCT01549873|OG001|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
11094146|NCT01549873|EG000|Reported Event|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
11094147|NCT01549873|EG001|Reported Event|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
11094148|NCT01549886|BG000|Baseline|MGD+Rituximab+Zevalin|"Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL."
11094149|NCT01549886|BG001|Baseline|Rituximab+Zevalin|Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
11094150|NCT01549886|BG002|Baseline|Total|Total of all reporting groups
11094151|NCT01549886|FG000|Participant Flow|MGD+Rituximab+Y-90-Zevalin|"Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL."
10827142|NCT00107900|OG005|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
11094152|NCT01549886|FG001|Participant Flow|Rituximab+Y-90-Zevalin|Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
11094153|NCT01549886|OG000|Outcome|MGD+Rituximab+Y-90-Zevalin|"Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL."
11094154|NCT01549886|OG001|Outcome|Rituximab+Y-90-Zevalin|"Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)~Zevalin Regimen: Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push"
11094155|NCT01549886|OG000|Outcome|MGD+Rituximab+Zevalin|"Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL."
11094156|NCT01549886|OG001|Outcome|Rituximab+Zevalin|Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
11094157|NCT01549886|EG000|Reported Event|MGD+Rituximab+Y-90-Zevalin|"Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL."
11094158|NCT01549886|EG001|Reported Event|Rituximab+Y-90-Zevalin|"Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)~Zevalin Regimen: Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push"
11094159|NCT01549925|BG000|Baseline|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
11094160|NCT01549925|BG001|Baseline|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
11094161|NCT01549925|BG002|Baseline|Total|Total of all reporting groups
11094162|NCT01549925|FG000|Participant Flow|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
11094163|NCT01549925|FG001|Participant Flow|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
11094164|NCT01549925|OG000|Outcome|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
11094165|NCT01549925|OG001|Outcome|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
11094166|NCT01549925|EG000|Reported Event|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
11094167|NCT01549925|EG001|Reported Event|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
11217733|NCT02316171|EG001|Reported Event|CVA21/Mitomycin C|Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
11217734|NCT02316223|BG000|Baseline|Usual Care|Clinician-centric strategy and EMR-based clinician decision support
11217735|NCT02316223|BG001|Baseline|Home-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217736|NCT02316223|BG002|Baseline|Clinic-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217737|NCT02316223|BG003|Baseline|Total|Total of all reporting groups
11217738|NCT02316223|FG000|Participant Flow|Clinic-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217739|NCT02316223|FG001|Participant Flow|Home-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217740|NCT02316223|FG002|Participant Flow|Usual Care|Clinician-centric strategy and EMR-based clinician decision support
11217741|NCT02316223|OG000|Outcome|Home-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217742|NCT02316223|OG001|Outcome|Clinic-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217743|NCT02316223|OG002|Outcome|Usual Care|Clinician-centric strategy and EMR-based clinician decision support
11217744|NCT02316223|EG000|Reported Event|Home-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217745|NCT02316223|EG001|Reported Event|Clinic-based Care Coordination|Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
11217746|NCT02316223|EG002|Reported Event|Usual Care|Clinician-centric strategy and EMR-based clinician decision support
11217747|NCT02316353|BG000|Baseline|CSL830 (40)|A low-volume dose of C1-INH (40 IU/kg) administered subcutaneously twice a week
11217748|NCT02316353|BG001|Baseline|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week
11217749|NCT02316353|BG002|Baseline|Total|Total of all reporting groups
11217750|NCT02316353|FG000|Participant Flow|CSL830 (40)|A low-volume dose of C1-INH (40 IU/kg) administered subcutaneously twice a week
11217751|NCT02316353|FG001|Participant Flow|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week
11217752|NCT02316353|OG000|Outcome|CSL830 (40)|A low-volume dose of C1-INH (40 IU/kg) administered subcutaneously twice a week
11217753|NCT02316353|OG001|Outcome|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week
11217754|NCT02316353|OG001|Outcome|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week. Actual n=70 for the high volume dose because 7 subjects titrated up from the 40 IU/kg arm and will be displayed in both arms.
11217755|NCT02316353|OG001|Outcome|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week. Note: Actual n=70 for the high volume dose because 7 subjects titrated up from the 40 IU/kg arm and will be displayed in both arms.
11217756|NCT02316353|OG001|Outcome|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week. Actual n= 70 because 7 subjects titrated up from the 40IU/kg arm and will be displayed in both arms.
11217757|NCT02316353|EG000|Reported Event|CSL830 (40)|A low-volume dose of C1-INH (40 IU/kg) administered subcutaneously twice a week
11217758|NCT02316353|EG001|Reported Event|CSL830 (60)|A high-volume dose of C1-INH (60 IU/kg) administered subcutaneously twice a week
11217759|NCT02316366|BG000|Baseline|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11217760|NCT02316366|BG001|Baseline|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11217761|NCT02316366|BG002|Baseline|Total|Total of all reporting groups
11094168|NCT01549951|BG000|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
11094169|NCT01549951|FG000|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
11094170|NCT01549951|OG000|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
11094171|NCT01549951|EG000|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
11094172|NCT01549964|BG000|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094173|NCT01549964|BG001|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094174|NCT01549964|BG002|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094175|NCT01549964|BG003|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094176|NCT01549964|BG004|Baseline|Total|Total of all reporting groups
11094177|NCT01549964|FG000|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094178|NCT01549964|FG001|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094179|NCT01549964|FG002|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094180|NCT01549964|FG003|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094181|NCT01549964|OG000|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094182|NCT01549964|OG001|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094183|NCT01549964|OG002|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094184|NCT01549964|OG003|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11217762|NCT02316366|FG000|Participant Flow|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11094185|NCT01549964|EG000|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094186|NCT01549964|EG001|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094187|NCT01549964|EG002|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094188|NCT01549964|EG003|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
11094189|NCT01550224|BG000|Baseline|Participant Group 1 (Methylated MGMT Promoter)|"Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days. Group 2 participants also receive at protracted, pre-induction treatment with 100 mg/m²/day for 14 days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094190|NCT01550224|BG001|Baseline|Participant Group 2 (Non-methylated MGMT Promoter)|"Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094191|NCT01550224|BG002|Baseline|Total|Total of all reporting groups
11094192|NCT01550224|FG000|Participant Flow|Participant Group 1 (Methylated MGMT Promoter)|"Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days. Group 2 participants also receive at protracted, pre-induction treatment with 100 mg/m²/day for 14 days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094193|NCT01550224|FG001|Participant Flow|Participant Group 2 (Non-methylated MGMT Promoter)|"Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094194|NCT01550224|OG000|Outcome|Participant Group 1 (Methylated MGMT Promoter)|"Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days. Group 2 participants also receive at protracted, pre-induction treatment with 100 mg/m²/day for 14 days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094195|NCT01550224|OG001|Outcome|Participant Group 2 (Non-methylated MGMT Promoter)|"Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11217763|NCT02316366|FG001|Participant Flow|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11217764|NCT02316366|OG000|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11217765|NCT02316366|OG001|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11094196|NCT01550224|EG000|Reported Event|Participant Group 1 (Methylated MGMT Promoter)|"Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days. Group 2 participants also receive at protracted, pre-induction treatment with 100 mg/m²/day for 14 days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094197|NCT01550224|EG001|Reported Event|Participant Group 2 (Non-methylated MGMT Promoter)|"Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).~Temozolomide: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.~Vorinostat: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day."
11094198|NCT01550341|BG000|Baseline|Buprenorphine|Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094199|NCT01550341|BG001|Baseline|Placebo|Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094200|NCT01550341|BG002|Baseline|Total|Total of all reporting groups
11094201|NCT01550341|FG000|Participant Flow|Buprenorphine|Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094202|NCT01550341|FG001|Participant Flow|Placebo|Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094203|NCT01550341|OG000|Outcome|Buprenorphine|Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094204|NCT01550341|OG001|Outcome|Placebo|Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094205|NCT01550341|EG000|Reported Event|Buprenorphine|Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094206|NCT01550341|EG001|Reported Event|Placebo|Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
11094207|NCT01550367|BG000|Baseline|Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d."
11094208|NCT01550367|FG000|Participant Flow|Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients)."
11094209|NCT01550367|OG000|Outcome|Hydroxychloroquine + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d."
11094210|NCT01550367|OG000|Outcome|Hydroxychloroquine + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses."
11094211|NCT01550367|OG000|Outcome|Hydroxychloroquine + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses."
11094212|NCT01550367|OG000|Outcome|Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2|"One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d."
11094213|NCT01550367|OG000|Outcome|Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2|"One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients)."
11094214|NCT01550367|EG000|Reported Event|Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d (initial (13) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients)."
11094215|NCT01550367|EG001|Reported Event|Hydroxychloroquine (HCQ) (600 mg/d) + IL-2|"One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.~Hydroxychloroquine: Continuous oral administration at 600 mg/d (17 patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.~IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course~Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients)."
11094216|NCT01550471|BG000|Baseline|All Study Participants|
11094217|NCT01550471|FG000|Participant Flow|A and O, Then Q and B, Then P and P|Treatment Order: Alvesco and Omnaris; QVAR and Beconase; Placebo and Placebo
11094218|NCT01550471|FG001|Participant Flow|A and O, Then P and P, Then Q and B|Treatment Order: Alvesco and Omnaris; Placebo and Placebo; QVAR and Beconase
11094219|NCT01550471|FG002|Participant Flow|Q and B, Then A and O, Then P and P|Treatment Order: QVAR and Beconase; Alvesco and Omnaris; Placebo and Placebo
11094220|NCT01550471|FG003|Participant Flow|Q and B, Then P and P, Then A and O|Treatment Order: Qvar and Beconase; Placebo and Placebo; Alvesco and Omnaris
11094221|NCT01550471|FG004|Participant Flow|P and P, Then A and O, Then Q and B|Treatment Order: Placebo and Placebo; Alvesco and Omnaris; Qvar and Beconase
11094222|NCT01550471|FG005|Participant Flow|P and P, Then Q and B, Then A and O|Treatment Order: Placebo and Placebo; Qvar and Beconase; Alvesco and Omnaris
11094223|NCT01550471|OG000|Outcome|Alvesco and Omnaris|
11094224|NCT01550471|OG001|Outcome|Beconase and QVAR|
11094225|NCT01550471|OG000|Outcome|Omnaris & Alvesco|
11094226|NCT01550471|OG001|Outcome|Placebo & Placebo|
11094227|NCT01550471|EG000|Reported Event|Alvesco and Omnaris|
11094228|NCT01550471|EG001|Reported Event|Qvar and Beconase|
11094229|NCT01550471|EG002|Reported Event|Placebo and Placebo|
11094230|NCT01550549|BG000|Baseline|Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
11094231|NCT01550549|FG000|Participant Flow|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
11094232|NCT01550549|OG000|Outcome|Florbetapir-PET Scans Primary Analysis Group|
11094233|NCT01550549|OG000|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
11094234|NCT01550549|OG001|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
11094235|NCT01550549|OG000|Outcome|All Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan
11094236|NCT01550549|OG000|Outcome|All Autopsy Population|
10827143|NCT00107900|EG000|Reported Event|15mg BID|15mg edoxaban administered twice daily (BID)
11094237|NCT01550549|OG000|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 year of scan
11094238|NCT01550549|OG000|Outcome|Autopsy Within One Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
11094239|NCT01550549|EG000|Reported Event|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
11094240|NCT01550705|BG000|Baseline|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
11094241|NCT01550705|FG000|Participant Flow|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
11094242|NCT01550705|OG000|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
11094243|NCT01550705|EG000|Reported Event|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
11094244|NCT01550731|BG000|Baseline|PREPARE|"The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.~PREPARE website: Advance care planning website and materials plus an advance directive."
11094245|NCT01550731|BG001|Baseline|CONTROL|"The control group will only receive an advance directive.~Advance directive: The control group will only receive an advance directive."
11094246|NCT01550731|BG002|Baseline|Total|Total of all reporting groups
11094247|NCT01550731|FG000|Participant Flow|PREPARE|"The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.~PREPARE website: Advance care planning website and materials plus an advance directive."
11094248|NCT01550731|FG001|Participant Flow|CONTROL|"The control group will only receive an advance directive.~Advance directive: The control group will only receive an advance directive."
11094249|NCT01550731|OG000|Outcome|PREPARE|"The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.~PREPARE website: Advance care planning website and materials plus an advance directive."
11094250|NCT01550731|OG001|Outcome|CONTROL|"The control group will only receive an advance directive.~Advance directive: The control group will only receive an advance directive."
11094251|NCT01550731|EG000|Reported Event|PREPARE|"The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.~PREPARE website: Advance care planning website and materials plus an advance directive."
11094252|NCT01550731|EG001|Reported Event|CONTROL|"The control group will only receive an advance directive.~Advance directive: The control group will only receive an advance directive."
11094253|NCT01550744|BG000|Baseline|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
11094254|NCT01550744|FG000|Participant Flow|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
11094255|NCT01550744|FG001|Participant Flow|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
11094256|NCT01550744|FG002|Participant Flow|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
11094257|NCT01550744|OG000|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
11094258|NCT01550744|OG001|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
11094259|NCT01550744|EG000|Reported Event|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
11094260|NCT01550744|EG001|Reported Event|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
11094261|NCT01550744|EG002|Reported Event|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
11094262|NCT01550757|BG000|Baseline|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
11094263|NCT01550757|BG001|Baseline|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094264|NCT01550757|BG002|Baseline|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
11094265|NCT01550757|BG003|Baseline|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094266|NCT01550757|BG004|Baseline|Total|Total of all reporting groups
11094267|NCT01550757|FG000|Participant Flow|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
11094268|NCT01550757|FG001|Participant Flow|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094269|NCT01550757|FG002|Participant Flow|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
11094270|NCT01550757|FG003|Participant Flow|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094271|NCT01550757|OG000|Outcome|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
11094272|NCT01550757|OG001|Outcome|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094273|NCT01550757|OG002|Outcome|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
11094274|NCT01550757|OG003|Outcome|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094275|NCT01550757|EG000|Reported Event|Arm 1: Normal PACT Clinical Care|Normal Patient Aligned Care Team Clinical Care
11094276|NCT01550757|EG001|Reported Event|Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor|"Normal PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094277|NCT01550757|EG002|Reported Event|Arm 3: Normal Homeless Oriented PACT Clinical Care|Normal Homeless Oriented Patient Aligned Care Team Clinical Care
11094278|NCT01550757|EG003|Reported Event|Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded|"Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor~Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research."
11094279|NCT01550809|BG000|Baseline|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
11094280|NCT01550809|BG001|Baseline|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
11094281|NCT01550809|BG002|Baseline|Total|Total of all reporting groups
11094282|NCT01550809|FG000|Participant Flow|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
11094283|NCT01550809|FG001|Participant Flow|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
11094284|NCT01550809|OG000|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
11094285|NCT01550809|OG001|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
11094286|NCT01550809|EG000|Reported Event|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
11094287|NCT01550809|EG001|Reported Event|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
11094288|NCT01550952|BG000|Baseline|Total Shoulder Arthroplasty Patients|
11094289|NCT01550952|FG000|Participant Flow|Total Shoulder Arthroplasty Patients|
11094290|NCT01550952|OG000|Outcome|Total Shoulder Arthroplasty Patients|
11094291|NCT01550952|EG000|Reported Event|Total Shoulder Arthroplasty Patients|
11094292|NCT01550965|BG000|Baseline|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
11094293|NCT01550965|FG000|Participant Flow|Participants Receiving Adalimumab|Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
11094294|NCT01550965|OG000|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
11094295|NCT01550965|OG000|Outcome|Participants Receiving Adalimumab|"Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.~Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection"
11094296|NCT01550965|EG000|Reported Event|PARTICIPANTS RECEIVING ADALIMUMAB|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
11094297|NCT01551030|BG000|Baseline|Buparlisib|"This is an open-label phase II study of the pan-class I selective phosphoinositide 3-kinase (PI3K) inhibitor Buparlisib in patients with metastatic urothelial carcinoma which has progressed despite treatment with prior cytotoxic chemotherapy.~Buparlisib: Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression."
11094298|NCT01551030|FG000|Participant Flow|Buparlisib|"This is an open-label phase II study of the pan-class I selective phosphoinositide 3-kinase (PI3K) inhibitor Buparlisib in patients with metastatic urothelial carcinoma which has progressed despite treatment with prior cytotoxic chemotherapy.~Buparlisib: Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression."
11094299|NCT01551030|OG000|Outcome|Buparlisib|"This is an open-label phase II study of the pan-class I selective phosphoinositide 3-kinase (PI3K) inhibitor Buparlisib in patients with metastatic urothelial carcinoma which has progressed despite treatment with prior cytotoxic chemotherapy.~Buparlisib: Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression."
11094300|NCT01551030|EG000|Reported Event|Buparlisib|"This is an open-label phase II study of the pan-class I selective phosphoinositide 3-kinase (PI3K) inhibitor Buparlisib in patients with metastatic urothelial carcinoma which has progressed despite treatment with prior cytotoxic chemotherapy.~Buparlisib: Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression."
11094301|NCT01551056|BG000|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11094302|NCT01551056|BG001|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11094303|NCT01551056|BG002|Baseline|Total|Total of all reporting groups
11094304|NCT01551056|FG000|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11094305|NCT01551056|FG001|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11094306|NCT01551056|OG000|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11094307|NCT01551056|OG001|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11094308|NCT01551056|EG000|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
11094309|NCT01551056|EG001|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
11094310|NCT01551095|BG000|Baseline|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
11094311|NCT01551095|FG000|Participant Flow|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
11094312|NCT01551095|OG000|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
11094313|NCT01551095|EG000|Reported Event|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
11094314|NCT01551173|BG000|Baseline|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
11094315|NCT01551173|BG001|Baseline|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
11094316|NCT01551173|BG002|Baseline|Total|Total of all reporting groups
11094317|NCT01551173|FG000|Participant Flow|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
11094318|NCT01551173|FG001|Participant Flow|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
11094319|NCT01551173|OG000|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
11094320|NCT01551173|OG001|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
11094321|NCT01551173|EG000|Reported Event|LescolXL (Fluvastatin Sodium Extended Release Tablet)|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
11094322|NCT01551173|EG001|Reported Event|LescolIR (Fluvastatin Sodium Immediate Release Capsule)|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
11094323|NCT01551173|EG002|Reported Event|Total|
11094324|NCT01551186|BG000|Baseline|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis~Lactobacillus rhamnosus GG: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
11094325|NCT01551186|BG001|Baseline|Standard of Care|Patients in the control arm will receive standard care
11094326|NCT01551186|BG002|Baseline|Total|Total of all reporting groups
11094327|NCT01551186|FG000|Participant Flow|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis~Lactobacillus rhamnosus GG: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
11094328|NCT01551186|FG001|Participant Flow|Standard of Care|Patients in the control arm will receive standard care
11094329|NCT01551186|OG000|Outcome|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis~Lactobacillus rhamnosus GG: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
11094330|NCT01551186|OG001|Outcome|Standard of Care|Patients in the control arm will receive standard care
11094331|NCT01551186|EG000|Reported Event|Probiotic|"Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis~Lactobacillus rhamnosus GG: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis"
11094332|NCT01551186|EG001|Reported Event|Standard of Care|Patients in the control arm will receive standard care
11094333|NCT01551199|BG000|Baseline|Multiple Channel Exposure Therapy (MCET)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
11094334|NCT01551199|FG000|Participant Flow|Multiple Channel Exosure Therapy (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
11094335|NCT01551199|OG000|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
11094336|NCT01551199|EG000|Reported Event|Arm 1|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
11094337|NCT01551212|BG000|Baseline|Everolimus/Tacrolimus|Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
11094338|NCT01551212|BG001|Baseline|Tacrolimus|Tacrolimus (C0-h: 6-10 ng/ml)
11094339|NCT01551212|BG002|Baseline|Total|Total of all reporting groups
11094340|NCT01551212|FG000|Participant Flow|Everolimus/Tacrolimus|Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
11094341|NCT01551212|FG001|Participant Flow|Tacrolimus|Tacrolimus (C0-h: 6-10 ng/ml)
11094342|NCT01551212|OG000|Outcome|Everolimus/Tacrolimus|Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
11094343|NCT01551212|OG001|Outcome|Tacrolimus|Tacrolimus (C0-h: 6-10 ng/ml)
11094344|NCT01551212|EG000|Reported Event|Everolimus/Tacrolimus|Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
11094345|NCT01551212|EG001|Reported Event|Tacrolimus|Tacrolimus (C0-h: 6-10 ng/ml)
11094346|NCT01551264|BG000|Baseline|4-Year Bracing Arm|"This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 4 years."
11094347|NCT01551264|BG001|Baseline|2-Year Bracing Arm|"This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 2 years."
11094348|NCT01551264|BG002|Baseline|Total|Total of all reporting groups
11094349|NCT01551264|FG000|Participant Flow|4-Year Bracing Arm|"This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 4 years."
11094350|NCT01551264|FG001|Participant Flow|2-Year Bracing Arm|"This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 2 years."
11094351|NCT01551264|OG000|Outcome|4-Year Bracing Arm|"This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for either 2 or 4 years depending on which arm they are in."
11094352|NCT01551264|OG001|Outcome|2-Year Bracing Arm|"This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for either 2 or 4 years depending on which arm they are in."
11094353|NCT01551264|EG000|Reported Event|4-Year Bracing Arm|"This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 4 years."
11094354|NCT01551264|EG001|Reported Event|2-Year Bracing Arm|"This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.~Foot Abduction Brace (FAB): After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for 2 years."
11094355|NCT01551303|BG000|Baseline|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
11094356|NCT01551303|BG001|Baseline|Placebo|Placebo, 0.77 ml, intranasal
11094357|NCT01551303|BG002|Baseline|Total|Total of all reporting groups
11094358|NCT01551303|FG000|Participant Flow|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
11094359|NCT01551303|FG001|Participant Flow|Placebo|Placebo, 0.77 ml, intranasal
11094360|NCT01551303|OG000|Outcome|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
11094361|NCT01551303|OG001|Outcome|Placebo|Placebo, 0.77 ml, intranasal
11094362|NCT01551303|EG000|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
11094363|NCT01551303|EG001|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
11094364|NCT01551355|BG000|Baseline|Healthy Habits Intervention - Children|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
11094365|NCT01551355|BG001|Baseline|Usual Curriculum - Children|Control preschool facilities continued with their usual preschool curriculum
11094366|NCT01551355|BG002|Baseline|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
11094367|NCT01551355|BG003|Baseline|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
11094368|NCT01551355|BG004|Baseline|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
11094369|NCT01551355|BG005|Baseline|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
11094370|NCT01551355|BG006|Baseline|Total|Total of all reporting groups
11094371|NCT01551355|FG000|Participant Flow|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
11094372|NCT01551355|FG001|Participant Flow|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
11094373|NCT01551355|FG002|Participant Flow|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
11094374|NCT01551355|FG003|Participant Flow|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
11094375|NCT01551355|FG004|Participant Flow|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
11094376|NCT01551355|FG005|Participant Flow|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
11094377|NCT01551355|OG000|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
11094378|NCT01551355|OG001|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
11094379|NCT01551355|OG000|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
11094380|NCT01551355|OG001|Outcome|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
11094381|NCT01551355|EG000|Reported Event|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
11094382|NCT01551355|EG001|Reported Event|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
11094383|NCT01551420|BG000|Baseline|Advanced Upper Limb Prosthetic Device IMU Controlled|"Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls~Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled"
11094384|NCT01551420|BG001|Baseline|Advanced Upper Limb Prosthetic EMG-PR Controlled|"Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls~Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled"
11094385|NCT01551420|BG002|Baseline|Total|Total of all reporting groups
11094386|NCT01551420|FG000|Participant Flow|Advanced Upper Limb Prosthetic Device IMU Controlled|"Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls~Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled"
11094387|NCT01551420|FG001|Participant Flow|Advanced Upper Limb Prosthetic EMG-PR Controlled|"Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls~Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled"
11094388|NCT01551420|OG000|Outcome|Advanced Upper Limb Prosthetic Device IMU Controlled|"Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls~Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled"
11094389|NCT01551420|OG001|Outcome|Advanced Upper Limb Prosthetic EMG-PR Controlled|"Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls~Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled"
11094390|NCT01551420|EG000|Reported Event|Advanced Upper Limb Prosthetic Device IMU Controlled|"Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls~Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled"
11094391|NCT01551420|EG001|Reported Event|Advanced Upper Limb Prosthetic EMG-PR Controlled|"Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls~Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled"
11094392|NCT01551693|BG000|Baseline|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094393|NCT01551693|BG001|Baseline|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094394|NCT01551693|BG002|Baseline|Total|Total of all reporting groups
11094395|NCT01551693|FG000|Participant Flow|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094396|NCT01551693|FG001|Participant Flow|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094397|NCT01551693|OG000|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094398|NCT01551693|OG001|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094399|NCT01551693|EG000|Reported Event|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094400|NCT01551693|EG001|Reported Event|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
11094401|NCT01551745|BG000|Baseline|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
11094402|NCT01551745|FG000|Participant Flow|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
11094403|NCT01551745|OG000|Outcome|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
11094404|NCT01551745|EG000|Reported Event|Vigil™ Vaccine|"Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).~Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks."
11094405|NCT01551758|BG000|Baseline|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
11094406|NCT01551758|BG001|Baseline|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094407|NCT01551758|BG002|Baseline|Total|Total of all reporting groups
11094408|NCT01551758|FG000|Participant Flow|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
11094409|NCT01551758|FG001|Participant Flow|Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094410|NCT01551758|OG000|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
11094411|NCT01551758|OG001|Outcome|FF/VI 100 mcg/25 mcg|"Existing Maintenance Therapy:~Long acting bronchodilator therapy alone~ICS alone or in combination with a long acting bronchodilator~Triple maintenance therapy"
11094412|NCT01551758|OG001|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11217766|NCT02316366|EG000|Reported Event|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11094413|NCT01551758|OG001|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094414|NCT01551758|OG001|Outcome|FF/VI 100 mcg/25 mcg|ExParticipants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094415|NCT01551758|OG001|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094416|NCT01551758|EG000|Reported Event|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
11094417|NCT01551758|EG001|Reported Event|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
11094418|NCT01551888|BG000|Baseline|Overall Study Population|All patients participating in the crossover study
11094419|NCT01551888|FG000|Participant Flow|Sequence 1|Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
11094420|NCT01551888|FG001|Participant Flow|Sequence 2|Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
11094421|NCT01551888|OG000|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
11094422|NCT01551888|OG001|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
11094423|NCT01551888|EG000|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed dose combination (FDC) administered via Almirall inhaler
11094424|NCT01551888|EG001|Reported Event|Formoterol 12 μg|Administered via Foradil® Aerolizer®
11094425|NCT01551979|BG000|Baseline|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094426|NCT01551979|BG001|Baseline|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094427|NCT01551979|BG002|Baseline|Total|Total of all reporting groups
11094428|NCT01551979|FG000|Participant Flow|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094429|NCT01551979|FG001|Participant Flow|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094430|NCT01551979|OG000|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
10827144|NCT00107900|EG001|Reported Event|30mg QD|30mg edoxaban administered once daily (QD)
10827145|NCT00107900|EG002|Reported Event|30mg BID|30mg edoxaban administered twice daily (BID)
11094431|NCT01551979|OG001|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094432|NCT01551979|EG000|Reported Event|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11217767|NCT02316366|EG001|Reported Event|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11217768|NCT02316470|BG000|Baseline|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
11094433|NCT01551979|EG001|Reported Event|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
11094434|NCT01552057|BG000|Baseline|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11094435|NCT01552057|BG001|Baseline|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
11094436|NCT01552057|BG002|Baseline|Total|Total of all reporting groups
11094437|NCT01552057|FG000|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11094438|NCT01552057|FG001|Participant Flow|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
11094439|NCT01552057|OG000|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
11313237|NCT03196505|FG001|Participant Flow|Control|"60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11094440|NCT01552057|OG001|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
11094441|NCT01552057|EG000|Reported Event|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
11094442|NCT01552057|EG001|Reported Event|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
11094443|NCT01552213|BG000|Baseline|Treatment for Glucose Intolerance|"Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.~Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary"
11094444|NCT01552213|BG001|Baseline|Minimum Intervention Control Group|"Single visit with dietician or health educator followed by routine care per provider.~Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider."
11094445|NCT01552213|BG002|Baseline|Total|Total of all reporting groups
11094446|NCT01552213|FG000|Participant Flow|Treatment for Glucose Intolerance|"Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.~Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary"
11094447|NCT01552213|FG001|Participant Flow|Minimum Intervention Control Group|"Single visit with dietician or health educator followed by routine care per provider.~Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider."
11094448|NCT01552213|OG000|Outcome|Treatment for Glucose Intolerance|"Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.~Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary"
11094449|NCT01552213|OG001|Outcome|Minimum Intervention Control Group|"Single visit with dietician or health educator followed by routine care per provider.~Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider."
11094450|NCT01552213|EG000|Reported Event|Treatment for Glucose Intolerance|"Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.~Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary"
11094451|NCT01552213|EG001|Reported Event|Minimum Intervention Control Group|"Single visit with dietician or health educator followed by routine care per provider.~Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider."
11094452|NCT01552343|BG000|Baseline|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094453|NCT01552343|BG001|Baseline|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094454|NCT01552343|BG002|Baseline|Total|Total of all reporting groups
11094455|NCT01552343|FG000|Participant Flow|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094456|NCT01552343|FG001|Participant Flow|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094457|NCT01552343|OG000|Outcome|All Participants|All study participants
11094458|NCT01552343|OG000|Outcome|Non-Responders|Participants who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1
11094459|NCT01552343|OG001|Outcome|Responders|Participants who experienced a reduction from baseline of >=33% in nocturnal voids at the Month 1
11094460|NCT01552343|OG000|Outcome|< 3 Voids|Study participants who had <3 voids average from the screening and baseline diaries.
11094461|NCT01552343|OG001|Outcome|>= 3 Voids|Study participants who had >=3 voids average from the screening and baseline diaries.
11094462|NCT01552343|OG000|Outcome|Desmopressin|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. Male participants took 1 tablet of 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094463|NCT01552343|OG001|Outcome|Placebo|Participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094464|NCT01552343|OG000|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11313238|NCT03196505|OG000|Outcome|Liposomal Bupivacaine|"Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11094465|NCT01552343|OG001|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094466|NCT01552343|OG002|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094467|NCT01552343|OG003|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094468|NCT01552343|EG000|Reported Event|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094469|NCT01552343|EG001|Reported Event|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
11094470|NCT01552369|BG000|Baseline|Preemptive Therapy|900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. n=100
11094471|NCT01552369|BG001|Baseline|Prophylaxis|900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction. n=105
11094472|NCT01552369|BG002|Baseline|Total|Total of all reporting groups
11094473|NCT01552369|FG000|Participant Flow|Preemptive Therapy|900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. n=100
11094474|NCT01552369|FG001|Participant Flow|Prophylaxis|900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction. n=105
11094475|NCT01552369|OG000|Outcome|Preemptive Therapy|900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction.
11094476|NCT01552369|OG001|Outcome|Prophylaxis|900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction.
11094477|NCT01552369|OG000|Outcome|Preemptive Therapy|900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. n=100
11094478|NCT01552369|OG001|Outcome|Prophylaxis|900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction. n=105
11094479|NCT01552369|EG000|Reported Event|Preemptive Therapy|900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction.
11094480|NCT01552369|EG001|Reported Event|Prophylaxis|900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction.
10827146|NCT00107900|EG003|Reported Event|60mg QD|60mg edoxaban administered once daily (QD)
11094481|NCT01552408|BG000|Baseline|0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
11094482|NCT01552408|BG001|Baseline|Targeted PRP With 0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
11094483|NCT01552408|BG002|Baseline|Total|Total of all reporting groups
11094484|NCT01552408|FG000|Participant Flow|0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
11094485|NCT01552408|FG001|Participant Flow|Targeted Pan-retinal Photocoagulation With 0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a pro re nata (PRN) schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
11094486|NCT01552408|OG000|Outcome|0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
11094487|NCT01552408|OG001|Outcome|Targeted PRP With 0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
11094488|NCT01552408|OG001|Outcome|Targeted Pan-retinal Photocoagulation With 0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a pro re nata (PRN) schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
11094489|NCT01552408|EG000|Reported Event|0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
11094490|NCT01552408|EG001|Reported Event|Targeted PRP With 0.3 mg Ranibizumab|Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
11094491|NCT01552603|BG000|Baseline|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
11217769|NCT02316470|BG001|Baseline|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11094492|NCT01552603|FG000|Participant Flow|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
11094493|NCT01552603|OG000|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
11094494|NCT01552603|EG000|Reported Event|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
11094495|NCT01552681|BG000|Baseline|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
11094496|NCT01552681|BG001|Baseline|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
11094497|NCT01552681|BG002|Baseline|Total|Total of all reporting groups
11094498|NCT01552681|FG000|Participant Flow|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
11094499|NCT01552681|FG001|Participant Flow|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
11094500|NCT01552681|OG000|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
11094501|NCT01552681|OG001|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
11094502|NCT01552681|EG000|Reported Event|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
11094503|NCT01552681|EG001|Reported Event|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
11094504|NCT01552694|BG000|Baseline|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
11094505|NCT01552694|BG001|Baseline|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
11094506|NCT01552694|BG002|Baseline|Total|Total of all reporting groups
11094507|NCT01552694|FG000|Participant Flow|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
11094508|NCT01552694|FG001|Participant Flow|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
11094509|NCT01552694|OG000|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
11094510|NCT01552694|OG001|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
11094511|NCT01552694|EG000|Reported Event|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
11094512|NCT01552694|EG001|Reported Event|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
11094513|NCT01552772|BG000|Baseline|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
11094514|NCT01552772|FG000|Participant Flow|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
11094515|NCT01552772|OG000|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
11094516|NCT01552772|OG000|Outcome|Total|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
11217770|NCT02316470|BG002|Baseline|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11094517|NCT01552772|EG000|Reported Event|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
11094518|NCT01552876|BG000|Baseline|All Subjects|All subjects who were enrolled at baseline.
11094519|NCT01552876|FG000|Participant Flow|Etafilcon A/ Nelfilcon A/Filcon II 3|etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
11094520|NCT01552876|FG001|Participant Flow|Nelfilcon A/ Etafilcon A/ Filcon II 3|nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
11094521|NCT01552876|OG000|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
11094522|NCT01552876|OG001|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
11094523|NCT01552876|OG000|Outcome|Etafilcon A|Those who wore etafilcon A.
11094524|NCT01552876|OG001|Outcome|Nelfilcon A|Those who wore nelfilcon A.
11094525|NCT01552876|OG001|Outcome|Nelfilcon A.|Those who wore nelfilcon A.
11094526|NCT01552876|OG001|Outcome|Nelfilcon A|Those who wore Nelfilcon A
11094527|NCT01552876|OG002|Outcome|Filcon II 3|All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
11094528|NCT01552876|EG000|Reported Event|Etafilcon A|Those subjects who wore etafilcon A. (Phase I & II)
11094529|NCT01552876|EG001|Reported Event|Nelfilcon A|Those subjects who wore nelfilcon A. (Phase I & II)
11094530|NCT01552876|EG002|Reported Event|Filcon II 3|Those who wore Filcon II 3 during Phase II
11094531|NCT01552889|BG000|Baseline|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
11094532|NCT01552889|BG001|Baseline|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
11094533|NCT01552889|BG002|Baseline|Total|Total of all reporting groups
11094534|NCT01552889|FG000|Participant Flow|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
11094535|NCT01552889|FG001|Participant Flow|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
11094536|NCT01552889|OG000|Outcome|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
11094537|NCT01552889|OG001|Outcome|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
11094538|NCT01552889|OG000|Outcome|Usual Care|Same as above
11094539|NCT01552889|OG001|Outcome|Collaborative Care|Same as above
10827147|NCT00107900|EG004|Reported Event|60mg BID|60mg edoxaban administered twice daily (BID)
11094540|NCT01552889|EG000|Reported Event|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
11094541|NCT01552889|EG001|Reported Event|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
11094542|NCT01552902|BG000|Baseline|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
11094543|NCT01552902|BG001|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
11094544|NCT01552902|BG002|Baseline|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
11094545|NCT01552902|BG003|Baseline|Total|Total of all reporting groups
11094546|NCT01552902|FG000|Participant Flow|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
11094547|NCT01552902|FG001|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
11094548|NCT01552902|FG002|Participant Flow|Methylphenidate|Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
11094549|NCT01552902|OG000|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
11094550|NCT01552902|OG001|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
11094551|NCT01552902|OG002|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
11094552|NCT01552902|EG000|Reported Event|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
11094553|NCT01552902|EG001|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
11094554|NCT01552902|EG002|Reported Event|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
11094555|NCT01552915|BG000|Baseline|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
11094556|NCT01552915|BG001|Baseline|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
11094557|NCT01552915|BG002|Baseline|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
11094558|NCT01552915|BG003|Baseline|Total|Total of all reporting groups
11094559|NCT01552915|FG000|Participant Flow|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
11094560|NCT01552915|FG001|Participant Flow|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
11094561|NCT01552915|FG002|Participant Flow|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
11094562|NCT01552915|OG000|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
11094563|NCT01552915|OG001|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
11094564|NCT01552915|OG002|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
11094565|NCT01552915|EG000|Reported Event|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
11094566|NCT01552915|EG001|Reported Event|SPD489|Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
11094567|NCT01552915|EG002|Reported Event|OROS-MPH|Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
11094568|NCT01552928|BG000|Baseline|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
11094569|NCT01552928|BG001|Baseline|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
11094570|NCT01552928|BG002|Baseline|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
11094571|NCT01552928|BG003|Baseline|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
11094572|NCT01552928|BG004|Baseline|Total|Total of all reporting groups
11094573|NCT01552928|FG000|Participant Flow|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
11094574|NCT01552928|FG001|Participant Flow|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
11094575|NCT01552928|FG002|Participant Flow|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
11094576|NCT01552928|FG003|Participant Flow|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
11094577|NCT01552928|OG000|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
11094578|NCT01552928|OG001|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
11094579|NCT01552928|OG002|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
11094580|NCT01552928|OG000|Outcome|Anagrelide 0.5 mg (Males)|A single oral dose of 0.5 mg of anagrelide
11094581|NCT01552928|OG001|Outcome|Anagrelide 0.5 mg (Females)|A single oral dose of 0.5 mg of anagrelide
11094582|NCT01552928|OG000|Outcome|Anagrelide 2.5mg (Males)|A single oral dose of 2.5 mg of anagrelide
11094583|NCT01552928|OG001|Outcome|Anagrelide 2.5mg (Females)|A single oral dose of 2.5 mg of anagrelide
11094584|NCT01552928|OG000|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 0.5 mg of anagrelide
11094585|NCT01552928|OG001|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 0.5 mg of anagrelide
11094586|NCT01552928|OG000|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 2.5 mg of anagrelide
11094587|NCT01552928|OG001|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 2.5 mg of anagrelide
11094588|NCT01552928|EG000|Reported Event|Anagrelide 0.5mg|
11094589|NCT01552928|EG001|Reported Event|Anagrelide 2.5mg|
11094590|NCT01552928|EG002|Reported Event|Moxifloxacin 400mg|
11094591|NCT01552928|EG003|Reported Event|Placebo|
11094592|NCT01552954|BG000|Baseline|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
11094593|NCT01552954|BG001|Baseline|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
11094594|NCT01552954|BG002|Baseline|Total|Total of all reporting groups
11094595|NCT01552954|FG000|Participant Flow|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
10827148|NCT00107900|EG005|Reported Event|120mg QD|120mg edoxaban administered once daily (QD)
11094596|NCT01552954|FG001|Participant Flow|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
11094597|NCT01552954|OG000|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
11094598|NCT01552954|OG001|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
11094599|NCT01552954|EG000|Reported Event|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
11094600|NCT01552954|EG001|Reported Event|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
11094601|NCT01553058|BG000|Baseline|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
11094602|NCT01553058|BG001|Baseline|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
11094603|NCT01553058|BG002|Baseline|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
11094604|NCT01553058|BG003|Baseline|Total|Total of all reporting groups
11094605|NCT01553058|FG000|Participant Flow|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
11094606|NCT01553058|FG001|Participant Flow|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
11094607|NCT01553058|FG002|Participant Flow|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
11094608|NCT01553058|OG000|Outcome|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
11094609|NCT01553058|OG001|Outcome|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
11094610|NCT01553058|OG002|Outcome|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
11094611|NCT01553058|OG000|Outcome|Adalimumab (Humira)|Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
11094612|NCT01553058|OG001|Outcome|Placebo Injection|Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
11094613|NCT01553058|OG002|Outcome|NB-UVB Phototherapy|NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
11094614|NCT01553058|OG001|Outcome|Placebo Injection|njection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
11094615|NCT01553058|EG000|Reported Event|Adalimumab (Humira)|"Injection of the active drug Humira.~Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule."
11094616|NCT01553058|EG001|Reported Event|Placebo Injection|"Injection of placebo in place of active Humira injection.~Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator."
11094617|NCT01553058|EG002|Reported Event|NB-UVB Phototherapy|"NB-UVB Phototherapy 3 times per week, no other intervention.~NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types."
11094618|NCT01553084|BG000|Baseline|Effectiveness of Nicotine Patch Only|Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
11094619|NCT01553084|BG001|Baseline|Effectiveness of Combination NRT|"Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.~Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects."
11094620|NCT01553084|BG002|Baseline|Effectiveness of Varenicline [Chantix]|Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
11094621|NCT01553084|BG003|Baseline|Total|Total of all reporting groups
11094622|NCT01553084|FG000|Participant Flow|Effectiveness of Nicotine Patch Only|Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
11094623|NCT01553084|FG001|Participant Flow|Effectiveness of Combination NRT|"Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.~Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects."
11094624|NCT01553084|FG002|Participant Flow|Effectiveness of Varenicline [Chantix]|Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
11094625|NCT01553084|OG000|Outcome|Effectiveness of Nicotine Patch Only|Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
11217771|NCT02316470|BG003|Baseline|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
11217772|NCT02316470|BG004|Baseline|Total|Total of all reporting groups
10827149|NCT00107952|BG000|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
11094626|NCT01553084|OG001|Outcome|Effectiveness of Combination NRT|"Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.~Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects."
11094627|NCT01553084|OG002|Outcome|Effectiveness of Varenicline [Chantix]|Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
11094628|NCT01553084|OG000|Outcome|Abstinent at Year 3|Participants who are abstinent at Year 3 with biochemical confirmation.
11094629|NCT01553084|OG001|Outcome|Smoking at Year 3|Participants who are smoking at Year 3.
11094630|NCT01553084|EG000|Reported Event|Effectiveness of Nicotine Patch Only|Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
11094631|NCT01553084|EG001|Reported Event|Effectiveness of Combination NRT|"Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.~Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects."
11094632|NCT01553084|EG002|Reported Event|Effectiveness of Varenicline [Chantix]|Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
11094633|NCT01553136|BG000|Baseline|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094634|NCT01553136|BG001|Baseline|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094635|NCT01553136|BG002|Baseline|Total|Total of all reporting groups
11094636|NCT01553136|FG000|Participant Flow|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094637|NCT01553136|FG001|Participant Flow|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094638|NCT01553136|OG000|Outcome|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094639|NCT01553136|OG001|Outcome|Placebo|Placebo: once per day for Days 1 to 3, twice per day for the remaining days
11094640|NCT01553136|EG000|Reported Event|Varenicline|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094641|NCT01553136|EG001|Reported Event|Sugar Pill|Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
11094642|NCT01553188|BG000|Baseline|DL 1 Run in - 15mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094643|NCT01553188|BG001|Baseline|DL 2 Run in - 30mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094644|NCT01553188|BG002|Baseline|Abiraterone, Prednisone and AMG|"Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094645|NCT01553188|BG003|Baseline|Abiraterone and Prednisone Only|"Abiraterone and prednisone only~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094646|NCT01553188|BG004|Baseline|Total|Total of all reporting groups
11094647|NCT01553188|FG000|Participant Flow|DL 1 Run in - 15mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094648|NCT01553188|FG001|Participant Flow|DL 2 Run in - 30mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094649|NCT01553188|FG002|Participant Flow|Abiraterone, Prednisone and AMG|"Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094650|NCT01553188|FG003|Participant Flow|Abiraterone and Prednisone Only|"Abiraterone and prednisone only~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094651|NCT01553188|OG000|Outcome|DL 1 Run in - 15mg/kg|"Dose escalation phase to determine MTD of AMG AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg The randomized portion is 30 mg/kg."
11094652|NCT01553188|OG001|Outcome|DL 2 Run in - 30mg/kg|"Dose escalation phase to determine MTD of AMG AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg The randomized portion is 30 mg/kg."
11094653|NCT01553188|OG002|Outcome|Abiraterone, Prednisone and AMG|"Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094654|NCT01553188|OG003|Outcome|Abiraterone and Prednisone Only|"Abiraterone and prednisone only~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094655|NCT01553188|OG000|Outcome|DL 1 Run in - 15mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094656|NCT01553188|OG001|Outcome|DL 2 Run in - 30mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094657|NCT01553188|OG000|Outcome|All Participants|All participants who had at least one dose of Abiraterone, prednisone, and/or Trebananib (AMG 386).
11094658|NCT01553188|EG000|Reported Event|DL 1 Run in - 15mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094659|NCT01553188|EG001|Reported Event|DL 2 Run in - 30mg/kg|"Dose escalation phase to determine MTD of AMG~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg).~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~DL 1 AMG is 15 mg/kg DL 2 AMG is 30 mg/kg~The randomized portion is 30 mg/kg."
11094660|NCT01553188|EG002|Reported Event|Abiraterone, Prednisone and AMG|"Abiraterone and prednisone will be given with maximum tolerated dose (MTD) of Trebananib (AMG)~AMG 386: AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094661|NCT01553188|EG003|Reported Event|Abiraterone and Prednisone Only|"Abiraterone and prednisone only~Abiraterone: A 1,000 mg dose of abiraterone should be taken orally once daily~Prednisone: Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference."
11094662|NCT01553201|BG000|Baseline|Botulinum Toxin (BoNT)|OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
11094663|NCT01553201|BG001|Baseline|Placebo|Saline, 4cc, one time intramuscular administration
11094664|NCT01553201|BG002|Baseline|Total|Total of all reporting groups
11094665|NCT01553201|FG000|Participant Flow|Botulinum Toxin (BoNT)|OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
11094666|NCT01553201|FG001|Participant Flow|Placebo|Saline, 4cc, one time intramuscular administration
11094667|NCT01553201|OG000|Outcome|Botulinum Toxin (BoNT)|OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
11094668|NCT01553201|OG001|Outcome|Placebo|Saline, 4cc, one time intramuscular administration
11094669|NCT01553201|EG000|Reported Event|Botulinum Toxin (BoNT)|OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
11094670|NCT01553201|EG001|Reported Event|Placebo|Saline, 4cc, one time intramuscular administration
11094671|NCT01553279|BG000|Baseline|V419 and MCC-TT|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094672|NCT01553279|BG001|Baseline|V419 and MCC-CRM|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094673|NCT01553279|BG002|Baseline|Total|Total of all reporting groups
11094674|NCT01553279|FG000|Participant Flow|V419 and MCC-TT|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094675|NCT01553279|FG001|Participant Flow|V419 and MCC-CRM|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094676|NCT01553279|OG000|Outcome|V419 and MCC-TT|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094677|NCT01553279|OG001|Outcome|V419 and MCC-CRM|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094678|NCT01553279|OG000|Outcome|V419 + MCC-TT/MCC-CRM|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT or MCC-CRM (at 3 and 4 months of age).
11094679|NCT01553279|EG000|Reported Event|V419 and MCC-TT|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094680|NCT01553279|EG001|Reported Event|V419 and MCC-CRM|In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
11094681|NCT01553292|BG000|Baseline|Angiocath Surfactant|Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
11094682|NCT01553292|FG000|Participant Flow|Surfactant Through Vascular Catheter|Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
11094683|NCT01553292|OG000|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
11094684|NCT01553292|OG000|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
11094685|NCT01553292|OG000|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
11094686|NCT01553292|EG000|Reported Event|Angiocath Surfactant|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
11094687|NCT01553318|BG000|Baseline|Ketotifen Group|Participants who received the active drug - ketotifen
11094688|NCT01553318|BG001|Baseline|Placebo|Participants who received the placebo
11094689|NCT01553318|BG002|Baseline|Total|Total of all reporting groups
11094690|NCT01553318|FG000|Participant Flow|Ketotifen|ketotifen active group
11094691|NCT01553318|FG001|Participant Flow|Placebo|Placebo medication
11094692|NCT01553318|OG000|Outcome|Ketotifen|Ketotifen active drug
11094693|NCT01553318|OG001|Outcome|Placebo|received placebo
11094694|NCT01553318|OG000|Outcome|Ketotifen|active drug group
11094695|NCT01553318|OG001|Outcome|Placebo|placebo group
11094696|NCT01553318|EG000|Reported Event|Ketotifen|Received ketotifen the active drug
11094697|NCT01553318|EG001|Reported Event|Placebo|received placebo
11094698|NCT01553539|BG000|Baseline|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
11094699|NCT01553539|FG000|Participant Flow|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.
11094700|NCT01553539|OG000|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
11094701|NCT01553539|EG000|Reported Event|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
11094702|NCT01553591|BG000|Baseline|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
11094703|NCT01553591|BG001|Baseline|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
11094704|NCT01553591|BG002|Baseline|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
11094705|NCT01553591|BG003|Baseline|Total|Total of all reporting groups
11094706|NCT01553591|FG000|Participant Flow|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
11094707|NCT01553591|FG001|Participant Flow|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
11094708|NCT01553591|FG002|Participant Flow|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
11094709|NCT01553591|OG000|Outcome|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
11094710|NCT01553591|OG001|Outcome|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
11094711|NCT01553591|OG002|Outcome|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
11094712|NCT01553591|EG000|Reported Event|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
11094713|NCT01553591|EG001|Reported Event|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
11094714|NCT01553591|EG002|Reported Event|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
11094715|NCT01553708|BG000|Baseline|Epidermal Growth Factor With Silver Sulfadiazine Cream|
11094716|NCT01553708|BG001|Baseline|Silver Zinc Sulfadiazine Cream|
11094717|NCT01553708|BG002|Baseline|Total|Total of all reporting groups
11094718|NCT01553708|FG000|Participant Flow|Epidermal Growth Factor With Silver Sulfadiazine Cream|
11094719|NCT01553708|FG001|Participant Flow|Silver Zinc Sulfadiazine Cream|
11094720|NCT01553708|OG000|Outcome|Epidermal Growth Factor With Silver Sulfadiazine Cream|Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
11094721|NCT01553708|OG001|Outcome|Silver Zinc Sulfadiazine Cream|Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
11094722|NCT01553708|EG000|Reported Event|Epidermal Growth Factor With Silver Sulfadiazine Cream|
11094723|NCT01553708|EG001|Reported Event|Silver Zinc Sulfadiazine Cream|
11094724|NCT01553747|BG000|Baseline|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094725|NCT01553747|BG001|Baseline|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094726|NCT01553747|BG002|Baseline|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11313239|NCT03196505|OG001|Outcome|Control|"60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11094727|NCT01553747|BG003|Baseline|Total|Total of all reporting groups
11094728|NCT01553747|FG000|Participant Flow|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094729|NCT01553747|FG001|Participant Flow|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094730|NCT01553747|FG002|Participant Flow|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094731|NCT01553747|OG000|Outcome|Eluxadoline 75 mg|Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094732|NCT01553747|OG001|Outcome|Eluxadoline 100 mg|Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094733|NCT01553747|OG002|Outcome|Placebo|Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
11094734|NCT01553747|EG000|Reported Event|Eluxadoline 75 mg (Treatment Period)|Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
11094735|NCT01553747|EG001|Reported Event|Eluxadoline 100 mg (Treatment Period)|Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
11094736|NCT01553747|EG002|Reported Event|Placebo (Treatment Period)|Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
11094737|NCT01553747|EG003|Reported Event|Eluxadoline 75 mg (Blinded-Placebo Period)|Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
11094738|NCT01553747|EG004|Reported Event|Eluxadoline 100 mg (Blinded-Placebo Period)|Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.
11094739|NCT01553747|EG005|Reported Event|Placebo (Blinded-Placebo Period)|Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks.
11094740|NCT01553851|BG000|Baseline|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
11094741|NCT01553851|FG000|Participant Flow|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
11094742|NCT01553851|OG000|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
11094743|NCT01553851|EG000|Reported Event|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
11094744|NCT01553916|BG000|Baseline|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
11094745|NCT01553916|FG000|Participant Flow|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
11094746|NCT01553916|OG000|Outcome|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
11094747|NCT01553916|EG000|Reported Event|Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation|"Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.~PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium."
11094748|NCT01554176|BG000|Baseline|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
11094749|NCT01554176|BG001|Baseline|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
11094750|NCT01554176|BG002|Baseline|Total|Total of all reporting groups
11094751|NCT01554176|FG000|Participant Flow|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
11094752|NCT01554176|FG001|Participant Flow|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
11094753|NCT01554176|FG002|Participant Flow|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094754|NCT01554176|FG003|Participant Flow|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094755|NCT01554176|FG004|Participant Flow|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
11094756|NCT01554176|OG000|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
11094757|NCT01554176|OG001|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
11094758|NCT01554176|OG000|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094759|NCT01554176|OG001|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094760|NCT01554176|OG002|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
11094761|NCT01554176|EG000|Reported Event|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
11094762|NCT01554176|EG001|Reported Event|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
11094763|NCT01554176|EG002|Reported Event|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094764|NCT01554176|EG003|Reported Event|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
11094765|NCT01554176|EG004|Reported Event|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
11094766|NCT01554241|BG000|Baseline|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
11094767|NCT01554241|BG001|Baseline|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
11094768|NCT01554241|BG002|Baseline|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
11094769|NCT01554241|BG003|Baseline|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
11094770|NCT01554241|BG004|Baseline|Total|Total of all reporting groups
11094771|NCT01554241|FG000|Participant Flow|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
11094772|NCT01554241|FG001|Participant Flow|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
11094773|NCT01554241|FG002|Participant Flow|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
11094774|NCT01554241|FG003|Participant Flow|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
11094775|NCT01554241|OG000|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
11094776|NCT01554241|OG001|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
11094777|NCT01554241|OG002|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
11094778|NCT01554241|OG003|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
11094779|NCT01554241|EG000|Reported Event|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
11094780|NCT01554241|EG001|Reported Event|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
11094781|NCT01554241|EG002|Reported Event|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
11094782|NCT01554241|EG003|Reported Event|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
11094783|NCT01554371|BG000|Baseline|Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle. The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094784|NCT01554371|BG001|Baseline|Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle. The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094785|NCT01554371|BG002|Baseline|Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)|"Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094786|NCT01554371|BG003|Baseline|Total|Total of all reporting groups
11094787|NCT01554371|FG000|Participant Flow|Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094788|NCT01554371|FG001|Participant Flow|Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094789|NCT01554371|FG002|Participant Flow|Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)|"Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094790|NCT01554371|OG000|Outcome|Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094791|NCT01554371|OG000|Outcome|Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)|"Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094792|NCT01554371|OG000|Outcome|Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094793|NCT01554371|OG001|Outcome|Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094794|NCT01554371|OG002|Outcome|Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)|"Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094795|NCT01554371|OG001|Outcome|Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094796|NCT01554371|EG000|Reported Event|Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094797|NCT01554371|EG001|Reported Event|Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)|"Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094798|NCT01554371|EG002|Reported Event|Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)|"Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.~Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV"
11094799|NCT01554488|BG000|Baseline|High Dose Inhaled Fluticasone|"High dose inhaled fluticasone (1760mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094800|NCT01554488|BG001|Baseline|Low Dose Inhaled Fluticasone|"Low dose inhaled fluticasone (88mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094801|NCT01554488|BG002|Baseline|Total|Total of all reporting groups
11094802|NCT01554488|FG000|Participant Flow|High Dose Inhaled Fluticasone|High dose inhaled fluticasone (1,760mcg/day)
11094803|NCT01554488|FG001|Participant Flow|Low Dose Inhaled Fluticasone|"Low dose inhaled fluticasone (88mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094804|NCT01554488|OG000|Outcome|High Dose Inhaled Fluticasone|"High dose inhaled fluticasone (1760mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094805|NCT01554488|OG001|Outcome|Low Dose Inhaled Fluticasone|"Low dose inhaled fluticasone (88mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094806|NCT01554488|EG000|Reported Event|High Dose Inhaled Fluticasone|"High dose inhaled fluticasone (1760mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
11094807|NCT01554488|EG001|Reported Event|Low Dose Inhaled Fluticasone|"Low dose inhaled fluticasone (88mcg/day)~Inhaled Fluticasone Propionate: Inhaled corticosteroid"
10827150|NCT00107952|BG001|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
11094808|NCT01554514|BG000|Baseline|Low Dose Rituximab|"this is a single-arm trial~rituximab: rituximab intravenously 100 mg every week for four doses"
11094809|NCT01554514|FG000|Participant Flow|Low Dose Rituximab|"this is a single-arm trial~rituximab: rituximab intravenously 100 mg every week for four doses"
11094810|NCT01554514|OG000|Outcome|Low Dose Rituximab|"this is a single-arm trial~rituximab: rituximab intravenously 100 mg every week for four doses"
10827151|NCT00107952|BG002|Baseline|Total|Total of all reporting groups
11094811|NCT01554514|EG000|Reported Event|Low Dose Rituximab|"this is a single-arm trial~rituximab: rituximab intravenously 100 mg every week for four doses"
11094812|NCT01554527|BG000|Baseline|Control Group (Surgery Only - no CPAP)|The participants who were not assigned to CPAP
11094813|NCT01554527|BG001|Baseline|CPAP After Surgery (Adherent)|Those participants assigned to CPAP who had at least 4 hours of electronically recorded CPAP use per night
10827152|NCT00107952|FG000|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
10827153|NCT00107952|FG001|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
10827154|NCT00107952|OG000|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
10827155|NCT00107952|OG001|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
10827156|NCT00107952|EG000|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
11094814|NCT01554527|BG002|Baseline|CPAP After Surgery (Non-adherent)|Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night.
11094815|NCT01554527|BG003|Baseline|Total|Total of all reporting groups
11094816|NCT01554527|FG000|Participant Flow|Control Group (Surgery Only - no CPAP)|The participants who were not assigned to CPAP
11094817|NCT01554527|FG001|Participant Flow|CPAP After Surgery (Adherent)|Those participants assigned to CPAP who had at least 4 hours of electronically recorded CPAP use per night
11094818|NCT01554527|FG002|Participant Flow|CPAP After Surgery (Non-adherent)|Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night.
11094819|NCT01554527|OG000|Outcome|Control Group (Surgery Only - no CPAP)|The participants who were not assigned to CPAP
11094820|NCT01554527|OG001|Outcome|CPAP After Surgery (Non-adherent)|Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
11094821|NCT01554527|OG002|Outcome|CPAP After Surgery (Adherent)|Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
11094822|NCT01554527|OG000|Outcome|CPAP Group|Participants who were assigned to CPAP use.
11094823|NCT01554527|EG000|Reported Event|CPAP Treatment Group on CPAP|Children randomized to this arm were assigned and began up to 6 months of CPAP treatment, beginning at approximately 4 months after AT, in addition to standard of care. This arm shows AEs that happened to participants randomized to CPAP but who didn't cross over to the No CPAP group prior to sleep lab. (n=69; original n=71 minus n=2 who crossed over to no-CPAP group). Since both adherent and non-adherent CPAP participants received CPAP and had at minimum one night of CPAP exposure, these two groups were combined for the purposes of AE reporting in order to determine whether any CPAP exposure vs control group (no CPAP) had a different proportion of AE's.
11094824|NCT01554527|EG001|Reported Event|No CPAP Treatment Group|Children shown in this comparison arm were randomized to NO CPAP or were crossed over to No CPAP prior to any CPAP use or CPAP trial in sleep lab.) (N = 36, original 34 plus two crossed over from those randomized to CPAP)
11094825|NCT01554527|EG002|Reported Event|Non-randomized Participants|Participants who were consented but withdrew prior to randomization (n = 15)
11094826|NCT01554579|BG000|Baseline|Sugar Pill|Sugar Pill: Placebo
11094827|NCT01554579|BG001|Baseline|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
11094828|NCT01554579|BG002|Baseline|Total|Total of all reporting groups
11094829|NCT01554579|FG000|Participant Flow|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
11094830|NCT01554579|FG001|Participant Flow|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
11094831|NCT01554579|OG000|Outcome|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
11094832|NCT01554579|OG001|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
11094833|NCT01554579|OG000|Outcome|Sugar Pill|Sugar Pill: Placebo
11094834|NCT01554579|EG000|Reported Event|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
11094835|NCT01554579|EG001|Reported Event|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
11094836|NCT01554618|BG000|Baseline|Exenatide|"Controlled assessment period: Patients received exenatide 2 mg SC injection once weekly for 24 weeks.~Extension period: Patients continued to receive exenatide 2 mg SC once weekly during the open-label extension period for 28 weeks (through Week 52)."
11094837|NCT01554618|BG001|Baseline|Placebo|"Controlled assessment period: Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks.~Extension period: Patients then received exenatide 2 mg SC once weekly beginning at the start of the open-label extension period for 28 weeks (from Week 25 to Week 52)."
11094838|NCT01554618|BG002|Baseline|Total|Total of all reporting groups
11094839|NCT01554618|FG000|Participant Flow|Exenatide|"Controlled assessment Period: Patients received exenatide 2 milligrams (mg) subcutaneous (SC) injection once weekly for 24 weeks.~Extension period: Patients continued to receive exenatide 2 mg SC once weekly during the open-label extension period for 28 weeks (through Week 52)."
11094840|NCT01554618|FG001|Participant Flow|Placebo|"Controlled assessment period: Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks.~Extension period: Patients then received exenatide 2 mg SC once weekly beginning at the start of the open-label extension period for 28 weeks (from Week 25 to Week 52)."
11094841|NCT01554618|OG000|Outcome|Controlled Assessment Period - Exenatide|Patients received exenatide 2 mg SC injection once weekly for 24 weeks during the controlled assessment period.
11094842|NCT01554618|OG001|Outcome|Controlled Assessment Period - Placebo|Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks during the controlled assessment period.
11094843|NCT01554618|OG000|Outcome|Treatment Period - Exenatide|Patients received exenatide 2 mg SC injection once weekly for 24 weeks during the controlled assessment period and continued to receive exenatide 2 mg SC once weekly during the open-label extension period for a further 28 weeks (from Week 0 to Week 52 overall).
11094844|NCT01554618|OG001|Outcome|Treatment Period - Placebo Then Exenatide|Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks during the controlled assessment period and then received exenatide 2 mg SC once weekly beginning at the start of the open-label extension period for 28 weeks (from Week 25 to Week 52).
11094845|NCT01554618|EG000|Reported Event|Controlled Assessment Period - Exenatide|Patients received exenatide 2 mg SC injection once weekly for 24 weeks during the controlled assessment period.
11094846|NCT01554618|EG001|Reported Event|Controlled Assessment Period - Placebo|Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks during the controlled assessment period.
11094847|NCT01554618|EG002|Reported Event|Extension Period - Exenatide|Patients received open-label exenatide 2 mg SC injection once weekly for 28 weeks during the extension period. Patients in this treatment group had previously received exenatide during the controlled assessment period.
11094848|NCT01554618|EG003|Reported Event|Extension Period - Placebo to Exenatide|Patients received open-label exenatide 2 mg SC injection once weekly for 28 weeks during the extension period. Patients in this treatment group had previously received placebo during the controlled assessment period.
11094849|NCT01554683|BG000|Baseline|All Study Participants|Saline administration via IV infusion over 20 min, High dose LEV 7.5mg/kg, and Low dose LEV at 2.5mg/kg in random order
11094850|NCT01554683|FG000|Participant Flow|High Dose Levetiracetam, Low Dose, Placebo|levetiracetam given at a dose of 7.5mg/kg over 20 minutes followed by LEV at a dose of 2.5mg/kg over 20 minutes followed by Placebo over 20 minutes
11094851|NCT01554683|FG001|Participant Flow|Low Dose Levetiracetam, High Dose, Placebo|Levetiracetam given at a dose of 2.5mg/kg over 20 minutes followed by LEV at 7.5mg/kg over 20 minutes followed by Placebo
11094852|NCT01554683|FG002|Participant Flow|Placebo Administration, High Dose LEV, Low Dose|Saline administration via IV infusion over 20 min followed by LEV at 7.5mg/kg followed by LEV at 2.5 mg/kg
11094853|NCT01554683|FG003|Participant Flow|High Dose LEV, Placebo, Low Dose|LEV at 7.5mg/kg followed by Placebo, followed by LEV at 2.5mg/kg
11094854|NCT01554683|FG004|Participant Flow|Low Dose LEV, Placebo, High Dose LEV|Low dose LEV at 2.5mg/kg followed by placebo followed by High Dose LEV at 7.5mg/kg
11094855|NCT01554683|FG005|Participant Flow|Placebo, Low Dose LEV, High Dose LEV|Placebo, followed by low dose LEV at 2.5mg/kg followed by High dose LEV at 7.5mg/kg
11094856|NCT01554683|OG000|Outcome|High Dose Levetiracetam|levetiracetam given at a dose of 7.5mg/kg over 20 minutes
11094857|NCT01554683|OG001|Outcome|Low Dose Levetiracetam|Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
11094858|NCT01554683|OG002|Outcome|Placebo Administration|Saline administration via IV infusion over 20 min
11094859|NCT01554683|EG000|Reported Event|High Dose Levetiracetam|levetiracetam given at a dose of 7.5mg/kg over 20 minutes
11094860|NCT01554683|EG001|Reported Event|Low Dose Levetiracetam|Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
11094861|NCT01554683|EG002|Reported Event|Placebo Administration|Saline administration via IV infusion over 20 min
11094862|NCT01554891|BG000|Baseline|Test-Retest Reliability of SAFE-TBI|100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
11094863|NCT01554891|BG001|Baseline|Comparison of SAFE-TBI and VA Screen|100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
11313240|NCT03196505|EG000|Reported Event|Liposomal Bupivacaine|"Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11313241|NCT03196505|EG001|Reported Event|Control|"60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).~Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites)."
11313242|NCT03196635|BG000|Baseline|All Study Participants|"All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC/MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.~Patient-Assisted Breast Compression: The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC/MLO."
11313243|NCT03196635|FG000|Participant Flow|All Study Participants|All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocuadal [CC] and mediolateral oblique [MLO]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.
11313244|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
11313245|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
11313246|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|Repeat imaging for PA compression image sets were indicated for each subject by technologists during image acquisitions and by readers during image evaluations.
11313247|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|Repeat imaging for TC compression image sets were indicated for each subject by technologists during image acquisitions and by readers during image evaluations.
11313248|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|All image sets (30 PA compression image sets) were evaluated for acceptability of specific mammographic attributes by two (2) readers. Both readers evaluated all image sets from all available subjects.
11313249|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|All image sets (30 TC compression image sets) were evaluated for acceptability of specific mammographic attributes by two (2) readers. Both readers evaluated all image sets from all available subjects.
11313250|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|Total image acquisition time was collected for each image set
11313251|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|Total image acquisition time was collected for each image set.
11313252|NCT03196635|OG000|Outcome|All Study Participants|Technologists were asked to document if any intervention on compression was required during the PA compression procedures. If so, clarification regarding what type of intervention was performed was requested.
11313253|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|Compression force (daN) was captured for each view under Patient-Assisted Compression.
11313254|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|Compression force (daN) was captured for each view under Technologist Compression.
11313255|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|Breast Thickness (mm) was captured for each view under PA Compression.
11313256|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|Breast Thickness (mm) was captured for each view under TC compression.
11313257|NCT03196635|OG000|Outcome|All Study Participants, PA Compression Image Sets|ESAK (mGy) was captured for each view under PA Compression.
11313258|NCT03196635|OG001|Outcome|All Study Participants, TC Compression Image Sets|ESAK (mGy) was captured for each view under TC compression.
11313259|NCT03196635|EG000|Reported Event|All Study Participants|Except for one subject who withdrew from the study prior to imaging procedures, all subjects underwent their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC and MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set was obtained, utilizing the patient-assisted breast compression mode.
10827157|NCT00107952|EG001|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
11313260|NCT03196791|BG000|Baseline|Deep Neuromuscular Block Group|"Sugammadex sodium 4mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313261|NCT03196791|BG001|Baseline|Moderate Neuromuscular Group|"Sugammadex sodium 2mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313262|NCT03196791|BG002|Baseline|Total|Total of all reporting groups
11313263|NCT03196791|FG000|Participant Flow|Deep Neuromuscular Block Group|"Sugammadex sodium 4mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313264|NCT03196791|FG001|Participant Flow|Moderate Neuromuscular Group|"Sugammadex sodium 2mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313265|NCT03196791|OG000|Outcome|Deep Neuromuscular Block Group|"Sugammadex sodium 4mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313266|NCT03196791|OG001|Outcome|Moderate Neuromuscular Group|"Sugammadex sodium 2mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313267|NCT03196791|EG000|Reported Event|Deep Neuromuscular Block Group|"Sugammadex sodium 4mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313268|NCT03196791|EG001|Reported Event|Moderate Neuromuscular Group|"Sugammadex sodium 2mg/kg/IV after operation~Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.~2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
11313269|NCT03196973|BG000|Baseline|DF289 Plus DF277|"Otic solution~DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days"
11313270|NCT03196973|BG001|Baseline|DF289|"Otic solution~DF289: 1 vial into the affected ear twice daily for 7 days"
11313271|NCT03196973|BG002|Baseline|DF277|"Otic solution~DF277: 1 vial into the affected ear twice daily for 7 days"
11313272|NCT03196973|BG003|Baseline|Total|Total of all reporting groups
11313273|NCT03196973|FG000|Participant Flow|DF289 Plus DF277|"Otic solution~DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days"
11313274|NCT03196973|FG001|Participant Flow|DF289|"Otic solution~DF289: 1 vial into the affected ear twice daily for 7 days"
10827158|NCT00107978|BG000|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
10827159|NCT00107978|BG001|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
11313275|NCT03196973|FG002|Participant Flow|DF277|"Otic solution~DF277: 1 vial into the affected ear twice daily for 7 days"
11313276|NCT03196973|OG000|Outcome|DF289 Plus DF277|"Otic solution~DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days"
11313277|NCT03196973|OG001|Outcome|DF289|"Otic solution~DF289: 1 vial into the affected ear twice daily for 7 days"
11313278|NCT03196973|OG002|Outcome|DF277|"Otic solution~DF277: 1 vial into the affected ear twice daily for 7 days"
11313279|NCT03196973|EG000|Reported Event|DF289 Plus DF277|"Otic solution~DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days"
11313280|NCT03196973|EG001|Reported Event|DF289|"Otic solution~DF289: 1 vial into the affected ear twice daily for 7 days"
11313281|NCT03196973|EG002|Reported Event|DF277|"Otic solution~DF277: 1 vial into the affected ear twice daily for 7 days"
11313282|NCT03197025|BG000|Baseline|Dose Level -1: 0.7 x 10^10 Transduced T Cells|"Patients will undergo leukapheresis, then treatment with E6 T Cell Receptor (TCR) cells (at escalating doses) + aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg (based on total body weight) intravenous (IV) infused over 15 minutes approximately every 12 hours for a maximum of two doses.~E6 T Cell Receptor (TCR): On day 0, the E6 TCR cells will be administered one time, intravenously over 20 to 30 minutes"
11313283|NCT03197025|FG000|Participant Flow|Dose Level -1: 0.7 x 10^10 Transduced T Cells|"Patients will undergo leukapheresis, then treatment with E6 T Cell Receptor (TCR) cells (at escalating doses) + aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg (based on total body weight) intravenous (IV) infused over 15 minutes approximately every 12 hours for a maximum of two doses.~E6 T Cell Receptor (TCR): On day 0, the E6 TCR cells will be administered one time, intravenously over 20 to 30 minutes"
11313284|NCT03197025|OG000|Outcome|Dose Level -1: 0.7 x 10^10 Transduced T Cells|"Patients will undergo leukapheresis, then treatment with E6 T Cell Receptor (TCR) cells (at escalating doses) + aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg (based on total body weight) intravenous (IV) infused over 15 minutes approximately every 12 hours for a maximum of two doses.~E6 T Cell Receptor (TCR): On day 0, the E6 TCR cells will be administered one time, intravenously over 20 to 30 minutes"
11313285|NCT03197025|EG000|Reported Event|Dose Level -1: 0.7 x 10^10 Transduced T Cells|"Patients will undergo leukapheresis, then treatment with E6 T Cell Receptor (TCR) cells (at escalating doses) + aldesleukin~Aldesleukin: Aldesleukin 720,000 IU/kg (based on total body weight) intravenous (IV) infused over 15 minutes approximately every 12 hours for a maximum of two doses.~E6 T Cell Receptor (TCR): On day 0, the E6 TCR cells will be administered one time, intravenously over 20 to 30 minutes"
11313286|NCT03197038|BG000|Baseline|Home-based Walking Exercise|"Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.~Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise."
11313287|NCT03197038|BG001|Baseline|Control|"The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.~Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly."
11313288|NCT03197038|BG002|Baseline|Total|Total of all reporting groups
11313289|NCT03197038|FG000|Participant Flow|Home-based Walking Exercise|"Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.~Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise."
11313290|NCT03197038|FG001|Participant Flow|Control|"The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.~Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly."
11313291|NCT03197038|OG000|Outcome|Home-based Walking Exercise|"Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.~Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise."
11335884|NCT03558230|BG001|Baseline|No Vibration|"The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Placebo (for vibration): No vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
10827160|NCT00107978|BG002|Baseline|Total|Total of all reporting groups
10827161|NCT00107978|FG000|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
11313292|NCT03197038|OG001|Outcome|Control|"The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.~Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly."
11313293|NCT03197038|EG000|Reported Event|Home-based Walking Exercise|"Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.~Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise."
11313294|NCT03197038|EG001|Reported Event|Control|"The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.~Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly."
11313295|NCT03197129|BG000|Baseline|SADE Waiting Room|"children that will wait in the SADE waiting room~sensory adapted waiting room: The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers."
11313296|NCT03197129|BG001|Baseline|Traditional Waiting Room|children that will wait in the traditional waiting room
11313297|NCT03197129|BG002|Baseline|Total|Total of all reporting groups
11313298|NCT03197129|FG000|Participant Flow|SADE Waiting Room|"children that will wait in the SADE waiting room~sensory adapted waiting room: The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers."
11313299|NCT03197129|FG001|Participant Flow|Traditional Waiting Room|"children that will wait in the traditional waiting room~This waiting room consisted of ten seats in one row facing the reception desk, and was air-conditioned, well-lit, without posters or paintings on the walls, and no reading material."
11313300|NCT03197129|OG000|Outcome|SADE Waiting Room|"children that will wait in the SADE waiting room~sensory adapted waiting room: The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers."
11313301|NCT03197129|OG001|Outcome|Traditional Waiting Room|children that will wait in the traditional waiting room
11313302|NCT03197129|EG000|Reported Event|SADE Waiting Room|"children that will wait in the SADE waiting room~sensory adapted waiting room: The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers."
11313303|NCT03197129|EG001|Reported Event|Traditional Waiting Room|"children that will wait in the traditional waiting room~This waiting room consisted of ten seats in one row facing the reception desk, and was air-conditioned, well-lit, without posters or paintings on the walls, and no reading material."
11313304|NCT03197324|BG000|Baseline|Bexagliflozin and Digoxin, Then Digoxin Alone|Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, starting on Day 1 for 8 days, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 3
11313305|NCT03197324|BG001|Baseline|Digoxin Alone, Then Bexagliflozin and Digoxin|On Day 1, subjects received a single oral dose of 0.5 mg digoxin. Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, for 8 days starting on Day 15, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 17.
11313306|NCT03197324|BG002|Baseline|Total|Total of all reporting groups
11313307|NCT03197324|FG000|Participant Flow|Digoxin and Bexagliflozin Tablet, Then Digoxin Alone|"Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, starting on Day 1 for 8 days, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 3.~Subjects were discharged on Day 8.~On Day 19, subjects received a single oral dose of 0.5 mg digoxin and were discharged on Day 22."
11313308|NCT03197324|FG001|Participant Flow|Digoxin, Then Digoxin and Bexagliflozin|"On Day 1, subjects received a single oral dose of 0.5 mg digoxin. Subjects were discharged on Day 6.~Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, for 8 days starting on Day 15, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 17. Subjects were discharged on Day 22."
11313309|NCT03197324|OG000|Outcome|Digoxin Alone|Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
11313310|NCT03197324|OG001|Outcome|Digoxin With Bexagliflozin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)"
11313311|NCT03197324|EG000|Reported Event|Digoxin Alone|Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
11313312|NCT03197324|EG001|Reported Event|Digoxin With Bexagliflozin|"Bexagliflozin: Bexagliflozin tablets, 20 mg~Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)"
11313313|NCT03197376|BG000|Baseline|Pneumosil Lot 1|Three doses of Pneumosil Lot 1
11313314|NCT03197376|BG001|Baseline|Pneumosil Lot 2|Three doses of Pneumosil Lot 2
11313315|NCT03197376|BG002|Baseline|Pneumosil Lot 3|Three doses of Pneumosil Lot 3
11313316|NCT03197376|BG003|Baseline|Synflorix|Three doses of Synflorix
11313317|NCT03197376|BG004|Baseline|Total|Total of all reporting groups
11313318|NCT03197376|FG000|Participant Flow|Pneumosil Lot 1|10-Valent Pneumococcal Conjugate Vaccine Lot 1
11313319|NCT03197376|FG001|Participant Flow|Pneumosil Lot 2|10-Valent Pneumococcal Conjugate Vaccine Lot 2
11313320|NCT03197376|FG002|Participant Flow|Pneumosil Lot 3|10-Valent Pneumococcal Conjugate Vaccine Lot 3
11313321|NCT03197376|FG003|Participant Flow|Synflorix|Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
11313322|NCT03197376|OG000|Outcome|Lot 1|Three doses of Pneumosil Lot 1
11313323|NCT03197376|OG001|Outcome|Lot 2|Three doses of Pneumosil Lot 2
11313324|NCT03197376|OG002|Outcome|Lot 3|Three doses of Pneumosil Lot 3
11313325|NCT03197376|OG000|Outcome|Pneumosil|Three doses of Pneumosil
11313326|NCT03197376|OG001|Outcome|Synflorix|Three doses of Synflorix
11313327|NCT03197376|OG000|Outcome|Pneumosil|IgG GMC after three doses of Pneumosil
11313328|NCT03197376|OG001|Outcome|Synflorix|IgG GMC after three doses of Synflorix
11313329|NCT03197376|OG000|Outcome|Pneumosil|EPI vaccine immune responses after three doses of Pneumosil
11313330|NCT03197376|OG001|Outcome|Synflorix|EPI vaccine immune responses after three doses of Synflorix
11313331|NCT03197376|OG000|Outcome|Pneumosil|Subjects who have received one dose of Pneumosil vaccine
11313332|NCT03197376|OG001|Outcome|Synflorix|Subjects who have received one dose of Synflorix vaccine
11313333|NCT03197376|OG000|Outcome|Pneumosil|Subjects who have received two doses of Pneumosil vaccine
11313334|NCT03197376|OG001|Outcome|Synflorix|Subjects who have received two doses of Synflorix vaccine
11313335|NCT03197376|OG000|Outcome|Pneumosil|Subjects who have received three doses of Pneumosil vaccine
11313336|NCT03197376|OG001|Outcome|Synflorix|Subjects who have received three doses of Synflorix vaccine
11313337|NCT03197376|OG000|Outcome|Pneumosil|Three doses + 1 booster dose of Pneumosil
11313338|NCT03197376|OG001|Outcome|Synflorix|Three doses + 1 booster dose of Synflorix
11313339|NCT03197376|OG000|Outcome|Pneumosil|Primary series who have received three doses and booster cohort who have received three doses + a booster dose of Pneumosil
11313340|NCT03197376|OG001|Outcome|Synflorix|Primary series who have received three doses and booster cohort who have received three doses + a booster dose of Synflorix
11313341|NCT03197376|OG000|Outcome|4 Weeks Post Dose 3-Pneumosil|Three doses of Pneumosil in a subset
11313342|NCT03197376|OG001|Outcome|4 Weeks Post Booster-Pneumosil|Three doses + 1 booster dose of Pneumosil in a subset
11313343|NCT03197376|OG002|Outcome|4 Weeks Post Dose 3-Synflorix|Three doses of Synflorix in a subset
11313344|NCT03197376|OG003|Outcome|4 Weeks Post Booster-Synflorix|Three doses + 1 booster dose of Synflorix in a subset
11313345|NCT03197376|OG000|Outcome|Pneumosil|Three primary doses + 1 booster dose of Pneumosil
11313346|NCT03197376|OG001|Outcome|Synflorix|Three primary doses + 1 booster dose of Synflorix
11313347|NCT03197376|OG000|Outcome|4 Weeks Post Booster Dose-Pneumosil|Three doses + 1 booster dose of Pneumosil in a subset
11313348|NCT03197376|OG001|Outcome|One Year Post Booster-Pneumosil|Three doses + 1 booster dose of Pneumosil in a subset
11313349|NCT03197376|OG002|Outcome|4 Weeks Post Booster Dose-Synflorix|Three doses + 1 booster dose of Synflorix in a subset
11313350|NCT03197376|OG003|Outcome|One Year Post Booster-Synflorix|Three doses + 1 booster dose of Synflorix in a subset
11313351|NCT03197376|EG000|Reported Event|Pneumosil|Three doses of Pneumosil in primary series cohort and three + 1 booster dose in booster cohort
11313352|NCT03197376|EG001|Reported Event|Synflorix|Three doses of Synflorix in primary series cohort and three + 1 booster dose in booster cohort
11313353|NCT03197389|BG000|Baseline|Cohort A1|"Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313354|NCT03197389|BG001|Baseline|Cohort A2|"Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313355|NCT03197389|BG002|Baseline|Cohort A3|"Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313356|NCT03197389|BG003|Baseline|Cohort B1|"Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11335885|NCT03558230|BG002|Baseline|Total|Total of all reporting groups
11313357|NCT03197389|BG004|Baseline|Cohort B2|"Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313358|NCT03197389|BG005|Baseline|Cohort B3|"Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313359|NCT03197389|BG006|Baseline|Total|Total of all reporting groups
11313360|NCT03197389|FG000|Participant Flow|Cohort A1|"Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313361|NCT03197389|FG001|Participant Flow|Cohort A2|"Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313362|NCT03197389|FG002|Participant Flow|Cohort A3|"Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313363|NCT03197389|FG003|Participant Flow|Cohort B1|"Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313364|NCT03197389|FG004|Participant Flow|Cohort B2|"Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313365|NCT03197389|FG005|Participant Flow|Cohort B3|"Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313366|NCT03197389|OG000|Outcome|Cohort A1|"Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313367|NCT03197389|OG001|Outcome|Cohort A2|"Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313368|NCT03197389|OG002|Outcome|Cohort A3|"Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11094864|NCT01554891|BG002|Baseline|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
11094865|NCT01554891|BG003|Baseline|Total|Total of all reporting groups
11094866|NCT01554891|FG000|Participant Flow|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
11094867|NCT01554891|FG001|Participant Flow|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
11094868|NCT01554891|FG002|Participant Flow|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
11094869|NCT01554891|OG000|Outcome|Test-Retest Reliability of SAFE-TBI|Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
11094870|NCT01554891|OG000|Outcome|Comparison of SAFE-TBI and VA Screen|Veterans
11094871|NCT01554891|OG000|Outcome|Sensitivity and Specificity of SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
11094872|NCT01554891|EG000|Reported Event|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
11094873|NCT01554891|EG001|Reported Event|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
11094874|NCT01554891|EG002|Reported Event|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
11094875|NCT01554904|BG000|Baseline|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
11094876|NCT01554904|FG000|Participant Flow|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
11094877|NCT01554904|OG000|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
11094878|NCT01554904|EG000|Reported Event|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
11094879|NCT01554982|BG000|Baseline|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
11313369|NCT03197389|OG003|Outcome|Cohort B1|"Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313370|NCT03197389|OG004|Outcome|Cohort B2|"Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313371|NCT03197389|OG005|Outcome|Cohort B3|"Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313372|NCT03197389|EG000|Reported Event|Cohort A1|"Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313373|NCT03197389|EG001|Reported Event|Cohort A2|"Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313374|NCT03197389|EG002|Reported Event|Cohort A3|"Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313375|NCT03197389|EG003|Reported Event|Cohort B1|"Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313376|NCT03197389|EG004|Reported Event|Cohort B2|"Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313377|NCT03197389|EG005|Reported Event|Cohort B3|"Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery.~Pembrolizumab: Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2."
11313378|NCT03197558|BG000|Baseline|Tube Insertion Using Tube Delivery System (TDS)|"Active Tymbion iontophoresis and tubes using the TDS~Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement."
11313379|NCT03197558|FG000|Participant Flow|Tube Insertion Using Tube Delivery System (TDS)|"Active Tymbion iontophoresis and tubes using the TDS~Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement."
11313380|NCT03197558|OG000|Outcome|Tube Insertion Using Tube Delivery System (TDS)|"Active Tymbion iontophoresis and tubes using the TDS~Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement."
11313381|NCT03197558|EG000|Reported Event|Tube Insertion Using Tube Delivery System (TDS)|"Active Tymbion iontophoresis and tubes using the TDS~Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement."
10827162|NCT00107978|FG001|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
11313382|NCT03197883|BG000|Baseline|Test Product|Participants dispensed a pea-sized quantity of test product (approximately 0.6-1 g) onto the fingertips and applied twice daily (morning and evening) to the full face after cleansing. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen; approximately 0.6 to 1.0 g) on the full face in the morning (after application of test product) and at lunchtime.
11313383|NCT03197883|BG001|Baseline|No Treatment|Participants dispensed approximately 0.6 to 1.0 g of cleanser into the hands, worked into a lather, massaged onto the full face (wet skin), and rinsed with water, twice a day (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
11313384|NCT03197883|BG002|Baseline|Total|Total of all reporting groups
11313385|NCT03197883|FG000|Participant Flow|Test Product|Participants applied a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11313386|NCT03197883|FG001|Participant Flow|No Treatment|Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
11313387|NCT03197883|OG000|Outcome|Test Product|Participants applied a pea-sized quantity of test product (approximately 0.6-1 g) topically onto the fingertips twice daily (morning and evening) to the full face after cleansing. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11313388|NCT03197883|OG001|Outcome|No Treatment|Participants had their face wet with water and a small amount of facial cleanser (approximately 0.6-1 g) into lather. It was massaged topically onto wet skin and rinsed with water twice daily (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
11313389|NCT03197883|EG000|Reported Event|Test Product|Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
11313390|NCT03197883|EG001|Reported Event|No Treatment|Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Massage topically onto wet skin and rinse with water twice daily (morning and evening). After cleansing, participants will apply a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
11313391|NCT03198000|BG000|Baseline|F#13418-148/F#13418-158|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%
11313392|NCT03198000|BG001|Baseline|F#13418-148/F#PF004390|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%
11313393|NCT03198000|BG002|Baseline|F#13418-158/F#PF004390|Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%
11313394|NCT03198000|BG003|Baseline|Total|Total of all reporting groups
11313395|NCT03198000|FG000|Participant Flow|F#13418-148/F#13418-158|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%
11313396|NCT03198000|FG001|Participant Flow|F#13418-148/F#PF004390|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%
11313397|NCT03198000|FG002|Participant Flow|F#13418-158/F#PF004390|Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%
11313398|NCT03198000|OG000|Outcome|F# PF004390 Eye Drops|Active Comparator - Tetrahydrozoline 0.05%
11313399|NCT03198000|OG001|Outcome|F# 13418-148 Eye Drops|Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%
11313400|NCT03198000|OG002|Outcome|F#13418-158 Eye Drops|Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%
11313401|NCT03198000|EG000|Reported Event|F#13418-148/F#13418-158|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%
11313402|NCT03198000|EG001|Reported Event|F#13418-148/F#PF004390|Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%
11313403|NCT03198000|EG002|Reported Event|F#13418-158/F#PF004390|Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%
11313404|NCT03198221|BG000|Baseline|Group A|"Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.~Golytely: bowel preparation"
11313405|NCT03198221|BG001|Baseline|Group B|"Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Golytely: bowel preparation"
11313406|NCT03198221|BG002|Baseline|Group C|"Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.~Clenpiq: bowel preparation"
11313407|NCT03198221|BG003|Baseline|Group D|"Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Clenpiq: bowel preparation"
11313408|NCT03198221|BG004|Baseline|Total|Total of all reporting groups
11313409|NCT03198221|FG000|Participant Flow|Group A|"Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.~Golytely: bowel preparation"
11313410|NCT03198221|FG001|Participant Flow|Group B|"Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Golytely: bowel preparation"
11313411|NCT03198221|FG002|Participant Flow|Group C|"Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.~Clenpiq: bowel preparation"
11313412|NCT03198221|FG003|Participant Flow|Group D|"Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Clenpiq: bowel preparation"
11313413|NCT03198221|OG000|Outcome|Group A|"Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.~Golytely: bowel preparation"
11313414|NCT03198221|OG001|Outcome|Group B|"Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Golytely: bowel preparation"
11313415|NCT03198221|OG002|Outcome|Group C|"Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.~Clenpiq: bowel preparation"
11313416|NCT03198221|OG003|Outcome|Group D|"Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Clenpiq: bowel preparation"
10827163|NCT00107978|OG000|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
11313417|NCT03198221|EG000|Reported Event|Group A|"Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.~Golytely: bowel preparation"
10827164|NCT00107978|OG001|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
11094880|NCT01554982|FG000|Participant Flow|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
11313418|NCT03198221|EG001|Reported Event|Group B|"Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Golytely: bowel preparation"
11313419|NCT03198221|EG002|Reported Event|Group C|"Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.~Clenpiq: bowel preparation"
11313420|NCT03198221|EG003|Reported Event|Group D|"Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.~Clenpiq: bowel preparation"
11313421|NCT03198507|BG000|Baseline|RHB-105|RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
11313422|NCT03198507|BG001|Baseline|Active Comparator|Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
11313423|NCT03198507|BG002|Baseline|Total|Total of all reporting groups
11313424|NCT03198507|FG000|Participant Flow|RHB-105|RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
11313425|NCT03198507|FG001|Participant Flow|Active Comparator|Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
11313426|NCT03198507|OG000|Outcome|RHB-105|RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
11313427|NCT03198507|OG001|Outcome|Active Comparator|Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
11313428|NCT03198507|EG000|Reported Event|RHB-105|RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
11313429|NCT03198507|EG001|Reported Event|Active Comparator|Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
11094881|NCT01554982|OG000|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
11313430|NCT03198520|BG000|Baseline|Polymer Removable Partial Denture|"Evaluate the change in patient Oral Health-related Quality of Life while wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD)~Solvay Dental 360™: polymer Removable Partial Denture (RPD)"
11313431|NCT03198520|FG000|Participant Flow|Solvay Dental 360™: Polymer Removable Partial Denture (RPD)|"Solvay Dental 360™: polymer Removable Partial Denture (RPD)~All the participants wore Cobalt Chrome (CoCr) Removable Partial Dentures (RPD) at baseline before wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD)."
11313432|NCT03198520|OG000|Outcome|Solvay Dental 360™: Polymer Removable Partial Denture|Solvay Dental 360™: polymer Removable Partial Denture (RPD)
11313433|NCT03198520|OG001|Outcome|Cobalt Chrome (CoCr) Removable Partial Denture (RPD)|Cobalt Chrome (CoCr) Removable Partial Denture (RPD)
11313434|NCT03198520|OG001|Outcome|Cobalt Chrome (CoCr) Removable Partial Denture (RPD)|cobalt chrome (CoCr) removable partial denture (RPD)
11313435|NCT03198520|OG000|Outcome|Baseline Oral Exam: Cobalt Chrome (CoCr) Removable Partial Denture|Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium
11313436|NCT03198520|OG001|Outcome|Final Fitting: Solvay Dental 360™: Polymer Removable Partial Denture|Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium
11313437|NCT03198520|OG002|Outcome|Visit 6: Solvay Dental 360™: Polymer Removable Partial Denture|Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium
11313438|NCT03198520|OG003|Outcome|Visit 7: Solvay Dental 360™: Polymer Removable Partial Denture|Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium
11313439|NCT03198520|OG004|Outcome|Visit 8: Solvay Dental 360™: Polymer Removable Partial Denture|Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium
11313440|NCT03198520|OG000|Outcome|Solvay Dental 360™: Polymer Removable Partial Denture|Solvay Dental 360™ polymer Removable Partial Denture (RPD)
11313441|NCT03198520|EG000|Reported Event|Polymer Removable Partial Denture|Solvay Dental 360™ polymer Removable Partial Denture (RPD)
11313442|NCT03198715|BG000|Baseline|DS-1040b 0.6 mg|Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
11313443|NCT03198715|BG001|Baseline|DS-1040b 1.2 mg|Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
11313444|NCT03198715|BG002|Baseline|DS-1040b 2.4 mg|Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
11313445|NCT03198715|BG003|Baseline|DS-1040b 4.8 mg|Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
11313446|NCT03198715|BG004|Baseline|Placebo|Participants who received a single, intravenous infusion of placebo.
11313447|NCT03198715|BG005|Baseline|Total|Total of all reporting groups
11313448|NCT03198715|FG000|Participant Flow|DS-1040b 0.6 mg|Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
11313449|NCT03198715|FG001|Participant Flow|DS-1040b 1.2 mg|Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
11313450|NCT03198715|FG002|Participant Flow|DS-1040b 2.4 mg|Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
11313451|NCT03198715|FG003|Participant Flow|DS-1040b 4.8 mg|Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
11313452|NCT03198715|FG004|Participant Flow|Placebo|Participants who received a single, intravenous infusion of placebo.
11313453|NCT03198715|OG000|Outcome|DS-1040b 0.6 mg|Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
11313454|NCT03198715|OG001|Outcome|DS-1040b 1.2 mg|Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
11313455|NCT03198715|OG002|Outcome|DS-1040b 2.4 mg|Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
11313456|NCT03198715|OG003|Outcome|DS-1040b 4.8 mg|Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
11313457|NCT03198715|OG004|Outcome|Placebo|Participants who received a single, intravenous infusion of placebo.
11313458|NCT03198715|EG000|Reported Event|DS-1040b 0.6 mg|Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
11313459|NCT03198715|EG001|Reported Event|DS-1040b 1.2 mg|Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
11313460|NCT03198715|EG002|Reported Event|DS-1040b 2.4 mg|Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
11313461|NCT03198715|EG003|Reported Event|DS-1040b 4.8 mg|Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
11313462|NCT03198715|EG004|Reported Event|Placebo|Participants who received a single, intravenous infusion of placebo.
11313463|NCT03198754|BG000|Baseline|Circadian Active Bright White Light (BWL)|PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313464|NCT03198754|BG001|Baseline|Circadian Inactive Dim White Light (DWL)|Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313465|NCT03198754|BG002|Baseline|Total|Total of all reporting groups
11313466|NCT03198754|FG000|Participant Flow|Circadian Active Bright White Light (BWL)|PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313467|NCT03198754|FG001|Participant Flow|Circadian Inactive Dim White Light (DWL)|Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313468|NCT03198754|OG000|Outcome|Circadian Active Bright White Light (BWL)|PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313469|NCT03198754|OG001|Outcome|Circadian Inactive Dim White Light (DWL)|Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313470|NCT03198754|EG000|Reported Event|Circadian Active Bright White Light (BWL)|PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313471|NCT03198754|EG001|Reported Event|Circadian Inactive Dim White Light (DWL)|Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
11313472|NCT03198767|BG000|Baseline|Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
11313473|NCT03198767|BG001|Baseline|Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
11313474|NCT03198767|BG002|Baseline|Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
11313475|NCT03198767|BG003|Baseline|Part A: LIK066 + P1: 8% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
11313476|NCT03198767|BG004|Baseline|Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
11313477|NCT03198767|BG005|Baseline|Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
11313478|NCT03198767|BG006|Baseline|Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
11313479|NCT03198767|BG007|Baseline|Total|Total of all reporting groups
11313480|NCT03198767|FG000|Participant Flow|Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
11313481|NCT03198767|FG001|Participant Flow|Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
11313482|NCT03198767|FG002|Participant Flow|Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
11313483|NCT03198767|FG003|Participant Flow|Part A: LIK066 + P1: 8% CHO|Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
11313484|NCT03198767|FG004|Participant Flow|Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
11313485|NCT03198767|FG005|Participant Flow|Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
11313486|NCT03198767|FG006|Participant Flow|Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS|Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
11313487|NCT03198767|OG000|Outcome|Part A: LIK066 + 50% CHO|Part A: LIK066 + 50% carbohydrate CHO
11313488|NCT03198767|OG001|Outcome|Part A: LIK066 + 25% CHO|Part A: LIK066 + 25% carbohydrate CHO
11313489|NCT03198767|OG002|Outcome|Part A: LIK066 + 0% CHO|Part A: LIK066 + 0% carbohydrate CHO
11313490|NCT03198767|OG003|Outcome|Part B: LIK066 + 50% CHO + NS|Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
11313491|NCT03198767|OG004|Outcome|Part B: LIK066 + 50% CHO + PS|Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
11313492|NCT03198767|OG005|Outcome|Part B: LIK066 + 50% CHO CC|Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
11313493|NCT03198767|EG000|Reported Event|Part A: LIK066 + 50% CHO|Part A: LIK066 + 50% carbohydrate CHO
11313494|NCT03198767|EG001|Reported Event|Part A: LIK066 + 25% CHO|Part A: LIK066 + 25% carbohydrate CHO
11313495|NCT03198767|EG002|Reported Event|Part A: LIK066 + 0% CHO|Part A: LIK066 + 0% carbohydrate CHO
11313496|NCT03198767|EG003|Reported Event|Part A: LIK066 + 8% CHO|Part A: LIK066 + 8% carbohydrate CHO
11313497|NCT03198767|EG004|Reported Event|Part B: LIK066 + 50% CHO + NS|Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
11313498|NCT03198767|EG005|Reported Event|Part B: LIK066 + 50% CHO + PS|Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
11313499|NCT03198767|EG006|Reported Event|Part B: LIK066 + 50% CHO CC|Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
11313500|NCT03198871|BG000|Baseline|Acetaminophen Injectable Product|"Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group~Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively"
11313501|NCT03198871|BG001|Baseline|Sodium Chloride 0.9%, Intravenous|"Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group~Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively."
11313502|NCT03198871|BG002|Baseline|Total|Total of all reporting groups
11094882|NCT01554982|EG000|Reported Event|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
11313503|NCT03198871|FG000|Participant Flow|Acetaminophen Injectable Product|"Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group~Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively"
11313504|NCT03198871|FG001|Participant Flow|Sodium Chloride 0.9%, Intravenous|"Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group~Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively."
11313505|NCT03198871|OG000|Outcome|Acetaminophen Injectable Product|"Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group~Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively"
11313506|NCT03198871|OG001|Outcome|Sodium Chloride 0.9%, Intravenous|"Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group~Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively."
11313507|NCT03198871|EG000|Reported Event|Acetaminophen Injectable Product|"Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group~Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively"
11313508|NCT03198871|EG001|Reported Event|Sodium Chloride 0.9%, Intravenous|"Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group~Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively."
11335886|NCT03558230|FG000|Participant Flow|Vibration|"The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Vibration: Vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
11313509|NCT03198884|BG000|Baseline|Retrospective Chart Review|We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks.
11313510|NCT03198884|FG000|Participant Flow|Retrospective Chart Review|We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks.
11313511|NCT03198884|OG000|Outcome|Retrospective Chart Review|We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks.
11313512|NCT03198884|OG000|Outcome|Week 24|Data shows mean change in CD4+ cell count (cells/μL) from baseline to week 24.
11313513|NCT03198884|OG001|Outcome|Week 36|Data shows mean change in CD4+ cell count (cells/μL) from baseline to week 36.
11313514|NCT03198884|OG002|Outcome|Week 48|Data shows mean change in CD4+ cell count (cells/μL) from baseline to week 48.
11313515|NCT03198884|OG000|Outcome|Adverse Events|As per the studay protocol, an adverse event (AE) is an untoward medical occurence in a patient administered a medicinal product.
11313516|NCT03198884|OG000|Outcome|Analysis of HIV RNA at Week 24|At week 24, 75% of subjects had an RNA of < 50 copies/mL. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure.
11313517|NCT03198884|OG001|Outcome|Analysis of HIV RNA at Week 36|At week 36, 65% of subjects had an RNA of < 50 copies/mL. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure.
11313518|NCT03198884|OG002|Outcome|Analysis of HIV RNA at Week 48|At week 48, 95% of subjects had an RNA of < 50 copies/mL. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure.
11313519|NCT03198884|OG000|Outcome|Analysis of Serum Creatinine at Week 24|There were no significant differences in creatinine clearance from baseline to 24 weeks.
11313520|NCT03198884|OG001|Outcome|Analysis of Serum Creatinine at Week 36|There were no significant differences in creatinine clearance from baseline to 36 weeks.
11313521|NCT03198884|OG002|Outcome|Analyis of Serum Creatinine at Week 48|There were no significant differences in creatinine clearance from baseline to 48 weeks.
11313522|NCT03198884|EG000|Reported Event|Retrospective Chart Review|We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks.
11313523|NCT03199079|BG000|Baseline|Group 1: Non-pregnant Women|"Non-pregnant women with normal pelvic floor~Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor"
11313524|NCT03199079|BG001|Baseline|Group 2: Pregnant Women|"Pregnant women; 22-29 weeks of pregnancy~Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor"
11313525|NCT03199079|BG002|Baseline|Total|Total of all reporting groups
11313526|NCT03199079|FG000|Participant Flow|Non-pregnant Women|Adult women age 21-44 years; 10 non-pregnant women
11313527|NCT03199079|FG001|Participant Flow|Pregnant Women|Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
11313528|NCT03199079|OG000|Outcome|Non-pregnant Women|Adult women age 21-44 years; 10 non-pregnant women
11313529|NCT03199079|OG001|Outcome|Pregnant Women|Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
11313530|NCT03199079|EG000|Reported Event|Non-pregnant Women|Adult women age 21-44 years; 10 non-pregnant women
11313531|NCT03199079|EG001|Reported Event|Pregnant Women|Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
11313532|NCT03199118|BG000|Baseline|CAF+SCTG+PRF|"Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313533|NCT03199118|BG001|Baseline|CAF+SCTG|"Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313534|NCT03199118|BG002|Baseline|Total|Total of all reporting groups
11313535|NCT03199118|FG000|Participant Flow|CAF+SCTG+PRF|"Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313536|NCT03199118|FG001|Participant Flow|CAF+SCTG|"Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313537|NCT03199118|OG000|Outcome|Intervention: CAF+SCTG+PRF|"Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313538|NCT03199118|OG001|Outcome|Control Group:CAF+SCTG|"Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313539|NCT03199118|OG000|Outcome|CAF+SCTG+PRF|"Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313540|NCT03199118|OG001|Outcome|CAF+SCTG|"Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313541|NCT03199118|OG000|Outcome|CAF+SCTG+PRF|"Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313542|NCT03199118|OG000|Outcome|CAF+SCTG+PRF|"The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession~platelet rich fibrin: in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession"
11313543|NCT03199118|OG001|Outcome|CAF+SCTG|"Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313544|NCT03199118|EG000|Reported Event|CAF+SCTG+PRF|"Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane~Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)"
11313545|NCT03199118|EG001|Reported Event|CAF+SCTG|"Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)~CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession"
11313546|NCT03199872|BG000|Baseline|Experimental: RV001V|"RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.~RV001V: Sc injection"
11313547|NCT03199872|FG000|Participant Flow|Experimental: RV001V|"RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.~RV001V: A total of 11 s.c.injection with RV001V. The first 6 injections were given every 2 weeks, whereas the remaining 5 vaccinations were administered with 4 weeks between each injection."
11313548|NCT03199872|OG000|Outcome|Experimental: RV001V|"RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.~RV001V: Sc injection"
11313549|NCT03199872|EG000|Reported Event|Experimental: RV001V|"RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.~RV001V: Sc injection"
11313550|NCT03199911|BG000|Baseline|Topical Antibiotic Ointment|The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
11313551|NCT03199911|BG001|Baseline|Topical Non-Antibiotic Ointment|The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
11313552|NCT03199911|BG002|Baseline|Total|Total of all reporting groups
11313553|NCT03199911|FG000|Participant Flow|Topical Antibiotic Ointment|The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
11313554|NCT03199911|FG001|Participant Flow|Topical Non-Antibiotic Ointment|The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
11313555|NCT03199911|OG000|Outcome|Topical Antibiotic Ointment|The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
11313556|NCT03199911|OG001|Outcome|Topical Non-Antibiotic Ointment|The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
11313557|NCT03199911|EG000|Reported Event|Topical Antibiotic Ointment|The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.
11313558|NCT03199911|EG001|Reported Event|Topical Non-Antibiotic Ointment|The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.
11333320|NCT03512028|FG000|Participant Flow|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-8.~RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333321|NCT03512028|FG001|Participant Flow|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-8.~Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333322|NCT03512028|OG000|Outcome|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-8.~RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333323|NCT03512028|OG001|Outcome|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-8.~Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333324|NCT03512028|EG000|Reported Event|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-8.~RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333325|NCT03512028|EG001|Reported Event|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-8.~Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.~Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8"
11333326|NCT03512041|BG000|Baseline|RLIC - 5 Cycles|"Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants underg"
11333327|NCT03512041|BG001|Baseline|RLIC - 4 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11335887|NCT03558230|FG001|Participant Flow|No Vibration|"The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Placebo (for vibration): No vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
11313559|NCT03199963|BG000|Baseline|BHR-700 (0.2% 4-OHT Gel)|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313560|NCT03199963|BG001|Baseline|Matching Placebo Gel|"An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.~Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT."
11313561|NCT03199963|BG002|Baseline|Total|Total of all reporting groups
11313562|NCT03199963|FG000|Participant Flow|BHR-700 (0.2% 4-OHT Gel)|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313563|NCT03199963|FG001|Participant Flow|Matching Placebo Gel|"An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.~Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT."
11313564|NCT03199963|OG000|Outcome|BHR-700 (0.2% 4-OHT Gel)|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313565|NCT03199963|OG001|Outcome|Matching Placebo Gel|"An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.~Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT."
11313566|NCT03199963|EG000|Reported Event|BHR-700 (0.2% 4-OHT Gel) in Blinded Phase|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313567|NCT03199963|EG001|Reported Event|Matching Placebo Gel in Blinded Phase|"An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.~Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT."
11313568|NCT03199963|EG002|Reported Event|Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313569|NCT03199963|EG003|Reported Event|Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase|"The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.~4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel"
11313570|NCT03200366|BG000|Baseline|Tailored DVD|"Tailored digital video disc (DVD)~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
11313571|NCT03200366|BG001|Baseline|Tailored DVD + Patient Navigation|"Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.~Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support."
11313572|NCT03200366|BG002|Baseline|Usual Care|Care normally provided by a nurse in the endoscopy department of the healthcare system
11313573|NCT03200366|BG003|Baseline|Total|Total of all reporting groups
11313574|NCT03200366|FG000|Participant Flow|Tailored DVD|"Tailored digital video disc (DVD)~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
11313575|NCT03200366|FG001|Participant Flow|Tailored DVD + Patient Navigation|"Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.~Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support."
11313576|NCT03200366|FG002|Participant Flow|Usual Care|Care normally provided by a nurse in the endoscopy department of the healthcare system
11313577|NCT03200366|OG000|Outcome|Tailored DVD|"Tailored digital video disc (DVD)~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
11313578|NCT03200366|OG001|Outcome|Tailored DVD + Patient Navigation|"Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system~DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.~Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support."
11313579|NCT03200366|OG002|Outcome|Usual Care|Care normally provided by a nurse in the endoscopy department of the healthcare system
11313580|NCT03200366|OG000|Outcome|Tailored DVD|"Tailored digital video disc (DVD)~Tailored DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
11313581|NCT03200366|OG001|Outcome|Tailored DVD + Patient Navigation|"Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system~Tailored DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.~Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support."
11313582|NCT03200366|EG000|Reported Event|Tailored DVD|"Tailored digital video disc (DVD)~Tailored DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
11313583|NCT03200366|EG001|Reported Event|Tailored DVD + Patient Navigation|"Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system~Tailored DVD: A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.~Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support."
11313584|NCT03200366|EG002|Reported Event|Usual Care|Care normally provided by a nurse in the endoscopy department of the healthcare system
11313585|NCT03200535|BG000|Baseline|Usual Care|Usual care
11313586|NCT03200535|BG001|Baseline|"Electronic Health Record Gaps"|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient"
11313587|NCT03200535|BG002|Baseline|Bulk Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent"
11313588|NCT03200535|BG003|Baseline|Personalized Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent~Dietician call: Patients will receive a personalized call by a registered dietitian"
11313589|NCT03200535|BG004|Baseline|Total|Total of all reporting groups
11313590|NCT03200535|FG000|Participant Flow|Usual Care|Usual care
11313591|NCT03200535|FG001|Participant Flow|"Electronic Health Record Gaps"|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient"
11313592|NCT03200535|FG002|Participant Flow|Bulk Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent"
11313593|NCT03200535|FG003|Participant Flow|Personalized Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent~Dietician call: Patients will receive a personalized call by a registered dietitian"
11313594|NCT03200535|OG000|Outcome|Usual Care|Usual care
11094883|NCT01555125|BG000|Baseline|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
11094884|NCT01555125|BG001|Baseline|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing
11094885|NCT01555125|BG002|Baseline|Placebo|Patients received placebo secukinumab (2 s.c. injections) at each dosing
11094886|NCT01555125|BG003|Baseline|Total|Total of all reporting groups
11094887|NCT01555125|FG000|Participant Flow|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
11094888|NCT01555125|FG001|Participant Flow|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing
11094889|NCT01555125|FG002|Participant Flow|Placebo - AIN457 150mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
11094890|NCT01555125|FG003|Participant Flow|Placebo - AIN457 300mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
11094891|NCT01555125|FG004|Participant Flow|Placebo|Patients received placebo secukinumab (2 s.c. injections) at each dosing
11094892|NCT01555125|OG000|Outcome|AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
11094893|NCT01555125|OG001|Outcome|AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing
11094894|NCT01555125|OG002|Outcome|Placebo|Patients received placebo secukinumab (2 s.c. injections) at each dosing
11094895|NCT01555125|OG002|Outcome|Placebo-AIN457 150mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
11094896|NCT01555125|OG003|Outcome|Placebo-AIN457 300mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
11094897|NCT01555125|OG003|Outcome|Placebo - AIN457 300 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
11094898|NCT01555125|OG002|Outcome|Placebo-AIN457 150 mg|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study
11094899|NCT01555125|OG004|Outcome|Placebo|Patients received placebo secukinumab (2 s.c. injections) at each dosing
11094900|NCT01555125|EG000|Reported Event|Induction AIN457 150 mg|Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing
11094901|NCT01555125|EG001|Reported Event|Induction AIN457 300 mg|Patients received two secukinumab 150 mg s.c. injections at each dosing
11094902|NCT01555125|EG002|Reported Event|Induction Placebo|placebo secukinumab (2 s.c. injections) at each dosing
11094903|NCT01555125|EG003|Reported Event|Entire Any AIN457 150 mg|Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups
11094904|NCT01555125|EG004|Reported Event|Entire Any AIN457 300 mg|Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups
11094905|NCT01555138|BG000|Baseline|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11094906|NCT01555138|BG001|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
11094907|NCT01555138|BG002|Baseline|Total|Total of all reporting groups
11094908|NCT01555138|FG000|Participant Flow|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11094909|NCT01555138|FG001|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
11094910|NCT01555138|OG000|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11094911|NCT01555138|OG001|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
11094912|NCT01555138|EG000|Reported Event|Indacaterol|Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
11094913|NCT01555138|EG001|Reported Event|Salmeterol/Fluticasone|Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
11094914|NCT01555151|BG000|Baseline|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
11094915|NCT01555151|BG001|Baseline|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
11094916|NCT01555151|BG002|Baseline|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
11094917|NCT01555151|BG003|Baseline|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
11094918|NCT01555151|BG004|Baseline|Total|Total of all reporting groups
11094919|NCT01555151|FG000|Participant Flow|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
11094920|NCT01555151|FG001|Participant Flow|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
11094921|NCT01555151|FG002|Participant Flow|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
11094922|NCT01555151|FG003|Participant Flow|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
11313595|NCT03200535|OG001|Outcome|"Electronic Health Record Gaps"|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient"
11313596|NCT03200535|OG002|Outcome|Bulk Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent"
11313597|NCT03200535|OG003|Outcome|Personalized Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent~Dietician call: Patients will receive a personalized call by a registered dietitian"
11313598|NCT03200535|EG000|Reported Event|Usual Care|Usual care
11313599|NCT03200535|EG001|Reported Event|"Electronic Health Record Gaps"|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient"
11313600|NCT03200535|EG002|Reported Event|Bulk Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent"
11313601|NCT03200535|EG003|Reported Event|Personalized Outreach|"Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian~EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient~Bulk outreach: A bulk letter or email will be sent~Dietician call: Patients will receive a personalized call by a registered dietitian"
11313602|NCT03200860|BG000|Baseline|Empagliflozin|"Empagliflozin 10 mg daily, oral, 30 days~Empagliflozin 10 MG: 10 mg daily, oral, 30 days"
11313603|NCT03200860|BG001|Baseline|Placebo|"Matching Placebo 10 mg daily, oral, 30 days~Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days"
11313604|NCT03200860|BG002|Baseline|Total|Total of all reporting groups
11313605|NCT03200860|FG000|Participant Flow|Empagliflozin|"Empagliflozin 10 mg daily, oral, 30 days~Empagliflozin 10 MG: 10 mg daily, oral, 30 days"
11313606|NCT03200860|FG001|Participant Flow|Placebo|"Matching Placebo 10 mg daily, oral, 30 days~Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days"
11313607|NCT03200860|OG000|Outcome|Empagliflozin|"Empagliflozin 10 mg daily, oral, 30 days~Empagliflozin 10 MG: 10 mg daily, oral, 30 days"
11313608|NCT03200860|OG001|Outcome|Placebo|"Matching Placebo 10 mg daily, oral, 30 days~Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days"
11313609|NCT03200860|EG000|Reported Event|Empagliflozin|"Empagliflozin 10 mg daily, oral, 30 days~Empagliflozin 10 MG: 10 mg daily, oral, 30 days"
11313610|NCT03200860|EG001|Reported Event|Placebo|"Matching Placebo 10 mg daily, oral, 30 days~Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days"
11313611|NCT03200912|BG000|Baseline|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.015% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11313612|NCT03200912|BG001|Baseline|Picato (Ingenol Mebutate)|"Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11094923|NCT01555151|OG000|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
11313613|NCT03200912|BG002|Baseline|Vehicle Gel|"Vehicle gel of the test product~Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11313614|NCT03200912|BG003|Baseline|Total|Total of all reporting groups
11313615|NCT03200912|FG000|Participant Flow|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.015% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11313616|NCT03200912|FG001|Participant Flow|Picato (Ingenol Mebutate)|"Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11313617|NCT03200912|FG002|Participant Flow|Vehicle Gel|"Vehicle gel of the test product~Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11313618|NCT03200912|OG000|Outcome|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.015% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11313619|NCT03200912|OG001|Outcome|Picato (Ingenol Mebutate)|"Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11313620|NCT03200912|OG002|Outcome|Vehicle Gel|"Vehicle gel of the test product~Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11313621|NCT03200912|EG000|Reported Event|Generic Ingenol Mebutate|"Generic ingenol mebutate gel, 0.015% [Test]~Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand"
11313622|NCT03200912|EG001|Reported Event|Picato (Ingenol Mebutate)|"Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]~Ingenol Mebutate (Picato®): Brand product"
11313623|NCT03200912|EG002|Reported Event|Vehicle Gel|"Vehicle gel of the test product~Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments."
11335888|NCT03558230|OG000|Outcome|Vibration|"The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Vibration: Vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
11313624|NCT03200925|BG000|Baseline|Group A - no Video Group|"Group A will be asked a short survey:~their intention to practice skin to skin at the time of delivery~if they participated in skin to skin in a previous pregnancy~if they had any formal education about skin to skin~if they did have formal education was it either~a.) Provided at a prenatal appointment,~b.) A formal class led by either a nurse or a lactation consultant.~We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313625|NCT03200925|BG001|Baseline|Group B - Video Group|"Group B will be asked the same short survey as group A. The patient would then immediately watch Jumping into Kangaroo Care, and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313626|NCT03200925|BG002|Baseline|Total|Total of all reporting groups
11313627|NCT03200925|FG000|Participant Flow|Group A - no Video Group|"Group A will be asked a short survey:~their intention to practice skin to skin at the time of delivery~if they participated in skin to skin in a previous pregnancy~if they had any formal education about skin to skin~if they did have formal education was it either~a.) Provided at a prenatal appointment,~b.) A formal class led by either a nurse or a lactation consultant.~We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313628|NCT03200925|FG001|Participant Flow|Group B - Video Group|"Group B will be asked the same short survey as group A. The patient would then immediately watch Jumping into Kangaroo Care, and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313629|NCT03200925|OG000|Outcome|Group A - no Video Group|"Group A will be asked a short survey:~their intention to practice skin to skin at the time of delivery~if they participated in skin to skin in a previous pregnancy~if they had any formal education about skin to skin~if they did have formal education was it either~a.) Provided at a prenatal appointment,~b.) A formal class led by either a nurse or a lactation consultant.~We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313630|NCT03200925|OG001|Outcome|Group B - Video Group|"Group B will be asked the same short survey as group A. The patient would then immediately watch Jumping into Kangaroo Care, and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313631|NCT03200925|EG000|Reported Event|Group A - no Video Group|"Group A will be asked a short survey:~their intention to practice skin to skin at the time of delivery~if they participated in skin to skin in a previous pregnancy~if they had any formal education about skin to skin~if they did have formal education was it either~a.) Provided at a prenatal appointment,~b.) A formal class led by either a nurse or a lactation consultant.~We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
11313632|NCT03200925|EG001|Reported Event|Group B - Video Group|"Group B will be asked the same short survey as group A. The patient would then immediately watch Jumping into Kangaroo Care, and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes)."
10827165|NCT00107978|EG000|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
11313633|NCT03201003|BG000|Baseline|AR101|"AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
11313634|NCT03201003|BG001|Baseline|Placebo|A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
11313635|NCT03201003|BG002|Baseline|Total|Total of all reporting groups
11313636|NCT03201003|FG000|Participant Flow|AR101|"AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
11313637|NCT03201003|FG001|Participant Flow|Placebo|A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
11313638|NCT03201003|OG000|Outcome|AR101|"AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
11313639|NCT03201003|OG001|Outcome|Placebo|A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
11313640|NCT03201003|EG000|Reported Event|AR101|"AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.~The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase."
11313641|NCT03201003|EG001|Reported Event|Placebo|A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
11313642|NCT03201211|BG000|Baseline|10-10-10-AS|Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313643|NCT03201211|BG001|Baseline|10-10-3-AS|Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313644|NCT03201211|BG002|Baseline|PLACEBO|Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
10827166|NCT00107978|EG001|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
10827167|NCT00107991|BG000|Baseline|Etanercept|50 mg/week subcutaneously
10827168|NCT00107991|FG000|Participant Flow|Etanercept|50 mg/week subcutaneously
10827169|NCT00107991|OG000|Outcome|Etanercept|50 mg/week subcutaneously
11313645|NCT03201211|BG003|Baseline|Total|Total of all reporting groups
11313646|NCT03201211|FG000|Participant Flow|10-10-10-AS|Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313647|NCT03201211|FG001|Participant Flow|10-10-3-AS|Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313648|NCT03201211|FG002|Participant Flow|PLACEBO|Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
11313649|NCT03201211|OG000|Outcome|10-10-10-AS|Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313650|NCT03201211|OG001|Outcome|10-10-3-AS|Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313651|NCT03201211|OG002|Outcome|PLACEBO|Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
11313652|NCT03201211|EG000|Reported Event|10-10-10-AS|Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313653|NCT03201211|EG001|Reported Event|10-10-3-AS|Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
11313654|NCT03201211|EG002|Reported Event|PLACEBO|Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
11313655|NCT03201562|BG000|Baseline|Crossover Sequence 1|Aceclidine+tropicamide combination Visit 1, Aceclidine Visit 2, Vehicle Visit 3
11313656|NCT03201562|BG001|Baseline|Crossover Sequence 2|Aceclidine Visit 1, Vehicle Visit 2, Aceclidine+tropicamide combination Visit 3
11313657|NCT03201562|BG002|Baseline|Crossover Sequence 3|Vehicle Visit 1, Aceclidine+tropicamide combination Visit 2, Aceclidine Visit 3
11313658|NCT03201562|BG003|Baseline|Total|Total of all reporting groups
11313659|NCT03201562|FG000|Participant Flow|Crossover Sequence 1|Aceclidine+tropicamide combination Visit 1, Aceclidine Visit 2, Vehicle Visit 3
11313660|NCT03201562|FG001|Participant Flow|Crossover Sequence 2|Aceclidine Visit 1, Vehicle Visit 2, Aceclidine+tropicamide combination Visit 3
11313661|NCT03201562|FG002|Participant Flow|Crossover Sequence 3|Vehicle Visit 1, Aceclidine+tropicamide combination Visit 2, Aceclidine Visit 3
11313662|NCT03201562|OG000|Outcome|Aceclidine+Tropicamide Combination|Aceclidine+tropicamide combination single dose
11313663|NCT03201562|OG001|Outcome|Aceclidine|Aceclidine single dose
11313664|NCT03201562|OG002|Outcome|Vehicle|Vehicle single dose
11313665|NCT03201562|EG000|Reported Event|Aceclidine+Tropicamide Combination|Aceclidine+tropicamide combination single dose
11313666|NCT03201562|EG001|Reported Event|Aceclidine|Aceclidine single dose
11313667|NCT03201562|EG002|Reported Event|Vehicle|Vehicle single dose
11313668|NCT03201809|BG000|Baseline|On-Q Catheter|"On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).~On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral"
11313669|NCT03201809|BG001|Baseline|Ultrasound Guided Pectoral Nerve Block|"Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection~Ultrasound guided pectoral nerve block: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection"
11313670|NCT03201809|BG002|Baseline|Total|Total of all reporting groups
11313671|NCT03201809|FG000|Participant Flow|On-Q Catheter|"On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).~On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral"
11313672|NCT03201809|FG001|Participant Flow|Ultrasound Guided Pectoral Nerve Block|"Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection~Ultrasound guided pectoral nerve block: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection"
11313673|NCT03201809|OG000|Outcome|On-Q Catheter|"On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).~On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral"
11313674|NCT03201809|OG001|Outcome|Ultrasound Guided Pectoral Nerve Block|"Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection~Ultrasound guided pectoral nerve block: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection"
11313675|NCT03201809|EG000|Reported Event|On-Q Catheter|"On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).~On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral"
11313676|NCT03201809|EG001|Reported Event|Ultrasound Guided Pectoral Nerve Block|"Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection~Ultrasound guided pectoral nerve block: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection"
11313677|NCT03201900|BG000|Baseline|Perampanel|Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
11313678|NCT03201900|FG000|Participant Flow|Perampanel|Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs).
11313679|NCT03201900|OG000|Outcome|Perampanel|Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
11313680|NCT03201900|EG000|Reported Event|Perampanel|Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
11313681|NCT03202134|BG000|Baseline|Opioid Free Anesthesia (OFA)|"The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.~opioid free anesthesia: general anesthesia blocking reflexes without using an opioid"
11313682|NCT03202134|BG001|Baseline|Opioid Anesthesia (OA)|OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
11313683|NCT03202134|BG002|Baseline|Total|Total of all reporting groups
11313684|NCT03202134|FG000|Participant Flow|Opioid Free Anesthesia (OFA)|"The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.~opioid free anesthesia: general anesthesia blocking reflexes without using an opioid"
11313685|NCT03202134|FG001|Participant Flow|Opioid Anesthesia (OA)|OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
11313686|NCT03202134|OG000|Outcome|Opioid Free Anesthesia (OFA)|"The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.~opioid free anesthesia: general anesthesia blocking reflexes without using an opioid"
11313687|NCT03202134|OG001|Outcome|Opioid Anesthesia (OA)|OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
11313688|NCT03202134|OG000|Outcome|Opioid Free Anesthesia (OFA)|"The method of reaching opioid free anesthesia (OFA): Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.~opioid free anesthesia: general anesthesia blocking reflexes without using an opioid"
11313689|NCT03202134|OG001|Outcome|Opioid Anesthesia (OA)|opioid anesthesia (OA) was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
11313690|NCT03202134|EG000|Reported Event|Opioid Free Anesthesia (OFA)|"The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.~opioid free anesthesia: general anesthesia blocking reflexes without using an opioid"
11313691|NCT03202134|EG001|Reported Event|Opioid Anesthesia (OA)|OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
11313692|NCT03202264|BG000|Baseline|TAPERMD|"80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities~TAPER: The intervention is medication reduction. This arm is comprised of:~Medication reconciliation~Identification of patient priorities for care~Identification of medications that are potentially appropriate for discontinuation/dose reduction~Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce~Identification of medications for trial of discontinuation/dose reduction (shared decision making)~Pause of medication and clinical monitoring"
11313693|NCT03202264|FG000|Participant Flow|TAPERMD|"80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities~TAPER: The intervention is medication reduction. This arm is comprised of:~Medication reconciliation~Identification of patient priorities for care~Identification of medications that are potentially appropriate for discontinuation/dose reduction~Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce~Identification of medications for trial of discontinuation/dose reduction (shared decision making)~Pause of medication and clinical monitoring"
10827170|NCT00107991|EG000|Reported Event|Etanercept|50 mg/week subcutaneously
11313694|NCT03202264|OG000|Outcome|TAPERMD|"80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities~TAPER: The intervention is medication reduction. This arm is comprised of:~Medication reconciliation~Identification of patient priorities for care~Identification of medications that are potentially appropriate for discontinuation/dose reduction~Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce~Identification of medications for trial of discontinuation/dose reduction (shared decision making)~Pause of medication and clinical monitoring"
11313695|NCT03202264|EG000|Reported Event|TAPERMD|"80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities~TAPER: The intervention is medication reduction. This arm is comprised of:~Medication reconciliation~Identification of patient priorities for care~Identification of medications that are potentially appropriate for discontinuation/dose reduction~Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce~Identification of medications for trial of discontinuation/dose reduction (shared decision making)~Pause of medication and clinical monitoring"
11313696|NCT03202472|BG000|Baseline|Diagnostic (Radiofrequency-guided Localization)|"Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.~Implanted Medical Device: Radiofrequency tag~Mammography: Undergo mammogram for image-guided placement of radiofrequency tag~Questionnaire Administration: Ancillary studies~Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization~Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag"
11313697|NCT03202472|FG000|Participant Flow|Diagnostic (Radiofrequency-guided Localization)|"Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.~Implanted Medical Device: Radiofrequency tag~Mammography: Undergo mammogram for image-guided placement of radiofrequency tag~Questionnaire Administration: Ancillary studies~Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization~Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag"
11313698|NCT03202472|OG000|Outcome|Diagnostic (Radiofrequency-guided Localization)|"Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.~Implanted Medical Device: Radiofrequency tag~Mammography: Undergo mammogram for image-guided placement of radiofrequency tag~Questionnaire Administration: Ancillary studies~Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization~Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag"
11313699|NCT03202472|EG000|Reported Event|Diagnostic (Radiofrequency-guided Localization)|"Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.~Implanted Medical Device: Radiofrequency tag~Mammography: Undergo mammogram for image-guided placement of radiofrequency tag~Questionnaire Administration: Ancillary studies~Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization~Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag"
11313700|NCT03202511|BG000|Baseline|All Study Participants|"All participants received control and/or treatment phase~The control phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) on day 1 (2 tablets) followed by 300/200 mg (1 tablet) doses on days 2 and 3.~The treatment phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (2 tablets) along with a 2 gram oral probenecid (PRO) dose (4 tablets, 500 mg each) on day 1."
11313701|NCT03202511|FG000|Participant Flow|Treatment TDF/FTC+PRO Dose First, Then Control TDF/FTC|Participants received the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1, 2-week washout, then the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3.
11313702|NCT03202511|FG001|Participant Flow|Control TDF/FTC First, Then Treatment TDF/FTC+PRO Dose|Participants received the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3, 2-week washout, then the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1.
11313703|NCT03202511|OG000|Outcome|Treatment Phase|The treatment phase will consist of subjects taking 600/400 mg oral TDF/FTC along with a 2 gram oral PRO dose on day 1.
11313704|NCT03202511|OG001|Outcome|Control Phase|The control phase will consist of subjects taking 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg TDF/FTC on days 2 and 3.
11313705|NCT03202511|EG000|Reported Event|Control Phase|The control phase consisted of subjects taking 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg TDF/FTC on days 2 and 3.
11313706|NCT03202511|EG001|Reported Event|Treatment Phase|The treatment phase consisted of subjects taking 600/400 mg oral TDF/FTC followed by 2 gram oral PRO on day 1.
11313707|NCT03202550|BG000|Baseline|Placebo Arm|"Two oral placebo pills (microcrystalline cellulose capsules)~Placebo Comparator: Placebo oral pills"
11313708|NCT03202550|BG001|Baseline|Active Drug Arm: Lorazepam and Oxycodone|"1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)~Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam"
11313709|NCT03202550|BG002|Baseline|Total|Total of all reporting groups
11313710|NCT03202550|FG000|Participant Flow|Placebo Arm|"Two oral placebo pills (microcrystalline cellulose capsules)~Placebo Comparator: Placebo oral pills"
11313711|NCT03202550|FG001|Participant Flow|Active Drug Arm: Lorazepam and Oxycodone|"1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)~Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam"
11313712|NCT03202550|OG000|Outcome|Placebo Arm|"Two oral placebo pills (microcrystalline cellulose capsules)~Placebo Comparator: Placebo oral pills"
11313713|NCT03202550|OG001|Outcome|Active Drug Arm: Lorazepam and Oxycodone|"1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)~Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam"
11313714|NCT03202550|EG000|Reported Event|Placebo Arm|"Two oral placebo pills (microcrystalline cellulose capsules)~Placebo Comparator: Placebo oral pills"
11313715|NCT03202550|EG001|Reported Event|Active Drug Arm: Lorazepam and Oxycodone|"1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)~Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam"
11094924|NCT01555151|OG001|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
11094925|NCT01555151|OG002|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
11094926|NCT01555151|OG003|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
11094927|NCT01555151|EG000|Reported Event|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
11094928|NCT01555151|EG001|Reported Event|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
11094929|NCT01555151|EG002|Reported Event|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
11094930|NCT01555151|EG003|Reported Event|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
11094931|NCT01555151|EG004|Reported Event|Total|Total
11094932|NCT01555164|BG000|Baseline|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094933|NCT01555164|BG001|Baseline|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094934|NCT01555164|BG002|Baseline|Total|Total of all reporting groups
11094935|NCT01555164|FG000|Participant Flow|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094936|NCT01555164|FG001|Participant Flow|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094937|NCT01555164|OG000|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094938|NCT01555164|OG001|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094939|NCT01555164|EG000|Reported Event|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
11217773|NCT02316470|FG000|Participant Flow|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 1 injection of 0.75 mL (milliliters) VLA84 w/o Alum and 1 injection of 0.75 mL Placebo Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
11217774|NCT02316470|FG001|Participant Flow|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217775|NCT02316470|FG002|Participant Flow|VLA84 200 mcg w/ Alum|"VLA84 200 mcg w/ (with) Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217776|NCT02316470|FG003|Participant Flow|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28~Placebo: phosphate buffered saline (PBS) solution"
11313716|NCT03203291|BG000|Baseline|TPAD Treatment|"All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.~TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb."
11313717|NCT03203291|FG000|Participant Flow|TPAD Treatment|"All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.~TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb."
11313718|NCT03203291|OG000|Outcome|TPAD Treatment|"All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.~TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb."
11313719|NCT03203291|EG000|Reported Event|TPAD Treatment|"All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.~TPAD (Tethered Pelvic Assist Device): Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb."
11313720|NCT03203447|BG000|Baseline|Active|"Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313721|NCT03203447|BG001|Baseline|Control|"Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure~suprachoroidal sham: sham suprachoroidal procedure~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313722|NCT03203447|BG002|Baseline|Total|Total of all reporting groups
11313723|NCT03203447|FG000|Participant Flow|Active|"Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313724|NCT03203447|FG001|Participant Flow|Control|"Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure~suprachoroidal sham: sham suprachoroidal procedure~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313725|NCT03203447|OG000|Outcome|Active|"Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313726|NCT03203447|OG001|Outcome|Control|"Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure~suprachoroidal sham: sham suprachoroidal procedure~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313727|NCT03203447|EG000|Reported Event|Active|"Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection~suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313728|NCT03203447|EG001|Reported Event|Control|"Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure~suprachoroidal sham: sham suprachoroidal procedure~Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin"
11313729|NCT03203564|BG000|Baseline|200 mg/m2 of Modufolin®|8 subjects were treated with 200 mg/m2 of Modufolin® as an intravenous bolus injection.
11313730|NCT03203564|BG001|Baseline|350 mg/m2 of Modufolin®|8 subjects were treated with 350 mg/m2 of Modufolin® as an intravenous bolus injection.
11313731|NCT03203564|BG002|Baseline|500 mg/m2 of Modufolin®|8 subjects were treated with 500 mg/m2 of Modufolin® as an intravenous bolus injection.
11313732|NCT03203564|BG003|Baseline|Placebo|9 subjects were treated with placebo as an intravenous bolus injection.
11313733|NCT03203564|BG004|Baseline|Total|Total of all reporting groups
11313734|NCT03203564|FG000|Participant Flow|200 mg/m2 of Modufolin®|8 subjects were treated with 200 mg/m2 of Modufolin® as an intravenous bolus injection.
11313735|NCT03203564|FG001|Participant Flow|350 mg/m2 of Modufolin®|8 subjects were treated with 350 mg/m2 of Modufolin® as an intravenous bolus injection.
11313736|NCT03203564|FG002|Participant Flow|500 mg/m2 of Modufolin®|8 subjects were treated with 500 mg/m2 of Modufolin® as an intravenous bolus injection.
11313737|NCT03203564|FG003|Participant Flow|Placebo|9 subjects were treated with placebo as an intravenous bolus injection.
11313738|NCT03203564|OG000|Outcome|200 mg/m2 of Modufolin®|8 subjects were treated with 200 mg/m2 of Modufolin® as an intravenous bolus injection.
11313739|NCT03203564|OG001|Outcome|350 mg/m2 of Modufolin®|8 subjects were treated with 350 mg/m2 of Modufolin® as an intravenous bolus injection.
11313740|NCT03203564|OG002|Outcome|500 mg/m2 of Modufolin®|8 subjects were treated with 500 mg/m2 of Modufolin® as an intravenous bolus injection.
11313741|NCT03203564|OG003|Outcome|Placebo|9 subjects were treated with placebo as an intravenous bolus injection.
11313742|NCT03203564|EG000|Reported Event|200 mg/m2 of Modufolin®|8 subjects were treated with 200 mg/m2 of Modufolin® as an intravenous bolus injection.
11313743|NCT03203564|EG001|Reported Event|350 mg/m2 of Modufolin®|8 subjects were treated with 350 mg/m2 of Modufolin® as an intravenous bolus injection.
11313744|NCT03203564|EG002|Reported Event|500 mg/m2 of Modufolin®|8 subjects were treated with 500 mg/m2 of Modufolin® as an intravenous bolus injection.
11313745|NCT03203564|EG003|Reported Event|Placebo|9 subjects were treated with placebo as an intravenous bolus injection.
11313746|NCT03203681|BG000|Baseline|Natesto|"Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.~Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day."
11313747|NCT03203681|FG000|Participant Flow|Natesto|"Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.~Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day."
11313748|NCT03203681|OG000|Outcome|Natesto|"Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.~Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day."
11313749|NCT03203681|EG000|Reported Event|Natesto|"Participants in this group will receive Natesto for a 24 consecutive weeks treatment course.~Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day."
11313750|NCT03204279|BG000|Baseline|Netupitant 1.33 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 1.33 mg/kg up to a maximum of 100 mg (for patients < 3 months of age the netupitant dose will be 0.8 mg/kg) administered with single oral dose of 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313751|NCT03204279|BG001|Baseline|Netupitant 4 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 4 mg/kg up to a maximum of 300 mg (for patients < 3 months of age the netupitant dose will be 2.4 mg/kg) administered with single oral dose 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313752|NCT03204279|BG002|Baseline|Total|Total of all reporting groups
11313753|NCT03204279|FG000|Participant Flow|Netupitant 1.33 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 1.33 mg/kg up to a maximum of 100 mg (for patients < 3 months of age the netupitant dose will be 0.8 mg/kg) administered with single oral dose of 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313754|NCT03204279|FG001|Participant Flow|Netupitant 4 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 4 mg/kg up to a maximum of 300 mg (for patients < 3 months of age the netupitant dose will be 2.4 mg/kg) administered with single oral dose 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313755|NCT03204279|OG000|Outcome|Netupitant 1.33 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 1.33 mg/kg up to a maximum of 100 mg (for patients < 3 months of age the netupitant dose will be 0.8 mg/kg) administered with single oral dose of 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313756|NCT03204279|OG001|Outcome|Netupitant 4 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 4 mg/kg up to a maximum of 300 mg (for patients < 3 months of age the netupitant dose will be 2.4 mg/kg) administered with single oral dose 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313757|NCT03204279|OG000|Outcome|Netupitant 1.33 mg/kg Plus Palonosetron or Netupitant 4 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 1.33 mg/kg up to a maximum of 100 mg (for patients < 3 months of age the netupitant dose will be 0.8 mg/kg) administered with single oral dose of 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Or Single oral dose of Netupitant 4 mg/kg up to a maximum of 300 mg (for patients < 3 months of age the netupitant dose will be 2.4 mg/kg) administered with single oral dose 20 μg/kg palonosetron up to a maximum of 1.5 mg."
11313758|NCT03204279|EG000|Reported Event|Netupitant 1.33 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 1.33 mg/kg up to a maximum of 100 mg (for patients < 3 months of age the netupitant dose will be 0.8 mg/kg) administered with single oral dose of 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313759|NCT03204279|EG001|Reported Event|Netupitant 4 mg/kg Plus Palonosetron|"Single oral dose of Netupitant 4 mg/kg up to a maximum of 300 mg (for patients < 3 months of age the netupitant dose will be 2.4 mg/kg) administered with single oral dose 20 μg/kg palonosetron up to a maximum of 1.5 mg.~Netupitant: Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg~Palonosetron: Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg"
11313760|NCT03204526|BG000|Baseline|Low Frequency Stimulation (LFS)|"Low-frequency deep brain stimulation of the subthalamic nucleus~deep brain stimulation"
11313761|NCT03204526|FG000|Participant Flow|Low Frequency Stimulation (LFS)|"Low-frequency deep brain stimulation of the subthalamic nucleus~deep brain stimulation"
11313762|NCT03204526|OG000|Outcome|Low Frequency Stimulation (LFS)|"Low-frequency deep brain stimulation of the subthalamic nucleus~deep brain stimulation"
11313763|NCT03204526|EG000|Reported Event|Low Frequency Stimulation (LFS)|"Low-frequency deep brain stimulation of the subthalamic nucleus~deep brain stimulation"
10827171|NCT00108069|BG000|Baseline|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827172|NCT00108069|BG001|Baseline|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827173|NCT00108069|BG002|Baseline|Total|Total of all reporting groups
10827174|NCT00108069|FG000|Participant Flow|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827175|NCT00108069|FG001|Participant Flow|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827176|NCT00108069|OG000|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827177|NCT00108069|OG001|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827178|NCT00108069|OG000|Outcome|Grade 1|Mild adverse event
10827179|NCT00108069|OG001|Outcome|Grade 2|Moderate adverse event
10827180|NCT00108069|OG002|Outcome|Grade 3|Severe adverse event
10827181|NCT00108069|OG003|Outcome|Grade 4|Life-threatening or disabling adverse event
10827182|NCT00108069|OG004|Outcome|Grade 5|Death related to adverse event
11335889|NCT03558230|OG001|Outcome|No Vibration|"The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Placebo (for vibration): No vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
10827183|NCT00108069|OG005|Outcome|Total|Total number of participants.
10827184|NCT00108069|EG000|Reported Event|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827185|NCT00108069|EG001|Reported Event|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
10827186|NCT00108082|BG000|Baseline|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
10827187|NCT00108082|BG001|Baseline|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827188|NCT00108082|BG002|Baseline|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827189|NCT00108082|BG003|Baseline|Total|Total of all reporting groups
10827190|NCT00108082|FG000|Participant Flow|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
10827191|NCT00108082|FG001|Participant Flow|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827192|NCT00108082|FG002|Participant Flow|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827193|NCT00108082|OG000|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
10827194|NCT00108082|OG001|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827195|NCT00108082|OG002|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827196|NCT00108082|EG000|Reported Event|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
10827197|NCT00108082|EG001|Reported Event|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
10827198|NCT00108082|EG002|Reported Event|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
11313764|NCT03204942|BG000|Baseline|PRF on DRG|Patients received Pulsed Radiofrequency (PRF)on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.2 active cycles per second of 20 milliseconds each , with a voltage output 40-60-V ,impedance between 150-400 Ohms at all levels using Fluroscopic guidance. RF was performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an AP direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. The location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V . injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle.
11313765|NCT03204942|BG001|Baseline|TRF on DRG|"Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waves was different as previously described"
11313766|NCT03204942|BG002|Baseline|Control Group|"The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).~Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described"
11313767|NCT03204942|BG003|Baseline|Total|Total of all reporting groups
11313768|NCT03204942|FG000|Participant Flow|PRF on DRG|"Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).~PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st"
11313769|NCT03204942|FG001|Participant Flow|TRF on DRG|"Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waves will be different as previously described"
11313770|NCT03204942|FG002|Participant Flow|Control Group|"The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).~Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described"
11313771|NCT03204942|OG000|Outcome|PRF on DRG|"Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).~PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st"
11313772|NCT03204942|OG001|Outcome|TRF on DRG|"Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waves will be different as previously described"
11313773|NCT03204942|OG002|Outcome|Control Group|"The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).~Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described"
11313774|NCT03204942|OG000|Outcome|PRF on DRG|"Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG).~A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle."
10827199|NCT00108160|BG000|Baseline|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
10827200|NCT00108160|BG001|Baseline|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
10827201|NCT00108160|BG002|Baseline|Total|Total of all reporting groups
11313775|NCT03204942|OG001|Outcome|TRF on DRG|"Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waves was different as previously described"
11313776|NCT03204942|OG002|Outcome|Control Group|"The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).~Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described"
11313777|NCT03204942|OG001|Outcome|TRF on DRG|"Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waveswas be different as previously described"
11313778|NCT03204942|OG001|Outcome|TRF on DRG|"Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waveswas different as previously described"
11313779|NCT03204942|EG000|Reported Event|PRF on DRG|"Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG).~A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle."
11313780|NCT03204942|EG001|Reported Event|TRF on DRG|"Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .~TRF on DRG: Similar to the group of  PRF on DRG, but the types of the waves was different as previously described"
11313781|NCT03204942|EG002|Reported Event|Control Group|"The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).~Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described"
11313782|NCT03204981|BG000|Baseline|Intramural Needle Ablation|"Intramural Needle Ablation: The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.~Ablation: standard ablation"
11313783|NCT03204981|FG000|Participant Flow|Intramural Needle Ablation|"Intramural Needle Ablation: The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.~Ablation: standard ablation"
11313784|NCT03204981|OG000|Outcome|Participants With VT|Participants with Ventricular Tachycardia (VT)
11313785|NCT03204981|OG001|Outcome|Participants With PVCs|Participants with Premature Ventricular Contractions (PVCS)
11313786|NCT03204981|OG000|Outcome|Intramural Needle Ablation|"Intramural Needle Ablation: The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.~Ablation: standard ablation"
11313787|NCT03204981|EG000|Reported Event|Intramural Needle Ablation|"Intramural Needle Ablation: The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.~Ablation: standard ablation"
11313788|NCT03205046|BG000|Baseline|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous|Acalabrutinib daily + Vistusertib daily over the 28-day cycle
11313789|NCT03205046|BG001|Baseline|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent|Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
11313790|NCT03205046|BG002|Baseline|Total|Total of all reporting groups
11313791|NCT03205046|FG000|Participant Flow|Acalabrutinib 100 mg BID Plus Vistusertib BID Continuous|Acalabrutinib daily + Vistusertib daily over the 28-day cycle
10827202|NCT00108160|FG000|Participant Flow|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
11313792|NCT03205046|FG001|Participant Flow|Acalabrutinib 100 mg BID Plus Vistusertib BID Intermittent|Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
11313793|NCT03205046|OG000|Outcome|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous|Acalabrutinib daily + Vistusertib daily over the 28-day cycle
11313794|NCT03205046|OG001|Outcome|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent|Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
11313795|NCT03205046|EG000|Reported Event|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous|Acalabrutinib daily + Vistusertib daily over the 28-day cycle
11313796|NCT03205046|EG001|Reported Event|Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent|Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
11313797|NCT03205150|BG000|Baseline|Placebo|LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313798|NCT03205150|BG001|Baseline|LIK066 30 mg|Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313799|NCT03205150|BG002|Baseline|LIK066 150 mg|Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313800|NCT03205150|BG003|Baseline|Total|Total of all reporting groups
11313801|NCT03205150|FG000|Participant Flow|LIK066 30 mg|Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313802|NCT03205150|FG001|Participant Flow|LIK066 150 mg|Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313803|NCT03205150|FG002|Participant Flow|Placebo|LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313804|NCT03205150|OG000|Outcome|LIK066 30 mg|Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313805|NCT03205150|OG001|Outcome|LIK066 150 mg|Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313806|NCT03205150|OG002|Outcome|Placebo|LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313807|NCT03205150|EG000|Reported Event|LIK066 30 mg|Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313808|NCT03205150|EG001|Reported Event|LIK066 150 mg|Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313809|NCT03205150|EG002|Reported Event|Placebo|LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
11313810|NCT03205150|EG003|Reported Event|All Patients|All Patients
11313811|NCT03205488|BG000|Baseline|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
11313812|NCT03205488|BG001|Baseline|Nilotinib 150|Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
10827203|NCT00108160|FG001|Participant Flow|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
11313813|NCT03205488|BG002|Baseline|Nilotinib 300|Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
11313814|NCT03205488|BG003|Baseline|Total|Total of all reporting groups
11313815|NCT03205488|FG000|Participant Flow|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
11313816|NCT03205488|FG001|Participant Flow|Nilotinib 150|Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
11313817|NCT03205488|FG002|Participant Flow|Nilotinib 300|Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
11313818|NCT03205488|OG000|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months
11313819|NCT03205488|OG001|Outcome|Nilotinib 150 mg|Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
10827204|NCT00108160|OG000|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
11313820|NCT03205488|OG002|Outcome|Nilotinib 300 mg|Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
11313821|NCT03205488|OG000|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
11313822|NCT03205488|OG001|Outcome|Nilotinib 150|Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
11313823|NCT03205488|OG002|Outcome|Nilotinib 300|Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
11313824|NCT03205488|OG000|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice per day over the course of 6 months.
11313825|NCT03205488|EG000|Reported Event|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
11313826|NCT03205488|EG001|Reported Event|Nilotinib 150|Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo once per day over the course of 6 months.
11313827|NCT03205488|EG002|Reported Event|Nilotinib 300|Patients were administered 2 capsules of 150 mg Nilotinib once per day over the course of 6 months.
11313828|NCT03205566|BG000|Baseline|Raltegravir, Then Raltegravir Plus Lamivudine|"Raltegravir 400mg tablet, taken twice a day for 7days.~Washout period 28 days~Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days."
11313829|NCT03205566|BG001|Baseline|Raltegravir Lamivudine, Then Raltegravir|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Washout period 28 days~Raltegravir 400Mg Tab: bd for 7 days"
11313830|NCT03205566|BG002|Baseline|Total|Total of all reporting groups
11313831|NCT03205566|FG000|Participant Flow|Raltegravir, Then Raltegravir/Lamivudine|"Raltegravir 400mg tablet, taken twice a day for 7days.~Washout minimum of 28 days~Raltegravir 400mg plus lamivudine 150mg taken twice a day for 7 days"
11313832|NCT03205566|FG001|Participant Flow|Raltegravir Lamivudine, Then Raltegravir|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Washout minimum 28 days~Raltegravir 400Mg Tab: bd for 7 days"
11313833|NCT03205566|OG000|Outcome|Raltegravir|"Raltegravir 400mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days"
11313834|NCT03205566|OG001|Outcome|Raltegravir During Combination Treatment|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days~Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days"
11313835|NCT03205566|OG002|Outcome|Lamivudine During Combination Treatment|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days~Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days"
11313836|NCT03205566|OG001|Outcome|Raltegravir Lamivudine|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days~Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days"
11313837|NCT03205566|OG000|Outcome|Arm A Raltegravir|"Raltegravir 400mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days"
11313838|NCT03205566|OG001|Outcome|Arm B Raltegravir Lamivudine|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days~Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days"
11313839|NCT03205566|EG000|Reported Event|Arm A Raltegravir|"Raltegravir 400mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days"
11313840|NCT03205566|EG001|Reported Event|Arm B Raltegravir Lamivudine|"Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.~Raltegravir 400Mg Tab: bd for 7 days~Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days"
11313841|NCT03206749|BG000|Baseline|VX-150|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
11313842|NCT03206749|BG001|Baseline|HB/APAP|Participants received HB 5 mg/APAP 325 mg q6h for 2 days.
11313843|NCT03206749|BG002|Baseline|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
11313844|NCT03206749|BG003|Baseline|Total|Total of all reporting groups
11313845|NCT03206749|FG000|Participant Flow|VX-150|Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
11313846|NCT03206749|FG001|Participant Flow|Hydrocodone Bitartrate/Acetaminophen (HB/APAP)|Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
11313847|NCT03206749|FG002|Participant Flow|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
11313848|NCT03206749|OG000|Outcome|VX-150|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
11313849|NCT03206749|OG001|Outcome|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
11313850|NCT03206749|OG001|Outcome|HB/APAP|Participants received HB 5 mg/APAP 325 mg q6h for 2 days.
11313851|NCT03206749|OG002|Outcome|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
10827205|NCT00108160|OG001|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
11313852|NCT03206749|EG000|Reported Event|VX-150|Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
11313853|NCT03206749|EG001|Reported Event|HB/APAP|Participants received HB 5 mg/APAP 325 mg q6h for 2 days.
11313854|NCT03206749|EG002|Reported Event|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
11313855|NCT03206788|BG000|Baseline|Losartan Group|Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed).
11313856|NCT03206788|BG001|Baseline|Placebo Group|Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.
11313857|NCT03206788|BG002|Baseline|Total|Total of all reporting groups
11313858|NCT03206788|FG000|Participant Flow|Losartan Group|Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed).
11313859|NCT03206788|FG001|Participant Flow|Placebo Group|Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.
11313860|NCT03206788|OG000|Outcome|Losartan Group|Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed).
11313861|NCT03206788|OG001|Outcome|Placebo Group|Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.
11313862|NCT03206788|EG000|Reported Event|Losartan Group|Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed).
11313863|NCT03206788|EG001|Reported Event|Placebo Group|Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.
11313864|NCT03206918|BG000|Baseline|Zanubrutinib|160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
11313865|NCT03206918|FG000|Participant Flow|Zanubrutinib|160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
11313866|NCT03206918|OG000|Outcome|Zanubrutinib|160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
11313867|NCT03206918|OG000|Outcome|Zanubrutinib|160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
11313868|NCT03206918|EG000|Reported Event|Zanubrutinib|160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years
11313869|NCT03206970|BG000|Baseline|Zanubrutinib|Zanubrutinib (160 mg) administered BID until Zanubrutinib (160 milligrams [mg]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
11313870|NCT03206970|FG000|Participant Flow|Zanubrutinib|Zanubrutinib (160 milligrams [mg]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
11313871|NCT03206970|OG000|Outcome|Zanubrutinib|Zanubrutinib (160 mg) administered BID until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
11313872|NCT03206970|EG000|Reported Event|Zanubrutinib|Zanubrutinib (160 mg) administered BID for over 3 years.
11313873|NCT03207022|BG000|Baseline|Lidocaine 2% With Normal Saline|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313874|NCT03207022|BG001|Baseline|Lidocaine 2% With Clonidine|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313875|NCT03207022|BG002|Baseline|Total|Total of all reporting groups
11313876|NCT03207022|FG000|Participant Flow|Lidocaine 2% With Normal Saline|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313877|NCT03207022|FG001|Participant Flow|Lidocaine 2% With Clonidine|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313878|NCT03207022|OG000|Outcome|Lidocaine 2% With Normal Saline|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313879|NCT03207022|OG001|Outcome|Lidocaine 2% With Clonidine|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313880|NCT03207022|EG000|Reported Event|Lidocaine 2% With Normal Saline|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313881|NCT03207022|EG001|Reported Event|Lidocaine 2% With Clonidine|"Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.~axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine"
11313882|NCT03207035|BG000|Baseline|20 ml of Lidocaine 2% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313883|NCT03207035|BG001|Baseline|40 ml 0f Lidocaine 1% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313884|NCT03207035|BG002|Baseline|Total|Total of all reporting groups
11313885|NCT03207035|FG000|Participant Flow|20 ml of Lidocaine 2% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313886|NCT03207035|FG001|Participant Flow|40 ml 0f Lidocaine 1% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313887|NCT03207035|OG000|Outcome|20 ml of Lidocaine 2% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313888|NCT03207035|OG001|Outcome|40 ml 0f Lidocaine 1% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313889|NCT03207035|EG000|Reported Event|20 ml of Lidocaine 2% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313890|NCT03207035|EG001|Reported Event|40 ml 0f Lidocaine 1% With Epinephrine|"Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)~Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine"
11313891|NCT03207074|BG000|Baseline|All Patients|Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife).
11313892|NCT03207074|FG000|Participant Flow|All Patients|Single study arm. All patients who participate in the study will receive a tissue biopsy, one processed with the conventional histology and one processed with the iKnife (Rapid Evaporative Ionisation Mass Spectrometry).
11313893|NCT03207074|OG000|Outcome|All Patients|Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife)
11313894|NCT03207074|EG000|Reported Event|All Patients|Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife).
11313895|NCT03207243|BG000|Baseline|Placebo|Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313896|NCT03207243|BG001|Baseline|GSK3772847|Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313897|NCT03207243|BG002|Baseline|Total|Total of all reporting groups
11313898|NCT03207243|FG000|Participant Flow|Placebo|Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313899|NCT03207243|FG001|Participant Flow|GSK3772847|Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313900|NCT03207243|OG000|Outcome|Placebo|Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313901|NCT03207243|OG001|Outcome|GSK3772847|Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313902|NCT03207243|OG000|Outcome|GSK3772847|Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313903|NCT03207243|EG000|Reported Event|Placebo|Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
11313904|NCT03207243|EG001|Reported Event|GSK3772847|Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief.
10827206|NCT00108160|OG000|Outcome|Mupirocin Ointment [Treatment]|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
10827207|NCT00108160|OG001|Outcome|Polyethylene Glycol Ointment [Placebo]|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
11313905|NCT03207386|BG000|Baseline|Youth VIP|"Youth VIP is a youth-led set of prevention strategies. Youth and their adult mentors are trained in evidence based sexual assault primary prevention strategies at a three day youth summit. The summit is followed by participation in working groups in which youth and their adult mentors will adapt best practices for sexual assault prevention to the Rapid City community and diffuse these strategies through both their own social networks and more formally in work in Rapid City middle and high schools.~Youth VIP: Youth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups."
10827208|NCT00108160|EG000|Reported Event|Mupirocin Ointment|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
10827209|NCT00108160|EG001|Reported Event|Polyethylene Glycol Ointment|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
10827210|NCT00108277|BG000|Baseline|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
10827211|NCT00108277|BG001|Baseline|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
10827212|NCT00108277|BG002|Baseline|Waitlist|"Waitlist~Treatment as usual"
10827213|NCT00108277|BG003|Baseline|Total|Total of all reporting groups
10827214|NCT00108277|FG000|Participant Flow|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
10827215|NCT00108277|FG001|Participant Flow|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
10827216|NCT00108277|FG002|Participant Flow|Waitlist|Waitlist Treatment as Usual
10827217|NCT00108277|OG000|Outcome|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2"
10827218|NCT00108277|OG001|Outcome|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2"
10827219|NCT00108277|OG002|Outcome|Waitlist|Waitlist Treatment as usual
10827220|NCT00108277|EG000|Reported Event|Raise CO2|Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2
10827221|NCT00108277|EG001|Reported Event|Lower CO2|Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2
10827222|NCT00108277|EG002|Reported Event|Waitlist|Treatment as usual
10827223|NCT00108303|BG000|Baseline|Schizophrenia Probands|Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
10827224|NCT00108303|BG001|Baseline|Schizophrenia Relatives|Persons who are first degree relatives of persons in Arm 1
10827225|NCT00108303|BG002|Baseline|Controls|Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
10827226|NCT00108303|BG003|Baseline|Total|Total of all reporting groups
10827227|NCT00108303|FG000|Participant Flow|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
10827228|NCT00108303|FG001|Participant Flow|Schizophrenia Relatives|Subjects who are first degree relatives of subjects in Arm 1.
10827229|NCT00108303|FG002|Participant Flow|Controls|Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
10827230|NCT00108303|OG000|Outcome|Group 1|Subjects who receive genetic study.
10827231|NCT00108303|OG000|Outcome|Schizophrenia Probands|Persons who have schizophrenia as determined by diagnosis
10827232|NCT00108303|OG001|Outcome|Schizophrenia Relatives|Persons who are siblings or children of someone with schizophrenia
10827233|NCT00108303|OG002|Outcome|Controls|Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
10827234|NCT00108303|OG000|Outcome|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia.
10827235|NCT00108303|OG001|Outcome|Schizophrenia Relatives|Persons who are relatives of probands in Group 1.
10827236|NCT00108303|OG002|Outcome|Controls|Persons who are not relatives of persons with schizophrenia and do not have schizophrenia themselves.
10827237|NCT00108303|EG000|Reported Event|Schizophrenia Probands|Schizophrenia probands as diagnosed as having schizophrenia
10827238|NCT00108303|EG001|Reported Event|Schizophrenia Relatives|Schizophrenia relatives who siblings or children of persons with schizophrenia
10827239|NCT00108303|EG002|Reported Event|Controls|Controls who do not have personal or family history of schizophrenia
10827240|NCT00108355|BG000|Baseline|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
10827241|NCT00108355|BG001|Baseline|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
10827242|NCT00108355|BG002|Baseline|Total|Total of all reporting groups
10827243|NCT00108355|FG000|Participant Flow|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
10827244|NCT00108355|FG001|Participant Flow|Vasoconstrictors (Study Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
10827245|NCT00108355|OG000|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
10827246|NCT00108355|OG001|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
10827247|NCT00108355|EG000|Reported Event|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
10827248|NCT00108355|EG001|Reported Event|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
10827249|NCT00108485|BG000|Baseline|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
10827250|NCT00108485|BG001|Baseline|Placebo|Placebo tablets
11313906|NCT03207386|FG000|Participant Flow|Youth VIP|"Youth VIP is a youth-led set of prevention strategies. Youth and their adult mentors are trained in evidence based sexual assault primary prevention strategies at a three day youth summit. The summit is followed by participation in working groups in which youth and their adult mentors will adapt best practices for sexual assault prevention to the Rapid City community and diffuse these strategies through both their own social networks and more formally in work in Rapid City middle and high schools.~Youth VIP: Youth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups.~Participants could be in both the large camp condition and/or the small camp condition, thus numbers do not consistently add up to 2647 across the results reports for the study."
11313907|NCT03207386|OG000|Outcome|Attended Large Camp|Participants attended a large prevention camp.
11313908|NCT03207386|OG001|Outcome|Did Not Attend Large Camp|Participants did not attend a large prevention camp.
11313909|NCT03207386|OG002|Outcome|Attended Small Camp|Participants attended a small prevention camp.
11313910|NCT03207386|OG003|Outcome|Did Not Attend Small Camp|Participants did not attend a small prevention camp.
11313911|NCT03207386|EG000|Reported Event|Youth VIP|"Youth VIP is a youth-led set of prevention strategies. Youth and their adult mentors are trained in evidence based sexual assault primary prevention strategies at a three day youth summit. The summit is followed by participation in working groups in which youth and their adult mentors will adapt best practices for sexual assault prevention to the Rapid City community and diffuse these strategies through both their own social networks and more formally in work in Rapid City middle and high schools.~Youth VIP: Youth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups."
11313912|NCT03207399|BG000|Baseline|Epclusa|"Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.~Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant."
11313913|NCT03207399|FG000|Participant Flow|Epclusa|"Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.~Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant."
11313914|NCT03207399|OG000|Outcome|Epclusa|"Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.~Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant."
11313915|NCT03207399|EG000|Reported Event|Epclusa|"Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.~Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant."
11313916|NCT03207438|BG000|Baseline|Quetiapine XR 50mg|"Quetiapine XR 50mg OD for 6 weeks~Quetiapine 50 MG Extended Release Oral Tablet: OD"
11313917|NCT03207438|BG001|Baseline|Placebo 1|"Placebo OD for 6 weeks~Placebos: Placebo"
11313918|NCT03207438|BG002|Baseline|Quetiapine XR 150-300mg|"Quetiapine XR 150-300mg OD for 6 weeks~Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD"
11313919|NCT03207438|BG003|Baseline|Placebo 2|"Placebo OD for 6 weeks~Placebos: Placebo"
11313920|NCT03207438|BG004|Baseline|Total|Total of all reporting groups
11313921|NCT03207438|FG000|Participant Flow|Quetiapine XR 50mg|"Quetiapine XR 50mg OD for 6 weeks~Quetiapine 50 MG Extended Release Oral Tablet: OD"
11313922|NCT03207438|FG001|Participant Flow|Placebo 1|"Placebo OD for 6 weeks~Placebos: Placebo"
11313923|NCT03207438|FG002|Participant Flow|Quetiapine XR 150-300mg|"Quetiapine XR 150-300mg OD for 6 weeks~Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD"
11313924|NCT03207438|FG003|Participant Flow|Placebo 2|"Placebo OD for 6 weeks~Placebos: Placebo"
11313925|NCT03207438|OG000|Outcome|Quetiapine XR 150-300mg - Melancholic Depression|"Quetiapine XR 150-300mg OD for 6 weeks~Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD"
11313926|NCT03207438|OG001|Outcome|Placebo 2 - Melancholic Depression|"Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)~Placebos: Placebo"
11313927|NCT03207438|OG002|Outcome|Quetiapine XR 150-300mg - Nonmelancholic Depression|"Quetiapine XR 150-300mg OD for 6 weeks~Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD"
11313928|NCT03207438|OG003|Outcome|Placebo 2 - Nonmelancholic Depression|"Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)~Placebos: Placebo"
11313929|NCT03207438|OG000|Outcome|Quetiapine XR 50mg - Insomnia|"Quetiapine XR 50mg OD for 6 weeks~Quetiapine 50 MG Extended Release Oral Tablet: OD"
11313930|NCT03207438|OG001|Outcome|Placebo 1 - Insomnia|"Placebo OD for 6 weeks~Placebos: Placebo"
11313931|NCT03207438|OG002|Outcome|Quetiapine XR 50mg - No Insomnia|"Quetiapine XR 150-300mg OD for 6 weeks~Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD"
11313932|NCT03207438|OG003|Outcome|Placebo 1 - No Insomnia|"Placebo OD for 6 weeks~Placebos: Placebo"
11313933|NCT03207438|OG000|Outcome|Quetiapine XR 50mg|"Quetiapine XR 50mg OD for 6 weeks~Quetiapine 50 MG Extended Release Oral Tablet: OD"
10827251|NCT00108485|BG002|Baseline|Total|Total of all reporting groups
11313934|NCT03207438|OG001|Outcome|Placebo 1|"Placebo OD for 6 weeks~Placebos: Placebo"
11313935|NCT03207438|EG000|Reported Event||Adverse events were not measured in this study, as it was a secondary analysis of efficacy data from four, previously conducted clinical trials (intervention studies). We did not have access to the adverse events data. Please refer to the original trial reports for this information.
11313936|NCT03207750|BG000|Baseline|HRV Porcine Circovirus (PCV)-Free Liquid Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11313937|NCT03207750|BG001|Baseline|HRV Lyophilized Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
11313938|NCT03207750|BG002|Baseline|Total|Total of all reporting groups
11313939|NCT03207750|FG000|Participant Flow|HRV Porcine Circovirus (PCV)-Free Liquid Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11313940|NCT03207750|FG001|Participant Flow|HRV Lyophilized Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
11313941|NCT03207750|OG000|Outcome|HRV Porcine Circovirus (PCV)-Free Liquid Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11313942|NCT03207750|OG001|Outcome|HRV Lyophilized Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
11313943|NCT03207750|EG000|Reported Event|HRV Porcine Circovirus (PCV)-Free Liquid Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
11313944|NCT03207750|EG001|Reported Event|HRV Lyophilized Group|Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
11313945|NCT03207763|BG000|Baseline|Cohort 1|Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313946|NCT03207763|BG001|Baseline|Cohort 2|Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313947|NCT03207763|BG002|Baseline|Total|Total of all reporting groups
11313948|NCT03207763|FG000|Participant Flow|Cohort 1|Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313949|NCT03207763|FG001|Participant Flow|Cohort 2|Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313950|NCT03207763|OG000|Outcome|Cohort 1|Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313951|NCT03207763|OG001|Outcome|Cohort 2|Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313952|NCT03207763|OG000|Outcome|Cohort 1, Patch 1|Participating infants and children receiving Patch 1 of Microneedle Formulation 1
11313953|NCT03207763|OG001|Outcome|Cohort 1, Patches 2 and 3|Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 1
11313954|NCT03207763|OG002|Outcome|Cohort 2, Patch 1|Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
11313955|NCT03207763|OG003|Outcome|Cohort 2, Patches 2 and 3|Participating infants and children receiving Patches 2 and 3 of Microneedle Formulation 2.
11313956|NCT03207763|OG001|Outcome|Cohort 1, Patch 2|Participating infants and children receiving Patch 2 of Microneedle Formulation 1
11313957|NCT03207763|OG002|Outcome|Cohort 1, Patch 3|Participating infants and children receiving Patch 3 of Microneedle Formulation 1
11313958|NCT03207763|OG003|Outcome|Cohort 2, Patch 1|Participating infants and children receiving Patch 1 of Microneedle Formulation 2.
11313959|NCT03207763|OG004|Outcome|Cohort 2, Patch 2|Participating infants and children receiving Patch 2 of Microneedle Formulation 2.
11313960|NCT03207763|OG005|Outcome|Cohort 2, Patch 3|Participating infants and children receiving Patch 3 of Microneedle Formulation 2.
11313961|NCT03207763|EG000|Reported Event|Cohort 1|Participating infants and children receiving Microneedle Formulation 1. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313962|NCT03207763|EG001|Reported Event|Cohort 2|Participating infants and children receiving Microneedle Formulation 2. Children had a microneedle patch initially applied to the skin overlying the shoulder blade. If the first patch was well tolerated without halting criteria having been met, participants could opt to have two additional microneedle patches applied to the upper arm, forearm, wrist and/or thigh.
11313963|NCT03208088|BG000|Baseline|Completed Subjects|All subjects who were administered study article and completed all required study visits.
11313964|NCT03208088|FG000|Participant Flow|Test 3/Test 2/Test 4/Test 1/Control|Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Test 4 in period 3, Test 1 in period 4, Control in period 5.
11313965|NCT03208088|FG001|Participant Flow|Test 3/Test 4/Test 2/Control/Test 1|Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 4 in period 2, Test 2 in period 3, Control in period 4, Test 1 in period 5.
11313966|NCT03208088|FG002|Participant Flow|Test 1/Control/Test 2/Test 4/Test 3|Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, Test 4 in period 4, Test 3 in period 5.
11313967|NCT03208088|FG003|Participant Flow|Test 1/Test 2/Control/Test 3/Test 4|Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Test 2 in period 2, Control in period 3, Test 3 in period 4, Test 4 in period 5.
11313968|NCT03208088|FG004|Participant Flow|Control/Test 1/Test 4/Test 2/Test 3|Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 1 in period 2, Test 4 in period 3, Test 2 in period 4, Test 3 in period 5.
11313969|NCT03208088|FG005|Participant Flow|Control/Test 4/Test 1/Test 3/Test 2|Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 4 in period 2, Test 1 in period 3, Test 3 in period 4, Test 2 in period 5.
11313970|NCT03208088|FG006|Participant Flow|Test 2/Test 3/Test 1/Test 4 /Control|Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 3 in period 2, Test 1 in period 3, Test 4 in period 4, Control in period 5.
11313971|NCT03208088|FG007|Participant Flow|Test 2/Test 1/Test 3/Control/Test 4|Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, Control in period 4, Test 4 in period 5.
11313972|NCT03208088|FG008|Participant Flow|Test 4/Test 3/Control/Test 2/Test 1|Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Test 3 in period 2, Control in period 3, Test 2 in period 4, Test 1 in period 5.
11313973|NCT03208088|FG009|Participant Flow|Test 4/Control/Test 3/Test 1/Test 2|Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Control in period 2, Test 3 in period 3, Test 1 in period 4, Test 2 in period 5.
11313974|NCT03208088|OG000|Outcome|Test 1|Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study.
11313975|NCT03208088|OG001|Outcome|Test 2|Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study.
11313976|NCT03208088|OG002|Outcome|Control|Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
11313977|NCT03208088|OG000|Outcome|Test 3|Subjects that wore the Test 3 lens in either the first, second, third, fourth, or fifth period of the study.
11313978|NCT03208088|OG001|Outcome|Test 4|Subjects that wore the Test 4 lens in either the first, second, third, fourth, or fifth period of the study.
11313979|NCT03208088|EG000|Reported Event|Test 1|Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study.
11313980|NCT03208088|EG001|Reported Event|Test 2|Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study.
11313981|NCT03208088|EG002|Reported Event|Test 3|Subjects that wore the Test 3 lens in either the first, second, third, fourth, or fifth period of the study.
11313982|NCT03208088|EG003|Reported Event|Test 4|Subjects that wore the Test 4 lens in either the first, second, third, fourth, or fifth period of the study.
11313983|NCT03208088|EG004|Reported Event|Control|Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study.
11313984|NCT03208166|BG000|Baseline|Ischemic Conditioning|"Doctormate device is used daily.~Doctormate: Ischemic conditioning device~Usual Care: Standard medical care"
11313985|NCT03208166|BG001|Baseline|Usual Care|"Standard medical care.~Usual Care: Standard medical care"
11313986|NCT03208166|BG002|Baseline|Total|Total of all reporting groups
11313987|NCT03208166|FG000|Participant Flow|Ischemic Conditioning|"Doctormate device is used daily.~Doctormate: Ischemic conditioning device~Usual Care: Standard medical care"
11313988|NCT03208166|FG001|Participant Flow|Usual Care|"Standard medical care.~Usual Care: Standard medical care"
11313989|NCT03208166|OG000|Outcome|Ischemic Conditioning|"Doctormate device is used daily.~Doctormate: Ischemic conditioning device~Usual Care: Standard medical care"
11313990|NCT03208166|OG001|Outcome|Usual Care|"Standard medical care.~Usual Care: Standard medical care"
11313991|NCT03208166|EG000|Reported Event|Ischemic Conditioning|"Doctormate device is used daily.~Doctormate: Ischemic conditioning device~Usual Care: Standard medical care"
11313992|NCT03208166|EG001|Reported Event|Usual Care|"Standard medical care.~Usual Care: Standard medical care"
11313993|NCT03208192|BG000|Baseline|ErbeJet|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11313994|NCT03208192|BG001|Baseline|Misonix|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11313995|NCT03208192|BG002|Baseline|Total|Total of all reporting groups
11313996|NCT03208192|FG000|Participant Flow|ErbeJet|liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
11313997|NCT03208192|FG001|Participant Flow|Misonix|liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
11313998|NCT03208192|OG000|Outcome|ErbeJet|liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
11313999|NCT03208192|OG001|Outcome|Misonix|liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
11314000|NCT03208192|OG000|Outcome|ErbeJet|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11314001|NCT03208192|OG001|Outcome|Misonix|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11314002|NCT03208192|EG000|Reported Event|ErbeJet|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11314003|NCT03208192|EG001|Reported Event|Misonix|"liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)~liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection"
11314004|NCT03208673|BG000|Baseline|Optive® Fusion™ and Optive® Gel Drop|A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
11314005|NCT03208673|FG000|Participant Flow|Optive® Fusion™ and Optive® Gel Drop|A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
11314006|NCT03208673|OG000|Outcome|Optive® Fusion™ and Optive® Gel Drop|A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
11314007|NCT03208673|EG000|Reported Event|Optive® Fusion™ and Optive® Gel Drop|A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
11314008|NCT03208933|BG000|Baseline|Pirfenidone|Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
11314009|NCT03208933|FG000|Participant Flow|Pirfenidone|Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
11314010|NCT03208933|OG000|Outcome|Pirfenidone|Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
11314011|NCT03208933|EG000|Reported Event|Pirfenidone|Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
11314012|NCT03209050|BG000|Baseline|Central Venous Access Placement|"Central venous access placement~Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter"
11314013|NCT03209050|FG000|Participant Flow|Central Venous Access Placement|"Central venous access placement~Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter"
11314014|NCT03209050|OG000|Outcome|Central Venous Access Placement|"Central venous access placement in 26/30 patients~Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 26/30 patients"
11314015|NCT03209050|OG000|Outcome|Central Venous Access Placement|"Central venous access placement in 27/30 patients~Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 27/30 patients"
11314016|NCT03209050|EG000|Reported Event|Central Venous Access Placement|"Central venous access placement~Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter"
11314017|NCT03209362|BG000|Baseline|SI-613|The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
11314018|NCT03209362|BG001|Baseline|Placebo|The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
11314019|NCT03209362|BG002|Baseline|Total|Total of all reporting groups
11314020|NCT03209362|FG000|Participant Flow|SI-613|The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
11314021|NCT03209362|FG001|Participant Flow|Placebo|The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
11314022|NCT03209362|OG000|Outcome|SI-613|The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
11314023|NCT03209362|OG001|Outcome|Placebo|The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
11314024|NCT03209362|EG000|Reported Event|SI-613|The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
11094940|NCT01555164|EG001|Reported Event|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
11094941|NCT01555463|BG000|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
11094942|NCT01555463|BG001|Baseline|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
11094943|NCT01555463|BG002|Baseline|Total|Total of all reporting groups
11094944|NCT01555463|FG000|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
11094945|NCT01555463|FG001|Participant Flow|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
11094946|NCT01555463|OG000|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
11094947|NCT01555463|OG001|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
11094948|NCT01555463|EG000|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
11094949|NCT01555463|EG001|Reported Event|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
11094955|NCT01555567|BG000|Baseline|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
11094956|NCT01555567|BG001|Baseline|Standard of Care|This group will undergo standard ACL rehabilitation
11094957|NCT01555567|BG002|Baseline|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094958|NCT01555567|BG003|Baseline|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094959|NCT01555567|BG004|Baseline|Total|Total of all reporting groups
11094960|NCT01555567|FG000|Participant Flow|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo neuromuscular electrical stimulation (NMES) following anterior cruciate ligament (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
11094961|NCT01555567|FG001|Participant Flow|Standard of Care|This group will undergo standard ACL rehabilitation
11094962|NCT01555567|FG002|Participant Flow|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11217777|NCT02316470|OG000|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
11314025|NCT03209362|EG001|Reported Event|Placebo|The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
11094963|NCT01555567|FG003|Participant Flow|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11217778|NCT02316470|OG001|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217779|NCT02316470|OG002|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217780|NCT02316470|OG003|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
11217781|NCT02316470|EG000|Reported Event|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
11217782|NCT02316470|EG001|Reported Event|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217783|NCT02316470|EG002|Reported Event|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
11217784|NCT02316470|EG003|Reported Event|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
11217785|NCT02316548|BG000|Baseline|No Radiation Therapy|Patients do not receive radiation therapy (RT).
11217786|NCT02316548|BG001|Baseline|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
11217787|NCT02316548|BG002|Baseline|Total|Total of all reporting groups
11217788|NCT02316548|FG000|Participant Flow|No Radiation Therapy|Patients do not receive radiation therapy (RT).
11217789|NCT02316548|FG001|Participant Flow|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
11217790|NCT02316548|OG000|Outcome|No Radiation Therapy|Patients do not receive radiation therapy (RT).
11217791|NCT02316548|OG001|Outcome|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
11217792|NCT02316548|EG000|Reported Event|No Radiation Therapy|Patients do not receive radiation therapy (RT).
11217793|NCT02316548|EG001|Reported Event|Intensity-modulated Radiation Therapy (IMRT)|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
11217794|NCT02316613|BG000|Baseline|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11217795|NCT02316613|FG000|Participant Flow|All Participants|Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11217796|NCT02316613|OG000|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11217797|NCT02316613|OG000|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment.
11217798|NCT02316613|OG000|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
11217799|NCT02316613|OG001|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
11217800|NCT02316613|OG000|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11217801|NCT02316613|OG000|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received MabThera treatment over the first study induction period was reported.
11217802|NCT02316613|OG001|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.
11314026|NCT03209492|BG000|Baseline|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.
11314027|NCT03209492|FG000|Participant Flow|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.
11314028|NCT03209492|OG000|Outcome|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.
11314029|NCT03209492|EG000|Reported Event|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.
11314030|NCT03209505|BG000|Baseline|Contact Lenses|Forty (40) eyes of twenty subjects were examined. One eye of each subject was assigned either the low coefficient of friction lens and the other eye received the high coefficient of friction lens. Lens/eye assignment occurred per the study randomization schedule.
11314031|NCT03209505|FG000|Participant Flow|Eye 1: Low Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys.~Acuvue Oasys: FDA approved contact lens, fit for daily wear"
11314032|NCT03209505|FG001|Participant Flow|Eye 2: High Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night & Day Aqua~Air Optix Night & Day Aqua: FDA approved contact lens, fit for daily wear"
11314033|NCT03209505|OG000|Outcome|Eye 1: Low Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys.~Acuvue Oasys: FDA approved contact lens, fit for daily wear"
11314034|NCT03209505|OG001|Outcome|Eye 2: High Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night & Day Aqua~Air Optix Night & Day Aqua: FDA approved contact lens, fit for daily wear"
11314035|NCT03209505|EG000|Reported Event|Eye 1: Low Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys.~Acuvue Oasys: FDA approved contact lens, fit for daily wear"
11314036|NCT03209505|EG001|Reported Event|Eye 2: High Coefficient of Friction|"Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night & Day Aqua~Air Optix Night & Day Aqua: FDA approved contact lens, fit for daily wear"
11314037|NCT03209518|BG000|Baseline|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
11314038|NCT03209518|FG000|Participant Flow|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
11314039|NCT03209518|OG000|Outcome|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
11314040|NCT03209518|EG000|Reported Event|Leuprorelin Acetate 22.5 mg|Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
11314041|NCT03209570|BG000|Baseline|TENA Identifi With Sensor Wear Data|"All individuals in this arm will receive care planning using TENA Identifi sensor wear data~Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning."
11314042|NCT03209570|BG001|Baseline|TENA Identifi Without Sensor Wear Data|"All individuals in this arm will receive care planning without using TENA Identifi sensor wear data~Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning."
11314043|NCT03209570|BG002|Baseline|Total|Total of all reporting groups
11314044|NCT03209570|FG000|Participant Flow|TENA Identifi With Sensor Wear Data|"All individuals in this arm will receive care planning using TENA Identifi sensor wear data~Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning."
11314045|NCT03209570|FG001|Participant Flow|TENA Identifi Without Sensor Wear Data|"All individuals in this arm will receive care planning without using TENA Identifi sensor wear data~Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning."
11314046|NCT03209570|OG000|Outcome|TENA Identifi With Sensor Wear Data|"All individuals in this arm will receive care planning using TENA Identifi sensor wear data~Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning."
11314047|NCT03209570|OG001|Outcome|TENA Identifi Without Sensor Wear Data|"All individuals in this arm will receive care planning without using TENA Identifi sensor wear data~Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning."
11314048|NCT03209570|EG000|Reported Event|TENA Identifi With Sensor Wear Data|"All individuals in this arm will receive care planning using TENA Identifi sensor wear data~Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning."
11314049|NCT03209570|EG001|Reported Event|TENA Identifi Without Sensor Wear Data|"All individuals in this arm will receive care planning without using TENA Identifi sensor wear data~Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning."
11094964|NCT01555567|OG000|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
11094965|NCT01555567|OG001|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
11094966|NCT01555567|OG002|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094967|NCT01555567|OG003|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094968|NCT01555567|EG000|Reported Event|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
11094969|NCT01555567|EG001|Reported Event|Standard of Care|This group will undergo standard ACL rehabilitation
11094970|NCT01555567|EG002|Reported Event|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094971|NCT01555567|EG003|Reported Event|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
11094972|NCT01555671|BG000|Baseline|Study Group|0.5 ml meperidine injection intravenously injected in randomly selected patients
11094973|NCT01555671|BG001|Baseline|Plasebo Group|0.5 ml saline solution injection intravenously injected in randomly selected patients
11094974|NCT01555671|BG002|Baseline|Total|Total of all reporting groups
11094975|NCT01555671|FG000|Participant Flow|Study Group|Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine,0.5ml (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .
11094976|NCT01555671|FG001|Participant Flow|Control Group|Bag B (placebo group), containing 0.5ml of normal saline solution.
11094977|NCT01555671|OG000|Outcome|Meperidine Administration Group|"Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .Providers and patients were blinded to the contents of the bags until the conclusion of the study. Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution.~Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients"
11094978|NCT01555671|OG001|Outcome|Plasebo Group|"Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution.~Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients"
11094979|NCT01555671|OG000|Outcome|Meperidine Administration Group|Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients
11094980|NCT01555671|OG001|Outcome|Plasebo Group|Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients
11094981|NCT01555671|EG000|Reported Event|Study Group|
11094982|NCT01555671|EG001|Reported Event|Control Group|
11094983|NCT01555697|BG000|Baseline|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11094984|NCT01555697|BG001|Baseline|Healthy Subjects: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11094985|NCT01555697|BG002|Baseline|Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11314050|NCT03209882|BG000|Baseline|One TILS, One Sham, and Then Five TILS Interventions|Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
11314051|NCT03209882|BG001|Baseline|One Sham, Then Six TILS Interventions|Participants first received a sham session, followed by six weekly TILS sessions.
11314052|NCT03209882|BG002|Baseline|Total|Total of all reporting groups
11314053|NCT03209882|FG000|Participant Flow|One TILS, One Sham, and Then Five TILS Interventions|Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
11314054|NCT03209882|FG001|Participant Flow|One Sham, Then Six TILS Interventions|Participants first received a sham session, followed by six weekly TILS sessions.
11314055|NCT03209882|OG000|Outcome|One TILS, One Sham, and Then Five TILS Interventions|Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
11314056|NCT03209882|OG001|Outcome|One Sham, Then Six TILS Interventions|Participants first received a sham session, followed by six weekly TILS sessions.
11314057|NCT03209882|OG000|Outcome|One TILS, One Sham, and Then Five TILS Interventions|"Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.~TILS: Continuous-wave laser of a specific wavelength (1064 nm) was administered to the participants' right forehead for 8 minutes. The laser power was 3.4 Watts.~sham: The sham session consisted of administering the same laser to the participants' right forehead for totally 8 minutes. However, the laser power was turned to be 0 Watts."
11314058|NCT03209882|OG001|Outcome|One Sham, Then Six TILS Interventions|"Participants first received a sham session, followed by six weekly TILS sessions.~TILS: Continuous-wave laser of a specific wavelength (1064 nm) was administered to the participants' right forehead for 8 minutes. The laser power was 3.4 Watts.~sham: The sham session consisted of administering the same laser to the participants' right forehead for totally 8 minutes. However, the laser power was turned to be 0 Watts."
11314059|NCT03209882|EG000|Reported Event|One TILS, One Sham, and Then Five TILS Interventions|Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
11314060|NCT03209882|EG001|Reported Event|One Sham, Then Six TILS Interventions|Participants first received a sham session, followed by six weekly TILS sessions.
11314061|NCT03209973|BG000|Baseline|Tislelizumab|Tislelizumab 200 mg administered IV Q3W until PD, unacceptable toxicity, death, or study withdrawal by the participant.
11314062|NCT03209973|FG000|Participant Flow|Tislelizumab|Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) until progressive disease (PD), unacceptable toxicity, death, or study withdrawal by the participant.
11314063|NCT03209973|OG000|Outcome|Tislelizumab|Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
11314064|NCT03209973|OG000|Outcome|Tislelizumab|Tislelizumab 200 mg administered IV Q3W until PD, unacceptable toxicity, death, or study withdrawal by the participant.
11314065|NCT03209973|OG000|Outcome|Tislelizumab|Tislelizumab 200 mg administered IV Q3W until PD unacceptable toxicity, death, or study withdrawal by the participant.
11314066|NCT03209973|EG000|Reported Event|Tislelizumab|Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
11314067|NCT03210155|BG000|Baseline|Active Comparator|"About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).~Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level)."
11314068|NCT03210155|BG001|Baseline|Sham Comparator|"The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.~Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks."
11314069|NCT03210155|BG002|Baseline|Total|Total of all reporting groups
11314070|NCT03210155|FG000|Participant Flow|Active Comparator|"About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).~Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level)."
11314071|NCT03210155|FG001|Participant Flow|Sham Comparator|"The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.~Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks."
11314072|NCT03210155|OG000|Outcome|Active Comparator|"About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).~Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level)."
11314073|NCT03210155|OG001|Outcome|Sham Comparator|"The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.~Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks."
11314074|NCT03210155|EG000|Reported Event|Active Comparator|"About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).~Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level)."
11314075|NCT03210155|EG001|Reported Event|Sham Comparator|"The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.~Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks."
11314076|NCT03210220|BG000|Baseline|Pecs Group|Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .
11314077|NCT03210220|BG001|Baseline|Control Group|There is no block.
11314078|NCT03210220|BG002|Baseline|Total|Total of all reporting groups
11314079|NCT03210220|FG000|Participant Flow|Pecs Group|Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .
11314080|NCT03210220|FG001|Participant Flow|Control Group|There is no block.
11314081|NCT03210220|OG000|Outcome|Pecs Group|Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .
11314082|NCT03210220|OG001|Outcome|Control Group|There is no block.
11314083|NCT03210220|EG000|Reported Event|Pecs Group|Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .
11314084|NCT03210220|EG001|Reported Event|Control Group|There is no block.
11314085|NCT03210259|BG000|Baseline|Switching Arm (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period (Period 1) of 14 weeks and were then randomized to the switching arm for the randomized treatment period (Period 2) of 34 weeks followed by 10 weeks of safety follow-up.~During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg BI 695501 at Week 14 and Week 16 (2 injections), followed by 40 mg US-licensed Humira at Week 18 and Week 20 (2 injections), and subsequently 40 mg BI 695501 every other week from Week 22 to Week 48 (14 injections). Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab or BI 695501 per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the switching arm were included in this group."
11314086|NCT03210259|BG001|Baseline|Continuous Humira (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period of 14 weeks (Period 1) and were then randomized to the continuous Humira arm for the randomized treatment period of 34 weeks (Period 2) followed by 10 weeks of safety follow-up. During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg US-licensed Humira every other week from Week 14 to Week 48 (18 injections).Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the continuous Humira arm were included in this group."
11314087|NCT03210259|BG002|Baseline|Total|Total of all reporting groups
11314088|NCT03210259|FG000|Participant Flow|Not Randomized|"Patients received US-licensed Humira during the run-in period. A loading dose of 80 milligrams (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. At the beginning of Week 14, patients who achieved at least a 50 percent reduction in Psoriasis Area and Severity Index (PASI50) response were randomized in a 1:1 ratio to either a continuous arm receiving 40mg of US-licensed Humira every other week until week 48 or in a switching arm separated in 3 periods.~Patients who participated in the run-in period but not being randomized after run-in period were included in this group."
11314089|NCT03210259|FG001|Participant Flow|Switching Arm (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period (Period 1) of 14 weeks and were then randomized to the switching arm for the randomized treatment period (Period 2) of 34 weeks followed by 10 weeks of safety follow-up.~During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg BI 695501 at Week 14 and Week 16 (2 injections), followed by 40 mg US-licensed Humira at Week 18 and Week 20 (2 injections), and subsequently 40 mg BI 695501 every other week from Week 22 to Week 48 (14 injections). Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab or BI 695501 per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the switching arm were included in this group."
11314090|NCT03210259|FG002|Participant Flow|Continuous Humira (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period of 14 weeks (Period 1) and were then randomized to the continuous Humira arm for the randomized treatment period of 34 weeks (Period 2) followed by 10 weeks of safety follow-up. During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg US-licensed Humira every other week from Week 14 to Week 48 (18 injections).Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the continuous Humira arm were included in this group."
11314091|NCT03210259|OG000|Outcome|Switching Arm (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period (Period 1) of 14 weeks and were then randomized to the switching arm for the randomized treatment period (Period 2) of 34 weeks followed by 10 weeks of safety follow-up.~During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg BI 695501 at Week 14 and Week 16 (2 injections), followed by 40 mg US-licensed Humira at Week 18 and Week 20 (2 injections), and subsequently 40 mg BI 695501 every other week from Week 22 to Week 48 (14 injections). Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab or BI 695501 per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the switching arm were included in this group."
11314092|NCT03210259|OG001|Outcome|Continuous Humira (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period of 14 weeks (Period 1) and were then randomized to the continuous Humira arm for the randomized treatment period of 34 weeks (Period 2) followed by 10 weeks of safety follow-up. During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg US-licensed Humira every other week from Week 14 to Week 48 (18 injections).Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the continuous Humira arm were included in this group."
11314093|NCT03210259|EG000|Reported Event|Humira Containing All RTS Subjects (Run-In Period)|"All patients received US-licensed Humira during the run-in period of 14 weeks (Period 1). Patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab per 0.8 milliliter (mL).~All patients in the run-in period were in this group including those who were randomised and who did not being randomised after the run-in period."
11314094|NCT03210259|EG001|Reported Event|Switching Arm (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period (Period 1) of 14 weeks and were then randomized to the switching arm for the randomized treatment period (Period 2) of 34 weeks followed by 10 weeks of safety follow-up.~During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg BI 695501 at Week 14 and Week 16 (2 injections), followed by 40 mg US-licensed Humira at Week 18 and Week 20 (2 injections), and subsequently 40 mg BI 695501 every other week from Week 22 to Week 48 (14 injections). Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab or BI 695501 per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the switching arm were included in this group."
11314095|NCT03210259|EG002|Reported Event|Continuous Humira (Post-Randomization Period)|"Patients initially received US-licensed Humira during the run-in period of 14 weeks (Period 1) and were then randomized to the continuous Humira arm for the randomized treatment period of 34 weeks (Period 2) followed by 10 weeks of safety follow-up. During Period 1, patients were administered with a loading dose of 80 milligram (mg) US-licensed Humira on Day 1 (Week 1), followed by 40 mg every other week from Week 2 to Week 12. During Period 2, patients received 40 mg US-licensed Humira every other week from Week 14 to Week 48 (18 injections).Trial medication were administered by subcutaneous (s.c.) injection providing in single-use pre-filled syringes (PFS) containing 40 mg of adalimumab per 0.8 milliliter (mL).~Patients who went through the run-in period and being randomised into the continuous Humira arm were included in this group."
11314096|NCT03210337|BG000|Baseline|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11314097|NCT03210337|BG001|Baseline|Vehicle|"Vehicle~A-101 Topical Solution: A-101 Topical Solution"
11314098|NCT03210337|BG002|Baseline|Total|Total of all reporting groups
11314099|NCT03210337|FG000|Participant Flow|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11314100|NCT03210337|FG001|Participant Flow|Vehicle|"Vehicle~A-101 Topical Solution: A-101 Topical Solution"
11314101|NCT03210337|OG000|Outcome|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11314102|NCT03210337|OG001|Outcome|Vehicle|"Vehicle~A-101 Topical Solution: A-101 Topical Solution"
11314103|NCT03210337|EG000|Reported Event|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11314104|NCT03210337|EG001|Reported Event|Vehicle|"Vehicle~A-101 Topical Solution: A-101 Topical Solution"
11314105|NCT03210376|BG000|Baseline|Deep Neuromuscular Blockade (NMB) + Sugammadex|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
11314106|NCT03210376|BG001|Baseline|Moderate Neuromuscular Blockade (NMB) + Neostigmine|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
11314107|NCT03210376|BG002|Baseline|Total|Total of all reporting groups
11314108|NCT03210376|FG000|Participant Flow|Deep Neuromuscular Blockade (NMB) + Sugammadex|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
11314109|NCT03210376|FG001|Participant Flow|Moderate Neuromuscular Blockade (NMB) + Neostigmine|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
11314110|NCT03210376|OG000|Outcome|Deep Neuromuscular Blockade (NMB) + Sugammadex|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
11314111|NCT03210376|OG001|Outcome|Moderate Neuromuscular Blockade (NMB) + Neostigmine|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
11314112|NCT03210376|EG000|Reported Event|Deep Neuromuscular Blockade (NMB) + Sugammadex|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
11314113|NCT03210376|EG001|Reported Event|Moderate Neuromuscular Blockade (NMB) + Neostigmine|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the MNMB group, the Rocuronium infusion rate will be adjusted to maintain 1-2 TOF responses and will be reversed with Neostigmine 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute, at the end of surgery.
11314114|NCT03210519|BG000|Baseline|Eleutherococcus Senticosus|Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
11314115|NCT03210519|BG001|Baseline|Placebo|Fructus Ziziphi Jujube concentrated juice15ml/vial
11314116|NCT03210519|BG002|Baseline|Total|Total of all reporting groups
11314117|NCT03210519|FG000|Participant Flow|Eleutherococcus Senticosus|Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Acanthopanax senticosus-mono formula 30mg/vial and Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
11314118|NCT03210519|FG001|Participant Flow|Placebo|Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
11314119|NCT03210519|OG000|Outcome|Eleutherococcus Senticosus|Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
11314120|NCT03210519|OG001|Outcome|Placebo|Fructus Ziziphi Jujube concentrated juice15ml/vial
11314121|NCT03210519|EG000|Reported Event|Eleutherococcus Senticosus|Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
11314122|NCT03210519|EG001|Reported Event|Placebo|Fructus Ziziphi Jujube concentrated juice15ml/vial
11314123|NCT03210701|BG000|Baseline|Study Participants|Patients requesting a rapid HIV test at a community pharmacy study site.
11314124|NCT03210701|FG000|Participant Flow|Study Participants|Patients requesting a rapid HIV test at a community pharmacy study site.
11314125|NCT03210701|OG000|Outcome|Study Participants|Patients requesting a rapid HIV test at a community pharmacy study site.
11314126|NCT03210701|EG000|Reported Event|Study Participants|Patients requesting a rapid HIV test at a community pharmacy study site.
11314127|NCT03210961|BG000|Baseline|Placebo (PBO) SAD (3 mg, 10 mg)|During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
11314128|NCT03210961|BG001|Baseline|PBO SAD Followed by (->) PBO QD MAD|During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
11314129|NCT03210961|BG002|Baseline|PBO QD MAD Japanese Cohort (JP)|During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
11314130|NCT03210961|BG003|Baseline|PBO BID|During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
11314131|NCT03210961|BG004|Baseline|PF-06826647 3 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
11314132|NCT03210961|BG005|Baseline|PF-06826647 10 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
11314133|NCT03210961|BG006|Baseline|PF-06826647 30 mg SAD -> 30 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314134|NCT03210961|BG007|Baseline|PF-06826647 100 mg SAD -> 100 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314135|NCT03210961|BG008|Baseline|PF-06826647 400 mg SAD -> 400 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
11314136|NCT03210961|BG009|Baseline|PF-06826647 1600 mg SAD -> 1200 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314137|NCT03210961|BG010|Baseline|PF-06826647 200 mg BID|During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
11314138|NCT03210961|BG011|Baseline|PF-06826647 400 mg QD MAD JP|During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314139|NCT03210961|BG012|Baseline|PBO QD Psoriasis Cohort (PSO)|In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314140|NCT03210961|BG013|Baseline|PF-06826647 400 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314141|NCT03210961|BG014|Baseline|PF-06826647 100 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314142|NCT03210961|BG015|Baseline|Total|Total of all reporting groups
11314143|NCT03210961|FG000|Participant Flow|Placebo (PBO) SAD (3 Milligrams [mg], 10 mg)|During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
11314144|NCT03210961|FG001|Participant Flow|PBO SAD Followed by (->) PBO QD MAD|During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
11314145|NCT03210961|FG002|Participant Flow|PBO QD MAD Japanese Cohort (JP)|During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
11314146|NCT03210961|FG003|Participant Flow|PBO Twice Daily (BID)|During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
11314147|NCT03210961|FG004|Participant Flow|PF-06826647 3 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
11314148|NCT03210961|FG005|Participant Flow|PF-06826647 10 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
11314149|NCT03210961|FG006|Participant Flow|PF-06826647 30 mg SAD -> 30 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314150|NCT03210961|FG007|Participant Flow|PF-06826647 100 mg SAD -> 100 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314151|NCT03210961|FG008|Participant Flow|PF-06826647 400 mg SAD -> 400 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
11314152|NCT03210961|FG009|Participant Flow|PF-06826647 1600 mg SAD -> 1200 mg QD MAD|During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
11314153|NCT03210961|FG010|Participant Flow|PF-06826647 200 mg BID|During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
11314154|NCT03210961|FG011|Participant Flow|PF-06826647 400 mg QD MAD JP|During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314155|NCT03210961|FG012|Participant Flow|PBO QD Psoriasis Cohort (PSO)|In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314156|NCT03210961|FG013|Participant Flow|PF-06826647 400 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314157|NCT03210961|FG014|Participant Flow|PF-06826647 100 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
11314158|NCT03210961|OG000|Outcome|PBO SAD|During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
11314159|NCT03210961|OG001|Outcome|PF-06826647 3 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
11314160|NCT03210961|OG002|Outcome|PF-06826647 10 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
11314161|NCT03210961|OG003|Outcome|PF-06826647 30 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
11314162|NCT03210961|OG004|Outcome|PF-06826647 100 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
11314163|NCT03210961|OG005|Outcome|PF-06826647 400 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
11314164|NCT03210961|OG006|Outcome|PF-06826647 1600 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
11314165|NCT03210961|OG000|Outcome|PBO QD MAD (JP PBO Included)|This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
11314166|NCT03210961|OG001|Outcome|PBO BID|During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
11314167|NCT03210961|OG002|Outcome|PF-06826647 30 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
11314168|NCT03210961|OG003|Outcome|PF-06826647 100 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
11314169|NCT03210961|OG004|Outcome|PF-06826647 400 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
11314170|NCT03210961|OG005|Outcome|PF-06826647 1200 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
11314171|NCT03210961|OG006|Outcome|PF-06826647 200 mg BID|During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
11314172|NCT03210961|OG007|Outcome|PF-06826647 400 mg QD MAD JP|During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314173|NCT03210961|OG000|Outcome|PBO QD PSO|In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
11314174|NCT03210961|OG001|Outcome|PF-06826647 400 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314175|NCT03210961|OG002|Outcome|PF-06826647 100 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314176|NCT03210961|OG000|Outcome|PBO QD MAD|This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
11314177|NCT03210961|OG000|Outcome|PF-06826647 3 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
11314178|NCT03210961|OG001|Outcome|PF-06826647 10 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
11314179|NCT03210961|OG002|Outcome|PF-06826647 30 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
11314180|NCT03210961|OG003|Outcome|PF-06826647 100 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
11314181|NCT03210961|OG004|Outcome|PF-06826647 400 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
11314182|NCT03210961|OG005|Outcome|PF-06826647 1600 mg SAD|During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
11314183|NCT03210961|OG000|Outcome|PF-06826647 30 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
11314184|NCT03210961|OG001|Outcome|PF-06826647 100 mg QD MAD|In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
11314185|NCT03210961|OG002|Outcome|PF-06826647 200 mg BID MAD|During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
11314186|NCT03210961|OG003|Outcome|PF-06826647 400 QD MAD|In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
11314187|NCT03210961|OG004|Outcome|PF-06826647 400 mg QD MAD JP|During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314188|NCT03210961|OG000|Outcome|PF-06826647 100 mg QD PSO|In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314189|NCT03210961|EG000|Reported Event|Placebo SAD|During the SAD period (Period 1), the healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg cohort SD cohort in fasted state. SAD period duration was 8 days. (Those placebo participants matching 30, 100, 400, or 1600 SD cohort later continued into MAD period and received the placebo matching 30, 100, 400, or 1200 mg QD cohort, respectively.)
10827252|NCT00108485|FG000|Participant Flow|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
10827253|NCT00108485|FG001|Participant Flow|Placebo|Placebo tablets
11314190|NCT03210961|EG001|Reported Event|Placebo QD MAD (JP Placebo Included)|This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants (they had completed the SAD period) received placebo matching PF-06826647 30, 100, 400, or 1200 mg QD cohort while the Japanese participants (they did not take part in SAD period) received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal. MAD period duration was 28 days.
11314191|NCT03210961|EG002|Reported Event|Placebo BID|Edit During the MAD period (Period 2), the healthy participants received placebo matching PF-06826647 200 mg BID cohort for 10 days with standard meal. MAD period duration was 28 days.
11314192|NCT03210961|EG003|Reported Event|PF-06826647 3 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
11314193|NCT03210961|EG004|Reported Event|PF-06826647 10 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
11314194|NCT03210961|EG005|Reported Event|PF-06826647 30 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 30 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 30 mg QD in MAD period.)
11314195|NCT03210961|EG006|Reported Event|PF-06826647 30 mg QD MAD|During the MAD period (Period 2), the healthy participants who had taken PF-06826647 30 mg SD received PF-06826647 30 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314196|NCT03210961|EG007|Reported Event|PF-06826647 100 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 100 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 100 mg QD in MAD period.)
11314197|NCT03210961|EG008|Reported Event|PF-06826647 100 mg QD MAD|During the MAD period (Period 2), the healthy participants who had taken PF-06826647 100 mg SD received PF-06826647 100 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314198|NCT03210961|EG009|Reported Event|PF-06826647 400 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 400 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 400 mg QD in MAD period.)
11314199|NCT03210961|EG010|Reported Event|PF-06826647 400 mg QD MAD|During the MAD period (Period 2), the healthy participants who had taken PF-06826647 400 mg SD received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314200|NCT03210961|EG011|Reported Event|PF-06826647 1600 mg SAD|During the SAD period (Period 1), the healthy participants received PF-06826647 1600 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 1200 mg QD in MAD period.)
11314201|NCT03210961|EG012|Reported Event|PF-06826647 1200 mg QD MAD|During the MAD period (Period 2), the healthy participants who had taken PF-06826647 1600 mg SD received PF-06826647 1200 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314202|NCT03210961|EG013|Reported Event|PF-06826647 200 mg BID|During the MAD period (Period 2), the healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
11314203|NCT03210961|EG014|Reported Event|PF-06826647 400 mg QD MAD JP|During the MAD period (Period 2), the Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
11314204|NCT03210961|EG015|Reported Event|Placebo QD PSO|In the psoriasis (PSO) cohorts, the psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314205|NCT03210961|EG016|Reported Event|PF-06826647 400 mg QD PSO|In this psoriasis cohort, the psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314206|NCT03210961|EG017|Reported Event|PF-06826647 100 mg QD PSO|In this psoriasis cohort, the psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
11314207|NCT03211117|BG000|Baseline|Cohort B (Pembrolizumab, Chemoradiation)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.>~> Docetaxel: Given IV>~> Doxorubicin Hydrochloride: Given IV>~> Intensity-Modulated Radiation Therapy: Undergo IMRT>~> Laboratory Biomarker Analysis: Correlative studies>~> Pembrolizumab: Given IV"
11314208|NCT03211117|FG000|Participant Flow|Cohort A (Pembrolizumab, Surgery, Chemoradiation)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients undergo surgery. Within 42 days of surgery, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery"
11314209|NCT03211117|FG001|Participant Flow|Cohort B (Pembrolizumab, Chemoradiation)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV"
11314210|NCT03211117|OG000|Outcome|Cohort B (Pembrolizumab, Chemoradiation)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.>~> Docetaxel: Given IV>~> Doxorubicin Hydrochloride: Given IV>~> Intensity-Modulated Radiation Therapy: Undergo IMRT>~> Laboratory Biomarker Analysis: Correlative studies>~> Pembrolizumab: Given IV"
11314211|NCT03211117|OG000|Outcome|Cohort B (Pembrolizumab, Chemoradiation)|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.~>~> Docetaxel: Given IV~>~> Doxorubicin Hydrochloride: Given IV~>~> Intensity-Modulated Radiation Therapy: Undergo IMRT~>~> Laboratory Biomarker Analysis: Correlative studies~>~> Pembrolizumab: Given IV"
11314212|NCT03211117|EG000|Reported Event|Cohort B (Pembrolizumab, Chemoradiation)|Pembrolizumab: Given IV
11314213|NCT03211117|EG001|Reported Event|Cohort A|"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients undergo surgery. Within 42 days of surgery, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.~Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery"
11314214|NCT03211156|BG000|Baseline|Placebo|"Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49~Placebo: Placebo"
11314215|NCT03211156|BG001|Baseline|Amoxicillin|"Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic"
11314216|NCT03211156|BG002|Baseline|Total|Total of all reporting groups
10827254|NCT00108485|OG000|Outcome|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
10827255|NCT00108485|OG001|Outcome|Placebo|Placebo tablets
11314217|NCT03211156|FG000|Participant Flow|Placebo|"Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49~Placebo: Placebo"
11314218|NCT03211156|FG001|Participant Flow|Amoxicillin|"Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic"
11314219|NCT03211156|OG000|Outcome|Placebo|"Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49~Placebo: Placebo"
11314220|NCT03211156|OG001|Outcome|Amoxicillin|"Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic"
11314221|NCT03211156|EG000|Reported Event|Placebo|"Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49~Placebo: Placebo"
11314222|NCT03211156|EG001|Reported Event|Amoxicillin|"Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48~Amoxicillin: Amoxicillin is an aminopenicillin antibiotic"
11314223|NCT03211234|BG000|Baseline|Sham|"Sham and Lucentis~Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis."
11314224|NCT03211234|BG001|Baseline|2.0 mg DE-122|"Low Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis."
11314225|NCT03211234|BG002|Baseline|4.0 mg DE-122|"High Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis."
11314226|NCT03211234|BG003|Baseline|Total|Total of all reporting groups
11314227|NCT03211234|FG000|Participant Flow|Sham|"Sham and Lucentis~Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis."
11314228|NCT03211234|FG001|Participant Flow|2.0 mg DE-122|"Low Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis."
11314229|NCT03211234|FG002|Participant Flow|4.0 mg DE-122|"High Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis."
11314230|NCT03211234|OG000|Outcome|Sham|"Sham and Lucentis~Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis."
11314231|NCT03211234|OG001|Outcome|2.0 mg DE-122|"Low Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis."
11314232|NCT03211234|OG002|Outcome|4.0 mg DE-122|"High Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis."
11314233|NCT03211234|EG000|Reported Event|Sham|"Sham and Lucentis~Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis."
11314234|NCT03211234|EG001|Reported Event|2.0 mg DE-122|"Low Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis."
11314235|NCT03211234|EG002|Reported Event|4.0 mg DE-122|"High Dose DE-122 and Lucentis~DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis."
11314236|NCT03212261|BG000|Baseline|3RP-Lymphoma|Individuals who initiated and participated in any 3RP-lymphoma session
11314237|NCT03212261|FG000|Participant Flow|3RP-Lymphoma|"-An adapted version of the 3RP (3RP-Lymphoma) for lymphoma survivors recently completing cancer treatment. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. It will be delivered in weekly sessions over the course of approximately 8 weeks.~3RP-Lymphoma: An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma."
11314238|NCT03212261|OG000|Outcome|3RP-Lymphoma|Individuals who initiated and participated in any 3RP-lymphoma session
11314239|NCT03212261|OG000|Outcome|3RP-Lymphoma|Individuals who initiated and participated in any 3RP-lymphoma session and completed the 1 month follow up survey
11314240|NCT03212261|EG000|Reported Event|3RP-Lymphoma|"-An adapted version of the 3RP (3RP-Lymphoma) for lymphoma survivors recently completing cancer treatment. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. It will be delivered in weekly sessions over the course of approximately 8 weeks.~3RP-Lymphoma: An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma."
11314241|NCT03212326|BG000|Baseline|Definity|"Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.~Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia."
11314242|NCT03212326|FG000|Participant Flow|Definity|"Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.~Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia."
11314243|NCT03212326|OG000|Outcome|Definity|"Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.~Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia."
11314244|NCT03212326|EG000|Reported Event|Definity|"Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.~Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia."
11314245|NCT03212365|BG000|Baseline|Fixed Dose|"Participants will receive 40 mg enoxaparin twice daily~Fixed dose: Participants will receive 40 mg enoxaparin twice daily"
11314246|NCT03212365|BG001|Baseline|Variable Dose|"Participants will receive 0.5mg/kg enoxaparin twice daily~Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily"
11314247|NCT03212365|BG002|Baseline|Total|Total of all reporting groups
11314248|NCT03212365|FG000|Participant Flow|Fixed Dose|"Participants will receive 40 mg enoxaparin twice daily~Fixed dose: Participants will receive 40 mg enoxaparin twice daily"
11314249|NCT03212365|FG001|Participant Flow|Variable Dose|"Participants will receive 0.5mg/kg enoxaparin twice daily~Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily"
11314250|NCT03212365|OG000|Outcome|Fixed Dose|"Participants will receive 40 mg enoxaparin twice daily~Fixed dose: Participants will receive 40 mg enoxaparin twice daily"
11314251|NCT03212365|OG001|Outcome|Variable Dose|"Participants will receive 0.5mg/kg enoxaparin twice daily~Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily"
11314252|NCT03212365|EG000|Reported Event|Fixed Dose|"Participants will receive 40 mg enoxaparin twice daily~Fixed dose: Participants will receive 40 mg enoxaparin twice daily"
11314253|NCT03212365|EG001|Reported Event|Variable Dose|"Participants will receive 0.5mg/kg enoxaparin twice daily~Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily"
11314254|NCT03212521|BG000|Baseline|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
11314255|NCT03212521|FG000|Participant Flow|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
11314256|NCT03212521|OG000|Outcome|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
11314257|NCT03212521|EG000|Reported Event|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
11314258|NCT03212638|BG000|Baseline|Part A:All Participants|All participants who received study drug during Part A.
11314259|NCT03212638|BG001|Baseline|Part B: All Participants|All participants who received study drug during Part B.
11314260|NCT03212638|BG002|Baseline|Total|Total of all reporting groups
11314261|NCT03212638|FG000|Participant Flow|Part A: Sequence ABC|"A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)~B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)~C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)~With a 72 hour washout between doses"
11314262|NCT03212638|FG001|Participant Flow|Part A: Sequence BCA|"B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)~C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)~A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)~With a 72 hour washout between doses"
11314263|NCT03212638|FG002|Participant Flow|Part A: Sequence CAB|"C: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)~A: 4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)~B: 4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)~With a 72 hour washout between doses"
11314264|NCT03212638|FG003|Participant Flow|Part B: Sequence DE|"D: 4 mg baricitinib suspension test formulation (TF) administered when fasting (TF fasting).~E:4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)~With a 72 hour washout between doses"
11314265|NCT03212638|FG004|Participant Flow|Part B:Sequence ED|"E: 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)~D: 4 mg baricitinib suspension test formulation (TF) administered when fasting. (TF fasting)~With a 72 hour washout between doses"
11314266|NCT03212638|OG000|Outcome|Part A: Baricitinib T1|4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
11314267|NCT03212638|OG001|Outcome|Part A: Baricitinib T2|4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
11314268|NCT03212638|OG002|Outcome|Part A: Baricitinib R|4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
11314269|NCT03212638|OG003|Outcome|Part B: Baricitinib TF Fasted|4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
11314270|NCT03212638|OG004|Outcome|Part B: Baricitinib TF Fed|4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
11314271|NCT03212638|EG000|Reported Event|Part A: Baricitinib T1|4 mg baricitinib suspension administered orally (PO) without water following a 10 hour fast. (Baricitinib T1).
11314272|NCT03212638|EG001|Reported Event|Part A: Baricitinib T2|4 mg baricitinib suspension administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2).
11314273|NCT03212638|EG002|Reported Event|Part A: Baricitinib R|4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
11094986|NCT01555697|BG003|Baseline|Healthy Subjects: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094987|NCT01555697|BG004|Baseline|Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
11094988|NCT01555697|BG005|Baseline|Healthy Subjects: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
11094989|NCT01555697|BG006|Baseline|Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094990|NCT01555697|BG007|Baseline|Healthy Subjects: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094991|NCT01555697|BG008|Baseline|Total|Total of all reporting groups
11094992|NCT01555697|FG000|Participant Flow|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11094993|NCT01555697|FG001|Participant Flow|Healthy Subjects: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11094994|NCT01555697|FG002|Participant Flow|Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094995|NCT01555697|FG003|Participant Flow|Healthy Subjects: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094996|NCT01555697|FG004|Participant Flow|Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
11094997|NCT01555697|FG005|Participant Flow|Healthy Subjects: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
11094998|NCT01555697|FG006|Participant Flow|Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11094999|NCT01555697|FG007|Participant Flow|Healthy Subjects: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11095000|NCT01555697|OG000|Outcome|Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11095001|NCT01555697|OG001|Outcome|Healthy Subjects: Placebo 1st, Then 10 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory.
11095002|NCT01555697|OG002|Outcome|Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11095003|NCT01555697|OG003|Outcome|Healthy Subjects: 10 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11314274|NCT03212638|EG003|Reported Event|Part B: Baricitinib TF Fasted|4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast (TF fasting).
11314275|NCT03212638|EG004|Reported Event|Part B: Baricitinib TF Fed|4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed).
11314276|NCT03212690|BG000|Baseline|Mechanically Ventilated Participants|Participants were enrolled following being mechanically ventilated and had their first echocardiogram (TTE and TOE) within 48 hours of mechanical ventilation. Participants were assessed every 24 hours for a further two days with daily echocardiography to monitor right and left ventricular function. Participants received standard of care including fluid, use of vasopressor drugs and renal support.
11314277|NCT03212690|FG000|Participant Flow|Mechanically Ventilated Participants|Participants were enrolled following being mechanically ventilated and had their first echocardiogram (transthoracic echocardiogram [TTE] and transoesophageal echocardiogram [TOE]) within 48 hours of mechanical ventilation. Participants were assessed every 24 hours for a further two days with daily echocardiography to monitor right and left ventricular function. Participants received standard of care including fluid, use of vasopressor drugs and renal support.
11314278|NCT03212690|OG000|Outcome|Mechanically Ventilated Participants|Participants were enrolled following being mechanically ventilated and had their first echocardiogram (TTE and TOE) within 48 hours of mechanical ventilation. Participants were assessed every 24 hours for a further two days with daily echocardiography to monitor right and left ventricular function. Participants received standard of care including fluid, use of vasopressor drugs and renal support.
11314279|NCT03212690|EG000|Reported Event|Mechanically Ventilated Participants|Participants were enrolled following being mechanically ventilated and had their first echocardiogram (TTE and TOE) within 48 hours of mechanical ventilation. Participants were assessed every 24 hours for a further two days with daily echocardiography to monitor right and left ventricular function. Participants received standard of care including fluid, use of vasopressor drugs and renal support.
11314280|NCT03213210|BG000|Baseline|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant."
11314281|NCT03213210|FG000|Participant Flow|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant."
11314282|NCT03213210|OG000|Outcome|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant."
11314283|NCT03213210|EG000|Reported Event|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant."
11314284|NCT03213366|BG000|Baseline|E-PrEP- Peer-Led Intervention About PrEP|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group."
11314285|NCT03213366|BG001|Baseline|BxNow- General Health Control Arm|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words."
11314286|NCT03213366|BG002|Baseline|Total|Total of all reporting groups
11314287|NCT03213366|FG000|Participant Flow|E-PrEP- Peer-Led Intervention About PrEP|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group."
11335890|NCT03558230|EG000|Reported Event|Vibration|"The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Vibration: Vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
11314288|NCT03213366|FG001|Participant Flow|BxNow-General Health Control Arm:|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words."
11314289|NCT03213366|OG000|Outcome|E-PrEP- Peer-Led Intervention About PrEP|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group."
11314290|NCT03213366|OG001|Outcome|BxNow- General Health Control Arm|"We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.~Content: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words."
11314291|NCT03213366|EG000|Reported Event|E-PrEP- Peer-Led Intervention About PrEP|"8 Peer Leaders (PLs) will be randomly assigned to the E-PrEP arm. Each of the PLs will recruit at least 15 participants into a private social media group on one of several social media platforms. PLs will then deliver a behavioral intervention over a 6 week period, posting information and engaging participants in a discussion about PrEP, PrEP access, and other related health issues. All contents will be formatted to be both mobile device accessible.~Intervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily."
11314292|NCT03213366|EG001|Reported Event|BxNow - General Health Campaign|"BxNow is an attention-matched control. Eight of the 16 PLs will be randomly assigned to the BxNow arm. The BxNow campaign will be a 6-week long social media intervention about general health wellness topics chosen and administered by the PLs assigned into this arm. Similarly to the intervention group, PLs in the BxNow arm will create private social media groups and recruit participants into these private groups. General health information in the BxNow arm will be posted with the same frequency as in the intervention arm.~BxNow - General Health Campaign: BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial."
11314293|NCT03213405|BG000|Baseline|Conventional BCG Full Dose|"Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.~Conventional BCG full dose: 2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection."
11314294|NCT03213405|BG001|Baseline|rBCG-N-hRSV 1/100 Dose|"Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/100: 5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314295|NCT03213405|BG002|Baseline|rBCG-N-hRSV 1/10 Dose|"Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/10: 5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314296|NCT03213405|BG003|Baseline|rBCG-N-hRSV Full Dose|"Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV full dose: 1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314297|NCT03213405|BG004|Baseline|Total|Total of all reporting groups
11314298|NCT03213405|FG000|Participant Flow|Conventional BCG Full Dose|"Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.~Conventional BCG full dose: 2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection."
11314299|NCT03213405|FG001|Participant Flow|rBCG-N-hRSV 1/100 Dose|"Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/100: 5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314300|NCT03213405|FG002|Participant Flow|rBCG-N-hRSV 1/10 Dose|"Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/10: 5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
10827256|NCT00108485|EG000|Reported Event|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
10827257|NCT00108485|EG001|Reported Event|Placebo|Placebo tablets
10827258|NCT00108524|BG000|Baseline|Arm 1|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
10827259|NCT00108524|BG001|Baseline|Arm 2|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
10827260|NCT00108524|BG002|Baseline|Total|Total of all reporting groups
10827261|NCT00108524|FG000|Participant Flow|Low Carbohydrate Ketogenic Diet|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
10827262|NCT00108524|FG001|Participant Flow|Low-Fat Diet Plus Orlistat|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
10827263|NCT00108524|OG000|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
10827264|NCT00108524|OG001|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
10827265|NCT00108524|EG000|Reported Event|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
10827266|NCT00108524|EG001|Reported Event|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
10827267|NCT00108550|BG000|Baseline|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
10827268|NCT00108550|BG001|Baseline|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
10827269|NCT00108550|BG002|Baseline|Total|Total of all reporting groups
10827270|NCT00108550|FG000|Participant Flow|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
10827271|NCT00108550|FG001|Participant Flow|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
10827272|NCT00108550|OG000|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
10827273|NCT00108550|OG001|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
10827274|NCT00108550|EG000|Reported Event|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
10827275|NCT00108550|EG001|Reported Event|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
10827276|NCT00108628|BG000|Baseline|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
10827277|NCT00108628|BG001|Baseline|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
10827278|NCT00108628|BG002|Baseline|Total|Total of all reporting groups
10827279|NCT00108628|FG000|Participant Flow|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
11095004|NCT01555697|OG004|Outcome|Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
10827280|NCT00108628|FG001|Participant Flow|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
10827281|NCT00108628|OG000|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
10827282|NCT00108628|OG001|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
10827283|NCT00108628|EG000|Reported Event|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
10827284|NCT00108628|EG001|Reported Event|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
10827285|NCT00108732|BG000|Baseline|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
10827286|NCT00108732|FG000|Participant Flow|Vaccinia/Fowlpox/GM-CSF|"There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.~Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
10827287|NCT00108732|OG000|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
10827288|NCT00108732|EG000|Reported Event|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
10827289|NCT00108745|BG000|Baseline|Arm I (Paclitaxel Poliglumex)|"Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel Poliglumex: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827290|NCT00108745|BG001|Baseline|Arm II (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827291|NCT00108745|BG002|Baseline|Arm III (Observation)|"Patients receive no further anticancer treatment until evidence of disease progression.~Clinical Observation: Undergo observation~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
10827292|NCT00108745|BG003|Baseline|Total|Total of all reporting groups
11095005|NCT01555697|OG005|Outcome|Healthy Subjects: Placebo 1st, Then 20 mg Memantine|This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory.
11095006|NCT01555697|OG006|Outcome|Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11095007|NCT01555697|OG007|Outcome|Healthy Subjects: 20 mg Memantine 1st, Then Placebo|This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory.
11095008|NCT01555697|EG000|Reported Event|Memantine|Memantine: Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11095009|NCT01555697|EG001|Reported Event|Placebo|Placebo: Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
11095010|NCT01555762|BG000|Baseline|Bevacizumab|Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
11095011|NCT01555762|FG000|Participant Flow|Bevacizumab|Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
11095012|NCT01555762|OG000|Outcome|Bevacizumab|Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
11095013|NCT01555762|EG000|Reported Event|Bevacizumab|Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
11095014|NCT01555931|BG000|Baseline|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095015|NCT01555931|BG001|Baseline|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095016|NCT01555931|BG002|Baseline|Total|Total of all reporting groups
11095017|NCT01555931|FG000|Participant Flow|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095018|NCT01555931|FG001|Participant Flow|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095019|NCT01555931|OG000|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095020|NCT01555931|OG001|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095021|NCT01555931|EG000|Reported Event|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095022|NCT01555931|EG001|Reported Event|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
11095023|NCT01555957|BG000|Baseline|Low Dose Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095024|NCT01555957|BG001|Baseline|High Dose of Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095025|NCT01555957|BG002|Baseline|Total|Total of all reporting groups
11095026|NCT01555957|FG000|Participant Flow|Low Dose Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095027|NCT01555957|FG001|Participant Flow|High Dose of Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095028|NCT01555957|OG000|Outcome|Low Dose Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095029|NCT01555957|OG001|Outcome|High Dose of Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095030|NCT01555957|EG000|Reported Event|Low Dose Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095031|NCT01555957|EG001|Reported Event|High Dose of Intravenous Lipids|intravenous lipid: intravenous given daily for 6 weeks
11095032|NCT01555983|BG000|Baseline|All Study Participants|All participants received all interventions
11095033|NCT01555983|FG000|Participant Flow|Placebo First, Then 2.9%THC, Then 6.7% THC|Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).
11095034|NCT01555983|FG001|Participant Flow|Placebo First, Then 6.7%THC, Then 2.9%THC|Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
11095035|NCT01555983|FG002|Participant Flow|2.9%THC First, Then Placebo, Then 6.7%THC|2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)
11095036|NCT01555983|FG003|Participant Flow|2.9%THC First, Then 6.7%THC, Then Placebo|2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
11095037|NCT01555983|FG004|Participant Flow|6.7%THC First, Then Placebo, Then 2.9%THC|6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
11314301|NCT03213405|FG003|Participant Flow|rBCG-N-hRSV Full Dose|"Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV full dose: 1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314302|NCT03213405|OG000|Outcome|Conventional BCG Full Dose|"Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.~Conventional BCG full dose: 2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection."
11314303|NCT03213405|OG001|Outcome|rBCG-N-hRSV 1/100 Dose|"Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/100: 5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314304|NCT03213405|OG002|Outcome|rBCG-N-hRSV 1/10 Dose|"Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/10: 5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314305|NCT03213405|OG003|Outcome|rBCG-N-hRSV Full Dose|"Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV full dose: 1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314306|NCT03213405|EG000|Reported Event|Conventional BCG Full Dose|"Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry.~Conventional BCG full dose: 2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection."
11314307|NCT03213405|EG001|Reported Event|rBCG-N-hRSV 1/100 Dose|"Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/100: 5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314308|NCT03213405|EG002|Reported Event|rBCG-N-hRSV 1/10 Dose|"Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV 1/10: 5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314309|NCT03213405|EG003|Reported Event|rBCG-N-hRSV Full Dose|"Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry.~rBCG-N-hRSV full dose: 1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection."
11314310|NCT03213509|BG000|Baseline|Participant Interviewed for Verbal Autopsy, Intervention Arm|Participant interviewed for verbal autopsy regarding a perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the intervention arm of the BetterBirth Trial
11314311|NCT03213509|BG001|Baseline|Participant Interviewed for Verbal Autopsy, Control Arm|Participant interviewed for verbal autopsy regarding a perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the control arm of the BetterBirth Trial
11314312|NCT03213509|BG002|Baseline|Total|Total of all reporting groups
11314313|NCT03213509|FG000|Participant Flow|Participant Interviewed for Verbal Autopsy, Intervention Arm|Individual who was interviewed about a perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the intervention arm of the BetterBirth Trial
11314314|NCT03213509|FG001|Participant Flow|Participant Interviewed for Verbal Autopsy, Control Arm|Individual who was interviewed about a perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the control arm of the BetterBirth Trial
11314315|NCT03213509|OG000|Outcome|Perinatal Death With Pause Point(s) Observed, Intervention Arm|Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the intervention arm of the BetterBirth Trial
11314316|NCT03213509|OG001|Outcome|Perinatal Death With Pause Point(s) Observed, Control Arm|Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the control arm of the BetterBirth Trial
11314317|NCT03213509|OG000|Outcome|Perinatal Death With Pause Point(s) Observed, Intervention Arm|Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the intervention arm of the BetterBirth Trial.
11314318|NCT03213509|OG001|Outcome|Perinatal Death With Pause Point(s) Observed, Control Arm|Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the control arm of the BetterBirth Trial.
11314319|NCT03213509|EG000|Reported Event|Interview (Social and Verbal Autopsy)|"The study involves administering verbal and social autopsies for BetterBirth Trial Participants who experienced a neonatal or perinatal death.~Interview (Social and Verbal Autopsy): Verbal autopsy is a technique used to determine the cause of death by asking caregivers, friends or family members about signs and symptoms exhibited by the deceased in the period before death. This is usually done using a standardized questionnaire that collects details on signs, symptoms, complaints and any medical history or events. The cause of death, or the sequence of causes that led to death, are assigned based on the data collected by this questionnaire and on any other available information. The social autopsy tool is used in conjunction with the verbal autopsy tool to explore the non-biological factors contributing to a death, including the social, behavioural and health systems determinants of maternal and child deaths."
11314320|NCT03213626|BG000|Baseline|Cabozantinib + Erlotinib|"Cabozantinib 40 MG: To be taken orally once daily~Erlotinib 100Mg Tab: To be taken orally once daily"
11314321|NCT03213626|FG000|Participant Flow|Cabozantinib + Erlotinib|"Cabozantinib 40 MG: To be taken orally once daily~Erlotinib 100Mg Tab: To be taken orally once daily"
11314322|NCT03213626|OG000|Outcome|Cabozantinib + Erlotinib|"Cabozantinib 40 MG: To be taken orally once daily~Erlotinib 100Mg Tab: To be taken orally once daily"
11314323|NCT03213626|EG000|Reported Event|Cabozantinib + Erlotinib|"Cabozantinib 40 MG: To be taken orally once daily~Erlotinib 100Mg Tab: To be taken orally once daily"
11314324|NCT03213938|BG000|Baseline|Acupuncture|"The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.~Acupuncture: For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.~Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314325|NCT03213938|BG001|Baseline|Sham Acupuncture|"The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.~Sham acupuncture: For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.~Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314326|NCT03213938|BG002|Baseline|Total|Total of all reporting groups
11314327|NCT03213938|FG000|Participant Flow|Acupuncture|"The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.~Acupuncture: For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.~Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314328|NCT03213938|FG001|Participant Flow|Sham Acupuncture|"The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.~Sham acupuncture: For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.~Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314329|NCT03213938|OG000|Outcome|Acupuncture|"The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.~Acupuncture: For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.~Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314330|NCT03213938|OG001|Outcome|Sham Acupuncture|"The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.~Sham acupuncture: For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.~Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314331|NCT03213938|EG000|Reported Event|Acupuncture|"The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.~Acupuncture: For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.~Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314332|NCT03213938|EG001|Reported Event|Sham Acupuncture|"The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.~Sham acupuncture: For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.~Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
11314333|NCT03214081|BG000|Baseline|Vonoprazan 10 mg or 20 mg|Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
11314334|NCT03214081|FG000|Participant Flow|Vonoprazan 10 mg or 20 mg|Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
11314335|NCT03214081|OG000|Outcome|Vonoprazan 10 mg or 20 mg|Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
11314336|NCT03214081|EG000|Reported Event|Vonoprazan 10 mg or 20 mg|Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care.
11314337|NCT03214094|BG000|Baseline|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314338|NCT03214094|FG000|Participant Flow|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314339|NCT03214094|OG000|Outcome|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314340|NCT03214094|EG000|Reported Event|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314341|NCT03214198|BG000|Baseline|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314342|NCT03214198|FG000|Participant Flow|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314343|NCT03214198|OG000|Outcome|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314344|NCT03214198|EG000|Reported Event|Vonoprazan 10 mg|The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.
11314345|NCT03214224|BG000|Baseline|Remote PFT (rPFT) Validation|Subjects perform both standard and remote PFT assessments in order to validate the procedure.
11314346|NCT03214224|FG000|Participant Flow|Remote PFT (rPFT) Validation|Those in the first part of the study will perform both standard and remote PFT assessments in order to validate the procedure.
11314347|NCT03214224|OG000|Outcome|Remote PFT (rPFT) Validation|"Those in the first part of the study will perform both standard and remote PFT assessments in order to validate the procedure.~remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)~standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)"
11314348|NCT03214224|EG000|Reported Event|Remote PFT (rPFT) Validation|"Those in the first part of the study will perform both standard and remote PFT assessments in order to validate the procedure.~remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)~standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)"
11314349|NCT03214367|BG000|Baseline|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314350|NCT03214367|BG001|Baseline|LY900014|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314351|NCT03214367|BG002|Baseline|LY900014 Postmeal|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314352|NCT03214367|BG003|Baseline|Insulin Lispro (Humalog)-MEE|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314353|NCT03214367|BG004|Baseline|LY900014-MEE|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314354|NCT03214367|BG005|Baseline|LY900014 Postmeal-MEE|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314355|NCT03214367|BG006|Baseline|Total|Total of all reporting groups
11314356|NCT03214367|FG000|Participant Flow|Insulin Lispro (Humalog) Lead-in|100 units per milliliter (U/mL) Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314357|NCT03214367|FG001|Participant Flow|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314358|NCT03214367|FG002|Participant Flow|LY900014|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314359|NCT03214367|FG003|Participant Flow|LY900014 Postmeal|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314360|NCT03214367|FG004|Participant Flow|Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314361|NCT03214367|FG005|Participant Flow|Insulin Lispro (Humalog)- Maximum Extended Enrollment (MEE)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314362|NCT03214367|FG006|Participant Flow|LY900014-MEE|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314363|NCT03214367|FG007|Participant Flow|LY900014 Postmeal-MEE|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314364|NCT03214367|OG000|Outcome|LY900014|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314365|NCT03214367|OG001|Outcome|LY900014 Postmeal|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314366|NCT03214367|OG002|Outcome|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314367|NCT03214367|OG001|Outcome|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
10827293|NCT00108745|FG000|Participant Flow|Arm I (Paclitaxel Poliglumex)|"Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel Poliglumex: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827294|NCT00108745|FG001|Participant Flow|Arm II (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827295|NCT00108745|FG002|Participant Flow|Arm III (Observation)|"Patients receive no further anticancer treatment until evidence of disease progression.~Clinical Observation: Undergo observation~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
10827296|NCT00108745|OG000|Outcome|Arm I (Paclitaxel Poliglumex)|"Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel Poliglumex: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827297|NCT00108745|OG001|Outcome|Arm II (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827298|NCT00108745|OG002|Outcome|Arm III (Observation)|"Patients receive no further anticancer treatment until evidence of disease progression.~Clinical Observation: Undergo observation~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
10827299|NCT00108745|EG000|Reported Event|Arm I (Paclitaxel Poliglumex)|"Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel Poliglumex: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827300|NCT00108745|EG001|Reported Event|Arm II (Paclitaxel)|"Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
10827301|NCT00108745|EG002|Reported Event|Arm III (Observation)|"Patients receive no further anticancer treatment until evidence of disease progression.~Clinical Observation: Undergo observation~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
10827302|NCT00108862|BG000|Baseline|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
10827303|NCT00108862|BG001|Baseline|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
10827304|NCT00108862|BG002|Baseline|Total|Total of all reporting groups
10827305|NCT00108862|FG000|Participant Flow|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
10827306|NCT00108862|FG001|Participant Flow|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
10848559|NCT00290433|EG000|Reported Event|HCVIDDOXIL Regimen|"Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.~Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3."
11314368|NCT03214367|EG000|Reported Event|Insulin Lispro (Humalog) Lead-in|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314369|NCT03214367|EG001|Reported Event|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314370|NCT03214367|EG002|Reported Event|LY900014|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314371|NCT03214367|EG003|Reported Event|LY900014 Postmeal|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314372|NCT03214367|EG004|Reported Event|Insulin Lispro (Humalog) Lead-in-MEE|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314373|NCT03214367|EG005|Reported Event|Insulin Lispro (Humalog)-MEE|100 U/mL Insulin lispro given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314374|NCT03214367|EG006|Reported Event|LY900014-MEE|100 U/mL LY900014 given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
11314375|NCT03214367|EG007|Reported Event|LY900014 Postmeal-MEE|100 U/mL LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314376|NCT03214380|BG000|Baseline|Insulin Lispro (Humalog)|Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314377|NCT03214380|BG001|Baseline|LY900014|LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314378|NCT03214380|BG002|Baseline|Insulin Lispro (Humalog) MEE|Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314379|NCT03214380|BG003|Baseline|LY900014 Maximum Extended Enrollment (MEE)|LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314380|NCT03214380|BG004|Baseline|Total|Total of all reporting groups
11314381|NCT03214380|FG000|Participant Flow|Insulin Lispro (Humalog) Lead-In|100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314382|NCT03214380|FG001|Participant Flow|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314383|NCT03214380|FG002|Participant Flow|LY900014|100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314384|NCT03214380|FG003|Participant Flow|Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment|100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314385|NCT03214380|FG004|Participant Flow|Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)|100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314386|NCT03214380|FG005|Participant Flow|LY900014 (MEE)|100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314387|NCT03214380|OG000|Outcome|Insulin Lispro (Humalog)|Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314388|NCT03214380|OG001|Outcome|LY900014|LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314389|NCT03214380|OG000|Outcome|Insulin Lispro (Humalog)|Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
11314390|NCT03214380|OG001|Outcome|LY900014|LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
10827307|NCT00108862|OG000|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
10827308|NCT00108862|OG001|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
10827309|NCT00108862|EG000|Reported Event|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
10827310|NCT00108862|EG001|Reported Event|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
10827311|NCT00108953|BG000|Baseline|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827312|NCT00108953|BG001|Baseline|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827313|NCT00108953|BG002|Baseline|Total|Total of all reporting groups
10827314|NCT00108953|FG000|Participant Flow|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827315|NCT00108953|FG001|Participant Flow|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
11095038|NCT01555983|FG005|Participant Flow|6.7%THC First, Then 2.9%THC, Then Placebo|6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
10827316|NCT00108953|OG000|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827317|NCT00108953|OG001|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827318|NCT00108953|OG000|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827319|NCT00108953|OG001|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827320|NCT00108953|EG000|Reported Event|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827321|NCT00108953|EG001|Reported Event|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
10827322|NCT00109005|BG000|Baseline|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
10827323|NCT00109005|BG001|Baseline|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
10827324|NCT00109005|BG002|Baseline|Total|Total of all reporting groups
11095039|NCT01555983|OG000|Outcome|Placebo THC|Session at which placebo THC was administered
11314391|NCT03214380|EG000|Reported Event|Insulin Lispro (Humalog) Lead-In|100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314392|NCT03214380|EG001|Reported Event|Insulin Lispro (Humalog)|100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314393|NCT03214380|EG002|Reported Event|LY900014|100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314394|NCT03214380|EG003|Reported Event|Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment|100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314395|NCT03214380|EG004|Reported Event|Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)|100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314396|NCT03214380|EG005|Reported Event|LY900014 (MEE)|100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
11314397|NCT03214406|BG000|Baseline|Arm & Hammer Advance White Brilliant Sparkle (Test Product)|"2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product)~Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate"
11314398|NCT03214406|BG001|Baseline|Crest Cavity Protection Regular Toothpaste (Negative Control)|"2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control)~Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control"
11314399|NCT03214406|BG002|Baseline|Total|Total of all reporting groups
11314400|NCT03214406|FG000|Participant Flow|Arm & Hammer Advance White Brilliant Sparkle (Test Product)|"2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product)~Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate"
11314401|NCT03214406|FG001|Participant Flow|Crest Cavity Protection Regular Toothpaste (Negative Control)|"2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control)~Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control"
11314402|NCT03214406|OG000|Outcome|Arm & Hammer Advance White Brilliant Sparkle (Test Product)|"2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product)~Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate"
11314403|NCT03214406|OG001|Outcome|Crest Cavity Protection Regular Toothpaste (Negative Control)|"2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control)~Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control"
11314404|NCT03214406|EG000|Reported Event|Arm & Hammer Advance White Brilliant Sparkle (Test Product)|"2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product)~Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate"
11314405|NCT03214406|EG001|Reported Event|Crest Cavity Protection Regular Toothpaste (Negative Control)|"2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control)~Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control"
11314406|NCT03214588|BG000|Baseline|Placebo|TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
11314407|NCT03214588|BG001|Baseline|TAK-831 75 mg|TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
11314408|NCT03214588|BG002|Baseline|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
11314409|NCT03214588|BG003|Baseline|Total|Total of all reporting groups
11314410|NCT03214588|FG000|Participant Flow|Placebo|TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
11314411|NCT03214588|FG001|Participant Flow|TAK-831 75 mg|TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
11314412|NCT03214588|FG002|Participant Flow|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
11314413|NCT03214588|OG000|Outcome|Placebo|TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
11314414|NCT03214588|OG001|Outcome|TAK-831 75 mg|TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
11314415|NCT03214588|OG002|Outcome|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
11314416|NCT03214588|EG000|Reported Event|Placebo|TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
11314417|NCT03214588|EG001|Reported Event|TAK-831 75 mg|TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
11314418|NCT03214588|EG002|Reported Event|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
11314419|NCT03214640|BG000|Baseline|Palpation With Spinal Block (Group C-P)|"insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
10827325|NCT00109005|FG000|Participant Flow|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
10827326|NCT00109005|FG001|Participant Flow|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
10827327|NCT00109005|OG000|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
10827328|NCT00109005|OG000|Outcome|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
10827329|NCT00109005|OG001|Outcome|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
10827330|NCT00109005|EG000|Reported Event|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
10827331|NCT00109005|EG001|Reported Event|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
10827332|NCT00109031|BG000|Baseline|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
10827333|NCT00109031|BG001|Baseline|Palifermin 180 μg/kg on Day -1|Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827334|NCT00109031|BG002|Baseline|Palifermin 180 μg/kg on Day -2|Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827335|NCT00109031|BG003|Baseline|Palifermin 180 μg/kg on Day -3|Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827336|NCT00109031|BG004|Baseline|Total|Total of all reporting groups
10827337|NCT00109031|FG000|Participant Flow|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
10827338|NCT00109031|FG001|Participant Flow|Palifermin 180 μg/kg on Day -1|Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
10827339|NCT00109031|FG002|Participant Flow|Palifermin 180 μg/kg on Day -2|Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
10827340|NCT00109031|FG003|Participant Flow|Palifermin 180 μg/kg on Day -3|Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
10827341|NCT00109031|OG000|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
10827342|NCT00109031|OG001|Outcome|Palifermin 180 μg/kg on Day -1|Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827343|NCT00109031|OG002|Outcome|Palifermin 180 μg/kg on Day -2|Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827344|NCT00109031|OG003|Outcome|Palifermin 180 μg/kg on Day -3|Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827345|NCT00109031|EG000|Reported Event|Palifermin 60 µg/kg for 3 Days (A)|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
10827346|NCT00109031|EG001|Reported Event|Palifermin 180 μg/kg on Day -1 (B)|Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827347|NCT00109031|EG002|Reported Event|Palifermin 180 μg/kg on Day -2 (C)|Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827348|NCT00109031|EG003|Reported Event|Palifermin 180 μg/kg on Day -3 (D)|Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
10827349|NCT00109343|BG000|Baseline|Group 1 - ProQuad™ + PREVNAR™|Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
10827350|NCT00109343|BG001|Baseline|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
10827351|NCT00109343|BG002|Baseline|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
10827352|NCT00109343|BG003|Baseline|Total|Total of all reporting groups
10827353|NCT00109343|FG000|Participant Flow|Group 1 - ProQuad™ + PREVNAR™|Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
11095040|NCT01555983|OG001|Outcome|2.9% THC|Vaporization of Cannabis 2.9% THC
11095041|NCT01555983|OG002|Outcome|6.7% THC|Vaporization of Cannabis 6.7% THC
11314420|NCT03214640|BG001|Baseline|Palpation With Neuraxial Block (Group L-P)|"the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314421|NCT03214640|BG002|Baseline|Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314422|NCT03214640|BG003|Baseline|Rivanna Ultrasound Device With Neuraxial Block (Group L-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314423|NCT03214640|BG004|Baseline|Total|Total of all reporting groups
11314424|NCT03214640|FG000|Participant Flow|Palpation With Spinal Block (Group C-P)|"insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314425|NCT03214640|FG001|Participant Flow|Palpation With Neuraxial Block (Group L-P)|"the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314426|NCT03214640|FG002|Participant Flow|Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314427|NCT03214640|FG003|Participant Flow|Rivanna Ultrasound Device With Neuraxial Block (Group L-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314428|NCT03214640|OG000|Outcome|Palpation With Spinal Block (Group C-P)|"insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314429|NCT03214640|OG001|Outcome|Palpation With Neuraxial Block (Group L-P)|"the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314430|NCT03214640|OG002|Outcome|Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314431|NCT03214640|OG003|Outcome|Rivanna Ultrasound Device With Neuraxial Block (Group L-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314432|NCT03214640|EG000|Reported Event|Palpation With Spinal Block (Group C-P)|"insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11333328|NCT03512041|BG002|Baseline|RLIC - 3 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11095042|NCT01555983|EG000|Reported Event|Placebo THC|Vaporization of Cannabis Placebo THC
11095043|NCT01555983|EG001|Reported Event|2.9% THC|Vaporization of Cannabis 2.9% THC
11314433|NCT03214640|EG001|Reported Event|Palpation With Neuraxial Block (Group L-P)|"the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia~Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314434|NCT03214640|EG002|Reported Event|Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care"
11314435|NCT03214640|EG003|Reported Event|Rivanna Ultrasound Device With Neuraxial Block (Group L-R)|"insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia~Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.~Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia"
11314436|NCT03214952|BG000|Baseline|Vonoprazan 20 mg|The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
11314437|NCT03214952|FG000|Participant Flow|Vonoprazan 20 mg|The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
11314438|NCT03214952|OG000|Outcome|Vonoprazan 20 mg|The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
11314439|NCT03214952|EG000|Reported Event|Vonoprazan 20 mg|The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
11314440|NCT03215667|BG000|Baseline|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions."
11314441|NCT03215667|FG000|Participant Flow|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions."
11314442|NCT03215667|OG000|Outcome|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions."
11314443|NCT03215667|EG000|Reported Event|Device Treatment|"easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane~easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions."
11314444|NCT03215758|BG000|Baseline|QAW039|QAW039 once daily
11314445|NCT03215758|BG001|Baseline|Placebo|Placebo once daily
11314446|NCT03215758|BG002|Baseline|Total|Total of all reporting groups
11314447|NCT03215758|FG000|Participant Flow|QAW039|QAW039 once daily
11314448|NCT03215758|FG001|Participant Flow|Placebo|Placebo once daily
11314449|NCT03215758|OG000|Outcome|QAW039|QAW039 once daily
11314450|NCT03215758|OG001|Outcome|Placebo|Placebo once daily
11314451|NCT03215758|EG000|Reported Event|QAW039 150 mg|QAW039 150 mg
11314452|NCT03215758|EG001|Reported Event|Placebo|Placebo
11314453|NCT03215771|BG000|Baseline|MyoPro + Motor Based Learning|"Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program.~MyoPro Motion-G: The MyoPro Motion-G is a custom-fabricated elbow-wrist-hand myoelectric orthosis."
11314454|NCT03215771|FG000|Participant Flow|MyoPro + Motor Based Learning|"Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program.~MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis."
11314455|NCT03215771|OG000|Outcome|MyoPro + Motor Based Learning|"Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program.~MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis."
11314456|NCT03215771|OG000|Outcome|MyoPro + Motor Based Learning|"Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program.~MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis."
11314457|NCT03215771|EG000|Reported Event|MyoPro + Motor Based Learning|"Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis.~MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis."
11314458|NCT03215901|BG000|Baseline|A Beautiful Future Video|"Participants randomized to intervention will view intervention video.~A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area."
11314459|NCT03215901|BG001|Baseline|Active Control Video|"Participants randomized to control will watch a video of similar length as the intervention video on a different topic.~Active Control Video: Video on another topic."
11314460|NCT03215901|BG002|Baseline|Pure Control|Participants view no video.
11314461|NCT03215901|BG003|Baseline|Total|Total of all reporting groups
11314462|NCT03215901|FG000|Participant Flow|A Beautiful Future Video|"Participants randomized to intervention will view intervention video.~A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area."
11314463|NCT03215901|FG001|Participant Flow|Active Control Video|"Participants randomized to control will watch a video of similar length as the intervention video on a different topic.~Active Control Video: Video on another topic."
10827354|NCT00109343|FG001|Participant Flow|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
11314464|NCT03215901|FG002|Participant Flow|Pure Control|Participants view no video.
11314465|NCT03215901|OG000|Outcome|A Beautiful Future Video|"Participants randomized to intervention will view intervention video.~A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area."
11314466|NCT03215901|OG001|Outcome|Active Control Video|"Participants randomized to control will watch a video of similar length as the intervention video on a different topic.~Active Control Video: Video on another topic."
11314467|NCT03215901|OG002|Outcome|Pure Control|Participants view no video.
11314468|NCT03215901|EG000|Reported Event|A Beautiful Future Video|"Participants randomized to intervention will view intervention video.~A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area."
11314469|NCT03215901|EG001|Reported Event|Active Control Video|"Participants randomized to control will watch a video of similar length as the intervention video on a different topic.~Active Control Video: Video on another topic."
11314470|NCT03215901|EG002|Reported Event|Pure Control|Participants view no video.
11314471|NCT03216200|BG000|Baseline|Experimental|"5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~plasma treatment: application of cold atmospheric plasma to a fungal infected toenail"
11314472|NCT03216200|FG000|Participant Flow|Experimental|"5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~plasma treatment: application of cold atmospheric plasma to a fungal infected toenail"
11314473|NCT03216200|OG000|Outcome|Experimental|"5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~plasma treatment: application of cold atmospheric plasma to a fungal infected toenail"
11314474|NCT03216200|EG000|Reported Event|Experimental|"5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.~plasma treatment: application of cold atmospheric plasma to a fungal infected toenail"
11314475|NCT03216226|BG000|Baseline|Dasiglucagon (ZP4207)|"3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose.~dasiglucagon: Glucagon Analog"
11314476|NCT03216226|BG001|Baseline|GlucaGen|"3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose.~GlucaGen: Native Glucagon"
11314477|NCT03216226|BG002|Baseline|Total|Total of all reporting groups
11314478|NCT03216226|FG000|Participant Flow|Dasiglucagon (ZP4207)|"3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose.~dasiglucagon: Glucagon Analog"
11314479|NCT03216226|FG001|Participant Flow|GlucaGen|"3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose.~GlucaGen: Native Glucagon"
11314480|NCT03216226|OG000|Outcome|Dasiglucagon (ZP4207)|"3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose.~dasiglucagon: Glucagon Analog"
11314481|NCT03216226|OG001|Outcome|GlucaGen|"3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose.~GlucaGen: Native Glucagon"
11314482|NCT03216226|EG000|Reported Event|Dasiglucagon (ZP4207)|"3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose.~dasiglucagon: Glucagon Analog"
11314483|NCT03216226|EG001|Reported Event|GlucaGen|"3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose.~GlucaGen: Native Glucagon"
11314484|NCT03216265|BG000|Baseline|No Treatment/ Test Product|Participants randomized to this arm applied Test product at allocated side and left other sites untreated.
11314485|NCT03216265|BG001|Baseline|No Treatment/ Positive Control|Participants randomized to this arm applied Positive product at allocated sites and left other side untreated.
11314486|NCT03216265|BG002|Baseline|Test Product/ Positive Control|Participants randomized to this arm applied Test and positive product at allocated side.
11314487|NCT03216265|BG003|Baseline|Total|Total of all reporting groups
11314488|NCT03216265|FG000|Participant Flow|No Treatment/ Test Product|Participants randomized to this arm applied Test product at allocated side and left other sites untreated.
11314489|NCT03216265|FG001|Participant Flow|No Treatment/ Positive Control|Participants randomized to this arm applied Positive product at allocated sites and left other side untreated.
11314490|NCT03216265|FG002|Participant Flow|Test Product/ Positive Control|Participants randomized to this arm applied Test and positive product at allocated side.
11314491|NCT03216265|OG000|Outcome|Test Product|Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
10827355|NCT00109343|FG002|Participant Flow|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
11095044|NCT01555983|EG002|Reported Event|6.7% THC|Vaporization of Cannabis 6.7% THC
11314492|NCT03216265|OG001|Outcome|No Treatment|Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
11314493|NCT03216265|OG001|Outcome|Positive Control|Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study.
11314494|NCT03216265|OG002|Outcome|No Treatment|Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
11314495|NCT03216265|OG000|Outcome|Positive Control|Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study
11314496|NCT03216265|OG001|Outcome|Test Product|Data of this arm included all allotted sides of the face of the participant where test product was applied during the study.
11314497|NCT03216265|OG002|Outcome|No Treatment|Data of this arm included all allotted sides of the face of the participant which were left untreated during the study.
11314498|NCT03216265|OG000|Outcome|Positive Control|Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study.
11314499|NCT03216265|OG001|Outcome|Test Product|Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
11314500|NCT03216265|EG000|Reported Event|Test Product|Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
11314501|NCT03216265|EG001|Reported Event|Positive Control|Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study.
11314502|NCT03216265|EG002|Reported Event|No Treatment|Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
11314503|NCT03216265|EG003|Reported Event|Overall Participants|Included all participants who applied any of the study products.
11314504|NCT03216382|BG000|Baseline|Attention Training Technique|"Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task."
11314505|NCT03216382|BG001|Baseline|Control Condition|"Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions."
11314506|NCT03216382|BG002|Baseline|Total|Total of all reporting groups
11314507|NCT03216382|FG000|Participant Flow|Attention Training Technique|"Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task."
11314508|NCT03216382|FG001|Participant Flow|Control Condition|"Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions."
11314509|NCT03216382|OG000|Outcome|Attention Training Technique|"Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task."
11314510|NCT03216382|OG001|Outcome|Control Condition|"Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions."
11314511|NCT03216382|EG000|Reported Event|Attention Training Technique|"Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task."
11314512|NCT03216382|EG001|Reported Event|Control Condition|"Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.~Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions."
11314513|NCT03216512|BG000|Baseline|Noise Cancelling Headphone First, Then Sham Control Headphone|"This group will use the noise cancelling headphone during the first experimental session as they complete study assessments. They will then return within a week, for experimental session day 2, to complete the same assessments this time using a sham control headphone.~Use of Noise Cancelling Headphones: During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions."
11314514|NCT03216512|BG001|Baseline|Sham Control Headphone First, Then Noise Cancelling Headphone|"This group will use the sham control headphone during the first experimental session as they complete study assessments. They will then return within a week for experimental session day 2, to redo the same assessments this time using a noise cancelling headphone.~Use of Noise Cancelling Headphones: During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions."
11314515|NCT03216512|BG002|Baseline|Total|Total of all reporting groups
11314516|NCT03216512|FG000|Participant Flow|Noise Cancelling Headphone First, Then Sham Control Headphone|"This group will use the noise cancelling headphone during the first experimental session as they complete study assessments. They will then return within a week, for experimental session day 2, to complete the same assessments this time using a sham control headphone.~Use of Noise Cancelling Headphones: During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions."
11314517|NCT03216512|FG001|Participant Flow|Sham Control Headphone First, Then Noise Cancelling Headphone|"This group will use the sham control headphone during the first experimental session as they complete study assessments. They will then return within a week for experimental session day 2, to redo the same assessments this time using a noise cancelling headphone.~Use of Noise Cancelling Headphones: During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions."
11314518|NCT03216512|OG000|Outcome|Change From Baseline for NC Condition|This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
11314519|NCT03216512|OG001|Outcome|Change From Baseline for Sham Condition|This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
11314520|NCT03216512|OG000|Outcome|NC Condition|This is the mean of the self-reported rating for the sessions
11314521|NCT03216512|OG001|Outcome|Sham Condition|This is the mean of the self-reported rating for the sessions
11314522|NCT03216512|EG000|Reported Event|Noise Cancelling Headphones|This arm is during sessions when participants received noise cancelling headphones
11314523|NCT03216512|EG001|Reported Event|Sham Control Headphones|This arm is during sessions when participants received sham control headphones
11314524|NCT03216746|BG000|Baseline|Oral Orientation Without App|This group comprised of 79 adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher.
11314525|NCT03216746|BG001|Baseline|Video Without App|This group comprised of 69 adolescents from 14 to 19 years of age who received a video orientation.
11314526|NCT03216746|BG002|Baseline|Oral Orientation With App|This group comprised of 72 adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher and also from an App developed specifically for this study.
11314527|NCT03216746|BG003|Baseline|Video With App|This group comprised of 68 adolescents from 14 to 19 years of age who received a video orientation and also from an App developed specifically for this study.
11314528|NCT03216746|BG004|Baseline|Total|Total of all reporting groups
10827356|NCT00109343|OG000|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
10827357|NCT00109343|OG001|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
10827358|NCT00109343|OG001|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
10827359|NCT00109343|EG000|Reported Event|ProQuad™ + Prevnar™ (After Dose 1)|ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)
10827360|NCT00109343|EG001|Reported Event|ProQuad™ Alone (After Dose 1)|ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).
10827361|NCT00109343|EG002|Reported Event|ProQuad™ (After Dose 2)|ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
10827362|NCT00109473|BG000|Baseline|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
10827363|NCT00109473|BG001|Baseline|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
10827364|NCT00109473|BG002|Baseline|Total|Total of all reporting groups
10827365|NCT00109473|FG000|Participant Flow|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
10827366|NCT00109473|FG001|Participant Flow|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
10827367|NCT00109473|OG000|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
10827368|NCT00109473|OG001|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
10827369|NCT00109473|OG000|Outcome|Growth Hormone Plus Cortecosteroid|"Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)~growth hormone: Nutropin AQ 0.075mg/kg/day subcutaneously daily"
10827370|NCT00109473|OG001|Outcome|Cortecosteroids Alone|"Cortecosteroid therapy as prescribed by the referring gastroenterologist~cortecosteroid: As prescribed by the referring gastroenterologist"
10827371|NCT00109473|EG000|Reported Event|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
10827372|NCT00109473|EG001|Reported Event|Corticosteroid (CTX)|Subjects took corticosteroid as recommended by their physician
10827373|NCT00109473|EG002|Reported Event|Extension Phase|Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
10827374|NCT00109577|BG000|Baseline|Placebo Comparator|Placebo comparator
10827375|NCT00109577|BG001|Baseline|Micronutrient Formula|nutritional supplement
10827376|NCT00109577|BG002|Baseline|Total|Total of all reporting groups
10827377|NCT00109577|FG000|Participant Flow|Placebo Comparator|Placebo comparator capsules
10827378|NCT00109577|FG001|Participant Flow|Micronutrient Formula|nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
10827379|NCT00109577|OG000|Outcome|Placebo Comparator|Placebo comparator capsules
10827380|NCT00109577|OG001|Outcome|Micronutrient Formula|nutritional supplement capsules
10827381|NCT00109577|EG000|Reported Event|Placebo Comparator|Placebo comparator
10827382|NCT00109577|EG001|Reported Event|Micronutrient Formula|nutritional supplement
10827383|NCT00109590|BG000|Baseline|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
10827384|NCT00109590|BG001|Baseline|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
10827385|NCT00109590|BG002|Baseline|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827386|NCT00109590|BG003|Baseline|Total|Total of all reporting groups
10827387|NCT00109590|FG000|Participant Flow|Arm A : LPV/r x 7d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum,> Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
10827388|NCT00109590|FG001|Participant Flow|Arm B : no LPV/r|Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
11095045|NCT01556061|BG000|Baseline|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
11314529|NCT03216746|FG000|Participant Flow|Oral Orientation With App|"The oral health educational method of this group comprised a total of 72 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.~Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes."
11314530|NCT03216746|FG001|Participant Flow|Oral Orientation Without App|"The oral health educational method of this group comprised a total of 79 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. In this group, participants did not receive the App for smartphone.~Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes."
11314531|NCT03216746|FG002|Participant Flow|Video With App|"The oral health educational method of this group comprised a total of 68 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.~Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes."
11314532|NCT03216746|FG003|Participant Flow|Video Without App|"The oral health educational method of this group comprised a total of 69 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. In this group, participants did not receive the App for smartphone.~Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes."
11314533|NCT03216746|OG000|Outcome|Oral Orientation|This group comprised 79 participants who received only oral orientation by a previously trained researcher.
11314534|NCT03216746|OG001|Outcome|Oral Orientation and App|This group comprised 72 participants who received orientation through oral orientation and also an App.
11314535|NCT03216746|OG002|Outcome|Video Orientation|This group comprised 69 adolescents who received orientation through a video.
11314536|NCT03216746|OG003|Outcome|Video Orientation and App|This group comprised 68 adolescents who received orientation through video and also an App.
11314537|NCT03216746|EG000|Reported Event|Oral Orientation Without App|This group comprised of adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher.
11314538|NCT03216746|EG001|Reported Event|Video Without App|This group comprised of adolescents from 14 to 19 years of age who received a video orientation.
11314539|NCT03216746|EG002|Reported Event|Oral Orientation With App|This group comprised of adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher and also from an App developed specifically for this study.
11314540|NCT03216746|EG003|Reported Event|Video With App|This group comprised of 68 adolescents from 14 to 19 years of age who received a video orientation and also from an App developed specifically for this study.
11314541|NCT03216850|BG000|Baseline|Patients in ICU Requiring Parenteral Nutrition|Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
11314542|NCT03216850|FG000|Participant Flow|Patients in ICU Requiring Parenteral Nutrition|Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
11314543|NCT03216850|OG000|Outcome|Patients in ICU Requiring Parenteral Nutrition|Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
11314544|NCT03216850|EG000|Reported Event|Patients in ICU Requiring Parenteral Nutrition|Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
11314545|NCT03216902|BG000|Baseline|Placebo (Vehicle of DE-126) Followed by High Dose of DE-126|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
11314546|NCT03216902|BG001|Baseline|0.005% Latanoprost|0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
11314547|NCT03216902|BG002|Baseline|Ultra-low Dose 0.0005% DE-126|Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314548|NCT03216902|BG003|Baseline|Low Dose 0.001% DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314549|NCT03216902|BG004|Baseline|Medium Dose 0.002% DE-126|Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314550|NCT03216902|BG005|Baseline|High Dose 0.003% DE-126|Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314551|NCT03216902|BG006|Baseline|Total|Total of all reporting groups
11314552|NCT03216902|FG000|Participant Flow|Placebo (Vehicle of DE-126) Followed by High Dose of DE-126|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
11314553|NCT03216902|FG001|Participant Flow|0.005% Latanoprost|0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
11314554|NCT03216902|FG002|Participant Flow|Ultra-low Dose 0.0005% DE-126|Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314555|NCT03216902|FG003|Participant Flow|Low Dose 0.001% DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314556|NCT03216902|FG004|Participant Flow|Medium Dose 0.002% DE-126|Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314557|NCT03216902|FG005|Participant Flow|High Dose 0.003% DE-126|Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314558|NCT03216902|OG000|Outcome|Placebo (Vehicle of DE-126) Followed by High Dose of DE-126|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
11314559|NCT03216902|OG001|Outcome|0.005% Latanoprost|0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
11314560|NCT03216902|OG002|Outcome|Ultra-low Dose 0.0005% DE-126|Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314561|NCT03216902|OG003|Outcome|Low Dose 0.001% DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314562|NCT03216902|OG004|Outcome|Medium Dose 0.002% DE-126|Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314563|NCT03216902|OG005|Outcome|High Dose 0.003% DE-126|Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314564|NCT03216902|OG001|Outcome|Ultra-low Dose 0.0005% DE-126|Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11095046|NCT01556061|BG001|Baseline|D-MAC First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
11314565|NCT03216902|OG002|Outcome|Low Dose 0.001% DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314566|NCT03216902|OG003|Outcome|Medium Dose 0.002% DE-126|Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314567|NCT03216902|OG004|Outcome|High Dose 0.003% DE-126|Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314568|NCT03216902|OG003|Outcome|0.001% Low Dose DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314569|NCT03216902|EG000|Reported Event|Placebo P1|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks.
11314570|NCT03216902|EG001|Reported Event|Placebo P2|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3.
11314571|NCT03216902|EG002|Reported Event|0.005% Latanoprost|0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
11314572|NCT03216902|EG003|Reported Event|Ultra-low Dose DE-126|Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314573|NCT03216902|EG004|Reported Event|Low Dose DE-126|Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314574|NCT03216902|EG005|Reported Event|Medium Dose DE-126|Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314575|NCT03216902|EG006|Reported Event|High Dose of DE-126|Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
11314576|NCT03216902|EG007|Reported Event|High Dose of DE-126 Total|Summarizes columns High dose of DE-126 and Placebo P2
11314577|NCT03216902|EG008|Reported Event|DE-126 Total|Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2.
11314578|NCT03216954|BG000|Baseline|Crossover Study Drug Conditions|"Subjects received oral placebo, 0.6 g n-acetylcysteine or 1.2 g n-acetylcysteine capsules two times daily. Dose condition was assigned in random order and all completing subjects received all dose conditions.~Alcohol: During each condition, subjects received doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~Placebos: Subjects received placebo capsules. n-Acetylcysteine: Subjects received n-acetylcysteine capsules."
11314579|NCT03216954|FG000|Participant Flow|Placebo Then 1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine|Subjects were maintained on placebo for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
11314580|NCT03216954|FG001|Participant Flow|2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on placebo for 5 days.
11314581|NCT03216954|FG002|Participant Flow|Placebo Then 2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine|Subjects were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine, then they were maintained on 1.2 g n-acetylcysteine.
11314582|NCT03216954|FG003|Participant Flow|1.2 g n-Acetylcysteine Then Placebo Then 2.4 g n-Acetylcysteine|Subjects were maintained on 1.2 g n-acetylcysteine for 5 days, then they were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
11314583|NCT03216954|FG004|Participant Flow|1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine Then Placebo|Subjects were maintained on 1.2 g n-acetylcysteine for 5 days then they were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on placebo.
11314584|NCT03216954|OG000|Outcome|Placebo|"Subjects received oral placebo capsules two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~Placebos: Subjects will receive placebo capsules"
11314585|NCT03216954|OG001|Outcome|Low Dose n-Acetylcysteine|"Subjects received 0.6 g oral n-acetylcysteine two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules"
11314586|NCT03216954|OG002|Outcome|High Dose n-Acetylcysteine|"Subjects received 1.2 g oral n-acetylcysteine two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules"
11314587|NCT03216954|EG000|Reported Event|Placebo Maintenance|"Subjects received oral placebo capsules two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~Placebos: Subjects received placebo capsules"
11314588|NCT03216954|EG001|Reported Event|1.2 g n-Acetylcysteine Maintenance|"Subjects received 0.6 g n-acetylcysteine capsules two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 0.6 g n-acetylcysteine capsules"
11314589|NCT03216954|EG002|Reported Event|2.4 g n-Acetylcysteine Maintenance|"Subjects received 1.2 g n-acetylcysteine capsules two times daily.~Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.~Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 1.2 g n-acetylcysteine capsules"
11333329|NCT03512041|BG003|Baseline|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All"
11333330|NCT03512041|BG004|Baseline|Total|Total of all reporting groups
11333331|NCT03512041|FG000|Participant Flow|RLIC - 5 Cycles|"Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants underg"
11333332|NCT03512041|FG001|Participant Flow|RLIC - 4 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11333333|NCT03512041|FG002|Participant Flow|RLIC - 3 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11333334|NCT03512041|FG003|Participant Flow|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All"
11314590|NCT03217968|BG000|Baseline|Active|"120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack~Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS)."
11314591|NCT03217968|FG000|Participant Flow|Active|"120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack~Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS)."
11314592|NCT03217968|OG000|Outcome|Active|"120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack~Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS)."
11314593|NCT03217968|EG000|Reported Event|Active|"120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack~Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS)."
11314594|NCT03218397|BG000|Baseline|Standard Blood Culture and AST|Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
11314595|NCT03218397|BG001|Baseline|Rapid Organism Identification and AST|Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
11314596|NCT03218397|BG002|Baseline|Total|Total of all reporting groups
11314597|NCT03218397|FG000|Participant Flow|Standard Blood Culture and AST|Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
11314598|NCT03218397|FG001|Participant Flow|Rapid Organism Identification and AST|Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
11314599|NCT03218397|OG000|Outcome|Standard Blood Culture and AST|Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
11314600|NCT03218397|OG001|Outcome|Rapid Organism Identification and AST|Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
11314601|NCT03218397|EG000|Reported Event|Standard Blood Culture and AST|Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
11314602|NCT03218397|EG001|Reported Event|Rapid Organism Identification and AST|Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
11314603|NCT03218566|BG000|Baseline|Single Arm|"Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism~Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism"
11314604|NCT03218566|FG000|Participant Flow|Indigo Aspiration System|"Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism~Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism"
11314605|NCT03218566|OG000|Outcome|Single Arm|"Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism~Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism"
11314606|NCT03218566|EG000|Reported Event|Single Arm|"Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism~Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism"
11314607|NCT03218592|BG000|Baseline|Maraviroc|"12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases~Maraviroc Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314608|NCT03218592|BG001|Baseline|Dolutegravir|"12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases~Dolutegravir Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314609|NCT03218592|BG002|Baseline|Truvada|"12 healthy volunteers will dose with Truvada (TFV/FTC) Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly. Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314610|NCT03218592|BG003|Baseline|Total|Total of all reporting groups
11314611|NCT03218592|FG000|Participant Flow|Maraviroc|"12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases~Maraviroc Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11095047|NCT01556061|BG002|Baseline|Total|Total of all reporting groups
11314612|NCT03218592|FG001|Participant Flow|Dolutegravir|"12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases~Dolutegravir Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314613|NCT03218592|FG002|Participant Flow|Truvada|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314614|NCT03218592|OG000|Outcome|Maraviroc|"12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases~Maraviroc Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314615|NCT03218592|OG001|Outcome|Dolutegravir|"12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases~Dolutegravir Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314616|NCT03218592|OG002|Outcome|Truvada|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly. Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly."
11314617|NCT03218592|OG002|Outcome|Tenfovir (Truvada)|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314618|NCT03218592|OG003|Outcome|Emtricitabine (Truvada)|2nd Component in the combo pill Truvada
11314619|NCT03218592|OG002|Outcome|Tenofovir|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314620|NCT03218592|OG003|Outcome|Emtricitabine|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314621|NCT03218592|OG003|Outcome|Emtricitabine|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly. Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly"
11314622|NCT03218592|EG000|Reported Event|Maraviroc|"12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases~Maraviroc Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly~Adverse Events (AEs) reported for participants across all dose groups as there were none to report."
11314623|NCT03218592|EG001|Reported Event|Dolutegravir|"12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases~Dolutegravir Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly~AEs reported for participants across all dose groups as there were none to report."
11314624|NCT03218592|EG002|Reported Event|Truvada|"12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases~Truvada Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly~AEs reported for participants across all dose groups as there were none to report."
11314625|NCT03218787|BG000|Baseline|XIENCE|"XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month~DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.~Subject who are 3-month clear will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care."
11314626|NCT03218787|FG000|Participant Flow|XIENCE|"XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month~DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.~Subject who are 3-month clear will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care."
11314627|NCT03218787|OG000|Outcome|XIENCE|"XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month~DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.~Subject who are 3-month clear will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care."
11314628|NCT03218787|EG000|Reported Event|XIENCE|"Subjects will receive XIENCE family stent systems and 3-month DAPT~XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month~DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.~Subject who are 3-month clear will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care."
11314629|NCT03219216|BG000|Baseline|Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks|Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
11314630|NCT03219216|BG001|Baseline|Arm B: GLE/PIB for 12 Weeks|Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg once daily (QD) for 12 weeks.
11314631|NCT03219216|BG002|Baseline|Total|Total of all reporting groups
11314632|NCT03219216|FG000|Participant Flow|Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks|Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
11314633|NCT03219216|FG001|Participant Flow|Arm B: GLE/PIB for 12 Weeks|Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.
11314634|NCT03219216|OG000|Outcome|All Participants|Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 or 12 weeks
11314635|NCT03219216|OG000|Outcome|All Participants|GLE/PIB for 8 or 12 weeks
11314636|NCT03219216|EG000|Reported Event|All Participants|All enrolled participants who received at least one dose of study drug.
11314637|NCT03219294|BG000|Baseline|Moderate NMB|"Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice.~Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions."
11314638|NCT03219294|BG001|Baseline|Deep NMB|"Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex.~Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2."
11314639|NCT03219294|BG002|Baseline|Total|Total of all reporting groups
11314640|NCT03219294|FG000|Participant Flow|Moderate NMB|"Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice.~Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions."
11314641|NCT03219294|FG001|Participant Flow|Deep NMB|"Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex.~Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2."
11314642|NCT03219294|OG000|Outcome|Moderate NMB|"Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice.~Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions."
11314643|NCT03219294|OG001|Outcome|Deep NMB|"Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex.~Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2."
10827389|NCT00109590|FG002|Participant Flow|Arm C: LPV/r x 30d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
11314644|NCT03219294|EG000|Reported Event|Moderate NMB|"Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice.~Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions."
11314645|NCT03219294|EG001|Reported Event|Deep NMB|"Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex.~Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2."
11314646|NCT03219320|BG000|Baseline|NYX-2925 200 mg QD|NYX-2925 200 mg PO QD
11314647|NCT03219320|BG001|Baseline|NYX-2025 50 mg QD|NYX-2925 50 mg PO QD
11314648|NCT03219320|BG002|Baseline|NYX-2925 10 mg QD|NYX-2925 10 mg PO QD
11314649|NCT03219320|BG003|Baseline|Placebo QD|Placebo PO QD
11314650|NCT03219320|BG004|Baseline|Total|Total of all reporting groups
11314651|NCT03219320|FG000|Participant Flow|NYX-2925 200 mg Once Daily (QD)|NYX-2925 200 mg PO once daily (QD)
11314652|NCT03219320|FG001|Participant Flow|NYX-2925 50 mg QD|NYX-2925 50 mg PO QD
11314653|NCT03219320|FG002|Participant Flow|NYX-2925 10 mg QD|NYX-2925 10 mg PO QD
11314654|NCT03219320|FG003|Participant Flow|Placebo QD|Placebo PO QD
11314655|NCT03219320|OG000|Outcome|NYX-2925 200 mg QD|NYX-2925 200 mg PO QD
11314656|NCT03219320|OG001|Outcome|NYX-2025 50 mg QD|NYX-2925 50 mg PO QD
11314657|NCT03219320|OG002|Outcome|NYX-2925 10 mg QD|NYX-2925 10 mg PO QD
11314658|NCT03219320|OG003|Outcome|Placebo QD|Placebo PO QD
11314659|NCT03219320|EG000|Reported Event|NYX-2925 200 mg QD|NYX-2925 200 mg PO QD
11314660|NCT03219320|EG001|Reported Event|NYX-2925 50 mg QD|NYX-2925 50 mg PO QD
11314661|NCT03219320|EG002|Reported Event|NYX-2925 10 mg QD|NYX-2925 10 mg PO QD
11314662|NCT03219320|EG003|Reported Event|Placebo QD|Placebo PO QD
11314663|NCT03219723|BG000|Baseline|Vonoprazan 20 mg|For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
11314664|NCT03219723|FG000|Participant Flow|Vonoprazan 20 mg|For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
11314665|NCT03219723|OG000|Outcome|Vonoprazan 20 mg|For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
11314666|NCT03219723|EG000|Reported Event|Vonoprazan 20 mg|For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
11314667|NCT03219840|BG000|Baseline|All Participants|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used during one period of 21 days and Xylitol only chewing gum will be used during another period of 21 days, with the two periods divided by a washout period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
11314668|NCT03219840|FG000|Participant Flow|CPC + Xylitol Chewing Gum, Then Xylitol Only Chewing Gum|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum, and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days.
11314669|NCT03219840|FG001|Participant Flow|Xylitol Only Chewing Gum, Then CPC + Xylitol Chewing Gum|Xylitol only chewing gum, and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days.
11314670|NCT03219840|OG000|Outcome|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
11314671|NCT03219840|OG001|Outcome|Xylitol Only Chewing Gum|Xylitol only chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
11314672|NCT03219840|EG000|Reported Event|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
11314673|NCT03219840|EG001|Reported Event|Xylitol Only Chewing Gum|Xylitol only chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
11314674|NCT03219866|BG000|Baseline|Nebulizers|"Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).~Nebulizers: Patients treated and discharged on nebulized bronchodilators~Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)~Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)~Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)"
11314675|NCT03219866|BG001|Baseline|Dry Powder Inhaler|"Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).~Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers~Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)~Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)"
11314676|NCT03219866|BG002|Baseline|Total|Total of all reporting groups
11314677|NCT03219866|FG000|Participant Flow|Nebulizers|"Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).~Nebulizers: Patients treated and discharged on nebulized bronchodilators~Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)~Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)~Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)"
11314678|NCT03219866|FG001|Participant Flow|Dry Powder Inhaler|"Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).~Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers~Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)~Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)"
11314679|NCT03219866|OG000|Outcome|Nebulizers|"Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).~Nebulizers: Patients treated and discharged on nebulized bronchodilators~Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)~Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)~Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)"
11314680|NCT03219866|OG001|Outcome|Dry Powder Inhaler|"Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).~Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers~Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)~Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)"
11314681|NCT03219866|EG000|Reported Event|Nebulizers|"Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).~Nebulizers: Patients treated and discharged on nebulized bronchodilators~Brovana: Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)~Pulmicort: Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)~Atrovent: Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)"
11314682|NCT03219866|EG001|Reported Event|Dry Powder Inhaler|"Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).~Dry Powder Inhaler: Patients treated and discharged on Dry Powder Inhalers~Advair Diskus: Subjects will receive a LABA/ICS (Advair Diskus, twice daily)~Spiriva HandiHaler: Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)"
11314683|NCT03219892|BG000|Baseline|High-frequency rTMS|"Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA). Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold. A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.~High-frequency rTMS: It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline."
11314684|NCT03219892|BG001|Baseline|Sham rTMS|"Patients randomized to this group will receive the sham rTMS. The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.~Sham rTMS: The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away."
11314685|NCT03219892|BG002|Baseline|Total|Total of all reporting groups
11314686|NCT03219892|FG000|Participant Flow|High-frequency rTMS|"Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA). Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold. A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.~High-frequency rTMS: It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline."
11314687|NCT03219892|FG001|Participant Flow|Sham rTMS|"Patients randomized to this group will receive the sham rTMS. The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.~Sham rTMS: The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away."
11314688|NCT03219892|OG000|Outcome|High-frequency rTMS|"Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA). Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold. A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.~High-frequency rTMS: It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline."
11314689|NCT03219892|OG001|Outcome|Sham rTMS|"Patients randomized to this group will receive the sham rTMS. The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.~Sham rTMS: The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away."
11095048|NCT01556061|FG000|Participant Flow|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
11314690|NCT03219892|EG000|Reported Event|High-frequency rTMS|"Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA). Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold. A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.~High-frequency rTMS: It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline."
11314691|NCT03219892|EG001|Reported Event|Sham rTMS|"Patients randomized to this group will receive the sham rTMS. The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.~Sham rTMS: The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away."
11314692|NCT03220048|BG000|Baseline|Cohort A: Sentinel Group|Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
11314693|NCT03220048|BG001|Baseline|Cohort B: PrEP-001|PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314694|NCT03220048|BG002|Baseline|Cohort B: Placebo|Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314695|NCT03220048|BG003|Baseline|Total|Total of all reporting groups
11314696|NCT03220048|FG000|Participant Flow|Cohort A: Sentinel Group|Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
11314697|NCT03220048|FG001|Participant Flow|Cohort B: PrEP-001|PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314698|NCT03220048|FG002|Participant Flow|Cohort B: Placebo|Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314699|NCT03220048|OG000|Outcome|Cohort A: Sentinel Group|"Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.~Placebo Comparator"
11314700|NCT03220048|OG001|Outcome|Cohort B: PrEP-001|"PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, or Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.~PrEP-001"
11314701|NCT03220048|OG002|Outcome|Cohort B: Placebo|Placebo Comparator
11314702|NCT03220048|OG001|Outcome|Cohort B: PrEP-001|"PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.~PrEP-001"
11314703|NCT03220048|OG002|Outcome|Cohort B: Placebo|"Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.~Placebo Comparator"
11314704|NCT03220048|OG000|Outcome|Cohort A: Sentinel Group|Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
11314705|NCT03220048|OG001|Outcome|Cohort B: PrEP-001|PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314706|NCT03220048|OG002|Outcome|Cohort B: Placebo|Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314707|NCT03220048|EG000|Reported Event|Cohort A: Sentinel Group|Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
11314708|NCT03220048|EG001|Reported Event|Cohort B: PrEP-001|PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314709|NCT03220048|EG002|Reported Event|Cohort B: Placebo|Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
11314710|NCT03220204|BG000|Baseline|PP-based Health Behavior Intervention|"Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."
11314711|NCT03220204|BG001|Baseline|MI-based Educational Control Condition|"Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.~Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management."
11314712|NCT03220204|BG002|Baseline|Treatment as Usual (TAU)|Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
11314713|NCT03220204|BG003|Baseline|Total|Total of all reporting groups
11095049|NCT01556061|FG001|Participant Flow|D-MAC First, Then CMAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
11314714|NCT03220204|FG000|Participant Flow|PP-based Health Behavior Intervention|"Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."
11314715|NCT03220204|FG001|Participant Flow|MI-based Educational Control Condition|"Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.~Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management."
11314716|NCT03220204|FG002|Participant Flow|Treatment as Usual (TAU)|Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
11314717|NCT03220204|OG000|Outcome|PP-based Health Behavior Intervention|"Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."
11314718|NCT03220204|OG000|Outcome|PP-based Health Behavior Intervention|"Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."
11314719|NCT03220204|OG001|Outcome|MI-based Educational Control Condition|"Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.~Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management."
11314720|NCT03220204|OG002|Outcome|Treatment as Usual (TAU)|Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
11314721|NCT03220204|OG001|Outcome|MI-based Educational Control Condition|"Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.~MI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management."
11314722|NCT03220204|OG002|Outcome|Treatment as Usual (TAU)|Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.
11314723|NCT03220204|EG000|Reported Event|PP-based Health Behavior Intervention|"Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.~PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence."
11314724|NCT03220204|EG001|Reported Event|MI-based Educational Control Condition|"Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.~MI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management."
11095050|NCT01556061|OG000|Outcome|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
11314725|NCT03220204|EG002|Reported Event|Treatment as Usual (TAU)|Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.
11314726|NCT03220217|BG000|Baseline|Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq|"Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 40-80 MBq on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.~Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)."
11314727|NCT03220217|BG001|Baseline|Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq|"Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.~Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)."
11314728|NCT03220217|BG002|Baseline|Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq|"Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq.~Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)."
11314729|NCT03220217|BG003|Baseline|Total|Total of all reporting groups
11314730|NCT03220217|FG000|Participant Flow|Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq|"Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq.~Both injections were followed by positron emission tomography(PET)/computed tomography (CT) scan imaging 1 hour post dosing (up to 80 min)."
11314731|NCT03220217|FG001|Participant Flow|Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq|"Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq.~Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)."
11314732|NCT03220217|FG002|Participant Flow|Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq|"Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1).~After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq.~Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)."
11314733|NCT03220217|OG000|Outcome|Arm A: 5-20 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.
11314734|NCT03220217|OG001|Outcome|Arm A: 30-45 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.
11314735|NCT03220217|OG002|Outcome|Arm B: 5-20 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.
11314736|NCT03220217|OG003|Outcome|Arm B: 30-45 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.
11314737|NCT03220217|OG004|Outcome|Arm C: 5-20 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.
11314738|NCT03220217|OG005|Outcome|Arm C: 30-45 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.
11314739|NCT03220217|OG000|Outcome|Peptide Mass Dose Range 5-20 μg|Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).
11314740|NCT03220217|OG001|Outcome|Peptide Mass Dose Range 30-45 μg|Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).
11314741|NCT03220217|OG002|Outcome|Radioactivity Dose Range 40-80 MBq|Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
11314742|NCT03220217|OG003|Outcome|Radioactivity Dose Range 100-140 MBq|Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
11314743|NCT03220217|OG004|Outcome|Radioactivity Dose Range 160-200 MBq|Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
11314744|NCT03220217|OG000|Outcome|Arm A: 5-20 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
11314745|NCT03220217|OG001|Outcome|Arm A: 30-45 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
11314746|NCT03220217|OG002|Outcome|Arm B: 5-20 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
11314747|NCT03220217|OG003|Outcome|Arm B: 30-45 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
11314748|NCT03220217|OG004|Outcome|Arm C: 5-20 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
11314749|NCT03220217|OG005|Outcome|Arm C: 30-45 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
11314750|NCT03220217|OG000|Outcome|Radioactivity Dose Range 40-80 MBq|Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
11314751|NCT03220217|OG001|Outcome|Radioactivity Dose Range 100-140 MBq|Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2(Day 1) or on Visit 3 (Days 16-22).
11314752|NCT03220217|OG002|Outcome|Radioactivity Dose Range 160-200 MBq|Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).
11314753|NCT03220217|EG000|Reported Event|Arm A: 5-20 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2 (Day 1).
11314754|NCT03220217|EG001|Reported Event|Arm A: 30-45 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3 (Days 16 to 22).
11314755|NCT03220217|EG002|Reported Event|Arm B: 5-20 μg/100-140 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2 (Day 1).
11314756|NCT03220217|EG003|Reported Event|Arm B: 30-45 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3 (Days 16 to 22).
11095051|NCT01556061|OG001|Outcome|D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
11314757|NCT03220217|EG004|Reported Event|Arm C: 5-20 μg/160-200 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity range of 160-200 MBq.
11314758|NCT03220217|EG005|Reported Event|Arm C: 30-45 μg/40-80 MBq|Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3 (Days 16 to 22).
11314759|NCT03220217|EG006|Reported Event|Overall|Total number of AEs experienced across all Arms.
11314760|NCT03220230|BG000|Baseline|Non-Small Cell Lung Cancer Participants|Tissue and blood samples of participants with NSCLC were collected and analyzed to validate new molecular diagnostic technologies (such as NGS) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
11314761|NCT03220230|FG000|Participant Flow|Non-Small Cell Lung Cancer Participants|Tissue and blood samples of participants with non-small cell lung cancer (NSCLC) were collected and analyzed to validate new molecular diagnostic technologies (such as Next Generation Sequencing [NGS]) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
11314762|NCT03220230|OG000|Outcome|Non-Small Cell Lung Cancer Participants|Tissue and blood samples of participants with NSCLC were collected and analyzed to validate new molecular diagnostic technologies (such as NGS) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
11314763|NCT03220230|EG000|Reported Event|Non-Small Cell Lung Cancer Participants|Tissue and blood samples of participants with NSCLC were collected and analyzed to validate new molecular diagnostic technologies (such as NGS) and to compare their performance with the available standard tests. Participants were not treated or affected and only participated in the study for the initial samples and clinical parameters collection.
11314764|NCT03220412|BG000|Baseline|Experimental Condition|"Participants in this condition viewed a movie without guns. The movie (National Treasure or The Rocketeer) was edited to remove guns from scenes.~Movies without Guns: Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes"
11314765|NCT03220412|BG001|Baseline|Control Condition|Participants in this condition viewed a movie with guns, as it was filmed and distributed. The actual scenes in the movie (National Treasure or The Rocketeer) was not edited, but the same scenes were used as the Experimental Condition
11314766|NCT03220412|BG002|Baseline|Total|Total of all reporting groups
11314767|NCT03220412|FG000|Participant Flow|Experimental Condition|"Participants in this condition viewed a movie without guns. The movie (National Treasure or The Rocketeer) was edited to remove guns from scenes.~Movies without Guns: Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes"
11314768|NCT03220412|FG001|Participant Flow|Control Condition|Participants in this condition viewed a movie with guns, as it was filmed and distributed. The actual scenes in the movie (National Treasure or The Rocketeer) was not edited, but the same scenes were used as the Experimental Condition
11314769|NCT03220412|OG000|Outcome|Experimental Condition|Participants in this condition watched movies as they were released, with guns.
11314770|NCT03220412|OG001|Outcome|Control|Participants in this condition watched the same movie and same scenes with guns edited out of the scenes.
11314771|NCT03220412|OG000|Outcome|Experimental Condition|"Participants in this condition viewed a movie without guns. The movie (National Treasure or The Rocketeer) was edited to remove guns from scenes.~Movies without Guns: Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes"
11314772|NCT03220412|OG001|Outcome|Control Condition|Participants in this condition viewed a movie with guns, as it was filmed and distributed. The actual scenes in the movie (National Treasure or The Rocketeer) was not edited, but the same scenes were used as the Experimental Condition
11314773|NCT03220412|EG000|Reported Event|Experimental Condition|"Participants in this condition viewed a movie without guns. The movie (National Treasure or The Rocketeer) was edited to remove guns from scenes.~Movies without Guns: Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes"
11314774|NCT03220412|EG001|Reported Event|Control Condition|Participants in this condition viewed a movie with guns, as it was filmed and distributed. The actual scenes in the movie (National Treasure or The Rocketeer) was not edited, but the same scenes were used as the Experimental Condition
11314775|NCT03220737|BG000|Baseline|Cohort 1 (Active, 12-17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314776|NCT03220737|BG001|Baseline|Cohort 1 (Placebo, 12 - 17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314777|NCT03220737|BG002|Baseline|Cohort 2 (Active, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314778|NCT03220737|BG003|Baseline|Cohort 2 (Placebo, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314779|NCT03220737|BG004|Baseline|Cohort 3 (Active, 2 - 5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314780|NCT03220737|BG005|Baseline|Cohort 3 (Placebo, 2 - 5 Yrs)|"Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314781|NCT03220737|BG006|Baseline|Historical Control: Adult Bridging Population|This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118
11314782|NCT03220737|BG007|Baseline|Total|Total of all reporting groups
11314783|NCT03220737|FG000|Participant Flow|Cohort 1 (Active, 12-17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314784|NCT03220737|FG001|Participant Flow|Cohort 1 (Placebo, 12 - 17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314785|NCT03220737|FG002|Participant Flow|Cohort 2 (Active, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314786|NCT03220737|FG003|Participant Flow|Cohort 2 (Placebo, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314787|NCT03220737|FG004|Participant Flow|Cohort 3 (Active, 2 - 5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314788|NCT03220737|FG005|Participant Flow|Cohort 3 (Placebo, 2 - 5 Yrs)|"Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314789|NCT03220737|FG006|Participant Flow|Historical Control: Adult Bridging Population|This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
11314790|NCT03220737|OG000|Outcome|Cohort 1 (Active, 12-17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314791|NCT03220737|OG001|Outcome|Cohort 1 (Placebo, 12-17 Yrs)|Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
11314792|NCT03220737|OG000|Outcome|Cohort 2 (Active, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314793|NCT03220737|OG001|Outcome|Cohort 2 (Placebo, 6-11 Yrs)|Subjects aged 6 - 11 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
11314794|NCT03220737|OG000|Outcome|Cohort 3 (Active, 2 - 5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314795|NCT03220737|OG001|Outcome|Cohort 3 (Placebo, 2-5 Yrs)|Subjects aged 2 - 5 were administered a 50 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
11314796|NCT03220737|OG001|Outcome|Historical Control: Adult Bridging Population|This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion.
11314797|NCT03220737|OG000|Outcome|Cohort 2 (Active, 6-11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314798|NCT03220737|OG000|Outcome|Cohort 3 (Active, 2-5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314799|NCT03220737|OG001|Outcome|Cohort 1 (Placebo, 12 - 17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314800|NCT03220737|OG002|Outcome|Cohort 2 (Active, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314801|NCT03220737|OG003|Outcome|Cohort 2 (Placebo, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314802|NCT03220737|OG004|Outcome|Cohort 3 (Active, 2 - 5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314803|NCT03220737|OG005|Outcome|Cohort 3 (Placebo, 2 - 5 Yrs)|"Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314804|NCT03220737|EG000|Reported Event|Cohort 1 (Active, 12-17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314805|NCT03220737|EG001|Reported Event|Cohort 1 (Placebo, 12 - 17 Yrs)|"Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314806|NCT03220737|EG002|Reported Event|Cohort 2 (Active, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314807|NCT03220737|EG003|Reported Event|Cohort 2 (Placebo, 6 - 11 Yrs)|"Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314808|NCT03220737|EG004|Reported Event|Cohort 3 (Active, 2 - 5 Yrs)|"Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.~VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR."
11314809|NCT03220737|EG005|Reported Event|Cohort 3 (Placebo, 2 - 5 Yrs)|"Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.~Placebo: Placebo control for this study is normal (0.9%) saline."
11314810|NCT03220958|BG000|Baseline|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip~Metoclopramide: Metoclopramide 20mg~Diphenhydramine: Diphenhydramine 25mg~Normal saline: 100ml normal saline"
10827390|NCT00109590|OG000|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
11314811|NCT03220958|BG001|Baseline|Placebo|"Normal saline, administered as an intravenous drip~Normal saline: 100ml normal saline"
11314812|NCT03220958|BG002|Baseline|Total|Total of all reporting groups
11314813|NCT03220958|FG000|Participant Flow|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip~Metoclopramide: Metoclopramide 20mg~Diphenhydramine: Diphenhydramine 25mg~Normal saline: 100ml normal saline"
11314814|NCT03220958|FG001|Participant Flow|Placebo|"Normal saline, administered as an intravenous drip~Normal saline: 100ml normal saline"
11314815|NCT03220958|OG000|Outcome|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip~Metoclopramide: Metoclopramide 20mg~Diphenhydramine: Diphenhydramine 25mg~Normal saline: 100ml normal saline"
11314816|NCT03220958|OG001|Outcome|Placebo|"Normal saline, administered as an intravenous drip~Normal saline: 100ml normal saline"
11314817|NCT03220958|EG000|Reported Event|Metoclopramide|"Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip~Metoclopramide: Metoclopramide 20mg~Diphenhydramine: Diphenhydramine 25mg~Normal saline: 100ml normal saline"
11314818|NCT03220958|EG001|Reported Event|Placebo|"Normal saline, administered as an intravenous drip~Normal saline: 100ml normal saline"
11314819|NCT03221192|BG000|Baseline|Interview Participants With Nasal Polyps|Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
11314820|NCT03221192|FG000|Participant Flow|Interview Participants With Nasal Polyps|Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
11314821|NCT03221192|OG000|Outcome|Interview Participants With Nasal Polyps|Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
11314822|NCT03221192|EG000|Reported Event|Interview Participants With Nasal Polyps|Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
11314823|NCT03221387|BG000|Baseline|Nasal High Flow With Oxygen|"While in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting.~Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases."
11314824|NCT03221387|FG000|Participant Flow|Nasal High Flow With Oxygen|"While in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting.~Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases."
11314825|NCT03221387|OG000|Outcome|Nasal High Flow With Oxygen|"While in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting.~Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases."
11314826|NCT03221387|EG000|Reported Event|Nasal High Flow With Oxygen|"While in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting.~Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases."
11314827|NCT03221595|BG000|Baseline|Operative|"Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.~Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints"
11314828|NCT03221595|BG001|Baseline|Non-Operative|Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
11314829|NCT03221595|BG002|Baseline|Total|Total of all reporting groups
11314830|NCT03221595|FG000|Participant Flow|Operative|"Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.~Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints"
11314831|NCT03221595|FG001|Participant Flow|Non-Operative|Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
11314832|NCT03221595|OG000|Outcome|Operative|"Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.~Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints"
11314833|NCT03221595|OG001|Outcome|Non-operative|Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
11314834|NCT03221595|EG000|Reported Event|Operative|"Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.~Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints"
11314835|NCT03221595|EG001|Reported Event|Non-operative|Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
11314836|NCT03221738|BG000|Baseline|App-Based Cognitive Behavioral Therapy|"12-week Smartphone-delivered CBT for BDD.~App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills."
11314837|NCT03221738|FG000|Participant Flow|App-Based Cognitive Behavioral Therapy|"12-week Smartphone-delivered CBT for BDD.~App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills."
11314838|NCT03221738|OG000|Outcome|App-Based Cognitive Behavioral Therapy|"12-week Smartphone-delivered CBT for BDD.~App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills."
11314839|NCT03221738|EG000|Reported Event|App-Based Cognitive Behavioral Therapy|"12-week Smartphone-delivered CBT for BDD.~App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills."
11314840|NCT03221764|BG000|Baseline|Study Group|Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
11314841|NCT03221764|FG000|Participant Flow|Study Group|Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
11314842|NCT03221764|OG000|Outcome|Study Group|Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
11314843|NCT03221764|EG000|Reported Event|Study Group|Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
11314844|NCT03222037|BG000|Baseline|Total Dispensed|All subjects dispensed at least one study treatment.
11314845|NCT03222037|FG000|Participant Flow|Test/SCR|Subjects that were randomized to receive the Test lens during the first period and then the SCR (Subjective Spherorcylindrical Refraction) treatment during the second period.
11314846|NCT03222037|FG001|Participant Flow|SCR/Test|Subjects that were randomized to receive the SCR (Subjective Spherorcylindrical Refraction) treatment during the first period and then the Test lens during the second period.
11314847|NCT03222037|OG000|Outcome|Test|Subjects that received the Test lens during either the first or second period of the study.
11314848|NCT03222037|OG001|Outcome|SCR (Subjective Spherorcylindrical Refraction)|Subjects that received the SCR treatment during either the first or second period of the study.
11314849|NCT03222037|EG000|Reported Event|Test|Subjects that received the Test lens during either the first or second period of the study.
11314850|NCT03222037|EG001|Reported Event|SCR (Subjective Spherorcylindrical Refraction)|Subjects that received the SCR treatment during either the first or second period of the study.
11314851|NCT03222141|BG000|Baseline|SAPIEN 3™ Valve|TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
11314852|NCT03222141|FG000|Participant Flow|SAPIEN 3™ Valve|TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
11314853|NCT03222141|OG000|Outcome|SAPIEN 3™ Valve|TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
11314854|NCT03222141|OG000|Outcome|SAPIEN 3™ THV|TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
11314855|NCT03222141|EG000|Reported Event|SAPIEN 3™ THV|"TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation.~High risk cohort"
11314856|NCT03222349|BG000|Baseline|Safety Analysis Set|A total of 24 subjects were enrolled and received at least 1 dose of DBF determined based on age and weight (6 in the 2-5 years age group, 9 in the 6-11 years age group, and 9 in the 12-16 years age group).
11314857|NCT03222349|FG000|Participant Flow|Interictal State, Then Ictal/Peri-ictal State|The interictal state was defined as a period of time during which 3 hours had elapsed since any clinical postictal signs or symptoms (from the last observed seizure). If clinical and/or electroencephalogram monitoring showed no seizure activity, the subject received DBF single dose determined by age and body weight.
11314858|NCT03222349|FG001|Participant Flow|Ictal/Peri-ictal State, Then Interictal State|The ictal/peri-ictal state was defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The peri-ictal state was defined as the subject's immediate postictal state following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness, and within 5 minutes after the last clonic jerk. For subjects on EEG monitoring, the peri-ictal state could be defined as less than 5 minutes after cessation of seizure activity (GTC or focal seizure with impaired awareness) as verified via EEG.
11314859|NCT03222349|OG000|Outcome|Interictal State|"Diazepam Buccal Film administered to epileptic patients during interictal state (Period A).~Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period."
11314860|NCT03222349|OG001|Outcome|Ictal/Peri-ictal State|Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
11314861|NCT03222349|OG000|Outcome|Interictal State (Period A)|Diazepam Buccal Film administered to epileptic patients during interictal state (Period A) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
11314862|NCT03222349|OG001|Outcome|Ictal/Peri-ictal State (Period B)|Diazepam Buccal Film administered to epileptic patients during ictal/peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
11314863|NCT03222349|OG000|Outcome|Interictal State (Period A)|Diazepam Buccal Film administered to epileptic patients during Interictal state (Period A) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
10827391|NCT00109590|OG001|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
10827392|NCT00109590|OG002|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827393|NCT00109590|OG000|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
10827394|NCT00109590|OG001|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
10827395|NCT00109590|OG002|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827396|NCT00109590|OG000|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
10827397|NCT00109590|OG001|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
10827398|NCT00109590|OG000|Outcome|Arm A: LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
10827399|NCT00109590|OG001|Outcome|Arm B: no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
10827400|NCT00109590|OG002|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827401|NCT00109590|OG002|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827402|NCT00109590|OG002|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
10827403|NCT00109590|OG000|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
10827404|NCT00109590|EG000|Reported Event|Mother: LPV/r x 7d|NVP 200 mg orally, single dose at onset
10827405|NCT00109590|EG001|Reported Event|Mother: no LPV/r|ZDV & ddI x 30d
10827406|NCT00109590|EG002|Reported Event|Mother: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
10827407|NCT00109590|EG003|Reported Event|Infant: LPV/r x 7d|NVP 200 mg orally, single dose at onset
10827408|NCT00109590|EG004|Reported Event|Infant: no LPV/r|ZDV & ddI x 30d
10827409|NCT00109590|EG005|Reported Event|Infant: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
10827410|NCT00109707|BG000|Baseline|CML-CP With Prior Imatinib Only|Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827411|NCT00109707|BG001|Baseline|CML-AP With Prior Imatinib Only|Adult participants PH+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827412|NCT00109707|BG002|Baseline|CML-CP|Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827413|NCT00109707|BG003|Baseline|Total|Total of all reporting groups
10827414|NCT00109707|FG000|Participant Flow|CML-CP With Prior Imatinib Only|Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827415|NCT00109707|FG001|Participant Flow|CML-AP With Prior Imatinib Only|Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827416|NCT00109707|FG002|Participant Flow|CML-CP|Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
11314864|NCT03222349|OG000|Outcome|Interictal Period (Period A)|"Each subject received a single dose of DBF based on the subject's age and weight.~Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses."
11314865|NCT03222349|OG001|Outcome|Ictal/Peri-Ictal Period (Period B)|"Each subject received a single dose of DBF based on the subject's age and weight.~Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses."
11314866|NCT03222349|OG001|Outcome|Ictal/Peri-ictal Period (Period B)|"Each subject received a single dose of DBF based on the subject's age and weight.~Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses."
11314867|NCT03222349|OG001|Outcome|Ictal/Peri-ictal State|Diazepam Buccal Film administered to epileptic patients during ictal-peri-ictal state (Period B) Subjects received a single dose of DBF (range 5 to 17.5 mg) determined on the basis of the subject's age and weight using an interactive web response system during check-in for the subject's first treatment period.
11314868|NCT03222349|EG000|Reported Event|Interictal Period (Period A)|"Each subject received a single dose of DBF based on the subject's age and weight.~Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses."
11314869|NCT03222349|EG001|Reported Event|Ictal/Peri-ictal Period (Period B)|"Each subject received a single dose of DBF based on the subject's age and weight.~Diazepam Buccal Film: Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses."
11314870|NCT03222414|BG000|Baseline|Arm A: Conical Then Cylindrical|"BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314871|NCT03222414|BG001|Baseline|Arm B: Cylindrical Then Conical|"BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314872|NCT03222414|BG002|Baseline|Total|Total of all reporting groups
11314873|NCT03222414|FG000|Participant Flow|Arm A: Conical Then Cylindrical|"BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314874|NCT03222414|FG001|Participant Flow|Arm B: Cylindrical Then Conical|"BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314875|NCT03222414|OG000|Outcome|Conical|"BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314876|NCT03222414|OG001|Outcome|Cylindrical|"Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314877|NCT03222414|EG000|Reported Event|Arm A: Conical Then Cylindrical|"BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314878|NCT03222414|EG001|Reported Event|Arm B: Cylindrical Then Conical|"BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring~Non-invasive BP recording with conical Ultracheck Curve BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff~Non-invasive BP recording with traditional cylindrical BP cuff: Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff~Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements"
11314879|NCT03222427|BG000|Baseline|LY3314814 + [13C415N3] LY3314814|Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1.
11314880|NCT03222427|FG000|Participant Flow|LY3314814 + [13C415N3] LY3314814|Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1.
11314881|NCT03222427|OG000|Outcome|LY3314814|Single 50 mg dose of LY3314814 administered orally.
11314882|NCT03222427|OG001|Outcome|[13C415N3] LY3314814|Single 100 μg IV dose of [13C415N3] LY3314814 administered as an IV infusion.
11314883|NCT03222427|EG000|Reported Event|LY3314814 + [13C415N3] LY3314814|Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1.
11314884|NCT03222505|BG000|Baseline|Start With Device ON|Participants in this arm first completed testing with the device on, then repeated the testing a week later with the device turned off.
11314885|NCT03222505|BG001|Baseline|Start With Device OFF|Participants in this arm first completed testing with the device off, then repeated the testing a week later with the device turned on.
11314886|NCT03222505|BG002|Baseline|Total|Total of all reporting groups
11314887|NCT03222505|FG000|Participant Flow|Start With Device ON|Participants in this arm first completed testing with the device on, then repeated the testing a week later with the device turned off.
11314888|NCT03222505|FG001|Participant Flow|Start With Device OFF|Participants in this arm first completed testing with the device off, then repeated the testing a week later with the device turned on.
11314889|NCT03222505|OG000|Outcome|Device ON|Data collected from while the device was turned on.
11314890|NCT03222505|OG001|Outcome|Device OFF|Data collected from while the device was turned off.
11314891|NCT03222505|OG000|Outcome|Difference Between Device ON and Device OFF|Difference in excitability for device on and off.
11314892|NCT03222505|EG000|Reported Event|Device ON|The arm reflects time during study participation when the participants were wearing the device.
11314893|NCT03222505|EG001|Reported Event|Device OFF|The arm reflects time during study participation when the participants were not wearing the device.
11314894|NCT03222583|BG000|Baseline|Arm A: Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.
11314895|NCT03222583|BG001|Baseline|Arm B: Placebo / Glecaprevir/Pibrentasvir|Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.
11314896|NCT03222583|BG002|Baseline|Total|Total of all reporting groups
11314897|NCT03222583|FG000|Participant Flow|Arm A: Glecaprevir/Pibrentasvir|"Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.~Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks."
11314898|NCT03222583|FG001|Participant Flow|Arm B: Placebo / Glecaprevir/Pibrentasvir|"Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.~In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks."
11314899|NCT03222583|OG000|Outcome|Arm A: Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.
11314900|NCT03222583|EG000|Reported Event|DB Period: Arm A - Glecaprevir/Pibrentasvir|"Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.~Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks."
11314901|NCT03222583|EG001|Reported Event|DB Period: Arm B - Placebo|"Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period.~Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks."
11314902|NCT03222583|EG002|Reported Event|OL Period: Arm B - Glecaprevir/Pibrentasvir|"Participants randomized to receive placebo in the DB treatment period received glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.~Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks."
11314903|NCT03223246|BG000|Baseline|Usual Care|Standard discharge care
11314904|NCT03223246|BG001|Baseline|Additional Teaching|Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
11314905|NCT03223246|BG002|Baseline|Total|Total of all reporting groups
11314906|NCT03223246|FG000|Participant Flow|Usual Care|Standard discharge care
11314907|NCT03223246|FG001|Participant Flow|Additional Teaching|Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
11314908|NCT03223246|OG000|Outcome|Usual Care|Standard discharge care
11314909|NCT03223246|OG001|Outcome|Additional Teaching|Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
11314910|NCT03223246|EG000|Reported Event|Usual Care|Standard discharge care
11314911|NCT03223246|EG001|Reported Event|Additional Teaching|Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
11314912|NCT03223272|BG000|Baseline|Reserpine|"Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.~Reserpine: Open label reserpine 0.1 mg pill orally"
11314913|NCT03223272|FG000|Participant Flow|Reserpine|"Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.~Reserpine: Open label reserpine 0.1 mg pill orally"
11314914|NCT03223272|OG000|Outcome|Reserpine|"Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.~Reserpine: Open label reserpine 0.1 mg pill orally"
11314915|NCT03223272|EG000|Reported Event|Reserpine|"Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.~Reserpine: Open label reserpine 0.1 mg pill orally"
11314916|NCT03223337|BG000|Baseline|Part 1: Moderate Hepatic Impairment Participants|Participants with moderate hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during Part 1 of the study. This group included at least one participant with a Child-Pugh score of 7, 8 and 9 for moderate hepatic impairment.
11314917|NCT03223337|BG001|Baseline|Part 1: Healthy Participants|Healthy control participants, matched to moderate hepatic impairment participants in gender, age and Body mass index (BMI) received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state.
11314918|NCT03223337|BG002|Baseline|Part 2: Mild Hepatic Impairment Participants|Participants with mild hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during part 2 of the study. This group included at least one participant with a Child-Pugh score of 5 and 6 for mild hepatic impairment.
11314919|NCT03223337|BG003|Baseline|Part 2: Healthy Participants|Healthy control participants, matched to mild hepatic impairment participants in gender, age and BMI received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state in part 2 of the study.
11314920|NCT03223337|BG004|Baseline|Total|Total of all reporting groups
11314921|NCT03223337|FG000|Participant Flow|Part 1: Moderate Hepatic Impairment Participants|Participants with moderate hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during Part 1 of the study. This group included at least one participant with a Child-Pugh score of 7, 8 and 9 for moderate hepatic impairment.
11314922|NCT03223337|FG001|Participant Flow|Part 1: Healthy Participants|Healthy control participants, matched to moderate hepatic impairment participants in gender, age and Body mass index (BMI) received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state.
11314923|NCT03223337|FG002|Participant Flow|Part 2: Mild Hepatic Impairment Participants|Participants with mild hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during part 2 of the study. This group included at least one participant with a Child-Pugh score of 5 and 6 for mild hepatic impairment.
11314924|NCT03223337|FG003|Participant Flow|Part 2: Healthy Participants|Healthy control participants, matched to mild hepatic impairment participants in gender, age and BMI received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state in part 2 of the study.
11314925|NCT03223337|OG000|Outcome|Part 1: Moderate Hepatic Impairment Participants|Participants with moderate hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during Part 1 of the study. This group included at least one participant with a Child-Pugh score of 7, 8 and 9 for moderate hepatic impairment.
11314926|NCT03223337|OG001|Outcome|Part 1: Healthy Participants|Healthy control participants, matched to moderate hepatic impairment participants in gender, age and Body mass index (BMI) received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state.
11314927|NCT03223337|OG000|Outcome|Part 2: Mild Hepatic Impairment Participants|Participants with mild hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during part 2 of the study. This group included at least one participant with a Child-Pugh score of 5 and 6 for mild hepatic impairment.
11314928|NCT03223337|OG001|Outcome|Part 2: Healthy Participants|Healthy control participants, matched to mild hepatic impairment participants in gender, age and BMI received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state in part 2 of the study.
11314929|NCT03223337|EG000|Reported Event|Part 1: Moderate Hepatic Impairment Participants|Participants with moderate hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during Part 1 of the study. This group included at least one participant with a Child-Pugh score of 7, 8 and 9 for moderate hepatic impairment.
11314930|NCT03223337|EG001|Reported Event|Part 1: Healthy Participants|Healthy control participants, matched to moderate hepatic impairment participants in gender, age and Body mass index (BMI) received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state.
11314931|NCT03223337|EG002|Reported Event|Part 2: Mild Hepatic Impairment Participants|Participants with mild hepatic impairment received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state during part 2 of the study. This group included at least one participant with a Child-Pugh score of 5 and 6 for mild hepatic impairment.
11314932|NCT03223337|EG003|Reported Event|Part 2: Healthy Participants|Healthy control participants, matched to mild hepatic impairment participants in gender, age and BMI received 6 mg of GSK1278863 as a single oral dose tablet in the fasted state in part 2 of the study.
11314933|NCT03223649|BG000|Baseline|Sedentary|"(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.~Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration."
11314934|NCT03223649|BG001|Baseline|Walking Bouts|"Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test.~Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test."
11314935|NCT03223649|BG002|Baseline|Total|Total of all reporting groups
11314936|NCT03223649|FG000|Participant Flow|Sedentary|"(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.~Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration."
11314937|NCT03223649|FG001|Participant Flow|Walking Bouts|"Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test.~Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test."
11314938|NCT03223649|OG000|Outcome|Sedentary|"(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.~Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration."
11314939|NCT03223649|OG001|Outcome|Walking Bouts|"Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test.~Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test."
11314940|NCT03223649|EG000|Reported Event|Sedentary|"(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.~Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration."
11314941|NCT03223649|EG001|Reported Event|Walking Bouts|"Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test.~Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test."
11314942|NCT03223909|BG000|Baseline|PRO-087 PF|"Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.~PRO-087: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate"
11314943|NCT03223909|BG001|Baseline|Systane Ultra|"Systane Ultra ophthalmic solution, Dropper bottle, Multidose.~1 drop every 4 hours for 90 days.~Systane Ultra: Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative."
11314944|NCT03223909|BG002|Baseline|Systane Ultra PF|"Systane Ultra, preservative free ophthalmic solution, single-use vials.~1 drop every 4 hours for 90 days.~Systane Ultra Preservative Free: Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,"
11314945|NCT03223909|BG003|Baseline|Total|Total of all reporting groups
11314946|NCT03223909|FG000|Participant Flow|PRO-087 PF|"Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.~PRO-087: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate"
10827417|NCT00109707|OG000|Outcome|CML-CP With Prior Imatinib Only|Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
11314947|NCT03223909|FG001|Participant Flow|Systane Ultra|"Systane Ultra ophthalmic solution, Dropper bottle, Multidose.~1 drop every 4 hours for 90 days.~Systane Ultra: Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative."
11314948|NCT03223909|FG002|Participant Flow|Systane Ultra PF|"Systane Ultra, preservative free ophthalmic solution, single-use vials.~1 drop every 4 hours for 90 days.~Systane Ultra Preservative Free: Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,"
11314949|NCT03223909|OG000|Outcome|PRO-087 PF|"Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.~PRO-087: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate"
11314950|NCT03223909|OG001|Outcome|Systane Ultra|"Systane Ultra ophthalmic solution, Dropper bottle, Multidose.~1 drop every 4 hours for 90 days.~Systane Ultra: Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative."
11314951|NCT03223909|OG002|Outcome|Systane Ultra PF|"Systane Ultra, preservative free ophthalmic solution, single-use vials.~1 drop every 4 hours for 90 days.~Systane Ultra Preservative Free: Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,"
11314952|NCT03223909|EG000|Reported Event|PRO-087 PF|"Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.~PRO-087: 0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate"
11314953|NCT03223909|EG001|Reported Event|Systane Ultra|"Systane Ultra ophthalmic solution, Dropper bottle, Multidose.~1 drop every 4 hours for 90 days.~Systane Ultra: Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative."
11314954|NCT03223909|EG002|Reported Event|Systane Ultra PF|"Systane Ultra, preservative free ophthalmic solution, single-use vials.~1 drop every 4 hours for 90 days.~Systane Ultra Preservative Free: Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,"
11314955|NCT03224130|BG000|Baseline|Nurse Phone Call|"Families in this arm will receive a phone call within 96 hours of discharge~Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home"
11314956|NCT03224130|BG001|Baseline|Standard of Care|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11314957|NCT03224130|BG002|Baseline|Total|Total of all reporting groups
11314958|NCT03224130|FG000|Participant Flow|Nurse Phone Call|"Families in this arm will receive a phone call within 96 hours of discharge~Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home"
11314959|NCT03224130|FG001|Participant Flow|Standard of Care|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11314960|NCT03224130|OG000|Outcome|Nurse Phone Call|"Families in this arm will receive a phone call within 96 hours of discharge~Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home"
11314961|NCT03224130|OG001|Outcome|Standard of Care|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11314962|NCT03224130|EG000|Reported Event|Nurse Phone Call|"Families in this arm will receive a phone call within 96 hours of discharge~Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home"
11314963|NCT03224130|EG001|Reported Event|Standard of Care|"This arm will receive standard of care.~Standard of Care: Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside."
11314964|NCT03224182|BG000|Baseline|Qapzola|Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314965|NCT03224182|BG001|Baseline|Placebo|Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314966|NCT03224182|BG002|Baseline|Total|Total of all reporting groups
11314967|NCT03224182|FG000|Participant Flow|Qapzola|Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314968|NCT03224182|FG001|Participant Flow|Placebo|Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314969|NCT03224182|OG000|Outcome|Qapzola|Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314970|NCT03224182|OG001|Outcome|Placebo|Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314971|NCT03224182|EG000|Reported Event|Qapzola|Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314972|NCT03224182|EG001|Reported Event|Placebo|Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
11314973|NCT03224234|BG000|Baseline|Insulclock With Feedback (Group A)|"Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses."
11095052|NCT01556061|OG000|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
11095053|NCT01556061|OG001|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
11095054|NCT01556061|EG000|Reported Event|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
11095055|NCT01556061|EG001|Reported Event|DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
11095056|NCT01556100|BG000|Baseline|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
11095057|NCT01556100|FG000|Participant Flow|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
11095058|NCT01556100|OG000|Outcome|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
11095059|NCT01556100|EG000|Reported Event|18F-DTBZ AV-133|"18F-DTBZ AV-133 imaging~18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test."
11095060|NCT01556165|BG000|Baseline|Placebo|placebo: tablets, once daily, orally
11095061|NCT01556165|BG001|Baseline|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
11095062|NCT01556165|BG002|Baseline|Total|Total of all reporting groups
11095063|NCT01556165|FG000|Participant Flow|Placebo|placebo: tablets, once daily, orally
11095064|NCT01556165|FG001|Participant Flow|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
11095065|NCT01556165|OG000|Outcome|Placebo|placebo: tablets, once daily, orally
11095066|NCT01556165|OG001|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
11095067|NCT01556165|EG000|Reported Event|Placebo|placebo: tablets, once daily, orally
11095068|NCT01556165|EG001|Reported Event|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
11095069|NCT01556204|BG000|Baseline|Robotic|Robotic surgery
11095070|NCT01556204|BG001|Baseline|Laparoscopic|Laparoscopic surgery
11095071|NCT01556204|BG002|Baseline|Total|Total of all reporting groups
11095072|NCT01556204|FG000|Participant Flow|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
11095073|NCT01556204|FG001|Participant Flow|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
11095074|NCT01556204|OG000|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
11095075|NCT01556204|OG001|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
10827418|NCT00109707|OG001|Outcome|CML-AP With Prior Imatinib Only|Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
11217803|NCT02316613|OG000|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
10827419|NCT00109707|OG002|Outcome|CML-CP|Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827420|NCT00109707|OG000|Outcome|CML-AP With Prior Imatinib Only|Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827421|NCT00109707|OG001|Outcome|CML-AP With Prior Imatinib Only|Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827422|NCT00109707|OG000|Outcome|CML-CP With Prior Imatinib Only|Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827423|NCT00109707|OG002|Outcome|CML-CP|Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827424|NCT00109707|EG000|Reported Event|CML-CP With Prior Imatinib Only|Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827425|NCT00109707|EG001|Reported Event|CML-AP With Prior Imatinib Only|Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827426|NCT00109707|EG002|Reported Event|CML-CP|Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
10827427|NCT00109733|BG000|Baseline|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
10827428|NCT00109733|BG001|Baseline|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
10827429|NCT00109733|BG002|Baseline|Total|Total of all reporting groups
10827430|NCT00109733|FG000|Participant Flow|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
10827431|NCT00109733|FG001|Participant Flow|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
10827432|NCT00109733|OG000|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
10827433|NCT00109733|OG001|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
10827434|NCT00109733|EG000|Reported Event|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
10827435|NCT00109733|EG001|Reported Event|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
10827436|NCT00109772|BG000|Baseline|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
10827437|NCT00109772|BG001|Baseline|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
10827438|NCT00109772|BG002|Baseline|Total|Total of all reporting groups
10827439|NCT00109772|FG000|Participant Flow|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
10827440|NCT00109772|FG001|Participant Flow|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
10827441|NCT00109772|OG000|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
10827442|NCT00109772|OG001|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
11095076|NCT01556204|EG000|Reported Event|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
11095077|NCT01556204|EG001|Reported Event|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
11095078|NCT01556347|BG000|Baseline|Elimination of Immunologic Memory|"A Multi-drug regimen is used to delete immunologic memory in order to reduce or eliminate alloreactive anti-HLA antibodies in highly sensitized heart transplant candidates.~Bortezomib, Thymoglobulin, (rATG), Rituximab, Gamimune N, (IVIG), Plasmapheresis (Multidrug Protocol): Bortezomib, Thymoglobulin, (rATG), Rituximab, Gamimune N, (IVIG), Plasmapheresis"
11095079|NCT01556347|FG000|Participant Flow|Highly Sensitized Heart Transplant Candidates|This was a Single Group Assignment Interventional Study to determine if a multi-drug regimen could be used to delete immunologic memory in order to reduce or eliminate alloreactive anti-HLA antibodies in highly sensitized heart transplant candidates. It was a non-randomized, open label, safety/efficacy (pilot) treatment study. It was hoped that if the calculated panel reactivity antibody (CPRA) was reduced to less than 20% via the protocol, then the patients could become functionally transplantable. There were three phases of the study, an Induction Immunotherapy Phase, a Bortezomib Treatment Phase, and a Recovery Phase. Both patients completed each of the three phases.
11095080|NCT01556347|OG000|Outcome|Highly Sensitized Heart Transplant Candidates|The percentage of patients with a CPRA less than 20% during the Recovery Phase of the protocol
11095081|NCT01556347|OG000|Outcome|Highly Sensitized Heart Transplant Candidates|Highly sensitized heart transplant candidates with a CPRA greater than 50% that complete the Bortezomib treatment phase and are transplanted within one year
11095082|NCT01556347|OG000|Outcome|All Cause Mortality|Mortality for any reason during the study period
11095083|NCT01556347|OG001|Outcome|Serious Adverse Events|The number of study patients with serious adverse events.
11095084|NCT01556347|OG002|Outcome|Other Adverse Events|The number of study patients who had adverse events other than serious.
11095085|NCT01556347|OG000|Outcome|Percentage of Patients With Grade and Above Non-Hematologic Ti|Percentage of patients who experienced a Grade 3 or above non-hematologic toxicity during any phase of the study
11095086|NCT01556347|OG000|Outcome|Highly Sensitized Heart Transplant Candidates|Percentage of study patients with all grades of peripheral neuropathy during the study period
11095087|NCT01556347|OG000|Outcome|Incidnce of CMV, PTLD, PML|Percentage of patients who experience CMV, PTLD or PML within the study period
11095088|NCT01556347|OG000|Outcome|Respiratory Tract Infections|Number of Participants with Respiratory Tract Infections
11095089|NCT01556347|OG001|Outcome|Urinary Tract Infections|Number of participants with urinary tract infections
11095090|NCT01556347|OG000|Outcome|Percentage of Patients With Exacerbation of Heart Failure|The study patients, who all have heart failure and need a heart transplant, but experience an exacerbation of their heart failure during the study period.
11095091|NCT01556347|OG001|Outcome|Percentage of Patients With Exacerbation of Dysrythmias|The percentage of study patients who experienced an exacerbation of the incidence of cardiac dysrhythmias during the study period.
11095092|NCT01556347|OG000|Outcome|Percentage of Patients With Grade 4 Hemotologic Toxicities|The percentage of patients who experienced a grade 4 hematologic toxicity as manifested by a platelet count < 25,000 mm3 or an absolute neutrophil count of < 500/mm3
11095093|NCT01556347|OG000|Outcome|Percentage of TX Patients With AMR at 6 Months|Percentage of study patients who were transplanted and then developed AMR by 6 months after transplant
11095094|NCT01556347|OG001|Outcome|Percentage of TX Patients With AMR at 12 Months|The percentage of study patients who have developed AMR within 12 months of their transplant. This number includes those patients who had AMR diagnosed within 6 months of transplant.
11095095|NCT01556347|OG000|Outcome|Percentage of Pts. Who Develope De Novo or DSA < 1 yr After TX|Study patients who received a transplant and then developed de novo or donor specific antibodies after transplant.
11095096|NCT01556347|OG000|Outcome|Percentage of Transplanted Pt That Are DSA Negative at 1 Year|Study patients who received a transplant during the study period and then are negative for donor specific antibodies at one year after transplant
11095097|NCT01556347|OG000|Outcome|Allograft Survival at 6 Months|Study patients who receive a heart transplant within the study period whose allografts survive to 6 months.
11095098|NCT01556347|OG001|Outcome|Allograft Survival at 12 Months|Study patients who are transplanted and whose allografts survive to one year. This number includes those allografts that survived to 6 months that then survived to 12 months.
11095099|NCT01556347|OG000|Outcome|Percentage of Allografts With Acute Rejection|Allografts implanted within the study period are followed for one year after transplantation and are routinely monitored for allograft rejection.
11095100|NCT01556347|OG000|Outcome|Patients With CPRA < 20% Who Were Not Transplanted|Percentage of patients with a CPRA < 20% but not transplanted within one year
11095101|NCT01556347|OG000|Outcome|Transplant Patient Death|The incidence of death in transplanted patients at one year from transplant
11095102|NCT01556347|OG001|Outcome|Allograft Loss in Transplanted Patients|Study patients who were transplanted and lost their allografts
11314974|NCT03224234|BG001|Baseline|Insulclock Without Feedback (Group B)|"Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock without feedback: Not feedback on insulin administration."
11314975|NCT03224234|BG002|Baseline|Pilot: Insulclock With Feedback (Group A)|Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
11314976|NCT03224234|BG003|Baseline|Pilot:Insulclock Without Feedback (Group B)|"Participants use the Insulclock, but will not receive feedback on insulin administration.~During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device."
11314977|NCT03224234|BG004|Baseline|Total|Total of all reporting groups
11314978|NCT03224234|FG000|Participant Flow|Insulclock With Feedback (Group A)|"Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses."
11314979|NCT03224234|FG001|Participant Flow|Insulclock Without Feedback (Group B)|"Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock without feedback: Not feedback on insulin administration."
11314980|NCT03224234|OG000|Outcome|Insulclock With Feedback (Group A)|"Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses."
11314981|NCT03224234|OG001|Outcome|Insulclock Without Feedback (Group B)|"Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock without feedback: Not feedback on insulin administration."
11314982|NCT03224234|OG002|Outcome|Pilot: Insulclock With Feedback (Group A)|Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
11314983|NCT03224234|OG003|Outcome|Pilot: Insulclock Without Feedback (Group B)|"Participants use the Insulclock, but will not receive feedback on insulin administration.~During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device."
11314984|NCT03224234|OG003|Outcome|Pilot:Insulclock Without Feedback (Group B)|"Participants use the Insulclock, but will not receive feedback on insulin administration.~During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device."
11314985|NCT03224234|OG002|Outcome|Pilot: Insulclock Without Feedback (Group A)|Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
11314986|NCT03224234|EG000|Reported Event|Insulclock With Feedback (Group A)|"Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses."
11314987|NCT03224234|EG001|Reported Event|Insulclock Without Feedback (Group B)|"Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.~Insulclock without feedback: Not feedback on insulin administration."
11314988|NCT03224234|EG002|Reported Event|Pilot: Insulclock With Feedback (Group A)|Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
11314989|NCT03224234|EG003|Reported Event|Pilot: Insulclock Without Feedback (Group B)|"Participants use the Insulclock, but will not receive feedback on insulin administration.~During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device."
11314990|NCT03224299|BG000|Baseline|Treated Subjects|All treated subjects
11314991|NCT03224299|FG000|Participant Flow|Number of Participants|Participants were treated with 2 of 4 study products (IP#1 [OCT/IPA-clear], IP#2 [OCT/IPA-tinted], AC [ChloraPrep Hi-Lite Orange], or NC [0.9% saline]), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
11314992|NCT03224299|FG001|Participant Flow|Number of Sites|Test sites on body
11314993|NCT03224299|OG000|Outcome|Investigational Product #1|Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
11314994|NCT03224299|OG001|Outcome|Investigational Product #2|Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
11314995|NCT03224299|OG002|Outcome|Active Control|ChloraPrep® - Hi-Lite Orange® applicator
11314996|NCT03224299|OG003|Outcome|Negative Control|Sterile 0.9% saline applied with single use applicator
11314997|NCT03224299|OG000|Outcome|IP#1|Investigational Product #1 (IP1) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
11314998|NCT03224299|OG001|Outcome|IP#2|Investigational Product #2 (IP2) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
11314999|NCT03224299|OG002|Outcome|Active Control|Active Control (AC) - ChloraPrep® - Hi-Lite Orange® applicator
11315000|NCT03224299|OG003|Outcome|Negative Control|Negative Control (NC) - Sterile 0.9% saline applied with single use applicator
11315001|NCT03224299|EG000|Reported Event|IP#1|Investigational Product #1 (IP1) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
11315002|NCT03224299|EG001|Reported Event|IP#2|Investigational Product #2 (IP2) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
11315003|NCT03224299|EG002|Reported Event|Active Control|Active Control (AC) - ChloraPrep® - Hi-Lite Orange® applicator
11315004|NCT03224299|EG003|Reported Event|Negative Control|Negative Control (NC) - Sterile 0.9% saline applied with single use applicator
11315005|NCT03224325|BG000|Baseline|Placebo (Pooled)|TAK-831 placebo-matching suspension, orally, QD on Days 1 and 3 to 16.
11315006|NCT03224325|BG001|Baseline|TAK-831 100 mg|TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315007|NCT03224325|BG002|Baseline|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315008|NCT03224325|BG003|Baseline|TAK-831 600 mg|TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315009|NCT03224325|BG004|Baseline|TAK-831 15 mg|TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16.
11315010|NCT03224325|BG005|Baseline|TAK-831 800 mg|TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315011|NCT03224325|BG006|Baseline|TAK-831 1200 mg|TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315012|NCT03224325|BG007|Baseline|Total|Total of all reporting groups
11315013|NCT03224325|FG000|Participant Flow|Placebo (Pooled)|TAK-831 placebo-matching suspension, orally, once daily (QD) on Days 1 and 3 to 16.
11315014|NCT03224325|FG001|Participant Flow|TAK-831 100 mg|TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315015|NCT03224325|FG002|Participant Flow|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315016|NCT03224325|FG003|Participant Flow|TAK-831 600 mg|TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315017|NCT03224325|FG004|Participant Flow|TAK-831 15 mg|TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16.
11315018|NCT03224325|FG005|Participant Flow|TAK-831 800 mg|TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315019|NCT03224325|FG006|Participant Flow|TAK-831 1200 mg|TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315020|NCT03224325|OG000|Outcome|Placebo (Pooled)|TAK-831 placebo-matching suspension, orally, QD on Days 1 and 3 to 16.
11315021|NCT03224325|OG001|Outcome|TAK-831 100 mg|TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315022|NCT03224325|OG002|Outcome|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315023|NCT03224325|OG003|Outcome|TAK-831 600 mg|TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315024|NCT03224325|OG004|Outcome|TAK-831 15 mg|TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16.
11315025|NCT03224325|OG005|Outcome|TAK-831 800 mg|TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315026|NCT03224325|OG006|Outcome|TAK-831 1200 mg|TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315027|NCT03224325|OG000|Outcome|TAK-831 100 mg|TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315028|NCT03224325|OG001|Outcome|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315029|NCT03224325|OG002|Outcome|TAK-831 600 mg|TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315030|NCT03224325|OG003|Outcome|TAK-831 15 mg|TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16.
11315031|NCT03224325|OG004|Outcome|TAK-831 800 mg|TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315032|NCT03224325|OG005|Outcome|TAK-831 1200 mg|TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315033|NCT03224325|EG000|Reported Event|Placebo (Pooled)|TAK-831 placebo-matching suspension, orally, QD on Days 1 and 3 to 16.
11315034|NCT03224325|EG001|Reported Event|TAK-831 100 mg|TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315035|NCT03224325|EG002|Reported Event|TAK-831 300 mg|TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315036|NCT03224325|EG003|Reported Event|TAK-831 600 mg|TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16.
11315037|NCT03224325|EG004|Reported Event|TAK-831 15 mg|TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16.
11315038|NCT03224325|EG005|Reported Event|TAK-831 800 mg|TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315039|NCT03224325|EG006|Reported Event|TAK-831 1200 mg|TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16.
11315040|NCT03224351|BG000|Baseline|Part 1: Placebo|Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.
11315041|NCT03224351|BG001|Baseline|Part 1: VX-659/TEZ/IVA TC - Low Dose|Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315042|NCT03224351|BG002|Baseline|Part 1: VX-659/TEZ/IVA TC - Medium Dose|Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315043|NCT03224351|BG003|Baseline|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315044|NCT03224351|BG004|Baseline|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315045|NCT03224351|BG005|Baseline|Part 2: VX-659/TEZ/IVA TC|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315046|NCT03224351|BG006|Baseline|Part 3: Placebo|Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.
11315047|NCT03224351|BG007|Baseline|Part 3: VX-659/TEZ/VX-561 TC|Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.
11315048|NCT03224351|BG008|Baseline|Total|Total of all reporting groups
11315049|NCT03224351|FG000|Participant Flow|Part 1: Placebo|Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.
11315050|NCT03224351|FG001|Participant Flow|Part 1: VX-659/TEZ/IVA TC - Low Dose|Participants received VX-659 80 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315051|NCT03224351|FG002|Participant Flow|Part 1: VX-659/TEZ/IVA TC - Medium Dose|Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315052|NCT03224351|FG003|Participant Flow|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315053|NCT03224351|FG004|Participant Flow|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315054|NCT03224351|FG005|Participant Flow|Part 2: VX-659/TEZ/IVA TC|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315055|NCT03224351|FG006|Participant Flow|Part 3: Placebo|Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.
11315056|NCT03224351|FG007|Participant Flow|Part 3: VX-659/TEZ/VX-561 TC|Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.
11315057|NCT03224351|OG000|Outcome|Part 1: Placebo|Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.
11315058|NCT03224351|OG001|Outcome|Part 1: VX-659/TEZ/IVA TC - Low Dose|Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315059|NCT03224351|OG002|Outcome|Part 1: VX-659/TEZ/IVA TC - Medium Dose|Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315060|NCT03224351|OG003|Outcome|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315061|NCT03224351|OG004|Outcome|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315062|NCT03224351|OG005|Outcome|Part 2: VX-659/TEZ/IVA TC|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315063|NCT03224351|OG006|Outcome|Part 3: Placebo|Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.
11315064|NCT03224351|OG007|Outcome|Part 3: VX-659/TEZ/VX-561 TC|Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.
11315065|NCT03224351|OG004|Outcome|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315066|NCT03224351|OG003|Outcome|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315067|NCT03224351|OG000|Outcome|Part 1: VX-659/TEZ/IVA TC - Low Dose|Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315068|NCT03224351|OG001|Outcome|Part 1: VX-659/TEZ/IVA TC - Medium Dose|Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315069|NCT03224351|OG002|Outcome|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315070|NCT03224351|OG003|Outcome|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315071|NCT03224351|OG004|Outcome|Part 2: VX-659/TEZ/IVA TC|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315072|NCT03224351|OG005|Outcome|Part 3: VX-659/TEZ/VX-561 TC|Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.
11315073|NCT03224351|EG000|Reported Event|Part 1: Placebo|Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.
11315074|NCT03224351|EG001|Reported Event|Part 1: VX-659/TEZ/IVA TC - Low Dose|Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315075|NCT03224351|EG002|Reported Event|Part 1: VX-659/TEZ/IVA TC - Medium Dose|Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315076|NCT03224351|EG003|Reported Event|Part 1: VX-659/TEZ/IVA TC - High Dose|Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.
11315077|NCT03224351|EG004|Reported Event|Part 2: TEZ/IVA|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11095103|NCT01556347|OG002|Outcome|Hospitalization Due to Infection in Transplanted Patients|Study patients who were transplanted and then required hospitalization for infection within one year of the transplant
11095104|NCT01556347|OG003|Outcome|Non-fatal Serious Cardiac Event|Study patients who were transplanted and had a non-fatal cardiac event(acute MI, congestive heart failure, coronary intervention, etc) at one year
11095105|NCT01556347|EG000|Reported Event|Study Treatment Group|All subjects will receive the study treatment. This is a non-randomized, open label study. The study treatment consists of an Induction phase with Thymoglobulin, Rituximab and Methylprednisolone, a Treatment phase with Bortezomib and a Recovery phase to follow-up and re-immunize and transplant the subject.
11095106|NCT01556425|BG000|Baseline|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
11095107|NCT01556425|BG001|Baseline|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
11095108|NCT01556425|BG002|Baseline|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
11095109|NCT01556425|BG003|Baseline|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
11095110|NCT01556425|BG004|Baseline|Total|Total of all reporting groups
11095111|NCT01556425|FG000|Participant Flow|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
11095112|NCT01556425|FG001|Participant Flow|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
11095113|NCT01556425|FG002|Participant Flow|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
11095114|NCT01556425|FG003|Participant Flow|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
11217804|NCT02316613|OG001|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11217805|NCT02316613|OG000|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11315078|NCT03224351|EG005|Reported Event|Part 2: VX-659/TEZ/IVA TC|Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.
11315079|NCT03224351|EG006|Reported Event|Part 3: Placebo|Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.
11315080|NCT03224351|EG007|Reported Event|Part 3: VX-659/TEZ/VX-561 TC|Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.
11315081|NCT03224390|BG000|Baseline|Encouragement Arm|One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
11315082|NCT03224390|BG001|Baseline|Control Arm|Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
11315083|NCT03224390|BG002|Baseline|Total|Total of all reporting groups
11315084|NCT03224390|FG000|Participant Flow|Encouragement Arm|One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
11315085|NCT03224390|FG001|Participant Flow|Control Arm|Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
11315086|NCT03224390|OG000|Outcome|Encouragement Arm|One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
10827443|NCT00109772|EG000|Reported Event|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
11315087|NCT03224390|OG001|Outcome|Control Arm|Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
11315088|NCT03224390|OG000|Outcome|Encouragement Arm|Women randomized to the encouragement arm will receive an invitation via SMS to try the new digital family planning screening and referral service.
11315089|NCT03224390|OG001|Outcome|Control Arm|Women randomized to the control arm will receive a different set of SMS messages that do NOT include a special encouragement try the new digital family planning screening and referral service.
11315090|NCT03224390|EG000|Reported Event|Encouragement Arm|One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service).
11315091|NCT03224390|EG001|Reported Event|Control Arm|Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service.
11315092|NCT03224403|BG000|Baseline|Placebo|Two placebo caplets taken orally
11315093|NCT03224403|BG001|Baseline|Test ACM 1000 mg|Two test acetaminophen 500 mg tablets taken orally
11315094|NCT03224403|BG002|Baseline|Commercial ACM 1000 mg|Two commercial acetaminophen 500 mg caplets taken orally
11315095|NCT03224403|BG003|Baseline|Commercial IBU 400 mg|Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
11315096|NCT03224403|BG004|Baseline|Total|Total of all reporting groups
11315097|NCT03224403|FG000|Participant Flow|Placebo|Two placebo caplets taken orally
11315098|NCT03224403|FG001|Participant Flow|Test ACM 1000 mg|Two test acetaminophen 500 mg tablets taken orally
11315099|NCT03224403|FG002|Participant Flow|Commercial ACM 1000 mg|Two commercial acetaminophen 500 mg caplets taken orally
11315100|NCT03224403|FG003|Participant Flow|Commercial IBU 400 mg|Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
11315101|NCT03224403|OG000|Outcome|Placebo|Two placebo caplets taken orally
11315102|NCT03224403|OG001|Outcome|Test ACM 1000 mg|Two test acetaminophen 500 mg tablets taken orally
11315103|NCT03224403|OG002|Outcome|Commercial ACM 1000 mg|Two commercial acetaminophen 500 mg caplets taken orally
11315104|NCT03224403|OG003|Outcome|Commercial IBU 400 mg|Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
11315105|NCT03224403|EG000|Reported Event|Placebo|Two placebo caplets taken orally
11315106|NCT03224403|EG001|Reported Event|Test ACM 1000 mg|Two test acetaminophen 500 mg tablets taken orally
11315107|NCT03224403|EG002|Reported Event|Commercial ACM 1000 mg|Two test acetaminophen 500 mg tablets taken orally
11315108|NCT03224403|EG003|Reported Event|Commercial IBU 400 mg|Two commercial ibuprofen 400 mg liquid-filled capsules taken orally
11315109|NCT03224520|BG000|Baseline|Fully Enhanced|"Peer recruitment and recommender CTHC~Recommender CTHC: Enhanced Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315110|NCT03224520|BG001|Baseline|Recommender CTHC Only|"Recommender CTHC and standard online recruitment~Recommender CTHC: Enhanced Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315111|NCT03224520|BG002|Baseline|Peer Recruitment Only|"Peer recruitment and standard CTHC~Standard CTHC: Standard Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315112|NCT03224520|BG003|Baseline|Standard|"Standard online recruitment and standard CTHC~Standard CTHC: Standard Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315113|NCT03224520|BG004|Baseline|Total|Total of all reporting groups
11315114|NCT03224520|FG000|Participant Flow|Fully Enhanced|"Peer recruitment and recommender CTHC~Recommender CTHC: Enhanced Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315115|NCT03224520|FG001|Participant Flow|Recommender CTHC Only|"Recommender CTHC and standard online recruitment~Recommender CTHC: Enhanced Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315116|NCT03224520|FG002|Participant Flow|Peer Recruitment Only|"Peer recruitment and standard CTHC~Standard CTHC: Standard Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315117|NCT03224520|FG003|Participant Flow|Standard|"Standard online recruitment and standard CTHC~Standard CTHC: Standard Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315118|NCT03224520|OG000|Outcome|Fully Enhanced|"Peer recruitment and recommender CTHC~Recommender CTHC: Enhanced Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315119|NCT03224520|OG001|Outcome|Recommender CTHC Only|"Recommender CTHC and standard online recruitment~Recommender CTHC: Enhanced Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315120|NCT03224520|OG002|Outcome|Peer Recruitment Only|"Peer recruitment and standard CTHC~Standard CTHC: Standard Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315121|NCT03224520|OG003|Outcome|Standard|"Standard online recruitment and standard CTHC~Standard CTHC: Standard Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315122|NCT03224520|EG000|Reported Event|Fully Enhanced|"Peer recruitment and recommender CTHC~Recommender CTHC: Enhanced Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315123|NCT03224520|EG001|Reported Event|Recommender CTHC Only|"Recommender CTHC and standard online recruitment~Recommender CTHC: Enhanced Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315124|NCT03224520|EG002|Reported Event|Peer Recruitment Only|"Peer recruitment and standard CTHC~Standard CTHC: Standard Messaging~Peer Recruitment: Tools to facilitate smokers' recruiting their peers"
11315125|NCT03224520|EG003|Reported Event|Standard|"Standard online recruitment and standard CTHC~Standard CTHC: Standard Messaging~Standard Online Recruitment: Search Engine and Social Media Advertisements"
11315126|NCT03224585|BG000|Baseline|Anakinra (3 Days) Then Anakinra (4 Days)|"100 mg subcutaneous injection~Anakinra: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days"
11315127|NCT03224585|BG001|Baseline|Anakinra (3 Days) Then Placebo (4 Days)|"100 mg NaCl 0.9% subcutaneous injection~Placebo: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days"
11315128|NCT03224585|BG002|Baseline|Total|Total of all reporting groups
11315129|NCT03224585|FG000|Participant Flow|Anakinra (3 Days) Then Anakinra (4 Days)|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days"
11315130|NCT03224585|FG001|Participant Flow|Anakinra (3 Days) Then Placebo (4 Days)|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days"
11315131|NCT03224585|OG000|Outcome|All Patients|This group includes all patients enrolled in the clinical trial
11315132|NCT03224585|EG000|Reported Event|Anakinra (3 Days) Then Anakinra (4 Days)|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days"
11315133|NCT03224585|EG001|Reported Event|Anakinra (3 Days) Then Placebo (4 Days)|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.~Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days"
11315134|NCT03224598|BG000|Baseline|No Medical Abrading|"A-101 40% without medically abrading the identified DPN prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315135|NCT03224598|BG001|Baseline|Medically Abrading|"A-101 40% with the identified DPN lesions medically abraded prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315136|NCT03224598|BG002|Baseline|Initial Cohort - no Medical Abrading|"A-101 40% without medically abrading the identified DPN prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%~initial cohort no medical abrading different treatment schedule"
11315137|NCT03224598|BG003|Baseline|Total|Total of all reporting groups
11315138|NCT03224598|FG000|Participant Flow|No Medical Abrading|"A-101 40% without medically abrading the identified DPN prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315139|NCT03224598|FG001|Participant Flow|Medically Abrading|"A-101 40% with the identified DPN lesions medically abraded prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315140|NCT03224598|FG002|Participant Flow|Initial Cohort - no Medical Abrading|initial cohort no medical abrading different treatment schedule
11315141|NCT03224598|OG000|Outcome|No Medical Abrading|"A-101 40% without medically abrading the identified DPN prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
10827444|NCT00109772|EG001|Reported Event|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
11315142|NCT03224598|OG001|Outcome|Medically Abrading|"A-101 40% with the identified DPN lesions medically abraded prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315143|NCT03224598|OG002|Outcome|Initial Cohort - no Medical Abrading|initial cohort no medical abrading different treatment schedule
11315144|NCT03224598|EG000|Reported Event|No Medical Abrading|"A-101 40% without medically abrading the identified DPN prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315145|NCT03224598|EG001|Reported Event|Medically Abrading|"A-101 40% with the identified DPN lesions medically abraded prior to treatment~A-101 Topical Solution 40%: A-101 Topical Solution 40%"
11315146|NCT03224598|EG002|Reported Event|Initial Cohort - no Medical Abrading|initial cohort no medical abrading different treatment schedule
11315147|NCT03225001|BG000|Baseline|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
11315148|NCT03225001|FG000|Participant Flow|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
11315149|NCT03225001|OG000|Outcome|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
11315150|NCT03225001|EG000|Reported Event|Edwards SAPIEN XT THV in Patients With Failing SAVR|"Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.~Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems."
11315151|NCT03225313|BG000|Baseline|Control Group|"normal saline will be injected in the rectus sheath~Normal saline: injected into rectus sheath & locally"
11315152|NCT03225313|BG001|Baseline|Ultra- Sound Rectus Sheath Block Group|"bupivicaine will be injected in the rectus sheath~Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath"
11315153|NCT03225313|BG002|Baseline|Local Infilteration Group|"bupivicaine will be injected locally~Bupivacaine Hydrochloride: injected locally"
11315154|NCT03225313|BG003|Baseline|Total|Total of all reporting groups
11315155|NCT03225313|FG000|Participant Flow|Control Group|"normal saline will be injected in the rectus sheath~Normal saline: injected into rectus sheath & locally"
11315156|NCT03225313|FG001|Participant Flow|Ultra- Sound Rectus Sheath Block Group|"bupivicaine will be injected in the rectus sheath~Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath"
11315157|NCT03225313|FG002|Participant Flow|Local Infilteration Group|"bupivicaine will be injected locally~Bupivacaine Hydrochloride: injected locally"
11315158|NCT03225313|OG000|Outcome|Control Group|"normal saline will be injected in the rectus sheath~Normal saline: injected into rectus sheath & locally"
11315159|NCT03225313|OG001|Outcome|Ultra- Sound Rectus Sheath Block Group|"bupivicaine will be injected in the rectus sheath~Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath"
11315160|NCT03225313|OG002|Outcome|Local Infilteration Group|"bupivicaine will be injected locally~Bupivacaine Hydrochloride: injected locally"
11315161|NCT03225313|OG001|Outcome|Rectus Block Group|"bupivicaine will be injected in the rectus sheath~Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath"
11315162|NCT03225313|OG002|Outcome|Local Group|"bupivicaine will be injected locally~Bupivacaine Hydrochloride: injected locally"
11315163|NCT03225313|EG000|Reported Event|Control Group|"normal saline will be injected in the rectus sheath~Normal saline: injected into rectus sheath & locally"
11315164|NCT03225313|EG001|Reported Event|Ultra- Sound Rectus Sheath Block Group|"bupivicaine will be injected in the rectus sheath~Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath"
11315165|NCT03225313|EG002|Reported Event|Local Infilteration Group|"bupivicaine will be injected locally~Bupivacaine Hydrochloride: injected locally"
11315166|NCT03225573|BG000|Baseline|Egyptian Patients|"Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.~starting from 15 years, males or females"
11315167|NCT03225573|FG000|Participant Flow|Egyptian Patients|"Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.~starting from 15 years, males or females"
11315168|NCT03225573|OG000|Outcome|Egyptian Patients|"Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.~starting from 15 years, males or females"
11315169|NCT03225573|EG000|Reported Event|Egyptian Patients|"Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.~starting from 15 years, males or females"
11315170|NCT03225599|BG000|Baseline|Procedure|The treatment was performed with the patient lying comfortably in a supine position. The examiner's hand was initially placed at the occipito-atlantal junction of the top of the cervical spine to evaluate for fascial restrictions. Any palpated restrictions were released using a technique of myofascial release, where no passive or active range of motion was performed to the cervical region. Once the occipito-atlantal junction was determined to be free of restrictions, fingers were placed on the head using the Vault Hold (Figures 1 & 2). The Vault Hold was used for the administration of the procedure as is standard in osteopathic manipulative medicine by bilateral finger placement: thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone. Each procedure lasted less than 30 minutes.
11315171|NCT03225599|FG000|Participant Flow|Procedure|The treatment was performed with the patient lying comfortably in a supine position. The examiner's hand was initially placed at the occipito-atlantal junction of the top of the cervical spine to evaluate for fascial restrictions. Any palpated restrictions were released using a technique of myofascial release, where no passive or active range of motion was performed to the cervical region. Once the occipito-atlantal junction was determined to be free of restrictions, fingers were placed on the head using the Vault Hold (Figures 1 & 2). The Vault Hold was used for the administration of the procedure as is standard in osteopathic manipulative medicine by bilateral finger placement: thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone. Each procedure lasted less than 30 minutes.
10827445|NCT00109837|BG000|Baseline|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
11217806|NCT02316613|OG000|Outcome|First Induction|During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.
11217807|NCT02316613|OG001|Outcome|Maintenance Therapy|During maintenance therapy the participants received or did not received treatment with the MabThera.
11217808|NCT02316613|EG000|Reported Event|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11217809|NCT02316678|BG000|Baseline|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
11217810|NCT02316678|BG001|Baseline|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
11217811|NCT02316678|BG002|Baseline|Total|Total of all reporting groups
11217812|NCT02316678|FG000|Participant Flow|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
11217813|NCT02316678|FG001|Participant Flow|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
11217814|NCT02316678|OG000|Outcome|Anti-TNF|New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing.
11217815|NCT02316678|OG001|Outcome|Steroids|Prolonged users of steroids defined as either >3000 mg of prednisone (or equivalent) or >600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months.
11217816|NCT02316678|EG000|Reported Event|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
11217817|NCT02316678|EG001|Reported Event|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
11217818|NCT02316717|BG000|Baseline|Treatment Arm A|"IMM-124E, 600 mg three times daily, orally plus matching placebo~IMM-124E: IMM-124E"
11217819|NCT02316717|BG001|Baseline|Treatment Arm B|"IMM-124E, 1200 mg three times daily, orally~IMM-124E: IMM-124E"
11217820|NCT02316717|BG002|Baseline|Treatment Arm C|"Matching placebo, three times daily, orally~Placebo: Matched placebo"
11217821|NCT02316717|BG003|Baseline|Total|Total of all reporting groups
11217822|NCT02316717|FG000|Participant Flow|Treatment Arm A|"IMM-124E, 600 mg three times daily, orally plus matching placebo~IMM-124E: IMM-124E"
11217823|NCT02316717|FG001|Participant Flow|Treatment Arm B|"IMM-124E, 1200 mg three times daily, orally~IMM-124E: IMM-124E"
11217824|NCT02316717|FG002|Participant Flow|Treatment Arm C|"Matching placebo, three times daily, orally~Placebo: Matched placebo"
11217825|NCT02316717|OG000|Outcome|IMM-124E, 600 mg|IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
11217826|NCT02316717|OG001|Outcome|IMM-124E, 1200 mg|IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
11217827|NCT02316717|OG002|Outcome|Matching Placebo|Matching placebo, three times daily, orally 24 weeks of treatment
11217828|NCT02316717|OG000|Outcome|Treatment Arm A|"IMM-124E, 600 mg three times daily, orally plus matching placebo~IMM-124E: IMM-124E"
11217829|NCT02316717|OG001|Outcome|Treatment Arm B|"IMM-124E, 1200 mg three times daily, orally~IMM-124E: IMM-124E"
11217830|NCT02316717|OG002|Outcome|Treatment Arm C|"Matching placebo, three times daily, orally~Placebo: Matched placebo"
11217831|NCT02316717|EG000|Reported Event|IMM-124E, 600 mg|IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
11217832|NCT02316717|EG001|Reported Event|IMM-124E, 1200 mg|IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
11217833|NCT02316717|EG002|Reported Event|Matching Placebo|Matching placebo, three times daily, orally 24 weeks of treatment
11217834|NCT02316769|BG000|Baseline|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11217835|NCT02316769|BG001|Baseline|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11217836|NCT02316769|BG002|Baseline|Total|Total of all reporting groups
11217837|NCT02316769|FG000|Participant Flow|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11217838|NCT02316769|FG001|Participant Flow|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11217839|NCT02316769|OG000|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11217840|NCT02316769|OG001|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11217841|NCT02316769|EG000|Reported Event|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11217842|NCT02316769|EG001|Reported Event|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11217843|NCT02316847|BG000|Baseline|Diazapam Nasal Spray (DZNS) Adults|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217844|NCT02316847|BG001|Baseline|Diazapam Nasal Spray (DZNS) Adolescents|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217845|NCT02316847|BG002|Baseline|Total|Total of all reporting groups
11315172|NCT03225599|OG000|Outcome|Procedure|The treatment was performed with the patient lying comfortably in a supine position. The examiner's hand was initially placed at the occipito-atlantal junction of the top of the cervical spine to evaluate for fascial restrictions. Any palpated restrictions were released using a technique of myofascial release, where no passive or active range of motion was performed to the cervical region. Once the occipito-atlantal junction was determined to be free of restrictions, fingers were placed on the head using the Vault Hold (Figures 1 & 2). The Vault Hold was used for the administration of the procedure as is standard in osteopathic manipulative medicine by bilateral finger placement: thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone. Each procedure lasted less than 30 minutes.
11315173|NCT03225599|EG000|Reported Event|Procedure|The treatment was performed with the patient lying comfortably in a supine position. The examiner's hand was initially placed at the occipito-atlantal junction of the top of the cervical spine to evaluate for fascial restrictions. Any palpated restrictions were released using a technique of myofascial release, where no passive or active range of motion was performed to the cervical region. Once the occipito-atlantal junction was determined to be free of restrictions, fingers were placed on the head using the Vault Hold (Figures 1 & 2). The Vault Hold was used for the administration of the procedure as is standard in osteopathic manipulative medicine by bilateral finger placement: thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone. Each procedure lasted less than 30 minutes.
11315174|NCT03225859|BG000|Baseline|Self-Management Program|"Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.~Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals"
11315175|NCT03225859|FG000|Participant Flow|Self-Management Program|"Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.~Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals"
11315176|NCT03225859|OG000|Outcome|Self-Management Program|"Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.~Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals"
11315177|NCT03225859|EG000|Reported Event|Self-Management Program|"Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.~Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals"
11315178|NCT03226223|BG000|Baseline|Naltrexone 0mg First, Then Naltrexone 50mg|"This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315179|NCT03226223|BG001|Baseline|Naltrexone 50mg First, Then Naltrexone 0mg|"This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315180|NCT03226223|BG002|Baseline|Total|Total of all reporting groups
11315181|NCT03226223|FG000|Participant Flow|Naltrexone 0mg First, Then Naltrexone 50mg|"This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315182|NCT03226223|FG001|Participant Flow|Naltrexone 50mg First, Then Naltrexone 0mg|"This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315183|NCT03226223|OG000|Outcome|Naltrexone 0 mg|"This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315184|NCT03226223|OG001|Outcome|Naltrexone 50 mg|"This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315185|NCT03226223|EG000|Reported Event|Naltrexone 0 mg|"This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315186|NCT03226223|EG001|Reported Event|Naltrexone 50 mg|"This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).~Intranasal Methamphetamine: Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)"
11315187|NCT03226249|BG000|Baseline|Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT|"All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.~After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.~Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).~Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.~See schema for details."
11315188|NCT03226249|FG000|Participant Flow|Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT|"All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.~After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.~Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).~Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.~See schema for details."
11315189|NCT03226249|OG000|Outcome|Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT|"All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.~After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.~Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).~Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.~See schema for details."
11315190|NCT03226249|EG000|Reported Event|Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT|"All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.~After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.~Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).~Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.~See schema for details."
11315191|NCT03226275|BG000|Baseline|Fasting: First Bisoprolol-Amlodipine FDC, Then Both Separately|Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days.
11315192|NCT03226275|BG001|Baseline|Fasting: First Bisoprolol and Amlodipine Separately, Then FDC|Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days.
10827446|NCT00109837|FG000|Participant Flow|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
11217846|NCT02316847|FG000|Participant Flow|DZNS - Adolescents (Ages 12 - 15)|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217847|NCT02316847|FG001|Participant Flow|DZNS - Adults (Ages 16 - 65)|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217848|NCT02316847|OG000|Outcome|Diazepam Nasal Spray (Adults)|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217849|NCT02316847|OG001|Outcome|Diazepam Nasal Spray (Adolescents)|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217850|NCT02316847|OG000|Outcome|Adults|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217851|NCT02316847|OG001|Outcome|Adolescents|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217852|NCT02316847|EG000|Reported Event|Adults|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217853|NCT02316847|EG001|Reported Event|Adolescents|One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down.
11217854|NCT02317016|BG000|Baseline|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
11217855|NCT02317016|FG000|Participant Flow|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).~In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
11217856|NCT02317016|OG000|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11217857|NCT02317016|OG001|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11217858|NCT02317016|OG000|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11217859|NCT02317016|EG000|Reported Event|Overall Safety Population|Parts A and B of the study combined.
11217860|NCT02317016|EG001|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34) and single 20 mg oral doses of rosuvastatin on Day 1 and Day 32.
11217861|NCT02317016|EG002|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
11217862|NCT02317042|BG000|Baseline|Participant Baseline|Participant's meeting the eligibility criteria had their baseline information collected at their Visit 1.
11217863|NCT02317042|FG000|Participant Flow|Standard ST Mode -> AutoEPAP iVAPS -> Fixed EPAP iVAPS|"Night 1 Participants underwent the first PSG study on ST Mode receiving their standard NIV therapy through the clinical trial device Juno. During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy.~Night 2 Participants underwent a PSG study on the AutoEPAP iVAPS mode Night 3 Participants underwent a PSG study on the Fixed EPAP iVAPS mode"
11217864|NCT02317042|FG001|Participant Flow|Standard ST Mode -> FixedEPAP iVAPS -> AutoEPAP iVAPS Mode|"Night 1 Participants underwent the first PSG study on ST Mode receiving their standard NIV therapy through the clinical trial device Juno. During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy.~Night 2 Participants underwent a PSG study on the FixedEPAP iVAPS mode Night 3 Participants underwent a PSG study on the AutoEPAP iVAPS mode"
11217865|NCT02317042|OG000|Outcome|Standard ST Mode|"Participants underwent the first PSG study (Titration Night 1) on ST Mode whilst receiving their standard NIV therapy through the clinical trial device Juno. During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy."
11217866|NCT02317042|OG001|Outcome|AutoEPAP iVAPS|"Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation.~Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first."
11217867|NCT02317042|OG002|Outcome|FixedEPAP iVAPS|"Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation.~Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first."
11217868|NCT02317042|EG000|Reported Event|Standard ST Mode|Standard ST mode.
11217869|NCT02317042|EG001|Reported Event|AutoEPAP iVAPS|AutoEPAP iVAPS.
11217870|NCT02317042|EG002|Reported Event|FixedEPAP iVAPS|FixedEPAP iVAPS.
11217871|NCT02317432|BG000|Baseline|CBT + InVEST Exercise|10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
11217872|NCT02317432|BG001|Baseline|Enhanced Usual Care|Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
11217873|NCT02317432|BG002|Baseline|Total|Total of all reporting groups
11217874|NCT02317432|FG000|Participant Flow|CBT + InVEST Exercise|10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
11217875|NCT02317432|FG001|Participant Flow|Enhanced Usual Care|Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
11217876|NCT02317432|OG000|Outcome|CBT + InVEST Exercise|"10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.~Comparison of a combined CBT + exercise intervention and enhanced usual care"
11217877|NCT02317432|OG001|Outcome|Enhanced Usual Care|"Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.~Comparison of a combined CBT + exercise intervention and enhanced usual care"
11217878|NCT02317432|EG000|Reported Event|CBT + InVEST Exercise|10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
11217879|NCT02317432|EG001|Reported Event|Enhanced Usual Care|Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
11217880|NCT02317510|BG000|Baseline|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
11217881|NCT02317510|BG001|Baseline|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
11217882|NCT02317510|BG002|Baseline|Total|Total of all reporting groups
11217883|NCT02317510|FG000|Participant Flow|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11217884|NCT02317510|FG001|Participant Flow|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11217885|NCT02317510|OG000|Outcome|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
11217886|NCT02317510|OG001|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
11217887|NCT02317510|OG000|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11217888|NCT02317510|OG001|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11217889|NCT02317510|OG001|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11217890|NCT02317510|EG000|Reported Event|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11217891|NCT02317510|EG001|Reported Event|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11217892|NCT02317549|BG000|Baseline|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
11217893|NCT02317549|BG001|Baseline|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
11217894|NCT02317549|BG002|Baseline|Total|Total of all reporting groups
11217895|NCT02317549|FG000|Participant Flow|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
11217896|NCT02317549|FG001|Participant Flow|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
11217897|NCT02317549|OG000|Outcome|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
11217898|NCT02317549|OG001|Outcome|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
11217899|NCT02317549|EG000|Reported Event|Tranexemic Acid|"Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube~LB1148"
11217900|NCT02317549|EG001|Reported Event|Placebo|"Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube~Placebo"
11217901|NCT02317562|BG000|Baseline|I10E Arm|"Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.~Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks."
11217902|NCT02317562|FG000|Participant Flow|I10E Arm|"Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.~Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks."
11217903|NCT02317562|OG000|Outcome|I10E Arm|"Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.~Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks."
11217904|NCT02317562|EG000|Reported Event|I10E Arm|"Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.~Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks."
11217905|NCT02317575|BG000|Baseline|Overall Study|Participants were administered LY900014 SC Tests A, B, C, and D, with that of 15 U of insulin lispro alone (Reference) in healthy subjects.
11095115|NCT01556425|OG000|Outcome|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
11095116|NCT01556425|OG001|Outcome|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
11095117|NCT01556425|OG002|Outcome|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
11095118|NCT01556425|OG003|Outcome|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
11095119|NCT01556425|EG000|Reported Event|Vivitrol Only|"The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.~Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks."
11095120|NCT01556425|EG001|Reported Event|VIVITROL&Opiate Abstinence Reinforcement|This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
11095121|NCT01556425|EG002|Reported Event|Opiate Abstinence Reinforcement Only|"This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.~Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour."
11095122|NCT01556425|EG003|Reported Event|Usual Care Control|"This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.~Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling."
11095123|NCT01556438|BG000|Baseline|100 mg Tabalumab+BTZ IV+Dex|Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
11095124|NCT01556438|BG001|Baseline|300 mg Tabalumab+BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11095125|NCT01556438|BG002|Baseline|Total|Total of all reporting groups
11095126|NCT01556438|FG000|Participant Flow|100 mg Tabalumab+BTZ IV+Dex|Cohort 1. 100 mg tabalumab (LY2127399)intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
11095127|NCT01556438|FG001|Participant Flow|300 mg Tabalumab+ BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11315193|NCT03226275|BG002|Baseline|Fed: First Bisoprolol-Amlodipine FDC, Then Both Separately|Participants received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days.
11315194|NCT03226275|BG003|Baseline|Fed: First Bisoprolol and Amlodipine Separately, Then FDC|Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days.
11315195|NCT03226275|BG004|Baseline|Total|Total of all reporting groups
11315196|NCT03226275|FG000|Participant Flow|Fasting: First Bisoprolol-Amlodipine FDC, Then Both Separately|Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days.
11315197|NCT03226275|FG001|Participant Flow|Fasting: First Bisoprolol and Amlodipine Separately, Then FDC|Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days.
11315198|NCT03226275|FG002|Participant Flow|Fed: First Bisoprolol-Amlodipine FDC, Then Both Separately|Participants received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days.
11315199|NCT03226275|FG003|Participant Flow|Fed: First Bisoprolol and Amlodipine Separately, Then FDC|Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days.
11315200|NCT03226275|OG000|Outcome|Fasting: Bisoprolol-Amlodipine FDC|All participants who received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet as a single oral dose on Day 1 or Day 15 under fasting conditions.
11315201|NCT03226275|OG001|Outcome|Fasting: Bisoprolol and Amlodipine Separately|All participants who received a single dose of 5 mg bisoprolol and a single dose of 5 mg amlodipine given concomitantly on Day 1 or Day 15 under fasting conditions.
11315202|NCT03226275|OG002|Outcome|Fed: Bisoprolol-Amlodipine FDC|All participants who received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet as a single oral dose on Day 1 or Day 15 under fed conditions.
11315203|NCT03226275|OG003|Outcome|Fed: Bisoprolol and Amlodipine Separately|All participants who received a single dose of 5 mg bisoprolol and a single dose of 5 mg amlodipine given concomitantly on Day 1 or Day 15 under fed conditions.
11315204|NCT03226275|EG000|Reported Event|Fasting: Bisoprolol-Amlodipine FDC|All participants who received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet as a single oral dose on Day 1 or Day 15 under fasting conditions.
11315205|NCT03226275|EG001|Reported Event|Fasting: Bisoprolol and Amlodipine Separately|All participants who received a single dose of 5 mg bisoprolol and a single dose of 5 mg amlodipine given concomitantly on Day 1 or Day 15 under fasting conditions.
11315206|NCT03226275|EG002|Reported Event|Fed: Bisoprolol-Amlodipine FDC|All participants who received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet as a single oral dose on Day 1 or Day 15 under fed conditions.
11315207|NCT03226275|EG003|Reported Event|Fed: Bisoprolol and Amlodipine Separately|All participants who received a single dose of 5 mg bisoprolol and a single dose of 5 mg amlodipine given concomitantly on Day 1 or Day 15 under fed conditions.
11315208|NCT03226353|BG000|Baseline|Overall Participants|Habitual and refitted wearers of omafilcon A were refitted with somofilcon A. Two participants were habitual wearers of omafilcon A; the remaining participants were habitual wearers of other lens types. One participant was excluded from all analysis due to protocol deviation and one participant was excluded from all analysis due to an adverse event.
11315209|NCT03226353|FG000|Participant Flow|Overall Participants|Habitual and refitted wearers of Omafilcon A were refitted with Somofilcon A
11315210|NCT03226353|OG000|Outcome|Overall Participants|Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day
11315211|NCT03226353|OG000|Outcome|Somofilcon A|All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
11315212|NCT03226353|OG001|Outcome|Omafilcon A|All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
11315213|NCT03226353|EG000|Reported Event|Somofilcon A|Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types.
11315214|NCT03226353|EG001|Reported Event|Omafilcon A|Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types.
11315215|NCT03226366|BG000|Baseline|Pre-implementation (Intervention Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315216|NCT03226366|BG001|Baseline|Post-implementation (Intervention Site)|"Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team (swarming) after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016~Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate"
11095128|NCT01556438|OG000|Outcome|100 mg Tabalumab+BTZ IV+Dex|Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
11095129|NCT01556438|OG001|Outcome|300 mg Tabalumab+BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11095130|NCT01556438|OG001|Outcome|300 mg Tabalumab+ IV BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
11095131|NCT01556438|OG002|Outcome|300 mg Tabalumab+ SC BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
11095132|NCT01556438|OG000|Outcome|100 mg Tabalumab+BTZ IV+Dex|"Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.~LY2127399: Administered IV~Bortezomib IV: Administered IV~Dexamethasone: Administered orally"
11095133|NCT01556438|OG001|Outcome|300 mg Tabalumab IV BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
11095134|NCT01556438|OG001|Outcome|300 mg Tabalumab+ IV BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11095135|NCT01556438|OG001|Outcome|300 mg Tabalumab+BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV or SC.
11095136|NCT01556438|OG000|Outcome|100 mg Tabalumab+BTZ IV+Dex|"Cohort 1. 100 mg tabalumab (LY2127399)intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.~Bortezomib IV: Administered IV~Dexamethasone: Administered orally"
11095137|NCT01556438|OG001|Outcome|300 mg Tabalumab+BTZ IV+Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11095138|NCT01556438|EG000|Reported Event|100 mg Tabalumab+BTZ IV+Dex|Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
11095139|NCT01556438|EG001|Reported Event|300 mg Tabalumab+BTZ +Dex|Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
11095140|NCT01556451|BG000|Baseline|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
11095141|NCT01556451|FG000|Participant Flow|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
11095142|NCT01556451|OG000|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
11095143|NCT01556451|EG000|Reported Event|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
11095144|NCT01556581|BG000|Baseline|Usual Care (UC)|"The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.~Usual Care (UC): Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress."
11095145|NCT01556581|BG001|Baseline|Early Physical Therapy (PT)|"All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.~Early Physical Therapy (PT): Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms)."
11095146|NCT01556581|BG002|Baseline|Total|Total of all reporting groups
11095147|NCT01556581|FG000|Participant Flow|Usual Care (UC)|"The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.~Usual Care (UC): Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress."
11217906|NCT02317575|FG000|Participant Flow|Part A Sequence 1, CDABR|Period 1: LY900014 Test C, Period 2: LY900014 Test D, Period 3: LY900014 Test A, Period 4: LY900014 Test B, Period 5: Reference (R) = insulin lispro
11315217|NCT03226366|BG002|Baseline|Pre-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315218|NCT03226366|BG003|Baseline|Post-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016
11315219|NCT03226366|BG004|Baseline|Total|Total of all reporting groups
11315220|NCT03226366|FG000|Participant Flow|Pre-implementation (Intervention Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315221|NCT03226366|FG001|Participant Flow|Post-implementation (Intervention Site)|"Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team (swarming) after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016~Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate"
11315222|NCT03226366|FG002|Participant Flow|Pre-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315223|NCT03226366|FG003|Participant Flow|Post-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016
11315224|NCT03226366|OG000|Outcome|Pre-implementation (Intervention Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315225|NCT03226366|OG001|Outcome|Post-implementation (Intervention Site)|"Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team (swarming) after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016~Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate"
11315226|NCT03226366|OG002|Outcome|Pre-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315227|NCT03226366|OG003|Outcome|Post-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016
11315228|NCT03226366|EG000|Reported Event|Pre-implementation (Intervention Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315229|NCT03226366|EG001|Reported Event|Post-implementation (Intervention Site)|"Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team (swarming) after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016~Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate"
11315230|NCT03226366|EG002|Reported Event|Pre-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
11315231|NCT03226366|EG003|Reported Event|Post-implementation (Control Site)|Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016
11315232|NCT03226392|BG000|Baseline|QAW039|QAW039 150mg once daily
11315233|NCT03226392|BG001|Baseline|Placebo|Placebo once daily
11315234|NCT03226392|BG002|Baseline|Total|Total of all reporting groups
11315235|NCT03226392|FG000|Participant Flow|QAW039|QAW039 150mg once daily
11315236|NCT03226392|FG001|Participant Flow|Placebo|Placebo once daily
11315237|NCT03226392|OG000|Outcome|QAW039|QAW039 150mg once daily
11315238|NCT03226392|OG001|Outcome|Placebo|Placebo once daily
11315239|NCT03226392|EG000|Reported Event|QAW039 150 mg|QAW039 150 mg
11315240|NCT03226392|EG001|Reported Event|Placebo|Placebo
11315241|NCT03226457|BG000|Baseline|Baseline Characteristics|N = 23, Crossover study design. Baseline characteristics
11315242|NCT03226457|FG000|Participant Flow|Empagliflozin/Placebo|"Treatment Sequence:~Empagliflozin (SGLT2 inhibitor) 25mg capsules once daily for 6 weeks~Empagliflozin 25mg: Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered.~Minimum of a 2 week washout period.~6 weeks of placebo"
11315243|NCT03226457|FG001|Participant Flow|Placebo/Empagliflozin|"Treatment Sequence:~Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator~Placebo oral capsule: Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered.~Minimum of 2 week washout period~6 weeks of Empagliflozin 25mg: Empagliflozin (SGLT2 inhibitor) 25 mg once daily"
11315244|NCT03226457|OG000|Outcome|Empagliflozin|"Empagliflozin (SGLT2 inhibitor) 25mg capsules once daily for 6 weeks~Empagliflozin 25mg: Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered."
11315245|NCT03226457|OG001|Outcome|Placebo|"Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator~Placebo oral capsule: Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered."
11315246|NCT03226457|EG000|Reported Event|Empagliflozin|"Empagliflozin (SGLT2 inhibitor) 25mg capsules once daily for 6 weeks~Empagliflozin 25mg: Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered."
11315247|NCT03226457|EG001|Reported Event|Placebo|"Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator~Placebo oral capsule: Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks~Frusemide: Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered."
11315248|NCT03226652|BG000|Baseline|Patients With Clinically Suspected Sleep Disordered Breathing (SDB)|Patients with clinically suspected SDB investigated with respiratory polygraphy.
11315249|NCT03226652|FG000|Participant Flow|Patients With Clinically Suspected Sleep Disordered Breathing (SDB)|Patients with clinically suspected SDB investigated with respiratory polygraphy.
11315250|NCT03226652|OG000|Outcome|Patients With Clinically Suspected Sleep Disordered Breathing (SDB)|Patients with clinically suspected SDB investigated with respiratory polygraphy.
11315251|NCT03226652|EG000|Reported Event|Patients With Clinically Suspected Sleep Disordered Breathing (SDB)|Patients with clinically suspected SDB investigated with respiratory polygraphy.
11315252|NCT03226691|BG000|Baseline|Experimental: Plerixafor|Plerixafor at a single dose of 240 microgram/kg
11315253|NCT03226691|FG000|Participant Flow|Experimental: Plerixafor|Plerixafor at a single dose of 240 microgram/kg
11315254|NCT03226691|OG000|Outcome|Experimental: Plerixafor|Plerixafor at a single dose of 240 microgram/kg
11315255|NCT03226691|EG000|Reported Event|Experimental: Plerixafor|Plerixafor at a single dose of 240 microgram/kg
11315256|NCT03226769|BG000|Baseline|Thermalon|Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
11315257|NCT03226769|BG001|Baseline|TrueTear™|Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
11315258|NCT03226769|BG002|Baseline|Total|Total of all reporting groups
11315259|NCT03226769|FG000|Participant Flow|Thermalon|Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
11315260|NCT03226769|FG001|Participant Flow|TrueTear™|Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
11315261|NCT03226769|OG000|Outcome|Thermalon|Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
11315262|NCT03226769|OG001|Outcome|TrueTear™|Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
11315263|NCT03226769|EG000|Reported Event|Thermalon|Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
11315264|NCT03226769|EG001|Reported Event|TrueTear™|Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
11315265|NCT03226899|BG000|Baseline|Placebo + XOI|placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
11315266|NCT03226899|BG001|Baseline|Lesinurad + XOI|lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
11315267|NCT03226899|BG002|Baseline|Total|Total of all reporting groups
11315268|NCT03226899|FG000|Participant Flow|Placebo + XOI|Placebo oral tablet once daily (QD) plus a stable, medically appropriate dose of an xanthine oxidase inhibitor (XOI)
11315269|NCT03226899|FG001|Participant Flow|Lesinurad + XOI|lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
11315270|NCT03226899|OG000|Outcome|Placebo + XOI|placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
11315271|NCT03226899|OG001|Outcome|Lesinurad + XOI|lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
11315272|NCT03226899|EG000|Reported Event|Placebo + XOI|placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
11315273|NCT03226899|EG001|Reported Event|Lesinurad + XOI|lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
11315274|NCT03227445|BG000|Baseline|All Study Participants|Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period.
11315275|NCT03227445|FG000|Participant Flow|ELLIPTA/DISKUS+HANDIHALER/Q1|Participants received placebo via ELLIPTA dry powder inhaler (DPI) in period 1 and DISKUS DPI + HandiHaler in period 2, followed by preference questionnaire (PQ) version 1. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study
11315276|NCT03227445|FG001|Participant Flow|ELLIPTA/DISKUS+HANDIHALER/Q2|Participants received placebo via ELLIPTA DPI in period 1 and DISKUS DPI + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study
11315277|NCT03227445|FG002|Participant Flow|DISKUS+HANDIHALER/ELLIPTA/Q1|Participants received placebo via DISKUS DPI + HandiHaler in period 1 and ELLIPTA DPI in period 2, followed by PQ1. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study
11315278|NCT03227445|FG003|Participant Flow|DISKUS+HANDIHALER/ELLIPTA/Q2|Participants received placebo via DISKUS DPI + HandiHaler in period 1 and ELLIPTA DPI in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study
11315279|NCT03227445|OG000|Outcome|ELLIPTA|Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
11315280|NCT03227445|OG001|Outcome|DISKUS + HANDIHALER|Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
11315281|NCT03227445|OG001|Outcome|DISKUS|Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
11315282|NCT03227445|OG002|Outcome|HandiHaler|Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
11315283|NCT03227445|OG000|Outcome|All Study Participants|Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. All participants on study received placebo only and participant flow reflects this as the only treatment.
11315284|NCT03227445|OG001|Outcome|DISKUS + HandiHaler|Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
11315285|NCT03227445|EG000|Reported Event|All Study Participants|Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period.
11315286|NCT03227692|BG000|Baseline|Persona With iASSIST Knee|"Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.~iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone."
11315287|NCT03227692|BG001|Baseline|Persona Without iASSIST Knee|"Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis."
11315288|NCT03227692|BG002|Baseline|Total|Total of all reporting groups
11315289|NCT03227692|FG000|Participant Flow|Persona With iASSIST Knee|"Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.~iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone."
11315290|NCT03227692|FG001|Participant Flow|Persona Without iASSIST Knee|"Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis."
11315291|NCT03227692|OG000|Outcome|Persona With iASSIST Knee|"Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.~iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone."
11315292|NCT03227692|OG001|Outcome|Persona Without iASSIST Knee|"Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis."
11315293|NCT03227692|EG000|Reported Event|Persona With iASSIST Knee|"Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.~iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone."
11315294|NCT03227692|EG001|Reported Event|Persona Without iASSIST Knee|"Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.~Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.~Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis."
11315295|NCT03227861|BG000|Baseline|D/C/F/TAF|Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.
11315296|NCT03227861|FG000|Participant Flow|D/C/F/TAF|Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).
11315297|NCT03227861|OG000|Outcome|D/C/F/TAF: Main Study|Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.
11315298|NCT03227861|OG000|Outcome|D/C/F/TAF: Extension Study|Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).
11315299|NCT03227861|EG000|Reported Event|D/C/F/TAF: Main Study|Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.
11315300|NCT03227861|EG001|Reported Event|D/C/F/TAF: Extension Study|Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).
11315301|NCT03228017|BG000|Baseline|Psoriatic Disease Patients|"Moderate to severe psoriatic disease~Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation."
11315302|NCT03228017|BG001|Baseline|Healthy Control|Healthy Control
11315303|NCT03228017|BG002|Baseline|Total|Total of all reporting groups
11315304|NCT03228017|FG000|Participant Flow|Psoriatic Disease Patients|"Moderate to severe psoriatic disease~Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation."
11315305|NCT03228017|FG001|Participant Flow|Healthy Control|Healthy Control
11315306|NCT03228017|OG000|Outcome|Psoriatic Disease Patients|"Moderate to severe psoriatic disease~Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation."
11315307|NCT03228017|OG001|Outcome|Healthy Control|Healthy Control
11315308|NCT03228017|EG000|Reported Event|Psoriatic Disease Patients|"Moderate to severe psoriatic disease~Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation."
11315309|NCT03228017|EG001|Reported Event|Healthy Control|Healthy Control
11315310|NCT03228212|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11315311|NCT03228212|FG000|Participant Flow|Test/Control/Control|Subjects that wore the Test lens during the first period, and the control lens during the second and third period of the study.
11315312|NCT03228212|FG001|Participant Flow|Control/Test/Test|Subjects that wore the Control lens during the first period and the Test lens during the second and third period.
11315313|NCT03228212|OG000|Outcome|Test|Subjects that wore the Test lens during any of the 3 periods of the study.
11315314|NCT03228212|OG001|Outcome|Control|Subjects that wore the Control lens during any of the 3 periods of the study.
11315315|NCT03228212|EG000|Reported Event|Test|Subjects that wore the Test lens during any of the 3 periods of the study.
11315316|NCT03228212|EG001|Reported Event|Control|Subjects that wore the Control lens during any of the 3 periods of the study.
11315317|NCT03228420|BG000|Baseline|HF10 Therapy Plus CMM|"The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management~Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation"
11315318|NCT03228420|BG001|Baseline|CMM Alone|"Conventional Medical Management~CMM: Conventional Medical Management"
11315319|NCT03228420|BG002|Baseline|Total|Total of all reporting groups
11315320|NCT03228420|FG000|Participant Flow|HF10 Therapy Plus CMM|"The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management~Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation"
11315321|NCT03228420|FG001|Participant Flow|CMM Alone|"Conventional Medical Management~CMM: Conventional Medical Management"
11315322|NCT03228420|OG000|Outcome|HF10 Therapy Plus CMM|"The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management~Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation"
11315323|NCT03228420|OG001|Outcome|CMM Alone|"Conventional Medical Management~CMM: Conventional Medical Management"
11315324|NCT03228420|EG000|Reported Event|HF10 Therapy Plus CMM|"The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management~Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation"
11315325|NCT03228420|EG001|Reported Event|CMM Alone|"Conventional Medical Management~CMM: Conventional Medical Management"
11315326|NCT03228433|BG000|Baseline|Cohorts 1-5: Placebo|TAK-418 placebo-matching, capsule, orally, once on Day 1.
11315327|NCT03228433|BG001|Baseline|Cohort 1: TAK-418 5 mg|TAK-418 5 mg, capsule, orally, once on Day 1.
11315328|NCT03228433|BG002|Baseline|Cohort 2: TAK-418 15 mg|TAK-418 15 mg, capsule, orally, once on Day 1.
11315329|NCT03228433|BG003|Baseline|Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed|TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
11315330|NCT03228433|BG004|Baseline|Cohort 4: TAK-418 40 mg|TAK-418 40 mg, capsule, orally, once on Day 1.
11315331|NCT03228433|BG005|Baseline|Cohort 5: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once on Day 1.
11315332|NCT03228433|BG006|Baseline|Total|Total of all reporting groups
11315333|NCT03228433|FG000|Participant Flow|Cohorts 1-5: Placebo|TAK-418 placebo-matching, capsule, orally, once on Day 1.
11315334|NCT03228433|FG001|Participant Flow|Cohort 1: TAK-418 5 mg|TAK-418 5 milligram (mg), capsule, orally, once on Day 1.
11315335|NCT03228433|FG002|Participant Flow|Cohort 2: TAK-418 15 mg|TAK-418 15 mg, capsule, orally, once on Day 1.
11315336|NCT03228433|FG003|Participant Flow|Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed|TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
11315337|NCT03228433|FG004|Participant Flow|Cohort 4: TAK-418 40 mg|TAK-418 40 mg, capsule, orally, once on Day 1.
11315338|NCT03228433|FG005|Participant Flow|Cohort 5: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once on Day 1.
11315339|NCT03228433|OG000|Outcome|Cohorts 1-5: Placebo|TAK-418 placebo-matching, capsule, orally, once on Day 1.
11315340|NCT03228433|OG001|Outcome|Cohort 1: TAK-418 5 mg|TAK-418 5 mg, capsule, orally, once on Day 1.
11315341|NCT03228433|OG002|Outcome|Cohort 2: TAK-418 15 mg|TAK-418 15 mg, capsule, orally, once on Day 1.
11315342|NCT03228433|OG003|Outcome|Cohort 3A: TAK-418 30 mg Fasted|TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
11315343|NCT03228433|OG004|Outcome|Cohort 3B: TAK-418 30 mg Fed|TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
11315344|NCT03228433|OG005|Outcome|Cohort 4: TAK-418 40 mg|TAK-418 40 mg, capsule, orally, once on Day 1.
11315345|NCT03228433|OG006|Outcome|Cohort 5: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once on Day 1.
11315346|NCT03228433|OG000|Outcome|Cohort 1: TAK-418 5 mg|TAK-418 5 mg, capsule, orally, once on Day 1.
11315347|NCT03228433|OG001|Outcome|Cohort 2: TAK-418 15 mg|TAK-418 15 mg, capsule, orally, once on Day 1.
11315348|NCT03228433|OG002|Outcome|Cohort 3A: TAK-418 30 mg Fasted|TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
11315349|NCT03228433|OG003|Outcome|Cohort 3B: TAK-418 30 mg Fed|TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
11315350|NCT03228433|OG004|Outcome|Cohort 4: TAK-418 40 mg|TAK-418 40 mg, capsule, orally, once on Day 1.
11315351|NCT03228433|OG005|Outcome|Cohort 5: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once on Day 1.
11315352|NCT03228433|EG000|Reported Event|Cohorts 1-5: Placebo|TAK-418 placebo-matching, capsule, orally, once on Day 1.
11315353|NCT03228433|EG001|Reported Event|Cohort 1: TAK-418 5 mg|TAK-418 5 mg, capsule, orally, once on Day 1.
11315354|NCT03228433|EG002|Reported Event|Cohort 2: TAK-418 15 mg|TAK-418 15 mg, capsule, orally, once on Day 1.
11315355|NCT03228433|EG003|Reported Event|Cohort 3A: TAK-418 30 mg Fasted|TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
11315356|NCT03228433|EG004|Reported Event|Cohort 3B: TAK-418 30 mg Fed|TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
11315357|NCT03228433|EG005|Reported Event|Cohort 4: TAK-418 40 mg|TAK-418 40 mg, capsule, orally, once on Day 1.
11315358|NCT03228433|EG006|Reported Event|Cohort 5: TAK-418 60 mg|TAK-418 60 mg, capsule, orally, once on Day 1.
11315359|NCT03228836|BG000|Baseline|Sintilimab (IBI308)|Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
11315360|NCT03228836|FG000|Participant Flow|Sintilimab (IBI308)|Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg intravenous infusion (IV) every 3 weeks (Q3W).
11315361|NCT03228836|OG000|Outcome|Sintilimab (IBI308)|Participants with relapsed or refractory ENKTL-NT were enrolled to receive sintilimab (IBI308) 200mg IV Q3W.
11315362|NCT03228836|EG000|Reported Event|Sintilimab (IBI308)|Sintilimab (IBI308) 200mg IV Q3W
11315363|NCT03228914|BG000|Baseline|All Participants|"Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into one side of the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the other side of the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315364|NCT03228914|FG000|Participant Flow|Oxymetazoline|"Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Oxymetazoline: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315365|NCT03228914|FG001|Participant Flow|Epinephrine|"Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Epinephrine: Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315366|NCT03228914|OG000|Outcome|Oxymetazoline|"Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Oxymetazoline: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315367|NCT03228914|OG001|Outcome|Epinephrine|"Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Epinephrine: Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315368|NCT03228914|EG000|Reported Event|Oxymetazoline|"Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Oxymetazoline: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315369|NCT03228914|EG001|Reported Event|Epinephrine|"Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.~Epinephrine: Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus."
11315370|NCT03229109|BG000|Baseline|Group 1|Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315371|NCT03229109|BG001|Baseline|Group 2|Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315372|NCT03229109|BG002|Baseline|Group 3|Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315373|NCT03229109|BG003|Baseline|Group 4|Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315374|NCT03229109|BG004|Baseline|Total|Total of all reporting groups
11315375|NCT03229109|FG000|Participant Flow|Group 1|Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315376|NCT03229109|FG001|Participant Flow|Group 2|Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315377|NCT03229109|FG002|Participant Flow|Group 3|Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315378|NCT03229109|FG003|Participant Flow|Group 4|Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315379|NCT03229109|OG000|Outcome|Group 1|Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315380|NCT03229109|OG001|Outcome|Group 2|Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315381|NCT03229109|OG002|Outcome|Group 3|Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315382|NCT03229109|OG003|Outcome|Group 4|Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
11315383|NCT03229109|EG000|Reported Event|Age 18-25|Spectrophon dehydration body monitor was attached to subject's wrist
11315384|NCT03229109|EG001|Reported Event|Age 26-35|Spectrophon dehydration body monitor was attached to subject's wrist
11315385|NCT03229109|EG002|Reported Event|Age 36-45|Spectrophon dehydration body monitor was attached to subject's wrist
11315386|NCT03229109|EG003|Reported Event|Age 46-50|Spectrophon dehydration body monitor was attached to subject's wrist
11315387|NCT03229252|BG000|Baseline|Placebo|"Placebo Inhalation solution twice daily for 28 days.~Placebo Inhalation Solution: Normal Saline Inhalation Solution"
11315388|NCT03229252|BG001|Baseline|SPX-101 Low Dose (60mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315389|NCT03229252|BG002|Baseline|SPX-101 High Dose (120mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315390|NCT03229252|BG003|Baseline|Total|Total of all reporting groups
11315391|NCT03229252|FG000|Participant Flow|Placebo|"Placebo Inhalation solution twice daily for 28 days.~Placebo Inhalation Solution: Normal Saline Inhalation Solution"
11315392|NCT03229252|FG001|Participant Flow|SPX-101 Low Dose (60mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315393|NCT03229252|FG002|Participant Flow|SPX-101 High Dose (120mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315394|NCT03229252|OG000|Outcome|Placebo|"Placebo Inhalation solution twice daily for 28 days.~Placebo Inhalation Solution: Normal Saline Inhalation Solution"
11315395|NCT03229252|OG001|Outcome|SPX-101 Low Dose (60mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315396|NCT03229252|OG002|Outcome|SPX-101 High Dose (120mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315397|NCT03229252|EG000|Reported Event|Placebo|"Placebo Inhalation solution twice daily for 28 days.~Placebo Inhalation Solution: Normal Saline Inhalation Solution"
11315398|NCT03229252|EG001|Reported Event|SPX-101 Low Dose (60mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11315399|NCT03229252|EG002|Reported Event|SPX-101 High Dose (120mg BID)|"Inhalation solution twice daily for 28 days.~SPX-101: SPX-101 Inhalation Solution"
11217907|NCT02317575|FG001|Participant Flow|Part A Sequence 2, ABDRC|Period 1: LY900014 Test A, Period 2: LY900014 Test B, Period 3: LY900014 Test D, Period 4: Reference (R) = insulin lispro, Period 5: LY900014 Test C
11217908|NCT02317575|FG002|Participant Flow|Part A Sequence 3, BCRAD|Period 1: LY900014 Test B, Period 2: LY900014 Test C, Period 3: Reference (R) = insulin lispro, Period 4: LY900014 Test A, Period 5: LY900014 Test D
11217909|NCT02317575|FG003|Participant Flow|Part A Sequence 4, DRBCA|Period 1: LY900014 Test D, Period 2: Reference (R) = insulin lispro, Period 3: LY900014 Test B, Period 4: LY900014 Test C, Period 5: LY900014 Test A
11217910|NCT02317575|FG004|Participant Flow|Part A Sequence 5, RACDB|Period 1: Reference (R) = insulin lispro, Period 2: LY900014 Test A, Period 3: LY900014 Test C, Period 4: LY900014 Test D, Period 5: LY900014 Test B
11217911|NCT02317575|OG000|Outcome|Part A: Formulation A, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217912|NCT02317575|OG001|Outcome|Part A: Formulation B, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217913|NCT02317575|OG002|Outcome|Part A: Formulation C, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217914|NCT02317575|OG003|Outcome|Part A: Formulation D, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217915|NCT02317575|OG004|Outcome|Part A: Reference|15 U of insulin lispro administered subcutaneously (SC) in one of five periods
11217916|NCT02317575|OG000|Outcome|Part A: Formulation A, LY900014|15 U LY900014 administered SC in one of five periods
11217917|NCT02317575|OG001|Outcome|Part A: Formulation B, LY900014|15 U LY900014 administered SC in one of five periods
11217918|NCT02317575|OG002|Outcome|Part A: Formulation C, LY900014|115 U LY900014 administered SC in one of five periods
11217919|NCT02317575|OG003|Outcome|Part A: Formulation D, LY900014|15 U LY900014 administered SC in one of five periods
11217920|NCT02317575|OG002|Outcome|Part A: Formulation C, LY900014|15 U LY900014 administered SC in one of five periods
11217921|NCT02317575|OG000|Outcome|Part B:LY900014|Formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.
11217922|NCT02317575|EG000|Reported Event|Part A: Formulation A, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217923|NCT02317575|EG001|Reported Event|Part A: Formulation B, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217924|NCT02317575|EG002|Reported Event|Part A: Forumulation C, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217925|NCT02317575|EG003|Reported Event|Part A: Forumulation D, LY900014|Single dose LY900014 administered subcutaneously (SC) in one of five periods
11217926|NCT02317575|EG004|Reported Event|Part A: Reference|15 U insulin lispro administered subcutaneously (SC)
11217927|NCT02317614|BG000|Baseline|SteadyRx|"This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.~SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load."
11217928|NCT02317614|BG001|Baseline|Usual Care|This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
11217929|NCT02317614|BG002|Baseline|Total|Total of all reporting groups
11217930|NCT02317614|FG000|Participant Flow|SteadyRx|"This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.~SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load."
11217931|NCT02317614|FG001|Participant Flow|Usual Care|This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
11217932|NCT02317614|OG000|Outcome|SteadyRx|"This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.~SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load."
11217933|NCT02317614|OG001|Outcome|Usual Care|This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
11315400|NCT03229486|BG000|Baseline|Sugammadex|"reversal of neuromuscular blockade with sugammadex~Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe."
11315401|NCT03229486|BG001|Baseline|Neostigmine|"reversal of neuromuscular blockade with neostigmine & glycopyrrolate~Neostigmine+Glycopyrronium: Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe."
11315402|NCT03229486|BG002|Baseline|Total|Total of all reporting groups
11315403|NCT03229486|FG000|Participant Flow|Sugammadex|"reversal of neuromuscular blockade with sugammadex~Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe."
11315404|NCT03229486|FG001|Participant Flow|Neostigmine|"reversal of neuromuscular blockade with neostigmine & glycopyrrolate~Neostigmine+Glycopyrronium: Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe."
11315405|NCT03229486|OG000|Outcome|Sugammadex|"reversal of neuromuscular blockade with sugammadex~Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe."
11315406|NCT03229486|OG001|Outcome|Neostigmine|"reversal of neuromuscular blockade with neostigmine & glycopyrrolate~Neostigmine+Glycopyrronium: Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe."
11315407|NCT03229486|EG000|Reported Event|Sugammadex|"reversal of neuromuscular blockade with sugammadex~Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe."
11315408|NCT03229486|EG001|Reported Event|Neostigmine|"reversal of neuromuscular blockade with neostigmine & glycopyrrolate~Neostigmine+Glycopyrronium: Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe."
11315409|NCT03229759|BG000|Baseline|Participants Treated|Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, baseline data are presented for all treated participants and not by treatment arm.
11315410|NCT03229759|FG000|Participant Flow|All Participants|All screened participants
11315411|NCT03229759|OG000|Outcome|Investigational Product|Investigational Product (IP) - Thermally treated polyester cloths impregnated with 0.4% weight by volume octenidine dihydrochloride (OCT) aqueous solution
11315412|NCT03229759|OG001|Outcome|Saline Control|Saline Control (SC) - 0.9% saline applied with polyester cloths
11315413|NCT03229759|OG002|Outcome|Vehicle Control|Vehicle Control (VC) Thermally treated polyester cloths impregnated with vehicle formulation.
11315414|NCT03229759|EG000|Reported Event|Subject Treated|Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, adverse event data are presented for all treated participants and not by treatment arm.
11315415|NCT03230175|BG000|Baseline|TTAX01 Plus Standard Care|"Eligible consenting subjects underwent a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue.~TTAX01: TTAX01 was applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article covered the entire open surface of the wound. The material was applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.~Surgical resection and debridement: Perform surgical sharp debridement in the OR, to remove:~infectious agents and biofilms (purulence),~all debris, eschar, callus and macerated non-viable tissue from the wound base, and~dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.~Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.~Systemic antibiotics: Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.~Off-loading: Provide off-loading device appropriate to the location of wound with full length boot or total contact cast"
11315416|NCT03230175|FG000|Participant Flow|TTAX01 Plus Standard Care|"Eligible consenting subjects underwent a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. infection.~TTAX01: TTAX01 was applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article covered the entire open surface of the wound. The material was to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.~Surgical resection and debridement: Perform surgical sharp debridement in the OR, to remove:~infectious agents and biofilms (purulence),~all debris, eschar, callus and macerated non-viable tissue from the wound base, and~dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.~Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.~Systemic antibiotics: Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.~Off-loading: Provide off-loading device appropriate to the location of wound with full length boot or total contact cast"
11335891|NCT03558230|EG001|Reported Event|No Vibration|"The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.~Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.~Placebo (for vibration): No vibration applied to the wrist.~The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose."
11315417|NCT03230175|OG000|Outcome|TTAX01 Plus Standard Care|"Eligible consenting subjects underwent a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue.~TTAX01: TTAX01 was applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article covered the entire open surface of the wound. The material was applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it was replaced at any time.~Surgical resection and debridement: Performed surgical sharp debridement in the OR, to remove:~infectious agents and biofilms (purulence),~all debris, eschar, callus and macerated non-viable tissue from the wound base, and~dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.~Surgical Resection performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.~Systemic antibiotics: Six (6) weeks of systemic antibiotic therapy was required. A definitive therapy was guided by the microbiological results based on bone biopsy.~Off-loading: Provided off-loading device appropriate to the location of wound with full length boot or total contact cast"
11315418|NCT03230175|EG000|Reported Event|TTAX01 Plus Standard Care|"Eligible consenting subjects underwent a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue.~TTAX01: TTAX01 was applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article covered the entire open surface of the wound. The material was applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it was replaced at any time.~Surgical resection and debridement: Performed surgical sharp debridement in the OR, to remove:~infectious agents and biofilms (purulence),~all debris, eschar, callus and macerated non-viable tissue from the wound base, and~dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.~Surgical Resection performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.~Systemic antibiotics: Six (6) weeks of systemic antibiotic therapy was required. A definitive therapy was guided by the microbiological results based on bone biopsy.~Off-loading: Provided off-loading device appropriate to the location of wound with full length boot or total contact cast"
11315419|NCT03230864|BG000|Baseline|Non-randomized Patients|Patients not randomized to double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm, independent of treatment
11315420|NCT03230864|BG001|Baseline|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 8 weeks
11315421|NCT03230864|BG002|Baseline|DBT, Continued Treatment From PC Period|Patients in this arm continued with the same treatment and dose as at the last visit of the PC period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
11315422|NCT03230864|BG003|Baseline|Total|Total of all reporting groups
11315423|NCT03230864|FG000|Participant Flow|Prospective Confirmation (PC) Period, Risperidone|"Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks~Risperidone: 4-6 mg/day, encapsulated tablets, orally"
11315424|NCT03230864|FG001|Participant Flow|PC Period, Olanzapine|"Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks~Olanzapine: 15-20 mg/day, encapsulated tablets, orally"
11315425|NCT03230864|FG002|Participant Flow|Double-blind (DBT), Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 8 weeks
11315426|NCT03230864|FG003|Participant Flow|DBT, Continued Treatment From PC Period|Patients in this arm will continue the treatment allocated in the PC period at the dose set at the last visit of the PC period. The analysis is made independent on which treatment the patient was done (risperidone or olanzapine). 8 weeks treatment.
11315427|NCT03230864|OG000|Outcome|Double-blind Treatment (DBT) Period, Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 8 weeks
11315428|NCT03230864|OG001|Outcome|DBT, Continued Treatment From PC Period|Patients in this arm will continue on the same treatment and dose as at the last visit of the PC period (olanzapine or risperidone)
11315429|NCT03230864|OG000|Outcome|DBT, Lu AF35700 10 mg|"10 mg encapsulated tablets administered orally, once daily.~Lu AF35700: 10 mg/day, encapsulated tablets, orally"
11315430|NCT03230864|OG001|Outcome|DBT, Continued Treatment|Patients in this arm will continue on the same treatment and dose as at the last visit of the PC period (olanzapine or risperidone)
11315431|NCT03230864|EG000|Reported Event|Prospective Confirmation (PC) Period - Risperidone|Patients not randomized to double-blind treatment
11315432|NCT03230864|EG001|Reported Event|PC Period - Olanzapine|Patients not randomized to double-blind treatment
11315433|NCT03230864|EG002|Reported Event|Double Blind Treatment (DBT) Period - Lu AF35700 10 mg|Lu AF35700: 10 mg/day, encapsulated tablets, orally for 8 weeks
11315434|NCT03230864|EG003|Reported Event|DBT Period, Continued Treatment From PC Period|Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone for 8 weeks).
11315435|NCT03231228|BG000|Baseline|Cefazolin 1 g Infusion|"Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.~Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg"
11315436|NCT03231228|BG001|Baseline|Cefazolin 2 g Infusion|"Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.~Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg"
11315437|NCT03231228|BG002|Baseline|Total|Total of all reporting groups
11315438|NCT03231228|FG000|Participant Flow|Cefazolin 1 g Infusion|"Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.~Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg"
11315439|NCT03231228|FG001|Participant Flow|Cefazolin 2 g Infusion|"Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.~Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg"
11315440|NCT03231228|OG000|Outcome|Cefazolin 1 g Infusion|"Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.~Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg"
11315441|NCT03231228|OG001|Outcome|Cefazolin 2 g Infusion|"Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.~Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg"
11315442|NCT03231228|EG000|Reported Event|Cefazolin 1 g Infusion|"Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.~Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg"
11315443|NCT03231228|EG001|Reported Event|Cefazolin 2 g Infusion|"Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.~Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg"
11315444|NCT03231345|BG000|Baseline|US Guided IJ|"A physician placed ultrasound-guided IV in the internal jugular vein~US guided IJ: IV catheter placement~Ultrasound: Ultrasound-guided Internal Jugular vein"
11315445|NCT03231345|FG000|Participant Flow|US Guided IJ|"A physician placed ultrasound-guided IV in the internal jugular vein~US guided IJ: IV catheter placement~Ultrasound: Ultrasound-guided Internal Jugular vein"
11315446|NCT03231345|OG000|Outcome|US Guided IJ|"A physician placed ultrasound-guided IV in the internal jugular vein~US guided IJ: IV catheter placement~Ultrasound: Ultrasound-guided Internal Jugular vein"
11315447|NCT03231345|EG000|Reported Event|US Guided IJ|"A physician placed ultrasound-guided IV in the internal jugular vein~US guided IJ: IV catheter placement~Ultrasound: Ultrasound-guided Internal Jugular vein"
11315448|NCT03231371|BG000|Baseline|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
11315449|NCT03231371|FG000|Participant Flow|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
11315450|NCT03231371|OG000|Outcome|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
11315451|NCT03231371|EG000|Reported Event|Study Arm|Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
11315452|NCT03231709|BG000|Baseline|Trelagliptin 100 mg + Alogliptin 25 mg|Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.
11315453|NCT03231709|BG001|Baseline|Alogliptin 25 mg + Trelagliptin 100 mg|Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
11315454|NCT03231709|BG002|Baseline|Total|Total of all reporting groups
11315455|NCT03231709|FG000|Participant Flow|Trelagliptin 100 mg + Alogliptin 25 mg|Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.
11315456|NCT03231709|FG001|Participant Flow|Alogliptin 25 mg + Trelagliptin 100 mg|Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
11315457|NCT03231709|OG000|Outcome|Trelagliptin 100 mg + Alogliptin 25 mg|Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.
11315458|NCT03231709|OG001|Outcome|Alogliptin 25 mg + Trelagliptin 100 mg|Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
11315459|NCT03231709|OG000|Outcome|Either Trelagliptin or Alogliptin|Participants who prefer either trelagliptin 100 mg, tablets, once a week or alogliptin 25 mg, tablets once a day.
11315460|NCT03231709|OG001|Outcome|Trelagliptin Preference|Participants who prefer trelagliptin 100 mg, tablets, once a week.
11315461|NCT03231709|OG002|Outcome|Alogliptin Preference|Participants who prefer alogliptin 25 mg, tablets, once a day.
11315462|NCT03231709|OG003|Outcome|Neither Trelagliptin Nor Alogliptin|Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
11315463|NCT03231709|EG000|Reported Event|Trelagliptin 100 mg|Trelagliptin 100 mg tablets, orally, once a week for 8 weeks in either Period 1 or 2.
11315464|NCT03231709|EG001|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg tablets, orally, once a day for 8 weeks in either Period 1 or 2.
11315465|NCT03231800|BG000|Baseline|Placebo|Placebo capsule
11315466|NCT03231800|BG001|Baseline|Dasotraline|Dasotraline capsule 2mg/day
11315467|NCT03231800|BG002|Baseline|Total|Total of all reporting groups
11315468|NCT03231800|FG000|Participant Flow|Placebo|Placebo capsule
11315469|NCT03231800|FG001|Participant Flow|Dasotraline|Dasotraline capsule 2mg/day
11315470|NCT03231800|OG000|Outcome|Placebo|Placebo capsule
11315471|NCT03231800|OG001|Outcome|Dasotraline|Dasotraline capsule 2mg/day
11315472|NCT03231800|EG000|Reported Event|Placebo|Placebo capsule
11315473|NCT03231800|EG001|Reported Event|Dasotraline|Dasotraline capsule 2mg/day
11315474|NCT03231917|BG000|Baseline|Water Infusion First|"In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.~Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation."
11315475|NCT03231917|BG001|Baseline|CO2 Insufflation First|"In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.~CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion ."
11315476|NCT03231917|BG002|Baseline|Total|Total of all reporting groups
11315477|NCT03231917|FG000|Participant Flow|Water Infusion First|"In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.~Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation."
11315478|NCT03231917|FG001|Participant Flow|CO2 Insufflation First|"In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.~CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion ."
11315479|NCT03231917|OG000|Outcome|Water Infusion First|"In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.~Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation."
11315480|NCT03231917|OG001|Outcome|CO2 Insufflation First|"In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.~CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion ."
11315481|NCT03231917|EG000|Reported Event|Water Infusion First|"In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.~Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation."
11315482|NCT03231917|EG001|Reported Event|CO2 Insufflation First|"In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.~CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion ."
11315483|NCT03231943|BG000|Baseline|Part 1: Cohort 1|Participants received GSK3640254 1mg, GSK3640254 10 mg, GSK3640254 100mg, GSK3640254 400mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
11315484|NCT03231943|BG001|Baseline|Part 1: Cohort 2|Participants received GSK3640254 3mg, GSK3640254 30 mg, GSK3640254 200mg, GSK3640254 700mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
11315485|NCT03231943|BG002|Baseline|Part 2: Repeated Dose GSK3640254 50 mg|Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
11315486|NCT03231943|BG003|Baseline|Part 2: Repeated Dose GSK3640254 100 mg|Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
11315487|NCT03231943|BG004|Baseline|Part 2: Repeated Dose GSK3640254 200 mg + Expansion|Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
11315488|NCT03231943|BG005|Baseline|Part 2: Repeated Dose GSK3640254 320 mg|Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
11315489|NCT03231943|BG006|Baseline|Part 2: Repeated Dose Placebo|Participants received repeated dose of matching placebo once daily up to 14 days
11315490|NCT03231943|BG007|Baseline|Total|Total of all reporting groups
11315491|NCT03231943|FG000|Participant Flow|Part 1: Placebo Followed by GSK3640254 10mg/100mg/400mg|Participants received single dose placebo followed by GSK3640254 10 milligram (mg) followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
11315492|NCT03231943|FG001|Participant Flow|Part 1: GSK3640254 1mg/ Placebo /100 mg/400 mg|Participants received single dose GSK3640254 1mg followed by placebo followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
11315493|NCT03231943|FG002|Participant Flow|Part 1: GSK3640254 1mg/10mg/Placebo /400mg|Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by placebo followed by GSK3640254 400 mg oral dose on Day 1
11315494|NCT03231943|FG003|Participant Flow|Part 1: GSK3640254 1mg/10mg/100mg/Placebo|Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by GSK3640254 100 mg followed by placebo as oral dose on Day 1
11315495|NCT03231943|FG004|Participant Flow|Part 1: Placebo/ GSK3640254 30mg/200 mg/700 mg|Participants received single dose placebo followed by GSK3640254 30mg followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
11315496|NCT03231943|FG005|Participant Flow|Part1:GSK3640254 3mg/Placebo/200mg/700mg|Participants received single dose GSK3640254 3mg followed by placebo followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
11315497|NCT03231943|FG006|Participant Flow|Part 1:GSK3640254 3mg/30mg/Placebo/GSK3640254 700mg|Participants received single dose GSK3640254 3 mg followed by GSK3640254 30 mg followed by placebo followed by GSK3640254 700 mg as oral dose on Day 1
11315498|NCT03231943|FG007|Participant Flow|Part 1:GSK3640254 3mg/30mg/GSK3640254 200mg/Placebo|Participants received single dose GSK3640254 3mg followed by GSK3640254 30mg followed by GSK3640254 200mg followed by placebo as oral dose on Day 1
11315499|NCT03231943|FG008|Participant Flow|Part 2: Repeated Dose GSK3640254 50 mg|Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
11315500|NCT03231943|FG009|Participant Flow|Part 2: Repeated Dose GSK3640254 100mg|Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
11315501|NCT03231943|FG010|Participant Flow|Part 2: GSK3640254 200mg + Expansion|Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
11315502|NCT03231943|FG011|Participant Flow|Part 2: Repeated Dose GSK3640254 320mg|Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
11315503|NCT03231943|FG012|Participant Flow|Part 2: Repeated Dose Placebo|Participants received repeated dose of matching placebo once daily up to 14 days
11315504|NCT03231943|OG000|Outcome|Part 1: GSK3640254 1 mg|Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
11315505|NCT03231943|OG001|Outcome|Part 1: GSK3640254 3 mg|Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
11315506|NCT03231943|OG002|Outcome|Part 1: GSK3640254 10 mg|Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
11315507|NCT03231943|OG003|Outcome|Part 1: GSK3640254 30mg|Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
11315508|NCT03231943|OG004|Outcome|Part 1: GSK3640254 100 mg|Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
11315509|NCT03231943|OG005|Outcome|Part 1: GSK3640254 200 mg|Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
11315510|NCT03231943|OG006|Outcome|Part 1: GSK3640254 400 mg|Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
11315511|NCT03231943|OG007|Outcome|Part 1: GSK3640254 700 mg|Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
11315512|NCT03231943|OG008|Outcome|Part 1: Single Dose Placebo|Participants received single dose of matching placebo following a moderate fat meal on Day 1
11315513|NCT03231943|OG000|Outcome|Part 2: GSK3640254 50 mg|Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
11315514|NCT03231943|OG001|Outcome|Part 2: GSK3640254 100 mg|Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
11315515|NCT03231943|OG002|Outcome|Part 2: GSK3640254 200 mg + Expansion|Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
11315516|NCT03231943|OG003|Outcome|Part 2: GSK3640254 320 mg|Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
11315517|NCT03231943|OG004|Outcome|Part 2: Repeated Dose Placebo|Participants received repeated dose of matching placebo once daily up to 14 days
11315518|NCT03231943|EG000|Reported Event|Part 1:GSK3640254 1 mg|Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
11315519|NCT03231943|EG001|Reported Event|Part 1:GSK3640254 3 mg|Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
11315520|NCT03231943|EG002|Reported Event|Part 1:GSK3640254 10 mg|Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
11315521|NCT03231943|EG003|Reported Event|Part 1:GSK3640254 30 mg|Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
11315522|NCT03231943|EG004|Reported Event|Part 1:GSK3640254 100 mg|Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
11315523|NCT03231943|EG005|Reported Event|Part 1:GSK3640254 200 mg|Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
11315524|NCT03231943|EG006|Reported Event|Part 1:GSK3640254 400 mg|Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
11315525|NCT03231943|EG007|Reported Event|Part 1:GSK3640254 700 mg|Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
11315526|NCT03231943|EG008|Reported Event|Part 1: Single Dose Placebo|Participants received single dose of matching placebo following a moderate fat meal on Day 1
11315527|NCT03231943|EG009|Reported Event|Part 2: Repeated Dose GSK3640254 50 mg|Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
11315528|NCT03231943|EG010|Reported Event|Part 2: Repeated Dose GSK3640254 100 mg|Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
11315529|NCT03231943|EG011|Reported Event|Part 2: Repeated Dose GSK3640254 200mg +Expansion|Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
11315530|NCT03231943|EG012|Reported Event|Part 2: Repeated Dose GSK3640254 320 mg|Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
11315531|NCT03231943|EG013|Reported Event|Part 2: Repeated Dose Placebo|Participants received repeated dose of matching placebo once daily up to 14 days
11315532|NCT03231969|BG000|Baseline|Bilastine 0.2%|Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
11315533|NCT03231969|BG001|Baseline|Bilastine 0.4%|Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
11315534|NCT03231969|BG002|Baseline|Bilastine 0.6%|Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
11315535|NCT03231969|BG003|Baseline|Bilastine 0%|Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
11315536|NCT03231969|BG004|Baseline|Total|Total of all reporting groups
11315537|NCT03231969|FG000|Participant Flow|Bilastine 0.2%|Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
11315538|NCT03231969|FG001|Participant Flow|Bilastine 0.4%|Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
11315539|NCT03231969|FG002|Participant Flow|Bilastine 0.6%|Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
11315540|NCT03231969|FG003|Participant Flow|Bilastine 0%|Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
11315541|NCT03231969|OG000|Outcome|Bilastine 0.2%|Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
11315542|NCT03231969|OG001|Outcome|Bilastine 0.4%|Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
11315543|NCT03231969|OG002|Outcome|Bilastine 0.6%|Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
11315544|NCT03231969|OG003|Outcome|Bilastine 0% (Vehicle)|Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period
11315545|NCT03231969|EG000|Reported Event|Bilastine 0.2%|Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
11315546|NCT03231969|EG001|Reported Event|Bilastine 0.4%|Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
11315547|NCT03231969|EG002|Reported Event|Bilastine 0.6%|Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
11315548|NCT03231969|EG003|Reported Event|Bilastine 0%|Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
11315549|NCT03232281|BG000|Baseline|Triptorelin Pamoate PR 3-month|Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
11315550|NCT03232281|BG001|Baseline|Triptorelin Acetate PR 1-month|Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
11315551|NCT03232281|BG002|Baseline|Total|Total of all reporting groups
11315552|NCT03232281|FG000|Participant Flow|Triptorelin Pamoate PR 3-month|Subjects received 15 milligrams (mg) triptorelin pamoate per injection, administered as an intramuscular (IM) injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
11315553|NCT03232281|FG001|Participant Flow|Triptorelin Acetate PR 1-month|Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
11315554|NCT03232281|OG000|Outcome|Triptorelin Pamoate PR 3-month|Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
11315555|NCT03232281|OG001|Outcome|Triptorelin Acetate PR 1-month|Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
11315556|NCT03232281|EG000|Reported Event|Triptorelin Pamoate PR 3-month|Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
11315557|NCT03232281|EG001|Reported Event|Triptorelin Acetate PR 1-month|Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
11315558|NCT03232333|BG000|Baseline|MIRODERM|Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
11315559|NCT03232333|FG000|Participant Flow|MIRODERM|Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
11315560|NCT03232333|OG000|Outcome|MIRODERM|Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
11315561|NCT03232333|EG000|Reported Event|MIRODERM|Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
11315562|NCT03232567|BG000|Baseline|NasoVAX Low Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^9viral particles (vp)
11315563|NCT03232567|BG001|Baseline|NasoVAX Medium Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp)
11315564|NCT03232567|BG002|Baseline|NasoVAX High Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp)
11315565|NCT03232567|BG003|Baseline|Placebo|Normal saline administered by intranasal spray at a single dose
11315566|NCT03232567|BG004|Baseline|Total|Total of all reporting groups
11315567|NCT03232567|FG000|Participant Flow|NasoVAX Low Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp)
11315568|NCT03232567|FG001|Participant Flow|NasoVAX Medium Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp)
11315569|NCT03232567|FG002|Participant Flow|NasoVAX High Dose|NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp)
11315570|NCT03232567|FG003|Participant Flow|Placebo|Normal saline administered by intranasal spray at a single dose
11315571|NCT03232567|OG000|Outcome|NasoVAX Low Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315572|NCT03232567|OG001|Outcome|NasoVAX Medium Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315573|NCT03232567|OG002|Outcome|NasoVAX High Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315574|NCT03232567|OG003|Outcome|Placebo|Normal saline administered by intranasal spray at a single dose
11315575|NCT03232567|EG000|Reported Event|NasoVAX Low Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315576|NCT03232567|EG001|Reported Event|NasoVAX Medium Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315577|NCT03232567|EG002|Reported Event|NasoVAX High Dose|"NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo~NasoVAX: Single ascending dose study"
11315578|NCT03232567|EG003|Reported Event|Placebo|Normal saline administered
11315579|NCT03232580|BG000|Baseline|rhAnnexin V-128|All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
11315580|NCT03232580|FG000|Participant Flow|rhAnnexin V-128|All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
11315581|NCT03232580|OG000|Outcome|rhAnnexin V-128|All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
11315582|NCT03232580|EG000|Reported Event|rhAnnexin V-128|All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
11315583|NCT03232645|BG000|Baseline|Rhythmia HDx and DirectSense Technology|"Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.~For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.~Ablation procedure: Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter"
11333335|NCT03512041|OG000|Outcome|RLIC - 5 Cycles|"Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants underg"
11315584|NCT03232645|FG000|Participant Flow|Rhythmia HDx and DirectSense Technology|"Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.~For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.~Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.~Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI."
11315585|NCT03232645|OG000|Outcome|Rhythmia HDx and DirectSense Technology|"Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.~For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.~Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.~Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI."
11315586|NCT03232645|OG000|Outcome|Rhythmia HDx and DirectSense Technology|"Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.~For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.~Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter"
11315587|NCT03232645|EG000|Reported Event|Rhythmia HDx and DirectSense Technology|"Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.~For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.~Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.~Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI."
11315588|NCT03232749|BG000|Baseline|Symptomatic Primary Osteoarthritis of the Shoulder|"Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder~intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered~corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder~Ultrasound: ultrasound-guided IACSI"
11315589|NCT03232749|FG000|Participant Flow|Symptomatic Primary Osteoarthritis of the Shoulder|"Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder~intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered~corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder~Ultrasound: ultrasound-guided IACSI"
11315590|NCT03232749|OG000|Outcome|Symptomatic Primary Osteoarthritis of the Shoulder|"Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder~intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered~corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder~Ultrasound: ultrasound-guided IACSI"
11335892|NCT03558516|BG000|Baseline|Group NSS|The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335893|NCT03558516|BG001|Baseline|Group Mg|The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335894|NCT03558516|BG002|Baseline|Total|Total of all reporting groups
11315591|NCT03232749|EG000|Reported Event|Symptomatic Primary Osteoarthritis of the Shoulder|"Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder~intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered~corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder~Ultrasound: ultrasound-guided IACSI"
11315592|NCT03232827|BG000|Baseline|All Study Participants|Participants completed up to 4 smoking sessions and were randomized to 1 of 36 session sequences: 1) FS - UU - US, 2) UU - FS - US, 3) US - UU - FS, 4) FS - US - UU, 5) US - FS - UU, 6) UU - US - FS, 7) UU - FU - US - FS, 8) UU - FU - FS - US, 9) UU - US - FS - FU, 10) UU - US - FU - FS, 11) UU - FS - US - FU, 12) UU - FS - FU - US, 13) FU - UU - US - FS, 14) FU - UU - FS - US, 15) FU - US - FS - UU, 16) FU - US - UU - FS, 17) FU - FS - UU - US, 18) FU - FS - US - UU, 19) US - UU - FU - FS, 20) US - UU - FS - FU, 21) US - FU - UU - FS, 22) US - FU - FS - UU, 23) US - FS - UU - FU, 24) US - FS - FU - UU, 25) FS - UU - FU - US, 26) FS - UU - US - FU, 27) FS - FU - UU - US, 28) FS - FU - US - UU, 29) FS - US - FU - UU, 30) FS - US - UU - FU, 31) UU - FU - FS - US, 32) FS - UU - FU - US, 33) FU - FS - US - UU, 34) US - UU - FS - FU, 35) FU - US - UU - FS, 36) UU - US - FU - FS. A fourth arm (FU) was added to the study one month after the study started.
11315593|NCT03232827|FG000|Participant Flow|All Interventions|Participants will be randomized and complete study procedures in self-selected dyads. The sessions will be counterbalanced and include: 1) smoking preferred flavored-sweetened WP tobacco 2) smoking unflavored-sweetened WP Tobacco and 3) smoking preferred flavored-very low sweetened WP tobacco and 4) smoking unflavored-very low sweetened WP tobacco. Participants will complete all four study visits in the laboratory. Pre-session abstinence from tobacco for at least 12 hours will be mandatory for all participants. Abstinence will be confirmed via participant self-report and an exhaled carbon monoxide monitor (< 20 ppm) for tobacco use. Participant dyads will first complete a 10-minute puffing session separated by 30-second intervals with the prepared hookah and then smoke ad libitum for up to 1 hour. This procedure will be completed for all visits. Participants will also complete a minimum 48-hour washout period between sessions.
11315594|NCT03232827|OG000|Outcome|Flavored-sweetened|"Flavored-sweetened (FS) WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled), highest abuse potential, and greatest levels of exposure to nicotine and carbon monoxide (CO). , followed by unflavored-sweetened WP, and lastly unflavored-very low sweetened WP. (H1d) A majority of WP smokers will report having initiated WP smoking with flavored-sweetened tobacco and report flavoring as an important reason for trying WP.~Flavored-Sweetened Waterpipe Tobacco: Pre-weighed flavored-sweetened waterpipe tobacco will be prepared."
11315595|NCT03232827|OG001|Outcome|Unflavored-sweetened|"Unflavored-sweetened (US) WP will be associated with the second longest and slightly less frequent puffing than FS resulting in the second greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Unflavored-sweetened waterpipe tobacco: Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared."
11315596|NCT03232827|OG002|Outcome|Unflavored Very Low Sweetened|"Unflavored-very low sweetened (UU) WP will be associated with the shortest and the least frequent puffing resulting in the least overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Unflavored-very low sweetened waterpipe tobacco: Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared."
11315597|NCT03232827|OG003|Outcome|Flavored-very Low Sweetened Waterpipe|"Flavored-very low sweetened WP will be associated with the third longest and slightly less frequent puffing than US resulting in the third greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Flavored-very low sweetened waterpipe: Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared."
11315598|NCT03232827|EG000|Reported Event|Flavored Sweetened|Flavored-sweetened (FS) WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled), highest abuse potential, and greatest levels of exposure to nicotine and carbon monoxide (CO). , followed by unflavored-sweetened WP, and lastly unflavored-very low sweetened WP. (H1d) A majority of WP smokers will report having initiated WP smoking with flavored-sweetened tobacco and report flavoring as an important reason for trying WP.
11315599|NCT03232827|EG001|Reported Event|Unflavored Sweetened|"Unflavored-sweetened (US) WP will be associated with the second longest and slightly less frequent puffing than FS resulting in the second greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Unflavored-sweetened waterpipe tobacco: Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared."
11315600|NCT03232827|EG002|Reported Event|Unflavored Very Low Sweetened|"Unflavored-very low sweetened (UU) WP will be associated with the shortest and the least frequent puffing resulting in the least overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Unflavored-very low sweetened waterpipe tobacco: Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared."
11315601|NCT03232827|EG003|Reported Event|Flavored-very Low Sweetened Waterpipe|"Flavored-very low sweetened WP will be associated with the third longest and slightly less frequent puffing than US resulting in the third greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).~Flavored-very low sweetened waterpipe: Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared."
11315602|NCT03232983|BG000|Baseline|Overall|Single 15-U dose of LY900014 administered in treatment Period 1- 4, as SC injection into the abdomen, the thigh, the deltoid or an IV bolus injection, per randomized treatment sequence.
11315603|NCT03232983|FG000|Participant Flow|LY900014 Treatment Sequence 1: Abdomen,Thigh, Deltoid(Arm), IV|Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in Period 1, Thigh in Period 2, Deltoid (Arm) in Period 3, and single 15-U intravenous (IV) bolus injection in Period 4.
11315604|NCT03232983|FG001|Participant Flow|LY900014 Treatment Sequence 2: Deltoid, Abdomen, IV, Thigh|Single dose of 15-U of LY900014 administered SC into the: Deltoid in Period 1, Abdomen in Period 2, single 15-U IV bolus injection in Period 3, and single 15-U SC administration into the Thigh in Period 4.
11315605|NCT03232983|FG002|Participant Flow|LY900014 Treatment Sequence 3: IV, Deltoid, Thigh, Abdomen|Single 15-U IV bolus injection of LY900014 administered in Period 1, single 15-U dose administered SC in the Deltoid in Period 2, Thigh in Period 3, and Abdomen in Period 4.
11315606|NCT03232983|FG003|Participant Flow|LY900014 Treatment Sequence 4: Thigh, IV, Abdomen, Deltoid|Single dose of 15-U of LY900014 administered SC in Thigh in Period 1, single 15-U IV bolus injection in Period 2, single dose of 15-U administered SC in the Abdomen in Period 3, and Deltoid in Period 4.
11315607|NCT03232983|OG000|Outcome|LY900014 (SC Abdomen)|Single 15-U dose of LY900014 administered subcutaneously (SC) into the abdomen in one period.
11315608|NCT03232983|OG001|Outcome|LY900014 (SC Deltoid)|Single 15-U dose of LY900014 administered SC into the deltoid in one period.
11315609|NCT03232983|OG002|Outcome|LY900014 (IV)|Single 15-U injection IV bolus of LY900014 administered in one period.
11315610|NCT03232983|OG003|Outcome|LY900014 (SC Thigh)|Single 15-U dose of LY900014 administered SC into the thigh in one period.
11315611|NCT03232983|OG001|Outcome|LY900014 (SC Deltoid)|Single 15-U dose of LY900014 administered SC into the arm in one period.
11315612|NCT03232983|OG002|Outcome|LY900014 (SC Thigh)|Single 15-U dose of LY900014 administered SC into the thigh in one period.
11315613|NCT03232983|EG000|Reported Event|15-U LY900014 Abdomen|Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen.
11315614|NCT03232983|EG001|Reported Event|15-U LY900014 Thigh|Single dose of 15-U of LY900014 administered SC into the Thigh.
11315615|NCT03232983|EG002|Reported Event|15-U LY900014 Deltoid|Single dose of 15-U of LY900014 administered SC into the Deltoid.
11315616|NCT03232983|EG003|Reported Event|15-U LY900014 IV|Single 15-U LY900014 administered IV bolus injection.
11315617|NCT03233009|BG000|Baseline|Overall Participants|All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.
11315618|NCT03233009|FG000|Participant Flow|Overall Participants|All participants enrolled in the study received all the study products. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch in a randomized manner. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.
11315619|NCT03233009|OG000|Outcome|Test Product 1|This arm includes data from the test sites where test product 1 was applied.
11315620|NCT03233009|OG001|Outcome|Test Product 2|This arm includes data from the test sites where test product 2 was applied.
11315621|NCT03233009|OG002|Outcome|Test Product 3|This arm includes data from the test sites where test product 3 was applied.
11315622|NCT03233009|OG003|Outcome|Test Product 4|This arm includes data from the test sites where test product 4 was applied.
11315623|NCT03233009|OG004|Outcome|Reference Product|This arm includes data from the test sites where reference product was applied.
11315624|NCT03233009|EG000|Reported Event|Test Product 1|This arm includes data from the test sites where test product 1 was applied.
11315625|NCT03233009|EG001|Reported Event|Test Product 2|This arm includes data from the test sites where test product 2 was applied.
11315626|NCT03233009|EG002|Reported Event|Test Product 3|This arm includes data from the test sites where test product 3 was applied.
11315627|NCT03233009|EG003|Reported Event|Test Product 4|This arm includes data from the test sites where test product 4 was applied.
11315628|NCT03233009|EG004|Reported Event|Reference Product|This arm includes data from the test sites where reference product was applied.
11315629|NCT03233009|EG005|Reported Event|Overall Participants|All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule
11315630|NCT03233230|BG000|Baseline|Placebo|Participants received placebo matched to M2951 orally for 12 weeks.
11315631|NCT03233230|BG001|Baseline|M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
11315632|NCT03233230|BG002|Baseline|M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 12 weeks.
11315633|NCT03233230|BG003|Baseline|M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
11315634|NCT03233230|BG004|Baseline|Total|Total of all reporting groups
11315635|NCT03233230|FG000|Participant Flow|Placebo|Participants received placebo matched to M2951 orally for 12 weeks.
11315636|NCT03233230|FG001|Participant Flow|M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
11315637|NCT03233230|FG002|Participant Flow|M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 12 weeks.
11315638|NCT03233230|FG003|Participant Flow|M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
11315639|NCT03233230|OG000|Outcome|Placebo|Participants received placebo matched to M2951 orally for 12 weeks.
11315640|NCT03233230|OG001|Outcome|M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
11315641|NCT03233230|OG002|Outcome|M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 12 weeks.
11315642|NCT03233230|OG003|Outcome|M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
11315643|NCT03233230|EG000|Reported Event|Placebo|Participants received placebo matched to M2951 orally for 12 weeks.
11315644|NCT03233230|EG001|Reported Event|M2951 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
11315645|NCT03233230|EG002|Reported Event|M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 12 weeks.
11315646|NCT03233230|EG003|Reported Event|M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
11315647|NCT03233308|BG000|Baseline|All Randomized Patients|1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo comparator to the contralateral eye
11315648|NCT03233308|FG000|Participant Flow|All Randomized Patients|1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
11315649|NCT03233308|OG000|Outcome|Netarsudil Ophthalmic Solution 0.02%|Netarsudil Ophthalmic Solution 0.02% was administered in one eye
11315650|NCT03233308|OG001|Outcome|Placebo Comparator|Placebo Comparator administered in contralateral eye
11315651|NCT03233308|OG001|Outcome|Placebo Comparator|Placebo comparator administered in contralateral eye
11315652|NCT03233308|OG000|Outcome|Netarsudil Ophthalmic Solution 0.02%|Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo to the contralateral eye
11315653|NCT03233308|OG001|Outcome|Placebo Comparator|Placebo Comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
11315654|NCT03233308|OG000|Outcome|Netarsudil Ophthalmic Solution 0.02%|Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
11315655|NCT03233308|OG001|Outcome|Placebo Comparator|Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
11315656|NCT03233308|EG000|Reported Event|Netarsudil Ophthalmic Solution 0.02%|Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
11315657|NCT03233308|EG001|Reported Event|Placebo Comparator|Placebo comparator was administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
11315658|NCT03233438|BG000|Baseline|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11315659|NCT03233438|BG001|Baseline|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11315660|NCT03233438|BG002|Baseline|Total|Total of all reporting groups
11315661|NCT03233438|FG000|Participant Flow|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11315662|NCT03233438|FG001|Participant Flow|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11315663|NCT03233438|OG000|Outcome|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11315664|NCT03233438|OG001|Outcome|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11315665|NCT03233438|EG000|Reported Event|Usual Care|Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
11315666|NCT03233438|EG001|Reported Event|New Critical Pathway|The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
11315667|NCT03233529|BG000|Baseline|Crisaborole Ointment 2%+Vehicle, Then Crisaborole Ointment 2%|The study consisted of 2 periods, i.e., a double-blind period from Day 1 to Day 15 skin biopsy collection, and an open-label period from Day 15 skin biopsy collection to the end of study (Day 71). Each participant received double-blind topical administration of crisaborole ointment 2 percent (%) for 1 target lesion and placebo ointment vehicle (referred to as vehicle) for the other target lesion (i.e., each participant was treated with both crisaborole and vehicle), twice daily from Day 1 to Day 14; then received open-label topical administration of crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp) twice daily from Day 15 to Day 42.
11315668|NCT03233529|FG000|Participant Flow|Crisaborole Ointment 2%+Vehicle, Then Crisaborole Ointment 2%|The study consisted of 2 periods, i.e., a double-blind period from Day 1 to Day 15 skin biopsy collection, and an open-label period from Day 15 skin biopsy collection to the end of study (Day 71). Each participant received double-blind topical administration of crisaborole ointment 2 percent (%) for 1 target lesion and placebo ointment vehicle (referred to as vehicle) for the other target lesion (i.e., each participant was treated with both crisaborole and vehicle), twice daily from Day 1 to Day 14; then received open-label topical administration of crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp) twice daily from Day 15 to Day 42.
11315669|NCT03233529|OG000|Outcome|Crisaborole Ointment 2% Treated Lesion|On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
11315670|NCT03233529|OG001|Outcome|Vehicle Treated Lesion|On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
11315671|NCT03233529|OG000|Outcome|Crisaborole Ointment 2% + Vehicle in Double-Blind Period|On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the participants who were treated with both crisaborole ointment 2% and vehicle during Days 1 to 14.
11315672|NCT03233529|OG001|Outcome|Crisaborole Ointment 2% in Open-Label Period|On Days 15 to 42, each participant received crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp).
11315673|NCT03233529|EG000|Reported Event|Crisaborole Ointment 2% + Vehicle in Double-Blind Period|On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the participants who were treated with both crisaborole ointment 2% and vehicle during Days 1 to 14.
11315674|NCT03233529|EG001|Reported Event|Crisaborole Ointment 2% in Open-Label Period|On Days 15 to 42, each participant received crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp).
11315675|NCT03233737|BG000|Baseline|Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB|A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session. Used in Stage II of the study only.
11315676|NCT03233737|BG001|Baseline|Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A|A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session. Used in Stage II of the study only.
11315677|NCT03233737|BG002|Baseline|Stage I: One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315678|NCT03233737|BG003|Baseline|Stage I: One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315679|NCT03233737|BG004|Baseline|Stage I: One Spray CTY-5339-P|Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315680|NCT03233737|BG005|Baseline|Total|Total of all reporting groups
11315681|NCT03233737|FG000|Participant Flow|Stage I: One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315682|NCT03233737|FG001|Participant Flow|Stage I: One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315683|NCT03233737|FG002|Participant Flow|Stage I: One Spray CTY-5339-P|Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315684|NCT03233737|FG003|Participant Flow|Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB|A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session. Used in Stage II of the study only.
11315685|NCT03233737|FG004|Participant Flow|Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A|A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session. Used in Stage II of the study only.
11315686|NCT03233737|OG000|Outcome|One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session.
11315687|NCT03233737|OG001|Outcome|One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session.
11315688|NCT03233737|OG000|Outcome|Stage I: One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315689|NCT03233737|OG001|Outcome|Stage I: One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315690|NCT03233737|OG002|Outcome|Stage I: One Spray CTY-5339-P|Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.
11315691|NCT03233737|OG000|Outcome|Stage I: One Spray CTY-5339-A|"Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.~One spray CTY-5339-A: Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray."
11315692|NCT03233737|OG001|Outcome|Stage I: One Spray CTY-5339-CB|"Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.~One spray CTY-5339-CB: Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray."
11315693|NCT03233737|OG002|Outcome|Stage I: One Spray CTY-5339-P|"Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.~One spray CTY-5339-P: Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control)."
11315694|NCT03233737|EG000|Reported Event|One Spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session.
11315695|NCT03233737|EG001|Reported Event|One Spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session.
11315696|NCT03233737|EG002|Reported Event|One Spray CTY-5339-P|Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session.
11333336|NCT03512041|OG001|Outcome|RLIC - 4 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11333337|NCT03512041|OG002|Outcome|RLIC - 3 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11333338|NCT03512041|OG003|Outcome|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All"
11333339|NCT03512041|EG000|Reported Event|RLIC - 5 Cycles|"Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants underg"
11333340|NCT03512041|EG001|Reported Event|RLIC - 4 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11333899|NCT03521115|FG000|Participant Flow|Smart Choices 4 Teens|"A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component.~Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other."
11333900|NCT03521115|FG001|Participant Flow|Control Condition|This group was provided with websites where information was available regarding the same topics.
11315697|NCT03234036|BG000|Baseline|Part 1: All Participants Receiving GSK2838232/Ritonavir|Eligible participants were assigned to treatment sequence AB or BA where A=single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule under fed condition and B=single dose of GSK2838232 200 mg (as 4 x 50 mg) tablet formulations administered under fed condition in treatment periods 1 and 2 along with ritonavir 100 mg to be taken with water in fed condition. Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg to be taken with water in fasted condition. Treatment periods 1 and 2 were separated by a wash-out period of 10 days. Treatment periods 2 and 3 were separated by a wash-out period of 15 days.
11315698|NCT03234036|BG001|Baseline|Part 2: Placebo|Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
11315699|NCT03234036|BG002|Baseline|Part 2: GSK2838232 500 mg Tablet Fed|Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
11315700|NCT03234036|BG003|Baseline|Total|Total of all reporting groups
11315701|NCT03234036|FG000|Participant Flow|GSK2838232 Capsule Fed/Tablet Fed/Tablet Fasted With Ritonavir|Eligible participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
11315702|NCT03234036|FG001|Participant Flow|GSK2838232 Tablet Fed/Capsule Fed/Tablet Fasted With Ritonavir|Eligible participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
11315703|NCT03234036|FG002|Participant Flow|Part 2: Placebo|Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
11315704|NCT03234036|FG003|Participant Flow|Part 2: GSK2838232 500 mg Tablet Fed|Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
11315705|NCT03234036|OG000|Outcome|Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed|Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
11315706|NCT03234036|OG001|Outcome|Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed|Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
11315707|NCT03234036|OG000|Outcome|Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed|Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation administered under fed conditions in treatment periods 1 and 2 along with ritonavir 100 mg tablet to be taken with water in fed condition.
11315708|NCT03234036|OG001|Outcome|Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted|Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
11315709|NCT03234036|OG000|Outcome|Part 2: Placebo|Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
11315710|NCT03234036|OG001|Outcome|Part 2: GSK2838232 500 mg Tablet Fed|Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
11315711|NCT03234036|OG000|Outcome|Part 2: GSK2838232 500 mg Tablet Fed|Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
11315712|NCT03234036|OG002|Outcome|Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted|Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
11315713|NCT03234036|OG002|Outcome|Part 1: GSK 200 mg/Ritonavir Tablet Fasted|Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
11315714|NCT03234036|EG000|Reported Event|Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed|Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
11315715|NCT03234036|EG001|Reported Event|Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed|Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
11315716|NCT03234036|EG002|Reported Event|Part 1: GSK 200 mg/Ritonavir Tablet Fasted|Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
11315717|NCT03234036|EG003|Reported Event|Part 2: Placebo|Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
11315718|NCT03234036|EG004|Reported Event|Part 2: GSK2838232 500 mg Tablet Fed|Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
11315719|NCT03234374|BG000|Baseline|INL-001|"3 x 100 mg INL-001 (bupivacaine HCl collagen implants). Total bupivacaine HCl dose 300 mg.~INL-001 (bupivacaine HCl collagen implant): 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)"
11315720|NCT03234374|BG001|Baseline|Marcaine 0.25% Infiltration|"Marcaine 0.25% infiltration (bupivacaine HCl 175 mg).~Marcaine 0.25% infiltration: Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration"
11315721|NCT03234374|BG002|Baseline|Total|Total of all reporting groups
11315722|NCT03234374|FG000|Participant Flow|INL-001|"3 x 100 mg INL-001 (bupivacaine HCl collagen implants). Total bupivacaine HCl dose 300 mg.~INL-001 (bupivacaine HCl collagen implant): 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)"
11315723|NCT03234374|FG001|Participant Flow|Marcaine 0.25% Infiltration|"Marcaine 0.25% infiltration (bupivacaine HCl 175 mg).~Marcaine 0.25% infiltration: Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration"
11315724|NCT03234374|OG000|Outcome|INL-001|"3 x 100 mg INL-001 (bupivacaine HCl collagen implants). Total bupivacaine HCl dose 300 mg.~INL-001 (bupivacaine HCl collagen implant): 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)"
11315725|NCT03234374|OG001|Outcome|Marcaine 0.25% Infiltration|"Marcaine 0.25% infiltration (bupivacaine HCl 175 mg).~Marcaine 0.25% infiltration: Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration"
11315726|NCT03234374|EG000|Reported Event|INL-001|"3 x 100 mg INL-001 (bupivacaine HCl collagen implants). Total bupivacaine HCl dose 300 mg.~INL-001 (bupivacaine HCl collagen implant): 3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)"
11315727|NCT03234374|EG001|Reported Event|Marcaine 0.25% Infiltration|"Marcaine 0.25% infiltration (bupivacaine HCl 175 mg).~Marcaine 0.25% infiltration: Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration"
11315728|NCT03234465|BG000|Baseline|AG013|Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315729|NCT03234465|BG001|Baseline|Placebo|Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315730|NCT03234465|BG002|Baseline|Total|Total of all reporting groups
11315731|NCT03234465|FG000|Participant Flow|AG013|Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315732|NCT03234465|FG001|Participant Flow|Placebo|Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315733|NCT03234465|OG000|Outcome|AG013|Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315734|NCT03234465|OG001|Outcome|Placebo|Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315735|NCT03234465|EG000|Reported Event|AG013|Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315736|NCT03234465|EG001|Reported Event|Placebo|Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
11315737|NCT03234608|BG000|Baseline|AASPIRE Healthcare Toolkit|"Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.~AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff."
11315738|NCT03234608|BG001|Baseline|Usual Care|Patients will receive usual care.
11315739|NCT03234608|BG002|Baseline|Total|Total of all reporting groups
11315740|NCT03234608|FG000|Participant Flow|AASPIRE Healthcare Toolkit|"Patients will use the Academic Autism Spectrum Partnership in Research and Education (AASPIRE) Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Tool (AHAT) Report with their primary care provider.~AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's Primary Care Provider (PCP) and other staff."
11315741|NCT03234608|FG001|Participant Flow|Usual Care|Patients will receive usual care.
11315742|NCT03234608|OG000|Outcome|AASPIRE Healthcare Toolkit|"Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.~AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff."
11315743|NCT03234608|OG001|Outcome|Usual Care|Patients will receive usual care.
11335895|NCT03558516|FG000|Participant Flow|Group NSS|The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
10827447|NCT00109837|OG000|Outcome|Treatment|Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
11335896|NCT03558516|FG001|Participant Flow|Group Mg|The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335897|NCT03558516|OG000|Outcome|Group NSS|The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335898|NCT03558516|OG001|Outcome|Group Mg|The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335899|NCT03558516|EG000|Reported Event|Group NSS|The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335900|NCT03558516|EG001|Reported Event|Group Mg|The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
11335901|NCT03558555|BG000|Baseline|Oral Acetaminophen|Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
11335902|NCT03558555|BG001|Baseline|Acetaminophen IV Soln|Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
11335903|NCT03558555|BG002|Baseline|Total|Total of all reporting groups
11335904|NCT03558555|FG000|Participant Flow|Oral Acetaminophen|Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
11335905|NCT03558555|FG001|Participant Flow|Acetaminophen IV Soln|Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
11335906|NCT03558555|OG000|Outcome|Oral Acetaminophen|Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
11335907|NCT03558555|OG001|Outcome|Acetaminophen IV Soln|Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
11335908|NCT03558555|EG000|Reported Event|Oral Acetaminophen|Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
11335909|NCT03558555|EG001|Reported Event|Acetaminophen IV Soln|Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
11335910|NCT03558672|BG000|Baseline|Intervention|Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
11335911|NCT03558672|FG000|Participant Flow|Intervention|Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
11335912|NCT03558672|OG000|Outcome|Intervention|Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
11335913|NCT03558672|EG000|Reported Event|Intervention|Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed.
11335914|NCT03558997|BG000|Baseline|Placebo|Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.
11335915|NCT03558997|BG001|Baseline|Dupilumab|Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335916|NCT03558997|BG002|Baseline|SCIT|Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.
11335917|NCT03558997|BG003|Baseline|Dupilumab + SCIT|Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335918|NCT03558997|BG004|Baseline|Total|Total of all reporting groups
11335919|NCT03558997|FG000|Participant Flow|Placebo|Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.
11335920|NCT03558997|FG001|Participant Flow|Dupilumab|Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335921|NCT03558997|FG002|Participant Flow|SCIT|Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.
11335922|NCT03558997|FG003|Participant Flow|Dupilumab + SCIT|Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335923|NCT03558997|OG000|Outcome|SCIT|Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.
11315744|NCT03234608|EG000|Reported Event|AASPIRE Healthcare Toolkit|"Patients will use the AASPIRE Healthcare Toolkit and will share a copy of their Autism Healthcare Accommodations Report with their primary care provider.~AASPIRE Healthcare Toolkit: The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff."
11315745|NCT03234608|EG001|Reported Event|Usual Care|Patients will receive usual care.
11315746|NCT03235050|BG000|Baseline|Placebo|Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315747|NCT03235050|BG001|Baseline|Liraglutide|Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315748|NCT03235050|BG002|Baseline|MEDI0382 100 mcg|MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315749|NCT03235050|BG003|Baseline|MEDI0382 200 mcg|MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315750|NCT03235050|BG004|Baseline|MEDI0382 300 mcg|MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315751|NCT03235050|BG005|Baseline|Total|Total of all reporting groups
11315752|NCT03235050|FG000|Participant Flow|Placebo|Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315753|NCT03235050|FG001|Participant Flow|Liraglutide|Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315754|NCT03235050|FG002|Participant Flow|MEDI0382 100 mcg|MEDI0382(cotadutide) low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315755|NCT03235050|FG003|Participant Flow|MEDI0382 200 mcg|MEDI0382(cotadutide) mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315756|NCT03235050|FG004|Participant Flow|MEDI0382 300 mcg|MEDI0382(cotadutide) high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315757|NCT03235050|OG000|Outcome|Placebo|Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315758|NCT03235050|OG001|Outcome|MEDI0382 100 mcg|MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
10827448|NCT00109837|OG000|Outcome|Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
10827449|NCT00109837|EG000|Reported Event|First Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
11315759|NCT03235050|OG002|Outcome|MEDI0382 200 mcg|MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315760|NCT03235050|OG003|Outcome|MEDI0382 300 mcg|MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315761|NCT03235050|OG000|Outcome|Liraglutide|Liraglutide / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315762|NCT03235050|EG000|Reported Event|Placebo|Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315763|NCT03235050|EG001|Reported Event|Liraglutide|Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315764|NCT03235050|EG002|Reported Event|MEDI0382 100 mcg|MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315765|NCT03235050|EG003|Reported Event|MEDI0382 200 mcg|MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315766|NCT03235050|EG004|Reported Event|MEDI0382 300 mcg|MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
11315767|NCT03235089|BG000|Baseline|Overall Study|Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours.
11315768|NCT03235089|FG000|Participant Flow|Test Lens|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Test Lens: Daily disposable contact lens"
11315769|NCT03235089|FG001|Participant Flow|Nelfilcon A Lens (Control)|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11315770|NCT03235089|OG000|Outcome|Test Lens|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Test Lens: Daily disposable contact lens"
11315771|NCT03235089|OG001|Outcome|Nelfilcon A Lens (Control)|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11315772|NCT03235089|OG001|Outcome|Nelfilcon A Lens ( Control)|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11315773|NCT03235089|EG000|Reported Event|Test Lens|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Test Lens: Daily disposable contact lens"
11315774|NCT03235089|EG001|Reported Event|Nelfilcon A Lens ( Control)|"Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.~Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11315775|NCT03235115|BG000|Baseline|All Study Participants|All study participants were randomized to wear each of the 3 different contact lens pairs
11315776|NCT03235115|FG000|Participant Flow|Methafilcon A IV, Ocufilcon B, Omafilcon A|Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens
11315777|NCT03235115|FG001|Participant Flow|Methafilcon A IV, Omafilcon A, Ocufilcon B|Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens
11315778|NCT03235115|FG002|Participant Flow|Ocufilcon B, Omafilcon A, Methafilcon A IV|Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens
11315779|NCT03235115|FG003|Participant Flow|Ocufilcon B, Methafilcon A IV, Omafilcon A|Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens
11315780|NCT03235115|FG004|Participant Flow|Omafilcon A, Ocufilcon B, Methafilcon A IV|Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens
11315781|NCT03235115|FG005|Participant Flow|Omafilcon A, Methafilcon A IV, Ocufilcon B|Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens
11315782|NCT03235115|OG000|Outcome|Omafilcon A|Subjects who wore Omafilcon A for 1 hour during the cross over study.
11315783|NCT03235115|OG001|Outcome|Methafilcon A IV|Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
11315784|NCT03235115|OG002|Outcome|Ocufilcon B|Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
11315785|NCT03235115|EG000|Reported Event|Omafilcon A|Subjects who wore Omafilcon A for 1 hour during the cross over study.
11315786|NCT03235115|EG001|Reported Event|Methafilcon A IV|Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.
11315787|NCT03235115|EG002|Reported Event|Ocufilcon B|Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
11315788|NCT03235154|BG000|Baseline|Single Arm Intervention|12-week Epclusa Treatment
11315789|NCT03235154|FG000|Participant Flow|Treatment Arm|"In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program.~sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets."
11315790|NCT03235154|OG000|Outcome|Treatment Arm|"In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program.~sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets."
11315791|NCT03235154|OG000|Outcome|Single Arm Intervention|Subjects who completed baseline and 12-week post treatment questionnaire
11315792|NCT03235154|OG000|Outcome|Single Arm Intervention|12-week Epclusa Treatment
11315793|NCT03235154|EG000|Reported Event|Single Arm Intervention|12-week Epclusa Treatment
11315794|NCT03235180|BG000|Baseline|Crohn's Disease Subjects|"Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent.~Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.~Sulfur Hexafluoride: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.~Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care."
11315795|NCT03235180|FG000|Participant Flow|Crohn's Disease Subjects|"Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent.~Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.~Sulfur Hexafluoride: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.~Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care."
11315796|NCT03235180|OG000|Outcome|Crohn's Disease Subjects|"Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent.~Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.~Sulfur Hexafluoride: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.~Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care."
11333901|NCT03521115|OG000|Outcome|Smart Choices 4 Teens|"A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component.~Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other."
11315797|NCT03235180|EG000|Reported Event|Crohn's Disease Subjects|"Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent.~Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.~Sulfur Hexafluoride: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.~Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.~Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care."
11315798|NCT03235284|BG000|Baseline|Exercises|A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
11315799|NCT03235284|BG001|Baseline|Nintendo Wii|"Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.~The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game"
11315800|NCT03235284|BG002|Baseline|Exercises and Nintendo Wii|Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.
11315801|NCT03235284|BG003|Baseline|Total|Total of all reporting groups
11315802|NCT03235284|FG000|Participant Flow|Exercises|The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb,10 minutes diagonal exercise scapula and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb ,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training;
11315803|NCT03235284|FG001|Participant Flow|Nintendo Wii|"Nintendo Wii program (GNW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.~The GNW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game"
11315804|NCT03235284|FG002|Participant Flow|Exercises and Nintendo Wii|Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.
11315805|NCT03235284|OG000|Outcome|Exercises|A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
11315806|NCT03235284|OG001|Outcome|Nintendo Wii|"Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.~The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game"
11333902|NCT03521115|OG001|Outcome|Assigned Intervention, no Exposures|Assigned to intervention but had no exposure to alcohol component of the intervention.
11333903|NCT03521115|OG002|Outcome|Control Condition|This group received information that was available on an NIAAA website
11333904|NCT03521115|OG001|Outcome|Assigned Experimental, No Exposure|Assigned experimental, No exposure to alcohol component of intervention
11333905|NCT03521115|OG002|Outcome|Control Condition|This group was provided with websites where information was available regarding the same topics.
11315807|NCT03235284|OG002|Outcome|Exercises and Nintendo Wii|Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.
11315808|NCT03235284|EG000|Reported Event|Exercises|A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training. Fatigue, fainting, or changes in blood pressure may occur.
11315809|NCT03235284|EG001|Reported Event|Nintendo Wii|"Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.~The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game. Fatigue, fainting, or changes in blood pressure may occur."
11315810|NCT03235284|EG002|Reported Event|Exercises and Nintendo Wii|A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols. Fatigue, fainting, or changes in blood pressure
11315811|NCT03235349|BG000|Baseline|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
11315812|NCT03235349|FG000|Participant Flow|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
11315813|NCT03235349|OG000|Outcome|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
11315814|NCT03235349|EG000|Reported Event|Glecaprevir/Pibrentasvir|Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
11315815|NCT03235414|BG000|Baseline|Normals|"Healthy participants receive an MRI and a blood draw~MRI: Will receive a one time research MRI (MR elastography)~Blood draw: Will receive a one time blood draw to confirm healthy liver status"
11315816|NCT03235414|FG000|Participant Flow|Normals|"Healthy participants receive an MRI and a blood draw~MRI: Will receive a one time research MRI (MR elastography)~Blood draw: Will receive a one time blood draw to confirm healthy liver status"
11315817|NCT03235414|OG000|Outcome|Healthy Participants|Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
11315818|NCT03235414|EG000|Reported Event|Healthy Participants|Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
11315819|NCT03235479|BG000|Baseline|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315820|NCT03235479|BG001|Baseline|Placebo|Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315821|NCT03235479|BG002|Baseline|Total|Total of all reporting groups
11315822|NCT03235479|FG000|Participant Flow|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315823|NCT03235479|FG001|Participant Flow|Placebo|Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315824|NCT03235479|OG000|Outcome|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315825|NCT03235479|OG001|Outcome|Placebo|Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315826|NCT03235479|EG000|Reported Event|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315827|NCT03235479|EG001|Reported Event|Placebo|Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315828|NCT03235726|BG000|Baseline|Part 1: Cohort A- CCI15106|Healthy participants were administered a SD dose of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315829|NCT03235726|BG001|Baseline|Part 1: Cohort A- Placebo|Healthy participants were administered a SD dose of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315830|NCT03235726|BG002|Baseline|Part 1: Cohort B- CCI15106 60 mg BID|Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315831|NCT03235726|BG003|Baseline|Part 1: Cohort B- Placebo|Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315832|NCT03235726|BG004|Baseline|Part 1: Cohort C- Bystanders|Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
11315833|NCT03235726|BG005|Baseline|Part 2: Cohort A- CCI15106 60 mg SD|Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315834|NCT03235726|BG006|Baseline|Part 2: Cohort A- Placebo|Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
11315835|NCT03235726|BG007|Baseline|Part 2: Cohort B- CCI15106 60 mg BID|Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315836|NCT03235726|BG008|Baseline|Total|Total of all reporting groups
11315837|NCT03235726|FG000|Participant Flow|Part 1: Cohort A- CCI15106 60 mg SD|Healthy participants were administered a single dose (SD) of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315838|NCT03235726|FG001|Participant Flow|Part 1: Cohort A- CCI15106 120 mg SD|Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
11315839|NCT03235726|FG002|Participant Flow|Part 1: Cohort A- CCI15106 30 mg BID|Healthy participants were administered a twice daily (BID) dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315840|NCT03235726|FG003|Participant Flow|Part 1: Cohort A- Placebo|Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
10827450|NCT00109837|EG001|Reported Event|Second Induction|A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone
11315841|NCT03235726|FG004|Participant Flow|Part 1: Cohort B- CCI15106 60 mg BID|Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315842|NCT03235726|FG005|Participant Flow|Part 1: Cohort B- Placebo|Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315843|NCT03235726|FG006|Participant Flow|Part 1: Cohort C- Bystanders|Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
10827451|NCT00109837|EG002|Reported Event|Consolidation|Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate
11315844|NCT03235726|FG007|Participant Flow|Part 2: Cohort A- CCI15106 60 mg SD|Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315845|NCT03235726|FG008|Participant Flow|Part 2: Cohort A- Placebo|Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
11315846|NCT03235726|FG009|Participant Flow|Part 2: Cohort B- CCI15106 60 mg BID|Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315847|NCT03235726|OG000|Outcome|Part 1: Cohort A- CCI15106 60 mg SD|Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315848|NCT03235726|OG001|Outcome|Part 1: Cohort A- CCI15106 120 mg SD|Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
11315849|NCT03235726|OG002|Outcome|Part 1: Cohort A- CCI15106 30 mg BID|Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315850|NCT03235726|OG003|Outcome|Part 1: Cohort A- Placebo|Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
11315851|NCT03235726|OG000|Outcome|Part 1: Cohort B- CCI15106 60 mg BID|Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315852|NCT03235726|OG001|Outcome|Part 1: Cohort B- Placebo|Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315853|NCT03235726|OG000|Outcome|Part 1: Cohort C- Bystanders|Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
11315854|NCT03235726|OG000|Outcome|Part 2: Cohort A- CCI15106 60 mg SD|Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315855|NCT03235726|OG001|Outcome|Part 2: Cohort A- Placebo|Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
11315856|NCT03235726|OG000|Outcome|Part 2: Cohort B- CCI15106 60 mg BID|Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315857|NCT03235726|OG003|Outcome|Part 1: Cohort B- CCI15106 60 mg BID|Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315858|NCT03235726|OG004|Outcome|Part 1: Placebo|Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315859|NCT03235726|OG002|Outcome|Part 2: Cohort B- CCI15106 60 mg BID|Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315860|NCT03235726|OG000|Outcome|Part 1: Cohort A- CCI15106 120 mg SD|Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
11315861|NCT03235726|OG000|Outcome|Part 1: Cohort A- CCI15106 30 mg BID|Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315862|NCT03235726|OG000|Outcome|Part 1: Placebo|Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315863|NCT03235726|OG000|Outcome|Part 1: Bystander Group 1- Session 1|Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
11315864|NCT03235726|OG001|Outcome|Part 1: Bystander Group 1- Session 2|Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
10827452|NCT00109837|EG003|Reported Event|Maintenance|Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
11315865|NCT03235726|OG002|Outcome|Part 1: Bystander Group 2- Session 1|Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
11315866|NCT03235726|OG003|Outcome|Part 1: Bystander Group 2- Session 2|Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
11315867|NCT03235726|OG004|Outcome|Part 1: Bystander Group 3- Session 1|Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in a single session on Days 1, 7 and 14.
11315868|NCT03235726|OG005|Outcome|Part 1: Bystander Group 4- Session 1|Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
11315869|NCT03235726|OG006|Outcome|Part 1: Bystander Group 4- Session 2|Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
11315870|NCT03235726|EG000|Reported Event|Part 1: Cohort A- CCI15106 60 mg SD|Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315871|NCT03235726|EG001|Reported Event|Part 1: Cohort A- CCI15106 120 mg SD|Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
11315872|NCT03235726|EG002|Reported Event|Part 1: Cohort A- CCI15106 30 mg BID|Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
11315873|NCT03235726|EG003|Reported Event|Part 1: Cohort A- Placebo|Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
11315874|NCT03235726|EG004|Reported Event|Part 1: Cohort B- CCI15106 60 mg BID|Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315875|NCT03235726|EG005|Reported Event|Part 1: Cohort B- Placebo|Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
11315876|NCT03235726|EG006|Reported Event|Part 1: Cohort C- Bystanders|Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
11315877|NCT03235726|EG007|Reported Event|Part 2: Cohort A- CCI15106 60 mg SD|Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
11315878|NCT03235726|EG008|Reported Event|Part 2: Cohort A- Placebo|Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
11315879|NCT03235726|EG009|Reported Event|Part 2: Cohort B- CCI15106 60 mg BID|Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
11315880|NCT03236168|BG000|Baseline|Intervention Arm|"This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo~Ivermectin: A single weight based dose of ivermectin~Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated~Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated"
11315881|NCT03236168|FG000|Participant Flow|Intervention Arm|"This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo~Ivermectin: A single weight based dose of ivermectin~Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated~Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated"
11315882|NCT03236168|OG000|Outcome|Intervention Arm|"This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo~Ivermectin: A single weight based dose of ivermectin~Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated~Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated"
11315883|NCT03236168|EG000|Reported Event|Intervention Arm|"This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo~Ivermectin: A single weight based dose of ivermectin~Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated~Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated"
11315884|NCT03236246|BG000|Baseline|KRX-0502 3 g/Day|Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315885|NCT03236246|BG001|Baseline|KRX-0502 4 g/Day|Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315886|NCT03236246|BG002|Baseline|Total|Total of all reporting groups
11315887|NCT03236246|FG000|Participant Flow|KRX-0502 3 g/Day|Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315888|NCT03236246|FG001|Participant Flow|KRX-0502 4 g/Day|Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315889|NCT03236246|OG000|Outcome|KRX-0502 3 g/Day|Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315890|NCT03236246|OG001|Outcome|KRX-0502 4 g/Day|Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315891|NCT03236246|EG000|Reported Event|KRX-0502 3 g/Day|Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11333906|NCT03521115|OG001|Outcome|Assigned Experimental, no Exposure|This group had no exposure to the intervention relating to sexual communication and behaviors
10827453|NCT00109850|BG000|Baseline|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
10827454|NCT00109850|FG000|Participant Flow|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
11315892|NCT03236246|EG001|Reported Event|KRX-0502 4 g/Day|Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.
11315893|NCT03236506|BG000|Baseline|Daily Observed Therapy|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315894|NCT03236506|BG001|Baseline|Fortnightly Pick-up|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315895|NCT03236506|BG002|Baseline|Fortnightly Pick-up +Psych Intervention|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, Hepatitis C and Me. The booklet uses the principles of node-link mapping to structure the intervention.~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315896|NCT03236506|BG003|Baseline|Total|Total of all reporting groups
11315897|NCT03236506|FG000|Participant Flow|Daily Observed Therapy|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315898|NCT03236506|FG001|Participant Flow|Fortnightly Pick-up|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315899|NCT03236506|FG002|Participant Flow|Fortnightly Pick-up +Psych Intervention|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, Hepatitis C and Me. The booklet uses the principles of node-link mapping to structure the intervention.~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315900|NCT03236506|OG000|Outcome|Daily Observed Therapy|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315901|NCT03236506|OG001|Outcome|Fortnightly Pick-up|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11333907|NCT03521115|OG001|Outcome|Assigned Intervention, no Exposure|This group was assigned to the intervention but had no exposure to the relationship component of the intervention.
10848560|NCT00290472|BG000|Baseline|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
11315902|NCT03236506|OG002|Outcome|Fortnightly Pick-up +Psych Intervention|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, Hepatitis C and Me. The booklet uses the principles of node-link mapping to structure the intervention.~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315903|NCT03236506|EG000|Reported Event|Daily Observed Therapy|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315904|NCT03236506|EG001|Reported Event|Fortnightly Pick-up|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315905|NCT03236506|EG002|Reported Event|Fortnightly Pick-up +Psych Intervention|"Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen.~Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection~Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, Hepatitis C and Me. The booklet uses the principles of node-link mapping to structure the intervention.~Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection"
11315906|NCT03236779|BG000|Baseline|Dry Needling (DN) Arm|"Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11315907|NCT03236779|BG001|Baseline|Percutaneous Needle Electrolysis (PNE) Arm|"The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11315908|NCT03236779|BG002|Baseline|Total|Total of all reporting groups
11315909|NCT03236779|FG000|Participant Flow|Dry Needling (DN) Arm|"Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11315910|NCT03236779|FG001|Participant Flow|Percutaneous Needle Electrolysis (PNE) Arm|"The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11333908|NCT03521115|OG002|Outcome|Control Condition|This group was provided with websites where information was available regarding ...
11315911|NCT03236779|OG000|Outcome|Dry Needling (DN) Arm|"Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11315912|NCT03236779|OG001|Outcome|Percutaneous Needle Electrolysis (PNE) Arm|"The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.~dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied."
11315913|NCT03236779|OG000|Outcome|VAS DN|the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
11315914|NCT03236779|OG001|Outcome|VAS PNE|the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
11315915|NCT03236779|EG000|Reported Event|Dry Needling|Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).
11315916|NCT03236779|EG001|Reported Event|Percutaneous Needle Electrolysis|The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).
11315917|NCT03237013|BG000|Baseline|Control (Treatment as Usual Only)|"Following baseline assessment, all participants were given health literature on tanning behavior from the U.S. Centers for Disease Control and Prevention (CDC). These materials included informational pamphlets addressing common myths regarding tanning behaviors, including Tanned skin is not healthy skin, and A base tan is not a safe tan. These misconceptions were accompanied by burning truth, scientific data debunking these myths. Additionally, all participants received a packet on sun protective practices for oneself and family, which include skin cancer statistics and information on UV rays."
11315918|NCT03237013|BG001|Baseline|Treatment as Usual + Facial Morphing|"In addition to the health literature, participants completed the Facial Morphing Intervention. Participants had a digital photograph taken and uploaded to the APRIL® software, accompanied by information about their current age and self-identified race. Participants were presented with two, side-by-side identical 2D images of their face. Participants first viewed an image of their face from their current age, in two-year intervals, to age 72, the maximum age, with the UV exposure setting turned on. This process was repeated. Next, participants viewed the projected aging process, toggling the UV exposure setting (on and off), every ten year interval. The process was repeated using 3D images to view projected changes to their facial profiles.~Facial Morphing Intervention: Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure."
11315919|NCT03237013|BG002|Baseline|Treatment as Usual + Mindfulness|"In addition to the health literature, participants completed the Mindfulness Intervention. Participants listened to a 10-minute self-guided mindfulness audio exercise. The audio file is a scripted reading of an established brief mindfulness exercise (Erisman & Roemer, 2010). During this guided session, participants learned what mindfulness was, when it can be used, and benefits from practice. Listeners were led through steps, focusing on the physical sensations, breathing, and thoughts. After the exercise, participants were provided a handout highlighting key points about mindfulness and how to incorporate informal mindfulness practice into their daily life.~Mindfulness Intervention: Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance. For example, participants were instructed to notice their breath, thoughts, feelings, ph"
11315920|NCT03237013|BG003|Baseline|Total|Total of all reporting groups
11315921|NCT03237013|FG000|Participant Flow|Control (Treatment as Usual Only)|"Following baseline assessment, all participants were given health literature on tanning behavior from the U.S. Centers for Disease Control and Prevention (CDC). These materials included informational pamphlets addressing common myths regarding tanning behaviors, including Tanned skin is not healthy skin, and A base tan is not a safe tan. These misconceptions were accompanied by burning truth, scientific data debunking these myths. Additionally, all participants received a packet on sun protective practices for oneself and family, which include skin cancer statistics and information on UV rays."
10827455|NCT00109850|OG000|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
11315922|NCT03237013|FG001|Participant Flow|Treatment as Usual + Facial Morphing|"In addition to the health literature, participants completed the Facial Morphing Intervention. Participants had a digital photograph taken and uploaded to the APRIL® software, accompanied by information about their current age and self-identified race. Participants were presented with two, side-by-side identical 2D images of their face. Participants first viewed an image of their face from their current age, in two-year intervals, to age 72, the maximum age, with the UV exposure setting turned on. This process was repeated. Next, participants viewed the projected aging process, toggling the UV exposure setting (on and off), every ten year interval. The process was repeated using 3D images to view projected changes to their facial profiles.~Facial Morphing Intervention: Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure."
11315923|NCT03237013|FG002|Participant Flow|Treatment as Usual + Mindfulness|"In addition to the health literature, participants completed the Mindfulness Intervention. Participants listened to a 10-minute self-guided mindfulness audio exercise. The audio file is a scripted reading of an established brief mindfulness exercise (Erisman & Roemer, 2010). During this guided session, participants learned what mindfulness was, when it can be used, and benefits from practice. Listeners were led through steps, focusing on the physical sensations, breathing, and thoughts. After the exercise, participants were provided a handout highlighting key points about mindfulness and how to incorporate informal mindfulness practice into their daily life.~Mindfulness Intervention: Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance. For example, participants were instructed to notice their breath, thoughts, feelings, ph"
11315924|NCT03237013|OG000|Outcome|Control (Treatment as Usual Only)|"Following baseline assessment, all participants were given health literature on tanning behavior from the U.S. Centers for Disease Control and Prevention (CDC). These materials included informational pamphlets addressing common myths regarding tanning behaviors, including Tanned skin is not healthy skin, and A base tan is not a safe tan. These misconceptions were accompanied by burning truth, scientific data debunking these myths. Additionally, all participants received a packet on sun protective practices for oneself and family, which include skin cancer statistics and information on UV rays."
11315925|NCT03237013|OG001|Outcome|Treatment as Usual + Facial Morphing|"In addition to the health literature, participants completed the Facial Morphing Intervention. Participants had a digital photograph taken and uploaded to the APRIL® software, accompanied by information about their current age and self-identified race. Participants were presented with two, side-by-side identical 2D images of their face. Participants first viewed an image of their face from their current age, in two-year intervals, to age 72, the maximum age, with the UV exposure setting turned on. This process was repeated. Next, participants viewed the projected aging process, toggling the UV exposure setting (on and off), every ten year interval. The process was repeated using 3D images to view projected changes to their facial profiles.~Facial Morphing Intervention: Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure."
11315926|NCT03237013|OG002|Outcome|Treatment as Usual + Mindfulness|"In addition to the health literature, participants completed the Mindfulness Intervention. Participants listened to a 10-minute self-guided mindfulness audio exercise. The audio file is a scripted reading of an established, brief mindfulness exercise (Erisman & Roemer, 2010). During this guided session, participants learned what mindfulness was, when it can be used, and benefits from practice. Listeners were led through steps, focusing on the physical sensations, breathing, and thoughts. After the exercise, participants were provided a handout highlighting key points about mindfulness and how to incorporate informal mindfulness practice into their daily life.~Mindfulness Intervention: Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance."
11315927|NCT03237013|EG000|Reported Event|Control (Treatment as Usual Only)|"Following baseline assessment, all participants were given health literature on tanning behavior from the U.S. Centers for Disease Control and Prevention (CDC). These materials included informational pamphlets addressing common myths regarding tanning behaviors, including Tanned skin is not healthy skin, and A base tan is not a safe tan. These misconceptions were accompanied by burning truth, scientific data debunking these myths. Additionally, all participants received a packet on sun protective practices for oneself and family, which include skin cancer statistics and information on UV rays."
11315928|NCT03237013|EG001|Reported Event|Treatment as Usual + Facial Morphing|"In addition to the health literature, participants completed the Facial Morphing Intervention. Participants had a digital photograph taken and uploaded to the APRIL® software, accompanied by information about their current age and self-identified race. Participants were presented with two, side-by-side identical 2D images of their face. Participants first viewed an image of their face from their current age, in two-year intervals, to age 72, the maximum age, with the UV exposure setting turned on. This process was repeated. Next, participants viewed the projected aging process, toggling the UV exposure setting (on and off), every ten year interval. The process was repeated using 3D images to view projected changes to their facial profiles.~Facial Morphing Intervention: Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure."
11335924|NCT03558997|OG001|Outcome|Dupilumab + SCIT|Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335925|NCT03558997|OG000|Outcome|Placebo|Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.
10827456|NCT00109850|EG000|Reported Event|Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
11315929|NCT03237013|EG002|Reported Event|Treatment as Usual + Mindfulness|"In addition to the health literature, participants completed the Mindfulness Intervention. Participants listened to a 10-minute self-guided mindfulness audio exercise. The audio file is a scripted reading of an established brief mindfulness exercise (Erisman & Roemer, 2010). During this guided session, participants learned what mindfulness was, when it can be used, and benefits from practice. Listeners were led through steps, focusing on the physical sensations, breathing, and thoughts. After the exercise, participants were provided a handout highlighting key points about mindfulness and how to incorporate informal mindfulness practice into their daily life.~Mindfulness Intervention: Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance. For example, participants were instructed to notice their breath, thoughts, feelings, ph"
11315930|NCT03237065|BG000|Baseline|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11315931|NCT03237065|BG001|Baseline|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11315932|NCT03237065|BG002|Baseline|Total|Total of all reporting groups
11315933|NCT03237065|FG000|Participant Flow|Iron Isomaltoside/Ferric Derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg iron isomaltoside/ferric derisomaltose at the baseline visit."
11315934|NCT03237065|FG001|Participant Flow|Ferric Carboxymaltose|"Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.~The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg)."
11315935|NCT03237065|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11315936|NCT03237065|OG001|Outcome|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11315937|NCT03237065|EG000|Reported Event|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11315938|NCT03237065|EG001|Reported Event|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11315939|NCT03237156|BG000|Baseline|Cohorts 1-3: Placebo|TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315940|NCT03237156|BG001|Baseline|Cohort 1: TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315941|NCT03237156|BG002|Baseline|Cohort 2: TAK-906 100 mg|TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315942|NCT03237156|BG003|Baseline|Cohort 3: TAK-906 10 mg|TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315943|NCT03237156|BG004|Baseline|Total|Total of all reporting groups
11315944|NCT03237156|FG000|Participant Flow|Cohorts 1-3: Placebo|TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315945|NCT03237156|FG001|Participant Flow|Cohort 1: TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315946|NCT03237156|FG002|Participant Flow|Cohort 2: TAK-906 100 mg|TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315947|NCT03237156|FG003|Participant Flow|Cohort 3: TAK-906 10 mg|TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315948|NCT03237156|OG000|Outcome|Cohorts 1-3: Placebo|TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315949|NCT03237156|OG001|Outcome|Cohort 1: TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315950|NCT03237156|OG002|Outcome|Cohort 2: TAK-906 100 mg|TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315951|NCT03237156|OG003|Outcome|Cohort 3: TAK-906 10 mg|TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315952|NCT03237156|OG000|Outcome|Cohort 1: TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315953|NCT03237156|OG001|Outcome|Cohort 2: TAK-906 100 mg|TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315954|NCT03237156|OG002|Outcome|Cohort 3: TAK-906 10 mg|TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315955|NCT03237156|EG000|Reported Event|Cohorts 1-3: Placebo|TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315956|NCT03237156|EG001|Reported Event|Cohort 1: TAK-906 50 mg|TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315957|NCT03237156|EG002|Reported Event|Cohort 2: TAK-906 100 mg|TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
10827457|NCT00109876|BG000|Baseline|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
11315958|NCT03237156|EG003|Reported Event|Cohort 3: TAK-906 10 mg|TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period.
11315959|NCT03237481|BG000|Baseline|Treatment Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
11315960|NCT03237481|BG001|Baseline|Treatment Group 2: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 75 mg by injection.
11315961|NCT03237481|BG002|Baseline|Treatment Group 3: Saline Placebo|Saline Placebo by instillation.
11315962|NCT03237481|BG003|Baseline|Total|Total of all reporting groups
11315963|NCT03237481|FG000|Participant Flow|Treatment Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
11315964|NCT03237481|FG001|Participant Flow|Treatment Group 2: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 75 mg by injection.
11315965|NCT03237481|FG002|Participant Flow|Treatment Group 3: Saline Placebo|Saline Placebo by instillation.
11315966|NCT03237481|OG000|Outcome|Treatment Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
11315967|NCT03237481|OG001|Outcome|Treatment Group 3: Saline Placebo|Saline Placebo by instillation.
11315968|NCT03237481|OG001|Outcome|Treatment Group 2: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 75 mg by injection.
11315969|NCT03237481|EG000|Reported Event|Treatment Group 1: HTX-011|HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
11315970|NCT03237481|EG001|Reported Event|Treatment Group 2: Bupivacaine HCI|"Bupivacaine HCl without epinephrine, 75 mg by injection.~173 = Safety Population because 1 subject was randomized to HTX-011, but received bupivacaine HCl."
11315971|NCT03237481|EG002|Reported Event|Treatment Group 3: Saline Placebo|Saline Placebo by instillation.
11315972|NCT03237845|BG000|Baseline|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315973|NCT03237845|BG001|Baseline|Placebo|Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315974|NCT03237845|BG002|Baseline|Total|Total of all reporting groups
11315975|NCT03237845|FG000|Participant Flow|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315976|NCT03237845|FG001|Participant Flow|Placebo|Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315977|NCT03237845|OG000|Outcome|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315978|NCT03237845|OG001|Outcome|Placebo|Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315979|NCT03237845|EG000|Reported Event|Rimegepant 75 mg|Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315980|NCT03237845|EG001|Reported Event|Placebo|Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11315981|NCT03237871|BG000|Baseline|Survey and Informational Text Messages|"Text-message survey and informational text messages~Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment."
11315982|NCT03237871|FG000|Participant Flow|Survey and Informational Text Messages|"Text-message survey and informational text messages~Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment."
11315983|NCT03237871|OG000|Outcome|Survey and Informational Text Messages|"Text-message survey and informational text messages~Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment."
11315984|NCT03237871|EG000|Reported Event|Survey and Informational Text Messages|"Text-message survey and informational text messages~Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment."
11315985|NCT03238001|BG000|Baseline|All Participants|All participants enrolled in the study.
11315986|NCT03238001|FG000|Participant Flow|All Qualified Participants|Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments.
11315987|NCT03238001|OG000|Outcome|Primary Endpoint (Evaluable) Population|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
11315988|NCT03238001|OG000|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit.
11315989|NCT03238001|OG001|Outcome|MMSE|Participants received MMSE and MoCA on their first visit.
11315990|NCT03238001|OG000|Outcome|DCTclock|Participants received DCTclock and MoCA on their first visit
11315991|NCT03238001|OG000|Outcome|DCTclock|Participants received DCTclock on their first and second visits, occurring 1-4 weeks apart.
11315992|NCT03238001|OG001|Outcome|MMSE|Participants received MMSE on their first and second visits, occurring 1-4 weeks apart.
11315993|NCT03238001|OG000|Outcome|DCTclock|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
11315994|NCT03238001|OG001|Outcome|MMSE|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
11315995|NCT03238001|OG000|Outcome|All Participants|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
11315996|NCT03238001|EG000|Reported Event|All Participants|Participants received DCTclock, MMSE, MoCA, and a battery of other traditional, pen and paper neuropsychological assessments.
11315997|NCT03238352|BG000|Baseline|Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11315998|NCT03238352|BG001|Baseline|Negative Control (0.02% w/w Sodium Fluoride)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11315999|NCT03238352|BG002|Baseline|Placebo (0% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316000|NCT03238352|BG003|Baseline|Total|Total of all reporting groups
11316001|NCT03238352|FG000|Participant Flow|Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 milliliters (mL) of oral rinse (1.5% KOX, 0 parts per million [ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316002|NCT03238352|FG001|Participant Flow|Negative Control (0.02% w/w Sodium Fluoride)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% weight by weight [w/w] sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316003|NCT03238352|FG002|Participant Flow|Placebo (0% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316004|NCT03238352|OG000|Outcome|Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316005|NCT03238352|OG001|Outcome|Negative Control (0.02% w/w Sodium Fluoride)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316006|NCT03238352|OG002|Outcome|Placebo (0% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316007|NCT03238352|EG000|Reported Event|Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316008|NCT03238352|EG001|Reported Event|Negative Control (0.02% w/w Sodium Fluoride)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316009|NCT03238352|EG002|Reported Event|Placebo (0% KOX, 0 Ppm Fluoride, pH 7)|Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
11316010|NCT03238417|BG000|Baseline|Evidence-Based Quality Improvement (EBQI)|"EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.~Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines."
11316011|NCT03238417|BG001|Baseline|Waitlist Controls|Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.
11316012|NCT03238417|BG002|Baseline|Total|Total of all reporting groups
11335926|NCT03558997|OG001|Outcome|Dupilumab|Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11335927|NCT03558997|OG000|Outcome|Dupilumab|Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11316013|NCT03238417|FG000|Participant Flow|Evidence-Based Quality Improvement (EBQI)|"EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level quality improvement (QI) team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.~Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines."
11316014|NCT03238417|FG001|Participant Flow|Waitlist Controls|Waitlist controls will continue naturalistic routine care implementation of VA directives and other guidance related to comprehensive women's health care.
11316015|NCT03238417|OG000|Outcome|Evidence-Based Quality Improvement (EBQI)|"EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.~Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines."
11316016|NCT03238417|OG001|Outcome|Waitlist Controls|Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.
11316017|NCT03238417|EG000|Reported Event|Evidence-Based Quality Improvement (EBQI)|"EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.~Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines."
11316018|NCT03238417|EG001|Reported Event|Waitlist Controls|Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.
11316019|NCT03238651|BG000|Baseline|Dose Escalation Part, Dosing Schedule A: TAK-659 40 mg|TAK-659 40 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316020|NCT03238651|BG001|Baseline|Dose Escalation Part, Dosing Schedule A: TAK-659 60 mg|TAK-659 60 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316021|NCT03238651|BG002|Baseline|Dose Escalation Part, Dosing Schedule A: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316022|NCT03238651|BG003|Baseline|Dose Escalation Part, Dosing Schedule B: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316023|NCT03238651|BG004|Baseline|Dose Escalation Part, Dosing Schedule B: TAK-659 100 mg|TAK-659 100 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316024|NCT03238651|BG005|Baseline|Total|Total of all reporting groups
11316025|NCT03238651|FG000|Participant Flow|Dose Escalation Part, Dosing Schedule A: TAK-659 40 mg|TAK-659 40 milligram (mg), tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316026|NCT03238651|FG001|Participant Flow|Dose Escalation Part, Dosing Schedule A: TAK-659 60 mg|TAK-659 60 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316027|NCT03238651|FG002|Participant Flow|Dose Escalation Part, Dosing Schedule A: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316028|NCT03238651|FG003|Participant Flow|Dose Escalation Part, Dosing Schedule B: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316029|NCT03238651|FG004|Participant Flow|Dose Escalation Part, Dosing Schedule B: TAK-659 100 mg|TAK-659 100 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316030|NCT03238651|OG000|Outcome|Dose Escalation Part, Schedule Dosing A: TAK-659 40 mg|TAK-659 40 mg, tablet, orally, once daily, in a 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316031|NCT03238651|OG001|Outcome|Dose Escalation Part, Dosing Schedule A: TAK-659 60 mg|TAK-659 60 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316032|NCT03238651|OG002|Outcome|Dose Escalation Part, Dosing Schedule A: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316033|NCT03238651|OG003|Outcome|Dose Escalation Part, Dosing Schedule B: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316034|NCT03238651|OG004|Outcome|Dose Escalation Part, Dosing Schedule B: TAK-659 100 mg|TAK-659 100 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316035|NCT03238651|OG000|Outcome|Dose Escalation Part, Schedule Dosing A: TAK-659 40 mg|TAK-659 40 mg, tablet, orally, once daily, in a 28-days treatment cycle disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316036|NCT03238651|EG000|Reported Event|Dose Escalation Part, Dosing Schedule A: TAK-659 40 mg|TAK-659 40 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316037|NCT03238651|EG001|Reported Event|Dose Escalation Part, Dosing Schedule A: TAK-659 60 mg|TAK-659 60 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316038|NCT03238651|EG002|Reported Event|Dose Escalation Part, Dosing Schedule A: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316039|NCT03238651|EG003|Reported Event|Dose Escalation Part, Dosing Schedule B: TAK-659 80 mg|TAK-659 80 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316040|NCT03238651|EG004|Reported Event|Dose Escalation Part, Dosing Schedule B: TAK-659 100 mg|TAK-659 100 mg, tablet, orally, once daily as 7 days on and 7 days off treatment (dosing on 7 days followed by 7 days of rest) in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal due to other reasons.
11316041|NCT03238781|BG000|Baseline|Placebo|Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period.
11316042|NCT03238781|BG001|Baseline|AMG 301 210 mg Q4W|Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period.
11316043|NCT03238781|BG002|Baseline|AMG 301 420 mg Q2W|Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
11316044|NCT03238781|BG003|Baseline|Total|Total of all reporting groups
11316045|NCT03238781|FG000|Participant Flow|Placebo|Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period.
11316046|NCT03238781|FG001|Participant Flow|AMG 301 210 mg Q4W|Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period.
11316047|NCT03238781|FG002|Participant Flow|AMG 301 420 mg Q2W|Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
11316048|NCT03238781|OG000|Outcome|Placebo|Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period.
11316049|NCT03238781|OG001|Outcome|AMG 301 210 mg Q4W|Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period.
11316050|NCT03238781|OG002|Outcome|AMG 301 420 mg Q2W|Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
11316051|NCT03238781|EG000|Reported Event|Placebo|Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period.
11316052|NCT03238781|EG001|Reported Event|AMG 301 210 mg Q4W|Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period.
11316053|NCT03238781|EG002|Reported Event|AMG 301 420 mg Q2W|Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
11316054|NCT03238911|BG000|Baseline|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11316055|NCT03238911|BG001|Baseline|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11316056|NCT03238911|BG002|Baseline|Total|Total of all reporting groups
11316057|NCT03238911|FG000|Participant Flow|Iron Isomaltoside/Ferric Derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit."
11316058|NCT03238911|FG001|Participant Flow|Ferric Carboxymaltose|"Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.~The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg)."
11316059|NCT03238911|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11316060|NCT03238911|OG001|Outcome|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11316061|NCT03238911|OG000|Outcome|Iron Isomaltoside/Ferric Derisomaltose|Iron Isomaltoside/ferric derisomaltose, administered IV
11316062|NCT03238911|EG000|Reported Event|Iron Isomaltoside/Ferric Derisomaltose|Iron isomaltoside/ferric derisomaltose, administered IV
11316063|NCT03238911|EG001|Reported Event|Ferric Carboxymaltose|Ferric carboxymaltose, administered IV
11316064|NCT03238924|BG000|Baseline|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
11316065|NCT03238924|BG001|Baseline|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
11316066|NCT03238924|BG002|Baseline|Total|Total of all reporting groups
10827458|NCT00109876|FG000|Participant Flow|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
11316067|NCT03238924|FG000|Participant Flow|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
11316068|NCT03238924|FG001|Participant Flow|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
11316069|NCT03238924|OG000|Outcome|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
11316070|NCT03238924|OG001|Outcome|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
11316071|NCT03238924|EG000|Reported Event|Oxytocin|"40 IU intranasal oxytocin spray~Oxytocin: 40 IU oxytocin nasal spray, self-administered"
11316072|NCT03238924|EG001|Reported Event|Placebo|"Placebo is matching saline nasal spray~Placebos: Saline nasal spray, self-administered"
11316073|NCT03238963|BG000|Baseline|BI 1467335 10 mg|2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316074|NCT03238963|BG001|Baseline|Placebo|2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316075|NCT03238963|BG002|Baseline|Total|Total of all reporting groups
11316076|NCT03238963|FG000|Participant Flow|BI 1467335 10 mg|2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316077|NCT03238963|FG001|Participant Flow|Placebo|2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316078|NCT03238963|OG000|Outcome|BI 1467335 10 mg|2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316079|NCT03238963|OG001|Outcome|Placebo|2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316080|NCT03238963|EG000|Reported Event|BI 1467335 10 mg|2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316081|NCT03238963|EG001|Reported Event|Placebo|2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
11316082|NCT03239106|BG000|Baseline|Open Label|All participants will receive apremilast 30 mg PO BID.
11316083|NCT03239106|FG000|Participant Flow|Open Label|All participants will received apremilast 30 mg PO BID.
11316084|NCT03239106|OG000|Outcome|Open Label|"All participants will receive apremilast 30 mg PO BID.~The data were analyzed in an intent-to-treat manner with key primary and secondary endpoints measured as an absolute reduction in NRS itch and DLQI scores, respectively at week 16 from baseline. Thirty percent of the patients completed the study, which did not allow for meaningful intent-to-treat statistical analysis. As an alternative approach, we undertook a LOCF analysis by carrying forward to week 16."
11316085|NCT03239106|OG000|Outcome|Open Label|"All participants will receive Apremilast 30 mg BID.~Apremilast: Apremilast 30 mg BID daily"
11316086|NCT03239106|EG000|Reported Event|Open Label|All participants will receive apremilast 30 mg PO BID.
11316087|NCT03239470|BG000|Baseline|Cohort 1: Polyclonal Treg Infusion (PolyTregs) Low Dose|Participants donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs). After two weeks, participants received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 1 x 10^8 PolyTregs.
11316088|NCT03239470|FG000|Participant Flow|Cohort 1: Polyclonal Treg Infusion (PolyTregs) Low Dose|Participants donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs). After two weeks, participants received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 1 x 10^8 PolyTregs.
11316089|NCT03239470|FG001|Participant Flow|Cohort 2: Polyclonal Treg Infusion (Poly Tregs) High Dose|Participants donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs). After two weeks, participants received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 2.5 x 10^8 PolyTregs. Study enrollment was closed prior to enrolling participants into Cohort 2.
11316090|NCT03239470|OG000|Outcome|Cohort 1: Polyclonal Treg Infusion (PolyTregs)|Participants donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs). After two weeks, participants received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 1 x 10^8 PolyTregs.
11316091|NCT03239470|EG000|Reported Event|Cohort 1: Polyclonal Treg Infusion (PolyTregs) Low Dose|Participants donated peripheral blood to be processed in a lab that expanded regulatory T cells (Tregs). After two weeks, participants received a single infusion of ex vivo expanded autologous CD4+CD127lo/-CD25+ polyclonal Tregs (PolyTregs). Target cell dose was 1 x 10^8 PolyTregs.
11316092|NCT03239483|BG000|Baseline|Dapivirine Gel|"Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.~Dapivirine gel: Dapivirine gel (0.05%); administered rectally"
11316093|NCT03239483|BG001|Baseline|Placebo Gel|"Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.~Placebo gel: Universal HEC placebo gel; administered rectally"
11316094|NCT03239483|BG002|Baseline|Total|Total of all reporting groups
11316095|NCT03239483|FG000|Participant Flow|Dapivirine Gel|"Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.~Dapivirine gel: Dapivirine gel (0.05%); administered rectally"
11316096|NCT03239483|FG001|Participant Flow|Placebo Gel|"Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.~Placebo gel: Universal HEC placebo gel; administered rectally"
11316097|NCT03239483|OG000|Outcome|Dapivirine Gel|"Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.~Dapivirine gel: Dapivirine gel (0.05%); administered rectally"
11316098|NCT03239483|OG001|Outcome|Placebo Gel|"Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.~Placebo gel: Universal HEC placebo gel; administered rectally"
11316099|NCT03239483|EG000|Reported Event|Dapivirine Gel|"Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.~Dapivirine gel: Dapivirine gel (0.05%); administered rectally"
11316100|NCT03239483|EG001|Reported Event|Placebo Gel|"Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.~Placebo gel: Universal HEC placebo gel; administered rectally"
11316101|NCT03239496|BG000|Baseline|Group A|"3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316102|NCT03239496|BG001|Baseline|Group B|"2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316103|NCT03239496|BG002|Baseline|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316104|NCT03239496|BG003|Baseline|Group D|"2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316105|NCT03239496|BG004|Baseline|Total|Total of all reporting groups
11316106|NCT03239496|FG000|Participant Flow|Group A|"3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316107|NCT03239496|FG001|Participant Flow|Group B|"2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316108|NCT03239496|FG002|Participant Flow|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316109|NCT03239496|FG003|Participant Flow|Group D|"2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316110|NCT03239496|OG000|Outcome|Group B|"2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316111|NCT03239496|OG001|Outcome|Group D|"2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316112|NCT03239496|OG000|Outcome|Group A|"3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316113|NCT03239496|OG001|Outcome|Group B|"2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316114|NCT03239496|OG000|Outcome|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316115|NCT03239496|OG001|Outcome|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316116|NCT03239496|OG002|Outcome|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316117|NCT03239496|OG003|Outcome|Group D|"2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316118|NCT03239496|EG000|Reported Event|Group A|"3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316119|NCT03239496|EG001|Reported Event|Group B|"2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316120|NCT03239496|EG002|Reported Event|Group C|"3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316121|NCT03239496|EG003|Reported Event|Group D|"2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.~f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)"
11316122|NCT03239522|BG000|Baseline|All Participants Receiving GSK1278863|Participants received a single 6 milligram (mg) oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 microgram (µg) [14C]-GSK1278863 by IV infusion over 1 hour. It was followed by a washout period of 7 days. On Day 1 of treatment period 2, each participant received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours.
11316123|NCT03239522|FG000|Participant Flow|All Participants Receiving GSK1278863|Participants received a single 6 milligram (mg) oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 microgram (µg) [14C]-GSK1278863 by IV infusion over 1 hour. It was followed by a washout period of 7 days. On Day 1 of treatment period 2, each participant received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours.
11316124|NCT03239522|OG000|Outcome|[14C]-GSK1278863 50 µg IV Infusion|Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.
11316125|NCT03239522|OG001|Outcome|[14C]-GSK1278863 25 mg Oral Solution|Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.
11316126|NCT03239522|OG000|Outcome|[14C]-GSK1278863 25 mg Oral Solution|Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.
11316127|NCT03239522|OG000|Outcome|GSK1278863 6 mg Oral Tablet|Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.
11316128|NCT03239522|OG001|Outcome|[14C]-GSK1278863 50 µg IV Infusion|Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.
11316129|NCT03239522|OG002|Outcome|[14C]-GSK1278863 25 mg Oral Solution|Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.
11316130|NCT03239522|OG000|Outcome|GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion|Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.
11316131|NCT03239522|EG000|Reported Event|GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion|Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.
11316132|NCT03239522|EG001|Reported Event|[14C]-GSK1278863 25 mg Oral Solution|Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.
11316133|NCT03239574|BG000|Baseline|MightySat Test Group|"The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.~MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study"
11316134|NCT03239574|FG000|Participant Flow|MightySat Test Group|"The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.~MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study"
11316135|NCT03239574|OG000|Outcome|MightySat Test Group|"The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.~MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study"
11316136|NCT03239574|EG000|Reported Event|MightySat Test Group|"The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.~MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study"
11316137|NCT03239665|BG000|Baseline|Pharmacist-led Intervention (PHARM)|"In the PHARM intervention group, participants will be given a 60-minute formal presentation on vaccine-preventable diseases to address knowledge and beliefs related to zoster, pneumonia, and influenza and to address barriers to receiving vaccination. In several studies, it has been demonstrated that those who believe it is wise to receive vaccinations and those that have discussed vaccination with their healthcare provider are more likely to receive a vaccine.~Pharmacist-led Intervention (PHARM): 60 minute didactic lecture about vaccinations."
11316138|NCT03239665|BG001|Baseline|Peer-led Intervention (PEER)|"A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include role-play exercises. In the role-play exercises, 3 vaccination-related scenarios (one for each disease- zoster, pneumonia, and influenza) will be delivered to illustrate situations participants might encounter when interacting with healthcare providers or friends/family.~Peer-led Intervention (PEER): 60 minute peer led small group intervention including skits and other educational material"
11316139|NCT03239665|BG002|Baseline|Total|Total of all reporting groups
11316140|NCT03239665|FG000|Participant Flow|Pharmacist-led Intervention (PHARM)|"In the PHARM intervention group, participants will be given a 60-minute formal presentation on vaccine-preventable diseases to address knowledge and beliefs related to zoster, pneumonia, and influenza and to address barriers to receiving vaccination. In several studies, it has been demonstrated that those who believe it is wise to receive vaccinations and those that have discussed vaccination with their healthcare provider are more likely to receive a vaccine.~Pharmacist-led Intervention (PHARM): 60 minute didactic lecture about vaccinations."
11316141|NCT03239665|FG001|Participant Flow|Peer-led Intervention (PEER)|"A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include role-play exercises. In the role-play exercises, 3 vaccination-related scenarios (one for each disease- zoster, pneumonia, and influenza) will be delivered to illustrate situations participants might encounter when interacting with healthcare providers or friends/family.~Peer-led Intervention (PEER): 60 minute peer led small group intervention including skits and other educational material"
11316142|NCT03239665|OG000|Outcome|Pharmacist-led Intervention (PHARM)|"In the PHARM intervention group, participants will be given a 60-minute formal presentation on vaccine-preventable diseases to address knowledge and beliefs related to zoster, pneumonia, and influenza and to address barriers to receiving vaccination. In several studies, it has been demonstrated that those who believe it is wise to receive vaccinations and those that have discussed vaccination with their healthcare provider are more likely to receive a vaccine.~Pharmacist-led Intervention (PHARM): 60 minute didactic lecture about vaccinations."
10827459|NCT00109876|OG000|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
11335928|NCT03558997|OG002|Outcome|SCIT|Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.
11316143|NCT03239665|OG001|Outcome|Peer-led Intervention (PEER)|"A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include role-play exercises. In the role-play exercises, 3 vaccination-related scenarios (one for each disease- zoster, pneumonia, and influenza) will be delivered to illustrate situations participants might encounter when interacting with healthcare providers or friends/family.~Peer-led Intervention (PEER): 60 minute peer led small group intervention including skits and other educational material"
11316144|NCT03239665|EG000|Reported Event|Pharmacist-led Intervention (PHARM)|"In the PHARM intervention group, participants will be given a 60-minute formal presentation on vaccine-preventable diseases to address knowledge and beliefs related to zoster, pneumonia, and influenza and to address barriers to receiving vaccination. In several studies, it has been demonstrated that those who believe it is wise to receive vaccinations and those that have discussed vaccination with their healthcare provider are more likely to receive a vaccine.~Pharmacist-led Intervention (PHARM): 60 minute didactic lecture about vaccinations."
11316145|NCT03239665|EG001|Reported Event|Peer-led Intervention (PEER)|"A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include role-play exercises. In the role-play exercises, 3 vaccination-related scenarios (one for each disease- zoster, pneumonia, and influenza) will be delivered to illustrate situations participants might encounter when interacting with healthcare providers or friends/family.~Peer-led Intervention (PEER): 60 minute peer led small group intervention including skits and other educational material"
11316146|NCT03239873|BG000|Baseline|VARIVAX PE34 + M-M-R II|VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316147|NCT03239873|BG001|Baseline|VARIVAX (2016 CP) + M-M-R II|2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316148|NCT03239873|BG002|Baseline|Total|Total of all reporting groups
11316149|NCT03239873|FG000|Participant Flow|VARIVAX PE34 + M-M-R II|VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316150|NCT03239873|FG001|Participant Flow|VARIVAX (2016 CP) + M-M-R II|2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316151|NCT03239873|OG000|Outcome|VARIVAX PE34 + M-M-R II|VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316152|NCT03239873|OG001|Outcome|VARIVAX (2016 CP) + M-M-R II|2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316153|NCT03239873|EG000|Reported Event|VARIVAX PE34 + M-M-R II|VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316154|NCT03239873|EG001|Reported Event|VARIVAX (2016 CP) + M-M-R II|2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
11316155|NCT03240081|BG000|Baseline|50mcg Estradiol Cream|"Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~50mcg estradiol cream: Use of study drug nightly"
11316156|NCT03240081|BG001|Baseline|100mcg Estradiol Cream|"Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~100mcg estradiol cream: Use of study drug nightly"
11316157|NCT03240081|BG002|Baseline|Total|Total of all reporting groups
11316158|NCT03240081|FG000|Participant Flow|50mcg Estradiol Cream|"Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~50mcg estradiol cream: Use of study drug nightly"
11316159|NCT03240081|FG001|Participant Flow|100mcg Estradiol Cream|"Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~100mcg estradiol cream: Use of study drug nightly"
11316160|NCT03240081|OG000|Outcome|50mcg Estradiol Cream|"Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~50mcg estradiol cream: Use of study drug nightly"
11316161|NCT03240081|OG001|Outcome|100mcg Estradiol Cream|"Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~100mcg estradiol cream: Use of study drug nightly"
11316162|NCT03240081|EG000|Reported Event|50mcg Estradiol Cream|"Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~50mcg estradiol cream: Use of study drug nightly"
11316163|NCT03240081|EG001|Reported Event|100mcg Estradiol Cream|"Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump~100mcg estradiol cream: Use of study drug nightly"
11316164|NCT03240133|BG000|Baseline|Part 1: Berotralstat (750 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 750 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316165|NCT03240133|BG001|Baseline|Part 2: Berotralstat (500 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 500 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316166|NCT03240133|BG002|Baseline|Part 3: Berotralstat (250 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 250 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316167|NCT03240133|BG003|Baseline|Total|Total of all reporting groups
11316168|NCT03240133|FG000|Participant Flow|Part 1: Berotralstat (750 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 750 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316169|NCT03240133|FG001|Participant Flow|Part 2: Berotralstat (500 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 500 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316170|NCT03240133|FG002|Participant Flow|Part 3: Berotralstat (250 mg) & Placebo Treated HAE Attacks|Each subject treated 3 HAE attacks, 1 with placebo and 2 with 250 mg berotralstat. Placebo vs berotralstat treatment of an HAE attack was assigned by randomization.
11316171|NCT03240133|OG000|Outcome|Part 1: Berotralstat 750 mg - Predose|HAE attack prior to dosing with 750mg berotralstat
11316172|NCT03240133|OG001|Outcome|Part 1: Placebo - Pre-dose|HAE attack prior to dosing with placebo
11316173|NCT03240133|OG002|Outcome|Part 1: Berotralstat 750 mg - 4hr Post-dose|HAE attack 4 hr post dosing with 750mg berotralstat
11316174|NCT03240133|OG003|Outcome|Part 1: Placebo - 4hr Post-dose|HAE attack 4 hr post dosing with placebo
11316175|NCT03240133|OG004|Outcome|Part 2: Berotralstat 500 mg - Predose|HAE attack prior to dosing with 500mg berotralstat
11316176|NCT03240133|OG005|Outcome|Part 2: Placebo - Pre-dose|HAE attack prior to dosing with placebo
11316177|NCT03240133|OG006|Outcome|Part 2: Berotralstat 500 mg - 4hr Post-dose|HAE attack 4 hr post dosing with 50mg berotralstat
11316178|NCT03240133|OG007|Outcome|Part 2: Placebo - 4hr Post-dose|HAE attack 4 hr post dosing with placebo
11316179|NCT03240133|OG008|Outcome|Part 3: Berotralstat 250 mg - Predose|HAE attack prior to dosing with 250mg berotralstat
11316180|NCT03240133|OG009|Outcome|Part 3: Placebo - Pre-dose|HAE attack prior to dosing with placebo
11316181|NCT03240133|OG010|Outcome|Part 3: Berotralstat 250 mg - 4hr Post-dose|HAE attack 4 hr post dosing with 250mg berotralstat
11316182|NCT03240133|OG011|Outcome|Part 3: Placebo - 4hr Post-dose|HAE attack 4 hr post dosing with placebo
11316183|NCT03240133|OG000|Outcome|Part 1: Berotralstat 750 mg|HAE attack treated with 750mg berotralstat
11316184|NCT03240133|OG001|Outcome|Part 1: Placebo|HAE attack treated with placebo
11316185|NCT03240133|OG002|Outcome|Part 2: Berotralstat 500 mg|HAE attack treated with 500mg berotralstat
11316186|NCT03240133|OG003|Outcome|Part 2: Placebo|HAE attack treated with placebo
11316187|NCT03240133|OG004|Outcome|Part 3: Berotralstat 250 mg|HAE attack treated with 250mg berotralstat
11316188|NCT03240133|OG005|Outcome|Part 3: Placebo|HAE attack treated with placebo
11316189|NCT03240133|EG000|Reported Event|Part1: Berotralstat 750 mg|Berotralstat : oral liquid formulation
11316190|NCT03240133|EG001|Reported Event|Part 2: Berotralstat 500 mg|Berotralstat: oral liquid formulation
11316191|NCT03240133|EG002|Reported Event|Part 3: Berotralstat 250 mg|Berotralstat: oral liquid formulation
11316192|NCT03240133|EG003|Reported Event|Parts 1, 2 and 3: Placebo|Placebo: oral liquid formulation to match Berotralstat
11316193|NCT03240575|BG000|Baseline|Tiotropium+Olodaterol (5μg/5μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316194|NCT03240575|BG001|Baseline|Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316195|NCT03240575|BG002|Baseline|Tiotropium+Olodaterol (5μg/5μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316196|NCT03240575|BG003|Baseline|Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316197|NCT03240575|BG004|Baseline|Total|Total of all reporting groups
11316198|NCT03240575|FG000|Participant Flow|Tiotropium+Olodaterol (5μg/5μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316199|NCT03240575|FG001|Participant Flow|Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316200|NCT03240575|FG002|Participant Flow|Tiotropium+Olodaterol (5μg/5μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316201|NCT03240575|FG003|Participant Flow|Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316202|NCT03240575|OG000|Outcome|Tiotropium+Olodaterol (5μg/5μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316203|NCT03240575|OG001|Outcome|Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the main study were not eligible to participate in the DH study.
11316204|NCT03240575|OG002|Outcome|Tiotropium+Olodaterol (5μg/5μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 2.5 microgram (μg) tiotropium and 2.5μg olodaterol (T+O) (total 5μg/5μg) were administered orally once daily in the morning via RESPIMAT inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316205|NCT03240575|OG003|Outcome|Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study|2 inhalations of fixed dose combination (FDC) of 250μg fluticasone propionate and 50μg salmeterol (F+S) (total 500μg/100μg) were administered orally twice daily in the morning and in the evening (12h after morning dose) via Diskus inhaler over a treatment period of 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients enrolled in the DH study were not eligible to participate in the main study.
11316206|NCT03240575|EG000|Reported Event|Tiotropium+Olodaterol (5μg/5μg)|Once daily treatment of orally inhaled tiotropium + olodaterol (T+O) (5μg/5μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
11316207|NCT03240575|EG001|Reported Event|Fluticasone Propionate+Salmeterol (500μg/100μg)|Twice daily treatment of orally inhaled fluticasone propionate + salmeterol (F+S) (250μg/50μg) fixed dose combination (FDC) over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). Patients from Main and DH-study combined.
11316208|NCT03241030|BG000|Baseline|Experimental Group|"Subjects will receive sucralfate~Sucralfate: Will receive 20mg/kg/dose up to 1 gram.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316209|NCT03241030|BG001|Baseline|Placebo Group|"Subjects will receive a placebo~Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316210|NCT03241030|BG002|Baseline|Total|Total of all reporting groups
11316211|NCT03241030|FG000|Participant Flow|Experimental Group|"Subjects will receive sucralfate~Sucralfate: Will receive 20mg/kg/dose up to 1 gram.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316212|NCT03241030|FG001|Participant Flow|Placebo Group|"Subjects will receive a placebo~Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11335929|NCT03558997|OG003|Outcome|Dupilumab + SCIT|Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
10827460|NCT00109876|EG000|Reported Event|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
10827461|NCT00109928|BG000|Baseline|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
10827462|NCT00109928|FG000|Participant Flow|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
11316213|NCT03241030|OG000|Outcome|Experimental Group|"Subjects will receive sucralfate~Sucralfate: Will receive 20mg/kg/dose up to 1 gram.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316214|NCT03241030|OG001|Outcome|Placebo Group|"Subjects will receive a placebo~Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316215|NCT03241030|EG000|Reported Event|Experimental Group|"Subjects will receive sucralfate~Sucralfate: Will receive 20mg/kg/dose up to 1 gram.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316216|NCT03241030|EG001|Reported Event|Placebo Group|"Subjects will receive a placebo~Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.~Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.~Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo."
11316217|NCT03241342|BG000|Baseline|1 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316218|NCT03241342|BG001|Baseline|3 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316219|NCT03241342|BG002|Baseline|Matching Placebo|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024."
11316220|NCT03241342|BG003|Baseline|Total|Total of all reporting groups
11316221|NCT03241342|FG000|Participant Flow|1 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316222|NCT03241342|FG001|Participant Flow|3 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316223|NCT03241342|FG002|Participant Flow|Matching Placebo|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024."
11316224|NCT03241342|OG000|Outcome|1 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316225|NCT03241342|OG001|Outcome|3 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316226|NCT03241342|OG002|Outcome|Matching Placebo|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024."
11316227|NCT03241342|EG000|Reported Event|1 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
11316228|NCT03241342|EG001|Reported Event|3 mg GTx-024|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024."
10827463|NCT00109928|OG000|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
10827464|NCT00109928|OG000|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
10827465|NCT00109928|EG000|Reported Event|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
10827466|NCT00109967|BG000|Baseline|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
10827467|NCT00109967|BG001|Baseline|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
10827468|NCT00109967|BG002|Baseline|Total|Total of all reporting groups
10827469|NCT00109967|FG000|Participant Flow|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
10827470|NCT00109967|FG001|Participant Flow|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
10827471|NCT00109967|OG000|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
10827472|NCT00109967|OG001|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
10827473|NCT00109967|EG000|Reported Event|Group I: Rituximab Sensitive|temsirolimus: 25 mg given IV
10827474|NCT00109967|EG001|Reported Event|Group II: Rituximab Refractory|temsirolimus: 25 mg given IV
10827475|NCT00110019|BG000|Baseline|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
10827476|NCT00110019|BG001|Baseline|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
10827477|NCT00110019|BG002|Baseline|Total|Total of all reporting groups
10827478|NCT00110019|FG000|Participant Flow|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
10827479|NCT00110019|FG001|Participant Flow|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
10827480|NCT00110019|OG000|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
10827481|NCT00110019|OG001|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
11316229|NCT03241342|EG002|Reported Event|Matching Placebo|"Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.~Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024."
11316230|NCT03241368|BG000|Baseline|MRE, Patency Capsule (if Needed), CE, and IC|"Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.~If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.~Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).~After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."
11316231|NCT03241368|FG000|Participant Flow|MRE, Patency Capsule (if Needed), CE, and IC|"Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.~If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency not confirmed by MRE or patency capsule, subject is discontinued from study.~Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final polyethylene glycol (PEG) ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).~After CE procedure (either same or following day), subject will undergo IC. If IC is done the following day, subject will stay on clear liquid diet (or NPO (nothing by mouth), per physician discretion)."
11316232|NCT03241368|OG000|Outcome|MRE, Patency Capsule (if Needed), CE, and IC|"Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.~If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.~Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).~After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."
11316233|NCT03241368|OG000|Outcome|MRE, Patency Capsule (if Needed), CE, and IC|"Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.~Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure"
11316234|NCT03241368|EG000|Reported Event|MRE, Patency Capsule (if Needed), CE, and IC|"Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.~Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure"
11316235|NCT03241485|BG000|Baseline|Placebo|42 patients were randomized to this group
11316236|NCT03241485|BG001|Baseline|Intrathecal Morphine|37 patients were randomized to this group
11316237|NCT03241485|BG002|Baseline|Total|Total of all reporting groups
11316238|NCT03241485|FG000|Participant Flow|Placebo|42 patients were randomized to the intrathecal placebo group. This group received a normal saline injected in the spinal spice, prior to surgery.
11316239|NCT03241485|FG001|Participant Flow|Intrathecal Morphine|37 patients were randomized to the intrathecal morphine group. This group received 5 micrograms/kilogram of intrathecal morphine administered in the spinal space
11316240|NCT03241485|OG000|Outcome|Placebo|36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.
11316241|NCT03241485|OG001|Outcome|Morphine|Intrathecal morphine group
11316242|NCT03241485|OG000|Outcome|Placebo|Intrathecal saline group
11316243|NCT03241485|OG001|Outcome|Morphine|Intrathecal Morphine Group
11316244|NCT03241485|OG000|Outcome|Placebo (Nausea)|Intrathecal saline group
11316245|NCT03241485|OG001|Outcome|Morphine|Intrathecal Morphine group
11316246|NCT03241485|EG000|Reported Event|Placebo|Intrathecal Saline Group
11316247|NCT03241485|EG001|Reported Event|Morphine|5 micrograms/kilogram of intrathecal morphine.
11333909|NCT03521115|EG000|Reported Event|Smart Choices 4 Teens|"A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component.~Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other."
11333910|NCT03521115|EG001|Reported Event|Control Condition|This group was provided with websites where information was available regarding the same topics.
11335930|NCT03558997|EG000|Reported Event|Placebo|Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 to 7 days.
11335931|NCT03558997|EG001|Reported Event|Dupilumab|Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11316248|NCT03241810|BG000|Baseline|Arm A (Experimental): Seribantumab and Fulvestrant|"Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316249|NCT03241810|BG001|Baseline|Arm B (Control): Placebo and Fulvestrant|"Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316250|NCT03241810|BG002|Baseline|Total|Total of all reporting groups
11316251|NCT03241810|FG000|Participant Flow|Arm A (Experimental): Seribantumab and Fulvestrant|"Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316252|NCT03241810|FG001|Participant Flow|Arm B (Control): Placebo and Fulvestrant|"Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316253|NCT03241810|OG000|Outcome|Arm A (Experimental): Seribantumab and Fulvestrant|Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle
11316254|NCT03241810|OG001|Outcome|Arm B (Control): Placebo and Fulvestrant|"Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316255|NCT03241810|OG000|Outcome|Arm A (Experimental): Seribantumab and Fulvestrant|"Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316256|NCT03241810|EG000|Reported Event|Arm A (Experimental): Seribantumab and Fulvestrant|"Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316257|NCT03241810|EG001|Reported Event|Arm B (Control): Placebo and Fulvestrant|"Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle~Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle"
11316258|NCT03241862|BG000|Baseline|Restylane® Silk|"All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.~Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids."
11316259|NCT03241862|FG000|Participant Flow|Restylane® Silk|"All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.~Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids."
11316260|NCT03241862|OG000|Outcome|Restylane® Silk|"All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.~Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids."
11316261|NCT03241862|EG000|Reported Event|Restylane® Silk|"All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.~Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids."
11316262|NCT03241927|BG000|Baseline|Pembrolizumab|"200 mg IV infusion every 3 weeks~Pembrolizumab: Day 1 of each 3 week cycle"
11316263|NCT03241927|FG000|Participant Flow|Pembrolizumab|"200 mg IV infusion every 3 weeks~Pembrolizumab: Day 1 of each 3 week cycle"
11316264|NCT03241927|FG001|Participant Flow|Healthy Donors|Healthy participants
11316265|NCT03241927|OG000|Outcome|Pembrolizumab|"200 mg IV infusion every 3 weeks~Pembrolizumab: Day 1 of each 3 week cycle"
11316266|NCT03241927|OG001|Outcome|Healthy Donors|Healthy participants
11316267|NCT03241927|EG000|Reported Event|Pembrolizumab|"200 mg IV infusion every 3 weeks~Pembrolizumab: Day 1 of each 3 week cycle"
11316268|NCT03241927|EG001|Reported Event|Healthy Control|Healthy Participants
11316269|NCT03242018|BG000|Baseline|Placebo|Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.
11316270|NCT03242018|BG001|Baseline|Sotagliflozin 200 mg|Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.
11316271|NCT03242018|BG002|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
11316272|NCT03242018|BG003|Baseline|Total|Total of all reporting groups
11316273|NCT03242018|FG000|Participant Flow|Placebo|Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.
11316274|NCT03242018|FG001|Participant Flow|Sotagliflozin 200 mg|Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.
11316275|NCT03242018|FG002|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
11316276|NCT03242018|OG000|Outcome|Placebo|Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.
11316277|NCT03242018|OG001|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
11316278|NCT03242018|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.
11316279|NCT03242018|OG002|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
11316280|NCT03242018|EG000|Reported Event|Placebo|Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance) orally once daily for up to 56.3 weeks.
11316281|NCT03242018|EG001|Reported Event|Sotagliflozin 200 mg|Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 55.3 weeks.
11316282|NCT03242018|EG002|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
11316283|NCT03242148|BG000|Baseline|Toffee Nasal Pillows Mask|"Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm~Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm."
11316284|NCT03242148|FG000|Participant Flow|Toffee Nasal Pillows Mask|"Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm~Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm."
11316285|NCT03242148|OG000|Outcome|Toffee Nasal Pillows Mask|"Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm~Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm."
11316286|NCT03242148|EG000|Reported Event|Toffee Nasal Pillows Mask|"Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm~Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm."
11316287|NCT03242252|BG000|Baseline|Placebo|Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
11316288|NCT03242252|BG001|Baseline|Sotagliflozin 200 mg|Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
11316289|NCT03242252|BG002|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
11316290|NCT03242252|BG003|Baseline|Total|Total of all reporting groups
11316291|NCT03242252|FG000|Participant Flow|Placebo|Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
11316292|NCT03242252|FG001|Participant Flow|Sotagliflozin 200 mg|Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
11316293|NCT03242252|FG002|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
11316294|NCT03242252|OG000|Outcome|Placebo|Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
11316295|NCT03242252|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
11316296|NCT03242252|OG002|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
11316297|NCT03242252|OG000|Outcome|Placebo|Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks
11316298|NCT03242252|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
11316299|NCT03242252|OG002|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
11316300|NCT03242252|OG000|Outcome|Placebo|Following a 2-week run-in phase, participants received two placebo tablets (identical to Sotagliflozin 200 mg in appearance), orally once daily for up to 54 weeks.
11316301|NCT03242252|OG001|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in phase, participants received two tablets, 1 Sotagliflozin 200 mg tablet and 1 placebo tablet (identical to Sotagliflozin 200 mg in appearance), orally once daily for up to 58 weeks. Four participants randomized to Sotagliflozin 400 mg were dosed with both Sotagliflozin 200 mg and 400 mg. These participants were included in the Sotagliflozin 200 mg arm in the safety population.
11316302|NCT03242252|OG002|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in phase, participants received Sotagliflozin 400 mg, administered as two 200 mg Sotagliflozin tablets, orally once daily for up to 60 weeks. Four participants randomized to Sotagliflozin 400 mg were dosed with both Sotagliflozin 200 mg and 400 mg. These participants were included in the Sotagliflozin 200 mg arm in the safety population.
11316303|NCT03242252|EG000|Reported Event|Placebo|Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
11316304|NCT03242252|EG001|Reported Event|Sotagliflozin 200 mg|Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
11316305|NCT03242252|EG002|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
11316306|NCT03242408|BG000|Baseline|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day~LPCN 1021: Oral testosterone undecanoate"
11316307|NCT03242408|FG000|Participant Flow|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day~LPCN 1021: Oral testosterone undecanoate"
11316308|NCT03242408|OG000|Outcome|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day~LPCN 1021: Oral testosterone undecanoate"
10827482|NCT00110019|EG000|Reported Event|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
11316309|NCT03242408|EG000|Reported Event|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day~LPCN 1021: Oral testosterone undecanoate"
11316310|NCT03242434|BG000|Baseline|Healthy Participants|Healthy participants were invited to donate a blood sample for biomarker measurement on day one. They were also requested to undergo measurements of intestinal permeability by taking a 100 milliliter (mL) solution of lactulose (5 gram [g]) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1, 8 and 15 followed by a 24 hour urine collection.
11316311|NCT03242434|BG001|Baseline|Thermally Injured Participants|Participants were invited to undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13.
11316312|NCT03242434|BG002|Baseline|Total|Total of all reporting groups
11316313|NCT03242434|FG000|Participant Flow|Healthy Participants|Healthy participants were invited to donate a blood sample for biomarker measurement on day one. They were also requested to undergo measurements of intestinal permeability by taking a 100 milliliter (mL) solution of lactulose (5 gram [g]) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1, 8 and 15 followed by a 24 hour urine collection.
11316314|NCT03242434|FG001|Participant Flow|Thermal Injury Participants|Participants were invited to undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13.
11316315|NCT03242434|OG000|Outcome|Healthy Participants|Healthy participants were invited to donate a blood sample for biomarker measurement on day one. They were also requested to undergo measurements of intestinal permeability by taking a 100 milliliter (mL) solution of lactulose (5 gram [g]) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1, 8 and 15 followed by a 24 hour urine collection.
11316316|NCT03242434|OG001|Outcome|Thermally Injured Participants|Participants were invited undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13.
11316317|NCT03242434|OG000|Outcome|Thermally Injured Participants|Participants were invited undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13.
11316318|NCT03242434|EG000|Reported Event|Healthy Participants|Healthy participants were invited to donate a blood sample for biomarker measurement on day one. They were also requested to undergo measurements of intestinal permeability by taking a 100 milliliter (mL) solution of lactulose (5 gram [g]) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1, 8 and 15 followed by a 24 hour urine collection.
11316319|NCT03242434|EG001|Reported Event|Thermally Injured Participants|Participants were invited to undergo measurements of intestinal permeability by taking a 100 mL solution of lactulose (5 g) and mannitol (2g) along with 3 capsules (2g) of sucralose on days 1,3,5,7,9,11 and 13.
11316320|NCT03242590|BG000|Baseline|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.~LPCN 1021: Oral testosterone undecanoate"
11316321|NCT03242590|FG000|Participant Flow|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.~LPCN 1021: Oral testosterone undecanoate"
11316322|NCT03242590|OG000|Outcome|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.~LPCN 1021: Oral testosterone undecanoate"
11316323|NCT03242590|EG000|Reported Event|Oral Testosterone Undecanoate, LPCN 1021|"Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.~LPCN 1021: Oral testosterone undecanoate"
11316324|NCT03242759|BG000|Baseline|Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.
11316325|NCT03242759|BG001|Baseline|Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
11316326|NCT03242759|BG002|Baseline|Total|Total of all reporting groups
11316327|NCT03242759|FG000|Participant Flow|Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.
11316328|NCT03242759|FG001|Participant Flow|Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
11316329|NCT03242759|OG000|Outcome|Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.
11316330|NCT03242759|OG001|Outcome|Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
11316331|NCT03242759|EG000|Reported Event|Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.
11316332|NCT03242759|EG001|Reported Event|Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug|Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
11316333|NCT03242863|BG000|Baseline|Entire Study Population|Enrolled participants who completed the study
11316334|NCT03242863|FG000|Participant Flow|Con First, Then Add, Then Sub|Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Control, then Addition, then Substitution.
11316335|NCT03242863|FG001|Participant Flow|Add First, Then Sub, Then Con|Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Addition, then Substitution, then Control.
11316336|NCT03242863|FG002|Participant Flow|Sub First, Then Con, Then Add|Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Control, then Addition.
11316337|NCT03242863|FG003|Participant Flow|Con First, Then Sub, Then Add|Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Control, then Substitution, then Addition.
11316338|NCT03242863|FG004|Participant Flow|Add First, Then Con, Then Sub|Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Addition, then Control, then Substitution.
10827483|NCT00110019|EG001|Reported Event|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
10827484|NCT00110084|BG000|Baseline|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
10827485|NCT00110084|FG000|Participant Flow|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
10827486|NCT00110084|OG000|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
10827487|NCT00110084|EG000|Reported Event|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
10827488|NCT00110136|BG000|Baseline|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
10827489|NCT00110136|FG000|Participant Flow|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
10827490|NCT00110136|OG000|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
10827491|NCT00110136|OG000|Outcome|St. John's Wort|"Patients given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
10827492|NCT00110136|EG000|Reported Event|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
10827493|NCT00110149|BG000|Baseline|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
10827494|NCT00110149|FG000|Participant Flow|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
10827495|NCT00110149|OG000|Outcome|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|patient un treated NHL, who were then treated with the Rituximab and Y-90 Ibritumomab Tiuxetan.
10827496|NCT00110149|OG000|Outcome|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
10827497|NCT00110149|EG000|Reported Event|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
11316339|NCT03242863|FG005|Participant Flow|Sub First, Then Add, Then Con|Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Addition, then Control.
11316340|NCT03242863|OG000|Outcome|Control|Baseline proportions of high and low energy dense foods.
11316341|NCT03242863|OG001|Outcome|Addition|Increased portion of low energy dense foods.
11316342|NCT03242863|OG002|Outcome|Substitution|Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
11316343|NCT03242863|EG000|Reported Event|Control|All participants during the Control condition
11316344|NCT03242863|EG001|Reported Event|Addition|All participants during the Addition condition
11316345|NCT03242863|EG002|Reported Event|Substitution|All participants during the Substitution condition
11316346|NCT03242928|BG000|Baseline|AFQ056|Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
11316347|NCT03242928|BG001|Baseline|Placebo|Matching tablet of placebo taken orally BID
11316348|NCT03242928|BG002|Baseline|Total|Total of all reporting groups
11316349|NCT03242928|FG000|Participant Flow|AFQ056|Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
11316350|NCT03242928|FG001|Participant Flow|Placebo|Matching tablet of placebo taken orally BID
11316351|NCT03242928|OG000|Outcome|AFQ056|Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
11316352|NCT03242928|OG001|Outcome|Placebo|Matching tablet of placebo taken orally BID
11316353|NCT03242928|EG000|Reported Event|AFQ056|Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
11316354|NCT03242928|EG001|Reported Event|Placebo|Matching tablet of placebo taken orally BID
11316355|NCT03242941|BG000|Baseline|Paroxymal and Persistent AF Patients|"Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.~Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination."
11316356|NCT03242941|FG000|Participant Flow|Persisten and Paroxymal AF Patients|"Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.~Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination."
11316357|NCT03242941|OG000|Outcome|Paroxymal and Persistent AF Patients|"Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.~Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination."
11316358|NCT03242941|OG000|Outcome|Paroxymal or Persistent AF Patients|"Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.~Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well"
11316359|NCT03242941|EG000|Reported Event|Paroxymal and Persistent AF Patients|"Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.~Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination."
11316360|NCT03242954|BG000|Baseline|Adolescents: Consent Condition 1|"Autonomous minor consent~Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial."
11316361|NCT03242954|BG001|Baseline|Adolescents: Consent Condition 2|"Adult permission required~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial."
11316362|NCT03242954|BG002|Baseline|Adolescents: Consent Condition 3|"Parental permission required~Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316363|NCT03242954|BG003|Baseline|Parents: Consent Conditions 1-3|"Autonomous minor consent, adult permission required, and parental permission required~Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.~Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316364|NCT03242954|BG004|Baseline|Total|Total of all reporting groups
11316365|NCT03242954|FG000|Participant Flow|Adolescents: Consent Condition 1|"Autonomous consent~Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial."
11316366|NCT03242954|FG001|Participant Flow|Adolescents: Consent Condition 2|"Adult permission required~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial."
11316367|NCT03242954|FG002|Participant Flow|Adolescents: Consent Condition 3|"Parental permission required~Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316368|NCT03242954|FG003|Participant Flow|Parents: Consent Conditions 1-3|"Autonomous consent, Adult permission required and Parental permission required~Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.~Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316369|NCT03242954|OG000|Outcome|Adolescents: Consent Condition 1|"Autonomous minor consent~Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial."
11316370|NCT03242954|OG001|Outcome|Adolescents: Consent Condition 2|"Adult permission required~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial."
11316371|NCT03242954|OG002|Outcome|Adolescents: Consent Condition 3|"Parental permission required~Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316372|NCT03242954|OG000|Outcome|Parents: Consent Conditions 1-3|"Autonomous minor consent, Adult permission required, and Parental permission required~Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.~Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316373|NCT03242954|EG000|Reported Event|Adolescents: Consent Condition 1|"Autonomous minor consent~Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial."
11316374|NCT03242954|EG001|Reported Event|Adolescents: Consent Condition 2|"Adult permission required~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial."
11316375|NCT03242954|EG002|Reported Event|Adolescents: Consent Condition 3|"Parental permission required~Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316376|NCT03242954|EG003|Reported Event|Parents: Consent Conditions 1-3|"Autonomous minor consent, adult permission required, and parental permission required~Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.~Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.~Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial."
11316377|NCT03243084|BG000|Baseline|Sham Then Active 10 Hz tACS|At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS
11316378|NCT03243084|BG001|Baseline|Active 10 Hz Then Sham tACS|At session 1 this group received active 10Hz tACS and at session 2 they received sham 10Hz tACS
11316379|NCT03243084|BG002|Baseline|Total|Total of all reporting groups
11316380|NCT03243084|FG000|Participant Flow|Sham Then Active 10 Hz tACS|At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS
11316381|NCT03243084|FG001|Participant Flow|Active 10 Hz Then Sham tACS|At session 1 this group received active 10Hz tACS and at session 2 they received sham tACS
11316382|NCT03243084|OG000|Outcome|Sham tACS|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session"
10827498|NCT00110214|BG000|Baseline|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
11316383|NCT03243084|OG001|Outcome|Active10 Hz tACS|"Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied"
11316384|NCT03243084|OG001|Outcome|Active 10 Hz tACS|"Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied"
11316385|NCT03243084|EG000|Reported Event|Sham tACS|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session"
11316386|NCT03243084|EG001|Reported Event|Active 10 Hz tACS|"Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11316387|NCT03243305|BG000|Baseline|Interventional|"This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.~AMPHORA: non-hormonal contraceptive vaginal gel"
11316388|NCT03243305|FG000|Participant Flow|Interventional|"This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.~AMPHORA: non-hormonal contraceptive vaginal gel"
11316389|NCT03243305|OG000|Outcome|Interventional|"This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.~AMPHORA: non-hormonal contraceptive vaginal gel"
11316390|NCT03243305|EG000|Reported Event|Interventional|"This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.~AMPHORA: non-hormonal contraceptive vaginal gel"
11316391|NCT03243630|BG000|Baseline|Overall Study|The baseline characteristics has been provided for the entire study. Test sessions were randomized by arm, each test session was a different arm.
11316392|NCT03243630|FG000|Participant Flow|Study Cohort|"In each test session, the flavor was randomly assigned and delivered via the e-cigarette. Then, participants were randomly assigned to receive one intravenous delivery of saline, and two intravenous deliveries of nicotine (3.6 mcg/kg and 7 mcg/kg or 0.25 mg/70 kg and 0.5 mg/70kg), one hour apart.~Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)~Green Apple Flavor + IV saline Green Apple Flavor + IV nicotine (0.25mg/70kg) Green Apple Flavor + IV nicotine (0.5mg/70kg)~Menthol plus Green Apple Flavor + IV saline Menthol plus Green Apple Flavor + IV nicotine (0.25mg/70kg) Menthol plus Green Apple Flavor + IV nicotine (0.5mg/70kg)"
11316393|NCT03243630|OG000|Outcome|Menthol E-liquid|"Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
11316394|NCT03243630|OG001|Outcome|Green Apple E-liquid|"Green apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
11316395|NCT03243630|OG002|Outcome|Green Apple and Menthol E-liquid|"Green apple and menthol + IV saline Green apple and menthol + IV nicotine (0.25mg/70kg) Green apple and menthol + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
11316396|NCT03243630|EG000|Reported Event|Menthol E-liquid|"Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
10827499|NCT00110214|BG001|Baseline|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
11316397|NCT03243630|EG001|Reported Event|Green Apple E-liquid|"Green apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
11316398|NCT03243630|EG002|Reported Event|Green Apple and Menthol E-liquid|"Green apple and menthol + IV saline Green apple and menthol + IV nicotine (0.25mg/70kg) Green apple and menthol + IV nicotine (0.5mg/70kg)~IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg~Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator~green apple: green apple will be added to the menthol flavor~green apple and menthol: menthol and green apple will be the active intervention"
11316399|NCT03243981|BG000|Baseline|Skintyte|All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.
11316400|NCT03243981|FG000|Participant Flow|Skintyte|All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.
11316401|NCT03243981|OG000|Outcome|BBL + SPL590 vs Untreated|"Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm)~BBL = broadband light; SPL = sequentially pulsed light"
10827500|NCT00110214|BG002|Baseline|Total|Total of all reporting groups
10827501|NCT00110214|FG000|Participant Flow|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
11316402|NCT03243981|OG001|Outcome|SPL800 (SkinTite 2) vs Untreated|"Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm)~SPL800 = SkinTite 2"
11316403|NCT03243981|OG000|Outcome|BBL + SPL590|Treatment on proximal forearm
11316404|NCT03243981|OG001|Outcome|SPL800|Treatment on distal forearm
11316405|NCT03243981|EG000|Reported Event|BBL + SPL590|Treatment on proximal forearm
11316406|NCT03243981|EG001|Reported Event|SPL800|Treatment on distal forearm
11316407|NCT03243981|EG002|Reported Event|Untreated|Untreated area on mid-forearm
11316408|NCT03244618|BG000|Baseline|CSSP Toothpaste|Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316409|NCT03244618|BG001|Baseline|Fluoride Toothpaste|Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316410|NCT03244618|BG002|Baseline|Total|Total of all reporting groups
11316411|NCT03244618|FG000|Participant Flow|CSSP Toothpaste|Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316412|NCT03244618|FG001|Participant Flow|Fluoride Toothpaste|Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316413|NCT03244618|OG000|Outcome|CSSP Toothpaste|Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316414|NCT03244618|OG001|Outcome|Fluoride Toothpaste|Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316415|NCT03244618|EG000|Reported Event|CSSP Toothpaste|Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316416|NCT03244618|EG001|Reported Event|Fluoride Toothpaste|Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
11316417|NCT03244800|BG000|Baseline|Placebo Cohort 1|Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
11316418|NCT03244800|BG001|Baseline|MEDI0382 Cohort 1|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
11316419|NCT03244800|BG002|Baseline|Placebo Cohort 2|Participants received placebo matching with MEDI0382 SC once daily for 49 days.
11316420|NCT03244800|BG003|Baseline|MEDI0382 Cohort 2|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
11316421|NCT03244800|BG004|Baseline|TOTAL|Total of all reporting groups
11316422|NCT03244800|FG000|Participant Flow|Placebo Cohort 1|Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
11316423|NCT03244800|FG001|Participant Flow|MEDI0382 Cohort 1|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
11316424|NCT03244800|FG002|Participant Flow|Placebo Cohort 2|Participants received placebo matching with MEDI0382 SC once daily for 49 days.
11316425|NCT03244800|FG003|Participant Flow|MEDI0382 Cohort 2|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
11316426|NCT03244800|OG000|Outcome|Placebo Cohort 1|Participants received placebo matching with MEDI0382 SC once daily for 49 days.
11316427|NCT03244800|OG001|Outcome|MEDI0382 Cohort 1|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
11316428|NCT03244800|OG000|Outcome|Placebo Cohort 1|Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
11316429|NCT03244800|OG002|Outcome|Placebo Cohort 2|Participants received placebo matching with MEDI0382 SC once daily for 49 days.
11316430|NCT03244800|OG003|Outcome|MEDI0382 Cohort 2|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
10827502|NCT00110214|FG001|Participant Flow|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
11316431|NCT03244800|OG000|Outcome|MEDI0382 Cohort 1|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
11316432|NCT03244800|OG000|Outcome|MEDI0382 Cohort 2|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
11316433|NCT03244800|EG000|Reported Event|Placebo Cohort 1|Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
11316434|NCT03244800|EG001|Reported Event|MEDI0382 Cohort 1|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
11316435|NCT03244800|EG002|Reported Event|Placebo Cohort 2|Participants received placebo matching with MEDI0382 SC once daily for 49 days.
11316436|NCT03244800|EG003|Reported Event|MEDI0382 Cohort 2|Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
11316437|NCT03244865|BG000|Baseline|Pregnant Females|"All patients admitted to the Labor & Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.~Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.~LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line."
11316438|NCT03244865|FG000|Participant Flow|Pregnant Females|"All patients admitted to the Labor & Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.~Nothing is required of the participants. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.~LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line."
11316439|NCT03244865|OG000|Outcome|Pregnant Females|"There is only one arm in this study. All monitored patients admitted to Labor & Delivery at UF Health, are eligible for inclusion in the study except minors and those unable to consent for themselves. They are non-invasively monitored for 1 to several hours. The information obtained is not used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.~All subjects in the study maintain the standard CTG monitoring they are using prior to enrollment in the study. The LaborView Electronic Fetal Monitor is added to the subject and both standard CTG FHR and LaborView FHR are collected simultaneously. LaborView electrode application sites are prepared to reduce skin impedance, and electrodes are applied to the maternal abdomen. The data collection laptop collects data from the standard monitor via serial port of the CTG and from LaborView via USB. The comparison of data is performed off-line."
11316440|NCT03244865|EG000|Reported Event|Pregnant Females|"All patients admitted to the Labor & Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.~LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.~Nothing is required of the participants. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus."
11316441|NCT03244917|BG000|Baseline|TRAIN-AD|Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
11316442|NCT03244917|BG001|Baseline|Control|Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
11316443|NCT03244917|BG002|Baseline|Total|Total of all reporting groups
10827503|NCT00110214|OG000|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
11316444|NCT03244917|FG000|Participant Flow|TRAIN-AD|Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
11316445|NCT03244917|FG001|Participant Flow|Control|Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
11316446|NCT03244917|OG000|Outcome|TRAIN-AD|Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
11316447|NCT03244917|OG001|Outcome|Control|Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
11316448|NCT03244917|EG000|Reported Event|TRAIN-AD|Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
11316449|NCT03244917|EG001|Reported Event|Control|Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
10827504|NCT00110214|OG001|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
11316450|NCT03245372|BG000|Baseline|Standard Care|"Basic intraoperative hemodynamic objectives~Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation)."
11316451|NCT03245372|BG001|Baseline|Goal Directed Therapy|"Target value is a cardiac index equal or superior to 2.2 l/min/m2.~Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index."
11316452|NCT03245372|BG002|Baseline|Total|Total of all reporting groups
11316453|NCT03245372|FG000|Participant Flow|Standard Care|"Basic intraoperative hemodynamic objectives~Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation)."
11316454|NCT03245372|FG001|Participant Flow|Goal Directed Therapy|"Target value is a cardiac index equal or superior to 2.2 l/min/m2.~Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index."
11316455|NCT03245372|OG000|Outcome|Standard Care|"Basic intraoperative hemodynamic objectives~Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation)."
11316456|NCT03245372|OG001|Outcome|Goal Directed Therapy|"Target value is a cardiac index equal or superior to 2.2 l/min/m2.~Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index."
11316457|NCT03245372|EG000|Reported Event|Standard Care|"Basic intraoperative hemodynamic objectives~Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation)."
11316458|NCT03245372|EG001|Reported Event|Goal Directed Therapy|"Target value is a cardiac index equal or superior to 2.2 l/min/m2.~Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index."
11316459|NCT03245398|BG000|Baseline|Single 500 mg Dose of Mebendazole|"In the morning of day 1 each child in this treatment arm received a 500 mg tablet of mebendazole plus one 100 mg placebo tablet. In the afternoon of day 1 they only received the placebo. In day 2 and 3 each child received one placebo tablet twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316460|NCT03245398|BG001|Baseline|Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole|"In the morning of day 1 each child in this treatment arm received a 100 mg tablet of mebendazole plus one 500 mg placebo tablet. In the afternoon of day 1 they only received the 100 mg tablet of mebendazole. In day 2 and 3 each child received one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316461|NCT03245398|BG002|Baseline|Total|Total of all reporting groups
11316462|NCT03245398|FG000|Participant Flow|Single 500 mg Dose of Mebendazole|"In the morning of day 1 each child in this treatment arm received a 500 mg tablet of mebendazole plus one 100 mg placebo tablet. In the afternoon of day 1 they only received the placebo. In day 2 and 3 each child received one placebo tablet twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316463|NCT03245398|FG001|Participant Flow|Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole|"In the morning of day 1 each child in this treatment arm received a 100 mg tablet of mebendazole plus one 500 mg placebo tablet. In the afternoon of day 1 they only received the 100 mg tablet of mebendazole. In day 2 and 3 each child received one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316464|NCT03245398|OG000|Outcome|Single 500 mg Dose of Mebendazole|"In the morning of day 1 each child in this treatment arm received a 500 mg tablet of mebendazole plus one 100 mg placebo tablet. In the afternoon of day 1 they only received the placebo. In day 2 and 3 each child received one placebo tablet twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316465|NCT03245398|OG001|Outcome|Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole|"In the morning of day 1 each child in this treatment arm received a 100 mg tablet of mebendazole plus one 500 mg placebo tablet. In the afternoon of day 1 they only received the 100 mg tablet of mebendazole. In day 2 and 3 each child received one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316466|NCT03245398|OG000|Outcome|Single Dose of Mebendazole|"In day 1 each child in this treatment arm will receive a 500 mg tablet of mebendazole plus one 100 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the placebo. In day 2 and 3 each child will receive one placebo twice a day (in the morning and in the evening)~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11335932|NCT03558997|EG002|Reported Event|SCIT|Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 to 7 days.
11316467|NCT03245398|OG001|Outcome|Multiple Dose of Mebendazole|"In day 1 each child in this treatment arm will receive a 100 mg tablet of mebendazole plus one 500 mg placebo tablet in the morning. In the afternoon of day 1 they will only receive the 100 mg tablet of mebendazole. In day 2 and 3 each child will receive one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316468|NCT03245398|EG000|Reported Event|Single 500 mg Dose of Mebendazole|"In the morning of day 1 each child in this treatment arm received a 500 mg tablet of mebendazole plus one 100 mg placebo tablet. In the afternoon of day 1 they only received the placebo. In day 2 and 3 each child received one placebo tablet twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316469|NCT03245398|EG001|Reported Event|Multiple (Bid for 3 Days) Dose of 100 mg Mebendazole|"In the morning of day 1 each child in this treatment arm received a 100 mg tablet of mebendazole plus one 500 mg placebo tablet. In the afternoon of day 1 they only received the 100 mg tablet of mebendazole. In day 2 and 3 each child received one 100 mg tablet of mebendazole twice a day (in the morning and in the evening).~Treatment with one of the two regimens of mebendazole: Once in the morning and once in the evening for 3 consecutive days"
11316470|NCT03245463|BG000|Baseline|Teaching Method A|"Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.~Educational handout: The educational handout will include information on self-management strategies.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316471|NCT03245463|BG001|Baseline|Teaching Method B|"Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).~Educational handout: The educational handout will include information on self-management strategies.~Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316472|NCT03245463|BG002|Baseline|Total|Total of all reporting groups
11316473|NCT03245463|FG000|Participant Flow|Teaching Method A|"Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.~Educational handout: The educational handout will include information on self-management strategies.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316474|NCT03245463|FG001|Participant Flow|Teaching Method B|"Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).~Educational handout: The educational handout will include information on self-management strategies.~Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316475|NCT03245463|OG000|Outcome|Teaching Method A|"Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.~Educational handout: The educational handout will include information on self-management strategies.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316476|NCT03245463|OG001|Outcome|Teaching Method B|"Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).~Educational handout: The educational handout will include information on self-management strategies.~Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316477|NCT03245463|EG000|Reported Event|Teaching Method A|"Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.~Educational handout: The educational handout will include information on self-management strategies.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
10827505|NCT00110214|EG000|Reported Event|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
10827506|NCT00110214|EG001|Reported Event|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
10827507|NCT00110266|BG000|Baseline|Deferasirox|Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10848561|NCT00290472|BG001|Baseline|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
11316478|NCT03245463|EG001|Reported Event|Teaching Method B|"Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).~Educational handout: The educational handout will include information on self-management strategies.~Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.~Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria."
11316479|NCT03245619|BG000|Baseline|Part A: Placebo|Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
11316480|NCT03245619|BG001|Baseline|Part A-Cohort 1: GSK3335065 0.1 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
11316481|NCT03245619|BG002|Baseline|Part A-Cohort 2: GSK3335065 0.25 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
11316482|NCT03245619|BG003|Baseline|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316483|NCT03245619|BG004|Baseline|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316484|NCT03245619|BG005|Baseline|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316485|NCT03245619|BG006|Baseline|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316486|NCT03245619|BG007|Baseline|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316487|NCT03245619|BG008|Baseline|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316488|NCT03245619|BG009|Baseline|Part B: Placebo|Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
11316489|NCT03245619|BG010|Baseline|Part B-Cohort 9: 0.14 mg IV Bolus+0.012 mg/Hour IV Infusion|Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.012 mg/hour for 7 days.
11316490|NCT03245619|BG011|Baseline|Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
11316491|NCT03245619|BG012|Baseline|Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
11316492|NCT03245619|BG013|Baseline|Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
11316493|NCT03245619|BG014|Baseline|Part C: Placebo|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
11316494|NCT03245619|BG015|Baseline|Part C-Cohort 13: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
11316495|NCT03245619|BG016|Baseline|Part C-Cohort 14: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
11316496|NCT03245619|BG017|Baseline|Total|Total of all reporting groups
11316497|NCT03245619|FG000|Participant Flow|Part A: Placebo|Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
11316498|NCT03245619|FG001|Participant Flow|Part A-Cohort 1: GSK3335065 0.1 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
11316499|NCT03245619|FG002|Participant Flow|Part A-Cohort 2: GSK3335065 0.25 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
11316500|NCT03245619|FG003|Participant Flow|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316501|NCT03245619|FG004|Participant Flow|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316502|NCT03245619|FG005|Participant Flow|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316503|NCT03245619|FG006|Participant Flow|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316504|NCT03245619|FG007|Participant Flow|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316505|NCT03245619|FG008|Participant Flow|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316506|NCT03245619|FG009|Participant Flow|Part B: Placebo|Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
11316507|NCT03245619|FG010|Participant Flow|Part B-Cohort 9: 0.14 mg IV Bolus+0.012 mg/Hour IV Infusion|Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.012 mg/hour for 7 days.
11316508|NCT03245619|FG011|Participant Flow|Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
11316509|NCT03245619|FG012|Participant Flow|Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
11316510|NCT03245619|FG013|Participant Flow|Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
11316511|NCT03245619|FG014|Participant Flow|Part C: Placebo|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
11316512|NCT03245619|FG015|Participant Flow|Part C-Cohort 13: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
11316513|NCT03245619|FG016|Participant Flow|Part C-Cohort 14: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
11316514|NCT03245619|OG000|Outcome|Part A: Placebo|Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
11316515|NCT03245619|OG001|Outcome|Part A-Cohort 1: GSK3335065 0.1 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
11316516|NCT03245619|OG002|Outcome|Part A-Cohort 2: GSK3335065 0.25 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
11316517|NCT03245619|OG003|Outcome|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316518|NCT03245619|OG004|Outcome|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316519|NCT03245619|OG005|Outcome|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316520|NCT03245619|OG006|Outcome|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316521|NCT03245619|OG007|Outcome|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316522|NCT03245619|OG008|Outcome|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316523|NCT03245619|OG000|Outcome|Part B: Placebo|Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
11316524|NCT03245619|OG001|Outcome|Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion|Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 0.012 mg/ hour for 7 days.
11316525|NCT03245619|OG002|Outcome|Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
11316526|NCT03245619|OG003|Outcome|Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
11316527|NCT03245619|OG004|Outcome|Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
11316528|NCT03245619|OG000|Outcome|Part C: Placebo|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
11316529|NCT03245619|OG001|Outcome|Part C-Cohort 13: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
11316530|NCT03245619|OG002|Outcome|Part C-Cohort 14: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
11316531|NCT03245619|OG000|Outcome|Part A-Cohort 1: GSK3335065 0.1 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
11316532|NCT03245619|OG001|Outcome|Part A-Cohort 2: GSK3335065 0.25 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
11316533|NCT03245619|OG000|Outcome|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316534|NCT03245619|OG001|Outcome|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316535|NCT03245619|OG002|Outcome|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316536|NCT03245619|OG003|Outcome|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316537|NCT03245619|OG004|Outcome|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316538|NCT03245619|OG005|Outcome|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316539|NCT03245619|OG000|Outcome|Part C-Cohort 13: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
11316540|NCT03245619|OG000|Outcome|Part C-Cohort 14: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
11316541|NCT03245619|OG000|Outcome|Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion|Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 0.012 mg/ hour for 7 days.
11316542|NCT03245619|OG001|Outcome|Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
11316543|NCT03245619|OG002|Outcome|Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
11316544|NCT03245619|OG003|Outcome|Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
11316545|NCT03245619|OG002|Outcome|Part A-Cohort 1: Placebo|Healthy male participants were administered a single IV bolus dose of GSK3335065 matching placebo on Day 1.
11316546|NCT03245619|OG003|Outcome|Part A-Cohort 2: Placebo|Healthy male participants were administered a single IV bolus dose of GSK3335065 matching placebo on Day 1.
11316547|NCT03245619|OG000|Outcome|Part A-Cohort 3: Placebo|Healthy male participants were administered a single IV bolus dose of GSK3335065 matching placebo on Day 1.
11316548|NCT03245619|OG001|Outcome|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316549|NCT03245619|OG002|Outcome|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316550|NCT03245619|OG003|Outcome|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316551|NCT03245619|OG004|Outcome|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316552|NCT03245619|OG005|Outcome|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316553|NCT03245619|OG006|Outcome|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316554|NCT03245619|EG000|Reported Event|Part A: Placebo|Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
11316555|NCT03245619|EG001|Reported Event|Part A-Cohort 1: GSK3335065 0.1 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
11316556|NCT03245619|EG002|Reported Event|Part A-Cohort 2: GSK3335065 0.25 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
11316557|NCT03245619|EG003|Reported Event|Part A-Cohort 3: GSK3335065 1.3 mg|Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
11316558|NCT03245619|EG004|Reported Event|Part A-Cohort 4: GSK335065 2.6 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
11316559|NCT03245619|EG005|Reported Event|Part A-Cohort 5: GSK335065 5.5 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
11316560|NCT03245619|EG006|Reported Event|Part A-Cohort 6: GSK335065 12 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
11316561|NCT03245619|EG007|Reported Event|Part A-Cohort 7: GSK335065 35 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
11316562|NCT03245619|EG008|Reported Event|Part A-Cohort 8: GSK335065 54 mg|Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
11316563|NCT03245619|EG009|Reported Event|Part B: Placebo|Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
11316564|NCT03245619|EG010|Reported Event|Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion|Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 0.012 mg/ hour for 7 days.
11316565|NCT03245619|EG011|Reported Event|Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
11316566|NCT03245619|EG012|Reported Event|Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
11316567|NCT03245619|EG013|Reported Event|Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion|Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
11316568|NCT03245619|EG014|Reported Event|Part C: Placebo|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
11316569|NCT03245619|EG015|Reported Event|Part C-Cohort 13: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
11316570|NCT03245619|EG016|Reported Event|Part C-Cohort 14: GSK3335065|Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
11316571|NCT03245723|BG000|Baseline|Preterm|"Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).~All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316572|NCT03245723|BG001|Baseline|Term - Healthy Controls|"Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316573|NCT03245723|BG002|Baseline|Total|Total of all reporting groups
11316574|NCT03245723|FG000|Participant Flow|Preterm|"Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).~All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316575|NCT03245723|FG001|Participant Flow|Term - Healthy Controls|"Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316576|NCT03245723|OG000|Outcome|Preterm|"Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).~All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316577|NCT03245723|OG001|Outcome|Term - Healthy Controls|"Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316578|NCT03245723|EG000|Reported Event|Preterm|"Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).~All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316579|NCT03245723|EG001|Reported Event|Term - Healthy Controls|"Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.~Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart~Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart"
11316580|NCT03245736|BG000|Baseline|Tisotumab Vedotin|Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.
11316581|NCT03245736|FG000|Participant Flow|Tisotumab Vedotin|Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.
11316582|NCT03245736|OG000|Outcome|Tisotumab Vedotin|Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.
11316583|NCT03245736|EG000|Reported Event|Overall|Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.
11316584|NCT03245762|BG000|Baseline|Intranasal Oxytocin|"Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.~Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning."
11316585|NCT03245762|BG001|Baseline|IN-placebo|"Intervention: 4 IU/day of placebo via nasal spray device each morning.~Placebo: 4 IU/day of placebo administered via nasal spray device each morning"
11316586|NCT03245762|BG002|Baseline|Total|Total of all reporting groups
11316587|NCT03245762|FG000|Participant Flow|Intranasal Oxytocin|"Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.~Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning."
11316588|NCT03245762|FG001|Participant Flow|IN-placebo|"Intervention: 4 IU/day of placebo via nasal spray device each morning.~Placebo: 4 IU/day of placebo administered via nasal spray device each morning"
11316589|NCT03245762|OG000|Outcome|Intranasal Oxytocin|"Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.~Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning."
11316590|NCT03245762|OG001|Outcome|IN-placebo|"Intervention: 4 IU/day of placebo via nasal spray device each morning.~Placebo: 4 IU/day of placebo administered via nasal spray device each morning"
11316591|NCT03245762|EG000|Reported Event|Intranasal Oxytocin|"Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.~Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning."
11316592|NCT03245762|EG001|Reported Event|IN-placebo|"Intervention: 4 IU/day of placebo via nasal spray device each morning.~Placebo: 4 IU/day of placebo administered via nasal spray device each morning"
11316593|NCT03246061|BG000|Baseline|Basivertebral Nerve (BVN) Ablation|"BVN ablation with standard care~Intracept System: BVN ablation"
11316594|NCT03246061|BG001|Baseline|Standard Care Control|Continue standard care
11316595|NCT03246061|BG002|Baseline|Total|Total of all reporting groups
11316596|NCT03246061|FG000|Participant Flow|Basivertebral Nerve (BVN) Ablation|"BVN ablation with non-surgical standard care~Intracept System: BVN ablation"
11316597|NCT03246061|FG001|Participant Flow|Standard Care Control|Continue with non-surgical standard care
11316598|NCT03246061|OG000|Outcome|Basivertebral Never (BVN) Ablation|"BVN ablation with standard care~Intracept System: RF ablation"
11316599|NCT03246061|OG001|Outcome|Standard Care Control|Continue with standard care
11316600|NCT03246061|OG000|Outcome|Basivertebral Nerve (BVN) Ablation|"BVN ablation with non-surgical standard care~Intracept System: BVN ablation"
11316601|NCT03246061|OG001|Outcome|Standard Care Control|Continue with non-surgical standard care
11316602|NCT03246061|EG000|Reported Event|BVN Ablation|"BVN ablation with continued standard care~Intracept System: BVN ablation using radiofrequency energy"
11316603|NCT03246061|EG001|Reported Event|Standard Care Control|"Continue with non-surgical standard care~Standard Care: Non-surgical standard care"
11316604|NCT03246152|BG000|Baseline|Bevacizumab Group|"Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema.~Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly"
11316605|NCT03246152|FG000|Participant Flow|Bevacizumab Group|"Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema.~Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly"
11316606|NCT03246152|OG000|Outcome|Bevacizumab Group|"Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema.~Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly"
11316607|NCT03246152|EG000|Reported Event|Bevacizumab Group|"Monthly intravitreal injection of Bevacizumab for at least 3 consecutive months. This is followed by treat and extend regimen after resolution of macular edema.~Bevacizumab: Repeated intravitreal injections of Bevacizumab monthly"
11316608|NCT03246646|BG000|Baseline|Coaching + VA-CRAFT|The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.
11316609|NCT03246646|BG001|Baseline|Treatment as Usual (TAU) Coaching|"The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an autonomy-supportive style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills."
11316610|NCT03246646|BG002|Baseline|Total|Total of all reporting groups
11316611|NCT03246646|FG000|Participant Flow|Coaching + VA-CRAFT|The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.
11335933|NCT03558997|EG003|Reported Event|Dupilumab + SCIT|Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 to 7 days.
11316612|NCT03246646|FG001|Participant Flow|Treatment as Usual (TAU) Coaching|"The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an autonomy-supportive style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills."
11316613|NCT03246646|OG000|Outcome|Coaching + VA CRAFT|"Telephone coaching along with web-based CRAFT course~Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants"
11316614|NCT03246646|OG001|Outcome|Treatment as Usual|"Treatment as usual matched comparison~Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants"
11316615|NCT03246646|EG000|Reported Event|Coaching + VA CRAFT|"Telephone coaching along with web-based CRAFT course~Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants"
11316616|NCT03246646|EG001|Reported Event|Treatment as Usual|"Treatment as usual matched comparison~Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants"
11316617|NCT03246672|BG000|Baseline|Maintenance|"behavioral intervention to increase adherence to lifestyle recommendations~maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support."
11316618|NCT03246672|FG000|Participant Flow|Maintenance|"behavioral intervention to increase adherence to lifestyle recommendations~maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support."
11316619|NCT03246672|OG000|Outcome|Maintenance|"behavioral intervention to increase adherence to lifestyle recommendations~maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support."
11316620|NCT03246672|EG000|Reported Event|Maintenance|"behavioral intervention to increase adherence to lifestyle recommendations~maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support."
11316621|NCT03246724|BG000|Baseline|Cataract Procedures|"The following ocular procedures will fall under this arm of the study:~• Cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation~Triazolam or microcrystalline cellulose oral placebo: Administered 30 minutes prior to surgery.~Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg~Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg"
11316622|NCT03246724|BG001|Baseline|Retina Procedures|"The following ocular procedures will fall under this arm of the study:~Pars plana vitrectomy~Pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation~Triazolam or microcrystalline cellulose oral placebo: Administered 30 minutes prior to surgery.~Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg~Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg"
11316623|NCT03246724|BG002|Baseline|Cornea Procedures|"The following ocular procedures will fall under this arm of the study:~Descemet Stripping Endothelial Keratoplasty (DSEK)~Cataracts with DSEK~Descemet Membrane Endothelial Keratoplasty(DMEK)~Cataracts with DMEK~Conjunctival and/or corneal lesion excisions~Pterygium~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation~Triazolam or oral placebo: Administered 30 minutes prior to surgery Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg~Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg"
11316624|NCT03246724|BG003|Baseline|Glaucoma Procedures|"The following ocular procedures will fall under this arm of the study:~Ahmed valve~Ahmed valve with cataracts~Trabeculectomy~Trabeculectomy with cataracts~Baerveldt~Baerveldt with cataracts~Endocyclophotocoagulation (ECP)~ECP with cataracts~Istent~Cataracts with istent~Kahook~Cataracts with kahook~Cypass~Cypass with cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% IV placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation~Triazolam or placebo: Given 30 minutes prior to surgery Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg~Midazolam or placebo: Given 5 minutes prior to surgery Dose for BMI less than 35: 1."
11316625|NCT03246724|BG004|Baseline|Total|Total of all reporting groups
11316626|NCT03246724|FG000|Participant Flow|Cataract Procedures|"The following ocular procedures will fall under this arm of the study:~• Cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316627|NCT03246724|FG001|Participant Flow|Retina Procedures|"The following ocular procedures will fall under this arm of the study:~Pars plana vitrectomy (PPV)~PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316628|NCT03246724|FG002|Participant Flow|Cornea Procedures|"The following ocular procedures will fall under this arm of the study:~Descemet Stripping Endothelial Keratoplasty (DSEK)~Cataracts with DSEK~Descemet Membrane Endothelial Keratoplasty (DMEK)~Cataracts with DMEK~Conjunctival and/or corneal lesion excisions~Pterygium~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316629|NCT03246724|FG003|Participant Flow|Glaucoma Procedures|"The following ocular procedures will fall under this arm of the study:~Ahmed valve~Ahmed valve with cataracts~Trabeculectomy~Trabeculectomy with cataracts~Baerveldt~Baerveldt with cataracts~Endocyclophotocoagulation~Endocyclophotocoagulation with cataracts~Istent~Cataracts with istent~Kahook~Cataracts with kahook~Cypass~Cypass with cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316630|NCT03246724|OG000|Outcome|Cataract Procedures|"The following ocular procedures will fall under this arm of the study:~• Cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316631|NCT03246724|OG001|Outcome|Retina Procedures|"The following ocular procedures will fall under this arm of the study:~Pars plana vitrectomy (PPV)~PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316632|NCT03246724|OG002|Outcome|Cornea Procedures|"The following ocular procedures will fall under this arm of the study:~Descemet Stripping Endothelial Keratoplasty (DSEK)~Cataracts with DSEK~Descemet Membrane Endothelial Keratoplasty (DMEK)~Cataracts with DMEK~Conjunctival and/or corneal lesion excisions~Pterygium~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316633|NCT03246724|OG003|Outcome|Glaucoma Procedures|"The following ocular procedures will fall under this arm of the study:~Ahmed valve~Ahmed valve with cataracts~Trabeculectomy~Trabeculectomy with cataracts~Baerveldt~Baerveldt with cataracts~Endocyclophotocoagulation~Endocyclophotocoagulation with cataracts~Istent~Cataracts with istent~Kahook~Cataracts with kahook~Cypass~Cypass with cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316634|NCT03246724|EG000|Reported Event|Cataract Procedures|"The following ocular procedures will fall under this arm of the study:~• Cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316635|NCT03246724|EG001|Reported Event|Retina Procedures|"The following ocular procedures will fall under this arm of the study:~Pars plana vitrectomy (PPV)~PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316636|NCT03246724|EG002|Reported Event|Cornea Procedures|"The following ocular procedures will fall under this arm of the study:~Descemet Stripping Endothelial Keratoplasty (DSEK)~Cataracts with DSEK~Descemet Membrane Endothelial Keratoplasty (DMEK)~Cataracts with DMEK~Conjunctival and/or corneal lesion excisions~Pterygium~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11335934|NCT03559062|BG000|Baseline|Placebo|Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks.
11316637|NCT03246724|EG003|Reported Event|Glaucoma Procedures|"The following ocular procedures will fall under this arm of the study:~Ahmed valve~Ahmed valve with cataracts~Trabeculectomy~Trabeculectomy with cataracts~Baerveldt~Baerveldt with cataracts~Endocyclophotocoagulation~Endocyclophotocoagulation with cataracts~Istent~Cataracts with istent~Kahook~Cataracts with kahook~Cypass~Cypass with cataracts~Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:~Triazolam oral sedation with sodium chloride 0.9% intravenous placebo~Microcrystalline cellulose oral placebo with midazolam intravenous sedation"
11316638|NCT03247322|BG000|Baseline|Intervention Group|"Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).~Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable)."
11316639|NCT03247322|BG001|Baseline|Control Group|Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
11316640|NCT03247322|BG002|Baseline|Total|Total of all reporting groups
11316641|NCT03247322|FG000|Participant Flow|mHealth Group|"Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).~Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable)."
11095148|NCT01556581|FG001|Participant Flow|Early Physical Therapy (PT)|"All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.~Early Physical Therapy (PT): Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms)."
11095149|NCT01556581|OG000|Outcome|Usual Care (UC)|"The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.~Usual Care (UC): Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress."
11095150|NCT01556581|OG001|Outcome|Early Physical Therapy (PT)|"All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.~Early Physical Therapy (PT): Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms)."
11095151|NCT01556581|EG000|Reported Event|Usual Care (UC)|"The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.~Usual Care (UC): Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress."
11095152|NCT01556581|EG001|Reported Event|Early Physical Therapy (PT)|"All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.~Early Physical Therapy (PT): Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms)."
11095153|NCT01556594|BG000|Baseline|Treatment Group 1|NG dose of 1 mg and 2 mg. SC glucagon dose of 1mg.
11095154|NCT01556594|BG001|Baseline|Treatment Group 2|NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.
11095155|NCT01556594|BG002|Baseline|Treatment Group 3|NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.
11095156|NCT01556594|BG003|Baseline|Total|Total of all reporting groups
11095157|NCT01556594|FG000|Participant Flow|Treatment Group 1|Nasal glucagon (NG) dose of 1 milligram (mg) and 2 mg. Subcutaneous (SC) glucagon dose of 1mg.
11095158|NCT01556594|FG001|Participant Flow|Treatment Group 2|NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.
11095159|NCT01556594|FG002|Participant Flow|Treatment Group 3|NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.
11095160|NCT01556594|OG000|Outcome|SC Glucagon|SC glucagon injection 1 mg
11095161|NCT01556594|OG001|Outcome|NG 1 mg|NG dose of 1 mg
10827508|NCT00110266|FG000|Participant Flow|Deferasirox|Participants received Deferasirox 20 Milligrams per Kilogram per day (mg/kg/day) orally once per day (OD) for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10827509|NCT00110266|OG000|Outcome|Deferasirox|Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10827510|NCT00110266|EG000|Reported Event|Deferasirox|Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10827511|NCT00110266|EG001|Reported Event|Enrolled, Not Treated|Participant died before initiating the treatment.
10827512|NCT00110305|BG000|Baseline|TMC278 25 mg|TMC278 25 mg once daily
10827513|NCT00110305|BG001|Baseline|TMC278 75 mg|TMC278 75 mg once daily
10827514|NCT00110305|BG002|Baseline|TMC 150 mg|TMC278 150 mg once daily
10827515|NCT00110305|BG003|Baseline|Efavirenz|Efavirenz 600 mg once daily
10827516|NCT00110305|BG004|Baseline|Total|Total of all reporting groups
10827517|NCT00110305|FG000|Participant Flow|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
10827518|NCT00110305|FG001|Participant Flow|Efavirenz|Efavirenz 600 mg once daily
10827519|NCT00110305|OG000|Outcome|TMC278 25 mg|TMC278 25 mg once daily
10827520|NCT00110305|OG001|Outcome|TMC278 75 mg|TMC278 75 mg once daily
10827521|NCT00110305|OG002|Outcome|TMC278 150 mg|TMC278 150 mg once daily
10827522|NCT00110305|OG003|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
10827523|NCT00110305|OG004|Outcome|Efavirenz|Efaviren 600 mg once daily
11095162|NCT01556594|OG002|Outcome|NG 2 mg|NG dose of 2 mg
10827524|NCT00110305|OG004|Outcome|Efavirenz|Efavirenz 600 mg once daily
10827525|NCT00110305|OG000|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
10827526|NCT00110305|OG001|Outcome|Efavirenz|Efavirenz 600 mg once daily
10827527|NCT00110305|OG000|Outcome|TMC278 25mg|TMC278 25 mg once daily
10827528|NCT00110305|OG000|Outcome|AUC24h Quartile 1|TMC278 25 mg, 75 mg, and 150 mg once daily
10827529|NCT00110305|OG001|Outcome|AUC24h Quartile 2|TMC278 25 mg, 75 mg, and 150 mg once daily
10827530|NCT00110305|OG002|Outcome|AUC24h Quartile 3|TMC278 25 mg, 75 mg, and 150 mg once daily
10827531|NCT00110305|OG003|Outcome|AUC24h Quartile 4|TMC278 25 mg, 75 mg, and 150 mg once daily
10827532|NCT00110305|EG000|Reported Event|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
10827533|NCT00110305|EG001|Reported Event|Efavirenz|Efavirenz 600 mg once daily
10827534|NCT00110357|BG000|Baseline|1- to 12-years-old|
10827535|NCT00110357|BG001|Baseline|13- to 18-years-old|
10827536|NCT00110357|BG002|Baseline|Total|Total of all reporting groups
10827537|NCT00110357|FG000|Participant Flow|1- to 12-years-old|
10827538|NCT00110357|FG001|Participant Flow|13- to 18-years-old|
10827539|NCT00110357|OG000|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
10827540|NCT00110357|OG001|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
10827541|NCT00110357|OG002|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
10827542|NCT00110357|OG003|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
10827543|NCT00110357|OG004|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
10827544|NCT00110357|OG005|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
10827545|NCT00110357|OG006|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
10827546|NCT00110357|OG000|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
10827547|NCT00110357|OG001|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
10827548|NCT00110357|OG002|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
10827549|NCT00110357|OG003|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
10827550|NCT00110357|OG004|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
10827551|NCT00110357|OG005|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
10827552|NCT00110357|OG001|Outcome|Group A: 150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
10827553|NCT00110357|OG000|Outcome|CNS Primary Tumor|
10827554|NCT00110357|OG001|Outcome|Non-CNS Primary Tumor|
10827555|NCT00110357|OG000|Outcome|Number of Participants|
10827556|NCT00110357|OG000|Outcome|Group A (Ages 1-12 Years)|
10827557|NCT00110357|OG001|Outcome|Group B (Ages 13-18 Years)|
10827558|NCT00110357|OG000|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
10827559|NCT00110357|OG001|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
10827560|NCT00110357|OG002|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
10827561|NCT00110357|OG003|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
10827562|NCT00110357|OG004|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
10827563|NCT00110357|OG005|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
11095163|NCT01556594|OG003|Outcome|NG 3 mg|NG dose of 3 mg
11095164|NCT01556594|EG000|Reported Event|SC Glucagon|SC glucagon injection 1 mg
11095165|NCT01556594|EG001|Reported Event|NG 1 mg|NG dose of 1 mg
11316642|NCT03247322|FG001|Participant Flow|Usual Care Group|Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
11316643|NCT03247322|OG000|Outcome|Intervention Group|"Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).~Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable)."
11316644|NCT03247322|OG001|Outcome|Control Group|Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
11316645|NCT03247322|OG000|Outcome|mHealth Group|"Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).~Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable)."
11316646|NCT03247322|OG001|Outcome|Usual Care Group|Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
11316647|NCT03247322|EG000|Reported Event|Intervention Group|"Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).~Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable)."
11316648|NCT03247322|EG001|Reported Event|Control Group|Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
11316649|NCT03247517|BG000|Baseline|Placebo|"Placebo oral capsule~Treatment A: Placebo will be administered once daily"
11316650|NCT03247517|BG001|Baseline|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: SPN-812 will be administered once daily and compared to placebo"
11316651|NCT03247517|BG002|Baseline|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: SPN-812 will be administered once daily and compared to placebo"
11316652|NCT03247517|BG003|Baseline|Total|Total of all reporting groups
11316653|NCT03247517|FG000|Participant Flow|Placebo|"Placebo oral capsule~Treatment A: Placebo will be administered once daily"
11316654|NCT03247517|FG001|Participant Flow|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to placebo"
11316655|NCT03247517|FG002|Participant Flow|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to placebo"
11316656|NCT03247517|OG000|Outcome|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316657|NCT03247517|OG001|Outcome|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to placebo"
11316658|NCT03247517|OG002|Outcome|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to placebo"
11316659|NCT03247517|EG000|Reported Event|Placebo|"Placebo oral capsule~Treatment A: Placebo will be administered once daily"
11316660|NCT03247517|EG001|Reported Event|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to placebo"
11316661|NCT03247517|EG002|Reported Event|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to placebo"
11316662|NCT03247530|BG000|Baseline|Placebo|"Placebo oral capsule~Treatment A: Placebo oral capsule was administered once daily"
11316663|NCT03247530|BG001|Baseline|100mg SPN-812|"SPN-812 oral capsule~Treatment B: 100mg SPN-812 was administered once daily and compared to placebo"
11316664|NCT03247530|BG002|Baseline|200mg SPN-812|"SPN-812 oral capsule~Treatment C: 200mg SPN-812 was administered once daily and compared to placebo"
11316665|NCT03247530|BG003|Baseline|Total|Total of all reporting groups
11316666|NCT03247530|FG000|Participant Flow|Placebo|"Placebo oral capsule~Treatment A: Placebo oral capsule was administered once daily"
11316667|NCT03247530|FG001|Participant Flow|100mg SPN-812|"SPN-812 oral capsule~Treatment B: 100mg SPN-812 was administered once daily and compared to placebo"
11316668|NCT03247530|FG002|Participant Flow|200mg SPN-812|"SPN-812 oral capsule~Treatment C: 200mg SPN-812 was administered once daily and compared to placebo"
11316669|NCT03247530|OG000|Outcome|Placebo|"Placebo, oral capsule~Treatment A: Placebo was administered once daily"
11316670|NCT03247530|OG001|Outcome|100mg SPN-812|"SPN-812 oral capsule~Treatment B: 100mg SPN-812 was administered once daily and compared to placebo"
11316671|NCT03247530|OG002|Outcome|200mg SPN-812|"SPN-812 oral capsule~Treatment C: 200mg SPN-812 was administered once daily and compared to placebo"
11316672|NCT03247530|OG002|Outcome|200mg SPN-812|"SPN-812, oral capsule~Treatment C: 200mg SPN-812 was administered once daily and compared to placebo"
11316673|NCT03247530|OG000|Outcome|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11095166|NCT01556594|EG002|Reported Event|NG 2 mg|NG dose of 2 mg
11095167|NCT01556594|EG003|Reported Event|NG 3 mg|NG dose of 3 mg
11316674|NCT03247530|OG000|Outcome|Placebo|"Placebo oral capsule~Treatment A: Placebo oral capsule was administered once daily"
11316675|NCT03247530|EG000|Reported Event|Placebo|"Placebo oral capsule~Treatment A: Placebo administered once daily"
11316676|NCT03247530|EG001|Reported Event|100mg SPN-812|"SPN-812 oral capsule~Treatment B: 100mg SPN-812 administered once daily and compared to placebo"
11316677|NCT03247530|EG002|Reported Event|200mg SPN-812|"SPN-812 oral capsule~Treatment C: 200mg SPN-812 administered once daily and compared to placebo"
11316678|NCT03247543|BG000|Baseline|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316679|NCT03247543|BG001|Baseline|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: 200mg SPN-812 was administered once daily"
11316680|NCT03247543|BG002|Baseline|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: 400mg SPN-812 was administered once daily"
11316681|NCT03247543|BG003|Baseline|Total|Total of all reporting groups
11316682|NCT03247543|FG000|Participant Flow|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316683|NCT03247543|FG001|Participant Flow|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: 200mg SPN-812 was administered once daily"
11316684|NCT03247543|FG002|Participant Flow|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: 400mg SPN-812 was administered once daily"
11316685|NCT03247543|OG000|Outcome|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316686|NCT03247543|OG001|Outcome|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: 200mg SPN-812 was administered once daily and compared to placebo"
11316687|NCT03247543|OG002|Outcome|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: 400mg SPN-812 was administered once daily and compared to placebo"
11316688|NCT03247543|OG001|Outcome|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: 200mg SPN-812 was administered once daily"
11316689|NCT03247543|OG002|Outcome|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: 400mg SPN-812 was administered once daily"
11316690|NCT03247543|EG000|Reported Event|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316691|NCT03247543|EG001|Reported Event|200mg SPN-812|"200mg SPN-812 oral capsule~Treatment B: 200mg SPN-812 was administered once daily"
11316692|NCT03247543|EG002|Reported Event|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment C: 400mg SPN-812 was administered once daily"
11316693|NCT03247556|BG000|Baseline|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316694|NCT03247556|BG001|Baseline|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to Placebo"
11316695|NCT03247556|BG002|Baseline|600mg SPN-812|"600mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to Placebo"
11316696|NCT03247556|BG003|Baseline|Total|Total of all reporting groups
11316697|NCT03247556|FG000|Participant Flow|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316698|NCT03247556|FG001|Participant Flow|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to Placebo"
11316699|NCT03247556|FG002|Participant Flow|600mg SPN-812|"600mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to Placebo"
11316700|NCT03247556|OG000|Outcome|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316701|NCT03247556|OG001|Outcome|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to Placebo"
11316702|NCT03247556|OG002|Outcome|600mg SPN-812|"600mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to Placebo"
11316703|NCT03247556|EG000|Reported Event|Placebo|"Placebo oral capsule~Treatment A: Placebo was administered once daily"
11316704|NCT03247556|EG001|Reported Event|400mg SPN-812|"400mg SPN-812 oral capsule~Treatment B: SPN-812 was administered once daily and compared to Placebo"
11316705|NCT03247556|EG002|Reported Event|600mg SPN-812|"600mg SPN-812 oral capsule~Treatment C: SPN-812 was administered once daily and compared to Placebo"
11316706|NCT03247673|BG000|Baseline|CT-P16|"CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects~CT-P16: CT-P16 is a biosimilar product for Avastin"
11316707|NCT03247673|BG001|Baseline|EU-approved Avastin|"EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~EU-approved Avastin: EU-approved Avastin"
11316708|NCT03247673|BG002|Baseline|US-licensed Avastin|"US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~US-licensed Avastin: US-licensed Avastin"
11316709|NCT03247673|BG003|Baseline|Total|Total of all reporting groups
11316710|NCT03247673|FG000|Participant Flow|CT-P16|"CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects~CT-P16: CT-P16 is a biosimilar product for Avastin"
11316711|NCT03247673|FG001|Participant Flow|EU-approved Avastin|"EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~EU-approved Avastin: EU-approved Avastin"
11316712|NCT03247673|FG002|Participant Flow|US-licensed Avastin|"US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~US-licensed Avastin: US-licensed Avastin"
11316713|NCT03247673|OG000|Outcome|CT-P16|"CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects~CT-P16: CT-P16 is a biosimilar product for Avastin"
11316714|NCT03247673|OG001|Outcome|EU-approved Avastin|"EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~EU-approved Avastin: EU-approved Avastin"
11316715|NCT03247673|OG002|Outcome|US-licensed Avastin|"US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~US-licensed Avastin: US-licensed Avastin"
11316716|NCT03247673|EG000|Reported Event|CT-P16|"CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects~CT-P16: CT-P16 is a biosimilar product for Avastin"
11316717|NCT03247673|EG001|Reported Event|EU-approved Avastin|"EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~EU-approved Avastin: EU-approved Avastin"
11316718|NCT03247673|EG002|Reported Event|US-licensed Avastin|"US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects~US-licensed Avastin: US-licensed Avastin"
10827564|NCT00110357|OG006|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
10827565|NCT00110357|EG000|Reported Event|01 75 mg/m2 CET + 20 mg/m2 IRI|
10827566|NCT00110357|EG001|Reported Event|02 150 mg/m2 CET + 20 mg/m2 IRI|
10827567|NCT00110357|EG002|Reported Event|03 150 mg/m2 CET + 16 mg/m2 IRI|
10827568|NCT00110357|EG003|Reported Event|04 250 mg/m2 CET + 16 mg/m2 IRI|
10827569|NCT00110357|EG004|Reported Event|05 250 mg/m2 CET + 20 mg/m2 IRI|
10827570|NCT00110396|BG000|Baseline|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
10827571|NCT00110396|FG000|Participant Flow|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
10827572|NCT00110396|OG000|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
10827573|NCT00110396|EG000|Reported Event|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
10827574|NCT00110461|BG000|Baseline|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
10827575|NCT00110461|BG001|Baseline|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
10827576|NCT00110461|BG002|Baseline|Placebo|Participants were given a single pill administered once daily.
10827577|NCT00110461|BG003|Baseline|Total|Total of all reporting groups
10827578|NCT00110461|FG000|Participant Flow|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
10827579|NCT00110461|FG001|Participant Flow|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
10827580|NCT00110461|FG002|Participant Flow|Placebo|Participants were given a single pill administered once daily.
11095168|NCT01556633|BG000|Baseline|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
10827581|NCT00110461|OG000|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
10827582|NCT00110461|OG001|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
10827583|NCT00110461|OG002|Outcome|Placebo|Participants were given a single pill administered once daily.
10827584|NCT00110461|EG000|Reported Event|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
10827585|NCT00110461|EG001|Reported Event|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
10827586|NCT00110461|EG002|Reported Event|Placebo|Participants were given a single pill administered once daily.
10827587|NCT00110513|BG000|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
10827588|NCT00110513|FG000|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
10827589|NCT00110513|OG000|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
10827590|NCT00110513|EG000|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
10827591|NCT00110617|BG000|Baseline|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
11316719|NCT03247686|BG000|Baseline|Placebo|"Placebo~Placebo: Placebo"
11316720|NCT03247686|BG001|Baseline|RSLV-132|"Experimental drug~RSLV-132: RNase Fc fusion protein"
11316721|NCT03247686|BG002|Baseline|Total|Total of all reporting groups
11316722|NCT03247686|FG000|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
11316723|NCT03247686|FG001|Participant Flow|RSLV-132|"Experimental drug~RSLV-132: RNase Fc fusion protein"
11316724|NCT03247686|OG000|Outcome|Placebo|"Placebo~Placebo: Placebo"
11316725|NCT03247686|OG001|Outcome|RSLV-132 All|"Experimental drug~RSLV-132: RNase Fc fusion protein~All participants receiving RSLV-132"
11316726|NCT03247686|OG002|Outcome|RSLV-132 Responders|"Experimental drug~RSLV-132: RNase Fc fusion protein~Participants receiving RSLV-132 showing a clinically meaningful improvement in two of the three patient reported outcomes"
11316727|NCT03247686|OG003|Outcome|RSLV-132 Non-responders|"Experimental drug~RSLV-132: RNase Fc fusion protein~Participants receiving RSLV-132 not showing a clinically meaningful improvement in two of the three patient reported outcomes"
11316728|NCT03247686|OG001|Outcome|RSLV-132|"Experimental drug~RSLV-132: RNase Fc fusion protein"
11316729|NCT03247686|EG000|Reported Event|Placebo|"Placebo~Placebo: Placebo"
11316730|NCT03247686|EG001|Reported Event|RSLV-132|"Experimental drug~RSLV-132: RNase Fc fusion protein"
11316731|NCT03247738|BG000|Baseline|Cangrelor|"Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours~Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316732|NCT03247738|BG001|Baseline|Placebo|"Normal saline bolus and infusion for 2 hours~Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316733|NCT03247738|BG002|Baseline|Total|Total of all reporting groups
11316734|NCT03247738|FG000|Participant Flow|Cangrelor|"Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours~Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316735|NCT03247738|FG001|Participant Flow|Placebo|"Normal saline bolus and infusion for 2 hours~Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316736|NCT03247738|OG000|Outcome|Cangrelor|"Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours~Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316737|NCT03247738|OG001|Outcome|Placebo|"Normal saline bolus and infusion for 2 hours~Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316738|NCT03247738|EG000|Reported Event|Cangrelor|"Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours~Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316739|NCT03247738|EG001|Reported Event|Placebo|"Normal saline bolus and infusion for 2 hours~Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h."
11316740|NCT03247790|BG000|Baseline|Lasmiditan|Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2).
11316741|NCT03247790|FG000|Participant Flow|Lasmiditan|Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2).
11316742|NCT03247790|OG000|Outcome|Lasmiditan (Period 1)|Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
11316743|NCT03247790|OG001|Outcome|Lasmiditan (Period 2)|Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during during inter-ictal period.
11316744|NCT03247790|EG000|Reported Event|Lasmiditan (Period 1)|Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
11316745|NCT03247790|EG001|Reported Event|Lasmiditan (Period 2)|Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during inter-ictal period.
11316746|NCT03247816|BG000|Baseline|Number of Eligible Subjects|Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
11316747|NCT03247816|FG000|Participant Flow|Number of Eligible Subjects|Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
11316748|NCT03247816|OG000|Outcome|Normalised Hb at 12 Weeks|Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
11316749|NCT03247816|OG001|Outcome|Not Normalised Hb at 12 Weeks|Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
11316750|NCT03247816|OG000|Outcome|Number of Eligible Subjects|Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
11316751|NCT03247816|EG000|Reported Event|Number of Eligible Subjects|Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
11316752|NCT03247985|BG000|Baseline|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
11335935|NCT03559062|BG001|Baseline|TEZ/IVA|Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
11316753|NCT03247985|BG001|Baseline|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation"
11316754|NCT03247985|BG002|Baseline|Total|Total of all reporting groups
11316755|NCT03247985|FG000|Participant Flow|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
11316756|NCT03247985|FG001|Participant Flow|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation"
11316757|NCT03247985|OG000|Outcome|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
11316758|NCT03247985|OG001|Outcome|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation"
11316759|NCT03247985|EG000|Reported Event|PROLENE Polypropylene Tacking Mesh|"Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.~PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks"
11316760|NCT03247985|EG001|Reported Event|ProGrip Self-fixating Mesh|"Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery~ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation"
11316761|NCT03248037|BG000|Baseline|Netarsudil|"Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months~Netarsudil: netarsudil opthalmic solution 0.02%"
11316762|NCT03248037|BG001|Baseline|Placebo|"Placebo eye drop, dosed topically once a day for 9 months~Placebo: Placebo eye drops"
11316763|NCT03248037|BG002|Baseline|Total|Total of all reporting groups
11316764|NCT03248037|FG000|Participant Flow|Netarsudil|"Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months~Netarsudil: netarsudil opthalmic solution 0.02%"
11316765|NCT03248037|FG001|Participant Flow|Placebo|"Placebo eye drop, dosed topically once a day for 9 months~Placebo: Placebo eye drops"
11316766|NCT03248037|OG000|Outcome|Netarsudil|"Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months~Netarsudil: netarsudil opthalmic solution 0.02%"
11316767|NCT03248037|OG001|Outcome|Placebo|"Placebo eye drop, dosed topically once a day for 9 months~Placebo: Placebo eye drops"
11316768|NCT03248037|EG000|Reported Event|Netarsudil|"Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months~Netarsudil: netarsudil opthalmic solution 0.02%"
11316769|NCT03248037|EG001|Reported Event|Placebo|"Placebo eye drop, dosed topically once a day for 9 months~Placebo: Placebo eye drops"
11316770|NCT03248440|BG000|Baseline|Placebo TDS|Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316771|NCT03248440|BG001|Baseline|SUN-131 1.5% TDS|SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316772|NCT03248440|BG002|Baseline|Total|Total of all reporting groups
11316773|NCT03248440|FG000|Participant Flow|Placebo TDS|Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316774|NCT03248440|FG001|Participant Flow|SUN-131 1.5% TDS|SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316775|NCT03248440|OG000|Outcome|Placebo TDS|Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316776|NCT03248440|OG001|Outcome|SUN-131 1.5% TDS|SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316777|NCT03248440|EG000|Reported Event|Placebo TDS|Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316778|NCT03248440|EG001|Reported Event|SUN-131 1.5% TDS|SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
11316779|NCT03248492|BG000|Baseline|Part 1: DS-8201a Low Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316780|NCT03248492|BG001|Baseline|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316781|NCT03248492|BG002|Baseline|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316782|NCT03248492|BG003|Baseline|Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
11316783|NCT03248492|BG004|Baseline|Part 2b (Exploratory): DS-8201a Low Dose|All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
11316784|NCT03248492|BG005|Baseline|Total|Total of all reporting groups
11316785|NCT03248492|FG000|Participant Flow|Part 1: DS-8201a Low Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316786|NCT03248492|FG001|Participant Flow|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316787|NCT03248492|FG002|Participant Flow|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase.
11316788|NCT03248492|FG003|Participant Flow|Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
11316789|NCT03248492|FG004|Participant Flow|Part 2b (Exploratory): DS-8201a Low Dose|All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
11316790|NCT03248492|OG000|Outcome|Part 1 and Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
11316791|NCT03248492|OG001|Outcome|Part 1 + Part 2a + Part 2b: DS-8201a Low Dose|All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
11316792|NCT03248492|OG002|Outcome|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316793|NCT03248492|OG003|Outcome|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11095169|NCT01556633|BG001|Baseline|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
11316794|NCT03248492|OG000|Outcome|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316795|NCT03248492|OG001|Outcome|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316796|NCT03248492|OG002|Outcome|Part 1 + Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
11316797|NCT03248492|OG003|Outcome|Part 1 + Part 2a + Part 2b: DS-8201a Low Dose|All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
11316798|NCT03248492|OG000|Outcome|Part 1: DS-8201a Low Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316799|NCT03248492|OG001|Outcome|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316800|NCT03248492|OG002|Outcome|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316801|NCT03248492|OG003|Outcome|Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.
11316802|NCT03248492|OG004|Outcome|Part 2b (Exploratory): DS-8201a Low Dose|All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
11316803|NCT03248492|EG000|Reported Event|Part 1: DS-8201a Low Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316804|NCT03248492|EG001|Reported Event|Part 1: DS-8201a Medium Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316805|NCT03248492|EG002|Reported Event|Part 1: DS-8201a High Dose|T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
11316806|NCT03248492|EG003|Reported Event|Part 2a: DS-8201a Low Dose|All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
11316807|NCT03248492|EG004|Reported Event|Part 2b (Exploratory): DS-8201a Low Dose|All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.
11095170|NCT01556633|BG002|Baseline|Total|Total of all reporting groups
11316808|NCT03248882|BG000|Baseline|Placebo|Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
11316809|NCT03248882|BG001|Baseline|PF-05221304 2 mg|PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
11316810|NCT03248882|BG002|Baseline|PF-05221304 10 mg|PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
11316811|NCT03248882|BG003|Baseline|PF-05221304 25 mg|PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
11316812|NCT03248882|BG004|Baseline|PF-05221304 50 mg|PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
11316813|NCT03248882|BG005|Baseline|Total|Total of all reporting groups
11316814|NCT03248882|FG000|Participant Flow|Placebo|Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
11316815|NCT03248882|FG001|Participant Flow|PF-05221304 2 mg|PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
11316816|NCT03248882|FG002|Participant Flow|PF-05221304 10 mg|PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
11316817|NCT03248882|FG003|Participant Flow|PF-05221304 25 mg|PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
11316818|NCT03248882|FG004|Participant Flow|PF-05221304 50 mg|PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
11316819|NCT03248882|OG000|Outcome|Placebo|Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
11316820|NCT03248882|OG001|Outcome|PF-05221304 2 mg|PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
11316821|NCT03248882|OG002|Outcome|PF-05221304 10 mg|PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
11316822|NCT03248882|OG003|Outcome|PF-05221304 25 mg|PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
11316823|NCT03248882|OG004|Outcome|PF-05221304 50 mg|PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
11316824|NCT03248882|EG000|Reported Event|Placebo|Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
11316825|NCT03248882|EG001|Reported Event|PF-05221304 2 mg|PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
11316826|NCT03248882|EG002|Reported Event|PF-05221304 10 mg|PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
11316827|NCT03248882|EG003|Reported Event|PF-05221304 25 mg|PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
11316828|NCT03248882|EG004|Reported Event|PF-05221304 50 mg|PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
11316829|NCT03248947|BG000|Baseline|Pharmacist-administered Buprenorphine Maintenance Care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
11316830|NCT03248947|FG000|Participant Flow|Pharmacist-administered Buprenorphine Maintenance Care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
11316831|NCT03248947|OG000|Outcome|Pre-screened Participants|Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation.
11316832|NCT03248947|OG001|Outcome|Consented Participants|Participants who signed the study informed consent form and then underwent screening to determine study eligibility.
11316833|NCT03248947|OG000|Outcome|Pharmacist-administered Buprenorphine Maintenance Care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
11316834|NCT03248947|OG001|Outcome|Study Physicians and Pharmacists|Comprised of the physicians (n=6) and pharmacists (n=6) who participated in the study.
11316835|NCT03248947|OG000|Outcome|Pharmacist-administered Buprenorphine Maintenance Care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription from the physician.
11316836|NCT03248947|EG000|Reported Event|Pharmacist-administered Buprenorphine Maintenance Care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
11316837|NCT03249116|BG000|Baseline|Control - Interaction With a Stuffed Dog|Active control - interaction with a stuffed dog
11316838|NCT03249116|BG001|Baseline|Therapy Dog - Social|"animal-assisted intervention - social interaction only with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316839|NCT03249116|BG002|Baseline|Therapy Dog - Social + Physical|"animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316840|NCT03249116|BG003|Baseline|Total|Total of all reporting groups
11316841|NCT03249116|FG000|Participant Flow|Control|Active control - interaction with a stuffed dog only
11316842|NCT03249116|FG001|Participant Flow|Therapy Dog - Social|"animal-assisted intervention - social interaction only with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316843|NCT03249116|FG002|Participant Flow|Therapy Dog - Social + Physical|"animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316844|NCT03249116|OG000|Outcome|Control - Stuffed Dog|active control: Interaction with a stuffed dog
11316845|NCT03249116|OG001|Outcome|Therapy Dog - Social|"animal-assisted intervention - social interaction only with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316846|NCT03249116|OG002|Outcome|Therapy Dog - Social + Physical|"animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316847|NCT03249116|OG000|Outcome|Control - Stuffed Dog|Active control - interaction with a stuffed dog
11316848|NCT03249116|EG000|Reported Event|Control|"Active control - interaction with a therapy dog~active control: Interaction with a stuffed dog"
11316849|NCT03249116|EG001|Reported Event|Therapy Dog - Social|"animal-assisted intervention - social interaction only with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11335936|NCT03559062|BG002|Baseline|Ivacaftor|Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks.
11335937|NCT03559062|BG003|Baseline|Total|Total of all reporting groups
11335938|NCT03559062|FG000|Participant Flow|Placebo|Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks.
11095171|NCT01556633|FG000|Participant Flow|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
11095172|NCT01556633|FG001|Participant Flow|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
11316850|NCT03249116|EG002|Reported Event|Therapy Dog - Social + Physical|"animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.~animal-assisted intervention: Interaction with a therapy dog"
11316851|NCT03249272|BG000|Baseline|Hypertrophic Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316852|NCT03249272|BG001|Baseline|Non-ischemic Dilated Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of non-ischemic dilated cardiomyopathy patients with MVD by the total number of patients with non-ischemic dilated cardiomyopathy."
11316853|NCT03249272|BG002|Baseline|Control Patients|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of control patients with MVD by the total number of control patients."
11316854|NCT03249272|BG003|Baseline|Total|Total of all reporting groups
11316855|NCT03249272|FG000|Participant Flow|Hypertrophic Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~For the analysis of the global perfusion ratio, the regadenson and adenosine groups were combined.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316856|NCT03249272|FG001|Participant Flow|Non-ischemic Dilated Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~For the analysis of the global perfusion ratio, the regadenson and adenosine groups were combined.~The prevalence will be calculated by dividing the number of non-ischemic dilated cardiomyopathy patients with MVD by the total number of patients with non-ischemic dilated cardiomyopathy."
11316857|NCT03249272|FG002|Participant Flow|Control|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~For the analysis of the global perfusion ratio, the regadenson and adenosine groups were combined.~The prevalence will be calculated by dividing the number of control patients with MVD by the total number of control patients."
11316858|NCT03249272|OG000|Outcome|Hypertrophic Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316859|NCT03249272|OG001|Outcome|Non-ischemic Dilated Cardiomyopathy|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of non-ischemic dilated cardiomyopathy patients with MVD by the total number of patients with non-ischemic dilated cardiomyopathy."
11316860|NCT03249272|OG002|Outcome|Control|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of control patients with MVD by the total number of control patients."
11316861|NCT03249272|OG000|Outcome|Hypertrophic Cardiomyopathy|Global perfusion reserve
11316862|NCT03249272|OG001|Outcome|Non-ischemic Dilated Cardiomyopathy|Global perfusion reserve
10827592|NCT00110617|BG001|Baseline|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
11316863|NCT03249272|OG002|Outcome|Control|Global perfusion reserve
11316864|NCT03249272|OG000|Outcome|Hypertrophic Cardiomyopathy - Scarring|Mean value of all patients with Hypertrophic cardiomyopathy with scarring.
11316865|NCT03249272|OG001|Outcome|Hypertrophic Cardiomyopathy - Without Scarring|Mean value of all patients with Hypertrophic cardiomyopathy without scarring.
11316866|NCT03249272|OG002|Outcome|Non-ischemic Dilated Cardiomyopathy - Scarring|Mean value of all patients with Non-ischemic Dilated cardiomyopathy with scarring.
11316867|NCT03249272|OG003|Outcome|Non-ischemic Dilated Cardiomyopathy - Without Scarring|Mean value of all patients with Non-ischemic Dilated cardiomyopathy without scarring.
11316868|NCT03249272|OG004|Outcome|Control - Scarring|Mean value of all control patients with scarring.
11316869|NCT03249272|OG005|Outcome|Control - Without Scarring|Mean value of all control patients without scarring.
11316870|NCT03249272|EG000|Reported Event|Hypertrophic Cardiomyopathy - Adenosine|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316871|NCT03249272|EG001|Reported Event|Hypertrophic Cardiomyopathy - Regadenoson|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316872|NCT03249272|EG002|Reported Event|Non-ischemic Dilated Cardiomyopathy - Adenosine|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of non-ischemic dilated cardiomyopathy patients with MVD by the total number of patients with non-ischemic dilated cardiomyopathy."
11316873|NCT03249272|EG003|Reported Event|Non-ischemic Dilated Cardiomyopathy - Regadenoson|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316874|NCT03249272|EG004|Reported Event|Control - Adenosine|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of control patients with MVD by the total number of control patients."
11316875|NCT03249272|EG005|Reported Event|Control - Regadenoson|"Microvascular dysfunction (MVD) will be categorized as present based upon the presence of one of the following:~Global perfusion reserve (GPR) < 2.0.~Coronary sinus blood flow (CS) with velocity-encoded CMR will be measured during maximal vasodilation and at rest. GPR was calculated as the ratio of stress CS to rest CS blood flow.~The presence of regional perfusion abnormalities on visual assessment of first pass perfusion images.~The prevalence will be calculated by dividing the number of hypertrophic cardiomyopathy patients with MVD by the total number of patients with hypertrophic cardiomyopathy."
11316876|NCT03249454|BG000|Baseline|All Participants|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316877|NCT03249454|FG000|Participant Flow|Anode, Then Cathode, Then Anode, Then Sham, Then Cathode tsDCS|5 transcutaneous spinal direct current stimulation (tsDCS) sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316878|NCT03249454|FG001|Participant Flow|Sham, Then Cathode, Then Anode, Then Anode, Then Cathode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316879|NCT03249454|FG002|Participant Flow|Anode, Then Cathode, Then Sham, Then Anode, Then Cathode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316880|NCT03249454|FG003|Participant Flow|Cathode, Then Anode, Then Cathode, Then Anode, Then Sham tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316881|NCT03249454|FG004|Participant Flow|Anode, Then Anode, Then Sham, Then Cathode, Then Cathode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11095173|NCT01556633|OG000|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
11316882|NCT03249454|FG005|Participant Flow|Sham, Then Anode, Then Cathode, Then Cathode, Then Anode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316883|NCT03249454|FG006|Participant Flow|Cathode, Then Anode, Then Cathode, Then Sham, Then Anode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316884|NCT03249454|FG007|Participant Flow|Sham, Then Anode, Then Cathode, Then Anode, Then Cathode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316885|NCT03249454|FG008|Participant Flow|Cathode, Then Cathode, Then Sham, Then Anode, Then Anode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316886|NCT03249454|FG009|Participant Flow|Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316887|NCT03249454|FG010|Participant Flow|Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS|5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
11316888|NCT03249454|OG000|Outcome|Cathodal tsDCS|"Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level."
11316889|NCT03249454|OG001|Outcome|Anodal tsDCS|"Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level."
11316890|NCT03249454|OG002|Outcome|Sham tsDCS|"Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes."
11316891|NCT03249454|OG000|Outcome|Cathodal tsDCS|Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
11316892|NCT03249454|OG001|Outcome|Anodal tsDCS|Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
11316893|NCT03249454|OG002|Outcome|Sham tsDCS|Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
11316894|NCT03249454|EG000|Reported Event|Cathodal tsDCS|"Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level."
11316895|NCT03249454|EG001|Reported Event|Anodal tsDCS|"Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level."
11316896|NCT03249454|EG002|Reported Event|Sham tsDCS|"Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.~Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes."
11333341|NCT03512041|EG002|Reported Event|RLIC - 3 Cycles|"RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All participants undergo training on a discrete sequence pr"
11316897|NCT03249584|BG000|Baseline|OsteoCool™ RF Ablation in Thoracic/Lumbar Spine|Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.
11316898|NCT03249584|BG001|Baseline|OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum|Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.
11316899|NCT03249584|BG002|Baseline|Total|Total of all reporting groups
11316900|NCT03249584|FG000|Participant Flow|OsteoCool™ RF Ablation in Thoracic/Lumbar Spine|Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.
11316901|NCT03249584|FG001|Participant Flow|OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum|Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.
11316902|NCT03249584|OG000|Outcome|OsteoCool™ RF Ablation in Thoracic/Lumbar Spine|Subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies).
11316903|NCT03249584|OG000|Outcome|OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum|Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.
11316904|NCT03249584|EG000|Reported Event|Total OsteoCool™ RF Ablation|"Subjects underwent a single OsteoCool™ RF Ablation procedure.~OsteoCool™ RF Ablation: The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas."
11316905|NCT03249779|BG000|Baseline|Scrambler|"All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.~Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS"
11095174|NCT01556633|OG001|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
11316906|NCT03249779|FG000|Participant Flow|Scrambler|"All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.~Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS"
11316907|NCT03249779|OG000|Outcome|Scrambler|"All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.~Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS"
11316908|NCT03249779|EG000|Reported Event|Scrambler|"All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.~Scrambler: Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS"
11316909|NCT03249909|BG000|Baseline|Exufiber Ag+|Exufiber Ag+ included treatment for 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316910|NCT03249909|BG001|Baseline|Exufiber|Exufiber included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316911|NCT03249909|BG002|Baseline|Aquacel Ag Extra|Aquacel Ag Extra included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316912|NCT03249909|BG003|Baseline|Total|Total of all reporting groups
11316913|NCT03249909|FG000|Participant Flow|Exufiber Ag+|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11095175|NCT01556633|OG000|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
10827593|NCT00110617|BG002|Baseline|Total|Total of all reporting groups
11316914|NCT03249909|FG001|Participant Flow|Exufiber|Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316915|NCT03249909|FG002|Participant Flow|Aquacel Ag Extra|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316916|NCT03249909|OG000|Outcome|Exufiber Ag +|"Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.~Exufiber Ag+: gelling fibre dressing with silver~Exufiber: gelling fibre without silver~Aquacel Ag Extra: gelling fibre with silver"
11316917|NCT03249909|OG001|Outcome|Exufiber|"Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.~Exufiber Ag+: gelling fibre dressing with silver~Exufiber: gelling fibre without silver~Aquacel Ag Extra: gelling fibre with silver"
11316918|NCT03249909|OG002|Outcome|Aquacel® Ag Extra|"Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.~Exufiber Ag+: gelling fibre dressing with silver~Exufiber: gelling fibre without silver~Aquacel Ag Extra: gelling fibre with silver"
11316919|NCT03249909|OG000|Outcome|Exufiber Ag+|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316920|NCT03249909|OG001|Outcome|Exufiber|Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316921|NCT03249909|OG002|Outcome|Aquacel Ag Extra|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316922|NCT03249909|EG000|Reported Event|Exufiber Ag+|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316923|NCT03249909|EG001|Reported Event|Exufiber|Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316924|NCT03249909|EG002|Reported Event|Aquacel Ag Extra|Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.
11316925|NCT03249935|BG000|Baseline|Azithromycin|"Azithromycin 1 gm PO single dose given as directly observed~Azithromycin: Azithromycin 1 gm PO single dose given as directly observed"
11316926|NCT03249935|FG000|Participant Flow|Azithromycin|"Azithromycin 1 gm PO single dose given as directly observed~Azithromycin: Azithromycin 1 gm PO single dose given as directly observed"
11316927|NCT03249935|OG000|Outcome|Symptomatic|Symptomatic was defined as urethral discharge and/or dysuria at baseline.
11316928|NCT03249935|OG001|Outcome|Asymptomatic|Asymptomatic was defined as not having urethral discharge or dysuria at baseline.
11316929|NCT03249935|OG000|Outcome|Azithromycin|Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
11316930|NCT03249935|EG000|Reported Event|Azithromycin|"Azithromycin 1 gm PO single dose given as directly observed~Azithromycin: Azithromycin 1 gm PO single dose given as directly observed"
11316931|NCT03250182|BG000|Baseline|PT010|Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11316932|NCT03250182|FG000|Participant Flow|PT010|Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11316933|NCT03250182|OG000|Outcome|PT010|Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11316934|NCT03250182|EG000|Reported Event|PT010|Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
11316935|NCT03250234|BG000|Baseline|Adequate Carbohydrate First, Then Low Carbohydrate|"Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d~Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion"
11316936|NCT03250234|BG001|Baseline|Low Carbohydrate First, Then Adequate Carbohydrate|"Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d~Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.~For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion"
11316937|NCT03250234|BG002|Baseline|Total|Total of all reporting groups
11316938|NCT03250234|FG000|Participant Flow|Adequate Carbohydrate First, Then Low Carbohydrate|"Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d first, then Low carbohydrate diet 1.5 g/kg/d~Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion~7 day washout~Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion"
11316939|NCT03250234|FG001|Participant Flow|Low Carbohydrate First, Then Adequate Carbohydrate|"Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d first, then adequate carbohydrate diet 6.0 g/kg/d~Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.~For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion~7 day washout~Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion"
11316940|NCT03250234|OG000|Outcome|Adequate Carbohydrate|"Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d~Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion"
11316941|NCT03250234|OG001|Outcome|Low Carbohydrate|"Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d~Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.~For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion"
11316942|NCT03250234|EG000|Reported Event|Adequate Carbohydrate|"Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d~Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion"
11316943|NCT03250234|EG001|Reported Event|Low Carbohydrate|"Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d~Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.~For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion"
11316944|NCT03250689|BG000|Baseline|Placebo|Participants received one tablet of matching placebo twice daily orally with food for 14 days.
11316945|NCT03250689|BG001|Baseline|Danirixin Hydrobromide 35 mg|Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
11316946|NCT03250689|BG002|Baseline|Total|Total of all reporting groups
11316947|NCT03250689|FG000|Participant Flow|Placebo|Participants received one tablet of matching placebo twice daily orally with food for 14 days.
11316948|NCT03250689|FG001|Participant Flow|Danirixin Hydrobromide 35 mg|Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
11316949|NCT03250689|OG000|Outcome|Placebo|Participants received one tablet of matching placebo twice daily orally with food for 14 days.
11316950|NCT03250689|OG001|Outcome|Danirixin Hydrobromide 35 mg|Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
11316951|NCT03250689|OG000|Outcome|Danirixin Hydrobromide 35 mg|Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
11316952|NCT03250689|EG000|Reported Event|Placebo|Participants received one tablet of matching placebo twice daily orally with food for 14 days.
11316953|NCT03250689|EG001|Reported Event|Danirixin Hydrobromide 35 mg|Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
11316954|NCT03250845|BG000|Baseline|All Study Participants|Baseline characteristics of the study population (30 participants).
11316955|NCT03250845|FG000|Participant Flow|All Study Participants|"30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.~Dosing was set at 0.4 g/kg for both infusions."
11316956|NCT03250845|OG000|Outcome|All Study Participants|"30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.~Dosing was set at 0.4 g/kg for both infusions."
11316957|NCT03250845|OG000|Outcome|All Study Participants|30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
11316958|NCT03250845|EG000|Reported Event|Multigam 5% Infusion|30 participants who received Multigam 5% intravenous immunoglobulin (IVIg).
11316959|NCT03250845|EG001|Reported Event|Multigam 10% Infusion|30 participants who received Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks after their Multigam 5% infusion.
11316960|NCT03251482|BG000|Baseline|JNJ-64179375 0.3 mg/kg and Apixaban Placebo|Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.
11316961|NCT03251482|BG001|Baseline|JNJ-64179375 0.6 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316962|NCT03251482|BG002|Baseline|JNJ-64179375 1.2 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316963|NCT03251482|BG003|Baseline|JNJ-64179375 1.8 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316964|NCT03251482|BG004|Baseline|Apixaban 2.5 mg and JNJ-64179375 Placebo IV|Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
11316965|NCT03251482|BG005|Baseline|Total|Total of all reporting groups
11316966|NCT03251482|FG000|Participant Flow|JNJ-64179375 0.3 mg/kg and Apixaban Placebo|Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.
11316967|NCT03251482|FG001|Participant Flow|JNJ-64179375 0.6 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316968|NCT03251482|FG002|Participant Flow|JNJ-64179375 1.2 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316969|NCT03251482|FG003|Participant Flow|JNJ-64179375 1.8 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316970|NCT03251482|FG004|Participant Flow|Apixaban 2.5 mg and JNJ-64179375 Placebo IV|Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
11316971|NCT03251482|OG000|Outcome|JNJ-64179375 0.3 mg/kg and Apixaban Placebo|Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.
11316972|NCT03251482|OG001|Outcome|JNJ-64179375 0.6 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316973|NCT03251482|OG002|Outcome|JNJ-64179375 1.2 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316974|NCT03251482|OG003|Outcome|JNJ-64179375 1.8 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316975|NCT03251482|OG004|Outcome|Apixaban 2.5 mg and JNJ-64179375 Placebo IV|Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
11316976|NCT03251482|EG000|Reported Event|JNJ-64179375 0.3 mg/kg and Apixaban Placebo|Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.
11316977|NCT03251482|EG001|Reported Event|JNJ-64179375 0.6 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316978|NCT03251482|EG002|Reported Event|JNJ-64179375 1.2 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316979|NCT03251482|EG003|Reported Event|JNJ-64179375 1.8 mg/kg and Apixaban Placebo|Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
11316980|NCT03251482|EG004|Reported Event|Apixaban 2.5 mg and JNJ-64179375 Placebo IV|Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
11316981|NCT03251937|BG000|Baseline|Spinal Cord Stimulation|"Spectra WaveWriter SCS System~Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy"
11316982|NCT03251937|FG000|Participant Flow|Spinal Cord Stimulation|"Spectra WaveWriter SCS System~Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy"
11316983|NCT03251937|OG000|Outcome|Spinal Cord Stimulation|"Spectra WaveWriter SCS System~Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy"
11316984|NCT03251937|EG000|Reported Event|Spinal Cord Stimulation|"Spectra WaveWriter SCS System~Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy"
11316985|NCT03251963|BG000|Baseline|Fixed Dose Enoxaparin|"Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.~Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11095176|NCT01556633|OG000|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
11316986|NCT03251963|BG001|Baseline|Weight Tiered Enoxaparin|"Eligible patients will be receive weight tiered daily enoxaparin. Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.~Variable Dose Enoxaparin: Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316987|NCT03251963|BG002|Baseline|Total|Total of all reporting groups
11316988|NCT03251963|FG000|Participant Flow|Fixed Dose Enoxaparin|"Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.~Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
10827594|NCT00110617|FG000|Participant Flow|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
11316989|NCT03251963|FG001|Participant Flow|Weight Tiered Enoxaparin|"Eligible patients will be receive weight tiered daily enoxaparin. Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.~Variable Dose Enoxaparin: Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316990|NCT03251963|OG000|Outcome|Fixed Dose Enoxaparin|"Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.~Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316991|NCT03251963|OG001|Outcome|Weight Tiered Enoxaparin|"Eligible patients will be receive weight tiered daily enoxaparin. Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.~Variable Dose Enoxaparin: Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316992|NCT03251963|EG000|Reported Event|Fixed Dose Enoxaparin|"Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.~Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316993|NCT03251963|EG001|Reported Event|Weight Tiered Enoxaparin|"Eligible patients will be receive weight tiered daily enoxaparin. Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.~Variable Dose Enoxaparin: Patients <70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose."
11316994|NCT03252015|BG000|Baseline|Cohort 1a (Placebo+Probe Drug Cocktail)|Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
11316995|NCT03252015|BG001|Baseline|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
11316996|NCT03252015|BG002|Baseline|Cohort 2a (Placebo)|Placebo administered daily PO, Days 1-7.
11316997|NCT03252015|BG003|Baseline|Cohort 2b (400 mg Lasmiditan)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11316998|NCT03252015|BG004|Baseline|Total|Total of all reporting groups
11316999|NCT03252015|FG000|Participant Flow|Cohort 1a (Placebo+Probe Drug Cocktail)|Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.
11317000|NCT03252015|FG001|Participant Flow|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.
11317001|NCT03252015|FG002|Participant Flow|Cohort 2a (Placebo)|Placebo administered daily PO, Days 1-7.
11317002|NCT03252015|FG003|Participant Flow|Cohort 2b (400 mg Lasmiditan)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317003|NCT03252015|OG000|Outcome|Cohort 1a (Placebo+Probe Drug Cocktail)|Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
11317004|NCT03252015|OG001|Outcome|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
11317005|NCT03252015|OG002|Outcome|Cohort 2a (Placebo)|Placebo administered daily PO, Days 1-7.
11317006|NCT03252015|OG003|Outcome|Cohort 2b (400 mg Lasmiditan)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317007|NCT03252015|OG000|Outcome|200 mg Lasmiditan|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
11317008|NCT03252015|OG001|Outcome|400 mg Lasmiditan|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317009|NCT03252015|OG000|Outcome|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7..
11317010|NCT03252015|OG001|Outcome|Cohort 2b (400 mg Lasmiditan)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317011|NCT03252015|OG000|Outcome|200 mg Lasmiditan+Probe Drug Cocktail (Cohort 1)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
11317012|NCT03252015|OG001|Outcome|400 mg Lasmiditan (Cohort 2)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317013|NCT03252015|OG000|Outcome|Cohort 1a (Placebo+Probe Drug Cocktail)|Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.
11317014|NCT03252015|OG001|Outcome|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7..
11317015|NCT03252015|OG000|Outcome|200 mg Lasmiditan|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7
11317016|NCT03252015|OG000|Outcome|Participants Who Received Probe Drug Cocktail|Probe drug cocktail was administered PO alone to all participants on Day -3.
11317017|NCT03252015|OG001|Outcome|Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.
11317018|NCT03252015|EG000|Reported Event|Probe Drug Cocktail (Cohort 1)|Probe drug cocktail administered on Day 13 and Day 7
11317019|NCT03252015|EG001|Reported Event|200 mg Lasmiditan QD (Cohort 1)|Daily,oral (PO), 200 mg lasmiditan Days 1-6
11317020|NCT03252015|EG002|Reported Event|200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)|Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
11317021|NCT03252015|EG003|Reported Event|Placebo QD (Cohort 1)|Placebo administered daily PO, Days 1-7
11317022|NCT03252015|EG004|Reported Event|Placebo QD + Probe Drug Cocktail (Cohort 1)|Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7
11317023|NCT03252015|EG005|Reported Event|400 mg Lasmiditan QD (Cohort 2)|Daily,oral (PO), 400 mg lasmiditan Days 1-7
11317024|NCT03252015|EG006|Reported Event|Placebo QD (Cohort 2)|Placebo administered daily PO, Days 1-7
11317025|NCT03252145|BG000|Baseline|Manual Lymph Drainage|"Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid."
11317026|NCT03252145|BG001|Baseline|Negative Pressure|"PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia."
11317027|NCT03252145|BG002|Baseline|Total|Total of all reporting groups
11317028|NCT03252145|FG000|Participant Flow|Manual Lymph Drainage|"Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid."
11317029|NCT03252145|FG001|Participant Flow|Negative Pressure|"PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia."
11317030|NCT03252145|OG000|Outcome|Manual Lymph Drainage|"Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid."
11317031|NCT03252145|OG001|Outcome|Negative Pressure|"PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia."
11317032|NCT03252145|EG000|Reported Event|Manual Lymph Drainage|"Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid."
11317033|NCT03252145|EG001|Reported Event|Negative Pressure|"PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb~PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia."
11317034|NCT03252353|BG000|Baseline|Octreotide Capsules|"Octreotide capsules~octreotide capsules: octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)"
11317035|NCT03252353|BG001|Baseline|Matching Placebo|"Matching placebo capsules~Matching placebo: Matching placebo capsules"
11317036|NCT03252353|BG002|Baseline|Total|Total of all reporting groups
11317037|NCT03252353|FG000|Participant Flow|Octreotide Capsules|"Octreotide capsules~octreotide capsules: octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)"
11317038|NCT03252353|FG001|Participant Flow|Matching Placebo|"Matching placebo capsules~Matching placebo: Matching placebo capsules"
11317039|NCT03252353|OG000|Outcome|Octreotide Capsules|"Octreotide capsules~octreotide capsules: octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)"
11317040|NCT03252353|OG001|Outcome|Matching Placebo|Matching placebo capsules
11317041|NCT03252353|OG000|Outcome|Octreotide Capsules|Octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)
11317042|NCT03252353|OG001|Outcome|Placebo|Matching placebo
11317043|NCT03252353|OG000|Outcome|Octreotide Capsules|Octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
11317044|NCT03252353|EG000|Reported Event|Octreotide Capsules|"Octreotide capsules~octreotide capsules: octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)"
11317045|NCT03252353|EG001|Reported Event|Matching Placebo|"Matching placebo capsules~Matching placebo: Matching placebo capsules"
11317046|NCT03252431|BG000|Baseline|F-627|"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.~F-627: single dose pre-filled syringe"
11317047|NCT03252431|BG001|Baseline|Neulasta|"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles~Neulasta: single dose pre-filled syringe"
11317048|NCT03252431|BG002|Baseline|Total|Total of all reporting groups
11317049|NCT03252431|FG000|Participant Flow|F-627|"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.~F-627: single dose pre-filled syringe"
11317050|NCT03252431|FG001|Participant Flow|Neulasta|"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles~Neulasta: single dose pre-filled syringe"
11317051|NCT03252431|OG000|Outcome|F-627|"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.~F-627: single dose pre-filled syringe"
11317052|NCT03252431|OG001|Outcome|Neulasta|"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles~Neulasta: single dose pre-filled syringe"
11317053|NCT03252431|EG000|Reported Event|F-627|"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.~F-627: single dose pre-filled syringe"
11317054|NCT03252431|EG001|Reported Event|Neulasta|"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles~Neulasta: single dose pre-filled syringe"
11335939|NCT03559062|FG001|Participant Flow|TEZ/IVA|Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
10827595|NCT00110617|FG001|Participant Flow|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
10827596|NCT00110617|OG000|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
11335940|NCT03559062|FG002|Participant Flow|Ivacaftor|Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks.
11335941|NCT03559062|OG000|Outcome|TEZ/IVA|Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
11317055|NCT03252964|BG000|Baseline|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11317056|NCT03252964|FG000|Participant Flow|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11317057|NCT03252964|OG000|Outcome|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11317058|NCT03252964|EG000|Reported Event|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11317059|NCT03253094|BG000|Baseline|Ibrexafungerp 750-mg|750 mg QD for 1 day only
11317060|NCT03253094|BG001|Baseline|Ibrexafungerp 300-mg|300 mg BID for 1 day only
11317061|NCT03253094|BG002|Baseline|Ibrexafungerp 450-mg|450 mg BID for 1 day only
11317062|NCT03253094|BG003|Baseline|Ibrexafungerp 150-mg|150 mg BID for 3 days
11317063|NCT03253094|BG004|Baseline|Ibrexafungerp 300-mg (3 Days)|300 mg BID for 3 days
10827597|NCT00110617|OG001|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
11317064|NCT03253094|BG005|Baseline|Fluconazole|150 mg QD for 1 day
11317065|NCT03253094|BG006|Baseline|Total|Total of all reporting groups
11317066|NCT03253094|FG000|Participant Flow|Ibrexafungerp 750-mg|750 mg QD for 1 day only
11317067|NCT03253094|FG001|Participant Flow|Ibrexafungerp 300-mg|300 mg BID for 1 day only
11317068|NCT03253094|FG002|Participant Flow|Ibrexafungerp 450-mg|450 mg BID for 1 day only
11317069|NCT03253094|FG003|Participant Flow|Ibrexafungerp 150-mg|150 mg BID for 3 days
11317070|NCT03253094|FG004|Participant Flow|Ibrexafungerp 300-mg (3 Days)|300 mg BID for 3 days
11317071|NCT03253094|FG005|Participant Flow|Fluconazole|150 mg QD for 1 day
11317072|NCT03253094|OG000|Outcome|Ibrexafungerp 750-mg|750 mg QD D1 only
11317073|NCT03253094|OG001|Outcome|Ibrexafungerp 300-mg|300 mg BID D1 only
11317074|NCT03253094|OG002|Outcome|Ibrexafungerp 450-mg|450 mg BID D1 only
11317075|NCT03253094|OG003|Outcome|Ibrexafungerp 150-mg|150 mg BID D1 to D3
10827598|NCT00110617|EG000|Reported Event|Period 1 Deferasirox (ICL670)|Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
10827599|NCT00110617|EG001|Reported Event|Period 1 Deferoxamine (DFO)|Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg.
10827600|NCT00110617|EG002|Reported Event|Period 2 Deferasirox (ICL670)|Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
11317076|NCT03253094|OG004|Outcome|Ibrexafungerp 300-mg D1 to D3|300 mg BID D1 to D3
11317077|NCT03253094|OG005|Outcome|Fluconazole|150 mg QD D1 only
11317078|NCT03253094|EG000|Reported Event|Ibrexafungerp 750-mg|750 mg QD D1 only
11317079|NCT03253094|EG001|Reported Event|Ibrexafungerp 300-mg|300 mg BID D1 only
11317080|NCT03253094|EG002|Reported Event|Ibrexafungerp 450-mg|450 mg BID D1 only
11317081|NCT03253094|EG003|Reported Event|Ibrexafungerp 150-mg|150 mg BID D1 to D3
11317082|NCT03253094|EG004|Reported Event|Ibrexafungerp 300-mg D1 to D3|300 mg BID D1 to D3
11317083|NCT03253094|EG005|Reported Event|Fluconazole|150 mg QD D1 only
11317084|NCT03254108|BG000|Baseline|OPC-61815 Injection 2mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
11317085|NCT03254108|BG001|Baseline|OPC-61815 Injection 4mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
11317086|NCT03254108|BG002|Baseline|OPC-61815 Injection 8mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
11317087|NCT03254108|BG003|Baseline|OPC-61815 Injection 16mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11317088|NCT03254108|BG004|Baseline|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11317089|NCT03254108|BG005|Baseline|Total|Total of all reporting groups
11317090|NCT03254108|FG000|Participant Flow|OPC-61815 Injection 2mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
11317091|NCT03254108|FG001|Participant Flow|OPC-61815 Injection 4mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
11317092|NCT03254108|FG002|Participant Flow|OPC-61815 Injection 8mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
11317093|NCT03254108|FG003|Participant Flow|OPC-61815 Injection 16mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11317094|NCT03254108|FG004|Participant Flow|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11317095|NCT03254108|OG000|Outcome|OPC-61815 Injection 2mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
11317096|NCT03254108|OG001|Outcome|OPC-61815 Injection 4mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
11317097|NCT03254108|OG002|Outcome|OPC-61815 Injection 8mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
11317098|NCT03254108|OG003|Outcome|OPC-61815 Injection 16mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11317099|NCT03254108|OG004|Outcome|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11317100|NCT03254108|EG000|Reported Event|OPC-61815 Injection 2mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
11095177|NCT01556633|OG001|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
11317101|NCT03254108|EG001|Reported Event|OPC-61815 Injection 4mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
11317102|NCT03254108|EG002|Reported Event|OPC-61815 Injection 8mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
11317103|NCT03254108|EG003|Reported Event|OPC-61815 Injection 16mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
11317104|NCT03254108|EG004|Reported Event|Tolvaptan Tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
11317105|NCT03254134|BG000|Baseline|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317106|NCT03254134|BG001|Baseline|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317107|NCT03254134|BG002|Baseline|Total|Total of all reporting groups
11317108|NCT03254134|FG000|Participant Flow|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317109|NCT03254134|FG001|Participant Flow|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317110|NCT03254134|OG000|Outcome|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317111|NCT03254134|OG001|Outcome|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317112|NCT03254134|EG000|Reported Event|Dabigatran|Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317113|NCT03254134|EG001|Reported Event|Warfarin|Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
11317114|NCT03254147|BG000|Baseline|Patients Prescribed With Non-warfarin Oral Anti Coagulants|Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
11317115|NCT03254147|FG000|Participant Flow|Patients Prescribed With Non-warfarin Oral Anti Coagulants|Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
11317116|NCT03254147|OG000|Outcome|Patients Prescribed With Non-warfarin Oral Anti Coagulants|Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
11317117|NCT03254147|EG000|Reported Event|Patients Prescribed With Non-warfarin Oral Anti Coagulants|Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
11317118|NCT03254459|BG000|Baseline|Standard of Care Narcotic Therapy|"Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.~Morphine: Morphine~Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet"
11317119|NCT03254459|BG001|Baseline|Buprenorphine Sublingual Spray 0.5 mg|"Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.~Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg"
11317120|NCT03254459|BG002|Baseline|Total|Total of all reporting groups
11317121|NCT03254459|FG000|Participant Flow|Standard of Care Narcotic Therapy|"Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.~Morphine: Morphine~Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet"
11317122|NCT03254459|FG001|Participant Flow|Buprenorphine Sublingual Spray 0.5 mg|"Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.~Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg"
11317123|NCT03254459|OG000|Outcome|Standard of Care Narcotic Therapy|"Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.~Morphine: Morphine~Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet"
11317124|NCT03254459|OG001|Outcome|Buprenorphine Sublingual Spray 0.5 mg|"Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.~Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg"
11317125|NCT03254459|EG000|Reported Event|Standard of Care Narcotic Therapy|"Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.~Morphine: Morphine~Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet"
11317126|NCT03254459|EG001|Reported Event|Buprenorphine Sublingual Spray 0.5 mg|"Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.~Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg"
11317127|NCT03254602|BG000|Baseline|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317128|NCT03254602|FG000|Participant Flow|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317129|NCT03254602|OG000|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
10827601|NCT00110617|EG003|Reported Event|Period 2 Deferoxamine (DFO) Then ICL670|Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period.
10827602|NCT00110812|BG000|Baseline|No IL-2|Participants will receive no aldesleukin or HAART
11317130|NCT03254602|EG000|Reported Event|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317131|NCT03254719|BG000|Baseline|Treatment Arm|"All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.~Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic."
11317132|NCT03254719|FG000|Participant Flow|Treatment Arm|"All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.~Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic."
11317133|NCT03254719|OG000|Outcome|Treatment Arm|"All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.~Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic."
11317134|NCT03254719|EG000|Reported Event|Treatment Arm|"All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.~Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic."
11317135|NCT03255187|BG000|Baseline|Fish Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.~Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)]."
11317136|NCT03255187|BG001|Baseline|Sunflower Seed Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.~Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6)."
11317137|NCT03255187|BG002|Baseline|Total|Total of all reporting groups
11317138|NCT03255187|FG000|Participant Flow|Fish Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.~Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)]."
11317139|NCT03255187|FG001|Participant Flow|Sunflower Seed Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.~Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6)."
11317140|NCT03255187|OG000|Outcome|Fish Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.~Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)]."
11317141|NCT03255187|OG001|Outcome|Sunflower Seed Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.~Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6)."
11317142|NCT03255187|EG000|Reported Event|Fish Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.~Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)]."
11317143|NCT03255187|EG001|Reported Event|Sunflower Seed Oil Supplementation|"This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.~Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6)."
11317144|NCT03255291|BG000|Baseline|Risk Display Format:Risk Ladder:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317145|NCT03255291|BG001|Baseline|Risk Display Format:Risk Ladder:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
10827603|NCT00110812|BG001|Baseline|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
10827604|NCT00110812|BG002|Baseline|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
10827605|NCT00110812|BG003|Baseline|Total|Total of all reporting groups
10827606|NCT00110812|FG000|Participant Flow|No IL-2|Participants will receive no aldesleukin or HAART during the main study or extension
11095178|NCT01556633|EG000|Reported Event|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
11317146|NCT03255291|BG002|Baseline|Risk Display Format:Table:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317147|NCT03255291|BG003|Baseline|Risk Display Format:Table:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317148|NCT03255291|BG004|Baseline|Risk Display Format:Text:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317149|NCT03255291|BG005|Baseline|Risk Display Format:Text:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317150|NCT03255291|BG006|Baseline|Total|Total of all reporting groups
11317151|NCT03255291|FG000|Participant Flow|Risk Display Format:Risk Ladder:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317152|NCT03255291|FG001|Participant Flow|Risk Display Format:Risk Ladder:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317153|NCT03255291|FG002|Participant Flow|Risk Display Format:Table:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317154|NCT03255291|FG003|Participant Flow|Risk Display Format:Table: Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317155|NCT03255291|FG004|Participant Flow|Risk Display Format:Text:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317156|NCT03255291|FG005|Participant Flow|Risk Display Format:Text:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317157|NCT03255291|OG000|Outcome|Risk Display Format:Risk Ladder:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317158|NCT03255291|OG001|Outcome|Risk Display Format:Risk Ladder:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317159|NCT03255291|OG002|Outcome|Risk Display Format:Table:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11335942|NCT03559062|OG000|Outcome|Placebo|Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks.
11335943|NCT03559062|OG001|Outcome|TEZ/IVA|Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
11095179|NCT01556633|EG001|Reported Event|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
11317160|NCT03255291|OG003|Outcome|Risk Display Format:Table: Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317161|NCT03255291|OG004|Outcome|Risk Display Format:Text:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317162|NCT03255291|OG005|Outcome|Risk Display Format:Text:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317163|NCT03255291|OG000|Outcome|Risk Display Format: Risk Ladder|-The personalized risk estimates were shown to participants as a risk ladder.
11317164|NCT03255291|OG001|Outcome|Risk Display Format: Table|-The personalized risk estimates were shown to participants as a table.
11317165|NCT03255291|OG002|Outcome|Risk Display Format: Text|-The personalized risk estimates were shown to participants as text.
11317166|NCT03255291|OG000|Outcome|Mental Imagery Behavior: Exercise|-Participants engaged in mental imagery related to exercise goals
11317167|NCT03255291|EG000|Reported Event|Risk Display Format:Risk Ladder:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317168|NCT03255291|EG001|Reported Event|Risk Display Format:Risk Ladder:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317169|NCT03255291|EG002|Reported Event|Risk Display Format:Table:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317170|NCT03255291|EG003|Reported Event|Risk Display Format:Table:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11335944|NCT03559062|OG002|Outcome|Ivacaftor|Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks.
11317171|NCT03255291|EG004|Reported Event|Risk Display Format:Text:Imagery Behavior:Exercise|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317172|NCT03255291|EG005|Reported Event|Risk Display Format:Text:Imagery Behavior:Sleep|"With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.~Participants take Baseline Survey 1.~Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.~Participants take Baseline Survey 2.~Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).~Participants take surveys via text at the end of each week for 4 weeks.~90 days post-baseline, participants complete a survey sent through the mail.~Participants may be contacted for another survey 1 year later."
11317173|NCT03255382|BG000|Baseline|Fumaderm|Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
11317174|NCT03255382|BG001|Baseline|Risankizumab|Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
11317175|NCT03255382|BG002|Baseline|Total|Total of all reporting groups
11317176|NCT03255382|FG000|Participant Flow|Fumaderm|Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
11317177|NCT03255382|FG001|Participant Flow|Risankizumab|Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
11317178|NCT03255382|OG000|Outcome|Fumaderm|Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
11317179|NCT03255382|OG001|Outcome|Risankizumab|Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
11317180|NCT03255382|OG001|Outcome|Risankizumab|Participants randomized to receive open-label risankizumab 150 mg subcutaneous injection at Weeks 0, 4, and 16.
11317181|NCT03255382|EG000|Reported Event|Fumaderm|Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
10827607|NCT00110812|FG001|Participant Flow|IL-2 Without ART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
11317182|NCT03255382|EG001|Reported Event|Risankizumab|Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
11317183|NCT03255655|BG000|Baseline|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317184|NCT03255655|BG001|Baseline|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317185|NCT03255655|BG002|Baseline|Total|Total of all reporting groups
11317186|NCT03255655|FG000|Participant Flow|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317187|NCT03255655|FG001|Participant Flow|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317188|NCT03255655|OG000|Outcome|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317189|NCT03255655|OG001|Outcome|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317190|NCT03255655|EG000|Reported Event|ITU Treatment for Chronic Plantar Fasciitis|"Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
11317191|NCT03255655|EG001|Reported Event|Sham ITU Treatment for Chronic Plantar Fasciitis|"Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.~Intense Therapeutic Ultrasound Treatment - ITU"
10827608|NCT00110812|FG002|Participant Flow|IL-2 With Pericycle HAART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.
11317192|NCT03255733|BG000|Baseline|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317193|NCT03255733|FG000|Participant Flow|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317194|NCT03255733|OG000|Outcome|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317195|NCT03255733|EG000|Reported Event|Intense Therapeutic Ultrasound Treatment|"Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.~Intense Therapeutic Ultrasound Treatment"
11317196|NCT03255824|BG000|Baseline|Propofol Group|"Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.~Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery."
11317197|NCT03255824|BG001|Baseline|Dexmedetomidine Group|"Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.~Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery."
11317198|NCT03255824|BG002|Baseline|Total|Total of all reporting groups
11317199|NCT03255824|FG000|Participant Flow|Propofol Group|"Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.~Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery."
11317200|NCT03255824|FG001|Participant Flow|Dexmedetomidine Group|"Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.~Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery."
11317201|NCT03255824|OG000|Outcome|Propofol Group|"Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.~Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery."
11317202|NCT03255824|OG001|Outcome|Dexmedetomidine Group|"Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.~Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery."
11317203|NCT03255824|EG000|Reported Event|Propofol Group|"Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.~Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery."
11317204|NCT03255824|EG001|Reported Event|Dexmedetomidine Group|"Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.~Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery."
11317205|NCT03255902|BG000|Baseline|Families Attending Parenting Classes|"Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires~Parenting classes: Parenting Classes:The Incredible Years curriculum"
11317206|NCT03255902|FG000|Participant Flow|Families Attending Parenting Classes|"Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires~Parenting classes: Parenting Classes:The Incredible Years curriculum"
11317207|NCT03255902|OG000|Outcome|Families Attending Parenting Classes|"Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires~Parenting classes: Parenting Classes:The Incredible Years curriculum"
11317208|NCT03255902|EG000|Reported Event|Families Attending Parenting Class|"Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires.~Parenting Classes: The Incredible Years curriculum"
11317209|NCT03255941|BG000|Baseline|Clinic Provider Urban|"Clinic provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press."
11317210|NCT03255941|BG001|Baseline|Lay Provider Urban|"Lay Provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press."
11317211|NCT03255941|BG002|Baseline|Clinic Provider Rural|"Clinic provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press."
11317212|NCT03255941|BG003|Baseline|Lay Provider Rural|"Clinic provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press."
11317213|NCT03255941|BG004|Baseline|Total|Total of all reporting groups
11317214|NCT03255941|FG000|Participant Flow|Clinic Provider - Urban|Family Welfare Workers that are clinically trained providers in the urban setting of Karachi
11317215|NCT03255941|FG001|Participant Flow|Lay Provider - Urban|Lady Health Workers that are not clinically trained in the urban setting of Karachi
11317216|NCT03255941|FG002|Participant Flow|Clinic Provider - Rural|Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta
11317217|NCT03255941|FG003|Participant Flow|Lay Provider - Rural|Lady Health Workers that are not clinically trained providers in the rural setting of Thatta
11317218|NCT03255941|OG000|Outcome|Clinic Provider - Urban|"Urban Clinic Provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press."
11317219|NCT03255941|OG001|Outcome|Lay Provider - Urban|"Urban Lay Provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA"
11317220|NCT03255941|OG002|Outcome|Clinic Provider - Rural|"Rural Clinic Provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA"
11317221|NCT03255941|OG003|Outcome|Lay Provider - Rural|"Rural Lay Provider providing DMPA or Sayana Press~The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA"
11317222|NCT03255941|OG000|Outcome|Clinic Providers - Urban|Appropriateness of counseling by Urban Clinic providers.
11317223|NCT03255941|OG001|Outcome|Lay Provider - Urban|Appropriateness of counseling by Urban Lay providers.
11317224|NCT03255941|OG002|Outcome|Clinic Provider - Rural|Appropriateness of counseling by Rural Clinical Providers
11317225|NCT03255941|OG003|Outcome|Lay Provider - Rural|Appropriateness of counseling by Rural Lay Providers
11317226|NCT03255941|OG000|Outcome|DMPA - IM Urban|"Provider providing DMPA- Intra muscular~Proportion of clients highly satisfied with their DMPA Method"
11317227|NCT03255941|OG001|Outcome|DMPA - SC - Urban|"Provider providing DMPA - sub cutaneous~Prop[portion of clients highly satisfied with the DMPA method provided to them"
11317228|NCT03255941|OG002|Outcome|DMPA-IM Rural|"Provider providing DMPA- Intra muscular~Proportion of clients highly satisfied with their DMPA Method"
11317229|NCT03255941|OG003|Outcome|DMPA-SC- Rural|"Provider providing DMPA - sub cutaneous~Prop[portion of clients highly satisfied with the DMPA method provided to them"
11317230|NCT03255941|OG000|Outcome|Clinic Provider - Urban|Urban Clinic provider providing DMPA services
11317231|NCT03255941|OG001|Outcome|Lay Provider- Urban|Urban Lay provider providing DMPA services
11317232|NCT03255941|OG002|Outcome|Clinic Provider - Rural|Rural Clinic provider providing DMPA services
11317233|NCT03255941|OG003|Outcome|Lay Provider - Rural|Lay rural provider providing DMPA services
11317234|NCT03255941|EG000|Reported Event|Lay Provider & DMPA|"Lay provider providing DMPA~DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA."
11317235|NCT03255941|EG001|Reported Event|Lay Provider & Sayana Press|"Lay Provider providing Sayana Press~Sayana Press: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press"
11317236|NCT03255941|EG002|Reported Event|Clinic Provider & DMPA|"Clinic provider providing DMPA~DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA."
11317237|NCT03255941|EG003|Reported Event|Clinic Provider and Sayana Press|"Clinic provider providing Sayana Press~Sayana Press: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press"
11317238|NCT03255980|BG000|Baseline|Breast Cancer Group: Xonrid+SOC|Patients treated with the device under evaluation and according to MASCC guidelines
11317239|NCT03255980|BG001|Baseline|Breast Cancer Group: SOC|Patients treated with Standard of Care according to MASCC guidelines
11317240|NCT03255980|BG002|Baseline|Head and Neck Cancer Group: Xonrid + SOC|H&N Patients treated with the device under evaluation and according to MASCC guidelines
11317241|NCT03255980|BG003|Baseline|Head and Neck Cancer Group: SOC|H&N Cancer Patients treated with Standard of Care according to MASCC guidelines
11317242|NCT03255980|BG004|Baseline|Total|Total of all reporting groups
11317243|NCT03255980|FG000|Participant Flow|Breast Cancer Group: Xonrid+SOC|Patients treated with the device under evaluation and according to MASCC guidelines
11317244|NCT03255980|FG001|Participant Flow|Breast Cancer Group: SOC|Patients treated with Standard of Care according to MASCC guidelines
10827609|NCT00110812|OG000|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
10827610|NCT00110812|OG001|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
11317245|NCT03255980|FG002|Participant Flow|Head and Neck Cancer Group: Xonrid + SOC|H&N Patients treated with the device under evaluation and according to MASCC guidelines
11317246|NCT03255980|FG003|Participant Flow|Head and Neck Cancer Group: SOC|H&N Cancer Patients treated with Standard of Care according to MASCC guidelines
11317247|NCT03255980|OG000|Outcome|Breast Cancer Group: Xonrid+SOC|Patients treated with the device under evaluation and according to MASCC guidelines
11317248|NCT03255980|OG001|Outcome|Breast Cancer Group: SOC|Patients with Breast Cancer treated with Standard of Care according to MASCC guidelines
11317249|NCT03255980|OG002|Outcome|Head and Neck Cancer Group: Xonrid + SOC|H&N Patients treated with the device under evaluation and according to MASCC guidelines
11317250|NCT03255980|OG003|Outcome|Head and Neck Cancer Group: SOC|H&N Cancer Patients treated with Standard of Care according to MASCC guidelines
11317251|NCT03255980|EG000|Reported Event|Breast Cancer: Xonrid® +SOC|"Xonrid® is a medical device for radiation dermatitis~Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy~Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines"
11317252|NCT03255980|EG001|Reported Event|Breast Cancer: Standard Of Care|Standard of care suggested by MASCC guidelines
11317253|NCT03255980|EG002|Reported Event|Head and Neck Cancer: Xonrid + SOC|"Xonrid® is a medical device for radiation dermatitis~Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy~Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines"
11317254|NCT03255980|EG003|Reported Event|Head and Neck Cancer: Standard of Care|Standard of care suggested by MASCC guidelines
11317255|NCT03256136|BG000|Baseline|Nivolumab Plus Ipilimumab EGFR|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317256|NCT03256136|BG001|Baseline|Nivolumab Plus Ipilimumab ALK|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317257|NCT03256136|BG002|Baseline|Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317258|NCT03256136|BG003|Baseline|Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317259|NCT03256136|BG004|Baseline|Total|Total of all reporting groups
11317260|NCT03256136|FG000|Participant Flow|Nivolumab Plus Ipilimumab EGFR|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317261|NCT03256136|FG001|Participant Flow|Nivolumab Plus Ipilimumab ALK|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317262|NCT03256136|FG002|Participant Flow|Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317263|NCT03256136|FG003|Participant Flow|Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317264|NCT03256136|OG000|Outcome|Nivolumab Plus Ipilimumab EGFR|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317265|NCT03256136|OG001|Outcome|Nivolumab Plus Ipilimumab ALK|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317266|NCT03256136|OG002|Outcome|Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317267|NCT03256136|OG003|Outcome|Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317268|NCT03256136|EG000|Reported Event|Nivolumab Plus Ipilimumab EGFR|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317269|NCT03256136|EG001|Reported Event|Nivolumab Plus Ipilimumab ALK|"Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks~Nivolumab: will allow the body's immune system to work against tumor cells~Ipilimumab: will allow the body's immune system to work against tumor cells"
11317270|NCT03256136|EG002|Reported Event|Nivolumab + Carboplatin + Pemetrexed With EGFR Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317271|NCT03256136|EG003|Reported Event|Nivolumab + Carboplatin + Pemetrexed ALK Chemo Naive|"Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks~Carboplatin: Chemotherapy~Nivolumab: will allow the body's immune system to work against tumor cells~pemetrexed: Chemo therapy"
11317272|NCT03256162|BG000|Baseline|Ketamine|"Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart."
11317273|NCT03256162|BG001|Baseline|Midazolam|"Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart."
11317274|NCT03256162|BG002|Baseline|Total|Total of all reporting groups
11317275|NCT03256162|FG000|Participant Flow|Ketamine|"Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart."
11317276|NCT03256162|FG001|Participant Flow|Midazolam|"Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart."
11317277|NCT03256162|OG000|Outcome|Ketamine|"Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart."
11317278|NCT03256162|OG001|Outcome|Midazolam|"Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart."
11317279|NCT03256162|EG000|Reported Event|Ketamine|"Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.~Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart."
11317280|NCT03256162|EG001|Reported Event|Midazolam|"Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.~Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart."
11317281|NCT03256253|BG000|Baseline|Pregabalin|"pregabalin up to daily dose of 600 mg~Pregabalin: pregabalin up to 600 mg/day"
11317282|NCT03256253|FG000|Participant Flow|Pregabalin|"pregabalin up to daily dose of 600 mg~Pregabalin: pregabalin up to 600 mg/day"
11317283|NCT03256253|OG000|Outcome|Pregabalin|"pregabalin up to daily dose of 600 mg~Pregabalin: pregabalin up to 600 mg/day"
11317284|NCT03256253|EG000|Reported Event|Pregabalin|"pregabalin up to daily dose of 600 mg~Pregabalin: pregabalin up to 600 mg/day"
11317285|NCT03256526|BG000|Baseline|Placebo|Placebo matched to PF-06835919 tablets once daily (QD) were administered orally.
11317286|NCT03256526|BG001|Baseline|PF-06835919 75 mg|PF-06835919 75 mg tablets QD were administered orally.
11317287|NCT03256526|BG002|Baseline|PF-06835919 300 mg|PF-06835919 300 mg tablets QD were administered orally.
11317288|NCT03256526|BG003|Baseline|Total|Total of all reporting groups
11317289|NCT03256526|FG000|Participant Flow|Placebo|Placebo matched to PF-06835919 tablets once daily (QD) were administered orally.
11317290|NCT03256526|FG001|Participant Flow|PF-06835919 75 mg|PF-06835919 75 mg tablets QD were administered orally.
11317291|NCT03256526|FG002|Participant Flow|PF-06835919 300 mg|PF-06835919 300mg tablets QD were administered orally.
11317292|NCT03256526|OG000|Outcome|Placebo|Placebo matched to PF-06835919 tablets once daily (QD) were administered orally.
11317293|NCT03256526|OG001|Outcome|PF-06835919 75 mg|PF-06835919 75 mg tablets QD were administered orally.
11317294|NCT03256526|OG002|Outcome|PF-06835919 300 mg|PF-06835919 300mg tablets QD were administered orally.
11317295|NCT03256526|EG000|Reported Event|Placebo|Placebo matched to PF-06835919 tablets once daily (QD) were administered orally.
11317296|NCT03256526|EG001|Reported Event|PF-06835919 75 mg|PF-06835919 75 mg tablets QD were administered orally.
11317297|NCT03256526|EG002|Reported Event|PF-06835919 300 mg|PF-06835919 300 mg tablets QD were administered orally.
11317298|NCT03256552|BG000|Baseline|All Subjects|All Subjects in the MITT Population
11317299|NCT03256552|FG000|Participant Flow|Overall Study|All Subjects Randomized
11317300|NCT03256552|OG000|Outcome|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
11317301|NCT03256552|OG001|Outcome|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
11317302|NCT03256552|OG002|Outcome|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
11317303|NCT03256552|OG003|Outcome|Placebo MDI|Placebo MDI
11317304|NCT03256552|EG000|Reported Event|GP MDI 28.8 µg|Glycopyrronium MDI 28.8 µg
11317305|NCT03256552|EG001|Reported Event|GP MDI 14.4 µg|Glycopyrronium 14.4 µg
11317306|NCT03256552|EG002|Reported Event|GP MDI 7.2 µg|Glycopyrronium 7.2 µg
11317307|NCT03256552|EG003|Reported Event|Placebo MDI|Placebo MDI
11317308|NCT03256578|BG000|Baseline|RFM Visible|"During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.~New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth."
11317309|NCT03256578|BG001|Baseline|RFM Masked|During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
11317310|NCT03256578|BG002|Baseline|Total|Total of all reporting groups
11317311|NCT03256578|FG000|Participant Flow|RFM Visible|"During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.~New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth."
11317312|NCT03256578|FG001|Participant Flow|RFM Masked|During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
11317313|NCT03256578|OG000|Outcome|RFM Visible|"During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.~New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth."
11317314|NCT03256578|OG001|Outcome|RFM Masked|During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
11317315|NCT03256578|EG000|Reported Event|RFM Visible|"During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.~New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth."
11317316|NCT03256578|EG001|Reported Event|RFM Masked|During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
11317317|NCT03256695|BG000|Baseline|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
11335945|NCT03559062|EG000|Reported Event|Placebo|Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks.
11335946|NCT03559062|EG001|Reported Event|TEZ/IVA|Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
11317318|NCT03256695|FG000|Participant Flow|ABS eMDPI|Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
11317319|NCT03256695|OG000|Outcome|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
11317320|NCT03256695|EG000|Reported Event|ABS eMDPI|Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
11317321|NCT03256799|BG000|Baseline|Ivacaftor/Ataluren|Ivacaftor/Ataluren
11317322|NCT03256799|FG000|Participant Flow|Ivacaftor/Ataluren|the combination treatment of Ivacaftor/Ataluren were to be given over a 48 week period
11317323|NCT03256799|OG000|Outcome|Ivacaftor/Ataluren|Ivacaftor/Ataluren combination therapy
11317324|NCT03256799|EG000|Reported Event|Ivacaftor/Ataluren|Ivacaftor/Ataluren
11317325|NCT03256851|BG000|Baseline|In-Person Delivered Exercise|"Participants in the in-person training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.~In-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317326|NCT03256851|BG001|Baseline|Telephone-Delivered Exercise|"Participants in the telephone-delivered training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.~Telephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317327|NCT03256851|BG002|Baseline|Total|Total of all reporting groups
11317328|NCT03256851|FG000|Participant Flow|In-Person Delivered Exercise|"Participants in the in-person training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.~In-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317329|NCT03256851|FG001|Participant Flow|Telephone-Delivered Exercise|"Participants in the telephone-delivered training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.~Telephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317330|NCT03256851|OG000|Outcome|In-Person Delivered Exercise|"Participants in the in-person training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.~In-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317331|NCT03256851|OG001|Outcome|Telephone-Delivered Exercise|"Participants in the telephone-delivered training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.~Telephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317332|NCT03256851|EG000|Reported Event|In-Person Delivered Exercise|"Participants in the in-person training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.~In-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317333|NCT03256851|EG001|Reported Event|Telephone-Delivered Exercise|"Participants in the telephone-delivered training group will:~participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.~receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.~Telephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week."
11317334|NCT03256968|BG000|Baseline|Ataluren Administration|"dose of the drug administered (mg/kg body weight)~Ataluren: ataluren"
11317335|NCT03256968|FG000|Participant Flow|Ataluren Administration|"dose of the drug administered (mg/kg body weight)~Ataluren: ataluren"
11317336|NCT03256968|OG000|Outcome|Ataluren Administration|"dose of the drug administered (mg/kg body weight)~Ataluren: ataluren"
11317337|NCT03256968|EG000|Reported Event|Ataluren Administration|"dose of the drug administered (mg/kg body weight)~Ataluren: ataluren"
11317338|NCT03257189|BG000|Baseline|Device Monitoring|"This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.~This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.~Physiological signal monitor: Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.~Heart rate and heart rate variability comparison device: FDA cleared reference device that monitors heart rate and heart rate variability in subjects~Respiration rate comparison device: FDA cleared reference device that monitors respiration rate in subjects~Activity classification: Visual annotation of subject posture and other activities used for reference"
11317339|NCT03257189|FG000|Participant Flow|Device Monitoring|"This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.~This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.~Physiological signal monitor: Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.~Heart rate and heart rate variability comparison device: FDA cleared reference device that monitors heart rate and heart rate variability in subjects~Respiration rate comparison device: FDA cleared reference device that monitors respiration rate in subjects~Activity classification: Visual annotation of subject posture and other activities used for reference"
11317340|NCT03257189|OG000|Outcome|Device Monitoring|"This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.~This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.~Physiological signal monitor: Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.~Heart rate and heart rate variability comparison device: FDA cleared reference device that monitors heart rate and heart rate variability in subjects~Respiration rate comparison device: FDA cleared reference device that monitors respiration rate in subjects~Activity classification: Visual annotation of subject posture and other activities used for reference"
11317341|NCT03257189|EG000|Reported Event|Device Monitoring|"This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.~This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.~Physiological signal monitor: Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.~Heart rate and heart rate variability comparison device: FDA cleared reference device that monitors heart rate and heart rate variability in subjects~Respiration rate comparison device: FDA cleared reference device that monitors respiration rate in subjects~Activity classification: Visual annotation of subject posture and other activities used for reference"
10827611|NCT00110812|OG002|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
10827612|NCT00110812|OG000|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
10827613|NCT00110812|OG001|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
10827614|NCT00110812|OG000|Outcome|IL-2 With Pericycle HAART|
10827615|NCT00110812|OG000|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
10827616|NCT00110812|OG001|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
10827617|NCT00110812|EG000|Reported Event|IL-2 With Pericylce HAART|
10827618|NCT00110812|EG001|Reported Event|IL-2 Without ART|
10827619|NCT00110812|EG002|Reported Event|No IL-2|
10827620|NCT00110890|BG000|Baseline|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
10827621|NCT00110890|BG001|Baseline|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
10827622|NCT00110890|BG002|Baseline|Total|Total of all reporting groups
10827623|NCT00110890|FG000|Participant Flow|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
10827624|NCT00110890|FG001|Participant Flow|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
10827625|NCT00110890|OG000|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
10827626|NCT00110890|OG001|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
10827627|NCT00110890|EG000|Reported Event|Standard Care|
10827628|NCT00110890|EG001|Reported Event|Cinacalcet|
10827629|NCT00110994|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827630|NCT00110994|BG001|Baseline|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827631|NCT00110994|BG002|Baseline|Total|Total of all reporting groups
10827632|NCT00110994|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827633|NCT00110994|FG001|Participant Flow|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827634|NCT00110994|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827635|NCT00110994|OG001|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317342|NCT03257202|BG000|Baseline|All Study Participants|"Negative Control~Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel~Topical clindamycin alone using Clindamycin 1% Gel~BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together"
11317343|NCT03257202|FG000|Participant Flow|All Study Participants|All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide
11317344|NCT03257202|OG000|Outcome|Negative Control|The participants did not receive treatment in this quadrant.
11317345|NCT03257202|OG001|Outcome|Benzoyl Peroxide 5% Topical Gel|This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel
11317346|NCT03257202|OG002|Outcome|Clindamycin 1% Topical Gel|This quadrant of the participants' back received Clindamycin 1% topical gel
11317347|NCT03257202|OG003|Outcome|Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel|This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel
11317348|NCT03257202|EG000|Reported Event|Control|No topical treatment
11317349|NCT03257202|EG001|Reported Event|Clindamycin Alone|"topical clindamycin alone using Clindamycin 1% Gel~Clindamycin 1% Gel: topical clindamycin"
11317350|NCT03257202|EG002|Reported Event|Benzoyl Peroxide Alone|"topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel~Benzoyl peroxide 5% gel: topical benzoyl peroxide"
11317351|NCT03257202|EG003|Reported Event|Clindamycin and Benzoyl Peroxide|"Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel~BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together"
11317352|NCT03257358|BG000|Baseline|Cohort 1|RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
11317353|NCT03257358|BG001|Baseline|Cohort 2|RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
11317354|NCT03257358|BG002|Baseline|Total|Total of all reporting groups
11317355|NCT03257358|FG000|Participant Flow|Cohort 1|RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
11317356|NCT03257358|FG001|Participant Flow|Cohort 2|RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
11317357|NCT03257358|OG000|Outcome|Cohort 1|RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
11317358|NCT03257358|OG001|Outcome|Cohort 2|RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
11317359|NCT03257358|EG000|Reported Event|Cohort 1|RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
11317360|NCT03257358|EG001|Reported Event|Cohort 2|RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
11317361|NCT03257371|BG000|Baseline|Post-traumatic Knee OA|post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
11317362|NCT03257371|FG000|Participant Flow|Post-traumatic Knee OA|post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
11317363|NCT03257371|OG000|Outcome|Post-traumatic Knee OA|post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
11317364|NCT03257371|EG000|Reported Event|Post-traumatic Knee OA|post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
11317365|NCT03257410|BG000|Baseline|Theranova 400|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317366|NCT03257410|BG001|Baseline|Elisio-17H|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317367|NCT03257410|BG002|Baseline|Total|Total of all reporting groups
11317368|NCT03257410|FG000|Participant Flow|Theranova 400|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317369|NCT03257410|FG001|Participant Flow|Elisio-17H|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317370|NCT03257410|OG000|Outcome|Theranova 400|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317371|NCT03257410|OG001|Outcome|Elisio-17H|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317372|NCT03257410|EG000|Reported Event|Theranova 400|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317373|NCT03257410|EG001|Reported Event|Elisio-17H|"Three (3) dialysis sessions per week in an in-center setting over 24-week period.~Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study."
11317374|NCT03257657|BG000|Baseline|Observational Group|"Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.~Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time."
11317375|NCT03257657|BG001|Baseline|Lifestyle Group|"Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.~In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.~Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks."
11317376|NCT03257657|BG002|Baseline|Total|Total of all reporting groups
11317377|NCT03257657|FG000|Participant Flow|Observational Group|"Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.~Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time."
11317378|NCT03257657|FG001|Participant Flow|Lifestyle Group|"Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.~In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.~Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks."
11317379|NCT03257657|OG000|Outcome|Observational Group|"Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.~Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time."
11317380|NCT03257657|OG001|Outcome|Lifestyle Group|"Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.~In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.~Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks."
11317381|NCT03257657|OG000|Outcome|Lifestyle Group|"Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.~In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.~Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks."
11317382|NCT03257657|EG000|Reported Event|Observational Group|"Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.~Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time."
11317383|NCT03257657|EG001|Reported Event|Lifestyle Group|"Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.~In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.~Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks."
11317384|NCT03257813|BG000|Baseline|Group A|"In group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be retested and switched to a PRO-122 solution which will be used for 30 days until the 60th day, The final visit.~PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317385|NCT03257813|BG001|Baseline|Group B|"In group B, therapy with Krytantek Ofteno® will be suspended and changes for PRO-122 for 30 days, in which the subject will be retested and later switched to Krytantek Ofteno® solution which will be used for 30 days until the 60th day, The final visit.~PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317386|NCT03257813|BG002|Baseline|Total|Total of all reporting groups
11317387|NCT03257813|FG000|Participant Flow|Group A|"In group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be retested and switched to a PRO-122 solution which will be used for 30 days until the 60th day, The final visit.~PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317388|NCT03257813|FG001|Participant Flow|Group B|"In group B, therapy with Krytantek Ofteno® will be suspended and changes for PRO-122 for 30 days, in which the subject will be retested and later switched to Krytantek Ofteno® solution which will be used for 30 days until the 60th day, The final visit.~PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317389|NCT03257813|OG000|Outcome|Sequence A|"First Period: PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Second Period: Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317390|NCT03257813|OG001|Outcome|Sequence B|"First Period: Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Second Period: PRO-122: 1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317391|NCT03257813|OG001|Outcome|Sequence B|"First Period: Krytantek Ofteno®: 1 drop every 12 hours for 30 days of alternating treatment with 30 days~Second Period: _1 drop every 12 hours for 30 days of alternating treatment with 30 days"
11317392|NCT03257813|OG000|Outcome|PRO-122|all subjects who received at least one application of PRO-122 in both sequences
11317393|NCT03257813|OG001|Outcome|Krytantek Ofteno|all subjects who received at least one application of Krytantek Ofteno in both sequences
11317394|NCT03257813|EG000|Reported Event|PRO-122|"All adverse events that occurred with the product under investigation PRO-122 were collected regardless of the sequence in which they participated.~The 30 participants of both sequences received at least one dose of PRO-122, therefore 60 subjects exposed in this group are considered."
11317395|NCT03257813|EG001|Reported Event|Krytantek Ofteno®|"All adverse events that occurred with the product under investigation Krytantek Ofteno® were collected regardless of the sequence in which they participated.~The 30 participants of both sequences received at least one dose of Krytantek Ofteno®, therefore 60 subjects exposed in this group are considered."
11317396|NCT03257865|BG000|Baseline|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligram (mg)/day; titrated to a maximum of 4 mg/day.
11317397|NCT03257865|BG001|Baseline|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317398|NCT03257865|BG002|Baseline|Total|Total of all reporting groups
11317399|NCT03257865|FG000|Participant Flow|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligram (mg)/day; titrated to a maximum of 4 mg/day.
11317400|NCT03257865|FG001|Participant Flow|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317401|NCT03257865|OG000|Outcome|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligram (mg)/day; titrated to a maximum of 4 mg/day.
11317402|NCT03257865|OG001|Outcome|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317403|NCT03257865|EG000|Reported Event|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligram (mg)/day; titrated to a maximum of 4 mg/day.
11317404|NCT03257865|EG001|Reported Event|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317405|NCT03257995|BG000|Baseline|All Participants|All participants randomized to one of six treatment sequences
11317406|NCT03257995|FG000|Participant Flow|Sequence 1|indacaterol maleate 150 μg , indacaterol acetate 150 μg and matching placebo
11317407|NCT03257995|FG001|Participant Flow|Sequence 2|indacaterol acetate 150 μg, matching placebo and indacaterol maleate 150 μg
11317408|NCT03257995|FG002|Participant Flow|Sequence 3|Placebo, indacaterol maleate 150 μg and indacaterol acetate 150 μg
11317409|NCT03257995|FG003|Participant Flow|Sequence 4|indacaterol maleate 150 μg, placebo, and indacaterol acetate 150 μg
11317410|NCT03257995|FG004|Participant Flow|Sequence 5|indacaterol acetate 150 μg, indacaterol maleate 150 μg, and placebo
11317411|NCT03257995|FG005|Participant Flow|Sequence 6|Placebo, indacaterol acetate 150 μg, indacaterol maleate 150 μg
11317412|NCT03257995|OG000|Outcome|Indacaterol Maleate|indacaterol maleate 150 μg via Breezhaler
11317413|NCT03257995|OG001|Outcome|Indacaterol Acetate|indacaterol acetate 150 μg via Breezhaler
11317414|NCT03257995|OG002|Outcome|Placebo|matching placebo capsules to indacaterol via Breezhaler
11317415|NCT03257995|OG000|Outcome|Indacaterol Maleate 150 µg|indacaterol maleate 150 μg via Breezhaler
11317416|NCT03257995|OG001|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 μg via Breezhaler
11317417|NCT03257995|OG000|Outcome|Indacaterol Maleate / Indacaterol Acetate|Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) AUC0-24h,ss
11317418|NCT03257995|OG001|Outcome|Indacaterol Acetate 150 µg|Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) Cmax,ss
11317419|NCT03257995|EG000|Reported Event|Indacaterol Maleate 150 µg|indacaterol maleate 150 μg via Breezhaler
11317420|NCT03257995|EG001|Reported Event|Indacaterol Acetate 150 µg|indacaterol acetate 150 μg via Breezhaler
11317421|NCT03257995|EG002|Reported Event|Placebo|matching placebo capsules to indacaterol via Breezhaler
11335947|NCT03559062|EG002|Reported Event|Ivacaftor|Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks.
11317422|NCT03258645|BG000|Baseline|Total|Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.
11317423|NCT03258645|FG000|Participant Flow|Total|Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.
11317424|NCT03258645|OG000|Outcome|Total|Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.
11317425|NCT03258645|OG000|Outcome|0 - 24 Hours|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time less than 24 hours following index event were included in this group."
11317426|NCT03258645|OG001|Outcome|> 24 - 72 Hours|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group."
11317427|NCT03258645|OG002|Outcome|> 3 - 7 Days|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group."
11317428|NCT03258645|OG003|Outcome|> 7 - 14 Days|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group."
11317429|NCT03258645|OG004|Outcome|> 14 - 28 Days|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group."
11317430|NCT03258645|OG005|Outcome|> 28 Days - 3 Months|"Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.~Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group."
11317431|NCT03258645|EG000|Reported Event|Total|Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.
11317432|NCT03258710|BG000|Baseline|Tenofovir Disoproxil Fumarate|Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
10848562|NCT00290472|BG002|Baseline|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
11317433|NCT03258710|FG000|Participant Flow|Tenofovir Disoproxil Fumarate|Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
11317434|NCT03258710|OG000|Outcome|Tenofovir Disoproxil Fumarate|Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
11317435|NCT03258710|EG000|Reported Event|Tenofovir Disoproxil Fumarate|Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.
11317436|NCT03258762|BG000|Baseline|Healthy Japanese Participants|Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11335948|NCT03559179|BG000|Baseline|Waivered Providers Received the Opioid Wizard|"These providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11317437|NCT03258762|BG001|Baseline|Healthy Caucasian Participants|Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317438|NCT03258762|BG002|Baseline|Total|Total of all reporting groups
11317439|NCT03258762|FG000|Participant Flow|Healthy Japanese Participants|Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 milligram (mg) tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 milliliters (mL) of water.
11317440|NCT03258762|FG001|Participant Flow|Healthy Caucasian Participants|Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317441|NCT03258762|OG000|Outcome|Healthy Japanese Participants|Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317442|NCT03258762|OG000|Outcome|Healthy Caucasian Participants|Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317443|NCT03258762|OG001|Outcome|Healthy Caucasian Participants|Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317444|NCT03258762|EG000|Reported Event|Healthy Japanese Participants|Healthy Japanese male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317445|NCT03258762|EG001|Reported Event|Healthy Caucasian Participants|Healthy Caucasian male participants received a single oral dose of Pyrimethamine 50 mg tablet in the fasted state co-administered with calcium folinate 15 mg tablet on Day 1. Oral calcium folinate was administered once daily until Day 8 along with 240 mL of water.
11317446|NCT03258814|BG000|Baseline|Active Supervised Training (AST)|Participants were to receive active supervised and standardized training (AST).
11317447|NCT03258814|BG001|Baseline|Standard of Care (SOC) Physiotherapy|Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
11317448|NCT03258814|BG002|Baseline|Total|Total of all reporting groups
11317449|NCT03258814|FG000|Participant Flow|Active Supervised Training (AST)|Participants were to receive active supervised and standardized training (AST).
11317450|NCT03258814|FG001|Participant Flow|Standard of Care (SOC) Physiotherapy|Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
11317451|NCT03258814|FG002|Participant Flow|Not Randomized|Participants who were enrolled in the study but were not randomized.
11317452|NCT03258814|OG000|Outcome|Active Supervised Training (AST)|Participants were to receive active supervised and standardized training (AST).
11317453|NCT03258814|OG001|Outcome|Standard of Care (SOC) Physiotherapy|Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
11317454|NCT03258814|EG000|Reported Event|Active Supervised Training (AST)|Participants were to receive active supervised and standardized training (AST).
11317455|NCT03258814|EG001|Reported Event|Standard of Care (SOC) Physiotherapy|Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
10848563|NCT00290472|BG003|Baseline|Total|Total of all reporting groups
11317456|NCT03258814|EG002|Reported Event|Not Randomized|Participants who were enrolled in the study but were not randomized.
11317457|NCT03259087|BG000|Baseline|Part 1: Mild Renal Impairment (RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317458|NCT03259087|BG001|Baseline|Part 1: Moderate Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317459|NCT03259087|BG002|Baseline|Part 1: Severe Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317460|NCT03259087|BG003|Baseline|Part 1: Healthy Participants|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317461|NCT03259087|BG004|Baseline|Part 2: End-stage Renal Disease Undergoing Hemodialysis|End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317462|NCT03259087|BG005|Baseline|Total|Total of all reporting groups
11317463|NCT03259087|FG000|Participant Flow|Part 1: Mild Renal Impairment (RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317464|NCT03259087|FG001|Participant Flow|Part 1: Moderate Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317465|NCT03259087|FG002|Participant Flow|Part 1: Severe Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317466|NCT03259087|FG003|Participant Flow|Part 1: Healthy Participants|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317467|NCT03259087|FG004|Participant Flow|Part 2: End-stage Renal Disease Undergoing Hemodialysis|End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317468|NCT03259087|OG000|Outcome|Part 1: Mild Renal Impairment (RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317469|NCT03259087|OG001|Outcome|Part 1: Moderate Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317470|NCT03259087|OG002|Outcome|Part 1: Healthy Participants (Mild + Moderate RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
11317471|NCT03259087|OG003|Outcome|Part 1: Severe Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317472|NCT03259087|OG004|Outcome|Part 1: Healthy Participants (Severe RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
11317473|NCT03259087|OG002|Outcome|Part 1: Severe Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317474|NCT03259087|OG003|Outcome|Part 1: Healthy Participants (Mild, Moderate, and Severe RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the mild, moderate, and severe groups.
11317475|NCT03259087|OG000|Outcome|Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2.
11317476|NCT03259087|OG001|Outcome|Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317477|NCT03259087|OG002|Outcome|Part 1: Healthy Participants (ESRD)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the ESRD group.
11317478|NCT03259087|OG000|Outcome|Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317479|NCT03259087|OG003|Outcome|Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2.
11317480|NCT03259087|OG004|Outcome|Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317481|NCT03259087|OG005|Outcome|Part 1: Healthy Participants|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
11317482|NCT03259087|EG000|Reported Event|Part 1: Mild Renal Impairment (RI)|Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317483|NCT03259087|EG001|Reported Event|Part 1: Moderate Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317484|NCT03259087|EG002|Reported Event|Part 1: Severe Renal Impairment|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
11317485|NCT03259087|EG003|Reported Event|Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2.
11317486|NCT03259087|EG004|Reported Event|Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
11317487|NCT03259087|EG005|Reported Event|Part 1: Healthy Participants|Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender, and mean age and BMI of the comparator groups.
11317488|NCT03259139|BG000|Baseline|Experimental: Violence With Guns (Player)|"Participants in this condition will play a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317489|NCT03259139|BG001|Baseline|Experimental: Violence With Guns (Watcher)|"Participants in this condition will watch a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317490|NCT03259139|BG002|Baseline|Experimental: Violence Without Guns (Player)|"Participants in this condition will play a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317491|NCT03259139|BG003|Baseline|Experimental: Violence Without Guns (Watcher)|"Participants in this condition will watch a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317492|NCT03259139|BG004|Baseline|Control: No Violence (Player)|"Participants in this condition will play a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317493|NCT03259139|BG005|Baseline|Control: No Violence (Watcher)|"Participants in this condition will watch a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317494|NCT03259139|BG006|Baseline|Total|Total of all reporting groups
11317495|NCT03259139|FG000|Participant Flow|Experimental: Violence With Guns (Player)|"Participants in this condition will play a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317496|NCT03259139|FG001|Participant Flow|Experimental: Violence With Guns (Watcher)|"Participants in this condition will watch a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317497|NCT03259139|FG002|Participant Flow|Experimental: Violence Without Guns (Player)|"Participants in this condition will play a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317498|NCT03259139|FG003|Participant Flow|Experimental: Violence Without Guns (Watcher)|"Participants in this condition will watch a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317499|NCT03259139|FG004|Participant Flow|Control: No Violence (Player)|"Participants in this condition will play a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317500|NCT03259139|FG005|Participant Flow|Control: No Violence (Watcher)|"Participants in this condition will watch a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317501|NCT03259139|OG000|Outcome|Control: No Violence (Player)|"Participants in this condition will play a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317502|NCT03259139|OG001|Outcome|Control: No Violence (Watcher)|"Participants in this condition will watch a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317503|NCT03259139|OG002|Outcome|Experimental: Violence Without Guns (Player)|"Participants in this condition will play a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317504|NCT03259139|OG003|Outcome|Experimental: Violence Without Guns (Watcher)|"Participants in this condition will watch a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317505|NCT03259139|OG004|Outcome|Experimental: Violence With Guns (Player)|"Participants in this condition will play a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317506|NCT03259139|OG005|Outcome|Experimental: Violence With Guns (Watcher)|"Participants in this condition will watch a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317507|NCT03259139|OG000|Outcome|Control: No Violence|"Participants in this condition will play a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317508|NCT03259139|OG002|Outcome|Experimental: Violence Without Guns|"Participants in this condition will play a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317509|NCT03259139|OG004|Outcome|Experimental: Violence With Guns|"Participants in this condition will play a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
10827636|NCT00110994|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317510|NCT03259139|EG000|Reported Event|Experimental: Violence With Guns (Player)|"Participants in this condition will play a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317511|NCT03259139|EG001|Reported Event|Experimental: Violence With Guns (Watcher)|"Participants in this condition will watch a video game with violent content which includes guns.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317512|NCT03259139|EG002|Reported Event|Experimental: Violence Without Guns (Player)|"Participants in this condition will play a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317513|NCT03259139|EG003|Reported Event|Experimental: Violence Without Guns (Watcher)|"Participants in this condition will watch a video game with violent content which does not include guns. Instead, the violence will include weapons such as swords.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317514|NCT03259139|EG004|Reported Event|Control: No Violence (Player)|"Participants in this condition will play a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317515|NCT03259139|EG005|Reported Event|Control: No Violence (Watcher)|"Participants in this condition will watch a video game which contains no violent content or weapons.~Video games and violence: Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition."
11317516|NCT03259308|BG000|Baseline|Placebo|Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317517|NCT03259308|BG001|Baseline|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317518|NCT03259308|BG002|Baseline|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317519|NCT03259308|BG003|Baseline|Total|Total of all reporting groups
11317520|NCT03259308|FG000|Participant Flow|Placebo|Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317521|NCT03259308|FG001|Participant Flow|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317522|NCT03259308|FG002|Participant Flow|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317523|NCT03259308|OG000|Outcome|Placebo|Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317524|NCT03259308|OG001|Outcome|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317525|NCT03259308|OG002|Outcome|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317526|NCT03259308|EG000|Reported Event|Placebo|Participants received placebo matched to ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8.
11317527|NCT03259308|EG001|Reported Event|Ontamalimab 25 mg|Participants received 25 milligram (mg) of ontamalimab SC injection using a PFS on Week 0, Week 4 and Week 8.
11317528|NCT03259308|EG002|Reported Event|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.
11317529|NCT03259334|BG000|Baseline|Placebo|Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317530|NCT03259334|BG001|Baseline|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317531|NCT03259334|BG002|Baseline|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317532|NCT03259334|BG003|Baseline|Total|Total of all reporting groups
11317533|NCT03259334|FG000|Participant Flow|Placebo|Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317534|NCT03259334|FG001|Participant Flow|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317535|NCT03259334|FG002|Participant Flow|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317536|NCT03259334|OG000|Outcome|Placebo|Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317537|NCT03259334|OG001|Outcome|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317538|NCT03259334|OG002|Outcome|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317539|NCT03259334|EG000|Reported Event|Placebo|Participants received placebo matched to ontamalimab (SHP647) subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
11317540|NCT03259334|EG001|Reported Event|Ontamalimab 25 mg|Participants received 25 milligrams (mg) of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317541|NCT03259334|EG002|Reported Event|Ontamalimab 75 mg|Participants received 75 mg of ontamalimab (SHP647) SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
11317542|NCT03259490|BG000|Baseline|Test/ Reference (TR)|Subjects were orally administered a single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered the free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast.
11317543|NCT03259490|BG001|Baseline|Reference/ Test (RT)|Subjects were orally administered the free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered a single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast.
11317544|NCT03259490|BG002|Baseline|Total|Total of all reporting groups
11317545|NCT03259490|FG000|Participant Flow|Test/ Reference (TR)|Subjects were orally administered a single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered the free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast.
11317546|NCT03259490|FG001|Participant Flow|Reference/ Test (RT)|Subjects were orally administered the free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered a single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast.
11317547|NCT03259490|OG000|Outcome|Empagliflozin/Linagliptin/Metformin FDC (Test)|Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11317548|NCT03259490|OG001|Outcome|Empagliflozin/Linagliptin/Metformin FC (Reference)|Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast
11317549|NCT03259490|EG000|Reported Event|Empagliflozin/Linagliptin/Metformin FDC (Test)|Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
11317550|NCT03259490|EG001|Reported Event|Empagliflozin/Linagliptin/Metformin FC (Reference)|Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast
11317551|NCT03259555|BG000|Baseline|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligrams (mg)/day; titrated to a maximum of 4 mg/day.
11317552|NCT03259555|BG001|Baseline|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317553|NCT03259555|BG002|Baseline|Total|Total of all reporting groups
11317554|NCT03259555|FG000|Participant Flow|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligrams (mg)/day; titrated to a maximum of 4 mg/day.
11317555|NCT03259555|FG001|Participant Flow|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
10827637|NCT00110994|EG001|Reported Event|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317556|NCT03259555|OG000|Outcome|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligrams (mg)/day; titrated to a maximum of 4 mg/day.
11317557|NCT03259555|OG001|Outcome|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317558|NCT03259555|EG000|Reported Event|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 milligrams (mg)/day; titrated to a maximum of 4 mg/day.
11317559|NCT03259555|EG001|Reported Event|Placebo|Matching placebo was administered orally in the same way as brexpiprazole to maintain the blind.
11317560|NCT03259789|BG000|Baseline|Double-blind Group: Bexagliflozin 20 mg|Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317561|NCT03259789|BG001|Baseline|Double-blind Group: Placebo|Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317562|NCT03259789|BG002|Baseline|High Glycemic Group|Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317563|NCT03259789|BG003|Baseline|Total|Total of all reporting groups
11317564|NCT03259789|FG000|Participant Flow|Double-blind Group: Bexagliflozin 20 mg|Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317565|NCT03259789|FG001|Participant Flow|Double-blind Group: Placebo|Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317566|NCT03259789|FG002|Participant Flow|High Glycemic Group|Each subject will receive Bexagliflozin tablet, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317567|NCT03259789|OG000|Outcome|Double-blind Group: Bexagliflozin 20 mg|Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317568|NCT03259789|OG001|Outcome|Double-blind Group: Placebo|Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317569|NCT03259789|OG000|Outcome|High Glycemic Group|Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317570|NCT03259789|OG002|Outcome|High Glycemic Group|Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317571|NCT03259789|EG000|Reported Event|Double-blind Group: Bexagliflozin 20 mg|Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317572|NCT03259789|EG001|Reported Event|Double-blind Group: Placebo|Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317573|NCT03259789|EG002|Reported Event|High Glycemic Group|Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.
11317574|NCT03260205|BG000|Baseline|Placebo|Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.
11317575|NCT03260205|BG001|Baseline|SPD489 5 mg|Participants received SPD489 5 mg capsule orally once daily for 6 weeks.
11317576|NCT03260205|BG002|Baseline|SPD489 10 mg|Participants received SPD489 10 mg capsule orally once daily for 6 weeks.
11317577|NCT03260205|BG003|Baseline|SPD489 20 mg|Participants received SPD489 20 mg capsule orally once daily for 6 weeks.
11317578|NCT03260205|BG004|Baseline|SPD489 30 mg|Participants received SPD489 30 mg capsule orally once daily for 6 weeks.
11317579|NCT03260205|BG005|Baseline|Total|Total of all reporting groups
11317580|NCT03260205|FG000|Participant Flow|Placebo|Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.
11317581|NCT03260205|FG001|Participant Flow|SPD489 5 mg|Participants received SPD489 5 mg capsule orally once daily for 6 weeks.
11317582|NCT03260205|FG002|Participant Flow|SPD489 10 mg|Participants received SPD489 10 mg capsule orally once daily for 6 weeks.
11317583|NCT03260205|FG003|Participant Flow|SPD489 20 mg|Participants received SPD489 20 mg capsule orally once daily for 6 weeks.
11317584|NCT03260205|FG004|Participant Flow|SPD489 30 mg|Participants received SPD489 30 mg capsule orally once daily for 6 weeks.
11317585|NCT03260205|OG000|Outcome|Placebo|Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.
11317586|NCT03260205|OG001|Outcome|Pooled SPD489 Doses (10, 20, and 30 mg)|Participants received SPD489 10, 20, and 30 mg capsule orally once daily for 6 weeks were pooled.
11317587|NCT03260205|OG001|Outcome|SPD489 30 mg|Participants received fixed dose of SPD489 30 mg capsule orally once daily for 6 weeks.
11317588|NCT03260205|OG002|Outcome|SPD489 20 mg|Participants received fixed dose of SPD489 20 mg capsule orally once daily for 6 weeks.
11317589|NCT03260205|OG003|Outcome|SPD489 10 mg|Participants received fixed dose of SPD489 10 mg capsule orally once daily for 6 weeks.
11317590|NCT03260205|OG004|Outcome|SPD489 5 mg|Participants received fixed dose of SPD489 5 mg capsule orally once daily for 6 weeks.
11317591|NCT03260205|OG001|Outcome|SPD489 5 mg|Participants received SPD489 5 mg capsule orally once daily for 6 weeks.
11317592|NCT03260205|OG002|Outcome|SPD489 10 mg|Participants received SPD489 10 mg capsule orally once daily for 6 weeks.
11317593|NCT03260205|OG003|Outcome|SPD489 20 mg|Participants received SPD489 20 mg capsule orally once daily for 6 weeks.
11317594|NCT03260205|OG004|Outcome|SPD489 30 mg|Participants received SPD489 30 mg capsule orally once daily for 6 weeks.
11317595|NCT03260205|EG000|Reported Event|Placebo|Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.
11317596|NCT03260205|EG001|Reported Event|SPD489 5 mg|Participants received SPD489 capsule orally at a dose of 5 milligram (mg) once daily for 6 weeks.
11317597|NCT03260205|EG002|Reported Event|SPD489 10 mg|Participants received SPD489 capsule orally at a dose of 10 mg once daily for 6 weeks.
11317598|NCT03260205|EG003|Reported Event|SPD489 20 mg|Participants received SPD489 capsule orally at a dose of 20 mg once daily for 6 weeks.
11317599|NCT03260205|EG004|Reported Event|SPD489 30 mg|Participants received SPD489 capsule orally at a dose of 30 mg once daily for 6 weeks.
11317600|NCT03260426|BG000|Baseline|Clear Liquid Diet|"Clear liquids on postoperative day zero and intestinal rate measured by Abstats~Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317601|NCT03260426|BG001|Baseline|Regular Solid Diet|"Regular diet from postoperative day zero and intestinal rate measured by Abstats~Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317602|NCT03260426|BG002|Baseline|Total|Total of all reporting groups
11317603|NCT03260426|FG000|Participant Flow|Clear Liquid Diet|"Clear liquids on postoperative day zero and intestinal rate measured by Abstats~Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317604|NCT03260426|FG001|Participant Flow|Regular Solid Diet|"Regular diet from postoperative day zero and intestinal rate measured by Abstats~Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317605|NCT03260426|OG000|Outcome|Clear Liquid Diet|"Clear liquids on postoperative day zero and intestinal rate measured by Abstats~Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317606|NCT03260426|OG001|Outcome|Regular Solid Diet|"Regular diet from postoperative day zero and intestinal rate measured by Abstats~Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317607|NCT03260426|EG000|Reported Event|Clear Liquid Diet|"Clear liquids on postoperative day zero and intestinal rate measured by Abstats~Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317608|NCT03260426|EG001|Reported Event|Regular Solid Diet|"Regular diet from postoperative day zero and intestinal rate measured by Abstats~Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards~Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery"
11317609|NCT03260595|BG000|Baseline|Cohort 1: Crisaborole Ointment 2% and Vehicle|Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
11317610|NCT03260595|BG001|Baseline|Cohort 2: Crisaborole Ointment 2%|Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317611|NCT03260595|BG002|Baseline|Cohort 2: Vehicle|Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317612|NCT03260595|BG003|Baseline|Total|Total of all reporting groups
11317613|NCT03260595|FG000|Participant Flow|Cohort 1: Crisaborole Ointment 2% and Vehicle|Crisaborole ointment 2 percent (%) and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
11317614|NCT03260595|FG001|Participant Flow|Cohort 2: Crisaborole Ointment 2%|Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is atopic dermatitis [AD]-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317615|NCT03260595|FG002|Participant Flow|Cohort 2: Vehicle|Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317616|NCT03260595|OG000|Outcome|Cohort 1: Crisaborole Ointment 2% and Vehicle|Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
11317617|NCT03260595|OG000|Outcome|Cohort 2: Crisaborole Ointment 2%|Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317618|NCT03260595|OG001|Outcome|Cohort 2: Vehicle|Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
10827638|NCT00111007|BG000|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317619|NCT03260595|EG000|Reported Event|Cohort 1: Crisaborole Ointment 2% and Vehicle|Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
11317620|NCT03260595|EG001|Reported Event|Cohort 2: Crisaborole Ointment 2%|Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317621|NCT03260595|EG002|Reported Event|Cohort 2: Vehicle|Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
11317622|NCT03260699|BG000|Baseline|Control Group|Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
11317623|NCT03260699|BG001|Baseline|Bracing Group|"Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.~OCSI Rehabilitator brace: Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear."
11317624|NCT03260699|BG002|Baseline|Total|Total of all reporting groups
11317625|NCT03260699|FG000|Participant Flow|Control Group|Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
11317626|NCT03260699|FG001|Participant Flow|Bracing Group|"Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.~OCSI Rehabilitator brace: Guardian Brace features the new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function."
11317627|NCT03260699|OG000|Outcome|Control Group|Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
11317628|NCT03260699|OG001|Outcome|Bracing Group|"Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.~OCSI Rehabilitator brace: Guardian Brace features the new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function."
11317629|NCT03260699|EG000|Reported Event|Control Group|Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
11317630|NCT03260699|EG001|Reported Event|Bracing Group|"Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.~OCSI Rehabilitator brace: Guardian Brace features the new Rehabilitator™ line of gait correcting, leg strengthening braces. It is hypothesized that this brace may help reduce pain and improve knee function."
11317631|NCT03260790|BG000|Baseline|PCV13 and PPSV23|"Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23~PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection~PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously"
11317632|NCT03260790|BG001|Baseline|PPSV23|"Participants received PPSV23 alone~PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously"
11317633|NCT03260790|BG002|Baseline|Total|Total of all reporting groups
11317634|NCT03260790|FG000|Participant Flow|PCV13 and PPSV23|"Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23~PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection~PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously"
11317635|NCT03260790|FG001|Participant Flow|PPSV23|"Participants received PPSV23 alone~PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously"
11317636|NCT03260790|OG000|Outcome|PCV13 and PPSV23|"Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23~PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection~PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously"
11317637|NCT03260790|OG001|Outcome|PPSV23|"Participants received PPSV23 alone~PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously"
11317638|NCT03260790|EG000|Reported Event|PCV13 and PPSV23|"Participants received PPSV23 primed with PCV13~PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection~PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously"
11317639|NCT03260790|EG001|Reported Event|PPSV23|"Participants received PPSV23 alone~PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously"
11317640|NCT03261037|BG000|Baseline|IPF Participants|Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
11317641|NCT03261037|BG001|Baseline|Non-IPF ILD Participants|Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
11317642|NCT03261037|BG002|Baseline|Non-ILD Participants|Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
11317643|NCT03261037|BG003|Baseline|Participants Without Diagnosis|Participants without diagnosis
11317644|NCT03261037|BG004|Baseline|Total|Total of all reporting groups
11317645|NCT03261037|FG000|Participant Flow|IPF Participants|Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
11317646|NCT03261037|FG001|Participant Flow|Non-IPF ILD Participants|Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
11317647|NCT03261037|FG002|Participant Flow|Non-ILD Participants|Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
11317648|NCT03261037|FG003|Participant Flow|Participants Without Diagnosis|Participants without diagnosis
11317649|NCT03261037|OG000|Outcome|IPF Participants|Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
11317650|NCT03261037|OG000|Outcome|Non-IPF ILD Participants|Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
11317651|NCT03261037|OG001|Outcome|Non-IPF ILD Participants|Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
11317652|NCT03261037|OG002|Outcome|Non-ILD Participants|Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
11317653|NCT03261037|OG003|Outcome|Participants Without Diagnosis|Participants without diagnosis
11317654|NCT03261037|EG000|Reported Event|IPF Participants|Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
11317655|NCT03261037|EG001|Reported Event|Participants With and an ILD Other Than IPF (Non-IPF ILD)|Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
11317656|NCT03261037|EG002|Reported Event|Non-ILD Participants|Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
11317657|NCT03261037|EG003|Reported Event|Participants Without Diagnosis|Participants without diagnosis
11317658|NCT03261167|BG000|Baseline|GSK1358820 240 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11317659|NCT03261167|BG001|Baseline|GSK1358820 400 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11317660|NCT03261167|BG002|Baseline|Total|Total of all reporting groups
11317661|NCT03261167|FG000|Participant Flow|GSK1358820 240 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11317662|NCT03261167|FG001|Participant Flow|GSK1358820 400 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11317663|NCT03261167|OG000|Outcome|GSK1358820 240 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11335949|NCT03559179|BG001|Baseline|Non-Waivered Providers Who Received the Opioid Wizard|"Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents non-waivered providers who received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11335950|NCT03559179|BG002|Baseline|Non-Waivered Providers Who do Not Receive the Opioid Wizard|These are non-buprenorphine waivered providers continued to treat their patients as usual.
11335951|NCT03559179|BG003|Baseline|Total|Total of all reporting groups
11317664|NCT03261167|OG001|Outcome|GSK1358820 400 U|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
11317665|NCT03261167|EG000|Reported Event|GSK1358820 240 U (Double Blind-Treatment Cycle 1)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.
11317666|NCT03261167|EG001|Reported Event|GSK1358820 400 U (Double Blind-Treatment Cycle 1)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.
11317667|NCT03261167|EG002|Reported Event|GSK1358820 240 U (Open Label-Treatment Cycle 2)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).
11317668|NCT03261167|EG003|Reported Event|GSK1358820 400 U (Open labelTreatment Cycle 2)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).
11317669|NCT03261167|EG004|Reported Event|GSK1358820 240 U (Open Label-Treatment Cycle 3)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments.
11317670|NCT03261167|EG005|Reported Event|GSK1358820 400 U (Open Label-Treatment Cycle 3)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments.
11317671|NCT03261167|EG006|Reported Event|GSK1358820 240 U (Open Label-Treatment Cycle 4)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
11317672|NCT03261167|EG007|Reported Event|GSK1358820 400 U (Open Label-Treatment Cycle 4)|Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
11317673|NCT03261336|BG000|Baseline|Calcitriol, Ketoconazole, Hydrocortisone|"Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).~Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol"
11317674|NCT03261336|FG000|Participant Flow|Calcitriol, Ketoconazole, Hydrocortisone|"Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).~Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol"
11317675|NCT03261336|OG000|Outcome|Calcitriol, Ketoconazole, Hydrocortisone|"Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).~Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol"
11317676|NCT03261336|EG000|Reported Event|Calcitriol, Ketoconazole, Hydrocortisone|"Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).~Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol"
11317677|NCT03261947|BG000|Baseline|Western Safety Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
11335952|NCT03559179|FG000|Participant Flow|Waivered Providers Received the Opioid Wizard|"All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11317678|NCT03261947|BG001|Baseline|Pancreatic Cancer Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317679|NCT03261947|BG002|Baseline|Metastatic CRC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
11317680|NCT03261947|BG003|Baseline|sqEC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317681|NCT03261947|BG004|Baseline|sqNSCLC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
11317682|NCT03261947|BG005|Baseline|Total|Total of all reporting groups
11317683|NCT03261947|FG000|Participant Flow|Western Safety Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
11317684|NCT03261947|FG001|Participant Flow|Pancreatic Cancer Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317685|NCT03261947|FG002|Participant Flow|Metastatic CRC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
11317686|NCT03261947|FG003|Participant Flow|sqEC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317687|NCT03261947|FG004|Participant Flow|sqNSCLC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
11317688|NCT03261947|OG000|Outcome|Western Safety Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
11317689|NCT03261947|OG000|Outcome|Pancreatic Cancer Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317690|NCT03261947|OG001|Outcome|Metastatic CRC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
11317691|NCT03261947|OG002|Outcome|sqEC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317692|NCT03261947|OG003|Outcome|sqNSCLC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
11317693|NCT03261947|OG001|Outcome|Pancreatic Cancer Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317694|NCT03261947|OG002|Outcome|Metastatic CRC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
11317695|NCT03261947|OG003|Outcome|sqEC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317696|NCT03261947|OG004|Outcome|sqNSCLC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
11317697|NCT03261947|EG000|Reported Event|Western Safety Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
11317698|NCT03261947|EG001|Reported Event|Pancreatic Cancer Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317699|NCT03261947|EG002|Reported Event|Metastatic CRC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
11317700|NCT03261947|EG003|Reported Event|sqEC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
11317701|NCT03261947|EG004|Reported Event|sqNSCLC Cohort|TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
10827639|NCT00111007|BG001|Baseline|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317702|NCT03261960|BG000|Baseline|Experimental Arm|"BLI4700 Bowel Preparation~BLI4700: Oral bowel preparation"
11317703|NCT03261960|BG001|Baseline|Control Arm|"FDA Approved Bowel Preparation~Magnesium bowel preparation: Oral bowel preparation"
11317704|NCT03261960|BG002|Baseline|Total|Total of all reporting groups
11317705|NCT03261960|FG000|Participant Flow|Experimental Arm|"BLI4700 Bowel Preparation~BLI4700: Oral bowel preparation"
11317706|NCT03261960|FG001|Participant Flow|Control Arm|"FDA Approved Bowel Preparation~Magnesium bowel preparation: Oral bowel preparation"
11317707|NCT03261960|OG000|Outcome|Experimental Arm|"BLI4700 Bowel Preparation~BLI4700: Oral bowel preparation"
11317708|NCT03261960|OG001|Outcome|Control Arm|"FDA Approved Bowel Preparation~Magnesium bowel preparation: Oral bowel preparation"
11317709|NCT03261960|EG000|Reported Event|Experimental Arm|"BLI4700 Bowel Preparation~BLI4700: Oral bowel preparation"
11317710|NCT03261960|EG001|Reported Event|Control Arm|"FDA Approved Bowel Preparation~Magnesium bowel preparation: Oral bowel preparation"
11317711|NCT03261973|BG000|Baseline|DV8 Esophageal Deviation Tool|"This is a non-randomized one arm study.~Arm: usage of the DV8 esophageal deviation tool during the ablation procedure"
11317712|NCT03261973|FG000|Participant Flow|DV8 Esophageal Deviation Tool|"This is a non-randomized one arm study.~Arm: usage of the DV8 esophageal deviation tool during the ablation procedure"
11317713|NCT03261973|OG000|Outcome|DV8 Esophageal Deviation Tool|"This is a non-randomized one arm study.~Arm: usage of the DV8 esophageal deviation tool during the ablation procedure"
11317714|NCT03261973|EG000|Reported Event|DV8 Esophageal Deviation Tool|"This is a non-randomized one arm study.~Arm: usage of the DV8 esophageal deviation tool during the ablation procedure"
11317715|NCT03261999|BG000|Baseline|Leuprolide Mesylate 25mg|"Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.~The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.~Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate"
11317716|NCT03261999|FG000|Participant Flow|Leuprolide Mesylate 25mg|"Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.~The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.~Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate"
11317717|NCT03261999|OG000|Outcome|Leuprolide Mesylate 25mg|"Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.~The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.~Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate"
11317718|NCT03261999|EG000|Reported Event|Leuprolide Mesylate 25mg|"Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.~The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168.~Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate"
11317719|NCT03262012|BG000|Baseline|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11317720|NCT03262012|BG001|Baseline|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11317721|NCT03262012|BG002|Baseline|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11317722|NCT03262012|BG003|Baseline|Symbicort TBH 400/12 ug BID|Open Label Symbicort Turbuhaler 400/12 ug BID
11317723|NCT03262012|BG004|Baseline|Total|Total of all reporting groups
10827640|NCT00111007|BG002|Baseline|Total|Total of all reporting groups
10827641|NCT00111007|FG000|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317724|NCT03262012|FG000|Participant Flow|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11317725|NCT03262012|FG001|Participant Flow|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11317726|NCT03262012|FG002|Participant Flow|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11317727|NCT03262012|FG003|Participant Flow|Symbicort TBH 400/12 ug BID|Open Label Symbicort Turbuhaler 400/12 ug BID
11317728|NCT03262012|OG000|Outcome|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11317729|NCT03262012|OG001|Outcome|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11317730|NCT03262012|OG002|Outcome|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11317731|NCT03262012|OG003|Outcome|Symbicort TBH 400/12 ug|Open Label Symbicort Turbuhaler 400/12 ug BID
11317732|NCT03262012|EG000|Reported Event|BGF MDI 320/14.4/9.6 ug|Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
11317733|NCT03262012|EG001|Reported Event|GFF MDI 14.4/9.6 ug|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
11317734|NCT03262012|EG002|Reported Event|BFF MDI 320/9.6 ug|Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
11317735|NCT03262012|EG003|Reported Event|Symbicort TBH 400/12 ug BID|Open Label Symbicort Turbuhaler 400/12 ug BID
11317736|NCT03262038|BG000|Baseline|Ondansetron IV|"Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)~Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively."
11317737|NCT03262038|BG001|Baseline|Placebo|"Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)~Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively."
11317738|NCT03262038|BG002|Baseline|Total|Total of all reporting groups
11317739|NCT03262038|FG000|Participant Flow|Ondansetron IV|"Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)~Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively."
11317740|NCT03262038|FG001|Participant Flow|Placebo|"Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)~Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively."
11317741|NCT03262038|OG000|Outcome|Ondansetron IV|"Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)~Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively."
11317742|NCT03262038|OG001|Outcome|Placebo|"Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)~Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively."
11317743|NCT03262038|EG000|Reported Event|Ondansetron IV|"Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)~Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively."
11317744|NCT03262038|EG001|Reported Event|Placebo|"Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)~Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively."
11317745|NCT03262233|BG000|Baseline|Active Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317746|NCT03262233|BG001|Baseline|Active Non-Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317747|NCT03262233|BG002|Baseline|Placebo Deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317748|NCT03262233|BG003|Baseline|Placebo Non-Deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317749|NCT03262233|BG004|Baseline|Total|Total of all reporting groups
11317750|NCT03262233|FG000|Participant Flow|Active Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317751|NCT03262233|FG001|Participant Flow|Active Non-Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317752|NCT03262233|FG002|Participant Flow|Placebo Deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317753|NCT03262233|FG003|Participant Flow|Placebo Non-deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317754|NCT03262233|OG000|Outcome|Active Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
10827642|NCT00111007|FG001|Participant Flow|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317755|NCT03262233|OG001|Outcome|Active Non-deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317756|NCT03262233|OG002|Outcome|Placebo Deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317757|NCT03262233|OG003|Outcome|Placebo Non-deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317758|NCT03262233|OG001|Outcome|Active Non-Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317759|NCT03262233|EG000|Reported Event|Active Deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317760|NCT03262233|EG001|Reported Event|Active Non-deprived|"21 mg nicotine patches and 2 mg nicotine lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317761|NCT03262233|EG002|Reported Event|Placebo Deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place 24 hours after start of quit attempt"
11317762|NCT03262233|EG003|Reported Event|Placebo Non-deprived|"Placebo patches and placebo lozenges~+ First NPU task takes place during normal smoking prior to quit attempt"
11317763|NCT03262389|BG000|Baseline|Multiple Myeloma (MM) Patients|"New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.~Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).~Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq)."
11317764|NCT03262389|FG000|Participant Flow|Multiple Myeloma (MM) Patients|"New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.~Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).~Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq)."
11317765|NCT03262389|OG000|Outcome|Multiple Myeloma (MM) Patients|"New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.~Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).~Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq)."
11317766|NCT03262389|EG000|Reported Event|Multiple Myeloma (MM) Patients|"New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.~Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).~Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq)."
11317767|NCT03262441|BG000|Baseline|Mycophenolate Mofetil|"Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months~Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months"
11317768|NCT03262441|FG000|Participant Flow|Mycophenolate Mofetil|"Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months~Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months"
11335953|NCT03559179|FG001|Participant Flow|Non-Waivered Providers Received The Opioid Wizard|Non-buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
11317769|NCT03262441|OG000|Outcome|Mycophenolate Mofetil|"Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months~Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months"
11317770|NCT03262441|EG000|Reported Event|Mycophenolate Mofetil|"Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months~Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months"
11317771|NCT03263442|BG000|Baseline|Intervention|"Thiamine 200 mg IV~Thiamine: 200 mg IV three times daily for seven days"
11317772|NCT03263442|BG001|Baseline|Control|"Normal saline IV~Normal saline: Normal saline IV three times daily for seven days"
11317773|NCT03263442|BG002|Baseline|Total|Total of all reporting groups
11317774|NCT03263442|FG000|Participant Flow|Intervention|"Thiamine 200 mg IV~Thiamine: 200 mg IV three times daily for seven days"
11317775|NCT03263442|FG001|Participant Flow|Control|"Normal saline IV~Normal saline: Normal saline IV three times daily for seven days"
11317776|NCT03263442|OG000|Outcome|Intervention|"Thiamine 200 mg IV~Thiamine: 200 mg IV three times daily for seven days"
11317777|NCT03263442|OG001|Outcome|Control|"Normal saline IV~Normal saline: Normal saline IV three times daily for seven days"
11317778|NCT03263442|OG000|Outcome|Delirium|Participants who experienced delirium, defined as at least one DRS score >12, during the post-transplant hospitalization.
10848564|NCT00290472|FG000|Participant Flow|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
11317779|NCT03263442|OG001|Outcome|No Delirium|Participants who did not meet criteria for delirium during the post-transplant hospitalization.
11317780|NCT03263442|EG000|Reported Event|Intervention|"Thiamine 200 mg IV~Thiamine: 200 mg IV three times daily for seven days"
11317781|NCT03263442|EG001|Reported Event|Control|"Normal saline IV~Normal saline: Normal saline IV three times daily for seven days"
11317782|NCT03263702|BG000|Baseline|De Novo|Participants with 1st procedure
11317783|NCT03263702|BG001|Baseline|Re-Do Ablation|Participants who need a re-do ablation procedure
11317784|NCT03263702|BG002|Baseline|Total|Total of all reporting groups
11317785|NCT03263702|FG000|Participant Flow|De Novo|Participants with 1st procedure
11317786|NCT03263702|FG001|Participant Flow|Re-Do Ablation|Participants who need a re-do ablation procedure
11317787|NCT03263702|OG000|Outcome|De Novo|Participants with 1st procedure
11317788|NCT03263702|OG001|Outcome|Re-Do Ablation|Participants who need a re-do ablation procedure
11317789|NCT03263702|EG000|Reported Event|De Novo|Participants with 1st procedure
11317790|NCT03263702|EG001|Reported Event|Re-Do Ablation|Participants who need a re-do ablation procedure
11317791|NCT03263780|BG000|Baseline|18F-Fluciclovine|"10mCi +/-20% 18F-fluciclovine injection~18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)"
11317792|NCT03263780|FG000|Participant Flow|18F-Fluciclovine|"10mCi +/-20% 18F-fluciclovine injection~18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)~Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution."
11317793|NCT03263780|OG000|Outcome|18F-Fluciclovine|"10mCi +/-20% 18F-fluciclovine injection~18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)~Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution."
11317794|NCT03263780|EG000|Reported Event|18F-Fluciclovine|"10mCi +/-20% 18F-fluciclovine injection~18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)~Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution."
11317795|NCT03264066|BG000|Baseline|Cohort 1 - SCCHN - Treatment Naive|In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
11317796|NCT03264066|BG001|Baseline|Cohort 2 - UC - Treatment Naive|In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317797|NCT03264066|BG002|Baseline|Cohort 3 - RCC - Treatment Naive|In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317798|NCT03264066|BG003|Baseline|Cohort 4 - SCCHN - Previous Treatment Exposure|In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317799|NCT03264066|BG004|Baseline|Cohort 5 - UC - Previous Treatment Exposure|In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317800|NCT03264066|BG005|Baseline|Cohort 6 - RCC - Previous Treatment Exposure|In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317801|NCT03264066|BG006|Baseline|Total|Total of all reporting groups
11317802|NCT03264066|FG000|Participant Flow|Cohort 1 - SCCHN - Treatment Naive|In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
11317803|NCT03264066|FG001|Participant Flow|Cohort 2 - UC - Treatment Naive|In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317804|NCT03264066|FG002|Participant Flow|Cohort 3 - RCC - Treatment Naive|In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317805|NCT03264066|FG003|Participant Flow|Cohort 4 - SCCHN - Previous Treatment Exposure|In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317806|NCT03264066|FG004|Participant Flow|Cohort 5 - UC - Previous Treatment Exposure|In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317807|NCT03264066|FG005|Participant Flow|Cohort 6 - RCC - Previous Treatment Exposure|In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317808|NCT03264066|OG000|Outcome|Cohort 1 - SCCHN - Treatment Naive|In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
11317809|NCT03264066|OG001|Outcome|Cohort 2 - UC - Treatment Naive|In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317810|NCT03264066|OG002|Outcome|Cohort 3 - RCC - Treatment Naive|In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317811|NCT03264066|OG003|Outcome|Cohort 4 - SCCHN - Previous Treatment Exposure|In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317812|NCT03264066|OG004|Outcome|Cohort 5 - UC - Previous Treatment Exposure|In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317813|NCT03264066|OG005|Outcome|Cohort 6 - RCC - Previous Treatment Exposure|In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317814|NCT03264066|OG000|Outcome|Cohorts 1-6|In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317815|NCT03264066|EG000|Reported Event|Cohort 1 - SCCHN - Treatment Naive|In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
11317816|NCT03264066|EG001|Reported Event|Cohort 2 - UC - Treatment Naive|In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317817|NCT03264066|EG002|Reported Event|Cohort 3 - RCC - Treatment Naive|In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317818|NCT03264066|EG003|Reported Event|Cohort 4 - SCCHN - Previous Treatment Exposure|In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317819|NCT03264066|EG004|Reported Event|Cohort 5 - UC - Previous Treatment Exposure|In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317820|NCT03264066|EG005|Reported Event|Cohort 6 - RCC - Previous Treatment Exposure|In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
11317821|NCT03264092|BG000|Baseline|Wet Suction|"This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317822|NCT03264092|BG001|Baseline|Dry Suction|"This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317823|NCT03264092|BG002|Baseline|Slow Pull|"This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317824|NCT03264092|BG003|Baseline|Total|Total of all reporting groups
11317825|NCT03264092|FG000|Participant Flow|Wet Suction|"This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317826|NCT03264092|FG001|Participant Flow|Dry Suction|"This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317827|NCT03264092|FG002|Participant Flow|Slow Pull|"This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=17~Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance"
11317828|NCT03264092|OG000|Outcome|Wet Suction|This arm describes the mean cellularity score obtained with the wet suction technique.
11317829|NCT03264092|OG001|Outcome|Dry Suction|This arm describes the mean cellularity score obtained with the dry suction technique.
11317830|NCT03264092|OG002|Outcome|Slow Pull|This arm describes the mean cellularity score obtained with the slow pull technique.
11317831|NCT03264092|OG000|Outcome|Wet Suction|This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the wet suction technique.
11317832|NCT03264092|OG001|Outcome|Dry Suction|This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the dry suction technique.
11317833|NCT03264092|OG002|Outcome|Slow Pull|This arm describes the number of subjects with each specific blood contamination score from all of those obtained with the slow pull technique.
11317834|NCT03264092|OG000|Outcome|Wet Suction|This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects
11317835|NCT03264092|OG001|Outcome|Dry Suction|This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects
11317836|NCT03264092|OG002|Outcome|Slow Pull|This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects
11317837|NCT03264092|EG000|Reported Event|Wet Suction|This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects
11317838|NCT03264092|EG001|Reported Event|Dry Suction|This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects
11317839|NCT03264092|EG002|Reported Event|Slow Pull|"This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects~\"
11317840|NCT03264157|BG000|Baseline|BPL HRIG + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317841|NCT03264157|BG001|Baseline|Comparator HyperRab + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317842|NCT03264157|BG002|Baseline|Total|Total of all reporting groups
11317843|NCT03264157|FG000|Participant Flow|BPL HRIG + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317844|NCT03264157|FG001|Participant Flow|Comparator HyperRab + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317845|NCT03264157|OG000|Outcome|BPL HRIG + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317846|NCT03264157|OG001|Outcome|Comparator HyperRab + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317847|NCT03264157|OG000|Outcome|BPL HRIG + RabAvert|20 IU/kg dose HRIG + active rabies vaccine
11317848|NCT03264157|OG001|Outcome|Comparator HyperRab + RabAvert|20 IU/kg dose HRIG + active rabies vaccine
11317849|NCT03264157|EG000|Reported Event|BPL HRIG + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317850|NCT03264157|EG001|Reported Event|Comparator HyperRab + RabAvert|"20 IU/kg dose HRIG + active rabies vaccine~HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.~RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28."
11317851|NCT03264248|BG000|Baseline|E-Scale|"E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users~E-Scale: Daily bodyweight system used under legs of bed"
11317852|NCT03264248|FG000|Participant Flow|E-Scale|"E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users~E-Scale: Daily bodyweight system used under legs of bed"
11317853|NCT03264248|OG000|Outcome|E-Scale|"E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users~E-Scale: Daily bodyweight system used under legs of bed"
11317854|NCT03264248|EG000|Reported Event|E-Scale|"E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users~E-Scale: Daily bodyweight system used under legs of bed"
11317855|NCT03264456|BG000|Baseline|[18F] Fluciclovine PET/MRI|"[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer~[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI~[18F] fluciclovine: [18F] fluciclovine"
11317856|NCT03264456|FG000|Participant Flow|[18F] Fluciclovine PET/MRI|"[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer~[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI~[18F] fluciclovine: [18F] fluciclovine"
11317857|NCT03264456|OG000|Outcome|[18F] Fluciclovine PET/MRI|"[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer~[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI~[18F] fluciclovine: [18F] fluciclovine"
11317858|NCT03264456|EG000|Reported Event|[18F] Fluciclovine PET/MRI|"[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer~[18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI~[18F] fluciclovine: [18F] fluciclovine"
11317859|NCT03265119|BG000|Baseline|AEVI-001|100 mg, 200 mg or 400 mg of AEVI-001 b.i.d.
11317860|NCT03265119|BG001|Baseline|Placebo|Placebo b.i.d.
11317861|NCT03265119|BG002|Baseline|Total|Total of all reporting groups
11317862|NCT03265119|FG000|Participant Flow|AEVI-001|100 mg, 200 mg or 400 mg of AEVI-001 b.i.d.
11317863|NCT03265119|FG001|Participant Flow|Placebo|Placebo b.i.d.
11317864|NCT03265119|OG000|Outcome|AEVI-001|100 mg, 200 mg or 400 mg of AEVI-001 b.i.d.
11317865|NCT03265119|OG001|Outcome|Placebo|Placebo b.i.d.
11317866|NCT03265119|EG000|Reported Event|AEVI-001|100 mg, 200 mg or 400 mg of AEVI-001 b.i.d.
11317867|NCT03265119|EG001|Reported Event|Placebo|Placebo b.i.d.
11317868|NCT03265132|BG000|Baseline|Placebo|"Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day~Placebo: sub cutaneous injection"
11317869|NCT03265132|BG001|Baseline|Anakinra|"2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)~anakinra: sub cutaneous injection"
11317870|NCT03265132|BG002|Baseline|Total|Total of all reporting groups
11317871|NCT03265132|FG000|Participant Flow|Anakinra|"2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)~anakinra: sub cutaneous injection"
11317872|NCT03265132|FG001|Participant Flow|Placebo|"Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day~Placebo: sub cutaneous injection"
11317873|NCT03265132|OG000|Outcome|Anakinra|"2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)~anakinra: sub cutaneous injection"
11317874|NCT03265132|OG001|Outcome|Placebo|"Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day~Placebo: sub cutaneous injection"
11317875|NCT03265132|OG000|Outcome|Placebo|"Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day~Placebo: sub cutaneous injection"
11317876|NCT03265132|OG001|Outcome|Anakinra|"2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)~anakinra: sub cutaneous injection"
11317877|NCT03265132|EG000|Reported Event|Anakinra|"2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)~anakinra: sub cutaneous injection"
11317878|NCT03265132|EG001|Reported Event|Placebo|"Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day~Placebo: sub cutaneous injection"
11317879|NCT03265600|BG000|Baseline|Mindfulness Training for Primary Care|"Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.~Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7."
11317880|NCT03265600|BG001|Baseline|Low-dose Comparator|"Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.~60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources."
11317881|NCT03265600|BG002|Baseline|Total|Total of all reporting groups
11317882|NCT03265600|FG000|Participant Flow|Mindfulness Training for Primary Care|"Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.~Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7."
11317883|NCT03265600|FG001|Participant Flow|Low-dose Comparator|"Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.~60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources."
11317884|NCT03265600|OG000|Outcome|Mindfulness Training for Primary Care|"Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.~Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7."
11317885|NCT03265600|OG001|Outcome|Low-dose Comparator|"Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.~60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources."
11317886|NCT03265600|EG000|Reported Event|Mindfulness Training for Primary Care|"Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.~Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7."
11317887|NCT03265600|EG001|Reported Event|Low-dose Comparator|"Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.~60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources."
11317888|NCT03265938|BG000|Baseline|Indirect Laryngoscopy|Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
11317889|NCT03265938|FG000|Participant Flow|Indirect Laryngoscopy|Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
11317890|NCT03265938|OG000|Outcome|Indirect Laryngoscopy|Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
11317891|NCT03265938|OG000|Outcome|Indirect Laryngoscopy|Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the GlideScope AVL video laryngoscope and graded the view of the larynx.
11317892|NCT03265938|EG000|Reported Event|Indirect Laryngoscopy|Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
11317893|NCT03266094|BG000|Baseline|BiZact Arm|60 Pediatric subjects undergoing tonsillectomy
11317894|NCT03266094|FG000|Participant Flow|BiZact Arm|A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
11317895|NCT03266094|OG000|Outcome|A Bipolar Instrument for Tonsillectomies|"A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.~BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger."
11317896|NCT03266094|OG000|Outcome|A Bipolar Instrument for Tonsillectomies|"A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.~BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger."
11317897|NCT03266094|OG000|Outcome|BiZact Arm|60 Pediatric subjects undergoing tonsillectomy
11317898|NCT03266094|EG000|Reported Event|BiZact Arm|60 Pediatric subjects undergoing tonsillectomy
11317899|NCT03266107|BG000|Baseline|Treatment|"Intracept~Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System"
11317900|NCT03266107|FG000|Participant Flow|Treatment|Intracept - Intraosseous radiofrequency ablation of the basivertebral nerve using the Intracept System
10827643|NCT00111007|OG000|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10848565|NCT00290472|FG001|Participant Flow|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
11317901|NCT03266107|OG000|Outcome|Treatment|"BVN Ablation~Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System"
11317902|NCT03266107|OG000|Outcome|Treatment|BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System
11317903|NCT03266107|OG000|Outcome|Treatment|"BVN Ablation~Radiofrequency ablation of the basivertebral nerve using the Intracept System"
11317904|NCT03266107|EG000|Reported Event|Treatment|"BVN Ablation~Radiofrequency ablation of the basivertebral nerve using the Intracept System"
11317905|NCT03266172|BG000|Baseline|MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)|Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
11317906|NCT03266172|BG001|Baseline|MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)|Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
11317907|NCT03266172|BG002|Baseline|MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF|Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed [DF]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (delayed fed). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
11317908|NCT03266172|BG003|Baseline|Total|Total of all reporting groups
11335954|NCT03559179|FG002|Participant Flow|Non-Waivered Providers Who Did Not Receive the Opioid Wizard|Non-Buprenorphine waivered providers are randomized to receive/not receive the Opioid Wizard. This arm represents providers who did not receive the Opioid Wizard. These providers continued to treat their patients as usual.
11317909|NCT03266172|FG000|Participant Flow|MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)|Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
11317910|NCT03266172|FG001|Participant Flow|MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)|Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
11317911|NCT03266172|FG002|Participant Flow|MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF|Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed [DF]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (DF). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
11317912|NCT03266172|OG000|Outcome|Part A: IR 120mg Fasted|Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
11317913|NCT03266172|OG000|Outcome|Part A: MT-12hour 120mg Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
11317914|NCT03266172|OG001|Outcome|Part A: MT-8hour 120mg Fasted|Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
11317915|NCT03266172|OG002|Outcome|Part A: MT-12hour 120mg Fed (High Fat)|Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
11317916|NCT03266172|OG001|Outcome|Part A:MT-8hour 120mg Fasted|Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
11317917|NCT03266172|OG000|Outcome|Part A:MT-12hour 120mg Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
11317918|NCT03266172|OG003|Outcome|Part A: IR 120mg Fasted|Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
11317919|NCT03266172|OG000|Outcome|Part A:120 mg MT-8hr Fasted and 120 mg IR Fasted|Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state and received single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state. There was washout period of 7 days between doses
10827644|NCT00111007|OG001|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
11317920|NCT03266172|OG001|Outcome|Part A:120 mg MT-12hr Fasted and 120 mg IR Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state and received single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state. There was washout period of 7 days between doses
11317921|NCT03266172|OG000|Outcome|Part C: IR 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 IR tablet in fasted state
11317922|NCT03266172|OG000|Outcome|Part C: MM-12h 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state
11317923|NCT03266172|OG001|Outcome|Part C: MM-12h 480mg Fasted|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
11317924|NCT03266172|OG001|Outcome|Part C: MM-12h 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state
11317925|NCT03266172|OG002|Outcome|Part C: MM-12h 480mg Fasted|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
11317926|NCT03266172|OG000|Outcome|Part C:MM-12h 240mg Fasted and IR 240mg Fasted|Participants in received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state and a single dose of 240 mg GSK2982772 IR tablet in fasted state. There was washout period of 7 days between doses
11317927|NCT03266172|OG000|Outcome|Part A:120 mg MT-12hour Fed and 120 mg MT-12hour Fasted|Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal and received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state. There was washout period of 7 days between doses
11317928|NCT03266172|OG000|Outcome|Part B: MT-12 120mg Fasted|Participants received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days.
11317929|NCT03266172|OG001|Outcome|Part B :MT-12 240mg Fasted|Participants received once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days
11317930|NCT03266172|OG002|Outcome|Part B :MT-12hour 300mg Fed (Standard)|Participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days
11317931|NCT03266172|OG000|Outcome|Part C MM-12h 480mg Delayed Fed (Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
10827645|NCT00111007|EG000|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827646|NCT00111007|EG001|Reported Event|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
10827647|NCT00111228|BG000|Baseline|Continuous Use of the Guardian RT|"Continuous use of the Guardian RT group~Guardian RT"
10827648|NCT00111228|BG001|Baseline|Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)|"Bi-weekly use of the Guardian RT (once every 2 weeks) group~Guardian RT"
10827649|NCT00111228|BG002|Baseline|Control Group. SMBG Monitoring|"Control group. SMBG monitoring group~SMBG only: SMBG only"
10827650|NCT00111228|BG003|Baseline|Total|Total of all reporting groups
10827651|NCT00111228|FG000|Participant Flow|Continuous Use of the Guardian RT|"Continuous use of the Guardian RT group~Guardian RT"
10827652|NCT00111228|FG001|Participant Flow|Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)|"Bi-weekly use of the Guardian RT (once every 2 weeks) group~Guardian RT"
10827653|NCT00111228|FG002|Participant Flow|Control Group. SMBG Monitoring|"Control group. SMBG monitoring group~SMBG only: SMBG only"
10827654|NCT00111228|OG000|Outcome|Continuous Use of the Guardian RT|"Continuous use of the Guardian RT group~Guardian RT"
10827655|NCT00111228|OG001|Outcome|Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)|"Bi-weekly use of the Guardian RT (once every 2 weeks) group~Guardian RT"
10827656|NCT00111228|OG002|Outcome|Control Group. SMBG Monitoring|"Control group. SMBG monitoring group~SMBG only: SMBG only"
10827657|NCT00111228|EG000|Reported Event|Continuous Use of the Guardian RT|"Continuous use of the Guardian RT group~Guardian RT"
10827658|NCT00111228|EG001|Reported Event|Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)|"Bi-weekly use of the Guardian RT (once every 2 weeks) group~Guardian RT"
10827659|NCT00111228|EG002|Reported Event|Control Group. SMBG Monitoring|"Control group. SMBG monitoring group~SMBG only: SMBG only"
10827660|NCT00111241|BG000|Baseline|Women With Breast Cancer on Aromatase Inhibitor Therapy|women with hormone receptor positive breast cancer prescribed an aromatase inhibitor
10827661|NCT00111241|BG001|Baseline|Control|healthy postmenopausal aged-matched controls from prior data base
10827662|NCT00111241|BG002|Baseline|Total|Total of all reporting groups
10827663|NCT00111241|FG000|Participant Flow|Women With Breast Cancer|women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI)
10827664|NCT00111241|FG001|Participant Flow|Healthy Control Group|healthy postmenopausal aged-matched controls from prior data base
10827665|NCT00111241|OG000|Outcome|Women With Breast Cancer|women recruited with HR+ breast cancer prescribed an AI
10827666|NCT00111241|OG001|Outcome|Control|healthy postmenopausal aged-matched controls from prior data base
10827667|NCT00111241|OG000|Outcome|Women With Breast Cancer|women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI)
10827668|NCT00111241|OG001|Outcome|Healthy Control Group|postmenopausal, nonhysterectomized, women not taking hormone replacement therapy,and with a body mass(BMI) between 20 and 37 kilograms per metre squared (kg/m2)
10827669|NCT00111241|EG000|Reported Event|Women With Breast Cancer|Of 45 women recruited with HR+ breast cancer prescribed an AI, 30 women provided paired MRI data, including 1 woman who withdrew at 0.8years due to metastatic disease. 3 women did not have even a baseline MRI (2 gave no reason and one withdrew with joint pain), 2 had no follow-up MRI, one stopped her AI, 3 cited personal reasons, one withdrew due to cancer complications, 3 changed to tamoxifen, one was lost to follow up and one gave no reason for withdrawal.
10827670|NCT00111241|EG001|Reported Event|Control Group|Of 70 women participating as controls, 8 had missing MRI data
10827671|NCT00111475|BG000|Baseline|Part A: Romiplostim 0.2 µg/kg|Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts
10827672|NCT00111475|BG001|Baseline|Part A: Romiplostim 0.5 µg/kg|Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827673|NCT00111475|BG002|Baseline|Part A: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts.
10827674|NCT00111475|BG003|Baseline|Part A: Romiplostim 3 µg/kg|Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827675|NCT00111475|BG004|Baseline|Part A: Romiplostim 6 µg/kg|Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827676|NCT00111475|BG005|Baseline|Part A: Romiplostim 10 µg/kg|Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827677|NCT00111475|BG006|Baseline|Part B: Placebo|Participants received placebo by subcutaneous injection once a week for 6 weeks.
10827678|NCT00111475|BG007|Baseline|Part B: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827679|NCT00111475|BG008|Baseline|Part B: Romiplostim 3.0 µg/kg|Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827680|NCT00111475|BG009|Baseline|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827681|NCT00111475|BG010|Baseline|Total|Total of all reporting groups
10827682|NCT00111475|FG000|Participant Flow|Part A: Romiplostim 0.2 µg/kg|Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts
10827683|NCT00111475|FG001|Participant Flow|Part A: Romiplostim 0.5 µg/kg|Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827684|NCT00111475|FG002|Participant Flow|Part A: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts.
11317932|NCT03266172|OG001|Outcome|Part C MM-12h 240mg Delayed Fed (High Fat)|Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
11317933|NCT03266172|OG002|Outcome|Part C MM-12h 480mg Fed (Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state
11317934|NCT03266172|OG000|Outcome|Part C:480mg MM-12hour Delayed Fed and 480 mg MM-12hour Fasted|Participants received single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed) and received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. There was washout period of 7 days between doses
11317935|NCT03266172|OG001|Outcome|Part C:480mg MM-12hour Fed and 480 mg MM- 12hour Fasted|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state and received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. There was washout period of 7 days between doses
11317936|NCT03266172|OG002|Outcome|Part C:240mg MM-12hour Delayed Fed and 240mg MM-12hour Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (delayed fed)) and received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. There was washout period of 7 days between doses
11317937|NCT03266172|OG002|Outcome|Part C:240mg MM-12hour Delayed Fed and 240mg MM-12hour Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (delayed fed) and received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. There was washout period of 7 days between doses
10827685|NCT00111475|FG003|Participant Flow|Part A: Romiplostim 3 µg/kg|Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827686|NCT00111475|FG004|Participant Flow|Part A: Romiplostim 6 µg/kg|Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827687|NCT00111475|FG005|Participant Flow|Part A: Romiplostim 10 µg/kg|Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827688|NCT00111475|FG006|Participant Flow|Part B: Placebo|Participants received placebo by subcutaneous injection once a week for 6 weeks.
10827689|NCT00111475|FG007|Participant Flow|Part B: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
11317938|NCT03266172|OG001|Outcome|Part A: MT-12hour 120mg Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
11317939|NCT03266172|OG002|Outcome|Part A: MT-8hour 120mg Fasted|Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
11317940|NCT03266172|OG003|Outcome|Part A: MT-12hour 120mg Fed (High Fat)|Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
11317941|NCT03266172|OG001|Outcome|Part C:MM-12h 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state.
11317942|NCT03266172|OG002|Outcome|Part C:MM-12h 480mg Fasted|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
11317943|NCT03266172|OG003|Outcome|Part C:MM-12h 480mg Fed(Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state
11317944|NCT03266172|OG004|Outcome|Part C:MM-12h 480mg Delayed Fed(Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
11317945|NCT03266172|OG005|Outcome|Part C: MM-12h 240mg Delayed Fed(High Fat)|Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
10827690|NCT00111475|FG008|Participant Flow|Part B: Romiplostim 3.0 µg/kg|Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827691|NCT00111475|FG009|Participant Flow|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827692|NCT00111475|OG000|Outcome|Part A: Romiplostim 0.2 µg/kg|Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts
11317946|NCT03266172|OG001|Outcome|Part A: MT-12hour 120mg Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state.
11317947|NCT03266172|EG000|Reported Event|Part A:IR 120mg Fasted|Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
11317948|NCT03266172|EG001|Reported Event|Part A:MT-12hour 120mg Fasted|Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
11317949|NCT03266172|EG002|Reported Event|Part A:MT-8hour 120mg Fasted|Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
11317950|NCT03266172|EG003|Reported Event|Part A:MT-12hour 120mg Fed (High Fat)|Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
11317951|NCT03266172|EG004|Reported Event|Part B:MT-12hour 120mg Fasted|Participants received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days.
11317952|NCT03266172|EG005|Reported Event|Part B:MT-12hour 240mg Fasted|Participants received once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days
11317953|NCT03266172|EG006|Reported Event|Part B:MT-12hour 300mg Fed (Standard)|Participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days
11317954|NCT03266172|EG007|Reported Event|Part C:IR 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 IR tablet in fasted state
11317955|NCT03266172|EG008|Reported Event|Part C:MM-12hour 240mg Fasted|Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state
11317956|NCT03266172|EG009|Reported Event|Part C:MM-12hour 480mg Fasted|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
11317957|NCT03266172|EG010|Reported Event|Part C:MM-12hour 480mg Fed (Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state
11317958|NCT03266172|EG011|Reported Event|Part C:MM-12hour 480mg Delayed Fed (Standard)|Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
11317959|NCT03266172|EG012|Reported Event|Part C:MM-12hour 240mg Delayed Fed (High Fat)|Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
11317960|NCT03266419|BG000|Baseline|Deep NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation~Deep NMB using rocuronium: - Drug: rocuronium~Bolus dose: 0.7 mg/kg~Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation."
11317961|NCT03266419|BG001|Baseline|Moderate NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation~Moderate NMB using rocuronium: - Drug: rocuronium~Bolus dose: none~Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation."
11317962|NCT03266419|BG002|Baseline|Total|Total of all reporting groups
11317963|NCT03266419|FG000|Participant Flow|Deep NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation~Deep NMB using rocuronium: - Drug: rocuronium~Bolus dose: 0.7 mg/kg~Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation."
11317964|NCT03266419|FG001|Participant Flow|Moderate NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation~Moderate NMB using rocuronium: - Drug: rocuronium~Bolus dose: none~Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation."
11317965|NCT03266419|OG000|Outcome|Deep NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation~Deep NMB using rocuronium: - Drug: rocuronium~Bolus dose: 0.7 mg/kg~Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation."
11317966|NCT03266419|OG001|Outcome|Moderate NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation~Moderate NMB using rocuronium: - Drug: rocuronium~Bolus dose: none~Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation."
11317967|NCT03266419|EG000|Reported Event|Deep NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation~Deep NMB using rocuronium: - Drug: rocuronium~Bolus dose: 0.7 mg/kg~Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation."
11317968|NCT03266419|EG001|Reported Event|Moderate NMB Using Rocuronium|"The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation~Moderate NMB using rocuronium: - Drug: rocuronium~Bolus dose: none~Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation."
11317969|NCT03266588|BG000|Baseline|PRN (2-8) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317970|NCT03266588|BG001|Baseline|PRN (9-14) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317971|NCT03266588|BG002|Baseline|Scheduled EOD + PRN Group|To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
11317972|NCT03266588|BG003|Baseline|Total|Total of all reporting groups
11317973|NCT03266588|FG000|Participant Flow|PRN (2-8) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317974|NCT03266588|FG001|Participant Flow|PRN (9-14) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11335955|NCT03559179|OG000|Outcome|Waivered Providers Received the Opioid Wizard|"All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
10827693|NCT00111475|OG001|Outcome|Part A: Romiplostim 0.5 µg/kg|Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827694|NCT00111475|OG002|Outcome|Part A: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts.
11317975|NCT03266588|FG002|Participant Flow|Scheduled EOD + PRN Group|To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
11317976|NCT03266588|OG000|Outcome|PRN (2-8) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317977|NCT03266588|OG001|Outcome|PRN (9-14) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317978|NCT03266588|OG002|Outcome|Scheduled EOD + PRN Group|To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
11317979|NCT03266588|EG000|Reported Event|PRN (2-8) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317980|NCT03266588|EG001|Reported Event|PRN (9-14) Group|To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
11317981|NCT03266588|EG002|Reported Event|Scheduled EOD + PRN Group|To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While ontreatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
11317982|NCT03267212|BG000|Baseline|Non-invasive Ventilation(NIV) vs. Sham Ventilation|"All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation (or Sham ventilation) applied through a full face-mask. The tests were performed in a random order.~Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training"
11317983|NCT03267212|FG000|Participant Flow|Non-invasive Ventilation First, Then Sham Ventilation|"All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation first and then Sham ventilation applied through a full face-mask.~Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training"
11317984|NCT03267212|FG001|Participant Flow|Sham Ventilation First, Then Non-invasive Ventilation|"All subjects performed FES-row testing while receiving Sham bi-level positive airway pressure ventilation first and then true ventilation applied through a full face-mask.~Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.~Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training"
11317985|NCT03267212|OG000|Outcome|Non-invasive Ventilation|Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
11317986|NCT03267212|OG001|Outcome|Sham Ventilation|Volunteers performed a maximal FES-row tests with Sham-NIV
11317987|NCT03267212|EG000|Reported Event|Non-invasive Ventilation|Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
11317988|NCT03267212|EG001|Reported Event|Sham Ventilation|Volunteers performed a maximal FES-row tests with Sham-NIV
11317989|NCT03267264|BG000|Baseline|Group 1|"BD Nano™ vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or~subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317990|NCT03267264|BG001|Baseline|Group 2|"NovoFine® vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or~subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317991|NCT03267264|BG002|Baseline|Group 3|"NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or~subject's current pen needle (NovoTwist®/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317992|NCT03267264|BG003|Baseline|Group 4|"Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or~subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317993|NCT03267264|BG004|Baseline|Total|Total of all reporting groups
11317994|NCT03267264|FG000|Participant Flow|Group 1|"BD Nano™ vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or~subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317995|NCT03267264|FG001|Participant Flow|Group 2|"NovoFine® vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or~subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317996|NCT03267264|FG002|Participant Flow|Group 3|"NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or~subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317997|NCT03267264|FG003|Participant Flow|Group 4|"Other Commercially Available Pen Needles (MHC Easy Touch, Simple Diagnostics Comfor EZ) vs Nucleus: Subjects will be randomized to~Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or~subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period"
11317998|NCT03267264|OG000|Outcome|Combined Groups|Nucleus vs all groups combined
11317999|NCT03267264|OG000|Outcome|Group 1|BD Nano™ vs Nucleus
11318000|NCT03267264|OG001|Outcome|Group 2|NovoFine® vs Nucleus
11318001|NCT03267264|OG002|Outcome|Group 3|NovoTwist®/NovoFine® Plus vs Nucleus
11318002|NCT03267264|OG003|Outcome|Group 4|Other Commercially Available Pen Needles
11318003|NCT03267264|OG000|Outcome|All Groups Combined|Resutls from comparator pen needle groups combined and compared to NUCLEUS
11318004|NCT03267264|EG000|Reported Event|Nucleus|This arm contains every subject in the study. Because every subject regardless of group recieved Nucleus
11318005|NCT03267264|EG001|Reported Event|BD Nano|This arm contains only those subjects that recieve BD Nano, included in results section described in group 1.
11318006|NCT03267264|EG002|Reported Event|NovoFine®|This arm contains only those subjects that recieved NovoFine®, included in results section described in group 2.
11318007|NCT03267264|EG003|Reported Event|NovoTwist®/NovoFine®|This arm contains only those subjects that recieved NovoTwist®/NovoFine®, included in results section described in group 3.
11318008|NCT03267264|EG004|Reported Event|Other Commercially Available Pen Needles (Unifine® Pentips®/M|This arm contains only those subjects that recieved Other Commercial Pen Needles, included in results section described in group 4.
11318009|NCT03267511|BG000|Baseline|Test Product 1|Participants were instructed to apply experimental dentifrice containing 5% KNO3) / 0.2542% NaF dentifrice with 0.5% spherical silica.
11318010|NCT03267511|BG001|Baseline|Test Product 2|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
11318011|NCT03267511|BG002|Baseline|Reference Product 1|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
11318012|NCT03267511|BG003|Baseline|Reference Product 2|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
11318013|NCT03267511|BG004|Baseline|Total|Total of all reporting groups
10827695|NCT00111475|OG003|Outcome|Part A: Romiplostim 3 µg/kg|Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
11318014|NCT03267511|FG000|Participant Flow|Test Product 1|Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.
11318015|NCT03267511|FG001|Participant Flow|Test Product 2|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% sodium tripolyphosphate (STP).
11318016|NCT03267511|FG002|Participant Flow|Reference Product 1|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
11318017|NCT03267511|FG003|Participant Flow|Reference Product 2|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
11318018|NCT03267511|OG000|Outcome|Test Product 1|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica.
11318019|NCT03267511|OG001|Outcome|Test Product 2|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
11318020|NCT03267511|OG002|Outcome|Reference Product 1|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
11318021|NCT03267511|OG003|Outcome|Reference Product 2|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
11318022|NCT03267511|OG000|Outcome|Test Product 1 vs Reference Product 1|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
11318023|NCT03267511|OG000|Outcome|Test Product 2 vs Reference Product 2|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
11318024|NCT03267511|EG000|Reported Event|Test Product 1|Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.
11318025|NCT03267511|EG001|Reported Event|Test Product 2|Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
11318026|NCT03267511|EG002|Reported Event|Reference Product 1|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
11318027|NCT03267511|EG003|Reported Event|Reference Product 2|Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
11318028|NCT03267576|BG000|Baseline|Treatment Sequence AB|Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of at 16 days (from Days 28 to 43) along with continued metformin monotherapy.
11318029|NCT03267576|BG001|Baseline|Treatment Sequence BA|Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.
11318030|NCT03267576|BG002|Baseline|Total|Total of all reporting groups
11318031|NCT03267576|FG000|Participant Flow|Treatment Sequence AB|Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of at least 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.
11318032|NCT03267576|FG001|Participant Flow|Treatment Sequence BA|Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.
11318033|NCT03267576|OG000|Outcome|Treatment Sequence AB|Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy.
11318034|NCT03267576|OG001|Outcome|Treatment Sequence BA|Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy.
11318035|NCT03267576|EG000|Reported Event|Canagliflozin 300 mg|Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) under fasted condition.
11318036|NCT03267576|EG001|Reported Event|Sitagliptin 100 mg|Participants received metformin monotherapy at stable doses >= 1500 milligram mg/day orally once daily with sitagliptin 100 mg tablet orally once daily (Treatment B) under fasted condition.
11333342|NCT03512041|EG003|Reported Event|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.~Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.~Sequence production training: All"
11333343|NCT03512067|BG000|Baseline|Patients Given EMV Ventilation|Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
11335956|NCT03559179|OG001|Outcome|Non-Waivered Providers Who Received the Opioid Wizard|Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
10827696|NCT00111475|OG004|Outcome|Part A: Romiplostim 6 µg/kg|Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
11318037|NCT03267940|BG000|Baseline|Run-in Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
11318038|NCT03267940|BG001|Baseline|Run-in Portion: PEGCISGEMATEZO|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
11318039|NCT03267940|BG002|Baseline|Expansion Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
11318040|NCT03267940|BG003|Baseline|Expansion Portion: PEGCISGEMATEZO Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
11318041|NCT03267940|BG004|Baseline|Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
11318042|NCT03267940|BG005|Baseline|Expansion Portion: CISGEM|Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
11318043|NCT03267940|BG006|Baseline|Total|Total of all reporting groups
11318044|NCT03267940|FG000|Participant Flow|Run-in Portion: PEGCISGEM|Participants received 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of cisplatin (CIS) plus 1000 mg/m^2 of gemcitabine (GEM) administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
11318045|NCT03267940|FG001|Participant Flow|Run-in Portion: PEGCISGEMATEZO|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg atezolizumab (ATEZO) (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
11318046|NCT03267940|FG002|Participant Flow|Expansion Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
11318047|NCT03267940|FG003|Participant Flow|Expansion Portion: PEGCISGEMATEZO Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
11318048|NCT03267940|FG004|Participant Flow|Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
11318049|NCT03267940|FG005|Participant Flow|Expansion Portion: CISGEM|Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
11318050|NCT03267940|OG000|Outcome|Run-in Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
11318051|NCT03267940|OG001|Outcome|Run-in Portion: PEGCISGEMATEZO|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
11318052|NCT03267940|OG000|Outcome|Expansion Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
10827697|NCT00111475|OG005|Outcome|Part A: Romiplostim 10 µg/kg|Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
11318053|NCT03267940|OG001|Outcome|Expansion Portion: PEGCISGEMATEZO Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
11318054|NCT03267940|OG002|Outcome|Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
11318055|NCT03267940|OG003|Outcome|Expansion Portion: CISGEM|Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
11318056|NCT03267940|OG002|Outcome|Expansion Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
11318057|NCT03267940|OG003|Outcome|Expansion Portion: PEGCISGEMATEZO Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
11318058|NCT03267940|OG004|Outcome|Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
11318059|NCT03267940|OG005|Outcome|Expansion Portion: CISGEM|Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
11318060|NCT03267940|EG000|Reported Event|Run-in Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
11318061|NCT03267940|EG001|Reported Event|Run-in Portion: PEGCISGEMATEZO|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
11318062|NCT03267940|EG002|Reported Event|Expansion Portion: PEGCISGEM|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
11318063|NCT03267940|EG003|Reported Event|Expansion Portion: PEGCISGEMATEZO Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
11318064|NCT03267940|EG004|Reported Event|Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly|Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
11318065|NCT03267940|EG005|Reported Event|Expansion Portion: CISGEM|Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
11318066|NCT03268343|BG000|Baseline|3 mg Cytisine|"3 mg Cytisine, Schedule A: Fed Then Fasted~Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~3 mg Cytisine, Schedule B: Fasted Then Fed~Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)."
10827698|NCT00111475|OG006|Outcome|Part B: Placebo|Participants received placebo by subcutaneous injection once a week for 6 weeks.
11318067|NCT03268343|FG000|Participant Flow|3 mg Cytisine, Schedule A: Fed Then Fasted|"Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state)."
11318068|NCT03268343|FG001|Participant Flow|3 mg Cytisine, Schedule B: Fasted Then Fed|"Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).~Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state)."
11318069|NCT03268343|OG000|Outcome|3 mg Cytisine, Fed|Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
11318070|NCT03268343|OG001|Outcome|3 mg Cytisine, Fasted|Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
11318071|NCT03268343|EG000|Reported Event|3 mg Cytisine, Fed|Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
11318072|NCT03268343|EG001|Reported Event|3 mg Cytisine, Fasted|Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
11318073|NCT03268343|EG002|Reported Event|3 mg Cytisine, Overall|"Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).~Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state)."
11318074|NCT03268590|BG000|Baseline|All Study Participants|"Breathing 21% and 100% oxygen via non-rebreather face mask~Oxygen: Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will next breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls."
11318075|NCT03268590|FG000|Participant Flow|All Study Participants|Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will then breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318076|NCT03268590|OG000|Outcome|All Study Participants|All Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will next breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318077|NCT03268590|OG000|Outcome|All Study Participants|Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will next breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318078|NCT03268590|OG000|Outcome|All Study Participants|All persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will next breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318079|NCT03268590|EG000|Reported Event|All Study Participants When Breathing Room Air|Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will then breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318080|NCT03268590|EG001|Reported Event|All Study Participants When Breathing Pure Oxygen|Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will then breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
11318081|NCT03268746|BG000|Baseline|TFNT00|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
11318082|NCT03268746|FG000|Participant Flow|TFNT00|AcrySof IQ PanOptix Multifocal intraocular lens (IOL) Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
11318083|NCT03268746|OG000|Outcome|TFNT00|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted
11318084|NCT03268746|OG000|Outcome|TFNT00 First Eye|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye
11318085|NCT03268746|OG001|Outcome|TFNT00 Second Eye|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
11318086|NCT03268746|OG000|Outcome|TFNT00 Preoperative|All subjects in FAS prior to initiation of treatment
11318087|NCT03268746|OG001|Outcome|TFNT00 Month 3|All subjects in FAS who responded at Month 3
11318088|NCT03268746|EG000|Reported Event|Preoperative|All subjects in the safety analysis set prior to initiation of treatment
11318089|NCT03268746|EG001|Reported Event|TFNT00 First Eye|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye
11318090|NCT03268746|EG002|Reported Event|TFNT00 Second Eye|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye
11318091|NCT03268746|EG003|Reported Event|TFNT00 Systemic|All subjects with attempted test article implantation (successful or aborted after contact with the eye)
11318092|NCT03268941|BG000|Baseline|Part 1: Placebo|TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
11318093|NCT03268941|BG001|Baseline|Part 1: TAK 906 Maleate 5 mg|TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
11318094|NCT03268941|BG002|Baseline|Part 1: TAK 906 Maleate 25 mg|TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
11318095|NCT03268941|BG003|Baseline|Part 1: TAK 906 Maleate 100 mg|TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
11318096|NCT03268941|BG004|Baseline|Total|Total of all reporting groups
11318097|NCT03268941|FG000|Participant Flow|Part 1: Placebo|TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
11318098|NCT03268941|FG001|Participant Flow|Part 1: TAK 906 Maleate 5 mg|TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
11318099|NCT03268941|FG002|Participant Flow|Part 1: TAK 906 Maleate 25 mg|TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
11318100|NCT03268941|FG003|Participant Flow|Part 1: TAK 906 Maleate 100 mg|TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
11318101|NCT03268941|FG004|Participant Flow|Part 2: TAK-906 Maleate 25 mg Under Fed Conditions|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) followed by fasted condition. There was a minimum 7- day washout period between the two conditions.
11318102|NCT03268941|FG005|Participant Flow|Part 2: TAK-906 Maleate 25 mg Fasted Condition|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
11318103|NCT03268941|FG006|Participant Flow|Part 2: Metoclopramide 10 mg|Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
11318104|NCT03268941|OG000|Outcome|Part 1: Placebo|TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
11318105|NCT03268941|OG001|Outcome|Part 1: TAK 906 Maleate 5 mg|TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
11318106|NCT03268941|OG002|Outcome|Part 1: TAK 906 Maleate 25 mg|TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
11318107|NCT03268941|OG003|Outcome|Part 1: TAK 906 Maleate 100 mg|TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
11318108|NCT03268941|OG004|Outcome|Part 2: TAK-906 Maleate 25 mg Fed Condition|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
11318109|NCT03268941|OG005|Outcome|Part 2: TAK-906 Maleate 25 mg Fasted Condition|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
11318110|NCT03268941|OG006|Outcome|Part 2: Metoclopramide 10 mg|Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
10827699|NCT00111475|OG007|Outcome|Part B: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827700|NCT00111475|OG008|Outcome|Part B: Romiplostim 3.0 µg/kg|Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827701|NCT00111475|OG009|Outcome|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827702|NCT00111475|OG000|Outcome|Part B: Placebo|Participants received placebo by subcutaneous injection once a week for 6 weeks.
10827703|NCT00111475|OG001|Outcome|Part B: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827704|NCT00111475|OG002|Outcome|Part B: Romiplostim 3.0 µg/kg|Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827705|NCT00111475|OG003|Outcome|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
11318111|NCT03268941|OG000|Outcome|Part 1: TAK 906 Maleate 5 mg|TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
11318112|NCT03268941|OG001|Outcome|Part 1: TAK 906 Maleate 25 mg|TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
11318113|NCT03268941|OG002|Outcome|Part 1: TAK 906 Maleate 100 mg|TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
11318114|NCT03268941|EG000|Reported Event|Part 1: Placebo|TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
11318115|NCT03268941|EG001|Reported Event|Part 1: TAK 906 Maleate 5 mg|TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
11318116|NCT03268941|EG002|Reported Event|Part 1: TAK 906 Maleate 25 mg|TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
11318117|NCT03268941|EG003|Reported Event|Part 1: TAK 906 Maleate 100 mg|TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
11318118|NCT03268941|EG004|Reported Event|Part 2: TAK-906 Maleate 25 mg Fed Condition|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
11318119|NCT03268941|EG005|Reported Event|Part 2: TAK-906 Maleate 25 mg Fasted Condition|TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
11318120|NCT03268941|EG006|Reported Event|Part 2: Metoclopramide 10 mg|Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
11318121|NCT03269435|BG000|Baseline|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with bupivacaine 0.5%~+ Normal saline IV~Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally"
11318122|NCT03269435|BG001|Baseline|Metoclopramide|"Metoclopramide 10mg IV~+ Bilateral greater occipital nerve block with normal saline~Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes"
11318123|NCT03269435|BG002|Baseline|Total|Total of all reporting groups
11335957|NCT03559179|OG000|Outcome|Waivered Providers Receive the Opioid Wizard|"All providers who have a buprenorphine waiver received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11318124|NCT03269435|FG000|Participant Flow|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with bupivacaine 0.5%~+ Normal saline IV~Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally"
11318125|NCT03269435|FG001|Participant Flow|Metoclopramide|"Metoclopramide 10mg IV~+ Bilateral greater occipital nerve block with normal saline~Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes"
11318126|NCT03269435|OG000|Outcome|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with bupivacaine 0.5%~+ Normal saline IV~Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally"
11318127|NCT03269435|OG001|Outcome|Metoclopramide|"Metoclopramide 10mg IV~+ Bilateral greater occipital nerve block with normal saline~Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes"
11318128|NCT03269435|EG000|Reported Event|Greater Occipital Nerve Block|"Bilateral greater occipital nerve block with bupivacaine 0.5%~+ Normal saline IV~Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally"
11318129|NCT03269435|EG001|Reported Event|Metoclopramide|"Metoclopramide 10mg IV~+ Bilateral greater occipital nerve block with normal saline~Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes"
11318130|NCT03269552|BG000|Baseline|Treatment (Carfilzomib, Rituximab)|"Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Rituximab: Given IV"
11318131|NCT03269552|FG000|Participant Flow|Treatment (Carfilzomib, Rituximab)|"Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Rituximab: Given IV"
11318132|NCT03269552|OG000|Outcome|Treatment (Carfilzomib, Rituximab)|"Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Rituximab: Given IV"
11318133|NCT03269552|OG000|Outcome|Treatment (Carfilzomib, Rituximab)|"Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Rituximab: Given IV"
11318134|NCT03269552|EG000|Reported Event|Treatment (Carfilzomib, Rituximab)|"Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.~Carfilzomib: Given IV~Laboratory Biomarker Analysis: Correlative studies~Rituximab: Given IV"
11318135|NCT03270085|BG000|Baseline|Colesevelam|"Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.~Baseline testing: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, medication pick up.~Treatment period: subject takes study drug 1875 mg orally twice daily with lunch and supper for 4-5 weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.~Colesevelam: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational."
10827706|NCT00111475|OG003|Outcome|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks
11333344|NCT03512067|FG000|Participant Flow|Patients Given EMV Ventilation|Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
10827707|NCT00111475|EG000|Reported Event|Part A: Romiplostim 0.2 µg/kg|Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827708|NCT00111475|EG001|Reported Event|Part A: Romiplostim 0.5 µg/kg|Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
11318136|NCT03270085|BG001|Baseline|Placebo|"Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.~Placebo: A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug."
11318137|NCT03270085|BG002|Baseline|Total|Total of all reporting groups
11318138|NCT03270085|FG000|Participant Flow|Colesevelam|"Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.~Baseline testing: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, medication pick up.~Treatment period: subject takes study drug 1875 mg orally twice daily with lunch and supper for 4-5 weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.~Colesevelam: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational."
11318139|NCT03270085|FG001|Participant Flow|Placebo|"Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.~Placebo: A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug."
11318140|NCT03270085|OG000|Outcome|Colesevelam|"Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.~Baseline testing: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, medication pick up.~Treatment period: subject takes study drug 1875 mg orally twice daily with lunch and supper for 4-5 weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.~Colesevelam: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational."
11318141|NCT03270085|OG001|Outcome|Placebo|"Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.~Placebo: A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug."
11318142|NCT03270085|EG000|Reported Event|Colesevelam|"Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.~Baseline testing: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, medication pick up.~Treatment period: subject takes study drug 1875 mg orally twice daily with lunch and supper for 4-5 weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.~Colesevelam: Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational."
11318143|NCT03270085|EG001|Reported Event|Placebo|"Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.~Treatment testing period: full transit & urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.~Placebo: A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug."
11318144|NCT03270332|BG000|Baseline|Albuterol Followed by Placebo|"Participants in this group will receive albuterol first followed by Placebo on the next visit~Albuterol: inhalation of 270μg albuterol through a spacer~Placebo: inhalation of placebo through a spacer"
11318145|NCT03270332|BG001|Baseline|Placebo Followed by Albuterol|"Participants in this group will receive placebo first followed by albuterol on the next visit~Albuterol: inhalation of 270μg albuterol through a spacer~Placebo: inhalation of placebo through a spacer"
11318146|NCT03270332|BG002|Baseline|Total|Total of all reporting groups
10827709|NCT00111475|EG002|Reported Event|Part A: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts.
11318147|NCT03270332|FG000|Participant Flow|Albuterol Followed by Placebo|"Participants in this group will receive albuterol first followed by Placebo on the next visit~Albuterol: inhalation of 270μg albuterol through a spacer~Placebo: inhalation of placebo through a spacer"
11318148|NCT03270332|FG001|Participant Flow|Placebo Followed by Albuterol|"Participants in this group will receive placebo first followed by albuterol on the next visit~Albuterol: inhalation of 270μg albuterol through a spacer~Placebo: inhalation of placebo through a spacer"
11318149|NCT03270332|OG000|Outcome|Albuterol Group|This is a cross-over study design. All participants received albuterol
11318150|NCT03270332|OG001|Outcome|Placebo Group|This is a cross-over design. All participants received placebo.
11318151|NCT03270332|OG000|Outcome|Albuterol Group|This is a cross-over study. All participants received albuterol.
11318152|NCT03270332|OG001|Outcome|Placebo Group|This is a cross-over study. All participants received placebo.
11318153|NCT03270332|EG000|Reported Event|Albuterol Group|This is a cross-over study. All participants received albuterol.
11318154|NCT03270332|EG001|Reported Event|Placebo Group|This is a cross-over study. All participants received placebo.
11318155|NCT03270436|BG000|Baseline|Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program|"The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11318156|NCT03270436|BG001|Baseline|Partnership for Improving Lifestyle Intervention Diabetes Prevention Program|"The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.~PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight."
11318157|NCT03270436|BG002|Baseline|Total|Total of all reporting groups
11318158|NCT03270436|FG000|Participant Flow|Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program|"The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11318159|NCT03270436|FG001|Participant Flow|Partnership for Improving Lifestyle Intervention Diabetes Prevention Program|"The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.~PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight."
11318160|NCT03270436|OG000|Outcome|Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program|"The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11318161|NCT03270436|OG001|Outcome|Partnership for Improving Lifestyle Intervention Diabetes Prevention Program|"The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.~PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight."
11318162|NCT03270436|EG000|Reported Event|Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program|"The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11318163|NCT03270436|EG001|Reported Event|Partnership for Improving Lifestyle Intervention Diabetes Prevention Program|"The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.~PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight."
10827710|NCT00111475|EG003|Reported Event|Part A: Romiplostim 3 µg/kg|Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
11318164|NCT03270514|BG000|Baseline|Exparel Injectable Product|"Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).~Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318165|NCT03270514|BG001|Baseline|Bupivacaine Hydrochloride|"Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).~Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318166|NCT03270514|BG002|Baseline|Total|Total of all reporting groups
11318167|NCT03270514|FG000|Participant Flow|Exparel Injectable Product|"Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).~Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318168|NCT03270514|FG001|Participant Flow|Bupivacaine Hydrochloride|"Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).~Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318169|NCT03270514|OG000|Outcome|Exparel Injectable Product|"Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).~Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318170|NCT03270514|OG001|Outcome|Bupivacaine Hydrochloride|"Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).~Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318171|NCT03270514|EG000|Reported Event|Exparel Injectable Product|"Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).~Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318172|NCT03270514|EG001|Reported Event|Bupivacaine Hydrochloride|"Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).~Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)"
11318173|NCT03270644|BG000|Baseline|Lasmiditan + Propranolol|Single 200 mg dose of lasmiditan administered orally on Day 1, then 80mg propranolol twice per day administered orally on Days 4 through 10, and 200 mg lasmiditan coadministered orally with propranolol on Day 9.
11318174|NCT03270644|FG000|Participant Flow|Lasmiditan (R); Propranolol (R) + Lasmiditan (T)|Lasmiditan 200 mg single dose administered orally on D 1 (Reference); Propranolol 80 mg administered orally twice daily D4-10(Reference); Lasmiditan 200 mg administered orally on D9 (Test).
11318175|NCT03270644|OG000|Outcome|Propranolol (Reference Treatment)|Propranolol 80 mg administered orally twice daily on Day 8.
11318176|NCT03270644|OG001|Outcome|Lasmiditan + Propranolol (Test Treatment)|Lasmiditan 200 mg coadministered with propranolol 80 mg on Day 9.
11318177|NCT03270644|OG000|Outcome|Lasmiditan (Reference Treatment)|Lasmiditan 200 mg single dose administered orally on Day 1.
11318178|NCT03270644|OG001|Outcome|Lasmiditan + Propranolol (Test Treatment)|Lasmiditan 200 mg coadministered orally with propranolol 80 mg on Day 9.
11318179|NCT03270644|OG000|Outcome|Propranolol (Reference Treatment)|Propranolol 80 mg administered orally twice daily Day 8.
11318180|NCT03270644|OG001|Outcome|Lasmiditan + Propranolol (Test Treatment)|Lasmiditan 200mg coadministered with 80 mg propranolol on Day 9.
11318181|NCT03270644|EG000|Reported Event|Lasmiditan 200 mg (Reference Treatment)|Lasmiditan 200 mg single dose administered orally on Day 1.
11318182|NCT03270644|EG001|Reported Event|Propranolol 80 mg (Reference Treatment)|Propranolol 80 mg administered orally twice daily on Day 4 to Day 10.
11318183|NCT03270644|EG002|Reported Event|Lasmiditan 200 mg + Propranolol 80 mg (Test Treatment)|Lasmiditan 200 mg coadministered orally with propranolol 80 mg on Day 9.
11318184|NCT03270657|BG000|Baseline|Intraoperative Recording During DBS Implant Surgery|Participants will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who already are scheduled to undergo the planned deep brain electrode placement for treatment of their movement disorder. Intraoperative recordings of participants' neural signals will be made through the implanted deep brain electrode(s).
11318185|NCT03270657|FG000|Participant Flow|Intraoperative Recording During DBS Implant Surgery|Participants will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who already are scheduled to undergo the planned deep brain electrode placement for treatment of their movement disorder. Intraoperative recordings of participants' neural signals will be made through the implanted deep brain electrode(s).
11318186|NCT03270657|OG000|Outcome|Intraoperative Recording During DBS Implant Surgery|Participants will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who already are scheduled to undergo the planned deep brain electrode placement for treatment of their movement disorder. Intraoperative recordings of participants' neural signals will be made through the implanted deep brain electrode(s).
11318187|NCT03270657|EG000|Reported Event|Intraoperative Recording During DBS Implant Surgery|Participants will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who already are scheduled to undergo the planned deep brain electrode placement for treatment of their movement disorder. Intraoperative recordings of participants' neural signals will be made through the implanted deep brain electrode(s).
11318188|NCT03270943|BG000|Baseline|Mindful Self-Compassion (MFY)|"An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~MFY: Mindful Self-Compassion course for teens"
11318189|NCT03270943|BG001|Baseline|Healthy Lifestyles (HLG)|"An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~HLG: Healthy Lifestyles course for teens"
11318190|NCT03270943|BG002|Baseline|Total|Total of all reporting groups
11318191|NCT03270943|FG000|Participant Flow|Mindful Self-Compassion (MFY)|"An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~MFY: Mindful Self-Compassion course for teens"
11318192|NCT03270943|FG001|Participant Flow|Healthy Lifestyles (HLG)|"An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~HLG: Healthy Lifestyles course for teens"
11318193|NCT03270943|OG000|Outcome|Mindful Self-Compassion (MFY)|"An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~MFY: Mindful Self-Compassion course for teens"
11318194|NCT03270943|OG001|Outcome|Healthy Lifestyles (HLG)|"An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~HLG: Healthy Lifestyles course for teens"
11318195|NCT03270943|EG000|Reported Event|Mindful Self-Compassion (MFY)|"An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~MFY: Mindful Self-Compassion course for teens"
11318196|NCT03270943|EG001|Reported Event|Healthy Lifestyles (HLG)|"An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.~HLG: Healthy Lifestyles course for teens"
11318197|NCT03271307|BG000|Baseline|AIm 1: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
11318198|NCT03271307|BG001|Baseline|Aim 1: Optimized Standard of Care|"Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.~Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation."
11318199|NCT03271307|BG002|Baseline|Aim 1: Facility HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).~Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318200|NCT03271307|BG003|Baseline|Aim 2: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
11318201|NCT03271307|BG004|Baseline|Aim 2: Index HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).~Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318202|NCT03271307|BG005|Baseline|Total|Total of all reporting groups
11318203|NCT03271307|FG000|Participant Flow|AIm 1: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
11318204|NCT03271307|FG001|Participant Flow|Aim 1: Optimized Standard of Care|"Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.~Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation."
10827711|NCT00111475|EG004|Reported Event|Part A: Romiplostim 6 µg/kg|Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827712|NCT00111475|EG005|Reported Event|Part A: Romiplostim 10 µg/kg|Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts.
10827713|NCT00111475|EG006|Reported Event|Part B: Placebo|Participants received placebo by subcutaneous injection once a week for 6 weeks.
10827714|NCT00111475|EG007|Reported Event|Part B: Romiplostim 1.0 µg/kg|Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
11318205|NCT03271307|FG002|Participant Flow|Aim 1: Facility HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).~Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318206|NCT03271307|FG003|Participant Flow|Aim 2: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
11318207|NCT03271307|FG004|Participant Flow|Aim 2: Index HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).~Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318208|NCT03271307|OG000|Outcome|AIm 1: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
11318209|NCT03271307|OG001|Outcome|Aim 1: Optimized Standard of Care|"Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.~Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation."
11318210|NCT03271307|OG002|Outcome|Aim 1: Facility HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).~Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318211|NCT03271307|OG003|Outcome|Aim 2: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
11318212|NCT03271307|OG004|Outcome|Aim 2: Index HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).~Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318213|NCT03271307|OG000|Outcome|Aim 1: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
11318214|NCT03271307|OG000|Outcome|Aim 2: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
11318215|NCT03271307|OG001|Outcome|Aim 2: Index HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).~Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318216|NCT03271307|EG000|Reported Event|AIm 1: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
10827715|NCT00111475|EG008|Reported Event|Part B: Romiplostim 3.0 µg/kg|Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
11318217|NCT03271307|EG001|Reported Event|Aim 1: Optimized Standard of Care|"Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.~Optimized PITC: Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation."
11318218|NCT03271307|EG002|Reported Event|Aim 1: Facility HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).~Facility HIVST: HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318219|NCT03271307|EG003|Reported Event|Aim 2: Standard of Care|Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
11318220|NCT03271307|EG004|Reported Event|Aim 2: Index HIVST|"Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).~Index HIVST: HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted."
11318221|NCT03271424|BG000|Baseline|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
11318222|NCT03271424|BG001|Baseline|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
11318223|NCT03271424|BG002|Baseline|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
11318224|NCT03271424|BG003|Baseline|Total|Total of all reporting groups
11318225|NCT03271424|FG000|Participant Flow|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
11318226|NCT03271424|FG001|Participant Flow|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
11318227|NCT03271424|FG002|Participant Flow|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
11318228|NCT03271424|OG000|Outcome|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
11318229|NCT03271424|OG000|Outcome|In Clinic Observation-Both (Oraquick Results)|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
11318230|NCT03271424|OG001|Outcome|In Clinic Observation - Both (Atomo Results)|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
11318231|NCT03271424|OG002|Outcome|In Clinic Observation-Subject Choice (Oraquick Results)|"20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
11318232|NCT03271424|OG003|Outcome|In Clinic Observation-Subject Choice (Atomo Results)|"20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
11318233|NCT03271424|EG000|Reported Event|Focus Group Discussions|Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
11318234|NCT03271424|EG001|Reported Event|In Clinic Observation-Both|"10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both~Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test."
11318235|NCT03271424|EG002|Reported Event|In Clinic Observation-Subject Choice|"20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice~Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.~Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test."
11318236|NCT03271528|BG000|Baseline|Lacosamide Then Placebo|This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial.
11318237|NCT03271528|BG001|Baseline|Placebo Then Lacosamide|This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial.
11318238|NCT03271528|BG002|Baseline|Total|Total of all reporting groups
11318239|NCT03271528|FG000|Participant Flow|Lacosamide Then Placebo|This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial.
11318240|NCT03271528|FG001|Participant Flow|Placebo Then Lacosamide|This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial.
11318241|NCT03271528|OG000|Outcome|Lacosamide|Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
11318242|NCT03271528|OG001|Outcome|Placebo Oral Capsule|Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
11318243|NCT03271528|EG000|Reported Event|Lacosamide|Subjects received 7 days of lacosamide before the alcohol self-administration trial.
11318244|NCT03271528|EG001|Reported Event|Placebo|Subjects received 7 days of placebo before the alcohol self-administration trial.
11318245|NCT03273153|BG000|Baseline|Pembrolizumab|Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.
11318246|NCT03273153|BG001|Baseline|Cobimetinib and Atezolizumab|Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
11318247|NCT03273153|BG002|Baseline|Total|Total of all reporting groups
11318248|NCT03273153|FG000|Participant Flow|Pembrolizumab|Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.
11318249|NCT03273153|FG001|Participant Flow|Cobimetinib and Atezolizumab|Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
10827716|NCT00111475|EG009|Reported Event|Part B: Romiplostim 6.0 µg/kg|Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks.
10827717|NCT00111657|BG000|Baseline|Single Arm - Pegloticase|
10827718|NCT00111657|FG000|Participant Flow|Single Arm - Pegloticase|
11318250|NCT03273153|OG000|Outcome|Pembrolizumab|Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.
11318251|NCT03273153|OG001|Outcome|Cobimetinib and Atezolizumab|Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
11318252|NCT03273153|EG000|Reported Event|Pembrolizumab|Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.
11318253|NCT03273153|EG001|Reported Event|Cobimetinib and Atezolizumab|Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
11318254|NCT03273166|BG000|Baseline|INVSENSOR00001|All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
11318255|NCT03273166|FG000|Participant Flow|INVSENSOR00001|All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
11318256|NCT03273166|OG000|Outcome|INVSENSOR00001|All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
11318257|NCT03273166|OG001|Outcome|Control SpHb Sensor|All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
11318258|NCT03273166|EG000|Reported Event|INVSENSOR00001|All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
11318259|NCT03273257|BG000|Baseline|Riociguat|"Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.~Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.~Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.~PEA will be performed at the end of medical treatment (Day 90)"
11318260|NCT03273257|BG001|Baseline|Placebo|"Patients will receive placebo for 3 months followed by pulmonary endarterectomy.~Placebo will be given analogue to riociguat with matching tablets.~PEA will be performed at the end of medical treatment (Day 90)"
11318261|NCT03273257|BG002|Baseline|Total|Total of all reporting groups
11318262|NCT03273257|FG000|Participant Flow|Riociguat|"Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.~Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.~Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.~PEA will be performed at the end of medical treatment (Day 90)"
11318263|NCT03273257|FG001|Participant Flow|Placebo|"Patients will receive placebo for 3 months followed by pulmonary endarterectomy.~Placebo will be given analogue to riociguat with matching tablets.~PEA will be performed at the end of medical treatment (Day 90)"
11318264|NCT03273257|OG000|Outcome|Riociguat|"Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.~Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.~Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.~PEA will be performed at the end of medical treatment (Day 90)"
11318265|NCT03273257|OG001|Outcome|Placebo|"Patients will receive placebo for 3 months followed by pulmonary endarterectomy.~Placebo will be given analogue to riociguat with matching tablets.~PEA will be performed at the end of medical treatment (Day 90)"
11318266|NCT03273257|EG000|Reported Event|Riociguat|"Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.~Riociguat will be initiated at 1 mg. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.~Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.~PEA will be performed at the end of medical treatment (Day 90)"
11318267|NCT03273257|EG001|Reported Event|Placebo|"Patients will receive placebo for 3 months followed by pulmonary endarterectomy.~Placebo will be given analogue to riociguat with matching tablets.~PEA will be performed at the end of medical treatment (Day 90)"
11318268|NCT03273270|BG000|Baseline|Active TMS + Gait Training|"1 Hz repetitive transcranial magnetic stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318269|NCT03273270|BG001|Baseline|Sham TMS + Gait Training|"No active stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318270|NCT03273270|BG002|Baseline|Total|Total of all reporting groups
11318271|NCT03273270|FG000|Participant Flow|Active TMS + Gait Training|"1 Hz repetitive transcranial magnetic stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318272|NCT03273270|FG001|Participant Flow|Sham TMS + Gait Training|"No active stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318273|NCT03273270|OG000|Outcome|Active TMS + Gait Training|"1 Hz repetitive transcranial magnetic stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318274|NCT03273270|OG001|Outcome|Sham TMS + Gait Training|"No active stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318275|NCT03273270|EG000|Reported Event|Active TMS + Gait Training|"1 Hz repetitive transcranial magnetic stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318276|NCT03273270|EG001|Reported Event|Sham TMS + Gait Training|"No active stimulation~transcranial magnetic stimulation: transcranial magnetic stimulation"
11318277|NCT03273283|BG000|Baseline|Intervention|"Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.~Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated."
11318278|NCT03273283|BG001|Baseline|Control|Informative leaflets regarding alcohol use
11318279|NCT03273283|BG002|Baseline|Total|Total of all reporting groups
11318280|NCT03273283|FG000|Participant Flow|Intervention|"Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.~Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated."
11318281|NCT03273283|FG001|Participant Flow|Control|Informative leaflets regarding alcohol use
11318282|NCT03273283|OG000|Outcome|Intervention|"Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.~Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated."
11318283|NCT03273283|OG001|Outcome|Control|Informative leaflets regarding alcohol use
11318284|NCT03273283|EG000|Reported Event|Intervention|"Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.~Brief Intervention: Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated."
11318285|NCT03273283|EG001|Reported Event|Control|Informative leaflets regarding alcohol use
11318286|NCT03273387|BG000|Baseline|Sugar Pill|"The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.~Placebo oral capsule: The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy."
11318287|NCT03273387|BG001|Baseline|Trimetazidine|"The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.~Trimetazidine: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy."
11318288|NCT03273387|BG002|Baseline|Total|Total of all reporting groups
11318289|NCT03273387|FG000|Participant Flow|Sugar Pill|"The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.~Placebo oral capsule: The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy."
11318290|NCT03273387|FG001|Participant Flow|Trimetazidine|"The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.~Trimetazidine: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy."
11318291|NCT03273387|OG000|Outcome|Sugar Pill|"The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.~Placebo oral capsule: The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy."
11318292|NCT03273387|OG001|Outcome|Trimetazidine|"The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.~Trimetazidine: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy."
11318293|NCT03273387|EG000|Reported Event|Sugar Pill|"The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.~Placebo oral capsule: The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy."
11318294|NCT03273387|EG001|Reported Event|Trimetazidine|"The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.~Trimetazidine: The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy."
11318295|NCT03273426|BG000|Baseline|Core Needle Biopsy|Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318296|NCT03273426|BG001|Baseline|Vacuum-assisted Biopsy|Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318297|NCT03273426|BG002|Baseline|Total|Total of all reporting groups
11318298|NCT03273426|FG000|Participant Flow|Core Needle Biopsy|"Image-guided core needle biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.~The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively."
11318299|NCT03273426|FG001|Participant Flow|Vacuum-assisted Biopsy|"Image-guided vacuum-assisted biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.~The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively."
11318300|NCT03273426|OG000|Outcome|Core Needle Biopsy|Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318301|NCT03273426|OG001|Outcome|Vacuum-assisted Biopsy|Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318302|NCT03273426|OG002|Outcome|Total|Ultrasound-guided core needle biopsy + vacuum-assisted biopsy
11318303|NCT03273426|EG000|Reported Event|Core Needle Biopsy|Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318304|NCT03273426|EG001|Reported Event|Vacuum-assisted Biopsy|Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
11318305|NCT03273543|BG000|Baseline|Nasal Tip Projection|Restylane® Defyne: hyaluronic acid filler injection
11318306|NCT03273543|BG001|Baseline|Upper Lip Position|Restylane® Defyne: hyaluronic acid filler injection
11318307|NCT03273543|BG002|Baseline|Total|Total of all reporting groups
11318308|NCT03273543|FG000|Participant Flow|Nasal Tip Projection|Restylane® Defyne: hyaluronic acid filler injection
11318309|NCT03273543|FG001|Participant Flow|Upper Lip Position|Restylane® Defyne: hyaluronic acid filler injection
11318310|NCT03273543|OG000|Outcome|Nasal Tip Projection|"Restylane® Defyne: hyaluronic acid filler injection~Mean nasal tip projection measured by comparing baseline vs post-tx Goode's Ratio"
11318311|NCT03273543|OG000|Outcome|Upper Lip Position|Restylane® Defyne: hyaluronic acid filler injection
11318312|NCT03273543|EG000|Reported Event|Nasal Tip Projection|Restylane® Defyne: hyaluronic acid filler injection
11318313|NCT03273543|EG001|Reported Event|Upper Lip Position|Restylane® Defyne: hyaluronic acid filler injection
11333345|NCT03512067|OG000|Outcome|Patients Given EMV Ventilation|Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
10827719|NCT00111657|OG000|Outcome|Single Arm|
10827720|NCT00111657|OG000|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
10827721|NCT00111657|OG000|Outcome|Single Arm - Pegloticase|
11318314|NCT03273673|BG000|Baseline|Biofeedback Intervention|"The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.~Biofeedback Intervention: Visual and Tactile Biofeedback"
11318315|NCT03273673|BG001|Baseline|Control|The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
11318316|NCT03273673|BG002|Baseline|Total|Total of all reporting groups
11318317|NCT03273673|FG000|Participant Flow|Biofeedback Intervention|"The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.~Biofeedback Intervention: Visual and Tactile Biofeedback"
11318318|NCT03273673|FG001|Participant Flow|Control|The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
11318319|NCT03273673|OG000|Outcome|Biofeedback Intervention|"The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.~Biofeedback Intervention: Visual and Tactile Biofeedback"
11318320|NCT03273673|OG001|Outcome|Control|The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
11318321|NCT03273673|EG000|Reported Event|Biofeedback Intervention|"The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.~Biofeedback Intervention: Visual and Tactile Biofeedback"
11318322|NCT03273673|EG001|Reported Event|Control|The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
11318323|NCT03273946|BG000|Baseline|All Participants|The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
11318324|NCT03273946|FG000|Participant Flow|All Participants|The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
10827722|NCT00111657|EG000|Reported Event|Single Arm - Pegloticase|
10827723|NCT00111761|BG000|Baseline|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
10827724|NCT00111761|BG001|Baseline|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
11318325|NCT03273946|OG000|Outcome|All Participants|The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
11318326|NCT03273946|EG000|Reported Event|All Participants|The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
11318327|NCT03274076|BG000|Baseline|Tofacitinib Double Blind 0-24 Weeks|Participants treated with an oral medication tofacitinib 5 mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318328|NCT03274076|BG001|Baseline|Placebo Double Blind 0-24 Weeks|Participants treated with oral placebo tablet 5 mg twice a daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318329|NCT03274076|BG002|Baseline|Total|Total of all reporting groups
11318330|NCT03274076|FG000|Participant Flow|Tofacitinib Double Blind 0-24 Weeks|Participants treated with an oral medication tofacitinib 5 mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318331|NCT03274076|FG001|Participant Flow|Placebo Double Blind 0-24 Weeks|Participants treated with an oral placebo 5 mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318332|NCT03274076|FG002|Participant Flow|Tofacitinib to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318333|NCT03274076|FG003|Participant Flow|Placebo to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318334|NCT03274076|OG000|Outcome|Tofacitinib Double Blind 0-24 Weeks|Participants treated with an oral medication tofacitinib 5 mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318335|NCT03274076|OG001|Outcome|Placebo Double Blind 0-24 Weeks|Participants treated with oral placebo tablet 5 mg twice a day for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318336|NCT03274076|OG000|Outcome|Tofacitinib Double Blind 0-24 Weeks|Participants treated with an oral medication tofacitinib 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318337|NCT03274076|OG001|Outcome|Placebo Double Blind 0-24 Weeks|Participants treated with an oral placebo tablet 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318338|NCT03274076|OG002|Outcome|Tofacitinib to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318339|NCT03274076|OG003|Outcome|Placebo to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318340|NCT03274076|OG002|Outcome|Tofacitinib to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5 mg tofacitinib twice daily for 24 weeks.
11318341|NCT03274076|OG003|Outcome|Placebo to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5 mg tofacitinib twice daily for 24 weeks.
11318342|NCT03274076|OG000|Outcome|Tofacitinib Double Blind 0 - 24 Weeks|Participants treated with an oral medication tofacitinib 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318343|NCT03274076|OG001|Outcome|Placebo Double Blind 0 - 24 Weeks|Participants treated with an oral placebo tablet 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318344|NCT03274076|OG000|Outcome|Tofacitinib Double Blind 0-24 Weeks|.Participants treated with an oral medication tofacitinib 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318345|NCT03274076|OG002|Outcome|Tofacitinib (DB Tofacitinib) Open Label 24 - 48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318346|NCT03274076|OG003|Outcome|Tofacitinib (DB Placebo) Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318347|NCT03274076|EG000|Reported Event|Tofacitinib Double Blind 0-24 Weeks|.Participants treated with an oral medication tofacitinib 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318348|NCT03274076|EG001|Reported Event|Placebo Double Blind 0-24 Weeks|Participants treated with an oral placebo tablet 5mg twice daily for 24 weeks with option to enter 24 weeks of open label tofacitinib.
11318349|NCT03274076|EG002|Reported Event|Tofacitinib to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318350|NCT03274076|EG003|Reported Event|Placebo to Tofacitinib Open Label 24-48 Weeks|Post double blind completion, participants receive 5mg tofacitinib twice daily for 24 weeks.
11318351|NCT03274440|BG000|Baseline|All Participants|In this within-subjects study, all participants received all three study drugs in random order. Demographic data is provided for all study participants together.
11318352|NCT03274440|FG000|Participant Flow|Order A|"Order A: THC, CBD, PBO.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318353|NCT03274440|FG001|Participant Flow|Order B|"Order B: THC, PBO, CBD.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318354|NCT03274440|FG002|Participant Flow|Order C|"Order C: CBD, THC, PBO.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318355|NCT03274440|FG003|Participant Flow|Order D|"Order D: CBD, PBO, THC.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
10827725|NCT00111761|BG002|Baseline|Total|Total of all reporting groups
11318356|NCT03274440|FG004|Participant Flow|Order E|"Order E: PBO, THC, CBD.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318357|NCT03274440|FG005|Participant Flow|Order F|"Order F: PBO, CBD, THC.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318358|NCT03274440|OG000|Outcome|High THC/Low CBD Marijuana (Cannabis)|"This condition involves the ingestion of marijuana (cannabis) with a high THC (5-10%) and low CBD (<1%) content.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318359|NCT03274440|OG001|Outcome|Low THC/High CBD Marijuana (Cannabis)|"This condition involves the ingestion of marijuana (cannabis) with a low THC (<1%) and high CBD (>10%) content.~Cannabis: THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
11318360|NCT03274440|OG002|Outcome|No THC/No CBD|"This condition involves the ingestion of a placebo control with no THC and no CBD content.~Placebo: Placebo control group, not receiving THC or CBD."
11318361|NCT03274440|EG000|Reported Event|High THC/Low CBD Cannabis|Adverse events after receiving High THC (5-10%)/Low CBD (<1%) cannabis
11318362|NCT03274440|EG001|Reported Event|High CBD/Low THC Cannabis|Adverse events after receiving Low THC (<1%)/High CBD (5-10%) cannabis
11318363|NCT03274440|EG002|Reported Event|Placebo Cannabis|Adverse events after receiving placebo (0% THC/ 0% CBD) cannabis
11318364|NCT03274453|BG000|Baseline|Naive Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318365|NCT03274453|BG001|Baseline|Naive Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318366|NCT03274453|BG002|Baseline|Tolerant Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318367|NCT03274453|BG003|Baseline|Tolerant Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318368|NCT03274453|BG004|Baseline|Total|Total of all reporting groups
11318369|NCT03274453|FG000|Participant Flow|Naive Placebo|Saline will be administered at the same rate as the ketamine infusion.
10827726|NCT00111761|FG000|Participant Flow|Panitumumab With FOLFIRI|Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
11318370|NCT03274453|FG001|Participant Flow|Naive Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318371|NCT03274453|FG002|Participant Flow|Tolerant Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318372|NCT03274453|FG003|Participant Flow|Tolerant Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318373|NCT03274453|OG000|Outcome|Naive Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318374|NCT03274453|OG001|Outcome|Naive Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318375|NCT03274453|OG002|Outcome|Tolerant Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318376|NCT03274453|OG003|Outcome|Tolerant Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
10827727|NCT00111761|FG001|Participant Flow|Panitumumab With IFL|Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
10827728|NCT00111761|OG000|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
10827729|NCT00111761|OG000|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
10827730|NCT00111761|EG000|Reported Event|Panitumumab Plus IFL|
10827731|NCT00111761|EG001|Reported Event|Panitumumab Plus FOLFIRI|
11318377|NCT03274453|EG000|Reported Event|Naive Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318378|NCT03274453|EG001|Reported Event|Naive Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318379|NCT03274453|EG002|Reported Event|Tolerant Placebo|Saline will be administered at the same rate as the ketamine infusion.
11318380|NCT03274453|EG003|Reported Event|Tolerant Ketamine|"After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine.~Infusion will be maintained for 24 hours."
11318381|NCT03274466|BG000|Baseline|Closed Incision Negative Pressure Therapy (ciNPT)|"Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit~Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days."
11318382|NCT03274466|BG001|Baseline|Standard of Care Dressing|"Silver impregnated dressing~Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively."
11318383|NCT03274466|BG002|Baseline|Total|Total of all reporting groups
11318384|NCT03274466|FG000|Participant Flow|Closed Incision Negative Pressure Therapy (ciNPT)|"Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit~Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days."
11318385|NCT03274466|FG001|Participant Flow|Standard of Care Dressing|"Silver impregnated dressing~Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively."
11318386|NCT03274466|OG000|Outcome|Closed Incision Negative Pressure Therapy (ciNPT)|"Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit~Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days."
11318387|NCT03274466|OG001|Outcome|Standard of Care Dressing|"Silver impregnated dressing~Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively."
11318388|NCT03274466|EG000|Reported Event|Closed Incision Negative Pressure Therapy (ciNPT)|"Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit~Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days."
11318389|NCT03274466|EG001|Reported Event|Standard of Care Dressing|"Silver impregnated dressing~Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively."
11318390|NCT03274518|BG000|Baseline|Online Hemodiafiltration|"Patients were included in this study group per sequence:~Online hemodiafiltration (olHDF) first for 1 month, then expanded hemodialysis (HDx) for 1 month.~Baseline characteristics assessed:~Age~Gender~Ethnicity~Region of Enrollment~Serum Beta-2 Microglobulin"
11318391|NCT03274518|BG001|Baseline|Expanded Hemodialysis|"Patients were included in this study group per sequence:~Expanded hemodialysis (HDx) first for 1 month, then online hemodiafiltration (olHDF) for 1 month.~Baseline characteristics assessed:~Age~Gender~Ethnicity~Region of Enrollment~Serum Beta-2 Microglobulin"
11318392|NCT03274518|BG002|Baseline|Total|Total of all reporting groups
11318393|NCT03274518|FG000|Participant Flow|Online Hemodiafiltration|"Arm description: Online Hemodiafiltration first, then expanded hemodialysis.~First, patients changed fom conventional HD to online hemodiafiltration for 1 month.~Then, patients returned to conventional HD for 2 weeks (washout period). Then, patients underwent the second intervention (expanded hemodialysis) for 1 month, in a cross-over design."
10827732|NCT00111800|BG000|Baseline|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
11318394|NCT03274518|FG001|Participant Flow|Expanded Hemodialysis|"Arm description: expanded hemodialysis first, then online hemodiafiltration.~Intervention: Conversion from conventional HD to expanded hemodialysis for 1 month.~Then, patients returned to conventional HD for 2 weeks (washout period). Then, they underwent the second intervention (online hemodiafiltration), for 1 month, in a cross-over design."
11318395|NCT03274518|OG000|Outcome|Online Hemodiafiltration|"The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.~The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients."
11318396|NCT03274518|OG001|Outcome|Expanded Hemodialysis|High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin.
11318397|NCT03274518|EG000|Reported Event|Online Hemodiafiltration|"The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid.~The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.~Online Hemodiafiltration: Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month.~Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis."
11318398|NCT03274518|EG001|Reported Event|Expanded Hemodialysis|"More recently, membranes with high cutoff values, but with tight pore size distribution have been developed. The main concept is to keep both cutoff and retention onset values close to each other, but with a cutoff value lower than of albumin. This should allow removal of middle-to-high weight range uremic toxins, with very low albumin leak. Thus, these membranes, denominated high retention onset (HRO) membranes, allow performing both diffusive and convective processes in a conventional hemodialysis machine. Expanded Hemodialysis: Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month.~High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialy"
11318399|NCT03274856|BG000|Baseline|Treatment Sequence 1|GLWL-01 (450mg) twice a day/ Placebo. Participants randomized to 1 of 2 treatment sequences; GLWL-01/placebo or placebo/GLWL-01 (Treatment Period 1 double-blind treatment phase/Treatment Period 2 double-blind treatment phase). During single-blind placebo lead-in phases, participants receive 3 capsules of 150-mg placebo twice daily (BID) for 14 days. During double-blind treatment phases, participants receive 3 capsules of 150-mg GLWL-01 (450 mg total dose) BID or identical placebo BID for 28 days
11318400|NCT03274856|BG001|Baseline|Treatment Sequence 2|Placebo / GLWL-01 (450mg), twice a day. Participants randomized to 1 of 2 treatment sequences; GLWL-01/placebo or placebo/GLWL-01 (Treatment Period 1 double-blind treatment phase/Treatment Period 2 double-blind treatment phase). During single-blind placebo lead-in phases, participants receive 3 capsules of 150-mg placebo twice daily (BID) for 14 days. During double-blind treatment phases, participants receive 3 capsules of 150-mg GLWL-01 (450 mg total dose) BID or identical placebo BID for 28 days
11318401|NCT03274856|BG002|Baseline|Total|Total of all reporting groups
11318402|NCT03274856|FG000|Participant Flow|Treatment Sequence 1|GLWL-01 (450mg) twice a day/ Placebo. Participants randomized to 1 of 2 treatment sequences; GLWL-01/placebo or placebo/GLWL-01 (Treatment Period 1 double-blind treatment phase/Treatment Period 2 double-blind treatment phase). During single-blind placebo lead-in phases, participants receive 3 capsules of 150-mg placebo twice daily (BID) for 14 days. During double-blind treatment phases, participants receive 3 capsules of 150-mg GLWL-01 (450 mg total dose) BID or identical placebo BID for 28 days
11318403|NCT03274856|FG001|Participant Flow|Treatment Sequence 2|Placebo / GLWL-01 (450mg), twice a day. Participants randomized to 1 of 2 treatment sequences; GLWL-01/placebo or placebo/GLWL-01 (Treatment Period 1 double-blind treatment phase/Treatment Period 2 double-blind treatment phase). During single-blind placebo lead-in phases, participants receive 3 capsules of 150-mg placebo twice daily (BID) for 14 days. During double-blind treatment phases, participants receive 3 capsules of 150-mg GLWL-01 (450 mg total dose) BID or identical placebo BID for 28 days
11318404|NCT03274856|OG000|Outcome|GLWL-01|Participants who received GLWL in either double blind treatment phase
11318405|NCT03274856|OG001|Outcome|Placebo|Participants who received placebo in either double blind treatment phase
11318406|NCT03274856|OG000|Outcome|GLWL-01 Single Dose|Day 14 observation
11318407|NCT03274856|OG001|Outcome|GLWL-01 Multiple Dose|Day 42 observation
11318408|NCT03274856|EG000|Reported Event|GLWL|Participants who received GLWL in either double blind treatment phase
11318409|NCT03274856|EG001|Reported Event|Placebo|Participants who received placebo in either double blind treatment phase
11318410|NCT03274986|BG000|Baseline|DFT015|ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
11318411|NCT03274986|BG001|Baseline|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11318412|NCT03274986|BG002|Baseline|Total|Total of all reporting groups
11318413|NCT03274986|FG000|Participant Flow|DFT015|ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
11318414|NCT03274986|FG001|Participant Flow|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11318415|NCT03274986|OG000|Outcome|DFT015|ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
11318416|NCT03274986|OG001|Outcome|SN60WF|ACRYSOF® IQ Monofocal IOL, bilateral implantation
11318417|NCT03274986|OG000|Outcome|DFT015 First Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
11318418|NCT03274986|OG001|Outcome|DFT015 Second Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
11318419|NCT03274986|EG000|Reported Event|Preoperative|All subjects in the safety analysis set prior to initiation of treatment
11318420|NCT03274986|EG001|Reported Event|DFT015 First Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
11318421|NCT03274986|EG002|Reported Event|DFT015 Second Eye|All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
11318422|NCT03274986|EG003|Reported Event|DFT015 Systemic|All subjects with attempted test article implantation (successful or aborted after contact with the eye)
11318423|NCT03274986|EG004|Reported Event|SN60WF First Eye|All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye
11318424|NCT03274986|EG005|Reported Event|SN60WF Second Eye|All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye
11318425|NCT03274986|EG006|Reported Event|SN60WF Systemic|All subjects with attempted control article implantation (successful or aborted after contact with the eye)
11318426|NCT03274999|BG000|Baseline|All Study Participants|All participants randomized to receive TrueTear™ device either intranasally (test) or extranasally (control) on Days 0 and 14.
11318427|NCT03274999|FG000|Participant Flow|TrueTear™ Intranasal Then Extranasal Application|TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.
11318428|NCT03274999|FG001|Participant Flow|TrueTear™ Extranasal Then Intranasal Application|TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.
11318429|NCT03274999|OG000|Outcome|TrueTear™ Extranasal Application|TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
11318430|NCT03274999|OG001|Outcome|TrueTear™ Intranasal Application|TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
11318431|NCT03274999|EG000|Reported Event|TrueTear™ Extranasal Application|TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
11318432|NCT03274999|EG001|Reported Event|TrueTear™ Intranasal Application|TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
11318433|NCT03275246|BG000|Baseline|Total Knee Arthroplasty|"Patients undergoing total knee arthroplasty~X-PSI Knee System: Patients are operated with X-PSI Knee System guides"
11318434|NCT03275246|FG000|Participant Flow|Total Knee Arthroplasty|"Patients undergoing total knee arthroplasty~X-PSI Knee System: Patients are operated with X-PSI Knee System guides"
11318435|NCT03275246|OG000|Outcome|Total Knee Arthroplasty|"Patients undergoing total knee arthroplasty~X-PSI Knee System: Patients are operated with X-PSI Knee System guides"
11318436|NCT03275246|EG000|Reported Event|Total Knee Arthroplasty|"Patients undergoing total knee arthroplasty~X-PSI Knee System: Patients are operated with X-PSI Knee System guides"
11318437|NCT03275389|BG000|Baseline|D-SUIV Adjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318438|NCT03275389|BG001|Baseline|D-SUIV Adjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
10827733|NCT00111800|BG001|Baseline|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827734|NCT00111800|BG002|Baseline|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
10827735|NCT00111800|BG003|Baseline|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
10827736|NCT00111800|BG004|Baseline|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
10827737|NCT00111800|BG005|Baseline|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
10827738|NCT00111800|BG006|Baseline|Total|Total of all reporting groups
10827739|NCT00111800|FG000|Participant Flow|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
10827740|NCT00111800|FG001|Participant Flow|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827741|NCT00111800|FG002|Participant Flow|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
10827742|NCT00111800|FG003|Participant Flow|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
10827743|NCT00111800|FG004|Participant Flow|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
10827744|NCT00111800|FG005|Participant Flow|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
10827745|NCT00111800|OG000|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
10827746|NCT00111800|OG001|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827747|NCT00111800|OG002|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
10827748|NCT00111800|OG003|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
11318439|NCT03275389|BG002|Baseline|D-SUIV Adjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318440|NCT03275389|BG003|Baseline|D-SUIV Adjuvanted Group 4|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318441|NCT03275389|BG004|Baseline|D-SUIV Adjuvanted Group 5|Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318442|NCT03275389|BG005|Baseline|D-SUIV Adjuvanted Group 6|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318443|NCT03275389|BG006|Baseline|D-SUIV Unadjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318444|NCT03275389|BG007|Baseline|D-SUIV Unadjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318445|NCT03275389|BG008|Baseline|D-SUIV Unadjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318446|NCT03275389|BG009|Baseline|IIV4 Group|Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318447|NCT03275389|BG010|Baseline|Total|Total of all reporting groups
11318448|NCT03275389|FG000|Participant Flow|D-SUIV Adjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318449|NCT03275389|FG001|Participant Flow|D-SUIV Adjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318450|NCT03275389|FG002|Participant Flow|D-SUIV Adjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318451|NCT03275389|FG003|Participant Flow|D-SUIV Adjuvanted Group 4|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318452|NCT03275389|FG004|Participant Flow|D-SUIV Adjuvanted Group 5|Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318453|NCT03275389|FG005|Participant Flow|D-SUIV Adjuvanted Group 6|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318454|NCT03275389|FG006|Participant Flow|D-SUIV Unadjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318455|NCT03275389|FG007|Participant Flow|D-SUIV Unadjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318456|NCT03275389|FG008|Participant Flow|D-SUIV Unadjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318457|NCT03275389|FG009|Participant Flow|IIV4 Group|Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318458|NCT03275389|OG000|Outcome|D-SUIV Adjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318459|NCT03275389|OG001|Outcome|D-SUIV Adjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
10827749|NCT00111800|OG004|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
11318460|NCT03275389|OG002|Outcome|D-SUIV Adjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318461|NCT03275389|OG003|Outcome|D-SUIV Adjuvanted Group 4|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318462|NCT03275389|OG004|Outcome|D-SUIV Adjuvanted Group 5|Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318463|NCT03275389|OG005|Outcome|D-SUIV Adjuvanted Group 6|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318464|NCT03275389|OG006|Outcome|D-SUIV Unadjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318465|NCT03275389|OG007|Outcome|D-SUIV Unadjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318466|NCT03275389|OG008|Outcome|D-SUIV Unadjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318467|NCT03275389|OG009|Outcome|IIV4 Group|Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318468|NCT03275389|EG000|Reported Event|D-SUIV Adjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318469|NCT03275389|EG001|Reported Event|D-SUIV Adjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318470|NCT03275389|EG002|Reported Event|D-SUIV Adjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318471|NCT03275389|EG003|Reported Event|D-SUIV Adjuvanted Group 4|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318472|NCT03275389|EG004|Reported Event|D-SUIV Adjuvanted Group 5|Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318473|NCT03275389|EG005|Reported Event|D-SUIV Adjuvanted Group 6|Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318474|NCT03275389|EG006|Reported Event|D-SUIV Unadjuvanted Group 1|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318475|NCT03275389|EG007|Reported Event|D-SUIV Unadjuvanted Group 2|Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318476|NCT03275389|EG008|Reported Event|D-SUIV Unadjuvanted Group 3|Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318477|NCT03275389|EG009|Reported Event|IIV4 Group|Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
11318478|NCT03275623|BG000|Baseline|No Antibiotic Treatment|"Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318479|NCT03275623|BG001|Baseline|Antibiotic Treatment|"Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318480|NCT03275623|BG002|Baseline|Total|Total of all reporting groups
11318481|NCT03275623|FG000|Participant Flow|Antibiotic Treatment|"Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318482|NCT03275623|FG001|Participant Flow|No Antibiotic Treatment|"Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318483|NCT03275623|OG000|Outcome|No Antibiotic Treatment|"Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11335958|NCT03559179|OG001|Outcome|Non-Waivered Providers Who Receive Opioid Wizard|"All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid. This arm of providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11318484|NCT03275623|OG001|Outcome|Antibiotic Treatment|"Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318485|NCT03275623|EG000|Reported Event|No Antibiotic Treatment|"Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318486|NCT03275623|EG001|Reported Event|Antibiotic Treatment|"Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.~Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.~Standard Prenatal Care: Continued surveillance of urinary cultures"
11318487|NCT03275766|BG000|Baseline|DLPFC Facilitatory|"repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC~usually effective in depression treatment, probably no specific effect on psychomotor slowing~DLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318488|NCT03275766|BG001|Baseline|preSMA/SMA Inhibitory|"repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA~should inhibit overactive premotor cortices~SMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318489|NCT03275766|BG002|Baseline|preSMA/SMA Facilitatory|"intermittend theta burst stimulation (iTBS) over preSMA/SMA~should facilitate neural activity within premotor cortices~SMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli"
11318490|NCT03275766|BG003|Baseline|Sham TMS|"sham rTMS with a placebo coil over occipital cortex~should have no effect at all (no transcranial magnetic stimulation, only sound)~sham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session"
11318491|NCT03275766|BG004|Baseline|Total|Total of all reporting groups
11318492|NCT03275766|FG000|Participant Flow|DLPFC Facilitatory|"repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC~usually effective in depression treatment, probably no specific effect on psychomotor slowing~DLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318493|NCT03275766|FG001|Participant Flow|preSMA/SMA Inhibitory|"repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA~should inhibit overactive premotor cortices~SMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318494|NCT03275766|FG002|Participant Flow|preSMA/SMA Facilitatory|"intermittend theta burst stimulation (iTBS) over preSMA/SMA~should facilitate neural activity within premotor cortices~SMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli"
11318495|NCT03275766|FG003|Participant Flow|Sham TMS|"sham rTMS with a placebo coil over occipital cortex~should have no effect at all (no transcranial magnetic stimulation, only sound)~sham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session"
11318496|NCT03275766|OG000|Outcome|DLPFC Facilitatory|"repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC~usually effective in depression treatment, probably no specific effect on psychomotor slowing~DLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318497|NCT03275766|OG001|Outcome|preSMA/SMA Inhibitory|"repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA~should inhibit overactive premotor cortices~SMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318498|NCT03275766|OG002|Outcome|preSMA/SMA Facilitatory|"intermittend theta burst stimulation (iTBS) over preSMA/SMA~should facilitate neural activity within premotor cortices~SMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli"
11318499|NCT03275766|OG003|Outcome|Sham TMS|"sham rTMS with a placebo coil over occipital cortex~should have no effect at all (no transcranial magnetic stimulation, only sound)~sham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session"
11318500|NCT03275766|EG000|Reported Event|DLPFC Facilitatory|"repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC~usually effective in depression treatment, probably no specific effect on psychomotor slowing~DLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11335959|NCT03559179|OG000|Outcome|Waivered Providers Received the Opioid Wizard|"All providers who have a buprenorphine waiver received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11318501|NCT03275766|EG001|Reported Event|preSMA/SMA Inhibitory|"repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA~should inhibit overactive premotor cortices~SMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli"
11318502|NCT03275766|EG002|Reported Event|preSMA/SMA Facilitatory|"intermittend theta burst stimulation (iTBS) over preSMA/SMA~should facilitate neural activity within premotor cortices~SMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli"
11318503|NCT03275766|EG003|Reported Event|Sham TMS|"sham rTMS with a placebo coil over occipital cortex~should have no effect at all (no transcranial magnetic stimulation, only sound)~sham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session"
11318504|NCT03275870|BG000|Baseline|Hydroxychloroquine Treatment|"Hydroxychloroquine 200mg BID for 6 months~Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months"
11318505|NCT03275870|FG000|Participant Flow|Hydroxychloroquine Treatment|"Hydroxychloroquine 200mg BID for 6 months~Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months"
11318506|NCT03275870|OG000|Outcome|Hydroxychloroquine Treatment|"Hydroxychloroquine 200mg BID for 6 months~Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months"
11318507|NCT03275870|EG000|Reported Event|Hydroxychloroquine Treatment|"Hydroxychloroquine 200mg BID for 6 months~Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months"
11318508|NCT03276026|BG000|Baseline|Control Group/Neostigmine|"The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.~Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318509|NCT03276026|BG001|Baseline|Study Group/Sugammadex|"33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.~Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318510|NCT03276026|BG002|Baseline|Total|Total of all reporting groups
11318511|NCT03276026|FG000|Participant Flow|Control Group/Neostigmine|"The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.~Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318512|NCT03276026|FG001|Participant Flow|Study Group/Sugammadex|"33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.~Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318513|NCT03276026|OG000|Outcome|Control Group/Neostigmine|"The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.~Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318514|NCT03276026|OG001|Outcome|Study Group/Sugammadex|"33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.~Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318515|NCT03276026|EG000|Reported Event|Control Group/Neostigmine|"The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.~Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318516|NCT03276026|EG001|Reported Event|Study Group/Sugammadex|"33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.~Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures."
11318517|NCT03276078|BG000|Baseline|AB/FF 400/12 BID|Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).
11318518|NCT03276078|FG000|Participant Flow|AB/FF 400/12 BID|Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).
11318519|NCT03276078|OG000|Outcome|AB/FF 400/12 BID|Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).
11318520|NCT03276078|EG000|Reported Event|AB/FF 400/12 BID|Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).
11318521|NCT03276494|BG000|Baseline|Intraosseous|"Administration of intraosseous hypertonic saline~Intraosseous: Intraosseous administration of hypertonic saline~Hypertonic saline: Intraosseous administration of hypertonic saline"
11318522|NCT03276494|FG000|Participant Flow|Intraosseous|"Administration of intraosseous hypertonic saline~Intraosseous: Intraosseous administration of hypertonic saline~Hypertonic saline: Intraosseous administration of hypertonic saline"
11318523|NCT03276494|OG000|Outcome|Intraosseous|"Administration of intraosseous hypertonic saline~Intraosseous: Intraosseous administration of hypertonic saline~Hypertonic saline: Intraosseous administration of hypertonic saline"
11318524|NCT03276494|EG000|Reported Event|Intraosseous|"Administration of intraosseous hypertonic saline~Intraosseous: Intraosseous administration of hypertonic saline~Hypertonic saline: Intraosseous administration of hypertonic saline"
11318525|NCT03276637|BG000|Baseline|Healthy Active-Duty Airmen Cohort|"Whole exome sequencing (WES) will be performed on 75 ostensibly healthy, active-duty Airmen (patient-participants) who receive medical care in military Primary Care, Internal Medicine and/or Family Practice settings who in their baseline survey expressed interest in receiving WES. Military healthcare providers who have received brief genomics training will return results to the patient-participants and the WES reports will be permanently integrated into their electronic medical record.~Whole exome sequencing: Whole exome sequencing at 125x coverage (i.e., at least 125 sequencing reads covering each position within the exome region of interest) performed at the Laboratory of Molecular Medicine's CLIA certified laboratory on 75 enrolled individuals"
11318526|NCT03276637|FG000|Participant Flow|Healthy Active-Duty Airmen Cohort|"Whole exome sequencing (WES) will be performed on 75 ostensibly healthy, active-duty Airmen (patient-participants) who receive medical care in military Primary Care, Internal Medicine and/or Family Practice settings who in their baseline survey expressed interest in receiving WES. Military healthcare providers who have received brief genomics training will return results to the patient-participants and the WES reports will be permanently integrated into their electronic medical record.~Whole exome sequencing: Whole exome sequencing at 125x coverage (i.e., at least 125 sequencing reads covering each position within the exome region of interest) performed at the Laboratory of Molecular Medicine's Clinical Laboratory Improvement Amendments (CLIA) certified laboratory on 75 enrolled individuals"
11318527|NCT03276637|OG000|Outcome|Healthy Active-Duty Airmen Cohort|Ostensibly healthy, active-duty Airmen who receive medical care in military Primary Care, Internal Medicine and/or Family Practice settings who in their baseline survey expressed interest in receiving exome sequencing (ES) undergo ES and have the results returned to them.
11318528|NCT03276637|OG000|Outcome|Healthy Active-Duty Airmen Cohort|"Whole exome sequencing (WES) will be performed on 75 ostensibly healthy, active-duty Airmen (patient-participants) who receive medical care in military Primary Care, Internal Medicine and/or Family Practice settings who in their baseline survey expressed interest in receiving WES. Military healthcare providers who have received brief genomics training will return results to the patient-participants and the WES reports will be permanently integrated into their electronic medical record.~Whole exome sequencing: Whole exome sequencing at 125x coverage (i.e., at least 125 sequencing reads covering each position within the exome region of interest) performed at the Laboratory of Molecular Medicine's CLIA certified laboratory on 75 enrolled individuals"
11318529|NCT03276637|EG000|Reported Event|Healthy Active-Duty Airmen Cohort|"Whole exome sequencing (WES) will be performed on 75 ostensibly healthy, active-duty Airmen (patient-participants) who receive medical care in military Primary Care, Internal Medicine and/or Family Practice settings who in their baseline survey expressed interest in receiving WES. Military healthcare providers who have received brief genomics training will return results to the patient-participants and the WES reports will be permanently integrated into their electronic medical record.~Whole exome sequencing: Whole exome sequencing at 125x coverage (i.e., at least 125 sequencing reads covering each position within the exome region of interest) performed at the Laboratory of Molecular Medicine's CLIA certified laboratory on 75 enrolled individuals"
11318530|NCT03276871|BG000|Baseline|Balloon Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.~Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector"
11318531|NCT03276871|BG001|Baseline|Telescopic Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.~Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe"
11318532|NCT03276871|BG002|Baseline|Total|Total of all reporting groups
11318533|NCT03276871|FG000|Participant Flow|Balloon Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.~Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector"
11318534|NCT03276871|FG001|Participant Flow|Telescopic Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.~Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe"
11318535|NCT03276871|OG000|Outcome|Balloon Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.~Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector"
11318536|NCT03276871|OG001|Outcome|Telescopic Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.~Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe"
11318537|NCT03276871|EG000|Reported Event|Balloon Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.~Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector"
11318538|NCT03276871|EG001|Reported Event|Telescopic Dissection|"Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.~Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe"
11318539|NCT03276975|BG000|Baseline|Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue|CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
11318540|NCT03276975|BG001|Baseline|Simulated Patching Procedure|A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
11318541|NCT03276975|BG002|Baseline|Total|Total of all reporting groups
11318542|NCT03276975|FG000|Participant Flow|Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue|CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
11318543|NCT03276975|FG001|Participant Flow|Simulated Patching Procedure|A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
11318544|NCT03276975|OG000|Outcome|Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue|CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
11318545|NCT03276975|OG001|Outcome|Simulated Patching Procedure|A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
11318546|NCT03276975|EG000|Reported Event|Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue|CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
11318547|NCT03276975|EG001|Reported Event|Simulated Patching Procedure|A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
11318548|NCT03277274|BG000|Baseline|Healthy Participants: TAK-954 0.2 mg|TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
11318549|NCT03277274|BG001|Baseline|Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318550|NCT03277274|BG002|Baseline|Group C, Severe Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318551|NCT03277274|BG003|Baseline|Total|Total of all reporting groups
11318552|NCT03277274|FG000|Participant Flow|Healthy Participants: TAK-954 0.2 mg|TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
11318553|NCT03277274|FG001|Participant Flow|Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318554|NCT03277274|FG002|Participant Flow|Group C, Severe Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318555|NCT03277274|OG000|Outcome|Healthy Participants: TAK-954 0.2 mg|TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
11318556|NCT03277274|OG001|Outcome|Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318557|NCT03277274|OG002|Outcome|Group C, Severe Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318558|NCT03277274|EG000|Reported Event|Healthy Participants: TAK-954 0.2 mg|TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.
11318559|NCT03277274|EG001|Reported Event|Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318560|NCT03277274|EG002|Reported Event|Group C, Severe Hepatic Impairment: TAK-954 0.2 mg|TAK-954 0.2 mg, infusion, intravenously, once on Day 1.
11318561|NCT03277352|BG000|Baseline|INCAGN01876 + Pembrolizumab + Epacadostat|INCAGN01876 in combination with pembrolizumab and epacadostat
11318562|NCT03277352|FG000|Participant Flow|INCAGN01876 + Pembrolizumab + Epacadostat|INCAGN01876 in combination with pembrolizumab and epacadostat
11318563|NCT03277352|OG000|Outcome|INCAGN01876 + Pembrolizumab + Epacadostat|INCAGN01876 in combination with pembrolizumab and epacadostat
11318564|NCT03277352|EG000|Reported Event|INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID|INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
11318565|NCT03277352|EG001|Reported Event|Total|Total
11318566|NCT03277378|BG000|Baseline|Group 1 (AB)|Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318567|NCT03277378|BG001|Baseline|Group 2 (TB)|Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318568|NCT03277378|BG002|Baseline|Total|Total of all reporting groups
11318569|NCT03277378|FG000|Participant Flow|Group 1 (AB)|Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318570|NCT03277378|FG001|Participant Flow|Group 2 (TB)|Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318571|NCT03277378|OG000|Outcome|Group 1 (AB)|Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318572|NCT03277378|OG001|Outcome|Group 2 (TB)|Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318573|NCT03277378|OG000|Outcome|Physicians Who Prefer Anatomic Lead Placement|Physicians who preferred anatomic placement of leads
11318574|NCT03277378|OG001|Outcome|Physicians Who Prefer Targeted Placement of Leads|Physicians who prefered targeted placement of leads
11318575|NCT03277378|OG000|Outcome|Subjects With Temporary Lead Implant|Subjects who had temporary lead implant after randomization
11318576|NCT03277378|OG001|Outcome|Subjects With Permanent Lead Implant|Subjects who had Permanent lead implant after randomization
11318577|NCT03277378|EG000|Reported Event|Group 1 (AB)|Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318578|NCT03277378|EG001|Reported Event|Group 2 (TB)|Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
11318579|NCT03277794|BG000|Baseline|Transitional Case Management Only|Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing.
11318580|NCT03277794|BG001|Baseline|Full HOP-C Service|HOP-C: Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.
11318581|NCT03277794|BG002|Baseline|Total|Total of all reporting groups
11318582|NCT03277794|FG000|Participant Flow|Transitional Case Management Only|"Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.~Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing."
11318583|NCT03277794|FG001|Participant Flow|Full HOP-C Service|"Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.~HOP-C: Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd."
11318584|NCT03277794|OG000|Outcome|Transitional Case Management Only|Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.
11318585|NCT03277794|OG001|Outcome|Full HOP-C Service|HOP-C: Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.
11318586|NCT03277794|OG000|Outcome|Transitional Case Management Only|Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing.
11318587|NCT03277794|EG000|Reported Event|Transitional Case Management Only|"Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.~Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing."
11318588|NCT03277794|EG001|Reported Event|Full HOP-C Service|"Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.~HOP-C: Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd."
11318589|NCT03277846|BG000|Baseline|Transcranial Electrical Stimulation|Transcranial Electrical Stimulation (TES). Active Treatment.
11318590|NCT03277846|BG001|Baseline|SHAM -TES|Sham/placebo condition
11318591|NCT03277846|BG002|Baseline|Total|Total of all reporting groups
11318592|NCT03277846|FG000|Participant Flow|Transcranial Electrical Stimulation (Active)|All subjects get active treatment with Transcranial Electrical Stimulation
11318593|NCT03277846|FG001|Participant Flow|TES SHAM|All subjects get SHAM treatment with TES
11318594|NCT03277846|OG000|Outcome|Transcranial Electrical Stimulation|Transcranial Electrical Stimulation (Active Tx)
11318595|NCT03277846|OG001|Outcome|TES-SHAM|SHAM treatment (no current). Otherwise procedures identical.
11318596|NCT03277846|EG000|Reported Event|Transcranial Electrical Stimulation|TES = Transcranial Electrical Stimulation (active treatment)
11318597|NCT03277846|EG001|Reported Event|SHAM-TES|TES. No current. Procedures were otherwise identical between conditions
11318598|NCT03278028|BG000|Baseline|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11318599|NCT03278028|BG001|Baseline|Vehicle|"Vehicle~A-101 Vehicle Solution: A-101 Vehicle Solution"
11318600|NCT03278028|BG002|Baseline|Total|Total of all reporting groups
11318601|NCT03278028|FG000|Participant Flow|Active|"A-101 Topical Solutions~A-101 Topical Solution: A-101 Topical Solution"
11318602|NCT03278028|FG001|Participant Flow|Vehicle|"Vehicle~A-101 Vehicle Solution: A-101 Vehicle Solution"
10827750|NCT00111800|OG005|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
11318603|NCT03278028|OG000|Outcome|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
10827751|NCT00111800|OG003|Outcome|DEN 30 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
10827752|NCT00111800|OG004|Outcome|DEN 15 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
10827753|NCT00111800|OG001|Outcome|DEN 2.5 mg|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
10827754|NCT00111800|OG000|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827755|NCT00111800|OG001|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
10827756|NCT00111800|OG002|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
10827757|NCT00111800|OG003|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
10827758|NCT00111800|OG004|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
10827759|NCT00111800|OG001|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827760|NCT00111800|EG000|Reported Event|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
10827761|NCT00111800|EG001|Reported Event|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
10827762|NCT00111800|EG002|Reported Event|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
10827763|NCT00111800|EG003|Reported Event|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
10827764|NCT00111800|EG004|Reported Event|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
10827765|NCT00111800|EG005|Reported Event|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
11318604|NCT03278028|OG001|Outcome|Vehicle|"Vehicle~A-101 Vehicle Solution: A-101 Vehicle Solution"
11318605|NCT03278028|EG000|Reported Event|Active|"A-101 Topical Solution~A-101 Topical Solution: A-101 Topical Solution"
11318606|NCT03278028|EG001|Reported Event|Vehicle|"Vehicle~A-101 Vehicle Solution: A-101 Vehicle Solution"
11318607|NCT03278067|BG000|Baseline|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
11318608|NCT03278067|BG001|Baseline|Vaccinated_Non GSK Group|Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
11318609|NCT03278067|BG002|Baseline|Vaccinated_Unknown Brand Group|Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
11318610|NCT03278067|BG003|Baseline|Total|Total of all reporting groups
11318611|NCT03278067|FG000|Participant Flow|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
11318612|NCT03278067|FG001|Participant Flow|Vaccinated_Non GSK Group|Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
11318613|NCT03278067|FG002|Participant Flow|Vaccinated_Unknown Brand Group|Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
11318614|NCT03278067|OG000|Outcome|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
11318615|NCT03278067|OG001|Outcome|Vaccinated_Non GSK Group|Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
10827766|NCT00111813|BG000|Baseline|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
11318616|NCT03278067|OG002|Outcome|Vaccinated_Unknown Brand Group|Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
11318617|NCT03278067|OG001|Outcome|2Vaccinated_Non GSK Group|Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
11318618|NCT03278067|OG002|Outcome|Vaccinated_Unknown Brand Group|Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017
11318619|NCT03278067|OG000|Outcome|Vaccinated_Fluarix Tetra Group|"Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.~Enhanced vaccine safety surveillance: Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system."
11318620|NCT03278067|OG001|Outcome|Vaccinated_Non GSK Group|"Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.~Enhanced vaccine safety surveillance: Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system."
11318621|NCT03278067|OG002|Outcome|Vaccinated_Unknown Group|"Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.~Enhanced vaccine safety surveillance: Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system."
11318622|NCT03278067|EG000|Reported Event|Vaccinated_Fluarix Tetra Group|Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
11318623|NCT03278067|EG001|Reported Event|Vaccinated_Non GSK Group|Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
11318624|NCT03278067|EG002|Reported Event|Vaccinated_Unknown Brand Group|Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
10827767|NCT00111813|FG000|Participant Flow|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
11318625|NCT03278106|BG000|Baseline|Treatment (TAS-102)|Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11318626|NCT03278106|FG000|Participant Flow|Treatment (TAS-102)|Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11318627|NCT03278106|OG000|Outcome|Treatment (TAS-102)|Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11318628|NCT03278106|EG000|Reported Event|Treatment (TAS-102)|Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally PO BID on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
11318629|NCT03278223|BG000|Baseline|Test Solution|"A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.~Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2."
11318630|NCT03278223|BG001|Baseline|Control Solution|"A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.~Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1."
11318631|NCT03278223|BG002|Baseline|Total|Total of all reporting groups
11318632|NCT03278223|FG000|Participant Flow|Test Solution|"A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.~Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2."
11318633|NCT03278223|FG001|Participant Flow|Control Solution|"A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.~Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1."
11318634|NCT03278223|OG000|Outcome|Test Solution|A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
11318635|NCT03278223|OG001|Outcome|Control Solution|A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
11318636|NCT03278223|EG000|Reported Event|Test Solution|Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
11318637|NCT03278223|EG001|Reported Event|Control Solution|Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
11318638|NCT03278613|BG000|Baseline|PTNS|"PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318639|NCT03278613|BG001|Baseline|Sham|"Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318640|NCT03278613|BG002|Baseline|Total|Total of all reporting groups
11318641|NCT03278613|FG000|Participant Flow|Percutaneous Tibial Nerve Stimulation (PTNS)|"PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318642|NCT03278613|FG001|Participant Flow|Validated Sham|"Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318643|NCT03278613|OG000|Outcome|PTNS|"PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318644|NCT03278613|OG001|Outcome|Sham|"Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318645|NCT03278613|EG000|Reported Event|PTNS|"PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11335960|NCT03559179|OG001|Outcome|Non-Waivered Providers Who Received Opioid Wizard|"All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid. This arm of providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11318646|NCT03278613|EG001|Reported Event|Sham|"Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.~ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
11318647|NCT03278886|BG000|Baseline|Low Dose Naltrexone|"Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.~Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks"
11318648|NCT03278886|BG001|Baseline|Nalmefene|"Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.~Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks"
11318649|NCT03278886|BG002|Baseline|Total|Total of all reporting groups
11318650|NCT03278886|FG000|Participant Flow|Low Dose Naltrexone|"Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.~Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks"
11318651|NCT03278886|FG001|Participant Flow|Nalmefene|"Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.~Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks"
11318652|NCT03278886|OG000|Outcome|Low Dose Naltrexone|"Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.~Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks"
11318653|NCT03278886|OG001|Outcome|Nalmefene|"Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.~Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks"
11318654|NCT03278886|EG000|Reported Event|Low Dose Naltrexone|"Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.~Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks"
11318655|NCT03278886|EG001|Reported Event|Nalmefene|"Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.~Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks"
11318656|NCT03279237|BG000|Baseline|FOLFIRINOX + Pre-operative Radiation|"FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle~Oxaliplatin is administered intravenously~Leucovorin is administered intravenously~Irinotecan is administered intravenously~5-Fluorouracil is administered intravenously~Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days~Irinotecan: May help shrink tumor before surgery.~Oxaliplatin: May help shrink tumor before surgery.~Leucovorin: May help shrink tumor before surgery.~5-Fluorouracil: May help shrink tumor before surgery.~Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading.~Radiation Therapy: May help shrink tumor.~Carboplatin: Carboplatin may stop cancer cells from growing."
11318657|NCT03279237|FG000|Participant Flow|FOLFIRINOX + Pre-operative Radiation|"FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle~Oxaliplatin is administered intravenously~Leucovorin is administered intravenously~Irinotecan is administered intravenously~5-Fluorouracil is administered intravenously~Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days~Irinotecan: May help shrink tumor before surgery.~Oxaliplatin: May help shrink tumor before surgery.~Leucovorin: May help shrink tumor before surgery.~5-Fluorouracil: May help shrink tumor before surgery.~Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading.~Radiation Therapy: May help shrink tumor.~Carboplatin: Carboplatin may stop cancer cells from growing."
11318658|NCT03279237|OG000|Outcome|FOLFIRINOX + Pre-operative Radiation|"FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle~Oxaliplatin is administered intravenously~Leucovorin is administered intravenously~Irinotecan is administered intravenously~5-Fluorouracil is administered intravenously~Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days~Irinotecan: May help shrink tumor before surgery.~Oxaliplatin: May help shrink tumor before surgery.~Leucovorin: May help shrink tumor before surgery.~5-Fluorouracil: May help shrink tumor before surgery.~Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading.~Radiation Therapy: May help shrink tumor.~Carboplatin: Carboplatin may stop cancer cells from growing."
11318659|NCT03279237|EG000|Reported Event|FOLFIRINOX + Pre-operative Radiation|"FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle~Oxaliplatin is administered intravenously~Leucovorin is administered intravenously~Irinotecan is administered intravenously~5-Fluorouracil is administered intravenously~Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days~Irinotecan: May help shrink tumor before surgery.~Oxaliplatin: May help shrink tumor before surgery.~Leucovorin: May help shrink tumor before surgery.~5-Fluorouracil: May help shrink tumor before surgery.~Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading.~Radiation Therapy: May help shrink tumor.~Carboplatin: Carboplatin may stop cancer cells from growing."
11318660|NCT03279458|BG000|Baseline|Linshom|Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
11318661|NCT03279458|FG000|Participant Flow|Linshom Respiratory Monitoring Device|Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
11335961|NCT03559179|OG002|Outcome|Did Not Receive the Opioid Wizard|All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
11335962|NCT03559179|OG000|Outcome|Waivered Providers Received the Opioid Wizard|"These providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11318662|NCT03279458|OG000|Outcome|Linshom|Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
11318663|NCT03279458|OG001|Outcome|Maquet Ventilator|Tidal volume measured by the Maquet ventilator connected to CPAP mask concurrently with Linshom
11318664|NCT03279458|EG000|Reported Event|Linshom|Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform.
11318665|NCT03279458|EG001|Reported Event|Maquet Ventilator|The tidal volume will also be measured by the maquet ventilatorconcurrently and the data downloaded in a Compact Flash card.
11318666|NCT03279731|BG000|Baseline|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.~Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved."
11318667|NCT03279731|BG001|Baseline|Placebo|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.~Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection"
11318668|NCT03279731|BG002|Baseline|Total|Total of all reporting groups
11318669|NCT03279731|FG000|Participant Flow|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.~Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved."
11318670|NCT03279731|FG001|Participant Flow|Placebo|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.~Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection"
11318671|NCT03279731|OG000|Outcome|Liraglutide|Participants randomized to liraglutide 3.0 mg/d
11318672|NCT03279731|OG001|Outcome|Placebo|Participants randomized to placebo
11318673|NCT03279731|OG000|Outcome|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.~Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved."
11318674|NCT03279731|OG001|Outcome|Placebo|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.~Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection"
11335963|NCT03559179|OG001|Outcome|Non-Waivered Providers Who Receive the Opioid Wizard|"Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents non-waivered providers who received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
10827768|NCT00111813|FG001|Participant Flow|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
11318675|NCT03279731|EG000|Reported Event|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.~Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved."
11318676|NCT03279731|EG001|Reported Event|Placebo|"Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.~Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection"
11318677|NCT03280108|BG000|Baseline|TFNT00|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318678|NCT03280108|BG001|Baseline|SN60AT|AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318679|NCT03280108|BG002|Baseline|Total|Total of all reporting groups
11318680|NCT03280108|FG000|Participant Flow|TFNT00|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318681|NCT03280108|FG001|Participant Flow|SN60AT|AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318682|NCT03280108|OG000|Outcome|TFNT00|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318683|NCT03280108|OG001|Outcome|SN60AT|AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
11318684|NCT03280108|EG000|Reported Event|Preoperative|All subjects in the safety analysis set prior to initiation of treatment.
11318685|NCT03280108|EG001|Reported Event|TFNT00 - 1st Eye|All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.
11318686|NCT03280108|EG002|Reported Event|TFNT00 - 2nd Eye|All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.
11318687|NCT03280108|EG003|Reported Event|TFNT00 - Systemic|All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.
11318688|NCT03280108|EG004|Reported Event|SN60AT - 1st Eye|All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT.
11318689|NCT03280108|EG005|Reported Event|SN60AT - 2nd Eye|All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT.
11318690|NCT03280108|EG006|Reported Event|SN60AT - Systemic|All subjects implanted with AcrySof Monofocal IOL Model SN60AT.
11318691|NCT03280121|BG000|Baseline|TIF Using EsophyX ZR Transoral Device|"Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device~EsophyX ZR transoral device: TIF"
11318692|NCT03280121|FG000|Participant Flow|TIF Using EsophyX ZR Transoral Device|Prospective, investigator initiated, multicenter, non-randomized single arm, open label
11318693|NCT03280121|OG000|Outcome|TIF Using EsophyX ZR Transoral Device-(SINGLE ARM)|"Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device~EsophyX ZR transoral device: TIF"
11318694|NCT03280121|EG000|Reported Event|EsophyX ZR Transoral Device|Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device with Hiatal hernias ≤ 2 and > 4 cm.
11318695|NCT03280264|BG000|Baseline|KHK7580 (2-24 mg)|KHK7580 was orally administered daily for up to week 52.
11318696|NCT03280264|FG000|Participant Flow|KHK7580 (2-24 mg)|KHK7580 was orally administered daily for up to week 52.
11318697|NCT03280264|OG000|Outcome|KHK7580 (2-24 mg)|KHK7580 was orally administered daily for up to week 52.
11318698|NCT03280264|OG000|Outcome|KHK7580 (2-24 mg)|KHK7580 was orally administered daily.
11318699|NCT03280264|EG000|Reported Event|KHK7580 (2-24 mg)|KHK7580 was orally administered daily for up to week 52.
11333346|NCT03512067|EG000|Reported Event|Patients Given EMV Ventilation|Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
11333347|NCT03512288|BG000|Baseline|20vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
10827769|NCT00111813|FG002|Participant Flow|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11318700|NCT03280381|BG000|Baseline|NIFTY Feeding Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318701|NCT03280381|BG001|Baseline|Generic Medicine Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318702|NCT03280381|BG002|Baseline|Total|Total of all reporting groups
11318703|NCT03280381|FG000|Participant Flow|NIFTY Feeding Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318704|NCT03280381|FG001|Participant Flow|Generic Medicine Cup First|"Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318705|NCT03280381|OG000|Outcome|NIFTY Feeding Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318706|NCT03280381|OG001|Outcome|Generic Medicine Cup First|"Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318707|NCT03280381|OG001|Outcome|Generic Medicine Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318708|NCT03280381|EG000|Reported Event|NIFTY Feeding Cup First|"Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318709|NCT03280381|EG001|Reported Event|Generic Medicine Cup First|"Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.~Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.~Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties."
11318710|NCT03280537|BG000|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318711|NCT03280537|BG001|Baseline|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318712|NCT03280537|BG002|Baseline|Total|Total of all reporting groups
11318713|NCT03280537|FG000|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318714|NCT03280537|FG001|Participant Flow|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318715|NCT03280537|OG000|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318716|NCT03280537|OG001|Outcome|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318717|NCT03280537|EG000|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318718|NCT03280537|EG001|Reported Event|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318719|NCT03280550|BG000|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318720|NCT03280550|BG001|Baseline|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318721|NCT03280550|BG002|Baseline|Total|Total of all reporting groups
11318722|NCT03280550|FG000|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
10827770|NCT00111813|FG003|Participant Flow|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11318723|NCT03280550|FG001|Participant Flow|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
10827771|NCT00111813|FG004|Participant Flow|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11318724|NCT03280550|OG000|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318725|NCT03280550|OG001|Outcome|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318726|NCT03280550|EG000|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318727|NCT03280550|EG001|Reported Event|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
11318728|NCT03280615|BG000|Baseline|Omega 3 Fatty Acids|"Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks~Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids"
11318729|NCT03280615|BG001|Baseline|Corn Oil|"Supplementation of 3.7 g of corn oil per day during 12 weeks~Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement"
11318730|NCT03280615|BG002|Baseline|Total|Total of all reporting groups
11318731|NCT03280615|FG000|Participant Flow|Omega 3 Fatty Acids|"Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks~Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids"
11318732|NCT03280615|FG001|Participant Flow|Corn Oil|"Supplementation of 3.7 g of corn oil per day during 12 weeks~Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement"
10827772|NCT00111813|FG005|Participant Flow|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11318733|NCT03280615|OG000|Outcome|Omega 3 Fatty Acids|"Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks~Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids"
11318734|NCT03280615|OG001|Outcome|Corn Oil|"Supplementation of 3.7 g of corn oil per day during 12 weeks~Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement"
11318735|NCT03280615|EG000|Reported Event|Omega 3 Fatty Acids|"Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks~Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids"
11318736|NCT03280615|EG001|Reported Event|Corn Oil|"Supplementation of 3.7 g of corn oil per day during 12 weeks~Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement"
11318737|NCT03281200|BG000|Baseline|Total Patients With IPF|The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
11318738|NCT03281200|FG000|Participant Flow|Total Patients With IPF|The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
11318739|NCT03281200|OG000|Outcome|Total Patients With IPF|The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
11318740|NCT03281200|EG000|Reported Event|Total Patients With IPF|The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
11318741|NCT03281538|BG000|Baseline|CR845 0.5mcg/kg|"CR845 0.5mcg/kg IV medication administered three times/week after dialysis~CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)"
11318742|NCT03281538|FG000|Participant Flow|CR845 0.5mcg/kg|"CR845 0.5mcg/kg IV medication administered three times/week after dialysis~CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)"
11318743|NCT03281538|OG000|Outcome|CR845 0.5mcg/kg|"CR845 0.5mcg/kg IV medication administered three times/week after dialysis~CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)"
11318744|NCT03281538|EG000|Reported Event|CR845 0.5mcg/kg|"CR845 0.5mcg/kg IV medication administered three times/week after dialysis~CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)"
11318745|NCT03281577|BG000|Baseline|Placebo|TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
11318746|NCT03281577|BG001|Baseline|TAK-954 0.1 mg|TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318747|NCT03281577|BG002|Baseline|TAK-954 0.3 mg|TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318748|NCT03281577|BG003|Baseline|TAK-954 1 mg|TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318749|NCT03281577|BG004|Baseline|Total|Total of all reporting groups
11318750|NCT03281577|FG000|Participant Flow|Placebo|TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.
11318751|NCT03281577|FG001|Participant Flow|TAK-954 0.1 mg|TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318752|NCT03281577|FG002|Participant Flow|TAK-954 0.3 mg|TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318753|NCT03281577|FG003|Participant Flow|TAK-954 1 mg|TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318754|NCT03281577|OG000|Outcome|Placebo|TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
11318755|NCT03281577|OG001|Outcome|TAK-954 0.1 mg|TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318756|NCT03281577|OG002|Outcome|TAK-954 0.3 mg|TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318757|NCT03281577|OG003|Outcome|TAK-954 1 mg|TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318758|NCT03281577|OG000|Outcome|TAK-954 0.1 mg|TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318759|NCT03281577|OG001|Outcome|TAK-954 0.3 mg|TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318760|NCT03281577|OG002|Outcome|TAK-954 1 mg|TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318761|NCT03281577|EG000|Reported Event|Placebo|TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
11318762|NCT03281577|EG001|Reported Event|TAK-954 0.1 mg|TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318763|NCT03281577|EG002|Reported Event|TAK-954 0.3 mg|TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318764|NCT03281577|EG003|Reported Event|TAK-954 1 mg|TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
11318765|NCT03281668|BG000|Baseline|Intervention|"Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.~High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods."
11318766|NCT03281668|FG000|Participant Flow|Intervention|"Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.~High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods."
11318767|NCT03281668|OG000|Outcome|Intervention|"Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.~High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods."
11318768|NCT03281668|EG000|Reported Event|Intervention|"Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.~High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods."
11318769|NCT03281876|BG000|Baseline|GSK3277511A Group|Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61
11318770|NCT03281876|BG001|Baseline|Control Group|Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
11318771|NCT03281876|BG002|Baseline|Total|Total of all reporting groups
11318772|NCT03281876|FG000|Participant Flow|GSK3277511A Group|Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61
11318773|NCT03281876|FG001|Participant Flow|Control Group|Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
11318774|NCT03281876|OG000|Outcome|GSK3277511A Group|Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61
11318775|NCT03281876|OG001|Outcome|Control Group|Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
11318776|NCT03281876|EG000|Reported Event|GSK3277511A Group|Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61
11318777|NCT03281876|EG001|Reported Event|Control Group|Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
11333348|NCT03512288|BG001|Baseline|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
11333349|NCT03512288|BG002|Baseline|Total|Total of all reporting groups
11318778|NCT03282071|BG000|Baseline|Joyful Parenting Intervention|"Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).~After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents."
11318779|NCT03282071|BG001|Baseline|Control|No intervention were provided to control groups during study period.
11318780|NCT03282071|BG002|Baseline|Total|Total of all reporting groups
11318781|NCT03282071|FG000|Participant Flow|Joyful Parenting Intervention|"Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).~After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents."
11318782|NCT03282071|FG001|Participant Flow|Control|No intervention were provided to control groups during assessment period.
11318783|NCT03282071|OG000|Outcome|Joyful Parenting Intervention|"Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).~After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents."
11318784|NCT03282071|OG001|Outcome|Control|No intervention will be provided to control groups during study period.
11318785|NCT03282071|OG001|Outcome|Control|No intervention will be provided to control groups during assessment period.
11318786|NCT03282071|OG001|Outcome|Control|No intervention were provided to control groups during study period.
11318787|NCT03282071|EG000|Reported Event|Joyful Parenting Intervention|"Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).~After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents."
11318788|NCT03282071|EG001|Reported Event|Control|No intervention will be provided to control groups during study period.
11318789|NCT03282227|BG000|Baseline|M207 Microneedle System 3.8 mg|"M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)~M207 Microneedle System: M207 Microneedle System 3.8 mg"
11318790|NCT03282227|FG000|Participant Flow|M207 Microneedle System 3.8 mg|"M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)~M207 Microneedle System: M207 Microneedle System 3.8 mg"
11318791|NCT03282227|OG000|Outcome|M207 Microneedle System 3.8 mg|"M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)~M207 Microneedle System: M207 Microneedle System 3.8 mg"
11318792|NCT03282227|EG000|Reported Event|M207 Microneedle System 3.8 mg|"M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)~M207 Microneedle System: M207 Microneedle System 3.8 mg"
11318793|NCT03282357|BG000|Baseline|Radiesse and Restylane|Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
11318794|NCT03282357|FG000|Participant Flow|Radiesse and Restylane|Participants received split-face nasolabial fold (NLF) treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
11318795|NCT03282357|OG000|Outcome|Radiesse|All participants received NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs on Day 1. Participants received an optional touch-up injection in the same NLF at Month 1.
11318796|NCT03282357|OG001|Outcome|Restylane|All participants received NLF treatment with control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in the same NLFs at Month 1.
11318797|NCT03282357|EG000|Reported Event|Radiesse and Restylane|Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
11318798|NCT03282591|BG000|Baseline|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318799|NCT03282591|BG001|Baseline|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318800|NCT03282591|BG002|Baseline|Total|Total of all reporting groups
11318801|NCT03282591|FG000|Participant Flow|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318802|NCT03282591|FG001|Participant Flow|Placebo|Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318803|NCT03282591|OG000|Outcome|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318804|NCT03282591|OG001|Outcome|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318805|NCT03282591|OG001|Outcome|Placebo|Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318806|NCT03282591|EG000|Reported Event|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11318807|NCT03282591|EG001|Reported Event|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
11333350|NCT03512288|FG000|Participant Flow|20vPnC|Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
11318808|NCT03282682|BG000|Baseline|Hypogonadal Males Without TRT|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318809|NCT03282682|BG001|Baseline|Hypogonadal Males With TRT|"Strength training and regular prescribed testosterone therapy given by participant urologist.~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318810|NCT03282682|BG002|Baseline|Healthy Eugonadal Males|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318811|NCT03282682|BG003|Baseline|Total|Total of all reporting groups
11318812|NCT03282682|FG000|Participant Flow|Hypogonadal Males Without TRT|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318813|NCT03282682|FG001|Participant Flow|Hypogonadal Males With TRT|"Strength training and regular prescribed testosterone therapy given by participant urologist.~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318814|NCT03282682|FG002|Participant Flow|Healthy Eugonadal Males|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318815|NCT03282682|OG000|Outcome|Hypogonadal Males Without TRT|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318816|NCT03282682|OG001|Outcome|Hypogonadal Males With TRT|"Strength training and regular prescribed testosterone therapy given by participant urologist.~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11333351|NCT03512288|FG001|Participant Flow|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
11333352|NCT03512288|OG000|Outcome|20vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
11335964|NCT03559179|OG002|Outcome|Non-Waivered Providers Who do Not Receive the Opioid Wizard|These are non-buprenorphine waivered providers continued to treat their patients as usual.
11318817|NCT03282682|OG002|Outcome|Healthy Eugonadal Males|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318818|NCT03282682|EG000|Reported Event|Hypogonadal Males Without TRT|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318819|NCT03282682|EG001|Reported Event|Hypogonadal Males With TRT|"Strength training and regular prescribed testosterone therapy given by participant urologist.~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318820|NCT03282682|EG002|Reported Event|Healthy Eugonadal Males|"Strength training~Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press."
11318821|NCT03283098|BG000|Baseline|Placebo|Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks.
11318822|NCT03283098|BG001|Baseline|Etelcalcetide|5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks.
11318823|NCT03283098|BG002|Baseline|Total|Total of all reporting groups
11318824|NCT03283098|FG000|Participant Flow|Placebo|Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks.
11318825|NCT03283098|FG001|Participant Flow|Etelcalcetide|5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks.
11318826|NCT03283098|OG000|Outcome|Placebo|Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks.
11318827|NCT03283098|OG001|Outcome|Etelcalcetide|5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks.
11318828|NCT03283098|EG000|Reported Event|Placebo|Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks.
11318829|NCT03283098|EG001|Reported Event|Etelcalcetide|5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks.
11318830|NCT03283319|BG000|Baseline|3.75 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
11318831|NCT03283319|BG001|Baseline|7.5 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
11318832|NCT03283319|BG002|Baseline|15 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
11318833|NCT03283319|BG003|Baseline|3.75 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
11318834|NCT03283319|BG004|Baseline|7.5 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
11318835|NCT03283319|BG005|Baseline|15 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
11318836|NCT03283319|BG006|Baseline|Total|Total of all reporting groups
11318837|NCT03283319|FG000|Participant Flow|3.75 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
11318838|NCT03283319|FG001|Participant Flow|7.5 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
11318839|NCT03283319|FG002|Participant Flow|15 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
11318840|NCT03283319|FG003|Participant Flow|3.75 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
11318841|NCT03283319|FG004|Participant Flow|7.5 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
11318842|NCT03283319|FG005|Participant Flow|15 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
11318843|NCT03283319|OG000|Outcome|3.75 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
11318844|NCT03283319|OG001|Outcome|7.5 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
11318845|NCT03283319|OG002|Outcome|15 µg Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
11318846|NCT03283319|OG000|Outcome|3.75 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
11318847|NCT03283319|OG001|Outcome|7.5 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
11318848|NCT03283319|OG002|Outcome|15 µg Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
11318849|NCT03283319|EG000|Reported Event|3.75 ug Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03
11318850|NCT03283319|EG001|Reported Event|7.5 ug Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03
11318851|NCT03283319|EG002|Reported Event|15 ug Panblok H7 Plus AS03|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03
11318852|NCT03283319|EG003|Reported Event|3.75 ug Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59
11318853|NCT03283319|EG004|Reported Event|7.5 ug Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59
11318854|NCT03283319|EG005|Reported Event|15 ug Panblok H7 Plus MF59|Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59
11318855|NCT03283436|BG000|Baseline|Superior Hypogastric Plexus Block|"Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.~Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)"
11318856|NCT03283436|BG001|Baseline|No Block|Patients in the control arm will undergo the hysterectomy with no intervention.
11318857|NCT03283436|BG002|Baseline|Total|Total of all reporting groups
11318858|NCT03283436|FG000|Participant Flow|Superior Hypogastric Plexus Block|"Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.~Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)"
11318859|NCT03283436|FG001|Participant Flow|No Block|Patients in the control arm will undergo the hysterectomy with no intervention.
11318860|NCT03283436|OG000|Outcome|Superior Hypogastric Plexus Block|"Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.~Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)"
11318861|NCT03283436|OG001|Outcome|No Block|Patients in the control arm will undergo the hysterectomy with no intervention.
11318862|NCT03283436|EG000|Reported Event|Superior Hypogastric Plexus Block|"Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.~Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)"
11318863|NCT03283436|EG001|Reported Event|No Block|Patients in the control arm will undergo the hysterectomy with no intervention.
11318864|NCT03283553|BG000|Baseline|Multicomponent Intervention|1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
11318865|NCT03283553|BG001|Baseline|Usual Care|Care as usual with the medical oncologist.
11318866|NCT03283553|BG002|Baseline|Total|Total of all reporting groups
11318867|NCT03283553|FG000|Participant Flow|Multicomponent Intervention|1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
11318868|NCT03283553|FG001|Participant Flow|Usual Care|Care as usual with the medical oncologist.
11318869|NCT03283553|OG000|Outcome|Multicomponent Intervention|1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
11318870|NCT03283553|OG001|Outcome|Usual Care|Care as usual with the medical oncologist.
11318871|NCT03283553|OG000|Outcome|Multicomponent Intervention|"1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.~Checklist, MyChart, OpenNotes: 1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes."
11318872|NCT03283553|OG001|Outcome|Usual Care|"Care as usual with the medical oncologist.~Usual Care: Routine medical oncology care"
11318873|NCT03283553|EG000|Reported Event|Multicomponent Intervention|1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
11318874|NCT03283553|EG001|Reported Event|Usual Care|Care as usual with the medical oncologist.
11318875|NCT03283696|BG000|Baseline|Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318876|NCT03283696|BG001|Baseline|Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318877|NCT03283696|BG002|Baseline|Total|Total of all reporting groups
11318878|NCT03283696|FG000|Participant Flow|Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus doxorubicin 25 milligrams per meter square (mg/m^2) on days 1, 2, 3 plus ifosfamide 2.5 gram per meter square (g/m^2) per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318879|NCT03283696|FG001|Participant Flow|Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318880|NCT03283696|OG000|Outcome|Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318881|NCT03283696|OG001|Outcome|Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318882|NCT03283696|EG000|Reported Event|Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318883|NCT03283696|EG001|Reported Event|Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide|Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously.
11318884|NCT03283787|BG000|Baseline|Group 1|MicroMatrix® and Cytal™ Wound Matrix 2-Layer
11318885|NCT03283787|BG001|Baseline|Group 2|MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
11318886|NCT03283787|BG002|Baseline|Group 3|Negative Pressure Wound Therapy
11318887|NCT03283787|BG003|Baseline|Total|Total of all reporting groups
11318888|NCT03283787|FG000|Participant Flow|MicroMatrix® and Cytal™ Wound Matrix 2-Layer|Treatment protocol per PI SOC discretion utilizing study devices.
11318889|NCT03283787|FG001|Participant Flow|MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT|Treatment protocol per PI SOC discretion utilizing study device plus NPWT.
11318890|NCT03283787|FG002|Participant Flow|Negative Pressure Wound Therapy|Treatment protocol per PI SOC discretion.
10827773|NCT00111813|OG000|Outcome|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
11318891|NCT03283787|OG000|Outcome|MicroMatrix® and Cytal™ Wound Matrix 2-Layer|Treatment protocol per PI discretion
11318892|NCT03283787|OG001|Outcome|MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT|Treatment protocol per PI discretion
11318893|NCT03283787|OG002|Outcome|Negative Pressure Wound Therapyroup 3|Treatment protocol per PI discretion
11318894|NCT03283787|OG000|Outcome|Group 1|MicroMatrix® and Cytal™ Wound Matrix 2-Layer
11318895|NCT03283787|OG001|Outcome|Group 2|MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
11318896|NCT03283787|OG002|Outcome|Group 3|Negative Pressure Wound Therapy
11318897|NCT03283787|EG000|Reported Event|Group 1|MicroMatrix® and Cytal™ Wound Matrix 2-Layer
11318898|NCT03283787|EG001|Reported Event|Group 2|MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
11318899|NCT03283787|EG002|Reported Event|Group 3|Negative Pressure Wound Therapy
11318900|NCT03284229|BG000|Baseline|Enrolled|Enrolled Patients
11318901|NCT03284229|FG000|Participant Flow|Enrolled|Excimer Laser Coronary Atherectomy (ELCA) Enrolled Patients
11318902|NCT03284229|OG000|Outcome|Enrolled|Enrolled Patients
11318903|NCT03284229|OG000|Outcome|Enrolled|Enrolled Patients, including Lost To Follow Up
11318904|NCT03284229|EG000|Reported Event|Enrolled|Enrolled Patients, including LTFU
11318905|NCT03284359|BG000|Baseline|Pre-Consent Nudge Bundle|"Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.~Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement."
11318906|NCT03284359|BG001|Baseline|Standard Consent|Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.
11318907|NCT03284359|BG002|Baseline|Total|Total of all reporting groups
11318908|NCT03284359|FG000|Participant Flow|Pre-Consent Nudge Bundle|"Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.~Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement."
11318909|NCT03284359|FG001|Participant Flow|Standard Consent|Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.
11318910|NCT03284359|OG000|Outcome|Pre-Consent Nudge Bundle|"Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.~Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement."
11318911|NCT03284359|OG001|Outcome|Standard Consent|Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.
10827774|NCT00111813|OG000|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
11333353|NCT03512288|OG001|Outcome|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
11318912|NCT03284359|EG000|Reported Event|Pre-Consent Nudge Bundle|"Arm 1 will be administered a novel pre-consent nudge bundle which incorporates several behavioral economic interventions within a brief survey. Participants will subsequently be asked by the same research personnel to participate in a simulated randomized control trial (RCT) comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive the standard consent form followed by a risk assessment and demographic survey.~Pre-Consent Nudge Bundle: The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement."
11318913|NCT03284359|EG001|Reported Event|Standard Consent|Arm 2 will serve as the control arm. Participants will be approached by the research personnel to participate in a simulated RCT comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. Participants will receive a standard consent form as detailed in the Study Instruments section. Following the consent process participants will conduct the same risk assessment survey and demographic survey.
11318914|NCT03284398|BG000|Baseline|Three-Chambered Bag (3CB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).
11318915|NCT03284398|BG001|Baseline|Hospital-compounded Bag (HCB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).
11318916|NCT03284398|BG002|Baseline|Total|Total of all reporting groups
11318917|NCT03284398|FG000|Participant Flow|Three-chambered Bag (3CB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period
11318918|NCT03284398|FG001|Participant Flow|Hospital-Compounded Bag (HCB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via a Hospital-compounded all-in-one PN bag for ≥3 consecutive days during the study period
11318919|NCT03284398|OG000|Outcome|Three-Chambered Bag|Treatment with industrially-compounded PN formulation in three-chambered bag
11318920|NCT03284398|OG001|Outcome|Hospital-compounded Bag|Treatment with Hospital-compounded PN bag
11318921|NCT03284398|OG000|Outcome|Three-Chambered Bag (3CB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period
11318922|NCT03284398|OG001|Outcome|Hospital-Compounded Bag (HCB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).
11318923|NCT03284398|OG000|Outcome|Three-chambered Bag (3CB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period
11318924|NCT03284398|OG001|Outcome|Hospital-Compounded Bag (HCB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via a Hospital-compounded all-in-one PN bag for ≥3 consecutive days during the study period
11318925|NCT03284398|OG000|Outcome|Three-Chambered Bag (3CB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).
11318926|NCT03284398|OG001|Outcome|Hospital-compounded Bag (HCB)|Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).
11318927|NCT03284398|EG000|Reported Event|Three-Chambered Bag (3CB)|Not applicable (Observational/non-interventional retrospective data collection)
11318928|NCT03284398|EG001|Reported Event|Hospital-compounded Bag (HCB)|Not applicable (Observational/non-interventional retrospective data collection)
11318929|NCT03284411|BG000|Baseline|Spinal Cord Stimulation|"Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold).~Spinal Cord Stimulation: Programming"
11318930|NCT03284411|FG000|Participant Flow|Spinal Cord Stimulation|"Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold amplitude).~Spinal Cord Stimulation: Programming"
11318931|NCT03284411|OG000|Outcome|Spinal Cord Stimulation|"Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of perception threshold).~Spinal Cord Stimulation: Programming"
11318932|NCT03284411|OG000|Outcome|Spinal Cord Stimulation|"Each subject was programmed to 4 different amplitude settings (80, 60, 40, 20 percent of perception threshold).~Spinal Cord Stimulation: Programming"
11318933|NCT03284411|EG000|Reported Event|Spinal Cord Stimulation|"Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold)~Spinal Cord Stimulation: Programming"
11318934|NCT03284424|BG000|Baseline|Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle.
11318935|NCT03284424|BG001|Baseline|Locally Advanced Unresectable cSCC Cohort|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
11318936|NCT03284424|BG002|Baseline|Total|Total of all reporting groups
11318937|NCT03284424|FG000|Participant Flow|Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort|Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle.
11318938|NCT03284424|FG001|Participant Flow|Locally Advanced Unresectable cSCC Cohort|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
11318939|NCT03284424|OG000|Outcome|Recurrent or Metastatic cSCC Cohort|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
11318940|NCT03284424|OG001|Outcome|Locally Advanced Unresectable cSCC Cohort|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
11318941|NCT03284424|EG000|Reported Event|Pembrolizumab 200 mg|Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
11318942|NCT03284710|BG000|Baseline|Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) gp120/MF59 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318943|NCT03284710|BG001|Baseline|Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318944|NCT03284710|BG002|Baseline|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318945|NCT03284710|BG003|Baseline|Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318946|NCT03284710|BG004|Baseline|Total|Total of all reporting groups
11318947|NCT03284710|FG000|Participant Flow|Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318948|NCT03284710|FG001|Participant Flow|Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318949|NCT03284710|FG002|Participant Flow|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318950|NCT03284710|FG003|Participant Flow|Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318951|NCT03284710|OG000|Outcome|Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318952|NCT03284710|OG001|Outcome|Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318953|NCT03284710|OG001|Outcome|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318954|NCT03284710|OG002|Outcome|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318955|NCT03284710|OG003|Outcome|Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318956|NCT03284710|OG000|Outcome|Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) gp120/MF59 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59® (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11333354|NCT03512288|EG000|Reported Event|20vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively).
11318957|NCT03284710|OG001|Outcome|Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) gp120+Alum mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318958|NCT03284710|OG002|Outcome|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)p120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59® (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318959|NCT03284710|OG003|Outcome|Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) gp120 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318960|NCT03284710|EG000|Reported Event|Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318961|NCT03284710|EG001|Reported Event|Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318962|NCT03284710|EG002|Reported Event|Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
11318963|NCT03284710|EG003|Reported Event|Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12)|ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12
11318964|NCT03285061|BG000|Baseline|Standard Disposal Instructions|These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
11318965|NCT03285061|BG001|Baseline|At Home Disposal|"With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.~Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems."
11318966|NCT03285061|BG002|Baseline|Total|Total of all reporting groups
11318967|NCT03285061|FG000|Participant Flow|Standard Disposal Instructions|These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
11318968|NCT03285061|FG001|Participant Flow|At Home Disposal|"With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.~Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems."
11318969|NCT03285061|OG000|Outcome|Standard Disposal Instructions|These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
11318970|NCT03285061|OG001|Outcome|At Home Disposal|"With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.~Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems."
11318971|NCT03285061|EG000|Reported Event|Standard Disposal Instructions|These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
11318972|NCT03285061|EG001|Reported Event|At Home Disposal|"With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.~Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems."
11318973|NCT03285113|BG000|Baseline|Ultrahigh Frequency Stimulation|"Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.~GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11318974|NCT03285113|FG000|Participant Flow|Ultrahigh Frequency Stimulation|"Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.~GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11318975|NCT03285113|OG000|Outcome|Ultrahigh Frequency Stimulation|"Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.~GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11318976|NCT03285113|EG000|Reported Event|Ultrahigh Frequency Stimulation|"Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.~GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11318977|NCT03285295|BG000|Baseline|Specificity|US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.
11318978|NCT03285295|BG001|Baseline|Sensitivity|Specimens characterized as positive obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.
11318979|NCT03285295|BG002|Baseline|Increased Risk Population|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV, HTLV I/II, HCV, and HIV infection.
11318980|NCT03285295|BG003|Baseline|Endemic Population|Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II, HIV, and Chagas endemic areas.
11318981|NCT03285295|BG004|Baseline|HBV Recovered Population|Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.
11318982|NCT03285295|BG005|Baseline|Total|Total of all reporting groups
11318983|NCT03285295|FG000|Participant Flow|Specificity|US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.
11318984|NCT03285295|FG001|Participant Flow|Sensitivity|Specimens characterized as positive obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays.
11318985|NCT03285295|FG002|Participant Flow|Increased Risk Population|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV, HTLV I/II, HCV, and HIV infection.
11318986|NCT03285295|FG003|Participant Flow|Endemic Population|Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II, HIV, and Chagas endemic area.
11318987|NCT03285295|FG004|Participant Flow|HBV Recovered Population|Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.
11318988|NCT03285295|OG000|Outcome|Alinity s HBsAg Assay Specificity|US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s assay.
11318989|NCT03285295|OG000|Outcome|Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity|Preselected HBsAg positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory assays. This population included individuals with acute hepatitis B infection, and individuals with chronic hepatitis B infection. HBV classification was determined using 4 HBV reference marker testing or medically diagnosed.
11318990|NCT03285295|OG000|Outcome|Alinity s HTLV I/II Assay Specificity|US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HTLV I/II assay.
11318991|NCT03285295|OG000|Outcome|Alinity s HTLV I/II Assay Sensitivity|"This population includes both archived and leftover not individually identifiable specimens that are extensively characterized. The specimens were confirmed positive by research use only HTLV-I Western blot and HTLV-I and HTLV-II radioimmunoprecipitation assay (RIPA) and typed as HTLV-I or HTLV-II by immunofluorescence assay (IFA) titration.~Individuals with HTLV-I/II Associated Diseases includes specimens prospectively collected from individuals diagnosed with adult T-cell leukemia/lymphoma (ATL) or HTLV-I associated myelopathy/tropical spastic paraparesis (HAM/TSP) using IRB-approved protocols sponsored by specimen vendors."
11318992|NCT03285295|OG000|Outcome|Alinity s Anti-HCV Assay Specificity|US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HCV assay.
11318993|NCT03285295|OG000|Outcome|Alinity s Anti-HCV Assay Sensitivity|This population includes specimens prospectively collected using IRB-approved protocols sponsored by Abbott Laboratories and vendor-collected leftover specimens that were not individually identifiable. A subset of these specimens was confirmed positive by an HCV recombinant immunoblot assay (RIBA). The remaining specimens were collected from subjects with a medical diagnosis of chronic HCV infection and history of greater than 6 months of HCV RNA/anti-HCV positivity. For these specimens, a current anti-HCV result was obtained.
11318994|NCT03285295|OG000|Outcome|Alinity s HIV Ag/Ab Combo Assay Specificity|US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HIV Ag/Ab Combo assay.
11318995|NCT03285295|OG000|Outcome|Alinity s HIV Ag/Ab Combo Assay Sensitivity|Preselected HIV-1/2 positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HIV Ag/Ab Combo assays. This population included individuals with HIV-1 and HIV-2 infection. The HIV-1 specimens were confirmed positive by HIV-1 Western blot and categorized by revised surveillance case definitions for HIV infection (2008) as stage 1 (n=488), stage 2 (n=427) or stage 3 (n=101) using CD4 counts and associated diagnosis. The specimens were confirmed positive for HIV-2 by HIV-2 Western blot and typed as HIV-2 only by Bio-Rad Multispot HIV-1/HIV-2 Rapid Test.The remaining are for Anti-HIV 2 (n=232), HIV-1 antigen (n=35), and HIV-1 viral isolates (n=53).
11318996|NCT03285295|OG000|Outcome|Alinity s Anti-HBc Assay Specificity|US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HBc assay.
11318997|NCT03285295|OG000|Outcome|Alinity s Anti-HBc Assay Sensitivity|Preselected Anti-HBc Positive specimens were obtained from individuals with acute hepatitis B infection, individuals with chronic hepatitis B infection, and individuals with recovered hepatitis B infection.
11318998|NCT03285295|OG000|Outcome|Alinity s Chagas Assay Specificity|US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Chagas assay.
11318999|NCT03285295|OG000|Outcome|Alinity s Chagas Assay Sensitivity|Preselected T cruzi Parasitology Positive (n = 112) and preselected T cruzi Serology Positive (n = 208) samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s Chagas assay.
11319000|NCT03285295|OG000|Outcome|Alinity s HBsAg Assay Increased Risk of HBV Infection|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV infection.
11319001|NCT03285295|OG000|Outcome|Alinity s HBsAg Assay Recovered HBV Infection|Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay.
11319002|NCT03285295|OG000|Outcome|Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HTLV I/II infection.
11319003|NCT03285295|OG000|Outcome|Alinity s HTLV I/II Assay Endemics|Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II endemic area.
11319004|NCT03285295|OG000|Outcome|Alinity s Anti-HCV Assay Increased Risk for HCV|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HCV infection.
11319005|NCT03285295|OG000|Outcome|Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HIV infection.
11319006|NCT03285295|OG000|Outcome|Alinity s HIV Ag/Ab Combo Assay Endemics|Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HIV endemic area.
11319007|NCT03285295|OG000|Outcome|Alinity s Anti-HBc Assay Increased Risk for HBV|Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV infection
11319008|NCT03285295|OG000|Outcome|Alinity s Chagas Assay Endemics|Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in Chagas endemic area.
11319009|NCT03285295|EG000|Reported Event|Alinity s HBsAg Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~No donors required for follow-up collection for Alinity s HBsAg study."
11319010|NCT03285295|EG001|Reported Event|Alinity s HTLV I/II Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~12 donors were eligible for follow-up collection for Alinity s HTLV I/II study. 8 out of 12 were able to provide follow-up specimen."
11319011|NCT03285295|EG002|Reported Event|Alinity s Anti-HCV Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~20 donors were eligible for follow-up collection for Alinity s Anti-HCV study. 2 out of 20 were able to provide follow-up specimen."
11319012|NCT03285295|EG003|Reported Event|Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~15 donors were eligible for follow-up collection for Alinity s HIV Ag/Ab Combo study.~4 out of 15 were able to provide follow-up specimen."
11333355|NCT03512288|EG001|Reported Event|13vPnC|Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
11319013|NCT03285295|EG004|Reported Event|Alinity s Anti-HBc Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~16 donors were eligible for follow-up collection for Alinity s Anti-HBc study. 2 out of 16 were able to provide follow-up specimen."
11319014|NCT03285295|EG005|Reported Event|Alinity s Chagas Follow-Up Specimen Collection|"For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.~14 donors were eligible for follow-up collection for Alinity s Chagas study.~1 out of 14 were able to provide follow-up specimen."
11319015|NCT03285308|BG000|Baseline|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11319016|NCT03285308|BG001|Baseline|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11319017|NCT03285308|BG002|Baseline|Total|Total of all reporting groups
11319018|NCT03285308|FG000|Participant Flow|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11319019|NCT03285308|FG001|Participant Flow|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11319020|NCT03285308|OG000|Outcome|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11319021|NCT03285308|OG001|Outcome|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11319022|NCT03285308|OG000|Outcome|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11319023|NCT03285308|EG000|Reported Event|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11319024|NCT03285308|EG001|Reported Event|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11319025|NCT03285373|BG000|Baseline|All Patients|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
11319026|NCT03285373|FG000|Participant Flow|Dabigatran|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.
11319027|NCT03285373|FG001|Participant Flow|Rivaroxaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.
11319028|NCT03285373|FG002|Participant Flow|Apixaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.
11319029|NCT03285373|FG003|Participant Flow|Edoxaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.
11319030|NCT03285373|OG000|Outcome|Dabigatran|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.
11319031|NCT03285373|OG001|Outcome|Rivaroxaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.
11319032|NCT03285373|OG002|Outcome|Apixaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.
11319033|NCT03285373|OG003|Outcome|Edoxaban|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.
11319034|NCT03285373|OG004|Outcome|All Patients|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
11319035|NCT03285373|OG000|Outcome|All Patients|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
11319036|NCT03285373|EG000|Reported Event|Dabigatran|Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.
11319037|NCT03285477|BG000|Baseline|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp
11319038|NCT03285477|BG001|Baseline|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
11319039|NCT03285477|BG002|Baseline|Total|Total of all reporting groups
11319040|NCT03285477|FG000|Participant Flow|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp
11319041|NCT03285477|FG001|Participant Flow|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
11319042|NCT03285477|OG000|Outcome|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp
11319043|NCT03285477|OG001|Outcome|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
11319044|NCT03285477|OG000|Outcome|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
11319045|NCT03285477|EG000|Reported Event|Placebo|The Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp
11319046|NCT03285477|EG001|Reported Event|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp
11319047|NCT03285490|BG000|Baseline|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319048|NCT03285490|BG001|Baseline|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319049|NCT03285490|BG002|Baseline|Total|Total of all reporting groups
11319050|NCT03285490|FG000|Participant Flow|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 centimeter square (cm^2) on face or scalp.
11319051|NCT03285490|FG001|Participant Flow|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319052|NCT03285490|OG000|Outcome|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319053|NCT03285490|OG001|Outcome|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319054|NCT03285490|OG000|Outcome|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319055|NCT03285490|EG000|Reported Event|Placebo|Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319056|NCT03285490|EG001|Reported Event|KX2-391 Ointment 1%|KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
11319057|NCT03285529|BG000|Baseline|STRATAFIX GROUP|"STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319058|NCT03285529|BG001|Baseline|CONTROL GROUP|"The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.~VICRYL: Vicryl #1"
11319059|NCT03285529|BG002|Baseline|Total|Total of all reporting groups
11319060|NCT03285529|FG000|Participant Flow|STRATAFIX GROUP|"STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319061|NCT03285529|FG001|Participant Flow|CONTROL GROUP|"The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.~VICRYL: Vicryl #1"
11319062|NCT03285529|OG000|Outcome|STRATAFIX GROUP|"STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319063|NCT03285529|OG001|Outcome|CONTROL GROUP|"The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.~VICRYL: Vicryl #1"
11319064|NCT03285529|EG000|Reported Event|STRATAFIX GROUP|"STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319065|NCT03285529|EG001|Reported Event|CONTROL GROUP|"The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.~VICRYL: Vicryl #1"
11319066|NCT03285542|BG000|Baseline|DERMABOND GROUP|"For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.~DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)"
11319067|NCT03285542|BG001|Baseline|CONTROL GROUP|"For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples~Staples: staples for skin closure"
11319068|NCT03285542|BG002|Baseline|Total|Total of all reporting groups
11319069|NCT03285542|FG000|Participant Flow|DERMABOND GROUP|"For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.~DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)"
11319070|NCT03285542|FG001|Participant Flow|CONTROL GROUP|"For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples~Staples: staples for skin closure"
11319071|NCT03285542|OG000|Outcome|DERMABOND GROUP|"For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.~DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)"
11319072|NCT03285542|OG001|Outcome|CONTROL GROUP|"For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples~Staples: staples for skin closure"
11319073|NCT03285542|EG000|Reported Event|DERMABOND GROUP|"For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.~DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)"
11319074|NCT03285542|EG001|Reported Event|CONTROL GROUP|"For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples~Staples: staples for skin closure"
11319075|NCT03285555|BG000|Baseline|STRATAFIX GROUP|"For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319076|NCT03285555|BG001|Baseline|CONTROL GROUP|"For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~VICRYL: Vicryl #1"
11319077|NCT03285555|BG002|Baseline|Total|Total of all reporting groups
11319078|NCT03285555|FG000|Participant Flow|STRATAFIX GROUP|"For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319079|NCT03285555|FG001|Participant Flow|CONTROL GROUP|"For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~VICRYL: Vicryl #1"
11319080|NCT03285555|OG000|Outcome|STRATAFIX GROUP|"For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319081|NCT03285555|OG001|Outcome|CONTROL GROUP|"For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~VICRYL: Vicryl #1"
11319082|NCT03285555|EG000|Reported Event|STRATAFIX GROUP|"For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture"
11319083|NCT03285555|EG001|Reported Event|CONTROL GROUP|"For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue~VICRYL: Vicryl #1"
11319084|NCT03285594|BG000|Baseline|Placebo|Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319085|NCT03285594|BG001|Baseline|Sotagliflozin 200 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319086|NCT03285594|BG002|Baseline|Sotagliflozin 400 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319087|NCT03285594|BG003|Baseline|Total|Total of all reporting groups
11319088|NCT03285594|FG000|Participant Flow|Placebo|Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs [OADs]) continued throughout the study.
11319089|NCT03285594|FG001|Participant Flow|Sotagliflozin 200 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319090|NCT03285594|FG002|Participant Flow|Sotagliflozin 400 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319091|NCT03285594|OG000|Outcome|Placebo|Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319092|NCT03285594|OG001|Outcome|Sotagliflozin 200 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319093|NCT03285594|OG002|Outcome|Sotagliflozin 400 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319094|NCT03285594|OG000|Outcome|Placebo|Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs [OADs]) continued throughout the study.
11319095|NCT03285594|EG000|Reported Event|Placebo|Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319096|NCT03285594|EG001|Reported Event|Sotagliflozin 200 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11319097|NCT03285594|EG002|Reported Event|Sotagliflozin 400 mg|Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
11333356|NCT03512353|BG000|Baseline|Carfilzomib Plus Dexamethasone|"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.~Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12."
11333357|NCT03512353|FG000|Participant Flow|Carfilzomib Plus Dexamethasone|"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.~Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12."
11333358|NCT03512353|OG000|Outcome|Carfilzomib Plus Dexamethasone|"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.~Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12."
11333359|NCT03512353|OG000|Outcome|1 Prior Line of Therapy|Participants with 1 prior line of therapy for multiple myeloma.
11333360|NCT03512353|OG001|Outcome|2+ Prior Lines of Therapy|Participants with ≥ 2 prior lines of therapy for multiple myeloma.
11333361|NCT03512353|EG000|Reported Event|Carfilzomib Plus Dexamethasone|"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.~Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12."
11319098|NCT03285646|BG000|Baseline|Fasinumab-matching Placebo|Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319099|NCT03285646|BG001|Baseline|Fasinumab 3 mg SC Q4W|Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319100|NCT03285646|BG002|Baseline|Total|Total of all reporting groups
11319101|NCT03285646|FG000|Participant Flow|Fasinumab-matching Placebo|Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319102|NCT03285646|FG001|Participant Flow|Fasinumab 3 mg SC Q4W|Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319103|NCT03285646|OG000|Outcome|Fasinumab-matching Placebo|Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319104|NCT03285646|OG001|Outcome|Fasinumab 3 mg SC Q4W|Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319105|NCT03285646|OG000|Outcome|Fasinumab 3 mg SC Q4W|Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319106|NCT03285646|EG000|Reported Event|Fasinumab-matching Placebo|Participants received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319107|NCT03285646|EG001|Reported Event|Fasinumab 3 mg SC Q4W|Participants received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) from day 1 through week 12 of the 16 week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±1 day) up to 16 weeks.
11319108|NCT03285711|BG000|Baseline|Lanraplenib 30 mg|Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
11319109|NCT03285711|BG001|Baseline|Filgotinib 200 mg|Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
11319110|NCT03285711|BG002|Baseline|Total|Total of all reporting groups
11319111|NCT03285711|FG000|Participant Flow|Lanraplenib 30 mg|"Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.~After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase."
11319112|NCT03285711|FG001|Participant Flow|Filgotinib 200 mg|"Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.~After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase."
11319113|NCT03285711|FG002|Participant Flow|Lanraplenib 30 mg to Filgotinib 200 mg|"At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.~At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase."
11319114|NCT03285711|FG003|Participant Flow|Filgotinib 200 mg to Lanraplenib 30 mg|"At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.~At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase."
11319115|NCT03285711|OG000|Outcome|Lanraplenib 30 mg|Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
11319116|NCT03285711|OG001|Outcome|Filgotinib 200 mg|Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
10827775|NCT00111813|OG001|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
11319117|NCT03285711|EG000|Reported Event|Up to Week 16: Lanraplenib 30 mg|Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
11319118|NCT03285711|EG001|Reported Event|Up to Week 16: Filgotinib 200 mg|Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
11319119|NCT03285711|EG002|Reported Event|After Week 16: Lanraplenib 30 mg|"At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily) for additional 16 weeks.~After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase."
11319120|NCT03285711|EG003|Reported Event|After Week 16: Filgotinib 200 mg|"At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily) for additional 16 weeks.~After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase."
11319121|NCT03285711|EG004|Reported Event|After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg|"At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.~At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase."
11319122|NCT03285711|EG005|Reported Event|After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg|"At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.~At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase."
11319123|NCT03285724|BG000|Baseline|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
11319124|NCT03285724|FG000|Participant Flow|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
11319125|NCT03285724|OG000|Outcome|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
11319126|NCT03285724|EG000|Reported Event|Harpoon Medical Device|Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.
11319127|NCT03285958|BG000|Baseline|STEPS Intervention Group|"Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.~STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer."
11319128|NCT03285958|BG001|Baseline|STEPS Control Group|Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
11319129|NCT03285958|BG002|Baseline|Total|Total of all reporting groups
11319130|NCT03285958|FG000|Participant Flow|STEPS Intervention Group|"Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.~STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer."
11319131|NCT03285958|FG001|Participant Flow|STEPS Control Group|Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
11319132|NCT03285958|OG000|Outcome|STEPS Intervention Group|"Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.~STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer."
11319133|NCT03285958|OG001|Outcome|STEPS Control Group|Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
11319134|NCT03285958|OG000|Outcome|STEPS Intervention Group|This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
11319135|NCT03285958|EG000|Reported Event|STEPS Intervention Group|"Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.~STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer."
11319136|NCT03285958|EG001|Reported Event|STEPS Control Group|Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
11319137|NCT03285984|BG000|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
11319138|NCT03285984|FG000|Participant Flow|Overall Study|This was a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design study. Each Participant received Test product 1 (Toothpaste containing 67 percent [%] sodium bicarbonate with 6 herbs plus 923 parts per million [ppm] sodium fluoride, Test product 2 (Toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), Test product 3 (Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% weight by weight [w/w] silica plus 923ppm Sodium), and Test product 4 (Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride).
11319139|NCT03285984|OG000|Outcome|Test Product 1|Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923 ppm sodium fluoride), under supervision of study staff for one timed minute.
11319140|NCT03285984|OG001|Outcome|Test Product 4|Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319141|NCT03285984|OG000|Outcome|Test Product 1|Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319142|NCT03285984|OG001|Outcome|Test Product 2|Participants brushed once (1.5g ± 0.05g of toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319143|NCT03285984|OG002|Outcome|Test Product 3|Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.
11319144|NCT03285984|OG003|Outcome|Test Product 4|Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319145|NCT03285984|EG000|Reported Event|Test Product 1|Participants brushed once (1.5g ± 0.05g of Toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319146|NCT03285984|EG001|Reported Event|Test Product 2|Participants brushed once (1.5g ± 0.05g of toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319147|NCT03285984|EG002|Reported Event|Test Product 3|Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.
11319148|NCT03285984|EG003|Reported Event|Test Product 4|Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
11319149|NCT03286218|BG000|Baseline|Overall Participants|All participants received one dose of alprazolam and placebo in the qualification phase and participants received at least one dose lasmiditan, alprazolam and/or placebo in the treatment phase.
11319150|NCT03286218|FG000|Participant Flow|Qualification Phase - Alprazolam Then Placebo Sequence 1|Sequence 1 - One tablet of 1 milligram (mg) alprazolam was administered orally in period 1 then placebo period 2.
11319151|NCT03286218|FG001|Participant Flow|Qualification Phase - Placebo Then Alprazolam (Alp) Sequence 2|Sequence 2 - Placebo was administered orally period 1 then one tablet of 2 mg alprazolam period 2.
11319152|NCT03286218|FG002|Participant Flow|Sequence 1|"Sequence 1, Periods 1 - 5: (Placebo, 100 mg Las, 2 mg Alp, 200 mg Las, then 400 mg Las)~All participants received:~Period 1: Placebo Period 2: 100 mg Las Period 3: 200 mg Las Period 4: 400 mg Las Period 5: 2 mg Alp~Orally with a 3 day washout between doses."
11319153|NCT03286218|FG003|Participant Flow|Sequence 2|"Sequence 2 , Periods 1 - 5: (100 mg Las, 200 mg Las, Placebo, 400 mg Las, then 2 mg Alp)~All participants received:~Period 1: 100 mg Las Period 2: 200 mg Las Period 3: Placebo Period 4: 400 mg Las Period 5: 2 mg Alp~Orally with a 3 day washout between doses."
11319154|NCT03286218|FG004|Participant Flow|Sequence 3|"Sequence 3, Periods 1 - 5: (200 mg Las, 400 mg Las, 100 mg Las, 2 mg Alp, then Placebo)~All participants received:~Period 1: 200 mg Las Period 2: 400 mg Las Period 3: 100 mg Las Period 4: 2 mg Las Period 5: Placebo~Orally with a 3 day washout between doses."
11319155|NCT03286218|FG005|Participant Flow|Sequence 4|"Sequence 4, Periods 1 - 5: (400 mg Las, 2 mg Alp, 200 mg Las, Placebo, then 100 mg Las)~All participants received:~Period 1: 400 mg Las Period 2: 2 mg Alp Period 3: 200 mg Las Period 4: Placebo Period 5: 100 mg Las~Orally with a 3 day washout between doses."
11319156|NCT03286218|FG006|Participant Flow|Sequence 5|"Sequence 5, Periods 1 - 5: (2 mg Alp, Placebo, 400 mg Las, then 200 mg Las)~All participants received:~Period 1: 2 mg Alp Period 2: Placebo Period 3: 400 mg Las Period 4: 200 mg Las Period 5: 100 mg Las~Orally with a 3 day washout between doses."
11319157|NCT03286218|FG007|Participant Flow|Sequence 6|"Sequence 6, Periods 1 - 5 (400 mg Las, 200 mg Las, 2 mg Alp, 100 mg Las, then Placebo)~All participants received:~Period 1: 400 mg Las Period 2: 200 mg Las Period 3: 2 mg Alp Period 4: 100 mg Las Period 5: Placebo~Orally with a 3 day washout between doses."
11319158|NCT03286218|FG008|Participant Flow|Sequence 7|"Sequence 7, Periods 1-5: (2 mg Alp, 400 mg Las, Placebo, 200 mg Las, then 100 mg Las)~All participants received:~Period 1: 2 mg Alp Period 2: 400 mg Las Period 3: Placebo Period 4: 200 mg Las Period 5: 100 mg Las~Orally with a 3 day washout between doses."
11319159|NCT03286218|FG009|Participant Flow|Sequence 8|"Sequence 8, Periods 1 - 5: Placebo, 2 mg Lap, 100 mg Las, 400 mg Las, then 200 mg Las)~All participants received:~Period 1: Placebo Period 2: 2 mg Las Period 3: 100 mg Las Period 4: 400 mg Las Period 5: 200 mg Las~Orally with a 3 day washout between doses."
11319160|NCT03286218|FG010|Participant Flow|Sequence 9|"Sequence 9, Periods 1 - 5: (100 mg Las, Placebo, 200 mg Las, 2 mg Alp, 400 mg Las)~All participants received:~Period 1: 100 mg Las Period 2: Placebo Period 3: 200 mg Las Period 4: 2 mg Alp Period 5: 400 mg Las~Orally with a 3 day washout between doses."
11319161|NCT03286218|FG011|Participant Flow|Sequence 10|"Sequence 10, Periods 1 - 5: (200 mg Las, 100 mg Las, 400 mg Las, Placebo, then 2 mg Alp)~All participants received:~Period 1: 200 mg Las Period 2: 100 mg Las Period 3: 400 mg Las Period 4: Placebo Period 5: 2 mg Alp~Orally with a 3 day washout between doses."
11319162|NCT03286218|OG000|Outcome|Placebo|Placebo was administered orally in one of five treatment periods.
11319163|NCT03286218|OG001|Outcome|Alprazolam - 2 mg|2 mg of Alprazolam administered orally in one of five treatment periods
11319164|NCT03286218|OG002|Outcome|Lasmiditan - 100 mg|100 mg of lasmiditan administered orally in one of five treatment periods
11319165|NCT03286218|OG003|Outcome|Lasmiditan - 200 mg|200 mg of lasmiditan administered orally in one of five treatment periods
11319166|NCT03286218|OG004|Outcome|Lasmiditan - 400 mg|400 mg of lasmiditan administered orally in one of five treatment periods
11319167|NCT03286218|OG000|Outcome|Lasmiditan - 100 mg|100 mg of lasmiditan administered orally in one of five treatment periods
11319168|NCT03286218|OG001|Outcome|Lasmiditan - 200 mg|200 of lasmiditan administered orally in one of five treatment periods
11319169|NCT03286218|OG002|Outcome|Lasmiditan - 400 mg|400 mg of lasmiditan administered orally in one of five treatment periods
11319170|NCT03286218|OG000|Outcome|Lasmiditan - 100 mg|100 mg lasmiditan administered orally in one of five treatment periods
11319171|NCT03286218|OG001|Outcome|Lasmiditan - 200 mg|200 mg of lasmiditan administered orally in one of five treatment periods
11319172|NCT03286218|OG002|Outcome|Lasmiditan - 400 mg Dose|400 of lasmiditan administered orally in one of five treatment periods
11319173|NCT03286218|OG000|Outcome|Placebo - Qualification Phase|Placebo was administered orally in one of 2 treatment periods.
11319174|NCT03286218|OG001|Outcome|1 mg Alprazolam - Qualification Phase|1 mg of Alprazolam was administered orally in one of 2 treatment periods.
11319175|NCT03286218|OG002|Outcome|Placebo|Placebo was administered orally in one of five treatment periods.
11319176|NCT03286218|OG003|Outcome|2 mg Alprazolam|2 mg of Alprazolam was administered orally in one of five treatment periods.
11319177|NCT03286218|OG004|Outcome|Lasmiditan - 100 mg|100 mg of lasmiditan administered orally in one of five treatment periods
11319178|NCT03286218|OG005|Outcome|Lasmiditan - 200 mg|200 mg of lasmiditan administered orally in one of five treatment periods
11319179|NCT03286218|OG006|Outcome|Lasmiditan - 400 mg|400 mg of lasmiditan administered orally in one of five treatment periods
11319180|NCT03286218|EG000|Reported Event|Qualification Phase - Placebo|Placebo was administered orally.
11319181|NCT03286218|EG001|Reported Event|Qualification Phase - Alprazolam|1 mg of alprazolam was administered orally.
11319182|NCT03286218|EG002|Reported Event|Treatment Phase - Placebo|Placebo was administered orally in one of five treatment periods.
11319183|NCT03286218|EG003|Reported Event|Treatment Phase - 2 mg Alprazolam|2 mg alprazolam was administered orally in one of five treatment periods.
11319184|NCT03286218|EG004|Reported Event|Treatment Phase - 100 mg Lasmiditan|100 mg of Lasmiditan was administered orally in one of five treatment periods.
11319185|NCT03286218|EG005|Reported Event|Treatment Phase - 200 mg Lasmiditan|200 mg of Lasmiditan was administered orally in one of five treatment periods.
11319186|NCT03286218|EG006|Reported Event|Treatment Phase - 400 mg Lasmiditan|400 mg of Lasmiditan was administered orally in one of five treatment periods.
11319187|NCT03286283|BG000|Baseline|J-Plasma|"Each study subject received one procedure with J-Plasma at enrollment.~J-Plasma: Dermal resurfacing procedure with J-Plasma."
11319188|NCT03286283|FG000|Participant Flow|J-Plasma|"Each study subject will receive one procedure with J-Plasma at enrollment.~J-Plasma: Dermal resurfacing procedure with J-Plasma."
11319189|NCT03286283|OG000|Outcome|J-Plasma|"Each study subject received one procedure with J-Plasma at enrollment.~J-Plasma: Dermal resurfacing procedure with J-Plasma."
11319190|NCT03286283|EG000|Reported Event|J-Plasma|"Each study subject received one procedure with J-Plasma at enrollment.~J-Plasma: Dermal resurfacing procedure with J-Plasma."
11319191|NCT03286400|BG000|Baseline|CTAG Device With ACTIVE CONTROL|"All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.~CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice."
11319192|NCT03286400|FG000|Participant Flow|CTAG Device With ACTIVE CONTROL|"All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.~CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice."
11319193|NCT03286400|OG000|Outcome|CTAG Device With ACTIVE CONTROL|"All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.~CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice."
11319194|NCT03286400|EG000|Reported Event|CTAG Device With ACTIVE CONTROL|"All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.~CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice."
11319195|NCT03286465|BG000|Baseline|Pediatric Phlebotomy Tubes|Use of pediatric size tubes for diagnostic blood collection.
11319196|NCT03286465|BG001|Baseline|Adult Phlebotomy Tubes|Use of adult size tubes for diagnostic blood collection.
11319197|NCT03286465|BG002|Baseline|Total|Total of all reporting groups
11319198|NCT03286465|FG000|Participant Flow|Pediatric Phlebotomy Tubes|Use of pediatric size tubes for diagnostic blood collection.
11319199|NCT03286465|FG001|Participant Flow|Adult Phlebotomy Tubes|Use of adult size tubes for diagnostic blood collection.
11319200|NCT03286465|OG000|Outcome|Pediatric Phlebotomy Tubes|Use of pediatric size tubes for diagnostic blood collection.
11319201|NCT03286465|OG001|Outcome|Adult Phlebotomy Tubes|Use of adult size tubes for diagnostic blood collection.
11319202|NCT03286465|EG000|Reported Event|Pediatric Phlebotomy Tubes|Use of pediatric size tubes for diagnostic blood collection.
11319203|NCT03286465|EG001|Reported Event|Adult Phlebotomy Tubes|Use of adult size tubes for diagnostic blood collection.
11319204|NCT03286543|BG000|Baseline|Treatment Group|Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.
11319205|NCT03286543|BG001|Baseline|Control Group|Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.
11319206|NCT03286543|BG002|Baseline|Total|Total of all reporting groups
11319207|NCT03286543|FG000|Participant Flow|Consented Subjects|Subjects who signed an informed consent form.
11319208|NCT03286543|FG001|Participant Flow|Treatment Group|Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.
11319209|NCT03286543|FG002|Participant Flow|Control Group|Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.
11319210|NCT03286543|OG000|Outcome|Treatment Group|Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.
11319211|NCT03286543|OG001|Outcome|Control Group|Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.
11319212|NCT03286543|EG000|Reported Event|Treatment Group|Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.
11319213|NCT03286543|EG001|Reported Event|Control Group|Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.
11319214|NCT03286751|BG000|Baseline|Overall|All participants who received at least on dose of study drug.
11319215|NCT03286751|FG000|Participant Flow|Sequence 1: ABFCED|"Participants received a single SC dose in each treatment period.~A = 7 U LY900014~B = 15 U LY900014~F = 30 U Humalog~C = 30 U LY900014~E = 15 U Humalog~D = 7 U Humalog"
11319216|NCT03286751|FG001|Participant Flow|Sequence 2: BCADFE|"Participants received a single SC dose in each treatment period.~B = 15 U LY900014~C = 30 U LY900014~A = 7 U LY900014~D = 7 U Humalog~F = 30 U Humalog~E = 15 U Humalog"
11319217|NCT03286751|FG002|Participant Flow|Sequence 3: CDBEAF|"Participants received a single SC dose in each treatment period.~C = 30 U LY900014~D = 7 U Humalog~B = 15 U LY900014~E = 15 U Humalog~A = 7 U LY900014~F = 30 U Humalog"
11319218|NCT03286751|FG003|Participant Flow|Sequence 4: DECFBA|"Participants received a single SC dose in each treatment period.~D = 7 U Humalog~E = 15 U Humalog~C = 30 U LY900014~F = 30 U Humalog~B = 15 U LY900014~A = 7 U LY900014"
11319219|NCT03286751|FG004|Participant Flow|Sequence 5: EFDACB|"Participants received a single SC dose in each treatment period.~E = 15 U Humalog~F = 30 U Humalog~D = 7 U Humalog~A = 7 U LY900014~C = 30 U LY900014~B = 15 U LY900014"
11319220|NCT03286751|FG005|Participant Flow|Sequence 6: FAEBDC|"Participants received a single SC dose in each treatment period.~F = 30 U Humalog~A = 7 U LY900014~E = 15 U Humalog~B = 15 U LY900014~D = 7 U Humalog~C = 30 U LY900014"
11319221|NCT03286751|OG000|Outcome|7 U Humalog|Single SC dose 7 U Humalog.
11319222|NCT03286751|OG001|Outcome|7 U LY900014|Single SC dose 7 U LY900014.
11319223|NCT03286751|OG002|Outcome|15 U Humalog|Single SC dose 15 U Humalog.
11319224|NCT03286751|OG003|Outcome|15 U LY900014|Single SC dose 15 U LY900014.
11319225|NCT03286751|OG004|Outcome|30 U Humalog|Single SC dose 30 U Humalog.
11319226|NCT03286751|OG005|Outcome|30 U LY900014|Single SC dose 30 U LY900014.
11319227|NCT03286751|EG000|Reported Event|7 U LY900014|Single SC dose 7 U LY900014.
11319228|NCT03286751|EG001|Reported Event|15 U LY900014|Single SC dose 15 U LY900014.
11319229|NCT03286751|EG002|Reported Event|30 U LY900014|Single SC dose 30 U LY900014.
11319230|NCT03286751|EG003|Reported Event|7 U Humalog|Single SC dose 7 U Humalog.
11319231|NCT03286751|EG004|Reported Event|15 U Humalog|Single SC dose 15 U Humalog.
11319232|NCT03286751|EG005|Reported Event|30 U Humalog|Single SC dose 15 U Humalog.
11319233|NCT03286829|BG000|Baseline|"Tesomet High Dose in Fasted Condition"|"Tesomet FDC tablet (20 mg immediate release [IR] metoprolol, 1 mg tesofensine, 80 mg extended release [ER] metoprolol) in fasted condition (High dose)"
11319234|NCT03286829|BG001|Baseline|"Tesomet Low Dose in Fasted Condition"|"Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. (Low dose)"
11319235|NCT03286829|BG002|Baseline|Comparator|1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
11319236|NCT03286829|BG003|Baseline|"Tesomet High Dose in Fed Condition"|"Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition (High dose)"
11319237|NCT03286829|BG004|Baseline|Total|Total of all reporting groups
11319238|NCT03286829|FG000|Participant Flow|"Tesomet High Dose in Fasted Condition"|"A Tesomet FDC tablet (20 mg immediate release [IR] metoprolol, 1 mg tesofensine, 80 mg extended release [ER] metoprolol) in fasted condition (High dose)"
11319239|NCT03286829|FG001|Participant Flow|"Tesomet Low Dose in Fasted Condition"|"A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. (Low dose)"
11319240|NCT03286829|FG002|Participant Flow|Comparator|1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
11319241|NCT03286829|FG003|Participant Flow|"Tesomet High Dose in Fed Condition"|"A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition (High dose)"
11319242|NCT03286829|OG000|Outcome|"Tesomet High Dose in Fasted Condition"|"Tesomet FDC tablet (20 mg immediate release [IR] metoprolol, 1 mg tesofensine, 80 mg extended release [ER] metoprolol) in fasted condition (High dose)"
11319243|NCT03286829|OG001|Outcome|"Tesomet Low Dose in Fasted Condition"|"Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. (Low dose)"
11319244|NCT03286829|OG002|Outcome|Comparator|1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
11319245|NCT03286829|OG003|Outcome|"Tesomet High Dose in Fed Condition"|"A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition (High dose)"
11319246|NCT03286829|OG001|Outcome|"Tesomet Low Dose in Fasted Condition"|"A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. (Low dose)"
11319247|NCT03286829|OG000|Outcome|"Tesomet High Dose in Fasted Condition"|"A Tesomet FDC tablet (20 mg immediate release [IR] metoprolol, 1 mg tesofensine, 80 mg extended release [ER] metoprolol) in fasted condition (High dose)"
11319248|NCT03286829|EG000|Reported Event|"Tesomet High Dose in Fasted Condition"|"A Tesomet FDC tablet (20 mg immediate release [IR] metoprolol, 1 mg tesofensine, 80 mg extended release [ER] metoprolol) in fasted condition (High dose)"
11319249|NCT03286829|EG001|Reported Event|"Tesomet Low Dose in Fasted Condition"|"A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. (Low dose)"
11319250|NCT03286829|EG002|Reported Event|Comparator|1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
11319251|NCT03286829|EG003|Reported Event|"Tesomet High Dose in Fed Condition"|"A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition (High dose)"
11319252|NCT03287219|BG000|Baseline|Methylene Blue MMX 150mg|Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 150 mg
11319253|NCT03287219|BG001|Baseline|Methylene Blue MMX 200mg|Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 200 mg
11319254|NCT03287219|BG002|Baseline|Total|Total of all reporting groups
11319255|NCT03287219|FG000|Participant Flow|150 mg Methylene Blue-MMX Tablets|"take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg~Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation."
11319256|NCT03287219|FG001|Participant Flow|200 mg Methylene Blue-MMX Tablets|"take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg~Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation."
11319257|NCT03287219|OG000|Outcome|A (Dose:150mg)|"Number of tablets taken in relation to the intake of the bowel cleansing preparation:~At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0"
11319258|NCT03287219|OG001|Outcome|B (Dose:150mg)|"Number of tablets taken in relation to the intake of the bowel cleansing preparation:~At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0"
11319259|NCT03287219|OG002|Outcome|C (Dose:150mg)|"Number of tablets taken in relation to the intake of the bowel cleansing preparation:~At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6"
11319260|NCT03287219|OG003|Outcome|D (Dose:200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
11319261|NCT03287219|OG004|Outcome|E (Dose:200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
11319262|NCT03287219|OG005|Outcome|F (Dose:200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
11319263|NCT03287219|OG006|Outcome|G (Dose 200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
11319264|NCT03287219|OG007|Outcome|H (Dose:200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
11319265|NCT03287219|OG008|Outcome|I (Dose:200mg)|Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
11319266|NCT03287219|OG009|Outcome|J (Dose:200mg)|"Number of tablets taken in relation to the intake of the bowel cleansing preparation:~At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3"
11319267|NCT03287219|OG000|Outcome|Pre Colonoscopy - 150mg Dose|Vital Signs - safety Population -- 150mg dose
11319268|NCT03287219|OG001|Outcome|Pre Colonoscopy- 200mg Dose|Vital Signs - safety Population- 200mg dose
11319269|NCT03287219|OG002|Outcome|During Colonoscopy- 150mg Dose|Vital Signs - safety Population- 150mg dose
11319270|NCT03287219|OG003|Outcome|During Colonoscopy- 200mg Dose|Vital Signs - safety Population- 200mg dose
11319271|NCT03287219|OG004|Outcome|Post Colonoscopy- 150mg Dose|Vital Signs - safety Population- 150mg dose
11319272|NCT03287219|OG005|Outcome|Post Colonoscopy- 200mg Dose|Vital Signs - safety Population- 200mg dose
11319273|NCT03287219|OG000|Outcome|Pre Colonoscopy - 150mg Dose|Vital Signs - safety Population - 150mg dose
11319274|NCT03287219|OG001|Outcome|Pre Colonoscopy- 200mg Dose|Vital Signs - safety Population - 200mg dose
11319275|NCT03287219|OG002|Outcome|During Colonoscopy - 150mg Dose|Vital Signs - safety Population - 150mg dose
11319276|NCT03287219|OG003|Outcome|During Colonoscopy- 200mg Dose|Vital Signs - safety Population - 200mg dose
11319277|NCT03287219|OG004|Outcome|Post Colonoscopy- 150mg Dose|Vital Signs - safety Population - 150mg dose
11319278|NCT03287219|OG005|Outcome|Post Colonoscopy- 200mg Dose|Vital Signs - safety Population - 200mg dose
11319279|NCT03287219|OG000|Outcome|Pre Colonoscopy - 150mg Dose|Vital Signs - safety Population
11319280|NCT03287219|OG001|Outcome|Pre Colonoscopy- 200mg Dose|
11319281|NCT03287219|OG002|Outcome|During Colonoscopy- 150mg Dose|Vital Signs - safety Population
11319282|NCT03287219|OG003|Outcome|During Colonoscopy- 200mg Dose|
11319283|NCT03287219|OG004|Outcome|Post Colonoscopy- 150mg Dose|Vital Signs - safety Population
11319284|NCT03287219|OG005|Outcome|Post Colonoscopy- 200mg Dose|
11319285|NCT03287219|OG000|Outcome|Visit 1-Screening 150mL|Safety Population 150mL Dose
11319286|NCT03287219|OG001|Outcome|Visit 1-Screening 200mL|Safety Population 200mL Dose
11319287|NCT03287219|OG002|Outcome|Visit 2-Final 150mL|Safety Population 150mL Dose
11319288|NCT03287219|OG003|Outcome|Visit 2-Final 200mL|Safety Population 200mL Dose
11319289|NCT03287219|OG000|Outcome|150 mg Methylene Blue-MMX Tablets|"take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg~Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation."
11319290|NCT03287219|OG001|Outcome|200 mg Methylene Blue-MMX Tablets|"take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg~Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation."
11319291|NCT03287219|OG002|Outcome|Overall|Overall Colon cleansing score
11319292|NCT03287219|EG000|Reported Event|AEs Methylene Blue-MMX Tablets Equivalent to 150 mg|Patients under going Colonoscpy taking Methylene Blue MMX Dose 150mL
11319293|NCT03287219|EG001|Reported Event|AEs Methylene Blue-MMX Tablets Equivalent to 200 mg|Patients under going Colonoscpy taking Methylene Blue MMX dose 200 mg
11319294|NCT03287310|BG000|Baseline|Placebo|Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
11319295|NCT03287310|BG001|Baseline|GSK3511294 2mg|Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
11319296|NCT03287310|BG002|Baseline|GSK3511294 10mg|Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
11319297|NCT03287310|BG003|Baseline|GSK3511294 30mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319298|NCT03287310|BG004|Baseline|GSK3511294 100mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319299|NCT03287310|BG005|Baseline|GSK3511294 300mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319300|NCT03287310|BG006|Baseline|Total|Total of all reporting groups
11319301|NCT03287310|FG000|Participant Flow|Placebo|Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
11319302|NCT03287310|FG001|Participant Flow|GSK3511294 2 mg|Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
11319303|NCT03287310|FG002|Participant Flow|GSK3511294 10 mg|Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
11319304|NCT03287310|FG003|Participant Flow|GSK3511294 30 mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319305|NCT03287310|FG004|Participant Flow|GSK3511294 100 mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319306|NCT03287310|FG005|Participant Flow|GSK3511294 300 mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319307|NCT03287310|OG000|Outcome|Placebo|Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
11319308|NCT03287310|OG001|Outcome|GSK3511294 2mg|Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
11319309|NCT03287310|OG002|Outcome|GSK3511294 10mg|Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
11319310|NCT03287310|OG003|Outcome|GSK3511294 30mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319311|NCT03287310|OG004|Outcome|GSK3511294 100mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319312|NCT03287310|OG005|Outcome|GSK3511294 300mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319313|NCT03287310|OG000|Outcome|GSK3511294 2mg|Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
11319314|NCT03287310|OG001|Outcome|GSK3511294 10mg|Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
11319315|NCT03287310|OG000|Outcome|GSK3511294 30mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319316|NCT03287310|OG001|Outcome|GSK3511294 100mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319317|NCT03287310|OG000|Outcome|GSK3511294 300mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319318|NCT03287310|OG002|Outcome|GSK3511294 30mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319319|NCT03287310|OG003|Outcome|GSK3511294 100mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319320|NCT03287310|OG004|Outcome|GSK3511294 300mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319321|NCT03287310|EG000|Reported Event|Placebo|Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
11319322|NCT03287310|EG001|Reported Event|GSK3511294 2mg|Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
11319323|NCT03287310|EG002|Reported Event|GSK3511294 10mg|Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
11319324|NCT03287310|EG003|Reported Event|GSK3511294 30mg|Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
11319325|NCT03287310|EG004|Reported Event|GSK3511294 100mg|Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
11319326|NCT03287310|EG005|Reported Event|GSK3511294 300mg|Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
11319327|NCT03287622|BG000|Baseline|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback.~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
11319328|NCT03287622|BG001|Baseline|Standard of Care|This group will receive routine, standard of care information.
11319329|NCT03287622|BG002|Baseline|Total|Total of all reporting groups
11319330|NCT03287622|FG000|Participant Flow|Education Intervention|"This group will receive the scenario-tailored STOMP educational feedback.~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
11319331|NCT03287622|FG001|Participant Flow|Standard of Care|This group will receive routine, standard of care information
11319332|NCT03287622|OG000|Outcome|Education Intervention|"This group received the scenario-tailored STOMP educational feedback.~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
11319333|NCT03287622|OG001|Outcome|Standard of Care Education|This group received routine, standard of care information.
11319334|NCT03287622|OG001|Outcome|Standard of Care|This group received routine, standard of care information
11319335|NCT03287622|OG000|Outcome|Nudge + Educational Intervention|"This group received BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention~Nudge: Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids"
11319336|NCT03287622|OG001|Outcome|Nudge + Standard of Care|"This group received routine, standard of care information AND the behavioral Nudge intervention~Nudge: Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids"
11319337|NCT03287622|OG002|Outcome|Educational Intervention Only (No Nudge)|"This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
11319338|NCT03287622|OG003|Outcome|Standard of Care Only (No Nudge)|This group received only standard of care information and NO behavioral nudge intervention.
11319339|NCT03287622|OG001|Outcome|Standard of Care|This group will receive routine, standard of care information
11319340|NCT03287622|OG001|Outcome|Standard of Care Only|This group received routine, standard of care information
11319341|NCT03287622|EG000|Reported Event|Education Intervention|"This group received the scenario-tailored STOMP educational feedback.~Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises."
11319342|NCT03287622|EG001|Reported Event|Standard of Care|This group received routine, standard of care information
11319343|NCT03287635|BG000|Baseline|Acthar Gel 80 U/ml|"Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.~Corticotropin 80Unit/Ml Repository Injection: H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus."
11319344|NCT03287635|FG000|Participant Flow|Acthar Gel 80 U/ml|"Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.~Corticotropin 80Unit/Ml Repository Injection: H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus."
11333362|NCT03512457|BG000|Baseline|Intensive Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.~Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure."
11333363|NCT03512457|BG001|Baseline|Minimal Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology.~Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure."
11333364|NCT03512457|BG002|Baseline|Total|Total of all reporting groups
11319345|NCT03287635|OG000|Outcome|Acthar Gel 80 U/ml|"Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.~Corticotropin 80Unit/Ml Repository Injection: H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus."
11319346|NCT03287635|EG000|Reported Event|Acthar Gel 80 U/ml|"Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.~Corticotropin 80Unit/Ml Repository Injection: H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus."
11319347|NCT03287674|BG000|Baseline|TIL Treated Patients|Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
11319348|NCT03287674|FG000|Participant Flow|TIL Treated Patients|Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
11319349|NCT03287674|OG000|Outcome|TIL Treated Patients|Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
11319350|NCT03287674|OG000|Outcome|Patient Group|Patients treated with TILs
11319351|NCT03287674|EG000|Reported Event|TIL Treated Patients|Ipilimumab Cyclophospamide Fludarabine Nivolumab TILs IL-2
11319352|NCT03287791|BG000|Baseline|Generic Azelaic Acid Foam|A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319353|NCT03287791|BG001|Baseline|Finacea (Azelaic Acid) Foam|A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319354|NCT03287791|BG002|Baseline|Vehicle Foam|A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319355|NCT03287791|BG003|Baseline|Total|Total of all reporting groups
11319356|NCT03287791|FG000|Participant Flow|Generic Azelaic Acid Foam|A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks (wks). Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319357|NCT03287791|FG001|Participant Flow|Finacea (Azelaic Acid) Foam|A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319358|NCT03287791|FG002|Participant Flow|Vehicle Foam|A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319359|NCT03287791|OG000|Outcome|Generic Azelaic Acid Foam|A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319360|NCT03287791|OG001|Outcome|Finacea (Azelaic Acid) Foam|A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319361|NCT03287791|OG002|Outcome|Vehicle Foam|A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319362|NCT03287791|EG000|Reported Event|Generic Azelaic Acid Foam|A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319363|NCT03287791|EG001|Reported Event|Finacea (Azelaic Acid) Foam|A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319364|NCT03287791|EG002|Reported Event|Vehicle Foam|A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
11319365|NCT03287804|BG000|Baseline|AUTO2|Relapsed or refractory myeloma patients
11319366|NCT03287804|FG000|Participant Flow|AUTO2|Relapsed or refractory myeloma patients.
11319367|NCT03287804|OG000|Outcome|AUTO2|Relapsed or refractory myeloma patients
11319368|NCT03287804|OG000|Outcome|AUTO2|Relapsed or refractory myeloma patients.
11319369|NCT03287804|EG000|Reported Event|AUTO2|Relapsed or refractory myeloma patients
11319370|NCT03287869|BG000|Baseline|Prior Brexpiprazole|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group.
11319371|NCT03287869|BG001|Baseline|Prior Placebo|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group.
11319372|NCT03287869|BG002|Baseline|Total|Total of all reporting groups
11319373|NCT03287869|FG000|Participant Flow|Prior Brexpiprazole|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group.
11319374|NCT03287869|FG001|Participant Flow|Prior Placebo|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group.
10827776|NCT00111813|OG002|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11319375|NCT03287869|OG000|Outcome|Prior Brexpiprazole|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group.
11333365|NCT03512457|FG000|Participant Flow|Intensive Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.~Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure."
11319376|NCT03287869|OG001|Outcome|Prior Placebo|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group.
11319377|NCT03287869|EG000|Reported Event|Prior Brexpiprazole|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group.
11319378|NCT03287869|EG001|Reported Event|Prior Placebo|Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group.
11319379|NCT03288714|BG000|Baseline|Active sTMS|"Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.~Synchronized Transcranial Magnetic Stimulation (sTMS): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF)."
11319380|NCT03288714|BG001|Baseline|Sham Stimulation|"Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.~Sham Stimulation: Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain."
11319381|NCT03288714|BG002|Baseline|Total|Total of all reporting groups
11319382|NCT03288714|FG000|Participant Flow|Active sTMS|"Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.~Synchronized Transcranial Magnetic Stimulation (sTMS): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF)."
11319383|NCT03288714|FG001|Participant Flow|Sham Stimulation|"Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.~Sham Stimulation: Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain."
11319384|NCT03288714|OG000|Outcome|Active sTMS|"Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.~Synchronized Transcranial Magnetic Stimulation (sTMS): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF)."
11319385|NCT03288714|OG001|Outcome|Sham Stimulation|"Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.~Sham Stimulation: Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain."
11319386|NCT03288714|OG000|Outcome|Active sTMS (IAF > 9.8Hz)|"Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.~Synchronized Transcranial Magnetic Stimulation (sTMS): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF), subgroup of those participants were found to be greater than 9.8Hz"
11319387|NCT03288714|OG001|Outcome|Sham Stimulation (IAF>9.8Hz)|"Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.~Sham Stimulation: Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain. All patients analyzed and compared with other belonging to same subgroup of those with IAF greater than 9.8Hz."
11319388|NCT03288714|EG000|Reported Event|Active sTMS|"Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.~Synchronized Transcranial Magnetic Stimulation (sTMS): sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF)."
11319389|NCT03288714|EG001|Reported Event|Sham Stimulation|"Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.~Sham Stimulation: Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain."
11319390|NCT03288779|BG000|Baseline|Patients With a Diagnosis of Schizophrenia|We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study.
11333366|NCT03512457|FG001|Participant Flow|Minimal Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology.~Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure."
11333367|NCT03512457|OG000|Outcome|Intensive Intervention|Women who received an educational brochure and a 1-week reminder call or email to complete SSE
11333368|NCT03512457|OG001|Outcome|Educational Intervention|Women who only received a brochure.
11319391|NCT03288779|FG000|Participant Flow|Patients With a Diagnosis of Schizophrenia|"We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study.~Intervention administered - Theta Burst Stimulation (TBS) with Brief Assessment of Cognition in Schizophrenia (BACS) administered before and after TBS."
11319392|NCT03288779|OG000|Outcome|Theta Burst Stimulation Arm|"This is a pilot open label study.~Theta Burst Stimulation: Transcranial magnetic stimulation with theta burst stimulation"
11319393|NCT03288779|EG000|Reported Event|Patients With a Diagnosis of Schizophrenia|We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study.
11319394|NCT03288987|BG000|Baseline|Bevacizumab + FOLFIRI-3 (AryoGen Pharmed Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (AryoGen) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319395|NCT03288987|BG001|Baseline|Bevacizumab + FOLFIRI-3 (Roche Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (Avastin®) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319396|NCT03288987|BG002|Baseline|Total|Total of all reporting groups
11319397|NCT03288987|FG000|Participant Flow|Bevacizumab + FOLFIRI-3 (AryoGen Pharmed Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (AryoGen) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319398|NCT03288987|FG001|Participant Flow|Bevacizumab + FOLFIRI-3 (Roche Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (Avastin®) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319399|NCT03288987|OG000|Outcome|Bevacizumab + FOLFIRI-3 (AryoGen Pharmed Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (AryoGen) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319400|NCT03288987|OG001|Outcome|Bevacizumab + FOLFIRI-3 (Roche Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (Avastin®) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319401|NCT03288987|EG000|Reported Event|Bevacizumab + FOLFIRI-3 (AryoGen Pharmed Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (AryoGen) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319402|NCT03288987|EG001|Reported Event|Bevacizumab + FOLFIRI-3 (Roche Bevacizumab)|"Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (Avastin®) 5 mg/kg will be administered every 2 weeks.~Bevacizumab + FOLFIRI-3: Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent."
11319403|NCT03289052|BG000|Baseline|Group A|The first 2 eligible subjects for each Treating Investigator will receive treatment as Group A.
11319404|NCT03289052|BG001|Baseline|Restylane Volyme Treatment Group of Group B|Subjects assigned in this group will receive Restylane Volyme treatment at day 1.
11319405|NCT03289052|BG002|Baseline|Control Group of Group B|Subjects assigned in this group will receive no treatment at day 1, but at 6m visit.
11319406|NCT03289052|BG003|Baseline|Total|Total of all reporting groups
11319407|NCT03289052|FG000|Participant Flow|Group A|The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
11319408|NCT03289052|FG001|Participant Flow|Group B-Restylane Volyme Treatment Arm|Including treatment arm. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
11319409|NCT03289052|FG002|Participant Flow|Group B- Control Arm|Including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
11319410|NCT03289052|OG000|Outcome|Group A|The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site.
11319411|NCT03289052|OG001|Outcome|Group B-treatment Arm|Subject assigned in this group will receive Restylane Volyme treatment at D1.
11319412|NCT03289052|OG002|Outcome|Group B-control Arm|Subject assigned in this group will not receive Restylane Volyme treatment at D1 but on 6M visit.
11319413|NCT03289052|EG000|Reported Event|Group A|"The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site.~A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively."
11319414|NCT03289052|EG001|Reported Event|Group B-treatment Arm|including treatment arm A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
11319415|NCT03289052|EG002|Reported Event|Group B-control Arm|including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment.
11319416|NCT03289208|BG000|Baseline|Mild Renal Function Group|Mild renal function defined as eGFR 60-89 mL/min/1.73m^2
11319417|NCT03289208|BG001|Baseline|Moderate Renal Function Group|Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2
11319418|NCT03289208|BG002|Baseline|Normal Renal Function Group|Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
11319419|NCT03289208|BG003|Baseline|Total|Total of all reporting groups
11319420|NCT03289208|FG000|Participant Flow|Mild Renal Function Group|Mild renal function defined as eGFR 60-89 mL/min/1.73m^2
11319421|NCT03289208|FG001|Participant Flow|Moderate Renal Function Group|Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2
11319422|NCT03289208|FG002|Participant Flow|Normal Renal Function Group|Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
11319423|NCT03289208|OG000|Outcome|Mild Renal Function Group|Mild renal function defined as eGFR 60-89 mL/min/1.73m^2
11319424|NCT03289208|OG001|Outcome|Moderate Renal Function Group|Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2
11319425|NCT03289208|OG002|Outcome|Normal Renal Function Group|Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
11319426|NCT03289208|EG000|Reported Event|Mild Renal Function Group|Mild renal function defined as eGFR 60-89 mL/min/1.73m^2
11319427|NCT03289208|EG001|Reported Event|Moderate Renal Function Group|Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2
11319428|NCT03289208|EG002|Reported Event|Normal Renal Function Group|Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
11319429|NCT03289234|BG000|Baseline|Mild Hepatic Impairment|Child-Pugh score of 5 or 6
11319430|NCT03289234|BG001|Baseline|Moderate Hepatic Impairment|Child-Pugh score between 7 and 9
11319431|NCT03289234|BG002|Baseline|Normal Hepatic Function|normal hepatic function
11319432|NCT03289234|BG003|Baseline|Total|Total of all reporting groups
11319433|NCT03289234|FG000|Participant Flow|Mild Hepatic Impairment|Child-Pugh score of 5 or 6
11319434|NCT03289234|FG001|Participant Flow|Moderate Hepatic Impairment|Child-Pugh score between 7 and 9
11319435|NCT03289234|FG002|Participant Flow|Normal Hepatic Function|normal hepatic function
11319436|NCT03289234|OG000|Outcome|Mild Hepatic Impairment|Child-Pugh score of 5 or 6
11319437|NCT03289234|OG001|Outcome|Moderate Hepatic Impairment|Child-Pugh score between 7 and 9
11319438|NCT03289234|OG002|Outcome|Normal Hepatic Function|normal hepatic function
11319439|NCT03289234|EG000|Reported Event|Mild Hepatic Impairment|Child-Pugh score of 5 or 6
11319440|NCT03289234|EG001|Reported Event|Moderate Hepatic Impairment|Child-Pugh score between 7 and 9
11319441|NCT03289234|EG002|Reported Event|Normal Hepatic Function|normal hepatic function
11319442|NCT03289455|BG000|Baseline|1x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 0.3 to 2x10^6 CD19/CD22 CAR-positive T cells
11319443|NCT03289455|BG001|Baseline|3x10^6 CD19/CD22 CAR-positive T Cells/kg|All patients assigned in this Cohort received actual doses of 3x10^6 CD19/CD22 CAR-positive T cells
11319444|NCT03289455|BG002|Baseline|5x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 4.3 to 5x10^6 CD19/CD22 CAR-positive T cells
11319445|NCT03289455|BG003|Baseline|Total|Total of all reporting groups
11319446|NCT03289455|FG000|Participant Flow|1x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 0.3 to 2x10^6 CD19/CD22 CAR-positive T cells
11319447|NCT03289455|FG001|Participant Flow|3x10^6 CD19/CD22 CAR-positive T Cells/kg|All patients assigned in this Cohort received actual doses of 3x10^6 CD19/CD22 CAR-positive T cells
11319448|NCT03289455|FG002|Participant Flow|5x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 4.3 to 5x10^6 CD19/CD22 CAR-positive T cells
11319449|NCT03289455|OG000|Outcome|1x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 0.3 to 2x10^6 CD19/CD22 CAR-positive T cells
11319450|NCT03289455|OG001|Outcome|3x10^6 CD19/CD22 CAR-positive T Cells/kg|All patients assigned in this Cohort received actual doses of 3x10^6 CD19/CD22 CAR-positive T cells
11319451|NCT03289455|OG002|Outcome|5x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 4.3 to 5x10^6 CD19/CD22 CAR-positive T cells
11319452|NCT03289455|OG000|Outcome|AUTO3|Pediatric and young adult patients with relapsed or refractory B cell ALL
11319453|NCT03289455|EG000|Reported Event|1x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 0.3 to 2x10^6 CD19/CD22 CAR-positive T cells
11319454|NCT03289455|EG001|Reported Event|3x10^6 CD19/CD22 CAR-positive T Cells/kg|All patients assigned in this Cohort received actual doses of 3x10^6 CD19/CD22 CAR-positive T cells
11319455|NCT03289455|EG002|Reported Event|5x10^6 CD19/CD22 CAR-positive T Cells/kg|Patients assigned in this Cohort received actual doses of 4.3 to 5x10^6 CD19/CD22 CAR-positive T cells
11319456|NCT03289481|BG000|Baseline|Active Lozenge First|"Subject will take active lozenge for one week, perform cardiac testing then take placebo lozenge for one week and perform cardiac testing.~Active lozenge: nitric oxide generating lozenge"
11319457|NCT03289481|BG001|Baseline|Placebo Lozenge First|"Subject will take placebo lozenge for one week, perform cardiac testing then take active lozenge for one week and perform cardiac testing.~Active lozenge: nitric oxide generating lozenge"
11319458|NCT03289481|BG002|Baseline|Total|Total of all reporting groups
11319459|NCT03289481|FG000|Participant Flow|Active Lozenge First|"Subject will take active lozenge for one week, perform cardiac testing then take placebo lozenge for one week and perform cardiac testing.~Active lozenge: nitric oxide generating lozenge"
11319460|NCT03289481|FG001|Participant Flow|Placebo Lozenge First|"Subject will take placebo lozenge for one week, perform cardiac testing then take active lozenge for one week and perform cardiac testing.~Active lozenge: nitric oxide generating lozenge"
11319461|NCT03289481|OG000|Outcome|Active Lozenge|Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
11319462|NCT03289481|OG001|Outcome|Placebo|Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
11319463|NCT03289481|OG001|Outcome|Placebo Lozenge|Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
11319464|NCT03289481|EG000|Reported Event|Active Lozenge|Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
11319465|NCT03289481|EG001|Reported Event|Placebo Lozenge|Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
11319466|NCT03289533|BG000|Baseline|Avelumab + Axitinib|Participants with advanced HCC were administered with Avelumab 10 mg/kg as 1-hour IV infusion, on Day 1 of each cycle along with Axitinib 5 mg oral tablets, twice daily on a continuous dosing schedule (without a break in dosing except in case of drug-related toxicity) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the sponsor, whichever occurred first (up to maximum of 40 cycles). Duration of each cycle =14 days.
11333369|NCT03512457|OG000|Outcome|Intensive Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.~Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure."
11319467|NCT03289533|FG000|Participant Flow|Avelumab + Axitinib|Participants with advanced HCC were administered with Avelumab 10 milligram per kilogram (mg/kg) as 1-hour intravenous (IV) infusion, on Day 1 of each cycle along with Axitinib 5 milligram (mg) oral tablets, twice daily on a continuous dosing schedule (without a break in dosing except in case of drug-related toxicity) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the sponsor, whichever occurred first (up to maximum of 40 cycles). Duration of each cycle =14 days.
11319468|NCT03289533|OG000|Outcome|Avelumab + Axitinib|Participants with advanced HCC were administered with Avelumab 10 mg/kg as 1-hour IV infusion, on Day 1 of each cycle along with Axitinib 5 mg oral tablets, twice daily on a continuous dosing schedule (without a break in dosing except in case of drug-related toxicity) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the sponsor, whichever occurred first (up to maximum of 40 cycles). Duration of each cycle =14 days.
11319469|NCT03289533|EG000|Reported Event|Avelumab + Axitinib|Participants with advanced HCC were administered with Avelumab 10 mg/kg as 1-hour IV infusion, on Day 1 of each cycle along with Axitinib 5 mg oral tablets, twice daily on a continuous dosing schedule (without a break in dosing except in case of drug-related toxicity) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the sponsor, whichever occurred first (up to maximum of 40 cycles). Duration of each cycle =14 days.
11319470|NCT03289676|BG000|Baseline|Quitting Smoking Video|This arm watched a film in which six women living with HIV talk about why they decided to quit smoking and how they did.
11319471|NCT03289676|BG001|Baseline|HIV Infection Video|This arm watched an attention-control film in which four women talk about their everyday lives before and after the diagnosis of HIV.
11319472|NCT03289676|BG002|Baseline|Total|Total of all reporting groups
11319473|NCT03289676|FG000|Participant Flow|Quitting Smoking Film|"This arm viewed a storytelling narrative film of six women living with HIV taking about their success in quitting smoking.~A total of 27 women were randomized into this arm and four women withdrew from the study right before receiving any of the allotted intervention.~Of the remaining 23 women, 18 women received at least 80% of the allotted intervention, and all 23 women completed the study without any more loss.~Outcome analysis was done separately with 27 women who were randomized into the arm and with 23 women who actually received any part of the allotted intervention."
11319474|NCT03289676|FG001|Participant Flow|HIV Infection (an Attnetion-control) Film|"This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.~A total of 26 women were randomized into this arm and 20 women received at least 80% of the allotted intervention. One was lost during the follow-up period and 25 women completed the study.~Outcome analysis was done with 26 women who were randomized into the arm."
11319475|NCT03289676|OG000|Outcome|Quitting Smoking Video|"This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.~Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by Star story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection."
11319476|NCT03289676|OG001|Outcome|HIV Infection Video|"This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.~Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by Star story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection."
10827777|NCT00111813|OG003|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
10827778|NCT00111813|OG004|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11319477|NCT03289676|EG000|Reported Event|Quitting Smoking Video|This arm received a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
11319478|NCT03289676|EG001|Reported Event|HIV Infection Video|This arm watched an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
11319479|NCT03289858|BG000|Baseline|Exparel (Liposomal Bupivacaine)|"Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of single-dose infiltration into the surgical site to produce postsurgical analgesia.~Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture"
11319480|NCT03289858|BG001|Baseline|Saline Control|"Saline Solution (Sodium Chloride)~Sodium Chloride: Saline Injection"
11319481|NCT03289858|BG002|Baseline|Total|Total of all reporting groups
11319482|NCT03289858|FG000|Participant Flow|Exparel (Liposomal Bupivacaine)|"Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of single-dose infiltration into the surgical site to produce postsurgical analgesia.~Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture"
11319483|NCT03289858|FG001|Participant Flow|Saline Control|"Saline Solution (Sodium Chloride)~Sodium Chloride: Saline Injection"
11319484|NCT03289858|OG000|Outcome|Exparel (Liposomal Bupivacaine)|"Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of single-dose infiltration into the surgical site to produce postsurgical analgesia.~Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture"
11319485|NCT03289858|OG001|Outcome|Saline Control|"Saline Solution (Sodium Chloride)~Sodium Chloride: Saline Injection"
11319486|NCT03289858|EG000|Reported Event|Exparel (Liposomal Bupivacaine)|"Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of single-dose infiltration into the surgical site to produce postsurgical analgesia.~Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture"
11319487|NCT03289858|EG001|Reported Event|Saline Control|"Saline Solution (Sodium Chloride)~Sodium Chloride: Saline Injection"
11319488|NCT03290027|BG000|Baseline|Active|"DFD-03 (0.1% tazarotene) Lotion~DFD-03: DFD-03 Lotion"
11319489|NCT03290027|BG001|Baseline|Vehicle|"Vehicle (0% tazarotene) Lotion~Placebo Comparator: Vehicle (tazarotene 0%) Lotion"
11319490|NCT03290027|BG002|Baseline|Total|Total of all reporting groups
11319491|NCT03290027|FG000|Participant Flow|Active|"DFD-03 (0.1% tazarotene) Lotion~DFD-03: DFD-03 Lotion"
11319492|NCT03290027|FG001|Participant Flow|Vehicle|"Vehicle (0% tazarotene) Lotion~Placebo Comparator: Vehicle (tazarotene 0%) Lotion"
11319493|NCT03290027|OG000|Outcome|Active|"DFD-03 (0.1% tazarotene) Lotion~DFD-03: DFD-03 Lotion"
11319494|NCT03290027|OG001|Outcome|Vehicle|"Vehicle (0% tazarotene) Lotion~Placebo Comparator: Vehicle (tazarotene 0%) Lotion"
11319495|NCT03290027|EG000|Reported Event|Active|"DFD-03 (0.1% tazarotene) Lotion~DFD-03: DFD-03 Lotion"
11319496|NCT03290027|EG001|Reported Event|Vehicle|"Vehicle (0% tazarotene) Lotion~Placebo Comparator: Vehicle (tazarotene 0%) Lotion"
11319497|NCT03290300|BG000|Baseline|Long-Term Study Subjects|"This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.~Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus"
11319498|NCT03290300|FG000|Participant Flow|Long-Term Study Subjects|"This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study (NCT02914236), who consented to continue to provide quality of life data.~Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus"
11319499|NCT03290300|OG000|Outcome|Long-Term Study Subjects - 12 Month Data|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and were enrolled in this study within the 12-month post-procedure window.
11319500|NCT03290300|OG001|Outcome|Long-Term Study Subjects - 18 Month Data|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window.
11319501|NCT03290300|OG002|Outcome|Long-Term Study Subjects - 24 Month Data|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window.
11319502|NCT03290300|OG000|Outcome|Long-Term Study Subjects - 12 Month|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 12 months post-procedure
11319503|NCT03290300|OG001|Outcome|Long-Term Study Subjects - 18 Month Data|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 18 months post-procedure
11319504|NCT03290300|OG002|Outcome|Long-Term Study Subjects - 24 Month Data|This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 24 months post-procedure
11319505|NCT03290300|EG000|Reported Event|Long-Term Study Subjects|"This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data.~Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus"
11319506|NCT03290378|BG000|Baseline|AVE-901 50 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319507|NCT03290378|BG001|Baseline|AVE-901 25 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319508|NCT03290378|BG002|Baseline|Placebo|Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319509|NCT03290378|BG003|Baseline|Total|Total of all reporting groups
11319510|NCT03290378|FG000|Participant Flow|AVE-901 50 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319511|NCT03290378|FG001|Participant Flow|AVE-901 25 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319512|NCT03290378|FG002|Participant Flow|Placebo|Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319513|NCT03290378|OG000|Outcome|AVE-901 50 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319514|NCT03290378|OG001|Outcome|AVE-901 25 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319515|NCT03290378|OG002|Outcome|Placebo|Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319516|NCT03290378|EG000|Reported Event|AVE-901 50 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319517|NCT03290378|EG001|Reported Event|AVE-901 25 mg|Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319518|NCT03290378|EG002|Reported Event|Placebo|Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
11319519|NCT03290768|BG000|Baseline|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11319520|NCT03290768|FG000|Participant Flow|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11319521|NCT03290768|OG000|Outcome|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11319522|NCT03290768|EG000|Reported Event|Diabetes Management Educational Program|"Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.~Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.~Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.~Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging."
11319523|NCT03291041|BG000|Baseline|Tasimelteon|"tasimelteon, administered as oral capsule(s)~Tasimelteon: capsule"
11319524|NCT03291041|BG001|Baseline|Placebo|"Placebo, administered as oral capsule(s)~Placebo: capsule"
11319525|NCT03291041|BG002|Baseline|Total|Total of all reporting groups
11319526|NCT03291041|FG000|Participant Flow|Tasimelteon|"tasimelteon, administered as oral capsule(s)~Tasimelteon: capsule"
11319527|NCT03291041|FG001|Participant Flow|Placebo|"Placebo, administered as oral capsule(s)~Placebo: capsule"
11319528|NCT03291041|OG000|Outcome|Tasimelteon|"tasimelteon, administered as oral capsule(s)~Tasimelteon: capsule"
11319529|NCT03291041|OG001|Outcome|Placebo|"Placebo, administered as oral capsule(s)~Placebo: capsule"
11319530|NCT03291041|EG000|Reported Event|Tasimelteon|"tasimelteon, administered as oral capsule(s)~Tasimelteon: capsule"
11319531|NCT03291041|EG001|Reported Event|Placebo|"Placebo, administered as oral capsule(s)~Placebo: capsule"
11319532|NCT03291080|BG000|Baseline|Liquid First|Oral liquid formulation of 13-Cis Retinoic Acid (test product) administered in Cycle 1, then 13-CRA extracted capsules (reference product) administered in Cycle 2. The daily dose in each cycle was 200mg per m^2 (in 2 divided doses), reduced to 160 mg per m^2 if weight < 12 kg
11319533|NCT03291080|BG001|Baseline|Extracted Capsule First|13-CRA extracted capsules (reference product) administered in Cycle 1, then oral liquid formulation of 13-Cis Retinoic Acid (test product) administered in Cycle 2. The daily dose in each cycle was 200mg per m^2 (in 2 divided doses), reduced to 160 mg per m^2 if weight < 12 kg
11319534|NCT03291080|BG002|Baseline|Total|Total of all reporting groups
11319535|NCT03291080|FG000|Participant Flow|First Oral Liquid, Then Capsule|Oral liquid formulation of 13-Cis Retinoic Acid (test product) in the first cycle. Then extracted 13-CRA capsule (reference product) in the second cycle.
11319536|NCT03291080|FG001|Participant Flow|First Capsule, Then Oral Liquid|13-CRA capsules extracted per standard of care (reference product) in the first cycle. Then oral liquid formulation of 13-CRA (test product) in the second cycle.
11319537|NCT03291080|OG000|Outcome|13-CRA Oral Liquid|Oral liquid formulation - test product
11319538|NCT03291080|OG001|Outcome|13-CRA Extracted Capsule|Oral liquid formulation - reference product
11319539|NCT03291080|OG001|Outcome|13-CRA Extracted Capsule|Extracted Capsules- reference product
11319540|NCT03291080|EG000|Reported Event|13-CRA Oral Liquid|Oral liquid formulation - test product
11319541|NCT03291080|EG001|Reported Event|13-CRA Extracted Capsule|Oral liquid formulation - reference product
11319542|NCT03291197|BG000|Baseline|Open Label Treatment|"These patients will receive suprascapular and median nerve blocks for shoulder hand syndrome. Investigators will assess the tolerability of his procedure using pre-defined criteria (outlined elsewhere).~Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side.~Outcome measure were recorded for each participant before, immediately after, and 2 weeks post intervention."
11319543|NCT03291197|FG000|Participant Flow|Open Label Treatment|"These patients received suprascapular and median nerve blocks for shoulder hand syndrome. Investigators assessed the tolerability of his procedure using pre-defined criteria (outlined elsewhere).~Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side."
11319544|NCT03291197|OG000|Outcome|Tolerability|Composite score of: a) change in VAS by > 18mm; b) rate of serious adverse events; c) level of patient satisfaction
11319545|NCT03291197|OG000|Outcome|Baseline VAS|visual analog pain scale at baseline prior to intervention
11319546|NCT03291197|OG001|Outcome|1 Hour VAS|VAS measured within 1 hour after intervetion
11319547|NCT03291197|OG002|Outcome|2 Weeks VAS|VAS measured 2 weeks post intervention
11319548|NCT03291197|OG000|Outcome|All Participants|All participants will be assessed using the Budapest Criteria by both a staff physician and a resident. The inter-rater agreement will be determined to assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS.
11319549|NCT03291197|EG000|Reported Event|Tolerability|Composite score
11319550|NCT03291288|BG000|Baseline|All Participants|All participants who received pexidartinib in Part 1 and Part 2 of the study.
11319551|NCT03291288|FG000|Participant Flow|Part 1: Drug-drug Interaction Phase|"On Day 1, participants received the single oral dose of midazolam (2 mg) and tolbutamide (500 mg).~On Day 3, pexidartinib (800 mg/day) administered as 400 mg twice daily (BID) was initiated and continued throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning pexidartinib dose (400 mg).~On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning dose of pexidartinib (400 mg)."
11319552|NCT03291288|FG001|Participant Flow|Part 2: Pexidartinib Only|All participants received pexidartinib twice daily (BID) dosing in 28-day cycles at the 400 mg/day dose for up to one year.
11319553|NCT03291288|OG000|Outcome|Part 1: Midazolam Only|All participants received a single oral dose of midazolam (2 mg) on Day 1.
11319554|NCT03291288|OG001|Outcome|Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1)|All participants received a single oral dose of midazolam (2 mg) on Day 3 concomitantly with pexidartinib and on Day 13 following approximately 10 days of pexidartinib twice daily (BID) dosing.
11319555|NCT03291288|OG002|Outcome|Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11)|All participants received a single oral dose of midazolam (2 mg) on Day 3 concomitantly with pexidartinib and on Day 13 following approximately 10 days of pexidartinib twice daily (BID) dosing.
11319556|NCT03291288|OG000|Outcome|Part 1: Tolbutamide Only|All participants received a single oral dose of tolbutamide (500 mg) on Day 1.
11319557|NCT03291288|OG001|Outcome|Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1)|All participants received a single oral dose of tolbutamide (500 mg) concomitantly with pexidartinib and on Days 3 and 13 following approximately 10 days of pexidartinib twice daily (BID) dosing.
11319558|NCT03291288|OG002|Outcome|Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11)|All participants received a single oral dose of tolbutamide (500 mg) concomitantly with pexidartinib and on Days 3 and 13 following approximately 10 days of pexidartinib twice daily (BID) dosing.
11319559|NCT03291288|OG000|Outcome|Part 1: Drug-drug Interaction Phase|"On Day 1, participants received the single oral dose of midazolam (2 mg) and tolbutamide (500 mg).~On Day 3, pexidartinib (800 mg/day) administered as 400 mg twice daily (BID) was initiated and continued throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning pexidartinib dose (400 mg).~On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning dose of pexidartinib (400 mg)."
11319560|NCT03291288|OG001|Outcome|Part 2: Pexidartinib Only|All participants received pexidartinib twice daily (BID) dosing in 28-day cycles at the 400 mg/day dose for up to one year.
11319561|NCT03291288|OG000|Outcome|Part 1: Pexidartinib (Cycle 1, Day 1)|Pexidartinib was administered orally as a total daily dose of 800 mg (400 mg BID) starting from Day 3.
11319562|NCT03291288|OG001|Outcome|Part 1: Pexidartinib (Cycle 1, Day 11)|Pexidartinib was administered orally as a total daily dose of 800 mg (400 mg BID) starting from Day 3.
11319563|NCT03291288|EG000|Reported Event|Part 1: Drug-drug Interaction Phase|"On Day 1, participants received the single oral dose of midazolam (2 mg) and tolbutamide (500 mg).~On Day 3, pexidartinib (800 mg/day) administered as 400 mg twice daily (BID) was initiated and continued throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning pexidartinib dose (400 mg).~On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning dose of pexidartinib (400 mg)."
11319564|NCT03291288|EG001|Reported Event|Part 2: Pexidartinib Only|All participants received pexidartinib twice daily (BID) dosing in 28-day cycles at the 400 mg/day dose for up to one year.
11319565|NCT03291379|BG000|Baseline|BTG-002814|"Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)~BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib"
11319566|NCT03291379|FG000|Participant Flow|BTG-002814|"Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)~BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib"
11319567|NCT03291379|OG000|Outcome|BTG-002814|"Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)~BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib"
11319568|NCT03291379|OG000|Outcome|BTG-002814|"Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)~BTG-002814: BTG-002814 containing 100 mg vandetanib"
11319569|NCT03291379|EG000|Reported Event|BTG-002814|"Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)~BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib"
11319570|NCT03291613|BG000|Baseline|Pinpoint App Usability Testing|Participants used the Pinpoint tablet app for one hour.
11319571|NCT03291613|FG000|Participant Flow|Pinpoint App Usability Testing|Participants used the Pinpoint tablet app for one hour.
11319572|NCT03291613|OG000|Outcome|Pinpoint App|"Tablet application.~Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool."
11319573|NCT03291613|EG000|Reported Event|Pinpoint App|"Tablet application.~Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool."
11319574|NCT03292016|BG000|Baseline|APL-130277, Then APOKYN, Then APO-go|Sequence 1: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go ( same dose as APOKYN: 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319575|NCT03292016|BG001|Baseline|APL-130277, Then APO-go, Then APOKYN|Sequence 2: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319576|NCT03292016|BG002|Baseline|APOKYN, Then APL-130277, Then APO-go|Sequence 3: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319577|NCT03292016|BG003|Baseline|APOKYN, Then APO-go, Then APL-130277|Sequence 4: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.
11319578|NCT03292016|BG004|Baseline|APO-go, Then APL-130277, Then APOKYN|Sequence 5: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319579|NCT03292016|BG005|Baseline|APO-go, Then APOKYN, Then APL-130277|Sequence 6: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.
11319580|NCT03292016|BG006|Baseline|Total|Total of all reporting groups
11319581|NCT03292016|FG000|Participant Flow|APL-130277, Then APOKYN, Then APO-go|Sequence 1: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go ( same dose as APOKYN: 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319582|NCT03292016|FG001|Participant Flow|APL-130277, Then APO-go, Then APOKYN|Sequence 2: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319583|NCT03292016|FG002|Participant Flow|APOKYN, Then APL-130277, Then APO-go|Sequence 3: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319584|NCT03292016|FG003|Participant Flow|APOKYN, Then APO-go, Then APL-130277|Sequence 4: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.
11319585|NCT03292016|FG004|Participant Flow|APO-go, Then APL-130277, Then APOKYN|Sequence 5: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.
11319586|NCT03292016|FG005|Participant Flow|APO-go, Then APOKYN, Then APL-130277|Sequence 6: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.
11319587|NCT03292016|OG000|Outcome|APL-130277, Sublingual Thin Film|APL-130277, sublingual thin film, once daily
11319588|NCT03292016|OG001|Outcome|Subcutaneous APOKYN|Subcutaneous APOKYN, once daily
11319589|NCT03292016|OG002|Outcome|Subcutaneous APO-go|Subcutaneous APO-go, once daily
11319590|NCT03292016|EG000|Reported Event|APL-130277, Sublingual Thin Film|APL-130277, sublingual thin film, once daily
11319591|NCT03292016|EG001|Reported Event|Subcutaneous APOKYN|Subcutaneous APOKYN, once daily
11319592|NCT03292016|EG002|Reported Event|Subcutaneous APO-go|Subcutaneous APO-go, once daily
11319593|NCT03292406|BG000|Baseline|CD11301 Gel 0.06%|Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319594|NCT03292406|BG001|Baseline|CD11301 Gel 0.03%|Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319595|NCT03292406|BG002|Baseline|Placebo|Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
11319596|NCT03292406|BG003|Baseline|Total|Total of all reporting groups
11319597|NCT03292406|FG000|Participant Flow|CD11301 Gel 0.06%|Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319598|NCT03292406|FG001|Participant Flow|CD11301 Gel 0.03%|Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319599|NCT03292406|FG002|Participant Flow|Placebo|Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
11319600|NCT03292406|OG000|Outcome|CD11301 Gel 0.06%|Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319601|NCT03292406|OG001|Outcome|CD11301 Gel 0.03%|Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319602|NCT03292406|OG002|Outcome|Placebo|Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
11319603|NCT03292406|EG000|Reported Event|CD11301 Gel 0.06%|Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319604|NCT03292406|EG001|Reported Event|CD11301 Gel 0.03%|Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
11319605|NCT03292406|EG002|Reported Event|Placebo|Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
11319606|NCT03292432|BG000|Baseline|Standard of Care (SOC)|Standard of care for adherence support at site
11319607|NCT03292432|BG001|Baseline|TERA Intervention (TERA)|Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
11319608|NCT03292432|BG002|Baseline|Total|Total of all reporting groups
11319609|NCT03292432|FG000|Participant Flow|Standard of Care (SOC)|Standard of care for adherence support at site
11319610|NCT03292432|FG001|Participant Flow|TERA Intervention (TERA)|Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
11319611|NCT03292432|OG000|Outcome|Standard of Care (SOC)|Standard of care for adherence support at site
11319612|NCT03292432|OG001|Outcome|TERA Intervention (TERA)|Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
11319613|NCT03292432|EG000|Reported Event|Standard of Care (SOC)|Standard of care for adherence support at site
11319614|NCT03292432|EG001|Reported Event|TERA Intervention (TERA)|Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks
11319615|NCT03292562|BG000|Baseline|Discontinue NCPAP After Weaning Pressures|"After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again."
11319616|NCT03292562|BG001|Baseline|Discontinue NCPAP Without Weaning Pressures|"After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2)."
11319617|NCT03292562|BG002|Baseline|Total|Total of all reporting groups
11319618|NCT03292562|FG000|Participant Flow|Discontinue NCPAP After Weaning Pressures|After randomization, continuous positive airway pressure (CPAP) will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).
11319619|NCT03292562|FG001|Participant Flow|Discontinue NCPAP Without Weaning Pressures|After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).
11319620|NCT03292562|OG000|Outcome|Discontinue NCPAP After Weaning Pressures|"After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again."
11319621|NCT03292562|OG001|Outcome|Discontinue NCPAP Without Weaning Pressures|"After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2)."
11319622|NCT03292562|EG000|Reported Event|Discontinue NCPAP After Weaning Pressures|"After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again."
11319623|NCT03292562|EG001|Reported Event|Discontinue NCPAP Without Weaning Pressures|"After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).~Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2)."
11319624|NCT03292614|BG000|Baseline|Multifocal Intraocular Lens Implantation|Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction
11319625|NCT03292614|FG000|Participant Flow|Multifocal Intraocular Lens Implantation|Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction
11319626|NCT03292614|OG000|Outcome|Multifocal Intraocular Lens Implantation|Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction
11319627|NCT03292614|EG000|Reported Event|Multifocal Intraocular Lens Implantation|Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction
11319628|NCT03292640|BG000|Baseline|DFD-03 Lotion (0.1% Tazarotene)|DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319629|NCT03292640|BG001|Baseline|DFD-03 Vehicle (0% Tazarotene)|DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319630|NCT03292640|BG002|Baseline|Total|Total of all reporting groups
11319631|NCT03292640|FG000|Participant Flow|DFD-03 Lotion (0.1% Tazarotene)|DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319632|NCT03292640|FG001|Participant Flow|DFD-03 Vehicle (0% Tazarotene)|DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319633|NCT03292640|OG000|Outcome|DFD-03 Lotion (0.1% Tazarotene)|DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319634|NCT03292640|OG001|Outcome|DFD-03 Vehicle (0% Tazarotene)|DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319635|NCT03292640|OG000|Outcome|DFD-03 Lotion (0.1% Tazarotene)|DFD-03 (0.1% tazarotene) Lotion: Subjects applied a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. After a short time, the subject rinsed off the product with warm water. This procedure was followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319636|NCT03292640|OG001|Outcome|DFD-03 Vehicle (0% Tazarotene)|DFD-03 (0% tazarotene) Lotion (Placebo): Subjects applied a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. After a short time, the subject rinsed off the product with warm water. This procedure was followed twice daily, in the morning and at bedtime, approximately 12 hours apart.
11319637|NCT03292640|OG000|Outcome|DFD-03 Lotion (0.1% Tazarotene)|"DFD-03 Lotion (0.1% tazarotene)~DFD-03 (0.1% tazarotene) Lotion: DFD-03 Lotion (0.1% tazarotene) - twice daily application"
11319638|NCT03292640|OG001|Outcome|DFD-03 Vehicle (0% Tazarotene)|"DFD-03 Vehicle Lotion (0% tazarotene)~DFD-03 (0% tazarotene) Lotion (Placebo): DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application"
11319639|NCT03292640|EG000|Reported Event|DFD-03 Lotion (0.1% Tazarotene)|DFD-03 (0.1% tazarotene) Lotion was to be applied twice daily for 12 weeks
11319640|NCT03292640|EG001|Reported Event|DFD-03 Vehicle (0% Tazarotene)|DFD-03 Vehicle Lotion (0% tazarotene) was to be applied twice daily for 12 weeks
11319641|NCT03292653|BG000|Baseline|Placebo|Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319642|NCT03292653|BG001|Baseline|Sotagliflozin 200 mg|Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319643|NCT03292653|BG002|Baseline|Sotagliflozin 400 mg|Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319644|NCT03292653|BG003|Baseline|Total|Total of all reporting groups
11319645|NCT03292653|FG000|Participant Flow|Placebo|Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319646|NCT03292653|FG001|Participant Flow|Sotagliflozin 200 mg|Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319647|NCT03292653|FG002|Participant Flow|Sotagliflozin 400 mg|Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319648|NCT03292653|OG000|Outcome|Placebo|Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319649|NCT03292653|OG001|Outcome|Sotagliflozin 200 mg|Participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319650|NCT03292653|OG002|Outcome|Sotagliflozin 400 mg|Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319651|NCT03292653|OG002|Outcome|Sotagliflozin 400 mg|Participants were randomized to sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319652|NCT03292653|EG000|Reported Event|Placebo|Participants were randomized to matching placebo to sotagliflozin administered as two tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319653|NCT03292653|EG001|Reported Event|Sotagliflozin 200 mg|Participants were randomized to Sotagliflozin 200 mg tablet administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319654|NCT03292653|EG002|Reported Event|Sotagliflozin 400 mg|Participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 14 days.
11319655|NCT03292692|BG000|Baseline|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
11319656|NCT03292692|BG001|Baseline|Waitlist Control|2 month waiting period before couples can receive intervention
11319657|NCT03292692|BG002|Baseline|Total|Total of all reporting groups
11319658|NCT03292692|FG000|Participant Flow|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
11319659|NCT03292692|FG001|Participant Flow|Waitlist Control|2 month waiting period before couples can receive intervention
11319660|NCT03292692|OG000|Outcome|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
11319661|NCT03292692|OG001|Outcome|Waitlist Control|2 month waiting period before couples can receive intervention
11319662|NCT03292692|EG000|Reported Event|OurRelationship|"Online Intervention~OurRelationship: Online intervention with coach support"
11319663|NCT03292692|EG001|Reported Event|Waitlist Control|2 month waiting period before couples can receive intervention
11319664|NCT03292809|BG000|Baseline|CyclASol Ophthalmic Solution|"Cylclosporine A solution in vehicle~CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle"
11319665|NCT03292809|BG001|Baseline|Vehicle Ophthalmic Solution|"Vehicle only~Vehicle topical ocular, eye drops: Vehicle"
11319666|NCT03292809|BG002|Baseline|Total|Total of all reporting groups
11319667|NCT03292809|FG000|Participant Flow|CyclASol Ophthalmic Solution|"Cylclosporine A solution in vehicle~CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle"
11319668|NCT03292809|FG001|Participant Flow|Vehicle Ophthalmic Solution|"Vehicle only~Vehicle topical ocular, eye drops: Vehicle"
11319669|NCT03292809|OG000|Outcome|CyclASol Ophthalmic Solution|"Cylclosporine A solution in vehicle~CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle"
11319670|NCT03292809|OG001|Outcome|Vehicle Ophthalmic Solution|"Vehicle only~Vehicle topical ocular, eye drops: Vehicle"
11319671|NCT03292809|EG000|Reported Event|CyclASol Ophthalmic Solution|"Cylclosporine A solution in vehicle~CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle"
11319672|NCT03292809|EG001|Reported Event|Vehicle Ophthalmic Solution|"Vehicle only~Vehicle topical ocular, eye drops: Vehicle"
11319673|NCT03292952|BG000|Baseline|Active Treatment|"KP415 oral capsule 20, 30 or 40 mg~KP415 oral capsule: Daily dose"
11319674|NCT03292952|BG001|Baseline|Placebo Treatment|"Placebo oral capsule~Placebo oral capsule: Daily dose"
11319675|NCT03292952|BG002|Baseline|Total|Total of all reporting groups
11319676|NCT03292952|FG000|Participant Flow|Open-Label KP415|Open-label titration with KP415 capsule 20, 30, or 40 mg once-daily for 3 weeks
11319677|NCT03292952|FG001|Participant Flow|Double-Blind KP415|"KP415 oral capsule 20, 30 or 40 mg~KP415 oral capsule: Daily dose"
11319678|NCT03292952|FG002|Participant Flow|Double-Blind Placebo|"Placebo oral capsule~Placebo oral capsule: Daily dose"
11319679|NCT03292952|OG000|Outcome|Active Treatment|"KP415 oral capsule 20, 30 or 40 mg~KP415 oral capsule: Daily dose"
11319680|NCT03292952|OG001|Outcome|Placebo Treatment|"Placebo oral capsule~Placebo oral capsule: Daily dose"
11319681|NCT03292952|OG000|Outcome|Double-Blind KP415|"KP415 oral capsule 20, 30 or 40 mg~KP415 oral capsule: Daily dose"
11319682|NCT03292952|OG001|Outcome|Double-Blind Placebo|"Placebo oral capsule~Placebo oral capsule: Daily dose"
11319683|NCT03292952|EG000|Reported Event|Open-Label KP415|"3-week titration period to identify an optimal dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule, once-daily:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11319684|NCT03292952|EG001|Reported Event|Double-Blind KP415|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule, once-daily:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11319685|NCT03292952|EG002|Reported Event|Double-Blind Placebo|Double-Blind Placebo, once-daily
11319686|NCT03293238|BG000|Baseline|Joint Line Ultrasound|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.~Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance."
11319687|NCT03293238|BG001|Baseline|Joint Line Landmark|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.~Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician."
11319688|NCT03293238|BG002|Baseline|Suprapatellar Ultrasound Guided|"Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.~Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch."
11319689|NCT03293238|BG003|Baseline|Suprapatellar Landmark|"Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.~Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch."
11319690|NCT03293238|BG004|Baseline|Total|Total of all reporting groups
11319691|NCT03293238|FG000|Participant Flow|Joint Line Ultrasound|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.~Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance."
11319692|NCT03293238|FG001|Participant Flow|Joint Line Landmark|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.~Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician."
11319693|NCT03293238|FG002|Participant Flow|Suprapatellar Ultrasound Guided|"Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.~Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch."
11319694|NCT03293238|FG003|Participant Flow|Suprapatellar Landmark|"Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.~Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch."
11319695|NCT03293238|OG000|Outcome|Joint Line Ultrasound|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.~Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance."
11319696|NCT03293238|OG001|Outcome|Joint Line Landmark|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.~Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician."
11319697|NCT03293238|OG002|Outcome|Suprapatellar Ultrasound Guided|"Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.~Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch."
11319698|NCT03293238|OG003|Outcome|Suprapatellar Landmark|"Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.~Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch."
11319699|NCT03293238|EG000|Reported Event|Joint Line Ultrasound|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.~Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance."
11319700|NCT03293238|EG001|Reported Event|Joint Line Landmark|"Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.~Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician."
11333370|NCT03512457|OG001|Outcome|Minimal Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.~Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure."
10827779|NCT00111813|OG005|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11319701|NCT03293238|EG002|Reported Event|Suprapatellar Ultrasound Guided|"Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.~Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch."
11319702|NCT03293238|EG003|Reported Event|Suprapatellar Landmark|"Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.~Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch."
11319703|NCT03293394|BG000|Baseline|Real tDCS|"10 days anodal bilateral motor cortex and cathodal spinal tDCS~Anodal bilateral motor cortex and cathodal spinal tDCS: 10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319704|NCT03293394|BG001|Baseline|Sham tDCS|"10 days sham bilateral motor cortex and sham spinal tDCS~Sham bilateral motor cortex and sham spinal tDCS: 10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11095180|NCT01556724|BG000|Baseline|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11319705|NCT03293394|BG002|Baseline|Total|Total of all reporting groups
11319706|NCT03293394|FG000|Participant Flow|Real tDCS|"10 days anodal bilateral motor cortex and cathodal spinal tDCS~Anodal bilateral motor cortex and cathodal spinal tDCS: 10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319707|NCT03293394|FG001|Participant Flow|Sham tDCS|"10 days sham bilateral motor cortex and sham spinal tDCS~Sham bilateral motor cortex and sham spinal tDCS: 10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319708|NCT03293394|OG000|Outcome|Real tDCS|"10 days anodal bilateral motor cortex and cathodal spinal tDCS~Anodal bilateral motor cortex and cathodal spinal tDCS: 10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319709|NCT03293394|OG001|Outcome|Sham tDCS|"10 days sham bilateral motor cortex and sham spinal tDCS~Sham bilateral motor cortex and sham spinal tDCS: 10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319710|NCT03293394|EG000|Reported Event|Real tDCS|"10 days anodal bilateral motor cortex and cathodal spinal tDCS~Anodal bilateral motor cortex and cathodal spinal tDCS: 10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319711|NCT03293394|EG001|Reported Event|Sham tDCS|"10 days sham bilateral motor cortex and sham spinal tDCS~Sham bilateral motor cortex and sham spinal tDCS: 10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)"
11319712|NCT03293485|BG000|Baseline|cIAI/cUTI|Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.
11319713|NCT03293485|FG000|Participant Flow|cIAI/cUTI|Participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI) received intravenous imipenem+cilastatin+relebactam (IMI/REL) once every 6 hours for 5-14 days.
11319714|NCT03293485|OG000|Outcome|cIAI/cUTI|Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.
11319715|NCT03293485|OG000|Outcome|cIAI|Participants with cIAI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.
11319716|NCT03293485|OG000|Outcome|cUTI|Participants with cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.
11319717|NCT03293485|EG000|Reported Event|cIAI/cUTI|Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.
11319718|NCT03293654|BG000|Baseline|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319719|NCT03293654|BG001|Baseline|US Licenced Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319720|NCT03293654|BG002|Baseline|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319721|NCT03293654|BG003|Baseline|Total|Total of all reporting groups
11319722|NCT03293654|FG000|Participant Flow|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319723|NCT03293654|FG001|Participant Flow|US Licenced Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319724|NCT03293654|FG002|Participant Flow|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319725|NCT03293654|OG000|Outcome|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319726|NCT03293654|OG001|Outcome|US Licenced Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319727|NCT03293654|OG002|Outcome|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319728|NCT03293654|EG000|Reported Event|MB02 (Bevacizumab Biosimilar)|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~MB02: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319729|NCT03293654|EG001|Reported Event|US Licenced Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319730|NCT03293654|EG002|Reported Event|EU Approved Avastin®|"Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.~EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion."
11319731|NCT03294213|BG000|Baseline|aScope 4 Broncho|"The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho~aScope 4 Broncho: Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use"
11319732|NCT03294213|FG000|Participant Flow|aScope 4 Broncho|"The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho~aScope 4 Broncho: Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use"
11319733|NCT03294213|OG000|Outcome|aScope 4 Broncho|"The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho~aScope 4 Broncho: Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use"
11319734|NCT03294213|EG000|Reported Event|aScope 4 Broncho|"The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho~aScope 4 Broncho: Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use"
11319735|NCT03294317|BG000|Baseline|His Bundle Pacing|"Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.~His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead"
11319736|NCT03294317|FG000|Participant Flow|His Bundle Pacing|"Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.~His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead"
11319737|NCT03294317|OG000|Outcome|His Bundle Pacing|"Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.~His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead"
11319738|NCT03294317|EG000|Reported Event|His Bundle Pacing|"Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.~His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead"
11319739|NCT03294538|BG000|Baseline|Generic Estradiol Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319740|NCT03294538|BG001|Baseline|Estrace Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319741|NCT03294538|BG002|Baseline|Vehicle Vaginal Cream|Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.
11319742|NCT03294538|BG003|Baseline|Total|Total of all reporting groups
11319743|NCT03294538|FG000|Participant Flow|Generic Estradiol Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319744|NCT03294538|FG001|Participant Flow|Estrace Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319745|NCT03294538|FG002|Participant Flow|Vehicle Vaginal Cream|Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.
11319746|NCT03294538|OG000|Outcome|Generic Estradiol Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319747|NCT03294538|OG001|Outcome|Estrace Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319748|NCT03294538|OG002|Outcome|Vehicle Vaginal Cream|Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.
11319749|NCT03294538|EG000|Reported Event|Generic Estradiol Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319750|NCT03294538|EG001|Reported Event|Estrace Vaginal Cream USP, 0.01%|Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
11319751|NCT03294538|EG002|Reported Event|Vehicle Vaginal Cream|Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.
11319752|NCT03294629|BG000|Baseline|CPAP w/SensAwake First, Then CPAP w/o SensAwake|Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.
11319753|NCT03294629|BG001|Baseline|CPAP w/o SensAwake First, Then CPAP w/SensAwake|Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.
11319754|NCT03294629|BG002|Baseline|Total|Total of all reporting groups
11319755|NCT03294629|FG000|Participant Flow|CPAP w/SensAwake First, Then CPAP w/o SensAwake|Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period.
11319756|NCT03294629|FG001|Participant Flow|CPAP w/o SensAwake First, Then CPAP w/SensAwake|Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period.
10827780|NCT00111813|EG000|Reported Event|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
11319757|NCT03294629|OG000|Outcome|SA ON|CPAP with SensAwake activation
11319758|NCT03294629|OG001|Outcome|SA OFF|CPAP without SensAwake activation
11319759|NCT03294629|EG000|Reported Event|SA ON|CPAP with SensAwake activation
11319760|NCT03294629|EG001|Reported Event|SA OFF|CPAP without SensAwake activation
11319761|NCT03294681|BG000|Baseline|Cochlear Implant Recipients|CI532 and CI512 cochlear implant recipients
11319762|NCT03294681|FG000|Participant Flow|Cochlear Implant Recipients|CI532 and CI512 cochlear implant recipients
11319763|NCT03294681|OG000|Outcome|Cochlear Implant Recipients|CI532 and CI512 cochlear implant recipients
11319764|NCT03294681|EG000|Reported Event|Cochlear Implant Recipients|CI532 and CI512 cochlear implant recipients
10827781|NCT00111813|EG001|Reported Event|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
10827782|NCT00111813|EG002|Reported Event|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
11319765|NCT03294850|BG000|Baseline|NASH Group|"These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319766|NCT03294850|BG001|Baseline|Non-NASH (NAFLD or Normal) Group|"These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319767|NCT03294850|BG002|Baseline|Total|Total of all reporting groups
11319768|NCT03294850|FG000|Participant Flow|NASH Group|"These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319769|NCT03294850|FG001|Participant Flow|Non-NASH (NAFLD or Normal) Group|"These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319770|NCT03294850|OG000|Outcome|NASH Group|"These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319771|NCT03294850|OG001|Outcome|Non-NASH (NAFLD or Normal) Group|"These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319772|NCT03294850|EG000|Reported Event|NASH Group|"These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319773|NCT03294850|EG001|Reported Event|Non-NASH (NAFLD or Normal) Group|"These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.~Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied~HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function."
11319774|NCT03294941|BG000|Baseline|HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319775|NCT03294941|BG001|Baseline|HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319776|NCT03294941|BG002|Baseline|Total|Total of all reporting groups
11319777|NCT03294941|FG000|Participant Flow|HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319778|NCT03294941|FG001|Participant Flow|HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319779|NCT03294941|OG000|Outcome|HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319780|NCT03294941|OG001|Outcome|HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319781|NCT03294941|OG000|Outcome|HepQuant SHUNT Liver Diagnostic Kit - Subjects With F3 Fibrosis|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319782|NCT03294941|OG001|Outcome|HepQuant SHUNT Liver Diagnostic Kit - Subjects With F4 Fibrosis|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319783|NCT03294941|EG000|Reported Event|HepQuant SHUNT Liver Diagnostic Kit|"All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test~HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks"
11319784|NCT03295201|BG000|Baseline|Pulmonary Rehabilitation+Exercise Group|"Active cycle of breathing techniques (ACBT) and postural exercise program~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.~Postural Exercise: Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks."
11319785|NCT03295201|BG001|Baseline|Pulmonary Rehabilitation Group|"Active cycle of breathing techniques (ACBT)~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks."
11319786|NCT03295201|BG002|Baseline|Total|Total of all reporting groups
11333371|NCT03512457|EG000|Reported Event|Intensive Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week by telephone call, text message or email to perform SSE.~Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure."
11333372|NCT03512457|EG001|Reported Event|Minimal Intervention|"Participants receive brochure, card advising how to make an appointment with dermatology.~Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure."
11319787|NCT03295201|FG000|Participant Flow|Pulmonary Rehabilitation+Exercise Group|"Active cycle of breathing techniques (ACBT) and postural exercise program~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.~Postural Exercise: Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks."
11319788|NCT03295201|FG001|Participant Flow|Pulmonary Rehabilitation Group|"Active cycle of breathing techniques (ACBT)~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks."
11319789|NCT03295201|OG000|Outcome|Pulmonary Rehabilitation+Exercise Group|"Active cycle of breathing techniques (ACBT) and postural exercise program~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.~Postural Exercise: Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks."
11319790|NCT03295201|OG001|Outcome|Pulmonary Rehabilitation Group|"Active cycle of breathing techniques (ACBT)~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks."
11319791|NCT03295201|EG000|Reported Event|Pulmonary Rehabilitation+Exercise Group|"Active cycle of breathing techniques (ACBT) and postural exercise program~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.~Postural Exercise: Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks."
11319792|NCT03295201|EG001|Reported Event|Pulmonary Rehabilitation Group|"Active cycle of breathing techniques (ACBT)~Active cycle of breathing techniques (ACBT): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks."
11319793|NCT03295266|BG000|Baseline|Moderate Hepatic Impairment (Panel A)|Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319794|NCT03295266|BG001|Baseline|Severe Hepatic Impairment (Panel B)|Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319795|NCT03295266|BG002|Baseline|Total|Total of all reporting groups
11319796|NCT03295266|FG000|Participant Flow|Moderate Hepatic Impairment (Panel A)|Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319797|NCT03295266|FG001|Participant Flow|Severe Hepatic Impairment (Panel B)|Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319798|NCT03295266|OG000|Outcome|Moderate Hepatic Impairment (Panel A)|Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319799|NCT03295266|OG001|Outcome|Severe Hepatic Impairment (Panel B)|Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319800|NCT03295266|EG000|Reported Event|Moderate Hepatic Impairment (Panel A)|Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319801|NCT03295266|EG001|Reported Event|Severe Hepatic Impairment (Panel B)|Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
11319802|NCT03295318|BG000|Baseline|Non-adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319803|NCT03295318|BG001|Baseline|Adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319804|NCT03295318|BG002|Baseline|Menactra|"Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319805|NCT03295318|BG003|Baseline|Total|Total of all reporting groups
11333373|NCT03513588|BG000|Baseline|Placebo|Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.
11333374|NCT03513588|BG001|Baseline|PF-06865571 50 mg|Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.
11333375|NCT03513588|BG002|Baseline|PF-06865571 300 mg|Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
11333376|NCT03513588|BG003|Baseline|Total|Total of all reporting groups
11319806|NCT03295318|FG000|Participant Flow|Non-adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319807|NCT03295318|FG001|Participant Flow|Adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319808|NCT03295318|FG002|Participant Flow|Menactra|"Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319809|NCT03295318|OG000|Outcome|Adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319810|NCT03295318|OG001|Outcome|Non-adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319811|NCT03295318|OG002|Outcome|Menactra|"Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319812|NCT03295318|OG000|Outcome|Non-adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319813|NCT03295318|OG001|Outcome|Adjuvanted Study Formulation NmCV-5|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319814|NCT03295318|OG002|Outcome|Menactra|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319815|NCT03295318|OG000|Outcome|Non-adjuvanted NmCV-5 (Days 0-6)|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
10827783|NCT00111813|EG003|Reported Event|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
10827784|NCT00111813|EG004|Reported Event|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
10827785|NCT00111813|EG005|Reported Event|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
10827786|NCT00111839|BG000|Baseline|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
10827787|NCT00111839|BG001|Baseline|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827788|NCT00111839|BG002|Baseline|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827789|NCT00111839|BG003|Baseline|Total|Total of all reporting groups
10827790|NCT00111839|FG000|Participant Flow|Pemetrexed Alone|Participants received pemetrexed 50 milligrams per square meter (mg/m^2) intravenous (IV) infusion every 3 weeks until disease progression (PD) or the occurrence of unacceptable toxicity.
10827791|NCT00111839|FG001|Participant Flow|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827792|NCT00111839|FG002|Participant Flow|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827793|NCT00111839|OG000|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
10827794|NCT00111839|OG001|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827795|NCT00111839|OG002|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827796|NCT00111839|EG000|Reported Event|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
10827797|NCT00111839|EG001|Reported Event|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
11333377|NCT03513588|FG000|Participant Flow|Placebo|Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.
11333378|NCT03513588|FG001|Participant Flow|PF-06865571 50 mg|Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.
10827798|NCT00111839|EG002|Reported Event|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
10827799|NCT00111917|BG000|Baseline|Infliximab|patients who will be placed on infliximab and controls who will get placebo
10827800|NCT00111917|BG001|Baseline|Control|CBD placed on placebo
10827801|NCT00111917|BG002|Baseline|Total|Total of all reporting groups
10827802|NCT00111917|FG000|Participant Flow|Group 1 - Infliximab|This group was given an infusion of inliximab
10827803|NCT00111917|FG001|Participant Flow|Group 2 - Placebo|This group was given a placebo infusion
10827804|NCT00111917|OG000|Outcome|Infliximab|Infliximab infusion
10827805|NCT00111917|OG001|Outcome|Placebo|Placebo infusion
10827806|NCT00111917|OG000|Outcome|Infliximab|Infliximab received
10827807|NCT00111917|OG001|Outcome|Placebo|Placebo received
10827808|NCT00111917|OG000|Outcome|Group 1|Infliximab
10827809|NCT00111917|OG001|Outcome|Group 2|Placebo received
10827810|NCT00111917|EG000|Reported Event|Group 1 - Infliximab|Infliximab infusion received
10827811|NCT00111917|EG001|Reported Event|Group 2 - Placebo|Placebo infusion received
10827812|NCT00112047|BG000|Baseline|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
11333379|NCT03513588|FG002|Participant Flow|PF-06865571 300 mg|Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
11333380|NCT03513588|OG000|Outcome|Placebo|Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.
11319816|NCT03295318|OG001|Outcome|Adjuvanted NmCV-5 (Days 0-6)|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319817|NCT03295318|OG002|Outcome|Menactra (Days 0-6)|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319818|NCT03295318|OG003|Outcome|Non-adjuvanted NmCV-5 (Days 84-90)|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319819|NCT03295318|OG004|Outcome|Adjuvanted NmCV-5 (Days 84-90)|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319820|NCT03295318|OG005|Outcome|Menactra (Days 84-90)|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319821|NCT03295318|OG000|Outcome|Non-adjuvanted NmCV-5 (Days 0-27)|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319822|NCT03295318|OG001|Outcome|Adjuvanted NmCV-5 (Days 0-27)|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319823|NCT03295318|OG002|Outcome|Menactra (Days 0-27)|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319824|NCT03295318|OG003|Outcome|Non-adjuvanted NmCV-5 (Days 84-111)|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319825|NCT03295318|OG004|Outcome|Adjuvanted NmCV-5 (Days 84-111)|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319826|NCT03295318|OG005|Outcome|Menactra (Days 84-111)|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.~Menactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319827|NCT03295318|EG000|Reported Event|Non-adjuvanted NmCV-5 Dose 1|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~First dose to be administered is 0.5 mL intramuscularly.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319828|NCT03295318|EG001|Reported Event|Adjuvanted NmCV-5 Dose 1|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~First dose to be administered is 0.5 mL intramuscularly.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319829|NCT03295318|EG002|Reported Event|Menactra Dose 1|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319830|NCT03295318|EG003|Reported Event|Non-adjuvanted NmCV-5 Dose 2|"Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1.~Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine."
11319831|NCT03295318|EG004|Reported Event|Adjuvanted NmCV-5 Dose 2|"Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.~Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1.~Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine"
11319832|NCT03295318|EG005|Reported Event|Menactra Dose 2|"Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.~Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1.~Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine."
11319833|NCT03295630|BG000|Baseline|Accelerometer|"Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg~Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count"
11319834|NCT03295630|FG000|Participant Flow|Accelerometer (Single Group Recruited)|"Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg~Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count"
11319835|NCT03295630|OG000|Outcome|Accelerometer|"Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg~Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count"
11319836|NCT03295630|OG000|Outcome|Accelerometer|Participants rating of accelerometer comfort using a 5-point Likert Scale
11319837|NCT03295630|EG000|Reported Event|Accelerometer (Single Group Recruited)|"Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg~Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count"
11319838|NCT03295721|BG000|Baseline|Treatment Group 1: HTX-011|HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.
11319839|NCT03295721|BG001|Baseline|Treatment Group 2: Saline Placebo|Saline placebo by instillation.
11319840|NCT03295721|BG002|Baseline|Treatment Group 3: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 50 mg by injection.
11319841|NCT03295721|BG003|Baseline|Total|Total of all reporting groups
11319842|NCT03295721|FG000|Participant Flow|Treatment Group 1: HTX-011|HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.
11319843|NCT03295721|FG001|Participant Flow|Treatment Group 2: Saline Placebo|Saline placebo by instillation.
11319844|NCT03295721|FG002|Participant Flow|Treatment Group 3: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 50 mg by injection.
11319845|NCT03295721|OG000|Outcome|Treatment Group 1: HTX-011|HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.
11319846|NCT03295721|OG001|Outcome|Treatment Group 2: Saline Placebo|Saline placebo by instillation.
11319847|NCT03295721|OG001|Outcome|Treatment Group 3: Bupivacaine HCI|Bupivacaine HCl without epinephrine, 50 mg by injection.
11319848|NCT03295721|OG001|Outcome|Treatment Group 3: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg by injection.
11319849|NCT03295721|EG000|Reported Event|Treatment Group 1: HTX-011|HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.
11319850|NCT03295721|EG001|Reported Event|Treatment Group 2: Saline Placebo|"Saline placebo by instillation.~1 subject was randomized to bupivacaine HCl, but received saline placebo. (Ie, ITT = 100 and Safety population = 101)."
11319851|NCT03295721|EG002|Reported Event|Treatment Group 3: Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg by injection.
11319852|NCT03296072|BG000|Baseline|Overall Participants|All randomized participants were included for baseline evaluation. Participants applied a full ribbon of the test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3), comparator (0.454% w/w SnF2[1100 ppm fluoride]) and placebo product (5% KNO3 [0 ppm fluoride]) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, participants gently rinsed with 15 mL of tap water for 10 seconds before expectorating again.
11319853|NCT03296072|FG000|Participant Flow|Test Product/Comparator Product/Placebo Product|Participants in this arm received test product (0.254% weight by weight [w/w] sodium fluoride [NaF; 1150 parts per million {ppm} fluoride] and 5% potassium nitrate [KNO3]) followed by comparator (0.454% w/w stannous fluoride [SnF2; 1100 ppm fluoride]) and placebo product (5% KNO3 [0 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 grams [g]) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing,for a timed period of 95 seconds. After expectorating the slurry, participants gently rinsed their mouths with 15 milliliters [mL] of tap water for 10 seconds before expectorating again.
11319854|NCT03296072|FG001|Participant Flow|Test Product/Placebo Product/Comparator Product|Participants in this arm received test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) followed by placebo (5% KNO3 [0 ppm fluoride])and comparator product (0.454% w/w SnF2[1100 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
11319855|NCT03296072|FG002|Participant Flow|Comparator Product/Test Product/Placebo Product|Participants in this arm received comparator product (0.454% w/w SnF2[1100 ppm fluoride]) followed by test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) and placebo product(5% KNO3 [0 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
11319856|NCT03296072|FG003|Participant Flow|Comparator Product/Placebo Product/ Test Product|Participants in this arm received comparator product (0.454% w/w SnF2[1100 ppm fluoride]) followed by placebo (5% KNO3 [0 ppm fluoride])and test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
11319857|NCT03296072|FG004|Participant Flow|Placebo Product/Test Product/Comparator Product|Participants in this arm received placebo product (5% KNO3 [0 ppm fluoride]) followed by test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) and comparator product (0.454% w/w SnF2 [1100 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
11319858|NCT03296072|FG005|Participant Flow|Placebo Product/Comparator Product/Test Product|Participants in this arm received placebo product (5% KNO3 [0 ppm fluoride]) followed by comparator (0.454% w/w SnF2[1100 ppm fluoride]) and test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
10848566|NCT00290472|FG002|Participant Flow|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
11319859|NCT03296072|OG000|Outcome|Test Product|Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11319860|NCT03296072|OG001|Outcome|Placebo Product|Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11333381|NCT03513588|OG001|Outcome|PF-06865571 50 mg|Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.
11333382|NCT03513588|OG002|Outcome|PF-06865571 300 mg|Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
10848567|NCT00290472|OG000|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
11319861|NCT03296072|OG001|Outcome|Comparator Product|Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11319862|NCT03296072|EG000|Reported Event|Test Product|Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11319863|NCT03296072|EG001|Reported Event|Comparator Product|Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11319864|NCT03296072|EG002|Reported Event|Placebo Product|Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
11319865|NCT03296163|BG000|Baseline|MB02 (Bevacizumab Biosimilar Drug)|"MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel~MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319866|NCT03296163|BG001|Baseline|EU-approved Avastin®|"EU-approved Avastin® + Carboplatin/Paclitaxel~EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319867|NCT03296163|BG002|Baseline|Total|Total of all reporting groups
11319868|NCT03296163|FG000|Participant Flow|MB02 (Bevacizumab Biosimilar Drug)|"MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel~MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319869|NCT03296163|FG001|Participant Flow|EU-approved Avastin®|"EU-approved Avastin® + Carboplatin/Paclitaxel~EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319870|NCT03296163|OG000|Outcome|MB02 (Bevacizumab Biosimilar Drug)|"MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel~MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319871|NCT03296163|OG001|Outcome|EU-approved Avastin®|"EU-approved Avastin® + Carboplatin/Paclitaxel~EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319872|NCT03296163|EG000|Reported Event|MB02 (Bevacizumab Biosimilar Drug)|"MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel~MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319873|NCT03296163|EG001|Reported Event|EU-approved Avastin®|"EU-approved Avastin® + Carboplatin/Paclitaxel~EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1~Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles~Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles"
11319874|NCT03296280|BG000|Baseline|Early Intervention|This cohort of 10 facilities will undergo early training by participating in the first 6 POCUS course sessions during FY17
11319875|NCT03296280|BG001|Baseline|Late Intervention|This cohort of 10 facilities will undergo late training by participating in the last 6 POCUS courses during FY17.
11319876|NCT03296280|BG002|Baseline|Total|Total of all reporting groups
11319877|NCT03296280|FG000|Participant Flow|Early Intervention|This cohort of 10 facilities will undergo early training by participating in the first 6 POCUS course sessions during FY17. Although facilities are being recruited the intervention is taking place at the individual level. All reporting will be at the individual level.
11319878|NCT03296280|FG001|Participant Flow|Late Intervention|This cohort of 10 facilities will undergo late training by participating in the last 6 POCUS courses during FY17. Although facilities are being recruited the intervention is taking place at the individual level. All reporting will be at the individual level.
11319879|NCT03296280|OG000|Outcome|Early Intervention|This cohort of 10 facilities will undergo early training by participating in the first 6 POCUS course sessions during FY17
11319880|NCT03296280|OG001|Outcome|Late Intervention|This cohort of 10 facilities will undergo late training by participating in the last 6 POCUS courses during FY17.
11319881|NCT03296280|EG000|Reported Event|Early Intervention|This cohort of 10 facilities will undergo early training by participating in the first 6 POCUS course sessions during FY17
11319882|NCT03296280|EG001|Reported Event|Late Intervention|This cohort of 10 facilities will undergo late training by participating in the last 6 POCUS courses during FY17.
11319883|NCT03296345|BG000|Baseline|Study Participants|"Intervention: Prior to the second dose of IV opiates, the experiment was to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg.~Ketamine: The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs)."
11333383|NCT03513588|OG000|Outcome|PF-06865571 50 mg|Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.
11333384|NCT03513588|OG001|Outcome|PF-06865571 300 mg|Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
11333385|NCT03513588|EG000|Reported Event|Placebo|Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.
11333386|NCT03513588|EG001|Reported Event|PF-06865571 50 mg|Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.
11319884|NCT03296345|FG000|Participant Flow|Study Participants|"Intervention: Prior to the second dose of IV opiates, the experiment was to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg.~Ketamine: The intervention was IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).~Ultimately, 62 patient encounters were enrolled in the study.~Historical Control: Patient data from at least one but up three patient encounters within the prior year were compared to their visit in which they were given adjuvant ketamine, using the outcome measures in the Intervention arm. Since this a historical control study, patients acted as their own controls in the above manner. Patients were allowed to re-enroll 4 weeks after presentation, which is typically considered a separate vaso-occlusive episode in the literature."
11319885|NCT03296345|OG000|Outcome|Intervention|"Prior to the second dose of IV opiates, the experiment was to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg.~Ketamine: The intervention was IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).~Ultimately, 62 patient encounters were enrolled in the study."
11319886|NCT03296345|OG001|Outcome|Historical Control|"Patient data from at least one but up three patient encounters within the prior year were compared to their visit in which they were given adjuvant ketamine, using the outcome measures in the Intervention arm. Since this a historical control study, patients acted as their own controls in the above manner. Patients were allowed to re-enroll 4 weeks after presentation, which is typically considered a separate vaso-occlusive episode in the literature."
11319887|NCT03296345|OG001|Outcome|Historical Control|"Patient data from at least one but up three patient encounters within the prior year were compared to their visit in which they were given adjuvant ketamine, using the outcome measures in the Intervention arm. Since this a historical control study, patients acted as their own controls in the above manner."
11319888|NCT03296345|EG000|Reported Event|Intervention|"Prior to the second dose of IV opiates, the experiment was to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg.~Ketamine: The intervention was IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).~Ultimately, 62 patient encounters were enrolled in the study."
11319889|NCT03296527|BG000|Baseline|FE 000049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319890|NCT03296527|BG001|Baseline|GONAL-F (Follitropin Alfa)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319891|NCT03296527|BG002|Baseline|Total|Total of all reporting groups
11319892|NCT03296527|FG000|Participant Flow|FE 000049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319893|NCT03296527|FG001|Participant Flow|GONAL-F (Follitropin Alfa)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days
11319894|NCT03296527|OG000|Outcome|FE 000049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319895|NCT03296527|OG001|Outcome|GONAL-F (Follitropin Alfa)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319896|NCT03296527|OG001|Outcome|GONAL-F (Follitropin Alfa)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days
11333387|NCT03513588|EG002|Reported Event|PF-06865571 300 mg|Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
11319897|NCT03296527|EG000|Reported Event|FE 000049 (Follitropin Delta)|FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319898|NCT03296527|EG001|Reported Event|GONAL-F (Follitropin Alfa)|GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days.
11319899|NCT03296566|BG000|Baseline|Patient Liaison Intervention|"The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.~Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist."
11319900|NCT03296566|BG001|Baseline|Control|The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
11319901|NCT03296566|BG002|Baseline|Total|Total of all reporting groups
11319902|NCT03296566|FG000|Participant Flow|Patient Liaison Intervention|"The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.~Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist."
11319903|NCT03296566|FG001|Participant Flow|Control|The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
11319904|NCT03296566|OG000|Outcome|Patient Liaison Intervention|"The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.~Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist."
11319905|NCT03296566|OG001|Outcome|Control|The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
11319906|NCT03296566|EG000|Reported Event|Patient Liaison Intervention|"The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.~Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist."
11319907|NCT03296566|EG001|Reported Event|Control|The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
11319908|NCT03296787|BG000|Baseline|Group A: Healthy Participants|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 milligram per kilogram [mg/kg], intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
11319909|NCT03296787|BG001|Baseline|Group C: Moderate Renal Impairment|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 mg/kg, intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
11319910|NCT03296787|BG002|Baseline|Group D: Severe Renal Impairment Not Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
11319911|NCT03296787|BG003|Baseline|Group E: ESRD Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1, followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
11319912|NCT03296787|BG004|Baseline|Total|Total of all reporting groups
11319913|NCT03296787|FG000|Participant Flow|Group A: Healthy Participants|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 milligram per kilogram [mg/kg], intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
11319914|NCT03296787|FG001|Participant Flow|Group C: Moderate Renal Impairment|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 mg/kg, intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
11319915|NCT03296787|FG002|Participant Flow|Group D: Severe Renal Impairment Not Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
11319916|NCT03296787|FG003|Participant Flow|Group E: ESRD Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1, followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
11319917|NCT03296787|OG000|Outcome|Group A: Healthy Participants|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 milligram per kilogram [mg/kg], intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
11319918|NCT03296787|OG001|Outcome|Group C: Moderate Renal Impairment|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 mg/kg, intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
11319919|NCT03296787|OG002|Outcome|Group D: Severe Renal Impairment Not Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
11319920|NCT03296787|OG000|Outcome|Group E: ESRD Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1, followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
11319921|NCT03296787|EG000|Reported Event|Group A: Healthy Participants|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 milligram per kilogram [mg/kg], intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
10827813|NCT00112047|BG001|Baseline|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
11319922|NCT03296787|EG001|Reported Event|Group C: Moderate Renal Impairment|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral [CYP1A2] + midazolam 0.025 mg/kg, intravenously [CYP3A4]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
11319923|NCT03296787|EG002|Reported Event|Group D: Severe Renal Impairment Not Requiring Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
11319924|NCT03296787|EG003|Reported Event|Group E: ESRD 1 Hour After Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1 in participants with ESRD requiring dialysis.
11319925|NCT03296787|EG004|Reported Event|Group E: ESRD 2 Hours Before Dialysis|TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
11319926|NCT03296800|BG000|Baseline|Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319927|NCT03296800|BG001|Baseline|Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
11319928|NCT03296800|BG002|Baseline|Bexagliflozin, Then Verapamil and Bexagliflozin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
10827814|NCT00112047|BG002|Baseline|Total|Total of all reporting groups
11319929|NCT03296800|BG003|Baseline|Total|Total of all reporting groups
11319930|NCT03296800|FG000|Participant Flow|Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid|Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg, bid.
11319931|NCT03296800|FG001|Participant Flow|Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin|Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.
11319932|NCT03296800|FG002|Participant Flow|Bexagliflozin, Then Verapamil and Bexagliflozin|Subjects were dosed with bexagliflozin tablets, 20 mg, and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a bexagliflozin tablet.
11319933|NCT03296800|OG000|Outcome|Study 1: Bexagliflozin Alone|Bexagliflozin tablets, 20 mg; qd
11319934|NCT03296800|OG001|Outcome|Study 1: Bexagliflozin and Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319935|NCT03296800|OG002|Outcome|Study 2: Bexagliflozin Alone|Bexagliflozin tablets, 20 mg; qd
11319936|NCT03296800|OG003|Outcome|Study 2: Bexagliflozin and Rifampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
11319937|NCT03296800|OG004|Outcome|Study 3: Bexagliflozin Alone|Bexagliflozin tablets, 20 mg; qd
11319938|NCT03296800|OG005|Outcome|Study 3: Bexagliflozin and Verapamil|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
11319939|NCT03296800|OG000|Outcome|Bexagliflozin/Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319940|NCT03296800|OG001|Outcome|Bexagliflozin/Rifampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
11319941|NCT03296800|OG002|Outcome|Bexagliflozin/Verapamil|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
11319942|NCT03296800|OG001|Outcome|Study 1: Bexagliflozin/Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319943|NCT03296800|OG003|Outcome|Study 2: Bexagliflozin/Rifampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
10843000|NCT00251303|EG000|Reported Event|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
11319944|NCT03296800|OG005|Outcome|Study 3: Bexagliflozin/Verapamil|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
11319945|NCT03296800|OG001|Outcome|Bexagliflozin/Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319946|NCT03296800|OG003|Outcome|Bexagliflozin/Rifampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
11319947|NCT03296800|OG005|Outcome|Bexagliflozin/Verapamil|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
11319948|NCT03296800|EG000|Reported Event|Study 1: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
11319949|NCT03296800|EG001|Reported Event|Study 1: Bexagliflozin and Probenecid|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Probenecid: Probenecid tablets, 500 mg; bid"
11319950|NCT03296800|EG002|Reported Event|Study 2: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
11319951|NCT03296800|EG003|Reported Event|Study 2: Bexagliflozin and Rrifampin|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd"
11319952|NCT03296800|EG004|Reported Event|Study 3: Bexagliflozin Alone|Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
11319953|NCT03296800|EG005|Reported Event|Study 3: Bexagliflozin and Verapamil|"Bexagliflozin: Bexagliflozin tablets, 20 mg; qd~Verapamil: Verapamil hydrochloride tablets, 120 mg; qd"
11319954|NCT03297021|BG000|Baseline|Ondansetron 4mg Pre-emergence|Ondansetron 4 MG Pre-emergence
11319955|NCT03297021|BG001|Baseline|Ondansetron 8mg Pre-emergence|Ondansetron 8mg Pre-emergence
11319956|NCT03297021|BG002|Baseline|Ondansetron Pre-Incision and Pre-emergence|4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
11319957|NCT03297021|BG003|Baseline|Total|Total of all reporting groups
11319958|NCT03297021|FG000|Participant Flow|Ondansetron 4mg Pre-emergence|Ondansetron 4 MG Pre-emergence
11319959|NCT03297021|FG001|Participant Flow|Ondansetron 8mg Pre-emergence|Ondansetron 8mg Pre-emergence
11319960|NCT03297021|FG002|Participant Flow|Ondansetron Pre-Incision and Pre-emergence|4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
11319961|NCT03297021|OG000|Outcome|Ondansetron 4mg Pre-emergence|Ondansetron 4 MG Pre-emergence
11319962|NCT03297021|OG001|Outcome|Ondansetron 8mg Pre-emergence|Ondansetron 8mg Pre-emergence
11319963|NCT03297021|OG002|Outcome|Ondansetron Pre-Incision and Pre-emergence|4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
11319964|NCT03297021|EG000|Reported Event|Ondansetron 4mg Pre-emergence|Ondansetron 4 MG Pre-emergence
11319965|NCT03297021|EG001|Reported Event|Ondansetron 8mg Pre-emergence|Ondansetron 8mg Pre-emergence
11319966|NCT03297021|EG002|Reported Event|Ondansetron Pre-Incision and Pre-emergence|4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
11319967|NCT03297112|BG000|Baseline|Contrast-enhanced Subharmonic Ultrasound Imaging|"Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.~Perflutren Lipid Microspheres: Given IV~Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging"
11319968|NCT03297112|FG000|Participant Flow|Contrast-enhanced Subharmonic Ultrasound Imaging|"Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.~Perflutren Lipid Microspheres: Given IV~Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging"
11319969|NCT03297112|OG000|Outcome|Contrast-enhanced Subharmonic Ultrasound Imaging|"Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.~Perflutren Lipid Microspheres: Given IV~Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging"
11319970|NCT03297112|EG000|Reported Event|Contrast-enhanced Subharmonic Ultrasound Imaging|"Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.~Perflutren Lipid Microspheres: Given IV~Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging"
11319971|NCT03297216|BG000|Baseline|Mothers: 250 mg 17P|"Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~17P: Synthetic progestin"
11319972|NCT03297216|BG001|Baseline|Mothers: Placebo|"Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319973|NCT03297216|BG002|Baseline|Total|Total of all reporting groups
11319974|NCT03297216|FG000|Participant Flow|250 mg 17P|"The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~17P: Synthetic progestin"
11319975|NCT03297216|FG001|Participant Flow|Placebo|"The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319976|NCT03297216|OG000|Outcome|250 mg 17P|"The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~17P: Synthetic progestin"
11319977|NCT03297216|OG001|Outcome|Placebo|"The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319978|NCT03297216|OG001|Outcome|Placebo|"The study intervention started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319979|NCT03297216|OG000|Outcome|250mg 17P|"Infant born to mother receiving weekly intramuscular injection of 250mg 17P~17P: Synthetic progestin"
11319980|NCT03297216|OG001|Outcome|Placebo|"Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo~Placebo: Non-active placebo comparator"
11319981|NCT03297216|OG000|Outcome|250 mg 17P|Infant born to mother receiving weekly intramuscular injection of 250mg 17P 17P: Synthetic progestin
11319982|NCT03297216|OG001|Outcome|Placebo|Infant born to mother receiving weekly intramuscular injection of indistinguishable placebo Placebo: Non-active placebo comparator
11319983|NCT03297216|EG000|Reported Event|Mothers: 250 mg 17P|"Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~17P: Synthetic progestin"
11319984|NCT03297216|EG001|Reported Event|Mothers: Placebo|"Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319985|NCT03297216|EG002|Reported Event|Infants Born to Mothers Receiving 250 mg 17P|"Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~17P: Synthetic progestin"
11319986|NCT03297216|EG003|Reported Event|Infants Born to Mothers Receiving Placebo|"Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.~Placebo: Non-active placebo comparator"
11319987|NCT03297294|BG000|Baseline|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
10843001|NCT00251303|EG001|Reported Event|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
11319988|NCT03297294|BG001|Baseline|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11319989|NCT03297294|BG002|Baseline|Total|Total of all reporting groups
11319990|NCT03297294|FG000|Participant Flow|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11319991|NCT03297294|FG001|Participant Flow|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11319992|NCT03297294|FG002|Participant Flow|EMA401 100mg BID -> EMA401 100mg BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11319993|NCT03297294|FG003|Participant Flow|EMA401 100mg BID -> Placebo BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11319994|NCT03297294|FG004|Participant Flow|Placebo BID -> Placebo BID TW|Participants on placebo remained on placebo at end of DB treatment period (week 12)
11319995|NCT03297294|OG000|Outcome|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11319996|NCT03297294|OG001|Outcome|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11319997|NCT03297294|OG000|Outcome|EMA401 100mg BID -> EMA401 100mg BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11319998|NCT03297294|OG001|Outcome|EMA401 100mg BID -> Placebo BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11319999|NCT03297294|OG002|Outcome|Placebo BID -> Placebo BID TW|Participants on placebo remained on placebo at end of DB treatment period (week 12)
11320000|NCT03297294|EG000|Reported Event|EMA401 100mg BID DB|Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
11320001|NCT03297294|EG001|Reported Event|Placebo BID DB|Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
11320002|NCT03297294|EG002|Reported Event|EMA401 100mg BID -> EMA401 100mg BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11320003|NCT03297294|EG003|Reported Event|EMA401 100mg BID -> Placebo BID TW|Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of DB treatment period (week 12)
11320004|NCT03297294|EG004|Reported Event|Placebo BID -> Placebo BID TW|Participants on placebo remained on placebo at end of DB treatment period (week 12)
11320005|NCT03297398|BG000|Baseline|Other|"Placebo Group~Placebo: Placebo"
11320006|NCT03297398|BG001|Baseline|Drug Group 1|"15mg, OPK-88004~Group-1 (15mg, OPK-88004): 15mg, OPK-88004"
11320007|NCT03297398|BG002|Baseline|Drug Group 2|"25,mg OPK-88004~Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004"
11320008|NCT03297398|BG003|Baseline|Total|Total of all reporting groups
11320009|NCT03297398|FG000|Participant Flow|Placebo|"Placebo Group~Placebo: Placebo"
11320010|NCT03297398|FG001|Participant Flow|OPK-88004 15 mg|"15mg, OPK-88004~Group-1 (15mg, OPK-88004): 15mg, OPK-88004"
11320011|NCT03297398|FG002|Participant Flow|OPK-88004 25 mg|"25mg, OPK-88004~Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004"
11320012|NCT03297398|OG000|Outcome|Other|"Placebo Group~Placebo: Placebo"
11320013|NCT03297398|OG001|Outcome|Drug Group 1|"15mg, OPK-88004~Group-1 (15mg, OPK-88004): 15mg, OPK-88004"
11320014|NCT03297398|OG002|Outcome|Drug Group 2|"25,mg OPK-88004~Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004"
11320015|NCT03297398|EG000|Reported Event|Other|"Placebo Group~Placebo: Placebo"
11320016|NCT03297398|EG001|Reported Event|Drug Group 1|"15mg, OPK-88004~Group-1 (15mg, OPK-88004): 15mg, OPK-88004"
11320017|NCT03297398|EG002|Reported Event|Drug Group 2|"25,mg OPK-88004~Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004"
11320018|NCT03297944|BG000|Baseline|All Participants|All 15 participants received each intervention.
11320019|NCT03297944|FG000|Participant Flow|All Participants|All participants received all six interventions; combinations of placebo (PLC), alprazolam (ALP) or zolpidem (ZOL).
11320020|NCT03297944|OG000|Outcome|All Participants|All participants received all 6 interventions.
11320021|NCT03297944|EG000|Reported Event|2ALP/PLC|"2mg Alprazolam administered at night, placebo administered in the morning~Alprazolam: 0.5 to 2mg administered at night or in the morning"
11320022|NCT03297944|EG001|Reported Event|1ALP/PLC|"1mg Alprazolam administered at night, placebo administered in the morning~Alprazolam: 0.5 to 2mg administered at night or in the morning"
11320023|NCT03297944|EG002|Reported Event|0.5ALP/PLC|"0.5mg Alprazolam administered at night, placebo administered in the morning~Alprazolam: 0.5 to 2mg administered at night or in the morning"
11320024|NCT03297944|EG003|Reported Event|ZOL/PLC|"10mg Zolpidem administered at night, placebo administered in the morning~Zolpidem: 10mg administered at night or in the morning"
11320025|NCT03297944|EG004|Reported Event|PLC/PLC|"Placebo administered at night, placebo administered in the morning~Placebo: placebo administered at night and/or in the morning"
11320026|NCT03297944|EG005|Reported Event|PLC/ALP|"Placebo administered at night, 1mg alprazolam administered in the morning~Alprazolam: 0.5 to 2mg administered at night or in the morning"
11320027|NCT03298035|BG000|Baseline|NIPPV as Rescue Mode for Apnea Prevention|"With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.~NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment."
11320028|NCT03298035|BG001|Baseline|NCPAP as Mode for Apnea Prevention|"With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.~NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment."
11320029|NCT03298035|BG002|Baseline|Total|Total of all reporting groups
11320030|NCT03298035|FG000|Participant Flow|NIPPV as Rescue Mode for Apnea Prevention|"With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.~NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment."
11320031|NCT03298035|FG001|Participant Flow|NCPAP as Mode for Apnea Prevention|"With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.~NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment."
11320032|NCT03298035|OG000|Outcome|NIPPV as Rescue Mode for Apnea Prevention|"With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.~NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment."
11320033|NCT03298035|OG001|Outcome|NCPAP as Mode for Apnea Prevention|"With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.~NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment."
11320034|NCT03298035|EG000|Reported Event|NIPPV as Rescue Mode for Apnea Prevention|"With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.~NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment."
11320035|NCT03298035|EG001|Reported Event|NCPAP as Mode for Apnea Prevention|"With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.~NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment."
11320036|NCT03298048|BG000|Baseline|Low Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days~Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days"
11320037|NCT03298048|BG001|Baseline|Mid Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment~Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment"
11320038|NCT03298048|BG002|Baseline|High Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days~High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days"
10843002|NCT00251316|BG000|Baseline|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
10843003|NCT00251316|BG001|Baseline|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
10843004|NCT00251316|BG002|Baseline|Total|Total of all reporting groups
11320039|NCT03298048|BG003|Baseline|Total|Total of all reporting groups
11320040|NCT03298048|FG000|Participant Flow|Low Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days~Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days"
11320041|NCT03298048|FG001|Participant Flow|Mid Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment~Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment"
11320042|NCT03298048|FG002|Participant Flow|High Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days~High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days"
11320043|NCT03298048|OG000|Outcome|Low Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days~Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days"
11320044|NCT03298048|OG001|Outcome|Mid Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment~Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment"
11320045|NCT03298048|OG002|Outcome|High Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days~High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days"
11320046|NCT03298048|EG000|Reported Event|Low Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days~Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days"
11320047|NCT03298048|EG001|Reported Event|Mid Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment~Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment"
11320048|NCT03298048|EG002|Reported Event|High Fecal Microbiota Dose|"receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days~High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days"
11320049|NCT03298113|BG000|Baseline|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.~Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier."
11320050|NCT03298113|BG001|Baseline|IAD Hospital Standard Care|"Marketed products are applied according to the IAD hospital standard care routine.~IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use."
11320051|NCT03298113|BG002|Baseline|Total|Total of all reporting groups
11320052|NCT03298113|FG000|Participant Flow|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.~Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier."
11320053|NCT03298113|FG001|Participant Flow|IAD Hospital Standard Care|"Marketed products are applied according to the IAD hospital standard care routine.~IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use."
11320054|NCT03298113|OG000|Outcome|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.~Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier."
11320055|NCT03298113|OG001|Outcome|IAD Hospital Standard Care|"Marketed products are applied according to the IAD hospital standard care routine.~IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use."
11320056|NCT03298113|EG000|Reported Event|Cavilon Advanced Skin Protectant|"Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.~Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier."
11320057|NCT03298113|EG001|Reported Event|IAD Hospital Standard Care|"Marketed products are applied according to the IAD hospital standard care routine.~IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use."
11320058|NCT03298412|BG000|Baseline|Blinatumomab|"After a run-in period of up to 24 months to evaluate MRD status and assess eligibility for treatment assignment, participants received blinatumomab intravenous (IV) infusion at an initial dose of 9 μg/day for the first 7 days of treatment, escalated (dose-step) to 28 μg/day starting on Day 8 (Week 2), followed by a dose-step to 112 μg/day starting on Day 15 (Week 3) and continuing until completion of therapy (Day 57 of Cycle 1).~Cycle 1 of blinatumomab treatment is 12 weeks (84 days) in duration and includes 8 weeks (56 days) of blinatumomab IV infusion followed by a 4-week (28-day) treatment-free interval."
10843005|NCT00251316|FG000|Participant Flow|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
11320059|NCT03298412|FG000|Participant Flow|Blinatumomab|"After a run-in period of up to 24 months to evaluate MRD status and assess eligibility for treatment assignment, participants received blinatumomab intravenous (IV) infusion at an initial dose of 9 μg/day for the first 7 days of treatment, escalated (dose-step) to 28 μg/day starting on Day 8 (Week 2), followed by a dose-step to 112 μg/day starting on Day 15 (Week 3) and continuing until completion of therapy (Day 57 of Cycle 1).~Cycle 1 of blinatumomab treatment is 12 weeks (84 days) in duration and includes 8 weeks (56 days) of blinatumomab IV infusion followed by a 4-week (28-day) treatment-free interval."
11320060|NCT03298412|OG000|Outcome|Blinatumomab|"After a run-in period of up to 24 months to evaluate MRD status and assess eligibility for treatment assignment, participants received blinatumomab intravenous (IV) infusion at an initial dose of 9 μg/day for the first 7 days of treatment, escalated (dose-step) to 28 μg/day starting on Day 8 (Week 2), followed by a dose-step to 112 μg/day starting on Day 15 (Week 3) and continuing until completion of therapy (Day 57 of Cycle 1).~Cycle 1 of blinatumomab treatment is 12 weeks (84 days) in duration and includes 8 weeks (56 days) of blinatumomab IV infusion followed by a 4-week (28-day) treatment-free interval."
11320061|NCT03298412|EG000|Reported Event|Blinatumomab|"After a run-in period of up to 24 months to evaluate MRD status and assess eligibility for treatment assignment, participants received blinatumomab intravenous (IV) infusion at an initial dose of 9 μg/day for the first 7 days of treatment, escalated (dose-step) to 28 μg/day starting on Day 8 (Week 2), followed by a dose-step to 112 μg/day starting on Day 15 (Week 3) and continuing until completion of therapy (Day 57 of Cycle 1).~Cycle 1 of blinatumomab treatment is 12 weeks (84 days) in duration and includes 8 weeks (56 days) of blinatumomab IV infusion followed by a 4-week (28-day) treatment-free interval."
11320062|NCT03298841|BG000|Baseline|Zeiss Group|patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software
11320063|NCT03298841|BG001|Baseline|Leica Stativ S3B|patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
11320064|NCT03298841|BG002|Baseline|Total|Total of all reporting groups
11320065|NCT03298841|FG000|Participant Flow|Zeiss Group|patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software
11320066|NCT03298841|FG001|Participant Flow|Leica Stativ S3B|patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
11320067|NCT03298841|OG000|Outcome|Zeiss Group|patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software
11320068|NCT03298841|OG001|Outcome|Leica Stativ S3B|patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
11320069|NCT03298841|OG000|Outcome|Cataract Surgery Patients|Patients undergoing immediate cataract surgery at a single site with one of two operating microscopes
11320070|NCT03298841|EG000|Reported Event|Zeiss Group|patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software
11320071|NCT03298841|EG001|Reported Event|Leica Stativ S3B|patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
11320072|NCT03298880|BG000|Baseline|Four VM's|"Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter~Supine VM VAD: Valsalva strain delivered using VAD~Supine VAD manometer: supine Valsalva strain delivered using manometer~Modified VM VAD: modified VM using VAD~Modified VM Manonmeter: Postural modified position VM using manometer"
11320073|NCT03298880|FG000|Participant Flow|Four VM's|"Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter~Supine VM VAD: Valsalva strain delivered using VAD~Supine VAD manometer: supine Valsalva strain delivered using manometer~Modified VM VAD: modified VM using VAD~Modified VM Manonmeter: Postural modified position VM using manometer"
11320074|NCT03298880|OG000|Outcome|Mean Drop in Heart Rate Using the Modified VM|This measures the mean drop in heart rate before and after the modified valsalva manoeuvre using both the VAD and monometer
11320075|NCT03298880|OG001|Outcome|Mean Drop in Heart Rate of Supine VM|This measures the mean drop in heart rate before and after the supine valsalva manouevre using the both the VAD and monometer
11320076|NCT03298880|OG002|Outcome|Mean Drop in Heart Rate Using VAD|This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the VAD
11320077|NCT03298880|OG003|Outcome|Mean Drop in Heart Rate From Using the Manometer|This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the manometer
11320078|NCT03298880|OG000|Outcome|% Who Achieved 15 Second Strain Using a VAD|percentage of participants utilising the Valsalva assist device to achieve a valsalva manoeuvre who achieved the full 15 second strain using the Valsalva assist device
11320079|NCT03298880|OG001|Outcome|% Who Achieved 15 Second Strain Using a Manometer|percentage of participants utilising the manometer to achieve a valsalva manoeuvre who achieved the full 15 second strain using the manometer
11320080|NCT03298880|OG000|Outcome|Peak Pressures Acheived by VAD|peak pressure acheived by VAD
11320081|NCT03298880|OG001|Outcome|Peak Pressures Acheived by Manometer|Peak pressures achieved by manometer
11320082|NCT03298880|EG000|Reported Event|Four VM's|"Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter~Supine VM VAD: Valsalva strain delivered using VAD~Supine VAD manometer: supine Valsalva strain delivered using manometer~Modified VM VAD: modified VM using VAD~Modified VM Manonmeter: Postural modified position VM using manometer"
11320083|NCT03299101|BG000|Baseline|Prehabilitation|"Prospective sample of patients anticipating cardiothoracic surgery.~Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation."
11320084|NCT03299101|FG000|Participant Flow|Prehabilitation|"Prospective sample of patients anticipating cardiothoracic surgery.~Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation."
11320085|NCT03299101|OG000|Outcome|Prehabilitation|"Prospective sample of patients anticipating cardiothoracic surgery.~Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation."
11320086|NCT03299101|EG000|Reported Event|Prehabilitation|"Prospective sample of patients anticipating cardiothoracic surgery.~Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation."
11320087|NCT03299244|BG000|Baseline|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320088|NCT03299244|BG001|Baseline|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320089|NCT03299244|BG002|Baseline|Total|Total of all reporting groups
11320090|NCT03299244|FG000|Participant Flow|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320091|NCT03299244|FG001|Participant Flow|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320092|NCT03299244|OG000|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320093|NCT03299244|OG001|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320094|NCT03299244|OG000|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
10827815|NCT00112047|FG000|Participant Flow|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
10843006|NCT00251316|FG001|Participant Flow|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
11320095|NCT03299244|EG000|Reported Event|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320096|NCT03299244|EG001|Reported Event|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
11320097|NCT03299686|BG000|Baseline|CJM112 300 mg|Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320098|NCT03299686|BG001|Baseline|Placebo|Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320099|NCT03299686|BG002|Baseline|Total|Total of all reporting groups
11320100|NCT03299686|FG000|Participant Flow|CJM112 300 mg|Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320101|NCT03299686|FG001|Participant Flow|Placebo|Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320102|NCT03299686|OG000|Outcome|CJM112 300 mg|Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320103|NCT03299686|OG001|Outcome|Placebo|Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320104|NCT03299686|EG000|Reported Event|CJM112 300 mg|Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320105|NCT03299686|EG001|Reported Event|Placebo|Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
11320106|NCT03299881|BG000|Baseline|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320107|NCT03299881|BG001|Baseline|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320108|NCT03299881|BG002|Baseline|Total|Total of all reporting groups
11320109|NCT03299881|FG000|Participant Flow|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320110|NCT03299881|FG001|Participant Flow|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320111|NCT03299881|OG000|Outcome|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320112|NCT03299881|OG001|Outcome|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320113|NCT03299881|EG000|Reported Event|Treatment|"The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.~Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320114|NCT03299881|EG001|Reported Event|Control|"Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.~Diet & Exercise: Subjects to be instructed on a healthy 1200 calorie diet."
11320115|NCT03300050|BG000|Baseline|Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.
11320116|NCT03300050|BG001|Baseline|Group 2: cH8/1N1 LAIV and cH5/1N1 IIV|Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320117|NCT03300050|BG002|Baseline|Group 3: Placebo|Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.
11320118|NCT03300050|BG003|Baseline|Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320119|NCT03300050|BG004|Baseline|Group 5: Placebo|Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.
11320120|NCT03300050|BG005|Baseline|Total|Total of all reporting groups
11320121|NCT03300050|FG000|Participant Flow|Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL chimeric H8/1N1 live-attenuated influenza virus vaccine (cH8/1N1 LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03 (Adjuvant System 03)-adjuvanted chimeric H5/1N1 inactivated influenza virus vaccine (cH5/1N1 IIV) administered as an intramuscular injection on Day 85.
11320122|NCT03300050|FG001|Participant Flow|Group 2: cH8/1N1 LAIV and cH5/1N1 IIV|Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320123|NCT03300050|FG002|Participant Flow|Group 3: Placebo|Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.
11320124|NCT03300050|FG003|Participant Flow|Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL AS03-adjuvanted chimeric H8/1N1 inactivated influenza vaccine (cH8/1N1 IIV) administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320125|NCT03300050|FG004|Participant Flow|Group 5: Placebo|Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.
11320126|NCT03300050|OG000|Outcome|Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.
11320127|NCT03300050|OG001|Outcome|Group 2: cH8/1N1 LAIV and cH5/1N1 IIV|Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320128|NCT03300050|OG002|Outcome|Group 3: Placebo|Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.
11320129|NCT03300050|OG003|Outcome|Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320130|NCT03300050|OG004|Outcome|Group 5: Placebo|Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.
11320131|NCT03300050|EG000|Reported Event|Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.
11320132|NCT03300050|EG001|Reported Event|Group 2: cH8/1N1 LAIV and cH5/1N1 IIV|Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320133|NCT03300050|EG002|Reported Event|Group 3: Placebo|Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.
11320134|NCT03300050|EG003|Reported Event|Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant|Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
11320135|NCT03300050|EG004|Reported Event|Group 5: Placebo|Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.
11320136|NCT03300466|BG000|Baseline|GP0045 in Right NLF and Comparator in Left NLF|"Treatment with GP0045 in right NLF and comparator in left NLF~GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel"
11320137|NCT03300466|BG001|Baseline|Comparator in Right NLF and GP0045 in Left NLF|"Treatment with comparator in right NLF and GP0045 in left NLF~GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel"
11320138|NCT03300466|BG002|Baseline|Total|Total of all reporting groups
11320139|NCT03300466|FG000|Participant Flow|GP0045 in Right NLF and Comparator in Left NLF|"Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF~GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel"
11320140|NCT03300466|FG001|Participant Flow|Comparator in Right NLF and GP0045 in Left NLF|"Treatment with comparator in right NLF and GP0045 in left NLF~GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel"
11320141|NCT03300466|OG000|Outcome|GP0045|"Treatment with GP0045~GP0045: Hyaluronic acid gel"
11320142|NCT03300466|OG001|Outcome|Comparator|"Treatment with comparator~Comparator: Hyaluronic acid gel"
11320143|NCT03300466|EG000|Reported Event|GP0045 in Right NLF and Comparator in Left NLF|Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF
11320144|NCT03300466|EG001|Reported Event|Comparator in Right NLF and GP0045 in Left NLF|Treatment with comparator in right NLF and GP0045 in left NLF
11320145|NCT03300570|BG000|Baseline|Arm A (Placebo)|Participants receive placebo PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with placebo.
11320146|NCT03300570|BG001|Baseline|Arm B (Dolcanatide)|Participants receive dolcanatide PO QD for 7 days.All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with dolcanatide.
11320147|NCT03300570|BG002|Baseline|Total|Total of all reporting groups
11320148|NCT03300570|FG000|Participant Flow|Arm A (Placebo)|Participants receive placebo PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with placebo.
11320149|NCT03300570|FG001|Participant Flow|Arm B (Dolcanatide)|Participants receive dolcanatide PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with dolcanatide.
11320150|NCT03300570|OG000|Outcome|Arm B (Dolcanatide)|Participants receive dolcanatide PO QD for 7 days.All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with dolcanatide.
11320151|NCT03300570|OG001|Outcome|Arm A (Placebo)|Participants receive placebo PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with placebo.
11320152|NCT03300570|OG000|Outcome|Arm B (Dolcanatide)|Participants receive dolcanatide PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with dolcanatide.
11320153|NCT03300570|EG000|Reported Event|Arm A (Placebo)|Participants receive placebo PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing withplacebo.
11320154|NCT03300570|EG001|Reported Event|Arm B (Dolcanatide)|Participants receive dolcanatide PO QD for 7 days. All participants will undergo sigmoidoscopies at baseline and after seven days of daily dosing with dolcanatide.
11320155|NCT03300674|BG000|Baseline|Intravenous Hydromorphone|"Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.~Hydromorphone: Hydromorphone intravenous infusion"
11320156|NCT03300674|BG001|Baseline|Intravenous Lidocaine|"Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes~Lidocaine: Lidocaine intravenous infusion"
11320157|NCT03300674|BG002|Baseline|Total|Total of all reporting groups
11320158|NCT03300674|FG000|Participant Flow|Intravenous Hydromorphone|"Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.~Hydromorphone: Hydromorphone intravenous infusion"
11320159|NCT03300674|FG001|Participant Flow|Intravenous Lidocaine|"Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes~Lidocaine: Lidocaine intravenous infusion"
11320160|NCT03300674|OG000|Outcome|Intravenous Hydromorphone|"Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.~Hydromorphone: Hydromorphone intravenous infusion"
11320161|NCT03300674|OG001|Outcome|Intravenous Lidocaine|"Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes~Lidocaine: Lidocaine intravenous infusion"
11320162|NCT03300674|EG000|Reported Event|Intravenous Hydromorphone|"Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.~Hydromorphone: Hydromorphone intravenous infusion"
11320163|NCT03300674|EG001|Reported Event|Intravenous Lidocaine|"Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes~Lidocaine: Lidocaine intravenous infusion"
11320164|NCT03300752|BG000|Baseline|BREATHE Intervention|"The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.~BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment."
11320165|NCT03300752|BG001|Baseline|Control Intervention|"The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).~Control Intervention: PCP will provide discussion of healthy lifestyles."
11320166|NCT03300752|BG002|Baseline|Total|Total of all reporting groups
11320167|NCT03300752|FG000|Participant Flow|BREATHE Intervention|"The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.~BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment."
11320168|NCT03300752|FG001|Participant Flow|Control Intervention|"The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).~Control Intervention: PCP will provide discussion of healthy lifestyles."
11320169|NCT03300752|OG000|Outcome|BREATHE Intervention|"The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.~BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment."
11320170|NCT03300752|OG001|Outcome|Control Intervention|"The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).~Control Intervention: PCP will provide discussion of healthy lifestyles."
11320171|NCT03300752|EG000|Reported Event|BREATHE Intervention|"The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.~BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment."
11320172|NCT03300752|EG001|Reported Event|Control Intervention|"The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).~Control Intervention: PCP will provide discussion of healthy lifestyles."
11320173|NCT03300843|BG000|Baseline|Peptide Loaded Dendritic Cell Vaccine|"Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42~Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield."
11320174|NCT03300843|FG000|Participant Flow|Peptide Loaded Dendritic Cell Vaccine|"Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42~Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield."
11320175|NCT03300843|OG000|Outcome|Peptide Loaded Dendritic Cell Vaccine|"Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42~Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield."
11320176|NCT03300843|EG000|Reported Event|Peptide Loaded Dendritic Cell Vaccine|"Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42~Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield."
11320177|NCT03301155|BG000|Baseline|Anaferon for Children|"Tablet for oral use. One tablet per intake, once daily (approximately at the same time).~The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.~Anaferon for children: Tablet for oral use."
11320178|NCT03301155|BG001|Baseline|Placebo|"Tablet for oral use. Placebo using Anaferon for children scheme.~Placebo: Tablet for oral use."
11320179|NCT03301155|BG002|Baseline|Total|Total of all reporting groups
11320180|NCT03301155|FG000|Participant Flow|Anaferon for Children|"Tablet for oral use. One tablet per intake, once daily (approximately at the same time).~The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.~Anaferon for children: Tablet for oral use."
11320181|NCT03301155|FG001|Participant Flow|Placebo|"Tablet for oral use. Placebo using Anaferon for children scheme.~Placebo: Tablet for oral use."
11320182|NCT03301155|OG000|Outcome|Anaferon for Children|"Tablet for oral use. One tablet per intake, once daily (approximately at the same time).~The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.~Anaferon for children: Tablet for oral use."
11320183|NCT03301155|OG001|Outcome|Placebo|"Tablet for oral use. Placebo using Anaferon for children scheme.~Placebo: Tablet for oral use."
11320184|NCT03301155|EG000|Reported Event|Anaferon for Children|"Tablet for oral use. One tablet per intake, once daily (approximately at the same time).~The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.~Anaferon for children: Tablet for oral use."
11320185|NCT03301155|EG001|Reported Event|Placebo|"Tablet for oral use. Placebo using Anaferon for children scheme.~Placebo: Tablet for oral use."
11320186|NCT03301272|BG000|Baseline|OnabotulinumtoxinA Injection, Then Placebo|"Participants first receive OnabotulinumtoxinA Injection and following a 3-month washout, they receive Placebo~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320187|NCT03301272|BG001|Baseline|Placebo, Then OnabotulinumtoxinA Injection|"Participants first receive placebo injection and following a 3-month washout, they receive OnabotulinumtoxinA Injection.~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320188|NCT03301272|BG002|Baseline|Total|Total of all reporting groups
11320189|NCT03301272|FG000|Participant Flow|OnabotulinumtoxinA Injection, Then Placebo|"Participants first receive OnabotulinumtoxinA Injection and following a 3-month washout, they receive Placebo~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320190|NCT03301272|FG001|Participant Flow|Placebo, Then OnabotulinumtoxinA Injection|"Participants first receive placebo injection and following a 3-month washout, they receive Onabotulinumtoxin A Injection.~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320191|NCT03301272|OG000|Outcome|OnabotulinumtoxinA Injection|"Participants receive OnabotulinumtoxinA Injection.~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once"
11320192|NCT03301272|OG001|Outcome|Placebo|"Participants receive placebo injection.~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320193|NCT03301272|EG000|Reported Event|Onabotulinumtoxin A Injection|"Participants receive Onabotulinumtoxin A Injection.~OnabotulinumtoxinA Injection: Reconstituted 10 units/0.1 mL. Administered intramuscular once"
11320194|NCT03301272|EG001|Reported Event|Placebo|"Participants receive placebo injection.~Placebo: 0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once."
11320195|NCT03301298|BG000|Baseline|SXC-2023, 50 mg|"Single dose of 50 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320196|NCT03301298|BG001|Baseline|SXC-2023, 100 mg|"Single dose of 100 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320197|NCT03301298|BG002|Baseline|SXC-2023, 200 mg|"Single dose of 200mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320198|NCT03301298|BG003|Baseline|SXC-2023, 400 mg|"Single dose of 400mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320199|NCT03301298|BG004|Baseline|SXC-2023, 800 mg|"Single dose of 800mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320200|NCT03301298|BG005|Baseline|SXC-2023, 1600 mg|"Single dose of 1600 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320201|NCT03301298|BG006|Baseline|Placebo|"Placebo comparator, given once orally in matching capsule form.~Placebo oral capsule: Placebo given as oral capsule."
11320202|NCT03301298|BG007|Baseline|Total|Total of all reporting groups
11320203|NCT03301298|FG000|Participant Flow|SXC-2023, 50 mg|"Single dose of 50 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320204|NCT03301298|FG001|Participant Flow|SXC-2023, 100 mg|"Single dose of 100 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320205|NCT03301298|FG002|Participant Flow|SXC-2023, 200 mg|"Single dose of 200mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320206|NCT03301298|FG003|Participant Flow|SXC-2023, 400 mg|"Single dose of 400mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320207|NCT03301298|FG004|Participant Flow|SXC-2023, 800 mg|"Single dose of 800mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320208|NCT03301298|FG005|Participant Flow|SXC-2023, 1600 mg|"Single dose of 1600 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320209|NCT03301298|FG006|Participant Flow|Placebo|"Placebo comparator, given once orally in matching capsule form.~Placebo oral capsule: Placebo given as oral capsule."
11320210|NCT03301298|OG000|Outcome|SXC-2023, 50 mg|"Single dose of 50 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320211|NCT03301298|OG001|Outcome|SXC-2023, 100 mg|"Single dose of 100 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320212|NCT03301298|OG002|Outcome|SXC-2023, 200 mg|"Single dose of 200mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320213|NCT03301298|OG003|Outcome|SXC-2023, 400 mg|"Single dose of 400mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320214|NCT03301298|OG004|Outcome|SXC-2023, 800 mg|"Single dose of 800mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320215|NCT03301298|OG005|Outcome|SXC-2023, 1600 mg|"Single dose of 1600 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320216|NCT03301298|OG006|Outcome|Placebo Oral Capsule|"Placebo comparator, given once orally in matching capsule form.~Placebo oral capsule: Placebo given as oral capsule."
11320217|NCT03301298|OG000|Outcome|SXC-2023, 800 mg Fed|Single dose of 800 mg, given orally in capsule form under fed conditions.
11320218|NCT03301298|EG000|Reported Event|SXC-2023, 50 mg|"Single dose of 50 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320219|NCT03301298|EG001|Reported Event|SXC-2023, 100 mg|"Single dose of 100 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320220|NCT03301298|EG002|Reported Event|SXC-2023, 200 mg|"Single dose of 200mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320221|NCT03301298|EG003|Reported Event|SXC-2023, 400 mg|"Single dose of 400mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320222|NCT03301298|EG004|Reported Event|SXC-2023, 800 mg|"Single dose of 800mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320223|NCT03301298|EG005|Reported Event|SXC-2023, 1600 mg|"Single dose of 1600 mg, given orally in capsule form.~SXC-2023: Oral capsule"
11320224|NCT03301298|EG006|Reported Event|Placebo|"Placebo comparator, given once orally in matching capsule form.~Placebo oral capsule: Placebo given as oral capsule."
11333388|NCT03513757|BG000|Baseline|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists"
11333389|NCT03513757|BG001|Baseline|Propofol Dexmedetomidine|"Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mic/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mic/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mic/kg/min. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists~Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg"
11333390|NCT03513757|BG002|Baseline|Total|Total of all reporting groups
11333391|NCT03513757|FG000|Participant Flow|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists"
11333392|NCT03513757|FG001|Participant Flow|Propofol Dexmedetomidine|"Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists~Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg"
11333393|NCT03513757|OG000|Outcome|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists"
11333394|NCT03513757|OG001|Outcome|Propofol Dexmedetomidine|"Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists.~Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg.~Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group."
11333395|NCT03513757|OG000|Outcome|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists"
11335965|NCT03559179|OG001|Outcome|Non-Waivered Providers Who Received the Opioid Wizard|"Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents non-waivered providers who received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
11320225|NCT03301623|BG000|Baseline|Clinical Decision Support|"Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately.~Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication."
11320226|NCT03301623|BG001|Baseline|Patient Education and Activation Tools|"Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP.~Patient Education and Activation Tools: The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication)."
11320227|NCT03301623|BG002|Baseline|Total|Total of all reporting groups
11320228|NCT03301623|FG000|Participant Flow|Clinical Decision Support|"Patients within the physicians randomized to the Informed Decision Making (IDM) arm will receive the Clinical Decision Support alerts via the Electronic Health Record (EHR) when certain order criteria are triggered appropriately.~Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication."
11320229|NCT03301623|FG001|Participant Flow|Patient Education and Activation Tools|"Patients within the physicians randomized to Shared Decision Making (SDM) will receive the PEAT materials via REDCap two days prior to their Primary Care Physician (PCP) office visit. They will receive these materials every time they have an office visit with their PCP.~Patient Education and Activation Tools: The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication)."
11320230|NCT03301623|OG000|Outcome|Clinical Decision Support|"Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately.~Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication."
11320231|NCT03301623|OG001|Outcome|Patient Education and Activation Tools|"Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP.~Patient Education and Activation Tools: The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication)."
11320232|NCT03301623|EG000|Reported Event|Clinical Decision Support|"Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately.~Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication."
11320233|NCT03301623|EG001|Reported Event|Patient Education and Activation Tools|"Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP.~Patient Education and Activation Tools: The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication)."
11320234|NCT03301649|BG000|Baseline|Generic Ivermectin Lotion 0.5%|Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320235|NCT03301649|BG001|Baseline|Sklice (Ivermectin) Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11333396|NCT03513757|OG000|Outcome|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists."
11320236|NCT03301649|BG002|Baseline|Vehicle Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320237|NCT03301649|BG003|Baseline|Total|Total of all reporting groups
11320238|NCT03301649|FG000|Participant Flow|Generic Ivermectin Lotion 0.5%|Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320239|NCT03301649|FG001|Participant Flow|Sklice (Ivermectin) Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320240|NCT03301649|FG002|Participant Flow|Vehicle Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320241|NCT03301649|OG000|Outcome|Generic Ivermectin Lotion 0.5%|Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320242|NCT03301649|OG001|Outcome|Sklice (Ivermectin) Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320243|NCT03301649|OG002|Outcome|Vehicle Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320244|NCT03301649|EG000|Reported Event|Generic Ivermectin Lotion 0.5%|Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320245|NCT03301649|EG001|Reported Event|Vehicle Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11335966|NCT03559179|OG002|Outcome|Non-Waivered Providers Who Did Not Receive the Opioid Wizard|These are non-buprenorphine waivered providers continued to treat their patients as usual.
11335967|NCT03559179|EG000|Reported Event|Waivered Providers Who Received the Opioid Wizard|"These providers received the OUD clinical decision support tool (Opioid Wizard).~Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers."
10843007|NCT00251316|OG000|Outcome|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
11320246|NCT03301649|EG002|Reported Event|Sklice (Ivermectin) Lotion|Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
11320247|NCT03301714|BG000|Baseline|Control|Regular dental care under the standard clinic operation
11320248|NCT03301714|BG001|Baseline|Intervention 1|"Group based oral health education~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320249|NCT03301714|BG002|Baseline|Intervention 2|"Individual-based motivational interviewing~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320250|NCT03301714|BG003|Baseline|Total|Total of all reporting groups
11320251|NCT03301714|FG000|Participant Flow|Control: Standard of Care|Regular dental care under the standard clinic operation
11320252|NCT03301714|FG001|Participant Flow|Intervention 1: Group-based Oral Health Education|"Group based oral health education~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320253|NCT03301714|FG002|Participant Flow|Intervention 2:Individual-based Oral Health Education Using MI|"Individual-based motivational interviewing~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320254|NCT03301714|OG000|Outcome|Control|Regular dental care under the standard clinic operation
11320255|NCT03301714|OG001|Outcome|Intervention 1|"Group based oral health education~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320256|NCT03301714|OG002|Outcome|Intervention 2|"Individual-based motivational interviewing~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320257|NCT03301714|OG000|Outcome|Control: Standard of Care|Regular dental care under the standard clinic operation
11320258|NCT03301714|OG001|Outcome|Intervention 1: Group-based Oral Health Education|"Group based oral health education~Oral Health Education: Group-based oral health education vs Individual-based oral health education using motivational interviewing"
11320259|NCT03301714|OG002|Outcome|Intervention 2: Individual-based Oral Health Education|"Individual-based motivational interviewing~Oral Health Education: Group-based oral health education vs Individual-based oral health education using motivational interviewing"
11320260|NCT03301714|EG000|Reported Event|Control|Regular dental care under the standard clinic operation
11320261|NCT03301714|EG001|Reported Event|Intervention 1|"Group based oral health education~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320262|NCT03301714|EG002|Reported Event|Intervention 2|"Individual-based motivational interviewing~Oral Health Education: Group based oral health education vs Individual motivational interviewing"
11320263|NCT03301740|BG000|Baseline|UF Profiling Phase First|"First treatment phase begins with linear UF profiling during HD.~Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase)."
11320264|NCT03301740|BG001|Baseline|Conventional HD Phase First|"First treatment phase begins with conventional HD.~Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase)."
11320265|NCT03301740|BG002|Baseline|Total|Total of all reporting groups
11320266|NCT03301740|FG000|Participant Flow|UF Profiling Phase First|"First treatment phase begins with linear UF profiling during HD.~Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase)."
11320267|NCT03301740|FG001|Participant Flow|Conventional HD Phase First|"First treatment phase begins with conventional HD.~Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase)."
11320268|NCT03301740|OG000|Outcome|UF Profiling|"Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed profile 2 on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions."
11320269|NCT03301740|OG001|Outcome|Conventional HD|Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
11320270|NCT03301740|EG000|Reported Event|UF Profiling|"Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed profile 2 on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions."
11320271|NCT03301740|EG001|Reported Event|Conventional HD|Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
11320272|NCT03301779|BG000|Baseline|All Study Donors|This study was a crossover design and all Donors donated units to both the Investigation and Control arms so the Baseline Measures for all donors are combined here irrespective of their randomization.
11320273|NCT03301779|FG000|Participant Flow|Investigational Product First, Then Control Product|"A donor randomized to this arm donated their first whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.~These donors then donated their second whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C."
11320274|NCT03301779|FG001|Participant Flow|Control Product First, Then Investigational Product|"A donor randomized to this arm donated their first whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C.~These donors then donated their second whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C."
11320275|NCT03301779|OG000|Outcome|Investigational Product|"Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.~Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C."
11320276|NCT03301779|OG001|Outcome|Control Product|Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
11320277|NCT03301779|EG000|Reported Event|Investigational Product|"Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.~Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C."
11320278|NCT03301779|EG001|Reported Event|Control Product|Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
11320279|NCT03301831|BG000|Baseline|Resourcefulness Training Intervention|"The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.~Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills."
11320280|NCT03301831|BG001|Baseline|Attention Control|The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
11320281|NCT03301831|BG002|Baseline|Total|Total of all reporting groups
11320282|NCT03301831|FG000|Participant Flow|Resourcefulness Training Intervention|"The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.~Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills."
11320283|NCT03301831|FG001|Participant Flow|Attention Control|The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
11320284|NCT03301831|OG000|Outcome|Resourcefulness Training Intervention|"The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.~Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills."
11320285|NCT03301831|OG001|Outcome|Attention Control|The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
11320286|NCT03301831|EG000|Reported Event|Resourcefulness Training Intervention|"The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.~Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills."
11320287|NCT03301831|EG001|Reported Event|Attention Control|The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
11320288|NCT03301844|BG000|Baseline|Study Treatment|"Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.~Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.~The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes."
11320289|NCT03301844|BG001|Baseline|Standard Treatment|"Wet, warm gauze twice daily for one month.~Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze."
11320290|NCT03301844|BG002|Baseline|Total|Total of all reporting groups
11320291|NCT03301844|FG000|Participant Flow|Study Treatment|"Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.~Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.~The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes."
10827816|NCT00112047|FG001|Participant Flow|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
11320292|NCT03301844|FG001|Participant Flow|Standard Treatment|"Wet, warm gauze twice daily for one month.~Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze."
11320293|NCT03301844|OG000|Outcome|Study Treatment|"Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.~Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.~The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes."
11320294|NCT03301844|OG001|Outcome|Standard Treatment|"Wet, warm gauze twice daily for one month.~Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze."
11320295|NCT03301844|EG000|Reported Event|Study Treatment|"Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.~Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.~The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes."
11320296|NCT03301844|EG001|Reported Event|Standard Treatment|"Wet, warm gauze twice daily for one month.~Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze."
11320297|NCT03302091|BG000|Baseline|BI 1467335 Normal (R)|Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320298|NCT03302091|BG001|Baseline|BI 1467335 Moderate (T)|Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320299|NCT03302091|BG002|Baseline|Total|Total of all reporting groups
11320300|NCT03302091|FG000|Participant Flow|BI 1467335 Normal (R)|Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320301|NCT03302091|FG001|Participant Flow|BI 1467335 Moderate (T)|Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320302|NCT03302091|OG000|Outcome|BI 1467335 Normal (R)|Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320303|NCT03302091|OG001|Outcome|BI 1467335 Moderate (T)|Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320304|NCT03302091|EG000|Reported Event|BI 1467335 Normal (R)|Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320305|NCT03302091|EG001|Reported Event|BI 1467335 Moderate (T)|Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
11320306|NCT03302416|BG000|Baseline|[C-11]NOP-1A PET Scan Conditions|"Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition~Hydrocortisone~[C-11]NOP-1A"
11320307|NCT03302416|FG000|Participant Flow|[C-11]NOP-1A PET Scan Conditions|"Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition~Hydrocortisone~[C-11]NOP-1A"
11320308|NCT03302416|OG000|Outcome|Baseline Participants|Healthy Controls
11320309|NCT03302416|EG000|Reported Event|[C-11]NOP-1A PET Scan Conditions|"Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition~Hydrocortisone~[C-11]NOP-1A"
11320310|NCT03302559|BG000|Baseline|Retinol Complex 0.5|During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
11320311|NCT03302559|FG000|Participant Flow|Retinol Complex 0.5|During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
11320312|NCT03302559|OG000|Outcome|Retinol Complex 0.5|During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
11335968|NCT03559179|EG001|Reported Event|Non-Waivered Providers Who Received the Opioid Wizard|"Non-waivered providers were randomized to receive/not receive the Opioid Wizard.~This arm represents the providers who received access to the opioid wizard."
11320313|NCT03302559|EG000|Reported Event|Retinol Complex 0.5|During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
11320314|NCT03302741|BG000|Baseline|Standard BTX Injection (Ultrasound Guided)|For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the IZs of the entire muscle.
11320315|NCT03302741|BG001|Baseline|3-dimensional Innervation Zone (3DIZ) Guided Injection|In the IZ-guided injection technique, IZ location obtained using the 3DIZ will be first marked over the skin surface of the muscle and the depth of the IZ will be also provided. The 3DIZ will be applied to the IZ-guided injection group 1 day prior to scheduled injection. The surface location and depth information of the IZ will be used to guide where the needle tip needs to go. Currently, patients commonly receive 1 to 2 injection sites, occasionally 3 sites for biceps muscles. To standardize the procedure, we will choose 2 sites for all patients.
11320316|NCT03302741|BG002|Baseline|Total|Total of all reporting groups
11320317|NCT03302741|FG000|Participant Flow|Standard BTX Injection (Ultrasound Guided)|For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the IZs of the entire muscle.
11320318|NCT03302741|FG001|Participant Flow|3-dimensional Innervation Zone (3DIZ) Guided Injection|In the IZ-guided injection technique, IZ location obtained using the 3DIZ will be first marked over the skin surface of the muscle and the depth of the IZ will be also provided. The 3DIZ will be applied to the IZ-guided injection group 1 day prior to scheduled injection. The surface location and depth information of the IZ will be used to guide where the needle tip needs to go. Currently, patients commonly receive 1 to 2 injection sites, occasionally 3 sites for biceps muscles. To standardize the procedure, we will choose 2 sites for all patients.
11320319|NCT03302741|OG000|Outcome|Standard BTX Injection (Ultrasound Guided)|For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the IZs of the entire muscle.
11320320|NCT03302741|OG001|Outcome|3-dimensional Innervation Zone (3DIZ) Guided Injection|In the IZ-guided injection technique, IZ location obtained using the 3DIZ will be first marked over the skin surface of the muscle and the depth of the IZ will be also provided. The 3DIZ will be applied to the IZ-guided injection group 1 day prior to scheduled injection. The surface location and depth information of the IZ will be used to guide where the needle tip needs to go. Currently, patients commonly receive 1 to 2 injection sites, occasionally 3 sites for biceps muscles. To standardize the procedure, we will choose 2 sites for all patients.
11320321|NCT03302741|EG000|Reported Event|Standard BTX Injection (Ultrasound Guided)|For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the IZs of the entire muscle.
11320322|NCT03302741|EG001|Reported Event|3-dimensional Innervation Zone (3DIZ) Guided Injection|In the IZ-guided injection technique, IZ location obtained using the 3DIZ will be first marked over the skin surface of the muscle and the depth of the IZ will be also provided. The 3DIZ will be applied to the IZ-guided injection group 1 day prior to scheduled injection. The surface location and depth information of the IZ will be used to guide where the needle tip needs to go. Currently, patients commonly receive 1 to 2 injection sites, occasionally 3 sites for biceps muscles. To standardize the procedure, we will choose 2 sites for all patients.
11320323|NCT03302767|BG000|Baseline|Psychological and Social Consultation|Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
11320324|NCT03302767|FG000|Participant Flow|Psychological and Social Consultation|Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
11320325|NCT03302767|OG000|Outcome|Psychological and Social Consultation|Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
11320326|NCT03302767|EG000|Reported Event|Psychological and Social Consultation|Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
11320327|NCT03302780|BG000|Baseline|All Participants|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320328|NCT03302780|FG000|Participant Flow|Sham tDCS and BreEStim; Then M1 tDCS and BreEstim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320329|NCT03302780|FG001|Participant Flow|M1 tDCS and BreEStim; Then Sham tDCS and BreEstim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320330|NCT03302780|OG000|Outcome|Sham tDCS and BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320331|NCT03302780|OG001|Outcome|Active tDCS (M1) and BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320332|NCT03302780|EG000|Reported Event|Sham tDCS and BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320333|NCT03302780|EG001|Reported Event|Active tDCS (M1) and BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320334|NCT03302793|BG000|Baseline|All Participants|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320335|NCT03302793|FG000|Participant Flow|Sham tDCS and Then BreEStim; Then M1 tDCS and Then BreEstim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320336|NCT03302793|FG001|Participant Flow|M1 tDCS and Then BreEStim; Then Sham tDCS and Then BreEstim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320337|NCT03302793|OG000|Outcome|Sham tDCS and Then BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320338|NCT03302793|OG001|Outcome|Active tDCS (M1) and Then BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320339|NCT03302793|EG000|Reported Event|Sham tDCS and Then BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320340|NCT03302793|EG001|Reported Event|Active tDCS (M1) and Then BreEStim|This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
11320341|NCT03302936|BG000|Baseline|Pyridium Arm|"Phenazopyridine 200mg tablet, once prior to surgery~Phenazopyridine: to be given preoperatively"
11320342|NCT03302936|BG001|Baseline|Control Arm|No intervention in this group. Routine perioperative care.
11320343|NCT03302936|BG002|Baseline|Total|Total of all reporting groups
11320344|NCT03302936|FG000|Participant Flow|Pyridium Arm|"Phenazopyridine 200mg tablet, once prior to surgery~Phenazopyridine: to be given preoperatively"
11320345|NCT03302936|FG001|Participant Flow|Control Arm Vitamin B-6 as Placebo|Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care.
11320346|NCT03302936|OG000|Outcome|Pyridium Arm|"Phenazopyridine 200mg tablet, once prior to surgery~Phenazopyridine: to be given preoperatively~Failed void trial, 16 participants or 34.5% in the phenazopyridine arm."
11320347|NCT03302936|OG001|Outcome|Control Arm|"Vitamin B-6 as placebo. Routine perioperative care.~Failed void trial, 15 participants or 33.3% in the placebo arm."
11320348|NCT03302936|OG000|Outcome|Urinary Retention in Pyridium|Urinary retention is the same value as failed void trial in both arms
11320349|NCT03302936|OG001|Outcome|Urinary Retention in Placebo|Urinary retention is the same value as failed void trial
11320350|NCT03302936|OG000|Outcome|Pain Scale in Pyridium Arm|At time of void, pain on a VAS scale from 0-10
11320351|NCT03302936|OG001|Outcome|Pain Scale in Placebo Arm|At time of void pain on a VAS scale from 0-10
11320352|NCT03302936|EG000|Reported Event|Pyridium|Phenazopyridine 200mg tablet, once prior to surgery
11320353|NCT03302936|EG001|Reported Event|Placebo|Vitamin B-6 50mg given once prior to surgery as placebo.
11320354|NCT03302975|BG000|Baseline|Real Time Biofeedback|"Real-time visual biofeedback of braking forces during a treadmill run.~Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running"
11320355|NCT03302975|FG000|Participant Flow|Real Time Biofeedback|"Real-time visual biofeedback of braking forces during a treadmill run.~Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running"
11320356|NCT03302975|OG000|Outcome|Real Time Biofeedback|"Real-time visual biofeedback of braking forces during a treadmill run.~Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running"
11320357|NCT03302975|EG000|Reported Event|Real Time Biofeedback|"Real-time visual biofeedback of braking forces during a treadmill run.~Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running"
11320358|NCT03303079|BG000|Baseline|TEV-48125 (675/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
11320359|NCT03303079|BG001|Baseline|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).
11320360|NCT03303079|BG002|Baseline|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320361|NCT03303079|BG003|Baseline|Total|Total of all reporting groups
11320362|NCT03303079|FG000|Participant Flow|TEV-48125 (675/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
11320363|NCT03303079|FG001|Participant Flow|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).
11320364|NCT03303079|FG002|Participant Flow|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320365|NCT03303079|OG000|Outcome|TEV-48125 (675/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
11320366|NCT03303079|OG001|Outcome|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).
11320367|NCT03303079|OG002|Outcome|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320368|NCT03303079|EG000|Reported Event|TEV-48125 (675/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).
11320369|NCT03303079|EG001|Reported Event|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).
11320370|NCT03303079|EG002|Reported Event|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320371|NCT03303092|BG000|Baseline|TEV-48125 (225/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
11320372|NCT03303092|BG001|Baseline|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
11320373|NCT03303092|BG002|Baseline|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320374|NCT03303092|BG003|Baseline|Total|Total of all reporting groups
11320375|NCT03303092|FG000|Participant Flow|TEV-48125 (225/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
11320376|NCT03303092|FG001|Participant Flow|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
11320377|NCT03303092|FG002|Participant Flow|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320378|NCT03303092|OG000|Outcome|TEV-48125 (225/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
11320379|NCT03303092|OG001|Outcome|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
11320380|NCT03303092|OG002|Outcome|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320381|NCT03303092|EG000|Reported Event|TEV-48125 (225/225/225 mg) Group|TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
11320382|NCT03303092|EG001|Reported Event|TEV-48125 (675 mg/Placebo/Placebo) Group|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
11320383|NCT03303092|EG002|Reported Event|Placebo Group|Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
11320384|NCT03303105|BG000|Baseline|TEV-48125 (225 mg/1 Month) Group|TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).
11320385|NCT03303105|BG001|Baseline|TEV-48125 (675 mg/3 Month) Group|TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
11320386|NCT03303105|BG002|Baseline|Total|Total of all reporting groups
11320387|NCT03303105|FG000|Participant Flow|TEV-48125 (225 mg/1 Month) Group|TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).
11320388|NCT03303105|FG001|Participant Flow|TEV-48125 (675 mg/3 Month) Group|TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
11320389|NCT03303105|OG000|Outcome|TEV-48125 (225 mg/1 Month) Group|TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).
11320390|NCT03303105|OG001|Outcome|TEV-48125 (675 mg/3 Month) Group|TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
11320391|NCT03303105|EG000|Reported Event|TEV-48125 (225 mg/1 Month) Group|TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).
11320392|NCT03303105|EG001|Reported Event|TEV-48125 (675 mg/3 Month) Group|TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
11320393|NCT03303144|BG000|Baseline|Safety Population|All patients in study
11320394|NCT03303144|FG000|Participant Flow|Triferic Via Hemodialysate (Day 3)|Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
11320395|NCT03303144|FG001|Participant Flow|Triferic Via IV Infusion( Pre-dialyzer) (Day 8)|Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
11320396|NCT03303144|FG002|Participant Flow|Triferic Via IV Infusion (Post-dialyzer) (Day 10)|Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
11320397|NCT03303144|OG000|Outcome|Triferic Via Hemodialysate|"Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.~Triferic: ferric pyrophosphate citrate"
11320398|NCT03303144|OG000|Outcome|Triferic Via IV Infusion( Pre-dialyzer)|"Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)~Triferic: ferric pyrophosphate citrate"
11320399|NCT03303144|OG001|Outcome|Triferic Via IV Infusion (Post-dialyzer)|"Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)~Triferic: ferric pyrophosphate citrate"
11320400|NCT03303144|OG002|Outcome|Triferic Via Hemodialysate|Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
11320401|NCT03303144|OG000|Outcome|Triferic Via IV Infusion( Pre-dialyzer)|Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
11320402|NCT03303144|OG001|Outcome|Triferic Via IV Infusion (Post-dialyzer)|Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
11320403|NCT03303144|EG000|Reported Event|Triferic Via Hemodialysate|"Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.~Triferic: ferric pyrophosphate citrate"
11320404|NCT03303144|EG001|Reported Event|Triferic Via IV Infusion( Pre-dialyzer)|"Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)~Triferic: ferric pyrophosphate citrate"
11320405|NCT03303144|EG002|Reported Event|Triferic Via IV Infusion (Post-dialyzer)|"Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)~Triferic: ferric pyrophosphate citrate"
11320406|NCT03303196|BG000|Baseline|Sequential Admissions|"Bihormonal bionic pancreas admission: Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.~*before or after* Standard care admission: Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff."
11320407|NCT03303196|FG000|Participant Flow|Bihormonal Bionic Pancreas Admission|Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
11320408|NCT03303196|FG001|Participant Flow|Standard Care Admission|Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
11320409|NCT03303196|OG000|Outcome|Sequential Admissions|"Bihormonal bionic pancreas admission: Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.~*before or after* Standard care admission: Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff."
11320410|NCT03303196|EG000|Reported Event|Bihormonal Bionic Pancreas Admission|Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
11320411|NCT03303196|EG001|Reported Event|Standard Care Admission|Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
11320412|NCT03303404|BG000|Baseline|Ambulatory (24-hour) Blood Pressure|Ambulatory (24-hour) Blood Pressure: Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period.
11320413|NCT03303404|FG000|Participant Flow|Ambulatory (24-hour) Blood Pressure|Ambulatory (24-hour) Blood Pressure: Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period.
11320414|NCT03303404|OG000|Outcome|Intervention|This is a single arm acute intervention study.
11320415|NCT03303404|EG000|Reported Event|Intervention|This is a single arm study did not involve grouping.
11320416|NCT03303417|BG000|Baseline|All Study Participants|"All participants randomised to either Kiwifruit then Control or Control then Kiwifruit Interventions"
11320417|NCT03303417|FG000|Participant Flow|Kiwifruit Then Control|"Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit.~Washout period of 2 weeks~Then~Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink"
11320418|NCT03303417|FG001|Participant Flow|Control Then Kiwifruit|"Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan~MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content~calorie-matched sugar drink: calorie-matched sugar drink~Washout of 2 weeks~Then Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit"
11320419|NCT03303417|OG000|Outcome|Kiwifruit|"Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan~MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content~Kiwifruit: Kiwifruit"
11320420|NCT03303417|OG001|Outcome|Control|"Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan~MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content~calorie-matched sugar drink: calorie-matched sugar drink"
11320421|NCT03303417|EG000|Reported Event|Kiwifruit|"Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan~MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content~Kiwifruit: Kiwifruit"
11320422|NCT03303417|EG001|Reported Event|Control|"Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan~MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content~calorie-matched sugar drink: calorie-matched sugar drink"
11320423|NCT03303521|BG000|Baseline|Sodium Zirconium Cyclosilicate (SZC)|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320424|NCT03303521|BG001|Baseline|Placebo|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320425|NCT03303521|BG002|Baseline|Total|Total of all reporting groups
11320426|NCT03303521|FG000|Participant Flow|Sodium Zirconium Cyclosilicate (SZC)|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320427|NCT03303521|FG001|Participant Flow|Placebo|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320428|NCT03303521|OG000|Outcome|Sodium Zirconium Cyclosilicate (SZC)|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320429|NCT03303521|OG001|Outcome|Placebo|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320430|NCT03303521|EG000|Reported Event|Sodium Zirconium Cyclosilicate (SZC)|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320431|NCT03303521|EG001|Reported Event|Placebo|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).~Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days."
11320432|NCT03303794|BG000|Baseline|Bupivicaine|"0.25% bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320433|NCT03303794|BG001|Baseline|Bupivicaine + Exparel|"0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320434|NCT03303794|BG002|Baseline|Total|Total of all reporting groups
11320435|NCT03303794|FG000|Participant Flow|Bupivicaine|"0.25% bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320436|NCT03303794|FG001|Participant Flow|Bupivicaine + Exparel|"0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320437|NCT03303794|OG000|Outcome|Bupivicaine|"0.25% bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320438|NCT03303794|OG001|Outcome|Bupivicaine + Exparel|"0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320439|NCT03303794|EG000|Reported Event|Bupivicaine|"0.25% bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320440|NCT03303794|EG001|Reported Event|Bupivicaine + Exparel|"0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty~0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty"
11320441|NCT03303911|BG000|Baseline|Cytisine 1.5 mg|"Multiple doses of 1.5 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320442|NCT03303911|BG001|Baseline|Cytisine 3.0 mg|"Multiple doses of 3.0 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320443|NCT03303911|BG002|Baseline|Total|Total of all reporting groups
11320444|NCT03303911|FG000|Participant Flow|Cytisine 1.5 mg|"Multiple doses of 1.5 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320445|NCT03303911|FG001|Participant Flow|Cytisine 3.0 mg|"Multiple doses of 3.0 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320446|NCT03303911|OG000|Outcome|Cytisine 1.5 mg|"Multiple doses of 1.5 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320447|NCT03303911|OG001|Outcome|Cytisine 3.0 mg|"Multiple doses of 3.0 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320448|NCT03303911|EG000|Reported Event|Cytisine 1.5 mg|"Multiple doses of 1.5 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320449|NCT03303911|EG001|Reported Event|Cytisine 3.0 mg|"Multiple doses of 3.0 mg cytisine administered per 25-day schedule:~Days 1-3 (6 times daily)~Days 4-12 (5 times daily)~Days 13-16 (4 times daily)~Days 17-20 (3 times daily)~Days 21-24 (2 times daily)~Day 25 (Once daily)"
11320450|NCT03304054|BG000|Baseline|Amifampridine Phosphate|Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
11320451|NCT03304054|BG001|Baseline|Placebo|Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day
11320452|NCT03304054|BG002|Baseline|Amifampridine Phosphate Only|Patients receiving Amifampridine during the open-label Run-in period but were not randomized for the crossover portion of the study.
11320453|NCT03304054|BG003|Baseline|Total|Total of all reporting groups
11320454|NCT03304054|FG000|Participant Flow|Amifampridine Phosphate - MuSK|"Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day~MuSK - patients diagnosed with MuSK-MG"
11320455|NCT03304054|FG001|Participant Flow|Amifampridine Phosphate - AChR-MG|"Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day~AChR-MG- patients diagnosed with AChR-MG"
11320456|NCT03304054|FG002|Participant Flow|Placebo - MuSk|"Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day~MuSK - patients diagnosed with MuSK-MG"
11320457|NCT03304054|FG003|Participant Flow|Placebo - AChR-MG|"Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day~AChR-MG- patients diagnosed with AChR-MG"
11320458|NCT03304054|FG004|Participant Flow|Amifampridine Phosphate Only - MuSK|Patients receiving amifampridine during the open-label run-in period but were not randomized for the crossover portion of the study and diagnosed with MuSK-MG.
11320459|NCT03304054|FG005|Participant Flow|Amifampridine Phosphate Only- AChR-MG|Patients receiving amifampridine during the open-label run-in period but were not randomized for the crossover portion of the study and diagnosed with AChR-MG.
11320460|NCT03304054|OG000|Outcome|Amifampridine Phosphate - MuSK|"Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day~Patients randomized to receive Amifampridine and diagnosed with MuSK-MG."
11320461|NCT03304054|OG001|Outcome|Placebo - MuSK|"Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day~Patients randomized to receive Placebo and diagnosed with MuSK-MG."
11320462|NCT03304054|OG002|Outcome|Amifampridine Phosphate - AChR|"Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day~Patients randomized to receive Amifampridine and diagnosed with AChR-MG."
11320463|NCT03304054|OG003|Outcome|Placebo - AChR|"Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day~Patients randomized to receive Placebo and diagnosed with AChR-MG."
11320464|NCT03304054|EG000|Reported Event|Amifampridine Phosphate|"Amifampridine Phosphate: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day.~The AEs reported within this treatment arm are those experienced by all participants who received Amifampridine Phosphate at the time of onset of the AE. Because this study has a run-in period where all subjects received Amifampridine Phosphate, the number of at-risk subjects in this treatment arm is identical to the overall number of at-risk participants. That is, the at-risk count includes those randomized to the Amifampridine Phosphate-Placebo sequence, Placebo - Amifampridine Phosphate sequence and those that received Amifampridine Phosphate during the open-label Run-in period but were not randomized for the crossover portion of the study."
11320465|NCT03304054|EG001|Reported Event|Placebo|"Placebo Oral Tablet: tablets matching amifampridine phosphate, 3 to 4 times a day~The AEs reported within this treatment arm are those experienced by participants who received Placebo at the time of onset of the AE. This includes those randomized to the Placebo - Amifampridine Phosphate sequence."
11320466|NCT03304054|EG002|Reported Event|Overall|Includes all participants who received study drug, including Amifampridine Phosphate during the open-label Run-in period or double-blind treatment period or Placebo during the double-blind treatment period.
11320467|NCT03304106|BG000|Baseline|Group 1|Newly implanted recipients
11320468|NCT03304106|BG001|Baseline|Group 2|Existing recipients
11320469|NCT03304106|BG002|Baseline|Total|Total of all reporting groups
11320470|NCT03304106|FG000|Participant Flow|Newly Implanted CI Recipients|Newly implanted recipients
11320471|NCT03304106|FG001|Participant Flow|Existing CI Recipients|Existing recipients
11320472|NCT03304106|OG000|Outcome|Group 1|Newly implanted recipients
11320473|NCT03304106|OG001|Outcome|Group 2|Existing recipients
11320474|NCT03304106|EG000|Reported Event|Group 1|Newly implanted recipients
11320475|NCT03304106|EG001|Reported Event|Group 2|Existing recipients
11320476|NCT03304119|BG000|Baseline|Patellar Instability Group|Group of patients with patellar instability stemming from a recurrent patellar dislocation
11320477|NCT03304119|BG001|Baseline|Control Group Control|Group that has not been checked for patellar instability.
11320478|NCT03304119|BG002|Baseline|Total|Total of all reporting groups
11320479|NCT03304119|FG000|Participant Flow|Patellar Instability Group|Group of patients with patellar instability stemming from a recurrent patellar dislocation
11320480|NCT03304119|FG001|Participant Flow|Control Group Control|Group that has not been checked for patellar instability.
11320481|NCT03304119|OG000|Outcome|Patellar Instability Group|Group of patients with patellar instability stemming from a recurrent patellar dislocation
11320482|NCT03304119|OG001|Outcome|Control Group Control|Group that has not been checked for patellar instability.
11320483|NCT03304119|EG000|Reported Event|Patellar Instability Group|Group of patients with patellar instability stemming from a recurrent patellar dislocation
11320484|NCT03304119|EG001|Reported Event|Control Group Control|Group that has not been checked for patellar instability.
11320485|NCT03304184|BG000|Baseline|Photac-fil|"Participants will have a restoration placed with photac-fil in the lesion near the gum line.~Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion."
11320486|NCT03304184|BG001|Baseline|Biodentine|"Participants will have a restoration placed with Biodentine in the lesion near the gum line.~Biodentine: Application of a white colored filling in a non-cavitated dental lesion."
11320487|NCT03304184|BG002|Baseline|Total|Total of all reporting groups
11320488|NCT03304184|FG000|Participant Flow|Photac-fil|"Participants will have a restoration placed with photac-fil in the lesion near the gum line.~Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion."
11320489|NCT03304184|FG001|Participant Flow|Biodentine|"Participants will have a restoration placed with Biodentine in the lesion near the gum line.~Biodentine: Application of a white colored filling in a non-cavitated dental lesion."
11320490|NCT03304184|OG000|Outcome|Photac-fil|"Participants will have a restoration placed with photac-fil in the lesion near the gum line.~Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion."
11320491|NCT03304184|OG001|Outcome|Biodentine|"Participants will have a restoration placed with Biodentine in the lesion near the gum line.~Biodentine: Application of a white colored filling in a non-cavitated dental lesion."
11320492|NCT03304184|OG000|Outcome|Photac|"Participants will have a restoration placed with photac-fil in the lesion near the gum line.~Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion."
11320493|NCT03304184|EG000|Reported Event|Photac-fil|"Participants will have a restoration placed with photac-fil in the lesion near the gum line.~Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion."
11320494|NCT03304184|EG001|Reported Event|Biodentine|"Participants will have a restoration placed with Biodentine in the lesion near the gum line.~Biodentine: Application of a white colored filling in a non-cavitated dental lesion."
11320495|NCT03304522|BG000|Baseline|VX-150|Participants received VX-150 1250 mg qd for 6 weeks.
11320496|NCT03304522|BG001|Baseline|Placebo|Participants received placebo matched to VX-150 for 6 weeks.
11320497|NCT03304522|BG002|Baseline|Total|Total of all reporting groups
11320498|NCT03304522|FG000|Participant Flow|VX-150|Participants received VX-150 1250 milligram (mg) once daily (qd) for 6 weeks.
11320499|NCT03304522|FG001|Participant Flow|Placebo|Participants received placebo matched to VX-150 for 6 weeks.
11320500|NCT03304522|OG000|Outcome|VX-150|Participants received VX-150 1250 mg qd for 6 weeks.
11320501|NCT03304522|OG001|Outcome|Placebo|Participants received placebo matched to VX-150 for 6 weeks.
11320502|NCT03304522|EG000|Reported Event|VX-150|Participants received VX-150 1250 mg qd for 6 weeks.
11320503|NCT03304522|EG001|Reported Event|Placebo|Participants received placebo matched to VX-150 for 6 weeks.
11320504|NCT03304626|BG000|Baseline|Study Group|"Budesonide EC 3 mg capsule. The dose will be as follows~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS1~Budesonide 3Mg Capsule: Budesonide capsule in place of prednisone (standard of care)"
11320505|NCT03304626|BG001|Baseline|Control Group|Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Prednisone 15-60 mg Days 31-45 SIS + Prednisone 10 mg Days 46-90 SIS + Prednisone 2.5 to 7.5 mg Days 90 onwards SIS
11320506|NCT03304626|BG002|Baseline|Total|Total of all reporting groups
11320507|NCT03304626|FG000|Participant Flow|Study Group|"Budesonide EC 3 mg capsule. The dose will be as follows~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS1~Budesonide 3Mg Capsule: Budesonide capsule in place of prednisone (standard of care)"
11320508|NCT03304626|FG001|Participant Flow|Control Group|"Standard of Care Controls that received~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Prednisone 15-60 mg Days 31-45 SIS + Prednisone 10 mg Days 46-90 SIS + Prednisone 2.5 to 7.5 mg Days 90 onwards SIS"
11320509|NCT03304626|OG000|Outcome|Study Group|"Budesonide EC 3 mg capsule. The dose will be as follows~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS1~Budesonide 3Mg Capsule: Budesonide capsule in place of prednisone (standard of care)"
11320510|NCT03304626|OG001|Outcome|Control Group|"Standard of Care~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Prednisone 15-60 mg Days 31-45 SIS + Prednisone 10 mg Days 46-90 SIS + Prednisone 2.5 to 7.5 mg Days 90 onwards SIS~Standard of Care Prednisone: Prednisone taper (Standard of Care)"
11320511|NCT03304626|OG001|Outcome|Control Group|"Standard of Care Controls that received~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Prednisone 15-60 mg Days 31-45 SIS + Prednisone 10 mg Days 46-90 SIS + Prednisone 2.5 to 7.5 mg Days 90 onwards SIS"
11320512|NCT03304626|EG000|Reported Event|Study Group|"Budesonide EC 3 mg capsule. The dose will be as follows~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS1~Budesonide 3Mg Capsule: Budesonide capsule in place of prednisone (standard of care)"
11320513|NCT03304626|EG001|Reported Event|Control Group|"Standard of Care Controls that received~Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Prednisone 15-60 mg Days 31-45 SIS + Prednisone 10 mg Days 46-90 SIS + Prednisone 2.5 to 7.5 mg Days 90 onwards SIS"
11320514|NCT03304873|BG000|Baseline|Retapamulin|"Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.~Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%)."
11320515|NCT03304873|BG001|Baseline|Placebo|"The placebo used will be a triple purified pharmaceutical grade white petrolatum~Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum."
11320516|NCT03304873|BG002|Baseline|Total|Total of all reporting groups
11320517|NCT03304873|FG000|Participant Flow|Retapamulin|"Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.~Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%)."
10827817|NCT00112047|OG000|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
10827818|NCT00112047|OG001|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
10827819|NCT00112047|OG000|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
10827820|NCT00112047|OG000|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
10827821|NCT00112047|OG001|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
10827822|NCT00112047|EG000|Reported Event|FTC+TDF+EFV (Baseline to 144 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.
10827823|NCT00112047|EG001|Reported Event|FTC+TDF+EFV/ATR (Baseline to 240 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.
10827824|NCT00112047|EG002|Reported Event|CBV+EFV (Baseline to 144 Weeks)|Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.
10827825|NCT00112047|EG003|Reported Event|All Atripla (Week 144 to 240)|Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
10827826|NCT00112112|BG000|Baseline|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
10827827|NCT00112112|BG001|Baseline|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
10827828|NCT00112112|BG002|Baseline|Total|Total of all reporting groups
10827829|NCT00112112|FG000|Participant Flow|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
11320518|NCT03304873|FG001|Participant Flow|Placebo|"The placebo used will be a triple purified pharmaceutical grade white petrolatum~Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum."
11320519|NCT03304873|OG000|Outcome|Retapamulin|"Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.~Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%)."
11320520|NCT03304873|OG001|Outcome|Placebo|"The placebo used will be a triple purified pharmaceutical grade white petrolatum~Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum."
11320521|NCT03304873|EG000|Reported Event|Retapamulin|"Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.~Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%)."
11320522|NCT03304873|EG001|Reported Event|Placebo|"The placebo used will be a triple purified pharmaceutical grade white petrolatum~Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum."
11320523|NCT03305081|BG000|Baseline|Immediate or Early Placement|"Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320524|NCT03305081|BG001|Baseline|Interval Placement|"Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320525|NCT03305081|BG002|Baseline|Total|Total of all reporting groups
11320526|NCT03305081|FG000|Participant Flow|Immediate or Early Placement|"Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320527|NCT03305081|FG001|Participant Flow|Interval Placement|"Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320528|NCT03305081|OG000|Outcome|Immediate or Early Placement|"Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320529|NCT03305081|OG001|Outcome|Interval Placement|"Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320530|NCT03305081|EG000|Reported Event|Immediate or Early Placement|"Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320531|NCT03305081|EG001|Reported Event|Interval Placement|"Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant~Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception"
11320532|NCT03305159|BG000|Baseline|Control (Povidone Iodine)|"Patients to receive povidone iodine for the surgical preparation of the vagina.~Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina."
11320533|NCT03305159|BG001|Baseline|Intervention (4% Chlorhexidine Gluconate)|"Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.~4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina."
11320534|NCT03305159|BG002|Baseline|Total|Total of all reporting groups
11320535|NCT03305159|FG000|Participant Flow|Control (Povidone Iodine)|"Patients to receive povidone iodine for the surgical preparation of the vagina.~Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina."
11320536|NCT03305159|FG001|Participant Flow|Intervention (4% Chlorhexidine Gluconate)|"Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.~4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina."
11320537|NCT03305159|OG000|Outcome|Control (Povidone Iodine)|"Patients to receive povidone iodine for the surgical preparation of the vagina.~Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina."
11320538|NCT03305159|OG001|Outcome|Intervention (4% Chlorhexidine Gluconate)|"Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.~4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina."
11320539|NCT03305159|EG000|Reported Event|Control (Povidone Iodine)|"Patients to receive povidone iodine for the surgical preparation of the vagina.~Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina."
11320540|NCT03305159|EG001|Reported Event|Intervention (4% Chlorhexidine Gluconate)|"Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.~4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina."
11320541|NCT03305419|BG000|Baseline|Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID|Participants received oral capsule of 120 mg GSK2982772 three times a day in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320542|NCT03305419|BG001|Baseline|Part A:GSK2982772 120 mg TID/240 mg TID/Placebo|Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320543|NCT03305419|BG002|Baseline|Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID|Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320544|NCT03305419|BG003|Baseline|Part A:Placebo/GSK2982772 240 mg TID/360 mg BID|Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320545|NCT03305419|BG004|Baseline|Part B:Placebo|Participants received matching oral placebo capsule to GSK2928772 for 14 days.
11320546|NCT03305419|BG005|Baseline|Part B:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days
11320547|NCT03305419|BG006|Baseline|Part B:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
11320548|NCT03305419|BG007|Baseline|Part B:GSK2982772 360 mg TID|Participants received GSK2982772 oral capsule at a dose of 360 mg TID for 14 days.
11320549|NCT03305419|BG008|Baseline|Total|Total of all reporting groups
11320550|NCT03305419|FG000|Participant Flow|Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID|Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320551|NCT03305419|FG001|Participant Flow|Part A:GSK2982772 120 mg TID/240 mg TID/Placebo|Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320552|NCT03305419|FG002|Participant Flow|Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID|Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320553|NCT03305419|FG003|Participant Flow|Part A:Placebo/GSK2982772 240 mg TID/360 mg BID|Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.
11320554|NCT03305419|FG004|Participant Flow|Part B:Placebo|Participants received matching oral placebo capsule to GSK2928772 for 14 days.
11320555|NCT03305419|FG005|Participant Flow|Part B:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days
11320556|NCT03305419|FG006|Participant Flow|Part B:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
11320557|NCT03305419|FG007|Participant Flow|Part B:GSK2982772 360 mg BID|Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg BID for 14 days.
11320558|NCT03305419|OG000|Outcome|Part A:Placebo|Participants received matching oral placebo capsule to GSK2928772
11320559|NCT03305419|OG001|Outcome|Part A:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID
11320560|NCT03305419|OG002|Outcome|Part A:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID
11320561|NCT03305419|OG003|Outcome|Part A:GSK2982772 360 mg BID|Participants received GSK2982772 oral capsule at a dose of 360 mg BID
11320562|NCT03305419|OG000|Outcome|Part B:Placebo|Participants received matching oral placebo capsule to GSK2928772 for 14 days
11320563|NCT03305419|OG001|Outcome|Part B:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days
11320564|NCT03305419|OG002|Outcome|Part B:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
11320565|NCT03305419|OG003|Outcome|Part B:GSK2982772 360 mg BID|Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg BID for 14 days
11320566|NCT03305419|OG000|Outcome|Part A:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID
11320567|NCT03305419|OG001|Outcome|Part A:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID
11320568|NCT03305419|OG000|Outcome|Part A:GSK2982772 360 mg BID|Participants received GSK2982772 oral capsule at a dose of 360 mg BID
11320569|NCT03305419|OG000|Outcome|Part B:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days
11320570|NCT03305419|OG001|Outcome|Part B:GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
11320571|NCT03305419|EG000|Reported Event|Part A: Placebo|Participants received matching oral placebo capsule to GSK2928772
11320572|NCT03305419|EG001|Reported Event|Part A:GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID
11320573|NCT03305419|EG002|Reported Event|Part A: GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID
11320574|NCT03305419|EG003|Reported Event|Part A: GSK2982772 360 mg BID|Participants received GSK2982772 oral capsule at a dose of 360 mg BID
11320575|NCT03305419|EG004|Reported Event|Part B:Placebo|Participants received matching oral placebo capsule to GSK2928772 for 14 days.
11320576|NCT03305419|EG005|Reported Event|Part B: GSK2982772 120 mg TID|Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days
11320577|NCT03305419|EG006|Reported Event|Part B: GSK2982772 240 mg TID|Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days
11320578|NCT03305419|EG007|Reported Event|Part B: GSK2982772 360 mg BID|Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg TID for 14 days
11320579|NCT03305575|BG000|Baseline|Chloroprocaine|"Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)~Chloroprocaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.~During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia."
11335969|NCT03559179|EG002|Reported Event|Non-Waivered Providers Who Did Not Receive the Opioid Wizard|"Non-waivered providers were randomized to receive/not receive the Opioid Wizard.~This arm represents the providers who did not receive access to the opioid wizard.These providers continued to treat their patients as usual."
11335970|NCT03559205|BG000|Baseline|MSK-Tracker (Before)|Usual Care in clinic consultations
11320580|NCT03305575|BG001|Baseline|Bupivacaine|"Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).~Bupivacaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.~During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia."
11320581|NCT03305575|BG002|Baseline|Total|Total of all reporting groups
11320582|NCT03305575|FG000|Participant Flow|Chloroprocaine|Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
11320583|NCT03305575|FG001|Participant Flow|Bupivacaine|Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
11320584|NCT03305575|OG000|Outcome|Chloroprocaine|Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
11320585|NCT03305575|OG001|Outcome|Bupivacaine|Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
11320586|NCT03305575|EG000|Reported Event|Chloroprocaine|Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
11320587|NCT03305575|EG001|Reported Event|Bupivacaine|Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
11320588|NCT03305653|BG000|Baseline|Current/Historical Diagnosis of EoE|"Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP~Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins."
11320589|NCT03305653|FG000|Participant Flow|Current/Historical Diagnosis of EoE|"Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP~Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins."
11320590|NCT03305653|OG000|Outcome|Current/Historical Diagnosis of EoE|"Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP~Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins."
11320591|NCT03305653|EG000|Reported Event|Current/Historical Diagnosis of EoE|"Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP~Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins."
11320592|NCT03305666|BG000|Baseline|Bupivacaine Indwelling Catheter|"Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours~Bupivacaine indwelling catheter: Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op"
11320593|NCT03305666|BG001|Baseline|Liposomal Bupivacaine Injection|"A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8).~Liposomal bupivacaine injection: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS"
11320594|NCT03305666|BG002|Baseline|Total|Total of all reporting groups
11320595|NCT03305666|FG000|Participant Flow|Bupivacaine Indwelling Catheter|"Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours~Bupivacaine indwelling catheter: Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op"
11320596|NCT03305666|FG001|Participant Flow|Liposomal Bupivacaine Injection|"A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8).~Liposomal bupivacaine injection: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS"
11320597|NCT03305666|OG000|Outcome|Bupivacaine Indwelling Catheter|"Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours~Bupivacaine indwelling catheter: Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op"
11320598|NCT03305666|OG001|Outcome|Liposomal Bupivacaine Injection|"A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8).~Liposomal bupivacaine injection: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS"
11320599|NCT03305666|EG000|Reported Event|Bupivacaine Indwelling Catheter|"Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours~Bupivacaine indwelling catheter: Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op"
11320600|NCT03305666|EG001|Reported Event|Liposomal Bupivacaine Injection|"A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8).~Liposomal bupivacaine injection: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS"
11320601|NCT03305731|BG000|Baseline|Activating Behavior for Lasting Engagement|"Participants will engage in the ABLE intervention.~Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities."
11320602|NCT03305731|FG000|Participant Flow|Activating Behavior for Lasting Engagement|"Participants will engage in the ABLE intervention.~Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities."
11320603|NCT03305731|OG000|Outcome|Activating Behavior for Lasting Engagement|"Participants will engage in the ABLE intervention.~Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities."
11320604|NCT03305731|EG000|Reported Event|Activating Behavior for Lasting Engagement|"Participants will engage in the ABLE intervention.~Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities."
11320605|NCT03305770|BG000|Baseline|DD T2|Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
11320606|NCT03305770|BG001|Baseline|DT 1|Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
11320607|NCT03305770|BG002|Baseline|Total|Total of all reporting groups
11320608|NCT03305770|FG000|Participant Flow|DD T2|Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
11320609|NCT03305770|FG001|Participant Flow|DT 1|Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
11320610|NCT03305770|OG000|Outcome|DD T2|Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
11320611|NCT03305770|OG001|Outcome|DT 1|Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
11320612|NCT03305770|EG000|Reported Event|DD T2 Ocular|Eyes exposed to verofilcon A contact lenses
11320613|NCT03305770|EG001|Reported Event|DD T2 Non-ocular|Subjects exposed to verofilcon A contact lenses
11320614|NCT03305770|EG002|Reported Event|DT 1 Ocular|Eyes exposed to delefilcon A contact lenses
11320615|NCT03305770|EG003|Reported Event|DT 1 Non-ocular|Subjects exposed to delefilcon A contact lenses
11320616|NCT03305809|BG000|Baseline|Placebo|Participants received placebo administered orally QD.
11320617|NCT03305809|BG001|Baseline|10 mg LY3154207|Participants received 10 mg LY3154207 administered orally QD.
11320618|NCT03305809|BG002|Baseline|30 mg LY3154207|Participants received 30 mg LY3154207 administered orally QD.
11320619|NCT03305809|BG003|Baseline|75 mg LY3154207|Participants received 75 mg LY3154207 administered orally QD.
11320620|NCT03305809|BG004|Baseline|Total|Total of all reporting groups
10827830|NCT00112112|FG001|Participant Flow|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
11320621|NCT03305809|FG000|Participant Flow|Placebo|Participants received placebo administered orally once a day (QD).
11320622|NCT03305809|FG001|Participant Flow|10 Milligram (mg) LY3154207|Participants received 10 mg LY3154207 administered orally QD.
11320623|NCT03305809|FG002|Participant Flow|30 mg LY3154207|Participants received 30 mg LY3154207 administered orally QD.
11320624|NCT03305809|FG003|Participant Flow|75 mg LY3154207|Participants received 75 mg LY3154207 administered orally QD.
11320625|NCT03305809|OG000|Outcome|Placebo|Participants received placebo administered orally QD.
11320626|NCT03305809|OG001|Outcome|10 mg LY3154207|Participants received 10 mg LY3154207 administered orally QD.
11320627|NCT03305809|OG002|Outcome|30 mg LY3154207|Participants received 30 mg LY3154207 administered orally QD.
11320628|NCT03305809|OG003|Outcome|75 mg LY3154207|Participants received 75 mg LY3154207 administered orally QD.
11320629|NCT03305809|OG000|Outcome|10 mg LY3154207|Participants received 10 mg LY3154207 administered orally QD.
11320630|NCT03305809|OG001|Outcome|30 mg LY3154207|Participants received 30 mg LY3154207 administered orally QD.
10827831|NCT00112112|OG000|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
11320631|NCT03305809|OG002|Outcome|75 mg LY3154207|Participants received 75 mg LY3154207 administered orally QD.
11320632|NCT03305809|EG000|Reported Event|Placebo|Participants received placebo administered orally QD.
11320633|NCT03305809|EG001|Reported Event|10 mg LY3154207|Participants received 10 mg LY3154207 administered orally QD.
11320634|NCT03305809|EG002|Reported Event|30 mg LY3154207|Participants received 30 mg LY3154207 administered orally QD.
11320635|NCT03305809|EG003|Reported Event|75 mg LY3154207|Participants received 75 mg LY3154207 administered orally QD.
11320636|NCT03305822|BG000|Baseline|Overall|All participants received LY900014 or 15 U Humalog in a crossover design with an approximately 3 day washout period.
11320637|NCT03305822|FG000|Participant Flow|LY900014/Humalog|Participants receive a single, subcutaneous (SC) dose of LY900014 with a 3 day washout and a single subcutaneous (SC) 15 U dose of Humalog (insulin lispro)
11320638|NCT03305822|FG001|Participant Flow|Humalog/LY900014|Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro) with a 3 day washout and a single subcutaneous (SC) LY900014.
11320639|NCT03305822|OG000|Outcome|LY900014|Participants receive a single, subcutaneous (SC) dose of 15 U LY900014.
11320640|NCT03305822|OG001|Outcome|Humalog|Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro).
11320641|NCT03305822|EG000|Reported Event|15 U LY900014|Participants received a single, subcutaneous (SC) dose 15U LY900014.
11320642|NCT03305822|EG001|Reported Event|Humalog|Participants received a single, subcutaneous (SC) dose 15 U of Humalog (insulin lispro).
11320643|NCT03305887|BG000|Baseline|STRATAFIX Symmetric PDS Plus|an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)
11320644|NCT03305887|BG001|Baseline|Conventional Sutures|Conventional Sutures is VICRYL Plus(Polyglactin 910)
11320645|NCT03305887|BG002|Baseline|Total|Total of all reporting groups
11320646|NCT03305887|FG000|Participant Flow|STRATAFIX Symmetric PDS Plus|an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)
11320647|NCT03305887|FG001|Participant Flow|Conventional Sutures|Conventional Sutures is VICRYL Plus(Polyglactin 910)
11320648|NCT03305887|OG000|Outcome|STRATAFIX Symmetric PDS Plus|an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)
11320649|NCT03305887|OG001|Outcome|Conventional Sutures|Conventional Sutures is VICRYL Plus(Polyglactin 910)
11320650|NCT03305887|EG000|Reported Event|STRATAFIX Symmetric PDS Plus|an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone) total 90 patients had been collected Adverse Events(AE) related data, and 1 patient has no data in this group.
11320651|NCT03305887|EG001|Reported Event|Conventional Sutures|Conventional Sutures is VICRYL Plus (Polyglactin 910) total 89 patients had been collected Adverse Events(AE) related data, and 4 patient has no AE data in Conventional Sutures group.
11320652|NCT03306043|BG000|Baseline|Mepolizumab 300 mg SC|Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).
11320653|NCT03306043|FG000|Participant Flow|Mepolizumab 300 mg SC|Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).
11320654|NCT03306043|OG000|Outcome|Mepolizumab 300 mg SC|Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).
11320655|NCT03306043|EG000|Reported Event|Mepolizumab 300 mg SC|Participants were administered 300 mg SC mepolizumab every 4 weeks (starting approximately 32 weeks after the first dose of study treatment in Study 200622). The final dose of mepolizumab was administered at Visit 5 (Week 16).
11320656|NCT03306199|BG000|Baseline|Turbo Power + DCB|Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
11320657|NCT03306199|FG000|Participant Flow|Turbo Power + DCB|Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
11320658|NCT03306199|OG000|Outcome|Turbo Power + DCB|Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
11320659|NCT03306199|EG000|Reported Event|Turbo Power + DCB|Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
11335971|NCT03559205|BG001|Baseline|MSK-Tracker (After)|"Use of the MSK-Tracker in clinic consultations~MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:~Pre-clinic preparation.~Clinic dashboard.~Summary action plan.~Personal goal setting.~Follow-up and monitoring."
11320660|NCT03306277|BG000|Baseline|Onasemnogene Abeparvovec-xioi|"One-time Intravenous administration of onasemnogene abeparvovec-xioi at the therapeutic dose.~Onasemnogene Abeparvovec-xioi: Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription."
11320661|NCT03306277|FG000|Participant Flow|Onasemnogene Abeparvovec-xioi|"One-time Intravenous administration of onasemnogene abeparvovec-xioi at the therapeutic dose.~Onasemnogene Abeparvovec-xioi: Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription."
11320662|NCT03306277|OG000|Outcome|Onasemnogene Abeparvovec-xioi|"One-time Intravenous administration of onasemnogene abeparvovec-xioi at the therapeutic dose.~Onasemnogene Abeparvovec-xioi: Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription."
11320663|NCT03306277|EG000|Reported Event|Onasemnogene Abeparvovec-xioi|"One-time Intravenous administration of onasemnogene abeparvovec-xioi at the therapeutic dose.~Onasemnogene Abeparvovec-xioi: Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription."
11320664|NCT03306420|BG000|Baseline|Part 1A Dose Escalation: M4112 100 mg|Participants received an oral dose of 100 milligrams (mg) M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320665|NCT03306420|BG001|Baseline|Part 1A Dose Escalation: M4112 200 mg|Participants received an oral dose of 200 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320666|NCT03306420|BG002|Baseline|Part 1A Dose Escalation: M4112 400 mg|Participants received an oral dose of 400 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320667|NCT03306420|BG003|Baseline|Part 1A Dose Escalation: M4112 600 mg|Participants received an oral dose of 600 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320668|NCT03306420|BG004|Baseline|Part 1A Dose Escalation: M4112 800 mg|Participants received an oral dose of 800 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320669|NCT03306420|BG005|Baseline|Total|Total of all reporting groups
11320670|NCT03306420|FG000|Participant Flow|Part 1A Dose Escalation: M4112 100 mg|Participants received an oral dose of 100 milligrams (mg) M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320671|NCT03306420|FG001|Participant Flow|Part 1A Dose Escalation: M4112 200 mg|Participants received an oral dose of 200 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320672|NCT03306420|FG002|Participant Flow|Part 1A Dose Escalation: M4112 400 mg|Participants received an oral dose of 400 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320673|NCT03306420|FG003|Participant Flow|Part 1A Dose Escalation: M4112 600 mg|Participants received an oral dose of 600 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320674|NCT03306420|FG004|Participant Flow|Part 1A Dose Escalation: M4112 800 mg|Participants received an oral dose of 800 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320675|NCT03306420|OG000|Outcome|Part 1A Dose Escalation: M4112 100 mg|Participants received an oral dose of 100 milligrams (mg) M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320676|NCT03306420|OG001|Outcome|Part 1A Dose Escalation: M4112 200 mg|Participants received an oral dose of 200 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320677|NCT03306420|OG002|Outcome|Part 1A Dose Escalation: M4112 400 mg|Participants received an oral dose of 400 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320678|NCT03306420|OG003|Outcome|Part 1A Dose Escalation: M4112 600 mg|Participants received an oral dose of 600 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320679|NCT03306420|OG004|Outcome|Part 1A Dose Escalation: M4112 800 mg|Participants received an oral dose of 800 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11335972|NCT03559205|BG002|Baseline|Total|Total of all reporting groups
11335973|NCT03559205|FG000|Participant Flow|MSK-Tracker (Before)|Usual Care in clinic consultations
11335974|NCT03559205|FG001|Participant Flow|MSK-Tracker (After)|"Use of the MSK-Tracker in clinic consultations~MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:~Pre-clinic preparation.~Clinic dashboard.~Summary action plan.~Personal goal setting.~Follow-up and monitoring."
11335975|NCT03559205|OG000|Outcome|MSK-Tracker (Before)|Usual Care in clinic consultations
11320680|NCT03306420|EG000|Reported Event|Part 1A Dose Escalation: M4112 100 mg|Participants received an oral dose of 100 milligrams (mg) M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320681|NCT03306420|EG001|Reported Event|Part 1A Dose Escalation: M4112 200 mg|Participants received an oral dose of 200 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320682|NCT03306420|EG002|Reported Event|Part 1A Dose Escalation: M4112 400 mg|Participants received an oral dose of 400 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320683|NCT03306420|EG003|Reported Event|Part 1A Dose Escalation: M4112 600 mg|Participants received an oral dose of 600 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320684|NCT03306420|EG004|Reported Event|Part 1A Dose Escalation: M4112 800 mg|Participants received an oral dose of 800 mg M4112 twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
11320685|NCT03306433|BG000|Baseline|All Participants|"Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. All 16 participants had all three treatments. Thus there were 16 participant total. Treatments included:~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.~The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320686|NCT03306433|FG000|Participant Flow|All Participants|"Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. Enrolled participants were assigned to receive up to all three treatments. There were 16 participant total. Treatments included:~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.~The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320687|NCT03306433|OG000|Outcome|UDMA-K18|"UDMA-K18 smooth surface sealant~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320688|NCT03306433|OG001|Outcome|UDMA-control|"UDMA smooth surface sealant without K18~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320689|NCT03306433|OG002|Outcome|Adhesive Control|The adhesive used to bond the orthodontic bracket to the tooth
11320690|NCT03306433|EG000|Reported Event|UDMA-K18|"UDMA-K18 smooth surface sealant~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320691|NCT03306433|EG001|Reported Event|UDMA-control|"UDMA smooth surface sealant without K18~UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface."
11320692|NCT03306433|EG002|Reported Event|Adhesive Control|The adhesive used to bond the orthodontic bracket to the tooth
11320693|NCT03306589|BG000|Baseline|Part 1: LPS 0.5 ng/kg|Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320694|NCT03306589|BG001|Baseline|Part 1: LPS 0.75 ng/kg|Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320695|NCT03306589|BG002|Baseline|Part 1: LPS 1 ng/kg|Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320696|NCT03306589|BG003|Baseline|Part 1: GM-CSF 60 µg/m^2|Participants were randomized to receive 60 microgram per meter square (µg/m^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
11320697|NCT03306589|BG004|Baseline|Part 2: Participants With LPS|Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.
11320698|NCT03306589|BG005|Baseline|Part 2: Participants With GM-CSF|Participants were planned to be dosed with GM-CSF (60 to a maximum of 480 µg/m^2) during Part 2 of the study.
11320699|NCT03306589|BG006|Baseline|Total|Total of all reporting groups
11320700|NCT03306589|FG000|Participant Flow|Part 1: LPS 0.5 ng/kg|Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320701|NCT03306589|FG001|Participant Flow|Part 1: LPS 0.75 ng/kg|Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320702|NCT03306589|FG002|Participant Flow|Part 1: LPS 1 ng/kg|Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320703|NCT03306589|FG003|Participant Flow|Part 1: GM-CSF 60 µg/m^2|Participants were randomized to receive 60 microgram per meter square (µg/m^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
11320704|NCT03306589|FG004|Participant Flow|Part 2: Participants With LPS|Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.
11320705|NCT03306589|FG005|Participant Flow|Part 2: Participants With GM-CSF|Participants were planned to be dosed with GM-CSF (60 to a maximum of 480 µg/m^2) during Part 2 of the study.
11320706|NCT03306589|OG000|Outcome|Part 1: LPS 0.5 ng/kg|Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320707|NCT03306589|OG001|Outcome|Part 1: LPS 0.75 ng/kg|Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320708|NCT03306589|OG002|Outcome|Part 1: LPS 1 ng/kg|Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320709|NCT03306589|OG000|Outcome|Part 2: Participants With LPS|Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.
11320710|NCT03306589|OG000|Outcome|Part 1: GM-CSF 60 µg/m^2|Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
11320711|NCT03306589|OG003|Outcome|Part 1: GM-CSF 60 µg/m^2|Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection
11320712|NCT03306589|OG001|Outcome|Part 2: Participants With GM-CSF|Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.
11320713|NCT03306589|OG000|Outcome|Part 2: Participants With GM-CSF|Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.
11320714|NCT03306589|EG000|Reported Event|Part 1: LPS 0.5 ng/kg|Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320715|NCT03306589|EG001|Reported Event|Part 1: LPS 0.75 ng/kg|Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320716|NCT03306589|EG002|Reported Event|Part 1: LPS 1 ng/kg|Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.
11320717|NCT03306589|EG003|Reported Event|Part 1: GM-CSF 60 µg/m^2|Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection.
11320718|NCT03306589|EG004|Reported Event|Part 2: Participants With LPS|Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study
11320719|NCT03306589|EG005|Reported Event|Part 2: Participants With GM-CSF|Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.
11320720|NCT03306641|BG000|Baseline|Overall Study|"Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week.~Test Contact Lens: Daily disposable contact lens~Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11320721|NCT03306641|FG000|Participant Flow|Test Contact Lens Then Nelfilcon A Lens (Control)|"Per randomized schedule, subject will wear a pair of the test lens for one week and then cross-over with the control pair for 1 week.~Test Contact Lens: Daily disposable contact lens~Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11320722|NCT03306641|FG001|Participant Flow|Nelfilcon A Lens (Control) Then Test Contact Lens|"Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.~Test Contact Lens: Daily disposable contact lens~Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11320723|NCT03306641|OG000|Outcome|Test Contact Lens|"Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study.~Test Contact Lens: Daily disposable contact lens"
11320724|NCT03306641|OG001|Outcome|Nelfilcon A Lens (Control)|"Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study.~Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11320725|NCT03306641|EG000|Reported Event|Test Contact Lens|"Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study.~Test Contact Lens: Daily disposable contact lens"
11320726|NCT03306641|EG001|Reported Event|Nelfilcon A Lens (Control)|"Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study.~Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)"
11320727|NCT03307005|BG000|Baseline|Intervention|Participants received seven nights of zolpidem 5 mg
11320728|NCT03307005|BG001|Baseline|Control|Participants received seven nights of placebo
11320729|NCT03307005|BG002|Baseline|Total|Total of all reporting groups
11320730|NCT03307005|FG000|Participant Flow|Zolpidem Tartrate|Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
11320731|NCT03307005|FG001|Participant Flow|Placebo|Placebo oral capsule: Placebo capsule one per night taken for 7 nights
11320732|NCT03307005|OG000|Outcome|Intervention|Participants received seven nights of zolpidem 5 mg
11320733|NCT03307005|OG001|Outcome|Control|Participants received seven nights of placebo
11320734|NCT03307005|OG000|Outcome|Intervention|Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
11320735|NCT03307005|OG001|Outcome|Control|Placebo oral capsule: Placebo capsule one per night taken for 7 nights
11320736|NCT03307005|EG000|Reported Event|Intervention|Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
11320737|NCT03307005|EG001|Reported Event|Control|Placebo oral capsule: Placebo capsule one per night taken for 7 nights
11335976|NCT03559205|OG001|Outcome|MSK-Tracker (After)|"Use of the MSK-Tracker in clinic consultations~MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:~Pre-clinic preparation.~Clinic dashboard.~Summary action plan.~Personal goal setting.~Follow-up and monitoring."
11335977|NCT03559205|EG000|Reported Event|MSK-Tracker (Before)|Usual Care in clinic consultations
11320738|NCT03307174|BG000|Baseline|Continuous Epidural Infusion|"At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320739|NCT03307174|BG001|Baseline|Programmed Intermittent Epidural Bolus|"For the programmed intermittent epidural bolus group:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320740|NCT03307174|BG002|Baseline|Total|Total of all reporting groups
11320741|NCT03307174|FG000|Participant Flow|Continuous Epidural Infusion|"At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320742|NCT03307174|FG001|Participant Flow|Programmed Intermittent Epidural Bolus|"For the programmed intermittent epidural bolus group:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320743|NCT03307174|OG000|Outcome|Continuous Epidural Infusion|"At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320744|NCT03307174|OG001|Outcome|Programmed Intermittent Epidural Bolus|"For the programmed intermittent epidural bolus group:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320745|NCT03307174|EG000|Reported Event|Continuous Epidural Infusion|"At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320746|NCT03307174|EG001|Reported Event|Programmed Intermittent Epidural Bolus|"For the programmed intermittent epidural bolus group:~Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.~Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.~Bupivacaine~Fentanyl"
11320747|NCT03307252|BG000|Baseline|Cocktail (R1)/ (Verapamil + R1)/ (Rifampin + R1)|In trial part 1 participants were administered a single dose of Cocktail (reference treatment 1, R1) with 280 milliliter (mL) of water in period 1. R1 is a drug cocktail that contains a single dose of each, 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by a single dose of 120 mg Verapamil orally with 240 mL of water at 1 hour (h) prior to R1 which is administered with 280 mL of water in period 2. In period 3 participants were administered a single dose of 600 mg Rifampin film-coated tablet with 280 mL of water together with R1. Treatment periods were separated by a wash-out period of 13 days.
11320748|NCT03307252|BG001|Baseline|(Verapamil + R1)/ (Rifampin + R1)/ R1|In trial part 1 participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 h prior to R1 which is administered with 280 mL of water in period 1. Followed by a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with R1 in period 2. In period 3 participants were administered a single dose of R1 with 280 milliliter (mL) of water. R1 is a drug cocktail that contains a single dose of each, 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Treatment periods were separated by a wash-out period of 13 days.
11320749|NCT03307252|BG002|Baseline|(Rifampin + R1)/ R1/ (Verapamil + R1)|In trial part 1 participants were administered a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with R1 in period 1. Followed by a single dose of R1 with 280 mL of water in period 2. R1 is a drug cocktail that contains a single dose of each, 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. In period 3 participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 hour (h) prior to the R1 which is administered with 280 mL of water. Treatment periods were separated by a wash-out period of 13 days.
11320750|NCT03307252|BG003|Baseline|R1/ Metformin/ (Cimetidine+R1)/ (Cimetidine+Metformin)|In trial part 2 participants were administered single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains a single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 2. Followed by 400 mg Cimetidine 1 orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 3. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to therapeutic dose of 500mg of Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after metformin (Day 2) in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320751|NCT03307252|BG004|Baseline|Metformin/ (Cimetidine+Metformin)/ R1/ (Cimetidine+R1)|In trial part 2 participants were administered single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 1. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after metformin (Day 2) in period 2. Followed by a single dose of R1 with 280 mL of water in period 3. R1 is a drug cocktail that contains single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 400 mg Cimetidine 1 orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320752|NCT03307252|BG005|Baseline|(Cimetidine+R1)/ R1/ (Cimetidine+Metformin)/ Metformin|In trial part 2 participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 1. Followed by single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in period 2. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after Metformin (Day 2) in period 3. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320753|NCT03307252|BG006|Baseline|(Cimetidine+Metformin)/ (Cimetidine+R1)/ Metformin/ R1|In trial part 2 participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after Metformin (Day 2) in period 1. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 2. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 3. Followed by single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320754|NCT03307252|BG007|Baseline|R1/ Furosemide/ (Probenecid + R1)/ (Probenecid + Furosemide)|In trial part 3 participants were administered single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 2. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 3. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320755|NCT03307252|BG008|Baseline|Furosemide/ (Probenecid + Furosemide)/ R1/ (Probenecid + R1)|In trial part 3 participants were administered single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 1. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 2. Followed by single dose of R1 which is administered with 280 milliliter (mL) of water in period 3. R1 is a drug cocktail that contains single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11333911|NCT03521141|BG000|Baseline|Guideline-Based Care (GBC)|"GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11320756|NCT03307252|BG009|Baseline|(Probenecid + R1)/ R1/ (Probenecid + Furosemide)/ Furosemide|In trial part 3 participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 1. Followed by single dose of R1 which is administered with 280 mL of water in period 2. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 3. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320757|NCT03307252|BG010|Baseline|(Probenecid + Furosemide)/ (Probenecid + R1)/ Furosemide/ R1|In trial part 3 participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 1. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 2. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 3. Followed by single dose of R1 which is administered with 280 milliliter (mL) of water in period 4. R1 is a drug cocktail that contains a single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320758|NCT03307252|BG011|Baseline|Total|Total of all reporting groups
11320759|NCT03307252|FG000|Participant Flow|Cocktail (R1)/ (Verapamil + R1)/ (Rifampin + R1)|In trial part 1 participants were administered a single dose of Cocktail (reference treatment 1, R1) with 280 milliliter (mL) of water in period 1. R1 is a drug cocktail that contains a single dose of each, 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by a single dose of 120 mg Verapamil orally with 240 mL of water at 1 hour (h) prior to R1 which is administered with 280 mL of water in period 2. In period 3 participants were administered a single dose of 600 mg Rifampin film-coated tablet with 280 mL of water together with R1. Treatment periods were separated by a wash-out period of 13 days.
11320760|NCT03307252|FG001|Participant Flow|(Verapamil + R1)/ (Rifampin + R1)/ R1|In trial part 1 participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 h prior to R1 which is administered with 280 mL of water in period 1. Followed by a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with R1 in period 2. In period 3 participants were administered a single dose of R1 with 280 milliliter (mL) of water. R1 is a drug cocktail that contains a single dose of each, 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Treatment periods were separated by a wash-out period of 13 days.
11320761|NCT03307252|FG002|Participant Flow|(Rifampin + R1)/ R1/ (Verapamil + R1)|In trial part 1 participants were administered a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with R1 in period 1. Followed by a single dose of R1 with 280 mL of water in period 2. R1 is a drug cocktail that contains a single dose of each, 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. In period 3 participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 hour (h) prior to the R1 which is administered with 280 mL of water. Treatment periods were separated by a wash-out period of 13 days.
11320762|NCT03307252|FG003|Participant Flow|R1/ Metformin/ (Cimetidine+R1)/ (Cimetidine+Metformin)|In trial part 2 participants were administered single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains a single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 2. Followed by 400 mg Cimetidine 1 orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 3. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to therapeutic dose of 500mg of Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after metformin (Day 2) in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320763|NCT03307252|FG004|Participant Flow|Metformin/ (Cimetidine+Metformin)/ R1/ (Cimetidine+R1)|In trial part 2 participants were administered single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 1. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after metformin (Day 2) in period 2. Followed by a single dose of R1 with 280 mL of water in period 3. R1 is a drug cocktail that contains single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 400 mg Cimetidine 1 orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320764|NCT03307252|FG005|Participant Flow|(Cimetidine+R1)/ R1/ (Cimetidine+Metformin)/ Metformin|In trial part 2 participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 1. Followed by single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in period 2. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after Metformin (Day 2) in period 3. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320765|NCT03307252|FG006|Participant Flow|(Cimetidine+Metformin)/ (Cimetidine+R1)/ Metformin/ R1|In trial part 2 participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after Metformin (Day 2) in period 1. Followed by 400 mg Cimetidine 1 tablet orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2) in period 2. Followed by single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in period 3. Followed by single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in period 4. All doses of Cimetidine administered with 240 mL water and R1 and dose of Metformin with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320766|NCT03307252|FG007|Participant Flow|R1/ Furosemide/ (Probenecid + R1)/ (Probenecid + Furosemide)|In trial part 3 participants were administered single dose of R1 which is administered with 280 mL of water in period 1. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 2. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 3. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320767|NCT03307252|FG008|Participant Flow|Furosemide/ (Probenecid + Furosemide)/ R1/ (Probenecid + R1)|In trial part 3 participants were administered single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 1. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 2. Followed by single dose of R1 which is administered with 280 milliliter (mL) of water in period 3. R1 is a drug cocktail that contains single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320768|NCT03307252|FG009|Participant Flow|(Probenecid + R1)/ R1/ (Probenecid + Furosemide)/ Furosemide|In trial part 3 participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 1. Followed by single dose of R1 which is administered with 280 mL of water in period 2. R1 is a drug cocktail that contains single dose of each 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 3. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 4. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320769|NCT03307252|FG010|Participant Flow|(Probenecid + Furosemide)/ (Probenecid + R1)/ Furosemide/ R1|In trial part 3 participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in period 1. Followed by 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 h prior and again 1 h prior to the administration of R1 on day 1 in period 2. Followed by single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in period 3. Followed by single dose of R1 which is administered with 280 milliliter (mL) of water in period 4. R1 is a drug cocktail that contains a single dose of each 0.25 milligram (mg) Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet. All doses of Cimetidine administered with 240 mL water and dose of Furosemide and R1 with 280 mL of water. Treatment periods were separated by a wash-out period of at least 7 days.
11320770|NCT03307252|OG000|Outcome|Verapamil + R1 (T1)|Participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 h prior to the R1 which is administered with 280 mL of water in trial part 1.
11320771|NCT03307252|OG001|Outcome|Cocktail (R1)|Participants were administered a single dose of Cocktail (reference treatment 1, R1) with 280 mL of water. R1 is a drug cocktail that contains a single dose of each, 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in trial part 1, 2 and 3.
11320772|NCT03307252|OG000|Outcome|Rifampin + R1 (T2)|Participants were administered a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with Cocktail in trial part 1.
11320773|NCT03307252|OG000|Outcome|Cimetidine + R1 (T3)|Participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to cocktail and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after cocktail (Day 2). All doses of Cimetidine administered with 240 mL water and dose of Cocktail with 280 mL of water in trial part 2.
11320774|NCT03307252|OG000|Outcome|Probenecid + R1 (T4)|Participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) orally 13 h prior and again 1 h prior to the administration of R1 on day 1. All doses of Cimetidine administered with 240 mL water and dose of R1 which is administered with 280 mL of water in trial part 3.
11320775|NCT03307252|EG000|Reported Event|Cocktail (R1)|Participants were administered a single dose of Cocktail (reference treatment 1, R1) with 280 mL of water. R1 is a drug cocktail that contains a single dose of each, 0.25 mg Digoxin tablet, 1 mg Furosemide oral solution, 10 mg Metformin oral solution and 10 mg Rosuvastatin film-coated tablet in trial part 1, 2 and 3.
10827832|NCT00112112|OG001|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
11320776|NCT03307252|EG001|Reported Event|Verapamil + R1 (T1)|Participants were administered a single dose of 120 mg Verapamil orally with 240 mL of water at 1 h prior to the R1 which is administered with 280 mL of water in trial part 1.
11320777|NCT03307252|EG002|Reported Event|Rifampin + R1 (T2)|Participants were administered a single dose of 600 mg Rifampin film-coated tablet orally with 280 mL of water together with R1 in trial part 1.
11320778|NCT03307252|EG003|Reported Event|Metformin (R2)|Participants were administered a single therapeutic dose of 500 mg Metformin oral solution with 280 mL of water in trial part 2.
11320779|NCT03307252|EG004|Reported Event|Cimetidine + R1 (T3)|Participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to R1 and at 4 h, 8 h, 12 h, 24 h (Day 2) and 36 h after R1 (Day 2). All doses of Cimetidine administered with 240 mL water and dose of R1 which is administered with 280 mL of water in trial part 2.
11320780|NCT03307252|EG005|Reported Event|Cimetidine + R2 (T5)|Participants were administered 400 mg Cimetidine 1 tablet orally at 1 h prior to Metformin and at 4 h, 8 h, 12, 24 h (Day 2) and 36 h after therapeutic dose of 500 mg Metformin (Day 2) in trial part 2.
11320781|NCT03307252|EG006|Reported Event|Furosemide (R3)|Participants were administered orally a single therapeutic dose of 40 mg Furosemide oral solution with 280 mL of water in trial part 3.
11320782|NCT03307252|EG007|Reported Event|Probenecid + R1 (T4)|Participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) orally 13 h prior and again 1 h prior to the administration of R1 on day 1. All doses of Cimetidine administered with 240 mL water and dose of R1 which is administered with 280 mL of water in trial part 3.
11320783|NCT03307252|EG008|Reported Event|Probenecid + R3 (T6)|Participants were administered 2 tablets of 500 mg Probenecid (2*500 mg) administered orally 13 hours prior and again 1 h prior to the administration of Furosemide on Day 1 in trial part 3.
11320784|NCT03307837|BG000|Baseline|CA-008 Cohort 1 0.5 mg|CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.
11320785|NCT03307837|BG001|Baseline|CA-008 Cohort 2 1 mg|CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.
11320786|NCT03307837|BG002|Baseline|CA-008 Cohort 3 2 mg|CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.
11320787|NCT03307837|BG003|Baseline|CA-008 Cohort 4 3 mg|CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.
11320788|NCT03307837|BG004|Baseline|CA-008 Cohort 5 4.2 mg|CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.
11320789|NCT03307837|BG005|Baseline|CA-008 Placebo|CA-008 Placebo: Placebo product
11320790|NCT03307837|BG006|Baseline|Total|Total of all reporting groups
11320791|NCT03307837|FG000|Participant Flow|CA-008 Cohort 1 0.5 mg|Active (CA-008) to Placebo
11320792|NCT03307837|FG001|Participant Flow|CA-008 Cohort 2 1 mg|Active (CA-008) to Placebo
11320793|NCT03307837|FG002|Participant Flow|CA-008 Cohort 3 2 mg|Active (CA-008) to Placebo
11320794|NCT03307837|FG003|Participant Flow|CA-008 Cohort 4 3 mg|Active (CA-008) to Placebo
11320795|NCT03307837|FG004|Participant Flow|CA-008 Cohort 5 4.2 mg|Active (CA-008) to Placebo
11320796|NCT03307837|FG005|Participant Flow|Placebo|Placebo
11320797|NCT03307837|OG000|Outcome|Cohort 1|CA-008 in 0.5 mg dose
11320798|NCT03307837|OG001|Outcome|Cohort 2|CA-008 in 1 mg dose
11320799|NCT03307837|OG002|Outcome|Cohort 3|CA-008 in 2 mg dose
11320800|NCT03307837|OG003|Outcome|Cohort 4|CA-008 in 3 mg dose
11320801|NCT03307837|OG004|Outcome|Cohort 5|CA-008 in 4.2 mg dose
11320802|NCT03307837|OG005|Outcome|Placebo|Placebo administration
11320803|NCT03307837|OG000|Outcome|Cohort 1|CA-008 in doses of 0.5 mg
11320804|NCT03307837|OG001|Outcome|Cohort 2|CA-008 in doses of 1 mg
11320805|NCT03307837|OG002|Outcome|Cohort 3|CA-008 in doses of 2 mg
11320806|NCT03307837|OG003|Outcome|Cohort 4|CA-008 in doses of 3 mg
11320807|NCT03307837|OG004|Outcome|Cohort 5|CA-008 in doses of 4.2 mg
11320808|NCT03307837|EG000|Reported Event|CA-008 Cohort 1|CA-008 in 0.5 mg
11320809|NCT03307837|EG001|Reported Event|CA-008 Cohort 2|CA-008 in 1 mg
11320810|NCT03307837|EG002|Reported Event|CA-008 Cohort 3|CA-008 in 2 mg
11320811|NCT03307837|EG003|Reported Event|CA-008 Cohort 4|CA-008 in 3 mg
11320812|NCT03307837|EG004|Reported Event|CA-008 Cohort 5|CA-008 in 4.2 mg
11320813|NCT03307837|EG005|Reported Event|Placebo|Placebo administration
11320814|NCT03308058|BG000|Baseline|Breastfeeding Computer Education|"Breastfeeding Computer education~Breastfeeding computer education: Breastfeeding computer education"
11320815|NCT03308058|BG001|Baseline|Printed Educational Material|Printed educational material
11320816|NCT03308058|BG002|Baseline|Total|Total of all reporting groups
11320817|NCT03308058|FG000|Participant Flow|Computer Based Breast-feeding Education Group|This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program
11320818|NCT03308058|FG001|Participant Flow|Control Group|This group received the booklet format of the breast feeding educational support program
11320819|NCT03308058|OG000|Outcome|Computer Based Breast-feeding Education Group|This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program
11320820|NCT03308058|OG001|Outcome|Control Group|This group received the booklet format of the breast feeding educational support program
11320821|NCT03308058|EG000|Reported Event|Computer Based Breast-feeding Education Group|This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program
11320822|NCT03308058|EG001|Reported Event|Control Group|This group received the booklet format of the breast feeding educational support program
11320823|NCT03308097|BG000|Baseline|PrEP Mobile Messaging Intervention|"Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.~PrEP Mobile Messaging Intervention: See group description"
11320824|NCT03308097|BG001|Baseline|Enhanced Standard of Care|"As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.~Enhanced Standard of Care: See group description"
11320825|NCT03308097|BG002|Baseline|Total|Total of all reporting groups
11320826|NCT03308097|FG000|Participant Flow|PrEP Mobile Messaging Intervention|"Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.~PrEP Mobile Messaging Intervention: See group description"
11320827|NCT03308097|FG001|Participant Flow|Enhanced Standard of Care|"As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.~Enhanced Standard of Care: See group description"
11320828|NCT03308097|OG000|Outcome|PrEP Mobile Messaging Intervention|"Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.~PrEP Mobile Messaging Intervention: See group description"
11320829|NCT03308097|OG001|Outcome|Enhanced Standard of Care|"As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.~Enhanced Standard of Care: See group description"
11320830|NCT03308097|EG000|Reported Event|PrEP Mobile Messaging Intervention|"Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.~PrEP Mobile Messaging Intervention: See group description"
11320831|NCT03308097|EG001|Reported Event|Enhanced Standard of Care|"As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.~Enhanced Standard of Care: See group description"
11320832|NCT03308669|BG000|Baseline|Treatment Sequence 1: 50 mg Topiramate + Placebo|"Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14.~Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13."
11320833|NCT03308669|BG001|Baseline|Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan|"200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14.~Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13."
11320834|NCT03308669|BG002|Baseline|Total|Total of all reporting groups
11320835|NCT03308669|FG000|Participant Flow|Treatment Sequence 1: 50 mg Topiramate + Placebo|"Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14.~25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13.~Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of placebo."
11320836|NCT03308669|FG001|Participant Flow|Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan|"200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14.~25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13.~Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of lasmiditan."
11320837|NCT03308669|OG000|Outcome|Placebo|Placebo administered orally, alone
11320838|NCT03308669|OG001|Outcome|200 mg Lasmiditan|Lasmiditan administered orally, alone
11320839|NCT03308669|OG002|Outcome|Topiramate Alone|Topiramate administered orally, alone
11320840|NCT03308669|OG003|Outcome|50 mg Topiramate + 200 mg Lasmiditan|Topiramate administered orally, alone, and co-administered with oral lasmiditan
11320841|NCT03308669|OG004|Outcome|50 mg Topiramate + Placebo|Topiramate administered orally, alone, and co-administered with oral placebo
11320842|NCT03308669|OG000|Outcome|50 mg Topiramate|50 mg topiramate administered orally twice-daily on Day 13.
11320843|NCT03308669|OG001|Outcome|50 mg Topiramate + 200 mg Lasmiditan|50 mg topiramate administered twice-daily Day 14. Single oral Dose of 200 mg lasmiditan on Day 14.
11320844|NCT03308669|OG000|Outcome|200 mg Lasmiditan|Single Oral Dose of 200 mg lasmiditan alone on Day 1.
11320845|NCT03308669|OG001|Outcome|50 mg Topiramate + 200 mg Lasmiditan|Single oral dose of 200 mg lasmiditan administered on Day 14. 50 mg topiramate administered orally twice-daily on Day 14.
11320846|NCT03308669|OG000|Outcome|200 mg Lasmiditan|Single Oral Dose of 200 mg lasmiditan on Day 1.
11320847|NCT03308669|OG001|Outcome|50 mg Topiramate + 200 mg Lasmiditan|Single oral Dose of 200 mg lasmiditan on Day 14. 50 mg topiramate administered twice-daily Day 14.
11320848|NCT03308669|EG000|Reported Event|200 mg Lasmiditan|Lasmiditan administered orally, alone
11320849|NCT03308669|EG001|Reported Event|Placebo|Placebo administered orally, alone
11320850|NCT03308669|EG002|Reported Event|Topiramate Alone|Topiramate administered orally, alone
11320851|NCT03308669|EG003|Reported Event|50 mg Topiramate + 200 mg Lasmiditan|Topiramate administered orally, alone, and co-administered with oral lasmiditan
11320852|NCT03308669|EG004|Reported Event|50 mg Topiramate + Placebo|Topiramate administered orally, alone, and co-administered with oral placebo
11320853|NCT03308799|BG000|Baseline|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream"
11320854|NCT03308799|BG001|Baseline|CAL/BDP Combination|"CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.~CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%"
11320855|NCT03308799|BG002|Baseline|Vehicle|"One application daily for 8 weeks.~Vehicle"
11320856|NCT03308799|BG003|Baseline|Total|Total of all reporting groups
11320857|NCT03308799|FG000|Participant Flow|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream"
11320858|NCT03308799|FG001|Participant Flow|CAL/BDP Combination|"CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.~CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%"
11320859|NCT03308799|FG002|Participant Flow|Vehicle|"One application daily for 8 weeks.~Vehicle"
11320860|NCT03308799|OG000|Outcome|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream"
11320861|NCT03308799|OG001|Outcome|CAL/BDP Combination|"CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.~CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%"
11320862|NCT03308799|OG002|Outcome|Vehicle|"One application daily for 8 weeks.~Vehicle"
11320863|NCT03308799|EG000|Reported Event|MC2-01 Cream|"MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks~MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream"
11320864|NCT03308799|EG001|Reported Event|CAL/BDP Combination|"CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.~CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%"
11320865|NCT03308799|EG002|Reported Event|Vehicle|"One application daily for 8 weeks.~Vehicle"
11320866|NCT03308942|BG000|Baseline|Stage 1 (Cohort 1): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.
11320867|NCT03308942|BG001|Baseline|Stage 1 (Cohort 2): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.
11320868|NCT03308942|BG002|Baseline|Stage 1 (Cohort 3): Niraparib|Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.
11320869|NCT03308942|BG003|Baseline|Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
11320870|NCT03308942|BG004|Baseline|Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
11320871|NCT03308942|BG005|Baseline|Total|Total of all reporting groups
11320872|NCT03308942|FG000|Participant Flow|Stage 1 (Cohort 1): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.
11320873|NCT03308942|FG001|Participant Flow|Stage 1 (Cohort 2): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.
11320874|NCT03308942|FG002|Participant Flow|Stage 1 (Cohort 3): Niraparib|Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.
11320875|NCT03308942|FG003|Participant Flow|Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
11320876|NCT03308942|FG004|Participant Flow|Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
11320877|NCT03308942|OG000|Outcome|Stage 1 (Cohort 1): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.
11320878|NCT03308942|OG000|Outcome|Stage 1 (Cohort 2): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.
11320879|NCT03308942|OG000|Outcome|Stage 1 (Cohort 3): Niraparib|Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.
11320880|NCT03308942|OG000|Outcome|Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
11320881|NCT03308942|OG001|Outcome|Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
11320882|NCT03308942|OG001|Outcome|Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
11320883|NCT03308942|EG000|Reported Event|Stage 1 (Cohort 1): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.
11320884|NCT03308942|EG001|Reported Event|Stage 1 (Cohort 2): Niraparib + Pembrolizumab|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle.
11320885|NCT03308942|EG002|Reported Event|Stage 1 (Cohort 3): Niraparib|Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle.
11335978|NCT03559205|EG001|Reported Event|MSK-Tracker (After)|"Use of the MSK-Tracker in clinic consultations~MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:~Pre-clinic preparation.~Clinic dashboard.~Summary action plan.~Personal goal setting.~Follow-up and monitoring."
11335979|NCT03559218|BG000|Baseline|Standard of Care|"Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care~Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis"
11320886|NCT03308942|EG003|Reported Event|Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days).
11320887|NCT03308942|EG004|Reported Event|Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)|Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days).
11320888|NCT03308968|BG000|Baseline|Placebo|DB period: Participants with CM or EM received 3 injections of placebo 1.5 mL SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. OL period: Participants with CM or EM received fremanezumab (TEV-48125) 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320889|NCT03308968|BG001|Baseline|Fremanezumab Quarterly|DB period: Participants with CM or EM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320890|NCT03308968|BG002|Baseline|Fremanezumab Monthly|DB period: Participants with CM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320891|NCT03308968|BG003|Baseline|Total|Total of all reporting groups
11320892|NCT03308968|FG000|Participant Flow|Placebo|Double-blind (DB) period: Participants with chronic migraine (CM) or episodic migraine (EM) received 3 injections of placebo 1.5 milliliters (mL) subcutaneously (SC) on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM received fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320893|NCT03308968|FG001|Participant Flow|Fremanezumab Quarterly|DB period: Participants with CM or EM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320894|NCT03308968|FG002|Participant Flow|Fremanezumab Monthly|DB period: Participants with CM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56).OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320895|NCT03308968|OG000|Outcome|Placebo|DB period: Participants with CM or EM received 3 injections of placebo 1.5 mL SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56.
11320896|NCT03308968|OG001|Outcome|Fremanezumab Quarterly|DB period: Participants with CM or EM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56).
11320897|NCT03308968|OG002|Outcome|Fremanezumab Monthly|DB period: Participants with CM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56).
11320898|NCT03308968|OG000|Outcome|Placebo|OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320899|NCT03308968|OG001|Outcome|Fremanezumab Quarterly|OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320900|NCT03308968|OG002|Outcome|Fremanezumab Monthly|OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320901|NCT03308968|EG000|Reported Event|Placebo|DB period: Participants with CM or EM received 3 injections of placebo 1.5 mL SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. OL period: Participants with CM or EM received fremanezumab (TEV-48125) 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320902|NCT03308968|EG001|Reported Event|Fremanezumab Quarterly|DB period: Participants with CM or EM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11335980|NCT03559218|BG001|Baseline|KeraStat Cream|"Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.~KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin."
11335981|NCT03559218|BG002|Baseline|Total|Total of all reporting groups
11320903|NCT03308968|EG002|Reported Event|Fremanezumab Monthly|DB period: Participants with CM received fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56).OL period: Participants with CM or EM received fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
11320904|NCT03309020|BG000|Baseline|Control|"Control with clinical need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320905|NCT03309020|BG001|Baseline|EVD Survivors|"EVD survivors with need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320906|NCT03309020|BG002|Baseline|Total|Total of all reporting groups
11320907|NCT03309020|FG000|Participant Flow|Control|"Control with clinical need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320908|NCT03309020|FG001|Participant Flow|EVD Survivors|"EVD survivors with need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320909|NCT03309020|OG000|Outcome|EVD Survivors|"EVD survivors with need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320910|NCT03309020|OG000|Outcome|Control|"Control with clinical need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320911|NCT03309020|OG001|Outcome|EVD Survivors|"EVD survivors with need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320912|NCT03309020|OG000|Outcome|All Participants|EVD Survivors and Control Participants
11320913|NCT03309020|EG000|Reported Event|Control|"Control with clinical need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320914|NCT03309020|EG001|Reported Event|EVD Survivors|"EVD survivors with need for cataract surgery~Cataract surgery: Cataract surgery and aqueous humor sampling."
11320915|NCT03309202|BG000|Baseline|Cohort 1 (Without Hepatic Impairment)|Participants in this cohort had no hepatic impairment. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in Clinical Research Unit (CRU) from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320916|NCT03309202|BG001|Baseline|Cohort 2 (Mild Hepatic Impairment)|Participants in this cohort met the criteria of Class A (5 to 6 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320917|NCT03309202|BG002|Baseline|Cohort 3 (Moderate Hepatic Impairment)|Participants in this cohort met the criteria of Class B (7 to 9 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320918|NCT03309202|BG003|Baseline|Cohort 4 (Severe Hepatic Impairment)|Participants in this cohort met the criteria of Class C (10 to 15 points) in Child-Pugh Score. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320919|NCT03309202|BG004|Baseline|Total|Total of all reporting groups
11320920|NCT03309202|FG000|Participant Flow|Cohort 1 (Without Hepatic Impairment)|Participants in this cohort had no hepatic impairment. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in Clinical Research Unit (CRU) from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320921|NCT03309202|FG001|Participant Flow|Cohort 2 (Mild Hepatic Impairment)|Participants in this cohort met the criteria of Class A (5 to 6 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320922|NCT03309202|FG002|Participant Flow|Cohort 3 (Moderate Hepatic Impairment)|Participants in this cohort met the criteria of Class B (7 to 9 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320923|NCT03309202|FG003|Participant Flow|Cohort 4 (Severe Hepatic Impairment)|Participants in this cohort met the criteria of Class C (10 to 15 points) in Child-Pugh Score. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320924|NCT03309202|OG000|Outcome|Cohort 1 (Without Hepatic Impairment)|Participants in this cohort had no hepatic impairment. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in Clinical Research Unit (CRU) from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320925|NCT03309202|OG001|Outcome|Cohort 2 (Mild Hepatic Impairment)|Participants in this cohort met the criteria of Class A (5 to 6 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320926|NCT03309202|OG002|Outcome|Cohort 3 (Moderate Hepatic Impairment)|Participants in this cohort met the criteria of Class B (7 to 9 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
10827833|NCT00112112|EG000|Reported Event|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
11320927|NCT03309202|OG003|Outcome|Cohort 4 (Severe Hepatic Impairment)|Participants in this cohort met the criteria of Class C (10 to 15 points) in Child-Pugh Score. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320928|NCT03309202|EG000|Reported Event|Cohort 1 (Without Hepatic Impairment)|Participants in this cohort had no hepatic impairment. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in Clinical Research Unit (CRU) from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320929|NCT03309202|EG001|Reported Event|Cohort 2 (Mild Hepatic Impairment)|Participants in this cohort met the criteria of Class A (5 to 6 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320930|NCT03309202|EG002|Reported Event|Cohort 3 (Moderate Hepatic Impairment)|Participants in this cohort met the criteria of Class B (7 to 9 points) in Child-Pugh Score.PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320931|NCT03309202|EG003|Reported Event|Cohort 4 (Severe Hepatic Impairment)|Participants in this cohort met the criteria of Class C (10 to 15 points) in Child-Pugh Score. PF-05221304 was administered as a single oral 25 mg dose in fed state on Study Day 1. Participants were hospitalized in CRU from Study Days 1 to 3, and continued inpatient stay or daily outpatient visits to CRU from Days 4 to 7.
11320932|NCT03309449|BG000|Baseline|Intramuscular Administration|"Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin.~Syringe and needle: Intramuscular administration of simulated naloxone"
11320933|NCT03309449|BG001|Baseline|Intranasal (Atomizer)|"Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device.~Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone"
11320934|NCT03309449|BG002|Baseline|Intranasal (Spray)|"Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.~Nasal spray: Nasal spray administration of simulated naloxone"
11320935|NCT03309449|BG003|Baseline|Total|Total of all reporting groups
11320936|NCT03309449|FG000|Participant Flow|Intramuscular Administration|"Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin.~Syringe and needle: Intramuscular administration of simulated naloxone"
11320937|NCT03309449|FG001|Participant Flow|Intranasal (Atomizer)|"Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device.~Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone"
11320938|NCT03309449|FG002|Participant Flow|Intranasal (Spray)|"Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.~Nasal spray: Nasal spray administration of simulated naloxone"
11320939|NCT03309449|OG000|Outcome|Intramuscular Administration|"Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin.~Syringe and needle: Intramuscular administration of simulated naloxone"
11320940|NCT03309449|OG001|Outcome|Intranasal (Atomizer)|"Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device.~Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone"
11320941|NCT03309449|OG002|Outcome|Intranasal (Spray)|"Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.~Nasal spray: Nasal spray administration of simulated naloxone"
11320942|NCT03309449|EG000|Reported Event|Intramuscular Administration|"Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin.~Syringe and needle: Intramuscular administration of simulated naloxone"
11320943|NCT03309449|EG001|Reported Event|Intranasal (Atomizer)|"Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device.~Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone"
11320944|NCT03309449|EG002|Reported Event|Intranasal (Spray)|"Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.~Nasal spray: Nasal spray administration of simulated naloxone"
11320945|NCT03309605|BG000|Baseline|Cohort 1|0.1 mg/kg Concentration 50 mg/mL
11320946|NCT03309605|BG001|Baseline|Cohort 2|0.3 mg/kg Concentration 50 mg/mL
11320947|NCT03309605|BG002|Baseline|Cohort 3|1.0 mg/kg Concentration 100 mg/mL
11320948|NCT03309605|BG003|Baseline|Cohort 4|2.5 mg/kg Concentration 100 mg/mL
11320949|NCT03309605|BG004|Baseline|Cohort 5|1.0 mg/kg Concentration 50 mg/mL
11320950|NCT03309605|BG005|Baseline|Cohort 6|2.5 mg/kg Concentration 50 mg/mL
11320951|NCT03309605|BG006|Baseline|Cohort 7|5.0 mg/kg Concentration 50 mg/mL
11320952|NCT03309605|BG007|Baseline|All Placebo|0 mg/kg
11320953|NCT03309605|BG008|Baseline|Total|Total of all reporting groups
11320954|NCT03309605|FG000|Participant Flow|Cohort 1|0.1 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
11320955|NCT03309605|FG001|Participant Flow|Cohort 2|0.3 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
11320956|NCT03309605|FG002|Participant Flow|Cohort 3|1.0 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
11320957|NCT03309605|FG003|Participant Flow|Cohort 4|2.5 mg/kg Concentration 100 mg/mL, twice a week for 9 doses
11320958|NCT03309605|FG004|Participant Flow|Cohort 5|1.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
11320959|NCT03309605|FG005|Participant Flow|Cohort 6|2.5 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
11320960|NCT03309605|FG006|Participant Flow|Cohort 7|5.0 mg/kg Concentration 50 mg/mL, twice a week for 9 doses
11320961|NCT03309605|FG007|Participant Flow|All Placebo|Placebo, twice a week for 9 doses
11320962|NCT03309605|OG000|Outcome|Cohort 1|0.1 mg/kg, twice a week for 9 doses
11320963|NCT03309605|OG001|Outcome|Cohort 2|0.3 mg/kg, twice a week for 9 doses
11320964|NCT03309605|OG002|Outcome|Cohort 3 and Cohort 5|1.0 mg/kg, twice a week for 9 doses
11320965|NCT03309605|OG003|Outcome|Cohort 4 and Cohort 6|2.5 mg/kg, twice a week for 9 doses
11320966|NCT03309605|OG004|Outcome|Cohort 7|5.0 mg/kg, twice a week for 9 doses
11320967|NCT03309605|OG005|Outcome|All Placebo|Placebo, twice a week for 9 doses
11320968|NCT03309605|EG000|Reported Event|Cohort 1|0.1 mg/kg, twice a week for 9 doses
11320969|NCT03309605|EG001|Reported Event|Cohort 2|0.3 mg/kg, twice a week for 9 doses
11320970|NCT03309605|EG002|Reported Event|Cohort 3 and Cohort 5|1.0 mg/kg, twice a week for 9 doses
11320971|NCT03309605|EG003|Reported Event|Cohort 4 and Cohort 6|2.5 mg/kg, twice a week for 9 doses
11320972|NCT03309605|EG004|Reported Event|Cohort 7|5.0 mg/kg, twice a week for 9 doses
11320973|NCT03309605|EG005|Reported Event|All Placebo|Placebo, twice a week for 9 doses
11320974|NCT03309657|BG000|Baseline|Ceftolozane Tazobactam|"Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.~Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only"
11320975|NCT03309657|FG000|Participant Flow|Ceftolozane Tazobactam|"Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.~Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only"
11320976|NCT03309657|OG000|Outcome|Ceftolozane Tazobactam|"Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.~Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only"
11320977|NCT03309657|EG000|Reported Event|Ceftolozane Tazobactam|"Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.~Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only"
11320978|NCT03309696|BG000|Baseline|tDCS and 1 Hz rTMS Delivered Over TC|Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the temporal cortex.
11320979|NCT03309696|BG001|Baseline|tDCS and 1 Hz rTMS Delivered Over DLPF|Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the dorsolateral frontal cortex.
11320980|NCT03309696|BG002|Baseline|Total|Total of all reporting groups
11320981|NCT03309696|FG000|Participant Flow|tDCS and 1 Hz rTMS Delivered Over TC|"Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .~sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.~sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active~active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active"
11320982|NCT03309696|FG001|Participant Flow|tDCS Over DLFC and 1 Hz rTMS Over TC|"Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.~sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.~sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active~active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active"
11320983|NCT03309696|FG002|Participant Flow|tDCS and 10Hz rTMS Delivered Over TC|"Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.~sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.~sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active~active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active"
11320984|NCT03309696|FG003|Participant Flow|tDCS Over DLFC and 10 Hz rTMS Over TC|"Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.~sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.~sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active~active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active"
11320985|NCT03309696|OG000|Outcome|Sham tDCS Preconditioning|TEPs recorded post sham tDCS but before rTMS.
11320986|NCT03309696|OG001|Outcome|Active tDCS Preconditioning|TEPs recorded after active tDCS preconditioning but before rTMS.
11320987|NCT03309696|OG002|Outcome|Sham tDCS Preconditioning of Sham rTMS|TEPs recorded after sham tDCS preconditioning and sham rTMS.
11320988|NCT03309696|OG003|Outcome|Sham tDCS Preconditioning of Active rTMS|TEPs recorded after sham tDCS preconditioning and active rTMS.
11320989|NCT03309696|OG004|Outcome|Active tDCS Preconditioning of Active rTMS|TEPs recorded after active tDCS preconditioning and active rTMS.
11320990|NCT03309696|EG000|Reported Event|Cumulative Report of Adverse Events|Adverse events data were collected irrespective of Arm/Group assignment. Adverse events were coded as either serious/nonserious, expected/unexpected, and related or unrelated to the intervention. There was only 1 adverse event (a mild headache, which was nonserious, expected and related to active rTMS).
11320991|NCT03309787|BG000|Baseline|Combined Amulet/Fitbit|"As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11320992|NCT03309787|BG001|Baseline|Amulet Only|"As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11320993|NCT03309787|BG002|Baseline|Fitbit Only|"As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11320994|NCT03309787|BG003|Baseline|Total|Total of all reporting groups
11320995|NCT03309787|FG000|Participant Flow|Combined Group (Amulet/Fitbit)|Combined group (Amulet/Fitbit) - Groups were combined because there was not enough data to analyze them separately
11320996|NCT03309787|FG001|Participant Flow|Fitbit Only|Fitbit only as a remote monitoring device (in lieu of Amulet)
11320997|NCT03309787|FG002|Participant Flow|Amulet Only|Amulet only device for remote monitoring
11320998|NCT03309787|OG000|Outcome|Combined Amulet/Fitbit|"As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11320999|NCT03309787|OG001|Outcome|Fitbit Only|videoconferencing + fitbit
11321000|NCT03309787|OG002|Outcome|Amulet Only|videoconferencing + amulet as a remote monitoring device
11321001|NCT03309787|OG000|Outcome|Combined Amulet/Fitbit|"As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321002|NCT03309787|OG001|Outcome|Amulet Only|"As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321003|NCT03309787|OG002|Outcome|Fitbit Only|"As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321004|NCT03309787|OG001|Outcome|Fitbit Only|"As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321005|NCT03309787|OG002|Outcome|Amulet|"As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321006|NCT03309787|OG000|Outcome|Staff Adoption|quantitative scale of staff adoption - 12 questions, each ranging 1-5
11321007|NCT03309787|EG000|Reported Event|Combined Amulet/Fitbit|"As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321008|NCT03309787|EG001|Reported Event|Amulet Only|"As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321009|NCT03309787|EG002|Reported Event|Fitbit Only|"As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.~eHealth: Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring"
11321010|NCT03309943|BG000|Baseline|Propranolol|"Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions~Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions."
11321011|NCT03309943|BG001|Baseline|Placebo|"Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions~Placebo: Participants will take one dose of Placebo on two separate occasions."
11321012|NCT03309943|BG002|Baseline|Total|Total of all reporting groups
11321013|NCT03309943|FG000|Participant Flow|Propranolol|"Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions~Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions."
11321014|NCT03309943|FG001|Participant Flow|Placebo|"Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions~Placebo: Participants will take one dose of Placebo on two separate occasions."
11321015|NCT03309943|OG000|Outcome|Propranolol|"Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions~Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions."
11321016|NCT03309943|OG001|Outcome|Placebo|"Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions~Placebo: Participants will take one dose of Placebo on two separate occasions."
11321017|NCT03309943|EG000|Reported Event|Propranolol|"Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions~Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions."
11321018|NCT03309943|EG001|Reported Event|Placebo|"Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions~Placebo: Participants will take one dose of Placebo on two separate occasions."
11321019|NCT03310021|BG000|Baseline|Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321020|NCT03310021|BG001|Baseline|Cohort 1 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
11321021|NCT03310021|BG002|Baseline|Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321022|NCT03310021|BG003|Baseline|Cohort 2 Rivaroxaban 15 mg BID/Placebo|Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321023|NCT03310021|BG004|Baseline|Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321024|NCT03310021|BG005|Baseline|Cohort 3 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321025|NCT03310021|BG006|Baseline|Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321026|NCT03310021|BG007|Baseline|Cohort 4 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321027|NCT03310021|BG008|Baseline|Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet|400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
11321028|NCT03310021|BG009|Baseline|Cohort 5 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
11321029|NCT03310021|BG010|Baseline|Cohort 6 Apixaban 10 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321030|NCT03310021|BG011|Baseline|Cohort 6 Apixaban 10 mg BID/Placebo|Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321031|NCT03310021|BG012|Baseline|Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321032|NCT03310021|BG013|Baseline|Cohort 7 Edoxaban 30 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321033|NCT03310021|BG014|Baseline|Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321034|NCT03310021|BG015|Baseline|Cohort 8 Apixaban 10 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321035|NCT03310021|BG016|Baseline|Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321036|NCT03310021|BG017|Baseline|Cohort 9 Rivaroxaban 15 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321037|NCT03310021|BG018|Baseline|Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321038|NCT03310021|BG019|Baseline|Cohort 10 Edoxaban 60 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321039|NCT03310021|BG020|Baseline|Total|Total of all reporting groups
11321040|NCT03310021|FG000|Participant Flow|Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321041|NCT03310021|FG001|Participant Flow|Cohort 1 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
11321042|NCT03310021|FG002|Participant Flow|Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321043|NCT03310021|FG003|Participant Flow|Cohort 2 Rivaroxaban 15 mg BID/Placebo|Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321044|NCT03310021|FG004|Participant Flow|Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321045|NCT03310021|FG005|Participant Flow|Cohort 3 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321046|NCT03310021|FG006|Participant Flow|Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321047|NCT03310021|FG007|Participant Flow|Cohort 4 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321048|NCT03310021|FG008|Participant Flow|Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet|400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
11321049|NCT03310021|FG009|Participant Flow|Cohort 5 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
11321050|NCT03310021|FG010|Participant Flow|Cohort 6 Apixaban 10 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321051|NCT03310021|FG011|Participant Flow|Cohort 6 Apixaban 10 mg BID/Placebo|Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321052|NCT03310021|FG012|Participant Flow|Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321053|NCT03310021|FG013|Participant Flow|Cohort 7 Edoxaban 30 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321054|NCT03310021|FG014|Participant Flow|Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321055|NCT03310021|FG015|Participant Flow|Cohort 8 Apixaban 10 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321056|NCT03310021|FG016|Participant Flow|Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321057|NCT03310021|FG017|Participant Flow|Cohort 9 Rivaroxaban 15 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321058|NCT03310021|FG018|Participant Flow|Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321059|NCT03310021|FG019|Participant Flow|Cohort 10 Edoxaban 60 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321060|NCT03310021|OG000|Outcome|Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321061|NCT03310021|OG001|Outcome|Cohort 1 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
11321062|NCT03310021|OG002|Outcome|Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321063|NCT03310021|OG003|Outcome|Cohort 2 Rivaroxaban 15 mg BID/Placebo|Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321064|NCT03310021|OG004|Outcome|Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321065|NCT03310021|OG005|Outcome|Cohort 3 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321066|NCT03310021|OG006|Outcome|Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321067|NCT03310021|OG007|Outcome|Cohort 4 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321068|NCT03310021|OG008|Outcome|Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet|400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
11321069|NCT03310021|OG009|Outcome|Cohort 5 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
11321070|NCT03310021|OG010|Outcome|Cohort 6 Apixaban 10 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321071|NCT03310021|OG011|Outcome|Cohort 6 Apixaban 10 mg BID/Placebo|Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321072|NCT03310021|OG012|Outcome|Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321073|NCT03310021|OG013|Outcome|Cohort 7 Edoxaban 30 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321074|NCT03310021|OG014|Outcome|Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321075|NCT03310021|OG015|Outcome|Cohort 8 Apixaban 10 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321076|NCT03310021|OG016|Outcome|Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321077|NCT03310021|OG017|Outcome|Cohort 9 Rivaroxaban 15 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321078|NCT03310021|OG018|Outcome|Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321079|NCT03310021|OG019|Outcome|Cohort 10 Edoxaban 60 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321080|NCT03310021|EG000|Reported Event|Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321081|NCT03310021|EG001|Reported Event|Cohort 1 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
11321082|NCT03310021|EG002|Reported Event|Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321083|NCT03310021|EG003|Reported Event|Cohort 2 Rivaroxaban 15 mg BID/Placebo|Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
11321084|NCT03310021|EG004|Reported Event|Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321085|NCT03310021|EG005|Reported Event|Cohort 3 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
11321086|NCT03310021|EG006|Reported Event|Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321087|NCT03310021|EG007|Reported Event|Cohort 4 Edooxaban 60 mg QD/Placebo|Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321088|NCT03310021|EG008|Reported Event|Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet|400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
11321089|NCT03310021|EG009|Reported Event|Cohort 5 Apixaban 5 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
11321090|NCT03310021|EG010|Reported Event|Cohort 6 Apixaban 10 mg BID/High Dose Andexanet|Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321091|NCT03310021|EG011|Reported Event|Cohort 6 Apixaban 10 mg BID/Placebo|Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
11321092|NCT03310021|EG012|Reported Event|Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321093|NCT03310021|EG013|Reported Event|Cohort 7 Edoxaban 30 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
11321094|NCT03310021|EG014|Reported Event|Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321095|NCT03310021|EG015|Reported Event|Cohort 8 Apixaban 10 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
11321096|NCT03310021|EG016|Reported Event|Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321097|NCT03310021|EG017|Reported Event|Cohort 9 Rivaroxaban 15 mg BID/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
11321098|NCT03310021|EG018|Reported Event|Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet|Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321099|NCT03310021|EG019|Reported Event|Cohort 10 Edoxaban 60 mg QD/Placebo|Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
11321100|NCT03310268|BG000|Baseline|Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321101|NCT03310268|BG001|Baseline|Negative Control (1400 Ppm Fluoride as SMFP)|Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321102|NCT03310268|BG002|Baseline|Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321103|NCT03310268|BG003|Baseline|Total|Total of all reporting groups
11321104|NCT03310268|FG000|Participant Flow|Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer experimental dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321105|NCT03310268|FG001|Participant Flow|Negative Control (1400 Ppm Fluoride as SMFP)|Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as sodium monofluorophosphate (SMFP)which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321106|NCT03310268|FG002|Participant Flow|Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer positive control dentifrice containing stannous chloride (SnCl2) and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321107|NCT03310268|OG000|Outcome|Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321108|NCT03310268|OG001|Outcome|Negative Control (1400 Ppm Fluoride as SMFP)|Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321109|NCT03310268|OG002|Outcome|Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321110|NCT03310268|EG000|Reported Event|Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321111|NCT03310268|EG001|Reported Event|Negative Control (1400 Ppm Fluoride as SMFP)|Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321112|NCT03310268|EG002|Reported Event|Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])|Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
11321113|NCT03310411|BG000|Baseline|Overall|Participants received single oral dose of 200 mg lasmiditan, 100 mg sumatriptan, 200 mg lasmiditan + 100 mg sumatriptan or placebo tablets on Day 1 of each treatment period according to their assigned treatment sequence.
11321114|NCT03310411|FG000|Participant Flow|Sequence 1|"Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.~Period 1: 200 mg Lasmiditan + 100 mg sumatriptan, Period 2: 200 mg Lasmiditan + placebo Period 3: 100 mg Sumatriptan + placebo Period 4: Placebo + placebo"
11321115|NCT03310411|FG001|Participant Flow|Sequence 2|"Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.~Period 1: 200 mg Lasmiditan + placebo Period 2: 100 mg Sumatriptan + placebo Period 3: Placebo + placebo Period 4: 200 mg Lasmiditan + 100 mg sumatriptan"
11321116|NCT03310411|FG002|Participant Flow|Sequence 3|"Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.~Period 1: 100 mg Sumatriptan + placebo Period 2: Placebo + placebo Period 3: 200 mg Lasmiditan + 100 mg sumatriptan Period 4: 200 mg Lasmiditan + placebo"
11321117|NCT03310411|FG003|Participant Flow|Sequence 4|"Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.~Period 1: Placebo + placebo Period 2: 200 mg Lasmiditan + 100 mg sumatriptan Period 3: 200 mg Lasmiditan + placebo Period 4: 100 mg Sumatriptan + placebo"
11321118|NCT03310411|OG000|Outcome|200 mg Lasmiditan + 100 mg Sumatriptan (A):|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg Sumatriptan tablet on day1.
11321119|NCT03310411|OG001|Outcome|200 mg Lasmiditan + Placebo (B)|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
11321120|NCT03310411|OG002|Outcome|100 mg Sumatriptan + Placebo (C)|Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
11321121|NCT03310411|OG003|Outcome|Placebo + Placebo (D)|Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
11321122|NCT03310411|OG000|Outcome|200 mg Lasmiditan + 100 mg Sumatriptan (A):Analyte: Lasmiditan|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1.
11321123|NCT03310411|OG001|Outcome|200 mg Lasmiditan + Placebo (B): Analyte: Lasmiditan|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
11321124|NCT03310411|OG002|Outcome|200 mg Lasmiditan +100 mg Sumatriptan (A):Analyte: Sumatriptan|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1.
11321125|NCT03310411|OG003|Outcome|100 mg Sumatriptan + Placebo (C): Analyte: Sumatriptan|Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
11321126|NCT03310411|OG000|Outcome|200mg Lasmiditan + 100mg Sumatriptan (A): Analyte: Lasmiditan|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1.
11321127|NCT03310411|OG003|Outcome|100 mg Sumatriptan + Placebo (C): Analyte: Sumatriptan|Participants received single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
11321128|NCT03310411|EG000|Reported Event|200 mg Lasmiditan + 100 mg Sumatriptan (A)|Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1.
11321129|NCT03310411|EG001|Reported Event|200 mg Lasmiditan + Placebo (B)|Participants received single oral dose of 200mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
11321130|NCT03310411|EG002|Reported Event|100 mg Sumatriptan + Placebo (C)|Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
11321131|NCT03310411|EG003|Reported Event|Placebo + Placebo (D)|Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
11321132|NCT03310450|BG000|Baseline|Group 140kms Cycling|"willing to participate in 140kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321133|NCT03310450|BG001|Baseline|Group 100kms Cycling|"willing to participate in 100kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321134|NCT03310450|BG002|Baseline|Group 240kms Cycling|"willing to participate in 240kms cycling touring of NC 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321135|NCT03310450|BG003|Baseline|Total|Total of all reporting groups
11321136|NCT03310450|FG000|Participant Flow|Group 140kms Cycling|"willing to participate in 140kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321137|NCT03310450|FG001|Participant Flow|Group 100kms Cycling|"willing to participate in 100kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321138|NCT03310450|FG002|Participant Flow|Group 240kms Cycling|"willing to participate in 240kms cycling touring of NC 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321139|NCT03310450|OG000|Outcome|Group 140kms Cycling|"willing to participate in 140kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321140|NCT03310450|OG001|Outcome|Group 100kms Cycling|"willing to participate in 100kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321141|NCT03310450|OG002|Outcome|Group 240kms Cycling|"willing to participate in 240kms cycling touring of NC 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321142|NCT03310450|OG000|Outcome|Group 140kms Cycling|willing to participate in 140kms cycling touring of TdB 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
11321143|NCT03310450|OG001|Outcome|Group 100kms Cycling|willing to participate in 100kms cycling touring of TdB 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
11321144|NCT03310450|OG002|Outcome|Group 240kms Cycling|willing to participate in 240kms cycling touring of NC 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
11321145|NCT03310450|EG000|Reported Event|Group 140kms Cycling|"willing to participate in 140kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321146|NCT03310450|EG001|Reported Event|Group 100kms Cycling|"willing to participate in 100kms cycling touring of TdB 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321147|NCT03310450|EG002|Reported Event|Group 240kms Cycling|"willing to participate in 240kms cycling touring of NC 2017~140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms"
11321148|NCT03310580|BG000|Baseline|AR-13324 Ophthalmic Solution 0.02%|AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321149|NCT03310580|BG001|Baseline|AR-13324 Ophthalmic Solution 0.04%|AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321150|NCT03310580|BG002|Baseline|Placebo Comparator|AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321151|NCT03310580|BG003|Baseline|Total|Total of all reporting groups
11321152|NCT03310580|FG000|Participant Flow|AR-13324 Ophthalmic Solution 0.02%|AR-13324 Ophthalmic Solution 0.02% : Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321153|NCT03310580|FG001|Participant Flow|AR-13324 Ophthalmic Solution 0.04%|AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321154|NCT03310580|FG002|Participant Flow|Placebo Comparator|AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
10827834|NCT00112112|EG001|Reported Event|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
11321155|NCT03310580|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02%|"AR-13324 ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days~AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11321156|NCT03310580|OG001|Outcome|AR-13324 Ophthalmic Solution 0.04%|"AR-13324 ophthalmic solution 0.04%; 1 drop daily to each eye for 28 days~AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution"
11321157|NCT03310580|OG002|Outcome|Placebo Comparator|"AR-13324 ophthalmic solution placebo; 1 drop daily to each eye for 28 days~AR-13324 Ophthalmic Solution Placebo; Topical sterile ophthalmic solution"
11321158|NCT03310580|OG000|Outcome|AR-13324 Ophthalmic Solution 0.02%|"AR-13324 Ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days~AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution"
11321159|NCT03310580|EG000|Reported Event|AR-13324 Ophthalmic Solution 0.02%|AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321160|NCT03310580|EG001|Reported Event|AR-13324 Ophthalmic Solution 0.04%|AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321161|NCT03310580|EG002|Reported Event|Placebo Comparator|AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
11321162|NCT03310723|BG000|Baseline|Standard Face Mask Preoxygenation|"Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.~Face Mask preoxygenation: Standard face mask preoxygenation."
11321163|NCT03310723|BG001|Baseline|Optiflow Preoxygenation|"Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.~OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
11321164|NCT03310723|BG002|Baseline|Total|Total of all reporting groups
10827835|NCT00112125|BG000|Baseline|Control Group (OMT)|Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
10827836|NCT00112125|BG001|Baseline|Treatment (OMT + CCM)|Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
10827837|NCT00112125|BG002|Baseline|Total|Total of all reporting groups
11321165|NCT03310723|FG000|Participant Flow|Standard Face Mask Preoxygenation|"Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.~Face Mask preoxygenation: Standard face mask preoxygenation."
11321166|NCT03310723|FG001|Participant Flow|Optiflow Preoxygenation|"Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.~OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
11321167|NCT03310723|OG000|Outcome|Standard Face Mask Preoxygenation|"Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.~Face Mask preoxygenation: Standard face mask preoxygenation."
11321168|NCT03310723|OG001|Outcome|Optiflow Preoxygenation|"Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.~OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
11321169|NCT03310723|EG000|Reported Event|Standard Face Mask Preoxygenation|"Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.~Face Mask preoxygenation: Standard face mask preoxygenation."
11321170|NCT03310723|EG001|Reported Event|Optiflow Preoxygenation|"Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.~OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)."
11335982|NCT03559218|FG000|Participant Flow|Standard of Care|"Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care~Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis"
11321171|NCT03310775|BG000|Baseline|Case Group|"Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321172|NCT03310775|BG001|Baseline|Waitlist Control Group|"For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks.~Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
10827838|NCT00112125|FG000|Participant Flow|Control Group (OMT)|Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
10827839|NCT00112125|FG001|Participant Flow|Treatment (CCM + OMT)|Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
11321173|NCT03310775|BG002|Baseline|Total|Total of all reporting groups
11321174|NCT03310775|FG000|Participant Flow|Case Group|"Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321175|NCT03310775|FG001|Participant Flow|Waitlist Control Group|"For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks.~Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321176|NCT03310775|OG000|Outcome|Case Group|"Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321177|NCT03310775|OG001|Outcome|Waitlist Control Group|"For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks.~Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321178|NCT03310775|EG000|Reported Event|Case Group|"Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321179|NCT03310775|EG001|Reported Event|Waitlist Control Group|"For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks.~Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks~Parent-assisted social skills training program for young adult with ASD: The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects."
11321180|NCT03310970|BG000|Baseline|All Study Participants|All study participants received IV lidocaine, generic lidocaine patches, and Lidoderm patches.
11321181|NCT03310970|FG000|Participant Flow|Group 1: Generic Lidocaine Patches First, IV Lidocaine Second, the Lidoderm(R) Topical Patches Last|"Each subject in this group received study interventions in the following order:~Each subject first wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours."
11321182|NCT03310970|FG001|Participant Flow|Group 2: Lidoderm(R) Topical Patches First, IV Lidocaine Second, Then Generic Lidocaine Patches Last|"Each subject in this group received study interventions in the following order:~Each subject first wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours."
11321183|NCT03310970|OG000|Outcome|All Study Participants|"All subjects analyzed received and completed the following interventions:~Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours.~Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours.~Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride."
11335983|NCT03559218|FG001|Participant Flow|KeraStat Cream|"Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.~KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin."
11321184|NCT03310970|OG000|Outcome|All Study Participants|"Each subject received all of the following interventions:~Each subject wore three generic 5% (Mylan Pharmaceuticals) lidocaine patches for 12 hours.~Each subject wore three lidoderm(R) 5% (Endo Pharmaceuticals) lidocaine patches for 12 hours.~Each subject received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride."
11321185|NCT03310970|EG000|Reported Event|Lidocaine Patch|Each subject will wear three generic lidocaine patches for 12 hours.
11321186|NCT03310970|EG001|Reported Event|Lidoderm ® Topical Patch|Each subject will wear three Lidoderm® topical patches for 12 hours.
11321187|NCT03310970|EG002|Reported Event|Intravenous Lidocaine|A single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject.
11321188|NCT03311230|BG000|Baseline|Control|Participants in this arm will receive no other interventions during the 9 month study period
11321189|NCT03311230|BG001|Baseline|Supportive Social Incentive|"Participants will identify a family member or friend to support them during a gamification intervention.~Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress."
11321190|NCT03311230|BG002|Baseline|Competitive Social Incentive|"Participants will compete in a gamification intervention in groups of three.~Competitive social incentive: Participants in this intervention will be competing against each other in the game."
11321191|NCT03311230|BG003|Baseline|Collaborative Social Incentive|"Participants will collaborate in groups of three in a gamification intervention~Collaborative social incentive: Participants in this intervention will be working with each other in the game."
11321192|NCT03311230|BG004|Baseline|Total|Total of all reporting groups
11321193|NCT03311230|FG000|Participant Flow|Control|Participants in this arm will receive no other interventions during the 9 month study period
11321194|NCT03311230|FG001|Participant Flow|Supportive Social Incentive|"Participants will identify a family member or friend to support them during a gamification intervention.~Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress."
11321195|NCT03311230|FG002|Participant Flow|Competitive Social Incentive|"Participants will compete in a gamification intervention in groups of three.~Competitive social incentive: Participants in this intervention will be competing against each other in the game."
11321196|NCT03311230|FG003|Participant Flow|Collaborative Social Incentive|"Participants will collaborate in groups of three in a gamification intervention~Collaborative social incentive: Participants in this intervention will be working with each other in the game."
11321197|NCT03311230|OG000|Outcome|Control|Participants in this arm will receive no other interventions during the 9 month study period
11321198|NCT03311230|OG001|Outcome|Supportive Social Incentive|"Participants will identify a family member or friend to support them during a gamification intervention.~Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress."
11321199|NCT03311230|OG002|Outcome|Competitive Social Incentive|"Participants will compete in a gamification intervention in groups of three.~Competitive social incentive: Participants in this intervention will be competing against each other in the game."
11321200|NCT03311230|OG003|Outcome|Collaborative Social Incentive|"Participants will collaborate in groups of three in a gamification intervention~Collaborative social incentive: Participants in this intervention will be working with each other in the game."
11321201|NCT03311230|EG000|Reported Event|Control|Participants in this arm will receive no other interventions during the 9 month study period
11321202|NCT03311230|EG001|Reported Event|Supportive Social Incentive|"Participants will identify a family member or friend to support them during a gamification intervention.~Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress."
11321203|NCT03311230|EG002|Reported Event|Competitive Social Incentive|"Participants will compete in a gamification intervention in groups of three.~Competitive social incentive: Participants in this intervention will be competing against each other in the game."
11321204|NCT03311230|EG003|Reported Event|Collaborative Social Incentive|"Participants will collaborate in groups of three in a gamification intervention~Collaborative social incentive: Participants in this intervention will be working with each other in the game."
11321205|NCT03311373|BG000|Baseline|All Subjects|All subjects
11321206|NCT03311373|FG000|Participant Flow|All Regimens|BGF MDI 320/28.8/9.6 μg
11321207|NCT03311373|OG000|Outcome|Regimen B|BGF MDI 320/28.8/9.6 μg with a spacer device and without charcoal
11321208|NCT03311373|OG001|Outcome|Regimen A|BGF MDI 320/28.8/9.6 μg without spacer device and without charcoal
11321209|NCT03311373|OG002|Outcome|Regimen C|BGF MDI 320/28.8/9.6 μg without a spacer device and with charcoal
11321210|NCT03311373|OG003|Outcome|Regimen D|BGF MDI 320/28.8/9.6 μg with a spacer device and with charcoal
11321211|NCT03311373|EG000|Reported Event|Regimen B|BGF MDI 320/28.8/9.6 μg with a spacer device and without charcoal
11321212|NCT03311373|EG001|Reported Event|Regimen A|BGF MDI 320/28.8/9.6 μg without spacer device and without charcoal
11321213|NCT03311373|EG002|Reported Event|Regimen C|BGF MDI 320/28.8/9.6 μg without a spacer device and with charcoal
11321214|NCT03311373|EG003|Reported Event|Regimen D|BGF MDI 320/28.8/9.6 μg with a spacer device and with charcoal
11321215|NCT03311646|BG000|Baseline|Nicotine Content Manipulation|All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. During both the NNC and VLNC conditions, participants stay in a hotel and exclusively use the cigarettes provided to them. Each condition lasts four nights / five days. Baseline outcomes for the NNC condition are reported below, and VLNC condition outcomes are reported in the results section.
11321216|NCT03311646|FG000|Participant Flow|Very Low Nicotine Content|All participants receive normal nicotine content (NNC) cigarettes during baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition.
11321217|NCT03311646|OG000|Outcome|Very Low Nicotine Content|All participants receive normal nicotine content (NNC) cigarettes during baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition.
11321218|NCT03311646|OG000|Outcome|Very Low Nicotine Content|"Participants will receive both normal nicotine content cigarettes and very low nicotine content cigarettes~Normal nicotine content cigarettes: Participants will smoke research cigarettes that have a normal nicotine content~Lower nicotine content cigarettes: Participants will smoke research cigarettes that have a lower nicotine content"
11321219|NCT03311646|EG000|Reported Event|Nicotine Content Manipulation|All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition. During both the NNC and VLNC conditions, participants stay in a hotel and exclusively use the cigarettes provided to them. Each condition lasts four nights / five days. Adverse events reported below may have been reported during either the NNC or VLNC condition.
11333397|NCT03513757|OG001|Outcome|Propofol Dexmedetomidine|"Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists.~Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mcg/kg to 1.25 mcg/kg.~Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group."
11333398|NCT03513757|EG000|Reported Event|Propofol|"Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists"
11333399|NCT03513757|EG001|Reported Event|Propofol Dexmedetomidine|"Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.~propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists~Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg"
11333400|NCT03513848|BG000|Baseline|Bright Light|Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
11333401|NCT03513848|BG001|Baseline|Dim Light|Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
11333402|NCT03513848|BG002|Baseline|Total|Total of all reporting groups
11333403|NCT03513848|FG000|Participant Flow|Bright Light|Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
11333404|NCT03513848|FG001|Participant Flow|Dim Light|Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
11333405|NCT03513848|OG000|Outcome|Bright Light|Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
11333406|NCT03513848|OG001|Outcome|Dim Light|Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
11333407|NCT03513848|EG000|Reported Event|Bright Light|Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
11333408|NCT03513848|EG001|Reported Event|Dim Light|Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
11333409|NCT03514277|BG000|Baseline|Local Infiltration of EXPAREL and Bupivacaine|"Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL~Bupivacaine: 30 mL bupivacaine 0.5% w/v solution"
11333410|NCT03514277|BG001|Baseline|Local Infiltration of Exparel|Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
11333411|NCT03514277|BG002|Baseline|Local Infiltration of Bupivacaine|Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
11333412|NCT03514277|BG003|Baseline|Total|Total of all reporting groups
11333413|NCT03514277|FG000|Participant Flow|Local Infiltration of EXPAREL and Bupivacaine|"Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL~Bupivacaine: 30 mL bupivacaine 0.5% w/v solution"
11333414|NCT03514277|FG001|Participant Flow|Local Infiltration of Exparel|Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
11333415|NCT03514277|FG002|Participant Flow|Local Infiltration of Bupivacaine|Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
11333416|NCT03514277|OG000|Outcome|Local Infiltration of EXPAREL and Bupivacaine|"Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL~Bupivacaine: 30 mL bupivacaine 0.5% w/v solution"
11333417|NCT03514277|OG001|Outcome|Local Infiltration of Exparel|Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
11333418|NCT03514277|OG002|Outcome|Local Infiltration of Bupivacaine|Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
11321220|NCT03311659|BG000|Baseline|dTpa Group|Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
11321221|NCT03311659|FG000|Participant Flow|dTpa Group|Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
11321222|NCT03311659|OG000|Outcome|dTpa Group|Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
11321223|NCT03311659|EG000|Reported Event|dTpa Group|Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
11321224|NCT03311724|BG000|Baseline|Placebo|Placebo administered by SC injection.
11321225|NCT03311724|BG001|Baseline|4, 8 and 12mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
11321226|NCT03311724|BG002|Baseline|2.5, 5, 10, and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
11321227|NCT03311724|BG003|Baseline|2.5, 7.5 and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
11321228|NCT03311724|BG004|Baseline|Total|Total of all reporting groups
11321229|NCT03311724|FG000|Participant Flow|Placebo|Participants received Placebo by subcutaneous (SC) injection.
11321230|NCT03311724|FG001|Participant Flow|4, 8 and 12mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
11321231|NCT03311724|FG002|Participant Flow|2.5, 5, 10, and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
11321232|NCT03311724|FG003|Participant Flow|2.5, 7.5 and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
11321233|NCT03311724|OG000|Outcome|Placebo|Placebo administered SC.
11321234|NCT03311724|OG001|Outcome|4, 8 and 12mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
11321235|NCT03311724|OG002|Outcome|2.5, 5, 10, and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
11321236|NCT03311724|OG003|Outcome|2.5, 7.5 and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
11321237|NCT03311724|OG000|Outcome|4, 8 and 12mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
11321238|NCT03311724|OG001|Outcome|2.5, 5, 10, and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
11321239|NCT03311724|OG002|Outcome|2.5, 7.5 and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
11321240|NCT03311724|EG000|Reported Event|Placebo|Placebo administered SC
11321241|NCT03311724|EG001|Reported Event|4, 8 and 12mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 4mg for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
11321242|NCT03311724|EG002|Reported Event|2.5, 5, 10, and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
11321243|NCT03311724|EG003|Reported Event|2.5, 7.5 and 15mg Tirzepatide|Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
11321244|NCT03311841|BG000|Baseline|End-Stage Renal Disease|Participants requiring hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). A washout period of at least 14 days will separate dosings
11321245|NCT03311841|BG001|Baseline|Severe Impairment|Participants with <30 mL/min/1.73m^2 estimated glomerular filtration rate (eGFR) not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321246|NCT03311841|BG002|Baseline|Moderate Impairment|Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321247|NCT03311841|BG003|Baseline|Mild Impairment|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321248|NCT03311841|BG004|Baseline|Healthy Control|Participants with ≥90 mL/min creatinine clearance. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321249|NCT03311841|BG005|Baseline|Total|Total of all reporting groups
11321250|NCT03311841|FG000|Participant Flow|End-Stage Renal Disease|Participants requiring hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). A washout period of at least 14 days will separate dosings
11321251|NCT03311841|FG001|Participant Flow|Severe Impairment|Participants with <30 mL/min/1.73m^2 estimated glomerular filtration rate (eGFR) not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321252|NCT03311841|FG002|Participant Flow|Moderate Impairment|Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321253|NCT03311841|FG003|Participant Flow|Mild Impairment|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321254|NCT03311841|FG004|Participant Flow|Healthy Control|Participants with ≥90 mL/min creatinine clearance. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321255|NCT03311841|OG000|Outcome|End-Stage Renal Disease|Participants requiring hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). A washout period of at least 14 days will separate dosings
11321256|NCT03311841|OG001|Outcome|Severe Impairment|Participants with <30 mL/min/1.73m^2 estimated glomerular filtration rate (eGFR) not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321257|NCT03311841|OG002|Outcome|Moderate Impairment|Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321258|NCT03311841|OG003|Outcome|Mild Impairment|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11333419|NCT03514277|EG000|Reported Event|Local Infiltration of EXPAREL and Bupivacaine|"Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL~Bupivacaine: 30 mL bupivacaine 0.5% w/v solution"
11333420|NCT03514277|EG001|Reported Event|Local Infiltration of Exparel|Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
11333421|NCT03514277|EG002|Reported Event|Local Infiltration of Bupivacaine|Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
11333422|NCT03514420|BG000|Baseline|AKCEA-ANGPTL3-LRx 20 mg|Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.
11321259|NCT03311841|OG004|Outcome|Healthy Control|Participants with ≥90 mL/min creatinine clearance. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321260|NCT03311841|OG000|Outcome|End Stage Renal Disease (Period 2)|Participants requiring hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution).
11321261|NCT03311841|OG001|Outcome|Severe Impairment (Period 2)|Participants with <30 mL/min/1.73m^2 estimated glomerular filtration rate (eGFR) not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin.
11321262|NCT03311841|OG002|Outcome|Moderate Impairment (Period 2)|Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin.
11321263|NCT03311841|OG003|Outcome|Mild Impairment (Period 2)|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin.
11321264|NCT03311841|OG004|Outcome|Healthy Control (Period 2)|Participants with ≥90 mL/min creatinine clearance. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin.
11321265|NCT03311841|EG000|Reported Event|End Stage Renal Disease: Microdose Cocktail Alone|"Participants requiring hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution).~Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). A washout period of at least 14 days will separate dosings."
11321266|NCT03311841|EG001|Reported Event|Severe Impairment: Microdose Cocktail Alone|Participants with <30 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution).
11321267|NCT03311841|EG002|Reported Event|Severe Impairment: Microdose Cocktail + Rifampin|Participants with <30 mL/min/1.73m^2 eGFR not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321268|NCT03311841|EG003|Reported Event|Moderate Impairment: Microdose Cocktail Alone|Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution).
11321269|NCT03311841|EG004|Reported Event|Moderate Impairment: Microdose Cocktail + Rifampin|Moderate ImpairmentEdit Participants with 30 to <60 mL/min/1.73m^2 eGFR not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321270|NCT03311841|EG005|Reported Event|Mild Impairment: Microdose Cocktail Alone|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution).
11321271|NCT03311841|EG006|Reported Event|Mild Impairment: Microdose Cocktail + Rifampin|Participants with 60 to <90 mL/min/1.73m^2 eGFR not on hemodialysis. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321272|NCT03311841|EG007|Reported Event|Healthy Control: Microdose Cocktail Alone|Participants with ≥90 mL/min creatinine clearance. Period 1/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321273|NCT03311841|EG008|Reported Event|Healthy Control: Microdose Cocktail + Rifampin|Participants with ≥90 mL/min creatinine clearance. Period 2/Day 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.
11321274|NCT03312023|BG000|Baseline|Group A (LDV/SOF for Low Replicative HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321275|NCT03312023|BG001|Baseline|Group B (LDV/SOF for Viral Suppressed HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321276|NCT03312023|BG002|Baseline|Group C (SOF for Low Replicative HBV)|"12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group D.~Sofosbuvir 400 MG [Sovaldi]: 1 pill once daily for 12 weeks for Group C"
11333423|NCT03514420|FG000|Participant Flow|AKCEA-ANGPTL3-LRx 20 mg|Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by subcutaneous (SC) injection.
11321277|NCT03312023|BG003|Baseline|Group D (LDV for Low Replicative HBV)|"12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group C.~Ledipasvir 90 MG: 1 pill once daily for 12 weeks for Group D"
11321278|NCT03312023|BG004|Baseline|Total|Total of all reporting groups
11321279|NCT03312023|FG000|Participant Flow|Group A (LDV/SOF for Low Replicative HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321280|NCT03312023|FG001|Participant Flow|Group B (LDV/SOF for Viral Suppressed HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321281|NCT03312023|FG002|Participant Flow|Group C (SOF for Low Replicative HBV)|"12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group D.~Sofosbuvir 400 MG [Sovaldi]: 1 pill once daily for 12 weeks for Group C"
11321282|NCT03312023|FG003|Participant Flow|Group D (LDV for Low Replicative HBV)|"12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group C.~Ledipasvir 90 MG: 1 pill once daily for 12 weeks for Group D"
11321283|NCT03312023|OG000|Outcome|Group A (LDV/SOF for Low Replicative HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321284|NCT03312023|OG001|Outcome|Group B (LDV/SOF for Viral Suppressed HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321285|NCT03312023|OG002|Outcome|Group C (SOF for Low Replicative HBV)|"12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group D.~Sofosbuvir 400 MG [Sovaldi]: 1 pill once daily for 12 weeks for Group C"
11321286|NCT03312023|OG003|Outcome|Group D (LDV for Low Replicative HBV)|"12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group C.~Ledipasvir 90 MG: 1 pill once daily for 12 weeks for Group D"
11321287|NCT03312023|OG001|Outcome|Group B (LDV/SOF for Virally Suppressed HBV)|12 weeks of treatment with ledipasvir/sofosbuvir (Harvoni) for chronical hepatitis B virally suppressed on HBV meds
11321288|NCT03312023|EG000|Reported Event|Group A (LDV/SOF for Low Replicative HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321289|NCT03312023|EG001|Reported Event|Group B (LDV/SOF for Viral Suppressed HBV)|"12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed.~Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]: 1 pill once daily for 12 weeks for Group A"
11321290|NCT03312023|EG002|Reported Event|Group C (SOF for Low Replicative HBV)|"12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group D.~Sofosbuvir 400 MG [Sovaldi]: 1 pill once daily for 12 weeks for Group C"
11321291|NCT03312023|EG003|Reported Event|Group D (LDV for Low Replicative HBV)|"12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state.~Randomized 1:1 with Group C.~Ledipasvir 90 MG: 1 pill once daily for 12 weeks for Group D"
11321292|NCT03312114|BG000|Baseline|Single Arm|"Avelumab and SABR~Avelumab: Avelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)"
11321293|NCT03312114|FG000|Participant Flow|Single Arm|"Avelumab and SABR~Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria."
11321294|NCT03312114|OG000|Outcome|Recurrent Ovarian and Peritoneal ,Fallopian Tube Cancer (ROP|The primary objective of this phase II(with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria . This will be after the safety lead-in is completed without DLT at 8 weeks from start of Avelumab, to evaluate the safety of Avelumab and SABR to an acceptable dose of the site radiated.
11321295|NCT03312114|OG000|Outcome|Single Arm|"Avelumab and SABR~Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria."
11321296|NCT03312114|EG000|Reported Event|Concurrent Anti-PD-L1 + SAbR to Metastasis|There were no serious adverse events on the trial.
11321297|NCT03312218|BG000|Baseline|Intervention|"Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).~Spaced educational intervention: A spaced educational intervention will be provided to participants"
11321298|NCT03312218|BG001|Baseline|Control|Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).
11321299|NCT03312218|BG002|Baseline|Total|Total of all reporting groups
11321300|NCT03312218|FG000|Participant Flow|Intervention|"Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).~Spaced educational intervention: A spaced educational intervention will be provided to participants"
11321301|NCT03312218|FG001|Participant Flow|Control|Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).
11321302|NCT03312218|OG000|Outcome|Intervention|"Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).~Spaced educational intervention: A spaced educational intervention will be provided to participants"
11321303|NCT03312218|OG001|Outcome|Control|Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).
11321304|NCT03312218|EG000|Reported Event|Intervention|"Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).~Spaced educational intervention: A spaced educational intervention will be provided to participants"
11321305|NCT03312218|EG001|Reported Event|Control|Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).
11321306|NCT03312231|BG000|Baseline|Group 1|"3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321307|NCT03312231|BG001|Baseline|Group 2|"7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321308|NCT03312231|BG002|Baseline|Group 3|"15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321309|NCT03312231|BG003|Baseline|Group 4|"15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321310|NCT03312231|BG004|Baseline|Group 5|"45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321311|NCT03312231|BG005|Baseline|Total|Total of all reporting groups
11321312|NCT03312231|FG000|Participant Flow|Group 1|"3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22.~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321313|NCT03312231|FG001|Participant Flow|Group 2|"7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321314|NCT03312231|FG002|Participant Flow|Group 3|"15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321315|NCT03312231|FG003|Participant Flow|Group 4|"15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321316|NCT03312231|FG004|Participant Flow|Group 5|"45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321317|NCT03312231|OG000|Outcome|Group 1|"3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321318|NCT03312231|OG001|Outcome|Group 2|"7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321319|NCT03312231|OG002|Outcome|Group 3|"15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321320|NCT03312231|OG003|Outcome|Group 4|"15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321321|NCT03312231|OG004|Outcome|Group 5|"45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321322|NCT03312231|EG000|Reported Event|Group 1|"3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321323|NCT03312231|EG001|Reported Event|Group 2|"7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321324|NCT03312231|EG002|Reported Event|Group 3|"15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine~AS03: Oil-in-water emulsion based adjuvant system."
11321325|NCT03312231|EG003|Reported Event|Group 4|"15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321326|NCT03312231|EG004|Reported Event|Group 5|"45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22~Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine"
11321327|NCT03312348|BG000|Baseline|Infrared Imaging Undertaken|"Infrared imaging of Region Of Interest in study participants~Infrared imaging: Infrared image image acquisition of study participants"
11321328|NCT03312348|FG000|Participant Flow|Infrared Imaging Undertaken|"Infrared imaging of Region Of Interest in study participants~Infrared imaging: Infrared image image acquisition of study participants"
11321329|NCT03312348|OG000|Outcome|Infrared Imaging Undertaken|"Infrared imaging of Region Of Interest in study participants~Infrared imaging: Infrared image image acquisition of study participants"
11321330|NCT03312348|EG000|Reported Event|Infrared Imaging Undertaken|"Infrared imaging of Region Of Interest in study participants~Infrared imaging: Infrared image image acquisition of study participants"
11321331|NCT03312517|BG000|Baseline|Analyzed Sample|Crossover study, all subjects will receive belsomra 10mg, belsomra 20mg and placebo before bedtime in 3 separate overnights. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321332|NCT03312517|FG000|Participant Flow|Placebo Then Suvorexant 10mg, Then Suvorexant 20mg|Subjects first received Placebo, then Suvorexant 10mg, then Suvorexant 20mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321333|NCT03312517|FG001|Participant Flow|Placebo, Then Suvorexant 20mg, Then Suvorexant 10mg|Subjects first received Placebo, then Suvorexant 20mg, then Suvorexant 10mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321334|NCT03312517|FG002|Participant Flow|Suvorexant 10, Then Placebo, Then Suvorexant 20|Subjects first received Suvorexant 10mg, then placebo, then Suvorexant 20mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321335|NCT03312517|FG003|Participant Flow|Suvorexant 10mg, Then Suvorexant 20mg, Then Placebo|Subjects first received Suvorexant 10mg, then Suvorexant 20mg, then placebo. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321336|NCT03312517|FG004|Participant Flow|Suvorexant 20mg, Placebo, Suvorexant 10mg|Subjects first received Suvorexant 20mg, placebo, then Suvorexant 10mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321337|NCT03312517|FG005|Participant Flow|Suvorexant 20, Suvorexant 10mg, Placebo|Subjects first received Suvorexant 20, then Suvorexant 10mg, then Placebo. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
11321338|NCT03312517|OG000|Outcome|Suvorexant 10mg|"Subjects will receive belsomra 10mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.~Suvorexant 10 mg: Subject will receive suvorexant 10mg"
11321339|NCT03312517|OG001|Outcome|Suvorexant 20mg|"Subjects will receive belsomra 20mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.~Suvorexant 20 mg: Subject will receive suvorexant 20mg"
11321340|NCT03312517|OG002|Outcome|Placebo Oral Capsule|"Subjects will receive placebo before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.~Placebo oral capsule: Subject will receive placebo."
11321341|NCT03312517|EG000|Reported Event|Placebo|All 12 subjects received placebo, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
11321342|NCT03312517|EG001|Reported Event|Belsomra 20mg|All 12 subjects received belsomra 20mg, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
11321343|NCT03312517|EG002|Reported Event|Belsomra 10mg|All 12 subjects received belsomra 10mg, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
11321344|NCT03312543|BG000|Baseline|Sham Cell: Sham Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321345|NCT03312543|BG001|Baseline|Active Cell: Active Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321346|NCT03312543|BG002|Baseline|Total|Total of all reporting groups
11321347|NCT03312543|FG000|Participant Flow|Sham Cell: Sham Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321348|NCT03312543|FG001|Participant Flow|Active Cell: Active Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321349|NCT03312543|OG000|Outcome|Sham Cell: Sham Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321350|NCT03312543|OG001|Outcome|Active Cell: Active Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321351|NCT03312543|EG000|Reported Event|Sham Cell: Sham Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321352|NCT03312543|EG001|Reported Event|Active Cell: Active Mask|A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
11321353|NCT03312595|BG000|Baseline|Restrata Wound Matrix|"Prospective, single armed, non-randomized study with direct assignment~Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds"
11321354|NCT03312595|FG000|Participant Flow|Restrata Wound Matrix|"Prospective, single armed, non-randomized study with direct assignment~Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds"
11321355|NCT03312595|OG000|Outcome|Restrata Wound Matrix|"Prospective, single armed, non-randomized study with direct assignment~Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds"
11321356|NCT03312595|EG000|Reported Event|Restrata Wound Matrix|"Prospective, single armed, non-randomized study with direct assignment~Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds"
11333424|NCT03514420|OG000|Outcome|AKCEA-ANGPTL3-LRx 20 mg|Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by SC injection.
11333425|NCT03514420|EG000|Reported Event|AKCEA-ANGPTL3-LRx 20 mg|Participants received AKCEA-ANGPTL3-LRx 20 mg administered every week for 26 weeks by subcutaneous (SC) injection.
11333426|NCT03514641|BG000|Baseline|603A: Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 12 weeks.
11333427|NCT03514641|BG001|Baseline|603 A: Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 12 weeks.
11321357|NCT03312933|BG000|Baseline|CAM Walker Boot for >2 Weeks|All patients who were placed into a CAM walker boot for >2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
11321358|NCT03312933|FG000|Participant Flow|CAM Walker Boot for >2 Weeks|All patients who were placed into a CAM walker boot for >2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
11321359|NCT03312933|OG000|Outcome|Duration of CAM Walking Boot Wear >2 Weeks|All patients who were placed into a CAM walker boot for >2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
11321360|NCT03312933|EG000|Reported Event|CAM Walker Boot for >2 Weeks|All patients who were placed into a CAM walker boot for >2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
11321361|NCT03313037|BG000|Baseline|20vPnC Followed by Saline|Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321362|NCT03313037|BG001|Baseline|13vPnC Followed by PPSV23|Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321363|NCT03313037|BG002|Baseline|Total|Total of all reporting groups
11321364|NCT03313037|FG000|Participant Flow|20vPnC Followed by Saline|Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321365|NCT03313037|FG001|Participant Flow|13vPnC Followed by PPSV23|Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321366|NCT03313037|OG000|Outcome|20vPnC Followed by Saline|Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321367|NCT03313037|OG001|Outcome|13vPnC Followed by PPSV23|Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321368|NCT03313037|EG000|Reported Event|20vPnC Followed by Saline|Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321369|NCT03313037|EG001|Reported Event|13vPnC Followed by PPSV23|Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
11321370|NCT03313050|BG000|Baseline|Stage 1: c7vPnC (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
11321371|NCT03313050|BG001|Baseline|Stage 1: Tdap (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
11321372|NCT03313050|BG002|Baseline|Stage 2: c7vPnC (65 to 85 Years of Age)|In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321373|NCT03313050|BG003|Baseline|Stage 2: PPSV23 (65 to 85 Years of Age)|In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321374|NCT03313050|BG004|Baseline|Total|Total of all reporting groups
11321375|NCT03313050|FG000|Participant Flow|Stage 1: c7vPnC (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
11321376|NCT03313050|FG001|Participant Flow|Stage 1: Tdap (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
11321377|NCT03313050|FG002|Participant Flow|Stage 2: c7vPnC (65 to 85 Years of Age)|In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321378|NCT03313050|FG003|Participant Flow|Stage 2: PPSV23 (65 to 85 Years of Age)|In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321379|NCT03313050|OG000|Outcome|Stage 1: c7vPnC (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
11321380|NCT03313050|OG001|Outcome|Stage 1: Tdap (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
11321381|NCT03313050|OG000|Outcome|Stage 2: c7vPnC (65 to 85 Years of Age)|In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321382|NCT03313050|OG001|Outcome|Stage 2: PPSV23 (65 to 85 Years of Age)|In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321383|NCT03313050|EG000|Reported Event|Stage 1: c7vPnC (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
11321384|NCT03313050|EG001|Reported Event|Stage 1: Tdap (50 to 64 Years of Age)|In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
11321385|NCT03313050|EG002|Reported Event|Stage 2: c7vPnC (65 to 85 Years of Age)|In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321386|NCT03313050|EG003|Reported Event|Stage 2: PPSV23 (65 to 85 Years of Age)|In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
11321387|NCT03313076|BG000|Baseline|n-3 PUFA (O3FA) + Vitamin D3|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment."
11321388|NCT03313076|BG001|Baseline|n-3 PUFA (O3FA) Placebo + Vitamin D3|"4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321389|NCT03313076|BG002|Baseline|n-3 PUFAs (O3FA) + Vitamin D3 Placebo|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment."
11321390|NCT03313076|BG003|Baseline|n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo|"4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321391|NCT03313076|BG004|Baseline|Total|Total of all reporting groups
11321392|NCT03313076|FG000|Participant Flow|n-3 PUFA (O3FA) + Vitamin D3|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment."
11321393|NCT03313076|FG001|Participant Flow|n-3 PUFA (O3FA) Placebo + Vitamin D3|"4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321394|NCT03313076|FG002|Participant Flow|n-3 PUFAs (O3FA) + Vitamin D3 Placebo|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment."
11321395|NCT03313076|FG003|Participant Flow|n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo|"4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321396|NCT03313076|OG000|Outcome|n-3 PUFA (O3FA) + Vitamin D3|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment."
11321397|NCT03313076|OG001|Outcome|n-3 PUFAs (O3FA) + Vitamin D3 Placebo|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment."
11321398|NCT03313076|OG002|Outcome|n-3 PUFA (O3FA) Placebo + Vitamin D3|"4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321399|NCT03313076|OG003|Outcome|n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo|"4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321400|NCT03313076|OG001|Outcome|n-3 PUFA (O3FA) Placebo + Vitamin D3|"4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321401|NCT03313076|OG002|Outcome|n-3 PUFAs (O3FA) + Vitamin D3 Placebo|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules.This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment."
11321402|NCT03313076|OG000|Outcome|Omega-3|Omega 3 active treatment
11321403|NCT03313076|OG001|Outcome|No Omega 3 Treatment|Omega 3 placebo
11321404|NCT03313076|OG002|Outcome|Vitamin D|Vitamin D active treatment
11321405|NCT03313076|OG003|Outcome|No Vitamin D Treatment|Vitamin D placebo
11321406|NCT03313076|EG000|Reported Event|n-3 PUFA (O3FA) + Vitamin D3|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment."
11321407|NCT03313076|EG001|Reported Event|n-3 PUFA (O3FA) Placebo + Vitamin D3|"4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule~Vitamin D3 (cholecalciferol): 1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321408|NCT03313076|EG002|Reported Event|n-3 PUFAs (O3FA) + Vitamin D3 Placebo|"4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule~Omega-3 fatty acids (fish oil): 4 capsules. This will be administered daily, by mouth for 6 weeks~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment."
11321409|NCT03313076|EG003|Reported Event|n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo|"4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule~Vitamin D3 (cholecalciferol) placebo: 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.~Omega-3 fatty acid placebo: 4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment."
11321410|NCT03313310|BG000|Baseline|Phase 2|Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.
11321411|NCT03313310|BG001|Baseline|Phase 3|Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
11321412|NCT03313310|BG002|Baseline|Total|Total of all reporting groups
11321413|NCT03313310|FG000|Participant Flow|Phase 2|Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.
11321414|NCT03313310|FG001|Participant Flow|Phase 3|Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
11321415|NCT03313310|OG000|Outcome|Phase 2|Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.
11321416|NCT03313310|OG001|Outcome|Phase 3|Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
11321417|NCT03313310|EG000|Reported Event|Phase 2|Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.
11321418|NCT03313310|EG001|Reported Event|Phase 3|Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
11321419|NCT03314233|BG000|Baseline|DING Intervention|"Delayed Cord Clamping~DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) gentle ventilation protocol."
11321420|NCT03314233|FG000|Participant Flow|DING Intervention|"Delayed Cord Clamping~DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) gentle ventilation protocol."
11321421|NCT03314233|OG000|Outcome|DING Intervention|"Delayed Cord Clamping~DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) gentle ventilation protocol."
11321422|NCT03314233|EG000|Reported Event|DING Intervention|"Delayed Cord Clamping~DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) gentle ventilation protocol."
11321423|NCT03314519|BG000|Baseline|Ultrasonography|"Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.~Lung ultrasonography by experienced anaesthesiologist: Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard"
11321424|NCT03314519|BG001|Baseline|Fiberoptic Bronchoscopy|"Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.~Fiberoptic bronchoscopy for double lumen tube's position: Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard"
11321425|NCT03314519|BG002|Baseline|Total|Total of all reporting groups
11321426|NCT03314519|FG000|Participant Flow|Ultrasonography|"Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.~Lung ultrasonography by experienced anaesthesiologist: Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard"
11321427|NCT03314519|FG001|Participant Flow|Fiberoptic Bronchoscopy|"Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.~Fiberoptic bronchoscopy for double lumen tube's position: Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard"
11321428|NCT03314519|OG000|Outcome|Ultrasonography|"Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.~Lung ultrasonography by experienced anaesthesiologist: Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard"
11321429|NCT03314519|OG001|Outcome|Fiberoptic Bronchoscopy|"Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.~Fiberoptic bronchoscopy for double lumen tube's position: Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard"
11321430|NCT03314519|EG000|Reported Event|Ultrasonography|"Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.~Lung ultrasonography by experienced anaesthesiologist: Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard"
11321431|NCT03314519|EG001|Reported Event|Fiberoptic Bronchoscopy|"Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.~Fiberoptic bronchoscopy for double lumen tube's position: Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard"
11321432|NCT03314662|BG000|Baseline|aQIV|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
11321433|NCT03314662|BG001|Baseline|aTIV-1|Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
10827840|NCT00112125|OG000|Outcome|Control Group (OMT)|Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
11321434|NCT03314662|BG002|Baseline|aTIV-2|MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
11321435|NCT03314662|BG003|Baseline|Total|Total of all reporting groups
11321436|NCT03314662|FG000|Participant Flow|aQIV|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
11321437|NCT03314662|FG001|Participant Flow|aTIV-1|Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
11321438|NCT03314662|FG002|Participant Flow|aTIV-2|MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
11321439|NCT03314662|OG000|Outcome|aQIV|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
11321440|NCT03314662|OG001|Outcome|aTIV-1|Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
11321441|NCT03314662|OG002|Outcome|aTIV-2|MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
11321442|NCT03314662|OG003|Outcome|aTIV-1/aTIV-2|Pooled Subjects Treated with aTIV-1 and aTIV-2
11321443|NCT03314662|OG001|Outcome|aTIV-1|Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines
11321444|NCT03314662|OG002|Outcome|aTIV-2|MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain)
11321445|NCT03314662|OG000|Outcome|aQIV|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine.
11321446|NCT03314662|OG000|Outcome|aQIV|"MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.~MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines."
11321447|NCT03314662|OG001|Outcome|aTIV-1|"Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.~Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines."
11321448|NCT03314662|OG002|Outcome|aTIV-2|"MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.~MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain)."
11321449|NCT03314662|OG003|Outcome|aTIV-1/aTIV-2|Pooled Subjects Treated with aTIV-1 and aTIV-2.
11321450|NCT03314662|EG000|Reported Event|aQIV|"MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.~MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines."
11333428|NCT03514641|BG002|Baseline|603B: Bexagliflozin Tablets, 20 mg|Each eligible subject who have completed 603A including two successful 24-h ABPM sessions at 603A baseline and at week 12, and have completed the 12 weeks open labeled bexagliflozin run-in period with a successful 24-h ABPM session at week 12 of 603B, will receive bexagliflozin tablets, 20 mg once daily for 12 weeks.
10827841|NCT00112125|OG001|Outcome|Treatment (CCM + OMT)|Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
11321451|NCT03314662|EG001|Reported Event|aTIV-1|"Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.~Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines."
11321452|NCT03314662|EG002|Reported Event|aTIV-2|"MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.~MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain)."
11321453|NCT03314753|BG000|Baseline|Radiofrequency Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; Manufacturer Biosense Webster, Inc.).~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321454|NCT03314753|BG001|Baseline|Cryoballoon Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic Front Advance® Cardiac CryoAblation Catheter System.~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321455|NCT03314753|BG002|Baseline|Total|Total of all reporting groups
11321456|NCT03314753|FG000|Participant Flow|Radiofrequency Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; Manufacturer Biosense Webster, Inc.).~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321457|NCT03314753|FG001|Participant Flow|Cryoballoon Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic Front Advance® Cardiac CryoAblation Catheter System.~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321458|NCT03314753|OG000|Outcome|Radiofrequency Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; Manufacturer Biosense Webster, Inc.).~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11333429|NCT03514641|BG003|Baseline|603B: Placebo Tablets|Each eligible subject who have completed 603A including two successful 24-h ABPM sessions at 603A baseline and at week 12, and have completed the 12 weeks open labeled bexagliflozin run-in period with a successful 24-h ABPM session at week 12 of 603B, will receive placebo (inactive tablets) once daily for 12 weeks.
11333430|NCT03514641|BG004|Baseline|Total|Total of all reporting groups
11333431|NCT03514641|FG000|Participant Flow|603A: Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 12 weeks
10827842|NCT00112125|EG000|Reported Event|Control Group (OMT)|Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
11321459|NCT03314753|OG001|Outcome|Cryoballoon Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic Front Advance® Cardiac CryoAblation Catheter System.~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321460|NCT03314753|EG000|Reported Event|Radiofrequency Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; Manufacturer Biosense Webster, Inc.).~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11321461|NCT03314753|EG001|Reported Event|Cryoballoon Arm From FIRE AND ICE Trial|"No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial.~The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF).~Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic Front Advance® Cardiac CryoAblation Catheter System.~The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial.~No interventions - retrospective data collection: No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial"
11333432|NCT03514641|FG001|Participant Flow|603A: Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 12 weeks.
11333433|NCT03514641|FG002|Participant Flow|603B: Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 12 weeks from week 24 to week 36 (cumulative)
11333434|NCT03514641|FG003|Participant Flow|603B: Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 12 weeks from week 24 to week 36 (cumulative)
11333435|NCT03514641|OG000|Outcome|Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 12 weeks.
11333436|NCT03514641|OG001|Outcome|Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 12 weeks.
11333437|NCT03514641|OG000|Outcome|Effect on Mean Ambulatory SBP|Effect on ABPM SBP after 12, 24, and 36 weeks of cumulative exposure to Bexagliflozin
11333438|NCT03514641|OG001|Outcome|Effect on Mean Ambulatory DBP|Effect on ABPM DBP after 12, 24, and 36 weeks of cumulative exposure to Bexagliflozin
11333439|NCT03514641|OG000|Outcome|Effect on Seated Office SBP|Effect on seated office SBP after 6, 12, 18, 24, and 36 weeks of cumulative exposure to Bexagliflozin
11333440|NCT03514641|OG001|Outcome|Effect on Seated Office DBP|Effect on seated office DBP after 6, 12, 18, 24, and 36 weeks of cumulative exposure to Bexagliflozin
11333441|NCT03514641|EG000|Reported Event|603A: Bexagliflozin Tablets, 20 mg|Each subject will receive bexagliflozin tablets, 20 mg once daily for 12 weeks.
11333442|NCT03514641|EG001|Reported Event|603A: Placebo Tablets|Each subject will receive placebo (inactive tablet) once daily for 12 weeks.
11333443|NCT03514641|EG002|Reported Event|603B: Bexagliflozin Tablets, 20 mg|Each eligible subject who have completed 603A including two successful 24-h ABPM sessions at 603A baseline and at week 12, and have completed the 12 weeks open labeled bexagliflozin run-in period with a successful 24-h ABPM session at week 12 of 603B, will receive bexagliflozin tablets, 20 mg once daily for 12 weeks.
11333444|NCT03514641|EG003|Reported Event|603B: Placebo Tablets|Each eligible subject who have completed 603A including two successful 24-h ABPM sessions at 603A baseline and at week 12, and have completed the 12 weeks open labeled bexagliflozin run-in period with a successful 24-h ABPM session at week 12 of 603B, will receive placebo tablets (inactive), 20 mg once daily for 12 weeks.
11333445|NCT03514966|BG000|Baseline|Conventional Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
11333446|NCT03514966|BG001|Baseline|Position Change Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
11333447|NCT03514966|BG002|Baseline|Total|Total of all reporting groups
11333448|NCT03514966|FG000|Participant Flow|Conventional Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
11335984|NCT03559218|OG000|Outcome|Standard of Care|"Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care~Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis"
11321462|NCT03314857|BG000|Baseline|Patients With SAPIEN XT THV|Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
11321463|NCT03314857|FG000|Participant Flow|Patients With SAPIEN XT THV|Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
11321464|NCT03314857|OG000|Outcome|Patients With SAPIEN XT THV|Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
11321465|NCT03314857|EG000|Reported Event|Patients With SAPIEN XT THV|Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
11321466|NCT03315104|BG000|Baseline|FLU-IGIV High Dose (450 mL)|"Participants received a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
10827843|NCT00112125|EG001|Reported Event|Treatment (CCM + OMT)|Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
11321467|NCT03315104|BG001|Baseline|FLU-IGIV Low Dose (225 mL)|"Participants received a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321468|NCT03315104|BG002|Baseline|Placebo (500 mL Normal Saline)|"Participants received a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Administered IV as 500 mL of normal saline. Participants also received SOC antiviral treatment for flu.~Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration."
11321469|NCT03315104|BG003|Baseline|Total|Total of all reporting groups
11321470|NCT03315104|FG000|Participant Flow|FLU-IGIV High Dose (450 mL)|"Participants received a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321471|NCT03315104|FG001|Participant Flow|FLU-IGIV Low Dose (225 mL)|"Participants received a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321472|NCT03315104|FG002|Participant Flow|Placebo (500 mL Normal Saline)|"Participants received a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Administered IV as 500 mL of normal saline. Participants also received SOC antiviral treatment for flu.~Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration."
11321473|NCT03315104|OG000|Outcome|FLU-IGIV High Dose (450 mL)|"Participants received a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321474|NCT03315104|OG001|Outcome|FLU-IGIV Low Dose (225 mL)|"Participants received a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321475|NCT03315104|OG002|Outcome|Placebo (500 mL Normal Saline)|"Participants received a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Administered IV as 500 mL of normal saline. Participants also received SOC antiviral treatment for flu.~Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration."
11321476|NCT03315104|EG000|Reported Event|FLU-IGIV High Dose (450 mL)|"Participants received a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321477|NCT03315104|EG001|Reported Event|FLU-IGIV Low Dose (225 mL)|"Participants received a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu.~FLU-IGIV: Single dose, sterile liquid formulation for IV administration."
11321478|NCT03315104|EG002|Reported Event|Placebo (Normal Saline)|"Participants received a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Administered IV as 500 mL of normal saline. Participants also received SOC antiviral treatment for flu.~Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration."
11321479|NCT03315208|BG000|Baseline|Unified Protocol + Treatment As Usual|"Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321480|NCT03315208|BG001|Baseline|Treatment As Usual Alone|"Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321481|NCT03315208|BG002|Baseline|Total|Total of all reporting groups
11321482|NCT03315208|FG000|Participant Flow|Unified Protocol + Treatment As Usual|"Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321483|NCT03315208|FG001|Participant Flow|Treatment As Usual Alone|"Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11333449|NCT03514966|FG001|Participant Flow|Position Change Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group were instructed by the study nurses to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine position, left lateral position, three cycles of prone, left lateral, supine, and right lateral positions, and finally supine position, with a duration of 1 min for each position. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
11321484|NCT03315208|OG000|Outcome|Unified Protocol + Treatment As Usual|"Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321485|NCT03315208|OG001|Outcome|Treatment As Usual Alone|"Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321486|NCT03315208|EG000|Reported Event|Unified Protocol + Treatment As Usual|"Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321487|NCT03315208|EG001|Reported Event|Treatment As Usual Alone|"Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.~Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders."
11321488|NCT03315208|EG002|Reported Event|Not Randomized|Participants in this arm were enrolled and completed the baseline visit but never randomized.
11321489|NCT03315286|BG000|Baseline|Device: SHADE Ultraviolet Sensor|"Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance~SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection.~Standard of care counseling: Patients will use their own method of photo-protection"
11321490|NCT03315286|BG001|Baseline|Standard of Care Counseling|"Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance~Standard of care counseling: Patients will use their own method of photo-protection"
11321491|NCT03315286|BG002|Baseline|Total|Total of all reporting groups
11321492|NCT03315286|FG000|Participant Flow|Device: SHADE Ultraviolet Sensor|"Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance~SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection.~Standard of care counseling: Patients will use their own method of photo-protection"
11321493|NCT03315286|FG001|Participant Flow|Standard of Care Counseling|"Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance~Standard of care counseling: Patients will use their own method of photo-protection"
11321494|NCT03315286|OG000|Outcome|Device: SHADE Ultraviolet Sensor|"Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance~SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection.~Standard of care counseling: Patients will use their own method of photo-protection"
11321495|NCT03315286|OG001|Outcome|Standard of Care Counseling|"Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance~Standard of care counseling: Patients will use their own method of photo-protection"
11321496|NCT03315286|EG000|Reported Event|Device: SHADE Ultraviolet Sensor|"Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance~SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection.~Standard of care counseling: Patients will use their own method of photo-protection"
11321497|NCT03315286|EG001|Reported Event|Standard of Care Counseling|"Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance~Standard of care counseling: Patients will use their own method of photo-protection"
11321498|NCT03315559|BG000|Baseline|All Study Participants|Participants received intravenous (IV) infusion of [14C] radiolabeled GSK2269557 along with a single dose of 10 micrograms (µg) administered as single microtracer, concomitantly with an inhaled non-radiolabeled 1000 µg dose of GSK2269557 in Treatment Period 1. There was a washout of at least 14 days. Participants received [14C]-GSK2269557 with a single dose of 800 µg, administered as an oral solution in Treatment Period 2.
11321499|NCT03315559|FG000|Participant Flow|All Study Participants|Participants received intravenous (IV) infusion of [14C] radiolabeled GSK2269557 along with a single dose of 10 micrograms (µg) administered as single microtracer, concomitantly with an inhaled non-radiolabeled 1000 µg dose of GSK2269557 in Treatment Period 1. There was a washout of at least 14 days. Participants received [14C]-GSK2269557 with a single dose of 800 µg, administered as an oral solution in Treatment Period 2.
11321500|NCT03315559|OG000|Outcome|Nemi IH + 14C-Nemi IV|Participants received IV infusion of [14C] radiolabeled GSK2269557 as a single dose of 10 µg administered as single microtracer, concomitantly with an inhaled non-radiolabeled 1000 µg dose of GSK2269557.
11321501|NCT03315559|OG000|Outcome|14C-Nemi Oral|Participants received [14C]-GSK2269557 as a single dose of 800 µg, administered as an oral solution.
11321502|NCT03315559|OG001|Outcome|14C-Nemi Oral|Participants received solution of [14C] radiolabelled GSK2269557 as a single dose of 800 µg, administered as an oral solution.
11321503|NCT03315559|EG000|Reported Event|Nemi IH + 14C-Nemi IV|Participants received IV infusion of [14C] radiolabeled GSK2269557 as a single dose of 10 µg administered as single microtracer, concomitantly with an inhaled non-radiolabeled 1000 µg dose of GSK2269557.
11321504|NCT03315559|EG001|Reported Event|14C-Nemi Oral|Participants received solution of [14C] radiolabelled GSK2269557 as a single dose of 800 µg orally
11321505|NCT03315572|BG000|Baseline|Pediatric Participants|Pediatric participants with asthma in the age range of 5 to 11 years were included.
11321506|NCT03315572|BG001|Baseline|Caregivers|The parents or legal guardians of participants with asthma were included.
11321507|NCT03315572|BG002|Baseline|Total|Total of all reporting groups
11321508|NCT03315572|FG000|Participant Flow|Pediatric Participants|Pediatric participants with asthma in the age range of 5 to 11 years were included.
11321509|NCT03315572|FG001|Participant Flow|Caregivers|The parents or legal guardians of participants with asthma were included.
11321510|NCT03315572|OG000|Outcome|Pediatric Participants (5 to 7 Years)|Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
11321511|NCT03315572|OG001|Outcome|Pediatric Participants (8 to 11 Years)|Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
11321512|NCT03315572|OG000|Outcome|Caregivers|Caregivers of pediatric participants with asthma were included. Participants were required to complete caregiver version of ease of use items.
11321513|NCT03315572|EG000|Reported Event|Pediatric Participants|Pediatric participants with asthma in the age range of 5 to 11 years were included.
11321514|NCT03315572|EG001|Reported Event|Caregivers|The parents or legal guardians of participants with asthma were included.
11321515|NCT03315689|BG000|Baseline|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily.
11321516|NCT03315689|BG001|Baseline|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily.
11321517|NCT03315689|BG002|Baseline|Total|Total of all reporting groups
11321518|NCT03315689|FG000|Participant Flow|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily.
11321519|NCT03315689|FG001|Participant Flow|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily.
11321520|NCT03315689|OG000|Outcome|Vehicle|"Vehicle~Vehicle: Vehicle Topical Solution"
11321521|NCT03315689|OG001|Outcome|Active|"ATI-50002 Topical Solution~ATI-50002: ATI-50002 Topical Solution"
11321522|NCT03315689|OG000|Outcome|ATI-50002 0.46% Topical Solution OLE|ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
11321523|NCT03315689|EG000|Reported Event|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily during the double blind period of the study.
11321524|NCT03315689|EG001|Reported Event|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study
11321525|NCT03315689|EG002|Reported Event|ATI-50002 0.46% Topical Solution OLE|ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
11321526|NCT03315702|BG000|Baseline|Control／Mechanical Ventilation|"venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cm h2o, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321527|NCT03315702|FG000|Participant Flow|Control／Mechanical Ventilation|venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation
11321528|NCT03315702|OG000|Outcome|Control／Mechanical Ventilation|"Venous blood samples collected from patients twice before mechanical ventilation and 3rd hour after~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321529|NCT03315702|OG000|Outcome|Control／Mechanical Ventilation|venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation
11321530|NCT03315702|EG000|Reported Event|Control／Mechanical Ventilation|Venous blood samples were collected twice for each patient，relatively before onset of mechanical ventilation and 3rd hour after mechanical ventilation.
11321531|NCT03315780|BG000|Baseline|Overall|Participants were randomized to one of two treatment sequences: Dulaglutide 0.75 mg administered subcutaneously (SC) in Period 1 and placebo administered SC in Period 2 or placebo administered SC in Period 1 and Dulaglutide 0.75 mg administered in Period 2.
11321532|NCT03315780|FG000|Participant Flow|Dulaglutide Then Placebo|"Dulaglutide 0.75 milligrams (mg) administered subcutaneously (SC) once weekly for 4 weeks in Period 1 followed by placebo administered SC once weekly for 4 weeks in period 2.~There is a 4 to 6 week washout period between Period 1 and Period 2."
11321533|NCT03315780|FG001|Participant Flow|Placebo Then Dulaglutide|"Placebo administered SC once weekly for 4 weeks in Period 1 followed byDulaglutide 0.75 mg administered SC once weekly for 4 weeks in Period 2.~There is a 4 to 6 week washout period between Period 1 and Period 2."
11321534|NCT03315780|OG000|Outcome|Dulaglutide|Dulaglutide 0.75 mg administered SC once weekly for four weeks.
11321535|NCT03315780|OG001|Outcome|Placebo|Placebo administered SC once weekly for four weeks.
11321536|NCT03315780|EG000|Reported Event|Dulaglutide|Dulaglutide 0.75 mg administered SC once weekly for four weeks.
11321537|NCT03315780|EG001|Reported Event|Placebo|Placebo administered SC once weekly for four weeks.
11321538|NCT03315793|BG000|Baseline|Duloxetine|20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses Duloxetine were administered for 1 week during tapering off period.
11321539|NCT03315793|BG001|Baseline|Placebo|Placebo was administered every day for 7 weeks.
11321540|NCT03315793|BG002|Baseline|Total|Total of all reporting groups
11321541|NCT03315793|FG000|Participant Flow|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
11321542|NCT03315793|FG001|Participant Flow|Placebo|Placebo was administered every day for 7 weeks.
11321543|NCT03315793|OG000|Outcome|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
11321544|NCT03315793|OG001|Outcome|Placebo|Placebo was administered every day for 7 weeks.
11321545|NCT03315793|OG000|Outcome|Duloxetine|20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses Duloxetine were administered for 1 week during tapering off period.
11321546|NCT03315793|OG000|Outcome|Duloxetine|20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
11321547|NCT03315793|EG000|Reported Event|Duloxetine|"20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks.~Lower doses of Duloxetine were administered for 1 week during tapering off period."
11321548|NCT03315793|EG001|Reported Event|Placebo|Placebo was administered every day for 7 weeks.
11321549|NCT03315949|BG000|Baseline|Same-day Dose Group|"Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321550|NCT03315949|BG001|Baseline|Split-dose Group|"Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321551|NCT03315949|BG002|Baseline|Total|Total of all reporting groups
11321552|NCT03315949|FG000|Participant Flow|Same-day Dose Group|"Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321553|NCT03315949|FG001|Participant Flow|Split-dose Group|"Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321554|NCT03315949|OG000|Outcome|Same-day Dose Group|"Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321555|NCT03315949|OG001|Outcome|Split-dose Group|"Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321556|NCT03315949|EG000|Reported Event|Same-day Dose Group|"Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321557|NCT03315949|EG001|Reported Event|Split-dose Group|"Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.~Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser.~Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy"
11321558|NCT03316131|BG000|Baseline|All Subjects|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + 10 mg dapagliflozin/placebo. Each patient randomized to treatment A in period 1 received Treatment B in period 2 and each patient randomized to treatment B in period 1 received Treatment A in period 2
11321559|NCT03316131|FG000|Participant Flow|Treatment Sequence A+B|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + 10 mg dapagliflozin (Treatment A). Each patient randomized to treatment A in period 1 received Treatment B in period 2 as this is 2-way crossover study
11321560|NCT03316131|FG001|Participant Flow|Treatment Sequence B+A|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + placebo (Treatment B). Each patient randomized to treatment B in period 1 received Treatment A in period 2 as this is 2-way crossover study
11321561|NCT03316131|OG000|Outcome|Treatment Sequence A+B|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + 10 mg dapagliflozin (Treatment A). Each patient randomized to treatment A in period 1 received Treatment B in period 2 as this is 2-way crossover study
11321562|NCT03316131|OG001|Outcome|Treatment Sequence B+A|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + placebo (Treatment B). Each patient randomized to treatment B in period 1 received Treatment A in period 2 as this is 2-way crossover study
11321563|NCT03316131|EG000|Reported Event|Treatment Sequence A+B|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + 10 mg dapagliflozin (Treatment A). Each patient randomized to treatment A in period 1 received Treatment B in period 2 as this is 2-way crossover study
11321564|NCT03316131|EG001|Reported Event|Treatment Sequence B+A|Each patient received orally once daily dose of 9 mg verinurad + 80 mg febuxostat + placebo (Treatment B). Each patient randomized to treatment B in period 1 received Treatment A in period 2 as this is 2-way crossover study
11321565|NCT03316170|BG000|Baseline|Social Support + NRT Sampling|"The treatment group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~a brief phone consult (10-15 minutes via phone) germane to smoking cessation,~a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and~a free, 2-week supply of nicotine patches and lozenges delivered via mail.~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.~NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail."
11321566|NCT03316170|BG001|Baseline|Social Support|"The control group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail."
11321567|NCT03316170|BG002|Baseline|Total|Total of all reporting groups
11321568|NCT03316170|FG000|Participant Flow|Social Support + NRT Sampling|"The treatment group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~a brief phone consult (10-15 minutes via phone) germane to smoking cessation,~a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and~a free, 2-week supply of nicotine patches and lozenges delivered via mail.~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.~NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail."
11321569|NCT03316170|FG001|Participant Flow|Social Support|"The control group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail."
11321570|NCT03316170|OG000|Outcome|All Individuals Contacted|All individuals who were contacted about the study.
11321571|NCT03316170|OG000|Outcome|Social Support + NRT Sampling|"The treatment group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~a brief phone consult (10-15 minutes via phone) germane to smoking cessation,~a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and~a free, 2-week supply of nicotine patches and lozenges delivered via mail.~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.~NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail."
11321572|NCT03316170|OG001|Outcome|Social Support|"The control group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail."
11333450|NCT03514966|OG000|Outcome|Conventional Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
11321573|NCT03316170|EG000|Reported Event|Social Support + NRT Sampling|"The treatment group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~a brief phone consult (10-15 minutes via phone) germane to smoking cessation,~a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and~a free, 2-week supply of nicotine patches and lozenges delivered via mail.~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.~NRT Sampling: A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail."
11321574|NCT03316170|EG001|Reported Event|Social Support|"The control group will receive:~a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,~a written directory of a range of social support resources delivered via mail,~Social Support: A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail."
11321575|NCT03316378|BG000|Baseline|Group With Achilles Tendinopathy|"Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.~Ropivacaine injection: single dose, subcutaneous injection"
11321576|NCT03316378|BG001|Baseline|Group Without Achilles Tendinopathy|This group did not receive an injection prior to repeating the set of tests within session.
11321577|NCT03316378|BG002|Baseline|Total|Total of all reporting groups
11321578|NCT03316378|FG000|Participant Flow|Group With Achilles Tendinopathy|"Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.~Ropivacaine injection: single dose, subcutaneous injection"
11321579|NCT03316378|FG001|Participant Flow|Group Without Achilles Tendinopathy|This group had no injection prior to repeating tests within session.
11321580|NCT03316378|OG000|Outcome|Group With Achilles Tendinopathy|"Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.~Ropivacaine injection: single dose, subcutaneous injection"
11321581|NCT03316378|OG001|Outcome|Group Without Achilles Tendinopathy|This group did not receive an injection prior to repeating the set of tests within session.
11321582|NCT03316378|OG001|Outcome|Group Without Achilles Tendinopathy|The control group did not receive any injection between repetitions
11321583|NCT03316378|EG000|Reported Event|Group With Achilles Tendinopathy|"Ropivacaine injection. While looking at the Achilles tendon with ultrasound, the orthopaedic physician will inject 4 mL of 0.5% ropivacaine (numbing medicine) around the area of pain. The needle may be directed just under the skin (and above the tendon) and/or deep to the tendon.~Ropivacaine injection: single dose, subcutaneous injection"
11321584|NCT03316378|EG001|Reported Event|Group Without Achilles Tendinopathy|The control group did not receive an injection between test repetitions
11321585|NCT03316547|BG000|Baseline|Control|The control group received standard hospital care.
11321586|NCT03316547|BG001|Baseline|Intervention|"Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.~SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant."
11321587|NCT03316547|BG002|Baseline|Total|Total of all reporting groups
11321588|NCT03316547|FG000|Participant Flow|Control|The control group received standard hospital care.
11321589|NCT03316547|FG001|Participant Flow|Intervention|"Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.~SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant."
11321590|NCT03316547|OG000|Outcome|Control|The control group received standard hospital care.
11333451|NCT03514966|OG001|Outcome|Position Change Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
11335985|NCT03559218|OG001|Outcome|KeraStat Cream|"Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.~KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin."
11321591|NCT03316547|OG001|Outcome|Intervention|"Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.~SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant."
11321592|NCT03316547|OG000|Outcome|Control|"The control group received standard hospital care.~N = 39"
11321593|NCT03316547|OG001|Outcome|Intervention|"Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.~SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.~N = 31"
11321594|NCT03316547|EG000|Reported Event|Control|The control group received standard hospital care.
11321595|NCT03316547|EG001|Reported Event|Intervention|"Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.~SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant."
11321596|NCT03316911|BG000|Baseline|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11321597|NCT03316911|BG001|Baseline|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11321598|NCT03316911|BG002|Baseline|Total|Total of all reporting groups
11321599|NCT03316911|FG000|Participant Flow|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11321600|NCT03316911|FG001|Participant Flow|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11321601|NCT03316911|OG000|Outcome|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11321602|NCT03316911|OG001|Outcome|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11321603|NCT03316911|EG000|Reported Event|MKit WebApp Intervention|"The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.~MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources."
11321604|NCT03316911|EG001|Reported Event|Standard of Care|The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.
11321605|NCT03316976|BG000|Baseline|Group 1: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321606|NCT03316976|BG001|Baseline|Group 2: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321607|NCT03316976|BG002|Baseline|Total|Total of all reporting groups
11321608|NCT03316976|FG000|Participant Flow|Group 1: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321609|NCT03316976|FG001|Participant Flow|Group 2: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321610|NCT03316976|OG000|Outcome|Group 1: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321611|NCT03316976|OG001|Outcome|Group 2: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321612|NCT03316976|EG000|Reported Event|Group 1: Dexlansoprazole 30 mg|Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321613|NCT03316976|EG001|Reported Event|Group 2: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
11321614|NCT03317002|BG000|Baseline|AZD5718 (200 mg)|AZD5718 (200 mg)
11321615|NCT03317002|BG001|Baseline|AZD5718 (50 mg)|AZD5718 (50 mg)
11321616|NCT03317002|BG002|Baseline|Placebo|Placebo
11321617|NCT03317002|BG003|Baseline|Total|Total of all reporting groups
11321618|NCT03317002|FG000|Participant Flow|AZD5718 (200 mg)|AZD5718 (200 mg)
11321619|NCT03317002|FG001|Participant Flow|AZD5718 (50 mg)|AZD5718 (50 mg)
11321620|NCT03317002|FG002|Participant Flow|Placebo|Placebo
11321621|NCT03317002|OG000|Outcome|AZD5718 (200 mg)|AZD5718 (200 mg)
11321622|NCT03317002|OG001|Outcome|AZD5718 (50 mg)|AZD5718 (50 mg)
11321623|NCT03317002|OG002|Outcome|Placebo|Placebo
11321624|NCT03317002|EG000|Reported Event|AZD5718 (200 mg)|AZD5718 (200 mg)
11321625|NCT03317002|EG001|Reported Event|AZD5718 (50 mg)|AZD5718 (50 mg)
11321626|NCT03317002|EG002|Reported Event|Placebo|Placebo
11321627|NCT03317288|BG000|Baseline|SCI Subjects|"The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.~Dabir Air overlay: The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table."
11321628|NCT03317288|FG000|Participant Flow|SCI Subjects|"The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.~Dabir Air overlay: The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table."
11321629|NCT03317288|OG000|Outcome|Alternating Pressure -- Inflation Cycle|Averaged skin blood flow during the inflation cycle of the alternating pressure
11321630|NCT03317288|OG001|Outcome|Alternating Pressure -- Deflation Cycle|Averaged skin blood flow during the deflation cycle of the alternating pressure
11321631|NCT03317288|OG002|Outcome|Control (Operating Room Pad Only)|Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
11321632|NCT03317288|OG000|Outcome|Alternating Pressure -- Inflation Cycle|Averaged peak interface pressure during the inflation cycle of the alternating pressure
11321633|NCT03317288|OG001|Outcome|Alternating Pressure -- Deflation Cycle|Averaged peak interface pressure during the deflation cycle of the alternating pressure
11321634|NCT03317288|OG002|Outcome|Control (Operating Room Pad Only)|Averaged peak interface pressure during supine lying on the operating room pad only (without alternating pressure overlay)
11321635|NCT03317288|OG000|Outcome|Alternating Pressure -- Inflation Cycle|Averaged interface pressure during the inflation cycle of the alternating pressure
11321636|NCT03317288|OG001|Outcome|Alternating Pressure -- Deflation Cycle|Averaged interface pressure during the deflation cycle of the alternating pressure
11321637|NCT03317288|OG002|Outcome|Control (Operating Room Pad Only)|Averaged interface pressure during supine lying on the operating room pad only (without alternating pressure overlay)
11321638|NCT03317288|OG000|Outcome|Post Alternating Pressure|Averaged skin blood flow during supine lying after lying on operating room pad with alternating pressure
11321639|NCT03317288|OG001|Outcome|Control|Averaged skin blood flow during supine lying after operating room pad only
11321640|NCT03317288|OG000|Outcome|Post Alternating Pressure|Averaged peak interface pressure during supine lying after lying on operating room pad with alternating pressure
11321641|NCT03317288|OG001|Outcome|Control|Averaged peak interface pressure during supine lying after operating room pad only
11321642|NCT03317288|OG000|Outcome|Post Alternating Pressure|Averaged interface pressure during supine lying after lying on operating room pad with alternating pressure
11321643|NCT03317288|OG001|Outcome|Control|Averaged interface pressure during supine lying after operating room pad only
11321644|NCT03317288|EG000|Reported Event|SCI Subjects|"The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.~Dabir Air overlay: The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table."
11321645|NCT03317379|BG000|Baseline|Peer Mentorship|"Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.~Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.~Recovery Record use with mentor: Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors."
11321646|NCT03317379|BG001|Baseline|Social Support Mentorship|"Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.~Social support mentorship: Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work)."
11321647|NCT03317379|BG002|Baseline|Wait List|Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
11321648|NCT03317379|BG003|Baseline|Total|Total of all reporting groups
11321649|NCT03317379|FG000|Participant Flow|Peer Mentorship|"Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.~Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.~Recovery Record use with mentor: Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors."
11321650|NCT03317379|FG001|Participant Flow|Social Support Mentorship|"Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.~Social support mentorship: Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work)."
11321651|NCT03317379|FG002|Participant Flow|Wait List|Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
10827844|NCT00112151|BG000|Baseline|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
10827845|NCT00112151|BG001|Baseline|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
11321652|NCT03317379|OG000|Outcome|Peer Mentorship|"Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.~Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.~Recovery Record use with mentor: Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors."
11321653|NCT03317379|OG001|Outcome|Social Support Mentorship|"Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.~Social support mentorship: Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work)."
11321654|NCT03317379|OG002|Outcome|Wait List|Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
10827846|NCT00112151|BG002|Baseline|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
10827847|NCT00112151|BG003|Baseline|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
10827848|NCT00112151|BG004|Baseline|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
11321655|NCT03317379|EG000|Reported Event|Peer Mentorship|"Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.~Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.~Recovery Record use with mentor: Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors."
11321656|NCT03317379|EG001|Reported Event|Social Support Mentorship|"Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.~Social support mentorship: Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work)."
11321657|NCT03317379|EG002|Reported Event|Wait List|Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
11321658|NCT03317431|BG000|Baseline|Ventilation|"patients undergoing selective operation with general anesthesia(GA) and mechanical ventilation(MV)~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321659|NCT03317431|FG000|Participant Flow|Ventilation|"patients undergoing selective operation with general anesthesia(GA) and mechanical ventilation(MV)~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321660|NCT03317431|OG000|Outcome|Ventilation|"patients undergoing selective operation with general anesthesia(GA) and mechanical ventilation(MV)~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321661|NCT03317431|EG000|Reported Event|Ventilation|"patients undergoing selective operation with general anesthesia(GA) and mechanical ventilation(MV)~mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
11321662|NCT03317444|BG000|Baseline|TRC101 Treatment Arm|The first dose of blinded study drug (2 packets for a total of 6 g TRC101) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
10827849|NCT00112151|BG005|Baseline|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
11321663|NCT03317444|BG001|Baseline|Placebo Treatment Arm|The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321664|NCT03317444|BG002|Baseline|Total|Total of all reporting groups
11321665|NCT03317444|FG000|Participant Flow|TRC101 Treatment Arm|The first dose of blinded study drug (2 packets for a total of 6 g TRC101) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321666|NCT03317444|FG001|Participant Flow|Placebo Treatment Arm|The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321667|NCT03317444|OG000|Outcome|TRC101 Treatment Arm|The first dose of blinded study drug (2 packets for a total of 6 g TRC101) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321668|NCT03317444|OG001|Outcome|Placebo Treatment Arm|The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321669|NCT03317444|EG000|Reported Event|TRC101 Treatment Arm|The first dose of blinded study drug (2 packets of TRC101 [6 g]) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321670|NCT03317444|EG001|Reported Event|Placebo Treatment Arm|The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E.
11321671|NCT03318315|BG000|Baseline|Group 1 Simultaneous Administration|3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
11321672|NCT03318315|BG001|Baseline|Group 2 Sequential Administration|0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
11321673|NCT03318315|BG002|Baseline|Group 3 IIV4 Only|0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
11321674|NCT03318315|BG003|Baseline|Total|Total of all reporting groups
11321675|NCT03318315|FG000|Participant Flow|Group 1 Simultaneous Administration|3.75 mcg HA per 0.5 mL dose of Monovalent 2017 H7N9 inactivated influenza vaccine in Phosphate Buffered Saline (PBS) diluent + GSK AS03 adjuvant and 0.5 ml dose of seasonal quadrivalent inactivated influenza vaccine (IIV4), both administered intramuscularly within 15 minutes on Day 1, and 3.75 mcg HA per 0.5 mL dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22
11321676|NCT03318315|FG001|Participant Flow|Group 2 Sequential Administration|0.5 ml dose of IIV4 vaccine intramuscularly on day 1 and 3.75 mcg HA per 0.5 ml dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22 and Day 43
11321677|NCT03318315|FG002|Participant Flow|Group 3 IIV4 Only|0.5 ml dose of IIV4 vaccine intramuscularly on Day 1, n=30
11321678|NCT03318315|OG000|Outcome|Group 1 Simultaneous Administration|3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
11321679|NCT03318315|OG001|Outcome|Group 2 Sequential Administration|0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
11321680|NCT03318315|OG002|Outcome|Group 3 IIV4 Only|0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
11321681|NCT03318315|OG000|Outcome|Group 2 Sequential Administration|0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
11321682|NCT03318315|EG000|Reported Event|Group 1 Simultaneous Administration|3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
11321683|NCT03318315|EG001|Reported Event|Group 2 Sequential Administration|0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
11321684|NCT03318315|EG002|Reported Event|Group 3 IIV4 Only|0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
11321685|NCT03318341|BG000|Baseline|Real Then Sham|"Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.~Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level.~Sham Stimulation: The device applies no vibration."
11321686|NCT03318341|BG001|Baseline|Sham Then Real|"Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies no stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.~Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level.~Sham Stimulation: The device applies no vibration."
11321687|NCT03318341|BG002|Baseline|Total|Total of all reporting groups
11321688|NCT03318341|FG000|Participant Flow|Real Then Sham|"Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.~Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level.~Sham Stimulation: The device applies no vibration."
11321689|NCT03318341|FG001|Participant Flow|Sham Then Real|"Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies no stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.~Real Stimulation: The device applies wrist vibration at a subthreshold (imperceptible) level.~Sham Stimulation: The device applies no vibration."
11321690|NCT03318341|OG000|Outcome|Real Then Sham|Receive real stimulation for 1 month, then sham stimulation for 1 month.
11321691|NCT03318341|OG001|Outcome|Sham Then Real|Receive sham stimulation for 1 month, then real stimulation for 1 month.
11321692|NCT03318341|EG000|Reported Event|Real Then Sham - Month 1 (Real)|Receive real stimulation for month 1
11321693|NCT03318341|EG001|Reported Event|Sham Then Real - Month 1 (Sham)|Receive sham stimulation for month 1
11321694|NCT03318341|EG002|Reported Event|Real Then Sham - Month 2 (Sham)|Receive sham stimulation for month 2.
11321695|NCT03318341|EG003|Reported Event|Sham Then Real - Month 2 (Real)|Receive real stimulation month 2.
11321696|NCT03318783|BG000|Baseline|GSK2256294|"10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.~GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days."
11321697|NCT03318783|BG001|Baseline|Placebo|"10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.~Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days."
11321698|NCT03318783|BG002|Baseline|Total|Total of all reporting groups
11321699|NCT03318783|FG000|Participant Flow|GSK2256294|"10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.~GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days."
11321700|NCT03318783|FG001|Participant Flow|Placebo|"10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.~Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days."
11321701|NCT03318783|OG000|Outcome|GSK2256294|"10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.~GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days."
11321702|NCT03318783|OG001|Outcome|Placebo|"10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.~Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days."
11321703|NCT03318783|EG000|Reported Event|GSK2256294|"10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.~GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days."
11321704|NCT03318783|EG001|Reported Event|Placebo|"10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.~Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days."
11321705|NCT03319134|BG000|Baseline|Active Anodal HD-tDCS|Active anodal HD-tDCS stimulation applied during memory task
11321706|NCT03319134|BG001|Baseline|Sham HD-tDCS|Sham HD-tDCS stimulation during memory task for comparison
11321707|NCT03319134|BG002|Baseline|Active Cathodal HD-tDCS|Active cathodal HD-tDCS stimulation applied during memory task
11321708|NCT03319134|BG003|Baseline|Total|Total of all reporting groups
11321709|NCT03319134|FG000|Participant Flow|Active Anodal HD-tDCS|Active anodal HD-tDCS stimulation applied during memory task
11321710|NCT03319134|FG001|Participant Flow|Sham HD-tDCS|Sham HD-tDCS stimulation during memory task for comparison
11321711|NCT03319134|FG002|Participant Flow|Active Cathodal HD-tDCS|Active cathodal HD-tDCS stimulation applied during memory task
11321712|NCT03319134|OG000|Outcome|Active Anodal HD-tDCS|Active anodal HD-tDCS stimulation applied during memory task
11321713|NCT03319134|OG001|Outcome|Sham HD-tDCS|Sham HD-tDCS stimulation during memory task for comparison
11321714|NCT03319134|OG002|Outcome|Active Cathodal HD-tDCS|Active cathodal HD-tDCS stimulation applied during memory task
11321715|NCT03319134|EG000|Reported Event|Active Anodal HD-tDCS|Active anodal HD-tDCS stimulation applied during memory task
11321716|NCT03319134|EG001|Reported Event|Sham HD-tDCS|Sham HD-tDCS stimulation during memory task for comparison
11321717|NCT03319134|EG002|Reported Event|Active Cathodal HD-tDCS|Active cathodal HD-tDCS stimulation applied during memory task
11321718|NCT03319173|BG000|Baseline|Experimental Group|"Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Dietary intervention: Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation."
11321719|NCT03319173|BG001|Baseline|Control Group|"Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Dietary intervention: Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD)."
11321720|NCT03319173|BG002|Baseline|Total|Total of all reporting groups
11333452|NCT03514966|EG000|Reported Event|Conventional Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCCG examination.
11333453|NCT03514966|EG001|Reported Event|Position Change Group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCCG examination.
11333454|NCT03515681|BG000|Baseline|Intervention|"Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.~Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment."
11321721|NCT03319173|FG000|Participant Flow|Experimental Group|"Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate.~Both groups will play the Advanced PEAK brain training games on mobile devices for 75 minutes per week.~Dietary intervention:Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation.~Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD)."
11321722|NCT03319173|FG001|Participant Flow|Control Group|Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.
11321723|NCT03319173|OG000|Outcome|Experimental Group|MoCA post intervention score
11321724|NCT03319173|OG001|Outcome|Control Group|MoCA post intervention score
11321725|NCT03319173|OG000|Outcome|Experimental Group|Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate.
11321726|NCT03319173|OG001|Outcome|Control Group|Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.
11321727|NCT03319173|OG000|Outcome|Experimental Group|"Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Dietary intervention: Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation."
11321728|NCT03319173|OG001|Outcome|Control Group|"Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Dietary intervention: Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD)."
11321729|NCT03319173|EG000|Reported Event|Experimental Group|"Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Dietary intervention: Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation."
11321730|NCT03319173|EG001|Reported Event|Control Group|"Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.~Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week.~Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD)."
11321731|NCT03319212|BG000|Baseline|Asymptomatic|Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
11321732|NCT03319212|BG001|Baseline|Symptomatic|Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study.
11321733|NCT03319212|BG002|Baseline|Total|Total of all reporting groups
11321734|NCT03319212|FG000|Participant Flow|Asymptomatic|Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
11321735|NCT03319212|FG001|Participant Flow|Symptomatic|Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
11321736|NCT03319212|OG000|Outcome|Asymptomatic|Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
11321737|NCT03319212|OG001|Outcome|Symptomatic|Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
11321738|NCT03319212|EG000|Reported Event|Senofilcon A|All subjects that wore the senofilcon A lens at any point throughout the study.
11321739|NCT03319277|BG000|Baseline|Routine Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.~Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge."
11321740|NCT03319277|BG001|Baseline|Decreased Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.~Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets."
11321741|NCT03319277|BG002|Baseline|Total|Total of all reporting groups
11321742|NCT03319277|FG000|Participant Flow|Routine Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.~Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge."
11321743|NCT03319277|FG001|Participant Flow|Decreased Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.~Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets."
11321744|NCT03319277|OG000|Outcome|Routine Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.~Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge."
11321745|NCT03319277|OG001|Outcome|Decreased Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.~Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets."
11321746|NCT03319277|EG000|Reported Event|Routine Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.~Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge."
11321747|NCT03319277|EG001|Reported Event|Decreased Opiate Prescription|"This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.~Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets."
11321748|NCT03319719|BG000|Baseline|Belotero Balance With or Without Lidocaine|Participants received treatment with Test Product BBL, injection, in one of the two NLF and Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
11321749|NCT03319719|FG000|Participant Flow|Belotero Balance With or Without Lidocaine|Participants received treatment with Test Product belotero balance with lidocaine (BBL), injection, in one of the two nasolabial fold (NLF) and Control Product belotero balance (BB) without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 milliliter (mL) per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
11321750|NCT03319719|OG000|Outcome|Test Product: BBL|Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.
11321751|NCT03319719|OG001|Outcome|Control Product: BB|Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
11321752|NCT03319719|OG000|Outcome|Belotero Balance With or Without Lidocaine|Participants received treatment with Test Product BBL, injection, in one of the two NLF and Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
11333455|NCT03515681|BG001|Baseline|Control|Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).
11333456|NCT03515681|BG002|Baseline|Total|Total of all reporting groups
10827850|NCT00112151|BG006|Baseline|Total|Total of all reporting groups
10827851|NCT00112151|FG000|Participant Flow|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
11321753|NCT03319719|EG000|Reported Event|Belotero Balance With or Without Lidocaine|Participants received treatment with Test Product BBL, injection, in one of the two NLF and Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
11321754|NCT03319810|BG000|Baseline|Infusion of IVIG|Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
11321755|NCT03319810|FG000|Participant Flow|Infusion of IVIG|Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
11321756|NCT03319810|OG000|Outcome|Infusion of IVIG|Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
11321757|NCT03319810|EG000|Reported Event|Infusion of IVIG|Octagam 10%: FDA approved human normal immunoglobulin solution ready for intravenous administration
11321758|NCT03319953|BG000|Baseline|Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics|TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321759|NCT03319953|BG001|Baseline|Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321760|NCT03319953|BG002|Baseline|Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics|TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321761|NCT03319953|BG003|Baseline|Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321762|NCT03319953|BG004|Baseline|Total|Total of all reporting groups
11321763|NCT03319953|FG000|Participant Flow|Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics|TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321764|NCT03319953|FG001|Participant Flow|Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321765|NCT03319953|FG002|Participant Flow|Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics|TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321766|NCT03319953|FG003|Participant Flow|Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321767|NCT03319953|OG000|Outcome|Placebo|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321768|NCT03319953|OG001|Outcome|TAK-041 40 mg|TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321769|NCT03319953|OG002|Outcome|TAK-041 160 mg|TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321770|NCT03319953|EG000|Reported Event|Placebo|TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321771|NCT03319953|EG001|Reported Event|TAK-041 40 mg|TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321772|NCT03319953|EG002|Reported Event|TAK-041 160 mg|TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
11321773|NCT03320057|BG000|Baseline|Medication Abortion Patients|"Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)~Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit"
10827852|NCT00112151|FG001|Participant Flow|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
10827853|NCT00112151|FG002|Participant Flow|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
11321774|NCT03320057|FG000|Participant Flow|Medication Abortion Patients|"Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)~Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit"
11321775|NCT03320057|FG001|Participant Flow|Pharmacist Providing Services at One of the Study Pharmacies During the Study|All pharmacists providing services at one of the study pharmacies during the study were invited to participate in the training on dispensing mifepristone and surveys. Only trained pharmacists were eligible to participate in the endline survey.
11321776|NCT03320057|OG000|Outcome|Pharmacists|Pharmacists providing services at one of the study pharmacies during the study
11321777|NCT03320057|OG000|Outcome|Medication Abortion Patients|"Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)~Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit"
11321778|NCT03320057|EG000|Reported Event|Medication Abortion Patients|"Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)~Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit"
11321779|NCT03320057|EG001|Reported Event|Pharmacists|Pharmacists providing services at one of the study pharmacies during the study and consenting to training
11321780|NCT03320096|BG000|Baseline|Ultherapy Treatment|Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
11321781|NCT03320096|FG000|Participant Flow|Ultherapy Treatment|Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 millimeter (mm) using 7-megahertz (MHz) transducer with 0.30 joules (J) of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
11321782|NCT03320096|OG000|Outcome|Ultherapy Treatment|Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
11321783|NCT03320096|EG000|Reported Event|Ultherapy Treatment|Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
11321784|NCT03320369|BG000|Baseline|Treatment|"Elemental formula Intervention: Elemental Diet Therapy~Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete"
11321785|NCT03320369|FG000|Participant Flow|Treatment|"Elemental formula Intervention: Elemental Diet Therapy~Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete"
11321786|NCT03320369|OG000|Outcome|Treatment|"Elemental formula Intervention: Elemental Diet Therapy~Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete"
11321787|NCT03320369|EG000|Reported Event|Treatment|"Elemental formula Intervention: Elemental Diet Therapy~Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete"
11321788|NCT03320824|BG000|Baseline|New Dermal Filler|"hyaluronic acid~New Dermal Filler: hyaluronic acid"
11321789|NCT03320824|BG001|Baseline|Dermal Filler|"hyaluronic acid~Device: FDA Approved Dermal Filler: hyaluronic acid"
11321790|NCT03320824|BG002|Baseline|Total|Total of all reporting groups
11321791|NCT03320824|FG000|Participant Flow|New Dermal Filler|"hyaluronic acid~New Dermal Filler: hyaluronic acid"
11321792|NCT03320824|FG001|Participant Flow|Dermal Filler|"hyaluronic acid~Device: FDA Approved Dermal Filler: hyaluronic acid"
11321793|NCT03320824|OG000|Outcome|New Dermal Filler|"hyaluronic acid~New Dermal Filler: hyaluronic acid"
11321794|NCT03320824|OG001|Outcome|Dermal Filler|"hyaluronic acid~Device: FDA Approved Dermal Filler: hyaluronic acid"
11321795|NCT03320824|EG000|Reported Event|New Dermal Filler|"hyaluronic acid~New Dermal Filler: hyaluronic acid"
11321796|NCT03320824|EG001|Reported Event|Dermal Filler|"hyaluronic acid~Device: FDA Approved Dermal Filler: hyaluronic acid"
11321797|NCT03320850|BG000|Baseline|Stage 1: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321798|NCT03320850|BG001|Baseline|Stage 1: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321799|NCT03320850|BG002|Baseline|Stage 1: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321800|NCT03320850|BG003|Baseline|Stage 1: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321801|NCT03320850|BG004|Baseline|Stage 1: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321802|NCT03320850|BG005|Baseline|Stage 2: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321803|NCT03320850|BG006|Baseline|Stage 2: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321804|NCT03320850|BG007|Baseline|Stage 2: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321805|NCT03320850|BG008|Baseline|Stage 2: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321806|NCT03320850|BG009|Baseline|Stage 2: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321807|NCT03320850|BG010|Baseline|Total|Total of all reporting groups
11321808|NCT03320850|FG000|Participant Flow|Stage 1: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321809|NCT03320850|FG001|Participant Flow|Stage 1: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321810|NCT03320850|FG002|Participant Flow|Stage 1: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321811|NCT03320850|FG003|Participant Flow|Stage 1: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321812|NCT03320850|FG004|Participant Flow|Stage 1: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321813|NCT03320850|FG005|Participant Flow|Stage 2: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321814|NCT03320850|FG006|Participant Flow|Stage 2: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321815|NCT03320850|FG007|Participant Flow|Stage 2: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321816|NCT03320850|FG008|Participant Flow|Stage 2: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321817|NCT03320850|FG009|Participant Flow|Stage 2: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321818|NCT03320850|OG000|Outcome|Stage 2: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321819|NCT03320850|OG001|Outcome|Stage 2: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321820|NCT03320850|OG002|Outcome|Stage 2: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321821|NCT03320850|OG003|Outcome|Stage 2: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321822|NCT03320850|OG004|Outcome|Stage 2: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321823|NCT03320850|OG000|Outcome|Stage 1: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321824|NCT03320850|OG001|Outcome|Stage 1: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321825|NCT03320850|OG002|Outcome|Stage 1: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321826|NCT03320850|OG003|Outcome|Stage 1: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321827|NCT03320850|OG004|Outcome|Stage 1: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321828|NCT03320850|OG005|Outcome|Stage 2: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321829|NCT03320850|OG006|Outcome|Stage 2: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321830|NCT03320850|OG007|Outcome|Stage 2: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321831|NCT03320850|OG008|Outcome|Stage 2: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321832|NCT03320850|OG009|Outcome|Stage 2: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321833|NCT03320850|EG000|Reported Event|Stage 1: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321834|NCT03320850|EG001|Reported Event|Stage 1: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321835|NCT03320850|EG002|Reported Event|Stage 1: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321836|NCT03320850|EG003|Reported Event|Stage 1: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321837|NCT03320850|EG004|Reported Event|Stage 1: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321838|NCT03320850|EG005|Reported Event|Stage 2: Placebo + Hydrogel Admixture|BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321839|NCT03320850|EG006|Reported Event|Stage 2: BOTOX® 100U + Hydrogel Admixture|BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321840|NCT03320850|EG007|Reported Event|Stage 2: BOTOX® 300U + Hydrogel Admixture|BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321841|NCT03320850|EG008|Reported Event|Stage 2: BOTOX® 400U + Hydrogel Admixture|BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321842|NCT03320850|EG009|Reported Event|Stage 2: BOTOX® 500U + Hydrogel Admixture|BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
11321843|NCT03320941|BG000|Baseline|LIK066 2.5mg qd|Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
11321844|NCT03320941|BG001|Baseline|LIK066 10mg qd|Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
11321845|NCT03320941|BG002|Baseline|LIK066 25 mg qd|Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
11321846|NCT03320941|BG003|Baseline|LIK066 50 mg qd|Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
11321847|NCT03320941|BG004|Baseline|Placebo|Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
11321848|NCT03320941|BG005|Baseline|Total|Total of all reporting groups
11321849|NCT03320941|FG000|Participant Flow|LIK066 2.5mg qd|Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
11321850|NCT03320941|FG001|Participant Flow|LIK066 10mg qd|Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
11321851|NCT03320941|FG002|Participant Flow|LIK066 25 mg qd|Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
11321852|NCT03320941|FG003|Participant Flow|LIK066 50 mg qd|Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
11321853|NCT03320941|FG004|Participant Flow|Placebo|Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
11321854|NCT03320941|OG000|Outcome|LIK066 2.5mg qd|Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
11321855|NCT03320941|OG001|Outcome|LIK066 10mg qd|Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
11321856|NCT03320941|OG002|Outcome|LIK066 25 mg qd|Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
11321857|NCT03320941|OG003|Outcome|LIK066 50 mg qd|Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
11321858|NCT03320941|OG004|Outcome|Placebo|Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
11321859|NCT03320941|EG000|Reported Event|LIK066 2.5mg qd|Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
11321860|NCT03320941|EG001|Reported Event|LIK066 10mg qd|Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
11321861|NCT03320941|EG002|Reported Event|LIK066 25mg qd|Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
11321862|NCT03320941|EG003|Reported Event|LIK066 50mg qd|Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
11321863|NCT03320941|EG004|Reported Event|Placebo|Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
11321864|NCT03321006|BG000|Baseline|Antidepressant (AD) + Full Amplification Hearing Aids|"Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.~Phonak Audeo B-R 90 hearing aid device (Active): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study."
11321865|NCT03321006|BG001|Baseline|Antidepressant (AD) + Low Amplification (Sham) Hearing Aids|"Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.~Audeo B-R 90 hearing aid device (Sham): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies"
11321866|NCT03321006|BG002|Baseline|Total|Total of all reporting groups
11321867|NCT03321006|FG000|Participant Flow|Antidepressant (AD) + Low Amplification (Sham) Hearing Aids|"Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.~Audeo B-R 90 hearing aid device (Sham): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies"
11321868|NCT03321006|FG001|Participant Flow|Antidepressant (AD) + Full Amplification Hearing Aids|"Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.~Phonak Audeo B-R 90 hearing aid device (Active): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study."
11321869|NCT03321006|OG000|Outcome|Antidepressant (AD) + Low Amplification (Sham) Hearing Aids|"Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.~Audeo B-R 90 hearing aid device (Sham): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies"
11321870|NCT03321006|OG001|Outcome|Antidepressant (AD) + Full Amplification Hearing Aids|"Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.~Phonak Audeo B-R 90 hearing aid device (Active): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study."
11321871|NCT03321006|EG000|Reported Event|Antidepressant (AD) + Low Amplification (Sham) Hearing Aids|"Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.~Audeo B-R 90 hearing aid device (Sham): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies"
11333457|NCT03515681|FG000|Participant Flow|Intervention|"Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.~Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment."
11333458|NCT03515681|FG001|Participant Flow|Control|Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).
10827854|NCT00112151|FG003|Participant Flow|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
10827855|NCT00112151|FG004|Participant Flow|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
10827856|NCT00112151|FG005|Participant Flow|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
10827857|NCT00112151|OG000|Outcome|Placebo + No PRT|Placebo gel; no exercise
10827858|NCT00112151|OG001|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
10827859|NCT00112151|OG002|Outcome|Any T + No PRT|T gel supplementation (lower or higher-range); no exercise
10827860|NCT00112151|OG003|Outcome|Any T + PRT|T gel supplementation (lower or higher-range) plus progressive resistance training
10827861|NCT00112151|OG002|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
10827862|NCT00112151|OG003|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
10827863|NCT00112151|EG000|Reported Event|Placebo|Placebo gel with or without progressive resistance training
10827864|NCT00112151|EG001|Reported Event|Lower-range T|T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
10827865|NCT00112151|EG002|Reported Event|Higher-range T|T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
10827866|NCT00112242|BG000|Baseline|Single Peptide Vaccination|"Montanide + Melan-A analogue peptide~Montanide + Melan-A analogue peptide: 1 ml Montanide+ 500 mcg Melan-A analog peptide"
10827867|NCT00112242|BG001|Baseline|Peptide Combination Vaccination|"Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide~Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide"
10827868|NCT00112242|BG002|Baseline|Peptide Combination Vaccination + CpG|"Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide~Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide + 500 mcg Mage10 peptide"
10827869|NCT00112242|BG003|Baseline|Native and Analog Peptide Combination Vaccination + CpG|"Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide~Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide"
11321872|NCT03321006|EG001|Reported Event|Antidepressant (AD) + Full Amplification Hearing Aids|"Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.~Phonak Audeo B-R 90 hearing aid device (Active): Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice~Duloxetine or escitalopram: We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study."
11321873|NCT03321097|BG000|Baseline|Condensed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks.~condensed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321874|NCT03321097|BG001|Baseline|Distributed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks.~distributed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 2 sessions per week, for 12 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321875|NCT03321097|BG002|Baseline|Total|Total of all reporting groups
11321876|NCT03321097|FG000|Participant Flow|Condensed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks.~condensed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321877|NCT03321097|FG001|Participant Flow|Distributed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks.~distributed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321878|NCT03321097|OG000|Outcome|Condensed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks.~condensed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321879|NCT03321097|OG001|Outcome|Distributed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks.~distributed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11333459|NCT03515681|OG000|Outcome|Intervention|"Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.~Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment."
11333460|NCT03515681|OG001|Outcome|Control|Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).
11335986|NCT03559218|EG000|Reported Event|Standard of Care|"Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care~Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis"
11321880|NCT03321097|EG000|Reported Event|Condensed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks.~condensed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321881|NCT03321097|EG001|Reported Event|Distributed RT Group|"Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks.~distributed RT group: BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 2 sessions per week, for 12 weeks.~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
11321882|NCT03321253|BG000|Baseline|Nd: YAG Laser Posterior Capsulotomy|"Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months~Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy"
11321883|NCT03321253|FG000|Participant Flow|Nd: YAG Laser Posterior Capsulotomy|"Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months~Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy"
11321884|NCT03321253|OG000|Outcome|Nd: YAG Laser Posterior Capsulotomy|"Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months~Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy"
11321885|NCT03321253|EG000|Reported Event|Nd: YAG Laser Posterior Capsulotomy|"Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months~Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy"
11321886|NCT03321396|BG000|Baseline|Endoscopic Submucosal Dissection|"All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.~Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as Gut Guarding Gel."
11321887|NCT03321396|FG000|Participant Flow|Endoscopic Submucosal Dissection|"All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.~Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as Gut Guarding Gel."
11321888|NCT03321396|OG000|Outcome|Endoscopic Submucosal Dissection|"All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.~Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as Gut Guarding Gel."
11321889|NCT03321396|EG000|Reported Event|Endoscopic Submucosal Dissection|"All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.~Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as Gut Guarding Gel."
11321890|NCT03321721|BG000|Baseline|Conservative|Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
11321891|NCT03321721|BG001|Baseline|Suture (Absorbable)|Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material
11321892|NCT03321721|BG002|Baseline|Suture (Non-Absorbable)|Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
11321893|NCT03321721|BG003|Baseline|Total|Total of all reporting groups
11321894|NCT03321721|FG000|Participant Flow|Conservative|Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
11321895|NCT03321721|FG001|Participant Flow|Suture-Non Absorbable|Patient fulfilling entry criteria will be randomized to the suture arm for repair with non-absorbable (nylon) suture material
11321896|NCT03321721|FG002|Participant Flow|Suture-Absorbable|Patient fulfilling entry criteria will be randomized to the suture arm for repair with absorbable) suture material
11321897|NCT03321721|OG000|Outcome|Conservative|Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
11321898|NCT03321721|OG001|Outcome|Suture (Absorbable)|Patient fulfilling entry criteria will be randomized to the absorbable suture arm for repair with absorbable suture material
11321899|NCT03321721|OG002|Outcome|Suture (Non-Absorbable)|Patient fulfilling entry criteria will be randomized to the non-absorbable suture arm for repair with non-absorbable suture material
11321900|NCT03321721|OG001|Outcome|Suture (Absorbable)|Patient fulfilling entry criteria will be randomized to the suture arm for repair with suture material
11321901|NCT03321721|EG000|Reported Event|Conservative|Patient fulfilling entry criteria will be randomized to the conservative arm - no suturing
11321902|NCT03321721|EG001|Reported Event|Suture (Absorbable)|Patient fulfilling entry criteria will be randomized to the suture absorbable arm for repair with absorbable suture material
11321903|NCT03321721|EG002|Reported Event|Suture (Non-Absorbable)|Patient fulfilling entry criteria will be randomized to the suture non-absorbable arm for repair with non-absorbable suture material
11321904|NCT03322423|BG000|Baseline|All Dispensed Subjects|All subjects that were dispensed a study lens.
11321905|NCT03322423|FG000|Participant Flow|Delefilcon A/Nesofilcon A|All subjects that were randomized to receive the delefilcon A lens during the first period of the study and the nesofilcon A lens during the second period of the study.
11321906|NCT03322423|FG001|Participant Flow|Nesofilcon A/Delefilcon A|All subjects that were randomized to receive the nesofilcon A during the first period of the study and the delefilcon A lens during the second period of the study.
11321907|NCT03322423|OG000|Outcome|Delefilcon A|All subjects that wore the delefilcon A lens during either the first or second period of the study.
11321908|NCT03322423|OG001|Outcome|Nesofilcon A|All subjects that wore the nesofilcon A lens during either the first or second period of the study.
11321909|NCT03322423|EG000|Reported Event|Delefilcon A|All subjects that wore the delefilcon A lens during either the first or second period of the study.
11321910|NCT03322423|EG001|Reported Event|Nesofilcon A|All subjects that wore the nesofilcon A lens during either the first or second period of the study.
11321911|NCT03322462|BG000|Baseline|Early Symptomatic AD Subjects|Early Symptomatic AD subjects in the flortaucipir PET scan arm
11321912|NCT03322462|FG000|Participant Flow|Early Symptomatic AD Subjects|Early Symptomatic AD subjects in the flortaucipir PET scan arm
11321913|NCT03322462|OG000|Outcome|Early Symptomatic AD, Eligible for AACG Study|Subjects determined to be eligible for the AACG Study from the flortaucipir PET scan arm.
11321914|NCT03322462|OG001|Outcome|Early Symptomatic AD, Ineligible for AACG Study|Subjects who were not eligible for the AACG Study from the flortaucipir PET scan arm.
11321915|NCT03322462|OG002|Outcome|Early Symptomatic AD (Total)|All subjects with early symptomatic AD from the flortaucipir PET scan arm
11321916|NCT03322462|EG000|Reported Event|Safety Analysis Population|All subjects with early symptomatic AD from the flortaucipir PET scan arm who received one dose of flortaucipir
11321917|NCT03322514|BG000|Baseline|Experimental Group|"10 g of Inulin-Propionate Esters will be administered per day~Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora."
11321918|NCT03322514|BG001|Baseline|Inulin|"10 g of Inulin will be administered per day~Inulin: Inulin"
11321919|NCT03322514|BG002|Baseline|Total|Total of all reporting groups
11321920|NCT03322514|FG000|Participant Flow|Experimental Group|"10 g of Inulin-Propionate Esters will be administered per day~Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora."
11321921|NCT03322514|FG001|Participant Flow|Inulin|"10 g of Inulin will be administered per day~Inulin: Inulin"
11321922|NCT03322514|OG000|Outcome|Experimental Group|10 g of Inulin-Propionate Esters administered per day
11321923|NCT03322514|OG001|Outcome|Inulin|10 g of Inulin administered per day
11321924|NCT03322514|EG000|Reported Event|Experimental Group|"10 g of Inulin-Propionate Esters will be administered per day~Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora."
11321925|NCT03322514|EG001|Reported Event|Inulin|"10 g of Inulin will be administered per day~Inulin: Inulin"
11321926|NCT03322657|BG000|Baseline|Neostigmine With Glycopyrrolate|"Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery~Neostigmine: Neostigmine injection~Glycopyrrolate: Glycopyrrolate injection"
11321927|NCT03322657|BG001|Baseline|Sugammadex|"Sugammadex 4 mg/kg at the end surgery~Sugammadex: Sugammadex injection"
11321928|NCT03322657|BG002|Baseline|Total|Total of all reporting groups
11321929|NCT03322657|FG000|Participant Flow|Neostigmine With Glycopyrrolate|"Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery~Neostigmine: Neostigmine injection~Glycopyrrolate: Glycopyrrolate injection"
11321930|NCT03322657|FG001|Participant Flow|Sugammadex|"Sugammadex 4 mg/kg at the end surgery~Sugammadex: Sugammadex injection"
11321931|NCT03322657|OG000|Outcome|Neostigmine With Glycopyrrolate|"Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery~Neostigmine: Neostigmine injection~Glycopyrrolate: Glycopyrrolate injection"
11321932|NCT03322657|OG001|Outcome|Sugammadex|"Sugammadex 4 mg/kg at the end surgery~Sugammadex: Sugammadex injection"
11321933|NCT03322657|EG000|Reported Event|Neostigmine With Glycopyrrolate|"Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery~Neostigmine: Neostigmine injection~Glycopyrrolate: Glycopyrrolate injection"
11321934|NCT03322657|EG001|Reported Event|Sugammadex|"Sugammadex 4 mg/kg at the end surgery~Sugammadex: Sugammadex injection"
11321935|NCT03322930|BG000|Baseline|Patients With a Diagnosis of Retinitis Pigmentosa|"patients with a diagnosis of retinitis pigmentosa~Rod sensitivity: diagnostic test for rod loss in central retina"
11321936|NCT03322930|BG001|Baseline|Patients With a Diagnosis of Intermediate AMD|"patients with a diagnosis of intermediate AMD~Rod sensitivity: diagnostic test for rod loss in central retina"
11321937|NCT03322930|BG002|Baseline|Total|Total of all reporting groups
11321938|NCT03322930|FG000|Participant Flow|Patients With a Diagnosis of Retinitis Pigmentosa|"patients with a diagnosis of retinitis pigmentosa~Rod sensitivity: diagnostic test for rod loss in central retina"
11321939|NCT03322930|FG001|Participant Flow|Patients With Intermediate Age-related Macular Degeneration|"patients with a diagnosis of intermediate AMD~Rod sensitivity: diagnostic test for rod loss in central retina"
11321940|NCT03322930|OG000|Outcome|Patients With a Diagnosis of Retinitis Pigmentosa|"patients with a diagnosis of retinitis pigmentosa~Rod sensitivity: diagnostic test for rod loss in central retina"
11321941|NCT03322930|OG001|Outcome|Patients With a Diagnosis of Intermediate AMD|"patients with a diagnosis of intermediate AMD~Rod sensitivity: diagnostic test for rod loss in central retina"
11321942|NCT03322930|EG000|Reported Event|Patients With a Diagnosis of Retinitis Pigmentosa|"patients with a diagnosis of retinitis pigmentosa~Rod sensitivity: diagnostic test for rod loss in central retina"
11321943|NCT03322930|EG001|Reported Event|Patients With a Diagnosis of Intermediate AMD|"patients with a diagnosis of intermediate AMD~Rod sensitivity: diagnostic test for rod loss in central retina"
11321944|NCT03323086|BG000|Baseline|Brief Intervention (BI) With Technology Extender|"Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.~Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders"
11321945|NCT03323086|BG001|Baseline|Brochure|"Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.~Brochure: Brochures provided one time"
11321946|NCT03323086|BG002|Baseline|Total|Total of all reporting groups
11321947|NCT03323086|FG000|Participant Flow|Brief Intervention (BI) With Technology Extender|"Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.~Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders"
11321948|NCT03323086|FG001|Participant Flow|Brochure|"Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.~Brochure: Brochures provided one time"
11321949|NCT03323086|OG000|Outcome|Brief Intervention (BI) With Technology Extender|"Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.~Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders"
11321950|NCT03323086|OG001|Outcome|Brochure|"Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.~Brochure: Brochures provided one time"
11321951|NCT03323086|EG000|Reported Event|Brief Intervention (BI) With Technology Extender|"Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.~Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders"
11321952|NCT03323086|EG001|Reported Event|Brochure|"Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.~Brochure: Brochures provided one time"
11321953|NCT03323164|BG000|Baseline|Timolol|"Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.~Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation."
11321954|NCT03323164|BG001|Baseline|Brimonidine|"Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.~Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation."
11321955|NCT03323164|BG002|Baseline|Total|Total of all reporting groups
11321956|NCT03323164|FG000|Participant Flow|Timolol|"Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.~Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation."
11321957|NCT03323164|FG001|Participant Flow|Brimonidine|"Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.~Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation."
11321958|NCT03323164|OG000|Outcome|Brimonidine Group|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
11321959|NCT03323164|OG001|Outcome|Timolol Group|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
11321960|NCT03323164|OG000|Outcome|Control B|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Brimonidine eye drops to lower eye pressure before .
11321961|NCT03323164|OG001|Outcome|Brimonidine|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
11321962|NCT03323164|OG002|Outcome|Control T|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
11321963|NCT03323164|OG003|Outcome|Timolol|POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
11321964|NCT03323164|EG000|Reported Event|Timolol|"Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.~Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation."
11321965|NCT03323164|EG001|Reported Event|Brimonidine|"Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.~Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation."
11321966|NCT03323307|BG000|Baseline|OCT Imaging|All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
11321967|NCT03323307|FG000|Participant Flow|OCT Imaging|All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
11321968|NCT03323307|OG000|Outcome|OCT Imaging|All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
11321969|NCT03323307|EG000|Reported Event|OCT Imaging|All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
11321970|NCT03323723|BG000|Baseline|RS-2 SUI Device|"Comparing use of device to non-treatment phase~SUI Device: Pessary SUI device"
11321971|NCT03323723|FG000|Participant Flow|RS-2 SUI Device|All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
11321972|NCT03323723|OG000|Outcome|RS-2 SUI Device|All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
11321973|NCT03323723|OG000|Outcome|RS-2 SUI Device|"Comparing use of device to non-treatment phase~SUI Device: Pessary SUI device"
11321974|NCT03323723|EG000|Reported Event|RS-2 SUI Device|"Comparing use of device to non-treatment phase~SUI Device: Pessary SUI device"
11321975|NCT03323801|BG000|Baseline|13-cis Retinoic Acid|"20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11321976|NCT03323801|FG000|Participant Flow|13-cis Retinoic Acid|"20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11321977|NCT03323801|OG000|Outcome|Accutane-13-cis Retinoic Acid|"20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11321978|NCT03323801|OG000|Outcome|13-cis Retinoic Acid|"20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11321979|NCT03323801|EG000|Reported Event|Accutane-13-cis Retinoic Acid|"20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks~13-cis retinoic acid: Accutane is used for the treatment of severe acne"
11321980|NCT03323853|BG000|Baseline|CARS Report|CARS Report: Patients will be evaluated by emergency providers using the CARS report
11321981|NCT03323853|BG001|Baseline|No CARS Report|No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
11321982|NCT03323853|BG002|Baseline|Total|Total of all reporting groups
11321983|NCT03323853|FG000|Participant Flow|CARS Report|CARS Report: Patients will be evaluated by emergency providers using the CARS report
11321984|NCT03323853|FG001|Participant Flow|No CARS Report|No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
11321985|NCT03323853|OG000|Outcome|CARS Report|CARS Report: Patients will be evaluated by emergency providers using the CARS report
11321986|NCT03323853|OG001|Outcome|No CARS Report|No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
11321987|NCT03323853|EG000|Reported Event|CARS Report|CARS Report: Patients will be evaluated by emergency providers using the CARS report
11321988|NCT03323853|EG001|Reported Event|No CARS Report|No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
11321989|NCT03324451|BG000|Baseline|Intervention Arm|"The arm that receives TTM Intervention for Insulin Initiation. The intervention contains three parts: (1) individual intervention; (2) insulin injection follow-up management~TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change."
11321990|NCT03324451|BG001|Baseline|Control Arm|"The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.~Usual care: Regular patient education on insulin injection at the control arm hospital."
11321991|NCT03324451|BG002|Baseline|Total|Total of all reporting groups
11321992|NCT03324451|FG000|Participant Flow|Intervention Arm|"The arm that receives TTM Intervention for Insulin Initiation. The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management~TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change."
11321993|NCT03324451|FG001|Participant Flow|Control Arm|"The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.~Usual care: Regular patient education on insulin injection at the control arm hospital."
11321994|NCT03324451|OG000|Outcome|Intervention Arm|"The arm that receives TTM Intervention for Insulin Initiation. The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management~TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change."
11321995|NCT03324451|OG001|Outcome|Control Arm|"The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.~Usual care: Regular patient education on insulin injection at the control arm hospital."
11321996|NCT03324451|EG000|Reported Event|TTA Intervention|The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management.
11321997|NCT03324451|EG001|Reported Event|Control Arm|Participants in the control arm receives regular patient education.
11321998|NCT03324581|BG000|Baseline|OPC-64005|During the titration period, participants received OPC-64005 two 10 mg tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
11321999|NCT03324581|BG001|Baseline|Atomoxetine|"During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.~During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable."
11322000|NCT03324581|BG002|Baseline|Placebo|Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
11322001|NCT03324581|BG003|Baseline|Total|Total of all reporting groups
11322002|NCT03324581|FG000|Participant Flow|OPC-64005|During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
11322003|NCT03324581|FG001|Participant Flow|Atomoxetine|"During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.~During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable."
11322004|NCT03324581|FG002|Participant Flow|Placebo|Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
11322005|NCT03324581|OG000|Outcome|OPC-64005|During the titration period, participants received OPC-64005 two 10 mg tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
11322006|NCT03324581|OG001|Outcome|Atomoxetine|"During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.~During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable."
11322007|NCT03324581|OG002|Outcome|Placebo|Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
11322008|NCT03324581|EG000|Reported Event|OPC-64005|During the titration period, participants received OPC-64005 two 10 mg tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
11322009|NCT03324581|EG001|Reported Event|Atomoxetine|"During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.~During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable."
11322010|NCT03324581|EG002|Reported Event|Placebo|Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
11322011|NCT03324607|BG000|Baseline|Treatment|Twenty subjects completed the study. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit; thus, a total of 17 subjects (8M 9F) were included in the data analysis. Subjects were treated with Bevespi 2 puffs twice a day for 2 weeks.
11322012|NCT03324607|FG000|Participant Flow|Treatment|Twenty patients with a pulmonologist's diagnosis of either GOLD II or III COPD and no significant comorbidities were recruited. One patient was excluded from data analysis due to poor image signal-to-noise ratio, and two patients did not have both pre- and post-treatment ventilation images; thus, a total of 17 patients (8M; 9F) were included in the data analysis. The mean age was 64.3 ± 4.9.
11322013|NCT03324607|OG000|Outcome|Treatment|"glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up XeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.~hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.~Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi."
11322014|NCT03324607|OG000|Outcome|Single Arm|"glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study xeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.~hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.~Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi."
11322015|NCT03324607|OG000|Outcome|Treatment|"glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study xeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.~hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.~Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi."
11322016|NCT03324607|OG000|Outcome|Single Arm|"glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up XeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.~hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.~Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi."
11322017|NCT03324607|EG000|Reported Event|Treatment|"glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study xeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.~hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.~Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi."
11322018|NCT03325010|BG000|Baseline|Placebo|Participants received placebo (matching valbenazine) once daily for 12 weeks.
11322019|NCT03325010|BG001|Baseline|Valbenazine|Participants received valbenazine once daily for 12 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects <50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11322020|NCT03325010|BG002|Baseline|Total|Total of all reporting groups
11322021|NCT03325010|FG000|Participant Flow|Placebo|Participants received placebo (matching valbenazine) once daily for 12 weeks.
11322022|NCT03325010|FG001|Participant Flow|Valbenazine|Participants received valbenazine once daily for 12 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects <50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11322023|NCT03325010|OG000|Outcome|Placebo|Participants received placebo (matching valbenazine) once daily for 12 weeks.
11322024|NCT03325010|OG001|Outcome|Valbenazine|Participants received valbenazine once daily for 12 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects <50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11322025|NCT03325010|EG000|Reported Event|Placebo|Participants received placebo (matching valbenazine) once daily for 12 weeks.
11322026|NCT03325010|EG001|Reported Event|Valbenazine|Participants received valbenazine once daily for 12 weeks. The starting dose was 20 mg for participants <50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects <50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.
11322027|NCT03325556|BG000|Baseline|Pimavanserin Open-Label Period|Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.
11322028|NCT03325556|FG000|Participant Flow|Pimavanserin Open-Label Period|Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.
11322029|NCT03325556|FG001|Participant Flow|Pimavanserin Double-Blind Period|Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse
11322030|NCT03325556|FG002|Participant Flow|Placebo Double-Blind Period|Placebo once daily for 26 weeks or until relapse
11322031|NCT03325556|OG000|Outcome|Pimavanserin Double-Blind Period|Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse
11322032|NCT03325556|OG001|Outcome|Placebo Double-Blind Period|Placebo once daily for 26 weeks or until relapse
11322033|NCT03325556|EG000|Reported Event|Pimavanserin Open-Label Period|Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily
11322034|NCT03325556|EG001|Reported Event|Pimavanserin Double-Blind Period|Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse
11322035|NCT03325556|EG002|Reported Event|Placebo Double-Blind Period|Placebo once daily for 26 weeks or until relapse
11322036|NCT03325673|BG000|Baseline|TrueTear|TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
11322037|NCT03325673|BG001|Baseline|TrueTear Sham Control|TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
11322038|NCT03325673|BG002|Baseline|Total|Total of all reporting groups
11322039|NCT03325673|FG000|Participant Flow|TrueTear|TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
11322040|NCT03325673|FG001|Participant Flow|TrueTear Sham Control|TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
11322041|NCT03325673|OG000|Outcome|TrueTear|TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
10827870|NCT00112242|BG004|Baseline|Native and Analog Peptide Combination Vaccination + CpG + IL-2|"Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2~Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2"
10827871|NCT00112242|BG005|Baseline|Total|Total of all reporting groups
11322042|NCT03325673|OG001|Outcome|TrueTear Sham Control|TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
11322043|NCT03325673|EG000|Reported Event|TrueTear|TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
11322044|NCT03325673|EG001|Reported Event|TrueTear Sham Control|TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
11322045|NCT03325816|BG000|Baseline|Phase I - Dose Level -1|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322046|NCT03325816|BG001|Baseline|Phase I - Dose Level 0|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322047|NCT03325816|BG002|Baseline|Total|Total of all reporting groups
11322048|NCT03325816|FG000|Participant Flow|Phase I - Dose Level -1|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322049|NCT03325816|FG001|Participant Flow|Phase I - Dose Level 0|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322050|NCT03325816|OG000|Outcome|Phase I|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 or 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322051|NCT03325816|OG000|Outcome|Phase II|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322052|NCT03325816|OG000|Outcome|Phase I - Dose Level -1|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322053|NCT03325816|OG001|Outcome|Phase I - Dose Level 0|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322054|NCT03325816|EG000|Reported Event|Phase I - Dose Level -1|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322055|NCT03325816|EG001|Reported Event|Phase I - Dose Level 0|Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate.
11322056|NCT03325881|BG000|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11322057|NCT03325881|BG001|Baseline|SHP465|Participants received 6.25 mg SHP465 capsule orally once daily for 4 weeks.
11322058|NCT03325881|BG002|Baseline|Total|Total of all reporting groups
11322059|NCT03325881|FG000|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11322060|NCT03325881|FG001|Participant Flow|SHP465|Participants received 6.25 milligrams (mg) SHP465 capsule orally once daily for 4 weeks.
11322061|NCT03325881|OG000|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11322062|NCT03325881|OG001|Outcome|SHP465|Participants received 6.25 mg SHP465 capsule orally once daily for 4 weeks.
11322063|NCT03325881|OG000|Outcome|Placebo|Participant received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11322064|NCT03325881|OG001|Outcome|SHP465|Participants received 6.25 milligrams (mg) SHP465 capsule orally once daily for 4 weeks.
11322065|NCT03325881|EG000|Reported Event|Placebo|Participant received placebo matched to SHP465 capsule orally once daily for 4 weeks.
11322066|NCT03325881|EG001|Reported Event|SHP465|Participants received 6.25 milligram (mg) of SHP465 capsule orally once daily for 4 weeks.
10827872|NCT00112242|FG000|Participant Flow|1. Melan-A ELA|500 mcg Melan-A ELA analog peptide + 1 ml Montanide
11322067|NCT03325894|BG000|Baseline|Group A (Antecedent Studies)|Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322068|NCT03325894|BG001|Baseline|Group B (Direct Enrollment)|Participants who directly enrolled in this study were in group B and received 6.25 mg SHP465 capsule orally once daily for up to 330 days.
11322069|NCT03325894|BG002|Baseline|Total|Total of all reporting groups
11322070|NCT03325894|FG000|Participant Flow|Group A (Antecedent Studies)|Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322071|NCT03325894|FG001|Participant Flow|Group B (Direct Enrollment)|Participants who directly enrolled in this study were in group B and received 6.25 mg SHP465 capsule orally once daily for up to 330 days.
11322072|NCT03325894|OG000|Outcome|Group A (Antecedent Studies)|Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322073|NCT03325894|OG001|Outcome|Group B (Direct Enrollment)|Participants who directly enrolled in this study were in group B and received 6.25 mg SHP465 capsule orally once daily for up to 330 days.
11322074|NCT03325894|OG000|Outcome|Group A (Antecedent Studies)|Participants in group A received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322075|NCT03325894|OG001|Outcome|Group B (Direct Enrollment)|Participants in group B received 6.25 mg SHP465 capsule orally once daily for up to 330 days.
10827873|NCT00112242|FG001|Participant Flow|2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
11322076|NCT03325894|OG000|Outcome|Group A (Antecedent Study)|Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322077|NCT03325894|EG000|Reported Event|Group A (Antecedent Studies)|Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days.
11322078|NCT03325894|EG001|Reported Event|Group B (Direct Enrollment)|Participants who directly enrolled in this study were in group B and received 6.25 mg SHP465 capsule orally once daily for up to 330 days.
11322079|NCT03326323|BG000|Baseline|Patients Undergoing ANH During CABG|"Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.~Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery."
10827874|NCT00112242|FG002|Participant Flow|3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
11322080|NCT03326323|FG000|Participant Flow|Patients Undergoing ANH During CABG|"Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.~Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery."
11322081|NCT03326323|OG000|Outcome|Patients Undergoing ANH During CABG|"Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.~Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery."
11322082|NCT03326323|EG000|Reported Event|Patients Undergoing ANH During CABG|"Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.~Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery."
11322083|NCT03326518|BG000|Baseline|Lumentin® 44|"Contrast agent~Lumentin® 44: Contrast agent"
11322084|NCT03326518|BG001|Baseline|Diluted Omnipaque®|"Contrast agent~Diluted Omnipaque®: Contrast agent"
11322085|NCT03326518|BG002|Baseline|Movprep®|"Contrast agent~Movprep®: Contrast agent"
11322086|NCT03326518|BG003|Baseline|Total|Total of all reporting groups
11322087|NCT03326518|FG000|Participant Flow|Lumentin® 44|"Contrast agent~Lumentin® 44: Contrast agent"
11322088|NCT03326518|FG001|Participant Flow|Diluted Omnipaque®|"Contrast agent~Diluted Omnipaque®: Contrast agent"
11322089|NCT03326518|FG002|Participant Flow|Movprep®|"Contrast agent~Movprep®: Contrast agent"
11322090|NCT03326518|OG000|Outcome|Lumentin® 44|"Contrast agent~Lumentin® 44: Contrast agent"
11322091|NCT03326518|OG001|Outcome|Diluted Omnipaque®|"Contrast agent~Diluted Omnipaque®: Contrast agent"
11322092|NCT03326518|OG002|Outcome|Movprep®|"Contrast agent~Movprep®: Contrast agent"
11322093|NCT03326518|EG000|Reported Event|Lumentin® 44|"Contrast agent~Lumentin® 44: Contrast agent"
11322094|NCT03326518|EG001|Reported Event|Diluted Omnipaque®|"Contrast agent~Diluted Omnipaque®: Contrast agent"
11322095|NCT03326518|EG002|Reported Event|Movprep®|"Contrast agent~Movprep®: Contrast agent"
10843008|NCT00251316|OG001|Outcome|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
11322096|NCT03326843|BG000|Baseline|Avatrombopag 60 mg|"Open-label: oral avatrombopag~Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure."
11322097|NCT03326843|FG000|Participant Flow|Avatrombopag 60 mg|"Open-label: oral avatrombopag~Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure."
11322098|NCT03326843|OG000|Outcome|Avatrombopag 60 mg|"Open-label: oral avatrombopag~Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure."
11322099|NCT03326843|EG000|Reported Event|Avatrombopag 60 mg|"Open-label: oral avatrombopag~Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure."
11322100|NCT03326895|BG000|Baseline|ECHELON CIRCULAR Powered Stapler|Use of the ECHELON CIRCULAR Powered Stapler
11322101|NCT03326895|FG000|Participant Flow|ECHELON CIRCULAR Powered Stapler|Use of the ECHELON CIRCULAR Powered Stapler
11322102|NCT03326895|OG000|Outcome|ECHELON CIRCULAR Powered Stapler|Use of the ECHELON CIRCULAR Powered Stapler
11322103|NCT03326895|EG000|Reported Event|ECHELON CIRCULAR Powered Stapler|Use of the ECHELON CIRCULAR Powered Stapler
11322104|NCT03326986|BG000|Baseline|Panel A|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-7252 (1 mg, 6 mg, 24 mg, 72 mg, or 108 mg) and 2 participants received placebo in a fasted state. Dosing periods alternated with Panel B.
11322105|NCT03326986|BG001|Baseline|Panel B|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-7252 (3 mg, 12 mg, 48 mg, 72 mg, or 162 mg) and 2 participants received placebo in a fasted state. Dosing periods alternated with Panel A.
11322106|NCT03326986|BG002|Baseline|Panel C|Within each of 3 single dose treatment periods, 6 participants received a single dose of MK-7252 (120 mg or 180 mg) and 2 participants received placebo in a fasted state. The 120 mg dose of MK-7252 was administered in the first 2 periods and the 180 mg dose was administered in the third period.
11322107|NCT03326986|BG003|Baseline|Total|Total of all reporting groups
11322108|NCT03326986|FG000|Participant Flow|Panel A|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-7252 (1 mg, 6 mg, 24 mg, 72 mg, or 108 mg) and 2 participants received placebo in a fasted state. Dosing periods alternated with Panel B.
11322109|NCT03326986|FG001|Participant Flow|Panel B|Within each of the 5 rising dose treatment periods, 6 participants received a single dose of MK-7252 (3 mg, 12 mg, 48 mg, 72 mg, or 162 mg) and 2 participants received placebo in a fasted state. Dosing periods alternated with Panel A.
11322110|NCT03326986|FG002|Participant Flow|Panel C|Within each of 3 single dose treatment periods, 6 participants received a single dose of MK-7252 (120 mg or 180 mg) and 2 participants received placebo in a fasted state. The 120 mg dose of MK-7252 was administered in the first 2 periods and the 180 mg dose was administered in the third period.
11322111|NCT03326986|OG000|Outcome|MK-7252 1 mg|Single oral dose of 1 mg MK-7252 administered in a fasted state
11322112|NCT03326986|OG001|Outcome|MK-7252 3 mg|Single oral dose of 3 mg MK-7252 administered in a fasted state
11322113|NCT03326986|OG002|Outcome|MK-7252 6 mg|Single oral dose of 6 mg MK-7252 administered in a fasted state
11322114|NCT03326986|OG003|Outcome|MK-7252 12 mg|Single oral dose of 12 mg MK-7252 administered in a fasted state
11322115|NCT03326986|OG004|Outcome|MK-7252 24 mg|Single oral dose of 24 mg MK-7252 administered in a fasted state
11322116|NCT03326986|OG005|Outcome|MK-7252 48 mg|Single oral dose of 48 mg MK-7252 administered in a fasted state
11322117|NCT03326986|OG006|Outcome|MK-7252 72 mg|Single oral dose of 72 mg MK-7252 administered in a fasted state
11322118|NCT03326986|OG007|Outcome|MK-7252 108 mg|Single oral dose of 108 mg MK-7252 administered in a fasted state
11322119|NCT03326986|OG008|Outcome|MK-7252 120 mg|Single oral dose of 120 mg MK-7252 administered in a fasted state
11322120|NCT03326986|OG009|Outcome|MK-7252 162 mg|Single oral dose of 162 mg MK-7252 administered in a fasted state
11322121|NCT03326986|OG010|Outcome|MK-7252 180 mg|Single oral dose of 180 mg MK-7252 administered in a fasted state
11322122|NCT03326986|OG011|Outcome|Placebo|Single oral dose of placebo to match MK-7252 administered in a fasted state
11322123|NCT03326986|OG000|Outcome|Panel A MK-7252 1 mg|Single oral dose of 1 mg MK-7252 administered in a fasted state
11322124|NCT03326986|OG001|Outcome|Panel B MK-7252 3 mg|Single oral dose of 3 mg MK-7252 administered in a fasted state
11322125|NCT03326986|OG002|Outcome|Panel A MK-7252 6 mg|Single oral dose of 6 mg MK-7252 administered in a fasted state
11322126|NCT03326986|OG003|Outcome|Panel B MK-7252 12 mg|Single oral dose of 12 mg MK-7252 administered in a fasted state
11322127|NCT03326986|OG004|Outcome|Panel A MK-7252 24 mg|Single oral dose of 24 mg MK-7252 administered in a fasted state
11322128|NCT03326986|OG005|Outcome|Panel B MK-7252 48 mg|Single oral dose of 48 mg MK-7252 administered in a fasted state
11322129|NCT03326986|OG006|Outcome|Panel A MK-7252 72 mg|Single oral dose of 72 mg MK-7252 administered in Panel A in a fasted state
11322130|NCT03326986|OG007|Outcome|Panel B MK-7252 72 mg|Single oral dose of 72 mg MK-7252 administered Panel B in a fasted state
11322131|NCT03326986|OG008|Outcome|Panel A MK-7252 108 mg|Single oral dose of 108 mg MK-7252 administered in a fasted state
11322132|NCT03326986|OG009|Outcome|Panel B MK-7252 162 mg|Single oral dose of 162 mg MK-7252 administered in a fasted state
11322133|NCT03326986|OG010|Outcome|Panel C MK-7252 120 mg Period 1|Single oral dose of 120 mg MK-7252 administered in Panel C Period 1 in a fasted state
11322134|NCT03326986|OG011|Outcome|Panel C MK-7252 120 mg Period 2|Single oral dose of 120 mg MK-7252 administered in Panel C Period 2 in a fasted state
11322135|NCT03326986|OG012|Outcome|Panel C MK-7252 180 mg Period 3|Single oral dose of 180 mg MK-7252 administered in Panel C Period 3 in a fasted state
11322136|NCT03326986|OG013|Outcome|Placebo|Single oral dose of placebo to match MK-7252 administered in a fasted state
11322137|NCT03326986|EG000|Reported Event|MK-7252 1 mg|Single oral dose of 1 mg MK-7252 administered in a fasted state
11322138|NCT03326986|EG001|Reported Event|MK-7252 3 mg|Single oral dose of 3 mg MK-7252 administered in a fasted state
11322139|NCT03326986|EG002|Reported Event|MK-7252 6 mg|Single oral dose of 6 mg MK-7252 administered in a fasted state
11322140|NCT03326986|EG003|Reported Event|MK-7252 12 mg|Single oral dose of 12 mg MK-7252 administered in a fasted state
11322141|NCT03326986|EG004|Reported Event|MK-7252 24 mg|Single oral dose of 24 mg MK-7252 administered in a fasted state
11322142|NCT03326986|EG005|Reported Event|MK-7252 48 mg|Single oral dose of 48 mg MK-7252 administered in a fasted state
11322143|NCT03326986|EG006|Reported Event|MK-7252 72 mg|Single oral dose of 72 mg of MK-7252 administered in a fasted state
11322144|NCT03326986|EG007|Reported Event|MK-7252 108 mg|Single oral dose of 108 mg MK-7252 administered in a fasted state
11322145|NCT03326986|EG008|Reported Event|MK-7252 120 mg|Single oral dose of 120 mg of MK-7252 administered in a fasted state
11322146|NCT03326986|EG009|Reported Event|MK-7252 162 mg|Single oral dose of 162 mg MK-7252 administered in a fasted state
11322147|NCT03326986|EG010|Reported Event|MK-7252 180 mg|Single oral dose of 180 mg of MK-7252 administered in a fasted state
11322148|NCT03326986|EG011|Reported Event|Placebo|Single oral dose of placebo to match MK-7252 administered in a fasted state
11322149|NCT03326986|EG012|Reported Event|Post-Study|MK-7252 or placebo as a single dose in the post-study period administered in a fasted state
11322150|NCT03326999|BG000|Baseline|Bupivacaine Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
11322151|NCT03326999|BG001|Baseline|Saline Control Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
11322152|NCT03326999|BG002|Baseline|Total|Total of all reporting groups
11322153|NCT03326999|FG000|Participant Flow|Investigational Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
11322154|NCT03326999|FG001|Participant Flow|Control Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
11322155|NCT03326999|OG000|Outcome|Bupivacaine Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
11322156|NCT03326999|OG001|Outcome|Saline Control Arm|Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
11322157|NCT03326999|EG000|Reported Event|Investigational Arm|Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
11322158|NCT03326999|EG001|Reported Event|Control Arm|Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
11322159|NCT03327051|BG000|Baseline|Omeprazole and VSL #3|Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
11322160|NCT03327051|BG001|Baseline|Placebo and VSL #3|Placebo and VSL #3 Probiotics
11322161|NCT03327051|BG002|Baseline|Total|Total of all reporting groups
11322162|NCT03327051|FG000|Participant Flow|Omeprazole and VSL #3|Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
11322163|NCT03327051|FG001|Participant Flow|Placebo and VSL #3|Placebo and VSL #3 Probiotics
11322164|NCT03327051|OG000|Outcome|Omeprazole and VSL #3|Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
11322165|NCT03327051|OG001|Outcome|Placebo and VSL #3|Placebo and VSL #3 Probiotics
11322166|NCT03327051|OG000|Outcome|Placebo and VSL #3|Placebo and VSL #3 Probiotics
11322167|NCT03327051|EG000|Reported Event|Omeprazole and VSL #3|Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
11322168|NCT03327051|EG001|Reported Event|Placebo and VSL #3|Placebo and VSL #3 Probiotics
11322169|NCT03327220|BG000|Baseline|Iovera° Device Treatment Group|Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to TKA. Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322170|NCT03327220|BG001|Baseline|Standard of Care Treatment Group|All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322171|NCT03327220|BG002|Baseline|Total|Total of all reporting groups
11322172|NCT03327220|FG000|Participant Flow|Iovera° Device Treatment Group|Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to total knee arthroplasty (TKA). Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322173|NCT03327220|FG001|Participant Flow|Standard of Care Treatment Group|All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322174|NCT03327220|OG000|Outcome|Iovera° Device Treatment Group|Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to TKA. Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322175|NCT03327220|OG001|Outcome|Standard of Care Treatment Group|All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322176|NCT03327220|EG000|Reported Event|Iovera° Device Treatment Group|Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to TKA. Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322177|NCT03327220|EG001|Reported Event|Standard of Care Treatment Group|All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.
11322178|NCT03327402|BG000|Baseline|SHP465|Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks.
11322179|NCT03327402|FG000|Participant Flow|SHP465|Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks.
11322180|NCT03327402|OG000|Outcome|SHP465|Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks.
11322181|NCT03327402|EG000|Reported Event|SHP465|Participants aged 4-5 years received SHP465 capsule at a dose of 6.25 milligram (mg) orally once daily for 4 weeks.
11322182|NCT03327571|BG000|Baseline|Group 1: cHL|Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322183|NCT03327571|BG001|Baseline|Group 2: RRHL|Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322184|NCT03327571|BG002|Baseline|Total|Total of all reporting groups
11322185|NCT03327571|FG000|Participant Flow|Group 1: cHL|Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322186|NCT03327571|FG001|Participant Flow|Group 2: RRHL|Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322187|NCT03327571|OG000|Outcome|Group 2: RRHL|Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322188|NCT03327571|OG000|Outcome|Group 1: cHL|Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322189|NCT03327571|OG001|Outcome|Group 2: RRHL|Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322190|NCT03327571|EG000|Reported Event|Group 1: cHL|Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322191|NCT03327571|EG001|Reported Event|Group 2: RRHL|Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first.
11322192|NCT03328182|BG000|Baseline|New Oral Endotracheal Tube Holder|"Single Study Product Arm~New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube."
11322193|NCT03328182|FG000|Participant Flow|New Oral Endotracheal Tube Holder|"Single Study Product Arm~New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube."
11322194|NCT03328182|OG000|Outcome|New Oral Endotracheal Tube Holder|"Single Study Product Arm~New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube."
11322195|NCT03328182|EG000|Reported Event|New Oral Endotracheal Tube Holder|"Single Study Product Arm~New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube."
11322196|NCT03328208|BG000|Baseline|Comfort Talk® App Group|"Patients will receive a tablet preloaded with the Comfort Talk® app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment. Upon departure, they will receive a download coupon for the app for home use.~Comfort Talk® app: Test app"
11322197|NCT03328208|BG001|Baseline|White Noise Group|"Patients will receive a tablet preloaded with a white noise app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment.~White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app"
11322198|NCT03328208|BG002|Baseline|Total|Total of all reporting groups
11322199|NCT03328208|FG000|Participant Flow|Comfort Talk® App Group|"Patients will receive a tablet preloaded with the Comfort Talk® app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment. Upon departure, they will receive a download coupon for the app for home use.~Comfort Talk® app: Test app"
11322200|NCT03328208|FG001|Participant Flow|White Noise Group|"Patients will receive a tablet preloaded with a white noise app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment.~White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app"
11322201|NCT03328208|OG000|Outcome|Comfort Talk® App Group|"Patients will receive a tablet preloaded with the Comfort Talk® app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment. Upon departure, they will receive a download coupon for the app for home use.~Comfort Talk® app: Test app"
11322202|NCT03328208|OG001|Outcome|White Noise Group|"Patients will receive a tablet preloaded with a white noise app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment.~White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app"
11322203|NCT03328208|EG000|Reported Event|Comfort Talk® App Group|"Patients will receive a tablet preloaded with the Comfort Talk® app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment. Upon departure, they will receive a download coupon for the app for home use.~Comfort Talk® app: Test app"
11322204|NCT03328208|EG001|Reported Event|White Noise Group|"Patients will receive a tablet preloaded with a white noise app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment.~White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app"
11322205|NCT03328325|BG000|Baseline|Arm 1|"0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013."
11322206|NCT03328325|FG000|Participant Flow|Arm 1|"0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013."
11322207|NCT03328325|OG000|Outcome|Arm 1|"0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013."
11322208|NCT03328325|EG000|Reported Event|Arm 1|"0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.~Influenza Virus Quadrivalent Inactivated Vaccine: A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013."
11322209|NCT03328624|BG000|Baseline|DVT Cuff Users|"Current or previous DVT cuff users~Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff"
11322210|NCT03328624|FG000|Participant Flow|DVT Cuff Users|"Current or previous DVT cuff users~Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff"
11322211|NCT03328624|OG000|Outcome|DVT Cuff Users|"Current or previous DVT cuff users~Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff"
11322212|NCT03328624|EG000|Reported Event|DVT Cuff Users|"Current or previous DVT cuff users~Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff"
11333461|NCT03515681|EG000|Reported Event|Intervention|"Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.~Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment."
11322213|NCT03328832|BG000|Baseline|Combined Topical TXA and Floseal|"Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322214|NCT03328832|BG001|Baseline|Topical TXA Alone|"Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322215|NCT03328832|BG002|Baseline|Total|Total of all reporting groups
11322216|NCT03328832|FG000|Participant Flow|Combined Topical TXA and Floseal|"Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322217|NCT03328832|FG001|Participant Flow|Topical TXA Alone|"Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322218|NCT03328832|OG000|Outcome|Combined Topical TXA and Floseal|"Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322219|NCT03328832|OG001|Outcome|Topical TXA Alone|"Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322220|NCT03328832|EG000|Reported Event|Combined Topical TXA and Floseal|"Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322221|NCT03328832|EG001|Reported Event|Topical TXA Alone|"Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.~Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule~rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14."
11322222|NCT03328897|BG000|Baseline|Omalizumab 300mg|patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322223|NCT03328897|BG001|Baseline|Omalizumab 150mg|patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
11322224|NCT03328897|BG002|Baseline|Placebo|patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322225|NCT03328897|BG003|Baseline|Total|Total of all reporting groups
11322226|NCT03328897|FG000|Participant Flow|Omalizumab 300mg|patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322227|NCT03328897|FG001|Participant Flow|Omalizumab 150mg|patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
11322228|NCT03328897|FG002|Participant Flow|Placebo|patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322229|NCT03328897|OG000|Outcome|Omalizumab 300mg|patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322230|NCT03328897|OG001|Outcome|Omalizumab 150mg|patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
11322231|NCT03328897|OG002|Outcome|Placebo|patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322232|NCT03328897|EG000|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
11322233|NCT03328897|EG001|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
11322234|NCT03328897|EG002|Reported Event|Placebo|patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
11322235|NCT03328949|BG000|Baseline|Coronary Intravascular Lithotripsy (IVL) System|"All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement.~Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy)."
11322236|NCT03328949|FG000|Participant Flow|Coronary Intravascular Lithotripsy (IVL) System|"All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement.~Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy)."
11322237|NCT03328949|OG000|Outcome|Coronary Intravascular Lithotripsy (IVL) System|"All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement.~Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy)."
11322238|NCT03328949|OG000|Outcome|Coronary Intravascular Lithotripsy (IVL) System|"All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.~Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy)."
11322239|NCT03328949|EG000|Reported Event|Coronary Intravascular Lithotripsy (IVL) System|"All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.~Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy)."
11322240|NCT03329196|BG000|Baseline|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11322241|NCT03329196|BG001|Baseline|Darbepoetin Alfa|Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
11322242|NCT03329196|BG002|Baseline|Total|Total of all reporting groups
11322243|NCT03329196|FG000|Participant Flow|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11322244|NCT03329196|FG001|Participant Flow|Darbepoetin Alfa|Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
11322245|NCT03329196|OG000|Outcome|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11322246|NCT03329196|OG001|Outcome|Darbepoetin Alfa|Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
11322247|NCT03329196|EG000|Reported Event|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11322248|NCT03329196|EG001|Reported Event|Darbepoetin Alfa|Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
11322249|NCT03329209|BG000|Baseline|Vedolizumab 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
11322250|NCT03329209|FG000|Participant Flow|Vedolizumab 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
11322251|NCT03329209|OG000|Outcome|Vedolizumab 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
11322252|NCT03329209|EG000|Reported Event|Vedolizumab 300 mg|Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
11322253|NCT03329352|BG000|Baseline|F&P Toffee Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Toffee Full-Face Mask: The F&P Toffee Full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3."
11322254|NCT03329352|FG000|Participant Flow|F&P Toffee Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Toffee Full-Face Mask: The F&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3)."
11333462|NCT03515681|EG001|Reported Event|Control|Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).
11322255|NCT03329352|OG000|Outcome|F&P Toffee Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Toffee Full-Face Mask: The F&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3."
11322256|NCT03329352|OG000|Outcome|F&P Toffee Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Toffee Full-Face Mask: The F&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3)."
11322257|NCT03329352|OG000|Outcome|F&P Toffee Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Toffee Full-Face Mask: The F&P Toffee Full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3."
11322258|NCT03329352|EG000|Reported Event|F&P Full-Face Mask|"Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.~F&P Full-Face Mask: The F&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.~Adverse event data will be collated for both arms of the trial for simplicity."
11322259|NCT03329573|BG000|Baseline|Paroxetine 40 mg, GSKT Followed by Mississauga- Fed|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
11322260|NCT03329573|BG001|Baseline|Paroxetine 40 mg, Mississauga Followed by GSKT- Fed|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
11322261|NCT03329573|BG002|Baseline|Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
11322262|NCT03329573|BG003|Baseline|Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
11322263|NCT03329573|BG004|Baseline|Total|Total of all reporting groups
11322264|NCT03329573|FG000|Participant Flow|Paroxetine 40 mg, GSKT Followed by Mississauga- Fed|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
11322265|NCT03329573|FG001|Participant Flow|Paroxetine 40 mg, Mississauga Followed by GSKT- Fed|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.
11322266|NCT03329573|FG002|Participant Flow|Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
11322267|NCT03329573|FG003|Participant Flow|Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.
11322268|NCT03329573|OG000|Outcome|Paroxetine 40 mg, GSKT- Fed|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
11322269|NCT03329573|OG001|Outcome|Paroxetine 40 mg, Mississauga- Fed|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
11322270|NCT03329573|OG000|Outcome|Paroxetine 40 mg, GSKT- Fasted|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
11322271|NCT03329573|OG001|Outcome|Paroxetine 40 mg, Mississauga- Fasted|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
11322272|NCT03329573|EG000|Reported Event|Paroxetine 40 mg, GSKT- Fed|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
11322273|NCT03329573|EG001|Reported Event|Paroxetine 40 mg, Mississauga- Fed|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fed condition.
11322274|NCT03329573|EG002|Reported Event|Paroxetine 40 mg, GSKT- Fasted|Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
11322275|NCT03329573|EG003|Reported Event|Paroxetine 40 mg, Mississauga- Fasted|Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg*2 tablets) administered orally on Day 1 in either treatment period 1 or 2 as per randomization under fasting condition.
11322276|NCT03329846|BG000|Baseline|Nivolumab + BMS-986205|Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
11322277|NCT03329846|BG001|Baseline|Nivolumab|Nivolumab 480 mg IV Q4W
11322278|NCT03329846|BG002|Baseline|Total|Total of all reporting groups
11322279|NCT03329846|FG000|Participant Flow|Nivolumab + BMS-986205|Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
11322280|NCT03329846|FG001|Participant Flow|Nivolumab|Nivolumab 480 mg IV Q4W
11322281|NCT03329846|OG000|Outcome|Nivolumab + BMS-986205|Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
11322282|NCT03329846|OG001|Outcome|Nivolumab|Nivolumab 480 mg IV Q4W
11322283|NCT03329846|EG000|Reported Event|Nivolumab + BMS-986205|Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
11322284|NCT03329846|EG001|Reported Event|Nivolumab|Nivolumab 480 mg IV Q4W
11322285|NCT03329885|BG000|Baseline|Part A: Placebo|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322286|NCT03329885|BG001|Baseline|Part A: BMS-986251 2 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322287|NCT03329885|BG002|Baseline|Part A: BMS-986251 6 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322288|NCT03329885|BG003|Baseline|Part A: BMS-986251 15 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322289|NCT03329885|BG004|Baseline|Part A: BMS-986251 30 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322290|NCT03329885|BG005|Baseline|Part A : BMS-986251 60 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322291|NCT03329885|BG006|Baseline|Total|Total of all reporting groups
11322292|NCT03329885|FG000|Participant Flow|Part A: Placebo|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322293|NCT03329885|FG001|Participant Flow|Part A: BMS-986251 2 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322294|NCT03329885|FG002|Participant Flow|Part A: BMS-986251 6 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322295|NCT03329885|FG003|Participant Flow|Part A: BMS-986251 15 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322296|NCT03329885|FG004|Participant Flow|Part A: BMS-986251 30 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322297|NCT03329885|FG005|Participant Flow|Part A : BMS-986251 60 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322298|NCT03329885|FG006|Participant Flow|Part B: Placebo|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322299|NCT03329885|FG007|Participant Flow|Part B: 3 mg QD (Once Daily)|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322300|NCT03329885|FG008|Participant Flow|Part C: Multiple Dosing in Psoriasis Patients|Psoriasis patients to receive daily escalating oral doses of BMS-986251 or placebo
11322301|NCT03329885|OG000|Outcome|Part A: Placebo|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322302|NCT03329885|OG001|Outcome|Part A: BMS-986251 2 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322303|NCT03329885|OG002|Outcome|Part A: BMS-986251 6 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322304|NCT03329885|OG003|Outcome|Part A: BMS-986251 15 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322305|NCT03329885|OG004|Outcome|Part A: BMS-986251 30 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322306|NCT03329885|OG005|Outcome|Part A : BMS-986251 60 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322307|NCT03329885|OG006|Outcome|Part B: Placebo|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322308|NCT03329885|OG007|Outcome|Part B: 3 mg QD (Once Daily)|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322309|NCT03329885|OG000|Outcome|Part B: Placebo|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322310|NCT03329885|OG001|Outcome|Part B: 3 mg QD (Once Daily)|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322311|NCT03329885|EG000|Reported Event|Part A: Placebo|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322312|NCT03329885|EG001|Reported Event|Part A: BMS-986251 2 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322313|NCT03329885|EG002|Reported Event|Part A: BMS-986251 6 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322314|NCT03329885|EG003|Reported Event|Part A: BMS-986251 15 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322315|NCT03329885|EG004|Reported Event|Part A: BMS-986251 30 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322316|NCT03329885|EG005|Reported Event|Part A : BMS-986251 60 mg|Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
11322317|NCT03329885|EG006|Reported Event|Part B: Placebo|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322318|NCT03329885|EG007|Reported Event|Part B: 3 mg QD (Once Daily)|Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
11322319|NCT03329911|BG000|Baseline|EU Avastin®|"Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~EU Avastin®: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322320|NCT03329911|BG001|Baseline|BAT1706|"BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~BAT1706: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322321|NCT03329911|BG002|Baseline|Total|Total of all reporting groups
11322322|NCT03329911|FG000|Participant Flow|EU Avastin®|"Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~EU Avastin®: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322323|NCT03329911|FG001|Participant Flow|BAT1706|"BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~BAT1706: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322324|NCT03329911|OG000|Outcome|EU Avastin®|"Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~EU Avastin®: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322325|NCT03329911|OG001|Outcome|BAT1706|"BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~BAT1706: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322326|NCT03329911|EG000|Reported Event|EU Avastin®|"Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~EU Avastin®: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322327|NCT03329911|EG001|Reported Event|BAT1706|"BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.~Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles~Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles~BAT1706: 100 mg/4 mL~Paclitaxel: 200 mg/m²~carboplatin: target area under the curve [AUC] 6 mg/mL•minute"
11322328|NCT03329937|BG000|Baseline|Niraparib 200 mg|Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed.
11322329|NCT03329937|FG000|Participant Flow|Niraparib 200 mg|Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed.
11333463|NCT03515824|BG000|Baseline|Part A: MK-1697 20 mg|Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11322330|NCT03329937|OG000|Outcome|Niraparib 200 mg|Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed.
11322331|NCT03329937|EG000|Reported Event|Niraparib 200 mg|Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed.
11322332|NCT03329989|BG000|Baseline|Collagenase Clostridium Histolyticum (CCH)|12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
11322333|NCT03329989|FG000|Participant Flow|Collagenase Clostridium Histolyticum (CCH)|12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
11322334|NCT03329989|OG000|Outcome|Collagenase Clostridium Histolyticum (CCH)|12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
11322335|NCT03329989|EG000|Reported Event|Collagenase Clostridium Histolyticum (CCH)|"EN3835 0.84mg (Collagenase Clostridium Histolyticum)~Collagenase Clostridium Histolyticum: During 3 treatment visits 12 injections is given per treatment area"
11322336|NCT03330002|BG000|Baseline|MANTA Vascular Closure Device (VCD)|MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
11322337|NCT03330002|FG000|Participant Flow|MANTA Vascular Closure Device (VCD)|MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
11322338|NCT03330002|OG000|Outcome|MANTA Vascular Closure Device (VCD)|MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
11322339|NCT03330002|EG000|Reported Event|MANTA Vascular Closure Device (VCD)|MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
11322340|NCT03330041|BG000|Baseline|Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart|"Wound closed with sutures spaced 2 and 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern~Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material"
11322341|NCT03330041|FG000|Participant Flow|All Participants|A split wound model was used, where half of the wound was repaired with sutures placed 2 millimeters apart and the other half is repaired with sutures placed 5 millimeters apart. A predetermined, concealed randomization number was obtained from the RedCap randomization module, which specified how Side A was treated. Side B was treated the opposite way as A.
11322342|NCT03330041|OG000|Outcome|Fast Absorbing Gut Suture Placed 2 mm Apart|"Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern.~Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material."
11322343|NCT03330041|OG001|Outcome|Fast Absorbing Gut Suture Placed 5 mm Apart|"Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern.~Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material."
11322344|NCT03330041|EG000|Reported Event|Fast Absorbing Gut Suture Placed 2 mm Apart|"Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern~Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material"
11322345|NCT03330041|EG001|Reported Event|Fast Absorbing Gut Suture Placed 5 mm Apart|"Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern~Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material"
11322346|NCT03330119|BG000|Baseline|Alternate Management|Alternate Management: With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
11322347|NCT03330119|BG001|Baseline|Control|"The regular Lankenau cesarean section order set.~Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request."
11322348|NCT03330119|BG002|Baseline|Total|Total of all reporting groups
11333464|NCT03515824|BG001|Baseline|Part A: MK-1697 65 mg|Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333465|NCT03515824|BG002|Baseline|Part A: MK-1697 200 mg|Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333466|NCT03515824|BG003|Baseline|Total|Total of all reporting groups
11333467|NCT03515824|FG000|Participant Flow|Part A: MK-1697 20 mg|Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11322349|NCT03330119|FG000|Participant Flow|Alternate Management|Alternate Management: With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
11322350|NCT03330119|FG001|Participant Flow|Control|"The regular Lankenau cesarean section order set.~Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request."
11322351|NCT03330119|OG000|Outcome|Alternate Management|Alternate Management: With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
11322352|NCT03330119|OG001|Outcome|Control|"The regular Lankenau cesarean section order set.~Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request."
11322353|NCT03330119|EG000|Reported Event|Alternate Management|Alternate Management: With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
11322354|NCT03330119|EG001|Reported Event|Control|"The regular Lankenau cesarean section order set.~Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request."
11322355|NCT03330236|BG000|Baseline|EEG Guided|"All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.~Anesthetic depth management: The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring."
11322356|NCT03330236|BG001|Baseline|Usual Care|All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
11322357|NCT03330236|BG002|Baseline|Total|Total of all reporting groups
11322358|NCT03330236|FG000|Participant Flow|EEG Guided|"All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.~Anesthetic depth management: The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring."
11322359|NCT03330236|FG001|Participant Flow|Usual Care|All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
11333468|NCT03515824|FG001|Participant Flow|Part A: MK-1697 65 mg|Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333469|NCT03515824|FG002|Participant Flow|Part A: MK-1697 200 mg|Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11322360|NCT03330236|OG000|Outcome|EEG Guided|"All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.~Anesthetic depth management: The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring."
11322361|NCT03330236|OG001|Outcome|Usual Care|All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
11322362|NCT03330236|EG000|Reported Event|EEG Guided|"All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.~Anesthetic depth management: The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring."
11322363|NCT03330236|EG001|Reported Event|Usual Care|All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
11322364|NCT03330262|BG000|Baseline|BALCAP Prosthesis, Then Control|Participants performed exercises daily at home wearing the BALCAP prosthesis for 6 weeks. After 6 weeks, participants performed the control condition (the same exercises without the BALCAP). Tests were performed before and after each 6-week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
11322365|NCT03330262|BG001|Baseline|Control, Then BALCAP Prosthesis|Participants performed exercises daily at home for 6 weeks without wearing the BALCAP prosthesis (control), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention). Tests were performed before and after each 6 week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
11322366|NCT03330262|BG002|Baseline|Total|Total of all reporting groups
11322367|NCT03330262|FG000|Participant Flow|BALCAP Prosthesis, Then Control|"Participants were asked to perform a series of appropriate exercises daily at home wearing the BALCAP prosthesis for a period of 6 weeks. After the 6 weeks of the BALCAP intervention, participants performed the control condition (the same exercises without the BALCAP worn). Tests were performed before and after each 6 week period.~The training exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.~BALCAP prosthesis: The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane."
11322368|NCT03330262|FG001|Participant Flow|Control, Then BALCAP Prosthesis|"Participants were asked to perform a series of appropriate exercises daily at home for a period of 6 weeks without wearing the BALCAP prosthesis (control condition), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention condition). Tests were performed before and after each 6 week period.~The training exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open."
11322369|NCT03330262|OG000|Outcome|All Participants|All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
11322370|NCT03330262|OG000|Outcome|BALCAP Prosthesis|Participants who wore the BALCAP during exercises for either the first six weeks or the second six weeks of the protocol.
11322371|NCT03330262|OG001|Outcome|Control|Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
11322372|NCT03330262|OG000|Outcome|All Participants|All participants' 25-foot gait speed was measured while wearing the BALCAP prosthetic and while not wearing the BALCAP at baseline.
11322373|NCT03330262|OG001|Outcome|Control|Participants who did not wear the BALCAP during exercises for either the first six weeks or the second six weeks of the protocol.
11322374|NCT03330262|EG000|Reported Event|BALCAP Prosthesis|"Participants will be asked to perform a series of appropriate exercises daily at home wearing the BALCAP prosthesis for a period of 6 weeks. The training exercises will include: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.~BALCAP prosthesis: The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane."
11322375|NCT03330262|EG001|Reported Event|Control|Participants will be asked to perform a series of appropriate exercises daily at home for a period of 6 weeks. The training exercises will include: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.
11322376|NCT03330275|BG000|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
11322377|NCT03330275|FG000|Participant Flow|Test/Control1|Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 1 lens during period 2 of visit 1.
11322378|NCT03330275|FG001|Participant Flow|Control1/Test|Subjects that were randomized to receive the Control 1 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1.
11322379|NCT03330275|FG002|Participant Flow|Test/Control2|Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 2 lens during period 2 of visit 1.
11322380|NCT03330275|FG003|Participant Flow|Control2/Test|Subjects that were randomized to receive the Control 2 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1.
11322381|NCT03330275|FG004|Participant Flow|Test/Control1/Control2|Subjects that were randomized to receive the Test lens during period 1, the Control 1 lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4.
11322382|NCT03330275|FG005|Participant Flow|Test/Control2/Control1|Subjects that were randomized to receive the Test lens during period 1, the Control 2 lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4.
11322383|NCT03330275|FG006|Participant Flow|Control1/Control2/Test|Subjects that were randomized to receive the Control 1 lens during period 1, the Control 2 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4.
11322384|NCT03330275|FG007|Participant Flow|Control1/Test/Control2|Subjects that were randomized to receive the Control 1 lens during period 1, the Test lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4.
11322385|NCT03330275|FG008|Participant Flow|Control2/Control1/Test|Subjects that were randomized to receive the Control 2 lens during period 1, the Control 1 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4.
11322386|NCT03330275|FG009|Participant Flow|Control2/Test/Control1|Subjects that were randomized to receive the Control 2 lens during period 1, the Test lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4.
11322387|NCT03330275|OG000|Outcome|Test|Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
11322388|NCT03330275|OG001|Outcome|Control 1|Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
11322389|NCT03330275|OG002|Outcome|Control 2|Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
11322390|NCT03330275|EG000|Reported Event|Control 1|Subjects that wore the Control 1 lens at any point in the study.
11322391|NCT03330275|EG001|Reported Event|Control 2|Subjects that wore the Control lens at any point in the study.
11322392|NCT03330275|EG002|Reported Event|Test|Subjects that wore the Test lens at any point in the study.
11322393|NCT03330288|BG000|Baseline|Participants With Stage I-III Knee Osteoarthritis (KOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322394|NCT03330288|BG001|Baseline|Participants With Stage I-III Hip Osteoarthritis (HOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322395|NCT03330288|BG002|Baseline|Total|Total of all reporting groups
11322396|NCT03330288|FG000|Participant Flow|Participants With Stage I-III Knee Osteoarthritis (KOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322397|NCT03330288|FG001|Participant Flow|Participants With Stage I-III Hip Osteoarthritis (HOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322398|NCT03330288|OG000|Outcome|Participants With Stage I-III Knee Osteoarthritis (KOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322399|NCT03330288|OG001|Outcome|Participants With Stage I-III Hip Osteoarthritis (HOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322400|NCT03330288|EG000|Reported Event|Participants With Stage I-III Hip Osteoarthritis (HOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322401|NCT03330288|EG001|Reported Event|Participants With Stage I-III Knee Osteoarthritis (KOA)|Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
11322402|NCT03330457|BG000|Baseline|Cohort 1 Bertrixaban/Andexanet|Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322403|NCT03330457|BG001|Baseline|Cohort 1 Bertrixaban/Placebo|Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322404|NCT03330457|BG002|Baseline|Cohort 2 Bertrixaban/Andexanet|Andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322405|NCT03330457|BG003|Baseline|Cohort 2 Bertrixaban/Placebo|Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322406|NCT03330457|BG004|Baseline|Total|Total of all reporting groups
11322407|NCT03330457|FG000|Participant Flow|Cohort 1 Bertrixaban/Andexanet|Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322408|NCT03330457|FG001|Participant Flow|Cohort 1 Bertrixaban/Placebo|Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322409|NCT03330457|FG002|Participant Flow|Cohort 2 Bertrixaban/Andexanet|Andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322410|NCT03330457|FG003|Participant Flow|Cohort 2 Bertrixaban/Placebo|Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322411|NCT03330457|OG000|Outcome|Cohort 1 Bertrixaban/Andexanet|Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322412|NCT03330457|OG001|Outcome|Cohort 1 Bertrixaban/Placebo|Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322413|NCT03330457|OG002|Outcome|Cohort 2 Bertrixaban/Andexanet|Andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322414|NCT03330457|OG003|Outcome|Cohort 2 Bertrixaban/Placebo|Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322415|NCT03330457|EG000|Reported Event|Cohort 1 Bertrixaban/Andexanet|Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322416|NCT03330457|EG001|Reported Event|Cohort 1 Bertrixaban/Placebo|Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days
11322417|NCT03330457|EG002|Reported Event|Cohort 2 Bertrixaban/Andexanet|Andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322418|NCT03330457|EG003|Reported Event|Cohort 2 Bertrixaban/Placebo|Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
11322419|NCT03330834|BG000|Baseline|Treatment Arm|"CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10^6/kg PD-L1 CAR-T cells total.~CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days.~Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells."
11322420|NCT03330834|FG000|Participant Flow|Treatment Arm|"CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10^6/kg PD-L1 CAR-T cells total.~CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days.~Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells."
11322421|NCT03330834|OG000|Outcome|Treatment Arm|"CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10^6/kg PD-L1 CAR-T cells total.~CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days.~Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells."
11322422|NCT03330834|EG000|Reported Event|Treatment Arm|"CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10^6/kg PD-L1 CAR-T cells total.~CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days.~Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells."
11322423|NCT03331042|BG000|Baseline|Sequence 1|"SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322424|NCT03331042|BG001|Baseline|Sequence 2|"D+Z (Treatment Period 1), D+L (Treatment Period 2), Placebo (Treatment Period 3), SM-1 (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322425|NCT03331042|BG002|Baseline|Sequence 3|"D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322426|NCT03331042|BG003|Baseline|Sequence 4|"Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322427|NCT03331042|BG004|Baseline|Total|Total of all reporting groups
11322428|NCT03331042|FG000|Participant Flow|Sequence 1|"SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322429|NCT03331042|FG001|Participant Flow|Sequence 2|"D+Z (Treatment Period 1), D+L (Treatment Period 2), Placebo (Treatment Period 3), SM-1 (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322430|NCT03331042|FG002|Participant Flow|Sequence 3|"D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322431|NCT03331042|FG003|Participant Flow|Sequence 4|"Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4).~SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.~D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.~D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.~Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials."
11322432|NCT03331042|OG000|Outcome|SM-1|Subjects received a single dose of the triple drug combination
11322433|NCT03331042|OG001|Outcome|Diphenhydramine Plus Zolpidem|Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam
11322434|NCT03331042|OG002|Outcome|Diphenhydramine Plus Lorazepam|Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem
11322435|NCT03331042|OG003|Outcome|Placebo|Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
11322436|NCT03331042|OG000|Outcome|SM-1|Triple drug combination
11322437|NCT03331042|OG001|Outcome|Diphenhydramine and Zolpidem|Diphenhydramine and zolpidem
11322438|NCT03331042|OG002|Outcome|Diphenhydramine and Lorazepam|diphenhydramine and lorazepam
11322439|NCT03331042|OG003|Outcome|Placebo|Placebo
11322440|NCT03331042|OG001|Outcome|Diphenhydramine Plus Zolpidem|Diphenhydramine plus Zolpidem
11322441|NCT03331042|OG002|Outcome|Diphenhydramine Plus Lorazepam|Diphenhydramine plus Lorazepam
11322442|NCT03331042|EG000|Reported Event|SM-1|Triple drug combination
11322443|NCT03331042|EG001|Reported Event|Diphenhydramine Plus Zolpidem|Diphenhydramine plus Zolpidem
11322444|NCT03331042|EG002|Reported Event|Diphenhydramine Plus Lorazepam|Diphenhydramine plus Lorazepam
11322445|NCT03331042|EG003|Reported Event|Placebo|Placebo
11322446|NCT03331185|BG000|Baseline|Freeze Dried Bone Allograft|"Socket filled with Mineralized Cortical Freeze Dried Bone Allograft~Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures"
11322447|NCT03331185|BG001|Baseline|L-PRF Clot|"Socket filled with L-PRF Clot~L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues."
11322448|NCT03331185|BG002|Baseline|Total|Total of all reporting groups
11322449|NCT03331185|FG000|Participant Flow|Freeze Dried Bone Allograft|"Socket filled with Mineralized Cortical Freeze Dried Bone Allograft~Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures"
11322450|NCT03331185|FG001|Participant Flow|L-PRF Clot|"Socket filled with L-PRF Clot~L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues."
11322451|NCT03331185|OG000|Outcome|Freeze Dried Bone Allograft|"Socket filled with Mineralized Cortical Freeze Dried Bone Allograft~Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures"
11322452|NCT03331185|OG001|Outcome|L-PRF Clot|"Socket filled with L-PRF Clot~L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues."
11322453|NCT03331185|EG000|Reported Event|Freeze Dried Bone Allograft|"Socket filled with Mineralized Cortical Freeze Dried Bone Allograft~Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures"
11322454|NCT03331185|EG001|Reported Event|L-PRF Clot|"Socket filled with L-PRF Clot~L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues."
11333470|NCT03515824|FG003|Participant Flow|Part B: Expansion Cohort|Participants with select tumor types were to receive MK-1697 at the RP2D by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). No participants were enrolled in this arm.
11333471|NCT03515824|OG000|Outcome|Part A: MK-1697 20 mg|Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333472|NCT03515824|OG001|Outcome|Part A: MK-1697 65 mg|Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333473|NCT03515824|OG002|Outcome|Part A: MK-1697 200 mg|Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333474|NCT03515824|EG000|Reported Event|Part A: MK-1697 20 mg|Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333475|NCT03515824|EG001|Reported Event|Part A: MK-1697 65 mg|Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333476|NCT03515824|EG002|Reported Event|Part A: MK-1697 200 mg|Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
11333477|NCT03515941|BG000|Baseline|Arm 1: Adjuvant Chemotherapy|"Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle~Oxaliplatin: 130 mg/m2 by IV (Arm 1)~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)"
11333478|NCT03515941|BG001|Baseline|Arm 2: Adjuvant Chemoradiation|"Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)~radiation: 45 Gy in 1.8 Gy/fraction"
11333479|NCT03515941|BG002|Baseline|Total|Total of all reporting groups
11333480|NCT03515941|FG000|Participant Flow|Arm 1: Adjuvant Chemotherapy|"Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle~Oxaliplatin: 130 mg/m2 by IV (Arm 1)~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)"
11322455|NCT03331315|BG000|Baseline|Ketorolac|"Patients receiving scheduled ketorolac postoperatively~Ketorolac"
11322456|NCT03331315|BG001|Baseline|Celecoxib|"Patients receiving celebrex preoperative and postoperatively for 7 days~Celecoxib"
11322457|NCT03331315|BG002|Baseline|Total|Total of all reporting groups
11322458|NCT03331315|FG000|Participant Flow|Ketorolac|"Patients receiving scheduled ketorolac postoperatively~Ketorolac"
11322459|NCT03331315|FG001|Participant Flow|Celecoxib|"Patients receiving celebrex preoperative and postoperatively for 7 days~Celecoxib"
11322460|NCT03331315|OG000|Outcome|Ketorolac|"Patients receiving scheduled ketorolac postoperatively~Ketorolac"
11322461|NCT03331315|OG001|Outcome|Celecoxib|"Patients receiving celebrex preoperative and postoperatively for 7 days~Celecoxib"
11322462|NCT03331315|OG000|Outcome|Ketorolac|Participants
11322463|NCT03331315|OG001|Outcome|Celecoxib|Participants
11322464|NCT03331315|EG000|Reported Event|Ketorolac|"Patients receiving scheduled ketorolac postoperatively~Ketorolac"
11322465|NCT03331315|EG001|Reported Event|Celecoxib|"Patients receiving celebrex preoperative and postoperatively for 7 days~Celecoxib"
11322466|NCT03331666|BG000|Baseline|Evolocumab|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322467|NCT03331666|BG001|Baseline|Placebo|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322468|NCT03331666|BG002|Baseline|Total|Total of all reporting groups
11322469|NCT03331666|FG000|Participant Flow|Evolocumab|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322470|NCT03331666|FG001|Participant Flow|Placebo|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322471|NCT03331666|OG000|Outcome|Evolocumab|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322472|NCT03331666|OG001|Outcome|Placebo|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322473|NCT03331666|EG000|Reported Event|Evolocumab|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322474|NCT03331666|EG001|Reported Event|Placebo|"Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.~Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia"
11322475|NCT03331835|BG000|Baseline|Brodalumab|Subcutaneous (s.c.) brodalumab 210 mg once weekly at Weeks 0, 1, and 2, and 210 mg s.c. every 2 weeks.
11322476|NCT03331835|BG001|Baseline|Fumaric Acid Esters|Oral fumaric acid esters up to 240 mg 3 times daily (TID).
11322477|NCT03331835|BG002|Baseline|Total|Total of all reporting groups
11322478|NCT03331835|FG000|Participant Flow|Brodalumab|Kyntheum® (brodalumab) pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections. First 3 injections are administered weekly, and hereafter every two weeks (Q2W).
11322479|NCT03331835|FG001|Participant Flow|Fumaric Acid Esters|"Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt). Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt).~Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label."
11322480|NCT03331835|OG000|Outcome|Brodalumab|Subcutaneous (s.c.) brodalumab 210 mg once weekly at Weeks 0, 1, and 2, and 210 mg s.c. every 2 weeks.
11322481|NCT03331835|OG001|Outcome|Fumaric Acid Esters|Oral fumaric acid esters up to 240 mg 3 times daily (TID).
11322482|NCT03331835|EG000|Reported Event|Brodalumab 210 mg|Kyntheum® (brodalumab) pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections. First 3 injections are administered weekly, and hereafter every two weeks (Q2W).
11322483|NCT03331835|EG001|Reported Event|Fumaric Acid Ester|"Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) > Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt).~Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label."
11322484|NCT03331965|BG000|Baseline|Metoclopramide|"A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Metoclopramide 5 MG/ML Injectable Solution: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement."
11322485|NCT03331965|BG001|Baseline|Saline|"A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Saline: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement."
11322486|NCT03331965|BG002|Baseline|Total|Total of all reporting groups
11322487|NCT03331965|FG000|Participant Flow|Metoclopramide|"A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Metoclopramide 5 MG/ML Injectable Solution: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement."
11322488|NCT03331965|FG001|Participant Flow|Saline|"A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Saline: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement."
11322489|NCT03331965|OG000|Outcome|Metoclopramide|"A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Metoclopramide 5 MG/ML Injectable Solution: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement."
11322490|NCT03331965|OG001|Outcome|Saline|"A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Saline: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement."
11322491|NCT03331965|EG000|Reported Event|Metoclopramide|"A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Metoclopramide 5 MG/ML Injectable Solution: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement."
11322492|NCT03331965|EG001|Reported Event|Saline|"A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.~Saline: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement."
11322493|NCT03332160|BG000|Baseline|Wait-list Control Group|Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate)
11322494|NCT03332160|BG001|Baseline|Interventional Group|Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable
11322495|NCT03332160|BG002|Baseline|Total|Total of all reporting groups
11322496|NCT03332160|FG000|Participant Flow|Wait-list Control Group|Standard home lymphedema care: May include daily self manual lymphatic drainage (MLD), exercise, skincare, compression garments (as appropriate)
11322497|NCT03332160|FG001|Participant Flow|Interventional Group|Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable
11322498|NCT03332160|OG000|Outcome|Interventional Group|Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
11322499|NCT03332160|OG000|Outcome|Wait-list Control Group|Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).
11322500|NCT03332160|OG001|Outcome|Interventional Group|Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
11322501|NCT03332160|EG000|Reported Event|Wait-list Control Group|Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).
11322502|NCT03332160|EG001|Reported Event|Interventional Group|Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
11322503|NCT03332212|BG000|Baseline|Placebo Cohort A|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322504|NCT03332212|BG001|Baseline|Placebo Cohort B|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322505|NCT03332212|BG002|Baseline|Empagliflozin 10mg Cohort A|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322506|NCT03332212|BG003|Baseline|Empagliflozin 10mg Cohort B|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322507|NCT03332212|BG004|Baseline|Total|Total of all reporting groups
11322508|NCT03332212|FG000|Participant Flow|Placebo Cohort A|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322509|NCT03332212|FG001|Participant Flow|Placebo Cohort B|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322510|NCT03332212|FG002|Participant Flow|Empagliflozin 10mg Cohort A|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322511|NCT03332212|FG003|Participant Flow|Empagliflozin 10mg Cohort B|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322512|NCT03332212|OG000|Outcome|Placebo Cohort A|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322513|NCT03332212|OG001|Outcome|Placebo Cohort B|"Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322514|NCT03332212|OG002|Outcome|Empagliflozin 10mg Cohort A|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF)."
11322515|NCT03332212|OG003|Outcome|Empagliflozin 10mg Cohort B|"Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks.~Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF)."
11322516|NCT03332212|EG000|Reported Event|Placebo|Once a day oral administration of a single film-coated placebo tablet matching to empagliflozin for 12 weeks. Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF) and Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF).
11322517|NCT03332212|EG001|Reported Event|Empagliflozin 10mg|Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks. Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF) and Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF).
11322518|NCT03332459|BG000|Baseline|Placebo|Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322519|NCT03332459|BG001|Baseline|Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)|Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322520|NCT03332459|BG002|Baseline|Lumicitabine 60/40 mg/kg LD/MD|Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322521|NCT03332459|BG003|Baseline|Total|Total of all reporting groups
11322522|NCT03332459|FG000|Participant Flow|Placebo|Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322523|NCT03332459|FG001|Participant Flow|Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)|Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322524|NCT03332459|FG002|Participant Flow|Lumicitabine 60/40 mg/kg LD/MD|Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322525|NCT03332459|OG000|Outcome|Placebo|Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11335987|NCT03559218|EG001|Reported Event|KeraStat Cream|"Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.~KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin."
11335988|NCT03559257|BG000|Baseline|Placebo/Galcanezumab 120mg|Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period.
11322526|NCT03332459|OG001|Outcome|Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)|Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322527|NCT03332459|OG002|Outcome|Lumicitabine 60/40 mg/kg LD/MD|Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322528|NCT03332459|EG000|Reported Event|Placebo|Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322529|NCT03332459|EG001|Reported Event|Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)|Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322530|NCT03332459|EG002|Reported Event|Lumicitabine 60/40 mg/kg LD/MD|Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
11322531|NCT03332628|BG000|Baseline|Microneedle Application|"This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis.~Microneedle patch: Each patch contains 50 microneedles."
11322532|NCT03332628|FG000|Participant Flow|Microneedle Application|"This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis.~Microneedle patch: Each patch contains 50 microneedles."
11322533|NCT03332628|OG000|Outcome|Microneedle Application|"This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. The 9 sites will be divided into 3 clusters of 3 sites each. Baseline measurements of hydration and color will be made at each site. The first site cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. Measurements of transepidermal water loss and impedance will be made before and after the microneedle treatments at these 3 sites. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be measured daily for 4 consecutive days after microneedle application. Measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis.~Microneedle patch: Each patch contains 50 microneedles."
11322534|NCT03332628|OG000|Outcome|Microneedle Application|"This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis.~Microneedle patch: Each patch contains 50 microneedles."
11322535|NCT03332628|EG000|Reported Event|Microneedle Application|"This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis.~Microneedle patch: Each patch contains 50 microneedles."
11322536|NCT03332771|BG000|Baseline|Placebo|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322537|NCT03332771|BG001|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322538|NCT03332771|BG002|Baseline|Sotagliflozin 200 mg|Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322539|NCT03332771|BG003|Baseline|Glimepiride|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322540|NCT03332771|BG004|Baseline|Total|Total of all reporting groups
11322541|NCT03332771|FG000|Participant Flow|Placebo|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322542|NCT03332771|FG001|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322543|NCT03332771|FG002|Participant Flow|Sotagliflozin 200 mg|Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322544|NCT03332771|FG003|Participant Flow|Glimepiride|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322545|NCT03332771|OG000|Outcome|Placebo|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322546|NCT03332771|OG001|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322547|NCT03332771|OG002|Outcome|Sotagliflozin 200 mg|Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322548|NCT03332771|OG003|Outcome|Glimepiride|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322549|NCT03332771|EG000|Reported Event|Placebo|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322550|NCT03332771|EG001|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322551|NCT03332771|EG002|Reported Event|Sotagliflozin 200 mg|Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322552|NCT03332771|EG003|Reported Event|Glimepiride|Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
11322553|NCT03332784|BG000|Baseline|Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.
11322554|NCT03332784|BG001|Baseline|Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo|TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.
11322555|NCT03332784|BG002|Baseline|Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.
11322556|NCT03332784|BG003|Baseline|Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.
11322557|NCT03332784|BG004|Baseline|Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.
11322558|NCT03332784|BG005|Baseline|Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.
11322559|NCT03332784|BG006|Baseline|Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.
11322560|NCT03332784|BG007|Baseline|Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.
11322561|NCT03332784|BG008|Baseline|Part 1 Cohort S1-S2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322562|NCT03332784|BG009|Baseline|Part 1: Cohort S1 TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.
11322563|NCT03332784|BG010|Baseline|Part 1: Cohort S2 TAK-925 240 mg|TAK-925 240 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.
11322564|NCT03332784|BG011|Baseline|Part 1: Cohort 3 Placebo|TAK-925 placebo-matching infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.
11322565|NCT03332784|BG012|Baseline|Part 1: Cohort 3 TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.
11322566|NCT03332784|BG013|Baseline|Part 1: Cohort 4 TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in unblinded manner.
11322567|NCT03332784|BG014|Baseline|Part 2 Cohort 5: TAK-925 44.8 mg + Placebo|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322568|NCT03332784|BG015|Baseline|Part 2 Cohort 5, Part J: TAK-925 Placebo + 44.8 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322569|NCT03332784|BG016|Baseline|Part 2 Cohort 6: TAK-925 11.2 mg + Placebo|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322570|NCT03332784|BG017|Baseline|Part 2 Cohort 6: Placebo + TAK-925 11.2 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322571|NCT03332784|BG018|Baseline|Part 2 Cohort 7: TAK-925 5 mg + Placebo|TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322572|NCT03332784|BG019|Baseline|Part 2 Cohort 7: Placebo + TAK-925 5 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
11322573|NCT03332784|BG020|Baseline|Total|Total of all reporting groups
11322574|NCT03332784|FG000|Participant Flow|Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg|TAK-925 7 milligram (mg), infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.
11322575|NCT03332784|FG001|Participant Flow|Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo|TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.
11322576|NCT03332784|FG002|Participant Flow|Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.
11322577|NCT03332784|FG003|Participant Flow|Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.
11322578|NCT03332784|FG004|Participant Flow|Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.
11335989|NCT03559257|BG001|Baseline|Galcanezumab 120mg|Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period.
11322579|NCT03332784|FG005|Participant Flow|Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.
11322580|NCT03332784|FG006|Participant Flow|Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.
11322581|NCT03332784|FG007|Participant Flow|Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.
11322582|NCT03332784|FG008|Participant Flow|Part 1 Cohort S1-S2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322583|NCT03332784|FG009|Participant Flow|Part 1 Cohort S1: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322584|NCT03332784|FG010|Participant Flow|Part 1 Cohort S2: TAK-925 240 mg|TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322585|NCT03332784|FG011|Participant Flow|Part 1 Cohort 3: Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322586|NCT03332784|FG012|Participant Flow|Part 1 Cohort 3: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322587|NCT03332784|FG013|Participant Flow|Part 1 Cohort 4: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
11322588|NCT03332784|FG014|Participant Flow|Part 2 Cohort 5: TAK-925 44.8 mg + Placebo|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322589|NCT03332784|FG015|Participant Flow|Part 2 Cohort 5: Placebo + TAK-925 44.8 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322590|NCT03332784|FG016|Participant Flow|Part 2 Cohort 6: TAK-925 11.2 mg + Placebo|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322591|NCT03332784|FG017|Participant Flow|Part 2 Cohort 6: Placebo + TAK-925 11.2 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322592|NCT03332784|FG018|Participant Flow|Part 2 Cohort 7: TAK-925 5 mg + Placebo|TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
11322593|NCT03332784|FG019|Participant Flow|Part 2 Cohort 7: Placebo + TAK-925 5 mg|TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
11322594|NCT03332784|OG000|Outcome|Part 1 Cohort 1-2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.
11322595|NCT03332784|OG001|Outcome|Part 1 Cohort 1: TAK-925 7 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322596|NCT03332784|OG002|Outcome|Part 1 Cohort 2: TAK-925 14 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322597|NCT03332784|OG003|Outcome|Part 1 Cohort 1: TAK-925 28 mg|TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322598|NCT03332784|OG004|Outcome|Par 1 Cohort 2: TAK-925 56 mg|TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322599|NCT03332784|OG005|Outcome|Part 1 Cohort 1: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322600|NCT03332784|OG006|Outcome|Part 1 Cohort 2: TAK-925 134.4 mg|TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322601|NCT03332784|OG007|Outcome|Part 1 Cohort S1-S2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322602|NCT03332784|OG008|Outcome|Part 1 Cohort S1: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322603|NCT03332784|OG009|Outcome|Part 1 Cohort S2: TAK-925 240 mg|TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322604|NCT03332784|OG010|Outcome|Part 1 Cohort 3: Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322605|NCT03332784|OG011|Outcome|Part 1 Cohort 3: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322606|NCT03332784|OG012|Outcome|Part 1 Cohort 4: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
11322607|NCT03332784|OG013|Outcome|Part 2 Cohort 5-7: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
11322608|NCT03332784|OG014|Outcome|Part 2 Cohort 5: TAK-925 44.8 mg|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322609|NCT03332784|OG015|Outcome|Part 2 Cohort 6: TAK-925 11.2 mg|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322610|NCT03332784|OG016|Outcome|Part 2 Cohort 7: TAK-925 5 mg|TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322611|NCT03332784|OG000|Outcome|Part 1 Cohort 1: TAK-925 7 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322612|NCT03332784|OG001|Outcome|Part 1 Cohort 2: TAK-925 14 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322613|NCT03332784|OG002|Outcome|Part 1 Cohort 1: TAK-925 28 mg|TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322614|NCT03332784|OG003|Outcome|Par 1 Cohort 2: TAK-925 56 mg|TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322615|NCT03332784|OG004|Outcome|Part 1 Cohort 1: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322616|NCT03332784|OG005|Outcome|Part 1 Cohort 2: TAK-925 134.4 mg|TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322617|NCT03332784|OG006|Outcome|Part 1 Cohort S1: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322618|NCT03332784|OG007|Outcome|Part 1 Cohort S2: TAK-925 240 mg|TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322619|NCT03332784|OG008|Outcome|Part 1 Cohort 3: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322620|NCT03332784|OG009|Outcome|Part 1 Cohort 4: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
11322621|NCT03332784|OG000|Outcome|Part 2 Cohort 5: TAK-925 44.8 mg|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322622|NCT03332784|OG001|Outcome|Part 2 Cohort 6: TAK-925 11.2 mg|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322623|NCT03332784|OG002|Outcome|Part 2 Cohort 7: TAK-925 5 mg|TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322624|NCT03332784|OG000|Outcome|Part 1 Cohort 4: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
11322625|NCT03332784|OG000|Outcome|Part 2 Cohort 5-7: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
11322626|NCT03332784|OG001|Outcome|Part 2 Cohort 5: TAK-925 44.8 mg|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322627|NCT03332784|OG002|Outcome|Part 2 Cohort 6: TAK-925 11.2 mg|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322628|NCT03332784|OG003|Outcome|Part 2 Cohort 7: TAK-925 5 mg|TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322629|NCT03332784|EG000|Reported Event|Part 1 Cohort 1-2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.
11322630|NCT03332784|EG001|Reported Event|Part 1 Cohort 1: TAK-925 7 mg|TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322631|NCT03332784|EG002|Reported Event|Part 1 Cohort 2: TAK-925 14 mg|TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322632|NCT03332784|EG003|Reported Event|Part 1 Cohort 1: TAK-925 28 mg|TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322633|NCT03332784|EG004|Reported Event|Par 1 Cohort 2: TAK-925 56 mg|TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322634|NCT03332784|EG005|Reported Event|Part 1 Cohort 1: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
11322635|NCT03332784|EG006|Reported Event|Part 1 Cohort 2: TAK-925 134.4 mg|TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
11322636|NCT03332784|EG007|Reported Event|Part 1 Cohort S1-S2: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322637|NCT03332784|EG008|Reported Event|Part 1 Cohort S1: TAK-925 180 mg|TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322638|NCT03332784|EG009|Reported Event|Part 1 Cohort S2: TAK-925 240 mg|TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
11322639|NCT03332784|EG010|Reported Event|Part 1 Cohort 3: Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322640|NCT03332784|EG011|Reported Event|Part 1 Cohort 3: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
11322641|NCT03332784|EG012|Reported Event|Part 1 Cohort 4: TAK-925 112 mg|TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
11322642|NCT03332784|EG013|Reported Event|Part 2 Cohort 5-7: Pooled Placebo|TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
11322643|NCT03332784|EG014|Reported Event|Part 2 Cohort 5: TAK-925 44.8 mg|TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322644|NCT03332784|EG015|Reported Event|Part 2 Cohort 6: TAK-925 11.2 mg|TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322645|NCT03332784|EG016|Reported Event|Part 2 Cohort 7: TAK-925 5 mg|TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
11322646|NCT03332979|BG000|Baseline|All Study Participants|All Study Participants/Usual care
11322647|NCT03332979|FG000|Participant Flow|All Study Participants|All Study Participants/Usual care
11322648|NCT03332979|OG000|Outcome|All Study Participants|All Study Participants/Usual care
11322649|NCT03332979|EG000|Reported Event|All Study Participants|All Study Participants/ Usual care
11322650|NCT03333109|BG000|Baseline|AMG334 70 mg|AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
11322651|NCT03333109|BG001|Baseline|AMG334 140 mg|AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
11322652|NCT03333109|BG002|Baseline|Placebo|Two pre-filled syringes containing placebo identical in appearance to erenumab
11322653|NCT03333109|BG003|Baseline|Total|Total of all reporting groups
11322654|NCT03333109|FG000|Participant Flow|AMG334 70 mg|AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
11322655|NCT03333109|FG001|Participant Flow|AMG334 140 mg|AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
11322656|NCT03333109|FG002|Participant Flow|Placebo|Two pre-filled syringes containing placebo identical in appearance to erenumab
11322657|NCT03333109|OG000|Outcome|AMG334 70 mg|AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
11322658|NCT03333109|OG001|Outcome|AMG334 140 mg|AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
11322659|NCT03333109|OG002|Outcome|Placebo|Two pre-filled syringes containing placebo identical in appearance to erenumab
11322660|NCT03333109|EG000|Reported Event|AMG 334 70mg|AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
11322661|NCT03333109|EG001|Reported Event|AMG 334 140mg|AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
11322662|NCT03333109|EG002|Reported Event|Placebo|Two pre-filled syringes containing placebo identical in appearance to erenumab
11322663|NCT03333317|BG000|Baseline|Placebo|Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
11322664|NCT03333317|BG001|Baseline|Lumicitabine 40/20 mg/kg LD/MD|Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
11322665|NCT03333317|BG002|Baseline|Lumicitabine 60/40 mg/kg LD/MD|Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
11322666|NCT03333317|BG003|Baseline|Total|Total of all reporting groups
11322667|NCT03333317|FG000|Participant Flow|Placebo|Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
11322668|NCT03333317|FG001|Participant Flow|Lumicitabine 40/20 mg/kg LD/MD|Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
11322669|NCT03333317|FG002|Participant Flow|Lumicitabine 60/40 mg/kg LD/MD|Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
11322670|NCT03333317|OG000|Outcome|Placebo|Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
11322671|NCT03333317|OG001|Outcome|Lumicitabine 40/20 mg/kg LD/MD|Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
11322672|NCT03333317|OG002|Outcome|Lumicitabine 60/40 mg/kg LD/MD|Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
11322673|NCT03333317|OG000|Outcome|Lumicitabine 40/20 mg/kg LD/MD|Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
11322674|NCT03333317|OG001|Outcome|Lumicitabine 60/40 mg/kg LD/MD|Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
11322675|NCT03333317|EG000|Reported Event|Placebo|Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
11322676|NCT03333317|EG001|Reported Event|Lumicitabine 40/20 mg/kg LD/MD|Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
11322677|NCT03333317|EG002|Reported Event|Lumicitabine 60/40 mg/kg LD/MD|Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
11322678|NCT03333577|BG000|Baseline|Experimental SoundArc Study Group|"all subjects will receive the SoundArc intervention~SoundArc: non-surgical attachment method for wearing a bone conduction hearing system"
11322679|NCT03333577|FG000|Participant Flow|Experimental SoundArc Study Group|"all subjects will receive the SoundArc intervention~SoundArc: non-surgical attachment method for wearing a bone conduction hearing system"
11322680|NCT03333577|OG000|Outcome|Experimental SoundArc Study Group|"all subjects will receive the SoundArc intervention~SoundArc: non-surgical attachment method for wearing a bone conduction hearing system"
11322681|NCT03333577|EG000|Reported Event|Experimental SoundArc Study Group|"all subjects will receive the SoundArc intervention~SoundArc: non-surgical attachment method for wearing a bone conduction hearing system"
11322682|NCT03333876|BG000|Baseline|Snorers|All participants that entered the study that were considered snorers.
11322683|NCT03333876|BG001|Baseline|Bed Partners|All participants that entered the study that were considered bed partners.
11322684|NCT03333876|BG002|Baseline|Total|Total of all reporting groups
11322685|NCT03333876|FG000|Participant Flow|All Study Participants|All study participants that consented are included in the participant flow.
11322686|NCT03333876|OG000|Outcome|Nasal Dilator|"Nasal dilators have been used to treat snoring and sleep apnea. Many studies focus on external nasal dilators like Breathe Right Strips. These interventions largely were not effective in treating Obstructive Sleep Apnea (OSA). However, there is some evidence to suggest internal to the nose dilators (like Mute) may work to reduce snoring.~Nasal Dilator: Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/."
11322687|NCT03333876|OG001|Outcome|Mandibular Advancement|"Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.~Mandibular Advancement: For purposes of this trial, we will be using an investigational myTAP V, which is not available for commercial use. The changes from the released product are: a vertical offset (+3mm) has been added to the design of the adjustment post and mechanism to improve overall comfort.~myTAPTM is a mandibular advancement device used for snoring relief. The product requires a prescription and is cleared by FDA for use in the United States."
11322688|NCT03333876|OG002|Outcome|Positional Therapy|Positional Therapy was conducted with a Sleep Positional Trainer (SPT) is a small device worn around the chest with an ergonomic band that continuously monitors the sleep position of the snorer. When the snorer is supine, it emits a gentle vibration to remind them to turn to the side to help reduce or eliminate their snoring.
11322689|NCT03333876|OG000|Outcome|Nasal Dilator|"Nasal dilators have been used to treat snoring and sleep apnea. Many studies focus on external nasal dilators like Breathe Right Strips. These interventions largely were not effective in treating OSA. However, there is some evidence to suggest internal to the nose dilators (like Mute) may work to reduce snoring.~Nasal Dilator: Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/."
11322690|NCT03333876|OG000|Outcome|Baseline|All participants that entered the study were to complete a baseline period of 3 nights in which no intervention was used, but sleep was recorded.
11322691|NCT03333876|OG001|Outcome|Nasal Dilator|"Nasal dilators have been used to treat snoring and sleep apnea. Many studies focus on external nasal dilators like Breathe Right Strips. These interventions largely were not effective in treating OSA. However, there is some evidence to suggest internal to the nose dilators (like Mute) may work to reduce snoring.~Nasal Dilator: Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/."
11322692|NCT03333876|OG002|Outcome|Mandibular Advancement|"Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.~Mandibular Advancement: For purposes of this trial, we will be using an investigational myTAP V, which is not available for commercial use. The changes from the released product are: a vertical offset (+3mm) has been added to the design of the adjustment post and mechanism to improve overall comfort.~myTAPTM is a mandibular advancement device used for snoring relief. The product requires a prescription and is cleared by FDA for use in the United States."
11322693|NCT03333876|OG003|Outcome|Positional Therapy|Positional Therapy was conducted with a Sleep Positional Trainer (SPT) is a small device worn around the chest with an ergonomic band that continuously monitors the sleep position of the snorer. When the snorer is supine, it emits a gentle vibration to remind them to turn to the side to help reduce or eliminate their snoring.
11322694|NCT03333876|EG000|Reported Event|Nasal Dilator|"Nasal dilators have been used to treat snoring and sleep apnea. Many studies focus on external nasal dilators like Breathe Right Strips. These interventions largely were not effective in treating OSA. However, there is some evidence to suggest internal to the nose dilators (like Mute) may work to reduce snoring.~Nasal Dilator: Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/."
11322695|NCT03333876|EG001|Reported Event|Mandibular Advancement|"Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.~Mandibular Advancement: For purposes of this trial, we will be using an investigational myTAP V, which is not available for commercial use. The changes from the released product are: a vertical offset (+3mm) has been added to the design of the adjustment post and mechanism to improve overall comfort.~myTAPTM is a mandibular advancement device used for snoring relief. The product requires a prescription and is cleared by FDA for use in the United States."
11322696|NCT03333876|EG002|Reported Event|Positional Therapy|"Studies have shown mixed results for positional therapy as a whole. Braver and Block reported that foam wedges used to keep patients in a lateral position were not effective in reducing snoring in 20 individuals.~Positional Therapy: Sleep Positional Trainer (SPT) is a small device worn around the chest with an ergonomic band that continuously monitors the sleep position of the snorer. When the snorer is supine, it emits a gentle vibration to remind them to turn to the side to help reduce or eliminate their snoring."
11335990|NCT03559257|BG002|Baseline|Total|Total of all reporting groups
11322697|NCT03333941|BG000|Baseline|RES (Regenerative Epithelial Suspension)|ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
11322698|NCT03333941|FG000|Participant Flow|RES (Regenerative Epithelial Suspension)|ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
11322699|NCT03333941|OG000|Outcome|RES (Regenerative Epithelial Suspension)|ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
11322700|NCT03333941|EG000|Reported Event|RES (Regenerative Epithelial Suspension)|ReCell® Autologous Cell Harvesting Device: RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
11322701|NCT03334175|BG000|Baseline|Walnuts Now|"Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.~Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food."
11322702|NCT03334175|BG001|Baseline|Walnuts Later|Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
11322703|NCT03334175|BG002|Baseline|Total|Total of all reporting groups
11322704|NCT03334175|FG000|Participant Flow|Walnuts Now|"Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.~Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food."
11322705|NCT03334175|FG001|Participant Flow|Walnuts Later|Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
11322706|NCT03334175|OG000|Outcome|Walnuts Now|"Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.~Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food."
11322707|NCT03334175|OG001|Outcome|Walnuts Later|Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
11322708|NCT03334175|EG000|Reported Event|Walnuts Now|"Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.~Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food."
11322709|NCT03334175|EG001|Reported Event|Walnuts Later|Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
11322710|NCT03334188|BG000|Baseline|Control|"Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'.~No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm."
11322711|NCT03334188|BG001|Baseline|Intervention|"Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'~Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist."
11322712|NCT03334188|BG002|Baseline|Total|Total of all reporting groups
11322713|NCT03334188|FG000|Participant Flow|Control|"Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include 'No Intervention--Usual Care'.~No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm."
11322714|NCT03334188|FG001|Participant Flow|Intervention|"Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'~Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist."
11335991|NCT03559257|FG000|Participant Flow|Placebo/Galcanezumab 120mg|Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period.
11322715|NCT03334188|OG000|Outcome|Control|"Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'.~No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm."
11322716|NCT03334188|OG001|Outcome|Intervention|"Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'~Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist."
11322717|NCT03334188|OG000|Outcome|Intervention - Only|"Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'~Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist."
11322718|NCT03334188|EG000|Reported Event|Control|"Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'.~No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm."
11322719|NCT03334188|EG001|Reported Event|Intervention|"Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'~Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist."
11322720|NCT03334214|BG000|Baseline|Placebo|Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks.
11322721|NCT03334214|BG001|Baseline|IONIS DGAT2Rx 250 mg|Single dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks.
11322722|NCT03334214|BG002|Baseline|Total|Total of all reporting groups
11322723|NCT03334214|FG000|Participant Flow|Placebo|Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks.
11322724|NCT03334214|FG001|Participant Flow|IONIS DGAT2Rx 250 mg|Single dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks.
11322725|NCT03334214|OG000|Outcome|Placebo|Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks
11322726|NCT03334214|OG001|Outcome|IONIS DGAT2Rx 250 mg|Single dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks.
11322727|NCT03334214|OG000|Outcome|Placebo|Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks.
11322728|NCT03334214|EG000|Reported Event|Placebo|Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks.
11322729|NCT03334214|EG001|Reported Event|IONIS DGAT2Rx 250 mg|Single dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks.
11322730|NCT03334396|BG000|Baseline|Placebo|Placebo administered orally once daily.
10843009|NCT00251316|EG000|Reported Event|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
11322731|NCT03334396|BG001|Baseline|1 mg Baricitinib|1 mg Baricitinib administered orally once daily.
11322732|NCT03334396|BG002|Baseline|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11322733|NCT03334396|BG003|Baseline|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11322734|NCT03334396|BG004|Baseline|Placebo Maximum Extended Enrollment (MEE)|Placebo administered orally once daily.
11322735|NCT03334396|BG005|Baseline|1 mg Baricitinib MEE|1 mg Baricitinib administered orally once daily. .
11322736|NCT03334396|BG006|Baseline|2 mg Baricitinib MEE|2 mg Baricitinib administered orally once daily.
11322737|NCT03334396|BG007|Baseline|4 mg Baricitinib MEE|4 mg Baricitinib administered orally once daily.
11322738|NCT03334396|BG008|Baseline|Total|Total of all reporting groups
11322739|NCT03334396|FG000|Participant Flow|Placebo|Placebo administered orally once daily.
11322740|NCT03334396|FG001|Participant Flow|1 mg Baricitinib|1 mg Baricitinib administered orally once daily.
11322741|NCT03334396|FG002|Participant Flow|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11322742|NCT03334396|FG003|Participant Flow|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11322743|NCT03334396|FG004|Participant Flow|Placebo Maximum Extended Enrollment (MEE)|Placebo administered orally once daily.
11217934|NCT02317614|EG000|Reported Event|SteadyRx|"This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.~SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load."
11217935|NCT02317614|EG001|Reported Event|Usual Care|This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
11217936|NCT02317692|BG000|Baseline|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
11217937|NCT02317692|BG001|Baseline|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
11217938|NCT02317692|BG002|Baseline|Total|Total of all reporting groups
11217939|NCT02317692|FG000|Participant Flow|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
11217940|NCT02317692|FG001|Participant Flow|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
11217941|NCT02317692|OG000|Outcome|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
11217942|NCT02317692|OG001|Outcome|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
11217943|NCT02317692|EG000|Reported Event|Standard ADHD Parent Training|"8 sessions of evidence-based parent training plus school intervention~Parent training"
11217944|NCT02317692|EG001|Reported Event|Culturally-modified ADHD Parent Training|"8 sessions of culturally-modified parent training plus school intervention~Parent training"
11217945|NCT02317744|BG000|Baseline|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
11217946|NCT02317744|BG001|Baseline|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
11217947|NCT02317744|BG002|Baseline|Total|Total of all reporting groups
11217948|NCT02317744|FG000|Participant Flow|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
11217949|NCT02317744|FG001|Participant Flow|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
11217950|NCT02317744|OG000|Outcome|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
11217951|NCT02317744|OG001|Outcome|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
11217952|NCT02317744|EG000|Reported Event|Naltrexone/ Bupropion Combination|"50 mg naltrexone and 300 mg bupropion per day for 3 months~Naltrexone and bupropion combination"
11217953|NCT02317744|EG001|Reported Event|Pill Placebo|"Daily placebo medication for 3 months~Pill Placebo"
11217954|NCT02317809|BG000|Baseline|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
11217955|NCT02317809|FG000|Participant Flow|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11217956|NCT02317809|FG001|Participant Flow|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11217957|NCT02317809|OG000|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11217958|NCT02317809|OG001|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11217959|NCT02317809|OG000|Outcome|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11217960|NCT02317809|OG001|Outcome|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11217961|NCT02317809|OG000|Outcome|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
11217962|NCT02317809|EG000|Reported Event|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11217963|NCT02317809|EG001|Reported Event|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11217964|NCT02318134|BG000|Baseline|FMT Group|In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
11217965|NCT02318134|BG001|Baseline|Control Group|In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
11217966|NCT02318134|BG002|Baseline|Total|Total of all reporting groups
11217967|NCT02318134|FG000|Participant Flow|FMT Group|In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
11217968|NCT02318134|FG001|Participant Flow|Control Group|In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
11217969|NCT02318134|OG000|Outcome|FMT Group|In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
11217970|NCT02318134|OG001|Outcome|Control Group|In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
11217971|NCT02318134|OG000|Outcome|Control Group|"In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.~normal saline: Normal saline via a nasoduodenal tube."
11217972|NCT02318134|OG001|Outcome|FMT Group|"In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.~Fecal Microbiota Transplantation: FMT via a nasoduodenal tube with fresh bacteria from healthy donor"
11217973|NCT02318134|EG000|Reported Event|FMT Group|In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
11217974|NCT02318134|EG001|Reported Event|Control Group|In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
11217975|NCT02318303|BG000|Baseline|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
11217976|NCT02318303|BG001|Baseline|GSP 301-1 NS (QD)|GSP 301-1 NS administered as 2 sprays/nostril
11217977|NCT02318303|BG002|Baseline|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS administered as 2 sprays/nostril
11217978|NCT02318303|BG003|Baseline|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS administered as 2 sprays/nostril
11217979|NCT02318303|BG004|Baseline|GSP 301-2 NS (BID)|GSP 301-2 NS administered as 2 sprays/nostril
11217980|NCT02318303|BG005|Baseline|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS administered as 2 sprays/nostril
11217981|NCT02318303|BG006|Baseline|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS administered as 2 sprays/nostril
11217982|NCT02318303|BG007|Baseline|Total|Total of all reporting groups
11217983|NCT02318303|FG000|Participant Flow|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
11217984|NCT02318303|FG001|Participant Flow|GSP 301-1 NS (QD)|GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
11217985|NCT02318303|FG002|Participant Flow|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril
11217986|NCT02318303|FG003|Participant Flow|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
11217987|NCT02318303|FG004|Participant Flow|GSP 301-2 NS (BID)|GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
11217988|NCT02318303|FG005|Participant Flow|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
11217989|NCT02318303|FG006|Participant Flow|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
11217990|NCT02318303|OG000|Outcome|GSP 301 Placebo|GSP 301 placebo NS administered as 2 sprays/nostril
11217991|NCT02318303|OG001|Outcome|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
11217992|NCT02318303|OG002|Outcome|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
11217993|NCT02318303|OG003|Outcome|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
11217994|NCT02318303|OG004|Outcome|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril
11217995|NCT02318303|OG005|Outcome|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
11217996|NCT02318303|OG006|Outcome|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
11217997|NCT02318303|EG000|Reported Event|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
11217998|NCT02318303|EG001|Reported Event|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
11217999|NCT02318303|EG002|Reported Event|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
11218000|NCT02318303|EG003|Reported Event|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
11218001|NCT02318303|EG004|Reported Event|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril.
11218002|NCT02318303|EG005|Reported Event|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
11218003|NCT02318303|EG006|Reported Event|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
11218004|NCT02318368|BG000|Baseline|Ficlatuzumab Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11322744|NCT03334396|FG005|Participant Flow|1 mg Baricitinib MEE|1 mg Baricitinib administered orally once daily.
11322745|NCT03334396|FG006|Participant Flow|2 mg Baricitinib MEE|2 mg Baricitinib administered orally once daily.
11322746|NCT03334396|FG007|Participant Flow|4 mg Baricitinib MEE|4 mg Baricitinib administered orally once daily.
11322747|NCT03334396|OG000|Outcome|Placebo|Placebo administered orally once daily.
11322748|NCT03334396|OG001|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11322749|NCT03334396|OG002|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11218005|NCT02318368|BG001|Baseline|Placebo Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218006|NCT02318368|BG002|Baseline|Total|Total of all reporting groups
11218007|NCT02318368|FG000|Participant Flow|Ficlatuzumab Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218008|NCT02318368|FG001|Participant Flow|Placebo Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218009|NCT02318368|OG000|Outcome|Ficlatuzumab Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218010|NCT02318368|OG001|Outcome|Placebo Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218011|NCT02318368|EG000|Reported Event|Ficlatuzumab Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218012|NCT02318368|EG001|Reported Event|Placebo Plus Erlotinib|Participants received 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
11218013|NCT02318550|BG000|Baseline|Single Arm: Received MRI|This group received an MRI and pre- and post-imaging device checks.
11218014|NCT02318550|FG000|Participant Flow|Single Arm: Received MRI|This group received an MRI and pre- and post-imaging device checks.
11218015|NCT02318550|OG000|Outcome|Single Arm: Received MRI|This group received an MRI and pre- and post-imaging device checks.
11218016|NCT02318550|EG000|Reported Event|Single Arm: Received MRI|This group received an MRI and pre- and post-imaging device checks.
11218017|NCT02318602|BG000|Baseline|Infants|"Participants 1 to <2 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218018|NCT02318602|BG001|Baseline|Children|"Participants 2 to <12 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218019|NCT02318602|BG002|Baseline|Adolescents|"Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218020|NCT02318602|BG003|Baseline|Total|Total of all reporting groups
11218021|NCT02318602|FG000|Participant Flow|Infants|"Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218022|NCT02318602|FG001|Participant Flow|Children|"Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11322750|NCT03334396|OG001|Outcome|1 mg Baricitinib|1 mg Baricitinib administered orally once daily.
11322751|NCT03334396|OG002|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11322752|NCT03334396|OG003|Outcome|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11322753|NCT03334396|OG002|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally once daily..
11322754|NCT03334396|EG000|Reported Event|Placebo|Placebo administered orally once daily.
11322755|NCT03334396|EG001|Reported Event|1 mg Baricitinib|1 mg Baricitinib administered orally once daily.
11322756|NCT03334396|EG002|Reported Event|2 mg Baricitinib|2 mg Baricitinib administered orally once daily.
11322757|NCT03334396|EG003|Reported Event|4 mg Baricitinib|4 mg Baricitinib administered orally once daily.
11322758|NCT03334396|EG004|Reported Event|Placebo Maximum Extended Enrollment|Placebo administered orally once daily.
11322759|NCT03334396|EG005|Reported Event|1 mg Baricitinib Maximum Extended Enrollment|1 mg Baricitinib administered orally once daily.
11322760|NCT03334396|EG006|Reported Event|2 mg Baricitinib Maximum Extended Enrollment|2 mg Baricitinib administered orally once daily.
11322761|NCT03334396|EG007|Reported Event|4 mg Baricitinib Maximum Extended Enrollment|4 mg Baricitinib administered orally once daily.
11322762|NCT03334422|BG000|Baseline|Placebo|Placebo administered orally once daily.
11322763|NCT03334422|BG001|Baseline|1mg Baricitinib|1 milligram (mg) Baricitinib administered orally once daily.
11322764|NCT03334422|BG002|Baseline|2mg Baricitinib|2mg Baricitinib administered orally once daily.
11322765|NCT03334422|BG003|Baseline|4mg Baricitinib|4mg Baricitinib administered orally once daily.
11322766|NCT03334422|BG004|Baseline|Total|Total of all reporting groups
11322767|NCT03334422|FG000|Participant Flow|Placebo|Placebo administered orally once daily.
11322768|NCT03334422|FG001|Participant Flow|1mg Baricitinib|1 milligram (mg) Baricitinib administered orally once daily.
11322769|NCT03334422|FG002|Participant Flow|2mg Baricitinib|2mg Baricitinib administered orally once daily.
11322770|NCT03334422|FG003|Participant Flow|4mg Baricitinib|4mg Baricitinib administered orally once daily.
11322771|NCT03334422|OG000|Outcome|Placebo|Placebo administered orally once daily.
11322772|NCT03334422|OG001|Outcome|2mg Baricitinib|2mg Baricitinib administered orally once daily.
11322773|NCT03334422|OG002|Outcome|4mg Baricitinib|4mg Baricitinib administered orally once daily.
11322774|NCT03334422|OG001|Outcome|1mg Baricitinib|1 milligram (mg) Baricitinib administered orally once daily.
11322775|NCT03334422|OG001|Outcome|1mg Baricitinib|1mg Baricitinib administered orally once daily.
11322776|NCT03334422|OG002|Outcome|2mg Baricitinib|2mg Baricitinib administered orally once daily.
11322777|NCT03334422|OG003|Outcome|4mg Baricitinib|4mg Baricitinib administered orally once daily.
11322778|NCT03334422|OG002|Outcome|2mg Bariciitnib|2mg Baricitinib administered orally once daily.
11322779|NCT03334422|OG000|Outcome|Placebo|Participants received placebo orally once daily for 16 weeks.
11322780|NCT03334422|EG000|Reported Event|Placebo|Placebo administered orally once daily.
11322781|NCT03334422|EG001|Reported Event|1mg Baricitinib|1 milligram (mg) Baricitinib administered orally once daily.
11322782|NCT03334422|EG002|Reported Event|2mg Baricitinib|2mg Baricitinib administered orally once daily.
11322783|NCT03334422|EG003|Reported Event|4mg Baricitinib|4mg Baricitinib administered orally once daily.
11322784|NCT03334448|BG000|Baseline|Overall|All randomized participants who received at least 1 dose of study drug
11322785|NCT03334448|FG000|Participant Flow|Sequence 1|"Single subcutaneous (SC) dose sequences with 3 day washout between doses:~A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-200 D. LY900014 U-100"
11322786|NCT03334448|FG001|Participant Flow|Sequence 2|"Single subcutaneous (SC) dose sequences with 3 day washout between doses:~A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-100 D. LY900014 U-200"
11322787|NCT03334448|FG002|Participant Flow|Sequence 3|"Single subcutaneous (SC) dose sequences with 3 day washout between doses:~A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-100 D. LY900014 U-200"
11322788|NCT03334448|FG003|Participant Flow|Sequence 4|"Single subcutaneous (SC) dose sequences with 3 day washout between doses:~A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-200 D. LY900014 U-100"
11322789|NCT03334448|OG000|Outcome|LY900014-U100|Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods
11322790|NCT03334448|OG001|Outcome|LY900014-U200|Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods
11322791|NCT03334448|EG000|Reported Event|LY900014-U100|Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods
11322792|NCT03334448|EG001|Reported Event|LY900014-U200|Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods
11322793|NCT03334630|BG000|Baseline|DiamondTemp Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter~DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322794|NCT03334630|BG001|Baseline|TactiCath Quartz Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter~TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322795|NCT03334630|BG002|Baseline|Total|Total of all reporting groups
11322796|NCT03334630|FG000|Participant Flow|DiamondTemp Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using the DiamondTemp temperature-controlled ablation catheter~DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322797|NCT03334630|FG001|Participant Flow|TactiCath Quartz Ablation Catheter|"Catheter ablation to treat atrial fibrillation using the TactiCath Quartz contact-force sensing ablation catheter~TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322798|NCT03334630|OG000|Outcome|DiamondTemp Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter~DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322799|NCT03334630|OG001|Outcome|TactiCath Quartz Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter~TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322800|NCT03334630|EG000|Reported Event|DiamondTemp Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter~DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322801|NCT03334630|EG001|Reported Event|TactiCath Quartz Ablation Catheter|"Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter~TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter"
11322802|NCT03334695|BG000|Baseline|Ad26.RSV.preF (1*10^11 vp)|Participants received a single intramuscular injection of 1*10^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322803|NCT03334695|BG001|Baseline|Placebo|Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322804|NCT03334695|BG002|Baseline|Total|Total of all reporting groups
11322805|NCT03334695|FG000|Participant Flow|Ad26.RSV.preF (1*10^11 vp)|Participants received a single intramuscular injection of 1*10^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322806|NCT03334695|FG001|Participant Flow|Placebo|Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322807|NCT03334695|OG000|Outcome|Ad26.RSV.preF (1*10^11 vp)|Participants received a single intramuscular injection of 1*10^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322808|NCT03334695|OG001|Outcome|Placebo|Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
11322809|NCT03334695|EG000|Reported Event|Post-dose: Ad26.RSV.preF (1x10^11 vp)|Participants received a single intramuscular injection of 1*10^11 vp (viral particles) of Ad26.RSV.preF on Day -28.
11322810|NCT03334695|EG001|Reported Event|Post-dose: Placebo|Participants received a single intramuscular injection of matching placebo on Day -28.
11322811|NCT03334695|EG002|Reported Event|Post-challenge: Challenge After Ad26.RSV.preF|Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28.
11322812|NCT03334695|EG003|Reported Event|Post-challenge: Challenge After Placebo|Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28.
11322813|NCT03334721|BG000|Baseline|Gabapentin, Then Placebo Oral Capsule|"Week 1: Gabapentin: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Week 2: Placebo: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7)."
11322814|NCT03334721|BG001|Baseline|Placebo Oral Capsule, Then Gabapentin|"Week 1: Placebo: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Week 2: Gabapentin: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7)."
11322815|NCT03334721|BG002|Baseline|Total|Total of all reporting groups
11322816|NCT03334721|FG000|Participant Flow|Gabapentin, Then Placebo Oral Capsule|"Week 1: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Week 2: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Gabapentin: 5 day trial of gabapentin with titration to 1,200mg~Placebo Oral Capsule: 5 day trial of matched placebo"
11322817|NCT03334721|FG001|Participant Flow|Placebo Oral Capsule, Then Gabapentin|"Week 1: 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Week 2: 1-week condition will consist of an in-person study visit for assessment and dispensing of Gabapentin medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Gabapentin: 5 day trial of gabapentin with titration to 1,200mg~Placebo Oral Capsule: 5 day trial of matched placebo"
11322818|NCT03334721|OG000|Outcome|Gabapentin|"Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Gabapentin: 5 day trial of gabapentin with titration to 1,200mg"
11322819|NCT03334721|OG001|Outcome|Placebo Oral Capsule|"Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Placebo Oral Capsule: 5 day trial of matched placebo"
11322820|NCT03334721|EG000|Reported Event|Gabapentin|"Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Gabapentin: 5 day trial of gabapentin with titration to 1,200mg"
11322821|NCT03334721|EG001|Reported Event|Placebo Oral Capsule|"Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).~Placebo Oral Capsule: 5 day trial of matched placebo"
11322822|NCT03334734|BG000|Baseline|PBTZ169, 160 mg|"2 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322823|NCT03334734|BG001|Baseline|PBTZ169, 320 mg|"4 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322824|NCT03334734|BG002|Baseline|PBTZ169, 640 mg|"8 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322825|NCT03334734|BG003|Baseline|Isoniazid, 600 mg|"2 tablets 300 mg of Isoniazid once a day for 14 days~Isoniazid: Once a day for 14 days"
11322826|NCT03334734|BG004|Baseline|Total|Total of all reporting groups
11322827|NCT03334734|FG000|Participant Flow|PBTZ169, 160 mg|"2 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322828|NCT03334734|FG001|Participant Flow|PBTZ169, 320 mg|"4 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322829|NCT03334734|FG002|Participant Flow|PBTZ169, 640 mg|"8 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322830|NCT03334734|FG003|Participant Flow|Isoniazid, 600 mg|"2 tablets 300 mg of Isoniazid once a day for 14 days~Isoniazid: Once a day for 14 days"
11322831|NCT03334734|OG000|Outcome|PBTZ169, 160 mg|"2 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322832|NCT03334734|OG001|Outcome|PBTZ169, 320 mg|"4 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322833|NCT03334734|OG002|Outcome|PBTZ169, 640 mg|"8 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322834|NCT03334734|OG003|Outcome|Isoniazid, 600 mg|"2 tablets 300 mg of Isoniazid once a day for 14 days~Isoniazid: Once a day for 14 days"
11322835|NCT03334734|EG000|Reported Event|PBTZ169, 160 mg|"2 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322836|NCT03334734|EG001|Reported Event|PBTZ169, 320 mg|"4 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322837|NCT03334734|EG002|Reported Event|PBTZ169, 640 mg|"8 capsules 80 mg of PBTZ169 once a day for 14 days~PBTZ169: Once a day for 14 days"
11322838|NCT03334734|EG003|Reported Event|Isoniazid, 600 mg|"2 tablets 300 mg of Isoniazid once a day for 14 days~Isoniazid: Once a day for 14 days"
11322839|NCT03334747|BG000|Baseline|KAE609 10 mg SD|KAE609 10 mg once daily (QD) for 1 day
11322840|NCT03334747|BG001|Baseline|KAE609 10 mg QD 3 Days|KAE609 10 mg (QD) for 3 days
11322841|NCT03334747|BG002|Baseline|KAE609 25 mg SD|KAE609 25 mg once daily (QD) for 1 day
11322842|NCT03334747|BG003|Baseline|KAE609 25 mg QD 3 Days|KAE609 25 mg once daily (QD) for 3 days
11322843|NCT03334747|BG004|Baseline|KAE609 50 mg SD|KAE609 50 mg once daily (QD) for 1 day
11322844|NCT03334747|BG005|Baseline|KAE609 50 mg QD 3 Days|KAE609 50 mg once daily (QD) for 3 days
11322845|NCT03334747|BG006|Baseline|KAE609 75 mg SD|KAE609 75 mg once daily (QD) for 1 day
11322846|NCT03334747|BG007|Baseline|KAE609 150 mg SD|KAE609 150 mg once daily (QD) for 1 day
11322847|NCT03334747|BG008|Baseline|Pooled Coartem Control|control arm
11322848|NCT03334747|BG009|Baseline|Total|Total of all reporting groups
11322849|NCT03334747|FG000|Participant Flow|KAE609 10 mg SD|KAE609 10 mg once daily (QD) for 1 day
11322850|NCT03334747|FG001|Participant Flow|KAE609 10 mg QD 3 Days|KAE609 10 mg (QD) for 3 days
11322851|NCT03334747|FG002|Participant Flow|KAE609 25 mg SD|KAE609 25 mg once daily (QD) for 1 day
11322852|NCT03334747|FG003|Participant Flow|KAE609 25 mg QD 3 Days|KAE609 25 mg once daily (QD) for 3 days
11322853|NCT03334747|FG004|Participant Flow|KAE609 50 mg SD|KAE609 50 mg once daily (QD) for 1 day
11322854|NCT03334747|FG005|Participant Flow|KAE609 50 mg QD 3 Days|KAE609 50 mg once daily (QD) for 3 days
11322855|NCT03334747|FG006|Participant Flow|KAE609 75 mg SD|KAE609 75 mg once daily (QD) for 1 day
11322856|NCT03334747|FG007|Participant Flow|KAE609 150 mg SD|KAE609 150 mg once daily (QD) for 1 day
11322857|NCT03334747|FG008|Participant Flow|Pooled Coartem Control|control arm
11322858|NCT03334747|OG000|Outcome|KAE609 10 mg SD|KAE609 10 mg once daily (QD) for 1 day
11322859|NCT03334747|OG001|Outcome|KAE609 10 mg QD 3 Days|KAE609 10 mg (QD) for 3 days
11322860|NCT03334747|OG002|Outcome|KAE609 25 mg SD|KAE609 25 mg once daily (QD) for 1 day
11322861|NCT03334747|OG003|Outcome|KAE609 25 mg QD 3 Days|KAE609 25 mg once daily (QD) for 3 days
11322862|NCT03334747|OG004|Outcome|KAE609 50 mg SD|KAE609 50 mg once daily (QD) for 1 day
11322863|NCT03334747|OG005|Outcome|KAE609 50 mg QD 3 Days|KAE609 50 mg once daily (QD) for 3 days
11322864|NCT03334747|OG006|Outcome|KAE609 75 mg SD|KAE609 75 mg once daily (QD) for 1 day
11322865|NCT03334747|OG007|Outcome|KAE609 150 mg SD|KAE609 150 mg once daily (QD) for 1 day
11322866|NCT03334747|OG008|Outcome|Pooled Coartem Control|control arm
11322867|NCT03334747|EG000|Reported Event|KAE609 10mg SD|KAE609 10mg SD
11322868|NCT03334747|EG001|Reported Event|KAE609 10mg QD@3 Days|KAE609 10mg QD@3 days
11322869|NCT03334747|EG002|Reported Event|KAE609 25mg SD|KAE609 25mg SD
11322870|NCT03334747|EG003|Reported Event|KAE609 25mg QD@3 Days|KAE609 25mg QD@3 days
11322871|NCT03334747|EG004|Reported Event|KAE609 50mg SD|KAE609 50mg SD
11322872|NCT03334747|EG005|Reported Event|KAE609 50mg QD@3 Days|KAE609 50mg QD@3 days
11322873|NCT03334747|EG006|Reported Event|KAE609 75mg SD|KAE609 75mg SD
11322874|NCT03334747|EG007|Reported Event|KAE609 150mg SD|KAE609 150mg SD
11322875|NCT03334747|EG008|Reported Event|Pooled Coartem|Pooled Coartem
11322876|NCT03334812|BG000|Baseline|LNA043 20mg|LNA043 20mg/3ml single dose
11322877|NCT03334812|BG001|Baseline|Matching Placebo to 20mg|Matching placebo to 20mg/3ml, single dose
11322878|NCT03334812|BG002|Baseline|Total|Total of all reporting groups
11322879|NCT03334812|FG000|Participant Flow|LNA043 20mg|LNA043 20mg/3ml single dose
11322880|NCT03334812|FG001|Participant Flow|Matching Placebo to 20mg|Matching placebo to 20mg/3ml, single dose
11322881|NCT03334812|FG002|Participant Flow|LNA043 40mg|LNA043 40mg/4ml single dose
11322882|NCT03334812|FG003|Participant Flow|Matching Placebo to 40mg|Matching placebo to 40mg/4ml, single dose
11322883|NCT03334812|OG000|Outcome|LNA043 20mg|LNA043 20mg/3ml single dose
11322884|NCT03334812|OG001|Outcome|Matching Placebo to 20mg|Matching placebo to 20mg/3ml, single dose
11322885|NCT03334812|EG000|Reported Event|LNA043 20mg|LNA043 20mg
11322886|NCT03334812|EG001|Reported Event|Placebo|Placebo
11322887|NCT03334825|BG000|Baseline|Enhanced Housing Placement Assistance|Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
11322888|NCT03334825|BG001|Baseline|Standard Housing Placement Assistance|Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
11322889|NCT03334825|BG002|Baseline|Total|Total of all reporting groups
11322890|NCT03334825|FG000|Participant Flow|Enhanced Housing Placement Assistance|Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
11322891|NCT03334825|FG001|Participant Flow|Standard Housing Placement Assistance|Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
11322892|NCT03334825|OG000|Outcome|Enhanced Housing Placement Assistance|Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
11322893|NCT03334825|OG001|Outcome|Standard Housing Placement Assistance|Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
11322894|NCT03334825|EG000|Reported Event|Enhanced Housing Placement Assistance|"assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability~Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability"
11322895|NCT03334825|EG001|Reported Event|Standard Housing Placement Assistance|"standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White~Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White"
11322896|NCT03334903|BG000|Baseline|Standard of Care|Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission.
11322897|NCT03334903|BG001|Baseline|Postoperative Gabapentin Regimen|"Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.~Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery."
11322898|NCT03334903|BG002|Baseline|Total|Total of all reporting groups
11322899|NCT03334903|FG000|Participant Flow|Standard of Care|Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission.
11322900|NCT03334903|FG001|Participant Flow|Postoperative Gabapentin Regimen|"Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.~Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery."
11322901|NCT03334903|OG000|Outcome|Standard of Care|Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission.
11322902|NCT03334903|OG001|Outcome|Postoperative Gabapentin Regimen|"Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.~Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery."
11322903|NCT03334903|EG000|Reported Event|Standard of Care|Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission.
11322904|NCT03334903|EG001|Reported Event|Postoperative Gabapentin Regimen|"Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.~Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery."
11322905|NCT03335150|BG000|Baseline|Supportive Care|"Support Group for PD~Supportive Care: Support Group for persons with PD"
11322906|NCT03335150|BG001|Baseline|CogSMART-PD|"Cognitive Rehabilitation for PD~CogSMART-PD: Cognitive Rehabilitation for persons with PD"
11322907|NCT03335150|BG002|Baseline|Total|Total of all reporting groups
11322908|NCT03335150|FG000|Participant Flow|Supportive Care|"Support Group for PD~Supportive Care: Support Group for persons with PD"
11322909|NCT03335150|FG001|Participant Flow|CogSMART-PD|"Cognitive Rehabilitation for PD~CogSMART-PD: Cognitive Rehabilitation for persons with PD"
11322910|NCT03335150|OG000|Outcome|Supportive Care|"Support Group for PD~Supportive Care: Support Group for persons with PD"
11322911|NCT03335150|OG001|Outcome|CogSMART-PD|"Cognitive Rehabilitation for PD~CogSMART-PD: Cognitive Rehabilitation for persons with PD"
11322912|NCT03335150|EG000|Reported Event|Supportive Care|"Support Group for PD~Supportive Care: Support Group for persons with PD"
11322913|NCT03335150|EG001|Reported Event|CogSMART-PD|"Cognitive Rehabilitation for PD~CogSMART-PD: Cognitive Rehabilitation for persons with PD"
11322914|NCT03335254|BG000|Baseline|Dose-Escalating Arm 1|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dos 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322915|NCT03335254|BG001|Baseline|Dose-Escalating Arm 2|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322916|NCT03335254|BG002|Baseline|Dose-Escalating Arm 3|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322917|NCT03335254|BG003|Baseline|Dose-Escalating Arm 4|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322918|NCT03335254|BG004|Baseline|Dose-Escalating Arm 5|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322919|NCT03335254|BG005|Baseline|Dose-Escalating Arm 6|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322920|NCT03335254|BG006|Baseline|Dose-Escalating Arm 7|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322921|NCT03335254|BG007|Baseline|Dose-Escalating Arm 8|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322922|NCT03335254|BG008|Baseline|Dose-Escalating Arm 9|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322923|NCT03335254|BG009|Baseline|Dose-Escalating Arm 10|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11335992|NCT03559257|FG001|Participant Flow|Galcanezumab 120mg|Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period.
11322924|NCT03335254|BG010|Baseline|Dose-Escalating Arm 11|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322925|NCT03335254|BG011|Baseline|Dose-Escalating Arm 12|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322926|NCT03335254|BG012|Baseline|Dose-Escalating Arm 13|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322927|NCT03335254|BG013|Baseline|Dose-Escalating Arm 14|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322928|NCT03335254|BG014|Baseline|Dose-Escalating Arm 15|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322929|NCT03335254|BG015|Baseline|Dose-Escalating Arm 16|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322930|NCT03335254|BG016|Baseline|Dose-Escalating Arm 17|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322931|NCT03335254|BG017|Baseline|Dose-Escalating Arm 18|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322932|NCT03335254|BG018|Baseline|Dose-Escalating Arm 19|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322933|NCT03335254|BG019|Baseline|Dose-Escalating Arm 20|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322934|NCT03335254|BG020|Baseline|Total|Total of all reporting groups
11335993|NCT03559257|OG000|Outcome|Placebo - Double-Blind Treatment Phase|Participants received matching placebo every month for three months by SC injection.
11322935|NCT03335254|FG000|Participant Flow|Dose-Escalating Arm 1|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322936|NCT03335254|FG001|Participant Flow|Dose-Escalating Arm 2|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322937|NCT03335254|FG002|Participant Flow|Dose-Escalating Arm 3|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322938|NCT03335254|FG003|Participant Flow|Dose-Escalating Arm 4|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322939|NCT03335254|FG004|Participant Flow|Dose-Escalating Arm 5|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322940|NCT03335254|FG005|Participant Flow|Dose-Escalating Arm 6|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322941|NCT03335254|FG006|Participant Flow|Dose-Escalating Arm 7|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322942|NCT03335254|FG007|Participant Flow|Dose-Escalating Arm 8|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322943|NCT03335254|FG008|Participant Flow|Dose-Escalating Arm 9|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322944|NCT03335254|FG009|Participant Flow|Dose-Escalating Arm 10|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11335994|NCT03559257|OG001|Outcome|Galcanezumab 120mg - Double-Blind Treatment Phase|Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.
11335995|NCT03559257|OG001|Outcome|Galcanezumab 120mg - Double-Blind Treatment Phase|Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
11322945|NCT03335254|FG010|Participant Flow|Dose-Escalating Arm 11|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322946|NCT03335254|FG011|Participant Flow|Dose-Escalating Arm 12|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322947|NCT03335254|FG012|Participant Flow|Dose-Escalating Arm 13|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322948|NCT03335254|FG013|Participant Flow|Dose-Escalating Arm 14|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322949|NCT03335254|FG014|Participant Flow|Dose-Escalating Arm 15|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322950|NCT03335254|FG015|Participant Flow|Dose-Escalating Arm 16|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322951|NCT03335254|FG016|Participant Flow|Dose-Escalating Arm 17|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322952|NCT03335254|FG017|Participant Flow|Dose-Escalating Arm 18|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322953|NCT03335254|FG018|Participant Flow|Dose-Escalating Arm 19|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11335996|NCT03559257|EG000|Reported Event|Placebo - Double-Blind Treatment Phase|Participants received matching placebo every month for three months by SC injection.
11335997|NCT03559257|EG001|Reported Event|Galcanezumab 120mg - Double-Blind Treatment Phase|Participants received initial loading dose of 240 milligrams (mg) of Galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.
11335998|NCT03559257|EG002|Reported Event|Placebo/Galcanezumab 120mg - Open-Label Treatment Phase|Participants received initial loading dose of 240mg Galcanezumab followed by 120mg every month for two months by SC injection.
11335999|NCT03559257|EG003|Reported Event|Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment|Participants received 120mg of Galcanezumab every month for three months by SC injection.
11322954|NCT03335254|FG019|Participant Flow|Dose-Escalating Arm 20|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322955|NCT03335254|OG000|Outcome|Dose-Escalating Arm 1|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322956|NCT03335254|OG001|Outcome|Dose-Escalating Arm 2|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322957|NCT03335254|OG002|Outcome|Dose-Escalating Arm 3|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322958|NCT03335254|OG003|Outcome|Dose-Escalating Arm 4|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322959|NCT03335254|OG004|Outcome|Dose-Escalating Arm 5|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322960|NCT03335254|OG005|Outcome|Dose-Escalating Arm 6|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322961|NCT03335254|OG006|Outcome|Dose-Escalating Arm 7|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322962|NCT03335254|OG007|Outcome|Dose-Escalating Arm 8|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322963|NCT03335254|OG008|Outcome|Dose-Escalating Arm 9|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11336000|NCT03559517|BG000|Baseline|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336001|NCT03559517|BG001|Baseline|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11322964|NCT03335254|OG009|Outcome|Dose-Escalating Arm 10|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322965|NCT03335254|OG010|Outcome|Dose-Escalating Arm 11|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322966|NCT03335254|OG011|Outcome|Dose-Escalating Arm 12|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322967|NCT03335254|OG012|Outcome|Dose-Escalating Arm 13|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322968|NCT03335254|OG013|Outcome|Dose-Escalating Arm 14|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322969|NCT03335254|OG014|Outcome|Dose-Escalating Arm 15|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322970|NCT03335254|OG015|Outcome|Dose-Escalating Arm 16|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.~Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322971|NCT03335254|OG016|Outcome|Dose-Escalating Arm 17|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322972|NCT03335254|OG017|Outcome|Dose-Escalating Arm 18|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11336002|NCT03559517|BG002|Baseline|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336003|NCT03559517|BG003|Baseline|Total|Total of all reporting groups
11336004|NCT03559517|FG000|Participant Flow|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336005|NCT03559517|FG001|Participant Flow|Ontamalimab 25 mg|Participants received ontamalimab 25 milligram (mg), injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11336006|NCT03559517|FG002|Participant Flow|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11322973|NCT03335254|OG018|Outcome|Dose-Escalating Arm 19|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322974|NCT03335254|OG019|Outcome|Dose-Escalating Arm 20|"Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.~Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322975|NCT03335254|EG000|Reported Event|Period 1: Single Dose|"Period 1. Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322976|NCT03335254|EG001|Reported Event|Period 2: Twice Daily Dose|"380 mg TSX-011 twice daily dosing period of 15 days in fed conditions.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322977|NCT03335254|EG002|Reported Event|Period 3, Day 16-25: Once Daily Dose|"If Period 2 Day 8 total testosterone is >800 ng/dL, subjects randomized in a 1:1 ratio to receive:~Schedule A: 317 mg (TU) TSX-011 twice daily OR~Schedule B: 507 mg (TU) TSX-011 once daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322978|NCT03335254|EG003|Reported Event|Period 3, Day 16-25: Twice Daily Dose|"If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.~If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.~If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.~If Period 2 Day 8 total testosterone is >800 ng/dL, randomize subjects in a 1:1 ratio to receive:~Schedule A: 317 mg (TU) TSX-011 twice daily OR~Schedule B: 507 mg (TU) TSX-011 once daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322979|NCT03335254|EG004|Reported Event|Period 3, Day 26-30: Once Daily Dose|"If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL:~Dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.~If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.~If Period 3, Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose as follows: Dose adjust subjects on once-daily dosing from 507 mg TU daily to 380 mg TU daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322980|NCT03335254|EG005|Reported Event|Period 3, Day 26-30: Twice Daily Dose|"If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL:~Dose adjust subjects on twice daily dosing as follows:~If dose is 570 mg TU twice daily, increase to 633 mg TU twice daily.~If dose is 443 mg TU twice daily, increase to 507 mg TU twice daily.~If dose is 380 mg TU twice daily, increase to 443 mg TU twice daily.~If dose is 317 mg TU twice daily, increase to 380 mg TU twice daily. If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose twice daily.~If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose as follows:~For the twice-daily dosing group:~If dose is 570 mg TU twice daily, decrease to 507 mg TU twice daily.~If dose is 443 mg TU twice daily, decrease to 380 mg TU twice daily.~If dose is 380 mg TU twice daily, decrease to 317 mg TU twice daily.~If dose is 317 mg TU twice daily, decrease to 253 mg TU twice daily. TSX-011 are capsules with primarily Testosterone Undecanoate."
11322981|NCT03335254|EG006|Reported Event|Period 3, Day 26-30: Thrice Daily Dose|"If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.~TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient."
11322982|NCT03335566|BG000|Baseline|Sonazoid™|Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.
11322983|NCT03335566|BG001|Baseline|SonoVue®|Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
11322984|NCT03335566|BG002|Baseline|Total|Total of all reporting groups
11322985|NCT03335566|FG000|Participant Flow|Sonazoid™|Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.
11322986|NCT03335566|FG001|Participant Flow|SonoVue®|Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
11322987|NCT03335566|OG000|Outcome|Sonazoid™|Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
11322988|NCT03335566|OG001|Outcome|SonoVue®|Participants received single I.V bolus injection of SonoVue® 2.4 mL.
11322989|NCT03335566|EG000|Reported Event|Sonazoid™|Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
11322990|NCT03335566|EG001|Reported Event|SonoVue®|Participants received single I.V bolus injection of SonoVue® 2.4 mL.
11322991|NCT03335761|BG000|Baseline|Amplitude Setting #1 = 50% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)~InterStim Therapy: Device Programming"
11322992|NCT03335761|BG001|Baseline|Amplitude Setting #2 = 80% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)~InterStim Therapy: Device Programming"
11322993|NCT03335761|BG002|Baseline|Amplitude Setting #3 = Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)~InterStim Therapy: Device Programming"
11322994|NCT03335761|BG003|Baseline|Total|Total of all reporting groups
11322995|NCT03335761|FG000|Participant Flow|Amplitude Setting #1 = 50% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)~InterStim Therapy: Device Programming"
11322996|NCT03335761|FG001|Participant Flow|Amplitude Setting #2 = 80% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)~InterStim Therapy: Device Programming"
11322997|NCT03335761|FG002|Participant Flow|Amplitude Setting #3 = Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)~InterStim Therapy: Device Programming"
11322998|NCT03335761|OG000|Outcome|Amplitude Setting #1 = 50% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)~InterStim Therapy: Device Programming"
11322999|NCT03335761|OG001|Outcome|Amplitude Setting #2 = 80% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)~InterStim Therapy: Device Programming"
11323000|NCT03335761|OG002|Outcome|Amplitude Setting #3 = Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)~InterStim Therapy: Device Programming"
11323001|NCT03335761|EG000|Reported Event|Amplitude Setting #1 = 50% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)~InterStim Therapy: Device Programming"
11323002|NCT03335761|EG001|Reported Event|Amplitude Setting #2 = 80% Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)~InterStim Therapy: Device Programming"
11323003|NCT03335761|EG002|Reported Event|Amplitude Setting #3 = Sensory Threshold|"InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)~InterStim Therapy: Device Programming"
11323004|NCT03335800|BG000|Baseline|Apple Heart Study (AHS) App Users|Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
11323005|NCT03335800|FG000|Participant Flow|Apple Heart Study (AHS) App Users|Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
11323006|NCT03335800|OG000|Outcome|Apple Heart Study (AHS) App Users|Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
11323007|NCT03335800|EG000|Reported Event|Apple Heart Study (AHS) App Users|Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
11323008|NCT03336450|BG000|Baseline|SHP615|Participants received single fixed age-specific dose (6 months to less than [<] 1 year received 2.5 milligrams [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS)/SHP615 buccally by caregivers on Day 1.
11323009|NCT03336450|FG000|Participant Flow|SHP615|Participants received single fixed age-specific dose (6 months to less than [<] 1 year received 2.5 milligrams [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS)/SHP615 buccally by caregivers on Day 1.
11323010|NCT03336450|OG000|Outcome|SHP615|Participants received single fixed age-specific dose (6 months to less than [<] 1 year received 2.5 milligrams [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS)/SHP615 buccally by caregivers on Day 1.
11323011|NCT03336450|EG000|Reported Event|SHP615|Participants received single fixed age-specific dose (6 months to less than [<] 1 year received 2.5 milligrams [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS)/SHP615 buccally by caregivers on Day 1.
11323012|NCT03336502|BG000|Baseline|Serial PK (Subgroup 1)|Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements
11323013|NCT03336502|BG001|Baseline|Sparse PK (Subgroup 2)|POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements
11323014|NCT03336502|BG002|Baseline|Total|Total of all reporting groups
11323015|NCT03336502|FG000|Participant Flow|Serial PK (Subgroup 1)|Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements
11323016|NCT03336502|FG001|Participant Flow|Sparse PK (Subgroup 2)|POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements
11323017|NCT03336502|OG000|Outcome|Serial PK (Subgroup 1)|Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements
11323018|NCT03336502|OG001|Outcome|Sparse PK (Subgroup 2)|POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements
11323019|NCT03336502|OG000|Outcome|POS IV (MK-5592)|POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days.
11323020|NCT03336502|EG000|Reported Event|POS IV (MK-5592)|POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days
11323021|NCT03336645|BG000|Baseline|SHP615|Participants received single fixed age-specific dose (3 months to less than [<] 1 year received 2.4 milligram [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
11323022|NCT03336645|FG000|Participant Flow|SHP615|Participants received single fixed age-specific dose (3 months to less than [<] 1 year received 2.4 milligram [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
11323023|NCT03336645|OG000|Outcome|SHP615|Participants received single fixed age-specific dose (3 months to less than [<] 1 year received 2.4 milligram [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
11323024|NCT03336645|EG000|Reported Event|SHP615|Participants received single fixed age-specific dose (3 months to less than [<] 1 year received 2.4 milligram [mg]; 1 to < 5 years received 5 mg; 5 to <10 years received 7.5 mg and 10 to < 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
11323025|NCT03336853|BG000|Baseline|HybenX ®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HybenX: The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.~A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323026|NCT03336853|BG001|Baseline|Control|"5 cc of sterile saline water for 20 sec~Placebo control: The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323027|NCT03336853|BG002|Baseline|Total|Total of all reporting groups
11323028|NCT03336853|FG000|Participant Flow|HybenX ®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HybenX: The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.~A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323029|NCT03336853|FG001|Participant Flow|Control|"5 cc of sterile saline water for 20 sec~Placebo control: The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323030|NCT03336853|OG000|Outcome|HybenX ®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HybenX: The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.~A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323031|NCT03336853|OG001|Outcome|Control|"5 cc of sterile saline water for 20 sec~Placebo control: The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323032|NCT03336853|EG000|Reported Event|HybenX ®|"1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec~HybenX: The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.~A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323033|NCT03336853|EG001|Reported Event|Control|"5 cc of sterile saline water for 20 sec~Placebo control: The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
11323034|NCT03337139|BG000|Baseline|Lifestyle Modification|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices."
11323035|NCT03337139|BG001|Baseline|Lifestyle Modification + Share|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices."
11323036|NCT03337139|BG002|Baseline|Total|Total of all reporting groups
11323037|NCT03337139|FG000|Participant Flow|Lifestyle Modification|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices."
11323038|NCT03337139|FG001|Participant Flow|Lifestyle Modification + Share|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices."
11323039|NCT03337139|OG000|Outcome|Lifestyle Modification|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices."
11323040|NCT03337139|OG001|Outcome|Lifestyle Modification + Share|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices."
11333912|NCT03521141|BG001|Baseline|Nicotine Metabolite Ratio (PC-NMR)|"Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11336007|NCT03559517|OG000|Outcome|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323041|NCT03337139|EG000|Reported Event|Lifestyle Modification|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices."
11323042|NCT03337139|EG001|Reported Event|Lifestyle Modification + Share|"Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.~Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.~Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices."
11323043|NCT03337152|BG000|Baseline|1A: Primaquine|primaquine: Participants receive primaquine for 14 days at 0.5 mg/Kg.
11323044|NCT03337152|BG001|Baseline|1B: Chloroquine + Primaquine|chloroquine + primaquine: Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg.
11323045|NCT03337152|BG002|Baseline|Total|Total of all reporting groups
11323046|NCT03337152|FG000|Participant Flow|1A: Primaquine|primaquine: Participants receive primaquine for 14 days at 0.5 mg/Kg.
11323047|NCT03337152|FG001|Participant Flow|1B: Chloroquine + Primaquine|chloroquine + primaquine: Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg.
11323048|NCT03337152|OG000|Outcome|1A: Primaquine|primaquine: Participants receive primaquine for 14 days at 0.5 mg/Kg.
11323049|NCT03337152|OG001|Outcome|1B: Chloroquine + Primaquine|chloroquine + primaquine: Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg.
11323050|NCT03337152|OG000|Outcome|1A: Primaquine|Primaquine: Participants receive primaquine for 14 days at 0.5 mg/Kg.
11323051|NCT03337152|OG001|Outcome|1B: Chloroquine + Primaquine|Chloroquine + primaquine: Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg.
11323052|NCT03337152|EG000|Reported Event|1A: Primaquine|primaquine: Participants receive primaquine for 14 days at 0.5 mg/Kg.
11323053|NCT03337152|EG001|Reported Event|1B: Chloroquine + Primaquine|chloroquine + primaquine: Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg.
11323054|NCT03337308|BG000|Baseline|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11323055|NCT03337308|BG001|Baseline|Bempedoic Acid 180 mg|Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.
11323056|NCT03337308|BG002|Baseline|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11323057|NCT03337308|BG003|Baseline|Placebo|Participants received placebo to match the bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.
11323058|NCT03337308|BG004|Baseline|Total|Total of all reporting groups
11323059|NCT03337308|FG000|Participant Flow|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11323060|NCT03337308|FG001|Participant Flow|Bempedoic Acid 180 mg|Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.
11323061|NCT03337308|FG002|Participant Flow|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11323062|NCT03337308|FG003|Participant Flow|Placebo|Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.
11323063|NCT03337308|OG000|Outcome|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11323064|NCT03337308|OG001|Outcome|Bempedoic Acid 180 mg|Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.
11323065|NCT03337308|OG002|Outcome|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11323066|NCT03337308|OG003|Outcome|Placebo|Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.
11323067|NCT03337308|EG000|Reported Event|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11323068|NCT03337308|EG001|Reported Event|Bempedoic Acid 180 mg|Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.
11323069|NCT03337308|EG002|Reported Event|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11323070|NCT03337308|EG003|Reported Event|Placebo|Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.
11323071|NCT03337477|BG000|Baseline|Sodium Zirconium Cyclosilicate (SZC) 10g|SZC will be administered in addition to insulin and glucose.
11323072|NCT03337477|BG001|Baseline|Placebo|Placebo will be administered in addition to insulin and glucose.
11323073|NCT03337477|BG002|Baseline|Total|Total of all reporting groups
11323074|NCT03337477|FG000|Participant Flow|Sodium Zirconium Cyclosilicate (SZC) 10g|SZC will be administered in addition to insulin and glucose.
11323075|NCT03337477|FG001|Participant Flow|Placebo|Placebo will be administered in addition to insulin and glucose.
11323076|NCT03337477|OG000|Outcome|Sodium Zirconium Cyclosilicate (SZC) 10g|SZC will be administered in addition to insulin and glucose.
11323077|NCT03337477|OG001|Outcome|Placebo|Placebo will be administered in addition to insulin and glucose.
11323078|NCT03337477|EG000|Reported Event|Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h)|SZC will be administered in addition to insulin and glucose. AEs collected between 0-24h.
11323079|NCT03337477|EG001|Reported Event|Placebo (0-24h)|Placebo will be administered in addition to insulin and glucose. AEs collected between 0-24h.
11323080|NCT03337477|EG002|Reported Event|Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h)|SZC will be administered in addition to insulin and glucose. AEs collected after 24h.
11323081|NCT03337477|EG003|Reported Event|Placebo (After 24 h)|Placebo will be administered in addition to insulin and glucose. AEs collected after 24h.
11323082|NCT03337490|BG000|Baseline|Ivermectin 0.5% Lotion|"Ivermectin 0.5% lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline."
11323083|NCT03337490|BG001|Baseline|Ivermectin 0.5% Lotion [SKLICE]|"Sklice 0.5% Lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion [SKLICE]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline."
11323084|NCT03337490|BG002|Baseline|Placebo 0% Lotion|"0% lotion, 117g, single dose~Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline."
11323085|NCT03337490|BG003|Baseline|Total|Total of all reporting groups
11323086|NCT03337490|FG000|Participant Flow|Ivermectin 0.5% Lotion|"Ivermectin 0.5% lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline."
11323087|NCT03337490|FG001|Participant Flow|Ivermectin 0.5% Lotion [SKLICE]|"Sklice 0.5% Lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion [SKLICE]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline."
11323088|NCT03337490|FG002|Participant Flow|Placebo 0% Lotion|"0% lotion, 117g, single dose~Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline."
11323089|NCT03337490|OG000|Outcome|Ivermectin 0.5% Lotion|"Ivermectin 0.5% lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline."
11323090|NCT03337490|OG001|Outcome|Ivermectin 0.5% Lotion [SKLICE]|"Sklice 0.5% Lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion [SKLICE]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline."
11323091|NCT03337490|OG002|Outcome|Placebo 0% Lotion|"0% lotion, 117g, single dose~Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline."
11323092|NCT03337490|EG000|Reported Event|Ivermectin 0.5% Lotion|"Ivermectin 0.5% lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline."
11323093|NCT03337490|EG001|Reported Event|Ivermectin 0.5% Lotion [SKLICE]|"Sklice 0.5% Lotion, topical, 117g, single dose~Ivermectin 0.5% Topical Application Lotion [SKLICE]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline."
11323094|NCT03337490|EG002|Reported Event|Placebo 0% Lotion|"0% lotion, 117g, single dose~Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline."
11323095|NCT03337542|BG000|Baseline|AR101|"Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.~AR101: AR101 powder provided in sachets"
11323096|NCT03337542|FG000|Participant Flow|AR101|"Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.~AR101: AR101 powder provided in sachets"
11323097|NCT03337542|OG000|Outcome|AR101|"Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.~AR101: AR101 powder provided in sachets"
11323098|NCT03337542|OG000|Outcome|AR101|"Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance~AR101: AR101 powder provided in sachets"
11323099|NCT03337542|EG000|Reported Event|Treatment Arm Description|"Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.~AR101: AR101 powder provided in sachets"
11323100|NCT03338010|BG000|Baseline|LY2963016|Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
11323101|NCT03338010|BG001|Baseline|Lantus®|Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
11323102|NCT03338010|BG002|Baseline|Total|Total of all reporting groups
11336008|NCT03559517|OG001|Outcome|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323103|NCT03338010|FG000|Participant Flow|LY2963016|Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤ 100 milligram per deciliter (mg/dL) (5.6 millimoles per litre [mmol/L]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).
11323104|NCT03338010|FG001|Participant Flow|Lantus®|Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
11323105|NCT03338010|OG000|Outcome|LY2963016|Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
11323106|NCT03338010|OG001|Outcome|Lantus®|Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
11323107|NCT03338010|EG000|Reported Event|LY2963016|Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
11323108|NCT03338010|EG001|Reported Event|Lantus®|Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
11323109|NCT03338023|BG000|Baseline|LY2963016 + Insulin Lispro|Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323110|NCT03338023|BG001|Baseline|Lantus® + Insulin Lispro|Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323111|NCT03338023|BG002|Baseline|Total|Total of all reporting groups
11323112|NCT03338023|FG000|Participant Flow|LY2963016 + Insulin Lispro|Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323113|NCT03338023|FG001|Participant Flow|Lantus® + Insulin Lispro|Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323114|NCT03338023|OG000|Outcome|LY2963016 + Insulin Lispro|Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323115|NCT03338023|OG001|Outcome|Lantus® + Insulin Lispro|Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323116|NCT03338023|EG000|Reported Event|LY2963016 + Insulin Lispro|Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323117|NCT03338023|EG001|Reported Event|Lantus® + Insulin Lispro|Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
11323118|NCT03338036|BG000|Baseline|Heart Rate Variability Biofeedback|"Participants in this arm of the study will only receive HRV biofeedback. This constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes. Participants in this arm will meet with the co-investigator bi-weekly to review progress and express feedback.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes."
11323119|NCT03338036|BG001|Baseline|Heart Rate Variability/Neurofeedback|"Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.~Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator."
11323120|NCT03338036|BG002|Baseline|Post-Concussed Control Group|Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
11323121|NCT03338036|BG003|Baseline|Non-Concussed Control Group|Age-matched individuals who have not been diagnosed with a concussion in the previous two years
11323122|NCT03338036|BG004|Baseline|Total|Total of all reporting groups
11323123|NCT03338036|FG000|Participant Flow|Heart Rate Variability Biofeedback|"Participants in this arm of the study will only receive HRV biofeedback. This constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes. Participants in this arm will meet with the co-investigator bi-weekly to review progress and express feedback.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes."
11336009|NCT03559517|OG002|Outcome|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323124|NCT03338036|FG001|Participant Flow|Heart Rate Variability/Neurofeedback|"Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.~Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator."
11323125|NCT03338036|FG002|Participant Flow|Post-Concussed Control Group|Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
11323126|NCT03338036|FG003|Participant Flow|Non-Concussed Control Group|Age-matched individuals who have not been diagnosed with a concussion in the previous two years
11323127|NCT03338036|OG000|Outcome|Heart Rate Variability/Neurofeedback|"Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.~Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator."
11323128|NCT03338036|OG001|Outcome|Post-Concussed Control Group|Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
11323129|NCT03338036|OG002|Outcome|Non-Concussed Control Group|Age-matched individuals who have not been diagnosed with a concussion in the previous two years
11323130|NCT03338036|EG000|Reported Event|Heart Rate Variability/Neurofeedback|"Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.~Heart Rate Variability Biofeedback: HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.~Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator."
11323131|NCT03338036|EG001|Reported Event|Post-Concussed Control Group|Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
11323132|NCT03338036|EG002|Reported Event|Non-Concussed Control Group|Age-matched individuals who have not been diagnosed with a concussion in the previous two years
11323133|NCT03338062|BG000|Baseline|Theragnostic SBRT Planning|The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323134|NCT03338062|BG001|Baseline|Standard SBRT Planning|The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323135|NCT03338062|BG002|Baseline|Total|Total of all reporting groups
11323136|NCT03338062|FG000|Participant Flow|Theragnostic SBRT Planning|The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323137|NCT03338062|FG001|Participant Flow|Standard SBRT Planning|The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323138|NCT03338062|OG000|Outcome|Theragnostic SBRT Planning|The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323139|NCT03338062|OG001|Outcome|Standard SBRT Planning|The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323140|NCT03338062|OG000|Outcome|Overall|All patients who were enrolled on study, received RT, and were assessed for the primary objective.
11323141|NCT03338062|EG000|Reported Event|Theragnostic SBRT Planning|The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323142|NCT03338062|EG001|Reported Event|Standard SBRT Planning|The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
11323143|NCT03338296|BG000|Baseline|Placebo|Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.
11323144|NCT03338296|BG001|Baseline|Lorcaserin 20 mg|Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
11323145|NCT03338296|BG002|Baseline|Total|Total of all reporting groups
11323146|NCT03338296|FG000|Participant Flow|Placebo|Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.
11323147|NCT03338296|FG001|Participant Flow|Lorcaserin 20 mg|Participants received one lorcaserin 20 milligram (mg) tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
11323148|NCT03338296|OG000|Outcome|Placebo|Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.
11323149|NCT03338296|OG001|Outcome|Lorcaserin 20 mg|Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
11323150|NCT03338296|EG000|Reported Event|Placebo|Participants received one lorcaserin matching-placebo tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin matched placebo.
11323151|NCT03338296|EG001|Reported Event|Lorcaserin 20 mg|Participants received one lorcaserin 20 mg tablet, orally, once daily up to 52 weeks. Participants were followed for 4 weeks after last dose of lorcaserin.
11323152|NCT03338400|BG000|Baseline|Dexamethasone|"Patients in the Dexamethasone arm will be administered the drug at the time of induction.~Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction."
11323153|NCT03338400|BG001|Baseline|Normal Saline|"The placebo arm patients will receive normal saline at the time of induction.~Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction."
11323154|NCT03338400|BG002|Baseline|Total|Total of all reporting groups
11323155|NCT03338400|FG000|Participant Flow|Dexamethasone|"Patients in the Dexamethasone arm will be administered the drug at the time of induction.~Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction."
11323156|NCT03338400|FG001|Participant Flow|Normal Saline|"The placebo arm patients will receive normal saline at the time of induction.~Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction."
11323157|NCT03338400|OG000|Outcome|Dexamethasone|"Patients in the Dexamethasone arm will be administered the drug at the time of induction.~Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction."
11323158|NCT03338400|OG001|Outcome|Normal Saline|"The placebo arm patients will receive normal saline at the time of induction.~Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction."
11323159|NCT03338400|OG000|Outcome|Normal Saline|Postoperative nausea scale
11323160|NCT03338400|OG001|Outcome|Dexamethasone|Postoperative nausea scale
11323161|NCT03338400|OG000|Outcome|Normal Saline|Number of UTIs
11323162|NCT03338400|OG001|Outcome|Dexamethasone|Number of UTIs
11323163|NCT03338400|OG000|Outcome|Normal Saline|ER visits post-op
11323164|NCT03338400|OG001|Outcome|Dexamethasone|ER visits post-op
11323165|NCT03338400|OG000|Outcome|Normal Saline|Postoperative pain scale
11323166|NCT03338400|OG001|Outcome|Dexamethasone|Postoperative pain scale
11323167|NCT03338400|EG000|Reported Event|Dexamethasone|"Patients in the Dexamethasone arm will be administered the drug at the time of induction.~Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction."
11323168|NCT03338400|EG001|Reported Event|Normal Saline|"The placebo arm patients will receive normal saline at the time of induction.~Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction."
11323169|NCT03338556|BG000|Baseline|Cohort A - PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323170|NCT03338556|BG001|Baseline|Cohort A - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323171|NCT03338556|BG002|Baseline|Cohort B- PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323172|NCT03338556|BG003|Baseline|Cohort B - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323173|NCT03338556|BG004|Baseline|Total|Total of all reporting groups
11323174|NCT03338556|FG000|Participant Flow|Cohort A - PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323175|NCT03338556|FG001|Participant Flow|Cohort A - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323176|NCT03338556|FG002|Participant Flow|Cohort B- PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323177|NCT03338556|FG003|Participant Flow|Cohort B - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323178|NCT03338556|OG000|Outcome|Cohort A - PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323179|NCT03338556|OG001|Outcome|Cohort A - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323180|NCT03338556|OG002|Outcome|Cohort B- PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323181|NCT03338556|OG003|Outcome|Cohort B - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323182|NCT03338556|EG000|Reported Event|Cohort A - PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323183|NCT03338556|EG001|Reported Event|Cohort A - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323184|NCT03338556|EG002|Reported Event|Cohort B- PrEP-001|"PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~PrEP-001"
11323185|NCT03338556|EG003|Reported Event|Cohort B - Placebo|"Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).~Placebo"
11323186|NCT03338569|BG000|Baseline|Placebo|"Placebo designed to mimic intervention~Placebo: Placebo designed to mimic intervention"
11323187|NCT03338569|BG001|Baseline|Intervention|"Vitamin C~Vitamin C: Continuous infusion of vitamin C"
11323188|NCT03338569|BG002|Baseline|Total|Total of all reporting groups
11323189|NCT03338569|FG000|Participant Flow|Placebo|"Placebo designed to mimic intervention~Placebo: Placebo designed to mimic intervention"
11323190|NCT03338569|FG001|Participant Flow|Intervention|"Vitamin C~Vitamin C: Continuous infusion of vitamin C"
11323191|NCT03338569|OG000|Outcome|Placebo|"Placebo designed to mimic intervention~Placebo: Placebo designed to mimic intervention"
11323192|NCT03338569|OG001|Outcome|Intervention|"Vitamin C~Vitamin C: Continuous infusion of vitamin C"
11323193|NCT03338569|EG000|Reported Event|Placebo|"Placebo designed to mimic intervention~Placebo: Placebo designed to mimic intervention"
11323194|NCT03338569|EG001|Reported Event|Intervention|"Vitamin C~Vitamin C: Continuous infusion of vitamin C"
11323195|NCT03338673|BG000|Baseline|Dual Therapy First|"Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323196|NCT03338673|BG001|Baseline|Mono Therapy First|"Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323197|NCT03338673|BG002|Baseline|Total|Total of all reporting groups
11323198|NCT03338673|FG000|Participant Flow|Dual Therapy First|"Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323199|NCT03338673|FG001|Participant Flow|Mono Therapy First|"Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323200|NCT03338673|OG000|Outcome|Dual Therapy First|"Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323201|NCT03338673|OG001|Outcome|Mono Therapy First|"Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323202|NCT03338673|EG000|Reported Event|Dual Therapy First|"Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323203|NCT03338673|EG001|Reported Event|Mono Therapy First|"Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises~tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function~BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory"
11323204|NCT03338686|BG000|Baseline|Free Gingival Graft|"Free Gingival Graft (FGG)~Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm."
11323205|NCT03338686|BG001|Baseline|Connective Tissue Graft Followed by Laser Gingivoplasty|"Connective Tissue Graft (CTG) followed by Laser Gingivoplasty~Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm."
11323206|NCT03338686|BG002|Baseline|FGG + CTG|Both FGG and CTG (at different implants in the same patient)
11323207|NCT03338686|BG003|Baseline|Total|Total of all reporting groups
11323208|NCT03338686|FG000|Participant Flow|Free Gingival Graft|"Free Gingival Graft (FGG)~Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm."
11323209|NCT03338686|FG001|Participant Flow|Connective Tissue Graft Followed by Laser Gingivoplasty|"Connective Tissue Graft (CTG) followed by Laser Gingivoplasty~Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm."
11323210|NCT03338686|FG002|Participant Flow|FGG + CTG|Both FGG and CTG (at different implants in the same patient)
11323211|NCT03338686|OG000|Outcome|Free Gingival Graft|"Free Gingival Graft (FGG)~Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm."
11323212|NCT03338686|OG001|Outcome|Connective Tissue Graft Followed by Laser Gingivoplasty|"Connective Tissue Graft (CTG) followed by Laser Gingivoplasty~Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm."
11323213|NCT03338686|EG000|Reported Event|Free Gingival Graft|"Free Gingival Graft (FGG)~Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm."
11323214|NCT03338686|EG001|Reported Event|Connective Tissue Graft Followed by Laser Gingivoplasty|"Connective Tissue Graft (CTG) followed by Laser Gingivoplasty~Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm."
11323215|NCT03338686|EG002|Reported Event|FGG + CTG|Both FGG and CTG (at different implants in the same patient)
11323216|NCT03338803|BG000|Baseline|Patients With Written Prescription for Initiating Linagliptin|Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
11323217|NCT03338803|FG000|Participant Flow|Patients With Written Prescription for Initiating Linagliptin|Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
11323218|NCT03338803|OG000|Outcome|Patients With Written Prescription for Initiating Linagliptin|Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
11323219|NCT03338803|EG000|Reported Event|Patients With Written Prescription for Initiating Linagliptin|Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
11323220|NCT03338855|BG000|Baseline|Dapagliflozin 10 mg Then Placebo|Patients received an oral dose of 10 mg dapagliflozin, once daily for 5 weeks. After a wash-out period of 6 to 8 weeks, matched placebo tablets were taken orally, once daily for 5 weeks.
11323221|NCT03338855|BG001|Baseline|Placebo Then Dapagliflozin 10 mg|Patients received placebo tablets (matched to dapagliflozin) taken orally, once daily for 5 weeks. After a wash-out period of 6 to 8 weeks, patients received an oral dose of 10 mg dapagliflozin, once daily for 5 weeks.
11323222|NCT03338855|BG002|Baseline|Total|Total of all reporting groups
11323223|NCT03338855|FG000|Participant Flow|Dapagliflozin 10 mg Then Placebo|Patients received an oral dose of 10 milligrams (mg) dapagliflozin, once daily for 5 weeks. After a wash-out period of 6 to 8 weeks, matched placebo tablets were taken orally, once daily for 5 weeks.
11323224|NCT03338855|FG001|Participant Flow|Placebo Then Dapagliflozin 10 mg|Patients received placebo tablets (matched to dapagliflozin) taken orally, once daily for 5 weeks. After a wash-out period of 6 to 8 weeks, patients received an oral dose of 10 mg dapagliflozin, once daily for 5 weeks.
11323225|NCT03338855|OG000|Outcome|Dapagliflozin 10 mg|Patients received an oral dose of 10 mg dapagliflozin, once daily for 5 weeks in either Treatment Period 1 or Treatment Period 2.
11323226|NCT03338855|OG001|Outcome|Placebo|Patients received an oral dose of placebo, once daily for 5 weeks in either Treatment Period 1 or Treatment Period 2.
11323227|NCT03338855|EG000|Reported Event|Dapagliflozin 10mg|Patients received an oral dose of 10mg dapagliflozin, once daily for 5 weeks in either Treatment Period 1 or Treatment Period 2.
11323228|NCT03338855|EG001|Reported Event|Placebo|Patients received an oral dose of placebo, once daily for 5 weeks in either Treatment Period 1 or Treatment Period 2.
11323229|NCT03338894|BG000|Baseline|Yoga Group|"Each subject will serve as their own control~Yoga: 1 Hour yoga class"
11323230|NCT03338894|FG000|Participant Flow|Yoga Group|"Each subject will serve as their own control~Yoga: 1 Hour yoga class"
11323231|NCT03338894|OG000|Outcome|Yoga Group|"Each subject will serve as their own control~Yoga: 1 Hour yoga class"
11323232|NCT03338894|EG000|Reported Event|Yoga Group|"Each subject will serve as their own control~Yoga: 1 Hour yoga class"
11323233|NCT03338998|BG000|Baseline|BAF312|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
11323234|NCT03338998|BG001|Baseline|Placebo|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
11323235|NCT03338998|BG002|Baseline|Total|Total of all reporting groups
11323236|NCT03338998|FG000|Participant Flow|BAF312|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
11323237|NCT03338998|FG001|Participant Flow|Placebo|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
11323238|NCT03338998|OG000|Outcome|BAF312|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
11323239|NCT03338998|OG001|Outcome|Placebo|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
11323240|NCT03338998|EG000|Reported Event|BAF312|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
11323241|NCT03338998|EG001|Reported Event|Placebo|Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
11323242|NCT03338998|EG002|Reported Event|Total|Total
11323243|NCT03339206|BG000|Baseline|Constituent Message With FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message with FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be r"
11323244|NCT03339206|BG001|Baseline|Constituent Message Without FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message without FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times"
11336010|NCT03559517|EG000|Reported Event|Placebo|Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323245|NCT03339206|BG002|Baseline|Littering Message (Control)|"Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.~Littering message (Control): Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team."
11323246|NCT03339206|BG003|Baseline|Total|Total of all reporting groups
11323247|NCT03339206|FG000|Participant Flow|Constituent Message With FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message with FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be r"
11323248|NCT03339206|FG001|Participant Flow|Constituent Message Without FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message without FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times"
11323249|NCT03339206|FG002|Participant Flow|Littering Message (Control)|"Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.~Littering message (Control): Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team."
11323250|NCT03339206|OG000|Outcome|Constituent Message With FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message with FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be r"
11323251|NCT03339206|OG001|Outcome|Constituent Message Without FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message without FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times"
11323252|NCT03339206|OG002|Outcome|Littering Message (Control)|"Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.~Littering message (Control): Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team."
11323253|NCT03339206|EG000|Reported Event|Constituent Message With FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message with FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be r"
11336011|NCT03559517|EG001|Reported Event|Ontamalimab 25 mg|Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323254|NCT03339206|EG001|Reported Event|Constituent Message Without FDA and Quitline|"Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.~Constituent message without FDA and quitline: Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times"
11323255|NCT03339206|EG002|Reported Event|Littering Message (Control)|"Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.~Littering message (Control): Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team."
11323256|NCT03339219|BG000|Baseline|Cabozantinib 60 mg|Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.
11323257|NCT03339219|FG000|Participant Flow|Cabozantinib 60 mg|Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.
11323258|NCT03339219|OG000|Outcome|Cabozantinib 60 mg|Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.
11323259|NCT03339219|EG000|Reported Event|Cabozantinib 60 mg|Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.
11323260|NCT03339297|BG000|Baseline|Defibrotide Prophylaxis|Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.
11323261|NCT03339297|BG001|Baseline|Standard of Care Immunoprophylaxis|Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
11323262|NCT03339297|BG002|Baseline|Total|Total of all reporting groups
11323263|NCT03339297|FG000|Participant Flow|Defibrotide Prophylaxis|Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.
11323264|NCT03339297|FG001|Participant Flow|Standard of Care Immunoprophylaxis|Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
11323265|NCT03339297|OG000|Outcome|Defibrotide Prophylaxis|Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.
11323266|NCT03339297|OG001|Outcome|Standard of Care Immunoprophylaxis|Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
11323267|NCT03339297|OG001|Outcome|Standard of Care Immunoprohylaxis|Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
11323268|NCT03339297|OG001|Outcome|Standard of Care Immunoprophylaxis|Participants were administered Standard of Care immunoprophylaxis alone in a 1:1 ratio according to local institutional guidelines, physician preference, and patient need.
11323269|NCT03339297|EG000|Reported Event|Defibrotide Prophylaxis|Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.
11323270|NCT03339297|EG001|Reported Event|Standard of Care Immunoprophylaxis|Participants were administered Standard of Care immunoprophylaxis alone in a 1:1 ratio according to local institutional guidelines, physician preference, and patient need.
11323271|NCT03339453|BG000|Baseline|Glucagon|All enrolled participants who received either 3 mg NG or 1 mg IM Glucagon.
11323272|NCT03339453|FG000|Participant Flow|NG 1st/IM Glucagon 2nd|Participants received 3 mg of NG at the first treatment visit followed by 1 mg of IM glucagon at the second treatment visit.
11323273|NCT03339453|FG001|Participant Flow|IM Glucagon 1st/NG 2nd|Participants received 1 mg of IM glucagon at the first treatment visit followed by 3 mg of NG at the second treatment visit.
11323274|NCT03339453|OG000|Outcome|Nasal Glucagon (NG)|Dose of 3 mg nasal glucagon.
11323275|NCT03339453|OG001|Outcome|IM Glucagon|Dose of 1 mg IM glucagon.
11323276|NCT03339453|EG000|Reported Event|Nasal Glucagon (NG)|Dose of 3 mg nasal glucagon.
11323277|NCT03339453|EG001|Reported Event|Intramuscular (IM) Glucagon|Dose of 1 mg intramuscular glucagon.
11323278|NCT03339570|BG000|Baseline|Orthopedic Treatment|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323279|NCT03339570|FG000|Participant Flow|Orthopedic Treatment|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323280|NCT03339570|OG000|Outcome|Orthopedic Treatment: Constant Scale Evaluation at 3 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323281|NCT03339570|OG001|Outcome|Orthopedic Treatment: Constant Scale Evaluation at 12 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323282|NCT03339570|OG000|Outcome|Orthopedic Treatment: ASES Scale Evaluation at 3 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323283|NCT03339570|OG001|Outcome|Orthopedic Treatment: ASES Scale Evaluation at 12 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323284|NCT03339570|OG000|Outcome|Orthopedic Treatment: DASH Scale Evaluation at 3 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323285|NCT03339570|OG001|Outcome|Orthopedic Treatment: DASH Scale Evaluation at 12 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323286|NCT03339570|OG000|Outcome|Orthopedic Treatment:VAS Scale Evaluation at 3 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323287|NCT03339570|OG001|Outcome|Orthopedic Treatment:VAS Scale Evaluation at 12 Months|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323288|NCT03339570|OG000|Outcome|Surgical Cohort: Constant Scale Evaluation at 12 Months|The historical cohort consists of 20 patients who underwent surgery for this same pathology in our hospital, and who received a reverse total shoulder arthroplasty.
11336012|NCT03559517|EG002|Reported Event|Ontamalimab 75 mg|Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
11323289|NCT03339570|OG000|Outcome|Orthopedic Treatment|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323290|NCT03339570|EG000|Reported Event|Orthopedic Treatment|"This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.~Orthopedic treatment for a proximal humeral fracture: Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy."
11323291|NCT03339583|BG000|Baseline|Zopiclone First Group|"underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy~Brief behavioral therapy: program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off.~Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks"
11323292|NCT03339583|BG001|Baseline|BBT-I First Group|"received two-week brief behavioral therapy followed by medication therapy (zopiclone).~Brief behavioral therapy: program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off.~Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks"
11323293|NCT03339583|BG002|Baseline|Total|Total of all reporting groups
11323294|NCT03339583|FG000|Participant Flow|Zopiclone First, Then BBT-I|Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks
11323295|NCT03339583|FG001|Participant Flow|BBT-I First, Then Zopiclone|Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
11323296|NCT03339583|OG000|Outcome|BBT-I First Group|"received two-week brief behavioral therapy followed by medication therapy (zopiclone).~Brief behavioral therapy: program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off.~Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks"
11323297|NCT03339583|OG001|Outcome|Zopiclone First Group|"underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy~Brief behavioral therapy: program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off.~Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks"
11323298|NCT03339583|OG000|Outcome|Zopiclone First, Then BBT-I|Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks
11323299|NCT03339583|OG001|Outcome|BBT-I First, Then Zopiclone|Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
11323300|NCT03339583|EG000|Reported Event|BBT-I|"Brief behavioral therapy: program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off."
11323301|NCT03339583|EG001|Reported Event|Zopiclone|Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
11336013|NCT03559530|BG000|Baseline|Patients|All patients with bone tissue culture positive for Acinetobacter baumannii submitted to surgical procedures to treat osteomyelitis
11323302|NCT03339713|BG000|Baseline|Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo|Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
11323303|NCT03339713|BG001|Baseline|Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)|Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.
11323304|NCT03339713|BG002|Baseline|Total|Total of all reporting groups
11323305|NCT03339713|FG000|Participant Flow|Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo|Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
11323306|NCT03339713|FG001|Participant Flow|Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)|Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.
11323307|NCT03339713|OG000|Outcome|Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo|Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
11323308|NCT03339713|OG001|Outcome|Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)|Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.
11323309|NCT03339713|EG000|Reported Event|Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)|Participants received a single dose of intramuscular injection of 1*10^11 vp (viral particles) of Ad26.RSV.preF on Day 1 along with Fluarix administered at the same time.
11323310|NCT03339713|EG001|Reported Event|Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)|Participants received a single dose of intramuscular injection of matching placebo on Day 1 along with Fluarix administered at the same time.
11323311|NCT03339713|EG002|Reported Event|Group 1 Post-Dose 2: Placebo (Day 29)|Participants received a single dose of intramuscular injection of matching placebo on Day 29.
11323312|NCT03339713|EG003|Reported Event|Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)|Participants received a single dose of intramuscular injection of Ad26.RSV.preF on Day 29.
11323313|NCT03339726|BG000|Baseline|Placebo|One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
11323314|NCT03339726|BG001|Baseline|PE-IR|One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
11323315|NCT03339726|BG002|Baseline|PE-ER|One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
11323316|NCT03339726|BG003|Baseline|Total|Total of all reporting groups
11323317|NCT03339726|FG000|Participant Flow|Placebo|One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
11323318|NCT03339726|FG001|Participant Flow|PE-IR|One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
11323319|NCT03339726|FG002|Participant Flow|PE-ER|One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
11323320|NCT03339726|OG000|Outcome|Placebo|One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
11323321|NCT03339726|OG001|Outcome|PE-IR|One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
11323322|NCT03339726|OG002|Outcome|PE-ER|One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
11323323|NCT03339726|EG000|Reported Event|Placebo|One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
11323324|NCT03339726|EG001|Reported Event|PE-IR|One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
11323325|NCT03339726|EG002|Reported Event|PE-ER|One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
11323326|NCT03339999|BG000|Baseline|Placebo|Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323327|NCT03339999|BG001|Baseline|AGN-242428 Higher Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323328|NCT03339999|BG002|Baseline|AGN-242428 Medium Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323329|NCT03339999|BG003|Baseline|AGN-242428 Lower Dose|AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
11323330|NCT03339999|BG004|Baseline|Total|Total of all reporting groups
11323331|NCT03339999|FG000|Participant Flow|Placebo|Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323332|NCT03339999|FG001|Participant Flow|AGN-242428 Higher Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323333|NCT03339999|FG002|Participant Flow|AGN-242428 Medium Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323334|NCT03339999|FG003|Participant Flow|AGN-242428 Lower Dose|AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
11323335|NCT03339999|OG000|Outcome|Placebo|Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323336|NCT03339999|OG001|Outcome|AGN-242428 Higher Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323337|NCT03339999|OG002|Outcome|AGN-242428 Medium Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323338|NCT03339999|OG003|Outcome|AGN-242428 Lower Dose|AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
11323339|NCT03339999|OG000|Outcome|AGN-242428 Higher Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323340|NCT03339999|OG001|Outcome|AGN-242428 Medium Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323341|NCT03339999|OG002|Outcome|AGN-242428 Lower Dose|AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
11323342|NCT03339999|EG000|Reported Event|Placebo|Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323343|NCT03339999|EG001|Reported Event|AGN-242428 Higher Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323344|NCT03339999|EG002|Reported Event|AGN-242428 Medium Dose|AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
11323345|NCT03339999|EG003|Reported Event|AGN-242428 Lower Dose|AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
11323346|NCT03340025|BG000|Baseline|Negative Pressure Wound Therapy|"PICO Single Use Negative Pressure Wound Therapy System~PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump"
11323347|NCT03340025|BG001|Baseline|Conventional Dressing|"traditional surgical wound dressing of xeroform gauze and padding~xeroform gauze: traditional surgical dressing of xeroform gauze and padding"
11323348|NCT03340025|BG002|Baseline|Total|Total of all reporting groups
11323349|NCT03340025|FG000|Participant Flow|Negative Pressure Wound Therapy|"PICO Single Use Negative Pressure Wound Therapy System~PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump"
11323350|NCT03340025|FG001|Participant Flow|Conventional Dressing|"traditional surgical wound dressing of xeroform gauze and padding~xeroform gauze: traditional surgical dressing of xeroform gauze and padding"
11323351|NCT03340025|OG000|Outcome|Negative Pressure Wound Therapy|"PICO Single Use Negative Pressure Wound Therapy System~PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump"
11323352|NCT03340025|OG001|Outcome|Conventional Dressing|"traditional surgical wound dressing of xeroform gauze and padding~xeroform gauze: traditional surgical dressing of xeroform gauze and padding"
11323353|NCT03340025|EG000|Reported Event|Negative Pressure Wound Therapy|"PICO Single Use Negative Pressure Wound Therapy System~PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump"
11323354|NCT03340025|EG001|Reported Event|Conventional Dressing|"traditional surgical wound dressing of xeroform gauze and padding~xeroform gauze: traditional surgical dressing of xeroform gauze and padding"
11323355|NCT03340337|BG000|Baseline|All Participants|"Maximal Voluntary Isometric Contraction (MVIC) will be measured for data normalization.~Then, the subjects will receive 3 types of electrical stimulation (Neo-Russian, Aussie and RBS), in a randomized order. The Maximal Elicited Induced Contraction (MEIC) will be measured.~An isometric dynamometer will be used for acquiring MVIC and MEIC. The protocol will be 3 reps x 5 sec work x 120 sec rest and the best rep will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.~One week later, the subjects will receive a fatigue protocol with the three types of electrical stimulation applied in the randomized order that consists in 21 reps (5 sec work x 5 sec rest). The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep."
11323356|NCT03340337|FG000|Participant Flow|All Participants|"Measurement of MVIC.~All the participants received 3 types of electrical stimulation (Neo-Russian, Aussie and RBS), in a randomized order (balanced permutations, forming 5 x 6 blocks for the three currents).~Determination of Maximal Electrical Induced Contraction (MEIC).~Dosing information:~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 120 sec Reps: 3, whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.~Current parameters:~Neo-Russian: Waveform: Rectangular biphasic symmetrical / Carrier frequency: 2500 Hz / Modulation frequency: 50 Hz / Pulse width: 400 us / Duty cycle: 50 %.~Aussie: Waveform: Sinousoidal / Carrier frequency: 1000 Hz / Modulation frequency: 50 Hz / Pulse width: 1000 us / Duty cycle: 20 %.~RBS: Waveform: Rectangular biphasic symmetrical / Frequency: 50 Hz / Pulse width: 400 us.~Washout: 1 week~Fatigue test: All the participants received 3 types of electrical stimulation (Neo-Russian, Aussie and RBS), in a randomized order.~Dosing information:~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 5 sec Reps: 21. Current parameters: Same as previous."
11323357|NCT03340337|OG000|Outcome|All Study Participants.|"As the MVIC was used to normalize the data for others outcome measures, all study participants were included into one arm.~A short 10-minute walk was taken to warm-up. The patient was positioned in a therapeutic chair with the hip at 110°, stabilizing the trunk (at chest level) and the hip (at the level of the anterior superior iliac spines) with straps. Knee was placed in 90° flexion. A goniometer was used to correctly position the joints at said angles.~The patient was instructed to cross his arms over his chest and relax. The subject was blindfolded to prevent him from watching the procedure.~The measuring system was attached to the distal end of the right lower limb by means of an ankle brace.~The subject was instructed to perform a maximum voluntary isometric contraction.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Work time: 3 sec~Rest time: 120 sec~Reps: 3 (Whenever the third one was the best, additional measurements were asked by the software until a decrease in torque was obtained to determine the maximum)."
11336014|NCT03559530|FG000|Participant Flow|Carbapenem Susceptible A. Baumannii|106 patients with osteomyelitis related to carbapenem-susceptible A. baumannii
11336015|NCT03559530|FG001|Participant Flow|XDR Acinetobacter Baumannii|For this analysis, the 65 patients with XDR A. baumannii -related osteomyelitis, always resistant to carbapenems, treated with colistin or tigecycline were included.
11336016|NCT03559530|OG000|Outcome|Patients|Patients with A. baumannii-related osteomyelitis
11336017|NCT03559530|OG000|Outcome|Susceptibility Profile of A. Baumannii Isolates Over Time|Variation in the susceptibility of A. baumannii isolates to antimicrobials over time from 2007 to 2015.
11323358|NCT03340337|OG000|Outcome|Neo-Russian Electrical Stimulation|"After measuring the MVIC, subject rested for 120 seconds (while searching for motor points for rectus femoris and vastus medialis).~All subjects received all currents in a randomized order. The subject was asked not to make any voluntary contraction. Neo-Russian electrical stimulation was applied. At the higher tolerated intensity, the MEIC was measured and normalized with the MVIC.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 120 sec Reps: 3, whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.~Current parameters:~Neo-Russian: Waveform: Rectangular biphasic symmetrical / Carrier frequency: 2500 Hz / Modulation frequency: 50 Hz / Pulse width: 400 us / Duty cycle: 50 %.~An interval of 120 seconds was also taken between the determinations of the MEIC with each current, in order to minimize fatigue."
11323359|NCT03340337|OG001|Outcome|Aussie Electrical Stimulation|"After measuring the MVIC, subject rested for 120 seconds (while searching for motor points for rectus femoris and vastus medialis).~All subjects received all currents in a randomized order. The subject was asked not to make any voluntary contraction. Aussie electrical stimulation was applied. At the higher tolerated intensity, the MEIC was measured and normalized with the MVIC.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 120 sec Reps: 3, whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.~Current parameters:~Aussie: Waveform: Sinousoidal / Carrier frequency: 1000 Hz / Modulation frequency: 50 Hz / Pulse width: 1000 us / Duty cycle: 20 %.~An interval of 120 seconds was also taken between the determinations of the MEIC with each current, in order to minimize fatigue."
11323360|NCT03340337|OG002|Outcome|RBS Electrical Stimulation|"After measuring the MVIC, subject rested for 120 seconds (while searching for motor points for rectus femoris and vastus medialis).~All subjects received all currents in a randomized order. The subject was asked not to make any voluntary contraction. RBS electrical stimulation was applied. At the higher tolerated intensity, the MEIC was measured and normalized with the MVIC.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 120 sec Reps: 3, whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.~Current parameters:~RBS: Waveform: Rectangular biphasic symmetrical / Frequency: 50 Hz / Pulse width: 400 us.~An interval of 120 seconds was also taken between the determinations of the MEIC with each current, in order to minimize fatigue."
11323361|NCT03340337|OG000|Outcome|Neo-Russian Electrical Stimulation|"After recording the MEIC of Neo-Russian electrical stimulation, the subject was given a VAS and was asked to indicate how unpleasant he found the electro-stimulation with this current, with 0 (on the left) being no pain and 10 (on the right) the equivalent of crying in pain."
11323362|NCT03340337|OG001|Outcome|Aussie Electrical Stimulation|"After recording the MEIC of Aussie electrical stimulation, the subject was given a VAS and was asked to indicate how unpleasant he found the electro-stimulation with this current, with 0 (on the left) being no pain and 10 (on the right) the equivalent of crying in pain."
11323363|NCT03340337|OG002|Outcome|RBS Electrical Stimulation|"After recording the MEIC of RBS electrical stimulation, the subject was given a VAS and was asked to indicate how unpleasant he found the electro-stimulation with this current, with 0 (on the left) being no pain and 10 (on the right) the equivalent of crying in pain."
11323364|NCT03340337|OG000|Outcome|Neo-Russian Electrical Stimulation|"Fatigue induced by the electrical stimulation was measured in a randomized order after one week of washout period.~An isometric dynamometer was used. The patient was instructed to cross his arms over his chest, to relax and not to make any voluntary contraction. The subject was blindfolded to prevent him from watching the procedure. The measuring system was attached to the distal end of the right lower limb.~The intensity was increased until it reached the maximum tolerable by the subject. Data was taken from the MEIC of 21 contractions.~Each repetition was normalized as a percentage of MVIC. Then, Repetition 1 was considered to be 100 %. Subsequently, it was calculated what percentage of repetition 1 the subsequent repetitions corresponded to. The number of repetitions equal to or lower than 50% was then counted, thus determining the fatigue induced by each type of electrical stimulation.~An interval of 120 seconds was also taken between the determinations of the Fatigue test with each current.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 5 sec Reps: 21 Neo-Russian: Waveform: Rectangular biphasic symmetrical / Carrier frequency: 2500 Hz / Modulation frequency: 50 Hz / Pulse width: 400 us / Duty cycle: 50 %."
11323365|NCT03340337|OG001|Outcome|Aussie Electrical Stimulation|"Fatigue induced by the electrical stimulation was measured in a randomized order after one week of washout period.~An isometric dynamometer was used. The patient was instructed to cross his arms over his chest, to relax and not to make any voluntary contraction. The subject was blindfolded to prevent him from watching the procedure. The measuring system was attached to the distal end of the right lower limb.~The intensity was increased until it reached the maximum tolerable by the subject. Data was taken from the MEIC of 21 contractions.~Each repetition was normalized as a percentage of MVIC. Then, Repetition 1 was considered to be 100 %. Subsequently, it was calculated what percentage of repetition 1 the subsequent repetitions corresponded to. The number of repetitions equal to or lower than 50% was then counted, thus determining the fatigue induced by each type of electrical stimulation.~An interval of 120 seconds was also taken between the determinations of the Fatigue test with each current.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 5 sec Reps: 21 Aussie: Waveform: Sinousoidal / Carrier frequency: 1000 Hz / Modulation frequency: 50 Hz / Pulse width: 1000 us / Duty cycle: 20 %."
11336018|NCT03559530|EG000|Reported Event|XDR A. Baumannii|Patients with microbiologically proven XDR A. baumannii-related osteomyelitis who received colistin or tigecycline for treatment
11336019|NCT03559829|BG000|Baseline|Single Arm - Intervention Arm|RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
11336020|NCT03559829|FG000|Participant Flow|Single Arm - Intervention Arm|RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
11336021|NCT03559829|OG000|Outcome|Single Arm - Intervention Arm|RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
11323366|NCT03340337|OG002|Outcome|RBS Electrical Stimulation|"Fatigue induced by the electrical stimulation was measured in a randomized order after one week of washout period.~An isometric dynamometer was used. The patient was instructed to cross his arms over his chest, to relax and not to make any voluntary contraction. The subject was blindfolded to prevent him from watching the procedure. The measuring system was attached to the distal end of the right lower limb.~The intensity was increased until it reached the maximum tolerable by the subject. Data was taken from the MEIC of 21 contractions.~Each repetition was normalized as a percentage of MVIC. Then, Repetition 1 was considered to be 100 %. Subsequently, it was calculated what percentage of repetition 1 the subsequent repetitions corresponded to. The number of repetitions equal to or lower than 50% was then counted, thus determining the fatigue induced by each type of electrical stimulation.~An interval of 120 seconds was also taken between the determinations of the Fatigue test with each current.~Dosing information:~Knee angle: 90°~Hip angle: 110°~Contraction parameters:~Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 5 sec Reps: 21 RBS: Waveform: Rectangular biphasic symmetrical / Frequency: 50 Hz / Pulse width: 400 us."
11323367|NCT03340337|EG000|Reported Event|Neo-Russian Electrical Stimulation|"MVIC was measured for data normalization.~Subjects received Neo-Russian electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured.~They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).~One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction."
11323368|NCT03340337|EG001|Reported Event|Aussie Electrical Stimulation|"MVIC was measured for data normalization.~Subjects received Aussie electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured.~They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).~One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction."
11323369|NCT03340337|EG002|Reported Event|RBS Electrical Stimulation|"MVIC was measured for data normalization.~Subjects received RBS electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured.~They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).~One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction."
11323370|NCT03340350|BG000|Baseline|Minocycline|"Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12~Minocycline: Minocycline capsule"
11323371|NCT03340350|FG000|Participant Flow|Minocycline|"Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12~Minocycline: Minocycline capsule"
11323372|NCT03340350|OG000|Outcome|Minocycline|"Participants received minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12~Minocycline: Minocycline capsule"
11323373|NCT03340350|OG000|Outcome|Minocycline|"Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12~Minocycline: Minocycline capsule"
11323374|NCT03340350|EG000|Reported Event|Minocycline|"Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12~Minocycline: Minocycline capsule"
11323375|NCT03340415|BG000|Baseline|Control Rehab|Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
11323376|NCT03340415|BG001|Baseline|Accelerated Rehab|"Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation~Accelerated Rehabilitation plan: early weight bearing after surgery"
11323377|NCT03340415|BG002|Baseline|Total|Total of all reporting groups
11323378|NCT03340415|FG000|Participant Flow|Control Rehab|Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
11323379|NCT03340415|FG001|Participant Flow|Accelerated Rehab|"Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation~Accelerated Rehabilitation plan: early weight bearing after surgery"
11323380|NCT03340415|OG000|Outcome|Control Rehab|Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
11323381|NCT03340415|OG001|Outcome|Accelerated Rehab|"Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation~Accelerated Rehabilitation plan: early weight bearing after surgery"
11323382|NCT03340415|OG000|Outcome|Control 6-wk NWB|Control group ( 6 week NWB )
11323383|NCT03340415|OG001|Outcome|Early 2 Week NWB|Early weight bearing group （2 week)
11323384|NCT03340415|EG000|Reported Event|Control Rehab|Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
11323385|NCT03340415|EG001|Reported Event|Accelerated Rehab|"Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation~Accelerated Rehabilitation plan: early weight bearing after surgery"
11336022|NCT03559829|EG000|Reported Event|Single Arm - Intervention Arm|RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
11336023|NCT03559933|BG000|Baseline|Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy|Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
11323386|NCT03340428|BG000|Baseline|Transition Community Adherence Club (TCAC)|"Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.~Transition Community Adherence Club (TCAC): A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available."
11323387|NCT03340428|BG001|Baseline|Care as Usual (CAU)|Care as usual participants will be referred to routine clinic HIV care on release from corrections.
11323388|NCT03340428|BG002|Baseline|Total|Total of all reporting groups
11323389|NCT03340428|FG000|Participant Flow|Transition Community Adherence Club (TCAC)|"Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.~Transition Community Adherence Club (TCAC): A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available."
11323390|NCT03340428|FG001|Participant Flow|Care as Usual (CAU)|Care as usual participants will be referred to routine clinic HIV care on release from corrections.
11323391|NCT03340428|OG000|Outcome|Transition Community Adherence Club (TCAC)|"Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.~Transition Community Adherence Club (TCAC): A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available."
11323392|NCT03340428|OG001|Outcome|Care as Usual (CAU)|Care as usual participants will be referred to routine clinic HIV care on release from corrections.
11323393|NCT03340428|EG000|Reported Event|Transition Community Adherence Club (TCAC)|"Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.~Transition Community Adherence Club (TCAC): A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available."
11323394|NCT03340428|EG001|Reported Event|Care as Usual (CAU)|Care as usual participants will be referred to routine clinic HIV care on release from corrections.
11323395|NCT03340610|BG000|Baseline|Open Label Single Arm Trial|"Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab~Alflibercept: Intravitreal Injection"
11323396|NCT03340610|FG000|Participant Flow|Phase 4 Prospective, Nonrandomized, Open Label, Interventional|"Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab~Alflibercept: Intravitreal Injection~Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks."
11323397|NCT03340610|OG000|Outcome|Open Label Single Arm Trial|"Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab~Alflibercept: Intravitreal Injection"
11323398|NCT03340610|EG000|Reported Event|Phase 4 Prospective, Nonrandomized, Open Label, Interventional|"Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab~Alflibercept: Intravitreal Injection~Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks."
11323399|NCT03340805|BG000|Baseline|Lactated Ringer's Fluid (LR)|"Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Lactated Ringer: LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
11323400|NCT03340805|BG001|Baseline|"0.9% Normal Saline Fluid (NS)"|"0.9% normal saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Normal saline: Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
11323401|NCT03340805|BG002|Baseline|Total|Total of all reporting groups
11323402|NCT03340805|FG000|Participant Flow|Lactated Ringer's Fluid (LR)|"Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Lactated Ringer: LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
11323403|NCT03340805|FG001|Participant Flow|"0.9% Normal Saline Fluid (NS)"|"0.9% normal saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Normal saline: Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
11323404|NCT03340805|OG000|Outcome|Lactated Ringer's Fluid (LR)|"Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Lactated Ringer: LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
11323405|NCT03340805|OG001|Outcome|"0.9% Normal Saline Fluid (NS)"|"0.9% normal saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Normal saline: Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
11323406|NCT03340805|OG000|Outcome|All Eligible Patients|All patients age >6 mos to <18 years with clinician suspicion of septic shock who did not meet exclusion criteria
11323407|NCT03340805|OG000|Outcome|Subjects Enrolled Under Exception From Informed Consent|"Eligible subjects enrolled under exception from informed consent process"
11323408|NCT03340805|EG000|Reported Event|Lactated Ringer's Fluid (LR)|"Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Lactated Ringer: LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
11323409|NCT03340805|EG001|Reported Event|"0.9% Normal Saline Fluid (NS)"|"0.9% normal saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.~Normal saline: Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
11323410|NCT03340883|BG000|Baseline|Phase 1 BION-1301|"BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.~BION-1301: a solution for intravenous (IV) administration, diluted and administered Q2W"
11323411|NCT03340883|FG000|Participant Flow|BION-1301 50 mg Q2W|50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
11323412|NCT03340883|FG001|Participant Flow|BION-1301 150 mg Q2W|150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323413|NCT03340883|FG002|Participant Flow|BION-1301 450 mg Q2W|450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323414|NCT03340883|FG003|Participant Flow|BION-1301 1350 mg Q2W|1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323415|NCT03340883|FG004|Participant Flow|BION-1301 2700 mg Q2W|2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323416|NCT03340883|FG005|Participant Flow|BION-1301 1350 mg QW*8W->Q2W|1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
11323417|NCT03340883|OG000|Outcome|BION-1301 50 mg Q2W|50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
11323418|NCT03340883|OG001|Outcome|BION-1301 150 mg Q2W|150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323419|NCT03340883|OG002|Outcome|BION-1301 450 mg Q2W|450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323420|NCT03340883|OG003|Outcome|BION-1301 1350 mg Q2W|1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323421|NCT03340883|OG004|Outcome|BION-1301 2700 mg Q2W|2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323422|NCT03340883|OG005|Outcome|BION-1301 1350 mg QW*8W->Q2W|1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
11323423|NCT03340883|EG000|Reported Event|BION-1301 50 mg Q2W|50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
11323424|NCT03340883|EG001|Reported Event|BION-1301 150 mg Q2W|150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323425|NCT03340883|EG002|Reported Event|BION-1301 450 mg Q2W|450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323426|NCT03340883|EG003|Reported Event|BION-1301 1350 mg Q2W|1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323427|NCT03340883|EG004|Reported Event|BION-1301 2700 mg Q2W|2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
11323428|NCT03340883|EG005|Reported Event|BION-1301 1350 mg QW*8W->Q2W|1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
11323429|NCT03340961|BG000|Baseline|DFD-29 Extended Release Capsules (40 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (40 mg): Oral Treatment"
11323430|NCT03340961|BG001|Baseline|DFD-29 Extended Release Capsules (20 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (20 mg): Oral Treatment"
11323431|NCT03340961|BG002|Baseline|Oraycea® (Doxycycline) Capsules|"Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.~Oraycea® (doxycycline) Capsules: Oral Treatment"
11323432|NCT03340961|BG003|Baseline|Placebo Capsules|"Placebo Capsules once per day for 16 weeks.~Placebo Capsules: Oral Treatment"
11323433|NCT03340961|BG004|Baseline|Total|Total of all reporting groups
11323434|NCT03340961|FG000|Participant Flow|DFD-29 Extended Release Capsules (40 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (40 mg): Oral Treatment"
11323435|NCT03340961|FG001|Participant Flow|DFD-29 Extended Release Capsules (20 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (20 mg): Oral Treatment"
11323436|NCT03340961|FG002|Participant Flow|Oraycea® (Doxycycline) Capsules|"Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.~Oraycea® (doxycycline) Capsules: Oral Treatment"
11323437|NCT03340961|FG003|Participant Flow|Placebo Capsules|"Placebo Capsules once per day for 16 weeks.~Placebo Capsules: Oral Treatment"
11323438|NCT03340961|OG000|Outcome|DFD-29 Extended Release Capsules (40 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (40 mg): Oral Treatment"
11323439|NCT03340961|OG001|Outcome|DFD-29 Extended Release Capsules (20 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (20 mg): Oral Treatment"
11323440|NCT03340961|OG002|Outcome|Oraycea® (Doxycycline) Capsules|"Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.~Oraycea® (doxycycline) Capsules: Oral Treatment"
11323441|NCT03340961|OG003|Outcome|Placebo Capsules|"Placebo Capsules once per day for 16 weeks.~Placebo Capsules: Oral Treatment"
11323442|NCT03340961|EG000|Reported Event|DFD-29 Extended Release Capsules (40 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (40 mg): Oral Treatment"
11323443|NCT03340961|EG001|Reported Event|DFD-29 Extended Release Capsules (20 mg)|"DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.~DFD-29 Extended Release Capsules (20 mg): Oral Treatment"
11323444|NCT03340961|EG002|Reported Event|Oraycea® (Doxycycline) Capsules|"Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.~Oraycea® (doxycycline) Capsules: Oral Treatment"
11323445|NCT03340961|EG003|Reported Event|Placebo Capsules|"Placebo Capsules once per day for 16 weeks.~Placebo Capsules: Oral Treatment"
11323446|NCT03341273|BG000|Baseline|Azithromycin|500 mg of Azithromycin (2 capsules of 250 mg) administered orally as a single dose on Day 1, followed by 250 mg capsule of Azithromycin administered orally once daily for 4 days (Day 2 through Day 5).
11323447|NCT03341273|BG001|Baseline|Placebo|2 capsules of Azithromycin placebo administered orally as a single dose on Day 1, followed by 1 capsule of Azithromycin placebo administered orally once daily for 4 days (Day 2 through Day 5).
11323448|NCT03341273|BG002|Baseline|Total|Total of all reporting groups
11323449|NCT03341273|FG000|Participant Flow|Azithromycin|"500 mg of Azithromycin (2 capsules of 250 mg) administered orally as a single dose on Day 1, followed by 250 mg capsule of Azithromycin administered orally once daily for 4 days (Day 2 through Day 5).~Azithromycin: Azithromycin is an azalide antibiotic and is derived from erythromycin used to treat many different types of infections caused by bacteria, such as respiratory infections.~VIDAS B.R.A.H.M.S Procalcitonin Test (PCT): The VIDAS B.R.A.H.M.S PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma using the Enzyme-Linked Fluorescent Assay (ELFA) technique."
11323450|NCT03341273|FG001|Participant Flow|Placebo|"2 capsules of Azithromycin placebo administered orally as a single dose on Day 1, followed by 1 capsule of Azithromycin placebo administered orally once daily for 4 days (Day 2 through Day 5).~Placebo: Placebo will be a matching capsule the same size, weight, and color as the capsules containing Azithromycin tablets.~VIDAS B.R.A.H.M.S Procalcitonin Test (PCT): The VIDAS B.R.A.H.M.S PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma using the Enzyme-Linked Fluorescent Assay (ELFA) technique."
11323451|NCT03341273|OG000|Outcome|Azithromycin|500 mg of Azithromycin (2 capsules of 250 mg) administered orally as a single dose on Day 1, followed by 250 mg capsule of Azithromycin administered orally once daily for 4 days (Day 2 through Day 5).
11323452|NCT03341273|OG001|Outcome|Placebo|2 capsules of Azithromycin placebo administered orally as a single dose on Day 1, followed by 1 capsule of Azithromycin placebo administered orally once daily for 4 days (Day 2 through Day 5).
11323453|NCT03341273|EG000|Reported Event|Azithromycin|500 mg of Azithromycin (2 capsules of 250 mg) administered orally as a single dose on Day 1, followed by 250 mg capsule of Azithromycin administered orally once daily for 4 days (Day 2 through Day 5).
11323454|NCT03341273|EG001|Reported Event|Placebo|2 capsules of Azithromycin placebo administered orally as a single dose on Day 1, followed by 1 capsule of Azithromycin placebo administered orally once daily for 4 days (Day 2 through Day 5).
11323455|NCT03341299|BG000|Baseline|Overall Study|All randomized participants who received at least 1 dose of study drug.
11323456|NCT03341299|FG000|Participant Flow|Cohort 1|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 3:LY900014 administered SC 20 minutes after start of meal Period 4: insulin lispro administered SC immediately before meal"
11323457|NCT03341299|FG001|Participant Flow|Cohort 2|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1:LY900014 administered SC 20 minutes after start of meal Period 2: LY900014 administered subcutaneously (SC) immediately before meal Period 3: insulin lispro (Humalog) administered SC immediately before meal Period 4: insulin lispro (Humalog) administered SC 20 minutes after start of meal"
11323458|NCT03341299|FG002|Participant Flow|Cohort 3|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: insulin lispro (Humalog) administered SC immediately before meal Period 2:LY900014 administered SC 20 minutes after start of meal Period 3: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 4: LY900014 administered subcutaneously (SC) immediately before meal"
11323459|NCT03341299|FG003|Participant Flow|Cohort 4|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 2: insulin lispro (Humalog) administered SC immediately before meal Period 3: LY900014 administered subcutaneously (SC) immediately before meal Period 4:LY900014 administered SC 20 minutes after start of meal"
11323460|NCT03341299|OG000|Outcome|LY900014|All participants who received individualized dose of LY900014 SC before meal or 20 minutes after start of meal
11323461|NCT03341299|OG001|Outcome|Insulin Lispro (Humalog)|All participants who received individualized dose of insulin lispro (Humalog) SC before meal or 20 minutes after start of meal
11323462|NCT03341299|OG000|Outcome|LY900014 Before Meal|Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
11323463|NCT03341299|OG001|Outcome|LY900014 After Meal|Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
11323464|NCT03341299|OG002|Outcome|Insulin Lispro (Humalog) Before Meal|Individualized dose of insulin lispro (Humalog) administered SC immediately before meal in one of four study periods.
11323465|NCT03341299|OG003|Outcome|Insulin Lispro (Humalog) After Meal|Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
11323466|NCT03341299|EG000|Reported Event|LY900014 Before Meal|Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
11323467|NCT03341299|EG001|Reported Event|LY900014 After Meal|Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
11323468|NCT03341299|EG002|Reported Event|Insulin Lispro (Humalog) Before Meal|Individualized dose of insulin lispro (Humalog) administered SC immediately before meal in one of four study periods.
11323469|NCT03341299|EG003|Reported Event|Insulin Lispro (Humalog) After Meal|Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
11323470|NCT03341312|BG000|Baseline|Overall Study|All randomized participants who received at least 1 dose of study drug.
11323471|NCT03341312|FG000|Participant Flow|Cohort 1|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 3:LY900014 administered SC 20 minutes after start of meal Period 4: insulin lispro administered SC immediately before meal"
11323472|NCT03341312|FG001|Participant Flow|Cohort 2|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1:LY900014 administered SC 20 minutes after start of meal Period 2: LY900014 administered subcutaneously (SC) immediately before meal Period 3: insulin lispro (Humalog) administered SC immediately before meal Period 4: insulin lispro (Humalog) administered SC 20 minutes after start of meal"
11323473|NCT03341312|FG002|Participant Flow|Cohort 3|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: insulin lispro (Humalog) administered SC immediately before meal Period 2:LY900014 administered SC 20 minutes after start of meal Period 3: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 4: LY900014 administered subcutaneously (SC) immediately before meal"
11323474|NCT03341312|FG003|Participant Flow|Cohort 4|"Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses~Period 1: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 2: insulin lispro (Humalog) administered SC immediately before meal Period 3: LY900014 administered subcutaneously (SC) immediately before meal Period 4:LY900014 administered SC 20 minutes after start of meal"
11323475|NCT03341312|OG000|Outcome|LY900014|All participants who received individualized dose of LY900014 SC before meal or 20 minutes after start of meal
11323476|NCT03341312|OG001|Outcome|Insulin Lispro (Humalog)|All participants who received individualized dose of insulin lispro (Humalog) SC before meal or 20 minutes after start of meal
11323477|NCT03341312|OG000|Outcome|LY900014 Before Meal|Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
11323478|NCT03341312|OG001|Outcome|LY900014 After Meal|Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
11323479|NCT03341312|OG002|Outcome|Insulin Lispro (Humalog) Before Meal|Individualized dose of insulin lispro (Humalog)administered SC immediately before meal in one of four study periods.
11323480|NCT03341312|OG003|Outcome|Insulin Lispro (Humalog) After Meal|Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
11323481|NCT03341312|EG000|Reported Event|LY900014 Before Meal|Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
11323482|NCT03341312|EG001|Reported Event|LY900014 After Meal|Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
11323483|NCT03341312|EG002|Reported Event|Insulin Lispro (Humalog) Before Meal|Individualized dose of insulin lispro (Humalog) administered SC immediately before meal in one of four study periods.
11323484|NCT03341312|EG003|Reported Event|Insulin Lispro (Humalog) After Meal|Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
11323485|NCT03341507|BG000|Baseline|Tracheal Intubation With the Rigid Tube for Laryngoscopy|The study involved adult patients with ASA physical status 1-3, requiring surgery for an ENT pathology and having a presumed anatomically difficult airway according to The Simplified Airway Risk Index (SARI) score . Signed informed consent was obtained from all patients.
11323486|NCT03341507|FG000|Participant Flow|Laryngoscopy and Tracheal Intubation|"Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a Mcintosh laryngoscope will be performed.~classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.~rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed if the Cormack -Lehane glottis view is 2b,3 or 4 during conventional laryngoscopy"
11323487|NCT03341507|OG000|Outcome|Laryngoscopy and Tracheal Intubation|"Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a Mcintosh laryngoscope will be performed.~classical laryngoscopy: the laryngoscopy with the Mcintosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.~rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed"
11323488|NCT03341507|EG000|Reported Event|Laryngoscopy and Tracheal Intubation|"Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed.~classical laryngoscopy: the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.~rigid tube for laryngoscopy: the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed"
11323489|NCT03341533|BG000|Baseline|Ice Packs Plus Usual Post-op Analgesia|"Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.~Ice packs plus usual post-op analgesia: A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323490|NCT03341533|BG001|Baseline|Usual Post-op Analgesia|"Standard post-operative analgesia only, no ice use.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323491|NCT03341533|BG002|Baseline|Total|Total of all reporting groups
11323492|NCT03341533|FG000|Participant Flow|Ice Packs Plus Usual Post-op Analgesia|"Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.~Ice packs plus usual post-op analgesia: A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323493|NCT03341533|FG001|Participant Flow|Usual Post-op Analgesia|"Standard post-operative analgesia only, no ice use.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323494|NCT03341533|OG000|Outcome|Ice Packs Plus Usual Post-op Analgesia|"Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.~Ice packs plus usual post-op analgesia: A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323495|NCT03341533|OG001|Outcome|Usual Post-op Analgesia|"Standard post-operative analgesia only, no ice use.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323496|NCT03341533|EG000|Reported Event|Ice Packs Plus Usual Post-op Analgesia|"Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.~Ice packs plus usual post-op analgesia: A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323497|NCT03341533|EG001|Reported Event|Usual Post-op Analgesia|"Standard post-operative analgesia only, no ice use.~Usual post-op analgesia: Standard post-operative analgesia orders will be followed."
11323498|NCT03341546|BG000|Baseline|Patient Cohort|"20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination. All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination. An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.~A single measurement of the patient's abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth"
11323499|NCT03341546|FG000|Participant Flow|Patient Cohort|"20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination. All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination. An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.~A single measurement of the patient's abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth"
11323500|NCT03341546|OG000|Outcome|Patient Cohort|"20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination. All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination. An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.~A single measurement of the patient's abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth"
11323501|NCT03341546|EG000|Reported Event|Patient Cohort|"20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination. All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination. An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.~A single measurement of the patient's abdominal depth: A single measurement of the patient's anterior-posterior abdominal depth"
11323502|NCT03341637|BG000|Baseline|Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323503|NCT03341637|BG001|Baseline|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323504|NCT03341637|BG002|Baseline|Total|Total of all reporting groups
11323505|NCT03341637|FG000|Participant Flow|Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323506|NCT03341637|FG001|Participant Flow|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323507|NCT03341637|OG000|Outcome|Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323508|NCT03341637|OG001|Outcome|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323509|NCT03341637|EG000|Reported Event|Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323510|NCT03341637|EG001|Reported Event|Tetravalent Dengue Vaccine (TDV)|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
11323511|NCT03341728|BG000|Baseline|All Participants|"Older adults will walk during exposure to optical flow perturbations~Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.~Normal walking"
11323512|NCT03341728|FG000|Participant Flow|Intervention, Then Control|"Older adults will first walk during exposure to optical flow perturbations~Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.~Normal walking"
11323513|NCT03341728|FG001|Participant Flow|Control, Then Intervention|"Older adults will first walk normally (without optical flow perturbations)~Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.~Normal walking"
11323514|NCT03341728|OG000|Outcome|Intervention|"Older adults will walk during exposure to optical flow perturbations~Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality."
11323515|NCT03341728|OG001|Outcome|Normal Walking (Control)|Older adults will first walk normally (without optical flow perturbations)
11323516|NCT03341728|EG000|Reported Event|Intervention|"Older adults will walk during exposure to optical flow perturbations~Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality."
11323517|NCT03341728|EG001|Reported Event|Normal Walking (Control)|Older adults will first walk normally (without optical flow perturbations)
11323518|NCT03341910|BG000|Baseline|DFD-03 Lotion, 0.1%|"DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off~DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323519|NCT03341910|BG001|Baseline|Tazorac Cream, 0.1%|"Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323520|NCT03341910|BG002|Baseline|DFD-03 Vehicle Lotion|"Vehicle Lotion to be applied twice daily for 1 minute and rinsed off~DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323521|NCT03341910|BG003|Baseline|Tazorac Vehicle Cream|"Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323522|NCT03341910|BG004|Baseline|Total|Total of all reporting groups
11323523|NCT03341910|FG000|Participant Flow|DFD-03 Lotion, 0.1%|"DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off~DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323524|NCT03341910|FG001|Participant Flow|Tazorac Cream, 0.1%|"Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323525|NCT03341910|FG002|Participant Flow|DFD-03 Vehicle Lotion|"Vehicle Lotion to be applied twice daily for 1 minute and rinsed off~DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323526|NCT03341910|FG003|Participant Flow|Tazorac Vehicle Cream|"Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323527|NCT03341910|OG000|Outcome|DFD-03 Lotion, 0.1%|"DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off~DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323528|NCT03341910|OG001|Outcome|Tazorac Cream, 0.1%|"Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323529|NCT03341910|OG002|Outcome|DFD-03 Vehicle Lotion|"Vehicle Lotion to be applied twice daily for 1 minute and rinsed off~DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323530|NCT03341910|OG003|Outcome|Tazorac Vehicle Cream|"Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours~Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323531|NCT03341910|EG000|Reported Event|DFD-03 Lotion, 0.1%|"DFD-03 Lotion, 0.1% was applied twice daily approximately 12 hours apart, for 1 minute and rinsed off~DFD-03 Lotion, 0.1%: DFD-03 Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323532|NCT03341910|EG001|Reported Event|Tazorac Cream, 0.1%|"Tazorac Cream, 0.1% was applied once in the evening and left overnight for approximately 12 hours~Tazorac Cream, 0.1%: Tazorac Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323533|NCT03341910|EG002|Reported Event|Vehicle Lotion|"Vehicle Lotion was applied twice daily for 1 minute and rinsed off~DFD-03 Vehicle Lotion 0%: Vehicle Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute."
11323534|NCT03341910|EG003|Reported Event|Vehicle Cream|"Vehicle Cream was applied once in the evening and left overnight for approximately 12 hours~Tazorac Vehicle Cream 0%: Vehicle Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight."
11323535|NCT03341923|BG000|Baseline|Overall|Delefilcon A multifocal contact lenses and etafilcon A multifocal contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11323536|NCT03341923|FG000|Participant Flow|DT1MF, Then AMMF|Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
11323537|NCT03341923|FG001|Participant Flow|AMMF, Then DT1MF|Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
11323538|NCT03341923|OG000|Outcome|DT1MF|Delefilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.
11323539|NCT03341923|OG001|Outcome|AMMF|Etafilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.
11323540|NCT03341923|EG000|Reported Event|DT1MF Ocular|Eyes exposed to delefilcon A multifocal contact lenses
11323541|NCT03341923|EG001|Reported Event|DT1MF Systemic|Subjects exposed to delefilcon A multifocal contact lenses
11323542|NCT03341923|EG002|Reported Event|AMMF Ocular|Eyes exposed to etafilcon A multifocal contact lenses
11323543|NCT03341923|EG003|Reported Event|AMMF Systemic|Subjects exposed to etafilcon A multifocal contact lenses
11323544|NCT03341975|BG000|Baseline|Intervention|"They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.~SexHealth: To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care."
11323545|NCT03341975|BG001|Baseline|Control|They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
11323546|NCT03341975|BG002|Baseline|Total|Total of all reporting groups
11323547|NCT03341975|FG000|Participant Flow|Intervention|"They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.~SexHealth: To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care."
11323548|NCT03341975|FG001|Participant Flow|Control|They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
11323549|NCT03341975|OG000|Outcome|Intervention|"They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.~SexHealth: To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care."
11323550|NCT03341975|OG001|Outcome|Control|They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
11323551|NCT03341975|EG000|Reported Event|Intervention|"They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.~SexHealth: To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care."
11323552|NCT03341975|EG001|Reported Event|Control|They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
11323553|NCT03342404|BG000|Baseline|Luspatercept|Luspatercept SC 1mg/Kg Q3W
11323554|NCT03342404|BG001|Baseline|Placebo|0.9% Sodium Chloride SC Q3W
11323555|NCT03342404|BG002|Baseline|Total|Total of all reporting groups
11323556|NCT03342404|FG000|Participant Flow|Luspatercept|Luspatercept SC 1mg/Kg Q3W
11323557|NCT03342404|FG001|Participant Flow|Placebo|0.9% Sodium Chloride SC Q3W
11323558|NCT03342404|OG000|Outcome|Luspatercept|Luspatercept SC 1mg/Kg Q3W
11323559|NCT03342404|OG001|Outcome|Placebo|0.9% Sodium Chloride SC Q3W
11323560|NCT03342404|EG000|Reported Event|Luspatercept|Luspatercept SC 1mg/Kg Q3W
11323561|NCT03342404|EG001|Reported Event|Placebo|0.9% Sodium Chloride SC Q3W
11323562|NCT03342469|BG000|Baseline|ADHD Group|College students diagnosed with ADHD.
11323563|NCT03342469|BG001|Baseline|Control Group|College students not diagnosed with ADHD
11323564|NCT03342469|BG002|Baseline|Total|Total of all reporting groups
11323565|NCT03342469|FG000|Participant Flow|ADHD- Artificial Food Coloring Challenge First, Then Placebo|"A high consumer child dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). The chocolate will mask the food coloring. The next week they will received placebo cookies for three days.~Artificial Food Coloring: Artificial Food Coloring (AFC)"
11323566|NCT03342469|FG001|Participant Flow|ADHD- Placebo Challenge First, Then Artificial Food Coloring|The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday).
11323567|NCT03342469|FG002|Participant Flow|Control - Artificial Food Coloring First, Then Placebo|A high consumer child dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). The chocolate will mask the food coloring. The next week they will received placebo cookies for three days.
11323568|NCT03342469|FG003|Participant Flow|Control - Placebo First, Then Artificial Food Coloring|The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday).
11323569|NCT03342469|OG000|Outcome|ADHD- Artificial Food Coloring|225 mg AFC over three days received either the first or second week.
11323570|NCT03342469|OG001|Outcome|ADHD- Placebo|Placebo cookies over three days received either the first for second week.
11323571|NCT03342469|OG002|Outcome|Control - Artificial Food Coloring|225 mg AFC over three days received either the first or second week.
11323572|NCT03342469|OG003|Outcome|Control - Placebo|Placebo cookies over three days received either the first or second week.
11323573|NCT03342469|OG000|Outcome|ADHD- Artificial Food Coloring|225 mg of mixed AFC over three days received either the first or second week.
11323574|NCT03342469|OG001|Outcome|ADHD - Placebo Challenge|Placebo cookies over three days received either the first or second week.
11323575|NCT03342469|OG002|Outcome|Control - Artificial Food Coloring|225 mg of mixed AFC over three days received either the first or second week.
11323576|NCT03342469|EG000|Reported Event|Artificial Food Coloring Challenge|"ADHD and control participants combined.~A high consumer child dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday)."
11323577|NCT03342469|EG001|Reported Event|Placebo Challenge|"ADHD and control participants, combined.~The participants will consume chocolate cookies with no food coloring for three days."
11323578|NCT03342560|BG000|Baseline|30 Patients With Known Liver Biopsy Results|"Patients with chronic liver disease with known biopsy results~Sonographic SWE measurements with Toshiba APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis~Sonographic speed of sound measurements with GE LOGIQ E9: Sonographic speed of sound function of the machine will be used to quantify liver steatosis"
11323579|NCT03342560|FG000|Participant Flow|Chronic Liver Disease Patients With Known Liver Biopsy Results|"Patients with chronic liver disease with known biopsy results~Sonographic SWE measurements with Toshiba/Canon APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis"
11323580|NCT03342560|OG000|Outcome|Guideline Suggested Measurements|10 measurements in an area between 2cm from liver capsule and 6.5cm from skin
11323581|NCT03342560|OG001|Outcome|Fewer Number of Measurements|3 SWE measurements were collected.
11323582|NCT03342560|OG002|Outcome|Free Breath Measurements|10 SWE measurements were collected during free breath
11323583|NCT03342560|OG000|Outcome|Measurements in m/s Unit|In 20 patients, we collected 10 measurements at a depth between 2cm from liver capsule and 6.5 from skin.
11323584|NCT03342560|OG001|Outcome|Measurements in kPA Unit|In 20 patients, we collected 10 measurements at a depth between 2cm from liver capsule and 6.5 from skin.
11323585|NCT03342560|EG000|Reported Event|30 Patients With Known Liver Biopsy Results|"Patients with chronic liver disease with known biopsy results~Sonographic SWE measurements with Toshiba APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis~SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis~Sonographic speed of sound measurements with GE LOGIQ E9: Sonographic speed of sound function of the machine will be used to quantify liver steatosis"
11323586|NCT03342690|BG000|Baseline|Selara Tablets (Eplerenone)|Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11323587|NCT03342690|FG000|Participant Flow|Selara Tablets (Eplerenone)|Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11323588|NCT03342690|OG000|Outcome|Selara Tablets (Eplerenone)|Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11323589|NCT03342690|EG000|Reported Event|Selara Tablets (Eplerenone)|Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion.
11323590|NCT03342898|BG000|Baseline|Group 1: YF-17D + Placebo/TDV/TDV|YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
11323591|NCT03342898|BG001|Baseline|Group 2: TDV + Placebo/TDV/YF-17D|TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
11323592|NCT03342898|BG002|Baseline|Group 3: TDV + YF-17D/TDV/Placebo|TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
11323593|NCT03342898|BG003|Baseline|Total|Total of all reporting groups
11323594|NCT03342898|FG000|Participant Flow|Group 1: YF-17D + Placebo/TDV/TDV|YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
11323595|NCT03342898|FG001|Participant Flow|Group 2: TDV + Placebo/TDV/YF-17D|TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
11323596|NCT03342898|FG002|Participant Flow|Group 3: TDV + YF-17D/TDV/Placebo|TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
11323597|NCT03342898|OG000|Outcome|Group 1: YF-17D + Placebo/TDV/TDV|YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
11323598|NCT03342898|OG001|Outcome|Group 2: TDV + Placebo/TDV/YF-17D|TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
11323599|NCT03342898|OG002|Outcome|Group 3: TDV + YF-17D/TDV/Placebo|TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
11323600|NCT03342898|EG000|Reported Event|Group 1: YF-17D + Placebo/TDV/TDV|YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
11323601|NCT03342898|EG001|Reported Event|Group 2: TDV + Placebo/TDV/YF-17D|TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
11323602|NCT03342898|EG002|Reported Event|Group 3: TDV + YF-17D/TDV/Placebo|TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
11323603|NCT03342963|BG000|Baseline|Cohort 1: ASC-01 First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323604|NCT03342963|BG001|Baseline|Cohort 1: Aripiprazole/Sertraline Concomitant First|"At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323605|NCT03342963|BG002|Baseline|Cohort 2: ASC-01 Under Fasted First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.~There was a washout period of at least 35 days between Period I and Period II."
11323606|NCT03342963|BG003|Baseline|Cohort 2: ASC-01 Under Fed First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323607|NCT03342963|BG004|Baseline|Total|Total of all reporting groups
11323608|NCT03342963|FG000|Participant Flow|Cohort 1: ASC-01 First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323609|NCT03342963|FG001|Participant Flow|Cohort 1: Aripiprazole/Sertraline Concomitant First|"At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323610|NCT03342963|FG002|Participant Flow|Cohort 2: ASC-01 Under Fasted First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.~There was a washout period of at least 35 days between Period I and Period II."
11323611|NCT03342963|FG003|Participant Flow|Cohort 2: ASC-01 Under Fed First|"At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.~At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.~There was a washout period of at least 35 days between Period I and Period II."
11323612|NCT03342963|OG000|Outcome|ASC-01|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.
11323613|NCT03342963|OG001|Outcome|Aripiprazole/Sertraline Concomitant|Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.
11323614|NCT03342963|OG000|Outcome|ASC-01 Under Fasted|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.
11323615|NCT03342963|OG001|Outcome|ASC-01 Under Fed|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.
11323616|NCT03342963|EG000|Reported Event|Cohort 1 - ASC-01|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.
11323617|NCT03342963|EG001|Reported Event|Cohort 1 - Aripiprazole/Sertraline Concomitant|Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting.
11323618|NCT03342963|EG002|Reported Event|Cohort 2 - ASC-01 Under Fasted|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting.
11323619|NCT03342963|EG003|Reported Event|Cohort 2 - ASC-01 Under Fed|ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast.
11323620|NCT03343067|BG000|Baseline|Group A|"Day 1 through Month 3 (open-label): elagolix 150 mg QD~Participants discontinued prematurely during the open-label period."
11323621|NCT03343067|BG001|Baseline|Group B|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323622|NCT03343067|BG002|Baseline|Group C|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323623|NCT03343067|BG003|Baseline|Total|Total of all reporting groups
11323624|NCT03343067|FG000|Participant Flow|Group A|"Day 1 through Month 3 (open-label): elagolix 150 mg QD~Participants discontinued prematurely during the open-label period."
11323625|NCT03343067|FG001|Participant Flow|Group B|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323626|NCT03343067|FG002|Participant Flow|Group C|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window"
11323627|NCT03343067|OG000|Outcome|Group A|"Day 1 through Month 3 (open-label): elagolix 150 mg QD~Participants discontinued prematurely during the open-label period."
11323628|NCT03343067|OG001|Outcome|Group B|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323629|NCT03343067|OG002|Outcome|Group C|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323630|NCT03343067|EG000|Reported Event|Group A|"Day 1 through Month 3 (open-label): elagolix 150 mg QD~Participants discontinued prematurely during the open-label period."
11323631|NCT03343067|EG001|Reported Event|Group B|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323632|NCT03343067|EG002|Reported Event|Group C|"Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD~Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group~The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window."
11323633|NCT03343080|BG000|Baseline|Buffered Lidocaine|1.8% lidocaine plus 0.76% sodium bicarbonate: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water
11323634|NCT03343080|BG001|Baseline|Air Only|Air: At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
11323635|NCT03343080|BG002|Baseline|Total|Total of all reporting groups
11323636|NCT03343080|FG000|Participant Flow|Buffered Lidocaine|1.8% lidocaine plus 0.76% sodium bicarbonate: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water
11323637|NCT03343080|FG001|Participant Flow|Air Only|Air: At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
11323638|NCT03343080|OG000|Outcome|Buffered Lidocaine|1.8% lidocaine plus 0.76% sodium bicarbonate: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water
11323639|NCT03343080|OG001|Outcome|Air Only|Air: At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
11323640|NCT03343080|EG000|Reported Event|Buffered Lidocaine|1.8% lidocaine plus 0.76% sodium bicarbonate: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water
11323641|NCT03343080|EG001|Reported Event|Air Only|Air: At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
11323642|NCT03343639|BG000|Baseline|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
11323643|NCT03343639|BG001|Baseline|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
11323644|NCT03343639|BG002|Baseline|Total|Total of all reporting groups
11323645|NCT03343639|FG000|Participant Flow|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
11323646|NCT03343639|FG001|Participant Flow|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
11323647|NCT03343639|OG000|Outcome|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
11323648|NCT03343639|OG001|Outcome|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
11323649|NCT03343639|EG000|Reported Event|Serlopitant 5 mg|Subjects received a 3-tablet oral loading dose (15 mg) on the first day of the treatment period followed by a 5 mg dose of Serlopitant taken once daily by mouth for 8 weeks
11323650|NCT03343639|EG001|Reported Event|Placebo|Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a Placebo tablet taken once daily by mouth for 8 weeks
11323651|NCT03344172|BG000|Baseline|PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)~Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323652|NCT03344172|BG001|Baseline|PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323653|NCT03344172|BG002|Baseline|Total|Total of all reporting groups
11323654|NCT03344172|FG000|Participant Flow|PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)"
11323655|NCT03344172|FG001|Participant Flow|PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323656|NCT03344172|OG000|Outcome|PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab|"Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)~Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery~Day 1 of Cycle 3: avelumab (10mg/kg)"
11323657|NCT03344172|OG001|Outcome|PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)~Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323658|NCT03344172|EG000|Reported Event|PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)~Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323659|NCT03344172|EG001|Reported Event|PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine|"Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine~Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery"
11323660|NCT03344510|BG000|Baseline|All Participants|"All participants received two lidocaine injections - one on the left and one on the right side of the body, with the left side injection always administered first. One of the injections was performed with the kinetic anesthesia device assistance, while the other was performed without (the control injection).~As noted in the protocol, participants were randomized to receive the kinetic anesthesia device assisted injection first or second. 21 participants received the kinetic anesthesia device assisted injection first, while 26 were randomized to receive it second.~Kinetic Anesthesia Device: A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain"
11323661|NCT03344510|FG000|Participant Flow|Kinetic Anesthesia Device, Then no Intervention|In this arm of the crossover study, participants will receive lidocaine injection in conjunction with the kinetic anesthesia device, then will receive an injection without the kinetic anesthesia device intervention
11323662|NCT03344510|FG001|Participant Flow|No Intervention, Then Kinetic Anesthesia Device|In this arm of the crossover study, participants will receive lidocaine injection without the kinetic anesthesia device intervention, then will receive an injection in conjunction with the kinetic anesthesia device.
11323663|NCT03344510|OG000|Outcome|Injections Using the Kinetic Anesthesia Device|"Participants graded the pain of lidocaine injection perfomed in conjunction with the kinetic anesthesia device~Kinetic Anesthesia Device: A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain"
11323664|NCT03344510|OG001|Outcome|Injections Without Kinetic Anesthesia Device|Participants graded the pain of lidocaine injection with no intervention
11323665|NCT03344510|OG000|Outcome|Kinetic Anesthesia Device Injection|"Participants received the lidocaine injection in conjunction with the kinetic anesthesia device~Kinetic Anesthesia Device: A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain"
11323666|NCT03344510|OG001|Outcome|Control Injection|Participants received lidocaine injection with no intervention
11323667|NCT03344510|EG000|Reported Event|All Participants|"All participants received two lidocaine injections - one on the left and one on the right side of the body, with the left side injection always administered first. One of the injections was performed with the kinetic anesthesia device assistance, while the other was performed without (the control injection).~As noted in the protocol, participants were randomized to receive the kinetic anesthesia device assisted injection first or second. 21 participants received the kinetic anesthesia device assisted injection first, while 26 were randomized to receive it second.~Kinetic Anesthesia Device: A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain"
11323668|NCT03344640|BG000|Baseline|Secukinumab|AIN457 300 mg subcutaneously (s.c.)
11323669|NCT03344640|BG001|Baseline|Placebo|Placebo s.c.
11323670|NCT03344640|BG002|Baseline|Total|Total of all reporting groups
11323671|NCT03344640|FG000|Participant Flow|Secukinumab|AIN457 300 mg subcutaneously (s.c.)
11323672|NCT03344640|FG001|Participant Flow|Placebo|Placebo s.c.
11323673|NCT03344640|OG000|Outcome|Secukinumab|AIN457 300 mg subcutaneously (s.c.)
11323674|NCT03344640|OG001|Outcome|Placebo|Placebo s.c.
11323675|NCT03344640|EG000|Reported Event|AIN457 300 mg s.c.|AIN457 300 mg
11323676|NCT03344640|EG001|Reported Event|Placebo|Placebo s.c.
11333481|NCT03515941|FG001|Participant Flow|Arm 2: Adjuvant Chemoradiation|"Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)~radiation: 45 Gy in 1.8 Gy/fraction"
11333482|NCT03515941|OG000|Outcome|Arm 1: Adjuvant Chemotherapy|"Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle~Oxaliplatin: 130 mg/m2 by IV (Arm 1)~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)"
11333483|NCT03515941|OG001|Outcome|Arm 2: Adjuvant Chemoradiation|"Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)~radiation: 45 Gy in 1.8 Gy/fraction"
11333484|NCT03515941|EG000|Reported Event|Arm 1: Adjuvant Chemotherapy|"Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle~Oxaliplatin: 130 mg/m2 by IV (Arm 1)~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)"
11333485|NCT03515941|EG001|Reported Event|Arm 2: Adjuvant Chemoradiation|"Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.~Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)~Leucovorin: 400 mg/m2 by IV (Arm 1 & Arm 2)~5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)~radiation: 45 Gy in 1.8 Gy/fraction"
11333486|NCT03516227|BG000|Baseline|HRVBF|"Heart rate variability biofeedback~heart rate variability biofeedback: The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA). The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months."
11333487|NCT03516227|BG001|Baseline|Control|Usual Care
11333488|NCT03516227|BG002|Baseline|Total|Total of all reporting groups
11333489|NCT03516227|FG000|Participant Flow|HRVBF|"Heart rate variability biofeedback~heart rate variability biofeedback: The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA).26 The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months."
11333490|NCT03516227|FG001|Participant Flow|Control|Usual Care
11333491|NCT03516227|OG000|Outcome|HRVBF|"Heart rate variability biofeedback~heart rate variability biofeedback: The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA).26 The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months."
11333492|NCT03516227|OG001|Outcome|Control|Usual Care
11323677|NCT03344861|BG000|Baseline|Photofrin and Photodynamic Therapy|Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT.
11323678|NCT03344861|FG000|Participant Flow|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.~Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.~Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length."
11323679|NCT03344861|OG000|Outcome|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.~Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.~Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length."
11323680|NCT03344861|EG000|Reported Event|Photodynamic Therapy-Photofrin|"Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.~Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.~Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length."
11323681|NCT03345108|BG000|Baseline|Overall|Includes participants with conventional application of adhesive, continuous strip application of adhesive and no adhesive
11323682|NCT03345108|FG000|Participant Flow|A-B-C|Sequence of the treatment if A-B-C, where A-conventional application; B- continuous strip application; C- no adhesive
11323683|NCT03345108|FG001|Participant Flow|A-C-B|Sequence of the treatment if A-C-B, where A-conventional application; B- continuous strip application; C- no adhesive
11323684|NCT03345108|FG002|Participant Flow|B-A-C|Sequence of the treatment if B-A-C, where A-conventional application; B- continuous strip application; C- no adhesive
11323685|NCT03345108|FG003|Participant Flow|B-C-A|Sequence of the treatment if B-C-A, where A-conventional application; B- continuous strip application; C- no adhesive
11323686|NCT03345108|FG004|Participant Flow|C-A-B|Sequence of the treatment if C-A-B, where A-conventional application; B- continuous strip application; C- no adhesive
11323687|NCT03345108|FG005|Participant Flow|C-B-A|Sequence of the treatment if C-B-A, where A-conventional application; B- continuous strip application; C- no adhesive
11323688|NCT03345108|OG000|Outcome|Conventional Application|Participants received the 1.6 grams (g) of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in conventional pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in short strips (3 strips to the upper denture and 2 strips on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
11323689|NCT03345108|OG001|Outcome|Continuous Strip Application|Participants received the 1.6 g of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in continuous strip pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in long, continuous strips (3 strips to the upper denture and 1 strip on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
11323690|NCT03345108|OG002|Outcome|No Adhesive|Participants did not receive any denture adhesive in this group.
11323691|NCT03345108|EG000|Reported Event|Conventional Application|Participants received the 1.6 grams (g) of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in conventional pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in short strips (3 strips to the upper denture and 2 strips on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
11323692|NCT03345108|EG001|Reported Event|Continuous Strip Application|Participants received the 1.6 g of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in continuous strip pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in long, continuous strips (3 strips to the upper denture and 1 strip on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
11323693|NCT03345108|EG002|Reported Event|No Adhesive|Participants did not receive any denture adhesive in this group.
11323694|NCT03345160|BG000|Baseline|Peanut Flour: Open Label Peanut OIT|"This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study~Peanut Flour: open label oral immunotherapy"
11323695|NCT03345160|FG000|Participant Flow|Peanut Flour: Open Label Peanut OIT|"This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut oral immunotherapy (OIT) study~Peanut Flour: open label oral immunotherapy"
11323696|NCT03345160|OG000|Outcome|Peanut Flour: Open Label Peanut OIT|"This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study~Peanut Flour: open label oral immunotherapy"
11323697|NCT03345160|EG000|Reported Event|Peanut Flour: Open Label Peanut OIT|"This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study~Peanut Flour: open label oral immunotherapy"
11323698|NCT03345394|BG000|Baseline|Standard Treatment|"12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program~Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program"
11323699|NCT03345394|BG001|Baseline|Contingency Management|"12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management~Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples"
11323700|NCT03345394|BG002|Baseline|Total|Total of all reporting groups
11323701|NCT03345394|FG000|Participant Flow|Standard Treatment|"12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program~Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program"
11323702|NCT03345394|FG001|Participant Flow|Contingency Management|"12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management~Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples"
11323703|NCT03345394|OG000|Outcome|Standard Treatment|"12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program~Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program"
11323704|NCT03345394|OG001|Outcome|Contingency Management|"12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management~Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples"
11323705|NCT03345394|EG000|Reported Event|Standard Treatment|"12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program~Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program"
11323706|NCT03345394|EG001|Reported Event|Contingency Management|"12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management~Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples"
11323707|NCT03345407|BG000|Baseline|Placebo|Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
11323708|NCT03345407|BG001|Baseline|Nemiralisib 12.5 mcg|Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323709|NCT03345407|BG002|Baseline|Nemiralisib 50 mcg|Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323710|NCT03345407|BG003|Baseline|Nemiralisib 100 mcg|Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323711|NCT03345407|BG004|Baseline|Nemiralisib 250 mcg|Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323712|NCT03345407|BG005|Baseline|Nemiralisib 500 mcg|Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323713|NCT03345407|BG006|Baseline|Nemiralisib 750 mcg|Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323714|NCT03345407|BG007|Baseline|Total|Total of all reporting groups
11323715|NCT03345407|FG000|Participant Flow|Placebo|Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
11323716|NCT03345407|FG001|Participant Flow|Nemiralisib 12.5 mcg|Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323717|NCT03345407|FG002|Participant Flow|Nemiralisib 50 mcg|Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323718|NCT03345407|FG003|Participant Flow|Nemiralisib 100 mcg|Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323719|NCT03345407|FG004|Participant Flow|Nemiralisib 250 mcg|Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323720|NCT03345407|FG005|Participant Flow|Nemiralisib 500 mcg|Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323721|NCT03345407|FG006|Participant Flow|Nemiralisib 750 mcg|Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323722|NCT03345407|OG000|Outcome|Placebo|Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
11323723|NCT03345407|OG001|Outcome|Nemiralisib 12.5 mcg|Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323724|NCT03345407|OG002|Outcome|Nemiralisib 50 mcg|Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323725|NCT03345407|OG003|Outcome|Nemiralisib 100 mcg|Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323726|NCT03345407|OG004|Outcome|Nemiralisib 250 mcg|Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323727|NCT03345407|OG005|Outcome|Nemiralisib 500 mcg|Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323728|NCT03345407|OG006|Outcome|Nemiralisib 750 mcg|Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323729|NCT03345407|OG000|Outcome|Nemiralisib 12.5 mcg|Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323730|NCT03345407|OG001|Outcome|Nemiralisib 50 mcg|Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323731|NCT03345407|OG002|Outcome|Nemiralisib 100 mcg|Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323732|NCT03345407|OG003|Outcome|Nemiralisib 250 mcg|Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323733|NCT03345407|OG004|Outcome|Nemiralisib 500 mcg|Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323734|NCT03345407|OG005|Outcome|Nemiralisib 750 mcg|Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323735|NCT03345407|EG000|Reported Event|Placebo|Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
11323736|NCT03345407|EG001|Reported Event|Nemiralisib 12.5 mcg|Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323737|NCT03345407|EG002|Reported Event|Nemiralisib 50 mcg|Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323738|NCT03345407|EG003|Reported Event|Nemiralisib 100 mcg|Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323739|NCT03345407|EG004|Reported Event|Nemiralisib 250 mcg|Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323740|NCT03345407|EG005|Reported Event|Nemiralisib 500 mcg|Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323741|NCT03345407|EG006|Reported Event|Nemiralisib 750 mcg|Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
11323742|NCT03345472|BG000|Baseline|Treated|"Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.~Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters."
11323743|NCT03345472|FG000|Participant Flow|Treated|"Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.~Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters."
11323744|NCT03345472|OG000|Outcome|Treated|"Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.~Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters."
11323745|NCT03345472|EG000|Reported Event|Treated|"Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.~Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters."
11323746|NCT03345914|BG000|Baseline|Placebo + TCS|Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.
11323747|NCT03345914|BG001|Baseline|Dupilumab 300 mg Q4W + TCS|Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.
11323748|NCT03345914|BG002|Baseline|Dupilumab 100 mg or 200 mg Q2W + TCS|Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
11323749|NCT03345914|BG003|Baseline|Total|Total of all reporting groups
11323750|NCT03345914|FG000|Participant Flow|Placebo + TCS|Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.
11323751|NCT03345914|FG001|Participant Flow|Dupilumab 300 mg Q4W + TCS|Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.
11323752|NCT03345914|FG002|Participant Flow|Dupilumab 100 mg or 200 mg Q2W + TCS|Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
11323753|NCT03345914|OG000|Outcome|Placebo + TCS|Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.
11323754|NCT03345914|OG001|Outcome|Dupilumab 300 mg Q4W + TCS|Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.
11323755|NCT03345914|OG002|Outcome|Dupilumab 100 mg or 200 mg Q2W + TCS|Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
11323756|NCT03345914|EG000|Reported Event|Placebo + TCS|Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.
11323757|NCT03345914|EG001|Reported Event|Dupilumab 300 mg Q4W + TCS|Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.
11323758|NCT03345914|EG002|Reported Event|Dupilumab 100 mg or 200 mg Q2W + TCS|Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
11323759|NCT03345979|BG000|Baseline|Aripiprazole Lauroxil|Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter
11323760|NCT03345979|BG001|Baseline|Paliperidone Palmitate|Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter
11323761|NCT03345979|BG002|Baseline|Total|Total of all reporting groups
11323762|NCT03345979|FG000|Participant Flow|Aripiprazole Lauroxil|Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter
11323763|NCT03345979|FG001|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter
11323764|NCT03345979|OG000|Outcome|Aripiprazole Lauroxil|Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter
11323765|NCT03345979|OG001|Outcome|Paliperidone Palmitate|Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter
11323766|NCT03345979|EG000|Reported Event|Aripiprazole Lauroxil|Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter
11323767|NCT03345979|EG001|Reported Event|Paliperidone Palmitate|Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter
11323768|NCT03346057|BG000|Baseline|Sugammadex 2 mg/kg|Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
11323769|NCT03346057|BG001|Baseline|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg administered as a single IV dose
11323770|NCT03346057|BG002|Baseline|Sugammadex 16 mg/kg|Sugammadex 16 mg/kg administered as a single IV dose
11323771|NCT03346057|BG003|Baseline|Neostigmine + Glycopyrrolate|Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
11323772|NCT03346057|BG004|Baseline|Total|Total of all reporting groups
11323773|NCT03346057|FG000|Participant Flow|Sugammadex 2 mg/kg|Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
11323774|NCT03346057|FG001|Participant Flow|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg administered as a single IV dose
11323775|NCT03346057|FG002|Participant Flow|Sugammadex 16 mg/kg|Sugammadex 16 mg/kg administered as a single IV dose
11323776|NCT03346057|FG003|Participant Flow|Neostigmine + Glycopyrrolate|Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
11323777|NCT03346057|OG000|Outcome|Sugammadex 2 mg/kg|Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
11323778|NCT03346057|OG001|Outcome|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg administered as a single IV dose
11323779|NCT03346057|OG002|Outcome|Sugammadex 16 mg/kg|Sugammadex 16 mg/kg administered as a single IV dose
11323780|NCT03346057|OG003|Outcome|Neostigmine + Glycopyrrolate|Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
11323781|NCT03346057|EG000|Reported Event|Sugammadex 2 mg/kg|Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
11323782|NCT03346057|EG001|Reported Event|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg administered as a single IV dose
11323783|NCT03346057|EG002|Reported Event|Sugammadex 16 mg/kg|Sugammadex 16 mg/kg administered as a single IV dose
11323784|NCT03346057|EG003|Reported Event|Neostigmine + Glycopyrrolate|Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
11323785|NCT03346070|BG000|Baseline|Sugammadex 2 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323786|NCT03346070|BG001|Baseline|Sugammadex 4 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323787|NCT03346070|BG002|Baseline|Sugammadex 2 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323788|NCT03346070|BG003|Baseline|Sugammadex 4 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323789|NCT03346070|BG004|Baseline|Neostigmine/Glycopyrrolate|Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
11323790|NCT03346070|BG005|Baseline|Total|Total of all reporting groups
11323791|NCT03346070|FG000|Participant Flow|Sugammadex 2 mg/kg Actual Body Weight (ABW)|Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323792|NCT03346070|FG001|Participant Flow|Sugammadex 4 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323793|NCT03346070|FG002|Participant Flow|Sugammadex 2 mg/kg Ideal Body Weight (IBW)|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323794|NCT03346070|FG003|Participant Flow|Sugammadex 4 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323795|NCT03346070|FG004|Participant Flow|Neostigmine/Glycopyrrolate|Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
11323796|NCT03346070|OG000|Outcome|Sugammadex 2 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323797|NCT03346070|OG001|Outcome|Sugammadex 4 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323798|NCT03346070|OG002|Outcome|Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)|Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.
11323799|NCT03346070|OG003|Outcome|Sugammadex 2 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323800|NCT03346070|OG004|Outcome|Sugammadex 4 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323801|NCT03346070|OG005|Outcome|Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)|Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.
11323802|NCT03346070|OG006|Outcome|Neostigmine/Glycopyrrolate|Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
11323803|NCT03346070|EG000|Reported Event|Sugammadex 2 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323804|NCT03346070|EG001|Reported Event|Sugammadex 4 mg/kg ABW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323805|NCT03346070|EG002|Reported Event|Sugammadex 2 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
11323806|NCT03346070|EG003|Reported Event|Sugammadex 4 mg/kg IBW|Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
11323807|NCT03346070|EG004|Reported Event|Neostigmine + Glycopyrrolate|Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
11323808|NCT03346161|BG000|Baseline|Arm 1: BREASTChoice (Decision Tool)|Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.
11323809|NCT03346161|BG001|Baseline|Arm 2: Enhanced Usual Care (Surgical Care Booklet)|"Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet Breast Reconstruction. They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes."
11323810|NCT03346161|BG002|Baseline|Total|Total of all reporting groups
11323811|NCT03346161|FG000|Participant Flow|Arm 1: BREASTChoice (Decision Tool)|Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.
11333493|NCT03516227|OG000|Outcome|HRVBF|"Heart rate variability biofeedback~heart rate variability biofeedback: The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA). The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months."
11333494|NCT03516227|EG000|Reported Event|HRVBF|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11323812|NCT03346161|FG001|Participant Flow|Arm 2: Enhanced Usual Care (Surgical Care Booklet)|"Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet Breast Reconstruction. They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes."
11323813|NCT03346161|OG000|Outcome|Arm 1: BREASTChoice (Decision Tool)|Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.
11323814|NCT03346161|OG001|Outcome|Arm 2: Enhanced Usual Care (Surgical Care Booklet)|"Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet Breast Reconstruction. They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes."
11323815|NCT03346161|EG000|Reported Event|Arm 1: BREASTChoice (Decision Tool)|Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.
11323816|NCT03346161|EG001|Reported Event|Arm 2: Enhanced Usual Care (Surgical Care Booklet)|"Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet Breast Reconstruction. They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes."
11323817|NCT03346759|BG000|Baseline|Tampon A First|Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323818|NCT03346759|BG001|Baseline|Tampon B First|Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323819|NCT03346759|BG002|Baseline|Total|Total of all reporting groups
11323820|NCT03346759|FG000|Participant Flow|Tampon A First|Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323821|NCT03346759|FG001|Participant Flow|Tampon B First|Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323822|NCT03346759|OG000|Outcome|Tampon A First|Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323823|NCT03346759|OG001|Outcome|Tampon B First|Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
11323824|NCT03346759|EG000|Reported Event|Tampon A|All participants while using Tampax Pearl Regular Tampons regardless of tampon sequence.
11323825|NCT03346759|EG001|Reported Event|Tampon B|All participants while using Playtex Gentle Glide 360 Regular Tampons regardless of tampon sequence.
11323826|NCT03346759|EG002|Reported Event|Tampon of Choice (Third Period)|All participants during the third menstrual cycle.
11323827|NCT03346850|BG000|Baseline|Nasogastric Tube (NGT) Feeding|Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
11323828|NCT03346850|BG001|Baseline|Nasoduodenal Tube (NDT) Feeding|Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
11323829|NCT03346850|BG002|Baseline|Total|Total of all reporting groups
11323830|NCT03346850|FG000|Participant Flow|Nasogastric Tube (NGT) Feeding|Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
11323831|NCT03346850|FG001|Participant Flow|Nasoduodenal Tube (NDT) Feeding|Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
11323832|NCT03346850|OG000|Outcome|Nasogastric Tube (NGT) Feeding|Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
11323833|NCT03346850|OG001|Outcome|Nasoduodenal Tube (NDT) Feeding|Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
11323834|NCT03346850|EG000|Reported Event|Nasogastric Tube (NGT) Feeding|Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
11323835|NCT03346850|EG001|Reported Event|Nasoduodenal Tube (NDT) Feeding|Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
11323836|NCT03346902|BG000|Baseline|Placebo|0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
11323837|NCT03346902|BG001|Baseline|EB001|EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
11323838|NCT03346902|BG002|Baseline|Total|Total of all reporting groups
11323839|NCT03346902|FG000|Participant Flow|Placebo|0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
11323840|NCT03346902|FG001|Participant Flow|EB001|EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead).
11323841|NCT03346902|OG000|Outcome|Placebo|0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
11323842|NCT03346902|OG001|Outcome|EB001|EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
11323843|NCT03346902|EG000|Reported Event|Placebo|0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
11323844|NCT03346902|EG001|Reported Event|EB001|EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
11323845|NCT03347188|BG000|Baseline|Fremanezumab|Participants received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323846|NCT03347188|BG001|Baseline|Placebo|Participants received placebo matched to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323847|NCT03347188|BG002|Baseline|Total|Total of all reporting groups
11323848|NCT03347188|FG000|Participant Flow|Fremanezumab|Participants received fremanezumab 675 milligrams (mg) administered as 3 subcutaneous (SC) injections (225 mg/1.5 milliliters [mL] each) at randomization (Week 0), Weeks 4, and 8 during the double-blind (DB) treatment period. Participants who completed the DB treatment period and continued into the open-label (OL) treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323849|NCT03347188|FG001|Participant Flow|Placebo|Participants received placebo matched to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323850|NCT03347188|OG000|Outcome|Fremanezumab|Participants received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323851|NCT03347188|OG001|Outcome|Placebo|Participants received placebo matched to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323852|NCT03347188|EG000|Reported Event|Fremanezumab|Participants received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323853|NCT03347188|EG001|Reported Event|Placebo|Participants received placebo matched to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who completed the DB treatment period and continued into the OL treatment period received fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.
11323854|NCT03347279|BG000|Baseline|Tezepelumab 210mg Q4W|Tezepelumab administered every 4 weeks subcutaneously
11323855|NCT03347279|BG001|Baseline|Placebo|Placebo administered subcutaneously
11323856|NCT03347279|BG002|Baseline|Total|Total of all reporting groups
11323857|NCT03347279|FG000|Participant Flow|Tezepelumab 210mg Q4W|Tezepelumab administered every 4 weeks subcutaneously
11323858|NCT03347279|FG001|Participant Flow|Placebo|Placebo administered subcutaneously
11323859|NCT03347279|OG000|Outcome|Tezepelumab 210mg Q4W|Tezepelumab administered every 4 weeks subcutaneously
11323860|NCT03347279|OG001|Outcome|Placebo|Placebo administered subcutaneously
11323861|NCT03347279|EG000|Reported Event|Tezepelumab 210mg Q4W|Tezepelumab administered every 4 weeks subcutaneously
11323862|NCT03347279|EG001|Reported Event|Placebo|Placebo administered subcutaneously
11323863|NCT03347695|BG000|Baseline|A New Operation (Selected Pilot Study)|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323864|NCT03347695|BG001|Baseline|A New Operation|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323865|NCT03347695|BG002|Baseline|Total|Total of all reporting groups
11323866|NCT03347695|FG000|Participant Flow|A New Operation (Selected Pilot Study)|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323867|NCT03347695|FG001|Participant Flow|A New Operation|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323868|NCT03347695|OG000|Outcome|A New Operation (Selected Pilot Study)|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
11323869|NCT03347695|OG001|Outcome|A New Operation|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
11323870|NCT03347695|OG000|Outcome|A New Operation (Selected Pilot Study)|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11333495|NCT03516227|EG001|Reported Event|Control|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11333496|NCT03517436|BG000|Baseline|Edwards CENTERA System TAVR|Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
11323871|NCT03347695|OG001|Outcome|A New Operation|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323872|NCT03347695|EG000|Reported Event|A New Operation (Selected Pilot Study)|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323873|NCT03347695|EG001|Reported Event|A New Operation|"Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.~Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum."
11323874|NCT03348683|BG000|Baseline|Propranolol|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push
11323875|NCT03348683|BG001|Baseline|Placebo|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline
11323876|NCT03348683|BG002|Baseline|Total|Total of all reporting groups
11323877|NCT03348683|FG000|Participant Flow|Propranolol|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push
11323878|NCT03348683|FG001|Participant Flow|Placebo|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline
11323879|NCT03348683|OG000|Outcome|Propranolol|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push
11323880|NCT03348683|OG001|Outcome|Placebo|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline
11323881|NCT03348683|EG000|Reported Event|Propranolol|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push
11323882|NCT03348683|EG001|Reported Event|Placebo|After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline
11323883|NCT03349034|BG000|Baseline|Saline Placebo|Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323884|NCT03349034|BG001|Baseline|Ropivacaine|Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323885|NCT03349034|BG002|Baseline|Total|Total of all reporting groups
11323886|NCT03349034|FG000|Participant Flow|Saline Placebo|Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323887|NCT03349034|FG001|Participant Flow|Ropivacaine|Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323888|NCT03349034|OG000|Outcome|Saline Placebo|Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323889|NCT03349034|OG001|Outcome|Ropivacaine|Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323890|NCT03349034|OG000|Outcome|Saline Placebo|Local Saline Infusion: Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323891|NCT03349034|OG001|Outcome|Ropivacaine|Local Ropivicaine Infusion: Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323892|NCT03349034|EG000|Reported Event|Saline Placebo|Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323893|NCT03349034|EG001|Reported Event|Ropivacaine|Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
11323894|NCT03349060|BG000|Baseline|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323895|NCT03349060|BG001|Baseline|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323896|NCT03349060|BG002|Baseline|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323897|NCT03349060|BG003|Baseline|Total|Total of all reporting groups
11323898|NCT03349060|FG000|Participant Flow|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323899|NCT03349060|FG001|Participant Flow|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323900|NCT03349060|FG002|Participant Flow|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323901|NCT03349060|OG000|Outcome|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323902|NCT03349060|OG001|Outcome|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323903|NCT03349060|OG002|Outcome|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323904|NCT03349060|EG000|Reported Event|PF-04965842 100 mg|Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323905|NCT03349060|EG001|Reported Event|PF-04965842 200 mg|Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323906|NCT03349060|EG002|Reported Event|Placebo|Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
11323907|NCT03349099|BG000|Baseline|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
11323908|NCT03349099|BG001|Baseline|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
11323909|NCT03349099|BG002|Baseline|Total|Total of all reporting groups
11323910|NCT03349099|FG000|Participant Flow|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
11323911|NCT03349099|FG001|Participant Flow|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
11323912|NCT03349099|OG000|Outcome|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
11323913|NCT03349099|OG001|Outcome|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
11323914|NCT03349099|EG000|Reported Event|Cook Flexor|"ureteral access sheath~Cook Flexor: ureteral access sheath"
11323915|NCT03349099|EG001|Reported Event|Boston Scientific Navigator HD|"ureteral access sheath~Boston Scientific Navigator: ureteral access sheath"
11323916|NCT03349333|BG000|Baseline|PTCL Subtype|"Vitamin B12 and folic acid will be taken concurrently with pralatrexate~pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.~Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator."
11333497|NCT03517436|FG000|Participant Flow|Edwards CENTERA System TAVR|Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
11333498|NCT03517436|OG000|Outcome|Edwards CENTERA System TAVR|Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
11333499|NCT03517436|EG000|Reported Event|Edwards CENTERA System TAVR|Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System
11333500|NCT03517566|BG000|Baseline|Placebo|Placebo
11333501|NCT03517566|BG001|Baseline|ZPL389 3mg|ZPL389 3 mg oral powder
11323917|NCT03349333|FG000|Participant Flow|Pralatrexate|"Vitamin B12 and folic acid will be taken concurrently with pralatrexate~pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.~Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator."
11323918|NCT03349333|OG000|Outcome|Pralatrexate|"Vitamin B12 and folic acid will be taken concurrently with pralatrexate~pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.~Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator."
11323919|NCT03349333|EG000|Reported Event|Pralatrexate|"Vitamin B12 and folic acid will be taken concurrently with pralatrexate~pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.~Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator."
11323920|NCT03349437|BG000|Baseline|All Participants|All participants that were consented.
11323921|NCT03349437|FG000|Participant Flow|Participants Screened|All participants that were consented.
11323922|NCT03349437|FG001|Participant Flow|Vitabreath First, Pursed Lip Breathing Second|The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
11323923|NCT03349437|FG002|Participant Flow|Pursed Lip Breathing First, Vitabreath Second|"Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.~Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator."
11323924|NCT03349437|OG000|Outcome|Vitabreath Device|"The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.~Vitabreath Device: The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes"
11323925|NCT03349437|OG001|Outcome|Pursed Lip Breathing|"Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.~Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator."
11323926|NCT03349437|EG000|Reported Event|Participants Screened|All participants that were consented.
11323927|NCT03349437|EG001|Reported Event|Vitabreath First, Pursed Lip Breathing Second|VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support will be utilized first, followed by standard of care Pursed Lip Breathing.
11323928|NCT03349437|EG002|Reported Event|Pursed Lip Breathing First, Vitabreath Second|Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator first followed by use of Vitabreath
11323929|NCT03349515|BG000|Baseline|Group A - Povidone-iodine Ophthalmic Solution.|Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.
11323930|NCT03349515|BG001|Baseline|Group B - Ophthalmic Balanced Salt Solution.|Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
11323931|NCT03349515|BG002|Baseline|Total|Total of all reporting groups
11323932|NCT03349515|FG000|Participant Flow|Group A - Povidone-iodine Ophthalmic Solution.|"Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.~The eye drops will be administered by the study anesthesiologist."
11323933|NCT03349515|FG001|Participant Flow|Group B - Ophthalmic Balanced Salt Solution.|Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
11333502|NCT03517566|BG002|Baseline|ZPL389 10 mg|ZPL389 10 mg oral powder
11333503|NCT03517566|BG003|Baseline|ZPL389 30mg|ZPL389 30 mg oral powder
11333504|NCT03517566|BG004|Baseline|ZPL389 50mg|ZPL389 50 mg oral powder
11333505|NCT03517566|BG005|Baseline|Total|Total of all reporting groups
11333506|NCT03517566|FG000|Participant Flow|Placebo|Placebo
11323934|NCT03349515|OG000|Outcome|Group A - Povidone-iodine Ophthalmic Solution.|Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes.
11323935|NCT03349515|OG001|Outcome|Group B - Ophthalmic Balanced Salt Solution.|Group B will receive three drops in each eye of ophthalmic balanced salt solution.: Group B will receive three drops in each eye of ophthalmic balanced salt solution. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes
11323936|NCT03349515|EG000|Reported Event|Group A - Povidone-iodine Ophthalmic Solution.|Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.
11323937|NCT03349515|EG001|Reported Event|Group B - Ophthalmic Balanced Salt Solution.|Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
11323938|NCT03349567|BG000|Baseline|Patients Seen in the ED at Audit-and-feedback Sites During the Intervention Period|These measures reflect patients seen at audit-and-feedback sites during the intervention period.
11323939|NCT03349567|BG001|Baseline|Patients Seen in the ED at Control Sites During the Intervention Period|These baseline measures reflect patients seen at control sites during the intervention period.
11323940|NCT03349567|BG002|Baseline|Patients Seen in the ED at Audit-and-feedback Sites During the Baseline Period|These measures reflect patients seen at audit-and-feedback sites before the intervention period, i.e. during the baseline period.
11323941|NCT03349567|BG003|Baseline|Patients Seen in the ED at Control Sites During the Baseline Period|These measures reflect patients seen at control sites before the intervention period, i.e. during the baseline period.
11323942|NCT03349567|BG004|Baseline|Total|Total of all reporting groups
11323943|NCT03349567|FG000|Participant Flow|Audit-and-feedback|"The experimental arm will consist of 2 Emergency Departments. We will attempt to enroll all ED providers at our 2 intervention sites, and for the analysis, site-level data will be used.~Audit-and-feedback: We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter."
11323944|NCT03349567|FG001|Participant Flow|Control|The control arm will consist of 2 ED sites that do not receive the intervention. For the analysis, the control sites will be analyzed at the site-level.
11323945|NCT03349567|OG000|Outcome|Patients Seen in the ED at Audit-and-feedback Sites|All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
11323946|NCT03349567|OG001|Outcome|Patients Seen in the ED at Control Sites|All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
11323947|NCT03349567|EG000|Reported Event|Patients Seen at Audit-and-feedback ED Sites During Intervention Period|"All patients seen in the EDs undergoing the audit-and-feedback intervention will be considered to have been exposed to the intervention. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at intervention sites.~Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper."
11323948|NCT03349567|EG001|Reported Event|Patients Seen at Control ED Sites During the Intervention Period|"All patients seen in the EDs designated as control sites will be considered to have been part of the control group. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at control sites.~Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper."
11323949|NCT03349567|EG002|Reported Event|Patients Seen at Audit-and-feedback ED Sites During the Baseline Period|For this adverse event reporting section, we are only reporting ED patient-visits at intervention sites during the baseline period.
11323950|NCT03349567|EG003|Reported Event|Patients Seen at Control EDs During the Baseline Period|For this adverse event reporting section, we are reporting ED patient-visits at control sites during the baseline period.
11323951|NCT03349632|BG000|Baseline|Overall|Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11323952|NCT03349632|FG000|Participant Flow|DD T2/Oasys 1-Day (Sequence 1)|Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized
11323953|NCT03349632|FG001|Participant Flow|Oasys 1-Day/DD T2 (Sequence 2)|Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
11323954|NCT03349632|FG002|Participant Flow|DD T2/MyDay (Sequence 3)|Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
11323955|NCT03349632|FG003|Participant Flow|MyDay/DD T2 (Sequence 4)|Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
11323956|NCT03349632|FG004|Participant Flow|DD T2/Moist (Sequence 5)|Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
11323957|NCT03349632|FG005|Participant Flow|Moist/DD T2 (Sequence 6)|Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
11323958|NCT03349632|OG000|Outcome|DD T2 (Sequence 1 and 2)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323959|NCT03349632|OG001|Outcome|Oasys 1-Day (Sequence 1 and 2)|Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323960|NCT03349632|OG002|Outcome|DD T2 (Sequence 3 and 4)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323961|NCT03349632|OG003|Outcome|MyDay (Sequence 3 and 4)|Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323962|NCT03349632|OG004|Outcome|DD T2 (Sequence 5 and 6)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323963|NCT03349632|OG005|Outcome|Moist (Sequence 5 and 6)|Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323964|NCT03349632|EG000|Reported Event|DD T2 (Sequence 1 and 2)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323965|NCT03349632|EG001|Reported Event|Oasys 1- Day (Sequence 1 and 2)|Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323966|NCT03349632|EG002|Reported Event|DD T2 (Sequence 3 and 4)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323967|NCT03349632|EG003|Reported Event|MyDay (Sequence 3 and 4)|Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323968|NCT03349632|EG004|Reported Event|DD T2 (Sequence 5 and 6)|Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323969|NCT03349632|EG005|Reported Event|Moist (Sequence 5 and 6)|Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
11323970|NCT03349710|BG000|Baseline|Arm A (Cohort 1)|Nivolumab + Radiotherapy
11323971|NCT03349710|BG001|Baseline|Arm B (Cohort 1)|Cetuximab + Radiotherapy
11323972|NCT03349710|BG002|Baseline|Arm C (Cohort 2)|Cisplatin + Nivolumab + Radiotherapy
11323973|NCT03349710|BG003|Baseline|Arm D (Cohort 2)|Cisplatin + Radiotherapy
11323974|NCT03349710|BG004|Baseline|Total|Total of all reporting groups
11323975|NCT03349710|FG000|Participant Flow|Arm A (Cohort 1)|Nivolumab + Radiotherapy
11323976|NCT03349710|FG001|Participant Flow|Arm B (Cohort 1)|Cetuximab + Radiotherapy
11323977|NCT03349710|FG002|Participant Flow|Arm C (Cohort 2)|Cisplatin + Nivolumab + Radiotherapy
11323978|NCT03349710|FG003|Participant Flow|Arm D (Cohort 2)|Cisplatin + Radiotherapy
11323979|NCT03349710|OG000|Outcome|Arm A (Cohort 1)|Nivolumab + Radiotherapy
11323980|NCT03349710|OG001|Outcome|Arm B (Cohort 1)|Cetuximab + Radiotherapy
11323981|NCT03349710|OG002|Outcome|Arm C (Cohort 2)|Cisplatin + Nivolumab + Radiotherapy
11323982|NCT03349710|OG003|Outcome|Arm D (Cohort 2)|Cisplatin + Radiotherapy
11323983|NCT03349710|EG000|Reported Event|Arm A (Cohort 1)|Nivolumab + Radiotherapy
11323984|NCT03349710|EG001|Reported Event|Arm B (Cohort 1)|Cetuximab + Radiotherapy
11323985|NCT03349710|EG002|Reported Event|Arm C (Cohort 2)|Cisplatin + Nivolumab + Radiotherapy
11323986|NCT03349710|EG003|Reported Event|Arm D (Cohort 2)|Cisplatin + Radiotherapy
11323987|NCT03349892|BG000|Baseline|Stereotactic Ablation Treatment Arm|"This is a single-arm, non-blinded study.~Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning."
11323988|NCT03349892|FG000|Participant Flow|Stereotactic Ablation Treatment Arm|"This is a single-arm, non-blinded study.~Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning."
11323989|NCT03349892|OG000|Outcome|Stereotactic Ablation Treatment Arm|"This is a single-arm, non-blinded study.~Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning."
11323990|NCT03349892|EG000|Reported Event|Stereotactic Ablation Treatment Arm|"This is a single-arm, non-blinded study.~Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning."
11323991|NCT03350217|BG000|Baseline|Eleview|"This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323992|NCT03350217|BG001|Baseline|Hetastarch|"This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323993|NCT03350217|BG002|Baseline|Total|Total of all reporting groups
11333507|NCT03517566|FG001|Participant Flow|ZPL389 3mg|ZPL389 3 mg oral powder
11323994|NCT03350217|FG000|Participant Flow|Eleview|"This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323995|NCT03350217|FG001|Participant Flow|Hetastarch|"This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323996|NCT03350217|OG000|Outcome|Eleview|"This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323997|NCT03350217|OG001|Outcome|Hetastarch|"This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323998|NCT03350217|EG000|Reported Event|Eleview|"This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11323999|NCT03350217|EG001|Reported Event|Hetastarch|"This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.~Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion."
11324000|NCT03350256|BG000|Baseline|Microdosing Group|"Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.~Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients."
11324001|NCT03350256|FG000|Participant Flow|Microdosing Group|"Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.~Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients."
11324002|NCT03350256|OG000|Outcome|Microdosing Group|"Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.~Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients."
11324003|NCT03350256|EG000|Reported Event|Microdosing Group|"Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.~Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients."
11324004|NCT03350542|BG000|Baseline|SYNERGY 48mm|SYNERGY is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
11324005|NCT03350542|FG000|Participant Flow|SYNERGY 48 mm|"SYNERGY 48 mm is a device/ drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating)~SYNERGY 48 mm: A drug eluting coronary stent system"
11324006|NCT03350542|OG000|Outcome|SYNERGY 48 mm|"SYNERGY 48 mm is a device/ drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating)~SYNERGY 48 mm: A drug eluting coronary stent system"
11324007|NCT03350542|EG000|Reported Event|SYNERGY 48 mm|"SYNERGY 48 mm is a device/ drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating)~SYNERGY 48 mm: A drug eluting coronary stent system"
11324008|NCT03350672|BG000|Baseline|Cohort 2|Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence
11324009|NCT03350672|BG001|Baseline|Cohort 1b|HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
11324010|NCT03350672|BG002|Baseline|Cohort 1a|HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
11324011|NCT03350672|BG003|Baseline|Total|Total of all reporting groups
11324012|NCT03350672|FG000|Participant Flow|Cohort 2|Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence
11324013|NCT03350672|FG001|Participant Flow|Cohort 1a|HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
11333508|NCT03517566|FG002|Participant Flow|ZPL389 10 mg|ZPL389 10 mg oral powder
11333509|NCT03517566|FG003|Participant Flow|ZPL389 30mg|ZPL389 30 mg oral powder
11333510|NCT03517566|FG004|Participant Flow|ZPL389 50mg|ZPL389 50 mg oral powder
11333511|NCT03517566|OG000|Outcome|Placebo|Placebo
11333512|NCT03517566|OG001|Outcome|ZPL389 3mg|ZPL389 3 mg oral powder
11324014|NCT03350672|FG002|Participant Flow|Cohort 1b|HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
11324015|NCT03350672|OG000|Outcome|Cohort 1b|HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
11324016|NCT03350672|OG000|Outcome|Cohort 1a|HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
11324017|NCT03350672|OG000|Outcome|Cohort 2|Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence
11324018|NCT03350672|EG000|Reported Event|Cohort 2|Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence
11324019|NCT03350672|EG001|Reported Event|Cohort 1b|HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
11324020|NCT03350672|EG002|Reported Event|Cohort 1a|HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
11324021|NCT03350724|BG000|Baseline|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
11324022|NCT03350724|BG001|Baseline|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
11324023|NCT03350724|BG002|Baseline|Total|Total of all reporting groups
11324024|NCT03350724|FG000|Participant Flow|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
11324025|NCT03350724|FG001|Participant Flow|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
11324026|NCT03350724|OG000|Outcome|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
11324027|NCT03350724|OG001|Outcome|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
11324028|NCT03350724|EG000|Reported Event|Episil Wound Dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
11324029|NCT03350724|EG001|Reported Event|PeriAcryl90 Wound Dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
11324030|NCT03350919|BG000|Baseline|Training in the Blind Field|"Training in the blind field using software~Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324031|NCT03350919|BG001|Baseline|Training in the Intact Field|"Training in the intact field using software~Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324032|NCT03350919|BG002|Baseline|Total|Total of all reporting groups
11324033|NCT03350919|FG000|Participant Flow|Training in the Blind Field|"Training in the blind field using software~Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324034|NCT03350919|FG001|Participant Flow|Training in the Intact Field|"Training in the intact field using software~Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324035|NCT03350919|OG000|Outcome|Training in the Blind Field (Left Eye)|"Training in the blind field using software~Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.~Final outcomes will be reported independently for Left and Right eyes."
11333513|NCT03517566|OG002|Outcome|ZPL389 10 mg|ZPL389 10 mg oral powder
11333514|NCT03517566|OG003|Outcome|ZPL389 30mg|ZPL389 30 mg oral powder
11333515|NCT03517566|OG004|Outcome|ZPL389 50mg|ZPL389 50 mg oral powder
11333516|NCT03517566|EG000|Reported Event|Placebo|Placebo
11324036|NCT03350919|OG001|Outcome|Training in the Intact Field (Left Eye)|"Training in the intact field using software~Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.~Final outcomes will be reported independently for Left and Right eyes."
11324037|NCT03350919|OG002|Outcome|Training in the Blind Field (Right Eye)|"Training in the blind field using software~Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.~Final outcomes will be reported independently for Left and Right eyes."
11324038|NCT03350919|OG003|Outcome|Training in the Intact Field (Right Eye)|"Training in the intact field using software~Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.~Final outcomes will be reported independently for Left and Right eyes."
11324039|NCT03350919|EG000|Reported Event|Training in the Blind Field|"Training in the blind field using software~Training in the blind field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324040|NCT03350919|EG001|Reported Event|Training in the Intact Field|"Training in the intact field using software~Training in the intact field: A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks."
11324041|NCT03351101|BG000|Baseline|Senofilcon C|"Senofilcon C Contact Lens~Senofilcon C: Senofilcon C Contact Lens"
11324042|NCT03351101|BG001|Baseline|Samfilcon A|"Samfilcon A Contact Lens~Samfilcon A: Samfilcon A Contact Lens"
11324043|NCT03351101|BG002|Baseline|Total|Total of all reporting groups
11324044|NCT03351101|FG000|Participant Flow|Senofilcon C|"Senofilcon C Contact Lens~Senofilcon C: Senofilcon C Contact Lens"
11324045|NCT03351101|FG001|Participant Flow|Samfilcon A|"Samfilcon A Contact Lens~Samfilcon A: Samfilcon A Contact Lens"
11324046|NCT03351101|OG000|Outcome|Senofilcon C|"Senofilcon C Contact Lens~Senofilcon C: Senofilcon C Contact Lens"
11324047|NCT03351101|OG001|Outcome|Samfilcon A|"Samfilcon A Contact Lens~Samfilcon A: Samfilcon A Contact Lens"
11324048|NCT03351101|EG000|Reported Event|Senofilcon C|"Senofilcon C Contact Lens~Senofilcon C: Senofilcon C Contact Lens"
11324049|NCT03351101|EG001|Reported Event|Samfilcon A|"Samfilcon A Contact Lens~Samfilcon A: Samfilcon A Contact Lens"
11324050|NCT03351114|BG000|Baseline|Crisaborole 2% Ointment|"Crisaborole 2% ointment applied to affected skin twice per day.~Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day."
11324051|NCT03351114|FG000|Participant Flow|Crisaborole 2% Ointment|"Crisaborole 2% ointment applied to affected skin twice per day.~Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day."
11324052|NCT03351114|OG000|Outcome|Crisaborole 2% Ointment|"Crisaborole 2% ointment applied to affected skin twice per day.~Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day."
11324053|NCT03351114|EG000|Reported Event|Crisaborole 2% Ointment|"Crisaborole 2% ointment applied to affected skin twice per day.~Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day."
11324054|NCT03351231|BG000|Baseline|BMS-986242 12.5 mg + Nivolumab 480 mg|2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
11324055|NCT03351231|FG000|Participant Flow|BMS-986242 12.5 mg + Nivolumab 480 mg|2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
11324056|NCT03351231|OG000|Outcome|BMS-986242 12.5 mg + Nivolumab 480 mg|2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
11333517|NCT03517566|EG001|Reported Event|ZPL389 3 mg|ZPL389 3 mg oral powder
11333518|NCT03517566|EG002|Reported Event|ZPL389 10 mg|ZPL389 10 mg oral powder
11324057|NCT03351231|EG000|Reported Event|BMS-986242 12.5 mg + Nivolumab 480 mg|2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
11324058|NCT03351335|BG000|Baseline|Group EL 2: Ultherapy|Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
11324059|NCT03351335|BG001|Baseline|Group EL 3: Ultherapy|Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
11324060|NCT03351335|BG002|Baseline|Group EL 4: Ultherapy|Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
11324061|NCT03351335|BG003|Baseline|Total|Total of all reporting groups
11324062|NCT03351335|FG000|Participant Flow|Group EL 2: Ultherapy|Participants received a single Ultherapy treatment at energy level 2 (EL2) on the lower face, submental (under the chin) and neck area at dual depth using transducer DeepSEE (DS) 4 to 4.5 with treatment frequency 4 megahertz (MHz) and depth 4.5 millimeter (mm) at energy level 0.90 Joule (J), and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
11324063|NCT03351335|FG001|Participant Flow|Group EL 3: Ultherapy|Participants received a single Ultherapy treatment at energy level 3 (EL3) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
11324064|NCT03351335|FG002|Participant Flow|Group EL 4: Ultherapy|Participants received a single Ultherapy treatment at energy level 4 (EL4) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
11324065|NCT03351335|OG000|Outcome|Group EL 2: Ultherapy|Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
11324066|NCT03351335|OG001|Outcome|Group EL 3: Ultherapy|Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
11324067|NCT03351335|OG002|Outcome|Group EL 4: Ultherapy|Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
11324068|NCT03351335|EG000|Reported Event|Group EL 2: Ultherapy|Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
11324069|NCT03351335|EG001|Reported Event|Group EL 3: Ultherapy|Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
11324070|NCT03351335|EG002|Reported Event|Group EL 4: Ultherapy|Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
11324071|NCT03351478|BG000|Baseline|Sotagliflozin 400 mg|Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
11324072|NCT03351478|BG001|Baseline|Empagliflozin 25 mg|Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
11324073|NCT03351478|BG002|Baseline|Placebo|Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
11324074|NCT03351478|BG003|Baseline|Total|Total of all reporting groups
11324075|NCT03351478|FG000|Participant Flow|Sotagliflozin 400 mg|Following a 2-week run-in period, sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
11324076|NCT03351478|FG001|Participant Flow|Empagliflozin 25 mg|Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
11324077|NCT03351478|FG002|Participant Flow|Placebo|Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
11333519|NCT03517566|EG003|Reported Event|ZPL389 30 mg|ZPL389 30 mg oral powder
11324078|NCT03351478|OG000|Outcome|Sotagliflozin 400 mg|Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
11324079|NCT03351478|OG001|Outcome|Empagliflozin 25 mg|Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
11324080|NCT03351478|OG002|Outcome|Placebo|Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
11324081|NCT03351478|EG000|Reported Event|Sotagliflozin 400 mg|Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
11324082|NCT03351478|EG001|Reported Event|Empagliflozin 25 mg|Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
11324083|NCT03351478|EG002|Reported Event|Placebo|Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
11324084|NCT03351608|BG000|Baseline|Part A: Sugammadex 2 mg/kg|For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) is given after the final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324085|NCT03351608|BG001|Baseline|Part A: Sugammadex 4 mg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324086|NCT03351608|BG002|Baseline|Part B: Sugammadex 2 mg/kg|For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) is given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324087|NCT03351608|BG003|Baseline|Part B: Sugammadex 4 mg/kg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324088|NCT03351608|BG004|Baseline|Part B: Neostigmine + (Glycopyrrolate or Atropine)|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324089|NCT03351608|BG005|Baseline|Total|Total of all reporting groups
11324090|NCT03351608|FG000|Participant Flow|Part A: Sugammadex 2 mg/kg|For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.
11324091|NCT03351608|FG001|Participant Flow|Part A: Sugammadex 4 mg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324092|NCT03351608|FG002|Participant Flow|Part B: Sugammadex 2 mg/kg|For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324093|NCT03351608|FG003|Participant Flow|Part B: Sugammadex 4 mg/kg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324094|NCT03351608|FG004|Participant Flow|Part B: Neostigmine + (Glycopyrrolate or Atropine)|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324095|NCT03351608|OG000|Outcome|Part A: Sugammadex 2 mg (2 to <6 Years)|Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
11324096|NCT03351608|OG001|Outcome|Part A: Sugammadex 2 mg (6 to <12 Years)|Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
11324097|NCT03351608|OG002|Outcome|Part A: Sugammadex 2 mg (12 to <17 Years)|Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
11324098|NCT03351608|OG003|Outcome|Part A: Sugammadex 4 mg (2 to <6 Years)|Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.
11324099|NCT03351608|OG004|Outcome|Part A: Sugammadex 4 mg (6 to <12 Years)|Participants in Part A receiving sugammadex 4 mg and who are 6 to <12 years of age are included.
11324100|NCT03351608|OG005|Outcome|Part A: Sugammadex 4 mg (12 to <17 Years)|Participants in Part A receiving sugammadex 4 mg and who are 12 to <17 years of age are included.
11324101|NCT03351608|OG000|Outcome|Part B: Neostigmine + (Glycopyrrolate or Atropine)|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324102|NCT03351608|OG001|Outcome|Parts A and B: Sugammadex 2 mg|All participants in Parts A and B who received sugammadex 2 mg are included in the analysis.
11324103|NCT03351608|OG002|Outcome|Parts A and B: Sugammadex 4 mg|All participants in Parts A and B who received sugammadex 4 mg are included in the analysis.
11333520|NCT03517566|EG004|Reported Event|ZPL389 50 mg|ZPL389 50 mg oral powder
11333521|NCT03517566|EG005|Reported Event|All Patients|All Patients
11324104|NCT03351608|OG000|Outcome|Part B: Sugammadex 2 mg/kg|For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324105|NCT03351608|OG001|Outcome|Part B: Sugammadex 4 mg/kg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324106|NCT03351608|OG002|Outcome|Part B: Neostigmine + (Glycopyrrolate or Atropine)|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324107|NCT03351608|EG000|Reported Event|Part A: Sugammadex 2 mg (2 to <6 Years)|Participants in Part A receiving sugammadex 2 mg and who are 2 to <6 years of age are included.
11324108|NCT03351608|EG001|Reported Event|Part A: Sugammadex 2 mg (6 to <12 Years)|Participants in Part A receiving sugammadex 2 mg and who are 6 to <12 years of age are included.
11324109|NCT03351608|EG002|Reported Event|Part A: Sugammadex 2 mg (12 to <17 Years)|Participants in Part A receiving sugammadex 2 mg and who are 12 to <17 years of age are included.
11324110|NCT03351608|EG003|Reported Event|Part A: Sugammadex 4 mg (2 to <6 Years)|Participants in Part A receiving sugammadex 4 mg and who are 2 to <6 years of age are included.
11324111|NCT03351608|EG004|Reported Event|Part A: Sugammadex 4 mg (6 to <12 Years)|Participants in Part A receiving sugammadex 4 mg and who are 6 to <12 years of age are included.
11324112|NCT03351608|EG005|Reported Event|Part A: Sugammadex 4 mg (12 to <17 Years)|Participants in Part A receiving sugammadex 4 mg and who are 12 to <17 years of age are included.
11324113|NCT03351608|EG006|Reported Event|Part B: Sugammadex 2 mg|For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324114|NCT03351608|EG007|Reported Event|Part B: Sugammadex 4 mg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
11324115|NCT03351608|EG008|Reported Event|Part B: Neostigmine + (Glycopyrrolate or Atropine)|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
11324116|NCT03351699|BG000|Baseline|Panel A: MK-4250 150 mg|Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast.
11324117|NCT03351699|BG001|Baseline|Panel B: MK-4250 600 mg|Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A.
11324118|NCT03351699|BG002|Baseline|Panel D: MK-4250 900 mg|Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels.
11324119|NCT03351699|BG003|Baseline|Panel E: MK-4250 ≤900 mg With a Low-fat Meal|Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel.
11324120|NCT03351699|BG004|Baseline|Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal|Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E.
11324121|NCT03351699|BG005|Baseline|Total|Total of all reporting groups
11324122|NCT03351699|FG000|Participant Flow|Panel A: MK-4250 150 mg|Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast.
11324123|NCT03351699|FG001|Participant Flow|Panel B: MK-4250 600 mg|Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A.
11324124|NCT03351699|FG002|Participant Flow|Panel D: MK-4250 900 mg|Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels.
11324125|NCT03351699|FG003|Participant Flow|Panel E: MK-4250 ≤900 mg With a Low-fat Meal|Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel.
11324126|NCT03351699|FG004|Participant Flow|Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal|Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E.
11324127|NCT03351699|OG000|Outcome|Panel A: MK-4250 150 mg|Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast.
11324128|NCT03351699|OG001|Outcome|Panel B: MK-4250 600 mg|Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A.
11324129|NCT03351699|OG002|Outcome|Panel D: MK-4250 900 mg|Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels.
11324130|NCT03351699|OG003|Outcome|Panel E: MK-4250 ≤900 mg With a Low-fat Meal|Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel.
11333522|NCT03518008|BG000|Baseline|Overall|Verofilcon A and somofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11324131|NCT03351699|OG004|Outcome|Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal|Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E.
11324132|NCT03351699|OG000|Outcome|Screening|This arm is all participants from all treatment arms, analyzed during the period prior to receipt of any study intervention.
11324133|NCT03351699|OG001|Outcome|Panel A: MK-4250 150 mg|Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast.
11324134|NCT03351699|OG002|Outcome|Panel B: MK-4250 600 mg|Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A.
11324135|NCT03351699|OG003|Outcome|Panel D: MK-4250 900 mg|Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels.
11324136|NCT03351699|OG004|Outcome|Panel E: MK-4250 ≤900 mg With a Low-fat Meal|Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel.
11324137|NCT03351699|OG005|Outcome|Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal|Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E.
11324138|NCT03351699|EG000|Reported Event|Screening|This group represents all participants during their individual screening phase, approximately 4 weeks prior to first dose. No intervention was provided during this time.
11324139|NCT03351699|EG001|Reported Event|Panel A: 150 mg MK-4250|Participants received MK-4250 150 mg tablet by mouth on Day 1 after an 8-hour fast.
11324140|NCT03351699|EG002|Reported Event|Panel B: 600 mg MK-4250|Participants received MK-4250 600 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A.
11324141|NCT03351699|EG003|Reported Event|Panel D: 900 mg MK-4250|Participants received MK-4250 900 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels.
11324142|NCT03351699|EG004|Reported Event|Panel E: 900 mg MK-4250, With a Low Fat Meal|Participants received MK-4250 ≤900 mg tablet by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel.
11324143|NCT03351738|BG000|Baseline|Placebo|Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
11324144|NCT03351738|BG001|Baseline|MEDI5884 50 mg|Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
11324145|NCT03351738|BG002|Baseline|MEDI5884 100 mg|Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
11324146|NCT03351738|BG003|Baseline|MEDI5884 200 mg|Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
11324147|NCT03351738|BG004|Baseline|MEDI5884 350 mg|Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
11324148|NCT03351738|BG005|Baseline|MEDI5884 500 mg|Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
11324149|NCT03351738|BG006|Baseline|Total|Total of all reporting groups
11324150|NCT03351738|FG000|Participant Flow|Placebo|Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
11324151|NCT03351738|FG001|Participant Flow|MEDI5884 50 mg|Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
11324152|NCT03351738|FG002|Participant Flow|MEDI5884 100 mg|Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
11324153|NCT03351738|FG003|Participant Flow|MEDI5884 200 mg|Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
11324154|NCT03351738|FG004|Participant Flow|MEDI5884 350 mg|Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
11324155|NCT03351738|FG005|Participant Flow|MEDI5884 500 mg|Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
11324156|NCT03351738|OG000|Outcome|Placebo|Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
11324157|NCT03351738|OG001|Outcome|MEDI5884 50 mg|Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
11324158|NCT03351738|OG002|Outcome|MEDI5884 100 mg|Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
11324159|NCT03351738|OG003|Outcome|MEDI5884 200 mg|Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
11324160|NCT03351738|OG004|Outcome|MEDI5884 350 mg|Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
11324161|NCT03351738|OG005|Outcome|MEDI5884 500 mg|Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
11324162|NCT03351738|OG000|Outcome|MEDI5884 50 mg|Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
11324163|NCT03351738|OG001|Outcome|MEDI5884 100 mg|Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
11324164|NCT03351738|OG002|Outcome|MEDI5884 200 mg|Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
11324165|NCT03351738|OG003|Outcome|MEDI5884 350 mg|Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
11324166|NCT03351738|OG004|Outcome|MEDI5884 500 mg|Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
11324167|NCT03351738|EG000|Reported Event|Placebo|Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
11324168|NCT03351738|EG001|Reported Event|MEDI5884 50 mg|Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
11324169|NCT03351738|EG002|Reported Event|MEDI5884 100 mg|Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
11324170|NCT03351738|EG003|Reported Event|MEDI5884 200 mg|Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
11324171|NCT03351738|EG004|Reported Event|MEDI5884 350 mg|Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
11324172|NCT03351738|EG005|Reported Event|MEDI5884 500 mg|Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
11324173|NCT03351933|BG000|Baseline|Immune Globulin (Human) GamaSTAN|"The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days.~Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects."
11324174|NCT03351933|FG000|Participant Flow|Immune Globulin (Human) GamaSTAN|"The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days.~Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects."
11324175|NCT03351933|OG000|Outcome|Immune Globulin (Human) GamaSTAN|"The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days.~Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects."
11324176|NCT03351933|EG000|Reported Event|Immune Globulin (Human) GamaSTAN|"The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days.~Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects."
11324177|NCT03352245|BG000|Baseline|Intervention Group|"Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).~Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)"
11324178|NCT03352245|BG001|Baseline|Control Group|Usual care group will receive standard of care management from their Oncologist.
11324179|NCT03352245|BG002|Baseline|Total|Total of all reporting groups
11324180|NCT03352245|FG000|Participant Flow|Intervention Group|"Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).~Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)"
11324181|NCT03352245|FG001|Participant Flow|Control Group|Usual care group will receive standard of care management from their Oncologist.
11324182|NCT03352245|OG000|Outcome|Intervention Group|"Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).~Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)"
11324183|NCT03352245|OG001|Outcome|Control Group|Usual care group will receive standard of care management from their Oncologist.
11324184|NCT03352245|EG000|Reported Event|Intervention Group|"Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).~Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)"
11324185|NCT03352245|EG001|Reported Event|Control Group|Usual care group will receive standard of care management from their Oncologist.
11324186|NCT03352323|BG000|Baseline|Oxymetazoline Cream|Rhofade cream
11324187|NCT03352323|FG000|Participant Flow|Oxymetazoline Cream|Rhofade cream
11324188|NCT03352323|OG000|Outcome|Oxymetazoline Cream|Rhofade cream
11324189|NCT03352323|EG000|Reported Event|Oxymetazoline Cream|Rhofade cream
11324190|NCT03352414|BG000|Baseline|Alvimopan|Alvimpan Arm
11324191|NCT03352414|BG001|Baseline|Placebo|Placebo Arm
11324192|NCT03352414|BG002|Baseline|Total|Total of all reporting groups
11324193|NCT03352414|FG000|Participant Flow|Alvimopan|Alvimopan: alvimopan pill
11324194|NCT03352414|FG001|Participant Flow|Placebo|Placebo: placebo pill
11324195|NCT03352414|OG000|Outcome|Alvimopan|Alvimopan: alvimopan pill
11324196|NCT03352414|OG001|Outcome|Placebo|Placebo: placebo pill
11324197|NCT03352414|OG000|Outcome|Alvimopan|Alvimpan Arm
11324198|NCT03352414|OG001|Outcome|Placebo|Placebo Arm
11324199|NCT03352414|EG000|Reported Event|Alvimopan|Alvimopan: alvimopan pill
11324200|NCT03352414|EG001|Reported Event|Placebo|Placebo: placebo pill
11324201|NCT03352453|BG000|Baseline|Placebo|Placebo-matching rapastinel weekly IV injections.
11324202|NCT03352453|BG001|Baseline|Rapastinel 450mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
11324203|NCT03352453|BG002|Baseline|Total|Total of all reporting groups
11324204|NCT03352453|FG000|Participant Flow|Placebo|Placebo-matching rapastinel weekly IV injections.
11324205|NCT03352453|FG001|Participant Flow|Rapastinel 450mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
11324206|NCT03352453|OG000|Outcome|Placebo|Placebo-matching rapastinel weekly IV injections.
11324207|NCT03352453|OG001|Outcome|Rapastinel 450mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
11324208|NCT03352453|EG000|Reported Event|Placebo|Placebo-matching rapastinel weekly IV injections.
11324209|NCT03352453|EG001|Reported Event|Rapastinel 450mg|Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
11324210|NCT03352609|BG000|Baseline|Active rTMS|"5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.~Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session."
11324211|NCT03352609|BG001|Baseline|Sham|"5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.~Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads"
11324212|NCT03352609|BG002|Baseline|Total|Total of all reporting groups
11324213|NCT03352609|FG000|Participant Flow|Active rTMS|"5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.~Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session."
11324214|NCT03352609|FG001|Participant Flow|Sham|"5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.~Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads"
11324215|NCT03352609|OG000|Outcome|Active rTMS|"5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.~Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session."
11324216|NCT03352609|OG001|Outcome|Sham|"5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.~Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads"
11324217|NCT03352609|EG000|Reported Event|Active rTMS|"5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.~Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session."
11324218|NCT03352609|EG001|Reported Event|Sham|"5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.~Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads"
11324219|NCT03352713|BG000|Baseline|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11324220|NCT03352713|FG000|Participant Flow|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11324221|NCT03352713|OG000|Outcome|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11324222|NCT03352713|EG000|Reported Event|Laddr|"All participants in the study will be invited to use Laddr, described in the intervention section.~Laddr: Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
11324223|NCT03353220|BG000|Baseline|Arm A+B (All Participants)|"Phase 1: Participants either receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period then cross over to receive placebo twice a day for 7 days (Arm A) OR receive placebo twice a day for 7 days followed by a 3 week washout period then cross over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days (Arm B).~Phase 2: Participants (from both arms) will receive additional lorcaserin (Belviq) for 24 weeks.~Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.~Belviq: Belviq is an oral drug~Placebo: The placebo is made to mimic Belviq, but does not contain any active drug"
11324224|NCT03353220|FG000|Participant Flow|Arm A (LOR-Placebo-LOR)|"Phase 1: Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days.~Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks.~Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug."
11324225|NCT03353220|FG001|Participant Flow|Arm B (Placebo-LOR-LOR)|"Phase 1: Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days.~Phase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks.~Belviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug."
11324226|NCT03353220|OG000|Outcome|Placebo|"Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.~Placebo: The placebo is made to mimic Belviq, but does not contain any active drug."
11324227|NCT03353220|OG001|Outcome|Lorcaserin|"Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.~Belviq: Belviq is an oral drug."
11324228|NCT03353220|EG000|Reported Event|LOR Time Period|"Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.~Belviq: Belviq is an oral drug."
11324229|NCT03353220|EG001|Reported Event|Placebo Time Period|"Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.~Placebo: The placebo is made to mimic Belviq, but does not contain any active drug."
11324230|NCT03353246|BG000|Baseline|InfraScanner 2000™|"All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.~InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention."
11324231|NCT03353246|FG000|Participant Flow|InfraScanner 2000™|"All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.~InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention."
11324232|NCT03353246|OG000|Outcome|InfraScanner 2000™|"All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.~InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention."
11324233|NCT03353246|EG000|Reported Event|InfraScanner 2000™|"All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.~InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention."
11324234|NCT03353740|BG000|Baseline|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11324235|NCT03353740|FG000|Participant Flow|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11324236|NCT03353740|OG000|Outcome|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11324237|NCT03353740|EG000|Reported Event|Ga-68 Labeled PSMA-11 PET|"PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.~Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol."
11324238|NCT03353753|BG000|Baseline|Ripretinib|Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
11324239|NCT03353753|BG001|Baseline|Placebo|Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
11324240|NCT03353753|BG002|Baseline|Total|Total of all reporting groups
11324241|NCT03353753|FG000|Participant Flow|Ripretinib|Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
11333523|NCT03518008|FG000|Participant Flow|DDT2, Then Clariti 1 Day|Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product will be worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
10827875|NCT00112242|FG003|Participant Flow|4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676"
10827876|NCT00112242|FG004|Participant Flow|5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2"
10827877|NCT00112242|OG000|Outcome|1.Melan-A ELA|500 mcg Melan-A ELA analog peptide + 1 ml Montanide
10827878|NCT00112242|OG001|Outcome|2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
10827879|NCT00112242|OG002|Outcome|3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
10827880|NCT00112242|OG003|Outcome|4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676"
10827881|NCT00112242|OG004|Outcome|5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2"
10827882|NCT00112242|OG000|Outcome|1. Melan-A ELA|500 mcg Melan-A ELA analog peptide + 1 ml Montanide
10827883|NCT00112242|OG001|Outcome|2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b (A) analog peptide + 500 mcg Mage-A10 peptide + 1 ml Montanide
10827884|NCT00112242|OG002|Outcome|3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG|500 mcg Melan-A ELA analog peptide, 500 mcg + NY-ESO-1b(A) analog peptide + 500 mcg Mage-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
10827885|NCT00112242|OG003|Outcome|4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676"
10827886|NCT00112242|OG004|Outcome|5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2"
10827887|NCT00112242|OG001|Outcome|2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
10827888|NCT00112242|OG002|Outcome|3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
10827889|NCT00112242|OG004|Outcome|Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2"
10827890|NCT00112242|EG000|Reported Event|1. Melan-A ELA|500 mcg Melan-A ELA analog peptide + 1 ml Montanide
10827891|NCT00112242|EG001|Reported Event|2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
10827892|NCT00112242|EG002|Reported Event|3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG|500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
10827893|NCT00112242|EG003|Reported Event|4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676"
11324242|NCT03353753|FG001|Participant Flow|Placebo|Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
11324243|NCT03353753|OG000|Outcome|Ripretinib|Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
11324244|NCT03353753|OG001|Outcome|Placebo|Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
11324245|NCT03353753|EG000|Reported Event|Ripretinib|Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
11324246|NCT03353753|EG001|Reported Event|Placebo|Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
11324247|NCT03354325|BG000|Baseline|Scheduled PCP Follow-up|"Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.~Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge."
11324248|NCT03354325|BG001|Baseline|As Needed PCP Follow-up|"At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.~As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise."
11324249|NCT03354325|BG002|Baseline|Total|Total of all reporting groups
11324250|NCT03354325|FG000|Participant Flow|Scheduled PCP Follow-up|"Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.~Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge."
11324251|NCT03354325|FG001|Participant Flow|As Needed PCP Follow-up|"At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.~As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise."
11324252|NCT03354325|OG000|Outcome|Scheduled PCP Follow-up|"Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.~Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge."
11324253|NCT03354325|OG001|Outcome|As Needed PCP Follow-up|"At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.~As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise."
11324254|NCT03354325|EG000|Reported Event|Scheduled PCP Follow-up|"Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.~Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge."
11324255|NCT03354325|EG001|Reported Event|As Needed PCP Follow-up|"At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.~As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise."
11324256|NCT03354429|BG000|Baseline|TICAGRELOR|Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
11324257|NCT03354429|BG001|Baseline|PLACEBO|Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
11324258|NCT03354429|BG002|Baseline|Total|Total of all reporting groups
11324259|NCT03354429|FG000|Participant Flow|TICAGRELOR|Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
11324260|NCT03354429|FG001|Participant Flow|PLACEBO|Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
11324261|NCT03354429|OG000|Outcome|TICAGRELOR|Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
11324262|NCT03354429|OG001|Outcome|PLACEBO|Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
11324263|NCT03354429|EG000|Reported Event|Ticagrelor|Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
11324264|NCT03354429|EG001|Reported Event|Placebo|Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
11324265|NCT03354598|BG000|Baseline|Sulopenem-etzadroxil/Probenecid|"Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days~Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection"
11324266|NCT03354598|BG001|Baseline|Ciprofloxacin|"Ciprofloxacin 250 mg PO administered twice daily for 3 days~Ciprofloxacin: Treatment of uncomplicated urinary tract infection"
11324267|NCT03354598|BG002|Baseline|Total|Total of all reporting groups
11324268|NCT03354598|FG000|Participant Flow|Sulopenem-etzadroxil/Probenecid|"Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days~Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection"
11324269|NCT03354598|FG001|Participant Flow|Ciprofloxacin|"Ciprofloxacin 250 mg PO administered twice daily for 3 days~Ciprofloxacin: Treatment of uncomplicated urinary tract infection"
11324270|NCT03354598|OG000|Outcome|Sulopenem-etzadroxil/Probenecid|"Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days~Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection"
11324271|NCT03354598|OG001|Outcome|Ciprofloxacin|"Ciprofloxacin 250 mg PO administered twice daily for 3 days~Ciprofloxacin: Treatment of uncomplicated urinary tract infection"
11324272|NCT03354598|EG000|Reported Event|Sulopenem-etzadroxil/Probenecid|"Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days~Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection"
11324273|NCT03354598|EG001|Reported Event|Ciprofloxacin|"Ciprofloxacin 250 mg PO administered twice daily for 3 days~Ciprofloxacin: Treatment of uncomplicated urinary tract infection"
11324274|NCT03354637|BG000|Baseline|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily.
11324275|NCT03354637|BG001|Baseline|ATI-50002 0.12% Topical Solution|ATI-50002 0.12% Topical Solution applied twice daily.
11324276|NCT03354637|BG002|Baseline|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily.
11324277|NCT03354637|BG003|Baseline|Total|Total of all reporting groups
11324278|NCT03354637|FG000|Participant Flow|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily.
11324279|NCT03354637|FG001|Participant Flow|ATI-50002 0.12% Topical Solution|ATI-50002 0.12% Topical Solution applied twice daily.
11324280|NCT03354637|FG002|Participant Flow|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily.
11324281|NCT03354637|OG000|Outcome|Vehicle Topical Solution|Vehicle Topical Solution applied twice daily.
11324282|NCT03354637|OG001|Outcome|ATI-50002 0.12% Topical Solution|ATI-50002 0.12% Topical Solution applied twice daily.
11324283|NCT03354637|OG002|Outcome|ATI-50002 0.46% Topical Solution|ATI-50002 0.46% Topical Solution applied twice daily.
11324284|NCT03354637|EG000|Reported Event|Vehicle Topical Solution (Double Blind Period)|Vehicle Topical Solution applied twice daily during the double blind period of the study.
11324285|NCT03354637|EG001|Reported Event|ATI-50002 0.12% Topical Solution (Double Blind Period)|ATI-50002 0.12% Topical Solution applied twice daily during the double blind period of the study
11324286|NCT03354637|EG002|Reported Event|ATI-50002 0.46% Topical Solution (Double Blind Period)|ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study
11324287|NCT03354637|EG003|Reported Event|ATI-50002 0.46% Topical Solution (Open Label Extension Period)|ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
11324288|NCT03354663|BG000|Baseline|TactiCath SE|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation."
11324289|NCT03354663|FG000|Participant Flow|TactiCath SE|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation."
11324290|NCT03354663|OG000|Outcome|TactiCath SE - Safety Population|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation.~Includes all subjects with catheter inserted into vasculature."
11324291|NCT03354663|OG000|Outcome|TactiCath SE|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation."
11324292|NCT03354663|OG000|Outcome|RF Population|Group of subjects with at least some RF energy delivered
11324293|NCT03354663|OG000|Outcome|TactiCath SE|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE inserted"
11324294|NCT03354663|OG000|Outcome|TactiCath SE Drug-Free Success Population|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation.~Includes all subjects with catheter inserted into vasculature."
11324295|NCT03354663|EG000|Reported Event|TactiCath SE|"Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.~TactiCath SE: Ablation to achieve pulmonary vein isolation."
11324296|NCT03354754|BG000|Baseline|LYS228|IV infusion every 6 hours for at least 5 days
11324297|NCT03354754|BG001|Baseline|Standard of Care|IV infusion of standard of care antibiotics for at least 5 days
11324298|NCT03354754|BG002|Baseline|Total|Total of all reporting groups
11324299|NCT03354754|FG000|Participant Flow|LYS228|IV infusion every 6 hours for at least 5 days
11324300|NCT03354754|FG001|Participant Flow|Standard of Care|IV infusion of standard of care antibiotics for at least 5 days
11324301|NCT03354754|OG000|Outcome|LYS228|IV infusion every 6 hours for at least 5 days
11324302|NCT03354754|OG001|Outcome|Standard of Care|IV infusion of standard of care antibiotics for at least 5 days
11324303|NCT03354754|EG000|Reported Event|LYS228|IV infusion every 6 hours for at least 5 days
11324304|NCT03354754|EG001|Reported Event|Standard of Care|IV infusion of standard of care antibiotics for at least 5 days
11324305|NCT03355326|BG000|Baseline|Glycerin Suppository Group|Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
11324306|NCT03355326|BG001|Baseline|Non-suppository Group|Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
11324307|NCT03355326|BG002|Baseline|Total|Total of all reporting groups
11324308|NCT03355326|FG000|Participant Flow|Glycerin Suppository Group|Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
11324309|NCT03355326|FG001|Participant Flow|Non-suppository Group|Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
11324310|NCT03355326|OG000|Outcome|Glycerin Suppository Group|Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
11324311|NCT03355326|OG001|Outcome|Non-suppository Group|Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
11324312|NCT03355326|EG000|Reported Event|Glycerin Suppository Group|Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
11324313|NCT03355326|EG001|Reported Event|Non-suppository Group|Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
11324314|NCT03355742|BG000|Baseline|XIENCE|"XIENCE + Short duration (1 month) of DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure."
11324315|NCT03355742|FG000|Participant Flow|XIENCE|"XIENCE + Short duration (1 month) of DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure."
11324316|NCT03355742|OG000|Outcome|XIENCE|"XIENCE + Short duration (1 month) of DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure."
11324317|NCT03355742|EG000|Reported Event|XIENCE|"XIENCE + Short duration (1 month) of DAPT~XIENCE: Subjects who received XIENCE family stent systems will be included.~DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure."
11324318|NCT03355820|BG000|Baseline|HPV Group|Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.
11324319|NCT03355820|FG000|Participant Flow|HPV Group|Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.
11324320|NCT03355820|OG000|Outcome|HPV Group|Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.
11324321|NCT03355820|EG000|Reported Event|HPV Group|Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.
11324322|NCT03356145|BG000|Baseline|12 mL Arm|Participants receive injection of 12 mL of lidocaine.
11324323|NCT03356145|BG001|Baseline|20 mL Arm|Participants receive injection of 20 mL of lidocaine.
11324324|NCT03356145|BG002|Baseline|Total|Total of all reporting groups
11324325|NCT03356145|FG000|Participant Flow|12 mL Arm|Participants receive injection of 12 mL of lidocaine.
11324326|NCT03356145|FG001|Participant Flow|20 mL Arm|Participants receive injection of 20 mL of lidocaine.
11324327|NCT03356145|OG000|Outcome|12 mL Arm|Participants receive injection of 12 mL of lidocaine.
11324328|NCT03356145|OG001|Outcome|20 mL Arm|Participants receive injection of 20 mL of lidocaine.
11324329|NCT03356145|EG000|Reported Event|12 mL Arm|Participants receive injection of 12 mL of lidocaine.
11324330|NCT03356145|EG001|Reported Event|20 mL Arm|Participants receive injection of 20 mL of lidocaine.
11324331|NCT03356977|BG000|Baseline|Crisaborole Topical Ointment, 2 Percent|Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator.
11324332|NCT03356977|FG000|Participant Flow|Crisaborole Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator.
11324333|NCT03356977|OG000|Outcome|Crisaborole Topical Ointment, 2 Percent|Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator.
11324334|NCT03356977|EG000|Reported Event|Crisaborole Topical Ointment, 2 Percent|Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator.
11324335|NCT03357341|BG000|Baseline|Asthma Cohort|Asthma participants were identified via EHR database analyses, study provider referral (asthma diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324336|NCT03357341|BG001|Baseline|COPD Cohort|Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324337|NCT03357341|BG002|Baseline|Total|Total of all reporting groups
11324338|NCT03357341|FG000|Participant Flow|Asthma Cohort|Asthma participants were identified via EHR database analyses, study provider referral (asthma diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324339|NCT03357341|FG001|Participant Flow|COPD Cohort|Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324340|NCT03357341|OG000|Outcome|Asthma Cohort|Asthma participants were identified via EHR database analyses, study provider referral (asthma diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324341|NCT03357341|OG001|Outcome|COPD Cohort|Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324342|NCT03357341|OG000|Outcome|COPD Cohort|Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324343|NCT03357341|EG000|Reported Event|Asthma Cohort|Asthma participants were identified via EHR database analyses, study provider referral (asthma diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324344|NCT03357341|EG001|Reported Event|COPD Cohort|Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback.
11324345|NCT03357393|BG000|Baseline|Midazolam and Morphine-scopolamine|"Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.~Midazolam: Midazolam is givenas sedation to the Control arm.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324346|NCT03357393|BG001|Baseline|PCS (Propofol) With Morphine-scopolamine|"Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324347|NCT03357393|BG002|Baseline|PCS (Propofol) With Glycopyrronium Bromide|"Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~Glycopyrrolate: Given as premedication for one of the intervention arms.."
11324348|NCT03357393|BG003|Baseline|Total|Total of all reporting groups
11324349|NCT03357393|FG000|Participant Flow|Midazolam and Morphine-scopolamine|"Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.~Midazolam: Midazolam is givenas sedation to the Control arm.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324350|NCT03357393|FG001|Participant Flow|PCS (Propofol) With Morphine-scopolamine|"Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324351|NCT03357393|FG002|Participant Flow|PCS (Propofol) With Glycopyrronium Bromide|"Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~Glycopyrrolate: Given as premedication for one of the intervention arms.."
11324352|NCT03357393|OG000|Outcome|Midazolam and Morphine-scopolamine|"Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.~Midazolam: Midazolam is givenas sedation to the Control arm.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324353|NCT03357393|OG001|Outcome|PCS (Propofol) With Morphine-scopolamine|"Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324354|NCT03357393|OG002|Outcome|PCS (Propofol) With Glycopyrronium Bromide|"Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~Glycopyrrolate: Given as premedication for one of the intervention arms.."
11324355|NCT03357393|EG000|Reported Event|Midazolam and Morphine-scopolamine|"Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.~Midazolam: Midazolam is givenas sedation to the Control arm.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11324356|NCT03357393|EG001|Reported Event|PCS (Propofol) With Morphine-scopolamine|"Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms."
11333524|NCT03518008|FG001|Participant Flow|Clariti 1 Day, Then DDT2|Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product will be worn bilaterally for 1 week in a daily disposable modality.
11324357|NCT03357393|EG002|Reported Event|PCS (Propofol) With Glycopyrronium Bromide|"Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.~Propofol-Lipuro: Propofol is given as sedation to both intervention arms.~Glycopyrrolate: Given as premedication for one of the intervention arms.."
11324358|NCT03357471|BG000|Baseline|Certolizumab Pegol Q2W Injection by e-Device|Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
11324359|NCT03357471|BG001|Baseline|Certolizumab Pegol Q4W Injection by e-Device|Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
11324360|NCT03357471|BG002|Baseline|Total Title|
11324361|NCT03357471|FG000|Participant Flow|Certolizumab Pegol Q2W Injection by e-Device|Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
11324362|NCT03357471|FG001|Participant Flow|Certolizumab Pegol Q4W Injection by e-Device|Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
11324363|NCT03357471|OG000|Outcome|Certolizumab Pegol Q2W Injection by e-Device (SS)|Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects formed the Safety Set (SS).
11324364|NCT03357471|OG001|Outcome|Certolizumab Pegol Q4W Injection by e-Device (SS)|Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks. Subjects formed the Safety Set (SS).
11324365|NCT03357471|EG000|Reported Event|Certolizumab Pegol Q2W Injection by e-Device (SS)|Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects formed the Safety Set (SS).
11324366|NCT03357471|EG001|Reported Event|Certolizumab Pegol Q4W Injection by e-Device (SS)|Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks. Subjects formed the Safety Set (SS).
11324367|NCT03357614|BG000|Baseline|Sulopenem|"Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment~Sulopenem: Antibiotic therapy for complicated UTI~Sulopenem-Etzadroxil/Probenecid: Antibiotic therapy for complicated UTI"
11324368|NCT03357614|BG001|Baseline|Ertapenem|"Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment~Ertapenem: Antibiotic therapy for complicated UTI~Ciprofloxacin: Antibiotic therapy for complicated UTI~Amoxicillin-clavulanate: Antibiotic therapy for complicated UTI"
11324369|NCT03357614|BG002|Baseline|Total|Total of all reporting groups
11324370|NCT03357614|FG000|Participant Flow|Sulopenem|"Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment~Sulopenem: Antibiotic therapy for complicated UTI~Sulopenem-Etzadroxil/Probenecid: Antibiotic therapy for complicated UTI"
11324371|NCT03357614|FG001|Participant Flow|Ertapenem|"Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment~Ertapenem: Antibiotic therapy for complicated UTI~Ciprofloxacin: Antibiotic therapy for complicated UTI~Amoxicillin-clavulanate: Antibiotic therapy for complicated UTI"
11324372|NCT03357614|OG000|Outcome|Sulopenem|"Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment~Sulopenem: Antibiotic therapy for complicated UTI~Sulopenem-Etzadroxil/Probenecid: Antibiotic therapy for complicated UTI"
11324373|NCT03357614|OG001|Outcome|Ertapenem|"Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment~Ertapenem: Antibiotic therapy for complicated UTI~Ciprofloxacin: Antibiotic therapy for complicated UTI~Amoxicillin-clavulanate: Antibiotic therapy for complicated UTI"
11324374|NCT03357614|EG000|Reported Event|Sulopenem|"Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment~Sulopenem: Antibiotic therapy for complicated UTI~Sulopenem-Etzadroxil/Probenecid: Antibiotic therapy for complicated UTI"
11324375|NCT03357614|EG001|Reported Event|Ertapenem|"Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment~Ertapenem: Antibiotic therapy for complicated UTI~Ciprofloxacin: Antibiotic therapy for complicated UTI~Amoxicillin-clavulanate: Antibiotic therapy for complicated UTI"
11324376|NCT03357731|BG000|Baseline|Overall Participants|Inclusive of all treatments, all periods. Note: Participants crossed-over from either placebo, drug or NTG arm to the next (in various sequence) following Day 1 treatment and a minimum 5-day washout period, per arm.
11324377|NCT03357731|FG000|Participant Flow|Sequence 1|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: PBO-drug-NTG"
11324378|NCT03357731|FG001|Participant Flow|Sequence 2|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: PBO-NTG-drug"
11324379|NCT03357731|FG002|Participant Flow|Sequence 3|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: NTG-PBO-drug"
11324380|NCT03357731|FG003|Participant Flow|Sequence 4|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: NTG-drug-PBO"
11324381|NCT03357731|FG004|Participant Flow|Sequence 5|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: drug-PBO-NTG"
11324382|NCT03357731|FG005|Participant Flow|Sequence 6|"Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.~3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)~Sequence of treatment for this group is as follows: drug-NTG-PBO"
11324383|NCT03357731|OG000|Outcome|Placebo (PBO)|"Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324384|NCT03357731|OG001|Outcome|BMS-986231|"BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.~Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324385|NCT03357731|OG002|Outcome|Nitroglycerin (NTG)|"NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324386|NCT03357731|EG000|Reported Event|Placebo (PBO)|"Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324387|NCT03357731|EG001|Reported Event|BMS-986231|"BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.~Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324388|NCT03357731|EG002|Reported Event|Nitroglycerin (NTG)|"NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.~Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:~PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO"
11324389|NCT03358147|BG000|Baseline|GP MDI 28.8 μg|Glycopyrronium Metered Dose Inhalation 28.8 μg
11324390|NCT03358147|BG001|Baseline|GP MDI 14.4 μg|Glycopyrronium Metered Dose Inhalation 14.4 μg
11324391|NCT03358147|BG002|Baseline|GP MDI 7.2 μg|Glycopyrronium Metered Dose Inhalation 7.2μg
11324392|NCT03358147|BG003|Baseline|Placebo MDI|Placebo Metered Dose Inhalation
11324393|NCT03358147|BG004|Baseline|Spiriva Respimat 2.5 μg|Spiriva Respimat 2.5 μg
11324394|NCT03358147|BG005|Baseline|Total|Total of all reporting groups
11324395|NCT03358147|FG000|Participant Flow|GP MDI 28.8 μg|Glycopyrronium Metered Dose Inhalation 28.8 μg
11324396|NCT03358147|FG001|Participant Flow|GP MDI 14.4 μg|Glycopyrronium Metered Dose Inhalation 14.4 μg
11324397|NCT03358147|FG002|Participant Flow|GP MDI 7.2 μg|Glycopyrronium Metered Dose Inhalation 7.2μg
11324398|NCT03358147|FG003|Participant Flow|Placebo MDI|Placebo Metered Dose Inhalation
11324399|NCT03358147|FG004|Participant Flow|Spiriva Respimat 2.5 μg|Spiriva Respimat 2.5 μg
11324400|NCT03358147|OG000|Outcome|GP MDI 28.8 μg|Glycopyrronium Metered Dose Inhalation 28.8 μg
11324401|NCT03358147|OG001|Outcome|GP MDI 14.4 μg|Glycopyrronium Metered Dose Inhalation 14.4 μg
11324402|NCT03358147|OG002|Outcome|GP MDI 7.2 μg|Glycopyrronium Metered Dose Inhalation 7.2μg
11324403|NCT03358147|OG003|Outcome|Placebo MDI|Placebo Metered Dose Inhalation
11324404|NCT03358147|OG004|Outcome|Spiriva Respimat 2.5 μg|Spiriva Respimat 2.5 μg
11324405|NCT03358147|EG000|Reported Event|GP MDI 28.8 μg|Glycopyrronium Metered Dose Inhalation 28.8 μg
11324406|NCT03358147|EG001|Reported Event|GP MDI 14.4 μg|Glycopyrronium Metered Dose Inhalation 14.4 μg
11324407|NCT03358147|EG002|Reported Event|GP MDI 7.2 μg|Glycopyrronium Metered Dose Inhalation 7.2μg
11324408|NCT03358147|EG003|Reported Event|Placebo MDI|Placebo Metered Dose Inhalation
11324409|NCT03358147|EG004|Reported Event|Spiriva Respimat 2.5 μg|Spiriva Respimat 2.5 μg
11324410|NCT03358238|BG000|Baseline|No Weekly Review|"Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.~No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker."
11324411|NCT03358238|BG001|Baseline|Weekly Review|"Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.~Weekly review: Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker."
11324412|NCT03358238|BG002|Baseline|Total|Total of all reporting groups
11324413|NCT03358238|FG000|Participant Flow|No Weekly Review|Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
11324414|NCT03358238|FG001|Participant Flow|Weekly Review|Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
11324415|NCT03358238|OG000|Outcome|All Participants|All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.
11324416|NCT03358238|OG000|Outcome|Review Arm|Individuals who reviewed weekly data with an interviewer
11324417|NCT03358238|OG001|Outcome|No Review Arm|Individuals who did not review weekly data with an interviewer
11324418|NCT03358238|OG001|Outcome|No Review Arm|Individuals who did not review weekly data with an interviewer.
11324419|NCT03358238|OG000|Outcome|Review Arm Participants With Unequal Adherence|Participants who reviewed weekly data with an interviewer and whose adherence rates were unequal for the self-report method of symptom monitoring compared to the activity tracker method.
11324420|NCT03358238|OG001|Outcome|No Review Arm Participants With Unequal Adherence|Participants who did not review weekly data with interviewer and whose adherence rates for self-report and activity tracking differed
11324421|NCT03358238|EG000|Reported Event|No Weekly Review|"Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.~No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker."
11324422|NCT03358238|EG001|Reported Event|Weekly Review|"Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.~Weekly review: Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker."
11324423|NCT03358251|BG000|Baseline|SRP+Pocket-X Gel, Split-mouth|The single arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
11324424|NCT03358251|FG000|Participant Flow|SRP+Pocket-X Gel, Split-mouth|The single arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
11324425|NCT03358251|OG000|Outcome|Lower Jaw Pockets + Treatment|Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.
11324426|NCT03358251|OG001|Outcome|Lower Jaw Pockets - Control|Periodontal pockets situated in the lower jaw which received a tratment of SRP only.
11324427|NCT03358251|OG002|Outcome|Upper Jaw Pockets + Treatment|Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.
11324428|NCT03358251|OG003|Outcome|Upper Jaw Pockets + Control|Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
11324429|NCT03358251|EG000|Reported Event|SRP+Pocket-X Gel, Split-mouth|The single arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
11324430|NCT03358290|BG000|Baseline|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11324431|NCT03358290|BG001|Baseline|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11324432|NCT03358290|BG002|Baseline|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11324433|NCT03358290|BG003|Baseline|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11324434|NCT03358290|BG004|Baseline|Placebo|Placebo orally once daily for 12 weeks
11324435|NCT03358290|BG005|Baseline|Total|Total of all reporting groups
11324436|NCT03358290|FG000|Participant Flow|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11324437|NCT03358290|FG001|Participant Flow|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11324438|NCT03358290|FG002|Participant Flow|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11324439|NCT03358290|FG003|Participant Flow|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11324440|NCT03358290|FG004|Participant Flow|Placebo|Placebo orally once daily for 12 weeks
11324441|NCT03358290|OG000|Outcome|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11324442|NCT03358290|OG001|Outcome|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11324443|NCT03358290|OG002|Outcome|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11324444|NCT03358290|OG003|Outcome|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11324445|NCT03358290|OG004|Outcome|Placebo|Placebo orally once daily for 12 weeks
11324446|NCT03358290|EG000|Reported Event|JTE-051 50 mg|JTE-051 50 mg orally once daily for 12 weeks
11324447|NCT03358290|EG001|Reported Event|JTE-051 100 mg|JTE-051 100 mg orally once daily for 12 weeks
11324448|NCT03358290|EG002|Reported Event|JTE-051 150 mg|JTE-051 150 mg orally once daily for 12 weeks
11324449|NCT03358290|EG003|Reported Event|JTE-051 200 mg|JTE-051 200 mg orally once daily for 12 weeks
11324450|NCT03358290|EG004|Reported Event|Placebo|Placebo orally once daily for 12 weeks
11324451|NCT03358329|BG000|Baseline|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with 1350 mcg of MF~Mometasone furoate nasal spray (200 mcg) once daily"
11324452|NCT03358329|FG000|Participant Flow|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with 1350 mcg of MF~Mometasone furoate nasal spray (200 mcg) once daily"
11324453|NCT03358329|OG000|Outcome|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with 1350 mcg of MF~Mometasone furoate nasal spray (MFNS, 200 mcg) once daily"
11324454|NCT03358329|OG000|Outcome|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with 1350 mcg of MF~MFNS (200 mcg) once daily)"
11324455|NCT03358329|OG000|Outcome|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with 1350 mcg of MF.~MFNS (200 mcg) once daily"
11324456|NCT03358329|EG000|Reported Event|S8 Sinus Implant|"Corticosteroid-eluting Sinus Implant with1350 mcg MF.~MFNS (200 mcg) once daily"
11324457|NCT03358355|BG000|Baseline|Intervention|"Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324458|NCT03358355|FG000|Participant Flow|Unacylated Ghrelin Intervention|"Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324459|NCT03358355|OG000|Outcome|Intervention(10 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324460|NCT03358355|OG001|Outcome|Intervention(20 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324461|NCT03358355|OG002|Outcome|Intervention(40 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324462|NCT03358355|OG000|Outcome|Intervention|"Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324463|NCT03358355|EG000|Reported Event|Intervention(10 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 10 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324464|NCT03358355|EG001|Reported Event|Intervention(20 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 20 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324465|NCT03358355|EG002|Reported Event|Intervention(40 ug/kg)|"Subcutaneous injection of unacylated ghrelin: Doses of 40 ug/kg~unacelyated ghrelin: We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant."
11324466|NCT03358407|BG000|Baseline|Part A-Cohort 1: Placebo/GSK 4mg/GSK 10mg/GSK 30mg/GSK 100mg|Participants (Par.) received oral single dose of placebo matching GSK2983559 (GSK) in treatment period 1 followed by 4 milligram (mg) GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up (FU) visit after 14 days of last period.
11324467|NCT03358407|BG001|Baseline|Part A-Cohort 1: GSK 2mg/Placebo/GSK 10mg/GSK 30mg/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by placebo matching GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324468|NCT03358407|BG002|Baseline|Part A-Cohort 1: GSK 2mg/GSK 4mg/Placebo/GSK 30mg/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by placebo matching GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324469|NCT03358407|BG003|Baseline|Part A-Cohort 1: GSK 2mg/GSK 4mg/GSK 10mg/Placebo/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by placebo matching GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324470|NCT03358407|BG004|Baseline|Part A-Cohort 1: GSK 2mg/GSK 4mg/GSK 10mg/GSK 30mg/Placebo|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by placebo matching GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324471|NCT03358407|BG005|Baseline|Part A-Cohort 2: Placebo/GSK 400mg|Participants were administered oral single dose of placebo matching GSK2983559 in treatment period 1 followed by 400 mg GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324472|NCT03358407|BG006|Baseline|Part A-Cohort 2: GSK 200mg/ Placebo|Participants were administered oral single dose of 200 mg GSK2983559 in treatment period 1 followed by placebo matching GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324473|NCT03358407|BG007|Baseline|Part A-Cohort 2: GSK 200mg/GSK 400mg|Participants were administered oral single dose of 200 mg GSK2983559 in treatment period 1 followed by 400 mg GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324474|NCT03358407|BG008|Baseline|Part B: Placebo|Participants were planned to be administered placebo matching GSK2983559 either once daily or twice daily. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324475|NCT03358407|BG009|Baseline|Part B: GSK2983559|Participants were planned to be administered GSK2983559 in repeat ascending dose sequential period either once daily or twice daily based upon the pharmacokinetic, safety and tolerability observed in Part A. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324476|NCT03358407|BG010|Baseline|Total|Total of all reporting groups
11333525|NCT03518008|OG000|Outcome|DD T2|Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2 for 1 week in a daily disposable modality
11324477|NCT03358407|FG000|Participant Flow|Part A-Cohort 1: Placebo/GSK 4mg/GSK 10mg/GSK 30mg/GSK 100mg|Participants (Par.) received oral single dose of placebo matching GSK2983559 (GSK) in treatment period 1 followed by 4 milligram (mg) GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up (FU) visit after 14 days of last period.
11324478|NCT03358407|FG001|Participant Flow|Part A-Cohort 1: GSK 2mg/Placebo/GSK 10mg/GSK 30mg/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by placebo matching GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324479|NCT03358407|FG002|Participant Flow|Part A-Cohort 1: GSK 2mg/GSK 4mg/Placebo/GSK 30mg/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by placebo matching GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324480|NCT03358407|FG003|Participant Flow|Part A-Cohort 1: GSK 2mg/GSK 4mg/GSK 10mg/Placebo/GSK 100mg|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by placebo matching GSK2983559 in treatment period 4 followed by 100 mg GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324481|NCT03358407|FG004|Participant Flow|Part A-Cohort 1: GSK 2mg/GSK 4mg/GSK 10mg/GSK 30mg/Placebo|Participants received oral single dose of 2 mg GSK2983559 in treatment period 1 followed by 4 mg GSK2983559 in treatment period 2 followed by 10 mg GSK2983559 in treatment period 3 followed by 30 mg GSK2983559 in treatment period 4 followed by placebo matching GSK2983559 in treatment period 5. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period.
11324482|NCT03358407|FG005|Participant Flow|Part A-Cohort 2: Placebo/GSK 400mg|Participants were administered oral single dose of placebo matching GSK2983559 in treatment period 1 followed by 400 mg GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324483|NCT03358407|FG006|Participant Flow|Part A-Cohort 2: GSK 200mg/Placebo|Participants were administered oral single dose of 200 mg GSK2983559 in treatment period 1 followed by placebo matching GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324484|NCT03358407|FG007|Participant Flow|Part A-Cohort 2: GSK 200mg/GSK 400mg|Participants were administered oral single dose of 200 mg GSK2983559 in treatment period 1 followed by 400 mg GSK2983559 in treatment period 2. There was a washout period of at least 48-hours between 2 periods. There was a follow up visit after 14 days of last period. The periods 3, 4, and 5 were planned but no participants were enrolled in those periods due to early terminated of study. The study was terminated during period 2 of Part A-Cohort 2.
11324485|NCT03358407|FG008|Participant Flow|Part B: Placebo|Participants were planned to be administered placebo matching GSK2983559 either once daily or twice daily. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324486|NCT03358407|FG009|Participant Flow|Part B: GSK2983559|Participants were planned to be administered GSK2983559 in repeat ascending dose sequential period either once daily or twice daily based upon the pharmacokinetic, safety and tolerability observed in Part A. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324487|NCT03358407|OG000|Outcome|Part A: Placebo|All participants received single oral dose of placebo matching GSK2983559 as per randomization schedule.
11324488|NCT03358407|OG001|Outcome|Part A-Cohort 1: GSK2983559 2 mg|All participants received single oral dose of 2 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324489|NCT03358407|OG002|Outcome|Part A-Cohort 1: GSK2983559 4 mg|All participants received single oral dose of 4 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324490|NCT03358407|OG003|Outcome|Part A-Cohort 1: GSK2983559 10 mg|All participants received single oral dose of 10 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324491|NCT03358407|OG004|Outcome|Part A-Cohort 1: GSK2983559 30 mg|All participants received single oral dose of 30 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324492|NCT03358407|OG005|Outcome|Part A-Cohort 1: GSK2983559 100 mg|All participants received single oral dose of 100 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324493|NCT03358407|OG006|Outcome|Part A-Cohort 2: GSK2983559 200 mg|All participants received single oral dose of 200 mg GSK2983559 in Period 1.
11324494|NCT03358407|OG007|Outcome|Part A-Cohort 2: GSK2983559 400 mg|All participants received single oral dose of 400 mg GSK2983559 in Period 2.
11324495|NCT03358407|OG000|Outcome|Part B: Placebo|Participants were planned to be administered placebo matching GSK2983559 either once daily or twice daily. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324496|NCT03358407|OG001|Outcome|Part B: GSK2983559|Participants were planned to be administered GSK2983559 in repeat ascending dose sequential period either once daily or twice daily based upon the pharmacokinetic, safety and tolerability observed in Part A. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324497|NCT03358407|OG000|Outcome|Part A-Cohort 1: GSK2983559 2 mg|All participants received single oral dose of 2 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324498|NCT03358407|OG001|Outcome|Part A-Cohort 1: GSK2983559 4 mg|All participants received single oral dose of 4 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324499|NCT03358407|OG002|Outcome|Part A-Cohort 1: GSK2983559 10 mg|All participants received single oral dose of 10 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324500|NCT03358407|OG003|Outcome|Part A-Cohort 1: GSK2983559 30 mg|All participants received single oral dose of 30 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324501|NCT03358407|OG004|Outcome|Part A-Cohort 1: GSK2983559 100 mg|All participants received single oral dose of 100 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324502|NCT03358407|OG000|Outcome|Part A-Cohort 2: GSK2983559 200 mg|All participants received single oral dose of 200 mg GSK2983559 in Period 1.
11324503|NCT03358407|OG001|Outcome|Part A-Cohort 2: GSK2983559 400 mg|All participants received single oral dose of 400 mg GSK2983559 in Period 2.
11324504|NCT03358407|OG000|Outcome|Part B: GSK2983559|Participants were planned to be administered GSK2983559 in repeat ascending dose sequential period either once daily or twice daily based upon the pharmacokinetic, safety and tolerability observed in Part A. Though, no participants were enrolled in Part B since the study was terminated during Part A due to non-clinical toxicology findings and reduced safety margins.
11324505|NCT03358407|EG000|Reported Event|Part A: Placebo|All participants received single oral dose of placebo matching GSK2983559 as per randomization schedule.
11324506|NCT03358407|EG001|Reported Event|Part A-Cohort 1: GSK2983559 2 mg|All participants received single oral dose of 2 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324507|NCT03358407|EG002|Reported Event|Part A-Cohort 1: GSK2983559 4 mg|All participants received single oral dose of 4 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324508|NCT03358407|EG003|Reported Event|Part A-Cohort 1: GSK2983559 10 mg|All participants received single oral dose of 10 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324509|NCT03358407|EG004|Reported Event|Part A-Cohort 1: GSK2983559 30 mg|All participants received single oral dose of 30 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324510|NCT03358407|EG005|Reported Event|Part A-Cohort 1: GSK2983559 100 mg|All participants received single oral dose of 100 mg GSK2983559 either in Period 1 or Period 2 or Period 3 or Period 4 or Period 5 as per randomization schedule.
11324511|NCT03358407|EG006|Reported Event|Part A-Cohort 2: GSK2983559 200 mg|All participants received single oral dose of 200 mg GSK2983559 in Period 1.
11324512|NCT03358407|EG007|Reported Event|Part A-Cohort 2: GSK2983559 400 mg|All participants received single oral dose of 400 mg GSK2983559 in Period 2.
11324513|NCT03358576|BG000|Baseline|Sulopenem|"Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment~Sulopenem-Etzadroxil/Probenecid: Antibiotic for complicated intra-abdominal infection~Sulopenem: Antibiotic for complicated intra-abdominal infection"
11324514|NCT03358576|BG001|Baseline|Ertapenem|"Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead~Ertapenem: Antibiotic for complicated intra-abdominal infection~Ciprofloxacin: Antibiotic for complicated intra-abdominal infection~Metronidazole: Antibiotic for complicated intra-abdominal infection~Amoxicillin-Clavulanate: Antibiotic for complicated intra-abdominal infection"
11324515|NCT03358576|BG002|Baseline|Total|Total of all reporting groups
11324516|NCT03358576|FG000|Participant Flow|Sulopenem|"Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment~Sulopenem-Etzadroxil/Probenecid: Antibiotic for complicated intra-abdominal infection~Sulopenem: Antibiotic for complicated intra-abdominal infection"
11324517|NCT03358576|FG001|Participant Flow|Ertapenem|"Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead~Ertapenem: Antibiotic for complicated intra-abdominal infection~Ciprofloxacin: Antibiotic for complicated intra-abdominal infection~Metronidazole: Antibiotic for complicated intra-abdominal infection~Amoxicillin-Clavulanate: Antibiotic for complicated intra-abdominal infection"
11324518|NCT03358576|OG000|Outcome|Sulopenem|"Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment~Sulopenem-Etzadroxil/Probenecid: Antibiotic for complicated intra-abdominal infection~Sulopenem: Antibiotic for complicated intra-abdominal infection"
11324519|NCT03358576|OG001|Outcome|Ertapenem|"Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead~Ertapenem: Antibiotic for complicated intra-abdominal infection~Ciprofloxacin: Antibiotic for complicated intra-abdominal infection~Metronidazole: Antibiotic for complicated intra-abdominal infection~Amoxicillin-Clavulanate: Antibiotic for complicated intra-abdominal infection"
11324520|NCT03358576|EG000|Reported Event|Sulopenem|"Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment~Sulopenem-Etzadroxil/Probenecid: Antibiotic for complicated intra-abdominal infection~Sulopenem: Antibiotic for complicated intra-abdominal infection"
11333526|NCT03518008|OG001|Outcome|Clariti 1 Day|Somofilcon A contact lenses worn bilaterally during Period 1 or Period 2 for 1 week in a daily disposable modality.
11333527|NCT03518008|EG000|Reported Event|DD T2|All subjects exposed to verofilcon A contact lenses
11333528|NCT03518008|EG001|Reported Event|Clariti 1 Day|All subjects exposed to somofilcon A contact lenses
11324521|NCT03358576|EG001|Reported Event|Ertapenem|"Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead~Ertapenem: Antibiotic for complicated intra-abdominal infection~Ciprofloxacin: Antibiotic for complicated intra-abdominal infection~Metronidazole: Antibiotic for complicated intra-abdominal infection~Amoxicillin-Clavulanate: Antibiotic for complicated intra-abdominal infection"
11324522|NCT03359395|BG000|Baseline|Alfentanil Then Placebo Arm 1|Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324523|NCT03359395|BG001|Baseline|Placebo Then Alfentanil Arm 2|Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324524|NCT03359395|BG002|Baseline|Total|Total of all reporting groups
11324525|NCT03359395|FG000|Participant Flow|Alfentanil Then Placebo|Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324526|NCT03359395|FG001|Participant Flow|Placebo Then Afentanil|Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324527|NCT03359395|OG000|Outcome|Alfentanil|Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324528|NCT03359395|OG001|Outcome|Placebo|Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324529|NCT03359395|EG000|Reported Event|Alfentanil|Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324530|NCT03359395|EG001|Reported Event|Placebo|Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
11324531|NCT03359473|BG000|Baseline|Placebo- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324532|NCT03359473|BG001|Baseline|GSK2881078 1.0 mg- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
11324533|NCT03359473|BG002|Baseline|Placebo- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324534|NCT03359473|BG003|Baseline|GSK2881078 2.0 mg- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
11324535|NCT03359473|BG004|Baseline|Total|Total of all reporting groups
11324536|NCT03359473|FG000|Participant Flow|Placebo- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324537|NCT03359473|FG001|Participant Flow|GSK2881078 1.0 mg- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
11324538|NCT03359473|FG002|Participant Flow|Placebo- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324539|NCT03359473|FG003|Participant Flow|GSK2881078 2.0 mg- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
11324540|NCT03359473|OG000|Outcome|Placebo- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324541|NCT03359473|OG001|Outcome|GSK2881078 1.0 mg- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
11324542|NCT03359473|OG002|Outcome|Placebo- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324543|NCT03359473|OG003|Outcome|GSK2881078 2.0 mg- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
11324544|NCT03359473|OG000|Outcome|GSK2881078 1.0 mg- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
11324545|NCT03359473|OG000|Outcome|Placebo- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324546|NCT03359473|OG001|Outcome|GSK2881078 2.0 mg- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
11324547|NCT03359473|EG000|Reported Event|Placebo- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324548|NCT03359473|EG001|Reported Event|GSK2881078 1.0 mg- Female Participants|Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
11324549|NCT03359473|EG002|Reported Event|Placebo- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
11324550|NCT03359473|EG003|Reported Event|GSK2881078 2.0 mg- Male Participants|Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
11324551|NCT03359590|BG000|Baseline|All Study Participants|"Drug: Sitagliptin or placebo~The treatment consists of sitagliptin 100 mg/day or placebo for up to 24 weeks."
11324552|NCT03359590|FG000|Participant Flow|Sequence 1|"First intervention: treatment with sitagliptin tablets (100 mg/day) for up to 24 weeks.~Washout 4 weeks Second intervention: treatment with placebo tablets for up to 24 weeks."
11324553|NCT03359590|FG001|Participant Flow|Sequence 2|First intervention: treatment with placebo tablets for up to 24 weeks. Washout 4 weeks Second intervention: treatment with sitagliptin tablets (100 mg/day) for up to 24 weeks.
11324554|NCT03359590|OG000|Outcome|Sitagliptin Arm|"Drug: Sitagliptin~The treatment consists of sitagliptin 100 mg/day up to a maximum of 24 weeks."
11324555|NCT03359590|OG001|Outcome|Placebo Arm|"Drug: Placebo~The treatment consists of placebo up to a maximum of 24 weeks."
11324556|NCT03359590|EG000|Reported Event|Sitagliptin Arm|"Drug: Sitagliptin~The treatment consists of sitagliptin 100 mg/day up to a maximum of 24 weeks."
11324557|NCT03359590|EG001|Reported Event|Placebo Arm|"Drug: Placebo~The treatment consists of placebo up to a maximum of 24 weeks."
11324558|NCT03359629|BG000|Baseline|Blood Collection (Healthy Individuals)|Participants's blood was collected and measured for glucose level before and after food intake
11324559|NCT03359629|BG001|Baseline|Blood Collection (Diabetic Patients)|Participants's blood was collected and measured for glucose level
11324560|NCT03359629|BG002|Baseline|Total|Total of all reporting groups
11324561|NCT03359629|FG000|Participant Flow|Blood Collection (Healthy Individuals)|Participants's blood was collected and measured for glucose level before and after food intake
11324562|NCT03359629|FG001|Participant Flow|Blood Collection (Diabetic Patients)|Participants's blood was collected and measured for glucose level
11324563|NCT03359629|OG000|Outcome|Blood Collection (Healthy Individuals)|Participants's blood was collected and measured for glucose level before and after food intake
11324564|NCT03359629|OG001|Outcome|Blood Collection (Diabetic Patients)|Participants's blood was collected and measured for glucose level
11324565|NCT03359629|EG000|Reported Event|Blood Collection (Healthy Individuals)|Participants's blood was collected and measured for glucose level before and after food intake
11324566|NCT03359629|EG001|Reported Event|Blood Collection (Diabetic Patients)|Participants's blood was collected and measured for glucose level
11324567|NCT03359850|BG000|Baseline|Participants With Normal Hepatic Function|All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight >= 77 kilograms (kg) and current platelet count of >=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight < 77 kg and/or current platelet count of <150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324568|NCT03359850|BG001|Baseline|Participants With Impaired Hepatic Function|All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324569|NCT03359850|BG002|Baseline|Total|Total of all reporting groups
11324570|NCT03359850|FG000|Participant Flow|Participants With Normal Hepatic Function|All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight >= 77 kilograms (kg) and current platelet count of >=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight < 77 kg and/or current platelet count of <150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324571|NCT03359850|FG001|Participant Flow|Participants With Impaired Hepatic Function|All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324572|NCT03359850|OG000|Outcome|Participants With Normal Hepatic Function|All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight >= 77 kilograms (kg) and current platelet count of >=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight < 77 kg and/or current platelet count of <150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324573|NCT03359850|OG001|Outcome|Participants With Impaired Hepatic Function|All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324574|NCT03359850|EG000|Reported Event|Participants With Normal Hepatic Function-PK Phase|All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight >= 77 kilograms (kg) and current platelet count of >=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight < 77 kg and/or current platelet count of <150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324575|NCT03359850|EG001|Reported Event|Participants With Impaired Hepatic Function-PK Phase|All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11333529|NCT03518125|BG000|Baseline|Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333530|NCT03518125|BG001|Baseline|Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)|Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
11333531|NCT03518125|BG002|Baseline|Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11324576|NCT03359850|EG002|Reported Event|Participants With Normal Hepatic Function-Extension Phase|All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight >= 77 kilograms (kg) and current platelet count of >=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight < 77 kg and/or current platelet count of <150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324577|NCT03359850|EG003|Reported Event|Participants With Impaired Hepatic Function-Extension Phase|All participants received a single dose of 300 mg (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants received niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
11324578|NCT03359889|BG000|Baseline|Praxbind®|Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
11324579|NCT03359889|FG000|Participant Flow|Praxbind®|Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
11324580|NCT03359889|OG000|Outcome|Praxbind®|Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
11324581|NCT03359889|EG000|Reported Event|Praxbind®|Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
11324582|NCT03360071|BG000|Baseline|Allergen Immunotherapy Group|Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
11324583|NCT03360071|BG001|Baseline|Control Group|Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
11324584|NCT03360071|BG002|Baseline|Total|Total of all reporting groups
11324585|NCT03360071|FG000|Participant Flow|Allergen Immunotherapy Group|Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
11324586|NCT03360071|FG001|Participant Flow|Control Group|Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
11324587|NCT03360071|OG000|Outcome|Allergen Immunotherapy Group|Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
11324588|NCT03360071|OG001|Outcome|Control Group|Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
11324589|NCT03360071|EG000|Reported Event|Allergen Immunotherapy Group|Allergen Immunotherapy Extract: Allergen Immunotherapy treatment mixture to be delivered subcutaneously
11324590|NCT03360071|EG001|Reported Event|Control Group|Allergen Immunotherapy Control: Allergen Immunotherapy Control Solution to be delivered subcutaneously
11324591|NCT03360110|BG000|Baseline|Overall Study|"Subjects randomized to wear pair of test/control lens either first or second, then wear other lens.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324592|NCT03360110|FG000|Participant Flow|Test Lens, Then Control Lens|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324593|NCT03360110|FG001|Participant Flow|Control Lens, Then Test Lens|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324594|NCT03360110|OG000|Outcome|Phoebe Test Lens|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324595|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324596|NCT03360110|OG000|Outcome|Phoebe Test Lens: Upper Lid|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324597|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: Upper Lid|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324598|NCT03360110|OG000|Outcome|Phoebe Test Lens: Lower Lid|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11333532|NCT03518125|BG003|Baseline|Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)|Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
11324599|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: Lower Lid|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324600|NCT03360110|OG000|Outcome|Phoebe Test Lens: Upper Lid|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324601|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: Upper Lid|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324602|NCT03360110|OG000|Outcome|Phoebe Test Lens: Lower Lid|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324603|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: Lower Lid|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324604|NCT03360110|OG000|Outcome|Phoebe Test Lens: Dispense|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324605|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: Dispense|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324606|NCT03360110|OG000|Outcome|Phoebe Test Lens: 3 Days|"Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324607|NCT03360110|OG001|Outcome|Stenfilcon A Control Lens: 3 Days|"Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.~Phoebe test lens: Daily disposable contact lens~stenfilcon A lens (control): Daily disposable contact lens"
11324608|NCT03360110|EG000|Reported Event|Test Lens|"Subjects were randomized to wear pair of test lens for 3 days.~Phoebe test lens: Daily disposable contact lens"
11324609|NCT03360110|EG001|Reported Event|Stenfilcon A Lens (Control)|"Subjects were randomized to wear pair of control lens for 3 days.~stenfilcon A lens (control): Daily disposable contact lens"
11324610|NCT03360344|BG000|Baseline|Kinesio Tape|"Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study.~A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 12 inch Tape: Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study."
11324611|NCT03360344|BG001|Baseline|Standard of Care|"Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.~Cock up Splint and Lumbrical exercises: A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants."
11324612|NCT03360344|BG002|Baseline|Control Group|"Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 4 inch Tape: Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study."
11324613|NCT03360344|BG003|Baseline|Total|Total of all reporting groups
11324614|NCT03360344|FG000|Participant Flow|Kinesio Tape|"Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study.~A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 12 inch Tape: Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study."
11333533|NCT03518125|BG004|Baseline|Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333534|NCT03518125|BG005|Baseline|Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11333535|NCT03518125|BG006|Baseline|Total|Total of all reporting groups
11324615|NCT03360344|FG001|Participant Flow|Standard of Care|"Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.~Cock up Splint and Lumbrical exercises: A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants."
11324616|NCT03360344|FG002|Participant Flow|Control Group|"Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 4 inch Tape: Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study."
11324617|NCT03360344|OG000|Outcome|Kinesio Tape|"Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study.~A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 12 inch Tape: Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study."
11324618|NCT03360344|OG001|Outcome|Standard of Care|"Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.~Cock up Splint and Lumbrical exercises: A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants."
11324619|NCT03360344|OG002|Outcome|Control Group|"Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 4 inch Tape: Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study."
11324620|NCT03360344|EG000|Reported Event|Kinesio Tape|"Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study.~A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 12 inch Tape: Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study."
11324621|NCT03360344|EG001|Reported Event|Control Group|"Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit.~Kinesio 4 inch Tape: Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study."
11324622|NCT03360344|EG002|Reported Event|Standard of Care|"Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.~Cock up Splint and Lumbrical exercises: A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants."
11324623|NCT03360747|BG000|Baseline|AKCEA-ANGPTL3-LRx 20 mg|Participants received a SC injection of AKCEA-ANGPTL3-LRx, 20 mg, QW for 13-weeks of treatment period. Participants were followed up to Week 26.
11324624|NCT03360747|FG000|Participant Flow|AKCEA-ANGPTL3-LRx 20 mg|Participants received a subcutaneous (SC) injection of AKCEA-ANGPTL3-LRx, 20 milligrams (mg), weekly (QW) for 13-weeks of treatment period. Participants were followed up to Week 26.
11324625|NCT03360747|OG000|Outcome|AKCEA-ANGPTL3-LRx 20 mg|Participants received a SC injection of AKCEA-ANGPTL3-LRx, 20 mg, QW for 13-weeks of treatment period. Participants were followed up to Week 26.
11324626|NCT03360747|EG000|Reported Event|AKCEA-ANGPTL3-LRx 20 mg|Participants received a SC injection of AKCEA-ANGPTL3-LRx, 20 mg, QW for 13-weeks of treatment period. Participants were followed up to Week 26.
11333536|NCT03518125|FG000|Participant Flow|Age ≥ 66 Years: BioThrax (Day 1, Day 15, and Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333537|NCT03518125|FG001|Participant Flow|Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)|Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
11324627|NCT03361137|BG000|Baseline|PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled but did not have surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324628|NCT03361137|BG001|Baseline|PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324629|NCT03361137|BG002|Baseline|PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324630|NCT03361137|BG003|Baseline|PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324631|NCT03361137|BG004|Baseline|PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324632|NCT03361137|BG005|Baseline|Total|Total of all reporting groups
11324633|NCT03361137|FG000|Participant Flow|PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled but did not have surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324634|NCT03361137|FG001|Participant Flow|PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324635|NCT03361137|FG002|Participant Flow|PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324636|NCT03361137|FG003|Participant Flow|PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324637|NCT03361137|FG004|Participant Flow|PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11333538|NCT03518125|FG002|Participant Flow|Age ≥ 66 Years: AV7909 (Days 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11333539|NCT03518125|FG003|Participant Flow|Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)|Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
11324638|NCT03361137|OG000|Outcome|PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled but did not have surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324639|NCT03361137|OG001|Outcome|PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324640|NCT03361137|OG002|Outcome|PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324641|NCT03361137|OG003|Outcome|PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324642|NCT03361137|OG004|Outcome|PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324643|NCT03361137|OG000|Outcome|PwHA With Inhibitors, Emicizumab: All Surgery Cohorts|This analysis set included all participants with Hemophilia A (PwHA) with inhibitors who had undergone surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324644|NCT03361137|OG001|Outcome|PwHA Without Inhibitors, Emicizumab: All Surgery Cohorts|This analysis set included all participants with Hemophilia A (PwHA) without inhibitors who had undergone surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324645|NCT03361137|EG000|Reported Event|PwHA With Inhibitors, Emicizumab: Surgery Not Performed Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled but did not have surgery. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324646|NCT03361137|EG001|Reported Event|PwHA With Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324647|NCT03361137|EG002|Reported Event|PwHA With Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) with inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
10827894|NCT00112242|EG004|Reported Event|5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2|"If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2~If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2"
11324648|NCT03361137|EG003|Reported Event|PwHA Without Inhibitors, Emicizumab: CVAD Removal Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for central venous access device (CVAD) removal. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324649|NCT03361137|EG004|Reported Event|PwHA Without Inhibitors, Emicizumab: Simple Dental Extraction Cohort|This cohort included participants with Hemophilia A (PwHA) without inhibitors that were enrolled and had surgery for simple dental extraction. All participants received emicizumab via subcutaneous (SC) injection at a loading dose of 3 milligrams of medication per kilogram of body weight (mg/kg) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as they continued to derive sufficient benefit. Participants must have received all loading doses prior to surgery and planned to continue emicizumab for a minimum of 1 month after surgery.
11324650|NCT03361176|BG000|Baseline|Control|"Control Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate: Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC."
11324651|NCT03361176|BG001|Baseline|w/ Triamcinolone|"Experimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate with Triamcinolone acetate: Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point"
11324652|NCT03361176|BG002|Baseline|Total|Total of all reporting groups
11324653|NCT03361176|FG000|Participant Flow|Control|"Control Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate: Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC."
11324654|NCT03361176|FG001|Participant Flow|w/ Triamcinolone|"Experimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate with Triamcinolone acetate: Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point"
11324655|NCT03361176|OG000|Outcome|Control|"Control Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate: Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC."
11324656|NCT03361176|OG001|Outcome|w/ Triamcinolone|"Experimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session.~Injectable sodium deoxycholate with Triamcinolone acetate: Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point"
11324657|NCT03361176|EG000|Reported Event|w/ Triamcinolone|Adverse events related to Triamcinolone Group
11324658|NCT03361176|EG001|Reported Event|Control|Adverse events related to Control Group
11324659|NCT03361293|BG000|Baseline|Cognitive Training and Active tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).~Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)~Cognitive training: BrainHQ Computerized cognitive training"
11324660|NCT03361293|BG001|Baseline|Cognitive Training and Sham tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of placebo stimulation with tDCS (ramp-up, but no actual stimulation).~Cognitive training: BrainHQ Computerized cognitive training~Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)"
11324661|NCT03361293|BG002|Baseline|Total|Total of all reporting groups
11333540|NCT03518125|FG004|Participant Flow|Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11324662|NCT03361293|FG000|Participant Flow|Cognitive Training and Active tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).~Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)~Cognitive training: BrainHQ Computerized cognitive training"
11324663|NCT03361293|FG001|Participant Flow|Cognitive Training and Sham tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of placebo stimulation with tDCS (ramp-up, but no actual stimulation).~Cognitive training: BrainHQ Computerized cognitive training~Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)"
11324664|NCT03361293|OG000|Outcome|Cognitive Training and Active tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).~Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)~Cognitive training: BrainHQ Computerized cognitive training"
11324665|NCT03361293|OG001|Outcome|Cognitive Training and Sham tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of placebo stimulation with tDCS (ramp-up, but no actual stimulation).~Cognitive training: BrainHQ Computerized cognitive training~Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)"
11324666|NCT03361293|EG000|Reported Event|Cognitive Training and Active tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).~Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)~Cognitive training: BrainHQ Computerized cognitive training"
11324667|NCT03361293|EG001|Reported Event|Cognitive Training and Sham tDCS|"5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of placebo stimulation with tDCS (ramp-up, but no actual stimulation).~Cognitive training: BrainHQ Computerized cognitive training~Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)"
11324668|NCT03361423|BG000|Baseline|Treatment of Migraine With Active Device|"Treatment of acute migraine with an active form of Nerivio migra-1 device~Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as pain inhibits pain principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site."
11324669|NCT03361423|BG001|Baseline|Treatment of Migraine With Sham Device|"Treatment of acute migraine with a sham form of the Nerivio Migra-1 device~Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus."
11324670|NCT03361423|BG002|Baseline|Total|Total of all reporting groups
11324671|NCT03361423|FG000|Participant Flow|Treatment of Migraine With Active Device|"Treatment of acute migraine with an active form of Nerivio migra-1 device~Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as pain inhibits pain principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site."
11324672|NCT03361423|FG001|Participant Flow|Treatment of Migraine With Sham Device|"Treatment of acute migraine with a sham form of the Nerivio Migra-1 device~Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus."
11324673|NCT03361423|OG000|Outcome|Treatment of Migraine With Active Device|"Treatment of acute migraine with an active form of Nerivio migra-1 device~Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as pain inhibits pain principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site."
11324674|NCT03361423|OG001|Outcome|Treatment of Migraine With Sham Device|"Treatment of acute migraine with a sham form of the Nerivio Migra-1 device~Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus."
11324675|NCT03361423|EG000|Reported Event|Treatment of Migraine With Active Device|"Treatment of acute migraine with an active form of Nerivio migra-1 device~Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as pain inhibits pain principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site."
11324676|NCT03361423|EG001|Reported Event|Treatment of Migraine With Sham Device|"Treatment of acute migraine with a sham form of the Nerivio Migra-1 device~Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus."
11324677|NCT03361605|BG000|Baseline|Propofol Administration|Propofol: Propofol administration
11324678|NCT03361605|FG000|Participant Flow|Propofol Administration|Propofol: Propofol administration
11324679|NCT03361605|OG000|Outcome|Propofol Administration|Propofol: Propofol administration
11324680|NCT03361605|EG000|Reported Event|Propofol Administration|Propofol: Propofol administration
11324681|NCT03361917|BG000|Baseline|Endocuff Vision|"Colonoscopy with Endocuff Vision attached to distal end of scope~Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure."
11324682|NCT03361917|BG001|Baseline|Control Arm (Standard Colonscopy)|Standard colonoscopy with no device attachments
11324683|NCT03361917|BG002|Baseline|Total|Total of all reporting groups
11324684|NCT03361917|FG000|Participant Flow|Control Arm (Standard Colonscopy)|Standard colonoscopy with no device attachments
11324685|NCT03361917|FG001|Participant Flow|Endocuff Vision|"Colonoscopy with Endocuff Vision attached to distal end of scope~Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure."
11324686|NCT03361917|OG000|Outcome|Endocuff Vision|"Colonoscopy with Endocuff Vision attached to distal end of scope~Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure."
11324687|NCT03361917|OG001|Outcome|Control Arm (Standard Colonscopy)|Standard colonoscopy with no device attachments
11324688|NCT03361917|EG000|Reported Event|Control Arm (Standard Colonscopy)|Standard colonoscopy with no device attachments
11324689|NCT03361917|EG001|Reported Event|Endocuff Vision|"Colonoscopy with Endocuff Vision attached to distal end of scope~Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure."
11324690|NCT03362879|BG000|Baseline|Participants With Advanced Parkinson's Disease|Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
11324691|NCT03362879|FG000|Participant Flow|Participants With Advanced Parkinson's Disease|Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
11324692|NCT03362879|OG000|Outcome|Participants With Advanced Parkinson's Disease|Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
11324693|NCT03362879|OG000|Outcome|Percentage of Physicians|Percentage of Physicians with Overall Preference for LCGI Monotherapy.
11324694|NCT03362879|EG000|Reported Event|Participants With Advanced Parkinson's Disease|Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
11324695|NCT03362944|BG000|Baseline|Overall Study|"Includes all participants in both treatment arms:~Active Music Therapy followed by Passive Music Therapy~Passive Music Therapy followed by Active Music Therapy~Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.~Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.~For each arm interventions were spaced at minimum one week apart."
11324696|NCT03362944|FG000|Participant Flow|Active Music Therapy Followed by Passive Music Therapy|"Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.~Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.~Interventions were spaced at minimum one week apart."
11324697|NCT03362944|FG001|Participant Flow|Passive Music Therapy Followed by Active Music Therapy|"Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.~Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.~Interventions were spaced at minimum one week apart."
11324698|NCT03362944|OG000|Outcome|Active Music Therapy|Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
11324699|NCT03362944|OG001|Outcome|Passive Music Therapy|Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
11324700|NCT03362944|EG000|Reported Event|Active Music Therapy|Active Music Therapy: The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
11324701|NCT03362944|EG001|Reported Event|Passive Music Therapy|Passive Music Therapy: The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
11324702|NCT03362957|BG000|Baseline|GAE Procedure|"Patients will be randomized to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324703|NCT03362957|BG001|Baseline|Sham Procedure First, Then GAE Procedure|"Patients will be randomized to a sham procedure.~Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram~If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324704|NCT03362957|BG002|Baseline|Total|Total of all reporting groups
11324705|NCT03362957|FG000|Participant Flow|GAE Procedure|"Patients will be randomized to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324706|NCT03362957|FG001|Participant Flow|Sham Procedure First, Then GAE Procedure|"Patients will be randomized to a sham procedure.~Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram~If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11333541|NCT03518125|FG005|Participant Flow|Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11324707|NCT03362957|OG000|Outcome|GAE Procedure|"Patients will be randomized to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324708|NCT03362957|OG001|Outcome|Sham Procedure|"Patients will be randomized to a sham procedure.~Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram"
11324709|NCT03362957|OG002|Outcome|Crossover Arm|"If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324710|NCT03362957|EG000|Reported Event|GAE Procedure|"Patients will be randomized to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324711|NCT03362957|EG001|Reported Event|Sham Procedure|"Patients will be randomized to a sham procedure.~Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram"
11324712|NCT03362957|EG002|Reported Event|Crossover Arm|"If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure~Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis."
11324713|NCT03363321|BG000|Baseline|Cohort 1: 300mg - 300mg Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365.
11324714|NCT03363321|BG001|Baseline|Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324715|NCT03363321|BG002|Baseline|Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324716|NCT03363321|BG003|Baseline|Cohort 4: 300mg - 300mg Inhibitor|Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365.
11324717|NCT03363321|BG004|Baseline|Cohort 5: De Novo 300mg Loading + 150mg Inhibitors|De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365.
11324718|NCT03363321|BG005|Baseline|Total|Total of all reporting groups
11324719|NCT03363321|FG000|Participant Flow|Cohort 1: 300mg - 300mg Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365.
11324720|NCT03363321|FG001|Participant Flow|Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324721|NCT03363321|FG002|Participant Flow|Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324722|NCT03363321|FG003|Participant Flow|Cohort 4: 300mg - 300mg Inhibitor|Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365.
11324723|NCT03363321|FG004|Participant Flow|Cohort 5: De Novo 300mg Loading + 150mg Inhibitors|De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365.
11324724|NCT03363321|OG000|Outcome|Cohort 1: 300mg - 300mg Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365.
11324725|NCT03363321|OG001|Outcome|Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324726|NCT03363321|OG002|Outcome|Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324727|NCT03363321|OG003|Outcome|Cohort 4: 300mg - 300mg Inhibitor|Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365.
11324728|NCT03363321|OG004|Outcome|Cohort 5: De Novo 300mg Loading + 150mg Inhibitors|De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365.
11324729|NCT03363321|OG000|Outcome|Cohort 5: De Novo 300mg Loading + 150mg Inhibitors|De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365.
11324730|NCT03363321|EG000|Reported Event|Cohort 1: 300mg - 300mg Non-Inhibitor|Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) from Cohort 1 of Study 1002 (B7841002, NCT02974855) continued to receive PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 365.
11324731|NCT03363321|EG001|Reported Event|Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 2 of Study 1002 continued to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324732|NCT03363321|EG002|Reported Event|Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor|Participants without inhibitors to FVIII or FIX from Cohort 3 (450 mg SC) of Study 1002 started to receive PF-06741086 300 mg loading dose on Day 1 and 150 mg SC QW from Day 29 to Day 365.
11324733|NCT03363321|EG003|Reported Event|Cohort 4: 300mg - 300mg Inhibitor|Participants with inhibitors to FVIII or FIX from Cohort 4 (300 mg SC) of Study 1002 continued to receive PF-06741086 300 mg SC QW from Day 1 to Day 365.
11333542|NCT03518125|OG000|Outcome|Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11324734|NCT03363321|EG004|Reported Event|Cohort 5: De Novo 300mg Loading + 150mg Inhibitors|De Novo participants with inhibitors to FVIII or FIX received a 300 mg SC loading dose on Day 1, and then followed by 150 mg SC QW to Day 365.
11324735|NCT03363776|BG000|Baseline|Arm A (Part 1)|"BMS-986277 IV 3 X 10^10~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324736|NCT03363776|BG001|Baseline|Arm B (Part 1)|"BMS-986277 IV 3 X 10^11~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324737|NCT03363776|BG002|Baseline|Arm C (Part 1)|"BMS-986277 IV 1 X 10^12~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324738|NCT03363776|BG003|Baseline|Total|Total of all reporting groups
11324739|NCT03363776|FG000|Participant Flow|Arm A (Part 1)|"BMS-986277 IV 3 X 10^10~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324740|NCT03363776|FG001|Participant Flow|Arm B (Part 1)|"BMS-986277 IV 3 X 10^11~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324741|NCT03363776|FG002|Participant Flow|Arm C (Part 1)|"BMS-986277 IV 1 X 10^12~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324742|NCT03363776|OG000|Outcome|Arm A (Part 1)|"BMS-986277 IV 3 X 10^10~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324743|NCT03363776|OG001|Outcome|Arm B (Part 1)|"BMS-986277 IV 3 X 10^11~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324744|NCT03363776|OG002|Outcome|Arm C (Part 1)|"BMS-986277 IV 1 X 10^12~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324745|NCT03363776|EG000|Reported Event|Arm A (Part 1)|"BMS-986277 IV 3 X 10^10~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324746|NCT03363776|EG001|Reported Event|Arm B (Part 1)|"BMS-986277 IV 3 X 10^11~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324747|NCT03363776|EG002|Reported Event|Arm C (Part 1)|"BMS-986277 IV 1 X 10^12~Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277."
11324748|NCT03363854|BG000|Baseline|Tralokinumab Q2W+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11324749|NCT03363854|BG001|Baseline|Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11324750|NCT03363854|BG002|Baseline|Total|Total of all reporting groups
11324751|NCT03363854|FG000|Participant Flow|Tralokinumab Q2W+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11324752|NCT03363854|FG001|Participant Flow|Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11324753|NCT03363854|FG002|Participant Flow|Tralokinumab R/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324754|NCT03363854|FG003|Participant Flow|Tralokinumab R/Q4W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30."
11333543|NCT03518125|OG001|Outcome|Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)|Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
11333544|NCT03518125|OG002|Outcome|Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11324755|NCT03363854|FG004|Participant Flow|Tralokinumab NR/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324756|NCT03363854|FG005|Participant Flow|Placebo NR/Tralokinumab Q2W+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324757|NCT03363854|FG006|Participant Flow|Placebo R/Placebo+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants were administered placebo Q2W from Week 16 to Week 30."
11324758|NCT03363854|FG007|Participant Flow|Safety Follow-up|Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
11324759|NCT03363854|OG000|Outcome|Tralokinumab Q2W+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11324760|NCT03363854|OG001|Outcome|Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11324761|NCT03363854|OG000|Outcome|Initial Treatment Period - Tralokinumab Q2W+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11324762|NCT03363854|OG001|Outcome|Initial Treatment Period - Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11324763|NCT03363854|OG002|Outcome|Continuation Treatment Period - Tralokinumab R/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324764|NCT03363854|OG003|Outcome|Continuation Treatment Period - Tralokinumab R/Q4W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30."
11324765|NCT03363854|OG004|Outcome|Continuation Treatment Period - Tralokinumab NR/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324766|NCT03363854|OG005|Outcome|Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324767|NCT03363854|OG006|Outcome|Continuation Treatment Period - Placebo R/Placebo+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants were administered placebo Q2W from Week 16 to Week 30."
11333545|NCT03518125|OG003|Outcome|Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)|Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
11333546|NCT03518125|OG004|Outcome|Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11324768|NCT03363854|OG000|Outcome|Tralokinumab R/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324769|NCT03363854|OG001|Outcome|Tralokinumab R/Q4W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30."
11324770|NCT03363854|OG000|Outcome|Tralokinumab R/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as a reduction in EASI of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324771|NCT03363854|OG001|Outcome|Tralokinumab R/Q4W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as a reduction in EASI of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30."
11324772|NCT03363854|EG000|Reported Event|Initial Treatment Period: Tralokinumab Q2W+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.~Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16."
11324773|NCT03363854|EG001|Reported Event|Initial Treatment Period: Placebo+TCS|"Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.~Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16."
11324774|NCT03363854|EG002|Reported Event|Continuation Treatment Period: Tralokinumab R/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324775|NCT03363854|EG003|Reported Event|Continuation Treatment Period: Tralokinumab R/Q4W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30."
11324776|NCT03363854|EG004|Reported Event|Continuation Treatment Period: Tralokinumab NR/Q2W+TCS|"Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324777|NCT03363854|EG005|Reported Event|Continuation Treatment Period: Placebo NR/Tralokinumab Q2W+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30."
11324778|NCT03363854|EG006|Reported Event|Continuation Treatment Period: Placebo R/Placebo+TCS|"Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).~Participants were administered placebo Q2W from Week 16 to Week 30."
11324779|NCT03363854|EG007|Reported Event|Safety Follow-up|Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
11324780|NCT03363906|BG000|Baseline|Dulaglutide Test and Reference|Dulaglutide 4.5 mg administered SC in 3 prefilled syringes and 1 single dose pen in one of two study periods.
11324781|NCT03363906|FG000|Participant Flow|Sequence A Dulaglutide (Reference) Then Dulaglutide (Test)|Dulaglutide (4.5 milligram [mg]) administered subcutaneously (SC) in 3 prefilled syringes (PFS) in period 1 and then dulaglutide 4.5 mg administered SC in single dose pen (SDP) in period 2.
11324782|NCT03363906|FG001|Participant Flow|Sequence B Dulaglutide (Test) Then Dulaglutide (Reference)|Dulaglutide 4.5 mg administered SC in one (SDP) in period 1 and then Dulaglutide 4.5 mg administered SC (PFS) in period 2.
11324783|NCT03363906|OG000|Outcome|Dulaglutide (Reference)|Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods
11324784|NCT03363906|OG001|Outcome|Dulaglutide (Test)|Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods
11324785|NCT03363906|EG000|Reported Event|Dulaglutide (Reference)|Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods
11324786|NCT03363906|EG001|Reported Event|Dulaglutide (Test)|Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods
11333547|NCT03518125|OG005|Outcome|Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11333548|NCT03518125|OG000|Outcome|Age ≥ 66 Years: BioThrax (Day 1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333549|NCT03518125|EG000|Reported Event|Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333550|NCT03518125|EG001|Reported Event|Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)|Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
11333551|NCT03518125|EG002|Reported Event|Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5mL placebo
11333552|NCT03518125|EG003|Reported Event|Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)|Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
11333553|NCT03518125|EG004|Reported Event|Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)|Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
11333554|NCT03518125|EG005|Reported Event|Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)|Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
11333555|NCT03518658|BG000|Baseline|Evaluation Group|Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
11333556|NCT03518658|BG001|Baseline|Control Group (Historical)|Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
11333557|NCT03518658|BG002|Baseline|Total|Total of all reporting groups
11333558|NCT03518658|FG000|Participant Flow|Evaluation Group|"Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App~Evaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing"
11333559|NCT03518658|FG001|Participant Flow|Control Group (Historical)|Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
11333560|NCT03518658|OG000|Outcome|Evaluation Group|"Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App~Evaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing~Of the 257 enrolled patients, one patient was not available in CareLink database, 4 patients left evaluation early which resulted in data loss, 5 patients had no transmissions scheduled between 1 and 12 months, and 2 subjects had scheduled transmissions completed with another monitor than MyCareLink Heart App."
11333561|NCT03518658|OG001|Outcome|Control Group (Historical)|"Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)~Control Group: Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C)~The enrolled patients in the evaluation were compared to a historical control group from the Medtronic de-identified CareLink™ database. The following inclusion criteria were used to select the analysis group from CareLink comparable to the BlueSync™ field evaluation : a) > 18 years of age at implant; b) Patient activated (first received CareLink transmission with CareLink 2490 monitor) in CareLink from 1 Jan 2016 to 1 December 2018; c) Patient followed for at least one year after activation with a minimum of one scheduled transmission in this year, d) US patients, e) Patient did not perform transmission with another monitor for at least one year after activation."
11333562|NCT03518658|OG002|Outcome|Matched Control Group (Historical)|"Individual matching was performed using a greedy algorithm to create a matched control group comparable to the evaluation group. The matched control subjects were chosen from the historical control group with low power implantable devices and CareLink Monitor 2490 (excluding 2490C monitor).~Subjects were matched exactly based on age (± 2 years), gender, and number of device chambers (single, dual or triple). For the evaluation group patients' age at screening was used while for the historical control cohort, age at implant was available. A range of two years was chosen since age at implant and age at screening should be within two years for the evaluation group with most patients having zero years between screening and implant."
11333563|NCT03518658|OG000|Outcome|Evaluation Group|"Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App~Evaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing"
11333564|NCT03518658|EG000|Reported Event|Evaluation Group|Adverse events were not collected in the evaluation.
11333565|NCT03518658|EG001|Reported Event|Control Group (Historical)|Adverse events are not available from the control group since the data of these patients is extracted from the Medtronic de-identified CareLink™ database.
11333566|NCT03518840|BG000|Baseline|Sacroiliac Joint Belt|All patients receive an SIJ belt
11333567|NCT03518840|FG000|Participant Flow|Sacroiliac Joint Belt|All patients receive an SIJ belt
11333568|NCT03518840|OG000|Outcome|Baseline|All patients received an SIJ belt and had their ASLR score recorded at baseline
11333569|NCT03518840|OG001|Outcome|Week 4|At week 4, 52 women returning completed the ASLR assessment
11333570|NCT03518840|OG000|Outcome|Baseline|All patients received an SIJ belt and had their pain score recorded at baseline
11333571|NCT03518840|OG001|Outcome|Week 4|At week 4, 57 women completed the NRS assessment
11333572|NCT03518840|EG000|Reported Event|Sacroiliac Joint Belt|All patients receive an SIJ belt
11324787|NCT03364023|BG000|Baseline|Acute Ischemic Stroke Patients|Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
11324788|NCT03364023|FG000|Participant Flow|Acute Ischemic Stroke Patients|Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
11324789|NCT03364023|OG000|Outcome|Acute Ischemic Stroke Patients|Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
11324790|NCT03364023|EG000|Reported Event|Acute Ischemic Stroke Patients|Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
11324791|NCT03364049|BG000|Baseline|MK-7162 25 mg + Pembro|Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324792|NCT03364049|BG001|Baseline|MK-7162 50 mg + Pembro|Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324793|NCT03364049|BG002|Baseline|MK-7162 100 mg + Pembro|Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324794|NCT03364049|BG003|Baseline|MK-7162 200 mg + Pembro|Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324795|NCT03364049|BG004|Baseline|Total|Total of all reporting groups
11324796|NCT03364049|FG000|Participant Flow|MK-7162 25 mg + Pembrolizumab (Pembro)|Cycle 1: Participants receive MK-7162 25 mg via oral tablets once daily (QD) throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (every 3 weeks [Q3W]).
11324797|NCT03364049|FG001|Participant Flow|MK-7162 50 mg + Pembro|Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324798|NCT03364049|FG002|Participant Flow|MK-7162 100 mg + Pembro|Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324799|NCT03364049|FG003|Participant Flow|MK-7162 200 mg + Pembro|Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324800|NCT03364049|OG000|Outcome|MK-7162 25 mg + Pembro|Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324801|NCT03364049|OG001|Outcome|MK-7162 50 mg + Pembro|Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324802|NCT03364049|OG002|Outcome|MK-7162 100 mg + Pembro|Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324803|NCT03364049|OG003|Outcome|MK-7162 200 mg + Pembro|Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324804|NCT03364049|EG000|Reported Event|MK-7162 25mg + Pembro|Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324805|NCT03364049|EG001|Reported Event|MK-7162 50mg + Pembro|Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324806|NCT03364049|EG002|Reported Event|MK-7162 100mg + Pembro|Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324807|NCT03364049|EG003|Reported Event|MK-7162 200mg + Pembro|Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
11324808|NCT03364192|BG000|Baseline|Peer-delivered Whole Health Coaching|Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
11324809|NCT03364192|FG000|Participant Flow|Peer-delivered Whole Health Coaching|Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
11324810|NCT03364192|OG000|Outcome|Peer-delivered Whole Health Coaching|Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
11324811|NCT03364192|OG000|Outcome|Peer-delivered Whole Health Coaching|Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist.
11324812|NCT03364192|EG000|Reported Event|Peer-delivered Whole Health Coaching|Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist.
11324813|NCT03364309|BG000|Baseline|Placebo|Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
11324814|NCT03364309|BG001|Baseline|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
11324815|NCT03364309|BG002|Baseline|Ixekizumab 80mg Q2W|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
11324816|NCT03364309|BG003|Baseline|Total|Total of all reporting groups
11324817|NCT03364309|FG000|Participant Flow|PBO-Induction Dosing Period|Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during induction period.
11324818|NCT03364309|FG001|Participant Flow|IXE80Q4W-Induction Dosing Period|Participants received starting dose of 160 milligrams (mg) Ixekizumab (IXE) at week 0 followed by 80mg Ixekizumab once every four weeks (80Q4W) by subcutaneous injection during induction period
11324819|NCT03364309|FG002|Participant Flow|IXE80Q2W-Induction Dosing Period|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (80Q2W) by subcutaneous injection during induction period
11324820|NCT03364309|FG003|Participant Flow|IXE80Q4W(Res)/PBO-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324821|NCT03364309|FG004|Participant Flow|IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324822|NCT03364309|FG005|Participant Flow|IXE80Q2W(Res)/PBO-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324823|NCT03364309|FG006|Participant Flow|IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324824|NCT03364309|FG007|Participant Flow|PBO(Res)/PBO-Maintenance Dosing Period|Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324825|NCT03364309|FG008|Participant Flow|PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received placebo in induction period and classified as Non-responders (NonResp) received Ixekizumab 80 mg Q4W by SC injection in maintenance dosing period.
11324826|NCT03364309|FG009|Participant Flow|IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324827|NCT03364309|FG010|Participant Flow|IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324828|NCT03364309|FG011|Participant Flow|PBO(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
11324829|NCT03364309|FG012|Participant Flow|IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
11324830|NCT03364309|FG013|Participant Flow|IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
11324831|NCT03364309|FG014|Participant Flow|IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
11324832|NCT03364309|FG015|Participant Flow|IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
11324833|NCT03364309|FG016|Participant Flow|PBO-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324834|NCT03364309|FG017|Participant Flow|IXE80Q4W-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324835|NCT03364309|FG018|Participant Flow|IXE80Q2W-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324836|NCT03364309|OG000|Outcome|Placebo|Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
11324837|NCT03364309|OG001|Outcome|Ixekizumab 80mg Q4W|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
11324838|NCT03364309|OG002|Outcome|Ixekizumab 80mg Q2W|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
11324839|NCT03364309|EG000|Reported Event|PBO-Induction Dosing Period|Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
11324840|NCT03364309|EG001|Reported Event|IXE80Q4W-Induction Dosing Period|Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
11324841|NCT03364309|EG002|Reported Event|IXE80Q2W-Induction Dosing Period|Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
11324842|NCT03364309|EG003|Reported Event|IXE80Q4W(Res)/PBO-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324843|NCT03364309|EG004|Reported Event|IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324844|NCT03364309|EG005|Reported Event|IXE80Q2W(Res)/PBO-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324845|NCT03364309|EG006|Reported Event|IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324846|NCT03364309|EG007|Reported Event|PBO(Res)/PBO-Maintenance Dosing Period|Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
11324847|NCT03364309|EG008|Reported Event|PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received placebo in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324848|NCT03364309|EG009|Reported Event|IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324849|NCT03364309|EG010|Reported Event|IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period|Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
11324850|NCT03364309|EG011|Reported Event|PBO(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
11324851|NCT03364309|EG012|Reported Event|IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
10827895|NCT00112294|BG000|Baseline|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11324852|NCT03364309|EG013|Reported Event|IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
11324853|NCT03364309|EG014|Reported Event|IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
11324854|NCT03364309|EG015|Reported Event|IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period|Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
11324855|NCT03364309|EG016|Reported Event|PBO-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324856|NCT03364309|EG017|Reported Event|IXE80Q4W-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324857|NCT03364309|EG018|Reported Event|IXE80Q2W-Follow-up Period|Participants did not receive any intervention in post treatment follow-up period
11324858|NCT03364335|BG000|Baseline|Placebo|Placebo: Placebo
11324859|NCT03364335|BG001|Baseline|Leu Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID"
11324860|NCT03364335|BG002|Baseline|Leu Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID"
11324861|NCT03364335|BG003|Baseline|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID~Metformin: Metformin 500 mg BID"
11324862|NCT03364335|BG004|Baseline|Leu Met Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID~Metformin: Metformin 500 mg BID"
10827896|NCT00112294|BG001|Baseline|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11324863|NCT03364335|BG005|Baseline|Total|Total of all reporting groups
11324864|NCT03364335|FG000|Participant Flow|Placebo|Placebo: Placebo
11324865|NCT03364335|FG001|Participant Flow|Leu Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID"
11324866|NCT03364335|FG002|Participant Flow|Leu Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID"
11324867|NCT03364335|FG003|Participant Flow|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID~Metformin: Metformin 500 mg BID"
11324868|NCT03364335|FG004|Participant Flow|Leu Met Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID~Metformin: Metformin 500 mg BID"
11324869|NCT03364335|OG000|Outcome|Placebo|Placebo: Placebo
11324870|NCT03364335|OG001|Outcome|Leu Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID"
11324871|NCT03364335|OG002|Outcome|Leu Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID"
11324872|NCT03364335|OG003|Outcome|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID~Metformin: Metformin 500 mg BID"
11324873|NCT03364335|OG004|Outcome|Leu Met Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID~Metformin: Metformin 500 mg BID"
11324874|NCT03364335|EG000|Reported Event|Placebo|Placebo: Placebo
11324875|NCT03364335|EG001|Reported Event|Leu Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID"
11324876|NCT03364335|EG002|Reported Event|Leu Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID"
11324877|NCT03364335|EG003|Reported Event|Leu Met Sil 1.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID~Metformin: Metformin 500 mg BID"
11324878|NCT03364335|EG004|Reported Event|Leu Met Sil 4.0mg|"3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil~Leucine: 1100 mg BID~Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID~Metformin: Metformin 500 mg BID"
11324879|NCT03364608|BG000|Baseline|Overall Study|Safety Set
10827897|NCT00112294|BG002|Baseline|Total|Total of all reporting groups
11324880|NCT03364608|FG000|Participant Flow|Subjects|ITT Analysis set
11324881|NCT03364608|OG000|Outcome|AS MDI 180 µg|(2 actuations of 90 µg/actuation)
11324882|NCT03364608|OG001|Outcome|AS MDI 90 µg|(2 actuations of 45 µg/actuation)
11324883|NCT03364608|OG002|Outcome|Proventil 180 µg|(2 actuations of 90 µg/actuation)
11324884|NCT03364608|OG003|Outcome|Proventil 90 µg|(1 actuation of 90 µg/actuation)
11324885|NCT03364608|OG004|Outcome|Placebo MDI|(2 actuations)
11324886|NCT03364608|EG000|Reported Event|Placebo MDI|(2 actuations)
11324887|NCT03364608|EG001|Reported Event|AS MDI 90 µg|(2 actuations of 45 µg/actuation)
11324888|NCT03364608|EG002|Reported Event|Proventil 180 µg|(2 actuations of 90 µg/actuation)
11324889|NCT03364608|EG003|Reported Event|Proventil 90 µg|(1 actuation of 90 µg/actuation)
11324890|NCT03364608|EG004|Reported Event|• Proventil 180 µg|(2 actuations of 90 µg/actuation)
11324891|NCT03364738|BG000|Baseline|rhPTH(1-84)|Participants received rhPTH(1-84) (Natpara) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (EOT/ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining ACSC levels in the range of 2-2.25 mmol/L (8-9 mg/dL). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered.
11324892|NCT03364738|FG000|Participant Flow|rhPTH(1-84)|Participants received recombinant human parathyroid hormone (rhPTH) (1-84) (Natpara) 50 microgram (mcg), injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (end of treatment [EOT])/ early termination (ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8-9 milligrams per deciliter [mg/dL]). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was greater than (>) 2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered.
11324893|NCT03364738|OG000|Outcome|rhPTH(1-84)|Participants received rhPTH(1-84) (Natpara) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (EOT/ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining ACSC levels in the range of 2-2.25 mmol/L (8-9 mg/dL). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered.
11324894|NCT03364738|OG000|Outcome|rhPTH(1-84)|Participants received rhPTH(1-84) (Natpara) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (EOT])/ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining ACSC levels in the range of 2-2.25 mmol/L (8-9 mg/dL). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered.
11324895|NCT03364738|EG000|Reported Event|rhPTH(1-84)|Participants received rhPTH(1-84) (Natpara) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (EOT/ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining ACSC levels in the range of 2-2.25 mmol/L (8-9 mg/dL). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered.
11324896|NCT03364751|BG000|Baseline|IQOS|IQOS Product Use Category
11324897|NCT03364751|BG001|Baseline|Cigarette|Cigarette Product Use Category
11324898|NCT03364751|BG002|Baseline|Dual User|Dual User Product Use Category
11324899|NCT03364751|BG003|Baseline|Other|Other Product Use Category
11324900|NCT03364751|BG004|Baseline|Total|Total of all reporting groups
11324901|NCT03364751|FG000|Participant Flow|IQOS|"IQOS Product Use Category:~Subjects using over 30 HeatSticks, but less than 30 cigarettes monthly were classified as IQOS users (based on self-report)."
11324902|NCT03364751|FG001|Participant Flow|Cigarette|"Cigarette Product Use Category:~Monthly users of less than 30 HeatSticks, but over 30 cigarettes were classified as Cigarette users (based on self-report)."
11324903|NCT03364751|FG002|Participant Flow|Dual User|"Dual User Product Use Category:~Users of over 30 HeatSticks and over 30 cigarettes per month were classified as Dual User (based on self-report)."
11324904|NCT03364751|FG003|Participant Flow|Other|"Other Product Use Category:~All other use patterns were classified as Other (based on self-report)."
11324905|NCT03364751|OG000|Outcome|IQOS|IQOS Product Use Category
11324906|NCT03364751|OG001|Outcome|Cigarette|Cigarette Product Use Category
11324907|NCT03364751|OG002|Outcome|Dual User|Dual User Product Use Category
11324908|NCT03364751|OG000|Outcome|IQOS|IQOS Product Use Category - As Exposed Set
11324909|NCT03364751|OG001|Outcome|Cigarette|Cigarette Product Use Category - As Exposed Set
11324910|NCT03364751|OG002|Outcome|Dual User|Dual User Product Use Category - As Exposed Set
11324911|NCT03364751|OG003|Outcome|Other|Other Product Use Category
11324912|NCT03364751|OG003|Outcome|Other|Other Product Use Category - As Exposed Set
11324913|NCT03364751|EG000|Reported Event|IQOS|IQOS users (safety population)
11324914|NCT03364751|EG001|Reported Event|Cigarette|Cigarette users (safety population; includes 7 subjects who were enrolled but not randomized and were considered to be in the cigarette users group)
11324915|NCT03364751|EG002|Reported Event|Dual|Dual users (safety population)
11324916|NCT03364751|EG003|Reported Event|Other|Other users (safety population)
11324917|NCT03365011|BG000|Baseline|Placebo First|Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session.
11324918|NCT03365011|BG001|Baseline|Nitrous Oxide|Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
11324919|NCT03365011|BG002|Baseline|Total|Total of all reporting groups
11324920|NCT03365011|FG000|Participant Flow|Placebo First|Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session.
11324921|NCT03365011|FG001|Participant Flow|Nitrous Oxide First|Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
11324922|NCT03365011|OG000|Outcome|Placebo|Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
11324923|NCT03365011|OG001|Outcome|Nitrous Oxide|Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
11324924|NCT03365011|EG000|Reported Event|Placebo|"Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.~Participants are blinded to the order of interventions administered. Participants have been informed prior to consent that one session will contain the nitrous oxide gas mixture, and the other session will contain the placebo gas mixture.~Placebo gas for inhalation: Placebo gaseous mixture (50% nitrogen and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists."
11324925|NCT03365011|EG001|Reported Event|Nitrous Oxide|"Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.~Participants are blinded to the order of interventions administered. Participants have been informed prior to consent that one session will contain the nitrous oxide gas mixture, and the other session will contain the placebo gas mixture.~Nitrous oxide gas for inhalation: Nitrous oxide gaseous mixture (50% nitrous oxide and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists."
11324926|NCT03365154|BG000|Baseline|Treatment Group|"Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.~Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment: Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.~Balloon Angioplasty: Low pressure balloon angioplasty may be used following atherectomy"
11324927|NCT03365154|FG000|Participant Flow|Treatment Group|"Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.~Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment: Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.~Balloon Angioplasty: Low pressure balloon angioplasty may be used following atherectomy"
11324928|NCT03365154|OG000|Outcome|Treatment Group|"Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.~Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment: Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.~Balloon Angioplasty: Low pressure balloon angioplasty may be used following atherectomy"
11324929|NCT03365154|EG000|Reported Event|Treatment Group|"Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.~Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment: Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.~Balloon Angioplasty: Low pressure balloon angioplasty may be used following atherectomy"
11324930|NCT03365778|BG000|Baseline|Patient Educational Intervention Group|"Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.~Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided."
11324931|NCT03365778|BG001|Baseline|Usual Care Group|"Patients receive standard of care.~Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided."
11324932|NCT03365778|BG002|Baseline|Ophthalmologist Educational Intervention Group|General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT). No other personal information i.e. age, gender, ethnicity, race was provided by these participants.
11324933|NCT03365778|BG003|Baseline|Total|Total of all reporting groups
11324934|NCT03365778|FG000|Participant Flow|Patient Educational Intervention Group|"Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.~Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided."
11324935|NCT03365778|FG001|Participant Flow|Usual Care Group|"Patients receive standard of care.~Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided."
11324936|NCT03365778|FG002|Participant Flow|Ophthalmologist Educational Intervention Group|General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received an online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).
11324937|NCT03365778|OG000|Outcome|Educational Intervention Group|"Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.~Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided."
11324938|NCT03365778|OG001|Outcome|Usual Care Group|"Patients receive standard of care.~Usual care: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided."
11324939|NCT03365778|OG000|Outcome|Ophthalmologist Educational Intervention Group|"General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database receive online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).~Ophthalmologist Educational Intervention: Responses to online survey regarding beliefs and attitudes towards selective laser trabeculoplasty (SLT) before and after educational slide presentation were recorded and compared between physician specialty groups."
11324940|NCT03365778|EG000|Reported Event|Patient Educational Intervention Group|"Patients receive educational materials regarding selective laser trabeculoplasty (SLT) versus topical medication (ophthalmic eye drops) to lower eye pressure.~Educational intervention: Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided."
11324941|NCT03365778|EG001|Reported Event|Usual Care Group|Patients receive standard of care and will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
11324942|NCT03365778|EG002|Reported Event|Ophthalmologist Educational Intervention Group|General ophthalmologists, ophthalmology residents, and glaucoma specialists in the Wills Eye Hospital physician contact database received an online survey and educational slide presentation regarding selective laser trabeculoplasty (SLT).
11324943|NCT03365934|BG000|Baseline|All Randomized Subjects|All Randomized Subjects
11324944|NCT03365934|FG000|Participant Flow|All Randomized Subjects|All Randomized Subjects
11324945|NCT03365934|OG000|Outcome|Intact Uncovered Skin|Intact Uncovered Skin
11324946|NCT03365934|OG001|Outcome|Wounded Uncovered Skin|Wounded Uncovered Skin
11324947|NCT03365934|OG002|Outcome|Product #1|Product #1
11324948|NCT03365934|OG003|Outcome|Product #2|Product #2
11324949|NCT03365934|OG004|Outcome|Product #3|Product #3
11324950|NCT03365934|OG005|Outcome|Product #4|Product #4
11324951|NCT03365934|EG000|Reported Event|All Randomized Subjects|All Randomized Subjects
11324952|NCT03366207|BG000|Baseline|Ciprofloxacin|"Ciprofloxacin for the treatment of uncomplicated urinary tract infection~Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI."
11324953|NCT03366207|FG000|Participant Flow|Ciprofloxacin|"Ciprofloxacin for the treatment of uncomplicated urinary tract infection~Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI."
11324954|NCT03366207|OG000|Outcome|Ciprofloxacin|"Ciprofloxacin for the treatment of uncomplicated urinary tract infection~Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI."
11324955|NCT03366207|EG000|Reported Event|Ciprofloxacin|"Ciprofloxacin for the treatment of uncomplicated urinary tract infection~Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI."
11324956|NCT03366298|BG000|Baseline|Overall Cohort|Overall study cohort
11324957|NCT03366298|FG000|Participant Flow|Emerade 300 / Epipen 0.3mg / Emerade 500|"Visit 1: Emerade 300mcg then Epipen 0.3mg Visit 2: Emerade 500mcg~Epipen 0.3mg: Epipen 0.3mg auto-injector~Emerade 300mcg: Emerade 300mcg auto-injector~Emerade 500mcg: Emerade 500mcg auto-injector"
11324958|NCT03366298|FG001|Participant Flow|Epipen 0.3mg / Emerade 300 / Emerade 500|"Visit 1: Epipen 0.3mg then Emerade 300mcg Visit 2: Emerade 500mcg~Epipen 0.3mg: Epipen 0.3mg auto-injector~Emerade 300mcg: Emerade 300mcg auto-injector~Emerade 500mcg: Emerade 500mcg auto-injector"
11324959|NCT03366298|FG002|Participant Flow|Emerade 500 / Emerade 300 / Epipen 0.3mg|"Visit 1: Emerade 500mcg Visit 2: Emerade 300mcg then Epipen 0.3mg~Epipen 0.3mg: Epipen 0.3mg auto-injector~Emerade 300mcg: Emerade 300mcg auto-injector~Emerade 500mcg: Emerade 500mcg auto-injector"
11324960|NCT03366298|FG003|Participant Flow|Emerade 500 / Epipen 0.3mg / Emerade 300|"Visit 1: Emerade 500mcg Visit 2: Epipen 0.3mg then Emerade 300mcg~Epipen 0.3mg: Epipen 0.3mg auto-injector~Emerade 300mcg: Emerade 300mcg auto-injector~Emerade 500mcg: Emerade 500mcg auto-injector"
11324961|NCT03366298|OG000|Outcome|Emerade 300mcg Injection|Self-injection with Emerade 300mcg adrenaline auto-injector
11324962|NCT03366298|OG001|Outcome|Emerade 500mcg Injection|Self-injection with Emerade 500mcg adrenaline auto-injector
11324963|NCT03366298|OG002|Outcome|Epipen 0.3mg|Self-injection with Epipen 0.3mg adrenaline auto-injector
11324964|NCT03366298|EG000|Reported Event|Emerade 300mcg Injection|Self-injection with Emerade 300mcg adrenaline auto-injector
11324965|NCT03366298|EG001|Reported Event|Emerade 500mcg Injection|Self-injection with Emerade 500mcg adrenaline auto-injector
11324966|NCT03366298|EG002|Reported Event|Epipen 0.3mg|Self-injection with Epipen 0.3mg adrenaline auto-injector
11324967|NCT03367793|BG000|Baseline|Clinical, Then Metric #1, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324968|NCT03367793|BG001|Baseline|Clinical, Then Metric #2, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324969|NCT03367793|BG002|Baseline|Metric #1, Then Clinical, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324970|NCT03367793|BG003|Baseline|Metric #2, Then Clinical, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11333573|NCT03519087|BG000|Baseline|Interdisciplinary Evaluation|"Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.~Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant."
11333574|NCT03519087|BG001|Baseline|Standard Evaluation|Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
11333575|NCT03519087|BG002|Baseline|Total|Total of all reporting groups
11324971|NCT03367793|BG004|Baseline|Metric #1, Then Metric #2, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324972|NCT03367793|BG005|Baseline|Metric #2, Then Metric #1, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324973|NCT03367793|BG006|Baseline|Total|Total of all reporting groups
11324974|NCT03367793|FG000|Participant Flow|Clinical, Then Metric #1, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324975|NCT03367793|FG001|Participant Flow|Clinical, Then Metric #2, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11333576|NCT03519087|FG000|Participant Flow|Interdisciplinary Evaluation|"Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.~Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant."
10827898|NCT00112294|FG000|Participant Flow|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11324976|NCT03367793|FG002|Participant Flow|Metric #1, Then Clinical, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324977|NCT03367793|FG003|Participant Flow|Metric #2, Then Clinical, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324978|NCT03367793|FG004|Participant Flow|Metric #1, Then Metric #2, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324979|NCT03367793|FG005|Participant Flow|Metric #2, Then Metric #1, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11333577|NCT03519087|FG001|Participant Flow|Standard Evaluation|Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
11333578|NCT03519087|FG002|Participant Flow|Posture and Movement Training|Participants will receive six training sessions with a physical therapist over a 3-week period.
11333579|NCT03519087|FG003|Participant Flow|3-week Wait Period|Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.
11333580|NCT03519087|FG004|Participant Flow|Observational Arm|Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
11324980|NCT03367793|OG000|Outcome|Clinical, Then Metric #1, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324981|NCT03367793|OG001|Outcome|Clinical, Then Metric #2, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324982|NCT03367793|OG002|Outcome|Metric #1, Then Clinical, Then Metric #2|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324983|NCT03367793|OG003|Outcome|Metric #2, Then Clinical, Then Metric #1|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11333581|NCT03519087|OG000|Outcome|Interdisciplinary Evaluation|"Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.~Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant."
11333582|NCT03519087|OG001|Outcome|Standard Evaluation|Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
11333583|NCT03519087|OG002|Outcome|Posture and Movement Training|Participants will receive six training sessions with a physical therapist over a 3-week period.
11333584|NCT03519087|OG003|Outcome|3-week Wait Period|Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.
11324984|NCT03367793|OG004|Outcome|Metric #1, Then Metric #2, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324985|NCT03367793|OG005|Outcome|Metric #2, Then Metric #1, Then Clinical|"Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.~Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.~Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).~Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."
11324986|NCT03367793|EG000|Reported Event|Clinical|Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
11324987|NCT03367793|EG001|Reported Event|Metric #1|Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
11324988|NCT03367793|EG002|Reported Event|Metric #2|Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
11324989|NCT03368053|BG000|Baseline|GSKSB732461 Group|Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
11324990|NCT03368053|FG000|Participant Flow|GSKSB732461 Group|Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
11324991|NCT03368053|OG000|Outcome|GSKSB732461 Group|Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
10827899|NCT00112294|FG001|Participant Flow|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11324992|NCT03368053|EG000|Reported Event|GSKSB732461 Group|Healthy HIV uninfected volunteers who participated in study PRO HIV-002 between February 2003 and February 2005 and who were vaccinated with at least 3 doses of the GSKSB732461 vaccine candidate in the PRO-HIV-002 study.
11324993|NCT03368235|BG000|Baseline|AZD9567|Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks.
11324994|NCT03368235|BG001|Baseline|Prednisolone|Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks.
11324995|NCT03368235|BG002|Baseline|Total|Total of all reporting groups
11324996|NCT03368235|FG000|Participant Flow|AZD9567|Participants received AZD9567 40 milligram (mg) oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks.
11324997|NCT03368235|FG001|Participant Flow|Prednisolone|Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks.
11324998|NCT03368235|OG000|Outcome|AZD9567|Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks.
11324999|NCT03368235|OG001|Outcome|Prednisolone|Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks.
11325000|NCT03368235|EG000|Reported Event|AZD9567|Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks.
11325001|NCT03368235|EG001|Reported Event|Prednisolone|Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks.
11325002|NCT03368807|BG000|Baseline|Overall Study|Participants received prescribed insulin regimen suitable for their disease state using insulin lispro 100 U/mL injected via the pen. During the study, participants had their glucose monitored via the CGM device, which was blinded during Study Period 1 and unblinded during Study Period 2.
11325003|NCT03368807|FG000|Participant Flow|Study Period 1/Study Period 2|Participants with type 1 diabetes or type 2 diabetes received prescribed insulin regimen suitable for their disease state using insulin lispro 100 units per millilitre (U/mL) injected via the pen. During the study, participants had their glucose monitored via the continuous glucose monitoring (CGM) device, which was blinded during Study Period 1 and unblinded during Study Period 2.
11325004|NCT03368807|OG000|Outcome|Blinded CGM|Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed.
11325005|NCT03368807|OG000|Outcome|Unblinded CGM|Participants received Insulin lispro 100 U/mL injected via the pen and they were unblinded to CGM device recording as directed.
11325006|NCT03368807|EG000|Reported Event|Blinded CGM|Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed.
11325007|NCT03368807|EG001|Reported Event|Unblinded CGM|Participants received Insulin lispro 100 U/mL injected via the pen and they were unblinded to CGM device recording as directed.
11325008|NCT03368859|BG000|Baseline|ABT-165 Plus FOLFIRI|ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325009|NCT03368859|BG001|Baseline|Bevacizumab Plus FOLFIRI|Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325010|NCT03368859|BG002|Baseline|Total|Total of all reporting groups
11325011|NCT03368859|FG000|Participant Flow|ABT-165 Plus FOLFIRI|ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325012|NCT03368859|FG001|Participant Flow|Bevacizumab Plus FOLFIRI|Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325013|NCT03368859|OG000|Outcome|ABT-165 Plus FOLFIRI|ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325014|NCT03368859|OG001|Outcome|Bevacizumab Plus FOLFIRI|Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325015|NCT03368859|EG000|Reported Event|ABT-165 Plus FOLFIRI|ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325016|NCT03368859|EG001|Reported Event|Bevacizumab Plus FOLFIRI|Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
11325017|NCT03368898|BG000|Baseline|Estradiol Valerate|Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.
11325018|NCT03368898|BG001|Baseline|LNG-IUD|Women who were treated with Levonorgestrel Intrauterine Device LNG-IUD for Heavy Menstrual Bleeding for 4 years.
11325019|NCT03368898|BG002|Baseline|Micronized Progesterone|Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
11325020|NCT03368898|BG003|Baseline|Total|Total of all reporting groups
11325021|NCT03368898|FG000|Participant Flow|Estradiol Valerate|Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.
11325022|NCT03368898|FG001|Participant Flow|LNG-IUD|Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.
11325023|NCT03368898|FG002|Participant Flow|Micronized Progesterone|Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
11325024|NCT03368898|OG000|Outcome|Estradiol Valerate|Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.
11325025|NCT03368898|OG001|Outcome|LNG-IUD|Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.
11325026|NCT03368898|OG002|Outcome|Micronized Progesterone|Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
11325027|NCT03368898|EG000|Reported Event|Estradiol Valerate|Women who were treated with Estradiol valerate for Heavy Menstrual Bleeding for 3 months.
11325028|NCT03368898|EG001|Reported Event|LNG-IUD|Women who were treated with Levonorgestrel Intrauterine Device (LNG-IUD) for Heavy Menstrual Bleeding for 4 years.
11325029|NCT03368898|EG002|Reported Event|Micronized Progesterone|Women who were treated with Micronized Progesterone for Heavy Menstrual Bleeding for 3 months.
11325030|NCT03369158|BG000|Baseline|MySpine|"Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine~patient specific pedicle screw positioning guide~MUST pedicle screw"
11325031|NCT03369158|BG001|Baseline|Free Hand Technique|"Patients operated for spinal stabilization through standard free hand technique~Free hand technique pedicle screw positioning~MUST pedicle screw"
11325032|NCT03369158|BG002|Baseline|Total|Total of all reporting groups
11325033|NCT03369158|FG000|Participant Flow|MySpine|"Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine~patient specific pedicle screw positioning guide~MUST pedicle screw"
11325034|NCT03369158|FG001|Participant Flow|Free Hand Technique|"Patients operated for spinal stabilization through standard free hand technique~Free hand technique pedicle screw positioning~MUST pedicle screw"
11325035|NCT03369158|OG000|Outcome|MySpine|"Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine~patient specific pedicle screw positioning guide~MUST pedicle screw"
11325036|NCT03369158|OG001|Outcome|Free Hand Technique|"Patients operated for spinal stabilization through standard free hand technique~Free hand technique pedicle screw positioning~MUST pedicle screw"
11325037|NCT03369158|EG000|Reported Event|MySpine|"Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine~patient specific pedicle screw positioning guide~MUST pedicle screw"
11325038|NCT03369158|EG001|Reported Event|Free Hand Technique|"Patients operated for spinal stabilization through standard free hand technique~Free hand technique pedicle screw positioning~MUST pedicle screw"
11325039|NCT03369236|BG000|Baseline|Danicopan (Double-blind Treatment Period)|Danicopan was administered at a starting dose of 100 mg 3 times daily (TID) for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.
11325040|NCT03369236|BG001|Baseline|Placebo (Double-blind Treatment Period)|Placebo was administered TID during the 6-month treatment period.
11325041|NCT03369236|BG002|Baseline|Total|Total of all reporting groups
11325042|NCT03369236|FG000|Participant Flow|Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)|"Danicopan was administered at a starting dose of 100 milligrams (mg) 3 times daily (TID) for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.~All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID."
11325043|NCT03369236|FG001|Participant Flow|Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)|"Placebo was administered TID during the 6-month treatment period.~All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID."
11325044|NCT03369236|OG000|Outcome|Danicopan (Double-blind Treatment Period)|Danicopan was administered at a starting dose of 100 mg TID for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.
11325045|NCT03369236|OG001|Outcome|Placebo (Double-blind Treatment Period)|Placebo was administered TID during the 6-month treatment period.
11325046|NCT03369236|OG000|Outcome|Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period|"Danicopan was administered at a starting dose of 100 mg TID for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.~All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID."
11325047|NCT03369236|OG001|Outcome|Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)|Placebo was administered TID during the 6-month treatment period. All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID.
11325048|NCT03369236|OG002|Outcome|Total|All participants who received danicopan or placebo during the 6-month treatment period followed by danicopan 200 mg TID in the extension period.
11325049|NCT03369236|OG000|Outcome|Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)|"Danicopan was administered at a starting dose of 100 mg TID for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.~All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID."
11325050|NCT03369236|OG001|Outcome|Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)|"Placebo was administered TID during the 6-month treatment period.~All participants who completed the double-blind treatment period were enrolled in the open-label extension period and were to receive danicopan 200 mg TID."
11325051|NCT03369236|EG000|Reported Event|Danicopan (Double-blind Treatment Period)|Danicopan was administered at a starting dose of 100 mg TID for the first 2 weeks, then dosage was to be increased to 200 mg TID for the remainder of the 6-month treatment period.
11325052|NCT03369236|EG001|Reported Event|Placebo (Double-blind Treatment Period)|Placebo was administered TID during the 6-month treatment period.
11325053|NCT03369236|EG002|Reported Event|Danicopan (Open-label Extension Period)|All participants who received danicopan or placebo in the treatment period were to receive danicopan 200 mg TID during the open-label extension period.
11325054|NCT03369340|BG000|Baseline|Safety Population|The safety population comprised all enrolled subjects who were exposed to P3P during the study.
11325055|NCT03369340|FG000|Participant Flow|Product Sequence 1|"Subjects will follow a sequence of product exposure comprised of:~P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4"
11325056|NCT03369340|FG001|Participant Flow|Product Sequence 2|"Subjects will be follow a sequence of product exposure comprised of:~P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4"
11325057|NCT03369340|FG002|Participant Flow|Product Sequence 3|"Subjects will follow a sequence of product exposure comprised of:~P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4"
11325058|NCT03369340|FG003|Participant Flow|Product Sequence 4|"Subjects will follow a sequence of product exposure comprised of:~P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4"
11325059|NCT03369340|FG004|Participant Flow|Product Sequence 5|"Subjects will follow a sequence of product exposure comprised of:~P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4"
11325060|NCT03369340|FG005|Participant Flow|Product Sequence 6|"Subjects will follow a sequence of product exposure comprised of:~P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4"
11325061|NCT03369340|OG000|Outcome|P3P 1|2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
11325062|NCT03369340|OG001|Outcome|P3P 2|2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
11325063|NCT03369340|OG002|Outcome|P3P 3|1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
11325064|NCT03369340|OG003|Outcome|P3P 4|2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
11325065|NCT03369340|EG000|Reported Event|Safety Population (P3P 1)|Comprising enrolled subjects who were exposed to P3P 1 during the study.
11325066|NCT03369340|EG001|Reported Event|Safety Population (P3P 2)|Comprising enrolled subjects who were exposed to P3P 2 during the study.
11325067|NCT03369340|EG002|Reported Event|Safety Population (P3P 3)|Comprising enrolled subjects who were exposed to P3P 3 during the study.
11325068|NCT03369340|EG003|Reported Event|Safety Population (P3P 4)|Comprising enrolled subjects who were exposed to P3P 4 during the study.
11333585|NCT03519087|OG004|Outcome|Observational Arm|Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
11333586|NCT03519087|OG000|Outcome|Pre-enrollment|The orthopaedic surgeons (2) and physical therapist (1) who participated as study clinicians were interviewed regarding their opinions of the interdisciplinary evaluation.
11325069|NCT03369418|BG000|Baseline|Active|"Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia"
11325070|NCT03369418|BG001|Baseline|Inactive|"Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive treatment one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive."
11325071|NCT03369418|BG002|Baseline|Total|Total of all reporting groups
11325072|NCT03369418|FG000|Participant Flow|Active|"Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia"
11325073|NCT03369418|FG001|Participant Flow|Inactive|"Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive treatment one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive."
11325074|NCT03369418|OG000|Outcome|Active|"Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia"
11325075|NCT03369418|OG001|Outcome|Inactive|"Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive treatment one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive."
11325076|NCT03369418|EG000|Reported Event|Active|"Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia"
11325077|NCT03369418|EG001|Reported Event|Inactive|"Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive treatment one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.~Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive."
11325078|NCT03369704|BG000|Baseline|Omalizumab|Omalizumab administered subcutaneously for 12 weeks
11325079|NCT03369704|BG001|Baseline|Placebo|Placebo administered subcutaneously for 12 weeks
11325080|NCT03369704|BG002|Baseline|Total|Total of all reporting groups
11325081|NCT03369704|FG000|Participant Flow|Omalizumab|Omalizumab administered subcutaneously for 12 weeks
11325082|NCT03369704|FG001|Participant Flow|Placebo|Placebo administered subcutaneously for 12 weeks
11325083|NCT03369704|OG000|Outcome|Omalizumab|Omalizumab administered subcutaneously for 12 weeks
11325084|NCT03369704|OG001|Outcome|Placebo|Placebo administered subcutaneously for 12 weeks
11325085|NCT03369704|EG000|Reported Event|IGE025|Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks
11325086|NCT03369704|EG001|Reported Event|Placebo|Placebo administered subcutaneously for 12 weeks
11325087|NCT03369756|BG000|Baseline|Prontosan Solution and Gel|"Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period~Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel"
11325088|NCT03369756|FG000|Participant Flow|Prontosan Solution and Gel|"Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period~Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel"
11325089|NCT03369756|OG000|Outcome|Prontosan Solution and Gel|"Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period~Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel"
11325090|NCT03369756|EG000|Reported Event|Prontosan Solution and Gel|"Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period~Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel"
11325091|NCT03369951|BG000|Baseline|Minocin® IV|"200 mg minocycline hydrochloride IV infusion over approximately 60 minutes~Minocycline: Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms."
11325092|NCT03369951|FG000|Participant Flow|Minocin® IV|"200 mg minocycline hydrochloride IV infusion over approximately 60 minutes~Minocycline: Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms."
11325093|NCT03369951|OG000|Outcome|Minocin® IV|"200 mg minocycline hydrochloride IV infusion over approximately 60 minutes~Minocycline: Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms."
11325094|NCT03369951|EG000|Reported Event|Minocin® IV|"200 mg minocycline hydrochloride IV infusion over approximately 60 minutes~Minocycline: Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms."
11325095|NCT03370042|BG000|Baseline|SCPF + FGG|semilunar coronally positioned flap with free gingival graft
11325096|NCT03370042|BG001|Baseline|SCPF|semilunar coronally positioned flap alone
11325097|NCT03370042|BG002|Baseline|Total|Total of all reporting groups
11325098|NCT03370042|FG000|Participant Flow|SCPF + FGG|"semilunar coronally positioned flap with free gingival graft~semilunar coronally positioned flap with free gingival graft"
11325099|NCT03370042|FG001|Participant Flow|SCPF|"semilunar coronally positioned flap alone~semilunar coronally positioned flap alone"
11325100|NCT03370042|OG000|Outcome|SCPF + FGG|"semilunar coronally positioned flap with free gingival graft~semilunar coronally positioned flap with free gingival graft"
11325101|NCT03370042|OG001|Outcome|SCPF|"semilunar coronally positioned flap alone~semilunar coronally positioned flap alone"
11325102|NCT03370042|OG000|Outcome|SCPF + FGG|semilunar coronally positioned flap with free gingival graft
11325103|NCT03370042|OG001|Outcome|SCPF|semilunar coronally positioned flap alone
11325104|NCT03370042|OG000|Outcome|SCPF + FGG|semilunar coronally positioned flap with free gingival graft for root coverage
11325105|NCT03370042|OG001|Outcome|SCPF|semilunar coronally positioned flap alone without free gingival graft for root coverage
11325106|NCT03370042|EG000|Reported Event|SCPF + FGG|semilunar coronally positioned flap with free gingival graft
11325107|NCT03370042|EG001|Reported Event|SCPF|semilunar coronally positioned flap alone
11325108|NCT03370289|BG000|Baseline|Overall (BLB-750 Vaccine)|Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
11325109|NCT03370289|FG000|Participant Flow|Overall (BLB-750 Vaccine)|Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
11325110|NCT03370289|OG000|Outcome|Overall (BLB-750 Vaccine)|Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
11325111|NCT03370289|EG000|Reported Event|Overall (BLB-750 Vaccine)|Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
11325112|NCT03370302|BG000|Baseline|Dose Escalation, Daily Dosing Arm: TAK-228 2 mg|TAK-228 2 milligram (mg), milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325113|NCT03370302|BG001|Baseline|Dose Escalation, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325114|NCT03370302|BG002|Baseline|Dose Escalation, Daily Dosing Arm: TAK-228 4 mg|TAK-228 4 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325115|NCT03370302|BG003|Baseline|Dose Expansion, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in each 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325116|NCT03370302|BG004|Baseline|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325117|NCT03370302|BG005|Baseline|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325118|NCT03370302|BG006|Baseline|Total|Total of all reporting groups
11325119|NCT03370302|FG000|Participant Flow|Dose Escalation, Daily Dosing Arm: TAK-228 2 mg|TAK-228 2 milligram (mg), milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325120|NCT03370302|FG001|Participant Flow|Dose Escalation, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325121|NCT03370302|FG002|Participant Flow|Dose Escalation, Daily Dosing Arm: TAK-228 4 mg|TAK-228 4 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325122|NCT03370302|FG003|Participant Flow|Dose Expansion, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in each 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325123|NCT03370302|FG004|Participant Flow|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325124|NCT03370302|FG005|Participant Flow|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325125|NCT03370302|OG000|Outcome|Dose Escalation, Daily Dosing Arm: TAK-228 2 mg|TAK-228 2 milligram (mg), milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325126|NCT03370302|OG001|Outcome|Dose Escalation, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325127|NCT03370302|OG002|Outcome|Dose Escalation, Daily Dosing Arm: TAK-228 4 mg|TAK-228 4 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325128|NCT03370302|OG003|Outcome|Dose Expansion, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in each 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325129|NCT03370302|OG004|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325130|NCT03370302|OG005|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325131|NCT03370302|OG003|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325132|NCT03370302|OG004|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325133|NCT03370302|OG000|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325134|NCT03370302|OG001|Outcome|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325135|NCT03370302|EG000|Reported Event|Dose Escalation, Daily Dosing Arm: TAK-228 2 mg|TAK-228 2 milligram (mg), milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325136|NCT03370302|EG001|Reported Event|Dose Escalation, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325137|NCT03370302|EG002|Reported Event|Dose Escalation, Daily Dosing Arm: TAK-228 4 mg|TAK-228 4 mg, milled capsule, orally, once daily, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325138|NCT03370302|EG003|Reported Event|Dose Expansion, Daily Dosing Arm: TAK-228 3 mg|TAK-228 3 mg, milled capsule, orally, once daily, on an empty stomach in each 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325139|NCT03370302|EG004|Reported Event|Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg|TAK-228 20 mg, milled capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325140|NCT03370302|EG005|Reported Event|Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg|TAK-228 30 mg milled, capsule, orally, once weekly, on an empty stomach in a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
11325141|NCT03370419|BG000|Baseline|The Pick Two to Stick To|"Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation.~The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.~Control: usual care"
11325142|NCT03370419|FG000|Participant Flow|The Pick Two to Stick To|"Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation.~The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.~Control: usual care"
11325143|NCT03370419|OG000|Outcome|The Pick Two to Stick To|"Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation.~The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.~Control: usual care"
11325144|NCT03370419|EG000|Reported Event|The Pick Two to Stick To|"Participants are asked to participate in five health-coaching sessions and to return in Week 20 for follow-up data collection. The initial face-to-face coaching session lasts approximately 90 minutes with subsequent telephone sessions lasting approximately 20 minutes. Coaching sessions will include education about MetS, weight loss, dietary and physical activity recommendations, and the principles of habit development, guidance in forming implementation intentions for each self-selected habit, and identifying routines and contextual cues that could be modified to support habit development Coaching sessions are augmented with a participant workbook. Participants' also receive individually tailored study text messages to maintain their motivation.~The Pick Two to Stick To Habit Development Intervention: Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.~Control: usual care"
11325145|NCT03370471|BG000|Baseline|Healthy Older Adults|"Participants complete all four study interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325146|NCT03370471|BG001|Baseline|Individuals With Aphasia|"Participants complete all four study interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325147|NCT03370471|BG002|Baseline|Total|Total of all reporting groups
11325148|NCT03370471|FG000|Participant Flow|Healthy Older Adults|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325149|NCT03370471|FG001|Participant Flow|Individuals With Aphasia|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325150|NCT03370471|OG000|Outcome|Healthy Older Adults|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325151|NCT03370471|OG001|Outcome|Individuals With Aphasia|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325152|NCT03370471|OG000|Outcome|Healthy Older Adults|Participants complete all four interventions Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning) Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning) Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning) Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
11325153|NCT03370471|OG001|Outcome|Individuals With Aphasia|Participants complete all four interventions Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning) Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning) Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning) Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
11325154|NCT03370471|EG000|Reported Event|Healthy Older Adults|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325155|NCT03370471|EG001|Reported Event|Individuals With Aphasia|"Participants complete all four interventions~Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)~Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)~Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)~Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)"
11325156|NCT03370770|BG000|Baseline|Patients With EGFR Mutation-positive NSCLC|Patients with EGFR mutation-positive NSCLC with acquired T790M mutation at least 10 months prior to data entry, and who were treated with afatinib (Gi[l]otrif®) (50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi[l]otrif®)) in the first-line line treatment followed by second-line osimertinib treatment (80 milligram (mg) or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
11325157|NCT03370770|FG000|Participant Flow|Patients With EGFR Mutation-positive NSCLC|Patients with EGFR mutation-positive NSCLC with acquired T790M mutation at least 10 months prior to data entry, and who were treated with afatinib (Gi[l]otrif®) (50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi[l]otrif®)) in the first-line line treatment followed by second-line osimertinib treatment (80 milligram (mg) or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
11325158|NCT03370770|OG000|Outcome|Patients With EGFR Mutation-positive NSCLC|Patients with EGFR mutation-positive NSCLC with acquired T790M mutation at least 10 months prior to data entry, and who were treated with afatinib (Gi[l]otrif®) (50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi[l]otrif®)) in the first-line line treatment followed by second-line osimertinib treatment (80 milligram (mg) or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
11325159|NCT03370770|EG000|Reported Event|Patients With EGFR Mutation-positive NSCLC|Patients with EGFR mutation-positive NSCLC with acquired T790M mutation at least 10 months prior to data entry, and who were treated with afatinib (Gi[l]otrif®) (50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi[l]otrif®)) in the first-line line treatment followed by second-line osimertinib treatment (80 milligram (mg) or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
11325160|NCT03371355|BG000|Baseline|Pooled Placebo|Participants from each cohort received placebo at a dose-matched volume of study drug, SC.
11325161|NCT03371355|BG001|Baseline|Cohort B: ISIS 703802, 40 mg Q4W|Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses.
11325162|NCT03371355|BG002|Baseline|Cohort C: ISIS 703802, 80 mg Q4W|Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
11325163|NCT03371355|BG003|Baseline|Cohort A: ISIS 703802, 20 mg QW|Participants received ISIS 703802, 20 mg SC once every week for 26 doses.
11325164|NCT03371355|BG004|Baseline|Total|Total of all reporting groups
11325165|NCT03371355|FG000|Participant Flow|Pooled Placebo|Participants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC).
11325166|NCT03371355|FG001|Participant Flow|Cohort B: ISIS 703802, 40 mg Q4W|Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
11325167|NCT03371355|FG002|Participant Flow|Cohort C: ISIS 703802, 80 mg Q4W|Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
11325168|NCT03371355|FG003|Participant Flow|Cohort A: ISIS 703802, 20 mg QW|Participants received ISIS 703802, 20 mg SC once every week for 26 doses.
11325169|NCT03371355|OG000|Outcome|Pooled Placebo|Participants from each cohort received placebo at a dose-matched volume of study drug, SC.
11325170|NCT03371355|OG001|Outcome|Cohort B: ISIS 703802, 40 mg Q4W|Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses.
11325171|NCT03371355|OG002|Outcome|Cohort C: ISIS 703802, 80 mg Q4W|Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
11325172|NCT03371355|OG003|Outcome|Cohort A: ISIS 703802, 20 mg QW|Participants received ISIS 703802, 20 mg SC once every week for 26 doses.
11325173|NCT03371355|OG001|Outcome|Cohort B: ISIS 703802, 40 mg Q4W|Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
11325174|NCT03371355|OG003|Outcome|Cohort A: ISIS 703802, 20 mg QW|Participants received ISIS 703802, 20 mg once every week for 26 doses.
11325175|NCT03371355|OG003|Outcome|Cohort A: ISIS 703802, 20 mg Q4W|Participants received ISIS 703802, 20 mg SC once every week for 26 doses.
11325176|NCT03371355|OG003|Outcome|Cohort A: ISIS 703802, 20 mg Q4W|Participants received ISIS 703802, 20 mg once every week for 26 doses.
11325177|NCT03371355|EG000|Reported Event|Pooled Placebo|Participants from each cohort received placebo at a dose-matched volume of study drug, SC.
11325178|NCT03371355|EG001|Reported Event|Cohort B: ISIS 703802, 40 mg Q4W|Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
11325179|NCT03371355|EG002|Reported Event|Cohort C: ISIS 703802, 80 mg Q4W|Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
11325180|NCT03371355|EG003|Reported Event|Cohort A: ISIS 703802, 20 mg QW|Participants received ISIS 703802, 20 mg once every week for 26 doses.
11325181|NCT03371381|BG000|Baseline|Phase 1b: JNJ-64041757+ Nivolumab|Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
11325182|NCT03371381|FG000|Participant Flow|Phase 1b: JNJ-64041757+ Nivolumab|Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
11325183|NCT03371381|OG000|Outcome|Phase 1b: JNJ-64041757+ Nivolumab|Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
11325184|NCT03371381|EG000|Reported Event|Phase 1b: JNJ-64041757+ Nivolumab|Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
11325185|NCT03371459|BG000|Baseline|mITT Population|The mITT Analysis Set is defined as a subset of the ITT Analysis Set including subjects who received treatment and had post-treatment efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations are determined prior to database lock in a blinded fashion and excluded per the statistical protocol deviation plan. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment are excluded from the affected periods
11325186|NCT03371459|FG000|Participant Flow|Treatment Sequence A|AS MDI 90 ug then Proventil 90 ug
11325187|NCT03371459|FG001|Participant Flow|Treatment Sequence B|Proventil 90 ug then AS MDI 90 ug
11325188|NCT03371459|OG000|Outcome|AS MDI|AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
11325189|NCT03371459|OG001|Outcome|Proventil|Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
11325190|NCT03371459|EG000|Reported Event|AS MDI|AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
11325191|NCT03371459|EG001|Reported Event|Proventil|Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
11325192|NCT03371732|BG000|Baseline|Arm 1|"Arm 1: Motivational Intervention group~Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention."
11325193|NCT03371732|BG001|Baseline|Arm 2|"Arm 2 : Educational advises group~Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption."
11325194|NCT03371732|BG002|Baseline|Total|Total of all reporting groups
11325195|NCT03371732|FG000|Participant Flow|Arm 1|"Arm 1: Motivational Intervention group~Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention."
11325196|NCT03371732|FG001|Participant Flow|Arm 2|"Arm 2: Educational advises group~Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption."
11325197|NCT03371732|OG000|Outcome|Arm 1|"Arm 1: Motivational Intervention group~Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention."
11325198|NCT03371732|OG001|Outcome|Arm 2|"Arm 2: Educational advises group~Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption."
11325199|NCT03371732|OG001|Outcome|Arm 2|"Arm 2 : Educational advises group~Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption."
11325200|NCT03371732|OG000|Outcome|Arm 1|"Arm 1 : Motivational Intervention group~Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention."
11325201|NCT03371732|EG000|Reported Event|Groupe 1|"G1 : Motivational Intervention group~Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention."
11325202|NCT03371732|EG001|Reported Event|Groupe 2|"G2 : Educational advises group~Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption."
11325203|NCT03371836|BG000|Baseline|Open Label Single Treatment Arm|"open label~Clobazam: Clobazam is used as an adjunct medicine for all participants."
11325204|NCT03371836|FG000|Participant Flow|Clobazam|"open label single treatment arm~Clobazam is used as an adjunct medicine for all participants."
11325205|NCT03371836|OG000|Outcome|Clobazam|"open label single treatment arm~Clobazam is used as an adjunct medicine for all participants."
11325206|NCT03371836|EG000|Reported Event|Open Label Single Treatment Arm|"open label~Clobazam: Clobazam is used as an adjunct medicine for all participants."
11325207|NCT03372083|BG000|Baseline|Deferasirox|Crushed deferasirox (ICL670) FCT for oral use daily. Deferasirox FCT dosing was based on subject's weight.
11325208|NCT03372083|FG000|Participant Flow|Deferasirox|Crushed deferasirox (ICL670) FCT for oral use daily. Deferasirox FCT dosing was based on subject's weight.
11325209|NCT03372083|OG000|Outcome|Deferasirox|Crushed deferasirox (ICL670) FCT for oral use daily. Deferasirox FCT dosing was based on subject's weight.
11325210|NCT03372083|EG000|Reported Event|Deferasirox|Crushed deferasirox (ICL670) FCT for oral use daily. Deferasirox FCT dosing was based on subject's weight.
11325211|NCT03372096|BG000|Baseline|All Patients|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325212|NCT03372096|FG000|Participant Flow|All Patients|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325213|NCT03372096|OG000|Outcome|Patients With 6 Month Follow up|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325214|NCT03372096|OG000|Outcome|Patients With 6 Month Follow up Data|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325215|NCT03372096|OG000|Outcome|All Patients With 6 Month Uroflow Testing|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325216|NCT03372096|OG000|Outcome|All Patients|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325217|NCT03372096|EG000|Reported Event|All Patients|"Patients will receive the Prostatic Artery Embolization procedure.~Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."
11325218|NCT03372369|BG000|Baseline|CDC Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.~View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness."
11325219|NCT03372369|BG001|Baseline|Patient-Centered Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.~View Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating."
11325220|NCT03372369|BG002|Baseline|Total|Total of all reporting groups
11325221|NCT03372369|FG000|Participant Flow|CDC Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.~View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness."
11325222|NCT03372369|FG001|Participant Flow|Patient-Centered Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.~View Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating."
11325223|NCT03372369|OG000|Outcome|CDC Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.~View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness."
11325224|NCT03372369|OG001|Outcome|Patient-Centered Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.~View Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating."
11325225|NCT03372369|EG000|Reported Event|CDC Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.~View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness."
11325226|NCT03372369|EG001|Reported Event|Patient-Centered Poster|"After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.~View Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating."
11325227|NCT03372382|BG000|Baseline|Ibuprofen Plus Acetaminophen|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen~Ibuprofen: NSAID~Acetaminophen: analgesic~85 women recruited into this study arm"
11325228|NCT03372382|BG001|Baseline|Ibuprofen Plus Acetaminophen/Hydrocodone|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone~Ibuprofen: NSAID~Acetaminophen plus hydrocodone: Opioid~85 women recruited into this study arm"
11325229|NCT03372382|BG002|Baseline|Total|Total of all reporting groups
11325230|NCT03372382|FG000|Participant Flow|Ibuprofen Plus Acetaminophen|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen~Ibuprofen: NSAID~Acetaminophen: analgesic~85 women recruited into this study arm"
11325231|NCT03372382|FG001|Participant Flow|Ibuprofen Plus Acetaminophen/Hydrocodone|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone~Ibuprofen: NSAID~Acetaminophen plus hydrocodone: Opioid~85 women recruited into this study arm"
11325232|NCT03372382|OG000|Outcome|Ibuprofen Plus Acetaminophen|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen~Ibuprofen: NSAID~Acetaminophen: analgesic"
11325233|NCT03372382|OG001|Outcome|Ibuprofen Plus Acetaminophen/Hydrocodone|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)~Ibuprofen: NSAID~Norco: acetaminophen plus opioid"
11325234|NCT03372382|OG000|Outcome|Ibuprofen Plus Acetaminophen|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen~Ibuprofen: NSAID~Acetaminophen: analgesic~85 women recruited into this study arm"
11325235|NCT03372382|OG001|Outcome|Ibuprofen Plus Acetaminophen/Hydrocodone|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone~Ibuprofen: NSAID~Acetaminophen plus hydrocodone: Opioid~85 women recruited into this study arm"
11325236|NCT03372382|EG000|Reported Event|Ibuprofen Plus Acetaminophen|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen~Ibuprofen: NSAID~Acetaminophen: analgesic~85 women recruited into this study arm"
11325237|NCT03372382|EG001|Reported Event|Ibuprofen Plus Acetaminophen/Hydrocodone|"women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone~Ibuprofen: NSAID~Acetaminophen plus hydrocodone: Opioid~85 women recruited into this study arm"
11325238|NCT03372434|BG000|Baseline|Model ZFR00|Investigational IOL implanted in the first eye
11325239|NCT03372434|BG001|Baseline|Model ZLB00|Control IOL implanted in the first eye
11325240|NCT03372434|BG002|Baseline|Model ZYR00|Investigational IOL implanted in the first eye
11325241|NCT03372434|BG003|Baseline|Total|Total of all reporting groups
11325242|NCT03372434|FG000|Participant Flow|Model ZFR00|Investigational IOL implanted in the first eye
11325243|NCT03372434|FG001|Participant Flow|Model ZLB00|Control IOL implanted in the first eye
11325244|NCT03372434|FG002|Participant Flow|Model ZYR00|Investigational IOL implanted in the first eye
11325245|NCT03372434|OG000|Outcome|Model ZFR00|Investigational IOL implanted in the first eye
11325246|NCT03372434|OG001|Outcome|Model ZLB00|Control IOL implanted in the first eye
11325247|NCT03372434|OG002|Outcome|Model ZYR00|Investigational IOL implanted in the first eye
11325248|NCT03372434|EG000|Reported Event|Model ZFR00|Investigational IOL device
11325249|NCT03372434|EG001|Reported Event|Model ZLB00|Control IOL Device
11325250|NCT03372434|EG002|Reported Event|Model ZYR00|Investigational IOL Device
11325251|NCT03372551|BG000|Baseline|Somofilcon A 1 Day Test vs Control Contact Lens|"Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair.~somofilcon A 1 day test lens: Test / Contact lens~somofilcon A 1 day control lens: Test / Contact lens"
11325252|NCT03372551|FG000|Participant Flow|Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens|"Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325253|NCT03372551|FG001|Participant Flow|Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens|"Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325254|NCT03372551|OG000|Outcome|Somofilcon A 1 Day Test Lens|"Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325255|NCT03372551|OG001|Outcome|Somofilcon A 1 Day Control Lens|"Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325256|NCT03372551|OG000|Outcome|Somofilcon A 1 Day Test / Control Contact Lens|"Each subjects randomized to wear either the somofilcon A 1 day test or somofilcon A 1 day control as a matched pair and cross over to second matched pair.~somofilcon A 1 day test lens: Test / Contact lens~somofilcon A 1 day control lens: Test / Contact lens"
11325257|NCT03372551|OG000|Outcome|Somofilcon A 1 Day Test Lens Dispense|"Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325258|NCT03372551|OG001|Outcome|Somofilcon A 1 Day Test Lens 1 Week|"Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325259|NCT03372551|OG002|Outcome|Somofilcon A 1 Day Control Lens Dispense|"Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325260|NCT03372551|OG003|Outcome|Somofilcon A 1 Day Control Lens 1 Week|"Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325261|NCT03372551|OG000|Outcome|Somofilcon 1 Day Test Lens: Vision Quality/Clarity During Day|"Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325262|NCT03372551|OG001|Outcome|Somofilcon A Control Lens: Vision Quality/Clarity During Day|"Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325263|NCT03372551|EG000|Reported Event|Somofilcon A 1 Day Test Lens|"Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325264|NCT03372551|EG001|Reported Event|Somofilcon A 1 Day Control Lens|"Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.~somofilcon A 1 day test lens: Contact lens~somofilcon A 1 day control lens: Contact lens"
11325265|NCT03372603|BG000|Baseline|All Study Participants|All participants who were randomized to either of the two treatment sequences Placebo/GSK2798745 and GSK2798745/Placebo and received GSK2798745 and placebo in either Treatment period 1 or 2 were included. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325266|NCT03372603|FG000|Participant Flow|Placebo/GSK2798745|Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325267|NCT03372603|FG001|Participant Flow|GSK2798745/Placebo|Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325268|NCT03372603|OG000|Outcome|Placebo|Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325269|NCT03372603|OG001|Outcome|GSK2798745|Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11333587|NCT03519087|OG001|Outcome|Post-enrollment|The orthopaedic surgeons (2) and physical therapist (1) who participated as study clinicians were interviewed regarding their opinions of the interdisciplinary evaluation.
11325270|NCT03372603|EG000|Reported Event|Placebo|Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325271|NCT03372603|EG001|Reported Event|GSK2798745|Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
11325272|NCT03372928|BG000|Baseline|All Study Participants|All participants were randomized to receive all interventions.
11325273|NCT03372928|FG000|Participant Flow|Low EAA First, Then High EAA|Participants received EAA provided relative to body mass at a standard dose (0.10 g/kg; LOW)) during energy deprivation first, then received EAA provided relative to body mass at a high dose (0.3 g/kg; HIGH) during energy deprivation.
11325274|NCT03372928|FG001|Participant Flow|High EAA First, Then Low EAA|Participants received EAA provided relative to body mass at a high dose (0.30 g/kg; HIGH) during energy deprivation first, then received EAA provided relative to body mass at a low dose (0.1 g/kg; LOW) during energy deprivation.
11325275|NCT03372928|OG000|Outcome|Standard EAA Dose|"EAA dose provided at 0.10 g/kg body mass~Standard EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation"
11325276|NCT03372928|OG001|Outcome|High EAA Dose|"EAA dose provided at 0.30 g/kg body mass~High EAA: EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation"
11325277|NCT03372928|OG000|Outcome|Standard EAA|"Arm:~EAA dose provided at 0.10 g/kg body mass~Standard EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation"
11325278|NCT03372928|OG001|Outcome|High EAA|"Arm:~EAA dose provided at 0.30 g/kg body mass~High EAA: EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation"
11325279|NCT03372928|OG000|Outcome|Standard EAA|"Arm:~EAA dose provided at 0.10 g/kg body mass~Low EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation"
11325280|NCT03372928|EG000|Reported Event|Low EAA First, Then High EAA: Low EAA Treatment|"EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention.~Low EAA Treatment Period"
11325281|NCT03372928|EG001|Reported Event|High EAA First, Then Low EAA: Low EAA Treatment|"EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention.~Low EAA Treatment Period"
11325282|NCT03372928|EG002|Reported Event|Low EAA First, Then High EAA: High EAA Treatment|"EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention.~High EAA Treatment Period"
11325283|NCT03372928|EG003|Reported Event|High EAA First, Then Low EAA: High EAA Treatment|"EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention.~High EAA Treatment Period"
11325284|NCT03373162|BG000|Baseline|Pre-Post|"Participants will receive MRI scans pre and post-Botox injection~onabotulinumtoxinA: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA ."
11325285|NCT03373162|FG000|Participant Flow|MRI Scans Pre and Post-Botox Injections|"Participants will receive MRI scans pre and post-Botox injection~onabotulinumtoxinA: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA ."
11325286|NCT03373162|OG000|Outcome|MRI Scans Pre and Post-Botox Injection|"Participants will receive MRI scans pre and post-Botox injection~onabotulinumtoxinA: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA ."
11325287|NCT03373162|OG000|Outcome|MRI Scans Pre and Post-Botox Injections|"Participants will receive MRI scans pre and post-Botox injection~onabotulinumtoxinA: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA ."
11325288|NCT03373162|EG000|Reported Event|Pre-Post|"Participants will receive MRI scans pre and post-Botox injection~onabotulinumtoxinA: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA ."
11325289|NCT03373240|BG000|Baseline|TAU Plus Cognitive Remediation Program|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.~TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes."
11325290|NCT03373240|BG001|Baseline|TAU Plus Control Tasks|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.~TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games."
11325291|NCT03373240|BG002|Baseline|Total|Total of all reporting groups
11325292|NCT03373240|FG000|Participant Flow|TAU Plus Cognitive Remediation Program|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.~TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes."
11333588|NCT03519087|OG000|Outcome|Posture and Movement Training|Participants will receive six training sessions with a physical therapist over a 3-week period.
11325293|NCT03373240|FG001|Participant Flow|TAU Plus Control Tasks|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.~TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games."
11325294|NCT03373240|OG000|Outcome|TAU Plus Cognitive Remediation Program|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.~TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes."
11325295|NCT03373240|OG001|Outcome|TAU Plus Control Tasks|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.~TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games."
11325296|NCT03373240|EG000|Reported Event|TAU Plus Cognitive Remediation Program|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.~TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes."
11325297|NCT03373240|EG001|Reported Event|TAU Plus Control Tasks|"Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.~TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games."
11325298|NCT03373383|BG000|Baseline|Placebo|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19.
11325299|NCT03373383|BG001|Baseline|Padsevonil 50mg BID|Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19
11325300|NCT03373383|BG002|Baseline|Padsevonil 100mg BID|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325301|NCT03373383|BG003|Baseline|Padsevonil 200mg BID|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325302|NCT03373383|BG004|Baseline|Padsevonil 400mg BID|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325303|NCT03373383|BG005|Baseline|Total Title|
11325304|NCT03373383|FG000|Participant Flow|Placebo|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19.
11325305|NCT03373383|FG001|Participant Flow|Padsevonil 50mg BID|Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19
11325306|NCT03373383|FG002|Participant Flow|Padsevonil 100mg BID|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325307|NCT03373383|FG003|Participant Flow|Padsevonil 200mg BID|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325308|NCT03373383|FG004|Participant Flow|Padsevonil 400mg BID|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19.
11325309|NCT03373383|OG000|Outcome|Placebo (FAS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).
11325310|NCT03373383|OG001|Outcome|Padsevonil 50mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.
11325311|NCT03373383|OG002|Outcome|Padsevonil 100mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.
11325312|NCT03373383|OG003|Outcome|Padsevonil 200mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.
11325313|NCT03373383|OG004|Outcome|Padsevonil 400mg BID (FAS)|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.
11325314|NCT03373383|OG000|Outcome|Placebo (SS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Safety Set (SS).
11325315|NCT03373383|OG001|Outcome|Padsevonil 50mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 50 mg and Placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325316|NCT03373383|OG002|Outcome|Padsevonil 100mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325317|NCT03373383|OG003|Outcome|Padsevonil 200mg BID (SS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325318|NCT03373383|OG004|Outcome|Padsevonil 400mg BID (SS)|Participants were randomized to receive tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325319|NCT03373383|EG000|Reported Event|Placebo Treatment Period (SS)|Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Safety Set (SS).
11325320|NCT03373383|EG001|Reported Event|Padsevonil 50mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325321|NCT03373383|EG002|Reported Event|Padsevonil 100mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325322|NCT03373383|EG003|Reported Event|Padsevonil 200mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325323|NCT03373383|EG004|Reported Event|Padsevonil 400mg BID Treatment Period (SS)|Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.
11325324|NCT03373383|EG005|Reported Event|Placebo Conversion Period (SS)|A 3-week Conversion Period was required for study participants who chose to enroll in the open-label extension (OLE) study at the end of the 12-week Maintenance Period. Participants initially randomized to placebo progressively received padsevonil in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the Safety Set (SS).
11325325|NCT03373383|EG006|Reported Event|Padsevonil 50mg BID Conversion Period (SS)|A 3-week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-week Maintenance Period. The dose for participants initially randomized to padsevonil 50mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.
11325326|NCT03373383|EG007|Reported Event|Padsevonil 100mg BID Conversion Period (SS)|A 3-week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-week Maintenance Period. The dose for participants initially randomized to padsevonil 100mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.
11325327|NCT03373383|EG008|Reported Event|Padsevonil 200mg BID Conversion Period (SS)|A 3-week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-week Maintenance Period. The dose for participants initially randomized to padsevonil 200mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.
11325328|NCT03373383|EG009|Reported Event|Padsevonil 400mg BID Conversion Period (SS)|A 3-week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-week Maintenance Period. The dose for participants initially randomized to padsevonil 400mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.
11325329|NCT03373383|EG010|Reported Event|Placebo Taper and SFU Period (SS)|"A 4-week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-week Maintenance Period. Participants initially randomized to placebo group received 5-6 placebo tablets to maintain the blinding and have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period.~Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the Safety Set (SS)."
11325330|NCT03373383|EG011|Reported Event|Padsevonil 50mg BID Taper and SFU Period (SS)|A 4-week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-week Maintenance Period. Participants initially randomized to padsevonil 50 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11325331|NCT03373383|EG012|Reported Event|Padsevonil 100mg BID Taper and SFU Period (SS)|A 4-week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-week Maintenance Period. Participants initially randomized to padsevonil 100 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11325332|NCT03373383|EG013|Reported Event|Padsevonil 200mg BID Taper and SFU Period (SS)|A 4-week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-week Maintenance Period. Participants initially randomized to padsevonil 200 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11325333|NCT03373383|EG014|Reported Event|Padsevonil 400mg BID Taper and SFU Period (SS)|A 4-week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-week Maintenance Period. Participants initially randomized to padsevonil 400 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
11325334|NCT03373591|BG000|Baseline|Liposomal Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.~Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325335|NCT03373591|BG001|Baseline|Regular Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.~Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325336|NCT03373591|BG002|Baseline|No TAP Block|Patients were randomized to receive no TAP block as a control group.
11325337|NCT03373591|BG003|Baseline|Total|Total of all reporting groups
11333589|NCT03519087|OG001|Outcome|3-week Wait Period|Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.
11325338|NCT03373591|FG000|Participant Flow|Liposomal Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.~Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325339|NCT03373591|FG001|Participant Flow|Regular Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.~Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325340|NCT03373591|FG002|Participant Flow|No TAP Block|Patients were randomized to receive no TAP block as a control group.
11325341|NCT03373591|OG000|Outcome|Liposomal Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.~Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325342|NCT03373591|OG001|Outcome|Regular Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.~Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325343|NCT03373591|OG002|Outcome|No TAP Block|Patients were randomized to receive no TAP block as a control group.
11325344|NCT03373591|EG000|Reported Event|Liposomal Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.~Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325345|NCT03373591|EG001|Reported Event|Regular Bupivacaine TAP Block|"Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline.~Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization."
11325346|NCT03373591|EG002|Reported Event|No TAP Block|Patients were randomized to receive no TAP block as a control group.
11325347|NCT03373890|BG000|Baseline|Short Burst Interval Treadmill Training High Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325348|NCT03373890|BG001|Baseline|Short Burst Interval Treadmill Training Low Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325349|NCT03373890|BG002|Baseline|Total|Total of all reporting groups
11325350|NCT03373890|FG000|Participant Flow|Short Burst Interval Treadmill Training High Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 5x/week for 4 weeks.~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325351|NCT03373890|FG001|Participant Flow|Short Burst Interval Treadmill Training Low Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 2 x/week for10 weeks.~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325352|NCT03373890|OG000|Outcome|High Frequency 5x/Week|This group received short burst interval treadmill training 5x/week for total of 20 sessions
11325353|NCT03373890|OG001|Outcome|Low Frequency 2x Week|Received short burst interval training 2x week for total of 20 sessions
11325354|NCT03373890|OG000|Outcome|Short Burst Interval Treadmill Training High Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325355|NCT03373890|OG001|Outcome|Short Burst Interval Treadmill Training Low Frequency|"All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks~Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT."
11325356|NCT03373890|EG000|Reported Event|High Frequency 5x/Week|This group received short burst interval treadmill training 5x/week for total of 20 sessions
11325357|NCT03373890|EG001|Reported Event|Low Frequency 2x Week|Received short burst interval training 2x week for total of 20 sessions
11325358|NCT03374176|BG000|Baseline|AMX-MET|500 mg amoxicillin plus 250 mg metronidazole three times a day for 7days
11325359|NCT03374176|BG001|Baseline|Clindamycin|300mg clindamycin plus placebo three times a day for 7days
11325360|NCT03374176|BG002|Baseline|Total|Total of all reporting groups
11325361|NCT03374176|FG000|Participant Flow|AMX-MET|"AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules.~1 capsule tid during 7 days.~Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325362|NCT03374176|FG001|Participant Flow|Clindamycin|"Clindamycin Clindamycin 300 mg + placebo. Capsules.~1 capsule tid during 7 days.~Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325363|NCT03374176|OG000|Outcome|AMX-MET|"AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules.~1 capsule tid during 7 days.~Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325364|NCT03374176|OG001|Outcome|Clindamycin|"Clindamycin Clindamycin 300 mg + placebo. Capsules.~1 capsule tid during 7 days.~Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325365|NCT03374176|EG000|Reported Event|AMX-MET|"AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules.~1 capsule tid during 7 days.~Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325366|NCT03374176|EG001|Reported Event|Clindamycin|"Clindamycin Clindamycin 300 mg + placebo. Capsules.~1 capsule tid during 7 days.~Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days"
11325367|NCT03374189|BG000|Baseline|EZ Close Arm|"EZ close used for port-site closure.~EZ close: EZ close used."
11325368|NCT03374189|BG001|Baseline|Carter Thomason Arm|"Carter Thomason used for port-site closure.~Carter Thomason: Carter Thomason used."
11325369|NCT03374189|BG002|Baseline|Total|Total of all reporting groups
11325370|NCT03374189|FG000|Participant Flow|EZ Close Arm|"EZ close used for port-site closure.~EZ close: EZ close used."
11325371|NCT03374189|FG001|Participant Flow|Carter Thomason Arm|"Carter Thomason used for port-site closure.~Carter Thomason: Carter Thomason used."
11325372|NCT03374189|OG000|Outcome|EZ Close Arm|"EZ close used for port-site closure.~EZ close: EZ close used."
11325373|NCT03374189|OG001|Outcome|Carter Thomason Arm|"Carter Thomason used for port-site closure.~Carter Thomason: Carter Thomason used."
11325374|NCT03374189|EG000|Reported Event|EZ Close Arm|"EZ close used for port-site closure.~EZ close: EZ close used."
11325375|NCT03374189|EG001|Reported Event|Carter Thomason Arm|"Carter Thomason used for port-site closure.~Carter Thomason: Carter Thomason used."
11325376|NCT03374358|BG000|Baseline|Control (= no Intervention Arm).|Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
11325377|NCT03374358|BG001|Baseline|Raltegravir Arm.|"Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).~Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component ."
11325378|NCT03374358|BG002|Baseline|Total|Total of all reporting groups
11325379|NCT03374358|FG000|Participant Flow|Control (= no Intervention Arm).|Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
11325380|NCT03374358|FG001|Participant Flow|Raltegravir Arm.|"Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).~Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component ."
11325381|NCT03374358|OG000|Outcome|Control (= no Intervention Arm).|Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
11325382|NCT03374358|OG001|Outcome|Raltegravir Arm.|"Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).~Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component ."
11325383|NCT03374358|EG000|Reported Event|Control (= no Intervention Arm).|Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
11325384|NCT03374358|EG001|Reported Event|Raltegravir Arm.|"Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).~Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component ."
11325385|NCT03374488|BG000|Baseline|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
11325386|NCT03374488|BG001|Baseline|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
11325387|NCT03374488|BG002|Baseline|Total|Total of all reporting groups
11325388|NCT03374488|FG000|Participant Flow|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
11325389|NCT03374488|FG001|Participant Flow|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
11325390|NCT03374488|OG000|Outcome|Pembrolizumab 200 mg + Epacadostat 100 mg BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
11325391|NCT03374488|OG001|Outcome|Pembrolizumab 200 mg + Placebo BID|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
11325392|NCT03374488|EG000|Reported Event|MK-3475 200 mg Q3W + Epacad|MK-3475 200 mg Q3W + epacad
11325393|NCT03374488|EG001|Reported Event|MK-3475 200 mg Q3W + Placeb|MK-3475 200 mg Q3W + placeb
11325394|NCT03374488|EG002|Reported Event|Total|Total
11325395|NCT03374683|BG000|Baseline|Position Statement on Active Outdoor Play|"Position Statement Active Outdoor Play: The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that access to active play in nature and outdoors - with its risks - is essential for healthy child development and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION Canada, 2015; Tremblay et al., 2015)."
11325396|NCT03374683|BG001|Baseline|Risk Reframing (RR) Digital Tool|"RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.~Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.~Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date."
11325397|NCT03374683|BG002|Baseline|RR In-Person Workshop|RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
11325398|NCT03374683|BG003|Baseline|Total|Total of all reporting groups
11325399|NCT03374683|FG000|Participant Flow|Position Statement Active Outdoor Play|"Position Statement Active Outdoor Play: The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that access to active play in nature and outdoors - with its risks - is essential for healthy child development and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION Canada, 2015; Tremblay et al., 2015)."
11325400|NCT03374683|FG001|Participant Flow|Risk Reframing (RR) Digital Tool|"RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.~Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.~Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date."
11325401|NCT03374683|FG002|Participant Flow|RR In-Person Workshop|RR In-Person Workshop: Participants engage in a 2-hour facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
11325402|NCT03374683|OG000|Outcome|Position Statement on Active Outdoor Play|"Position Statement Active Outdoor Play: The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that access to active play in nature and outdoors - with its risks - is essential for healthy child development and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION, 2015; Tremblay et al., 2015)."
11325403|NCT03374683|OG001|Outcome|Risk Reframing (RR) Digital Tool|"RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.~Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.~Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date."
11325404|NCT03374683|OG002|Outcome|RR In-Person Workshop|RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
11325405|NCT03374683|EG000|Reported Event|Risk Reframing (RR) Digital Tool|"RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.~Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.~Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date."
11325406|NCT03374683|EG001|Reported Event|RR In-Person Workshop|RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
11325407|NCT03374683|EG002|Reported Event|Position Statement on Active Outdoor Play|"Position Statement Active Outdoor Play: The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that access to active play in nature and outdoors - with its risks - is essential for healthy child development and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION, 2015; Tremblay et al., 2015)."
11325408|NCT03374995|BG000|Baseline|Group I (Topical Keratin)|"Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).~Quality-of-Life Assessment: Ancillary studies~Topical Keratin: Given topically"
11325409|NCT03374995|BG001|Baseline|Group II (Standard of Care)|"Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).~Best Practice: Receive standard of care~Quality-of-Life Assessment: Ancillary studies"
11325410|NCT03374995|BG002|Baseline|Total|Total of all reporting groups
11325411|NCT03374995|FG000|Participant Flow|Group I (Topical Keratin)|"Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).~Quality-of-Life Assessment: Ancillary studies~Topical Keratin: Given topically"
11325412|NCT03374995|FG001|Participant Flow|Group II (Standard of Care)|"Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).~Best Practice: Receive standard of care~Quality-of-Life Assessment: Ancillary studies"
11325413|NCT03374995|OG000|Outcome|Group I (Topical Keratin)|"Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).~Quality-of-Life Assessment: Ancillary studies~Topical Keratin: Given topically"
11325414|NCT03374995|OG001|Outcome|Group II (Standard of Care)|"Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).~Best Practice: Receive standard of care~Quality-of-Life Assessment: Ancillary studies"
11325415|NCT03374995|EG000|Reported Event|Group I (Topical Keratin)|"Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).~Quality-of-Life Assessment: Ancillary studies~Topical Keratin: Given topically"
11325416|NCT03374995|EG001|Reported Event|Group II (Standard of Care)|"Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).~Best Practice: Receive standard of care~Quality-of-Life Assessment: Ancillary studies"
11325417|NCT03375294|BG000|Baseline|Nitrous Oxide|"PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour~Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation"
11325418|NCT03375294|FG000|Participant Flow|Nitrous Oxide|"PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour~Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation"
11325419|NCT03375294|OG000|Outcome|Nitrous Oxide|"PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour~Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation"
11325420|NCT03375294|EG000|Reported Event|Nitrous Oxide|"PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour~Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation"
11325421|NCT03376061|BG000|Baseline|Topical TxA (Intervention)|50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.
11325422|NCT03376061|BG001|Baseline|Intravenous TxA (Control)|Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
11325423|NCT03376061|BG002|Baseline|Total|Total of all reporting groups
11325424|NCT03376061|FG000|Participant Flow|Topical TxA (Intervention)|50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
11325425|NCT03376061|FG001|Participant Flow|Intravenous TxA (Control)|Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
11325426|NCT03376061|OG000|Outcome|Topical TxA (Intervention)|50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
11325427|NCT03376061|OG001|Outcome|Intravenous TxA (Control)|Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
11325428|NCT03376061|OG000|Outcome|Topical TxA (Intervention)|50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.
11325429|NCT03376061|EG000|Reported Event|Topical TxA (Intervention)|50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
11325430|NCT03376061|EG001|Reported Event|Intravenous TxA (Control)|Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
11325431|NCT03376256|BG000|Baseline|Phase A - Thoracic ES With LOR|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325432|NCT03376256|BG001|Baseline|Phase B - Thoracic ES With Compuflo|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325433|NCT03376256|BG002|Baseline|Total|Total of all reporting groups
11325434|NCT03376256|FG000|Participant Flow|Phase A - Thoracic ES With LOR|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325435|NCT03376256|FG001|Participant Flow|Phase B - Thoracic ES With Compuflo|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325436|NCT03376256|OG000|Outcome|Phase A - Thoracic ES With LOR|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325437|NCT03376256|OG001|Outcome|Phase B - Thoracic ES With Compuflo|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325438|NCT03376256|EG000|Reported Event|Phase A - Thoracic ES With LOR|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325439|NCT03376256|EG001|Reported Event|Phase B - Thoracic ES With Compuflo|"Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.~Compuflo Epidural Instrument: Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia."
11325440|NCT03376295|BG000|Baseline|LABA-ICS|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.
11325441|NCT03376295|BG001|Baseline|LABA-TIO|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
11325442|NCT03376295|BG002|Baseline|Total|Total of all reporting groups
11325443|NCT03376295|FG000|Participant Flow|LABA-ICS|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.
11325444|NCT03376295|FG001|Participant Flow|LABA-TIO|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
11325445|NCT03376295|OG000|Outcome|LABA-ICS|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.
11325446|NCT03376295|OG001|Outcome|LABA-TIO|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
11325447|NCT03376295|EG000|Reported Event|LABA-ICS|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.
11325448|NCT03376295|EG001|Reported Event|LABA-TIO|The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
11325449|NCT03376321|BG000|Baseline|Pimodivir + SOC|Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325450|NCT03376321|BG001|Baseline|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325451|NCT03376321|BG002|Baseline|Total|Total of all reporting groups
11325452|NCT03376321|FG000|Participant Flow|Pimodivir + SOC|Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325453|NCT03376321|FG001|Participant Flow|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325454|NCT03376321|OG000|Outcome|Pimodivir + SOC|Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325455|NCT03376321|OG001|Outcome|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325456|NCT03376321|EG000|Reported Event|Pimodivir + SOC|Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid
11325457|NCT03376321|EG001|Reported Event|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
11325458|NCT03376516|BG000|Baseline|Wilate|The safety (SAF) population includes all patients who received at least one injection of Wilate during the study (n=10).
11325459|NCT03376516|FG000|Participant Flow|Wilate|"A total of 11 patients were enrolled in this study. For the pharmacokinetic (PK) assessment a single dose of Wilate (50±5 IU/kg BW) was administered to 10 patients.~Prophylactic treatment: Wilate (20-40 IU/kg BW) was administered every 2-3 days for 6 months. In case of unacceptably frequent spontaneous breakthrough bleeding episodes (BEs) the dose of Wilate was to be increased by approximately 5 IU/kg.~The dose (and duration) of treatment for breakthrough BEs was dependent on the location and extent of bleeding and on the clinical condition of the patient; range: 10-50 IU/kg every 12-24 hours or 8-24 hours until resolved.~Two patients underwent surgery treated with Wilate (SURG population). Minor surgeries received 15-30 IU/kg of Wilate every 24 hours until healing was achieved. Major surgeries were treated with 40-50 IU/kg, repeat injection every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a FVIII activity of 30% to 60%."
11325460|NCT03376516|OG000|Outcome|Wilate|PK population
11325461|NCT03376516|OG000|Outcome|1-<6 Years|FAS population patients aged 1-<6 years
11325462|NCT03376516|OG001|Outcome|6-<12 Years|FAS population patients aged 6-<12 years
11325463|NCT03376516|OG002|Outcome|Total|All patients in the FAS population.
11325464|NCT03376516|OG000|Outcome|Wilate|FAS population
11325465|NCT03376516|OG000|Outcome|1-<6 Years|All patients in the PP population aged 1-<6 years.
11325466|NCT03376516|OG001|Outcome|6-<12 Years|All patients in the PP population aged 6-<12 years.
11325467|NCT03376516|OG002|Outcome|Total|All patients in the PP population
11325468|NCT03376516|OG000|Outcome|1-<6 Years|All patients in the FAS population aged 1-<6 years.
11325469|NCT03376516|OG001|Outcome|6-<12 Years|All patients in the FAS population aged 6-<12 years.
11325470|NCT03376516|OG002|Outcome|Total|Total patients in the FAS population
11325471|NCT03376516|OG000|Outcome|Wilate|The safety (SAF) population
11325472|NCT03376516|EG000|Reported Event|Wilate|The safety (SAF) population includes all patients who received at least one injection of Wilate during the study (n=10).
11325473|NCT03377127|BG000|Baseline|Standard Of Care|"The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11333590|NCT03519087|OG002|Outcome|Observational Arm|Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
11325474|NCT03377127|BG001|Baseline|SOC and PMDC|"The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.~Pharmacy Managed Diabetes Clinic (PMDC): The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325475|NCT03377127|BG002|Baseline|Total|Total of all reporting groups
11325476|NCT03377127|FG000|Participant Flow|Standard Of Care|"The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325477|NCT03377127|FG001|Participant Flow|SOC and PMDC|"The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.~Pharmacy Managed Diabetes Clinic (PMDC): The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325478|NCT03377127|OG000|Outcome|Standard Of Care|"The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325479|NCT03377127|OG001|Outcome|SOC and PMDC|"The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.~Pharmacy Managed Diabetes Clinic (PMDC): The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325480|NCT03377127|EG000|Reported Event|Standard Of Care|"The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325481|NCT03377127|EG001|Reported Event|SOC and PMDC|"The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.~Pharmacy Managed Diabetes Clinic (PMDC): The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.~Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations"
11325482|NCT03377244|BG000|Baseline|HBHS|"Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors."
11325483|NCT03377244|BG001|Baseline|HBHS Policy|"Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors."
11325484|NCT03377244|BG002|Baseline|WORD DPP|"Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11325485|NCT03377244|BG003|Baseline|Total|Total of all reporting groups
11325486|NCT03377244|FG000|Participant Flow|HBHS|"Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors."
11325487|NCT03377244|FG001|Participant Flow|HBHS Policy|"Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors."
11325488|NCT03377244|FG002|Participant Flow|WORD DPP|"Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11325489|NCT03377244|OG000|Outcome|HBHS|"Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors."
11325490|NCT03377244|OG001|Outcome|HBHS Policy|"Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors."
11325491|NCT03377244|OG002|Outcome|WORD DPP|"Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11325492|NCT03377244|EG000|Reported Event|HBHS|"Participants in the HBHS arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS: Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors."
11325493|NCT03377244|EG001|Reported Event|HBHS Policy|"Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.~HBHS Policy: Church-level policy changes that encourages participants to engage in healthy behaviors."
11325494|NCT03377244|EG002|Reported Event|WORD DPP|"Participants in the WORD DPP arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.~WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health."
11325495|NCT03377556|BG000|Baseline|Talazoparib|"Participants receive talazoparib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO"
11325496|NCT03377556|FG000|Participant Flow|Talazoparib|"Participants receive talazoparib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO"
11325497|NCT03377556|OG000|Outcome|Talazoparib|"Participants receive talazoparib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO"
11325498|NCT03377556|EG000|Reported Event|Talazoparib|"Participants receive talazoparib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Talazoparib: Given PO"
11325499|NCT03377634|BG000|Baseline|Intervention|"Participants receive the MORPH intervention.~MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss."
11325500|NCT03377634|BG001|Baseline|Control|The wait list control participants receive usual care and are offered intervention materials on completion of the study.
11325501|NCT03377634|BG002|Baseline|Total|Total of all reporting groups
11325502|NCT03377634|FG000|Participant Flow|Intervention|"Participants receive the MORPH intervention.~MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss."
11325503|NCT03377634|FG001|Participant Flow|Control|The wait list control participants receive usual care and are offered intervention materials on completion of the study.
11325504|NCT03377634|OG000|Outcome|Intervention|"Participants receive the MORPH intervention.~MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss."
11325505|NCT03377634|OG001|Outcome|Control|The wait list control participants receive usual care and are offered intervention materials on completion of the study.
11325506|NCT03377634|EG000|Reported Event|Intervention|"Participants receive the MORPH intervention.~MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss."
11325507|NCT03377634|EG001|Reported Event|Control|The wait list control participants receive usual care and are offered intervention materials on completion of the study.
11325508|NCT03378076|BG000|Baseline|FX006 64 mg|Single 5 mL IA injection into each knee
11325509|NCT03378076|BG001|Baseline|TAcs IR 80mg|Single 5 mL IA injection into each knee
11325510|NCT03378076|BG002|Baseline|Total|Total of all reporting groups
11325511|NCT03378076|FG000|Participant Flow|FX006 32 mg|12 subjects received FX006 32 mg as a single 5 mL IA injection into each knee for a total of total 64 mg dose
11325512|NCT03378076|FG001|Participant Flow|TAcs IR 40 mg|12 subjects received TAcs 40 mg as a single 5 mL IA injection into each knee for a total 80 mg dose
11325513|NCT03378076|OG000|Outcome|FX006 32 mg|Two 5 mL IA injections (total dose of 64 mg)
11325514|NCT03378076|OG001|Outcome|TAcs 40 mg|Two 1mL IA injections (total dose of 80 mg)
11325515|NCT03378076|EG000|Reported Event|FX006 32 mg|"Two 5 mL intra-articular injection~FX006: Sustained Release Steroid"
11325516|NCT03378076|EG001|Reported Event|TAcs 40 mg|"Commercially available triamcinolone acetonide, two 1 mL intra-articular injection~TAcs: Immediate Release Steroid"
11325517|NCT03378635|BG000|Baseline|Dasiglucagon 0.6 mg|"Single fixed dose (s.c.injection) of dasiglucagon~Dasiglucagon: Glucagon analog"
11325518|NCT03378635|BG001|Baseline|Placebo|"Single fixed dose (s.c.injection) of placebo~Placebo: Placebo for dasiglucagon"
11325519|NCT03378635|BG002|Baseline|GlucaGen® 1.0 mg|"Single fixed dose (s.c.injection) of GlucaGen®~GlucaGen: Native glucagon"
11325520|NCT03378635|BG003|Baseline|Total|Total of all reporting groups
11325521|NCT03378635|FG000|Participant Flow|Dasiglucagon 0.6 mg|"Single fixed dose (s.c.injection) of dasiglucagon~Dasiglucagon: Glucagon analog"
11325522|NCT03378635|FG001|Participant Flow|Placebo|"Single fixed dose (s.c.injection) of placebo~Placebo: Placebo for dasiglucagon"
11325523|NCT03378635|FG002|Participant Flow|GlucaGen® 1.0 mg|"Single fixed dose (s.c.injection) of GlucaGen®~GlucaGen: Native glucagon"
11325524|NCT03378635|OG000|Outcome|Dasiglucagon 0.6 mg|"Single fixed dose (s.c.injection) of dasiglucagon~Dasiglucagon: Glucagon analog"
11325525|NCT03378635|OG001|Outcome|Placebo|"Single fixed dose (s.c.injection) of placebo~Placebo: Placebo for dasiglucagon"
11325526|NCT03378635|OG002|Outcome|GlucaGen® 1.0 mg|"Single fixed dose (s.c.injection) of GlucaGen®~GlucaGen: Native glucagon"
11325527|NCT03378635|OG001|Outcome|GlucaGen® 1.0 mg|"Single fixed dose (s.c.injection) of GlucaGen®~GlucaGen: Native glucagon"
11325528|NCT03378635|EG000|Reported Event|Dasiglucagon 0.6 mg|"Single fixed dose (s.c.injection) of dasiglucagon~Dasiglucagon: Glucagon analog"
11325529|NCT03378635|EG001|Reported Event|Placebo|"Single fixed dose (s.c.injection) of placebo~Placebo: Placebo for dasiglucagon"
11325530|NCT03378635|EG002|Reported Event|GlucaGen® 1.0 mg|"Single fixed dose (s.c.injection) of GlucaGen®~GlucaGen: Native glucagon"
11325531|NCT03378921|BG000|Baseline|Donors Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325532|NCT03378921|BG001|Baseline|Patients Own Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325533|NCT03378921|BG002|Baseline|Total|Total of all reporting groups
11325534|NCT03378921|FG000|Participant Flow|Donors Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325535|NCT03378921|FG001|Participant Flow|Patients Own Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325536|NCT03378921|OG000|Outcome|Donors Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325537|NCT03378921|OG001|Outcome|Patients Own Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325538|NCT03378921|EG000|Reported Event|Donors Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325539|NCT03378921|EG001|Reported Event|Patients Own Feces|"Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT.~Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52."
11325540|NCT03378973|BG000|Baseline|High Dose Dexmedetomidine|"Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325541|NCT03378973|BG001|Baseline|Low Dose Dexmedetomidine|"Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325542|NCT03378973|BG002|Baseline|Total|Total of all reporting groups
11325543|NCT03378973|FG000|Participant Flow|Low Dose Dexmedetomidine|"Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325544|NCT03378973|FG001|Participant Flow|Highdose Dexmedetomidine|"Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325545|NCT03378973|OG000|Outcome|Low Dose Dexmedetomidine|"Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325546|NCT03378973|OG001|Outcome|High Dose Dexmedetomidine|"Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325547|NCT03378973|EG000|Reported Event|Low Dose Dexmedetomidine|"Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325548|NCT03378973|EG001|Reported Event|High Dose Dexmedetomidine|"Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min~Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery."
11325549|NCT03379259|BG000|Baseline|Phase 1A: BGB-A333 450 mg|BGB-A333 450 mg, intravenously, every 3 weeks
11325550|NCT03379259|BG001|Baseline|Phase 1A: BGB-A333 900mg|BGB-A333 900mg, intravenously, every 3 weeks
11325551|NCT03379259|BG002|Baseline|Phase 1A: BGB-A333 1350 mg|BGB-A333 1350 mg, intravenously, every 3 weeks
11325552|NCT03379259|BG003|Baseline|Phase 1A: BGB-A333 1800 mg|BGB-A333 1800 mg, intravenously, every 3 weeks
11325553|NCT03379259|BG004|Baseline|Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325554|NCT03379259|BG005|Baseline|Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325555|NCT03379259|BG006|Baseline|Total|Total of all reporting groups
11325556|NCT03379259|FG000|Participant Flow|Phase 1A: BGB-A333 450 mg|BGB-A333 450 mg, intravenously, every 3 weeks
11325557|NCT03379259|FG001|Participant Flow|Phase 1A: BGB-A333 900mg|BGB-A333 900mg, intravenously, every 3 weeks
11325558|NCT03379259|FG002|Participant Flow|Phase 1A: BGB-A333 1350 mg|BGB-A333 1350 mg, intravenously, every 3 weeks
11325559|NCT03379259|FG003|Participant Flow|Phase 1A: BGB-A333 1800 mg|BGB-A333 1800 mg, intravenously, every 3 weeks
11325560|NCT03379259|FG004|Participant Flow|Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325561|NCT03379259|FG005|Participant Flow|Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325562|NCT03379259|OG000|Outcome|Phase 1A: BGB-A333 450 mg|BGB-A333 450 mg, intravenously, every 3 weeks
11325563|NCT03379259|OG001|Outcome|Phase 1A: BGB-A333 900 mg|BGB-A333 900mg, intravenously, every 3 weeks
11325564|NCT03379259|OG002|Outcome|Phase 1A: BGB-A333 1350 mg|BGB-A333 1350 mg, intravenously, every 3 weeks
11325565|NCT03379259|OG003|Outcome|Phase 1A: BGB-A333 1800 mg|BGB-A333 1800 mg, intravenously, every 3 weeks
11325566|NCT03379259|OG004|Outcome|Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325567|NCT03379259|OG005|Outcome|Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325568|NCT03379259|OG000|Outcome|Phase 1A: BGB-A333 Monotherapy Dose Escalation|BGB-A333 450 mg to 1800 mg every three weeks until they were no longer considered to be achieving clinical benefit, showed unacceptable toxicity, or met other discontinuation criteria as determined by the Investigator
11325569|NCT03379259|OG000|Outcome|Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325570|NCT03379259|OG001|Outcome|Phase 1A: BGB-A333 900 mg|BGB-A333 900 mg, intravenously, every 3 weeks
11325571|NCT03379259|EG000|Reported Event|Phase 1A: BGB-A333 450 mg|BGB-333 450 mg, intravenously, every 3 weeks
11325572|NCT03379259|EG001|Reported Event|Phase 1A: BGB-A333 900 mg|BGB-333 900 mg, intravenously, every 3 weeks
11325573|NCT03379259|EG002|Reported Event|Phase 1A: BGB-333 1350 mg|BGB-333 1350 mg, intravenously, every 3 weeks
11325574|NCT03379259|EG003|Reported Event|Phase 1A: BGB-333 1800 mg|BGB-333 1800 mg, intravenously, every 3 weeks
11325575|NCT03379259|EG004|Reported Event|Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325576|NCT03379259|EG005|Reported Event|Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg|BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
11325577|NCT03379376|BG000|Baseline|Supportive Care (eMMB)|"Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.~Questionnaire Administration: Receive questionnaire~Supportive Care: Undergo eHealth mindful moving and breathing"
11325578|NCT03379376|FG000|Participant Flow|Supportive Care (eMMB)|"Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.~Questionnaire Administration: Receive questionnaire~Supportive Care: Undergo eHealth mindful moving and breathing"
11325579|NCT03379376|OG000|Outcome|Supportive Care (eMMB)|"Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.~Questionnaire Administration: Receive questionnaire~Supportive Care: Undergo eHealth mindful moving and breathing"
11325580|NCT03379376|EG000|Reported Event|Supportive Care (eMMB)|"Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.~Questionnaire Administration: Receive questionnaire~Supportive Care: Undergo eHealth mindful moving and breathing"
11325581|NCT03379506|BG000|Baseline|Age Cohort 1: 12 to <18 Years: Mini and Expanded|Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
11325582|NCT03379506|BG001|Baseline|Age Cohort 2: 7 to <12 Years: Mini and Expanded|Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
11325583|NCT03379506|BG002|Baseline|Age Cohort 3: 3 to <7 Years: Mini|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
11325584|NCT03379506|BG003|Baseline|Age Cohort 3: 3 to <7 Years: Expanded|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
11325585|NCT03379506|BG004|Baseline|Total|Total of all reporting groups
11325586|NCT03379506|FG000|Participant Flow|Age Cohort 1: 12 to <18 Years: Mini and Expanded|Pediatric participants 12 to <18 years of age received elbasvir (EBR) 50 mg / grazoprevir (GZR) 100 mg fixed dose combination (FDC) tablets once daily for 12 weeks.
11325587|NCT03379506|FG001|Participant Flow|Age Cohort 2: 7 to <12 Years: Mini and Expanded|Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
11325588|NCT03379506|FG002|Participant Flow|Age Cohort 3: 3 to <7 Years: Mini|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
11325589|NCT03379506|FG003|Participant Flow|Age Cohort 3: 3 to <7 Years: Expanded|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
11325590|NCT03379506|OG000|Outcome|Age Cohort 1: 12 to <18 Years: Mini and Expanded|Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
11325591|NCT03379506|OG001|Outcome|Age Cohort 2: 7 to <12 Years: Mini and Expanded|Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
11325592|NCT03379506|OG002|Outcome|Age Cohort 3: 3 to <7 Years: Mini|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
11325593|NCT03379506|OG003|Outcome|Age Cohort 3: 3 to <7 Years: Expanded|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
11325594|NCT03379506|EG000|Reported Event|Age Cohort 1: 12 to < 18 Years|Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
11325595|NCT03379506|EG001|Reported Event|Age Cohort 2: 7 to < 12 Years|Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
11325596|NCT03379506|EG002|Reported Event|Age Cohort 3 Mini: 3 to < 7 Years|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
11325597|NCT03379506|EG003|Reported Event|Age Cohort 3 Expanded: 3 to < 7 Years|Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
11325598|NCT03379545|BG000|Baseline|Shoulder Arthroplasty (SA)|"3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)~3-dimensional (3D) magnetic resonance (MR): MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.~3D computed tomography (CT) imaging: The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid."
11325599|NCT03379545|FG000|Participant Flow|Shoulder Arthroplasty (SA)|"3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)~3-dimensional (3D) magnetic resonance (MR): MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.~3D computed tomography (CT) imaging: The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid."
11325600|NCT03379545|OG000|Outcome|Shoulder Arthroplasty (SA)|"3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)~3-dimensional (3D) magnetic resonance (MR): MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.~3D computed tomography (CT) imaging: The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid."
11336024|NCT03559933|FG000|Participant Flow|Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy|Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
11325601|NCT03379545|OG000|Outcome|3D MR and 3D CT Imaging|"All shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging.~3-dimensional (3D) magnetic resonance (MR) imaging: MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.~3D computed tomography (CT) imaging: The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid."
11325602|NCT03379545|EG000|Reported Event|Shoulder Arthroplasty (SA)|"3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)~3-dimensional (3D) magnetic resonance (MR): MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.~3D computed tomography (CT) imaging: The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid."
11325603|NCT03379662|BG000|Baseline|Erchonia HLS Laser|"The Erchonia HLS Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Erchonia HLS Laser: The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes."
11325604|NCT03379662|BG001|Baseline|Placebo Laser|"The Placebo Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect."
11325605|NCT03379662|BG002|Baseline|Total|Total of all reporting groups
11325606|NCT03379662|FG000|Participant Flow|Erchonia HLS Laser|"The Erchonia HLS Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Erchonia HLS Laser: The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes."
11325607|NCT03379662|FG001|Participant Flow|Placebo Laser|"The Placebo Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect."
11325608|NCT03379662|OG000|Outcome|Erchonia HLS Laser|"The Erchonia HLS Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Erchonia HLS Laser: The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes."
11325609|NCT03379662|OG001|Outcome|Placebo Laser|"The Placebo Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect."
11325610|NCT03379662|EG000|Reported Event|Erchonia HLS Laser|"The Erchonia HLS Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Erchonia HLS Laser: The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes."
11325611|NCT03379662|EG001|Reported Event|Placebo Laser|"The Placebo Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.~Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect."
11325612|NCT03379740|BG000|Baseline|Product Exposure Sequence 1|"Subjects will be randomized to follow a sequence of product exposure comprised of :~E-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA~E-cigarette: Subject's own e-cigarette~P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid~P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid~P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid~P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid"
11325613|NCT03379740|BG001|Baseline|Product Exposure Sequence 2|"Subjects will be randomized to follow a sequence of product exposure comprised of :~E-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA~E-cigarette: Subject's own e-cigarette~P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid~P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid~P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid~P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid"
11325614|NCT03379740|BG002|Baseline|Total|Total of all reporting groups
11325615|NCT03379740|FG000|Participant Flow|Product Exposure Sequence 1|"Subjects will be randomized to follow a sequence of product exposure comprised of :~E-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA~E-cigarette: Subject's own e-cigarette~P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid~P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid~P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid~P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid"
11325616|NCT03379740|FG001|Participant Flow|Product Exposure Sequence 2|"Subjects will be randomized to follow a sequence of product exposure comprised of :~E-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA~E-cigarette: Subject's own e-cigarette~P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid~P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid~P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid~P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid"
11325617|NCT03379740|OG000|Outcome|Subject's Own E-cigarette|Subject's own e-cigarette with e-liquid
11325618|NCT03379740|OG001|Outcome|P4M3-1.7%|P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
11325619|NCT03379740|OG002|Outcome|P4M3-1.7%LA|P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
11325620|NCT03379740|OG003|Outcome|P4M3-3%LA|P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
11325621|NCT03379740|OG004|Outcome|P4M3-4%LA|P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
11325622|NCT03379740|EG000|Reported Event|P4M3-1.7% Product Test|On Admission Day (day -2) all subjects were invited to test the P4M3 product for 10 minutes.
11325623|NCT03379740|EG001|Reported Event|Subject's Own E-cigarette|Subject's own e-cigarette with e-liquid
11325624|NCT03379740|EG002|Reported Event|P4M3-1.7%|P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
11325625|NCT03379740|EG003|Reported Event|P4M3-1.7%LA|P4M3 with e-liquid concentrations of 1.7% nicotine with 1.1% lactic acid
11325626|NCT03379740|EG004|Reported Event|P4M3-3%LA|P4M3 with e-liquid concentrations of 3% nicotine with 1.1% lactic acid
11325627|NCT03379740|EG005|Reported Event|P4M3-4%LA|P4M3 with e-liquid concentrations of 4% nicotine with 2% lactic acid
11325628|NCT03379753|BG000|Baseline|Intervention Group|"Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.~music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room."
11325629|NCT03379753|BG001|Baseline|Control Group|Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
11325630|NCT03379753|BG002|Baseline|Total|Total of all reporting groups
11325631|NCT03379753|FG000|Participant Flow|Intervention Group|"Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.~music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room."
11325632|NCT03379753|FG001|Participant Flow|Control Group|Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
11325633|NCT03379753|OG000|Outcome|Intervention Group|"Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.~music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room."
11325634|NCT03379753|OG001|Outcome|Control Group|Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
11325635|NCT03379753|EG000|Reported Event|Intervention Group|"Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.~music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room."
11325636|NCT03379753|EG001|Reported Event|Control Group|Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
11325637|NCT03380000|BG000|Baseline|Randomized, Nitrate-rich or -Depleted Beetroot Juice on Two Separate Days|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.~Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).~Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK)."
11325638|NCT03380000|FG000|Participant Flow|Nitrate Depleted Beetroot Juice First, Then Nitrate Rich Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.~Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).~Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK)."
11325639|NCT03380000|FG001|Participant Flow|Nitrate Rich Beetroot Juice First, Then Nitrate Depleted Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.~Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).~Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK)."
11325640|NCT03380000|OG000|Outcome|Randomized, Nitrate Rich Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.~Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK)."
11325641|NCT03380000|OG001|Outcome|Randomized, Nitrate Depleted Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.~Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK)."
11325642|NCT03380000|EG000|Reported Event|Randomized, Nitrate Rich Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.~Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK)."
11325643|NCT03380000|EG001|Reported Event|Randomized, Nitrate Depleted Beetroot Juice|"Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.~Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK)."
11336025|NCT03559933|OG000|Outcome|Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy|Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
11325644|NCT03380026|BG000|Baseline|All Participants|"Group consisting of all trial participants that completed screening and randomization.~In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone.~For the Valchlor only group, Valchlor is applied once nightly to the target lesions.~For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2~For both groups, the treatment period spanned four months."
11325645|NCT03380026|FG000|Participant Flow|All Participants|"Group consisting of all trial participants that completed screening and randomization.~In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone.~For the Valchlor only group, Valchlor is applied once nightly to the target lesions.~For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2~For both groups, the treatment period spanned four months."
11325646|NCT03380026|OG000|Outcome|Valchlor 0.016% Topical Gel|"0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.~Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions."
11325647|NCT03380026|OG001|Outcome|Valchlor Plus Triamcinolone|"0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.~Triamcinolone: Apply up to three times daily on select lesions.~Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions."
11325648|NCT03380026|OG000|Outcome|All Participants|Group of all analyzed study participants. Both irritant and allergic contact dermatitis was observed
11325649|NCT03380026|EG000|Reported Event|Valchlor 0.016% Topical Gel|"0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.~Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions."
11325650|NCT03380026|EG001|Reported Event|Valchlor Plus Triamcinolone|"0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.~Triamcinolone: Apply up to three times daily on select lesions.~Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions."
11325651|NCT03380091|BG000|Baseline|Vitamin D (Cholecalciferol)|"Cholecalciferol 5,000 IU PO daily~Vitamin D: Oral medication daily"
11325652|NCT03380091|BG001|Baseline|Metformin|"Metformin 1000 mg PO bid~Metformin: Oral medication daily"
11325653|NCT03380091|BG002|Baseline|Total|Total of all reporting groups
11325654|NCT03380091|FG000|Participant Flow|Vitamin D (Cholecalciferol)|"Cholecalciferol 5,000 IU PO daily~Vitamin D: Oral medication daily"
11325655|NCT03380091|FG001|Participant Flow|Metformin|"Metformin 1000 mg PO bid~Metformin: Oral medication daily"
11325656|NCT03380091|OG000|Outcome|Vitamin D (Cholecalciferol)|"Cholecalciferol 5,000 IU PO daily~Vitamin D: Oral medication daily"
11325657|NCT03380091|OG001|Outcome|Metformin|"Metformin 1000 mg PO bid~Metformin: Oral medication daily"
11325658|NCT03380091|OG000|Outcome|Metformin|"Metformin 1000 mg PO bid~Metformin: Oral medication daily"
11325659|NCT03380091|OG001|Outcome|Vitamin D (Cholecalciferol)|"Cholecalciferol 5,000 IU PO daily~Vitamin D: Oral medication daily"
11325660|NCT03380091|EG000|Reported Event|Vitamin D (Cholecalciferol)|"Cholecalciferol 5,000 IU PO daily~Vitamin D: Oral medication daily"
11325661|NCT03380091|EG001|Reported Event|Metformin|"Metformin 1000 mg PO bid~Metformin: Oral medication daily"
11325662|NCT03380390|BG000|Baseline|Oxymetazoline + Energy-Based Therapy|"Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.~Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application~Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])"
11325663|NCT03380390|FG000|Participant Flow|Oxymetazoline + Energy-Based Therapy|"Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.~Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application~Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])"
11325664|NCT03380390|OG000|Outcome|Oxymetazoline + Energy-Based Therapy|"Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.~Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application~Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])"
11325665|NCT03380390|EG000|Reported Event|Oxymetazoline + Energy-Based Therapy|"Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.~Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application~Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])"
11325666|NCT03380429|BG000|Baseline|Cohort 1: Data on Maintenance Use Supplied to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.
10827900|NCT00112294|OG000|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11325667|NCT03380429|BG001|Baseline|Cohort 2: Data on Maintenance Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
11325668|NCT03380429|BG002|Baseline|Cohort 3: Data on Maintenance and Rescue Use to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
11325669|NCT03380429|BG003|Baseline|Cohort 4: Data on Maintenance and Rescue Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
11325670|NCT03380429|BG004|Baseline|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325671|NCT03380429|BG005|Baseline|Total|Total of all reporting groups
11325672|NCT03380429|FG000|Participant Flow|Cohort 1: Data on Maintenance Use Supplied to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.
11325673|NCT03380429|FG001|Participant Flow|Cohort 2: Data on Maintenance Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
11325674|NCT03380429|FG002|Participant Flow|Cohort 3: Data on Maintenance and Rescue Use to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
11325675|NCT03380429|FG003|Participant Flow|Cohort 4: Data on Maintenance and Rescue Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
11325676|NCT03380429|FG004|Participant Flow|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325677|NCT03380429|OG000|Outcome|Cohort 1: Data on Maintenance Use Supplied to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.
11325678|NCT03380429|OG001|Outcome|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325679|NCT03380429|OG000|Outcome|Cohort 2: Data on Maintenance Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
11325680|NCT03380429|OG001|Outcome|Cohort 3: Data on Maintenance and Rescue Use to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
11325681|NCT03380429|OG002|Outcome|Cohort 4: Data on Maintenance and Rescue Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
11325682|NCT03380429|OG003|Outcome|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325683|NCT03380429|OG001|Outcome|Cohort 2: Data on Maintenance Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
11325684|NCT03380429|OG002|Outcome|Cohort 3: Data on Maintenance and Rescue Use to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
11325685|NCT03380429|OG003|Outcome|Cohort 4: Data on Maintenance and Rescue Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
11325686|NCT03380429|OG004|Outcome|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325687|NCT03380429|EG000|Reported Event|Cohort 1: Data on Maintenance Use Supplied to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard.
11325688|NCT03380429|EG001|Reported Event|Cohort 2: Data on Maintenance Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone.
11336026|NCT03559933|OG000|Outcome|PEPNS System|"The pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first.~PEPNS System: PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated."
11325689|NCT03380429|EG002|Reported Event|Cohort 3: Data on Maintenance and Rescue Use to Par and HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard.
11325690|NCT03380429|EG003|Reported Event|Cohort 4: Data on Maintenance and Rescue Use Supplied to Par|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone.
11325691|NCT03380429|EG004|Reported Event|Cohort 5: No Data Supplied to Par or HCP|Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data.
11325692|NCT03380572|BG000|Baseline|Senhance Cholecystectomy|"Cholecystectomy operation performed using Senhance robotic system~Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system"
11325693|NCT03380572|BG001|Baseline|Laparoscopic Cholecystectomy|"Cholecystectomy operation performed using standard laparoscopic instruments~Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy"
11325694|NCT03380572|BG002|Baseline|Total|Total of all reporting groups
11325695|NCT03380572|FG000|Participant Flow|Senhance Cholecystectomy|"Cholecystectomy operation performed using Senhance robotic system~Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system"
11325696|NCT03380572|FG001|Participant Flow|Laparoscopic Cholecystectomy|"Cholecystectomy operation performed using standard laparoscopic instruments~Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy"
11325697|NCT03380572|OG000|Outcome|Senhance Cholecystectomy|"Cholecystectomy operation performed using Senhance robotic system~Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system"
11325698|NCT03380572|OG001|Outcome|Laparoscopic Cholecystectomy|"Cholecystectomy operation performed using standard laparoscopic instruments~Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy"
11325699|NCT03380572|EG000|Reported Event|Senhance Cholecystectomy|"Cholecystectomy operation performed using Senhance robotic system~Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system"
11325700|NCT03380572|EG001|Reported Event|Laparoscopic Cholecystectomy|"Cholecystectomy operation performed using standard laparoscopic instruments~Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy"
11325701|NCT03380624|BG000|Baseline|Refresh Optive and Refresh Optive MEGA|"The subjects are randomly assigned to Refresh Optive or Refresh Optive MEGA (Omega 3) with measurements of lipid layer thickness following at 15 minutes and 1 hour.~After which there is a washout period before proceeding to the second eye drop at visit 2.~Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose~Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose~*All subjects completed both arms in this crossover study"
11325702|NCT03380624|FG000|Participant Flow|Refresh Optive Then Refresh Optive MEGA 3|The subjects are randomly assigned to one drop of Refresh Optive or Refresh Optive MEGA followed by measurement of lipid layer thickness at 15 minutes and 1 hour After which there is a washout period before Visit 2 - in which the measurements were repeated with the other eye drop.
11325703|NCT03380624|FG001|Participant Flow|Refresh Optive MEGA 3 Then Refresh Optive|The subjects are randomly assigned to one drop of Refresh Optive or Refresh Optive MEGA followed by measurement of lipid layer thickness at 15 minutes and 1 hour After which there is a washout period before Visit 2 - in which the measurements were repeated with the other eye drop.
11325704|NCT03380624|OG000|Outcome|Refresh Optive|"Participants were first randomized to have 1 drop of Refresh Optive instilled in each eye with measurements of lipid layer thickness following at 15 minutes and 1 hour.~After which there is a washout period before proceeding to a second visit in which Refresh Optive MEGA-3 was utilized and the measurements were repeated.~Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose~Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose~*All subjects completed both arms in this crossover study"
11325705|NCT03380624|OG001|Outcome|Refresh Optive MEGA-3|"Participants were first randomized to have 1 drop of Refresh Optive MEGA-3 instilled in each eye with measurements of lipid layer thickness following at 15 minutes and 1 hour.~After which there is a washout period before proceeding to a second visit in which Refresh Optive was utilized and the measurements were repeated."
11325706|NCT03380624|EG000|Reported Event|Refresh Optive|"The subjects are randomly assigned to Refresh Optive or Refresh Optive MEGA (Omega 3) with measurements of lipid layer thickness following at 15 minutes and 1 hour.~After which there is a washout period before proceeding to the second eye drop at visit 2.~Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose~Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose~*All subjects completed both arms in this crossover study"
11325707|NCT03380624|EG001|Reported Event|Refresh Optive MEGA|"The subjects are randomly assigned to Refresh Optive or Refresh Optive MEGA (Omega 3) with measurements of lipid layer thickness following at 15 minutes and 1 hour.~After which there is a washout period before proceeding to the second eye drop at visit 2.~Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose~Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose~*All subjects completed both arms in this crossover study"
11325708|NCT03380780|BG000|Baseline|Emicizumab|Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
11325709|NCT03380780|FG000|Participant Flow|Emicizumab|Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
11325710|NCT03380780|OG000|Outcome|Emicizumab|Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
11325711|NCT03380780|EG000|Reported Event|Emicizumab|Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
11325712|NCT03380845|BG000|Baseline|Split Face Study Bilateral Fraxel Restore vs Fractora|Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.
11325713|NCT03380845|FG000|Participant Flow|Bilateral Facial Treatment With Fraxel and Fractora|Randomized treatment with Fraxel on one side of the face, and Fractora on the opposite side of the face - the study is a randomized, split-face study in subjects seeking facial acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned.
11325714|NCT03380845|OG000|Outcome|Fraxel Restore on One Side of the Face|Fraxel Restore on one side of the face for acne scar correction
11325715|NCT03380845|OG001|Outcome|Fractora on Other Side of the Face|Fractora on other side of the face for acne scar correction
11325716|NCT03380845|EG000|Reported Event|Fraxel Restore on One Side of the Face|Fraxel Restore on one side of the face for acne scar correction
11325717|NCT03380845|EG001|Reported Event|Fractora on Other Side of the Face|Fractora on other side of the face for acne scar correction
11325718|NCT03381196|BG000|Baseline|Pimodivir + SOC|Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
11325719|NCT03381196|BG001|Baseline|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
11325720|NCT03381196|BG002|Baseline|Total|Total of all reporting groups
11325721|NCT03381196|FG000|Participant Flow|Pimodivir + SOC|Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
11325722|NCT03381196|FG001|Participant Flow|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
11325723|NCT03381196|OG000|Outcome|Pimodivir + SOC|Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
11325724|NCT03381196|OG001|Outcome|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
11325725|NCT03381196|EG000|Reported Event|Pimodivir + SOC|Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
11325726|NCT03381196|EG001|Reported Event|Placebo + SOC|Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
11325727|NCT03381248|BG000|Baseline|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11325728|NCT03381248|BG001|Baseline|Hyaluronic Acid Injection|"Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain~Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain"
11325729|NCT03381248|BG002|Baseline|Total|Total of all reporting groups
11325730|NCT03381248|FG000|Participant Flow|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11325731|NCT03381248|FG001|Participant Flow|Hyaluronic Acid Injection|"Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain~Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain"
11325732|NCT03381248|OG000|Outcome|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11325733|NCT03381248|OG001|Outcome|Hyaluronic Acid Injection|"Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain~Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain"
11325734|NCT03381248|EG000|Reported Event|Cooled Radiofrequency|"Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain~Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe"
11325735|NCT03381248|EG001|Reported Event|Hyaluronic Acid Injection|"Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain~Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain"
11325736|NCT03381339|BG000|Baseline|Powered Toothbrush Intervention|"Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.~Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene"
11325737|NCT03381339|BG001|Baseline|Manual Toothbrush|Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
11325738|NCT03381339|BG002|Baseline|Total|Total of all reporting groups
11325739|NCT03381339|FG000|Participant Flow|Powered Toothbrush Intervention|"Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.~Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene"
11325740|NCT03381339|FG001|Participant Flow|Manual Toothbrush|Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
11325741|NCT03381339|OG000|Outcome|Powered Toothbrush Intervention|"Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.~Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene"
11325742|NCT03381339|OG001|Outcome|Manual Toothbrush|Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
11325743|NCT03381339|EG000|Reported Event|Powered Toothbrush Intervention|The patients were given power toothbrush with instructions to use
11325744|NCT03381339|EG001|Reported Event|Manual Toothbrush|The patients were given power manual toothbrush with instructions to use
11325745|NCT03381742|BG000|Baseline|Clopidogrel 75mg Qdpo.|"To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.~clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least."
11325746|NCT03381742|BG001|Baseline|Ticagrelor 90mg Bidpo.|"To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least."
11325747|NCT03381742|BG002|Baseline|Ticagrelor 45mg Bidpo.|"To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.~Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least."
11325748|NCT03381742|BG003|Baseline|Ticagrelor 90mg Qdpo.|"To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least."
11325749|NCT03381742|BG004|Baseline|Total|Total of all reporting groups
11325750|NCT03381742|FG000|Participant Flow|Ticagrelor 45mg Bidpo.|"To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.~Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least."
11325751|NCT03381742|FG001|Participant Flow|Ticagrelor 90mg Bidpo.|"To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least."
11325752|NCT03381742|FG002|Participant Flow|Clopidogrel 75mg Qdpo.|"To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.~clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least."
11325753|NCT03381742|FG003|Participant Flow|Ticagrelor 90mg Qdpo.|"To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.~Ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least."
11325754|NCT03381742|OG000|Outcome|Clopidogrel 75mg Qdpo.|"To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.~clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least."
11325755|NCT03381742|OG001|Outcome|Ticagrelor 90mg Bidpo.|"To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least."
11325756|NCT03381742|OG002|Outcome|Ticagrelor 45mg Bidpo.|"To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.~Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least."
11325757|NCT03381742|OG003|Outcome|Ticagrelor 90mg Qdpo.|"To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least."
11325758|NCT03381742|EG000|Reported Event|Clopidogrel 75mg Qdpo.|"To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.~clopidogrel: clopidogrel 75 mg once daily for 5 consecutive days at least."
11325759|NCT03381742|EG001|Reported Event|Ticagrelor 90mg Bidpo.|"To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg twice daily for 5 consecutive days at least."
11325760|NCT03381742|EG002|Reported Event|Ticagrelor 45mg Bidpo.|"To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.~Ticagrelor: ticagrelor 45 mg twice daily for 5 consecutive days at least."
11325761|NCT03381742|EG003|Reported Event|Ticagrelor 90mg Qdpo.|"To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.~ticagrelor: ticagrelor 90 mg once daily for 5 consecutive days at least."
11325762|NCT03381989|BG000|Baseline|Single Arm: Open-label Treatment|The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
11325763|NCT03381989|FG000|Participant Flow|Single Arm: Open-label Treatment|The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
11325764|NCT03381989|OG000|Outcome|Single Arm: Open-label Treatment|The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
11325765|NCT03381989|OG000|Outcome|Single Arm: Open-label Treatment|The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.Laceration of the aortic valve leaflet using electrosurgery energy.
11325766|NCT03381989|EG000|Reported Event|Single Arm: Open-label Treatment|The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
11325767|NCT03382262|BG000|Baseline|FX006 32 mg Shoulder|"Single intra-articular (IA) injection of FX006 32 mg in the Shoulder~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325768|NCT03382262|BG001|Baseline|TAcs 40 mg Shoulder|"Single intra-articular (IA) injection of TAcs 40 mg in the Shoulder~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325769|NCT03382262|BG002|Baseline|FX006 32 mg Hip|"Single intra-articular (IA) injection of FX006 32 mg in the Hip~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325770|NCT03382262|BG003|Baseline|TAcs 40 mg Hip|"Single intra-articular (IA) injection of TAcs 40 mg in the Hip~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325771|NCT03382262|BG004|Baseline|Total|Total of all reporting groups
11325772|NCT03382262|FG000|Participant Flow|FX006 32 mg Shoulder|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection in the Shoulder"
11325773|NCT03382262|FG001|Participant Flow|TAcs 40 mg Shoulder|"Single intra-articular (IA) injection of TAcs 40 mg~TAcs 40 mg: Immediate-release 40mg TAcs IA injection in the Shoulder"
11325774|NCT03382262|FG002|Participant Flow|FX006 32 mg Hip|"Single intra-articular (IA) injection of FX006 32 mg~FX006 32 mg: Extended-release 32 mg FX006 IA injection in the Hip"
11325775|NCT03382262|FG003|Participant Flow|TAcs 40 mg Hip|"Single intra-articular (IA) injection of TAcs 40 mg~TAcs 40 mg: Immediate-release 40mg TAcs IA injection in the Hip"
11325776|NCT03382262|OG000|Outcome|FX006 32 mg Shoulder|"Single intra-articular (IA) injection of FX006 32 mg in the Shoulder~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325777|NCT03382262|OG001|Outcome|TAcs 40 mg Shoulder|"Single intra-articular (IA) injection of TAcs 40 mg in the Shoulder~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325778|NCT03382262|OG002|Outcome|FX006 32 mg Hip|"Single intra-articular (IA) injection of FX006 32 mg in the Hip~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325779|NCT03382262|OG003|Outcome|TAcs 40 mg Hip|"Single intra-articular (IA) injection of TAcs 40 mg in the Hip~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325780|NCT03382262|EG000|Reported Event|FX006 32 mg Shoulder|"Single intra-articular (IA) injection of FX006 32 mg in the Shoulder~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325781|NCT03382262|EG001|Reported Event|TAcs 40 mg Shoulder|"Single intra-articular (IA) injection of TAcs 40 mg in the Shoulder~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325782|NCT03382262|EG002|Reported Event|FX006 32 mg Hip|"Single intra-articular (IA) injection of FX006 32 mg in the Hip~FX006 32 mg: Extended-release 32 mg FX006 IA injection"
11325783|NCT03382262|EG003|Reported Event|TAcs 40 mg Hip|"Single intra-articular (IA) injection of TAcs 40 mg in the Hip~TAcs 40 mg: Immediate-release 40mg TAcs IA injection"
11325784|NCT03382418|BG000|Baseline|Group 1: Vaccine|gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325785|NCT03382418|BG001|Baseline|Group 2: Vaccine|gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325786|NCT03382418|BG002|Baseline|Group 3: Placebo|Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
11325787|NCT03382418|BG003|Baseline|Total|Total of all reporting groups
11325788|NCT03382418|FG000|Participant Flow|Group 1: Vaccine|gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325789|NCT03382418|FG001|Participant Flow|Group 2: Vaccine|gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325790|NCT03382418|FG002|Participant Flow|Group 3: Placebo|Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
11325791|NCT03382418|OG000|Outcome|Group 1: Vaccine|gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325792|NCT03382418|OG001|Outcome|Group 2: Vaccine|gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325793|NCT03382418|OG002|Outcome|Group 3: Placebo|Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
11325794|NCT03382418|OG001|Outcome|Group 2: Vaccine|gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325795|NCT03382418|EG000|Reported Event|Group 1: Vaccine|gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325796|NCT03382418|EG001|Reported Event|Group 2: Vaccine|gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
11325797|NCT03382418|EG002|Reported Event|Group 3: Placebo|Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
11325798|NCT03382509|BG000|Baseline|BI 1467335 10 Milligram (mg) (SD)|Participants were administered single dose of 10 milligram (mg) carbon 14 (14C) labelled BI 1467335 solution orally on Day 1 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
11325799|NCT03382509|BG001|Baseline|BI 1467335 10 mg (MD)|Participants were administered once daily 10 mg (2*5 mg) BI 1467335 non-radiolabelled film-coated tablets Day 1 to Day 27 and Day 29 to a maximum of Day 40 orally with 240 milliliter (mL) of water. On Day 28 a single dose of 14C BI 1467335 oral solution was administered.
11325800|NCT03382509|BG002|Baseline|Total|Total of all reporting groups
11325801|NCT03382509|FG000|Participant Flow|BI 1467335 10 Milligram (mg) (SD)|Participants were administered single dose of 10 milligram (mg) carbon 14 (14C) labelled BI 1467335 solution orally on Day 1 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
11325802|NCT03382509|FG001|Participant Flow|BI 1467335 10 mg (MD)|Participants were administered once daily 10 mg (2*5 mg) BI 1467335 non-radiolabelled film-coated tablets Day 1 to Day 27 and Day 29 to a maximum of Day 40 orally with 240 milliliter (mL) of water. On Day 28 a single dose of 14C BI 1467335 oral solution was administered.
11325803|NCT03382509|OG000|Outcome|BI 1467335 10 Milligram (mg) (SD)|Participants were administered single dose of 10 milligram (mg) carbon 14 (14C) labelled BI 1467335 solution orally on Day 1 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
11325804|NCT03382509|OG001|Outcome|BI 1467335 10 mg (MD)|Participants were administered once daily 10 mg (2*5 mg) BI 1467335 non-radiolabelled film-coated tablets Day 1 to Day 27 and Day 29 to a maximum of Day 40 orally with 240 milliliter (mL) of water. On Day 28 a single dose of 14C BI 1467335 oral solution was administered.
11325805|NCT03382509|OG000|Outcome|BI 1467335 10 mg (MD)|Participants were administered once daily 10 mg (2*5 mg) BI 1467335 non-radiolabelled film-coated tablets Day 1 to Day 27 and Day 29 to a maximum of Day 40 orally with 240 milliliter (mL) of water. On Day 28 a single dose of 14C BI 1467335 oral solution was administered.
11325806|NCT03382509|EG000|Reported Event|BI 1467335 10 mg (MD)|Participants were administered once daily 10 mg (2*5 mg) BI 1467335 non-radiolabelled film-coated tablets Day 1 to Day 27 and Day 29 to a maximum of Day 40 orally with 240 milliliter (mL) of water. On Day 28 a single dose of 14C BI 1467335 oral solution was administered.
11325807|NCT03382509|EG001|Reported Event|BI 1467335 10 Milligram (mg) (SD)|Participants were administered single dose of 10 milligram (mg) carbon 14 (14C) labelled BI 1467335 solution orally on Day 1 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
11325808|NCT03382665|BG000|Baseline|Patients, Suffering From Severe Hip Pain and Disability|Patients in need of a total hip arthroplasty
11325809|NCT03382665|FG000|Participant Flow|Patients, Suffering From Severe Hip Pain and Disability|Patients in need of a total hip arthroplasty
11325810|NCT03382665|OG000|Outcome|Patients, Suffering From Severe Hip Pain and Disability|Preop MdA scores
11325811|NCT03382665|OG001|Outcome|Patients, Suffering From Severe Hip Pain and Disability 1|2-year MdA scores
11325812|NCT03382665|OG000|Outcome|Patients, Suffering From Severe Hip Pain and Disability|Patients in need of a total hip arthroplasty
11325813|NCT03382665|OG000|Outcome|Patients, Suffering From Severe Hip Pain and Disability 1|Preop Total WOMAC scores
11325814|NCT03382665|OG001|Outcome|Patients, Suffering From Severe Hip Pain and Disability|2-year Total WOMAC scores
11325815|NCT03382665|EG000|Reported Event|Patients, Suffering From Severe Hip Pain and Disability|Patients in need of a total hip arthroplasty
11325816|NCT03382821|BG000|Baseline|Transforaminal ESI With Dexamethasone|"Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate~Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).~Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2"
11325817|NCT03382821|BG001|Baseline|Interlaminar Catheter-targeted ESI With Triamcinolone|"Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide~Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2~Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2"
11325818|NCT03382821|BG002|Baseline|Total|Total of all reporting groups
11325819|NCT03382821|FG000|Participant Flow|Transforaminal ESI With Dexamethasone|"Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate~Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).~Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2"
11325820|NCT03382821|FG001|Participant Flow|Transforaminal Catheter-targeted ESI With Triamcinolone|"Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide~Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2~Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2"
11325821|NCT03382821|OG000|Outcome|Transforaminal ESI With Dexamethasone|"Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate~Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).~Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2"
11325822|NCT03382821|OG001|Outcome|Interlaminar Catheter-targeted ESI With Triamcinolone|"Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide~Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2~Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2"
11325823|NCT03382821|OG001|Outcome|Transforaminal Catheter-targeted ESI With Triamcinolone|"Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide~Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2~Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2"
11325824|NCT03382821|EG000|Reported Event|Transforaminal ESI With Dexamethasone|"Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate~Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).~Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2"
11325825|NCT03382821|EG001|Reported Event|Interlaminar Catheter-targeted ESI With Triamcinolone|"Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide~Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).~Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2~Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2"
11325826|NCT03382847|BG000|Baseline|Intervention Arm|"HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.~Transplant with HCV positive donor, followed by surveillance and treatment of viremia: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs"
11325827|NCT03382847|FG000|Participant Flow|Intervention Arm|"HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.~Transplant with HCV positive donor, followed by surveillance and treatment of viremia: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs"
11325828|NCT03382847|OG000|Outcome|Intervention Arm|"HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.~Transplant with HCV positive donor, followed by surveillance and treatment of viremia: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs"
11325829|NCT03382847|EG000|Reported Event|Intervention Arm|"HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.~Transplant with HCV positive donor, followed by surveillance and treatment of viremia: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs"
11325830|NCT03382899|BG000|Baseline|Pegilodecakin + Pembrolizumab|"Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) QD in the abdomen, thigh or back of upper arm.~Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle."
11325831|NCT03382899|BG001|Baseline|Pebrolizumab|Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
11325832|NCT03382899|BG002|Baseline|Total|Total of all reporting groups
11325833|NCT03382899|FG000|Participant Flow|Pegilodecakin + Pembrolizumab|"Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm.~Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle."
11325834|NCT03382899|FG001|Participant Flow|Pembrolizumab|Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
11325835|NCT03382899|OG000|Outcome|Pegilodecakin + Pembrolizumab|"Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) QD in the abdomen, thigh or back of upper arm.~Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle."
11325836|NCT03382899|OG001|Outcome|Pembrolizumab|Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
11325837|NCT03382899|EG000|Reported Event|Pegilodecakin + Pembrolizumab|"Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) QD in the abdomen, thigh or back of upper arm.~Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle."
11325838|NCT03382899|EG001|Reported Event|Pembrolizumab|Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
11325839|NCT03382912|BG000|Baseline|Pegilodecakin + Nivolumab|"Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm.~Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W."
11325840|NCT03382912|BG001|Baseline|Nivolumab|Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W, or 480 mg Q4W.
11325841|NCT03382912|BG002|Baseline|Total|Total of all reporting groups
11325842|NCT03382912|FG000|Participant Flow|Pegilodecakin+Nivolumab|"Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm.~Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W)."
11325843|NCT03382912|FG001|Participant Flow|Nivolumab|Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
11325844|NCT03382912|OG000|Outcome|Pegilodecakin + Nivolumab|"Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm.~Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W."
11325845|NCT03382912|OG001|Outcome|Nivolumab|Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
11325846|NCT03382912|EG000|Reported Event|Pegilodecakin + Nivolumab|"Participants received Pegilodecakin subcutaneously at 0.8 mg (≤80 kg body weight) or 1.6 mg (>80 kg body weight) once daily in the abdomen, thigh or back of upper arm.~Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W."
11325847|NCT03382912|EG001|Reported Event|Nivolumab|Participants received Nivolumab on day 1 of each 14 or 28 day cycle over approximately 30 minutes IV infusion at 240 mg Q2W or 480 mg Q4W.
11333591|NCT03519087|OG003|Outcome|Interdisciplinary Evaluation|"Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.~Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant."
11333592|NCT03519087|OG004|Outcome|Standard Evaluation|Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
11333593|NCT03519087|EG000|Reported Event|Interdisciplinary Evaluation|"Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.~Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant."
11333594|NCT03519087|EG001|Reported Event|Standard Evaluation|Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
11333913|NCT03521141|BG002|Baseline|Respiragene (PC-Respiragene)|"Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333914|NCT03521141|BG003|Baseline|Total|Total of all reporting groups
11333915|NCT03521141|FG000|Participant Flow|Guideline-Based Care (GBC)|"GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333916|NCT03521141|FG001|Participant Flow|Nicotine Metabolite Ratio (PC-NMR)|"Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333917|NCT03521141|FG002|Participant Flow|Respiragene (PC-Respiragene)|"Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11325848|NCT03383146|BG000|Baseline|Placebo|Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325849|NCT03383146|BG001|Baseline|Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325850|NCT03383146|BG002|Baseline|Total|Total of all reporting groups
11325851|NCT03383146|FG000|Participant Flow|Placebo|Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325852|NCT03383146|FG001|Participant Flow|Relamorelin 10 μg|Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325853|NCT03383146|OG000|Outcome|Placebo|Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325854|NCT03383146|OG001|Outcome|Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325855|NCT03383146|OG000|Outcome|Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325856|NCT03383146|EG000|Reported Event|Placebo|Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325857|NCT03383146|EG001|Reported Event|Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
11325858|NCT03383198|BG000|Baseline|Liposomal Bupivacaine Left|"Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right~Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325859|NCT03383198|BG001|Baseline|Liposomal Bupivacaine Right|"Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left~Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325860|NCT03383198|BG002|Baseline|Total|Total of all reporting groups
11325861|NCT03383198|FG000|Participant Flow|Liposomal Bupivacaine Left|"Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right~Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325862|NCT03383198|FG001|Participant Flow|Liposomal Bupivacaine Right|"Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left~Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325863|NCT03383198|OG000|Outcome|Liposomal Bupivacaine Left|"Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right~Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325864|NCT03383198|OG001|Outcome|Liposomal Bupivacaine Right|"Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left~Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325865|NCT03383198|EG000|Reported Event|Liposomal Bupivacaine|"Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right~Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325866|NCT03383198|EG001|Reported Event|Bupivacaine Plus Dexamethasone|"Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left~Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection."
11325867|NCT03383523|BG000|Baseline|Part 1a - Treatment A|"5 mg emodepside LSF, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325868|NCT03383523|BG001|Baseline|Part 1a - Treatment B|"5 mg emodepside IR-tablet #406, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325869|NCT03383523|BG002|Baseline|Part 1a - Treatment C|"5 mg emodepside IR-tablet #416, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325870|NCT03383523|BG003|Baseline|Part 1b - Treatment D|"5 mg emodepside IR-tablet #406, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325871|NCT03383523|BG004|Baseline|Part 1b - Treatment E|"5 mg emodepside IR-tablet #416, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325872|NCT03383523|BG005|Baseline|Part 2 - Treatment F|"2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325873|NCT03383523|BG006|Baseline|Part 2 - Treatment G|"2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325874|NCT03383523|BG007|Baseline|Total|Total of all reporting groups
11325875|NCT03383523|FG000|Participant Flow|Part 1a - Treatment A|"5 mg emodepside LSF, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325876|NCT03383523|FG001|Participant Flow|Part 1a - Treatment B|"5 mg emodepside IR-tablet #406, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325877|NCT03383523|FG002|Participant Flow|Part 1a - Treatment C|"5 mg emodepside IR-tablet #416, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325878|NCT03383523|FG003|Participant Flow|Part 1b - Treatment D|"5 mg emodepside IR-tablet #406, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325879|NCT03383523|FG004|Participant Flow|Part 1b - Treatment E|"5 mg emodepside IR-tablet #416, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325880|NCT03383523|FG005|Participant Flow|Part 2 - Treatment F|"2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325881|NCT03383523|FG006|Participant Flow|Part 2 - Treatment G|"2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325882|NCT03383523|OG000|Outcome|Part 1a - Treatment A|"5 mg emodepside LSF, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325883|NCT03383523|OG001|Outcome|Part 1a - Treatment B|"5 mg emodepside IR-tablet #406, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325884|NCT03383523|OG002|Outcome|Part 1a - Treatment C|"5 mg emodepside IR-tablet #416, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325885|NCT03383523|OG003|Outcome|Part 1b - Treatment D|"5 mg emodepside IR-tablet #406, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325886|NCT03383523|OG004|Outcome|Part 1b - Treatment E|"5 mg emodepside IR-tablet #416, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325887|NCT03383523|OG005|Outcome|Part 2 - Treatment F|"2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325888|NCT03383523|OG006|Outcome|Part 2 - Treatment G|"2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325889|NCT03383523|EG000|Reported Event|Part 1a - Treatment A|"5 mg emodepside LSF, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325890|NCT03383523|EG001|Reported Event|Part 1a - Treatment B|"5 mg emodepside IR-tablet #406, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325891|NCT03383523|EG002|Reported Event|Part 1a - Treatment C|"5 mg emodepside IR-tablet #416, fasted~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325892|NCT03383523|EG003|Reported Event|Part 1b - Treatment D|"5 mg emodepside IR-tablet #406, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325893|NCT03383523|EG004|Reported Event|Part 1b - Treatment E|"5 mg emodepside IR-tablet #416, fed~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325894|NCT03383523|EG005|Reported Event|Part 2 - Treatment F|"2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325895|NCT03383523|EG006|Reported Event|Part 2 - Treatment G|"2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)~Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation"
11325896|NCT03383588|BG000|Baseline|Bupivacaine 0.25%|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
11325897|NCT03383588|BG001|Baseline|Bupivacaine 0.25% + Epinephrine|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
11325898|NCT03383588|BG002|Baseline|Saline Solution|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
11325899|NCT03383588|BG003|Baseline|Total|Total of all reporting groups
11325900|NCT03383588|FG000|Participant Flow|Bupivacaine 0.25%|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
11325901|NCT03383588|FG001|Participant Flow|Bupivacaine 0.25% + Epinephrine|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
11325902|NCT03383588|FG002|Participant Flow|Saline Solution|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
11325903|NCT03383588|OG000|Outcome|Bupivacaine 0.25%|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
11325904|NCT03383588|OG001|Outcome|Bupivacaine 0.25% + Epinephrine|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
11325905|NCT03383588|OG002|Outcome|Saline Solution|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
11325906|NCT03383588|EG000|Reported Event|Bupivacaine 0.25%|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25%
11325907|NCT03383588|EG001|Reported Event|Bupivacaine 0.25% + Epinephrine|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine
11325908|NCT03383588|EG002|Reported Event|Saline Solution|standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
11325909|NCT03383614|BG000|Baseline|Cohort 1: 5mg EMODEPSIDE OD|"6 subjects with LSF emodepside 5mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325910|NCT03383614|BG001|Baseline|Cohort 2: 10mg EMODEPSIDE OD|"6 subjects with LSF emodepside 10mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325911|NCT03383614|BG002|Baseline|Cohort 3: 10mg EMODEPSIDE BID|"6 subjects with LSF emodepside 10mg, BID~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325912|NCT03383614|BG003|Baseline|Placebo Group|6 subjects with matching placebo (2 subjects per dose group)
11325913|NCT03383614|BG004|Baseline|Total|Total of all reporting groups
11325914|NCT03383614|FG000|Participant Flow|Cohort 1: 5mg EMODEPSIDE OD|"6 subjects with LSF emodepside 5mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325915|NCT03383614|FG001|Participant Flow|Cohort 2: 10mg EMODEPSIDE OD|"6 subjects with LSF emodepside 10mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325916|NCT03383614|FG002|Participant Flow|Cohort 3: 10mg EMODEPSIDE BID|"6 subjects with LSF emodepside 10mg, BID~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325917|NCT03383614|FG003|Participant Flow|Placebo Group|6 subjects with matching placebo (2 subjects per dose group)
11325918|NCT03383614|OG000|Outcome|Cohort 1: 5mg EMODEPSIDE OD|"6 subjects with LSF emodepside 5mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325919|NCT03383614|OG001|Outcome|Cohort 2: 10mg EMODEPSIDE OD|"6 subjects with LSF emodepside 10mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325920|NCT03383614|OG002|Outcome|Cohort 3: 10mg EMODEPSIDE BID|"6 subjects with LSF emodepside 10mg, BID~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325921|NCT03383614|OG003|Outcome|Placebo Group|6 subjects with matching placebo (2 subjects per dose group)
11325922|NCT03383614|OG000|Outcome|Cohort 1: Emodepside 5 mg OD|Emodepside (BAY 44-4400) 5 mg orally, once daily in fasted state.
11325923|NCT03383614|OG001|Outcome|Cohort 2: Emodepside 10 mg OD|Emodepside (BAY 44-4400) 10 mg orally, once daily in fasted state.
11325924|NCT03383614|OG002|Outcome|Cohort 3: Emodepside 10 mg BID|Emodepside (BAY 44-4400) 10 mg orally, twice a day (morning and evening) in fasted state.
11325925|NCT03383614|OG000|Outcome|Cohort 3: Emodepside 10 mg BID|Emodepside (BAY 44-4400) 10 mg orally, twice a day (morning and evening) in fasted state.
11325926|NCT03383614|OG000|Outcome|Cohort 3: 10mg EMODEPSIDE BID|"6 subjects with LSF emodepside 10mg, BID~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325927|NCT03383614|EG000|Reported Event|Cohort 1: 5mg EMODEPSIDE OD|"6 subjects with LSF emodepside 5mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325928|NCT03383614|EG001|Reported Event|Cohort 2: 10mg EMODEPSIDE OD|"6 subjects with LSF emodepside 10mg, OD~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325929|NCT03383614|EG002|Reported Event|Cohort 3: 10mg EMODEPSIDE BID|"6 subjects with LSF emodepside 10mg, BID~LSF emodepside (BAY 44-4400) oral solution (1mg/mL)"
11325930|NCT03383614|EG003|Reported Event|Placebo Group|6 subjects with matching placebo (2 subjects per dose group)
11325931|NCT03383627|BG000|Baseline|Continuous Glucose Monitoring|"If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring.~Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters.~There are no drug washout periods. Subjects will continue to take all their medications and/or insulins as prescribed by their doctor.~Baseline data including age, race, ethnicity, past medical history, home medication list, and diabetes related laboratory data will be collected."
11325932|NCT03383627|FG000|Participant Flow|Continuous Glucose Monitoring|"If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring.~Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters.~There are no drug washout periods. Subjects will continue to take all their medications and/or insulins as prescribed by their doctor.~Baseline data including age, race, ethnicity, past medical history, home medication list, and diabetes related laboratory data will be collected."
11325933|NCT03383627|OG000|Outcome|Continuous Glucose Monitoring|Subjects enrolled and wearing CGM device
11325934|NCT03383627|EG000|Reported Event|Continuous Glucose Monitoring|"If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring.~Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters.~There are no drug washout periods. Subjects will continue to take all their medications and/or insulins as prescribed by their doctor.~Baseline data including age, race, ethnicity, past medical history, home medication list, and diabetes related laboratory data will be collected."
11325935|NCT03383757|BG000|Baseline|SpO2 Sensor Application & Blood Draw|"All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured~SpO2 Sensor application & blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."
11333595|NCT03519204|BG000|Baseline|No-treatment Control|No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
11325936|NCT03383757|FG000|Participant Flow|SpO2 Sensor Application & Blood Draw|"All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured. Subject may have one or both sensors applied.~SpO2 Sensor application & blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."
11325937|NCT03383757|OG000|Outcome|SpO2 Sensor Application & Blood Draw|"All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured~SpO2 Sensor application & blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."
11325938|NCT03383757|EG000|Reported Event|SpO2 Sensor Application & Blood Draw|"All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured~SpO2 Sensor application & blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."
11325939|NCT03383783|BG000|Baseline|All Study Participants|"This was a 4-way crossover design study. All participants were randomized to receive the following interventions:~Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location."
11325940|NCT03383783|FG000|Participant Flow|All Study Participants|"This was a 4-way crossover design study. All participants were randomized to receive the following interventions:~Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location."
11325941|NCT03383783|OG000|Outcome|Bovine Specimens 0 Ppm F|This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
11325942|NCT03383783|OG001|Outcome|Bovine Specimens 250 Ppm F|This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
11325943|NCT03383783|OG002|Outcome|Bovine Specimens 500 Ppm F|This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
11325944|NCT03383783|OG003|Outcome|Bovine Specimens 1100 Ppm F|This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
11325945|NCT03383783|OG004|Outcome|Human Specimens 0 Ppm F|This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
11325946|NCT03383783|OG005|Outcome|Human Specimens 250 Ppm F|This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
11325947|NCT03383783|OG006|Outcome|Human Specimens 500 Ppm F|This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
11325948|NCT03383783|OG007|Outcome|Human Specimens 1100 Ppm F|This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
11325949|NCT03383783|EG000|Reported Event|0 Ppm F|0 parts per million fluoride
11325950|NCT03383783|EG001|Reported Event|250 Ppm F|250 parts per million fluoride
11325951|NCT03383783|EG002|Reported Event|500 Ppm F|500 parts per million fluoride
11325952|NCT03383783|EG003|Reported Event|1100 Ppm F|1100 parts per million fluoride
11325953|NCT03383783|EG004|Reported Event|Between Treatment Periods|Adverse Events that occurred between treatment periods.
11325954|NCT03383783|EG005|Reported Event|Prior to Randomization|Adverse Events that occurred prior to a subject being randomized into the study.
11325955|NCT03383887|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11325956|NCT03383887|FG000|Participant Flow|Placebo First, DAW1033D Second|Placebo-matching DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033D administered 30 mins before normal sleep time on second study night.
11325957|NCT03383887|FG001|Participant Flow|DAW1033D First, Placebo Second|DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
11325958|NCT03383887|OG000|Outcome|Placebo|"Placebo capsule 30 minutes before sleep~Placebo oral capsule: Placebo before sleep"
11325959|NCT03383887|OG001|Outcome|DAW1033D|"DAW1033D capsule 30 minutes before sleep~DAW1033D oral capsule: DAW1033D before sleep"
11325960|NCT03383887|EG000|Reported Event|Placebo|"Placebo capsule 30 minutes before sleep~Placebo oral capsule: Placebo before sleep"
11325961|NCT03383887|EG001|Reported Event|DAW1033D|"DAW1033D capsule 30 minutes before sleep~DAW1033D oral capsule: DAW1033D before sleep"
11325962|NCT03384173|BG000|Baseline|No Acute Kidney Injury (AKI)|"Infants with No AKI diagnosis.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325963|NCT03384173|BG001|Baseline|Acute Kidney Injury (AKI)|"Infants diagnosed with AKI.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325964|NCT03384173|BG002|Baseline|Total|Total of all reporting groups
11325965|NCT03384173|FG000|Participant Flow|NIRS Monitoring|"These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325966|NCT03384173|OG000|Outcome|No Acute Kidney Injury (AKI)|"Infants with No AKI diagnosis.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325967|NCT03384173|OG001|Outcome|Acute Kidney Injury (AKI)|"Infants diagnosed with AKI.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325968|NCT03384173|OG000|Outcome|Infants With Serum Creatinine Values|Any infant with serum creatinine values were included.
11325969|NCT03384173|OG000|Outcome|Neonates With Urine Output Recorded|All neonates with urine output recorded were included
11325970|NCT03384173|OG000|Outcome|Baseline Renal NIRS Values Before Caffeine|6 hour average prior to dose of caffeine
11325971|NCT03384173|OG000|Outcome|NIRS Monitoring|"These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325972|NCT03384173|EG000|Reported Event|No Acute Kidney Injury (AKI)|"Infants with No AKI diagnosis.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325973|NCT03384173|EG001|Reported Event|Acute Kidney Injury (AKI)|"Infants diagnosed with AKI.~These infants will be monitored with NIRS~Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age."
11325974|NCT03384316|BG000|Baseline|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin-1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325975|NCT03384316|BG001|Baseline|Expansion Cohort - 5 x 10^11 Viral Particles (VP)|"≤1 of 6 patients experienced a dose limiting toxicity on Dose Level 1, thus subjects were enrolled in a Dose Expansion phase.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin-1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325976|NCT03384316|BG002|Baseline|Total|Total of all reporting groups
11325977|NCT03384316|FG000|Participant Flow|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year~ETBX-061; adenoviral Mucin-1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year~ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325978|NCT03384316|FG001|Participant Flow|Expansion Cohort - 5 x 10^11 Viral Particles (VP)|"≤1 of 6 patients experienced a dose limiting toxicity on Dose Level 1, thus subjects were enrolled in a Dose Expansion phase.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325979|NCT03384316|OG000|Outcome|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325980|NCT03384316|OG001|Outcome|Expansion Cohort - 5 x 10^11 Viral Particles (VP)|"≤1 of 6 patients experienced a dose limiting toxicity on Dose Level 1, thus subjects were enrolled in a Dose Expansion phase.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325981|NCT03384316|OG000|Outcome|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year~ETBX-061; adenoviral MUC1 vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year~ETBX-011; adenoviral CEA vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11333596|NCT03519204|BG001|Baseline|JUVÉDERM® VOLBELLA® XC With Lidocaine|JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
11325982|NCT03384316|OG000|Outcome|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325983|NCT03384316|EG000|Reported Event|Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP)|"Up to 6 patients will be enrolled on Dose Level 1. If ≤1 of 6 patients experience a dose limiting toxicity, initiation of the Dose Expansion phase will occur.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325984|NCT03384316|EG001|Reported Event|Expansion Cohort - 5 x 10^11 Viral Particles (VP)|"≤1 of 6 patients experienced a dose limiting toxicity on Dose Level 1, thus subjects were enrolled in a Dose Expansion phase.~ETBX-051; adenoviral brachyury vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-061; adenoviral Mucin -1 (MUC1) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine: immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year"
11325985|NCT03384329|BG000|Baseline|Resveratrol Pill|Resveratrol Pill: Resveratrol 500 mg
11325986|NCT03384329|BG001|Baseline|Placebo|Placebos: Placebo Pills
11325987|NCT03384329|BG002|Baseline|Total|Total of all reporting groups
11325988|NCT03384329|FG000|Participant Flow|Resveratrol Pill|Resveratrol Pill: Resveratrol 500 mg
11325989|NCT03384329|FG001|Participant Flow|Placebo|Placebos: Placebo Pills
11325990|NCT03384329|OG000|Outcome|Resveratrol Pill|Resveratrol Pill: Resveratrol 500 mg
11325991|NCT03384329|OG001|Outcome|Placebo|Placebos: Placebo Pills
11325992|NCT03384329|EG000|Reported Event|Resveratrol Pill|Resveratrol Pill: Resveratrol 500 mg
11325993|NCT03384329|EG001|Reported Event|Placebo|Placebos: Placebo Pills
11325994|NCT03384693|BG000|Baseline|Prophylactic Defibrotide|"6.25mg/kg administered intravenously every 6 hours for 28 to 35 days, starting on the day before conditioning is initiated.~Defibrotide: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease."
11325995|NCT03384693|FG000|Participant Flow|Prophylactic Defibrotide|"6.25mg/kg administered intravenously every 6 hours for 28 to 35 days, starting on the day before conditioning is initiated.~Defibrotide: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease."
11325996|NCT03384693|OG000|Outcome|Prophylactic Defibrotide|"6.25mg/kg administered intravenously every 6 hours for 28 to 35 days, starting on the day before conditioning is initiated.~Defibrotide: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease."
11325997|NCT03384693|EG000|Reported Event|Prophylactic Defibrotide|"6.25mg/kg administered intravenously every 6 hours for 28 to 35 days, starting on the day before conditioning is initiated.~Defibrotide: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease."
11325998|NCT03384745|BG000|Baseline|M1095 30mg|"M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11325999|NCT03384745|BG001|Baseline|M1095 60mg|"M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326000|NCT03384745|BG002|Baseline|M1095 120mg - Regimen 1|"M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326001|NCT03384745|BG003|Baseline|M1095 120mg - Regimen 2|"M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326002|NCT03384745|BG004|Baseline|Placebo / M1095 120mg|"Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.~Placebo: Placebo contains no active drug."
11326003|NCT03384745|BG005|Baseline|Secukinumab|"Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.~Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A."
11326004|NCT03384745|BG006|Baseline|Total|Total of all reporting groups
11326005|NCT03384745|FG000|Participant Flow|M1095 30mg|"M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.~Subjects with IGA>1 at Week 12 were escalated to receive M1095, 120mg~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326006|NCT03384745|FG001|Participant Flow|M1095 60mg|"M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.~Subjects with IGA>1 at Week 12 were escalated to receive M1095, 120mg~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326007|NCT03384745|FG002|Participant Flow|M1095 120mg - Regimen 1|"M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326008|NCT03384745|FG003|Participant Flow|M1095 120mg - Regimen 2|"M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326009|NCT03384745|FG004|Participant Flow|Placebo / M1095 120mg|"Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.~Placebo: Placebo contains no active drug."
11326010|NCT03384745|FG005|Participant Flow|Secukinumab|"Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.~Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A."
11326011|NCT03384745|OG000|Outcome|M1095 30mg|"M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326012|NCT03384745|OG001|Outcome|M1095 60mg|"M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326013|NCT03384745|OG002|Outcome|M1095 120mg - Normal Load Group|"M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326014|NCT03384745|OG003|Outcome|M1095 120mg - Augmented Load Group|"M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326015|NCT03384745|OG004|Outcome|Placebo|"Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks.~Placebo: Placebo contains no active drug."
11326016|NCT03384745|OG005|Outcome|Secukinumab|"Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks.~Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A."
11326017|NCT03384745|OG002|Outcome|M1095 120mg - Regimen 1|"M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326018|NCT03384745|OG003|Outcome|M1095 120mg - Regimen 2|"M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326019|NCT03384745|OG004|Outcome|Placebo / M1095 120mg|"Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks.~Placebo: Placebo contains no active drug."
11326020|NCT03384745|EG000|Reported Event|Placebo (Week 0 to Week 12)|"Placebo given at Weeks 0, 2, 4 and 8.~Placebo: Placebo contains no active drug."
11326021|NCT03384745|EG001|Reported Event|M1095 30mg (Week 0 to Week 12)|"M1095, 30mg, given at Weeks 0, 2, 4 and 8.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326022|NCT03384745|EG002|Reported Event|M1095 60 mg (Week 0 to Week 12)|"M1095, 60mg, given at Weeks 0, 2, 4 and 8.~M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326023|NCT03384745|EG003|Reported Event|M1095 120mg - Normal Load Group (Week 0 to Week 12)|"M1095, 120 mg, given at Weeks 0, 2, 4 and 8.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326024|NCT03384745|EG004|Reported Event|M1095 120mg - Augmented Load Group (Week 0 to Week 12)|"M1095, 120 mg, given at Weeks 0, 2, 4, 6, 8 and 10.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326025|NCT03384745|EG005|Reported Event|Secukinumab (Week 0 to Week 12)|"Secukinumab, 300mg, given at Weeks 0, 1, 2, 3, 4 and 8.~Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A."
11326026|NCT03384745|EG006|Reported Event|M1095 - All Participants (Week 0 to Week 12 )|"All participants receiving M1095, 30mg, 60mg, or 120mg from Week 0 to Week 12.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326027|NCT03384745|EG007|Reported Event|M1095 - All Participants (Week 12 to Week 52)|"All participants receiving M1095, 30mg, 60mg, or 120mg from Week 12 to Week 44, including subjects randomised to placebo, who received M1095 120mg from Weeks 12, 14, 16, 20, etc.~M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F."
11326028|NCT03384745|EG008|Reported Event|Secukinumab (Week 12 to Week 52)|"Secukinumab, 300mg, given at Weeks 12, 16, 20 and every 4 weeks to week 44)~Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A."
11326029|NCT03384940|BG000|Baseline|DS-8201a Cohort A|Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
11326030|NCT03384940|BG001|Baseline|DS-8201a Cohort B|Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
11326031|NCT03384940|BG002|Baseline|DS-8201a Cohort C|Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
11326032|NCT03384940|BG003|Baseline|Total|Total of all reporting groups
11326033|NCT03384940|FG000|Participant Flow|DS-8201a Cohort A|Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
11326034|NCT03384940|FG001|Participant Flow|DS-8201a Cohort B|Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
11326035|NCT03384940|FG002|Participant Flow|DS-8201a Cohort C|Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
11326036|NCT03384940|OG000|Outcome|DS-8201a Cohort A|Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
11326037|NCT03384940|OG001|Outcome|DS-8201a Cohort B|Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
11326038|NCT03384940|OG002|Outcome|DS-8201a Cohort C|Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
11326039|NCT03384940|EG000|Reported Event|DS-8201a Cohort A|Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
11326040|NCT03384940|EG001|Reported Event|DS-8201a Cohort B|Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
11326041|NCT03384940|EG002|Reported Event|DS-8201a Cohort C|Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
11326042|NCT03384953|BG000|Baseline|Clinical Hypnosis - Group Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Group Treatment: group treatment"
11333597|NCT03519204|BG002|Baseline|Total|Total of all reporting groups
11333598|NCT03519204|FG000|Participant Flow|No-treatment Control|No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
11333599|NCT03519204|FG001|Participant Flow|JUVÉDERM® VOLBELLA® XC With Lidocaine|JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
11333600|NCT03519204|OG000|Outcome|No-treatment Control|No-treatment was administered during control period.
11333601|NCT03519204|OG001|Outcome|JUVÉDERM® VOLBELLA® XC With Lidocaine|JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
11333602|NCT03519204|OG000|Outcome|JUVÉDERM® VOLBELLA® XC With Lidocaine|JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
11333603|NCT03519204|OG000|Outcome|Treated Control|No-treatment was administered during control period. After 3 months, participants received treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
11333604|NCT03519204|OG000|Outcome|No-treatment Control (Control Period)|No-treatment was administered during control period.
11333605|NCT03519204|OG001|Outcome|JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)|"JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.~Includes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months."
11333606|NCT03519204|EG000|Reported Event|No-treatment Control (Control Period)|No-treatment was administered during control period.
11333607|NCT03519204|EG001|Reported Event|JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)|"JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.~Includes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months."
11333608|NCT03519243|BG000|Baseline|BCD-131 1,05 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333609|NCT03519243|BG001|Baseline|BCD-131 1,7 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333610|NCT03519243|BG002|Baseline|Mircera|"subcutaneously monthly~Mircera: subcutaneously monthly"
11333611|NCT03519243|BG003|Baseline|Total|Total of all reporting groups
11333612|NCT03519243|FG000|Participant Flow|BCD-131 1,05 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333613|NCT03519243|FG001|Participant Flow|BCD-131 1,7 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333614|NCT03519243|FG002|Participant Flow|BCD-131 2,75 mcg/kg * Conversion Ratio|"Subcutaneously monthly~BCD-131: subcutaneously monthly"
11333615|NCT03519243|FG003|Participant Flow|Mircera|"subcutaneously monthly~Mircera: subcutaneously monthly"
11333616|NCT03519243|OG000|Outcome|BCD-131 1,05 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333617|NCT03519243|OG001|Outcome|BCD-131 1,7 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333618|NCT03519243|OG002|Outcome|Mircera|"subcutaneously monthly~Mircera: subcutaneously monthly"
11333619|NCT03519243|EG000|Reported Event|BCD-131 1,05 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333620|NCT03519243|EG001|Reported Event|BCD-131 1,7 mcg/kg * Conversion Ratio|"subcutaneously monthly~BCD-131: subcutaneously monthly"
11333621|NCT03519243|EG002|Reported Event|Mircera|"subcutaneously monthly~Mircera: subcutaneously monthly"
11333622|NCT03519282|BG000|Baseline|Comfilcon A and Omafilcon A Multifocal Toric Lenses|Subjects were randomized to wear the comfilcon A multifocal toric (test) or omafilcon A multifocal toric (control) lens, either as first or second lens during this cross over study.
11333623|NCT03519282|FG000|Participant Flow|Test Multifocal Toric Lens Then Control Multifocal Toric|"Subjects were randomized to wear the test multifocal toric lens then control multifocal toric lens during this crossover study.~comfilcon A multifocal toric lens: contact lens"
11333624|NCT03519282|FG001|Participant Flow|Control Multifocal Toric Lens Then Test Multifocal Toric|"Subjects were randomized to wear the control multifocal toric lens then test multifocal toric lens during this crossover study.~omafilcon A Multifocal Toric Lens: contact lens"
11333625|NCT03519282|OG000|Outcome|Test Multifocal Toric Lens|"Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study.~comfilcon A multifocal toric lens: contact lens"
11333626|NCT03519282|OG001|Outcome|Control Multifocal Toric Lens|"Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study.~omafilcon A Multifocal Toric Lens: contact lens"
11333627|NCT03519282|EG000|Reported Event|Test Multifocal Toric Lens|"Subjects were randomized to wear the comfilcon A multifocal toric lens, either as first or second lens during this crossover study.~comfilcon A multifocal toric lens: contact lens~omafilcon A Multifocal Toric Lens: contact lens"
11333628|NCT03519282|EG001|Reported Event|Omafilcon A Multifocal Toric Lens|"Subjects were randomized to wear the omafilcon A Multifocal Toric Lens, either as first or second lens during this crossover study.~Control multifocal toric lens~comfilcon A multifocal toric lens: contact lens~omafilcon A Multifocal Toric Lens: contact lens"
11333629|NCT03519516|BG000|Baseline|PRO-174|"Active ingredient: Levofloxacin 0.5%~o Dosage: 1 drop in both eyes, 8 times a day during the waking period~PRO-174: Pharmaceutical form: ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333630|NCT03519516|BG001|Baseline|Sophixín Ofteno®|"o Dosage: 1 drop in both eyes, 8 times a day during the waking period~Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%~Pharmaceutical form: Ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333631|NCT03519516|BG002|Baseline|Total|Total of all reporting groups
11333632|NCT03519516|FG000|Participant Flow|PRO-174|"Active ingredient: Levofloxacin 0.5%~o Dosage: 1 drop in both eyes, 8 times a day during the waking period~PRO-174: Pharmaceutical form: ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333633|NCT03519516|FG001|Participant Flow|Sophixín Ofteno®|"o Dosage: 1 drop in both eyes, 8 times a day during the waking period~Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%~Pharmaceutical form: Ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333634|NCT03519516|OG000|Outcome|PRO-174|"Active ingredient: Levofloxacin 0.5%~o Dosage: 1 drop in both eyes, 8 times a day during the waking period~PRO-174: Pharmaceutical form: ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333635|NCT03519516|OG001|Outcome|Sophixín Ofteno®|"o Dosage: 1 drop in both eyes, 8 times a day during the waking period~Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%~Pharmaceutical form: Ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333636|NCT03519516|EG000|Reported Event|PRO-174|"Active ingredient: Levofloxacin 0.5%~o Dosage: 1 drop in both eyes, 8 times a day during the waking period~PRO-174: Pharmaceutical form: ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333637|NCT03519516|EG001|Reported Event|Sophixín Ofteno®|"o Dosage: 1 drop in both eyes, 8 times a day during the waking period~Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%~Pharmaceutical form: Ophthalmic solution~Prepared by: Laboratorios Sophia, S.A. of C.V.~Description of the solution: transparent solution, free of visible particles.~Description of container: sterile multi-dose bottle"
11333638|NCT03519854|BG000|Baseline|Arm A. Placebo; Given 3 Minutes After Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333639|NCT03519854|BG001|Baseline|Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333640|NCT03519854|BG002|Baseline|Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333641|NCT03519854|BG003|Baseline|Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333642|NCT03519854|BG004|Baseline|Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333643|NCT03519854|BG005|Baseline|Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333644|NCT03519854|BG006|Baseline|Arm G. Placebo; Given 5 Minutes After Esmeron®|Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333645|NCT03519854|BG007|Baseline|Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333646|NCT03519854|BG008|Baseline|Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333647|NCT03519854|BG009|Baseline|Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333648|NCT03519854|BG010|Baseline|Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333649|NCT03519854|BG011|Baseline|Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333650|NCT03519854|BG012|Baseline|Arm M. Placebo; Given 15 Minutes After Esmeron®|Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333651|NCT03519854|BG013|Baseline|Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333652|NCT03519854|BG014|Baseline|Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333653|NCT03519854|BG015|Baseline|Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333654|NCT03519854|BG016|Baseline|Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333655|NCT03519854|BG017|Baseline|Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333656|NCT03519854|BG018|Baseline|Total|Total of all reporting groups
11333657|NCT03519854|FG000|Participant Flow|Arm A. Placebo; Given 3 Minutes After Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333658|NCT03519854|FG001|Participant Flow|Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326043|NCT03384953|BG001|Baseline|Clinical Hypnosis - Individual Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Individual Treatment: individual treatment"
11326044|NCT03384953|BG002|Baseline|Total|Total of all reporting groups
11326045|NCT03384953|FG000|Participant Flow|Clinical Hypnosis - Group Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Group Treatment: group treatment"
11326046|NCT03384953|FG001|Participant Flow|Clinical Hypnosis - Individual Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Individual Treatment: individual treatment"
11326047|NCT03384953|OG000|Outcome|Clinical Hypnosis - Group Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Group Treatment: group treatment"
11326048|NCT03384953|OG001|Outcome|Clinical Hypnosis - Individual Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Individual Treatment: individual treatment"
11326049|NCT03384953|EG000|Reported Event|Clinical Hypnosis - Group Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Group Treatment: group treatment"
11326050|NCT03384953|EG001|Reported Event|Clinical Hypnosis - Individual Treatment|"Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.~Clinical Hypnosis - Individual Treatment: individual treatment"
11326051|NCT03384966|BG000|Baseline|Selatogrel 8 mg|Selatogrel (ACT-246475) 8 mg was administered as a single subcutaneous dose.
11326052|NCT03384966|BG001|Baseline|Selatogrel 16 mg|Selatogrel (ACT-246475) 16 mg was administered as a single subcutaneous dose.
11326053|NCT03384966|BG002|Baseline|Placebo|Matching placebo was administered as a single subcutaneous dose.
11326054|NCT03384966|BG003|Baseline|Total|Total of all reporting groups
11326055|NCT03384966|FG000|Participant Flow|Selatogrel 8 mg|"The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.~A participant that met all inclusion criteria and none of the exclusion criteria was randomized.~In the treatment period 8 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.~The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35)."
11326056|NCT03384966|FG001|Participant Flow|Selatogrel 16 mg|"The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.~A participant that met all inclusion criteria and none of the exclusion criteria was randomized.~In the treatment period 16 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.~The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35)."
11326057|NCT03384966|FG002|Participant Flow|Placebo|"The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.~A participant that met all inclusion criteria and none of the exclusion criteria was randomized.~In the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.~The follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35)."
11326058|NCT03384966|OG000|Outcome|Selatogrel 8 mg|Selatogrel 8 mg was administered as a single subcutaneous dose.
11326059|NCT03384966|OG001|Outcome|Selatogrel 16 mg|Selatogrel 16 mg was administered as a single subcutaneous dose.
11326060|NCT03384966|OG002|Outcome|Placebo|Matching placebo was administered as a single subcutaneous dose.
11326061|NCT03384966|OG000|Outcome|Selatogrel 8 mg (Thigh)|Selatogrel 8 mg was administered as a single subcutaneous dose.
11326062|NCT03384966|OG001|Outcome|Selatogrel 8 mg (Abdomen)|Selatogrel 8 mg was administered as a single subcutaneous dose.
11326063|NCT03384966|OG002|Outcome|Selatogrel 16 mg (Thigh)|Selatogrel 16 mg was administered as a single subcutaneous dose.
11326064|NCT03384966|OG003|Outcome|Selatogrel 16 mg (Abdomen)|Selatogrel 16 mg was administered as a single subcutaneous dose.
11326065|NCT03384966|OG004|Outcome|Placebo (Thigh)|Matching placebo was administered as a single subcutaneous dose.
11326066|NCT03384966|OG005|Outcome|Placebo (Abdomen)|Matching placebo was administered as a single subcutaneous dose.
11326067|NCT03384966|EG000|Reported Event|Treatment Period - Selatogrel 8 mg|In the treatment period 8 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
11326068|NCT03384966|EG001|Reported Event|Treatment Period - Selatogrel 16 mg|In the treatment period 16 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
11326069|NCT03384966|EG002|Reported Event|Treatment Period - Placebo|In the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.
11326070|NCT03384966|EG003|Reported Event|Follow-up Period - Selatogrel 8 mg|Participants that had been administered a single subcutaneous injection containing 8 mg selatogrel in the treatment period were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
11326071|NCT03384966|EG004|Reported Event|Follow-up Period - Selatogrel 16 mg|Participants that had been administered a single subcutaneous injection containing 16 mg selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
11326072|NCT03384966|EG005|Reported Event|Follow-up Period - Placebo|Participants that had been administered a single subcutaneous injection containing placebo matching selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.
11326073|NCT03386032|BG000|Baseline|Investigational OTC Cream|"Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.~Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer."
11326074|NCT03386032|BG001|Baseline|Placebo Cream|"Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326075|NCT03386032|BG002|Baseline|0.05% Desonide Cream|"Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326076|NCT03386032|BG003|Baseline|Total|Total of all reporting groups
11326077|NCT03386032|FG000|Participant Flow|Investigational OTC Cream|"Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.~Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer."
11326078|NCT03386032|FG001|Participant Flow|Placebo Cream|"Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326079|NCT03386032|FG002|Participant Flow|0.05% Desonide Cream|"Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326080|NCT03386032|OG000|Outcome|Investigational OTC Cream|"Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.~Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer."
11326081|NCT03386032|OG001|Outcome|Placebo Cream|"Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326082|NCT03386032|OG002|Outcome|0.05% Desonide Cream|"Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326083|NCT03386032|EG000|Reported Event|Investigational OTC Cream|"Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.~Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer."
11326084|NCT03386032|EG001|Reported Event|Placebo Cream|"Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326085|NCT03386032|EG002|Reported Event|0.05% Desonide Cream|"Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.~Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer."
11326086|NCT03386110|BG000|Baseline|Couples Health Project (CHP)|Participants who received the intervention condition, CHP
11326087|NCT03386110|BG001|Baseline|Education|Participants who received the attention-matched Education control
11326088|NCT03386110|BG002|Baseline|Total|Total of all reporting groups
11326089|NCT03386110|FG000|Participant Flow|Couples Health Project (CHP)|Participants who received the intervention condition, CHP
11326090|NCT03386110|FG001|Participant Flow|Education|Participants who received the attention-matched Education control
11326091|NCT03386110|OG000|Outcome|Couples Health Project (CHP)|Participants who received the intervention condition, CHP
11326092|NCT03386110|OG001|Outcome|Education|Participants who received the attention-matched Education control
11326093|NCT03386110|EG000|Reported Event|Couples Health Project (CHP)|Participants who received the intervention condition, CHP
11326094|NCT03386110|EG001|Reported Event|Education|Participants who received the attention-matched Education control
11326095|NCT03386344|BG000|Baseline|Placebo|Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
11326096|NCT03386344|BG001|Baseline|Sotagliflozin 200 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326097|NCT03386344|BG002|Baseline|Sotagliflozin 400 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326098|NCT03386344|BG003|Baseline|Total|Total of all reporting groups
11326099|NCT03386344|FG000|Participant Flow|Placebo|Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
11326100|NCT03386344|FG001|Participant Flow|Sotagliflozin 200 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326101|NCT03386344|FG002|Participant Flow|Sotagliflozin 400 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326102|NCT03386344|OG000|Outcome|Placebo|Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
11326103|NCT03386344|OG001|Outcome|Sotagliflozin 200 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326104|NCT03386344|OG002|Outcome|Sotagliflozin 400 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326105|NCT03386344|EG000|Reported Event|Placebo|Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
11326106|NCT03386344|EG001|Reported Event|Sotagliflozin 200 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326107|NCT03386344|EG002|Reported Event|Sotagliflozin 400 mg|Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
11326108|NCT03386435|BG000|Baseline|RIPC|"intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.~remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated"
11326109|NCT03386435|BG001|Baseline|Control|In the control group, the same maneuver was applied but without cuff inflation.
11326110|NCT03386435|BG002|Baseline|Total|Total of all reporting groups
11326111|NCT03386435|FG000|Participant Flow|RIPC Group|"received remote ischemic preconditioning~remote ischemic preconditioning: transient brief episodes of ischemia at a remote site before a subsequent prolonged ischemia/reperfusion injury of the target organ"
11326112|NCT03386435|FG001|Participant Flow|Control Group|no intervention
11326113|NCT03386435|OG000|Outcome|RIPC|"intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.~remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated"
11326114|NCT03386435|OG001|Outcome|Control|In the control group, the same maneuver was applied but without cuff inflation.
11326115|NCT03386435|EG000|Reported Event|RIPC|"intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.~remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated"
11326116|NCT03386435|EG001|Reported Event|Control|In the control group, the same maneuver was applied but without cuff inflation.
11326117|NCT03386448|BG000|Baseline|Control(Placebo)|"Participants will receive placebo medication~placebo arm: participants will receive placebo medications"
11326118|NCT03386448|BG001|Baseline|Active(Scopolamine and Naltrexone)|"participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.~Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops"
11326119|NCT03386448|BG002|Baseline|Total|Total of all reporting groups
11326120|NCT03386448|FG000|Participant Flow|Control(Placebo)|"Participants will receive placebo medication~placebo arm: participants will receive placebo medications"
11326121|NCT03386448|FG001|Participant Flow|Active(Scopolamine and Naltrexone)|"participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.~Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops"
11326122|NCT03386448|OG000|Outcome|Control(Placebo)|"Participants will receive placebo medication~placebo arm: participants will receive placebo medications"
11326123|NCT03386448|OG001|Outcome|Active(Scopolamine and Naltrexone)|"participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.~Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops"
11326124|NCT03386448|EG000|Reported Event|Control(Placebo)|"Participants will receive placebo medication~placebo arm: participants will receive placebo medications"
11326125|NCT03386448|EG001|Reported Event|Active(Scopolamine and Naltrexone)|"participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.~Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops"
11326126|NCT03386474|BG000|Baseline|Brolucizumab - Overall Extension Study|Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326127|NCT03386474|BG001|Baseline|Aflibercept|Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial.
11326128|NCT03386474|BG002|Baseline|Total|Total of all reporting groups
11326129|NCT03386474|FG000|Participant Flow|Brolucizumab - Overall Extension Study|Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326130|NCT03386474|FG001|Participant Flow|Aflibercept|Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial.
11326131|NCT03386474|OG000|Outcome|Brolucizumab - Overall Extension Study|Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326132|NCT03386474|OG001|Outcome|Brolucizumab Overall Last 6 Months From Core Study|AEs with a start date on or after the date of Core study Week 68 visit were counted
11326133|NCT03386474|OG000|Outcome|Brolucizumab 6 mg - 3 mg in Core Study|Subjects treated with brolucizumab 3 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326134|NCT03386474|OG001|Outcome|Brolucizumab 6 mg - 6 mg in Core Study|Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326135|NCT03386474|OG002|Outcome|Brolucizumab - Overall Extension Study|Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326136|NCT03386474|OG001|Outcome|Brolucizumab 6 mg- 6 mg in Core Study|Subjects treated with brolucizumab 6 mg in Core study and given new formulation 6 mg in Extension study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326137|NCT03386474|EG000|Reported Event|Brolucizumab 6mg Overall Extension Study|Subjects treated with brolucizumab 3 mg or brolucizumab 6 mg in the Core study. All subjects received IVT injection at the extension Baseline, Week 8 and, depending on disease activity as assessed by the investigator, at Week 16 or Week 20.
11326138|NCT03386474|EG001|Reported Event|Brolucizumab Overall Last 6 Months Core Study|AEs with a start date on or after the date of Core study Week 68 visit were counted.
11326139|NCT03386474|EG002|Reported Event|Aflibercept 2 mg|Subjects previously treated with aflibercept 2 mg in the Core study continued to receive aflibercept 2mg IVT injection at the extension Baseline, Week 8 and Week 16 to maintain the masking in the extension trial.
11326140|NCT03386994|BG000|Baseline|IPF Patients With Predicted FVC <50% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326141|NCT03386994|BG001|Baseline|IPF Patients With Predicted FVC 50-80% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326142|NCT03386994|BG002|Baseline|IPF Patients With Predicted FVC >80% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326143|NCT03386994|BG003|Baseline|Total|Total of all reporting groups
11326144|NCT03386994|FG000|Participant Flow|All Patients With IPF - Overall Population|All patients with Idiopathic Pulmonary Fibrosis (IPF).
11326145|NCT03386994|OG000|Outcome|IPF Patients With Predicted FVC <50% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326146|NCT03386994|OG001|Outcome|IPF Patients With Predicted FVC 50-80% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326147|NCT03386994|OG002|Outcome|IPF Patients With Predicted FVC >80% at T0 - Subgroup|"All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).~Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years)."
11326148|NCT03386994|OG000|Outcome|<-10% FVC Decline|IPF patients with FVC decline less than -10%.
11326149|NCT03386994|OG001|Outcome|From -10 to -5% FVC Decline|IPF patients with FVC decline from -10% to -5%.
11326150|NCT03386994|OG002|Outcome|>-5% FVC Decline|IPF patients with FVC decline more than -5%.
11326151|NCT03386994|OG000|Outcome|<-10% FVC Decline|IPF patients with less than -10% FVC decline.
11326152|NCT03386994|OG001|Outcome|From -10% to -5% FVC Decline|IPF patients with FVC decline from -10% to - 5%.
11326153|NCT03386994|OG001|Outcome|From -10% to -5% FVC Decline|IPF patients with FVC decline from -10% to -5%
11326154|NCT03386994|OG001|Outcome|From -10% to -5% FVC Decline|IPF patients with FVC decline from -10% to -5%.
11326155|NCT03386994|OG002|Outcome|>-5% FVC Decline|IPF patients with FVC decline more than -5%
11326156|NCT03386994|OG000|Outcome|Caregivers|Caregivers of patients with Idiopathic Pulmonary Fibrosis.
11326157|NCT03386994|EG000|Reported Event|All Patients With IPF - Overall Population|All patients with Idiopathic Pulmonary Fibrosis (IPF).
11326158|NCT03387020|BG000|Baseline|Phase I, Dose Level 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326159|NCT03387020|BG001|Baseline|Phase I, Dose Level 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326160|NCT03387020|BG002|Baseline|Surgical|Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1.
11326161|NCT03387020|BG003|Baseline|Total|Total of all reporting groups
11326162|NCT03387020|FG000|Participant Flow|Phase I, Dose Level 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326163|NCT03387020|FG001|Participant Flow|Phase I, Dose Level 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326164|NCT03387020|FG002|Participant Flow|Surgical|Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1.
11326165|NCT03387020|OG000|Outcome|DLT Evaluable Set|Patients either from Phase I stratum and received treatment from beginning, or from Surgical stratum who subsequently received Phase I defined treatment would be evaluable for MTD as long as they received sufficient Phase I defined treatment. Of the patients enrolled in Phase I stratum, 11 of them were evaluable for dose finding assessment. Of the patients enrolled in Surgical stratum, 5 of them were evaluable for dose finding assessment. Therefore, we have total 16 patients evaluable for dose finding assessment, 11 from Phase I stratum and 5 from Surgical stratum.
11326166|NCT03387020|OG000|Outcome|Surgical|Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery
11326167|NCT03387020|OG000|Outcome|Phase I, Dose Level 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326168|NCT03387020|OG001|Outcome|Phase I, Dose Level 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326169|NCT03387020|OG002|Outcome|Surgical|Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1.
11326170|NCT03387020|OG000|Outcome|Dose Level 1, Day 1 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
11326171|NCT03387020|OG001|Outcome|Dose Level 1, Day 17 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.
11326172|NCT03387020|OG002|Outcome|Dose Level 2, Day 1 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
11326173|NCT03387020|OG003|Outcome|Dose Level 2, Day 17 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1
11326174|NCT03387020|OG000|Outcome|Dose Level 1, Day 17 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.
11326175|NCT03387020|OG001|Outcome|Dose Level 1, Day 1 of Course 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 2.
11326176|NCT03387020|OG002|Outcome|Dose Level 2, Day 17 of Course 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.
11326177|NCT03387020|OG003|Outcome|Dose Level 2, Day 1 of Course 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 2.
11326178|NCT03387020|EG000|Reported Event|Phase I, Dose Level 1|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326179|NCT03387020|EG001|Reported Event|Phase I, Dose Level 2|Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day
11326180|NCT03387020|EG002|Reported Event|Surgical|Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1.
11326181|NCT03387033|BG000|Baseline|VR Intervention Session|"The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC.~Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session."
11326182|NCT03387033|FG000|Participant Flow|VR Intervention Session|"The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC.~Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session."
11326183|NCT03387033|OG000|Outcome|VR Intervention Session|"The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC.~Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session."
11326184|NCT03387033|EG000|Reported Event|VR Intervention Session|"The patients will give a pain score as well as fill out GAD-7 and PHQ-9 scores initially. The VR intervention session consists of relaxation narration WITH Virtual Reality session for 20 minutes while wearing the VR device. They will then be again asked to give a pain score and fill out GAD-7, PHQ-9, and PGIC.~Relaxation response and virtual reality (VR) session: A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session."
11326185|NCT03387046|BG000|Baseline|D-aspartate + IFN Beta-1a + Methylprednisolone|Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326186|NCT03387046|BG001|Baseline|Placebo + IFN Beta-1a + Methylprednisolone|Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326187|NCT03387046|BG002|Baseline|Total|Total of all reporting groups
11333659|NCT03519854|FG002|Participant Flow|Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333660|NCT03519854|FG003|Participant Flow|Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333661|NCT03519854|FG004|Participant Flow|Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333662|NCT03519854|FG005|Participant Flow|Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333663|NCT03519854|FG006|Participant Flow|Arm G. Placebo; Given 5 Minutes After Esmeron®|Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333664|NCT03519854|FG007|Participant Flow|Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333665|NCT03519854|FG008|Participant Flow|Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333666|NCT03519854|FG009|Participant Flow|Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333667|NCT03519854|FG010|Participant Flow|Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333668|NCT03519854|FG011|Participant Flow|Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333669|NCT03519854|FG012|Participant Flow|Arm M. Placebo; Given 15 Minutes After Esmeron®|Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333670|NCT03519854|FG013|Participant Flow|Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333671|NCT03519854|FG014|Participant Flow|Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333672|NCT03519854|FG015|Participant Flow|Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333673|NCT03519854|FG016|Participant Flow|Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333674|NCT03519854|FG017|Participant Flow|Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333675|NCT03519854|OG000|Outcome|Arm A. Placebo; Given 3 Minutes After Esmeron®|Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333676|NCT03519854|OG001|Outcome|Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333677|NCT03519854|OG002|Outcome|Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333678|NCT03519854|OG003|Outcome|Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333679|NCT03519854|OG004|Outcome|Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333680|NCT03519854|OG005|Outcome|Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333681|NCT03519854|OG006|Outcome|Arm G. Placebo; Given 5 Minutes After Esmeron®|Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333682|NCT03519854|OG007|Outcome|Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333683|NCT03519854|OG008|Outcome|Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333684|NCT03519854|OG009|Outcome|Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333685|NCT03519854|OG010|Outcome|Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333686|NCT03519854|OG011|Outcome|Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333687|NCT03519854|OG012|Outcome|Arm M. Placebo; Given 15 Minutes After Esmeron®|Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333688|NCT03519854|OG013|Outcome|Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333689|NCT03519854|OG014|Outcome|Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333690|NCT03519854|OG015|Outcome|Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333691|NCT03519854|OG016|Outcome|Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326188|NCT03387046|FG000|Participant Flow|D-aspartate + IFN Beta-1a + Methylprednisolone|Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326189|NCT03387046|FG001|Participant Flow|Placebo + IFN Beta-1a + Methylprednisolone|Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326190|NCT03387046|OG000|Outcome|D-aspartate + IFN Beta-1a + Methylprednisolone|Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326191|NCT03387046|OG001|Outcome|Placebo + IFN Beta-1a + Methylprednisolone|Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326192|NCT03387046|EG000|Reported Event|D-aspartate + IFN Beta-1a + Methylprednisolone|Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326193|NCT03387046|EG001|Reported Event|Placebo + IFN Beta-1a + Methylprednisolone|Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
11326194|NCT03387267|BG000|Baseline|Single-arm Dysphagia Detection System|"An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.~Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result."
11326195|NCT03387267|FG000|Participant Flow|Single-arm Dysphagia Detection System|"An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.~Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result."
11326196|NCT03387267|OG000|Outcome|Single-arm Dysphagia Detection System|"An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.~Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result."
11326197|NCT03387267|OG000|Outcome|Single-arm Dysphagia Detection System|Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
11326198|NCT03387267|EG000|Reported Event|Dysphagia Detection System (DDS)|A trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia. Each patient will go through a series of swallows using 5 Thin-BA boluses, 4 Mild-BA boluses and 4 Mod-BA boluses.
10843010|NCT00251316|EG001|Reported Event|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
11095181|NCT01556724|BG001|Baseline|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11095182|NCT01556724|BG002|Baseline|Total|Total of all reporting groups
11095183|NCT01556724|FG000|Participant Flow|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11326199|NCT03387319|BG000|Baseline|Racialized Stressful Event Recall|Participants in this study arm recalled a stressful event related to race.
11326200|NCT03387319|BG001|Baseline|Non-racialized Stressful Event Recall|Participants in this study arm recalled a stressful event unrelated to race.
11326201|NCT03387319|BG002|Baseline|Total|Total of all reporting groups
11326202|NCT03387319|FG000|Participant Flow|Racialized Stressful Event Recall|Participants in this study arm recalled a stressful event related to race.
11326203|NCT03387319|FG001|Participant Flow|Non-racialized Stressful Event Recall|Participants in this study arm recalled a stressful event unrelated to race.
11326204|NCT03387319|OG000|Outcome|Racialized Stressful Event Recall|Participants in this study arm recalled a stressful event related to race.
11326205|NCT03387319|OG001|Outcome|Non-racialized Stressful Event Recall|Participants in this study arm recalled a stressful event unrelated to race.
11326206|NCT03387319|EG000|Reported Event|Racialized Stressful Event Recall|Participants in this study arm recalled a stressful event related to race.
11326207|NCT03387319|EG001|Reported Event|Non-racialized Stressful Event Recall|Participants in this study arm recalled a stressful event unrelated to race.
11326208|NCT03387462|BG000|Baseline|DOT Diary Optimization Intervention|"DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet~Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet~DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities."
11326209|NCT03387462|FG000|Participant Flow|DOT Diary Optimization Intervention|"DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet~Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet~DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities."
11326210|NCT03387462|OG000|Outcome|DOT Diary Optimization Intervention|"DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet~Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet~DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities."
11326211|NCT03387462|EG000|Reported Event|DOT Diary Optimization Intervention|"DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet~Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet~DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities."
11326212|NCT03387683|BG000|Baseline|Dapagliflozin 10 mg|Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
11326213|NCT03387683|BG001|Baseline|Placebo|Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
11326214|NCT03387683|BG002|Baseline|Total|Total of all reporting groups
11326215|NCT03387683|FG000|Participant Flow|Dapagliflozin 10 mg|Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
11326216|NCT03387683|FG001|Participant Flow|Placebo|Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
11326217|NCT03387683|OG000|Outcome|Dapagliflozin 10 mg|Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
11326218|NCT03387683|OG001|Outcome|Placebo|Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
11326219|NCT03387683|EG000|Reported Event|Dapagliflozin 10 mg|Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
11326220|NCT03387683|EG001|Reported Event|Placebo|Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
11333692|NCT03519854|OG017|Outcome|Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®|Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333693|NCT03519854|EG000|Reported Event|Arm A. Placebo; Given 3 Minutes After Esmeron|Placebo (single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333694|NCT03519854|EG001|Reported Event|Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron|Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333695|NCT03519854|EG002|Reported Event|Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326221|NCT03388008|BG000|Baseline|Standard of Care|"Tacrolimus + Mycophenolate mofetil + prednisone from day 0 through day 365~Tacrolimus: Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326222|NCT03388008|BG001|Baseline|Belatacept-based Immunosuppression|"Belatacept + Tacrolimus + prednisone from day 0 through day 89, then Belatacept + Mycophenolate mofetil + prednisone from day 90 through day 365~Belatacept: Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326223|NCT03388008|BG002|Baseline|Total|Total of all reporting groups
11326224|NCT03388008|FG000|Participant Flow|Standard of Care|"Tacrolimus + Mycophenolate mofetil + prednisone from day 0 through day 365~Tacrolimus: Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326225|NCT03388008|FG001|Participant Flow|Belatacept-based Immunosuppression|"Belatacept + Tacrolimus + prednisone from day 0 through day 89, then Belatacept + Mycophenolate mofetil + prednisone from day 90 through day 365~Belatacept: Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326226|NCT03388008|OG000|Outcome|Standard of Care|"Tacrolimus + Mycophenolate mofetil + prednisone from day 0 through day 365~Tacrolimus: Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11333696|NCT03519854|EG003|Reported Event|Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333697|NCT03519854|EG004|Reported Event|Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron|Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333698|NCT03519854|EG005|Reported Event|Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333699|NCT03519854|EG006|Reported Event|Arm G. Placebo; Given 5 Minutes After Esmeron|Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326227|NCT03388008|OG001|Outcome|Belatacept-based Immunosuppression|"Belatacept + Tacrolimus + prednisone from day 0 through day 89, then Belatacept + Mycophenolate mofetil + prednisone from day 90 through day 365~Belatacept: Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326228|NCT03388008|EG000|Reported Event|Standard of Care|"Tacrolimus + Mycophenolate mofetil + prednisone from day 0 through day 365~Tacrolimus: Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326229|NCT03388008|EG001|Reported Event|Belatacept-based Immunosuppression|"Belatacept + Tacrolimus + prednisone from day 0 through day 89, then Belatacept + Mycophenolate mofetil + prednisone from day 90 through day 365~Belatacept: Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)~ATG: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation~Mycophenolate Mofetil: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation~Methylprednisolone: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses~Prednisone: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365"
11326230|NCT03388164|BG000|Baseline|Escitalopram + RT2CK17|"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326231|NCT03388164|BG001|Baseline|Escitalopram + Placebo|"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326232|NCT03388164|BG002|Baseline|Total|Total of all reporting groups
11326233|NCT03388164|FG000|Participant Flow|Escitalopram + RT2CK17|"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326234|NCT03388164|FG001|Participant Flow|Escitalopram + Placebo|"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326235|NCT03388164|OG000|Outcome|Escitalopram + RT2CK17|"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326236|NCT03388164|OG001|Outcome|Escitalopram + Placebo|"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11333700|NCT03519854|EG007|Reported Event|Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron|Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326237|NCT03388164|EG000|Reported Event|Escitalopram + RT2CK17|"10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326238|NCT03388164|EG001|Reported Event|Escitalopram + Placebo|"10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.~Escitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6."
11326239|NCT03388268|BG000|Baseline|Oral Vancomycin|"125mg of oral vancomycin four times per day~Oral Vancomycin: Oral vancomycin 125mg 4 times per day~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326240|NCT03388268|BG001|Baseline|Placebo|"Placebo four times per day~Placebo: Sugar liquid manufactured to mimic oral vancomycin 125mg~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326241|NCT03388268|BG002|Baseline|Total|Total of all reporting groups
11326242|NCT03388268|FG000|Participant Flow|Oral Vancomycin|"125mg of oral vancomycin four times per day~Oral Vancomycin: Oral vancomycin 125mg 4 times per day~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326243|NCT03388268|FG001|Participant Flow|Placebo|"Placebo four times per day~Placebo: Sugar liquid manufactured to mimic oral vancomycin 125mg~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326244|NCT03388268|OG000|Outcome|Oral Vancomycin|"125mg of oral vancomycin four times per day~Oral Vancomycin: Oral vancomycin 125mg 4 times per day~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326245|NCT03388268|OG001|Outcome|Placebo|"Placebo four times per day~Placebo: Sugar liquid manufactured to mimic oral vancomycin 125mg~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326246|NCT03388268|EG000|Reported Event|Oral Vancomycin|"125mg of oral vancomycin four times per day~Oral Vancomycin: Oral vancomycin 125mg 4 times per day~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326247|NCT03388268|EG001|Reported Event|Placebo|"Placebo four times per day~Placebo: Sugar liquid manufactured to mimic oral vancomycin 125mg~Toxin enzyme immunoassay: EIA assay: Wampole/Tech Lab Tox A/B II~Nuceleic acid amplification test: NAAT: Xpert C. difficile, Cepheid"
11326248|NCT03388294|BG000|Baseline|PC Followed by SR|Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
11326249|NCT03388294|BG001|Baseline|SR Followed by PC|Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
11326250|NCT03388294|BG002|Baseline|Total|Total of all reporting groups
11326251|NCT03388294|FG000|Participant Flow|PC Followed by SR|"Parents will first be coached to respond to their infant's pre-linguistic communication (PC) cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity (SR) cues.~Parents and Infants Engaged (PIE): A parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other neurodevelopmental disorders (NDs) on the one hand, and parent responses to infant cues on the other hand."
11326252|NCT03388294|FG001|Participant Flow|SR Followed by PC|"Parents will first be coached to respond to their infant's sensory reactivity (SR) cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication (PC) cues.~Parents and Infants Engaged (PIE): A parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other neurodevelopmental disorders (NDs) on the one hand, and parent responses to infant cues on the other hand."
11326253|NCT03388294|OG000|Outcome|PC Followed by SR|Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
11326254|NCT03388294|OG001|Outcome|SR Followed by PC|Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
11326255|NCT03388294|EG000|Reported Event|PC Followed by SR|Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues
11326256|NCT03388294|EG001|Reported Event|SR Followed by PC|Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
11326257|NCT03388645|BG000|Baseline|Low Dose 10^6.3 PFU of RSV A2|Single intranasal dose of 10^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326258|NCT03388645|BG001|Baseline|High Dose 10^7 PFU of RSV A2|Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326259|NCT03388645|BG002|Baseline|Total|Total of all reporting groups
11326260|NCT03388645|FG000|Participant Flow|Low Dose 10^6.3 PFU of RSV A2|Single intranasal dose of 10^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326261|NCT03388645|FG001|Participant Flow|High Dose 10^7 PFU of RSV A2|Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326262|NCT03388645|OG000|Outcome|Low Dose 10^6.3 PFU of RSV A2|Single intranasal dose of 10^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326263|NCT03388645|OG001|Outcome|High Dose 10^7 PFU of RSV A2|Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326264|NCT03388645|EG000|Reported Event|Low Dose 10^6.3 PFU of RSV A2|Single intranasal dose of 10^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326265|NCT03388645|EG001|Reported Event|High Dose 10^7 PFU of RSV A2|Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
11326266|NCT03389308|BG000|Baseline|Diacerein 1% Ointment|Subjects with active lesions as determined Investigator's clinical assessment, will apply diacerein 1% ointment once-daily, to their EBS lesions for 8 weeks. Following an off treatment period of 8 weeks or more, subjects may enter into another Treatment Period of 8 weeks. The subject's participation may range from 32 weeks to 52 weeks.
11326267|NCT03389308|FG000|Participant Flow|Diacerein 1% Ointment|Subjects with active lesions as determined Investigator's clinical assessment, will apply diacerein 1% ointment once-daily, to their EBS lesions for 8 weeks. Following an off treatment period of 8 weeks or more, subjects may enter into another Treatment Period of 8 weeks. The subject's participation may range from 32 weeks to 52 weeks.
11326268|NCT03389308|OG000|Outcome|Diacerein 1% Ointment|Subjects with active lesions as determined Investigator's clinical assessment, will apply diacerein 1% ointment once-daily, to their EBS lesions for 8 weeks. Following an off treatment period of 8 weeks or more, subjects may enter into another Treatment Period of 8 weeks. The subject's participation may range from 32 weeks to 52 weeks.
11326269|NCT03389308|EG000|Reported Event|Diacerein 1% Ointment|Subjects with active lesions as determined Investigator's clinical assessment, will apply diacerein 1% ointment once-daily, to their EBS lesions for 8 weeks. Following an off treatment period of 8 weeks or more, subjects may enter into another Treatment Period of 8 weeks. The subject's participation may range from 32 weeks to 52 weeks.
11326270|NCT03389555|BG000|Baseline|Vitamin C, Vitamin B1, Corticosteroids|"The combination of vitamin C, vitamin B1, hydrocortisone :~Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU."
11326271|NCT03389555|BG001|Baseline|Placebo|"Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components"
11326272|NCT03389555|BG002|Baseline|Total|Total of all reporting groups
11326273|NCT03389555|FG000|Participant Flow|Vitamin C, Vitamin B1, Corticosteroids|"The combination of vitamin C, vitamin B1, hydrocortisone :~Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU."
11326274|NCT03389555|FG001|Participant Flow|Placebo|"Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components"
11326275|NCT03389555|OG000|Outcome|Vitamin C, Vitamin B1, Corticosteroids|"The combination of vitamin C, vitamin B1, hydrocortisone :~Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU."
11326276|NCT03389555|OG001|Outcome|Placebo|"Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components"
11326277|NCT03389555|EG000|Reported Event|Vitamin C, Vitamin B1, Corticosteroids|"The combination of vitamin C, vitamin B1, hydrocortisone :~Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU."
11326278|NCT03389555|EG001|Reported Event|Placebo|"Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components"
11326279|NCT03389854|BG000|Baseline|Control Group|No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired.
11326280|NCT03389854|BG001|Baseline|Penile Traction Therapy Group 1x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326281|NCT03389854|BG002|Baseline|Penile Traction Therapy Group 2x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326282|NCT03389854|BG003|Baseline|Penile Traction Therapy Group 3x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326283|NCT03389854|BG004|Baseline|Total|Total of all reporting groups
11326284|NCT03389854|FG000|Participant Flow|Control Group|No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired.
11326285|NCT03389854|FG001|Participant Flow|Penile Traction Therapy Group 1x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326286|NCT03389854|FG002|Participant Flow|Penile Traction Therapy Group 2x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326287|NCT03389854|FG003|Participant Flow|Penile Traction Therapy Group 3x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326288|NCT03389854|OG000|Outcome|Penile Traction Therapy Group 1x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326289|NCT03389854|OG001|Outcome|Penile Traction Therapy Group 2x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326290|NCT03389854|OG002|Outcome|Penile Traction Therapy Group 3x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326291|NCT03389854|OG000|Outcome|Open Label Period Penile Traction Therapy|After the initial 3 month study period subjects from both the control group and the penile traction therapy group will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326292|NCT03389854|OG000|Outcome|Open Label Penile Traction Therapy|After the initial 3 month study period subjects from both the control group and the penile traction therapy group will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326293|NCT03389854|OG000|Outcome|Control Group|No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired.
11326294|NCT03389854|OG001|Outcome|Penile Traction Therapy Group|RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
11326295|NCT03389854|OG000|Outcome|Penile Traction Therapy Group|RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
11326296|NCT03389854|EG000|Reported Event|Penile Traction Therapy Group 1x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326297|NCT03389854|EG001|Reported Event|Penile Traction Therapy Group 2x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326298|NCT03389854|EG002|Reported Event|Penile Traction Therapy Group 3x Daily x 3 Months|Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326299|NCT03389854|EG003|Reported Event|Open Label Period Penile Traction Therapy|After the initial 3 month study period subjects from both the control group and the penile traction therapy group will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
11326300|NCT03389893|BG000|Baseline|Dupilumab+Open Label Extension and Follow-Up|Participants received a loading dose of two 300 mg subcutaneous injections on Day 0 followed by 300 mg subcutaneous injections every two weeks (Days 14 and 28). Participants started a 10 week OLE on Day 42, beginning with a loading dose of two subcutaneously administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326301|NCT03389893|BG001|Baseline|Placebo+Open Label Extension and Follow-Up|Placebo contained the identical formulation as the dupilumab formulation without the active monoclonal antibody and was given by exactly the same route and schedule through Day 28. Participants started a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcutaneous injections [total of 600 mg]-protection of prior masking/blind maintained). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326302|NCT03389893|BG002|Baseline|Total|Total of all reporting groups
11326303|NCT03389893|FG000|Participant Flow|Dupilumab|Participants received a loading dose of two 300 mg subcutaneous injections on Day 0 followed by 300 mg subcutaneous injections every two weeks (Days 14 and 28).
11326304|NCT03389893|FG001|Participant Flow|Placebo|Placebo contained the identical formulation as the dupilumab formulation without the active monoclonal antibody and was given by exactly the same route and schedule through Day 28.
11326305|NCT03389893|FG002|Participant Flow|Dupilumab to Open-Label Extension Dupilumab|Open Label Extension (OLE): Participants started a 10 week OLE on Day 42, beginning with a loading dose of two subcutaneously administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11333701|NCT03519854|EG008|Reported Event|Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333702|NCT03519854|EG009|Reported Event|Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326306|NCT03389893|FG003|Participant Flow|Placebo to Open-Label Extension Dupilumab|Open Label Extension (OLE): Participants started a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcutaneous injections [total of 600 mg]-protection of prior masking/blind maintained). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326307|NCT03389893|OG000|Outcome|Dupilumab+Open Label Extension and Follow-Up|Participants received a loading dose of two 300 mg subcutaneous injections on Day 0 followed by 300 mg subcutaneous injections every two weeks (Days 14 and 28). Participants started a 10 week OLE on Day 42, beginning with a loading dose of two subcutaneously administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326308|NCT03389893|OG001|Outcome|Placebo+Open Label Extension and Follow-Up|Placebo contained the identical formulation as the dupilumab formulation without the active monoclonal antibody and was given by exactly the same route and schedule through Day 28. Participants started a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcutaneous injections [total of 600 mg]-protection of prior masking/blind maintained). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326309|NCT03389893|EG000|Reported Event|Dupilumab+Open Label Extension and Follow-Up|Participants received a loading dose of two 300 mg subcutaneous injections on Day 0 followed by 300 mg subcutaneous injections every two weeks (Days 14 and 28). Participants started a 10 week OLE on Day 42, beginning with a loading dose of two subcutaneously administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326310|NCT03389893|EG001|Reported Event|Placebo+Open Label Extension and Follow-Up|Placebo contained the identical formulation as the dupilumab formulation without the active monoclonal antibody and was given by exactly the same route and schedule through Day 28. Participants started a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcutaneous injections [total of 600 mg]-protection of prior masking/blind maintained). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182.
11326311|NCT03390114|BG000|Baseline|SHUTi Cognitive Behavioral Therapy|"SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.~SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points."
11326312|NCT03390114|BG001|Baseline|Usual Care|Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
11326313|NCT03390114|BG002|Baseline|Total|Total of all reporting groups
11326314|NCT03390114|FG000|Participant Flow|SHUTi Cognitive Behavioral Therapy|"SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.~SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points."
11326315|NCT03390114|FG001|Participant Flow|Usual Care|Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
11326316|NCT03390114|OG000|Outcome|SHUTi Cognitive Behavioral Therapy|"SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.~SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points."
11326317|NCT03390114|OG001|Outcome|Usual Care|Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
11326318|NCT03390114|EG000|Reported Event|SHUTi Cognitive Behavioral Therapy|"SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.~SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points."
11326319|NCT03390114|EG001|Reported Event|Usual Care|Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
11333703|NCT03519854|EG010|Reported Event|Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron|Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326320|NCT03390166|BG000|Baseline|GPO Tri Fluvac Vaccine|"630 volunteers will receive a single dose of the seasonal trivalent inactivated influenza vaccine (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) produced by GPO Thailand. To be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.~GPO Tri Fluvac vaccine: The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326321|NCT03390166|BG001|Baseline|Licensed Influenza Vaccine|"315 volunteers will receive acLicensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2017 (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.~Licensed influenza vaccine: The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326322|NCT03390166|BG002|Baseline|Total|Total of all reporting groups
11326323|NCT03390166|FG000|Participant Flow|GPO Tri Fluvac Vaccine|"630 volunteers will receive a single dose of the seasonal trivalent inactivated influenza vaccine (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) produced by GPO Thailand. To be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.~GPO Tri Fluvac vaccine: The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326324|NCT03390166|FG001|Participant Flow|Licensed Influenza Vaccine|"315 volunteers will receive acLicensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2017 (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.~Licensed influenza vaccine: The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326325|NCT03390166|OG000|Outcome|GPO Tri Fluvac Vaccine|"630 volunteers will receive a single dose of the seasonal trivalent inactivated influenza vaccine (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) produced by GPO Thailand. To be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.~GPO Tri Fluvac vaccine: The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326326|NCT03390166|OG001|Outcome|Licensed Influenza Vaccine|"315 volunteers will receive acLicensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2017 (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.~Licensed influenza vaccine: The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326327|NCT03390166|EG000|Reported Event|GPO Tri Fluvac Vaccine|"630 volunteers will receive a single dose of the seasonal trivalent inactivated influenza vaccine (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) produced by GPO Thailand. To be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.~GPO Tri Fluvac vaccine: The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326328|NCT03390166|EG001|Reported Event|Licensed Influenza Vaccine|"315 volunteers will receive acLicensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2017 (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.~Licensed influenza vaccine: The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm."
11326329|NCT03390257|BG000|Baseline|3nt Flexible Endoscope|The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
11326330|NCT03390257|FG000|Participant Flow|3NT Flexible Endoscope|"Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy~3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation"
11326331|NCT03390257|OG000|Outcome|3NT Flexible Endoscope|"Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy~3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation~No Adverse events were reported during this study."
11326332|NCT03390257|OG000|Outcome|3NT Flexible Endoscope|"Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy~3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation"
11326333|NCT03390257|OG000|Outcome|3NT Flexible Endoscope|3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
11326334|NCT03390257|EG000|Reported Event|3NT Flexible Endoscope|"Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy~3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation~No Adverse events were reported during this study."
11326335|NCT03390426|BG000|Baseline|Mepivacaine Block Group|"Injection of local anesthetic (mepivacaine) above and beside the femoral artery.~Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively."
11333704|NCT03519854|EG011|Reported Event|Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326336|NCT03390426|BG001|Baseline|Saline Sham Group|"Injection of salt water (saline) above and beside the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.~Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water."
11326337|NCT03390426|BG002|Baseline|Total|Total of all reporting groups
11326338|NCT03390426|FG000|Participant Flow|Mepivacaine Block Group|"Injection of local anesthetic (mepivacaine) above and beside the femoral artery.~Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively."
11326339|NCT03390426|FG001|Participant Flow|Saline Sham Group|"Injection of salt water (saline) above and beside the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.~Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water."
11326340|NCT03390426|OG000|Outcome|Mepivacaine Block Group|"Injection of local anesthetic (mepivacaine) above and beside the femoral artery.~Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively."
11326341|NCT03390426|OG001|Outcome|Saline Sham Group|"Injection of salt water (saline) above and beside the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.~Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water."
11326342|NCT03390426|EG000|Reported Event|Mepivacaine Block Group|"Injection of local anesthetic (mepivacaine) above and beside the femoral artery.~Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively."
11326343|NCT03390426|EG001|Reported Event|Saline Sham Group|"Injection of salt water (saline) above and beside the femoral artery.~Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.~Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water."
11326344|NCT03390842|BG000|Baseline|TRC101 Treatment Arm|TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326345|NCT03390842|BG001|Baseline|Placebo Treatment Arm|Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326346|NCT03390842|BG002|Baseline|Total|Total of all reporting groups
11326347|NCT03390842|FG000|Participant Flow|TRC101 Treatment Arm|TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326348|NCT03390842|FG001|Participant Flow|Placebo Treatment Arm|Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326349|NCT03390842|OG000|Outcome|TRC101 Treatment Arm|TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326350|NCT03390842|OG001|Outcome|Placebo Treatment Arm|Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326351|NCT03390842|EG000|Reported Event|TRC101 Treatment Arm|TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11333705|NCT03519854|EG012|Reported Event|Arm M. Placebo; Given 15 Minutes After Esmeron|Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11333706|NCT03519854|EG013|Reported Event|Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron|Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326352|NCT03390842|EG001|Reported Event|Placebo Treatment Arm|Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
11326353|NCT03390907|BG000|Baseline|Hybrid APC|"Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.~Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease."
11326354|NCT03390907|FG000|Participant Flow|Hybrid APC|"Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.~Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease."
11326355|NCT03390907|OG000|Outcome|Hybrid APC|"Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.~Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.~0% of recurrence in 32 cases who completed post-procedure colonoscopy 6 month follow-up."
11326356|NCT03390907|OG000|Outcome|Hybrid APC|"Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.~Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease."
11326357|NCT03390907|EG000|Reported Event|Hybrid APC|"Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.~Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease."
11326358|NCT03391115|BG000|Baseline|Inpatient Participants|"Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:~Heart Failure~COPD~Cancer~Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR."
11326359|NCT03391115|BG001|Baseline|Nurse Participants|"Bedside nurses who provide care at the inpatient level for the following diseases:~Heart Failure~COPD~Cancer~Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the strength of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material."
11326360|NCT03391115|BG002|Baseline|Total|Total of all reporting groups
11326361|NCT03391115|FG000|Participant Flow|Inpatient Participants|"Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:~Heart Failure~COPD~Cancer~Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR."
11326362|NCT03391115|FG001|Participant Flow|Nurse Participants|"Bedside nurses who provide care at the inpatient level for the following diseases:~Heart Failure~COPD~Cancer~Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the strength of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material."
11326363|NCT03391115|OG000|Outcome|Inpatient Participants|"Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:~Heart Failure~COPD~Cancer~Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR."
11326364|NCT03391115|OG001|Outcome|Nurse Participants|"Bedside nurses who provide care at the inpatient level for the following diseases:~Heart Failure~COPD~Cancer~Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the strength of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material."
11326365|NCT03391115|EG000|Reported Event|Inpatient Participants|"Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:~Heart Failure~COPD~Cancer~Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR."
11326366|NCT03391115|EG001|Reported Event|Nurse Participants|"Bedside nurses who provide care at the inpatient level for the following diseases:~Heart Failure~COPD~Cancer~Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the strength of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material."
11326367|NCT03391765|BG000|Baseline|M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326368|NCT03391765|BG001|Baseline|M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326369|NCT03391765|BG002|Baseline|M15-562 Placebo/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326370|NCT03391765|BG003|Baseline|M15-562 Placebo/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326371|NCT03391765|BG004|Baseline|Total|Total of all reporting groups
11326372|NCT03391765|FG000|Participant Flow|M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326373|NCT03391765|FG001|Participant Flow|M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326374|NCT03391765|FG002|Participant Flow|M15-562 Placebo/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326375|NCT03391765|FG003|Participant Flow|M15-562 Placebo/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326376|NCT03391765|OG000|Outcome|M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326377|NCT03391765|OG001|Outcome|M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326378|NCT03391765|OG002|Outcome|M15-562 Placebo/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326379|NCT03391765|OG003|Outcome|M15-562 Placebo/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326380|NCT03391765|EG000|Reported Event|M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326381|NCT03391765|EG001|Reported Event|M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
11326382|NCT03391765|EG002|Reported Event|M15-562 Placebo/M15-563 ABBV-8E12 2000 mg|Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326383|NCT03391765|EG003|Reported Event|M15-562 Placebo/M15-563 ABBV-8E12 4000 mg|Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
11326384|NCT03391986|BG000|Baseline|Pyonex Needles|"This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.~SEIRIN® Pyonex™ Acupuncture Needles: Needles will be placed on the right and left ear.~Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326385|NCT03391986|BG001|Baseline|Placebo Adhesives|"This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.~12 mm Plasters: 12 mm (0.5). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326386|NCT03391986|BG002|Baseline|Routine Care|This arm will receive no intervention.
11326387|NCT03391986|BG003|Baseline|Total|Total of all reporting groups
11326388|NCT03391986|FG000|Participant Flow|Pyonex Needles|"This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.~SEIRIN® Pyonex™ Acupuncture Needles: Needles will be placed on the right and left ear.~Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326389|NCT03391986|FG001|Participant Flow|Placebo Adhesives|"This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.~12 mm Plasters: 12 mm (0.5). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326390|NCT03391986|FG002|Participant Flow|Routine Care|This arm will receive no intervention.
11326391|NCT03391986|OG000|Outcome|Pyonex Needles|"This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.~SEIRIN® Pyonex™ Acupuncture Needles: Needles will be placed on the right and left ear.~Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326392|NCT03391986|OG001|Outcome|Routine Care|This arm will receive no intervention.
11326393|NCT03391986|OG000|Outcome|Placebo Adhesives|"This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.~12 mm Plasters: 12 mm (0.5). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326394|NCT03391986|EG000|Reported Event|Pyonex Needles|"This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.~SEIRIN® Pyonex™ Acupuncture Needles: Needles will be placed on the right and left ear.~Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326395|NCT03391986|EG001|Reported Event|Placebo Adhesives|"This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.~12 mm Plasters: 12 mm (0.5). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
11326396|NCT03391986|EG002|Reported Event|Routine Care|This arm will receive no intervention.
11326397|NCT03392168|BG000|Baseline|Cohort 1 - ARQ-151 Cream 0.5%|Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
11326398|NCT03392168|BG001|Baseline|Cohort 2 - ARQ-151 Cream 0.5%|ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326399|NCT03392168|BG002|Baseline|Cohort 2 - ARQ-151 Cream 0.15%|ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326400|NCT03392168|BG003|Baseline|Cohort 2 - ARQ-151 Vehicle Cream|Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326401|NCT03392168|BG004|Baseline|Total|Total of all reporting groups
11326402|NCT03392168|FG000|Participant Flow|Cohort 1 - ARQ-151 Cream 0.5%|Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
11326403|NCT03392168|FG001|Participant Flow|Cohort 2 - ARQ-151 Cream 0.5%|ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326404|NCT03392168|FG002|Participant Flow|Cohort 2 - ARQ-151 Cream 0.15%|ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326405|NCT03392168|FG003|Participant Flow|Cohort 2 - ARQ-151 Vehicle Cream|Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326406|NCT03392168|OG000|Outcome|Cohort 2 - ARQ-151 Cream 0.5%|ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326407|NCT03392168|OG001|Outcome|Cohort 2 - ARQ-151 Cream 0.15%|ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326408|NCT03392168|OG002|Outcome|Cohort 2 - ARQ-151 Vehicle Cream|Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326409|NCT03392168|EG000|Reported Event|Cohort 1 - ARQ-151 Cream 0.5%|Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
11326410|NCT03392168|EG001|Reported Event|Cohort 2 - ARQ-151 Cream 0.5%|ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326411|NCT03392168|EG002|Reported Event|Cohort 2 - ARQ-151 Cream 0.15%|ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326412|NCT03392168|EG003|Reported Event|Cohort 2 - ARQ-151 Vehicle Cream|Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
11326413|NCT03392194|BG000|Baseline|Sleep Hygiene & Yoga (SH+Y)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.~Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks)."
11326414|NCT03392194|BG001|Baseline|Sleep Hygiene (SH)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal."
11326415|NCT03392194|BG002|Baseline|Total|Total of all reporting groups
11326416|NCT03392194|FG000|Participant Flow|Sleep Hygiene & Yoga (SH+Y)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.~Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks)."
11326417|NCT03392194|FG001|Participant Flow|Sleep Hygiene (SH)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal."
11326418|NCT03392194|OG000|Outcome|Sleep Hygiene & Yoga (SH+Y)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.~Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks)."
11326419|NCT03392194|OG001|Outcome|Sleep Hygiene (SH)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal."
11326420|NCT03392194|EG000|Reported Event|Sleep Hygiene & Yoga (SH+Y)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.~Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks)."
11326421|NCT03392194|EG001|Reported Event|Sleep Hygiene (SH)|"Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.~Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal."
11326422|NCT03392532|BG000|Baseline|Overall|Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment
11326423|NCT03392532|FG000|Participant Flow|AOHG Toric, Then AO Toric|Lotrafilcon B toric contact lenses with HYDRAGLYDE®, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
11326424|NCT03392532|FG001|Participant Flow|AO Toric, Then AOHG Toric|Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE®, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
11326425|NCT03392532|OG000|Outcome|AOHG Toric|Lotrafilcon B toric contact lenses with HYDRAGLYDE® worn in both eyes for approximately 30 minutes during either Period 1 or Period 2, as randomized
11326426|NCT03392532|OG001|Outcome|AO Toric|Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized
11326427|NCT03392532|EG000|Reported Event|AOHG Toric|All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized
11326428|NCT03392532|EG001|Reported Event|AO Toric|All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized
11326429|NCT03392935|BG000|Baseline|All Subjects|"All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.~1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4."
11333707|NCT03519854|EG014|Reported Event|Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron|Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326430|NCT03392935|FG000|Participant Flow|All Subjects|"All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.~1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4."
11326431|NCT03392935|OG000|Outcome|All Subjects|"All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.~1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4."
11326432|NCT03392935|EG000|Reported Event|All Subjects|"All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.~1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4."
11326433|NCT03392974|BG000|Baseline|BMN 270 4E13 vg/kg|Single administration of valoctocogene roxaparvovec at a dose of 4E13 vg/kg
11326434|NCT03392974|FG000|Participant Flow|BMN 270 4E13 vg/kg|Single administration of valoctocogene roxaparvovec at a dose of 4E13 vg/kg
11326435|NCT03392974|OG000|Outcome|BMN 270 4E13 vg/kg|Single administration of valoctocogene roxaparvovec at a dose of 4E13 vg/kg
11326436|NCT03392974|EG000|Reported Event|BMN 270 4E13 vg/kg|Single administration of valoctocogene roxaparvovec at a dose of 4E13 vg/kg
11326437|NCT03392974|EG001|Reported Event|Total|Total
11326438|NCT03393000|BG000|Baseline|Trans Sodium Crocetinate Plus SOC|"Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide~Trans Sodium Crocetinate plus SOC: Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide"
11326439|NCT03393000|FG000|Participant Flow|Trans Sodium Crocetinate Plus SOC|"Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide~Trans Sodium Crocetinate plus SOC: Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide"
11326440|NCT03393000|OG000|Outcome|Trans Sodium Crocetinate Plus SOC|"Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide~Trans Sodium Crocetinate plus SOC: Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide"
11326441|NCT03393000|EG000|Reported Event|Trans Sodium Crocetinate Plus SOC|"Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide~Trans Sodium Crocetinate plus SOC: Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide"
11326442|NCT03393208|BG000|Baseline|First Test GIR (Fasting), Then Reference GIR (Fasting)|Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
11326443|NCT03393208|BG001|Baseline|First Reference GIR (Fasting), Then Test GIR (Fasting)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
11326444|NCT03393208|BG002|Baseline|First Test GIR (Fed), Then Reference GIR (Fed)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
11326445|NCT03393208|BG003|Baseline|First Reference GIR (Fed), Then Test GIR (Fed)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
11326446|NCT03393208|BG004|Baseline|Total|Total of all reporting groups
11326447|NCT03393208|FG000|Participant Flow|First Test GIR (Fasting), Then Reference GIR (Fasting)|Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
11326448|NCT03393208|FG001|Participant Flow|First Reference GIR (Fasting), Then Test GIR (Fasting)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
11326449|NCT03393208|FG002|Participant Flow|First Test GIR (Fed), Then Reference GIR (Fed)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
11326450|NCT03393208|FG003|Participant Flow|First Reference GIR (Fed), Then Test GIR (Fed)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
11326451|NCT03393208|OG000|Outcome|Treatment A: Test GIR (Fasting)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
11326452|NCT03393208|OG001|Outcome|Treatment B Reference GIR (Fasting)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
11326453|NCT03393208|OG002|Outcome|Treatment A: Test GIR (Fed)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
11326454|NCT03393208|OG003|Outcome|Treatment B: Reference GIR (Fed)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
11326455|NCT03393208|OG001|Outcome|Treatment B Reference GIR (Fasting|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
11326456|NCT03393208|OG000|Outcome|Treatment A: Test GIR (Fasting)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions
11326457|NCT03393208|EG000|Reported Event|Treatment A Test GIR (Fasting)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
11326458|NCT03393208|EG001|Reported Event|Treatment B Reference GIR (Fasting)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
11326459|NCT03393208|EG002|Reported Event|Treatment A: Test GIR (Fed)|Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
11326460|NCT03393208|EG003|Reported Event|Treatment B: Reference GIR (Fed)|Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
11326461|NCT03393494|BG000|Baseline|Perrigo Active|"Test product~Adapalene and Benzoyl Peroxide Topical Gel: Test product"
11326462|NCT03393494|BG001|Baseline|Reference Active|"RLD product~Epiduo Topical Product: RLD product"
11326463|NCT03393494|BG002|Baseline|Perrigo Placebo|"placebo product~Placebo: Placebo gel"
11326464|NCT03393494|BG003|Baseline|Total|Total of all reporting groups
11326465|NCT03393494|FG000|Participant Flow|Test Product|Adapalene and Benzoyl Peroxide Topical Gel
11326466|NCT03393494|FG001|Participant Flow|Reference Product|Epiduo Topical Gel
11326467|NCT03393494|FG002|Participant Flow|Placebo Product|Placebo gel
11326468|NCT03393494|OG000|Outcome|Perrigo Active|"Test product~Adapalene and Benzoyl Peroxide Topical Gel: Test product"
11326469|NCT03393494|OG001|Outcome|Reference Active|"RLD product~Epiduo Topical Product: RLD product"
11326470|NCT03393494|OG002|Outcome|Perrigo Placebo|"placebo product~Placebo: Placebo gel"
11326471|NCT03393494|EG000|Reported Event|Perrigo Active|"Test product~Adapalene and Benzoyl Peroxide Topical Gel: Test product"
11326472|NCT03393494|EG001|Reported Event|Reference Active|"RLD product~Epiduo Topical Product: RLD product"
11326473|NCT03393494|EG002|Reported Event|Perrigo Placebo|"placebo product~Placebo: Placebo gel"
11326474|NCT03393754|BG000|Baseline|Engerix-B® Hepatitis B Vaccination|"Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326475|NCT03393754|BG001|Baseline|Sci-B-Vac® Hepatitis B Vaccination|"Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326476|NCT03393754|BG002|Baseline|Total|Total of all reporting groups
11326477|NCT03393754|FG000|Participant Flow|Engerix-B® Hepatitis B Vaccination|"Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326478|NCT03393754|FG001|Participant Flow|Sci-B-Vac® Hepatitis B Vaccination|"Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326479|NCT03393754|OG000|Outcome|Engerix-B® Hepatitis B Vaccination|"Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326480|NCT03393754|OG001|Outcome|Sci-B-Vac® Hepatitis B Vaccination|"Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326481|NCT03393754|EG000|Reported Event|Engerix-B® Hepatitis B Vaccination|"Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326482|NCT03393754|EG001|Reported Event|Sci-B-Vac® Hepatitis B Vaccination|"Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination"
11326483|NCT03393806|BG000|Baseline|Placebo|Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326484|NCT03393806|BG001|Baseline|GSK3772847|Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326485|NCT03393806|BG002|Baseline|Total|Total of all reporting groups
11326486|NCT03393806|FG000|Participant Flow|Placebo|Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326487|NCT03393806|FG001|Participant Flow|GSK3772847|Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326488|NCT03393806|OG000|Outcome|Placebo|Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326489|NCT03393806|OG001|Outcome|GSK3772847|Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326490|NCT03393806|OG000|Outcome|GSK3772847|Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326491|NCT03393806|EG000|Reported Event|Placebo|Participants received three doses of placebo administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326492|NCT03393806|EG001|Reported Event|GSK3772847|Participants received three doses of GSK3772847 10 mg/kg administered intravenously every 4 weeks (Weeks 0, 4 and 8) along with their standard of care treatment.
11326493|NCT03394391|BG000|Baseline|Intervention Group|"Daily ART-adherence SMS reminder~Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326494|NCT03394391|BG001|Baseline|Control Group|"Standard adherence counselling/Patient experience group chat~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326495|NCT03394391|BG002|Baseline|Total|Total of all reporting groups
11326496|NCT03394391|FG000|Participant Flow|Intervention Group|"Daily ART-adherence SMS reminder~Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326497|NCT03394391|FG001|Participant Flow|Control Group|"Standard adherence counselling/Patient experience group chat~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326498|NCT03394391|OG000|Outcome|Intervention Group|"Daily ART-adherence SMS reminder~Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326499|NCT03394391|OG001|Outcome|Control Group|"Standard adherence counselling/Patient experience group chat~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326500|NCT03394391|EG000|Reported Event|Intervention Group|"Daily ART-adherence SMS reminder~Daily ART-adherence SMS reminder: Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326501|NCT03394391|EG001|Reported Event|Control Group|"Standard adherence counselling/Patient experience group chat~Standard Adherence Counselling/Patient experience group chat: All the participants will receive the standard adherence counselling by trained counsellors at each visit.~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
11326502|NCT03394508|BG000|Baseline|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"
11326503|NCT03394508|BG001|Baseline|Active Treatment|"Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.~ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season."
11326504|NCT03394508|BG002|Baseline|Total|Total of all reporting groups
11326505|NCT03394508|FG000|Participant Flow|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"
11333708|NCT03519854|EG015|Reported Event|Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron|Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326506|NCT03394508|FG001|Participant Flow|Active Treatment|"Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension~ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season"
11326507|NCT03394508|OG000|Outcome|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"
11326508|NCT03394508|OG001|Outcome|Active Treatment|"Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension~ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season."
11326509|NCT03394508|OG000|Outcome|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0,1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval."
11326510|NCT03394508|OG001|Outcome|Active Treatment|"Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.~ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season."
11326511|NCT03394508|OG000|Outcome|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0,1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"
11326512|NCT03394508|OG000|Outcome|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"
11326513|NCT03394508|EG000|Reported Event|Placebo|"ALK diluent 0,3% human albumin'~ALK diluent 0.1 ml human albumin: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval"
11326514|NCT03394508|EG001|Reported Event|Active Treatment|"Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension~ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection before the second pollen season."
11326515|NCT03394768|BG000|Baseline|All Participants|"Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.~No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed"
11326516|NCT03394768|FG000|Participant Flow|All Participants|"Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.~No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed"
11326517|NCT03394768|OG000|Outcome|All Participants|"Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.~No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed"
11326518|NCT03394768|EG000|Reported Event|All Participants|"Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.~No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed"
11326519|NCT03394885|BG000|Baseline|Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)|"Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by~Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by~Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).~(Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles~Atezolizumab: 1200mg IV q3weeks~Carboplatin: 5-6mg/ML IV q3 weeks~Paclitaxel: 70-80 mg/m2 IV q1 week~Bevacizumab: 15 mg/kg IV q3 weeks"
11326520|NCT03394885|FG000|Participant Flow|Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)|"Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by~Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by~Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).~(Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles~Atezolizumab: 1200mg IV q3weeks~Carboplatin: 5-6mg/ML IV q3 weeks~Paclitaxel: 70-80 mg/m2 IV q1 week~Bevacizumab: 15 mg/kg IV q3 weeks"
11333709|NCT03519854|EG016|Reported Event|Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron|Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326521|NCT03394885|OG000|Outcome|Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)|"Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by~Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by~Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).~(Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles~Atezolizumab: 1200mg IV q3weeks~Carboplatin: 5-6mg/ML IV q3 weeks~Paclitaxel: 70-80 mg/m2 IV q1 week~Bevacizumab: 15 mg/kg IV q3 weeks"
11326522|NCT03394885|EG000|Reported Event|Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)|"Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by~Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by~Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing).~(Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles~Atezolizumab: 1200mg IV q3weeks~Carboplatin: 5-6mg/ML IV q3 weeks~Paclitaxel: 70-80 mg/m2 IV q1 week~Bevacizumab: 15 mg/kg IV q3 weeks"
11326523|NCT03394924|BG000|Baseline|EDP-305 1 mg|Participants took EDP-305 1 mg as an oral tablet once daily for 12 weeks.
11326524|NCT03394924|BG001|Baseline|EDP-305 2.5 mg|Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.
11326525|NCT03394924|BG002|Baseline|Placebo|Participants received an oral placebo matching EDP-305 once daily for 12 weeks.
11326526|NCT03394924|BG003|Baseline|Total|Total of all reporting groups
11326527|NCT03394924|FG000|Participant Flow|EDP-305 1 mg|Participants took EDP-305 1 milligrams (mg) as an oral tablet once daily for 12 weeks.
11326528|NCT03394924|FG001|Participant Flow|EDP-305 2.5 mg|Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.
11326529|NCT03394924|FG002|Participant Flow|Placebo|Participants received an oral placebo matching EDP-305 once daily for 12 weeks.
11326530|NCT03394924|OG000|Outcome|EDP-305 1 mg|Participants took EDP-305 1 mg as an oral tablet once daily for 12 weeks.
11326531|NCT03394924|OG001|Outcome|EDP-305 2.5 mg|Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.
11326532|NCT03394924|OG002|Outcome|Placebo|Participants received an oral placebo matching EDP-305 once daily for 12 weeks.
11326533|NCT03394924|OG000|Outcome|EDP-305 1 mg - Pharmacokinetic Substudy|Participants took EDP-305 1 mg as an oral tablet once daily for 12 weeks.
11326534|NCT03394924|OG001|Outcome|EDP-305 2.5 mg - Pharmacokinetic Substudy|Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.
10827901|NCT00112294|OG001|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
11326535|NCT03394924|EG000|Reported Event|EDP-305 1 mg|Participants took EDP-305 1 mg as an oral tablet once daily for 12 weeks.
11326536|NCT03394924|EG001|Reported Event|EDP-305 2.5 mg|Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.
11326537|NCT03394924|EG002|Reported Event|Placebo|Participants received an oral placebo matching EDP-305 once daily for 12 weeks.
11326538|NCT03395353|BG000|Baseline|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
11326539|NCT03395353|FG000|Participant Flow|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
11326540|NCT03395353|OG000|Outcome|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
11326541|NCT03395353|OG000|Outcome|Duloxetine 40 mg (9 to 11 Years Old)|Trough concentrations of duloxetine 40mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
11326542|NCT03395353|OG001|Outcome|Duloxetine 40 mg (12 to 17 Years Old)|Trough concentrations of duloxetine 40mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
11326543|NCT03395353|OG002|Outcome|Duloxetine 60 mg (9 to 11 Years Old)|Trough concentrations of duloxetine 60mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
11326544|NCT03395353|OG003|Outcome|Duloxetine 60 mg (12 to 17 Years Old)|Trough concentrations of duloxetine 60mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
10827902|NCT00112294|EG000|Reported Event|Cetuximab+Taxane+Carboplatin|
11326545|NCT03395353|EG000|Reported Event|Duloxetine|20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
11326546|NCT03395808|BG000|Baseline|AVE-901 50mg|"IV Tramadol~Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses"
11326547|NCT03395808|FG000|Participant Flow|AVE-901 50mg|"IV Tramadol~Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses"
11326548|NCT03395808|OG000|Outcome|IV Tramadol 50 mg|50 mg IV tramadol given at 0, 2, 4 hours and every 4 hours after
11326549|NCT03395808|EG000|Reported Event|AVE-901 50mg|"IV Tramadol~Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses"
11326550|NCT03395886|BG000|Baseline|Remifentanil Group|"Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min.~Remifentanil: The noninvasive ventilation intolerated patients was sedated by remifentanil."
11326551|NCT03395886|BG001|Baseline|Dexmedetomidine Group|"Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h.~Dexmedetomidine: The noninvasive ventilation intolerated patients was sedated by dexmeditomidine."
11326552|NCT03395886|BG002|Baseline|Total|Total of all reporting groups
11326553|NCT03395886|FG000|Participant Flow|Remifentanil Group|"Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min.~Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil."
11326554|NCT03395886|FG001|Participant Flow|Dexmedetomidine Group|"Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h.~Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine."
11326555|NCT03395886|OG000|Outcome|Remifentanil Group|"Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min.~Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil."
11326556|NCT03395886|OG001|Outcome|Dexmedetomidine Group|"Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h.~Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine."
11326557|NCT03395886|EG000|Reported Event|Remifentanil Group|"Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min.~Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil."
11326558|NCT03395886|EG001|Reported Event|Dexmedetomidine Group|"Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h.~Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine."
11326559|NCT03395990|BG000|Baseline|Chloroprocaine|"15 ml of 2% chloroprocaine via a femoral nerve block technique~Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326560|NCT03395990|BG001|Baseline|Saline|"15 ml of 0.9% saline via a femoral nerve block technique~Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326561|NCT03395990|BG002|Baseline|Total|Total of all reporting groups
11326562|NCT03395990|FG000|Participant Flow|Chloroprocaine|"15 ml of 2% chloroprocaine via a femoral nerve block technique~Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326563|NCT03395990|FG001|Participant Flow|Saline|"15 ml of 0.9% saline via a femoral nerve block technique~Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326564|NCT03395990|OG000|Outcome|Chloroprocaine|"15 ml of 2% chloroprocaine via a femoral nerve block technique~Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326565|NCT03395990|OG001|Outcome|Saline|"15 ml of 0.9% saline via a femoral nerve block technique~Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326566|NCT03395990|EG000|Reported Event|Chloroprocaine|"15 ml of 2% chloroprocaine via a femoral nerve block technique~Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
11326567|NCT03395990|EG001|Reported Event|Saline|"15 ml of 0.9% saline via a femoral nerve block technique~Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb."
10827903|NCT00112294|EG001|Reported Event|Taxane+Carboplatin|
11326568|NCT03396432|BG000|Baseline|Video Laryngoscopy for Endotracheal (ET) Placement|"Device:~Storz C-MAC Video Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326569|NCT03396432|BG001|Baseline|Direct Laryngoscopy for ET Placement|"Device:~Miller Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326570|NCT03396432|BG002|Baseline|Total|Total of all reporting groups
11326571|NCT03396432|FG000|Participant Flow|Video Laryngoscopy for Endotracheal (ET) Placement|"Device:~Storz C-MAC Video Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326572|NCT03396432|FG001|Participant Flow|Direct Laryngoscopy for ET Placement|"Device:~Miller Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326573|NCT03396432|OG000|Outcome|Video Laryngoscopy for Endotracheal (ET) Placement|"Device:~Storz C-MAC Video Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326574|NCT03396432|OG001|Outcome|Direct Laryngoscopy for ET Placement|"Device:~Miller Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326575|NCT03396432|OG000|Outcome|Video Laryngoscopy for Endotracheal (ET) Placement|"Device:~Storz C-MAC Video Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope"
11326576|NCT03396432|OG001|Outcome|Direct Laryngoscopy for ET Placement|"Device:~Miller Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326577|NCT03396432|EG000|Reported Event|Video Laryngoscopy for Endotracheal (ET) Placement|"Device:~Storz C-MAC Video Laryngoscope~Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope"
11326578|NCT03396432|EG001|Reported Event|Direct Laryngoscopy for ET Placement|"Device:~Miller Laryngoscope~Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade"
11326579|NCT03396835|BG000|Baseline|INVSENSOR00009 Sensor|All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
11326580|NCT03396835|FG000|Participant Flow|INVSENSOR00009 Sensor|All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
11326581|NCT03396835|OG000|Outcome|INVSENSOR00009 Sensor|All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
11326582|NCT03396835|EG000|Reported Event|INVSENSOR00009 Sensor|All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
11326583|NCT03396913|BG000|Baseline|Sham+MGX|Sham IPL followed by meibomian gland expression (control group)
11326584|NCT03396913|BG001|Baseline|IPL+MGX|Patients treated with IPL followed by meibomian gland expression (study group)
11326585|NCT03396913|BG002|Baseline|Total|Total of all reporting groups
11326586|NCT03396913|FG000|Participant Flow|Sham+MGX|Sham IPL followed by meibomian gland expression (control group)
11326587|NCT03396913|FG001|Participant Flow|IPL+MGX|Patients treated with IPL followed by meibomian gland expression (study group)
11326588|NCT03396913|OG000|Outcome|Sham+MGX|Sham IPL followed by meibomian gland expression (control group)
11326589|NCT03396913|OG001|Outcome|IPL+MGX|Patients treated with IPL followed by meibomian gland expression (study group)
11326590|NCT03396913|EG000|Reported Event|Sham+MGX|Sham IPL followed by meibomian gland expression (control group)
11326591|NCT03396913|EG001|Reported Event|IPL+MGX|Patients treated with IPL followed by meibomian gland expression (study group)
11326592|NCT03397121|BG000|Baseline|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326593|NCT03397121|BG001|Baseline|Placebo|"Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326594|NCT03397121|BG002|Baseline|Total|Total of all reporting groups
11326595|NCT03397121|FG000|Participant Flow|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326596|NCT03397121|FG001|Participant Flow|Placebo|"Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326597|NCT03397121|OG000|Outcome|Inclisiran|Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
11326598|NCT03397121|OG001|Outcome|Placebo|Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
11326599|NCT03397121|OG000|Outcome|Inclisiran|Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.s.
11326600|NCT03397121|EG000|Reported Event|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326601|NCT03397121|EG001|Reported Event|Placebo|"Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326602|NCT03397394|BG000|Baseline|HRD Unknown|Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
11326603|NCT03397394|BG001|Baseline|HRD Negative|Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.
11326604|NCT03397394|BG002|Baseline|HRD Positive|Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
11326605|NCT03397394|BG003|Baseline|Total|Total of all reporting groups
11326606|NCT03397394|FG000|Participant Flow|HRD Unknown|Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
11326607|NCT03397394|FG001|Participant Flow|HRD Negative|Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.
11326608|NCT03397394|FG002|Participant Flow|HRD Positive|Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
11326609|NCT03397394|OG000|Outcome|HRD Unknown|Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
11326610|NCT03397394|OG001|Outcome|HRD Negative|Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.
11326611|NCT03397394|OG002|Outcome|HRD Positive|Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
11326612|NCT03397394|OG003|Outcome|Overall|All patients
11326613|NCT03397394|EG000|Reported Event|HRD Unknown|Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
11326614|NCT03397394|EG001|Reported Event|HRD Negative|Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.
11326615|NCT03397394|EG002|Reported Event|HRD Positive|Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
11326616|NCT03397394|EG003|Reported Event|Overall|All patients
11326617|NCT03397771|BG000|Baseline|Litoxetine Oral Capsules|"oral experimental study medication litoxetine~Litoxetine: oral study medication provided in a dose titration manner"
11326618|NCT03397771|BG001|Baseline|Placebo Oral Capsules|"oral comparator~placebo: placebo medication provided in a dose titration manner"
11326619|NCT03397771|BG002|Baseline|Total|Total of all reporting groups
11326620|NCT03397771|FG000|Participant Flow|Litoxetine Oral Capsules|"oral experimental study medication litoxetine~Litoxetine: oral study medication provided in a dose titration manner"
11326621|NCT03397771|FG001|Participant Flow|Placebo Oral Capsules|"oral comparator~placebo: placebo medication provided in a dose titration manner"
11326622|NCT03397771|OG000|Outcome|Litoxetine Oral Capsules|"oral experimental study medication litoxetine~Litoxetine: oral study medication provided in a dose titration manner"
11326623|NCT03397771|OG001|Outcome|Placebo Oral Capsules|"oral comparator~placebo: placebo medication provided in a dose titration manner"
11326624|NCT03397771|EG000|Reported Event|Litoxetine Oral Capsules|"oral experimental study medication litoxetine~Litoxetine: oral study medication provided in a dose titration manner"
11326625|NCT03397771|EG001|Reported Event|Placebo Oral Capsules|"oral comparator~placebo: placebo medication provided in a dose titration manner"
11326626|NCT03398213|BG000|Baseline|Acupuncture|"Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation~Acupuncture: Acupuncture"
10827904|NCT00112359|BG000|Baseline|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
11326627|NCT03398213|BG001|Baseline|Sham Procedure|"Ear stimulation with plaster + standard conventional care for COPD exacerbation~Sham procedure: Ear stimulation with plaster"
11326628|NCT03398213|BG002|Baseline|Standard Care|Standard conventional care for COPD exacerbation
11326629|NCT03398213|BG003|Baseline|Total|Total of all reporting groups
11326630|NCT03398213|FG000|Participant Flow|Acupuncture|"Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation~Acupuncture: Acupuncture~N=26"
11326631|NCT03398213|FG001|Participant Flow|Sham Procedure|"Ear stimulation with plaster + standard conventional care for COPD exacerbation~Sham procedure: Ear stimulation with plaster~N=24"
11326632|NCT03398213|FG002|Participant Flow|Standard Care|"Standard conventional care for COPD exacerbation~N=22"
11326633|NCT03398213|OG000|Outcome|Acupuncture|"Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation~Acupuncture: Acupuncture"
11326634|NCT03398213|OG001|Outcome|Sham Procedure|"Ear stimulation with plaster + standard conventional care for COPD exacerbation~Sham procedure: Ear stimulation with plaster"
11326635|NCT03398213|OG002|Outcome|Standard Care|Standard conventional care for COPD exacerbation
11326636|NCT03398213|EG000|Reported Event|Acupuncture|"Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation~Acupuncture: Acupuncture"
11326637|NCT03398213|EG001|Reported Event|Sham Procedure|"Ear stimulation with plaster + standard conventional care for COPD exacerbation~Sham procedure: Ear stimulation with plaster"
11326638|NCT03398213|EG002|Reported Event|Standard Care|Standard conventional care for COPD exacerbation
11326639|NCT03398265|BG000|Baseline|Intervention|"Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.~Treatment Navigation (Intervention): Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone."
11333710|NCT03519854|EG017|Reported Event|Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron|Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
11326640|NCT03398265|BG001|Baseline|Control|"Referrals to treatment from corrections staff.~Control: Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone."
11326641|NCT03398265|BG002|Baseline|Total|Total of all reporting groups
11326642|NCT03398265|FG000|Participant Flow|Intervention|"Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.~Treatment Navigation (Intervention): Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone."
11326643|NCT03398265|FG001|Participant Flow|Control|"Referrals to treatment from corrections staff.~Control: Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone."
11326644|NCT03398265|OG000|Outcome|Intervention|"Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.~Treatment Navigation (Intervention): Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone."
11326645|NCT03398265|OG001|Outcome|Control|"Referrals to treatment from corrections staff.~Control: Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone."
11326646|NCT03398265|OG001|Outcome|Control|Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone.
11326647|NCT03398265|EG000|Reported Event|Intervention|"Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.~Treatment Navigation (Intervention): Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone."
11326648|NCT03398265|EG001|Reported Event|Control|"Referrals to treatment from corrections staff.~Control: Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone."
11326649|NCT03398278|BG000|Baseline|OTR 40 Mg-OXYCONTIN 40 mg|the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose
11326650|NCT03398278|BG001|Baseline|OXYCONTIN 40 Mg-OTR 40 mg|the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose
11326651|NCT03398278|BG002|Baseline|Total|Total of all reporting groups
11326652|NCT03398278|FG000|Participant Flow|OTR 40 Mg-OXYCONTIN 40 mg|the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose in fasted state
11326653|NCT03398278|FG001|Participant Flow|OXYCONTIN 40 Mg-OTR 40 mg|the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose in fasted state
11326654|NCT03398278|OG000|Outcome|Cmax of OTR 40 mg|OTR Tablet 40 mg
11326655|NCT03398278|OG001|Outcome|Cmax of OXYCONTIN® 40 mg|OXYCONTIN® Tablet 40 mg
11326656|NCT03398278|OG000|Outcome|AUCt of OTR Tablet 40 mg|OTR Tablet 40 mg
11326657|NCT03398278|OG001|Outcome|AUCt of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326658|NCT03398278|OG000|Outcome|AUCINF of OTR Tablet 40 mg|OTR Tablet 40 mg
11326659|NCT03398278|OG001|Outcome|AUCINF of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326660|NCT03398278|OG000|Outcome|Oxycodone Tamper Resistant (OTR)|"Oxycodone Tamper Resistant (OTR) Tablet 40 mg~Oxycodone Tamper Resistant: Orally taking Oxycodone Tamper Resistant 40mg in fast state"
11326661|NCT03398278|OG001|Outcome|OXYCONTIN®|"OXYCONTIN® Tablet 40 mg~OXYCONTIN®: Orally taking OXYCONTIN® 40mg in fast state"
11326662|NCT03398278|OG000|Outcome|Clinical Laboratory Data of OTR Tablet 40 mg|OTR Tablet 40 mg
11326663|NCT03398278|OG001|Outcome|Clinical Laboratory Data of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326664|NCT03398278|OG000|Outcome|Vital Sign of OTR Tablet 40 mg|OTR tablet 40 mg
11326665|NCT03398278|OG001|Outcome|Vital Sign of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326666|NCT03398278|OG000|Outcome|ECG of OTR Tablet 40 mg|OTR Tablet 40 mg
11326667|NCT03398278|OG001|Outcome|ECG of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326668|NCT03398278|OG000|Outcome|Physical Examination of OTR Tablet 40 mg|OTR Tablet 40 mg
11326669|NCT03398278|OG001|Outcome|Physical Examination of OXYCONTIN Tablet|OXYCONTIN Tablet 40 mg
11326670|NCT03398278|EG000|Reported Event|OTR 40 mg|"Oxycodone Tamper Resistant (OTR) Tablet 40 mg~Oxycodone Tamper Resistant: Orally taking Oxycodone Tamper Resistant 40mg in fast state"
11326671|NCT03398278|EG001|Reported Event|OXYCONTIN® 40 mg|"OXYCONTIN® Tablet 40 mg~OXYCONTIN®: Orally taking OXYCONTIN® 40mg in fast state"
11326672|NCT03398330|BG000|Baseline|OTR 40 Mg-OXYCONTIN 40 mg|the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose
11326673|NCT03398330|BG001|Baseline|OXYCONTIN 40 Mg-OTR 40 mg|the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose in fed
11326674|NCT03398330|BG002|Baseline|Total|Total of all reporting groups
11326675|NCT03398330|FG000|Participant Flow|OTR 40 Mg-OXYCONTIN 40 mg|the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose in fed state
11326676|NCT03398330|FG001|Participant Flow|OXYCONTIN 40 Mg-OTR 40 mg|the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose in fed state
11326677|NCT03398330|OG000|Outcome|Cmax of OTR Tablet 40 mg|OTR Tablet 40 mg
11326678|NCT03398330|OG001|Outcome|Cmax of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326679|NCT03398330|OG000|Outcome|AUCt of OTR Tablet 40 mg|OTR tablet 40 mg
11326680|NCT03398330|OG001|Outcome|AUCt of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326681|NCT03398330|OG000|Outcome|AUCINF of OTR Tablet 40 mg|OTR tablet 40 mg
11326682|NCT03398330|OG001|Outcome|AUCINF of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326683|NCT03398330|OG000|Outcome|Adverse Events of OTR Tablet 40 mg|OTR tablet 40 mg
11326684|NCT03398330|OG001|Outcome|Adverse Events of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326685|NCT03398330|OG000|Outcome|Clinical Laboratory Data of OTR Tablet 40 mg|OTR tablet 40 mg
11326686|NCT03398330|OG001|Outcome|Clinical Laboratory Data of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326687|NCT03398330|OG000|Outcome|Vital Signs of OTR Tablet 40 mg|OTR tablet 40 mg
11326688|NCT03398330|OG001|Outcome|Vital Signs of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326689|NCT03398330|OG000|Outcome|ECG of OTR Tablet 40 mg|OTR tablet 40 mg
11326690|NCT03398330|OG001|Outcome|ECG of OXYCONTIN Tablet 40 mg|OXYCONTIN tablet 40 mg
11326691|NCT03398330|OG000|Outcome|Physical Examination of OTR Tablet 40 mg|OTR Tablet 40 mg
11326692|NCT03398330|OG001|Outcome|Physical Examination of OXYCONTIN Tablet 40 mg|OXYCONTIN Tablet 40 mg
11326693|NCT03398330|EG000|Reported Event|OTR 40mg|"Oxycodone Tamper Resistant (OTR) Tablet 40 mg~Oxycodone Tamper Resistant: Orally taking Oxycodone Tamper Resistant 40mg in fed state"
11326694|NCT03398330|EG001|Reported Event|OXYCONTIN® 40mg|"OXYCONTIN® Tablet 40 mg~OxyContin®: Orally taking OXYCONTIN® 40mg in fed state"
11326695|NCT03398421|BG000|Baseline|All Study Participants|Participants received a single 100 mcg inhaled oral dose of Nemiralisib on Day 1 in Period 1, followed by a washout period of 14 days. In treatment period 2, participants received an oral dose of 200 mg itraconazole from Days 1 to 10 and on Day 5 a single inhaled oral dose of 100 mcg nemiralisib was administered one hour after itraconazole dosing.
11326696|NCT03398421|FG000|Participant Flow|Nemiralisib 100 mcg|Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.
11326697|NCT03398421|FG001|Participant Flow|Itraconazole 200 Milligram(mg) With 100mcg Nemiralisib|After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
11326698|NCT03398421|OG000|Outcome|Nemiralisib 100 mcg|Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.
11326699|NCT03398421|OG001|Outcome|Itraconazole 200 mg and 100mcg Nemiralisib on Day 5|After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
11326700|NCT03398421|OG000|Outcome|Nemiralisib 100 mcg With Itraconazole 200 mg|After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
11326701|NCT03398421|OG000|Outcome|Itraconazole 200 mg and 100mcg Nemiralisib on Day 5|After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
11326702|NCT03398421|EG000|Reported Event|Nemiralisib 100 mcg|Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.
11326703|NCT03398421|EG001|Reported Event|Nemiralisib 100 mcg With Itraconazole 200 mg|After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
11326704|NCT03398798|BG000|Baseline|".014 With Twin Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.014: .014 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326705|NCT03398798|BG001|Baseline|".016 With Twin Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.016: .016 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326706|NCT03398798|BG002|Baseline|".014 With Self-ligating Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.014: .014 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326707|NCT03398798|BG003|Baseline|".016 With Self-ligating Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.016: .016 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326708|NCT03398798|BG004|Baseline|Total|Total of all reporting groups
11326709|NCT03398798|FG000|Participant Flow|".014 With Twin Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.014: .014 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326710|NCT03398798|FG001|Participant Flow|".016 With Twin Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.016: .016 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326711|NCT03398798|FG002|Participant Flow|".014 With Self-ligating Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.014: .014 CuNiTi orthodontic arch wire~Self-ligating (SL) brackets: Ormco Insignia SL brackets"
11326712|NCT03398798|FG003|Participant Flow|".016 With Self-ligating Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.016: .016 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326713|NCT03398798|OG000|Outcome|".014 With Twin Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.014: .014 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326714|NCT03398798|OG001|Outcome|".016 With Twin Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.016: .016 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326715|NCT03398798|OG002|Outcome|".014 With Self-ligating Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.014: .014 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326716|NCT03398798|OG003|Outcome|".016 With Self-ligating Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.016: .016 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326717|NCT03398798|EG000|Reported Event|".014 With Twin Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.014: .014 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326718|NCT03398798|EG001|Reported Event|".016 With Twin Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia Metal Twin brackets.~.016: .016 CuNiTi orthodontic arch wire~Twin brackets: Ormco Insignia Metal Twin brackets"
11326719|NCT03398798|EG002|Reported Event|".014 With Self-ligating Brackets"|".014 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.014: .014 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326720|NCT03398798|EG003|Reported Event|".016 With Self-ligating Brackets"|".016 dimension CuNiTi orthodontic arch wires and .022 slot Ormco Insignia SL (self-ligating) brackets.~.016: .016 CuNiTi orthodontic arch wire~Self-ligating brackets: Ormco Insignia SL brackets"
11326721|NCT03398928|BG000|Baseline|Acupuncture|"Acupuncture for delirium treatment~Acupuncture + Standard care"
11326722|NCT03398928|BG001|Baseline|Standard Care|Standard conventional delirium care at the discretion of the department medical staff
11326723|NCT03398928|BG002|Baseline|Total|Total of all reporting groups
11326724|NCT03398928|FG000|Participant Flow|Acupuncture|"Acupuncture for delirium treatment~Acupuncture + Standard care"
11326725|NCT03398928|FG001|Participant Flow|Standard Care|Standard conventional delirium care at the discretion of the department medical staff
11326726|NCT03398928|OG000|Outcome|Acupuncture|"Acupuncture for delirium treatment~Acupuncture + Standard care"
11326727|NCT03398928|OG001|Outcome|Standard Care|Standard conventional delirium care at the discretion of the department medical staff
11326728|NCT03398928|EG000|Reported Event|Acupuncture|"Acupuncture for delirium treatment~Acupuncture + Standard care"
11326729|NCT03398928|EG001|Reported Event|Standard Care|Standard conventional delirium care at the discretion of the department medical staff
11326730|NCT03399370|BG000|Baseline|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326731|NCT03399370|BG001|Baseline|Placebo|"Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.~Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326732|NCT03399370|BG002|Baseline|Total|Total of all reporting groups
11326733|NCT03399370|FG000|Participant Flow|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326734|NCT03399370|FG001|Participant Flow|Saline Solution|"Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326735|NCT03399370|OG000|Outcome|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326736|NCT03399370|OG001|Outcome|Placebo|Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
11326737|NCT03399370|OG000|Outcome|Inclisiran|Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
11326738|NCT03399370|EG000|Reported Event|Inclisiran|"Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326739|NCT03399370|EG001|Reported Event|Saline Solution|"Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11333711|NCT03519867|BG000|Baseline|1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326740|NCT03399786|BG000|Baseline|Placebo IV Q4W|Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326741|NCT03399786|BG001|Baseline|Evinacumab 15 mg/kg IV Q4W|Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326742|NCT03399786|BG002|Baseline|Total|Total of all reporting groups
11326743|NCT03399786|FG000|Participant Flow|Placebo IV Q4W (DBTP)|Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP).
11326744|NCT03399786|FG001|Participant Flow|Evinacumab 15 mg/kg (DBTP)|Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP).
11326745|NCT03399786|FG002|Participant Flow|Placebo IV Q4W (OLTP)|All participants in the placebo arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326746|NCT03399786|FG003|Participant Flow|Evinacumab 15 mg/kg (OLTP)|All participants in the evinacumab arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326747|NCT03399786|OG000|Outcome|Placebo IV Q4W|Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326748|NCT03399786|OG001|Outcome|Evinacumab 15 mg/kg IV Q4W|Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326749|NCT03399786|EG000|Reported Event|Placebo IV Q4W (DBTP)|Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP).
11326750|NCT03399786|EG001|Reported Event|Evinacumab 15 mg/kg (DBTP)|Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP).
11326751|NCT03399786|EG002|Reported Event|Placebo IV Q4W (OLTP)|All participants in the placebo arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326752|NCT03399786|EG003|Reported Event|Evinacumab 15 mg/kg (OLTP)|All participants in the evinacumab arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
11326753|NCT03400033|BG000|Baseline|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326754|NCT03400033|BG001|Baseline|Epoetin Alfa|Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326755|NCT03400033|BG002|Baseline|Total|Total of all reporting groups
11326756|NCT03400033|FG000|Participant Flow|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326757|NCT03400033|FG001|Participant Flow|Epoetin Alfa|Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326758|NCT03400033|OG000|Outcome|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.
11333712|NCT03519867|BG001|Baseline|2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326759|NCT03400033|OG001|Outcome|Epoetin Alfa|Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326760|NCT03400033|OG000|Outcome|Daprodustat 2 mg|Participants received daprodustat tablets 2 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326761|NCT03400033|OG001|Outcome|Daprodustat 4 mg|Participants received daprodustat tablets 4 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326762|NCT03400033|OG002|Outcome|Daprodustat 8 mg|Participants received daprodustat tablets 8 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326763|NCT03400033|OG003|Outcome|Daprodustat 12 mg|Participants received daprodustat tablets 12 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326764|NCT03400033|OG004|Outcome|Daprodustat 16 mg|Participants received daprodustat tablets 16 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326765|NCT03400033|OG005|Outcome|Daprodustat 20 mg|Participants received daprodustat tablets 20 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326766|NCT03400033|OG006|Outcome|Daprodustat 24 mg|Participants received daprodustat tablets 24 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326767|NCT03400033|OG007|Outcome|Daprodustat 32 mg|Participants received daprodustat tablets 32 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326768|NCT03400033|OG008|Outcome|Daprodustat 48 mg|Participants received daprodustat tablets 48 mg orally three-times weekly at the time of the pharmacokinetic visit.
11326769|NCT03400033|EG000|Reported Event|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326770|NCT03400033|EG001|Reported Event|Epoetin Alfa|Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.
11326771|NCT03400163|BG000|Baseline|BMS-986036 20 mg QD|Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting
11326772|NCT03400163|BG001|Baseline|Placebo 20 mg QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11326773|NCT03400163|BG002|Baseline|Total|Total of all reporting groups
11326774|NCT03400163|FG000|Participant Flow|BMS-986036 20 mg QD|Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting
11326775|NCT03400163|FG001|Participant Flow|Placebo 20 mg QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11326776|NCT03400163|OG000|Outcome|BMS-986036 20 mg QD|Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting
11326777|NCT03400163|OG001|Outcome|Placebo 20 mg QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11326778|NCT03400163|EG000|Reported Event|BMS-986036 20 mg QD|Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting
11326779|NCT03400163|EG001|Reported Event|Placebo 20 mg QD|Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
11326780|NCT03400449|BG000|Baseline|Video Counseling|"The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.~Video counseling: Video counseling"
11326781|NCT03400449|BG001|Baseline|Conversational Counseling|"The conversation group participated in a structured, face-to-face conversation with a trained counselor.~Conversational counseling: Conversational counseling"
11326782|NCT03400449|BG002|Baseline|Total|Total of all reporting groups
11326783|NCT03400449|FG000|Participant Flow|Video Counseling|"The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.~Video counseling: Video counseling"
11326784|NCT03400449|FG001|Participant Flow|Conversational Counseling|"The conversation group participated in a structured, face-to-face conversation with a trained counselor.~Conversational counseling: Conversational counseling"
11326785|NCT03400449|OG000|Outcome|Video Counseling|"The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.~Video counseling: Video counseling"
11326786|NCT03400449|OG001|Outcome|Conversational Counseling|"The conversation group participated in a structured, face-to-face conversation with a trained counselor.~Conversational counseling: Conversational counseling"
11326787|NCT03400449|OG000|Outcome|Conversational Counseling|"The conversation group participated in a structured, face-to-face conversation with a trained counselor.~Conversational counseling: Conversational counseling"
11326788|NCT03400449|OG001|Outcome|Video Counseling|"The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.~Video counseling: Video counseling"
11326789|NCT03400449|EG000|Reported Event|Video Counseling|"The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.~Video counseling: Video counseling"
11326790|NCT03400449|EG001|Reported Event|Conversational Counseling|"The conversation group participated in a structured, face-to-face conversation with a trained counselor.~Conversational counseling: Conversational counseling"
11326791|NCT03400475|BG000|Baseline|Test Group|"Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Simvastatin: One topical application in peri-implant gingival crevice"
11326792|NCT03400475|BG001|Baseline|Control Group|"Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Placebo: One topical application in peri-implant gingival crevice"
11326793|NCT03400475|BG002|Baseline|Total|Total of all reporting groups
11326794|NCT03400475|FG000|Participant Flow|Test Group|"Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Simvastatin: One topical application in peri-implant gingival crevice"
11326795|NCT03400475|FG001|Participant Flow|Control Group|"Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Placebo: One topical application in peri-implant gingival crevice"
11326796|NCT03400475|OG000|Outcome|Simvastatin Group ( Treatment )|"Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Simvastatin: One topical application in peri-implant gingival crevice"
11326797|NCT03400475|OG001|Outcome|Control Group|"Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Placebo: One topical application in peri-implant gingival crevice"
11326798|NCT03400475|OG000|Outcome|Simvastatin Group ( Treatment)|"Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Simvastatin: One topical application in peri-implant gingival crevice"
11326799|NCT03400475|EG000|Reported Event|Test Group|"Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Simvastatin: One topical application in peri-implant gingival crevice"
11326800|NCT03400475|EG001|Reported Event|Control Group|"Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.~Placebo: One topical application in peri-implant gingival crevice"
11326801|NCT03400579|BG000|Baseline|Remote Ischemic Conditioning|"RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device~autoRIC® device: The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period"
11326802|NCT03400579|FG000|Participant Flow|Remote Ischemic Conditioning|"RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device~autoRIC® device: The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period"
11326803|NCT03400579|OG000|Outcome|Remote Ischemic Conditioning|"RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device~autoRIC® device: The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period"
11326804|NCT03400579|EG000|Reported Event|Remote Ischemic Conditioning|"RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device~autoRIC® device: The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period"
11326805|NCT03400748|BG000|Baseline|RF Ablation|"Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.~RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy."
11326806|NCT03400748|FG000|Participant Flow|RF Ablation|"Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.~RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy."
11326807|NCT03400748|OG000|Outcome|RF Ablation|"Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.~RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy."
11326808|NCT03400748|EG000|Reported Event|RF Ablation|"Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.~RF Ablation: The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy."
11326809|NCT03400787|BG000|Baseline|Sham Control Arm|"Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.~Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.~Latera Implant: Treatment"
11326810|NCT03400787|BG001|Baseline|Latera Treatment Arm|"Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.~Latera Implant: Treatment"
11326811|NCT03400787|BG002|Baseline|Total|Total of all reporting groups
11326812|NCT03400787|FG000|Participant Flow|Sham Control Arm|"Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.~Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.~Latera Implant: Treatment"
11326813|NCT03400787|FG001|Participant Flow|Latera Treatment Arm|"Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.~Latera Implant: Treatment"
11326814|NCT03400787|OG000|Outcome|Sham Control Arm|"Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.~Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.~Latera Implant: Treatment"
11326815|NCT03400787|OG001|Outcome|Latera Treatment Arm|"Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.~Latera Implant: Treatment"
11326816|NCT03400787|EG000|Reported Event|Sham Control Arm|"Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.~Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.~Latera Implant: Treatment"
11326817|NCT03400787|EG001|Reported Event|Latera Treatment Arm|"Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.~Latera Implant: Treatment"
11326818|NCT03400800|BG000|Baseline|Inclisiran|"Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326819|NCT03400800|BG001|Baseline|Placebo|"Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months~Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326820|NCT03400800|BG002|Baseline|Total|Total of all reporting groups
11326821|NCT03400800|FG000|Participant Flow|Inclisiran|"Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326822|NCT03400800|FG001|Participant Flow|Placebo|"Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months~Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326823|NCT03400800|OG000|Outcome|Inclisiran|Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
11326824|NCT03400800|OG001|Outcome|Placebo|Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
11326825|NCT03400800|EG000|Reported Event|Inclisiran|"Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis."
11326826|NCT03400800|EG001|Reported Event|Placebo|"Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months~Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection)."
11326827|NCT03400852|BG000|Baseline|Period 1: MNK-1411|All participants who received any dose of MNK-1411 in Period 1
11326828|NCT03400852|BG001|Baseline|Period 1: Placebo|All patients who received placebo in Period 1
11326829|NCT03400852|BG002|Baseline|Total|Total of all reporting groups
11326830|NCT03400852|FG000|Participant Flow|Period 1: MNK-1411|Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
11326831|NCT03400852|FG001|Participant Flow|Period 1: Placebo|Participants receive placebo at a volume appropriate to body weight during Period 1
11326832|NCT03400852|FG002|Participant Flow|Period 2: MNK-1411|All participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
11326833|NCT03400852|OG000|Outcome|Period 1: MNK-1411|All participants who received any dose of MNK-1411 in Period 1
11326834|NCT03400852|OG001|Outcome|Period 1: Placebo|All patients who received placebo in Period 1
11326835|NCT03400852|OG000|Outcome|Period 2: MNK-1411|All participants who received any dose of MNK-1411 in Period 2
11326836|NCT03400852|EG000|Reported Event|Period 1: MNK-1411|Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
11326837|NCT03400852|EG001|Reported Event|Period 1: Placebo|Participants receive placebo at a volume appropriate to body weight during Period 1
11326838|NCT03400852|EG002|Reported Event|Period 2: MNK-1411|Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
11326855|NCT03401229|BG000|Baseline|Benra 30 mg|Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326856|NCT03401229|BG001|Baseline|Placebo|Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326857|NCT03401229|BG002|Baseline|Total|Total of all reporting groups
11326858|NCT03401229|FG000|Participant Flow|Benra 30 mg|Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326859|NCT03401229|FG001|Participant Flow|Placebo|Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326860|NCT03401229|OG000|Outcome|Benra 30 mg|Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326861|NCT03401229|OG001|Outcome|Placebo|Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326862|NCT03401229|EG000|Reported Event|Benra 30 mg|Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326863|NCT03401229|EG001|Reported Event|Placebo|Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
11326864|NCT03401450|BG000|Baseline|ACB Within True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine~ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block."
11326865|NCT03401450|BG001|Baseline|ACB Proximal to True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine~ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine"
11326866|NCT03401450|BG002|Baseline|Total|Total of all reporting groups
11326867|NCT03401450|FG000|Participant Flow|ACB Within True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine~ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block."
11326868|NCT03401450|FG001|Participant Flow|ACB Proximal to True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine~ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine"
11326869|NCT03401450|OG000|Outcome|ACB Within True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine~ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block."
11326870|NCT03401450|OG001|Outcome|ACB Proximal to True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine~ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine"
11326871|NCT03401450|EG000|Reported Event|ACB Within True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine~ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block."
11326872|NCT03401450|EG001|Reported Event|ACB Proximal to True AC With Bupivacaine|"The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine~ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine"
11326873|NCT03401671|BG000|Baseline|Japanese|Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326874|NCT03401671|BG001|Baseline|Non-Hispanic Caucasians|Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326875|NCT03401671|BG002|Baseline|Total|Total of all reporting groups
11326876|NCT03401671|FG000|Participant Flow|Japanese|Healthy participants of Japanese descent received a single dose of 300 milligrams (mg) lanadelumab subcutaneous (SC) injection in the abdomen.
11326877|NCT03401671|FG001|Participant Flow|Non-Hispanic Caucasians|Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326878|NCT03401671|OG000|Outcome|Japanese|Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326879|NCT03401671|OG001|Outcome|Non-Hispanic Caucasians|Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326880|NCT03401671|EG000|Reported Event|Japanese|Healthy participants of Japanese descent received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326881|NCT03401671|EG001|Reported Event|Non-Hispanic Caucasians|Healthy Non-Hispanic Caucasian participants received a single dose of 300 mg lanadelumab SC injection in the abdomen.
11326882|NCT03402126|BG000|Baseline|TPD RAMWare Injected|"Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.~TPD RAMWare: TPD RAMWare injected into enrolled subject's device."
11326883|NCT03402126|FG000|Participant Flow|TPD RAMWare Download|"Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.~TPD RAMWare: TPD RAMWare injected into enrolled subject's device."
11326884|NCT03402126|OG000|Outcome|TPD RAMWare Download|"Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.~TPD RAMWare: TPD RAMWare injected into enrolled subject's device."
11326885|NCT03402126|EG000|Reported Event|TPD RAMWare Download|"Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.~TPD RAMWare: TPD RAMWare injected into enrolled subject's device."
11326886|NCT03402243|BG000|Baseline|Menthol Ban Only for Cigarettes|"Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes"
11326887|NCT03402243|BG001|Baseline|Menthol Ban for Cigarettes and E-cigarettes|"Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available"
11326888|NCT03402243|BG002|Baseline|No Menthol Ban|"Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available"
11326889|NCT03402243|BG003|Baseline|Total|Total of all reporting groups
11326890|NCT03402243|FG000|Participant Flow|Menthol Ban Only for Cigarettes|"Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes"
11326891|NCT03402243|FG001|Participant Flow|Menthol Ban for Cigarettes and E-cigarettes|"Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available"
11326892|NCT03402243|FG002|Participant Flow|No Menthol Ban|"Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available"
11326893|NCT03402243|OG000|Outcome|Menthol Ban Only for Cigarettes|"Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes"
11326894|NCT03402243|OG001|Outcome|Menthol Ban for Cigarettes and E-cigarettes|"Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available"
11326895|NCT03402243|OG002|Outcome|No Menthol Ban|"Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available"
11326896|NCT03402243|EG000|Reported Event|Menthol Ban Only for Cigarettes|"Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes"
11326897|NCT03402243|EG001|Reported Event|Menthol Ban for Cigarettes and E-cigarettes|"Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge~Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available"
11333713|NCT03519867|BG002|Baseline|3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326898|NCT03402243|EG002|Reported Event|No Menthol Ban|"Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge~No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available"
11326899|NCT03402386|BG000|Baseline|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11326900|NCT03402386|FG000|Participant Flow|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11326901|NCT03402386|OG000|Outcome|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11326902|NCT03402386|EG000|Reported Event|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11326903|NCT03402555|BG000|Baseline|Mother-infant/Toddler Pairs|96 mother-infant/toddler pairs were enrolled in the study
11326904|NCT03402555|FG000|Participant Flow|Mother-infant/Toddler Pairs|96 mother-infant/toddler pairs were enrolled in the study
11326905|NCT03402555|OG000|Outcome|Mother-infant/Toddler Pairs|96 mother-infant/toddler pairs were enrolled in the study
11326906|NCT03402555|EG000|Reported Event|Mother-infant/Toddler Pairs|96 mother-infant/toddler pairs were enrolled in the study
11333714|NCT03519867|BG003|Baseline|4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333715|NCT03519867|BG004|Baseline|5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333716|NCT03519867|BG005|Baseline|6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333717|NCT03519867|BG006|Baseline|7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333718|NCT03519867|BG007|Baseline|8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333719|NCT03519867|BG008|Baseline|9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333720|NCT03519867|BG009|Baseline|10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333721|NCT03519867|BG010|Baseline|Total|Total of all reporting groups
11333722|NCT03519867|FG000|Participant Flow|1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced neuromuscular blockade (NMB) reached 1 to 2 PTCs.
11333723|NCT03519867|FG001|Participant Flow|2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333724|NCT03519867|FG002|Participant Flow|3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
10827905|NCT00112359|BG001|Baseline|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
11333725|NCT03519867|FG003|Participant Flow|4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333726|NCT03519867|FG004|Participant Flow|5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333727|NCT03519867|FG005|Participant Flow|6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333728|NCT03519867|FG006|Participant Flow|7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333729|NCT03519867|FG007|Participant Flow|8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333730|NCT03519867|FG008|Participant Flow|9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
10827906|NCT00112359|BG002|Baseline|Total|Total of all reporting groups
11333731|NCT03519867|FG009|Participant Flow|10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
10827907|NCT00112359|FG000|Participant Flow|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
11326907|NCT03402659|BG000|Baseline|Placebo Arm|Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo
11326908|NCT03402659|BG001|Baseline|Neflamapimod Arm|Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug).
11326909|NCT03402659|BG002|Baseline|Total|Total of all reporting groups
11326910|NCT03402659|FG000|Participant Flow|Placebo Arm|Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo
11326911|NCT03402659|FG001|Participant Flow|Neflamapimod Arm|Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug).
11326912|NCT03402659|OG000|Outcome|Placebo Arm|Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo
11326913|NCT03402659|OG001|Outcome|Neflamapimod Arm|Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug).
11326914|NCT03402659|EG000|Reported Event|Placebo Arm|Arm of trial including the 83 subjects that were randomly assigned (1:1) to take placebo
11326915|NCT03402659|EG001|Reported Event|Neflamapimod Arm|Arm of trial including the 78 subjects that were randomly assigned (1:1) to take neflamapimod (active study drug).
11326916|NCT03402750|BG000|Baseline|Meds to Beds|"Patients receive medication in-hand at discharge from the hospital~Meds to Beds: Medications will be delivered to patient bedside before discharge"
11326917|NCT03402750|BG001|Baseline|Standard Care|"Electronic prescription with patient pickup at the pharmacy~Electronic Prescription: Patient or surrogate can pick up medication from pharmacy"
11326918|NCT03402750|BG002|Baseline|Total|Total of all reporting groups
11326919|NCT03402750|FG000|Participant Flow|Meds to Beds|"Patients receive medication in-hand at discharge from the hospital~Meds to Beds: Medications will be delivered to patient bedside before discharge"
11326920|NCT03402750|FG001|Participant Flow|Standard Care|"Electronic prescription with patient pickup at the pharmacy~Electronic Prescription: Patient or surrogate can pick up medication from pharmacy"
11326921|NCT03402750|OG000|Outcome|Meds to Beds|"Patients receive medication in-hand at discharge from the hospital~Meds to Beds: Medications will be delivered to patient bedside before discharge"
11326922|NCT03402750|OG001|Outcome|Standard Care|"Electronic prescription with patient pickup at the pharmacy~Electronic Prescription: Patient or surrogate can pick up medication from pharmacy"
11326923|NCT03402750|EG000|Reported Event|Meds to Beds|"Patients receive medication in-hand at discharge from the hospital~Meds to Beds: Medications will be delivered to patient bedside before discharge"
11326924|NCT03402750|EG001|Reported Event|Standard Care|"Electronic prescription with patient pickup at the pharmacy~Electronic Prescription: Patient or surrogate can pick up medication from pharmacy"
11326925|NCT03402893|BG000|Baseline|Onexton Gel Application|"Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face~ONEXTON Topical Gel: Onexton gel applied once daily to face"
11326926|NCT03402893|FG000|Participant Flow|Onexton Gel Application|"Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face~ONEXTON Topical Gel: Onexton gel applied once daily to face"
11326927|NCT03402893|OG000|Outcome|Onexton Gel Application|"Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face~ONEXTON Topical Gel: Onexton gel applied once daily to face"
11326928|NCT03402893|OG000|Outcome|Single Arm Onexton Gel Application|"Onexton gel will be supplied to all subjects and applied once daily to the face~ONEXTON Topical Gel: Onexton gel applied once daily to face"
11326929|NCT03402893|EG000|Reported Event|Onexton Gel Application|"Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face~ONEXTON Topical Gel: Onexton gel applied once daily to face"
11326930|NCT03402932|BG000|Baseline|Group1: Younger Control (Auditory Unamplified - Visual)|"This arm is for validating the visual version of the tests with younger individuals with normal hearing.~Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326931|NCT03402932|BG001|Baseline|Group2: Auditory Amplified - Visual|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Visual: The cognitive test was administered visually by using timed computer slides."
11326932|NCT03402932|BG002|Baseline|Group3: Auditory Amplified - Unamplified|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326933|NCT03402932|BG003|Baseline|Group4: Auditory Unamplified - Visual|"Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326934|NCT03402932|BG004|Baseline|Total|Total of all reporting groups
11326935|NCT03402932|FG000|Participant Flow|Group1: Auditory -Visual (Younger Adults w/ Normal Hearing)|A group of younger adults with normal hearing is included to validate the visual version of the tests
11326936|NCT03402932|FG001|Participant Flow|Group2: Amplified-Visual (Older Adults w/ Hearing Loss)|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Visual: The cognitive test was administered visually by using timed computer slides."
11326937|NCT03402932|FG002|Participant Flow|Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11333732|NCT03519867|OG000|Outcome|1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326938|NCT03402932|FG003|Participant Flow|Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)|"Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326939|NCT03402932|OG000|Outcome|Group1: Auditory Unamplified -Visual (Younger Adults)|"Younger adults with normal hearing group was included to validate the visual version of the test.~The auditory administration was unamplified. The visual administration had all test material visually presented."
11326940|NCT03402932|OG001|Outcome|Group2: Amplified-Visual (Older Adults w/ Hearing Loss)|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Visual administration presented all test material visually."
11326941|NCT03402932|OG002|Outcome|Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)|"Auditory amplified: The cognitive test was administered by using customized amplification.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326942|NCT03402932|OG003|Outcome|Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)|"Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326943|NCT03402932|OG000|Outcome|Group1: Younger Control (Auditory Unamplified - Visual)|"This arm is for validating the visual version of the tests with younger individuals with normal hearing.~Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326944|NCT03402932|OG001|Outcome|Group2: Auditory Amplified - Visual|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Visual: The cognitive test was administered visually by using timed computer slides."
11326945|NCT03402932|OG002|Outcome|Group3: Auditory Amplified - Unamplified|"Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326946|NCT03402932|OG003|Outcome|Group4: Auditory Unamplified - Visual|"Visual: The cognitive test was administered visually by using timed computer slides.~Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."
11326947|NCT03402932|EG000|Reported Event|Group1: Younger Auditory Unamplified - Visual|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11326948|NCT03402932|EG001|Reported Event|Group2: Auditory Amplified - Visual|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11326949|NCT03402932|EG002|Reported Event|Group3: Auditory Amplified - Unamplified|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11326950|NCT03402932|EG003|Reported Event|Group4: Auditory Unamplified - Visual|All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
11326951|NCT03403036|BG000|Baseline|Brodalumab|Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
11326952|NCT03403036|FG000|Participant Flow|Brodalumab|Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
11326953|NCT03403036|OG000|Outcome|Brodalumab|Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
11326954|NCT03403036|EG000|Reported Event|Brodalumab|Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
11326955|NCT03403192|BG000|Baseline|EZ-Blocker in the Left Lung|"This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326956|NCT03403192|BG001|Baseline|EZ-Blocker in Right Lung|"This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326957|NCT03403192|BG002|Baseline|Double Lumen Tube (DLT) in Left Lung|"This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11333733|NCT03519867|OG001|Outcome|2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326958|NCT03403192|BG003|Baseline|Double Lumen Tube (DLT) in Right Lung|"This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326959|NCT03403192|BG004|Baseline|Total|Total of all reporting groups
11326960|NCT03403192|FG000|Participant Flow|EZ-Blocker in the Left Lung|"This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326961|NCT03403192|FG001|Participant Flow|EZ-Blocker in Right Lung|"This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326962|NCT03403192|FG002|Participant Flow|DLT in Left Lung|"This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326963|NCT03403192|FG003|Participant Flow|DLT in Right Lung|"This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326964|NCT03403192|OG000|Outcome|EZ-Blocker in the Left Lung|"This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326965|NCT03403192|OG001|Outcome|EZ-Blocker in Right Lung|"This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326966|NCT03403192|OG002|Outcome|DLT in Left Lung|"This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326967|NCT03403192|OG003|Outcome|DLT in Right Lung|"This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326968|NCT03403192|EG000|Reported Event|EZ-Blocker in the Left Lung|"This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11333734|NCT03519867|OG002|Outcome|3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326969|NCT03403192|EG001|Reported Event|EZ-Blocker in Right Lung|"This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.~EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
11326970|NCT03403192|EG002|Reported Event|DLT in Left Lung|"This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326971|NCT03403192|EG003|Reported Event|DLT in Right Lung|"This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.~DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung."
11326972|NCT03403231|BG000|Baseline|Arm 1: Stock Messages Only|"Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326973|NCT03403231|BG001|Baseline|Arm 2: Urgency Frame Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326974|NCT03403231|BG002|Baseline|Arm 3: Social Norm Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326975|NCT03403231|BG003|Baseline|Arm 4: Urgency Frame and Social Norm Strategies|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326976|NCT03403231|BG004|Baseline|Arm 5: Implementation Intentions and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326977|NCT03403231|BG005|Baseline|Arm 6: Implementation Intentions and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326978|NCT03403231|BG006|Baseline|Arm 7: Implementation Intentions, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326979|NCT03403231|BG007|Baseline|Arm 8: Implementation Intentions|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326980|NCT03403231|BG008|Baseline|Arm 9: Preference Checklists and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326981|NCT03403231|BG009|Baseline|Arm 10: Preference Checklists and Social Norms|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11333735|NCT03519867|OG003|Outcome|4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11326982|NCT03403231|BG010|Baseline|Arm 11: Preference Checklists, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326983|NCT03403231|BG011|Baseline|Arm 12: Preference Checklists|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326984|NCT03403231|BG012|Baseline|Arm 13: Tailored Aspirations and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326985|NCT03403231|BG013|Baseline|Arm 14: Tailored Aspirations and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326986|NCT03403231|BG014|Baseline|Arm 15: Tailored Aspirations, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326987|NCT03403231|BG015|Baseline|Arm 16: Tailored Aspirations|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326988|NCT03403231|BG016|Baseline|Total|Total of all reporting groups
11326989|NCT03403231|FG000|Participant Flow|Arm 1: Stock Messages Only|"Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326990|NCT03403231|FG001|Participant Flow|Arm 2: Urgency Frame Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326991|NCT03403231|FG002|Participant Flow|Arm 3: Social Norm Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326992|NCT03403231|FG003|Participant Flow|Arm 4: Urgency Frame and Social Norm Strategies|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326993|NCT03403231|FG004|Participant Flow|Arm 5: Implementation Intentions and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326994|NCT03403231|FG005|Participant Flow|Arm 6: Implementation Intentions and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326995|NCT03403231|FG006|Participant Flow|Arm 7: Implementation Intentions, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326996|NCT03403231|FG007|Participant Flow|Arm 8: Implementation Intentions|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326997|NCT03403231|FG008|Participant Flow|Arm 9: Preference Checklists and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326998|NCT03403231|FG009|Participant Flow|Arm 10: Preference Checklists and Social Norms|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11326999|NCT03403231|FG010|Participant Flow|Arm 11: Preference Checklists, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327000|NCT03403231|FG011|Participant Flow|Arm 12: Preference Checklists|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327001|NCT03403231|FG012|Participant Flow|Arm 13: Tailored Aspirations and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327002|NCT03403231|FG013|Participant Flow|Arm 14: Tailored Aspirations and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327003|NCT03403231|FG014|Participant Flow|Arm 15: Tailored Aspirations, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327004|NCT03403231|FG015|Participant Flow|Arm 16: Tailored Aspirations|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327005|NCT03403231|OG000|Outcome|Arm 1: Stock Messages Only|"Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327006|NCT03403231|OG001|Outcome|Arm 2: Urgency Frame Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327007|NCT03403231|OG002|Outcome|Arm 3: Social Norm Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327008|NCT03403231|OG003|Outcome|Arm 4: Urgency Frame and Social Norm Strategies|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327009|NCT03403231|OG004|Outcome|Arm 5: Implementation Intentions and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327010|NCT03403231|OG005|Outcome|Arm 6: Implementation Intentions and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11333736|NCT03519867|OG004|Outcome|5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327011|NCT03403231|OG006|Outcome|Arm 7: Implementation Intentions, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327012|NCT03403231|OG007|Outcome|Arm 8: Implementation Intentions|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327013|NCT03403231|OG008|Outcome|Arm 9: Preference Checklists and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327014|NCT03403231|OG009|Outcome|Arm 10: Preference Checklists and Social Norms|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327015|NCT03403231|OG010|Outcome|Arm 11: Preference Checklists, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327016|NCT03403231|OG011|Outcome|Arm 12: Preference Checklists|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327017|NCT03403231|OG012|Outcome|Arm 13: Tailored Aspirations and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327018|NCT03403231|OG013|Outcome|Arm 14: Tailored Aspirations and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327019|NCT03403231|OG014|Outcome|Arm 15: Tailored Aspirations, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327020|NCT03403231|OG015|Outcome|Arm 16: Tailored Aspirations|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327021|NCT03403231|EG000|Reported Event|Arm 1: Stock Messages Only|"Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327022|NCT03403231|EG001|Reported Event|Arm 2: Urgency Frame Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327023|NCT03403231|EG002|Reported Event|Arm 3: Social Norm Message Strategy|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327024|NCT03403231|EG003|Reported Event|Arm 4: Urgency Frame and Social Norm Strategies|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11333737|NCT03519867|OG005|Outcome|6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327025|NCT03403231|EG004|Reported Event|Arm 5: Implementation Intentions and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327026|NCT03403231|EG005|Reported Event|Arm 6: Implementation Intentions and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327027|NCT03403231|EG006|Reported Event|Arm 7: Implementation Intentions, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327028|NCT03403231|EG007|Reported Event|Arm 8: Implementation Intentions|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327029|NCT03403231|EG008|Reported Event|Arm 9: Preference Checklists and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327030|NCT03403231|EG009|Reported Event|Arm 10: Preference Checklists and Social Norms|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327031|NCT03403231|EG010|Reported Event|Arm 11: Preference Checklists, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327032|NCT03403231|EG011|Reported Event|Arm 12: Preference Checklists|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327033|NCT03403231|EG012|Reported Event|Arm 13: Tailored Aspirations and Urgency Frame|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
10827908|NCT00112359|FG001|Participant Flow|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
11327034|NCT03403231|EG013|Reported Event|Arm 14: Tailored Aspirations and Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327035|NCT03403231|EG014|Reported Event|Arm 15: Tailored Aspirations, Urgency Frame & Social Norm|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327036|NCT03403231|EG015|Reported Event|Arm 16: Tailored Aspirations|"Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.~INVENT Secure Messaging Intervention: We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive."
11327037|NCT03403374|BG000|Baseline|Evolocumab|Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
11327038|NCT03403374|FG000|Participant Flow|Evolocumab|Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
11327039|NCT03403374|OG000|Outcome|Evolocumab|Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
10827909|NCT00112359|OG000|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
11327040|NCT03403374|EG000|Reported Event|Evolocumab|Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
11327041|NCT03403400|BG000|Baseline|VRWP Group|"Vestibular Rehabilitation plus Walking with Pedometer Groupd~VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily."
11327042|NCT03403400|BG001|Baseline|VRW Group|"Vestibular Rehabilitation plus Walking without Pedometer Group~VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program."
11327043|NCT03403400|BG002|Baseline|VR Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327044|NCT03403400|BG003|Baseline|Total|Total of all reporting groups
11327045|NCT03403400|FG000|Participant Flow|VRWP Group|"Vestibular Rehabilitation plus Walking with Pedometer Groupd~VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily."
11327046|NCT03403400|FG001|Participant Flow|VRW Group|"Vestibular Rehabilitation plus Walking without Pedometer Group~VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program."
11327047|NCT03403400|FG002|Participant Flow|VR Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327048|NCT03403400|OG000|Outcome|Control (VR) Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327049|NCT03403400|OG001|Outcome|VRWP (Vestibular Rehabilitation With Walking With Pedometer)|Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
11327050|NCT03403400|OG002|Outcome|VRW (Vestibular Rehabilitation Walking Without a Pedometer)|Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
11327051|NCT03403400|OG003|Outcome|Prescribed Walking Group|VRWP and VRW data were combined into a group representing prescribed walking.
11327052|NCT03403400|OG001|Outcome|Vestibular Rehabilitation With Walking With Pedometer (VRWP)|The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer groupVestibular Rehabilitation with Walking without a Pedometer.
11327053|NCT03403400|OG002|Outcome|Vestibular Rehabilitation Walking Without a Pedometer (VRW)|The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
11327054|NCT03403400|OG003|Outcome|Prescribed Walking (VRWP +VRW) Group|The Prescribed Walking group is composed of 4 subjects walking with pedometer (VRWP) and 6 subjects walking without pedometer (VRW).
11327055|NCT03403400|OG001|Outcome|Vestibular Rehabilitation With Walking With Pedometer|The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer groupVestibular Rehabilitation with Walking without a Pedometer.
11327056|NCT03403400|OG002|Outcome|Vestibular Rehabilitation Walking Without Pedometer (VRW)|The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
11327057|NCT03403400|OG003|Outcome|Prescribed Walking (VRWP +VRW) Group|The walking group is composed of the VRWP (Vestibular Rehabilitation with Walking with Pedometer) and VRW (Vestibular Rehabilitation with Walking without Pedometer
11327058|NCT03403400|OG003|Outcome|Prescribed Walking Group (VRWP+VRW)|The walking group is composed of the VRWP (Vestibular Rehabilitation with Walking with Pedometer) and VRW (Vestibular Rehabilitation with Walking without Pedometer)
11327059|NCT03403400|OG000|Outcome|VR Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327060|NCT03403400|OG002|Outcome|Vestibular Rehabilitation Walking With no Pedometer (VRW)|The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
11327061|NCT03403400|OG003|Outcome|Prescribed Walking (VRWP +VRW) Group|The Prescribed walking group is composed of the VRWP (Vestibular Rehabilitation with Walking with Pedometer) and VRW (Vestibular Rehabilitation with Walking without Pedometer
11327062|NCT03403400|OG001|Outcome|Vestibular Rehabilitation With Walking With Pedometer (VRWP)|The VRWP group (N=6) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer groupVestibular Rehabilitation with Walking without a Pedometer.
11333738|NCT03519867|OG006|Outcome|7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327063|NCT03403400|OG000|Outcome|VRWP Group|"Vestibular Rehabilitation plus Walking with Pedometer Groupd~VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily."
11327064|NCT03403400|OG001|Outcome|VRW Group|"Vestibular Rehabilitation plus Walking without Pedometer Group~VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program."
11327065|NCT03403400|OG002|Outcome|VR Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327066|NCT03403400|EG000|Reported Event|VRWP Group|"Vestibular Rehabilitation plus Walking with Pedometer Groupd~VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily."
11327067|NCT03403400|EG001|Reported Event|VRW Group|"Vestibular Rehabilitation plus Walking without Pedometer Group~VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program."
11327068|NCT03403400|EG002|Reported Event|VR Group|Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
11327069|NCT03403413|BG000|Baseline|Muscle Vibration|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group and gait training without muscle vibration during walking in control group and repeat gait assessment after gait training."
11327070|NCT03403413|FG000|Participant Flow|Muscle Vibration|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~Muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities and repeat gait assessment after gait training."
11327071|NCT03403413|OG000|Outcome|Subject A|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~Muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities and repeat gait assessment after gait training."
11327072|NCT03403413|OG001|Outcome|Subject B|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~Muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities and repeat gait assessment after gait training."
11327073|NCT03403413|OG002|Outcome|Subject C|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~Muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities and repeat gait assessment after gait training."
11327074|NCT03403413|EG000|Reported Event|Feasibility|"Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.~Muscle vibration during walking: Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities and repeat gait assessment after gait training."
11327075|NCT03403426|BG000|Baseline|Wingman Crossing Catheter|"Use of the device to support CTO crossing~Wingman Crossing Catheter: Endovascular CTO crossing"
11327076|NCT03403426|FG000|Participant Flow|Wingman Crossing Catheter|"Use of the device to support CTO crossing~Wingman Crossing Catheter: Endovascular CTO crossing"
11327077|NCT03403426|OG000|Outcome|Wingman Crossing Catheter|"Use of the device to support CTO crossing~Wingman Crossing Catheter: Endovascular CTO crossing"
11327078|NCT03403426|EG000|Reported Event|Wingman Crossing Catheter|"Use of the device to support CTO crossing~Wingman Crossing Catheter: Endovascular CTO crossing"
11327079|NCT03403491|BG000|Baseline|All Patients|All patients who started patientMpower observation period
11333739|NCT03519867|OG007|Outcome|8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327080|NCT03403491|FG000|Participant Flow|Sequence 1|"Usual care for 2 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks.~patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms~sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms"
11327081|NCT03403491|FG001|Participant Flow|Sequence 2|"Usual care for 2 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks.~patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms~sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms"
11327082|NCT03403491|OG000|Outcome|All Patients|All patients who started patientMpower observation period
11327083|NCT03403491|OG000|Outcome|Sham|sham observation period
11327084|NCT03403491|OG001|Outcome|patientMpower|patientMpower observation period
11327085|NCT03403491|EG000|Reported Event|Sham Observation Period|All patients who started sham observation period
11327086|NCT03403491|EG001|Reported Event|patientMpower Observation Period|All patient who started patientMpower observation period
11327087|NCT03403504|BG000|Baseline|OXYCONTIN 10 Mg-OTR 10 mg|the treatment sequence is OXYCONTIN 10 mg dose first and then OTR 10 mg dose
11327088|NCT03403504|BG001|Baseline|OTR 10 Mg-OXYCONTIN 10 mg|the treatment sequence is OTR 10 mg dose first and then OXYCONTIN 10 mg dose
11327089|NCT03403504|BG002|Baseline|Total|Total of all reporting groups
11327090|NCT03403504|FG000|Participant Flow|OXYCONTIN 10 mg - OTR 10 mg|the treatment sequence is OXYCONTIN 10 mg dose first and then OTR 10 mg dose in fasted state
11327091|NCT03403504|FG001|Participant Flow|OTR 10 Mg-OXYCONTIN 10 mg|the treatment sequence is OTR 10 mg dose first and then OXYCONTIN 10 mg dose in fasted state
11327092|NCT03403504|OG000|Outcome|Cmax of OTR 10 mg|the treatment group with OTR 10 mg
11327093|NCT03403504|OG001|Outcome|Cmax of OXYCONTIN 10 mg|the treatment group with OXYCONTIN 10 mg
11327094|NCT03403504|OG000|Outcome|AUCt of OTR Tablet 10 mg|OTR tablet 10 mg
11327095|NCT03403504|OG001|Outcome|AUCt of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327096|NCT03403504|OG000|Outcome|AUCINF of OTR Tablet 10 mg|OTR tablet 10 mg
11327097|NCT03403504|OG001|Outcome|AUCINF of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327098|NCT03403504|OG000|Outcome|Adverse Events of OTR Tablet 10 mg|OTR tablet 10 mg
11327099|NCT03403504|OG001|Outcome|Adverse Events of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327100|NCT03403504|OG000|Outcome|Vital Signs of OTR Tablet 10 mg|OTR tablet 10 mg
11327101|NCT03403504|OG001|Outcome|Vital Signs of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327102|NCT03403504|OG000|Outcome|ECG of OTR Tablet 10 mg|OTR tablet 10 mg and OXYCONTIN tablet 10 mg
11327103|NCT03403504|OG001|Outcome|ECG of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327104|NCT03403504|OG000|Outcome|Clinical Laboratory Data of OTR Tablet 10 mg|OTR tablet 10 mg
11327105|NCT03403504|OG001|Outcome|Clinical Laboratory Data of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327106|NCT03403504|OG000|Outcome|Physical Examinations of OTR Tablet 10 mg|OTR tablet 10 mg
11327107|NCT03403504|OG001|Outcome|Physical Examinations of OXYCONTIN Tablet 10 mg|OXYCONTIN tablet 10 mg
11327108|NCT03403504|EG000|Reported Event|OTR 10 mg|the treatment group with OTR 10 mg
11327109|NCT03403504|EG001|Reported Event|OXYCONTIN 10 mg|the treatment group with OXYCONTIN 10 mg
11327110|NCT03403517|BG000|Baseline|Methylprednisolone|"10 mg/kg, single preoperative infusion~Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery"
11327111|NCT03403517|BG001|Baseline|Dexamethasone|"8 mg dexamethasone, single preoperative infusion~Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery"
11327112|NCT03403517|BG002|Baseline|Total|Total of all reporting groups
11327113|NCT03403517|FG000|Participant Flow|Methylprednisolone|"10 mg/kg, single preoperative infusion~Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery"
11327114|NCT03403517|FG001|Participant Flow|Dexamethasone|"8 mg dexamethasone, single preoperative infusion~Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery"
11327115|NCT03403517|OG000|Outcome|Methylprednisolone|"10 mg/kg, single preoperative infusion~Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery"
11327116|NCT03403517|OG001|Outcome|Dexamethasone|"8 mg dexamethasone, single preoperative infusion~Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery"
11327117|NCT03403517|EG000|Reported Event|Methylprednisolone|"10 mg/kg, single preoperative infusion~Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery"
11327118|NCT03403517|EG001|Reported Event|Dexamethasone|"8 mg dexamethasone, single preoperative infusion~Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery"
11333740|NCT03519867|OG008|Outcome|9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327119|NCT03403712|BG000|Baseline|Test Group|"intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~fosnetupitant/ palonosetron: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327120|NCT03403712|BG001|Baseline|Control Group|"oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~netupitant/palonosetron: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327121|NCT03403712|BG002|Baseline|Total|Total of all reporting groups
11327122|NCT03403712|FG000|Participant Flow|Test Group|"intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~fosnetupitant/ palonosetron: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327123|NCT03403712|FG001|Participant Flow|Control Group|"oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~netupitant/palonosetron: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327124|NCT03403712|OG000|Outcome|Test Group|"intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~fosnetupitant/ palonosetron: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327125|NCT03403712|OG001|Outcome|Control Group|"oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~netupitant/palonosetron: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327126|NCT03403712|EG000|Reported Event|Test Group|"intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~fosnetupitant/ palonosetron: intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327127|NCT03403712|EG001|Reported Event|Control Group|"oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.~Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)~netupitant/palonosetron: oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination~dexamethasone: Oral dexamethasone (12 mg)"
11327128|NCT03403725|BG000|Baseline|Cohort1 0.05mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 0.05mg/kg of MEN1309.
11327129|NCT03403725|BG001|Baseline|Cohort2 0.10mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 0.10mg/kg of MEN1309.
11327130|NCT03403725|BG002|Baseline|Cohort3 0.20mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 0.20mg/kg of MEN1309.
11327131|NCT03403725|BG003|Baseline|Cohort4 0.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 0.40mg/kg of MEN1309.
11327132|NCT03403725|BG004|Baseline|Cohort5 0.80mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 0.80mg/kg of MEN1309.
11327133|NCT03403725|BG005|Baseline|Cohort6 1.60mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 1.60mg/kg of MEN1309.
11327134|NCT03403725|BG006|Baseline|Cohort7 2.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.
11327135|NCT03403725|BG007|Baseline|Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF|Patients with CD205-positive advanced solid tumors, who recieved 3.36mg/kg of MEN1309.
11327136|NCT03403725|BG008|Baseline|Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.
11327137|NCT03403725|BG009|Baseline|Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved 2.00mg/kg of MEN1309.
11327138|NCT03403725|BG010|Baseline|Cohort5 0.80mg/kg STEP 2 NHL|Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
11327139|NCT03403725|BG011|Baseline|Total|Total of all reporting groups
11327140|NCT03403725|FG000|Participant Flow|Cohort1 0.05mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
11327141|NCT03403725|FG001|Participant Flow|Cohort2 0.10mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
11327142|NCT03403725|FG002|Participant Flow|Cohort3 0.20mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
11327143|NCT03403725|FG003|Participant Flow|Cohort4 0.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
11327144|NCT03403725|FG004|Participant Flow|Cohort5 0.80mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.
11327145|NCT03403725|FG005|Participant Flow|Cohort6 1.60mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.
11327146|NCT03403725|FG006|Participant Flow|Cohort7 2.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
11327147|NCT03403725|FG007|Participant Flow|Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.
11327148|NCT03403725|FG008|Participant Flow|Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
11327149|NCT03403725|FG009|Participant Flow|Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.
11327150|NCT03403725|FG010|Participant Flow|Cohort5 0.80mg/kg STEP 2 NHL|Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
11327151|NCT03403725|OG000|Outcome|All Doses STEP 1-Solid Tumors|All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.
11327152|NCT03403725|OG000|Outcome|Cohort1 0.05mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
11327153|NCT03403725|OG001|Outcome|Cohort2 0.10mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
11327154|NCT03403725|OG002|Outcome|Cohort3 0.20mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
11327155|NCT03403725|OG003|Outcome|Cohort4 0.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
11327156|NCT03403725|OG004|Outcome|Cohort5 0.80mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.
11327157|NCT03403725|OG005|Outcome|Cohort6 1.60mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.
11327158|NCT03403725|OG006|Outcome|Cohort7 2.40mg/kg STEP 1 Solid Tumors|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
11327159|NCT03403725|OG007|Outcome|Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.
11327160|NCT03403725|OG008|Outcome|Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
11327161|NCT03403725|OG009|Outcome|Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.
11327162|NCT03403725|OG010|Outcome|Cohort5 0.80mg/kg STEP 2 NHL|Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
11327163|NCT03403725|OG000|Outcome|STEP1 Solid Tumor All Doses + STEP 2 NHL|All Patients with CD205-positive advanced solid tumors inlcuded in STEP1 and all NHL patients included in STEP 2.
11327164|NCT03403725|EG000|Reported Event|Cohort1 0.05mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 0.05 mg/kg of MEN1309.
11327165|NCT03403725|EG001|Reported Event|Cohort2 0.10mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 0.10 mg/kg of MEN1309.
11327166|NCT03403725|EG002|Reported Event|Cohort3 0.20mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 0.20 mg/kg of MEN1309.
11327167|NCT03403725|EG003|Reported Event|Cohort4 0.40mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 0.40 mg/kg of MEN1309.
11327168|NCT03403725|EG004|Reported Event|Cohort5 0.80mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 0.80 mg/kg of MEN1309.
11327169|NCT03403725|EG005|Reported Event|Cohort6 1.60mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 1.60 mg/kg of MEN1309.
11327170|NCT03403725|EG006|Reported Event|Cohort7 2.40mg/kg STEP 1 Solid Tumors|Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.
11327171|NCT03403725|EG007|Reported Event|Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF|Patients with CD205-advanced Solid Tumor, who recieved 3.36 mg/kg of MEN1309.
11327172|NCT03403725|EG008|Reported Event|Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.
11327173|NCT03403725|EG009|Reported Event|Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF|Patients with CD205-advanced Solid Tumor, who recieved 2.00 mg/kg of MEN1309.
11327174|NCT03403725|EG010|Reported Event|Cohort5 0.80mg/kg STEP 2 NHL|Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
11327175|NCT03403751|BG000|Baseline|Reltecimod 0.5 mg/kg|Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
11327176|NCT03403751|BG001|Baseline|Placebo|Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
11327177|NCT03403751|BG002|Baseline|Total|Total of all reporting groups
11327178|NCT03403751|FG000|Participant Flow|Reltecimod 0.5 mg/kg|Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
11327179|NCT03403751|FG001|Participant Flow|Placebo|Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
11327180|NCT03403751|OG000|Outcome|Reltecimod 0.5 mg/kg|Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
11327181|NCT03403751|OG001|Outcome|Placebo|Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
11327182|NCT03403751|OG000|Outcome|Day 14 mSOFA <= 1|mSOFA total score on Day 14 of 0 or 1
11327183|NCT03403751|OG001|Outcome|Day 14 mSOFA >= 2|mSOFA total score on Day 14 of at least 2
11327184|NCT03403751|EG000|Reported Event|Reltecimod 0.5 mg/kg|Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
11327185|NCT03403751|EG001|Reported Event|Placebo|Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
11327186|NCT03404167|BG000|Baseline|Zoliflodacin|"4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting~AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent"
11327187|NCT03404167|FG000|Participant Flow|Zoliflodacin|"4 g (2 sachets of 2 g) of zoliflodacin orally in the morning of Day 1 after 8 hours of fasting~AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent"
11327188|NCT03404167|OG000|Outcome|Zoliflodacin|"4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting~AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent"
11327189|NCT03404167|OG000|Outcome|Zoliflodacin|4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
11327190|NCT03404167|OG000|Outcome|Zoliflodacin|"4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting.~AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent"
11327191|NCT03404167|EG000|Reported Event|Zoliflodacin|"4 g (2 sachets of 2 g) of zoliflodacin orally in the morning of Day 1 after 8 hours of fasting, n=8~AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent"
11327192|NCT03404206|BG000|Baseline|Naproxen Sodium (Aleve, BAY117031)|Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
11327193|NCT03404206|BG001|Baseline|Ibuprofen (Advil)|Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
11327194|NCT03404206|BG002|Baseline|Placebo|Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
11327195|NCT03404206|BG003|Baseline|Total|Total of all reporting groups
11327196|NCT03404206|FG000|Participant Flow|Naproxen Sodium (Aleve, BAY117031)|Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
11327197|NCT03404206|FG001|Participant Flow|Ibuprofen (Advil)|Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
11327198|NCT03404206|FG002|Participant Flow|Placebo|Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
11327199|NCT03404206|OG000|Outcome|Naproxen Sodium (Aleve, BAY117031)|Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
11327200|NCT03404206|OG001|Outcome|Ibuprofen (Advil)|Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
11327201|NCT03404206|OG002|Outcome|Placebo|Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
11327202|NCT03404206|EG000|Reported Event|Naproxen Sodium (Aleve, BAY117031)|Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
11327203|NCT03404206|EG001|Reported Event|Placebo|Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization
11327204|NCT03404206|EG002|Reported Event|Ibuprofen (Advil)|Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
11327205|NCT03404219|BG000|Baseline|Intervention Group|All participants were assigned to this group and received the intervention.
11327206|NCT03404219|FG000|Participant Flow|Intervention Group|All participants were assigned to this group and received the intervention.
11327207|NCT03404219|OG000|Outcome|Intervention Group|All participants were assigned to this group and received the intervention.
11327208|NCT03404219|OG000|Outcome|Intervention|"Mobile intervention (i.e., Ecological momentary intervention [EMI]) addressing social motivation and social skills. Twice daily notifications sent to deliver EMI content. Social goal reminders and steps provided to support goal attainment. Social Skills Training content delivered via brief video clips.~Motivation and Skills Support (MASS): Mobile phone-based application to support social skills and social motivation"
11327209|NCT03404219|EG000|Reported Event|Intervention Group|All participants were assigned to this group and received the intervention.
11327210|NCT03404375|BG000|Baseline|Cases|Cases defined as delta hemoglobin in the upper quartile
11327211|NCT03404375|BG001|Baseline|Control|Controls defined as delta hemoglobin in the lower quartile
11327212|NCT03404375|BG002|Baseline|Total|Total of all reporting groups
11327213|NCT03404375|FG000|Participant Flow|Cases|Cases defined as delta hemoglobin in the upper quartile
11327214|NCT03404375|FG001|Participant Flow|Control|Controls defined as delta hemoglobin in the lower quartile
11327215|NCT03404375|OG000|Outcome|Cases|Cases defined as delta hemoglobin in the upper quartile
11327216|NCT03404375|OG001|Outcome|Control|Controls defined as delta hemoglobin in the lower quartile
11327217|NCT03404375|EG000|Reported Event|Cases|Cases defined as delta hemoglobin in the upper quartile
11327218|NCT03404375|EG001|Reported Event|Control|Controls defined as delta hemoglobin in the lower quartile
11327219|NCT03404401|BG000|Baseline|BLI4700 Bowel Preparation|BLI4700: Oral bowel preparation
11327220|NCT03404401|BG001|Baseline|FDA Approved Bowel Preparation|Polyethylene glycol bowel preparation: Oral bowel preparation
11327221|NCT03404401|BG002|Baseline|Total|Total of all reporting groups
11327222|NCT03404401|FG000|Participant Flow|BLI4700 Bowel Preparation|BLI4700: Oral bowel preparation
11327223|NCT03404401|FG001|Participant Flow|FDA Approved Bowel Preparation|Polyethylene glycol bowel preparation: Oral bowel preparation
11327224|NCT03404401|OG000|Outcome|BLI4700 Bowel Preparation|BLI4700: Oral bowel preparation
11327225|NCT03404401|OG001|Outcome|FDA Approved Bowel Preparation|Polyethylene glycol bowel preparation: Oral bowel preparation
11327226|NCT03404401|EG000|Reported Event|BLI4700 Bowel Preparation|BLI4700: Oral bowel preparation
11327227|NCT03404401|EG001|Reported Event|FDA Approved Bowel Preparation|Polyethylene glycol bowel preparation: Oral bowel preparation
11327228|NCT03404609|BG000|Baseline|rTMS|"Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.~MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition."
11327229|NCT03404609|FG000|Participant Flow|rTMS|"Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.~MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition."
11327230|NCT03404609|OG000|Outcome|rTMS|"Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.~MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition."
11327231|NCT03404609|EG000|Reported Event|rTMS|"Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.~MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition."
11327232|NCT03404648|BG000|Baseline|High Risk Prostate Cancer Patients|"Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).~C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.~Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.~PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer."
11327233|NCT03404648|FG000|Participant Flow|High Risk Prostate Cancer Patients|"Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).~C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.~Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.~PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer."
11327234|NCT03404648|OG000|Outcome|High Risk Prostate Cancer Patients|"Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).~C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.~Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.~PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer."
11327235|NCT03404648|EG000|Reported Event|High Risk Prostate Cancer Patients|"Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).~C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.~Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.~PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer."
11327236|NCT03404674|BG000|Baseline|Group A1: CssBA 5 µg|Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
11327237|NCT03404674|BG001|Baseline|Group A2: DmLT 100 ng|Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
11327238|NCT03404674|BG002|Baseline|Group B: CssBA 5 µg + DmLT 100 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
11327239|NCT03404674|BG003|Baseline|Group C: CssBA 5 µg + DmLT 500 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327240|NCT03404674|BG004|Baseline|Group D: CssBA 15 µg + DmLT 500 ng|Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327241|NCT03404674|BG005|Baseline|Group E: CssBA 45 µg + DmLT 500 ng|Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327242|NCT03404674|BG006|Baseline|Total|Total of all reporting groups
11327243|NCT03404674|FG000|Participant Flow|Group A1: CssBA 5 µg|Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
11327244|NCT03404674|FG001|Participant Flow|Group A2: DmLT 100 ng|Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
11327245|NCT03404674|FG002|Participant Flow|Group B: CssBA 5 µg + DmLT 100 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
11327246|NCT03404674|FG003|Participant Flow|Group C: CssBA 5 µg + DmLT 500 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327247|NCT03404674|FG004|Participant Flow|Group D: CssBA 15 µg + DmLT 500 ng|Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327248|NCT03404674|FG005|Participant Flow|Group E: CssBA 45 µg + DmLT 500 ng|Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327249|NCT03404674|OG000|Outcome|Group A1: CssBA 5 µg|Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
11327250|NCT03404674|OG001|Outcome|Group A2: DmLT 100 ng|Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
11327251|NCT03404674|OG002|Outcome|Group B: CssBA 5 µg + DmLT 100 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
11327252|NCT03404674|OG003|Outcome|Group C: CssBA 5 µg + DmLT 500 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327253|NCT03404674|OG004|Outcome|Group D: CssBA 15 µg + DmLT 500 ng|Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327254|NCT03404674|OG005|Outcome|Group E: CssBA 45 µg + DmLT 500 ng|Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327255|NCT03404674|OG001|Outcome|Group A2: DmLT 100 ng|Participants received 3 intramuscular injections of 100 ng DmLT on days 1, 22, and 43.
11327256|NCT03404674|EG000|Reported Event|Group A1: CssBA 5 µg|Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
11327257|NCT03404674|EG001|Reported Event|Group A2: DmLT 100 ng|Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
11327258|NCT03404674|EG002|Reported Event|Group B: CssBA 5 µg + DmLT 100 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
11327259|NCT03404674|EG003|Reported Event|Group C: CssBA 5 µg + DmLT 500 ng|Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327260|NCT03404674|EG004|Reported Event|Group D: CssBA 15 µg + DmLT 500 ng|Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327261|NCT03404674|EG005|Reported Event|Group E: CssBA 45 µg + DmLT 500 ng|Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
11327262|NCT03404843|BG000|Baseline|Fasudil, Then Saline|Participants were randomized to receive a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release.
11327263|NCT03404843|BG001|Baseline|Saline, Then Fasudil|Participants were randomized to receive a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release.
11327264|NCT03404843|BG002|Baseline|Total|Total of all reporting groups
11327265|NCT03404843|FG000|Participant Flow|Fasudil, Then Saline|Participants were randomized to receive a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release.
11327266|NCT03404843|FG001|Participant Flow|Saline, Then Fasudil|Participants were randomized to receive a single 100 mL intravenous infusion of saline (placebo) in 60 minutes prior to measurements of vascular function and ATP release. After a washout period of at least 5 days, participants received a single 100 mL intravenous infusion of 60 mg fasudil hydrocholoride + saline in 60 minutes prior to measurements of vascular function and ATP release.
11327267|NCT03404843|OG000|Outcome|Young Saline|Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
11327268|NCT03404843|OG001|Outcome|Young Fasudil|Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
11327269|NCT03404843|OG002|Outcome|Older Saline|Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
11327270|NCT03404843|OG003|Outcome|Older Fasudil|Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
11327271|NCT03404843|EG000|Reported Event|Young Saline|Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
11327272|NCT03404843|EG001|Reported Event|Young Fasudil|Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
11327273|NCT03404843|EG002|Reported Event|Older Saline|Participants received a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to outcome measurements
11327274|NCT03404843|EG003|Reported Event|Older Fasudil|Participants received a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to outcome measurements
11327275|NCT03405259|BG000|Baseline|Super Seal® Desensitizer|"Professionally Applied~Super Seal® Desensitizer: Single dose professional application."
11327276|NCT03405259|BG001|Baseline|Acclean® Fluoride Varnish|"Professionally Applied~Acclean® Fluoride Varnish: Single dose professional application."
11327277|NCT03405259|BG002|Baseline|Total|Total of all reporting groups
11327278|NCT03405259|FG000|Participant Flow|Super Seal® Desensitizer|"Professionally Applied~Super Seal® Desensitizer: Single dose professional application."
11327279|NCT03405259|FG001|Participant Flow|Acclean® Fluoride Varnish|"Professionally Applied~Acclean® Fluoride Varnish: Single dose professional application."
11327280|NCT03405259|OG000|Outcome|Super Seal® Desensitizer|"Professionally Applied~Super Seal® Desensitizer: Single dose professional application."
11327281|NCT03405259|OG001|Outcome|Acclean® Fluoride Varnish|"Professionally Applied~Acclean® Fluoride Varnish: Single dose professional application."
11327282|NCT03405259|EG000|Reported Event|Super Seal® Desensitizer|"Professionally Applied~Super Seal® Desensitizer: Single dose professional application."
11327283|NCT03405259|EG001|Reported Event|Acclean® Fluoride Varnish|"Professionally Applied~Acclean® Fluoride Varnish: Single dose professional application."
11327284|NCT03405363|BG000|Baseline|Olodaterol|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327285|NCT03405363|BG001|Baseline|Other Long-acting beta2-agonist (LABAs)|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327286|NCT03405363|BG002|Baseline|Total|Total of all reporting groups
11327287|NCT03405363|FG000|Participant Flow|Olodaterol|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327288|NCT03405363|FG001|Participant Flow|Other Long-acting beta2-agonist (LABAs)|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327289|NCT03405363|OG000|Outcome|Olodaterol|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327290|NCT03405363|OG001|Outcome|Other Long-acting beta2-agonist (LABAs)|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327291|NCT03405363|EG000|Reported Event|Olodaterol|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327292|NCT03405363|EG001|Reported Event|Other Long-acting beta2-agonist (LABAs)|"Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut).~Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year."
11327293|NCT03405818|BG000|Baseline|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
11327294|NCT03405818|FG000|Participant Flow|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
11327295|NCT03405818|OG000|Outcome|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
11327296|NCT03405818|EG000|Reported Event|Kerydin|Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug.
11327297|NCT03405935|BG000|Baseline|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
11327298|NCT03405935|FG000|Participant Flow|B/F/TAF|Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily, without regard to food for at least 96 weeks.
11327299|NCT03405935|OG000|Outcome|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
11327300|NCT03405935|EG000|Reported Event|B/F/TAF|B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
11327301|NCT03406260|BG000|Baseline|Sequence 1|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo"
11327302|NCT03406260|BG001|Baseline|Sequence 2|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg"
11327303|NCT03406260|BG002|Baseline|Sequence 3|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg"
11327304|NCT03406260|BG003|Baseline|Sequence 4|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg"
11327305|NCT03406260|BG004|Baseline|Sequence 5|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg"
11327306|NCT03406260|BG005|Baseline|Sequence 6|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo"
11327307|NCT03406260|BG006|Baseline|Total|Total of all reporting groups
11327308|NCT03406260|FG000|Participant Flow|Sequence 1|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo"
11327309|NCT03406260|FG001|Participant Flow|Sequence 2|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg"
11327310|NCT03406260|FG002|Participant Flow|Sequence 3|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg"
11327311|NCT03406260|FG003|Participant Flow|Sequence 4|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg"
11327312|NCT03406260|FG004|Participant Flow|Sequence 5|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg"
11327313|NCT03406260|FG005|Participant Flow|Sequence 6|"Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.~Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo"
11327314|NCT03406260|OG000|Outcome|Lasmiditan 200 mg|Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliters) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327315|NCT03406260|OG001|Outcome|Lasmiditan 100 mg|Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327316|NCT03406260|OG002|Outcome|Placebo|Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327317|NCT03406260|OG000|Outcome|Lasmiditan 100 mg|Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327318|NCT03406260|OG001|Outcome|Lasmiditan 200 mg|Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327319|NCT03406260|EG000|Reported Event|Lasmiditan 200 mg|Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327320|NCT03406260|EG001|Reported Event|Lasmiditan 100 mg|Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327321|NCT03406260|EG002|Reported Event|Placebo|Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
11327322|NCT03406325|BG000|Baseline|Validation Group|Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
11327323|NCT03406325|BG001|Baseline|SH#1|Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
11327324|NCT03406325|BG002|Baseline|SH#2|Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
11327325|NCT03406325|BG003|Baseline|SH#3|Female patient, Total IgE: 5333KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema
11327326|NCT03406325|BG004|Baseline|SH#4|Male patient, Total IgE: 4070KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema, Urticaria
11327327|NCT03406325|BG005|Baseline|SH#5|Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327328|NCT03406325|BG006|Baseline|SH#6|Female patient, Total IgE: 13KU/L; Der p2IgE: <0.1KU/L; clinical diagnosis: Mast cell activation syndrome
11327329|NCT03406325|BG007|Baseline|SH#7|Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
11327330|NCT03406325|BG008|Baseline|Total|Total of all reporting groups
11327331|NCT03406325|FG000|Participant Flow|Validation Group|Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
11327332|NCT03406325|FG001|Participant Flow|SH#1|Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
11327333|NCT03406325|FG002|Participant Flow|SH#2|Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
11327334|NCT03406325|FG003|Participant Flow|SH#3|Female patient, Total IgE: 5333KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema
11327335|NCT03406325|FG004|Participant Flow|SH#4|Male patient, Total IgE: 4070KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema, Urticaria
11327336|NCT03406325|FG005|Participant Flow|SH#5|Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327337|NCT03406325|FG006|Participant Flow|SH#6|Female patient, Total IgE: 13KU/L; Der p2IgE: <0.1KU/L; clinical diagnosis: Mast cell activation syndrome
11327338|NCT03406325|FG007|Participant Flow|SH#7|Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
11327339|NCT03406325|OG000|Outcome|Validation Group|Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
11327340|NCT03406325|OG001|Outcome|SH#1|Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
11327341|NCT03406325|OG002|Outcome|SH#2|Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
11327342|NCT03406325|OG003|Outcome|SH#3|Female patient, Total IgE: 5333 KU/L; Der p2 IgE: >100 KU/L; clinical diagnosis: Eczema
11327343|NCT03406325|OG004|Outcome|SH#4|Male patient, Total IgE: 4070 KU/L; Der p2 IgE: >100 KU/L; clinical diagnosis: Eczema, Urticaria
11327344|NCT03406325|OG005|Outcome|SH#5|Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327345|NCT03406325|OG006|Outcome|SH#6|Female patient, Total IgE: 13 KU/L; Der p2 IgE: <0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
11327346|NCT03406325|OG007|Outcome|SH#7|Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
11327347|NCT03406325|OG001|Outcome|SH#1|Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
11327348|NCT03406325|OG002|Outcome|SH#2|Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
11327349|NCT03406325|OG003|Outcome|SH#3|Female patient, Total IgE: 5333KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema
11327350|NCT03406325|OG004|Outcome|SH#4|Male patient, Total IgE: 4070KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema, Urticaria
11327351|NCT03406325|OG005|Outcome|SH#5|Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327352|NCT03406325|OG006|Outcome|SH#6|Female patient, Total IgE: 13KU/L; Der p2IgE: <0.1KU/L; clinical diagnosis: Mast cell activation syndrome
11327353|NCT03406325|OG007|Outcome|SH#7|Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
11327354|NCT03406325|OG000|Outcome|SH#1|Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
11327355|NCT03406325|OG001|Outcome|SH#2|Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
11327356|NCT03406325|OG002|Outcome|SH#3|Female patient, Total IgE: 5333KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema
11327357|NCT03406325|OG003|Outcome|SH#4|Male patient, Total IgE: 4070KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema, Urticaria
11327358|NCT03406325|OG004|Outcome|SH#5|Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327359|NCT03406325|OG005|Outcome|SH#6|Female patient, Total IgE: 13KU/L; Der p2IgE: <0.1KU/L; clinical diagnosis: Mast cell activation syndrome
11327360|NCT03406325|OG006|Outcome|SH#7|Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
11327361|NCT03406325|EG000|Reported Event|Validation Group|Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
11327362|NCT03406325|EG001|Reported Event|SH#1|Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
11327363|NCT03406325|EG002|Reported Event|SH#2|Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
11327364|NCT03406325|EG003|Reported Event|SH#3|Female patient, Total IgE: 5333KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema
11327365|NCT03406325|EG004|Reported Event|SH#4|Male patient, Total IgE: 4070KU/L; Der p2IgE: >100KU/L; clinical diagnosis: Eczema, Urticaria
11327366|NCT03406325|EG005|Reported Event|SH#5|Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
11327367|NCT03406325|EG006|Reported Event|SH#6|Female patient, Total IgE: 13KU/L; Der p2IgE: <0.1KU/L; clinical diagnosis: Mast cell activation syndrome
11327368|NCT03406325|EG007|Reported Event|SH#7|Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
11327369|NCT03406377|BG000|Baseline|Placebo|"Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate~Placebo: Placebo subcutaneous injection"
11327370|NCT03406377|BG001|Baseline|OPK-88003|"70 mg/vial (extractable volume 1 mL)~OPK-88003: OPK-88003 subcutaneous injection"
11327371|NCT03406377|BG002|Baseline|Total|Total of all reporting groups
11327372|NCT03406377|FG000|Participant Flow|Placebo|"Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate~Placebo: Placebo subcutaneous injection"
11327373|NCT03406377|FG001|Participant Flow|OPK-88003|"70 mg/vial (extractable volume 1 mL)~OPK-88003: OPK-88003 subcutaneous injection"
11327374|NCT03406377|OG000|Outcome|Placebo|"Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate~Placebo: Placebo subcutaneous injection"
11327375|NCT03406377|OG001|Outcome|OPK-88003|"70 mg/vial (extractable volume 1 mL)~OPK-88003: OPK-88003 subcutaneous injection"
11327376|NCT03406377|EG000|Reported Event|Placebo|"Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate~Placebo: Placebo subcutaneous injection"
11327377|NCT03406377|EG001|Reported Event|OPK-88003|"70 mg/vial (extractable volume 1 mL)~OPK-88003: OPK-88003 subcutaneous injection"
11327378|NCT03406962|BG000|Baseline|MGTA-456|MGTA-456 is an expanded CD34+ cell therapy investigational product used in replacement of single umbilical cord blood transplantation.
11327379|NCT03406962|FG000|Participant Flow|MGTA-456|MGTA-456 is an expanded CD34+ cell therapy investigational product used in replacement of single umbilical cord blood transplantation.
11327380|NCT03406962|OG000|Outcome|MGTA-456 Cohort 1|Patients receiving freshly-prepared MGTA-456 CD34+ cell therapy investigational product in replacement of single umbilical cord blood transplantation
11327381|NCT03406962|OG001|Outcome|MGTA-456 Cohort 2|Patients receiving cryopreserved MGTA-456 CD34+ cell therapy investigational product in replacement of single umbilical cord blood transplantation
11327382|NCT03406962|EG000|Reported Event|MGTA-456|"MGTA-456 is an expanded CD34+ cell therapy investigational product used in replacement of single umbilical cord blood transplantation.~."
11327383|NCT03407053|BG000|Baseline|Ultra-processed Diet Then Unprocessed Diet|"Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks~Ultra-processed diet: Consuming ultra-processed diet over a 2-week period~Unprocessed diet: Consuming unprocessed diet over a 2-week period"
11327384|NCT03407053|BG001|Baseline|Unprocessed Diet Then Ultra-processed Diet|"Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks~Ultra-processed diet: Consuming ultra-processed diet over a 2-week period~Unprocessed diet: Consuming unprocessed diet over a 2-week period"
11327385|NCT03407053|BG002|Baseline|Total|Total of all reporting groups
11327386|NCT03407053|FG000|Participant Flow|Ultra-processed Diet Then Unprocessed Diet|"Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks~Ultra-processed diet: Consuming ultra-processed diet over a 2-week period~Unprocessed diet: Consuming unprocessed diet over a 2-week period"
11327387|NCT03407053|FG001|Participant Flow|Unprocessed Diet Then Ultra-processed Diet|"Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks~Ultra-processed diet: Consuming ultra-processed diet over a 2-week period~Unprocessed diet: Consuming unprocessed diet over a 2-week period"
11327388|NCT03407053|OG000|Outcome|Ultra-processed Diet|Consuming ultra-processed diet over a 14 day period
11327389|NCT03407053|OG001|Outcome|Unprocessed Diet|Consuming unprocessed diet over a 14 day period
11327390|NCT03407053|EG000|Reported Event|Ultra-processed Diet|Consuming ultra-processed diet over a 14 day period
11327391|NCT03407053|EG001|Reported Event|Unprocessed Diet|Consuming unprocessed diet over a 14 day period
11327392|NCT03407118|BG000|Baseline|All Participants|All randomized participants who received at least 1 dose of study drug.
11327393|NCT03407118|FG000|Participant Flow|LY900014\Insulin Lispro (Humalog)|"Period 1: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) .~Period 2: A single dose of 15 U insulin lispro (Humalog) administered SC with up to 28 days between doses"
11327394|NCT03407118|FG001|Participant Flow|Insulin Lispro (Humalog)\LY900014|"Period 1: A single dose of 15 U insulin lispro (Humalog) administered SC.~Period 2: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) . with up to 28 days between doses."
11327395|NCT03407118|OG000|Outcome|15 U LY900014|A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) in one of two study periods.
11327396|NCT03407118|OG001|Outcome|15 U Insulin Lispro (Humalog)|A single dose of 15 U insulin lispro (Humalog) administered SC in one of two study periods.
11327397|NCT03407118|EG000|Reported Event|LY900014|A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) . in one of two study periods.
11327398|NCT03407118|EG001|Reported Event|Insulin Lispro (Humalog)|A single dose of 15 U insulin lispro (Humalog) administered SC in one of two study periods.
11327399|NCT03407170|BG000|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion Q3W.
11327400|NCT03407170|FG000|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W).
11327401|NCT03407170|OG000|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion Q3W.
11327402|NCT03407170|EG000|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg by IV infusion Q3W.
11327403|NCT03407313|BG000|Baseline|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
11327404|NCT03407313|FG000|Participant Flow|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
11327405|NCT03407313|OG000|Outcome|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
11327406|NCT03407313|EG000|Reported Event|Rotational Fractional Resection (1.5mm Diameter Device)|Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) in submentum
11327407|NCT03407430|BG000|Baseline|Pregabalin, Then Placebo|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327408|NCT03407430|BG001|Baseline|Placebo, Then Pregabalin|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327409|NCT03407430|BG002|Baseline|Total|Total of all reporting groups
11327410|NCT03407430|FG000|Participant Flow|Pregabalin, Then Placebo|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327411|NCT03407430|FG001|Participant Flow|Placebo, Then Pregabalin|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327412|NCT03407430|OG000|Outcome|First Intervention = Pregabalin|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg twice a day (BID) for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327413|NCT03407430|OG001|Outcome|First Intervention = Placebo|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11333741|NCT03519867|OG009|Outcome|10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333742|NCT03519867|EG000|Reported Event|1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327414|NCT03407430|OG000|Outcome|First Intervention = Pregabalin|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327415|NCT03407430|OG001|Outcome|Second Intervention = Placebo|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327416|NCT03407430|OG002|Outcome|First Intervention = Placebo|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327417|NCT03407430|OG003|Outcome|Second Intervention = Pregabalin|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327418|NCT03407430|OG001|Outcome|Second Intervention = Pregabalin|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327419|NCT03407430|EG000|Reported Event|First Intervention = Pregabalin|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11327420|NCT03407430|EG001|Reported Event|Second Intervention = Placebo|"Pregabalin in cycle 1; placebo in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Pregabalin: During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme."
11333743|NCT03519867|EG001|Reported Event|2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327421|NCT03407430|EG002|Reported Event|First Intervention = Placebo|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327422|NCT03407430|EG003|Reported Event|Second Intervention = Pregabalin|"Placebo in cycle 1; pregabalin in cycle 2.~Pregabalin or matching placebo will be administered at 75 mg BID for 4 days, to patients receiving pegfilgrastim for hematologic malignancies or breast cancer patients on myelosuppressive chemotherapy . Starting the day of pegfilgrastim, the dose of study medication will be increased to 150 mg PO BID provided the patient is tolerating the lower dose (ie, they are not experiencing any pregabalin associated toxicities >Grade 1). This will be determined by the research team on the day of pegfilgrastim administration.~Placebo: During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme."
11327423|NCT03407482|BG000|Baseline|GDC-0853 (200mg) BID|Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
11327424|NCT03407482|FG000|Participant Flow|GDC-0853 (200mg) BID|Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
11327425|NCT03407482|OG000|Outcome|GDC-0853 (200mg) BID|Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
11327426|NCT03407482|EG000|Reported Event|GDC-0853 (200mg) BID|Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
11327427|NCT03407612|BG000|Baseline|CPM Used|"These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.~Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness."
11327428|NCT03407612|BG001|Baseline|No CPM Used|No CPM was administered to these subjects.
11327429|NCT03407612|BG002|Baseline|Total|Total of all reporting groups
11327430|NCT03407612|FG000|Participant Flow|CPM Used|"These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.~Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness."
11327431|NCT03407612|FG001|Participant Flow|No CPM Used|No CPM was administered to these subjects.
11327432|NCT03407612|OG000|Outcome|CPM Used|"These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.~Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness."
11327433|NCT03407612|OG001|Outcome|No CPM Used|No CPM was administered to these subjects.
11327434|NCT03407612|EG000|Reported Event|CPM Used|"These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.~Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness."
11327435|NCT03407612|EG001|Reported Event|No CPM Used|No CPM was administered to these subjects.
11327436|NCT03407625|BG000|Baseline|Foley Bulb Plus Oral Misoprostol|"Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Foley bulb plus Oral Misoprostol: Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States."
11327437|NCT03407625|BG001|Baseline|Oral Misoprostol|"Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol."
11327438|NCT03407625|BG002|Baseline|Total|Total of all reporting groups
11327439|NCT03407625|FG000|Participant Flow|Foley Bulb Plus Oral Misoprostol|"Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Foley bulb plus Oral Misoprostol: Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States."
11327440|NCT03407625|FG001|Participant Flow|Oral Misoprostol|"Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol."
11327441|NCT03407625|OG000|Outcome|Foley Bulb Plus Oral Misoprostol|"Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Foley bulb plus Oral Misoprostol: Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States."
11327442|NCT03407625|OG001|Outcome|Oral Misoprostol|"Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol."
11327443|NCT03407625|EG000|Reported Event|Foley Bulb Plus Oral Misoprostol|"Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Foley bulb plus Oral Misoprostol: Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States."
11327444|NCT03407625|EG001|Reported Event|Oral Misoprostol|"Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol."
11327445|NCT03407651|BG000|Baseline|Safety Population|Safety Population
11327446|NCT03407651|FG000|Participant Flow|Overall Study Population|"Period 1: Part 1a~Coagulation Factor VIIa variant, 18 µg/kg by intravenous route~Coagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.~Period 2: Part 1b~Coagulation Factor VIIa variant, 30 µg/kg by subcutaneous route~Coagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.~Period 3: Part 2~Coagulation Factor VIIa variant, 30, 60, 90, 120 µg/kg by subcutaneous route~Coagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required."
11327447|NCT03407651|OG000|Outcome|Part 2|"MarzAA 30 and 60 µg/kg by subcutaneous route~Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required."
11327448|NCT03407651|OG000|Outcome|Part 1a, MarzAA IV 18 µg/kg|Single intravenous injection of MarzAA 18 µg/kg
11327449|NCT03407651|OG001|Outcome|Part 1b, MarzAA SC 30 µg/kg|Single subcutaneous injection of MarzAA 30 µg/kg
11327450|NCT03407651|OG002|Outcome|Part 2, MarzAA 30 µg/kg|MarzAA 30 µg/kg by subcutaneous injection daily for 50 days
11327451|NCT03407651|OG003|Outcome|Part 2, MarzAA 60 µg/kg|MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50
11327452|NCT03407651|OG000|Outcome|Part 1, MarzAA IV 18 µg/kg|Single intravenous infusion of MarzAA 18 µg/kg
11327453|NCT03407651|OG001|Outcome|Part 1, MarzAA SC 30 µg/kg|Single subcutaneous infusion of MarzAA 30 µg/kg
11327454|NCT03407651|OG000|Outcome|Part 1a, MarzAA IV 18 µg/kg|Single intravenous infusion of MarzAA 18 µg/kg
11327455|NCT03407651|OG001|Outcome|Part 1b, MarzAA SC 30 µg/kg|Single subcutaneous infusion of MarzAA 30 µg/kg
11327456|NCT03407651|OG000|Outcome|Part 1a|MarzAA 18 µg/kg by intravenous injection
10827910|NCT00112359|OG001|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
10827911|NCT00112359|EG000|Reported Event|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
11327457|NCT03407651|OG001|Outcome|Part 1b|MarzAA 30 µg/kg by subcutaneous injection
11327458|NCT03407651|OG003|Outcome|Part 2, MarzAA 60 ug/kg|MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50
11327459|NCT03407651|OG000|Outcome|Part 1a, MarzAA IV 18 µg/kg|MarzAA 18 ug/kg by intravenous injection
11327460|NCT03407651|OG001|Outcome|Part 1b, MarzAA SC 30 µg/kg|MarzAA 30 ug/kg by subcutaneous injection
11327461|NCT03407651|EG000|Reported Event|MarzAA IV 18 μg/kg|IV infusion of 18 ug/kg MarzAA, Part 1 of study
11327462|NCT03407651|EG001|Reported Event|MarzAA SC 30 μg/kg|SC infusion of MarzAA SC 30 μg/kg, Part 1 of study
11327463|NCT03407651|EG002|Reported Event|MarzAA 30 ug/kg|SC infusion of MarzAA 30 ug/kg, Part 2 of study
11327464|NCT03407651|EG003|Reported Event|MarzAA 60 ug/kg|SC infusion of MarzAA 60 ug/kg, Part 2 of study
11327465|NCT03408171|BG000|Baseline|19-gauge FNA Needle|"A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.~19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle."
11327466|NCT03408171|BG001|Baseline|19-gauge FNB Needle|"A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.~19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle."
11327467|NCT03408171|BG002|Baseline|Total|Total of all reporting groups
11327468|NCT03408171|FG000|Participant Flow|19-gauge FNA Needle|"A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.~19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle."
11327469|NCT03408171|FG001|Participant Flow|19-gauge FNB Needle|"A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.~19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle."
11327470|NCT03408171|OG000|Outcome|19-gauge FNA Needle|"A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.~19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle."
11327471|NCT03408171|OG001|Outcome|19-gauge FNB Needle|"A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.~19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle."
11327472|NCT03408171|EG000|Reported Event|19-gauge FNA Needle|"A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.~19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle."
11327473|NCT03408171|EG001|Reported Event|19-gauge FNB Needle|"A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.~19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle."
11327474|NCT03408392|BG000|Baseline|All Participants|Eligible participants received a single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) followed by Reference formulation (cefixime 200 mg/5 mL suspension) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11327475|NCT03408392|FG000|Participant Flow|SKF101804 Cefixime Followed by Cefixime Reference Formulation|Eligible participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 2.
11327476|NCT03408392|FG001|Participant Flow|Cefixime Reference Formulation Followed by SKF101804 Cefixime|Eligible participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 2.
11327477|NCT03408392|OG000|Outcome|SKF101804 Cefixime|Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11327478|NCT03408392|OG001|Outcome|Cefixime Reference Formulation|Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11327479|NCT03408392|EG000|Reported Event|SKF101804 Cefixime|Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11327480|NCT03408392|EG001|Reported Event|Cefixime Reference Formulation|Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
11327481|NCT03408483|BG000|Baseline|Quadratus Lumborum Block (QLB)|"Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.~After QLB is placed, patients will have THA under spinal anesthesia."
11327482|NCT03408483|BG001|Baseline|Standard of Care|"Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.~Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication."
11327483|NCT03408483|BG002|Baseline|Total|Total of all reporting groups
11327484|NCT03408483|FG000|Participant Flow|Quadratus Lumborum Block (QLB)|"Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.~After QLB is placed, patients will have THA under spinal anesthesia.~Quadratus Lumborum Block (QLB): Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle"
11333744|NCT03519867|EG002|Reported Event|3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11327485|NCT03408483|FG001|Participant Flow|Standard of Care|"Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.~Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication."
11327486|NCT03408483|OG000|Outcome|Quadratus Lumborum Block (QLB)|"Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.~After QLB is placed, patients will have THA under spinal anesthesia."
11327487|NCT03408483|OG001|Outcome|Standard of Care|"Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.~Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication."
11327488|NCT03408483|EG000|Reported Event|Quadratus Lumborum Block (QLB)|"Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.~After QLB is placed, patients will have THA under spinal anesthesia."
11327489|NCT03408483|EG001|Reported Event|Standard of Care|"Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.~Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.~Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication."
11327490|NCT03408639|BG000|Baseline|CinnaPoietin®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~CinnaPoietin®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327491|NCT03408639|BG001|Baseline|Eprex®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~Eprex®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327492|NCT03408639|BG002|Baseline|Total|Total of all reporting groups
11327493|NCT03408639|FG000|Participant Flow|CinnaPoietin®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~CinnaPoietin®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327494|NCT03408639|FG001|Participant Flow|Eprex®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~Eprex®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327495|NCT03408639|OG000|Outcome|CinnaPoietin®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~CinnaPoietin®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327496|NCT03408639|OG001|Outcome|Eprex®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~Eprex®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327497|NCT03408639|EG000|Reported Event|CinnaPoietin®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~CinnaPoietin®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327498|NCT03408639|EG001|Reported Event|Eprex®|"The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.~Eprex®: The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.~Nephrovit: Nephrovit tablet is daily administered to all the patients.~Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients."
11327499|NCT03408730|BG000|Baseline|Comparator: ENGERIX-B Hep B Vaccination|"Active Comparator: ENGERIX-B Hepatitis B Vaccination~Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327500|NCT03408730|BG001|Baseline|Sci-B-Vac Lot A Hep B Vaccination|"Sci-B-Vac Lot A Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327501|NCT03408730|BG002|Baseline|Sci-B-Vac Lot B Hep B Vaccination|"Sci-B-Vac Lot B Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327502|NCT03408730|BG003|Baseline|Sci-B-Vac Lot C Hep B Vaccination|"Sci-B-Vac Lot C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327503|NCT03408730|BG004|Baseline|Total|Total of all reporting groups
11327504|NCT03408730|FG000|Participant Flow|Comparator: ENGERIX-B Hep B Vaccination|"Active Comparator: ENGERIX-B Hepatitis B Vaccination~Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327505|NCT03408730|FG001|Participant Flow|Sci-B-Vac Lot A Hep B Vaccination|"Sci-B-Vac Lot A Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327506|NCT03408730|FG002|Participant Flow|Sci-B-Vac Lot B Hep B Vaccination|"Sci-B-Vac Lot B Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327507|NCT03408730|FG003|Participant Flow|Sci-B-Vac Lot C Hep B Vaccination|"Sci-B-Vac Lot C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327508|NCT03408730|OG000|Outcome|Sci-B-Vac Lot A Hep B Vaccination|"Sci-B-Vac Lot A Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327509|NCT03408730|OG001|Outcome|Sci-B-Vac Lot B Hep B Vaccination|"Sci-B-Vac Lot B Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327510|NCT03408730|OG002|Outcome|Sci-B-Vac Lot C Hep B Vaccination|"Sci-B-Vac Lot C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327511|NCT03408730|OG000|Outcome|Comparator: ENGERIX-B Hep B Vaccination|"Active Comparator: ENGERIX-B Hepatitis B Vaccination~Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327512|NCT03408730|OG001|Outcome|Pooled Sci-B-Vac®|"Pooled Sci-B-Vac Lot A, B and C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327513|NCT03408730|OG001|Outcome|Sci-B-Vac Lot A Hep B Vaccination|"Sci-B-Vac Lot A Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327514|NCT03408730|OG002|Outcome|Sci-B-Vac Lot B Hep B Vaccination|"Sci-B-Vac Lot B Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327515|NCT03408730|OG003|Outcome|Sci-B-Vac Lot C Hep B Vaccination|"Sci-B-Vac Lot C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327516|NCT03408730|EG000|Reported Event|Comparator: ENGERIX-B Hep B Vaccination|"Active Comparator: ENGERIX-B Hepatitis B Vaccination~Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327517|NCT03408730|EG001|Reported Event|Sci-B-Vac Lot A Hep B Vaccination|"Sci-B-Vac Lot A Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327518|NCT03408730|EG002|Reported Event|Sci-B-Vac Lot B Hep B Vaccination|"Sci-B-Vac Lot B Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327519|NCT03408730|EG003|Reported Event|Sci-B-Vac Lot C Hep B Vaccination|"Sci-B-Vac Lot C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168."
11327520|NCT03408808|BG000|Baseline|Aspiration Alone|"The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.~Aspiration alone: Aspiration of the ganglion"
11327521|NCT03408808|BG001|Baseline|Aspiration Plus Platelet Rich Plasma|"The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours.~Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma."
11327522|NCT03408808|BG002|Baseline|Total|Total of all reporting groups
11327523|NCT03408808|FG000|Participant Flow|Aspiration Alone|"The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.~Aspiration alone: Aspiration of the ganglion"
11327524|NCT03408808|FG001|Participant Flow|Aspiration Plus Platelet Rich Plasma|"The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours.~Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma."
11327525|NCT03408808|OG000|Outcome|Aspiration Alone|"The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.~Aspiration alone: Aspiration of the ganglion"
11327526|NCT03408808|OG001|Outcome|Aspiration Plus Platelet Rich Plasma|"The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours.~Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma."
11327527|NCT03408808|EG000|Reported Event|Aspiration Alone|"The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.~Aspiration alone: Aspiration of the ganglion"
11327528|NCT03408808|EG001|Reported Event|Aspiration Plus Platelet Rich Plasma|"The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours.~Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma."
10827912|NCT00112359|EG001|Reported Event|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
10827913|NCT00112385|BG000|Baseline|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
10827914|NCT00112385|BG001|Baseline|Placebo|Subjects will be given syringes containing placebo
11327529|NCT03409107|BG000|Baseline|Placebo|Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up.
11327530|NCT03409107|BG001|Baseline|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
11327531|NCT03409107|BG002|Baseline|Total|Total of all reporting groups
11327532|NCT03409107|FG000|Participant Flow|Placebo|Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up.
11327533|NCT03409107|FG001|Participant Flow|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
11327534|NCT03409107|OG000|Outcome|Placebo|Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up.
11327535|NCT03409107|OG001|Outcome|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
11327536|NCT03409107|EG000|Reported Event|Placebo|Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up.
11327537|NCT03409107|EG001|Reported Event|Daprodustat|Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
11327538|NCT03410056|BG000|Baseline|Phase 1b: Placebo|Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A [less frequent] or schedule B [more frequent]).
11327539|NCT03410056|BG001|Baseline|Phase 1b: Efavaleukin Alfa Cohort 1|A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327540|NCT03410056|BG002|Baseline|Phase 1b: Efavaleukin Alfa Cohort 2|A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327541|NCT03410056|BG003|Baseline|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327542|NCT03410056|BG004|Baseline|Total|Total of all reporting groups
11327543|NCT03410056|FG000|Participant Flow|Phase 1b: Placebo|Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A [less frequent] or schedule B [more frequent]).
11327544|NCT03410056|FG001|Participant Flow|Phase 1b: Efavaleukin Alfa Cohort 1|A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327545|NCT03410056|FG002|Participant Flow|Phase 1b: Efavaleukin Alfa Cohort 2|A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327546|NCT03410056|FG003|Participant Flow|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327547|NCT03410056|FG004|Participant Flow|Phase 1b: Efavaleukin Alfa Cohort 4|"A medium/high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.~No participants were enrolled into this cohort as the study was terminated prior to initiation of Cohort 4."
11327548|NCT03410056|FG005|Participant Flow|Phase 2a: Placebo|"Matching placebo administered via subcutaneous injection, depending on the recommended phase 2 dose (RP2D) and dosing schedule as determined in phase 1b, for a total of up to 12 weeks.~The study was terminated prior to the start of phase 2a and no participants were enrolled."
11327549|NCT03410056|FG006|Participant Flow|Phase 2a: Efavaleukin Alfa|"Efavaleukin alfa administered via subcutaneous injection depending on the RP2D and dosing schedule determined in phase 1b, for up to a total of up to 12 weeks.~The study was terminated prior to the start of phase 2a and no participants were enrolled."
11327550|NCT03410056|OG000|Outcome|Phase 1b: Placebo|Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A [less frequent] or schedule B [more frequent]).
11327551|NCT03410056|OG001|Outcome|Phase 1b: Efavaleukin Alfa Cohort 1|A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327552|NCT03410056|OG002|Outcome|Phase 1b: Efavaleukin Alfa Cohort 2|A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327553|NCT03410056|OG003|Outcome|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327554|NCT03410056|OG000|Outcome|Phase 2a: Placebo|"Matching placebo administered via subcutaneous injection, depending on the recommended phase 2 dose (RP2D) and dosing schedule as determined in phase 1b, for a total of up to 12 weeks.~The study was terminated prior to the start of phase 2a and no participants were enrolled."
10827915|NCT00112385|BG002|Baseline|Total|Total of all reporting groups
11327555|NCT03410056|OG001|Outcome|Phase 2a: Efavaleukin Alfa|"Efavaleukin alfa administered via subcutaneous injection depending on the RP2D and dosing schedule determined in phase 1b, for up to a total of up to 12 weeks.~The study was terminated prior to the start of phase 2a and no participants were enrolled."
11327556|NCT03410056|OG000|Outcome|Phase 1b: Efavaleukin Alfa Cohort 1|A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327557|NCT03410056|OG001|Outcome|Phase 1b: Efavaleukin Alfa Cohort 2|A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327558|NCT03410056|OG002|Outcome|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327559|NCT03410056|OG000|Outcome|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327560|NCT03410056|EG000|Reported Event|Phase 1b: Placebo|Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A [less frequent] or schedule B [more frequent]).
11327561|NCT03410056|EG001|Reported Event|Phase 1b: Efavaleukin Alfa Cohort 1|A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327562|NCT03410056|EG002|Reported Event|Phase 1b: Efavaleukin Alfa Cohort 2|A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
11327563|NCT03410056|EG003|Reported Event|Phase 1b: Efavaleukin Alfa Cohort 3|A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
11327564|NCT03410628|BG000|Baseline|gammaCore Active Device|"open label~gammaCore: Non-invasive vagal nerve stimulator"
11327565|NCT03410628|FG000|Participant Flow|gammaCore Active Device|"open label~gammaCore: Non-invasive vagal nerve stimulator"
11327566|NCT03410628|OG000|Outcome|gammaCore Active Device|"open label~gammaCore: Non-invasive vagal nerve stimulator"
11327567|NCT03410628|EG000|Reported Event|gammaCore Active Device|"open label~gammaCore: Non-invasive vagal nerve stimulator"
11327568|NCT03410797|BG000|Baseline|Voice Disorder Requiring Voice Therapy|"Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.~Inclusion of semi-occluded mask in voice therapy: Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice."
11327569|NCT03410797|FG000|Participant Flow|Voice Disorder Requiring Voice Therapy|"Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.~Inclusion of semi-occluded mask in voice therapy: Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice."
11327570|NCT03410797|OG000|Outcome|Voice Disorder Requiring Voice Therapy|"Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.~Inclusion of semi-occluded mask in voice therapy: Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice."
11327571|NCT03410797|OG000|Outcome|Voice Disorder Requiring Voice Therapy|"Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.~Inclusion of semi-occluded mask in voice therapy: Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice.~Three of the subjects carried a diagnosis of lesions and 8 subjects carried a diagnosis of muscle tension dysphonia."
11327572|NCT03410797|EG000|Reported Event|Voice Disorder Requiring Voice Therapy|"Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.~Inclusion of semi-occluded mask in voice therapy: Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice."
11327573|NCT03410862|BG000|Baseline|Elderberry Extract|"Patients will be supplied a liquid Elderberry Extract used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Elderberry Extract: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)"
11327574|NCT03410862|BG001|Baseline|Placebo|"Patients will be supplied a liquid Placebo medication (similar in appearance and taste of Elderberry Extract) used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Placebos: Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry"
11327575|NCT03410862|BG002|Baseline|Total|Total of all reporting groups
11327576|NCT03410862|FG000|Participant Flow|Elderberry Extract|"Patients will be supplied a liquid Elderberry Extract used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Elderberry Extract: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)"
11327577|NCT03410862|FG001|Participant Flow|Placebo|"Patients will be supplied a liquid Placebo medication (similar in appearance and taste of Elderberry Extract) used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Placebos: Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry"
11327578|NCT03410862|OG000|Outcome|Elderberry Extract|"Patients will be supplied a liquid Elderberry Extract used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Elderberry Extract: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)"
11327579|NCT03410862|OG001|Outcome|Placebo|"Patients will be supplied a liquid Placebo medication (similar in appearance and taste of Elderberry Extract) used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Placebos: Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry"
11327580|NCT03410862|EG000|Reported Event|Elderberry Extract|"Patients will be supplied a liquid Elderberry Extract used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Elderberry Extract: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)"
11327581|NCT03410862|EG001|Reported Event|Placebo|"Patients will be supplied a liquid Placebo medication (similar in appearance and taste of Elderberry Extract) used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days.~Placebos: Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry"
11327582|NCT03410914|BG000|Baseline|Hemopatch|"Application of hemopatch to the divided end of the pancreas during surgery~Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery."
11327583|NCT03410914|FG000|Participant Flow|Hemopatch|"Application of hemopatch to the divided end of the pancreas during surgery~Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery."
11327584|NCT03410914|OG000|Outcome|Hemopatch|"Application of hemopatch to the divided end of the pancreas during surgery~Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery."
11327585|NCT03410914|EG000|Reported Event|Hemopatch|"Application of hemopatch to the divided end of the pancreas during surgery~Hemopatch: Application of hemopatch to the divided end of the pancreas during surgery."
11327586|NCT03410953|BG000|Baseline|Fendrix|"The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine~Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine"
11327587|NCT03410953|FG000|Participant Flow|Fendrix|"The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine~Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine"
11327588|NCT03410953|OG000|Outcome|Fendrix|"The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine~Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine"
11327589|NCT03410953|EG000|Reported Event|Fendrix|"The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine~Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine"
11327590|NCT03411902|BG000|Baseline|Risedronate|"Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.~Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327591|NCT03411902|BG001|Baseline|Placebo|"Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.~Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327592|NCT03411902|BG002|Baseline|Total|Total of all reporting groups
11327593|NCT03411902|FG000|Participant Flow|Risedronate|"Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.~Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327594|NCT03411902|FG001|Participant Flow|Placebo|"Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.~Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327595|NCT03411902|OG000|Outcome|Risedronate|"Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.~Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327596|NCT03411902|OG001|Outcome|Placebo|"Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.~Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327597|NCT03411902|EG000|Reported Event|Risedronate|"Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.~Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327598|NCT03411902|EG001|Reported Event|Placebo|"Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.~Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy."
11327599|NCT03412019|BG000|Baseline|Control Group|no music
11327600|NCT03412019|BG001|Baseline|Intervention Group|Music: selections of Mozart piano sonatas
11327601|NCT03412019|BG002|Baseline|Total|Total of all reporting groups
11327602|NCT03412019|FG000|Participant Flow|Control Group|no music
11327603|NCT03412019|FG001|Participant Flow|Intervention Group|Music: selections of Mozart piano sonatas
11327604|NCT03412019|OG000|Outcome|Control Group|no music
11327605|NCT03412019|OG001|Outcome|Intervention Group|Music: selections of Mozart piano sonatas
11327606|NCT03412019|EG000|Reported Event|Control Group|no music
11327607|NCT03412019|EG001|Reported Event|Intervention Group|Music: selections of Mozart piano sonatas
11327608|NCT03412084|BG000|Baseline|Stand up Intervention|"four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting~Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans"
11327609|NCT03412084|BG001|Baseline|Control|No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
11327610|NCT03412084|BG002|Baseline|Total|Total of all reporting groups
11327611|NCT03412084|FG000|Participant Flow|Stand up Intervention|"four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting~Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans"
11327612|NCT03412084|FG001|Participant Flow|Control|No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
11327613|NCT03412084|OG000|Outcome|Stand up Intervention|"four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting~Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans"
11327614|NCT03412084|OG001|Outcome|Control|No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
11327615|NCT03412084|EG000|Reported Event|Stand up Intervention|"four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting~Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans"
11327616|NCT03412084|EG001|Reported Event|Control|No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group
11327617|NCT03412734|BG000|Baseline|Chlorhexidine Group|Chlorhexidine: Chlorhexidine preparation solutions
11327618|NCT03412734|BG001|Baseline|Iodine Group|Iodine: Iodine-based preparation solutions
11327619|NCT03412734|BG002|Baseline|Total|Total of all reporting groups
11327620|NCT03412734|FG000|Participant Flow|Chlorhexidine Group|Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions.
11327621|NCT03412734|FG001|Participant Flow|Iodine Group|Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution.
11327622|NCT03412734|OG000|Outcome|Chlorhexidine Group|Chlorhexidine: Chlorhexidine preparation solutions
11327623|NCT03412734|OG001|Outcome|Iodine Group|Iodine: Iodine-based preparation solutions
11327624|NCT03412734|EG000|Reported Event|Chlorhexidine Group|Chlorhexidine: Chlorhexidine preparation solutions
11327625|NCT03412734|EG001|Reported Event|Iodine Group|Iodine: Iodine-based preparation solutions
11327626|NCT03412929|BG000|Baseline|Honey Impregnated Dressing|"Honey Impregnated Dressing~Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage."
11327627|NCT03412929|FG000|Participant Flow|Honey Impregnated Dressing|"Honey Impregnated Dressing~Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage."
11327628|NCT03412929|OG000|Outcome|Honey Impregnated Dressing|"Honey Impregnated Dressing~Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage."
11327629|NCT03412929|EG000|Reported Event|Honey Impregnated Dressing|"Honey Impregnated Dressing~Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage."
11327630|NCT03413618|BG000|Baseline|Experimental: Rivaroxaban + Diosmin + Stocking|"treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~Diosmin: 600 mg q.d. for 12 month~compression stockings: above knee stocking for 12 month"
11327631|NCT03413618|BG001|Baseline|Control: Rivaroxaban + Stockings Only|"standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~compression stockings: above knee stocking for 12 month"
11327632|NCT03413618|BG002|Baseline|Total|Total of all reporting groups
11327633|NCT03413618|FG000|Participant Flow|Experimental: Rivaroxaban + Diosmin + Stockings|"treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~Diosmin: 600 mg q.d. for 12 month~compression stockings: above knee stocking for 12 month"
11327634|NCT03413618|FG001|Participant Flow|Control: Rivaroxaban + Stockings Only|"standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~compression stockings: above knee stocking for 12 month"
11327635|NCT03413618|OG000|Outcome|Experimental: Rivaroxaban + Diosmin + Stockings|"treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~Diosmin: 600 mg q.d. for 12 month~compression stockings: above knee stocking for 12 month"
11327636|NCT03413618|OG001|Outcome|Control: Rivaroxaban + Stockings Only|"standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~compression stockings: above knee stocking for 12 month"
11327637|NCT03413618|EG000|Reported Event|Study Group|"treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~Diosmin: 600 mg q.d. for 12 month~compression stockings: above knee stocking for 12 month"
11327638|NCT03413618|EG001|Reported Event|Control Group|"standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings~Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month~compression stockings: above knee stocking for 12 month"
11327639|NCT03414047|BG000|Baseline|Prexasertib Cohort 1|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
11327640|NCT03414047|BG001|Baseline|Prexasertib Cohort 2|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.
11327641|NCT03414047|BG002|Baseline|Prexasertib Cohort 3|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
11327642|NCT03414047|BG003|Baseline|Prexasertib Cohort 4|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
11327643|NCT03414047|BG004|Baseline|Total|Total of all reporting groups
11327644|NCT03414047|FG000|Participant Flow|Prexasertib Cohort 1|Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
11327645|NCT03414047|FG001|Participant Flow|Prexasertib Cohort 2|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.
11327646|NCT03414047|FG002|Participant Flow|Prexasertib Cohort 3|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
11327647|NCT03414047|FG003|Participant Flow|Prexasertib Cohort 4|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
11327648|NCT03414047|OG000|Outcome|Prexasertib Cohort 1|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
11327649|NCT03414047|OG001|Outcome|Prexasertib Cohort 2|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.
11327650|NCT03414047|OG002|Outcome|Prexasertib Cohort 3|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
11327651|NCT03414047|OG003|Outcome|Prexasertib Cohort 4|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
11327652|NCT03414047|OG000|Outcome|Prexasertib|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. (Participants combined from all the Cohorts 1 to 4)
11327653|NCT03414047|EG000|Reported Event|Prexasertib Cohort 1|Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
11327654|NCT03414047|EG001|Reported Event|Prexasertib Cohort 2|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.
11327655|NCT03414047|EG002|Reported Event|Prexasertib Cohort 3|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
11327656|NCT03414047|EG003|Reported Event|Prexasertib Cohort 4|Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
11327657|NCT03414359|BG000|Baseline|2% Lidocaine|2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)
11327658|NCT03414359|BG001|Baseline|3% Chloroprocaine|3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
11327659|NCT03414359|BG002|Baseline|Total|Total of all reporting groups
11327660|NCT03414359|FG000|Participant Flow|2% Lidocaine|2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)
11327661|NCT03414359|FG001|Participant Flow|3% Chloroprocaine|3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
11327662|NCT03414359|OG000|Outcome|2% Lidocaine|2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)
11327663|NCT03414359|OG001|Outcome|3% Chloroprocaine|3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
11327664|NCT03414359|EG000|Reported Event|2% Lidocaine|2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)
11327665|NCT03414359|EG001|Reported Event|3% Chloroprocaine|3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
11327666|NCT03415152|BG000|Baseline|Omacor (Omega-3-acid Ethyl Esters)|"Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.~Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication."
11327667|NCT03415152|FG000|Participant Flow|Omacor (Omega-3-acid Ethyl Esters)|"Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.~Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication."
11327668|NCT03415152|OG000|Outcome|Omacor (Omega-3-acid Ethyl Esters)|"Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.~Omacor (Omega-3-acid ethyl esters): Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication."
11327669|NCT03415152|OG000|Outcome|Omacor (Omega-3-acid Ethyl Esters)|Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who have been prescribed Omacor for at least 6 months.
11327670|NCT03415152|OG000|Outcome|Omacor (Omega-3-acid Ethyl Esters)|Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
11327671|NCT03415152|OG000|Outcome|Omacor (Omega-3-acid Ethyl Esters)|Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who have been prescribed Omacor for at least 6 months Visit 2 - Visit 1 (3 months)
11327672|NCT03415152|EG000|Reported Event|Omacor (Omega-3-acid Ethyl Esters)|Adult patients who signed informed consent and were included in the program with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia and who have been prescribed Omacor for at least 6 months.
11327673|NCT03415178|BG000|Baseline|Auto-Injector Device (AI)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, participants switched to other arm of SYDNEY device to receive Alirocumab 300 mg, self- administered (unsupervised) using new auto-injector device (SYDNEY) Q4W from Week 4 until Week 16 in the single arm treatment period added to LMT.
11327674|NCT03415178|BG001|Baseline|New Auto-injector Device (SYDNEY)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, same treatment (Alirocumab 300 mg) with the same device (SYDNEY) was self-administered, (unsupervised) Q4W until Week 16 in the single arm treatment period added to LMT. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16.
11327675|NCT03415178|BG002|Baseline|Total|Total of all reporting groups
11327676|NCT03415178|FG000|Participant Flow|Auto-Injector Device (AI)|Alirocumab 300 milligram (mg) subcutaneous (SC) injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, participants switched to other arm of SYDNEY device to receive Alirocumab 300 mg, self- administered (unsupervised) using new auto-injector device (SYDNEY) every 4 weeks (Q4W) from Week 4 until Week 16 in the single arm treatment period added to lipid modifying therapy (LMT).
11327677|NCT03415178|FG001|Participant Flow|New Auto-Injector Device (SYDNEY)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, same treatment (Alirocumab 300 mg) with the same device (SYDNEY) was self-administered, (unsupervised) Q4W until Week 16 in the single arm treatment period added to LMT. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16.
11327678|NCT03415178|OG000|Outcome|New Auto-Injector Device (SYDNEY)|All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
11327679|NCT03415178|OG000|Outcome|Auto-Injector Device (AI)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm period of 4 weeks added to LMT.
11327680|NCT03415178|OG001|Outcome|New Auto-Injector Device (SYDNEY)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm period of 4 weeks added to LMT.
11327681|NCT03415178|OG001|Outcome|New Auto-injector Device (SYDNEY)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm period of 4 weeks added to LMT.
11327682|NCT03415178|OG000|Outcome|New Auto-injector Device (SYDNEY)|All participants who were randomized to Alirocumab 300 mg SC injection using either AI device or SYDNEY in the parallel arm treatment period of 4 weeks and continued in single arm period, Alirocumab 300 mg self-administered (unsupervised) SC injection using SYDNEY device Q4W at Week 4, 8 and 12 in single arm period added to LMT. Duration of single arm treatment period was 12 weeks (i.e. from Week 4 to 16).
11327683|NCT03415178|EG000|Reported Event|Auto-Injector Device (AI) (Parallel Arm Period)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using AI device, on-site under supervision in the parallel arm period of 4 weeks added to LMT.
11327684|NCT03415178|EG001|Reported Event|New Auto-Injector Device (Parallel-arm Period)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm period of 4 weeks added to LMT.
11327685|NCT03415178|EG002|Reported Event|New Auto-Injector Device (Single-arm Period)|Alirocumab 300 mg SC injection on Week 0 (Day 1), self-administered using new auto-injector device (SYDNEY), on-site under supervision in the parallel arm treatment period of 4 weeks. From Week 4, same treatment (Alirocumab 300 mg) with the same device (SYDNEY) was self-administered, (unsupervised) Q4W at Week 4, 8 and 12 in the single arm treatment period. Duration of single arm treatment period was 12 weeks, i.e. from Week 4 to 16 added to LMT.
11327686|NCT03415243|BG000|Baseline|Treatment Group A|Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327687|NCT03415243|BG001|Baseline|Treatment Group B|Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327688|NCT03415243|BG002|Baseline|Total|Total of all reporting groups
11327689|NCT03415243|FG000|Participant Flow|Treatment Group A|Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 milligrams [mg] + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 milliliters (mL) of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327690|NCT03415243|FG001|Participant Flow|Treatment Group B|Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327691|NCT03415243|OG000|Outcome|Treatment Group A|Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327692|NCT03415243|OG001|Outcome|Treatment Group B|Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327693|NCT03415243|EG000|Reported Event|Treatment Group A|Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327694|NCT03415243|EG001|Reported Event|Treatment Group B|Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
11327695|NCT03415581|BG000|Baseline|Doxazosin (Placebo First)|"Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks followed by active maintenance on doxazasin 16 mg (or the highest tolerated dose) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327696|NCT03415581|BG001|Baseline|Doxazosin (Active First)|"Maintenance on a daily dose of oral doxazosin (up to 16 mg, or the highest tolerated dose) for 4 weeks, followed by maintenance on doxazosin 0 mg for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327697|NCT03415581|BG002|Baseline|Total|Total of all reporting groups
11327698|NCT03415581|FG000|Participant Flow|Placebo Doxazosin, Then Active Doxazosin|"Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327699|NCT03415581|FG001|Participant Flow|Active Doxazosin the Placebo Doxazosin|"Maintenance on a daily dose of oral doxazosin (16 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327700|NCT03415581|OG000|Outcome|Placebo|"Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327701|NCT03415581|OG001|Outcome|Doxazosin|"Maintenance on a daily dose of oral doxazosin (16 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.~Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.~Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues."
11327702|NCT03415581|OG000|Outcome|Placebo|Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks, Under placebo maintenance the effects of intranasal oxycodone were assessed.
11327703|NCT03415581|OG001|Outcome|Doxazosin|Maintenance on a daily dose of oral doxazosin (16 mg, or the highest tolerated dose) for 4-weeks. Under doxazosin maintenance the effects of intranasal oxycodone were assessed.
11327704|NCT03415581|EG000|Reported Event|Placebo Maintenance|Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks.
11327705|NCT03415581|EG001|Reported Event|Doxazosin Maintenance|Maintenance on a daily dose of oral doxazosin (16 mg, or the highest tolerated dose) for 4-weeks.
11327706|NCT03416127|BG000|Baseline|Propolis|"Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.~Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks."
11327707|NCT03416127|BG001|Baseline|Metformin|"Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.~Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks."
11327708|NCT03416127|BG002|Baseline|Placebo|"Placebo capsules, two times per day before break-fast and dinner during 12 weeks.~Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks."
11327709|NCT03416127|BG003|Baseline|Total|Total of all reporting groups
11327710|NCT03416127|FG000|Participant Flow|Propolis|"Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.~Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks."
11327711|NCT03416127|FG001|Participant Flow|Metformin|"Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.~Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks."
11327712|NCT03416127|FG002|Participant Flow|Placebo|"Placebo capsules, two times per day before break-fast and dinner during 12 weeks.~Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks."
11327713|NCT03416127|OG000|Outcome|Propolis|"Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.~Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks."
11327714|NCT03416127|OG001|Outcome|Metformin|"Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.~Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks."
11327715|NCT03416127|OG002|Outcome|Placebo|"Placebo capsules, two times per day before break-fast and dinner during 12 weeks.~Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks."
11327716|NCT03416127|OG002|Outcome|Placebo|"Placebo capsules, two times per day before break-fast and dinner during 12 weeks.~Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.~Period Title: Overall Study"
11327717|NCT03416127|EG000|Reported Event|Propolis|"Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.~Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks."
11327718|NCT03416127|EG001|Reported Event|Metformin|"Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.~Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks."
11327719|NCT03416127|EG002|Reported Event|Placebo|"Placebo capsules, two times per day before break-fast and dinner during 12 weeks.~Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks."
11327720|NCT03416621|BG000|Baseline|Experimental: Cue-based Treatment|"Enhanced cue exposure treatment (lab-based + interactive SMS texting)~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages"
11327721|NCT03416621|BG001|Baseline|Comparator: Standard Counseling|Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
11327722|NCT03416621|BG002|Baseline|Active Comparator: Counseling and Active Drug Intervention|"enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages~Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit."
11327723|NCT03416621|BG003|Baseline|Total|Total of all reporting groups
11327724|NCT03416621|FG000|Participant Flow|Experimental: Cognitive Behavioral Cessation Counseling|"Standard smoking cessation plus support text messages~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages"
11327725|NCT03416621|FG001|Participant Flow|Placebo Comparator: Counseling and Placebo Drug Intervention|"enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages~Counseling and placebo drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo"
11327726|NCT03416621|FG002|Participant Flow|Active Comparator: Counseling and Active Drug Intervention|"enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages~Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit."
11327727|NCT03416621|OG000|Outcome|Experimental: Cue-based Treatment|"enhanced cue exposure treatment (lab-based + interactive SMS texting)~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages"
11327728|NCT03416621|OG001|Outcome|Control: Standard Counseling|Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
11327729|NCT03416621|OG002|Outcome|Active Comparator: Counseling and Active Drug Intervention|"enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages~Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit."
11327730|NCT03416621|OG000|Outcome|Total|Standard smoking cessation plus support text messages
11327731|NCT03416621|OG002|Outcome|Active Comparator: Counseling and Active Drug Intervention|"Enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit."
11327732|NCT03416621|EG000|Reported Event|Experimental: Cognitive Behavioral Cessation Counseling|Standard smoking cessation plus support text messages Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
11327733|NCT03416621|EG001|Reported Event|Placebo Comparator: Counseling and Placebo Drug Intervention|Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and placebo drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
11327734|NCT03416621|EG002|Reported Event|Active Comparator: Counseling and Active Drug Intervention|"Enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.~Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit."
11327735|NCT03416946|BG000|Baseline|Custom Block Instrumentation|"Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system~Visionaire: Custom cutting block using MRI to create patient specific instrumentations"
11327736|NCT03416946|BG001|Baseline|Traditional Instrumentation|"Traditional cutting methods for Total Knee Replacement~Traditional: Traditional cutting method"
11327737|NCT03416946|BG002|Baseline|Total|Total of all reporting groups
11327738|NCT03416946|FG000|Participant Flow|Custom Block Instrumentation|"Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system~Visionaire: Custom cutting block using MRI to create patient specific instrumentations"
11327739|NCT03416946|FG001|Participant Flow|Traditional Instrumentation|"Traditional cutting methods for Total Knee Replacement~Traditional: Traditional cutting method"
11327740|NCT03416946|OG000|Outcome|Custom Block Instrumentation|"Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system~Visionaire: Custom cutting block using MRI to create patient specific instrumentations"
11327741|NCT03416946|OG001|Outcome|Traditional Instrumentation|"Traditional cutting methods for Total Knee Replacement~Traditional: Traditional cutting method"
11327742|NCT03416946|EG000|Reported Event|Custom Block Instrumentation|"Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system~Visionaire: Custom cutting block using MRI to create patient specific instrumentations"
11327743|NCT03416946|EG001|Reported Event|Traditional Instrumentation|"Traditional cutting methods for Total Knee Replacement~Traditional: Traditional cutting method"
11327744|NCT03416985|BG000|Baseline|Pulsating Toothbrush|Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
11327745|NCT03416985|BG001|Baseline|Sonic Toothbrush|"Patients were asked to use a sonic toothbrush for 30 days~BURST Sonic Oral Care: Electric sonic toothbrush"
10827916|NCT00112385|FG000|Participant Flow|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
10827917|NCT00112385|FG001|Participant Flow|Placebo|Subjects will be given syringes containing placebo
11327746|NCT03416985|BG002|Baseline|Manual Toothbrush|Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
11327747|NCT03416985|BG003|Baseline|Total|Total of all reporting groups
11327748|NCT03416985|FG000|Participant Flow|Pulsating Toothbrush|Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
11327749|NCT03416985|FG001|Participant Flow|Sonic Toothbrush|"Patients were asked to use a sonic toothbrush for 30 days~BURST Sonic Oral Care: Electric sonic toothbrush"
11327750|NCT03416985|FG002|Participant Flow|Manual Toothbrush|Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
11327751|NCT03416985|OG000|Outcome|Pulsating Toothbrush|Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
11327752|NCT03416985|OG001|Outcome|Sonic Toothbrush|"Patients were asked to use a sonic toothbrush for 30 days~BURST Sonic Oral Care: Electric sonic toothbrush"
11327753|NCT03416985|OG002|Outcome|Manual Toothbrush|Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
11327754|NCT03416985|OG000|Outcome|Manual Toothbrush|"Patients will be asked to use a manual toothbrush for 30 days~Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush"
11327755|NCT03416985|OG001|Outcome|Sonic Toothbrush|"Patients will be asked to use a sonic toothbrush for 30 days~BURST Sonic Oral Care: Electric sonic toothbrush"
11327756|NCT03416985|OG002|Outcome|Pulsating Toothbrush|"Patients will be asked to use a pulsating toothbrush for 30 days~Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush"
11327757|NCT03416985|EG000|Reported Event|Manual Toothbrush|"Patients will be asked to use a manual toothbrush for 30 days~Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush"
11327758|NCT03416985|EG001|Reported Event|Sonic Toothbrush|"Patients will be asked to use a sonic toothbrush for 30 days~BURST Sonic Oral Care: Electric sonic toothbrush"
11327759|NCT03416985|EG002|Reported Event|Pulsating Toothbrush|"Patients will be asked to use a pulsating toothbrush for 30 days~Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush"
11327760|NCT03417024|BG000|Baseline|All Subjects|"All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.~Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.~Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues."
11327761|NCT03417024|FG000|Participant Flow|All Subjects|"All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.~Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.~Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues."
11327762|NCT03417024|OG000|Outcome|All Subjects|"All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.~Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.~Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues."
11327763|NCT03417024|EG000|Reported Event|All Subjects|"All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.~Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.~Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues."
11327764|NCT03417141|BG000|Baseline|Valchor Treatment of Lichen Planopilaris|"Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.~Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris."
11327765|NCT03417141|FG000|Participant Flow|Valchor Treatment of Lichen Planopilaris|"Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.~Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris."
11327766|NCT03417141|OG000|Outcome|Valchor Treatment of Lichen Planopilaris|"Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.~Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris."
11327767|NCT03417141|EG000|Reported Event|Valchor Treatment of Lichen Planopilaris|"Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.~Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris."
11095184|NCT01556724|FG001|Participant Flow|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11095185|NCT01556724|OG000|Outcome|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11327768|NCT03417219|BG000|Baseline|Mobile Media Education and Skill-Building Rehabilitation Int|"The investigators' ESBR-m intervention consists of four, 90-minute group (<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.~Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session."
11327769|NCT03417219|BG001|Baseline|Usual Care|"Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss).~Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss)."
11327770|NCT03417219|BG002|Baseline|Total|Total of all reporting groups
11327771|NCT03417219|FG000|Participant Flow|Mobile Media Education and Skill-Building Rehabilitation Int|"The investigators' ESBR-m intervention consists of four, 90-minute group (<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.~Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session."
11327772|NCT03417219|FG001|Participant Flow|Usual Care|"Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss).~Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss)."
11327773|NCT03417219|OG000|Outcome|Mobile Media Education and Skill-Building Rehabilitation Int|"The investigators' ESBR-m intervention consists of four, 90-minute group (<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.~Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session."
11327774|NCT03417219|OG001|Outcome|Usual Care|"Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss).~Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss)."
11327775|NCT03417219|EG000|Reported Event|Mobile Media Education and Skill-Building Rehabilitation Int|"The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.~Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session."
11327776|NCT03417219|EG001|Reported Event|Usual Care|"Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss).~Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss)."
11327777|NCT03417466|BG000|Baseline|Study Arm|Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
11218023|NCT02318602|FG002|Participant Flow|Adolescents|"Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
10827918|NCT00112385|OG000|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
10827919|NCT00112385|OG001|Outcome|Placebo|Subjects will be given syringes containing placebo
11327778|NCT03417466|FG000|Participant Flow|Study Arm|Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
11327779|NCT03417466|OG000|Outcome|Study Arm|Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
11327780|NCT03417466|EG000|Reported Event|Study Arm|Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
11327781|NCT03417505|BG000|Baseline|Participants|As this was a crossover study, all participants work both the Hydra-PEG treated and untreated lenses. Therefore, the baseline characteristics were the same for both groups.
11327782|NCT03417505|FG000|Participant Flow|Hydra-PEG Treated Lenses Followed by Untreated Lenses|Hydra-PEG treated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing untreated lenses
11327783|NCT03417505|FG001|Participant Flow|Untreated Lenses Followed by Hydra-PEG Treated Lenses|Untreated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing Hydra-PEG treated lenses
11327784|NCT03417505|OG000|Outcome|Hydra-PEG Treated Lens Wearers|Patients wearing the Hydra-PEG treated lenses
11327785|NCT03417505|OG001|Outcome|Untreated Lens Wearers|Patients wearing lenses without the Hydra-PEG treatment
11327786|NCT03417505|EG000|Reported Event|Hydra-PEG Treated Lenses Followed by Untreated Lenses|Participants wore Hydra-PEG lenses for 30 days, followed by a 7 day washout period and then 30 days wearing untreated lenses.
11327787|NCT03417505|EG001|Reported Event|Untreated Lenses Followed by Hydra-PEG Treated Lenses|Participants wore untreated lenses for 30 days, followed by a 7 day washout period and then 30 days wearing Hydra-PEG treated lenses.
11327788|NCT03417557|BG000|Baseline|Comfilcon A Lens (Test) and Omafilcon B (Control)|Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study.
11327789|NCT03417557|FG000|Participant Flow|Comfilcon A Lens Then Omafilcon B Lens|"Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study.~Comfilcon A lens (test): contact lens"
11327790|NCT03417557|FG001|Participant Flow|Omafilcon B Lens Then Comfilcon A|"Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study.~Omafilcon B lens (control): contact lens"
11327791|NCT03417557|OG000|Outcome|Comfilcon A Lens (Test)|"Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.~Comfilcon A lens (test): contact lens"
11327792|NCT03417557|OG001|Outcome|Omafilcon B Lens (Control)|"Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.~Omafilcon B lens (control): contact lens"
11327793|NCT03417557|EG000|Reported Event|Comfilcon A Lens (Test)|"Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.~Comfilcon A lens (test): contact lens"
11327794|NCT03417557|EG001|Reported Event|Omafilcon B Lens (Control)|"Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.~Omafilcon B lens (control): contact lens"
11327795|NCT03417713|BG000|Baseline|All Subjects|"This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.~Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed."
11327796|NCT03417713|FG000|Participant Flow|All Subjects|"This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.~Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed."
11327797|NCT03417713|OG000|Outcome|All Subjects|"This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.~Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed."
11327798|NCT03417713|EG000|Reported Event|All Subjects|"This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.~Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed."
11327799|NCT03417739|BG000|Baseline|BVD-523|BVD-523 is administered at the RP2D of 600mgs taken twice daily orally for 28 consecutive days (1 cycle). Planned does may modified based on toxicity.
11327800|NCT03417739|FG000|Participant Flow|BVD-523|BVD-523 is administered at the RP2D of 600mgs taken twice daily orally for 28 consecutive days (1 cycle). Planned does may modified based on toxicity.
11327801|NCT03417739|OG000|Outcome|BVD-523|BVD-523 is administered at the RP2D of 600mgs taken twice daily orally for 28 consecutive days (1 cycle). Planned does may modified based on toxicity.
11327802|NCT03417739|EG000|Reported Event|BVD-523|"BVD-523 is administered at the RP2D of 600mgs taken twice daily orally for 28 consecutive days (1 cycle). Planned does may modified based on toxicity.~BVD-523: ERK1 and ERK2 inhibitor"
11327803|NCT03417752|BG000|Baseline|Exposure to Firearm Safety Public Service Announcement (PSA)|"Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.~Exposure to firearm safety PSA: Exposed to firearm safety PSA"
11327804|NCT03417752|BG001|Baseline|Exposure to a Mix of PSAs|"Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.~Exposure to firearm safety PSA: Exposed to firearm safety PSA~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327805|NCT03417752|BG002|Baseline|Active Control|"Exposure to the general health promotion video once per week for 3 weeks.~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327806|NCT03417752|BG003|Baseline|Total|Total of all reporting groups
10827920|NCT00112385|EG000|Reported Event|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
10827921|NCT00112385|EG001|Reported Event|Placebo|Subjects will be given syringes containing placebo
10827922|NCT00112437|BG000|Baseline|Placebo-Base|One placebo tablet once a week
10827923|NCT00112437|BG001|Baseline|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
10827924|NCT00112437|BG002|Baseline|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
10827925|NCT00112437|BG003|Baseline|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
10827926|NCT00112437|BG004|Baseline|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
10827927|NCT00112437|BG005|Baseline|Total|Total of all reporting groups
10827928|NCT00112437|FG000|Participant Flow|Placebo-Base|One placebo tablet once a week
10827929|NCT00112437|FG001|Participant Flow|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
10827930|NCT00112437|FG002|Participant Flow|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
10827931|NCT00112437|FG003|Participant Flow|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
10827932|NCT00112437|FG004|Participant Flow|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
10827933|NCT00112437|FG005|Participant Flow|Placebo-Ext 1|One placebo tablet once a week
10827934|NCT00112437|FG006|Participant Flow|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
10827935|NCT00112437|FG007|Participant Flow|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
10827936|NCT00112437|FG008|Participant Flow|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
10827937|NCT00112437|FG009|Participant Flow|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
11327807|NCT03417752|FG000|Participant Flow|Exposure to Firearm Safety PSA|"Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.~Exposure to firearm safety PSA: Exposed to firearm safety PSA"
11327808|NCT03417752|FG001|Participant Flow|Exposure to a Mix of PSAs|"Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.~Exposure to firearm safety PSA: Exposed to firearm safety PSA~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327809|NCT03417752|FG002|Participant Flow|Active Control|"Exposure to the general health promotion video once per week for 3 weeks.~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327810|NCT03417752|OG000|Outcome|Exposure to Firearm Safety PSA|"Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.~Exposure to firearm safety PSA: Exposed to firearm safety PSA"
11327811|NCT03417752|OG001|Outcome|Exposure to a Mix of PSAs|"Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.~Exposure to firearm safety PSA: Exposed to firearm safety PSA~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327812|NCT03417752|OG002|Outcome|Active Control|"Exposure to the general health promotion video once per week for 3 weeks.~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327813|NCT03417752|EG000|Reported Event|Exposure to Firearm Safety PSA|"Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.~Exposure to firearm safety PSA: Exposed to firearm safety PSA"
11327814|NCT03417752|EG001|Reported Event|Exposure to a Mix of PSAs|"Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.~Exposure to firearm safety PSA: Exposed to firearm safety PSA~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327815|NCT03417752|EG002|Reported Event|Active Control|"Exposure to the general health promotion video once per week for 3 weeks.~Exposure to health promotion PSA: Exposed to general health promotion PSA"
11327816|NCT03417778|BG000|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327817|NCT03417778|BG001|Baseline|Healthy Control|Matched healthy control participants received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327818|NCT03417778|BG002|Baseline|Total|Total of all reporting groups
11327819|NCT03417778|FG000|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327820|NCT03417778|FG001|Participant Flow|Healthy Control|Matched healthy control participants received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327821|NCT03417778|OG000|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327822|NCT03417778|OG001|Outcome|Healthy Control|Matched healthy control participants received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327823|NCT03417778|EG000|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327824|NCT03417778|EG001|Reported Event|Healthy Control|Matched healthy control participants received a single dose of filgotinib 100 mg administered orally on Day 1, in a fasted state.
11327825|NCT03417804|BG000|Baseline|Patients Proposed for Elective Surgical Procedures|A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
11327826|NCT03417804|FG000|Participant Flow|Patients Proposed for Elective Surgical Procedures|A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
11327827|NCT03417804|OG000|Outcome|Patients Proposed for Elective Surgical Procedures|"A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals~20 patients out of 366 presented with TOFr< 0.9 which represents an incidence of 5,5%"
11327828|NCT03417804|OG000|Outcome|Patients Proposed for Elective Surgical Procedures|A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
11327829|NCT03417804|EG000|Reported Event|Patients Proposed for Elective Surgical Procedures|A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
11327830|NCT03417830|BG000|Baseline|Part A: Anti-SAP|Participants with either wild type or ATTR-CM were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 mg per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb.
11333745|NCT03519867|EG003|Reported Event|4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
10827938|NCT00112437|FG010|Participant Flow|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
10827939|NCT00112437|FG011|Participant Flow|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
10827940|NCT00112437|FG012|Participant Flow|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
11333746|NCT03519867|EG004|Reported Event|5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333747|NCT03519867|EG005|Reported Event|6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333748|NCT03519867|EG006|Reported Event|7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333749|NCT03519867|EG007|Reported Event|8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333750|NCT03519867|EG008|Reported Event|9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333751|NCT03519867|EG009|Reported Event|10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg|Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
11333752|NCT03519919|BG000|Baseline|Overall Study|Total Participants
11333753|NCT03519919|FG000|Participant Flow|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~somofilcon A multifocal lens: contact lens"
11333754|NCT03519919|OG000|Outcome|Habitual Lens -Distance Vision While Driving During the Day|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens: Habitual Lens"
11333755|NCT03519919|OG001|Outcome|Habitual Lens - Distance Tasks in Good Lighting.|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens: Habitual Lens"
11333756|NCT03519919|OG002|Outcome|Habitual Lens - Distance Tasks in General|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens: Habitual Lens"
11333757|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens - Distance Vision While Driving|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment..~Contact lens : somofilcon A multifocal lens"
11333758|NCT03519919|OG001|Outcome|Somofilcon A Multifocal Lens -Distance Tasks in Good Lighting|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact lens : somofilcon A multifocal lens"
11333759|NCT03519919|OG002|Outcome|Somofilcon A Multifocal Lens-Distance Tasks in General|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact lens : somofilcon A multifocal lens"
11333760|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Lens Centration at baseline.~Contact Lens: Habitual Lens"
11333761|NCT03519919|OG001|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Lens Centration at baseline.~Contact lens : somofilcon A multifocal lens"
11333762|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Lens Centration Contact lens : somofilcon A multifocal lens
11333763|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and - Lens Centration at baseline.~Contact Lens: Habitual Lens"
11333764|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and - Visual Acuity Contact lens : somofilcon A multifocal lens
11333765|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Post blink movement at baseline.~Contact Lens: Habitual Lens"
11333766|NCT03519919|OG001|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Post blink movement at baseline.~Contact lens : somofilcon A multifocal lens"
11333767|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment - Post blink movement~Contact lens : somofilcon A multifocal lens"
11333768|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Corneal Staining at Baseline.~Contact Lens: Habitual Lens"
11333769|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and - corneal staining Contact lens : somofilcon A multifocal lens
11333770|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Conjunctival Staining at Baseline.~Contact Lens: Habitual Lens"
11333771|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - conjunctival staining Contact lens : somofilcon A multifocal lens
11333772|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - Bulbar hyperemia at Baseline.~Contact Lens: Habitual Lens"
11333773|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens - bulbar hyperemia Contact lens : somofilcon A multifocal lens
11333774|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens: Habitual Lens"
11327831|NCT03417830|BG001|Baseline|Part B: Anti-SAP|Participants with either wild type or ATTR-CM were planned to undergo one dosing sessions. Participants were planned to be administered 200 mg/mL GSK2315698 via intravenous infusion for 48 hours followed by administration of 100 mg/mL GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants were planned to receive a subcutaneous injection of GSK2315698 thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 2 PET scans were planned to be performed after the end of 89Zr-GSK2398852 infusion.
11327832|NCT03417830|BG002|Baseline|Total|Total of all reporting groups
11327833|NCT03417830|FG000|Participant Flow|Part A: Anti-SAP|Participants with either wild type or inherited transthyretin amyloidosis restrictive cardiomyopathy (ATTR-CM) were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 milligram (mg) per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg(session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 positron emission tomography (PET) scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb.
11327834|NCT03417830|FG001|Participant Flow|Part B: Anti-SAP|Participants with either wild type or ATTR-CM were planned to undergo one dosing sessions. Participants were planned to be administered 200 mg/mL GSK2315698 via intravenous infusion for 48 hours followed by administration of 100 mg/mL GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants were planned to receive a subcutaneous injection of GSK2315698 thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 2 PET scans were planned to be performed after the end of 89Zr-GSK2398852 infusion.
11327835|NCT03417830|OG000|Outcome|Part A: Anti-SAP- Session 1|Participants with either wild type or inherited ATTR-CM were included. In dosing session 1, participants were administered (dependent on renal function) 20 mg/hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session 1) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion.
11327836|NCT03417830|OG000|Outcome|Part A: Anti-SAP- Session 2|Participants with either wild type or inherited ATTR-CM were included. In dosing session 2, participants were administered (dependent on renal function) 20 mg/hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 490 mg (session 2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion.
11327837|NCT03417830|OG000|Outcome|Part B: Anti-SAP|Participants with either wild type or ATTR-CM were planned to undergo one dosing sessions. Participants were planned to be administered 200 mg/mL GSK2315698 via intravenous infusion for 48 hours followed by administration of 100 mg/mL GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants were planned to receive a subcutaneous injection of GSK2315698 thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 2 PET scans were planned to be performed after the end of 89Zr-GSK2398852 infusion.
11327838|NCT03417830|OG000|Outcome|Part A: Anti-SAP|Participants with either wild type or ATTR-CM were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 mg per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb.
11327839|NCT03417830|EG000|Reported Event|Part A: Anti-SAP|Participants with either wild type or ATTR-CM were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 mg per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb.
11327840|NCT03418051|BG000|Baseline|Control|Control group that will receive no intervention throughout the duration of the study (2-weeks).
11327841|NCT03418051|BG001|Baseline|Joint Mobilization|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
11327842|NCT03418051|BG002|Baseline|Massage|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
11327843|NCT03418051|BG003|Baseline|Total|Total of all reporting groups
11327844|NCT03418051|FG000|Participant Flow|Control|Control group that will receive no intervention throughout the duration of the study (2-weeks).
11327845|NCT03418051|FG001|Participant Flow|Joint Mobilization|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
11327846|NCT03418051|FG002|Participant Flow|Massage|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
11327847|NCT03418051|OG000|Outcome|Control|Control group that will receive no intervention throughout the duration of the study (2-weeks).
11327848|NCT03418051|OG001|Outcome|Joint Mobilization|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
11327849|NCT03418051|OG002|Outcome|Massage|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
11327850|NCT03418051|EG000|Reported Event|Control|Control group that will receive no intervention throughout the duration of the study (2-weeks).
11327851|NCT03418051|EG001|Reported Event|Joint Mobilization|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
11327852|NCT03418051|EG002|Reported Event|Massage|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
11327853|NCT03418064|BG000|Baseline|Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens|Each subject is randomized to wear either the fanfilcon A toric or lotrafilcon B toric contact lens as a matched pair and crossed over to second matched pair.
11327854|NCT03418064|FG000|Participant Flow|Fanfilcon A Toric, Then Lotrafilcon B Toric|"Subjects wore fanfilcon A toric contact lens for 1 month, then lotrafilcon B toric contact lens.~Fanfilcon A toric: contact lens Lotrafilcon B toric: contact lens"
11327855|NCT03418064|FG001|Participant Flow|Lotrafilcon B Toric, Then Fanfilcon A Toric|"Subjects wore lotrafilcon B toric contact lens for 1 month, then fanfilcon A toric contact lens.~Lotrafilcon B toric: Contact lens Fanfilcon A toric: contact lens"
11327856|NCT03418064|OG000|Outcome|Habitual Toric Lens at Baseline|Subjects were evaluated at baseline with their habitual toric lenses.
11327857|NCT03418064|OG000|Outcome|Fanfilcon A Toric at Dispense|"Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Fanfilcon A toric lens: Contact lens"
11327858|NCT03418064|OG001|Outcome|Lotrafilcon B Toric at Dispense|"Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Lotrafilcon B toric lens: Contact lens"
11327859|NCT03418064|OG000|Outcome|Fanfilcon A Toric Lens at 1 Month|"Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Fanfilcon A toric lens: Contact lens"
11327860|NCT03418064|OG001|Outcome|Lotrafilcon B Toric at 1 Month|"Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Lotrafilcon B toric lens: Contact lens"
11327861|NCT03418064|OG000|Outcome|Fanfilcon A Toric Contact Lens Dispense|"Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Fanfilcon A toric lens: Contact lens"
11327862|NCT03418064|OG001|Outcome|Lotrafilcon B Toric Contact Lens Dispense|"Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~lotrafilcon B toric lens: Contact lens"
11327863|NCT03418064|OG000|Outcome|Fanfilcon A Toric Contact Lens 1 Month|"Subjects who wore fanfilcon A toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~Fanfilcon A toric lens: Contact lens"
11327864|NCT03418064|OG001|Outcome|Lotrafilcon B Toric Contact Lens 1 Month|"Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study.~lotrafilcon B toric lens: Contact lens"
11327865|NCT03418064|OG000|Outcome|Habitual Toric Lens|Subjects were evaluated at baseline with their habitual toric lenses.
11327866|NCT03418064|EG000|Reported Event|Fanfilcon A Toric|"Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.~Fanfilcon A toric lens: Contact lens"
11327867|NCT03418064|EG001|Reported Event|Lotrafilcon B Toric|"Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.~Lotrafilcon B toric lens: Contact lens"
11327868|NCT03418324|BG000|Baseline|Arm A: TRC105 + Abiraterone|"Patients progressing on Abiraterone will undergo a washout period and then continue treatment with TRC105 + Abiraterone~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Abiraterone: Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105."
11327869|NCT03418324|BG001|Baseline|Arm E: TRC105 + Enzalutamide|"Patients progressing on Enzalutamide will undergo a washout period and then continue treatment with TRC105 + Enzalutamide~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Enzalutamide: Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105."
11327870|NCT03418324|BG002|Baseline|Total|Total of all reporting groups
11327871|NCT03418324|FG000|Participant Flow|Arm A: TRC105 + Abiraterone|"Patients progressing on Abiraterone will undergo a washout period and then continue treatment with TRC105 + Abiraterone~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Abiraterone: Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105."
11327872|NCT03418324|FG001|Participant Flow|Arm E: TRC105 + Enzalutamide|"Patients progressing on Enzalutamide will undergo a washout period and then continue treatment with TRC105 + Enzalutamide~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Enzalutamide: Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105."
10827941|NCT00112437|FG013|Participant Flow|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
10827942|NCT00112437|FG014|Participant Flow|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
11327873|NCT03418324|OG000|Outcome|Arm A: TRC105 + Abiraterone|"Patients progressing on Abiraterone will undergo a washout period and then continue treatment with TRC105 + Abiraterone~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Abiraterone: Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105."
11333775|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact lens : somofilcon A multifocal lens"
11333776|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens: somofilcon A multifocal lens"
11333777|NCT03519919|OG000|Outcome|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~Contact Lens:somofilcon A multifocal lens"
11333778|NCT03519919|OG000|Outcome|Habitual Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment~Contact Lens: Habitual Lens"
11333779|NCT03519919|OG000|Outcome|Overall Participants|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment at the final visit for overall comfort.~Contact Lens: somofilcon A 1-day multifocal Contact Lens: Habitual Lens"
11333780|NCT03519919|OG000|Outcome|Overall Study -Do You Prefer Your Own Lenses or the Study Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment at the final visit for overall preference.~Contact lens - Habitual Lens and somofilcon A contact lens"
11333781|NCT03519919|EG000|Reported Event|Somofilcon A Multifocal Lens|"Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.~somofilcon A multifocal lens: contact lens"
11333782|NCT03519932|BG000|Baseline|Overall Study|Total Participants
11333783|NCT03519932|FG000|Participant Flow|Comfilcon A Toric Then Samfilcon A Toric|"Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month.~Contact Lens: comfilcon A toric Contact Lens: Samfilcon A toric"
11333784|NCT03519932|FG001|Participant Flow|Samfilcon A Toric Then Comfilcon A Toric|"Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month.~Contact Lens: Samfilcon A toric Contact Lens: comfilcon A toric"
11333785|NCT03519932|OG000|Outcome|Comfilcon A Toric Lens|"Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.~comfilcon A toric lens: Contact lens"
11333786|NCT03519932|OG001|Outcome|Samfilcon A Toric Lens|"Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.~samfilcon A toric lens: Contact lens"
11333787|NCT03519932|OG000|Outcome|Overall Preference|"Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month.~comfilcon A toric lens: Contact lens~samfilcon A toric lens: Contact lens"
11333788|NCT03519932|OG000|Outcome|Overall Participants|"Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month.~comfilcon A toric lens: Contact lens~samfilcon A toric lens: Contact lens"
11333789|NCT03519932|OG000|Outcome|Comfilcon A Toric Lens|"Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric during this cross-over study.~comfilcon A toric lens: Contact lens"
11333790|NCT03519932|OG000|Outcome|Comfilcon A Toric Lens|"Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.~comfilcon A toric lens: Contact lens~samfilcon A toric lens: Contact lens"
11333791|NCT03519932|OG001|Outcome|Samfilcon A Toric Lens|"Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.~comfilcon A toric lens: Contact lens~samfilcon A toric lens: Contact lens"
11333792|NCT03519932|EG000|Reported Event|Comfilcon A Toric|"Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.~Contact Lens: comfilcon A toric"
11333793|NCT03519932|EG001|Reported Event|Samfilcon A Toric|"Subjects were randomized to wear samfilcon A toric lenses for 1-month and comfilcon A toric lenses for 1-month in this cross-over dispensing study.~Contact Lens: samfilcon A toric"
11333794|NCT03520283|BG000|Baseline|Enrolled Participants|Baseline characteristics of study participants that actually participated in study interventions.
11333795|NCT03520283|BG001|Baseline|Declined Participants|Baseline characteristics of potential participants that declined participation
11333796|NCT03520283|BG002|Baseline|Total|Total of all reporting groups
11333797|NCT03520283|FG000|Participant Flow|Enrolled Participants|Baseline characteristics of study participants that actually participated in study interventions.
11333798|NCT03520283|FG001|Participant Flow|Declined Participants|Baseline characteristics of potential participants that declined participation
11333799|NCT03520283|OG000|Outcome|Enrollment Rate - Eligible Participants|To be calculated as the percent of eligible participants approached who agree to participate. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
11333800|NCT03520283|OG000|Outcome|Participation Rate - Eligible Participants|To be calculated as the percent of participants who complete the study intervention among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
11333801|NCT03520283|OG000|Outcome|Retention Rate - Eligible Participants|To be calculated as the number of participants who complete the study measures among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
11333802|NCT03520283|OG000|Outcome|Self-reported Ratings of Intervention Acceptability - Eligible Participants|Descriptive statistics will be used to summarize participant ratings of acceptability.
11333803|NCT03520283|OG000|Outcome|Measures of Autonomy Assessed by Index of Autonomous Functioning|Autonomy will be assessed at baseline and at 2 weeks with a difference of the two time points.
11333804|NCT03520283|OG000|Outcome|Self-efficacy for Managing Cancer - Chronic Disease Scale|Self-efficacy for managing cancer will be assessed as a mean value at baseline and at two weeks with a difference of values between the two time points.
11333805|NCT03520283|OG000|Outcome|Self-Efficacy for Managing Symptoms - (PROMIS) Short Form|Self-efficacy for managing cancer will be assessed as a mean value at baseline and at two weeks with a difference of values between the two time points.
11333806|NCT03520283|OG000|Outcome|PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists Patient-Provider Connection|Relatedness to interventionists was measured at 2 weeks after intervention.
11333807|NCT03520283|OG000|Outcome|Psychological Stress Assessed by Perceived Stress Scale - Eligible Participants|Descriptive statistics (means, standard deviations) will be used to summarize proximal outcomes and change in health outcomes by assessment measure. The primary interest will be in estimating the variance for use in planning future studies.
11333808|NCT03520283|OG000|Outcome|Symptoms Assessed by PROMIS Profile 29 - Eligible Participants|Descriptive statistics (means, standard deviations) will be used to summarize proximal outcomes and change in health outcomes by assessment measure. The primary interest will be in estimating the variance for use in planning future studies.
11333809|NCT03520283|OG000|Outcome|Health Behaviors - Tobacco Use|Participants' status of tobacco use will be assessed during at baseline survey.
11333810|NCT03520283|OG000|Outcome|Enrolled Participants|Baseline characteristics of study participants that actually participated in study interventions.
11333811|NCT03520283|EG000|Reported Event|Supportive Care (MAP)|"Participants complete MAP in-clinic over 60-90 minutes.~Interview: Ancillary studies~Questionnaire Administration: Ancillary studies~System Support Mapping: Complete MAP"
11333812|NCT03520348|BG000|Baseline|PRO-167|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom~PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.~Route of administration: ophthalmic"
11333813|NCT03520348|BG001|Baseline|Corneregel®|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.~Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.~Route of administration: ophthalmic"
11333814|NCT03520348|BG002|Baseline|Total|Total of all reporting groups
11333815|NCT03520348|FG000|Participant Flow|PRO-167|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom~PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.~Route of administration: ophthalmic"
11333816|NCT03520348|FG001|Participant Flow|Corneregel®|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.~Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.~Route of administration: ophthalmic"
11333817|NCT03520348|OG000|Outcome|PRO-167|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom~PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.~Route of administration: ophthalmic"
11333818|NCT03520348|OG001|Outcome|Corneregel®|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.~Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.~Route of administration: ophthalmic"
11333819|NCT03520348|EG000|Reported Event|PRO-167|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom~PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.~Route of administration: ophthalmic"
11333820|NCT03520348|EG001|Reported Event|Corneregel®|"Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.~Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.~Route of administration: ophthalmic"
11333821|NCT03520387|BG000|Baseline|Pre-Randomization Run-In Period|The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized. There are no participants in this group after randomization.
11333822|NCT03520387|BG001|Baseline|Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11333823|NCT03520387|BG002|Baseline|Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11095186|NCT01556724|OG001|Outcome|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11095187|NCT01556724|OG001|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11327874|NCT03418324|OG001|Outcome|Arm E: TRC105 + Enzalutamide|"Patients progressing on Enzalutamide will undergo a washout period and then continue treatment with TRC105 + Enzalutamide~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Enzalutamide: Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105."
11327875|NCT03418324|EG000|Reported Event|Arm A: TRC105 + Abiraterone|"Patients progressing on Abiraterone will undergo a washout period and then continue treatment with TRC105 + Abiraterone~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Abiraterone: Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105."
11327876|NCT03418324|EG001|Reported Event|Arm E: TRC105 + Enzalutamide|"Patients progressing on Enzalutamide will undergo a washout period and then continue treatment with TRC105 + Enzalutamide~TRC105: Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks~Enzalutamide: Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105."
11327877|NCT03418376|BG000|Baseline|MS Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327878|NCT03418376|BG001|Baseline|MS Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327879|NCT03418376|BG002|Baseline|HC Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327880|NCT03418376|BG003|Baseline|HC Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327881|NCT03418376|BG004|Baseline|Total|Total of all reporting groups
11327882|NCT03418376|FG000|Participant Flow|MS Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327883|NCT03418376|FG001|Participant Flow|MS Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327884|NCT03418376|FG002|Participant Flow|HC Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327885|NCT03418376|FG003|Participant Flow|HC Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327886|NCT03418376|OG000|Outcome|MS Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327887|NCT03418376|OG001|Outcome|MS Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327888|NCT03418376|OG002|Outcome|HC Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327889|NCT03418376|OG003|Outcome|HC Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327890|NCT03418376|EG000|Reported Event|MS Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327891|NCT03418376|EG001|Reported Event|MS Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11336027|NCT03559933|EG000|Reported Event|Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy|Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
11327892|NCT03418376|EG002|Reported Event|HC Beta-alanine Supplementation|"Subjects will perform a 6-month intervention and receive beta-alanine supplements.~Beta-alanine supplementation: The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100"
11327893|NCT03418376|EG003|Reported Event|HC Placebo Group|"Subjects will perform a 6-month exercise intervention and receive placebo tablets.~Exercise intervention: The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT."
11327894|NCT03418545|BG000|Baseline|No-treatment Control|Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
11327895|NCT03418545|BG001|Baseline|JUVÉDERM® VOLBELLA™ XC|JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
11327896|NCT03418545|BG002|Baseline|Total|Total of all reporting groups
11327897|NCT03418545|FG000|Participant Flow|No-treatment Control|Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
11327898|NCT03418545|FG001|Participant Flow|JUVÉDERM® VOLBELLA™ XC|JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
11327899|NCT03418545|OG000|Outcome|No-treatment Control|Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
11327900|NCT03418545|OG001|Outcome|JUVÉDERM® VOLBELLA™ XC|JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
11327901|NCT03418545|OG000|Outcome|JUVÉDERM® VOLBELLA™ XC|JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined.
11327902|NCT03418545|EG000|Reported Event|No-treatment Control|Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
11327903|NCT03418545|EG001|Reported Event|JUVÉDERM® VOLBELLA™ Initial Treatment|JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator.
11327904|NCT03418545|EG002|Reported Event|JUVÉDERM® VOLBELLA™ Optional Treatment|Participants randomized to the No-treatment Control group received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel, injected into the infraorbital and adjacent area Month 3 after Randomization as determined by the investigator.
11327905|NCT03418545|EG003|Reported Event|JUVÉDERM® VOLBELLA™ Repeat Treatment|Participants randomized to the JUVÉDERM® VOLBELLA™ XC arm received JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area 12 months after the last treatment as determined by the investigator.
11327906|NCT03418571|BG000|Baseline|ALX-0171 1.5 mg/kg|Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
11327907|NCT03418571|BG001|Baseline|Placebo|Single inhalation of placebo once daily for 3 consecutive days.
11327908|NCT03418571|BG002|Baseline|Total|Total of all reporting groups
11327909|NCT03418571|FG000|Participant Flow|ALX-0171 1.5 mg/kg|Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
11327910|NCT03418571|FG001|Participant Flow|Placebo|Single inhalation of placebo once daily for 3 consecutive days.
11327911|NCT03418571|OG000|Outcome|ALX-0171 1.5 mg/kg|Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
11327912|NCT03418571|OG001|Outcome|Placebo|Single inhalation of placebo once daily for 3 consecutive days.
11327913|NCT03418571|EG000|Reported Event|ALX-0171 1.5 mg/kg|Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
11327914|NCT03418571|EG001|Reported Event|Placebo|Single inhalation of placebo once daily for 3 consecutive days.
11327915|NCT03418662|BG000|Baseline|EndoRings Colonoscopy|"Colonoscopy with EndoRings device attached to the distal end of the scope.~EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure."
11327916|NCT03418662|BG001|Baseline|Control Arm (Standard Colonoscopy)|Standard colonoscopy with no device attachment.
11327917|NCT03418662|BG002|Baseline|Total|Total of all reporting groups
11327918|NCT03418662|FG000|Participant Flow|EndoRings Colonoscopy|"Colonoscopy with EndoRings device attached to the distal end of the scope.~EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure."
11327919|NCT03418662|FG001|Participant Flow|Control Arm (Standard Colonoscopy)|Standard colonoscopy with no device attachment.
11327920|NCT03418662|OG000|Outcome|EndoRings Colonoscopy|"Colonoscopy with EndoRings device attached to the distal end of the scope.~EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure."
11327921|NCT03418662|OG001|Outcome|Control Arm (Standard Colonoscopy)|Standard colonoscopy with no device attachment.
11327922|NCT03418662|EG000|Reported Event|EndoRings Colonoscopy|"Colonoscopy with EndoRings device attached to the distal end of the scope.~EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure."
11327923|NCT03418662|EG001|Reported Event|Control Arm (Standard Colonoscopy)|Standard colonoscopy with no device attachment.
11327924|NCT03418714|BG000|Baseline|Salvinorin A Administration|"All volunteers will be assigned to the salvinorin A administration arm.~Salvinorin A: Salvinorin A, blinded doses"
11327925|NCT03418714|FG000|Participant Flow|Salvinorin A Administration|"All volunteers will be assigned to the salvinorin A administration arm.~Salvinorin A: Salvinorin A (15 micrograms/kg, vaporized), blinded doses"
11327926|NCT03418714|OG000|Outcome|Salvinorin A Administration|"All volunteers will be assigned to the salvinorin A administration arm.~Salvinorin A: Salvinorin A, blinded doses"
11327927|NCT03418714|EG000|Reported Event|Salvinorin A Administration|"All volunteers will be assigned to the salvinorin A administration arm.~Salvinorin A: Salvinorin A, blinded doses"
11327928|NCT03419078|BG000|Baseline|Adequate Enteral Nutrition|Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
11327929|NCT03419078|BG001|Baseline|Adequate Parenteral Nutrition|Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
11327930|NCT03419078|BG002|Baseline|Inadequate Nutrition|Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
11327931|NCT03419078|BG003|Baseline|Total|Total of all reporting groups
11327932|NCT03419078|FG000|Participant Flow|Adequate Enteral Nutrition|Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
11327933|NCT03419078|FG001|Participant Flow|Adequate Parenteral Nutrition|Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
11327934|NCT03419078|FG002|Participant Flow|Inadequate Nutrition|Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
11327935|NCT03419078|OG000|Outcome|Adequate Enteral Nutrition|Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
11327936|NCT03419078|OG001|Outcome|Adequate Parenteral Nutrition|Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
11327937|NCT03419078|OG002|Outcome|Inadequate Nutrition|Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
11327938|NCT03419078|EG000|Reported Event|Adequate Enteral Nutrition|Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
11327939|NCT03419078|EG001|Reported Event|Adequate Parenteral Nutrition|Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
11327940|NCT03419078|EG002|Reported Event|Inadequate Nutrition|Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
11327941|NCT03419403|BG000|Baseline|Standard Steroids|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days
11327942|NCT03419403|BG001|Baseline|Standard Steroids + Vasoconstrictor + Cold Compress|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable).
11327943|NCT03419403|BG002|Baseline|Enhanced Steroids + Vasoconstrictor + Cold Compress|Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable).
11327944|NCT03419403|BG003|Baseline|Total|Total of all reporting groups
11327945|NCT03419403|FG000|Participant Flow|Standard Steroids|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days
11327946|NCT03419403|FG001|Participant Flow|Standard Steroids + Vasoconstrictor + Cold Compress|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable).
11327947|NCT03419403|FG002|Participant Flow|Enhanced Steroids + Vasoconstrictor + Cold Compress|Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable).
11327948|NCT03419403|FG003|Participant Flow|Untreated Participants|Participants who were randomized to the study but received no doses of depatuxizumab mafodotin or prophylactic eye treatments
11327949|NCT03419403|OG000|Outcome|Standard Steroids|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days
11327950|NCT03419403|OG001|Outcome|Standard Steroids + Vasoconstrictor + Cold Compress|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable).
11327951|NCT03419403|OG002|Outcome|Enhanced Steroids + Vasoconstrictor + Cold Compress|Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable).
11327952|NCT03419403|EG000|Reported Event|Standard Steroids|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days
11327953|NCT03419403|EG001|Reported Event|Standard Steroids + Vasoconstrictor + Cold Compress|Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable).
11336028|NCT03560102|BG000|Baseline|MR-HIFU Treatment|"Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat& resect model~Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine."
11336029|NCT03560102|FG000|Participant Flow|MR-HIFU Treatment|"Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat& resect model~Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine."
11336030|NCT03560102|OG000|Outcome|MR-HIFU Treatment|"Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat& resect model~Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine."
11336031|NCT03560102|EG000|Reported Event|MR-HIFU Treatment|"Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat& resect model~Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine."
11336032|NCT03560128|BG000|Baseline|AmplifEYE Arm|"Colonoscopy with AmplifEYE device attached to the distal end of the scope.~AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure."
11336033|NCT03560128|BG001|Baseline|Endocuff Vision Arm|"Colonoscopy with Endocuff Vision device attached to the distal end of the scope.~Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure."
11336034|NCT03560128|BG002|Baseline|Total|Total of all reporting groups
11336035|NCT03560128|FG000|Participant Flow|AmplifEYE Arm|"Colonoscopy with AmplifEYE device attached to the distal end of the scope.~AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure."
11336036|NCT03560128|FG001|Participant Flow|Endocuff Vision Arm|"Colonoscopy with Endocuff Vision device attached to the distal end of the scope.~Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure."
11336037|NCT03560128|OG000|Outcome|AmplifEYE Arm|"Colonoscopy with AmplifEYE device attached to the distal end of the scope.~AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure."
11336038|NCT03560128|OG001|Outcome|Endocuff Vision Arm|"Colonoscopy with Endocuff Vision device attached to the distal end of the scope.~Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure."
11336039|NCT03560128|EG000|Reported Event|AmplifEYE Arm|"Colonoscopy with AmplifEYE device attached to the distal end of the scope.~AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure."
11336040|NCT03560128|EG001|Reported Event|Endocuff Vision Arm|"Colonoscopy with Endocuff Vision device attached to the distal end of the scope.~Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure."
11336041|NCT03560141|BG000|Baseline|LID011121 (OD) / Biofinity (OS)|LID011121 contact lens in the right eye, with comfilcon A contact lens in the left eye, as randomized, for one night of extended (overnight) wear
11336042|NCT03560141|BG001|Baseline|Biofinity (OD) / LID011121 (OS)|Comfilcon A contact lens in the right eye, with LID011121 contact lens in the left eye, as randomized, for one night of extended (overnight) wear
11336043|NCT03560141|BG002|Baseline|Total|Total of all reporting groups
11336044|NCT03560141|FG000|Participant Flow|LID011121 (OD) / Biofinity (OS)|LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear
11336045|NCT03560141|FG001|Participant Flow|Biofinity (OD) / LID011121 (OS)|Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear
11336046|NCT03560141|OG000|Outcome|LID011121|LID011121 contact lens worn in the right eye or left eye, as randomized, for one night of extended (overnight) wear
11336047|NCT03560141|OG001|Outcome|Biofinity|Comfilcon A contact lens worn in the right eye or left eye, as randomized, for one night of extended (overnight) wear
11336048|NCT03560141|EG000|Reported Event|Pretreatment|Events reported in this group occurred prior to exposure to the study contact lenses
11336049|NCT03560141|EG001|Reported Event|LID011121 - Ocular|Events reported in this group occurred while exposed to LID011121 contact lenses
11336050|NCT03560141|EG002|Reported Event|Biofinity - Ocular|Events reported in this group occurred while exposed to comfilcon A contact lenses
11336051|NCT03560141|EG003|Reported Event|Nonocular/Systemic|Events reported in this group occurred during exposure to the study contact lenses
11336052|NCT03560245|BG000|Baseline|Bryostatin 20µg|"20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11336053|NCT03560245|BG001|Baseline|Placebo|"Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug"
11336054|NCT03560245|BG002|Baseline|Total|Total of all reporting groups
11336055|NCT03560245|FG000|Participant Flow|Bryostatin 20µg|"20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11336056|NCT03560245|FG001|Participant Flow|Placebo|"Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug"
11336057|NCT03560245|OG000|Outcome|Bryostatin 20µg|"20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11327954|NCT03419403|EG002|Reported Event|Enhanced Steroids + Vasoconstrictor + Cold Compress|Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable).
11327955|NCT03419533|BG000|Baseline|2018 School Leavers|South Australian school leavers in 2018 (year 12 in 2017)
11327956|NCT03419533|BG001|Baseline|2019 School Leavers|South Australian school leavers in 2019 (year 12 in 2018)
11327957|NCT03419533|BG002|Baseline|Total|Total of all reporting groups
11327958|NCT03419533|FG000|Participant Flow|2018 School Leavers|South Australian school leavers in 2018 (year 12 in 2017)
11327959|NCT03419533|FG001|Participant Flow|2019 School Leavers|South Australian school leavers in 2019 (year 12 in 2018)
11327960|NCT03419533|OG000|Outcome|2018 School Leavers|Disease associated genogroups
11327961|NCT03419533|OG001|Outcome|2019 School Leavers|Disease associated genogroups
11327962|NCT03419533|OG000|Outcome|2018 School Leavers|All genogroups
11327963|NCT03419533|OG001|Outcome|2019 School Leavers|All genogroups
11327964|NCT03419533|OG000|Outcome|2018 School Leavers|Each genogroup
11327965|NCT03419533|OG001|Outcome|2019 School Leavers|Each genogroup
11327966|NCT03419533|OG000|Outcome|Vaccinated|4CMenB vaccinated school leavers
11327967|NCT03419533|OG001|Outcome|Unvaccinated|4CMenB unvaccinated school leavers
11327968|NCT03419533|OG000|Outcome|Male|Carriage prevalence of all N. meningitidis genogroups based on gender
11327969|NCT03419533|OG001|Outcome|Female|Carriage prevalence of all N. meningitidis genogroups based on gender
11327970|NCT03419533|EG000|Reported Event|2018 School Leavers|South Australian school leavers in 2018 (year 12 in 2017)
11327971|NCT03419533|EG001|Reported Event|2019 School Leavers|South Australian school leavers in 2019 (year 12 in 2018)
11327972|NCT03419598|BG000|Baseline|All Study Participants|"Opening wedge high tibial osteotomy (HTO): Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia~Cohort duplicated into 2 copies. Copy A. Stabilised by Personalised HTO plate. Copy B. Stabilised by Generic HTO plate."
11327973|NCT03419598|FG000|Participant Flow|All Study Participants|"Opening wedge high tibial osteotomy (HTO).~Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia.~Since this is a virtual trial, the virtual patients were duplicated and had the osteotomy stabilised by a generic HTO plate in one copy of the cohort and by a personalised HTO plate in the other copy."
11327974|NCT03419598|OG000|Outcome|Personalised HTO|"Opening wedge high tibial osteotomy~Personalised subject specific custom HTO plate~Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia~Stabilised by personalised HTO plate, contoured to subject's tibial geometry"
11327975|NCT03419598|OG001|Outcome|Generic HTO|"Opening wedge high tibial osteotomy~Generic HTO plate~Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia~Generic HTO plate: Generic plate for stabilizing an open wedge HTO"
11327976|NCT03419598|OG000|Outcome|Personalised HTO|"Opening wedge high tibial osteotomy~Personalised subject specific custom HTO plate~Opening wedge high tibial osteotomy: Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia~Stabilising by personalised HTO contoured to subject's tibial geometry"
11327977|NCT03419598|EG000|Reported Event|All Study Participants|"Opening wedge high tibial osteotomy (HTO): Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia.~Virtual cohort duplicated into A. stabilised by Personalised HTO plate and B. stabilised by Generic HTO plate."
11327978|NCT03419780|BG000|Baseline|Single-Unit Blood Transfusion Protocol|"In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327979|NCT03419780|BG001|Baseline|Multiple-Unit Blood Transfusion Protocol|"In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327980|NCT03419780|BG002|Baseline|Total|Total of all reporting groups
11327981|NCT03419780|FG000|Participant Flow|Single-Unit Blood Transfusion Protocol|"In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327982|NCT03419780|FG001|Participant Flow|Multiple-Unit Blood Transfusion Protocol|"In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327983|NCT03419780|OG000|Outcome|Single-Unit Blood Transfusion Protocol|"In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327984|NCT03419780|OG001|Outcome|Multiple-Unit Blood Transfusion Protocol|"In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327985|NCT03419780|EG000|Reported Event|Single-Unit Blood Transfusion Protocol|"In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
10827943|NCT00112437|FG015|Participant Flow|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
11327986|NCT03419780|EG001|Reported Event|Multiple-Unit Blood Transfusion Protocol|"In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.~Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion."
11327987|NCT03419962|BG000|Baseline|Spiolto® Respimat® 2.5mg/2.5mg|2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
11327988|NCT03419962|FG000|Participant Flow|Spiolto® Respimat® 2.5mg/2.5mg|2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
11327989|NCT03419962|OG000|Outcome|Spiolto® Respimat® 2.5mg/2.5mg|2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
11327990|NCT03419962|EG000|Reported Event|Spiolto® Respimat® 2.5mg/2.5mg|2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
11327991|NCT03420300|BG000|Baseline|EBR/GZR|"Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks~EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks"
11327992|NCT03420300|FG000|Participant Flow|EBR/GZR|"Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks~EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks"
11327993|NCT03420300|OG000|Outcome|EBR/GZR|"Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks~EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks"
11327994|NCT03420300|EG000|Reported Event|EBR/GZR|"Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks~EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks"
11327995|NCT03420625|BG000|Baseline|Hemodynamic Studies|Patients undergoing different stimulations of venous blood flow.
11327996|NCT03420625|FG000|Participant Flow|Hemodynamic Studies|"Patients undergoing different interventions to promote venous return. Washout (1 hour) in between different interventions. Patients started in different orders with: Foot IPC, Rapid Calf IPC, Slow Calf IPC and Calf NMES."
11327997|NCT03420625|OG000|Outcome|Baseline|Venous blood flow during supine position
11327998|NCT03420625|OG001|Outcome|Foot IPC|"Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA~Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA"
11327999|NCT03420625|OG002|Outcome|Rapid Calf IPC|"Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA~Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA"
11328000|NCT03420625|OG003|Outcome|Slow Calf IPC|"Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA~Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA"
11328001|NCT03420625|OG004|Outcome|Calf NMES|"Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator~Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator"
11328002|NCT03420625|OG000|Outcome|Baseline|Blood flow during supine position
11328003|NCT03420625|OG000|Outcome|Foot IPC|"Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA~Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA"
11328004|NCT03420625|OG001|Outcome|Rapid Calf IPC|"Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA~Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA"
11328005|NCT03420625|OG002|Outcome|Slow Calf IPC|"Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA~Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA"
11328006|NCT03420625|OG003|Outcome|Calf NMES|"Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator~Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator"
11328007|NCT03420625|EG000|Reported Event|Foot IPC|Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
11328008|NCT03420625|EG001|Reported Event|Rapid Calf IPC|Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
11328009|NCT03420625|EG002|Reported Event|Slow Calf IPC|Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
11328010|NCT03420625|EG003|Reported Event|Calf NMES|Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
11333824|NCT03520387|BG003|Baseline|Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11336058|NCT03560245|OG001|Outcome|Placebo|"Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug"
10827944|NCT00112437|FG016|Participant Flow|Odanacatib 25 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
11328011|NCT03421210|BG000|Baseline|Nicotine Replacement Therapy|"Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.~Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment."
11328012|NCT03421210|FG000|Participant Flow|Nicotine Replacement Therapy|"Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.~Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment."
11328013|NCT03421210|OG000|Outcome|Nicotine Replacement Therapy|"Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.~Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment."
11328014|NCT03421210|EG000|Reported Event|Nicotine Replacement Therapy|"Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.~Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment."
11328015|NCT03421379|BG000|Baseline|Glucagon Nasal Powder/Glucagon Hydrochloride Solution|A single dose of 3 mg glucagon nasal powder was administered intranasally
11328016|NCT03421379|BG001|Baseline|Glucagon Hydrochloride Solution/Glucagon Nasal Powder|A single dose of 1 mg glucagon hydrochloride solution was administered IM
11328017|NCT03421379|BG002|Baseline|Total|Total of all reporting groups
11328018|NCT03421379|FG000|Participant Flow|Glucagon Nasal Powder/Glucagon Hydrochloride|A single dose of 3 milligram (mg) glucagon nasal powder was administered intranasally in period 1 then 1 mg single dose intramuscular glucagon hydrochloride solution was administered in period 2.
11328019|NCT03421379|FG001|Participant Flow|Glucagon Hydrochloride Solution/Glucagon Nasal Powder|A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM) in period 1 then 3 mg single dose glucagon nasal powder was administered in period 2.
11328020|NCT03421379|OG000|Outcome|Glucagon Nasal Powder|A single dose of 3 mg glucagon nasal powder was administered intranasally
11328021|NCT03421379|OG001|Outcome|Glucagon Hydrochloride Solution|A single dose of 1 mg glucagon hydrochloride solution was administered IM
11328022|NCT03421379|EG000|Reported Event|Glucagon Nasal Powder|A single dose of 3 mg glucagon nasal powder was administered intranasally
11328023|NCT03421379|EG001|Reported Event|Glucagon Hydrochloride Solution|A single dose of 1 mg glucagon hydrochloride solution was administered IM
11328024|NCT03421431|BG000|Baseline|Placebo|A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.
11328025|NCT03421431|BG001|Baseline|EDP-305 1 mg|EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328026|NCT03421431|BG002|Baseline|EDP-305 2.5 mg|EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328027|NCT03421431|BG003|Baseline|Total|Total of all reporting groups
11328028|NCT03421431|FG000|Participant Flow|Placebo|A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.
11328029|NCT03421431|FG001|Participant Flow|EDP-305 1 mg|EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328030|NCT03421431|FG002|Participant Flow|EDP-305 2.5 mg|EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328031|NCT03421431|OG000|Outcome|Placebo|A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.
11328032|NCT03421431|OG001|Outcome|EDP-305 1 mg|EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328033|NCT03421431|OG002|Outcome|EDP-305 2.5 mg|EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328034|NCT03421431|OG000|Outcome|EDP-305 1 mg|EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328035|NCT03421431|OG001|Outcome|EDP-305 2.5 mg|EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328036|NCT03421431|EG000|Reported Event|Placebo|A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.
11328037|NCT03421431|EG001|Reported Event|EDP-305 1 mg|EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328038|NCT03421431|EG002|Reported Event|EDP-305 2.5 mg|EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
11328039|NCT03421730|BG000|Baseline|Overall Treatment|Baseline measures were not analysed by arm or comparison group, so they are presented for the total number of subjects enrolled in the study who received at least one dose of treatment.
11328040|NCT03421730|FG000|Participant Flow|AB - VR647 5 Breaths, Then VR647 10 Breaths|5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A) followed by 10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B)
10827945|NCT00112437|FG017|Participant Flow|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
11095188|NCT01556724|OG000|Outcome|0.2% Ropivacaine Nerve Block (Standard of Care)|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuo
11095189|NCT01556724|OG001|Outcome|0.1% Ropivacaine Infusion in Nerve Block Catheter|0.1% or 0.2% ropivacaine nerve blocks: Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters w
11095190|NCT01556724|EG000|Reported Event|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11095191|NCT01556724|EG001|Reported Event|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
11095192|NCT01556763|BG000|Baseline|Placebo|Matching placebo was administered as one capsule per day for 21 days.
11095193|NCT01556763|BG001|Baseline|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
11095194|NCT01556763|BG002|Baseline|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
11095195|NCT01556763|BG003|Baseline|Total|Total of all reporting groups
11095196|NCT01556763|FG000|Participant Flow|Placebo|Matching placebo was administered as one capsule per day for 21 days.
11095197|NCT01556763|FG001|Participant Flow|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
11095198|NCT01556763|FG002|Participant Flow|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
11095199|NCT01556763|OG000|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
11095200|NCT01556763|OG001|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
11095201|NCT01556763|OG002|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
11095202|NCT01556763|OG000|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
11095203|NCT01556763|OG001|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
11095204|NCT01556763|EG000|Reported Event|Placebo|Matching placebo was administered as one capsule per day for 21 days.
11095205|NCT01556763|EG001|Reported Event|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
11095206|NCT01556763|EG002|Reported Event|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
11095207|NCT01556906|BG000|Baseline|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
11095208|NCT01556906|FG000|Participant Flow|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
11095209|NCT01556906|OG000|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
11095210|NCT01556906|EG000|Reported Event|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
11328041|NCT03421730|FG001|Participant Flow|AC - VR647 5 Breaths, Then VR647 20 Breaths|5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A) followed by 20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C)
11328042|NCT03421730|FG002|Participant Flow|AD - VR647 5 Breaths, Then Pulmicort|5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A) followed by 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D)
11328043|NCT03421730|FG003|Participant Flow|BA - VR647 10 Breaths, Then VR647 5 Breaths|10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B) followed by 5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A)
11328044|NCT03421730|FG004|Participant Flow|BC - VR647 10 Breaths, Then VR647 20 Breaths|10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B) followed by 20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C)
11328045|NCT03421730|FG005|Participant Flow|BD - VR647 10 Breaths, Then Pulmicort|10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B) followed by 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D)
11328046|NCT03421730|FG006|Participant Flow|CA - VR647 20 Breaths, Then VR647 5 Breaths|20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C) followed by 5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A)
11328047|NCT03421730|FG007|Participant Flow|CB - VR647 20 Breaths, Then VR647 10 Breaths|20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C) followed by 10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B)
11328048|NCT03421730|FG008|Participant Flow|CD - VR647 20 Breaths, Then Pulmicort|20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C) followed by 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D)
11328049|NCT03421730|FG009|Participant Flow|DA - Pulmicort, Then VR647 5 Breaths|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D) followed by 5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (A)
11328050|NCT03421730|FG010|Participant Flow|DB - Pulmicort, Then VR647 10 Breaths|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D) followed by 10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (B)
11328051|NCT03421730|FG011|Participant Flow|DC - Pulmicort, Then VR647 20 Breaths|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty (D) followed by 20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (C)
11328052|NCT03421730|OG000|Outcome|A - 5 Breaths VR647|"5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
11328053|NCT03421730|OG001|Outcome|B - 10 Breaths VR647|"10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
11328054|NCT03421730|OG002|Outcome|C - 20 Breaths VR647|"20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
11328055|NCT03421730|OG003|Outcome|D - Pulmicort|"1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty~1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer: Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering."
11328056|NCT03421730|OG000|Outcome|A - 5 Breaths VR647|5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.
11328057|NCT03421730|OG001|Outcome|B - 10 Breaths VR647|10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.
11328058|NCT03421730|OG002|Outcome|C - 20 Breaths VR647|20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.
11328059|NCT03421730|EG000|Reported Event|A - 5 Breaths VR647|"5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
11328060|NCT03421730|EG001|Reported Event|B - 10 Breaths VR647|"10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
11328061|NCT03421730|EG002|Reported Event|C - 20 Breaths VR647|"20 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System~VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System: The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial."
10827946|NCT00112437|FG018|Participant Flow|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
11328062|NCT03421730|EG003|Reported Event|D - Pulmicort|"1 mg/2 mL Pulmicort Respules delivered by the conventional jet nebulizer nebulized to empty~1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer: Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering."
11328063|NCT03421730|EG004|Reported Event|Overall Treatment|The total number of subjects enrolled in the study who received at least one dose of treatment.
11328064|NCT03421886|BG000|Baseline|Aerodentis System|"28 patients was systematically assigned to the treatment group (wearing Aerodentis Device) due to 2 run-in fails.~Aerodentis system: The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient."
11328065|NCT03421886|BG001|Baseline|Invisalign Clear Aligner System|"15 patients was systematically assigned to the control group (wearing clear aligners).~Invisalign clear aligner system: Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result."
11328066|NCT03421886|BG002|Baseline|Total|Total of all reporting groups
11328067|NCT03421886|FG000|Participant Flow|Aerodentis System|"30 patients was systematically assigned to the treatment group (wearing Aerodentis Device).~Aerodentis system: The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient."
11328068|NCT03421886|FG001|Participant Flow|Invisalign Clear Aligner System|"15 patients was systematically assigned to the control group (wearing clear aligners).~Invisalign clear aligner system: Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result."
11328069|NCT03421886|OG000|Outcome|Aerodentis System|"30 patients was systematically assigned to the treatment group (wearing Aerodentis Device).~Aerodentis system: The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient."
11328070|NCT03421886|OG001|Outcome|Invisalign Clear Aligner System|"15 patients was systematically assigned to the control group (wearing clear aligners).~Invisalign clear aligner system: Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result."
11328071|NCT03421886|EG000|Reported Event|Aerodentis System|"30 patients was systematically assigned to the treatment group (wearing Aerodentis Device).~Aerodentis system: The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient."
11328072|NCT03421886|EG001|Reported Event|Invisalign Clear Aligner System|"15 patients was systematically assigned to the control group (wearing clear aligners).~Invisalign clear aligner system: Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result."
11328073|NCT03422159|BG000|Baseline|Treatment|"Based on published clinical data, vitamin C pharmacokinetic modeling, the package insert as well as the preliminary study by Marik et al, Vitamin C will be administered as an intravenous dose of 6gm per day divided in 4 equal doses. This dosage is reported to be devoid of any complications or side effects. Hydrocortisone will be dosed according to the consensus guidelines of the American College of Critical Care Medicine. Thiamine will be administered according to current recommendations in a dose of 200mg q 12 hourly. This will be continued for 4 days, or less if discharged from the ICU prior.~Ascorbic Acid: Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).~Thiamine: Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).~Hydrocortisone: Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328074|NCT03422159|BG001|Baseline|Comparator|"Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled Vitamin C or Placebo. Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled Thiamine 200mg or Placebo and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.~Sodium Chloride 0.9%: Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328075|NCT03422159|BG002|Baseline|Total|Total of all reporting groups
11328076|NCT03422159|FG000|Participant Flow|Treatment Arm|"Based on published clinical data, vitamin C pharmacokinetic modeling, the package insert as well as the preliminary study by Marik et al, Vitamin C will be administered as an intravenous dose of 6gm per day divided in 4 equal doses. This dosage is reported to be devoid of any complications or side effects. Hydrocortisone will be dosed according to the consensus guidelines of the American College of Critical Care Medicine. Thiamine will be administered according to current recommendations in a dose of 200mg q 12 hourly. This will be continued for 4 days, or less if discharged from the ICU prior.~Ascorbic Acid: Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).~Thiamine: Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).~Hydrocortisone: Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328077|NCT03422159|FG001|Participant Flow|Placebo Arm|"Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled Vitamin C or Placebo. Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled Thiamine 200mg or Placebo and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.~Sodium Chloride 0.9%: Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328078|NCT03422159|OG000|Outcome|HAT Treatment|Receiving Hydrocortisone, Ascorbic Acid, and Thiamine
11328079|NCT03422159|OG001|Outcome|Comparator|Receiving placebo
11328080|NCT03422159|OG000|Outcome|Treatment Arm|"Based on published clinical data, vitamin C pharmacokinetic modeling, the package insert as well as the preliminary study by Marik et al, Vitamin C will be administered as an intravenous dose of 6gm per day divided in 4 equal doses. This dosage is reported to be devoid of any complications or side effects. Hydrocortisone will be dosed according to the consensus guidelines of the American College of Critical Care Medicine. Thiamine will be administered according to current recommendations in a dose of 200mg q 12 hourly. This will be continued for 4 days, or less if discharged from the ICU prior.~Ascorbic Acid: Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).~Thiamine: Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).~Hydrocortisone: Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328081|NCT03422159|OG001|Outcome|Placebo Arm|"Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled Vitamin C or Placebo. Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled Thiamine 200mg or Placebo and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.~Sodium Chloride 0.9%: Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328082|NCT03422159|EG000|Reported Event|Treatment Arm|"Based on published clinical data, vitamin C pharmacokinetic modeling, the package insert as well as the preliminary study by Marik et al, Vitamin C will be administered as an intravenous dose of 6gm per day divided in 4 equal doses. This dosage is reported to be devoid of any complications or side effects. Hydrocortisone will be dosed according to the consensus guidelines of the American College of Critical Care Medicine. Thiamine will be administered according to current recommendations in a dose of 200mg q 12 hourly. This will be continued for 4 days, or less if discharged from the ICU prior.~Ascorbic Acid: Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).~Thiamine: Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).~Hydrocortisone: Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328083|NCT03422159|EG001|Reported Event|Placebo Arm|"Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled Vitamin C or Placebo. Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled Thiamine 200mg or Placebo and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.~Sodium Chloride 0.9%: Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
11328084|NCT03422172|BG000|Baseline|Cabotegravir|Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
11328085|NCT03422172|FG000|Participant Flow|Cabotegravir|Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
11328086|NCT03422172|OG000|Outcome|CAB LA 600 mg (Injection Phase)|Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
11328087|NCT03422172|OG000|Outcome|CAB 30 mg (Oral lead-in Phase)|Participants received 30 mg Cabotegravir tablet once daily orally for 4 weeks during oral lead-in phase.
11328088|NCT03422172|OG000|Outcome|CAB LA 600 mg (Injection Phase and Long-term Follow up)|Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase followed by a long term follow up from Week 41 to 89.
11328089|NCT03422172|OG000|Outcome|Cabotegravir|Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
11328090|NCT03422172|EG000|Reported Event|CAB 30 mg - Oral lead-in Phase|Participants received 30 mg Cabotegravir tablet once daily orally for 4 weeks during oral lead-in phase.
11328091|NCT03422172|EG001|Reported Event|CAB LA 600 mg - Injection Phase|Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
11328092|NCT03422172|EG002|Reported Event|CAB LA 600 mg - Long-term Follow-up Phase|After Injection phase, participants were followed-up till Week 89 (long-term follow-up phase).
11328093|NCT03422250|BG000|Baseline|AD: Anodal tDCS of the DMN|"AD: anodal tDCS of the default mode (DMN) network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328094|NCT03422250|BG001|Baseline|AD: Cathodal tDCS of the SN|"AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328095|NCT03422250|BG002|Baseline|bvFTD: Anodal tDCS of the SN|"bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328096|NCT03422250|BG003|Baseline|bvFTD: Cathodal tDCS of the DMN|"bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328097|NCT03422250|BG004|Baseline|Total|Total of all reporting groups
11328098|NCT03422250|FG000|Participant Flow|AD: Anodal tDCS of the DMN|"Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328099|NCT03422250|FG001|Participant Flow|AD: Cathodal tDCS of the SN|"Alzheimer's disease (AD): cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328100|NCT03422250|FG002|Participant Flow|bvFTD: Anodal tDCS of the SN|"Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328101|NCT03422250|FG003|Participant Flow|bvFTD: Cathodal tDCS of the DMN|"Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328102|NCT03422250|OG000|Outcome|AD: Anodal tDCS of the DMN|"AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328103|NCT03422250|OG001|Outcome|AD: Cathodal tDCS of the SN|"AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328104|NCT03422250|OG002|Outcome|bvFTD: Anodal tDCS of the SN|"bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328105|NCT03422250|OG003|Outcome|bvFTD: Cathodal tDCS of the DMN|"bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328106|NCT03422250|OG000|Outcome|bvFTD: Anodal tDCS of the SN|"bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328107|NCT03422250|OG001|Outcome|bvFTD: Cathodal tDCS of the DMN|"bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328108|NCT03422250|EG000|Reported Event|AD: Anodal tDCS of the DMN|"AD: anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11328109|NCT03422250|EG001|Reported Event|AD: Cathodal tDCS of the SN|"AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328110|NCT03422250|EG002|Reported Event|bvFTD: Anodal tDCS of the SN|"bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: prefrontal cortex"
11328111|NCT03422250|EG003|Reported Event|bvFTD: Cathodal tDCS of the DMN|"bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.~Stimulation target: inferior parietal cortex"
11095211|NCT01556932|BG000|Baseline|All Participants|"All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.~Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.~Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol."
11095212|NCT01556932|FG000|Participant Flow|ABH Gel- Placebo|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
11095213|NCT01556932|FG001|Participant Flow|Placebo-ABH Gel|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.
11095214|NCT01556932|OG000|Outcome|ABH Gel|ABH Gel applied topically for 2 minutes.
11095215|NCT01556932|OG001|Outcome|Placebo|Placebo applied topically for 2 minutes.
11095216|NCT01556932|EG000|Reported Event|Arm A and Arm B|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically over 2 minutes.
11095217|NCT01556997|BG000|Baseline|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
11095218|NCT01556997|BG001|Baseline|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
11095219|NCT01556997|BG002|Baseline|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
11095220|NCT01556997|BG003|Baseline|Total|Total of all reporting groups
11095221|NCT01556997|FG000|Participant Flow|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
11095222|NCT01556997|FG001|Participant Flow|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
11095223|NCT01556997|FG002|Participant Flow|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
11095224|NCT01556997|OG000|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
11095225|NCT01556997|OG001|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
11095226|NCT01556997|OG002|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
11095227|NCT01556997|EG000|Reported Event|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
11095228|NCT01556997|EG001|Reported Event|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
11095229|NCT01556997|EG002|Reported Event|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
11218024|NCT02318602|OG000|Outcome|Infants|"Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11328112|NCT03423082|BG000|Baseline|18F Fluciclovine PET Scan|"Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.~18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning~18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner"
11095230|NCT01557166|BG000|Baseline|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
11095231|NCT01557166|BG001|Baseline|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
11095232|NCT01557166|BG002|Baseline|Total|Total of all reporting groups
10827947|NCT00112437|FG019|Participant Flow|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
10827948|NCT00112437|FG020|Participant Flow|Placebo Once Weekly-Ext 3|During this 24-month extension (Years 4-5), participants in this treatment group received one placebo tablet once a week.
10827949|NCT00112437|FG021|Participant Flow|Odanacatib 50 mg Once Weekly-Ext 3|During this 24-month extension (Years 4-5), participants in this treatment group received one odanacatib 50 mg tablet once a week.
10827950|NCT00112437|FG022|Participant Flow|Group A: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group A consisted of a combination of participants who were treated with odanacatib 25 mg for 2 years,then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
10843011|NCT00251589|BG000|Baseline|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
10843012|NCT00251589|BG001|Baseline|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10827951|NCT00112437|FG023|Participant Flow|Group B: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group B consisted of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
10827952|NCT00112437|FG024|Participant Flow|Group C: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group C consisted of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
11095233|NCT01557166|FG000|Participant Flow|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
11095234|NCT01557166|FG001|Participant Flow|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
10843013|NCT00251589|BG002|Baseline|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
11095235|NCT01557166|OG000|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
10848568|NCT00290472|OG001|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
11095236|NCT01557166|OG001|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
10843014|NCT00251589|BG003|Baseline|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
10843015|NCT00251589|BG004|Baseline|Total|Total of all reporting groups
11328113|NCT03423082|FG000|Participant Flow|18F Fluciclovine PET Scan|"Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.~18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning~18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner"
11328114|NCT03423082|OG000|Outcome|18F Fluciclovine PET Scan|"Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.~18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning~18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner"
11328115|NCT03423082|EG000|Reported Event|18F Fluciclovine PET Scan|"Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.~18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning~18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner"
11328116|NCT03423173|BG000|Baseline|Placebo|TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
11328117|NCT03423173|BG001|Baseline|TDV Lot 1|Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328118|NCT03423173|BG002|Baseline|TDV Lot 2|Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328119|NCT03423173|BG003|Baseline|TDV Lot 3|Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.
11328120|NCT03423173|BG004|Baseline|Total|Total of all reporting groups
11328121|NCT03423173|FG000|Participant Flow|Placebo|TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
11328122|NCT03423173|FG001|Participant Flow|TDV Lot 1|Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328123|NCT03423173|FG002|Participant Flow|TDV Lot 2|Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328124|NCT03423173|FG003|Participant Flow|TDV Lot 3|Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.
11328125|NCT03423173|OG000|Outcome|Placebo|TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
11328126|NCT03423173|OG001|Outcome|TDV Lot 1|Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328127|NCT03423173|OG002|Outcome|TDV Lot 2|Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328128|NCT03423173|OG003|Outcome|TDV Lot 3|Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.
11328129|NCT03423173|EG000|Reported Event|Placebo|TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
11328130|NCT03423173|EG001|Reported Event|TDV Lot 1|Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328131|NCT03423173|EG002|Reported Event|TDV Lot 2|Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
11328132|NCT03423173|EG003|Reported Event|TDV Lot 3|Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.
11328133|NCT03423186|BG000|Baseline|Dose Group 1|"SOBI003 dose 3 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328134|NCT03423186|BG001|Baseline|Dose Group 2|"SOBI003 dose 10 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328135|NCT03423186|BG002|Baseline|Total|Total of all reporting groups
11328136|NCT03423186|FG000|Participant Flow|Dose Group 1|"SOBI003 dose 3 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328137|NCT03423186|FG001|Participant Flow|Dose Group 2|"SOBI003 dose 10 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328138|NCT03423186|OG000|Outcome|Dose Group 1|"SOBI003 dose 3 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328139|NCT03423186|OG001|Outcome|Dose Group 2|"SOBI003 dose 10 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328140|NCT03423186|EG000|Reported Event|Dose Group 1|"SOBI003 dose 3 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328141|NCT03423186|EG001|Reported Event|Dose Group 2|"SOBI003 dose 10 mg/kg once weekly for 24 weeks~SOBI003: Weekly i.v.infusion"
11328142|NCT03423238|BG000|Baseline|Rehab Only|Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
11328143|NCT03423238|BG001|Baseline|Rehab+Weight Loss (WL)|Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
11328144|NCT03423238|BG002|Baseline|Total|Total of all reporting groups
11328145|NCT03423238|FG000|Participant Flow|Rehab Only|Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
11095237|NCT01557166|EG000|Reported Event|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
10843016|NCT00251589|FG000|Participant Flow|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
10843017|NCT00251589|FG001|Participant Flow|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10843018|NCT00251589|FG002|Participant Flow|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10827953|NCT00112437|FG025|Participant Flow|Group D: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet once a week. Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
10827954|NCT00112437|OG000|Outcome|Placebo-Base|One placebo tablet once a week
10827955|NCT00112437|OG001|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
10827956|NCT00112437|OG002|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
10827957|NCT00112437|OG003|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
10827958|NCT00112437|OG004|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
10827959|NCT00112437|OG000|Outcome|Placebo-Ext 1|One placebo tablet once a week
10827960|NCT00112437|OG001|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
11328146|NCT03423238|FG001|Participant Flow|Rehab+Weight Loss (WL)|Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
11328147|NCT03423238|OG000|Outcome|All Participants|Includes all eligible participants prior to randomization
11328148|NCT03423238|OG000|Outcome|Rehab Only|Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
11328149|NCT03423238|OG001|Outcome|Rehab+Weight Loss (WL)|Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
11328150|NCT03423238|EG000|Reported Event|Rehab Only|Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
11328151|NCT03423238|EG001|Reported Event|Rehab+Weight Loss (WL)|Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
11328152|NCT03423641|BG000|Baseline|Direct Acting Antivirals|"Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.~Direct Acting Antivirals: The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication."
11328153|NCT03423641|BG001|Baseline|Comparison|The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)
11328154|NCT03423641|BG002|Baseline|Total|Total of all reporting groups
11328155|NCT03423641|FG000|Participant Flow|Direct Acting Antivirals|"Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.~Direct Acting Antivirals: The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication."
11328156|NCT03423641|FG001|Participant Flow|Comparison|The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)
11328157|NCT03423641|OG000|Outcome|Direct Acting Antivirals|"Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.~Direct Acting Antivirals: The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication."
11328158|NCT03423641|OG001|Outcome|Comparison|The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)
11328159|NCT03423641|EG000|Reported Event|Direct Acting Antivirals|"Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.~Direct Acting Antivirals: The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication."
11328160|NCT03423641|EG001|Reported Event|Comparison|The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)
11328161|NCT03424044|BG000|Baseline|All Study Participants|All study participants were randomized to complete three 76 hour study visits using either dual hormone, single hormone or predictive low glucose suspend closed loop control. Treatment order was randomized
11328162|NCT03424044|FG000|Participant Flow|PLGS-SH-DH|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), single hormone (SH) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
11328163|NCT03424044|FG001|Participant Flow|DH-PLGS-SH|The randomization order for subjects in this arm was dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
11328164|NCT03424044|FG002|Participant Flow|SH-DH-PLGS|The randomization order for subjects in this arm was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
11328165|NCT03424044|FG003|Participant Flow|SH-PLGS-DH|The randomization order for subjects in this arm was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 76 hours and included inpatient and outpatient portions.
11328166|NCT03424044|FG004|Participant Flow|DH-SH-PLGS|The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 76 hours and included inpatient and outpatient portions.
11328167|NCT03424044|FG005|Participant Flow|PLGS-DH-SH|The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 76 hours and included inpatient and outpatient portions.
11328168|NCT03424044|FG006|Participant Flow|SH-SH-DH|The randomization order for this subject was single hormone (SH), dual hormone (DH) and predictive low glucose suspend (PLGS). The first SH visit wasn't completed due to technical issues and was repeated before continuing to the DH arm, which was not completed. Each visit was 76 hours and included inpatient and outpatient portions.
10827961|NCT00112437|OG002|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
10827962|NCT00112437|OG003|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
10827963|NCT00112437|OG004|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
10827964|NCT00112437|OG000|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
11328169|NCT03424044|FG007|Participant Flow|SH-SH-PLGS-DH|The randomization order for this subject was single hormone (SH), predictive low glucose suspend (PLGS) and dual hormone (DH). Due to device issues, the first SH study was not completed. A second SH study was completed before continuing to PLGS and DH arms. Each arm was 76 hours and included inpatient and outpatient portions.
11328170|NCT03424044|FG008|Participant Flow|DH-DH-PLGS-SH|The randomization order for this subject was dual hormone (DH), predictive low glucose suspend (PLGS) and single hormone (SH). Due to device issues, the first DH study was not completed. A second DH study was completed before continuing to PLGS and SH arms. Each arm was 76 hours and included inpatient and outpatient portions.
11328171|NCT03424044|OG000|Outcome|Dual Hormone Closed-loop Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.~Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.~XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode."
11328172|NCT03424044|OG001|Outcome|Single Hormone Closed-loop Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.~Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component."
11328173|NCT03424044|OG002|Outcome|Predictive Low Glucose Suspend Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.~Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component."
11328174|NCT03424044|OG000|Outcome|Dual Hormone Closed Loop|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.~Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.~XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode."
11328175|NCT03424044|EG000|Reported Event|Dual Hormone Closed-loop Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.~Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component.~XeriSol glucagon: XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode."
11328176|NCT03424044|EG001|Reported Event|Single Hormone Closed-loop Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient.~Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component."
11328177|NCT03424044|EG002|Reported Event|Predictive Low Glucose Suspend Arm|"Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient. The system will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run but the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.~Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component."
11328178|NCT03424044|EG003|Reported Event|Dexcom Training Period Arm|Subjects used the Dexcom G6 CGM along with the APC app. Subjects attended a training visit on using the Dexcom G6. Subjects used the G6 at home over the next 7 days.
11328179|NCT03424187|BG000|Baseline|Experimental: Whole Chickpea First, Then Flour Chickpea, Then Intact Cell Chickpea|First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Flour chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell Chickpea hummus (26g carbohydrate)
11328180|NCT03424187|BG001|Baseline|Experimental: Whole Chickpea First, Then Intact Cell Chickpea, Then Flour Chickpea|First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate
11328181|NCT03424187|BG002|Baseline|Experimental:Flour Chickpea First, Then Whole Chickpea, Then Intact Chickpea|First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell hummus (26g carbohydrate)
11328182|NCT03424187|BG003|Baseline|Experimental: Flour Chickpea First, Intact Cell Chickpea, Whole Chickpea|First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
11328183|NCT03424187|BG004|Baseline|Experimental: Intact Cell Chickpea First, Then Whole Chickpea, Then Flour Chickpea|First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
11328184|NCT03424187|BG005|Baseline|Experimental: Intact Cell Chickpea First, Then Flour Chickpea, Then Whole Chickpea|First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second flour Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
11328185|NCT03424187|BG006|Baseline|Total|Total of all reporting groups
11328186|NCT03424187|FG000|Participant Flow|Experimental: Whole Chickpea First, Then Flour Chickpea, Then Intact Cell Chickpea|First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Flour chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell Chickpea hummus (26g carbohydrate)
10827965|NCT00112437|OG001|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
10827966|NCT00112437|OG002|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
10827967|NCT00112437|OG003|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
10827968|NCT00112437|OG004|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
10827969|NCT00112437|OG005|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
11328187|NCT03424187|FG001|Participant Flow|Experimental: Whole Chickpea First, Then Intact Cell Chickpea, Then Flour Chickpea|First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
11328188|NCT03424187|FG002|Participant Flow|Experimental:Flour Chickpea First, Then Whole Chickpea, Then Intact Chickpea|First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell hummus (26g carbohydrate)
11328189|NCT03424187|FG003|Participant Flow|Experimental: Flour Chickpea First, Intact Cell Chickpea, Whole Chickpea|First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
11328190|NCT03424187|FG004|Participant Flow|Experimental: Intact Cell Chickpea First, Then Whole Chickpea, Then Flour Chickpea|First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
11328191|NCT03424187|FG005|Participant Flow|Experimental: Intact Cell Chickpea First, Then Flour Chickpea, Then Whole Chickpea|First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second flour Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
11328192|NCT03424187|OG000|Outcome|Whole Chickpea|"a test meal containing 26g available carbohydrates from chickpea (full structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328193|NCT03424187|OG001|Outcome|Flour Chickpea|"a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328194|NCT03424187|OG000|Outcome|Whole Chickpea Hummus|"a test meal containing 26g available carbohydrates from chickpea (full structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328195|NCT03424187|OG001|Outcome|Flour Chickpea Hummus|"a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328196|NCT03424187|OG002|Outcome|Intact Cell Chickpea Hummus|"a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328197|NCT03424187|OG000|Outcome|Whole Chickpea Hummus|a test meal containing 26g available carbohydrates from chickpea (full structure)
11328198|NCT03424187|OG001|Outcome|Flour Chickpea Hummus|a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
11328199|NCT03424187|OG002|Outcome|Intact Cell Chickpea Hummus|a test meal containing 26g available carbohydrates from Intact cell chickpea (destroyed structure)
11328200|NCT03424187|EG000|Reported Event|Whole Chickpea|"a test meal containing 26g available carbohydrates from chickpea (full structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328201|NCT03424187|EG001|Reported Event|Flour Chickpea|"a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328202|NCT03424187|EG002|Reported Event|Intact Cell Chickpea|"a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)~chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):~• Whole chickpea, flour chickpea, intact cell flour chickpea"
11328203|NCT03424239|BG000|Baseline|Drug: Zoledronic Acid, Calcium+Vitamin D|"Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.~Zoledronic Acid: 5mg zoledronic acid~Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3~Vitamin D3: 1000IU Vitamin D3 gummy"
11328204|NCT03424239|FG000|Participant Flow|Drug: Zoledronic Acid, Calcium+Vitamin D|"Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.~Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid~Zoledronic Acid: 5mg zoledronic acid~Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3~Vitamin D3: 1000IU Vitamin D3 gummy"
11328205|NCT03424239|OG000|Outcome|Drug: Zoledronic Acid, Calcium+Vitamin D|"Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.~Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid~Zoledronic Acid: 5mg zoledronic acid~Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3~Vitamin D3: 1000IU Vitamin D3 gummy"
11336059|NCT03560245|OG000|Outcome|Bryostatin 20µg|Subjects were scheduled to receive seven doses over 12 weeks. The first two doses of study drug were to be a loading dose 20% higher (i.e., 24µg) than the assigned dose and were to be administered one week apart. Thereafter, the assigned dose of 20µg was to commence with the third dose and be administered every other week. The study drug was administered intravenously (IV) by continuous infusion over 45(±5) minutes.
11336060|NCT03560245|OG001|Outcome|Placebo|Subjects were scheduled to receive seven doses over 12 weeks. The study drug was administered intravenously (IV) by continuous infusion over 45(±5) minutes.
11336061|NCT03560245|EG000|Reported Event|Bryostatin 20µg|"20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.~Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution."
11095238|NCT01557166|EG001|Reported Event|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
10827970|NCT00112437|OG006|Outcome|Odanacatib 25 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
11095239|NCT01557244|BG000|Baseline|Cohort 1: Fesoterodine 4 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.
10827971|NCT00112437|OG007|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
10827972|NCT00112437|OG008|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
10827973|NCT00112437|OG009|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
10827974|NCT00112437|OG006|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
11095240|NCT01557244|BG001|Baseline|Cohort 1: Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.
11095241|NCT01557244|BG002|Baseline|Cohort 1: Oxybutynin|Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.
10827975|NCT00112437|OG007|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
10827976|NCT00112437|OG006|Outcome|Odanacatib 25 mg / Placebo 50 Mg-Ext 2|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year."
10827977|NCT00112437|OG000|Outcome|Placebo Once Weekly|One placebo tablet once a week
10827978|NCT00112437|OG001|Outcome|Odanacatib 50 mg Once Weekly|One odanacatib 50 mg tablet once a week
11328206|NCT03424239|EG000|Reported Event|Drug: Zoledronic Acid, Calcium+Vitamin D|"Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.~Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid~Zoledronic Acid: 5mg zoledronic acid~Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3~Vitamin D3: 1000IU Vitamin D3 gummy"
11328207|NCT03424265|BG000|Baseline|9g of EAA Mixture Supplement|"Twice a day for 12 consecutive weeks.~EAA mixture: Dietary supplement intervention for 12-weeks"
11328208|NCT03424265|BG001|Baseline|9g of Placebo (Whey Protein)|"Twice a day for 12 consecutive weeks.~Placebo (whey protein): Dietary supplement intervention for 12-weeks"
11328209|NCT03424265|BG002|Baseline|Total|Total of all reporting groups
11328210|NCT03424265|FG000|Participant Flow|9g of EAA Mixture Supplement|"Twice a day for 12 consecutive weeks.~EAA mixture: Dietary supplement intervention for 12-weeks"
11328211|NCT03424265|FG001|Participant Flow|9g of Placebo (Whey Protein)|"Twice a day for 12 consecutive weeks.~Placebo (whey protein): Dietary supplement intervention for 12-weeks"
11328212|NCT03424265|OG000|Outcome|9g of EAA Mixture Supplement|"Twice a day for 12 consecutive weeks.~EAA mixture: Dietary supplement intervention for 12-weeks"
10827979|NCT00112437|OG000|Outcome|Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
11328213|NCT03424265|OG001|Outcome|9g of Placebo (Whey Protein)|"Twice a day for 12 consecutive weeks.~Placebo (whey protein): Dietary supplement intervention for 12-weeks"
11328214|NCT03424265|EG000|Reported Event|9g of EAA Mixture Supplement|"Twice a day for 12 consecutive weeks.~EAA mixture: Dietary supplement intervention for 12-weeks"
11328215|NCT03424265|EG001|Reported Event|9g of Placebo (Whey Protein)|"Twice a day for 12 consecutive weeks.~Placebo (whey protein): Dietary supplement intervention for 12-weeks"
11328216|NCT03424681|BG000|Baseline|Modafinil|"Modafinil 300 mg by mouth each day~Modafinil: Modafinil 300 mg by mouth daily"
11328217|NCT03424681|BG001|Baseline|Placebo|"Identical looking capsule/number of capsules by mouth each day without active medication~Placebo: Placebo"
11328218|NCT03424681|BG002|Baseline|Total|Total of all reporting groups
11328219|NCT03424681|FG000|Participant Flow|Modafinil|"Modafinil 300 mg by mouth each day~Modafinil: Modafinil 300 mg by mouth daily"
11328220|NCT03424681|FG001|Participant Flow|Placebo|"Identical looking capsule/number of capsules by mouth each day without active medication~Placebo: Placebo"
11328221|NCT03424681|OG000|Outcome|Modafinil|"Modafinil 300 mg by mouth each day~Modafinil: Modafinil 300 mg by mouth daily"
11328222|NCT03424681|OG001|Outcome|Placebo|"Identical looking capsule/number of capsules by mouth each day without active medication~Placebo: Placebo"
11328223|NCT03424681|EG000|Reported Event|Modafinil|"Modafinil 300 mg by mouth each day~Modafinil: Modafinil 300 mg by mouth daily"
11328224|NCT03424681|EG001|Reported Event|Placebo|"Identical looking capsule/number of capsules by mouth each day without active medication~Placebo: Placebo"
11328225|NCT03425019|BG000|Baseline|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
11328226|NCT03425019|FG000|Participant Flow|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
11328227|NCT03425019|OG000|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
11328228|NCT03425019|OG000|Outcome|Transcranial Direct Current Stimulation|"Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.~Soterix 1x1 tDCS mini-CT Stimulator device: Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff."
11328229|NCT03425019|EG000|Reported Event|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
11328230|NCT03425097|BG000|Baseline|All Participants|Patients in this group will get 2 weeks of fexofenadine (180 mg) or matching placebo, then 1 week of nothing, then 2 weeks of the opposite treatment.
11328231|NCT03425097|FG000|Participant Flow|Fexofenadine Then Placebo|Patients in this group will get 2 weeks of fexofenadine (180 mg), then 1 week of nothing, then 2 weeks of placebo.
11328232|NCT03425097|FG001|Participant Flow|Placebo Then Fexofenadine|Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine (180 mg)
11328233|NCT03425097|OG000|Outcome|Run-in Period|Participants entered a 1 week run-in period prior to randomization.
11328234|NCT03425097|OG001|Outcome|Fexofenadine|Fexofenadine (180 mg) for 2 weeks
11328235|NCT03425097|OG002|Outcome|Placebo|Fexofenadine placebo for 2 weeks
11328236|NCT03425097|OG000|Outcome|Fexofenadine|Fexofenadine (180 mg) for 2 weeks
11328237|NCT03425097|OG001|Outcome|Placebo|Fexofenadine placebo for 2 weeks
11328238|NCT03425097|EG000|Reported Event|Fexofenadine|Fexofenadine (180 mg) for 2 weeks
11328239|NCT03425097|EG001|Reported Event|Placebo|Fexofenadine placebo for 2 weeks
11328240|NCT03425188|BG000|Baseline|Treatment|Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
11328241|NCT03425188|FG000|Participant Flow|Treatment|Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study. This is a subset of the 151 subjects enrolled in the original pivotal trial of the remede System.
11328242|NCT03425188|OG000|Outcome|Enrolled in Pivotal Trial|All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
11328243|NCT03425188|OG000|Outcome|Treatment|Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
11328244|NCT03425188|EG000|Reported Event|Treatment|Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
11328245|NCT03425253|BG000|Baseline|BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine|BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
11328246|NCT03425253|FG000|Participant Flow|BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine|BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
11328247|NCT03425253|OG000|Outcome|BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine|BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
11328248|NCT03425253|OG000|Outcome|BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine|BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).
11328249|NCT03425253|EG000|Reported Event|BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine|BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
11328250|NCT03425396|BG000|Baseline|Omadacycline 300/300 Once Every 24 Hours|Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328251|NCT03425396|BG001|Baseline|Omadacycline 450/300 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328252|NCT03425396|BG002|Baseline|Omadacycline 450/450 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
10827980|NCT00112437|OG001|Outcome|Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
10827981|NCT00112437|OG002|Outcome|Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
11095242|NCT01557244|BG003|Baseline|Cohort 2: Fesoterodine 2 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.
10827982|NCT00112437|OG003|Outcome|Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
10827983|NCT00112437|OG001|Outcome|Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years
10827984|NCT00112437|EG000|Reported Event|Years 1-2 Placebo/Placebo-Ext 1|One placebo tablet once a week
10827985|NCT00112437|EG001|Reported Event|Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
10827986|NCT00112437|EG002|Reported Event|Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
10827987|NCT00112437|EG003|Reported Event|Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
10827988|NCT00112437|EG004|Reported Event|Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
10827989|NCT00112437|EG005|Reported Event|Year 3 Placebo/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
10827990|NCT00112437|EG006|Reported Event|Year 3 Placebo/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
10827991|NCT00112437|EG007|Reported Event|Year 3 Odanacatib 3 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
10827992|NCT00112437|EG008|Reported Event|Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
10827993|NCT00112437|EG009|Reported Event|Year 3 Odanacatib 10 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
10827994|NCT00112437|EG010|Reported Event|Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
10827995|NCT00112437|EG011|Reported Event|Year 3 Odanacatib 25 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
10827996|NCT00112437|EG012|Reported Event|Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
10827997|NCT00112437|EG013|Reported Event|Year 3 Odanacatib 50 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
10827998|NCT00112437|EG014|Reported Event|Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
10827999|NCT00112437|EG015|Reported Event|Years 4-5 Combined Group A.1: Odanacatib 50 mg|"Combined Group A.1 consists of participants who received odanacatib 50 mg once a week during Year 3.~During this 24-month extension (Years 4-5), these participants continued to receive odanacatib 50 mg once a week."
10828000|NCT00112437|EG016|Reported Event|Years 4-5 Combined Group A.2: Odanacatib 50 mg|Combined Group A.2 consists of participants who received placebo or odanacatib 3 mg in Years 1, 2 and 3. During this 24-month extension (Years 4-5), these participants received odanacatib 50 mg once a week.
10828001|NCT00112437|EG017|Reported Event|Years 4-5 Combined Group A.3: Placebo|Combined Group A.3 consists of participants who, during this 24-month extension (Years 4-5), received placebo once a week.
10828002|NCT00112437|EG018|Reported Event|Years 6-10 Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
10828003|NCT00112437|EG019|Reported Event|Years 6-10 Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
10828004|NCT00112437|EG020|Reported Event|Years 6-10 Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years
10828005|NCT00112437|EG021|Reported Event|Years 6-10 Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
10828006|NCT00112463|BG000|Baseline|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
10828007|NCT00112463|FG000|Participant Flow|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
10828008|NCT00112463|OG000|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
10828009|NCT00112463|OG000|Outcome|Treatment (Single-agent Depsipeptide)|"Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.~romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting."
10828010|NCT00112463|EG000|Reported Event|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
10828011|NCT00112489|BG000|Baseline|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
10828012|NCT00112489|FG000|Participant Flow|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
10828013|NCT00112489|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE
10828014|NCT00112489|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10828015|NCT00112489|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10828016|NCT00112489|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10828017|NCT00112489|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10828018|NCT00112489|OG005|Outcome|Grade 5 (CTCAE v.3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10828019|NCT00112489|OG000|Outcome|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
10828020|NCT00112489|EG000|Reported Event|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
10828021|NCT00112502|BG000|Baseline|Arm I: TMZ|Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
10828022|NCT00112502|BG001|Baseline|Arm II: TMZ + Thalidomide|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828023|NCT00112502|BG002|Baseline|Arm III: TMZ + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828024|NCT00112502|BG003|Baseline|Arm IV: TMZ + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828025|NCT00112502|BG004|Baseline|Arm V: TMZ + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828026|NCT00112502|BG005|Baseline|Arm VI: TMZ + Thalidomide + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828027|NCT00112502|BG006|Baseline|Arm VII: TMZ + Thalidomide + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828028|NCT00112502|BG007|Baseline|Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828029|NCT00112502|BG008|Baseline|Total|Total of all reporting groups
10828030|NCT00112502|FG000|Participant Flow|Arm I: TMZ|Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
10828031|NCT00112502|FG001|Participant Flow|Arm II: TMZ + Thalidomide|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828032|NCT00112502|FG002|Participant Flow|Arm III: TMZ + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828033|NCT00112502|FG003|Participant Flow|Arm IV: TMZ + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828034|NCT00112502|FG004|Participant Flow|Arm V: TMZ + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828035|NCT00112502|FG005|Participant Flow|Arm VI: TMZ + Thalidomide + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828036|NCT00112502|FG006|Participant Flow|Arm VII: TMZ + Thalidomide + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828037|NCT00112502|FG007|Participant Flow|Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828038|NCT00112502|OG000|Outcome|Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII|"Arm II: TMZ + Thalidomide, Arm VI: TMZ + Thalidomide + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828039|NCT00112502|OG001|Outcome|No Thalidomide: Arm I, Arm III, Arm IV and Arm V|"Arm I: TMZ, Arm III: TMZ + Celecoxib, Arm IV: TMZ + Isotretinoin and Arm V: TMZ + Isotretinoin + Celecoxib~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828040|NCT00112502|OG000|Outcome|Celecoxib: Arm III, Arm V, Arm VI and Arm VIII|"Arm III: TMZ + Celecoxib, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828041|NCT00112502|OG001|Outcome|No Celecoxib: Arm I, Arm II, Arm IV and Arm VII|"Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm IV: TMZ + Isotretinoin and Arm VII: TMZ + Thalidomide + Isotretinoin.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828042|NCT00112502|OG000|Outcome|Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII|"Arm IV: TMZ + Isotretinoin, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828043|NCT00112502|OG001|Outcome|No Isotretinoin: Arm I, Arm II, Arm III and Arm VI|"Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm VI: TMZ + Thalidomide + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828044|NCT00112502|OG000|Outcome|Doublet (2 Agents): Arm II, Arm III and Arm IV|"Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm IV: TMZ + Isotretinoin~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828045|NCT00112502|OG001|Outcome|Triplet (3 Agents): Arm V, Arm VI and Arm VII|"Arm V: TMZ + Isotretinoin + Celecoxib, Arm VI: TMZ + Thalidomide + Celecoxib and Arm VII: Thalidomide + Celecoxib + Isotretinoin~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828046|NCT00112502|OG000|Outcome|Arm I: TMZ|Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
10828047|NCT00112502|OG001|Outcome|Arm II: TMZ + Thalidomide|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828048|NCT00112502|OG002|Outcome|Arm III: TMZ + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828049|NCT00112502|OG003|Outcome|Arm IV: TMZ + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828050|NCT00112502|OG004|Outcome|Arm V: TMZ + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828051|NCT00112502|OG005|Outcome|Arm VI: TMZ + Thalidomide + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828052|NCT00112502|OG006|Outcome|Arm VII: TMZ + Thalidomide + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828053|NCT00112502|OG007|Outcome|Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828054|NCT00112502|OG000|Outcome|Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII|"Arm IV: TMZ + Isotretinoin, Arm V: TMZ + Isotretinoin + Celecoxib, Arm VII: TMZ + Thalidomide + Isotretinoin and Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828055|NCT00112502|OG001|Outcome|No Isotretinoin: Arm I, Arm II, Arm III and ARM VI|"Arm I: TMZ, Arm II: TMZ + Thalidomide, Arm III: TMZ + Celecoxib and Arm VI: TMZ + Thalidomide + Celecoxib~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved).~Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828056|NCT00112502|EG000|Reported Event|Arm I: TMZ|Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.
10828057|NCT00112502|EG001|Reported Event|Arm II: TMZ + Thalidomide|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828058|NCT00112502|EG002|Reported Event|Arm III: TMZ + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing."
10828059|NCT00112502|EG003|Reported Event|Arm IV: TMZ + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828060|NCT00112502|EG004|Reported Event|Arm V: TMZ + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle."
10828061|NCT00112502|EG005|Reported Event|Arm VI: TMZ + Thalidomide + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828062|NCT00112502|EG006|Reported Event|Arm VII: TMZ + Thalidomide + Isotretinoin|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828063|NCT00112502|EG007|Reported Event|Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib|"Oral Temozolomide (TMZ): 150 mg/m^2 once daily on days 1-7 and 15-21.~Celecoxib: 400 mg orally twice a day continuous dosing.~Isotretinoin: 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.~Thalidomide: 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)."
10828064|NCT00112580|BG000|Baseline|Locally Advanced Cohort|Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828065|NCT00112580|BG001|Baseline|Metastatic Cohort|Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828066|NCT00112580|BG002|Baseline|Total|Total of all reporting groups
10828067|NCT00112580|FG000|Participant Flow|Locally Advanced Cohort|Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828068|NCT00112580|FG001|Participant Flow|Metastatic Cohort|Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828069|NCT00112580|OG000|Outcome|Locally Advanced Cohort|Participants with locally advanced pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828070|NCT00112580|OG001|Outcome|Metastatic Cohort|Participants with metastatic pancreatic adenocarcinoma. Treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828071|NCT00112580|EG000|Reported Event|Ipilimumab 3 mg/Kg|Participants with locally advanced or metastatic pancreatic adenocarcinoma treated with Ipilimumab administered at 3 mg/Kg dose every 3 weeks.
10828072|NCT00112593|BG000|Baseline|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
10828073|NCT00112593|FG000|Participant Flow|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
10828074|NCT00112593|OG000|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
10828075|NCT00112593|EG000|Reported Event|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
10828076|NCT00112671|BG000|Baseline|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10828077|NCT00112671|FG000|Participant Flow|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10828078|NCT00112671|OG000|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10828079|NCT00112671|EG000|Reported Event|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
10828080|NCT00112723|BG000|Baseline|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828081|NCT00112723|FG000|Participant Flow|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828082|NCT00112723|FG001|Participant Flow|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828083|NCT00112723|FG002|Participant Flow|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828084|NCT00112723|OG000|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
10828085|NCT00112723|OG001|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
10828086|NCT00112723|OG002|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
10828087|NCT00112723|OG000|Outcome|Dose Level 1 (30+30)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828088|NCT00112723|OG001|Outcome|Level 2 (30+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
10828089|NCT00112723|OG002|Outcome|Level 3 (50+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
10828090|NCT00112723|OG000|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
10828091|NCT00112723|OG001|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
10828092|NCT00112723|OG002|Outcome|Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
10828093|NCT00112723|OG000|Outcome|Dose Levels 1, 2, 3|"Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2)~PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828094|NCT00112723|OG000|Outcome|Cohort 1|Patients diagnosed with Indolent B-cell NHL
10828095|NCT00112723|OG001|Outcome|Cohort 2|Patients diagnosed with Mantle Cell NHL
10828096|NCT00112723|OG002|Outcome|Cohort 4|Patients diagnosed with T Cell NHL
10828097|NCT00112723|OG000|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828098|NCT00112723|OG000|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828099|NCT00112723|OG000|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828100|NCT00112723|OG001|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828101|NCT00112723|OG002|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
10828102|NCT00112723|EG000|Reported Event|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
10828103|NCT00112736|BG000|Baseline|Phase I n=9|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
10828104|NCT00112736|BG001|Baseline|Phase II n=16|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Anaplastic Glioma~erlotinib: Given orally~temsirolimus: Given IV"
10828105|NCT00112736|BG002|Baseline|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
10828106|NCT00112736|BG003|Baseline|Total|Total of all reporting groups
10828107|NCT00112736|FG000|Participant Flow|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
10828108|NCT00112736|FG001|Participant Flow|Phase II (Erlotinib & Temsirolimus)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
10828109|NCT00112736|OG000|Outcome|Phase I - Dose Escalation|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity.~Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts"
10828110|NCT00112736|OG000|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
10828111|NCT00112736|OG001|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
10828112|NCT00112736|OG002|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
10828113|NCT00112736|OG000|Outcome|Phase I 15mg Temsirolimus (MTD Dose)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
10828114|NCT00112736|OG000|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
10828115|NCT00112736|OG002|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
10828116|NCT00112736|OG000|Outcome|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
10828117|NCT00112736|EG000|Reported Event|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
10828118|NCT00112736|EG001|Reported Event|Phase II (Erlotinib & Erlotinib)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
10828119|NCT00112827|BG000|Baseline|Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828120|NCT00112827|BG001|Baseline|Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828121|NCT00112827|BG002|Baseline|Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828122|NCT00112827|BG003|Baseline|Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828123|NCT00112827|BG004|Baseline|Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828124|NCT00112827|BG005|Baseline|Total|Total of all reporting groups
10828125|NCT00112827|FG000|Participant Flow|Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828126|NCT00112827|FG001|Participant Flow|Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828127|NCT00112827|FG002|Participant Flow|Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828128|NCT00112827|FG003|Participant Flow|Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828129|NCT00112827|FG004|Participant Flow|Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828130|NCT00112827|OG000|Outcome|Treatment Arm|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828131|NCT00112827|OG000|Outcome|Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828132|NCT00112827|OG001|Outcome|Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828133|NCT00112827|OG002|Outcome|Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828134|NCT00112827|OG003|Outcome|Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828135|NCT00112827|OG004|Outcome|Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828136|NCT00112827|EG000|Reported Event|Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828137|NCT00112827|EG001|Reported Event|Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10843019|NCT00251589|FG003|Participant Flow|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
10843020|NCT00251589|OG000|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
10828138|NCT00112827|EG002|Reported Event|Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828139|NCT00112827|EG003|Reported Event|Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828140|NCT00112827|EG004|Reported Event|Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)|"See Detailed Description~total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy~melphalan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~filgrastim: Given IV~fluorescence in situ hybridization: Correlative studies~cytogenetic analysis: Correlative studies~cyclophosphamide: Given IV~autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation~lenalidomide: Given orally"
10828141|NCT00112866|BG000|Baseline|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose 500mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828142|NCT00112866|BG001|Baseline|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose 2000mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828143|NCT00112866|BG002|Baseline|Total|Total of all reporting groups
10828144|NCT00112866|FG000|Participant Flow|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose cilengitide 500mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide 2000mg IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828145|NCT00112866|FG001|Participant Flow|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose cilengitide 2000mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828146|NCT00112866|OG000|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~pharmacological study: Correlative studies"
10828147|NCT00112866|OG000|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
10828148|NCT00112866|OG001|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
10828149|NCT00112866|OG001|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
10828150|NCT00112866|OG000|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
10828151|NCT00112866|OG001|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
10843021|NCT00251589|OG001|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10828152|NCT00112866|OG000|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive 2000mg high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828153|NCT00112866|OG001|Outcome|Group II High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828154|NCT00112866|OG000|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828155|NCT00112866|OG001|Outcome|Group II (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828156|NCT00112866|OG000|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828157|NCT00112866|EG000|Reported Event|Post-Operative 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
10828158|NCT00112905|BG000|Baseline|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
10828159|NCT00112905|FG000|Participant Flow|TCC (Transitional Cell Carcinoma) Cohort|Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.
10828160|NCT00112905|OG000|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
10828161|NCT00112905|EG000|Reported Event|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
10828162|NCT00112918|BG000|Baseline|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
10843022|NCT00251589|OG002|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10843023|NCT00251589|OG003|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
10828163|NCT00112918|BG001|Baseline|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828164|NCT00112918|BG002|Baseline|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828165|NCT00112918|BG003|Baseline|Total|Total of all reporting groups
10828166|NCT00112918|FG000|Participant Flow|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
10828167|NCT00112918|FG001|Participant Flow|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828168|NCT00112918|FG002|Participant Flow|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828169|NCT00112918|OG000|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
10828170|NCT00112918|OG001|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828171|NCT00112918|OG002|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828172|NCT00112918|EG000|Reported Event|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
10843024|NCT00251589|EG000|Reported Event|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
10828173|NCT00112918|EG001|Reported Event|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828174|NCT00112918|EG002|Reported Event|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
10828175|NCT00112957|BG000|Baseline|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
10828176|NCT00112957|FG000|Participant Flow|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
10828177|NCT00112957|OG000|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
10828178|NCT00112957|EG000|Reported Event|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
10828179|NCT00113022|BG000|Baseline|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828180|NCT00113022|BG001|Baseline|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828181|NCT00113022|BG002|Baseline|Total|Total of all reporting groups
10828182|NCT00113022|FG000|Participant Flow|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828183|NCT00113022|FG001|Participant Flow|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828184|NCT00113022|OG000|Outcome|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828185|NCT00113022|OG001|Outcome|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828186|NCT00113022|EG000|Reported Event|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828187|NCT00113022|EG001|Reported Event|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
10828188|NCT00113087|BG000|Baseline|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
10828189|NCT00113087|BG001|Baseline|Placebo|Placebo suspension
10828190|NCT00113087|BG002|Baseline|Total|Total of all reporting groups
10828191|NCT00113087|FG000|Participant Flow|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
10828192|NCT00113087|FG001|Participant Flow|Placebo|Placebo suspension
10828193|NCT00113087|OG000|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
10828194|NCT00113087|OG001|Outcome|Placebo|Placebo suspension
10828195|NCT00113087|EG000|Reported Event|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
10828196|NCT00113087|EG001|Reported Event|Placebo|Placebo suspension
10828197|NCT00113217|BG000|Baseline|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
10828198|NCT00113217|FG000|Participant Flow|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
10828199|NCT00113217|OG000|Outcome|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
10828200|NCT00113217|EG000|Reported Event|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
10828201|NCT00113230|BG000|Baseline|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
10828202|NCT00113230|FG000|Participant Flow|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
10828203|NCT00113230|OG000|Outcome|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
10828204|NCT00113230|EG000|Reported Event|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
10828205|NCT00113269|BG000|Baseline|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828206|NCT00113269|BG001|Baseline|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828207|NCT00113269|BG002|Baseline|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828208|NCT00113269|BG003|Baseline|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828209|NCT00113269|BG004|Baseline|Total|Total of all reporting groups
10828210|NCT00113269|FG000|Participant Flow|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828211|NCT00113269|FG001|Participant Flow|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828212|NCT00113269|FG002|Participant Flow|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828213|NCT00113269|FG003|Participant Flow|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828214|NCT00113269|OG000|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828215|NCT00113269|OG001|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828216|NCT00113269|OG002|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828217|NCT00113269|OG003|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828218|NCT00113269|EG000|Reported Event|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828219|NCT00113269|EG001|Reported Event|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
10828220|NCT00113269|EG002|Reported Event|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828221|NCT00113269|EG003|Reported Event|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
10828222|NCT00113295|BG000|Baseline|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
10828223|NCT00113295|BG001|Baseline|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
10828224|NCT00113295|BG002|Baseline|Total|Total of all reporting groups
10828225|NCT00113295|FG000|Participant Flow|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
10828226|NCT00113295|FG001|Participant Flow|Placebo Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
10828227|NCT00113295|OG000|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
10828228|NCT00113295|OG001|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
10828229|NCT00113295|OG000|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
10828230|NCT00113295|EG000|Reported Event|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
10828231|NCT00113295|EG001|Reported Event|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
10828232|NCT00113295|EG002|Reported Event|Paroxetine|Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
10828233|NCT00113321|BG000|Baseline|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
10828234|NCT00113321|FG000|Participant Flow|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
10828235|NCT00113321|OG000|Outcome|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
10828236|NCT00113321|EG000|Reported Event|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
10828237|NCT00113334|BG000|Baseline|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
10828238|NCT00113334|FG000|Participant Flow|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
10828239|NCT00113334|OG000|Outcome|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
10828240|NCT00113334|EG000|Reported Event|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
10828241|NCT00113360|BG000|Baseline|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
10828242|NCT00113360|FG000|Participant Flow|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
10828243|NCT00113360|OG000|Outcome|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
10828244|NCT00113360|EG000|Reported Event|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
10828245|NCT00113373|BG000|Baseline|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10828246|NCT00113373|FG000|Participant Flow|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10828247|NCT00113373|OG000|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10828248|NCT00113373|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10828249|NCT00113373|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10828250|NCT00113373|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10828251|NCT00113373|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10828252|NCT00113373|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10828253|NCT00113373|EG000|Reported Event|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
10842641|NCT00248638|OG000|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
10843025|NCT00251589|EG001|Reported Event|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10843026|NCT00251589|EG002|Reported Event|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
10828254|NCT00113425|BG000|Baseline|Treated Group Pulsed Dye Laser Therapy and Untreated Group|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
10828255|NCT00113425|FG000|Participant Flow|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
10828256|NCT00113425|OG000|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
10828257|NCT00113425|EG000|Reported Event|Treated Group Pulsed Dye Laser Therapy|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
10828258|NCT00113425|EG001|Reported Event|Untreated Group Control|The contralateral side of the face remained untreated, thus serving as an internal control.
10828259|NCT00113490|BG000|Baseline|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828260|NCT00113490|BG001|Baseline|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828261|NCT00113490|BG002|Baseline|Total|Total of all reporting groups
10828262|NCT00113490|FG000|Participant Flow|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828263|NCT00113490|FG001|Participant Flow|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828264|NCT00113490|OG000|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828265|NCT00113490|OG001|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828266|NCT00113490|EG000|Reported Event|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828267|NCT00113490|EG001|Reported Event|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
10828268|NCT00113516|BG000|Baseline|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
10828269|NCT00113516|FG000|Participant Flow|Carboplatin Plus Paclitaxel|Carboplatin Plus Paclitaxel 172-225 mg/m2
10828270|NCT00113516|FG001|Participant Flow|Sunitinib|Sunitinib 50 mg
10828271|NCT00113516|OG000|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
10828272|NCT00113516|OG000|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
10828273|NCT00113516|EG000|Reported Event|Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)|
10828274|NCT00113516|EG001|Reported Event|Sunitinib 50 mg (Part 2)|
10828275|NCT00113529|BG000|Baseline|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
10828276|NCT00113529|FG000|Participant Flow|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
10828277|NCT00113529|OG000|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
10828278|NCT00113529|EG000|Reported Event|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
10828279|NCT00113555|BG000|Baseline|Experimental|Open Label Study
10828280|NCT00113555|FG000|Participant Flow|ACT Adjustable Continence Therapy for Women|Open Label Study, patients implanted with ACT device for treatment of Stress Urinary Incontinence
10828281|NCT00113555|OG000|Outcome|Experimental|Open Label Study
10828282|NCT00113555|OG000|Outcome|ACT Adjustable Continence Therapy for Women|Open Label Study, patients implanted with ACT device for treatment of SUI
10828283|NCT00113555|EG000|Reported Event|ACT Adjustable Continence Therapy for Women|Open Label Study, Patients implanted with ACT device
10828284|NCT00113568|BG000|Baseline|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10828285|NCT00113568|FG000|Participant Flow|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10828286|NCT00113568|OG000|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10828287|NCT00113568|EG000|Reported Event|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
10828288|NCT00113607|BG000|Baseline|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
10828289|NCT00113607|BG001|Baseline|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
10828290|NCT00113607|BG002|Baseline|Total|Total of all reporting groups
10828291|NCT00113607|FG000|Participant Flow|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
10828292|NCT00113607|FG001|Participant Flow|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
10828293|NCT00113607|OG000|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
10828294|NCT00113607|OG001|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
10828295|NCT00113607|OG000|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
10828296|NCT00113607|EG000|Reported Event|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
10828297|NCT00113607|EG001|Reported Event|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
10828298|NCT00113763|BG000|Baseline|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
10828299|NCT00113763|BG001|Baseline|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
10828300|NCT00113763|BG002|Baseline|Total|Total of all reporting groups
10828301|NCT00113763|FG000|Participant Flow|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
10828302|NCT00113763|FG001|Participant Flow|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
10828303|NCT00113763|OG000|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
10828304|NCT00113763|OG001|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
10828305|NCT00113763|OG000|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
10828306|NCT00113763|EG000|Reported Event|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
10828307|NCT00113763|EG001|Reported Event|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
10828308|NCT00113841|BG000|Baseline|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
10828309|NCT00113841|BG001|Baseline|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
10828310|NCT00113841|BG002|Baseline|Total|Total of all reporting groups
10828311|NCT00113841|FG000|Participant Flow|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
10828312|NCT00113841|FG001|Participant Flow|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
10828313|NCT00113841|OG000|Outcome|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
10828314|NCT00113841|OG001|Outcome|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
10828315|NCT00113841|EG000|Reported Event|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
10828316|NCT00113841|EG001|Reported Event|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
10828317|NCT00113880|BG000|Baseline|FluMist Recipients|"Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, risk periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to reference observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21."
10828318|NCT00113880|BG001|Baseline|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
10828319|NCT00113880|BG002|Baseline|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828320|NCT00113880|BG003|Baseline|Total|Total of all reporting groups
10828321|NCT00113880|FG000|Participant Flow|FluMist Recipients|"Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, risk periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to reference observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21."
10828322|NCT00113880|FG001|Participant Flow|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
10828323|NCT00113880|FG002|Participant Flow|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828324|NCT00113880|OG000|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
10828325|NCT00113880|OG001|Outcome|Within Cohort Control|"FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, risk periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to reference observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21."
10828326|NCT00113880|OG002|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
10828327|NCT00113880|OG003|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828328|NCT00113880|OG003|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828329|NCT00113880|OG001|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828330|NCT00113880|OG001|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
10828331|NCT00113880|OG002|Outcome|Unvaccinated Controls|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
10828332|NCT00113880|OG001|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
10828333|NCT00113880|OG000|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
10828334|NCT00113880|OG001|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
10828335|NCT00113880|OG002|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
10828336|NCT00113880|EG000|Reported Event|FluMist Recipients|
10828337|NCT00114114|BG000|Baseline|Group 1: 0 g/Day|Zoladex plus Placebo T gel
10828338|NCT00114114|BG001|Baseline|Group 2: 1.25 g/Day|Zoladex plus 1.25 g/day T gel
10828339|NCT00114114|BG002|Baseline|Group 3: 2.5 g/Day|Zoladex plus 2.5 g/day T gel
10828340|NCT00114114|BG003|Baseline|Group 4: 5 g/Day|Zoladex plus 5 g/day T gel
10828341|NCT00114114|BG004|Baseline|Group 5: 10* g/Day|Zoladex plus 10* g/day T gel; *Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial
10828342|NCT00114114|BG005|Baseline|Group 6: PBO/PBO|Placebo Zoladex plus Placebo T gel
10828343|NCT00114114|BG006|Baseline|Total|Total of all reporting groups
10828344|NCT00114114|FG000|Participant Flow|Group 1: 0 Grams/Day|Zoladex plus Placebo T gel
10828345|NCT00114114|FG001|Participant Flow|Group 2: 1.25 g/Day|Zoladex plus 1.25 g/day T gel
10828346|NCT00114114|FG002|Participant Flow|Group 3: 2.5 g/Day|Zoladex plus 2.5 g/day T gel
10828347|NCT00114114|FG003|Participant Flow|Group 4: 5 g/Day|Zoladex plus 5 g/day T gel
10828348|NCT00114114|FG004|Participant Flow|Group 5: 10* g/Day|Zoladex plus 10 g/day T gel; *Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial
10828349|NCT00114114|FG005|Participant Flow|Group 6: PBO/PBO|Placebo Zoladex plus Placebo T gel
10828350|NCT00114114|OG000|Outcome|Group 1: 0 g/Day|Zoladex plus Placebo Testosterone (T) gel
10828351|NCT00114114|OG001|Outcome|Group 2: 1.25 g/Day|Zoladex plus 1.25 g/day T gel
10828352|NCT00114114|OG002|Outcome|Group 3: 2.5 g/Day|Zoladex plus 2.5 g/day T gel
10828353|NCT00114114|OG003|Outcome|Group 4: 5 g/Day|Zoladex plus 5 g/day T gel
10828354|NCT00114114|OG004|Outcome|Group 5: 10* g/Day|Zoladex plus 10 g/day T gel; *Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial
10828355|NCT00114114|OG005|Outcome|Group 6: Placebo/Placebo (PBO/PBO)|Placebo Zoladex plus Placebo T gel
10828356|NCT00114114|OG000|Outcome|Group 1: 0 g/Day|Zoladex plus Placebo T gel
10828357|NCT00114114|OG005|Outcome|Group 6: PBO/PBO|Placebo Zoladex plus Placebo T gel
10828358|NCT00114114|EG000|Reported Event|Group 1: 0 g/Day|Zoladex plus Placebo T gel
10828359|NCT00114114|EG001|Reported Event|Group 2: 1.25 g/Day|Zoladex plus 1.25 g/day T gel
10828360|NCT00114114|EG002|Reported Event|Group 3: 2.5 g/Day|Zoladex plus 2.5 g/day T gel
10828361|NCT00114114|EG003|Reported Event|Group 4: 5 g/Day|Zoladex plus 5 g/day T gel
10828362|NCT00114114|EG004|Reported Event|Group 5: 10* g/Day|Zoladex plus 10 g/day T gel; *Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial
10828363|NCT00114114|EG005|Reported Event|Group 6: PBO/PBO|Placebo Zoladex plus Placebo T gel
10828364|NCT00114127|BG000|Baseline|Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
10828365|NCT00114127|BG001|Baseline|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
10828366|NCT00114127|BG002|Baseline|Total|Total of all reporting groups
10828367|NCT00114127|FG000|Participant Flow|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
10828368|NCT00114127|FG001|Participant Flow|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
10828369|NCT00114127|OG000|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
10828370|NCT00114127|OG001|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
10828371|NCT00114127|EG000|Reported Event|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
10828372|NCT00114127|EG001|Reported Event|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
10828373|NCT00114166|BG000|Baseline|Regimen I (Topotecan 1.25 mg/m2)|Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
10828374|NCT00114166|BG001|Baseline|Regimen II (Topotecan 4.0 mg/m2)|Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
10828375|NCT00114166|BG002|Baseline|Total|Total of all reporting groups
10828376|NCT00114166|FG000|Participant Flow|Regimen I (Topotecan 1.25 mg/m2)|Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
10828377|NCT00114166|FG001|Participant Flow|Regimen II (Topotecan 4.0 mg/m2 )|Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
10828378|NCT00114166|OG000|Outcome|Regimen I (Topotecan 1.25 mg/m2)|Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
10828379|NCT00114166|OG001|Outcome|Regimen II (Topotecan 4.0 mg/m2)|Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
10828380|NCT00114166|OG000|Outcome|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
10828381|NCT00114166|OG001|Outcome|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
11328253|NCT03425396|BG003|Baseline|Omadacycline 450/450 Once Every 12 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
10828382|NCT00114166|EG000|Reported Event|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
10828383|NCT00114166|EG001|Reported Event|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
10828384|NCT00114218|BG000|Baseline|Treatment (Gemcitabine Hydrochloride, Docetaxel)|"Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Gemcitabine Hydrochloride: Given IV~Docetaxel: Given IV"
10828385|NCT00114218|FG000|Participant Flow|Treatment (Gemcitabine Hydrochloride, Docetaxel)|"Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Gemcitabine Hydrochloride: Given IV~Docetaxel: Given IV"
10828386|NCT00114218|OG000|Outcome|Treatment (Gemcitabine Hydrochloride, Docetaxel)|"Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Gemcitabine Hydrochloride: Given IV~Docetaxel: Given IV"
10828387|NCT00114218|EG000|Reported Event|Treatment (Gemcitabine Hydrochloride, Docetaxel)|"Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Gemcitabine Hydrochloride: Given IV~Docetaxel: Given IV"
10828388|NCT00114231|BG000|Baseline|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3-4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1-14 and 22-35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828389|NCT00114231|BG001|Baseline|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828390|NCT00114231|BG002|Baseline|Total|Total of all reporting groups
10828391|NCT00114231|FG000|Participant Flow|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3-4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1-14 and 22-35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828392|NCT00114231|FG001|Participant Flow|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828393|NCT00114231|OG000|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
10828394|NCT00114231|EG000|Reported Event|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3-4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1-14 and 22-35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828395|NCT00114231|EG001|Reported Event|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4-8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
10828396|NCT00114244|BG000|Baseline|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
10828397|NCT00114244|BG001|Baseline|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
10828398|NCT00114244|BG002|Baseline|Total|Total of all reporting groups
10828399|NCT00114244|FG000|Participant Flow|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
10828400|NCT00114244|FG001|Participant Flow|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
10828401|NCT00114244|OG000|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
10828402|NCT00114244|OG001|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
10828403|NCT00114244|EG000|Reported Event|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
10828404|NCT00114244|EG001|Reported Event|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
10828405|NCT00114504|BG000|Baseline|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
10828406|NCT00114504|BG001|Baseline|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
10828407|NCT00114504|BG002|Baseline|Total|Total of all reporting groups
10828408|NCT00114504|FG000|Participant Flow|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
10828409|NCT00114504|FG001|Participant Flow|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
10828410|NCT00114504|OG000|Outcome|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
10828411|NCT00114504|OG001|Outcome|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
10828412|NCT00114504|OG000|Outcome|Simvastatin Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
10828413|NCT00114504|OG001|Outcome|Simvastatin Group at 3 Month|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
10828414|NCT00114504|OG002|Outcome|Control Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
10828415|NCT00114504|OG003|Outcome|Control Group at 3 Months|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
10828416|NCT00114504|EG000|Reported Event|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
10828417|NCT00114504|EG001|Reported Event|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
10828418|NCT00114517|BG000|Baseline|Early Postmenopause 17B-estradiol|
10828419|NCT00114517|BG001|Baseline|Early Postmenopause Placebo|
10828420|NCT00114517|BG002|Baseline|Late Postmenopause 17B-estradiol|
10828421|NCT00114517|BG003|Baseline|Late Postmenopause Placebo|
10828422|NCT00114517|BG004|Baseline|Total|Total of all reporting groups
10828423|NCT00114517|FG000|Participant Flow|Early Postmenopause 17B-estradiol|Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily
10828424|NCT00114517|FG001|Participant Flow|Early Postmenopause Placebo|Early postmenopause <6 years-since-menopause
10828425|NCT00114517|FG002|Participant Flow|Late Postmenopause 17B-estradiol|Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily
10828426|NCT00114517|FG003|Participant Flow|Late Postmenopause Placebo|Late postmenopause >10 years-since-menopause
10828427|NCT00114517|OG000|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
10828428|NCT00114517|OG001|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
10828429|NCT00114517|EG000|Reported Event|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
10828430|NCT00114517|EG001|Reported Event|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
10828431|NCT00114530|BG000|Baseline|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
10828432|NCT00114530|BG001|Baseline|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
10828433|NCT00114530|BG002|Baseline|Total|Total of all reporting groups
10828434|NCT00114530|FG000|Participant Flow|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
10828435|NCT00114530|FG001|Participant Flow|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
10828436|NCT00114530|OG000|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
10828437|NCT00114530|OG001|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
10828438|NCT00114530|OG000|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
10828439|NCT00114530|OG001|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
10828440|NCT00114530|OG002|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
10828441|NCT00114530|OG003|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
10828442|NCT00114530|EG000|Reported Event|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
10828443|NCT00114530|EG001|Reported Event|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
10828444|NCT00114634|BG000|Baseline|Egg Yolk or no Egg Yolk|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
10843027|NCT00251589|EG003|Reported Event|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
10828445|NCT00114634|FG000|Participant Flow|Egg Yolk or no Egg Yolk|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
10828446|NCT00114634|OG000|Outcome|Crossover Study|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
10828447|NCT00114634|OG000|Outcome|Placebo|egg substitute
10828448|NCT00114634|OG001|Outcome|Cholesterol|pasteurized egg yolk
10828449|NCT00114634|EG000|Reported Event|Group 1|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
10828450|NCT00114738|BG000|Baseline|All Participants|"All Participants who received at least one dose of Bortezomib alone followed by EPOCH-R+B chemotherapy.~Bortezomib (B): Bortezomib is given alone for one cycle.~Combo chemo etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-Rituxan (R) + Bortezomib (B)~Rituximab (R): Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.~EPOCH: EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.~Bortezomib (B): Bortezomib is given alone for one cycle. Bortezomib or observation: At the beginning of Part C, patients are randomized to receive bortezomib maintenance or be observed w/o bortezomib."
10828451|NCT00114738|FG000|Participant Flow|Bortezomib Then Bortezomib + DA-EPOCH-R Induction|Bortezomib is given alone for one cycle, then combo chemo etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-Rituxan (R) + Bortezomib (B) is given every 3 weeks for 6 cycles.
10828452|NCT00114738|FG001|Participant Flow|Bortezomib Maintenance|Bortezomib alone is given in 3 week cycles. 3-week cycles continue up to 18 months or until the disease comes back or worsens.
10828453|NCT00114738|FG002|Participant Flow|Observation|Participants are observed without treatment.
10828454|NCT00114738|OG000|Outcome|Bortezomib Maintenance|"Bortezomib maintenance~Bortezomib: Bortezomib is given with EPOCH and rituximab every 3 weeks for 6 cycles."
10828455|NCT00114738|OG001|Outcome|Observation|Observation without bortezomib
10828456|NCT00114738|OG002|Outcome|Not Randomized|"Twenty-three patients were not randomized. Sixteen due to neuropathy and seven due to other reasons."
10828457|NCT00114738|OG000|Outcome|EPOCH-R+Bortezomib|"Combo chemo etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-Rituxan (R) + Bortezomib (B)~Rituximab (R): Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.~EPOCH: EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.~Bortezomib (B): Bortezomib is given alone for one cycle."
10828458|NCT00114738|EG000|Reported Event|EPOCH-R+Bortezomib|"Combo chemo etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-Rituxan (R) + Bortezomib (B)~Rituximab (R): Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.~EPOCH: EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.~Bortezomib (B): Bortezomib is given alone for one cycle."
10828459|NCT00114777|BG000|Baseline|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
10828460|NCT00114777|BG001|Baseline|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
10828461|NCT00114777|BG002|Baseline|Cyclosporin A (CsA)|Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
10828462|NCT00114777|BG003|Baseline|Total|Total of all reporting groups
10828463|NCT00114777|FG000|Participant Flow|Belatacept More Intensive (MI) Regimen|Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
10828464|NCT00114777|FG001|Participant Flow|Belatacept Less Intensive (LI) Regimen|Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
10828465|NCT00114777|FG002|Participant Flow|Cyclosporin A (CsA)|Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
10828466|NCT00114777|OG000|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
10828467|NCT00114777|OG001|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
10828468|NCT00114777|OG002|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
10828469|NCT00114777|OG001|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84months.
10828470|NCT00114777|EG000|Reported Event|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
10828471|NCT00114777|EG001|Reported Event|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
10828472|NCT00114777|EG002|Reported Event|Cyclosporin (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
10828473|NCT00114959|BG000|Baseline|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
10828474|NCT00114959|FG000|Participant Flow|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
10828475|NCT00114959|OG000|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
10828476|NCT00114959|EG000|Reported Event|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
10828477|NCT00114972|BG000|Baseline|CABG|Coronary Artery By-pass Graft (CABG)
10828478|NCT00114972|BG001|Baseline|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
10828479|NCT00114972|BG002|Baseline|Total|Total of all reporting groups
10828480|NCT00114972|FG000|Participant Flow|CABG|Coronary Artery By-pass Graft (CABG)
10828481|NCT00114972|FG001|Participant Flow|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
10828482|NCT00114972|OG000|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
10828483|NCT00114972|OG001|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
10828484|NCT00114972|EG000|Reported Event|CABG|Coronary Artery By-pass Graft (CABG)
10828485|NCT00114972|EG001|Reported Event|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
10828486|NCT00115037|BG000|Baseline|Phase1: Liberal|Definition B of heavy drinker: 5+ days of binge drinking
10828487|NCT00115037|BG001|Baseline|Phase1: Stringent|Definition A of heavy drinker: 2+ days of binge drinking
10828488|NCT00115037|BG002|Baseline|Total|Total of all reporting groups
10828489|NCT00115037|FG000|Participant Flow|Phase1: Liberal|"Relapse/non-responder defined as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828490|NCT00115037|FG001|Participant Flow|Phase1: Stringent|"Relapse/non-responder defined as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828491|NCT00115037|FG002|Participant Flow|Phase2: Responder - Naltx (Usual Care)|Phase 2: Naltrexone and TAU for phase 1 responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
10828492|NCT00115037|FG003|Participant Flow|Phase2: Responder - Naltx+Phone (TDM)|Phase 2: Naltrexone and telephone counseling for responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Telephone Counseling: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
10828493|NCT00115037|FG004|Participant Flow|Phase2: Non-responder - Naltx, MM and CBI|"Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks."
10828494|NCT00115037|FG005|Participant Flow|Phase2: Non-responder - Placebo, MM and CBI|"Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR) placebo: placebo comparer for 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks."
10828495|NCT00115037|OG000|Outcome|Phase 1 Liberal Response|"From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828496|NCT00115037|OG001|Outcome|Phase 1 Stringent Response|"From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828497|NCT00115037|OG000|Outcome|Phase 2 Naltrexone for Responders|"Phase 2: Naltrexone and TAU for phase 1 responders.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828498|NCT00115037|OG001|Outcome|Phase 2 Nalt and Tele for Responders|"Phase 2: Naltrexone and telephone counseling for responders.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.~Telephone Counseling: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM."
10828499|NCT00115037|OG002|Outcome|Phase 2 Nalt, MM and CBI for NR|"Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.~Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks."
10828500|NCT00115037|OG003|Outcome|Phase 2 Placebo, MM and CBI for NR|"Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR)~placebo: placebo comparer for 16 weeks in phase 2.~Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks."
10828501|NCT00115037|EG000|Reported Event|Phase1: Liberal|"Relapse/non-responder defined as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828502|NCT00115037|EG001|Reported Event|Phase1: Stringent|"Relapse/non-responder defined as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2."
10828503|NCT00115037|EG002|Reported Event|Phase2: Responder - Naltx (Usual Care)|Phase 2: Naltrexone and TAU for phase 1 responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
10828504|NCT00115037|EG003|Reported Event|Phase2: Responder - Naltx+Phone (TDM)|Phase 2: Naltrexone and telephone counseling for responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Telephone Counseling: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
10828505|NCT00115037|EG004|Reported Event|Phase2: Non-responder - Naltx, MM and CBI|"Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).~Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks."
10828506|NCT00115037|EG005|Reported Event|Phase2: Non-responder - Placebo, MM and CBI|"Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR) placebo: placebo comparer for 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.~Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 wee"
10828507|NCT00115063|BG000|Baseline|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
10828508|NCT00115063|BG001|Baseline|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
10828509|NCT00115063|BG002|Baseline|Total|Total of all reporting groups
10828510|NCT00115063|FG000|Participant Flow|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
10828511|NCT00115063|FG001|Participant Flow|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
10828512|NCT00115063|OG000|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
10828513|NCT00115063|OG001|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
10828514|NCT00115063|EG000|Reported Event|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
10828515|NCT00115063|EG001|Reported Event|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
10828516|NCT00115076|BG000|Baseline|Psoriasis|"moderate to severe plaque psoriasis~Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection"
10828517|NCT00115076|FG000|Participant Flow|Psoriasis|"moderate to severe plaque psoriasis~Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection"
10828518|NCT00115076|OG000|Outcome|Psoriasis|"moderate to severe plaque psoriasis~Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection"
10828519|NCT00115076|EG000|Reported Event|Psoriasis|"moderate to severe plaque psoriasis~Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection"
10828520|NCT00115297|BG000|Baseline|Montelukast|"5-mg montelukast tablets or 4 mg granules~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules."
10828521|NCT00115297|BG001|Baseline|Placebo|"Placebo (placebo tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules."
10828522|NCT00115297|BG002|Baseline|Total|Total of all reporting groups
10828523|NCT00115297|FG000|Participant Flow|Monteluksat|"5-mg montelukast tablets or 4 mg granules)~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules."
10828524|NCT00115297|FG001|Participant Flow|Placebo|"Placebo (montelukast tablet or montelukast granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
10828525|NCT00115297|OG000|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
10828526|NCT00115297|OG001|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
10828527|NCT00115297|OG001|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
10828528|NCT00115297|OG000|Outcome|Montelukast|"5-mg montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
10828529|NCT00115297|OG001|Outcome|Placebo|"Placebo (tablets or granules)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
10828530|NCT00115297|EG000|Reported Event|Montelukast|"Montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
10828531|NCT00115297|EG001|Reported Event|Placebo|"Placebo (tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
10828532|NCT00115336|BG000|Baseline|IV Ketorolac / Oral Placebo|Intravenous ketorolac and oral placebo
10828533|NCT00115336|BG001|Baseline|IV Placebo / Oral Ibuprofen|Intravenous placebo abd oral ibuprofen
10828534|NCT00115336|BG002|Baseline|Total|Total of all reporting groups
10828535|NCT00115336|FG000|Participant Flow|IV Ketorolac / Oral Placebo|Intravenous ketorolac and oral placebo
10828536|NCT00115336|FG001|Participant Flow|IV Placebo / Oral Ibuprofen|Intravenous placebo and oral ibuprofen
10828537|NCT00115336|OG000|Outcome|IV Ketorolac / Oral Placebo|Intravenous ketorolac and oral placebo
10828538|NCT00115336|OG001|Outcome|IV Placebo / Oral Ibuprofen|Intravenous placebo and oral ibuprofen
10828539|NCT00115336|OG000|Outcome|Intravenous Ketorolac and Oral Placebo|"Intravenous ketorolac and oral placebo~Intravenous Ketorolac: Intravenous ketorolac"
10828540|NCT00115336|OG001|Outcome|Intravenous Placebo and Oral Ibuprofen|"Intravenous placebo and oral ibuprofen~Ibuprofen: Ibuprofen, taken orally"
10828541|NCT00115336|EG000|Reported Event|IV Ketorolac / Oral Placebo|Intravenous ketorolac and oral placebo
10828542|NCT00115336|EG001|Reported Event|IV Placebo / Oral Ibuprofen|Intravenous placebo and oral ibuprofen
10828543|NCT00115349|BG000|Baseline|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
10828544|NCT00115349|BG001|Baseline|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
10828545|NCT00115349|BG002|Baseline|Total|Total of all reporting groups
10828546|NCT00115349|FG000|Participant Flow|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
10828547|NCT00115349|FG001|Participant Flow|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
10828548|NCT00115349|OG000|Outcome|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
10828549|NCT00115349|OG001|Outcome|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
10828550|NCT00115349|EG000|Reported Event|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
10828551|NCT00115349|EG001|Reported Event|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
10828552|NCT00115739|BG000|Baseline|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
10828553|NCT00115739|FG000|Participant Flow|Imatinib (Gleevec) Tablets|4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
10828554|NCT00115739|OG000|Outcome|Imatinib (Gleevec) Tablets|Subjects were administered oral Gleevec tablets, then tumor response was assessed
10828555|NCT00115739|OG000|Outcome|Imatinib (Gleevec) Tablets|
10828556|NCT00115739|OG000|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
10828557|NCT00115739|EG000|Reported Event|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
10828558|NCT00115765|BG000|Baseline|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
10828559|NCT00115765|BG001|Baseline|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828560|NCT00115765|BG002|Baseline|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
10828561|NCT00115765|BG003|Baseline|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828562|NCT00115765|BG004|Baseline|Total|Total of all reporting groups
10828563|NCT00115765|FG000|Participant Flow|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
10828564|NCT00115765|FG001|Participant Flow|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828565|NCT00115765|FG002|Participant Flow|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
10828566|NCT00115765|FG003|Participant Flow|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828567|NCT00115765|OG000|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828568|NCT00115765|OG001|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
10828569|NCT00115765|OG000|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
10828570|NCT00115765|OG001|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
10828571|NCT00115765|EG000|Reported Event|Panit. Plus Bevacizumab With Chemotherapy|
10828572|NCT00115765|EG001|Reported Event|Bevacizumab With Chemotherapy|
10828573|NCT00115778|BG000|Baseline|All Participants|Study participants consented to receive three doses of IVIG (or 0.1% albumin solution (placebo)) given four weeks apart followed by a twelve-week washout and then three doses of placebo (or IVIG).
10828574|NCT00115778|FG000|Participant Flow|Group 1: Placebo Then IVIG|"Study participants consented to receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of IVIG over 12 weeks (period 2).~Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)~Analysis: modified intention-to-treat"
10828575|NCT00115778|FG001|Participant Flow|Group: 2 IVIG Then Placebo|"Study participants consented to receive three doses of IVIG given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of placebo over 12 weeks (period 2).~Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)~Analysis: modified intention-to-treat"
10828576|NCT00115778|OG000|Outcome|Participants Receiving IVIG During Period 1 or Period 2|Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
10828577|NCT00115778|OG001|Outcome|Participants Receiving Placebo During Period 1 or Period 2|Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
10828578|NCT00115778|EG000|Reported Event|Participants Receiving IVIG During Period 1 or Period 2|Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
10828579|NCT00115778|EG001|Reported Event|Participants Receiving Placebo During Period 1 or Period 2|Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
10828580|NCT00115804|BG000|Baseline|Fluoxetine|All eligible patients were given fluoxetine
10828581|NCT00115804|FG000|Participant Flow|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
10828582|NCT00115804|OG000|Outcome|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
10828583|NCT00115804|OG000|Outcome|Fluoxetine|"All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.~Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks~Fluoxetine: Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily."
10828584|NCT00115804|OG000|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
10828585|NCT00115804|EG000|Reported Event|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
10828586|NCT00115869|BG000|Baseline|No-intervention Control|No-intervention control group
10828587|NCT00115869|BG001|Baseline|Social Influences School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
10828588|NCT00115869|BG002|Baseline|Total|Total of all reporting groups
10828589|NCT00115869|FG000|Participant Flow|No-intervention Control|No-intervention control group
10828590|NCT00115869|FG001|Participant Flow|Grade 3-12 School-based Intervention|Grade 3-12 school-influences school-based smoking prevention intervention
10828591|NCT00115869|OG000|Outcome|No-intervention Control|No-intervention control condition
10828592|NCT00115869|OG001|Outcome|Social Influences School-based Smoking Prevention Curriculum|School-based social-influences smoking prevention curriculum condition
10828593|NCT00115869|OG000|Outcome|No-intervention Control|No-intervention control group
10828594|NCT00115869|OG001|Outcome|School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
10828595|NCT00115869|EG000|Reported Event|No-intervention Control Group|no-intervention control
10828596|NCT00115869|EG001|Reported Event|School-based Smoking Prevention Curriculum Group|school-based smoking prevention curriculum
10828597|NCT00115934|BG000|Baseline|MBTS|Blalock-Taussig pulmonary artery shunt
10828598|NCT00115934|BG001|Baseline|RVPAS|Right ventricular to pulmonary artery shunt
10828599|NCT00115934|BG002|Baseline|Total|Total of all reporting groups
10828600|NCT00115934|FG000|Participant Flow|MBTS|Blalock-Taussig pulmonary artery shunt
10828601|NCT00115934|FG001|Participant Flow|RVPAS|Right ventricular to pulmonary artery shunt
10828602|NCT00115934|OG000|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
10828603|NCT00115934|OG001|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
10828604|NCT00115934|EG000|Reported Event|MBTS|Blalock-Taussig pulmonary artery shunt
10828605|NCT00115934|EG001|Reported Event|RVPAS|Right ventricular to pulmonary artery shunt
10828606|NCT00116168|BG000|Baseline|MEDI-528 0.3 mg|
10828607|NCT00116168|BG001|Baseline|MEDI-528 1 mg|
10828608|NCT00116168|BG002|Baseline|MEDI-528 3 mg|
10828609|NCT00116168|BG003|Baseline|MEDI-528 9 mg|
10828610|NCT00116168|BG004|Baseline|Total|Total of all reporting groups
10828611|NCT00116168|FG000|Participant Flow|MEDI-528 0.3 mg|
10828612|NCT00116168|FG001|Participant Flow|MEDI-528 1 mg|
10828613|NCT00116168|FG002|Participant Flow|MEDI-528 3 mg|
10828614|NCT00116168|FG003|Participant Flow|MEDI-528 9 mg|
10828615|NCT00116168|OG000|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
10828616|NCT00116168|OG001|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
10828617|NCT00116168|OG002|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
10828618|NCT00116168|OG003|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
10828619|NCT00116168|EG000|Reported Event|MEDI-528 0.3 mg|
10828620|NCT00116168|EG001|Reported Event|MEDI-528 1 mg|
10828621|NCT00116168|EG002|Reported Event|MEDI-528 3 mg|
10828622|NCT00116168|EG003|Reported Event|MEDI-528 9 mg|
10828623|NCT00116207|BG000|Baseline|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828624|NCT00116207|BG001|Baseline|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828625|NCT00116207|BG002|Baseline|Total|Total of all reporting groups
10828626|NCT00116207|FG000|Participant Flow|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828627|NCT00116207|FG001|Participant Flow|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828628|NCT00116207|OG000|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828629|NCT00116207|OG001|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828630|NCT00116207|EG000|Reported Event|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828631|NCT00116207|EG001|Reported Event|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
10828632|NCT00116272|BG000|Baseline|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
10828633|NCT00116272|BG001|Baseline|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
10828634|NCT00116272|BG002|Baseline|Total|Total of all reporting groups
10828635|NCT00116272|FG000|Participant Flow|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
10828636|NCT00116272|FG001|Participant Flow|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
10828637|NCT00116272|OG000|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
10828638|NCT00116272|OG001|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
10828639|NCT00116272|EG000|Reported Event|Mothers Diseased Control|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
10828640|NCT00116272|EG001|Reported Event|Mothers Etanercept Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
10828641|NCT00116272|EG002|Reported Event|Infants Diseased Control|Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
10828642|NCT00116272|EG003|Reported Event|Infants Etanercept Exposed|Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
10828643|NCT00116337|BG000|Baseline|Clinical Trial - Spinal Cord Stimulation Cough System|"Design: Clinical trial.~Participants: Subjects with cervical spinal cord injury and weak cough.~Interventions: A fully implantable electrical stimulation system was surgically placed in each subject."
10828644|NCT00116337|FG000|Participant Flow|Clinical Trial - Spinal Cord Stimulation to Restore Cough|Design: Clinical trial. Participants: Subjects with cervical spinal cord injury and weak cough. Interventions: A fully implantable electrical stimulation system was surgically placed in each subject.
10828645|NCT00116337|OG000|Outcome|Pre-Implant - Spontaneous Effort|Airway pressure generation during spontaneous efforts.
10828646|NCT00116337|OG001|Outcome|Post-Implantation - Spinal Cord Stimulation (SCS)|Changes in airway pressure generation during SCS at the 1-year follow-up.
10828647|NCT00116337|OG000|Outcome|Pre-Implant - Spontaneous Effort|Peak expiratory airflow (L/s) during spontaneous efforts.
10828648|NCT00116337|OG001|Outcome|Post-Implantation - Spinal Cord Stimulation (SCS)|Changes in peak airflow during SCS at the 1-year follow-up.
10828649|NCT00116337|OG000|Outcome|Respiratory Tract Infections - Pre-Implant|The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked over the 2-year period prior to implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
10828650|NCT00116337|OG001|Outcome|Respiratory Tract Infections - Post-Implant|After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.
10828651|NCT00116337|OG000|Outcome|Pre-Implant|The degree of caregiver support was determined by the number of times it was necessary for a caregiver to provide the subject with an assistive means of secretion clearance, such as suctioning, manually assisted cough, or insufflation-exsufflation device use. This was determined prospectively over the 2-week period prior to implantation of the cough system
10828652|NCT00116337|OG001|Outcome|Post-Implantation - Spinal Cord Stimulation (SCS)|The degree of caregiver support was determined by the number of times it was necessary for a caregiver to provide the subject with an assistive means of secretion clearance, such as suctioning, manually assisted cough, or insufflation-exsufflation device use. This was re-evaluated over a 2-week period after implantation of the cough system at the 1-year time points.
10828653|NCT00116337|EG000|Reported Event|Post-Implantation - Spinal Cord Stimulation (SCS)|Hemodynamic effects: Increases in blood pressure in association with the initial application of SCS.
10828654|NCT00116428|BG000|Baseline|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10828655|NCT00116428|BG001|Baseline|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
10828656|NCT00116428|BG002|Baseline|Total|Total of all reporting groups
10828657|NCT00116428|FG000|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10828658|NCT00116428|FG001|Participant Flow|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
10828659|NCT00116428|OG000|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10828660|NCT00116428|OG001|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
10828661|NCT00116428|OG001|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
10828662|NCT00116428|OG002|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
10828663|NCT00116428|OG001|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
10828664|NCT00116428|EG000|Reported Event|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
10828665|NCT00116428|EG001|Reported Event|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
10828666|NCT00116558|BG000|Baseline|Standard of Care NIPPV and Nutritional Monitoring|Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.
10828667|NCT00116558|BG001|Baseline|Standard of Care NIPPV|Participants with 50-74% predicted forced vital capacity (FVC).
10828668|NCT00116558|BG002|Baseline|Early NIPPV Intervention|Participants with >80% predicted forced vital capacity (FVC).
10828669|NCT00116558|BG003|Baseline|Total|Total of all reporting groups
10828670|NCT00116558|FG000|Participant Flow|Standard of Care NIPPV and Nutritional Monitoring|Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.
10828671|NCT00116558|FG001|Participant Flow|Standard of Care NIPPV|Participants with 50-74% predicted forced vital capacity (FVC).
10828672|NCT00116558|FG002|Participant Flow|Early NIPPV|Participants with >80% predicted forced vital capacity (FVC).
10828673|NCT00116558|OG000|Outcome|Standard of Care NIPPV and Nutritional Monitoring|Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.
10828674|NCT00116558|OG001|Outcome|Standard of Care NIPPV|Participants with 50-74% predicted forced vital capacity (FVC).
10828675|NCT00116558|OG002|Outcome|Early NIPPV Intervention|Participants with >80% predicted forced vital capacity (FVC).
10828676|NCT00116558|OG002|Outcome|Early NIPPV|Participants with >80% predicted forced vital capacity (FVC).
10828677|NCT00116558|EG000|Reported Event|Combined Arms|Sincere efforts were made to locate per arm data, but these data are no longer available. All adverse events are reported as one arm/group.
10828678|NCT00116584|BG000|Baseline|Heliox|heliox-driven nebulizations for children with moderate to severe bronchiolitis
10828679|NCT00116584|BG001|Baseline|Oxygen|Oxygen nebulizations for children with moderate to severe bronchiolitis
10828680|NCT00116584|BG002|Baseline|Total|Total of all reporting groups
10828681|NCT00116584|FG000|Participant Flow|Heliox|Patients were randomized to the helium-oxygen received nebulized racemic epinephrine via a face mask.
10828682|NCT00116584|FG001|Participant Flow|Oxygen|Patients were randomized to 100% oxygen group and received nebulized racemic epinephrine via a face mask.
10828683|NCT00116584|OG000|Outcome|Heliox|heliox-driven nebulizations for children with moderate to severe bronchiolitis
10828684|NCT00116584|OG001|Outcome|Oxygen|Oxygen nebulizations for children with moderate to severe bronchiolitis
10828685|NCT00116584|EG000|Reported Event|Heliox|heliox-driven nebulizations for children with moderate to severe bronchiolitis
10828686|NCT00116584|EG001|Reported Event|Oxygen|Oxygen nebulizations for children with moderate to severe bronchiolitis
10828687|NCT00116649|BG000|Baseline|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
10828688|NCT00116649|FG000|Participant Flow|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
10828689|NCT00116649|OG000|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
10828690|NCT00116649|EG000|Reported Event|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
10828691|NCT00116688|BG000|Baseline|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
10828692|NCT00116688|BG001|Baseline|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
10828693|NCT00116688|BG002|Baseline|Total|Total of all reporting groups
10828694|NCT00116688|FG000|Participant Flow|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
10828695|NCT00116688|FG001|Participant Flow|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
10828696|NCT00116688|OG000|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
10828697|NCT00116688|OG001|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
10828698|NCT00116688|EG000|Reported Event|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
10828699|NCT00116688|EG001|Reported Event|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
10828700|NCT00116753|BG000|Baseline|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
10828701|NCT00116753|BG001|Baseline|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
10828702|NCT00116753|BG002|Baseline|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
10828703|NCT00116753|BG003|Baseline|Total|Total of all reporting groups
10828704|NCT00116753|FG000|Participant Flow|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
10828705|NCT00116753|FG001|Participant Flow|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
10828706|NCT00116753|FG002|Participant Flow|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
10828707|NCT00116753|OG000|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
10828708|NCT00116753|OG001|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
10828709|NCT00116753|OG002|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
10828710|NCT00116753|EG000|Reported Event|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
10828711|NCT00116753|EG001|Reported Event|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
10828712|NCT00116753|EG002|Reported Event|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
10828713|NCT00116779|BG000|Baseline|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
10828714|NCT00116779|BG001|Baseline|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
10828715|NCT00116779|BG002|Baseline|Total|Total of all reporting groups
10828716|NCT00116779|FG000|Participant Flow|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
10828717|NCT00116779|FG001|Participant Flow|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
10828718|NCT00116779|OG000|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
10828719|NCT00116779|OG001|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
10828720|NCT00116779|EG000|Reported Event|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
10828721|NCT00116779|EG001|Reported Event|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
10828722|NCT00116805|BG000|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828723|NCT00116805|BG001|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828724|NCT00116805|BG002|Baseline|Total|Total of all reporting groups
10828725|NCT00116805|FG000|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period.
10828726|NCT00116805|FG001|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828727|NCT00116805|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828728|NCT00116805|OG001|Outcome|ADV 10 mg|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828729|NCT00116805|OG001|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828730|NCT00116805|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828731|NCT00116805|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period..
10828732|NCT00116805|OG001|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828733|NCT00116805|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
10828734|NCT00116805|OG001|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
10828735|NCT00116805|OG002|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
10828736|NCT00116805|OG003|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
10828737|NCT00116805|EG000|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
10828738|NCT00116805|EG001|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
10828739|NCT00116805|EG002|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 480), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg + ADV placebo or ADV 10 mg + TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
10828740|NCT00116831|BG000|Baseline|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
10828741|NCT00116831|BG001|Baseline|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
10828742|NCT00116831|BG002|Baseline|Total|Total of all reporting groups
10828743|NCT00116831|FG000|Participant Flow|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
10828744|NCT00116831|FG001|Participant Flow|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
10828745|NCT00116831|OG000|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
10828746|NCT00116831|OG001|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
10828747|NCT00116831|EG000|Reported Event|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
10828748|NCT00116831|EG001|Reported Event|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
10828749|NCT00116844|BG000|Baseline|Sequence 1: VALTREX 1 g Once Daily, Placebo|Participants randomized to this sequence received VALTREX 1 g once daily for 60 days, to be taken as two 500 mg caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
10828750|NCT00116844|BG001|Baseline|Sequence 2: Placebo, VALTREX 1 g Once Daily|Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
10828751|NCT00116844|BG002|Baseline|Total|Total of all reporting groups
10828752|NCT00116844|FG000|Participant Flow|Sequence 1: VALTREX 1 g Once Daily, Placebo|Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
10828753|NCT00116844|FG001|Participant Flow|Sequence 2: Placebo, VALTREX 1 g Once Daily|Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
10828754|NCT00116844|OG000|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
10828755|NCT00116844|OG001|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
10828756|NCT00116844|EG000|Reported Event|Valtrex 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
10828757|NCT00116844|EG001|Reported Event|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
10828758|NCT00116857|BG000|Baseline|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
10828759|NCT00116857|BG001|Baseline|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
10828760|NCT00116857|BG002|Baseline|Total|Total of all reporting groups
10828761|NCT00116857|FG000|Participant Flow|Sertraline Plus Omega-3 Supplement|Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
10828762|NCT00116857|FG001|Participant Flow|Sertraline/Corn Oil|Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
10828763|NCT00116857|OG000|Outcome|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
10828764|NCT00116857|OG001|Outcome|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
10828765|NCT00116857|EG000|Reported Event|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
10828766|NCT00116857|EG001|Reported Event|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
10828767|NCT00117143|BG000|Baseline|Romiplostim 30 µg|Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828768|NCT00117143|BG001|Baseline|Romiplostim 100 µg|Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828769|NCT00117143|BG002|Baseline|Romiplostim 300 µg|Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828770|NCT00117143|BG003|Baseline|Romiplostim 500 µg|Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828771|NCT00117143|BG004|Baseline|Total|Total of all reporting groups
10828772|NCT00117143|FG000|Participant Flow|Romiplostim 30 µg|Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828773|NCT00117143|FG001|Participant Flow|Romiplostim 100 µg|Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828774|NCT00117143|FG002|Participant Flow|Romiplostim 300 µg|Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828775|NCT00117143|FG003|Participant Flow|Romiplostim 500 µg|Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828776|NCT00117143|OG000|Outcome|Romiplostim 30 µg|Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828777|NCT00117143|OG001|Outcome|Romiplostim 100 µg|Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828778|NCT00117143|OG002|Outcome|Romiplostim 300 µg|Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828779|NCT00117143|OG003|Outcome|Romiplostim 500 µg|Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828780|NCT00117143|EG000|Reported Event|Romiplostim 30 µg|Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828781|NCT00117143|EG001|Reported Event|Romiplostim 100 µg|Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828782|NCT00117143|EG002|Reported Event|Romiplostim 300 µg|Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828783|NCT00117143|EG003|Reported Event|Romiplostim 500 µg|Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
10828784|NCT00117156|BG000|Baseline|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
10828785|NCT00117156|FG000|Participant Flow|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
10828786|NCT00117156|OG000|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
10828787|NCT00117156|EG000|Reported Event|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
10828788|NCT00117286|BG000|Baseline|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828789|NCT00117286|BG001|Baseline|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828790|NCT00117286|BG002|Baseline|Total|Total of all reporting groups
10828791|NCT00117286|FG000|Participant Flow|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828792|NCT00117286|FG001|Participant Flow|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828793|NCT00117286|OG000|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828794|NCT00117286|OG001|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828795|NCT00117286|EG000|Reported Event|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828796|NCT00117286|EG001|Reported Event|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10828797|NCT00117312|BG000|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828798|NCT00117312|BG001|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828799|NCT00117312|BG002|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828800|NCT00117312|BG003|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828801|NCT00117312|BG004|Baseline|Total|Total of all reporting groups
10828802|NCT00117312|FG000|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828803|NCT00117312|FG001|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828804|NCT00117312|FG002|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828805|NCT00117312|FG003|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828806|NCT00117312|OG000|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828807|NCT00117312|OG001|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828808|NCT00117312|OG002|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828809|NCT00117312|OG003|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828810|NCT00117312|EG000|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828811|NCT00117312|EG001|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828812|NCT00117312|EG002|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828813|NCT00117312|EG003|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828814|NCT00117325|BG000|Baseline|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828815|NCT00117325|BG001|Baseline|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828816|NCT00117325|BG002|Baseline|Total|Total of all reporting groups
10828817|NCT00117325|FG000|Participant Flow|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828818|NCT00117325|FG001|Participant Flow|Fluticasone Furoate 110 mcg QD|Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828819|NCT00117325|OG000|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828820|NCT00117325|OG001|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828821|NCT00117325|OG001|Outcome|Fluticasone Furoate 110mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828822|NCT00117325|EG000|Reported Event|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828823|NCT00117325|EG001|Reported Event|Fluticasone Furoate 110mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
10828824|NCT00117507|BG000|Baseline|Deferasirox|Participants received deferasirox 20mg/kg/day OD per day for 12 months.
10828825|NCT00117507|FG000|Participant Flow|Deferasirox|Participants received deferasirox 20mg/kg/day OD (Once Daily) per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10828826|NCT00117507|OG000|Outcome|Deferasirox|Participants received deferasirox 20mg/kg/day OD per day for 12 months.
10828827|NCT00117507|OG000|Outcome|Deferasirox|Participants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10828828|NCT00117507|EG000|Reported Event|Deferasirox|Participants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
10828829|NCT00117559|BG000|Baseline|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
10828830|NCT00117559|BG001|Baseline|Treatment as Usual|Control group
10828831|NCT00117559|BG002|Baseline|Total|Total of all reporting groups
10828832|NCT00117559|FG000|Participant Flow|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
10828833|NCT00117559|FG001|Participant Flow|Treatment as Usual|Control group
10828834|NCT00117559|OG000|Outcome|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
10828835|NCT00117559|OG001|Outcome|Treatment as Usual|Control group
10828836|NCT00117559|EG000|Reported Event|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
10828837|NCT00117559|EG001|Reported Event|Treatment as Ususal|Control group
10828838|NCT00117572|BG000|Baseline|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828839|NCT00117572|BG001|Baseline|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828840|NCT00117572|BG002|Baseline|Total|Total of all reporting groups
10828841|NCT00117572|FG000|Participant Flow|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10843028|NCT00251641|BG000|Baseline|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
10843029|NCT00251641|BG001|Baseline|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
10843030|NCT00251641|BG002|Baseline|Total|Total of all reporting groups
10828842|NCT00117572|FG001|Participant Flow|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828843|NCT00117572|OG000|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828844|NCT00117572|OG001|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828845|NCT00117572|EG000|Reported Event|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828846|NCT00117572|EG001|Reported Event|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
10828847|NCT00117585|BG000|Baseline|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
10828848|NCT00117585|FG000|Participant Flow|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
10828849|NCT00117585|OG000|Outcome|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
10828850|NCT00117585|EG000|Reported Event|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
10828851|NCT00117598|BG000|Baseline|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828852|NCT00117598|BG001|Baseline|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828853|NCT00117598|BG002|Baseline|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
10828854|NCT00117598|BG003|Baseline|Total|Total of all reporting groups
11328254|NCT03425396|BG004|Baseline|Nitrofurantoin 100/100 Once Every 12 Hours|Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328255|NCT03425396|BG005|Baseline|Total|Total of all reporting groups
10828855|NCT00117598|FG000|Participant Flow|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828856|NCT00117598|FG001|Participant Flow|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828857|NCT00117598|FG002|Participant Flow|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
10828858|NCT00117598|FG003|Participant Flow|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828859|NCT00117598|FG004|Participant Flow|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828860|NCT00117598|OG000|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828861|NCT00117598|OG001|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828862|NCT00117598|OG002|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
10828863|NCT00117598|EG000|Reported Event|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).
10828864|NCT00117598|EG001|Reported Event|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828865|NCT00117598|EG002|Reported Event|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
10828866|NCT00117598|EG003|Reported Event|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828867|NCT00117598|EG004|Reported Event|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
10828868|NCT00117637|BG000|Baseline|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828869|NCT00117637|BG001|Baseline|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828870|NCT00117637|BG002|Baseline|Total|Total of all reporting groups
10828871|NCT00117637|FG000|Participant Flow|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828872|NCT00117637|FG001|Participant Flow|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828873|NCT00117637|OG000|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828874|NCT00117637|OG001|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828875|NCT00117637|OG000|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828876|NCT00117637|OG001|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828877|NCT00117637|OG000|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828878|NCT00117637|OG001|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828879|NCT00117637|OG000|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828880|NCT00117637|EG000|Reported Event|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828881|NCT00117637|EG001|Reported Event|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828882|NCT00117637|EG002|Reported Event|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
10828883|NCT00117637|EG003|Reported Event|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
10828884|NCT00117676|BG000|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828885|NCT00117676|BG001|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828886|NCT00117676|BG002|Baseline|Total|Total of all reporting groups
10828887|NCT00117676|FG000|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC; as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) to their treatment regimen in the open-label period.
10828888|NCT00117676|FG001|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period.
10828889|NCT00117676|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828890|NCT00117676|OG001|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
10828891|NCT00117676|OG000|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
10828892|NCT00117676|OG001|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
10828893|NCT00117676|OG002|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
10828894|NCT00117676|OG003|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
10828895|NCT00117676|EG000|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
10828896|NCT00117676|EG001|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
10828897|NCT00117676|EG002|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
10828898|NCT00117715|BG000|Baseline|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
10828899|NCT00117715|FG000|Participant Flow|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
10828900|NCT00117715|OG000|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
10828901|NCT00117715|EG000|Reported Event|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
10828902|NCT00117793|BG000|Baseline|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
10828903|NCT00117793|FG000|Participant Flow|Entire Study Population|"This is a randomized cross-over study. Each participant wore both study prostheses: (1) a total surface bearing socket with a vacuum-assisted suspension system (VASS) and (2) a modified patellar tendon bearing socket with a pin lock suspension system (PIN).~Subjects were randomized, provided with one of two study prostheses, and asked to wear it for three weeks. Data was then collected during laboratory visit one, and, following one more week of wearing the first study prosthesis, during laboratory visit two. Participants were then provided with the second study intervention and asked to wear it for three weeks. Data was then collected during laboratory visit three, and, following one more week of wearing the second study intervention, during laboratory visit four.~Data was not collected on the order in which participants received each study intervention"
10828904|NCT00117793|OG000|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
10828905|NCT00117793|OG001|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
10828906|NCT00117793|EG000|Reported Event|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
10828907|NCT00117806|BG000|Baseline|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
10828908|NCT00117806|BG001|Baseline|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
10828909|NCT00117806|BG002|Baseline|Total|Total of all reporting groups
10828910|NCT00117806|FG000|Participant Flow|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
10828911|NCT00117806|FG001|Participant Flow|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
10828912|NCT00117806|OG000|Outcome|Supported Employment|Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
10828913|NCT00117806|OG001|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
10828914|NCT00117806|OG000|Outcome|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
10828915|NCT00117806|OG000|Outcome|Arm 1|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
10828916|NCT00117806|OG001|Outcome|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
10828917|NCT00117806|EG000|Reported Event|Supported Employment|"SCI-VIP: supported employment implemented for veterans with spinal cord injury~Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury."
10828918|NCT00117806|EG001|Reported Event|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
10828919|NCT00117845|BG000|Baseline|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
10828920|NCT00117845|FG000|Participant Flow|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
10828921|NCT00117845|OG000|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
10828922|NCT00117845|EG000|Reported Event|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
10828923|NCT00117949|BG000|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828924|NCT00117949|BG001|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828925|NCT00117949|BG002|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828926|NCT00117949|BG003|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828927|NCT00117949|BG004|Baseline|Total|Total of all reporting groups
10828928|NCT00117949|FG000|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828929|NCT00117949|FG001|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828930|NCT00117949|FG002|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828931|NCT00117949|FG003|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828932|NCT00117949|OG000|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828933|NCT00117949|OG001|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828934|NCT00117949|OG002|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828935|NCT00117949|OG003|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828936|NCT00117949|EG000|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
10828937|NCT00117949|EG001|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
10828938|NCT00117949|EG002|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
10828939|NCT00117949|EG003|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
10828940|NCT00117962|BG000|Baseline|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
10828941|NCT00117962|BG001|Baseline|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
10828942|NCT00117962|BG002|Baseline|Total|Total of all reporting groups
10828943|NCT00117962|FG000|Participant Flow|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
10828944|NCT00117962|FG001|Participant Flow|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
10828945|NCT00117962|OG000|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
10828946|NCT00117962|OG001|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
10828947|NCT00117962|EG000|Reported Event|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
10828948|NCT00117962|EG001|Reported Event|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
10828949|NCT00117988|BG000|Baseline|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
10828950|NCT00117988|FG000|Participant Flow|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
10828951|NCT00117988|OG000|Outcome|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
10828952|NCT00117988|EG000|Reported Event|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
10828953|NCT00118040|BG000|Baseline|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828954|NCT00118040|BG001|Baseline|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828955|NCT00118040|BG002|Baseline|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828956|NCT00118040|BG003|Baseline|Total|Total of all reporting groups
10828957|NCT00118040|FG000|Participant Flow|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828958|NCT00118040|FG001|Participant Flow|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828959|NCT00118040|FG002|Participant Flow|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828960|NCT00118040|OG000|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828961|NCT00118040|OG001|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828962|NCT00118040|OG002|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828963|NCT00118040|OG003|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
10828964|NCT00118040|OG000|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
10828965|NCT00118040|OG001|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828966|NCT00118040|OG002|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828967|NCT00118040|OG003|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
10828968|NCT00118040|EG000|Reported Event|Arm I (Lower Dose Genistein)|"Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
10828969|NCT00118040|EG001|Reported Event|Arm II (Higher Dose Genistein)|"Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
10828970|NCT00118040|EG002|Reported Event|Arm III (Placebo)|"Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~laboratory biomarker analysis: Correlative studies~placebo: Given orally~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
10828971|NCT00118092|BG000|Baseline|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10828972|NCT00118092|FG000|Participant Flow|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10828973|NCT00118092|OG000|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10828974|NCT00118092|OG000|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.~> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
10828975|NCT00118092|EG000|Reported Event|Treatment (Tanespimycin)|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10828976|NCT00118131|BG000|Baseline|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
10828977|NCT00118131|FG000|Participant Flow|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
10828978|NCT00118131|OG000|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
10828979|NCT00118131|EG000|Reported Event|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
10828980|NCT00118144|BG000|Baseline|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
10828981|NCT00118144|FG000|Participant Flow|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
10828982|NCT00118144|OG000|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
10828983|NCT00118144|OG000|Outcome|Arm I|"Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.~bortezomib: Given IV"
10828984|NCT00118144|EG000|Reported Event|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
10828985|NCT00118157|BG000|Baseline|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
10828986|NCT00118157|FG000|Participant Flow|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
10828987|NCT00118157|OG000|Outcome|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
10828988|NCT00118157|OG000|Outcome|Treatment (Lapatinib, Tamoxifen)|"Patients receive lapatinib ditosylate PO daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Tamoxifen Citrate: Given PO"
10828989|NCT00118157|EG000|Reported Event|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
10828990|NCT00118209|BG000|Baseline|Arm A - R-CHOP|"Patients receive the following treatment:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>~Cyclophosphamide 750 mg/m^2 IV on Day 1>~Doxorubicin 50 mg/m^2 IV on Day 1>~Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>~Prednisone 40 mg/m^2/day PO on Days 1-5>~filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6."
10828991|NCT00118209|BG001|Baseline|Arm B - DA-EPOCH-R|"Patients receive the following treatment:> Cycle 1 Doses:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>~Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>~Etoposide 50 mg/m^2/day CIVI on Days 1-4>~Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>~Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>~Prednisone 60 mg/m^2 PO BID on Days 1-5>~Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6."
10828992|NCT00118209|BG002|Baseline|Total|Total of all reporting groups
10828993|NCT00118209|FG000|Participant Flow|Arm A - R-CHOP|"Patients receive the following treatment:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>~Cyclophosphamide 750 mg/m^2 IV on Day 1>~Doxorubicin 50 mg/m^2 IV on Day 1>~Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>~Prednisone 40 mg/m^2/day PO on Days 1-5>~filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6."
10828994|NCT00118209|FG001|Participant Flow|Arm B - DA-EPOCH-R|"Patients receive the following treatment:> Cycle 1 Doses:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>~Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>~Etoposide 50 mg/m^2/day CIVI on Days 1-4>~Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>~Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>~Prednisone 60 mg/m^2 PO BID on Days 1-5>~Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6."
10828995|NCT00118209|OG000|Outcome|Arm B - DA-EPOCH-R|"Patients receive the following treatment:> Cycle 1 Doses:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy>~Doxorubicin 10 mg/m^2/day CIVI on Days 1-4>~Etoposide 50 mg/m^2/day CIVI on Days 1-4>~Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)>~Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions)>~Prednisone 60 mg/m^2 PO BID on Days 1-5>~Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the > nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not > being monitored, during every cycle.> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.> Required ancillary medications are administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6."
10828996|NCT00118209|OG001|Outcome|Arm A - R-CHOP|"Patients receive the following treatment:>~Rituximab 375 mg/m^2 IV infusion on Day 1 prior to CHOP chemotherapy>~Cyclophosphamide 750 mg/m^2 IV on Day 1>~Doxorubicin 50 mg/m^2 IV on Day 1>~Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1>~Prednisone 40 mg/m^2/day PO on Days 1-5>~filgrastim or pegfilgrastim as defined in the protocol> Required ancillary medications is administered during all cycles as defined in the protocol.> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6."
10828997|NCT00118209|EG000|Reported Event|Arm A - R-CHOP|Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
10828998|NCT00118209|EG001|Reported Event|Arm B - DA-EPOCH-R|Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
10828999|NCT00118248|BG000|Baseline|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829000|NCT00118248|BG001|Baseline|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829001|NCT00118248|BG002|Baseline|Total|Total of all reporting groups
10829002|NCT00118248|FG000|Participant Flow|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829003|NCT00118248|FG001|Participant Flow|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829004|NCT00118248|OG000|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829005|NCT00118248|OG001|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829006|NCT00118248|EG000|Reported Event|All Patients|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10829007|NCT00118274|BG000|Baseline|Arm I|"Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously"
10829008|NCT00118274|BG001|Baseline|Arm II|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829009|NCT00118274|BG002|Baseline|Arm III|"Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously"
10829010|NCT00118274|BG003|Baseline|Arm IV|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829011|NCT00118274|BG004|Baseline|Total|Total of all reporting groups
10829012|NCT00118274|FG000|Participant Flow|Arm I|"Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously"
10829013|NCT00118274|FG001|Participant Flow|Arm II|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829014|NCT00118274|FG002|Participant Flow|Arm III|"Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously"
10829015|NCT00118274|FG003|Participant Flow|Arm IV|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10843031|NCT00251641|FG000|Participant Flow|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
11328256|NCT03425396|FG000|Participant Flow|Omadacycline 300/300 Once Every 24 Hours|Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328257|NCT03425396|FG001|Participant Flow|Omadacycline 450/300 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328258|NCT03425396|FG002|Participant Flow|Omadacycline 450/450 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
10829016|NCT00118274|OG000|Outcome|Arm I|"Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously"
10829017|NCT00118274|OG001|Outcome|Arm II|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829018|NCT00118274|OG002|Outcome|Arm III|"Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously"
10829019|NCT00118274|OG003|Outcome|Arm IV|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829020|NCT00118274|EG000|Reported Event|Arm I|"Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously"
10829021|NCT00118274|EG001|Reported Event|Arm II|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~tetanus toxoid helper peptide: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829022|NCT00118274|EG002|Reported Event|Arm III|"Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously"
10829023|NCT00118274|EG003|Reported Event|Arm IV|"Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.~incomplete Freund's adjuvant: Given intradermally and subcutaneously~melanoma helper peptide vaccine: Given intradermally and subcutaneously~multi-epitope melanoma peptide vaccine: Given intradermally and subcutaneously~cyclophosphamide: Given IV"
10829024|NCT00118287|BG000|Baseline|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
10829025|NCT00118287|FG000|Participant Flow|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
10829026|NCT00118287|OG000|Outcome|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
10829027|NCT00118287|EG000|Reported Event|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
10829028|NCT00118352|BG000|Baseline|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829029|NCT00118352|BG001|Baseline|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829030|NCT00118352|BG002|Baseline|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829031|NCT00118352|BG003|Baseline|Total|Total of all reporting groups
10829032|NCT00118352|FG000|Participant Flow|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829033|NCT00118352|FG001|Participant Flow|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
10829034|NCT00118352|FG002|Participant Flow|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
10829035|NCT00118352|OG000|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829036|NCT00118352|OG001|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829037|NCT00118352|OG002|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829038|NCT00118352|EG000|Reported Event|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829039|NCT00118352|EG001|Reported Event|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829040|NCT00118352|EG002|Reported Event|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
10829041|NCT00118365|BG000|Baseline|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829042|NCT00118365|BG001|Baseline|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829043|NCT00118365|BG002|Baseline|Total|Total of all reporting groups
10829044|NCT00118365|FG000|Participant Flow|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829045|NCT00118365|FG001|Participant Flow|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829046|NCT00118365|OG000|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829047|NCT00118365|OG001|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829048|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + Low PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is below the median"
10829049|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + High PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is above the median"
10829050|NCT00118365|OG002|Outcome|Placebo + Low PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is below median"
10829051|NCT00118365|OG003|Outcome|Placebo + High PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is above median"
10829052|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + Low Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is below the median"
10829053|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + High Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is above the median"
10829054|NCT00118365|OG002|Outcome|Placebo + Low Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is below median"
10829055|NCT00118365|OG003|Outcome|Placebo + High Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is above median"
10829056|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + Low Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below the median"
10829057|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + High Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above the median"
10829058|NCT00118365|OG002|Outcome|Placebo + Low Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below median"
10829059|NCT00118365|OG003|Outcome|Placebo + High Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above median"
10829060|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + PGE2 Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
10829061|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + PGE2 Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
10829062|NCT00118365|OG002|Outcome|Placebo + PGE2 Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
10829063|NCT00118365|OG003|Outcome|Placebo + PGE2 Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
10829064|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + Putrescine Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
10829065|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + Putrescine Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
10829066|NCT00118365|OG002|Outcome|Placebo + Putrescine Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
10829067|NCT00118365|OG003|Outcome|Placebo + Putrescine Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
10829068|NCT00118365|OG000|Outcome|Eflornithine and Sulindac + Spd:Spm Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
10829069|NCT00118365|OG001|Outcome|Eflornithine and Sulindac + Spd:Spm Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
10829070|NCT00118365|OG002|Outcome|Placebo + Spd:Spm Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
10829071|NCT00118365|OG003|Outcome|Placebo + Spd:Spm Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
10829072|NCT00118365|OG000|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
10829073|NCT00118365|OG001|Outcome|ODC1 GG|Patients with GG genotype
10829074|NCT00118365|OG000|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829075|NCT00118365|OG001|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829076|NCT00118365|OG002|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829077|NCT00118365|OG003|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829078|NCT00118365|EG000|Reported Event|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
10829079|NCT00118365|EG001|Reported Event|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
10829080|NCT00118378|BG000|Baseline|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
10829081|NCT00118378|BG001|Baseline|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
10829082|NCT00118378|BG002|Baseline|Total|Total of all reporting groups
10829083|NCT00118378|FG000|Participant Flow|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
10829084|NCT00118378|FG001|Participant Flow|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
10829085|NCT00118378|OG000|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
10829086|NCT00118378|OG001|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
10829087|NCT00118378|OG000|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
10829088|NCT00118378|OG001|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
10829089|NCT00118378|EG000|Reported Event|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
10829090|NCT00118378|EG001|Reported Event|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
10829091|NCT00118404|BG000|Baseline|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
10829092|NCT00118404|BG001|Baseline|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
10829093|NCT00118404|BG002|Baseline|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
10829094|NCT00118404|BG003|Baseline|Total|Total of all reporting groups
10829095|NCT00118404|FG000|Participant Flow|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
10829096|NCT00118404|FG001|Participant Flow|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
10829097|NCT00118404|FG002|Participant Flow|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
10829098|NCT00118404|OG000|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
10829099|NCT00118404|OG001|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
10829100|NCT00118404|OG002|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
10829101|NCT00118404|EG000|Reported Event|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
10829102|NCT00118404|EG001|Reported Event|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
10829103|NCT00118404|EG002|Reported Event|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
10829104|NCT00118417|BG000|Baseline|All Participants|
10829105|NCT00118417|FG000|Participant Flow|Sertraline / Increased Dose / Medication Optimization|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
10829106|NCT00118417|FG001|Participant Flow|Sertraline / + Placebo / Cognitive Behavior Therapy Augment.|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
10829107|NCT00118417|OG000|Outcome|Moderate Sertraline Treatment|This group will receive moderate sertraline or escitalopram treatment
10829108|NCT00118417|OG000|Outcome|Increased Sertraline|This group will receive an increased dosage of sertraline or escitalopram
10829109|NCT00118417|OG001|Outcome|Sertraline Plus Placebo|This group will receive sertraline or escitalopram with a placebo
10829110|NCT00118417|OG000|Outcome|Medication Optimization|This group will receive medication optimization, which includes sertraline or escitalopram with clonazepam
10829111|NCT00118417|OG001|Outcome|Augmented Cognitive Behavior Therapy|This group will receive sertraline or escitalopram with cognitive behavioral therapy (CBT)
10829112|NCT00118417|EG000|Reported Event|Phase I: Sertraline|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).
11095243|NCT01557244|BG004|Baseline|Cohort 2: Fesoterodine 2 mg Then 4 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.
10829113|NCT00118417|EG001|Reported Event|Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone|
10829114|NCT00118417|EG002|Reported Event|Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam|
11095244|NCT01557244|BG005|Baseline|Total|Total of all reporting groups
10829115|NCT00118430|BG000|Baseline|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
10829116|NCT00118430|BG001|Baseline|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
10829117|NCT00118430|BG002|Baseline|No Treatment|Participants without depression group
10829118|NCT00118430|BG003|Baseline|Total|Total of all reporting groups
10829119|NCT00118430|FG000|Participant Flow|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response~Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg"
10829120|NCT00118430|FG001|Participant Flow|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
10829121|NCT00118430|FG002|Participant Flow|No Treatment|Participants without depression group
10829122|NCT00118430|OG000|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
10829123|NCT00118430|OG001|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
10829124|NCT00118430|OG002|Outcome|No Treatment|Participants without depression group
10829125|NCT00118430|EG000|Reported Event|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
10829126|NCT00118430|EG001|Reported Event|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
10829127|NCT00118482|BG000|Baseline|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829128|NCT00118482|BG001|Baseline|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829129|NCT00118482|BG002|Baseline|Total|Total of all reporting groups
10829130|NCT00118482|FG000|Participant Flow|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829131|NCT00118482|FG001|Participant Flow|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829132|NCT00118482|OG000|Outcome|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829133|NCT00118482|OG001|Outcome|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829134|NCT00118482|EG000|Reported Event|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829135|NCT00118482|EG001|Reported Event|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
10829136|NCT00118534|BG000|Baseline|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
10829137|NCT00118534|BG001|Baseline|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
10829138|NCT00118534|BG002|Baseline|Total|Total of all reporting groups
10829139|NCT00118534|FG000|Participant Flow|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
10829140|NCT00118534|FG001|Participant Flow|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
10829141|NCT00118534|OG000|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
10829142|NCT00118534|OG001|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
10829143|NCT00118534|OG000|Outcome|Integrated Care|Integration of Smoking Cessation therapy with PTSD therapy.
10829144|NCT00118534|EG000|Reported Event|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
10829145|NCT00118534|EG001|Reported Event|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
10829146|NCT00118703|BG000|Baseline|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829147|NCT00118703|BG001|Baseline|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829148|NCT00118703|BG002|Baseline|Total|Total of all reporting groups
10829149|NCT00118703|FG000|Participant Flow|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829150|NCT00118703|FG001|Participant Flow|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829151|NCT00118703|OG000|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829152|NCT00118703|OG001|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829153|NCT00118703|EG000|Reported Event|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829154|NCT00118703|EG001|Reported Event|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
10829155|NCT00118716|BG000|Baseline|FSC 100/50mcg BID|Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829156|NCT00118716|BG001|Baseline|FP 100mcg BID|Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829157|NCT00118716|BG002|Baseline|Total|Total of all reporting groups
10829158|NCT00118716|FG000|Participant Flow|FSC 100/50 mcg BID|Participants received Fluticasone Propionate/Salmeterol Combination (FSC) 100/50 micrograms (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days
10829159|NCT00118716|FG001|Participant Flow|FP 100 mcg BID|Participants received Fluticasone Propionate (FP) 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829160|NCT00118716|OG000|Outcome|FSC 100/50mcg BID|Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829161|NCT00118716|OG001|Outcome|FP 100mcg BID|Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829162|NCT00118716|EG000|Reported Event|FSC 100/50mcg BID|Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829163|NCT00118716|EG001|Reported Event|FP 100mcg BID|Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
10829164|NCT00118742|BG000|Baseline|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
10829165|NCT00118742|BG001|Baseline|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
10829166|NCT00118742|BG002|Baseline|Total|Total of all reporting groups
10829167|NCT00118742|FG000|Participant Flow|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
10829168|NCT00118742|FG001|Participant Flow|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
10829169|NCT00118742|OG000|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
10829170|NCT00118742|OG001|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
10829171|NCT00118742|EG000|Reported Event|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
10829172|NCT00118742|EG001|Reported Event|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
10829173|NCT00118755|BG000|Baseline|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
10829174|NCT00118755|BG001|Baseline|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
11328259|NCT03425396|FG003|Participant Flow|Omadacycline 450/450 Once Every 12 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328260|NCT03425396|FG004|Participant Flow|Nitrofurantoin 100/100 Once Every 12 Hours|Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328261|NCT03425396|OG000|Outcome|Omadacycline 300/300 Once Every 24 Hours|Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328262|NCT03425396|OG001|Outcome|Omadacycline 450/300 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328263|NCT03425396|OG002|Outcome|Omadacycline 450/450 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328264|NCT03425396|OG003|Outcome|Omadacycline 450/450 Once Every 12 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328265|NCT03425396|OG004|Outcome|Nitrofurantoin 100/100 Once Every 12 Hours|Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328266|NCT03425396|EG000|Reported Event|Omadacycline 300/300 Once Every 24 Hours|Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
10829175|NCT00118755|BG002|Baseline|Total|Total of all reporting groups
10829176|NCT00118755|FG000|Participant Flow|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
10829177|NCT00118755|FG001|Participant Flow|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
11328267|NCT03425396|EG001|Reported Event|Omadacycline 450/300 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328268|NCT03425396|EG002|Reported Event|Omadacycline 450/450 Once Every 24 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328269|NCT03425396|EG003|Reported Event|Omadacycline 450/450 Once Every 12 Hours|Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328270|NCT03425396|EG004|Reported Event|Nitrofurantoin 100/100 Once Every 12 Hours|Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
11328271|NCT03426228|BG000|Baseline|Non-Pregnant|Negative BHCG at 4 weeks
11328272|NCT03426228|BG001|Baseline|Pregnant|Positive BHCG at 4 weeks
11328273|NCT03426228|BG002|Baseline|Total|Total of all reporting groups
11328274|NCT03426228|FG000|Participant Flow|Non-Pregnant|Negative BHCG at 4 weeks
11328275|NCT03426228|FG001|Participant Flow|Pregnant|Positive BHCG at 4 weeks
11328276|NCT03426228|OG000|Outcome|Non-Pregnant|Negative BHCG at 4 weeks
11328277|NCT03426228|OG001|Outcome|Pregnant|Positive BHCG at 4 weeks
11328278|NCT03426228|OG000|Outcome|Pregnant|Positive BHCG at 4 weeks
11328279|NCT03426228|OG001|Outcome|Non-pregnant|Negative BHCG at 4 weeks
11328280|NCT03426228|EG000|Reported Event|Non-Pregnant|Negative BHCG at 4 weeks
11328281|NCT03426228|EG001|Reported Event|Pregnant|Positive BHCG at 4 weeks
10829178|NCT00118755|OG000|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
10829179|NCT00118755|OG001|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
10829180|NCT00118755|EG000|Reported Event|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
10829181|NCT00118755|EG001|Reported Event|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
10829182|NCT00118898|BG000|Baseline|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829183|NCT00118898|BG001|Baseline|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829184|NCT00118898|BG002|Baseline|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829185|NCT00118898|BG003|Baseline|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829186|NCT00118898|BG004|Baseline|Total|Total of all reporting groups
10829187|NCT00118898|FG000|Participant Flow|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829188|NCT00118898|FG001|Participant Flow|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829189|NCT00118898|FG002|Participant Flow|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829190|NCT00118898|FG003|Participant Flow|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829191|NCT00118898|OG000|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829192|NCT00118898|OG001|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829193|NCT00118898|OG002|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829194|NCT00118898|OG003|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829195|NCT00118898|EG000|Reported Event|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829196|NCT00118898|EG001|Reported Event|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829197|NCT00118898|EG002|Reported Event|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
10829198|NCT00118898|EG003|Reported Event|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
10829199|NCT00118911|BG000|Baseline|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
10829200|NCT00118911|BG001|Baseline|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
10829201|NCT00118911|BG002|Baseline|Total|Total of all reporting groups
10829202|NCT00118911|FG000|Participant Flow|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
10829203|NCT00118911|FG001|Participant Flow|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
10829204|NCT00118911|OG000|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
10829205|NCT00118911|OG001|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
10829206|NCT00118911|EG000|Reported Event|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
10829207|NCT00118911|EG001|Reported Event|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
10829208|NCT00119015|BG000|Baseline|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
10829209|NCT00119015|BG001|Baseline|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
10829210|NCT00119015|BG002|Baseline|Total|Total of all reporting groups
10829211|NCT00119015|FG000|Participant Flow|Fluticasone Propionate Only|Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
10829212|NCT00119015|FG001|Participant Flow|Fluticasone Propionate+Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Montelukast - 10 mg po daily"
10829213|NCT00119015|FG002|Participant Flow|Fluticasone Propionate+Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Placebo - 10 mg po daily"
11328282|NCT03426267|BG000|Baseline|SDN-037|SDN-037: twice daily
11328283|NCT03426267|BG001|Baseline|Vehicle|Placebo: twice daily
10829214|NCT00119015|OG000|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
10829215|NCT00119015|OG001|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
10829216|NCT00119015|EG000|Reported Event|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
10829217|NCT00119015|EG001|Reported Event|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
10829218|NCT00119041|BG000|Baseline|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.~We did not collect gender and age related data."
10829219|NCT00119041|BG001|Baseline|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
10829220|NCT00119041|BG002|Baseline|Provider Interview|Qualitative interviews with providers
10829221|NCT00119041|BG003|Baseline|Total|Total of all reporting groups
10829222|NCT00119041|FG000|Participant Flow|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
10829223|NCT00119041|FG001|Participant Flow|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
10829224|NCT00119041|FG002|Participant Flow|Provider Interview|Qualitative interviews with providers
10829225|NCT00119041|OG000|Outcome|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
10829226|NCT00119041|OG001|Outcome|Control CBOC|Received the questionnaires by mail and had no intervention of diabetes teleconference
10829227|NCT00119041|OG000|Outcome|Telemedicine|Intervention group
10829228|NCT00119041|OG001|Outcome|Control|non intervention group
10829229|NCT00119041|EG000|Reported Event|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
10829230|NCT00119041|EG001|Reported Event|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
10829231|NCT00119041|EG002|Reported Event|Provider Interviews|Qualitative interviews with providers.
10829232|NCT00119106|BG000|Baseline|Tenofovir|"Tenofovir~Tenofovir"
10829233|NCT00119106|BG001|Baseline|Placebo|"Placebo~Tenofovir"
10829234|NCT00119106|BG002|Baseline|Total|Total of all reporting groups
10829235|NCT00119106|FG000|Participant Flow|Tenofovir|"Tenofovir~Tenofovir"
10829236|NCT00119106|FG001|Participant Flow|Placebo|"Placebo~Tenofovir"
10829237|NCT00119106|OG000|Outcome|Tenofovir|
10829238|NCT00119106|OG001|Outcome|Placebo|
10829239|NCT00119106|OG000|Outcome|Tenofovir|"Tenofovir~Tenofovir"
10829240|NCT00119106|OG001|Outcome|Placebo|"Placebo~Tenofovir"
10829241|NCT00119106|OG000|Outcome|Tenofovir|Received tenofovir
10829242|NCT00119106|OG001|Outcome|Placebo|Received placebo
10829243|NCT00119106|OG000|Outcome|Tenofovir Group|Tenofovir participants
10829244|NCT00119106|OG001|Outcome|Placebo Group|Placebo recipients
10829245|NCT00119106|OG000|Outcome|Tenofovir|Participants
10829246|NCT00119106|OG001|Outcome|Placebo|Participants
10829247|NCT00119106|EG000|Reported Event|Tenofovir|"Tenofovir~Tenofovir"
10829248|NCT00119106|EG001|Reported Event|Placebo|"Placebo~Tenofovir"
10829249|NCT00119158|BG000|Baseline|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829250|NCT00119158|BG001|Baseline|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829251|NCT00119158|BG002|Baseline|Total|Total of all reporting groups
10829252|NCT00119158|FG000|Participant Flow|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829253|NCT00119158|FG001|Participant Flow|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829254|NCT00119158|OG000|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829255|NCT00119158|OG001|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829256|NCT00119158|EG000|Reported Event|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829257|NCT00119158|EG001|Reported Event|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
10829258|NCT00119262|BG000|Baseline|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829259|NCT00119262|BG001|Baseline|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829260|NCT00119262|BG002|Baseline|Total|Total of all reporting groups
10829261|NCT00119262|FG000|Participant Flow|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829262|NCT00119262|FG001|Participant Flow|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829263|NCT00119262|OG000|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829264|NCT00119262|OG001|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829265|NCT00119262|EG000|Reported Event|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829266|NCT00119262|EG001|Reported Event|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
10829267|NCT00119379|BG000|Baseline|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
10829268|NCT00119379|BG001|Baseline|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
10829269|NCT00119379|BG002|Baseline|Total|Total of all reporting groups
10829270|NCT00119379|FG000|Participant Flow|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
10829271|NCT00119379|FG001|Participant Flow|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
10829272|NCT00119379|OG000|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
10829273|NCT00119379|OG001|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
10829274|NCT00119379|EG000|Reported Event|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
10829275|NCT00119379|EG001|Reported Event|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
10829276|NCT00119392|BG000|Baseline|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
10829277|NCT00119392|FG000|Participant Flow|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
10829278|NCT00119392|OG000|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
10829279|NCT00119392|EG000|Reported Event|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
11328284|NCT03426267|BG002|Baseline|Total|Total of all reporting groups
11328285|NCT03426267|FG000|Participant Flow|SDN-037|"dosage: SDN-037~dosage form: solution~frequency of administration: twice daily"
10829280|NCT00119405|BG000|Baseline|ARV Naive|ARV naive
10829281|NCT00119405|FG000|Participant Flow|ARV Naive|ARV naive
10829282|NCT00119405|OG000|Outcome|ARV Naive|ARV naive (have never been on antiretrovirals before)
10829283|NCT00119405|EG000|Reported Event|ARV Naive|ARV naive (have never been on antiretrovirals before)
10829284|NCT00119678|BG000|Baseline|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829285|NCT00119678|BG001|Baseline|Placebo|"Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829286|NCT00119678|BG002|Baseline|Total|Total of all reporting groups
10829287|NCT00119678|FG000|Participant Flow|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829288|NCT00119678|FG001|Participant Flow|Placebo|"Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829289|NCT00119678|OG000|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829290|NCT00119678|OG001|Outcome|Placebo|"Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829291|NCT00119678|OG000|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
10843032|NCT00251641|FG001|Participant Flow|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
10843033|NCT00251641|OG000|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
11328286|NCT03426267|FG001|Participant Flow|Vehicle|"dosage: Placebo~dosage form: solution~frequency of administration: twice daily"
10829292|NCT00119678|OG000|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved."
10829293|NCT00119678|EG000|Reported Event|Abatacept|"Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829294|NCT00119678|EG001|Reported Event|Placebo|"Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
10829295|NCT00120250|BG000|Baseline|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
10829296|NCT00120250|FG000|Participant Flow|Eszopiclone, Then Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
10829297|NCT00120250|FG001|Participant Flow|Placebo, Then Eszopiclone|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
10829298|NCT00120250|OG000|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
10829299|NCT00120250|OG001|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
10829300|NCT00120250|OG000|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
10829301|NCT00120250|OG001|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
10829302|NCT00120250|EG000|Reported Event|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
10829303|NCT00120289|BG000|Baseline|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829304|NCT00120289|BG001|Baseline|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829305|NCT00120289|BG002|Baseline|Total|Total of all reporting groups
10829306|NCT00120289|FG000|Participant Flow|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829307|NCT00120289|FG001|Participant Flow|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829308|NCT00120289|OG000|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829309|NCT00120289|OG001|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829310|NCT00120289|EG000|Reported Event|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829311|NCT00120289|EG001|Reported Event|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
10829312|NCT00120406|BG000|Baseline|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
10829313|NCT00120406|BG001|Baseline|PTA (Control)|Percutaneous balloon angioplasty
10829314|NCT00120406|BG002|Baseline|Total|Total of all reporting groups
10829315|NCT00120406|FG000|Participant Flow|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
10829316|NCT00120406|FG001|Participant Flow|PTA (Control)|Percutaneous balloon angioplasty
10829317|NCT00120406|OG000|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
10829318|NCT00120406|OG001|Outcome|PTA (Control)|Percutaneous balloon angioplasty
10829319|NCT00120406|EG000|Reported Event|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
10829320|NCT00120406|EG001|Reported Event|PTA (Control)|Percutaneous balloon angioplasty
10829321|NCT00120523|BG000|Baseline|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
10829322|NCT00120523|BG001|Baseline|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
10829323|NCT00120523|BG002|Baseline|Total|Total of all reporting groups
10829324|NCT00120523|FG000|Participant Flow|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
10829325|NCT00120523|FG001|Participant Flow|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
10829326|NCT00120523|OG000|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
10829327|NCT00120523|OG001|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
10829328|NCT00120523|OG000|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
10829329|NCT00120523|EG000|Reported Event|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
10829330|NCT00120523|EG001|Reported Event|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
10829331|NCT00120627|BG000|Baseline|Treatment Arm: Mantram + Medication & Case Management|"Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states."
10829332|NCT00120627|BG001|Baseline|Control Arm: Medication & Case Management Alone|"Usual care consisting of medication and case-management.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
10829333|NCT00120627|BG002|Baseline|Total|Total of all reporting groups
10829334|NCT00120627|FG000|Participant Flow|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829335|NCT00120627|FG001|Participant Flow|Arm 2: Usual Care|"Usual care consisting of medication and case-management.~Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed."
10829336|NCT00120627|OG000|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829337|NCT00120627|OG001|Outcome|Arm 2: Medication & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
11328287|NCT03426267|OG000|Outcome|SDN-037|SDN-037: twice daily
11328288|NCT03426267|OG001|Outcome|Vehicle|Placebo: twice daily
11328289|NCT03426267|EG000|Reported Event|SDN-037|SDN-037: twice daily
11095245|NCT01557244|FG000|Participant Flow|Cohort 1: Fesoterodine 4 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 milligram (mg) prolonged release (PR) tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.
10829338|NCT00120627|OG000|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829339|NCT00120627|OG001|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
10829340|NCT00120627|OG000|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.."
10829341|NCT00120627|OG000|Outcome|Arm 1: Mantram + Meds & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829342|NCT00120627|OG001|Outcome|Arm 2: Meds & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
10829343|NCT00120627|OG000|Outcome|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829344|NCT00120627|OG001|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
10829345|NCT00120627|OG000|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources."
10829346|NCT00120627|OG000|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
10829347|NCT00120627|EG000|Reported Event|Arm 1|"he MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
10829348|NCT00120627|EG001|Reported Event|Arm 2|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
11328290|NCT03426267|EG001|Reported Event|Vehicle|Placebo: twice daily
10829349|NCT00120874|BG000|Baseline|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829350|NCT00120874|BG001|Baseline|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829351|NCT00120874|BG002|Baseline|Total|Total of all reporting groups
10829352|NCT00120874|FG000|Participant Flow|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829353|NCT00120874|FG001|Participant Flow|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829354|NCT00120874|OG000|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829355|NCT00120874|OG001|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829356|NCT00120874|EG000|Reported Event|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829357|NCT00120874|EG001|Reported Event|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
10829358|NCT00121134|BG000|Baseline|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
10829359|NCT00121134|BG001|Baseline|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
10829360|NCT00121134|BG002|Baseline|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
10829361|NCT00121134|BG003|Baseline|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
10829362|NCT00121134|BG004|Baseline|Total|Total of all reporting groups
10829363|NCT00121134|FG000|Participant Flow|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
10829364|NCT00121134|FG001|Participant Flow|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
10829365|NCT00121134|FG002|Participant Flow|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
10829366|NCT00121134|FG003|Participant Flow|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
10829367|NCT00121134|OG000|Outcome|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
10829368|NCT00121134|OG001|Outcome|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
10829369|NCT00121134|OG002|Outcome|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
10829370|NCT00121134|OG003|Outcome|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
10829371|NCT00121134|EG000|Reported Event|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
11328291|NCT03426345|BG000|Baseline|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
10829372|NCT00121134|EG001|Reported Event|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
10829373|NCT00121134|EG002|Reported Event|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
10829374|NCT00121134|EG003|Reported Event|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
10829375|NCT00121173|BG000|Baseline|Low Dose|"3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829376|NCT00121173|BG001|Baseline|Intermediate Dose|"3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829377|NCT00121173|BG002|Baseline|High Dose|"3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829378|NCT00121173|BG003|Baseline|Total|Total of all reporting groups
11328292|NCT03426345|BG001|Baseline|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
11328293|NCT03426345|BG002|Baseline|Total|Total of all reporting groups
10829379|NCT00121173|FG000|Participant Flow|Low Dose|"3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829380|NCT00121173|FG001|Participant Flow|Intermediate Dose|"3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829381|NCT00121173|FG002|Participant Flow|High Dose|"3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829382|NCT00121173|OG000|Outcome|Low Dose|"3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829383|NCT00121173|OG001|Outcome|Intermediate Dose|"3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829384|NCT00121173|OG002|Outcome|High Dose|"3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829385|NCT00121173|OG000|Outcome|Low Dose|"3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals.~Genetic (recombinant DNA vaccine)~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine"
10829386|NCT00121173|OG001|Outcome|Intermediate Dose|"3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine"
10829387|NCT00121173|OG002|Outcome|High Dose|"3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine: recombinant DNA vaccine"
10829388|NCT00121173|EG000|Reported Event|Low Dose|"3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829389|NCT00121173|EG001|Reported Event|Intermediate Dose|"3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829390|NCT00121173|EG002|Reported Event|High Dose|"3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM~pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine"
10829391|NCT00121186|BG000|Baseline|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
10829392|NCT00121186|FG000|Participant Flow|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
10829393|NCT00121186|OG000|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
10829394|NCT00121186|EG000|Reported Event|Nonmyeloablative Allogeneic Stem Cell Transplant|
10829395|NCT00121199|BG000|Baseline|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
10829396|NCT00121199|FG000|Participant Flow|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
10829397|NCT00121199|OG000|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
10829398|NCT00121199|EG000|Reported Event|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
10829399|NCT00121225|BG000|Baseline|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
10829400|NCT00121225|FG000|Participant Flow|Arm 1 Vorinostat|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
10829401|NCT00121225|OG000|Outcome|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
10829402|NCT00121225|OG000|Outcome|Arm 1 Vorinostat|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
10829403|NCT00121225|EG000|Reported Event|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
10829404|NCT00121238|BG000|Baseline|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
11328294|NCT03426345|FG000|Participant Flow|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11328295|NCT03426345|FG001|Participant Flow|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
11328296|NCT03426345|OG000|Outcome|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
11328297|NCT03426345|OG001|Outcome|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
10829405|NCT00121238|FG000|Participant Flow|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
10829406|NCT00121238|OG000|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
10829407|NCT00121238|EG000|Reported Event|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
10829408|NCT00121251|BG000|Baseline|Sorafenib + Gemcitabine + Capecitabine|"Patients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.~Capecitabine: Given PO~Gemcitabine Hydrochloride: Given IV~Sorafenib Tosylate: Given PO"
10829409|NCT00121251|FG000|Participant Flow|Sorafenib + Gemcitabine + Capecitabine|"Patients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.~Capecitabine: Given PO~Gemcitabine Hydrochloride: Given IV~Sorafenib Tosylate: Given PO"
10829410|NCT00121251|OG000|Outcome|Sorafenib + Gemcitabine + Capecitabine|"Patients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.~Capecitabine: Given PO~Gemcitabine Hydrochloride: Given IV~Sorafenib Tosylate: Given PO"
10829411|NCT00121251|EG000|Reported Event|Sorafenib + Gemcitabine + Capecitabine|"Patients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.~Capecitabine: Given PO~Gemcitabine Hydrochloride: Given IV~Sorafenib Tosylate: Given PO"
11328298|NCT03426345|OG000|Outcome|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
10829430|NCT00121641|BG000|Baseline|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829431|NCT00121641|BG001|Baseline|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
11328299|NCT03426345|EG000|Reported Event|Placebo|Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
10829432|NCT00121641|BG002|Baseline|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829433|NCT00121641|BG003|Baseline|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
10829434|NCT00121641|BG004|Baseline|Total|Total of all reporting groups
10829435|NCT00121641|FG000|Participant Flow|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue).
10829436|NCT00121641|FG001|Participant Flow|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829437|NCT00121641|FG002|Participant Flow|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829438|NCT00121641|FG003|Participant Flow|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
10829439|NCT00121641|FG004|Participant Flow|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829440|NCT00121641|OG000|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829441|NCT00121641|OG001|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829442|NCT00121641|OG002|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829443|NCT00121641|OG003|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
10829444|NCT00121641|OG000|Outcome|Open-Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829445|NCT00121641|OG000|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829446|NCT00121641|OG000|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829447|NCT00121641|EG000|Reported Event|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829448|NCT00121641|EG001|Reported Event|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
10829449|NCT00121641|EG002|Reported Event|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829450|NCT00121641|EG003|Reported Event|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829451|NCT00121641|EG004|Reported Event|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
10829452|NCT00121667|BG000|Baseline|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829453|NCT00121667|BG001|Baseline|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829454|NCT00121667|BG002|Baseline|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829455|NCT00121667|BG003|Baseline|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829456|NCT00121667|BG004|Baseline|Total|Total of all reporting groups
10829457|NCT00121667|FG000|Participant Flow|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829458|NCT00121667|FG001|Participant Flow|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829459|NCT00121667|FG002|Participant Flow|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829460|NCT00121667|FG003|Participant Flow|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829461|NCT00121667|OG000|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829462|NCT00121667|OG001|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829463|NCT00121667|OG002|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829464|NCT00121667|OG003|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829465|NCT00121667|EG000|Reported Event|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829466|NCT00121667|EG001|Reported Event|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829467|NCT00121667|EG002|Reported Event|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
10829468|NCT00121667|EG003|Reported Event|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
11328300|NCT03426345|EG001|Reported Event|Relamorelin 10 μg|Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
10829469|NCT00121719|BG000|Baseline|Lenvatinib 0.2 mg|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
10829470|NCT00121719|BG001|Baseline|Lenvatinib 0.4 mg|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829471|NCT00121719|BG002|Baseline|Lenvatinib 0.8 mg|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829472|NCT00121719|BG003|Baseline|Lenvatinib 1.6 mg|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829473|NCT00121719|BG004|Baseline|Lenvatinib 3.2 mg|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829474|NCT00121719|BG005|Baseline|Lenvatinib 6.4 mg|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829475|NCT00121719|BG006|Baseline|Lenvatinib 12 mg|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829476|NCT00121719|BG007|Baseline|Lenvatinib 12.5 mg|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10843034|NCT00251641|OG001|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
10829477|NCT00121719|BG008|Baseline|Lenvatinib 16 mg|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829478|NCT00121719|BG009|Baseline|Lenvatinib 20 mg|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829479|NCT00121719|BG010|Baseline|Lenvatinib (MTD Cohort) 25 mg|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829480|NCT00121719|BG011|Baseline|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829481|NCT00121719|BG012|Baseline|Total|Total of all reporting groups
10829482|NCT00121719|FG000|Participant Flow|Lenvatinib 0.2 mg|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
10829483|NCT00121719|FG001|Participant Flow|Lenvatinib 0.4 mg|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829484|NCT00121719|FG002|Participant Flow|Lenvatinib 0.8 mg|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10843035|NCT00251641|EG000|Reported Event|Infliximab|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
10843036|NCT00251641|EG001|Reported Event|Methotrexate|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
10843037|NCT00251641|EG002|Reported Event|Participants Who Switched From Infliximab to Methotrexate|Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
11336062|NCT03560245|EG001|Reported Event|Placebo|"Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.~The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.~Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug"
10829485|NCT00121719|FG003|Participant Flow|Lenvatinib 1.6 mg|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829486|NCT00121719|FG004|Participant Flow|Lenvatinib 3.2 mg|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829487|NCT00121719|FG005|Participant Flow|Lenvatinib 6.4 mg|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829488|NCT00121719|FG006|Participant Flow|Lenvatinib 12 mg|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829489|NCT00121719|FG007|Participant Flow|Lenvatinib 12.5 mg|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829490|NCT00121719|FG008|Participant Flow|Lenvatinib 16 mg|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829491|NCT00121719|FG009|Participant Flow|Lenvatinib 20 mg|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829492|NCT00121719|FG010|Participant Flow|Lenvatinib Fasted/Fed 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829493|NCT00121719|FG011|Participant Flow|Lenvatinib Fed/Fasted 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
11336063|NCT03560518|BG000|Baseline|Placebo|Placebo (prefilled syringe, weekly IV administration)
11336064|NCT03560518|BG001|Baseline|Rapastinel 450mg|Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
11336065|NCT03560518|BG002|Baseline|Rapastinel 900mg|Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
11336066|NCT03560518|BG003|Baseline|Total|Total of all reporting groups
11336067|NCT03560518|FG000|Participant Flow|Placebo|Placebo (prefilled syringe, weekly IV administration)
11336068|NCT03560518|FG001|Participant Flow|Rapastinel 450mg|Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
11336069|NCT03560518|FG002|Participant Flow|Rapastinel 900mg|Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
11336070|NCT03560518|OG000|Outcome|Placebo|Placebo (prefilled syringe, weekly IV administration)
11336071|NCT03560518|OG001|Outcome|Rapastinel 450mg|Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
11336072|NCT03560518|OG002|Outcome|Rapastinel 900mg|Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
11336073|NCT03560518|EG000|Reported Event|Placebo|Placebo (prefilled syringe, weekly IV administration)
11336074|NCT03560518|EG001|Reported Event|Rapastinel 450mg|Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
11336075|NCT03560518|EG002|Reported Event|Rapastinel 900mg|Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
11336076|NCT03560739|BG000|Baseline|OMB 20mg AI Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
11336077|NCT03560739|BG001|Baseline|OMB 20mg PFS Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
11336078|NCT03560739|BG002|Baseline|OMB 20mg AI Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
11336079|NCT03560739|BG003|Baseline|OMB 20mg PFS Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
11336080|NCT03560739|BG004|Baseline|Total|Total of all reporting groups
11336081|NCT03560739|FG000|Participant Flow|OMB 20mg AI Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
11336082|NCT03560739|FG001|Participant Flow|OMB 20mg PFS Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
11336083|NCT03560739|FG002|Participant Flow|OMB 20mg AI Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
11336084|NCT03560739|FG003|Participant Flow|OMB 20mg PFS Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
11336085|NCT03560739|OG000|Outcome|OMB 20mg AI Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
11336086|NCT03560739|OG001|Outcome|OMB 20mg PFS Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
11336087|NCT03560739|OG002|Outcome|OMB 20mg AI Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
11336088|NCT03560739|OG003|Outcome|OMB 20mg PFS Thigh|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
11336089|NCT03560739|EG000|Reported Event|OMB 20mg AI (ABD)|Ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on abdomen
11336090|NCT03560739|EG001|Reported Event|OMB 20mg PFS Abdomen|Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
11336091|NCT03560739|EG002|Reported Event|OMB 20mg AI (THI)|Ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on thigh
11336092|NCT03560739|EG003|Reported Event|OMB 20mg PFS (THI)|Ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on thigh
11336093|NCT03560869|BG000|Baseline|All Study Participants|All Study Participants
11336094|NCT03560869|FG000|Participant Flow|Normal Hydration Than Dehydration|14 participants consumed water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 2).
11336095|NCT03560869|FG001|Participant Flow|Dehydration Than Normal Hydration|21 participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants consumed water to maintain proper hydration for three days prior to testing (visit 2).
11336096|NCT03560869|OG000|Outcome|Normal Hydration|"Participants will consume water to maintain proper hydration for three days prior to testing.~Hydration State: Hydration State"
11336097|NCT03560869|OG001|Outcome|Dehydration|"Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.~Hydration State: Hydration State"
11336098|NCT03560869|EG000|Reported Event|Normal Hydration|"Participants will consume water to maintain proper hydration for three days prior to testing.~Hydration State: Hydration State"
11336099|NCT03560869|EG001|Reported Event|Dehydration|"Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.~Hydration State: Hydration State"
11336100|NCT03560986|BG000|Baseline|Neridronic Acid - Treatment Period A|Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11336101|NCT03560986|BG001|Baseline|Placebo - Treatment Period A|Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11336102|NCT03560986|BG002|Baseline|Total|Total of all reporting groups
11336103|NCT03560986|FG000|Participant Flow|Neridronic Acid - Treatment Period A|"Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.~Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks."
11336104|NCT03560986|FG001|Participant Flow|Placebo - Treatment Period A|"Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.~Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks."
11336105|NCT03560986|OG000|Outcome|Neridronic Acid - Treatment Period A|Neridronic acid 100 mg - 4 intravenous infusions within 10 Days
11336106|NCT03560986|OG001|Outcome|Placebo - Treatment Period A|Matching placebo - 4 intravenous infusions within 10 Days
11336107|NCT03560986|OG000|Outcome|Neridronic Acid - Treatment Period A|Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.
10843038|NCT00251641|EG003|Reported Event|Participants Who Switched From Methotrexate to Infliximab|Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
10829494|NCT00121719|FG012|Participant Flow|Lenvatinib (MTD Cohort) 25 mg|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829495|NCT00121719|FG013|Participant Flow|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829496|NCT00121719|OG000|Outcome|Lenvatinib|"Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.~Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib."
10829497|NCT00121719|OG000|Outcome|Lenvatinib 0.2 mg|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829498|NCT00121719|OG001|Outcome|Lenvatinib 0.4 mg|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829499|NCT00121719|OG002|Outcome|Lenvatinib 0.8 mg|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829500|NCT00121719|OG003|Outcome|Lenvatinib 1.6 mg|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829501|NCT00121719|OG004|Outcome|Lenvatinib 3.2 mg|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10843039|NCT00251693|BG000|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10843040|NCT00251693|BG001|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843041|NCT00251693|BG002|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843042|NCT00251693|BG003|Baseline|Total|Total of all reporting groups
10829502|NCT00121719|OG005|Outcome|Lenvatinib 6.4 mg|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829503|NCT00121719|OG006|Outcome|Lenvatinib 12 mg|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829504|NCT00121719|OG007|Outcome|Lenvatinib 12.5 mg|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829505|NCT00121719|OG008|Outcome|Lenvatinib 16 mg|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829506|NCT00121719|OG009|Outcome|Lenvatinib 20 mg|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829507|NCT00121719|OG010|Outcome|Lenvatinib Fasted/Fed 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829508|NCT00121719|OG011|Outcome|Lenvatinib Fed/Fasted 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829509|NCT00121719|OG012|Outcome|Lenvatinib (MTD Cohort) 25 mg|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829510|NCT00121719|OG013|Outcome|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10843043|NCT00251693|FG000|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10829511|NCT00121719|OG000|Outcome|Lenvatinib 0.2 mg|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
10829512|NCT00121719|OG010|Outcome|Lenvatinib (MTD Cohort) 25 mg|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829513|NCT00121719|OG011|Outcome|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829514|NCT00121719|OG000|Outcome|Lenvatinib 0.2 - 6.4 mg|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
10829515|NCT00121719|OG001|Outcome|Lenvatinib 12 - 20 mg|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
10829516|NCT00121719|OG002|Outcome|Lenvatinib 25 mg|Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
10829517|NCT00121719|OG003|Outcome|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
10829518|NCT00121719|OG000|Outcome|Lenvatinib Fed 25 mg|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829519|NCT00121719|OG001|Outcome|Lenvatinib Fasted 25 mg|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829520|NCT00121719|OG000|Outcome|Lenvatinib Fed State 25 mg|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829521|NCT00121719|OG001|Outcome|Lenvatinib Fasted State 25 mg|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829522|NCT00121719|EG000|Reported Event|Lenvatinib 0.2 mg|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
10829523|NCT00121719|EG001|Reported Event|Lenvatinib 0.4 mg|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829524|NCT00121719|EG002|Reported Event|Lenvatinib 0.8 mg|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829525|NCT00121719|EG003|Reported Event|Lenvatinib 1.6 mg|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829526|NCT00121719|EG004|Reported Event|Lenvatinib 3.2 mg|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829527|NCT00121719|EG005|Reported Event|Lenvatinib 6.4 mg|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
10829528|NCT00121719|EG006|Reported Event|Lenvatinib 12 mg|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829529|NCT00121719|EG007|Reported Event|Lenvatinib 12.5 mg|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829530|NCT00121719|EG008|Reported Event|Lenvatinib 16 mg|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10843044|NCT00251693|FG001|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843045|NCT00251693|FG002|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843046|NCT00251693|OG000|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10829531|NCT00121719|EG009|Reported Event|Lenvatinib 20 mg|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829532|NCT00121719|EG010|Reported Event|Lenvatinib Fasted/Fed 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829533|NCT00121719|EG011|Reported Event|Lenvatinib Fed/Fasted 25 mg|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
10829534|NCT00121719|EG012|Reported Event|Lenvatinib (MTD Cohort) 25 mg|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829535|NCT00121719|EG013|Reported Event|Lenvatinib 32 mg|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
10829536|NCT00121810|BG000|Baseline|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
10829537|NCT00121810|BG001|Baseline|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
10829538|NCT00121810|BG002|Baseline|Total|Total of all reporting groups
10829539|NCT00121810|FG000|Participant Flow|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
10829540|NCT00121810|FG001|Participant Flow|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
10829541|NCT00121810|OG000|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
10829542|NCT00121810|OG001|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
10829543|NCT00121810|EG000|Reported Event|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
10829544|NCT00121810|EG001|Reported Event|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
10829545|NCT00121836|BG000|Baseline|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
10843047|NCT00251693|OG001|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843048|NCT00251693|OG002|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843049|NCT00251693|EG000|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10843050|NCT00251693|EG001|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843051|NCT00251693|EG002|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843052|NCT00251719|BG000|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10829546|NCT00121836|FG000|Participant Flow|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
10829547|NCT00121836|OG000|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
10829548|NCT00121836|OG001|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
10829549|NCT00121836|EG000|Reported Event|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
10829550|NCT00121992|BG000|Baseline|Arm A: FAC|"FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~5-fluorouracil~Doxorubicin~Cyclophosphamide"
10829551|NCT00121992|BG001|Baseline|Arm B: TAC|"TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~Docetaxel~Doxorubicin~Cyclophosphamide"
10829552|NCT00121992|BG002|Baseline|Total|Total of all reporting groups
10829553|NCT00121992|FG000|Participant Flow|Arm A: FAC|"FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~5-fluorouracil~Doxorubicin~Cyclophosphamide"
10829554|NCT00121992|FG001|Participant Flow|Arm B: TAC|"TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~Docetaxel~Doxorubicin~Cyclophosphamide"
10829555|NCT00121992|OG000|Outcome|Arm A: FAC|"FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~5-fluorouracil~Doxorubicin~Cyclophosphamide"
10829556|NCT00121992|OG001|Outcome|Arm B: TAC|"TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~Docetaxel~Doxorubicin~Cyclophosphamide"
10829557|NCT00121992|EG000|Reported Event|Arm A: FAC|"FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~5-fluorouracil~Doxorubicin~Cyclophosphamide"
10829558|NCT00121992|EG001|Reported Event|Arm B: TAC|"TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv~Docetaxel~Doxorubicin~Cyclophosphamide"
10829559|NCT00122109|BG000|Baseline|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829560|NCT00122109|BG001|Baseline|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
10829561|NCT00122109|BG002|Baseline|Total|Total of all reporting groups
10829562|NCT00122109|FG000|Participant Flow|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829563|NCT00122109|FG001|Participant Flow|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829564|NCT00122109|OG000|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
10829565|NCT00122109|OG001|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
10829566|NCT00122109|OG000|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829567|NCT00122109|OG001|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via the traditional face to face modality as compared to the control condition which is the experimental videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829568|NCT00122109|OG001|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
10829569|NCT00122109|EG000|Reported Event|Videoteleconferencing AMT|"The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829570|NCT00122109|EG001|Reported Event|Face to Face AMT|"The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
10829571|NCT00122135|BG000|Baseline|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
10829572|NCT00122135|BG001|Baseline|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
10829573|NCT00122135|BG002|Baseline|Total|Total of all reporting groups
10829574|NCT00122135|FG000|Participant Flow|Patients With VI|"patients / surrogates who did receive the Values Inventory prior to their clinic appointment~Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
10829575|NCT00122135|FG001|Participant Flow|Patients Without VI|Patients who did not receive the Values Inventory prior to their clinic visit
10829576|NCT00122135|OG000|Outcome|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
10829577|NCT00122135|OG001|Outcome|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
10829578|NCT00122135|EG000|Reported Event|Patients With VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
10829579|NCT00122135|EG001|Reported Event|Patients Without VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
10829580|NCT00122187|BG000|Baseline|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
10829581|NCT00122187|BG001|Baseline|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
10829582|NCT00122187|BG002|Baseline|Total|Total of all reporting groups
10829583|NCT00122187|FG000|Participant Flow|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
10829584|NCT00122187|FG001|Participant Flow|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
10829585|NCT00122187|OG000|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
10829586|NCT00122187|OG001|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
10829587|NCT00122187|OG002|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
10829588|NCT00122187|OG003|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
10829589|NCT00122187|EG000|Reported Event|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
10829590|NCT00122187|EG001|Reported Event|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
10829591|NCT00122278|BG000|Baseline|Dexamethasone|"Dexamethasone 10 mg~Dexamethasone: Dexamethasone 10mg IV"
10829592|NCT00122278|BG001|Baseline|Placebo|"Placebo Dexamethasone, 10 mg~Placebo: Placebo Dexamethasone 10mg IV"
10829593|NCT00122278|BG002|Baseline|Total|Total of all reporting groups
10829594|NCT00122278|FG000|Participant Flow|Dexamethasone|"Dexamethasone 10 mg~Dexamethasone: Dexamethasone 10mg IV"
10829595|NCT00122278|FG001|Participant Flow|Placebo|"Placebo Dexamethasone, 10 mg~Placebo: Placebo Dexamethasone 10mg IV"
10829596|NCT00122278|OG000|Outcome|Dexamethasone|"Dexamethasone 10 mg~Dexamethasone: Dexamethasone 10mg IV"
10829597|NCT00122278|OG001|Outcome|Placebo|"Placebo Dexamethasone, 10 mg~Placebo: Placebo Dexamethasone 10mg IV"
10829598|NCT00122278|EG000|Reported Event|Dexamethasone|"Dexamethasone 10 mg~Dexamethasone: Dexamethasone 10mg IV"
10829599|NCT00122278|EG001|Reported Event|Placebo|"Placebo Dexamethasone, 10 mg~Placebo: Placebo Dexamethasone 10mg IV"
10829600|NCT00122317|BG000|Baseline|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
10829601|NCT00122317|FG000|Participant Flow|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
10829602|NCT00122317|OG000|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
10829603|NCT00122317|EG000|Reported Event|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
10829604|NCT00122369|BG000|Baseline|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
10829605|NCT00122369|BG001|Baseline|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
10829606|NCT00122369|BG002|Baseline|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
10829607|NCT00122369|BG003|Baseline|Total|Total of all reporting groups
10829608|NCT00122369|FG000|Participant Flow|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
10829609|NCT00122369|FG001|Participant Flow|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
10829610|NCT00122369|FG002|Participant Flow|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
10829611|NCT00122369|OG000|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
10829612|NCT00122369|OG001|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
10829613|NCT00122369|OG002|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
10829614|NCT00122369|OG000|Outcome|Known Benign Disease|Women who were diagnosed to have benign disease
10829615|NCT00122369|OG001|Outcome|Known Malignant Disease|Women who were diagnosed to have malignant disease
10829616|NCT00122369|OG002|Outcome|Uncertain Diagnosis|"were in the uncertain diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1)."
10829617|NCT00122369|EG000|Reported Event|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
10829618|NCT00122369|EG001|Reported Event|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
10829619|NCT00122369|EG002|Reported Event|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
10829620|NCT00122382|BG000|Baseline|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
10829621|NCT00122382|BG001|Baseline|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
10829622|NCT00122382|BG002|Baseline|Total|Total of all reporting groups
10829623|NCT00122382|FG000|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12 (end of double blind period).
10829624|NCT00122382|FG001|Participant Flow|Placebo (PLA) + Methotrexate (MTX) (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX) titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12 (end of double blind period).
10829625|NCT00122382|FG002|Participant Flow|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with weekly oral MTX were administered every 28 days from Month 12 to Month 24 (open-label period).
10829626|NCT00122382|OG000|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
10843053|NCT00251719|BG001|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10829627|NCT00122382|OG001|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
10829628|NCT00122382|OG000|Outcome|ABA+ MTX On-treatment|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
10829629|NCT00122382|OG001|Outcome|ABA + MTX Post-discontinuation|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
10829630|NCT00122382|OG000|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
10829631|NCT00122382|OG000|Outcome|ABA + MTX (Open Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
10829632|NCT00122382|OG000|Outcome|Anti-Abatacept Antibody Response|
10829633|NCT00122382|OG001|Outcome|Anti-CTLA4-T Antibody Response|
10829634|NCT00122382|OG000|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
10829635|NCT00122382|OG001|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
10829636|NCT00122382|OG001|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
10829637|NCT00122382|OG000|Outcome|ABA + MTX (Open-label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
10829638|NCT00122382|OG000|Outcome|Year 1 Change|Year 1 Change = Day 365 - Day 1
10829639|NCT00122382|OG001|Outcome|Year 2 Change|Year 2 Change = Day 729 (Month 24) - Day 365 (Month 12)
10829640|NCT00122382|EG000|Reported Event|Abatacept|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
11336108|NCT03560986|OG001|Outcome|Placebo - Treatment Period A|Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.
10829641|NCT00122382|EG001|Reported Event|Placebo|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
10829642|NCT00122447|BG000|Baseline|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
10829643|NCT00122447|BG001|Baseline|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
10829644|NCT00122447|BG002|Baseline|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
10829645|NCT00122447|BG003|Baseline|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
10829646|NCT00122447|BG004|Baseline|Total|Total of all reporting groups
10829647|NCT00122447|FG000|Participant Flow|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
10829648|NCT00122447|FG001|Participant Flow|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
10829649|NCT00122447|FG002|Participant Flow|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
10829650|NCT00122447|FG003|Participant Flow|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
10829651|NCT00122447|OG000|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
10829652|NCT00122447|OG001|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
10829653|NCT00122447|OG002|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
10829654|NCT00122447|OG003|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
11336109|NCT03560986|EG000|Reported Event|Baseline to Week 26: Placebo TPA|In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.
10829655|NCT00122447|OG000|Outcome|Normal Glucose Tolerance (NGT)|Normal fasting glucose (<100 mg/dl) and normal 2-hr glucose level (<140 mg/dl) after 75g OGTT
10829656|NCT00122447|OG001|Outcome|Impaired Glucose Tolerance (IGT)|"After 75g OGTT:~Fasting glucose <126 mg/dl and 2-hr glucose level 140-199 mg/dl"
10829657|NCT00122447|OG002|Outcome|Diabetes|"After 75g OGTT:~Fasting glucose >=126 mg/dl and 2-hr glucose level >=200 mg/dl"
10829658|NCT00122447|EG000|Reported Event|Aspirin|Anti-inflammatory agent
10829659|NCT00122447|EG001|Reported Event|Olmesartan|Angiotensin receptor blocker (ARB)
10829660|NCT00122447|EG002|Reported Event|Alpha Lipoic Acid|Antioxidant
10829661|NCT00122447|EG003|Reported Event|Placebo|Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
10829662|NCT00122447|EG004|Reported Event|Enrolled, But Not Yet Randomized|Enrolled into study, but not yet randomized to study medication
10829663|NCT00122460|BG000|Baseline|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829664|NCT00122460|BG001|Baseline|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829665|NCT00122460|BG002|Baseline|Total|Total of all reporting groups
10829666|NCT00122460|FG000|Participant Flow|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829667|NCT00122460|FG001|Participant Flow|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829668|NCT00122460|OG000|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829669|NCT00122460|OG001|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829670|NCT00122460|EG000|Reported Event|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829671|NCT00122460|EG001|Reported Event|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
10829672|NCT00122681|BG000|Baseline|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
10829673|NCT00122681|BG001|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
10829674|NCT00122681|BG002|Baseline|Total|Total of all reporting groups
10829675|NCT00122681|FG000|Participant Flow|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
10829676|NCT00122681|FG001|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
10829677|NCT00122681|OG000|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
10829678|NCT00122681|OG001|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
10829679|NCT00122681|OG000|Outcome|Cervarix Group Without HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
10829680|NCT00122681|OG001|Outcome|Cervarix Group With HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
10829681|NCT00122681|OG000|Outcome|Cervarix Group Without HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
10829682|NCT00122681|OG001|Outcome|Cervarix Group With HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
10829683|NCT00122681|OG000|Outcome|Cervarix Group Without HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
10829684|NCT00122681|OG001|Outcome|Cervarix Group With HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
10829685|NCT00122681|OG000|Outcome|Cervarix Group Without HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
10829686|NCT00122681|OG001|Outcome|Cervarix Group With HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
10829687|NCT00122681|EG000|Reported Event|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
10829688|NCT00122681|EG001|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
10829689|NCT00122954|BG000|Baseline|Placebo|Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.
10829690|NCT00122954|BG001|Baseline|Fish Oil Concentrate|Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)
10829691|NCT00122954|BG002|Baseline|Total|Total of all reporting groups
10829692|NCT00122954|FG000|Participant Flow|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
10829693|NCT00122954|FG001|Participant Flow|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
10829694|NCT00122954|OG000|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
10829695|NCT00122954|OG001|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
10829696|NCT00122954|EG000|Reported Event|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
10829697|NCT00122954|EG001|Reported Event|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
10829698|NCT00122980|BG000|Baseline|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
10829699|NCT00122980|BG001|Baseline|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
10829700|NCT00122980|BG002|Baseline|Total|Total of all reporting groups
10829701|NCT00122980|FG000|Participant Flow|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
10829702|NCT00122980|FG001|Participant Flow|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
10829703|NCT00122980|OG000|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
10829704|NCT00122980|OG001|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
10829705|NCT00122980|EG000|Reported Event|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
10829706|NCT00122980|EG001|Reported Event|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
10829707|NCT00123110|BG000|Baseline|Metformin|metformin plus leuprolide placebo (LP) injection
10829708|NCT00123110|BG001|Baseline|Leuprolide|leuprolide plus metformin placebo (MP) pill
10829709|NCT00123110|BG002|Baseline|Placebo|MP placebo pill plus LP placebo injection
10829710|NCT00123110|BG003|Baseline|Total|Total of all reporting groups
10829711|NCT00123110|FG000|Participant Flow|Metformin|metformin plus leuprolide placebo (LP) injection
10829712|NCT00123110|FG001|Participant Flow|Leuprolide|leuprolide plus metformin placebo (MP) pill
10829713|NCT00123110|FG002|Participant Flow|Placebo|MP placebo pill plus LP placebo injection
10829714|NCT00123110|OG000|Outcome|Metformin|Randomized to metformin plus leuprolide placebo, treating insulin resistance
10829715|NCT00123110|OG001|Outcome|Leuprolide|Randomized to leuprolide plus metformin placebo, pharmacologic lowering of testosterone
10829716|NCT00123110|OG002|Outcome|Placebo|Placebo metformin plus placebo leuprolide
10829717|NCT00123110|EG000|Reported Event|Metformin|metformin plus leuprolide placebo (LP) injection
10829718|NCT00123110|EG001|Reported Event|Leuprolide|leuprolide plus metformin placebo (MP) pill
10829719|NCT00123110|EG002|Reported Event|Placebo|MP placebo pill plus LP placebo injection
10829720|NCT00123123|BG000|Baseline|Placebo|Vehicle control twice a day (oral rinse)
10829721|NCT00123123|BG001|Baseline|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
10829722|NCT00123123|BG002|Baseline|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
10829723|NCT00123123|BG003|Baseline|Total|Total of all reporting groups
10829724|NCT00123123|FG000|Participant Flow|Placebo|Vehicle control twice a day (oral rinse)
10829725|NCT00123123|FG001|Participant Flow|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
10829726|NCT00123123|FG002|Participant Flow|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
10829727|NCT00123123|OG000|Outcome|Placebo|Vehicle control twice a day (oral rinse)
10829728|NCT00123123|OG001|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
10829729|NCT00123123|OG002|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
10829730|NCT00123123|EG000|Reported Event|Placebo|Vehicle control twice a day (oral rinse)
10829731|NCT00123123|EG001|Reported Event|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
10829732|NCT00123123|EG002|Reported Event|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
10829733|NCT00123162|BG000|Baseline|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
10829734|NCT00123162|BG001|Baseline|Placebo|A single vaginal dose of placebo.
10829735|NCT00123162|BG002|Baseline|Total|Total of all reporting groups
10829736|NCT00123162|FG000|Participant Flow|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
10829737|NCT00123162|FG001|Participant Flow|Placebo|A single vaginal dose of placebo.
10829738|NCT00123162|OG000|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
10829739|NCT00123162|OG001|Outcome|Placebo|A single vaginal dose of placebo.
10829740|NCT00123162|EG000|Reported Event|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
10829741|NCT00123162|EG001|Reported Event|Placebo|A single vaginal dose of placebo.
10829742|NCT00123409|BG000|Baseline|Telephone Disease Management|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
10829743|NCT00123409|BG001|Baseline|Usual Care|"Usual Care~Usual Care: Usual care"
10829744|NCT00123409|BG002|Baseline|Total|Total of all reporting groups
10829745|NCT00123409|FG000|Participant Flow|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
10829746|NCT00123409|FG001|Participant Flow|Arm 2|"Usual Care~Usual Care: Usual care"
10829747|NCT00123409|OG000|Outcome|Telephone Based Management|"Telephone Based Management used to reduce alcohol misuse~Telephone disease management: Telephone based care management"
10829748|NCT00123409|OG001|Outcome|Usual Care|"Usual Care~Usual Care: Usual care"
10829749|NCT00123409|OG000|Outcome|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
10829750|NCT00123409|OG001|Outcome|Arm 2|"Usual Care~Usual Care: Usual care"
10829751|NCT00123409|EG000|Reported Event|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
10829752|NCT00123409|EG001|Reported Event|Arm 2|"Usual Care~Usual Care: Usual care"
10829753|NCT00123422|BG000|Baseline|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
10829754|NCT00123422|BG001|Baseline|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
10829755|NCT00123422|BG002|Baseline|Exercise|"Exercise training~Exercise: exercise training"
10829756|NCT00123422|BG003|Baseline|Total|Total of all reporting groups
10829757|NCT00123422|FG000|Participant Flow|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
10829758|NCT00123422|FG001|Participant Flow|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
10829759|NCT00123422|FG002|Participant Flow|Exercise|"Exercise training~Exercise: exercise training"
10829760|NCT00123422|OG000|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
10829761|NCT00123422|OG001|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
10829762|NCT00123422|OG002|Outcome|Exercise|"Exercise training~Exercise: exercise training"
10829763|NCT00123422|EG000|Reported Event|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
10829764|NCT00123422|EG001|Reported Event|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
10829765|NCT00123422|EG002|Reported Event|Exercise|"Exercise training~Exercise: exercise training"
10829766|NCT00123474|BG000|Baseline|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829767|NCT00123474|BG001|Baseline|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10843054|NCT00251719|BG002|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843055|NCT00251719|BG003|Baseline|Total|Total of all reporting groups
10829768|NCT00123474|BG002|Baseline|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829769|NCT00123474|BG003|Baseline|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829770|NCT00123474|BG004|Baseline|Total|Total of all reporting groups
10829771|NCT00123474|FG000|Participant Flow|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829772|NCT00123474|FG001|Participant Flow|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829773|NCT00123474|FG002|Participant Flow|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829774|NCT00123474|FG003|Participant Flow|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829775|NCT00123474|OG000|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829776|NCT00123474|OG001|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829777|NCT00123474|OG000|Outcome|Dasatinib QD|Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829778|NCT00123474|OG001|Outcome|Dasatinib BID|Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829779|NCT00123474|OG002|Outcome|Dasatinib 100 mg Total Daily Dose|Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829780|NCT00123474|OG003|Outcome|Dasatinib 140 mg Total Daily Dose|Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829781|NCT00123474|OG000|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
10829782|NCT00123474|OG001|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829783|NCT00123474|OG002|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829784|NCT00123474|OG003|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829785|NCT00123474|OG000|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
10829786|NCT00123474|OG002|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
10829787|NCT00123474|OG000|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829788|NCT00123474|OG001|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829789|NCT00123474|OG000|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829790|NCT00123474|OG001|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829791|NCT00123474|OG002|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829792|NCT00123474|OG003|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829793|NCT00123474|OG000|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
10829794|NCT00123474|OG001|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829795|NCT00123474|OG002|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829796|NCT00123474|OG003|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829797|NCT00123474|OG000|Outcome|100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829798|NCT00123474|OG001|Outcome|Other Treatment Groups|Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829799|NCT00123474|OG002|Outcome|Total|Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
10829800|NCT00123474|EG000|Reported Event|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
10829801|NCT00123474|EG001|Reported Event|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829802|NCT00123474|EG002|Reported Event|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829803|NCT00123474|EG003|Reported Event|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
10829804|NCT00123487|BG000|Baseline|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829805|NCT00123487|BG001|Baseline|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829806|NCT00123487|BG002|Baseline|Total|Total of all reporting groups
10829807|NCT00123487|FG000|Participant Flow|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829808|NCT00123487|FG001|Participant Flow|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829809|NCT00123487|OG000|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829810|NCT00123487|OG001|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
10829811|NCT00123487|OG001|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829812|NCT00123487|EG000|Reported Event|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829813|NCT00123487|EG001|Reported Event|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
10829814|NCT00123604|BG000|Baseline|Metoprolol|Metoprolol, orally, 200mg, twice daily for five months
10829815|NCT00123604|BG001|Baseline|Carvedilol|Carvedilol, orally, 25mg, twice daily for five months
10829816|NCT00123604|BG002|Baseline|Total|Total of all reporting groups
10829817|NCT00123604|FG000|Participant Flow|Metoprolol|Metoprolol, orally, 200 mg, once daily
10829818|NCT00123604|FG001|Participant Flow|Carvedilol|Carvedilol, orally, 25 mg, once daily
10829819|NCT00123604|OG000|Outcome|Carvedilol|Carvedilol, orally, 25mg, once daily
10829820|NCT00123604|OG001|Outcome|Metoprolol|Metoprolol, orally, 200mg, once daily
10829821|NCT00123604|EG000|Reported Event|Metoprolol|Metoprolol, orally, 200mg, once daily
10829822|NCT00123604|EG001|Reported Event|Carvedilol|Carvedilol, orally, 25 mg, once daily
10829823|NCT00123630|BG000|Baseline|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829824|NCT00123630|BG001|Baseline|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829825|NCT00123630|BG002|Baseline|Total|Total of all reporting groups
10829826|NCT00123630|FG000|Participant Flow|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829827|NCT00123630|FG001|Participant Flow|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829828|NCT00123630|OG000|Outcome|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829829|NCT00123630|OG001|Outcome|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829830|NCT00123630|EG000|Reported Event|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829831|NCT00123630|EG001|Reported Event|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
10829832|NCT00123643|BG000|Baseline|Rosiglitazone|
10829833|NCT00123643|BG001|Baseline|Glyburide|
10829834|NCT00123643|BG002|Baseline|Total|Total of all reporting groups
10829835|NCT00123643|FG000|Participant Flow|Rosiglitazone|
10829836|NCT00123643|FG001|Participant Flow|Glyburide|
10829837|NCT00123643|OG000|Outcome|Rosiglitazone|
10829838|NCT00123643|OG001|Outcome|Glyburide|
10829839|NCT00123643|EG000|Reported Event|Rosiglitazone|
10829840|NCT00123643|EG001|Reported Event|Glyburide|
10829841|NCT00123682|BG000|Baseline|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
10829842|NCT00123682|BG001|Baseline|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
10829843|NCT00123682|BG002|Baseline|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
10829844|NCT00123682|BG003|Baseline|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
10829845|NCT00123682|BG004|Baseline|Total|Total of all reporting groups
10829846|NCT00123682|FG000|Participant Flow|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
10829847|NCT00123682|FG001|Participant Flow|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
10829848|NCT00123682|FG002|Participant Flow|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
10829849|NCT00123682|FG003|Participant Flow|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
10829850|NCT00123682|OG000|Outcome|Proactive Referral and Intensive Telephone Counseling|
10829851|NCT00123682|OG001|Outcome|Reactive Referral and Intensive Counseling|
10829852|NCT00123682|OG002|Outcome|Proactive Referral and Self-help Materials|
10829853|NCT00123682|OG003|Outcome|Reactive Referral and Self-help Materials|
10829854|NCT00123682|OG000|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
10829855|NCT00123682|OG001|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
10829856|NCT00123682|OG002|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
10829857|NCT00123682|OG003|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
10829858|NCT00123682|EG000|Reported Event|Proactive Referral and Intensive Telephone Counseling|
10829859|NCT00123682|EG001|Reported Event|Reactive Referral and Intensive Counseling|
10829860|NCT00123682|EG002|Reported Event|Proactive Referral and Self-help Materials|
10829861|NCT00123682|EG003|Reported Event|Reactive Referral and Self-help Materials|
10829862|NCT00123734|BG000|Baseline|Group 1|
10829863|NCT00123734|FG000|Participant Flow|Group 1|
10829864|NCT00123734|OG000|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
10829865|NCT00123734|OG001|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
10829866|NCT00123734|OG002|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
10829867|NCT00123734|OG003|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
10829868|NCT00123734|EG000|Reported Event|Group 1|
10829869|NCT00123955|BG000|Baseline|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
10829870|NCT00123955|BG001|Baseline|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
10829871|NCT00123955|BG002|Baseline|Total|Total of all reporting groups
10829872|NCT00123955|FG000|Participant Flow|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
10829873|NCT00123955|FG001|Participant Flow|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
10829874|NCT00123955|OG000|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
10829875|NCT00123955|OG001|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
10829876|NCT00123955|EG000|Reported Event|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
10829877|NCT00123955|EG001|Reported Event|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
10829878|NCT00124020|BG000|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
10829879|NCT00124020|BG001|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
10829880|NCT00124020|BG002|Baseline|Total|Total of all reporting groups
10829881|NCT00124020|FG000|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
10829882|NCT00124020|FG001|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
10829883|NCT00124020|OG000|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
10829884|NCT00124020|OG001|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
10829885|NCT00124020|EG000|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
10829886|NCT00124020|EG001|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
10829887|NCT00124072|BG000|Baseline|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
10829888|NCT00124072|BG001|Baseline|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
10829889|NCT00124072|BG002|Baseline|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
10829890|NCT00124072|BG003|Baseline|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
10829891|NCT00124072|BG004|Baseline|Total|Total of all reporting groups
10829892|NCT00124072|FG000|Participant Flow|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
10829893|NCT00124072|FG001|Participant Flow|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
10829894|NCT00124072|FG002|Participant Flow|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
10829895|NCT00124072|FG003|Participant Flow|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
10829896|NCT00124072|OG000|Outcome|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
10829897|NCT00124072|OG001|Outcome|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
10829898|NCT00124072|OG002|Outcome|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
10829899|NCT00124072|OG003|Outcome|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
10829900|NCT00124072|EG000|Reported Event|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
10829901|NCT00124072|EG001|Reported Event|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
10829902|NCT00124072|EG002|Reported Event|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
10829903|NCT00124072|EG003|Reported Event|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
10829904|NCT00124176|BG000|Baseline|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
10829905|NCT00124176|BG001|Baseline|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
10829906|NCT00124176|BG002|Baseline|Total|Total of all reporting groups
10829907|NCT00124176|FG000|Participant Flow|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
10829908|NCT00124176|FG001|Participant Flow|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
10829909|NCT00124176|OG000|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
10829910|NCT00124176|OG001|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
10829911|NCT00124176|EG000|Reported Event|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
10829912|NCT00124176|EG001|Reported Event|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
10829913|NCT00124449|BG000|Baseline|Abatacept|Abatacept by IV infusion, dose based on participant's body weight at the screening visit
10829914|NCT00124449|BG001|Baseline|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
10829915|NCT00124449|BG002|Baseline|Total|Total of all reporting groups
10829916|NCT00124449|FG000|Participant Flow|Abatacept|Abatacept by intravenous (IV) infusion, dose based on participant's body weight at the screening visit
10829917|NCT00124449|FG001|Participant Flow|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
10829918|NCT00124449|OG000|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject's body weight at the screening visit
10829919|NCT00124449|OG001|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
10829920|NCT00124449|OG000|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant's body weight at the screening visit
10829921|NCT00124449|EG000|Reported Event|BMS-188667|
10829922|NCT00124449|EG001|Reported Event|Placebo|
10829923|NCT00124462|BG000|Baseline|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
10829924|NCT00124462|BG001|Baseline|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
10829925|NCT00124462|BG002|Baseline|Total|Total of all reporting groups
10829926|NCT00124462|FG000|Participant Flow|Realignment to Placebo|"Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear.~Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole"
10829927|NCT00124462|FG001|Participant Flow|Placebo to Realignment|"Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear."
10829928|NCT00124462|OG000|Outcome|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
10829929|NCT00124462|OG001|Outcome|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
10829930|NCT00124462|EG000|Reported Event|Realignment to Placebo|"Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
10829931|NCT00124462|EG001|Reported Event|Placebo to Realignment|Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
10829932|NCT00124514|BG000|Baseline|Placebo|"Normal Saline~placebo: placebo 0.9% normal saline IM injection"
10829933|NCT00124514|BG001|Baseline|Triptorelin T1|Triptorelin Pamoate 25 μg/kg body weight
10829934|NCT00124514|BG002|Baseline|Triptorelin T2|Triptorelin Pamoate 50 μg/kg body weight
10829935|NCT00124514|BG003|Baseline|Triptorelin T3|Triptorelin Pamoate 75 μg/kg body weight
10829936|NCT00124514|BG004|Baseline|Triptorelin T4|Triptorelin Pamoate 100 μg/kg body weight
10829937|NCT00124514|BG005|Baseline|Total|Total of all reporting groups
10829938|NCT00124514|FG000|Participant Flow|Placebo|Normal Saline
10829939|NCT00124514|FG001|Participant Flow|Triptorelin T1|"Triptorelin Pamoate 25 μg/kg body weight starting dose~Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained."
10829940|NCT00124514|FG002|Participant Flow|Triptorelin T2|"Triptorelin Pamoate 50 μg/kg body weight starting dose~Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained."
10829941|NCT00124514|FG003|Participant Flow|Triptorelin T3|"Triptorelin Pamoate 75 μg/kg body weight starting dose~Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained."
10829942|NCT00124514|FG004|Participant Flow|Triptorelin T4|"Triptorelin Pamoate 100 μg/kg body weight starting dose~Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained."
10829943|NCT00124514|OG000|Outcome|Placebo|"Normal Saline~placebo: placebo 0.9% normal saline IM injection"
10829944|NCT00124514|OG001|Outcome|Triptorelin (T1-T4)|Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
10829945|NCT00124514|OG001|Outcome|Triptorelin|"Triptorelin Pamoate~Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis."
10829946|NCT00124514|EG000|Reported Event|Placebo Group|"Normal Saline~placebo: placebo 0.9% normal saline IM injection"
10829947|NCT00124514|EG001|Reported Event|Triptorelin|"Triptorelin Pamoate~Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis."
10829948|NCT00124579|BG000|Baseline|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
10829949|NCT00124579|FG000|Participant Flow|Bortezomib With Thalidomide and Dexamethasone Induction|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
10829950|NCT00124579|OG000|Outcome|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
10829951|NCT00124579|OG000|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
10829952|NCT00124579|EG000|Reported Event|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
10829953|NCT00124618|BG000|Baseline|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
10829954|NCT00124618|FG000|Participant Flow|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
10829955|NCT00124618|OG000|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
10829956|NCT00124618|EG000|Reported Event|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
10829957|NCT00124657|BG000|Baseline|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
10829958|NCT00124657|BG001|Baseline|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
10829959|NCT00124657|BG002|Baseline|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
10829960|NCT00124657|BG003|Baseline|Total|Total of all reporting groups
10829961|NCT00124657|FG000|Participant Flow|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
10829962|NCT00124657|FG001|Participant Flow|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
10829963|NCT00124657|FG002|Participant Flow|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
10829964|NCT00124657|OG000|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
10829965|NCT00124657|OG001|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
10829966|NCT00124657|OG002|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
10829967|NCT00124657|OG003|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
10829968|NCT00124657|OG000|Outcome|Phase I|Phase I participants
10829969|NCT00124657|OG000|Outcome|Phase I|22 participants were analyzed for MLT over 4 dose levels.
10829970|NCT00124657|OG000|Outcome|Phase I AA|All participants with a diagnosis of anaplastic astrocytoma (AA) and treated on Phase I.
10829971|NCT00124657|OG001|Outcome|Phase I GBM|All participants with a diagnosis of glioblastoma multiforme (GBM) and treated on Phase I.
10829972|NCT00124657|OG002|Outcome|Phase II AA|Participants with a diagnosis of intracranial anaplastic astrocytoma (AA) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
10829973|NCT00124657|OG003|Outcome|Phase II GBM|Participants with a diagnosis of intracranial glioblastoma multiforme (GBM) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
10829974|NCT00124657|OG000|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
10829975|NCT00124657|OG000|Outcome|Patients With High-Grade/Low-Grade Glioma|"Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.~Erlotinib hydrochloride: This study had 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib was given at the MTD during and after RT for 2 years."
10829976|NCT00124657|OG000|Outcome|Grade 3 Toxicity|Grade 3 toxicity per CTCAE 3.0.
10829977|NCT00124657|OG001|Outcome|Grade 4 Toxicity|Grade 4 toxicity per CTCAE 3.0.
10829978|NCT00124657|EG000|Reported Event|70 mg/m^2 (Phase I)|Participants received dose of 70 mg/m^2, range of actual dose was 68-83 mg/m^2.
10829979|NCT00124657|EG001|Reported Event|90 mg/m^2 (Phase I)|Participants received dose of 90 mg/m^2, range of actual dose was 85-87.5 mg/m^2.
10829980|NCT00124657|EG002|Reported Event|120 mg/m^2 (Phase I)|Participants received dose of 120 mg/m^2, range of actual dose was 107-128 mg/m^2.
10829981|NCT00124657|EG003|Reported Event|160 mg/m^2 (Phase I)|Participants received dose of 160 mg/m^2, range of actual dose was 151.5-167 mg/m^2.
10829982|NCT00124657|EG004|Reported Event|Phase II|Phase II participants received 120 mg/m^2.
10829983|NCT00124709|BG000|Baseline|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
10829984|NCT00124709|BG001|Baseline|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
10829985|NCT00124709|BG002|Baseline|Total|Total of all reporting groups
10829986|NCT00124709|FG000|Participant Flow|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
10829987|NCT00124709|FG001|Participant Flow|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
10829988|NCT00124709|OG000|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
10829989|NCT00124709|OG001|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
10829990|NCT00124709|EG000|Reported Event|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
10829991|NCT00124709|EG001|Reported Event|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
10829992|NCT00124735|BG000|Baseline|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10829993|NCT00124735|BG001|Baseline|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10829994|NCT00124735|BG002|Baseline|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10829995|NCT00124735|BG003|Baseline|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10829996|NCT00124735|BG004|Baseline|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10829997|NCT00124735|BG005|Baseline|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10829998|NCT00124735|BG006|Baseline|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10829999|NCT00124735|BG007|Baseline|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830000|NCT00124735|BG008|Baseline|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830001|NCT00124735|BG009|Baseline|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830002|NCT00124735|BG010|Baseline|Total|Total of all reporting groups
10830003|NCT00124735|FG000|Participant Flow|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830004|NCT00124735|FG001|Participant Flow|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830005|NCT00124735|FG002|Participant Flow|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830006|NCT00124735|FG003|Participant Flow|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830007|NCT00124735|FG004|Participant Flow|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830008|NCT00124735|FG005|Participant Flow|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830009|NCT00124735|FG006|Participant Flow|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830010|NCT00124735|FG007|Participant Flow|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830011|NCT00124735|FG008|Participant Flow|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830012|NCT00124735|FG009|Participant Flow|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830013|NCT00124735|OG000|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830014|NCT00124735|OG001|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830015|NCT00124735|OG002|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830016|NCT00124735|OG003|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830017|NCT00124735|OG004|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
10830018|NCT00124735|OG005|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830019|NCT00124735|OG006|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830020|NCT00124735|OG007|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830021|NCT00124735|OG008|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830022|NCT00124735|OG009|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
10830023|NCT00124735|EG000|Reported Event|Rocuronium Bolus Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
10830024|NCT00124735|EG001|Reported Event|Rocuronium Continuous Infusion Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
10830025|NCT00124748|BG000|Baseline|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
10830026|NCT00124748|BG001|Baseline|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
10830027|NCT00124748|BG002|Baseline|Total|Total of all reporting groups
10830028|NCT00124748|FG000|Participant Flow|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
10830029|NCT00124748|FG001|Participant Flow|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
10830030|NCT00124748|OG000|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
10830031|NCT00124748|OG001|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
10830032|NCT00124748|EG000|Reported Event|Imatinib 400mg|Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
10830033|NCT00124748|EG001|Reported Event|Imatinib 800mg|Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
10830034|NCT00124917|BG000|Baseline|Radiation Therapy - 7560 cGY|"Radiation to tumor area as per protocol~Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]"
10830035|NCT00124917|FG000|Participant Flow|Radiation Therapy - 7560 cGY|"Radiation to tumor area as per protocol~Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]"
10830036|NCT00124917|OG000|Outcome|Radiation Therapy - 7560 cGY|"Radiation to tumor area as per protocol~Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]"
10830037|NCT00124917|OG000|Outcome|Radiation Therapy - 7560 cGY|"Radiation to tumor area as per protocol~Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 centigray (cGy) daily fractions.[1]"
10830038|NCT00124917|EG000|Reported Event|Radiation Therapy - 7560 cGY|"Radiation to tumor area as per protocol~Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]"
10830039|NCT00124943|BG000|Baseline|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
10830040|NCT00124943|BG001|Baseline|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830041|NCT00124943|BG002|Baseline|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830042|NCT00124943|BG003|Baseline|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830043|NCT00124943|BG004|Baseline|Total|Total of all reporting groups
10830044|NCT00124943|FG000|Participant Flow|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
10830045|NCT00124943|FG001|Participant Flow|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830046|NCT00124943|FG002|Participant Flow|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830047|NCT00124943|FG003|Participant Flow|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830048|NCT00124943|OG000|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
10830049|NCT00124943|OG001|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830050|NCT00124943|OG002|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830051|NCT00124943|OG003|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830052|NCT00124943|EG000|Reported Event|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
10830053|NCT00124943|EG001|Reported Event|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830054|NCT00124943|EG002|Reported Event|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830055|NCT00124943|EG003|Reported Event|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
10830056|NCT00124982|BG000|Baseline|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830057|NCT00124982|BG001|Baseline|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830058|NCT00124982|BG002|Baseline|Total|Total of all reporting groups
10830059|NCT00124982|FG000|Participant Flow|Short Term (ST) Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830060|NCT00124982|FG001|Participant Flow|ST-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830061|NCT00124982|FG002|Participant Flow|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
10830062|NCT00124982|OG000|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830063|NCT00124982|OG001|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830064|NCT00124982|OG000|Outcome|All Treated Participants|Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830065|NCT00124982|OG000|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
10830066|NCT00124982|OG000|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
10830067|NCT00124982|EG000|Reported Event|Abatacept (LT)|
10830068|NCT00124982|EG001|Reported Event|Abatacept (ST)|
10830069|NCT00125034|BG000|Baseline|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830070|NCT00125034|BG001|Baseline|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830071|NCT00125034|BG002|Baseline|Total|Total of all reporting groups
10830072|NCT00125034|FG000|Participant Flow|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830073|NCT00125034|FG001|Participant Flow|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830074|NCT00125034|OG000|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830075|NCT00125034|OG001|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830076|NCT00125034|EG000|Reported Event|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830077|NCT00125034|EG001|Reported Event|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
10830078|NCT00125138|BG000|Baseline|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
10830079|NCT00125138|BG001|Baseline|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
10830080|NCT00125138|BG002|Baseline|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
10830081|NCT00125138|BG003|Baseline|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
10830082|NCT00125138|BG004|Baseline|Total|Total of all reporting groups
10830083|NCT00125138|FG000|Participant Flow|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
10830084|NCT00125138|FG001|Participant Flow|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
10830085|NCT00125138|FG002|Participant Flow|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
10830086|NCT00125138|FG003|Participant Flow|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
10830087|NCT00125138|OG000|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
10830088|NCT00125138|OG001|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
10830089|NCT00125138|OG002|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
10830090|NCT00125138|OG003|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
10830091|NCT00125138|EG000|Reported Event|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
10830092|NCT00125138|EG001|Reported Event|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
10830093|NCT00125138|EG002|Reported Event|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
10830094|NCT00125138|EG003|Reported Event|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
10830095|NCT00125164|BG000|Baseline|Untreated|Observational Group
10830096|NCT00125164|BG001|Baseline|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
10830097|NCT00125164|BG002|Baseline|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
10830098|NCT00125164|BG003|Baseline|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
10830099|NCT00125164|BG004|Baseline|Total|Total of all reporting groups
10830100|NCT00125164|FG000|Participant Flow|Untreated|Observational Group
10830101|NCT00125164|FG001|Participant Flow|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
10830102|NCT00125164|FG002|Participant Flow|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
10830103|NCT00125164|FG003|Participant Flow|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
10830104|NCT00125164|OG000|Outcome|Untreated|Observational Group
10830105|NCT00125164|OG001|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
10830106|NCT00125164|OG002|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
10830107|NCT00125164|OG003|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
11336110|NCT03560986|EG001|Reported Event|Baseline to Week 26: Neridronic Acid TPA|In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
10830108|NCT00125164|EG000|Reported Event|Untreated|Observational Group
10830109|NCT00125164|EG001|Reported Event|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
10830110|NCT00125164|EG002|Reported Event|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
10830111|NCT00125164|EG003|Reported Event|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
10830112|NCT00125190|BG000|Baseline|rhIGF-1 QD|During the treatment phase (Day 1 to Week 86), subjects received SC injections of rhIGF-1 at an initial dose of 60 mcg/kg QD starting on Day 1 (Visit 3). From Week 2 (Visit 4) subsequent dose adjustments were made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day.
10830113|NCT00125190|FG000|Participant Flow|rhIGF-1 QD|During the treatment phase (Day 1 to Week 86), subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 microgram per kilogram (mcg/kg) once daily (QD) starting on Day 1 (Visit 3). From Week 2 (Visit 4) subsequent dose adjustments were made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day.
10830114|NCT00125190|OG000|Outcome|rhIGF-1 QD|During the treatment phase (Day 1 to Week 86), subjects received SC injections of rhIGF-1 at an initial dose of 60 mcg/kg QD starting on Day 1 (Visit 3). From Week 2 (Visit 4) subsequent dose adjustments were made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day.
10830115|NCT00125190|OG000|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day.
10830116|NCT00125190|EG000|Reported Event|rhIGF-1 QD|During the treatment phase (Day 1 to Week 86), subjects received SC injections of rhIGF-1 at an initial dose of 60 mcg/kg QD starting on Day 1 (Visit 3). From Week 2 (Visit 4) subsequent dose adjustments were made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day.
10830117|NCT00125242|BG000|Baseline|SFA Treatment Participants|Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.
10843056|NCT00251719|FG000|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10843057|NCT00251719|FG001|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843058|NCT00251719|FG002|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
11336111|NCT03560986|EG002|Reported Event|Week 26 to Week 52: Placebo TPA|Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
10830118|NCT00125242|BG001|Baseline|Non Treatment Stimuli Development Participants|Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., & Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.
10830119|NCT00125242|BG002|Baseline|Total|Total of all reporting groups
10830120|NCT00125242|FG000|Participant Flow|Non Treatment Stimuli Development Participants|Non-brain-injured participants who were enrolled for the purpose of stimuli development
10830121|NCT00125242|FG001|Participant Flow|SFA Treatment Participants|Stroke survivors who received experimental therapy
10830122|NCT00125242|OG000|Outcome|SFA Treatment Participants|Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
10830123|NCT00125242|EG000|Reported Event|SFA Treatment Participants|"Stroke-survivors who received Semantic Feature Analysis therapy for aphasic word-retrieval deficits~Semantic Feature Training: The treatment is designed to stimulate the semantic feature network so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures."
10830124|NCT00125242|EG001|Reported Event|NonTreatment Stimuli Development Participants|Non-brain-injured participants who were utilized to develop treatment stimuli.
10830125|NCT00125359|BG000|Baseline|Single Arm Erlotinib + Bexarotene|"All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.~erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg."
10830126|NCT00125359|FG000|Participant Flow|Single Arm Erlotinib + Bexarotene|"All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.~erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg."
10830127|NCT00125359|OG000|Outcome|Single Arm Erlotinib + Bexarotene|"All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.~erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg."
10830128|NCT00125359|EG000|Reported Event|Single Arm Erlotinib + Bexarotene|"All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.~erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg."
10830129|NCT00125372|BG000|Baseline|Erlotinib and Bexarotene|"Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.~erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy"
10830130|NCT00125372|FG000|Participant Flow|Erlotinib and Bexarotene|"Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.~erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy"
10830131|NCT00125372|OG000|Outcome|Erlotinib and Bexarotene|"Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.~erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy"
10830132|NCT00125372|EG000|Reported Event|Erlotinib and Bexarotene|"Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.~erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy"
10830133|NCT00125515|BG000|Baseline|Placebo|Placebo plus oral naltrexone
10830134|NCT00125515|BG001|Baseline|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
10830135|NCT00125515|BG002|Baseline|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
10830136|NCT00125515|BG003|Baseline|Total|Total of all reporting groups
10830137|NCT00125515|FG000|Participant Flow|Placebo|Placebo plus oral naltrexone
10830138|NCT00125515|FG001|Participant Flow|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
10830139|NCT00125515|FG002|Participant Flow|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
10830140|NCT00125515|OG000|Outcome|Placebo|Placebo plus oral naltrexone
10830141|NCT00125515|OG001|Outcome|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
10830142|NCT00125515|OG002|Outcome|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
10830143|NCT00125515|EG000|Reported Event|Placebo|Placebo plus oral naltrexone
10830144|NCT00125515|EG001|Reported Event|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
10830145|NCT00125515|EG002|Reported Event|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
10830146|NCT00125528|BG000|Baseline|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
10830147|NCT00125528|BG001|Baseline|Placebo|placebo: placebo bid
10830148|NCT00125528|BG002|Baseline|Total|Total of all reporting groups
10830149|NCT00125528|FG000|Participant Flow|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
10830150|NCT00125528|FG001|Participant Flow|Placebo|placebo: placebo bid
10830151|NCT00125528|OG000|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
10830152|NCT00125528|OG001|Outcome|Placebo|placebo: placebo bid
10830153|NCT00125528|EG000|Reported Event|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
10830154|NCT00125528|EG001|Reported Event|Placebo|placebo: placebo bid
10830155|NCT00125593|BG000|Baseline|Simvastatin Plus Ezetimibe|Once daily tablet
10830156|NCT00125593|BG001|Baseline|Placebo|Once daily tablet
10830157|NCT00125593|BG002|Baseline|Total|Total of all reporting groups
10830158|NCT00125593|FG000|Participant Flow|Simvastatin 20mg Plus Ezetimibe 10mg|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
10830159|NCT00125593|FG001|Participant Flow|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
10830160|NCT00125593|OG000|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
10830161|NCT00125593|OG001|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
10830162|NCT00125593|EG000|Reported Event|Simvastatin Plus Ezetimibe|Once daily tablet
10830163|NCT00125593|EG001|Reported Event|Placebo|Once daily tablet
10830164|NCT00125619|BG000|Baseline|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
10830165|NCT00125619|BG001|Baseline|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
10830166|NCT00125619|BG002|Baseline|Total|Total of all reporting groups
10830167|NCT00125619|FG000|Participant Flow|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
10830168|NCT00125619|FG001|Participant Flow|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
10830169|NCT00125619|OG000|Outcome|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
10830170|NCT00125619|OG001|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
10830171|NCT00125619|OG000|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
10830172|NCT00125619|EG000|Reported Event|ARM2|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
10830173|NCT00125619|EG001|Reported Event|Arm 1|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
10830174|NCT00125658|BG000|Baseline|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
10830175|NCT00125658|BG001|Baseline|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
10830176|NCT00125658|BG002|Baseline|Total|Total of all reporting groups
10830177|NCT00125658|FG000|Participant Flow|Order A (FTP Prior to Power)|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
10830178|NCT00125658|FG001|Participant Flow|Order B (Power Prior to FTP)|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
10830179|NCT00125658|OG000|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
10830180|NCT00125658|OG001|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
10830181|NCT00125658|OG000|Outcome|Order A|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
10830182|NCT00125658|OG001|Outcome|Order B|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
10830183|NCT00125658|EG000|Reported Event|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
10830184|NCT00125658|EG001|Reported Event|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
10830185|NCT00125762|BG000|Baseline|Single Arm Undergoing FibroScan|"Single arm active comparison of biopsy to vibration controlled elastography~FibroScan"
10830186|NCT00125762|FG000|Participant Flow|Active Arm|All patients received a liver biopsy and a FibroScan
10830187|NCT00125762|OG000|Outcome|Single Arm Undergoing FibroScan|"Single arm active comparison of biopsy to vibration controlled elastography~FibroScan"
10830188|NCT00125762|EG000|Reported Event|Active Arm|All patients received a liver biopsy and a FibroScan
10843059|NCT00251719|OG000|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10830189|NCT00125788|BG000|Baseline|Investigational Product|"L-glutamine~L-glutamine: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830190|NCT00125788|BG001|Baseline|Placebo|"maltodextrin~Placebo: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830191|NCT00125788|BG002|Baseline|Total|Total of all reporting groups
10830192|NCT00125788|FG000|Participant Flow|Investigational Product|"L-glutamine~L-glutamine: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830193|NCT00125788|FG001|Participant Flow|Placebo|"maltodextrin~Placebo: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830194|NCT00125788|OG000|Outcome|Investigational Product|"L-glutamine~L-glutamine: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830195|NCT00125788|OG001|Outcome|Placebo|"maltodextrin~Placebo: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830196|NCT00125788|EG000|Reported Event|Investigational Product|"L-glutamine~L-glutamine: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830197|NCT00125788|EG001|Reported Event|Placebo|"maltodextrin~Placebo: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams."
10830198|NCT00125853|BG000|Baseline|All Participants|Crossover study design all participants will receive both treatments
10830199|NCT00125853|FG000|Participant Flow|First is Atenolol Followed by Nebivolol (AN)|Atenolol 25mg daily for 8 weeks, followed by a 4-week wash-out period, then nebivolol 2.5 mg daily for 8 weeks
10830200|NCT00125853|FG001|Participant Flow|First is Nebivolol Followed by Atenolol (NA)|Nebivolol 2.5mg daily for 8 weeks, followed by a 4-week wash-out period, then atenolol 25 mg daily for 8 weeks
10830201|NCT00125853|OG000|Outcome|Atenolol|Participants received Atenolol 25mg daily for 8 weeks
10830202|NCT00125853|OG001|Outcome|Nebivolol|Participants received Nebivolol 2.5mg daily for 8 weeks
10830203|NCT00125853|EG000|Reported Event|Atenolol 25mg Daily|"atenolol 25mg daily~Atenolol: Atenolol 25mg daily"
10830204|NCT00125853|EG001|Reported Event|Nebivolol 2.5mg Daily|"nebivolol 2.5mg daily~Nebivolol: Nebivolol 25mg daily"
10830205|NCT00125931|BG000|Baseline|Open Label|Open label treatment with pentazocine
10830206|NCT00125931|FG000|Participant Flow|Treatment Group|Open label group with pentazocine treatment.
10830207|NCT00125931|OG000|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
10830208|NCT00125931|EG000|Reported Event|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
10830209|NCT00125957|BG000|Baseline|Wellbutrin-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
10830210|NCT00125957|BG001|Baseline|Placebo-Wellbutrin|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
10830211|NCT00125957|BG002|Baseline|Total|Total of all reporting groups
10830212|NCT00125957|FG000|Participant Flow|Wellbutrin First, Then Placebo|Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
10830213|NCT00125957|FG001|Participant Flow|Placebo First, Then Wellbutrin|Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
10830214|NCT00125957|OG000|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
10830215|NCT00125957|OG001|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
10830216|NCT00125957|EG000|Reported Event|Bupropion-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
10830217|NCT00125957|EG001|Reported Event|Placebo-Bupropion|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to bupropion 100 mg BID. At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
10830218|NCT00126113|BG000|Baseline|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
10830219|NCT00126113|BG001|Baseline|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
10830220|NCT00126113|BG002|Baseline|Total|Total of all reporting groups
10830221|NCT00126113|FG000|Participant Flow|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
10830222|NCT00126113|FG001|Participant Flow|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
10830223|NCT00126113|OG000|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
10830224|NCT00126113|OG001|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
10830225|NCT00126113|EG000|Reported Event|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
10830226|NCT00126113|EG001|Reported Event|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
10830227|NCT00126126|BG000|Baseline|Intervention|Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
10830228|NCT00126126|BG001|Baseline|Wait List Control Group|Those subjects who were randomized to the wait-list control group.
10830229|NCT00126126|BG002|Baseline|Total|Total of all reporting groups
10830230|NCT00126126|FG000|Participant Flow|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
10830231|NCT00126126|FG001|Participant Flow|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
10830232|NCT00126126|OG000|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
10830233|NCT00126126|OG001|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
10830234|NCT00126126|EG000|Reported Event|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
10830235|NCT00126126|EG001|Reported Event|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
10830236|NCT00126191|BG000|Baseline|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
10830237|NCT00126191|BG001|Baseline|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
10830238|NCT00126191|BG002|Baseline|Total|Total of all reporting groups
10830239|NCT00126191|FG000|Participant Flow|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
10830240|NCT00126191|FG001|Participant Flow|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
10830241|NCT00126191|OG000|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
10830242|NCT00126191|OG001|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
10830243|NCT00126191|EG000|Reported Event|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
10830244|NCT00126191|EG001|Reported Event|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
10830245|NCT00126425|BG000|Baseline|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.
10830246|NCT00126425|BG001|Baseline|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
10830247|NCT00126425|BG002|Baseline|Total|Total of all reporting groups
10830248|NCT00126425|FG000|Participant Flow|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
10830249|NCT00126425|FG001|Participant Flow|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
11336112|NCT03560986|EG003|Reported Event|Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB|Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.
10830250|NCT00126425|OG000|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6)
10830251|NCT00126425|OG001|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6)
10830252|NCT00126425|EG000|Reported Event|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
10830253|NCT00126425|EG001|Reported Event|AdreView --Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
10830254|NCT00126438|BG000|Baseline|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
10830255|NCT00126438|BG001|Baseline|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
10830256|NCT00126438|BG002|Baseline|Total|Total of all reporting groups
10830257|NCT00126438|FG000|Participant Flow|AdreView - Heart Failure Group|AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose.
10830258|NCT00126438|FG001|Participant Flow|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
10830259|NCT00126438|OG000|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6).
10830260|NCT00126438|OG001|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6).
10830261|NCT00126438|EG000|Reported Event|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
10830262|NCT00126438|EG001|Reported Event|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
10830263|NCT00126490|BG000|Baseline|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
10830264|NCT00126490|FG000|Participant Flow|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
10830265|NCT00126490|OG000|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
10830266|NCT00126490|EG000|Reported Event|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
10830267|NCT00126503|BG000|Baseline|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
10830268|NCT00126503|BG001|Baseline|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
10830269|NCT00126503|BG002|Baseline|Total|Total of all reporting groups
10830270|NCT00126503|FG000|Participant Flow|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
10830271|NCT00126503|FG001|Participant Flow|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
10830272|NCT00126503|OG000|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
10830273|NCT00126503|OG000|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
10830274|NCT00126503|OG001|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
10830275|NCT00126503|OG000|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
10830276|NCT00126503|OG000|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.
10830277|NCT00126503|OG001|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.
10830278|NCT00126503|EG000|Reported Event|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
10830279|NCT00126503|EG001|Reported Event|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
10830280|NCT00126555|BG000|Baseline|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
11336113|NCT03560986|EG004|Reported Event|Week 26 to Week 52: Neridronic Acid TPA|Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
10830281|NCT00126555|FG000|Participant Flow|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
10830282|NCT00126555|OG000|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
10830283|NCT00126555|OG000|Outcome|Patients Completed Induction Gefitinib|All patients treated induction gefitinib within 60 days
10830284|NCT00126555|OG001|Outcome|Patients Received the Escalated Gefitinib Dose|Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.
10830285|NCT00126555|OG002|Outcome|Patients Treated Radiation and Concurrent Gefitinib|Unresectable patients treated concomitant gefitinib with radiotherapy
10830286|NCT00126555|OG000|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
10830287|NCT00126555|OG001|Outcome|Induction With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
10830288|NCT00126555|OG002|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
10830289|NCT00126555|OG003|Outcome|Maintenance|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
10830290|NCT00126555|OG001|Outcome|Induction Phase With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
10830291|NCT00126555|OG003|Outcome|Maintenance Phase|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
10830292|NCT00126555|OG000|Outcome|Recurrence Status|Patients had recurrence within the first year after completion of treatment
10830293|NCT00126555|OG001|Outcome|Survival Status|At the time of last contact
10830294|NCT00126555|OG000|Outcome|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
10830295|NCT00126555|EG000|Reported Event|Gefitinib, Radiotherapy, Surgery|"Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation.~Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
10830296|NCT00126568|BG000|Baseline|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
10830297|NCT00126568|FG000|Participant Flow|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
10830298|NCT00126568|OG000|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
10830299|NCT00126568|OG000|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
10830300|NCT00126568|EG000|Reported Event|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
10830301|NCT00126581|BG000|Baseline|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10830302|NCT00126581|BG001|Baseline|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
10830303|NCT00126581|BG002|Baseline|Total|Total of all reporting groups
10830304|NCT00126581|FG000|Participant Flow|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10830305|NCT00126581|FG001|Participant Flow|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
10830306|NCT00126581|OG000|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10830307|NCT00126581|OG001|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
10830308|NCT00126581|OG000|Outcome|Mutant|
10830309|NCT00126581|OG001|Outcome|Wild Type|
10830310|NCT00126581|EG000|Reported Event|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10830311|NCT00126581|EG001|Reported Event|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
10830312|NCT00126594|BG000|Baseline|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
10830313|NCT00126594|BG001|Baseline|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
10830314|NCT00126594|BG002|Baseline|Total|Total of all reporting groups
10830315|NCT00126594|FG000|Participant Flow|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
10830316|NCT00126594|FG001|Participant Flow|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
10830317|NCT00126594|OG000|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
10830318|NCT00126594|OG001|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
10830319|NCT00126594|OG000|Outcome|Sorafenib Tosylate or Sorafenib Plus Interferon|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
10830320|NCT00126594|EG000|Reported Event|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
10830321|NCT00126594|EG001|Reported Event|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
10830322|NCT00126737|BG000|Baseline|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830323|NCT00126737|BG001|Baseline|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
10830324|NCT00126737|BG002|Baseline|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830325|NCT00126737|BG003|Baseline|Usual Care|Usual care and non-specific health information (C). No intervention.
10830326|NCT00126737|BG004|Baseline|Total|Total of all reporting groups
10830327|NCT00126737|FG000|Participant Flow|Weight Control Nutritional and Home-based Exercise Program|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises"
10830328|NCT00126737|FG001|Participant Flow|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
10830329|NCT00126737|FG002|Participant Flow|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830330|NCT00126737|FG003|Participant Flow|Usual Care|Usual care and non-specific health information (C). No intervention.
10830331|NCT00126737|OG000|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830332|NCT00126737|OG001|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
10830333|NCT00126737|OG002|Outcome|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830334|NCT00126737|OG003|Outcome|Usual Care|Usual care and non-specific health information (C). No intervention.
10830335|NCT00126737|OG002|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830336|NCT00126737|OG003|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
10830337|NCT00126737|OG000|Outcome|Weight Control Nutritional and Home-based Exercise pr|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830338|NCT00126737|EG000|Reported Event|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830339|NCT00126737|EG001|Reported Event|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
10830340|NCT00126737|EG002|Reported Event|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
10830341|NCT00126737|EG003|Reported Event|Usual Care|Usual Care and non-specific health information (C). No intervention.
10830342|NCT00126750|BG000|Baseline|Intervention Arm/Group|Providers from eligible clinics that were allocated to the intervention arm.
10830343|NCT00126750|BG001|Baseline|Control Arm/Group|Providers from eligible clinics that were allocated to the control arm.
10830344|NCT00126750|BG002|Baseline|Total|Total of all reporting groups
10830345|NCT00126750|FG000|Participant Flow|Intervention Group|The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
10830346|NCT00126750|FG001|Participant Flow|Control Group|Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
10830347|NCT00126750|OG000|Outcome|Intervention|Intervention Providers received an interactive, educational website and motivational reminders.
10830348|NCT00126750|OG001|Outcome|Control|Control Providers received a link to VA practice guidelines.
10830349|NCT00126750|EG000|Reported Event|Intervention Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
10830350|NCT00126750|EG001|Reported Event|Control Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
10830351|NCT00127036|BG000|Baseline|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830352|NCT00127036|BG001|Baseline|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830353|NCT00127036|BG002|Baseline|Total|Total of all reporting groups
10830354|NCT00127036|FG000|Participant Flow|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830355|NCT00127036|FG001|Participant Flow|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830356|NCT00127036|OG000|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830357|NCT00127036|OG001|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830358|NCT00127036|EG000|Reported Event|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830359|NCT00127036|EG001|Reported Event|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
10830360|NCT00127062|BG000|Baseline|Mild Asthma|Asthma patients with mild asthma
10830361|NCT00127062|BG001|Baseline|Moderate Asthma|Asthma patients with moderate asthma
10830362|NCT00127062|BG002|Baseline|Total|Total of all reporting groups
10830363|NCT00127062|FG000|Participant Flow|Mild Asthma|Asthma patients with mild asthma
10830364|NCT00127062|FG001|Participant Flow|Moderate Asthma|Asthma patients with moderate asthma
10830365|NCT00127062|OG000|Outcome|Mild Asthma Hyde Park|Mild asthma patients walking on Hyde park
10830366|NCT00127062|OG001|Outcome|Mild Asthma Oxford Street|Mild asthma patients walking on Oxford Street
10830367|NCT00127062|OG002|Outcome|Moderate Asthma Hyde Park|Moderate asthma patients walking on Hyde park
10830368|NCT00127062|OG003|Outcome|Moderate Asthma Oxford Street|Moderate asthma patients walking on Oxford Street
10830369|NCT00127062|EG000|Reported Event|Mild asthma_Oxford Street|Asthma patients with mild asthma walked at Oxford street
10830370|NCT00127062|EG001|Reported Event|Mild asthma_Hyde Park|Asthma patients with mild asthma walked at Hyde park
10830371|NCT00127062|EG002|Reported Event|Moderate asthma_Oxford Street|Asthma patients with moderate asthma walked at Oxford street
10830372|NCT00127062|EG003|Reported Event|Moderate asthma_Hyde Park|Asthma patients with moderate asthma walked at Hyde park
10830373|NCT00127101|BG000|Baseline|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830374|NCT00127101|BG001|Baseline|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830375|NCT00127101|BG002|Baseline|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
10830376|NCT00127101|BG003|Baseline|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
10830377|NCT00127101|BG004|Baseline|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
10830378|NCT00127101|BG005|Baseline|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
10830379|NCT00127101|BG006|Baseline|Total|Total of all reporting groups
10830380|NCT00127101|FG000|Participant Flow|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830381|NCT00127101|FG001|Participant Flow|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830382|NCT00127101|FG002|Participant Flow|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
10830383|NCT00127101|FG003|Participant Flow|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
10830384|NCT00127101|FG004|Participant Flow|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
10830385|NCT00127101|FG005|Participant Flow|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
10830386|NCT00127101|OG000|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830387|NCT00127101|OG001|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830388|NCT00127101|OG002|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
10830389|NCT00127101|OG003|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
10830390|NCT00127101|OG004|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
10830391|NCT00127101|OG005|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
10830392|NCT00127101|EG000|Reported Event|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830393|NCT00127101|EG001|Reported Event|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
10830394|NCT00127101|EG002|Reported Event|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
10830395|NCT00127101|EG003|Reported Event|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
10830396|NCT00127101|EG004|Reported Event|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
11336114|NCT03560986|EG005|Reported Event|Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB|Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
10830397|NCT00127101|EG005|Reported Event|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
10830398|NCT00127166|BG000|Baseline|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
10830399|NCT00127166|BG001|Baseline|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
10830400|NCT00127166|BG002|Baseline|Total|Total of all reporting groups
10830401|NCT00127166|FG000|Participant Flow|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
10830402|NCT00127166|FG001|Participant Flow|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
10830403|NCT00127166|OG000|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
10830404|NCT00127166|OG001|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
10830405|NCT00127166|EG000|Reported Event|Montelukast|"Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.~Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
10843060|NCT00251719|OG001|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843061|NCT00251719|OG002|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10830406|NCT00127166|EG001|Reported Event|Salmeterol|"Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.~Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
10830407|NCT00127192|BG000|Baseline|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
10830408|NCT00127192|BG001|Baseline|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10830409|NCT00127192|BG002|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10830410|NCT00127192|BG003|Baseline|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
10830411|NCT00127192|BG004|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
10830412|NCT00127192|BG005|Baseline|Total|Total of all reporting groups
10830413|NCT00127192|FG000|Participant Flow|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
10830414|NCT00127192|FG001|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10830415|NCT00127192|FG002|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10830416|NCT00127192|FG003|Participant Flow|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
10830417|NCT00127192|FG004|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
10830418|NCT00127192|OG000|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
10830419|NCT00127192|OG001|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10830420|NCT00127192|OG002|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10830421|NCT00127192|OG003|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
10830422|NCT00127192|OG004|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
10830423|NCT00127192|EG000|Reported Event|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
10830424|NCT00127192|EG001|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
10830425|NCT00127192|EG002|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
10830426|NCT00127192|EG003|Reported Event|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
10830427|NCT00127192|EG004|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
10830428|NCT00127205|BG000|Baseline|Arm I Zoledronate|"Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.~zoledronic acid: Given IV"
10830429|NCT00127205|BG001|Baseline|Arm II Clodronate|"Patients receive oral clodronate once daily for 35 months.~clodronate disodium: Given orally"
10830430|NCT00127205|BG002|Baseline|Arm III Ibandronate|"Patients receive oral ibandronate once daily for 35 months.~ibandronate sodium: Given orally"
10830431|NCT00127205|BG003|Baseline|Total|Total of all reporting groups
10830432|NCT00127205|FG000|Participant Flow|Arm I Zoledronate|"Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.~zoledronic acid: Given IV"
10830433|NCT00127205|FG001|Participant Flow|Arm II Clodronate|"Patients receive oral clodronate once daily for 35 months.~clodronate disodium: Given orally"
10830434|NCT00127205|FG002|Participant Flow|Arm III Ibandronate|"Patients receive oral ibandronate once daily for 35 months.~ibandronate sodium: Given orally"
10830435|NCT00127205|OG000|Outcome|Arm I Zoledronate|"Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.~zoledronic acid: Given IV"
10830436|NCT00127205|OG001|Outcome|Arm II Clodronate|"Patients receive oral clodronate once daily for 35 months.~clodronate disodium: Given orally"
10830437|NCT00127205|OG002|Outcome|Arm III Ibandronate|"Patients receive oral ibandronate once daily for 35 months.~ibandronate sodium: Given orally"
10830438|NCT00127205|OG000|Outcome|Arm I Zoledronic Acid|"Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.~zoledronic acid: Given IV"
10830439|NCT00127205|OG002|Outcome|Arm III Ibandronate|"Arm III Ibandronate~Patients receive oral ibandronate once daily for 35 months.~ibandronate sodium: Given orally"
10830440|NCT00127205|EG000|Reported Event|Arm I Zoledronic Acid|"Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.~zoledronic acid: Given IV"
10830441|NCT00127205|EG001|Reported Event|Arm II Clodronate|"Patients receive oral clodronate once daily for 35 months.~clodronate disodium: Given orally"
10830442|NCT00127205|EG002|Reported Event|Arm III Ibandronate|"Patients receive oral ibandronate once daily for 35 months.~ibandronate sodium: Given orally"
10830443|NCT00127218|BG000|Baseline|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830444|NCT00127218|BG001|Baseline|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830445|NCT00127218|BG002|Baseline|Total|Total of all reporting groups
10830446|NCT00127218|FG000|Participant Flow|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830447|NCT00127218|FG001|Participant Flow|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830448|NCT00127218|OG000|Outcome|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830449|NCT00127218|OG001|Outcome|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830450|NCT00127218|OG000|Outcome|Any Statin Plus Niacin|"any statin plus niacin~any statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months~niacin: long-acting niacin daily for 18 months"
10830451|NCT00127218|OG001|Outcome|Any Statin Plus Placebo|"any statin plus placebo~any statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months~Placebo: matching placebo pill daily for 18 months"
10830452|NCT00127218|EG000|Reported Event|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10830453|NCT00127218|EG001|Reported Event|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
10842642|NCT00248638|OG001|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
10842643|NCT00248638|EG000|Reported Event|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
10842644|NCT00248638|EG001|Reported Event|Standard|Participants given standard nutrition without glutamine dipeptide
10842645|NCT00248651|BG000|Baseline|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
10842646|NCT00248651|BG001|Baseline|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
10842647|NCT00248651|BG002|Baseline|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
10842648|NCT00248651|BG003|Baseline|Total|Total of all reporting groups
10842649|NCT00248651|FG000|Participant Flow|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
10842650|NCT00248651|FG001|Participant Flow|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
10842651|NCT00248651|FG002|Participant Flow|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
10842652|NCT00248651|OG000|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
10842653|NCT00248651|OG001|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
10842654|NCT00248651|OG002|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
10842655|NCT00248651|EG000|Reported Event|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
10842656|NCT00248651|EG001|Reported Event|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
10842657|NCT00248651|EG002|Reported Event|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
10842658|NCT00248781|BG000|Baseline|Arm 1|Telecommunications system for exercise
10842659|NCT00248781|BG001|Baseline|Arm 2|attention control (health education)
10830454|NCT00127231|BG000|Baseline|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
10830455|NCT00127231|BG001|Baseline|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
10830456|NCT00127231|BG002|Baseline|Total|Total of all reporting groups
10830457|NCT00127231|FG000|Participant Flow|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
10830458|NCT00127231|FG001|Participant Flow|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
10830459|NCT00127231|OG000|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
10830460|NCT00127231|OG001|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
10830461|NCT00127231|EG000|Reported Event|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
10830462|NCT00127231|EG001|Reported Event|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
10830463|NCT00127413|BG000|Baseline|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
10830464|NCT00127413|BG001|Baseline|Cognitive Processing Therapy-PTSD|Cognitive processing therapy for PTSD
10830465|NCT00127413|BG002|Baseline|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
10830466|NCT00127413|BG003|Baseline|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
10830467|NCT00127413|BG004|Baseline|Total|Total of all reporting groups
10830468|NCT00127413|FG000|Participant Flow|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
10830469|NCT00127413|FG001|Participant Flow|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
10830470|NCT00127413|FG002|Participant Flow|Cognitive Behavioral Therapy - Integrated|Integrated treatment for comorbid chronic pain and PTSD
10830471|NCT00127413|FG003|Participant Flow|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
10830472|NCT00127413|OG000|Outcome|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
10830473|NCT00127413|OG001|Outcome|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
10830474|NCT00127413|OG002|Outcome|Cognitive Behavioral Therapy - Integrated|Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD
10830475|NCT00127413|OG003|Outcome|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider
10830476|NCT00127413|EG000|Reported Event|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
10830477|NCT00127413|EG001|Reported Event|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
10830478|NCT00127413|EG002|Reported Event|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
10830479|NCT00127413|EG003|Reported Event|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
10830480|NCT00127439|BG000|Baseline|Robotic Assisted Locomotor Training|Robotic Assisted Locomotor Training - The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred using a robotic device to provide assistance for stepping and standing kinematics with partial body weight support on a treadmill.
10830481|NCT00127439|BG001|Baseline|Manually Assisted Locomotor Training|Manually Assisted Locomotor Training: The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred on a treadmill with partial body weight support and manual assist from 3-4 trainers to produce stepping and standing kinematics.
10830482|NCT00127439|BG002|Baseline|Total|Total of all reporting groups
10830483|NCT00127439|FG000|Participant Flow|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
10842660|NCT00248781|BG002|Baseline|Total|Total of all reporting groups
10830484|NCT00127439|FG001|Participant Flow|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
10830485|NCT00127439|OG000|Outcome|Robotic Assisted Locomotor Training|Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
10830486|NCT00127439|OG001|Outcome|Manually Assisted Locomotor Training|Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
10830487|NCT00127439|OG000|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
10830488|NCT00127439|OG001|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
10830489|NCT00127439|OG001|Outcome|Manually Assisted Locomotor Training|"A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.~The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs."
10830490|NCT00127439|EG000|Reported Event|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
10830491|NCT00127439|EG001|Reported Event|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The therapist and trainers manually provide the appropriate kinematics associated with standing and stepping.
10830492|NCT00127530|BG000|Baseline|Placebo- Sugar Pill|Placebo control group
10830493|NCT00127530|BG001|Baseline|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
10830494|NCT00127530|BG002|Baseline|Total|Total of all reporting groups
10830495|NCT00127530|FG000|Participant Flow|Placebo- Sugar Pill|Placebo control group
10830496|NCT00127530|FG001|Participant Flow|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
10830497|NCT00127530|OG000|Outcome|Placebo- Sugar Pill|Placebo control group
10830498|NCT00127530|OG001|Outcome|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
10830499|NCT00127530|EG000|Reported Event|Placebo- Sugar Pill|Placebo control group
10830500|NCT00127530|EG001|Reported Event|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
10830501|NCT00127608|BG000|Baseline|Varicella Group|Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
10830502|NCT00127608|FG000|Participant Flow|Varicella Group|Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
10830503|NCT00127608|OG000|Outcome|Varicella Group|Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
10830504|NCT00127608|EG000|Reported Event|Varicella Group|Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
10830505|NCT00127660|BG000|Baseline|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
10830506|NCT00127660|BG001|Baseline|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
10830507|NCT00127660|BG002|Baseline|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
10830508|NCT00127660|BG003|Baseline|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
10830509|NCT00127660|BG004|Baseline|Total|Total of all reporting groups
10830510|NCT00127660|FG000|Participant Flow|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
10830511|NCT00127660|FG001|Participant Flow|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
10830512|NCT00127660|FG002|Participant Flow|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
10830513|NCT00127660|FG003|Participant Flow|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
10830514|NCT00127660|OG000|Outcome|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
10830515|NCT00127660|OG001|Outcome|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
10830516|NCT00127660|OG002|Outcome|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
10830517|NCT00127660|OG003|Outcome|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
10830518|NCT00127660|EG000|Reported Event|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
10830519|NCT00127660|EG001|Reported Event|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
10830520|NCT00127660|EG002|Reported Event|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
10830521|NCT00127660|EG003|Reported Event|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
10830522|NCT00127712|BG000|Baseline|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
10830523|NCT00127712|BG001|Baseline|Control|Control group
10830524|NCT00127712|BG002|Baseline|Total|Total of all reporting groups
10830525|NCT00127712|FG000|Participant Flow|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
10830526|NCT00127712|FG001|Participant Flow|Control|Control group
10830527|NCT00127712|OG000|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
10830528|NCT00127712|OG001|Outcome|Control|Control group
10830529|NCT00127712|EG000|Reported Event|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
10830530|NCT00127712|EG001|Reported Event|Control|Control group
10830531|NCT00127790|BG000|Baseline|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
10830532|NCT00127790|BG001|Baseline|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830533|NCT00127790|BG002|Baseline|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830534|NCT00127790|BG003|Baseline|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
10830535|NCT00127790|BG004|Baseline|Total|Total of all reporting groups
10830536|NCT00127790|FG000|Participant Flow|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
10830537|NCT00127790|FG001|Participant Flow|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830538|NCT00127790|FG002|Participant Flow|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830539|NCT00127790|FG003|Participant Flow|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
10830540|NCT00127790|OG000|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
10830541|NCT00127790|OG001|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830542|NCT00127790|OG002|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830543|NCT00127790|OG003|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
10830544|NCT00127790|EG000|Reported Event|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
10830545|NCT00127790|EG001|Reported Event|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830546|NCT00127790|EG002|Reported Event|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
10830547|NCT00127790|EG003|Reported Event|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
10830548|NCT00127803|BG000|Baseline|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
10830549|NCT00127803|BG001|Baseline|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
10830550|NCT00127803|BG002|Baseline|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
10830551|NCT00127803|BG003|Baseline|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
10830552|NCT00127803|BG004|Baseline|Total|Total of all reporting groups
10830553|NCT00127803|FG000|Participant Flow|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
10830554|NCT00127803|FG001|Participant Flow|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
10830555|NCT00127803|FG002|Participant Flow|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
10830556|NCT00127803|FG003|Participant Flow|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
10830557|NCT00127803|OG000|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
10830558|NCT00127803|OG001|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
10830559|NCT00127803|OG002|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
10830560|NCT00127803|OG003|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
10830561|NCT00127803|EG000|Reported Event|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
10830562|NCT00127803|EG001|Reported Event|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
10830563|NCT00127803|EG002|Reported Event|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
10830564|NCT00127803|EG003|Reported Event|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
10830565|NCT00127842|BG000|Baseline|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
10830566|NCT00127842|FG000|Participant Flow|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
10830567|NCT00127842|OG000|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
10830568|NCT00127842|EG000|Reported Event|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
10830569|NCT00127855|BG000|Baseline|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830570|NCT00127855|BG001|Baseline|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830571|NCT00127855|BG002|Baseline|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830572|NCT00127855|BG003|Baseline|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830573|NCT00127855|BG004|Baseline|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830574|NCT00127855|BG005|Baseline|Total|Total of all reporting groups
10830575|NCT00127855|FG000|Participant Flow|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830576|NCT00127855|FG001|Participant Flow|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830577|NCT00127855|FG002|Participant Flow|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830578|NCT00127855|FG003|Participant Flow|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830579|NCT00127855|FG004|Participant Flow|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830580|NCT00127855|OG000|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830581|NCT00127855|OG001|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830582|NCT00127855|OG002|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830583|NCT00127855|OG003|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830584|NCT00127855|OG004|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830585|NCT00127855|EG000|Reported Event|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830586|NCT00127855|EG001|Reported Event|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830587|NCT00127855|EG002|Reported Event|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830588|NCT00127855|EG003|Reported Event|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830589|NCT00127855|EG004|Reported Event|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
10830590|NCT00127933|BG000|Baseline|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
10830591|NCT00127933|BG001|Baseline|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
10830592|NCT00127933|BG002|Baseline|Total|Total of all reporting groups
10830593|NCT00127933|FG000|Participant Flow|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
10830594|NCT00127933|FG001|Participant Flow|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
10830595|NCT00127933|OG000|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
10830596|NCT00127933|OG001|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
10830597|NCT00127933|EG000|Reported Event|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
10830598|NCT00127933|EG001|Reported Event|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
10830599|NCT00128102|BG000|Baseline|Vorinostat|Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830600|NCT00128102|BG001|Baseline|Placebo|Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830601|NCT00128102|BG002|Baseline|Total|Total of all reporting groups
10830602|NCT00128102|FG000|Participant Flow|Vorinostat|Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830603|NCT00128102|FG001|Participant Flow|Placebo|Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830604|NCT00128102|OG000|Outcome|Vorinostat|Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830605|NCT00128102|OG001|Outcome|Placebo|Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830606|NCT00128102|EG000|Reported Event|Vorinostat|Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830607|NCT00128102|EG001|Reported Event|Placebo|Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
10830608|NCT00128180|BG000|Baseline|Active|Active drug
10830609|NCT00128180|BG001|Baseline|Placebo|Placebo group
10830610|NCT00128180|BG002|Baseline|Total|Total of all reporting groups
10830611|NCT00128180|FG000|Participant Flow|Active|Active drug
10830612|NCT00128180|FG001|Participant Flow|Placebo|Placebo group
10830613|NCT00128180|OG000|Outcome|Active|Active drug
10830614|NCT00128180|OG001|Outcome|Placebo|Placebo group
10830615|NCT00128180|EG000|Reported Event|Active|Active drug
10830616|NCT00128180|EG001|Reported Event|Placebo|Placebo group
10830617|NCT00128193|BG000|Baseline|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
10830618|NCT00128193|BG001|Baseline|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830619|NCT00128193|BG002|Baseline|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830620|NCT00128193|BG003|Baseline|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830621|NCT00128193|BG004|Baseline|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830622|NCT00128193|BG005|Baseline|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830623|NCT00128193|BG006|Baseline|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830624|NCT00128193|BG007|Baseline|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830625|NCT00128193|BG008|Baseline|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830626|NCT00128193|BG009|Baseline|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830627|NCT00128193|BG010|Baseline|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830628|NCT00128193|BG011|Baseline|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830629|NCT00128193|BG012|Baseline|Total|Total of all reporting groups
10830630|NCT00128193|FG000|Participant Flow|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
10830631|NCT00128193|FG001|Participant Flow|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830632|NCT00128193|FG002|Participant Flow|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830633|NCT00128193|FG003|Participant Flow|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830634|NCT00128193|FG004|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830635|NCT00128193|FG005|Participant Flow|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830636|NCT00128193|FG006|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830637|NCT00128193|FG007|Participant Flow|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830638|NCT00128193|FG008|Participant Flow|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830639|NCT00128193|FG009|Participant Flow|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830640|NCT00128193|FG010|Participant Flow|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830641|NCT00128193|FG011|Participant Flow|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830642|NCT00128193|OG000|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
10830643|NCT00128193|OG001|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830644|NCT00128193|OG002|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10842661|NCT00248781|FG000|Participant Flow|Automated Exercise Group|Telecommunications system for exercise
10842662|NCT00248781|FG001|Participant Flow|Attention Control Group|attention control (health education)
10830645|NCT00128193|OG003|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830646|NCT00128193|OG004|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830647|NCT00128193|OG005|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830648|NCT00128193|OG000|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830649|NCT00128193|OG001|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830650|NCT00128193|OG002|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830651|NCT00128193|OG003|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830652|NCT00128193|OG004|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830653|NCT00128193|OG002|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830654|NCT00128193|OG003|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830655|NCT00128193|OG004|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830656|NCT00128193|OG005|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830657|NCT00128193|OG001|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830658|NCT00128193|OG002|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830659|NCT00128193|OG003|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830660|NCT00128193|OG004|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830661|NCT00128193|OG000|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830662|NCT00128193|OG001|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830663|NCT00128193|OG000|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830664|NCT00128193|OG000|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
10830665|NCT00128193|OG001|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830666|NCT00128193|OG002|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830667|NCT00128193|OG003|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830668|NCT00128193|OG004|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830669|NCT00128193|OG005|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830670|NCT00128193|OG006|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830671|NCT00128193|OG007|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830672|NCT00128193|OG008|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830673|NCT00128193|OG009|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830674|NCT00128193|OG010|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830675|NCT00128193|OG011|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830676|NCT00128193|OG002|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10842663|NCT00248781|OG000|Outcome|Automated Exercise Group|Telecommunications system for exercise
10842664|NCT00248781|OG001|Outcome|Attention Control Group|attention control (health education)
11328301|NCT03426436|BG000|Baseline|Test|"Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.~Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side."
11328302|NCT03426436|FG000|Participant Flow|Test|"Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.~Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side."
11336115|NCT03561090|BG000|Baseline|Placebo BID + PPI|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336116|NCT03561090|BG001|Baseline|1500 mg IW-3718 BID + PPI|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336117|NCT03561090|BG002|Baseline|Total|Total of all reporting groups
11336118|NCT03561090|FG000|Participant Flow|Placebo BID + PPI|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose proton pump inhibitors (PPIs) administered QD approximately 30-60 minutes before the morning meal each day.
11336119|NCT03561090|FG001|Participant Flow|1500 mg IW-3718 BID + PPI|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336120|NCT03561090|OG000|Outcome|Placebo BID + PPI|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336121|NCT03561090|OG001|Outcome|1500 mg IW-3718 BID + PPI|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336122|NCT03561090|OG000|Outcome|Placebo BID + PPI|Three placebo tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336123|NCT03561090|OG001|Outcome|1500 mg IW-3718 BID + PPI|Three 1500 mg IW-3718 tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336124|NCT03561090|EG000|Reported Event|Placebo BID + PPI|Three placebo tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336125|NCT03561090|EG001|Reported Event|1500 mg IW-3718 BID + PPI|Three 1500 mg IW-3718 tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336126|NCT03561883|BG000|Baseline|Placebo BID + PPIs|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336127|NCT03561883|BG001|Baseline|1500 mg IW-3718 BID + PPIs|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336128|NCT03561883|BG002|Baseline|Total|Total of all reporting groups
11336129|NCT03561883|FG000|Participant Flow|Placebo BID + PPIs|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose proton pump inhibitors (PPIs) administered once-daily (QD) approximately 30-60 minutes before the morning meal each day.
11336130|NCT03561883|FG001|Participant Flow|1500 mg IW-3718 BID + PPIs|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
11336131|NCT03561883|OG000|Outcome|Placebo BID + PPIs|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day.
11336132|NCT03561883|OG001|Outcome|1500 mg IW-3718 BID + PPIs|Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day.
11336133|NCT03561883|EG000|Reported Event|Placebo BID + PPIs|Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day.
11336134|NCT03561883|EG001|Reported Event|1500 mg IW-3718 BID + PPIs|Three IW-3718 tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day.
11336135|NCT03562117|BG000|Baseline|Participants With Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336136|NCT03562117|BG001|Baseline|Participants With Moderate Hepatic Impairment|Participants with moderate hepatic function having Child-Pugh score of 7 to 9 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336137|NCT03562117|BG002|Baseline|Participants With Severe Hepatic Impairment|Participants with severe hepatic function having Child-Pugh score of 10 to 15 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336138|NCT03562117|BG003|Baseline|Total|Total of all reporting groups
11336139|NCT03562117|FG000|Participant Flow|Participants With Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
10830677|NCT00128193|OG003|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830678|NCT00128193|OG004|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830679|NCT00128193|OG005|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830680|NCT00128193|OG006|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830681|NCT00128193|OG007|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830682|NCT00128193|OG008|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830683|NCT00128193|OG009|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830684|NCT00128193|OG000|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830685|NCT00128193|OG001|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830686|NCT00128193|OG002|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830687|NCT00128193|OG000|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830688|NCT00128193|OG001|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830689|NCT00128193|OG002|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830690|NCT00128193|OG003|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830691|NCT00128193|OG000|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830692|NCT00128193|OG001|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830693|NCT00128193|OG002|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830694|NCT00128193|OG004|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830695|NCT00128193|OG005|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830696|NCT00128193|OG006|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830697|NCT00128193|OG007|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830698|NCT00128193|OG001|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830699|NCT00128193|OG002|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830700|NCT00128193|OG003|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830701|NCT00128193|OG001|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830702|NCT00128193|OG000|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830703|NCT00128193|OG000|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830704|NCT00128193|OG001|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830705|NCT00128193|OG002|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830706|NCT00128193|OG003|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
10830707|NCT00128193|OG004|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830708|NCT00128193|EG000|Reported Event|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
10842665|NCT00248781|EG000|Reported Event|Automated Exercise Group|Telecommunications system for exercise
10842666|NCT00248781|EG001|Reported Event|Attention Control Group|attention control (health education)
10830709|NCT00128193|EG001|Reported Event|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830710|NCT00128193|EG002|Reported Event|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830711|NCT00128193|EG003|Reported Event|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
10830712|NCT00128193|EG004|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830713|NCT00128193|EG005|Reported Event|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830714|NCT00128193|EG006|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830715|NCT00128193|EG007|Reported Event|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
10830716|NCT00128193|EG008|Reported Event|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
10830717|NCT00128193|EG009|Reported Event|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830718|NCT00128193|EG010|Reported Event|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830719|NCT00128193|EG011|Reported Event|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
10830720|NCT00128206|BG000|Baseline|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
10830721|NCT00128206|BG001|Baseline|Rifampin|rifampin (600 mg orally) given daily for 4 months
10830722|NCT00128206|BG002|Baseline|Total|Total of all reporting groups
10830723|NCT00128206|FG000|Participant Flow|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
10830724|NCT00128206|FG001|Participant Flow|Rifampin|rifampin (600 mg orally) given daily for 4 months
10830725|NCT00128206|OG000|Outcome|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
10830726|NCT00128206|OG001|Outcome|Rifampin|rifampin (600 mg orally) given daily for 4 months
10830727|NCT00128206|EG000|Reported Event|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
10830728|NCT00128206|EG001|Reported Event|Rifampin|rifampin (600 mg orally) given daily for 4 months
10830729|NCT00128219|BG000|Baseline|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
10830730|NCT00128219|BG001|Baseline|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
10830731|NCT00128219|BG002|Baseline|Total|Total of all reporting groups
10830732|NCT00128219|FG000|Participant Flow|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
10830733|NCT00128219|FG001|Participant Flow|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
10830734|NCT00128219|OG000|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
10830735|NCT00128219|OG001|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
10830736|NCT00128219|EG000|Reported Event|GBS III-TT Vaccine|The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
10830737|NCT00128219|EG001|Reported Event|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
10830738|NCT00128401|BG000|Baseline|D-cycloserine|
10830739|NCT00128401|BG001|Baseline|Placebo|
10830740|NCT00128401|BG002|Baseline|Total|Total of all reporting groups
10830741|NCT00128401|FG000|Participant Flow|D-cycloserine|Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
10842667|NCT00248794|BG000|Baseline|CRT +Skills Group|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
10842668|NCT00248794|BG001|Baseline|ICBCR + Skills Group|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
10842669|NCT00248794|BG002|Baseline|Skills Group Only|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
10842670|NCT00248794|BG003|Baseline|Total|Total of all reporting groups
10842671|NCT00248794|FG000|Participant Flow|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
10830742|NCT00128401|FG001|Participant Flow|Placebo|"Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.~All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent."
10830743|NCT00128401|OG000|Outcome|D-cycloserine|
10830744|NCT00128401|OG001|Outcome|Placebo|
10830745|NCT00128401|EG000|Reported Event|D-cycloserine|
10830746|NCT00128401|EG001|Reported Event|Placebo|
10830747|NCT00128401|EG002|Reported Event|Not Assigned|
10830748|NCT00128492|BG000|Baseline|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
10830749|NCT00128492|BG001|Baseline|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
10830750|NCT00128492|BG002|Baseline|Total|Total of all reporting groups
10830751|NCT00128492|FG000|Participant Flow|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
10830752|NCT00128492|FG001|Participant Flow|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
11336140|NCT03562117|FG001|Participant Flow|Participants With Moderate Hepatic Impairment|Participants with moderate hepatic function having Child-Pugh score of 7 to 9 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
10830753|NCT00128492|OG000|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
10830754|NCT00128492|OG001|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
10830755|NCT00128492|EG000|Reported Event|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
10830756|NCT00128492|EG001|Reported Event|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
10830757|NCT00128661|BG000|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830758|NCT00128661|BG001|Baseline|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830759|NCT00128661|BG002|Baseline|Total|Total of all reporting groups
10830760|NCT00128661|FG000|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830761|NCT00128661|FG001|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830762|NCT00128661|OG000|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830763|NCT00128661|OG001|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830764|NCT00128661|EG000|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830765|NCT00128661|EG001|Reported Event|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
10830766|NCT00128713|BG000|Baseline|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830767|NCT00128713|BG001|Baseline|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830768|NCT00128713|BG002|Baseline|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830769|NCT00128713|BG003|Baseline|Total|Total of all reporting groups
10830770|NCT00128713|FG000|Participant Flow|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830771|NCT00128713|FG001|Participant Flow|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830772|NCT00128713|FG002|Participant Flow|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830773|NCT00128713|OG000|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830774|NCT00128713|OG001|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830775|NCT00128713|OG002|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830776|NCT00128713|EG000|Reported Event|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830777|NCT00128713|EG001|Reported Event|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830778|NCT00128713|EG002|Reported Event|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
10830779|NCT00128830|BG000|Baseline|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
10830780|NCT00128830|FG000|Participant Flow|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
10830781|NCT00128830|OG000|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
10830782|NCT00128830|OG001|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
10830783|NCT00128830|OG000|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
10830784|NCT00128830|EG000|Reported Event|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
10830785|NCT00128921|BG000|Baseline|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
10830786|NCT00128921|BG001|Baseline|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
10830787|NCT00128921|BG002|Baseline|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
10830788|NCT00128921|BG003|Baseline|Total|Total of all reporting groups
10830789|NCT00128921|FG000|Participant Flow|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
10830790|NCT00128921|FG001|Participant Flow|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
10830791|NCT00128921|FG002|Participant Flow|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
10830792|NCT00128921|OG000|Outcome|Cohort A|Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
10830793|NCT00128921|OG001|Outcome|Cohort B|Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
10830794|NCT00128921|OG000|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
10830795|NCT00128921|OG001|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
10830796|NCT00128921|OG001|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
10830797|NCT00128921|EG000|Reported Event|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
10830798|NCT00128921|EG001|Reported Event|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
10830799|NCT00128921|EG002|Reported Event|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
10830800|NCT00129116|BG000|Baseline|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830801|NCT00129116|BG001|Baseline|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830802|NCT00129116|BG002|Baseline|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830803|NCT00129116|BG003|Baseline|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830804|NCT00129116|BG004|Baseline|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830805|NCT00129116|BG005|Baseline|Total|Total of all reporting groups
10830806|NCT00129116|FG000|Participant Flow|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830807|NCT00129116|FG001|Participant Flow|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10842672|NCT00248794|FG001|Participant Flow|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
10830808|NCT00129116|FG002|Participant Flow|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830809|NCT00129116|FG003|Participant Flow|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830810|NCT00129116|FG004|Participant Flow|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830811|NCT00129116|OG000|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830812|NCT00129116|OG001|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830813|NCT00129116|OG002|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830814|NCT00129116|OG003|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830815|NCT00129116|OG004|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830816|NCT00129116|EG000|Reported Event|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830817|NCT00129116|EG001|Reported Event|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830818|NCT00129116|EG002|Reported Event|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830819|NCT00129116|EG003|Reported Event|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830820|NCT00129116|EG004|Reported Event|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
10830821|NCT00129129|BG000|Baseline|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..
10830822|NCT00129129|BG001|Baseline|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
10830823|NCT00129129|BG002|Baseline|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
10830824|NCT00129129|BG003|Baseline|Total|Total of all reporting groups
10830825|NCT00129129|FG000|Participant Flow|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
10830826|NCT00129129|FG001|Participant Flow|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
10830827|NCT00129129|FG002|Participant Flow|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
10830828|NCT00129129|FG003|Participant Flow|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
10830829|NCT00129129|FG004|Participant Flow|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830830|NCT00129129|OG000|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
10830831|NCT00129129|OG001|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
10830832|NCT00129129|OG001|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10842673|NCT00248794|FG002|Participant Flow|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
10830833|NCT00129129|OG002|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
10830834|NCT00129129|OG000|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
10830835|NCT00129129|OG000|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
10830836|NCT00129129|OG001|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830837|NCT00129129|OG002|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830838|NCT00129129|OG000|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
10830839|NCT00129129|OG002|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
10830840|NCT00129129|OG002|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830841|NCT00129129|OG000|Outcome|Menhibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
10830842|NCT00129129|OG002|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830843|NCT00129129|EG000|Reported Event|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
10830844|NCT00129129|EG001|Reported Event|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
10830845|NCT00129129|EG002|Reported Event|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
10830846|NCT00129129|EG003|Reported Event|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830847|NCT00129129|EG004|Reported Event|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
10830848|NCT00129220|BG000|Baseline|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
10830849|NCT00129220|BG001|Baseline|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
10830850|NCT00129220|BG002|Baseline|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
10830851|NCT00129220|BG003|Baseline|Total|Total of all reporting groups
10830852|NCT00129220|FG000|Participant Flow|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
10830853|NCT00129220|FG001|Participant Flow|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
10830854|NCT00129220|FG002|Participant Flow|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
10830855|NCT00129220|OG000|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
10830856|NCT00129220|OG001|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
10830857|NCT00129220|OG002|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
10830858|NCT00129220|OG000|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day
10830859|NCT00129220|OG001|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day
10830860|NCT00129220|EG000|Reported Event|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
10830861|NCT00129220|EG001|Reported Event|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
10830862|NCT00129220|EG002|Reported Event|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
10830863|NCT00129246|BG000|Baseline|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830864|NCT00129246|BG001|Baseline|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830865|NCT00129246|BG002|Baseline|Total|Total of all reporting groups
10830866|NCT00129246|FG000|Participant Flow|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830867|NCT00129246|FG001|Participant Flow|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830868|NCT00129246|OG000|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830869|NCT00129246|OG001|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830870|NCT00129246|EG000|Reported Event|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830871|NCT00129246|EG001|Reported Event|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
10830872|NCT00129259|BG000|Baseline|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830873|NCT00129259|BG001|Baseline|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830874|NCT00129259|BG002|Baseline|Total|Total of all reporting groups
10830875|NCT00129259|FG000|Participant Flow|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|"Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
10830876|NCT00129259|FG001|Participant Flow|Diabetes Standard of Care Treatment|"Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
10830877|NCT00129259|OG000|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830878|NCT00129259|OG001|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830879|NCT00129259|EG000|Reported Event|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830880|NCT00129259|EG001|Reported Event|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
10830881|NCT00129272|BG000|Baseline|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
10830882|NCT00129272|BG001|Baseline|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
10830883|NCT00129272|BG002|Baseline|Total|Total of all reporting groups
10843062|NCT00251719|EG000|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
10843063|NCT00251719|EG001|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
10843064|NCT00251719|EG002|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
10843065|NCT00251745|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10830884|NCT00129272|FG000|Participant Flow|Active Drug (Burpropion-SR)|"In total 172 participants were recruited, and 144 were randomized.~Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron's biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.~Participants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment."
10830885|NCT00129272|FG001|Participant Flow|Matching Placebo|"This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.~All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy."
10830886|NCT00129272|OG000|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
10830887|NCT00129272|OG001|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
10830888|NCT00129272|EG000|Reported Event|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
10830889|NCT00129272|EG001|Reported Event|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
10830890|NCT00129285|BG000|Baseline|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: modafinil 200 mg/day"
10830891|NCT00129285|BG001|Baseline|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: modafinil 400 mg/day"
10830892|NCT00129285|BG002|Baseline|Placebo|"Placebo~Placebo: placebo 400 mg/day"
10830893|NCT00129285|BG003|Baseline|Total|Total of all reporting groups
10830894|NCT00129285|FG000|Participant Flow|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: participants received modafinil 200 mg/day"
10830895|NCT00129285|FG001|Participant Flow|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: participants received modafinil 400 mg/day"
10830896|NCT00129285|FG002|Participant Flow|Placebo|"Placebo~Placebo: participants received placebo 400 mg/day"
10830897|NCT00129285|OG000|Outcome|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: participants received modafinil 200 mg/day"
10830898|NCT00129285|OG001|Outcome|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: participants received modafinil 400 mg/day"
10830899|NCT00129285|OG002|Outcome|Placebo|"Placebo~Placebo: participants received placebo 400 mg/day"
10830900|NCT00129285|OG000|Outcome|1Low Dose Modafinil|"Low Dose Modafinil 200 mg daily~Modafinil Low Dose: modafinil 200 mg/day"
10830901|NCT00129285|OG001|Outcome|2 High Dose Modafinil|"High Dose Modafinil 400 mg daily~Modafinil High Dose: modafinil 400 mg/day"
10830902|NCT00129285|OG002|Outcome|3. Placebo|"Placebo~Placebo: placebo 400 mg/day"
10830903|NCT00129285|OG002|Outcome|Placebo|received placebo
10830904|NCT00129285|EG000|Reported Event|Modafinil High Dose|Modafinil 400 mg daily
10830905|NCT00129285|EG001|Reported Event|Placebo|Placebo daily
10830906|NCT00129285|EG002|Reported Event|Modafinil Low Dose|modafinil 200 mg daily
10830907|NCT00129311|BG000|Baseline|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830908|NCT00129311|BG001|Baseline|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830909|NCT00129311|BG002|Baseline|Total|Total of all reporting groups
10830910|NCT00129311|FG000|Participant Flow|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830911|NCT00129311|FG001|Participant Flow|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10843066|NCT00251745|BG001|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843067|NCT00251745|BG002|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843068|NCT00251745|BG003|Baseline|Total|Total of all reporting groups
10843069|NCT00251745|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843070|NCT00251745|FG001|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843071|NCT00251745|FG002|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843072|NCT00251745|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843073|NCT00251745|OG001|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843074|NCT00251745|OG002|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843075|NCT00251745|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843076|NCT00251745|EG001|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843077|NCT00251745|EG002|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843078|NCT00251758|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843079|NCT00251758|BG001|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843080|NCT00251758|BG002|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843081|NCT00251758|BG003|Baseline|Total|Total of all reporting groups
10843082|NCT00251758|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843083|NCT00251758|FG001|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843084|NCT00251758|FG002|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843085|NCT00251758|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843086|NCT00251758|OG001|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843087|NCT00251758|OG002|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843088|NCT00251758|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
10843089|NCT00251758|EG001|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
10843090|NCT00251758|EG002|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
10843091|NCT00251862|BG000|Baseline|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
10843092|NCT00251862|BG001|Baseline|DA Alone|Decision aid alone
10843093|NCT00251862|BG002|Baseline|Control|Standard Care
10843094|NCT00251862|BG003|Baseline|Total|Total of all reporting groups
10843095|NCT00251862|FG000|Participant Flow|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
10843096|NCT00251862|FG001|Participant Flow|DA Alone|Decision aid alone
10843097|NCT00251862|FG002|Participant Flow|Control|Standard Care
10843098|NCT00251862|OG000|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
10843099|NCT00251862|OG001|Outcome|DA Alone|Decision aid alone
10843100|NCT00251862|OG002|Outcome|Control|Standard Care
10843101|NCT00251862|EG000|Reported Event|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
10843102|NCT00251862|EG001|Reported Event|DA Alone|Decision aid alone
10843103|NCT00251862|EG002|Reported Event|Control|Standard Care
10843104|NCT00251927|BG000|Baseline|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
10843105|NCT00251927|BG001|Baseline|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
10843106|NCT00251927|BG002|Baseline|Total|Total of all reporting groups
10843107|NCT00251927|FG000|Participant Flow|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
10843108|NCT00251927|FG001|Participant Flow|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
10843109|NCT00251927|OG000|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
10843110|NCT00251927|OG001|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
10843111|NCT00251927|EG000|Reported Event|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
10843112|NCT00251927|EG001|Reported Event|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
10843113|NCT00251927|EG002|Reported Event|Non-Surgical Arm|This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
10843114|NCT00251979|BG000|Baseline|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843115|NCT00251979|BG001|Baseline|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843116|NCT00251979|BG002|Baseline|Total|Total of all reporting groups
10843117|NCT00251979|FG000|Participant Flow|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
11095246|NCT01557244|FG001|Participant Flow|Cohort 1: Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.
11095247|NCT01557244|FG002|Participant Flow|Cohort 1: Oxybutynin|Participants with body weight >25 kg were randomized to receive oxybutynin extended release (ER) tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.
11095248|NCT01557244|FG003|Participant Flow|Cohort 1: Oxybutynin Then Fesoterodine 4 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.
11095249|NCT01557244|FG004|Participant Flow|Cohort 1: Oxybutynin Then Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated then participants were withdrawn from the study.
11095250|NCT01557244|FG005|Participant Flow|Cohort 2: Fesoterodine 2 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.
11095251|NCT01557244|FG006|Participant Flow|Cohort 2: Fesoterodine 2 mg Then 4 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.
11095252|NCT01557244|OG000|Outcome|Cohort 1, Active Comparator Phase: Fesoterodine 4 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.
11095253|NCT01557244|OG001|Outcome|Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
11095254|NCT01557244|OG002|Outcome|Cohort 1, Active Comparator Phase: Oxybutynin|Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.
11095255|NCT01557244|OG003|Outcome|Cohort 2, Efficacy Phase: Fesoterodine 2 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.
11095256|NCT01557244|OG004|Outcome|Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
11095257|NCT01557244|OG000|Outcome|Cohort 1, Safety Extension Phase: Fesoterodine 4 mg|Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.
11095258|NCT01557244|OG001|Outcome|Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg|Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.
11095259|NCT01557244|OG002|Outcome|Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.
11095260|NCT01557244|OG003|Outcome|Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.
11095261|NCT01557244|OG004|Outcome|Cohort 2, Safety Extension Phase: Fesoterodine 2 mg|Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
11095262|NCT01557244|OG005|Outcome|Cohort 2, Safety Extension Phase: Fesoterodine 4 mg|Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
11095263|NCT01557244|OG001|Outcome|Cohort 1, Safety Extension Phase: Fesoterodine 8 mg|Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.
11095264|NCT01557244|OG004|Outcome|Cohort 2, Safety Extension Phase: Fesoterodine 2 mg|Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase
11095265|NCT01557244|OG003|Outcome|Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin 5 mg ER tablets orally once daily in active comparator phase, were allocated by investigator to receive fesoterodine 8 mg for 12 weeks in safety extension phase.
11095266|NCT01557244|OG000|Outcome|Fesoterodine Pooled|Participants received any dose of fesoterodine in the study from Week 1 to Week 24.
11095267|NCT01557244|EG000|Reported Event|Cohort 1, Active Comparator Phase: Fesoterodine 4 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.
11095268|NCT01557244|EG001|Reported Event|Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg|Participants with body weight >25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
11095269|NCT01557244|EG002|Reported Event|Cohort 1, Active Comparator Phase: Oxybutynin|Participants with body weight >25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.
11095270|NCT01557244|EG003|Reported Event|Cohort 1, Safety Extension Phase: Fesoterodine 4 mg|Participants with body weight >25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.
11095271|NCT01557244|EG004|Reported Event|Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg|Participants with body weight >25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.
11095272|NCT01557244|EG005|Reported Event|Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.
11095273|NCT01557244|EG006|Reported Event|Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg|Participants with body weight >25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.
11095274|NCT01557244|EG007|Reported Event|Cohort 2, Efficacy Phase: Fesoterodine 2 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.
11095275|NCT01557244|EG008|Reported Event|Cohort 2 Efficacy Phase: Fesoterodine 4 mg|Participants with body weight <=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.
11095276|NCT01557244|EG009|Reported Event|Cohort 2, Safety Extension Phase: Fesoterodine 2 mg|Participants with body weight <=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
11095277|NCT01557244|EG010|Reported Event|Cohort 2, Safety Extension Phase: Fesoterodine 4 mg|Participants with body weight <=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
11095278|NCT01557283|BG000|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
11095279|NCT01557283|FG000|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
11095280|NCT01557283|OG000|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
11095281|NCT01557283|EG000|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
11095282|NCT01557322|BG000|Baseline|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11336141|NCT03562117|FG002|Participant Flow|Participants With Severe Hepatic Impairment|Participants with severe hepatic function having Child-Pugh score of 10 to 15 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11095283|NCT01557322|BG001|Baseline|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095284|NCT01557322|BG002|Baseline|Total|Total of all reporting groups
11095285|NCT01557322|FG000|Participant Flow|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095286|NCT01557322|FG001|Participant Flow|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095287|NCT01557322|OG000|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095288|NCT01557322|OG001|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095289|NCT01557322|EG000|Reported Event|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095290|NCT01557322|EG001|Reported Event|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
11095291|NCT01557348|BG000|Baseline|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095292|NCT01557348|BG001|Baseline|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095293|NCT01557348|BG002|Baseline|Total|Total of all reporting groups
11095294|NCT01557348|FG000|Participant Flow|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095295|NCT01557348|FG001|Participant Flow|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095296|NCT01557348|OG000|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095297|NCT01557348|OG001|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095298|NCT01557348|OG001|Outcome|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095299|NCT01557348|EG000|Reported Event|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095300|NCT01557348|EG001|Reported Event|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
11095301|NCT01557400|BG000|Baseline|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, milk, fruit juice (except apple juice) fruit punch, or in semi-solid food (for example, yogurt, pudding, or applesauce). The dose level for ataluren was 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug dosing was based on milligrams of drug per kilogram of body weight. Because of potential changes in participant body weight over time, weight-based dose adjustment occurred every 24 weeks as required. Study drug was taken for up to 240 weeks.
11328303|NCT03426436|OG000|Outcome|All Participants|"Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.~Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side."
11336142|NCT03562117|OG000|Outcome|Participants With Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336143|NCT03562117|OG001|Outcome|Participants With Moderate Hepatic Impairment|Participants with moderate hepatic function having Child-Pugh score of 7 to 9 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11095302|NCT01557400|FG000|Participant Flow|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, milk, fruit juice (except apple juice) fruit punch, or in semi-solid food (for example, yogurt, pudding, or applesauce). The dose level for ataluren was 10 milligrams/kilograms (mg/kg) in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug dosing was based on milligrams of drug per kilogram of body weight. Because of potential changes in participant body weight over time, weight-based dose adjustment occurred every 24 weeks as required. Study drug was taken for up to 240 weeks.
11095303|NCT01557400|OG000|Outcome|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, milk, fruit juice (except apple juice) fruit punch, or in semi-solid food (for example, yogurt, pudding, or applesauce). The dose level for ataluren was 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug dosing was based on milligrams of drug per kilogram of body weight. Because of potential changes in participant body weight over time, weight-based dose adjustment occurred every 24 weeks as required. Study drug was taken for up to 240 weeks.
11095304|NCT01557400|EG000|Reported Event|Ataluren|Ataluren was provided as a vanilla-flavored powder to be mixed with water, milk, fruit juice (except apple juice) fruit punch, or in semi-solid food (for example, yogurt, pudding, or applesauce). The dose level for ataluren was 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening. Administration within 30 minutes after a meal was recommended. Study drug dosing was based on milligrams of drug per kilogram of body weight. Because of potential changes in participant body weight over time, weight-based dose adjustment occurred every 24 weeks as required. Study drug was taken for up to 240 weeks.
11095305|NCT01557452|BG000|Baseline|Givinostat|Givinostat: oral suspension, 0,75 mg/Kg b.i.d. in fed conditions
11095306|NCT01557452|FG000|Participant Flow|Givinostat|Givinostat: oral suspension, 0,75 mg/Kg b.i.d. in fed conditions
11095307|NCT01557452|OG000|Outcome|Givinostat|Givinostat: oral suspension, 0,75 mg/Kg b.i.d. in fed conditions
11095308|NCT01557452|OG000|Outcome|Givinostat|Givinostat: oral suspension, 0,75 mg/kg b.i.d. in fed conditions
11095309|NCT01557452|EG000|Reported Event|Givinostat|Givinostat: oral suspension, 0,75 mg/kg b.i.d. in fed conditions
11095310|NCT01557504|BG000|Baseline|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095311|NCT01557504|BG001|Baseline|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095312|NCT01557504|BG002|Baseline|Total|Total of all reporting groups
11095313|NCT01557504|FG000|Participant Flow|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095314|NCT01557504|FG001|Participant Flow|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095315|NCT01557504|OG000|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
11095316|NCT01557504|OG000|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 4.
11095317|NCT01557504|OG000|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 6.
11095318|NCT01557504|OG000|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 9.
11095319|NCT01557504|OG000|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095320|NCT01557504|OG000|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095321|NCT01557504|OG001|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095322|NCT01557504|OG001|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095323|NCT01557504|EG000|Reported Event|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095324|NCT01557504|EG001|Reported Event|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
11095325|NCT01557517|BG000|Baseline|Clobetasol|"Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.~Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day."
10830912|NCT00129311|OG000|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830913|NCT00129311|OG001|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830914|NCT00129311|EG000|Reported Event|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830915|NCT00129311|EG001|Reported Event|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
10830916|NCT00129376|BG000|Baseline|Doxorubicin + Cyclophosphamide Followed Docetaxel|Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).
10830917|NCT00129376|FG000|Participant Flow|Doxorubicin + Cyclophosphamide Followed Docetaxel|Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).
10830918|NCT00129376|OG000|Outcome|Doxorubicin + Cyclophosphamide Followed Docetaxel|Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).
10830919|NCT00129376|EG000|Reported Event|Doxorubicin + Cyclophosphamide Followed Docetaxel|Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).
10830920|NCT00129389|BG000|Baseline|Arm A: FAC|FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
10830921|NCT00129389|BG001|Baseline|Arm B: FAC-wP|FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
10830922|NCT00129389|BG002|Baseline|Total|Total of all reporting groups
10830923|NCT00129389|FG000|Participant Flow|Arm A: FAC|FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
10830924|NCT00129389|FG001|Participant Flow|Arm B: FAC-wP|FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
10830925|NCT00129389|OG000|Outcome|Arm A: FAC|FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
10830926|NCT00129389|OG001|Outcome|Arm B: FAC-wP|FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
10830927|NCT00129389|EG000|Reported Event|Arm A: FAC|FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
10830928|NCT00129389|EG001|Reported Event|Arm B: FAC-wP|FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
10830929|NCT00129441|BG000|Baseline|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
10830930|NCT00129441|BG001|Baseline|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
10830931|NCT00129441|BG002|Baseline|Total|Total of all reporting groups
10830932|NCT00129441|FG000|Participant Flow|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
10830933|NCT00129441|FG001|Participant Flow|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
10830934|NCT00129441|OG000|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
10843118|NCT00251979|FG001|Participant Flow|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843119|NCT00251979|OG000|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843120|NCT00251979|OG001|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843121|NCT00251979|EG000|Reported Event|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843122|NCT00251979|EG001|Reported Event|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
10843123|NCT00252057|BG000|Baseline|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
10843124|NCT00252057|BG001|Baseline|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
10843125|NCT00252057|BG002|Baseline|Total|Total of all reporting groups
10843126|NCT00252057|FG000|Participant Flow|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
10843127|NCT00252057|FG001|Participant Flow|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
10843128|NCT00252057|OG000|Outcome|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
10843129|NCT00252057|OG001|Outcome|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
10843130|NCT00252057|EG000|Reported Event|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
10843131|NCT00252057|EG001|Reported Event|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
10843132|NCT00252187|BG000|Baseline|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
10843133|NCT00252187|BG001|Baseline|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
10843134|NCT00252187|BG002|Baseline|Total|Total of all reporting groups
10843135|NCT00252187|FG000|Participant Flow|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
10843136|NCT00252187|FG001|Participant Flow|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
10843137|NCT00252187|OG000|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
10843138|NCT00252187|OG001|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
10843139|NCT00252187|EG000|Reported Event|BPN Group|BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
10843140|NCT00252187|EG001|Reported Event|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks
10843141|NCT00252239|BG000|Baseline|TNK 0.1 mg/kg|Lowest dose tenecteplase
10843142|NCT00252239|BG001|Baseline|TNK 0.25 mg/kg|Medium dose tenecteplase
10843143|NCT00252239|BG002|Baseline|TNK 0.4 mg/kg|Highest dose tenecteplase
10843144|NCT00252239|BG003|Baseline|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
10843145|NCT00252239|BG004|Baseline|Total|Total of all reporting groups
10843146|NCT00252239|FG000|Participant Flow|TNK 0.1 mg/kg|Lowest dose tenecteplase
10843147|NCT00252239|FG001|Participant Flow|TNK 0.25 mg/kg|Medium dose tenecteplase
10843148|NCT00252239|FG002|Participant Flow|TNK 0.4 mg/kg|Highest dose tenecteplase
10843149|NCT00252239|FG003|Participant Flow|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
10843150|NCT00252239|OG000|Outcome|TNK 0.1 mg/kg|Lowest dose tenecteplase
10843151|NCT00252239|OG001|Outcome|TNK 0.25 mg/kg|Medium dose tenecteplase
10843152|NCT00252239|OG002|Outcome|TNK 0.4 mg/kg|Highest dose tenecteplase
10843153|NCT00252239|OG003|Outcome|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
10843154|NCT00252239|EG000|Reported Event|TNK 0.1 mg/kg|Lowest dose tenecteplase
10843155|NCT00252239|EG001|Reported Event|TNK 0.25 mg/kg|Medium dose tenecteplase
10843156|NCT00252239|EG002|Reported Event|TNK 0.4 mg/kg|Highest dose tenecteplase
10843157|NCT00252239|EG003|Reported Event|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
10843158|NCT00252382|BG000|Baseline|Total|Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.
10843159|NCT00252382|FG000|Participant Flow|Treatment With 48 mg/m2 of SNS-595|"Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)~SNS-595 Injection: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis."
10843160|NCT00252382|OG000|Outcome|Total|SNS-595 48 mg/m2
10843161|NCT00252382|EG000|Reported Event|Total|SNS-595 48 mg/m2
10843162|NCT00252499|BG000|Baseline|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
10843163|NCT00252499|BG001|Baseline|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
11095326|NCT01557517|BG001|Baseline|Placebo|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095327|NCT01557517|BG002|Baseline|Total|Total of all reporting groups
11095328|NCT01557517|FG000|Participant Flow|Clobetasol Followed by Assessment + 2 Weeks Clobetasol|"Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.~Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day."
11095329|NCT01557517|FG001|Participant Flow|Placebo Followed by Clobetasol|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095330|NCT01557517|OG000|Outcome|Clobetasol (2-week)|"Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.~Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day."
11095331|NCT01557517|OG001|Outcome|Placebo (2-week)|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095332|NCT01557517|OG002|Outcome|Combined Group 4-week Data|Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
11095333|NCT01557517|OG000|Outcome|Clobetasol|"Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.~Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day."
11095334|NCT01557517|OG001|Outcome|Placebo|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095335|NCT01557517|OG000|Outcome|Combined Group 4-week Data|Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
11095336|NCT01557517|OG001|Outcome|Placebo First (During Clobetasol Phase Only)|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095337|NCT01557517|OG002|Outcome|Placebo (During 2-week Placebo Phase Only)|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095338|NCT01557517|EG000|Reported Event|Clobetasol|"Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.~Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day."
11095339|NCT01557517|EG001|Reported Event|Placebo First (During Clobetasol Phase Only)|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11095340|NCT01557517|EG002|Reported Event|Placebo (During 2-week Placebo Phase Only)|"Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.~Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day."
11328304|NCT03426436|EG000|Reported Event|Test|"Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.~Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side."
11095341|NCT01557569|BG000|Baseline|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
11095342|NCT01557569|BG001|Baseline|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
11095343|NCT01557569|BG002|Baseline|Total|Total of all reporting groups
11095344|NCT01557569|FG000|Participant Flow|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
11095345|NCT01557569|FG001|Participant Flow|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
11095346|NCT01557569|OG000|Outcome|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
11095347|NCT01557569|OG001|Outcome|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
11328305|NCT03426631|BG000|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
11328306|NCT03426631|FG000|Participant Flow|Placebo First, DAW1033B2 Second|Placebo-matching DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033B2 administered 30 mins before normal sleep time on second study night.
11328307|NCT03426631|FG001|Participant Flow|DAW1033B2 First, Placebo Second|DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
11328308|NCT03426631|OG000|Outcome|Placebo|"Placebo before sleep~Placebo oral capsule: Placebo capsule 30 minutes before sleep"
11328309|NCT03426631|OG001|Outcome|DAW1033B2 Oral Capsule|"DAW1033B2 before sleep~DAW1033B2 oral capsule: DAW1033B2 capsule 30 minutes before sleep"
11328310|NCT03426631|EG000|Reported Event|Placebo|"Placebo before sleep~Placebo oral capsule: Placebo capsule 30 minutes before sleep"
11328311|NCT03426631|EG001|Reported Event|DAW1033B2 Oral Capsule|"DAW1033B2 before sleep~DAW1033B2 oral capsule: DAW1033B2 capsule 30 minutes before sleep"
11328312|NCT03426787|BG000|Baseline|Decision Support Tool|"A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.~Decision Aid: Participants will have the option to view a web or paper-based version of the decision aid."
11328313|NCT03426787|FG000|Participant Flow|Project HELP Decision Aid|A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness. Participants will have the option to view a web or paper-based version of the decision aid.
11328314|NCT03426787|OG000|Outcome|Knowledge Pre-Test Scores|Participants knowledge scores at the baseline level.
11328315|NCT03426787|OG001|Outcome|Knowledge Post Test Scores|Participants knowledge scores after using intervention
11328316|NCT03426787|OG000|Outcome|Decisional Conflict Pre-Test Scores|Participants knowledge scores at the baseline level.
11328317|NCT03426787|OG001|Outcome|Decisional Conflict Post Test Scores|Participants knowledge scores after using intervention
11328318|NCT03426787|OG000|Outcome|Decision Self Efficacy Pre-Test Scores|Participants decision self-efficacy scores at the baseline level.
11328319|NCT03426787|OG001|Outcome|Decision Self Efficacy Post Test Scores|Participants decision self-efficacy scores after using intervention
11328320|NCT03426787|OG000|Outcome|Project HELP Decision Aid|"A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.~Participants will have the option to view a web or paper-based version of the decision aid."
11328321|NCT03426787|EG000|Reported Event|Project HELP Decision Aid|"A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.~Participants will have the option to view a web or paper-based version of the decision aid."
11328322|NCT03426995|BG000|Baseline|Part A: Cohort 1- Sequence PCEP|Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328323|NCT03426995|BG001|Baseline|Part A: Cohort 1- Sequence PCER|Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328324|NCT03426995|BG002|Baseline|Part A: Cohort 1- Sequence APEP|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328325|NCT03426995|BG003|Baseline|Part A: Cohort 1- Sequence APER|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328326|NCT03426995|BG004|Baseline|Part A: Cohort 1- Sequence ACPP|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11336144|NCT03562117|OG002|Outcome|Participants With Severe Hepatic Impairment|Participants with severe hepatic function having Child-Pugh score of 10 to 15 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336145|NCT03562117|EG000|Reported Event|Participants With Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11328327|NCT03426995|BG005|Baseline|Part A: Cohort 1- Sequence ACPR|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328328|NCT03426995|BG006|Baseline|Part A: Cohort 2- Sequence PDFP|Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328329|NCT03426995|BG007|Baseline|Part A: Cohort 2- Sequence PDFR|Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328330|NCT03426995|BG008|Baseline|Part A: Cohort 2- Sequence BPFP|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328331|NCT03426995|BG009|Baseline|Part A: Cohort 2- Sequence BPFR|Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328332|NCT03426995|BG010|Baseline|Part A: Cohort 2- Sequence BDPP|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328333|NCT03426995|BG011|Baseline|Part A: Cohort 2- Sequence BDPR|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328334|NCT03426995|BG012|Baseline|Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328335|NCT03426995|BG013|Baseline|Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328336|NCT03426995|BG014|Baseline|Part C: Cohort 4 and 5- Placebo RD|Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328337|NCT03426995|BG015|Baseline|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328338|NCT03426995|BG016|Baseline|Part C: Cohort 6- GSK3358699 or Placebo RD|Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328339|NCT03426995|BG017|Baseline|Part C: Cohort 7- GSK3358699 or Placebo RD|Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328340|NCT03426995|BG018|Baseline|Part C: Cohort 8- GSK3358699 or Placebo RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
11328341|NCT03426995|BG019|Baseline|Total|Total of all reporting groups
11328342|NCT03426995|FG000|Participant Flow|Part A: Cohort 1- Sequence PCEP|Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328343|NCT03426995|FG001|Participant Flow|Part A: Cohort 1- Sequence PCER|Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328344|NCT03426995|FG002|Participant Flow|Part A: Cohort 1- Sequence APEP|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328345|NCT03426995|FG003|Participant Flow|Part A: Cohort 1- Sequence APER|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328346|NCT03426995|FG004|Participant Flow|Part A: Cohort 1- Sequence ACPP|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328347|NCT03426995|FG005|Participant Flow|Part A: Cohort 1- Sequence ACPR|Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328348|NCT03426995|FG006|Participant Flow|Part A: Cohort 2- Sequence PDFP|Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
10830935|NCT00129441|OG001|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
10830936|NCT00129441|EG000|Reported Event|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
10830937|NCT00129441|EG001|Reported Event|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
10842674|NCT00248794|OG000|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
10830938|NCT00129467|BG000|Baseline|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
10830939|NCT00129467|BG001|Baseline|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
10830940|NCT00129467|BG002|Baseline|Total|Total of all reporting groups
10830941|NCT00129467|FG000|Participant Flow|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
10830942|NCT00129467|FG001|Participant Flow|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
10830943|NCT00129467|OG000|Outcome|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
10830944|NCT00129467|OG001|Outcome|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
10830945|NCT00129467|EG000|Reported Event|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
10830946|NCT00129467|EG001|Reported Event|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
10830947|NCT00129480|BG000|Baseline|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
10830948|NCT00129480|BG001|Baseline|Treatment as Usual|Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services
10830949|NCT00129480|BG002|Baseline|Total|Total of all reporting groups
10830950|NCT00129480|FG000|Participant Flow|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
10830951|NCT00129480|FG001|Participant Flow|Treatment as Usual|Pain treatment as usual
10830952|NCT00129480|OG000|Outcome|Assistance With Pain Treatment (Intervention)|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
10830953|NCT00129480|OG001|Outcome|Treatment as Usual|Pain treatment as usual
10830954|NCT00129480|EG000|Reported Event|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
10830955|NCT00129480|EG001|Reported Event|Treatment as Usual|Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
10830956|NCT00129545|BG000|Baseline|WATCHMAN|WATCHMAN Left Atrial Appendage Closure Technology:
10830957|NCT00129545|BG001|Baseline|Warfarin Control|Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
10830958|NCT00129545|BG002|Baseline|Roll-in|Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
10830959|NCT00129545|BG003|Baseline|Total|Total of all reporting groups
10830960|NCT00129545|FG000|Participant Flow|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
10843164|NCT00252499|BG002|Baseline|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
11095348|NCT01557569|EG000|Reported Event|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
11095349|NCT01557569|EG001|Reported Event|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
11095350|NCT01557582|BG000|Baseline|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
11095351|NCT01557582|FG000|Participant Flow|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
11095352|NCT01557582|OG000|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
11095353|NCT01557582|EG000|Reported Event|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
11095354|NCT01557595|BG000|Baseline|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
11095355|NCT01557595|FG000|Participant Flow|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
11095356|NCT01557595|OG000|Outcome|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
11095357|NCT01557595|EG000|Reported Event|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
11095358|NCT01557699|BG000|Baseline|PMV Puffhaler®|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
11095359|NCT01557699|BG001|Baseline|PMV SoloventTM|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
11095360|NCT01557699|BG002|Baseline|Subcutaneous Meales Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
11095361|NCT01557699|BG003|Baseline|Total|Total of all reporting groups
11095362|NCT01557699|FG000|Participant Flow|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
11095363|NCT01557699|FG001|Participant Flow|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
11095364|NCT01557699|FG002|Participant Flow|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
11095365|NCT01557699|OG000|Outcome|PMV Puffhaler®|Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
11095366|NCT01557699|OG001|Outcome|PMV SoloventTM|Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
11095367|NCT01557699|OG002|Outcome|Subcutaneous Meales Vaccine|Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
11095368|NCT01557699|OG000|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
11095369|NCT01557699|OG001|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
11095370|NCT01557699|OG002|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
11095371|NCT01557699|EG000|Reported Event|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.~N=20"
11095372|NCT01557699|EG001|Reported Event|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.~N=20"
11095373|NCT01557699|EG002|Reported Event|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.~N=20"
11095374|NCT01557790|BG000|Baseline|Proton RT|"Subjects receive proton radiation for seminoma~Proton Radiation Therapy"
11095375|NCT01557790|FG000|Participant Flow|Proton RT|"Subjects receive proton radiation for seminoma~Proton Radiation Therapy"
11095376|NCT01557790|OG000|Outcome|Proton RT|"Subjects receive proton radiation for seminoma~Proton Radiation Therapy"
11095377|NCT01557790|EG000|Reported Event|Proton RT|"Subjects receive proton radiation for seminoma~Proton Radiation Therapy"
11095378|NCT01557842|BG000|Baseline|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
11095379|NCT01557842|BG001|Baseline|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
11095380|NCT01557842|BG002|Baseline|Total|Total of all reporting groups
11095381|NCT01557842|FG000|Participant Flow|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
11095382|NCT01557842|FG001|Participant Flow|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
11095383|NCT01557842|OG000|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
11095384|NCT01557842|OG001|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
11095385|NCT01557842|EG000|Reported Event|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
11095386|NCT01557842|EG001|Reported Event|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
11095387|NCT01557868|BG000|Baseline|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
11095388|NCT01557868|BG001|Baseline|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
11095389|NCT01557868|BG002|Baseline|Total|Total of all reporting groups
11095390|NCT01557868|FG000|Participant Flow|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
11095391|NCT01557868|FG001|Participant Flow|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
11095392|NCT01557868|OG000|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
11095393|NCT01557868|OG001|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
11095394|NCT01557868|EG000|Reported Event|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
11095395|NCT01557868|EG001|Reported Event|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
11095396|NCT01557894|BG000|Baseline|Waitlist Control Group|Wait-list control group
11095397|NCT01557894|BG001|Baseline|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
11095398|NCT01557894|BG002|Baseline|Total|Total of all reporting groups
11095399|NCT01557894|FG000|Participant Flow|Waitlist Control Group|"Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.~Starting from week 10 these participants received the active intervention."
11095400|NCT01557894|FG001|Participant Flow|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
11095401|NCT01557894|OG000|Outcome|Waitlist Control Group|Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
11095402|NCT01557894|OG001|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
11095403|NCT01557894|OG000|Outcome|Waitlist Control Group|Wait-list control group
11095404|NCT01557894|EG000|Reported Event|Waitlist Control Group|Wait-list control group
11095405|NCT01557894|EG001|Reported Event|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
11095406|NCT01557920|BG000|Baseline|Crossover Randomized Propofol and Sevoflurane|"The healthy subject will be anesthetized with Propofol and Sevoflurane in a randomized crossover fashion. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Spontaneous swallows were identified, and categorized as physiological or pathological. Physiological swallows were followed by expiratory flow (E or I-E). Pathological swallows were followed by inspiration (I and E-I).~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
11095407|NCT01557920|FG000|Participant Flow|Propofol First, Then Sevoflurane|"The healthy subject will be anesthetized first with Propofol, and secondarily with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
11095408|NCT01557920|FG001|Participant Flow|Sevoflurane First, Then Propofol|"The healthy subject will be anesthetized first with Sevoflurane, and secondarily with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
11095409|NCT01557920|OG000|Outcome|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
11095410|NCT01557920|OG001|Outcome|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
11095411|NCT01557920|OG000|Outcome|Anesthesia With Propofol and Sevoflurane (All Cases)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (across carbon-dioxide (CO2) levels).
11095412|NCT01557920|OG001|Outcome|Wakefulness (All Cases)|Proportion of pathological (inspiratory) swallows during wakefulness (across CO2 levels)
11095413|NCT01557920|OG002|Outcome|Anesthesia With Propofol and Sevoflurane (Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (during baseline CO2).
11095414|NCT01557920|OG003|Outcome|Anesthesia With Propofol and Sevoflurane (CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during anesthesia (with CO2+4 and +8 insufflation).
11095415|NCT01557920|OG004|Outcome|Wakefulness (During Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia (during baseline CO2).
11095416|NCT01557920|OG005|Outcome|Wakefulness (With CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during wakefulness (with CO2+4 and +8 insufflation).
11095417|NCT01557920|OG000|Outcome|Wakefulness|
11095418|NCT01557920|OG001|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|
11095419|NCT01557920|OG002|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|
11095420|NCT01557920|OG003|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|
11095421|NCT01557920|OG004|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|
11095422|NCT01557920|OG000|Outcome|Phasic Genioglossus Activity (Light Anesthesia)|Phasic activity (Peak activity - Tonic activity)
11095423|NCT01557920|OG001|Outcome|Tonic Genioglossus Activity (Light Anesthesia)|Tonic Genioglossus activity (light anesthesia)
11095424|NCT01557920|OG002|Outcome|Phasic Genioglossus Activity (Deep Anesthesia)|Phasic activity (Peak activity - Tonic activity)
11095425|NCT01557920|OG003|Outcome|Tonic Genioglossus Activity (Deep Anesthesia)|Tonic Genioglossus activity (deep anesthesia)
11095426|NCT01557920|OG000|Outcome|Wakefulness|Minute Ventilation (CO2 baseline)
10830961|NCT00129545|FG001|Participant Flow|WATCHMAN|Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
10830962|NCT00129545|FG002|Participant Flow|WARFARIN|Randomized to receive Warfarin control
10830963|NCT00129545|OG000|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
10830964|NCT00129545|OG001|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
10830965|NCT00129545|OG000|Outcome|WATCHMAN|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~Implant of WATCHMAN Left Atrial Appendage Closure Technology"
10830966|NCT00129545|EG000|Reported Event|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
10830967|NCT00129545|EG001|Reported Event|WATCHMAN|Randomized to receive implantation of the WATCHMAN LAA closure Device
10830968|NCT00129545|EG002|Reported Event|WARFARIN|Randomized to receive Warfarin control
10830969|NCT00129623|BG000|Baseline|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830970|NCT00129623|BG001|Baseline|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830971|NCT00129623|BG002|Baseline|Total|Total of all reporting groups
10830972|NCT00129623|FG000|Participant Flow|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830973|NCT00129623|FG001|Participant Flow|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830974|NCT00129623|OG000|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830975|NCT00129623|OG001|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830976|NCT00129623|OG000|Outcome|Placebo|Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
10830977|NCT00129623|OG001|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
10830978|NCT00129623|EG000|Reported Event|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830979|NCT00129623|EG001|Reported Event|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
10830980|NCT00129649|BG000|Baseline|Control Group|This group received usual care and did not receive a telephone reminder
10830981|NCT00129649|BG001|Baseline|Telephone Reminder Group|"This group received a telephone reminder for their clinic appointment~Telephone reminder call"
10830982|NCT00129649|BG002|Baseline|Total|Total of all reporting groups
10830983|NCT00129649|FG000|Participant Flow|Control Group|This group received usual care and did not receive a telephone reminder
10830984|NCT00129649|FG001|Participant Flow|Telephone Reminder Group|"This group received a telephone reminder for their clinic appointment~Telephone reminder call"
10830985|NCT00129649|OG000|Outcome|Control Group|This group received usual care and did not receive a telephone reminder
10830986|NCT00129649|OG001|Outcome|Telephone Reminder Group|"This group received a telephone reminder for their clinic appointment~Telephone reminder call"
10843165|NCT00252499|BG003|Baseline|Total|Total of all reporting groups
10843166|NCT00252499|FG000|Participant Flow|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
10843167|NCT00252499|FG001|Participant Flow|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
10843168|NCT00252499|FG002|Participant Flow|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
10830987|NCT00129649|EG000|Reported Event|Control Group|This group received usual care and did not receive a telephone reminder
10830988|NCT00129649|EG001|Reported Event|Telephone Reminder Group|"This group received a telephone reminder for their clinic appointment~Telephone reminder call"
10830989|NCT00129701|BG000|Baseline|Patients Attending|"Patients recruited to have a telephone consultation and then at the next appointment a face-to-face appointment~Telephone consultation"
10830990|NCT00129701|FG000|Participant Flow|Patients Attending|"Patients recruited to have a telephone consultation and then at the next appointment a face-to-face appointment~Telephone consultation"
10830991|NCT00129701|OG000|Outcome|Telephone Consultation|Participants attended to a Telephone consultation
10830992|NCT00129701|OG001|Outcome|Face-to-face Consultation|Participants attended to a Face-to-face consultation
10830993|NCT00129701|OG000|Outcome|Patients Attending|Patients recruited to have a telephone consultation and then at the next appointment a face-to-face appointment
10830994|NCT00129701|OG000|Outcome|Patients Attending|"Patients recruited to have a telephone consultation and then at the next appointment a face-to-face appointment~Telephone consultation"
10830995|NCT00129701|EG000|Reported Event|Patients Attending|"Patients recruited to have a telephone consultation and then at the next appointment a face-to-face appointment~Telephone consultation"
10830996|NCT00129727|BG000|Baseline|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
10830997|NCT00129727|FG000|Participant Flow|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
10830998|NCT00129727|OG000|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
10830999|NCT00129727|EG000|Reported Event|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
10831000|NCT00129740|BG000|Baseline|Nilotinib|"400 mg orally twice daily~Nilotinib: 400 mg orally twice daily"
10831001|NCT00129740|FG000|Participant Flow|Nilotinib|"400 mg orally twice daily~Nilotinib: 400 mg orally twice daily"
10831002|NCT00129740|OG000|Outcome|Nilotinib|"400 mg orally twice daily~Nilotinib: 400 mg orally twice daily"
10831003|NCT00129740|EG000|Reported Event|Nilotinib|"400 mg orally twice daily~Nilotinib: 400 mg orally twice daily"
10831004|NCT00129766|BG000|Baseline|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831005|NCT00129766|BG001|Baseline|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831006|NCT00129766|BG002|Baseline|Total|Total of all reporting groups
10831007|NCT00129766|FG000|Participant Flow|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831008|NCT00129766|FG001|Participant Flow|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831009|NCT00129766|OG000|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831010|NCT00129766|OG001|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831011|NCT00129766|OG000|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831012|NCT00129766|EG000|Reported Event|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831013|NCT00129766|EG001|Reported Event|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
10831014|NCT00129935|BG000|Baseline|Arm A: EC-T|"Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.~Docetaxel~Epirubicin~Cyclophosphamide"
10831015|NCT00129935|BG001|Baseline|Arm B: ET-X|"Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.~Docetaxel~Capecitabine~Epirubicin"
10831016|NCT00129935|BG002|Baseline|Total|Total of all reporting groups
10831017|NCT00129935|FG000|Participant Flow|Arm A: EC-T|"Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.~Docetaxel~Epirubicin~Cyclophosphamide"
10831018|NCT00129935|FG001|Participant Flow|Arm B: ET-X|"Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.~Docetaxel~Capecitabine~Epirubicin"
10831019|NCT00129935|OG000|Outcome|Arm A: EC-T|"Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.~Docetaxel~Epirubicin~Cyclophosphamide"
10831020|NCT00129935|OG001|Outcome|Arm B: ET-X|"Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.~Docetaxel~Capecitabine~Epirubicin"
10831021|NCT00129935|EG000|Reported Event|Arm A: EC-T|"Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.~Docetaxel~Epirubicin~Cyclophosphamide"
10831022|NCT00129935|EG001|Reported Event|Arm B: ET-X|"Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.~Docetaxel~Capecitabine~Epirubicin"
10843169|NCT00252499|OG000|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
11095427|NCT01557920|OG001|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (during baseline CO2).
11095428|NCT01557920|OG002|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (baseline CO2)
11095429|NCT01557920|OG003|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (CO2 baseline).
11095430|NCT01557920|OG004|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (during baseline CO2).
11095431|NCT01557920|OG000|Outcome|Wakefulness|Duty cycle (CO2 baseline)
11095432|NCT01557920|OG001|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (during baseline CO2).
11095433|NCT01557920|OG002|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (baseline CO2)
11095434|NCT01557920|OG003|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (CO2 baseline).
11095435|NCT01557920|OG004|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (during baseline CO2).
11095436|NCT01557920|OG000|Outcome|Anesthesia With Propofol and Sevoflurane|
11095437|NCT01557920|OG001|Outcome|Wakefulness|
11095438|NCT01557920|EG000|Reported Event|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
11095439|NCT01557920|EG001|Reported Event|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
11095440|NCT01557946|BG000|Baseline|Citalopram 20/40 mg|Citalopram tablet taken once daily.
11095441|NCT01557946|BG001|Baseline|Healthy Control|No citalopram tablet taken.
11095442|NCT01557946|BG002|Baseline|Total|Total of all reporting groups
11095443|NCT01557946|FG000|Participant Flow|Citalopram 20 mg / 40 mg|"Citalopram tablet taken once daily.~Only applicable to MDD participants. Every subject began on 20 mg, and had the option to titrate up to 40 mg."
11095444|NCT01557946|FG001|Participant Flow|Healthy Control|No citalopram tablet taken.
11095445|NCT01557946|OG000|Outcome|Participants With Depression|Participants with depression receiving citalopram
11095446|NCT01557946|EG000|Reported Event|Citalopram 20 mg / 40 mg|Citalopram tablet taken once daily.
11095447|NCT01557946|EG001|Reported Event|Healthy Control|No citalopram tablet taken.
11095448|NCT01557959|BG000|Baseline|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
11095449|NCT01557959|FG000|Participant Flow|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
11095450|NCT01557959|OG000|Outcome|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
11095451|NCT01557959|OG000|Outcome|Low Cyclin D1|
11095452|NCT01557959|OG001|Outcome|High Cyclin D1|
11095453|NCT01557959|EG000|Reported Event|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
11095454|NCT01558063|BG000|Baseline|Ketamine Dose 1|"0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095455|NCT01558063|BG001|Baseline|Ketamine Dose 2|"0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095456|NCT01558063|BG002|Baseline|Ketamine Dose 3|"0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095457|NCT01558063|BG003|Baseline|Ketamine Dose 4|"0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095458|NCT01558063|BG004|Baseline|Ketamine Dose 5|"0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095459|NCT01558063|BG005|Baseline|Saline Solution|"Saline infused over 40 minutes and MRI scan~Saline: Single infusion of saline given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095460|NCT01558063|BG006|Baseline|Total|Total of all reporting groups
11095461|NCT01558063|FG000|Participant Flow|Ketamine Dose 1|"0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095462|NCT01558063|FG001|Participant Flow|Ketamine Dose 2|"0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095463|NCT01558063|FG002|Participant Flow|Ketamine Dose 3|"0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095464|NCT01558063|FG003|Participant Flow|Ketamine Dose 4|"0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095465|NCT01558063|FG004|Participant Flow|Ketamine Dose 5|"0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095466|NCT01558063|FG005|Participant Flow|Saline Solution|"Saline infused over 40 minutes and MRI scan~Saline: Single infusion of saline given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095467|NCT01558063|OG000|Outcome|Ketamine Dose 1|"0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095468|NCT01558063|OG001|Outcome|Ketamine Dose 2|"0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095469|NCT01558063|OG002|Outcome|Ketamine Dose 3|"0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095470|NCT01558063|OG003|Outcome|Ketamine Dose 4|"0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095471|NCT01558063|OG004|Outcome|Ketamine Dose 5|"0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan~Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095472|NCT01558063|OG005|Outcome|Saline Solution|"Saline infused over 40 minutes and MRI scan~Saline: Single infusion of saline given intravenously over 40 minutes.~Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion."
11095473|NCT01558063|EG000|Reported Event|All Subjects|Includes all subjects receiving either saline or ketamine. Safety data was not collected or analyzed per dose level of ketamine.
11095474|NCT01558089|BG000|Baseline|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
11095475|NCT01558089|FG000|Participant Flow|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
10843170|NCT00252499|OG001|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
10843171|NCT00252499|OG002|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
10843172|NCT00252499|EG000|Reported Event|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
10843173|NCT00252499|EG001|Reported Event|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
10843174|NCT00252499|EG002|Reported Event|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
10843175|NCT00252512|BG000|Baseline|Contingency Management|Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
10843176|NCT00252512|BG001|Baseline|Placebo|Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
10843177|NCT00252512|BG002|Baseline|Total|Total of all reporting groups
10843178|NCT00252512|FG000|Participant Flow|Contingency Management|Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
10843179|NCT00252512|FG001|Participant Flow|Placebo|Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
10843180|NCT00252512|OG000|Outcome|Contingency Management|Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
10843181|NCT00252512|OG001|Outcome|Placebo|Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
10843182|NCT00252512|EG000|Reported Event|Contingency Management|Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
10843183|NCT00252512|EG001|Reported Event|Baseline|Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
10843184|NCT00252538|BG000|Baseline|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
10843185|NCT00252538|FG000|Participant Flow|Group 1 MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
10843186|NCT00252538|FG001|Participant Flow|Group 2 Non MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
10843187|NCT00252538|OG000|Outcome|Group 1- MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
10843188|NCT00252538|OG001|Outcome|Group 2- no MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
10843189|NCT00252538|EG000|Reported Event|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
10843190|NCT00252564|BG000|Baseline|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via T connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
10843191|NCT00252564|BG001|Baseline|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
10843192|NCT00252564|BG002|Baseline|Total|Total of all reporting groups
11095476|NCT01558089|OG000|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
10842675|NCT00248794|OG001|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
10842676|NCT00248794|OG002|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
10842677|NCT00248794|OG000|Outcome|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
11095477|NCT01558089|EG000|Reported Event|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
11095478|NCT01558128|BG000|Baseline|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
11095479|NCT01558128|FG000|Participant Flow|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
11095480|NCT01558128|OG000|Outcome|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
11095481|NCT01558128|EG000|Reported Event|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
11095482|NCT01558271|BG000|Baseline|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095483|NCT01558271|BG001|Baseline|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095484|NCT01558271|BG002|Baseline|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
11095485|NCT01558271|BG003|Baseline|Total|Total of all reporting groups
11095486|NCT01558271|FG000|Participant Flow|LY2189265|Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095487|NCT01558271|FG001|Participant Flow|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095488|NCT01558271|FG002|Participant Flow|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
11095489|NCT01558271|OG000|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy.
11095490|NCT01558271|OG001|Outcome|Placebo|Once-weekly SC injection of placebo for 26 weeks of blinded therapy.
11095491|NCT01558271|OG002|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 24 weeks of open therapy.
11095492|NCT01558271|OG000|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095493|NCT01558271|OG001|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095494|NCT01558271|OG002|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
11095495|NCT01558271|OG002|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
11095496|NCT01558271|EG000|Reported Event|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095497|NCT01558271|EG001|Reported Event|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
11095498|NCT01558271|EG002|Reported Event|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
11095499|NCT01558297|BG000|Baseline|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
11095500|NCT01558297|BG001|Baseline|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
11095501|NCT01558297|BG002|Baseline|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
11095502|NCT01558297|BG003|Baseline|Total|Total of all reporting groups
10842678|NCT00248794|OG001|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
10842679|NCT00248794|OG002|Outcome|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
10842680|NCT00248794|OG000|Outcome|CRT + Skills Training|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
10842681|NCT00248794|OG001|Outcome|ICBCR and Skills Training|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
10842682|NCT00248794|OG002|Outcome|Skills Group Control|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
10842683|NCT00248794|EG000|Reported Event|CRT+Skills Group|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
10842684|NCT00248794|EG001|Reported Event|ICBCR + Skills Group|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
10842685|NCT00248794|EG002|Reported Event|Skills Group + Generic Contact|Life skills group + up to five individual contacts with research staff without active cognitive training
10842686|NCT00248807|BG000|Baseline|Subjects With Spinal Cord Injury|Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
10842687|NCT00248807|BG001|Baseline|Non-spinal Cord Injured Subjects|Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
10842688|NCT00248807|BG002|Baseline|Total|Total of all reporting groups
10842689|NCT00248807|FG000|Participant Flow|Subjects With Spinal Cord Injury (SCI)|Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
10842690|NCT00248807|FG001|Participant Flow|Subjects Without SCI (Non-SCI)|Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
10842691|NCT00248807|OG000|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
10842692|NCT00248807|OG001|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
10842693|NCT00248807|OG002|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
10842694|NCT00248807|OG003|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
10842695|NCT00248807|OG000|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug.
10842696|NCT00248807|OG001|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug.
10842697|NCT00248807|EG000|Reported Event|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
10842698|NCT00248807|EG001|Reported Event|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
10842699|NCT00248807|EG002|Reported Event|ARM 3|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
10842700|NCT00248807|EG003|Reported Event|ARM 4|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
10842701|NCT00248833|BG000|Baseline|1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842702|NCT00248833|BG001|Baseline|2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842703|NCT00248833|BG002|Baseline|3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842704|NCT00248833|BG003|Baseline|Total|Total of all reporting groups
10843193|NCT00252564|FG000|Participant Flow|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via T connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
11095503|NCT01558297|FG000|Participant Flow|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
10831023|NCT00129961|BG000|Baseline|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
10831024|NCT00129961|BG001|Baseline|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
10831025|NCT00129961|BG002|Baseline|Total|Total of all reporting groups
10831026|NCT00129961|FG000|Participant Flow|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
10831027|NCT00129961|FG001|Participant Flow|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
10831028|NCT00129961|OG000|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
10831029|NCT00129961|OG001|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
10831030|NCT00129961|EG000|Reported Event|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
11095504|NCT01558297|FG001|Participant Flow|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
10843194|NCT00252564|FG001|Participant Flow|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
10843195|NCT00252564|OG000|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via T connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
10843196|NCT00252564|OG001|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
10843197|NCT00252564|EG000|Reported Event|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via T connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
10843198|NCT00252564|EG001|Reported Event|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
10843199|NCT00252577|BG000|Baseline|Bipolar Disorder|"Veterans with bipolar disorder~Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years"
10843200|NCT00252577|FG000|Participant Flow|Bipolar Disorder|"Veterans with bipolar disorder~Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years"
10843201|NCT00252577|OG000|Outcome|Bipolar Disorder|"Veterans with bipolar disorder~Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years"
10843202|NCT00252577|EG000|Reported Event|Bipolar Disorder|Subjects with Bipolar Disorder who are treated with lithium
10843203|NCT00252590|BG000|Baseline|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
10843204|NCT00252590|BG001|Baseline|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
10843205|NCT00252590|BG002|Baseline|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
10843206|NCT00252590|BG003|Baseline|Total|Total of all reporting groups
10843207|NCT00252590|FG000|Participant Flow|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing."
10843208|NCT00252590|FG001|Participant Flow|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health."
10843209|NCT00252590|FG002|Participant Flow|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
10843210|NCT00252590|OG000|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
10843211|NCT00252590|OG001|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
10843212|NCT00252590|OG002|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
10843213|NCT00252590|EG000|Reported Event|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
10843214|NCT00252590|EG001|Reported Event|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
10843215|NCT00252590|EG002|Reported Event|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
10843216|NCT00252629|BG000|Baseline|Therapeutic Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
10843217|NCT00252629|BG001|Baseline|Sham Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
10843218|NCT00252629|BG002|Baseline|Healthy Asymptomatic Control|"Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.~They all score below the clinical thershold and assigned as healthy asymptomatic"
10843219|NCT00252629|BG003|Baseline|Total|Total of all reporting groups
10843220|NCT00252629|FG000|Participant Flow|Therapeutic Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on therapeutic nasal CPAP."
11095505|NCT01558297|FG002|Participant Flow|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
11095506|NCT01558297|OG000|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
11095507|NCT01558297|OG001|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
11095508|NCT01558297|OG002|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
11095509|NCT01558297|EG000|Reported Event|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
11095510|NCT01558297|EG001|Reported Event|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
11095511|NCT01558297|EG002|Reported Event|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
11095512|NCT01558596|BG000|Baseline|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
11095513|NCT01558596|BG001|Baseline|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
11095514|NCT01558596|BG002|Baseline|Total|Total of all reporting groups
11095515|NCT01558596|FG000|Participant Flow|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
11095516|NCT01558596|FG001|Participant Flow|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
11095517|NCT01558596|OG000|Outcome|Sham|Blood pressure cuff inflated to 40-50 mmHg over brachial artery
11095518|NCT01558596|OG001|Outcome|RIPC|Blood pressure cuff inflated to 200 mmHg over the brachial artery while confirming absence of radial and ulnar pulse. Total duration of protocol was 30 minutes, equally divided between reperfusion and ischemia.
11095519|NCT01558596|EG000|Reported Event|Sham|Blood pressure cuff inflated to 40 mmHg to mask controls
11095520|NCT01558596|EG001|Reported Event|RIPC|Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3)
11095521|NCT01558635|BG000|Baseline|Cardioblate CryoFlex Surgical Ablation|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095522|NCT01558635|FG000|Participant Flow|Cardioblate CryoFlex Surgical Ablation|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095523|NCT01558635|OG000|Outcome|Cardioblate CryoFlex Surgical Ablation|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095524|NCT01558635|OG000|Outcome|Cardioblate CryoFlex Surgical Ablation|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095525|NCT01558635|OG000|Outcome|AF Burden in Treated Subjects After 3 Months Follow-Up|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11336146|NCT03562117|EG001|Reported Event|Participants With Moderate Hepatic Impairment|Participants with moderate hepatic function having Child-Pugh score of 7 to 9 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11336147|NCT03562117|EG002|Reported Event|Participants With Severe Hepatic Impairment|Participants with severe hepatic function having Child-Pugh score of 10 to 15 received a single oral dose of gepotidacin 1500 mg administered as 2 × 750 mg tablets on Day 1.
11095526|NCT01558635|OG001|Outcome|AF Burden in Treated Subjects After 6 Months Follow-Up|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095527|NCT01558635|OG002|Outcome|AF Burden in Treated Subjects After 12 Months Follow-Up|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095528|NCT01558635|OG000|Outcome|Quality of Life of Treated Subjects at Baseline|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095529|NCT01558635|OG001|Outcome|Quality of Life of Treated Subjects at 6 Months Follow-Up|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095530|NCT01558635|OG002|Outcome|Quality of Life of Treated Subjects at 12 Months Follow-Up|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095531|NCT01558635|EG000|Reported Event|Cardioblate CryoFlex Surgical Ablation Group With 12 Months of|"Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery~Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted."
11095532|NCT01558661|BG000|Baseline|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
11095533|NCT01558661|FG000|Participant Flow|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
11095534|NCT01558661|OG000|Outcome|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
11095535|NCT01558661|EG000|Reported Event|AG-013736 (AXITINIB)|This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
11095536|NCT01558674|BG000|Baseline|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
11095537|NCT01558674|BG001|Baseline|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
11095538|NCT01558674|BG002|Baseline|Total|Total of all reporting groups
11095539|NCT01558674|FG000|Participant Flow|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
11095540|NCT01558674|FG001|Participant Flow|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
11336148|NCT03562377|BG000|Baseline|Tralokinumab|Participants received tralokinumab every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
11095541|NCT01558674|OG000|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
11095542|NCT01558674|OG001|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
11095543|NCT01558674|OG002|Outcome|MK-7145 16 mg (Part 1: Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
11095544|NCT01558674|OG000|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
11095545|NCT01558674|OG001|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
11095546|NCT01558674|OG002|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
11095547|NCT01558674|OG003|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
11095548|NCT01558674|OG002|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
11095549|NCT01558674|OG001|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
11095550|NCT01558674|OG001|Outcome|MK-7145 10 mg (Part 2:Period 2)|10 mg of MK-7145 once daily for 14 days
10842705|NCT00248833|FG000|Participant Flow|1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842706|NCT00248833|FG001|Participant Flow|2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842707|NCT00248833|FG002|Participant Flow|3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842708|NCT00248833|OG000|Outcome|1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842709|NCT00248833|OG001|Outcome|2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842710|NCT00248833|OG002|Outcome|3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842711|NCT00248833|OG000|Outcome|25ug Group B Meningococcal 44/76 MOS NOMV 5D|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with and without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842712|NCT00248833|OG001|Outcome|50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842713|NCT00248833|EG000|Reported Event|1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842714|NCT00248833|EG001|Reported Event|2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant|"Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842715|NCT00248833|EG002|Reported Event|3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant|"Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.~50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks."
10842716|NCT00249002|BG000|Baseline|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
10842717|NCT00249002|FG000|Participant Flow|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
10842718|NCT00249002|OG000|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
10842719|NCT00249002|EG000|Reported Event|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
10842720|NCT00249249|BG000|Baseline|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
10842721|NCT00249249|BG001|Baseline|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
10842722|NCT00249249|BG002|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
10842723|NCT00249249|BG003|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
10842724|NCT00249249|BG004|Baseline|Total|Total of all reporting groups
10842725|NCT00249249|FG000|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
10842726|NCT00249249|FG001|Participant Flow|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
10842727|NCT00249249|FG002|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
10842728|NCT00249249|FG003|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
10842729|NCT00249249|OG000|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
10842730|NCT00249249|OG001|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
10842731|NCT00249249|OG002|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
11095551|NCT01558674|OG000|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
11095552|NCT01558674|OG001|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
11095553|NCT01558674|OG002|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
11095554|NCT01558674|OG001|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
11095555|NCT01558674|EG000|Reported Event|MK-7145 8 mg (Part 1:Period 1)|Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
11095556|NCT01558674|EG001|Reported Event|Furosemide 40 mg (Part 1:Period 2)|Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
11095557|NCT01558674|EG002|Reported Event|Post Trial|Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
11095558|NCT01558700|BG000|Baseline|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
11095559|NCT01558700|BG001|Baseline|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
11095560|NCT01558700|BG002|Baseline|Total|Total of all reporting groups
11095561|NCT01558700|FG000|Participant Flow|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
11095562|NCT01558700|FG001|Participant Flow|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
11095563|NCT01558700|OG000|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
11095564|NCT01558700|OG001|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
11095565|NCT01558700|EG000|Reported Event|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
11095566|NCT01558700|EG001|Reported Event|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
11095567|NCT01558739|BG000|Baseline|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
11095568|NCT01558739|FG000|Participant Flow|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
11095569|NCT01558739|OG000|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
11095570|NCT01558739|EG000|Reported Event|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
11095571|NCT01558752|BG000|Baseline|Corail|"Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.~Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion)."
11095572|NCT01558752|BG001|Baseline|Tri-Lock|"Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).~Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert)."
11095573|NCT01558752|BG002|Baseline|Total|Total of all reporting groups
11095574|NCT01558752|FG000|Participant Flow|Corail|"Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.~Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion)."
11095575|NCT01558752|FG001|Participant Flow|Tri-Lock|"Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).~Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert)."
11095576|NCT01558752|OG000|Outcome|Corail|"Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.~Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion)."
11095577|NCT01558752|OG001|Outcome|Tri-Lock|"Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).~Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert)."
11095578|NCT01558752|EG000|Reported Event|Corail|"Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.~Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion)."
11095579|NCT01558752|EG001|Reported Event|Tri-Lock|"Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).~Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert)."
10842732|NCT00249249|OG003|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
10842733|NCT00249249|EG000|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
10842734|NCT00249249|EG001|Reported Event|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
10842735|NCT00249249|EG002|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
10842736|NCT00249249|EG003|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
10842737|NCT00249288|BG000|Baseline|Placebo|Participants received 2 mg/daily of placebo, for 12 weeks
10842738|NCT00249288|BG001|Baseline|Folate|Patients underwent a 12 week trial of folate 2 mg/d
10842739|NCT00249288|BG002|Baseline|Total|Total of all reporting groups
10842740|NCT00249288|FG000|Participant Flow|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
10842741|NCT00249288|FG001|Participant Flow|Placebo|
10842742|NCT00249288|OG000|Outcome|Current Smoker|Study participants with current smoker status
10842743|NCT00249288|OG001|Outcome|Past Smoker|Participants with past smoker status
10842744|NCT00249288|OG002|Outcome|Never Smoker|Participants with never smoker status
10842745|NCT00249288|OG000|Outcome|CC Genotype|Study participants with MTHFR genotype CC
10842746|NCT00249288|OG001|Outcome|T- Genotype|Participants with MTHFR genotype T (T allele carrier)
10842747|NCT00249288|OG000|Outcome|Overall|All study participants at baseline
10842748|NCT00249288|OG000|Outcome|Folate|"Participants will receive a 2 mg/ day dose of folate, for 12 weeks~Folate: Folic acid taken as 2, 1mg capsule daily for 12 weeks"
10842749|NCT00249288|OG001|Outcome|Placebo|"Participants will receive a 2 mg/ day dose of placebo, for 12 weeks~Placebo: Placebo taken by mouth daily as 2, 1mg capsule daily for 12 weeks"
11095580|NCT01558791|BG000|Baseline|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
11095581|NCT01558791|BG001|Baseline|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
11095582|NCT01558791|BG002|Baseline|Total|Total of all reporting groups
11095583|NCT01558791|FG000|Participant Flow|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
11095584|NCT01558791|FG001|Participant Flow|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
11095585|NCT01558791|OG000|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
11095586|NCT01558791|OG001|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
11095587|NCT01558791|OG000|Outcome|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
11095588|NCT01558791|OG001|Outcome|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
11095589|NCT01558791|EG000|Reported Event|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
11095590|NCT01558791|EG001|Reported Event|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
11095591|NCT01559012|BG000|Baseline|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095592|NCT01559012|BG001|Baseline|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095593|NCT01559012|BG002|Baseline|Total|Total of all reporting groups
11095594|NCT01559012|FG000|Participant Flow|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095595|NCT01559012|FG001|Participant Flow|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095596|NCT01559012|OG000|Outcome|Clonidine|"Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized.~Every patient is the comparison as to herself"
11095597|NCT01559012|OG001|Outcome|Placebo|"Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized~Every patient is the comparison as to herself"
11095598|NCT01559012|OG000|Outcome|Clonidine|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095599|NCT01559012|OG001|Outcome|Placebo|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095600|NCT01559012|OG000|Outcome|Clonidine|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
11095601|NCT01559012|OG001|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
11095602|NCT01559012|OG000|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
11095603|NCT01559012|OG001|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
11095604|NCT01559012|OG000|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.
11095605|NCT01559012|OG001|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
11095606|NCT01559012|OG000|Outcome|Mean Birth Weight of 12 Patients|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
11336149|NCT03562377|BG001|Baseline|Placebo|Participants received placebo every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
11336150|NCT03562377|BG002|Baseline|Total|Total of all reporting groups
11336151|NCT03562377|FG000|Participant Flow|Tralokinumab|Participants received tralokinumab every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
11095607|NCT01559012|OG000|Outcome|APGAR Score at 1'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
11095608|NCT01559012|OG001|Outcome|APGAR Score at 5'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
10842750|NCT00249288|OG000|Outcome|Deficit Syndrome|Study participants with deficit syndrome
10842751|NCT00249288|OG001|Outcome|Not Deficit Syndrome|Participants without deficit syndrome
10842752|NCT00249288|EG000|Reported Event|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
10842753|NCT00249288|EG001|Reported Event|Placebo|Participants receiving 2mg/daily of placebo, for 12 weeks
10842754|NCT00249379|BG000|Baseline|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
10842755|NCT00249379|BG001|Baseline|Control|No specific intervention, monitored for outcomes
10842756|NCT00249379|BG002|Baseline|Total|Total of all reporting groups
10842757|NCT00249379|FG000|Participant Flow|Acamprosate|Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period
10842758|NCT00249379|FG001|Participant Flow|Control|No specific intervention, received standard Drug Court counseling, monitored for outcomes
10842759|NCT00249379|OG000|Outcome|Acamprosate|participants taking study medication
10842760|NCT00249379|OG001|Outcome|Control|
10842761|NCT00249379|EG000|Reported Event|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
10842762|NCT00249379|EG001|Reported Event|Control|No specific intervention, monitored for outcomes
10842763|NCT00249444|BG000|Baseline|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
10842764|NCT00249444|BG001|Baseline|Placebo|"placebo~Placebo: placebo"
10842765|NCT00249444|BG002|Baseline|Total|Total of all reporting groups
10842766|NCT00249444|FG000|Participant Flow|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
10842767|NCT00249444|FG001|Participant Flow|Placebo|"placebo~Placebo: placebo"
10842768|NCT00249444|OG000|Outcome|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
10842769|NCT00249444|OG001|Outcome|Placebo|"placebo~Placebo: placebo"
10842770|NCT00249444|EG000|Reported Event|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
10842771|NCT00249444|EG001|Reported Event|Placebo|"placebo~Placebo: placebo"
10842772|NCT00249470|BG000|Baseline|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
10842773|NCT00249470|BG001|Baseline|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
10842774|NCT00249470|BG002|Baseline|Total|Total of all reporting groups
10842775|NCT00249470|FG000|Participant Flow|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
10842776|NCT00249470|FG001|Participant Flow|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
10842777|NCT00249470|OG000|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
10842778|NCT00249470|OG001|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
11095609|NCT01559012|OG000|Outcome|Clonidine|systolic blood pressure was recorded during clonidine treatment cycle
11095610|NCT01559012|OG001|Outcome|Placebo|systolic blood pressure was recorded during placebo cycle
11095611|NCT01559012|OG000|Outcome|Clonidine|diastolic blood pressure was recorded every day during clonidine treatment cycle
10831031|NCT00129961|EG001|Reported Event|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
10831032|NCT00129987|BG000|Baseline|Nurse Group|Consultation of asthma patients by nurse
10831033|NCT00129987|BG001|Baseline|Lay Educator Group|Consultation of asthma patients by lay educator
10831034|NCT00129987|BG002|Baseline|Total|Total of all reporting groups
10831035|NCT00129987|FG000|Participant Flow|Nurse Group|Consultation of asthma patients by nurse
10831036|NCT00129987|FG001|Participant Flow|Lay Educator Group|Consultation of asthma patients by lay educator
10831037|NCT00129987|OG000|Outcome|Nurse Group|Consultation of asthma patients by nurse
10831038|NCT00129987|OG001|Outcome|Lay Educator Group|Consultation of asthma patients by lay educator
10831039|NCT00129987|EG000|Reported Event|Nurse Group|Consultation of asthma patients by nurse
10831040|NCT00129987|EG001|Reported Event|Lay Educator Group|Consultation of asthma patients by lay educator
10831041|NCT00130039|BG000|Baseline|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
10831042|NCT00130039|BG001|Baseline|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
10831043|NCT00130039|BG002|Baseline|Total|Total of all reporting groups
10831044|NCT00130039|FG000|Participant Flow|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
10831045|NCT00130039|FG001|Participant Flow|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
10831046|NCT00130039|OG000|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
10831047|NCT00130039|OG001|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
10831048|NCT00130039|EG000|Reported Event|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
10831049|NCT00130039|EG001|Reported Event|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
10831050|NCT00130117|BG000|Baseline|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
10831051|NCT00130117|BG001|Baseline|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
10831052|NCT00130117|BG002|Baseline|Total|Total of all reporting groups
10831053|NCT00130117|FG000|Participant Flow|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
10831054|NCT00130117|FG001|Participant Flow|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
10831055|NCT00130117|OG000|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
10831056|NCT00130117|OG001|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
10831057|NCT00130117|OG001|Outcome|Oral Contraceptive Pills (OCPs)|"PLACEBO~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
10831058|NCT00130117|EG000|Reported Event|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
10831059|NCT00130117|EG001|Reported Event|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
10831060|NCT00130208|BG000|Baseline|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
10831061|NCT00130208|BG001|Baseline|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
10831062|NCT00130208|BG002|Baseline|Total|Total of all reporting groups
10831063|NCT00130208|FG000|Participant Flow|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
10831064|NCT00130208|FG001|Participant Flow|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
10831065|NCT00130208|OG000|Outcome|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
10831066|NCT00130208|OG001|Outcome|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
10831067|NCT00130208|EG000|Reported Event|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
10831068|NCT00130208|EG001|Reported Event|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
10831069|NCT00130247|BG000|Baseline|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
10831070|NCT00130247|BG001|Baseline|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
10831071|NCT00130247|BG002|Baseline|Total|Total of all reporting groups
10831072|NCT00130247|FG000|Participant Flow|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
10831073|NCT00130247|FG001|Participant Flow|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
10831074|NCT00130247|OG000|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
10831075|NCT00130247|OG001|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
10831076|NCT00130247|EG000|Reported Event|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
10831077|NCT00130247|EG001|Reported Event|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
10831078|NCT00130286|BG000|Baseline|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831079|NCT00130286|BG001|Baseline|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831080|NCT00130286|BG002|Baseline|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831081|NCT00130286|BG003|Baseline|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831082|NCT00130286|BG004|Baseline|Total|Total of all reporting groups
10831083|NCT00130286|FG000|Participant Flow|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831084|NCT00130286|FG001|Participant Flow|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831085|NCT00130286|FG002|Participant Flow|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831086|NCT00130286|FG003|Participant Flow|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831087|NCT00130286|OG000|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831088|NCT00130286|OG001|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831089|NCT00130286|OG002|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831090|NCT00130286|OG003|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831091|NCT00130286|EG000|Reported Event|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831092|NCT00130286|EG001|Reported Event|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831093|NCT00130286|EG002|Reported Event|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831094|NCT00130286|EG003|Reported Event|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
10831095|NCT00130520|BG000|Baseline|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
10831096|NCT00130520|FG000|Participant Flow|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
11095612|NCT01559012|OG001|Outcome|Placebo|diastolic blood pressure was recorded every day during placebo cycle
11095613|NCT01559012|EG000|Reported Event|Clonidine|patients are treated with transdermal clonidine patch 5 mg for 5 days
10831097|NCT00130520|OG000|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
10831098|NCT00130520|EG000|Reported Event|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
10831099|NCT00130533|BG000|Baseline|Xeloda (Capecitabine)|"1000 mgrs/m2 twice a day, tablets, 8 cycles~Capecitabine"
10831100|NCT00130533|BG001|Baseline|Observation|Observation. No intervention.
10831101|NCT00130533|BG002|Baseline|Total|Total of all reporting groups
10831102|NCT00130533|FG000|Participant Flow|Xeloda (Capecitabine)|"1000 mgrs/m2 twice a day, tablets, 8 cycles~Capecitabine"
10831103|NCT00130533|FG001|Participant Flow|Observation|Observation. No intervention.
10831104|NCT00130533|OG000|Outcome|Xeloda (Capecitabine)|"1000 mgrs/m2 twice a day, tablets, 8 cycles~Capecitabine"
10831105|NCT00130533|OG001|Outcome|Observation|Observation. No intervention.
10831106|NCT00130533|EG000|Reported Event|Xeloda (Capecitabine)|"1000 mgrs/m2 twice a day, tablets, 8 cycles~Capecitabine"
10831107|NCT00130533|EG001|Reported Event|Observation|Observation. No intervention.
10831108|NCT00130637|BG000|Baseline|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
10831109|NCT00130637|FG000|Participant Flow|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
10831110|NCT00130637|OG000|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
10831111|NCT00130637|EG000|Reported Event|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
10831112|NCT00130689|BG000|Baseline|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
10831113|NCT00130689|FG000|Participant Flow|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
10831114|NCT00130689|OG000|Outcome|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
10831115|NCT00130689|EG000|Reported Event|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
10831116|NCT00130728|BG000|Baseline|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
10831117|NCT00130728|BG001|Baseline|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
10831118|NCT00130728|BG002|Baseline|Total|Total of all reporting groups
10831119|NCT00130728|FG000|Participant Flow|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
10831120|NCT00130728|FG001|Participant Flow|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
10831121|NCT00130728|OG000|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
10831122|NCT00130728|OG001|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
10831123|NCT00130728|EG000|Reported Event|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
10831124|NCT00130728|EG001|Reported Event|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
10843221|NCT00252629|FG001|Participant Flow|Sham Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on sham nasal CPAP."
11095614|NCT01559012|EG001|Reported Event|Placebo|patients are treated with placebo (sham patch) for 5 days
10831125|NCT00130780|BG000|Baseline|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
10831126|NCT00130780|BG001|Baseline|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
10831127|NCT00130780|BG002|Baseline|Total|Total of all reporting groups
10831128|NCT00130780|FG000|Participant Flow|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
10831129|NCT00130780|FG001|Participant Flow|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
10831130|NCT00130780|OG000|Outcome|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
10831131|NCT00130780|OG001|Outcome|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
10831132|NCT00130780|EG000|Reported Event|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
10831133|NCT00130780|EG001|Reported Event|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
10831134|NCT00130793|BG000|Baseline|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
10831135|NCT00130793|BG001|Baseline|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
10831136|NCT00130793|BG002|Baseline|Total|Total of all reporting groups
10831137|NCT00130793|FG000|Participant Flow|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
10831138|NCT00130793|FG001|Participant Flow|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
10831139|NCT00130793|OG000|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
10831140|NCT00130793|OG001|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
10831141|NCT00130793|OG000|Outcome|ZOSTAVAX™With PGSU|ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
10831142|NCT00130793|EG000|Reported Event|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
10831143|NCT00130793|EG001|Reported Event|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
10831144|NCT00130832|BG000|Baseline|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
10831145|NCT00130832|BG001|Baseline|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
10831146|NCT00130832|BG002|Baseline|Total|Total of all reporting groups
10831147|NCT00130832|FG000|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
10831148|NCT00130832|FG001|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
10831149|NCT00130832|OG000|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
10831150|NCT00130832|OG001|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
10831151|NCT00130832|EG000|Reported Event|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
10831152|NCT00130832|EG001|Reported Event|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
10831153|NCT00130923|BG000|Baseline|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
10831154|NCT00130923|BG001|Baseline|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
10831155|NCT00130923|BG002|Baseline|Total|Total of all reporting groups
10831156|NCT00130923|FG000|Participant Flow|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
10831157|NCT00130923|FG001|Participant Flow|Oral Risperidone Aka Risperdal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
10831158|NCT00130923|OG000|Outcome|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
10831159|NCT00130923|OG001|Outcome|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
10831160|NCT00130923|OG001|Outcome|Oral Risperidone Aka Risperdal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
10831161|NCT00130923|EG000|Reported Event|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
11336152|NCT03562377|FG001|Participant Flow|Placebo|Participants received placebo every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
10831162|NCT00130923|EG001|Reported Event|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
10831163|NCT00131248|BG000|Baseline|All Study Participants|
10831164|NCT00131248|FG000|Participant Flow|Medications, Placebo, Medications (Group 1)|"3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
10831165|NCT00131248|FG001|Participant Flow|Placebo, Medications, Placebo (Group 2)|"received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
10831166|NCT00131248|OG000|Outcome|Medications|
10831167|NCT00131248|OG001|Outcome|Placebo|
10831168|NCT00131248|EG000|Reported Event|Medications|
10831169|NCT00131248|EG001|Reported Event|Placebo|
10831170|NCT00131352|BG000|Baseline|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
10831171|NCT00131352|BG001|Baseline|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
10831172|NCT00131352|BG002|Baseline|Total|Total of all reporting groups
10831173|NCT00131352|FG000|Participant Flow|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
10831174|NCT00131352|FG001|Participant Flow|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
10831175|NCT00131352|OG000|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
10831176|NCT00131352|OG001|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
10831177|NCT00131352|EG000|Reported Event|Synvisc - Initial Treatment Period|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
10831178|NCT00131352|EG001|Reported Event|Saline Control - Initial Treatment Period|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
10831179|NCT00131352|EG002|Reported Event|Synvisc - Repeat Treatment Period|Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
10831180|NCT00131352|EG003|Reported Event|Synvisc (From Saline Control) - Repeat Treatment Period|Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
10831181|NCT00131365|BG000|Baseline|ExAblate MRgFUS|Treatment with the ExAblate 2000 system Version 4.1
10831182|NCT00131365|FG000|Participant Flow|ExAblate MRgFUS|Treatment with the ExAblate 2000 system Version 4.1
10831183|NCT00131365|OG000|Outcome|ExAblate MRgFUS|"Treatment with the ExAblate 2000 system Version 4.1~ExAblate 2000"
10831184|NCT00131365|OG000|Outcome|ExAblate MRgFUS|Treatment with the ExAblate 2000 system Version 4.1
10831185|NCT00131365|EG000|Reported Event|ExAblate MRgFUS|"Treatment with the ExAblate 2000 system Version 4.1~ExAblate 2000"
10831186|NCT00131378|BG000|Baseline|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831187|NCT00131378|BG001|Baseline|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831188|NCT00131378|BG002|Baseline|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831189|NCT00131378|BG003|Baseline|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831190|NCT00131378|BG004|Baseline|Total|Total of all reporting groups
10831191|NCT00131378|FG000|Participant Flow|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831192|NCT00131378|FG001|Participant Flow|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831193|NCT00131378|FG002|Participant Flow|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831194|NCT00131378|FG003|Participant Flow|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831195|NCT00131378|OG000|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831196|NCT00131378|OG001|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831197|NCT00131378|OG002|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831198|NCT00131378|OG003|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831199|NCT00131378|OG000|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831200|NCT00131378|OG001|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831201|NCT00131378|EG000|Reported Event|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831202|NCT00131378|EG001|Reported Event|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831203|NCT00131378|EG002|Reported Event|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
10831204|NCT00131378|EG003|Reported Event|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
10831205|NCT00131456|BG000|Baseline|Placebo|Matched Placebo
10831206|NCT00131456|BG001|Baseline|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
10831207|NCT00131456|BG002|Baseline|Total|Total of all reporting groups
10831208|NCT00131456|FG000|Participant Flow|Placebo|Matched Placebo
10831209|NCT00131456|FG001|Participant Flow|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
10831210|NCT00131456|OG000|Outcome|Placebo|Matched Placebo
10831211|NCT00131456|OG001|Outcome|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
10831212|NCT00131456|EG000|Reported Event|Placebo|Matched Placebo
10831213|NCT00131456|EG001|Reported Event|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
10831214|NCT00131469|BG000|Baseline|Teriparatide (FORTEO)|"Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months~Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily"
10831215|NCT00131469|BG001|Baseline|Placebo|"Daily SQ placebo for 18 months~Placebos"
10831216|NCT00131469|BG002|Baseline|Total|Total of all reporting groups
10831217|NCT00131469|FG000|Participant Flow|Teriparatide (FORTEO)|"Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months~Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily"
10831218|NCT00131469|FG001|Participant Flow|Placebo|"Daily SQ placebo for 18 months~Placebos"
10831219|NCT00131469|OG000|Outcome|Teriparatide (FORTEO)|"Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months~Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily"
10831220|NCT00131469|OG001|Outcome|Placebo|"Daily SQ placebo for 18 months~Placebos"
10831221|NCT00131469|EG000|Reported Event|Teriparatide (FORTEO)|"Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months~Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily"
10831222|NCT00131469|EG001|Reported Event|Placebo|"Daily SQ placebo for 18 months~Placebos"
10831223|NCT00131508|BG000|Baseline|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
10831224|NCT00131508|BG001|Baseline|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
10831225|NCT00131508|BG002|Baseline|Total|Total of all reporting groups
10831226|NCT00131508|FG000|Participant Flow|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
10831227|NCT00131508|FG001|Participant Flow|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
10831228|NCT00131508|OG000|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
10831229|NCT00131508|OG001|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
10831230|NCT00131508|EG000|Reported Event|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
10831231|NCT00131508|EG001|Reported Event|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
10831232|NCT00131573|BG000|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10831233|NCT00131573|BG001|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10831234|NCT00131573|BG002|Baseline|Total|Total of all reporting groups
10831235|NCT00131573|FG000|Participant Flow|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10831236|NCT00131573|FG001|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
10831237|NCT00131573|OG000|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
10831238|NCT00131573|OG001|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10831239|NCT00131573|OG000|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10831240|NCT00131573|EG000|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
10831241|NCT00131573|EG001|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
10831242|NCT00131664|BG000|Baseline|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
10831243|NCT00131664|BG001|Baseline|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
10831244|NCT00131664|BG002|Baseline|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
10831245|NCT00131664|BG003|Baseline|Total|Total of all reporting groups
10831246|NCT00131664|FG000|Participant Flow|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD.
10831247|NCT00131664|FG001|Participant Flow|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID.
10831248|NCT00131664|FG002|Participant Flow|Metformin|Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID.
10831249|NCT00131664|FG003|Participant Flow|Avandia, Amaryl and Metformin|Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months.
10831250|NCT00131664|FG004|Participant Flow|Avandamet and Amaryl|Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months
10831251|NCT00131664|FG005|Participant Flow|Metformin and Amaryl|Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months.
10831252|NCT00131664|OG000|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
10831253|NCT00131664|OG001|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
10831254|NCT00131664|OG002|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
10831255|NCT00131664|OG000|Outcome|Avandia and Amaryl|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
10831256|NCT00131664|OG001|Outcome|Avandamet|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
10831257|NCT00131664|OG002|Outcome|Metformin|: 500 mg twice daily titration up to 1000 mg twice daily over 6 months
10831258|NCT00131664|EG000|Reported Event|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months.
10831259|NCT00131664|EG001|Reported Event|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months
10831260|NCT00131664|EG002|Reported Event|Metformin|Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
10831261|NCT00131677|BG000|Baseline|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
10831262|NCT00131677|BG001|Baseline|Placebo|Placebo arm--received matching placebo
10831263|NCT00131677|BG002|Baseline|Total|Total of all reporting groups
10831264|NCT00131677|FG000|Participant Flow|Tenofovir Disoproxil Fumarate|Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
10831265|NCT00131677|FG001|Participant Flow|Placebo|Participants received matching placebo, to be taken daily.
10831266|NCT00131677|OG000|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily
10831267|NCT00131677|OG001|Outcome|Placebo|Matching placebo daily
10831268|NCT00131677|OG000|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily.
10831269|NCT00131677|OG000|Outcome|Treatment Emergent Cohort|Includes all who entered treatment emergent cohort (active and placebo arms)
10831270|NCT00131677|OG000|Outcome|All Enrolled Participants|
10831271|NCT00131677|OG000|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
10831272|NCT00131677|OG001|Outcome|Placebo|Placebo arm--received matching placebo
11095615|NCT01559064|BG000|Baseline|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095616|NCT01559064|BG001|Baseline|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095617|NCT01559064|BG002|Baseline|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095618|NCT01559064|BG003|Baseline|Total|Total of all reporting groups
11095619|NCT01559064|FG000|Participant Flow|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095620|NCT01559064|FG001|Participant Flow|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095621|NCT01559064|FG002|Participant Flow|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095622|NCT01559064|OG000|Outcome|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095623|NCT01559064|OG001|Outcome|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095624|NCT01559064|OG002|Outcome|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095625|NCT01559064|EG000|Reported Event|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095626|NCT01559064|EG001|Reported Event|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095627|NCT01559064|EG002|Reported Event|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
11095628|NCT01559090|BG000|Baseline|MEDI-546 100 mg IV|Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095629|NCT01559090|BG001|Baseline|MEDI-546 300 mg IV|Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095630|NCT01559090|BG002|Baseline|MEDI-546 1000 mg IV|Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV
11095631|NCT01559090|BG003|Baseline|Total|Total of all reporting groups
11095632|NCT01559090|FG000|Participant Flow|MEDI-546 100 mg IV|Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095633|NCT01559090|FG001|Participant Flow|MEDI-546 300 mg IV|Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095634|NCT01559090|FG002|Participant Flow|MEDI-546 1000 mg IV|Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV
11095635|NCT01559090|OG000|Outcome|MEDI-546 100 mg IV|Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095636|NCT01559090|OG001|Outcome|MEDI-546 300 mg IV|Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095637|NCT01559090|OG002|Outcome|MEDI-546 1000 mg IV|Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV
11095638|NCT01559090|EG000|Reported Event|MEDI-546 100 mg IV|Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
11095639|NCT01559090|EG001|Reported Event|MEDI-546 300 mg IV|Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
10831273|NCT00131677|EG000|Reported Event|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
11095640|NCT01559090|EG002|Reported Event|MEDI-546 1000 mg IV|Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV
11095641|NCT01559116|BG000|Baseline|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
11095642|NCT01559116|FG000|Participant Flow|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
11336153|NCT03562377|OG000|Outcome|Tralokinumab|Participants received tralokinumab every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
11328349|NCT03426995|FG007|Participant Flow|Part A: Cohort 2- Sequence PDFR|Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328350|NCT03426995|FG008|Participant Flow|Part A: Cohort 2- Sequence BPFP|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328351|NCT03426995|FG009|Participant Flow|Part A: Cohort 2- Sequence BPFR|Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328352|NCT03426995|FG010|Participant Flow|Part A: Cohort 2- Sequence BDPP|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328353|NCT03426995|FG011|Participant Flow|Part A: Cohort 2- Sequence BDPR|Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
11328354|NCT03426995|FG012|Participant Flow|Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328355|NCT03426995|FG013|Participant Flow|Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328356|NCT03426995|FG014|Participant Flow|Part C: Cohort 4 and 5- Placebo RD|Participants received once daily repeat dose (RD) of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328357|NCT03426995|FG015|Participant Flow|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328358|NCT03426995|FG016|Participant Flow|Part C: Cohort 6- GSK3358699 or Placebo RD|Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328359|NCT03426995|FG017|Participant Flow|Part C: Cohort 7- GSK3358699 or Placebo RD|Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328360|NCT03426995|FG018|Participant Flow|Part C: Cohort 8- GSK3358699 or Placebo RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
10831274|NCT00131677|EG001|Reported Event|Placebo|Matching placebo daily
11328361|NCT03426995|OG000|Outcome|Part A: Placebo SD|Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
11328362|NCT03426995|OG001|Outcome|Part A: GSK3358699 1 mg SD|Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
11328363|NCT03426995|OG002|Outcome|Part A: GSK3358699 3 mg SD|Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
10831275|NCT00131885|BG000|Baseline|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831276|NCT00131885|BG001|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831277|NCT00131885|BG002|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
10831278|NCT00131885|BG003|Baseline|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831279|NCT00131885|BG004|Baseline|Total|Total of all reporting groups
10831280|NCT00131885|FG000|Participant Flow|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831281|NCT00131885|FG001|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831282|NCT00131885|FG002|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
10831283|NCT00131885|FG003|Participant Flow|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831284|NCT00131885|OG000|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831285|NCT00131885|OG001|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831286|NCT00131885|OG002|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
10831287|NCT00131885|OG003|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831288|NCT00131885|EG000|Reported Event|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831289|NCT00131885|EG001|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831290|NCT00131885|EG002|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
10831291|NCT00131885|EG003|Reported Event|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
10831292|NCT00131911|BG000|Baseline|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831293|NCT00131911|BG001|Baseline|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831294|NCT00131911|BG002|Baseline|Total|Total of all reporting groups
10831295|NCT00131911|FG000|Participant Flow|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831296|NCT00131911|FG001|Participant Flow|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831297|NCT00131911|OG000|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831298|NCT00131911|OG001|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831299|NCT00131911|EG000|Reported Event|All Patients|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
10831300|NCT00131937|BG000|Baseline|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
10831301|NCT00131937|FG000|Participant Flow|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
10831302|NCT00131937|OG000|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
10831303|NCT00131937|EG000|Reported Event|Treatment (Sorafenib)|All patients who received Sorafenib treatment.
10831304|NCT00132002|BG000|Baseline|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
10831305|NCT00132002|FG000|Participant Flow|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
10831306|NCT00132002|OG000|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
10831307|NCT00132002|EG000|Reported Event|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
10831308|NCT00132028|BG000|Baseline|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
10831309|NCT00132028|FG000|Participant Flow|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
10831310|NCT00132028|OG000|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
10831311|NCT00132028|EG000|Reported Event|SAHA (Vorinostat)|
10831312|NCT00132041|BG000|Baseline|All Patients|patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
10831313|NCT00132041|FG000|Participant Flow|All Patients|patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
10831314|NCT00132041|OG000|Outcome|Eligible Patients|patients with cirrhosis undergoing solitary or repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
10831315|NCT00132041|OG000|Outcome|Solitary Ablation|patients with cirrhosis undergoing solitary percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
10831316|NCT00132041|OG001|Outcome|Repetitive Ablation|patients with cirrhosis undergoing repetitive percutaneous radiofrequency ablation (RFA) treatment sessions for the treatment of HCC.
10831317|NCT00132041|OG000|Outcome|Extrahepatic Tumor|In this group, extrahepatic tumors were observed within 18 months of the initial ablation
10831318|NCT00132041|OG001|Outcome|No Extrahepatic Tumors|In this group, no extrahepatic tumors were observed within 18 months of the initial RFA
10831319|NCT00132041|OG000|Outcome|Tumor Free|No evidence of existing tumor was found on pathologic review of the liver at the time of transplant or autopsy within the 18 month observational period
10831320|NCT00132041|OG001|Outcome|Tumor at Pathologic Review|Pathologic review found evidence of existing liver tumor at the time of transplant or autopsy within the 18 month observational period
10831321|NCT00132041|EG000|Reported Event|All Patients|"patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.~radiofrequency ablation"
11095643|NCT01559116|OG000|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT:2 Oral inhalations once daily in the morning for 6 weeks.
10831322|NCT00132132|BG000|Baseline|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
10831323|NCT00132132|BG001|Baseline|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
10831324|NCT00132132|BG002|Baseline|Total|Total of all reporting groups
10831325|NCT00132132|FG000|Participant Flow|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
10831326|NCT00132132|FG001|Participant Flow|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
10831327|NCT00132132|OG000|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
10831328|NCT00132132|OG001|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
10831329|NCT00132132|EG000|Reported Event|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
10831330|NCT00132132|EG001|Reported Event|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
10831331|NCT00132301|BG000|Baseline|Arm 1: Chemotherapy Agent and Prednisone|"Chemotherapy after radical prostatectomy~Docetaxel: Chemotherapy agent~Prednisone: steroid in combination with chemotherapy agent"
10831332|NCT00132301|BG001|Baseline|Arm 2: Standard of Care|Treatment by Standard of care
10831333|NCT00132301|BG002|Baseline|Total|Total of all reporting groups
10831334|NCT00132301|FG000|Participant Flow|Arm 1: Chemotherapy Agent and Prednisone|"Chemotherapy after radical prostatectomy~Docetaxel: Chemotherapy agent~Prednisone: steroid in combination with chemotherapy agent"
10831335|NCT00132301|FG001|Participant Flow|Arm 2: Standard of Care|Treatment by Standard of Care
10831336|NCT00132301|OG000|Outcome|Arm 1: Docetaxel and Prednisone|"Chemotherapy after radical prostatectomy~Docetaxel: Chemotherapy agent~Prednisone: steroid in combination with chemotherapy agent"
10831337|NCT00132301|OG001|Outcome|Arm 2: Standard of Care|Treatment by standard of care
10831338|NCT00132301|EG000|Reported Event|Arm 1: Chemotherapy Agent|"Chemotherapy after radical prostatectomy~Docetaxel: Chemotherapy agent~Prednisone: steroid in combination with chemotherapy agent"
10831339|NCT00132301|EG001|Reported Event|Arm 2: Standard of Care|Treatment by Standard of Care
10831340|NCT00132314|BG000|Baseline|Injectable Risperidone|long-acting injectable risperidone
10831341|NCT00132314|BG001|Baseline|Oral Antipsychotic|oral antipsychotic medication
10831342|NCT00132314|BG002|Baseline|Total|Total of all reporting groups
10831343|NCT00132314|FG000|Participant Flow|Injectable Risperidone|long-acting injectable risperidone
10831344|NCT00132314|FG001|Participant Flow|Oral Antipsychotic|oral antipsychotic medication
10831345|NCT00132314|OG000|Outcome|Injectable Risperidone|long-acting injectable risperidone
10831346|NCT00132314|OG001|Outcome|Oral Antipsychotic|oral antipsychotic medication
10831347|NCT00132314|EG000|Reported Event|Injectable Risperidone|long-acting injectable risperidone
10831348|NCT00132314|EG001|Reported Event|Oral Antipsychotic|oral antipsychotic medication
10831349|NCT00132496|BG000|Baseline|Rabeprazole 10 mg|once daily for 8 weeks
10831350|NCT00132496|BG001|Baseline|Rabeprazole 20 mg|once daily for 8 weeks
10831351|NCT00132496|BG002|Baseline|Total|Total of all reporting groups
10831352|NCT00132496|FG000|Participant Flow|Rabeprazole 10 mg|once daily for 8 weeks
10831353|NCT00132496|FG001|Participant Flow|Rabeprazole 20 mg|once daily for 8 weeks
10831354|NCT00132496|OG000|Outcome|Rabeprazole 10 mg|once daily for 8 weeks
10831355|NCT00132496|OG001|Outcome|Rabeprazole 20 mg|once daily for 8 weeks
10831356|NCT00132496|EG000|Reported Event|Rabeprazole 10 mg|once daily for 8 weeks
10831357|NCT00132496|EG001|Reported Event|Rabeprazole 20 mg|once daily for 8 weeks
10831358|NCT00132678|BG000|Baseline|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
10831359|NCT00132678|BG001|Baseline|Placebo|IM injection every 2 weeks
10831360|NCT00132678|BG002|Baseline|Total|Total of all reporting groups
10831361|NCT00132678|FG000|Participant Flow|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks
10831362|NCT00132678|FG001|Participant Flow|Placebo|intramuscular (IM) injection every 2 weeks
10831363|NCT00132678|FG002|Participant Flow|Open-Label Oral Risperidone|(flexible dosage) 1 to 6 mg/day for the first 3 weeks
10831364|NCT00132678|OG000|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
10831365|NCT00132678|OG001|Outcome|Placebo|IM injection every 2 weeks
10831366|NCT00132678|EG000|Reported Event|RISPERDAL CONSTA|Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
10831367|NCT00132678|EG001|Reported Event|Placebo|Double-blind Period IV. Intramuscular (IM) injection every 2 weeks
10831368|NCT00132678|EG002|Reported Event|Open-Label Oral Risperidone|Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks
10831369|NCT00132678|EG003|Reported Event|Open Label RISPERDAL CONSTA|Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
10831370|NCT00132691|BG000|Baseline|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
10831371|NCT00132691|BG001|Baseline|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
10831372|NCT00132691|BG002|Baseline|Total|Total of all reporting groups
10831373|NCT00132691|FG000|Participant Flow|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
10831374|NCT00132691|FG001|Participant Flow|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
10831375|NCT00132691|OG000|Outcome|Flucinolone Acetonide Implant|A fluocinolone acetonide intravitreal implant (0.59 mg) was surgically placed by a study-certified surgeon was placed in each eligible eye. The first eye was implanted within 28 days of randomization and, if eligible, the second eye within the next 28 days. Prior to implant surgery, topical, periocular or systemic corticosteroids where used as needed to quiet the anterior chamber. Post-implant, systemic corticosteroids and immunosuppressive drugs were tapered and discontinued. If the second eye was not eligible for an implant initially but later became eligible, an implant was placed in the second eye at that time. The treatment algorithm included re-implantation upon reactivation and treatment per best medical judgment for failure to achieve inflammation control, treatment-limiting toxicity and systemic disease requiring systemic therapy.
10831376|NCT00132691|OG001|Outcome|Systemic Therapy|Oral corticosteroids supplemented with immunosuppressive drugs if indicated were given according to published guidelines developed by an expert panel. For participants with active uveitis at baseline, 1 mg/kg/day up to 60 mg/day of prednisone was given until uveitis was controlled or 4 weeks had elapsed. When control was achieved, prednisone was tapered per study guidelines. Immunosuppressive drugs were added when uveitis was not initially controlled with prednisone alone, as corticosteroid-sparing agents when prednisone could not be tapered to 10 mg/day without reactivation of uveitis and for specific uveitis syndromes. Choice of immunosuppressant was made by the study ophthalmologist; immunosuppressant administration and monitoring for toxicity was conducted according to expert guidelines.
10831377|NCT00132691|OG000|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
10831378|NCT00132691|OG001|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
10831379|NCT00132691|OG000|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
10831380|NCT00132691|OG001|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
10831381|NCT00132691|OG000|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy
10831382|NCT00132691|EG000|Reported Event|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
10831383|NCT00132691|EG001|Reported Event|Systemic Therapy|Participants randomized to receive systemic therapy.
10831384|NCT00132730|BG000|Baseline|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831385|NCT00132730|BG001|Baseline|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831386|NCT00132730|BG002|Baseline|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831387|NCT00132730|BG003|Baseline|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
10831388|NCT00132730|BG004|Baseline|Total|Total of all reporting groups
10831389|NCT00132730|FG000|Participant Flow|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
10831390|NCT00132730|FG001|Participant Flow|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
10831391|NCT00132730|FG002|Participant Flow|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831392|NCT00132730|FG003|Participant Flow|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
10831393|NCT00132730|FG004|Participant Flow|MK-0873 2.5 mg + Usual Care|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
11095644|NCT01559116|OG001|Outcome|Olodaterol (5 µg)|"Olodaterol solution for inhalation - RESPIMAT~2 oral inhalations once daily in the morning for 6 weeks."
10831394|NCT00132730|FG005|Participant Flow|Usual Care|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
10831395|NCT00132730|OG000|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831396|NCT00132730|OG001|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831397|NCT00132730|OG002|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831398|NCT00132730|OG003|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
10831399|NCT00132730|EG000|Reported Event|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
10831400|NCT00132730|EG001|Reported Event|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
10831401|NCT00132730|EG002|Reported Event|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831402|NCT00132730|EG003|Reported Event|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
10831403|NCT00132730|EG004|Reported Event|MK-0873 2.5 mg EXT 1|Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
10831404|NCT00132730|EG005|Reported Event|Placebo EXT 1|Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
10831405|NCT00132730|EG006|Reported Event|MK-0873 2.5 mg + Usual Care EXT 2|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
10831406|NCT00132730|EG007|Reported Event|Usual Care EXT2|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
10831407|NCT00132769|BG000|Baseline|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
10831408|NCT00132769|BG001|Baseline|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
11095645|NCT01559116|OG002|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
10831409|NCT00132769|BG002|Baseline|Total|Total of all reporting groups
10831410|NCT00132769|FG000|Participant Flow|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
10831411|NCT00132769|FG001|Participant Flow|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
10831412|NCT00132769|OG000|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
11095646|NCT01559116|OG003|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
10831413|NCT00132769|OG001|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
10831414|NCT00132769|EG000|Reported Event|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
10831415|NCT00132769|EG001|Reported Event|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
10831416|NCT00132808|BG000|Baseline|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
10831417|NCT00132808|BG001|Baseline|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
10831418|NCT00132808|BG002|Baseline|Placebo|Placebo given at randomization and Month 12
10831419|NCT00132808|BG003|Baseline|Total|Total of all reporting groups
10831420|NCT00132808|FG000|Participant Flow|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
10831421|NCT00132808|FG001|Participant Flow|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
10831422|NCT00132808|FG002|Participant Flow|Placebo|Placebo given at randomization and Month 12
10831423|NCT00132808|OG000|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
10831424|NCT00132808|OG001|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
10831425|NCT00132808|OG002|Outcome|Placebo|Placebo given at randomization and Month 12
10831426|NCT00132808|EG000|Reported Event|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
10831427|NCT00132808|EG001|Reported Event|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
10831428|NCT00132808|EG002|Reported Event|Placebo|Placebo given at randomization and Month 12
10831429|NCT00132873|BG000|Baseline|Xyrem (Sodium Oxybate)|
10831430|NCT00132873|FG000|Participant Flow|Xyrem (Sodium Oxybate)|
10831431|NCT00132873|OG000|Outcome|Xyrem (Sodium Oxybate)|
10831432|NCT00132873|EG000|Reported Event|Xyrem (Sodium Oxybate)|
10831433|NCT00132964|BG000|Baseline|Immobilizaton Device|Below Knee walking cast
10831434|NCT00132964|BG001|Baseline|Immobilization Device|Removable ankle brace
10831435|NCT00132964|BG002|Baseline|Total|Total of all reporting groups
10831436|NCT00132964|FG000|Participant Flow|Immobilizaton Device|Below Knee walking cast was placed on the ankle injury.
10831437|NCT00132964|FG001|Participant Flow|Immobilization Device|Removable ankle brace was placed on the injured ankle.
10831438|NCT00132964|OG000|Outcome|Immobilizaton Device|Below Knee walking cast
10831439|NCT00132964|OG001|Outcome|Immobilization Device|Removable ankle brace that you placed on the injured ankle and can be removed as needed by the patient
10831440|NCT00132964|EG000|Reported Event|Immobilizaton Device|Below Knee walking cast
10831441|NCT00132964|EG001|Reported Event|Immobilization Device|Removable ankle brace
10831442|NCT00133575|BG000|Baseline|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831443|NCT00133575|BG001|Baseline|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831444|NCT00133575|BG002|Baseline|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831445|NCT00133575|BG003|Baseline|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831446|NCT00133575|BG004|Baseline|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831447|NCT00133575|BG005|Baseline|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831448|NCT00133575|BG006|Baseline|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
10831449|NCT00133575|BG007|Baseline|Total|Total of all reporting groups
10831450|NCT00133575|FG000|Participant Flow|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831451|NCT00133575|FG001|Participant Flow|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831452|NCT00133575|FG002|Participant Flow|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831453|NCT00133575|FG003|Participant Flow|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831454|NCT00133575|FG004|Participant Flow|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831455|NCT00133575|FG005|Participant Flow|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831456|NCT00133575|FG006|Participant Flow|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
10831457|NCT00133575|OG000|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831458|NCT00133575|OG001|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831459|NCT00133575|OG002|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831460|NCT00133575|OG003|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831461|NCT00133575|OG004|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831462|NCT00133575|OG005|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831463|NCT00133575|OG006|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
10831464|NCT00133575|EG000|Reported Event|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831465|NCT00133575|EG001|Reported Event|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831466|NCT00133575|EG002|Reported Event|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831467|NCT00133575|EG003|Reported Event|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
10831468|NCT00133575|EG004|Reported Event|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
10831469|NCT00133575|EG005|Reported Event|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
10831470|NCT00133575|EG006|Reported Event|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
10831471|NCT00133705|BG000|Baseline|Mifepristone 5 mg.|Twenty-two women received 5 mg. mifepristone daily.
10831472|NCT00133705|BG001|Baseline|Placebo|Twenty women received a placebo pill daily.
10831473|NCT00133705|BG002|Baseline|Total|Total of all reporting groups
10831474|NCT00133705|FG000|Participant Flow|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
10831475|NCT00133705|FG001|Participant Flow|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
10831476|NCT00133705|OG000|Outcome|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
10831477|NCT00133705|OG001|Outcome|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
10831478|NCT00133705|EG000|Reported Event|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
10831479|NCT00133705|EG001|Reported Event|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
10831480|NCT00133809|BG000|Baseline|Islet Transplant|"10 subjects were found eligible and were can be matched to an appropriate donor will receive/have received an islet transplant---1 INELIGIBLE WHILE ON WAITLIST.~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
10831481|NCT00133809|FG000|Participant Flow|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
10831482|NCT00133809|OG000|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
10831483|NCT00133809|EG000|Reported Event|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
10831484|NCT00133952|BG000|Baseline|Placebo|Taken orally daily for up to 48 months
10831485|NCT00133952|BG001|Baseline|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
10831486|NCT00133952|BG002|Baseline|Total|Total of all reporting groups
10831487|NCT00133952|FG000|Participant Flow|Placebo|Taken orally daily for up to 48 months
10831488|NCT00133952|FG001|Participant Flow|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
10831489|NCT00133952|OG000|Outcome|Placebo|Taken orally daily for up to 48 months
10831490|NCT00133952|OG001|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
10831491|NCT00133952|EG000|Reported Event|Placebo|Taken orally daily for up to 48 months
10831492|NCT00133952|EG001|Reported Event|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
10831493|NCT00133978|BG000|Baseline|Glutamine|Glutamine supplementation
10831494|NCT00133978|BG001|Baseline|Antioxidants|Antioxidant supplementation
10831495|NCT00133978|BG002|Baseline|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
10831496|NCT00133978|BG003|Baseline|Placebo|Non-isonitrogenic, iso-caloric placebo solution
10831497|NCT00133978|BG004|Baseline|Total|Total of all reporting groups
10831498|NCT00133978|FG000|Participant Flow|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
10831499|NCT00133978|FG001|Participant Flow|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
10831500|NCT00133978|FG002|Participant Flow|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
10831501|NCT00133978|FG003|Participant Flow|Placebo|Non-isonitrogenic, iso-caloric placebo solution
10831502|NCT00133978|OG000|Outcome|Glutamine|Glutamine supplementation
10831503|NCT00133978|OG001|Outcome|Antioxidants|Antioxidant supplementation
10831504|NCT00133978|OG002|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
10831505|NCT00133978|OG003|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
10831506|NCT00133978|OG000|Outcome|Glutamine|0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
10831507|NCT00133978|OG001|Outcome|No Glutamine|Non-isonitrogenic, iso-caloric placebo solution
10831508|NCT00133978|OG002|Outcome|Antioxidants|500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
10831509|NCT00133978|OG003|Outcome|No Antioxidants|Non-isonitrogenic, iso-caloric placebo solution
10831510|NCT00133978|EG000|Reported Event|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
10831511|NCT00133978|EG001|Reported Event|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
10831512|NCT00133978|EG002|Reported Event|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
10831513|NCT00133978|EG003|Reported Event|Placebo|Non-isonitrogenic, iso-caloric placebo solution
10831514|NCT00133991|BG000|Baseline|R-CVP + HiCy|Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
10831515|NCT00133991|FG000|Participant Flow|R-CVP + HiCy|Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
10831516|NCT00133991|OG000|Outcome|R-CVP + HiCy|Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
10831517|NCT00133991|EG000|Reported Event|R-CVP + HiCy|Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
10831518|NCT00134004|BG000|Baseline|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
10831519|NCT00134004|FG000|Participant Flow|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
10831520|NCT00134004|OG000|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
10831521|NCT00134004|EG000|Reported Event|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
10831522|NCT00134017|BG000|Baseline|Bone Marrow Transplant|Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
10831523|NCT00134017|FG000|Participant Flow|Bone Marrow Transplant|Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
10831524|NCT00134017|OG000|Outcome|Bone Marrow Transplant|Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
10831525|NCT00134017|EG000|Reported Event|Bone Marrow Transplant|Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis
10831526|NCT00134043|BG000|Baseline|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831527|NCT00134043|BG001|Baseline|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831528|NCT00134043|BG002|Baseline|Total|Total of all reporting groups
11095647|NCT01559116|OG004|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
10831529|NCT00134043|FG000|Participant Flow|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831530|NCT00134043|FG001|Participant Flow|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831531|NCT00134043|OG000|Outcome|DTCs (Well-differentiated Thyroid Carcinomas)|Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
10831532|NCT00134043|OG001|Outcome|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831533|NCT00134043|EG000|Reported Event|Arm I & Arm II|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
10831534|NCT00134056|BG000|Baseline|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
10831535|NCT00134056|BG001|Baseline|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
10831536|NCT00134056|BG002|Baseline|Total|Total of all reporting groups
10831537|NCT00134056|FG000|Participant Flow|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
10831538|NCT00134056|FG001|Participant Flow|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
10831539|NCT00134056|OG000|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
10831540|NCT00134056|OG001|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
10831541|NCT00134056|OG000|Outcome|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
10831542|NCT00134056|OG001|Outcome|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
10831543|NCT00134056|OG001|Outcome|Arm II: Atrasentan Hydrochloride|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
10831544|NCT00134056|EG000|Reported Event|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
10831545|NCT00134056|EG001|Reported Event|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
10831546|NCT00134082|BG000|Baseline|Immunotherapy|"All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.~KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.~Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.~Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.~Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0."
10831547|NCT00134082|FG000|Participant Flow|Immunotherapy|"All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.~KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.~Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.~Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.~Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0."
10831548|NCT00134082|OG000|Outcome|Immunotherapy|"All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.~KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.~Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.~Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.~Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0."
10831549|NCT00134082|EG000|Reported Event|Immunotherapy|"All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.~KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.~Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.~Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.~Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0."
10831550|NCT00134381|BG000|Baseline|Bilateral Comparison|In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body.
10831551|NCT00134381|FG000|Participant Flow|EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the left side of the body and placebo to a test site on the right side of the body.
10831552|NCT00134381|FG001|Participant Flow|EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the right side of the body and placebo to a test site on the left side of the body.
10831553|NCT00134381|FG002|Participant Flow|Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.
10831554|NCT00134381|FG003|Participant Flow|Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
10831555|NCT00134381|FG004|Participant Flow|Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.
10831556|NCT00134381|FG005|Participant Flow|Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
10831557|NCT00134381|OG000|Outcome|EGCG in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
10831558|NCT00134381|OG001|Outcome|Placebo (Acetone Vehicle in Subjects Who Received EGCG)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
10831559|NCT00134381|OG002|Outcome|Caffeine in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
10831560|NCT00134381|OG003|Outcome|Placebo (Acetone Vehicle in Subjects Who Received Caffeine)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
11095648|NCT01559116|OG005|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
11095649|NCT01559116|OG000|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
11095650|NCT01559116|OG001|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
11095651|NCT01559116|OG000|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.)
10831561|NCT00134381|OG000|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
10831562|NCT00134381|OG001|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
10831563|NCT00134381|OG002|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
10831564|NCT00134381|OG003|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
10831565|NCT00134381|OG000|Outcome|Caffeine in Vehicle Cream (0.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
10831566|NCT00134381|OG001|Outcome|Placebo Cream (0.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
10831567|NCT00134381|OG002|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
10831568|NCT00134381|OG003|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
10831569|NCT00134381|OG004|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
10831570|NCT00134381|OG005|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
10831571|NCT00134381|EG000|Reported Event|Bilateral Comparison|In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body after exposure of the test sites to UVB.
10831572|NCT00134563|BG000|Baseline|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
10831573|NCT00134563|BG001|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
10831574|NCT00134563|BG002|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
10831575|NCT00134563|BG003|Baseline|Total|Total of all reporting groups
10831576|NCT00134563|FG000|Participant Flow|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
10831577|NCT00134563|FG001|Participant Flow|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
10831578|NCT00134563|FG002|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
11095652|NCT01559116|EG000|Reported Event|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
10831579|NCT00134563|OG000|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
10831580|NCT00134563|OG001|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
10831581|NCT00134563|OG002|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
10831582|NCT00134563|EG000|Reported Event|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
10831583|NCT00134563|EG001|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
10831584|NCT00134563|EG002|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
10842779|NCT00249470|EG000|Reported Event|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
10842780|NCT00249470|EG001|Reported Event|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
10842781|NCT00249496|BG000|Baseline|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
10842782|NCT00249496|BG001|Baseline|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
10842783|NCT00249496|BG002|Baseline|Total|Total of all reporting groups
10842784|NCT00249496|FG000|Participant Flow|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
10831585|NCT00134719|BG000|Baseline|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831586|NCT00134719|BG001|Baseline|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831587|NCT00134719|BG002|Baseline|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
10831588|NCT00134719|BG003|Baseline|Total|Total of all reporting groups
10831589|NCT00134719|FG000|Participant Flow|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831590|NCT00134719|FG001|Participant Flow|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831591|NCT00134719|FG002|Participant Flow|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
10831592|NCT00134719|OG000|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831593|NCT00134719|OG001|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831594|NCT00134719|OG002|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
10831595|NCT00134719|EG000|Reported Event|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831596|NCT00134719|EG001|Reported Event|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
10831597|NCT00134719|EG002|Reported Event|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
10831598|NCT00134784|BG000|Baseline|Placebo Group|Subjects on placebo
10831599|NCT00134784|BG001|Baseline|Levodopa 150mg/Day|Subjects on 150mg/day of Levodopa
10831600|NCT00134784|BG002|Baseline|Levodopa 300 mg/Day|Subjects on 300 mg/day of Levodopa
10831601|NCT00134784|BG003|Baseline|Levodopa 600 mg/Day|Subjects on Levodopa 600 mg/day
10831602|NCT00134784|BG004|Baseline|Total|Total of all reporting groups
10831603|NCT00134784|FG000|Participant Flow|Placebo|Placebo group
10831604|NCT00134784|FG001|Participant Flow|Levodopa 150mg/Day|Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
10831605|NCT00134784|FG002|Participant Flow|Levodopa 300 mg/Day|Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
10831606|NCT00134784|FG003|Participant Flow|Levodopa 600 mg/Day|Levodopa 600/day, [123I]ß-CIT and SPECT imaging
10831607|NCT00134784|OG000|Outcome|Placebo Group|Participants receiving placebo
10831608|NCT00134784|OG001|Outcome|Levodopa|Subjects on 150 mg/day of Levodopa
10831609|NCT00134784|OG002|Outcome|Levodopa 2|Subjects on 300 mg/day of Levodopa
10831610|NCT00134784|OG003|Outcome|Levodopa 3|Subjects on 600 mg/day of Levodopa
10831611|NCT00134784|EG000|Reported Event|I123BCIT|[123I]ß CIT and SPECT imaging' .
10831612|NCT00134901|BG000|Baseline|Memantine|Memantine 40mg/day
10831613|NCT00134901|BG001|Baseline|Placebo|Placebo daily dose
10831614|NCT00134901|BG002|Baseline|Total|Total of all reporting groups
10831615|NCT00134901|FG000|Participant Flow|Memantine|Memantine 40mg/day
10831616|NCT00134901|FG001|Participant Flow|Placebo|Placebo daily dose
10831617|NCT00134901|OG000|Outcome|Memantine|Memantine 40mg/day
10831618|NCT00134901|OG001|Outcome|Placebo|Placebo daily dose
10831619|NCT00134901|OG000|Outcome|Memantine|"Memantine~Memantine: Memantine"
10831620|NCT00134901|OG001|Outcome|Placebo|"Placebo~placebo: placebo"
10831621|NCT00134901|EG000|Reported Event|Memantine|Memantine 40mg/day
10831622|NCT00134901|EG001|Reported Event|Placebo|Placebo daily dose
10831623|NCT00135226|BG000|Baseline|Aspirin + Omega-3|Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily.
11095653|NCT01559116|EG001|Reported Event|Olodaterol (5 µg)|Olodaterol solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
10831624|NCT00135226|BG001|Baseline|Aspirin + Placebo Omega-3|Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily.
10831625|NCT00135226|BG002|Baseline|Placebo Aspirin + Omega-3|Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily.
10831626|NCT00135226|BG003|Baseline|Placebo Aspirin + Placebo Omega-3|Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily.
10831627|NCT00135226|BG004|Baseline|Total|Total of all reporting groups
10831628|NCT00135226|FG000|Participant Flow|Aspirin + Omega-3 Ethyl Esters|"Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily.~Aspirin~Omega-3 ethyl esters"
10831629|NCT00135226|FG001|Participant Flow|Aspirin + Placebo Omega-3 Ethyl Esters|"Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily.~Aspirin~Placebo omega-3 ethyl esters"
10831630|NCT00135226|FG002|Participant Flow|Placebo Aspirin + Omega-3 Ethyl Esters|"Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily.~Placebo aspirin~Omega-3 ethyl esters"
11095654|NCT01559116|EG002|Reported Event|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
11095655|NCT01559116|EG003|Reported Event|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
11095656|NCT01559116|EG004|Reported Event|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
11095657|NCT01559116|EG005|Reported Event|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
11095658|NCT01559129|BG000|Baseline|Placebo|Participants received placebo orally once a day for 52 weeks during the treatment phase. In the open-label extension phase participants transitioned to receive 1 mg pomalidomide orally once a day for up to 2 years.
11095659|NCT01559129|BG001|Baseline|Pomalidomide|Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase and continued to receive the same treatment for up to 2 years during the open-label extension phase.
11095660|NCT01559129|BG002|Baseline|Total|Total of all reporting groups
11095661|NCT01559129|FG000|Participant Flow|Placebo|Participants received placebo orally once a day for 52 weeks during the treatment phase. In the open-label extension phase participants transitioned to receive 1 mg pomalidomide orally once a day for up to 2 years.
11095662|NCT01559129|FG001|Participant Flow|Pomalidomide|Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase and continued to receive the same treatment for up to 2 years during the open-label extension phase.
11095663|NCT01559129|OG000|Outcome|Treatment Phase: Placebo|Participants received placebo orally once a day for 52 weeks during the treatment phase.
11095664|NCT01559129|OG001|Outcome|Treatment Phase: Pomalidomide|Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase.
11095665|NCT01559129|OG002|Outcome|Extension Phase: Placebo/Pomalidomide|In the open-label extension phase participants received 1 mg pomalidomide orally once a day for up to 2 years.
11095666|NCT01559129|OG003|Outcome|Extension Phase: Pomalidomide/Pomalidomide|Participants received 1 mg pomalidomide orally once a day for up to 2 years during the open-label extension phase.
11095667|NCT01559129|OG000|Outcome|Placebo|Participants received placebo orally once a day for 52 weeks during the treatment phase. In the open-label extension phase participants transitioned to receive 1 mg pomalidomide orally once a day for up to 2 years.
11095668|NCT01559129|OG001|Outcome|Pomalidomide|Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase and for up to 2 years during the open-label extension phase.
11095669|NCT01559129|EG000|Reported Event|Treatment Phase: Placebo|Participants received placebo orally once a day for 52 weeks during the treatment phase.
11095670|NCT01559129|EG001|Reported Event|Treatment Phase: Pomalidomide|Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase.
11095671|NCT01559129|EG002|Reported Event|Extension Phase: Placebo/Pomalidomide|In the open-label extension phase participants received 1 mg pomalidomide orally once a day for up to 2 years.
11095672|NCT01559129|EG003|Reported Event|Extension Phase: Pomalidomide/Pomalidomide|Participants received 1 mg pomalidomide orally once a day for up to 2 years during the open-label extension phase.
11095673|NCT01559259|BG000|Baseline|Placebo|Participants received Placebo as single oral dose caplets during the 12 hours study.
11095674|NCT01559259|BG001|Baseline|Ibuprofen 200 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095675|NCT01559259|BG002|Baseline|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095676|NCT01559259|BG003|Baseline|Ibuprofen 300 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095677|NCT01559259|BG004|Baseline|Ibuprofen 400 mg|Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
11095678|NCT01559259|BG005|Baseline|Total|Total of all reporting groups
11095679|NCT01559259|FG000|Participant Flow|Placebo|Participants received Placebo as single oral dose caplets during the 12 hours study.
11095680|NCT01559259|FG001|Participant Flow|Ibuprofen 200 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 200 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
11095681|NCT01559259|FG002|Participant Flow|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095682|NCT01559259|FG003|Participant Flow|Ibuprofen 300 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095683|NCT01559259|FG004|Participant Flow|Ibuprofen 400 mg|Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
11095684|NCT01559259|OG000|Outcome|Placebo|Participants received Placebo as single oral dose caplets during the 12 hours study.
10831631|NCT00135226|FG003|Participant Flow|Placebo Aspirin + Placebo Omega-3 Ethyl Esters|"Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily.~Placebo aspirin~Placebo omega-3 ethyl esters"
11095685|NCT01559259|OG001|Outcome|Ibuprofen 200 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095686|NCT01559259|OG002|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095687|NCT01559259|OG003|Outcome|Ibuprofen 300 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095688|NCT01559259|OG004|Outcome|Ibuprofen 400 mg|Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
11095689|NCT01559259|EG000|Reported Event|Placebo|Participants received Placebo as single oral dose caplets during the 12 hours study.
10831632|NCT00135226|OG000|Outcome|Aspirin|Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
10831633|NCT00135226|OG001|Outcome|Placebo Aspirin|Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
10831634|NCT00135226|OG002|Outcome|Omega-3|Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
10831635|NCT00135226|OG003|Outcome|Placebo Omega-3|Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
10831636|NCT00135226|OG000|Outcome|Omega-3|Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
10831637|NCT00135226|OG001|Outcome|Placebo Omega-3|Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
10831638|NCT00135226|EG000|Reported Event|Aspirin|Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
10831639|NCT00135226|EG001|Reported Event|Placebo Aspirin|Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
10831640|NCT00135226|EG002|Reported Event|Omega-3|Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
10831641|NCT00135226|EG003|Reported Event|Placebo Omega-3|Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
10831642|NCT00135330|BG000|Baseline|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
10831643|NCT00135330|BG001|Baseline|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
10831644|NCT00135330|BG002|Baseline|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
10831645|NCT00135330|BG003|Baseline|Total|Total of all reporting groups
10831646|NCT00135330|FG000|Participant Flow|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
10831647|NCT00135330|FG001|Participant Flow|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
10831648|NCT00135330|FG002|Participant Flow|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
10831649|NCT00135330|OG000|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
10831650|NCT00135330|OG001|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
10831651|NCT00135330|OG002|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
10831652|NCT00135330|EG000|Reported Event|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
10831653|NCT00135330|EG001|Reported Event|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
10831654|NCT00135330|EG002|Reported Event|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
10831655|NCT00135356|BG000|Baseline|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
10831656|NCT00135356|BG001|Baseline|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
10831657|NCT00135356|BG002|Baseline|Total|Total of all reporting groups
10831658|NCT00135356|FG000|Participant Flow|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
10831659|NCT00135356|FG001|Participant Flow|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
10831660|NCT00135356|OG000|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
10831661|NCT00135356|OG001|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
10831662|NCT00135356|EG000|Reported Event|ATV/RTV Switch Arm|
10831663|NCT00135356|EG001|Reported Event|PI/RTV Control Arm|
10831664|NCT00135512|BG000|Baseline|Bupropion SR|During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
10842785|NCT00249496|FG001|Participant Flow|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
10831665|NCT00135512|FG000|Participant Flow|Bupropion SR|During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets twice daily (BID; morning and evening) for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks was administered. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
10831666|NCT00135512|OG000|Outcome|Bupropion SR|During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
10831667|NCT00135512|EG000|Reported Event|Bupropion SR|During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.
10831668|NCT00135694|BG000|Baseline|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
10831669|NCT00135694|BG001|Baseline|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
10831670|NCT00135694|BG002|Baseline|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
10831671|NCT00135694|BG003|Baseline|Total|Total of all reporting groups
10831672|NCT00135694|FG000|Participant Flow|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
10831673|NCT00135694|FG001|Participant Flow|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
10831674|NCT00135694|FG002|Participant Flow|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
10831675|NCT00135694|OG000|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
10831676|NCT00135694|OG001|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
10831677|NCT00135694|OG000|Outcome|All Enrolled|Subjects who underwent liver transplantation in the trial.
10831678|NCT00135694|EG000|Reported Event|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
10831679|NCT00135694|EG001|Reported Event|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
10831680|NCT00135694|EG002|Reported Event|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
10831681|NCT00135707|BG000|Baseline|Daily Vitamin Supplements|1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.
10831682|NCT00135707|BG001|Baseline|Placebo for Vitamins C and E|Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.
10831683|NCT00135707|BG002|Baseline|Total|Total of all reporting groups
10831684|NCT00135707|FG000|Participant Flow|Vitamins|Vitamins C & E
10831685|NCT00135707|FG001|Participant Flow|Placebo|Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
10831686|NCT00135707|OG000|Outcome|Vitamins|Vitamins C & E
10831687|NCT00135707|OG001|Outcome|Placebo|Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
10831688|NCT00135707|OG000|Outcome|Dietary Supplement/Vitamins|"1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.~Dietary Supplement/Vitamins: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery."
10831689|NCT00135707|OG001|Outcome|Placebo for Vitamin C and Vitamin E|"Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.~Placebo for Vitamin C and Vitamin E: Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery."
10831690|NCT00135707|OG000|Outcome|Vitamins|"1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.~Dietary Supplement/Vitamins: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery."
10831691|NCT00135707|OG001|Outcome|Placebo|"Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.~Placebo for Vitamin C and Vitamin E: Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery."
10831692|NCT00135707|EG000|Reported Event|Vitamins|Vitamins C & E
10831693|NCT00135707|EG001|Reported Event|Placebo|Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
10831694|NCT00135798|BG000|Baseline|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
10831695|NCT00135798|BG001|Baseline|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
10831696|NCT00135798|BG002|Baseline|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
10831697|NCT00135798|BG003|Baseline|Total|Total of all reporting groups
10831698|NCT00135798|FG000|Participant Flow|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
10831699|NCT00135798|FG001|Participant Flow|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
10831700|NCT00135798|FG002|Participant Flow|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
10831701|NCT00135798|OG000|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
10831702|NCT00135798|OG001|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
10831703|NCT00135798|OG002|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
10831704|NCT00135798|EG000|Reported Event|Standard Clinical Care: Genotypes 1, 4, 6|Subjects who received no LADR treatment (Per Protocol analysis)
10831705|NCT00135798|EG001|Reported Event|LADR Treatment (All Genotypes)|This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
10831706|NCT00136084|BG000|Baseline|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
10831707|NCT00136084|BG001|Baseline|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
10831708|NCT00136084|BG002|Baseline|Total|Total of all reporting groups
10831709|NCT00136084|FG000|Participant Flow|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
10831710|NCT00136084|FG001|Participant Flow|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
10831711|NCT00136084|OG000|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
10831712|NCT00136084|OG001|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
10831713|NCT00136084|OG000|Outcome|Overall|Post-GO Treatment MRD
10831714|NCT00136084|OG000|Outcome|Overall|Patients who have no response to one course of induction therapy
10831715|NCT00136084|OG000|Outcome|Overall|Evaluation of all study participants
10831716|NCT00136084|OG000|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (Ara-C) (HDAC)
10831717|NCT00136084|OG001|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (Ara-C) (LDAC)
10831718|NCT00136084|OG000|Outcome|Overall|17 of the 232 eligible patients
10831719|NCT00136084|EG000|Reported Event|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
10831720|NCT00136084|EG001|Reported Event|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
10831721|NCT00136214|BG000|Baseline|Interferon Treated Group|"Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831722|NCT00136214|BG001|Baseline|Non-treated Cohort Control|"Group undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831723|NCT00136214|BG002|Baseline|Total|Total of all reporting groups
10831724|NCT00136214|FG000|Participant Flow|Interferon Treated Group|"Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831725|NCT00136214|FG001|Participant Flow|Non-treated Cohort Control|"Group undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831726|NCT00136214|OG000|Outcome|Interferon Treated Group|"Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests Significant reductions in basal ganglia Cho/Cr (p = 0.03) and basal ganglia MI/Cr (p = 0.03) were observed in sustained virological responders (SVRs, n = 8), but not non-responders/ relapsers (NR/R, n = 6), indicative of reduced cerebral infection and/or immune activation in those who cleared virus. SVRs demonstrated significant improvements in verbal learning, memory, and visuo-spatial memory."
10831727|NCT00136214|OG001|Outcome|Non-treated Cohort Control|"Group undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests~A small but significant improvement in neurocognitive function secondary to the practice effect was seen in both HCV controls and HCV subjects during treatment."
10831728|NCT00136214|OG000|Outcome|Interferon Treated Group|Group treated with PEG-Interferon and ribavirin and undergoing neuropsychiatric tests
10831729|NCT00136214|OG001|Outcome|Non-treated Cohort Control|Group undergoing neuropsychiatric tests
10831730|NCT00136214|EG000|Reported Event|Interferon Treated Group|"Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831731|NCT00136214|EG001|Reported Event|Non-treated Cohort Control|"Group undergoing MR brain and neuropsychiatric tests~MR brain and neuropsychiatric tests"
10831732|NCT00136318|BG000|Baseline|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
10831733|NCT00136318|BG001|Baseline|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
10831734|NCT00136318|BG002|Baseline|Total|Total of all reporting groups
11095690|NCT01559259|EG001|Reported Event|Ibuprofen 200 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
10831735|NCT00136318|FG000|Participant Flow|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
10831736|NCT00136318|FG001|Participant Flow|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
10831737|NCT00136318|OG000|Outcome|Escitalopram|"After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
10831738|NCT00136318|OG001|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
10831739|NCT00136318|OG000|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
10831740|NCT00136318|EG000|Reported Event|Escitalopram|
10831741|NCT00136318|EG001|Reported Event|Placebo|
10831742|NCT00136357|BG000|Baseline|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
10831743|NCT00136357|BG001|Baseline|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
10831744|NCT00136357|BG002|Baseline|Total|Total of all reporting groups
10831745|NCT00136357|FG000|Participant Flow|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
10831746|NCT00136357|FG001|Participant Flow|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
10831747|NCT00136357|OG000|Outcome|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
10831748|NCT00136357|OG001|Outcome|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
10831749|NCT00136357|EG000|Reported Event|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
10831750|NCT00136357|EG001|Reported Event|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
10831751|NCT00136604|BG000|Baseline|ACAC GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831752|NCT00136604|BG001|Baseline|ACHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831753|NCT00136604|BG002|Baseline|HibACPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831754|NCT00136604|BG003|Baseline|HibHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10831755|NCT00136604|BG004|Baseline|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831756|NCT00136604|BG005|Baseline|Total|Total of all reporting groups
10831757|NCT00136604|FG000|Participant Flow|ACAC GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10842786|NCT00249496|OG000|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
10831758|NCT00136604|FG001|Participant Flow|ACHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831759|NCT00136604|FG002|Participant Flow|HibACPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831760|NCT00136604|FG003|Participant Flow|HibHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10831761|NCT00136604|FG004|Participant Flow|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831762|NCT00136604|OG000|Outcome|ACAC GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831763|NCT00136604|OG001|Outcome|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831764|NCT00136604|OG001|Outcome|ACHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831765|NCT00136604|OG002|Outcome|HibACPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831766|NCT00136604|OG003|Outcome|HibHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10831767|NCT00136604|OG004|Outcome|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831768|NCT00136604|OG001|Outcome|HibACPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831769|NCT00136604|OG002|Outcome|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831770|NCT00136604|OG002|Outcome|HibHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10831771|NCT00136604|EG000|Reported Event|ACAC GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831772|NCT00136604|EG001|Reported Event|ACHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
11095691|NCT01559259|EG002|Reported Event|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095692|NCT01559259|EG003|Reported Event|Ibuprofen 300 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
11095693|NCT01559259|EG004|Reported Event|Ibuprofen 400 mg|Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
11095694|NCT01559311|BG000|Baseline|CRT-P OFF|Echo-guided Group - DDDR Standard Therapy
11095695|NCT01559311|BG001|Baseline|CRT-P ON|Echo-guided Group - CRT-P Standard Therapy
11095696|NCT01559311|BG002|Baseline|DDDR|Control Group - DDDR Standard Therapy
11095697|NCT01559311|BG003|Baseline|Total|Total of all reporting groups
11095698|NCT01559311|FG000|Participant Flow|CRT-P OFF|Echo-guided Group - Dual chamber pacemaker (DDDR) Standard Therapy
11095699|NCT01559311|FG001|Participant Flow|CRT-P ON|Echo-guided Group - Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
11095700|NCT01559311|FG002|Participant Flow|DDDR|Control Group - DDDR Standard Therapy
11095701|NCT01559311|OG000|Outcome|CRT-P OFF|Echo-guided Group - DDDR Standard Therapy
11095702|NCT01559311|OG001|Outcome|CRT-P ON|Echo-guided Group - CRT-P Standard Therapy
11095703|NCT01559311|OG002|Outcome|DDDR|Control Group - DDDR Standard Therapy
11095704|NCT01559311|EG000|Reported Event|CRT-P OFF|Echo-guided Group - DDDR Standard Therapy
11095705|NCT01559311|EG001|Reported Event|CRT-P ON|Echo-guided Group - CRT-P Standard Therapy
11095706|NCT01559311|EG002|Reported Event|DDDR|Control Group - DDDR Standard Therapy
11095707|NCT01559389|BG000|Baseline|Females With UUI|This arm comprises females who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
11095708|NCT01559389|BG001|Baseline|Male Partners|This arm comprises the healthy male partners of the female participants
11095709|NCT01559389|BG002|Baseline|Total|Total of all reporting groups
11095710|NCT01559389|FG000|Participant Flow|Females With UUI|This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
11095711|NCT01559389|FG001|Participant Flow|Male Partners|This arm comprises the healthy male partners of the female participants
11095712|NCT01559389|OG000|Outcome|Females With UUI|This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
11095713|NCT01559389|OG001|Outcome|Male Partners|This arm comprises the healthy male partners of the female participants
11095714|NCT01559389|OG000|Outcome|Responder|"This arm comprises female participants who respond to solifenacin treatment for their UUI symptoms. Response to treatment comprises those who rate their Global Impression of Improvement (GII) as a little better, much better, or very much better"
11095715|NCT01559389|OG001|Outcome|Non-Responder|"This arm comprises female participants who do not respond to solifenacin treatment for their UUI symptoms. Non-response to treatment is defined as those who rate their Global Impression of Improvement (GII) as no change, a little worse, much worse, and very much worse."
11095716|NCT01559389|OG000|Outcome|Male Partners of Female Responders|This arm comprises the male partners of female participants who respond to solifenacin treatment for their UUI symptoms
11095717|NCT01559389|OG001|Outcome|Male Partners of Female Non-Responders|This arm comprises the male partners of female participants who do not respond to solifenacin treatment for their UUI symptoms
11095718|NCT01559389|EG000|Reported Event|Females With UUI|This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
11095719|NCT01559389|EG001|Reported Event|Male Partners|This arm comprises the healthy male partners of the female participants. They were not prescribed solifenacin and, consequently, were not at risk for adverse events
11095720|NCT01559454|BG000|Baseline|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
11095721|NCT01559454|BG001|Baseline|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
11095722|NCT01559454|BG002|Baseline|Total|Total of all reporting groups
11095723|NCT01559454|FG000|Participant Flow|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
11095724|NCT01559454|FG001|Participant Flow|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
11095725|NCT01559454|OG000|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
11095726|NCT01559454|OG001|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
11095727|NCT01559454|EG000|Reported Event|Methadone|Methadone 10-60 mg/day divided 2-4 times a day for 6 months
11095728|NCT01559454|EG001|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
11095729|NCT01559506|BG000|Baseline|No Device|Subject does not receive ABS system
11095730|NCT01559506|BG001|Baseline|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
11095731|NCT01559506|BG002|Baseline|Total|Total of all reporting groups
11095732|NCT01559506|FG000|Participant Flow|No Device|Subject does not receive ABS system
11095733|NCT01559506|FG001|Participant Flow|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
11095734|NCT01559506|OG000|Outcome|No Device|Subject does not receive ABS system
11095735|NCT01559506|OG001|Outcome|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
11095736|NCT01559506|EG000|Reported Event|No Device|Subject does not receive ABS system
11095737|NCT01559506|EG001|Reported Event|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
11095738|NCT01559649|BG000|Baseline|Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
11095739|NCT01559649|BG001|Baseline|Nurses|Registered nurses working on MEDVAMC stroke wards
11095740|NCT01559649|BG002|Baseline|Total|Total of all reporting groups
11328364|NCT03426995|OG003|Outcome|Part A: GSK3358699 10 mg SD|Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
10831773|NCT00136604|EG002|Reported Event|HibACPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10831774|NCT00136604|EG003|Reported Event|HibHibPS GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10831775|NCT00136604|EG004|Reported Event|CC GROUP|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
10831776|NCT00136695|BG000|Baseline|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
10831777|NCT00136695|BG001|Baseline|Placebo|"placebo~anastrozole: 1 mg QD"
10831778|NCT00136695|BG002|Baseline|Total|Total of all reporting groups
10831779|NCT00136695|FG000|Participant Flow|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
10831780|NCT00136695|FG001|Participant Flow|Placebo|"placebo~anastrozole: 1 mg QD"
10831781|NCT00136695|OG000|Outcome|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
10831782|NCT00136695|OG001|Outcome|Placebo|"placebo~anastrozole: 1 mg QD"
10831783|NCT00136695|EG000|Reported Event|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
10831784|NCT00136695|EG001|Reported Event|Placebo|"placebo~anastrozole: 1 mg QD"
10831785|NCT00136760|BG000|Baseline|CM + BUP|Contingent reinforcement plus bupropion
10831786|NCT00136760|BG001|Baseline|CM + PLA|Contingent reinforcement plus placebo
10831787|NCT00136760|BG002|Baseline|NR + BUP|Non-contingent reinforcement plus bupropion
10831788|NCT00136760|BG003|Baseline|NR + PLA|Non-contingent reinforcement plus placebo
10831789|NCT00136760|BG004|Baseline|Total|Total of all reporting groups
10831790|NCT00136760|FG000|Participant Flow|CM + BUP|Contingent reinforcement plus bupropion
10831791|NCT00136760|FG001|Participant Flow|CM + PLA|Contingent reinforcement plus placebo
10831792|NCT00136760|FG002|Participant Flow|NR + BUP|Non-contingent reinforcement plus bupropion
10831793|NCT00136760|FG003|Participant Flow|NR + PLA|Non-contingent reinforcement plus placebo
10831794|NCT00136760|OG000|Outcome|CM + BUP|Contingent reinforcement plus bupropion
10831795|NCT00136760|OG001|Outcome|CM + PLA|Contingent reinforcement plus placebo
10831796|NCT00136760|OG002|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
10831797|NCT00136760|OG003|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
10831798|NCT00136760|EG000|Reported Event|CM + BUP|Contingent reinforcement plus bupropion
10831799|NCT00136760|EG001|Reported Event|CM + PLA|Contingent reinforcement plus placebo
10831800|NCT00136760|EG002|Reported Event|NR + BUP|Non-contingent reinforcement plus bupropion
10831801|NCT00136760|EG003|Reported Event|NR + PLA|Non-contingent reinforcement plus placebo
10831802|NCT00136812|BG000|Baseline|Control|Usual care provided NRT during hospitalization with brief cessation advice.
10831803|NCT00136812|BG001|Baseline|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
10831804|NCT00136812|BG002|Baseline|Total|Total of all reporting groups
10831805|NCT00136812|FG000|Participant Flow|Control|Usual care provided NRT during hospitalization with brief cessation advice.
10831806|NCT00136812|FG001|Participant Flow|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
10831807|NCT00136812|OG000|Outcome|Control|Usual care provided NRT during hospitalization with brief cessation advice.
10831808|NCT00136812|OG001|Outcome|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
10831809|NCT00136812|EG000|Reported Event|1: Enhanced Standard Care Control|enhanced standard care control
10831810|NCT00136812|EG001|Reported Event|2: Intervention|"intervention~Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge."
10831811|NCT00136838|BG000|Baseline|Study Participants|This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
10831812|NCT00136838|FG000|Participant Flow|Neutral Cue First, Then Active Cue|"Participants receives two consecutive interventions in random order.~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue"
10831813|NCT00136838|FG001|Participant Flow|Active Cue First, Then Neutral Cue|"Each participant receives two consecutive interventions in random order.~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue"
10831814|NCT00136838|OG000|Outcome|Active Cue|During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
10831815|NCT00136838|OG001|Outcome|Neutral Cue|During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
10831816|NCT00136838|OG000|Outcome|Active Cue Craving|intensity of craving following cue exposure
10831817|NCT00136838|OG001|Outcome|Neutral Cue Craving|intensity of craving following cue exposure
10831818|NCT00136838|EG000|Reported Event|Neutral Cue|Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
10831819|NCT00136838|EG001|Reported Event|Active Cue|1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
10831820|NCT00136916|BG000|Baseline|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
10831821|NCT00136916|BG001|Baseline|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
10831822|NCT00136916|BG002|Baseline|Total|Total of all reporting groups
10831823|NCT00136916|FG000|Participant Flow|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
10831824|NCT00136916|FG001|Participant Flow|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
10831825|NCT00136916|OG000|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
10831826|NCT00136916|OG001|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
10831827|NCT00136916|OG000|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
10831828|NCT00136916|OG001|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
10831829|NCT00136916|EG000|Reported Event|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
10831830|NCT00136916|EG001|Reported Event|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
10831831|NCT00136955|BG000|Baseline|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
10831832|NCT00136955|FG000|Participant Flow|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
10831833|NCT00136955|OG000|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
10831834|NCT00136955|EG000|Reported Event|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
10831835|NCT00137046|BG000|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831836|NCT00137046|BG001|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831837|NCT00137046|BG002|Baseline|Total|Total of all reporting groups
10831838|NCT00137046|FG000|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831839|NCT00137046|FG001|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831840|NCT00137046|OG000|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831841|NCT00137046|OG001|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831842|NCT00137046|OG000|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831843|NCT00137046|OG001|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831844|NCT00137046|OG000|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831845|NCT00137046|OG001|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831846|NCT00137046|EG000|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10831847|NCT00137046|EG001|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831848|NCT00137111|BG000|Baseline|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
10831849|NCT00137111|BG001|Baseline|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
10831850|NCT00137111|BG002|Baseline|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
10831851|NCT00137111|BG003|Baseline|Non Randomized|Patients not randomized for window study
10831852|NCT00137111|BG004|Baseline|Total|Total of all reporting groups
10831853|NCT00137111|FG000|Participant Flow|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
10831854|NCT00137111|FG001|Participant Flow|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
10831855|NCT00137111|FG002|Participant Flow|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
10831856|NCT00137111|FG003|Participant Flow|Non Randomized|Patients not randomized for window study
10831857|NCT00137111|OG000|Outcome|Total Therapy|Total therapy applies to all eligible patients.
10831858|NCT00137111|OG000|Outcome|Patients With High Risk of CNS Relapse|This is a subset of all patients enrolled. It is not a specific treatment arm.
10831859|NCT00137111|OG000|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
10831860|NCT00137111|OG001|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
10831861|NCT00137111|EG000|Reported Event|Total Therapy|Total therapy applies to all eligible patients.
10831862|NCT00137267|BG000|Baseline|Arm 1 - Time Limited Case Management (TLC)|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
10831863|NCT00137267|BG001|Baseline|Arm 2 - Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
10831864|NCT00137267|BG002|Baseline|Total|Total of all reporting groups
10831865|NCT00137267|FG000|Participant Flow|Time Limited Case Management|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
10831866|NCT00137267|FG001|Participant Flow|Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group."
10831867|NCT00137267|OG000|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
10831868|NCT00137267|OG001|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
10842787|NCT00249496|OG001|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
10831869|NCT00137267|EG000|Reported Event|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
10831870|NCT00137267|EG001|Reported Event|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
10831871|NCT00137280|BG000|Baseline|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
10831872|NCT00137280|BG001|Baseline|Usual Care|Continue with usual care
10831873|NCT00137280|BG002|Baseline|Total|Total of all reporting groups
10831874|NCT00137280|FG000|Participant Flow|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
10831875|NCT00137280|FG001|Participant Flow|Usual Care|Continue with usual care
10831876|NCT00137280|OG000|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
10831877|NCT00137280|OG001|Outcome|Usual Care|Continue with usual care
10831878|NCT00137280|EG000|Reported Event|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
10831879|NCT00137280|EG001|Reported Event|Usual Care|Continue with usual care
10831880|NCT00137423|BG000|Baseline|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831881|NCT00137423|BG001|Baseline|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831882|NCT00137423|BG002|Baseline|Total|Total of all reporting groups
10831883|NCT00137423|FG000|Participant Flow|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831884|NCT00137423|FG001|Participant Flow|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831885|NCT00137423|OG000|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
10831886|NCT00137423|OG001|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
10831887|NCT00137423|OG000|Outcome|AM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
10842788|NCT00249496|OG000|Outcome|Employment Only|Employment Only participants were offered employment for one year, but these participants did not have to provide drug-free urine samples to work.
10842789|NCT00249496|OG001|Outcome|Contingency Management|Participants in the Contingency Management group were employed for one year in a Therapeutic Workplace business and had to provide drug-free urine samples to work and earn salary.
10831888|NCT00137423|OG001|Outcome|PM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831889|NCT00137423|OG000|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831890|NCT00137423|OG001|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
10831891|NCT00137423|EG000|Reported Event|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
10831892|NCT00137423|EG001|Reported Event|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
10831893|NCT00137436|BG000|Baseline|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
10831894|NCT00137436|FG000|Participant Flow|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
10831895|NCT00137436|OG000|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
10831896|NCT00137436|EG000|Reported Event|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
10831897|NCT00137449|BG000|Baseline|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831898|NCT00137449|BG001|Baseline|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831899|NCT00137449|BG002|Baseline|Total|Total of all reporting groups
10831900|NCT00137449|FG000|Participant Flow|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831901|NCT00137449|FG001|Participant Flow|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831902|NCT00137449|OG000|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831903|NCT00137449|OG001|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831904|NCT00137449|OG002|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831905|NCT00137449|EG000|Reported Event|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831906|NCT00137449|EG001|Reported Event|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
10831907|NCT00137631|BG000|Baseline|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
10831908|NCT00137631|BG001|Baseline|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
10831909|NCT00137631|BG002|Baseline|Total|Total of all reporting groups
10831910|NCT00137631|FG000|Participant Flow|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
10831911|NCT00137631|FG001|Participant Flow|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
10831912|NCT00137631|OG000|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
10831913|NCT00137631|OG001|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
10831914|NCT00137631|EG000|Reported Event|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
10831915|NCT00137631|EG001|Reported Event|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
10831916|NCT00137839|BG000|Baseline|Erlotinib|Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
10831917|NCT00137839|FG000|Participant Flow|Erlotinib|Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
10831918|NCT00137839|OG000|Outcome|Erlotinib|Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
10831919|NCT00137839|OG000|Outcome|EGFR Mutant|Mutation status of the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
10831920|NCT00137839|OG001|Outcome|EGFR Wild Type|Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
10831921|NCT00137839|OG002|Outcome|Unevaluable EGFR|Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
10831922|NCT00137839|EG000|Reported Event|Erlotinib|Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
10831923|NCT00137969|BG000|Baseline|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831924|NCT00137969|BG001|Baseline|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831925|NCT00137969|BG002|Baseline|Total|Total of all reporting groups
10831926|NCT00137969|FG000|Participant Flow|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831927|NCT00137969|FG001|Participant Flow|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
11328365|NCT03426995|OG004|Outcome|Part A: GSK3358699 20 mg SD|Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
11336154|NCT03562377|OG001|Outcome|Placebo|Participants received placebo every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12.
11336155|NCT03562377|EG000|Reported Event|Tralokinumab|Tralokinumab
10831928|NCT00137969|OG000|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831929|NCT00137969|OG001|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831930|NCT00137969|EG000|Reported Event|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831931|NCT00137969|EG001|Reported Event|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
10831932|NCT00138034|BG000|Baseline|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
10831933|NCT00138034|BG001|Baseline|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
10831934|NCT00138034|BG002|Baseline|Total|Total of all reporting groups
10831935|NCT00138034|FG000|Participant Flow|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
10831936|NCT00138034|FG001|Participant Flow|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
10831937|NCT00138034|OG000|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
10831938|NCT00138034|OG001|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
10831939|NCT00138034|EG000|Reported Event|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
11336156|NCT03562377|EG001|Reported Event|Placebo|Placebo
10831940|NCT00138034|EG001|Reported Event|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
11095741|NCT01559649|FG000|Participant Flow|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
11095742|NCT01559649|FG001|Participant Flow|Registered Nurses|Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
11095743|NCT01559649|OG000|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
11095744|NCT01559649|OG001|Outcome|Registered Nurses|Stroke ward nurses.
11095745|NCT01559649|OG001|Outcome|Registered Nurses|Stroke ward nurses
11095746|NCT01559649|OG000|Outcome|Nurses|Only nurses administered and interpreted the screening items.
11095747|NCT01559649|EG000|Reported Event|Patients With Suspected Stroke|Individuals admitted with suspected ischemic or hemorrhagic stroke
11095748|NCT01559675|BG000|Baseline|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
11095749|NCT01559675|BG001|Baseline|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
11095750|NCT01559675|BG002|Baseline|Total|Total of all reporting groups
11095751|NCT01559675|FG000|Participant Flow|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
11095752|NCT01559675|FG001|Participant Flow|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
11095753|NCT01559675|OG000|Outcome|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
11095754|NCT01559675|OG001|Outcome|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
11095755|NCT01559675|EG000|Reported Event|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
11095756|NCT01559675|EG001|Reported Event|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
11095757|NCT01559844|BG000|Baseline|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
11095758|NCT01559844|FG000|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
11095759|NCT01559844|OG000|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
11095760|NCT01559844|EG000|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
11095761|NCT01559857|BG000|Baseline|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
11095762|NCT01559857|BG001|Baseline|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
11095763|NCT01559857|BG002|Baseline|Total|Total of all reporting groups
11095764|NCT01559857|FG000|Participant Flow|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
11095765|NCT01559857|FG001|Participant Flow|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
11095766|NCT01559857|OG000|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
11095767|NCT01559857|OG001|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
11095768|NCT01559857|OG002|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
11095769|NCT01559857|OG003|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
11095770|NCT01559857|EG000|Reported Event|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
11095771|NCT01559857|EG001|Reported Event|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
11095772|NCT01559922|BG000|Baseline|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
11095773|NCT01559922|BG001|Baseline|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
11095774|NCT01559922|BG002|Baseline|Total|Total of all reporting groups
11095775|NCT01559922|FG000|Participant Flow|Placebo|Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
11095776|NCT01559922|FG001|Participant Flow|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
11095777|NCT01559922|OG000|Outcome|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
11095778|NCT01559922|OG001|Outcome|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
11095779|NCT01559922|EG000|Reported Event|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
11095780|NCT01559922|EG001|Reported Event|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
11095781|NCT01559948|BG000|Baseline|Lumbopelvic Stabilization Exc + Belt|These participants received a lumbopelvic exercise program plus a pelvic compression belt to wear for the the first four weeks of the study.
11095782|NCT01559948|BG001|Baseline|Lumbopelvic Stabilization Exc|The participants received a lumbopelvic exercise program.
11095783|NCT01559948|BG002|Baseline|Total|Total of all reporting groups
11095784|NCT01559948|FG000|Participant Flow|Lumbopelvic Stabilization Exc + Belt|"The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.~Sacroiliac joint belt: Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt."
11095785|NCT01559948|FG001|Participant Flow|Lumbopelvic Stabilization Exercise|"The participants will be instructed in a lumbopelvic stabilization program.~Lumbopelvic stabilization exercise: The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria."
11328366|NCT03426995|OG005|Outcome|Part A: GSK3358699 25 mg SD|Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
11095786|NCT01559948|OG000|Outcome|Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt|"The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.~Sacroiliac joint belt: Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt."
11095787|NCT01559948|OG001|Outcome|Lumbopelvic Stabilization Exercise|"The participants will be instructed in a lumbopelvic stabilization program.~Lumbopelvic stabilization exercise: The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria."
11095788|NCT01559948|OG000|Outcome|Lumbopelvic Stabilization Exc + Belt|"The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.~Sacroiliac joint belt: Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt."
11095789|NCT01559948|OG000|Outcome|Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt|These participants received a lumbopelvic exercise program plus a pelvic compression belt to wear for the the first four weeks of the study.
11095790|NCT01559948|OG001|Outcome|Lumbopelvic Stabilization Excercise|The participants received a lumbopelvic exercise program.
11095791|NCT01559948|OG000|Outcome|Lumbopelvic Stabilization Excercise Plus Sacroiliac Joint Belt|These participants received a lumbopelvic exercise program plus a pelvic compression belt to wear for the the first four weeks of the study.
11095792|NCT01559948|EG000|Reported Event|Lumbopelvic Stabilization Exc + Belt|"The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.~Sacroiliac joint belt: Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt."
11095793|NCT01559948|EG001|Reported Event|Lumbopelvic Stabilization Exercise|"The participants will be instructed in a lumbopelvic stabilization program.~Lumbopelvic stabilization exercise: The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria."
11095794|NCT01560143|BG000|Baseline|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
11095795|NCT01560143|FG000|Participant Flow|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
11095796|NCT01560143|OG000|Outcome|Serum AUC of Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
11095797|NCT01560143|EG000|Reported Event|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
11095798|NCT01560234|BG000|Baseline|Placebo|Commercial 0.9% sodium chloride solution.
11095799|NCT01560234|BG001|Baseline|Cohort 1|AZD8848 0.15 μg
11095800|NCT01560234|BG002|Baseline|Cohort 2|AZD8848 0.5 ug
11095801|NCT01560234|BG003|Baseline|Cohort 3|AZD8848 1.5 μg
11095802|NCT01560234|BG004|Baseline|Cohort 4|AZD8848 5 μg
11095803|NCT01560234|BG005|Baseline|Cohort 5|AZD8848 15 μg
11095804|NCT01560234|BG006|Baseline|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
11095805|NCT01560234|BG007|Baseline|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
11095806|NCT01560234|BG008|Baseline|Total|Total of all reporting groups
11095807|NCT01560234|FG000|Participant Flow|Placebo|Commercial 0.9% sodium chloride solution.
11095808|NCT01560234|FG001|Participant Flow|Cohort 1|AZD8848 0.15 μg
11095809|NCT01560234|FG002|Participant Flow|Cohort 2|AZD8848 0.5 ug
11095810|NCT01560234|FG003|Participant Flow|Cohort 3|AZD8848 1.5 μg
11095811|NCT01560234|FG004|Participant Flow|Cohort 4|AZD8848 5 μg
11095812|NCT01560234|FG005|Participant Flow|Cohort 5|AZD8848 15 μg
11095813|NCT01560234|FG006|Participant Flow|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
11095814|NCT01560234|FG007|Participant Flow|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
11095815|NCT01560234|OG000|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
11095816|NCT01560234|OG001|Outcome|Cohort 1|AZD8848 0.15 μg
11095817|NCT01560234|OG002|Outcome|Cohort 2|AZD8848 0.5 ug
11095818|NCT01560234|OG003|Outcome|Cohort 3|AZD8848 1.5 μg
11095819|NCT01560234|OG004|Outcome|Cohort 4|AZD8848 5 μg
11095820|NCT01560234|OG005|Outcome|Cohort 5|AZD8848 15 μg
11095821|NCT01560234|OG006|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
11095822|NCT01560234|OG007|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
11095823|NCT01560234|EG000|Reported Event|Placebo|Commercial 0.9% sodium chloride solution.
11095824|NCT01560234|EG001|Reported Event|Cohort 1|AZD8848 0.15 μg
11095825|NCT01560234|EG002|Reported Event|Cohort 2|AZD8848 0.5 ug
11095826|NCT01560234|EG003|Reported Event|Cohort 3|AZD8848 1.5 μg
11095827|NCT01560234|EG004|Reported Event|Cohort 4|AZD8848 5 μg
11095828|NCT01560234|EG005|Reported Event|Cohort 5|AZD8848 15 μg
11095829|NCT01560234|EG006|Reported Event|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
11095830|NCT01560234|EG007|Reported Event|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
11095831|NCT01560260|BG000|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095832|NCT01560260|FG000|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095833|NCT01560260|OG000|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095834|NCT01560260|OG000|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095835|NCT01560260|OG000|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095836|NCT01560260|EG000|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
11095837|NCT01560286|BG000|Baseline|rAvPAL-PEG|All 24 Enrolled Subjects
11095838|NCT01560286|FG000|Participant Flow|BMN 165 (rAvPAL-PEG)|
11095839|NCT01560286|OG000|Outcome|rAvPAL-PEG|All 24 Enrolled Subjects
11095840|NCT01560286|EG000|Reported Event|rAvPAL-PEG|All 24 Enrolled Subjects
11095841|NCT01560377|BG000|Baseline|Subjects Imaged With PINPOINT|"Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.~PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery"
11095842|NCT01560377|FG000|Participant Flow|Subjects Imaged With PINPOINT|"Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.~PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery"
11095843|NCT01560377|OG000|Outcome|Subjects Imaged With PINPOINT|"Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.~PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery"
11095844|NCT01560377|EG000|Reported Event|Subjects Imaged With PINPOINT|"Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.~PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery"
11095845|NCT01560403|BG000|Baseline|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
11095846|NCT01560403|BG001|Baseline|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
11095847|NCT01560403|BG002|Baseline|Total|Total of all reporting groups
11095848|NCT01560403|FG000|Participant Flow|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
11095849|NCT01560403|FG001|Participant Flow|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
11095850|NCT01560403|OG000|Outcome|NT,PBO/TED|This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.
10831941|NCT00138125|BG000|Baseline|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
10831942|NCT00138125|FG000|Participant Flow|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
10831943|NCT00138125|OG000|Outcome|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
10831944|NCT00138125|OG000|Outcome|Arm I|"see intervention description for details~Faslodex: Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin: Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
10831945|NCT00138125|EG000|Reported Event|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
10831946|NCT00138203|BG000|Baseline|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
10831947|NCT00138203|FG000|Participant Flow|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
10831948|NCT00138203|OG000|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
10831949|NCT00138203|OG000|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
10831950|NCT00138203|EG000|Reported Event|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
10831951|NCT00138294|BG000|Baseline|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
10831952|NCT00138294|FG000|Participant Flow|Intervention Cities|Eligible children 4 years of age and older whose parents provided consent (assent for children>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
10831953|NCT00138294|OG000|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
10831954|NCT00138294|OG001|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
10831955|NCT00138294|OG000|Outcome|Influenza Vaccine|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Serious adverse events (SAEs) and MAARI adverse events within 42 days post-LAIV vaccination were captured in seasonal and pandemic LAIV vaccinated study subjects in the intervention area.
10831956|NCT00138294|EG000|Reported Event|All Enrolled Study Participants|Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
10831957|NCT00138424|BG000|Baseline|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831958|NCT00138424|BG001|Baseline|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831959|NCT00138424|BG002|Baseline|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831960|NCT00138424|BG003|Baseline|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831961|NCT00138424|BG004|Baseline|Total|Total of all reporting groups
10831962|NCT00138424|FG000|Participant Flow|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831963|NCT00138424|FG001|Participant Flow|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831964|NCT00138424|FG002|Participant Flow|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831965|NCT00138424|FG003|Participant Flow|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831966|NCT00138424|OG000|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831967|NCT00138424|OG001|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831968|NCT00138424|OG002|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831969|NCT00138424|OG003|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831970|NCT00138424|OG000|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
10831971|NCT00138424|OG001|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
10831972|NCT00138424|EG000|Reported Event|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831973|NCT00138424|EG001|Reported Event|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
10831974|NCT00138424|EG002|Reported Event|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831975|NCT00138424|EG003|Reported Event|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
10831976|NCT00138645|BG000|Baseline|MicroDiet|MicroDiet
10831977|NCT00138645|BG001|Baseline|Healthy Diet|Healthy Diet
10831978|NCT00138645|BG002|Baseline|Total|Total of all reporting groups
10831979|NCT00138645|FG000|Participant Flow|MicroDiet|MicroDiet
10831980|NCT00138645|FG001|Participant Flow|Healthy Diet|Healthy Diet
10831981|NCT00138645|OG000|Outcome|MicroDiet|MicroDiet
10831982|NCT00138645|OG001|Outcome|Healthy Diet|Healthy Diet
10831983|NCT00138645|EG000|Reported Event|MicroDiet|Participants randomized to the MicroDiet
10831984|NCT00138645|EG001|Reported Event|Healthy Diet|participants randomized to the low-calorie diet.
10831985|NCT00138658|BG000|Baseline|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
10831986|NCT00138658|FG000|Participant Flow|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
10831987|NCT00138658|OG000|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
10831988|NCT00138658|OG000|Outcome|Mean Reduction in Serum Clusterin From Baseline|The mean reduction in serum clusterin was calculated by determining the difference from baseline to the minimum post baseline level. The reduction in serum clusterin was determined for all subjects who had baseline and at least one post-baseline serum clusterin assessment (n=55).
10831989|NCT00138658|OG000|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
10831990|NCT00138658|EG000|Reported Event|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
10831991|NCT00138671|BG000|Baseline|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831992|NCT00138671|BG001|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831993|NCT00138671|BG002|Baseline|Total|Total of all reporting groups
10831994|NCT00138671|FG000|Participant Flow|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831995|NCT00138671|FG001|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831996|NCT00138671|OG000|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831997|NCT00138671|OG001|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10831998|NCT00138671|OG000|Outcome|Inhaled Insulin|
10831999|NCT00138671|OG001|Outcome|Subcutaneous Insulin|
10832000|NCT00138671|EG000|Reported Event|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832001|NCT00138671|EG001|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832002|NCT00139399|BG000|Baseline|Saphenous Vein|"Saphenous vein aortocoronary bypass graft~Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery"
10832003|NCT00139399|BG001|Baseline|Radial Artery|"Radial artery aortocoronary bypass graft~Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery"
10832004|NCT00139399|BG002|Baseline|Total|Total of all reporting groups
11095851|NCT01560403|OG001|Outcome|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
11095852|NCT01560403|EG000|Reported Event|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
11095853|NCT01560403|EG001|Reported Event|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
10832005|NCT00139399|FG000|Participant Flow|Saphenous Vein|"Saphenous vein aortocoronary bypass graft~Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery"
10832006|NCT00139399|FG001|Participant Flow|Radial Artery|"Radial artery aortocoronary bypass graft~Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery"
10832007|NCT00139399|OG000|Outcome|Saphenous Vein|"Saphenous vein aortocoronary bypass graft~Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery"
10832008|NCT00139399|OG001|Outcome|Radial Artery|"Radial artery aortocoronary bypass graft~Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery"
10832009|NCT00139399|EG000|Reported Event|Saphenous Vein|"Saphenous vein aortocoronary bypass graft~Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery"
10832010|NCT00139399|EG001|Reported Event|Radial Artery|"Radial artery aortocoronary bypass graft~Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery"
10832011|NCT00139477|BG000|Baseline|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
10832012|NCT00139477|BG001|Baseline|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
10832013|NCT00139477|BG002|Baseline|Total|Total of all reporting groups
10832014|NCT00139477|FG000|Participant Flow|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
10832015|NCT00139477|FG001|Participant Flow|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
10832016|NCT00139477|OG000|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
10832017|NCT00139477|OG001|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
10832018|NCT00139477|OG002|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
10832019|NCT00139477|OG003|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
10832020|NCT00139477|EG000|Reported Event|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
10832021|NCT00139477|EG001|Reported Event|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
10832022|NCT00139659|BG000|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832023|NCT00139659|BG001|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832024|NCT00139659|BG002|Baseline|Total|Total of all reporting groups
10832025|NCT00139659|FG000|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832026|NCT00139659|FG001|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832027|NCT00139659|OG000|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832028|NCT00139659|OG001|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832029|NCT00139659|OG000|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832030|NCT00139659|OG001|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832031|NCT00139659|OG000|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832032|NCT00139659|OG001|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832033|NCT00139659|EG000|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
10832034|NCT00139659|EG001|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
10832035|NCT00139737|BG000|Baseline|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
10832036|NCT00139737|FG000|Participant Flow|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
10832037|NCT00139737|OG000|Outcome|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
10832038|NCT00139737|EG000|Reported Event|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
10832039|NCT00139776|BG000|Baseline|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
10832040|NCT00139776|BG001|Baseline|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
10832041|NCT00139776|BG002|Baseline|Total|Total of all reporting groups
10832042|NCT00139776|FG000|Participant Flow|Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories|Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
10832043|NCT00139776|FG001|Participant Flow|Open-Label Celecoxib Run-in Period|Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
10832044|NCT00139776|FG002|Participant Flow|Celecoxib 200mg Continuous Use|Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
10832045|NCT00139776|FG003|Participant Flow|Celecoxib 200mg Intermittent Use|Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
10832046|NCT00139776|OG000|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
10832047|NCT00139776|OG001|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
10832048|NCT00139776|OG000|Outcome|Celecoxib 200mg Open Label|Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
10832049|NCT00139776|EG000|Reported Event|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
10832050|NCT00139776|EG001|Reported Event|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
10832051|NCT00139997|BG000|Baseline|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
10832052|NCT00139997|BG001|Baseline|Inactive Intervention|Equivalent exposure to inactive negative ion generator
10832053|NCT00139997|BG002|Baseline|Total|Total of all reporting groups
10832054|NCT00139997|FG000|Participant Flow|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
10832055|NCT00139997|FG001|Participant Flow|Inactive Intervention|Equivalent exposure to inactive negative ion generator
10832056|NCT00139997|OG000|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
10832057|NCT00139997|OG001|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
10832058|NCT00139997|EG000|Reported Event|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
10832059|NCT00139997|EG001|Reported Event|Inactive Intervention|Equivalent exposure to inactive negative ion generator
10832060|NCT00140140|BG000|Baseline|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
10832061|NCT00140140|BG001|Baseline|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832062|NCT00140140|BG002|Baseline|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832063|NCT00140140|BG003|Baseline|Total|Total of all reporting groups
10832064|NCT00140140|FG000|Participant Flow|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
10832065|NCT00140140|FG001|Participant Flow|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832066|NCT00140140|FG002|Participant Flow|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832067|NCT00140140|OG000|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
10832068|NCT00140140|OG001|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832069|NCT00140140|OG002|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
10832070|NCT00140140|EG000|Reported Event|80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined.
10832071|NCT00140140|EG001|Reported Event|90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2.
10832072|NCT00140205|BG000|Baseline|LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses|5 lean men were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
10832073|NCT00140205|BG001|Baseline|OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses|5 obese men were fasted for 72 hrs and during that period recieved 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
10832074|NCT00140205|BG002|Baseline|OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses|5 lean women were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
10832075|NCT00140205|BG003|Baseline|Total|Total of all reporting groups
10832076|NCT00140205|FG000|Participant Flow|5 LEAN MEN Fasting State (72 Hrs) on 0.3mg/kg Leptin|5 lean men were fasted for 72 hrs and during that period recieved 0.3mg/kg leptin
10832077|NCT00140205|FG001|Participant Flow|5 OBESE MEN 72 HR FASTING on 0.3mg/kg Leptin|5 obese men were fasted for 72 hrs and during that period received 0.3mg/kg leptin
10832078|NCT00140205|FG002|Participant Flow|5 LEAN WOMEN 72 HR FATSING on 0.3mg/kg Leptin|5 lean women were fasted for 72 hrs and during that period received 0.3mg/kg leptin
10832079|NCT00140205|OG000|Outcome|5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg|
10832080|NCT00140205|OG001|Outcome|5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg|
10832081|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg|
10832082|NCT00140205|OG000|Outcome|5 LEAN MEN Fasting State (72 Hrs)|
10832083|NCT00140205|OG001|Outcome|5 OBESE MEN 72 HR FASTING|
10832084|NCT00140205|OG002|Outcome|5 LEAN WOMEN 72 HR FATSING|
10832085|NCT00140205|OG000|Outcome|5 LEAN MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg|
10832086|NCT00140205|OG001|Outcome|5 OBESE MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg|
10832087|NCT00140205|OG002|Outcome|5 LEAN WOMEN (72 Hrs) Fasting - Leptin 0.1 mg/kg|
10832088|NCT00140205|OG000|Outcome|5 LEAN MEN Fasting State (72 Hrs) - Leptin 0.1 mg/kg|
10832089|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.1 mg/kg|
10832090|NCT00140205|OG000|Outcome|5 LEAN MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg|
10832091|NCT00140205|OG001|Outcome|5 OBESE MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg|
10832092|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.3 mg/kg|
10832093|NCT00140205|OG000|Outcome|5 LEAN MEN Fed (24 Hrs) - Leptin 0.3 mg/kg|
10832094|NCT00140205|OG001|Outcome|5 OBESE MEN Fed (24 Hrs) - Leptin 0.3 mg/kg|
10832095|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.3 mg/kg|
10832096|NCT00140205|OG000|Outcome|5 LEAN MEN Fed (24 Hrs) - Leptin 0.01 mg/kg|
10832097|NCT00140205|OG001|Outcome|5 OBESE MEN Fed (24 Hrs) - Leptin 0.01 mg/kg|
10832098|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.01 mg/kg|
10832099|NCT00140205|OG000|Outcome|5 LEAN MEN Fed (24 Hrs) - Leptin 0.1 mg/kg|
10832100|NCT00140205|OG001|Outcome|5 OBESE MEN Fed (24 Hrs) - Leptin 0.1 mg/kg|
10832101|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.1 mg/kg|
10832102|NCT00140205|OG000|Outcome|5 LEAN MEN Fed (24h) or Fasting (72 Hrs)|
10832103|NCT00140205|OG001|Outcome|5 OBESE MEN Fed (24h) or Fasting (72 Hrs)|
10832104|NCT00140205|OG002|Outcome|5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)|
10832105|NCT00140205|EG000|Reported Event|Fasting State (72 Hrs)|
10832106|NCT00140231|BG000|Baseline|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
10832107|NCT00140231|BG001|Baseline|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
10832108|NCT00140231|BG002|Baseline|Total|Total of all reporting groups
10832109|NCT00140231|FG000|Participant Flow|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"Six young, healthy, and lean women (age, 22.8,; BMI,21.7kg/m2) who were eumenor- rheic were enrolled in a clinical researchcenter- based, randomized, cross-over interventional study involving three separate 5-day-long inpatient admissions (22). Six subjects with a cross-over design, enabling paired comparisons, would provide 80% power to detect a difference of 1.4 SD between different conditionsat the conventional~a=0.05 level. In thefirst admission, the subjects were studied in the isocaloric fed state, whereas in the following two admissions the subjects were studied in the prolonged fasting state for 72 h and were randomized to receive either placebo or metreleptin at replacement doses. A cross-over to the opposite arm took place in the later admission so that all six subjects received both placebo and metreleptin.~r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
10832110|NCT00140231|FG001|Participant Flow|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
10832111|NCT00140231|OG000|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
10832112|NCT00140231|OG001|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
10832113|NCT00140231|EG000|Reported Event|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
10832114|NCT00140231|EG001|Reported Event|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
10832115|NCT00140244|BG000|Baseline|All Study Participants|"r-MetHuLeptin SubQ once daily~r-metHuLeptin/placebo then placebo/r-metHuLeptin"
10832116|NCT00140244|FG000|Participant Flow|r-MetHuLeptin First, Then Placebo|r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
10832117|NCT00140244|FG001|Participant Flow|Placebo First, Then r-metHuLeptin|Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
10832118|NCT00140244|OG000|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
10832119|NCT00140244|OG001|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
10832120|NCT00140244|OG000|Outcome|r-metHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
10832121|NCT00140244|EG000|Reported Event|r-MetHuLeptin|
10832122|NCT00140244|EG001|Reported Event|Placebo|
10832123|NCT00140413|BG000|Baseline|Treatment Group 1A: Assigned to GH|Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care.
10832124|NCT00140413|BG001|Baseline|Treatment Group 1B: Randomized to GH|Subjects with normal growth were randomized to GH treatment or to control (no intervention).
10832125|NCT00140413|BG002|Baseline|Treatment Group 2: Control|Subjects with normal growth were randomized to treatment or to control (no intervention).
10832126|NCT00140413|BG003|Baseline|Total|Total of all reporting groups
10832127|NCT00140413|FG000|Participant Flow|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject's stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
10832128|NCT00140413|FG001|Participant Flow|Treatment Group 2: Control|Treatment group assignment was based on subject's stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however, control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
10832129|NCT00140413|OG000|Outcome|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject's stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting daily dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
10832130|NCT00140413|OG001|Outcome|Treatment Group 2: Control|"Treatment group assignment was based on subject's stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.~A total of 7 subjects were randomized to the control group, 3 of whom were crossed over to treatment due to growth deceleration. Outcome measures for these 3 who crossed over were analyzed separately, under Treatment Group 3."
11328367|NCT03426995|OG006|Outcome|Part A: GSK3358699 30 mg SD|Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
10832131|NCT00140413|OG002|Outcome|Treatment Group 3: Control Crossed Over to Treatment|3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
10832132|NCT00140413|EG000|Reported Event|Treatment Group 1: Receiving Growth Hormone Treatment|The denominator below (# at risk) is based on the number of subjects in Group 1 who received at least one dose of growth hormone.
10832133|NCT00140413|EG001|Reported Event|Treatment Group 2: Control|The denominator below (# at risk) is based on the number of subjects in Group 2 who received at least one dose of growth hormone. Per protocol, control subjects received no intervention; however, 3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
10832134|NCT00140426|BG000|Baseline|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
10832135|NCT00140426|BG001|Baseline|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832136|NCT00140426|BG002|Baseline|Total|Total of all reporting groups
10832137|NCT00140426|FG000|Participant Flow|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
10832138|NCT00140426|FG001|Participant Flow|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832139|NCT00140426|OG000|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
10832140|NCT00140426|OG001|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832141|NCT00140426|OG000|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. This is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
11328368|NCT03426995|OG007|Outcome|Part A: GSK3358699 40 mg SD|Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
10832142|NCT00140426|OG001|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication.~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832143|NCT00140426|OG000|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~This subject group received placebo tablets which appeared identical to risperidone"
10832144|NCT00140426|OG001|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832145|NCT00140426|OG000|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
10832146|NCT00140426|EG000|Reported Event|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
10832147|NCT00140426|EG001|Reported Event|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
10832148|NCT00140556|BG000|Baseline|Entire Study Population|
10832149|NCT00140556|FG000|Participant Flow|Entire Study Population|
10832150|NCT00140556|OG000|Outcome|Entire Study Population|
10832151|NCT00140556|EG000|Reported Event|Entire Study Population|
10832152|NCT00140621|BG000|Baseline|Agalsidase Beta|Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
10832153|NCT00140621|FG000|Participant Flow|Agalsidase Beta (Fabrazyme [Recombinant Form])|Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
10832154|NCT00140621|OG000|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
10832155|NCT00140621|EG000|Reported Event|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
10832156|NCT00140842|BG000|Baseline|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
10832157|NCT00140842|BG001|Baseline|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
10832158|NCT00140842|BG002|Baseline|Total|Total of all reporting groups
10832159|NCT00140842|FG000|Participant Flow|Normal-weight Girls|Normal weight girls 12-18 years old
10832160|NCT00140842|FG001|Participant Flow|Obese Girls|Obese adolescents between 12-18 years old.
10832161|NCT00140842|OG000|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
10832162|NCT00140842|OG001|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
10832163|NCT00140842|EG000|Reported Event|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
10832164|NCT00140842|EG001|Reported Event|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
10832165|NCT00140855|BG000|Baseline|Ipilimumab|Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
10832166|NCT00140855|FG000|Participant Flow|Ipilimumab|Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
10832167|NCT00140855|OG000|Outcome|Ipilimumab|Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
10832168|NCT00140855|EG000|Reported Event|Ipilimumab|Three doses of ipilimumab 3 mg/kg, were administered by intravenous infusion at 3 week intervals. A 6-week observation period followed the final dose.
10832169|NCT00141037|BG000|Baseline|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832170|NCT00141037|BG001|Baseline|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832171|NCT00141037|BG002|Baseline|Total|Total of all reporting groups
10832172|NCT00141037|FG000|Participant Flow|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10842790|NCT00249496|EG000|Reported Event|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
10832173|NCT00141037|FG001|Participant Flow|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832174|NCT00141037|OG000|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832175|NCT00141037|OG001|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832176|NCT00141037|EG000|Reported Event|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832177|NCT00141037|EG001|Reported Event|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
10832178|NCT00141102|BG000|Baseline|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
10832179|NCT00141102|BG001|Baseline|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
10832180|NCT00141102|BG002|Baseline|Total|Total of all reporting groups
10832181|NCT00141102|FG000|Participant Flow|Celecoxib|200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
10832182|NCT00141102|FG001|Participant Flow|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
10832183|NCT00141102|OG000|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
10832184|NCT00141102|OG001|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
10832185|NCT00141102|OG001|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
10832186|NCT00141102|EG000|Reported Event|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
10832187|NCT00141102|EG001|Reported Event|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
10832188|NCT00141115|BG000|Baseline|Levetiracetam|Levetiracetam 1500 mg BID
10832189|NCT00141115|FG000|Participant Flow|Levetiracetam|Levetiracetam 1500 mg BID
10832190|NCT00141115|OG000|Outcome|Levetiracetam 1500 mg Twice Daily|Levitiracetam 1500 mg administered twice daily under open-label conditions.
10832191|NCT00141115|OG000|Outcome|Levetiracetam|"Levetiracetam 1500 mg BID~levetiracetam: Levetiracetam 1500 mg BID"
10832192|NCT00141115|EG000|Reported Event|Levetiracetam 1500 mg Twice Daily|Levitiracetam 1500 mg administered twice daily under open label conditions.
10832193|NCT00141219|BG000|Baseline|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
10832194|NCT00141219|BG001|Baseline|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
10832195|NCT00141219|BG002|Baseline|Total|Total of all reporting groups
10832196|NCT00141219|FG000|Participant Flow|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
10832197|NCT00141219|FG001|Participant Flow|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
10832198|NCT00141219|OG000|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
10832199|NCT00141219|OG001|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
11095854|NCT01560416|BG000|Baseline|ARM A - Fulvestrant|Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.
11095855|NCT01560416|BG001|Baseline|Arm B - Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression."
11095856|NCT01560416|BG002|Baseline|Total|Total of all reporting groups
11095857|NCT01560416|FG000|Participant Flow|ARM A - Fulvestrant|Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.
11095858|NCT01560416|FG001|Participant Flow|Arm B - Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression."
11095859|NCT01560416|OG000|Outcome|ARM A - Fulvestrant|Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.
11095860|NCT01560416|OG001|Outcome|Arm B - Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression."
11095861|NCT01560416|OG002|Outcome|Arm A - Crossover Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression."
11095862|NCT01560416|EG000|Reported Event|ARM A - Fulvestrant|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days~Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression."
11095863|NCT01560416|EG001|Reported Event|Arm B - Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression."
11095864|NCT01560416|EG002|Reported Event|Arm A - Crossover Fulvestrant+Ganetespib|"Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle~Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression."
11095865|NCT01560429|BG000|Baseline|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095866|NCT01560429|BG001|Baseline|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095867|NCT01560429|BG002|Baseline|Total|Total of all reporting groups
11095868|NCT01560429|FG000|Participant Flow|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
11095869|NCT01560429|FG001|Participant Flow|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
11328369|NCT03426995|OG000|Outcome|Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11095870|NCT01560429|OG000|Outcome|Patient-controlled Epidural Analgesia|An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
11095871|NCT01560429|OG001|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
11095872|NCT01560429|OG000|Outcome|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095873|NCT01560429|OG001|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095874|NCT01560429|EG000|Reported Event|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095875|NCT01560429|EG001|Reported Event|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
11095876|NCT01560624|BG000|Baseline|UT-15C|"Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg TID~Treprostinil Diolamine: Active"
11095877|NCT01560624|BG001|Baseline|Placebo|"Matching placebo tablets (oral)~Placebo: Placebo"
11095878|NCT01560624|BG002|Baseline|Total|Total of all reporting groups
11095879|NCT01560624|FG000|Participant Flow|UT-15C|"Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg three times daily (TID)~Treprostinil Diolamine: Active"
11095880|NCT01560624|FG001|Participant Flow|Placebo|"Matching placebo tablets (oral)~Placebo: Placebo"
11095881|NCT01560624|OG000|Outcome|UT-15C|"Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg TID~Treprostinil Diolamine: Active"
11095882|NCT01560624|OG001|Outcome|Placebo|"Matching placebo tablets (oral)~Placebo: Placebo"
11095883|NCT01560624|EG000|Reported Event|UT-15C|"Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg TID~Treprostinil Diolamine: Active"
11095884|NCT01560624|EG001|Reported Event|Placebo|"Matching placebo tablets (oral)~Placebo: Placebo"
11095885|NCT01560780|BG000|Baseline|Arm 1: Prasugrel|"prasugrel 10 mg by mouth daily~Prasugrel: one 10 mg tablet by mouth daily"
11095886|NCT01560780|BG001|Baseline|Arm 2: Placebo|"placebo by mouth once daily~Placebo: placebo similar in appearance to prasugrel"
11095887|NCT01560780|BG002|Baseline|Total|Total of all reporting groups
11095888|NCT01560780|FG000|Participant Flow|Arm 1: Prasugrel|"prasugrel 10 mg by mouth daily~Prasugrel: one 10 mg tablet by mouth daily"
11095889|NCT01560780|FG001|Participant Flow|Arm 2: Placebo|"placebo by mouth once daily~Placebo: placebo similar in appearance to prasugrel"
11095890|NCT01560780|OG000|Outcome|Arm 1: Prasugrel|"prasugrel 10 mg by mouth daily~Prasugrel: one 10 mg tablet by mouth daily"
11095891|NCT01560780|OG001|Outcome|Arm 2: Placebo|"placebo by mouth once daily~Placebo: placebo similar in appearance to prasugrel"
11095892|NCT01560780|EG000|Reported Event|Arm 1: Prasugrel|"prasugrel 10 mg by mouth daily~Prasugrel: one 10 mg tablet by mouth daily"
11095893|NCT01560780|EG001|Reported Event|Arm 2: Placebo|"placebo by mouth once daily~Placebo: placebo similar in appearance to prasugrel"
11095894|NCT01560819|BG000|Baseline|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
11095895|NCT01560819|BG001|Baseline|Donors|Healthy donors (>18 years of age) were chosen by participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
11095896|NCT01560819|BG002|Baseline|Total|Total of all reporting groups
11095897|NCT01560819|FG000|Participant Flow|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
11095898|NCT01560819|FG001|Participant Flow|Donors|Healthy donors (>18 years of age) were chosen by the participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
11328370|NCT03426995|OG001|Outcome|Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11095899|NCT01560819|OG000|Outcome|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate ulcerative colitis (UC) (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
11095900|NCT01560819|EG000|Reported Event|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
11095901|NCT01560871|BG000|Baseline|Low-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks.~Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr"
11095902|NCT01560871|BG001|Baseline|High-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of six weeks.~High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat har"
11095903|NCT01560871|BG002|Baseline|Total|Total of all reporting groups
11095904|NCT01560871|FG000|Participant Flow|Low-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program consists of walking daily at an intensity of somewhat hard to hard on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day, then progress to 45-50 minutes a day by six weeks.~Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr"
11095905|NCT01560871|FG001|Participant Flow|High-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking daily at an intensity of somewhat hard to hard on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by six weeks.~High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat har"
11095906|NCT01560871|OG000|Outcome|Low-intensity IMT Plus Walking|"For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered Sham training..~The walking program consisted of walking at an intensity of hard to somewhat hard on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate.~The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device."
11218025|NCT02318602|OG001|Outcome|Children|"Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11328371|NCT03426995|OG000|Outcome|Part C: Cohort 4 and 5- Placebo RD|Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
10832200|NCT00141219|EG000|Reported Event|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
10832201|NCT00141219|EG001|Reported Event|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
10832202|NCT00141271|BG000|Baseline|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
10832203|NCT00141271|BG001|Baseline|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
10832204|NCT00141271|BG002|Baseline|Placebo|Subjects were assigned to placebo
10832205|NCT00141271|BG003|Baseline|Total|Total of all reporting groups
10832206|NCT00141271|FG000|Participant Flow|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
10832207|NCT00141271|FG001|Participant Flow|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
10832208|NCT00141271|FG002|Participant Flow|Placebo|Subjects were assigned to placebo
10832209|NCT00141271|OG000|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
10832210|NCT00141271|OG001|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
10832211|NCT00141271|OG002|Outcome|Placebo|Subjects were assigned to placebo
10832212|NCT00141271|EG000|Reported Event|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
10832213|NCT00141271|EG001|Reported Event|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
10832214|NCT00141271|EG002|Reported Event|Placebo|Subjects were assigned to placebo
10832215|NCT00141297|BG000|Baseline|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832216|NCT00141297|BG001|Baseline|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832217|NCT00141297|BG002|Baseline|Total|Total of all reporting groups
10832218|NCT00141297|FG000|Participant Flow|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832219|NCT00141297|FG001|Participant Flow|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832220|NCT00141297|FG002|Participant Flow|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832221|NCT00141297|FG003|Participant Flow|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832222|NCT00141297|FG004|Participant Flow|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832223|NCT00141297|FG005|Participant Flow|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832224|NCT00141297|FG006|Participant Flow|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832225|NCT00141297|FG007|Participant Flow|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832226|NCT00141297|FG008|Participant Flow|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832227|NCT00141297|FG009|Participant Flow|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832228|NCT00141297|OG000|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
11336157|NCT03562481|BG000|Baseline|Sequence 1: Unbuffered Anesthetic, Then Buffered Anesthetic|Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine.
11336158|NCT03562481|BG001|Baseline|Sequence 2: Buffered Anesthetic, Then Unbuffered Anesthetic|Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.
11336159|NCT03562481|BG002|Baseline|Total|Total of all reporting groups
11336160|NCT03562481|FG000|Participant Flow|Sequence 1: Unbuffered Anesthetic, Then Buffered Anesthetic|Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. 1% After one week minimum washout period, subjects will then receive an injection with Buffered Lidocaine 1:100,000 Epinephrine.
11336161|NCT03562481|FG001|Participant Flow|Sequence 2: Buffered Anesthetic, Then Unbuffered Anesthetic|Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.
11336162|NCT03562481|OG000|Outcome|Buffered Anesthetic|"Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.~1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique."
11336163|NCT03562481|OG001|Outcome|Unbuffered Anesthetic|"Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.~2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique."
11336164|NCT03562481|OG000|Outcome|Buffered Anesthetic|"Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.~1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique."
11336165|NCT03562481|OG001|Outcome|Unbuffered Anesthetic|"Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine.~2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique."
11336166|NCT03562481|OG000|Outcome|Buffered Anesthetic|1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
11336167|NCT03562481|OG001|Outcome|Unbuffered Anesthetic|2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
11336168|NCT03562481|EG000|Reported Event|Buffered Anesthetic|1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
11336169|NCT03562481|EG001|Reported Event|Unbuffered Anesthetic|2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
11336170|NCT03562559|BG000|Baseline|TKA Patients|Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
11336171|NCT03562559|FG000|Participant Flow|TKA Patients|Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
11336172|NCT03562559|OG000|Outcome|TKA Patients|Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
11336173|NCT03562559|EG000|Reported Event|TKA Patients|Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
11336174|NCT03562663|BG000|Baseline|Active tDCS|"Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention.~Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11095907|NCT01560871|OG001|Outcome|High-intensity IMT Plus Walking|"For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.~The walking program consisted of walking at an intensity of hard to somewhat hard on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate.~Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured.."
11095908|NCT01560871|OG001|Outcome|High-intensity IMT Plus Walking|"For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.~The walking program was the same as the one for the control group.~Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured.."
11095909|NCT01560871|EG000|Reported Event|Low-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks.~Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr"
11095910|NCT01560871|EG001|Reported Event|High-intensity IMT Plus Walking|"Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking every day at an intensity of hard to somewhat hard on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of six weeks.~High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.~For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of hard to somewhat har"
11095911|NCT01560923|BG000|Baseline|Control (Placebo) Arm|"Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth."
11095912|NCT01560923|BG001|Baseline|Treatment|"Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday)."
11095913|NCT01560923|BG002|Baseline|Total|Total of all reporting groups
11095914|NCT01560923|FG000|Participant Flow|Sipuleucel-T + Placebo|"Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth."
11095915|NCT01560923|FG001|Participant Flow|Sipuleucel-T + Oral Indoximod|"Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday)."
11095916|NCT01560923|OG000|Outcome|Sipuleucel-T + Placebo|"Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth."
11095917|NCT01560923|OG001|Outcome|Sipuleucel-T + Oral Indoximod|"Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday)."
11328372|NCT03426995|OG001|Outcome|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
10832229|NCT00141297|OG001|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832230|NCT00141297|OG002|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832231|NCT00141297|OG003|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832232|NCT00141297|OG004|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832233|NCT00141297|OG005|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832234|NCT00141297|OG006|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832235|NCT00141297|OG007|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832236|NCT00141297|OG008|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832237|NCT00141297|OG009|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832238|NCT00141297|OG000|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832239|NCT00141297|OG001|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832240|NCT00141297|OG003|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832241|NCT00141297|OG005|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832242|NCT00141297|OG006|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832243|NCT00141297|OG007|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832244|NCT00141297|OG003|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832245|NCT00141297|OG000|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832246|NCT00141297|OG003|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832247|NCT00141297|OG000|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832248|NCT00141297|OG001|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832249|NCT00141297|EG000|Reported Event|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832250|NCT00141297|EG001|Reported Event|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832251|NCT00141297|EG002|Reported Event|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832252|NCT00141297|EG003|Reported Event|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832253|NCT00141297|EG004|Reported Event|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832254|NCT00141297|EG005|Reported Event|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832255|NCT00141297|EG006|Reported Event|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832256|NCT00141297|EG007|Reported Event|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832257|NCT00141297|EG008|Reported Event|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832258|NCT00141297|EG009|Reported Event|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
10832259|NCT00141453|BG000|Baseline|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
10832260|NCT00141453|BG001|Baseline|Placebo Comparator|Matching placebo tablets
10832261|NCT00141453|BG002|Baseline|Total|Total of all reporting groups
10832262|NCT00141453|FG000|Participant Flow|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
10832263|NCT00141453|FG001|Participant Flow|Placebo Comparator|Matching placebo tablets
10832264|NCT00141453|OG000|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
10832265|NCT00141453|OG001|Outcome|Placebo Comparator|Matching placebo tablets
10832266|NCT00141453|EG000|Reported Event|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
10832267|NCT00141453|EG001|Reported Event|Placebo Comparator|Matching placebo tablets
10832268|NCT00141518|BG000|Baseline|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832269|NCT00141518|BG001|Baseline|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832270|NCT00141518|BG002|Baseline|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832271|NCT00141518|BG003|Baseline|Total|Total of all reporting groups
10832272|NCT00141518|FG000|Participant Flow|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832273|NCT00141518|FG001|Participant Flow|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
11095918|NCT01560923|EG000|Reported Event|Sipuleucel-T + Indoximod|"Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday)."
10832274|NCT00141518|FG002|Participant Flow|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832275|NCT00141518|OG000|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832276|NCT00141518|OG001|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832277|NCT00141518|OG002|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832278|NCT00141518|OG003|Outcome|Total|All participants
10832279|NCT00141518|OG000|Outcome|Total|Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for < 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832280|NCT00141518|EG000|Reported Event|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832281|NCT00141518|EG001|Reported Event|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832282|NCT00141518|EG002|Reported Event|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
10832283|NCT00141726|BG000|Baseline|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
10832284|NCT00141726|FG000|Participant Flow|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
10832285|NCT00141726|OG000|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
10832286|NCT00141726|EG000|Reported Event|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
10832287|NCT00141739|BG000|Baseline|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
10832288|NCT00141739|FG000|Participant Flow|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
10832289|NCT00141739|OG000|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
10832290|NCT00141739|OG000|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
10832291|NCT00141739|OG001|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
11328373|NCT03426995|OG002|Outcome|Part C: Cohort 6- GSK3358699 or Placebo RD|Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
10832292|NCT00141739|EG000|Reported Event|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
10832293|NCT00141765|BG000|Baseline|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
10832294|NCT00141765|FG000|Participant Flow|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
10832295|NCT00141765|OG000|Outcome|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
10832296|NCT00141765|EG000|Reported Event|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
10832297|NCT00141778|BG000|Baseline|Placebo|Placebo Group
10832298|NCT00141778|BG001|Baseline|Ramipril|Angiotensin-converting enzyme inhibitor group
10832299|NCT00141778|BG002|Baseline|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
10832300|NCT00141778|BG003|Baseline|Total|Total of all reporting groups
10832301|NCT00141778|FG000|Participant Flow|Placebo|Placebo Group
10832302|NCT00141778|FG001|Participant Flow|Ramipril|Angiotensin-Converting Enzyme Inhibitor Group. Ramipril was given as 2.5 mg the first 3 days followed by 5 mg/day, with the dose reduced to 2.5 mg/day on the first postoperative day only.
10832303|NCT00141778|FG002|Participant Flow|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist Group.Spironolactone was given as 25 mg/day.
10832304|NCT00141778|OG000|Outcome|Placebo|Placebo Group
10832305|NCT00141778|OG001|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
10832306|NCT00141778|OG002|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
10832307|NCT00141778|EG000|Reported Event|Placebo|Placebo Group
10832308|NCT00141778|EG001|Reported Event|Ramipril|Angiotensin-converting enzyme inhibitor group
10832309|NCT00141778|EG002|Reported Event|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
10832310|NCT00141817|BG000|Baseline|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
10832311|NCT00141817|BG001|Baseline|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
10832312|NCT00141817|BG002|Baseline|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
10832313|NCT00141817|BG003|Baseline|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
10832314|NCT00141817|BG004|Baseline|Total|Total of all reporting groups
10832315|NCT00141817|FG000|Participant Flow|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
10832316|NCT00141817|FG001|Participant Flow|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
10832317|NCT00141817|FG002|Participant Flow|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
10832318|NCT00141817|FG003|Participant Flow|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
10832319|NCT00141817|OG000|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
10832320|NCT00141817|OG001|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
10832321|NCT00141817|OG002|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
10832322|NCT00141817|OG003|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
10832323|NCT00141817|EG000|Reported Event|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
10832324|NCT00141817|EG001|Reported Event|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
10832325|NCT00141817|EG002|Reported Event|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
10832326|NCT00141817|EG003|Reported Event|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
10832327|NCT00141921|BG000|Baseline|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
10832328|NCT00141921|FG000|Participant Flow|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
10832329|NCT00141921|OG000|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
10832330|NCT00141921|EG000|Reported Event|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
10832331|NCT00142116|BG000|Baseline|All WM Patients|Waldenstrom's Macroglobulinemia Patients
10832332|NCT00142116|FG000|Participant Flow|All WM Patients|Waldenstrom's Macroglobulinemia Patients
10832333|NCT00142116|OG000|Outcome|All WM Patients|Waldenstrom's Macroglobulinemia Patients
10832334|NCT00142116|OG000|Outcome|Thalidomide and Rituximab|"Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks~Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.~Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.~Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later."
10832335|NCT00142116|EG000|Reported Event|All WM Patients|Waldenstrom's Macroglobulinemia Patients
10832336|NCT00142168|BG000|Baseline|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
10832337|NCT00142168|FG000|Participant Flow|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
10832338|NCT00142168|OG000|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
10832339|NCT00142168|EG000|Reported Event|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
10832340|NCT00142298|BG000|Baseline|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832341|NCT00142298|BG001|Baseline|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832342|NCT00142298|BG002|Baseline|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832343|NCT00142298|BG003|Baseline|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832344|NCT00142298|BG004|Baseline|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832345|NCT00142298|BG005|Baseline|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832346|NCT00142298|BG006|Baseline|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832347|NCT00142298|BG007|Baseline|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832348|NCT00142298|BG008|Baseline|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832349|NCT00142298|BG009|Baseline|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832350|NCT00142298|BG010|Baseline|Total|Total of all reporting groups
10832351|NCT00142298|FG000|Participant Flow|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832352|NCT00142298|FG001|Participant Flow|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832353|NCT00142298|FG002|Participant Flow|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832354|NCT00142298|FG003|Participant Flow|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832355|NCT00142298|FG004|Participant Flow|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832356|NCT00142298|FG005|Participant Flow|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832357|NCT00142298|FG006|Participant Flow|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
11328374|NCT03426995|OG003|Outcome|Part C: Cohort 7- GSK3358699 or Placebo RD|Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
10832358|NCT00142298|FG007|Participant Flow|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832359|NCT00142298|FG008|Participant Flow|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832360|NCT00142298|FG009|Participant Flow|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832361|NCT00142298|OG000|Outcome|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832362|NCT00142298|OG000|Outcome|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832363|NCT00142298|OG000|Outcome|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832364|NCT00142298|OG001|Outcome|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832365|NCT00142298|OG002|Outcome|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832366|NCT00142298|OG000|Outcome|Group B : LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832367|NCT00142298|OG000|Outcome|Group B : LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832368|NCT00142298|OG000|Outcome|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832369|NCT00142298|OG001|Outcome|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832370|NCT00142298|OG000|Outcome|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832371|NCT00142298|EG000|Reported Event|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832372|NCT00142298|EG001|Reported Event|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832373|NCT00142298|EG002|Reported Event|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832374|NCT00142298|EG003|Reported Event|Group A: Feeder 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832375|NCT00142298|EG004|Reported Event|Group A: Feeder 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832376|NCT00142298|EG005|Reported Event|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
10832377|NCT00142298|EG006|Reported Event|Group B: Lam 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10832378|NCT00142298|EG007|Reported Event|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832379|NCT00142298|EG008|Reported Event|Group C: Lam Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832380|NCT00142298|EG009|Reported Event|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
10832381|NCT00142415|BG000|Baseline|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
10832382|NCT00142415|BG001|Baseline|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
10832383|NCT00142415|BG002|Baseline|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
10832384|NCT00142415|BG003|Baseline|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
10832385|NCT00142415|BG004|Baseline|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
10832386|NCT00142415|BG005|Baseline|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
10832387|NCT00142415|BG006|Baseline|Total|Total of all reporting groups
10832388|NCT00142415|FG000|Participant Flow|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
10832389|NCT00142415|FG001|Participant Flow|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
10832390|NCT00142415|FG002|Participant Flow|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
10832391|NCT00142415|FG003|Participant Flow|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
10832392|NCT00142415|FG004|Participant Flow|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
10832393|NCT00142415|FG005|Participant Flow|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
10832394|NCT00142415|OG000|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
10832395|NCT00142415|OG001|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
10832396|NCT00142415|OG002|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
10832397|NCT00142415|OG003|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
10832398|NCT00142415|OG004|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
10832399|NCT00142415|OG005|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
10832400|NCT00142415|OG000|Outcome|Dosimetry Evaluable Analysis Set|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
10832401|NCT00142415|EG000|Reported Event|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
10832402|NCT00142415|EG001|Reported Event|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
10832403|NCT00142415|EG002|Reported Event|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
10832404|NCT00142415|EG003|Reported Event|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
10832405|NCT00142415|EG004|Reported Event|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
10832406|NCT00142415|EG005|Reported Event|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
10832407|NCT00142415|EG006|Reported Event|Total|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
10832408|NCT00142454|BG000|Baseline|Imiquimod + NY-ESO-1|Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
10832409|NCT00142454|FG000|Participant Flow|Imiquimod + NY-ESO-1|Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
10832410|NCT00142454|OG000|Outcome|Imiquimod + NY-ESO-1|Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
10832411|NCT00142454|EG000|Reported Event|Imiquimod + NY-ESO-1|Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
10832412|NCT00142506|BG000|Baseline|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
11095919|NCT01560923|EG001|Reported Event|Sipuleucel-T + Placebo|"Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth."
11095920|NCT01560949|BG000|Baseline|Systemic Phase: mFOLFIRINOX|Oxaliplatin at 75 mg/m2 IV on day 1, Irinotecan at 150 mg/m2 IV on day 1, 5 fluorouracil at 2000 mg/m2 IV 46 hour continuous infusion on day 1 - 2, every other week for 6 cycles (12 weeks)
11095921|NCT01560949|FG000|Participant Flow|Systemic Phase: mFOLFIRINOX|"Systemic: Oxaliplatin at 75 mg/m2 IV on day 1, Irinotecan at 150 mg/m2 IV on day 1, 5 fluorouracil at 2000 mg/m2 IV 46 hour continuous infusion on day 1 - 2, every other week for 6 cycles (12 weeks).~Chemo: Gemcitabine at 350 mg/m2 IV weekly for 5 doses beginning day 1. External beam radiation therapy delivered 5 days/week, a total dose of 50.4 Gy.~Surgery: At least 4 - 6 weeks after the last dose of Gemcitabine if there is no local progression or distant metastasis"
11095922|NCT01560949|OG000|Outcome|Surgery|At least 4 - 6 weeks after the last dose of Gemcitabine if there is no local progression or distant metastasis.
11095923|NCT01560949|OG000|Outcome|All Phases|Oxalipaltin + irinotecan + 5-fluorouracil, every other week for 6 cycles (12 weeks) followed by gemcitabine weekly for 5 doses with radiation therapy 5 days/week. Then surgery at least 4-6 weeks after the last dose of gemcitabine if no local progression or distant metastasis.
11095924|NCT01560949|OG000|Outcome|All Phases(Systematic,Chemoradiation w/ Gemcitabine & Surgery)|Oxalipaltin + irinotecan + 5-fluorouracil, every other week for 6 cycles (12 weeks) followed by gemcitabine weekly for 5 doses with radiation therapy 5 days/week. Then surgery at least 4-6 weeks after the last dose of gemcitabine if no local progression or distant metastasis.
11095925|NCT01560949|EG000|Reported Event|Systemin Phase: mFOLFIRINOX|Oxalipaltin 75 mg/m2 IV on day 1, irinotecan 150 mg/m2 IV on day 1, 5-fluorouracil 2,000 mg/m2 IV 46 hours continuous infusion, every other week for 6 cycles (12 weeks).
11095926|NCT01560949|EG001|Reported Event|Chemoradiation Phase: Radiation With Gemcitabine|Gemcitabine 350 mg/m2 IV weekly for 5 doses beginning day 1. External beam radiation therapy 5 days/week, a total dose of 50.4 Gy.
11095927|NCT01560949|EG002|Reported Event|Surgery|At least 4-6 weeks after the last dose of gemcitabine if there is no local progression or distant metastasis
11095928|NCT01560975|BG000|Baseline|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
11095929|NCT01560975|FG000|Participant Flow|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
11095930|NCT01560975|OG000|Outcome|POAG/CPAP|POAG patients with CPAP therapy
11095931|NCT01560975|OG001|Outcome|noPOAG/CPAP|Subjects with CPAP
11095932|NCT01560975|OG001|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
11095933|NCT01560975|OG002|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
11095934|NCT01560975|OG003|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
11328375|NCT03426995|OG004|Outcome|Part C: Cohort 8- GSK3358699 or Placebo RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
11095935|NCT01560975|EG000|Reported Event|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
11095936|NCT01560988|BG000|Baseline|All Study Participants|Participants were randomized to receive either borage and echium oils first, and corn oil second, or vice versa
11095937|NCT01560988|FG000|Participant Flow|First Borage and Echium, Then Corn Oil|Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks, followed by a 6 week washout. Then, subjects were crossed over to receive corn oil (10 g) daily for six weeks
11095938|NCT01560988|FG001|Participant Flow|First Corn Oil, Then Borage and Echium Seed Oil|Corn oil pills will be taken for six weeks, followed by a 6 week washout. Then subjects received borage and echium oil tablets for six week.
11095939|NCT01560988|OG000|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
11095940|NCT01560988|OG001|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
11095941|NCT01560988|OG001|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills will be taken three times per day for six weeks."
11095942|NCT01560988|OG000|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks"
11095943|NCT01560988|OG000|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil."
11095944|NCT01560988|OG001|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks"
11095945|NCT01560988|OG000|Outcome|All Study Participants|All study participants, regardless of arm assignment, were genotyped at the LTC4S locus.
11095946|NCT01560988|EG000|Reported Event|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.~Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
11095947|NCT01560988|EG001|Reported Event|Corn Oil Pills|"Corn oil pills will be taken for six weeks.~Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
11095948|NCT01561053|BG000|Baseline|High Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095949|NCT01561053|BG001|Baseline|Low Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095950|NCT01561053|BG002|Baseline|Low Albumin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
11095951|NCT01561053|BG003|Baseline|Control (Sham) Group|Simulated plasma exchange procedure
10832413|NCT00142506|BG001|Baseline|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
10832414|NCT00142506|BG002|Baseline|Total|Total of all reporting groups
10832415|NCT00142506|FG000|Participant Flow|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
10832416|NCT00142506|FG001|Participant Flow|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
10832417|NCT00142506|OG000|Outcome|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
10832418|NCT00142506|OG001|Outcome|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
10832419|NCT00142506|EG000|Reported Event|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
10832420|NCT00142506|EG001|Reported Event|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
11095952|NCT01561053|BG004|Baseline|Total|Total of all reporting groups
11328376|NCT03426995|OG000|Outcome|Part A: GSK3358699 1 mg SD|Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
10832421|NCT00142597|BG000|Baseline|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832422|NCT00142597|BG001|Baseline|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832423|NCT00142597|BG002|Baseline|Total|Total of all reporting groups
10832424|NCT00142597|FG000|Participant Flow|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832425|NCT00142597|FG001|Participant Flow|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832426|NCT00142597|OG000|Outcome|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832427|NCT00142597|OG001|Outcome|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832428|NCT00142597|EG000|Reported Event|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832429|NCT00142597|EG001|Reported Event|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
10832430|NCT00142792|BG000|Baseline|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832431|NCT00142792|BG001|Baseline|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832432|NCT00142792|BG002|Baseline|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832433|NCT00142792|BG003|Baseline|Total|Total of all reporting groups
10832434|NCT00142792|FG000|Participant Flow|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832435|NCT00142792|FG001|Participant Flow|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832436|NCT00142792|FG002|Participant Flow|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832437|NCT00142792|OG000|Outcome|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832438|NCT00142792|OG001|Outcome|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832439|NCT00142792|OG002|Outcome|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832440|NCT00142792|EG000|Reported Event|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832441|NCT00142792|EG001|Reported Event|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832442|NCT00142792|EG002|Reported Event|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
10832443|NCT00142818|BG000|Baseline|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
10832444|NCT00142818|BG001|Baseline|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
10832445|NCT00142818|BG002|Baseline|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
10832446|NCT00142818|BG003|Baseline|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
10832447|NCT00142818|BG004|Baseline|Total|Total of all reporting groups
10832448|NCT00142818|FG000|Participant Flow|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
10832449|NCT00142818|FG001|Participant Flow|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
10832450|NCT00142818|FG002|Participant Flow|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
10832451|NCT00142818|FG003|Participant Flow|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
10832452|NCT00142818|OG000|Outcome|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
10832453|NCT00142818|OG001|Outcome|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
10832454|NCT00142818|OG002|Outcome|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
10832455|NCT00142818|OG003|Outcome|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
10832456|NCT00142818|OG000|Outcome|Modafinil Plus Naltrexone|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
10832457|NCT00142818|OG001|Outcome|Naltrexone|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
10832458|NCT00142818|OG002|Outcome|Modafinil|"Mod~Modafinil: 400 mg daily"
10832459|NCT00142818|OG003|Outcome|Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
10832460|NCT00142818|EG000|Reported Event|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
10832461|NCT00142818|EG001|Reported Event|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
10832462|NCT00142818|EG002|Reported Event|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
10832463|NCT00142818|EG003|Reported Event|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
10832464|NCT00142909|BG000|Baseline|Lofexidine|
10832465|NCT00142909|BG001|Baseline|Placebo|
10832466|NCT00142909|BG002|Baseline|Total|Total of all reporting groups
11095953|NCT01561053|FG000|Participant Flow|High Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
10832467|NCT00142909|FG000|Participant Flow|Lofexidine|"Lofexidine: Study medication~Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject."
10832468|NCT00142909|FG001|Participant Flow|Placebo|Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
10832469|NCT00142909|OG000|Outcome|Lofexidine|Lofexidine: Study medication
10832470|NCT00142909|OG001|Outcome|Placebo|Placebo pill
10832471|NCT00142909|EG000|Reported Event|Lofexidine|Lofexidine: Study medication
10832472|NCT00142909|EG001|Reported Event|Placebo|Placebo pill
10832473|NCT00142935|BG000|Baseline|Pre-release MMT Initiation + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
10832474|NCT00142935|BG001|Baseline|MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
10832475|NCT00142935|BG002|Baseline|MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
10832476|NCT00142935|BG003|Baseline|Total|Total of all reporting groups
10832477|NCT00142935|FG000|Participant Flow|Pre-release MMT Initiation + Referral Post Release + Payment|Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
10832478|NCT00142935|FG001|Participant Flow|MMT Referral Post Release + Payment|Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
10832479|NCT00142935|FG002|Participant Flow|MMT Referral Post Release|Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
10832480|NCT00142935|OG000|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
10832481|NCT00142935|OG001|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
10832482|NCT00142935|OG002|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
10832483|NCT00142935|OG000|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
10832484|NCT00142935|OG001|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
10832485|NCT00142935|OG002|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
10832486|NCT00142935|OG000|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
10832487|NCT00142935|EG000|Reported Event|As Assigned: Pre-release MMT + Referral Post Release + Payment|"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews."
10832488|NCT00142935|EG001|Reported Event|As Assigned: MMT Referral Post Release + Payment|"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews."
10832489|NCT00142935|EG002|Reported Event|As Assigned: MMT Referral Post Release|"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.~Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews."
10832490|NCT00143247|BG000|Baseline|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject's weight, any previous responses to insulin, and other factors noted in the protocol.
10832491|NCT00143247|FG000|Participant Flow|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject's weight, any previous responses to insulin, and other factors noted in the protocol.
10832492|NCT00143247|OG000|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject's weight, any previous responses to insulin, and other factors noted in the protocol.
10832493|NCT00143247|EG000|Reported Event|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject's weight, any previous responses to insulin, and other factors noted in the protocol.
10832494|NCT00143312|BG000|Baseline|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
10832495|NCT00143312|FG000|Participant Flow|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
10832496|NCT00143312|OG000|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
10832497|NCT00143312|EG000|Reported Event|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
10832498|NCT00143390|BG000|Baseline|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832499|NCT00143390|BG001|Baseline|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832500|NCT00143390|BG002|Baseline|Total|Total of all reporting groups
10832501|NCT00143390|FG000|Participant Flow|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832502|NCT00143390|FG001|Participant Flow|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832503|NCT00143390|OG000|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832504|NCT00143390|OG001|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832505|NCT00143390|EG000|Reported Event|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832506|NCT00143390|EG001|Reported Event|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
10832507|NCT00143403|BG000|Baseline|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832508|NCT00143403|BG001|Baseline|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832509|NCT00143403|BG002|Baseline|Total|Total of all reporting groups
10832510|NCT00143403|FG000|Participant Flow|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832511|NCT00143403|FG001|Participant Flow|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832512|NCT00143403|OG000|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832513|NCT00143403|OG001|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832514|NCT00143403|EG000|Reported Event|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832515|NCT00143403|EG001|Reported Event|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
10832516|NCT00143455|BG000|Baseline|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
11328377|NCT03426995|OG001|Outcome|Part A: GSK3358699 3 mg SD|Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
10832517|NCT00143455|BG001|Baseline|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832518|NCT00143455|BG002|Baseline|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832519|NCT00143455|BG003|Baseline|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832520|NCT00143455|BG004|Baseline|Total|Total of all reporting groups
10832521|NCT00143455|FG000|Participant Flow|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832522|NCT00143455|FG001|Participant Flow|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832523|NCT00143455|FG002|Participant Flow|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832524|NCT00143455|FG003|Participant Flow|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832525|NCT00143455|OG000|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832526|NCT00143455|OG001|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832527|NCT00143455|OG002|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832528|NCT00143455|OG003|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832529|NCT00143455|OG000|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832530|NCT00143455|OG001|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832531|NCT00143455|EG000|Reported Event|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832532|NCT00143455|EG001|Reported Event|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832533|NCT00143455|EG002|Reported Event|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832534|NCT00143455|EG003|Reported Event|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
10832535|NCT00143507|BG000|Baseline|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
10832536|NCT00143507|BG001|Baseline|Placebo|Patients received placebo twice daily.
10832537|NCT00143507|BG002|Baseline|Total|Total of all reporting groups
10832538|NCT00143507|FG000|Participant Flow|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
10832539|NCT00143507|FG001|Participant Flow|Placebo|Patients received placebo twice daily.
10832540|NCT00143507|OG000|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
10832541|NCT00143507|OG001|Outcome|Placebo|Patients received placebo twice daily.
10832542|NCT00143507|EG000|Reported Event|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
10832543|NCT00143507|EG001|Reported Event|Placebo|Patients received placebo twice daily.
10832544|NCT00143598|BG000|Baseline|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
10832545|NCT00143598|BG001|Baseline|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
10832546|NCT00143598|BG002|Baseline|Total|Total of all reporting groups
10832547|NCT00143598|FG000|Participant Flow|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
10832548|NCT00143598|FG001|Participant Flow|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
10832549|NCT00143598|OG000|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
10832550|NCT00143598|OG001|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
10832551|NCT00143598|EG000|Reported Event|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
10832552|NCT00143598|EG001|Reported Event|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
10832553|NCT00143819|BG000|Baseline|Bilateral Comparison Group 1|"bilateral comparison~Neuroskin Forte: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
10832554|NCT00143819|BG001|Baseline|Bilateral Comparison Group 2|"bilateral comparison~Placebo Application: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
10832555|NCT00143819|BG002|Baseline|Total|Total of all reporting groups
10832556|NCT00143819|FG000|Participant Flow|1 (Left Side: Active; Right Side: Placebo)|"bilateral comparison~Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
10832557|NCT00143819|FG001|Participant Flow|2 (Left Side: Placebo; Right Side: Active)|"bilateral comparison~Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
10832558|NCT00143819|OG000|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
10832559|NCT00143819|OG001|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
10832560|NCT00143819|OG000|Outcome|Neuroskin Forte Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
10832561|NCT00143819|OG001|Outcome|Placebo Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
10832562|NCT00143819|OG000|Outcome|Neuroskin Forte Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
10832563|NCT00143819|OG001|Outcome|Placebo Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
10832564|NCT00143819|OG001|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
10832565|NCT00143819|EG000|Reported Event|Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks."
10832566|NCT00143845|BG000|Baseline|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
10832567|NCT00143845|FG000|Participant Flow|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
10832568|NCT00143845|OG000|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
10832569|NCT00143845|EG000|Reported Event|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
10832570|NCT00144027|BG000|Baseline|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
10832571|NCT00144027|BG001|Baseline|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
10832572|NCT00144027|BG002|Baseline|Total|Total of all reporting groups
10832573|NCT00144027|FG000|Participant Flow|Control|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
11095954|NCT01561053|FG001|Participant Flow|Low Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
10832574|NCT00144027|FG001|Participant Flow|Antipsychotic Adherence Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
10832575|NCT00144027|OG000|Outcome|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
10832576|NCT00144027|OG001|Outcome|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
10832577|NCT00144027|EG000|Reported Event|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
10832578|NCT00144027|EG001|Reported Event|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
10832579|NCT00144170|BG000|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|
10832580|NCT00144170|BG001|Baseline|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
10832581|NCT00144170|BG002|Baseline|Total|Total of all reporting groups
10832582|NCT00144170|FG000|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|
10832583|NCT00144170|FG001|Participant Flow|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
10832584|NCT00144170|OG000|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
10832585|NCT00144170|OG001|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
10832586|NCT00144170|EG000|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|
10832587|NCT00144170|EG001|Reported Event|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
10832588|NCT00144300|BG000|Baseline|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
10832589|NCT00144300|BG001|Baseline|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
10832590|NCT00144300|BG002|Baseline|Total|Total of all reporting groups
10832591|NCT00144300|FG000|Participant Flow|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
10832592|NCT00144300|FG001|Participant Flow|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
10832593|NCT00144300|OG000|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
10832594|NCT00144300|OG001|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
10832595|NCT00144300|EG000|Reported Event|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
10832596|NCT00144300|EG001|Reported Event|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
10832597|NCT00144339|BG000|Baseline|Placebo|Once daily
10832598|NCT00144339|BG001|Baseline|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
10832599|NCT00144339|BG002|Baseline|Total|Total of all reporting groups
10832600|NCT00144339|FG000|Participant Flow|Placebo|once daily
10832601|NCT00144339|FG001|Participant Flow|Tiotropium Bromide Inhalation Capsules 18 mcg|once daily
10832602|NCT00144339|OG000|Outcome|Placebo|Once daily
10832603|NCT00144339|OG001|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
10832604|NCT00144339|EG000|Reported Event|Placebo|Once daily
10832605|NCT00144339|EG001|Reported Event|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
10832606|NCT00144391|BG000|Baseline|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832607|NCT00144391|BG001|Baseline|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832608|NCT00144391|BG002|Baseline|Total|Total of all reporting groups
10832609|NCT00144391|FG000|Participant Flow|Transdermal Testosterone Gel|Transdermal Testosterone gel- 2.0 mg per pump dose 2 pumps per thigh per day for 6 months
10832610|NCT00144391|FG001|Participant Flow|Placebo|"Placebo~placebo gel- 2 pumps per thigh per day for 6 months"
10832611|NCT00144391|OG000|Outcome|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832612|NCT00144391|OG001|Outcome|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832613|NCT00144391|EG000|Reported Event|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832614|NCT00144391|EG001|Reported Event|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
10832615|NCT00144781|BG000|Baseline|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
10832616|NCT00144781|BG001|Baseline|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
10832617|NCT00144781|BG002|Baseline|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832618|NCT00144781|BG003|Baseline|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832619|NCT00144781|BG004|Baseline|Total|Total of all reporting groups
10832620|NCT00144781|FG000|Participant Flow|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
10832621|NCT00144781|FG001|Participant Flow|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
10832622|NCT00144781|FG002|Participant Flow|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832623|NCT00144781|FG003|Participant Flow|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832624|NCT00144781|OG000|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
10832625|NCT00144781|OG001|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
10832626|NCT00144781|OG002|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832627|NCT00144781|OG003|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
10832628|NCT00144781|EG000|Reported Event|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Description***"
10832629|NCT00144781|EG001|Reported Event|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Description***"
10832630|NCT00144781|EG002|Reported Event|"Aldurazyme|Weekly|0.58 mg/kg***Check Title***"|"Aldurazyme|Weekly|0.58 mg/kg***Check Description***"
10832631|NCT00144781|EG003|Reported Event|"Aldurazyme|Weekly|1.2 mg/kg***Check Title***"|"Aldurazyme|Weekly|1.2 mg/kg***Check Description***"
10832632|NCT00144963|BG000|Baseline|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
10832633|NCT00144963|FG000|Participant Flow|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
10832634|NCT00144963|OG000|Outcome|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
10832635|NCT00144963|EG000|Reported Event|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
10832636|NCT00145041|BG000|Baseline|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
10832637|NCT00145041|FG000|Participant Flow|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
10832638|NCT00145041|OG000|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
10832639|NCT00145041|EG000|Reported Event|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
10832640|NCT00145119|BG000|Baseline|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
10832641|NCT00145119|FG000|Participant Flow|Patients|
10832642|NCT00145119|OG000|Outcome|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
10832643|NCT00145119|EG000|Reported Event|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
10832644|NCT00145145|BG000|Baseline|MAGE-3.A1 Peptide Mixed With CpG 7909|Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
10832645|NCT00145145|FG000|Participant Flow|MAGE-3.A1 Peptide Mixed With CpG 7909|Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
10832646|NCT00145145|OG000|Outcome|MAGE-3.A1 Peptide Mixed With CpG 7909|Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
11095955|NCT01561053|FG002|Participant Flow|Low Albumin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
11095956|NCT01561053|FG003|Participant Flow|Control (Sham) Group|Simulated plasma exchange procedure
10832647|NCT00145145|EG000|Reported Event|MAGE-3.A1 Peptide Mixed With CpG 7909|Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
10832648|NCT00145249|BG000|Baseline|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
10832649|NCT00145249|BG001|Baseline|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
10832650|NCT00145249|BG002|Baseline|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
10832651|NCT00145249|BG003|Baseline|Total|Total of all reporting groups
10832652|NCT00145249|FG000|Participant Flow|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
10832653|NCT00145249|FG001|Participant Flow|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
10832654|NCT00145249|FG002|Participant Flow|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
10832655|NCT00145249|OG000|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
10832656|NCT00145249|OG001|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
10832657|NCT00145249|OG002|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
10832658|NCT00145249|EG000|Reported Event|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
10832659|NCT00145249|EG001|Reported Event|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
10832660|NCT00145249|EG002|Reported Event|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
10842791|NCT00249496|EG001|Reported Event|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
10842792|NCT00249613|BG000|Baseline|Women-Only Treatment 152 Subjects|Out-patient gender-responsive substance abuse treatment for women only
10842793|NCT00249613|BG001|Baseline|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment for women and men
10842794|NCT00249613|BG002|Baseline|Total|Total of all reporting groups
10842795|NCT00249613|FG000|Participant Flow|Women-Only Treatment 152 Subjects|Out patient gender-responsive substance abuse treatment for women only
10842796|NCT00249613|FG001|Participant Flow|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment that included both women and men
10842797|NCT00249613|OG000|Outcome|Women-Only|"Substance abuse treatment program for women only~Women-Only: Gender-responsive treatment for women only"
10842798|NCT00249613|OG001|Outcome|Mixed-Gender|Substance abuse treatment program for both women and men
10842799|NCT00249613|OG000|Outcome|Women-Only Compared to Mixed-Gender|Outpatient gender-responsive substance abuse treatment for women only compared to outpatient substance abuse treatment for women and men
10842800|NCT00249613|OG000|Outcome|Group Status (Women-Only Compared to Mixed-Gender)|Outpatient gender-responsive substance abuse treatment for women only vs. outpatient mixed-gender substance abuse treatment
10842801|NCT00249613|OG000|Outcome|Group Status (Women-Only Compared to Mixed-Gender|Comparison of outcome in Women-Only vs. Mixed-Gender treatment
10842802|NCT00249613|EG000|Reported Event|Women-Only|Outpatient gender-responsive substance abuse treatment for women only
10842803|NCT00249613|EG001|Reported Event|Mixed-Gender|Outpatient mixed-gender substance abuse treatment
10842804|NCT00249769|BG000|Baseline|LJEV Then MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
10842805|NCT00249769|BG001|Baseline|LJEV and MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
10842806|NCT00249769|BG002|Baseline|MV Then LJEV|Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
10842807|NCT00249769|BG003|Baseline|Total|Total of all reporting groups
10842808|NCT00249769|FG000|Participant Flow|LJEV Then MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
10842809|NCT00249769|FG001|Participant Flow|LJEV and MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
10842810|NCT00249769|FG002|Participant Flow|MV Then LJEV|Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
10832661|NCT00145327|BG000|Baseline|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
10832662|NCT00145327|BG001|Baseline|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
10832663|NCT00145327|BG002|Baseline|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
10832664|NCT00145327|BG003|Baseline|Total|Total of all reporting groups
10832665|NCT00145327|FG000|Participant Flow|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
10832666|NCT00145327|FG001|Participant Flow|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
10832667|NCT00145327|FG002|Participant Flow|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
10832668|NCT00145327|OG000|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
10832669|NCT00145327|OG001|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
10832670|NCT00145327|OG002|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
10832671|NCT00145327|EG000|Reported Event|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
10832672|NCT00145327|EG001|Reported Event|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
10832673|NCT00145327|EG002|Reported Event|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
10832674|NCT00145418|BG000|Baseline|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
10832675|NCT00145418|FG000|Participant Flow|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
10832676|NCT00145418|OG000|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
10832677|NCT00145418|EG000|Reported Event|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
10832678|NCT00145574|BG000|Baseline|Placebo|Placebo similar to active
10832679|NCT00145574|BG001|Baseline|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
10832680|NCT00145574|BG002|Baseline|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
10832681|NCT00145574|BG003|Baseline|Total|Total of all reporting groups
10832682|NCT00145574|FG000|Participant Flow|Placebo|Placebo similar to active
10832683|NCT00145574|FG001|Participant Flow|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
10832684|NCT00145574|FG002|Participant Flow|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
10832685|NCT00145574|OG000|Outcome|Placebo|Placebo similar to active
10832686|NCT00145574|OG001|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
10832687|NCT00145574|OG002|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
10832688|NCT00145574|OG000|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
10832689|NCT00145574|OG001|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
10832690|NCT00145574|OG002|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
10832691|NCT00145574|OG003|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
10832692|NCT00145574|EG000|Reported Event|Placebo Double Blind Period|Placebo taken from day 1 to week 8.
10832693|NCT00145574|EG001|Reported Event|Low Dose Colesevelam Double Blind Period|Low dose colesevelam 1.9 grams per day taken from day 1 to week 8.
10832694|NCT00145574|EG002|Reported Event|High Dose Colesevelam Double Blind Period|High dose colesevelam 3.8 grams per day taken from day 1 to week 8.
10832695|NCT00145574|EG003|Reported Event|High Dose Colesevelam Open Label Extension|All participants of the Open Label Extension (weeks 8-26) took colesevelam 3.8 grams per day.
10832696|NCT00145587|BG000|Baseline|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
10832697|NCT00145587|BG001|Baseline|Sibling|Genetic testing
10832698|NCT00145587|BG002|Baseline|Total|Total of all reporting groups
10832699|NCT00145587|FG000|Participant Flow|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
10832700|NCT00145587|FG001|Participant Flow|Sibling|Genetic testing
10832701|NCT00145587|OG000|Outcome|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
10832702|NCT00145587|OG001|Outcome|Sibling|Genetic testing
10832703|NCT00145587|EG000|Reported Event|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
10832704|NCT00145587|EG001|Reported Event|Sibling|Genetic testing
10832705|NCT00145626|BG000|Baseline|Alive|"Group of participants who survived to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832706|NCT00145626|BG001|Baseline|Expired|"Those participants who did not survive to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832707|NCT00145626|BG002|Baseline|Total|Total of all reporting groups
10832708|NCT00145626|FG000|Participant Flow|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832709|NCT00145626|OG000|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832710|NCT00145626|OG000|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832711|NCT00145626|OG000|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
10832712|NCT00145626|OG001|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
10832713|NCT00145626|OG002|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832714|NCT00145626|OG002|Outcome|Study Participants|"MRD data were collected on four study participants. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832715|NCT00145626|OG000|Outcome|Study Participants: Before HSCT|All study participants as previously described.
10832716|NCT00145626|OG001|Outcome|Study Participants: 1 Year Post HSCT|All study participants as previously described.
10832717|NCT00145626|OG002|Outcome|Study Participants: 5 Years Post HSCT|All study participants as previously described.
10832718|NCT00145626|OG000|Outcome|0-3 Months After HSCT|Study participants as previously described.
10832719|NCT00145626|OG001|Outcome|3-6 Months After HSCT|Study participants as previously described.
10832720|NCT00145626|OG002|Outcome|6-9 Months After HSCT|Study participants as previously described.
10832721|NCT00145626|OG003|Outcome|9-12 Months After HSCT|Study participants as previously described.
10832722|NCT00145626|OG004|Outcome|1-2 Years After HSCT|Study participants as previously described.
10832723|NCT00145626|OG005|Outcome|2-3 Years After HSCT|Study participants as previously described.
10832724|NCT00145626|OG006|Outcome|3-4 Years After HSCT|Study participants as previously described.
10832725|NCT00145626|OG007|Outcome|4-5 Years After HSCT|Study participants as previously described.
10832726|NCT00145626|EG000|Reported Event|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
10832727|NCT00145977|BG000|Baseline|Alendronate|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.~Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations."
11095957|NCT01561053|OG000|Outcome|High Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095958|NCT01561053|OG001|Outcome|Low Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095959|NCT01561053|OG002|Outcome|Low Albumin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
11095960|NCT01561053|OG003|Outcome|Control (Sham) Group|Simulated plasma exchange procedure
11095961|NCT01561053|OG004|Outcome|All Treated|All patients Treatment groups 1, 2 and 3 combined
11095962|NCT01561053|EG000|Reported Event|High Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095963|NCT01561053|EG001|Reported Event|Low Albumin + Immunoglobulin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
11095964|NCT01561053|EG002|Reported Event|Low Albumin|Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
11095965|NCT01561053|EG003|Reported Event|Control (Sham) Group|Simulated plasma exchange procedure
11095966|NCT01561079|BG000|Baseline|Fetal|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects completing any maternal-fetal monitoring at any combination of the following gestational ages: 24, 28, 32 36 weeks
11095967|NCT01561079|FG000|Participant Flow|Maternal Buprenorphine Treatment|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects undergo maternal-fetal monitoring at any combination of the following gestational time periods: 24, 28,32, 36 weeks of gestation
11095968|NCT01561079|OG000|Outcome|FHR 24 Weeks Trough|Fetal heart rate in beats per minute at 24 weeks of gestation at trough
11095969|NCT01561079|OG001|Outcome|FHR 28 Weeks Trough|Fetal heart rate in beats per minute at 28 weeks of gestation at time of trough maternal buprenorphine level
11095970|NCT01561079|OG002|Outcome|FHR 32 Weeks Trough|Fetal heart rate in beats per minute at 32 weeks of gestation at time of trough maternal buprenorphine level
11095971|NCT01561079|OG003|Outcome|FHR 36 Weeks Trough|Fetal heart rate in beats per minute at 36 weeks of gestation at time of trough maternal buprenorphine level
11095972|NCT01561079|OG004|Outcome|FHR 24 Weeks Peak|Fetal heart rate in beats per minute at 24 weeks of gestation at time of peak maternal buprenorphine level
11095973|NCT01561079|OG005|Outcome|FHR 28 Weeks Peak|Fetal heart rate in beats per minute at 28 weeks of gestation at time of peak maternal buprenorphine level
11095974|NCT01561079|OG006|Outcome|FHR 32 Peak|Fetal heart rate in beats per minute at 32 weeks of gestation at time of peak maternal buprenorphine level
11095975|NCT01561079|OG007|Outcome|FHR 36 Peak|Fetal heart rate in beats per minute at 36 weeks of gestation at time of peak maternal buprenorphine level
11095976|NCT01561079|OG000|Outcome|FHRV 24 Trough|Fetal heart rate variability at 24 weeks of gestation at time of trough maternal buprenorphine level
11095977|NCT01561079|OG001|Outcome|FHRV 28 Trough|Fetal heart rate variability at 28 weeks of gestation at time of trough maternal buprenorphine level
11095978|NCT01561079|OG002|Outcome|FHRV 32 Trough|Fetal heart rate variability at 32 weeks of gestation at time of trough maternal buprenorphine level
11095979|NCT01561079|OG003|Outcome|FHRV 36 Trough|Fetal heart rate variability at 36 weeks of gestation at time of trough maternal buprenorphine level
11095980|NCT01561079|OG004|Outcome|FHRV 24 Peak|Fetal heart rate variability at 24 weeks gestation at the time of peak maternal buprenorphine levels
11095981|NCT01561079|OG005|Outcome|FHRV 28 Peak|Fetal heart rate variability at 28 weeks gestation at the time of peak maternal buprenorphine levels
11095982|NCT01561079|OG006|Outcome|FHRV 32 Peak|Fetal heart rate variability at 32 weeks gestation at the time of peak maternal buprenorphine levels
11095983|NCT01561079|OG007|Outcome|FHRV 36 Peak|Fetal heart rate variability at 36 weeks gestation at the time of peak maternal buprenorphine levels
11095984|NCT01561079|OG000|Outcome|Accelerations 24 Trough|Accelerations in fetal heart rate at 24 weeks of gestation at time of trough maternal buprenorphine level
11095985|NCT01561079|OG001|Outcome|Accelerations 28 Trough|Accelerations in fetal heart rate at 28 weeks of gestation at time of trough maternal buprenorphine level
11095986|NCT01561079|OG002|Outcome|Accelerations 32 Trough|Accelerations in fetal heart rate at 32 weeks of gestation at time of trough maternal buprenorphine level
11095987|NCT01561079|OG003|Outcome|Accelerations 36 Trough|Accelerations in fetal heart rate at 36 weeks of gestation at time of trough maternal buprenorphine level
11095988|NCT01561079|OG004|Outcome|Accelerations 24 Peak|Accelerations in fetal heart rate at 24 weeks of gestation at time of peak maternal buprenorphine level
11095989|NCT01561079|OG005|Outcome|Accelerations 28 Peak|Accelerations in fetal heart rate at 28 weeks of gestation at time of peak maternal buprenorphine level
11095990|NCT01561079|OG006|Outcome|Accelerations 32 Peak|Accelerations in fetal heart rate at 32 weeks of gestation at time of peak maternal buprenorphine level
11095991|NCT01561079|OG007|Outcome|Accelerations36 Peak|Accelerations in fetal heart rate at 36 weeks of gestation at time of peak maternal buprenorphine level
11095992|NCT01561079|OG000|Outcome|Fetal Movement 24 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11095993|NCT01561079|OG001|Outcome|Fetal Movement 28 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11095994|NCT01561079|OG002|Outcome|Fetal Movement 32 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11095995|NCT01561079|OG003|Outcome|Fetal Movement 36 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11095996|NCT01561079|OG004|Outcome|Fetal Movement 24 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
10832728|NCT00145977|BG001|Baseline|Control|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.~Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal."
10832729|NCT00145977|BG002|Baseline|Total|Total of all reporting groups
10832730|NCT00145977|FG000|Participant Flow|Alendronate|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.~Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations."
10832731|NCT00145977|FG001|Participant Flow|Control|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.~Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal."
10832732|NCT00145977|OG000|Outcome|Alendronate|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.~Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations."
10832733|NCT00145977|OG001|Outcome|Control|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.~Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal."
10832734|NCT00145977|EG000|Reported Event|Alendronate|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.~Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations."
10832735|NCT00145977|EG001|Reported Event|Control|"All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.~Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal."
10832736|NCT00146172|BG000|Baseline|Neratinib 40 mg|Neratinb 40 mg qd
10832737|NCT00146172|BG001|Baseline|Neratinib 80 mg|Neratinib 80 mg qd
10832738|NCT00146172|BG002|Baseline|Neratinib 120 mg|Neratinib 120 mg qd
10832739|NCT00146172|BG003|Baseline|Neratinib 180 mg|Neratinib 180 mg qd
10832740|NCT00146172|BG004|Baseline|Neratinib 240 mg|Neratinib 240 mg qd
10832741|NCT00146172|BG005|Baseline|Neratinib 320 mg|Neratinib 320 mg qd
10832742|NCT00146172|BG006|Baseline|Neratinib 400 mg|Neratinib 400 mg qd
10832743|NCT00146172|BG007|Baseline|Neratinib MTD|Neratinib maximum tolerated dose (320 mg) from part 2.
10832744|NCT00146172|BG008|Baseline|Total|Total of all reporting groups
10832745|NCT00146172|FG000|Participant Flow|Neratinib 40 mg|Neratinb 40 mg qd
10832746|NCT00146172|FG001|Participant Flow|Neratinib 80 mg|Neratinib 80 mg qd
10832747|NCT00146172|FG002|Participant Flow|Neratinib 120 mg|Neratinib 120 mg qd
10832748|NCT00146172|FG003|Participant Flow|Neratinib 180 mg|Neratinib 180 mg qd
10832749|NCT00146172|FG004|Participant Flow|Neratinib 240 mg|Neratinib 240 mg qd
10832750|NCT00146172|FG005|Participant Flow|Neratinib 320 mg|Neratinib 320 mg qd
10832751|NCT00146172|FG006|Participant Flow|Neratinib 400 mg|Neratinib 400 mg qd
10832752|NCT00146172|FG007|Participant Flow|Neratinib MTD|Neratinib maximum tolerated dose (320 mg).
10832753|NCT00146172|OG000|Outcome|Neratinib 40 mg|Neratinb 40 mg qd
10832754|NCT00146172|OG001|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
10832755|NCT00146172|OG002|Outcome|Neratinib 120 mg|Neratinib 120 mg qd
10832756|NCT00146172|OG003|Outcome|Neratinib 180 mg|Neratinib 180 mg qd
10832757|NCT00146172|OG004|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
10832758|NCT00146172|OG005|Outcome|Neratinib 320 mg|Neratinib 320 mg qd.
10832759|NCT00146172|OG006|Outcome|Neratinib 400 mg|Neratinib 400 mg qd
11095997|NCT01561079|OG005|Outcome|Fetal Movement 28 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
10832760|NCT00146172|OG000|Outcome|Breast Cancer Cohort|Subjects with Breast Cancer
10832761|NCT00146172|OG001|Outcome|Lung Cancer Cohort|Subjects with Lung Cancer
10832762|NCT00146172|OG002|Outcome|All Subjects|Subjects with Cancer
10832763|NCT00146172|OG000|Outcome|Breast Cancer|Subjects with Breast Cancer
10832764|NCT00146172|OG001|Outcome|Lung Cancer|Subjects with Lung Cancer
10832765|NCT00146172|OG000|Outcome|Breast Cancer|Subjects with breast cancer in all doses of neratinib
10832766|NCT00146172|OG001|Outcome|Lung Cancer|Subjects with Lung cancer in all doses of Neratinib
10832767|NCT00146172|OG002|Outcome|All Solid Tumors|Subjects with solid tumors in all doses of Neratinib
10832768|NCT00146172|OG000|Outcome|Neratinib 320 mg|Neratinib 320 mg qd
10832769|NCT00146172|EG000|Reported Event|Neratinib 40 mg|Neratinb 40 mg qd
10832770|NCT00146172|EG001|Reported Event|Neratinib 80 mg|Neratinib 80 mg qd
10832771|NCT00146172|EG002|Reported Event|Neratinib 120 mg|Neratinib 120 mg qd
10832772|NCT00146172|EG003|Reported Event|Neratinib 180 mg|Neratinib 180 mg qd
10832773|NCT00146172|EG004|Reported Event|Neratinib 240 mg|Neratinib 240 mg qd
10832774|NCT00146172|EG005|Reported Event|Neratinib 320 mg|Neratinib 320 mg qd
10832775|NCT00146172|EG006|Reported Event|Neratinib 400 mg|Neratinib 400 mg qd
10832776|NCT00146172|EG007|Reported Event|Neratinib MTD|Neratinib maximum tolerated dose (320 mg).
10842811|NCT00249769|OG000|Outcome|LJEV Then MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
11095998|NCT01561079|OG006|Outcome|Fetal Movement 32 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
10832777|NCT00146328|BG000|Baseline|Group 1 (Patients With Varying Degrees of Treatment Experience|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
10832778|NCT00146328|BG001|Baseline|Group 2 (Highly Treatment Experienced Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
10832779|NCT00146328|BG002|Baseline|Group 3 (Tipranavir naïve Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
10832780|NCT00146328|BG003|Baseline|Total|Total of all reporting groups
10832781|NCT00146328|FG000|Participant Flow|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
10832782|NCT00146328|FG001|Participant Flow|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
10832783|NCT00146328|FG002|Participant Flow|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
10832784|NCT00146328|OG000|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
10832785|NCT00146328|OG001|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
10832786|NCT00146328|OG002|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
10832787|NCT00146328|EG000|Reported Event|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
10832788|NCT00146328|EG001|Reported Event|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
10832789|NCT00146328|EG002|Reported Event|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
10832790|NCT00146640|BG000|Baseline|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
10832791|NCT00146640|BG001|Baseline|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
10832792|NCT00146640|BG002|Baseline|Total|Total of all reporting groups
10832793|NCT00146640|FG000|Participant Flow|MR Prednisone|Participants received tablets containing modified-release (MR) prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time and placebo matching to immediate-release (IR) prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
10832794|NCT00146640|FG001|Participant Flow|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
10832795|NCT00146640|OG000|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
10832796|NCT00146640|OG001|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
10832797|NCT00146640|EG000|Reported Event|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
10832798|NCT00146640|EG001|Reported Event|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
10832799|NCT00146757|BG000|Baseline|Arms 1 and 2 Combined|
10832800|NCT00146757|FG000|Participant Flow|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
10832801|NCT00146757|FG001|Participant Flow|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
10842812|NCT00249769|OG001|Outcome|LJEV and MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
10832802|NCT00146757|OG000|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks - labeled dose.
10832803|NCT00146757|OG001|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient's urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
10832804|NCT00146757|OG000|Outcome|Arms 1 and 2 Combined|
10832805|NCT00146757|EG000|Reported Event|Aldurazyme ***Check Title***|Aldurazyme ***check title***
10832806|NCT00146770|BG000|Baseline|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
10832807|NCT00146770|BG001|Baseline|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
10832808|NCT00146770|BG002|Baseline|Total|Total of all reporting groups
10832809|NCT00146770|FG000|Participant Flow|Placebo/Aldurazyme|"Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. Baseline for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study."
10832810|NCT00146770|FG001|Participant Flow|Aldurazyme/Aldurazyme|"Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. Baseline for this group is the last measurement prior to randomization in the Double-Blind Study."
10832811|NCT00146770|OG000|Outcome|Placebo/Aldurazyme|"Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. Baseline for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study."
10832812|NCT00146770|OG001|Outcome|Aldurazyme/Aldurazyme|"Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. Baseline for this group is the last measurement prior to randomization in the Double-Blind Study."
10832813|NCT00146770|EG000|Reported Event|"Placebo/|Aldurazyme***Check Title***"|"Placebo/|Aldurazyme***Check Description***"
10832814|NCT00146770|EG001|Reported Event|"Aldurazyme/|Aldurazyme***Check Title***"|"Aldurazyme/|Aldurazyme***Check Description***"
10832815|NCT00146848|BG000|Baseline|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
10832816|NCT00146848|BG001|Baseline|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
10832817|NCT00146848|BG002|Baseline|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
10832818|NCT00146848|BG003|Baseline|Total|Total of all reporting groups
10832819|NCT00146848|FG000|Participant Flow|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
10832820|NCT00146848|FG001|Participant Flow|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
10832821|NCT00146848|FG002|Participant Flow|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
10832822|NCT00146848|OG000|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
10832823|NCT00146848|OG001|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
10832824|NCT00146848|OG002|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
10832825|NCT00146848|EG000|Reported Event|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
10832826|NCT00146848|EG001|Reported Event|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
10832827|NCT00146848|EG002|Reported Event|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
10832828|NCT00147017|BG000|Baseline|Smokers|All subjects had a smoking history of >15 pack years
10832829|NCT00147017|BG001|Baseline|Ex-smokers|Ex-smokers had ceased smoking for >6 months.
10832830|NCT00147017|BG002|Baseline|Emphysema Lung Transplant|The emphysema subjects were all undergoing lung transplants.
10832831|NCT00147017|BG003|Baseline|Total|Total of all reporting groups
10832832|NCT00147017|FG000|Participant Flow|Smokers|All subjects had a smoking history of >15 pack years
10832833|NCT00147017|FG001|Participant Flow|Ex-smokers|Ex-smokers had ceased smoking for >6 months.
10832834|NCT00147017|FG002|Participant Flow|Emphysema Lung Transplant|The emphysema subjects were all undergoing lung transplants.
10832835|NCT00147017|OG000|Outcome|Smokers|All subjects had a smoking history of >15 pack years
10832836|NCT00147017|OG001|Outcome|Ex-smokers|Ex-smokers had ceased smoking for >6 months.
10832837|NCT00147017|OG002|Outcome|Emphysema Lung Transplant|The emphysema subjects were all undergoing lung transplants.
10832838|NCT00147017|EG000|Reported Event|Smokers|All subjects had a smoking history of >15 pack years
10832839|NCT00147017|EG001|Reported Event|Ex-smokers|Ex-smokers had ceased smoking for >6 months.
10832840|NCT00147017|EG002|Reported Event|Emphysema Lung Transplant|The emphysema subjects were all undergoing lung transplants.
10832841|NCT00147030|BG000|Baseline|Cooled|Whole body mild induced hypothermia 72 hours, commencing by 6 hours of age followed by re-warming to normothermia.
10832842|NCT00147030|BG001|Baseline|Non-cooled|Standard intensive care
10832843|NCT00147030|BG002|Baseline|Total|Total of all reporting groups
10832844|NCT00147030|FG000|Participant Flow|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
10832845|NCT00147030|FG001|Participant Flow|Non-cooled|Standard intensive care at normothermia
10832846|NCT00147030|OG000|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
10832847|NCT00147030|OG001|Outcome|Non-cooled|Standard intensive care
10832848|NCT00147030|OG000|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
10832849|NCT00147030|OG000|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
10832850|NCT00147030|EG000|Reported Event|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
10832851|NCT00147030|EG001|Reported Event|Non-cooled|Standard intensive care
10832852|NCT00147043|BG000|Baseline|Autologous Stem Cells|Male or female aged from 20 years to 65 years with evidence of chronic liver failure, abnormal serum albumin and/or bilirubin and/or prothrombin time
10832853|NCT00147043|FG000|Participant Flow|Autologous Stem Cells|Pre-treatment with Granulocyte-Colony Stimulating Factor (G-CSF) to mobilise CD34+ cells Leukapheresis procedure to extract mobilised CD34+ cells Cultured CD34+ cells administered via hepatic artery of portal vein
10832854|NCT00147043|OG000|Outcome|Autologous Stem Cells|Male of Female participants aged from 20-65 years old with chronic liver failure Abnormal liver function Abnormal serum albumin and/or bilirubin and/or prothrombin time Unsuitable for liver transplantation WHO Performance status <2 Women of childbearing potential may be included but must use a reliable and appropriate contraceptive method Life expectancy of at least 3 monthsAbility to give informed consent
10832855|NCT00147043|OG000|Outcome|Autologous Stem Cells|"Leukapheresis~Infusion of stem cells via image guided scan"
10832856|NCT00147043|EG000|Reported Event|Autologous Stem Cells|Male of Female participants aged from 20-65 years old with chronic liver failure, abnormal liver function, abnormal serum albumin and/or bilirubin and/or prothrombin time
10832857|NCT00147069|BG000|Baseline|Controls|Non-smoking control subjects without lung disease
10832858|NCT00147069|BG001|Baseline|Asthmatics|Non-smokers patients with asthma
10832859|NCT00147069|BG002|Baseline|Non-COPD Smokers|Current smokers without airways obstruction, FEV1 >80% predicted
10832860|NCT00147069|BG003|Baseline|COPD Smokers|Patients with COPD and cigarette smokers
10832861|NCT00147069|BG004|Baseline|Total|Total of all reporting groups
10832862|NCT00147069|FG000|Participant Flow|Controls|Non-smoking control subjects without lung disease
10832863|NCT00147069|FG001|Participant Flow|Asthmatics|Non-smokers patients with asthma
10832864|NCT00147069|FG002|Participant Flow|Non-COPD Smokers|Current smokers without airways obstruction, FEV1 >80% predicted
11095999|NCT01561079|OG007|Outcome|Fetal Movement 36 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
10832865|NCT00147069|FG003|Participant Flow|COPD Smokers|Patients with COPD and cigarette smokers
10832866|NCT00147069|OG000|Outcome|Controls|Non-smoking control subjects without lung disease
10832867|NCT00147069|OG001|Outcome|Asthmatics|Non-smokers patients with asthma
10832868|NCT00147069|OG002|Outcome|Non-COPD Smokers|Current smokers without airways obstruction, FEV1 >80% predicted
10832869|NCT00147069|OG003|Outcome|COPD Smokers|Patients with COPD and cigarette smokers
10832870|NCT00147069|EG000|Reported Event|Controls|Non-smoking control subjects without lung disease
10832871|NCT00147069|EG001|Reported Event|Asthmatics|Non-smokers patients with asthma
10832872|NCT00147069|EG002|Reported Event|Non-COPD Smokers|Current smokers without airways obstruction, FEV1 >80% predicted
10832873|NCT00147069|EG003|Reported Event|COPD Smokers|Patients with COPD and cigarette smokers
10832874|NCT00147082|BG000|Baseline|COPD|Patients with COPD - no intervention
10832875|NCT00147082|BG001|Baseline|Smokers Without COPD|Smokers without COPD - no intervention
10832876|NCT00147082|BG002|Baseline|Non-smokers|Non-smokers with no history of respiratory disease - no intervention
10832877|NCT00147082|BG003|Baseline|Total|Total of all reporting groups
10832878|NCT00147082|FG000|Participant Flow|COPD|Patients with COPD - no intervention
10832879|NCT00147082|FG001|Participant Flow|Smokers Without COPD|Smokers without COPD - no intervention
10832880|NCT00147082|FG002|Participant Flow|Non-smokers|Non-smokers with no history of respiratory disease - no intervention
10832881|NCT00147082|OG000|Outcome|COPD|Patients with COPD - no intervention
10832882|NCT00147082|OG001|Outcome|Smokers Without COPD|Smokers without COPD - no intervention
10832883|NCT00147082|OG002|Outcome|Non-smokers|Non-smokers with no history of respiratory disease - no intervention
10832884|NCT00147082|EG000|Reported Event|COPD|Patients with COPD - no intervention
10832885|NCT00147082|EG001|Reported Event|Smokers Without COPD|Smokers without COPD - no intervention
10832886|NCT00147082|EG002|Reported Event|Non-smokers|Non-smokers with no history of respiratory disease - no intervention
10832887|NCT00147199|BG000|Baseline|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
10832888|NCT00147199|BG001|Baseline|Placebo|Identical placebo inhalation solution
10832889|NCT00147199|BG002|Baseline|Total|Total of all reporting groups
10832890|NCT00147199|FG000|Participant Flow|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
10832891|NCT00147199|FG001|Participant Flow|Placebo|Identical placebo inhalation solution
10832892|NCT00147199|OG000|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
10832893|NCT00147199|OG001|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
10832894|NCT00147199|EG000|Reported Event|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
10832895|NCT00147199|EG001|Reported Event|Placebo|Identical placebo inhalation solution
11096000|NCT01561079|OG000|Outcome|FM-FHR 24 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
10832896|NCT00147212|BG000|Baseline|Trabectedin|Experimental arm treated with trabectedin (ET-743)
10832897|NCT00147212|FG000|Participant Flow|Trabectedin|Experimental arm treated with trabectedin (ET-743)
10832898|NCT00147212|OG000|Outcome|Trabectedin|Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
10832899|NCT00147212|EG000|Reported Event|Trabectedin|Experimental arm treated with trabectedin (ET-743)
10832900|NCT00147225|BG000|Baseline|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832901|NCT00147225|BG001|Baseline|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832902|NCT00147225|BG002|Baseline|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832903|NCT00147225|BG003|Baseline|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
10832904|NCT00147225|BG004|Baseline|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832905|NCT00147225|BG005|Baseline|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832906|NCT00147225|BG006|Baseline|Total|Total of all reporting groups
10832907|NCT00147225|FG000|Participant Flow|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~Adriamycin /Ifosfamide (AI) regimens [Adriamycin (Doxorubicin) 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2"
10832908|NCT00147225|FG001|Participant Flow|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
10832909|NCT00147225|FG002|Participant Flow|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
10832910|NCT00147225|FG003|Participant Flow|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
10832911|NCT00147225|FG004|Participant Flow|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
10832912|NCT00147225|FG005|Participant Flow|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
10832913|NCT00147225|OG000|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832914|NCT00147225|OG001|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832915|NCT00147225|OG002|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832916|NCT00147225|OG003|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
10832917|NCT00147225|OG004|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832918|NCT00147225|OG005|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832919|NCT00147225|EG000|Reported Event|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832920|NCT00147225|EG001|Reported Event|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832921|NCT00147225|EG002|Reported Event|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
10832922|NCT00147225|EG003|Reported Event|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
10832923|NCT00147225|EG004|Reported Event|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832924|NCT00147225|EG005|Reported Event|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
10832925|NCT00147251|BG000|Baseline|Standard Treatment|standard targets of LDL-C < 100 mg/dL and BP < 130/85 mm Hg
10832926|NCT00147251|BG001|Baseline|Aggressive Treatment|/aggressive targets of LDL-C < 70 mg/dL plus BP < 115/75 mm Hg
10832927|NCT00147251|BG002|Baseline|Total|Total of all reporting groups
10832928|NCT00147251|FG000|Participant Flow|Standard Treatment|standard targets of LDL-C < 100 mg/dL and BP < 130/85 mm Hg
10832929|NCT00147251|FG001|Participant Flow|Aggressive Treatment|/aggressive targets of LDL-C < 70 mg/dL plus BP < 115/75 mm Hg
10832930|NCT00147251|OG000|Outcome|Standard Treatment|standard targets of LDL-C < 100 mg/dL and
10832931|NCT00147251|OG001|Outcome|Aggressive Treatment|/aggressive targets of LDL-C < 70 mg/dL
10832932|NCT00147251|OG000|Outcome|SANDS Control Group|Standard Treatment for blood pressure
10832933|NCT00147251|OG001|Outcome|SANDS Intervention Group|FDA approved drugs to treat blood pressure
10832934|NCT00147251|EG000|Reported Event|SANDS Control Group|Standard Treatment for blood pressure and cholesterol
10832935|NCT00147251|EG001|Reported Event|SANDS Intervention Group|FDA approved drugs to treat blood pressure and cholesterol
10832936|NCT00147316|BG000|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10832937|NCT00147316|FG000|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10832938|NCT00147316|OG000|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10832939|NCT00147316|EG000|Reported Event|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
10832940|NCT00147446|BG000|Baseline|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for multiple sclerosis(SMT-MS)at baseline
10832941|NCT00147446|BG001|Baseline|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
10832942|NCT00147446|BG002|Baseline|Total|Total of all reporting groups
10832943|NCT00147446|FG000|Participant Flow|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
10832944|NCT00147446|FG001|Participant Flow|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
10832945|NCT00147446|OG000|Outcome|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
10832946|NCT00147446|OG001|Outcome|Wait List Control Condition|Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
10832947|NCT00147446|OG000|Outcome|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
10832948|NCT00147446|OG001|Outcome|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
10832949|NCT00147446|EG000|Reported Event|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
10832950|NCT00147446|EG001|Reported Event|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
10832951|NCT00147498|BG000|Baseline|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
10832952|NCT00147498|BG001|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
10832953|NCT00147498|BG002|Baseline|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
10832954|NCT00147498|BG003|Baseline|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
10832955|NCT00147498|BG004|Baseline|Total|Total of all reporting groups
10832956|NCT00147498|FG000|Participant Flow|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
10832957|NCT00147498|FG001|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
10832958|NCT00147498|FG002|Participant Flow|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
10832959|NCT00147498|FG003|Participant Flow|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
10832960|NCT00147498|OG000|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
10832961|NCT00147498|OG001|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
10832962|NCT00147498|OG002|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
10832963|NCT00147498|OG003|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
10832964|NCT00147498|EG000|Reported Event|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
10832965|NCT00147498|EG001|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
10832966|NCT00147498|EG002|Reported Event|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
10832967|NCT00147498|EG003|Reported Event|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
10832968|NCT00147537|BG000|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832969|NCT00147537|BG001|Baseline|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832970|NCT00147537|BG002|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832971|NCT00147537|BG003|Baseline|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832972|NCT00147537|BG004|Baseline|Total|Total of all reporting groups
10832973|NCT00147537|FG000|Participant Flow|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832974|NCT00147537|FG001|Participant Flow|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832975|NCT00147537|FG002|Participant Flow|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832976|NCT00147537|FG003|Participant Flow|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832977|NCT00147537|FG004|Participant Flow|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832978|NCT00147537|FG005|Participant Flow|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832979|NCT00147537|FG006|Participant Flow|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832980|NCT00147537|FG007|Participant Flow|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832981|NCT00147537|FG008|Participant Flow|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832982|NCT00147537|FG009|Participant Flow|CP-751,871(F)+Paclitaxel(P)+Carboplatin(C) (Phase 2)|Single intravenous (IV) dose of CP-751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832983|NCT00147537|FG010|Participant Flow|Paclitaxel(P)+Carboplatin(C) (Phase 2)|Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832984|NCT00147537|OG000|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832985|NCT00147537|OG000|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832986|NCT00147537|OG001|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832987|NCT00147537|OG000|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832988|NCT00147537|OG001|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832989|NCT00147537|OG000|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832990|NCT00147537|OG001|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832991|NCT00147537|OG002|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832992|NCT00147537|OG003|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832993|NCT00147537|OG004|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832994|NCT00147537|OG005|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832995|NCT00147537|OG006|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10842813|NCT00249769|OG002|Outcome|MV Then LJEV|Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
10832996|NCT00147537|OG007|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832997|NCT00147537|OG000|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832998|NCT00147537|OG001|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10832999|NCT00147537|OG002|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833000|NCT00147537|OG003|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833001|NCT00147537|OG004|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833002|NCT00147537|OG005|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833003|NCT00147537|OG006|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833004|NCT00147537|OG007|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833005|NCT00147537|OG001|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833006|NCT00147537|OG002|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833007|NCT00147537|OG004|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10842814|NCT00249769|EG000|Reported Event|LJEV Then MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
10842815|NCT00249769|EG001|Reported Event|LJEV and MV|Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
11096001|NCT01561079|OG001|Outcome|FM-FHR 28 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11328378|NCT03426995|OG002|Outcome|Part A: GSK3358699 10 mg SD|Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
11096002|NCT01561079|OG002|Outcome|FM-FHR 32 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11096003|NCT01561079|OG003|Outcome|FM-FHR 36 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
11096004|NCT01561079|OG004|Outcome|FM-FHR 24 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
11096005|NCT01561079|OG005|Outcome|FM-FHR 28 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
11096006|NCT01561079|OG006|Outcome|FM-FHR 32 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
11096007|NCT01561079|OG007|Outcome|FM-FHR 36 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
11096008|NCT01561079|EG000|Reported Event|Maternal Buprenorphine Treatment|"Buprenorphine maintenance during pregnancy~Buprenorphine: Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.~Two severe adverse events were reported in the same infant patient. One infant had congenital heart disease and polydactyly"
11096009|NCT01561300|BG000|Baseline|Study Population|All participants who were randomised
11096010|NCT01561300|FG000|Participant Flow|Control, Then Washout, Then Tea|Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
11096011|NCT01561300|FG001|Participant Flow|Tea, Then Wash Out, Then Control|Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
11096012|NCT01561300|OG000|Outcome|Tea Beverage|Participants when they received tea
11096013|NCT01561300|OG001|Outcome|Control Beverage|Participants when they received control
11096014|NCT01561300|EG000|Reported Event|Tea Extract|Subjects when they consumed tea extract for one week
11096015|NCT01561300|EG001|Reported Event|Control|Subjects when they consumed control for one week
11096016|NCT01561300|EG002|Reported Event|Placebo|Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout
11096017|NCT01561313|BG000|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
11096018|NCT01561313|BG001|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
11096019|NCT01561313|BG002|Baseline|Total|Total of all reporting groups
11096020|NCT01561313|FG000|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
11096021|NCT01561313|FG001|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
11096022|NCT01561313|OG000|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
11096023|NCT01561313|OG001|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
11096024|NCT01561313|EG000|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
11096025|NCT01561313|EG001|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
11096026|NCT01561469|BG000|Baseline|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096027|NCT01561469|BG001|Baseline|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096028|NCT01561469|BG002|Baseline|Total|Total of all reporting groups
11096029|NCT01561469|FG000|Participant Flow|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096030|NCT01561469|FG001|Participant Flow|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096031|NCT01561469|OG000|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096032|NCT01561469|OG001|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
10833008|NCT00147537|OG005|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833009|NCT00147537|OG000|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833010|NCT00147537|OG001|Outcome|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
10833011|NCT00147537|OG000|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833012|NCT00147537|OG001|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833013|NCT00147537|OG002|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833014|NCT00147537|OG003|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP-751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833015|NCT00147537|EG000|Reported Event|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833016|NCT00147537|EG001|Reported Event|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833017|NCT00147537|EG002|Reported Event|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833018|NCT00147537|EG003|Reported Event|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833019|NCT00147537|EG004|Reported Event|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833020|NCT00147537|EG005|Reported Event|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10842816|NCT00249769|EG002|Reported Event|MV Then LJEV|Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
10842817|NCT00249795|BG000|Baseline|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
10842818|NCT00249795|BG001|Baseline|Placebo|matching placebo up to final follow-up visit
10842819|NCT00249795|BG002|Baseline|Total|Total of all reporting groups
10842820|NCT00249795|FG000|Participant Flow|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
10833021|NCT00147537|EG006|Reported Event|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833022|NCT00147537|EG007|Reported Event|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833023|NCT00147537|EG008|Reported Event|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833024|NCT00147537|EG009|Reported Event|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833025|NCT00147537|EG010|Reported Event|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
10833026|NCT00147537|EG011|Reported Event|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
10833027|NCT00147745|BG000|Baseline|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
10833028|NCT00147745|BG001|Baseline|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
10833029|NCT00147745|BG002|Baseline|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
10833030|NCT00147745|BG003|Baseline|Total|Total of all reporting groups
10833031|NCT00147745|FG000|Participant Flow|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
10833032|NCT00147745|FG001|Participant Flow|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
10833033|NCT00147745|FG002|Participant Flow|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
10833034|NCT00147745|OG000|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
10833035|NCT00147745|OG001|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
10833036|NCT00147745|OG002|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
10833037|NCT00147745|EG000|Reported Event|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
10833038|NCT00147745|EG001|Reported Event|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
10833039|NCT00147745|EG002|Reported Event|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
10833040|NCT00147823|BG000|Baseline|Vitoss Used With Bone Marrow Aspirate|Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate
10833041|NCT00147823|BG001|Baseline|Vitoss Only|Vitoss: Synthetic bone graft material alone
10833042|NCT00147823|BG002|Baseline|Total|Total of all reporting groups
10833043|NCT00147823|FG000|Participant Flow|Vitoss Alone|No bone marrow aspirate used
10833044|NCT00147823|FG001|Participant Flow|Vitoss With Bone Marrow Aspirate|"Addition of Vitoss to the bone marrow aspirate~Vitoss : Synthetic bone graft material"
10833045|NCT00147823|OG000|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
10833046|NCT00147823|OG001|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
10833047|NCT00147823|EG000|Reported Event|Vitoss Without Bone Marrow Aspirate|subjects who received Vitoss without bone marrow aspirate
10833048|NCT00147823|EG001|Reported Event|Vitoss With Bone Marrow Aspirate|subjects who received Vitoss with bone marrow aspirate
10833049|NCT00147966|BG000|Baseline|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
10833050|NCT00147966|FG000|Participant Flow|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
10833051|NCT00147966|OG000|Outcome|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
10833052|NCT00147966|EG000|Reported Event|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
10833053|NCT00148109|BG000|Baseline|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833054|NCT00148109|BG001|Baseline|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833055|NCT00148109|BG002|Baseline|Total|Total of all reporting groups
10833056|NCT00148109|FG000|Participant Flow|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833057|NCT00148109|FG001|Participant Flow|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833058|NCT00148109|OG000|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
10833059|NCT00148109|OG001|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
10833060|NCT00148109|EG000|Reported Event|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833061|NCT00148109|EG001|Reported Event|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
10833062|NCT00148122|BG000|Baseline|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
10833063|NCT00148122|FG000|Participant Flow|Docetaxel and Capecitabine|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
10833064|NCT00148122|OG000|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
10833065|NCT00148122|EG000|Reported Event|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
10833066|NCT00148317|BG000|Baseline|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
10833067|NCT00148317|FG000|Participant Flow|Overall Study|
10833068|NCT00148317|OG000|Outcome|Treatment Arm - Post Mobilization|This is the response rate assessed for patients after their bortezomib-based mobilization.
10833069|NCT00148317|OG001|Outcome|Treatment Arm - Responses Prior to Mobilization|This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
10833070|NCT00148317|OG000|Outcome|Treatment Arm - Post Bortezomib-based Mobilization|Yield of stem cell collection for the group that underwent bortezomib-based Mobilization
10833071|NCT00148317|OG000|Outcome|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
10833072|NCT00148317|EG000|Reported Event|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
10833073|NCT00148343|BG000|Baseline|Peroneal Nerve Stimulation|Odstock Dropped Foot Stimulator
10833074|NCT00148343|BG001|Baseline|Standard of Care|No device or ankle foot orthosis
10833075|NCT00148343|BG002|Baseline|Total|Total of all reporting groups
10833076|NCT00148343|FG000|Participant Flow|Peroneal Nerve Stimulation (PNS)|The peroneal nerve stimulator used in this study was the Odstock Dropped-Foot Stimulator (ODFS).
10833077|NCT00148343|FG001|Participant Flow|Standard of Care (no Device or Ankle Foot Orthosis)|Conventional Standard of Care was defined as either 1) no device or 2) a custom molded hinged ankle foot orthosis (AFO). Standard of care intervention device was determined based on clinical indication.
10833078|NCT00148343|OG000|Outcome|Peroneal Nerve Stimulation|Odstock Dropped Foot Stimulator
10833079|NCT00148343|OG001|Outcome|Standard of Care|No device or ankle foot orthosis
10833080|NCT00148343|EG000|Reported Event|Peroneal Nerve Stimulation|Odstock Dropped Foot Stimulator
10833081|NCT00148343|EG001|Reported Event|Standard of Care|No device or ankle foot orthosis
10833082|NCT00148668|BG000|Baseline|Arm 1|Herceptin/navelbine
10833083|NCT00148668|BG001|Baseline|Arm 2|Taxotere/carboplatin/herceptin
10833084|NCT00148668|BG002|Baseline|Total|Total of all reporting groups
10833085|NCT00148668|FG000|Participant Flow|Herceptin/Navelbine|Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
10833086|NCT00148668|FG001|Participant Flow|Taxotere/Carboplatin/Herceptin|Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
10833087|NCT00148668|OG000|Outcome|Arm 1|Herceptin/navelbine
10833088|NCT00148668|OG001|Outcome|Arm 2|Taxotere/carboplatin/herceptin
10833089|NCT00148668|EG000|Reported Event|Arm 1|Herceptin/navelbine
10833090|NCT00148668|EG001|Reported Event|Arm 2|Taxotere/carboplatin/herceptin
10833091|NCT00148759|BG000|Baseline|Group 1|Male subjects
10833092|NCT00148759|BG001|Baseline|Group 2|Female subjects
10833093|NCT00148759|BG002|Baseline|Total|Total of all reporting groups
10833094|NCT00148759|FG000|Participant Flow|Male Arm|Male subjects
10833095|NCT00148759|FG001|Participant Flow|Female Arm|Female subjects
10833096|NCT00148759|OG000|Outcome|Group 1|Male subjects
10833097|NCT00148759|OG001|Outcome|Group 2|Female subjects
10833098|NCT00148759|EG000|Reported Event|Group 1|Male subjects
10833099|NCT00148759|EG001|Reported Event|Group 2|Female subjects
10833100|NCT00148798|BG000|Baseline|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833101|NCT00148798|BG001|Baseline|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833102|NCT00148798|BG002|Baseline|Total|Total of all reporting groups
10833103|NCT00148798|FG000|Participant Flow|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833104|NCT00148798|FG001|Participant Flow|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833105|NCT00148798|OG000|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833106|NCT00148798|OG001|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833107|NCT00148798|OG000|Outcome|Cetuximab Concentration at End of Infusion Week 1|
10833108|NCT00148798|OG001|Outcome|Cetuximab Concentration Before Infusion Week 7|
10833109|NCT00148798|EG000|Reported Event|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833110|NCT00148798|EG001|Reported Event|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
10833111|NCT00148941|BG000|Baseline|SB213503 Lot 1 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833112|NCT00148941|BG001|Baseline|SB213503 Lot 2 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833113|NCT00148941|BG002|Baseline|SB213503 Lot 3 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833114|NCT00148941|BG003|Baseline|Infanrix + IPOL + M-M-R Group|Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833115|NCT00148941|BG004|Baseline|Total|Total of all reporting groups
10833116|NCT00148941|FG000|Participant Flow|SB213503 Lot 1 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833117|NCT00148941|FG001|Participant Flow|SB213503 Lot 2 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833118|NCT00148941|FG002|Participant Flow|SB213503 Lot 3 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833119|NCT00148941|FG003|Participant Flow|Infanrix + IPOL + M-M-R Group|Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833120|NCT00148941|OG000|Outcome|SB213503 Lot 1 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10842821|NCT00249795|FG001|Participant Flow|Placebo|matching placebo up to final follow-up visit
10842822|NCT00249795|OG000|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
10842823|NCT00249795|OG001|Outcome|Placebo|matching placebo up to final follow-up visit
10842824|NCT00249795|EG000|Reported Event|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
10833121|NCT00148941|OG001|Outcome|SB213503 Lot 2 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833122|NCT00148941|OG002|Outcome|SB213503 Lot 3 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833123|NCT00148941|OG003|Outcome|Infanrix + IPOL + M-M-R Group|Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833124|NCT00148941|EG000|Reported Event|SB213503 Lot 1 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833125|NCT00148941|EG001|Reported Event|SB213503 Lot 2 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833126|NCT00148941|EG002|Reported Event|SB213503 Lot 3 + M-M-R Group|Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833127|NCT00148941|EG003|Reported Event|Infanrix + IPOL + M-M-R Group|Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
10833128|NCT00148954|BG000|Baseline|VITALITY 2|VITALITY 2 ICD
10833129|NCT00148954|BG001|Baseline|Medtronic Family|Selected Medtronic family devices
10833130|NCT00148954|BG002|Baseline|Total|Total of all reporting groups
10833131|NCT00148954|FG000|Participant Flow|VITALITY 2|VITALITY 2 ICD
10833132|NCT00148954|FG001|Participant Flow|Medtronic Family|Selected Medtronic family devices
10833133|NCT00148954|OG000|Outcome|VITALITY 2|VITALITY 2 ICD
10833134|NCT00148954|OG001|Outcome|Medtronic Family|Selected Medtronic family devices
10833135|NCT00148954|EG000|Reported Event|VITALITY 2|This study did not collect serious adverse events
10833136|NCT00148954|EG001|Reported Event|Medtronic Family|This study did not collect serious adverse events
10833137|NCT00149214|BG000|Baseline|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833138|NCT00149214|BG001|Baseline|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833139|NCT00149214|BG002|Baseline|Total|Total of all reporting groups
10833140|NCT00149214|FG000|Participant Flow|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833141|NCT00149214|FG001|Participant Flow|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833142|NCT00149214|OG000|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833143|NCT00149214|OG001|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833144|NCT00149214|EG000|Reported Event|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833145|NCT00149214|EG001|Reported Event|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
10833146|NCT00149227|BG000|Baseline|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
10833147|NCT00149227|BG001|Baseline|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
10833148|NCT00149227|BG002|Baseline|Total|Total of all reporting groups
10842825|NCT00249795|EG001|Reported Event|Placebo|matching placebo up to final follow-up visit
10842826|NCT00249808|BG000|Baseline|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
11096033|NCT01561469|EG000|Reported Event|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096034|NCT01561469|EG001|Reported Event|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
11096035|NCT01561560|BG000|Baseline|OVERALL|Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
11096036|NCT01561560|FG000|Participant Flow|DAILIES TOTAL1, Then TRUEYE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
11096037|NCT01561560|FG001|Participant Flow|TRUEYE, Then DAILIES TOTAL1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
11096038|NCT01561560|OG000|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
11096039|NCT01561560|OG001|Outcome|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
11096040|NCT01561560|EG000|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
11096041|NCT01561560|EG001|Reported Event|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
11096042|NCT01561703|BG000|Baseline|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
11096043|NCT01561703|BG001|Baseline|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
11096044|NCT01561703|BG002|Baseline|Total|Total of all reporting groups
11096045|NCT01561703|FG000|Participant Flow|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
11096046|NCT01561703|FG001|Participant Flow|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
11096047|NCT01561703|OG000|Outcome|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
11096048|NCT01561703|OG001|Outcome|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
11096049|NCT01561703|EG000|Reported Event|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
11096050|NCT01561703|EG001|Reported Event|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
11096051|NCT01561716|BG000|Baseline|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
11096052|NCT01561716|BG001|Baseline|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
11096053|NCT01561716|BG002|Baseline|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
11096054|NCT01561716|BG003|Baseline|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
11096055|NCT01561716|BG004|Baseline|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
11096056|NCT01561716|BG005|Baseline|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
11096057|NCT01561716|BG006|Baseline|Total|Total of all reporting groups
11096058|NCT01561716|FG000|Participant Flow|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
11096059|NCT01561716|FG001|Participant Flow|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
10833149|NCT00149227|FG000|Participant Flow|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
10833150|NCT00149227|FG001|Participant Flow|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
10833151|NCT00149227|OG000|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
10833152|NCT00149227|OG001|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
10833153|NCT00149227|EG000|Reported Event|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
10833154|NCT00149227|EG001|Reported Event|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
10833155|NCT00149396|BG000|Baseline|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
10833156|NCT00149396|FG000|Participant Flow|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
10833157|NCT00149396|OG000|Outcome|All Patients|All patients in study
10833158|NCT00149396|OG000|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
10833159|NCT00149396|OG001|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
10833160|NCT00149396|OG002|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
10833161|NCT00149396|OG003|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
10833162|NCT00149396|OG000|Outcome|Stage 1|Escalating doses of NV1020: 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, 1x10^8 pfu
10833163|NCT00149396|OG001|Outcome|Stage 2|Optimal dose from Stage 1: 1x10^8 pfu
10833164|NCT00149396|OG001|Outcome|Dose Cohort 2|NV1020 Dose: 1x10^7 pfu (Stage 1)
10833165|NCT00149396|EG000|Reported Event|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
10833166|NCT00149630|BG000|Baseline|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
10833167|NCT00149630|BG001|Baseline|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
10833168|NCT00149630|BG002|Baseline|Total|Total of all reporting groups
11096060|NCT01561716|FG002|Participant Flow|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
11096061|NCT01561716|FG003|Participant Flow|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
11096062|NCT01561716|FG004|Participant Flow|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
10833169|NCT00149630|FG000|Participant Flow|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
10833170|NCT00149630|FG001|Participant Flow|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
10833171|NCT00149630|OG000|Outcome|Placebo CC|Subjects who received placebo with a genotype of CC.
10833172|NCT00149630|OG001|Outcome|Placebo CT/TT|Subjects who received placebo with genotype CT/TT.
10833173|NCT00149630|OG002|Outcome|Disulfiram CC|Subjects who received Disulfiram with genotype CC.
10833174|NCT00149630|OG003|Outcome|Disulfiram CT/TT|Subjects who received Disulfiram with genotype CT/TT.
10833175|NCT00149630|OG000|Outcome|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
10833176|NCT00149630|OG001|Outcome|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
10833177|NCT00149630|EG000|Reported Event|Disulfarim|250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.
10833178|NCT00149630|EG001|Reported Event|Placebo|Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
10833179|NCT00149643|BG000|Baseline|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
10833180|NCT00149643|BG001|Baseline|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
10833181|NCT00149643|BG002|Baseline|Total|Total of all reporting groups
10833182|NCT00149643|FG000|Participant Flow|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
10833183|NCT00149643|FG001|Participant Flow|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
11096063|NCT01561716|FG005|Participant Flow|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
11096064|NCT01561716|OG000|Outcome|At Rest|Energy expenditure at rest
11096065|NCT01561716|OG001|Outcome|Wii Fit Free Run|Energy expenditure during 30 min Wii Fit Free Run
11096066|NCT01561716|OG002|Outcome|Wii Fit Super Hula Hoop|Energy expenditure during 10 min Wii Fit Super Hula Hoop
10833184|NCT00149643|OG000|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
10833185|NCT00149643|OG001|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
10833186|NCT00149643|EG000|Reported Event|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
10833187|NCT00149643|EG001|Reported Event|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
10833188|NCT00149669|BG000|Baseline|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833189|NCT00149669|BG001|Baseline|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833190|NCT00149669|BG002|Baseline|Total|Total of all reporting groups
10833191|NCT00149669|FG000|Participant Flow|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833192|NCT00149669|FG001|Participant Flow|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833193|NCT00149669|OG000|Outcome|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833194|NCT00149669|OG001|Outcome|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833195|NCT00149669|OG000|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
10833196|NCT00149669|OG001|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
10833197|NCT00149669|EG000|Reported Event|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833198|NCT00149669|EG001|Reported Event|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
10833199|NCT00149734|BG000|Baseline|All Participants|Ondansetron followed by placebo group and Placebo followed by Ondansetron group
10833200|NCT00149734|FG000|Participant Flow|Ondansetron Followed by Placebo|Participants will take ondansetron (16mg) at one study visit, then a placebo at another study visit one week later.
10833201|NCT00149734|FG001|Participant Flow|Placebo Followed by Ondansetron|Participants will take a placebo at one study visit, then ondansetron (16mg) at another study visit one week later.
10833202|NCT00149734|OG000|Outcome|Ondansetron|Ondansetron (16 mg)
10833203|NCT00149734|OG001|Outcome|Placebo|Placebo
10833204|NCT00149734|EG000|Reported Event|Ondansetron|Ondansetron (16 mg)
10833205|NCT00149734|EG001|Reported Event|Placebo|Placebo
11096067|NCT01561716|OG003|Outcome|Wii Fit Advanced Steps|Energy expenditure during 10 min Wii Fit Advanced Steps
10833206|NCT00149747|BG000|Baseline|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
10833207|NCT00149747|BG001|Baseline|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
10833208|NCT00149747|BG002|Baseline|Total|Total of all reporting groups
10833209|NCT00149747|FG000|Participant Flow|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
10833210|NCT00149747|FG001|Participant Flow|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
10833211|NCT00149747|OG000|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
10833212|NCT00149747|OG001|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
10833213|NCT00149747|EG000|Reported Event|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
10833214|NCT00149747|EG001|Reported Event|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
10833215|NCT00149799|BG000|Baseline|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
10833216|NCT00149799|BG001|Baseline|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
10833217|NCT00149799|BG002|Baseline|Total|Total of all reporting groups
10833218|NCT00149799|FG000|Participant Flow|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
10833219|NCT00149799|FG001|Participant Flow|Phase II: Double-blind Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
10833220|NCT00149799|FG002|Participant Flow|Phase II: Double-blind Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
10833221|NCT00149799|OG000|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
10833222|NCT00149799|OG001|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
10833223|NCT00149799|OG000|Outcome|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
10833224|NCT00149799|EG000|Reported Event|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
10833225|NCT00149799|EG001|Reported Event|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
10833226|NCT00149799|EG002|Reported Event|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
10833227|NCT00149825|BG000|Baseline|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
10833228|NCT00149825|BG001|Baseline|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
10833229|NCT00149825|BG002|Baseline|Total|Total of all reporting groups
10833230|NCT00149825|FG000|Participant Flow|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
11096068|NCT01561716|OG004|Outcome|Wii Fit Rhythm Boxing|Energy expenditure during 10 min Wii Fit Rhythm Boxing
10833231|NCT00149825|FG001|Participant Flow|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
10833232|NCT00149825|OG000|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
10833233|NCT00149825|OG001|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
10833234|NCT00149825|EG000|Reported Event|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
10833235|NCT00149825|EG001|Reported Event|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
10833236|NCT00149838|BG000|Baseline|Active TMS|"Phase I participants receiving rTMS~Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks."
10833237|NCT00149838|BG001|Baseline|Sham TMS|"Phase I participants receiving sham stimulation~Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks."
10833238|NCT00149838|BG002|Baseline|Total|Total of all reporting groups
10833239|NCT00149838|FG000|Participant Flow|Active TMS|"Phase I participants receiving rTMS~Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks."
11096069|NCT01561716|OG005|Outcome|Treadmill Running/Walking|Energy expenditure during 30 min treadmill running/walking
10833240|NCT00149838|FG001|Participant Flow|Sham TMS|"Phase I participants receiving sham stimulation~Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks."
10833241|NCT00149838|FG002|Participant Flow|rTMS Extension|Phase II participants, all of whom did not meet remission requirements after phase 1. They will all receive active open label rTMS
10833242|NCT00149838|FG003|Participant Flow|Open Label Antidepressant Regimen|All patients who met remission who were then transitioned to medications after the TMS trial was completed.
10833243|NCT00149838|OG000|Outcome|Active TMS|"Phase I participants receiving rTMS~Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks."
10833244|NCT00149838|OG001|Outcome|Sham TMS|"Phase I participants receiving sham stimulation~Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks."
10833245|NCT00149838|OG002|Outcome|Active Open for 3 Weeks|"Phase II participants~Lower Dose rTMS: Participants who are unresponsive to Phase I treatment with rTMS will continue a lower dose of rTMS for an additional 3 to 7 weeks in Phase II."
10833246|NCT00149838|OG003|Outcome|Medication Followup|"Phase III participants~Antidepressant Regimen: Particpants who acheive remission with rTMS may start antidepressant medication in phase III."
10833247|NCT00149838|EG000|Reported Event|Active TMS|"Phase I participants receiving rTMS~Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks."
10833248|NCT00149838|EG001|Reported Event|Sham TMS|"Phase I participants receiving sham stimulation~Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks."
10833249|NCT00149838|EG002|Reported Event|rTMS Extension|rTMS. Phase II participants, all of whom did not meet remission requirements after phase I. They all receive active open label rTMS
10833250|NCT00149838|EG003|Reported Event|Open Label Antidepressant Regimen|All patients who met remission who were then transitioned to medications after the TMS trial was completed
10833251|NCT00149890|BG000|Baseline|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
10833252|NCT00149890|BG001|Baseline|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
10833253|NCT00149890|BG002|Baseline|Total|Total of all reporting groups
10833254|NCT00149890|FG000|Participant Flow|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
10833255|NCT00149890|FG001|Participant Flow|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
10833256|NCT00149890|OG000|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
10833257|NCT00149890|OG001|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
10833258|NCT00149890|EG000|Reported Event|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
10833259|NCT00149890|EG001|Reported Event|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
10842827|NCT00249808|FG000|Participant Flow|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
10842828|NCT00249808|OG000|Outcome|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
10833260|NCT00149994|BG000|Baseline|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
10833261|NCT00149994|BG001|Baseline|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
10833262|NCT00149994|BG002|Baseline|Total|Total of all reporting groups
10833263|NCT00149994|FG000|Participant Flow|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
10833264|NCT00149994|FG001|Participant Flow|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
10833265|NCT00149994|OG000|Outcome|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
10833266|NCT00149994|OG001|Outcome|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
10833267|NCT00149994|EG000|Reported Event|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
11096070|NCT01561716|EG000|Reported Event|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
11096071|NCT01561716|EG001|Reported Event|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
11096072|NCT01561716|EG002|Reported Event|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
11096073|NCT01561716|EG003|Reported Event|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
10833268|NCT00149994|EG001|Reported Event|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
10833269|NCT00150345|BG000|Baseline|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833270|NCT00150345|BG001|Baseline|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833271|NCT00150345|BG002|Baseline|Total|Total of all reporting groups
10833272|NCT00150345|FG000|Participant Flow|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833273|NCT00150345|FG001|Participant Flow|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833274|NCT00150345|OG000|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833275|NCT00150345|OG001|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833276|NCT00150345|OG001|Outcome|Deferred Voricoazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833277|NCT00150345|EG000|Reported Event|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833278|NCT00150345|EG001|Reported Event|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
10833279|NCT00150462|BG000|Baseline|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833280|NCT00150462|BG001|Baseline|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833281|NCT00150462|BG002|Baseline|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833282|NCT00150462|BG003|Baseline|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
11096074|NCT01561716|EG004|Reported Event|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
10833283|NCT00150462|BG004|Baseline|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833284|NCT00150462|BG005|Baseline|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833285|NCT00150462|BG006|Baseline|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833286|NCT00150462|BG007|Baseline|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833287|NCT00150462|BG008|Baseline|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833288|NCT00150462|BG009|Baseline|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
10833289|NCT00150462|BG010|Baseline|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
10833290|NCT00150462|BG011|Baseline|Total|Total of all reporting groups
10833291|NCT00150462|FG000|Participant Flow|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833292|NCT00150462|FG001|Participant Flow|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833293|NCT00150462|FG002|Participant Flow|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833294|NCT00150462|FG003|Participant Flow|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833295|NCT00150462|FG004|Participant Flow|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833296|NCT00150462|FG005|Participant Flow|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833297|NCT00150462|FG006|Participant Flow|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833298|NCT00150462|FG007|Participant Flow|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
11096075|NCT01561716|EG005|Reported Event|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
11096076|NCT01561755|BG000|Baseline|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
10833299|NCT00150462|FG008|Participant Flow|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833300|NCT00150462|FG009|Participant Flow|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
10833301|NCT00150462|FG010|Participant Flow|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
10833302|NCT00150462|OG000|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833303|NCT00150462|OG001|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833304|NCT00150462|OG002|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833305|NCT00150462|OG003|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833306|NCT00150462|OG004|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833307|NCT00150462|OG005|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833308|NCT00150462|OG006|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833309|NCT00150462|OG007|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833310|NCT00150462|OG008|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833311|NCT00150462|OG009|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
11096077|NCT01561755|BG001|Baseline|Placebo|Saline 2gr/kg over 2 days of saline
11096078|NCT01561755|BG002|Baseline|Total|Total of all reporting groups
11096079|NCT01561755|FG000|Participant Flow|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
11096080|NCT01561755|FG001|Participant Flow|Placebo|Saline 2gr/kg over 2 days of saline
10833312|NCT00150462|OG010|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
10833313|NCT00150462|OG009|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
10833314|NCT00150462|OG009|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
10833315|NCT00150462|OG010|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
10833316|NCT00150462|EG000|Reported Event|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833317|NCT00150462|EG001|Reported Event|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833318|NCT00150462|EG002|Reported Event|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833319|NCT00150462|EG003|Reported Event|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833320|NCT00150462|EG004|Reported Event|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833321|NCT00150462|EG005|Reported Event|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833322|NCT00150462|EG006|Reported Event|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833323|NCT00150462|EG007|Reported Event|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833324|NCT00150462|EG008|Reported Event|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
10833325|NCT00150462|EG009|Reported Event|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
10833326|NCT00150462|EG010|Reported Event|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
10833327|NCT00150592|BG000|Baseline|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
10833328|NCT00150592|BG001|Baseline|Placebo|
10833329|NCT00150592|BG002|Baseline|Total|Total of all reporting groups
10833330|NCT00150592|FG000|Participant Flow|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
10833331|NCT00150592|FG001|Participant Flow|Placebo|
10833332|NCT00150592|OG000|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
10833333|NCT00150592|OG001|Outcome|Placebo|
10833334|NCT00150592|EG000|Reported Event|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
10833335|NCT00150592|EG001|Reported Event|Placebo|
10833336|NCT00150618|BG000|Baseline|SPD503 (1 mg)|Guanfacine HCl once daily
10833337|NCT00150618|BG001|Baseline|SPD503 (2 mg)|Guanfacine HCl once daily
10833338|NCT00150618|BG002|Baseline|SPD503 (3 mg)|Guanfacine HCl once daily
10833339|NCT00150618|BG003|Baseline|SPD503 (4 mg)|Guanfacine HCl once daily
10833340|NCT00150618|BG004|Baseline|Placebo|once daily
10833341|NCT00150618|BG005|Baseline|Total|Total of all reporting groups
10833342|NCT00150618|FG000|Participant Flow|SPD503 (1 mg)|Guanfacine HCl once daily
10833343|NCT00150618|FG001|Participant Flow|SPD503 (2 mg)|Guanfacine HCl once daily
10833344|NCT00150618|FG002|Participant Flow|SPD503 (3 mg)|Guanfacine HCl once daily
10833345|NCT00150618|FG003|Participant Flow|SPD503 (4 mg)|Guanfacine HCl once daily
10833346|NCT00150618|FG004|Participant Flow|Placebo|once daily
10833347|NCT00150618|OG000|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
10833348|NCT00150618|OG001|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
10833349|NCT00150618|OG002|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
10833350|NCT00150618|OG003|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
10833351|NCT00150618|OG004|Outcome|Placebo|once daily
10833352|NCT00150618|EG000|Reported Event|SPD503 (1 mg)|Guanfacine HCl once daily
10833353|NCT00150618|EG001|Reported Event|SPD503 (2 mg)|Guanfacine HCl once daily
10833354|NCT00150618|EG002|Reported Event|SPD503 (3 mg)|Guanfacine HCl once daily
10833355|NCT00150618|EG003|Reported Event|SPD503 (4 mg)|Guanfacine HCl once daily
10833356|NCT00150618|EG004|Reported Event|Placebo|once daily
10833357|NCT00150800|BG000|Baseline|Brivaracetam|Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
10833358|NCT00150800|FG000|Participant Flow|Brivaracetam|Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
10833359|NCT00150800|OG000|Outcome|Brivaracetam (SS)|Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
10833360|NCT00150800|OG000|Outcome|Brivaracetam (POS-ES)|Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
10833361|NCT00150800|EG000|Reported Event|Brivaracetam|Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
10833362|NCT00150813|BG000|Baseline|Levetiracetam|Subjects received open-label Levetiracetam.
10833363|NCT00150813|FG000|Participant Flow|Levetiracetam|Subjects received open-label Levetiracetam.
10833364|NCT00150813|OG000|Outcome|Levetiracetam|Subjects received open-label Levetiracetam.
10833365|NCT00150813|EG000|Reported Event|Levetiracetam|Subjects received open-label Levetiracetam.
10833366|NCT00150969|BG000|Baseline|Phyloquinone|5 mg Vitamin K1
10833367|NCT00150969|BG001|Baseline|Placebo|dummy pill identicle to vitamin k
10833368|NCT00150969|BG002|Baseline|Total|Total of all reporting groups
10833369|NCT00150969|FG000|Participant Flow|Phyloquinone|5 mg Vitamin K1
10833370|NCT00150969|FG001|Participant Flow|Placebo|dummy pill identicle to vitamin k
10833371|NCT00150969|OG000|Outcome|Phyloquinone|5 mg Vitamin K1 daily
10833372|NCT00150969|OG001|Outcome|Placebo|dummy pill identicle to vitamin k
10833373|NCT00150969|OG000|Outcome|Phyloquinone|5 mg Vitamin K1
10833374|NCT00150969|EG000|Reported Event|Phyloquinone|5 mg Vitamin K1
10833375|NCT00150969|EG001|Reported Event|Placebo|dummy pill identicle to vitamin k
10833376|NCT00151281|BG000|Baseline|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
10833377|NCT00151281|FG000|Participant Flow|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
10833378|NCT00151281|OG000|Outcome|Study Treatment Arm|"Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide: Induction phase (month 1-3)~PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.~Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.~Maintenance phase (month 4-12)~Daily low dose thalidomide (50-100 mg/d)~PEPC QOD or fractionated weekly basis.~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~Daily low dose thalidomide (50-100mg/d)~PEPC QOD or fractionated weekly basis~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
10833379|NCT00151281|OG000|Outcome|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
10833380|NCT00151281|EG000|Reported Event|Study Treatment Arm|"Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide: Induction phase (month 1-3)~PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.~Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.~Maintenance phase (month 4-12)~Daily low dose thalidomide (50-100 mg/d)~PEPC QOD or fractionated weekly basis.~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~Daily low dose thalidomide (50-100mg/d)~PEPC QOD or fractionated weekly basis~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
10833381|NCT00151320|BG000|Baseline|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
10833382|NCT00151320|BG001|Baseline|Untreated MCL|with untreated mantle cell Non-Hodgkin's Lymphoma
10833383|NCT00151320|BG002|Baseline|Total|Total of all reporting groups
10833384|NCT00151320|FG000|Participant Flow|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
10833385|NCT00151320|OG000|Outcome|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
10833386|NCT00151320|OG001|Outcome|Untreated MCL|with untreated mantle cell Non-Hodgkin's Lymphoma
10833387|NCT00151320|EG000|Reported Event|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
10833388|NCT00151372|BG000|Baseline|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
10833389|NCT00151372|BG001|Baseline|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
10833390|NCT00151372|BG002|Baseline|Total|Total of all reporting groups
10833391|NCT00151372|FG000|Participant Flow|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
10833392|NCT00151372|FG001|Participant Flow|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
10833393|NCT00151372|OG000|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
10833394|NCT00151372|OG001|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
10833395|NCT00151372|EG000|Reported Event|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
10833396|NCT00151372|EG001|Reported Event|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
10833397|NCT00151411|BG000|Baseline|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
10833398|NCT00151411|BG001|Baseline|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
10833399|NCT00151411|BG002|Baseline|Total|Total of all reporting groups
10833400|NCT00151411|FG000|Participant Flow|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
10833401|NCT00151411|FG001|Participant Flow|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
10833402|NCT00151411|OG000|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
10833403|NCT00151411|OG001|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
10833404|NCT00151411|EG000|Reported Event|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
10833405|NCT00151411|EG001|Reported Event|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
10833406|NCT00151476|BG000|Baseline|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833407|NCT00151476|BG001|Baseline|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833408|NCT00151476|BG002|Baseline|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833409|NCT00151476|BG003|Baseline|Total|Total of all reporting groups
11096081|NCT01561755|OG000|Outcome|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
11096082|NCT01561755|OG001|Outcome|Placebo|Saline 2gr/kg over 2 days of saline
11096083|NCT01561755|EG000|Reported Event|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
11096084|NCT01561755|EG001|Reported Event|Placebo|Saline 2gr/kg over 2 days of saline
11096085|NCT01561833|BG000|Baseline|Sorafenib|"Sorafenib, 400 mg PO twice daily~Sorafenib: Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met."
11096086|NCT01561833|FG000|Participant Flow|Sorafenib|"Sorafenib, 400 mg PO twice daily~Sorafenib: Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met."
11096087|NCT01561833|OG000|Outcome|Sorafenib|sorafenib
11096088|NCT01561833|EG000|Reported Event|Sorafenib|sorafenib
11096089|NCT01561898|BG000|Baseline|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096090|NCT01561898|BG001|Baseline|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096091|NCT01561898|BG002|Baseline|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096092|NCT01561898|BG003|Baseline|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096093|NCT01561898|BG004|Baseline|Total|Total of all reporting groups
11096094|NCT01561898|FG000|Participant Flow|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096095|NCT01561898|FG001|Participant Flow|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096096|NCT01561898|FG002|Participant Flow|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096097|NCT01561898|FG003|Participant Flow|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096098|NCT01561898|OG000|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096099|NCT01561898|OG001|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096100|NCT01561898|OG002|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096101|NCT01561898|OG003|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096102|NCT01561898|OG000|Outcome|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096103|NCT01561898|EG000|Reported Event|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
11096104|NCT01561963|BG000|Baseline|Apremilast and Rifampin|"Participants received the following 3 treatment regimens:~Period 1: A single oral dose of 30 mg apremilast on Day 1; Period 2: A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5; Period 3: Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20."
11096105|NCT01561963|FG000|Participant Flow|Apremilast and Rifampin|"Participants received the following 3 treatment regimens:~Period 1: A single oral dose of 30 mg apremilast on Day 1; Period 2: A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous (IV) infusion of 600 mg rifampin on Day 5; Period 3: Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20."
11096106|NCT01561963|OG000|Outcome|Apremilast Alone|Participants received a single oral dose of 30 mg apremilast on Day 1 (Period 1).
11096107|NCT01561963|OG001|Outcome|Apremilast + IV Rifampin|Participants received a single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2).
11096108|NCT01561963|OG002|Outcome|Apremilast + Multiple Dose Oral Rifampin|Participants received once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).
11096109|NCT01561963|EG000|Reported Event|Apremilast Alone|Participants received a single oral dose of 30 mg apremilast on Day 1 (Period 1).
11096110|NCT01561963|EG001|Reported Event|Apremilast + IV Rifampin|Participants received a single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2).
11096111|NCT01561963|EG002|Reported Event|Apremilast + Multiple Dose Oral Rifampin|Participants received once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).
11096112|NCT01561963|EG003|Reported Event|Overall Study - All Treatment Regimens|"Participants received the following 3 treatment regimens:~Period 1: A single oral dose of 30 mg apremilast on Day 1; Period 2: A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5; Period 3: Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20."
11096113|NCT01561976|BG000|Baseline|METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096114|NCT01561976|BG001|Baseline|METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096115|NCT01561976|BG002|Baseline|METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096116|NCT01561976|BG003|Baseline|METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096117|NCT01561976|BG004|Baseline|METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096118|NCT01561976|BG005|Baseline|METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096119|NCT01561976|BG006|Baseline|Total|Total of all reporting groups
11328379|NCT03426995|OG003|Outcome|Part A: GSK3358699 20 mg SD|Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
11096120|NCT01561976|FG000|Participant Flow|METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 milligrams (mg)/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1 (day after the dosing day), breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post dose respectively.
11096121|NCT01561976|FG001|Participant Flow|METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096122|NCT01561976|FG002|Participant Flow|METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096123|NCT01561976|FG003|Participant Flow|METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096124|NCT01561976|FG004|Participant Flow|METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte|In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096125|NCT01561976|FG005|Participant Flow|METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed|In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096126|NCT01561976|OG000|Outcome|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096127|NCT01561976|OG001|Outcome|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
10833410|NCT00151476|FG000|Participant Flow|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833411|NCT00151476|FG001|Participant Flow|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833412|NCT00151476|OG000|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833413|NCT00151476|OG001|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833414|NCT00151476|OG002|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833415|NCT00151476|OG003|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833416|NCT00151476|EG000|Reported Event|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
10833417|NCT00151775|BG000|Baseline|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833418|NCT00151775|BG001|Baseline|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833419|NCT00151775|BG002|Baseline|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833420|NCT00151775|BG003|Baseline|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833421|NCT00151775|BG004|Baseline|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833422|NCT00151775|BG005|Baseline|Total|Total of all reporting groups
10833423|NCT00151775|FG000|Participant Flow|Cohort A: High Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
10833424|NCT00151775|FG001|Participant Flow|Cohort A: Low Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
11336175|NCT03562663|BG001|Baseline|Sham tDCS|"Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336176|NCT03562663|BG002|Baseline|Total|Total of all reporting groups
11336177|NCT03562663|FG000|Participant Flow|Active tDCS|"Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention.~Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336178|NCT03562663|FG001|Participant Flow|Sham tDCS|"Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336179|NCT03562663|OG000|Outcome|Active tDCS|"Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention.~Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336180|NCT03562663|OG001|Outcome|Sham tDCS|"Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336181|NCT03562663|EG000|Reported Event|Active tDCS|"Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention.~Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336182|NCT03562663|EG001|Reported Event|Sham tDCS|"Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training.~Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study."
11336183|NCT03562988|BG000|Baseline|All Study Participants|All Study Participants
11336184|NCT03562988|FG000|Participant Flow|Vitamin C Gummy, Then Vitamin C Caplet|The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period.
11336185|NCT03562988|FG001|Participant Flow|Vitamin C Tablet, Then Vitamin C Gummy|The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period.
11336186|NCT03562988|OG000|Outcome|Vitamin C Gummy|A single oral dose of vitamin C gummy
11336187|NCT03562988|OG001|Outcome|Vitamin C Caplet|A single oral dose of vitamin C caplet
11336188|NCT03562988|OG000|Outcome|Vitamin C Gummy|"A single oral dose of vitamin C gummy to monitor vitamin C blood levels~Vitamin C gummy: vitamin C"
11336189|NCT03562988|OG001|Outcome|Vitamin C Tablet|"A single oral dose of vitamin C tablet to monitor vitamin C blood levels~vitamin C tablet: vitamin C"
11336190|NCT03562988|OG000|Outcome|Vitamin C Gummy|"A single oral dose of gummy vitamin C to monitor vitamin C blood levels~Vitamin C gummy: vitamin C"
11336191|NCT03562988|OG001|Outcome|Vitamin C Tablet|"A single oral dose of tablet vitamin C to monitor vitamin C blood levels~Vitamin C tablet: vitamin C"
11336192|NCT03562988|EG000|Reported Event|Vitamin C Gummy|"A single oral dose of gummy vitamin C to monitor vitamin C blood levels~Vitamin C gummy: vitamin C"
11336193|NCT03562988|EG001|Reported Event|Vitamin C Tablet|"A single oral dose of tablet vitamin C to monitor vitamin C blood levels~Vitamin C tablet: vitamin C"
11336194|NCT03563027|BG000|Baseline|Control|This arm serves as control and uses a wearable device to track daily step counts
11336195|NCT03563027|BG001|Baseline|Social Incentive Gamification|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game"
11336196|NCT03563027|BG002|Baseline|Social Incentive Gamification and Financial Incentive|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game~Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met"
11336197|NCT03563027|BG003|Baseline|Total|Total of all reporting groups
10833425|NCT00151775|FG002|Participant Flow|Cohort A: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
10833426|NCT00151775|FG003|Participant Flow|Cohort A: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
10833427|NCT00151775|FG004|Participant Flow|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833428|NCT00151775|FG005|Participant Flow|Cohort B: High Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
10833429|NCT00151775|FG006|Participant Flow|Cohort B: Low Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
10833430|NCT00151775|FG007|Participant Flow|Cohort B: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
10833431|NCT00151775|FG008|Participant Flow|Cohort B: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
10833432|NCT00151775|FG009|Participant Flow|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833433|NCT00151775|FG010|Participant Flow|Cohort C: OM in Periods 2, 3, 4|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833434|NCT00151775|FG011|Participant Flow|Cohort C: Placebo in Period 3 (From OM in Period 2)|Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
10833435|NCT00151775|OG000|Outcome|Cohort A|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
10833436|NCT00151775|OG001|Outcome|Cohort B|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
10833437|NCT00151775|OG002|Outcome|Cohorts A + B|Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
10833438|NCT00151775|OG000|Outcome|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833439|NCT00151775|OG001|Outcome|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833440|NCT00151775|OG002|Outcome|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
11336198|NCT03563027|FG000|Participant Flow|Control|This arm serves as control and uses a wearable device to track daily step counts
10833441|NCT00151775|OG003|Outcome|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
10833442|NCT00151775|OG004|Outcome|Cohorts A + B: Low Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
10833443|NCT00151775|OG005|Outcome|Cohorts A + B: High Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
10833444|NCT00151775|OG000|Outcome|Cohort A: OM Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
10833445|NCT00151775|OG001|Outcome|Cohort A: Placebo Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
10833446|NCT00151775|OG002|Outcome|Cohort B: OM Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
10833447|NCT00151775|OG003|Outcome|Cohort B: Placebo Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
10833448|NCT00151775|OG004|Outcome|Cohorts A + B: OM Period 3|Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
10833449|NCT00151775|OG005|Outcome|Cohorts A + B: Placebo Period 3|Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
10833450|NCT00151775|OG000|Outcome|Cohort C: OM Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
10833451|NCT00151775|OG001|Outcome|Cohort C: Placebo Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
10833452|NCT00151775|OG000|Outcome|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833453|NCT00151775|OG001|Outcome|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833454|NCT00151775|OG002|Outcome|Cohorts A + B: Period 4 Open-label OM|All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833455|NCT00151775|OG000|Outcome|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833456|NCT00151775|EG000|Reported Event|Cohort A: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
10833457|NCT00151775|EG001|Reported Event|Cohort A: Period 2 Low Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
10833458|NCT00151775|EG002|Reported Event|Cohort A: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
10833459|NCT00151775|EG003|Reported Event|Cohort A: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
10833460|NCT00151775|EG004|Reported Event|Cohort A: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
10833461|NCT00151775|EG005|Reported Event|Cohort A: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
10833462|NCT00151775|EG006|Reported Event|Cohort A: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833463|NCT00151775|EG007|Reported Event|Cohort B: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
10833464|NCT00151775|EG008|Reported Event|Cohort B: Period 2 Low Dose OM|For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
10833465|NCT00151775|EG009|Reported Event|Cohort B: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
10833466|NCT00151775|EG010|Reported Event|Cohort B: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
10833467|NCT00151775|EG011|Reported Event|Cohort B: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
10833468|NCT00151775|EG012|Reported Event|Cohort B: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
10833469|NCT00151775|EG013|Reported Event|Cohort B: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833470|NCT00151775|EG014|Reported Event|Cohort C: Period 2 Open-label OM|The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
10833471|NCT00151775|EG015|Reported Event|Cohort C: Period 3 OM Dose Continued|The 0.3 mg/kg dose of OM was continued for these participants
10833472|NCT00151775|EG016|Reported Event|Cohort C: Period 3 Placebo|The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
10833473|NCT00151775|EG017|Reported Event|Cohort C: Period 4 Open-label OM|Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
10833474|NCT00151814|BG000|Baseline|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833475|NCT00151814|BG001|Baseline|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833476|NCT00151814|BG002|Baseline|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833477|NCT00151814|BG003|Baseline|Total|Total of all reporting groups
10833478|NCT00151814|FG000|Participant Flow|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
11336199|NCT03563027|FG001|Participant Flow|Social Incentive Gamification|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game"
10833479|NCT00151814|FG001|Participant Flow|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833480|NCT00151814|FG002|Participant Flow|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833481|NCT00151814|OG000|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833482|NCT00151814|OG001|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833483|NCT00151814|EG000|Reported Event|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833484|NCT00151814|EG001|Reported Event|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833485|NCT00151814|EG002|Reported Event|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
10833486|NCT00151892|BG000|Baseline|SPD476|2.4 g/day QD
10833487|NCT00151892|BG001|Baseline|Asacol|1.6g/day administered 800 mg BID
10833488|NCT00151892|BG002|Baseline|Total|Total of all reporting groups
10833489|NCT00151892|FG000|Participant Flow|SPD476|2.4 g/day once daily (QD)
10833490|NCT00151892|FG001|Participant Flow|Asacol|1.6g/day administered 800 mg twice daily (BID)
10833491|NCT00151892|OG000|Outcome|SPD476|2.4 g/day QD
10833492|NCT00151892|OG001|Outcome|Asacol|1.6g/day administered 800 mg BID
10833493|NCT00151892|EG000|Reported Event|SPD476|2.4 g/day QD
10833494|NCT00151892|EG001|Reported Event|Asacol|1.6g/day administered 800 mg BID
10833495|NCT00151996|BG000|Baseline|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
10833496|NCT00151996|BG001|Baseline|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
10833497|NCT00151996|BG002|Baseline|Total|Total of all reporting groups
10833498|NCT00151996|FG000|Participant Flow|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
10833499|NCT00151996|FG001|Participant Flow|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
10833500|NCT00151996|OG000|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
10833501|NCT00151996|OG001|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
10833502|NCT00151996|EG000|Reported Event|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
10833503|NCT00151996|EG001|Reported Event|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
10833504|NCT00152009|BG000|Baseline|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833505|NCT00152009|BG001|Baseline|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833506|NCT00152009|BG002|Baseline|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833507|NCT00152009|BG003|Baseline|Placebo|Subjects were randomized to receive Placebo once-daily.
10833508|NCT00152009|BG004|Baseline|Total|Total of all reporting groups
10833509|NCT00152009|FG000|Participant Flow|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833510|NCT00152009|FG001|Participant Flow|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833511|NCT00152009|FG002|Participant Flow|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833512|NCT00152009|FG003|Participant Flow|Placebo|Subjects were randomized to receive Placebo once-daily.
10833513|NCT00152009|OG000|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833514|NCT00152009|OG001|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833515|NCT00152009|OG002|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833516|NCT00152009|OG003|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
10833517|NCT00152009|EG000|Reported Event|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833518|NCT00152009|EG001|Reported Event|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833519|NCT00152009|EG002|Reported Event|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
10833520|NCT00152009|EG003|Reported Event|Placebo|Subjects were randomized to receive Placebo once-daily.
10833521|NCT00152464|BG000|Baseline|Placebo (PBO)|Placebo was administered as oral drops twice daily.
10833522|NCT00152464|BG001|Baseline|Levocetirizine (LCTZ)|0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
10833523|NCT00152464|BG002|Baseline|Total Title|
10833524|NCT00152464|FG000|Participant Flow|Placebo (PBO)|Placebo was administered as oral drops twice daily.
10833525|NCT00152464|FG001|Participant Flow|Levocetirizine (LCTZ)|0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
10833526|NCT00152464|OG000|Outcome|Placebo (PBO)|Placebo was administered as oral drops twice daily.
10833527|NCT00152464|OG001|Outcome|Levocetirizine (LCTZ)|0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
10833528|NCT00152464|EG000|Reported Event|Placebo (PBO)|Placebo was administered as oral drops twice daily.
10833529|NCT00152464|EG001|Reported Event|Levocetirizine (LCTZ)|0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
10833530|NCT00152516|BG000|Baseline|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
10833531|NCT00152516|FG000|Participant Flow|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
10833532|NCT00152516|OG000|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
10833533|NCT00152516|EG000|Reported Event|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
10833534|NCT00152763|BG000|Baseline|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833535|NCT00152763|BG001|Baseline|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
10833536|NCT00152763|BG002|Baseline|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833537|NCT00152763|BG003|Baseline|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
10833538|NCT00152763|BG004|Baseline|Total|Total of all reporting groups
10833539|NCT00152763|FG000|Participant Flow|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833540|NCT00152763|FG001|Participant Flow|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
10833541|NCT00152763|FG002|Participant Flow|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833542|NCT00152763|FG003|Participant Flow|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
10833543|NCT00152763|OG000|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833544|NCT00152763|OG001|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
10833545|NCT00152763|OG002|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833546|NCT00152763|OG003|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
10833547|NCT00152763|OG000|Outcome|Usual Cardiac Care|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
10833548|NCT00152763|OG001|Outcome|Cognitive Behaviour Therapy|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
10833549|NCT00152763|EG000|Reported Event|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833550|NCT00152763|EG001|Reported Event|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
10833551|NCT00152763|EG002|Reported Event|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
10833552|NCT00152763|EG003|Reported Event|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
10833553|NCT00152971|BG000|Baseline|Dabigatran 220mg|qd (once daily) oral
10833554|NCT00152971|BG001|Baseline|Dabigatran 150mg|qd (once daily) oral
10833555|NCT00152971|BG002|Baseline|Enoxaparin|30mg bid (twice daily) subcutaneous
10833556|NCT00152971|BG003|Baseline|Total|Total of all reporting groups
10833557|NCT00152971|FG000|Participant Flow|Dabigatran 220mg|qd (once daily) oral
10833558|NCT00152971|FG001|Participant Flow|Dabigatran 150mg|qd (once daily) oral
10833559|NCT00152971|FG002|Participant Flow|Enoxaparin|30mg bid (twice daily) subcutaneous
10833560|NCT00152971|OG000|Outcome|Dabigatran 220mg|qd (once daily) oral
10833561|NCT00152971|OG001|Outcome|Dabigatran 150mg|qd (once daily) oral
10833562|NCT00152971|OG002|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
10833563|NCT00152971|EG000|Reported Event|Dabigatran 220mg|qd (once daily) oral
10833564|NCT00152971|EG001|Reported Event|Dabigatran 150mg|qd (once daily) oral
10833565|NCT00152971|EG002|Reported Event|Enoxaparin|30mg bid (twice daily) subcutaneous
10833566|NCT00153062|BG000|Baseline|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
10833567|NCT00153062|BG001|Baseline|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
10833568|NCT00153062|BG002|Baseline|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
10833569|NCT00153062|BG003|Baseline|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
10833570|NCT00153062|BG004|Baseline|Total|Total of all reporting groups
10833571|NCT00153062|FG000|Participant Flow|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
10833572|NCT00153062|FG001|Participant Flow|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
10833573|NCT00153062|FG002|Participant Flow|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
10833574|NCT00153062|FG003|Participant Flow|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
10833575|NCT00153062|OG000|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
10833576|NCT00153062|OG001|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
10833577|NCT00153062|OG000|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
10833578|NCT00153062|OG001|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
10833579|NCT00153062|EG000|Reported Event|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
10833580|NCT00153062|EG001|Reported Event|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
10833581|NCT00153062|EG002|Reported Event|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
10833582|NCT00153062|EG003|Reported Event|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
10833583|NCT00153101|BG000|Baseline|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
10833584|NCT00153101|BG001|Baseline|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
10833585|NCT00153101|BG002|Baseline|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
10833586|NCT00153101|BG003|Baseline|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
10833587|NCT00153101|BG004|Baseline|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
10833588|NCT00153101|BG005|Baseline|Total|Total of all reporting groups
10833589|NCT00153101|FG000|Participant Flow|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
10833590|NCT00153101|FG001|Participant Flow|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
10833591|NCT00153101|FG002|Participant Flow|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
10833592|NCT00153101|FG003|Participant Flow|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
10833593|NCT00153101|FG004|Participant Flow|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
10833594|NCT00153101|OG000|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
10833595|NCT00153101|OG001|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
10833596|NCT00153101|OG002|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
10833597|NCT00153101|OG000|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
10833598|NCT00153101|OG001|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
10833599|NCT00153101|OG000|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
10833600|NCT00153101|OG001|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
10833601|NCT00153101|EG000|Reported Event|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
10833602|NCT00153101|EG001|Reported Event|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
10833603|NCT00153101|EG002|Reported Event|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
10833604|NCT00153101|EG003|Reported Event|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
10833605|NCT00153101|EG004|Reported Event|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
10833606|NCT00153166|BG000|Baseline|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
10833607|NCT00153166|BG001|Baseline|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
10833608|NCT00153166|BG002|Baseline|PAD Without Diabetes|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
10833609|NCT00153166|BG003|Baseline|Total|Total of all reporting groups
10833610|NCT00153166|FG000|Participant Flow|Healthy Controls|Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
10833611|NCT00153166|FG001|Participant Flow|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
10833612|NCT00153166|FG002|Participant Flow|PAD (Excluding Patients With Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
10833613|NCT00153166|OG000|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
10833614|NCT00153166|OG001|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
10833615|NCT00153166|OG002|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
10833616|NCT00153166|EG000|Reported Event|Received Atorvastatin/Pioglitazone|Including healthy subjects and subjects with PAD
10833617|NCT00153166|EG001|Reported Event|Received Atorvastatin/Placebo|Including healthy subjects and subjects with PAD
10833618|NCT00153166|EG002|Reported Event|Received Placebo/Pioglitazone|Including healthy subjects and subjects with PAD
10833619|NCT00153166|EG003|Reported Event|Received Placebo/Placebo|Including healthy subjects and subjects with PAD
10833620|NCT00153179|BG000|Baseline|Healthy Controls|
10833621|NCT00153179|BG001|Baseline|Metabolic Syndrome|
10833622|NCT00153179|BG002|Baseline|Total|Total of all reporting groups
10833623|NCT00153179|FG000|Participant Flow|Healthy Controls, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
10833624|NCT00153179|FG001|Participant Flow|Healthy Controls, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
10833625|NCT00153179|FG002|Participant Flow|Metabolic Syndrome, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
10833626|NCT00153179|FG003|Participant Flow|Metabolic Syndrome, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
10833627|NCT00153179|OG000|Outcome|Healthy Controls, Placebo Treatment|
10833628|NCT00153179|OG001|Outcome|Healthy Controls, Acipimox Treatment|
10833629|NCT00153179|OG002|Outcome|Metabolic Syndrome, Placebo Treatment|
10833630|NCT00153179|OG003|Outcome|Metabolic Syndrome, Acipimox Treatment|
10833631|NCT00153179|EG000|Reported Event|Healthy Controls|Healthy subjects will be ≥18 years of age and have no known medical problems, have a normal cardiovascular exam and a fasting glucose <110 mg/dL determined during a screening visit.
10833632|NCT00153179|EG001|Reported Event|Metabolic Syndrome|The patient population for this specific aim will include non-diabetic subjects with the metabolic syndrome who are ≥18 years of age. The metabolic syndrome will be defined as the presence of 4 or 5 components of the syndrome as defined by the National Cholesterol Education Program including abdominal obesity, elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL) (54), low HDL, elevated fasting blood triglycerides (Trigs > 150 mg/dL), and hypertension (BP > 140/90 mm HG) (55). Patients will be excluded from this protocol if they have any of the following: diabetes mellitus, untreated hypercholesterolemia (LDL > 75th percentile for age), cigarette smoking within 1 year, renal insufficiency (creatinine > 1.4 mg/dl), blood dyscrasia, or hepatic dysfunction (ALT > 2x normal). Potential subjects will also be excluded if they are infected with the human immunodeficiency virus or have psychiatric illness requiring more than one medication for depression or anxiety.
10833633|NCT00153803|BG000|Baseline|Tarceva|"Tarceva 150mg~Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy."
10833634|NCT00153803|BG001|Baseline|Placebo|"Matched Placebo~Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy."
10833635|NCT00153803|BG002|Baseline|Total|Total of all reporting groups
10833636|NCT00153803|FG000|Participant Flow|Tarceva|"Tarceva 150mg~Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy."
10833637|NCT00153803|FG001|Participant Flow|Placebo|"Matched Placebo~Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy."
10833638|NCT00153803|OG000|Outcome|Tarceva|"Tarceva 150mg~Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy."
10833639|NCT00153803|OG001|Outcome|Placebo|"Matched Placebo~Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy."
10833640|NCT00153803|OG000|Outcome|Tarceva|"Tarceva 150mg~Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 2 years of therapy."
10833641|NCT00153803|EG000|Reported Event|Chemoradiation Before Tarceva|
10833642|NCT00153803|EG001|Reported Event|Chemoradiation Before Placebo|
10833643|NCT00153803|EG002|Reported Event|Tarceva|"Tarceva 150mg~Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy."
10833644|NCT00153803|EG003|Reported Event|Placebo|"Matched Placebo~Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy."
10833645|NCT00153816|BG000|Baseline|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
10833646|NCT00153816|BG001|Baseline|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833647|NCT00153816|BG002|Baseline|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833648|NCT00153816|BG003|Baseline|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833649|NCT00153816|BG004|Baseline|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833650|NCT00153816|BG005|Baseline|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833651|NCT00153816|BG006|Baseline|Total|Total of all reporting groups
10833652|NCT00153816|FG000|Participant Flow|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
10833653|NCT00153816|FG001|Participant Flow|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833654|NCT00153816|FG002|Participant Flow|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833655|NCT00153816|FG003|Participant Flow|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833656|NCT00153816|FG004|Participant Flow|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833657|NCT00153816|FG005|Participant Flow|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833658|NCT00153816|OG000|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
10833659|NCT00153816|OG001|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833660|NCT00153816|OG002|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833661|NCT00153816|OG003|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833662|NCT00153816|OG004|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833663|NCT00153816|OG005|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833664|NCT00153816|EG000|Reported Event|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
10833665|NCT00153816|EG001|Reported Event|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833666|NCT00153816|EG002|Reported Event|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833667|NCT00153816|EG003|Reported Event|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
10833668|NCT00153816|EG004|Reported Event|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
10833669|NCT00153816|EG005|Reported Event|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
11096128|NCT01561976|OG002|Outcome|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096129|NCT01561976|EG000|Reported Event|METLEAD ForteSR-Fasting|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096130|NCT01561976|EG001|Reported Event|METLEAD ForteSR-Fed|Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096131|NCT01561976|EG002|Reported Event|METLEAD G2 Forte|Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
11096132|NCT01562028|BG000|Baseline|T790M Positive|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096133|NCT01562028|BG001|Baseline|T790M Negative|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096134|NCT01562028|BG002|Baseline|Total|Total of all reporting groups
11096135|NCT01562028|FG000|Participant Flow|T790M Positive|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096136|NCT01562028|FG001|Participant Flow|T790M Negative|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096137|NCT01562028|OG000|Outcome|T790M Positive|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096138|NCT01562028|OG001|Outcome|T790M Negative|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096139|NCT01562028|EG000|Reported Event|T790M Positive|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096140|NCT01562028|EG001|Reported Event|T790M Negative|Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
11096141|NCT01562041|BG000|Baseline|Ranolazine 500 mg|Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days.
11096142|NCT01562041|FG000|Participant Flow|Ranolazine 500 mg|Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days.
11096143|NCT01562041|OG000|Outcome|Ranolazine 500 mg|Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days.
11096144|NCT01562041|EG000|Reported Event|Ranolazine 500 mg|Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days.
11096145|NCT01562132|BG000|Baseline|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096146|NCT01562132|BG001|Baseline|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096147|NCT01562132|BG002|Baseline|Total|Total of all reporting groups
11096148|NCT01562132|FG000|Participant Flow|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096149|NCT01562132|FG001|Participant Flow|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096150|NCT01562132|OG000|Outcome|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096151|NCT01562132|OG001|Outcome|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
10833670|NCT00153842|BG000|Baseline|Phase IB|Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin
10833671|NCT00153842|BG001|Baseline|Phase II|Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
10833672|NCT00153842|BG002|Baseline|Total|Total of all reporting groups
10833673|NCT00153842|FG000|Participant Flow|Phase IB|Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin
10833674|NCT00153842|FG001|Participant Flow|Phase II|Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
10833675|NCT00153842|OG000|Outcome|Phase IB: Bexarotene 300mg, Paclitaxel and Carboplatin|Bexarotene 300mg administered with paclitaxel and carboplatin
10833676|NCT00153842|OG001|Outcome|Phase IB: Bexarotene 400mg, Paclitaxel and Carboplatin|Bexarotene 400mg administered with paclitaxel and carboplatin
10833677|NCT00153842|OG002|Outcome|Phase II|Bexarotene 400mg administered with paclitaxel and carboplatin (Paraplatin and weekly Taxol)
10833678|NCT00153842|EG000|Reported Event|Phase IB - Bexarotene 300mg, Paclitaxel and Carboplatin|Bexarotene 300mg administered with paclitaxel and carboplatin
10833679|NCT00153842|EG001|Reported Event|Phase IB - Bexarotene 400mg, Paclitaxel and Carboplatin|Bexarotene 400mg administered with paclitaxel and carboplatin
10833680|NCT00153842|EG002|Reported Event|Phase II|Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
10833681|NCT00153920|BG000|Baseline|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
10833682|NCT00153920|FG000|Participant Flow|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
10833683|NCT00153920|OG000|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
10833684|NCT00153920|EG000|Reported Event|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
10833685|NCT00153985|BG000|Baseline|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
10833686|NCT00153985|FG000|Participant Flow|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
10833687|NCT00153985|OG000|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
10833688|NCT00153985|EG000|Reported Event|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
10833689|NCT00154063|BG000|Baseline|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833690|NCT00154063|BG001|Baseline|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833691|NCT00154063|BG002|Baseline|Total|Total of all reporting groups
10833692|NCT00154063|FG000|Participant Flow|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833693|NCT00154063|FG001|Participant Flow|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833694|NCT00154063|OG000|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833695|NCT00154063|OG001|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833696|NCT00154063|OG002|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833697|NCT00154063|OG003|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833698|NCT00154063|OG000|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833699|NCT00154063|OG001|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833700|NCT00154063|EG000|Reported Event|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833701|NCT00154063|EG001|Reported Event|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
10833702|NCT00154102|BG000|Baseline|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833703|NCT00154102|BG001|Baseline|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833704|NCT00154102|BG002|Baseline|Total|Total of all reporting groups
10833705|NCT00154102|FG000|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833706|NCT00154102|FG001|Participant Flow|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833707|NCT00154102|OG000|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833708|NCT00154102|OG001|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
10833709|NCT00154102|EG000|Reported Event|Cetuximab Plus FOLFIRI|"Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects."
10833710|NCT00154102|EG001|Reported Event|FOLFIRI Alone|"Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects"
10833711|NCT00154284|BG000|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833712|NCT00154284|BG001|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833713|NCT00154284|BG002|Baseline|Total|Total of all reporting groups
10833714|NCT00154284|FG000|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833715|NCT00154284|FG001|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833716|NCT00154284|OG000|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833717|NCT00154284|OG001|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833718|NCT00154284|OG000|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833719|NCT00154284|OG001|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833720|NCT00154284|EG000|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833721|NCT00154284|EG001|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
10833722|NCT00154297|BG000|Baseline|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
10833723|NCT00154297|BG001|Baseline|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
10833724|NCT00154297|BG002|Baseline|Total|Total of all reporting groups
10833725|NCT00154297|FG000|Participant Flow|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
10833726|NCT00154297|FG001|Participant Flow|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
10833727|NCT00154297|OG000|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
10833728|NCT00154297|OG001|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
10833729|NCT00154297|EG000|Reported Event|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
10833730|NCT00154297|EG001|Reported Event|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
10833731|NCT00154310|BG000|Baseline|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
10833732|NCT00154310|BG001|Baseline|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
10833733|NCT00154310|BG002|Baseline|Total|Total of all reporting groups
10833734|NCT00154310|FG000|Participant Flow|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
10833735|NCT00154310|FG001|Participant Flow|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
10833736|NCT00154310|OG000|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
10833737|NCT00154310|OG001|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
10833738|NCT00154310|EG000|Reported Event|Certican|Certican
10833739|NCT00154310|EG001|Reported Event|Sandimmun Optoral|Sandimmun Optoral
10833740|NCT00154375|BG000|Baseline|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
10833741|NCT00154375|BG001|Baseline|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
10833742|NCT00154375|BG002|Baseline|Total|Total of all reporting groups
10833743|NCT00154375|FG000|Participant Flow|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
10833744|NCT00154375|FG001|Participant Flow|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
10833745|NCT00154375|OG000|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
10833746|NCT00154375|OG001|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
10833747|NCT00154375|EG000|Reported Event|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
10833748|NCT00154375|EG001|Reported Event|Period With Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily.
10833749|NCT00154375|EG002|Reported Event|Period After Switch to Combination|After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
10833750|NCT00154466|BG000|Baseline|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833751|NCT00154466|BG001|Baseline|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833752|NCT00154466|BG002|Baseline|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833753|NCT00154466|BG003|Baseline|Total|Total of all reporting groups
10833754|NCT00154466|FG000|Participant Flow|Post-infarction Training|which underwent a 3-month cardiac rehabilitation program
10833755|NCT00154466|FG001|Participant Flow|Post-infarction Nontraining|in which patients continued their usual lifestyle.
10833756|NCT00154466|FG002|Participant Flow|Healthy Controls|For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
10833757|NCT00154466|OG000|Outcome|Post-infarction Training|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
10833758|NCT00154466|OG001|Outcome|Post-infarction Nontraining|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
10833759|NCT00154466|OG000|Outcome|Post-infarction Training|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833760|NCT00154466|OG001|Outcome|Post-infarction Nontraining|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833761|NCT00154466|OG002|Outcome|Healthy Controls|19 age- and sex-matched healthy volunteers
10833762|NCT00154466|EG000|Reported Event|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833763|NCT00154466|EG001|Reported Event|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833764|NCT00154466|EG002|Reported Event|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
10833765|NCT00156013|BG000|Baseline|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
10833766|NCT00156013|FG000|Participant Flow|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
10833767|NCT00156013|OG000|Outcome|Clofarabine|During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
10833768|NCT00156013|OG000|Outcome|Open Label Trial of Clofarabine in Relapsed or Refractory NHL|"Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.~CLOFARABINE: 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles"
10833769|NCT00156013|OG000|Outcome|Toxicity|Myelosuppresion
10833770|NCT00156013|EG000|Reported Event|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
10833771|NCT00156247|BG000|Baseline|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
10833772|NCT00156247|FG000|Participant Flow|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
10833773|NCT00156247|OG000|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
10833774|NCT00156247|EG000|Reported Event|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
10833775|NCT00156390|BG000|Baseline|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
10833776|NCT00156390|BG001|Baseline|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
10833777|NCT00156390|BG002|Baseline|Total|Total of all reporting groups
10833778|NCT00156390|FG000|Participant Flow|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
10833779|NCT00156390|FG001|Participant Flow|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
10833780|NCT00156390|OG000|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
10833781|NCT00156390|OG001|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
10833782|NCT00156390|OG001|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
10833783|NCT00156390|EG000|Reported Event|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
10833784|NCT00156390|EG001|Reported Event|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
10833785|NCT00156533|BG000|Baseline|Placebo|QHS dosing with placebo
10833786|NCT00156533|BG001|Baseline|QHS Zolpidem|QHS dosing with 10mg of zolpidem
10833787|NCT00156533|BG002|Baseline|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
10833788|NCT00156533|BG003|Baseline|CTRL|Monitor only condition.
10833789|NCT00156533|BG004|Baseline|Total|Total of all reporting groups
10833790|NCT00156533|FG000|Participant Flow|Placebo|Once nightly dosing (quaque hora somni [QHS])with placebo
10833791|NCT00156533|FG001|Participant Flow|QHS (Nightly) Zolpidem|Once nightly (QHS) dosing with 10mg of zolpidem
10833792|NCT00156533|FG002|Participant Flow|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
10833793|NCT00156533|FG003|Participant Flow|CTRL|Monitor only condition.
10833794|NCT00156533|OG000|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
10833795|NCT00156533|OG001|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
10833796|NCT00156533|OG002|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
10833797|NCT00156533|OG003|Outcome|CTRL|Monitor only condition (no placebo and no zolpidem).
10833798|NCT00156533|OG002|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
10833799|NCT00156533|OG003|Outcome|CTRL|Monitor only condition.
10833800|NCT00156533|EG000|Reported Event|Placebo|QHS dosing with placebo
10833801|NCT00156533|EG001|Reported Event|QHS Zolpidem|QHS dosing with 10mg of zolpidem
10833802|NCT00156533|EG002|Reported Event|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
10833803|NCT00156533|EG003|Reported Event|CTRL|Monitor only condition.
10833804|NCT00156715|BG000|Baseline|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
10833805|NCT00156715|FG000|Participant Flow|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
10833806|NCT00156715|OG000|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
10833807|NCT00156715|EG000|Reported Event|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
10833808|NCT00156819|BG000|Baseline|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833809|NCT00156819|BG001|Baseline|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833810|NCT00156819|BG002|Baseline|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833811|NCT00156819|BG003|Baseline|Total|Total of all reporting groups
10833812|NCT00156819|FG000|Participant Flow|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833813|NCT00156819|FG001|Participant Flow|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833814|NCT00156819|FG002|Participant Flow|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833815|NCT00156819|OG000|Outcome|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833816|NCT00156819|OG001|Outcome|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833817|NCT00156819|OG002|Outcome|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833818|NCT00156819|EG000|Reported Event|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833819|NCT00156819|EG001|Reported Event|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833820|NCT00156819|EG002|Reported Event|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
10833821|NCT00156910|BG000|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10833822|NCT00156910|BG001|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10833823|NCT00156910|BG002|Baseline|Total|Total of all reporting groups
10833824|NCT00156910|FG000|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10833825|NCT00156910|FG001|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10833826|NCT00156910|OG000|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10833827|NCT00156910|OG001|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10833828|NCT00156910|EG000|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10833829|NCT00156910|EG001|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10833830|NCT00156923|BG000|Baseline|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
10833831|NCT00156923|BG001|Baseline|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
10833832|NCT00156923|BG002|Baseline|Total|Total of all reporting groups
10833833|NCT00156923|FG000|Participant Flow|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
10833834|NCT00156923|FG001|Participant Flow|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
10833835|NCT00156923|OG000|Outcome|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
10833836|NCT00156923|OG001|Outcome|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
10833837|NCT00156923|EG000|Reported Event|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
10833838|NCT00156923|EG001|Reported Event|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
10833839|NCT00156936|BG000|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
10833840|NCT00156936|BG001|Baseline|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
10833841|NCT00156936|BG002|Baseline|Total|Total of all reporting groups
10833842|NCT00156936|FG000|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
10833843|NCT00156936|FG001|Participant Flow|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
10833844|NCT00156936|OG000|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
10833845|NCT00156936|OG001|Outcome|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
10833846|NCT00156936|EG000|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
10833847|NCT00156936|EG001|Reported Event|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
10833848|NCT00157014|BG000|Baseline|Tacrolimus - Adult|Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833849|NCT00157014|BG001|Baseline|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833850|NCT00157014|BG002|Baseline|Tacrolimus - Pediatric|Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833851|NCT00157014|BG003|Baseline|Cyclosporine - Pediatric|Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833852|NCT00157014|BG004|Baseline|Total|Total of all reporting groups
10833853|NCT00157014|FG000|Participant Flow|Tacrolimus - Adult|Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833854|NCT00157014|FG001|Participant Flow|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833855|NCT00157014|FG002|Participant Flow|Tacrolimus - Pediatric|Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833856|NCT00157014|FG003|Participant Flow|Cyclosporine - Pediatric|Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833857|NCT00157014|OG000|Outcome|Tacrolimus - Adult|Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833858|NCT00157014|OG001|Outcome|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833859|NCT00157014|OG000|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833860|NCT00157014|OG001|Outcome|Cyclosporine - Pediatric|Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833861|NCT00157014|EG000|Reported Event|Tacrolimus - Adult|Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833862|NCT00157014|EG001|Reported Event|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
10833863|NCT00157014|EG002|Reported Event|Tacrolimus - Pediatric|Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833864|NCT00157014|EG003|Reported Event|Cyclosporine - Pediatric|Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
10833865|NCT00157157|BG000|Baseline|PUPs|
10833866|NCT00157157|FG000|Participant Flow|Previously Untreated Patients (PUPs)|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on-demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution's standard of care for the type of bleeding episodes diagnosed.
10833867|NCT00157157|OG000|Outcome|PUPs|
10833868|NCT00157157|OG000|Outcome|PUPs -During Prophylaxis|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator]. The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution's standard of care for the type of bleeding episode (BE) diagnosed.
10833869|NCT00157157|OG001|Outcome|PUPs -During On-Demand Treatment|The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution's standard of care for the type of BE diagnosed.
10833870|NCT00157157|OG002|Outcome|PUPs -During Perioperative Management|rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution's standard of care.
10833871|NCT00157157|OG000|Outcome|PUPs -Initial Visit|Incremental recovery at the Initial Study Visit
10833872|NCT00157157|OG001|Outcome|PUPs -Termination Visit|Incremental recovery at the Termination Study Visit
10833873|NCT00157157|OG000|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
10833874|NCT00157157|OG001|Outcome|PUPs - Developed Factor VIII Inhibitor|
10833875|NCT00157157|EG000|Reported Event|PUPs|
10833876|NCT00157196|BG000|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
10833877|NCT00157196|FG000|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
10842829|NCT00249808|EG000|Reported Event|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
10833878|NCT00157196|OG000|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
10833879|NCT00157196|EG000|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
10833880|NCT00157209|BG000|Baseline|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833881|NCT00157209|BG001|Baseline|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833882|NCT00157209|BG002|Baseline|Total|Total of all reporting groups
10833883|NCT00157209|FG000|Participant Flow|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833884|NCT00157209|FG001|Participant Flow|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833885|NCT00157209|OG000|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833886|NCT00157209|OG001|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833887|NCT00157209|EG000|Reported Event|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10833888|NCT00157209|EG001|Reported Event|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
10842830|NCT00249821|BG000|Baseline|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
10833889|NCT00157248|BG000|Baseline|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
10833890|NCT00157248|BG001|Baseline|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
10833891|NCT00157248|BG002|Baseline|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
10833892|NCT00157248|BG003|Baseline|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
10833893|NCT00157248|BG004|Baseline|Total|Total of all reporting groups
10833894|NCT00157248|FG000|Participant Flow|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
10833895|NCT00157248|FG001|Participant Flow|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
10833896|NCT00157248|FG002|Participant Flow|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
10833897|NCT00157248|FG003|Participant Flow|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
10833898|NCT00157248|OG000|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
10833899|NCT00157248|OG001|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
10833900|NCT00157248|OG002|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
10833901|NCT00157248|OG003|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
10833902|NCT00157248|OG004|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
10833903|NCT00157248|OG005|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
10833904|NCT00157248|EG000|Reported Event|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
10833905|NCT00157248|EG001|Reported Event|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
10833906|NCT00157248|EG002|Reported Event|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
10833907|NCT00157248|EG003|Reported Event|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
10833908|NCT00157248|EG004|Reported Event|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
10833909|NCT00157248|EG005|Reported Event|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
10833910|NCT00157573|BG000|Baseline|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
10833911|NCT00157573|FG000|Participant Flow|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
10833912|NCT00157573|FG001|Participant Flow|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and the white blood cell count.
10833913|NCT00157573|OG000|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
10833914|NCT00157573|EG000|Reported Event|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
10833915|NCT00157573|EG001|Reported Event|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.
10833916|NCT00157755|BG000|Baseline|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
10833917|NCT00157755|BG001|Baseline|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
10833918|NCT00157755|BG002|Baseline|Total|Total of all reporting groups
10833919|NCT00157755|FG000|Participant Flow|Diabetic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
10833920|NCT00157755|FG001|Participant Flow|Diabetic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
10833921|NCT00157755|FG002|Participant Flow|Diabetic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
10833922|NCT00157755|FG003|Participant Flow|Idiopathic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
10833923|NCT00157755|FG004|Participant Flow|Idiopathic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
10833924|NCT00157755|FG005|Participant Flow|Idiopathic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.
10833925|NCT00157755|OG000|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
10833926|NCT00157755|OG001|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
10833927|NCT00157755|EG000|Reported Event|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
10833928|NCT00157755|EG001|Reported Event|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
10833929|NCT00157820|BG000|Baseline|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
10833930|NCT00157820|BG001|Baseline|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
10833931|NCT00157820|BG002|Baseline|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
10833932|NCT00157820|BG003|Baseline|Total|Total of all reporting groups
10833933|NCT00157820|FG000|Participant Flow|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
10833934|NCT00157820|FG001|Participant Flow|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
10833935|NCT00157820|FG002|Participant Flow|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
10833936|NCT00157820|OG000|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
10833937|NCT00157820|OG001|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
10833938|NCT00157820|OG002|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm"
10833939|NCT00157820|OG002|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
10833940|NCT00157820|EG000|Reported Event|SC True|Allocated to Single Chamber ICD (SC true arm)
10833941|NCT00157820|EG001|Reported Event|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated
10833942|NCT00157820|EG002|Reported Event|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
10833943|NCT00157950|BG000|Baseline|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
10833944|NCT00157950|BG001|Baseline|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
10833945|NCT00157950|BG002|Baseline|Total|Total of all reporting groups
10833946|NCT00157950|FG000|Participant Flow|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
10833947|NCT00157950|FG001|Participant Flow|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
10833948|NCT00157950|OG000|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
10833949|NCT00157950|OG001|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
10833950|NCT00157950|EG000|Reported Event|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
10833951|NCT00157950|EG001|Reported Event|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
10833952|NCT00158054|BG000|Baseline|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
10833953|NCT00158054|BG001|Baseline|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
10833954|NCT00158054|BG002|Baseline|Total|Total of all reporting groups
10833955|NCT00158054|FG000|Participant Flow|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
10833956|NCT00158054|FG001|Participant Flow|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
10833957|NCT00158054|OG000|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
10833958|NCT00158054|OG001|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
10833959|NCT00158054|EG000|Reported Event|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
10833960|NCT00158054|EG001|Reported Event|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
10833961|NCT00158184|BG000|Baseline|Rx Opioid Abusers|Prescription Opioids users with abusive patterns of use.
10833962|NCT00158184|BG001|Baseline|Rx Opioid Medical Users|Prescription Opioids users without abusive patterns of use.
10833963|NCT00158184|BG002|Baseline|Total|Total of all reporting groups
10833964|NCT00158184|FG000|Participant Flow|Rx Opioid Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.
10833965|NCT00158184|FG001|Participant Flow|Rx Opioid Non-Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.
10833966|NCT00158184|OG000|Outcome|Rx Opioid Abusers|Recreational prescription opioid users.
10833967|NCT00158184|OG001|Outcome|Rx Opioid Non-Abusers|Medical prescription opioid users.
10833968|NCT00158184|OG000|Outcome|Rx Opioid Abusers|Recreation users
10833969|NCT00158184|OG001|Outcome|Rx Opioid Non-Abusers|Medical users
10833970|NCT00158184|EG000|Reported Event|Rx Opioid Abusers|
10833971|NCT00158184|EG001|Reported Event|Rx Opioid Non-Abusers|
10833972|NCT00158197|BG000|Baseline|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833973|NCT00158197|BG001|Baseline|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833974|NCT00158197|BG002|Baseline|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833975|NCT00158197|BG003|Baseline|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
10833976|NCT00158197|BG004|Baseline|Total|Total of all reporting groups
10833977|NCT00158197|FG000|Participant Flow|Intermittent Predictable Schedule|"Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833978|NCT00158197|FG001|Participant Flow|Continuous Schedule|"Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10842831|NCT00249821|BG001|Baseline|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
10842832|NCT00249821|BG002|Baseline|Total|Total of all reporting groups
10842833|NCT00249821|FG000|Participant Flow|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
11096152|NCT01562132|EG000|Reported Event|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096153|NCT01562132|EG001|Reported Event|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
11096154|NCT01562275|BG000|Baseline|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096155|NCT01562275|BG001|Baseline|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096156|NCT01562275|BG002|Baseline|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096157|NCT01562275|BG003|Baseline|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096158|NCT01562275|BG004|Baseline|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096159|NCT01562275|BG005|Baseline|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096160|NCT01562275|BG006|Baseline|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096161|NCT01562275|BG007|Baseline|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096162|NCT01562275|BG008|Baseline|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096163|NCT01562275|BG009|Baseline|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096164|NCT01562275|BG010|Baseline|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096165|NCT01562275|BG011|Baseline|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096166|NCT01562275|BG012|Baseline|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096167|NCT01562275|BG013|Baseline|Total|Total of all reporting groups
11096168|NCT01562275|FG000|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 milligrams (mg) cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096169|NCT01562275|FG001|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096170|NCT01562275|FG002|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
10833979|NCT00158197|FG002|Participant Flow|Intermittent Unpredictable Schedule|"Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833980|NCT00158197|FG003|Participant Flow|Standard|Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
10833981|NCT00158197|OG000|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833982|NCT00158197|OG001|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833983|NCT00158197|OG002|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
10833984|NCT00158197|OG003|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
10833985|NCT00158197|EG000|Reported Event|Continuous Voucher Schedule|Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
10833986|NCT00158197|EG001|Reported Event|Intermittent Predictable Schedule|Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
10833987|NCT00158197|EG002|Reported Event|Intermittent Unpredictable Schedule|Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
10833988|NCT00158197|EG003|Reported Event|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
10833989|NCT00158223|BG000|Baseline|Placebo|Participants received encapsulated placebo made to match active drug
10833990|NCT00158223|BG001|Baseline|Pimozide|Participants received pimozide flexible dosing
10833991|NCT00158223|BG002|Baseline|Total|Total of all reporting groups
10833992|NCT00158223|FG000|Participant Flow|Placebo|Participants received encapsulated placebo made to match active drug
11096171|NCT01562275|FG003|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096172|NCT01562275|FG004|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096173|NCT01562275|FG005|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096174|NCT01562275|FG006|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096175|NCT01562275|FG007|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096176|NCT01562275|FG008|Participant Flow|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096177|NCT01562275|FG009|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096178|NCT01562275|FG010|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096179|NCT01562275|FG011|Participant Flow|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096180|NCT01562275|FG012|Participant Flow|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096181|NCT01562275|OG000|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096182|NCT01562275|OG001|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096183|NCT01562275|OG002|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096184|NCT01562275|OG003|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096185|NCT01562275|OG004|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096186|NCT01562275|OG005|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096187|NCT01562275|OG006|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096188|NCT01562275|OG007|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096189|NCT01562275|OG008|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096190|NCT01562275|OG009|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096191|NCT01562275|OG010|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096192|NCT01562275|OG000|Outcome|Stage 1 DECs|During Stage 1, participants received cobimetinib and ipatasertib combination doses either under Arm A (21/7 dosing schedule [cobimetinib and ipatasertib taken concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days]) or under Arm B (intermittent cobimetinib dosing schedule [ipatasertib taken once daily on Days 1-21 consecutively with concurrent dosing of cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days)] until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096193|NCT01562275|OG000|Outcome|DECs and Expansion Cohorts|Included all participants who were treated under Stage 1 (Dose Escalation Cohorts) and Stage 2 (Dose Expansion Cohorts).
11096194|NCT01562275|OG011|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096195|NCT01562275|OG012|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096196|NCT01562275|EG000|Reported Event|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096197|NCT01562275|EG001|Reported Event|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096198|NCT01562275|EG002|Reported Event|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096199|NCT01562275|EG003|Reported Event|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096200|NCT01562275|EG004|Reported Event|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096201|NCT01562275|EG005|Reported Event|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096202|NCT01562275|EG006|Reported Event|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096203|NCT01562275|EG007|Reported Event|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096204|NCT01562275|EG008|Reported Event|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096205|NCT01562275|EG009|Reported Event|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096206|NCT01562275|EG010|Reported Event|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096207|NCT01562275|EG011|Reported Event|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096208|NCT01562275|EG012|Reported Event|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
11096209|NCT01562314|BG000|Baseline|GWP42003|GWP42003 was administered orally at a dose of 50 mg up to 250 mg, BID, in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week.
11096210|NCT01562314|BG001|Baseline|Placebo|Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week.
11096211|NCT01562314|BG002|Baseline|Total|Total of all reporting groups
11096212|NCT01562314|FG000|Participant Flow|GWP42003|GWP42003 was administered orally at a dose of 50 milligram (mg) up to 250 mg, twice daily (BID), in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week.
11096213|NCT01562314|FG001|Participant Flow|Placebo|Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week.
11096214|NCT01562314|OG000|Outcome|GWP42003|GWP42003 was administered orally at a dose of 50 mg up to 250 mg, BID, in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week.
11096215|NCT01562314|OG001|Outcome|Placebo|Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week.
11096216|NCT01562314|EG000|Reported Event|GWP42003|GWP42003 was administered orally at a dose of 50 mg up to 250 mg, BID, in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week.
11096217|NCT01562314|EG001|Reported Event|Placebo|Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week.
11096218|NCT01562327|BG000|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
11096219|NCT01562327|FG000|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
11096220|NCT01562327|OG000|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
11096221|NCT01562327|OG000|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
11096222|NCT01562327|EG000|Reported Event|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
11096223|NCT01562379|BG000|Baseline|No Food|A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
11096224|NCT01562379|BG001|Baseline|Plumpy Doz|"In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.~Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals."
11096225|NCT01562379|BG002|Baseline|Wheat Soy Blend (WSB++)|"Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.~Wheat Soy Blend (WSB++): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals."
11096226|NCT01562379|BG003|Baseline|Chickpea Based Complementary Food Supplement|"Children will receive a Chickpea based complementary food supplement to be consumed daily.~Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals."
11096227|NCT01562379|BG004|Baseline|Rice Based Complementary Food Supplement|"Children will receive a locally developed rice based complementary food supplement.~Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals."
11096228|NCT01562379|BG005|Baseline|Total|Total of all reporting groups
11096229|NCT01562379|FG000|Participant Flow|No Food|A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
11096230|NCT01562379|FG001|Participant Flow|Plumpy Doz|"In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.~Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals."
11096231|NCT01562379|FG002|Participant Flow|Wheat Soy Blend (WSB++)|"Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.~Wheat Soy Blend (WSB++): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals."
11096232|NCT01562379|FG003|Participant Flow|Chickpea Based Complementary Food Supplement|"Children will receive a Chickpea based complementary food supplement to be consumed daily.~Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals."
11096233|NCT01562379|FG004|Participant Flow|Rice Based Complementary Food Supplement|"Children will receive a locally developed rice based complementary food supplement.~Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals."
11096234|NCT01562379|OG000|Outcome|No Food|A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
11096235|NCT01562379|OG001|Outcome|Plumpy Doz|"In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.~Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals."
11096236|NCT01562379|OG002|Outcome|Wheat Soy Blend (WSB++)|"Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.~Wheat Soy Blend (WSB++): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals."
11096237|NCT01562379|OG003|Outcome|Chickpea Based Complementary Food Supplement|"Children will receive a Chickpea based complementary food supplement to be consumed daily.~Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals."
11096238|NCT01562379|OG004|Outcome|Rice Based Complementary Food Supplement|"Children will receive a locally developed rice based complementary food supplement.~Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals."
11096239|NCT01562379|EG000|Reported Event|No Food|A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
11096240|NCT01562379|EG001|Reported Event|Plumpy Doz|"In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.~Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals."
11096241|NCT01562379|EG002|Reported Event|Wheat Soy Blend (WSB++)|"Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.~Wheat Soy Blend (WSB++): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals."
11096242|NCT01562379|EG003|Reported Event|Chickpea Based Complementary Food Supplement|"Children will receive a Chickpea based complementary food supplement to be consumed daily.~Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals."
11096243|NCT01562379|EG004|Reported Event|Rice Based Complementary Food Supplement|"Children will receive a locally developed rice based complementary food supplement.~Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals."
11096244|NCT01562444|BG000|Baseline|TBE_R Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
11096245|NCT01562444|BG001|Baseline|TBE_C Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096246|NCT01562444|BG002|Baseline|TBE_AC Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096247|NCT01562444|BG003|Baseline|Total|Total of all reporting groups
11096248|NCT01562444|FG000|Participant Flow|TBE_R Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
11096249|NCT01562444|FG001|Participant Flow|TBE_C Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096250|NCT01562444|FG002|Participant Flow|TBE_AC Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096251|NCT01562444|OG000|Outcome|TBE_R Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
11096252|NCT01562444|OG001|Outcome|TBE_C Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096253|NCT01562444|OG002|Outcome|TBE_AC Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096254|NCT01562444|EG000|Reported Event|TBE_R Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
11096255|NCT01562444|EG001|Reported Event|TBE_C Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096256|NCT01562444|EG002|Reported Event|TBE_AC Group|Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
11096257|NCT01562548|BG000|Baseline|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
11096258|NCT01562548|BG001|Baseline|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
11096259|NCT01562548|BG002|Baseline|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096260|NCT01562548|BG003|Baseline|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096261|NCT01562548|BG004|Baseline|Total|Total of all reporting groups
11096262|NCT01562548|FG000|Participant Flow|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
11096263|NCT01562548|FG001|Participant Flow|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
11096264|NCT01562548|FG002|Participant Flow|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096265|NCT01562548|FG003|Participant Flow|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096266|NCT01562548|OG000|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
11096267|NCT01562548|OG001|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days
11096268|NCT01562548|OG002|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096269|NCT01562548|OG003|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
10833993|NCT00158223|FG001|Participant Flow|Pimozide|Participants received pimozide flexible dosing
10833994|NCT00158223|OG000|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
10833995|NCT00158223|OG001|Outcome|Pimozide|Participants received pimozide flexible dosing
10833996|NCT00158223|EG000|Reported Event|Placebo|Participants received encapsulated placebo made to match active drug
10833997|NCT00158223|EG001|Reported Event|Pimozide|Participants received pimozide flexible dosing
10833998|NCT00158249|BG000|Baseline|Placebo|"matched capsules~placebo: matched for physical appearance"
10833999|NCT00158249|BG001|Baseline|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
10834000|NCT00158249|BG002|Baseline|Total|Total of all reporting groups
10834001|NCT00158249|FG000|Participant Flow|Placebo|"matched capsules~placebo: matched for physical appearance"
10834002|NCT00158249|FG001|Participant Flow|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
10834003|NCT00158249|OG000|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
10834004|NCT00158249|OG001|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
10834005|NCT00158249|EG000|Reported Event|Placebo|"matched capsules~placebo: matched for physical appearance"
10834006|NCT00158249|EG001|Reported Event|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
10834007|NCT00158262|BG000|Baseline|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834008|NCT00158262|BG001|Baseline|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834009|NCT00158262|BG002|Baseline|Total|Total of all reporting groups
10834010|NCT00158262|FG000|Participant Flow|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834011|NCT00158262|FG001|Participant Flow|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834012|NCT00158262|OG000|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834013|NCT00158262|OG001|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834014|NCT00158262|EG000|Reported Event|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
11096270|NCT01562548|OG001|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
11096271|NCT01562548|OG003|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
10834015|NCT00158262|EG001|Reported Event|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
10834016|NCT00158379|BG000|Baseline|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
10834017|NCT00158379|FG000|Participant Flow|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
10834018|NCT00158379|OG000|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
10834019|NCT00158379|EG000|Reported Event|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
10834020|NCT00158600|BG000|Baseline|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
10834021|NCT00158600|BG001|Baseline|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
11096272|NCT01562548|EG000|Reported Event|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
11096273|NCT01562548|EG001|Reported Event|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
11096274|NCT01562548|EG002|Reported Event|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096275|NCT01562548|EG003|Reported Event|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
11096276|NCT01562613|BG000|Baseline|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
11096277|NCT01562613|FG000|Participant Flow|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
11096278|NCT01562613|OG000|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
11096279|NCT01562613|EG000|Reported Event|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
11096280|NCT01562678|BG000|Baseline|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
11096281|NCT01562678|BG001|Baseline|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
11096282|NCT01562678|BG002|Baseline|Total|Total of all reporting groups
11096283|NCT01562678|FG000|Participant Flow|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
11096284|NCT01562678|FG001|Participant Flow|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
11096285|NCT01562678|OG000|Outcome|Liraglutide|Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).
11096286|NCT01562678|OG001|Outcome|Placebo|Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
11096287|NCT01562678|EG000|Reported Event|Liraglutide|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
11096288|NCT01562678|EG001|Reported Event|Placebo|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
11096289|NCT01562743|BG000|Baseline|SPM 962|Rotigotine transdermal patch
11096290|NCT01562743|FG000|Participant Flow|SPM 962|"Rotigotine transdermal patch~A patch containing 2.25 - 6.75mg of rotigotine was administered once a day."
11096291|NCT01562743|OG000|Outcome|SPM 962|Rotigotine transdermal patch
11096292|NCT01562743|EG000|Reported Event|SPM 962|Rotigotine transdermal patch
11096293|NCT01562756|BG000|Baseline|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
11096294|NCT01562756|FG000|Participant Flow|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
11096295|NCT01562756|OG000|Outcome|Feasibility Outcomes|The feasibility outcomes (Primary outcomes 1 & 2) for this study include participant recruitment, enrollment, and the duration of the study.
11096296|NCT01562756|EG000|Reported Event|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude spinal manipulation"
11096297|NCT01562782|BG000|Baseline|Caucasian|"Control group: The arm is an oral sugar challenge with blood sampling over 4 hours.~Fructose + Glucose Beverage: Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage."
11096298|NCT01562782|BG001|Baseline|South Asians|"Experimental group: The arm is an oral sugar challenge with blood sampling over 4 hours.~Fructose + Glucose Beverage: Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage."
11096299|NCT01562782|BG002|Baseline|Total|Total of all reporting groups
11096300|NCT01562782|FG000|Participant Flow|Caucasians|"Control group: The arm is an oral sugar challenge with blood sampling over 4 hours.~Fructose + Glucose Beverage: Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage."
11096301|NCT01562782|FG001|Participant Flow|South Asians|"South Asian group: The arm is an oral sugar challenge with blood sampling over 4 hours.~Fructose + Glucose Beverage: Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage."
11096302|NCT01562782|OG000|Outcome|Caucasians|Caucasian control group
11096303|NCT01562782|OG001|Outcome|South Asians|South Asian experimental group
11096304|NCT01562782|EG000|Reported Event|Caucasians|Caucasian control group
11096305|NCT01562782|EG001|Reported Event|South Asians|South Asian experimental group
11096306|NCT01562873|BG000|Baseline|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
10834022|NCT00158600|BG002|Baseline|Total|Total of all reporting groups
10834023|NCT00158600|FG000|Participant Flow|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
10834024|NCT00158600|FG001|Participant Flow|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
10834025|NCT00158600|OG000|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
10834026|NCT00158600|OG001|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
10834027|NCT00158600|EG000|Reported Event|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
10834028|NCT00158600|EG001|Reported Event|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
10834029|NCT00158600|EG002|Reported Event|Overall|
10834030|NCT00158743|BG000|Baseline|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
10834031|NCT00158743|BG001|Baseline|Placebo|sodium chloride placebo
10834032|NCT00158743|BG002|Baseline|Total|Total of all reporting groups
10834033|NCT00158743|FG000|Participant Flow|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
10834034|NCT00158743|FG001|Participant Flow|Placebo|sodium chloride placebo
10834035|NCT00158743|OG000|Outcome|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
10834036|NCT00158743|OG001|Outcome|Placebo|sodium chloride placebo
10834037|NCT00158743|EG000|Reported Event|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
10834038|NCT00158743|EG001|Reported Event|Placebo|sodium chloride placebo
10834039|NCT00158756|BG000|Baseline|Tritanrix-HepB+Rotarix Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834040|NCT00158756|BG001|Baseline|Tritanrix-HepB+Placebo Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834041|NCT00158756|BG002|Baseline|Zilbrix+Rotarix Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834042|NCT00158756|BG003|Baseline|Zilbrix+Placebo Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834043|NCT00158756|BG004|Baseline|Triple Antigen+Engerix-B Group|Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
10834044|NCT00158756|BG005|Baseline|Total|Total of all reporting groups
10834045|NCT00158756|FG000|Participant Flow|Tritanrix-HepB+Rotarix Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834046|NCT00158756|FG001|Participant Flow|Tritanrix-HepB+Placebo Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834047|NCT00158756|FG002|Participant Flow|Zilbrix+Rotarix Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834048|NCT00158756|FG003|Participant Flow|Zilbrix+Placebo Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834049|NCT00158756|FG004|Participant Flow|Triple Antigen+Engerix-B Group|Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
10834050|NCT00158756|OG000|Outcome|Tritanrix-HepB+Rotarix Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834051|NCT00158756|OG001|Outcome|Tritanrix-HepB+Placebo Group|Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834052|NCT00158756|OG002|Outcome|Zilbrix+Rotarix Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
10834053|NCT00158756|OG003|Outcome|Zilbrix+Placebo Group|Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
10834054|NCT00158756|OG004|Outcome|Triple Antigen+Engerix-B Group|Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
10842834|NCT00249821|FG001|Participant Flow|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
10842835|NCT00249821|OG000|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
11096307|NCT01562873|FG000|Participant Flow|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
11096308|NCT01562873|FG001|Participant Flow|Ruxolitinib-Cohort B|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
11096309|NCT01562873|OG000|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
11096310|NCT01562873|EG000|Reported Event|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
11096311|NCT01562886|BG000|Baseline|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
11096312|NCT01562886|FG000|Participant Flow|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
11096313|NCT01562886|OG000|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
11096314|NCT01562886|EG000|Reported Event|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 26mg"
11096315|NCT01563003|BG000|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
11096316|NCT01563003|BG001|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11096317|NCT01563003|BG002|Baseline|Total|Total of all reporting groups
11096318|NCT01563003|FG000|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
11096319|NCT01563003|FG001|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11096320|NCT01563003|OG000|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
11096321|NCT01563003|OG001|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
10834055|NCT00158756|EG000|Reported Event|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
10834056|NCT00158756|EG001|Reported Event|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
10834057|NCT00158756|EG002|Reported Event|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
10834058|NCT00158756|EG003|Reported Event|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
10834059|NCT00158756|EG004|Reported Event|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
10834060|NCT00158860|BG000|Baseline|Placebo|Participants randomized to this treatment arm received matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834061|NCT00158860|BG001|Baseline|Valaciclovir 1g QD|Participants received double blinded treatment of oral dose of valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500mg BID for 3 days after which the double-blind therapy was resumed.
10834062|NCT00158860|BG002|Baseline|Total|Total of all reporting groups
10834063|NCT00158860|FG000|Participant Flow|Placebo|Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg twice a day (BID) for 3 days after which the double-blind therapy was resumed.
10834064|NCT00158860|FG001|Participant Flow|Valaciclovir 1g QD|Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834065|NCT00158860|OG000|Outcome|Placebo|Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834066|NCT00158860|OG001|Outcome|Valaciclovir 1g QD|Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834067|NCT00158860|OG000|Outcome|Placebo|Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834068|NCT00158860|EG000|Reported Event|Placebo|Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834069|NCT00158860|EG001|Reported Event|Valaciclovir 1g QD|Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
10834070|NCT00158925|BG000|Baseline|EASYTRAK EPI Lead|"Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.~EASYTRAK EPI lead: EASYTRAK EPI lead"
10834071|NCT00158925|FG000|Participant Flow|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
10834072|NCT00158925|OG000|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
10834073|NCT00158925|EG000|Reported Event|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
10834074|NCT00159250|BG000|Baseline|Low Dose AVI-4658|"Low dose of AVI-4658~0.09 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834075|NCT00159250|BG001|Baseline|High Dose AVI-4658|"High dose of AVI-4658~0.9 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834076|NCT00159250|BG002|Baseline|Total|Total of all reporting groups
10834077|NCT00159250|FG000|Participant Flow|Low Dose AVI-4658|"Low dose of AVI-4658~0.09 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834078|NCT00159250|FG001|Participant Flow|High Dose AVI-4658|"High dose of AVI-4658~0.9 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834079|NCT00159250|OG000|Outcome|Low Dose AVI-4658|"Low dose of AVI-4658~0.09 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834080|NCT00159250|OG001|Outcome|High Dose AVI-4658|"High dose of AVI-4658~0.9 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
11096322|NCT01563003|EG000|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
11096323|NCT01563003|EG001|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
11096324|NCT01563029|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096325|NCT01563029|BG001|Baseline|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096326|NCT01563029|BG002|Baseline|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096327|NCT01563029|BG003|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096328|NCT01563029|BG004|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096329|NCT01563029|BG005|Baseline|Total|Total of all reporting groups
11096330|NCT01563029|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096331|NCT01563029|FG001|Participant Flow|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096332|NCT01563029|FG002|Participant Flow|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096333|NCT01563029|FG003|Participant Flow|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096334|NCT01563029|FG004|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096335|NCT01563029|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096336|NCT01563029|OG001|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096337|NCT01563029|OG002|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096338|NCT01563029|OG003|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096339|NCT01563029|OG004|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096340|NCT01563029|OG005|Outcome|Average of FF 50 µg OD and FF 100 µg OD|All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096341|NCT01563029|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096342|NCT01563029|EG001|Reported Event|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096343|NCT01563029|EG002|Reported Event|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096344|NCT01563029|EG003|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096345|NCT01563029|EG004|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
11096346|NCT01563055|BG000|Baseline|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11096347|NCT01563055|FG000|Participant Flow|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11096348|NCT01563055|OG000|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11096349|NCT01563055|OG000|Outcome|Overall Study Arm|ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11328380|NCT03426995|OG004|Outcome|Part A: GSK3358699 25 mg SD|Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
11096350|NCT01563055|OG000|Outcome|Ofatumumab +Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11096351|NCT01563055|OG000|Outcome|Overall Study Arm|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
11096352|NCT01563055|EG000|Reported Event|Ofatumumab+Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
11096353|NCT01563081|BG000|Baseline|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
11096354|NCT01563081|BG001|Baseline|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
11096355|NCT01563081|BG002|Baseline|Total|Total of all reporting groups
11096356|NCT01563081|FG000|Participant Flow|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
11096357|NCT01563081|FG001|Participant Flow|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
11096358|NCT01563081|OG000|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
11096359|NCT01563081|OG001|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
11096360|NCT01563081|OG002|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
11096361|NCT01563081|OG000|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
11096362|NCT01563081|OG000|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
11096363|NCT01563081|EG000|Reported Event|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
11096364|NCT01563081|EG001|Reported Event|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
11096365|NCT01563081|EG002|Reported Event|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
11328381|NCT03426995|OG005|Outcome|Part A: GSK3358699 30 mg SD|Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
11328382|NCT03426995|OG006|Outcome|Part A: GSK3358699 40 mg SD|Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
11096366|NCT01563172|BG000|Baseline|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
11096367|NCT01563172|FG000|Participant Flow|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
11096368|NCT01563172|OG000|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
11096369|NCT01563172|OG001|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
11096370|NCT01563172|OG000|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
11096371|NCT01563172|OG001|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
11096372|NCT01563172|OG000|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice
11096373|NCT01563172|OG001|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
11096374|NCT01563172|OG000|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
11096375|NCT01563172|OG001|Outcome|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
11096376|NCT01563172|EG000|Reported Event|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
11096377|NCT01563172|EG001|Reported Event|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
11096378|NCT01563172|EG002|Reported Event|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
11096379|NCT01563172|EG003|Reported Event|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
11096380|NCT01563172|EG004|Reported Event|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice.
11096381|NCT01563185|BG000|Baseline|DUEXIS|"800 mg ibuprofen/26.6 mg famotidine~800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day"
11096382|NCT01563185|FG000|Participant Flow|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
11096383|NCT01563185|OG000|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
11096384|NCT01563185|EG000|Reported Event|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
11218026|NCT02318602|OG002|Outcome|Adolescents|"Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218027|NCT02318602|OG003|Outcome|All Participants|All participants who participated in the study.
11218028|NCT02318602|OG000|Outcome|Infants|"Participants 1 to<2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218029|NCT02318602|OG002|Outcome|Adolescents|"Participants 12 to <17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11096385|NCT01563198|BG000|Baseline|Comfort Talk® Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11096386|NCT01563198|FG000|Participant Flow|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11096387|NCT01563198|OG000|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11096388|NCT01563198|EG000|Reported Event|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
11096389|NCT01563237|BG000|Baseline|MIDI Arrow|Implantation of MIDI Arrow (MicroShunt) in the anterior chamber of the eye in patients with primary open angle glaucoma (POAG)
11096390|NCT01563237|FG000|Participant Flow|First Studied Eye|Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
11096391|NCT01563237|FG001|Participant Flow|Second Studied Eye|Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
11096392|NCT01563237|OG000|Outcome|Success With Respect to IOP|The rates of success reflected sustained control of IOP
11096393|NCT01563237|OG000|Outcome|IOP Change From Baseline|Change of IOP relative to the pre-operative value
11096394|NCT01563237|EG000|Reported Event|Study Eyes Selected to be Operated Within the Study|Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
11096395|NCT01563354|BG000|Baseline|Pasireotide LAR|Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
11096396|NCT01563354|BG001|Baseline|Everolimus|Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
11096397|NCT01563354|BG002|Baseline|Pasireotide LAR and Everolimus Combination|Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
11096398|NCT01563354|BG003|Baseline|Total|Total of all reporting groups
11096399|NCT01563354|FG000|Participant Flow|Pasireotide LAR|Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
11096400|NCT01563354|FG001|Participant Flow|Everolimus|Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
11096401|NCT01563354|FG002|Participant Flow|Pasireotide LAR and Everolimus Combination|Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
11096402|NCT01563354|OG000|Outcome|Pasireotide LAR|Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
11096403|NCT01563354|OG001|Outcome|Everolimus|Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
11096404|NCT01563354|OG002|Outcome|Pasireotide LAR and Everolimus Combination|Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
11096405|NCT01563354|EG000|Reported Event|Pasireotide LAR|Pasireotide LAR
11096406|NCT01563354|EG001|Reported Event|Everolimus|Everolimus
11096407|NCT01563354|EG002|Reported Event|Pasireotide LAR and Everolimus Combination|Pasireotide LAR and Everolimus Combination
11096408|NCT01563406|BG000|Baseline|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
11096409|NCT01563406|BG001|Baseline|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
11096410|NCT01563406|BG002|Baseline|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
11096411|NCT01563406|BG003|Baseline|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
11096412|NCT01563406|BG004|Baseline|Total|Total of all reporting groups
11096413|NCT01563406|FG000|Participant Flow|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
11096414|NCT01563406|FG001|Participant Flow|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
11096415|NCT01563406|FG002|Participant Flow|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
11096416|NCT01563406|FG003|Participant Flow|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
11096417|NCT01563406|OG000|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
11096418|NCT01563406|OG001|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
11096419|NCT01563406|OG002|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
11096420|NCT01563406|OG003|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
11096421|NCT01563406|OG000|Outcome|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
11096422|NCT01563406|OG001|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
11096423|NCT01563406|OG002|Outcome|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
11096424|NCT01563406|OG003|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
11096425|NCT01563406|EG000|Reported Event|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
11096426|NCT01563406|EG001|Reported Event|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
11096427|NCT01563406|EG002|Reported Event|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
11096428|NCT01563406|EG003|Reported Event|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
11096429|NCT01563536|BG000|Baseline|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096430|NCT01563536|BG001|Baseline|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096431|NCT01563536|BG002|Baseline|Total|Total of all reporting groups
11096432|NCT01563536|FG000|Participant Flow|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096433|NCT01563536|FG001|Participant Flow|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096434|NCT01563536|OG000|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096435|NCT01563536|OG001|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096436|NCT01563536|EG000|Reported Event|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096437|NCT01563536|EG001|Reported Event|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
11096438|NCT01563913|BG000|Baseline|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
11096439|NCT01563913|BG001|Baseline|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
11096440|NCT01563913|BG002|Baseline|Total|Total of all reporting groups
11096441|NCT01563913|FG000|Participant Flow|Docosahexaenoic Acid (DHA)|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
11096442|NCT01563913|FG001|Participant Flow|Placebo|Placebo: Sugar Pill, taken for 1.5 years
11096443|NCT01563913|OG000|Outcome|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
11096444|NCT01563913|OG001|Outcome|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
11096445|NCT01563913|EG000|Reported Event|Docosahexaenoic Acid|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
11096446|NCT01563913|EG001|Reported Event|Placebo:|Placebo: Sugar Pill, taken for 1.5 years
11096447|NCT01563978|BG000|Baseline|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
11096448|NCT01563978|BG001|Baseline|PLACEBO|Oral treatment
11096449|NCT01563978|BG002|Baseline|Total|Total of all reporting groups
11096450|NCT01563978|FG000|Participant Flow|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
11096451|NCT01563978|FG001|Participant Flow|PLACEBO|Oral treatment
11096452|NCT01563978|OG000|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
11096453|NCT01563978|OG001|Outcome|PLACEBO|Oral treatment
11096454|NCT01563978|EG000|Reported Event|FOSTA 100 MG BID|
11096455|NCT01563978|EG001|Reported Event|PLACEBO|
11096456|NCT01564277|BG000|Baseline|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096457|NCT01564277|BG001|Baseline|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096458|NCT01564277|BG002|Baseline|Total|Total of all reporting groups
11096459|NCT01564277|FG000|Participant Flow|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096460|NCT01564277|FG001|Participant Flow|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096461|NCT01564277|OG000|Outcome|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096462|NCT01564277|OG001|Outcome|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096463|NCT01564277|EG000|Reported Event|Arm I (1.5mg Rasburicase)|"Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096464|NCT01564277|EG001|Reported Event|Arm II (3 mg Rasburicase)|"Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.~rasburicase: Given IV~allopurinol: Given PO"
11096465|NCT01564394|BG000|Baseline|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
11096466|NCT01564394|BG001|Baseline|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
11096467|NCT01564394|BG002|Baseline|Total|Total of all reporting groups
11096468|NCT01564394|FG000|Participant Flow|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
11096469|NCT01564394|FG001|Participant Flow|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
11096470|NCT01564394|OG000|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
11096471|NCT01564394|OG001|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
11328383|NCT03426995|OG000|Outcome|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
10834081|NCT00159250|EG000|Reported Event|Low Dose AVI-4658|"Low dose of AVI-4658~0.09 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834082|NCT00159250|EG001|Reported Event|High Dose AVI-4658|"High dose of AVI-4658~0.9 mg doses were diluted in 900 μL normal saline (0·9%) and injected to the extensor digitorum brevis (EDB) muscle"
10834083|NCT00159263|BG000|Baseline|Overall Study|Crossover study, same volunteers in all arm, received the following interventions: formoterol, Budesonide low and high dose, or combination of these
10834084|NCT00159263|FG000|Participant Flow|Placebo|first intervention is placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
10834085|NCT00159263|FG001|Participant Flow|Formoterol|First intervention is formoterol, then placebo, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
10834086|NCT00159263|FG002|Participant Flow|Budesonide Low Dose|First intervention is Budesonide low dose, then placebo, then Formoterol, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
10834087|NCT00159263|FG003|Participant Flow|Budesonide High Dose|First intervention is Budesonide high dose, then placebo, then Formoterol, then Budesonide low dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
10834088|NCT00159263|FG004|Participant Flow|Budesonide/Formoterol Single|First intervention is Budesonide/Formoterol single, then placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol double
10834089|NCT00159263|FG005|Participant Flow|Budesonide/Formoterol Double|First intervention is Budesonide/Formoterol double, then placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single
10834090|NCT00159263|OG000|Outcome|Placebo|"placebo~Placebos: Dry powder inhaler"
10834091|NCT00159263|OG001|Outcome|Formoterol|"Oxis(®) 12 μg~Formoterol Inhalant Powder: 12ug"
10834092|NCT00159263|OG002|Outcome|Budesonide Low Dose|"Pulmicort(®) 200 μg~Budesonide Powder: Inhaler"
10834093|NCT00159263|OG003|Outcome|Budesonide High Dose|"Pulmicort(®) 800 μg~Budesonide Powder: Inhaler"
10834094|NCT00159263|OG004|Outcome|Budesonide/Formoterol Combination Single|"single 100/6 μg SYM100~Budesonide and Formoterol Product: Combination Inhaler, Symbicort"
10834095|NCT00159263|OG005|Outcome|Budesonide/Formoterol Combination Double|"double 200/12 μg SYM200~Budesonide and Formoterol Product: Combination Inhaler, Symbicort"
10834096|NCT00159263|EG000|Reported Event|Placebo|Patients who received placebo treatment
10834097|NCT00159263|EG001|Reported Event|Formoterol|Patients who received Formoterol treatment
10834098|NCT00159263|EG002|Reported Event|Budesonide Low Dose|Patients who received Budesonide low dose treatment
10834099|NCT00159263|EG003|Reported Event|Budesonide High Dose|Patients who received Budesonide high dose treatment
10834100|NCT00159263|EG004|Reported Event|Budesonide/Formoterol Single|Patients who received Budesonide/Formoterol single dose treatment
10834101|NCT00159263|EG005|Reported Event|Budesonide/Formoterol Double|Patients who received Budesonide/Formoterol double dose treatment
10834102|NCT00159419|BG000|Baseline|Pamidronate Treatment|
10834103|NCT00159419|BG001|Baseline|Alendronate Treatment|
10834104|NCT00159419|BG002|Baseline|Total|Total of all reporting groups
10834105|NCT00159419|FG000|Participant Flow|Pamidronate Treatment|
10834106|NCT00159419|FG001|Participant Flow|Alendronate Treatment|
10834107|NCT00159419|OG000|Outcome|Pamidronate Treatment|
10834108|NCT00159419|OG001|Outcome|Alendronate|
10834109|NCT00159419|EG000|Reported Event|Pamidronate Treatment|Acute phase reaction with infusion
10834110|NCT00159419|EG001|Reported Event|Alendronate Treatment|
10834111|NCT00159432|BG000|Baseline|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
10834112|NCT00159432|FG000|Participant Flow|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
10834113|NCT00159432|OG000|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
10834114|NCT00159432|EG000|Reported Event|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
10834115|NCT00159822|BG000|Baseline|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator's clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
10834116|NCT00159822|FG000|Participant Flow|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator's clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
10834117|NCT00159822|OG000|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator's clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
10842836|NCT00249821|OG001|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
11096472|NCT01564394|EG000|Reported Event|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
11096473|NCT01564394|EG001|Reported Event|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
11096474|NCT01564407|BG000|Baseline|No Injection|Empty safety control, no injection
11096475|NCT01564407|BG001|Baseline|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
11096476|NCT01564407|BG002|Baseline|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
11096477|NCT01564407|BG003|Baseline|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
11096478|NCT01564407|BG004|Baseline|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
11096479|NCT01564407|BG005|Baseline|Total|Total of all reporting groups
11096480|NCT01564407|FG000|Participant Flow|No Injection|Safety cohort. 4 subjects received empty control. No injection
11096481|NCT01564407|FG001|Participant Flow|Vehicle Only|Vehicle only (0.5 ml of solution)
11096482|NCT01564407|FG002|Participant Flow|Single Admin Drug Day 0|Single administration of study drug on day 0
11096483|NCT01564407|FG003|Participant Flow|Single Admin Drug Day 28|Single administration on Day 28
11096484|NCT01564407|FG004|Participant Flow|Admin Drug Day 0 and 28|Single administration day 0 and 28
11096485|NCT01564407|OG000|Outcome|no Injection|Empty control no injection
11096486|NCT01564407|OG001|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
11096487|NCT01564407|OG002|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
11096488|NCT01564407|OG003|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
11096489|NCT01564407|OG000|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
11096490|NCT01564407|OG003|Outcome|Single Admin Drug Day 28|Single administration on Day 28
11096491|NCT01564407|OG000|Outcome|no Injection|Safety cohort. 4 subjects received empty control. No injection
11096492|NCT01564407|OG000|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
11096493|NCT01564407|OG001|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
11096494|NCT01564407|OG002|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
11096495|NCT01564407|OG003|Outcome|No Injection|Empty safety control, no injection
11096496|NCT01564407|OG004|Outcome|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
11096497|NCT01564407|OG003|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
11096498|NCT01564407|OG004|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
11096499|NCT01564407|EG000|Reported Event|Vehicle Only,|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
11096500|NCT01564407|EG001|Reported Event|Single Admin Day 0|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
11096501|NCT01564407|EG002|Reported Event|Single Admin Day 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
11096502|NCT01564407|EG003|Reported Event|Admin Day 0 and 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
11096503|NCT01564407|EG004|Reported Event|no Injection|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
11096504|NCT01564459|BG000|Baseline|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
11096505|NCT01564459|BG001|Baseline|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
11096506|NCT01564459|BG002|Baseline|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
11096507|NCT01564459|BG003|Baseline|Total|Total of all reporting groups
11096508|NCT01564459|FG000|Participant Flow|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
11096509|NCT01564459|FG001|Participant Flow|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
11096510|NCT01564459|FG002|Participant Flow|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
11096511|NCT01564459|OG000|Outcome|MK-6096|Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
11096512|NCT01564459|OG001|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
11096513|NCT01564459|OG000|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
11096514|NCT01564459|OG000|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
11096515|NCT01564459|OG001|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
11096516|NCT01564459|OG002|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
11096517|NCT01564459|EG000|Reported Event|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
11096518|NCT01564459|EG001|Reported Event|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
11096519|NCT01564459|EG002|Reported Event|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
11096520|NCT01564485|BG000|Baseline|Cardiac CT Group|Asymptomatic patients with Type II DM who received cardiac CT screening test
11096521|NCT01564485|BG001|Baseline|Usual Care Group|Asymptomatic patients with Type II DM who received usual care
11096522|NCT01564485|BG002|Baseline|Total|Total of all reporting groups
11096523|NCT01564485|FG000|Participant Flow|Cardiac CT|"Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.~Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries."
11096524|NCT01564485|FG001|Participant Flow|Usual Care|"Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician~Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion."
11096525|NCT01564485|OG000|Outcome|Cardiac CT|"Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.~Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries."
11096526|NCT01564485|OG001|Outcome|Usual Care|"Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician~Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion."
11096527|NCT01564485|EG000|Reported Event|Cardiac CT|"Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.~Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries."
11096528|NCT01564485|EG001|Reported Event|Usual Care|"Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician~Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion."
11096529|NCT01564628|BG000|Baseline|All Study Participants|Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
11096530|NCT01564628|FG000|Participant Flow|Site 1A Population - CAD-score/CTA/CAG|Site 1A study population. Subject to CAD-score, CTA and, if relevant, CAG investigation.
11096531|NCT01564628|FG001|Participant Flow|Site 2 Population - CAD-score/CAG|Site 2 study population. Subject to CAD-score and CAG investigation
11096532|NCT01564628|FG002|Participant Flow|Site 1B Population - CAD-score/CTA/CAG|Site 1B study population. Subject to CAD-score, CTA and, if relevant, CAG investigation
11096533|NCT01564628|OG000|Outcome|All Study Participants|Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
11096534|NCT01564628|EG000|Reported Event|All Study Participants|Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
11096535|NCT01564654|BG000|Baseline|iTotal KRS|iTotal KRS: Total Knee Replacement System
11096536|NCT01564654|FG000|Participant Flow|iTotal KRS|iTotal KRS: Total Knee Replacement System
11096537|NCT01564654|OG000|Outcome|iTotal KRS|iTotal KRS: Total Knee Replacement System
11096538|NCT01564654|EG000|Reported Event|iTotal KRS|iTotal KRS: Total Knee Replacement System
11096539|NCT01564693|BG000|Baseline|ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as anorexic.
11096540|NCT01564693|BG001|Baseline|NON-ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as non-anorexic
11096541|NCT01564693|BG002|Baseline|CONTROL GROUP|These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
11096542|NCT01564693|BG003|Baseline|Total|Total of all reporting groups
11096543|NCT01564693|FG000|Participant Flow|ANOREXIC CANCER PATIENTS|We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.
11096544|NCT01564693|FG001|Participant Flow|NON-ANOREXIC CANCER PATIENTS|According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.
11096545|NCT01564693|FG002|Participant Flow|CONTROL GROUP|Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
11096546|NCT01564693|OG000|Outcome|ANOREXIC CANCER PATIENTS|Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
11096547|NCT01564693|OG001|Outcome|NON-ANOREXIC CANCER PATIENTS|Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
11096548|NCT01564693|OG002|Outcome|CONTROL GROUP|Healthy subjects were studied regarding BOLD signal activity by fMRI
11096549|NCT01564693|EG000|Reported Event|ANOREXIC CANCER PATIENTS|Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
11096550|NCT01564693|EG001|Reported Event|NON-ANOREXIC CANCER PATIENTS|Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
11096551|NCT01564693|EG002|Reported Event|CONTROL GROUP|Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
11096552|NCT01564706|BG000|Baseline|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
11096553|NCT01564706|FG000|Participant Flow|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
11096554|NCT01564706|OG000|Outcome|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
11096555|NCT01564706|EG000|Reported Event|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
11096556|NCT01564758|BG000|Baseline|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
11096557|NCT01564758|FG000|Participant Flow|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
11096558|NCT01564758|OG000|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
11096559|NCT01564758|EG000|Reported Event|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
11096560|NCT01564784|BG000|Baseline|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
11096561|NCT01564784|BG001|Baseline|Defined Investigator's Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
11096562|NCT01564784|BG002|Baseline|Total|Total of all reporting groups
11096563|NCT01564784|FG000|Participant Flow|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
11096564|NCT01564784|FG001|Participant Flow|Defined Investigator's Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
11096565|NCT01564784|OG000|Outcome|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
11096566|NCT01564784|OG001|Outcome|Defined Investigator's Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
11328384|NCT03426995|OG001|Outcome|Part C: Cohort 6- GSK3358699 RD|Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 on Days 1 to 14.
11328385|NCT03426995|OG002|Outcome|Part C: Cohort 7- GSK3358699 RD|Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 on Days 1 to 14.
11218030|NCT02318602|OG000|Outcome|Infants|"Participants 1 to <2 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
10834118|NCT00159822|EG000|Reported Event|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator's clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
10834119|NCT00159861|BG000|Baseline|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834120|NCT00159861|BG001|Baseline|Sildenafil/Sildenafil|Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
11096567|NCT01564784|EG000|Reported Event|Inotuzumab Ozogamicin|Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
11096568|NCT01564784|EG001|Reported Event|Defined Investigator's Choice of Chemotherapy|Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
10834121|NCT00159861|BG002|Baseline|Total|Total of all reporting groups
10834122|NCT00159861|FG000|Participant Flow|Placebo: Core Study / Sildenafil: Extension Study|Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834123|NCT00159861|FG001|Participant Flow|Sildenafil: Core Study / Sildenafil: Extension Study|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834124|NCT00159861|OG000|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834125|NCT00159861|OG000|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator.
10834126|NCT00159861|OG000|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834127|NCT00159861|OG001|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834128|NCT00159861|OG000|Outcome|Placebo/Sildenafil|Core Study A1481141: Placebo TID (3 times daily); Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834129|NCT00159861|OG001|Outcome|Sldenafil/Sildenafil|Core Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834130|NCT00159861|EG000|Reported Event|Placebo/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834131|NCT00159861|EG001|Reported Event|Sildenafil/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
10834132|NCT00159861|EG002|Reported Event|Placebo/Discontinued|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued
10834133|NCT00159874|BG000|Baseline|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834134|NCT00159874|BG001|Baseline|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834135|NCT00159874|BG002|Baseline|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834136|NCT00159874|BG003|Baseline|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
10834137|NCT00159874|BG004|Baseline|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
10834138|NCT00159874|BG005|Baseline|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
11096569|NCT01564862|BG000|Baseline|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
11096570|NCT01564862|BG001|Baseline|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
11096571|NCT01564862|BG002|Baseline|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
11096572|NCT01564862|BG003|Baseline|Total|Total of all reporting groups
11096573|NCT01564862|FG000|Participant Flow|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
11096574|NCT01564862|FG001|Participant Flow|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
11096575|NCT01564862|FG002|Participant Flow|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
11096576|NCT01564862|OG000|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
11096577|NCT01564862|OG001|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
11096578|NCT01564862|OG002|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
11096579|NCT01564862|EG000|Reported Event|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
11096580|NCT01564862|EG001|Reported Event|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
11096581|NCT01564862|EG002|Reported Event|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
11096582|NCT01564914|BG000|Baseline|TRC105, Bevacizumab|"Single arm study~TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV 10 mg/kg every 2 weeks"
11096583|NCT01564914|BG001|Baseline|TRC105|"Single arm~TRC105: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle"
11096584|NCT01564914|BG002|Baseline|Total|Total of all reporting groups
11096585|NCT01564914|FG000|Participant Flow|Carotuximab (TRC105), Bevacizumab|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV 10 mg/kg every 2 weeks"
11096586|NCT01564914|FG001|Participant Flow|Carotuximab (TRC105)|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle"
11328386|NCT03426995|OG003|Outcome|Part C: Cohort 8- GSK3358699 RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
11096587|NCT01564914|OG000|Outcome|Carotuximab (TRC105), Bevacizumab|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV 10 mg/kg every 2 weeks"
11096588|NCT01564914|OG000|Outcome|Carotuximab (TRC105), Bevacizumab|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV"
11096589|NCT01564914|OG001|Outcome|Carotuximab (TRC105)|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle"
11096590|NCT01564914|OG000|Outcome|Carotuximab (TRC105), Bevacizumab|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV 10 mg/kg every two weeks"
11096591|NCT01564914|OG001|Outcome|Carotuximab (TRC105) Alone|TRC105 alone 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
11096592|NCT01564914|EG000|Reported Event|Carotuximab (TRC105), Bevacizumab|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle~Bevacizumab: IV 10 mg/kg every 2 weeks"
11096593|NCT01564914|EG001|Reported Event|Carotuximab (TRC105)|"Single arm study~Carotuximab (TRC105): 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle"
11096594|NCT01564953|BG000|Baseline|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
11096595|NCT01564953|FG000|Participant Flow|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
11096596|NCT01564953|OG000|Outcome|Serum Vitamin D|Participants' serum vitamin D
11096597|NCT01564953|OG000|Outcome|Lung Function|lung function measured as forced expiratory volumes in 1 second.
11096598|NCT01564953|OG000|Outcome|Serum Magnesium|Serum magnesium in plasma, in mmol/L
11096599|NCT01564953|OG000|Outcome|Serum Calcium|Serum ionized calcium, in mmol/L
11096600|NCT01564953|OG000|Outcome|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test
11096601|NCT01564953|EG000|Reported Event||Adverse Events were not collected for the 143 participants
11328387|NCT03426995|OG003|Outcome|Part C: Cohort 8- GSK3358699 RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
11328388|NCT03426995|OG000|Outcome|Part C: Cohort 4 and 5- Placebo RD|Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM CSF was followed by blister induction on forearm (0.2% cantharidin).
11328389|NCT03426995|OG001|Outcome|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM CSF was followed by blister induction on forearm (0.2% cantharidin).
10834139|NCT00159874|BG006|Baseline|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
10834140|NCT00159874|BG007|Baseline|Total|Total of all reporting groups
10834141|NCT00159874|FG000|Participant Flow|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834142|NCT00159874|FG001|Participant Flow|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834143|NCT00159874|FG002|Participant Flow|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834144|NCT00159874|FG003|Participant Flow|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
10834145|NCT00159874|FG004|Participant Flow|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
10834146|NCT00159874|FG005|Participant Flow|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
10834147|NCT00159874|FG006|Participant Flow|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
10834148|NCT00159874|OG000|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834149|NCT00159874|OG001|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834150|NCT00159874|OG002|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
10834151|NCT00159874|OG003|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
10834152|NCT00159874|OG004|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
10834153|NCT00159874|OG005|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
10834154|NCT00159874|OG006|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
10834155|NCT00159874|OG000|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
10834156|NCT00159874|OG001|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
10834157|NCT00159874|OG002|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
10834158|NCT00159874|OG000|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
10834159|NCT00159874|EG000|Reported Event|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
10834160|NCT00159874|EG001|Reported Event|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
10834161|NCT00159874|EG002|Reported Event|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
10834162|NCT00159913|BG000|Baseline|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
11096602|NCT01565083|BG000|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096603|NCT01565083|BG001|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096604|NCT01565083|BG002|Baseline|Total|Total of all reporting groups
11096605|NCT01565083|FG000|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096606|NCT01565083|FG001|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096607|NCT01565083|OG000|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096608|NCT01565083|OG001|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096609|NCT01565083|EG000|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096610|NCT01565083|EG001|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
11096611|NCT01565148|BG000|Baseline|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
11096612|NCT01565148|BG001|Baseline|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
11096613|NCT01565148|BG002|Baseline|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
11096614|NCT01565148|BG003|Baseline|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
11096615|NCT01565148|BG004|Baseline|Total|Total of all reporting groups
11096616|NCT01565148|FG000|Participant Flow|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
11096617|NCT01565148|FG001|Participant Flow|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
11096618|NCT01565148|FG002|Participant Flow|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
11096619|NCT01565148|FG003|Participant Flow|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
11096620|NCT01565148|OG000|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
11096621|NCT01565148|OG001|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
11096622|NCT01565148|OG002|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
11096623|NCT01565148|OG003|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
11096624|NCT01565148|OG000|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
11096625|NCT01565148|OG001|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
11096626|NCT01565148|OG002|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
11096627|NCT01565148|OG003|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
11096628|NCT01565148|EG000|Reported Event|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
11096629|NCT01565148|EG001|Reported Event|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
11096630|NCT01565148|EG002|Reported Event|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
11096631|NCT01565148|EG003|Reported Event|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
11096632|NCT01565291|BG000|Baseline|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
11096633|NCT01565291|BG001|Baseline|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
11096634|NCT01565291|BG002|Baseline|Total|Total of all reporting groups
11096635|NCT01565291|FG000|Participant Flow|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
11096636|NCT01565291|FG001|Participant Flow|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
11096637|NCT01565291|OG000|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
11096638|NCT01565291|OG001|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
11096639|NCT01565291|EG000|Reported Event|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
11096640|NCT01565291|EG001|Reported Event|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
11096641|NCT01565330|BG000|Baseline|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
11096642|NCT01565330|BG001|Baseline|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
11096643|NCT01565330|BG002|Baseline|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
11096644|NCT01565330|BG003|Baseline|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
11096645|NCT01565330|BG004|Baseline|Total|Total of all reporting groups
11096646|NCT01565330|FG000|Participant Flow|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
11096647|NCT01565330|FG001|Participant Flow|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
11096648|NCT01565330|FG002|Participant Flow|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
11096649|NCT01565330|FG003|Participant Flow|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
11096650|NCT01565330|OG000|Outcome|111 MBq (3 mCi) AD Group|Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
11096651|NCT01565330|OG001|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
11096652|NCT01565330|OG002|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
11096653|NCT01565330|OG003|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
11096654|NCT01565330|OG000|Outcome|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
11096655|NCT01565330|EG000|Reported Event|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
11096656|NCT01565330|EG001|Reported Event|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
11096657|NCT01565330|EG002|Reported Event|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
11096658|NCT01565330|EG003|Reported Event|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
11096659|NCT01565343|BG000|Baseline|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
11096660|NCT01565343|BG001|Baseline|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
11096661|NCT01565343|BG002|Baseline|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
11096662|NCT01565343|BG003|Baseline|Total|Total of all reporting groups
11096663|NCT01565343|FG000|Participant Flow|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
11096664|NCT01565343|FG001|Participant Flow|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
11096665|NCT01565343|FG002|Participant Flow|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
11096666|NCT01565343|OG000|Outcome|AD Subjects|Male or female subjects > 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
11096667|NCT01565343|OG001|Outcome|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
11096668|NCT01565343|EG000|Reported Event|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
11096669|NCT01565343|EG001|Reported Event|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
11096670|NCT01565343|EG002|Reported Event|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
11096671|NCT01565356|BG000|Baseline|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
11096672|NCT01565356|FG000|Participant Flow|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
11096673|NCT01565356|OG000|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
11096674|NCT01565356|EG000|Reported Event|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
11096675|NCT01565369|BG000|Baseline|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
11096676|NCT01565369|FG000|Participant Flow|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
11096677|NCT01565369|OG000|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
11096678|NCT01565369|OG000|Outcome|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
11096679|NCT01565369|EG000|Reported Event|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
11096680|NCT01565382|BG000|Baseline|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
11096681|NCT01565382|FG000|Participant Flow|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
11096682|NCT01565382|FG001|Participant Flow|Physicians|Private nuclear medicine physicians with no previous training in reading florbetapir scans.
11096683|NCT01565382|OG000|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
11096684|NCT01565382|OG000|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
11096685|NCT01565382|EG000|Reported Event|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
11096686|NCT01565499|BG000|Baseline|Nab-Paclitaxel|"The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.~Nab-paclitaxel"
11096687|NCT01565499|FG000|Participant Flow|Nab-Paclitaxel|"The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.~Nab-paclitaxel"
11096688|NCT01565499|OG000|Outcome|Nab-Paclitaxel|"The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.~Nab-paclitaxel"
11096689|NCT01565499|EG000|Reported Event|Nab-Paclitaxel|"The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.~Nab-paclitaxel"
11096690|NCT01565538|BG000|Baseline|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
11096691|NCT01565538|BG001|Baseline|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
11096692|NCT01565538|BG002|Baseline|Total|Total of all reporting groups
11096693|NCT01565538|FG000|Participant Flow|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
11096694|NCT01565538|FG001|Participant Flow|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
11096695|NCT01565538|OG000|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
11096696|NCT01565538|OG001|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
11096697|NCT01565538|EG000|Reported Event|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
11096698|NCT01565538|EG001|Reported Event|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
11328390|NCT03426995|OG004|Outcome|Part C: Cohort 8- GSK3358699 or Placebo RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
11096699|NCT01565551|BG000|Baseline|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
11096700|NCT01565551|BG001|Baseline|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
11096701|NCT01565551|BG002|Baseline|Total|Total of all reporting groups
11096702|NCT01565551|FG000|Participant Flow|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
11096703|NCT01565551|FG001|Participant Flow|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
11096704|NCT01565551|OG000|Outcome|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
11096705|NCT01565551|OG001|Outcome|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
11096706|NCT01565551|EG000|Reported Event|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
11096707|NCT01565551|EG001|Reported Event|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
11096708|NCT01565564|BG000|Baseline|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096709|NCT01565564|BG001|Baseline|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096710|NCT01565564|BG002|Baseline|Total|Total of all reporting groups
11096711|NCT01565564|FG000|Participant Flow|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096712|NCT01565564|FG001|Participant Flow|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096713|NCT01565564|OG000|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096714|NCT01565564|OG001|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096715|NCT01565564|EG000|Reported Event|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096716|NCT01565564|EG001|Reported Event|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
11096717|NCT01565616|BG000|Baseline|Bone Marrow Transplant Recipients|Individuals receiving a bone marrow transplant at one of 10 study locations, between March 2012 and June, 2015.
11096718|NCT01565616|FG000|Participant Flow|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
11096719|NCT01565616|OG000|Outcome|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
11096720|NCT01565616|EG000|Reported Event|Bone Marrow Transplant Recipients|Individuals with severe sickle cell disease receiving hematopoietic cell transplantation (HCT) from a human leukocyte antigen (HLA)-identical sibling donor or an unrelated HLA-matched donor
11096721|NCT01565642|BG000|Baseline|Decision Support Intervention|"Decision aid and care plan meeting~Goals of care decision support: Decision aid and care plan meeting"
11096722|NCT01565642|BG001|Baseline|Control|Attention control information on dementia care
11096723|NCT01565642|BG002|Baseline|Total|Total of all reporting groups
11096724|NCT01565642|FG000|Participant Flow|Decision Support Intervention|"Decision aid and care plan meeting~Goals of care decision support: Decision aid and care plan meeting"
11096725|NCT01565642|FG001|Participant Flow|Control|Attention control information on dementia care
11096726|NCT01565642|OG000|Outcome|Decision Support Intervention|"Decision aid and care plan meeting~Goals of care decision support: Decision aid and care plan meeting"
11096727|NCT01565642|OG001|Outcome|Control|Attention control information on dementia care
11096728|NCT01565642|EG000|Reported Event|Decision Support Intervention|"Decision aid and care plan meeting~Goals of care decision support: Decision aid and care plan meeting"
11096729|NCT01565642|EG001|Reported Event|Control|Attention control information on dementia care
11096730|NCT01565668|BG000|Baseline|Quizartinib 30 mg|Participants randomized to receive 30 mg quizartinib once daily.
11096731|NCT01565668|BG001|Baseline|Quizartinib 60 mg|Participants were randomized to receive 60 mg quizartinib once daily.
11096732|NCT01565668|BG002|Baseline|Total|Total of all reporting groups
11096733|NCT01565668|FG000|Participant Flow|Quizartinib 30 mg|Participants randomized to receive 30 mg quizartinib once daily.
11096734|NCT01565668|FG001|Participant Flow|Quizartinib 60 mg|Participants randomized to receive 60 mg quizartinib once daily.
11096735|NCT01565668|OG000|Outcome|Quizartinib 30 mg|Participants randomized to receive 30 mg quizartinib once daily.
11096736|NCT01565668|OG001|Outcome|Quizartinib 60 mg|Participants randomized to receive 60 mg quizartinib once daily.
11096737|NCT01565668|EG000|Reported Event|Quizartinib 30 mg|Participants randomized to receive 30 mg quizartinib once daily.
11096738|NCT01565668|EG001|Reported Event|Quizartinib 60 mg|Participants randomized to receive 60 mg quizartinib once daily.
11096739|NCT01565694|BG000|Baseline|Solifenacin Succinate|Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify optimal dose during the dose-titration period. After the dose titration period participants entered the fixed-dose period and received a fixed dose of solifenacin once a day orally for 40 weeks or until the end of study visit (Week 52).
11096740|NCT01565694|FG000|Participant Flow|Solifenacin Succinate|Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during dose-titration period. After completing dose titration period, participants entered fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
11096741|NCT01565694|OG000|Outcome|Solifenacin Succinate|Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
11096742|NCT01565694|EG000|Reported Event|Solifenacin Succinate|Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
11096743|NCT01565707|BG000|Baseline|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
11096744|NCT01565707|BG001|Baseline|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096745|NCT01565707|BG002|Baseline|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
11096746|NCT01565707|BG003|Baseline|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096747|NCT01565707|BG004|Baseline|Total|Total of all reporting groups
11096748|NCT01565707|FG000|Participant Flow|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
11096749|NCT01565707|FG001|Participant Flow|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096750|NCT01565707|FG002|Participant Flow|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
11096751|NCT01565707|FG003|Participant Flow|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096752|NCT01565707|OG000|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
11096753|NCT01565707|OG001|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096754|NCT01565707|OG002|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
11096755|NCT01565707|OG003|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096756|NCT01565707|OG000|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
11096757|NCT01565707|OG001|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
11096758|NCT01565707|OG000|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
11096759|NCT01565707|OG001|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
11096760|NCT01565707|OG002|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
11096761|NCT01565707|OG003|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
11096762|NCT01565707|OG004|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
11096763|NCT01565707|EG000|Reported Event|Placebo Children|Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.
11096764|NCT01565707|EG001|Reported Event|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.
11096765|NCT01565707|EG002|Reported Event|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.
11096766|NCT01565707|EG003|Reported Event|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
11096767|NCT01565850|BG000|Baseline|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
11096768|NCT01565850|BG001|Baseline|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
11096769|NCT01565850|BG002|Baseline|Total|Total of all reporting groups
11096770|NCT01565850|FG000|Participant Flow|D/C/F/TAF|Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
11096771|NCT01565850|FG001|Participant Flow|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
11096772|NCT01565850|OG000|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
11096773|NCT01565850|OG001|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
11096774|NCT01565850|EG000|Reported Event|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
11096775|NCT01565850|EG001|Reported Event|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
11096776|NCT01565889|BG000|Baseline|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
11096777|NCT01565889|BG001|Baseline|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
11096778|NCT01565889|BG002|Baseline|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096779|NCT01565889|BG003|Baseline|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
10834163|NCT00159913|BG001|Baseline|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834164|NCT00159913|BG002|Baseline|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834165|NCT00159913|BG003|Baseline|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
10834166|NCT00159913|BG004|Baseline|Total|Total of all reporting groups
10834167|NCT00159913|FG000|Participant Flow|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
10834168|NCT00159913|FG001|Participant Flow|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834169|NCT00159913|FG002|Participant Flow|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834170|NCT00159913|FG003|Participant Flow|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
10834171|NCT00159913|OG000|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
10834172|NCT00159913|OG001|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834173|NCT00159913|OG002|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834174|NCT00159913|OG003|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
10834175|NCT00159913|OG004|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
10834176|NCT00159913|EG000|Reported Event|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
10834177|NCT00159913|EG001|Reported Event|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834178|NCT00159913|EG002|Reported Event|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
10834179|NCT00159913|EG003|Reported Event|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
10834180|NCT00159913|EG004|Reported Event|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
10834181|NCT00159965|BG000|Baseline|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834182|NCT00159965|BG001|Baseline|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834183|NCT00159965|BG002|Baseline|Total|Total of all reporting groups
10834184|NCT00159965|FG000|Participant Flow|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834185|NCT00159965|FG001|Participant Flow|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834186|NCT00159965|OG000|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834187|NCT00159965|OG001|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834188|NCT00159965|EG000|Reported Event|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834189|NCT00159965|EG001|Reported Event|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
10834190|NCT00160199|BG000|Baseline|Prometrium 300 mg/Day|
10834191|NCT00160199|BG001|Baseline|Prometrium 400 mg/Day|
10834192|NCT00160199|BG002|Baseline|Total|Total of all reporting groups
10834193|NCT00160199|FG000|Participant Flow|Prometrium 300 mg/Day|
10834194|NCT00160199|FG001|Participant Flow|Prometrium 400 mg/Day|
10834195|NCT00160199|OG000|Outcome|Prometrium 300 mg/Day|
10834196|NCT00160199|OG001|Outcome|Prometrium 400 mg/Day|
10834197|NCT00160199|EG000|Reported Event|Prometrium 300 mg/Day|
10834198|NCT00160199|EG001|Reported Event|Prometrium 400 mg/Day|
10834199|NCT00160251|BG000|Baseline|Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
10834200|NCT00160251|BG001|Baseline|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834201|NCT00160251|BG002|Baseline|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834202|NCT00160251|BG003|Baseline|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834203|NCT00160251|BG004|Baseline|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834204|NCT00160251|BG005|Baseline|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834205|NCT00160251|BG006|Baseline|Total|Total of all reporting groups
10834206|NCT00160251|FG000|Participant Flow|Arm 1A: PEG + RBV|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834207|NCT00160251|FG001|Participant Flow|Arm 1B: PEG + RBV + BOC|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834208|NCT00160251|FG002|Participant Flow|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834209|NCT00160251|FG003|Participant Flow|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834210|NCT00160251|FG004|Participant Flow|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834211|NCT00160251|FG005|Participant Flow|ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834212|NCT00160251|FG006|Participant Flow|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834213|NCT00160251|FG007|Participant Flow|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
10834214|NCT00160251|OG000|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834215|NCT00160251|OG001|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834216|NCT00160251|OG002|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834217|NCT00160251|OG003|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834218|NCT00160251|OG004|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834219|NCT00160251|OG005|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834220|NCT00160251|OG000|Outcome|0 to ≤ 4 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
10834221|NCT00160251|OG001|Outcome|>4 to 8 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 4 to 8.
10834222|NCT00160251|OG002|Outcome|>8 to 12 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 8 to 12.
10834223|NCT00160251|OG003|Outcome|>12 to 36 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 12 to 36.
10834224|NCT00160251|OG000|Outcome|Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400|A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834225|NCT00160251|OG001|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834226|NCT00160251|OG002|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834227|NCT00160251|OG000|Outcome|Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
11096780|NCT01565889|BG004|Baseline|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
11096781|NCT01565889|BG005|Baseline|Part B: SOF+PEG+RBV|"SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.~This reporting group presents data for those participants who joined the study for Part B only."
11096782|NCT01565889|BG006|Baseline|Total|Total of all reporting groups
11096783|NCT01565889|FG000|Participant Flow|Part A: SOF+EFV/FTC/TDF (Cohort 1)|Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
11096784|NCT01565889|FG001|Participant Flow|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
11096785|NCT01565889|FG002|Participant Flow|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096786|NCT01565889|FG003|Participant Flow|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096787|NCT01565889|FG004|Participant Flow|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
11096788|NCT01565889|FG005|Participant Flow|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11096789|NCT01565889|OG000|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
11096790|NCT01565889|OG001|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
11096791|NCT01565889|OG002|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096792|NCT01565889|OG003|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096793|NCT01565889|OG004|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
11096794|NCT01565889|OG000|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11096795|NCT01565889|OG005|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11096796|NCT01565889|EG000|Reported Event|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
11096797|NCT01565889|EG001|Reported Event|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
11096798|NCT01565889|EG002|Reported Event|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096799|NCT01565889|EG003|Reported Event|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
11096800|NCT01565889|EG004|Reported Event|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
11096801|NCT01565889|EG005|Reported Event|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
11096802|NCT01565902|BG000|Baseline|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096803|NCT01565902|BG001|Baseline|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096804|NCT01565902|BG002|Baseline|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096805|NCT01565902|BG003|Baseline|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
11096806|NCT01565902|BG004|Baseline|Total|Total of all reporting groups
11096807|NCT01565902|FG000|Participant Flow|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096808|NCT01565902|FG001|Participant Flow|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096809|NCT01565902|FG002|Participant Flow|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096810|NCT01565902|FG003|Participant Flow|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
11096811|NCT01565902|OG000|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096812|NCT01565902|OG001|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096813|NCT01565902|OG002|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096814|NCT01565902|OG003|Outcome|Matched Healthy Subjects - Mild|Treatment with a single oral dose of 0.25 mg BAF312
11096815|NCT01565902|OG004|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
11096816|NCT01565902|OG005|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
11096817|NCT01565902|OG003|Outcome|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
11096818|NCT01565902|EG000|Reported Event|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096819|NCT01565902|EG001|Reported Event|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096820|NCT01565902|EG002|Reported Event|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
11096821|NCT01565902|EG003|Reported Event|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
11096822|NCT01565928|BG000|Baseline|Docetaxel 75 mg/m^2+ Enzalutamide 160 mg|Docetaxel 75 milligrams per square meter (mg/m^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
11096823|NCT01565928|FG000|Participant Flow|Docetaxel 75 mg/m^2+ Enzalutamide 160 mg|Docetaxel 75 milligrams per square meter (mg/m^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
11096824|NCT01565928|OG000|Outcome|Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg|Docetaxel 75 mg/m^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.
11096825|NCT01565928|OG000|Outcome|Docetaxel 75 mg/m^2+ Enzalutamide 160 mg|Docetaxel 75 milligrams per square meter (mg/m^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
11096826|NCT01565928|OG001|Outcome|Post-Docetaxel Enzalutamide 160 mg|Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
11096827|NCT01565928|EG000|Reported Event|Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg|Docetaxel 75 mg/m^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.
11096828|NCT01565928|EG001|Reported Event|Post-Docetaxel Enzalutamide 160 mg|Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
11096829|NCT01565941|BG000|Baseline|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
11096830|NCT01565941|BG001|Baseline|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
11096831|NCT01565941|BG002|Baseline|Total|Total of all reporting groups
11096832|NCT01565941|FG000|Participant Flow|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
11096833|NCT01565941|FG001|Participant Flow|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
11096834|NCT01565941|OG000|Outcome|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
11096835|NCT01565941|OG001|Outcome|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
11096836|NCT01565941|OG000|Outcome|Perceived Nursing Workload: Caring for TGC Group 1 Patients|Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm. The nurses surveyed were caring for a patient in this treatment arm.
11096837|NCT01565941|OG001|Outcome|Perceived Nursing Workload: Caring for TGC Group 2 Patients|Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm. The nurses surveyed were caring for a patient in this treatment arm.
11096838|NCT01565941|EG000|Reported Event|Tight Glycemic Control 1 (TGC-1)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL"
11096839|NCT01565941|EG001|Reported Event|Tight Glycemic Control 2 (TGC-2)|"Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL"
11096840|NCT01565980|BG000|Baseline|Attention Control|weekly symptom assessment phone calls.
11096841|NCT01565980|BG001|Baseline|Mindfulness Intervention|"Participants receive weekly symptom assessment phone calls.~Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention."
11096842|NCT01565980|BG002|Baseline|Total|Total of all reporting groups
11096843|NCT01565980|FG000|Participant Flow|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
11096844|NCT01565980|FG001|Participant Flow|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
11096845|NCT01565980|OG000|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
11096846|NCT01565980|OG001|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
11096847|NCT01565980|OG000|Outcome|Symptom Assessment|"6 weeks of symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks."
11096848|NCT01565980|OG001|Outcome|Mindfulness Intervention|"Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks."
11096849|NCT01565980|OG000|Outcome|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
11096850|NCT01565980|OG001|Outcome|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
11096851|NCT01565980|EG000|Reported Event|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
11096852|NCT01565980|EG001|Reported Event|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention."
11096853|NCT01565993|BG000|Baseline|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
11096854|NCT01565993|BG001|Baseline|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
11096855|NCT01565993|BG002|Baseline|Total|Total of all reporting groups
11096856|NCT01565993|FG000|Participant Flow|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
11096857|NCT01565993|FG001|Participant Flow|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
11096858|NCT01565993|OG000|Outcome|Hemoclip|"In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
11096859|NCT01565993|OG001|Outcome|Conventional Polipectomy|In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.
11096860|NCT01565993|EG000|Reported Event|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
11096861|NCT01565993|EG001|Reported Event|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
11096862|NCT01566084|BG000|Baseline|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.~Subjects then cross-over to the placebo arm in the second half of the study."
11096863|NCT01566084|BG001|Baseline|Placebo (Start)|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the slow sodium tablet arm in the second half of the study."
11096864|NCT01566084|BG002|Baseline|Total|Total of all reporting groups
11096865|NCT01566084|FG000|Participant Flow|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~Subjects then cross over to the opposite condition in the second half of the study."
11096866|NCT01566084|FG001|Participant Flow|Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the opposite condition in the second half of the study."
11096867|NCT01566084|OG000|Outcome|Normal Sodium Diet|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.
11096868|NCT01566084|OG001|Outcome|Low Sodium Diet.|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
11096869|NCT01566084|OG000|Outcome|Normal Sodium Saline|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
11096870|NCT01566084|OG001|Outcome|Low Sodium Saline|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
11096871|NCT01566084|OG002|Outcome|Normal Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
11096872|NCT01566084|OG003|Outcome|Low Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
11096873|NCT01566084|OG000|Outcome|Normal Sodium Placebo|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
11096874|NCT01566084|OG001|Outcome|Low Sodium Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
11096875|NCT01566084|OG002|Outcome|Normal Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
11096876|NCT01566084|OG003|Outcome|Low Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
11096877|NCT01566084|EG000|Reported Event|Normal Sodium|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
11096878|NCT01566084|EG001|Reported Event|Low Sodium|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
11096879|NCT01566162|BG000|Baseline|Lurasidone|"Lurasidone 40 - 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
11096880|NCT01566162|FG000|Participant Flow|Lurasidone|"Lurasidone 40 - 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
11096881|NCT01566162|OG000|Outcome|Lurasidone|"Lurasidone 40 - 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
11096882|NCT01566162|EG000|Reported Event|Lurasidone|"Lurasidone 40 - 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
11096883|NCT01566214|BG000|Baseline|Motivational Interview|For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
11096884|NCT01566214|BG001|Baseline|Usual Care|For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
11096885|NCT01566214|BG002|Baseline|Total|Total of all reporting groups
11096886|NCT01566214|FG000|Participant Flow|Motivational Interview|For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
11096887|NCT01566214|FG001|Participant Flow|Usual Care|For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
11096888|NCT01566214|OG000|Outcome|Motivational Interview|For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
11096889|NCT01566214|OG001|Outcome|Usual Care|For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
11096890|NCT01566214|EG000|Reported Event|Motivational Interview|For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
11096891|NCT01566214|EG001|Reported Event|Usual Care|For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
11096892|NCT01566331|BG000|Baseline|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
11096893|NCT01566331|BG001|Baseline|Baby-guardTM With Minimal Inflation|Baby-guardTM system, with minimal inflation in women who expected natural delivery
11096894|NCT01566331|BG002|Baseline|Total|Total of all reporting groups
11096895|NCT01566331|FG000|Participant Flow|Baby-guardTM|"Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes~Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes"
11096896|NCT01566331|FG001|Participant Flow|Baby-guardTM Minimal Inflation|Baby-guardTM with minimal inflation who expected natural delivery
11096897|NCT01566331|OG000|Outcome|Baby Belt Device Group|
11096898|NCT01566331|OG001|Outcome|Baby-guardTM With Minimal Inflation|
11096899|NCT01566331|EG000|Reported Event|Baby Birth|group delivering with baby birth
11096900|NCT01566331|EG001|Reported Event|Baby Birth With Minimal Inflation|group delivering with dwvice and minimal inflation
11096901|NCT01566409|BG000|Baseline|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
11096902|NCT01566409|BG001|Baseline|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
11096903|NCT01566409|BG002|Baseline|Total|Total of all reporting groups
11096904|NCT01566409|FG000|Participant Flow|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
11096905|NCT01566409|FG001|Participant Flow|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
11096906|NCT01566409|OG000|Outcome|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
11096907|NCT01566409|OG001|Outcome|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
11096908|NCT01566409|EG000|Reported Event|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
11096909|NCT01566409|EG001|Reported Event|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
11096910|NCT01566435|BG000|Baseline|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
11096911|NCT01566435|FG000|Participant Flow|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
11096912|NCT01566435|OG000|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
11096913|NCT01566435|OG000|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
11096914|NCT01566435|OG000|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
11096915|NCT01566435|EG000|Reported Event|ACF Induction Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF."
11096916|NCT01566435|EG001|Reported Event|ACF Definitive Chemoradiation Therapy-cisplatin|"Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
11096917|NCT01566435|EG002|Reported Event|ACF Definitive Chemoradiation Therapy-cetuximab|"Definitive Therapy~Cetuximab 250 mg/m^2 IV weekly for 8 weeks~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
11096918|NCT01566448|BG000|Baseline|Ketamine|"Ketamine oral mouthwash 20mg/5ml swish and spit four times daily~Ketamine: 20mg/5ml swish and spit four times daily"
11096919|NCT01566448|FG000|Participant Flow|Ketamine|"Ketamine oral mouthwash 20mg/5ml swish and spit four times daily~Ketamine: 20mg/5ml swish and spit four times daily"
11096920|NCT01566448|OG000|Outcome|Ketamine|"Ketamine oral mouthwash 20mg/5ml swish and spit four times daily~Ketamine: 20mg/5ml swish and spit four times daily"
11096921|NCT01566448|EG000|Reported Event|Ketamine|"Ketamine oral mouthwash 20mg/5ml swish and spit four times daily~Ketamine: 20mg/5ml swish and spit four times daily"
11096922|NCT01566461|BG000|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096923|NCT01566461|BG001|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096924|NCT01566461|BG002|Baseline|Total|Total of all reporting groups
11096925|NCT01566461|FG000|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096926|NCT01566461|FG001|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096927|NCT01566461|OG000|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
11096928|NCT01566461|OG001|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
11096929|NCT01566461|EG000|Reported Event|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096930|NCT01566461|EG001|Reported Event|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
11096931|NCT01566500|BG000|Baseline|Study Sample|Adults with self-reported epilepsy.
11096932|NCT01566500|FG000|Participant Flow|Study Sample|Adults with self-reported epilepsy.
11096933|NCT01566500|OG000|Outcome|Study Sample|Adults with self-reported epilepsy.
11096934|NCT01566500|EG000|Reported Event|Study Sample|Adults with self-reported epilepsy.
11096935|NCT01566526|BG000|Baseline|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
11096936|NCT01566526|FG000|Participant Flow|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
11096937|NCT01566526|OG000|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
11096938|NCT01566526|EG000|Reported Event|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
11096939|NCT01566539|BG000|Baseline|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
11096940|NCT01566539|BG001|Baseline|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
11096941|NCT01566539|BG002|Baseline|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096942|NCT01566539|BG003|Baseline|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
11096943|NCT01566539|BG004|Baseline|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096944|NCT01566539|BG005|Baseline|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096945|NCT01566539|BG006|Baseline|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096946|NCT01566539|BG007|Baseline|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
11096947|NCT01566539|BG008|Baseline|Total|Total of all reporting groups
11096948|NCT01566539|FG000|Participant Flow|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
11096949|NCT01566539|FG001|Participant Flow|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
11096950|NCT01566539|FG002|Participant Flow|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096951|NCT01566539|FG003|Participant Flow|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
11096952|NCT01566539|FG004|Participant Flow|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
11096953|NCT01566539|FG005|Participant Flow|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096954|NCT01566539|FG006|Participant Flow|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096955|NCT01566539|FG007|Participant Flow|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096956|NCT01566539|FG008|Participant Flow|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
11096957|NCT01566539|OG000|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
11096958|NCT01566539|OG001|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096959|NCT01566539|OG000|Outcome|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
11096960|NCT01566539|OG000|Outcome|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
11096961|NCT01566539|OG001|Outcome|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
11096962|NCT01566539|OG002|Outcome|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096963|NCT01566539|OG000|Outcome|Within Subject Group|Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.
11096964|NCT01566539|OG000|Outcome|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
11096965|NCT01566539|OG001|Outcome|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096966|NCT01566539|OG000|Outcome|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096967|NCT01566539|OG001|Outcome|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096968|NCT01566539|EG000|Reported Event|Healthy Volunteers - Intranasal Vasopressin (AVP)|"The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total)."
11096969|NCT01566539|EG001|Reported Event|Healthy Volunteers - Intranasal Oxytocin (OT)|"The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total."
11096970|NCT01566539|EG002|Reported Event|Healthy Volunteers - Intranasal Placebo|"The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096971|NCT01566539|EG003|Reported Event|Within Subject Group|"Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).~Intranasal Placebo: Participants will receive placebo sprays that are pH"
11096972|NCT01566539|EG004|Reported Event|Faces Task - Vasopressin (AVP)|"Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.~Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP."
11096973|NCT01566539|EG005|Reported Event|Faces Task - Placebo|"Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11328391|NCT03426995|EG000|Reported Event|Part A: Placebo SD|Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
11328392|NCT03426995|EG001|Reported Event|Part A: GSK3358699 1 mg SD|Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
11328393|NCT03426995|EG002|Reported Event|Part A: GSK3358699 3 mg SD|Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
11328394|NCT03426995|EG003|Reported Event|Part A: GSK3358699 10 mg SD|Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
11328395|NCT03426995|EG004|Reported Event|Part A: GSK3358699 20 mg SD|Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
11096974|NCT01566539|EG006|Reported Event|Empathy Task - Oxytocin (OT)|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.~Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096975|NCT01566539|EG007|Reported Event|Empathy Task - Placebo|"Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.~Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total."
11096976|NCT01566539|EG008|Reported Event|Healthy Volunteers - Lorazepam|"Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.~Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan."
11096977|NCT01566604|BG000|Baseline|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
11096978|NCT01566604|BG001|Baseline|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
11096979|NCT01566604|BG002|Baseline|Total|Total of all reporting groups
11096980|NCT01566604|FG000|Participant Flow|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
11096981|NCT01566604|FG001|Participant Flow|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
11096982|NCT01566604|OG000|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
11096983|NCT01566604|OG001|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
11096984|NCT01566604|EG000|Reported Event|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
11096985|NCT01566604|EG001|Reported Event|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
11096986|NCT01566630|BG000|Baseline|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
11096987|NCT01566630|BG001|Baseline|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
11096988|NCT01566630|BG002|Baseline|Total|Total of all reporting groups
11096989|NCT01566630|FG000|Participant Flow|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
11096990|NCT01566630|FG001|Participant Flow|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
11096991|NCT01566630|OG000|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
11096992|NCT01566630|OG001|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
11096993|NCT01566630|OG002|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
11096994|NCT01566630|OG003|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
11096995|NCT01566630|OG000|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
11096996|NCT01566630|OG001|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
11096997|NCT01566630|EG000|Reported Event|RLX030- Maternal|Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
11096998|NCT01566630|EG001|Reported Event|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
11096999|NCT01566630|EG002|Reported Event|Placebo- Maternal|Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
11097000|NCT01566630|EG003|Reported Event|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
11097001|NCT01566682|BG000|Baseline|Indeterminate Pulmonary Lesions|Patients with Pulmonary Lesions as seen by CT
11097002|NCT01566682|FG000|Participant Flow|Indeterminate Pulmonary Lesions|Patients with Pulmonary Lesions as seen by CT
11097003|NCT01566682|OG000|Outcome|Indeterminate Pulmonary Lesions|Patients with Pulmonary Lesions as seen by CT
11097004|NCT01566682|EG000|Reported Event|Indeterminate Pulmonary Lesions|Patients with Pulmonary Lesions as seen by CT
11097005|NCT01566721|BG000|Baseline|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097006|NCT01566721|BG001|Baseline|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097007|NCT01566721|BG002|Baseline|Total|Total of all reporting groups
11097008|NCT01566721|FG000|Participant Flow|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097009|NCT01566721|FG001|Participant Flow|Cohort B: SC Herceptin by Single-Use Injection Device (SID)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097010|NCT01566721|OG000|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097011|NCT01566721|OG001|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097012|NCT01566721|OG000|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
11097013|NCT01566721|OG001|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097014|NCT01566721|OG002|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097015|NCT01566721|OG000|Outcome|Cohort B: SC Herceptin by SID (Self- Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
11097016|NCT01566721|OG001|Outcome|Cohort B: SC Herceptin by SIDE|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097017|NCT01566721|EG000|Reported Event|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097018|NCT01566721|EG001|Reported Event|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097019|NCT01566721|EG002|Reported Event|Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
11097020|NCT01566721|EG003|Reported Event|Cohort B: SC Herceptin by SID Safety Follow-up|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
11097021|NCT01566773|BG000|Baseline|All Subjects|All Subjects
11097022|NCT01566773|FG000|Participant Flow|All Subjects|
11097023|NCT01566773|OG000|Outcome|GP MDI 18 µg BID|GP MDI 18 µg BID.
11097024|NCT01566773|OG001|Outcome|GP MDI 9 µg BID|GP MDI 9 µg BID.
11097025|NCT01566773|OG002|Outcome|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
11097026|NCT01566773|OG003|Outcome|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
11097027|NCT01566773|OG004|Outcome|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
11097028|NCT01566773|OG005|Outcome|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
11097029|NCT01566773|OG006|Outcome|Placebo MDI|Placebo MDI.
11097030|NCT01566773|OG007|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
11097031|NCT01566773|OG006|Outcome|Spiriva® Handihaler®|Spiriva® Handihaler® (Tiotropium Bromide).
11097032|NCT01566773|OG007|Outcome|Spiriva Respimat|Spiriva Respimat 18 µg
11097033|NCT01566773|EG000|Reported Event|GP MDI 18 µg BID|GP MDI 18 µg BID.
11097034|NCT01566773|EG001|Reported Event|GP MDI 9 µg BID|GP MDI 9 µg BID.
11097035|NCT01566773|EG002|Reported Event|GP MDI 4.6 µg BID|GP MDI 4.6 µg BID.
11097036|NCT01566773|EG003|Reported Event|GP MDI 2.4 µg BID|GP MDI 2.4 µg BID.
11097037|NCT01566773|EG004|Reported Event|GP MDI 1.2 µg BID|GP MDI 1.2 µg BID.
11097038|NCT01566773|EG005|Reported Event|GP MDI 0.6 µg BID|GP MDI 0.6 µg BID.
11097039|NCT01566773|EG006|Reported Event|Placebo MDI|Placebo MDI.
11097040|NCT01566773|EG007|Reported Event|Spiriva 18 µg|Spiriva 18 µg
11097041|NCT01566838|BG000|Baseline|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
11097042|NCT01566838|BG001|Baseline|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
11097043|NCT01566838|BG002|Baseline|Total|Total of all reporting groups
11097044|NCT01566838|FG000|Participant Flow|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
11097045|NCT01566838|FG001|Participant Flow|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
11097046|NCT01566838|OG000|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
11097047|NCT01566838|OG001|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
11097048|NCT01566838|EG000|Reported Event|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
11097049|NCT01566838|EG001|Reported Event|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
11097050|NCT01566981|BG000|Baseline|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
11097051|NCT01566981|BG001|Baseline|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
11097052|NCT01566981|BG002|Baseline|Total|Total of all reporting groups
11097053|NCT01566981|FG000|Participant Flow|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
11097054|NCT01566981|FG001|Participant Flow|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up, so 54 patients were included in final analysis."
11097055|NCT01566981|OG000|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
11097056|NCT01566981|OG001|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
11097057|NCT01566981|OG000|Outcome|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
11097058|NCT01566981|OG001|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
11097059|NCT01566981|EG000|Reported Event|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis"
11097060|NCT01566981|EG001|Reported Event|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis."
11097061|NCT01567020|BG000|Baseline|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097062|NCT01567020|BG001|Baseline|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097063|NCT01567020|BG002|Baseline|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097064|NCT01567020|BG003|Baseline|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097065|NCT01567020|BG004|Baseline|Total|Total of all reporting groups
11097066|NCT01567020|FG000|Participant Flow|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097067|NCT01567020|FG001|Participant Flow|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097068|NCT01567020|FG002|Participant Flow|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097069|NCT01567020|FG003|Participant Flow|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097070|NCT01567020|OG000|Outcome|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097071|NCT01567020|OG001|Outcome|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097072|NCT01567020|OG002|Outcome|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097073|NCT01567020|OG003|Outcome|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097074|NCT01567020|EG000|Reported Event|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097075|NCT01567020|EG001|Reported Event|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097076|NCT01567020|EG002|Reported Event|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097077|NCT01567020|EG003|Reported Event|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
11097078|NCT01567085|BG000|Baseline|Eculizumab|"All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion.~Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.~Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days."
11097079|NCT01567085|FG000|Participant Flow|Eculizumab|"All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion.~Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.~Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days."
11097080|NCT01567085|OG000|Outcome|Eculizumab|"All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion.~Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.~Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days."
11097081|NCT01567085|EG000|Reported Event|Eculizumab|"All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion.~Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.~Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days."
11097082|NCT01567150|BG000|Baseline|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
11097083|NCT01567150|BG001|Baseline|Control|Control is treatment without novel dressing
11097084|NCT01567150|BG002|Baseline|Total|Total of all reporting groups
11097085|NCT01567150|FG000|Participant Flow|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
11097086|NCT01567150|FG001|Participant Flow|Control|Control is treatment without novel dressing
11097087|NCT01567150|OG000|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
11097088|NCT01567150|OG001|Outcome|Control|Control is treatment without novel dressing
11097089|NCT01567150|EG000|Reported Event|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
11097090|NCT01567150|EG001|Reported Event|Control|Control is treatment without novel dressing
11097091|NCT01567163|BG000|Baseline|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
11097092|NCT01567163|FG000|Participant Flow|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
11097093|NCT01567163|OG000|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
11097094|NCT01567163|OG000|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
11328396|NCT03426995|EG005|Reported Event|Part A: GSK3358699 25 mg SD|Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
11097095|NCT01567163|OG000|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
11097096|NCT01567163|OG000|Outcome|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
11097097|NCT01567163|OG000|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
11328397|NCT03426995|EG006|Reported Event|Part A: GSK3358699 30 mg SD|Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
11097098|NCT01567163|OG000|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
11097099|NCT01567163|EG000|Reported Event|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
11097100|NCT01567306|BG000|Baseline|Allergovac Depot Group 1 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097101|NCT01567306|BG001|Baseline|Allergovac Depot Group 2 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097102|NCT01567306|BG002|Baseline|Allergovac Depot Group 3 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097103|NCT01567306|BG003|Baseline|Allergovac Depot Group 4 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097104|NCT01567306|BG004|Baseline|Allergovac Depot Group 5 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097105|NCT01567306|BG005|Baseline|Placebo - Group 6|Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097106|NCT01567306|BG006|Baseline|Total|Total of all reporting groups
11097107|NCT01567306|FG000|Participant Flow|Allergovac Depot Group 1 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097108|NCT01567306|FG001|Participant Flow|Allergovac Depot Group 2 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097109|NCT01567306|FG002|Participant Flow|Allergovac Depot Group 3 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097110|NCT01567306|FG003|Participant Flow|Allergovac Depot Group 4 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097111|NCT01567306|FG004|Participant Flow|Allergovac Depot Group 5 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097112|NCT01567306|FG005|Participant Flow|Placebo - Group 6|Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097113|NCT01567306|OG000|Outcome|Allergovac Depot Group 1 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097114|NCT01567306|OG001|Outcome|Allergovac Depot Group 2 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097115|NCT01567306|OG002|Outcome|Allergovac Depot Group 3 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097116|NCT01567306|OG003|Outcome|Allergovac Depot Group 4 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097117|NCT01567306|OG004|Outcome|Allergovac Depot Group 5 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
10834228|NCT00160251|OG003|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
11097118|NCT01567306|OG005|Outcome|Placebo - Group 6|Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097119|NCT01567306|EG000|Reported Event|Allergovac Depot Group 1 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097120|NCT01567306|EG001|Reported Event|Allergovac Depot Group 2 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097121|NCT01567306|EG002|Reported Event|Allergovac Depot Group 3 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097122|NCT01567306|EG003|Reported Event|Allergovac Depot Group 4 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097123|NCT01567306|EG004|Reported Event|Allergovac Depot Group 5 Active|Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097124|NCT01567306|EG005|Reported Event|Placebo - Group 6|Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
11097125|NCT01567371|BG000|Baseline|LiDCO Rapid Monitor|
11097126|NCT01567371|FG000|Participant Flow|LiDCO Rapid Monitor|
11097127|NCT01567371|OG000|Outcome|LiDCO Rapid Monitor|
11097128|NCT01567371|EG000|Reported Event|LiDCO Rapid Monitor|
11097129|NCT01567462|BG000|Baseline|Monopolar Loop Electrocautery|Participants completed a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery and all follow up procedures.
11097130|NCT01567462|BG001|Baseline|PK Button Vaporization Electrode|Participants completed a transurethral resection of a bladder tumor using a PK button vaporization electrode and all follow up procedures.
11097131|NCT01567462|BG002|Baseline|Total|Total of all reporting groups
11097132|NCT01567462|FG000|Participant Flow|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
11097133|NCT01567462|FG001|Participant Flow|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
11097134|NCT01567462|OG000|Outcome|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
11097135|NCT01567462|OG001|Outcome|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
11097136|NCT01567462|EG000|Reported Event|Monopolar Loop Electrocautery|Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.
11097137|NCT01567462|EG001|Reported Event|PK Button Vaporization Electrode|Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
11097138|NCT01567527|BG000|Baseline|Aripiprazole Depot|Subjects received aripiprazole 300 mg or 400 mg depot intramuscularly up to 52 weeks.
11097139|NCT01567527|BG001|Baseline|Placebo|Subjects received placebo intramuscularly up to 52 weeks.
11097140|NCT01567527|BG002|Baseline|Total|Total of all reporting groups
11097141|NCT01567527|FG000|Participant Flow|Conversion Phase.|During the Oral Conversion Phase, subjects were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
11097142|NCT01567527|FG001|Participant Flow|Oral Aripiprazole Stabilization Phase.|During the Oral Stabilization Phase, subjects were stabilized on an oral dose of aripiprazole. 632 subjects entered the Oral Stabilization Phase (367 subjects entered from the Conversation Phase and 265 subjects entered the Oral Stabilization Phase directly).
11097143|NCT01567527|FG002|Participant Flow|Intramuscular (IM) Depot Stabilization Phase.|During the Depot Stabilization Phase, subjects were stabilized on aripiprazole IM depot. The subjects were assigned to aripiprazole IM depot in the IM Depot Stabilization Phase for a minimum of 12 weeks and a maximum of 28 weeks. To proceed to the Double-blind, Placebo-controlled Phase, subjects were required to meet all the protocol-defined stability criteria for a minimum of 8 consecutive weeks (4 consecutive biweekly visits).
11097144|NCT01567527|FG003|Participant Flow|Double-blind Placebo-controlled Phase - Aripiprazole IM Depot.|Subjects received aripiprazole 300 mg or 400 mg depot intramuscularly up to 52 weeks. A total of 266 subjects entered Double-blind Placebo-controlled phase. Of the 266 subjects, 133 were randomized to aripiprazole IM depot treatment. Since one subject withdrew consent to participate prior to receiving an injection, only 132 subjects received aripiprazole IM depot treatment.
11097145|NCT01567527|FG004|Participant Flow|Double-blind Placebo-controlled Phase - Placebo.|Subjects received placebo intramuscularly up to 52 weeks. A total of 266 subjects entered double-blind placebo-controlled Phase. Of the 266 subjects, 133 were randomized to placebo treatment.
11097146|NCT01567527|OG000|Outcome|Aripiprazole IM Depot|Subjects received aripiprazole 300 mg or 400 mg depot intramuscularly up to 52 weeks.
11097147|NCT01567527|OG001|Outcome|Placebo|Subjects received placebo intramuscularly up to 52 weeks.
11097148|NCT01567527|EG000|Reported Event|Conversion Phase.|During the Oral Conversion Phase, subjects were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. Received Oral aripiprazole at a target starting dose of 15 mg/day.
11097149|NCT01567527|EG001|Reported Event|Oral Aripiprazole Stabilization Phase.|Subjects received oral aripiprazole dose ranging from 15 mg to 30 mg daily.
11097150|NCT01567527|EG002|Reported Event|IM Depot Stabilization Phase.|During the depot stabilization phase, subjects were stabilized on aripiprazole depot.
11097151|NCT01567527|EG003|Reported Event|Aripiprazole IM Depot- Double-blind, Placebo-controlled Phase.|Subjects received IM depot aripiprazole 400 mg or 300 mg, once a month injection.
11097152|NCT01567527|EG004|Reported Event|Placebo-Double-blind, Placebo-controlled Phase.|Subjects received IM Depot Placebo, once a month injection.
11097153|NCT01567826|BG000|Baseline|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
11097154|NCT01567826|BG001|Baseline|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
11097155|NCT01567826|BG002|Baseline|Total|Total of all reporting groups
11097156|NCT01567826|FG000|Participant Flow|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
11097157|NCT01567826|FG001|Participant Flow|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
11097158|NCT01567826|OG000|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
11097159|NCT01567826|OG001|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
11097160|NCT01567826|OG000|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
11097161|NCT01567826|OG001|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
11097162|NCT01567826|EG000|Reported Event|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
11097163|NCT01567826|EG001|Reported Event|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
11097164|NCT01567839|BG000|Baseline|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
11097165|NCT01567839|FG000|Participant Flow|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
11097166|NCT01567839|OG000|Outcome|4% Articaine With 1:100,000 Epinephrine|
11097167|NCT01567839|OG001|Outcome|4% Lidocaine With 1:100,000 Epinephrine|
11328398|NCT03426995|EG007|Reported Event|Part A: GSK3358699 40 mg SD|Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
11328399|NCT03426995|EG008|Reported Event|Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328400|NCT03426995|EG009|Reported Event|Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed|Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
11328401|NCT03426995|EG010|Reported Event|Part C: Cohort 4 and 5- Placebo RD|Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328402|NCT03426995|EG011|Reported Event|Part C: Cohort 4 and 5- GSK3358699 10 mg RD|Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
11328403|NCT03426995|EG012|Reported Event|Part C: Cohort 6- GSK3358699 or Placebo RD|Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328404|NCT03426995|EG013|Reported Event|Part C: Cohort 7- GSK3358699 or Placebo RD|Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
11328405|NCT03426995|EG014|Reported Event|Part C: Cohort 8- GSK3358699 or Placebo RD|Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
10834229|NCT00160251|OG004|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
11328406|NCT03427073|BG000|Baseline|Cohort 1 - ALM201|One patient received 10 mg IMP from cycle 1 through cycle 6.
11328407|NCT03427073|BG001|Baseline|Cohort 2 - ALM201|One patient received 20 mg IMP in cycle 1 and cycle 2.
10834230|NCT00160251|OG000|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834231|NCT00160251|OG001|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834232|NCT00160251|OG002|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
11328408|NCT03427073|BG002|Baseline|Cohort 3 - ALM201|One patient received 40 mg IMP from cycle 1 through cycle 3.
11328409|NCT03427073|BG003|Baseline|Cohort 4 - ALM201|Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
11328410|NCT03427073|BG004|Baseline|Cohort 5 - ALM201|Three patients received 160 mg of IMP in cycles 1 and 2.
11328411|NCT03427073|BG005|Baseline|Cohort 6 - ALM201|Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
11328412|NCT03427073|BG006|Baseline|Cohort 7 - ALM201|Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
11328413|NCT03427073|BG007|Baseline|Cohort 8 - ALM201|Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
11328414|NCT03427073|BG008|Baseline|Total|Total of all reporting groups
11328415|NCT03427073|FG000|Participant Flow|Cohort 1 - ALM201|One patient received 10 mg IMP from cycle 1 through cycle 6.
11328416|NCT03427073|FG001|Participant Flow|Cohort 2 - ALM201|One patient received 20 mg IMP in cycle 1 and cycle 2.
11328417|NCT03427073|FG002|Participant Flow|Cohort 3 - ALM201|One patient received 40 mg IMP from cycle 1 through cycle 3.
11328418|NCT03427073|FG003|Participant Flow|Cohort 4 - ALM201|Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
11328419|NCT03427073|FG004|Participant Flow|Cohort 5 - ALM201|Three patients received 160 mg of IMP in cycles 1 and 2.
11328420|NCT03427073|FG005|Participant Flow|Cohort 6 - ALM201|Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
11328421|NCT03427073|FG006|Participant Flow|Cohort 7 - ALM201|Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
11328422|NCT03427073|FG007|Participant Flow|Cohort 8 - ALM201|Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
11328423|NCT03427073|OG000|Outcome|Cohort 1 - ALM201|One patient received 10 mg IMP from cycle 1 through cycle 6.
11328424|NCT03427073|OG001|Outcome|Cohort 2 - ALM201|One patient received 20 mg IMP in cycle 1 and cycle 2.
11328425|NCT03427073|OG002|Outcome|Cohort 3 - ALM201|One patient received 40 mg IMP from cycle 1 through cycle 3.
11328426|NCT03427073|OG003|Outcome|Cohort 4 - ALM201|Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
11328427|NCT03427073|OG004|Outcome|Cohort 5 - ALM201|Three patients received 160 mg of IMP in cycles 1 and 2.
11328428|NCT03427073|OG005|Outcome|Cohort 6 - ALM201|Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
11328429|NCT03427073|OG006|Outcome|Cohort 7 - ALM201|Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
11328430|NCT03427073|OG007|Outcome|Cohort 8 - ALM201|Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
11097168|NCT01567839|OG002|Outcome|4% Prilocaine With 1:200,000 Epinephrine|
11097169|NCT01567839|EG000|Reported Event|4% Articaine With 1:100,000 Epinephrine|
11097170|NCT01567839|EG001|Reported Event|4% Lidocaine With 1:100,000 Epinephrine|
11097171|NCT01567839|EG002|Reported Event|4% Prilocaine With 1:200,000 Epinephrine|
11097172|NCT01567852|BG000|Baseline|Ketamine First|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
11097173|NCT01567852|BG001|Baseline|Methohexital First|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
11097174|NCT01567852|BG002|Baseline|Total|Total of all reporting groups
11097175|NCT01567852|FG000|Participant Flow|Ketamine Then Methohexital (Alternating Each Trial)|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
11097176|NCT01567852|FG001|Participant Flow|Methohexital Then Ketamine (Alternating Each Trial)|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
11097177|NCT01567852|OG000|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
11097178|NCT01567852|OG001|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
11097179|NCT01567852|EG000|Reported Event|Ketamine Inductions|Number of trials receiving ketamine inductions. Each trial is one induction.
11097180|NCT01567852|EG001|Reported Event|Methohexital Inductions|Number of trials receiving methohexital inductions. Each trial is one induction
11097181|NCT01567865|BG000|Baseline|Reference Lot|"Lot of Vaccine produced in existing facility~Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097182|NCT01567865|BG001|Baseline|New Lot #1|"First lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097183|NCT01567865|BG002|Baseline|New Lot #2|"Second lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097184|NCT01567865|BG003|Baseline|New Lot #3|"Third lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097185|NCT01567865|BG004|Baseline|Total|Total of all reporting groups
11097186|NCT01567865|FG000|Participant Flow|Reference Lot|"Lot of Vaccine produced in existing facility~Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097187|NCT01567865|FG001|Participant Flow|New Lot #1|"First lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097188|NCT01567865|FG002|Participant Flow|New Lot #2|"Second lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097189|NCT01567865|FG003|Participant Flow|New Lot #3|"Third lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097190|NCT01567865|OG000|Outcome|Reference Lot|"Lot of Vaccine produced in existing facility~Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097191|NCT01567865|OG001|Outcome|New Lot #1|"First lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097192|NCT01567865|OG002|Outcome|New Lot #2|"Second lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097193|NCT01567865|OG003|Outcome|New Lot #3|"Third lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097194|NCT01567865|OG004|Outcome|All New Lots|All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
11097195|NCT01567865|EG000|Reported Event|Reference Lot|"Lot of Vaccine produced in existing facility~Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097196|NCT01567865|EG001|Reported Event|New Lot #1|"First lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097197|NCT01567865|EG002|Reported Event|New Lot #2|"Second lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097198|NCT01567865|EG003|Reported Event|New Lot #3|"Third lot of vaccine produced in new facility~Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China"
11097199|NCT01567891|BG000|Baseline|NY-ESO-1ᶜ²⁵⁹T|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
11097200|NCT01567891|FG000|Participant Flow|NY-ESO-1ᶜ²⁵⁹T Cells Administered Intravenously|Participants who received cytoreductive chemotherapy followed by Lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5 billion cells)
11097201|NCT01567891|OG000|Outcome|NY-ESO-1ᶜ²⁵⁹T|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
11097202|NCT01567891|OG000|Outcome|NY-ESO-1ᶜ²⁵⁹T|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097203|NCT01567891|OG000|Outcome|Manufactured Product -Mean % CD4+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097204|NCT01567891|OG001|Outcome|Week 4 Post-treatment- Mean % CD4+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097205|NCT01567891|OG002|Outcome|Week 8 Post-treatment - Mean % CD4+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097206|NCT01567891|OG003|Outcome|Manufactured Product - Mean % CD8+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097207|NCT01567891|OG004|Outcome|Week 4 Post-treatment - Mean % CD8+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097208|NCT01567891|OG005|Outcome|Week 8 Post-treatment - Mean % CD8+Pentamer+|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097209|NCT01567891|OG000|Outcome|Subject 1|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097210|NCT01567891|OG001|Outcome|Subject 2|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097211|NCT01567891|EG000|Reported Event|NY-ESO-1ᶜ²⁵⁹T|Participants who received NY-ESO-1ᶜ²⁵⁹T
11097212|NCT01567943|BG000|Baseline|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
11097213|NCT01567943|BG001|Baseline|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
11097214|NCT01567943|BG002|Baseline|Total|Total of all reporting groups
11097215|NCT01567943|FG000|Participant Flow|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
11097216|NCT01567943|FG001|Participant Flow|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
11097217|NCT01567943|FG002|Participant Flow|Pre-randomization Drop-out|These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.
11097218|NCT01567943|OG000|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
11097219|NCT01567943|OG001|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
11097220|NCT01567943|EG000|Reported Event|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
11097221|NCT01567943|EG001|Reported Event|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
11097222|NCT01568008|BG000|Baseline|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
11097223|NCT01568008|FG000|Participant Flow|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
11097224|NCT01568008|OG000|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
11097225|NCT01568008|EG000|Reported Event|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
11097226|NCT01568021|BG000|Baseline|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
11097227|NCT01568021|FG000|Participant Flow|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
11097228|NCT01568021|OG000|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
11097229|NCT01568021|EG000|Reported Event|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
11097230|NCT01568034|BG000|Baseline|Overall Study|The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
11097231|NCT01568034|FG000|Participant Flow|Treatment Sequence A|"Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
11097232|NCT01568034|FG001|Participant Flow|Treatment Sequence B|"Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
11097233|NCT01568034|FG002|Participant Flow|Treatment Sequence C|"Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
11097234|NCT01568034|FG003|Participant Flow|Treatment Sequence D|"Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
11097235|NCT01568034|OG000|Outcome|Placebo|PLC, Placebo
11097236|NCT01568034|OG001|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
11097237|NCT01568034|OG002|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
11097238|NCT01568034|OG003|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
11097239|NCT01568034|EG000|Reported Event|25 mg BIA 9-1067|25 mg BIA 9-1067 ESL, Eslicarbazepine
11097240|NCT01568034|EG001|Reported Event|50 mg BIA 9-1067|50 mg BIA 9-1067 ESL, Eslicarbazepine
11097241|NCT01568034|EG002|Reported Event|100 mg BIA 9-1067|100 mg BIA 9-1067 ESL, Eslicarbazepine
11097242|NCT01568034|EG003|Reported Event|Placebo|Placebo ESL, Eslicarbazepine
11097243|NCT01568047|BG000|Baseline|Placebo|PLC, Placebo
11097244|NCT01568047|BG001|Baseline|BIA 9-1067 (5 mg)|5 mg BIA 9-1067 - OPC, Opicapone
11097245|NCT01568047|BG002|Baseline|BIA 9-1067 (15 mg)|15 mg BIA 9-1067 - OPC, Opicapone
11097246|NCT01568047|BG003|Baseline|BIA 9-1067 (30 mg)|30 mg BIA 9-1067 - OPC, Opicapone
11097247|NCT01568047|BG004|Baseline|Total|Total of all reporting groups
11097248|NCT01568047|FG000|Participant Flow|Placebo|PLC, Placebo
11097249|NCT01568047|FG001|Participant Flow|BIA 9-1067 (5 mg)|OPC, Opicapone
11097250|NCT01568047|FG002|Participant Flow|BIA 9-1067 (15 mg)|OPC, Opicapone
11097251|NCT01568047|FG003|Participant Flow|BIA 9-1067 (30 mg)|OPC, Opicapone
11097252|NCT01568047|OG000|Outcome|Placebo|PLC, Placebo
11097253|NCT01568047|OG001|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
11097254|NCT01568047|OG002|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
11097255|NCT01568047|OG003|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
11097256|NCT01568047|EG000|Reported Event|Placebo|Placebo, PLC
11097257|NCT01568047|EG001|Reported Event|BIA 9-1067 (5 mg)|5 mg BIA 9-1067, OPC, Opicapone
11097258|NCT01568047|EG002|Reported Event|BIA 9-1067 (15 mg)|15 mg BIA 9-1067, OPC, Opicapone
11097259|NCT01568047|EG003|Reported Event|BIA 9-1067 (30 mg)|30 mg BIA 9-1067, OPC, Opicapone
11097260|NCT01568073|BG000|Baseline|Placebo|Placebo 200 mg
11097261|NCT01568073|BG001|Baseline|Entacapone|Entacapone - 200 mg
11097262|NCT01568073|BG002|Baseline|OPC 5mg|OPC, Opicapone 5mg
11097263|NCT01568073|BG003|Baseline|OPC 25mg|OPC, Opicapone 25mg
11097264|NCT01568073|BG004|Baseline|OPC 50mg|OPC, Opicapone 50mg
11097265|NCT01568073|BG005|Baseline|Total|Total of all reporting groups
11097266|NCT01568073|FG000|Participant Flow|Placebo|Placebo 200 mg
11097267|NCT01568073|FG001|Participant Flow|Entacapone|Entacapone - 200 mg
11097268|NCT01568073|FG002|Participant Flow|OPC 5mg|OPC, Opicapone 5mg
11097269|NCT01568073|FG003|Participant Flow|OPC 25mg|OPC, Opicapone 25mg
11097270|NCT01568073|FG004|Participant Flow|OPC 50mg|OPC, Opicapone 50mg
11097271|NCT01568073|OG000|Outcome|Placebo|Placebo 200 mg
11097272|NCT01568073|OG001|Outcome|Entacapone|Entacapone - 200 mg
11097273|NCT01568073|OG002|Outcome|OPC 5mg|OPC, Opicapone 5mg
11097274|NCT01568073|OG003|Outcome|OPC 25mg|OPC, Opicapone 25mg
11097275|NCT01568073|OG004|Outcome|OPC 50mg|OPC, Opicapone 50mg
11097276|NCT01568073|EG000|Reported Event|Placebo|Placebo 200 mg
11097277|NCT01568073|EG001|Reported Event|Entacapone|Entacapone - 200 mg
11097278|NCT01568073|EG002|Reported Event|OPC 5mg|OPC, Opicapone 5mg
11097279|NCT01568073|EG003|Reported Event|OPC 25mg|OPC, Opicapone 25mg
11097280|NCT01568073|EG004|Reported Event|OPC 50mg|OPC, Opicapone 50mg
11097281|NCT01568112|BG000|Baseline|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
11097282|NCT01568112|BG001|Baseline|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
11097283|NCT01568112|BG002|Baseline|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
11097284|NCT01568112|BG003|Baseline|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
11097285|NCT01568112|BG004|Baseline|Total|Total of all reporting groups
11097286|NCT01568112|FG000|Participant Flow|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
11097287|NCT01568112|FG001|Participant Flow|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
11097288|NCT01568112|FG002|Participant Flow|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
11097289|NCT01568112|FG003|Participant Flow|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
11097290|NCT01568112|OG000|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
11097291|NCT01568112|OG001|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
11097292|NCT01568112|OG002|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
11328431|NCT03427073|EG000|Reported Event|Cohort 1 - ALM201|One patient received 10 mg IMP from cycle 1 through cycle 6.
11097293|NCT01568112|OG003|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
11097294|NCT01568112|OG003|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
11097295|NCT01568112|EG000|Reported Event|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
11097296|NCT01568112|EG001|Reported Event|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
11097297|NCT01568112|EG002|Reported Event|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
11097298|NCT01568112|EG003|Reported Event|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
11097299|NCT01568255|BG000|Baseline|Vitamin D Treatment|"Vitamin D Treatment Group~Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks"
11097300|NCT01568255|BG001|Baseline|Placebo Group|"Placebo at 50,000IU for 8 weeks~Placebo: placebo at 50,000IU for 8 weeks"
11097301|NCT01568255|BG002|Baseline|Total|Total of all reporting groups
11097302|NCT01568255|FG000|Participant Flow|Vitamin D Treatment|"Vitamin D Treatment Group~Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks"
11097303|NCT01568255|FG001|Participant Flow|Placebo Group|"Placebo at 50,000IU for 8 weeks~Placebo: placebo at 50,000IU for 8 weeks"
11097304|NCT01568255|OG000|Outcome|Vitamin D Treatment|"Vitamin D Treatment Group~Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks"
11097305|NCT01568255|OG001|Outcome|Placebo Group|"Placebo at 50,000IU for 8 weeks~Placebo: placebo at 50,000IU for 8 weeks"
11097306|NCT01568255|EG000|Reported Event|Vitamin D Treatment Group|"Vitamin D Treatment Group~Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks"
11097307|NCT01568255|EG001|Reported Event|Placebo Group|"Placebo at 50,000IU for 8 weeks~Placebo: placebo at 50,000IU for 8 weeks"
11097308|NCT01568320|BG000|Baseline|Endovascular|"Endovascular Treatment (Zenith)~Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta."
11097309|NCT01568320|FG000|Participant Flow|Endovascular|"Endovascular Treatment (Zenith)~Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta."
11097310|NCT01568320|OG000|Outcome|Endovascular|"Endovascular Treatment (Zenith)~Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta."
11097311|NCT01568320|EG000|Reported Event|Endovascular|"Endovascular Treatment (Zenith)~Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta."
11097316|NCT01568528|BG000|Baseline|Healthy Controls|Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
11097317|NCT01568528|BG001|Baseline|Oxytocin|Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
11097318|NCT01568528|BG002|Baseline|Placebo|Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
11097319|NCT01568528|BG003|Baseline|Total|Total of all reporting groups
11097320|NCT01568528|FG000|Participant Flow|Healthy Controls|Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
11097321|NCT01568528|FG001|Participant Flow|Oxytocin Arm|Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
11097322|NCT01568528|FG002|Participant Flow|Placebo Arm|Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
11097323|NCT01568528|OG000|Outcome|Healthy Controls|Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
11097324|NCT01568528|OG001|Outcome|Oxytocin|Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
11097325|NCT01568528|OG002|Outcome|Placebo|Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
11097326|NCT01568528|EG000|Reported Event|Healthy Controls|Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
11097327|NCT01568528|EG001|Reported Event|Oxytocin|Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
11097328|NCT01568528|EG002|Reported Event|Placebo|Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
11097329|NCT01568593|BG000|Baseline|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
11097330|NCT01568593|BG001|Baseline|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
11097331|NCT01568593|BG002|Baseline|Total|Total of all reporting groups
11097332|NCT01568593|FG000|Participant Flow|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
11097333|NCT01568593|FG001|Participant Flow|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
11097334|NCT01568593|OG000|Outcome|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
11097335|NCT01568593|OG001|Outcome|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
11097336|NCT01568593|EG000|Reported Event|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
11097337|NCT01568593|EG001|Reported Event|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
11097338|NCT01568606|BG000|Baseline|Body Composition Analysis InBody Scale|Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
11097339|NCT01568606|FG000|Participant Flow|Body Composition Analysis InBody Scale|Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
11097340|NCT01568606|OG000|Outcome|Body Composition Analysis InBody Scale|Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale.
11097341|NCT01568606|EG000|Reported Event|Body Composition Analysis InBody Scale|Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
11097342|NCT01568827|BG000|Baseline|Black-raspberry Powder|Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
11097343|NCT01568827|BG001|Baseline|No Intervention|Water without lypholized black raspberry powder
11097344|NCT01568827|BG002|Baseline|Total|Total of all reporting groups
11097345|NCT01568827|FG000|Participant Flow|Water First, Then Washout, Then Blackraspberry Slurry|8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
11097346|NCT01568827|FG001|Participant Flow|Blackraspberry Slurry First, Then Washout, Then Water|Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
11097347|NCT01568827|OG000|Outcome|Water|Water without lypholized black raspberry powder
11097348|NCT01568827|OG001|Outcome|Blackraspberry Slurry|Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
11097349|NCT01568827|EG000|Reported Event|Black-raspberry Slurry, Washout, Water|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
11097350|NCT01568827|EG001|Reported Event|Water, Washout, Black-raspberry Slurry|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
11097351|NCT01568866|BG000|Baseline|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
11097352|NCT01568866|BG001|Baseline|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
11097353|NCT01568866|BG002|Baseline|Total|Total of all reporting groups
11097354|NCT01568866|FG000|Participant Flow|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
11097355|NCT01568866|FG001|Participant Flow|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
11097356|NCT01568866|OG000|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
11328432|NCT03427073|EG001|Reported Event|Cohort 2 - ALM201|One patient received 20 mg IMP in cycle 1 and cycle 2.
11328433|NCT03427073|EG002|Reported Event|Cohort 3 - ALM201|One patient received 40 mg IMP from cycle 1 through cycle 3.
11097357|NCT01568866|OG001|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
11097358|NCT01568866|EG000|Reported Event|Bortezomib|
11097359|NCT01568866|EG001|Reported Event|Carfilzomib|
11097360|NCT01568892|BG000|Baseline|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097361|NCT01568892|BG001|Baseline|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097362|NCT01568892|BG002|Baseline|Total|Total of all reporting groups
11097363|NCT01568892|FG000|Participant Flow|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097364|NCT01568892|FG001|Participant Flow|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097365|NCT01568892|OG000|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097366|NCT01568892|OG001|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097367|NCT01568892|OG000|Outcome|Overall Study Arm|All the participants who received DTG 50 mg BID.
11097368|NCT01568892|EG000|Reported Event|DTG 50mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097369|NCT01568892|EG001|Reported Event|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
11097370|NCT01568905|BG000|Baseline|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week
11097371|NCT01568905|BG001|Baseline|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
11097372|NCT01568905|BG002|Baseline|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week
11097373|NCT01568905|BG003|Baseline|Total|Total of all reporting groups
11097374|NCT01568905|FG000|Participant Flow|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
11097375|NCT01568905|FG001|Participant Flow|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
11097376|NCT01568905|FG002|Participant Flow|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
11097377|NCT01568905|OG000|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
11097378|NCT01568905|OG001|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
11097379|NCT01568905|OG002|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
11097380|NCT01568905|EG000|Reported Event|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
11097381|NCT01568905|EG001|Reported Event|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
11097382|NCT01568905|EG002|Reported Event|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
11097383|NCT01568944|BG000|Baseline|Oral Antibiotic and Oral Rinse|"Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg~Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097384|NCT01568944|BG001|Baseline|Standard Treatment|"Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097385|NCT01568944|BG002|Baseline|Total|Total of all reporting groups
11097386|NCT01568944|FG000|Participant Flow|Oral Antibiotic and Oral Rinse|"Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg~Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097387|NCT01568944|FG001|Participant Flow|Standard Treatment|"Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097388|NCT01568944|OG000|Outcome|Oral Antibiotic and Oral Rinse|"Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg~Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097389|NCT01568944|OG001|Outcome|Standard Treatment|"Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097390|NCT01568944|EG000|Reported Event|Oral Antibiotic and Oral Rinse|"Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg~Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097391|NCT01568944|EG001|Reported Event|Standard Treatment|"Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers~Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers"
11097392|NCT01569022|BG000|Baseline|All Study Participants|"Participants were asked to acclimate to CPAP and MAD for 4 weeks (total) during which adjustments to both modes of therapy are made aiming to optimize comfort and abolish snoring.~If the interface was found to be uncomfortable, the patient was given the opportunity to change the mask. None of the participants was exposed to dual therapy or had access to both devices at the same time. Weekly phone calls were made to inquire about side effects or problems with CPAP or MAD. At the end of the acclimatization period, patients underwent a 2-week washout, after which they were randomly assigned in 1:1 ratio via a presealed and numbered opaque white envelope to one of the two treatment modalities (CPAP or MAD) that included the assignment to receive 12 weeks of treatment with MAD and CPAP in alternating order"
11097393|NCT01569022|FG000|Participant Flow|CPAP First, MAD|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks"
11097394|NCT01569022|FG001|Participant Flow|MAD First, CPAP|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks"
11097395|NCT01569022|OG000|Outcome|CPAP|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks"
11097396|NCT01569022|OG001|Outcome|Mandibular Advancing Device|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks"
11097397|NCT01569022|OG000|Outcome|CPAP|CPAP treatment for 12 weeks
11097398|NCT01569022|OG001|Outcome|Mandibular Advancing Device|Mandibular advancing device treatment for 12 weeks
11097399|NCT01569022|EG000|Reported Event|CPAP|"CPAP treatment for sleep apnea~CPAP: CPAP Treatment for 12 weeks"
11097400|NCT01569022|EG001|Reported Event|Mandibular Advancing Device|"MAD treatment for sleep apnea~MAD: MAD Treatment for 12 weeks"
11097401|NCT01569074|BG000|Baseline|FOSTA 100 MG BID PO|Dosing Group A
11097402|NCT01569074|BG001|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11097403|NCT01569074|BG002|Baseline|FOSTA 75 MG BID PO|Dosing Group C
11097404|NCT01569074|BG003|Baseline|FOSTA 50 MG BID PO|Dosing Group D
11097405|NCT01569074|BG004|Baseline|PLACEBO PO|Dosing Group E
11097406|NCT01569074|BG005|Baseline|Total|Total of all reporting groups
11097407|NCT01569074|FG000|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
11097408|NCT01569074|FG001|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11097409|NCT01569074|FG002|Participant Flow|FOSTA 75 MG BID PO|Dosing Group C
11097410|NCT01569074|FG003|Participant Flow|FOSTA 50 MG BID PO|Dosing Group D
11097411|NCT01569074|FG004|Participant Flow|PLACEBO PO|Dosing Group E
11097412|NCT01569074|OG000|Outcome|FOSTA 100 MG BID PO|Dosing Group A
11097413|NCT01569074|OG001|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11097414|NCT01569074|OG002|Outcome|FOSTA 75 MG BID PO|Dosing Group C
11097415|NCT01569074|OG003|Outcome|FOSTA 50 MG BID PO|Dosing Group D
11097416|NCT01569074|OG004|Outcome|PLACEBO PO|Dosing Group E
11097417|NCT01569074|OG000|Outcome|FOSTA 75 MG BID PO|Dosing Group C
11097418|NCT01569074|OG001|Outcome|FOSTA 50 MG BID PO|Dosing Group D
11097419|NCT01569074|OG002|Outcome|PLACEBO PO|Dosing Group E
11097420|NCT01569074|OG003|Outcome|FOSTA 100 MG BID PO|Dosing Group A
11097421|NCT01569074|EG000|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
11097422|NCT01569074|EG001|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
11097423|NCT01569074|EG002|Reported Event|FOSTA 50 MG BID PO|Dosing Group D
11097424|NCT01569074|EG003|Reported Event|FOSTA 75 MG BID PO|Dosing Group C
11097425|NCT01569074|EG004|Reported Event|PLACEBO PO|Dosing Group E
11097426|NCT01569087|BG000|Baseline|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097427|NCT01569087|BG001|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097428|NCT01569087|BG002|Baseline|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
11097429|NCT01569087|BG003|Baseline|Total|Total of all reporting groups
11097430|NCT01569087|FG000|Participant Flow|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097431|NCT01569087|FG001|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097432|NCT01569087|FG002|Participant Flow|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
11097433|NCT01569087|OG000|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097434|NCT01569087|OG001|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097435|NCT01569087|OG002|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
11097436|NCT01569087|EG000|Reported Event|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097437|NCT01569087|EG001|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
11097438|NCT01569087|EG002|Reported Event|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
10834233|NCT00160251|OG003|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
11097439|NCT01569126|BG000|Baseline|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097440|NCT01569126|BG001|Baseline|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097441|NCT01569126|BG002|Baseline|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
11097442|NCT01569126|BG003|Baseline|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097443|NCT01569126|BG004|Baseline|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097444|NCT01569126|BG005|Baseline|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097445|NCT01569126|BG006|Baseline|Total|Total of all reporting groups
11097446|NCT01569126|FG000|Participant Flow|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097447|NCT01569126|FG001|Participant Flow|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097448|NCT01569126|FG002|Participant Flow|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
11097449|NCT01569126|FG003|Participant Flow|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097450|NCT01569126|FG004|Participant Flow|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097451|NCT01569126|FG005|Participant Flow|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097452|NCT01569126|OG000|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097453|NCT01569126|OG001|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097454|NCT01569126|OG002|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
11097455|NCT01569126|OG000|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097456|NCT01569126|OG001|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097457|NCT01569126|OG002|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097458|NCT01569126|OG000|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097459|NCT01569126|OG001|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097460|NCT01569126|OG003|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097461|NCT01569126|OG004|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097462|NCT01569126|OG005|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097463|NCT01569126|EG000|Reported Event|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097464|NCT01569126|EG001|Reported Event|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
11097465|NCT01569126|EG002|Reported Event|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
11097466|NCT01569126|EG003|Reported Event|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097467|NCT01569126|EG004|Reported Event|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097468|NCT01569126|EG005|Reported Event|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
11097469|NCT01569152|BG000|Baseline|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
11097470|NCT01569152|BG001|Baseline|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
11097471|NCT01569152|BG002|Baseline|Total|Total of all reporting groups
11097472|NCT01569152|FG000|Participant Flow|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
11097473|NCT01569152|FG001|Participant Flow|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
10834234|NCT00160251|OG000|Outcome|Arm 1A: PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
11097474|NCT01569152|FG002|Participant Flow|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
11097475|NCT01569152|OG000|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
11097476|NCT01569152|OG001|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
11097477|NCT01569152|EG000|Reported Event|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
11097478|NCT01569152|EG001|Reported Event|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
11097479|NCT01569152|EG002|Reported Event|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
11097480|NCT01569191|BG000|Baseline|No Treatment / Artificial Tear / Cold Compress / Pharmaceutica|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel~ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
11097481|NCT01569191|BG001|Baseline|No Treatment / Artificial Tear / Cold Compress|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
11097482|NCT01569191|BG002|Baseline|Total|Total of all reporting groups
11097483|NCT01569191|FG000|Participant Flow|No Treatment/Artificial Tear / Cold Compress / Pharmaceutical|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel~ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist"
11097484|NCT01569191|FG001|Participant Flow|No Treatment / Artificial Tear / Cold Compress|"Exposure to grass pollen only~Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear~Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
11097485|NCT01569191|OG000|Outcome|No Treatment|Exposure to grass pollen only
11097486|NCT01569191|OG001|Outcome|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
11097487|NCT01569191|OG002|Outcome|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
11097488|NCT01569191|OG003|Outcome|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
11097489|NCT01569191|EG000|Reported Event|No Treatment|Exposure to grass pollen only
11097490|NCT01569191|EG001|Reported Event|Artificial Tear Supplement|"Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006~Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)"
11097491|NCT01569191|EG002|Reported Event|Cold Compress|"Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue~Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel"
11097492|NCT01569191|EG003|Reported Event|Anti-allergic Medication|"ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis~ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen"
11218031|NCT02318602|OG001|Outcome|Children|"Participants 2 to <12 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218032|NCT02318602|OG002|Outcome|Adolescents|"Participants 12 to <17 years of age.Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218033|NCT02318602|EG000|Reported Event|Infants|"Participants 1 to <2 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11328434|NCT03427073|EG003|Reported Event|Cohort 4 - ALM201|Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
11328435|NCT03427073|EG004|Reported Event|Cohort 5 - ALM201|Three patients received 160 mg of IMP in cycles 1 and 2.
11097493|NCT01569295|BG000|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
11097494|NCT01569295|BG001|Baseline|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
11097495|NCT01569295|BG002|Baseline|Total|Total of all reporting groups
11097496|NCT01569295|FG000|Participant Flow|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
11097497|NCT01569295|FG001|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
11097498|NCT01569295|OG000|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
11097499|NCT01569295|OG001|Outcome|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
11097500|NCT01569295|OG000|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
11097501|NCT01569295|EG000|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
11097502|NCT01569295|EG001|Reported Event|Placebo + Bendamustine + Rituximab|Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).
11097503|NCT01569438|BG000|Baseline|Gefapixant|Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
11097504|NCT01569438|BG001|Baseline|Placebo|Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
11097505|NCT01569438|BG002|Baseline|Total|Total of all reporting groups
11097506|NCT01569438|FG000|Participant Flow|Placebo|Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
11097507|NCT01569438|FG001|Participant Flow|Gefapixant|Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
11097508|NCT01569438|OG000|Outcome|Gefapixant|Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
11097509|NCT01569438|OG001|Outcome|Placebo|Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
11097510|NCT01569438|EG000|Reported Event|Placebo|Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
11097511|NCT01569438|EG001|Reported Event|Gefapixant|Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
11097512|NCT01569451|BG000|Baseline|Glatiramer Acetate Therapy (GA)|"Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097513|NCT01569451|BG001|Baseline|Rituximab + Glatiramer Acetate Therapy (R-GA)|"Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097514|NCT01569451|BG002|Baseline|Total|Total of all reporting groups
11097515|NCT01569451|FG000|Participant Flow|Glatiramer Acetate Therapy (GA)|"Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097516|NCT01569451|FG001|Participant Flow|Rituximab + Glatiramer Acetate Therapy (R-GA)|"Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097517|NCT01569451|OG000|Outcome|Glatiramer Acetate Therapy (GA)|"Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097518|NCT01569451|OG001|Outcome|Rituximab + Glatiramer Acetate Therapy (R-GA)|"Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097519|NCT01569451|OG000|Outcome|(Placebo and) Glatiramer Acetate|"Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard Glatiramer Acetate therapy, 20 mg injected subcutaneously daily.~Glatiramer Acetate: 20 mg injected subcutaneously daily~Placebo: Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab or placebo (normal saline) on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily."
11097520|NCT01569451|OG001|Outcome|Rituximab and Glatiramer Acetate (R-GA)|"Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard Glatiramer Acetate therapy, 20 mg injected subcutaneously daily. There is no placebo arm.~Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097521|NCT01569451|EG000|Reported Event|Glatiramer Acetate Therapy (GA)|"Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097522|NCT01569451|EG001|Reported Event|Rituximab + Glatiramer Acetate Therapy (R-GA)|"Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.~Rituximab: intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15~Glatiramer Acetate: 20 mg injected subcutaneously daily"
11097523|NCT01569464|BG000|Baseline|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
11097524|NCT01569464|BG001|Baseline|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11097525|NCT01569464|BG002|Baseline|Total|Total of all reporting groups
11097526|NCT01569464|FG000|Participant Flow|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
11097527|NCT01569464|FG001|Participant Flow|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11097528|NCT01569464|OG000|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
11097529|NCT01569464|OG001|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11097530|NCT01569464|OG001|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11097531|NCT01569464|OG001|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11328436|NCT03427073|EG005|Reported Event|Cohort 6 - ALM201|Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
11097532|NCT01569464|EG000|Reported Event|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
11097533|NCT01569464|EG001|Reported Event|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
11097534|NCT01569529|BG000|Baseline|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
11097535|NCT01569529|BG001|Baseline|No ad Exposure|Young adults, who registered for the cessation program, one month prior to presenting the online advertisements (intervention).
11097536|NCT01569529|BG002|Baseline|Total|Total of all reporting groups
11097537|NCT01569529|FG000|Participant Flow|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
11097538|NCT01569529|FG001|Participant Flow|No Ad Exposure|Young adults, who registered for the cessation program, after arriving at the program site though established means (e.g., search engine results), one month prior to presenting the tailored online advertisements (intervention).
11097539|NCT01569529|OG000|Outcome|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
11097540|NCT01569529|OG001|Outcome|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
11097541|NCT01569529|EG000|Reported Event|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
11097542|NCT01569529|EG001|Reported Event|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
11097543|NCT01569568|BG000|Baseline|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097544|NCT01569568|BG001|Baseline|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097545|NCT01569568|BG002|Baseline|Total|Total of all reporting groups
11097546|NCT01569568|FG000|Participant Flow|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), functional magnetic resonance imaging (fMRI)~Cognitive testing: Neuropsychological testing"
11097547|NCT01569568|FG001|Participant Flow|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097548|NCT01569568|OG000|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097549|NCT01569568|OG001|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097550|NCT01569568|EG000|Reported Event|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097551|NCT01569568|EG001|Reported Event|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
11097552|NCT01569594|BG000|Baseline|Carotid Endarterectomy Subjects|CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
11097553|NCT01569594|FG000|Participant Flow|Single Arm|Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material.
11097554|NCT01569594|OG000|Outcome|Carotid Endarterectomy Subjects|CorMatrix ECM for Carotid Repair: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
11097555|NCT01569594|EG000|Reported Event|Single Arm|Subjects undergoing carotid endarterectomy with patch angioplasty closure using the CorMatrix ECM as the patch material.
11097556|NCT01569607|BG000|Baseline|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
11097557|NCT01569607|BG001|Baseline|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
11097558|NCT01569607|BG002|Baseline|Total|Total of all reporting groups
11097559|NCT01569607|FG000|Participant Flow|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
11097560|NCT01569607|FG001|Participant Flow|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
11097561|NCT01569607|OG000|Outcome|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
11097562|NCT01569607|OG001|Outcome|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
11097563|NCT01569607|EG000|Reported Event|Hebbian-type Stimulation|"Participants were randomized to receive motor training with Hebbian-type stimulation.~Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row"
11097564|NCT01569607|EG001|Reported Event|Sham Stimulation|"Participants were randomized to receive sham stimulation.~Sham stimulation: Sham stimulation"
11097565|NCT01569737|BG000|Baseline|Ella|ella: ella, single intake, tablet 30mg
11097566|NCT01569737|FG000|Participant Flow|Ella|ella: ella, single intake, tablet 30mg
11097567|NCT01569737|OG000|Outcome|Ella|ella: ella, single intake, tablet 30mg
11097568|NCT01569737|EG000|Reported Event|Ella|ella: ella, single intake, tablet 30mg
11097569|NCT01569763|BG000|Baseline|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system
11097570|NCT01569763|BG001|Baseline|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
11097571|NCT01569763|BG002|Baseline|Total|Total of all reporting groups
11097572|NCT01569763|FG000|Participant Flow|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
11097573|NCT01569763|FG001|Participant Flow|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
11097574|NCT01569763|OG000|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
11097575|NCT01569763|OG001|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
11097576|NCT01569763|EG000|Reported Event|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
11097577|NCT01569763|EG001|Reported Event|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
11097578|NCT01569815|BG000|Baseline|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
11097579|NCT01569815|BG001|Baseline|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097580|NCT01569815|BG002|Baseline|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
11097581|NCT01569815|BG003|Baseline|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097582|NCT01569815|BG004|Baseline|Total|Total of all reporting groups
11097583|NCT01569815|FG000|Participant Flow|Mild Renal Impaired|LCZ696 400 mg once daily for 5 days
11097584|NCT01569815|FG001|Participant Flow|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097585|NCT01569815|FG002|Participant Flow|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
11097586|NCT01569815|FG003|Participant Flow|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097587|NCT01569815|OG000|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
11097588|NCT01569815|OG001|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097589|NCT01569815|OG002|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
11097590|NCT01569815|OG003|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
11097591|NCT01569815|EG000|Reported Event|LCZ696 400 mg - Mild - Renal Impaired Patients|LCZ696 400 mg - Mild - Renal impaired patients
11097592|NCT01569815|EG001|Reported Event|LCZ696 400 mg - Mild - Matched Healthy Subjects|LCZ696 400 mg - Mild - Matched healthy subjects
11097593|NCT01569815|EG002|Reported Event|LCZ696 400 mg - Moderate - Renal Impaired Patients|LCZ696 400 mg - Moderate - Renal impaired patients
11097594|NCT01569815|EG003|Reported Event|LCZ696 400 mg - Moderate - Matched Healthy Subjects|LCZ696 400 mg - Moderate - Matched healthy subjects
11097595|NCT01569815|EG004|Reported Event|LCZ696 400 mg - All Healthy Subjects|LCZ696 400 mg - All healthy subjects
11097596|NCT01569828|BG000|Baseline|Severe Renal Impaired Subjects|"Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
11097597|NCT01569828|BG001|Baseline|Matched Healthy Volunteers|"All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
11097598|NCT01569828|BG002|Baseline|Total|Total of all reporting groups
11097599|NCT01569828|FG000|Participant Flow|Severe Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
11097600|NCT01569828|FG001|Participant Flow|Matched Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
11328437|NCT03427073|EG006|Reported Event|Cohort 7 - ALM201|Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
11328438|NCT03427073|EG007|Reported Event|Cohort 8 - ALM201|Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
11097601|NCT01569828|OG000|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
11097602|NCT01569828|OG001|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
11097603|NCT01569828|OG000|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days
11097604|NCT01569828|EG000|Reported Event|Severe Renal Impaired Patients|
11097605|NCT01569828|EG001|Reported Event|Matched Healthy Volunteers|
11097606|NCT01569841|BG000|Baseline|Full Analysis Set|The full analysis set (FAS) included all randomised subjects.
11097607|NCT01569841|FG000|Participant Flow|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
11097608|NCT01569841|FG001|Participant Flow|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
11097609|NCT01569841|OG000|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
11097610|NCT01569841|OG001|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
11097611|NCT01569841|OG000|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
11328439|NCT03427177|BG000|Baseline|Treatment|"Participants randomized to the treatment arm of the study will be given the mychoice tool.~mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools."
11097612|NCT01569841|OG001|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
11097613|NCT01569841|EG000|Reported Event|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
11097614|NCT01569841|EG001|Reported Event|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
11097615|NCT01570036|BG000|Baseline|Herceptin + NeuVax Vaccine|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.
11097616|NCT01570036|BG001|Baseline|Herceptin + GM-CSF Only|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.
11097617|NCT01570036|BG002|Baseline|Total|Total of all reporting groups
11097618|NCT01570036|FG000|Participant Flow|Herceptin + NeuVax Vaccine|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.
11097619|NCT01570036|FG001|Participant Flow|Herceptin + GM-CSF Only|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.
11097620|NCT01570036|OG000|Outcome|Herceptin + NeuVax Vaccine|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.
11097621|NCT01570036|OG001|Outcome|Herceptin + GM-CSF Only|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.
11097622|NCT01570036|EG000|Reported Event|Herceptin + NeuVax Vaccine|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.
11097623|NCT01570036|EG001|Reported Event|Herceptin + GM-CSF Only|Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.
11097624|NCT01570192|BG000|Baseline|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
11097625|NCT01570192|BG001|Baseline|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
11097626|NCT01570192|BG002|Baseline|Total|Total of all reporting groups
11097627|NCT01570192|FG000|Participant Flow|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
11097628|NCT01570192|FG001|Participant Flow|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
11328440|NCT03427177|BG001|Baseline|Control|Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
11328441|NCT03427177|BG002|Baseline|Total|Total of all reporting groups
11097629|NCT01570192|OG000|Outcome|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
11097630|NCT01570192|OG001|Outcome|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
11097631|NCT01570192|OG000|Outcome|ME Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
11097632|NCT01570192|OG001|Outcome|MEGroup - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
11097633|NCT01570192|OG002|Outcome|m-MITT Group - Meropenem Plus Aminoglycoside|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
11097634|NCT01570192|OG003|Outcome|m-MITT Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
11097635|NCT01570192|OG001|Outcome|ME Group - Meropenem Only|Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
11097636|NCT01570192|EG000|Reported Event|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
11097637|NCT01570192|EG001|Reported Event|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
11097638|NCT01570244|BG000|Baseline|All Subjects|The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
11097639|NCT01570244|FG000|Participant Flow|All Subjects|"The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.~Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.~Period 2: Microgynon tablets and Faldaprevir."
11097640|NCT01570244|OG000|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
11097641|NCT01570244|OG001|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
11097642|NCT01570244|EG000|Reported Event|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
11097643|NCT01570244|EG001|Reported Event|Microgynon + BI 201335|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
11097644|NCT01570283|BG000|Baseline|Multivirus-specific T Cells 5*10^6 mCTLs/m2|Cohort 1 (prophylaxis and treatment): Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097645|NCT01570283|BG001|Baseline|Multivirus-specific T Cells 1*10^7 mCTLs/m2|Cohort 2 (prophylaxis and treatment): Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097646|NCT01570283|BG002|Baseline|Multivirus-specific T Cells 2*10^7 mCTLs/m2|Cohort 3 (prophylaxis and treatment): Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097647|NCT01570283|BG003|Baseline|Total|Total of all reporting groups
11097648|NCT01570283|FG000|Participant Flow|Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Prophylaxis|Cohort 1 prophylaxis: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097649|NCT01570283|FG001|Participant Flow|Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment|Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097650|NCT01570283|FG002|Participant Flow|Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Prophylaxis|Cohort 2 prophylaxis: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097651|NCT01570283|FG003|Participant Flow|Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment|Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097652|NCT01570283|FG004|Participant Flow|Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis|Cohort 3 prophylaxis: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097653|NCT01570283|FG005|Participant Flow|Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment|Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097654|NCT01570283|OG000|Outcome|Multivirus-specific T Cells 5*10^6 mCTLs/m2|Cohort 1 (prophylaxis and treatment): Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097655|NCT01570283|OG001|Outcome|Multivirus-specific T Cells 1*10^7 mCTLs/m2|Cohort 2 (prophylaxis and treatment): Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097656|NCT01570283|OG002|Outcome|Multivirus-specific T Cells 2*10^7 mCTLs/m2|Cohort 3 (prophylaxis and treatment): Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097657|NCT01570283|OG000|Outcome|Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment|Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097658|NCT01570283|OG001|Outcome|Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment|Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097659|NCT01570283|OG002|Outcome|Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment|Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097660|NCT01570283|OG001|Outcome|Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment|Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097661|NCT01570283|OG002|Outcome|Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment|Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097662|NCT01570283|OG000|Outcome|Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment|Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097663|NCT01570283|EG000|Reported Event|Multivirus-specific T Cells 5*10^6 mCTLs/m2|Cohort 1 (prophylaxis and treatment): Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097664|NCT01570283|EG001|Reported Event|Multivirus-specific T Cells 1*10^7 mCTLs/m2|Cohort 2 (prophylaxis and treatment): Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097665|NCT01570283|EG002|Reported Event|Multivirus-specific T Cells 2*10^7 mCTLs/m2|Cohort 3 (prophylaxis and treatment): Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
11097666|NCT01570309|BG000|Baseline|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
11097667|NCT01570309|BG001|Baseline|Sugar Pill|Matching placebo
11097668|NCT01570309|BG002|Baseline|Total|Total of all reporting groups
11097669|NCT01570309|FG000|Participant Flow|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
11097670|NCT01570309|FG001|Participant Flow|Sugar Pill|Matching placebo
11097671|NCT01570309|OG000|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
11097672|NCT01570309|OG001|Outcome|Sugar Pill|Matching placebo
11097673|NCT01570309|OG000|Outcome|Active|Ergocalciferal 50,000 U qweekly x 12 weeks
11097674|NCT01570309|OG001|Outcome|Sugar Pill|Matching Placebo
11097675|NCT01570309|OG000|Outcome|Active Therapy|Ergocalciferol 50,000 U q weekly x 12 weeks
11097676|NCT01570309|OG001|Outcome|Placebo|Sugar Pill
10834235|NCT00160251|OG001|Outcome|Arm 1B: PEG + RBV + BOC 400|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834236|NCT00160251|OG002|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834237|NCT00160251|OG003|Outcome|Arm 3: PEG + BOC 200|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834238|NCT00160251|OG004|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834239|NCT00160251|OG005|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834240|NCT00160251|OG006|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834241|NCT00160251|OG007|Outcome|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
10834242|NCT00160251|OG000|Outcome|Log Drop 0 to <1|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834243|NCT00160251|OG001|Outcome|Log Drop 1 to <2|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834244|NCT00160251|OG002|Outcome|Log Drop 2 to <3|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834245|NCT00160251|OG003|Outcome|Log Drop 3 to <4|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834246|NCT00160251|OG004|Outcome|Log Drop 4 to <5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834247|NCT00160251|OG005|Outcome|Log Drop ≥5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
10834248|NCT00160251|OG000|Outcome|Log Drop 1 to <2|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
10834249|NCT00160251|OG001|Outcome|Log Drop 2 to <3|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
10834250|NCT00160251|OG002|Outcome|Log Drop 3 to <4|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
10834251|NCT00160251|OG003|Outcome|Log Drop 4 to <5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
10834252|NCT00160251|OG004|Outcome|Log Drop ≥5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
10834253|NCT00160251|OG000|Outcome|Log Drop <0|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834254|NCT00160251|OG001|Outcome|Log Drop 0 to <1|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834255|NCT00160251|OG002|Outcome|Log Drop 1 to <2|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834256|NCT00160251|OG003|Outcome|Log Drop 2 to <3|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
11097677|NCT01570309|EG000|Reported Event|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
11097678|NCT01570309|EG001|Reported Event|Sugar Pill|Matching placebo
11097679|NCT01570348|BG000|Baseline|Treatment (Allogeneic BMT)|"CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo donor BMT on day 0.~IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Mycophenolic Acid: Given PO~Quality-of-Life Assessment: Ancillary studies~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
11097680|NCT01570348|FG000|Participant Flow|Treatment (Allogeneic BMT)|"CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo donor BMT on day 0.~IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Mycophenolic Acid: Given PO~Quality-of-Life Assessment: Ancillary studies~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
11097681|NCT01570348|OG000|Outcome|Treatment (Allogeneic BMT)|"CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo donor BMT on day 0.~IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Mycophenolic Acid: Given PO~Quality-of-Life Assessment: Ancillary studies~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
11097682|NCT01570348|EG000|Reported Event|Treatment (Allogeneic BMT)|"CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo donor BMT on day 0.~IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT~Cyclophosphamide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Mycophenolic Acid: Given PO~Quality-of-Life Assessment: Ancillary studies~Tacrolimus: Given IV or PO~Total-Body Irradiation: Undergo TBI"
11097683|NCT01570361|BG000|Baseline|Radiofrequency (RF) Ablation Treatment|Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
11097684|NCT01570361|BG001|Baseline|Antiarrhythmic Drug (AAD) Therapy|Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
11097685|NCT01570361|BG002|Baseline|Total|Total of all reporting groups
11097686|NCT01570361|FG000|Participant Flow|Radiofrequency (RF) Ablation Treatment|Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
11097687|NCT01570361|FG001|Participant Flow|Antiarrhythmic Drug (AAD) Therapy|Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
11097688|NCT01570361|OG000|Outcome|Radiofrequency (RF) Ablation Treatment|Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
11097689|NCT01570361|OG001|Outcome|Antiarrhythmic Drug (AAD) Therapy|Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
11097690|NCT01570361|OG001|Outcome|Radiofrequency (RF) Ablation 2nd Treatment|Participants who were initially treated with AAD therapy (1st treatment) and then crossed over to RF ablation (2nd treatment) were evaluated. AAD therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
11097691|NCT01570361|EG000|Reported Event|Radiofrequency (RF) Ablation Treatment|Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
11097692|NCT01570361|EG001|Reported Event|Antiarrhythmic Drug (AAD) Therapy Only|Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. This group includes only those subjects received AAD only.
11097693|NCT01570361|EG002|Reported Event|Antiarrhythmic Drug (AAD) Therapy - First Treatment|This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the AAD treatment period.
11097694|NCT01570361|EG003|Reported Event|Radiofrequency (RF) Ablation - Second Treatment|This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the RF treatment period.
11097695|NCT01570387|BG000|Baseline|Phase I - Cohort 1 (Pomalidomide 2mg) Plus Dexam|"Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28~Dexamethasone: 10-20 mg on days 1, 8, 15, and 22"
11097696|NCT01570387|BG001|Baseline|Phase I - Cohort 2 (Pomalidomide 3mg)|Pomalidomide 3 mg/day on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
11097697|NCT01570387|BG002|Baseline|Phase I - Cohort 3 (Pomalidomide 4mg)|Pomalidomide 4 mg/day on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
11097698|NCT01570387|BG003|Baseline|Phase II Expansion- (Pomalidomide 4mg) Plus Dexa|Pomalidomide 4 mg/day (MTD) on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
11097699|NCT01570387|BG004|Baseline|Total|Total of all reporting groups
11097700|NCT01570387|FG000|Participant Flow|Experimental: Phase I - Cohort 1 (Pomalidomide 2mg)|"Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097701|NCT01570387|FG001|Participant Flow|Experimental: Phase I - Cohort 2 (Pomalidomide 3mg)|"Drug: Pomalidomide Cohort 12= 3 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097702|NCT01570387|FG002|Participant Flow|Experimental: Phase I - Cohort 3 (Pomalidomide 4mg)|"Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097703|NCT01570387|FG003|Participant Flow|Experimental: Phase II Expansion- Maximum Tolerated Dose|"Drug: Pomalidomide Expansion Phase - Maximum Tolerated Dose = 4 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097704|NCT01570387|OG000|Outcome|Pom Plus Dex|"Pomalidomide dexamethasone~Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28~Dexamethasone: 10-20 mg on days 1, 8, 15, and 22"
11097705|NCT01570387|EG000|Reported Event|Phase I - Cohort 1 (Pomalidomide 2mg)|"Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097706|NCT01570387|EG001|Reported Event|Phase I - Cohort 2 (Pomalidomide 3mg)|"Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097707|NCT01570387|EG002|Reported Event|Phase I - Cohort 3 (Pomalidomide 4mg)|"Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097708|NCT01570387|EG003|Reported Event|Phase II Expansion- Maximum Tolerated Dose|"Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28~Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22"
11097709|NCT01570491|BG000|Baseline|Ultrasound-guided Spinal Anesthesia|"Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.~ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block."
11097710|NCT01570491|BG001|Baseline|Standard Spinal Anesthesia|"Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.~standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block."
11097711|NCT01570491|BG002|Baseline|Total|Total of all reporting groups
11097712|NCT01570491|FG000|Participant Flow|Ultrasound-guided Spinal Anesthesia|"Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.~ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block."
11097713|NCT01570491|FG001|Participant Flow|Standard Spinal Anesthesia|"Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.~standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block."
11097714|NCT01570491|OG000|Outcome|Ultrasound-guided Spinal Anesthesia|"Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.~ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block."
11097715|NCT01570491|OG001|Outcome|Standard Spinal Anesthesia|"Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.~standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block."
11097716|NCT01570491|EG000|Reported Event|Ultrasound-guided Spinal Anesthesia|"Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.~ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block."
11097717|NCT01570491|EG001|Reported Event|Standard Spinal Anesthesia|"Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.~standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block."
11097718|NCT01570686|BG000|Baseline|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
11097719|NCT01570686|BG001|Baseline|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
11097720|NCT01570686|BG002|Baseline|Total|Total of all reporting groups
11097721|NCT01570686|FG000|Participant Flow|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
11097722|NCT01570686|FG001|Participant Flow|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
11097723|NCT01570686|OG000|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
11097724|NCT01570686|OG001|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
11097725|NCT01570686|EG000|Reported Event|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
11097726|NCT01570686|EG001|Reported Event|Aliskiren 300 mg (Fasted)|Aliskiren 300 mg once daily taken after after an overnight fast
11097727|NCT01570751|BG000|Baseline|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097728|NCT01570751|BG001|Baseline|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097729|NCT01570751|BG002|Baseline|Total|Total of all reporting groups
11097730|NCT01570751|FG000|Participant Flow|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097731|NCT01570751|FG001|Participant Flow|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097732|NCT01570751|OG000|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
11097733|NCT01570751|OG001|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
11097734|NCT01570751|OG000|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097735|NCT01570751|OG001|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
11097736|NCT01570751|EG000|Reported Event|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
11097737|NCT01570751|EG001|Reported Event|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
11097738|NCT01570829|BG000|Baseline|Dietressa|"Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.~Dietressa: Oral administration."
11097739|NCT01570829|BG001|Baseline|Placebo|"Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.~Placebo: Oral administration."
11097740|NCT01570829|BG002|Baseline|Total|Total of all reporting groups
11097741|NCT01570829|FG000|Participant Flow|Dietressa|"Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.~Dietressa: Oral administration."
11097742|NCT01570829|FG001|Participant Flow|Placebo|"Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.~Placebo: Oral administration."
11097743|NCT01570829|OG000|Outcome|Dietressa|"Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.~Dietressa: Oral administration."
11097744|NCT01570829|OG001|Outcome|Placebo|"Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.~Placebo: Oral administration."
11097745|NCT01570829|EG000|Reported Event|Dietressa|"Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.~Dietressa: Oral administration."
11097746|NCT01570829|EG001|Reported Event|Placebo|"Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.~Placebo: Oral administration."
11097747|NCT01570868|BG000|Baseline|Ponatinib 45 mg|Ponatinib 45 mg orally, once daily.
11097748|NCT01570868|BG001|Baseline|Ponatinib 30 mg|Ponatinib 30 mg orally, once daily.
11097749|NCT01570868|BG002|Baseline|Total|Total of all reporting groups
11097750|NCT01570868|FG000|Participant Flow|Ponatinib 45 mg|Ponatinib 45 mg orally, once daily.
11097751|NCT01570868|FG001|Participant Flow|Ponatinib 30 mg|Ponatinib 30 mg orally, once daily.
11097752|NCT01570868|OG000|Outcome|Ponatinib 45 mg|Ponatinib 45 mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
11097753|NCT01570868|OG001|Outcome|Ponatinib 30 mg|Ponatinib 30mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
11097754|NCT01570868|OG000|Outcome|Ponatinib 45 mg|Ponatinib 45 mg orally, once daily.
11097755|NCT01570868|OG001|Outcome|Ponatinib 30 mg|Ponatinib 30 mg orally, once daily.
11097756|NCT01570868|OG000|Outcome|Ponatinib 45 mg|Ponatinib oral dose 45 mg daily.
11097757|NCT01570868|OG001|Outcome|Ponatinib 30 mg|Ponatinib oral dose 30 mg daily.
11097758|NCT01570868|EG000|Reported Event|Ponatinib 45 mg|Ponatinib 45 mg orally, once daily.
11097759|NCT01570868|EG001|Reported Event|Ponatinib 30 mg|Ponatinib 30 mg orally, once daily.
11097760|NCT01571232|BG000|Baseline|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
11097761|NCT01571232|BG001|Baseline|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
11097762|NCT01571232|BG002|Baseline|Total|Total of all reporting groups
11097763|NCT01571232|FG000|Participant Flow|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
11097764|NCT01571232|FG001|Participant Flow|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
11097765|NCT01571232|OG000|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
11097766|NCT01571232|OG001|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
11097767|NCT01571232|OG000|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant:~Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
11097768|NCT01571232|EG000|Reported Event|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
11097769|NCT01571232|EG001|Reported Event|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
11097770|NCT01571284|BG000|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11097771|NCT01571284|FG000|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11097772|NCT01571284|OG000|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11097773|NCT01571284|EG000|Reported Event|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
11097774|NCT01571362|BG000|Baseline|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
11097775|NCT01571362|FG000|Participant Flow|Open ALO-02|Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
11097776|NCT01571362|FG001|Participant Flow|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
11097777|NCT01571362|FG002|Participant Flow|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
11097778|NCT01571362|OG000|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
11328442|NCT03427177|FG000|Participant Flow|Treatment|"Participants randomized to the treatment arm of the study will be given the mychoice tool.~mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools."
11097779|NCT01571362|OG001|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
11097780|NCT01571362|OG000|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
11097781|NCT01571362|EG000|Reported Event|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
11097782|NCT01571362|EG001|Reported Event|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
11097783|NCT01571362|EG002|Reported Event|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
11097784|NCT01571427|BG000|Baseline|Active Soocial Engagement Group|"Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks~Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention"
11097785|NCT01571427|BG001|Baseline|Control Group|"No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.~Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device"
11097786|NCT01571427|BG002|Baseline|Total|Total of all reporting groups
11097787|NCT01571427|FG000|Participant Flow|Active Social Engagement Group|"Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks~Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention"
11097788|NCT01571427|FG001|Participant Flow|Control Group|"No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.~Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device"
11097789|NCT01571427|OG000|Outcome|Active Social Engagement Group|"Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks~Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention"
11097790|NCT01571427|OG001|Outcome|Control Group|"No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.~Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device"
11097791|NCT01571427|EG000|Reported Event|Control Group|"no daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.~Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device"
11097792|NCT01571427|EG001|Reported Event|Active Soocial Engagement Group|"Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks~Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention"
11097793|NCT01571453|BG000|Baseline|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
11097794|NCT01571453|BG001|Baseline|Venlafaxine|Venlafaxine extended release: 150 mg/day
11097795|NCT01571453|BG002|Baseline|Total|Total of all reporting groups
11097796|NCT01571453|FG000|Participant Flow|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
11097797|NCT01571453|FG001|Participant Flow|Venlafaxine|Venlafaxine extended release 150 mg/day
11097798|NCT01571453|OG000|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
11097799|NCT01571453|OG001|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
11097800|NCT01571453|EG000|Reported Event|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
11097801|NCT01571453|EG001|Reported Event|Venlafaxine|Venlafaxine extended release: 150 mg/day
11097802|NCT01571557|BG000|Baseline|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
11097803|NCT01571557|FG000|Participant Flow|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
11097804|NCT01571557|OG000|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
11097805|NCT01571557|EG000|Reported Event|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
11097806|NCT01571596|BG000|Baseline|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor."
11097807|NCT01571596|BG001|Baseline|Bone Substudy KRN23|
11097808|NCT01571596|BG002|Baseline|Bone Substudy Placebo|
11097809|NCT01571596|BG003|Baseline|Total|Total of all reporting groups
11097810|NCT01571596|FG000|Participant Flow|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor."
11097811|NCT01571596|FG001|Participant Flow|Bone Substudy KRN23|A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
11097812|NCT01571596|FG002|Participant Flow|Bone Substudy Placebo|A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33.
11097813|NCT01571596|OG000|Outcome|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor."
11097814|NCT01571596|OG001|Outcome|Bone Substudy KRN23|
11097815|NCT01571596|OG002|Outcome|Bone Substudy Placebo|
11097816|NCT01571596|OG000|Outcome|Bone Substudy KRN23|
11097817|NCT01571596|OG001|Outcome|Bone Substudy Placebo|
11097818|NCT01571596|EG000|Reported Event|KRN23|"Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)~KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor."
11097819|NCT01571596|EG001|Reported Event|Bone Substudy KRN23|
11097820|NCT01571596|EG002|Reported Event|Bone Substudy Placebo|
11097821|NCT01572038|BG000|Baseline|Pertuzumab + Trastuzumab + Taxane|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097822|NCT01572038|FG000|Participant Flow|Pertuzumab + Trastuzumab + Taxane|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097823|NCT01572038|OG000|Outcome|Pertuzumab + Trastuzumab + Taxane|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097824|NCT01572038|OG000|Outcome|Europe|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097825|NCT01572038|OG001|Outcome|Asia|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097826|NCT01572038|OG002|Outcome|North America|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097827|NCT01572038|OG003|Outcome|South America|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097828|NCT01572038|OG004|Outcome|Africa|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097829|NCT01572038|OG005|Outcome|Other (Australia)|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097830|NCT01572038|OG000|Outcome|Age ≤65 Years|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097831|NCT01572038|OG001|Outcome|Age >65 Years|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097832|NCT01572038|OG000|Outcome|Docetaxel|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Participants in this subgroup received docetaxel as their taxane chemotherapy, per the investigator's choice.
11097833|NCT01572038|OG001|Outcome|Paclitaxel|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Participants in this subgroup received paclitaxel as their taxane chemotherapy, per the investigator's choice.
11097834|NCT01572038|OG002|Outcome|Nab-Paclitaxel|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Participants in this subgroup received nab-paclitaxel as their taxane chemotherapy, per the investigator's choice.
11097835|NCT01572038|OG000|Outcome|ECOG Performance Status 0 or 1|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097836|NCT01572038|OG001|Outcome|ECOG Performance Status 2|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097837|NCT01572038|OG000|Outcome|Visceral Disease|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097838|NCT01572038|OG001|Outcome|Non-Visceral Disease|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097839|NCT01572038|OG000|Outcome|Prior (Neo)Adjuvant Chemotherapy|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097840|NCT01572038|OG001|Outcome|No Prior (Neo)Adjuvant Chemotherapy|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097841|NCT01572038|OG000|Outcome|Hormone Receptor Positive|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097842|NCT01572038|OG001|Outcome|Hormone Receptor Negative|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097843|NCT01572038|OG002|Outcome|Hormone Receptor Status Unknown|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097844|NCT01572038|OG000|Outcome|Previous Trastuzumab Therapy|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097845|NCT01572038|OG001|Outcome|No Previous Trastuzumab Therapy|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097846|NCT01572038|EG000|Reported Event|Pertuzumab + Trastuzumab + Taxane|Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.
11097847|NCT01572298|BG000|Baseline|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
10834257|NCT00160251|OG004|Outcome|Log Drop 3 to <4|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834258|NCT00160251|OG005|Outcome|Log Drop 4 to <5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834259|NCT00160251|OG006|Outcome|Log Drop ≥5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834260|NCT00160251|OG007|Outcome|Missing Data|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
10834261|NCT00160251|EG000|Reported Event|PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
10834262|NCT00160251|EG001|Reported Event|PEG + RBV + BOC 400 (24 Weeks)|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834263|NCT00160251|EG002|Reported Event|PEG + BOC 100 (48 Weeks)|Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834264|NCT00160251|EG003|Reported Event|PEG + BOC 200 (48 Weeks)|Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834265|NCT00160251|EG004|Reported Event|PEG + RBV + BOC 400 (48 Weeks)|Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834266|NCT00160251|EG005|Reported Event|PEG + BOC 400 (24 + 48 Weeks)|Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834267|NCT00160251|EG006|Reported Event|PEG + BOC 800 (24 Weeks)|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
10834268|NCT00160251|EG007|Reported Event|PEG + RBV + BOC 800|Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
10834269|NCT00160524|BG000|Baseline|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
10834270|NCT00160524|FG000|Participant Flow|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
10834271|NCT00160524|OG000|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
10834272|NCT00160524|EG000|Reported Event|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
10834273|NCT00160615|BG000|Baseline|N165 Randomized Treatment PBO (FAS)|Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834274|NCT00160615|BG001|Baseline|N165 Randomized Treatment LEV (FAS)|Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834275|NCT00160615|BG002|Baseline|Total Title|
10834276|NCT00160615|FG000|Participant Flow|N165 Randomized Treatment PBO|Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834277|NCT00160615|FG001|Participant Flow|N165 Randomized Treatment LEV|Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834278|NCT00160615|OG000|Outcome|N165 Randomized Treatment PBO|Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834279|NCT00160615|OG001|Outcome|N165 Randomized Treatment LEV|Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834280|NCT00160615|OG000|Outcome|N165 Randomized Treatment PBO (FAS)|Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834281|NCT00160615|OG001|Outcome|N165 Randomized Treatment LEV (FAS)|Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834282|NCT00160615|EG000|Reported Event|N165 Randomized Treatment PBO (FAS)|Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. In the Placebo group the Serious Adverse Events (SAEs) Status epilepticus and Agitation occurred twice in 2 subjects.
10834283|NCT00160615|EG001|Reported Event|N165 Randomized Treatment LEV (FAS)|Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
10834284|NCT00160641|BG000|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10834285|NCT00160641|FG000|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10834286|NCT00160641|OG000|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10834287|NCT00160641|EG000|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10834288|NCT00160654|BG000|Baseline|Levetiracetam|Subjects received open-label Levetiracetam.
10834289|NCT00160654|FG000|Participant Flow|Levetiracetam|Subjects received open-label Levetiracetam.
10834290|NCT00160654|OG000|Outcome|Levetiracetam|Subjects received open-label Levetiracetam.
10834291|NCT00160654|EG000|Reported Event|Levetiracetam|Subjects received open-label Levetiracetam.
10834292|NCT00160667|BG000|Baseline|Placebo|Matching placebo tablets administered twice a day.
10834293|NCT00160667|BG001|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 200 mg/day (100 mg administered twice a day).
10834294|NCT00160667|BG002|Baseline|Brivaracetam 400 mg/Day|Brivaracetam 400 mg/day (200 mg administered twice a day).
10834295|NCT00160667|BG003|Baseline|Total Title|
10834296|NCT00160667|FG000|Participant Flow|Placebo|Matching placebo tablets administered twice a day.
10834297|NCT00160667|FG001|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 200 mg/day (100 mg administered twice a day).
10834298|NCT00160667|FG002|Participant Flow|Brivaracetam 400 mg/Day|Brivaracetam 400 mg/day (200 mg administered twice a day).
10834299|NCT00160667|OG000|Outcome|Placebo|Matching placebo tablets administered twice a day.
10834300|NCT00160667|OG001|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 200 mg/day (100 mg administered twice a day).
10834301|NCT00160667|OG002|Outcome|Brivaracetam 400 mg/Day|Brivaracetam 400 mg/day (200 mg administered twice a day).
10834302|NCT00160667|OG000|Outcome|Placebo|Matching Placebo tablets administered twice a day.
10834303|NCT00160667|EG000|Reported Event|Placebo|Matching placebo tablets administered twice a day.
10834304|NCT00160667|EG001|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 200 mg/day (100 mg administered twice a day).
10834305|NCT00160667|EG002|Reported Event|Brivaracetam 400 mg/Day|Brivaracetam 400 mg/day (200 mg administered twice a day).
10834306|NCT00160680|BG000|Baseline|Continuous Treatment (CT)|5 mg of Levocetirizine (LCTZ) was taken orally once a day.
10834307|NCT00160680|BG001|Baseline|On Demand Treatment (ODT)|5 mg of Levocetirizine (LCTZ) was taken whenever needed.
10834308|NCT00160680|BG002|Baseline|Total Title|
10834309|NCT00160680|FG000|Participant Flow|Continuous Treatment (CT)|5 mg of Levocetirizine (LCTZ) was taken orally once a day.
10834310|NCT00160680|FG001|Participant Flow|On Demand Treatment (ODT)|5 mg of Levocetirizine (LCTZ) was taken whenever needed.
10834311|NCT00160680|OG000|Outcome|Continuous Treatment (CT)|5 mg of Levocetirizine (LCTZ) was taken orally once a day.
10834312|NCT00160680|OG001|Outcome|On Demand Treatment (ODT)|5 mg of Levocetirizine (LCTZ) was taken whenever needed.
10834313|NCT00160680|EG000|Reported Event|Continuous Treatment (SS)|5 mg of Levocetirizine (LCTZ) was taken orally once a day.
10834314|NCT00160680|EG001|Reported Event|On Demand Treatment (SS)|5 mg of Levocetirizine (LCTZ) was taken whenever needed.
10834315|NCT00160693|BG000|Baseline|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
10834316|NCT00160693|FG000|Participant Flow|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
10834317|NCT00160693|OG000|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
11097848|NCT01572298|BG001|Baseline|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097849|NCT01572298|BG002|Baseline|Total|Total of all reporting groups
11097850|NCT01572298|FG000|Participant Flow|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097851|NCT01572298|FG001|Participant Flow|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097852|NCT01572298|OG000|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097853|NCT01572298|OG001|Outcome|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097854|NCT01572298|OG000|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone: use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097855|NCT01572298|OG001|Outcome|Allograft With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft with autograft: use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097856|NCT01572298|EG000|Reported Event|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097857|NCT01572298|EG001|Reported Event|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
11097858|NCT01572389|BG000|Baseline|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
11097859|NCT01572389|BG001|Baseline|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
11097860|NCT01572389|BG002|Baseline|Total|Total of all reporting groups
11097861|NCT01572389|FG000|Participant Flow|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
11097862|NCT01572389|FG001|Participant Flow|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
11097863|NCT01572389|OG000|Outcome|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
11097864|NCT01572389|OG001|Outcome|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
10834318|NCT00160693|EG000|Reported Event|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
11097865|NCT01572389|EG000|Reported Event|Arm 1: HOPE|"The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.~Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period."
11097866|NCT01572389|EG001|Reported Event|Arm 2: EUC|"The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.~Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care."
11097867|NCT01572428|BG000|Baseline|Narrow-Band Imaging (NBI)|"Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)~Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy."
11097868|NCT01572428|BG001|Baseline|Standard White Light|"Inspection with Standard White Light versus Narrow-Band Imaging(NBI)~Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy."
11097869|NCT01572428|BG002|Baseline|Total|Total of all reporting groups
11097870|NCT01572428|FG000|Participant Flow|Narrow-Band Imaging (NBI)|"Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)~Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy."
11097871|NCT01572428|FG001|Participant Flow|Standard White Light|"Inspection with Standard White Light versus Narrow-Band Imaging(NBI)~Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy."
11097872|NCT01572428|OG000|Outcome|Narrow-Band Imaging (NBI)|"Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)~Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy."
11097873|NCT01572428|OG001|Outcome|Standard White Light|"Inspection with Standard White Light versus Narrow-Band Imaging(NBI)~Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy."
11097874|NCT01572428|EG000|Reported Event|Narrow-Band Imaging (NBI)|"Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)~Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy."
11097875|NCT01572428|EG001|Reported Event|Standard White Light|"Inspection with Standard White Light versus Narrow-Band Imaging(NBI)~Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy."
11097876|NCT01572727|BG000|Baseline|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
11097877|NCT01572727|BG001|Baseline|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
11097878|NCT01572727|BG002|Baseline|Total|Total of all reporting groups
11097879|NCT01572727|FG000|Participant Flow|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
11097880|NCT01572727|FG001|Participant Flow|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
11097881|NCT01572727|OG000|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
11097882|NCT01572727|OG001|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
11097883|NCT01572727|EG000|Reported Event|Buparlisib (BKM120) 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
11097884|NCT01572727|EG001|Reported Event|Placebo 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
11097885|NCT01572740|BG000|Baseline|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097886|NCT01572740|BG001|Baseline|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097887|NCT01572740|BG002|Baseline|Total|Total of all reporting groups
11328443|NCT03427177|FG001|Participant Flow|Control|Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
11097888|NCT01572740|FG000|Participant Flow|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097889|NCT01572740|FG001|Participant Flow|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097890|NCT01572740|OG000|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097891|NCT01572740|OG001|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097892|NCT01572740|EG000|Reported Event|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097893|NCT01572740|EG001|Reported Event|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
11097894|NCT01572792|BG000|Baseline|Placebo|Placebo administered BID by inhalation
11097895|NCT01572792|BG001|Baseline|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
11097896|NCT01572792|BG002|Baseline|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
11328444|NCT03427177|OG000|Outcome|Treatment|"Participants randomized to the treatment arm of the study will be given the mychoice tool.~mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools."
11328445|NCT03427177|OG001|Outcome|Control|Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
11328446|NCT03427177|EG000|Reported Event|Treatment|"Participants randomized to the treatment arm of the study will be given the mychoice tool.~mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools."
10834319|NCT00160706|BG000|Baseline|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
11097897|NCT01572792|BG003|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
11097898|NCT01572792|BG004|Baseline|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
11097899|NCT01572792|BG005|Baseline|Total|Total of all reporting groups
11328447|NCT03427177|EG001|Reported Event|Control|Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
11328448|NCT03427268|BG000|Baseline|PM060184|PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
11097900|NCT01572792|FG000|Participant Flow|Placebo|Placebo administered BID by inhalation
11097901|NCT01572792|FG001|Participant Flow|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
11097902|NCT01572792|FG002|Participant Flow|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
11097903|NCT01572792|FG003|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
11097904|NCT01572792|FG004|Participant Flow|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
11097905|NCT01572792|OG000|Outcome|Placebo|Placebo administered BID by inhalation
11097906|NCT01572792|OG001|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
11097907|NCT01572792|OG002|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
11097908|NCT01572792|OG003|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
11097909|NCT01572792|OG004|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
11097910|NCT01572792|OG001|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
11097911|NCT01572792|EG000|Reported Event|Placebo|Placebo administered BID by inhalation
11097912|NCT01572792|EG001|Reported Event|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
11097913|NCT01572792|EG002|Reported Event|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
11097914|NCT01572792|EG003|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
11097915|NCT01572792|EG004|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
11097916|NCT01572844|BG000|Baseline|All Study Participants|This Arm includes all participants who were enrolled in the study
11097917|NCT01572844|FG000|Participant Flow|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
11097918|NCT01572844|FG001|Participant Flow|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
11097919|NCT01572844|OG000|Outcome|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
11097920|NCT01572844|OG001|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
11097921|NCT01572844|OG000|Outcome|Treatment Lesion|Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser
11097922|NCT01572844|OG000|Outcome|Treatment Lesion|Lesion A, target lesion
11097923|NCT01572844|OG001|Outcome|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment
11097924|NCT01572844|EG000|Reported Event|Treatment Lesion|"Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period."
11097925|NCT01572844|EG001|Reported Event|No Treatment Lesion|Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
11097926|NCT01572909|BG000|Baseline|Bendavia™|Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097927|NCT01572909|BG001|Baseline|Placebo|Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097928|NCT01572909|BG002|Baseline|Total|Total of all reporting groups
11097929|NCT01572909|FG000|Participant Flow|Bendavia™|Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097930|NCT01572909|FG001|Participant Flow|Placebo|Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097931|NCT01572909|OG000|Outcome|Bendavia™|Bendavia (MTP-131): 0.05 mg/kg/hr
11097932|NCT01572909|OG001|Outcome|Placebo|Placebo: Identically appearing placebo
11097933|NCT01572909|OG000|Outcome|Bendavia™|Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097934|NCT01572909|OG001|Outcome|Placebo|Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097935|NCT01572909|EG000|Reported Event|Bendavia™|Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097936|NCT01572909|EG001|Reported Event|Placebo|Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
11097937|NCT01572922|BG000|Baseline|Arm 1|All eligible patients with history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment
11097938|NCT01572922|FG000|Participant Flow|Arm 1|All eligible patients with history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment.
11097939|NCT01572922|OG000|Outcome|Iron-overloaded Patients|Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement
11097940|NCT01572922|OG000|Outcome|Iron-overloaded Patients|Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.
11097941|NCT01572922|OG000|Outcome|Iron-overloaded Patients|Iron-overloaded patients defined as having more than 12 transfusions in their lifetime as measured with R2* using 1.5T GRE.
11097942|NCT01572922|OG000|Outcome|Iron-overloaded Patients|Iron-overloaded patients with R2* using 1.5T UTE
11097943|NCT01572922|OG000|Outcome|Serum Iron Measurements|Serum iron measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
11097944|NCT01572922|OG000|Outcome|Iron-overloaded Patients|Iron-overloaded patients with 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
11097945|NCT01572922|EG000|Reported Event|Iron-overloaded Patients|Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement
11097946|NCT01572948|BG000|Baseline|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
11097947|NCT01572948|BG001|Baseline|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
11097948|NCT01572948|BG002|Baseline|Total|Total of all reporting groups
11097949|NCT01572948|FG000|Participant Flow|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
11097950|NCT01572948|FG001|Participant Flow|Placebo|500microgram white tablet
11097951|NCT01572948|OG000|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
11097952|NCT01572948|OG001|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
11097953|NCT01572948|OG000|Outcome|Placebo|"The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.~placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient"
11097954|NCT01572948|OG001|Outcome|Daliresp|"The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models~roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models"
11097955|NCT01572948|OG000|Outcome|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
11097956|NCT01572948|OG001|Outcome|Placebo|500microgram white tablet
11097957|NCT01572948|EG000|Reported Event|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
11097958|NCT01572948|EG001|Reported Event|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
11097959|NCT01573000|BG000|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097960|NCT01573000|BG001|Baseline|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097961|NCT01573000|BG002|Baseline|Total|Total of all reporting groups
11097962|NCT01573000|FG000|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097963|NCT01573000|FG001|Participant Flow|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097964|NCT01573000|OG000|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097965|NCT01573000|OG001|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097966|NCT01573000|OG000|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097967|NCT01573000|OG001|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097968|NCT01573000|OG002|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097969|NCT01573000|EG000|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097970|NCT01573000|EG001|Reported Event|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097971|NCT01573000|EG002|Reported Event|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
11097972|NCT01573052|BG000|Baseline|Chlordiazepoxide|25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c
11097973|NCT01573052|BG001|Baseline|Gabapentin|300mg qid x 3 days, 300mg tid x 1 day, 300mg bid x 1 day, 300mg hs x 1 day then d/c
11097974|NCT01573052|BG002|Baseline|Total|Total of all reporting groups
11097975|NCT01573052|FG000|Participant Flow|Chlordiazepoxide|25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue
11097976|NCT01573052|FG001|Participant Flow|Gabapentin|300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
10834320|NCT00160706|FG000|Participant Flow|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
10834321|NCT00160706|OG000|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
10834322|NCT00160706|EG000|Reported Event|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
10834323|NCT00161213|BG000|Baseline|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
10834324|NCT00161213|FG000|Participant Flow|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
10834325|NCT00161213|OG000|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
10834326|NCT00161213|EG000|Reported Event|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
10834327|NCT00161382|BG000|Baseline|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
10834328|NCT00161382|BG001|Baseline|Control Group|No intervention: Control curriculum consists of standard sexual education.
10834329|NCT00161382|BG002|Baseline|Total|Total of all reporting groups
10834330|NCT00161382|FG000|Participant Flow|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
10834331|NCT00161382|FG001|Participant Flow|Control Group|No intervention: Control curriculum consists of standard sexual education.
10834332|NCT00161382|OG000|Outcome|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
10834333|NCT00161382|OG001|Outcome|Control Group|No intervention: Control curriculum consists of standard sexual education.
10834334|NCT00161382|EG000|Reported Event|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
10834335|NCT00161382|EG001|Reported Event|Control Group|No intervention: Control curriculum consists of standard sexual education.
10834336|NCT00161473|BG000|Baseline|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
10834337|NCT00161473|BG001|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10834338|NCT00161473|BG002|Baseline|Total|Total of all reporting groups
10834339|NCT00161473|FG000|Participant Flow|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
10834340|NCT00161473|FG001|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10834341|NCT00161473|OG000|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
10834342|NCT00161473|OG001|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10834343|NCT00161473|EG000|Reported Event|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
10834344|NCT00161473|EG001|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10834345|NCT00161616|BG000|Baseline|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
10834346|NCT00161616|BG001|Baseline|Standard of Care|Standard of Care: Surgical fixation only
10834347|NCT00161616|BG002|Baseline|Total|Total of all reporting groups
10834348|NCT00161616|FG000|Participant Flow|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
10834349|NCT00161616|FG001|Participant Flow|Standard of Care|Standard of Care: Surgical fixation only
10834350|NCT00161616|OG000|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
10834351|NCT00161616|OG001|Outcome|Standard of Care|Standard of Care: Surgical fixation only
10834352|NCT00161616|EG000|Reported Event|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
10834353|NCT00161616|EG001|Reported Event|Standard of Care|Standard of Care: Surgical fixation only
10834354|NCT00162032|BG000|Baseline|Children (Ages 4-11)|Arm A children 4-11 years of age
10834355|NCT00162032|BG001|Baseline|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
10834356|NCT00162032|BG002|Baseline|Total|Total of all reporting groups
10834357|NCT00162032|FG000|Participant Flow|Children (Ages 4-11)|Arm A children 4-11 years of age
10834358|NCT00162032|FG001|Participant Flow|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
10834359|NCT00162032|OG000|Outcome|Children (4 -11 Years) Normal|SSS (summed stress score) <=4, low risk
10834360|NCT00162032|OG001|Outcome|Adolescents (12-16 Years) Normal|SSS (summed stress score) <4, low risk
10834361|NCT00162032|OG002|Outcome|Children (4-11 Years) Abnormal|SSS (summed stress score)>4, high risk
10834362|NCT00162032|OG003|Outcome|Adolescents (12-16 Years) Abnormal|sss (summed stress score >4, high risk
10834363|NCT00162032|OG000|Outcome|Angiography Subjects|Subset of pooled adolescent and child subjects who underwent coronary angiography
10834364|NCT00162032|OG000|Outcome|Children (Ages 4-11)|Arm A children 4-11 years of age who underwent coronary angiography
10834365|NCT00162032|OG001|Outcome|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age who underwent coronary angiography
10834366|NCT00162032|EG000|Reported Event|Children (Ages 4-11)|Arm A children 4-11 years of age
10834367|NCT00162032|EG001|Reported Event|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age
10834368|NCT00162097|BG000|Baseline|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
10834369|NCT00162097|BG001|Baseline|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
10834370|NCT00162097|BG002|Baseline|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
10834371|NCT00162097|BG003|Baseline|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
10834372|NCT00162097|BG004|Baseline|Total|Total of all reporting groups
10834373|NCT00162097|FG000|Participant Flow|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
11097977|NCT01573052|OG000|Outcome|Chlordiazepoxide|25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue
11097978|NCT01573052|OG001|Outcome|Gabapentin|300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
11097979|NCT01573052|OG001|Outcome|Gabapentin|300mg four times a day x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
11097980|NCT01573052|EG000|Reported Event|Chlordiazepoxide|25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c
11097981|NCT01573052|EG001|Reported Event|Gabapentin|300mg qid x 3 days, 300mg tid x 1 day, 300mg bid x 1 day, 300mg hs x 1 day then d/c
11097982|NCT01573169|BG000|Baseline|Low Weight Molecular Heparin|"enoxaparin 0.4 ml subcutaneous per day~Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke"
11097983|NCT01573169|BG001|Baseline|Standard Therapy|"Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization~Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy"
11097984|NCT01573169|BG002|Baseline|Total|Total of all reporting groups
11097985|NCT01573169|FG000|Participant Flow|Low Weight Molecular Heparin|"enoxaparin 0.4 ml subcutaneous per day~Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke"
11097986|NCT01573169|FG001|Participant Flow|Standard Therapy|"Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization~Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy"
11097987|NCT01573169|OG000|Outcome|Low Weight Molecular Heparin|"enoxaparin 0.4 ml subcutaneous per day~Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke"
11097988|NCT01573169|OG001|Outcome|Standard Therapy|"Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization~Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy"
11097989|NCT01573169|EG000|Reported Event|Low Weight Molecular Heparin|"enoxaparin 0.4 ml subcutaneous per day~Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke"
11097990|NCT01573169|EG001|Reported Event|Standard Therapy|"Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization~Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy"
11097991|NCT01573260|BG000|Baseline|Control|
11097992|NCT01573260|BG001|Baseline|Tango|
11097993|NCT01573260|BG002|Baseline|Total|Total of all reporting groups
11097994|NCT01573260|FG000|Participant Flow|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
11097995|NCT01573260|FG001|Participant Flow|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
11097996|NCT01573260|OG000|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
11097997|NCT01573260|OG001|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
11097998|NCT01573260|OG000|Outcome|Argentinean Tango|"A biweekly class of argentinean tango for a period of 3-months the intervention for this arm~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
11097999|NCT01573260|OG001|Outcome|A 'Wait-list' Control Group|"Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
11098000|NCT01573260|EG000|Reported Event|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
11098001|NCT01573260|EG001|Reported Event|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
11098002|NCT01573273|BG000|Baseline|Cocaine- Dependent Women Oxytocin|Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
11098003|NCT01573273|BG001|Baseline|Cocaine- Dependent Men Oxytocin|Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
11098004|NCT01573273|BG002|Baseline|Cocaine- Dependent Women Placebo|Cocaine-dependent women received Placebo prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
11098005|NCT01573273|BG003|Baseline|Cocaine -Dependent Men Placebo|Cocaine-dependent men received Placebo prior to completing a Social Stress Task on Day 1, an MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
11098006|NCT01573273|BG004|Baseline|Total|Total of all reporting groups
11098007|NCT01573273|FG000|Participant Flow|TSST Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098008|NCT01573273|FG001|Participant Flow|TSST Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098009|NCT01573273|FG002|Participant Flow|MRI 1 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098010|NCT01573273|FG003|Participant Flow|MRI 1 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098011|NCT01573273|FG004|Participant Flow|MRI 2 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098012|NCT01573273|FG005|Participant Flow|MRI 2 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098013|NCT01573273|FG006|Participant Flow|TSST Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098014|NCT01573273|FG007|Participant Flow|TSST Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098015|NCT01573273|FG008|Participant Flow|MRI I Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098016|NCT01573273|FG009|Participant Flow|MRI I Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098017|NCT01573273|FG010|Participant Flow|MRI 2 Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098018|NCT01573273|FG011|Participant Flow|MRI 2 Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098019|NCT01573273|OG000|Outcome|TSST Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098020|NCT01573273|OG001|Outcome|TSST Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098021|NCT01573273|OG002|Outcome|TSST Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098022|NCT01573273|OG003|Outcome|TSST Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098023|NCT01573273|OG000|Outcome|MRI 1 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans.~Oxytocin: intranasal administration, 40 IUs"
11098024|NCT01573273|OG001|Outcome|MRI 1 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the first of two MRI scans.~Saline: intranasal administration, 40 IUs"
11098025|NCT01573273|OG002|Outcome|MRI 1 Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans.~Oxytocin: intranasal administration, 40 IUs"
11098026|NCT01573273|OG003|Outcome|MRI 1 Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the first of two MRI scans.~Saline: intranasal administration, 40 IUs"
11098027|NCT01573273|OG000|Outcome|MRI 2 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans.~Oxytocin: intranasal administration, 40 IUs"
11098028|NCT01573273|OG001|Outcome|MRI 2 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the second of two MRI scans.~Saline: intranasal administration, 40 IUs"
11098029|NCT01573273|OG002|Outcome|MRI 2 Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans.~Oxytocin: intranasal administration, 40 IUs"
11098030|NCT01573273|OG003|Outcome|MRI 2 Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the second of two MRI scans.~Saline: intranasal administration, 40 IUs"
11098031|NCT01573273|EG000|Reported Event|TSST Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098032|NCT01573273|EG001|Reported Event|TSST Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098033|NCT01573273|EG002|Reported Event|MRI 1 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098034|NCT01573273|EG003|Reported Event|MRI 1 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098035|NCT01573273|EG004|Reported Event|MRI 2 Women Oxytocin|"Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098036|NCT01573273|EG005|Reported Event|MRI 2 Women Placebo|"Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098037|NCT01573273|EG006|Reported Event|TSST Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.~Oxytocin: intranasal administration, 40 IUs"
11098038|NCT01573273|EG007|Reported Event|TSST Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.~Saline: intranasal administration, 40 IUs"
11098039|NCT01573273|EG008|Reported Event|MRI I Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098040|NCT01573273|EG009|Reported Event|MRI I Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098041|NCT01573273|EG010|Reported Event|MRI 2 Men Oxytocin|"Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.~Oxytocin: intranasal administration, 40 IUs"
11098042|NCT01573273|EG011|Reported Event|MRI 2 Men Placebo|"Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.~Saline: intranasal administration, 40 IUs"
11098043|NCT01573325|BG000|Baseline|Study Popoulation|There was only one group as this was a descriptive prospective study
11098044|NCT01573325|FG000|Participant Flow|Study Popoulation|There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
11098045|NCT01573325|OG000|Outcome|Study Popoulation|There was only one group as this was a descriptive prospective study
11098046|NCT01573325|OG000|Outcome|Population Predicted by Have Poor HRQOL by Depressive Symptoms|
11098047|NCT01573325|EG000|Reported Event|Study Popoulation|There was only one group as this was a descriptive prospective study
11098048|NCT01573442|BG000|Baseline|Arm II (Placebo)|Patients receive placebo (0.264mL) topical application daily for six months.
11098049|NCT01573442|BG001|Baseline|Arm I (Testosterone)|Patients receive testosterone (0.264mL) topical application daily for six months.
11098050|NCT01573442|BG002|Baseline|Total|Total of all reporting groups
11098051|NCT01573442|FG000|Participant Flow|Arm II (Placebo)|Patients receive placebo (0.264mL) topical application daily for six months.
11098052|NCT01573442|FG001|Participant Flow|Arm I (Testosterone)|Patients receive testosterone (0.264mL) topical application daily for six months.
11098053|NCT01573442|OG000|Outcome|Arm II (Placebo)|Patients receive placebo (0.264mL) topical application daily for six months.
11098054|NCT01573442|OG001|Outcome|Arm I (Testosterone)|Patients receive testosterone (0.264mL) topical application daily for six months.
11098055|NCT01573442|EG000|Reported Event|Arm II (Placebo)|Patients receive placebo (0.264mL) topical application daily for six months.
11098056|NCT01573442|EG001|Reported Event|Arm I (Testosterone)|Patients receive testosterone (0.264mL) topical application daily for six months.
11098057|NCT01573533|BG000|Baseline|Rituximab|Rituximab: Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
11098058|NCT01573533|FG000|Participant Flow|Rituximab|Rituximab: Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
11098059|NCT01573533|OG000|Outcome|Rituximab|Rituximab: Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
11098060|NCT01573533|EG000|Reported Event|Rituximab|Rituximab: Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
11098061|NCT01573572|BG000|Baseline|Intravitreal Injections of Macugen|pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
11098062|NCT01573572|FG000|Participant Flow|Intravitreal Injections of Macugen|pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
11098063|NCT01573572|OG000|Outcome|Intravitreal Injections of Macugen|pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
11098064|NCT01573572|EG000|Reported Event|Intravitreal Injections of Macugen|pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
11098065|NCT01573624|BG000|Baseline|All Treatments Combined|The participants received 3 of the 7 possible treatments during the 3 double blind treatment periods. Participants received study treatments in a crossover manner according to their randomization sequence. The 7 treatment regimens were, FF 100 mcg, FF 100 mcg + UMEC 15.6 mcg, FF 100 mcg + UMEC 31.25 mcg, FF 100 mcg + UMEC 62.5 mcg, FF 100 mcg + UMEC 125 mcg, FF 100 mcg + UMEC 250 mcg and FF 100 mcg + VI 25 mcg. The study treatments were administered via a DPI taken once daily in the morning for 14 days during each study period. The treatment periods were separated by 2 washout periods of 12-14 days each. During the two week run-in period and during the two washout period, participants were administered open-label FF 100 mcg once daily in the morning via a DPI. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098066|NCT01573624|FG000|Participant Flow|FF 100 mcg First|Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication.
11098067|NCT01573624|FG001|Participant Flow|FF 100 mcg + UMEC 15.6 mcg First|Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098068|NCT01573624|FG002|Participant Flow|FF 100 mcg + UMEC 31.25 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098069|NCT01573624|FG003|Participant Flow|FF 100 mcg + UMEC 62.5 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098070|NCT01573624|FG004|Participant Flow|FF 100 mcg + UMEC 125 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098071|NCT01573624|FG005|Participant Flow|FF 100 mcg + UMEC 250 mcg First|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098072|NCT01573624|FG006|Participant Flow|FF 100 mcg + VI 25 mcg First|Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098073|NCT01573624|OG000|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098074|NCT01573624|OG001|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098075|NCT01573624|OG002|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098076|NCT01573624|OG003|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098077|NCT01573624|OG004|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098078|NCT01573624|OG000|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098079|NCT01573624|OG001|Outcome|FF 100mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098080|NCT01573624|OG002|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098081|NCT01573624|OG003|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098082|NCT01573624|OG004|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098083|NCT01573624|OG005|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098084|NCT01573624|OG006|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098085|NCT01573624|OG001|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098086|NCT01573624|EG000|Reported Event|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098087|NCT01573624|EG001|Reported Event|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098088|NCT01573624|EG002|Reported Event|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098089|NCT01573624|EG003|Reported Event|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098090|NCT01573624|EG004|Reported Event|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098091|NCT01573624|EG005|Reported Event|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098092|NCT01573624|EG006|Reported Event|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
11098093|NCT01573702|BG000|Baseline|Stereotactic Radiosurgery Followed by Erlotinib|"Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib~Stereotactic Radiosurgery: 21 Gy daily for 5 days~Erlotinib: 150mg once daily"
11098094|NCT01573702|FG000|Participant Flow|Stereotactic Radiosurgery Followed by Erlotinib|"Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib~Stereotactic Radiosurgery: 21 Gy daily for 5 days~Erlotinib: 150mg once daily"
11098095|NCT01573702|OG000|Outcome|Stereotactic Radiosurgery Followed by Erlotinib|"Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib~Stereotactic Radiosurgery: 21 Gy daily for 5 days~Erlotinib: 150mg once daily"
11098096|NCT01573702|OG000|Outcome|Single Arm Study|"Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib~Stereotactic Radiosurgery: 21 Gy daily for 5 days~Erlotinib: 150mg once daily"
11098097|NCT01573702|EG000|Reported Event|Stereotactic Radiosurgery Followed by Erlotinib|"Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib~Stereotactic Radiosurgery: 21 Gy daily for 5 days~Erlotinib: 150mg once daily"
11098098|NCT01573767|BG000|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098099|NCT01573767|BG001|Baseline|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098100|NCT01573767|BG002|Baseline|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098101|NCT01573767|BG003|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098102|NCT01573767|BG004|Baseline|Total|Total of all reporting groups
11098103|NCT01573767|FG000|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098104|NCT01573767|FG001|Participant Flow|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098105|NCT01573767|FG002|Participant Flow|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098106|NCT01573767|FG003|Participant Flow|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098107|NCT01573767|OG000|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098108|NCT01573767|OG001|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098109|NCT01573767|OG002|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098110|NCT01573767|OG003|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098111|NCT01573767|EG000|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098112|NCT01573767|EG001|Reported Event|VI 6.25 OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098113|NCT01573767|EG002|Reported Event|VI 12.5 OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098114|NCT01573767|EG003|Reported Event|VI 25 OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
11098115|NCT01573910|BG000|Baseline|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098116|NCT01573910|BG001|Baseline|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098117|NCT01573910|BG002|Baseline|Total|Total of all reporting groups
11098118|NCT01573910|FG000|Participant Flow|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098119|NCT01573910|FG001|Participant Flow|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098120|NCT01573910|OG000|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098121|NCT01573910|OG001|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098122|NCT01573910|EG000|Reported Event|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098123|NCT01573910|EG001|Reported Event|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
11098124|NCT01573949|BG000|Baseline|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11098125|NCT01573949|FG000|Participant Flow|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11098126|NCT01573949|OG000|Outcome|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11098127|NCT01573949|EG000|Reported Event|Metformin|Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
11098128|NCT01574079|BG000|Baseline|Traditional Physical Therapy|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
11328449|NCT03427268|FG000|Participant Flow|PM060184|PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
11098129|NCT01574079|BG001|Baseline|Physical Therapy Plus Mirror Therapy|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
11098130|NCT01574079|BG002|Baseline|Total|Total of all reporting groups
11098131|NCT01574079|FG000|Participant Flow|Traditional Physical Therapy|The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
11098132|NCT01574079|FG001|Participant Flow|Physical Therapy Plus Mirror Therapy|The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
11098133|NCT01574079|OG000|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
11098134|NCT01574079|OG001|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
11098135|NCT01574079|EG000|Reported Event|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
11098136|NCT01574079|EG001|Reported Event|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
11098137|NCT01574105|BG000|Baseline|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
11098138|NCT01574105|BG001|Baseline|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
11098139|NCT01574105|BG002|Baseline|Total|Total of all reporting groups
11098140|NCT01574105|FG000|Participant Flow|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
11098141|NCT01574105|FG001|Participant Flow|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
11098142|NCT01574105|OG000|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
11098143|NCT01574105|OG001|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
11098144|NCT01574105|EG000|Reported Event|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
11098145|NCT01574105|EG001|Reported Event|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
11098146|NCT01574144|BG000|Baseline|AVIVO™ PiiX Patch Monitor System|"Heart failure patients monitored continuously for 30 days post-discharge.~AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge."
11098147|NCT01574144|FG000|Participant Flow|AVIVO™ PiiX Patch Monitor System|"Heart failure patients monitored continuously for 30 days post-discharge.~AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge."
11098148|NCT01574144|OG000|Outcome|AVIVO™ PiiX Patch Monitor System|"Heart failure patients monitored continuously for 30 days post-discharge.~AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge."
11098149|NCT01574144|OG000|Outcome|Heart Failure Patients Monitored Continuously With AVIVO PiiX|AVIVO™ PiiX Patch Monitor System: External monitoring from enrollment to discharge: regression coefficient
11098150|NCT01574144|EG000|Reported Event|AVIVO™ PiiX Patch Monitor System|"Heart failure patients monitored continuously for 30 days post-discharge.~AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge."
11098151|NCT01574157|BG000|Baseline|Sodium Bicarbonate|Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
11098152|NCT01574157|BG001|Baseline|Placebo|Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
11098153|NCT01574157|BG002|Baseline|Total|Total of all reporting groups
11098154|NCT01574157|FG000|Participant Flow|Sodium Bicarbonate|Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
11098155|NCT01574157|FG001|Participant Flow|Placebo|Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
11098156|NCT01574157|OG000|Outcome|Sodium Bicarbonate|"Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months~Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses."
11328450|NCT03427268|OG000|Outcome|PM060184|PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
11098157|NCT01574157|OG001|Outcome|Placebo|"Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.~Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months."
10842837|NCT00249821|EG000|Reported Event|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
10842838|NCT00249821|EG001|Reported Event|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
10842839|NCT00249834|BG000|Baseline|Gonal-f 37.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842840|NCT00249834|BG001|Baseline|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842841|NCT00249834|BG002|Baseline|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842842|NCT00249834|BG003|Baseline|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842843|NCT00249834|BG004|Baseline|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842844|NCT00249834|BG005|Baseline|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842845|NCT00249834|BG006|Baseline|Gonal-f 262.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842846|NCT00249834|BG007|Baseline|Gonal-f 300 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842847|NCT00249834|BG008|Baseline|Total|Total of all reporting groups
10842848|NCT00249834|FG000|Participant Flow|Gonal-f 37.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 International Units (IU) per day based on assisted reproductive technology (ART) treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter were developed, a single injection of 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) was administered.
10842849|NCT00249834|FG001|Participant Flow|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842850|NCT00249834|FG002|Participant Flow|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842851|NCT00249834|FG003|Participant Flow|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842852|NCT00249834|FG004|Participant Flow|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842853|NCT00249834|FG005|Participant Flow|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
11098158|NCT01574157|OG000|Outcome|Sodium Bicarbonate|Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
11098159|NCT01574157|OG001|Outcome|Placebo|Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
11098160|NCT01574157|OG000|Outcome|Sodium Bicarbonate|Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
11098161|NCT01574157|OG001|Outcome|Placebo|Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
11098162|NCT01574157|EG000|Reported Event|Sodium Bicarbonate|Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
11098163|NCT01574157|EG001|Reported Event|Placebo|Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
11098164|NCT01574183|BG000|Baseline|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
11098165|NCT01574183|BG001|Baseline|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
11098166|NCT01574183|BG002|Baseline|Total|Total of all reporting groups
11098167|NCT01574183|FG000|Participant Flow|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
11098168|NCT01574183|FG001|Participant Flow|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
11098169|NCT01574183|OG000|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: up to 40 mg capsule daily"
11098170|NCT01574183|OG001|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: up to 40 mg capsule daily"
11098171|NCT01574183|OG000|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
11098172|NCT01574183|OG001|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
11098173|NCT01574183|EG000|Reported Event|Vilazodone|Flexible dose Vilazodone: up to 40 mg capsule daily
11098174|NCT01574183|EG001|Reported Event|Placebo|Flexible dose Placebo: up to 40 mg capsule daily
11098175|NCT01574248|BG000|Baseline|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
11098176|NCT01574248|BG001|Baseline|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
11098177|NCT01574248|BG002|Baseline|Total|Total of all reporting groups
11098178|NCT01574248|FG000|Participant Flow|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
11098179|NCT01574248|FG001|Participant Flow|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
11098180|NCT01574248|OG000|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
11098181|NCT01574248|OG001|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
11098182|NCT01574248|EG000|Reported Event|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
11098183|NCT01574248|EG001|Reported Event|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
11098184|NCT01574287|BG000|Baseline|FACBC|FACBC: Drug is give intravenously over 2 minutes at time of scan
11098185|NCT01574287|FG000|Participant Flow|FACBC|FACBC: Drug is give intravenously over 2 minutes at time of scan
11098186|NCT01574287|OG000|Outcome|FACBC|FACBC: Drug is give intravenously over 2 minutes at time of scan
11098187|NCT01574287|EG000|Reported Event|FACBC|FACBC: Drug is give intravenously over 2 minutes at time of scan
11098188|NCT01574326|BG000|Baseline|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
11098189|NCT01574326|BG001|Baseline|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
11098190|NCT01574326|BG002|Baseline|Total|Total of all reporting groups
11328451|NCT03427268|EG000|Reported Event|PM060184|PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
11098191|NCT01574326|FG000|Participant Flow|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
11098192|NCT01574326|FG001|Participant Flow|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
11098193|NCT01574326|OG000|Outcome|FDP-Placebo for Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
11098194|NCT01574326|OG001|Outcome|FDP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
11098195|NCT01574326|OG000|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
11098196|NCT01574326|OG001|Outcome|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
11098197|NCT01574326|OG000|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
11098198|NCT01574326|OG001|Outcome|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
11098199|NCT01574326|EG000|Reported Event|FDP - Placebo|Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).
11098200|NCT01574326|EG001|Reported Event|FDP - Sevelamer Carbonate|Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).
11098201|NCT01574326|EG002|Reported Event|DTP - Sevelamer Carbonate|Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
11098202|NCT01574352|BG000|Baseline|Intervention Camp|"Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.~Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.~A subsequent 46 weeks family based intervention took place after the camp was completed."
11098203|NCT01574352|BG001|Baseline|Standard Intervention|Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
11098204|NCT01574352|BG002|Baseline|Total|Total of all reporting groups
11098205|NCT01574352|FG000|Participant Flow|Intervention Camp|"Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.~Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.~A subsequent 46 weeks family based intervention took place after the camp was completed."
11098206|NCT01574352|FG001|Participant Flow|Standard Intervention|Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
11098207|NCT01574352|OG000|Outcome|Intervention Camp|"Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.~Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.~A subsequent 46 weeks family based intervention took place after the camp was completed."
11098208|NCT01574352|OG001|Outcome|Standard Intervention|Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
11098209|NCT01574352|EG000|Reported Event|Camp Intervention|"The intervention camp consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention.~The standard care arm was offered two weekly hours of physical activity training for six weeks."
11098210|NCT01574352|EG001|Reported Event|Standard Internvention|In the Standard intervention children were offered a weekly 1-hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
11098211|NCT01574612|BG000|Baseline|Topical Cream|xerese topical cream is the only active used in this trial
11098212|NCT01574612|FG000|Participant Flow|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
11098213|NCT01574612|OG000|Outcome|Topical Cream|commercial cream used
11098214|NCT01574612|EG000|Reported Event|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
11098215|NCT01574651|BG000|Baseline|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
11098216|NCT01574651|BG001|Baseline|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
11098217|NCT01574651|BG002|Baseline|Total|Total of all reporting groups
11098218|NCT01574651|FG000|Participant Flow|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
11098219|NCT01574651|FG001|Participant Flow|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
11098220|NCT01574651|OG000|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
11098221|NCT01574651|OG001|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
11098222|NCT01574651|EG000|Reported Event|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
11098223|NCT01574651|EG001|Reported Event|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
11098224|NCT01574703|BG000|Baseline|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
11098225|NCT01574703|BG001|Baseline|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
11098226|NCT01574703|BG002|Baseline|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
11098227|NCT01574703|BG003|Baseline|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
11098228|NCT01574703|BG004|Baseline|Total|Total of all reporting groups
11098229|NCT01574703|FG000|Participant Flow|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
11098230|NCT01574703|FG001|Participant Flow|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
11098231|NCT01574703|FG002|Participant Flow|Nicotine Replacement Therapy (NRT) Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
11098232|NCT01574703|FG003|Participant Flow|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
11098233|NCT01574703|OG000|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
11098234|NCT01574703|OG001|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
11098235|NCT01574703|OG002|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
11098236|NCT01574703|OG003|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
11098237|NCT01574703|EG000|Reported Event|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
11098238|NCT01574703|EG001|Reported Event|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
11098239|NCT01574703|EG002|Reported Event|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
11098240|NCT01574703|EG003|Reported Event|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
11098241|NCT01574716|BG000|Baseline|Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098242|NCT01574716|BG001|Baseline|Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098243|NCT01574716|BG002|Baseline|Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098244|NCT01574716|BG003|Baseline|Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098245|NCT01574716|BG004|Baseline|Part 2: Placebo + Gemcitabine/Docetaxel|Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098246|NCT01574716|BG005|Baseline|Total|Total of all reporting groups
11098247|NCT01574716|FG000|Participant Flow|Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 4 milligram per kilogram (mg/kg), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 milligram per square meter (mg/m^2), infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098248|NCT01574716|FG001|Participant Flow|Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098249|NCT01574716|FG002|Participant Flow|Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098250|NCT01574716|FG003|Participant Flow|Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098251|NCT01574716|FG004|Participant Flow|Part 2: Placebo + Gemcitabine/Docetaxel|Participants received normal saline (0.9 percent [%] sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098252|NCT01574716|OG000|Outcome|Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098253|NCT01574716|OG001|Outcome|Part 2: Placebo + Gemcitabine/Docetaxel|Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098254|NCT01574716|EG000|Reported Event|Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098255|NCT01574716|EG001|Reported Event|Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098256|NCT01574716|EG002|Reported Event|Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098257|NCT01574716|EG003|Reported Event|Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel|Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098258|NCT01574716|EG004|Reported Event|Part 2: Placebo + Gemcitabine/Docetaxel|Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
11098259|NCT01574807|BG000|Baseline|All Participants|All participants receive 3% mepivacaine + 2% lidocaine versus 2% lidocaine + 2% lidocaine injections in different randomized sequences.
11098260|NCT01574807|FG000|Participant Flow|Mepi/Lido + Lido/Lido Group|This group received Mepivacaine + lidocaine at 1st appointment and lidocaine + lidocaine at 2nd appointment.
11098261|NCT01574807|FG001|Participant Flow|Lido/Lido + Mepi/Lido Group|This group received injections of lidocaine + lidocaine at 1st appointment and Mepivacaine + lidocaine at second appointment.
11098262|NCT01574807|OG000|Outcome|Mepivacaine + Lidocaine|Clinical appointment where: 1.8cc 3% mepivacine + 1.8cc 2% lidocaine is injected.
11098263|NCT01574807|OG001|Outcome|Lidocaine + Lidocaine|Clinical appointment where - 1.8cc 2% lidocaine + 1.8cc 2% lidocaine is injected.
11098264|NCT01574807|EG000|Reported Event|Treatment Group|3% mepivacaine/2% lidocaine with epinephrine - combination 1
11098265|NCT01575054|BG000|Baseline|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098266|NCT01575054|BG001|Baseline|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098267|NCT01575054|BG002|Baseline|Total|Total of all reporting groups
11098268|NCT01575054|FG000|Participant Flow|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098269|NCT01575054|FG001|Participant Flow|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098270|NCT01575054|OG000|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098271|NCT01575054|OG001|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
11098272|NCT01575054|EG000|Reported Event|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
11098273|NCT01575054|EG001|Reported Event|Normal Saline (Placebo)|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
11098274|NCT01575080|BG000|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
11098275|NCT01575080|FG000|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
11098276|NCT01575080|OG000|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
11098277|NCT01575080|EG000|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
11098278|NCT01575106|BG000|Baseline|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
11098279|NCT01575106|FG000|Participant Flow|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
11098280|NCT01575106|OG000|Outcome|Heat Pain|"There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
11098281|NCT01575106|EG000|Reported Event|Heat Pain|"All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.~Heat pain applied using TSA or CHEPS: TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)"
11098282|NCT01575106|EG001|Reported Event|Cream|All subjects were told they would receive lidocaine, capsaicin, and neutral cream on their forearm, but in reality they only received neutral cream (regular moisturizing lotion).
11098283|NCT01575197|BG000|Baseline|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
11098284|NCT01575197|BG001|Baseline|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
11098285|NCT01575197|BG002|Baseline|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
11098286|NCT01575197|BG003|Baseline|Total|Total of all reporting groups
11098287|NCT01575197|FG000|Participant Flow|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age.
11098288|NCT01575197|FG001|Participant Flow|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age.
11098289|NCT01575197|FG002|Participant Flow|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age.
11098290|NCT01575197|OG000|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
11098291|NCT01575197|OG001|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
11098292|NCT01575197|OG001|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
11098293|NCT01575197|EG000|Reported Event|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
11098294|NCT01575197|EG001|Reported Event|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
11098295|NCT01575197|EG002|Reported Event|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
11328452|NCT03427619|BG000|Baseline|OK-432|"OK 432 is a lyophilized biological preparation for injection containing nonviable cells of Streptococcus pyogenes (A group, type 3) Su strain treated with benzylpenicillin.~OK-432 was administered intracystically at a concentration of 0.01 to 0.05 mg/mL. A 4-dose injection series of OK-432 was planned for all subjects. All injections were spaced approximately 6 to 12 weeks apart"
11218034|NCT02318602|EG001|Reported Event|Children|"Participants 2 to <12 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218035|NCT02318602|EG002|Reported Event|Adolescents|"Participants 12 to ≤17 years of age. Participants who completed INS011-14-029 initiated this study on the dose with which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~Participants who enrolled from INS011-15-054 continued treatment with the dose at which they were being treated previously, and dose modifications were made at the Investigator's discretion if tolerability or efficacy issues were observed for a particular participant.~The total daily dose (mg/kg/day) will be evenly split between morning and evening doses (12 hours apart). If tolerability issues arise, the participant's dose may be changed at the investigator's discretion."
11218036|NCT02318667|BG000|Baseline|Golimumab Treatment|Golimumab 200 mg initially administered by subcutaneous (SC) injection at Week 0, followed by 100 mg at Week 2 and then 50 mg or 100 mg every 4 weeks (per prescribing information) up to 16 weeks.
11218037|NCT02318667|FG000|Participant Flow|Golimumab Treatment|Golimumab 200 mg initially administered by subcutaneous (SC) injection at Week 0, followed by 100 mg at Week 2 and then 50 mg or 100 mg every 4 weeks (per prescribing information) up to 16 weeks.
11218038|NCT02318667|OG000|Outcome|Golimumab Treatment|Golimumab 200 mg initially administered by subcutaneous (SC) injection at Week 0, followed by 100 mg at Week 2 and then 50 mg or 100 mg every 4 weeks (per prescribing information) up to 16 weeks.
11218039|NCT02318667|OG000|Outcome|Inactive Disease|Participants with inactive Ulcerative Colitis at Week 6
11218040|NCT02318667|OG001|Outcome|Active Disease|Participants with active Ulcerative Colitis at Week 6
11218041|NCT02318667|OG000|Outcome|Maintained Endoscopic Response|Participants who achieved endoscopic response at Week 6 and maintained endoscopic response at Week 16
11218042|NCT02318667|OG001|Outcome|Did Not Maintain Endoscopic Response|Participants who achieved endoscopic response at Week 6 and did not maintain endoscopic response at Week 16
11218043|NCT02318667|EG000|Reported Event|Golimumab Treatment|Golimumab 200 mg initially administered by subcutaneous (SC) injection at Week 0, followed by 100 mg at Week 2 and then 50 mg or 100 mg every 4 weeks (per prescribing information) up to 16 weeks.
11218044|NCT02318693|BG000|Baseline|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11218045|NCT02318693|BG001|Baseline|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11218046|NCT02318693|BG002|Baseline|Total|Total of all reporting groups
11218047|NCT02318693|FG000|Participant Flow|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11218048|NCT02318693|FG001|Participant Flow|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
11218049|NCT02318693|OG000|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11218050|NCT02318693|OG001|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11218051|NCT02318693|EG000|Reported Event|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11218052|NCT02318693|EG001|Reported Event|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11218053|NCT02318706|BG000|Baseline|Placebo|Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.
11218054|NCT02318706|BG001|Baseline|DS-5565 15mg QD|"Participants who received an oral dose of DS-5565 15 mg QD.~During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.~During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks."
11218055|NCT02318706|BG002|Baseline|DS-5565 20 mg (10 mg BID)|"Participants who received an oral dose of DS-5565 20 mg (10 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.~During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks."
11218056|NCT02318706|BG003|Baseline|DS-5565 30 mg (15 mg BID)|"Participants who received an oral dose of DS-5565 30 mg (15 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.~During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks."
11218057|NCT02318706|BG004|Baseline|Total|Total of all reporting groups
11218058|NCT02318706|FG000|Participant Flow|Placebo|Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.
11218059|NCT02318706|FG001|Participant Flow|DS-5565 15mg QD|"Participants who received an oral dose of DS-5565 15 mg every day (QD).~During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.~During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks."
11218060|NCT02318706|FG002|Participant Flow|DS-5565 20 mg (10 mg BID)|"Participants who received an oral dose of DS-5565 20 mg (10 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.~During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks."
11218061|NCT02318706|FG003|Participant Flow|DS-5565 30 mg (15 mg BID)|"Participants who received an oral dose of DS-5565 30 mg (15 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.~During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks."
11218062|NCT02318706|FG004|Participant Flow|DS-5565 Open-label Extension|Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218063|NCT02318706|OG000|Outcome|Placebo|Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.
11218064|NCT02318706|OG001|Outcome|DS-5565 15mg QD|"Participants who received an oral dose of DS-5565 15 mg every day (QD).~During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.~During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks."
11218065|NCT02318706|OG002|Outcome|DS-5565 20 mg (10 mg BID)|"Participants who received an oral dose of DS-5565 20 mg (10 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.~During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks."
11218066|NCT02318706|OG003|Outcome|DS-5565 30 mg (15 mg BID)|"Participants who received an oral dose of DS-5565 30 mg (15 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.~During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks."
11218067|NCT02318706|OG000|Outcome|DS-5565 Open-label Extension|Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218068|NCT02318706|EG000|Reported Event|Placebo|Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.
11218069|NCT02318706|EG001|Reported Event|DS-5565 15mg QD|"Participants who received an oral dose of DS-5565 15 mg every day (QD).~During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.~During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks."
11218070|NCT02318706|EG002|Reported Event|DS-5565 20 mg (10 mg BID)|"Participants who received an oral dose of DS-5565 20 mg (10 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.~During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks."
11218071|NCT02318706|EG003|Reported Event|DS-5565 30 mg (15 mg BID)|"Participants who received an oral dose of DS-5565 30 mg (15 mg BID).~During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.~During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks."
11218072|NCT02318706|EG004|Reported Event|DS-5565 Open-label Extension|Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218073|NCT02318719|BG000|Baseline|Placebo|Participants who received placebo for 14 weeks.
11218074|NCT02318719|BG001|Baseline|DS-5565 15 mg|Participants who received oral administration of DS-5565 15 mg with a 2 week titration and 12 weeks fixed dose treatment period.
11218075|NCT02318719|BG002|Baseline|DS-5565 20 mg|Participants who received oral administration of DS-5565 20 mg with a 1 week titration and 13 weeks fixed dose treatment period.
11218076|NCT02318719|BG003|Baseline|DS-5565 30 mg|Participants who received oral administration of DS-5565 30 mg with a 2 week titration and 12 weeks fixed dose treatment period.
11218077|NCT02318719|BG004|Baseline|Total|Total of all reporting groups
11218078|NCT02318719|FG000|Participant Flow|Placebo|Participants who received placebo for 14 weeks.
11218079|NCT02318719|FG001|Participant Flow|DS-5565 15 mg/Day|Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day).
11218080|NCT02318719|FG002|Participant Flow|DS-5565 20 mg/Day|Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID).
11218081|NCT02318719|FG003|Participant Flow|DS-5565 30 mg/Day|Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID).
11218082|NCT02318719|FG004|Participant Flow|DS-5565 Open-label Extension|Participants who received 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218083|NCT02318719|OG000|Outcome|Placebo|Participants who received placebo for 14 weeks.
11218084|NCT02318719|OG001|Outcome|DS-5565 15 mg/Day|Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day).
11218085|NCT02318719|OG002|Outcome|DS-5565 20 mg/Day|Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID).
11218086|NCT02318719|OG003|Outcome|DS-5565 30 mg/Day|Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID).
11218087|NCT02318719|OG000|Outcome|DS-5565 Open-label Extension|Participants who received 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218088|NCT02318719|EG000|Reported Event|Placebo|Participants who received placebo for 14 weeks.
11218089|NCT02318719|EG001|Reported Event|DS-5565 15 mg/Day|Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day).
11218090|NCT02318719|EG002|Reported Event|DS-5565 20 mg/Day|Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID).
11218091|NCT02318719|EG003|Reported Event|DS-5565 30 mg/Day|Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID).
11218092|NCT02318719|EG004|Reported Event|DS-5565 Open-label Extension|Participants who received 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
11218093|NCT02318797|BG000|Baseline|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
11218094|NCT02318797|BG001|Baseline|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
11218095|NCT02318797|BG002|Baseline|Total|Total of all reporting groups
11218096|NCT02318797|FG000|Participant Flow|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
11218097|NCT02318797|FG001|Participant Flow|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
11218098|NCT02318797|OG000|Outcome|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
11218099|NCT02318797|OG001|Outcome|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
11218100|NCT02318797|EG000|Reported Event|Patient Self-Directed Care|"See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs"
11218101|NCT02318797|EG001|Reported Event|Provider-Supported Integrated Care|"See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education"
11218102|NCT02318940|BG000|Baseline|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11218103|NCT02318940|BG001|Baseline|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11218104|NCT02318940|BG002|Baseline|Total|Total of all reporting groups
11218105|NCT02318940|FG000|Participant Flow|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11218106|NCT02318940|FG001|Participant Flow|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11218107|NCT02318940|OG000|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11218108|NCT02318940|OG001|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11218109|NCT02318940|EG000|Reported Event|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11218110|NCT02318940|EG001|Reported Event|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11218111|NCT02318979|BG000|Baseline|Running|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218112|NCT02318979|BG001|Baseline|Sprinting|"Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218113|NCT02318979|BG002|Baseline|Total|Total of all reporting groups
11218114|NCT02318979|FG000|Participant Flow|Running|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218115|NCT02318979|FG001|Participant Flow|Sprinting|"Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218116|NCT02318979|OG000|Outcome|Running|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218117|NCT02318979|OG001|Outcome|Sprinting|"Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218118|NCT02318979|OG000|Outcome|Running - Unilateral|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218119|NCT02318979|OG001|Outcome|Running-Bilateral|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218120|NCT02318979|OG000|Outcome|Sprinting - Unilateral|"Participants will run over a range of speeds up to their top speed on an instrumented treadmill using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218121|NCT02318979|OG001|Outcome|Sprinting - Bilateral|"Participants will run over a range of speeds up to their top speed on an instrumented treadmill using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218122|NCT02318979|EG000|Reported Event|Running|"Participants will run on an instrumented treadmill at one speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218123|NCT02318979|EG001|Reported Event|Sprinting|"Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.~Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter."
11218124|NCT02318992|BG000|Baseline|Fecal Microbiota_Fresh|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was used within 2 hours of preparation (Fresh).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218125|NCT02318992|BG001|Baseline|Fecal Microbiota_Frozen|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 degrees celsius (C) freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218126|NCT02318992|BG002|Baseline|Fecal Microbiota_Lyophilized|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day.~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218127|NCT02318992|BG003|Baseline|Total|Total of all reporting groups
11218128|NCT02318992|FG000|Participant Flow|Fecal Microbiota_Fresh|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 milliliters (mL)) was used within 2 hours of preparation (Fresh).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218129|NCT02318992|FG001|Participant Flow|Fecal Microbiota_Frozen|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 degrees celsius (C) freezer labeled with identity (ID) and expiration date which was 6 months after preparation day (Frozen).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218130|NCT02318992|FG002|Participant Flow|Fecal Microbiota_Lyophilized|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 milliliters (mL)) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day.~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218131|NCT02318992|OG000|Outcome|Fecal Microbiota_Fresh|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was used within 2 hours of preparation (Fresh).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218132|NCT02318992|OG001|Outcome|Fecal Microbiota_Frozen|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218133|NCT02318992|OG002|Outcome|Fecal Microbiota_Lyophilized|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218134|NCT02318992|EG000|Reported Event|Fecal Microbiota_Fresh|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was used within 2 hours of preparation (Fresh).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218135|NCT02318992|EG001|Reported Event|Fecal Microbiota_Frozen|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218136|NCT02318992|EG002|Reported Event|Fecal Microbiota_Lyophilized|"Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.~Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy."
11218137|NCT02319031|BG000|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218138|NCT02319031|BG001|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218139|NCT02319031|BG002|Baseline|Total|Total of all reporting groups
11218140|NCT02319031|FG000|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218141|NCT02319031|FG001|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218142|NCT02319031|OG000|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218143|NCT02319031|OG001|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218144|NCT02319031|EG000|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218145|NCT02319031|EG001|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11218146|NCT02319044|BG000|Baseline|MEDI4736 + Tremelimumab|MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
11218147|NCT02319044|BG001|Baseline|MEDI4736|MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
11218148|NCT02319044|BG002|Baseline|Tremelimumab|Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
11218149|NCT02319044|BG003|Baseline|Total|Total of all reporting groups
11218150|NCT02319044|FG000|Participant Flow|MEDI4736 AND TREMELIMUMAB COMBINATION|MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
11218151|NCT02319044|FG001|Participant Flow|MEDI4736|MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
11218152|NCT02319044|FG002|Participant Flow|Tremelimumab|Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
11218153|NCT02319044|OG000|Outcome|MEDI4736 + Tremelimumab|MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
11218154|NCT02319044|OG001|Outcome|MEDI4736|MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
11218155|NCT02319044|OG002|Outcome|Tremelimumab|Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
11218156|NCT02319044|OG003|Outcome|Total|Total across all treatment groups
11218157|NCT02319044|EG000|Reported Event|MEDI4736 AND TREMELIMUMAB COMBINATION|MEDI4736 (20 mg/kg) + Tremelimumab (1 mg/kg) combination therapy administered via intravenous infusion every 4 weeks for up to 4 months (4 doses), then MEDI4736 (10 mg/kg) as a single agent every 2 weeks to complete 12 months of treatment
11218158|NCT02319044|EG001|Reported Event|MEDI4736|MEDI4736 (10 mg/kg) monotherapy administered via intravenous infusion every 2 weeks for up to 12 months (up to 26 doses)
11218159|NCT02319044|EG002|Reported Event|Tremelimumab|Tremelimumab (10 mg/kg) monotherapy administered via intravenous infusion every 4 weeks for 7 doses, then every 12 weeks for 2 additional doses for up to 12 months (up to 9 doses)
11218160|NCT02319148|BG000|Baseline|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11218161|NCT02319148|BG001|Baseline|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11218162|NCT02319148|BG002|Baseline|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11218163|NCT02319148|BG003|Baseline|Total|Total of all reporting groups
11218164|NCT02319148|FG000|Participant Flow|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11218165|NCT02319148|FG001|Participant Flow|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11218166|NCT02319148|FG002|Participant Flow|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11218167|NCT02319148|FG003|Participant Flow|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11218168|NCT02319148|OG000|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11218169|NCT02319148|OG001|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11218170|NCT02319148|OG002|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11218171|NCT02319148|OG003|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11218172|NCT02319148|OG001|Outcome|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
11218173|NCT02319148|OG002|Outcome|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
11218174|NCT02319148|OG003|Outcome|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
11218175|NCT02319148|OG004|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11218176|NCT02319148|OG005|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11218177|NCT02319148|OG006|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11218178|NCT02319148|EG000|Reported Event|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11218179|NCT02319148|EG001|Reported Event|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
11218180|NCT02319148|EG002|Reported Event|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
11218181|NCT02319148|EG003|Reported Event|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
11218182|NCT02319148|EG004|Reported Event|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11218183|NCT02319148|EG005|Reported Event|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11218184|NCT02319148|EG006|Reported Event|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11218185|NCT02319174|BG000|Baseline|Sphygmo|"All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women.~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11218186|NCT02319174|FG000|Participant Flow|Sphygmo|"All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women.~Sphygmo: A team of engineers from Rice University recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11218187|NCT02319174|OG000|Outcome|Sphygmo|"All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women.~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11218188|NCT02319174|OG001|Outcome|Dinamap|"All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women.~Dinamap: Dinamap is a commercially available, ambulatory, blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11218189|NCT02319174|EG000|Reported Event|Sphygmo|"All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women.~Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals"
11218190|NCT02319304|BG000|Baseline|Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX|"Part I:~FOLFOX: combination of drugs administered in a specific sequence as prescribed below.~Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours~Leucovorin: 200 mg/m2 IV bolus over 2 hours~5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours~Part II:~Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles~FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description~Low dose fractionated radiation therapy (LDFRT): see arm description"
11218191|NCT02319304|FG000|Participant Flow|Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX|"Part I:~FOLFOX: combination of drugs administered in a specific sequence as prescribed below.~Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours~Leucovorin: 200 mg/m2 IV bolus over 2 hours~5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours~Part II:~Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles~FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description~Low dose fractionated radiation therapy (LDFRT): see arm description"
11218192|NCT02319304|OG000|Outcome|Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX|"Part I:~FOLFOX: combination of drugs administered in a specific sequence as prescribed below.~Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours~Leucovorin: 200 mg/m2 IV bolus over 2 hours~5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours~Part II:~Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles~FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description~Low dose fractionated radiation therapy (LDFRT): see arm description"
11218193|NCT02319304|EG000|Reported Event|Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX|"Part I:~FOLFOX: combination of drugs administered in a specific sequence as prescribed below.~Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours~Leucovorin: 200 mg/m2 IV bolus over 2 hours~5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours~Part II:~Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles~FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description~Low dose fractionated radiation therapy (LDFRT): see arm description"
11218194|NCT02319317|BG000|Baseline|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
11218195|NCT02319317|BG001|Baseline|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
11218196|NCT02319317|BG002|Baseline|Total|Total of all reporting groups
11218197|NCT02319317|FG000|Participant Flow|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
11218198|NCT02319317|FG001|Participant Flow|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
11218199|NCT02319317|OG000|Outcome|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
11218200|NCT02319317|OG001|Outcome|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
11218201|NCT02319317|EG000|Reported Event|Risky Driving Prevention|"Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.~Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway."
11218202|NCT02319317|EG001|Reported Event|Control Group|"Web-based behavioral intervention for healthy lifestyles.~Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease."
11218203|NCT02319369|BG000|Baseline|Cohort 1: Milademetan 60 mg|Participants were administered 60 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218204|NCT02319369|BG001|Baseline|Cohort 2: Milademetan 90 mg|Participants were administered 90 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218205|NCT02319369|BG002|Baseline|Cohort 3: Milademetan 120 mg|Participants were administered 120 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218206|NCT02319369|BG003|Baseline|Cohort 4: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218207|NCT02319369|BG004|Baseline|Cohort 5: Milademetan 210 mg|Participants were administered 210 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle
11218208|NCT02319369|BG005|Baseline|Cohort 6b: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 7 of a 28-day cycle.
11218209|NCT02319369|BG006|Baseline|Cohort 7c: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules for 3 of 14 days repeated twice in a 28-day cycle.
11218210|NCT02319369|BG007|Baseline|Cohort 8d: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218211|NCT02319369|BG008|Baseline|Cohort 9d: Milademetan 220 mg|Participants were administered 220 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218212|NCT02319369|BG009|Baseline|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218213|NCT02319369|BG010|Baseline|Cohort 11f: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218214|NCT02319369|BG011|Baseline|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218215|NCT02319369|BG012|Baseline|Cohort 13f: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218216|NCT02319369|BG013|Baseline|Total|Total of all reporting groups
11218217|NCT02319369|FG000|Participant Flow|Cohort 1: Milademetan 60 mg|Participants were administered 60 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218218|NCT02319369|FG001|Participant Flow|Cohort 2: Milademetan 90 mg|Participants were administered 90 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218219|NCT02319369|FG002|Participant Flow|Cohort 3: Milademetan 120 mg|Participants were administered 120 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218220|NCT02319369|FG003|Participant Flow|Cohort 4: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218221|NCT02319369|FG004|Participant Flow|Cohort 5: Milademetan 210 mg|Participants were administered 210 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle
11218222|NCT02319369|FG005|Participant Flow|Cohort 6b: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 7 of a 28-day cycle.
11218223|NCT02319369|FG006|Participant Flow|Cohort 7c: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules for 3 of 14 days repeated twice in a 28-day cycle.
11218224|NCT02319369|FG007|Participant Flow|Cohort 8d: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218225|NCT02319369|FG008|Participant Flow|Cohort 9d: Milademetan 220 mg|Participants were administered 220 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218226|NCT02319369|FG009|Participant Flow|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218227|NCT02319369|FG010|Participant Flow|Cohort 11f: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218228|NCT02319369|FG011|Participant Flow|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218229|NCT02319369|FG012|Participant Flow|Cohort 13f: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218230|NCT02319369|OG000|Outcome|Cohort 1: Milademetan 60 mg|Participants were administered 60 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218231|NCT02319369|OG001|Outcome|Cohort 4: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218232|NCT02319369|OG002|Outcome|Cohort 5: Milademetan 210 mg|Participants were administered 210 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle
11218233|NCT02319369|OG003|Outcome|Cohort 9d: Milademetan 220 mg|Participants were administered 220 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218234|NCT02319369|OG004|Outcome|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218235|NCT02319369|OG001|Outcome|Cohort 2: Milademetan 90 mg|Participants were administered 90 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218236|NCT02319369|OG002|Outcome|Cohort 3: Milademetan 120 mg|Participants were administered 120 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218237|NCT02319369|OG003|Outcome|Cohort 4: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218238|NCT02319369|OG004|Outcome|Cohort 5: Milademetan 210 mg|Participants were administered 210 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle
11218239|NCT02319369|OG005|Outcome|Cohort 6b: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 7 of a 28-day cycle.
11218240|NCT02319369|OG006|Outcome|Cohort 7c: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules for 3 of 14 days repeated twice in a 28-day cycle.
11218241|NCT02319369|OG007|Outcome|Cohort 8d: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218242|NCT02319369|OG008|Outcome|Cohort 9d: Milademetan 220 mg|Participants were administered 220 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218243|NCT02319369|OG009|Outcome|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218244|NCT02319369|OG010|Outcome|Cohort 11f: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218245|NCT02319369|OG011|Outcome|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218246|NCT02319369|OG012|Outcome|Cohort 13f: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218247|NCT02319369|OG000|Outcome|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218248|NCT02319369|OG001|Outcome|Cohort 11f: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218249|NCT02319369|OG002|Outcome|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218250|NCT02319369|OG003|Outcome|Cohort 13f: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218251|NCT02319369|OG000|Outcome|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as a single oral capsule on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218252|NCT02319369|OG005|Outcome|Cohort 7c: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules for 3 of 14 days repeated twice in a 28-day cycle.
11218253|NCT02319369|EG000|Reported Event|Cohort 1: Milademetan 60 mg|Participants were administered 60 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218254|NCT02319369|EG001|Reported Event|Cohort 2: Milademetan 90 mg|Participants were administered 90 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218255|NCT02319369|EG002|Reported Event|Cohort 3: Milademetan 120 mg|Participants were administered 120 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218256|NCT02319369|EG003|Reported Event|Cohort 4: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle.
11218257|NCT02319369|EG004|Reported Event|Cohort 5: Milademetan 210 mg|Participants were administered 210 mg milademetan daily as oral capsules on Days 1 to 21 of a 28-day cycle
11218258|NCT02319369|EG005|Reported Event|Cohort 6b: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 7 of a 28-day cycle.
11218259|NCT02319369|EG006|Reported Event|Cohort 7c: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules for 3 of 14 days repeated twice in a 28-day cycle.
11218260|NCT02319369|EG007|Reported Event|Cohort 8d: Milademetan 160 mg|Participants were administered 160 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218261|NCT02319369|EG008|Reported Event|Cohort 9d: Milademetan 220 mg|Participants were administered 220 mg milademetan daily as oral capsules on Days 1 to 14 of a 28-day cycle.
11218262|NCT02319369|EG009|Reported Event|Cohort 10e: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218263|NCT02319369|EG010|Reported Event|Cohort 11f: Milademetan 160 mg + Azacitidine 75 mg/m^2|Participants were administered 160 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218264|NCT02319369|EG011|Reported Event|Cohort 12e: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 5 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218265|NCT02319369|EG012|Reported Event|Cohort 13f: Milademetan 200 mg + Azacitidine 75 mg/m^2|Participants were administered 200 mg milademetan daily as oral capsules on Days 8 to 14 of a 28-day cycle and azacitidine was administered on Days 1 to 7.
11218266|NCT02319486|BG000|Baseline|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11218267|NCT02319486|FG000|Participant Flow|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11218268|NCT02319486|OG000|Outcome|CEV With/Without Carboplatin- Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11218269|NCT02319486|OG001|Outcome|CEV With/Without Carboplatin - Stage 3|CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
11218270|NCT02319486|EG000|Reported Event|CEV With/Without Carboplatin-Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11218271|NCT02319486|EG001|Reported Event|CEV With/Without Carboplatin-Stage 3|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11218272|NCT02319525|BG000|Baseline|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11218273|NCT02319525|BG001|Baseline|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11218274|NCT02319525|BG002|Baseline|Total|Total of all reporting groups
11218275|NCT02319525|FG000|Participant Flow|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11218276|NCT02319525|FG001|Participant Flow|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11218277|NCT02319525|OG000|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11218278|NCT02319525|OG001|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11328453|NCT03427619|FG000|Participant Flow|OK-432|"OK 432 is a lyophilized biological preparation for injection containing nonviable cells of Streptococcus pyogenes (A group, type 3) Su strain treated with benzylpenicillin.~OK-432 was administered intracystically at a concentration of 0.01 to 0.05 mg/mL. A 4-dose injection series of OK-432 was planned for all subjects. All injections were spaced approximately 6 to 12 weeks apart"
11218279|NCT02319525|EG000|Reported Event|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11218280|NCT02319525|EG001|Reported Event|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11218281|NCT02319642|BG000|Baseline|Open-label Cimzia (Placebo in Feeder Study)|Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218282|NCT02319642|BG001|Baseline|Open-label Cimzia (Cimzia in Feeder Study)|Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218283|NCT02319642|BG002|Baseline|Total Title|
11218284|NCT02319642|FG000|Participant Flow|Open-label Cimzia (Placebo in Feeder Study)|Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218285|NCT02319642|FG001|Participant Flow|Open-label Cimzia (Cimzia in Feeder Study)|Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218286|NCT02319642|OG000|Outcome|Open-label Cimzia (Placebo in Feeder Study)|Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218287|NCT02319642|OG001|Outcome|Open-label Cimzia (Cimzia in Feeder Study)|Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218288|NCT02319642|OG000|Outcome|Open-label Cimzia (Placebo in Feeder Study)|Subjects were treated with Placebo in study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218289|NCT02319642|OG001|Outcome|Open-label Cimzia (Cimzia in Feeder Study)|Subjects were treated with CZP in study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218290|NCT02319642|EG000|Reported Event|Open-label Cimzia (Placebo in Feeder Study)|Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11218291|NCT02319642|EG001|Reported Event|Open-label Cimzia (Cimzia in Feeder Study)|Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
11328454|NCT03427619|OG000|Outcome|OK-432|"OK 432 is a lyophilized biological preparation for injection containing nonviable cells of Streptococcus pyogenes (A group, type 3) Su strain treated with benzylpenicillin.~OK-432 was administered intracystically at a concentration of 0.01 to 0.05 mg/mL. A 4-dose injection series of OK-432 was planned for all subjects. All injections were spaced approximately 6 to 12 weeks apart"
11218292|NCT02319668|BG000|Baseline|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
11218293|NCT02319668|BG001|Baseline|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
11218294|NCT02319668|BG002|Baseline|Total|Total of all reporting groups
11218295|NCT02319668|FG000|Participant Flow|Test and Reference Product|Participants rinsed for one timed minute with 10 milliliter (mL) of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
11218296|NCT02319668|FG001|Participant Flow|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
11218297|NCT02319668|OG000|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
11218298|NCT02319668|OG001|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
11218299|NCT02319668|OG000|Outcome|Test and Reference Products|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
11218300|NCT02319668|OG000|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product only (mouthwash containing Chlorhexidine digluconate). Participants did not receive reference product(toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
11218301|NCT02319668|OG001|Outcome|Reference Product|Participants did not receive any product (mouthwash containing Chlorhexidine digluconate or toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
11218302|NCT02319668|EG000|Reported Event|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash).
11218303|NCT02319668|EG001|Reported Event|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
11218304|NCT02319759|BG000|Baseline|Placebo|Participants were randomized to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 and guselkumab 100 milligram (mg) subcutaneous injection at Weeks 24, 28, 36 and 44.
11218305|NCT02319759|BG001|Baseline|Guselkumab|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and placebo at Week 24, with a final follow-up at Week 56.
11218306|NCT02319759|BG002|Baseline|Total|Total of all reporting groups
11218307|NCT02319759|FG000|Participant Flow|Placebo (Week 0 to Week 24)|Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.
11218308|NCT02319759|FG001|Participant Flow|Placebo to Guselkumab (Week 24 to Week 56)|Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 received guselkumab 100 milligram (mg) subcutaneous injections at Weeks 24, 28, 36 and 44, with a final follow-up at Week 56.
11218309|NCT02319759|FG002|Participant Flow|Guselkumab (Week 0 to Week 56)|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and placebo at Week 24, with a final follow-up at Week 56.
11218310|NCT02319759|FG003|Participant Flow|Placebo to Ustekinumab (Week 16 to Week 56)|Participants who were randomized to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4 and 12, and had less than (<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 were qualified for early escape (EE) and switched to open-label ustekinumab subcutaneous injections at the approved dosage (45 mg or 90 mg) for psoriatic arthritis (PsA) in the particular country of the study at Weeks 16, 20, 32 and 44, with a final follow-up at Week 56.
11218311|NCT02319759|FG004|Participant Flow|Guselkumab to Ustekinumab (Week 16 to Week 56)|Participants who were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and had <5% improvement from baseline in both tender and swollen joint counts at Week 16 were qualified for EE and switched to open-label ustekinumab subcutaneous injections at the approved dosage (45 mg or 90 mg) for PsA in the particular country of the study at Weeks 16, 20, 32 and 44, with a final follow-up at Week 56.
11218312|NCT02319759|OG000|Outcome|Placebo|Participants were randomized at Week 0 to receive placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20.
11218313|NCT02319759|OG001|Outcome|Guselkumab|Participants were randomized at Week 0 to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12 and 20.
11218314|NCT02319759|OG000|Outcome|Placebo to Guselkumab (Week 24 to Week 56)|Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.
11218315|NCT02319759|OG001|Outcome|Guselkumab (Week 24 to Week 52)|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
11218316|NCT02319759|OG000|Outcome|Placebo to Guselkumab (CO) at Week 24|Participants who were randomized to receive placebo matched to guselkumab at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36 and 44.
11218317|NCT02319759|OG001|Outcome|Guselkumab|Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24.
11218318|NCT02319759|EG000|Reported Event|Placebo (Week 0 to Week 24)|Participants received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20. Data through Week 24 prior to receiving guselkumab or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included.
11218319|NCT02319759|EG001|Reported Event|Placebo to Guselkumab (Week 24 to Week 56)|Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injections at Week 24, 28, 36 and 44. Data from the first administration of guselkumab (Week 24) through Week 56 (final follow-up) were included.
11218320|NCT02319759|EG002|Reported Event|Guselkumab (Week 0 to Week 56)|Participants received guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24. Data from Week 0 through Week 56 (final follow-up) or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included.
11218321|NCT02319759|EG003|Reported Event|Placebo to Ustekinumab (EE: Week 16 to Week 56)|Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included.
11218322|NCT02319759|EG004|Reported Event|Guselkumab to Ustekinumab (EE:Week 16 to Week 56)|Participants who received guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included.
11218323|NCT02319824|BG000|Baseline|Treatment (Radiation and NY-ESO-1-specific T Cells)|"Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.~Autologous NY-ESO-1-specific CD8-positive T Lymphocytes"
11218324|NCT02319824|FG000|Participant Flow|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV 2-3 days after completion of radiation therapy.
11218325|NCT02319824|OG000|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
11218326|NCT02319824|OG000|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
11218327|NCT02319824|EG000|Reported Event|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
11218328|NCT02319967|BG000|Baseline|Enhanced Usual Care|Inhaler technique education and distribution of spacers to all participants.
11218329|NCT02319967|BG001|Baseline|ED-only|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge."
11218330|NCT02319967|BG002|Baseline|ED-plus-home|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~Community-health worker-led home visits.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.~Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation."
11218331|NCT02319967|BG003|Baseline|Total|Total of all reporting groups
11218332|NCT02319967|FG000|Participant Flow|Enhanced Usual Care|Inhaler technique education and distribution of spacers to all participants.
11218333|NCT02319967|FG001|Participant Flow|ED-only|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge."
11218334|NCT02319967|FG002|Participant Flow|ED-plus-home|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~Community-health worker-led home visits.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.~Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation."
11218335|NCT02319967|OG000|Outcome|Enhanced Usual Care|Inhaler technique education and distribution of spacers to all participants.
11218336|NCT02319967|OG001|Outcome|ED-only|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge."
11218337|NCT02319967|OG002|Outcome|ED-plus-home|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~Community-health worker-led home visits.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.~Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation."
11218338|NCT02319967|EG000|Reported Event|Usual Care|Inhaler technique education and distribution of spacers to all participants.
11218339|NCT02319967|EG001|Reported Event|CAPE|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge."
11218340|NCT02319967|EG002|Reported Event|CAPE + Home|"Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.~Community-health worker-led home visits.~CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.~Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation."
11218341|NCT02320058|BG000|Baseline|Cohort A|Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218342|NCT02320058|BG001|Baseline|Cohort B|Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218343|NCT02320058|BG002|Baseline|Total|Total of all reporting groups
11218344|NCT02320058|FG000|Participant Flow|Cohort A|Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218345|NCT02320058|FG001|Participant Flow|Cohort B|Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218346|NCT02320058|OG000|Outcome|Cohort A|Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218347|NCT02320058|OG001|Outcome|Cohort B|Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218348|NCT02320058|EG000|Reported Event|Cohort A|Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218349|NCT02320058|EG001|Reported Event|Cohort B|Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
11218350|NCT02320123|BG000|Baseline|Patients - Intervention|"For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218351|NCT02320123|BG001|Baseline|Patients - Control|"For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).~Usual Care"
11218352|NCT02320123|BG002|Baseline|Total|Total of all reporting groups
11218353|NCT02320123|FG000|Participant Flow|Patients - Intervention|"For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218354|NCT02320123|FG001|Participant Flow|Patients - Control|"For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).~Usual Care"
11218355|NCT02320123|OG000|Outcome|Patients - Intervention|"For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218356|NCT02320123|OG001|Outcome|Patients - Control|Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
11218357|NCT02320123|OG000|Outcome|Patients - Intervention|"For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218358|NCT02320123|OG001|Outcome|Patients - Control|"For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).~Usual Care"
11218359|NCT02320123|OG000|Outcome|Intervention Group|"For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218360|NCT02320123|OG001|Outcome|Control Group|"For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).~Usual Care"
11218361|NCT02320123|EG000|Reported Event|Patients - Intervention|"For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.~Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care."
11218362|NCT02320123|EG001|Reported Event|Patients - Control|"For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).~Usual Care"
11218363|NCT02320149|BG000|Baseline|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218364|NCT02320149|BG001|Baseline|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218365|NCT02320149|BG002|Baseline|Total|Total of all reporting groups
11218366|NCT02320149|FG000|Participant Flow|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218367|NCT02320149|FG001|Participant Flow|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218368|NCT02320149|OG000|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218369|NCT02320149|OG001|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218370|NCT02320149|EG000|Reported Event|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218371|NCT02320149|EG001|Reported Event|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218372|NCT02320175|BG000|Baseline|Pre-intervention|Before implementation of Patient and Family Centered I-PASS.
11218373|NCT02320175|BG001|Baseline|Post-intervention|After implementation of Patient and Family Centered I-PASS.
11218374|NCT02320175|BG002|Baseline|Total|Total of all reporting groups
11218375|NCT02320175|FG000|Participant Flow|Pre-intervention|Before implementation of Patient and Family Centered I-PASS.
11218376|NCT02320175|FG001|Participant Flow|Post-intervention|After implementation of Patient and Family Centered I-PASS.
11218377|NCT02320175|OG000|Outcome|Pre-intervention|Before implementation of Patient and Family Centered I-PASS.
11218378|NCT02320175|OG001|Outcome|Post-intervention|After implementation of Patient and Family Centered I-PASS.
11218379|NCT02320175|OG000|Outcome|Pre-intervention|Percent top-box score before implementation of Patient and Family Centered I-PASS.
11218380|NCT02320175|OG001|Outcome|Post-intervention|Percent top-box score after implementation of Patient and Family Centered I-PASS.
11218381|NCT02320175|OG001|Outcome|Post-intervention|"After implementation of Patient and Family Centered I-PASS.~Patient and Family Centered I-PASS: Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation."
11218382|NCT02320175|EG000|Reported Event|Pre-intervention|Before implementation of Patient and Family Centered I-PASS.
11218383|NCT02320175|EG001|Reported Event|Post-intervention|After implementation of Patient and Family Centered I-PASS.
11218384|NCT02320214|BG000|Baseline|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11218385|NCT02320214|FG000|Participant Flow|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11218386|NCT02320214|OG000|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11218387|NCT02320214|EG000|Reported Event|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11218388|NCT02320227|BG000|Baseline|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11218389|NCT02320227|FG000|Participant Flow|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11218390|NCT02320227|OG000|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
11218391|NCT02320227|OG000|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
11218392|NCT02320227|EG000|Reported Event|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11218393|NCT02320253|BG000|Baseline|Medical Nutrition Therapy (MNT)|"Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).~Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year."
11218394|NCT02320253|BG001|Baseline|In Person Group (IP)|"Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success."
11328455|NCT03427619|EG000|Reported Event|OK-432|"OK 432 is a lyophilized biological preparation for injection containing nonviable cells of Streptococcus pyogenes (A group, type 3) Su strain treated with benzylpenicillin.~OK-432 was administered intracystically at a concentration of 0.01 to 0.05 mg/mL. A 4-dose injection series of OK-432 was planned for all subjects. All injections were spaced approximately 6 to 12 weeks apart"
11218395|NCT02320253|BG002|Baseline|Telephone Conference Call Group (TCC)|"Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention."
11218396|NCT02320253|BG003|Baseline|Total|Total of all reporting groups
11218397|NCT02320253|FG000|Participant Flow|Medical Nutrition Therapy (MNT)|"Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).~Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year."
11218398|NCT02320253|FG001|Participant Flow|In Person Group (IP)|"Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success."
11218399|NCT02320253|FG002|Participant Flow|Telephone Conference Call Group (TCC)|"Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention."
11218400|NCT02320253|OG000|Outcome|Medical Nutrition Therapy (MNT)|"Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).~Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year."
11218401|NCT02320253|OG001|Outcome|In Person Group (IP)|"Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success."
11218402|NCT02320253|OG002|Outcome|Telephone Conference Call Group (TCC)|"Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention."
11218403|NCT02320253|EG000|Reported Event|Medical Nutrition Therapy (MNT)|"Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).~Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year."
11218404|NCT02320253|EG001|Reported Event|In Person Group (IP)|"Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success."
11218405|NCT02320253|EG002|Reported Event|Telephone Conference Call Group (TCC)|"Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.~Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention."
11218406|NCT02320487|BG000|Baseline|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
11218407|NCT02320487|FG000|Participant Flow|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
11218408|NCT02320487|OG000|Outcome|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
11218409|NCT02320487|EG000|Reported Event|Obinutuzumab + Bendamustine (BG)|Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
11218410|NCT02320695|BG000|Baseline|OVERALL|This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
11218411|NCT02320695|FG000|Participant Flow|OVERALL|Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
11218412|NCT02320695|OG000|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
11218413|NCT02320695|OG001|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
11218414|NCT02320695|OG002|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
11218415|NCT02320695|OG003|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
11218416|NCT02320695|OG004|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
11218417|NCT02320695|OG005|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
11218418|NCT02320695|EG000|Reported Event|OVERALL|This includes all 60 randomized subjects.
11218419|NCT02320721|BG000|Baseline|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218420|NCT02320721|BG001|Baseline|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218421|NCT02320721|BG002|Baseline|Total|Total of all reporting groups
11218422|NCT02320721|FG000|Participant Flow|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218423|NCT02320721|FG001|Participant Flow|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218424|NCT02320721|OG000|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218425|NCT02320721|OG001|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218426|NCT02320721|EG000|Reported Event|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218427|NCT02320721|EG001|Reported Event|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
11218428|NCT02320812|BG000|Baseline|Treated Subjects|"human retinal progenitor cells~human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)"
11328456|NCT03427892|BG000|Baseline|Brexpiprazole|"Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.~Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders."
11218429|NCT02320812|FG000|Participant Flow|Treated Subjects|"human retinal progenitor cells~human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)"
11218430|NCT02320812|OG000|Outcome|Treated Subjects|"human retinal progenitor cells~human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)"
11218431|NCT02320812|OG000|Outcome|0.5 Million Cells Cohort|subjects who received 0.5 million human retinal progenitor cells (hRPC)
11218432|NCT02320812|OG001|Outcome|1.0 Million Cells Cohort|subjects who received 1.0 million hRPC
11218433|NCT02320812|OG002|Outcome|2.0 Million Cells Cohort|subjects who received 2.0 million hRPC
11218434|NCT02320812|OG003|Outcome|3.0 Million Cells Cohort|subjects who received 3.0 million hRPC
11218435|NCT02320812|EG000|Reported Event|Treated Subjects|"human retinal progenitor cells~human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)"
11218436|NCT02320838|BG000|Baseline|All Participants|Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation
11218437|NCT02320838|FG000|Participant Flow|5 KHz First, Then TENS and Then Sham|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
11218438|NCT02320838|FG001|Participant Flow|TENS First, Then 5 KHz and Then Sham|"TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
11218439|NCT02320838|FG002|Participant Flow|Sham First, Then TENS and Then 5KHz|"Sham stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold."
11218440|NCT02320838|FG003|Participant Flow|TENS First, Then Sham and Then 5KHz|"ENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
11218441|NCT02320838|FG004|Participant Flow|5 KHz First, Then Sham and Then TENS|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.~Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
11218442|NCT02320838|OG000|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218443|NCT02320838|OG001|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218444|NCT02320838|OG002|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218445|NCT02320838|EG000|Reported Event|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold.~5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218446|NCT02320838|EG001|Reported Event|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds~TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218447|NCT02320838|EG002|Reported Event|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.~Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
11218448|NCT02320903|BG000|Baseline|Therapists|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218449|NCT02320903|BG001|Baseline|Parents/Caregivers|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218450|NCT02320903|BG002|Baseline|Youth/Teens|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218451|NCT02320903|BG003|Baseline|Total|Total of all reporting groups
11218452|NCT02320903|FG000|Participant Flow|Therapists|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218453|NCT02320903|FG001|Participant Flow|Parents/Caregivers|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218454|NCT02320903|FG002|Participant Flow|Youth/Teens|"In this study, all enrolled caregivers and teens will be referred to the study by their participating therapists. All caregiver/teen dyads will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218455|NCT02320903|OG000|Outcome|Parents/Caregivers|"All caregivers who used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218456|NCT02320903|OG000|Outcome|Parents/Caregivers|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218457|NCT02320903|OG000|Outcome|Parents/Caregivers|"In this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218458|NCT02320903|OG001|Outcome|Youth/Teens|"All caregiver/teen dyads used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.~VillageWhere App"
11218459|NCT02320903|OG000|Outcome|Parents/Caregivers Only|Parent/caregiver users of the linked parent-youth phone app system.
11218460|NCT02320903|OG000|Outcome|Youth/Teens Only|Youth/teens who used the app.
11218461|NCT02320903|EG000|Reported Event|Use of VillageWhere App Prototype|In this single-arm study design, all enrolled caregivers and teens used the VillageWhere App Prototype that was developed for this study. They were requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day. Thus, the risk was identical for both parents and teens, since both experienced the app as the only intervention (i.e., there was no comparison group who did not use the app).
11218462|NCT02321098|BG000|Baseline|Loceryl NL+Cosmetic Varnish|Loceryl NL+Cosmetic varnish once/week for 12 weeks
11218463|NCT02321098|BG001|Baseline|Loceryl NL 12 Weeks|Loceryl NL once/week for 12 weeks
11218464|NCT02321098|BG002|Baseline|Loceryl NL15 Months|Loceryl NL once/week for 15 months
11218465|NCT02321098|BG003|Baseline|Total|Total of all reporting groups
11218466|NCT02321098|FG000|Participant Flow|Loceryl NL+ Cosmetic Varnish|Loceryl NL + Cosmetic varnish once/week for 12 weeks
11218467|NCT02321098|FG001|Participant Flow|Loceryl NL 12 Weeks|Loceryl NL once/week for 12 weeks
11218468|NCT02321098|FG002|Participant Flow|Loceryl NL 15 Months|Loceryl NL once/week for additional 15 months
11218469|NCT02321098|OG000|Outcome|Loceryl NL+Cosmetic Varnish|Loceryl NL+Cosmetic varnish once/week for 12 weeks
11218470|NCT02321098|OG001|Outcome|Loceryl NL 12 Weeks|Loceryl NL once/week for 12 weeks
11218471|NCT02321098|OG000|Outcome|Loceryl NL+ Cosmetic Varnish + Loceryl NL|Once weekly application of Loceryl NL + Cosmetic varnish during 12 weeks followed by Loceryl NL once weekly applications for 15 additional months
11218472|NCT02321098|OG001|Outcome|Loceryl NL + Loceryl NL|Once weekly application of Loceryl NL alone during 12 weeks followed by Loceryl NL once weekly applications for 15 additional months
11218473|NCT02321098|EG000|Reported Event|Loceryl NL+Cosmetic Varnish|Loceryl NL+Cosmetic varnish once/week for 12 weeks
11218474|NCT02321098|EG001|Reported Event|Loceryl NL 12 Weeks|Loceryl NL alone once/week for 12 weeks
11218475|NCT02321098|EG002|Reported Event|Loceryl NL 15 Months|Loceryl NL once/week for additional 15 months
11218476|NCT02321111|BG000|Baseline|Lean Subjects|Ten lean subjects were randomized to receive 3 infusions in different order.
11218477|NCT02321111|FG000|Participant Flow|Eritoran/Lipid Then D5W/Saline Then D5W/Lipid|Subjects randomized to receive Eritoran/Lipid first then D5W/Saline then D5W/Lipid
11218478|NCT02321111|FG001|Participant Flow|D5W/Saline Then D5W/Lipid Then Eritoran/Lipid|Subjects randomized to receive D5W/Saline first then D5W/Lipid then Eritoran/Lipid
11218479|NCT02321111|FG002|Participant Flow|D5W/Lipid Then D5W/Saline Then Eritoran/Lipid|Subjects randomized to receive D5W/Lipid first then D5W/Saline then Eritoran/Lipid
11218480|NCT02321111|FG003|Participant Flow|D5W/Lipid Then Eritoran/Lipid Then D5W/Saline|Subjects randomized to receive first D5W/Lipid then Eritoran/Lipid then D5W/Saline
11218481|NCT02321111|FG004|Participant Flow|Eritoran/Lipid Then D5W/Lipid Then D5W/Saline|Subjects randomized to receive Eritoran/Lipid then D5W/Lipid then D5W/Saline
11218482|NCT02321111|FG005|Participant Flow|D5W/Saline Then Eritoran/Lipid Then D5W/Lipid|Subjects randomized to receive D5W/Saline then Eritoran/Lipid then D5W/Lipid
11218483|NCT02321111|OG000|Outcome|D5W (5% Dextrose in Water) + Saline|"IV administration of 5% Dextrose in water/D5W (vehicle) 12 mg every 12 hours plus Saline infusion at a rate of 30 mL/hour~D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle"
11218484|NCT02321111|OG001|Outcome|D5W (5% Dextrose in Water) + Intralipid|"IV Administration of 5% Dextrose in water /D5W (vehicle) 12 mg plus Intralipid infusion at a rate of 30 ml/hour~D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle"
11218485|NCT02321111|OG002|Outcome|Eritoran + Intralipid|"IV administration of Eritoran 12 mg every 12 hours plus Intralipid infusion at a rate of 30 ml/hour~Eritoran: Eritoran = E5564 Eritoran is a pharmacologic inhibitor of TLR4."
11218486|NCT02321111|EG000|Reported Event|D5W (5% Dextrose in Water) + Saline|"IV administration of 5% Dextrose in water/D5W (vehicle) 12 mg every 12 hours plus Saline infusion at a rate of 30 mL/hour~D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle"
11218487|NCT02321111|EG001|Reported Event|D5W (5% Dextrose in Water) + Intralipid|"IV Administration of 5% Dextrose in water /D5W (vehicle) 12 mg plus Intralipid infusion at a rate of 30 ml/hour~D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle"
11218488|NCT02321111|EG002|Reported Event|Eritoran + Intralipid|"IV administration of Eritoran 12 mg every 12 hours plus Intralipid infusion at a rate of 30 ml/hour~Eritoran: Eritoran = E5564 Eritoran is a pharmacologic inhibitor of TLR4."
11218489|NCT02321319|BG000|Baseline|Hydromorphone HCl ER Tablets|Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
11218490|NCT02321319|FG000|Participant Flow|Hydromorphone HCl ER Tablets|Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
11218491|NCT02321319|OG000|Outcome|Hydromorphone HCl ER Tablets|Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
11218492|NCT02321319|EG000|Reported Event|Hydromorphone HCl ER Tablets|Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
11218493|NCT02321436|BG000|Baseline|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
11218494|NCT02321436|BG001|Baseline|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
11218495|NCT02321436|BG002|Baseline|Total Title|
11218496|NCT02321436|FG000|Participant Flow|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL).~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
11218497|NCT02321436|FG001|Participant Flow|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
11218498|NCT02321436|OG000|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
11218499|NCT02321436|OG001|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
11218500|NCT02321436|OG000|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
11218501|NCT02321436|EG000|Reported Event|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.~Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
11218502|NCT02321436|EG001|Reported Event|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
11218503|NCT02321462|BG000|Baseline|Eziclen|Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
11218504|NCT02321462|BG001|Baseline|Fortrans®|Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
11218505|NCT02321462|BG002|Baseline|Total Title|
11218506|NCT02321462|FG000|Participant Flow|Eziclen|Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
11218507|NCT02321462|FG001|Participant Flow|Fortrans®|Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
11218508|NCT02321462|OG000|Outcome|Eziclen|Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
11218509|NCT02321462|OG001|Outcome|Fortrans®|Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
11218510|NCT02321462|OG001|Outcome|Fortrans®|Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2 at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
11218511|NCT02321462|EG000|Reported Event|Eziclen|Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
11218512|NCT02321462|EG001|Reported Event|Fortrans®|Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
11218513|NCT02321527|BG000|Baseline|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
11218514|NCT02321527|FG000|Participant Flow|CEUS SNL Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.
11218515|NCT02321527|OG000|Outcome|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
11218516|NCT02321527|EG000|Reported Event|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
11218517|NCT02321748|BG000|Baseline|Montelukast, Then Montelukast + ASP2151|"10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151~Montelukast~ASP2151"
11218518|NCT02321748|BG001|Baseline|Montelukast + ASP2151, Then Montelukast|"10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone~Montelukast~ASP2151"
11218519|NCT02321748|BG002|Baseline|Total|Total of all reporting groups
11218520|NCT02321748|FG000|Participant Flow|Montelukast, Then Montelukast + ASP2151|"10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151~Montelukast~ASP2151"
11218521|NCT02321748|FG001|Participant Flow|Montelukast + ASP2151, Then Montelukast|"10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone~Montelukast~ASP2151"
11218522|NCT02321748|OG000|Outcome|Montelukast|"10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151~Montelukast~ASP2151"
11218523|NCT02321748|OG001|Outcome|ASP2151|"10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone~Montelukast~ASP2151"
11218524|NCT02321748|OG000|Outcome|Montelukast Alone|Participants received montelukast 10 mg alone in first or second intervation
11218525|NCT02321748|OG001|Outcome|Montelukast With ASP2151|Participants received montelukast 10 mg with ASP2151 400mg in first or second intervation
11218526|NCT02321748|OG000|Outcome|ASP2151|"10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone~Montelukast~ASP2151"
11218527|NCT02321748|EG000|Reported Event|Montelukast|Participants received montelukast 10 mg alone in first or second intervention
11218528|NCT02321748|EG001|Reported Event|ASP2151|Participants received montelukast 10 mg with ASP2151 400mg in first or second intervention
11218529|NCT02321800|BG000|Baseline|Cefiderocol|Participants received 2 g cefiderocol by intravenous injection once every 8 hours for 7 to 14 days.
11218530|NCT02321800|BG001|Baseline|Imipenem/Cilastatin|Participants received 1 g each of imipenem/cilastatin by intravenous injection once every 8 hours for 7 to 14 days.
11218531|NCT02321800|BG002|Baseline|Total|Total of all reporting groups
11218532|NCT02321800|FG000|Participant Flow|Cefiderocol|Participants received 2 g cefiderocol by intravenous injection once every 8 hours for 7 to 14 days.
11218533|NCT02321800|FG001|Participant Flow|Imipenem/Cilastatin|Participants received 1 g each of imipenem/cilastatin by intravenous injection once every 8 hours for 7 to 14 days.
11218534|NCT02321800|OG000|Outcome|Cefiderocol|Participants received 2 g cefiderocol by intravenous injection once every 8 hours for 7 to 14 days.
11218535|NCT02321800|OG001|Outcome|Imipenem/Cilastatin|Participants received 1 g each of imipenem/cilastatin by intravenous injection once every 8 hours for 7 to 14 days.
11218536|NCT02321800|EG000|Reported Event|S-649266|
11218537|NCT02321800|EG001|Reported Event|Imipenem/Cilastatin|
11218538|NCT02321930|BG000|Baseline|Tofacitinib 5mg po Bid|"All subjects will receive tofacitinib.~Tofacitinib: Subjects will receive tofacitinib 5mg po bid"
11218539|NCT02321930|FG000|Participant Flow|Tofacitinib 5mg po Bid|"All subjects will receive tofacitinib.~Tofacitinib: Subjects will receive tofacitinib 5mg po bid"
11218540|NCT02321930|OG000|Outcome|Tofacitinib 5mg po Bid|"One arm only. All subjects will receive tofacitinib.~Tofacitinib: Subjects will receive tofacitinib 5mg po bid"
11218541|NCT02321930|EG000|Reported Event|Tofacitinib 5mg po Bid|"All subjects will receive tofacitinib.~Tofacitinib: Subjects will receive tofacitinib 5mg po bid"
11218542|NCT02322021|BG000|Baseline|Core Phase: Placebo|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
11218543|NCT02322021|BG001|Baseline|Core Phase: Elenbecestat 5 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218544|NCT02322021|BG002|Baseline|Core Phase: Elenbecestat 15 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218545|NCT02322021|BG003|Baseline|Core Phase: Elenbecestat 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218546|NCT02322021|BG004|Baseline|Total|Total of all reporting groups
11218547|NCT02322021|FG000|Participant Flow|Core Phase: Placebo|Participants with mild cognitive impairment due to alzheimer's disease (AD)/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
11218548|NCT02322021|FG001|Participant Flow|Core Phase: Elenbecestat 5 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 milligram (mg) tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11328457|NCT03427892|FG000|Participant Flow|Brexpiprazole|"Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.~Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders."
11218549|NCT02322021|FG002|Participant Flow|Core Phase: Elenbecestat 15 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218550|NCT02322021|FG003|Participant Flow|Core Phase: Elenbecestat 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218551|NCT02322021|FG004|Participant Flow|Extension Phase: Elenbecestat 50 mg|Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
11218552|NCT02322021|OG000|Outcome|Core Phase: Placebo|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
11218553|NCT02322021|OG001|Outcome|Core Phase: Elenbecestat 5 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218554|NCT02322021|OG002|Outcome|Core Phase: Elenbecestat 15 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218555|NCT02322021|OG003|Outcome|Core Phase: Elenbecestat 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218556|NCT02322021|OG000|Outcome|Extension Phase: Elenbecestat 50 mg|Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
11218557|NCT02322021|OG000|Outcome|Core Phase: Elenbecestat 5 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218558|NCT02322021|OG001|Outcome|Core Phase: Elenbecestat 15 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218559|NCT02322021|OG002|Outcome|Core Phase: Elenbecestat 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218560|NCT02322021|EG000|Reported Event|Core Phase: Placebo|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
11328458|NCT03427892|OG000|Outcome|Brexpiprazole|"Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.~Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders."
11218561|NCT02322021|EG001|Reported Event|Core Phase: Elenbecestat 5 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218562|NCT02322021|EG002|Reported Event|Core Phase: Elenbecestat 15 mg Then 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11218563|NCT02322021|EG003|Reported Event|Core Phase: Elenbecestat 50 mg|Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
11328459|NCT03427892|EG000|Reported Event|Brexpiprazole|"Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.~Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders."
11328460|NCT03427931|BG000|Baseline|Continuous Glucose Monitor (CGM)|"Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.~Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months."
11328461|NCT03427931|FG000|Participant Flow|Continuous Glucose Monitor (CGM)|"Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.~Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months."
11328462|NCT03427931|OG000|Outcome|Continuous Glucose Monitor (CGM)|"Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.~Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months."
11328463|NCT03427931|EG000|Reported Event|Continuous Glucose Monitor (CGM)|"Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.~Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months."
11328464|NCT03428152|BG000|Baseline|Hypo|"The participants with a superior hypogastric block~superior hypogastric block: superior hypogastric blockade during surgery"
11328465|NCT03428152|BG001|Baseline|NoHypo|The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
11328466|NCT03428152|BG002|Baseline|Total|Total of all reporting groups
11328467|NCT03428152|FG000|Participant Flow|Hypo|"The participants with a superior hypogastric block~superior hypogastric block: superior hypogastric blockade during surgery"
11328468|NCT03428152|FG001|Participant Flow|NoHypo|The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
11328469|NCT03428152|OG000|Outcome|Hypo|"The participants with a superior hypogastric block~superior hypogastric block: superior hypogastric blockade during surgery"
11328470|NCT03428152|OG001|Outcome|NoHypo|The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
11328471|NCT03428152|EG000|Reported Event|Hypo|"The participants with a superior hypogastric block~superior hypogastric block: superior hypogastric blockade during surgery"
11328472|NCT03428152|EG001|Reported Event|NoHypo|The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
11328473|NCT03428230|BG000|Baseline|30 mg Paracetamol 3% (1 mL)|"30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT)~30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11218564|NCT02322021|EG004|Reported Event|Extension Phase: Elenbecestat 50 mg|Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
11218565|NCT02322047|BG000|Baseline|Praz/Nal|"Prazosin and Naltrexone.~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM"
11218566|NCT02322047|BG001|Baseline|Praz/Pl|"Prazosin and Placebo (Naltrexone)~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218567|NCT02322047|BG002|Baseline|Nal/Pl|"Naltrexone and Placebo (Prazosin)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM"
11218568|NCT02322047|BG003|Baseline|Pl/Pl|"Placebo (Prazosin) and Placebo (Naltrexone)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218569|NCT02322047|BG004|Baseline|Total|Total of all reporting groups
11218570|NCT02322047|FG000|Participant Flow|Praz/Nal|"Prazosin and Naltrexone.~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM"
11218571|NCT02322047|FG001|Participant Flow|Praz/Pl|"Prazosin and Placebo (Naltrexone)~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218572|NCT02322047|FG002|Participant Flow|Nal/Pl|"Naltrexone and Placebo (Prazosin)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM"
11218573|NCT02322047|FG003|Participant Flow|Pl/Pl|"Placebo (Prazosin) and Placebo (Naltrexone)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218574|NCT02322047|OG000|Outcome|Praz/Nal|"Prazosin and Naltrexone.~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM"
11336200|NCT03563027|FG002|Participant Flow|Social Incentive Gamification and Financial Incentive|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game~Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met"
11218575|NCT02322047|OG001|Outcome|Praz/Pl|"Prazosin and Placebo (Naltrexone)~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218576|NCT02322047|OG002|Outcome|Nal/Pl|"Naltrexone and Placebo (Prazosin)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM"
11218577|NCT02322047|OG003|Outcome|Pl/Pl|"Placebo (Prazosin) and Placebo (Naltrexone)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218578|NCT02322047|EG000|Reported Event|Praz/Nal|"Prazosin and Naltrexone.~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM"
11218579|NCT02322047|EG001|Reported Event|Praz/Pl|"Prazosin and Placebo (Naltrexone)~Prazosin will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218580|NCT02322047|EG002|Reported Event|Nal/Pl|"Naltrexone and Placebo (Prazosin)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM"
11218581|NCT02322047|EG003|Reported Event|Pl/Pl|"Placebo (Prazosin) and Placebo (Naltrexone)~Prazosin Placebo will be taken following this titration schedule:~Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.~Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM~Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM"
11218582|NCT02322125|BG000|Baseline|ReWalk Training|ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
11218583|NCT02322125|FG000|Participant Flow|ReWalk Training|ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
11336201|NCT03563027|OG000|Outcome|Control|This arm serves as control and uses a wearable device to track daily step counts
11218584|NCT02322125|OG000|Outcome|ReWalk Training|ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
11218585|NCT02322125|EG000|Reported Event|ReWalk Training|"ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.~ReWalk: Intensive training with the ReWalk to negotiate smooth ground, rough terrain indoors and outdoors, ascending and descending slopes and steps, in a home setting and in the community."
11218586|NCT02322190|BG000|Baseline|Investigator Chosen Second Line Therapy|Investigator chosen second line therapy is determined on an individual basis based on standard care and actual site of Graft -versus-Host Disease (GVHD). The frequency or duration of therapy is based on Principal Investigator (PI) discretion.
11218587|NCT02322190|FG000|Participant Flow|Investigator Chosen Second Line Therapy|Investigator chosen second line therapy is determined on an individual basis based on standard care and actual site of Graft -versus-Host Disease (GVHD). The frequency or duration of therapy is based on Principal Investigator (PI) discretion.
11218588|NCT02322190|FG001|Participant Flow|Second Line Therapy + Extracorporeal Photopheresis|"Second line therapy in addition to Extracorporeal Photopheresis (ECP)~Extracorporeal Photopheresis (ECP): Twice weekly for 1 month or Twice every other week for 2 months or Twice during one week per month for 4 months for a total of up to 7 months of treatment~Methoxsalen: Used in conjunction with photopheresis procedure"
11218589|NCT02322190|OG000|Outcome|Investigator Chosen Second Line Therapy|Investigator chosen second line therapy is determined on an individual basis based on standard care and actual site of Graft -versus-Host Disease (GVHD). The frequency or duration of therapy is based on Principal Investigator (PI) discretion.
11218590|NCT02322190|EG000|Reported Event|Investigator Chosen Second Line Therapy|Investigator chosen second line therapy is determined on an individual basis based on standard care and actual site of Graft -versus-Host Disease (GVHD). The frequency or duration of therapy is based on Principal Investigator (PI) discretion.
11218591|NCT02322190|EG001|Reported Event|Second Line Therapy + Extracorporeal Photopheresis|"Second line therapy in addition to Extracorporeal Photopheresis (ECP)~Extracorporeal Photopheresis (ECP): Twice weekly for 1 month or Twice every other week for 2 months or Twice during one week per month for 4 months for a total of up to 7 months of treatment~Methoxsalen: Used in conjunction with photopheresis procedure"
11218592|NCT02322216|BG000|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
11218593|NCT02322216|BG001|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
11218594|NCT02322216|BG002|Baseline|Total|Total of all reporting groups
11218595|NCT02322216|FG000|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
11218596|NCT02322216|FG001|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
11218597|NCT02322216|OG000|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
11218598|NCT02322216|OG001|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
11218599|NCT02322216|EG000|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11218600|NCT02322216|EG001|Reported Event|PATADAY|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%
11218601|NCT02322216|EG002|Reported Event|PATANOL|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%
11218602|NCT02322229|BG000|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection
11218603|NCT02322229|FG000|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
11218604|NCT02322229|OG000|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection
11218605|NCT02322229|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11218606|NCT02322229|EG001|Reported Event|Jetrea|Subjects exposed to Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection
11218607|NCT02322242|BG000|Baseline|Perineural Dexamethasone|"ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)~Perineural dexamethasone: Perinerual administration of dexamethasone (4mg)"
11218608|NCT02322242|BG001|Baseline|Systemic Dexamethasone|"ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)~Systemic Dexamethasone: Intravenous infusion of dexamethasone (4mg)"
11218609|NCT02322242|BG002|Baseline|Total|Total of all reporting groups
11218610|NCT02322242|FG000|Participant Flow|Perineural Dexamethasone|ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
11218611|NCT02322242|FG001|Participant Flow|Systemic Dexamethasone|ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
11218612|NCT02322242|OG000|Outcome|Perineural Dexamethasone|ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
11218613|NCT02322242|OG001|Outcome|Systemic Dexamethasone|ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
11218614|NCT02322242|EG000|Reported Event|Perineural Dexamethasone|"ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)~Perineural dexamethasone: Perinerual administration of dexamethasone (4mg)"
11218615|NCT02322242|EG001|Reported Event|Systemic Dexamethasone|"ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)~Systemic Dexamethasone: Intravenous infusion of dexamethasone (4mg)"
11218616|NCT02322281|BG000|Baseline|Rociletinib 500 mg BID|Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218617|NCT02322281|BG001|Baseline|Rociletinib 625 mg BID|Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218618|NCT02322281|BG002|Baseline|Chemotherapy|"Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.~Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.~Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.~or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Treatment duration until radiographically confirmed disease progression."
11218619|NCT02322281|BG003|Baseline|Total|Total of all reporting groups
11218620|NCT02322281|FG000|Participant Flow|Rociletinib 500 mg BID|Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218621|NCT02322281|FG001|Participant Flow|Rociletinib 625 mg BID|Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218622|NCT02322281|FG002|Participant Flow|Chemotherapy|"Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.~Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.~Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.~or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Treatment duration until radiographically confirmed disease progression."
11218623|NCT02322281|OG000|Outcome|Rociletinib 500 mg BID|Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218624|NCT02322281|OG001|Outcome|Rociletinib 625 mg BID|Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218625|NCT02322281|OG002|Outcome|Chemotherapy|"Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.~Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.~Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.~or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Treatment duration until radiographically confirmed disease progression."
11218626|NCT02322281|EG000|Reported Event|Rociletinib 500 mg BID|Starting dose of 500 mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218627|NCT02322281|EG001|Reported Event|Rociletinib 625 mg BID|Starting dose of 625 mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218628|NCT02322281|EG002|Reported Event|Chemotherapy|"Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.~Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.~Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.~or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.~Treatment duration until radiographically confirmed disease progression."
11218629|NCT02322281|EG003|Reported Event|Crossover From Chemotherapy to Rociletinib 500 mg BID|Patients initially randomized to comparator chemotherapy had the option to cross over to rociletinib following disease progression per RECIST Version 1.1. Rociletinib starting dose of 500 mg taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
11218630|NCT02322281|EG004|Reported Event|Crossover From Chemotherapy to Rociletinib 625 mg BID|Patients initially randomized to comparator chemotherapy had the option to cross over to rociletinib following disease progression per RECIST Version 1.1. Rociletinib starting dose of 625 mg taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression
11218631|NCT02322320|BG000|Baseline|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218632|NCT02322320|BG001|Baseline|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218633|NCT02322320|BG002|Baseline|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218634|NCT02322320|BG003|Baseline|Total|Total of all reporting groups
11218635|NCT02322320|FG000|Participant Flow|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218636|NCT02322320|FG001|Participant Flow|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218637|NCT02322320|FG002|Participant Flow|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218638|NCT02322320|OG000|Outcome|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218639|NCT02322320|OG001|Outcome|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218640|NCT02322320|OG002|Outcome|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218641|NCT02322320|EG000|Reported Event|Tandem Auto Transplant|"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218642|NCT02322320|EG001|Reported Event|RVD Consolidation|"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218643|NCT02322320|EG002|Reported Event|Lenalidomide Maintenance|"Initial autologous transplant followed by lenalidomide maintenance~Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study."
11218644|NCT02322333|BG000|Baseline|MLD10|All study participants randomized to MLD10 arm
11218645|NCT02322333|BG001|Baseline|Placebo|All study participants randomized to Placebo arm
11218646|NCT02322333|BG002|Baseline|Total|Total of all reporting groups
11218647|NCT02322333|FG000|Participant Flow|MLD10|"Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.~MLD10"
11218648|NCT02322333|FG001|Participant Flow|Placebo|"Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.~Placebo"
11218649|NCT02322333|OG000|Outcome|MLD10|"Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.~MLD10"
11218650|NCT02322333|OG001|Outcome|Placebo|"Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.~Placebo"
11218651|NCT02322333|EG000|Reported Event|MLD10|All subjects randomized to MLD10 arm
11218652|NCT02322333|EG001|Reported Event|Placebo|All subjects randomized to Placebo arm
11218653|NCT02322411|BG000|Baseline|Compensatory|"This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation.~Compensatory approaches"
11218654|NCT02322411|BG001|Baseline|I-PRO + Compensatory|"The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks.~Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.~Compensatory approaches"
11218655|NCT02322411|BG002|Baseline|Total|Total of all reporting groups
11218656|NCT02322411|FG000|Participant Flow|Compensatory|"This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation.~Compensatory approaches"
11218657|NCT02322411|FG001|Participant Flow|I-PRO + Compensatory|"The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks.~Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.~Compensatory approaches"
11218658|NCT02322411|OG000|Outcome|Compensatory|"This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation.~Compensatory approaches"
11218659|NCT02322411|OG001|Outcome|I-PRO + Compensatory|"The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks.~Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.~Compensatory approaches"
11218660|NCT02322411|EG000|Reported Event|Compensatory|"This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation.~Compensatory approaches"
11218661|NCT02322411|EG001|Reported Event|I-PRO + Compensatory|"The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks.~Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.~Compensatory approaches"
11218662|NCT02322528|BG000|Baseline|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
11218663|NCT02322528|FG000|Participant Flow|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
11218664|NCT02322528|OG000|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
11218665|NCT02322528|EG000|Reported Event|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
11218666|NCT02322749|BG000|Baseline|Overall Study|All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
11218667|NCT02322749|FG000|Participant Flow|Sequence ABC|Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218668|NCT02322749|FG001|Participant Flow|Sequence ACB|Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218669|NCT02322749|FG002|Participant Flow|Sequence BAC|Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218670|NCT02322749|FG003|Participant Flow|Sequence BCA|Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218671|NCT02322749|FG004|Participant Flow|Sequence CAB|Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218672|NCT02322749|FG005|Participant Flow|Sequence CBA|Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
11218673|NCT02322749|OG000|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218674|NCT02322749|OG001|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218675|NCT02322749|OG001|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218676|NCT02322749|OG002|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218677|NCT02322749|EG000|Reported Event|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218678|NCT02322749|EG001|Reported Event|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218679|NCT02322749|EG002|Reported Event|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
11218680|NCT02322775|BG000|Baseline|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
11218681|NCT02322775|BG001|Baseline|Placebo|Placebo administered subcutaneously every 4 weeks
11218682|NCT02322775|BG002|Baseline|Total|Total of all reporting groups
11218683|NCT02322775|FG000|Participant Flow|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
11218684|NCT02322775|FG001|Participant Flow|Placebo|Placebo administered subcutaneously every 4 weeks
11218685|NCT02322775|OG000|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
11218686|NCT02322775|OG001|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
11218687|NCT02322775|EG000|Reported Event|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
11218688|NCT02322775|EG001|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks
11218689|NCT02322788|BG000|Baseline|Overall|Total number of participants in the Full analysis set
11218690|NCT02322788|FG000|Participant Flow|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
11218691|NCT02322788|FG001|Participant Flow|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
11218692|NCT02322788|FG002|Participant Flow|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
11218693|NCT02322788|FG003|Participant Flow|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
11218694|NCT02322788|OG000|Outcome|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
11218695|NCT02322788|OG001|Outcome|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
11218696|NCT02322788|OG002|Outcome|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
11218697|NCT02322788|OG003|Outcome|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
11218698|NCT02322788|EG000|Reported Event|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
11218699|NCT02322788|EG001|Reported Event|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
11218700|NCT02322788|EG002|Reported Event|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
11218701|NCT02322788|EG003|Reported Event|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
11218702|NCT02322814|BG000|Baseline|Cohort I: Safety Run-In|Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).
11218703|NCT02322814|BG001|Baseline|Cohort I: Placebo, Paclitaxel|Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218704|NCT02322814|BG002|Baseline|Cohort I: Cobimetinib, Paclitaxel|Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218705|NCT02322814|BG003|Baseline|Cohort II:Cobimetinib,Paclitaxel,Atezolizumab|Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218706|NCT02322814|BG004|Baseline|Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab|Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218707|NCT02322814|BG005|Baseline|Total|Total of all reporting groups
11218708|NCT02322814|FG000|Participant Flow|Cohort I: Safety Run-In|Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).
11218709|NCT02322814|FG001|Participant Flow|Cohort I: Placebo, Paclitaxel|Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218710|NCT02322814|FG002|Participant Flow|Cohort I: Cobimetinib, Paclitaxel|Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218711|NCT02322814|FG003|Participant Flow|Cohort II:Cobimetinib,Paclitaxel,Atezolizumab|Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218712|NCT02322814|FG004|Participant Flow|Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab|Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218713|NCT02322814|OG000|Outcome|Cohort I: Cobimetinib, Paclitaxel|Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218714|NCT02322814|OG001|Outcome|Cohort I: Placebo, Paclitaxel|Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218715|NCT02322814|OG000|Outcome|Cohort II:Cobimetinib,Paclitaxel,Atezolizumab|Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218716|NCT02322814|OG001|Outcome|Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab|Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218717|NCT02322814|EG000|Reported Event|Cohort I: Safety Run-In|Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).
11218718|NCT02322814|EG001|Reported Event|Cohort I: Placebo, Paclitaxel|Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218719|NCT02322814|EG002|Reported Event|Cohort I: Cobimetinib, Paclitaxel|Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218720|NCT02322814|EG003|Reported Event|Cohort II:Cobimetinib,Paclitaxel,Atezolizumab|Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218721|NCT02322814|EG004|Reported Event|Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab|Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
11218722|NCT02322866|BG000|Baseline|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218723|NCT02322866|BG001|Baseline|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218724|NCT02322866|BG002|Baseline|Total|Total of all reporting groups
11218725|NCT02322866|FG000|Participant Flow|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218726|NCT02322866|FG001|Participant Flow|Sarecycline|Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
11218727|NCT02322866|OG000|Outcome|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218728|NCT02322866|OG001|Outcome|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11218729|NCT02322866|EG000|Reported Event|Placebo|Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
11218730|NCT02322866|EG001|Reported Event|Sarecycline|Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
11328474|NCT03428230|BG001|Baseline|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)~60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328475|NCT03428230|BG002|Baseline|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT)~90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328476|NCT03428230|BG003|Baseline|Placebo, 0.9% Saline Solution|"Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT)~Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328477|NCT03428230|BG004|Baseline|Total|Total of all reporting groups
11328478|NCT03428230|FG000|Participant Flow|30 mg Paracetamol 3% (1 mL)|"30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT)~30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11336202|NCT03563027|OG001|Outcome|Social Incentive Gamification|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game"
11218731|NCT02322879|BG000|Baseline|Acetaminophen First, Then Acetaminophen + Propylene Glycol|"Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks."
11218732|NCT02322879|BG001|Baseline|Acetaminophen + Propylene Glycol First, Then Acetaminophen|"Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation for two weeks."
11218733|NCT02322879|BG002|Baseline|Total|Total of all reporting groups
11218734|NCT02322879|FG000|Participant Flow|Acetaminophen First, Then Acetaminophen + Propylene Glycol|"Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks."
11218735|NCT02322879|FG001|Participant Flow|Acetaminophen + Propylene Glycol First, Then Acetaminophen|"Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.~Then, subjects received 4 grams of solid acetaminophen formulation for two weeks."
11218736|NCT02322879|OG000|Outcome|Acetaminophen|Participants received 4 grams of solid acetaminophen formulation for two weeks
11218737|NCT02322879|OG001|Outcome|Acetaminophen + Propylene Glycol|Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks
11218738|NCT02322879|EG000|Reported Event|Acetaminophen|Participants received 4 grams of solid acetaminophen formulation for two weeks.
11218739|NCT02322879|EG001|Reported Event|Acetaminophen + Propylene Glycol|Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks.
11218740|NCT02322892|BG000|Baseline|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218741|NCT02322892|BG001|Baseline|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218742|NCT02322892|BG002|Baseline|Total|Total of all reporting groups
11218743|NCT02322892|FG000|Participant Flow|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218744|NCT02322892|FG001|Participant Flow|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218745|NCT02322892|OG000|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218746|NCT02322892|OG001|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218747|NCT02322892|EG000|Reported Event|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218748|NCT02322892|EG001|Reported Event|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
11218749|NCT02323048|BG000|Baseline|Paired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218750|NCT02323048|BG001|Baseline|Paired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218751|NCT02323048|BG002|Baseline|Paired, no Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218752|NCT02323048|BG003|Baseline|Unpaired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218753|NCT02323048|BG004|Baseline|Unpaired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218754|NCT02323048|BG005|Baseline|Total|Total of all reporting groups
11218755|NCT02323048|FG000|Participant Flow|Paired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)~placebo: Placebo (sugar pill)"
11218756|NCT02323048|FG001|Participant Flow|Paired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218757|NCT02323048|FG002|Participant Flow|Paired, no Reward|"All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218758|NCT02323048|FG003|Participant Flow|Unpaired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218759|NCT02323048|FG004|Participant Flow|Unpaired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218760|NCT02323048|OG000|Outcome|Paired, High Reward (Methamphetamine Sessions)|All subjects received methamphetamine (20 mg) on two conditioning sessions
11218761|NCT02323048|OG001|Outcome|Paired, Low Reward (Methamphetamine Sessions)|All subjects received methamphetamine (20 mg) on two conditioning sessions
11218762|NCT02323048|OG002|Outcome|Paired no Reward (Methamphetamine Sessions)|All subjects received methamphetamine (20 mg) on two conditioning sessions
11218763|NCT02323048|OG003|Outcome|Unpaired, High Reward (Methamphetamine Sessions)|All subjects received methamphetamine (20 mg) on two conditioning sessions
11218764|NCT02323048|OG004|Outcome|Unpaired, Low Reward (Methamphetamine Sessions)|All subjects received methamphetamine (20 mg) on two conditioning sessions
11218765|NCT02323048|EG000|Reported Event|Paired, No Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218766|NCT02323048|EG001|Reported Event|Paired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218767|NCT02323048|EG002|Reported Event|Paired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218768|NCT02323048|EG003|Reported Event|Unpaired, Low Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218769|NCT02323048|EG004|Reported Event|Unpaired, High Reward|"All participants will be administered methamphetamine (20mg) and placebo.~methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.~placebo: Placebo (sugar pill)"
11218770|NCT02323113|BG000|Baseline|TAK-659 60 mg QD|TAK-659, 60 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218771|NCT02323113|BG001|Baseline|TAK-659 100 mg QD|TAK-659, 100 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218772|NCT02323113|BG002|Baseline|TAK-659 120 mg QD|TAK-659, 120 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218773|NCT02323113|BG003|Baseline|TAK-659 140 mg QD|TAK-659, 140 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218774|NCT02323113|BG004|Baseline|TAK-659 160 mg QD|TAK-659, 160 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218775|NCT02323113|BG005|Baseline|TAK-659 60 mg BID|TAK-659, 60 mg, tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218776|NCT02323113|BG006|Baseline|TAK-659 80 mg BID|TAK-659, 80 mg tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218777|NCT02323113|BG007|Baseline|Total|Total of all reporting groups
11218778|NCT02323113|FG000|Participant Flow|TAK-659 60 mg QD|TAK-659, 60 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218779|NCT02323113|FG001|Participant Flow|TAK-659 100 mg QD|TAK-659, 100 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218780|NCT02323113|FG002|Participant Flow|TAK-659 120 mg QD|TAK-659, 120 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218781|NCT02323113|FG003|Participant Flow|TAK-659 140 mg QD|TAK-659, 140 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218782|NCT02323113|FG004|Participant Flow|TAK-659 160 mg QD|TAK-659, 160 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218783|NCT02323113|FG005|Participant Flow|TAK-659 60 mg BID|TAK-659, 60 mg, tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218784|NCT02323113|FG006|Participant Flow|TAK-659 80 mg BID|TAK-659, 80 mg tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218785|NCT02323113|FG007|Participant Flow|Phase 2 (Dose Expansion Phase)|TAK-659 tablets at the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D) determined from dose escalation phase, orally, QD or BID on Days 1 to 28 in each 28-day Cycle, for up to 12 cycles or until disease progression in participants who were to be entered in Phase 2.
11218786|NCT02323113|OG000|Outcome|TAK-659 60 mg QD|TAK-659, 60 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218787|NCT02323113|OG001|Outcome|TAK-659 100 mg QD|TAK-659, 100 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218788|NCT02323113|OG002|Outcome|TAK-659 120 mg QD|TAK-659, 120 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218789|NCT02323113|OG003|Outcome|TAK-659 140 mg QD|TAK-659, 140 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218790|NCT02323113|OG004|Outcome|TAK-659 160 mg QD|TAK-659, 160 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218791|NCT02323113|OG005|Outcome|TAK-659 60 mg BID|TAK-659, 60 mg, tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218792|NCT02323113|OG006|Outcome|TAK-659 80 mg BID|TAK-659, 80 mg tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218793|NCT02323113|OG000|Outcome|Phase 2 (Dose Expansion Phase)|TAK-659 tablets at the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D) determined from dose escalation phase, orally, QD or BID on Days 1 to 28 in each 28-day Cycle, for up to 12 cycles or until disease progression in participants who were to be entered in Phase 2.
11218794|NCT02323113|OG000|Outcome|TAK-659 60 mg BID|TAK-659, 60 mg, tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218795|NCT02323113|OG001|Outcome|TAK-659 80 mg BID|TAK-659, 80 mg tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218796|NCT02323113|EG000|Reported Event|TAK-659 60 mg QD|TAK-659, 60 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218797|NCT02323113|EG001|Reported Event|TAK-659 100 mg QD|TAK-659, 100 mg tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218798|NCT02323113|EG002|Reported Event|TAK-659 120 mg QD|TAK-659, 120 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218799|NCT02323113|EG003|Reported Event|TAK-659 140 mg QD|TAK-659, 140 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218800|NCT02323113|EG004|Reported Event|TAK-659 160 mg QD|TAK-659, 160 mg, tablets, orally, QD on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218801|NCT02323113|EG005|Reported Event|TAK-659 60 mg BID|TAK-659, 60 mg, tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218802|NCT02323113|EG006|Reported Event|TAK-659 80 mg BID|TAK-659, 80 mg tablets, orally, BID on Days 1 to 28 in each 28-day Cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 12 cycles.
11218803|NCT02323204|BG000|Baseline|Link: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218804|NCT02323204|BG001|Baseline|Link: Parent Participants|"Participants of this group completed a baseline questionnaire and received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218805|NCT02323204|BG002|Baseline|Trauma Education: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received the trauma education booklet, So you've been in an accident."
11218806|NCT02323204|BG003|Baseline|Trauma Education: Parent Participants|"Participants of this group completed a baseline questionnaire and received the trauma education booklet, So you've been in an accident."
11218807|NCT02323204|BG004|Baseline|Total|Total of all reporting groups
11218808|NCT02323204|FG000|Participant Flow|Link: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218809|NCT02323204|FG001|Participant Flow|Link: Parent Participants|"Participants of this group completed a baseline questionnaire and received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218810|NCT02323204|FG002|Participant Flow|Trauma Education: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received the trauma education booklet, So you've been in an accident."
11218811|NCT02323204|FG003|Participant Flow|Trauma Education: Parent Participants|"Participants of this group completed a baseline questionnaire and received the trauma education booklet, So you've been in an accident."
11218812|NCT02323204|OG000|Outcome|Link: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218813|NCT02323204|OG001|Outcome|Link: Parent Participants|"Participants of this group completed a baseline questionnaire and received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218814|NCT02323204|OG002|Outcome|Trauma Education: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received the trauma education booklet, So you've been in an accident."
11218815|NCT02323204|OG003|Outcome|Trauma Education: Parent Participants|"Participants of this group completed a baseline questionnaire and received the trauma education booklet, So you've been in an accident."
11218816|NCT02323204|EG000|Reported Event|Link: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218817|NCT02323204|EG001|Reported Event|Link: Parent Participants|"Participants of this group completed a baseline questionnaire and received Link for Injured Kids: Psychological First Aid, an in-person training in key intervention communication skills from a trained interventionist."
11218818|NCT02323204|EG002|Reported Event|Trauma Education: Child Participants|"Participants of this group were injured children who completed a baseline questionnaire and whose parents received the trauma education booklet, So you've been in an accident."
11218819|NCT02323204|EG003|Reported Event|Trauma Education: Parent Participants|"Participants of this group completed a baseline questionnaire and received the trauma education booklet, So you've been in an accident."
11218820|NCT02323217|BG000|Baseline|Healthy Volunteers|"[11C]BU99008: Baseline Scan, Test-ReTest or Dosimetry~Idazoxan: Idazoxan block of [11C]BU99008~Isocarboxazid: Isocarboxazid block of [11C]BU99008"
11218821|NCT02323217|FG000|Participant Flow|Healthy Volunteers|"[11C]BU99008: Baseline Scan, Test-ReTest or Dosimetry~Idazoxan: Idazoxan block of [11C]BU99008~Isocarboxazid: Isocarboxazid block of [11C]BU99008"
11218822|NCT02323217|OG000|Outcome|Healthy Volunteers|"[11C]BU99008: Baseline Scan, Test-ReTest or Dosimetry~Idazoxan: Idazoxan block of [11C]BU99008~Isocarboxazid: Isocarboxazid block of [11C]BU99008"
11218823|NCT02323217|EG000|Reported Event|Healthy Volunteers|"[11C]BU99008: Baseline Scan, Test-ReTest or Dosimetry~Idazoxan: Idazoxan block of [11C]BU99008~Isocarboxazid: Isocarboxazid block of [11C]BU99008"
11218824|NCT02323334|BG000|Baseline|Part A Cohort 1|Escalating single dose given orally (PO)per randomly assigned treatment sequence of 0.1mg, 1.6mg, 15mg LY3202626 or placebo.
11218825|NCT02323334|BG001|Baseline|Part A Cohort 2|"Escalating single dose given PO per randomly assigned treatment sequence of 0.4mg, 5mg, or 45mg LY3202626, placebo.~Some participants may also receive multiple doses of 200 mg of Itraconazole PO in 1 period with 0.4mg of LY3202626."
11218826|NCT02323334|BG002|Baseline|Part A Food Effect Cohort 3|Single dose of 10mg LY3202626 given PO in Period 1 and Period 2 only.
11218827|NCT02323334|BG003|Baseline|Part B Cohort 4|Single oral dose of 1.6mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A.
11218828|NCT02323334|BG004|Baseline|Part B Cohort 5|Single oral dose of 10mg LY3202626 or placebo given PO in in Period 1. Dose determined by Part A.
11218829|NCT02323334|BG005|Baseline|Part B Cohort 6|Single oral dose of 26mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A.
11218830|NCT02323334|BG006|Baseline|Part C Cohort 7|Multiple oral doses of 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
11218831|NCT02323334|BG007|Baseline|Part C Cohort 8|Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
11218832|NCT02323334|BG008|Baseline|Part C Cohort 9|Multiple oral doses of 26mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
11218833|NCT02323334|BG009|Baseline|Part D Cohort 10|Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
11218834|NCT02323334|BG010|Baseline|Total|Total of all reporting groups
11218835|NCT02323334|FG000|Participant Flow|Part A Cohort 1 Sequence 1: 0.1mg, 1.6mg, Placebo (PBO); 15mg|"Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.~Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg PBO Period 4: 15mg LY3202626"
11218836|NCT02323334|FG001|Participant Flow|Part A Cohort 1 Sequence 2: 1.6mg, PBO,15mg, 15mg|"Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.~Period 1: 1.6mg LY3202626 Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626"
11218837|NCT02323334|FG002|Participant Flow|Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, PBO|"Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.~Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO"
11218838|NCT02323334|FG003|Participant Flow|Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO; 0.4mg/200mg Itra|"Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole (Itra). There was a washout period of approximately 14 days between doses.~Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg PBO Period 4: 0.4mg LY3202626/200mg Itraconazole"
11218839|NCT02323334|FG004|Participant Flow|Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/200mg Itra|"Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole.There was a washout period of approximately 14 days between doses.~Period 1: 0.4mg LY3202626 Period 2: 5mg PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole"
11218840|NCT02323334|FG005|Participant Flow|Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra|"Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole. There was a washout period of approximately 14 days between doses.~Period 1: 0.4mg PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole"
11218841|NCT02323334|FG006|Participant Flow|Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted|"Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose of 10mg LY3202626 given PO in Period 1 and 2. There was a washout period of approximately 14 days between doses.~Period 1: Fed Period 2: Fasted"
11218842|NCT02323334|FG007|Participant Flow|Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed|"Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose 10mg LY3202626 given PO in Period 1 and 2.~There was a washout period of approximately 14 days between doses.~Period 1: Fasted Period 2: Fed"
11218843|NCT02323334|FG008|Participant Flow|Part B Cohort 4: 1.6mg|Part B Cohort 4 involved healthy participants and was comprised of one period. Single dose of 1.6mg LY3202626 given PO in Period 1. Dose determined by Part A.
11218844|NCT02323334|FG009|Participant Flow|Part B Cohort 5: 10mg|Part B Cohort 5 involved healthy participants and was comprised of one period. Single dose of 10mg LY3202626 given PO in Period 1. Dose determined by Part A.
11218845|NCT02323334|FG010|Participant Flow|Part B Cohort 6: 26mg|Part B Cohort 6 involved healthy participants and was comprised of one period. Single dose of 26mg LY3202626 given PO in Period 1. Dose determined by Part A.
11218846|NCT02323334|FG011|Participant Flow|Part B Cohort 4, 5, 6: PBO Comparator|Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1.
11218847|NCT02323334|FG012|Participant Flow|Part C Cohort 7: 1mg|Part C Cohort 7 involved healthy participants and was comprised of one period. 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
11218848|NCT02323334|FG013|Participant Flow|Part C Cohort 8: 6mg|Part C Cohort 8 involved healthy participants and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.
11218849|NCT02323334|FG014|Participant Flow|Part C Cohort 9: 26mg|Part C Cohort 9 included healthy participants and was comprised of one period. 26mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.
11218850|NCT02323334|FG015|Participant Flow|Part C Cohort 7, 8 ,9: PBO Comparator|Part C Cohort 7, 8, 9 involved healthy participants and was comprised of one period. PBO given PO once daily for 14 days.
11218851|NCT02323334|FG016|Participant Flow|Part D Cohort 10: 6mg|Part D Cohort 10 involved participants with Alzheimer's disease and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.
11218852|NCT02323334|OG000|Outcome|Part A, B, and C Placebo (PBO)|Single dose placebo given PO in Part A and B. Multiple doses of PBO given PO in Part C.
11218853|NCT02323334|OG001|Outcome|Part A 0.1mg LY3202626|Single dose of 0.1mg LY3202626 given PO Period 1 Cohort 1.
11218854|NCT02323334|OG002|Outcome|Part A 0.4mg LY3202626|Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
11218855|NCT02323334|OG003|Outcome|Part A 0.4mg LY3202626 + 200mg Itraconazole|Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in Period 4 Cohort 2.
11218856|NCT02323334|OG004|Outcome|Part C 1mg LY3202626 QD|Multiple daily dose of 1mg LY3202626 given PO once daily for 14 days.
11218857|NCT02323334|OG005|Outcome|Part A and B 1.6mg LY3202626|Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1 in Part A and Period 1 Part B.
11218858|NCT02323334|OG006|Outcome|Part A 5mg LY3202626|Single dose of 5mg LY3202626 given PO in in Period 2 Cohort 2.
11218859|NCT02323334|OG007|Outcome|Part C and D 6mg LY3202626 QD|Multiple daily dose of 6mg LY3202626 given PO once daily for 14 days.
11218860|NCT02323334|OG008|Outcome|Part A, B and C 10mg LY3202626|Single dose of 10mg LY3202626 given PO in Part A and B. Multiple dose of 10mg LY3202626 given PO in Part C once daily for 14 days.
11218861|NCT02323334|OG009|Outcome|Part A 15mg LY3202626|Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1.
11218862|NCT02323334|OG010|Outcome|Part B and C 26mg LY3202626|Single dose of 26mg LY3202626 given PO in Period 1 in Part B. Multiple daily dose of 26mg LY3202626 given PO once daily for 14 days in Part C.
11218863|NCT02323334|OG011|Outcome|Part A 45mg LY3202626|Single dose of 45mg LY3202626 given PO in in Period 3 Cohort 2.
11218864|NCT02323334|OG000|Outcome|Part A 0.1mg LY3202626|Single dose of 0.1mg LY3202626 given PO in Period 1 Cohort 1.
11218865|NCT02323334|OG001|Outcome|Part A 0.4mg LY3202626|Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
11218866|NCT02323334|OG002|Outcome|Part A 1.6mg LY3202626|Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1.
11218867|NCT02323334|OG003|Outcome|Part A 5mg LY3202626|Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2.
11218868|NCT02323334|OG004|Outcome|Part A 15mg LY3202626|Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1.
11218869|NCT02323334|OG005|Outcome|Part A 45mg LY3202626|Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2.
11218870|NCT02323334|OG006|Outcome|Part B 1.6mg LY3202626|Single dose of 1.6mg LY3202626 given PO Period 1.
11218871|NCT02323334|OG007|Outcome|Part B 10mg LY3202626|Single dose of 10mg LY3202626 given PO in Period 1.
11218872|NCT02323334|OG008|Outcome|Part B 26mg LY3202626|Single dose of 26mg LY3202626 given PO in Period1.
11218873|NCT02323334|OG009|Outcome|Part C 1mg LY3202626 QD|Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
11218874|NCT02323334|OG010|Outcome|Part C 6mg LY3202626 QD|Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
11218875|NCT02323334|OG011|Outcome|Part C 26mg LY3202626 QD|Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
11218876|NCT02323334|OG006|Outcome|Part B 1.6mg LY3202626|Single dose of 1.6mg LY3202626 given PO in Period 1.
11218877|NCT02323334|OG008|Outcome|Part B 26mg LY3202626|Single dose of 26mg LY3202626 given PO in Period 1.
11218878|NCT02323334|OG009|Outcome|Part C 1mg LY3202626 QD|Multiple doses of 1mg LY3202626 given PO once daily for 14 days..
11218879|NCT02323334|OG000|Outcome|Part A Placebo|Single dose of placebo given PO in capsule form in Period 1-4.
11218880|NCT02323334|OG001|Outcome|Part A 0.1mg LY3202626|Single dose 0.1mg LY3202626 given PO in Period 1 Cohort 1.
11218881|NCT02323334|OG003|Outcome|Part A 1.6 mg LY3202626|Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1.
11218882|NCT02323334|OG004|Outcome|Part A 5mg LY3202626|Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2.
11218883|NCT02323334|OG005|Outcome|Part A 15mg LY3202626|Single dose of 15mg LY3202626 given PO in Period 3 and Period 4 Cohort 1.
11218884|NCT02323334|OG006|Outcome|Part A 45mg LY3202626|Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2.
11218885|NCT02323334|OG007|Outcome|Part C Placebo|Multiple doses of placebo given PO once daily for 14 days.
11218886|NCT02323334|OG008|Outcome|Part C 1mg LY3202626 QD|Multiple doses of 1mg LY3202626 in given PO once daily for 14 days.
11218887|NCT02323334|OG009|Outcome|Part C 6mg LY3202626 QD|Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
11218888|NCT02323334|OG010|Outcome|Part C 26mg LY3202626 QD|Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
11218889|NCT02323334|OG000|Outcome|Part B Placebo|Single dose of placebo given PO in Period 1.
11218890|NCT02323334|OG001|Outcome|Part B 1.6 mg LY3202626|Single dose of 1.6mg LY3202626 given PO in Period 1.
11218891|NCT02323334|OG002|Outcome|Part B 6mg LY3202626|Single dose of 6mg LY3202626 given PO in Period 1.
11218892|NCT02323334|OG003|Outcome|Part B 26mg LY3202626|Single dose of 26mg LY3202626 given PO in Period 1.
11218893|NCT02323334|OG000|Outcome|Part C 1mg LY3202626|Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
11218894|NCT02323334|OG001|Outcome|Part C 6 mg LY3202626|Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
11218895|NCT02323334|OG002|Outcome|Part C 26mg LY3202626|Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
11218896|NCT02323334|OG000|Outcome|Part C Placebo|Multiple doses of placebo given PO once daily for 14 days.
11218897|NCT02323334|OG001|Outcome|Part C 1mg LY3202626|Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
11218898|NCT02323334|OG002|Outcome|Part C 6mg LY3202626|Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
11218899|NCT02323334|OG003|Outcome|Part C 26mg LY3202626|Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
11218900|NCT02323334|EG000|Reported Event|Part A, B, and C Placebo|Single dose of placebo given PO in in capsule form, Part A and B. Multiple doses of placebo given PO in capsule form, Part C.
11218901|NCT02323334|EG001|Reported Event|Part A 0.1mg LY3202626|Single dose of 0.1mg LY3202626 given PO in in capsule form.
11218902|NCT02323334|EG002|Reported Event|Part A 0.4mg LY3202626|Single dose of 0.4mg LY3202626 given PO in in capsule form.
11218903|NCT02323334|EG003|Reported Event|Part A 0.4mg LY3202626 + 200mg Itraconazole|Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in in capsule form.
11218904|NCT02323334|EG004|Reported Event|Part C 1mg LY3202626 QD|Multiple daily dose of 1mg LY3202626 given PO in in capsule form.
11218905|NCT02323334|EG005|Reported Event|Part A and B 1.6mg LY3202626|Single dose of 1.6mg LY3202626 given PO in in capsule form..
11218906|NCT02323334|EG006|Reported Event|Part A 5mg LY3202626|Single dose of 5mg LY3202626 given PO in in capsule form.
11218907|NCT02323334|EG007|Reported Event|Part C and Part D 6mg LY3202626 QD|Multiple daily dose of 6mg LY3202626 given PO in capsule form.
11218908|NCT02323334|EG008|Reported Event|Part A and B 10mg LY3202626|Single dose of 10mg LY3202626 given PO in capsule form.
11218909|NCT02323334|EG009|Reported Event|Part A 15mg LY3202626|Single dose of 15mg LY3202626 given PO in capsule form.
11218910|NCT02323334|EG010|Reported Event|Part B and C 26mg LY3202626|Single dose of 26mg LY3202626 given PO in capsule form, Part B. Multiple daily dose of 26mg LY3202626 in in capsule form, Part C.
11218911|NCT02323334|EG011|Reported Event|Part A 45mg LY3202626|Single dose of 45mg LY3202626 given PO in in capsule form.
11218912|NCT02323646|BG000|Baseline|Placebo|Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218913|NCT02323646|BG001|Baseline|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218914|NCT02323646|BG002|Baseline|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218915|NCT02323646|BG003|Baseline|Total|Total of all reporting groups
11218916|NCT02323646|FG000|Participant Flow|Placebo|Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218917|NCT02323646|FG001|Participant Flow|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218918|NCT02323646|FG002|Participant Flow|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218919|NCT02323646|OG000|Outcome|Placebo|Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218920|NCT02323646|OG001|Outcome|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218921|NCT02323646|OG002|Outcome|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218922|NCT02323646|EG000|Reported Event|Placebo|Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218923|NCT02323646|EG001|Reported Event|Telapristone Acetate 6 mg|Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218924|NCT02323646|EG002|Reported Event|Telapristone Acetate 12 mg|Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
11218925|NCT02323854|BG000|Baseline|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
11218926|NCT02323854|FG000|Participant Flow|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data was collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
11218927|NCT02323854|OG000|Outcome|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
11218928|NCT02323854|EG000|Reported Event|Ablation and Surgical Resection|"All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.~Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.~Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit."
11218929|NCT02324049|BG000|Baseline|SBC-103|"Part A (Initial therapy): Participants received SBC-103, 0.3, 1.0, or 3.0 mg/kg QOW for 24 weeks, followed by a ≥ 4-week treatment break. Participants enrolled in the lowest dosage first.~Part B: Participants were escalated to the next highest dose that was considered safe (1.0 or 3.0 mg/kg QOW) for ≥ 8 weeks. Participants who received doses of 0.3 mg/kg in Part A were considered for a second dose escalation to 3.0 mg/kg at any time during Part B provided that they tolerated at least 2 doses of 1.0 mg/kg in Part B. Participants who received and tolerated at least 4 doses of SBC-103 QOW at 3.0 mg/kg were considered for participation in Part C.~Part C: Participants received SBC-103 5.0 or 10.0 mg/kg administered IV QOW. Dosing in Part C began at the 5.0 mg/kg dose level. The decision to begin dosing the first participant at 10.0 mg/kg was based on the review of safety data at 5.0 mg/kg."
11218930|NCT02324049|FG000|Participant Flow|SBC-103|"Part A (Initial therapy): Participants received SBC-103, 0.3, 1.0, or 3.0 milligrams (mg) per kilogram (kg) every other week (QOW) for 24 weeks, followed by a ≥ 4-week treatment break. Participants enrolled in the lowest dosage first.~Part B: Participants were escalated to the next highest dose that was considered safe (1.0 or 3.0 mg/kg QOW) for ≥ 8 weeks. Participants who received doses of 0.3 mg/kg in Part A were considered for a second dose escalation to 3.0 mg/kg at any time during Part B provided that they tolerated at least 2 doses of 1.0 mg/kg in Part B. Participants who received and tolerated at least 4 doses of SBC-103 QOW at 3.0 mg/kg were considered for participation in Part C.~Part C: Participants received SBC-103 5.0 or 10.0 mg/kg administered intravenous (IV) QOW. Dosing in Part C began at the 5.0 mg/kg dose level. The decision to begin dosing the first participant at 10.0 mg/kg was based on the review of safety data at 5.0 mg/kg."
11218931|NCT02324049|OG000|Outcome|SBC-103|"Part A (Initial therapy): Participants received SBC-103, 0.3, 1.0, or 3.0 mg/kg QOW for 24 weeks, followed by a ≥ 4-week treatment break. Participants enrolled in the lowest dosage first.~Part B: Participants were escalated to the next highest dose that was considered safe (1.0 or 3.0 mg/kg QOW) for ≥ 8 weeks. Participants who received doses of 0.3 mg/kg in Part A were considered for a second dose escalation to 3.0 mg/kg at any time during Part B provided that they tolerated at least 2 doses of 1.0 mg/kg in Part B. Participants who received and tolerated at least 4 doses of SBC-103 QOW at 3.0 mg/kg were considered for participation in Part C.~Part C: Participants received SBC-103 5.0 or 10.0 mg/kg administered IV QOW. Dosing in Part C began at the 5.0 mg/kg dose level. The decision to begin dosing the first participant at 10.0 mg/kg was based on the review of safety data at 5.0 mg/kg."
11218932|NCT02324049|EG000|Reported Event|SBC-103|"Part A (Initial therapy): Participants received SBC-103, 0.3, 1.0, or 3.0 mg/kg QOW for 24 weeks, followed by a ≥ 4-week treatment break. Participants enrolled in the lowest dosage first.~Part B: Participants were escalated to the next highest dose that was considered safe (1.0 or 3.0 mg/kg QOW) for ≥ 8 weeks. Participants who received doses of 0.3 mg/kg in Part A were considered for a second dose escalation to 3.0 mg/kg at any time during Part B provided that they tolerated at least 2 doses of 1.0 mg/kg in Part B. Participants who received and tolerated at least 4 doses of SBC-103 QOW at 3.0 mg/kg were considered for participation in Part C.~Part C: Participants received SBC-103 5.0 or 10.0 mg/kg administered IV QOW. Dosing in Part C began at the 5.0 mg/kg dose level. The decision to begin dosing the first participant at 10.0 mg/kg was based on the review of safety data at 5.0 mg/kg."
11218933|NCT02324075|BG000|Baseline|Behavior Change|"Behavior change messaging with facilitating hardware~Behavior change: Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket"
11218934|NCT02324075|BG001|Baseline|Control Arm|Standard habits and practices
11218935|NCT02324075|BG002|Baseline|Total|Total of all reporting groups
11218936|NCT02324075|FG000|Participant Flow|Behavior Change|"Behavior change messaging with facilitating hardware~Behavior change: Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket"
11218937|NCT02324075|FG001|Participant Flow|Control Arm|Standard habits and practices
11218938|NCT02324075|OG000|Outcome|Behavior Change|"Behavior change messaging with facilitating hardware~Behavior change: Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket"
11218939|NCT02324075|OG001|Outcome|Control Arm|Standard habits and practices
11218940|NCT02324075|OG000|Outcome|Behavior Change|"Behavior change messaging with facilitating hardware.~Behavior change: Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket."
11218941|NCT02324075|EG000|Reported Event|Behavior Change|"Behavior change messaging with facilitating hardware~Behavior change: Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket"
11218942|NCT02324075|EG001|Reported Event|Control Arm|Standard habits and practices
11218943|NCT02324153|BG000|Baseline|Treatment|"Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)~Ramelteon: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218944|NCT02324153|BG001|Baseline|Placebo|"Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218945|NCT02324153|BG002|Baseline|Total|Total of all reporting groups
11218946|NCT02324153|FG000|Participant Flow|Treatment|"Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)~Ramelteon: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218947|NCT02324153|FG001|Participant Flow|Placebo|"Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218948|NCT02324153|OG000|Outcome|Treatment|"Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)~Ramelteon: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218949|NCT02324153|OG001|Outcome|Placebo|"Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218950|NCT02324153|EG000|Reported Event|Treatment|"Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)~Ramelteon: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218951|NCT02324153|EG001|Reported Event|Placebo|"Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)~Microcrystalline Cellulose: Placebo Comparator~Riboflavin 100 mg: Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)"
11218952|NCT02324205|BG000|Baseline|DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.~DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM."
11218953|NCT02324205|FG000|Participant Flow|DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.~DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM."
11218954|NCT02324205|OG000|Outcome|DBT and FFDM|"Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.~Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded."
11218955|NCT02324205|EG000|Reported Event|DBT and FFDM|"Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.~DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM."
11218956|NCT02324270|BG000|Baseline|Diclofenac Epolamine Patch (Test Product)|"Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218957|NCT02324270|BG001|Baseline|Flector (Reference Product)|"Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218958|NCT02324270|BG002|Baseline|Placebo|"Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine~Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218959|NCT02324270|BG003|Baseline|Total|Total of all reporting groups
11218960|NCT02324270|FG000|Participant Flow|Diclofenac Epolamine Patch (Test Product)|"Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218961|NCT02324270|FG001|Participant Flow|Flector (Reference Product)|"Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218962|NCT02324270|FG002|Participant Flow|Placebo|"Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine~Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218963|NCT02324270|OG000|Outcome|Diclofenac Epolamine Patch (Test Product)|"Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218964|NCT02324270|OG001|Outcome|Flector (Reference Product)|"Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218965|NCT02324270|OG002|Outcome|Placebo|"Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine~Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218966|NCT02324270|EG000|Reported Event|Diclofenac Epolamine Patch (Test Product)|"Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218967|NCT02324270|EG001|Reported Event|Flector (Reference Product)|"Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)~Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218968|NCT02324270|EG002|Reported Event|Placebo|"Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine~Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain"
11218969|NCT02324335|BG000|Baseline|Placebo Oral Rinse|"Water for Injection~Placebo: Oral Rinse used 3 times daily for 7 weeks"
11218970|NCT02324335|BG001|Baseline|Active Oral Rinse|"Brilacidin 3 mg/mL in Water for Injection~Brilacidin: Oral Rinse used 3 times daily for 7 weeks"
11218971|NCT02324335|BG002|Baseline|Total|Total of all reporting groups
11218972|NCT02324335|FG000|Participant Flow|Placebo Oral Rinse|"Water for Injection~Placebo: Oral Rinse used 3 times daily for 7 weeks"
11218973|NCT02324335|FG001|Participant Flow|Active Oral Rinse|"Brilacidin 3 mg/mL in Water for Injection~Brilacidin: Oral Rinse used 3 times daily for 7 weeks"
11218974|NCT02324335|OG000|Outcome|Placebo Oral Rinse|"Water for Injection~Placebo: Oral Rinse used 3 times daily for 7 weeks"
11218975|NCT02324335|OG001|Outcome|Active Oral Rinse|"Brilacidin 3 mg/mL in Water for Injection~Brilacidin: Oral Rinse used 3 times daily for 7 weeks"
11218976|NCT02324335|EG000|Reported Event|Placebo Oral Rinse|"Water for Injection~Placebo: Oral Rinse used 3 times daily for 7 weeks"
11218977|NCT02324335|EG001|Reported Event|Active Oral Rinse|"Brilacidin 3 mg/mL in Water for Injection~Brilacidin: Oral Rinse used 3 times daily for 7 weeks"
11218978|NCT02324361|BG000|Baseline|Facebook Group|"The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group.~Participating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study.~All index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study."
11218979|NCT02324361|BG001|Baseline|Text Messaging|"The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.~The automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on."
11218980|NCT02324361|BG002|Baseline|Total|Total of all reporting groups
11218981|NCT02324361|FG000|Participant Flow|Facebook Group|"The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11218982|NCT02324361|FG001|Participant Flow|Text Messaging (SMS) Group|"The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.~The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11218983|NCT02324361|OG000|Outcome|Facebook Group|"The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11336203|NCT03563027|OG002|Outcome|Social Incentive Gamification and Financial Incentive|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game~Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met"
11218984|NCT02324361|OG001|Outcome|Text Messaging (SMS) Group|"The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.~The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11218985|NCT02324361|EG000|Reported Event|Facebook Group|"The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11218986|NCT02324361|EG001|Reported Event|Text Messaging (SMS) Group|"The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages.~The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on.~All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study."
11218987|NCT02324465|BG000|Baseline|King Vision Video Laryngoscope|"The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218988|NCT02324465|BG001|Baseline|Glidescope Video Laryngoscope|"The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218989|NCT02324465|BG002|Baseline|Total|Total of all reporting groups
11218990|NCT02324465|FG000|Participant Flow|King Vision Video Laryngoscope|"The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218991|NCT02324465|FG001|Participant Flow|Glidescope Video Laryngoscope|"The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218992|NCT02324465|OG000|Outcome|King Vision Video Laryngoscope|"The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope"
11218993|NCT02324465|OG001|Outcome|Glidescope Video Laryngoscope|"The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218994|NCT02324465|EG000|Reported Event|King Vision Video Laryngoscope|"The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL~King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope"
11218995|NCT02324465|EG001|Reported Event|Glidescope Video Laryngoscope|"The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL~Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope"
11218996|NCT02324504|BG000|Baseline|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.~Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement."
11218997|NCT02324504|FG000|Participant Flow|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement. Standard care chest radiograph will be performed as a second measure to confirm catheter tip placement."
11218998|NCT02324504|OG000|Outcome|Total Enrolllment|All subjects (less than 18 years of age) will have PICC placement guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
11218999|NCT02324504|OG001|Outcome|Subjects Age 0-2 Years of Age|Approximately 38% of the enrolled subjects were two years of age or younger. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
11219000|NCT02324504|OG002|Outcome|Subjects Age 3-11 Years of Age|Approximately 23% of the enrolled subjects were between the ages of 3 and 11 years. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
11219001|NCT02324504|OG003|Outcome|Subjects Age 12-17 Years of Age|Approximately 38% of the enrolled subjects were between 12 and 17 years of age. In all three groups PICC placement will be guided by the C3 Wave device in order to determine if success rates, overall and by age group, are greater than local historical success rates.
11336204|NCT03563027|EG000|Reported Event|Control|This arm serves as control and uses a wearable device to track daily step counts
10843222|NCT00252629|FG002|Participant Flow|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
10843223|NCT00252629|OG000|Outcome|Therapeutic Nasal CPAP|Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
10843224|NCT00252629|OG001|Outcome|Sham Nasal CPAP|Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
10843225|NCT00252629|OG000|Outcome|Therapeutic Nasal CPAP|Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
10843226|NCT00252629|OG001|Outcome|Sham Nasal CPAP|Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
10843227|NCT00252629|OG000|Outcome|Therapeutic Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
10843228|NCT00252629|OG001|Outcome|Sham Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
10843229|NCT00252629|OG000|Outcome|GWS Male Group|"A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
10843230|NCT00252629|OG001|Outcome|Asymptomatic Male Veterans of Gulf War.|"A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
10843231|NCT00252629|EG000|Reported Event|Therapeutic Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP
10843232|NCT00252629|EG001|Reported Event|Sham Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP
10843233|NCT00252629|EG002|Reported Event|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
10843234|NCT00252694|BG000|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
10843235|NCT00252694|BG001|Baseline|Placebo|Placebo Comparator
10843236|NCT00252694|BG002|Baseline|Total|Total of all reporting groups
10843237|NCT00252694|FG000|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
10843238|NCT00252694|FG001|Participant Flow|Placebo|Placebo Comparator
10843239|NCT00252694|OG000|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
10843240|NCT00252694|OG001|Outcome|Placebo|Placebo Comparator
10843241|NCT00252694|EG000|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
10843242|NCT00252694|EG001|Reported Event|Placebo|Placebo Comparator
10843243|NCT00252720|BG000|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
10843244|NCT00252720|BG001|Baseline|Placebo|Placebo Comparator
10843245|NCT00252720|BG002|Baseline|Total|Total of all reporting groups
10843246|NCT00252720|FG000|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
10843247|NCT00252720|FG001|Participant Flow|Placebo|Placebo Comparator
10843248|NCT00252720|OG000|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
10843249|NCT00252720|OG001|Outcome|Placebo|Placebo Comparator
10843250|NCT00252720|EG000|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
10843251|NCT00252720|EG001|Reported Event|Placebo|Placebo Comparator
10843252|NCT00252733|BG000|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
10843253|NCT00252733|BG001|Baseline|Placebo|Placebo Comparator
10843254|NCT00252733|BG002|Baseline|Total|Total of all reporting groups
10843255|NCT00252733|FG000|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
10843256|NCT00252733|FG001|Participant Flow|Placebo|Placebo Comparator
10843257|NCT00252733|OG000|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
10843258|NCT00252733|OG001|Outcome|Placebo|Placebo Comparator
10843259|NCT00252733|EG000|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
10843260|NCT00252733|EG001|Reported Event|Placebo|Placebo Comparator
10843261|NCT00252967|BG000|Baseline|Placebo|
10843262|NCT00252967|BG001|Baseline|Atorvastatin|
10843263|NCT00252967|BG002|Baseline|Total|Total of all reporting groups
10843264|NCT00252967|FG000|Participant Flow|Placebo|
10843265|NCT00252967|FG001|Participant Flow|Atorvastatin|
10843266|NCT00252967|OG000|Outcome|Placebo|
10843267|NCT00252967|OG001|Outcome|Atorvastatin|
11219002|NCT02324504|EG000|Reported Event|Intervention|"Subjects will have their central catheters placed with the assistance of the FDA approved C3 Wave PICC Tip Confirmation System which will assist with location of the catheter tip in real-time, during the procedure.~C3 Wave ECG-based PICC Tip Confirmation System: The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.~Chest radiograph: Chest radiograph will be performed as a second measure to confirm catheter tip placement."
11219003|NCT02324543|BG000|Baseline|Dose Level 1 - Phase 1|"Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219004|NCT02324543|BG001|Baseline|Dose Level 1a - Phase 1|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219005|NCT02324543|BG002|Baseline|Dose Level 1b - Phase 1|"Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219006|NCT02324543|BG003|Baseline|Dose Level 2 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219007|NCT02324543|BG004|Baseline|Dose Level 3 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219008|NCT02324543|BG005|Baseline|Phase 2|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219009|NCT02324543|BG006|Baseline|Total|Total of all reporting groups
11219010|NCT02324543|FG000|Participant Flow|Dose Level 1- Phase 1|"Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219011|NCT02324543|FG001|Participant Flow|Dose Level 1a - Phase 1|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219012|NCT02324543|FG002|Participant Flow|Dose Level 1b - Phase 1|"Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219013|NCT02324543|FG003|Participant Flow|Dose Level 2 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219014|NCT02324543|FG004|Participant Flow|Dose Level 3 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219015|NCT02324543|FG005|Participant Flow|Phase 2|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
10843268|NCT00252967|EG000|Reported Event|Placebo|
10843269|NCT00252967|EG001|Reported Event|Atorvastatin|
10843270|NCT00253019|BG000|Baseline|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
10843271|NCT00253019|BG001|Baseline|Depo Provera|Participants self-selected to receive Depo Provera
10843272|NCT00253019|BG002|Baseline|Ortho Evra|Participants self-selected to receive Ortho Evra.
10843273|NCT00253019|BG003|Baseline|Total|Total of all reporting groups
10843274|NCT00253019|FG000|Participant Flow|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
10843275|NCT00253019|FG001|Participant Flow|Depo Provera|Participants self-selected to receive Depo Provera
10843276|NCT00253019|FG002|Participant Flow|Ortho Evra|Participants self-selected to receive Ortho Evra.
10843277|NCT00253019|OG000|Outcome|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
10843278|NCT00253019|OG001|Outcome|Depo Provera|Participants self-selected to receive Depo Provera
10843279|NCT00253019|OG002|Outcome|Ortho Evra|Participants self-selected to receive Ortho Evra.
10843280|NCT00253019|EG000|Reported Event|Oral Contraceptives|participants self-selected to take oral contraceptives
10843281|NCT00253019|EG001|Reported Event|Depo Provera|Participants self-selected to use depo provera
10843282|NCT00253019|EG002|Reported Event|Ortho Evra|participants self-selected to receive ortho evra
11219016|NCT02324543|OG000|Outcome|Phase 1|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219017|NCT02324543|OG000|Outcome|Phase 2|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219018|NCT02324543|EG000|Reported Event|Dose Level 1 - Phase 1|"Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219019|NCT02324543|EG001|Reported Event|Dose Level 1a - Phase 1|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219020|NCT02324543|EG002|Reported Event|Dose Level 1b - Phase 1|"Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219021|NCT02324543|EG003|Reported Event|Dose Level 2 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219022|NCT02324543|EG004|Reported Event|Dose Level 3 - Phase 1|"Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219023|NCT02324543|EG005|Reported Event|Phase 2|"Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle~Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle~Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle~Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle"
11219024|NCT02324569|BG000|Baseline|Treatment Group I|SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219025|NCT02324569|BG001|Baseline|Treatment Group II|SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219026|NCT02324569|BG002|Baseline|Total|Total of all reporting groups
11219027|NCT02324569|FG000|Participant Flow|Treatment Group I|SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219028|NCT02324569|FG001|Participant Flow|Treatment Group II|SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219029|NCT02324569|OG000|Outcome|Treatment Group I|SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219030|NCT02324569|OG001|Outcome|Treatment Group II|SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219031|NCT02324569|EG000|Reported Event|Treatment Group I|SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219032|NCT02324569|EG001|Reported Event|Treatment Group II|SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
11219033|NCT02324660|BG000|Baseline|Patients Undergoing Screening and Spirometry|
11219034|NCT02324660|FG000|Participant Flow|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
11219035|NCT02324660|OG000|Outcome|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
11219036|NCT02324660|OG000|Outcome|Screening Test|"all consecutive patients admitted to our hospital for ACS and current/former smokers will be screened according our protocol with PEF and RHSQ. Patients will be blinded to result of both tests. Indipendently to results, all included patients will receive spirometry (50-70 days after inclusion) to assess the presence or not of COPD (primary outcome).~screening test: screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD"
11219037|NCT02324660|EG000|Reported Event|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
11219038|NCT02324673|BG000|Baseline|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
11219039|NCT02324673|BG001|Baseline|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
11219040|NCT02324673|BG002|Baseline|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
11219041|NCT02324673|BG003|Baseline|Total|Total of all reporting groups
11219042|NCT02324673|FG000|Participant Flow|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
11219043|NCT02324673|FG001|Participant Flow|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
11219044|NCT02324673|FG002|Participant Flow|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
11219045|NCT02324673|OG000|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
11219046|NCT02324673|OG001|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
11219047|NCT02324673|OG002|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
11219048|NCT02324673|EG000|Reported Event|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
11219049|NCT02324673|EG001|Reported Event|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
11219050|NCT02324673|EG002|Reported Event|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
11219051|NCT02324699|BG000|Baseline|Prednisone Co-inductive Therapy|"Prednisone vs Identical placebo taper~Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5~Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6."
11219052|NCT02324699|FG000|Participant Flow|Prednisone Co-inductive Therapy|"Prednisone vs Identical placebo taper~Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5~Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6."
11219053|NCT02324699|OG000|Outcome|Prednisone Co-inductive Therapy|"Prednisone vs Identical placebo taper~Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5~Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6."
11219054|NCT02324699|EG000|Reported Event|Prednisone Co-inductive Therapy|"Prednisone vs Identical placebo taper~Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5~Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6."
11219055|NCT02324842|BG000|Baseline|Canagliflozin|"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"
11219056|NCT02324842|BG001|Baseline|Liraglutide|"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219057|NCT02324842|BG002|Baseline|Canagliflozin Plus Liraglutide|"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219058|NCT02324842|BG003|Baseline|Total|Total of all reporting groups
11219059|NCT02324842|FG000|Participant Flow|Canagliflozin|"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"
11219060|NCT02324842|FG001|Participant Flow|Liraglutide|"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219061|NCT02324842|FG002|Participant Flow|Canagliflozin Plus Liraglutide|"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219062|NCT02324842|OG000|Outcome|Canagliflozin|"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"
11219063|NCT02324842|OG001|Outcome|Liraglutide|"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219064|NCT02324842|OG002|Outcome|Canagliflozin Plus Liraglutide|"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219065|NCT02324842|EG000|Reported Event|Canagliflozin|"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"
11219066|NCT02324842|EG001|Reported Event|Liraglutide|"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219067|NCT02324842|EG002|Reported Event|Canagliflozin Plus Liraglutide|"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects~Canagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)~Liraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."
11219068|NCT02324920|BG000|Baseline|Active Pacing (DDD+CLS)|"The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.~DDD-CLS"
11219069|NCT02324920|BG001|Baseline|Inactive Pacing (ODO)|"The pacemaker will be programmed in ODO mode.~ODO"
11219070|NCT02324920|BG002|Baseline|Total|Total of all reporting groups
11219071|NCT02324920|FG000|Participant Flow|Active Pacing (DDD+CLS)|"The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.~DDD-CLS"
11219072|NCT02324920|FG001|Participant Flow|Inactive Pacing (ODO)|"The pacemaker will be programmed in ODO mode.~ODO"
11219073|NCT02324920|OG000|Outcome|Active Pacing (DDD+CLS)|"The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.~DDD-CLS"
11219074|NCT02324920|OG001|Outcome|Inactive Pacing (ODO)|"The pacemaker will be programmed in ODO mode.~ODO"
11219075|NCT02324920|EG000|Reported Event|Active Pacing (DDD+CLS)|"The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.~DDD-CLS"
11219076|NCT02324920|EG001|Reported Event|Inactive Pacing (ODO)|"The pacemaker will be programmed in ODO mode.~ODO"
11219077|NCT02324972|BG000|Baseline|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11219078|NCT02324972|BG001|Baseline|Placebo|"1 x placebo capsule daily~Placebo"
11219079|NCT02324972|BG002|Baseline|Total|Total of all reporting groups
11219080|NCT02324972|FG000|Participant Flow|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11219081|NCT02324972|FG001|Participant Flow|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11219082|NCT02324972|OG000|Outcome|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11219083|NCT02324972|OG001|Outcome|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11219084|NCT02324972|EG000|Reported Event|AQX-1125|"1 x AQX-1125 Capsule daily~AQX-1125: Synthetic SHIP1 activator"
11219085|NCT02324972|EG001|Reported Event|Placebo|"1 x placebo capsule daily~Placebo: Double blind placebo capsule"
11219086|NCT02325219|BG000|Baseline|Placebo (CP)|Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
11219087|NCT02325219|BG001|Baseline|Guselkumab 50 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
11219088|NCT02325219|BG002|Baseline|Guselkumab 100 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
11219089|NCT02325219|BG003|Baseline|Total|Total of all reporting groups
11219090|NCT02325219|FG000|Participant Flow|Placebo (Controlled Period [CP])|Participants stratified by the type of psoriasis (with or without PsA) received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
11219091|NCT02325219|FG001|Participant Flow|Guselkumab 50 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
11219092|NCT02325219|FG002|Participant Flow|Guselkumab 100 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
11219093|NCT02325219|FG003|Participant Flow|Placebo to Guselkumab 50 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
11219094|NCT02325219|FG004|Participant Flow|Placebo to Guselkumab 100 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
11219095|NCT02325219|OG000|Outcome|Placebo (CP)|Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
11219096|NCT02325219|OG001|Outcome|Guselkumab 50 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
11219097|NCT02325219|OG002|Outcome|Guselkumab 100 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
11219098|NCT02325219|OG000|Outcome|Guselkumab 50 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
11219099|NCT02325219|OG001|Outcome|Guselkumab 100 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
11219100|NCT02325219|OG002|Outcome|Placebo to Guselkumab 50 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
11219101|NCT02325219|OG003|Outcome|Placebo to Guselkumab 100 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
11219102|NCT02325219|EG000|Reported Event|Placebo (CP)|Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
11219103|NCT02325219|EG001|Reported Event|Guselkumab 50 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12.
11219104|NCT02325219|EG002|Reported Event|Guselkumab 100 mg (CP)|Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12.
11219105|NCT02325219|EG003|Reported Event|Guselkumab 50 mg (After CP)|Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44.
11219106|NCT02325219|EG004|Reported Event|Guselkumab 100 mg (After CP)|Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44.
11219107|NCT02325219|EG005|Reported Event|Placebo to Guselkumab 50 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
11219108|NCT02325219|EG006|Reported Event|Placebo to Guselkumab 100 mg (After CP)|Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
11219109|NCT02325401|BG000|Baseline|Metformin With Chemoradiation|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219110|NCT02325401|FG000|Participant Flow|Metformin (2000mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2000mg cohort.
11219111|NCT02325401|FG001|Participant Flow|Metformin (2550mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2550mg cohort.
11219112|NCT02325401|FG002|Participant Flow|Metformin (3000mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 3000mg cohort.
11219113|NCT02325401|OG000|Outcome|Metformin (2000mg) With Chemoradiation|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219114|NCT02325401|OG001|Outcome|Metformin (2550mg) With Chemoradiation|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219115|NCT02325401|OG002|Outcome|Metformin (3000mg) With Chemoradiation|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219116|NCT02325401|OG000|Outcome|Metformin (2000mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. Metformin cohort: 2000mg.
11219117|NCT02325401|OG001|Outcome|Metformin (2550mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. Metformin cohort: 2550mg.
11219118|NCT02325401|OG002|Outcome|Metformin (3000mg) With Chemoradiation|Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. Metformin cohort: 3000mg.
11219119|NCT02325401|OG000|Outcome|Metformin (2000mg) With Chemoradiation|Subjects receiving Metformin (2000mg) along with chemoradiation.
11219120|NCT02325401|OG001|Outcome|Metformin (2550mg) With Chemoradiation|Subjects receiving Metformin (2500mg) along with chemoradiation.
11219121|NCT02325401|OG002|Outcome|Metformin (3000mg) With Chemoradiation|Subjects receiving Metformin (2500mg) along with chemoradiation.
11219122|NCT02325401|EG000|Reported Event|Metformin With Chemoradiation- 2000mg Cohort|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219123|NCT02325401|EG001|Reported Event|Metformin With Chemoradiation- 2550mg Cohort|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 2550 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219124|NCT02325401|EG002|Reported Event|Metformin With Chemoradiation- 3000mg Cohort|"Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.~Metformin: Escalating doses of 3000 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.~Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43~Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions"
11219125|NCT02325414|BG000|Baseline|Zoledronic Acid|Intravenous infusion of zoledronic acid (Zol) 5 mg at baseline
11219126|NCT02325414|BG001|Baseline|Placebo|Intravenous infusion of placebo (saline) at baseline.
11219127|NCT02325414|BG002|Baseline|Total|Total of all reporting groups
11219128|NCT02325414|FG000|Participant Flow|Zoledronic Acid|Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.
11219129|NCT02325414|FG001|Participant Flow|Placebo|Intravenous infusion of placebo (saline) at baseline.
11219130|NCT02325414|OG000|Outcome|Zoledronic Acid|"Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.~Zoledronic acid: Intravenous infusion of zoledronic acid 5 mg."
11219131|NCT02325414|OG001|Outcome|Placebo|"Intravenous infusion of placebo at baseline.~Placebo: Placebo (saline) infusion to match zoledronic acid"
11219132|NCT02325414|OG000|Outcome|Zoledronic Acid (Zol)|Intravenous infusion of the study drug zoledronic acid (Zol) 5 mg at baseline.
11219133|NCT02325414|OG001|Outcome|Placebo (Pla)|"Intravenous infusion of placebo at baseline.~Placebo (Pla): saline"
11219134|NCT02325414|EG000|Reported Event|Zoledronic Acid|Intravenous infusion of the study drug zoledronic acid (Zol) 5 mg at baseline.
11219135|NCT02325414|EG001|Reported Event|Placebo|"Intravenous infusion of placebo at baseline.~Placebo (Pla): saline"
11219136|NCT02325518|BG000|Baseline|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219137|NCT02325518|BG001|Baseline|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219138|NCT02325518|BG002|Baseline|Total|Total of all reporting groups
11219139|NCT02325518|FG000|Participant Flow|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual prostaglandin-analog (PGA) monotherapy, 1 drop in each eye once daily for 8 weeks.
11219140|NCT02325518|FG001|Participant Flow|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219141|NCT02325518|OG000|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219142|NCT02325518|OG001|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219143|NCT02325518|EG000|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
11219144|NCT02325518|EG001|Reported Event|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219145|NCT02325518|EG002|Reported Event|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
11219146|NCT02325687|BG000|Baseline|Treated OSA (CPAP-compliant)|"Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219147|NCT02325687|BG001|Baseline|Untreated OSA (Non-CPAP-compliant)|"Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219148|NCT02325687|BG002|Baseline|Control (No Suspicion of OSA)|"Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score <3 are considered to have minimal risk for OSA and will be included in the control group.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219149|NCT02325687|BG003|Baseline|Total|Total of all reporting groups
11219150|NCT02325687|FG000|Participant Flow|Treated OSA (CPAP-compliant)|"Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219151|NCT02325687|FG001|Participant Flow|Untreated OSA (Non-CPAP-compliant)|"Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11335721|NCT03555266|OG001|Outcome|Sham NSS-2 BRIDGE and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol~Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol."
11219152|NCT02325687|FG002|Participant Flow|Control (No Suspicion of OSA)|"Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score <3 are considered to have minimal risk for OSA and will be included in the control group.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219153|NCT02325687|OG000|Outcome|Treated OSA (CPAP-compliant)|"Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219154|NCT02325687|OG001|Outcome|Untreated OSA (Non-CPAP-compliant)|"Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219155|NCT02325687|OG002|Outcome|Control (No Suspicion of OSA)|"Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score <3 are considered to have minimal risk for OSA and will be included in the control group.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219156|NCT02325687|EG000|Reported Event|Treated OSA (CPAP-compliant)|"Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219157|NCT02325687|EG001|Reported Event|Untreated OSA (Non-CPAP-compliant)|"Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11219158|NCT02325687|EG002|Reported Event|Control (No Suspicion of OSA)|"Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score <3 are considered to have minimal risk for OSA and will be included in the control group.~Intervention: Lumbar Puncture (Standard-of-Care)~Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia)."
11335722|NCT03555266|EG000|Reported Event|NSS-2 Bridge and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.~NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol."
11219159|NCT02325713|BG000|Baseline|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219160|NCT02325713|BG001|Baseline|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219161|NCT02325713|BG002|Baseline|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219162|NCT02325713|BG003|Baseline|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219163|NCT02325713|BG004|Baseline|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219164|NCT02325713|BG005|Baseline|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219165|NCT02325713|BG006|Baseline|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219166|NCT02325713|BG007|Baseline|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219167|NCT02325713|BG008|Baseline|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219168|NCT02325713|BG009|Baseline|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219169|NCT02325713|BG010|Baseline|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219170|NCT02325713|BG011|Baseline|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219171|NCT02325713|BG012|Baseline|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219172|NCT02325713|BG013|Baseline|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219173|NCT02325713|BG014|Baseline|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219174|NCT02325713|BG015|Baseline|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219175|NCT02325713|BG016|Baseline|Total|Total of all reporting groups
11219176|NCT02325713|FG000|Participant Flow|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219177|NCT02325713|FG001|Participant Flow|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219178|NCT02325713|FG002|Participant Flow|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
10843283|NCT00253370|BG000|Baseline|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
10843284|NCT00253370|FG000|Participant Flow|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
10843285|NCT00253370|OG000|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
10843286|NCT00253370|OG000|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
10843287|NCT00253370|EG000|Reported Event|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
10843288|NCT00253435|BG000|Baseline|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
10843289|NCT00253435|BG001|Baseline|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
10843290|NCT00253435|BG002|Baseline|Total|Total of all reporting groups
10843291|NCT00253435|FG000|Participant Flow|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
10843292|NCT00253435|FG001|Participant Flow|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
10843293|NCT00253435|OG000|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
10843294|NCT00253435|OG001|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
10843295|NCT00253435|EG000|Reported Event|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
10843296|NCT00253435|EG001|Reported Event|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
10843297|NCT00253448|BG000|Baseline|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
10843298|NCT00253448|FG000|Participant Flow|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
10843299|NCT00253448|OG000|Outcome|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
10843300|NCT00253448|EG000|Reported Event|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
10843301|NCT00253513|BG000|Baseline|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
10843302|NCT00253513|FG000|Participant Flow|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
10843303|NCT00253513|OG000|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
10843304|NCT00253513|EG000|Reported Event|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
10843305|NCT00253630|BG000|Baseline|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
10843306|NCT00253630|FG000|Participant Flow|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
10843307|NCT00253630|OG000|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
10843308|NCT00253630|EG000|Reported Event|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
11219179|NCT02325713|FG003|Participant Flow|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219180|NCT02325713|FG004|Participant Flow|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219181|NCT02325713|FG005|Participant Flow|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219182|NCT02325713|FG006|Participant Flow|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219183|NCT02325713|FG007|Participant Flow|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219184|NCT02325713|FG008|Participant Flow|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219185|NCT02325713|FG009|Participant Flow|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219186|NCT02325713|FG010|Participant Flow|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219187|NCT02325713|FG011|Participant Flow|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219188|NCT02325713|FG012|Participant Flow|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219189|NCT02325713|FG013|Participant Flow|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219190|NCT02325713|FG014|Participant Flow|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219191|NCT02325713|FG015|Participant Flow|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
11219192|NCT02325713|OG000|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219193|NCT02325713|OG001|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
11219194|NCT02325713|OG002|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219195|NCT02325713|OG003|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219196|NCT02325713|OG004|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
11219197|NCT02325713|OG005|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
11219198|NCT02325713|OG000|Outcome|PZQ 40 mg/kg (Treatment A and Treatment B)|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal and reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
11219199|NCT02325713|EG000|Reported Event|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219200|NCT02325713|EG001|Reported Event|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
11219201|NCT02325713|EG002|Reported Event|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219202|NCT02325713|EG003|Reported Event|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
11219203|NCT02325713|EG004|Reported Event|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
11219204|NCT02325713|EG005|Reported Event|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
11219205|NCT02325739|BG000|Baseline|Phase I: 50 mg Fasted|Participants received single agent FGF401 50 mg while fasted
11219206|NCT02325739|BG001|Baseline|Phase I: 80 mg Fasted|Participants received single agent FGF401 80 mg while fasted
11219207|NCT02325739|BG002|Baseline|Phase I: 80 mg Fed|Participants received single agent FGF401 80 mg while fed
11219208|NCT02325739|BG003|Baseline|Phase I: 120 mg Fasted|Participants received single agent FGF401 120 mg while fasted
11219209|NCT02325739|BG004|Baseline|Phase I: 120 mg Fed|Participants received single agent FGF401 120 mg while fed
11219210|NCT02325739|BG005|Baseline|Phase I: 150 mg Fasted|Participants received single agent FGF401 150 mg while fasted
11219211|NCT02325739|BG006|Baseline|Phase I: FGF401 80 mg + PDR001 300 mg|Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
11219212|NCT02325739|BG007|Baseline|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219213|NCT02325739|BG008|Baseline|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219214|NCT02325739|BG009|Baseline|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219215|NCT02325739|BG010|Baseline|PhaseII: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219216|NCT02325739|BG011|Baseline|Total|Total of all reporting groups
11219217|NCT02325739|FG000|Participant Flow|Phase I: 50 mg Fasted|Participants received single agent FGF401 50 mg while fasted
11219218|NCT02325739|FG001|Participant Flow|Phase I: 80 mg Fasted|Participants received single agent FGF401 80 mg while fasted
11219219|NCT02325739|FG002|Participant Flow|Phase I: 80 mg Fed|Participants received single agent FGF401 80 mg while fed
11219220|NCT02325739|FG003|Participant Flow|Phase I: 120 mg Fasted|Participants received single agent FGF401 120 mg while fasted
11219221|NCT02325739|FG004|Participant Flow|Phase I: 120 mg Fed|Participants received single agent FGF401 120 mg while fed
11219222|NCT02325739|FG005|Participant Flow|Phase I: 150 mg Fasted|Participants received single agent FGF401 150 mg while fasted
11219223|NCT02325739|FG006|Participant Flow|Phase I: FGF401 80 mg + PDR001 300 mg|Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
11219224|NCT02325739|FG007|Participant Flow|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219225|NCT02325739|FG008|Participant Flow|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219226|NCT02325739|FG009|Participant Flow|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219227|NCT02325739|FG010|Participant Flow|PhaseII: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219228|NCT02325739|OG000|Outcome|Phase I: 50 mg Fasted|Participants received single agent FGF401 50 mg while fasted
11219229|NCT02325739|OG001|Outcome|Phase I: 80 mg Fasted|Participants received single agent FGF401 80 mg while fasted
11219230|NCT02325739|OG002|Outcome|Phase I: 80 mg Fed|Participants received single agent FGF401 80 mg while fed
11219231|NCT02325739|OG003|Outcome|Phase I: 120 mg Fasted|Participants received single agent FGF401 120 mg while fasted
11219232|NCT02325739|OG004|Outcome|Phase I: 120 mg Fed|Participants received single agent FGF401 120 mg while fed
11219233|NCT02325739|OG005|Outcome|Phase I: 150 mg Fasted|Participants received single agent FGF401 150 mg while fasted
11219234|NCT02325739|OG006|Outcome|Phase I: FGF401 80 mg + PDR001 300 mg|Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
11219235|NCT02325739|OG007|Outcome|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219236|NCT02325739|OG000|Outcome|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219237|NCT02325739|OG001|Outcome|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219238|NCT02325739|OG000|Outcome|PhaseII: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219239|NCT02325739|OG008|Outcome|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219240|NCT02325739|OG009|Outcome|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219241|NCT02325739|OG010|Outcome|PhaseII: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219242|NCT02325739|OG000|Outcome|Phase I: 120 mg Fasted|Participants received single agent FGF401 120 mg while fasted
11219243|NCT02325739|OG001|Outcome|Phase I: 120 mg Fed|Participants received single agent FGF401 120 mg while fed
11219244|NCT02325739|OG002|Outcome|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219245|NCT02325739|OG003|Outcome|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219246|NCT02325739|OG004|Outcome|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219247|NCT02325739|OG005|Outcome|PhaseII: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219248|NCT02325739|OG001|Outcome|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219249|NCT02325739|OG006|Outcome|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219250|NCT02325739|OG007|Outcome|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219251|NCT02325739|OG008|Outcome|Phase II: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219252|NCT02325739|OG009|Outcome|All Patients of Single Agent FGF401|These were all the participants who received single dose of FGF401
11219253|NCT02325739|OG010|Outcome|Phase I: FGF401 80 mg + PDR001 300 mg|Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
11219254|NCT02325739|OG011|Outcome|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219255|NCT02325739|OG012|Outcome|All Patients of Combination Dose|These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
11219256|NCT02325739|OG013|Outcome|All Patients|Overall participants in the in Phase I & Phase II of study
11219257|NCT02325739|EG000|Reported Event|Phase I: 50 mg Fasted|Participants received single agent FGF401 50 mg while fasted
11219258|NCT02325739|EG001|Reported Event|Phase I: 80 mg Fasted|Participants received single agent FGF401 80 mg while fasted
11219259|NCT02325739|EG002|Reported Event|Phase I: 80 mg Fed|Participants received single agent FGF401 80 mg while fed
11219260|NCT02325739|EG003|Reported Event|Phase I: 120 mg Fasted|Participants received single agent FGF401 120 mg while fasted
10834374|NCT00162097|FG001|Participant Flow|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
10834375|NCT00162097|FG002|Participant Flow|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
10834376|NCT00162097|FG003|Participant Flow|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
10834377|NCT00162097|OG000|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
10834378|NCT00162097|OG001|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
10843309|NCT00253643|BG000|Baseline|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
11219261|NCT02325739|EG004|Reported Event|Phase I: 120 mg Fed|Participants received single agent FGF401 120 mg while fed
11219262|NCT02325739|EG005|Reported Event|Phase I: 150 mg Fasted|Participants received single agent FGF401 150 mg while fasted
11219263|NCT02325739|EG006|Reported Event|Phase II: Group 1 - FGF401 120 mg QD|Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
11219264|NCT02325739|EG007|Reported Event|Phase II: Group 2 - FGF401 120 mg QD|Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
11219265|NCT02325739|EG008|Reported Event|Phase II: Group 3 - FGF401 120 mg QD|Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
11219266|NCT02325739|EG009|Reported Event|All Patients of Single Agent FGF401|These were all the participants who received single dose of FGF401
11219267|NCT02325739|EG010|Reported Event|Phase I: FGF401 80 mg + PDR001 300 mg|Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
11219268|NCT02325739|EG011|Reported Event|Phase I: FGF401 120 mg + PDR001 300 mg|Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
11219269|NCT02325739|EG012|Reported Event|All Patients of Combination Dose|These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
11219270|NCT02325739|EG013|Reported Event|All Patients|Overall participants in the in Phase I & Phase II of study
11219271|NCT02325791|BG000|Baseline|Part A: Suptavumab 30 mg/kg|Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
11219272|NCT02325791|BG001|Baseline|Part B: Placebo Matched to Suptavumab|Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
11219273|NCT02325791|BG002|Baseline|Part B: Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
11219274|NCT02325791|BG003|Baseline|Part B: Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM:the first dose on Day 1 and the second dose on Day 57.
11219275|NCT02325791|BG004|Baseline|Total|Total of all reporting groups
11219276|NCT02325791|FG000|Participant Flow|Part A: Suptavumab 30 mg/kg|Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
11219277|NCT02325791|FG001|Participant Flow|Part B: Placebo Matched to Suptavumab|Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
11219278|NCT02325791|FG002|Participant Flow|Part B: Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
11219279|NCT02325791|FG003|Participant Flow|Part B: Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
11219280|NCT02325791|OG000|Outcome|Part A: Suptavumab 30 mg/kg - 1 Dose|Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
11219281|NCT02325791|OG000|Outcome|Part B: Placebo Matched to Suptavumab|Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
11219282|NCT02325791|OG001|Outcome|Part B: Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
11219283|NCT02325791|OG002|Outcome|Part B: Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
10834379|NCT00162097|OG002|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
10834380|NCT00162097|OG003|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
10834381|NCT00162097|OG000|Outcome|Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
10834382|NCT00162097|OG001|Outcome|Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
10834383|NCT00162097|OG002|Outcome|Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
10834384|NCT00162097|OG003|Outcome|Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
10834385|NCT00162097|OG004|Outcome|Participants Not Dosed|Participants were enrolled in the study and discontinued prior to study drug administration
10834386|NCT00162097|EG000|Reported Event|EFV600mg Participants With Mild Hepatic Impairment|
10834387|NCT00162097|EG001|Reported Event|EFV600mg Participants With Moderate Hepatic Impairment|
10834388|NCT00162097|EG002|Reported Event|EFV600mg Participants With Severe Hepatic Impairment|
10834389|NCT00162097|EG003|Reported Event|EFV600mg Participants With Normal Hepatic Function|
10834390|NCT00162097|EG004|Reported Event|Not Dosed|
10834391|NCT00162123|BG000|Baseline|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834392|NCT00162123|BG001|Baseline|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834393|NCT00162123|BG002|Baseline|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834394|NCT00162123|BG003|Baseline|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
10834395|NCT00162123|BG004|Baseline|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834396|NCT00162123|BG005|Baseline|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834397|NCT00162123|BG006|Baseline|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834398|NCT00162123|BG007|Baseline|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
10834399|NCT00162123|BG008|Baseline|Total|Total of all reporting groups
10834400|NCT00162123|FG000|Participant Flow|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834401|NCT00162123|FG001|Participant Flow|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834402|NCT00162123|FG002|Participant Flow|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834403|NCT00162123|FG003|Participant Flow|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
10834404|NCT00162123|FG004|Participant Flow|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834405|NCT00162123|FG005|Participant Flow|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834406|NCT00162123|FG006|Participant Flow|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834407|NCT00162123|FG007|Participant Flow|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
10834408|NCT00162123|OG000|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834409|NCT00162123|OG001|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834410|NCT00162123|OG002|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834411|NCT00162123|OG002|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834412|NCT00162123|OG003|Outcome|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834413|NCT00162123|OG004|Outcome|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834414|NCT00162123|OG005|Outcome|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834415|NCT00162123|OG006|Outcome|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
11219284|NCT02325791|OG000|Outcome|Part A: Suptavumab 30 mg/kg|Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
11219285|NCT02325791|OG000|Outcome|Part B: Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
11219286|NCT02325791|OG001|Outcome|Part B: Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
11219287|NCT02325791|EG000|Reported Event|Part A: Suptavumab 30 mg/kg|Participants received single dose of suptavumab 30 mg/kg IM on Day 1.
11219288|NCT02325791|EG001|Reported Event|Part B: Placebo Matched to Suptavumab|Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
11219289|NCT02325791|EG002|Reported Event|Part B: Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
11219290|NCT02325791|EG003|Reported Event|Part B: Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
11219291|NCT02325856|BG000|Baseline|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
11219292|NCT02325856|BG001|Baseline|Control Group|Dry weight determined by clinical symptoms
11219293|NCT02325856|BG002|Baseline|Total|Total of all reporting groups
11219294|NCT02325856|FG000|Participant Flow|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
11219295|NCT02325856|FG001|Participant Flow|Control Group|Dry weight determined by clinical symptoms
11219296|NCT02325856|OG000|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
11219297|NCT02325856|OG001|Outcome|Control Group|Dry weight determined by clinical symptoms
11219298|NCT02325856|EG000|Reported Event|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
11219299|NCT02325856|EG001|Reported Event|Control Group|Dry weight determined by clinical symptoms
11219300|NCT02326025|BG000|Baseline|Part A|"Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).~Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.~Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met."
11219301|NCT02326025|BG001|Baseline|Part B|"Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV~Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.~Olaratumab + Doxorubicin:~For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met."
11219302|NCT02326025|BG002|Baseline|Total|Total of all reporting groups
11219303|NCT02326025|FG000|Participant Flow|Part A|"Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).~Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.~Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met."
11219304|NCT02326025|FG001|Participant Flow|Part B|"Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV~Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.~Olaratumab + Doxorubicin:~For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met."
11219305|NCT02326025|OG000|Outcome|Part A Doxorubicin Alone|On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
11219306|NCT02326025|OG001|Outcome|Part A Doxorubicin + 15 mg/kg Olaratumab|On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
11219307|NCT02326025|OG002|Outcome|Part B Doxorubicin Alone|On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
11219308|NCT02326025|OG003|Outcome|Part B Doxorubicin + 20 mg/kg Olaratumab|On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
11219309|NCT02326025|OG000|Outcome|Part A Doxorubicin Alone|On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin, IV.
11219310|NCT02326025|OG000|Outcome|Olaratumab Alone Part A|On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
11219311|NCT02326025|OG001|Outcome|Part A 15 mg/kg Olaratumab + Doxorubicin|On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
11219312|NCT02326025|OG002|Outcome|Part B Olaratumab Alone|On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV
11219313|NCT02326025|OG003|Outcome|Part B 20 mg/kg Olaratumab + Doxorubicin|On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
11219314|NCT02326025|OG000|Outcome|Part A Olaratumab Alone|On Cycle 1, Day 10, participants received 15 mg/kg of olaratumab, IV.
11219315|NCT02326025|OG002|Outcome|Part B Olaratumab Alone|On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV.
11219316|NCT02326025|OG000|Outcome|Part A 15 mg/kg Olaratumab|"Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met."
11219317|NCT02326025|OG001|Outcome|Part B 20 mg/kg Olaratumab|"Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met."
11219318|NCT02326025|OG000|Outcome|Part A Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab|"Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).~Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.~Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met."
11219319|NCT02326025|OG001|Outcome|Part B Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab|"Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV~Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.~Olaratumab + Doxorubicin:~For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met."
11219320|NCT02326025|EG000|Reported Event|Part A|"Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).~Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.~Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met."
11219321|NCT02326025|EG001|Reported Event|Part B|"Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV~Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.~Olaratumab + Doxorubicin:~For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.~Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met."
11219322|NCT02326220|BG000|Baseline|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
11219323|NCT02326220|BG001|Baseline|Alirocumab 150 mg Q2W (Double Blind Period)|Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
11219324|NCT02326220|BG002|Baseline|Total|Total of all reporting groups
11219325|NCT02326220|FG000|Participant Flow|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
11219326|NCT02326220|FG001|Participant Flow|Alirocumab 150 mg Q2W (Double Blind Period)|Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. (Participants undergoing LDL apheresis therapy every 1 or 2 weeks were enrolled in this study while maintaining background lipid modifying therapy (LMT) treatment throughout the study. All participants were being treated with the maximally tolerated clinically-relevant LMT).
11219327|NCT02326220|FG002|Participant Flow|Alirocumab 150 Q2W (Open Label Treatment Period)|Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76 or until alirocumab became commercially available in the subject's country, whichever occurred first. Apheresis treatment not required in the open-label treatment period and could be stopped or continued at the investigator's discretion. (All participants were being treated with the maximally tolerated clinically-relevant LMT.)
11219328|NCT02326220|OG000|Outcome|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
10834416|NCT00162123|OG001|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834417|NCT00162123|EG000|Reported Event|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834418|NCT00162123|EG001|Reported Event|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834419|NCT00162123|EG002|Reported Event|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
10834420|NCT00162123|EG003|Reported Event|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
10834421|NCT00162123|EG004|Reported Event|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834422|NCT00162123|EG005|Reported Event|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834423|NCT00162123|EG006|Reported Event|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
10834424|NCT00162123|EG007|Reported Event|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
10834425|NCT00162136|BG000|Baseline|10 mg/m2|Ixabepilone
10834426|NCT00162136|BG001|Baseline|20 mg/m2|Ixabepilone
10834427|NCT00162136|BG002|Baseline|30 mg/m2|Ixabepilone
10834428|NCT00162136|BG003|Baseline|35 mg/m2|Ixabepilone
10834429|NCT00162136|BG004|Baseline|40 mg/m2|Ixabepilone
10834430|NCT00162136|BG005|Baseline|45 mg/m2|Ixabepilone
10834431|NCT00162136|BG006|Baseline|Total|Total of all reporting groups
10834432|NCT00162136|FG000|Participant Flow|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
10834433|NCT00162136|OG000|Outcome|10 mg/m2|Ixabepilone
10834434|NCT00162136|OG001|Outcome|20 mg/m2|Ixabepilone
10834435|NCT00162136|OG002|Outcome|30 mg/m2|Ixabepilone
10834436|NCT00162136|OG003|Outcome|35 mg/m2|Ixabepilone
10834437|NCT00162136|OG004|Outcome|40 mg/m2|Ixabepilone
10834438|NCT00162136|OG005|Outcome|45 mg/m2|Ixabepilone
10834439|NCT00162136|OG000|Outcome|Grade 1/2|Grade 1=Mild, Grade 2=Moderate
10834440|NCT00162136|OG001|Outcome|Grade 3/4|Grade 3=Severe, Grade 4=Life-threatening or disabling
10834441|NCT00162136|OG002|Outcome|All Grades|Grades 1-4
10834442|NCT00162136|OG000|Outcome|Grade 0|Absent
10834443|NCT00162136|OG001|Outcome|Grade 1|Mild
10834444|NCT00162136|OG002|Outcome|Grade 2|Moderate
10834445|NCT00162136|OG003|Outcome|Grade 3|Severe
10834446|NCT00162136|OG004|Outcome|Grade 4|Life-threatening or disabling
10834447|NCT00162136|OG000|Outcome|Treated Subjects|All treated subjects with measurement at timepoint
10834448|NCT00162136|OG000|Outcome|All Treated Participants|
10834449|NCT00162136|EG000|Reported Event|Ixa 10 mg/m2|
10834450|NCT00162136|EG001|Reported Event|Ixa 20 mg/m2|
10834451|NCT00162136|EG002|Reported Event|Ixa 30 mg/m2|
10834452|NCT00162136|EG003|Reported Event|Ixa 35 mg/m2|
10834453|NCT00162136|EG004|Reported Event|Ixa 40 mg/m2|
10834454|NCT00162136|EG005|Reported Event|Ixa 45 mg/m2|
10834455|NCT00162266|BG000|Baseline|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10842854|NCT00249834|FG006|Participant Flow|Gonal-f 262.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10834456|NCT00162266|BG001|Baseline|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834457|NCT00162266|BG002|Baseline|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834458|NCT00162266|BG003|Baseline|Total|Total of all reporting groups
10834459|NCT00162266|FG000|Participant Flow|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834460|NCT00162266|FG001|Participant Flow|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834461|NCT00162266|FG002|Participant Flow|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834462|NCT00162266|FG003|Participant Flow|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
10834463|NCT00162266|OG000|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834464|NCT00162266|OG001|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
10834465|NCT00162266|OG002|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
10834466|NCT00162266|OG000|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834467|NCT00162266|OG001|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834468|NCT00162266|OG002|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834469|NCT00162266|OG000|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10843310|NCT00253643|BG001|Baseline|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
11219329|NCT02326220|OG001|Outcome|Alirocumab 150 mg Q2W (Double Blind Period)|Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
11219330|NCT02326220|OG000|Outcome|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment.
11219331|NCT02326220|OG000|Outcome|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment.
11219332|NCT02326220|OG001|Outcome|Alirocumab 150 mg Q2W (Double Blind Period)|Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment
11219333|NCT02326220|EG000|Reported Event|Placebo Q2W (Double Blind Period)|Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16 (mean exposure of 17 weeks).
11219334|NCT02326220|EG001|Reported Event|Alirocumab 150 Q2W (Double Blind Period)|Alirocumab 150 mg SC injection Q2W up to Week 16 (mean exposure of 17 weeks).
11219335|NCT02326220|EG002|Reported Event|Alirocumab 150 Q2W (Open Label Treatment Period)|Alirocumab 150 mg SC injection Q2W from Week 18 (mean exposure of 17 weeks).
11219336|NCT02326233|BG000|Baseline|Pen of SB5|"Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)~Pen of SB5"
11219337|NCT02326233|BG001|Baseline|PFS of SB5|"PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)~PFS of SB5"
11219338|NCT02326233|BG002|Baseline|Total|Total of all reporting groups
11219339|NCT02326233|FG000|Participant Flow|Pen of SB5|"Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)~Pen of SB5"
11219340|NCT02326233|FG001|Participant Flow|PFS of SB5|"PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)~PFS of SB5"
11219341|NCT02326233|OG000|Outcome|Pen of SB5|"Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)~Pen of SB5"
11219342|NCT02326233|OG001|Outcome|PFS of SB5|"PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)~PFS of SB5"
11219343|NCT02326233|EG000|Reported Event|Pen of SB5|"Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)~Pen of SB5"
11219344|NCT02326233|EG001|Reported Event|PFS of SB5|"PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)~PFS of SB5"
11219345|NCT02326272|BG000|Baseline|Placebo Q2W|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W."
11219346|NCT02326272|BG001|Baseline|CZP 200 mg Q2W|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study."
11219347|NCT02326272|BG002|Baseline|CZP 400 mg Q2W|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W."
11219348|NCT02326272|BG003|Baseline|Total Title|
11219349|NCT02326272|FG000|Participant Flow|Placebo Q2W|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W."
11336205|NCT03563027|EG001|Reported Event|Social Incentive Gamification|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game"
11219350|NCT02326272|FG001|Participant Flow|CZP 200 mg Q2W|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study."
11219351|NCT02326272|FG002|Participant Flow|CZP 400 mg Q2W|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W."
11219352|NCT02326272|FG003|Participant Flow|Placebo/Placebo Q2W|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).
11219353|NCT02326272|FG004|Participant Flow|Placebo/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).
11219354|NCT02326272|FG005|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.
11219355|NCT02326272|FG006|Participant Flow|CZP 400 mg Q2W/CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.
11219356|NCT02326272|FG007|Participant Flow|Placebo/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219357|NCT02326272|FG008|Participant Flow|CZP 200 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219358|NCT02326272|FG009|Participant Flow|CZP 400 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219359|NCT02326272|FG010|Participant Flow|Placebo/CZP 200 mg Q2W OLE|This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.
11219360|NCT02326272|FG011|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE.
11219361|NCT02326272|FG012|Participant Flow|CZP 400 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.
11219362|NCT02326272|FG013|Participant Flow|CZP 400 mg Q2W/CZP 400 mg Q2W OLE|This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.
11219363|NCT02326272|FG014|Participant Flow|Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE|This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.
11219364|NCT02326272|OG000|Outcome|Placebo Q2W (RS)|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants formed the Randomized Set (RS)."
11219365|NCT02326272|OG001|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.~Participants formed the RS."
11219366|NCT02326272|OG002|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.~Participants formed the RS."
11219367|NCT02326272|OG000|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.~Participants formed the RS."
11219368|NCT02326272|OG001|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.~Participants formed the RS."
11219369|NCT02326272|EG000|Reported Event|CZP 200 mg Q2W (TCS)|This arm consisted of all participants who received CZP 200 mg at any time during the study.
11219370|NCT02326272|EG001|Reported Event|CZP 400 mg Q2W (TCS)|This arm consisted of all participants who received CZP 400 mg at any time during the study.
11219371|NCT02326298|BG000|Baseline|Placebo Q2W|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W."
11219372|NCT02326298|BG001|Baseline|CZP 200 mg Q2W|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study."
11219373|NCT02326298|BG002|Baseline|CZP 400 mg Q2W|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W."
11219374|NCT02326298|BG003|Baseline|Total Title|
11219375|NCT02326298|FG000|Participant Flow|Placebo Q2W|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W."
11219376|NCT02326298|FG001|Participant Flow|CZP 200 mg Q2W|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study."
11219377|NCT02326298|FG002|Participant Flow|CZP 400 mg Q2W|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W."
11219378|NCT02326298|FG003|Participant Flow|Placebo/Placebo Q2W|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).
11219379|NCT02326298|FG004|Participant Flow|Placebo/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).
11219380|NCT02326298|FG005|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.
11219381|NCT02326298|FG006|Participant Flow|CZP 400 mg Q2W/CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.
11219382|NCT02326298|FG007|Participant Flow|Placebo/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219383|NCT02326298|FG008|Participant Flow|CZP 200 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219384|NCT02326298|FG009|Participant Flow|CZP 400 mg Q2W/Escape CZP 400 mg Q2W|This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
11219385|NCT02326298|FG010|Participant Flow|Placebo/CZP 200 mg Q2W OLE|This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.
11219386|NCT02326298|FG011|Participant Flow|CZP 200 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received blinded CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE on the CZP 200mg Q2W dose.
11219387|NCT02326298|FG012|Participant Flow|CZP 400 mg Q2W/CZP 200 mg Q2W OLE|This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.
11219388|NCT02326298|FG013|Participant Flow|Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE|This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.
11219389|NCT02326298|OG000|Outcome|Placebo Q2W (RS)|"Placebo sc injection Q2W.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.~PASI75 responders at Week 16 continued to receive Placebo.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants formed the Randomized Set (RS)."
11219390|NCT02326298|OG001|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.~Participants formed the RS."
10834470|NCT00162266|OG001|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834471|NCT00162266|OG002|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
10834472|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834473|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834474|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834475|NCT00162266|OG000|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
10834476|NCT00162266|OG003|Outcome|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
10834477|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834478|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834479|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834480|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834481|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834482|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834483|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834484|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834485|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834486|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
11219391|NCT02326298|OG002|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.~Participants formed the RS."
11219392|NCT02326298|OG000|Outcome|CZP 200 mg Q2W (RS)|"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.~Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.~Participants formed the RS."
11219393|NCT02326298|OG001|Outcome|CZP 400 mg Q2W (RS)|"CZP 400 mg Q2W through Week 14.~Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:~PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.~PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.~PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.~Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.~Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.~Participants formed the RS."
11219394|NCT02326298|EG000|Reported Event|CZP 200 mg Q2W (TCS)|This arm consisted of all participants who received CZP 200 mg at any time during the study.
11219395|NCT02326298|EG001|Reported Event|CZP 400 mg Q2W (TCS)|This arm consisted of all participants who received CZP 400 mg at any time during the study.
11219396|NCT02326363|BG000|Baseline|Mindfulness Based Relapse Prevention (MBRP):|Mindfulness Based Relapse Prevention (MBRP): Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan).
11219397|NCT02326363|BG001|Baseline|Twelve-Step Facilitation Intervention (TSF)|The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery (Brown et al., 2002). The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics.
11219398|NCT02326363|BG002|Baseline|Total|Total of all reporting groups
11219399|NCT02326363|FG000|Participant Flow|Mindfulness Based Relapse Prevention (MBRP):|Mindfulness Based Relapse Prevention (MBRP): Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan).
11219400|NCT02326363|FG001|Participant Flow|Twelve-Step Facilitation Intervention (TSF)|The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery (Brown et al., 2002). The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics.
11219401|NCT02326363|OG000|Outcome|Mindfulness Based Relapse Prevention (MBRP):|Mindfulness Based Relapse Prevention (MBRP): Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan).
11333825|NCT03520387|BG004|Baseline|Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11219402|NCT02326363|OG001|Outcome|Twelve-Step Facilitation Intervention (TSF)|The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery (Brown et al., 2002). The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics.
11219403|NCT02326363|OG000|Outcome|Mindfulness Based Relapse Prevention (MBRP):|"The Introductory session provides an orientation to the intervention, basic mindfulness techniques and general description of group sessions. Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of mindfulness meditation (MM) practices such as breath meditation, urge surfing, walking or movement meditation.~Mindfulness Based Relapse Prevention (MBRP): Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of MM practices such as breath meditation, urge surfing, walking or movement meditation."
10834487|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834488|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an on OL weight-tiered dose of abatacept 10 mg/kg.
10834489|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834490|NCT00162266|OG000|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
10834491|NCT00162266|OG000|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
10834492|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834493|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg /kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834494|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834495|NCT00162266|OG000|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
10834496|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834497|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834498|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834499|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834500|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834501|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834502|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834503|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
10834504|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834505|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg /kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834506|NCT00162266|OG002|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
11219404|NCT02326363|OG001|Outcome|Twelve-Step Facilitation Intervention (TSF)|"The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery. The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics. The intervention involves helping participants understand and incorporate core principles of 12-Step approaches while encouraging active participation in 12-Step meetings and related activities. The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a take home summary and homework assignment.~Twelve-Step Facilitation Intervention (TSF): The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a take home summary and homework assignment."
11219405|NCT02326363|EG000|Reported Event|Mindfulness Based Relapse Prevention (MBRP):|Mindfulness Based Relapse Prevention (MBRP): Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan).
11219406|NCT02326363|EG001|Reported Event|Twelve-Step Facilitation Intervention (TSF)|The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery (Brown et al., 2002). The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics.
11219407|NCT02326467|BG000|Baseline|Chlorhexidine Gluconate Bath|"All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were to be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels were to be monitored for associated adverse events and accumulation.~Chlorhexidine gluconate: Bi-weekly chlorhexidine baths"
11219408|NCT02326467|FG000|Participant Flow|Chlorhexidine Gluconate Bath|"All subjects were to receive a bath twice a week with 2% CHG bathing cloths. The baths were to be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels were to be monitored for associated adverse events and accumulation.~Chlorhexidine gluconate: Bi-weekly chlorhexidine baths"
11219409|NCT02326467|OG000|Outcome|Chlorhexidine Gluconate Bath|"All subjects will receive a bath twice a week with 2% CHG bathing cloths. The baths will be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team will monitor the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels will be monitored for associated adverse events and accumulation.~Chlorhexidine gluconate: Bi-weekly chlorhexidine baths"
11219410|NCT02326467|OG000|Outcome|Chlorhexidine Gluconate Bath|"All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels were monitored for associated adverse events and accumulation.~Chlorhexidine gluconate: Bi-weekly chlorhexidine baths"
11219411|NCT02326467|EG000|Reported Event|Chlorhexidine Gluconate Bath|"All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels were monitored for associated adverse events and accumulation.~Chlorhexidine gluconate: Bi-weekly chlorhexidine baths"
11219412|NCT02326597|BG000|Baseline|Standard Practice|Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
11219413|NCT02326597|BG001|Baseline|Standard Practice + Decision Aid|Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219414|NCT02326597|BG002|Baseline|Total|Total of all reporting groups
11219415|NCT02326597|FG000|Participant Flow|Standard Practice|Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
11219416|NCT02326597|FG001|Participant Flow|Standard Practice + Decision Aid|Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219417|NCT02326597|OG000|Outcome|Standard Practice and Standard Practice + Decision Aid Groups|Participants received standard of care teaching and discussion. Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219418|NCT02326597|OG000|Outcome|Standard Practice|Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
11219419|NCT02326597|OG001|Outcome|Standard Practice + Decision Aid|Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219420|NCT02326597|OG000|Outcome|Standard Practice + Decision Aid|Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219421|NCT02326597|EG000|Reported Event|Standard Practice|Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
11219422|NCT02326597|EG001|Reported Event|Standard Practice + Decision Aid|Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
11219423|NCT02326649|BG000|Baseline|Diagnosis, Age, and Body Size of Subjects|Overall
11333826|NCT03520387|BG005|Baseline|Total|Total of all reporting groups
11219424|NCT02326649|FG000|Participant Flow|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
11219425|NCT02326649|OG000|Outcome|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
11219426|NCT02326649|EG000|Reported Event|CHD Patients Undergoing Cardiac MRI Without Sedation|Physioflow: impedance cardiography instrument that measures cardiac output non-invasively
11219427|NCT02326805|BG000|Baseline|Arm I (Rilimogene-galvacirepvec)|"Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Rilimogene Galvacirepvec: Given SC"
11219428|NCT02326805|BG001|Baseline|Arm II (Placebo)|"Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given SC"
11219429|NCT02326805|BG002|Baseline|Total|Total of all reporting groups
11219430|NCT02326805|FG000|Participant Flow|Arm I (Rilimogene-galvacirepvec)|"Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Rilimogene Galvacirepvec: Given SC"
11219431|NCT02326805|FG001|Participant Flow|Arm II (Placebo)|"Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given SC"
11219432|NCT02326805|OG000|Outcome|Arm I (Rilimogene-galvacirepvec)|"Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Rilimogene Galvacirepvec: Given SC"
11219433|NCT02326805|OG001|Outcome|Arm II (Placebo)|"Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given SC"
11219434|NCT02326805|EG000|Reported Event|Arm I (Rilimogene-galvacirepvec)|"Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Rilimogene Galvacirepvec: Given SC"
11219435|NCT02326805|EG001|Reported Event|Arm II (Placebo)|"Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given SC"
11219436|NCT02326844|BG000|Baseline|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
11219437|NCT02326844|FG000|Participant Flow|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
11219438|NCT02326844|OG000|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
11219439|NCT02326844|EG000|Reported Event|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
11219440|NCT02326883|BG000|Baseline|Care Management|"The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).~Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary)."
11219441|NCT02326883|BG001|Baseline|Skills Training|"The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.~Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills."
11219442|NCT02326883|BG002|Baseline|Usual Care|"Those assigned to the Usual Care group will not be approached or contacted.~Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers."
11219443|NCT02326883|BG003|Baseline|Total|Total of all reporting groups
11219444|NCT02326883|FG000|Participant Flow|Care Management|"The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).~Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary)."
11333827|NCT03520387|FG000|Participant Flow|Pre-Randomization Run-In Period|The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized.
11219445|NCT02326883|FG001|Participant Flow|Skills Training|"The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.~Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills."
11219446|NCT02326883|FG002|Participant Flow|Usual Care|"Those assigned to the Usual Care group will not be approached or contacted.~Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers."
11219447|NCT02326883|OG000|Outcome|Care Management|"The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).~Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary)."
11219448|NCT02326883|OG001|Outcome|Skills Training|"The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.~Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills."
11219449|NCT02326883|OG002|Outcome|Usual Care|"Those assigned to the Usual Care group will not be approached or contacted.~Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers."
11219450|NCT02326883|EG000|Reported Event|Care Management|"The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).~Care Management: The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary)."
11219451|NCT02326883|EG001|Reported Event|Skills Training|"The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.~Skills Training: The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills."
11219452|NCT02326883|EG002|Reported Event|Usual Care|"Those assigned to the Usual Care group will not be approached or contacted.~Usual Care: Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers."
11219453|NCT02327013|BG000|Baseline|Placebo (Stage 1)|Patients treated wtih placebo in Stage 1.
11219454|NCT02327013|BG001|Baseline|Vortioxetine 10mg (Stage 1)|Patients treated with vortioxetine 10mg in Stage 1.
11219455|NCT02327013|BG002|Baseline|Vortioxetine 20mg (Stage 1)|Patients treated with vortioxetine 20mg in Stage 1.
11219456|NCT02327013|BG003|Baseline|Total|Total of all reporting groups
11219457|NCT02327013|FG000|Participant Flow|Vortioxetine 10mg|Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2.
11219458|NCT02327013|FG001|Participant Flow|Vortioxetine 20mg|Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2.
11219459|NCT02327013|FG002|Participant Flow|Placebo - Placebo|Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group will consist of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
11219460|NCT02327013|FG003|Participant Flow|Placebo - Vortioxetine 10mg|Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.
11219461|NCT02327013|FG004|Participant Flow|Placebo - Vortioxetine 20mg|Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2.
11219462|NCT02327013|OG000|Outcome|Placebo, Stage 1|Patients treated with placebo in Stage 1.
11219463|NCT02327013|OG001|Outcome|Vortioxetine 10mg, Stage 1|Patients treated with vortioxetine 10mg in Stage 1.
11219464|NCT02327013|OG002|Outcome|Vortioxetine 20mg, Stage 1|Patients treated with vortioxetine 20mg in Stage 1.
11219465|NCT02327013|OG003|Outcome|Placebo, Stage 2|Placebo responders from Stage 1 continue on placebo in Stage 2.
11219466|NCT02327013|OG004|Outcome|Vortioxetine 10mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
11219467|NCT02327013|OG005|Outcome|Vortioxetine 20mg, Stage 2|Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
10834507|NCT00162266|OG000|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
10834508|NCT00162266|OG001|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DBperiod received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately weight-tiered dose of abatacept 10 mg/kg.
10834509|NCT00162266|EG000|Reported Event|Aba 10mg/kg+MTX|
10834510|NCT00162266|EG001|Reported Event|Aba 2mg/kg+MTX|
10834511|NCT00162266|EG002|Reported Event|Abatacept (LT)|
10834512|NCT00162266|EG003|Reported Event|Placebo+MTX|
10834513|NCT00162981|BG000|Baseline|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
10834514|NCT00162981|BG001|Baseline|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
10834515|NCT00162981|BG002|Baseline|Total|Total of all reporting groups
10834516|NCT00162981|FG000|Participant Flow|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
10834517|NCT00162981|FG001|Participant Flow|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
10834518|NCT00162981|OG000|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
10834519|NCT00162981|OG001|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
10834520|NCT00162981|EG000|Reported Event|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
10834521|NCT00162981|EG001|Reported Event|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
10834522|NCT00163020|BG000|Baseline|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
10834523|NCT00163020|BG001|Baseline|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
10834524|NCT00163020|BG002|Baseline|Total|Total of all reporting groups
10834525|NCT00163020|FG000|Participant Flow|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
10834526|NCT00163020|FG001|Participant Flow|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
10834527|NCT00163020|OG000|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
10834528|NCT00163020|OG001|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
10834529|NCT00163020|OG000|Outcome|Triplet Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
10834530|NCT00163020|OG001|Outcome|Triplet Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
10834531|NCT00163020|EG000|Reported Event|Test Group (170HP)|Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
10834532|NCT00163020|EG001|Reported Event|Control (Castor Oil)|Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
10834533|NCT00163189|BG000|Baseline|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
10834534|NCT00163189|FG000|Participant Flow|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
10834535|NCT00163189|OG000|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
10834536|NCT00163189|EG000|Reported Event|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
10834537|NCT00163215|BG000|Baseline|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
10834538|NCT00163215|FG000|Participant Flow|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
10834539|NCT00163215|OG000|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
10834540|NCT00163215|EG000|Reported Event|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
10834541|NCT00163293|BG000|Baseline|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834542|NCT00163293|BG001|Baseline|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834543|NCT00163293|BG002|Baseline|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834544|NCT00163293|BG003|Baseline|Total|Total of all reporting groups
10834545|NCT00163293|FG000|Participant Flow|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834546|NCT00163293|FG001|Participant Flow|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834547|NCT00163293|FG002|Participant Flow|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
11219468|NCT02327013|OG006|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
11219469|NCT02327013|OG007|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
11219470|NCT02327013|OG008|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
11219471|NCT02327013|OG000|Outcome|Placebo, Combined|Combined data from patients treated with placebo in Stage 1 and 2
11219472|NCT02327013|OG001|Outcome|Vortioxetine 10mg, Combined|Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
11219473|NCT02327013|OG002|Outcome|Vortioxetine 20mg, Combined|Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
11219474|NCT02327013|OG000|Outcome|Placebo, Stage 1|Data from patients treated with placebo in Stage
11219475|NCT02327013|OG001|Outcome|Vortioxetine 10mg, Stage 1|Data from patients treated with vortioxetine 10mg in Stage 1
11219476|NCT02327013|OG002|Outcome|Vortioxetine 20mg, Stage 1|Data from patients treated with vortioxetine 20mg in Stage 1
11219477|NCT02327013|EG000|Reported Event|Placebo-Placebo|Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group consists of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
11219478|NCT02327013|EG001|Reported Event|Vortioxetine 10mg|Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.This group consists of patients who had received dosing of 10 mg vortioxetine in the study.
11219479|NCT02327013|EG002|Reported Event|Vortioxetine 20mg|Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2. This group consists of patients who had received dosing of 20 mg vortioxetine in the study.
11219480|NCT02327052|BG000|Baseline|Chagas Disease|See below Baseline Measures
11219481|NCT02327052|FG000|Participant Flow|Chagas Disease|The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests, from a convenience sample.
11219482|NCT02327052|OG000|Outcome|Chagas Disease|The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests.
11219483|NCT02327052|EG000|Reported Event|Chagas Disease|No intervention was performed and we conducted a cross-sectional study, therefore there were no adverse events.
11219484|NCT02327117|BG000|Baseline|Tranexamic Acid|Tranexamic Acid
11219485|NCT02327117|BG001|Baseline|Normal Saline|Normal saline
11219486|NCT02327117|BG002|Baseline|Total|Total of all reporting groups
11219487|NCT02327117|FG000|Participant Flow|Tranexamic Acid|Tranexamic Acid
11219488|NCT02327117|FG001|Participant Flow|Normal Saline|Normal saline
11219489|NCT02327117|OG000|Outcome|Tranexamic Acid|Tranexamic Acid
11219490|NCT02327117|OG001|Outcome|Normal Saline|Normal saline
11219491|NCT02327117|EG000|Reported Event|Tranexamic Acid|Tranexamic Acid
11219492|NCT02327117|EG001|Reported Event|Normal Saline|Normal saline
11219493|NCT02327130|BG000|Baseline|Critically Ill Subjects at Risk for Infection|Critically ill adult ICU subjects who are not suspected of having an infection at the time of ICU admission were enrolled as study subjects.
11219494|NCT02327130|FG000|Participant Flow|Isomark Canary|All subjects were enrolled were at risk for developing infections during the study but did not currently exhibit signs of ongoing infection. The 'at risk' enrolled subjects utilized the Isomark Canary to take exhaled breath samples to assess for infection status.
11219495|NCT02327130|OG000|Outcome|Exhaled Breath|Exhaled breath samples were collected 6 times per day for 7 days. We will use the Isomark Canary™ to determine the BDV of breath samples collected during this study.
11219496|NCT02327130|OG000|Outcome|Infection Diagnosis|An endpoint adjudication committee (EAC), composed of three independent senior infectious disease experts, not involved in the subject clinical care, reviewed each study subjects' data to determine the clinical time and date of infection. Each EAC member independently reviewed the subject cases and completed the EAC Infection Status case report form. In cases where an infection developed the EAC placed a time and date stamp for time of first suspicion of infection and confirmation based on clinical judgement culture, or diagnostic imaging.
11219497|NCT02327130|OG000|Outcome|Sensitivity|Percent sensitivity for BDV to predict an infection
11219498|NCT02327130|OG001|Outcome|Specificity|Percent specificity for BDV to predict an infection
11219499|NCT02327130|EG000|Reported Event|At Risk for Infection|All subjects were enrolled were at risk for developing infections during the study but did not currently exhibit signs of ongoing infection.
11219500|NCT02327143|BG000|Baseline|All Participants|200 mg LY2835219 administered orally on day 1. 0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose on day 1.
11219501|NCT02327143|FG000|Participant Flow|200 mg LY2835219|200 mg LY2835219 administered orally on day 1.
11219502|NCT02327143|FG001|Participant Flow|200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219|0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose on day 1.
11219503|NCT02327143|OG000|Outcome|200 mg LY2835219|200 mg LY2835219 administered orally on day 1.
11219504|NCT02327143|OG001|Outcome|200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219|0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
11219505|NCT02327143|EG000|Reported Event|200 mg LY2835219|200 mg LY2835219 administered orally on day 1.
11219506|NCT02327143|EG001|Reported Event|200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219|0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
11219507|NCT02327169|BG000|Baseline|MLN2480 100 mg + MLN0128 2 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and MLN0128 2 mg, capsules, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles.
11219508|NCT02327169|BG001|Baseline|MLN2480 100 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219509|NCT02327169|BG002|Baseline|MLN2480 160 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219510|NCT02327169|BG003|Baseline|MLN2480 200 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219511|NCT02327169|BG004|Baseline|MLN2480 100 mg + Alisertib 40 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219512|NCT02327169|BG005|Baseline|MLN2480 100 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219513|NCT02327169|BG006|Baseline|MLN2480 160 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219514|NCT02327169|BG007|Baseline|MLN2480 200 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219515|NCT02327169|BG008|Baseline|MLN2480 400 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219516|NCT02327169|BG009|Baseline|MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219517|NCT02327169|BG010|Baseline|MLN2480 400 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219518|NCT02327169|BG011|Baseline|MLN2480 600 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219519|NCT02327169|BG012|Baseline|ML2480 300 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 300 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219520|NCT02327169|BG013|Baseline|ML2480 400 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219521|NCT02327169|BG014|Baseline|Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles.
11219522|NCT02327169|BG015|Baseline|Total|Total of all reporting groups
11219523|NCT02327169|FG000|Participant Flow|MLN2480 100 mg + MLN0128 2 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and MLN0128 2 mg, capsules, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles.
11219524|NCT02327169|FG001|Participant Flow|MLN2480 100 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219525|NCT02327169|FG002|Participant Flow|MLN2480 160 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219526|NCT02327169|FG003|Participant Flow|MLN2480 200 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219527|NCT02327169|FG004|Participant Flow|MLN2480 100 mg + Alisertib 40 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219528|NCT02327169|FG005|Participant Flow|MLN2480 100 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219529|NCT02327169|FG006|Participant Flow|MLN2480 160 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219530|NCT02327169|FG007|Participant Flow|MLN2480 200 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219531|NCT02327169|FG008|Participant Flow|MLN2480 400 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219532|NCT02327169|FG009|Participant Flow|MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219533|NCT02327169|FG010|Participant Flow|MLN2480 400 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219534|NCT02327169|FG011|Participant Flow|MLN2480 600 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219535|NCT02327169|FG012|Participant Flow|ML2480 300 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 300 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219536|NCT02327169|FG013|Participant Flow|ML2480 400 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219537|NCT02327169|FG014|Participant Flow|Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles.
11219538|NCT02327169|OG000|Outcome|MLN2480 100 mg + MLN0128 2 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and MLN0128 2 mg, capsules, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles.
11219539|NCT02327169|OG001|Outcome|MLN2480 100 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219540|NCT02327169|OG002|Outcome|MLN2480 160 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219541|NCT02327169|OG003|Outcome|MLN2480 200 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219542|NCT02327169|OG004|Outcome|MLN2480 100 mg + Alisertib 40 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219543|NCT02327169|OG005|Outcome|MLN2480 100 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219544|NCT02327169|OG006|Outcome|MLN2480 160 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219545|NCT02327169|OG007|Outcome|MLN2480 200 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219546|NCT02327169|OG008|Outcome|MLN2480 400 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219547|NCT02327169|OG009|Outcome|MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219548|NCT02327169|OG010|Outcome|MLN2480 400 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219549|NCT02327169|OG011|Outcome|MLN2480 600 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219550|NCT02327169|OG012|Outcome|ML2480 300 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 300 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219551|NCT02327169|OG013|Outcome|ML2480 400 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219552|NCT02327169|OG014|Outcome|Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles.
11219553|NCT02327169|OG000|Outcome|MLN2480 100 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219554|NCT02327169|OG001|Outcome|MLN2480 160 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219555|NCT02327169|OG002|Outcome|MLN2480 200 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219556|NCT02327169|OG003|Outcome|MLN2480 100 mg + Alisertib 40 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219557|NCT02327169|OG000|Outcome|MLN2480 100 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219558|NCT02327169|OG001|Outcome|MLN2480 160 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219559|NCT02327169|OG002|Outcome|MLN2480 200 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219560|NCT02327169|OG003|Outcome|MLN2480 400 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219561|NCT02327169|OG004|Outcome|MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219562|NCT02327169|OG005|Outcome|Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg, capsules, orally, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles.
11219563|NCT02327169|EG000|Reported Event|MLN2480 100 mg + MLN0128 2 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and MLN0128 2 mg, capsules, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles.
11219564|NCT02327169|EG001|Reported Event|MLN2480 100 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219565|NCT02327169|EG002|Reported Event|MLN2480 160 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219566|NCT02327169|EG003|Reported Event|MLN2480 200 mg + Alisertib 30 mg|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219567|NCT02327169|EG004|Reported Event|MLN2480 100 mg + Alisertib 40 mg|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle.
11219568|NCT02327169|EG005|Reported Event|MLN2480 100 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219569|NCT02327169|EG006|Reported Event|MLN2480 160 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219570|NCT02327169|EG007|Reported Event|MLN2480 200 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219571|NCT02327169|EG008|Reported Event|MLN2480 400 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
11219572|NCT02327169|EG009|Reported Event|MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care.
10834548|NCT00163293|OG000|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834549|NCT00163293|OG001|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834550|NCT00163293|OG002|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834551|NCT00163293|EG000|Reported Event|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834552|NCT00163293|EG001|Reported Event|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834553|NCT00163293|EG002|Reported Event|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
10834554|NCT00163657|BG000|Baseline|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
10834555|NCT00163657|BG001|Baseline|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
10834556|NCT00163657|BG002|Baseline|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
10834557|NCT00163657|BG003|Baseline|Total|Total of all reporting groups
10834558|NCT00163657|FG000|Participant Flow|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
10834559|NCT00163657|FG001|Participant Flow|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
10834560|NCT00163657|FG002|Participant Flow|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
10834561|NCT00163657|OG000|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
10834562|NCT00163657|OG001|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
10834563|NCT00163657|OG002|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
10834564|NCT00163657|EG000|Reported Event|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
10834565|NCT00163657|EG001|Reported Event|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
10834566|NCT00163657|EG002|Reported Event|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
10834567|NCT00165646|BG000|Baseline|Placebo|once daily orally for 4 weeks
10834568|NCT00165646|BG001|Baseline|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
10834569|NCT00165646|BG002|Baseline|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
10834570|NCT00165646|BG003|Baseline|Total|Total of all reporting groups
10834571|NCT00165646|FG000|Participant Flow|Placebo|once daily orally for 4 weeks
10834572|NCT00165646|FG001|Participant Flow|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
10834573|NCT00165646|FG002|Participant Flow|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
10834574|NCT00165646|OG000|Outcome|Placebo|once daily orally for 4 weeks
10834575|NCT00165646|OG001|Outcome|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
10834576|NCT00165646|OG002|Outcome|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
10834577|NCT00165646|EG000|Reported Event|Placebo|once daily orally for 4 weeks
10834578|NCT00165646|EG001|Reported Event|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
10834579|NCT00165646|EG002|Reported Event|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
10834580|NCT00165672|BG000|Baseline|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
10834581|NCT00165672|BG001|Baseline|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
10834582|NCT00165672|BG002|Baseline|Total|Total of all reporting groups
10834583|NCT00165672|FG000|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
10834584|NCT00165672|FG001|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
10834585|NCT00165672|OG000|Outcome|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
10834586|NCT00165672|OG001|Outcome|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
10834587|NCT00165672|EG000|Reported Event|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
10834588|NCT00165672|EG001|Reported Event|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
10834589|NCT00165698|BG000|Baseline|Menatetrenone|15 mg t.i.d. orally for 12 months
10834590|NCT00165698|BG001|Baseline|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
10834591|NCT00165698|BG002|Baseline|Total|Total of all reporting groups
10834592|NCT00165698|FG000|Participant Flow|Menatetrenone|15 mg t.i.d. orally for 12 months
10834593|NCT00165698|FG001|Participant Flow|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
10834594|NCT00165698|OG000|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
10834595|NCT00165698|OG001|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
10834596|NCT00165698|EG000|Reported Event|Menatetrenone|15 mg t.i.d. orally for 12 months
10834597|NCT00165698|EG001|Reported Event|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
10834598|NCT00165776|BG000|Baseline|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
10834599|NCT00165776|BG001|Baseline|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834600|NCT00165776|BG002|Baseline|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
10834601|NCT00165776|BG003|Baseline|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834602|NCT00165776|BG004|Baseline|Total|Total of all reporting groups
10834603|NCT00165776|FG000|Participant Flow|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
11219573|NCT02327169|EG010|Reported Event|MLN2480 400 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219574|NCT02327169|EG011|Reported Event|MLN2480 600 mg + Cetuximab 250 mg/m^2|Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m^2 (cycle 1 Day 1), then at 250 mg/m^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care.
11219575|NCT02327169|EG012|Reported Event|ML2480 300 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 300 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219576|NCT02327169|EG013|Reported Event|ML2480 400 mg + Irinotecan 180 mg/m^2|Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care.
11219577|NCT02327169|EG014|Reported Event|Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2|Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m^2, IV infusion, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles.
11219578|NCT02327260|BG000|Baseline|Video + MI for CR|"This group receives the educational video and an MI session for CR participation.~Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR."
11219579|NCT02327260|BG001|Baseline|MI for Medication Adherence|"This group receives an MI session for taking prescribed cardioprotective medications,~Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications."
11219580|NCT02327260|BG002|Baseline|Control Group (Standard Care)|This group received standard care following a cardiac procedure.
11219581|NCT02327260|BG003|Baseline|Total|Total of all reporting groups
11219582|NCT02327260|FG000|Participant Flow|Video + MI for CR|"This group receives the educational video and an MI session for CR participation.~Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR."
11219583|NCT02327260|FG001|Participant Flow|MI for Medication Adherence|"This group receives an MI session for taking prescribed cardioprotective medications,~Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications."
11219584|NCT02327260|FG002|Participant Flow|Control Group (Standard Care)|This is the standard of care group. It received typical care by hospital staff following a cardiac procedure.
11219585|NCT02327260|OG000|Outcome|Video + MI for CR|"This group receives the educational video and an MI session for CR participation.~Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR."
11219586|NCT02327260|OG001|Outcome|MI for Medication Adherence|"This group receives an MI session for taking prescribed cardioprotective medications,~Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications."
11219587|NCT02327260|OG002|Outcome|Control Group (Standard Care)|This group received standard care following a cardiac procedure.
11219588|NCT02327260|OG002|Outcome|Control Group (Standard Care)|This is the standard of care group. It received typical care by hospital staff following a cardiac procedure.
11219589|NCT02327260|EG000|Reported Event|Video + MI for CR|"This group receives the educational video and an MI session for CR participation.~Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR."
10834604|NCT00165776|FG001|Participant Flow|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
11219590|NCT02327260|EG001|Reported Event|MI for Medication Adherence|"This group receives an MI session for taking prescribed cardioprotective medications,~Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications."
11219591|NCT02327260|EG002|Reported Event|Control Group (Standard Care)|This group received standard care following a cardiac procedure.
10834605|NCT00165776|FG002|Participant Flow|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834606|NCT00165776|FG003|Participant Flow|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
11219592|NCT02327325|BG000|Baseline|Physical Activity Only|"12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity."
11219593|NCT02327325|BG001|Baseline|Physical Activity + Cognitive Behavioral Therapy|"12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain."
11219594|NCT02327325|BG002|Baseline|Wait List Control Group|Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
11219595|NCT02327325|BG003|Baseline|Total|Total of all reporting groups
11219596|NCT02327325|FG000|Participant Flow|Physical Activity Only|"12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity."
11219597|NCT02327325|FG001|Participant Flow|Physical Activity + Cognitive Behavioral Therapy|"12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain."
11219598|NCT02327325|FG002|Participant Flow|Wait List Control Group|Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
11219599|NCT02327325|OG000|Outcome|Physical Activity Only|"12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity."
11219600|NCT02327325|OG001|Outcome|Physical Activity + Cognitive Behavioral Therapy|"12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain."
11219601|NCT02327325|OG002|Outcome|Wait List Control Group|Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
11219602|NCT02327325|EG000|Reported Event|Physical Activity Only|"12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity."
11219603|NCT02327325|EG001|Reported Event|Physical Activity + Cognitive Behavioral Therapy|"12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.~Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.~Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain."
11219604|NCT02327325|EG002|Reported Event|Wait List Control Group|Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
11219605|NCT02327351|BG000|Baseline|TCR Alfa Beta Depletion|"TCR alfa beta depleted graft, infusion. The leukapheresis product will undergo TCR alfa beta depletion following the standardized protocol.~Biological: TCR alfa beta T cell depletion"
11219606|NCT02327351|FG000|Participant Flow|TCR Alfa Beta Depletion|"TCR alfa beta depleted graft, infusion. The leukapheresis product will undergo TCR alfa beta depletion following the standardized protocol.~Biological: TCR alfa beta T cell depletion"
11219607|NCT02327351|OG000|Outcome|TCR Alfa Beta Depletion|"TCR alfa beta depleted graft, infusion. The leukapheresis product will undergo TCR alfa beta depletion following the standardized protocol.~Biological: TCR alfa beta T cell depletion"
11219608|NCT02327351|OG001|Outcome|Matched Unrelated Donor|type of HSCT donor - HLA-matched unrelated donor
11219609|NCT02327351|OG002|Outcome|HLA-mismatched Related Donor|type of HSCT donor - HLA-mismatched related
11219610|NCT02327351|OG000|Outcome|Matched Unrelated Donor|donor type - HLA-matched unrelated donor
11219611|NCT02327351|OG001|Outcome|Mismatched Related Donors|donor type - HLA-mismatch relative
11219612|NCT02327351|EG000|Reported Event|TCR Alfa Beta Depletion|"TCR alfa beta depleted graft, infusion. The leukapheresis product will undergo TCR alfa beta depletion following the standardized protocol.~Biological: TCR alfa beta T cell depletion"
10834607|NCT00165776|OG000|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
10834608|NCT00165776|OG001|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834609|NCT00165776|OG002|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834610|NCT00165776|OG003|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834611|NCT00165776|EG000|Reported Event|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
10834612|NCT00165776|EG001|Reported Event|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834613|NCT00165776|EG002|Reported Event|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834614|NCT00165776|EG003|Reported Event|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
10834615|NCT00165789|BG000|Baseline|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834616|NCT00165789|BG001|Baseline|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
10834617|NCT00165789|BG002|Baseline|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834618|NCT00165789|BG003|Baseline|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
10834619|NCT00165789|BG004|Baseline|Total|Total of all reporting groups
10834620|NCT00165789|FG000|Participant Flow|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834621|NCT00165789|FG001|Participant Flow|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
10834622|NCT00165789|FG002|Participant Flow|Cohort 2- Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834623|NCT00165789|FG003|Participant Flow|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
10834624|NCT00165789|OG000|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834625|NCT00165789|OG001|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
10834626|NCT00165789|OG002|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834627|NCT00165789|OG003|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
10834628|NCT00165789|EG000|Reported Event|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834629|NCT00165789|EG001|Reported Event|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
10834630|NCT00165789|EG002|Reported Event|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
10834631|NCT00165789|EG003|Reported Event|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
10834632|NCT00165841|BG000|Baseline|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
10834633|NCT00165841|BG001|Baseline|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
10834634|NCT00165841|BG002|Baseline|Total|Total of all reporting groups
10834635|NCT00165841|FG000|Participant Flow|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
10834636|NCT00165841|FG001|Participant Flow|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
10834637|NCT00165841|OG000|Outcome|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
10834638|NCT00165841|OG001|Outcome|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
10834639|NCT00165841|EG000|Reported Event|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
10834640|NCT00165841|EG001|Reported Event|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
10834641|NCT00165958|BG000|Baseline|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
10834642|NCT00165958|BG001|Baseline|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
10834643|NCT00165958|BG002|Baseline|Total|Total of all reporting groups
10834644|NCT00165958|FG000|Participant Flow|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
10834645|NCT00165958|FG001|Participant Flow|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
10834646|NCT00165958|OG000|Outcome|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
10834647|NCT00165958|OG001|Outcome|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
10834648|NCT00165958|EG000|Reported Event|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
11219613|NCT02327429|BG000|Baseline|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
11219614|NCT02327429|FG000|Participant Flow|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
11219615|NCT02327429|OG000|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
11219616|NCT02327429|EG000|Reported Event|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study~A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
11219617|NCT02327741|BG000|Baseline|Plavix Long Term|"taking plavix more than 12 months~plavix: taking plavix more than 12 months"
11219618|NCT02327741|BG001|Baseline|Plavix Short Term|"taking plavix less than 12 months~plavix: taking plavix less than 12 months"
11219619|NCT02327741|BG002|Baseline|Total|Total of all reporting groups
11219620|NCT02327741|FG000|Participant Flow|Plavix Short Term|"taking plavix less than 12 months~plavix: taking plavix less than 12 months"
11219621|NCT02327741|FG001|Participant Flow|Plavix Long Term|"taking plavix more than 12 months~plavix: taking plavix more than 12 months"
11219622|NCT02327741|OG000|Outcome|Plavix Short Term|taking plavix less than 12 months
11219623|NCT02327741|OG001|Outcome|Plavix Long Term|taking plavix more than 12 months
11219624|NCT02327741|EG000|Reported Event|Plavix Short Term|taking plavix less than 12 months
11219625|NCT02327741|EG001|Reported Event|Plavix Long Term|taking plavix more than 12 months
11219626|NCT02328027|BG000|Baseline|99mTc-rhAnnexin V-128: Ankylosing Spondylitis|Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219627|NCT02328027|BG001|Baseline|99mTc-rhAnnexin V-128: Rheumatoid Arthritis|Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219628|NCT02328027|BG002|Baseline|Total|Total of all reporting groups
11219629|NCT02328027|FG000|Participant Flow|99mTc-rhAnnexin V-128: Ankylosing Spondylitis|Participants with Ankylosing Spondylitis (AS) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 Megabecquerel (MBq) through an intravenous (IV) catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219630|NCT02328027|FG001|Participant Flow|99mTc-rhAnnexin V-128: Rheumatoid Arthritis|Participants with Rheumatoid Arthritis (RA) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219631|NCT02328027|OG000|Outcome|99mTc-rhAnnexin V-128: Ankylosing Spondylitis|Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219632|NCT02328027|OG001|Outcome|99mTc-rhAnnexin V-128: Rheumatoid Arthritis|Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219633|NCT02328027|OG000|Outcome|99mTc-rhAnnexin V-128: AS and RA|Participants with AS and RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219634|NCT02328027|EG000|Reported Event|99mTc-rhAnnexin V-128: Ankylosing Spondylitis|Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219635|NCT02328027|EG001|Reported Event|99mTc-rhAnnexin V-128: Rheumatoid Arthritis|Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
11219636|NCT02328040|BG000|Baseline|All Study Participants|Participants who were randomized to receive either Placebo/Insulin Participants, placebo orally and Insulin subcutaneously or Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously.
11219637|NCT02328040|FG000|Participant Flow|Placebo/Insulin First, Then Sitagliptin/Insulin|Participants first received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days. Then they received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.
11219638|NCT02328040|FG001|Participant Flow|Sitagliptin/Insulin First, Then Placebo/Insulin|Participants first received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for the next 2 days. Then they received Placebo/Insulin, placebo orally and Insulin subcutaneously for the next 2 days. Each visit is 3-4 weeks apart.
11219639|NCT02328040|OG000|Outcome|Placebo/Insulin|Participants who received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days.
11219640|NCT02328040|OG001|Outcome|Sitagliptin/Insulin|Participants who received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for 2 days.
11219641|NCT02328040|EG000|Reported Event|Placebo/Insulin|Participants who received Placebo/Insulin, placebo orally and Insulin subcutaneously for 2 days.
11219642|NCT02328040|EG001|Reported Event|Siatagliptin/Insulin|Participants who received Sitagliptin/Insulin, 100 mg of Sitagliptin orally and insulin subcutaneously for 2 days.
11219643|NCT02328326|BG000|Baseline|CO-IMPACT|"patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns~CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter"
11219644|NCT02328326|BG001|Baseline|PACT|"patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits~PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits"
11219645|NCT02328326|BG002|Baseline|Total|Total of all reporting groups
11219646|NCT02328326|FG000|Participant Flow|CO-IMPACT|"patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns~CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter"
11219647|NCT02328326|FG001|Participant Flow|PACT|"patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits~PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits"
11219648|NCT02328326|OG000|Outcome|CO-IMPACT|"patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns~CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter."
11219649|NCT02328326|OG001|Outcome|PACT|"patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format.~PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits."
11219650|NCT02328326|OG000|Outcome|CO-IMPACT|"patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns~CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter"
11219651|NCT02328326|OG001|Outcome|PACT|"patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits~PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits"
11219652|NCT02328326|EG000|Reported Event|CO-IMPACT|"patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns~CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter"
11219653|NCT02328326|EG001|Reported Event|PACT|"patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits~PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits"
11219654|NCT02328404|BG000|Baseline|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219655|NCT02328404|BG001|Baseline|Placebo (Biodal 50,000IU Placebo)|"Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route~Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months"
11219656|NCT02328404|BG002|Baseline|Total|Total of all reporting groups
11219657|NCT02328404|FG000|Participant Flow|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219658|NCT02328404|FG001|Participant Flow|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
11219659|NCT02328404|OG000|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219660|NCT02328404|OG001|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
11219661|NCT02328404|OG001|Outcome|Placebo|"Placebo coated tablet by oral route~Placebo: placebo coated tablet by oral route"
11219662|NCT02328404|OG000|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219663|NCT02328404|OG000|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219664|NCT02328404|OG001|Outcome|Placebo|"placebo coated tablet by oral route~placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months"
11219665|NCT02328404|EG000|Reported Event|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
11219666|NCT02328404|EG001|Reported Event|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
11219667|NCT02328547|BG000|Baseline|Fecal Microbiota Transplantation Capsules First, Then Placebo|"Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).~FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA."
11219668|NCT02328547|BG001|Baseline|Placebo Capsules First, Then Fecal Microbiota Transplantation|"Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).~FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA."
11219669|NCT02328547|BG002|Baseline|Total|Total of all reporting groups
11219670|NCT02328547|FG000|Participant Flow|Fecal Microbiota Transplantation Capsules First, Then Placebo|"Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. Patients were crossed-over into the Placebo arm at 12 weeks. After cross-over, patients were administered 25 Placebo capsules, that did not contain donor stool or active drug, on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo dosing. The overall duration of the study was 6 months.~FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA."
11219671|NCT02328547|FG001|Participant Flow|Placebo Capsules First, Then Fecal Microbiota Transplantation|"Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo administration. Patients were then crossed-over into the FMT arm at 12 weeks. After cross-over, patients were administered 25 Fecal Microbiota Transplantation (FMT) capsules on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. The overall duration of the study was 6 months.~FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA."
11219672|NCT02328547|OG000|Outcome|FMT Capsules, Followed by Placebo Capsules|Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
11219673|NCT02328547|OG001|Outcome|Placebo Capsules, Followed by FMT Capsules|Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
11219674|NCT02328547|OG000|Outcome|FMT Responders|Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
11219675|NCT02328547|OG001|Outcome|FMT Non-responders|Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
11219676|NCT02328547|OG000|Outcome|FMT Capsules|Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) either at the start of the trial or at cross-over (week 12).
11219677|NCT02328547|OG001|Outcome|Placebo Capsules|Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) at the start of the trial or at cross-over (week 12).
11219678|NCT02328547|OG000|Outcome|FMT Capsules, Followed by Placebo Capsules|Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
11219679|NCT02328547|OG001|Outcome|Placebo Capsules, Followed by FMT Capsules|Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
10834649|NCT00165958|EG001|Reported Event|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
10834650|NCT00165984|BG000|Baseline|Single Ventricle Patients|Patients born with single ventricle heart disease
10834651|NCT00165984|FG000|Participant Flow|Single Ventricle Patients|Patients born with single ventricle heart disease
10834652|NCT00165984|OG000|Outcome|Incidence of Preproendothelin-1 5665 Polymorphism|Incidence of Homozygosity for mutation at nucleotide 5665
10834653|NCT00165984|OG000|Outcome|Preproendothelin-1 (ppET1) 5665 Polymorphism Homozygotes|Transplant-free survival for patients homozygous for T at nucleotide 5665 at 7 years.
10834654|NCT00165984|OG001|Outcome|Homozygous for Wild-type ppET1 5665|Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.
10834655|NCT00165984|OG002|Outcome|Heterozygotes|Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
10834656|NCT00165984|EG000|Reported Event|Single Ventricle Patients|Patients born with single ventricle heart disease
10834657|NCT00166036|BG000|Baseline|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
10834658|NCT00166036|BG001|Baseline|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
10834659|NCT00166036|BG002|Baseline|Total|Total of all reporting groups
10834660|NCT00166036|FG000|Participant Flow|Atorvastatin 10 mg|Once Daily for 12 Weeks
10834661|NCT00166036|FG001|Participant Flow|Pravastatin 80 mg|Once Daily for 12 Weeks
10834662|NCT00166036|OG000|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg taken daily
10834663|NCT00166036|OG001|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
10834664|NCT00166036|OG000|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg daily
10834665|NCT00166036|EG000|Reported Event|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
10834666|NCT00166036|EG001|Reported Event|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
10834667|NCT00166114|BG000|Baseline|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
10834668|NCT00166114|BG001|Baseline|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
10834669|NCT00166114|BG002|Baseline|Total|Total of all reporting groups
10834670|NCT00166114|FG000|Participant Flow|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
10834671|NCT00166114|FG001|Participant Flow|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
10834672|NCT00166114|OG000|Outcome|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
10834673|NCT00166114|OG001|Outcome|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
10834674|NCT00166114|EG000|Reported Event|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
10834675|NCT00166114|EG001|Reported Event|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
10834676|NCT00166166|BG000|Baseline|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834677|NCT00166166|BG001|Baseline|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834678|NCT00166166|BG002|Baseline|Total|Total of all reporting groups
10834679|NCT00166166|FG000|Participant Flow|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834680|NCT00166166|FG001|Participant Flow|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834681|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).
10834682|NCT00166166|OG001|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)
10834683|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
10834684|NCT00166166|OG001|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
10834685|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.
10834686|NCT00166166|OG001|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole
10834687|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole
10834688|NCT00166166|OG001|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole
11219680|NCT02328547|EG000|Reported Event|FMT Capsules|"25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12).~FMT capsules contained extensively screened donor stool and were prepared by OpenBiome, Medford, MA."
11219681|NCT02328547|EG001|Reported Event|Placebo Capsules|"25 placebo capsules, that did not contain donor stool or any active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12).~Placebo capsules contained saline and glycerol. ann were prepared by OpenBiome, Medford, MA."
11219682|NCT02328755|BG000|Baseline|Dose Level 1 - 90 mcg Peg-IFN-α|Dose Level 1 - 90 mcg peg-IFN-α administered prior to hematopoietic cell transplant (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days beginning with dose level 1.
11219683|NCT02328755|BG001|Baseline|Dose Level 2 - 180 mcg Peg-IFN-α|Dose Level 2 - 180 mcg peg-IFN-α administered prior to hematopoietic cell transplant (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days beginning with dose level 1.
11219684|NCT02328755|BG002|Baseline|Total|Total of all reporting groups
11219685|NCT02328755|FG000|Participant Flow|Dose Level 1, 90 mcg Peg-IFN-α|90 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219686|NCT02328755|FG001|Participant Flow|Dose Level 2, 180 mcg Peg-IFN-α|180 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219687|NCT02328755|OG000|Outcome|Peg-IFN-α|"peg-IFN-α was administered prior to HCT (Hematopoietic Cell Transplant) and at three subsequent time points post HCT. (Maximum of 4 doses) It was administered by subcutaneous injection every 14 days beginning with dose level 1.~Dose Level -1 - 45mcg Dose Level 1 - 90mcg Dose Level 2 - 180 mcg peg-IFN-α It was begun at 90 mcg, would have been reduced back to 45 mcg if necessary, and after 3 participants it was increased to 180 mcg."
11219688|NCT02328755|OG000|Outcome|Dose Level 1 - 90 mg Peg-IFN-α|90 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219689|NCT02328755|OG001|Outcome|Dose Level 2 - 180 mg Peg-IFN-α|180 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219690|NCT02328755|OG000|Outcome|Dose Level 1 - 90 mcg Peg-IFN-α|90 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219691|NCT02328755|OG001|Outcome|Dose Level 2 - 180 mcg Peg-IFN-α|180 mcg peg-IFN-α administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days.
11219692|NCT02328755|OG000|Outcome|Peg-IFN-α|"peg-IFN-α was administered prior to HCT (Hematopoietic Cell Transplant) and at three subsequent time points post HCT. (Maximum of 4 doses) It was administered by subcutaneous injection every 14 days beginning with dose level 1.~Dose Level 1 - 90 mcg Dose Level 2 - 180 mcg peg-IFN-α"
11219693|NCT02328755|OG000|Outcome|180mcg Peg-IFN-α, HLA-matched|180 mcg peg-IFN-a administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days
11219694|NCT02328755|OG000|Outcome|189mcg Peg-IFN-α, HLA-matched|180 mcg peg-IFN-a administered prior to hematopoietic cell transplantation (HCT) and at three subsequent time points post HCT (maximum of 4 doses) every 14 days
11219695|NCT02328755|EG000|Reported Event|Phase I/Dose Level 1 - 90 mcg|peg-IFN-α 90 mcg administered prior to hematopoietic cell transplant (HCT) and at three subsequent time points post HCT (maximum of 4 doses), every 14 days. Tacrolimus: Calcineurin inhibitor administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis. Cyclosporine could be substituted if patients cannot tolerate tacrolimus. Methotrexate: Administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis.
11219696|NCT02328755|EG001|Reported Event|Phase 2/Dose Level 2 - 180 mcg Peg-IFN-α|peg-IFN-α 180 mcg administered prior to hematopoietic cell transplant (HCT) and at three subsequent time points post HCT (maximum of 4 doses), every 14 days. Tacrolimus: Calcineurin inhibitor administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis. Cyclosporine could be substituted if patients cannot tolerate tacrolimus. Methotrexate: Administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis.
11219697|NCT02328807|BG000|Baseline|Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra|Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
11219698|NCT02328807|FG000|Participant Flow|Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra|Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
11219699|NCT02328807|OG000|Outcome|Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra|Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
11219700|NCT02328807|OG000|Outcome|Quality of Life Assessments - Prior to RFA|Quality of Life Assessments prior to focal Prostate Radio-Frequency Ablation (RFA).
11219701|NCT02328807|OG001|Outcome|Quality of Life Assessments - After RFA|Quality of Life Assessments after focal Prostate Radio-Frequency Ablation (RFA)
11219702|NCT02328807|EG000|Reported Event|Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra|Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
11219703|NCT02328937|BG000|Baseline|Overall|All subjects that were dispensed at least one study lens.
11219704|NCT02328937|FG000|Participant Flow|Etafilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.
11219705|NCT02328937|FG001|Participant Flow|Etafilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.
11219706|NCT02328937|FG002|Participant Flow|Lotrafilcon B/Etafilcon A/Comfilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.
11219707|NCT02328937|FG003|Participant Flow|Lotrafilcon B/Comfilcon A/Etafilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.
11219708|NCT02328937|FG004|Participant Flow|Comfilcon A/Etafilcon A/Lotrafilcon B|Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.
11219709|NCT02328937|FG005|Participant Flow|Comfilcon A/Lotrafilcon B/Etafilcon A|Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
11219710|NCT02328937|OG000|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
11219711|NCT02328937|OG001|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
11219712|NCT02328937|OG002|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
11219713|NCT02328937|EG000|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
11219714|NCT02328937|EG001|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
11219715|NCT02328937|EG002|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
11219716|NCT02329015|BG000|Baseline|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
11219717|NCT02329015|BG001|Baseline|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
11219718|NCT02329015|BG002|Baseline|Total|Total of all reporting groups
11219719|NCT02329015|FG000|Participant Flow|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
11219720|NCT02329015|FG001|Participant Flow|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
11219721|NCT02329015|OG000|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
11219722|NCT02329015|OG001|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
11219723|NCT02329015|EG000|Reported Event|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
11219724|NCT02329015|EG001|Reported Event|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
11219725|NCT02329223|BG000|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219726|NCT02329223|BG001|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219727|NCT02329223|BG002|Baseline|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
11219728|NCT02329223|BG003|Baseline|Total|Total of all reporting groups
11219729|NCT02329223|FG000|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219730|NCT02329223|FG001|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219731|NCT02329223|FG002|Participant Flow|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
11219732|NCT02329223|OG000|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219733|NCT02329223|OG001|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
11219734|NCT02329223|OG002|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
11219735|NCT02329223|EG000|Reported Event|IGE025 300 mg|IGE025 300 mg
11219736|NCT02329223|EG001|Reported Event|IGE025 150 mg|IGE025 150 mg
11219737|NCT02329223|EG002|Reported Event|Placebo|Placebo
11219738|NCT02329431|BG000|Baseline|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
11219739|NCT02329431|BG001|Baseline|Support Group|"Parent-directed support group~support group: parent directed support group"
11219740|NCT02329431|BG002|Baseline|Total|Total of all reporting groups
11219741|NCT02329431|FG000|Participant Flow|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
11219742|NCT02329431|FG001|Participant Flow|Support Group|"Parent-directed support group~support group: parent directed support group"
11219743|NCT02329431|OG000|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
11219744|NCT02329431|OG001|Outcome|Support Group|"Parent-directed support group~support group: parent directed support group"
11219745|NCT02329431|EG000|Reported Event|Activation Curriculum|"Psycho-social curriculum teaching activation skills~activation curriculum: psychosocial activation curriculum"
11219746|NCT02329431|EG001|Reported Event|Support Group|"Parent-directed support group~support group: parent directed support group"
11328479|NCT03428230|FG001|Participant Flow|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)~60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328480|NCT03428230|FG002|Participant Flow|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT)~90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328481|NCT03428230|FG003|Participant Flow|Placebo, 0.9% Saline Solution|"Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT)~Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328482|NCT03428230|OG000|Outcome|30 mg Paracetamol 3% (1 mL)|"30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT)~30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328483|NCT03428230|OG001|Outcome|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)~60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11333828|NCT03520387|FG001|Participant Flow|Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
10834689|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)
11328484|NCT03428230|OG002|Outcome|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT)~90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328485|NCT03428230|OG003|Outcome|Placebo, 0.9% Saline Solution|"Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT)~Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328486|NCT03428230|EG000|Reported Event|30 mg Paracetamol 3% (1 mL)|"30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT)~30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328487|NCT03428230|EG001|Reported Event|60 mg Paracetamol 3% (2 mL)|"60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)~60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328488|NCT03428230|EG002|Reported Event|90 mg Paracetamol 3% (3 mL)|"90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT)~90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11333829|NCT03520387|FG002|Participant Flow|Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
10834690|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
11328489|NCT03428230|EG003|Reported Event|Placebo, 0.9% Saline Solution|"Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT)~Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia.~The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.~NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min."
11328490|NCT03428360|BG000|Baseline|Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug|"Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.~Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff."
11328491|NCT03428360|FG000|Participant Flow|Safety Set|"Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.~Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff."
11328492|NCT03428360|OG000|Outcome|Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug|"Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.~Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff."
11328493|NCT03428360|OG000|Outcome|Subjects With Epilepsy|"Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.~Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff."
11328494|NCT03428360|OG000|Outcome|Total Use Occasions|Analysis is based upon the total number times the study drug was used over the course of the study - subjects could have multiple use occasions during the study: Total number of use occasions reported was 1348 for the total 130 subjects in the Safety Population
11328495|NCT03428360|OG000|Outcome|Study Drug Use Occasions|Total number of use occasions reported over the course of the study; each subject could report multiple use occasions during the study
11328496|NCT03428360|OG000|Outcome|Study Drug Use Occasions|Total number of use occasions reported during the study; each subject could report multiple use occasions over the course of the study
11328497|NCT03428360|EG000|Reported Event|Safety Analysis Set|"Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.~Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff."
11328498|NCT03428750|BG000|Baseline|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11328499|NCT03428750|BG001|Baseline|Placebo|Placebo-control
11328500|NCT03428750|BG002|Baseline|Total|Total of all reporting groups
11328501|NCT03428750|FG000|Participant Flow|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11328502|NCT03428750|FG001|Participant Flow|Placebo|Placebo-control
11328503|NCT03428750|OG000|Outcome|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock
11328504|NCT03428750|OG001|Outcome|Placebo|Placebo-control
11328505|NCT03428750|OG000|Outcome|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock (1.68 mg Total Dose)
11328506|NCT03428750|OG000|Outcome|Day 1: CCH|Baseline (Day 1) for CCH Treated Group
11328507|NCT03428750|OG001|Outcome|Day 1: Placebo|Baseline (Day 1) for Placebo Group
11328508|NCT03428750|OG002|Outcome|Day 22: CCH|Day 22 for CCH Treated Group
11328509|NCT03428750|OG003|Outcome|Day 22: Placebo|Day 22 for Placebo Group
11328510|NCT03428750|OG004|Outcome|Day 43: CCH|Day 43 for CCH Treated Group
11328511|NCT03428750|OG005|Outcome|Day 43: Placebo|Day 43 for Placebo Group
11328512|NCT03428750|OG006|Outcome|Day 71: CCH|Day 71 for CCH Treated Group
11328513|NCT03428750|OG007|Outcome|Day 71: Placebo|Day 71 for Placebo Group
11328514|NCT03428750|OG008|Outcome|Day 71: CCH (LOCF)|Day 71 for CCH Treated Group (Last observation carried forward)
11328515|NCT03428750|OG009|Outcome|Day 71: Placebo (LOCF)|Day 71 for Placebo Group (Last observation carried forward)
11328516|NCT03428750|OG000|Outcome|Day 71: CCH|CCH
11328517|NCT03428750|OG001|Outcome|Day 71: Placebo|Placebo
11328518|NCT03428750|OG002|Outcome|Day 71: CCH (LOCF)|Last Observation Carried Forward - CCH
11328519|NCT03428750|OG003|Outcome|Day 71: Placebo (LOCF)|Last Observation Carried Forward - Placebo
11328520|NCT03428750|OG000|Outcome|Anti-AUX-I: CCH|CCH
11328521|NCT03428750|OG001|Outcome|Anti-AUX-I: Placebo|Placebo
11328522|NCT03428750|OG002|Outcome|Anti-AUX-II: CCH|CCH
11328523|NCT03428750|OG003|Outcome|Anti-AUX-II: Placebo|Placebo
11328524|NCT03428750|OG000|Outcome|Anit-AUX-I: CCH|CCH
11328525|NCT03428750|OG000|Outcome|CCH: Q1|Quartile 1
11328526|NCT03428750|OG001|Outcome|CCH: Q4|Quartile 4
11328527|NCT03428750|OG002|Outcome|CCH: Total|Total
11328528|NCT03428750|EG000|Reported Event|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11328529|NCT03428750|EG001|Reported Event|Placebo|Placebo-control
11328530|NCT03428815|BG000|Baseline|PCM Liner|"Willowwood Smart Temp Liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328531|NCT03428815|BG001|Baseline|Regular Liner|"User's regular prescribed liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328532|NCT03428815|BG002|Baseline|Total|Total of all reporting groups
11328533|NCT03428815|FG000|Participant Flow|First PCM Liner, Then Regular Liner|Prosthesis suspension liner: Liners out of phase change material (Willowwood Smart Temp Liner) are fitted first. After 6 months they are exchanged against a set of regular liners
11328534|NCT03428815|FG001|Participant Flow|First Regular Liner, Then PCM Liner|Prosthesis suspension liner: Participants' regular liners are fitted first. After 6 months they are exchanged against a set of phase change material liners (Willowwood Smart Temp Liner)
11328535|NCT03428815|OG000|Outcome|PCM Liner|"Willowwood Smart Temp Liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328536|NCT03428815|OG001|Outcome|Regular Liner|"User's regular prescribed liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328537|NCT03428815|EG000|Reported Event|PCM Liner|"Willowwood Smart Temp Liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328538|NCT03428815|EG001|Reported Event|Regular Liner|"User's regular prescribed liner~Prosthesis suspension liner: Liners out of phase change material will be fitted"
11328539|NCT03428997|BG000|Baseline|Lotion and Negative Control|The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
11328540|NCT03428997|FG000|Participant Flow|Lotion and Negative Control|The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
11328541|NCT03428997|OG000|Outcome|Lotion|The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks.
11328542|NCT03428997|OG001|Outcome|Negative Control|Undosed occlusive patch (negative control) was applied to a test site on each subject's back three times a week for four weeks.
11328543|NCT03428997|EG000|Reported Event|Lotion|The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks.
11328544|NCT03428997|EG001|Reported Event|Negative Control|The undosed occlusive patch (negative control) was applied to a test site on each subjects back three times a week for four weeks.
11328545|NCT03429270|BG000|Baseline|Urodynamics Arm|TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
11328546|NCT03429270|FG000|Participant Flow|Urodynamics Arm|Urodynamic testing and data collection(per protocol) using the TDOC 5Fr catheters.
11328547|NCT03429270|OG000|Outcome|Urodynamics Arm|TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
11328548|NCT03429270|EG000|Reported Event|Urodynamics Arm|TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
11328549|NCT03429348|BG000|Baseline|No Additional Rehabilitation|No additional rehabilitation will be done
10834691|NCT00166166|OG001|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
10834692|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin
10834693|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)
10834694|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole
11328550|NCT03429348|BG001|Baseline|Sauna Rehabilitation|"An additional rehabilitation in a sauna will be done~Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna"
11328551|NCT03429348|BG002|Baseline|Total|Total of all reporting groups
10834695|NCT00166166|OG000|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)
10843311|NCT00253643|BG002|Baseline|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
11328552|NCT03429348|FG000|Participant Flow|No Additional Rehabilitation|No additional rehabilitation will be done
11328553|NCT03429348|FG001|Participant Flow|Sauna Rehabilitation|"An additional rehabilitation in a sauna will be done~Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna"
10834696|NCT00166166|EG000|Reported Event|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834697|NCT00166166|EG001|Reported Event|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
10834698|NCT00166205|BG000|Baseline|Swedish Adjustable Gastric Band (SAGB)|
10834699|NCT00166205|FG000|Participant Flow|Swedish Adjustable Gastric Band (SAGB)|
10834700|NCT00166205|OG000|Outcome|Swedish Adjustable Gastric Band (SAGB)|
10834701|NCT00166205|EG000|Reported Event|Swedish Adjustable Gastric Band (SAGB)|
10834702|NCT00166296|BG000|Baseline|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
11219747|NCT02329587|BG000|Baseline|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
10834703|NCT00166296|BG001|Baseline|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834704|NCT00166296|BG002|Baseline|Total|Total of all reporting groups
10834705|NCT00166296|FG000|Participant Flow|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834706|NCT00166296|FG001|Participant Flow|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834707|NCT00166296|OG000|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834708|NCT00166296|OG001|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834709|NCT00166296|EG000|Reported Event|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834710|NCT00166296|EG001|Reported Event|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
10834711|NCT00166361|BG000|Baseline|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
10834712|NCT00166361|BG001|Baseline|JJ Stent|Subjects assigned to this arm received a JJ stent.
10834713|NCT00166361|BG002|Baseline|Total|Total of all reporting groups
10834714|NCT00166361|FG000|Participant Flow|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
10834715|NCT00166361|FG001|Participant Flow|JJ Stent|Subjects assigned to this arm received a JJ stent.
10834716|NCT00166361|OG000|Outcome|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
10834717|NCT00166361|OG001|Outcome|JJ Stent|Subjects assigned to this arm received a JJ stent.
10834718|NCT00166361|EG000|Reported Event|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
10834719|NCT00166361|EG001|Reported Event|JJ Stent|Subjects assigned to this arm received a JJ stent.
10834720|NCT00166439|BG000|Baseline|Treatment (ROAD)|The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m^2 IV over 2 hours on day 2; cytarabine 2000 mg/m^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
10834721|NCT00166439|FG000|Participant Flow|Treatment (ROAD)|The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m^2 IV over 2 hours on day 2; cytarabine 2000 mg/m^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
10834722|NCT00166439|OG000|Outcome|Treatment (ROAD)|The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m^2 IV over 2 hours on day 2; cytarabine 2000 mg/m^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
10834723|NCT00166439|EG000|Reported Event|Treatment (ROAD)|The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m^2 IV over 2 hours on day 2; cytarabine 2000 mg/m^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
10834724|NCT00166517|BG000|Baseline|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834725|NCT00166517|BG001|Baseline|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834726|NCT00166517|BG002|Baseline|Total|Total of all reporting groups
10834727|NCT00166517|FG000|Participant Flow|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834728|NCT00166517|FG001|Participant Flow|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834729|NCT00166517|OG000|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834730|NCT00166517|OG001|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834731|NCT00166517|EG000|Reported Event|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834732|NCT00166517|EG001|Reported Event|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
10834733|NCT00166712|BG000|Baseline|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC (Prograf) started on the 1st day after surgery, and then taken by mouth twice daily.
10834734|NCT00166712|BG001|Baseline|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
10834735|NCT00166712|BG002|Baseline|Total|Total of all reporting groups
11219748|NCT02329587|BG001|Baseline|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
10834736|NCT00166712|FG000|Participant Flow|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
10834737|NCT00166712|FG001|Participant Flow|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
10834738|NCT00166712|OG000|Outcome|Groups|Evaluated for rejection of their transplanted kidney with a biopsy.
10834739|NCT00166712|OG001|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
10834740|NCT00166712|OG000|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
10834741|NCT00166712|OG001|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
10834742|NCT00166712|OG000|Outcome|Group 1|Evaluated for rejection of their transplanted kidney with a biopsy.
10834743|NCT00166712|EG000|Reported Event|Group 1: Alemtuzumab + TAC + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
10834744|NCT00166712|EG001|Reported Event|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
10834745|NCT00166712|EG002|Reported Event|Group 1: Post-conversion to Sirolimus|After conversion to Sirolimus, if no rejection of transplanted kidney within 9 months post-transplant, will be weaned off Sirolimus.
10834746|NCT00167102|BG000|Baseline|Alefacept|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834747|NCT00167102|BG001|Baseline|Placebo|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834748|NCT00167102|BG002|Baseline|Total|Total of all reporting groups
10834749|NCT00167102|FG000|Participant Flow|Alefacept|Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period.
10834750|NCT00167102|FG001|Participant Flow|Placebo|Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.
10834751|NCT00167102|OG000|Outcome|Alefacept|Weekly intramuscular administration of alefacept 15mg for 12 weeks
10834752|NCT00167102|OG001|Outcome|Placebo|Weekly intramuscular administration of placebo 15 mg for 12 weeks
10834753|NCT00167102|OG000|Outcome|Alefacept|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834754|NCT00167102|OG001|Outcome|Placebo|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834755|NCT00167102|EG000|Reported Event|Alefacept|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834756|NCT00167102|EG001|Reported Event|Placebo|Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
10834757|NCT00167180|BG000|Baseline|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10^8 CD3+ T-cells/kg
10834758|NCT00167180|BG001|Baseline|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10^8 CD3+ T-cells/kg
10834759|NCT00167180|BG002|Baseline|Total|Total of all reporting groups
10834760|NCT00167180|FG000|Participant Flow|Chronic Myelogenous Leukemia (CML)|"Patients who have failed or refused Gleevec (TM) therapy and will receive Donor Lymphocyte Infusion.~Donor Lymphocyte Infusion: donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg"
10834761|NCT00167180|FG001|Participant Flow|Non-CML or CML Failing Donor Lymphocyte Infusion|"Patients with non-CML or CML who have failed DLI and will receive Induction Chemotherapy + DLI.~Induction Chemotherapy + DLI: Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV Donor Lymphocyte Infusion (DLI)"
10834762|NCT00167180|OG000|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10^8 CD3+ T-cells/kg
10834763|NCT00167180|OG001|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10^8 CD3+ T-cells/kg
10834764|NCT00167180|EG000|Reported Event|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10^8 CD3+ T-cells/kg
10834765|NCT00167180|EG001|Reported Event|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10^8 CD3+ T-cells/kg
10834766|NCT00167206|BG000|Baseline|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
10834767|NCT00167206|FG000|Participant Flow|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
10834768|NCT00167206|OG000|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
10834769|NCT00167206|EG000|Reported Event|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
10834770|NCT00167245|BG000|Baseline|Group 1|"topiramate~Topiramate : 300mg/day for 13 weeks"
10834771|NCT00167245|BG001|Baseline|Group 2|placebo : placebo pills
10834772|NCT00167245|BG002|Baseline|Total|Total of all reporting groups
10834773|NCT00167245|FG000|Participant Flow|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
10834774|NCT00167245|FG001|Participant Flow|Placebo|placebo : placebo pills
10834775|NCT00167245|OG000|Outcome|Topirmate|"topiramate~Topiramate : 300mg/day for 13 weeks"
10834776|NCT00167245|OG001|Outcome|Placebo|placebo : placebo pills
10834777|NCT00167245|OG000|Outcome|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
10834778|NCT00167245|OG000|Outcome|Group 1|"topiramate~Topiramate: 300mg/day for 13 weeks"
10834779|NCT00167245|OG001|Outcome|Group 2|placebo: placebo pills
10834780|NCT00167245|EG000|Reported Event|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
10834781|NCT00167245|EG001|Reported Event|Placebo|placebo : placebo pills
10834782|NCT00167310|BG000|Baseline|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
11219749|NCT02329587|BG002|Baseline|Total|Total of all reporting groups
10834783|NCT00167310|BG001|Baseline|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834784|NCT00167310|BG002|Baseline|Total|Total of all reporting groups
10834785|NCT00167310|FG000|Participant Flow|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834786|NCT00167310|FG001|Participant Flow|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834787|NCT00167310|OG000|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834788|NCT00167310|OG001|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834789|NCT00167310|EG000|Reported Event|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834790|NCT00167310|EG001|Reported Event|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
10834791|NCT00167388|BG000|Baseline|Group 1|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight <1250 at time of study and randomized to feeding during the PRBC transfusion"
10834792|NCT00167388|BG001|Baseline|Group 2|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight <1250 at time of study and randomized to not feeding during the PRBC transfusion"
10834793|NCT00167388|BG002|Baseline|Group 3|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight >1250 at time of study and randomized to feeding during the PRBC transfusion"
10834794|NCT00167388|BG003|Baseline|Group 4|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight >1250 at time of study and randomized to not feeding during the PRBC transfusion"
10834795|NCT00167388|BG004|Baseline|Total|Total of all reporting groups
10834796|NCT00167388|FG000|Participant Flow|Group 1|<1250 gm at time of study, Fed during PRBC transfusion
10834797|NCT00167388|FG001|Participant Flow|Group 2|<1250 gm at time of study, Not fed during PRBC transfusion
10834798|NCT00167388|FG002|Participant Flow|Group 3|>1250 gm at time of study, Fed during PRBC transfusion
10834799|NCT00167388|FG003|Participant Flow|Group 4|>1250 gm at time of study, Not fed during PRBC transfusion
10834800|NCT00167388|OG000|Outcome|Groups 1 and 2|Infants <1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
10834801|NCT00167388|OG001|Outcome|Groups 3 and 4|Infants >1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
10834802|NCT00167388|EG000|Reported Event|Group 1|< 1250 gm Fed during the study
10834803|NCT00167388|EG001|Reported Event|Group 2|<1250 gm, not fed during the study
10834804|NCT00167388|EG002|Reported Event|Group 3|>1250 gm, fed during the study
10834805|NCT00167388|EG003|Reported Event|Group 4|>1250 gm, not fed during the study
10834806|NCT00167414|BG000|Baseline|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
10834807|NCT00167414|FG000|Participant Flow|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
10834808|NCT00167414|OG000|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
10834809|NCT00167414|EG000|Reported Event|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
10834810|NCT00167544|BG000|Baseline|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
10834811|NCT00167544|BG001|Baseline|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
10834812|NCT00167544|BG002|Baseline|Total|Total of all reporting groups
10834813|NCT00167544|FG000|Participant Flow|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
10834814|NCT00167544|FG001|Participant Flow|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
10834815|NCT00167544|OG000|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
10834816|NCT00167544|OG001|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
10834817|NCT00167544|EG000|Reported Event|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
10834818|NCT00167544|EG001|Reported Event|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
10834819|NCT00167661|BG000|Baseline|Campath 1-H|Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
10834820|NCT00167661|FG000|Participant Flow|Campath 1-H|Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
10834821|NCT00167661|OG000|Outcome|Campath 1-H|Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
10834822|NCT00167661|EG000|Reported Event|Campath 1-H|Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
10834823|NCT00167778|BG000|Baseline|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
10834824|NCT00167778|FG000|Participant Flow|Amputee|This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
10834825|NCT00167778|OG000|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
10834826|NCT00167778|OG001|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
10834827|NCT00167778|EG000|Reported Event|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
10834828|NCT00167934|BG000|Baseline|Placebo|50% of participants will receive placebo
10834829|NCT00167934|BG001|Baseline|Experimental|50% of participants will receive Depakote ER
10834830|NCT00167934|BG002|Baseline|Total|Total of all reporting groups
10834831|NCT00167934|FG000|Participant Flow|Placebo|50% of participants will receive placebo
10834832|NCT00167934|FG001|Participant Flow|Experimental|50% of participants will receive Depakote ER
10834833|NCT00167934|OG000|Outcome|Placebo|50% of participants will receive placebo
10834834|NCT00167934|OG001|Outcome|Experimental|50% of participants will receive Depakote ER
10834835|NCT00167934|EG000|Reported Event|Placebo|50% of participants will receive placebo
10834836|NCT00167934|EG001|Reported Event|Experimental|50% of participants will receive Depakote ER
10834837|NCT00168038|BG000|Baseline|IgPro10|All subjects treated with IgPro10
10834838|NCT00168038|FG000|Participant Flow|IgPro10|All subjects treated with IgPro10
10834839|NCT00168038|OG000|Outcome|IgPro10|All subjects treated with IgPro10
11219750|NCT02329587|FG000|Participant Flow|ERP Plus tDCS|"Exposure and response prevention (ERP) plus anodal transcranial direct current stimulation (tDCS) of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
11219751|NCT02329587|FG001|Participant Flow|ERP Plus Sham tDCS|"Exposure and response prevention (ERP) plus sham transcranial direct current stimulation (tDCS) of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
10834840|NCT00168038|EG000|Reported Event|IgPro10|All subjects treated with IgPro10
10834841|NCT00168064|BG000|Baseline|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
10834842|NCT00168064|BG001|Baseline|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
10834843|NCT00168064|BG002|Baseline|Total|Total of all reporting groups
10834844|NCT00168064|FG000|Participant Flow|PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel|Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
10834845|NCT00168064|FG001|Participant Flow|AP- Mechlorethamine 0.02% Compounded in Aquaphor|Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
10834846|NCT00168064|OG000|Outcome|PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
10834847|NCT00168064|OG001|Outcome|AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%|Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%
10834848|NCT00168064|OG000|Outcome|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
10834849|NCT00168064|OG001|Outcome|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
10834850|NCT00168064|EG000|Reported Event|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
10834851|NCT00168064|EG001|Reported Event|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
10834852|NCT00168103|BG000|Baseline|C1-INH 10 U/kg bw|Baseline characteristics were calculated only for the intention to treat (ITT) and per protocol (PP) analysis populations, not for all enrolled subjects. Baseline data presented here are for subjects included in the ITT population. One (1) subject enrolled and randomized to the C1-INH 10 U/kg bw group was excluded from the ITT analysis population.
10834853|NCT00168103|BG001|Baseline|C1-INH 20 U/kg bw|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the C1-INH 20 U/kg bw arm were included in the ITT analysis population.
10834854|NCT00168103|BG002|Baseline|Placebo|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the Placebo arm were included in the ITT analysis population.
10834855|NCT00168103|BG003|Baseline|Total|Total of all reporting groups
10834856|NCT00168103|FG000|Participant Flow|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1 Esterase Inhibitor (C1-INH) 10 Units (U)/kg body weight (bw) arm.
10834857|NCT00168103|FG001|Participant Flow|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
10834858|NCT00168103|FG002|Participant Flow|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
10834859|NCT00168103|FG003|Participant Flow|Not Randomized|Includes one subject enrolled who was not randomized but received treatment with 20 U/kg bw C1-INH.
10834860|NCT00168103|OG000|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
10834861|NCT00168103|OG001|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
10834862|NCT00168103|OG002|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
10834863|NCT00168103|EG000|Reported Event|C1-INH 10 U/kg bw|Includes subjects receiving 10 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment.
10834864|NCT00168103|EG001|Reported Event|C1-INH 20 U/kg bw|Includes subjects receiving 20 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment (n=43). An additional 3 subjects not randomized to but treated with 20 U/kg bw C1-INH in this time period were also included in this group for the safety analysis.
10834865|NCT00168103|EG002|Reported Event|Placebo|Includes subjects receiving Placebo and no rescue study medication within 4 hours after the start of the initial treatment.
10834866|NCT00168298|BG000|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
10834867|NCT00168298|BG001|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834868|NCT00168298|BG002|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834869|NCT00168298|BG003|Baseline|Total|Total of all reporting groups
10834870|NCT00168298|FG000|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
10834871|NCT00168298|FG001|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834872|NCT00168298|FG002|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834873|NCT00168298|OG000|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
10834874|NCT00168298|OG001|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
10834875|NCT00168298|OG002|Outcome|Sham Injection|Sham injection on Day 0.
10834876|NCT00168298|EG000|Reported Event|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
10834877|NCT00168298|EG001|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
10834878|NCT00168298|EG002|Reported Event|Sham Injection|Sham injection on Day 0.
10834879|NCT00168311|BG000|Baseline|Active Treatment|Bilateral high frequency (10Hz) rTMS
10834880|NCT00168311|BG001|Baseline|Sham Treatment|Sham bilateral rTMS treatment
10834881|NCT00168311|BG002|Baseline|Total|Total of all reporting groups
10834882|NCT00168311|FG000|Participant Flow|Active Treatment|Bilateral high frequency (10Hz) rTMS
10834883|NCT00168311|FG001|Participant Flow|Sham Treatment|Sham bilateral rTMS treatment
10834884|NCT00168311|OG000|Outcome|Active Treatment|Bilateral high frequency (10Hz) rTMS
10834885|NCT00168311|OG001|Outcome|Sham Treatment|Sham bilateral rTMS treatment
10834886|NCT00168311|EG000|Reported Event|Active Treatment|Bilateral high frequency (10Hz) rTMS
10834887|NCT00168311|EG001|Reported Event|Sham Treatment|Sham bilateral rTMS treatment
10834888|NCT00168324|BG000|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
10834889|NCT00168324|BG001|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834890|NCT00168324|BG002|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834891|NCT00168324|BG003|Baseline|Total|Total of all reporting groups
10834892|NCT00168324|FG000|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
10834893|NCT00168324|FG001|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834894|NCT00168324|FG002|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
10834895|NCT00168324|OG000|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
10834896|NCT00168324|OG001|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
10834897|NCT00168324|OG002|Outcome|Sham Injection|Sham injection on Day 0.
10834898|NCT00168324|EG000|Reported Event|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
10834899|NCT00168324|EG001|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
10834900|NCT00168324|EG002|Reported Event|Sham Injection|Sham injection on Day 0.
10834901|NCT00168337|BG000|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834902|NCT00168337|BG001|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834903|NCT00168337|BG002|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834904|NCT00168337|BG003|Baseline|Total|Total of all reporting groups
10834905|NCT00168337|FG000|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834906|NCT00168337|FG001|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834907|NCT00168337|FG002|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834908|NCT00168337|OG000|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834909|NCT00168337|OG001|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834910|NCT00168337|OG002|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834911|NCT00168337|EG000|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834912|NCT00168337|EG001|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834913|NCT00168337|EG002|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834914|NCT00168389|BG000|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834915|NCT00168389|BG001|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834916|NCT00168389|BG002|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834917|NCT00168389|BG003|Baseline|Total|Total of all reporting groups
10834918|NCT00168389|FG000|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834919|NCT00168389|FG001|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834920|NCT00168389|FG002|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834921|NCT00168389|OG000|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834922|NCT00168389|OG001|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834923|NCT00168389|OG002|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834924|NCT00168389|EG000|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834925|NCT00168389|EG001|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
10834926|NCT00168389|EG002|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
10834927|NCT00168428|BG000|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10834928|NCT00168428|BG001|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10834929|NCT00168428|BG002|Baseline|Total|Total of all reporting groups
10834930|NCT00168428|FG000|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10834931|NCT00168428|FG001|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10834932|NCT00168428|OG000|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10834933|NCT00168428|OG001|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10834934|NCT00168428|EG000|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
10834935|NCT00168428|EG001|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
10834936|NCT00168454|BG000|Baseline|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
10834937|NCT00168454|BG001|Baseline|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
10834938|NCT00168454|BG002|Baseline|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
10834939|NCT00168454|BG003|Baseline|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
10834940|NCT00168454|BG004|Baseline|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
10834941|NCT00168454|BG005|Baseline|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
10834942|NCT00168454|BG006|Baseline|Total|Total of all reporting groups
10834943|NCT00168454|FG000|Participant Flow|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
10834944|NCT00168454|FG001|Participant Flow|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
10834945|NCT00168454|FG002|Participant Flow|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
10834946|NCT00168454|FG003|Participant Flow|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
10834947|NCT00168454|FG004|Participant Flow|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
10834948|NCT00168454|FG005|Participant Flow|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
10834949|NCT00168454|OG000|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
10834950|NCT00168454|OG001|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
10834951|NCT00168454|OG002|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
10834952|NCT00168454|OG003|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
10834953|NCT00168454|OG004|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
10834954|NCT00168454|OG005|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
10834955|NCT00168454|EG000|Reported Event|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
10834956|NCT00168454|EG001|Reported Event|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
10834957|NCT00168454|EG002|Reported Event|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
10834958|NCT00168454|EG003|Reported Event|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
10834959|NCT00168454|EG004|Reported Event|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
10834960|NCT00168454|EG005|Reported Event|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
10834961|NCT00168805|BG000|Baseline|Dabigatran 220mg|qd (once daily) oral
10834962|NCT00168805|BG001|Baseline|Dabigatran 150mg|qd (once daily) oral
10834963|NCT00168805|BG002|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
10834964|NCT00168805|BG003|Baseline|Total|Total of all reporting groups
10834965|NCT00168805|FG000|Participant Flow|Dabigatran 220mg|qd (once daily) oral
10834966|NCT00168805|FG001|Participant Flow|Dabigatran 150mg|qd (once daily) oral
10834967|NCT00168805|FG002|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
10834968|NCT00168805|OG000|Outcome|Dabigatran 220mg|qd (once daily) oral
10834969|NCT00168805|OG001|Outcome|Dabigatran 150mg|qd (once daily) oral
10834970|NCT00168805|OG002|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
10834971|NCT00168805|EG000|Reported Event|Dabigatran 220mg|qd (once daily) oral
10834972|NCT00168805|EG001|Reported Event|Dabigatran 150mg|qd (once daily) oral
10834973|NCT00168805|EG002|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
10834974|NCT00168818|BG000|Baseline|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834975|NCT00168818|BG001|Baseline|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834976|NCT00168818|BG002|Baseline|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
10834977|NCT00168818|BG003|Baseline|Total|Total of all reporting groups
10834978|NCT00168818|FG000|Participant Flow|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834979|NCT00168818|FG001|Participant Flow|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834980|NCT00168818|FG002|Participant Flow|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
10834981|NCT00168818|OG000|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834982|NCT00168818|OG001|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834983|NCT00168818|OG002|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
10834984|NCT00168818|EG000|Reported Event|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834985|NCT00168818|EG001|Reported Event|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
10834986|NCT00168818|EG002|Reported Event|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
10834987|NCT00168831|BG000|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10834988|NCT00168831|BG001|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10834989|NCT00168831|BG002|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10834990|NCT00168831|BG003|Baseline|Total|Total of all reporting groups
10834991|NCT00168831|FG000|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10834992|NCT00168831|FG001|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10834993|NCT00168831|FG002|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10834994|NCT00168831|OG000|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10834995|NCT00168831|OG001|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10834996|NCT00168831|OG002|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10834997|NCT00168831|EG000|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10834998|NCT00168831|EG001|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10834999|NCT00168831|EG002|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
11219752|NCT02329587|OG000|Outcome|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
10835000|NCT00168844|BG000|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10835001|NCT00168844|BG001|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10835002|NCT00168844|BG002|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10835003|NCT00168844|BG003|Baseline|Total|Total of all reporting groups
10835004|NCT00168844|FG000|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10835005|NCT00168844|FG001|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10835006|NCT00168844|FG002|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10835007|NCT00168844|OG000|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10835008|NCT00168844|OG001|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10835009|NCT00168844|OG002|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10835010|NCT00168844|EG000|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
10835011|NCT00168844|EG001|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
10835012|NCT00168844|EG002|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
10835013|NCT00169104|BG000|Baseline|G-CSF Arm|Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14.
10842855|NCT00249834|FG007|Participant Flow|Gonal-f 300 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10835014|NCT00169104|BG001|Baseline|Placebo Arm|Subjects will receive ten doses of a placebo injection SQ daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14.
10835015|NCT00169104|BG002|Baseline|Total|Total of all reporting groups
10835016|NCT00169104|FG000|Participant Flow|G-CSF Arm|Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14.
10835017|NCT00169104|FG001|Participant Flow|Placebo Arm|Subjects will receive ten doses of a placebo injection SQ daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14.
10835018|NCT00169104|OG000|Outcome|G-CSF Arm|"Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14.~G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14~trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14~vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13~G-CSF: 5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study"
10835019|NCT00169104|OG001|Outcome|Placebo Arm|"Subjects will receive ten doses of a placebo injection SQ daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14.~G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14~trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14~vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13~saline placebo: Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study"
10835020|NCT00169104|OG000|Outcome|All Patients|
10835021|NCT00169104|EG000|Reported Event|G-CSF|"Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14.~G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14~trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14~vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13~G-CSF: 5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study"
10835022|NCT00169104|EG001|Reported Event|{Placebo|"Subjects will receive ten doses of a placebo injection SQ daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14.~G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14~trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14~vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13~saline placebo: Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study"
10835023|NCT00169442|BG000|Baseline|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835024|NCT00169442|BG001|Baseline|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835025|NCT00169442|BG002|Baseline|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835026|NCT00169442|BG003|Baseline|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
11219753|NCT02329587|OG001|Outcome|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
11219754|NCT02329587|EG000|Reported Event|ERP Plus tDCS|"ERP plus anodal tDCS of right inferior frontal gyrus~ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
11219755|NCT02329587|EG001|Reported Event|ERP Plus Sham tDCS|"ERP plus sham tDCS of right inferior frontal gyrus~ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise."
10835027|NCT00169442|BG004|Baseline|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835028|NCT00169442|BG005|Baseline|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835029|NCT00169442|BG006|Baseline|Total|Total of all reporting groups
10835030|NCT00169442|FG000|Participant Flow|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835031|NCT00169442|FG001|Participant Flow|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835032|NCT00169442|FG002|Participant Flow|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835033|NCT00169442|FG003|Participant Flow|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
10835034|NCT00169442|FG004|Participant Flow|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835035|NCT00169442|FG005|Participant Flow|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835036|NCT00169442|OG000|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835037|NCT00169442|OG001|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835038|NCT00169442|OG000|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835039|NCT00169442|OG001|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835040|NCT00169442|OG002|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
10835041|NCT00169442|OG003|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
10835042|NCT00169442|OG000|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
10835043|NCT00169442|OG001|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
10835044|NCT00169442|OG002|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
10835045|NCT00169442|EG000|Reported Event|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
10835046|NCT00169442|EG001|Reported Event|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
10835047|NCT00169442|EG002|Reported Event|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
10835048|NCT00169442|EG003|Reported Event|PRP TRITANRIX-HEPB KFT. MIX GROUP|Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
11219756|NCT02329600|BG000|Baseline|Control Subjects|10 systemically healthy control subjects taking no medication.
10835049|NCT00169442|EG004|Reported Event|PRP TRITANRIX-HEPB KFT. REF GROUP|Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
10835050|NCT00170157|BG000|Baseline|Entire Study Population|All participants initially randomized.
10835051|NCT00170157|FG000|Participant Flow|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
10835052|NCT00170157|FG001|Participant Flow|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily."
10835053|NCT00170157|OG000|Outcome|Entire Study Population|"All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.~."
10835054|NCT00170157|OG000|Outcome|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
10835055|NCT00170157|OG001|Outcome|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily"
10835056|NCT00170157|EG000|Reported Event|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
10835057|NCT00170625|BG000|Baseline|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
10835058|NCT00170625|FG000|Participant Flow|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21
10835059|NCT00170625|OG000|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
10835060|NCT00170625|EG000|Reported Event|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
10835061|NCT00170846|BG000|Baseline|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
10835062|NCT00170846|BG001|Baseline|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
10835063|NCT00170846|BG002|Baseline|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
10835064|NCT00170846|BG003|Baseline|Total|Total of all reporting groups
10835065|NCT00170846|FG000|Participant Flow|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
10835066|NCT00170846|FG001|Participant Flow|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
10835067|NCT00170846|FG002|Participant Flow|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
10835068|NCT00170846|OG000|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
10835069|NCT00170846|OG001|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
10835070|NCT00170846|OG002|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
10835071|NCT00170846|EG000|Reported Event|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
10835072|NCT00170846|EG001|Reported Event|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
10835073|NCT00170846|EG002|Reported Event|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
10835074|NCT00170950|BG000|Baseline|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835075|NCT00170950|BG001|Baseline|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835076|NCT00170950|BG002|Baseline|Total|Total of all reporting groups
10835077|NCT00170950|FG000|Participant Flow|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835078|NCT00170950|FG001|Participant Flow|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835079|NCT00170950|OG000|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835080|NCT00170950|OG001|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
10835081|NCT00170950|EG000|Reported Event|Benazepril / Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
10835082|NCT00170950|EG001|Reported Event|Benazepril / HCTZ|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily
10835083|NCT00171054|BG000|Baseline|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835084|NCT00171054|BG001|Baseline|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835085|NCT00171054|BG002|Baseline|Total|Total of all reporting groups
10835086|NCT00171054|FG000|Participant Flow|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835087|NCT00171054|FG001|Participant Flow|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835088|NCT00171054|OG000|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835089|NCT00171054|OG001|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835090|NCT00171054|EG000|Reported Event|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10835091|NCT00171054|EG001|Reported Event|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
10842856|NCT00249834|OG000|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842857|NCT00249834|OG001|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842858|NCT00249834|OG002|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842859|NCT00249834|OG003|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842860|NCT00249834|OG004|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842861|NCT00249834|EG000|Reported Event|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842862|NCT00249834|EG001|Reported Event|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10842863|NCT00249834|EG002|Reported Event|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10835092|NCT00171158|BG000|Baseline|Imatinib Mesylate (STI571)|Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
10835093|NCT00171158|FG000|Participant Flow|Imatinib Mesylate (STI571)|Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
10835094|NCT00171158|OG000|Outcome|Imatinib Mesylate (STI571)|Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
10835095|NCT00171158|EG000|Reported Event|Imatinib Mesylate (STI571)|Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
10835096|NCT00171210|BG000|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
10835097|NCT00171210|BG001|Baseline|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
10835098|NCT00171210|BG002|Baseline|Total|Total of all reporting groups
10835099|NCT00171210|FG000|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
10835100|NCT00171210|FG001|Participant Flow|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
10835101|NCT00171210|OG000|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
10835102|NCT00171210|OG001|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
10835103|NCT00171210|EG000|Reported Event|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight.
10835104|NCT00171210|EG001|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
10835105|NCT00171223|BG000|Baseline|Hematologic Failure|Participants failed to achieve a complete hematologic response, defined as lasting for at least 1 month despite 6 or more months of an interferon-alpha containing regimen, or had a rising WBC (to a level 20 x 10^9/L) confirmed by two samples taken at least two weeks apart after achieving a complete hematological response while receiving an interferon- alpha containing regimen of at least 25 MIU per week. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835106|NCT00171223|BG001|Baseline|Cytogenetic Failure|Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835107|NCT00171223|BG002|Baseline|Interferon-alpha Intolerance|Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835108|NCT00171223|BG003|Baseline|Total|Total of all reporting groups
10842864|NCT00249834|EG003|Reported Event|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10843312|NCT00253643|BG003|Baseline|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
10843313|NCT00253643|BG004|Baseline|Total|Total of all reporting groups
10835109|NCT00171223|FG000|Participant Flow|Hematologic Failure|Participants failed to achieve a complete hematologic response, defined as lasting for at least 1 month despite 6 or more months of an interferon-alpha containing regimen, or had a rising white blood cell count (WBC) [to a level 20 x 10^9/L] confirmed by two samples taken at least two weeks apart after achieving a complete hematological response while receiving an interferon- alpha containing regimen of at least 25 million international units (MIU) per week. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 milligrams (mg). During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835110|NCT00171223|FG001|Participant Flow|Cytogenetic Failure|Participants' bone marrow (BM) cytogenetics showed greater than or equal to (>=) 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835111|NCT00171223|FG002|Participant Flow|Interferon-alpha Intolerance|Participants demonstrated intolerance to interferon-alpha therapy defined as a documented greater than (>) Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835112|NCT00171223|OG000|Outcome|Hematologic Failure|Participants failed to achieve a complete hematologic response, defined as lasting for at least 1 month despite 6 or more months of an interferon-alpha containing regimen, or had a rising WBC (to a level 20 x 10^9/L) confirmed by two samples taken at least two weeks apart after achieving a complete hematological response while receiving an interferon- alpha containing regimen of at least 25 MIU per week. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835113|NCT00171223|OG001|Outcome|Cytogenetic Failure|Participants' BM cytogenetics showed >= 65% Philadelphia chromosome positivity after one year of an interferon-alpha containing regimen or an increase in the Philadelphia chromosome positive BM cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an increase to >= 65%. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835114|NCT00171223|OG002|Outcome|Interferon-alpha Intolerance|Participants demonstrated intolerance to interferon-alpha therapy defined as a documented > Grade 3 nonhematologic toxicity persisting for more than 1 month after receiving an interferon-alpha containing regimen of at least 25 MIU/week. Participants must have been more than 6 months from time of diagnosis. Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835115|NCT00171223|EG000|Reported Event|All Participants With Chronic Myeloid Leukemia|Participants received STI571, capsules or tablets, orally, once a day at a dose of 400 mg. During the Core Phase of the study, participants received STI571 daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study, and they continued STI571 for as long as the therapy was beneficial or until death, intolerable toxicity or the decision to discontinue by the investigator, whichever came first. (Maximum duration on study was approximately 14 years).
10835116|NCT00171249|BG000|Baseline|STI571|"Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.~Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported."
10835117|NCT00171249|FG000|Participant Flow|Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg|Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835118|NCT00171249|FG001|Participant Flow|Lymphoid Blast Crisis 400 mg|Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835119|NCT00171249|FG002|Participant Flow|Acute Lymphoblastic Leukemia 400 mg|Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835120|NCT00171249|FG003|Participant Flow|Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg|Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835121|NCT00171249|FG004|Participant Flow|Lymphoid Blast Crisis 600 mg|Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835122|NCT00171249|FG005|Participant Flow|Acute Lymphoblastic Leukemia 600 mg|Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835123|NCT00171249|FG006|Participant Flow|Acute Myeloid/Myelogenous Leukemia 600 mg|Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835124|NCT00171249|OG000|Outcome|Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg|Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835125|NCT00171249|OG001|Outcome|Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg|Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835126|NCT00171249|OG000|Outcome|Accelerated Phase Chronic Myeloid/Myelogenous Leukemia|Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835127|NCT00171249|OG001|Outcome|Lymphoid Blast Crisis|Participants with lymphoid blast crisis received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835128|NCT00171249|OG002|Outcome|Acute Lymphoid Leukemia|Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835129|NCT00171249|OG003|Outcome|Acute Myeloid/Myelogenous Leukemia|Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
10835130|NCT00171249|EG000|Reported Event|STI571|"Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.~Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported."
10835131|NCT00171301|BG000|Baseline|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835132|NCT00171301|BG001|Baseline|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835133|NCT00171301|BG002|Baseline|Total|Total of all reporting groups
10835134|NCT00171301|FG000|Participant Flow|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835135|NCT00171301|FG001|Participant Flow|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835136|NCT00171301|OG000|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835137|NCT00171301|OG001|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835138|NCT00171301|OG000|Outcome|Deferasirox (All Participants)|Participants received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835139|NCT00171301|EG000|Reported Event|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835140|NCT00171301|EG001|Reported Event|Deferasirox (16 Years or Older)|Participants age 16 years and older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
10835141|NCT00171314|BG000|Baseline|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835142|NCT00171314|BG001|Baseline|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835143|NCT00171314|BG002|Baseline|Total|Total of all reporting groups
10835144|NCT00171314|FG000|Participant Flow|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835145|NCT00171314|FG001|Participant Flow|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835146|NCT00171314|OG000|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835147|NCT00171314|OG001|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835148|NCT00171314|EG000|Reported Event|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
10835149|NCT00171314|EG001|Reported Event|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835150|NCT00171340|BG000|Baseline|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835151|NCT00171340|BG001|Baseline|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
11219757|NCT02329600|BG001|Baseline|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10835152|NCT00171340|BG002|Baseline|Total|Total of all reporting groups
10835153|NCT00171340|FG000|Participant Flow|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835154|NCT00171340|FG001|Participant Flow|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
11328554|NCT03429348|OG000|Outcome|Baseline No Additional Rehabilitation Group Urine PAH-OH Sum|Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed with gas chromatography mass spectroscopy (GC-MS). The sum of the PAH-OHs was determined for the baseline control group samples.
11328555|NCT03429348|OG001|Outcome|Post-fire No Additional Rehabilitation Group|Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the post-fire samples for the control group.
10835155|NCT00171340|OG000|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835156|NCT00171340|OG001|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835157|NCT00171340|OG000|Outcome|Zolendronic Acid 4 mg Upfront|
10835158|NCT00171340|OG001|Outcome|Zolendronic Acid 4 mg Delayed|
10835159|NCT00171340|EG000|Reported Event|Zoledronic Acid 4mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1 and Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835160|NCT00171340|EG001|Reported Event|Zolendronic Acid 4mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
10835161|NCT00171704|BG000|Baseline|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
10835162|NCT00171704|BG001|Baseline|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
10835163|NCT00171704|BG002|Baseline|Total|Total of all reporting groups
10835164|NCT00171704|FG000|Participant Flow|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
10835165|NCT00171704|FG001|Participant Flow|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
10835166|NCT00171704|OG000|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
10835167|NCT00171704|OG001|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
10835168|NCT00171704|EG000|Reported Event|Letrozole|2.5 mg once daily q.d. orally for 5 years
10835169|NCT00171704|EG001|Reported Event|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
10835170|NCT00171730|BG000|Baseline|Pasireotide s.c. Overall|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
10835171|NCT00171730|FG000|Participant Flow|Pasireotide s.c. Overall|Participants received pasireotide as a daily subcutaneous (s.c.) injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
10835172|NCT00171730|OG000|Outcome|Pasireotide s.c. <1200 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose <1200 μg/day with median duration of 2.1 months.
10835173|NCT00171730|OG001|Outcome|Pasireotide s.c. 1200 to <1500 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose 1200 to <1500 μg/day with median duration of 6.4 months.
10835174|NCT00171730|OG002|Outcome|Pasireotide s.c. ≥1500 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose ≥ 1500 μg/day with median duration of 16.6 months.
10835175|NCT00171730|OG003|Outcome|Pasireotide s.c. Overall|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
10835176|NCT00171730|OG000|Outcome|Pasireotide s.c. Overall|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
11328556|NCT03429348|OG002|Outcome|Baseline Sauna Rehabilitation Group Urine PAH-OH Sum|Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the baseline sauna group.
10835177|NCT00171730|EG000|Reported Event|Pasireotide s.c. <1200 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose <1200 μg/day with median duration of 2.1 months.
10835178|NCT00171730|EG001|Reported Event|Pasireotide s.c. 1200 to <1500 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose 1200 to <1500 μg/day with median duration of 6.4 months.
10835179|NCT00171730|EG002|Reported Event|Pasireotide s.c. ≥1500 μg/d|Participants received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 μg), with total daily dose ≥ 1500 μg/day with median duration of 16.6 months.
10835180|NCT00171834|BG000|Baseline|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835181|NCT00171834|BG001|Baseline|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835182|NCT00171834|BG002|Baseline|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835183|NCT00171834|BG003|Baseline|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835184|NCT00171834|BG004|Baseline|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835185|NCT00171834|BG005|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
10835186|NCT00171834|BG006|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
10835187|NCT00171834|BG007|Baseline|Total|Total of all reporting groups
10835188|NCT00171834|FG000|Participant Flow|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835189|NCT00171834|FG001|Participant Flow|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835190|NCT00171834|FG002|Participant Flow|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
11328557|NCT03429348|OG003|Outcome|Post-fire Sauna Rehabilitation Group|Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the post-fire sauna group.
10835191|NCT00171834|FG003|Participant Flow|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
11328558|NCT03429348|EG000|Reported Event|No Additional Rehabilitation|No additional rehabilitation will be done
11328559|NCT03429348|EG001|Reported Event|Sauna Rehabilitation|"An additional rehabilitation in a sauna will be done~Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna"
11328560|NCT03429556|BG000|Baseline|Placebo|Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
11328561|NCT03429556|BG001|Baseline|Botulinum Neurotoxin Serotype E Dose 1|Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
11328562|NCT03429556|BG002|Baseline|Botulinum Neurotoxin Serotype E Dose 2|Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
10835192|NCT00171834|FG004|Participant Flow|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
11328563|NCT03429556|BG003|Baseline|Botulinum Neurotoxin Serotype E Dose 3|Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
10835193|NCT00171834|FG005|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
11328564|NCT03429556|BG004|Baseline|Total|Total of all reporting groups
11328565|NCT03429556|FG000|Participant Flow|Placebo|Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into rectus abdominus (RA) muscles during abdominoplasty surgery.
11328566|NCT03429556|FG001|Participant Flow|Botulinum Neurotoxin Serotype E Dose 1|Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
10835194|NCT00171834|FG006|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
11328567|NCT03429556|FG002|Participant Flow|Botulinum Neurotoxin Serotype E Dose 2|Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
10835195|NCT00171834|OG000|Outcome|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835196|NCT00171834|OG001|Outcome|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835197|NCT00171834|OG002|Outcome|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835198|NCT00171834|OG003|Outcome|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835199|NCT00171834|OG004|Outcome|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835200|NCT00171834|OG000|Outcome|Patupilone (EPO906) Phase I|
10835201|NCT00171834|OG001|Outcome|Patupilone (EPO906) Phase II|
10835202|NCT00171834|OG000|Outcome|Patupilone 6.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835203|NCT00171834|OG001|Outcome|Patupilone 7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835204|NCT00171834|OG002|Outcome|Patupilone 7.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835205|NCT00171834|OG003|Outcome|Patupilone 8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835206|NCT00171834|OG004|Outcome|Patupilone 8.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835207|NCT00171834|OG005|Outcome|Patupilone 9.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835208|NCT00171834|OG006|Outcome|Patupilone 9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
11328568|NCT03429556|FG003|Participant Flow|Botulinum Neurotoxin Serotype E Dose 3|Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
10835209|NCT00171834|OG007|Outcome|Patupilone 10.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835210|NCT00171834|OG008|Outcome|Patupilone 10.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835211|NCT00171834|OG009|Outcome|Patupilone 11.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835212|NCT00171834|OG010|Outcome|Patupilone 11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835213|NCT00171834|OG011|Outcome|Patupilone 12.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835214|NCT00171834|OG012|Outcome|Patupilone 13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835215|NCT00171834|OG000|Outcome|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
10835216|NCT00171834|EG000|Reported Event|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835217|NCT00171834|EG001|Reported Event|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835218|NCT00171834|EG002|Reported Event|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835219|NCT00171834|EG003|Reported Event|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835220|NCT00171834|EG004|Reported Event|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
10835221|NCT00171834|EG005|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
10835222|NCT00171834|EG006|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
10835223|NCT00171873|BG000|Baseline|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
10835224|NCT00171873|BG001|Baseline|Placebo|Sodium chloride intramuscularly every 28 days
10835225|NCT00171873|BG002|Baseline|Total|Total of all reporting groups
10835226|NCT00171873|FG000|Participant Flow|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
10835227|NCT00171873|FG001|Participant Flow|Placebo|Sodium chloride intramuscularly every 28 days
10835228|NCT00171873|OG000|Outcome|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
10835229|NCT00171873|OG001|Outcome|Placebo|Sodium chloride intramuscularly every 28 days
10835230|NCT00171873|EG000|Reported Event|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
10835231|NCT00171873|EG001|Reported Event|Placebo|Sodium chloride intramuscularly every 28 days
10835232|NCT00171925|BG000|Baseline|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
10835233|NCT00171925|BG001|Baseline|Control|No Treatment with study medication.
10835234|NCT00171925|BG002|Baseline|Total|Total of all reporting groups
10835235|NCT00171925|FG000|Participant Flow|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
10835236|NCT00171925|FG001|Participant Flow|Control|No Treatment with study medication.
10835237|NCT00171925|OG000|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
10835238|NCT00171925|OG001|Outcome|Control|No Treatment with study medication.
10835239|NCT00171925|EG000|Reported Event|Zoledronic Acid|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
10835240|NCT00171925|EG001|Reported Event|Control|No treatment with study medication.
10835241|NCT00171951|BG000|Baseline|Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC|Participants received pasireotide 600 μg BID SC to achieve or maintain UFC normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
10835242|NCT00171951|FG000|Participant Flow|Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC|Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
10835243|NCT00171951|OG000|Outcome|Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC|Participants received pasireotide 600 μg BID SC to achieve or maintain UFC normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
10835244|NCT00171951|OG000|Outcome|Pasireotide 600 μg BID SC|Participants received pasireotide 600 μg BID SC, to achieve or maintain UFC normalization.
10835245|NCT00171951|OG001|Outcome|Pasireotide 900 μg BID SC|Participants received 900 μg BID SC if UFC levels were increased at any time, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
10835246|NCT00171951|EG000|Reported Event|Pasireotide 600 μg BID SC|Participants received pasireotide 600 μg BID SC, to achieve or maintain UFC normalization.
10835247|NCT00171951|EG001|Reported Event|Pasireotide 900 μg BID SC|Participants received 900 μg BID SC if UFC levels were increased at any time, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
10835248|NCT00172042|BG000|Baseline|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
10835249|NCT00172042|BG001|Baseline|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
10835250|NCT00172042|BG002|Baseline|Total|Total of all reporting groups
10835251|NCT00172042|FG000|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
10835252|NCT00172042|FG001|Participant Flow|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
10835253|NCT00172042|OG000|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
10835254|NCT00172042|OG001|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
10835255|NCT00172042|EG000|Reported Event|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
10835256|NCT00172042|EG001|Reported Event|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
10835257|NCT00172185|BG000|Baseline|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835258|NCT00172185|BG001|Baseline|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835259|NCT00172185|BG002|Baseline|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835260|NCT00172185|BG003|Baseline|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835261|NCT00172185|BG004|Baseline|Total|Total of all reporting groups
10835262|NCT00172185|FG000|Participant Flow|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835263|NCT00172185|FG001|Participant Flow|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835264|NCT00172185|FG002|Participant Flow|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835265|NCT00172185|FG003|Participant Flow|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835266|NCT00172185|OG000|Outcome|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835267|NCT00172185|OG001|Outcome|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835268|NCT00172185|OG002|Outcome|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
10835269|NCT00172185|OG003|Outcome|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
10835270|NCT00172185|OG000|Outcome|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
10835271|NCT00172185|OG001|Outcome|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
10835272|NCT00172185|OG002|Outcome|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
10835273|NCT00172185|OG003|Outcome|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
10835274|NCT00172185|EG000|Reported Event|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
10835275|NCT00172185|EG001|Reported Event|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
10835276|NCT00172185|EG002|Reported Event|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
10835277|NCT00172185|EG003|Reported Event|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
10835278|NCT00174187|BG000|Baseline|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835279|NCT00174187|BG001|Baseline|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835280|NCT00174187|BG002|Baseline|Total|Total of all reporting groups
10835281|NCT00174187|FG000|Participant Flow|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835282|NCT00174187|FG001|Participant Flow|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835283|NCT00174187|FG002|Participant Flow|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835284|NCT00174187|OG000|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835285|NCT00174187|OG001|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
10835286|NCT00174187|OG000|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835287|NCT00174187|EG000|Reported Event|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
11328569|NCT03429556|OG000|Outcome|Placebo|Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
10835288|NCT00174187|EG001|Reported Event|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
11328570|NCT03429556|OG001|Outcome|Botulinum Neurotoxin Serotype E Dose 1|Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
10835289|NCT00174187|EG002|Reported Event|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835290|NCT00174252|BG000|Baseline|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
10835291|NCT00174252|FG000|Participant Flow|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
10835292|NCT00174252|OG000|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
10835293|NCT00174252|OG000|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
10835294|NCT00174252|OG001|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
10835295|NCT00174252|EG000|Reported Event|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
10835296|NCT00174291|BG000|Baseline|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835297|NCT00174291|BG001|Baseline|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835298|NCT00174291|BG002|Baseline|Total|Total of all reporting groups
10835299|NCT00174291|FG000|Participant Flow|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835300|NCT00174291|FG001|Participant Flow|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835301|NCT00174291|OG000|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835302|NCT00174291|OG001|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835303|NCT00174291|EG000|Reported Event|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835304|NCT00174291|EG001|Reported Event|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
10835305|NCT00174382|BG000|Baseline|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
10835306|NCT00174382|FG000|Participant Flow|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
10835307|NCT00174382|OG000|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
10835308|NCT00174382|EG000|Reported Event|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
10835309|NCT00174447|BG000|Baseline|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
10835310|NCT00174447|FG000|Participant Flow|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
10835311|NCT00174447|OG000|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
10835312|NCT00174447|EG000|Reported Event|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
10835313|NCT00174460|BG000|Baseline|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
10835314|NCT00174460|BG001|Baseline|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
10835315|NCT00174460|BG002|Baseline|Total|Total of all reporting groups
10835316|NCT00174460|FG000|Participant Flow|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
10835317|NCT00174460|FG001|Participant Flow|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
10835318|NCT00174460|OG000|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
10835319|NCT00174460|OG001|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
10835320|NCT00174460|OG000|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
10835321|NCT00174460|EG000|Reported Event|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
10835322|NCT00174460|EG001|Reported Event|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
10835323|NCT00174785|BG000|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
10835324|NCT00174785|BG001|Baseline|Placebo|matching placebo tablets
10835325|NCT00174785|BG002|Baseline|Total|Total of all reporting groups
10835326|NCT00174785|FG000|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
10835327|NCT00174785|FG001|Participant Flow|Placebo|matching placebo tablets
10835328|NCT00174785|OG000|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
11328571|NCT03429556|OG002|Outcome|Botulinum Neurotoxin Serotype E Dose 2|Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
10835329|NCT00174785|OG001|Outcome|Placebo|matching placebo tablets
10835330|NCT00174785|EG000|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
10835331|NCT00174785|EG001|Reported Event|Placebo|matching placebo tablets
10835332|NCT00174915|BG000|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
10835333|NCT00174915|BG001|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
10835334|NCT00174915|BG002|Baseline|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
10835335|NCT00174915|BG003|Baseline|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
10835336|NCT00174915|BG004|Baseline|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
10835337|NCT00174915|BG005|Baseline|Total|Total of all reporting groups
10835338|NCT00174915|FG000|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
10835339|NCT00174915|FG001|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
10835340|NCT00174915|FG002|Participant Flow|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
10835341|NCT00174915|FG003|Participant Flow|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
10835342|NCT00174915|FG004|Participant Flow|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
10835343|NCT00174915|OG000|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
10835344|NCT00174915|OG001|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
10835345|NCT00174915|OG002|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
10835346|NCT00174915|OG003|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
10835347|NCT00174915|OG004|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
10835348|NCT00174915|EG000|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
10835349|NCT00174915|EG001|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
10835350|NCT00174915|EG002|Reported Event|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
10835351|NCT00174915|EG003|Reported Event|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
10835352|NCT00174915|EG004|Reported Event|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
10835353|NCT00174941|BG000|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg orally, once daily, based on serum urate level.
10835354|NCT00174941|BG001|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level
10835355|NCT00174941|BG002|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level
10835356|NCT00174941|BG003|Baseline|Total|Total of all reporting groups
10835357|NCT00174941|FG000|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
10835358|NCT00174941|FG001|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
10835359|NCT00174941|FG002|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
10835360|NCT00174941|FG003|Participant Flow|Total Febuxostat|
10835361|NCT00174941|OG000|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
10835362|NCT00174941|OG001|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
10835363|NCT00174941|OG002|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
10835364|NCT00174941|OG003|Outcome|Total Febuxostat|
10835365|NCT00174941|EG000|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg taken orally, once daily, based on serum urate level.
10835366|NCT00174941|EG001|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily, based on serum urate level
10835367|NCT00174941|EG002|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily, based on serum urate level
10835368|NCT00174941|EG003|Reported Event|Febuxostat Total|
10835369|NCT00174954|BG000|Baseline|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
10835370|NCT00174954|FG000|Participant Flow|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
10835371|NCT00174954|OG000|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
10835372|NCT00174954|EG000|Reported Event|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
10835373|NCT00174967|BG000|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
10835374|NCT00174967|BG001|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
10835375|NCT00174967|BG002|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
10835376|NCT00174967|BG003|Baseline|Placebo QD|Placebo, orally, once daily
10835377|NCT00174967|BG004|Baseline|Total|Total of all reporting groups
10835378|NCT00174967|FG000|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
10835379|NCT00174967|FG001|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
10835380|NCT00174967|FG002|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
10835381|NCT00174967|FG003|Participant Flow|Placebo QD|Placebo, orally, once daily
10835382|NCT00174967|OG000|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
10835383|NCT00174967|OG001|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
10835384|NCT00174967|OG002|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
10835385|NCT00174967|OG003|Outcome|Placebo QD|Placebo, orally, once daily
10835386|NCT00174967|EG000|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
10835387|NCT00174967|EG001|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
10835388|NCT00174967|EG002|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
10835389|NCT00174967|EG003|Reported Event|Placebo QD|Placebo, orally, once daily
10835390|NCT00175006|BG000|Baseline|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
10835391|NCT00175006|FG000|Participant Flow|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
10835392|NCT00175006|OG000|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
10835393|NCT00175006|EG000|Reported Event|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
10835394|NCT00175019|BG000|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
10835395|NCT00175019|BG001|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
10835396|NCT00175019|BG002|Baseline|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
10835397|NCT00175019|BG003|Baseline|Total|Total of all reporting groups
10835398|NCT00175019|FG000|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
10835399|NCT00175019|FG001|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
10835400|NCT00175019|FG002|Participant Flow|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
10835401|NCT00175019|OG000|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
10835402|NCT00175019|OG001|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
10835403|NCT00175019|OG002|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
10835404|NCT00175019|EG000|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
10835405|NCT00175019|EG001|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
10835406|NCT00175019|EG002|Reported Event|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
10835407|NCT00175825|BG000|Baseline|Placebo|Matching Placebo tablets administered twice a day
10835408|NCT00175825|BG001|Baseline|Brivaracetam 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10835409|NCT00175825|BG002|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10835410|NCT00175825|BG003|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10835411|NCT00175825|BG004|Baseline|Total Title|
10835412|NCT00175825|FG000|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
10835413|NCT00175825|FG001|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10835414|NCT00175825|FG002|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10835415|NCT00175825|FG003|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10835416|NCT00175825|OG000|Outcome|Placebo|Matching Placebo tablets administered twice a day
10835417|NCT00175825|OG001|Outcome|Brivaracetam 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10835418|NCT00175825|OG002|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10835419|NCT00175825|OG003|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10835420|NCT00175825|EG000|Reported Event|Placebo|Matching Placebo tablets administered twice a day
10835421|NCT00175825|EG001|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
10835422|NCT00175825|EG002|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
10835423|NCT00175825|EG003|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
10835424|NCT00175877|BG000|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10835425|NCT00175877|FG000|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10835426|NCT00175877|OG000|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
10835427|NCT00175877|EG000|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
11328572|NCT03429556|OG003|Outcome|Botulinum Neurotoxin Serotype E Dose 3|Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
11328573|NCT03429556|EG000|Reported Event|Placebo|Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
10835428|NCT00175916|BG000|Baseline|Brivaracetam|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
10835429|NCT00175916|FG000|Participant Flow|Brivaracetam|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
10835430|NCT00175916|OG000|Outcome|Brivaracetam (SS)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
10835431|NCT00175916|OG000|Outcome|Brivaracetam (POS Efficacy)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).
10835432|NCT00175916|EG000|Reported Event|Brivaracetam (SS)|Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
10835433|NCT00176202|BG000|Baseline|Risperidone|"Risperidone is an antipsychotic medication and is used to treat mania. Its trade name is Risperdal.~Aim of the study is to cross compare the relative efficacy and safety of risperidone and divalproex sodium in treating/stabilizing mania in pediatric bipolar disorder."
10835434|NCT00176202|BG001|Baseline|Divalproex|Divalproex sodium, also referred to as divalproex is an antiepileptic medication used for mania and is referred to as mood stabilizer. Its trade name is Depakote.
10835435|NCT00176202|BG002|Baseline|Total|Total of all reporting groups
10835436|NCT00176202|FG000|Participant Flow|Risperidone|The study aimed to compare the antipsychotic medication i.e., risperidone's efficacy with that of divalproex sodium (which is an antiepileptic medication) in treating/stabilizing pediatric bipolar disorder.
10835437|NCT00176202|FG001|Participant Flow|Divalproex Sodium|This is antiepileptic medication and is a comparator drug to see if it is as efficacious as risperidone assumption is both have equal efficacy with no difference between the two.
10835438|NCT00176202|OG000|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80-120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
10835439|NCT00176202|OG001|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25-0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
10835440|NCT00176202|OG000|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
10835441|NCT00176202|OG001|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
10835442|NCT00176202|EG000|Reported Event|Risperidone|"Likely side effects include weight gain, muscle stiffness, sedation and tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
10835443|NCT00176202|EG001|Reported Event|Depakote or Divalproex Sodium|"Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
10835444|NCT00176228|BG000|Baseline|Lamotrigine|upto 200 mg
10835445|NCT00176228|FG000|Participant Flow|Lamotrigine|upto 200 mg
10835446|NCT00176228|OG000|Outcome|Lamotrigine Effectiveness on YMRS (Mania Measure)|
10835447|NCT00176228|OG000|Outcome|Lamotrigine|Lamotrigine: Response on CDRS-R
10835448|NCT00176228|EG000|Reported Event|Lamotrigine|upto 200 mg
10835449|NCT00176254|BG000|Baseline|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
10835450|NCT00176254|FG000|Participant Flow|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m^2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
10835451|NCT00176254|OG000|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
10835452|NCT00176254|EG000|Reported Event|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
10835453|NCT00176306|BG000|Baseline|Levofloxacin Arm|patients receiving levofloxacin
10835454|NCT00176306|FG000|Participant Flow|Levofloxacin Arm|Patients receive commercially available levofloxacin 750mg solution for intravnous use
10835455|NCT00176306|OG000|Outcome|Levofloxacin Arm|Subjects receiving levofloxacin
10835456|NCT00176306|EG000|Reported Event|Levofloxacin Arm|patients receiving levofloxacin
10835457|NCT00176423|BG000|Baseline|Galantamine|"galantamine, 24mgs, p.o., qday~galantamine: see arm/group description"
10835458|NCT00176423|BG001|Baseline|Placebo|"placebo, 3 tablets, p.o., qday~galantamine: see arm/group description"
10835459|NCT00176423|BG002|Baseline|Total|Total of all reporting groups
11219758|NCT02329600|BG002|Baseline|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219759|NCT02329600|BG003|Baseline|Total|Total of all reporting groups
10835460|NCT00176423|FG000|Participant Flow|Galantamine|galantamine, 24mgs, p.o., qday
11219760|NCT02329600|FG000|Participant Flow|Control Subjects|10 systemically healthy control subjects taking no medication.
11219761|NCT02329600|FG001|Participant Flow|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219762|NCT02329600|FG002|Participant Flow|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219763|NCT02329600|OG000|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
11219764|NCT02329600|OG001|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219765|NCT02329600|OG002|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219766|NCT02329600|EG000|Reported Event|Control Subjects|10 systemically healthy control subjects taking no medication.
11219767|NCT02329600|EG001|Reported Event|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219768|NCT02329600|EG002|Reported Event|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
11219769|NCT02329730|BG000|Baseline|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11328574|NCT03429556|EG001|Reported Event|Botulinum Neurotoxin Serotype E Dose 1|Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
11328575|NCT03429556|EG002|Reported Event|Botulinum Neurotoxin Serotype E Dose 2|Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
10835461|NCT00176423|FG001|Participant Flow|Placebo|placebo, 3 tablets, p.o., qday
10835462|NCT00176423|OG000|Outcome|Galantamine|"galantamine, 24mgs, p.o., qday~galantamine: see arm/group description"
10835463|NCT00176423|OG001|Outcome|Placebo|"placebo, 3 tablets, p.o., qday~galantamine: see arm/group description"
10835464|NCT00176423|EG000|Reported Event|Galantamine|"galantamine, 24mgs, p.o., qday~galantamine: see arm/group description"
10835465|NCT00176423|EG001|Reported Event|Placebo|"placebo, 3 tablets, p.o., qday~galantamine: see arm/group description"
10835466|NCT00176462|BG000|Baseline|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
10835467|NCT00176462|BG001|Baseline|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
10835468|NCT00176462|BG002|Baseline|Total|Total of all reporting groups
10835469|NCT00176462|FG000|Participant Flow|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
10835470|NCT00176462|FG001|Participant Flow|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
10835471|NCT00176462|OG000|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
10835472|NCT00176462|OG000|Outcome|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
10835473|NCT00176462|OG001|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
10835474|NCT00176462|EG000|Reported Event|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
10835475|NCT00176462|EG001|Reported Event|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
10835476|NCT00176592|BG000|Baseline|Betaseron|"Betaseron 250 micrograms SQ every other day~Betaseron: Betaseron 250 micrograms injected SQ every other day"
10835477|NCT00176592|BG001|Baseline|Copaxone|"20 mg daily SQ~Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)"
10835478|NCT00176592|BG002|Baseline|Total|Total of all reporting groups
10835479|NCT00176592|FG000|Participant Flow|Betaseron|"Betaseron 250 micrograms SQ every other day~Betaseron: Betaseron 250 micrograms injected SQ every other day"
10835480|NCT00176592|FG001|Participant Flow|Copaxone|"20 mg daily SQ~Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)"
10835481|NCT00176592|OG000|Outcome|Betaseron|"Betaseron 250 micrograms SQ every other day~Betaseron: Betaseron 250 micrograms injected SQ every other day"
10835482|NCT00176592|OG001|Outcome|Copaxone|"20 mg daily SQ~Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)"
10835483|NCT00176592|EG000|Reported Event|Betaseron|"Betaseron 250 micrograms SQ every other day~Betaseron: Betaseron 250 micrograms injected SQ every other day"
10835484|NCT00176592|EG001|Reported Event|Copaxone|"20 mg daily SQ~Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)"
10835485|NCT00176605|BG000|Baseline|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
10835486|NCT00176605|FG000|Participant Flow|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
10835487|NCT00176605|OG000|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
10842865|NCT00249834|EG004|Reported Event|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
10835488|NCT00176605|EG000|Reported Event|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
10835489|NCT00176644|BG000|Baseline|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
10835490|NCT00176644|FG000|Participant Flow|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
10835491|NCT00176644|OG000|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
10835492|NCT00176644|EG000|Reported Event|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
10835493|NCT00176800|BG000|Baseline|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
10835494|NCT00176800|FG000|Participant Flow|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
10835495|NCT00176800|OG000|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
10835496|NCT00176800|EG000|Reported Event|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
10835497|NCT00176826|BG000|Baseline|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
10835498|NCT00176826|FG000|Participant Flow|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
10835499|NCT00176826|OG000|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
10835500|NCT00176826|EG000|Reported Event|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
10835501|NCT00176839|BG000|Baseline|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
10835502|NCT00176839|FG000|Participant Flow|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
10835503|NCT00176839|OG000|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
10835504|NCT00176839|EG000|Reported Event|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
10835505|NCT00176852|BG000|Baseline|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
10835506|NCT00176852|BG001|Baseline|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835507|NCT00176852|BG002|Baseline|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835508|NCT00176852|BG003|Baseline|Total|Total of all reporting groups
10835509|NCT00176852|FG000|Participant Flow|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
10835510|NCT00176852|FG001|Participant Flow|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835511|NCT00176852|FG002|Participant Flow|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835512|NCT00176852|OG000|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
10835513|NCT00176852|OG001|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835514|NCT00176852|OG002|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835515|NCT00176852|EG000|Reported Event|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
10835516|NCT00176852|EG001|Reported Event|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835517|NCT00176852|EG002|Reported Event|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
10835518|NCT00176865|BG000|Baseline|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835519|NCT00176865|BG001|Baseline|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835520|NCT00176865|BG002|Baseline|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835521|NCT00176865|BG003|Baseline|Total|Total of all reporting groups
10835522|NCT00176865|FG000|Participant Flow|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835523|NCT00176865|FG001|Participant Flow|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835524|NCT00176865|FG002|Participant Flow|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835525|NCT00176865|OG000|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835526|NCT00176865|OG001|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835527|NCT00176865|OG002|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835528|NCT00176865|EG000|Reported Event|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835529|NCT00176865|EG001|Reported Event|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835530|NCT00176865|EG002|Reported Event|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
10835531|NCT00176878|BG000|Baseline|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
10835532|NCT00176878|FG000|Participant Flow|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
10835533|NCT00176878|OG000|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
10835534|NCT00176878|EG000|Reported Event|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
10835535|NCT00176891|BG000|Baseline|Laronidase ERT Treatment|"Weekly infusion of laronidase enzyme replacement therapy followed by hematopoietic stem cell transplant.~Stem Cell Transplant: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following~Laronidase ERT: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following."
10835536|NCT00176891|FG000|Participant Flow|Laronidase ERT Treatment|"Weekly infusion of laronidase enzyme replacement therapy followed by hematopoietic stem cell transplant.~Stem Cell Transplant: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following~Laronidase ERT: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following."
10835537|NCT00176891|OG000|Outcome|Laronidase ERT Treatment|"Weekly infusion of laronidase enzyme replacement therapy followed by hematopoietic stem cell transplant.~Stem Cell Transplant: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following~Laronidase ERT: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following."
10835538|NCT00176891|EG000|Reported Event|Laronidase ERT Treatment|"Weekly infusion of laronidase enzyme replacement therapy followed by hematopoietic stem cell transplant.~Stem Cell Transplant: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following~Laronidase ERT: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following."
10835539|NCT00176904|BG000|Baseline|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
10835540|NCT00176904|FG000|Participant Flow|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
10835541|NCT00176904|OG000|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
10835542|NCT00176904|EG000|Reported Event|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
10835543|NCT00176917|BG000|Baseline|Transplant Patients|Patients that received hematopoietic stem cell transplant.
10835544|NCT00176917|FG000|Participant Flow|Transplant Patients|Patients that received hematopoietic stem cell transplant.
10835545|NCT00176917|OG000|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
10835546|NCT00176917|EG000|Reported Event|Transplant Patients|Patients that received hematopoietic stem cell transplant.
10835547|NCT00176930|BG000|Baseline|PBSC: No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
10835548|NCT00176930|BG001|Baseline|Marrow : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
10835549|NCT00176930|BG002|Baseline|UCB : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835550|NCT00176930|BG003|Baseline|UCB : No TBI/Bu/Cy/ATG|Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
10835551|NCT00176930|BG004|Baseline|PBSC|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
10835552|NCT00176930|BG005|Baseline|Marrow|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
10835553|NCT00176930|BG006|Baseline|Umbilical Cord Blood|Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835554|NCT00176930|BG007|Baseline|Co-Enroll From MT0403|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
10835555|NCT00176930|BG008|Baseline|Total|Total of all reporting groups
10835556|NCT00176930|FG000|Participant Flow|PBSC: No TBI|"Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours."
10835557|NCT00176930|FG001|Participant Flow|Marrow : No TBI|"Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours."
10835558|NCT00176930|FG002|Participant Flow|UCB : No TBI|"Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours."
10835559|NCT00176930|FG003|Participant Flow|UCB : No TBI/Bu/Cy/ATG|"Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.~Equine ATG (ATGAM): UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines"
10835560|NCT00176930|FG004|Participant Flow|PBSC|"Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily."
10835561|NCT00176930|FG005|Participant Flow|Marrow|"Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily."
10835562|NCT00176930|FG006|Participant Flow|Umbilical Cord Blood|"Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily."
10835563|NCT00176930|FG007|Participant Flow|Co-Enroll From MT0403|"Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)~Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.~Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily. CD4+/CD25+ cells: On days -2, patients will receive CD4+/CD25+ cells intravenously."
10835564|NCT00176930|OG000|Outcome|PBSC: No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
10835565|NCT00176930|OG001|Outcome|Marrow : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
10835566|NCT00176930|OG002|Outcome|UCB : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835567|NCT00176930|OG003|Outcome|UCB : No TBI/Bu/Cy/ATG|Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
10835568|NCT00176930|OG004|Outcome|PBSC|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
10835569|NCT00176930|OG005|Outcome|Marrow|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
10835570|NCT00176930|OG006|Outcome|Umbilical Cord Blood|Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835571|NCT00176930|OG007|Outcome|Co-Enroll From MT0403|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
10835572|NCT00176930|EG000|Reported Event|PBSC: No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
10835573|NCT00176930|EG001|Reported Event|Marrow : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
10835574|NCT00176930|EG002|Reported Event|UCB : No TBI|Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835575|NCT00176930|EG003|Reported Event|UCB : No TBI/Bu/Cy/ATG|Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
10835576|NCT00176930|EG004|Reported Event|PBSC|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
10835577|NCT00176930|EG005|Reported Event|Marrow|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
10835578|NCT00176930|EG006|Reported Event|Umbilical Cord Blood|Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
10835579|NCT00176930|EG007|Reported Event|Co-Enroll From MT0403|Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
10835580|NCT00177047|BG000|Baseline|Chemotherapy and Transplant Treatment|Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
10835581|NCT00177047|FG000|Participant Flow|Chemotherapy and Transplant Treatment|Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
10835582|NCT00177047|OG000|Outcome|Chemotherapy and Transplant Treatment|Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
10835583|NCT00177047|EG000|Reported Event|Chemotherapy and Transplant Treatment|"Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.~Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.~Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.~Melphalan: Administered intravenously 200 mg/m^2~Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant."
10835584|NCT00177164|BG000|Baseline|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
10835585|NCT00177164|BG001|Baseline|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
10835586|NCT00177164|BG002|Baseline|Total|Total of all reporting groups
10835587|NCT00177164|FG000|Participant Flow|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
10835588|NCT00177164|FG001|Participant Flow|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
10835589|NCT00177164|OG000|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
10835590|NCT00177164|OG001|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
10835591|NCT00177164|EG000|Reported Event|Risperidone LAI|
10835592|NCT00177164|EG001|Reported Event|Oral AAP|
10835593|NCT00177216|BG000|Baseline|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
10835594|NCT00177216|BG001|Baseline|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
10835595|NCT00177216|BG002|Baseline|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
10835596|NCT00177216|BG003|Baseline|Total|Total of all reporting groups
10835597|NCT00177216|FG000|Participant Flow|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
10835598|NCT00177216|FG001|Participant Flow|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
10835599|NCT00177216|FG002|Participant Flow|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
10835600|NCT00177216|OG000|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
10835601|NCT00177216|OG001|Outcome|Escitalpram|Participants receiving an antidepressant, escitalopram
10835602|NCT00177216|OG002|Outcome|Placebo|Participants receiving a placebo
10835603|NCT00177216|OG000|Outcome|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
10835604|NCT00177216|OG001|Outcome|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
10835605|NCT00177216|OG002|Outcome|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
10835606|NCT00177216|OG001|Outcome|Escitalopram|Participants receiving an antidepressant, escitalopram
10835607|NCT00177216|EG000|Reported Event|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
10835608|NCT00177216|EG001|Reported Event|Escitalopram|Participants receiving an antidepressant, escitalopram
10835609|NCT00177216|EG002|Reported Event|Placebo|Participants receiving a placebo
10835610|NCT00177255|BG000|Baseline|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
10835611|NCT00177255|FG000|Participant Flow|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
10835612|NCT00177255|OG000|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
10842866|NCT00249873|BG000|Baseline|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
10842867|NCT00249873|BG001|Baseline|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
10842868|NCT00249873|BG002|Baseline|Total|Total of all reporting groups
10842869|NCT00249873|FG000|Participant Flow|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
10835613|NCT00177255|EG000|Reported Event|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
10835614|NCT00177294|BG000|Baseline|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
10835615|NCT00177294|BG001|Baseline|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
10835616|NCT00177294|BG002|Baseline|Total|Total of all reporting groups
10835617|NCT00177294|FG000|Participant Flow|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
10835618|NCT00177294|FG001|Participant Flow|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
10835619|NCT00177294|OG000|Outcome|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
10835620|NCT00177294|OG001|Outcome|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
10835621|NCT00177294|EG000|Reported Event|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
10835622|NCT00177294|EG001|Reported Event|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
10835623|NCT00177307|BG000|Baseline|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
10835624|NCT00177307|FG000|Participant Flow|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
10835625|NCT00177307|OG000|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
10835626|NCT00177307|EG000|Reported Event|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
10835627|NCT00177671|BG000|Baseline|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
10835628|NCT00177671|BG001|Baseline|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
10835629|NCT00177671|BG002|Baseline|Total|Total of all reporting groups
10835630|NCT00177671|FG000|Participant Flow|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
10835631|NCT00177671|FG001|Participant Flow|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
10835632|NCT00177671|OG000|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
10835633|NCT00177671|OG001|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
10835634|NCT00177671|EG000|Reported Event|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
10835635|NCT00177671|EG001|Reported Event|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
10835636|NCT00178126|BG000|Baseline|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
10835637|NCT00178126|BG001|Baseline|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
10835638|NCT00178126|BG002|Baseline|Total|Total of all reporting groups
10835639|NCT00178126|FG000|Participant Flow|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
10835640|NCT00178126|FG001|Participant Flow|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
10835641|NCT00178126|OG000|Outcome|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
10835642|NCT00178126|OG001|Outcome|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
10835643|NCT00178126|EG000|Reported Event|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
10835644|NCT00178126|EG001|Reported Event|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
10835645|NCT00178178|BG000|Baseline|Drug: Intraarticularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835646|NCT00178178|BG001|Baseline|Drug: Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835647|NCT00178178|BG002|Baseline|Drug: Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835648|NCT00178178|BG003|Baseline|Placebo Comparator|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835649|NCT00178178|BG004|Baseline|Total|Total of all reporting groups
10835650|NCT00178178|FG000|Participant Flow|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835651|NCT00178178|FG001|Participant Flow|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835652|NCT00178178|FG002|Participant Flow|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835653|NCT00178178|FG003|Participant Flow|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835654|NCT00178178|OG000|Outcome|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835655|NCT00178178|OG001|Outcome|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835656|NCT00178178|OG002|Outcome|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835657|NCT00178178|OG003|Outcome|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835658|NCT00178178|EG000|Reported Event|Intraartciularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835659|NCT00178178|EG001|Reported Event|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835660|NCT00178178|EG002|Reported Event|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835661|NCT00178178|EG003|Reported Event|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
10835662|NCT00178191|BG000|Baseline|200 Units Botox|200 units Botulinum-A toxin
10835663|NCT00178191|BG001|Baseline|300 Units Botox|300 units Botulinum-A toxin
10835664|NCT00178191|BG002|Baseline|Placebo|Placebo
10835665|NCT00178191|BG003|Baseline|Total|Total of all reporting groups
10835666|NCT00178191|FG000|Participant Flow|200 Units Botox|200 units Botulinum-A toxin
10835667|NCT00178191|FG001|Participant Flow|300 Units Botox|300 units Botulinum-A toxin
10835668|NCT00178191|FG002|Participant Flow|Placebo|Placebo
10835669|NCT00178191|OG000|Outcome|200 Units Botox|200 units Botulinum-A toxin
10835670|NCT00178191|OG001|Outcome|300 Units Botox|300 units Botulinum-A toxin
10835671|NCT00178191|OG002|Outcome|Placebo|Placebo
10835672|NCT00178191|EG000|Reported Event|200 Units Botox|200 units Botulinum-A toxin
10835673|NCT00178191|EG001|Reported Event|300 Units Botox|300 units Botulinum-A toxin
10835674|NCT00178191|EG002|Reported Event|Placebo|Placebo
10835675|NCT00178256|BG000|Baseline|Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
10835676|NCT00178256|FG000|Participant Flow|First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
10835677|NCT00178256|FG001|Participant Flow|Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
10835678|NCT00178256|FG002|Participant Flow|Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT|"A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
10835679|NCT00178256|FG003|Participant Flow|Phase II Group (20mg/m2 Taxol)|"Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.~If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1."
10835680|NCT00178256|OG000|Outcome|1st Dose Cohort 15mg/m2 Taxol Plus RT|"15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
10842870|NCT00249873|FG001|Participant Flow|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
10835681|NCT00178256|OG001|Outcome|2nd Dose cohort20 mg/m2 Taxol Plus Daily RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
10835682|NCT00178256|OG002|Outcome|3rd Dose Cohort --25mg/m2 Taxol Plus RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
10835683|NCT00178256|OG000|Outcome|All Pts Enrolled Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
10835684|NCT00178256|EG000|Reported Event|All Subjects Enrolled|
10835685|NCT00178399|BG000|Baseline|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy
10835686|NCT00178399|FG000|Participant Flow|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy
10835687|NCT00178399|OG000|Outcome|Stereotactic Body Radiation Therapy|Subjects received Stereotactic Body Radiation Therapy
10835688|NCT00178399|OG000|Outcome|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy
10835689|NCT00178399|EG000|Reported Event|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy
10835690|NCT00178464|BG000|Baseline|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
10835691|NCT00178464|FG000|Participant Flow|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
10835692|NCT00178464|OG000|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
10835693|NCT00178464|EG000|Reported Event|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
10835694|NCT00178503|BG000|Baseline|MPH Trial|24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase
10835695|NCT00178503|FG000|Participant Flow|MPH Trial|24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.
10835696|NCT00178503|OG000|Outcome|MPH Trial-Placebo Week|All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
10835697|NCT00178503|OG001|Outcome|MPH Trial: Low Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835698|NCT00178503|OG002|Outcome|MPH Trial: Med Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835699|NCT00178503|OG003|Outcome|MPH Trial: High Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
10835700|NCT00178503|OG000|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
10835701|NCT00178503|OG001|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835702|NCT00178503|OG002|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835703|NCT00178503|OG003|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835704|NCT00178503|OG001|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835705|NCT00178503|EG000|Reported Event|MPH Trial-Placebo|Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase
10835706|NCT00178503|EG001|Reported Event|MPH Trial: Low Dose|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835707|NCT00178503|EG002|Reported Event|MPH Trial: Med Dose|Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835708|NCT00178503|EG003|Reported Event|MPH Trial: High Dose|Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
10835709|NCT00178633|BG000|Baseline|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
10835710|NCT00178633|FG000|Participant Flow|Bariatric Surgery|
10835711|NCT00178633|OG000|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
10835712|NCT00178633|EG000|Reported Event|Bariatric Surgery, Follow up at 9 Months|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
11219770|NCT02329730|BG001|Baseline|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10835713|NCT00178633|EG001|Reported Event|Bariatric Surgery, Follow up at 2 Years|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
10835714|NCT00178646|BG000|Baseline|Low Volume, High Dose|"Botox, 150 units prepared as 100 units/ml~Botox: Botox 75-150 units, single treatment only"
10835715|NCT00178646|BG001|Baseline|High Volume, High Dose|"Botox 150 units, prepared as 50 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835716|NCT00178646|BG002|Baseline|Low Volume, Low Dose|"Botox 75 units, prepared as 25 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835717|NCT00178646|BG003|Baseline|Total|Total of all reporting groups
10835718|NCT00178646|FG000|Participant Flow|Low Volume, High Dose|"Botox, 150 units prepared as 100 units/ml~Botox: Botox 75-150 units, single treatment only"
10835719|NCT00178646|FG001|Participant Flow|High Volume, High Dose|"Botox 150 units, prepared as 50 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835720|NCT00178646|FG002|Participant Flow|High Volume, Low Dose|"Botox 75 units, prepared as 25 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835721|NCT00178646|OG000|Outcome|Low Volume, High Dose|"Botox, 150 units prepared as 100 units/ml~Botox: Botox 75-150 units, single treatment only"
10835722|NCT00178646|OG001|Outcome|High Volume, High Dose|"Botox 150 units, prepared as 50 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835723|NCT00178646|OG002|Outcome|High Volume, Low Dose|"Botox 75 units, prepared as 25 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835724|NCT00178646|OG000|Outcome|Low Volume, High Dose|"Low volume, High Dose:~Botox, 150 units prepared as 100 units/ml~Botox: Botox 75-150 units, single treatment only"
10835725|NCT00178646|OG001|Outcome|High Volume, High Dose|"High volume, High Dose:~Botox 150 units, prepared as 50 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835726|NCT00178646|OG002|Outcome|High Volume, Low Dose|"HIgh Volume, Low Dose:~Botox 75 units, prepared as 25 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835727|NCT00178646|EG000|Reported Event|Low Volume, High Dose|"Botox, 150 units prepared as 100 units/ml~Botox: Botox 75-150 units, single treatment only"
10835728|NCT00178646|EG001|Reported Event|High Volume, High Dose|"Botox 150 units, prepared as 50 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835729|NCT00178646|EG002|Reported Event|Low Volume, Low Dose|"Botox 75 units, prepared as 25 units/ml.~Botox: Botox 75-150 units, single treatment only"
10835730|NCT00178685|BG000|Baseline|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
10835731|NCT00178685|BG001|Baseline|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
10835732|NCT00178685|BG002|Baseline|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
10835733|NCT00178685|BG003|Baseline|Total|Total of all reporting groups
10835734|NCT00178685|FG000|Participant Flow|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
10835735|NCT00178685|FG001|Participant Flow|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
10835736|NCT00178685|FG002|Participant Flow|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
10835737|NCT00178685|OG000|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
10842871|NCT00249873|OG000|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
10842872|NCT00249873|OG001|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
10835738|NCT00178685|OG001|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
10835739|NCT00178685|OG002|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
10835740|NCT00178685|EG000|Reported Event|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
10835741|NCT00178685|EG001|Reported Event|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
10835742|NCT00178685|EG002|Reported Event|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
10835743|NCT00178711|BG000|Baseline|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
10835744|NCT00178711|BG001|Baseline|Control|Treated at normothermia
10835745|NCT00178711|BG002|Baseline|Total|Total of all reporting groups
10835746|NCT00178711|FG000|Participant Flow|Hypothermia|"There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure <110 mm Hg, diastolic blood pressure <60 mm Hg, sustained heart rate >120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury.~Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score >4 for organs other than brain4, systolic blood pressure <110 mm Hg or diastolic blood pressure <60 mm Hg, persistent hypoxia, (oxygen saturation < 94%), or positive pregnancy test."
10835747|NCT00178711|FG001|Participant Flow|Control|45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
10835748|NCT00178711|OG000|Outcome|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
10835749|NCT00178711|OG001|Outcome|Control|treated at normothermia
10835750|NCT00178711|EG000|Reported Event|Randomized to Hypothermia and Hypothermia Maintained|Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria
10835751|NCT00178711|EG001|Reported Event|Randomized to Normothermia and Normothermia Maintained|Induction and maintenance of normothermia and not excluded by second set of exclusion criteria
10835752|NCT00178711|EG002|Reported Event|Randomized to Hypothermia and Then Excluded|Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria
10835753|NCT00178711|EG003|Reported Event|Randomized to Normothermia Then Excluded|Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
10835754|NCT00178841|BG000|Baseline|Single Arm Study|All enrolled patients received rosiglitazone in addition to oral bexarotene
10835755|NCT00178841|FG000|Participant Flow|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
10835756|NCT00178841|OG000|Outcome|Rosiglitazone and Bexarotene|All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
10835757|NCT00178841|OG000|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
10835758|NCT00178841|EG000|Reported Event|Rosiglitazone and Bexarotene|All enrolled patients received rosiglitazone in addition to oral bexarotene.
10835759|NCT00178919|BG000|Baseline|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
10835760|NCT00178919|BG001|Baseline|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
10835761|NCT00178919|BG002|Baseline|Total|Total of all reporting groups
10835762|NCT00178919|FG000|Participant Flow|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
10835763|NCT00178919|FG001|Participant Flow|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
10835764|NCT00178919|OG000|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
10835765|NCT00178919|OG001|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
10835766|NCT00178919|EG000|Reported Event|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
10835767|NCT00178919|EG001|Reported Event|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
10835768|NCT00179010|BG000|Baseline|Adenosine Mono Phosphate (AMP) First|"Intrarterial infusion of AMP~Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)"
10835769|NCT00179010|BG001|Baseline|Adenosine First|"Intrarterial infusion of adenosine~Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each"
10835770|NCT00179010|BG002|Baseline|Total|Total of all reporting groups
10835771|NCT00179010|FG000|Participant Flow|Adenosine First Then AMP|"Intrarterial infusion of adenosine first~Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each~Subjects in this group were assigned to received intrarterial infusions of adenosine and then crossed to the other arm (AMP) after at least 1 month."
10835772|NCT00179010|FG001|Participant Flow|Adenosine Mono Phosphate (AMP) First Then Adenosine|"Intrarterial infusion of AMP first~Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)~Subjects intros group were assigned to received intrarterial infusions of AMP and then crossed to the other arm (adenosine), at least 1 month after."
10835773|NCT00179010|OG000|Outcome|Adenosine|"Intrarterial infusion of adenosine~Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each"
10835774|NCT00179010|OG001|Outcome|Adenosine Mono Phosphate (AMP)|Intra-arterial infusion of AMP
10835775|NCT00179010|OG001|Outcome|Adenosine Mono Phosphate (AMP)|"Intrarterial infusion of AMP~Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)"
10835776|NCT00179010|EG000|Reported Event|Adenosine|"Intrarterial infusion of adenosine~Adenosine: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each"
10835777|NCT00179010|EG001|Reported Event|Adenosine Mono Phosphate (AMP)|"Intrarterial infusion of AMP~Adenosine Mono Phosphate (AMP): Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)"
10835778|NCT00179309|BG000|Baseline|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
10835779|NCT00179309|BG001|Baseline|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
10835780|NCT00179309|BG002|Baseline|Total|Total of all reporting groups
10835781|NCT00179309|FG000|Participant Flow|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V: given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
10835782|NCT00179309|FG001|Participant Flow|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
10842873|NCT00249873|EG000|Reported Event|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
10842874|NCT00249873|EG001|Reported Event|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
10835783|NCT00179309|OG000|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
10835784|NCT00179309|OG001|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
10835785|NCT00179309|EG000|Reported Event|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
10835786|NCT00179309|EG001|Reported Event|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
10835787|NCT00179413|BG000|Baseline|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
10835788|NCT00179413|BG001|Baseline|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
10835789|NCT00179413|BG002|Baseline|Total|Total of all reporting groups
10835790|NCT00179413|FG000|Participant Flow|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
10835791|NCT00179413|FG001|Participant Flow|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
10835792|NCT00179413|OG000|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
10835793|NCT00179413|OG001|Outcome|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
10835794|NCT00179413|EG000|Reported Event|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
10835795|NCT00179413|EG001|Reported Event|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
10835796|NCT00179478|BG000|Baseline|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835797|NCT00179478|BG001|Baseline|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835798|NCT00179478|BG002|Baseline|Total|Total of all reporting groups
10835799|NCT00179478|FG000|Participant Flow|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835800|NCT00179478|FG001|Participant Flow|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835801|NCT00179478|OG000|Outcome|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835802|NCT00179478|OG001|Outcome|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
10835803|NCT00179478|EG000|Reported Event|All Study Participants|All patients in the study were receiving the same FDA approved treatment, interferon beta 1a IM once weekly (AVONEX), which they received commercially through their insurance coverage. No AEs were collected and any serious AEs that occurred, would have been reported to the manufacturer (Biogen). We collected information on all cause mortality on the cohort of 155 patients who continued in the 10 year extension study. This was done as an additional outcome measure since we anticipated that there may be deaths due to the primary disease (MS) over a period of observation as long as 10 years.
10835804|NCT00179517|BG000|Baseline|Depotestosterone Plus Anastrozole (T-A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
10835805|NCT00179517|BG001|Baseline|Depotestosterone Plus Placebo (T-P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
10835806|NCT00179517|BG002|Baseline|Total|Total of all reporting groups
10835807|NCT00179517|FG000|Participant Flow|Depotestosterone Plus Anastrozole (T-A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
10835808|NCT00179517|FG001|Participant Flow|Depotestosterone Plus Placebo (T-P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
10835809|NCT00179517|OG000|Outcome|Depotestosterone Plus Anastrozole (T-A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
10835810|NCT00179517|OG001|Outcome|Depotestosterone Plus Placebo (T-P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
10835811|NCT00179517|EG000|Reported Event|Depotestosterone Plus Anastrozole (T-A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
10835812|NCT00179517|EG001|Reported Event|Depotestosterone Plus Placebo (T-P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
10835813|NCT00179621|BG000|Baseline|Placebo|Placebo matching to active study arms.
10835814|NCT00179621|BG001|Baseline|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
10835815|NCT00179621|BG002|Baseline|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
10835816|NCT00179621|BG003|Baseline|Total|Total of all reporting groups
10835817|NCT00179621|FG000|Participant Flow|Placebo|Placebo matching to active study arms.
10835818|NCT00179621|FG001|Participant Flow|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
10835819|NCT00179621|FG002|Participant Flow|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
10835820|NCT00179621|FG003|Participant Flow|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
10835821|NCT00179621|OG000|Outcome|Placebo|Placebo matching to active study arms.
10835822|NCT00179621|OG001|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
10835823|NCT00179621|OG002|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
10835824|NCT00179621|EG000|Reported Event|Placebo|Placebo matching to active study arms.
10835825|NCT00179621|EG001|Reported Event|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
10835826|NCT00179621|EG002|Reported Event|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
10835827|NCT00179621|EG003|Reported Event|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
10835828|NCT00179647|BG000|Baseline|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
10835829|NCT00179647|FG000|Participant Flow|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
10835830|NCT00179647|OG000|Outcome|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
10843314|NCT00253643|FG000|Participant Flow|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
10835831|NCT00179647|EG000|Reported Event|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
10835832|NCT00179660|BG000|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835833|NCT00179660|FG000|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835834|NCT00179660|OG000|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835835|NCT00179660|EG000|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835836|NCT00179673|BG000|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835837|NCT00179673|FG000|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835838|NCT00179673|OG000|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835839|NCT00179673|EG000|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
10835840|NCT00179777|BG000|Baseline|Nonhydrolysed Infant Formula|A conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate.
10835841|NCT00179777|BG001|Baseline|Hydrolysed Infant Formula|Hydrolysed Infant Formula missing intact cows milk proteins
10835842|NCT00179777|BG002|Baseline|Total|Total of all reporting groups
10835843|NCT00179777|FG000|Participant Flow|Hydrolysed Infant Formula|"Hydrolysed infant formula~hydrolysed infant formula: hydrolysed infant formula"
10835844|NCT00179777|FG001|Participant Flow|Nonhydrolysed Infant Formula|"Nonhydrolysed infant formula~nonhydrolysed infant formula: nonhydrolysed infant formula"
10835845|NCT00179777|OG000|Outcome|Nonhydrolysed Infant Formula|Number of participants diagnosed with type 1 diabetes
10835846|NCT00179777|OG001|Outcome|Hydrolysed Infant Formula|Number of participants diagnosed with type 1 diabetes
10835847|NCT00179777|OG000|Outcome|Nonhydrolysed Infant Formula|Diabetes associated autoantibodies (ICA, IAA, GADA, IA-2A) in the nonhydrolysed infant formula
10835848|NCT00179777|OG001|Outcome|Hydrolysed Infant Formula|Diabetes associated autoantibodies (ICA, IAA, GADA, IA-2A) in the hydrolysed infant formula
10835849|NCT00179777|EG000|Reported Event|Nonhydrolysed Infant Formula|Reported Adverse Events during the Follow-up in the Nonhydrolysed Infant Formula Group
10835850|NCT00179777|EG001|Reported Event|Hydrolysed Infant Formula|Reported Adverse Events during the Follow-up in the Hydrolysed Infant Formula Group
10835851|NCT00179959|BG000|Baseline|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
10835852|NCT00179959|BG001|Baseline|Placebo|Intranasal petrolatum ointment treatment and plain water baths
10835853|NCT00179959|BG002|Baseline|Total|Total of all reporting groups
10835854|NCT00179959|FG000|Participant Flow|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
10835855|NCT00179959|FG001|Participant Flow|Placebo|Intranasal petrolatum ointment treatment and plain water baths
10835856|NCT00179959|OG000|Outcome|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
10835857|NCT00179959|OG001|Outcome|Placebo|Intranasal petrolatum ointment treatment and plain water baths
10835858|NCT00179959|EG000|Reported Event|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
10835859|NCT00179959|EG001|Reported Event|Placebo|Intranasal petrolatum ointment treatment and plain water baths
10835860|NCT00179998|BG000|Baseline|Nebulized rhDNAse Then Placebo|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months then 3 ml diluent placebo delivered by nebulization given daily for 6 months"
10835861|NCT00179998|BG001|Baseline|Placebo Then Nebulized rhDNAse|"once daily nebulized vehicle~Recombinant Human DNase (Pulmozyme): Comparison of 3 ml diluent placebo delivered by nebulization given daily for 6 months then 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months"
10835862|NCT00179998|BG002|Baseline|Total|Total of all reporting groups
10835863|NCT00179998|FG000|Participant Flow|1 - rhDNase Then Placebo|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months"
10835864|NCT00179998|FG001|Participant Flow|2 - Placebo Then rhDNase|"once daily nebulized vehicle~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months"
10835865|NCT00179998|OG000|Outcome|Nebulized rhDNAse|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months"
10835866|NCT00179998|OG001|Outcome|Nebulized Saline|once daily nebulized vehicle
10835867|NCT00179998|OG000|Outcome|Nebulized rhDNAse Then Placebo|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months"
10835868|NCT00179998|OG001|Outcome|Placebo (Nebulized Saline) Then rhDNAse|Once daily 3 ml diluent delivered by nebulization given daily for 6 months followed by 2.5 mg rhDNAse in 3 ml diluent delivered by nebulization given daily for 6 months
10835869|NCT00179998|OG000|Outcome|Nebulized rhDNAse Then Placebo|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent. IPFTs and CV-HRCT will be performed at that time. These subjects will then receive the placebo (Normal saline) delivered by nebulization given daily for 6 months. IPFT and CV-HRCTs will be performed again at 1 year."
10835870|NCT00179998|OG001|Outcome|Placebo (Nebulized Saline) Then rhDNAse|Those placed in the placebo arm with receive nebulized normal saline daily for 6 months. Following evaluation by IPFT and CV-HRCT, these subjects will receive the study drug daily for 6 months by the same delivery method. IPFT and CT-HRCTs will be performed again at 1 year.
10835871|NCT00179998|EG000|Reported Event|Nebulized rhDNAse Then Placebo(Nebulized Saline)|"once daily nebulized rhDNAse~Recombinant Human DNase (Pulmozyme): Comparison of 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months~Data is unavailable for the second period. The PI has retired and is no longer associated with the institution."
10835872|NCT00179998|EG001|Reported Event|Placebo (Nebulized Saline) Then rhDNAse|"Once daily nebulized saline daily for 6 months, followed by Recombinant Human DNase (Pulmozyme) in 3 ml diluent daily for 6 months~Data is unavailable for the second period. The PI has retired and is no longer associated with the institution."
10835873|NCT00180271|BG000|Baseline|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
10835874|NCT00180271|BG001|Baseline|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
10835875|NCT00180271|BG002|Baseline|Total|Total of all reporting groups
10835876|NCT00180271|FG000|Participant Flow|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
10835877|NCT00180271|FG001|Participant Flow|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
10835878|NCT00180271|OG000|Outcome|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
10835879|NCT00180271|OG001|Outcome|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
10835880|NCT00180271|OG000|Outcome|CRT-D|"CRT-D: Cardiac resynchronization therapy with defibrillation.~Cardiac resynchronization therapy with defibrillation: Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation"
10835881|NCT00180271|OG001|Outcome|ICD: Implantable Cardioverter Defibrillator|"ICD: Implantable cardioverter defibrillator~Implantable Cardioverter Defibrillator (ICD): Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator"
10835882|NCT00180271|EG000|Reported Event|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
10835883|NCT00180271|EG001|Reported Event|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
10835884|NCT00180297|BG000|Baseline|Mid Septal Site Location|"RV lead is placed at mid septum.~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835885|NCT00180297|BG001|Baseline|Apical Site Location|"RV lead is placed in apical position~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835886|NCT00180297|BG002|Baseline|Total|Total of all reporting groups
10835887|NCT00180297|FG000|Participant Flow|Mid Septal Site Location|"RV lead is placed at mid septum.~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835888|NCT00180297|FG001|Participant Flow|Apical Site Location|"RV lead is placed in apical position~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835889|NCT00180297|OG000|Outcome|Mid Septal Site Location|"RV lead is placed at mid septum.~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835890|NCT00180297|OG001|Outcome|Apical Site Location|"RV lead is placed in apical position~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835891|NCT00180297|EG000|Reported Event|Mid Septal Site Location|"RV lead is placed at mid septum.~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835892|NCT00180297|EG001|Reported Event|Apical Site Location|"RV lead is placed in apical position~Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle."
10835893|NCT00180323|BG000|Baseline|Group 1|
10835894|NCT00180323|FG000|Participant Flow|Group 1|
10835895|NCT00180323|OG000|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
10835896|NCT00180323|OG000|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
10835897|NCT00180323|OG000|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
10835898|NCT00180323|EG000|Reported Event|Group 1|
10835899|NCT00180479|BG000|Baseline|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
10835900|NCT00180479|BG001|Baseline|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
10835901|NCT00180479|BG002|Baseline|Total|Total of all reporting groups
10835902|NCT00180479|FG000|Participant Flow|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
10835903|NCT00180479|FG001|Participant Flow|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
10835904|NCT00180479|OG000|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
10835905|NCT00180479|OG001|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
10835906|NCT00180479|EG000|Reported Event|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
10835907|NCT00180479|EG001|Reported Event|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
10835908|NCT00180661|BG000|Baseline|Non-severe Asthma|Patients with Non-severe asthma
10835909|NCT00180661|BG001|Baseline|Severe Asthma|Patients with severe asthma
10835910|NCT00180661|BG002|Baseline|Total|Total of all reporting groups
10835911|NCT00180661|FG000|Participant Flow|Non-severe Asthma|Patients with Non-severe asthma
10835912|NCT00180661|FG001|Participant Flow|Severe Asthma|Patients with severe asthma
10835913|NCT00180661|OG000|Outcome|Non-severe Asthma|Patients with Non-severe asthma
10835914|NCT00180661|OG001|Outcome|Severe Asthma|Patients with severe asthma
10835915|NCT00180661|EG000|Reported Event|Non-severe Asthma|Patients with Non-severe asthma
10835916|NCT00180661|EG001|Reported Event|Severe Asthma|Patients with severe asthma
10835917|NCT00180674|BG000|Baseline|Warfarin Anticoagulation|Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (Phase 2, Treatment Period).
10835918|NCT00180674|FG000|Participant Flow|Warfarin Anticoagulation|Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (Phase 2, Treatment Period).
10835919|NCT00180674|OG000|Outcome|Observation Period|Phase 1, Observation Period Observation period began at Week 0 and was completed at Week 8.
10835920|NCT00180674|OG001|Outcome|Warfarin Anticoagulation|Phase 2, Treatment Period Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
10835921|NCT00180674|OG000|Outcome|Observation Period|Phase 1, Observation Period Phase 1 of the study consisted of 8 weeks of observation, which commenced following a baseline visit at week 0.
10835922|NCT00180674|OG001|Outcome|Warfarin Treatment Period|"Phase 2, Treatment Period:~Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period)."
10835923|NCT00180674|EG000|Reported Event|Observation Period (Phase 1)|Phase 1, Observation Period Phase 1 of the study consisted of 8 weeks of observation, which commenced following a baseline visit at week 0.
10835924|NCT00180674|EG001|Reported Event|Warfarin Anticoagulation (Phase 2|"Phase 2, Treatment Period Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).~A single adverse event was noted in one subject during the anticoagulation period. This was classed as minor in severity and related to an episode of minor haemorrhage secondary to an episode of gingivitis, which resolved following antibiotics and did not require blood transfusion, but did require cessation of the anticoagulation for a short period of 2 days. This patient was not included in the analysis. No other subjects required cessation of treatment during the anticoagulation period."
10835925|NCT00180687|BG000|Baseline|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
10835926|NCT00180687|BG001|Baseline|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
10835927|NCT00180687|BG002|Baseline|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
10835928|NCT00180687|BG003|Baseline|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
10835929|NCT00180687|BG004|Baseline|Total|Total of all reporting groups
10835930|NCT00180687|FG000|Participant Flow|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
10835931|NCT00180687|FG001|Participant Flow|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
10835932|NCT00180687|FG002|Participant Flow|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
10835933|NCT00180687|FG003|Participant Flow|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
10835934|NCT00180687|OG000|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
10835935|NCT00180687|OG001|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
10835936|NCT00180687|OG002|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
10835937|NCT00180687|OG003|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
10835938|NCT00180687|EG000|Reported Event|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
10835939|NCT00180687|EG001|Reported Event|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
10835940|NCT00180687|EG002|Reported Event|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
10835941|NCT00180687|EG003|Reported Event|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
10835942|NCT00180713|BG000|Baseline|Arm 1: Control|"Placebo tablet once daily~Placebo: Placebo tablet once daily."
10835943|NCT00180713|BG001|Baseline|Arm 2: Experimental|"Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.~Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months"
10835944|NCT00180713|BG002|Baseline|Total|Total of all reporting groups
10835945|NCT00180713|FG000|Participant Flow|Arm 1: Control|"Placebo tablet once daily~Placebo: Placebo tablet once daily."
10835946|NCT00180713|FG001|Participant Flow|Arm 2: Experimental|"Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.~Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months"
10835947|NCT00180713|OG000|Outcome|Arm 1: Control|"Placebo tablet once daily~Placebo: Placebo tablet once daily."
10835948|NCT00180713|OG001|Outcome|Arm 2: Experimental|"Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.~Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months"
10835949|NCT00180713|EG000|Reported Event|Arm 1: Control|"Placebo tablet once daily~Placebo: Placebo tablet once daily."
10835950|NCT00180713|EG001|Reported Event|Arm 2: Experimental|"Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.~Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months"
10835951|NCT00181155|BG000|Baseline|Intravenous Allopurinol|We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31-Phosphorus (31P) magnetic resonance spectroscopy.
10835952|NCT00181155|FG000|Participant Flow|Allopurinol|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
10835953|NCT00181155|FG001|Participant Flow|Placebo|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
10835954|NCT00181155|OG000|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
10835955|NCT00181155|OG000|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc 5% dextrose. Post MRS data acquired on each subject.
10835956|NCT00181155|OG000|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc of 5% dextrose. Post infusion MRS data acquired on each subject.
10835957|NCT00181155|EG000|Reported Event|Arm 1 - Intravenous Allopurinol|Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
10835958|NCT00181155|EG001|Reported Event|Arm 2 - Placebo|Each participant received pre and post MRS images following infusion of 50 cc of 5% Dextrose (equivalent volume to active treatment arm).
10835959|NCT00181168|BG000|Baseline|Euthyroid Group|"Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.~Subjects received rhTSH to prepare for radioiodine therapy"
10835960|NCT00181168|BG001|Baseline|Hypothyroid Group|"Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.~Thyroid hormone treatment was withheld before radioiodine therapy."
10835961|NCT00181168|BG002|Baseline|Total|Total of all reporting groups
10835962|NCT00181168|FG000|Participant Flow|Euthyroid Group|Subjects received rhTSH to prepare for radioiodine therapy
10835963|NCT00181168|FG001|Participant Flow|Hypothyroid Group|Thyroid hormone treatment was withheld before radioiodine therapy.
10835964|NCT00181168|OG000|Outcome|Euthyroid Group|Subjects received rhTSH to prepare for radioiodine therapy.
10835965|NCT00181168|OG001|Outcome|Hypothyroid Group|Thyroid hormone treatment was withheld before radioiodine therapy.
10835966|NCT00181168|EG000|Reported Event|Euthyroid Group|"Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.~Subjects received rhTSH to prepare for radioiodine therapy"
10835967|NCT00181168|EG001|Reported Event|Hypothyroid Group|"Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.~Thyroid hormone treatment was withheld before radioiodine therapy."
10835968|NCT00181207|BG000|Baseline|Sham|received sham version of VEST
10835969|NCT00181207|BG001|Baseline|Active|received functional version of VEST
10835970|NCT00181207|BG002|Baseline|Total|Total of all reporting groups
10835971|NCT00181207|FG000|Participant Flow|Sham|Placebo Comparator: Sham Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating
10835972|NCT00181207|FG001|Participant Flow|Active|Experimental: Active Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks
10835973|NCT00181207|OG000|Outcome|Sham|received sham version of VEST
10835974|NCT00181207|OG001|Outcome|Active|received functional version of VEST
10835975|NCT00181207|EG000|Reported Event|Sham|received sham version of VEST
10835976|NCT00181207|EG001|Reported Event|Active|received functional version of VEST
10835977|NCT00181285|BG000|Baseline|Sham High Frequency Chest Wall Oscillation|"Sham high frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835978|NCT00181285|BG001|Baseline|Active High Frequency Chest Wall Oscillation|"High frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835979|NCT00181285|BG002|Baseline|Total|Total of all reporting groups
10835980|NCT00181285|FG000|Participant Flow|Sham High Frequency Chest Wall Oscillation|"Sham high frequency chest wall oscillation.~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835981|NCT00181285|FG001|Participant Flow|Active High Frequency Chest Wall Oscillation|"High frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835982|NCT00181285|OG000|Outcome|Sham High Frequency Chest Wall Oscillation|"Sham high frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835983|NCT00181285|OG001|Outcome|Active High Frequency Chest Wall Oscillation|"Active high frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835984|NCT00181285|EG000|Reported Event|Sham High Frequency Chest Wall Oscillation|"Sham high frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835985|NCT00181285|EG001|Reported Event|Active High Frequency Chest Wall Oscillation|"Active high frequency chest wall oscillation~High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax"
10835986|NCT00181363|BG000|Baseline|Group 1|Mamma board
10835987|NCT00181363|FG000|Participant Flow|Mamma Board|Mamma board used during radiotherapy
10835988|NCT00181363|OG000|Outcome|Prone|Prone position
10835989|NCT00181363|OG001|Outcome|Supine|Supine position
10835990|NCT00181363|OG000|Outcome|Prone|Prone Position
10835991|NCT00181363|OG001|Outcome|Supine|Supine Position
10835992|NCT00181363|EG000|Reported Event|Group 1|Mamma board
10835993|NCT00181610|BG000|Baseline|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
10835994|NCT00181610|BG001|Baseline|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
10835995|NCT00181610|BG002|Baseline|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
10835996|NCT00181610|BG003|Baseline|Total|Total of all reporting groups
10835997|NCT00181610|FG000|Participant Flow|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
10835998|NCT00181610|FG001|Participant Flow|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
10835999|NCT00181610|FG002|Participant Flow|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
10836000|NCT00181610|OG000|Outcome|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
10836001|NCT00181610|OG001|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
10836002|NCT00181610|OG002|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours"
10836003|NCT00181610|OG002|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
10836004|NCT00181610|EG000|Reported Event|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
10836005|NCT00181610|EG001|Reported Event|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
10836006|NCT00181610|EG002|Reported Event|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
10836007|NCT00181623|BG000|Baseline|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
10836008|NCT00181623|FG000|Participant Flow|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
10836009|NCT00181623|OG000|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
10836010|NCT00181623|OG000|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
10836011|NCT00181623|EG000|Reported Event|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
10836012|NCT00181714|BG000|Baseline|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
10836013|NCT00181714|FG000|Participant Flow|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
10836014|NCT00181714|OG000|Outcome|OROS-Methylphenidate|
10836015|NCT00181714|EG000|Reported Event|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
10836016|NCT00181766|BG000|Baseline|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
10836017|NCT00181766|FG000|Participant Flow|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
10836018|NCT00181766|OG000|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
10836019|NCT00181766|EG000|Reported Event|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
10836020|NCT00181844|BG000|Baseline|Lamotrigine|
10836021|NCT00181844|FG000|Participant Flow|Lamotrigine|
10836022|NCT00181844|OG000|Outcome|Lamotrigine|
10836023|NCT00181844|EG000|Reported Event|Lamotrigine|
10842875|NCT00250276|BG000|Baseline|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842876|NCT00250276|BG001|Baseline|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842877|NCT00250276|BG002|Baseline|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842878|NCT00250276|BG003|Baseline|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842879|NCT00250276|BG004|Baseline|Total|Total of all reporting groups
10842880|NCT00250276|FG000|Participant Flow|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842881|NCT00250276|FG001|Participant Flow|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842882|NCT00250276|FG002|Participant Flow|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842883|NCT00250276|FG003|Participant Flow|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842884|NCT00250276|OG000|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842885|NCT00250276|OG001|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842886|NCT00250276|OG002|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842887|NCT00250276|OG003|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
10842888|NCT00250276|OG004|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842889|NCT00250276|OG003|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10836024|NCT00181883|BG000|Baseline|Quetiapine|
10836025|NCT00181883|FG000|Participant Flow|Quetiapine|
10836026|NCT00181883|OG000|Outcome|Quetiapine|
10836027|NCT00181883|EG000|Reported Event|Quetiapine|
10836028|NCT00181961|BG000|Baseline|Maca Root 1500mg|"Patients receiving 1500mg of maca root~Maca Root"
10836029|NCT00181961|BG001|Baseline|Maca Root 3000mg|"Patients receiving 3000mg of maca root~Maca Root"
10836030|NCT00181961|BG002|Baseline|Total|Total of all reporting groups
10836031|NCT00181961|FG000|Participant Flow|Maca Root 1500mg|"Patients receiving 1500mg of maca root~Maca Root"
10836032|NCT00181961|FG001|Participant Flow|Maca Root 3000mg|"Patients receiving 3000mg of maca root~Maca Root"
10836033|NCT00181961|OG000|Outcome|Maca Root 1500mg|"Patients receiving 1500mg of maca root~Maca Root"
10836034|NCT00181961|OG001|Outcome|Maca Root 3000mg|"Patients receiving 3000mg of maca root~Maca Root"
10836035|NCT00181961|EG000|Reported Event|Maca Root 1500mg|"Patients receiving 1500mg of maca root~Maca Root"
10836036|NCT00181961|EG001|Reported Event|Maca Root 3000mg|"Patients receiving 3000mg of maca root~Maca Root"
10836037|NCT00182000|BG000|Baseline|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
10836038|NCT00182000|BG001|Baseline|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
10836039|NCT00182000|BG002|Baseline|Total|Total of all reporting groups
10836040|NCT00182000|FG000|Participant Flow|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
10836041|NCT00182000|FG001|Participant Flow|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
10836042|NCT00182000|OG000|Outcome|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
10836043|NCT00182000|OG001|Outcome|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
10836044|NCT00182000|EG000|Reported Event|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
10836045|NCT00182000|EG001|Reported Event|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
10836046|NCT00182078|BG000|Baseline|Placebo|Placebo group who received no study medication.
10836047|NCT00182078|BG001|Baseline|Sertraline|Sertraline group received study medication every day for 12 weeks.
10836048|NCT00182078|BG002|Baseline|Total|Total of all reporting groups
10836049|NCT00182078|FG000|Participant Flow|Placebo - Received Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
10836050|NCT00182078|FG001|Participant Flow|Sertraline - Received Study Medication|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
10836051|NCT00182078|OG000|Outcome|Placebo|Placebo group who received no study medication.
10836052|NCT00182078|OG001|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
10836053|NCT00182078|EG000|Reported Event|Placebo|Placebo group who received no study medication.
10836054|NCT00182078|EG001|Reported Event|Sertraline|Sertraline group received study medication every day for 12 weeks.
10836055|NCT00182091|BG000|Baseline|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
10836056|NCT00182091|BG001|Baseline|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
10836057|NCT00182091|BG002|Baseline|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
10836058|NCT00182091|BG003|Baseline|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
10836059|NCT00182091|BG004|Baseline|Total|Total of all reporting groups
10836060|NCT00182091|FG000|Participant Flow|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
10836061|NCT00182091|FG001|Participant Flow|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
10836062|NCT00182091|FG002|Participant Flow|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
10836063|NCT00182091|FG003|Participant Flow|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
10836064|NCT00182091|OG000|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
10836065|NCT00182091|OG001|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
10836066|NCT00182091|EG000|Reported Event|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
10836067|NCT00182091|EG001|Reported Event|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
10836068|NCT00182091|EG002|Reported Event|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
10836069|NCT00182091|EG003|Reported Event|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
10836070|NCT00182325|BG000|Baseline|Personalized Information and Internet Access|Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
11328576|NCT03429556|EG003|Reported Event|Botulinum Neurotoxin Serotype E Dose 3|Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
10836071|NCT00182325|BG001|Baseline|General Resource Internet Access|Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
10836072|NCT00182325|BG002|Baseline|Total|Total of all reporting groups
10836073|NCT00182325|FG000|Participant Flow|Personalized Information and Internet Access|Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
10836074|NCT00182325|FG001|Participant Flow|General Resource Internet Access|Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
10836075|NCT00182325|OG000|Outcome|Personalized Information and Internet Access|Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
10836076|NCT00182325|OG001|Outcome|General Resource Internet Access|Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
10836077|NCT00182325|EG000|Reported Event|Personalized Information and Internet Access|Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
10836078|NCT00182325|EG001|Reported Event|General Resource Internet Access|Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
10836079|NCT00182689|BG000|Baseline|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
10836080|NCT00182689|BG001|Baseline|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
10836081|NCT00182689|BG002|Baseline|Total|Total of all reporting groups
10836082|NCT00182689|FG000|Participant Flow|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
10836083|NCT00182689|FG001|Participant Flow|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
10836084|NCT00182689|OG000|Outcome|Platinum Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
10836085|NCT00182689|OG001|Outcome|Platinum Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
10836086|NCT00182689|OG000|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
10836087|NCT00182689|OG001|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
10836088|NCT00182689|OG000|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
10836089|NCT00182689|OG001|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
10836090|NCT00182689|EG000|Reported Event|Platinum Sensitive|
10836091|NCT00182689|EG001|Reported Event|Platinum Refractory|
10836092|NCT00182754|BG000|Baseline|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
10836093|NCT00182754|BG001|Baseline|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
10836094|NCT00182754|BG002|Baseline|Total|Total of all reporting groups
10836095|NCT00182754|FG000|Participant Flow|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
10836096|NCT00182754|FG001|Participant Flow|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
10836097|NCT00182754|OG000|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
10836098|NCT00182754|OG001|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
10836099|NCT00182754|EG000|Reported Event|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
10836100|NCT00182754|EG001|Reported Event|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
10836101|NCT00182767|BG000|Baseline|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836102|NCT00182767|FG000|Participant Flow|Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836103|NCT00182767|FG001|Participant Flow|Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836104|NCT00182767|FG002|Participant Flow|Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836105|NCT00182767|FG003|Participant Flow|Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836106|NCT00182767|FG004|Participant Flow|Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836107|NCT00182767|OG000|Outcome|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836108|NCT00182767|OG001|Outcome|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836109|NCT00182767|OG002|Outcome|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836110|NCT00182767|OG003|Outcome|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836111|NCT00182767|OG004|Outcome|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836112|NCT00182767|OG000|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836113|NCT00182767|OG000|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836114|NCT00182767|EG000|Reported Event|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836115|NCT00182767|EG001|Reported Event|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836116|NCT00182767|EG002|Reported Event|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836117|NCT00182767|EG003|Reported Event|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836118|NCT00182767|EG004|Reported Event|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
10836119|NCT00182793|BG000|Baseline|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
10836120|NCT00182793|FG000|Participant Flow|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
10836121|NCT00182793|OG000|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
10842890|NCT00250276|OG000|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
10842891|NCT00250276|OG001|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
11219771|NCT02329730|BG002|Baseline|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219772|NCT02329730|BG003|Baseline|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219773|NCT02329730|BG004|Baseline|Total|Total of all reporting groups
11219774|NCT02329730|FG000|Participant Flow|Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
11219775|NCT02329730|FG001|Participant Flow|Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
11219776|NCT02329730|FG002|Participant Flow|Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
11219777|NCT02329730|FG003|Participant Flow|Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
11219778|NCT02329730|FG004|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
11219779|NCT02329730|FG005|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
11219780|NCT02329730|FG006|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
11219781|NCT02329730|FG007|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
11219782|NCT02329730|FG008|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
11219783|NCT02329730|FG009|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
11219784|NCT02329730|FG010|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
11328577|NCT03430050|BG000|Baseline|Progesterone|"Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Progesterone: Progesterone capsule"
11219785|NCT02329730|FG011|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
11219786|NCT02329730|OG000|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219787|NCT02329730|OG001|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219788|NCT02329730|OG002|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219789|NCT02329730|OG003|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
11219790|NCT02329730|EG000|Reported Event|Healthy Subjects-1μg/ml ECand TB-PPD|The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219791|NCT02329730|EG001|Reported Event|Healthy Subjects-5μg/ml EC and TB-PPD|The healthy subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219792|NCT02329730|EG002|Reported Event|Healthy Subjects-10μg/ml EC and TB-PPD|The healthy subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219793|NCT02329730|EG003|Reported Event|Healthy Subjects-20μg/ml EC and TB-PPD|The healthy subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219794|NCT02329730|EG004|Reported Event|Tuberculosis Subjects- 1μg/mlEC and TB-PPD|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219795|NCT02329730|EG005|Reported Event|Tuberculosis Subjects- 5μg/ml EC and TB-PPD|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219796|NCT02329730|EG006|Reported Event|Tuberculosis Subjects- 10μg/ml EC and TB-PPD|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219797|NCT02329730|EG007|Reported Event|Tuberculosis Subjects- 20μg/ml EC and TB-PPD|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11328578|NCT03430050|BG001|Baseline|Placebo|"Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule."
10836122|NCT00182793|EG000|Reported Event|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
10836123|NCT00183092|BG000|Baseline|Placebo|Placebo : 100mg by mouth three times a day
10836124|NCT00183092|BG001|Baseline|Quinacrine|Quinacrine : 100mg by mouth three times a day
10836125|NCT00183092|BG002|Baseline|Total|Total of all reporting groups
10836126|NCT00183092|FG000|Participant Flow|Quinacrine|Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
10836127|NCT00183092|FG001|Participant Flow|Placebo|Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
10836128|NCT00183092|FG002|Participant Flow|Study Drug (Quinacrine) During Open-Label Period|Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
10836129|NCT00183092|FG003|Participant Flow|Study Drug (Placebo) During Open-Label Period|Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period
10836130|NCT00183092|OG000|Outcome|Placebo|Placebo : 100mg by mouth three times a day
10836131|NCT00183092|OG001|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
10836132|NCT00183092|EG000|Reported Event|Placebo Random Assignment|Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1).
10836133|NCT00183092|EG001|Reported Event|Quinacrine Random Assignment|Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1).
10836134|NCT00183092|EG002|Reported Event|Quinacrine Open-label|Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day
10836135|NCT00183170|BG000|Baseline|Alcohol, Then Placebo|
10836136|NCT00183170|BG001|Baseline|Placebo, Then Alcohol|
10836137|NCT00183170|BG002|Baseline|Total|Total of all reporting groups
10836138|NCT00183170|FG000|Participant Flow|Alcohol, Then Placebo|
10836139|NCT00183170|FG001|Participant Flow|Placebo, Then Alcohol|
10836140|NCT00183170|OG000|Outcome|Alcohol|Results by beverage condition.
10836141|NCT00183170|OG001|Outcome|Placebo|Results by beverage condition.
10836142|NCT00183170|EG000|Reported Event|Alcohol|Results by beverage condition.
10836143|NCT00183170|EG001|Reported Event|Placebo|Results by beverage condition.
10836144|NCT00183196|BG000|Baseline|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
10836145|NCT00183196|BG001|Baseline|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
10836146|NCT00183196|BG002|Baseline|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
10836147|NCT00183196|BG003|Baseline|Total|Total of all reporting groups
10836148|NCT00183196|FG000|Participant Flow|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
10836149|NCT00183196|FG001|Participant Flow|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
10836150|NCT00183196|FG002|Participant Flow|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
10836151|NCT00183196|OG000|Outcome|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
10836152|NCT00183196|OG001|Outcome|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
10836153|NCT00183196|OG002|Outcome|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
10836154|NCT00183196|EG000|Reported Event|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
10836155|NCT00183196|EG001|Reported Event|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
10836156|NCT00183196|EG002|Reported Event|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
10836157|NCT00183248|BG000|Baseline|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836158|NCT00183248|BG001|Baseline|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836159|NCT00183248|BG002|Baseline|Total|Total of all reporting groups
11328579|NCT03430050|BG002|Baseline|Total|Total of all reporting groups
11328580|NCT03430050|FG000|Participant Flow|Progesterone|"Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Progesterone: Progesterone capsule"
11328581|NCT03430050|FG001|Participant Flow|Placebo|"Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule."
10836160|NCT00183248|FG000|Participant Flow|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
11328582|NCT03430050|OG000|Outcome|Progesterone|"Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Progesterone: Progesterone capsule"
10836161|NCT00183248|FG001|Participant Flow|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836162|NCT00183248|OG000|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836163|NCT00183248|OG001|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836164|NCT00183248|EG000|Reported Event|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836165|NCT00183248|EG001|Reported Event|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
10836166|NCT00183274|BG000|Baseline|Venlafaxine XR|"Venlafaxine XR flexible dose of 75 - 225 mg/d~Venlafaxine XR : All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine."
10836167|NCT00183274|FG000|Participant Flow|Phase 1: Open-Label|Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
10836168|NCT00183274|FG001|Participant Flow|Phase 2: Double-Blind Venlafaxine XR|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
10836169|NCT00183274|FG002|Participant Flow|Phase 2: Double-Blind Placebo|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
10836170|NCT00183274|FG003|Participant Flow|Phase 3: Double-Blind Relapse Phase (Drug After Drug)|Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
10836171|NCT00183274|FG004|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Drug)|Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
10836172|NCT00183274|FG005|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)|Patients administered placebo in Phase 2 continued to take placebo during Phase 3
10836173|NCT00183274|OG000|Outcome|Open-Label: Venlafaxine XR|A 6-month open label administration of flexible dose Venlafaxine XR that occurred between months 1 - 6 of study.
10836174|NCT00183274|OG001|Outcome|Double-Blind Venlafaxine XR|A 6-month double-blind administration of Venlafaxine XR that occurred between months 7 - 12.
10836175|NCT00183274|OG002|Outcome|Double-Blind Placebo|A 6-month double-blind administration of placebo that occurred between months 7 - 12.
10836176|NCT00183274|OG003|Outcome|Double-Blind Relapse Drug After Drug|A 6-month double-blind administration of Venlafaxine XR that occurred between months 13 - 18.
10836177|NCT00183274|OG004|Outcome|Double-Blind Relapse Placebo After Drug|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
10836178|NCT00183274|OG005|Outcome|Double-Blind Placebo After Placebo|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
10836179|NCT00183274|OG000|Outcome|Phase 1: Open-Label Venlafaxine XR|A 6-month administration of Venlafaxine XR that occurred between months 1 - 6 of study.
10836180|NCT00183274|OG001|Outcome|Phase 2: Double-Blind Venlafaxine XR|after receiving drug in phase 1, patients continued to receive drug in phase 2
10836181|NCT00183274|OG002|Outcome|Phase 2: Double-Blind Placebo|After receiving drug in Phase 1, patients began receiving placebo in phase 2
10836182|NCT00183274|OG003|Outcome|Phase 3: Double-Blind Drug After Drug|after receiving drug in phases 1 and 2, patients continued to receive drug in phase 3
10836183|NCT00183274|OG004|Outcome|Phase 3: Placebo After Drug|after receiving drug in phases 1 and 2, patients received placebo in phase 3
10836184|NCT00183274|OG005|Outcome|Placebo After Placebo|after receiving drug in phases 1 and placebo in phase 2, patients received placebo in phase 3
10836185|NCT00183274|EG000|Reported Event|Venlafaxine XR|Adverse events were expected with venlafaxine XR. AEs were reported at least once by at least 5% of the study population for all patients who entered treatment. None of the adverse events that were expected or that occurred were considered serious or life threatening.
10836186|NCT00183339|BG000|Baseline|Placebo|Participants will take the placebo
10836187|NCT00183339|BG001|Baseline|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
10836188|NCT00183339|BG002|Baseline|Total|Total of all reporting groups
10836189|NCT00183339|FG000|Participant Flow|Placebo|Participants who received placebo solution between .5ml and 5.0ml
10836190|NCT00183339|FG001|Participant Flow|Fluoxetine|Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
10836191|NCT00183339|OG000|Outcome|Placebo|Participants will take the placebo
10836192|NCT00183339|OG001|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
10836193|NCT00183339|OG000|Outcome|Placebo|participants who were treated with flexible dose placebo solution
10836194|NCT00183339|OG001|Outcome|Fluoxetine|Participants treated with flexible dose fluoxetine solution
10836195|NCT00183339|OG001|Outcome|Fluoxetine|participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
10836196|NCT00183339|EG000|Reported Event|Placebo|participants who were treated with flexible dose placebo solution
11219798|NCT02329730|EG008|Reported Event|Tuberculosis Subjects- 1μg/ml EC and Placebo|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219799|NCT02329730|EG009|Reported Event|Tuberculosis Subjects- 5μg/ml EC and Placebo|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219800|NCT02329730|EG010|Reported Event|Tuberculosis Subjects- 10μg/ml EC and Placebo|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219801|NCT02329730|EG011|Reported Event|Tuberculosis Subjects- 20μg/ml EC and Placebo|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
11219802|NCT02329743|BG000|Baseline|RX-10045 0.05% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219803|NCT02329743|BG001|Baseline|RX-10045 0.1% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219804|NCT02329743|BG002|Baseline|Vehicle|"topical eye drops~RX-10045: topical therapy"
11219805|NCT02329743|BG003|Baseline|Total|Total of all reporting groups
11219806|NCT02329743|FG000|Participant Flow|RX-10045 0.05% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219807|NCT02329743|FG001|Participant Flow|RX-10045 0.1% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219808|NCT02329743|FG002|Participant Flow|Vehicle|"topical eye drops~RX-10045: topical therapy"
11219809|NCT02329743|OG000|Outcome|RX-10045 0.05% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219810|NCT02329743|OG001|Outcome|RX-10045 0.1% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219811|NCT02329743|OG002|Outcome|Vehicle|"topical eye drops~RX-10045: topical therapy"
11219812|NCT02329743|EG000|Reported Event|RX-10045 0.05% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219813|NCT02329743|EG001|Reported Event|RX-10045 0.1% Nanomicellar Solution|"topical eye drops~RX-10045: topical therapy"
11219814|NCT02329743|EG002|Reported Event|Vehicle|"topical eye drops~RX-10045: topical therapy"
11219815|NCT02329964|BG000|Baseline|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
11219816|NCT02329964|BG001|Baseline|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
11219817|NCT02329964|BG002|Baseline|Total|Total of all reporting groups
11219818|NCT02329964|FG000|Participant Flow|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
11219819|NCT02329964|FG001|Participant Flow|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
11219820|NCT02329964|OG000|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
11219821|NCT02329964|OG001|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
11219822|NCT02329964|EG000|Reported Event|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
11219823|NCT02329964|EG001|Reported Event|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
11219824|NCT02330055|BG000|Baseline|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
11219825|NCT02330055|BG001|Baseline|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
11219826|NCT02330055|BG002|Baseline|Total|Total of all reporting groups
11219827|NCT02330055|FG000|Participant Flow|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
11219828|NCT02330055|FG001|Participant Flow|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
11219829|NCT02330055|OG000|Outcome|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
11219830|NCT02330055|OG001|Outcome|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
10836197|NCT00183339|EG001|Reported Event|Fluoxetine|participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
11219831|NCT02330055|EG000|Reported Event|Non-elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~non-elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire"
11219832|NCT02330055|EG001|Reported Event|Forty-five Degrees Elevated Upper Body Position|"If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.~The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.~Forty-five degrees elevated upper body position~Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.~Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient."
11219833|NCT02330081|BG000|Baseline|Mirasol|"Subject will be infused with two products at the same time:~radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subjects untreated fresh whole blood.~Mirasol treatment of whole blood: Subject will be infused with two products at the same time:~radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subject's untreated fresh whole blood."
11219834|NCT02330081|FG000|Participant Flow|Mirasol|"Subject will be infused with two products at the same time:~radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subjects untreated fresh whole blood.~Mirasol treatment of whole blood: Subject will be infused with two products at the same time:~radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subject's untreated fresh whole blood."
11219835|NCT02330081|OG000|Outcome|Test Platelets From Mirasol-treated Whole Blood|Mirasol-treated platelets: Platelets were collected from 1 Test unit of whole blood that had been treated with the Mirasol pathogen reduction process and stored for 24 hours.
11219836|NCT02330081|OG001|Outcome|Control Platelets|Control platelets: An aliquot of platelets derived from a freshly collected whole blood sample
11219837|NCT02330081|OG000|Outcome|Mirasol-treated Whole Blood|1 unit of WB tested at the time of collection, immediately following Mirasol treatment, and 24 hours after Mirasol treatment.
11219838|NCT02330081|OG000|Outcome|Mirasol|"Subject will be infused with two products at the same time:~radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subjects untreated fresh whole blood."
11219839|NCT02330081|EG000|Reported Event|Mirasol|"Subject will be infused with two products at the same time:~radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.~radio-labeled platelets derived from subjects untreated fresh whole blood."
11219840|NCT02330094|BG000|Baseline|Gabapentin|"Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219841|NCT02330094|BG001|Baseline|Control|"Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219842|NCT02330094|BG002|Baseline|Total|Total of all reporting groups
11219843|NCT02330094|FG000|Participant Flow|Gabapentin|"Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219844|NCT02330094|FG001|Participant Flow|Control|"Placebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219845|NCT02330094|OG000|Outcome|Gabapentin|"Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219846|NCT02330094|OG001|Outcome|Control|"Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219847|NCT02330094|EG000|Reported Event|Gabapentin|"Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219848|NCT02330094|EG001|Reported Event|Control|"Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.~Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.~Both groups will receive other standard of care pain medications."
11219849|NCT02330172|BG000|Baseline|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219850|NCT02330172|BG001|Baseline|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219851|NCT02330172|BG002|Baseline|Total|Total of all reporting groups
11219852|NCT02330172|FG000|Participant Flow|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219853|NCT02330172|FG001|Participant Flow|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219854|NCT02330172|OG000|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219855|NCT02330172|OG001|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219856|NCT02330172|EG000|Reported Event|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219857|NCT02330172|EG001|Reported Event|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
11219858|NCT02330276|BG000|Baseline|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219859|NCT02330276|BG001|Baseline|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219860|NCT02330276|BG002|Baseline|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219861|NCT02330276|BG003|Baseline|Total|Total of all reporting groups
11219862|NCT02330276|FG000|Participant Flow|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219863|NCT02330276|FG001|Participant Flow|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219864|NCT02330276|FG002|Participant Flow|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219865|NCT02330276|OG000|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219866|NCT02330276|OG001|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219867|NCT02330276|OG002|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219868|NCT02330276|EG000|Reported Event|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219869|NCT02330276|EG001|Reported Event|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219870|NCT02330276|EG002|Reported Event|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
11219871|NCT02330341|BG000|Baseline|Artemisia Dracunculus|"Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Artemisia dracunculus"
11219872|NCT02330341|BG001|Baseline|Placebo|"Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Placebo"
11219873|NCT02330341|BG002|Baseline|Total|Total of all reporting groups
11219874|NCT02330341|FG000|Participant Flow|Artemisia Dracunculus|"Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Artemisia dracunculus"
11219875|NCT02330341|FG001|Participant Flow|Placebo|"Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Placebo"
11219876|NCT02330341|OG000|Outcome|Artemisia Dracunculus|"Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Artemisia dracunculus"
11219877|NCT02330341|OG001|Outcome|Placebo|"Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Placebo"
11219878|NCT02330341|EG000|Reported Event|Artemisia Dracunculus|"Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Artemisia dracunculus"
11219879|NCT02330341|EG001|Reported Event|Placebo|"Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days~Placebo"
11219880|NCT02330523|BG000|Baseline|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219881|NCT02330523|BG001|Baseline|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219882|NCT02330523|BG002|Baseline|Total|Total of all reporting groups
10836198|NCT00183391|BG000|Baseline|Atomoxetine Then Methylphenidate|Participants randomized to receive Atomoxetine until optimal response, then washed out and crossed-over to receive Methylphenidate.
10836199|NCT00183391|BG001|Baseline|Methylphenidate Then Atomoxetine|Participants randomized to receive Methylphenidate until optimal response, then washed out and crossed-over to receive Atomoxetine.
10836200|NCT00183391|BG002|Baseline|Total|Total of all reporting groups
10836201|NCT00183391|FG000|Participant Flow|Atomoxetine Then Methylphenidate|Participants randomized to receive Atomoxetine until optimal response, then washed out and crossed-over to receive Methylphenidate.
10836202|NCT00183391|FG001|Participant Flow|Methylphenidate Then Atomoxetine|Participants randomized to receive Methylphenidate until optimal response, then washed out and crossed-over to receive Atomoxetine.
10836203|NCT00183391|OG000|Outcome|Atomoxetine Then Methylphenidate|Block 1 receiving Atomoxetine first, washout period, then Block 2 receiving Methylphenidate
10836204|NCT00183391|OG001|Outcome|Methylphenidate Then Atomoxetine|Block 1 receiving Methylphenidate first, washout period, then Block 2 receiving Atomoxetine
10836205|NCT00183391|EG000|Reported Event|Block 1 ATX|Block 1 first four weeks received Atomoxetine
10836206|NCT00183391|EG001|Reported Event|Block 1 MPH|Block 1 first four weeks received Methylphenidate
10836207|NCT00183391|EG002|Reported Event|Block 2 ATX|Block 2 (weeks 8 to 13) received Atomoxetine
10836208|NCT00183391|EG003|Reported Event|Block 2 MPH|Block 2 (weeks 8 to 13) received Methylphenidate
10836209|NCT00183430|BG000|Baseline|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836210|NCT00183430|BG001|Baseline|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836211|NCT00183430|BG002|Baseline|Total|Total of all reporting groups
10836212|NCT00183430|FG000|Participant Flow|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836213|NCT00183430|FG001|Participant Flow|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836214|NCT00183430|OG000|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836215|NCT00183430|OG001|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836216|NCT00183430|EG000|Reported Event|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836217|NCT00183430|EG001|Reported Event|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
10836218|NCT00183443|BG000|Baseline|DVP + Placebo|"Participants will receive divalproex ER at a therapeutic dose, plus placebo~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks."
10836219|NCT00183443|BG001|Baseline|DVP + Quetiapine|"Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills."
10836220|NCT00183443|BG002|Baseline|DVP + Lithium|"Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L."
10836221|NCT00183443|BG003|Baseline|Total|Total of all reporting groups
10836222|NCT00183443|FG000|Participant Flow|DVP + Placebo|"Participants will receive divalproex ER at a therapeutic dose, plus placebo~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks."
10836223|NCT00183443|FG001|Participant Flow|DVP + Quetiapine|"Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills."
10836224|NCT00183443|FG002|Participant Flow|DVP + Lithium|"Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L."
11328583|NCT03430050|OG001|Outcome|Placebo|"Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule."
10836225|NCT00183443|OG000|Outcome|DVP + Placebo|"Participants will receive divalproex ER at a therapeutic dose, plus placebo~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks."
10836226|NCT00183443|OG001|Outcome|DVP + Quetiapine|"Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills."
10836227|NCT00183443|OG002|Outcome|DVP + Lithium|"Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L."
10836228|NCT00183443|EG000|Reported Event|DVP + Placebo|"Participants will receive divalproex ER at a therapeutic dose, plus placebo~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks."
10836229|NCT00183443|EG001|Reported Event|DVP + Quetiapine|"Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills."
10836230|NCT00183443|EG002|Reported Event|DVP + Lithium|"Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level~Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.~Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L."
10836231|NCT00183456|BG000|Baseline|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
10836232|NCT00183456|BG001|Baseline|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
10836233|NCT00183456|BG002|Baseline|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
10836234|NCT00183456|BG003|Baseline|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
10836235|NCT00183456|BG004|Baseline|Total|Total of all reporting groups
10836236|NCT00183456|FG000|Participant Flow|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
10836237|NCT00183456|FG001|Participant Flow|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
10836238|NCT00183456|FG002|Participant Flow|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
11328584|NCT03430050|EG000|Reported Event|Progesterone|"Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Progesterone: Progesterone capsule"
10836239|NCT00183456|FG003|Participant Flow|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
10836240|NCT00183456|OG000|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
10836241|NCT00183456|OG001|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
10836242|NCT00183456|OG002|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
10836243|NCT00183456|OG003|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
10836244|NCT00183456|EG000|Reported Event|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
10836245|NCT00183456|EG001|Reported Event|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
10836246|NCT00183456|EG002|Reported Event|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
11219883|NCT02330523|FG000|Participant Flow|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219884|NCT02330523|FG001|Participant Flow|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219885|NCT02330523|OG000|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219886|NCT02330523|OG001|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219887|NCT02330523|EG000|Reported Event|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219888|NCT02330523|EG001|Reported Event|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
11219889|NCT02330549|BG000|Baseline|Cenicriviroc 150 mg|Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
11219890|NCT02330549|BG001|Baseline|Placebo|Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
11219891|NCT02330549|BG002|Baseline|Total|Total of all reporting groups
11219892|NCT02330549|FG000|Participant Flow|Cenicriviroc 150 mg|Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
11219893|NCT02330549|FG001|Participant Flow|Placebo|Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
11219894|NCT02330549|OG000|Outcome|Cenicriviroc 150 mg|Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
11219895|NCT02330549|OG001|Outcome|Placebo|Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
11219896|NCT02330549|EG000|Reported Event|Cenicriviroc 150 mg|Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
11219897|NCT02330549|EG001|Reported Event|Placebo|Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
11219898|NCT02330588|BG000|Baseline|Intervention Arm (Eat It, Injunctive Feedback)|
11219899|NCT02330588|BG001|Baseline|Intervention Arm (Eat It, Normative Feedback)|
11219900|NCT02330588|BG002|Baseline|Intervention Arm (Move It, Injunctive Feedback)|
11219901|NCT02330588|BG003|Baseline|Intervention Arm (Move It, Normative Feedback)|
11219902|NCT02330588|BG004|Baseline|eHealth Control Arm (Heads Up)|
11219903|NCT02330588|BG005|Baseline|Total|Total of all reporting groups
11219904|NCT02330588|FG000|Participant Flow|Eat It (Injunctive Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
11219905|NCT02330588|FG001|Participant Flow|Eat It (Normative Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).
10836247|NCT00183456|EG003|Reported Event|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
10836248|NCT00183469|BG000|Baseline|Lamotrigine Plus Divalproex ER|Enrolled subjects received lamotrigine and divalproex ER
10836249|NCT00183469|BG001|Baseline|Lamotrigine Plus Placebo Divalproex ER|
10836250|NCT00183469|BG002|Baseline|Total|Total of all reporting groups
10836251|NCT00183469|FG000|Participant Flow|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
10836252|NCT00183469|FG001|Participant Flow|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
10836253|NCT00183469|OG000|Outcome|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
10836254|NCT00183469|OG001|Outcome|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
10836255|NCT00183469|EG000|Reported Event|Lamotrigine Plus Active Divalproex ER|randomized participants will take active lamotrigine and active divalproex Er
10836256|NCT00183469|EG001|Reported Event|Lamotrigine Plus Placebo Divalproex ER|randomized subjects will take active lamotrigine and placebo divalproex ER
10836257|NCT00183625|BG000|Baseline|Risperidone Treatment|
10836258|NCT00183625|BG001|Baseline|Olanzapine Treatment|
10836259|NCT00183625|BG002|Baseline|Total|Total of all reporting groups
10836260|NCT00183625|FG000|Participant Flow|Risperidone Plus Supported Employment|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
10836261|NCT00183625|FG001|Participant Flow|Olanzapine Plus Supported Employment|Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
10836262|NCT00183625|FG002|Participant Flow|Risperidone + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
10836263|NCT00183625|FG003|Participant Flow|Olanzapine + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
10836264|NCT00183625|OG000|Outcome|Individual Placement and Support (IPS)|IPS alone for risperidone and olanzapine subjects
10836265|NCT00183625|OG001|Outcome|Individual Placement and Support With Workplace Fundamentals|Olanzapine and Risperidone Patients included.
10836266|NCT00183625|OG000|Outcome|Risperidone Treatment|
10836267|NCT00183625|OG001|Outcome|Olanzapine Treatment|
10836268|NCT00183625|EG000|Reported Event|Risperidone Treatment|
10836269|NCT00183625|EG001|Reported Event|Olanzapine Treatment|
10836270|NCT00183677|BG000|Baseline|Open Label Escitalopram|Participants will receive treatment with escitalopram.
10836271|NCT00183677|FG000|Participant Flow|Open Label Escitalopram|Participants will receive treatment with escitalopram.
10836272|NCT00183677|OG000|Outcome|Open Label Escitalopram|Participants received open treatment with escitalopram.
10836273|NCT00183677|EG000|Reported Event|Open Label Escitalopram|Participants will receive treatment with escitalopram.
10836274|NCT00183729|BG000|Baseline|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
10836275|NCT00183729|BG001|Baseline|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
10836276|NCT00183729|BG002|Baseline|Total|Total of all reporting groups
10836277|NCT00183729|FG000|Participant Flow|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
10836278|NCT00183729|FG001|Participant Flow|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
10836279|NCT00183729|OG000|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
10836280|NCT00183729|OG001|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
10836281|NCT00183729|EG000|Reported Event|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
10836282|NCT00183729|EG001|Reported Event|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
10836283|NCT00183794|BG000|Baseline|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
10836284|NCT00183794|FG000|Participant Flow|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
10836285|NCT00183794|OG000|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
10836286|NCT00183794|EG000|Reported Event|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
10836287|NCT00183872|BG000|Baseline|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
10836288|NCT00183872|FG000|Participant Flow|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
10836289|NCT00183872|OG000|Outcome|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
11219906|NCT02330588|FG002|Participant Flow|Move It (Injunctive Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
11219907|NCT02330588|FG003|Participant Flow|Move It (Normative Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).
11219908|NCT02330588|FG004|Participant Flow|eHealth Control|Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).
11219909|NCT02330588|OG000|Outcome|All Groups (Total)|All groups (four brief interventions + eHealth control)
11219910|NCT02330588|OG001|Outcome|Eat It (Injunctive Feedback)|
11219911|NCT02330588|OG002|Outcome|Eat It (Normative Feedback)|
11219912|NCT02330588|OG003|Outcome|Move It (Injunctive Feedback)|
11219913|NCT02330588|OG004|Outcome|Move It (Normative Feedback)|
11219914|NCT02330588|OG005|Outcome|eHealth Control|
11219915|NCT02330588|OG000|Outcome|Feasibility (Uptake)|All groups (brief intervention + eHealth control)
11219916|NCT02330588|OG000|Outcome|Eat It (Injunctive Feedback)|
11219917|NCT02330588|OG001|Outcome|Eat It (Normative Feedback)|
11219918|NCT02330588|OG002|Outcome|Move It (Injunctive Feedback)|
11219919|NCT02330588|OG003|Outcome|Move It (Normative Feedback)|
11219920|NCT02330588|OG004|Outcome|Heads Up (eHealth Control)|
11219921|NCT02330588|OG005|Outcome|All Groups (Total)|
11219922|NCT02330588|EG000|Reported Event|Eat It (Injunctive)|
11219923|NCT02330588|EG001|Reported Event|Eat It (Normative)|
11219924|NCT02330588|EG002|Reported Event|Move It (Injunctive)|
11219925|NCT02330588|EG003|Reported Event|Move It (Normative)|
11219926|NCT02330588|EG004|Reported Event|eHealth Control|
11219927|NCT02330627|BG000|Baseline|Positive Valence System Treatment|"10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.~Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions."
11219928|NCT02330627|BG001|Baseline|Delayed Treatment (Waitlist)|
11219929|NCT02330627|BG002|Baseline|Total|Total of all reporting groups
11219930|NCT02330627|FG000|Participant Flow|Positive Valence System Treatment|"10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.~Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions."
11219931|NCT02330627|FG001|Participant Flow|Delayed Treatment (Waitlist)|No treatment received for 10 weeks
11219932|NCT02330627|OG000|Outcome|Positive Valence System Treatment|"10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.~Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions."
11219933|NCT02330627|OG001|Outcome|Delayed Treatment (Waitlist)|
11219934|NCT02330627|EG000|Reported Event|Positive Valence System Treatment|"10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.~Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions."
11219935|NCT02330627|EG001|Reported Event|Delayed Treatment (Waitlist)|
11219936|NCT02330978|BG000|Baseline|The First Patient Included at Study|On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
11219937|NCT02330978|FG000|Participant Flow|MSC Transplantion|"One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eye, through an unique intravitreal injections, under anesthesia.~Intravitreal transplantation of mesenchymal stem cell~Culture and isolation of autologous bone-marrow mesenchymal stem cells"
11219938|NCT02330978|OG000|Outcome|The First Patient Included at Study|On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
11219939|NCT02330978|EG000|Reported Event|The First Patient Included at Study|On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
11219940|NCT02331095|BG000|Baseline|Anticoagulation|Patients will be treated with warfarin with dose adjusted to goal International Normalized Ratio (INR) of 2-3 or rivaroxaban standard dose (15 mg twice daily for 3 weeks then 20 mg daily)
11328585|NCT03430050|EG001|Reported Event|Placebo|"Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.~Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule."
11328586|NCT03430206|BG000|Baseline|Standard of Care|Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
11328587|NCT03430206|BG001|Baseline|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
11328588|NCT03430206|BG002|Baseline|Total|Total of all reporting groups
11328589|NCT03430206|FG000|Participant Flow|Standard of Care|Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
11219941|NCT02331095|BG001|Baseline|Atorvastatin + Anticoagulation|"In addition to warfarin or rivaroxaban as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3.~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP)."
11219942|NCT02331095|BG002|Baseline|Total|Total of all reporting groups
11219943|NCT02331095|FG000|Participant Flow|Anticoagulation|Patients will be treated with warfarin with dose adjusted to goal International Normalized Ratio (INR) of 2-3 or rivaroxaban standard dose (15 mg twice daily for 3 weeks then 20 mg daily)
11219944|NCT02331095|FG001|Participant Flow|Atorvastatin + Anticoagulation|"In addition to warfarin or rivaroxaban as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3.~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP)."
11219945|NCT02331095|OG000|Outcome|Anticoagulation|Patients will be treated with warfarin with dose adjusted to goal International Normalized Ratio (INR) of 2-3 or rivaroxaban standard dose (15 mg twice daily for 3 weeks then 20 mg daily)
11219946|NCT02331095|OG001|Outcome|Atorvastatin + Anticoagulation|"In addition to warfarin or rivaroxaban as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3."
11219947|NCT02331095|OG001|Outcome|Atorvastatin + Anticoagulation|"In addition to warfarin or rivaroxaban as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3.~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP)."
11219948|NCT02331095|OG001|Outcome|Atorvastatin + Anticoagulation|"In addition to standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for the study period of 9 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Anticoagulation Therapy: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3."
11219949|NCT02331095|OG000|Outcome|Anticoagulation|"Patients will be treated with warfarin as standard anticoagulation, dose adjusted to goal International Normalized Ratio (INR) of 2-3~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3."
11219950|NCT02331095|OG001|Outcome|Atorvastatin + Anticoagulation|"In addition to warfarin as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3."
11219951|NCT02331095|EG000|Reported Event|Anticoagulation|Patients will be treated with warfarin with dose adjusted to goal International Normalized Ratio (INR) of 2-3 or rivaroxaban standard dose (15 mg twice daily for 3 weeks then 20 mg daily)
11219952|NCT02331095|EG001|Reported Event|Atorvastatin + Anticoagulation|"In addition to warfarin or rivaroxaban as standard anticoagulation, patients will be given concurrent atorvastatin 40 mg daily for 3 months, starting from the time of enrollment~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP).~Warfarin: Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3.~Atorvastatin: Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP)."
11219953|NCT02331108|BG000|Baseline|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219954|NCT02331108|BG001|Baseline|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219955|NCT02331108|BG002|Baseline|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219956|NCT02331108|BG003|Baseline|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219957|NCT02331108|BG004|Baseline|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219958|NCT02331108|BG005|Baseline|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219959|NCT02331108|BG006|Baseline|Total|Total of all reporting groups
11219960|NCT02331108|FG000|Participant Flow|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219961|NCT02331108|FG001|Participant Flow|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219962|NCT02331108|FG002|Participant Flow|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219963|NCT02331108|FG003|Participant Flow|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219964|NCT02331108|FG004|Participant Flow|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219965|NCT02331108|FG005|Participant Flow|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219966|NCT02331108|OG000|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219967|NCT02331108|OG001|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219968|NCT02331108|OG002|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219969|NCT02331108|OG003|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219970|NCT02331108|OG004|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219971|NCT02331108|OG005|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
10836290|NCT00183872|EG000|Reported Event|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
10836291|NCT00184002|BG000|Baseline|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
10836292|NCT00184002|FG000|Participant Flow|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
10836293|NCT00184002|OG000|Outcome|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
10836294|NCT00184002|EG000|Reported Event|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5.~Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1"
10836295|NCT00184028|BG000|Baseline|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
10836296|NCT00184028|FG000|Participant Flow|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
10836297|NCT00184028|OG000|Outcome|Arm 1|Single arm study
10836298|NCT00184028|OG000|Outcome|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
10836299|NCT00184028|EG000|Reported Event|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
10836300|NCT00184054|BG000|Baseline|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
10836301|NCT00184054|FG000|Participant Flow|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
10836302|NCT00184054|OG000|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
10836303|NCT00184054|EG000|Reported Event|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
10836304|NCT00184093|BG000|Baseline|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
10836305|NCT00184093|FG000|Participant Flow|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
10836306|NCT00184093|OG000|Outcome|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
11219972|NCT02331108|OG000|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219973|NCT02331108|OG001|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219974|NCT02331108|EG000|Reported Event|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219975|NCT02331108|EG001|Reported Event|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219976|NCT02331108|EG002|Reported Event|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219977|NCT02331108|EG003|Reported Event|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219978|NCT02331108|EG004|Reported Event|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219979|NCT02331108|EG005|Reported Event|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
11219980|NCT02331368|BG000|Baseline|Anti-PD-1 (MK-3475)|"Study Treatment:~200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses."
11219981|NCT02331368|FG000|Participant Flow|Anti-PD-1 (MK-3475)|"Study Treatment:~200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses."
11219982|NCT02331368|OG000|Outcome|Anti-PD-1 (MK-3475)|"Study Treatment:~200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses."
11219983|NCT02331368|EG000|Reported Event|Anti-PD-1 (MK-3475)|"Study Treatment:~200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses."
11219984|NCT02331394|BG000|Baseline|Chinese Herbs Formula: Shu Yu Wan|All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.
11219985|NCT02331394|FG000|Participant Flow|Chinese Herbs Formula|A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected Chinese herbs (CH) formula in patients with stage 4 non-small cell lung cancer (NSCLC). All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard of care. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for 6 weeks.
11219986|NCT02331394|OG000|Outcome|A Single Arm, Prospective Study|Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks
11219987|NCT02331394|OG000|Outcome|Baseline|The Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher scores is considered better.
11219988|NCT02331394|OG001|Outcome|6 Weeks|Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
11219989|NCT02331394|OG000|Outcome|Baseline|Physical Well-Being (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse
11219990|NCT02331394|OG001|Outcome|6 Weeks|Physical Well-Being (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse
11219991|NCT02331394|OG000|Outcome|A Single Arm, Prospective Study|A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected CH formula in patients with stage 4 NSCLC at our center. Patients with stage 4 NSCLC were eligible if they had Eastern Cooperative Oncology Group performance status of 0-2 and had not used CHs. In addition, to ensure that no CH-related side effects were misattributed to chemotherapy, only patients who had completed at least one cycle of their current standard chemotherapy and were clinically stable were eligible. Patients who were not on treatment were also eligible if there was no plan to recommence the treatment within the next 6 weeks. To safeguard those who were perceived to be potentially at increased risk of side effects from CHs, patients with active brain metastases, abnormal liver function or those taking tyrosine kinase inhibitors, immunosuppressive drugs, anticonvulsant and anticoagulant medications were excluded.
11219992|NCT02331394|OG000|Outcome|Baseline|Edmonton Symptom Assessment System
11219993|NCT02331394|OG001|Outcome|6 Weeks|Edmonton Symptom Assessment System
10836307|NCT00184093|EG000|Reported Event|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
10836308|NCT00184548|BG000|Baseline|rFVIIa, Blunt Trauma|
10836309|NCT00184548|BG001|Baseline|Placebo, Blunt Trauma|
10836310|NCT00184548|BG002|Baseline|rFVIIa, Penetrating Trauma|
10836311|NCT00184548|BG003|Baseline|Placebo, Penetrating Trauma|
10836312|NCT00184548|BG004|Baseline|Total|Total of all reporting groups
10836313|NCT00184548|FG000|Participant Flow|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836314|NCT00184548|FG001|Participant Flow|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836315|NCT00184548|FG002|Participant Flow|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836316|NCT00184548|FG003|Participant Flow|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836317|NCT00184548|OG000|Outcome|rFVIIa, Blunt Trauma|
10836318|NCT00184548|OG001|Outcome|Placebo, Blunt Trauma|
10836319|NCT00184548|OG002|Outcome|rFVIIa, Penetrating Trauma|
10836320|NCT00184548|OG003|Outcome|Placebo, Penetrating Trauma|
10836321|NCT00184548|EG000|Reported Event|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836322|NCT00184548|EG001|Reported Event|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836323|NCT00184548|EG002|Reported Event|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836324|NCT00184548|EG003|Reported Event|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
10836325|NCT00184600|BG000|Baseline|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
10836326|NCT00184600|BG001|Baseline|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
10836327|NCT00184600|BG002|Baseline|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
10836328|NCT00184600|BG003|Baseline|Total|Total of all reporting groups
10842892|NCT00250276|EG000|Reported Event|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
11328590|NCT03430206|FG001|Participant Flow|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
10836329|NCT00184600|FG000|Participant Flow|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
10836330|NCT00184600|FG001|Participant Flow|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
10836331|NCT00184600|FG002|Participant Flow|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
10836332|NCT00184600|OG000|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
10836333|NCT00184600|OG001|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
10836334|NCT00184600|OG002|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
10836335|NCT00184600|EG000|Reported Event|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
10836336|NCT00184600|EG001|Reported Event|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
11328591|NCT03430206|OG000|Outcome|Standard of Care|Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
11219994|NCT02331394|EG000|Reported Event|A Single Arm, Prospective Study|A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected CH formula in patients with stage 4 NSCLC at our center. Patients with stage 4 NSCLC were eligible if they had Eastern Cooperative Oncology Group performance status of 0-2 and had not used CHs. In addition, to ensure that no CH-related side effects were misattributed to chemotherapy, only patients who had completed at least one cycle of their current standard chemotherapy and were clinically stable were eligible. Patients who were not on treatment were also eligible if there was no plan to recommence the treatment within the next 6 weeks. To safeguard those who were perceived to be potentially at increased risk of side effects from CHs, patients with active brain metastases, abnormal liver function or those taking tyrosine kinase inhibitors, immunosuppressive drugs, anticonvulsant and anticoagulant medications were excluded.
11219995|NCT02331407|BG000|Baseline|Robot Arm Rehabilitation Therapy|"Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.~Robotic arm therapy: Training with the ReoGo device"
11219996|NCT02331407|FG000|Participant Flow|Robot Arm Rehabilitation Therapy|"Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.~Robotic arm therapy: Training with the ReoGo device"
11219997|NCT02331407|OG000|Outcome|Robot Arm Rehabilitation Therapy|"Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.~Robotic arm therapy: Training with the ReoGo device"
11219998|NCT02331407|EG000|Reported Event|Robot Arm Rehabilitation Therapy|"Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.~Robotic arm therapy: Training with the ReoGo device"
11219999|NCT02331446|BG000|Baseline|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
11220000|NCT02331446|BG001|Baseline|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
11220001|NCT02331446|BG002|Baseline|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
11220002|NCT02331446|BG003|Baseline|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
11220003|NCT02331446|BG004|Baseline|Total|Total of all reporting groups
11220004|NCT02331446|FG000|Participant Flow|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
11220005|NCT02331446|FG001|Participant Flow|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
11220006|NCT02331446|FG002|Participant Flow|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
11220007|NCT02331446|FG003|Participant Flow|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
11220008|NCT02331446|OG000|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
11220009|NCT02331446|OG001|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
11220010|NCT02331446|OG002|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
11220011|NCT02331446|OG003|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
11220012|NCT02331446|EG000|Reported Event|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
11220013|NCT02331446|EG001|Reported Event|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
11220014|NCT02331446|EG002|Reported Event|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
11220015|NCT02331446|EG003|Reported Event|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
11220016|NCT02331589|BG000|Baseline|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
11220017|NCT02331589|BG001|Baseline|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
11220018|NCT02331589|BG002|Baseline|Total|Total of all reporting groups
11220019|NCT02331589|FG000|Participant Flow|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
11220020|NCT02331589|FG001|Participant Flow|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
11220021|NCT02331589|OG000|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
11220022|NCT02331589|OG001|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
11220023|NCT02331589|EG000|Reported Event|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
11328592|NCT03430206|OG001|Outcome|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
10836337|NCT00184600|EG002|Reported Event|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
10836338|NCT00184717|BG000|Baseline|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836339|NCT00184717|BG001|Baseline|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836340|NCT00184717|BG002|Baseline|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
10836341|NCT00184717|BG003|Baseline|Total|Total of all reporting groups
10836342|NCT00184717|FG000|Participant Flow|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836343|NCT00184717|FG001|Participant Flow|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836344|NCT00184717|FG002|Participant Flow|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
10836345|NCT00184717|FG003|Participant Flow|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
10836346|NCT00184717|FG004|Participant Flow|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
10836347|NCT00184717|OG000|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836348|NCT00184717|OG001|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
10836349|NCT00184717|OG002|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
10836350|NCT00184717|OG003|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
10836351|NCT00184717|EG000|Reported Event|0.033 mg / NN-220|
10836352|NCT00184717|EG001|Reported Event|0.067 mg / NN-220|
10836353|NCT00184717|EG002|Reported Event|0.033 mg / No Treatment|
10836354|NCT00184717|EG003|Reported Event|0.067 mg / No Treatment|
10836355|NCT00185211|BG000|Baseline|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
10836356|NCT00185211|BG001|Baseline|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
10836357|NCT00185211|BG002|Baseline|Total|Total of all reporting groups
10836358|NCT00185211|FG000|Participant Flow|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
10836359|NCT00185211|FG001|Participant Flow|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
10836360|NCT00185211|OG000|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
10836361|NCT00185211|OG001|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
10836362|NCT00185211|OG000|Outcome|All Subjects|All subjects part of Intention-To-Treat (ITT) Population
10836363|NCT00185211|EG000|Reported Event|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
10836364|NCT00185211|EG001|Reported Event|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
10836365|NCT00185380|BG000|Baseline|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
10836366|NCT00185380|BG001|Baseline|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
10836367|NCT00185380|BG002|Baseline|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
10836368|NCT00185380|BG003|Baseline|Total|Total of all reporting groups
11220024|NCT02331589|EG001|Reported Event|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
11220025|NCT02331680|BG000|Baseline|OPC-41061 15mg/Day|OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220026|NCT02331680|BG001|Baseline|OPC-41061 30mg/Day|OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220027|NCT02331680|BG002|Baseline|Placebo|OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220028|NCT02331680|BG003|Baseline|Total|Total of all reporting groups
11220029|NCT02331680|FG000|Participant Flow|OPC-41061 15mg/Day|OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220030|NCT02331680|FG001|Participant Flow|OPC-41061 30mg/Day|OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220031|NCT02331680|FG002|Participant Flow|Placebo|OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220032|NCT02331680|OG000|Outcome|OPC-41061 15mg/Day|OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220033|NCT02331680|OG001|Outcome|OPC-41061 30mg/Day|OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220034|NCT02331680|OG002|Outcome|Placebo|OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220035|NCT02331680|EG000|Reported Event|OPC-41061 15mg/Day|OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220036|NCT02331680|EG001|Reported Event|OPC-41061 30mg/Day|OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220037|NCT02331680|EG002|Reported Event|Placebo|OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
11220038|NCT02331940|BG000|Baseline|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
11220039|NCT02331940|BG001|Baseline|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
11220040|NCT02331940|BG002|Baseline|Total|Total of all reporting groups
11220041|NCT02331940|FG000|Participant Flow|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
11220042|NCT02331940|FG001|Participant Flow|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
11220043|NCT02331940|OG000|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
11220044|NCT02331940|OG001|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
11220045|NCT02331940|EG000|Reported Event|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
11220046|NCT02331940|EG001|Reported Event|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
11220047|NCT02331992|BG000|Baseline|Positive Airway Pressure Adherence Program|"Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.~Adherence program: Participants will receive supportive messages while enrolled in the program."
11220048|NCT02331992|FG000|Participant Flow|Positive Airway Pressure Adherence Program|"Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.~Adherence program: Participants will receive supportive messages while enrolled in the program."
11220049|NCT02331992|OG000|Outcome|Positive Airway Pressure Adherence Program|"Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.~Adherence program: Participants will receive supportive messages while enrolled in the program."
11220050|NCT02331992|EG000|Reported Event|Positive Airway Pressure Adherence Program|"Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.~Adherence program: Participants will receive supportive messages while enrolled in the program."
11328593|NCT03430206|EG000|Reported Event|Standard of Care|Control subjects will undergo their scheduled procedure and recovery with the usual standard care.
11328594|NCT03430206|EG001|Reported Event|THRIVE|Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system).
10836369|NCT00185380|FG000|Participant Flow|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
10836370|NCT00185380|FG001|Participant Flow|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
10836371|NCT00185380|FG002|Participant Flow|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
10836372|NCT00185380|OG000|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
10836373|NCT00185380|OG001|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
10836374|NCT00185380|OG002|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
10836375|NCT00185380|EG000|Reported Event|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
10836376|NCT00185380|EG001|Reported Event|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
10836377|NCT00185380|EG002|Reported Event|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
10836378|NCT00185458|BG000|Baseline|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
10836379|NCT00185458|FG000|Participant Flow|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
10836380|NCT00185458|OG000|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
10836381|NCT00185458|OG001|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
10836382|NCT00185458|OG002|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
10836383|NCT00185458|OG003|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
10836384|NCT00185458|OG004|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
10836385|NCT00185458|OG000|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
10836386|NCT00185458|OG000|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
10836387|NCT00185458|OG001|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
10836388|NCT00185458|OG002|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
10836389|NCT00185458|EG000|Reported Event|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
10836390|NCT00185588|BG000|Baseline|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836391|NCT00185588|BG001|Baseline|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836392|NCT00185588|BG002|Baseline|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836393|NCT00185588|BG003|Baseline|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836394|NCT00185588|BG004|Baseline|Total|Total of all reporting groups
10836395|NCT00185588|FG000|Participant Flow|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
11220051|NCT02332239|BG000|Baseline|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
11220052|NCT02332239|BG001|Baseline|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
11220053|NCT02332239|BG002|Baseline|Total|Total of all reporting groups
11220054|NCT02332239|FG000|Participant Flow|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
11220055|NCT02332239|FG001|Participant Flow|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
11220056|NCT02332239|OG000|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
11220057|NCT02332239|OG001|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
11220058|NCT02332239|OG000|Outcome|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
11220059|NCT02332239|OG001|Outcome|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
11220060|NCT02332239|EG000|Reported Event|iDOVE Intervention (ED+Text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention~Eight-week longitudinal tailored CBT-based text-message program~iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program"
11220061|NCT02332239|EG001|Reported Event|Control (EUC)|"In-ED brief session, discussing home safety & nutrition~Eight-week longitudinal home safety & nutrition text-message program~Control (EUC): 1) In-ED brief session, discussing home safety & nutrition 2) Eight-week longitudinal home safety & nutrition text-message program"
11220062|NCT02332291|BG000|Baseline|Blinded Escitalopram / Open-Label Bupropion|"8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl~Escitalopram: Escitalopram 10-20mg daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220063|NCT02332291|BG001|Baseline|Blinded Placebo / Open-Label Bupropion|"8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl~Placebo: 1-2 tablets daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220064|NCT02332291|BG002|Baseline|Total|Total of all reporting groups
11220065|NCT02332291|FG000|Participant Flow|Blinded Escitalopram / Open-Label Bupropion|"8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl~Escitalopram: Escitalopram 10-20mg daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220066|NCT02332291|FG001|Participant Flow|Blinded Placebo / Open-Label Bupropion|"8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl~Placebo: 1-2 tablets daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220067|NCT02332291|OG000|Outcome|Blinded Escitalopram / Open-Label Bupropion|"8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl~Escitalopram: Escitalopram 10-20mg daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220068|NCT02332291|OG001|Outcome|Blinded Placebo / Open-Label Bupropion|"8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl~Placebo: 1-2 tablets daily~Bupropion XL: Bupropion XL 150-450mg daily"
11220069|NCT02332291|OG000|Outcome|Blinded Escitalopram|"8 weeks of blinded escitalopram.~Escitalopram: Escitalopram 10-20mg daily"
11220070|NCT02332291|OG001|Outcome|Blinded Placebo|"8 weeks of blinded placebo.~Placebo: 1-2 tablets daily"
11220071|NCT02332291|OG000|Outcome|Open-label Bupropion XL|"Bupropion XL was administered open-label for 8 weeks with flexible dosing.~Bupropion XL: Bupropion XL 150-450mg daily"
11220072|NCT02332291|EG000|Reported Event|Blinded Escitalopram|"8 weeks of blinded escitalopram~Escitalopram: Escitalopram 10-20mg daily"
11220073|NCT02332291|EG001|Reported Event|Blinded Placebo|"8 weeks of blinded placebo~Placebo: Placebo 1-2 tablets daily"
11220074|NCT02332291|EG002|Reported Event|Open-Label Bupropion|"8-weeks of open-label treatment with bupropion following initial randomization phase for individuals who did not remit to treatment with either blinded escitalopram or placebo.~Bupropion XL: Bupropion XL 150-450mg daily"
11220075|NCT02332707|BG000|Baseline|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
11220076|NCT02332707|BG001|Baseline|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
11220077|NCT02332707|BG002|Baseline|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220078|NCT02332707|BG003|Baseline|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220079|NCT02332707|BG004|Baseline|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220080|NCT02332707|BG005|Baseline|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220081|NCT02332707|BG006|Baseline|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220082|NCT02332707|BG007|Baseline|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220083|NCT02332707|BG008|Baseline|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220084|NCT02332707|BG009|Baseline|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220085|NCT02332707|BG010|Baseline|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220086|NCT02332707|BG011|Baseline|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220087|NCT02332707|BG012|Baseline|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220088|NCT02332707|BG013|Baseline|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220089|NCT02332707|BG014|Baseline|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220090|NCT02332707|BG015|Baseline|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
11220091|NCT02332707|BG016|Baseline|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220092|NCT02332707|BG017|Baseline|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220093|NCT02332707|BG018|Baseline|Total|Total of all reporting groups
11220094|NCT02332707|FG000|Participant Flow|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
11220095|NCT02332707|FG001|Participant Flow|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
11220096|NCT02332707|FG002|Participant Flow|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220097|NCT02332707|FG003|Participant Flow|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220098|NCT02332707|FG004|Participant Flow|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220099|NCT02332707|FG005|Participant Flow|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220100|NCT02332707|FG006|Participant Flow|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220101|NCT02332707|FG007|Participant Flow|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220102|NCT02332707|FG008|Participant Flow|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 fixed dose combination (FDC) tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
10836396|NCT00185588|FG001|Participant Flow|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
11220103|NCT02332707|FG009|Participant Flow|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220104|NCT02332707|FG010|Participant Flow|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220105|NCT02332707|FG011|Participant Flow|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220106|NCT02332707|FG012|Participant Flow|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
10836397|NCT00185588|FG002|Participant Flow|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836398|NCT00185588|FG003|Participant Flow|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836399|NCT00185588|OG000|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836400|NCT00185588|OG001|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836401|NCT00185588|OG002|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836402|NCT00185588|OG003|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836403|NCT00185588|EG000|Reported Event|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836404|NCT00185588|EG001|Reported Event|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836405|NCT00185588|EG002|Reported Event|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836406|NCT00185588|EG003|Reported Event|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
10836407|NCT00185614|BG000|Baseline|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
10836408|NCT00185614|FG000|Participant Flow|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
10836409|NCT00185614|OG000|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
10836410|NCT00185614|EG000|Reported Event|All Participants Receviing at Least Auto-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
10836411|NCT00185640|BG000|Baseline|Non-myeloablative Transplantation|Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil
10836412|NCT00185640|FG000|Participant Flow|Non-myeloablative Transplantation|Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil
10836413|NCT00185640|OG000|Outcome|Non-myeloablative Transplantation|Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.
10836414|NCT00185640|EG000|Reported Event|Non-myeloablative Transplantation|
10836415|NCT00185679|BG000|Baseline|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
10836416|NCT00185679|FG000|Participant Flow|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
10836417|NCT00185679|OG000|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
10836418|NCT00185679|EG000|Reported Event|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
10836419|NCT00185692|BG000|Baseline|Transplating of CD34+ Selected Hematopietic Cells|
10836420|NCT00185692|FG000|Participant Flow|Transplating of CD34+ Selected Hematopietic Cells|
10836421|NCT00185692|OG000|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
10836422|NCT00185692|EG000|Reported Event|CD34+ Selected Hematopietic Cells|
10836423|NCT00185731|BG000|Baseline|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
10836424|NCT00185731|FG000|Participant Flow|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
10836425|NCT00185731|OG000|Outcome|Atorvastatin|"Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
10836426|NCT00185731|OG000|Outcome|80 mg|"Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
10836427|NCT00185731|OG000|Outcome|80 mg Atorvastatin|"Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
10836428|NCT00185731|EG000|Reported Event|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
10836429|NCT00185900|BG000|Baseline|Magnesium Sulfate|"Preterm labor treatment with Magnesium Sulfate.~Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician."
10836430|NCT00185900|BG001|Baseline|Nifedipine|"Preterm labor treatment with Nifedipine.~Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours."
10836431|NCT00185900|BG002|Baseline|Total|Total of all reporting groups
10836432|NCT00185900|FG000|Participant Flow|Magnesium Sulfate|"Preterm labor treatment with Magnesium Sulfate.~Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician."
10836433|NCT00185900|FG001|Participant Flow|Nifedipine|"Preterm labor treatment with Nifedipine.~Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours."
10836434|NCT00185900|OG000|Outcome|Magnesium Sulfate|"Preterm labor treatment with Magnesium Sulfate.~Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician."
10836435|NCT00185900|OG001|Outcome|Nifedipine|"Preterm labor treatment with Nifedipine.~Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours."
11220107|NCT02332707|FG013|Participant Flow|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220108|NCT02332707|FG014|Participant Flow|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220109|NCT02332707|FG015|Participant Flow|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
11220110|NCT02332707|FG016|Participant Flow|B6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220111|NCT02332707|FG017|Participant Flow|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220112|NCT02332707|OG000|Outcome|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
11220113|NCT02332707|OG001|Outcome|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
11220114|NCT02332707|OG002|Outcome|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220115|NCT02332707|OG003|Outcome|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220116|NCT02332707|OG004|Outcome|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220117|NCT02332707|OG005|Outcome|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220118|NCT02332707|OG006|Outcome|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220119|NCT02332707|OG007|Outcome|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220120|NCT02332707|OG008|Outcome|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220121|NCT02332707|OG009|Outcome|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220122|NCT02332707|OG010|Outcome|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220123|NCT02332707|OG011|Outcome|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220124|NCT02332707|OG012|Outcome|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220125|NCT02332707|OG013|Outcome|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220126|NCT02332707|OG014|Outcome|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220127|NCT02332707|OG015|Outcome|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220128|NCT02332707|OG016|Outcome|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220129|NCT02332707|OG017|Outcome|16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
11220130|NCT02332707|EG000|Reported Event|A1: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.
11220131|NCT02332707|EG001|Reported Event|A2: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.
11220132|NCT02332707|EG002|Reported Event|A3: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220133|NCT02332707|EG003|Reported Event|A4: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220134|NCT02332707|EG004|Reported Event|A5: GT1 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220135|NCT02332707|EG005|Reported Event|A6: GT1 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220136|NCT02332707|EG006|Reported Event|A7: GT2 NC GZR+UPR+EBR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
11220137|NCT02332707|EG007|Reported Event|A8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
11220138|NCT02332707|EG008|Reported Event|B6: GT1 NC GZR+UPR+RVR (8 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
10836436|NCT00185900|EG000|Reported Event|Magnesium Sulfate|"Preterm labor treatment with Magnesium Sulfate.~Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician."
10836437|NCT00185900|EG001|Reported Event|Nifedipine|"Preterm labor treatment with Nifedipine.~Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours."
10836438|NCT00185965|BG000|Baseline|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836439|NCT00185965|BG001|Baseline|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836440|NCT00185965|BG002|Baseline|Total|Total of all reporting groups
10836441|NCT00185965|FG000|Participant Flow|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836442|NCT00185965|FG001|Participant Flow|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836443|NCT00185965|OG000|Outcome|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836444|NCT00185965|OG001|Outcome|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836445|NCT00185965|EG000|Reported Event|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836446|NCT00185965|EG001|Reported Event|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
10836447|NCT00186017|BG000|Baseline|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
10836448|NCT00186017|BG001|Baseline|Placebo|"Placebo~Olanzapine/Zyprexa"
10836449|NCT00186017|BG002|Baseline|Total|Total of all reporting groups
10836450|NCT00186017|FG000|Participant Flow|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
10836451|NCT00186017|FG001|Participant Flow|Placebo|"Placebo~Olanzapine/Zyprexa"
10836452|NCT00186017|OG000|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
10836453|NCT00186017|OG001|Outcome|Placebo|Placebo up to 8 per day for 1 week
10836454|NCT00186017|OG001|Outcome|Placebo|Placebo
10836455|NCT00186017|EG000|Reported Event|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
10836456|NCT00186017|EG001|Reported Event|Placebo|Placebo taken in same manner as study drug up to 8 per day for 1 week
10836457|NCT00186043|BG000|Baseline|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
10836458|NCT00186043|BG001|Baseline|Placebo|Placebo
10836459|NCT00186043|BG002|Baseline|Total|Total of all reporting groups
10836460|NCT00186043|FG000|Participant Flow|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
10836461|NCT00186043|FG001|Participant Flow|Placebo|Placebo
10836462|NCT00186043|OG000|Outcome|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
10836463|NCT00186043|OG001|Outcome|Placebo|Placebo comparator
10836464|NCT00186043|EG000|Reported Event|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
10836465|NCT00186043|EG001|Reported Event|Placebo|"Placebo~Quetiapine/Seroquel: Quetiapine/Seroquel"
10836466|NCT00186056|BG000|Baseline|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
10836467|NCT00186056|BG001|Baseline|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
10836468|NCT00186056|BG002|Baseline|Total|Total of all reporting groups
10836469|NCT00186056|FG000|Participant Flow|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
11220139|NCT02332707|EG009|Reported Event|B8: GT2 NC GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220140|NCT02332707|EG010|Reported Event|B9: GT1 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220141|NCT02332707|EG011|Reported Event|B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters...|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220142|NCT02332707|EG012|Reported Event|B11: GT2 NC GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220143|NCT02332707|EG013|Reported Event|B12: GT1 C GZR+UPR+RZR (8 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
11220144|NCT02332707|EG014|Reported Event|B13: GT1 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220145|NCT02332707|EG015|Reported Event|B14: GT2 C GZR+UPR+RZR (12 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
11220146|NCT02332707|EG016|Reported Event|B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
11220147|NCT02332707|EG017|Reported Event|B16: GT2 C GZR+UPR+RZR (16 Weeks)|In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
11220148|NCT02332720|BG000|Baseline|A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220149|NCT02332720|BG001|Baseline|A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220150|NCT02332720|BG002|Baseline|A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220151|NCT02332720|BG003|Baseline|A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220152|NCT02332720|BG004|Baseline|B4: GT3 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220153|NCT02332720|BG005|Baseline|B5: GT3 NC TN MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220154|NCT02332720|BG006|Baseline|B6: GT3 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220155|NCT02332720|BG007|Baseline|B7: GT3 NC TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220156|NCT02332720|BG008|Baseline|B8: GT3 NC TE MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220157|NCT02332720|BG009|Baseline|B9: GT3 NC TE MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220158|NCT02332720|BG010|Baseline|B10: GT3 NC TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220159|NCT02332720|BG011|Baseline|B11: GT3 NC TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220160|NCT02332720|BG012|Baseline|B12: GT3 NC TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220161|NCT02332720|BG013|Baseline|B13: GT3 C TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220162|NCT02332720|BG014|Baseline|B14: GT3 C TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220163|NCT02332720|BG015|Baseline|B15: GT3 C TN MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220164|NCT02332720|BG016|Baseline|B16: GT3 C TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
10836470|NCT00186056|FG001|Participant Flow|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
10836471|NCT00186056|OG000|Outcome|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
10836472|NCT00186056|OG001|Outcome|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
10836473|NCT00186056|EG000|Reported Event|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
10836474|NCT00186056|EG001|Reported Event|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
10836475|NCT00186069|BG000|Baseline|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
10836476|NCT00186069|BG001|Baseline|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
10836477|NCT00186069|BG002|Baseline|Total|Total of all reporting groups
10836478|NCT00186069|FG000|Participant Flow|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
10836479|NCT00186069|FG001|Participant Flow|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
10836480|NCT00186069|OG000|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
10836481|NCT00186069|OG001|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
10836482|NCT00186069|EG000|Reported Event|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
10836483|NCT00186069|EG001|Reported Event|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
10836484|NCT00186121|BG000|Baseline|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
10836485|NCT00186121|FG000|Participant Flow|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
10836486|NCT00186121|OG000|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
10836487|NCT00186121|EG000|Reported Event|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
10836488|NCT00186186|BG000|Baseline|Depakote ER|"Depakote ER up to 1500 mg/day~Depakote ER: Depakote ER"
10836489|NCT00186186|FG000|Participant Flow|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
10836490|NCT00186186|OG000|Outcome|Depakote ER|Depakote ER up to 1500 mg/day
10836491|NCT00186186|OG000|Outcome|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
10836492|NCT00186186|EG000|Reported Event|Depakote ER|Depakote ER up to 1500 mg/day
10836493|NCT00186446|BG000|Baseline|Bupropion and Smoking Cessation Behavioral Intervention|
10836494|NCT00186446|FG000|Participant Flow|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
10836495|NCT00186446|OG000|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|
10836496|NCT00186446|OG000|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
10836497|NCT00186446|OG000|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|bupropion and behavioral intervention
10836498|NCT00186446|EG000|Reported Event|Bupropion and Smoking Cessation Behavioral Intervention|
10836499|NCT00186485|BG000|Baseline|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
10836500|NCT00186485|FG000|Participant Flow|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
10836501|NCT00186485|OG000|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
10836502|NCT00186485|EG000|Reported Event|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
10836503|NCT00186498|BG000|Baseline|Memantine|"Patients receive memantine starting the day before ECT begins and while receiving ECT~memantine: Memantine vs placebo"
10836504|NCT00186498|BG001|Baseline|Placebo|"Patients receive placebo starting the day before ECT begins and while receiving ECT~memantine: Memantine vs placebo"
10836505|NCT00186498|BG002|Baseline|Total|Total of all reporting groups
10836506|NCT00186498|FG000|Participant Flow|Memantine|Patients receiving memantine for 2 days before ECT for a total of 30 days
10836507|NCT00186498|FG001|Participant Flow|Placebo|Patients receiving placebo for 2 days before ECT for a total of 30 days
10836508|NCT00186498|OG000|Outcome|Memantine|Patients are randomized 1:1, memantine treatment is for 2 days before ECT for a total of 30 days
10836509|NCT00186498|OG001|Outcome|Placebo|Patients are randomized 1:1, placebo treatment is for 2 days before ECT for a total of 30 days
10836510|NCT00186498|EG000|Reported Event|Memantine|Patients are randomized 1:1, memantine treatment is for 2 days before ECT for a total of 30 days
10836511|NCT00186498|EG001|Reported Event|Placebo|Patients are randomized 1:1, placebo treatment is for 2 days before ECT for a total of 30 days
10836512|NCT00186537|BG000|Baseline|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
10836513|NCT00186537|BG001|Baseline|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
10836514|NCT00186537|BG002|Baseline|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
10836515|NCT00186537|BG003|Baseline|Total|Total of all reporting groups
10836516|NCT00186537|FG000|Participant Flow|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
10836517|NCT00186537|FG001|Participant Flow|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
10836518|NCT00186537|FG002|Participant Flow|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
10836519|NCT00186537|OG000|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
10836520|NCT00186537|OG001|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
10836521|NCT00186537|OG002|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
10836522|NCT00186537|EG000|Reported Event|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
10836523|NCT00186537|EG001|Reported Event|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
10836524|NCT00186537|EG002|Reported Event|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
10836525|NCT00186628|BG000|Baseline|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836526|NCT00186628|FG000|Participant Flow|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836527|NCT00186628|OG000|Outcome|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836528|NCT00186628|OG000|Outcome|Prophylactic Rituximab (CLL Patients)|CLL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836529|NCT00186628|OG001|Outcome|Prophylactic Rituximab (MCL Patients)|MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836530|NCT00186628|EG000|Reported Event|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
10836531|NCT00186875|BG000|Baseline|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
10836532|NCT00186875|BG001|Baseline|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
10836533|NCT00186875|BG002|Baseline|Total|Total of all reporting groups
10836534|NCT00186875|FG000|Participant Flow|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
10836535|NCT00186875|FG001|Participant Flow|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
10836536|NCT00186875|OG000|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
10836537|NCT00186875|OG001|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
10836538|NCT00186875|OG002|Outcome|TOTXV Participants|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. Participants received high-dose methotrexate infusion in upfront window treatment as described in NCT00137111.
10836539|NCT00186875|EG000|Reported Event|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
10836540|NCT00186875|EG001|Reported Event|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
10836541|NCT00186901|BG000|Baseline|Placebo Group|Nutritional counseling + placebo
10836542|NCT00186901|BG001|Baseline|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
10836543|NCT00186901|BG002|Baseline|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
10836544|NCT00186901|BG003|Baseline|Total|Total of all reporting groups
10836545|NCT00186901|FG000|Participant Flow|Placebo Group|Nutritional counseling + placebo
10836546|NCT00186901|FG001|Participant Flow|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
10836547|NCT00186901|FG002|Participant Flow|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
10836548|NCT00186901|OG000|Outcome|Placebo|Placebo Group (Placebo Comparator 1A): Patients who received placebo pills.
10836549|NCT00186901|OG001|Outcome|Supplement|CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation.
10836550|NCT00186901|OG000|Outcome|Male|218 males were eligible for the study
10836551|NCT00186901|OG001|Outcome|Female|206 females were eligible for the study
10836552|NCT00186901|OG000|Outcome|White|365 white patients were eligible for the study
10836553|NCT00186901|OG001|Outcome|Non-white|59 non-white were eligible for the study
10836554|NCT00186901|OG000|Outcome|9 to 13 Years|98 patients between the ages of 9 and 13 were eligible for the study
10836555|NCT00186901|OG001|Outcome|13 to 18 Years|139 patients between the ages of 13 and 18 were eligible for the study
10836556|NCT00186901|OG002|Outcome|18 to 22 Years|74 patients between the ages of 18 and 22 were eligible for the study
10836557|NCT00186901|OG003|Outcome|Above 22 Years|113 patients greater than 22 years of age were eligible for the study
10836558|NCT00186901|OG000|Outcome|Placebo - (QCT)|134 patients were assessed at baseline using the QCT scan.
10836559|NCT00186901|OG001|Outcome|Placebo - (DXA)|60 of the 134 baseline patients also had a DXA scan.
10836560|NCT00186901|OG002|Outcome|Supplement - (QCT)|141 patients were assessed at baseline using the QCT scan.
10836561|NCT00186901|OG003|Outcome|Supplement - (DXA)|61 of the 141 baseline patients also had a DXA scan.
10836562|NCT00186901|OG000|Outcome|Placebo - (QCT)|109 patients were assessed at 12 months using the QCT scan.
10836563|NCT00186901|OG001|Outcome|Placebo - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
10836564|NCT00186901|OG002|Outcome|Supplement - (QCT)|109 patients were assessed at 12 months using the QCT scan.
10836565|NCT00186901|OG003|Outcome|Supplement - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
10836566|NCT00186901|OG000|Outcome|Placebo - (QCT)|91 patients were assessed at 24 months using the QCT scan.
10836567|NCT00186901|OG001|Outcome|Placebo - (DXA)|39 of the 91 patients assessed at 24 months also had a DXA scan.
10836568|NCT00186901|OG002|Outcome|Supplement - (QCT)|97 patients were assessed at 24 months using the QCT scan.
10836569|NCT00186901|OG003|Outcome|Supplement - (DXA)|51 of the 97 patients assessed at 24 months also had a DXA scan.
10836570|NCT00186901|OG000|Outcome|Placebo - (QCT)|84 patients were assessed at 36 months using the QCT scan.
10836571|NCT00186901|OG001|Outcome|Placebo - (DXA)|36 of the 84 patients assessed at 36 months also had a DXA scan.
10836572|NCT00186901|OG002|Outcome|Supplement - (QCT)|96 patients were assessed at 36 months using the QCT scan.
10836573|NCT00186901|OG003|Outcome|Supplement - (DXA)|53 of the 96 patients assessed at 36 months also had a DXA scan.
10836574|NCT00186901|OG000|Outcome|Apa 1 - AA Genotype|The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56.
10836575|NCT00186901|OG001|Outcome|Apa 1 - Aa Genotype|The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44.
10836576|NCT00186901|OG002|Outcome|Apa 1 - aa Genotype|The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57.
10836577|NCT00186901|OG000|Outcome|Bsm - BB Genotype|The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5.
10836578|NCT00186901|OG001|Outcome|Bsm - Bb Genotype|The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17.
10836579|NCT00186901|OG002|Outcome|Bsm - bb Genotype|The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17.
10836580|NCT00186901|EG000|Reported Event|Placebo Group|Nutritional counseling + placebo
10836581|NCT00186901|EG001|Reported Event|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
10836582|NCT00186901|EG002|Reported Event|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
10836583|NCT00187096|BG000|Baseline|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836584|NCT00187096|BG001|Baseline|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836585|NCT00187096|BG002|Baseline|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
11220165|NCT02332720|BG017|Baseline|B17: GT3 C TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220166|NCT02332720|BG018|Baseline|B18: GT3 C TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220167|NCT02332720|BG019|Baseline|B19: GT3 C TE MK-3682B + RBV (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks
11220168|NCT02332720|BG020|Baseline|B20: GT4 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220169|NCT02332720|BG021|Baseline|B21: GT5 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220170|NCT02332720|BG022|Baseline|B22: GT6 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220171|NCT02332720|BG023|Baseline|Total|Total of all reporting groups
11220172|NCT02332720|FG000|Participant Flow|A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220173|NCT02332720|FG001|Participant Flow|A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220174|NCT02332720|FG002|Participant Flow|A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220175|NCT02332720|FG003|Participant Flow|A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220176|NCT02332720|FG004|Participant Flow|B4: GT3 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220177|NCT02332720|FG005|Participant Flow|B5: GT3 NC TN MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220178|NCT02332720|FG006|Participant Flow|B6: GT3 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220179|NCT02332720|FG007|Participant Flow|B7: GT3 NC TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220180|NCT02332720|FG008|Participant Flow|B8: GT3 NC TE MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220181|NCT02332720|FG009|Participant Flow|B9: GT3 NC TE MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220182|NCT02332720|FG010|Participant Flow|B10: GT3 NC TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220183|NCT02332720|FG011|Participant Flow|B11: GT3 NC TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220184|NCT02332720|FG012|Participant Flow|B12: GT3 NC TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220185|NCT02332720|FG013|Participant Flow|B13: GT3 C TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220186|NCT02332720|FG014|Participant Flow|B14: GT3 C TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220187|NCT02332720|FG015|Participant Flow|B15: GT3 C TN MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220188|NCT02332720|FG016|Participant Flow|B16: GT3 C TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
10836586|NCT00187096|BG003|Baseline|Total|Total of all reporting groups
10836587|NCT00187096|FG000|Participant Flow|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|Participants with AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836588|NCT00187096|FG001|Participant Flow|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836589|NCT00187096|FG002|Participant Flow|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
10836590|NCT00187096|OG000|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836591|NCT00187096|OG001|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
10836592|NCT00187096|OG002|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
10836593|NCT00187096|EG000|Reported Event|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
10836594|NCT00187096|EG001|Reported Event|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
10836595|NCT00187096|EG002|Reported Event|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
10836596|NCT00187135|BG000|Baseline|Fentanyl 0.5/Placebo/Fentanyl 1|
10836597|NCT00187135|BG001|Baseline|Fentanyl 0.5/Fentanyl 1/Placebo|
10836598|NCT00187135|BG002|Baseline|Placebo/Fentanyl 0.5/Fentanyl 1|
10836599|NCT00187135|BG003|Baseline|Placebo/Fentanyl 1/Fentanyl 0.5|
10836600|NCT00187135|BG004|Baseline|Fentanyl 1/Fentanyl 0.5/Placebo|
10836601|NCT00187135|BG005|Baseline|Fentanyl 1/Placebo/Fentanyl 0.5|
10836602|NCT00187135|BG006|Baseline|Total|Total of all reporting groups
10836603|NCT00187135|FG000|Participant Flow|Fentanyl 0.5 / Placebo / Fentanyl 1|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
10836604|NCT00187135|FG001|Participant Flow|Fentanyl 0.5 /Fentanyl 1 / Placebo|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
10836605|NCT00187135|FG002|Participant Flow|Placebo / Fentanyl 0.5 /Fentanyl 1|Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
10836606|NCT00187135|FG003|Participant Flow|Placebo /Fentanyl 1 / Fentanyl 0.5|Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
10836607|NCT00187135|FG004|Participant Flow|Fentanyl 1 / Fentanyl 0.5 / Placebo|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
10836608|NCT00187135|FG005|Participant Flow|Fentanyl 1 / Placebo /Fentanyl 0.5|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
10836609|NCT00187135|OG000|Outcome|Fentanyl 1mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
10836610|NCT00187135|OG001|Outcome|Fentanyl 0.5mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
10836611|NCT00187135|OG000|Outcome|Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg|Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.
10836612|NCT00187135|OG000|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
10836613|NCT00187135|OG001|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
10836614|NCT00187135|OG002|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
10836615|NCT00187135|OG002|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
10836616|NCT00187135|EG000|Reported Event|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
10836617|NCT00187135|EG001|Reported Event|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
10836618|NCT00187135|EG002|Reported Event|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
10836619|NCT00187200|BG000|Baseline|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
10836620|NCT00187200|BG001|Baseline|Sequential VV Pacing|V-V delay was optimized
10836621|NCT00187200|BG002|Baseline|Total|Total of all reporting groups
10836622|NCT00187200|FG000|Participant Flow|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
10836623|NCT00187200|FG001|Participant Flow|Sequential VV Pacing|V-V delay was optimized
10836624|NCT00187200|OG000|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay per protocol
10836625|NCT00187200|OG001|Outcome|Sequential VV Pacing|V-V delay was optimized per protocol
10836626|NCT00187200|OG000|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
10836627|NCT00187200|OG001|Outcome|Sequential VV Pacing|V-V delay was optimized
10836628|NCT00187200|EG000|Reported Event|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
10836629|NCT00187200|EG001|Reported Event|Sequential VV Pacing|V-V delay was optimized
10836630|NCT00187278|BG000|Baseline|RV Pacing|"Standard Pacemaker implant~RV Pacing: Standard Pacemaker implant"
10836631|NCT00187278|BG001|Baseline|Biventricular Pacing|"Biventricular Pacemaker implant~Biventricular Pacing: Biventricular Pacemaker implant"
10836632|NCT00187278|BG002|Baseline|Total|Total of all reporting groups
10836633|NCT00187278|FG000|Participant Flow|RV Pacing|"Standard Pacemaker implant~RV Pacing: Standard Pacemaker implant"
10836634|NCT00187278|FG001|Participant Flow|Biventricular Pacing|"Biventricular Pacemaker implant~Biventricular Pacing: Biventricular Pacemaker implant"
10836635|NCT00187278|OG000|Outcome|RV Pacing|"Standard Pacemaker implant~RV Pacing: Standard Pacemaker implant"
10836636|NCT00187278|OG001|Outcome|Biventricular Pacing|"Biventricular Pacemaker implant~Biventricular Pacing: Biventricular Pacemaker implant"
10836637|NCT00187278|OG000|Outcome|RV Pacing|Standard Pacemaker implant
10836638|NCT00187278|OG001|Outcome|Biventricular Pacing|Biventricular Pacemaker implant
10836639|NCT00187278|EG000|Reported Event|RV Pacing|Standard Pacemaker implant
10836640|NCT00187278|EG001|Reported Event|Biventricular Pacing|Biventricular Pacemaker implant
10836641|NCT00187369|BG000|Baseline|Caesarean Section|"delivery by caesarean section~Method of Delivery: CS or VB"
10836642|NCT00187369|BG001|Baseline|Vaginal Birth|"delivery by vaginal birth~Method of Delivery: CS or VB"
10836643|NCT00187369|BG002|Baseline|Total|Total of all reporting groups
10836644|NCT00187369|FG000|Participant Flow|Caesarean Section|"delivery by caesarean section~Method of Delivery: CS or VB"
10836645|NCT00187369|FG001|Participant Flow|Vaginal Birth|"delivery by vaginal birth~Method of Delivery: CS or VB"
10836646|NCT00187369|OG000|Outcome|Planned Caesarean Section|delivery by CS or Method of Delivery: CS or VB
10836647|NCT00187369|OG001|Outcome|Planned Vaginal Birth|delivery by VB or Method of Delivery: CS or VB
10836648|NCT00187369|OG000|Outcome|Planned Caesarean Section|"delivery by caesarean section~Method of Delivery: CS or VB"
10836649|NCT00187369|OG001|Outcome|Planned Vaginal Birth|"delivery by vaginal birth~Method of Delivery: CS or VB"
10836650|NCT00187369|OG000|Outcome|Planned Caesarean Section|"delivery by CS~Method of Delivery: CS or VB"
10836651|NCT00187369|OG001|Outcome|Planned Vaginal Birth|"delivery by VB~Method of Delivery: CS or VB"
10836652|NCT00187369|EG000|Reported Event|Planned Caesarean Section-Mother|delivery by CS or Method of Delivery: CS or VB
10836653|NCT00187369|EG001|Reported Event|Planned Vaginal Birth-Mother|delivery by VB or Method of Delivery: CS or VB
10836654|NCT00187369|EG002|Reported Event|Planned Caesarean Section-Infants/Fetuses|delivery by CS or Method of Delivery: CS or VB
10836655|NCT00187369|EG003|Reported Event|Planned Vaginal Birth-Infants/Fetuses|delivery by VB or Method of Delivery: CS or VB
10836656|NCT00187486|BG000|Baseline|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
10836657|NCT00187486|FG000|Participant Flow|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
10836658|NCT00187486|OG000|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
10836659|NCT00187486|EG000|Reported Event|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
10836660|NCT00187655|BG000|Baseline|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
10836661|NCT00187655|FG000|Participant Flow|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
10836662|NCT00187655|OG000|Outcome|Heterozygous for the Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
10836663|NCT00187655|OG001|Outcome|Homozygous for OAT3-Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
10836664|NCT00187655|EG000|Reported Event|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
10836665|NCT00187681|BG000|Baseline|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
10836666|NCT00187681|BG001|Baseline|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
10836667|NCT00187681|BG002|Baseline|Total|Total of all reporting groups
10836668|NCT00187681|FG000|Participant Flow|Organic Cation Transporter 1 (OCT1)-Variant Group|Subjects with OCT1-variant alleles to be dosed with 2 doses of Metformin (total 1850 mg).
10836669|NCT00187681|FG001|Participant Flow|Organic Cation Transporter 1 (OCT1)-Reference Group|Subjects with OCT1-reference alleles to be dosed with 2 doses of Metformin (total 1850 mg).
10836670|NCT00187681|OG000|Outcome|OCT1-variant Group|Metformin blood concentration-time profiles in subjects carrying the variant OCT1 genotypes (ie. carries at least one of the four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
10836671|NCT00187681|OG001|Outcome|OCT1-reference Group|Metformin blood concentration-time profiles in subjects carrying the reference OCT1 allele at all the four positions in the OCT1 gene.
10836672|NCT00187681|OG000|Outcome|OCT1-variant Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying variant OCT1 genotypes (ie. carries at least one of four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
10836673|NCT00187681|OG001|Outcome|OCT1-reference Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying the reference OCT1 genotype at all the four positions in the OCT1 gene.
10836674|NCT00187681|EG000|Reported Event|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
10836675|NCT00187681|EG001|Reported Event|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
10836676|NCT00187720|BG000|Baseline|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
10836677|NCT00187720|BG001|Baseline|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
10836678|NCT00187720|BG002|Baseline|Total|Total of all reporting groups
10836679|NCT00187720|FG000|Participant Flow|Organic Cation Transporter 2 (OCT2)-Variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
10836680|NCT00187720|FG001|Participant Flow|Organic Cation Transporter 2 (OCT2)-Reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
10836681|NCT00187720|OG000|Outcome|OCT2-variant Group|The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, *3D) following a single oral dose of 850 mg of metformin.
10836682|NCT00187720|OG001|Outcome|OCT2-reference Group|The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
10836683|NCT00187720|EG000|Reported Event|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
10836684|NCT00187720|EG001|Reported Event|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
11220189|NCT02332720|FG017|Participant Flow|B17: GT3 C TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
10836685|NCT00187876|BG000|Baseline|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
10836686|NCT00187876|BG001|Baseline|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
10836687|NCT00187876|BG002|Baseline|Total|Total of all reporting groups
10836688|NCT00187876|FG000|Participant Flow|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts."
10836689|NCT00187876|FG001|Participant Flow|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
10836690|NCT00187876|OG000|Outcome|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
10836691|NCT00187876|OG001|Outcome|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
11220190|NCT02332720|FG018|Participant Flow|B18: GT3 C TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220191|NCT02332720|FG019|Participant Flow|B19: GT3 C TE MK-3682B + RBV (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
11220192|NCT02332720|FG020|Participant Flow|B20: GT4 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220193|NCT02332720|FG021|Participant Flow|B21: GT5 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220194|NCT02332720|FG022|Participant Flow|B22: GT6 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220195|NCT02332720|OG000|Outcome|A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
11220196|NCT02332720|OG001|Outcome|A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.
11220197|NCT02332720|OG002|Outcome|A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
11220198|NCT02332720|OG003|Outcome|A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.
11220199|NCT02332720|OG004|Outcome|A4+B4: GT3 NC TN MK-3682B (8 Weeks)|HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.
11220200|NCT02332720|OG005|Outcome|B4: GT3 NC TN MK-3682B (8 Weeks)|HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B
11220201|NCT02332720|OG006|Outcome|B5: GT3 NC TN MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220202|NCT02332720|OG007|Outcome|B6: GT3 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220203|NCT02332720|OG008|Outcome|B7: GT3 NC TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220204|NCT02332720|OG009|Outcome|B8: GT3 NC TE MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220205|NCT02332720|OG010|Outcome|B9: GT3 NC TE MK-3682B + RBV (8 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220206|NCT02332720|OG011|Outcome|B10: GT3 NC TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220207|NCT02332720|OG012|Outcome|B11: GT3 NC TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220208|NCT02332720|OG013|Outcome|B12: GT3 NC TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220209|NCT02332720|OG014|Outcome|B13: GT3 C TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220210|NCT02332720|OG015|Outcome|B14: GT3 C TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220211|NCT02332720|OG016|Outcome|B15: GT3 C TN MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220212|NCT02332720|OG017|Outcome|B16: GT3 C TE MK-3682B (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220213|NCT02332720|OG018|Outcome|B17: GT3 C TE MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220214|NCT02332720|OG019|Outcome|B18: GT3 C TE MK-3682B (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220215|NCT02332720|OG020|Outcome|B19: GT3 C TE MK-3682B + RBV (16 Weeks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
11220216|NCT02332720|OG000|Outcome|A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220217|NCT02332720|OG001|Outcome|A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220218|NCT02332720|OG002|Outcome|A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220219|NCT02332720|OG003|Outcome|A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)|In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220220|NCT02332720|OG004|Outcome|A4+ B4: GT3 NC TN MK-3682B (8 Weeks)|HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.
11220221|NCT02332720|OG005|Outcome|B4: GT3 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks
11220222|NCT02332720|OG007|Outcome|B6: GT3 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks
11220223|NCT02332720|OG008|Outcome|B7: GT3 NC TN MK-3682B + RBV (12 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks
11220224|NCT02332720|OG021|Outcome|B20: GT4 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220225|NCT02332720|OG022|Outcome|B22: GT6 NC TN MK-3682B (12 Weeks)|In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220226|NCT02332720|OG023|Outcome|Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)|Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
11220227|NCT02332720|OG004|Outcome|A4+B4: GT3 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220228|NCT02332720|OG005|Outcome|B4: GT3 NC TN MK-3682B (8 Weeks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220229|NCT02332720|EG000|Reported Event|A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
11220230|NCT02332720|EG001|Reported Event|A1+C: GT3 NC TN EBR+GZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir 300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
11220231|NCT02332720|EG002|Reported Event|A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.
11220232|NCT02332720|EG003|Reported Event|A2+C: GT3 NC TN GZR+RZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
11220233|NCT02332720|EG004|Reported Event|A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
11220234|NCT02332720|EG005|Reported Event|A3+C: GT3 NC TN EBR+GZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)|In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
11220235|NCT02332720|EG006|Reported Event|A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)|In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.
11220236|NCT02332720|EG007|Reported Event|A4+C: GT3 NC TN GZR+RZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)|In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
11220237|NCT02332720|EG008|Reported Event|B4: GT3 NC TN MK-3682B (8 Wks)|In Part B, participants received 2 MK- 3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220238|NCT02332720|EG009|Reported Event|B5: GT3 NC TN MK-3682B + RBV (8 Wks)|In Part B , participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220239|NCT02332720|EG010|Reported Event|B6: GT3 NC TN MK-3682B (12 Wks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220240|NCT02332720|EG011|Reported Event|B7: GT3 NC TN MK-3682B + RBV (12 Wks)|In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220241|NCT02332720|EG012|Reported Event|B8: GT3 NC TE MK-3682B (8 Wks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220242|NCT02332720|EG013|Reported Event|B9: GT3 NC TE MK-3682B + RBV (8 Wks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
11220243|NCT02332720|EG014|Reported Event|B10: GT3 NC TE MK-3682B (12 Wks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220244|NCT02332720|EG015|Reported Event|B11: GT3 NC TE MK-3682B + RBV (12 Wks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220245|NCT02332720|EG016|Reported Event|B12: GT3 NC TE MK-3682B (16 Wks)|In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220246|NCT02332720|EG017|Reported Event|B13: GT3 C TN MK-3682B (12 Wks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220247|NCT02332720|EG018|Reported Event|B14: GT3 C TN MK-3682B + RBV (12 Wks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220248|NCT02332720|EG019|Reported Event|B15: GT3 C TN MK-3682B (16 Wks)|In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220249|NCT02332720|EG020|Reported Event|B16: GT3 C TE MK-3682B (12 Wks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220250|NCT02332720|EG021|Reported Event|B17: GT3 C TE MK-3682B + RBV (12 Wks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
11220251|NCT02332720|EG022|Reported Event|B18: GT3 C TE MK-3682B (16 Wks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
11220252|NCT02332720|EG023|Reported Event|B19: GT3 C TE MK-3682B + RBV (16 Wks)|In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
11220253|NCT02332720|EG024|Reported Event|B20: GT4 NC TN MK-3682B (8 Wks)|In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
11220254|NCT02332720|EG025|Reported Event|B22: GT6 NC TN MK-3682B (12 Wks)|In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
11220255|NCT02332798|BG000|Baseline|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220256|NCT02332798|BG001|Baseline|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220257|NCT02332798|BG002|Baseline|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220258|NCT02332798|BG003|Baseline|Total|Total of all reporting groups
11220259|NCT02332798|FG000|Participant Flow|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220260|NCT02332798|FG001|Participant Flow|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220261|NCT02332798|FG002|Participant Flow|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220262|NCT02332798|OG000|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220263|NCT02332798|OG001|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220264|NCT02332798|OG002|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220265|NCT02332798|EG000|Reported Event|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220266|NCT02332798|EG001|Reported Event|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220267|NCT02332798|EG002|Reported Event|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11220268|NCT02332824|BG000|Baseline|Placebo|TAK-272 placebo, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220269|NCT02332824|BG001|Baseline|TAK-272 5 mg|TAK-272 5 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220270|NCT02332824|BG002|Baseline|TAK-272 20 mg|TAK-272 20 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220271|NCT02332824|BG003|Baseline|TAK-272 40 mg|TAK-272 20 mg, 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220272|NCT02332824|BG004|Baseline|TAK-272 80 mg|TAK-272 20 mg, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220273|NCT02332824|BG005|Baseline|Candesartan Cilexetil 8 mg|Candesartan cilexetil 8 mg, one tablet, and TAK-272 placebo 4 tablets, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220274|NCT02332824|BG006|Baseline|Total|Total of all reporting groups
11220275|NCT02332824|FG000|Participant Flow|Placebo|TAK-272 placebo, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220276|NCT02332824|FG001|Participant Flow|TAK-272 5 mg|TAK-272 5 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
10836692|NCT00187876|EG000|Reported Event|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using asceptic patellar tendon allografts."
10836693|NCT00187876|EG001|Reported Event|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
10836694|NCT00187889|BG000|Baseline|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
10836695|NCT00187889|BG001|Baseline|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
10836696|NCT00187889|BG002|Baseline|Total|Total of all reporting groups
10836697|NCT00187889|FG000|Participant Flow|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
10836698|NCT00187889|FG001|Participant Flow|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
10836699|NCT00187889|OG000|Outcome|EPLERINONE|Active drug
10836700|NCT00187889|OG001|Outcome|PLACEBO|Inert Placebo
10836701|NCT00187889|OG000|Outcome|EPLERENONE|Active Drug
10836702|NCT00187889|EG000|Reported Event|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
10836703|NCT00187889|EG001|Reported Event|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
10836704|NCT00189098|BG000|Baseline|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
10836705|NCT00189098|BG001|Baseline|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
10836706|NCT00189098|BG002|Baseline|Total|Total of all reporting groups
10836707|NCT00189098|FG000|Participant Flow|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
10836708|NCT00189098|FG001|Participant Flow|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
10836709|NCT00189098|OG000|Outcome|Sulfamethoxazole-trimethoprim|The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.
10836710|NCT00189098|OG001|Outcome|Placebo|The children in this group received placebo orally two times a day for 6 to 12 weeks.
10836711|NCT00189098|OG000|Outcome|Sulfamethoxazole-trimethoprim|
10836712|NCT00189098|OG001|Outcome|Placebo|
10836713|NCT00189098|EG000|Reported Event|Sulfamethoxazole-trimethoprim|
10836714|NCT00189098|EG001|Reported Event|Placebo|
10836715|NCT00189137|BG000|Baseline|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836716|NCT00189137|BG001|Baseline|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836717|NCT00189137|BG002|Baseline|Total|Total of all reporting groups
10836718|NCT00189137|FG000|Participant Flow|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836719|NCT00189137|FG001|Participant Flow|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836720|NCT00189137|OG000|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836721|NCT00189137|OG001|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836722|NCT00189137|EG000|Reported Event|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836723|NCT00189137|EG001|Reported Event|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
10836724|NCT00189202|BG000|Baseline|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
10836725|NCT00189202|FG000|Participant Flow|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
10836726|NCT00189202|OG000|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
10836727|NCT00189202|EG000|Reported Event|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
10836728|NCT00189228|BG000|Baseline|Xolair|This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
10836729|NCT00189228|FG000|Participant Flow|Xolair|This is not a drug study examining differences of therapeutic outcomes. This is an open label, non randomized single dose level study in which patients will be treated for 85 days with rhuMAB-E25 (Xolair) and followed for a total of 300 days. The dose of Xolair is determined by the patient's total serum IgE and body weight and is administered subcutaneously every 2 or 4 weeks. Outcome is serum anti-KLH antibody (immunoglobulin classes).
10836730|NCT00189228|OG000|Outcome|Xolair|This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
10836731|NCT00189228|EG000|Reported Event|Xolair|This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
10836732|NCT00189306|BG000|Baseline|Aldara|Aldara (imiquimod) cream 5%
10836733|NCT00189306|FG000|Participant Flow|Aldara|Aldara (imiquimod) cream 5%
10836734|NCT00189306|OG000|Outcome|Aldara|Aldara (imiquimod) cream 5%
10836735|NCT00189306|EG000|Reported Event|Aldara|Aldara (imiquimod) cream 5%
10836736|NCT00189423|BG000|Baseline|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
10836737|NCT00189423|BG001|Baseline|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
10836738|NCT00189423|BG002|Baseline|Total|Total of all reporting groups
10836739|NCT00189423|FG000|Participant Flow|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
10836740|NCT00189423|FG001|Participant Flow|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
10836741|NCT00189423|OG000|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
10836742|NCT00189423|OG001|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
10836743|NCT00189423|EG000|Reported Event|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
10836744|NCT00189423|EG001|Reported Event|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
10836745|NCT00189436|BG000|Baseline|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
10836746|NCT00189436|BG001|Baseline|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
10836747|NCT00189436|BG002|Baseline|Total|Total of all reporting groups
10836748|NCT00189436|FG000|Participant Flow|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
10836749|NCT00189436|FG001|Participant Flow|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
10836750|NCT00189436|OG000|Outcome|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
10836751|NCT00189436|OG001|Outcome|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
10836752|NCT00189436|EG000|Reported Event|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
10836753|NCT00189436|EG001|Reported Event|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
10836754|NCT00189462|BG000|Baseline|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
10836755|NCT00189462|BG001|Baseline|Placebo|Treatment with placebo for 4 months
10836756|NCT00189462|BG002|Baseline|Total|Total of all reporting groups
10836757|NCT00189462|FG000|Participant Flow|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
10836758|NCT00189462|FG001|Participant Flow|Placebo|Treatment with placebo for 4 months
10836759|NCT00189462|OG000|Outcome|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
10836760|NCT00189462|OG001|Outcome|Placebo|Treatment with placebo for 4 months
10836761|NCT00189462|EG000|Reported Event|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
10836762|NCT00189462|EG001|Reported Event|Placebo|Treatment with placebo for 4 months
10836763|NCT00189475|BG000|Baseline|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
10836764|NCT00189475|BG001|Baseline|Placebo|Treated for 4 months with placebo
10836765|NCT00189475|BG002|Baseline|Total|Total of all reporting groups
10836766|NCT00189475|FG000|Participant Flow|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
10836767|NCT00189475|FG001|Participant Flow|Placebo|Treated for 4 months with placebo
10836768|NCT00189475|OG000|Outcome|Montelukast|Montelukast 10mg per day for 6 days
10836769|NCT00189475|OG001|Outcome|Placebo|Treated for 6 days with placebo
10836770|NCT00189475|EG000|Reported Event|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
10836771|NCT00189475|EG001|Reported Event|Placebo|Treated for 4 months with placebo
10836772|NCT00189488|BG000|Baseline|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
10836773|NCT00189488|BG001|Baseline|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
10836774|NCT00189488|BG002|Baseline|Total|Total of all reporting groups
10836775|NCT00189488|FG000|Participant Flow|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.
10836776|NCT00189488|FG001|Participant Flow|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively
10836777|NCT00189488|OG000|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
10836778|NCT00189488|OG001|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
10836779|NCT00189488|OG001|Outcome|Palifermin|PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
10836780|NCT00189488|EG000|Reported Event|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
11220277|NCT02332824|FG002|Participant Flow|TAK-272 20 mg|TAK-272 20 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220278|NCT02332824|FG003|Participant Flow|TAK-272 40 mg|TAK-272 20 mg, 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220279|NCT02332824|FG004|Participant Flow|TAK-272 80 mg|TAK-272 20 mg, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220280|NCT02332824|FG005|Participant Flow|Candesartan Cilexetil 8 mg|Candesartan cilexetil 8 mg, one tablet, and TAK-272 placebo 4 tablets, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220281|NCT02332824|OG000|Outcome|Placebo|TAK-272 placebo, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220282|NCT02332824|OG001|Outcome|TAK-272 5 mg|TAK-272 5 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220283|NCT02332824|OG002|Outcome|TAK-272 20 mg|TAK-272 20 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220284|NCT02332824|OG003|Outcome|TAK-272 40 mg|TAK-272 20 mg, 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220285|NCT02332824|OG004|Outcome|TAK-272 80 mg|TAK-272 20 mg, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220286|NCT02332824|OG005|Outcome|Candesartan Cilexetil 8 mg|Candesartan cilexetil 8 mg, one tablet, and TAK-272 placebo 4 tablets, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220287|NCT02332824|EG000|Reported Event|Placebo|TAK-272 placebo, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220288|NCT02332824|EG001|Reported Event|TAK-272 5 mg|TAK-272 5 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220289|NCT02332824|EG002|Reported Event|TAK-272 20 mg|TAK-272 20 mg, one tablet, TAK-272 placebo 3 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220290|NCT02332824|EG003|Reported Event|TAK-272 40 mg|TAK-272 20 mg, 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220291|NCT02332824|EG004|Reported Event|TAK-272 80 mg|TAK-272 20 mg, 4 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220292|NCT02332824|EG005|Reported Event|Candesartan Cilexetil 8 mg|Candesartan cilexetil 8 mg, one tablet, and TAK-272 placebo 4 tablets, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).
11220293|NCT02332863|BG000|Baseline|Back-loaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.~Back-loaded Needle (Device): Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220294|NCT02332863|BG001|Baseline|Preloaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.~Preloaded Needle (Device): Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220295|NCT02332863|BG002|Baseline|Total|Total of all reporting groups
11220296|NCT02332863|FG000|Participant Flow|Back-loaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.~Back-loaded Needle (Device): Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220297|NCT02332863|FG001|Participant Flow|Preloaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.~Preloaded Needle (Device): Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220298|NCT02332863|OG000|Outcome|Back-loaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.~Back-loaded Needle (Device): Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220299|NCT02332863|OG001|Outcome|Preloaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.~Preloaded Needle (Device): Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220300|NCT02332863|EG000|Reported Event|Back-loaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.~Back-loaded Needle (Device): Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220301|NCT02332863|EG001|Reported Event|Preloaded Needle|"The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.~Preloaded Needle (Device): Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:~total length of procedure~how many markers are successfully deployed~technical success~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
11220302|NCT02332876|BG000|Baseline|Exercise Intervention|"This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.~Exercise"
11220303|NCT02332876|BG001|Baseline|Wellness Waitlist Control|"This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.~Control"
11220304|NCT02332876|BG002|Baseline|Total|Total of all reporting groups
11220305|NCT02332876|FG000|Participant Flow|Exercise Intervention|"This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.~Exercise"
11220306|NCT02332876|FG001|Participant Flow|Wellness Waitlist Control|"This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.~Control"
11220307|NCT02332876|OG000|Outcome|Exercise Intervention|"This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.~Exercise"
11220308|NCT02332876|OG001|Outcome|Wellness Waitlist Control|"This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.~Control"
11220309|NCT02332876|EG000|Reported Event|Exercise Intervention|"This arm will receive a 12-week individually tailored phone and email-based exercise program.~Exercise"
11220310|NCT02332876|EG001|Reported Event|Wellness Waitlist Control|"This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.~Control"
11220311|NCT02332889|BG000|Baseline|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
11220312|NCT02332889|FG000|Participant Flow|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells [DC]): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive 5-aza-2-deoxycytidine (DAC) at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
11220313|NCT02332889|OG000|Outcome|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
11220314|NCT02332889|EG000|Reported Event|Decitabine/Vaccine Therapy|"Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol~Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination~Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine"
11220315|NCT02332902|BG000|Baseline|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
11220316|NCT02332902|FG000|Participant Flow|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
11220317|NCT02332902|OG000|Outcome|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
11220318|NCT02332902|EG000|Reported Event|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
11220319|NCT02332915|BG000|Baseline|SPT - Intense First|"Participants received intense application in the first phase of treatment, followed by the non intense application of treatment.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.~Intense application = SPT-I: treatment administered for 3 hourly sessions per day, 3 days per week, for 3 weeks for a total of 27 hourly sessions."
11220320|NCT02332915|BG001|Baseline|SPT - Traditional First|"Participants received non intense, traditional application of treatment in the first phase of treatment, followed by the intense application of treatment.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.~Traditional application = SPT-T: treatment administered for 1 hourly session, 3 days per week for 9 weeks for a total of 27 hourly sessions."
11220321|NCT02332915|BG002|Baseline|Total|Total of all reporting groups
11220322|NCT02332915|FG000|Participant Flow|SPT - Intense First|"Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220323|NCT02332915|FG001|Participant Flow|SPT - Traditional First|"Participants will receive non intense, traditional application of treatment in the first phase of treatment, followed by the intense application of treatment.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220324|NCT02332915|OG000|Outcome|SPT - Intense: All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220325|NCT02332915|OG001|Outcome|SPT - Traditional (Non-intense): All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220326|NCT02332915|OG000|Outcome|SPT - Intense; All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
10836781|NCT00189488|EG001|Reported Event|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
10836782|NCT00189540|BG000|Baseline|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
10836783|NCT00189540|BG001|Baseline|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
10836784|NCT00189540|BG002|Baseline|Total|Total of all reporting groups
10836785|NCT00189540|FG000|Participant Flow|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
10836786|NCT00189540|FG001|Participant Flow|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
10836787|NCT00189540|OG000|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
10836788|NCT00189540|OG001|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
10836789|NCT00189540|EG000|Reported Event|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
10836790|NCT00189540|EG001|Reported Event|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
10836791|NCT00190671|BG000|Baseline|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836792|NCT00190671|BG001|Baseline|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836793|NCT00190671|BG002|Baseline|Total|Total of all reporting groups
10836794|NCT00190671|FG000|Participant Flow|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836795|NCT00190671|FG001|Participant Flow|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836796|NCT00190671|OG000|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836797|NCT00190671|OG001|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836798|NCT00190671|OG000|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836799|NCT00190671|EG000|Reported Event|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836800|NCT00190671|EG001|Reported Event|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
10836801|NCT00190684|BG000|Baseline|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
10836802|NCT00190684|FG000|Participant Flow|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
10836803|NCT00190684|OG000|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
10836804|NCT00190684|EG000|Reported Event|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
10836805|NCT00190749|BG000|Baseline|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
10836806|NCT00190749|BG001|Baseline|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
10836807|NCT00190749|BG002|Baseline|Total|Total of all reporting groups
10836808|NCT00190749|FG000|Participant Flow|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
10836809|NCT00190749|FG001|Participant Flow|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
10836810|NCT00190749|OG000|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
10836811|NCT00190749|OG001|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
10836812|NCT00190749|EG000|Reported Event|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
10836813|NCT00190749|EG001|Reported Event|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
10836814|NCT00190775|BG000|Baseline|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
10836815|NCT00190775|BG001|Baseline|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
10836816|NCT00190775|BG002|Baseline|Total|Total of all reporting groups
10836817|NCT00190775|FG000|Participant Flow|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
10836818|NCT00190775|FG001|Participant Flow|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
10836819|NCT00190775|OG000|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
10836820|NCT00190775|OG001|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
10836821|NCT00190775|OG000|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 4 days
10836822|NCT00190775|OG001|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
10836823|NCT00190775|OG002|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
10836824|NCT00190775|OG000|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
10836825|NCT00190775|OG000|Outcome|Placebo/Atomoxetine Group 1|Placebo for 24 Weeks followed by atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
10836826|NCT00190775|OG001|Outcome|Placebo/Atomoxetine Group 2|Placebo for 24 weeks followed by atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
10836827|NCT00190775|OG002|Outcome|Atomoxetine|Atomoxetine for 24 weeks
10836828|NCT00190775|EG000|Reported Event|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
10836829|NCT00190775|EG001|Reported Event|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
10836830|NCT00190983|BG000|Baseline|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
10836831|NCT00190983|FG000|Participant Flow|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
10836832|NCT00190983|OG000|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
10836833|NCT00190983|EG000|Reported Event|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
10836834|NCT00191100|BG000|Baseline|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
10836835|NCT00191100|BG001|Baseline|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
10836836|NCT00191100|BG002|Baseline|Total|Total of all reporting groups
10836837|NCT00191100|FG000|Participant Flow|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
10836838|NCT00191100|FG001|Participant Flow|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
10836839|NCT00191100|OG000|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
10836840|NCT00191100|OG001|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
10836841|NCT00191100|EG000|Reported Event|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
10836842|NCT00191100|EG001|Reported Event|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
10836843|NCT00191113|BG000|Baseline|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
10836844|NCT00191113|BG001|Baseline|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
10836845|NCT00191113|BG002|Baseline|Total|Total of all reporting groups
10836846|NCT00191113|FG000|Participant Flow|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
10836847|NCT00191113|FG001|Participant Flow|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
11220327|NCT02332915|OG001|Outcome|SPT - Traditional; All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT- Intense; SPT- I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220328|NCT02332915|EG000|Reported Event|SPT - Intense: All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220329|NCT02332915|EG001|Reported Event|SPT - Traditional (Non-intense): All Participants|"All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional.~Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy."
11220330|NCT02333045|BG000|Baseline|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
11220331|NCT02333045|BG001|Baseline|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
11220332|NCT02333045|BG002|Baseline|Total|Total of all reporting groups
11220333|NCT02333045|FG000|Participant Flow|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
11220334|NCT02333045|FG001|Participant Flow|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
11220335|NCT02333045|OG000|Outcome|Truvada|Women randomized to receive one tablet of Truvada (200mg emtricitabine/300mg tenofovir) daily for 7 days.
11220336|NCT02333045|OG001|Outcome|Maraviroc|Women randomized to receive 300mg of Maraviroc daily for 7 days.
11220337|NCT02333045|EG000|Reported Event|Truvada|Women randomized to receive on tablet of Truvada daily for 7 days.
11220338|NCT02333045|EG001|Reported Event|Maraviroc|Women randomized to receive 300mg of Maraviroc 300 mg daily for 7 days.
11220339|NCT02333071|BG000|Baseline|Bremelanotide (BMT/BMT)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE)~BMT/BMT~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220340|NCT02333071|BG001|Baseline|Placebo (PBO/BMT)|"Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo~PBO/BMT~Placebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220341|NCT02333071|BG002|Baseline|Total|Total of all reporting groups
11220342|NCT02333071|FG000|Participant Flow|Placebo PBO/BMT|"Core Study: Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.~Placebo~OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220343|NCT02333071|FG001|Participant Flow|Bremelanotide BMT/BMT|"Core and OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220344|NCT02333071|OG000|Outcome|Bremelanotide BMT/BMT|"(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks~(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220345|NCT02333071|OG001|Outcome|Placebo PBO/BMT|"(Main Study) PBO administered SC on an as-desired basis for 24 weeks~Placebo: Placebo~(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks~Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220346|NCT02333071|OG000|Outcome|Bremelanotide BMT|"(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
10836848|NCT00191113|OG000|Outcome|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
10836849|NCT00191113|OG001|Outcome|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
10836850|NCT00191113|OG000|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
10836851|NCT00191113|OG001|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
10836852|NCT00191113|OG001|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
10836853|NCT00191113|OG000|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
10836854|NCT00191113|OG001|Outcome|Treated-As-Randomized Humatrope|Patients in As-Randomized Humatrope group who received Humatrope treatment
10836855|NCT00191113|OG001|Outcome|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
10836856|NCT00191113|EG000|Reported Event|Treated-As-Randomized Control|Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.
10836857|NCT00191113|EG001|Reported Event|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
10836858|NCT00191139|BG000|Baseline|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
10836859|NCT00191139|BG001|Baseline|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
10836860|NCT00191139|BG002|Baseline|Total|Total of all reporting groups
10836861|NCT00191139|FG000|Participant Flow|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
10836862|NCT00191139|FG001|Participant Flow|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
10836863|NCT00191139|OG000|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
10836864|NCT00191139|OG001|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
10836865|NCT00191139|EG000|Reported Event|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
10836866|NCT00191139|EG001|Reported Event|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
10836867|NCT00191152|BG000|Baseline|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued."
10836868|NCT00191152|BG001|Baseline|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
10836869|NCT00191152|BG002|Baseline|Total|Total of all reporting groups
10836870|NCT00191152|FG000|Participant Flow|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline."
10836871|NCT00191152|FG001|Participant Flow|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
10836872|NCT00191152|OG000|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
10836873|NCT00191152|OG001|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
11220347|NCT02333071|OG001|Outcome|Placebo PBO|"(Main Study) PBO administered SC on an as-desired basis for 24 weeks~Placebo: Placebo"
11220348|NCT02333071|OG001|Outcome|Placebo PBO|"Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Placebo: Placebo"
11220349|NCT02333071|EG000|Reported Event|Bremelanotide (Main Study)|"Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220350|NCT02333071|EG001|Reported Event|Placebo (Main Study)|"Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.~Placebo: Placebo"
11220351|NCT02333071|EG002|Reported Event|Bremelanotide (OLE)|"Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220352|NCT02333071|EG003|Reported Event|Placebo (OLE)|"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours f or 52 weeks.~bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"
11220353|NCT02333331|BG000|Baseline|BYM338 70 mg|BYM338 70 mg intravenous infusion
11220354|NCT02333331|BG001|Baseline|BYM338 210 mg|BYM338 210 mg intravenous infusion
11220355|NCT02333331|BG002|Baseline|BYM338 700 mg|BYM338 700 mg intravenous infusion
11220356|NCT02333331|BG003|Baseline|Placebo|Placebo intravenous infusion
11220357|NCT02333331|BG004|Baseline|Total|Total of all reporting groups
11220358|NCT02333331|FG000|Participant Flow|BYM338 70 mg|BYM338 70 mg intravenous infusion
11220359|NCT02333331|FG001|Participant Flow|BYM338 210 mg|BYM338 210 mg intravenous infusion
11220360|NCT02333331|FG002|Participant Flow|BYM338 700 mg|BYM338 700 mg intravenous infusion
11220361|NCT02333331|FG003|Participant Flow|Placebo|Placebo intravenous infusion
11220362|NCT02333331|OG000|Outcome|BYM338 70 mg|BYM338 70 mg intravenous infusion
11220363|NCT02333331|OG001|Outcome|BYM338 210 mg|BYM338 210 mg intravenous infusion
11220364|NCT02333331|OG002|Outcome|BYM338 700 mg|BYM338 700 mg intravenous infusion
11220365|NCT02333331|OG003|Outcome|Placebo|Placebo intravenous infusion
11220366|NCT02333331|EG000|Reported Event|BYM338 70 mg|BYM338 70 mg intravenous infusion
11220367|NCT02333331|EG001|Reported Event|BYM338 210 mg|BYM338 210 mg intravenous infusion
11220368|NCT02333331|EG002|Reported Event|BYM338 700 mg|BYM338 700 mg intravenous infusion
11220369|NCT02333331|EG003|Reported Event|Placebo|Placebo intravenous infusion
11220370|NCT02333383|BG000|Baseline|Participants With Ankylosing Spondylitis|Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
11220371|NCT02333383|FG000|Participant Flow|Participants With Ankylosing Spondylitis|Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
11220372|NCT02333383|OG000|Outcome|Participants With Ankylosing Spondylitis|Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
11220373|NCT02333383|EG000|Reported Event|Participants With Ankylosing Spondylitis|Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
11220374|NCT02333487|BG000|Baseline|Lu AF35700 (Group D1)|"Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).~D1 receptor occupancy measured using [11C]-NNC 112."
11220375|NCT02333487|BG001|Baseline|Lu AF35700 (Group D2)|"Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days).~D2 receptor occupancy measured using [11C]-raclopride."
11220376|NCT02333487|BG002|Baseline|Lu AF35700 (Group 5-HT6)|"Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7).~5-HT6 receptor occupancy measured using [11C]-Lu AE60157."
11220377|NCT02333487|BG003|Baseline|Total|Total of all reporting groups
11220378|NCT02333487|FG000|Participant Flow|Lu AF35700 (Group D1)|"Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).~D1 receptor occupancy measured using [11C]-NNC 112."
11220379|NCT02333487|FG001|Participant Flow|Lu AF35700 (Group D2)|"Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days).~D2 receptor occupancy measured using [11C]-raclopride."
11220380|NCT02333487|FG002|Participant Flow|Lu AF35700 (Group 5-HT6)|"Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7).~5-HT6 receptor occupancy measured using [11C]-Lu AE60157."
11220381|NCT02333487|OG000|Outcome|Lu AF35700 (Group D1)|Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).
11220382|NCT02333487|OG000|Outcome|Lu AF35700 (Group D1)|Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3)
11220383|NCT02333487|OG000|Outcome|Lu AF35700 (Group D2)|Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days)
11220384|NCT02333487|OG000|Outcome|Lu AF35700 (Group 5-HT6)|Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7).
10836874|NCT00191152|OG000|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
10836875|NCT00191152|OG001|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
10836876|NCT00191152|OG000|Outcome|Gemcitabine Plus Docetaxel|"gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.~Treatment continues until progression of disease at which time crossover treatment begins."
10836877|NCT00191152|OG001|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
10836878|NCT00191152|OG000|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
10836879|NCT00191152|OG001|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
10836880|NCT00191152|OG001|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
10836881|NCT00191152|OG000|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
10836882|NCT00191152|OG001|Outcome|Gemcitabine|gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
10836883|NCT00191152|OG000|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
10836884|NCT00191152|OG001|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
10836885|NCT00191152|OG000|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
10836886|NCT00191152|EG000|Reported Event|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued."
10836887|NCT00191152|EG001|Reported Event|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
10836888|NCT00191165|BG000|Baseline|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
10836889|NCT00191165|BG001|Baseline|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
10836890|NCT00191165|BG002|Baseline|Total|Total of all reporting groups
10836891|NCT00191165|FG000|Participant Flow|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
10836892|NCT00191165|FG001|Participant Flow|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
10836893|NCT00191165|OG000|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
10836894|NCT00191165|OG001|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
10836895|NCT00191165|EG000|Reported Event|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
10836896|NCT00191165|EG001|Reported Event|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
10836897|NCT00191191|BG000|Baseline|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
10836898|NCT00191191|BG001|Baseline|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
10836899|NCT00191191|BG002|Baseline|Total|Total of all reporting groups
10836900|NCT00191191|FG000|Participant Flow|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
10836901|NCT00191191|FG001|Participant Flow|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
10836902|NCT00191191|OG000|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
10836903|NCT00191191|OG001|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
10836904|NCT00191191|EG000|Reported Event|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
10836905|NCT00191191|EG001|Reported Event|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
10836906|NCT00191269|BG000|Baseline|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836907|NCT00191269|BG001|Baseline|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836908|NCT00191269|BG002|Baseline|Total|Total of all reporting groups
10836909|NCT00191269|FG000|Participant Flow|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836910|NCT00191269|FG001|Participant Flow|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836911|NCT00191269|OG000|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836912|NCT00191269|OG001|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836913|NCT00191269|OG000|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
10836914|NCT00191269|EG000|Reported Event|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836915|NCT00191269|EG001|Reported Event|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
10836916|NCT00191282|BG000|Baseline|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
10836917|NCT00191282|BG001|Baseline|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
10836918|NCT00191282|BG002|Baseline|Total|Total of all reporting groups
10836919|NCT00191282|FG000|Participant Flow|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
10836920|NCT00191282|FG001|Participant Flow|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
10836921|NCT00191282|OG000|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
10836922|NCT00191282|OG001|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
10836923|NCT00191282|EG000|Reported Event|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
10836924|NCT00191282|EG001|Reported Event|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
10836925|NCT00191308|BG000|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
10836926|NCT00191308|FG000|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
10836927|NCT00191308|OG000|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
10836928|NCT00191308|EG000|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
10836929|NCT00191334|BG000|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
10836930|NCT00191334|FG000|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
10836931|NCT00191334|OG000|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
10836932|NCT00191334|EG000|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
10836933|NCT00191386|BG000|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
10836934|NCT00191386|FG000|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
10836935|NCT00191386|OG000|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
10836936|NCT00191386|EG000|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
10836937|NCT00191451|BG000|Baseline|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
10836938|NCT00191451|BG001|Baseline|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836939|NCT00191451|BG002|Baseline|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836940|NCT00191451|BG003|Baseline|Total|Total of all reporting groups
10836941|NCT00191451|FG000|Participant Flow|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
10836942|NCT00191451|FG001|Participant Flow|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836943|NCT00191451|FG002|Participant Flow|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836944|NCT00191451|OG000|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
10836945|NCT00191451|OG001|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836946|NCT00191451|OG002|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836947|NCT00191451|EG000|Reported Event|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
10836948|NCT00191451|EG001|Reported Event|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836949|NCT00191451|EG002|Reported Event|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
10836950|NCT00191477|BG000|Baseline|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836951|NCT00191477|BG001|Baseline|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836952|NCT00191477|BG002|Baseline|Total|Total of all reporting groups
10836953|NCT00191477|FG000|Participant Flow|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836954|NCT00191477|FG001|Participant Flow|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836955|NCT00191477|OG000|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836956|NCT00191477|OG001|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
10836957|NCT00191477|EG000|Reported Event|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
10836958|NCT00191477|EG001|Reported Event|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
10836959|NCT00191646|BG000|Baseline|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
10836960|NCT00191646|BG001|Baseline|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
10836961|NCT00191646|BG002|Baseline|Total|Total of all reporting groups
10836962|NCT00191646|FG000|Participant Flow|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
10836963|NCT00191646|FG001|Participant Flow|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
10836964|NCT00191646|OG000|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
10836965|NCT00191646|OG001|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
10836966|NCT00191646|OG000|Outcome|Gemcitabine/Carboplatin (Induction)|Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
10836967|NCT00191646|OG001|Outcome|Paclitaxel/Carboplatin (Induction)|Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
10836968|NCT00191646|OG002|Outcome|Gemcitabine (Crossover)|Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
10836969|NCT00191646|OG003|Outcome|Paclitaxel (Crossover)|Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
10836970|NCT00191646|EG000|Reported Event|Gemcitabine/Carboplatin Induction|Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
10836971|NCT00191646|EG001|Reported Event|Paclitaxel/Carboplatin Induction|Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
10836972|NCT00191646|EG002|Reported Event|Consolidation (Gemcitabine to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
10836973|NCT00191646|EG003|Reported Event|Consolidation (Paclitaxel to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
10836974|NCT00191646|EG004|Reported Event|Crossover (Paclitaxel to Gemcitabine)|Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
10836975|NCT00191646|EG005|Reported Event|Crossover (Gemcitabine to Paclitaxel)|Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
10836976|NCT00191724|BG000|Baseline|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836977|NCT00191724|BG001|Baseline|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836978|NCT00191724|BG002|Baseline|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836979|NCT00191724|BG003|Baseline|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836980|NCT00191724|BG004|Baseline|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836981|NCT00191724|BG005|Baseline|Total|Total of all reporting groups
11220385|NCT02333487|EG000|Reported Event|Lu AF35700 (Group D1)|"Lu AF35700: Daily dosing for up to 21 days (10 mg for 21 days for Cohort A1, 10 mg for 3 days and 15 mg for 18 days for Cohort A2, and 10 mg for 3 days and 20 mg for 17 days for Cohort A3).~D1 receptor occupancy using [11C]-NNC 112"
10836982|NCT00191724|FG000|Participant Flow|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836983|NCT00191724|FG001|Participant Flow|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836984|NCT00191724|FG002|Participant Flow|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836985|NCT00191724|FG003|Participant Flow|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836986|NCT00191724|FG004|Participant Flow|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836987|NCT00191724|OG000|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836988|NCT00191724|OG001|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836989|NCT00191724|OG002|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836990|NCT00191724|OG003|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836991|NCT00191724|OG004|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836992|NCT00191724|EG000|Reported Event|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836993|NCT00191724|EG001|Reported Event|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836994|NCT00191724|EG002|Reported Event|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836995|NCT00191724|EG003|Reported Event|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836996|NCT00191724|EG004|Reported Event|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
10836997|NCT00191789|BG000|Baseline|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
10836998|NCT00191789|FG000|Participant Flow|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
10836999|NCT00191789|OG000|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
10837000|NCT00191789|EG000|Reported Event|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
10842893|NCT00250276|EG001|Reported Event|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842894|NCT00250276|EG002|Reported Event|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
11220386|NCT02333487|EG001|Reported Event|Lu AF35700 (Group D2)|"Lu AF35700: Daily dosing for 21 days (10 mg for 3 days and 20 mg for 18 days).~D2 receptor occupancy using [11C]-raclopride"
10837001|NCT00191815|BG000|Baseline|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
10837002|NCT00191815|FG000|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
10837003|NCT00191815|OG000|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
10837004|NCT00191815|EG000|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
10837005|NCT00191854|BG000|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
10837006|NCT00191854|BG001|Baseline|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
10837007|NCT00191854|BG002|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
10837008|NCT00191854|BG003|Baseline|Total|Total of all reporting groups
10837009|NCT00191854|FG000|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
10837010|NCT00191854|FG001|Participant Flow|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
10837011|NCT00191854|FG002|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
10837012|NCT00191854|OG000|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
10837013|NCT00191854|OG001|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
10837014|NCT00191854|OG002|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
10837015|NCT00191854|EG000|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
10837016|NCT00191854|EG001|Reported Event|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
10837017|NCT00191854|EG002|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
10837018|NCT00191906|BG000|Baseline|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
10837019|NCT00191906|BG001|Baseline|Placebo First, Then Atomoxetine|Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
10837020|NCT00191906|BG002|Baseline|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
10837021|NCT00191906|BG003|Baseline|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
10837022|NCT00191906|BG004|Baseline|Total|Total of all reporting groups
10837023|NCT00191906|FG000|Participant Flow|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
10837024|NCT00191906|FG001|Participant Flow|Placebo First, Then Atomoxetine|Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
10837025|NCT00191906|FG002|Participant Flow|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
10837026|NCT00191906|FG003|Participant Flow|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
10837027|NCT00191906|OG000|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
10837028|NCT00191906|OG001|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
10837029|NCT00191906|OG000|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
10837030|NCT00191906|OG001|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
10837031|NCT00191906|OG000|Outcome|ADHD-C+RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
10837032|NCT00191906|OG001|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
10837033|NCT00191906|OG002|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
10837034|NCT00191906|OG000|Outcome|Atomoxetine|
10837035|NCT00191906|OG001|Outcome|Placebo|
10837036|NCT00191906|OG000|Outcome|ADHD-C+ RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
10837037|NCT00191906|OG000|Outcome|ADHD-C+RD|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
10837038|NCT00191906|EG000|Reported Event|As Randomized Placebo (Crossover)|Patients in either Crossover Period receiving Placebo
10837039|NCT00191906|EG001|Reported Event|As Randomized Atomoxetine (Crossover)|Patients in either Crossover Period receiving Atomoxetine
10837040|NCT00191906|EG002|Reported Event|Open Label Atomoxetine|Patients in the Open Label extension receiving Atomoxetine
10837041|NCT00191945|BG000|Baseline|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837042|NCT00191945|BG001|Baseline|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837043|NCT00191945|BG002|Baseline|Total|Total of all reporting groups
10837044|NCT00191945|FG000|Participant Flow|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837045|NCT00191945|FG001|Participant Flow|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837046|NCT00191945|OG000|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837047|NCT00191945|OG001|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837048|NCT00191945|OG000|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
10837049|NCT00191945|EG000|Reported Event|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837050|NCT00191945|EG001|Reported Event|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
10837051|NCT00191984|BG000|Baseline|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
10837052|NCT00191984|FG000|Participant Flow|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
10837053|NCT00191984|OG000|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
10837054|NCT00191984|EG000|Reported Event|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
10837055|NCT00192023|BG000|Baseline|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837056|NCT00192023|BG001|Baseline|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837057|NCT00192023|BG002|Baseline|Total|Total of all reporting groups
10837058|NCT00192023|FG000|Participant Flow|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837059|NCT00192023|FG001|Participant Flow|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837060|NCT00192023|OG000|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837061|NCT00192023|OG001|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837062|NCT00192023|EG000|Reported Event|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837063|NCT00192023|EG001|Reported Event|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
10837064|NCT00192036|BG000|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
10837065|NCT00192036|FG000|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
10837066|NCT00192036|OG000|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
10837067|NCT00192036|EG000|Reported Event|Gemcitabine + Cisplatin|Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
10837068|NCT00192075|BG000|Baseline|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
10837069|NCT00192075|BG001|Baseline|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
10837070|NCT00192075|BG002|Baseline|Total|Total of all reporting groups
10837071|NCT00192075|FG000|Participant Flow|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
10837072|NCT00192075|FG001|Participant Flow|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
10837073|NCT00192075|OG000|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
10837074|NCT00192075|OG001|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
10837075|NCT00192075|OG000|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
10837076|NCT00192075|OG001|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
10837077|NCT00192075|OG001|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
10837078|NCT00192075|OG000|Outcome|A+FFG - Avastin Subgrouup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
10837079|NCT00192075|OG000|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
10837080|NCT00192075|EG000|Reported Event|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
10837081|NCT00192075|EG001|Reported Event|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
10837082|NCT00192114|BG000|Baseline|Enzastaurin HCl|1200 milligrams (mg) administered orally as a loading dose, then 500 mg administered orally, once daily, for up to six 28-day cycles.
10837083|NCT00192114|FG000|Participant Flow|Enzastaurin HCl|1200 milligrams (mg) administered orally as a loading dose then 500 mg administered orally, once daily, for up to six 28-day cycles.
10837084|NCT00192114|OG000|Outcome|Enzastaurin HCl|1200 milligrams (mg) administered orally as a loading dose, then 500 mg administered orally, once daily, for up to six 28-day cycles.
10837085|NCT00192114|EG000|Reported Event|Enzastaurin HCl|1200 milligrams (mg) of enzastaurin HCl administered orally as a loading dose then 500 mg, administered orally once daily up to six 28-day cycles.
10837086|NCT00192296|BG000|Baseline|MEDI-528 0.3 mg|
10837087|NCT00192296|BG001|Baseline|MEDI-528 1 mg|
10837088|NCT00192296|BG002|Baseline|MEDI-528 3 mg|
10837089|NCT00192296|BG003|Baseline|MEDI-528 9 mg|
10837090|NCT00192296|BG004|Baseline|Total|Total of all reporting groups
10837091|NCT00192296|FG000|Participant Flow|MEDI-528 0.3 mg|
10837092|NCT00192296|FG001|Participant Flow|MEDI-528 1 mg|
10837093|NCT00192296|FG002|Participant Flow|MEDI-528 3 mg|
10837094|NCT00192296|FG003|Participant Flow|MEDI-528 9 mg|
10837095|NCT00192296|OG000|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
10837096|NCT00192296|OG001|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
10837097|NCT00192296|OG002|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
10837098|NCT00192296|OG003|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
10837099|NCT00192296|EG000|Reported Event|MEDI-528 0.3 mg|
10837100|NCT00192296|EG001|Reported Event|MEDI-528 1 mg|
10837101|NCT00192296|EG002|Reported Event|MEDI-528 3 mg|
10837102|NCT00192296|EG003|Reported Event|MEDI-528 9 mg|
10837103|NCT00192504|BG000|Baseline|Motavizumab (MEDI-524), 3 mg/kg|Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
10837104|NCT00192504|BG001|Baseline|Motavizumab (MEDI-524), 15 mg/kg|Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
10837105|NCT00192504|BG002|Baseline|Motavizumab (MEDI-524), 30 mg/kg|Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
10837106|NCT00192504|BG003|Baseline|Placebo|Placebo, as a single intravenous dose administered on Day 0
10837107|NCT00192504|BG004|Baseline|Total|Total of all reporting groups
10837108|NCT00192504|FG000|Participant Flow|Motavizumab (MEDI-524), 3 mg/kg|Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
10837109|NCT00192504|FG001|Participant Flow|Motavizumab (MEDI-524), 15 mg/kg|Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
10837110|NCT00192504|FG002|Participant Flow|Motavizumab (MEDI-524), 30 mg/kg|Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
10837111|NCT00192504|FG003|Participant Flow|Placebo|Placebo, as a single intravenous dose administered on Day 0
10837112|NCT00192504|OG000|Outcome|Motavizumab (MEDI-524), 3 mg/kg|Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
10837113|NCT00192504|OG001|Outcome|Motavizumab (MEDI-524), 15 mg/kg|Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
10837114|NCT00192504|OG002|Outcome|Motavizumab (MEDI-524), 30 mg/kg|Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
10837115|NCT00192504|OG003|Outcome|Placebo|Placebo, as a single intravenous dose administered on Day 0
10837116|NCT00192504|EG000|Reported Event|Motavizumab (MEDI-524), 3 mg/kg|Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
10837117|NCT00192504|EG001|Reported Event|Motavizumab (MEDI-524), 15 mg/kg|Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
10837118|NCT00192504|EG002|Reported Event|Motavizumab (MEDI-524), 30 mg/kg|Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
10837119|NCT00192504|EG003|Reported Event|Placebo|Placebo, as a single intravenous dose administered on Day 0
10837120|NCT00192647|BG000|Baseline|PEG-IFN Alfa-2a+Ribavirin - Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
10837121|NCT00192647|BG001|Baseline|PEG-IFN Alfa-2a+Ribavirin - Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
10837122|NCT00192647|BG002|Baseline|Total|Total of all reporting groups
10837123|NCT00192647|FG000|Participant Flow|PEG-IFN Alfa-2a+Ribavirin - Induction Treatment|Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
10837124|NCT00192647|FG001|Participant Flow|PEG-IFN Alfa-2a+Ribavirin - Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
10837125|NCT00192647|OG000|Outcome|PEG-IFN Alfa-2a+Ribavirin - Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
10837126|NCT00192647|OG001|Outcome|PEG-IFN Alfa-2a+Ribavirin - Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
10837127|NCT00192647|EG000|Reported Event|PEG-IFN Alfa-2a+Ribavirin - Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
10837128|NCT00192647|EG001|Reported Event|PEG-IFN Alfa-2a+Ribavirin - Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
10837129|NCT00193037|BG000|Baseline|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
10837130|NCT00193037|BG001|Baseline|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
10837131|NCT00193037|BG002|Baseline|Total|Total of all reporting groups
10837132|NCT00193037|FG000|Participant Flow|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria."
10837133|NCT00193037|FG001|Participant Flow|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria."
10837134|NCT00193037|OG000|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
10837135|NCT00193037|OG001|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
10837136|NCT00193037|EG000|Reported Event|Arm A - Liposomal Doxorubicin Then Docetaxel|Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
10837137|NCT00193037|EG001|Reported Event|Arm B - Docetaxel Then Liposomal Doxorubicin|Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
10842895|NCT00250276|EG003|Reported Event|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
10843315|NCT00253643|FG001|Participant Flow|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
10837138|NCT00193050|BG000|Baseline|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
10837139|NCT00193050|FG000|Participant Flow|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
10837140|NCT00193050|OG000|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
10837141|NCT00193050|OG000|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.~Gemcitabine: Gemcitabine~Epirubicin: Epirubicin~Docetaxel: Docetaxel"
10837142|NCT00193050|EG000|Reported Event|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
10837143|NCT00193063|BG000|Baseline|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
10837144|NCT00193063|FG000|Participant Flow|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
10837145|NCT00193063|OG000|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
10837146|NCT00193063|EG000|Reported Event|Intervention|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
10837147|NCT00193128|BG000|Baseline|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"oxaliplatin, docetaxel and radiation therapy~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began."
10837148|NCT00193128|BG001|Baseline|Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)|"Oxaliplatin, docetaxel, capecitabine, and radiation therapy.~Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported."
10837149|NCT00193128|BG002|Baseline|Total|Total of all reporting groups
10837150|NCT00193128|FG000|Participant Flow|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"oxaliplatin, docetaxel and radiation therapy~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began."
10837151|NCT00193128|FG001|Participant Flow|Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)|"Oxaliplatin, docetaxel, capecitabine, and radiation therapy.~Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported."
10837152|NCT00193128|OG000|Outcome|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"Oxaliplatin, docetaxel, and radiation therapy.~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began."
10837153|NCT00193128|OG001|Outcome|Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)|"Oxaliplatin, docetaxel, capecitabine, and radiation therapy.~Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported."
10837154|NCT00193128|OG000|Outcome|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"oxaliplatin, docetaxel and radiation therapy~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began."
10837155|NCT00193128|OG000|Outcome|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"oxaliplatin, docetaxel and radiation therapy~Oxaliplatin, docetaxel, and radiation therapy.~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began"
10837156|NCT00193128|EG000|Reported Event|Oxaliplatin/Docetaxel/Radiation (Cohort 1)|"Oxaliplatin, docetaxel, and radiation therapy.~Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began."
10837157|NCT00193128|EG001|Reported Event|Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)|"Oxaliplatin, docetaxel, capecitabine, and radiation therapy.~Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported."
10837158|NCT00193180|BG000|Baseline|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
10837159|NCT00193180|FG000|Participant Flow|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
10837160|NCT00193180|OG000|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
10837161|NCT00193180|OG000|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
10837162|NCT00193180|EG000|Reported Event|Docetaxel+Imatinib|Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
10837163|NCT00193206|BG000|Baseline|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
10837164|NCT00193206|FG000|Participant Flow|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
10837165|NCT00193206|OG000|Outcome|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
10837166|NCT00193206|EG000|Reported Event|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
10837167|NCT00193258|BG000|Baseline|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
10837168|NCT00193258|FG000|Participant Flow|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
10837169|NCT00193258|OG000|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
10837170|NCT00193258|EG000|Reported Event|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
10837171|NCT00193375|BG000|Baseline|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
10837172|NCT00193375|FG000|Participant Flow|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
10837173|NCT00193375|OG000|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
10837174|NCT00193375|EG000|Reported Event|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
10837175|NCT00193453|BG000|Baseline|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
10837176|NCT00193453|FG000|Participant Flow|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
10837177|NCT00193453|OG000|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
10837178|NCT00193453|EG000|Reported Event|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
10837179|NCT00193492|BG000|Baseline|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
10837180|NCT00193492|BG001|Baseline|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
10837181|NCT00193492|BG002|Baseline|Total|Total of all reporting groups
10837182|NCT00193492|FG000|Participant Flow|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
10837183|NCT00193492|FG001|Participant Flow|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
10837184|NCT00193492|OG000|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
10837185|NCT00193492|OG001|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
10837186|NCT00193492|EG000|Reported Event|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
10837187|NCT00193492|EG001|Reported Event|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
10837188|NCT00193596|BG000|Baseline|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
10837189|NCT00193596|BG001|Baseline|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
10837190|NCT00193596|BG002|Baseline|Total|Total of all reporting groups
10837191|NCT00193596|FG000|Participant Flow|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
10837192|NCT00193596|FG001|Participant Flow|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
10837193|NCT00193596|OG000|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
10837194|NCT00193596|OG001|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
10837195|NCT00193596|EG000|Reported Event|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
10837196|NCT00193596|EG001|Reported Event|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
10837197|NCT00193609|BG000|Baseline|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
10837198|NCT00193609|FG000|Participant Flow|Oxaliplatin/Capecitabine|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
10837199|NCT00193609|OG000|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
10837200|NCT00193609|EG000|Reported Event|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
10837201|NCT00194012|BG000|Baseline|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837202|NCT00194012|BG001|Baseline|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
10837203|NCT00194012|BG002|Baseline|Total|Total of all reporting groups
10837204|NCT00194012|FG000|Participant Flow|Aripiprazole|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837205|NCT00194012|FG001|Participant Flow|Placebo|placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
10837206|NCT00194012|OG000|Outcome|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837207|NCT00194012|OG001|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
10837208|NCT00194012|OG000|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
10837209|NCT00194012|OG001|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
10837210|NCT00194012|OG000|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837211|NCT00194012|OG000|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837212|NCT00194012|EG000|Reported Event|Abilify Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
10837213|NCT00194012|EG001|Reported Event|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
10837214|NCT00194012|EG002|Reported Event|Open Label Extension (Abilify)|Previously randomized to Abilify group.
10837215|NCT00194012|EG003|Reported Event|Open Label Extension (Placebo)|Previously randomized to placebo group.
10837216|NCT00194025|BG000|Baseline|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
10837217|NCT00194025|FG000|Participant Flow|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
10837218|NCT00194025|OG000|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
10837219|NCT00194025|EG000|Reported Event|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
10837220|NCT00194077|BG000|Baseline|Aripiprazole|Abilify (Children with Symptoms of Mania Study)
10837221|NCT00194077|BG001|Baseline|Placebo|Placebo (Children with Symptoms of Mania Study)
10837222|NCT00194077|BG002|Baseline|Total|Total of all reporting groups
10837223|NCT00194077|FG000|Participant Flow|Aripiprazole|Random assignment with titrated dosing
10837224|NCT00194077|FG001|Participant Flow|Placebo|Randomized assignment to placebo
10837225|NCT00194077|OG000|Outcome|Aripiprazole|Aripiprazole dosing dependent upon response
10837226|NCT00194077|OG001|Outcome|Placebo|Placebo dosing to mirror active treatment
10837227|NCT00194077|EG000|Reported Event|Aripiprazole|Abilify (Children With Symptoms of Mania Study)
10837228|NCT00194077|EG001|Reported Event|Placebo|Placebo (Children With Symptoms of Mania Study)
10837229|NCT00194116|BG000|Baseline|Divalproex Sodium ER|Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837230|NCT00194116|BG001|Baseline|Placebo|Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837231|NCT00194116|BG002|Baseline|Total|Total of all reporting groups
10837232|NCT00194116|FG000|Participant Flow|Divalproex Sodium ER|Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837233|NCT00194116|FG001|Participant Flow|Placebo|Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837234|NCT00194116|OG000|Outcome|Divalproex Sodium ER|Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837235|NCT00194116|OG001|Outcome|Placebo|Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837236|NCT00194116|EG000|Reported Event|Divalproex Sodium ER|Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837237|NCT00194116|EG001|Reported Event|Placebo|Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
10837238|NCT00194129|BG000|Baseline|Lithium Plus Divalproex|
10837239|NCT00194129|BG001|Baseline|Lithium Plus Placebo|
10837240|NCT00194129|BG002|Baseline|Total|Total of all reporting groups
10837241|NCT00194129|FG000|Participant Flow|Lithium Plus Divalproex|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to divalproex arm, divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
10837242|NCT00194129|FG001|Participant Flow|Lithium Plus Placebo|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to placebo arm, placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
10837243|NCT00194129|OG000|Outcome|Lithium Plus Divalproex|
10837244|NCT00194129|OG001|Outcome|Lithium Plus Placebo|
10837245|NCT00194129|OG000|Outcome|Lithium Plus Divalproex|"Patients assigned to the combination group were continued on lithium and blinded divalproex.~Lithium: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.~Divalproex: Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml."
10837246|NCT00194129|OG001|Outcome|Lithium Plus Placebo|"Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.~Lithium: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.~Placebo: Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily."
10837247|NCT00194129|OG000|Outcome|Lithium Plus Divalproex|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to divalproex arm, divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
10837248|NCT00194129|OG001|Outcome|Lithium Plus Placebo|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to placebo arm, placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
10837249|NCT00194129|OG000|Outcome|Completers|This analysis only includes subjects who had an alcohol use disorder at study entry.
10837250|NCT00194129|OG000|Outcome|Completers|This only includes subjects who had a cannabis use disorder at study entry.
10837251|NCT00194129|OG000|Outcome|Completers|This only includes subjects who had cocaine use disorder at study entry.
10837252|NCT00194129|EG000|Reported Event|Lithium Plus Divalproex|
10837253|NCT00194129|EG001|Reported Event|Lithium Plus Placebo|
10837254|NCT00194532|BG000|Baseline|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
10837255|NCT00194532|BG001|Baseline|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
10837256|NCT00194532|BG002|Baseline|Total|Total of all reporting groups
10837257|NCT00194532|FG000|Participant Flow|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
10837258|NCT00194532|FG001|Participant Flow|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
10837259|NCT00194532|OG000|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
10837260|NCT00194532|OG001|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
10837261|NCT00194532|EG000|Reported Event|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
10837262|NCT00194532|EG001|Reported Event|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
10837263|NCT00194610|BG000|Baseline|Saline|Total 2 cc injected periurethrally
10837264|NCT00194610|BG001|Baseline|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
10837265|NCT00194610|BG002|Baseline|Total|Total of all reporting groups
10837266|NCT00194610|FG000|Participant Flow|Saline|Total 2 cc injected periurethrally
10837267|NCT00194610|FG001|Participant Flow|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
10837268|NCT00194610|OG000|Outcome|Placebo : Saline|Saline 2 cc total injected periurethrally
10837269|NCT00194610|OG001|Outcome|Experimental Intervention: Botox|Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
10837270|NCT00194610|EG000|Reported Event|Saline|Total 2 cc injected periurethrally
10837271|NCT00194610|EG001|Reported Event|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
10837272|NCT00194675|BG000|Baseline|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
10837273|NCT00194675|BG001|Baseline|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
10837274|NCT00194675|BG002|Baseline|Total|Total of all reporting groups
10837275|NCT00194675|FG000|Participant Flow|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
10837276|NCT00194675|FG001|Participant Flow|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
10837277|NCT00194675|OG000|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
10837278|NCT00194675|OG001|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
10837279|NCT00194675|OG000|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
10837280|NCT00194675|OG001|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
10837281|NCT00194675|EG000|Reported Event|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
10837282|NCT00194675|EG001|Reported Event|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
10837283|NCT00194779|BG000|Baseline|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
10837284|NCT00194779|FG000|Participant Flow|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
10837285|NCT00194779|OG000|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
10837286|NCT00194779|EG000|Reported Event|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
10837287|NCT00194792|BG000|Baseline|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
10837288|NCT00194792|FG000|Participant Flow|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
10837289|NCT00194792|OG000|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
10837290|NCT00194792|EG000|Reported Event|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
10837291|NCT00194896|BG000|Baseline|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
10837292|NCT00194896|BG001|Baseline|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837293|NCT00194896|BG002|Baseline|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
10837294|NCT00194896|BG003|Baseline|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837295|NCT00194896|BG004|Baseline|Total|Total of all reporting groups
10837296|NCT00194896|FG000|Participant Flow|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
10837297|NCT00194896|FG001|Participant Flow|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837298|NCT00194896|FG002|Participant Flow|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
10837299|NCT00194896|FG003|Participant Flow|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837300|NCT00194896|OG000|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
10837301|NCT00194896|OG001|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837302|NCT00194896|OG002|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
10837303|NCT00194896|OG003|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837304|NCT00194896|EG000|Reported Event|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
10837305|NCT00194896|EG001|Reported Event|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837306|NCT00194896|EG002|Reported Event|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
10837307|NCT00194896|EG003|Reported Event|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
10837308|NCT00194987|BG000|Baseline|IVIG (Intravenous Gamma Globulin) 2g/kg/Week|pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 2 g/kg/week
10837309|NCT00194987|BG001|Baseline|IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day|pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 1 g/kg/week + prednisone 0.5mg/kg/day
10837310|NCT00194987|BG002|Baseline|Total|Total of all reporting groups
10837311|NCT00194987|FG000|Participant Flow|Intravenous Gammglobulin (IVIG) 1g/kg Twice Per Week|"51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.~premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered"
10837312|NCT00194987|FG001|Participant Flow|IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day|IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
10837313|NCT00194987|OG000|Outcome|IVIG 1g/kg Twice Per Week|"51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.~premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was < 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered"
10837314|NCT00194987|OG001|Outcome|IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day|IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was < 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be > 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
10837315|NCT00194987|EG000|Reported Event|IVIG X 2 Weekly|"Intravenous Immunoglobulin (IVIG) one gram per kg bodyweight infused twice weekly to mothers during pregnancy~fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth"
10837316|NCT00194987|EG001|Reported Event|IVIG 1 g/kg/wk + Prednisone|"intravenous gammaglobulin 1 g/kg/wk infused once weekly to mother and prednisone 0.5 mg/kg/day taken by mothers during pregnancy and then tapered after birth fo newborn~fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth"
10837317|NCT00194987|EG002|Reported Event|IVIG X 2 Weekly--fetuses/Newborns|fetuses and newborns of mother receiving IVIG x 2 weekly
10837318|NCT00194987|EG003|Reported Event|IVIG x 1 + Prednisone---fetuses/Newborns|fetuses and newborns of mother receiving IVIG x 1 weekly + prednisone 0.5mg/kg daily
10837319|NCT00195013|BG000|Baseline|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
10837320|NCT00195013|BG001|Baseline|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
10837321|NCT00195013|BG002|Baseline|Total|Total of all reporting groups
10837322|NCT00195013|FG000|Participant Flow|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
10837323|NCT00195013|FG001|Participant Flow|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
10837324|NCT00195013|OG000|Outcome|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
10837325|NCT00195013|OG001|Outcome|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
10837326|NCT00195013|EG000|Reported Event|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
10837327|NCT00195013|EG001|Reported Event|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
10837328|NCT00195039|BG000|Baseline|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
10837329|NCT00195039|FG000|Participant Flow|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
10837330|NCT00195039|OG000|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
10837331|NCT00195039|EG000|Reported Event|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
10837332|NCT00195260|BG000|Baseline|Part 1|Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
10837333|NCT00195260|BG001|Baseline|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837334|NCT00195260|BG002|Baseline|Total|Total of all reporting groups
10837335|NCT00195260|FG000|Participant Flow|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837336|NCT00195260|FG001|Participant Flow|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837337|NCT00195260|FG002|Participant Flow|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837338|NCT00195260|FG003|Participant Flow|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837339|NCT00195260|FG004|Participant Flow|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837340|NCT00195260|FG005|Participant Flow|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837341|NCT00195260|FG006|Participant Flow|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837342|NCT00195260|FG007|Participant Flow|Maximum Tolerated Dose (MTD) lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837343|NCT00195260|FG008|Participant Flow|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837344|NCT00195260|FG009|Participant Flow|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837345|NCT00195260|FG010|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837346|NCT00195260|OG000|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837347|NCT00195260|OG001|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837348|NCT00195260|OG002|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837349|NCT00195260|OG003|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837350|NCT00195260|OG004|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837351|NCT00195260|OG005|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837352|NCT00195260|OG006|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837353|NCT00195260|OG007|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837354|NCT00195260|OG008|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837355|NCT00195260|OG007|Outcome|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837356|NCT00195260|OG005|Outcome|Bosutinib 500 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837357|NCT00195260|OG006|Outcome|Bosutinib 600 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837358|NCT00195260|OG000|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837359|NCT00195260|OG001|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837360|NCT00195260|OG002|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837361|NCT00195260|OG000|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837362|NCT00195260|OG004|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
10837363|NCT00195260|EG000|Reported Event|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837364|NCT00195260|EG001|Reported Event|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837365|NCT00195260|EG002|Reported Event|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837366|NCT00195260|EG003|Reported Event|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837367|NCT00195260|EG004|Reported Event|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837368|NCT00195260|EG005|Reported Event|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837369|NCT00195260|EG006|Reported Event|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837370|NCT00195260|EG007|Reported Event|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837371|NCT00195260|EG008|Reported Event|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
10837372|NCT00195273|BG000|Baseline|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837373|NCT00195273|BG001|Baseline|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837374|NCT00195273|BG002|Baseline|Total|Total of all reporting groups
10837375|NCT00195273|FG000|Participant Flow|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837376|NCT00195273|FG001|Participant Flow|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837377|NCT00195273|OG000|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837378|NCT00195273|OG001|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837379|NCT00195273|EG000|Reported Event|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837380|NCT00195273|EG001|Reported Event|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
10837381|NCT00195338|BG000|Baseline|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
10837382|NCT00195338|FG000|Participant Flow|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
10837383|NCT00195338|OG000|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
10837384|NCT00195338|EG000|Reported Event|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
10837385|NCT00195351|BG000|Baseline|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10837386|NCT00195351|BG001|Baseline|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
10837387|NCT00195351|BG002|Baseline|Total|Total of all reporting groups
10837388|NCT00195351|FG000|Participant Flow|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10837389|NCT00195351|FG001|Participant Flow|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
10837390|NCT00195351|OG000|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10837391|NCT00195351|OG001|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
10837392|NCT00195351|EG000|Reported Event|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10837393|NCT00195351|EG001|Reported Event|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
10837394|NCT00195403|BG000|Baseline|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
10837395|NCT00195403|FG000|Participant Flow|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
10837396|NCT00195403|OG000|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
10837397|NCT00195403|EG000|Reported Event|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
10837398|NCT00195429|BG000|Baseline|Sirolimus + Tacrolimus|
10837399|NCT00195429|BG001|Baseline|Sirolimus + Prednisone|
10837400|NCT00195429|BG002|Baseline|Total|Total of all reporting groups
10837401|NCT00195429|FG000|Participant Flow|Sirolimus + Tacrolimus|
10837402|NCT00195429|FG001|Participant Flow|Sirolimus + Prednisone|
10837403|NCT00195429|OG000|Outcome|Sirolimus + Tacrolimus|
10837404|NCT00195429|OG001|Outcome|Sirolimus + Prednisone|
10837405|NCT00195429|EG000|Reported Event|Sirolimus + Tacrolimus|
10837406|NCT00195429|EG001|Reported Event|Sirolimus + Prednisone|
10837407|NCT00195442|BG000|Baseline|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
10837408|NCT00195442|FG000|Participant Flow|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
10837409|NCT00195442|OG000|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
10837410|NCT00195442|EG000|Reported Event|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
10837411|NCT00195494|BG000|Baseline|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837412|NCT00195494|BG001|Baseline|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837413|NCT00195494|BG002|Baseline|Total|Total of all reporting groups
10837414|NCT00195494|FG000|Participant Flow|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837415|NCT00195494|FG001|Participant Flow|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837416|NCT00195494|FG002|Participant Flow|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
10837417|NCT00195494|FG003|Participant Flow|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
10837418|NCT00195494|FG004|Participant Flow|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837419|NCT00195494|FG005|Participant Flow|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837420|NCT00195494|OG000|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
10837421|NCT00195494|OG001|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
10837422|NCT00195494|OG000|Outcome|Year 2 E+M / E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837423|NCT00195494|OG001|Outcome|Year 2 M / E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837424|NCT00195494|OG002|Outcome|Year 2 E+M / E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
10837425|NCT00195494|OG003|Outcome|Year 2 M / M|"Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
10837426|NCT00195494|OG004|Outcome|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837427|NCT00195494|OG005|Outcome|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837428|NCT00195494|EG000|Reported Event|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837429|NCT00195494|EG001|Reported Event|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
10837430|NCT00195494|EG002|Reported Event|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
10837431|NCT00195494|EG003|Reported Event|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
10837432|NCT00195494|EG004|Reported Event|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837433|NCT00195494|EG005|Reported Event|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
10837434|NCT00195507|BG000|Baseline|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
10837435|NCT00195507|BG001|Baseline|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
10837436|NCT00195507|BG002|Baseline|Total|Total of all reporting groups
10837437|NCT00195507|FG000|Participant Flow|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
10837438|NCT00195507|FG001|Participant Flow|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
10837439|NCT00195507|OG000|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
10837440|NCT00195507|OG001|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
10837441|NCT00195507|EG000|Reported Event|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
10837442|NCT00195507|EG001|Reported Event|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
10837443|NCT00195624|BG000|Baseline|Refractory|Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
10837444|NCT00195624|BG001|Baseline|Relapsed|Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
10837445|NCT00195624|BG002|Baseline|Total|Total of all reporting groups
10837446|NCT00195624|FG000|Participant Flow|Refractory|Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
10837447|NCT00195624|FG001|Participant Flow|Relapsed|Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
10837448|NCT00195624|OG000|Outcome|Refractory|Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
10837449|NCT00195624|OG001|Outcome|Relapsed|Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
10837450|NCT00195624|EG000|Reported Event|Refractory|Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
10837451|NCT00195624|EG001|Reported Event|Relapsed|Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
10837452|NCT00195650|BG000|Baseline|Adalimumab|Open-label adalimumab 40 mg
10837453|NCT00195650|FG000|Participant Flow|Adalimumab|Open-label adalimumab 40 mg
10837454|NCT00195650|OG000|Outcome|Adalimumab|Open-label adalimumab 40 mg
10837455|NCT00195650|EG000|Reported Event|Adalimumab|Open-label adalimumab 40 mg
10837456|NCT00195663|BG000|Baseline|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837457|NCT00195663|BG001|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
10837458|NCT00195663|BG002|Baseline|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837459|NCT00195663|BG003|Baseline|Total|Total of all reporting groups
10837460|NCT00195663|FG000|Participant Flow|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837461|NCT00195663|FG001|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
10837462|NCT00195663|FG002|Participant Flow|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837463|NCT00195663|OG000|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
10837464|NCT00195663|OG001|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
10837465|NCT00195663|OG002|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
10837466|NCT00195663|OG000|Outcome|Methotrexate Weekly|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
10837467|NCT00195663|OG000|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
10837468|NCT00195663|OG000|Outcome|Adalimumab: DAS28 < 2.6|Participants with a DAS28 score less than 2.6, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
10837469|NCT00195663|OG001|Outcome|Adalimumab: DAS28 < 3.2|Participants with a DAS28 score less than 3.2, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
10837470|NCT00195663|OG000|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837471|NCT00195663|OG001|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
10837472|NCT00195663|OG002|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
10837473|NCT00195663|OG000|Outcome|Adalimumab: HAQ Decrease ≥ 0.22|Participants with a decrease of least 0.22 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
10837474|NCT00195663|OG001|Outcome|Adalimumab: HAQ Decrease ≥ 0.5|Participants with a decrease of least 0.5 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
10837475|NCT00195663|EG000|Reported Event|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
10837476|NCT00195663|EG001|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
10837477|NCT00195663|EG002|Reported Event|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
10837478|NCT00195663|EG003|Reported Event|Any Adalimumab|"Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.~Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years)."
10837479|NCT00195676|BG000|Baseline|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
10837480|NCT00195676|FG000|Participant Flow|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
10837481|NCT00195676|OG000|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
10837482|NCT00195676|OG000|Outcome|Period R Modified Intent-to-Treat Population|Participants of the Period W Modified Intent-to-Treat(mITT) Population who received at least one retreatment dose of adalimumab 40 mg every other week in Period R. The Period W mITT Population had entered Period W from Period O with stable psoriasis control [i.e., had a PGA of 0 or 1 at the last 2 consecutive visits in Period O, at least 12 weeks apart, and were on adalimumab 40 mg every other week for the last 12 weeks of Period O).
10837483|NCT00195676|OG000|Outcome|Period W Modified Intent-to-treat Population|Participants from Period O who entered Period W with a PGA of 0 or 1 for the last 2 consecutive visits of Period O, at least 12 weeks apart, and received adalimumab 40 mg every other week for at least 12 weeks prior to entering Period W.
10837484|NCT00195676|OG000|Outcome|Period R mITT Population Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had relapsed in Period W after adalimumab therapy was withdrawn.
10837485|NCT00195676|OG000|Outcome|Period R Modified Intent-to-Treat Not Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had not relapsed (i.e., PGA not greater than or equal to 3) in Period W after adalimumab therapy was withdrawn.
10837486|NCT00195676|EG000|Reported Event|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
10837487|NCT00195702|BG000|Baseline|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
10837488|NCT00195702|BG001|Baseline|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837489|NCT00195702|BG002|Baseline|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837490|NCT00195702|BG003|Baseline|Total|Total of all reporting groups
10837491|NCT00195702|FG000|Participant Flow|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837492|NCT00195702|FG001|Participant Flow|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837493|NCT00195702|FG002|Participant Flow|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837494|NCT00195702|FG003|Participant Flow|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
10837495|NCT00195702|FG004|Participant Flow|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
10837496|NCT00195702|FG005|Participant Flow|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
10837497|NCT00195702|OG000|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
10837498|NCT00195702|OG001|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837499|NCT00195702|OG002|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837500|NCT00195702|OG000|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
10837501|NCT00195702|OG000|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
10837502|NCT00195702|OG001|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
10837503|NCT00195702|OG002|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
10837504|NCT00195702|EG000|Reported Event|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
10837505|NCT00195702|EG001|Reported Event|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837506|NCT00195702|EG002|Reported Event|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
10837507|NCT00195702|EG003|Reported Event|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
10837508|NCT00195715|BG000|Baseline|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
10837509|NCT00195715|FG000|Participant Flow|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
10837510|NCT00195715|OG000|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
10837511|NCT00195715|EG000|Reported Event|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
10837512|NCT00195819|BG000|Baseline|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
10837513|NCT00195819|FG000|Participant Flow|Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)|
10837514|NCT00195819|FG001|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
10837515|NCT00195819|OG000|Outcome|Adalimumab|40 mg every other week, subcutaneous
10837516|NCT00195819|OG001|Outcome|Placebo|40 mg every other week, subcutaneous
10837517|NCT00195819|OG000|Outcome|Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
10837518|NCT00195819|OG000|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
10837519|NCT00195819|OG000|Outcome|Adalimumab|Adalimumab every other week (eow)
10837520|NCT00195819|OG001|Outcome|Placebo|(Week 52 - Placebo plus up to 40 weeks adalimumab)
10837521|NCT00195819|OG000|Outcome|Adalimumab Exposure|Adalimumab 40 mg every other week (eow)
10837522|NCT00195819|OG001|Outcome|Placebo|(Week 52 - placebo plus up to 40 weeks of adalimumab)
10837523|NCT00195819|OG000|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
10837524|NCT00195819|EG000|Reported Event|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
10837525|NCT00196105|BG000|Baseline|6 mm Zilver|6 mm Nitinol Zilver Stent
10837526|NCT00196105|BG001|Baseline|10 mm Zilver|10 mm Nitinol Zilver Stent
10837527|NCT00196105|BG002|Baseline|10 mm Wallstent|10 mm Stainless Steel Wallstent
10837528|NCT00196105|BG003|Baseline|Total|Total of all reporting groups
10837529|NCT00196105|FG000|Participant Flow|6 mm Zilver|6 mm Nitinol Zilver Stent
10837530|NCT00196105|FG001|Participant Flow|10 mm Zilver|10 mm Nitinol Zilver Stent
10837531|NCT00196105|FG002|Participant Flow|10 mm Wallstent|10 mm Stainless Steel Wallstent
10837532|NCT00196105|OG000|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
10837533|NCT00196105|OG001|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
10837534|NCT00196105|OG002|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
10837535|NCT00196105|EG000|Reported Event|6 mm Zilver|6 mm Nitinol Zilver Stent
10837536|NCT00196105|EG001|Reported Event|10 mm Zilver|10 mm Nitinol Zilver Stent
10837537|NCT00196105|EG002|Reported Event|10 mm Wallstent|10 mm Stainless Steel Wallstent
10837538|NCT00196196|BG000|Baseline|Codman VPV System|
10837539|NCT00196196|FG000|Participant Flow|Codman VPV System|
10837540|NCT00196196|OG000|Outcome|Codman VPV System|
10837541|NCT00196196|EG000|Reported Event|Codman VPV System|
10837542|NCT00196313|BG000|Baseline|Seasonique|"Seasonique~, 1 tablet daily"
10837543|NCT00196313|BG001|Baseline|Placebo|Placebo, 1 tablet daily
10837544|NCT00196313|BG002|Baseline|Total|Total of all reporting groups
10837545|NCT00196313|FG000|Participant Flow|Seasonique|"Seasonique~, 1 tablet daily"
10837546|NCT00196313|FG001|Participant Flow|Placebo|Placebo, 1 tablet daily
10837547|NCT00196313|OG000|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
10837548|NCT00196313|OG001|Outcome|Placebo|Placebo, 1 tablet daily
10837549|NCT00196313|OG000|Outcome|Seasonique|Seasonique, 1 tablet daily
10837550|NCT00196313|EG000|Reported Event|Seasonique|"Seasonique~, 1 tablet daily"
10837551|NCT00196313|EG001|Reported Event|Placebo|Placebo, 1 tablet daily
10837552|NCT00196326|BG000|Baseline|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
10837553|NCT00196326|FG000|Participant Flow|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
10837554|NCT00196326|OG000|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
10837555|NCT00196326|EG000|Reported Event|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
10837556|NCT00196716|BG000|Baseline|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
10837557|NCT00196716|FG000|Participant Flow|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
10837558|NCT00196716|OG000|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
10837559|NCT00196716|EG000|Reported Event|1.0 mg/kg Fabrazyme|1.0 mg/kg Fabrazyme, Week 0 to Week 24.
10837560|NCT00196716|EG001|Reported Event|0.3 mg/kg Fabrazyme|0.3 mg/kg Fabrazyme, Week 24 to Week 96.
10837561|NCT00196716|EG002|Reported Event|Total|
10837562|NCT00196937|BG000|Baseline|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837563|NCT00196937|BG001|Baseline|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837564|NCT00196937|BG002|Baseline|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837565|NCT00196937|BG003|Baseline|Total|Total of all reporting groups
10837566|NCT00196937|FG000|Participant Flow|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837567|NCT00196937|FG001|Participant Flow|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837568|NCT00196937|FG002|Participant Flow|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837569|NCT00196937|OG000|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837570|NCT00196937|OG001|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837571|NCT00196937|OG002|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837572|NCT00196937|OG000|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837573|NCT00196937|EG000|Reported Event|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837574|NCT00196937|EG001|Reported Event|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837575|NCT00196937|EG002|Reported Event|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
10837576|NCT00196976|BG000|Baseline|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837577|NCT00196976|BG001|Baseline|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837578|NCT00196976|BG002|Baseline|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837579|NCT00196976|BG003|Baseline|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837580|NCT00196976|BG004|Baseline|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837581|NCT00196976|BG005|Baseline|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837582|NCT00196976|BG006|Baseline|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837583|NCT00196976|BG007|Baseline|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837584|NCT00196976|BG008|Baseline|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837585|NCT00196976|BG009|Baseline|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837586|NCT00196976|BG010|Baseline|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837587|NCT00196976|BG011|Baseline|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837588|NCT00196976|BG012|Baseline|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
10837589|NCT00196976|BG013|Baseline|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
10837590|NCT00196976|BG014|Baseline|Total|Total of all reporting groups
10837591|NCT00196976|FG000|Participant Flow|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837592|NCT00196976|FG001|Participant Flow|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837593|NCT00196976|FG002|Participant Flow|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837594|NCT00196976|FG003|Participant Flow|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837595|NCT00196976|FG004|Participant Flow|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837596|NCT00196976|FG005|Participant Flow|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837597|NCT00196976|FG006|Participant Flow|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837598|NCT00196976|FG007|Participant Flow|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837599|NCT00196976|FG008|Participant Flow|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837600|NCT00196976|FG009|Participant Flow|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837601|NCT00196976|FG010|Participant Flow|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837602|NCT00196976|FG011|Participant Flow|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837603|NCT00196976|FG012|Participant Flow|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
10837604|NCT00196976|FG013|Participant Flow|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
10837605|NCT00196976|OG000|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837606|NCT00196976|OG001|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837607|NCT00196976|OG002|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837608|NCT00196976|OG003|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837609|NCT00196976|OG004|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837610|NCT00196976|OG005|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837611|NCT00196976|OG006|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837612|NCT00196976|OG007|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837613|NCT00196976|OG008|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837614|NCT00196976|OG009|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837615|NCT00196976|OG005|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837616|NCT00196976|OG006|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837617|NCT00196976|OG007|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837618|NCT00196976|OG008|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837619|NCT00196976|OG009|Outcome|Control (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837620|NCT00196976|OG000|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837621|NCT00196976|OG001|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837622|NCT00196976|OG002|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837623|NCT00196976|OG003|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837624|NCT00196976|OG004|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837625|NCT00196976|OG000|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837626|NCT00196976|OG001|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837627|NCT00196976|OG002|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
10837628|NCT00196976|OG003|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
10837629|NCT00196976|EG000|Reported Event|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837630|NCT00196976|EG001|Reported Event|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837631|NCT00196976|EG002|Reported Event|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837632|NCT00196976|EG003|Reported Event|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837633|NCT00196976|EG004|Reported Event|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
10837634|NCT00196976|EG005|Reported Event|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837635|NCT00196976|EG006|Reported Event|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837636|NCT00196976|EG007|Reported Event|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837637|NCT00196976|EG008|Reported Event|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
10837638|NCT00196976|EG009|Reported Event|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
10837639|NCT00196976|EG010|Reported Event|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837640|NCT00196976|EG011|Reported Event|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
10837641|NCT00196976|EG012|Reported Event|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
10837642|NCT00196976|EG013|Reported Event|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
10837643|NCT00197002|BG000|Baseline|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
10837644|NCT00197002|BG001|Baseline|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
10837645|NCT00197002|BG002|Baseline|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837646|NCT00197002|BG003|Baseline|Total|Total of all reporting groups
10837647|NCT00197002|FG000|Participant Flow|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
10837648|NCT00197002|FG001|Participant Flow|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
10837649|NCT00197002|FG002|Participant Flow|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837650|NCT00197002|OG000|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
10837651|NCT00197002|OG001|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
10837652|NCT00197002|OG000|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
10837653|NCT00197002|OG001|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837654|NCT00197002|OG000|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837655|NCT00197002|OG002|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837656|NCT00197002|EG000|Reported Event|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
10837657|NCT00197002|EG001|Reported Event|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
10837658|NCT00197002|EG002|Reported Event|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
10837659|NCT00197015|BG000|Baseline|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
10837660|NCT00197015|BG001|Baseline|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
10837661|NCT00197015|BG002|Baseline|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
10837662|NCT00197015|BG003|Baseline|Total|Total of all reporting groups
10837663|NCT00197015|FG000|Participant Flow|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
10837664|NCT00197015|FG001|Participant Flow|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
10837665|NCT00197015|FG002|Participant Flow|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
10837666|NCT00197015|OG000|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
10837667|NCT00197015|OG001|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
10837668|NCT00197015|OG002|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
10837669|NCT00197015|EG000|Reported Event|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
10837670|NCT00197015|EG001|Reported Event|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
10837671|NCT00197015|EG002|Reported Event|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
10837672|NCT00197028|BG000|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837673|NCT00197028|BG001|Baseline|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837674|NCT00197028|BG002|Baseline|Total|Total of all reporting groups
10837675|NCT00197028|FG000|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837676|NCT00197028|FG001|Participant Flow|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837677|NCT00197028|OG000|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837678|NCT00197028|OG001|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837679|NCT00197028|EG000|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837680|NCT00197028|EG001|Reported Event|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10837681|NCT00197054|BG000|Baseline|RTS, S/AS02A|RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837682|NCT00197054|BG001|Baseline|RTS, S/AS01B|RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837683|NCT00197054|BG002|Baseline|Rabipur (Rabies) Vaccine|Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
10837684|NCT00197054|BG003|Baseline|Total|Total of all reporting groups
10837685|NCT00197054|FG000|Participant Flow|RTS, S/AS02A|RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837686|NCT00197054|FG001|Participant Flow|RTS, S/AS01B|RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837687|NCT00197054|FG002|Participant Flow|Rabipur (Rabies) Vaccine|Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
10837688|NCT00197054|OG000|Outcome|RTS, S/AS02A|RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837689|NCT00197054|OG001|Outcome|RTS, S/AS01B|RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837690|NCT00197054|OG000|Outcome|RTS, S/AS01B|RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837691|NCT00197054|OG001|Outcome|RTS, S/AS02A|RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837692|NCT00197054|OG002|Outcome|Rabipur (Rabies) Vaccine|Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
10837693|NCT00197054|OG002|Outcome|Rabipur (Rabies) Vaccine|Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
10837694|NCT00197054|OG000|Outcome|>=3.3 MIU/ML|Seropositive: >3.3 mlU/mL
10837695|NCT00197054|OG001|Outcome|>=10 MIU/ML|Seroprotected: >10 mlU/mL
10837696|NCT00197054|OG000|Outcome|Geometric Mean Antibody|Geometric Mean Antibody titer calculated on all subjects
10837697|NCT00197054|OG000|Outcome|Geometric Mean Antibody Titer|GMTs calculated on all subjects
10837698|NCT00197054|OG000|Outcome|Seropositive|Seropositive: >0.5 EU/mL
10837699|NCT00197054|OG000|Outcome|RTS, S/AS01B|RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
10837700|NCT00197054|OG001|Outcome|RTS, S/AS02A|RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
10837701|NCT00197054|EG000|Reported Event|(RTS, S/AS01B)|"RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.~RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months."
10837702|NCT00197054|EG001|Reported Event|(RTS, S/AS02A)|"RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.~RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months."
10837703|NCT00197054|EG002|Reported Event|Rabipur (Rabies) Vaccine|"Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months~Rabipur (Rabies) Vaccine: .0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months"
10837704|NCT00197106|BG000|Baseline|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
10837705|NCT00197106|BG001|Baseline|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
10837706|NCT00197106|BG002|Baseline|Total|Total of all reporting groups
10837707|NCT00197106|FG000|Participant Flow|Fluticasone Propionate (FP) 100 mcg|Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
10837708|NCT00197106|FG001|Participant Flow|Salmeterol/FP 50/100 mcg Plus Placebo|One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
10837709|NCT00197106|FG002|Participant Flow|FP 200 mcg|FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
10837710|NCT00197106|OG000|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
10837711|NCT00197106|OG001|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
10837712|NCT00197106|EG000|Reported Event|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
10837713|NCT00197106|EG001|Reported Event|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
10837714|NCT00197119|BG000|Baseline|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
10837715|NCT00197119|BG001|Baseline|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
10837716|NCT00197119|BG002|Baseline|Total|Total of all reporting groups
10837717|NCT00197119|FG000|Participant Flow|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
10837718|NCT00197119|FG001|Participant Flow|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
10837719|NCT00197119|OG000|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
10837720|NCT00197119|OG001|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
10837721|NCT00197119|EG000|Reported Event|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
10837722|NCT00197119|EG001|Reported Event|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
10837723|NCT00197145|BG000|Baseline|APL + OBT|Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10843316|NCT00253643|FG002|Participant Flow|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
10837724|NCT00197145|BG001|Baseline|Placebo + OBT|Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837725|NCT00197145|BG002|Baseline|Total|Total of all reporting groups
10837726|NCT00197145|FG000|Participant Flow|APL + OBT|Participants were administered APL tablets orally as 400 milligram (mg) twice daily (BID) for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (lopinavir [LPV]/RTV) was counted as one drug.
10837727|NCT00197145|FG001|Participant Flow|Placebo + OBT|Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (lopinavir [LPV]/RTV) was counted as one drug.
10837728|NCT00197145|OG000|Outcome|APL + OBT|Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837729|NCT00197145|OG001|Outcome|Placebo + OBT|Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837730|NCT00197145|OG000|Outcome|APL + OBT|Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837731|NCT00197145|EG000|Reported Event|APL + OBT|Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837732|NCT00197145|EG001|Reported Event|Placebo + OBT|Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of >400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs [lamivudine and zidovudine], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
10837733|NCT00197184|BG000|Baseline|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
10837734|NCT00197184|BG001|Baseline|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
10837735|NCT00197184|BG002|Baseline|Total|Total of all reporting groups
10837736|NCT00197184|FG000|Participant Flow|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
10837737|NCT00197184|FG001|Participant Flow|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
10837738|NCT00197184|OG000|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
10837739|NCT00197184|OG001|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
10837740|NCT00197184|EG000|Reported Event|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
10837741|NCT00197184|EG001|Reported Event|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
10837742|NCT00197236|BG000|Baseline|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
10837743|NCT00197236|BG001|Baseline|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
10837744|NCT00197236|BG002|Baseline|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
10837745|NCT00197236|BG003|Baseline|Total|Total of all reporting groups
10837746|NCT00197236|FG000|Participant Flow|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
10837747|NCT00197236|FG001|Participant Flow|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
10837748|NCT00197236|FG002|Participant Flow|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
10837749|NCT00197236|OG000|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
10837750|NCT00197236|OG001|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
10837751|NCT00197236|OG002|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
10837752|NCT00197236|OG000|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
10837753|NCT00197236|OG001|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
10837754|NCT00197236|OG002|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
10837755|NCT00197236|EG000|Reported Event|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
10837756|NCT00197236|EG001|Reported Event|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
10837757|NCT00197236|EG002|Reported Event|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
10837758|NCT00197392|BG000|Baseline|Bactiseal EVD|
10837759|NCT00197392|BG001|Baseline|Standard EVD|
10837760|NCT00197392|BG002|Baseline|Total|Total of all reporting groups
10837761|NCT00197392|FG000|Participant Flow|Bactiseal EVD|Subjects treated with Bactiseal EVD catheter
10837762|NCT00197392|FG001|Participant Flow|Conventional EVD Catheter|Subjects treated with Standard EVD catheter
10837763|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
10837764|NCT00197392|OG001|Outcome|Standard EVD Cathter|Patients treated with Standard EVD Catheter
10837765|NCT00197392|OG001|Outcome|Standard EVD Catheter|Patients treated with standard EVD catheter.
10837766|NCT00197392|OG000|Outcome|Bactiseal - EVD Catheter|Patients treated with Bactiseal EVD catheter
10837767|NCT00197392|OG001|Outcome|Standard EVD Catheter|Patient treated with Standard EVD Catheter
10837768|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
10837769|NCT00197392|OG001|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
10837770|NCT00197392|OG001|Outcome|Standard EVD Catheter|Patients implanted with standard EVD catheter
10837771|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
10837772|NCT00197392|OG001|Outcome|Standard EVD Catheter|Subjects implanted with standard EVD catheter
10837773|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter and Standard EVD Cathter|Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.
10837774|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter|Subjects treated with Bactiseal EVD Catheter
10837775|NCT00197392|OG001|Outcome|Standard EVD Catheter|Subjects treated with standard EVD catheter
10837776|NCT00197392|OG001|Outcome|Standrad EVD Catheter|Subjects implanted with standard EVD catheter
10837777|NCT00197392|OG000|Outcome|Bactiseal EVD Catheter|Subjects implanted with the Bactiseal EVD Catheter
10837778|NCT00197392|OG001|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
10837779|NCT00197392|OG000|Outcome|Bactiseal EVD|Subjects implanted with Bactiseal EVD catheters.
10837780|NCT00197392|OG001|Outcome|Standard EVD|Subjects implanted with Standard EVD catheters.
10837781|NCT00197392|EG000|Reported Event|Standard EVD|Subjects with standard EVD
10837782|NCT00197392|EG001|Reported Event|Bactiseal EVD|Subjects with Bactiseal EVD
10837783|NCT00197496|BG000|Baseline|BWSTT|Body weight supported treadmill training
10837784|NCT00197496|BG001|Baseline|Control|Usual care
10837785|NCT00197496|BG002|Baseline|Total|Total of all reporting groups
10837786|NCT00197496|FG000|Participant Flow|BWSTT|Body weight supported treadmill training
10837787|NCT00197496|FG001|Participant Flow|Control|Usual care
10837788|NCT00197496|OG000|Outcome|BWSTT|Body weight supported treadmill training
10837789|NCT00197496|OG001|Outcome|Control|Usual care
10837790|NCT00197496|EG000|Reported Event|BWSTT|Body weight supported treadmill training: hip fracture patients walk on a treadmill with body weight support
10837791|NCT00197496|EG001|Reported Event|Usual Care|Usual care rehabilitation
10837792|NCT00198029|BG000|Baseline|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
10837793|NCT00198029|FG000|Participant Flow|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
10837794|NCT00198029|OG000|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
10837795|NCT00198029|EG000|Reported Event|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
10837796|NCT00198042|BG000|Baseline|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
10837797|NCT00198042|FG000|Participant Flow|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
10837798|NCT00198042|OG000|Outcome|All Patients|Tunnel expansion after ACL-R occurs early and primarily at the tunnel apertures. Expansion may not affect clinical outcome. Younger age, male sex, and delay from injury to ACL-R may be potential risks for enlargement.
10837799|NCT00198042|EG000|Reported Event|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
10837800|NCT00198081|BG000|Baseline|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837801|NCT00198081|BG001|Baseline|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
10837802|NCT00198081|BG002|Baseline|Total|Total of all reporting groups
10837803|NCT00198081|FG000|Participant Flow|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837804|NCT00198081|FG001|Participant Flow|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
10837805|NCT00198081|OG000|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837806|NCT00198081|OG001|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837807|NCT00198081|OG002|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837808|NCT00198081|OG003|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837809|NCT00198081|OG004|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837810|NCT00198081|OG000|Outcome|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837811|NCT00198081|OG001|Outcome|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
10837812|NCT00198081|EG000|Reported Event|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
10837813|NCT00198081|EG001|Reported Event|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
10837814|NCT00198107|BG000|Baseline|1 Placebo|"Participants will take placebo~Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment."
10837815|NCT00198107|BG001|Baseline|2 Aripiprazole|"Participants will take aripiprazole~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg."
10837816|NCT00198107|BG002|Baseline|Total|Total of all reporting groups
10837817|NCT00198107|FG000|Participant Flow|1 Placebo|"Participants will take placebo~Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment."
10837818|NCT00198107|FG001|Participant Flow|2 Aripiprazole|"Participants will take aripiprazole~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg."
10837819|NCT00198107|FG002|Participant Flow|3 Aripiprazole + D-cycloserine|"Participants first will take aripiprazole then will also take D-cycloserine~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.~D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment."
10837820|NCT00198107|OG000|Outcome|1 Placebo|"Participants will take placebo~Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment."
10837821|NCT00198107|OG001|Outcome|2 Aripiprazole|"Participants will take aripiprazole~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg."
10837822|NCT00198107|OG002|Outcome|3 Aripiprazole + D-cycloserine|"Participants first will take aripiprazole then will also take D-cycloserine~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.~D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment."
10837823|NCT00198107|EG000|Reported Event|1 Placebo|"Participants will take placebo~Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment."
10837824|NCT00198107|EG001|Reported Event|2 Aripiprazole|"Participants will take aripiprazole~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg."
10837825|NCT00198107|EG002|Reported Event|3 Aripiprazole + D-cycloserine|"Participants first will take aripiprazole then will also take D-cycloserine~Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.~D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment."
10837826|NCT00198133|BG000|Baseline|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837827|NCT00198133|BG001|Baseline|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837828|NCT00198133|BG002|Baseline|Total|Total of all reporting groups
10837829|NCT00198133|FG000|Participant Flow|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837830|NCT00198133|FG001|Participant Flow|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837831|NCT00198133|OG000|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837832|NCT00198133|OG001|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837833|NCT00198133|EG000|Reported Event|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837834|NCT00198133|EG001|Reported Event|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
10837835|NCT00198822|BG000|Baseline|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
10837836|NCT00198822|BG001|Baseline|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
10837837|NCT00198822|BG002|Baseline|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
10837838|NCT00198822|BG003|Baseline|Total|Total of all reporting groups
10837839|NCT00198822|FG000|Participant Flow|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
10837840|NCT00198822|FG001|Participant Flow|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
10837841|NCT00198822|FG002|Participant Flow|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
10837842|NCT00198822|OG000|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
10837843|NCT00198822|OG001|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
10837844|NCT00198822|OG002|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
10837845|NCT00198822|EG000|Reported Event|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
10837846|NCT00198822|EG001|Reported Event|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
10837847|NCT00198822|EG002|Reported Event|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
10837848|NCT00199381|BG000|Baseline|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
10837849|NCT00199381|FG000|Participant Flow|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
10837850|NCT00199381|OG000|Outcome|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
10837851|NCT00199381|EG000|Reported Event|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
10842896|NCT00250276|EG004|Reported Event|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
10842897|NCT00250432|BG000|Baseline|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
10842898|NCT00250432|BG001|Baseline|Caspofungin 150 mg|Caspofungin 150 mg IV daily
10837852|NCT00199797|BG000|Baseline|huA33 Antibody Plus Chemotherapy|"huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.~Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.~Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.~The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.~A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression."
10837853|NCT00199797|FG000|Participant Flow|huA33 Antibody Plus Chemotherapy|"huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.~Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.~Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.~The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.~A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression."
10837854|NCT00199797|OG000|Outcome|huA33 Antibody Plus Chemotherapy|"huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.~Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.~Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.~The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.~A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression."
10837855|NCT00199797|OG000|Outcome|huA33 Antibody Plus Chemotherapy|"huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.~Starting on day 15 and continuing every second week, oxaliplatin,5-fluorouracil (5-FU) and leucovorin were also administered.~Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.~The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.~A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression."
10837856|NCT00199797|EG000|Reported Event|huA33 Antibody Plus Chemotherapy|"huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.~Starting on day 15 and continuing every second week, oxaliplatin,5-fluorouracil (5-FU) and leucovorin were also administered.~Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.~The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.~A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression."
10837857|NCT00199836|BG000|Baseline|Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.|NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.
10837858|NCT00199836|FG000|Participant Flow|Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.|NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.
10837859|NCT00199836|OG000|Outcome|Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.|NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
10837860|NCT00199836|OG000|Outcome|Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.|NY-ESO-1b peptide, 100 μg mixed with 1mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
10837861|NCT00199836|EG000|Reported Event|Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.|NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection of peptide. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
10837862|NCT00199849|BG000|Baseline|Cohort 1|"4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10842899|NCT00250432|BG002|Baseline|Total|Total of all reporting groups
10837863|NCT00199849|BG001|Baseline|Cohort 2|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837864|NCT00199849|BG002|Baseline|Cohort 3|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day.~The vaccine was administered in weeks 1, 5, and 9."
10837865|NCT00199849|BG003|Baseline|Total|Total of all reporting groups
10837866|NCT00199849|FG000|Participant Flow|Cohort 1|"4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 4 µg dosage of Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs in close proximity.~The vaccine was administered in weeks 1, 5, and 9."
10837867|NCT00199849|FG001|Participant Flow|Cohort 2|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837868|NCT00199849|FG002|Participant Flow|Cohort 3|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day.~The vaccine was administered in weeks 1, 5, and 9."
10837869|NCT00199849|OG000|Outcome|Cohort 1|"4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837870|NCT00199849|OG001|Outcome|Cohort 2|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837871|NCT00199849|OG002|Outcome|Cohort 3|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day.~The vaccine was administered in weeks 1, 5, and 9."
10837872|NCT00199849|EG000|Reported Event|Cohort 1|"4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837873|NCT00199849|EG001|Reported Event|Cohort 2|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs.~The vaccine was administered in weeks 1, 5, and 9."
10837874|NCT00199849|EG002|Reported Event|Cohort 3|"8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine~NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.~The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day.~The vaccine was administered in weeks 1, 5, and 9."
10837875|NCT00199875|BG000|Baseline|Cohort 1 (0.2 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.2 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837876|NCT00199875|BG001|Baseline|Cohort 2 (0.3 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.3 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837877|NCT00199875|BG002|Baseline|Cohort 3 (0.4 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.4 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837878|NCT00199875|BG003|Baseline|Cohort 4 (0.45 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.45 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837879|NCT00199875|BG004|Baseline|Cohort 5 (0.55 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.55 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837880|NCT00199875|BG005|Baseline|Total|Total of all reporting groups
10837881|NCT00199875|FG000|Participant Flow|Cohort 1 (0.2 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.2 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837882|NCT00199875|FG001|Participant Flow|Cohort 2 (0.3 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.3 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837883|NCT00199875|FG002|Participant Flow|Cohort 3 (0.4 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.4 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837884|NCT00199875|FG003|Participant Flow|Cohort 4 (0.45 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.45 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837885|NCT00199875|FG004|Participant Flow|Cohort 5 (0.55 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.55 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837886|NCT00199875|OG000|Outcome|Cohort 1 (0.2 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.2 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837887|NCT00199875|OG001|Outcome|Cohort 2 (0.3 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.3 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837888|NCT00199875|OG002|Outcome|Cohort 3 (0.4 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.4 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837889|NCT00199875|OG003|Outcome|Cohort 4 (0.45 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.45 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837890|NCT00199875|OG004|Outcome|Cohort 5 (0.55 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.55 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837891|NCT00199875|EG000|Reported Event|Cohort 1 (0.2 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.2 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837892|NCT00199875|EG001|Reported Event|Cohort 2 (0.3 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.3 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837893|NCT00199875|EG002|Reported Event|Cohort 3 (0.4 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.4 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837894|NCT00199875|EG003|Reported Event|Cohort 4 (0.45 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.45 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837895|NCT00199875|EG004|Reported Event|Cohort 5 (0.55 mCi/kg)|Patients initially received a nontherapeutic injection of ^111In-DOTA-cG250 (5 mCi ^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic ^90Y-DOTA-cG250 (0.55 mCi/kg ^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.
10837896|NCT00199888|BG000|Baseline|124-Iodine-cG250 (124I-cG250)|Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
10837897|NCT00199888|FG000|Participant Flow|124-Iodine-cG250 (124I-cG250)|Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi)/10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
10842900|NCT00250432|FG000|Participant Flow|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
10837898|NCT00199888|OG000|Outcome|124-Iodine-cG250 (124I-cG250)|Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.
10837899|NCT00199888|EG000|Reported Event|124-Iodine-cG250 (124I-cG250)|Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.
10837900|NCT00199901|BG000|Baseline|NY-ESO-1 ISCOMATRIX® Vaccine|"100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.~Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days)."
10837901|NCT00199901|BG001|Baseline|ISCOMATRIX® Adjuvant|"120 μg of ISCOMATRIX® adjuvant.~Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days)."
10837902|NCT00199901|BG002|Baseline|Total|Total of all reporting groups
10837903|NCT00199901|FG000|Participant Flow|NY-ESO-1 ISCOMATRIX® Vaccine|100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837904|NCT00199901|FG001|Participant Flow|ISCOMATRIX® Adjuvant|120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837905|NCT00199901|OG000|Outcome|NY-ESO-1 ISCOMATRIX® Vaccine|"100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.~Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days)."
10837906|NCT00199901|OG001|Outcome|ISCOMATRIX® Adjuvant|"120 μg of ISCOMATRIX® adjuvant.~Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days)."
10837907|NCT00199901|OG000|Outcome|NY-ESO-1 ISCOMATRIX® Vaccine|100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837908|NCT00199901|OG001|Outcome|ISCOMATRIX® Adjuvant|120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837909|NCT00199901|EG000|Reported Event|NY-ESO-1 ISCOMATRIX® Vaccine|100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837910|NCT00199901|EG001|Reported Event|ISCOMATRIX® Adjuvant|120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).
10837911|NCT00199914|BG000|Baseline|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837912|NCT00199914|BG001|Baseline|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837913|NCT00199914|BG002|Baseline|Total|Total of all reporting groups
10837914|NCT00199914|FG000|Participant Flow|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837915|NCT00199914|FG001|Participant Flow|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837916|NCT00199914|OG000|Outcome|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837917|NCT00199914|OG001|Outcome|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837918|NCT00199914|EG000|Reported Event|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837919|NCT00199914|EG001|Reported Event|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
10837920|NCT00200057|BG000|Baseline|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
10837921|NCT00200057|FG000|Participant Flow|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
10837922|NCT00200057|OG000|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
10837923|NCT00200057|EG000|Reported Event|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
10837924|NCT00200161|BG000|Baseline|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837925|NCT00200161|BG001|Baseline|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837926|NCT00200161|BG002|Baseline|Total|Total of all reporting groups
10842901|NCT00250432|FG001|Participant Flow|Caspofungin 150 mg|Caspofungin 150 mg IV daily
10837927|NCT00200161|FG000|Participant Flow|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837928|NCT00200161|FG001|Participant Flow|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837929|NCT00200161|OG000|Outcome|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837930|NCT00200161|OG001|Outcome|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837931|NCT00200161|EG000|Reported Event|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837932|NCT00200161|EG001|Reported Event|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
10837933|NCT00200343|BG000|Baseline|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
10837934|NCT00200343|BG001|Baseline|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
10837935|NCT00200343|BG002|Baseline|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
10837936|NCT00200343|BG003|Baseline|Total|Total of all reporting groups
10837937|NCT00200343|FG000|Participant Flow|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
10837938|NCT00200343|FG001|Participant Flow|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
10837939|NCT00200343|FG002|Participant Flow|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
10837940|NCT00200343|OG000|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
10837941|NCT00200343|OG001|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
10837942|NCT00200343|OG002|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
10837943|NCT00200343|EG000|Reported Event|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
10837944|NCT00200343|EG001|Reported Event|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
10837945|NCT00200343|EG002|Reported Event|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
10837946|NCT00200356|BG000|Baseline|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
10837947|NCT00200356|BG001|Baseline|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
10837948|NCT00200356|BG002|Baseline|Total|Total of all reporting groups
10837949|NCT00200356|FG000|Participant Flow|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
10837950|NCT00200356|FG001|Participant Flow|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
10837951|NCT00200356|OG000|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
10837952|NCT00200356|OG001|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
10837953|NCT00200356|EG000|Reported Event|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
10837954|NCT00200356|EG001|Reported Event|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
10837955|NCT00200785|BG000|Baseline|Garlic Powder: High Allicin|garlic powder in ambient water
10837956|NCT00200785|BG001|Baseline|Garlic Powder: No Allicin|garlic powder in boiling water
10837957|NCT00200785|BG002|Baseline|Total|Total of all reporting groups
10837958|NCT00200785|FG000|Participant Flow|Garlic Powder: High Allicin|garlic powder in ambient water
10837959|NCT00200785|FG001|Participant Flow|Garlic Powder: No Allicin|garlic powder in boiling water
10837960|NCT00200785|OG000|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
10837961|NCT00200785|OG001|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
10837962|NCT00200785|EG000|Reported Event|Garlic Powder: High Allicin|garlic powder in ambient water
10837963|NCT00200785|EG001|Reported Event|Garlic Powder: No Allicin|garlic powder in boiling water
10837964|NCT00200850|BG000|Baseline|Low Dose|"Low dose SLIT~Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily"
10837965|NCT00200850|BG001|Baseline|High Dose|"High dose SLIT~High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily"
10837966|NCT00200850|BG002|Baseline|Placebo|"Placebo~Placebo SLIT: Placebo SLIT daily"
10837967|NCT00200850|BG003|Baseline|Total|Total of all reporting groups
10837968|NCT00200850|FG000|Participant Flow|Low Dose|"Low dose SLIT~Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily"
10837969|NCT00200850|FG001|Participant Flow|High Dose|"High dose SLIT~High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily"
10837970|NCT00200850|FG002|Participant Flow|Placebo|"Placebo~Placebo SLIT: Placebo SLIT daily"
10837971|NCT00200850|OG000|Outcome|Low Dose|"Low dose SLIT~Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily"
10837972|NCT00200850|OG001|Outcome|High Dose|"High dose SLIT~High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily"
10837973|NCT00200850|OG002|Outcome|Placebo|"Placebo~Placebo SLIT: Placebo SLIT daily"
10837974|NCT00200850|EG000|Reported Event|Low Dose|"Low dose SLIT~Hose Dust Mite SLIT: low dose SLIT 143 AU/ml daily"
10837975|NCT00200850|EG001|Reported Event|High Dose|"High dose SLIT~High dose SLIT: House Dust Mite SLIT- 10,000 AU/ml daily"
10837976|NCT00200850|EG002|Reported Event|Placebo|"Placebo~Placebo SLIT: Placebo SLIT daily"
10837977|NCT00200902|BG000|Baseline|Medication Treatment (MED)|MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)
10837978|NCT00200902|BG001|Baseline|Placebo|
10837979|NCT00200902|BG002|Baseline|Interpersonal Clinical Interaction|Subjects assigned to the interpersonal clinical interaction (ICI). Visits involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
10837980|NCT00200902|BG003|Baseline|Total|Total of all reporting groups
10837981|NCT00200902|FG000|Participant Flow|MEDS + ICI|MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)
10837982|NCT00200902|FG001|Participant Flow|Placebo+ICI|
10837983|NCT00200902|FG002|Participant Flow|ICI Alone|Subjects assigned to the interpersonal clinical interaction (ICI). Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
10837984|NCT00200902|OG000|Outcome|MEDICATIONS|Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).
10837985|NCT00200902|OG001|Outcome|Placebo (PBO)|Interpersonal clinical interaction (ICI) plus placebo
10837986|NCT00200902|OG002|Outcome|Interpersonal Clinical Interaction (ICI)|Interpersonal clinical interaction (ICI) ONLY
10837987|NCT00200902|OG000|Outcome|Medication (MED)|MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)
10837988|NCT00200902|OG001|Outcome|Placebo (PBO)|"Placebo subjects received interpersonal clinical interaction (ICI) along with placebo treatment.~Placebo: Subjects assigned to the placebo (PBO) or medication (MED) condition entered double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They underwent the same schedule, structure, and intensity of visits as in the ICI condition, but also were randomized to receive treatment with a pill. Subjects randomized to medication started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well."
10837989|NCT00200902|OG002|Outcome|Interpersonal Clinical Interaction (ICI)|Interpersonal Clinical Interaction (ICI) ONLY
10837990|NCT00200902|OG000|Outcome|Medication (MED)|Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI
10837991|NCT00200902|OG001|Outcome|Placebo (PBO)|Placebo + ICI
10837992|NCT00200902|OG002|Outcome|Interpersonal Clinical Interaction (ICI)|ICI ONLY
10837993|NCT00200902|EG000|Reported Event|Medication|Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI
10837994|NCT00200902|EG001|Reported Event|Placebo (PBO)|Placebo + ICI
10837995|NCT00200902|EG002|Reported Event|Interpersonal Clinical Interaction (ICI)|ICI ONLY
10837996|NCT00200967|BG000|Baseline|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10837997|NCT00200967|BG001|Baseline|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10837998|NCT00200967|BG002|Baseline|Total|Total of all reporting groups
10837999|NCT00200967|FG000|Participant Flow|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10838000|NCT00200967|FG001|Participant Flow|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10838001|NCT00200967|OG000|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10838002|NCT00200967|OG001|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10842902|NCT00250432|OG000|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
10838003|NCT00200967|EG000|Reported Event|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10838004|NCT00200967|EG001|Reported Event|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
10838005|NCT00201006|BG000|Baseline|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
10838006|NCT00201006|BG001|Baseline|Telephone Counseling|26 biweekly telephone counseling sessions
10838007|NCT00201006|BG002|Baseline|Mail Contact|26 biweekly newsletters with weight management advice
10838008|NCT00201006|BG003|Baseline|Total|Total of all reporting groups
10838009|NCT00201006|FG000|Participant Flow|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
10838010|NCT00201006|FG001|Participant Flow|Telephone Counseling|26 biweekly telephone counseling sessions
10838011|NCT00201006|FG002|Participant Flow|Mail Contact|26 biweekly newsletters with weight management advice
10838012|NCT00201006|OG000|Outcome|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
10838013|NCT00201006|OG001|Outcome|Telephone Counseling|26 biweekly telephone counseling sessions
10838014|NCT00201006|OG002|Outcome|Mail Contact|26 biweekly newsletters with weight management advice
10838015|NCT00201006|EG000|Reported Event|Face-to-face|received 26 biweekly office-based, face-to-face group counseling sessions
10838016|NCT00201006|EG001|Reported Event|Telephone|received 26 biweekly individual telephone counseling sessions
10838017|NCT00201006|EG002|Reported Event|Mail|received by mail 26 biweekly newsletters with weight management information
10838018|NCT00201123|BG000|Baseline|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
10838019|NCT00201123|BG001|Baseline|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
10838020|NCT00201123|BG002|Baseline|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
10838021|NCT00201123|BG003|Baseline|Total|Total of all reporting groups
10838022|NCT00201123|FG000|Participant Flow|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
10838023|NCT00201123|FG001|Participant Flow|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
10838024|NCT00201123|FG002|Participant Flow|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
10838025|NCT00201123|OG000|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
10838026|NCT00201123|OG001|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
10838027|NCT00201123|OG002|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
10838028|NCT00201123|OG002|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
10838029|NCT00201123|OG000|Outcome|DOTS|
10838030|NCT00201123|OG001|Outcome|Nebulized rlFN-y|
10838031|NCT00201123|OG002|Outcome|Subcutaneous rlFN-y|
10838032|NCT00201123|EG000|Reported Event|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
10838033|NCT00201123|EG001|Reported Event|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
10838034|NCT00201123|EG002|Reported Event|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
10838035|NCT00201201|BG000|Baseline|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program."
10838036|NCT00201201|BG001|Baseline|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
10838037|NCT00201201|BG002|Baseline|Total|Total of all reporting groups
10838038|NCT00201201|FG000|Participant Flow|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
10838039|NCT00201201|FG001|Participant Flow|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
10842903|NCT00250432|OG001|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
10842904|NCT00250432|EG000|Reported Event|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
10842905|NCT00250432|EG001|Reported Event|Caspofungin 150 mg|Caspofungin 150 mg IV daily
10838040|NCT00201201|OG000|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
10838041|NCT00201201|OG001|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
10838042|NCT00201201|EG000|Reported Event|Education|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension will be randomized to usual care and intervention groups. Both groups will enter medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The intervention group will receive a tailored education program."
10838043|NCT00201201|EG001|Reported Event|Control|Control group without education intervention.
10838044|NCT00201240|BG000|Baseline|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
10838045|NCT00201240|FG000|Participant Flow|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
10838046|NCT00201240|OG000|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
10838047|NCT00201240|OG000|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
10838048|NCT00201240|EG000|Reported Event|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
10838049|NCT00201409|BG000|Baseline|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
10838050|NCT00201409|BG001|Baseline|Placebo Group|Participants will be randomized to receive placebo.
10838051|NCT00201409|BG002|Baseline|Total|Total of all reporting groups
10838052|NCT00201409|FG000|Participant Flow|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
10838053|NCT00201409|FG001|Participant Flow|Placebo Group|Participants will be randomized to receive placebo.
10838054|NCT00201409|OG000|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
10838055|NCT00201409|OG001|Outcome|Placebo Group|Participants will be randomized to receive placebo.
10838056|NCT00201409|EG000|Reported Event|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
10838057|NCT00201409|EG001|Reported Event|Placebo Group|Participants will be randomized to receive placebo.
10838058|NCT00201448|BG000|Baseline|Placebo (Hepatitis A)|
10838059|NCT00201448|BG001|Baseline|Towne CMV Vaccine|
10838060|NCT00201448|BG002|Baseline|Total|Total of all reporting groups
10838061|NCT00201448|FG000|Participant Flow|Placebo (Hepatitis A)|
10838062|NCT00201448|FG001|Participant Flow|Towne CMV Vaccine|
10838063|NCT00201448|OG000|Outcome|(Placebo) Hepatitis a|This is the comparator group.
10838064|NCT00201448|OG001|Outcome|Towne CMV Vaccine|
10838065|NCT00201448|OG000|Outcome|Placebo (Hepatitis A)|"Placebo group~Hepatitis A Vaccine: Single dose give IM"
10838066|NCT00201448|OG001|Outcome|Towne Vaccine|"Towne vaccine given at 3000 pfu/subject~Towne CMV Vaccine: Single dose given subcutaneously"
10838067|NCT00201448|EG000|Reported Event|Placebo (Hepatitis A)|
10838068|NCT00201448|EG001|Reported Event|Towne CMV Vaccine|
10842906|NCT00250484|BG000|Baseline|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842907|NCT00250484|BG001|Baseline|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842908|NCT00250484|BG002|Baseline|Total|Total of all reporting groups
10842909|NCT00250484|FG000|Participant Flow|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842910|NCT00250484|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842911|NCT00250484|OG000|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842912|NCT00250484|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842913|NCT00250484|EG000|Reported Event|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842914|NCT00250484|EG001|Reported Event|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
10842915|NCT00250497|BG000|Baseline|Intervention Group|New Moves Intervention
10842916|NCT00250497|BG001|Baseline|Control Group|All Girls PE Control Group
10842917|NCT00250497|BG002|Baseline|Total|Total of all reporting groups
10842918|NCT00250497|FG000|Participant Flow|Intervention Group|New Moves Intervention
10842919|NCT00250497|FG001|Participant Flow|Control Group|All Girls PE Control group
10842920|NCT00250497|OG000|Outcome|Intervention Group|New Moves Intervention Group
10842921|NCT00250497|OG001|Outcome|Control Group|All Girls PE Control Group
10838069|NCT00201643|BG000|Baseline|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
10838070|NCT00201643|BG001|Baseline|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
10838071|NCT00201643|BG002|Baseline|Total|Total of all reporting groups
10838072|NCT00201643|FG000|Participant Flow|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
10838073|NCT00201643|FG001|Participant Flow|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
10838074|NCT00201643|OG000|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
10838075|NCT00201643|OG001|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
10838076|NCT00201643|EG000|Reported Event|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
10838077|NCT00201643|EG001|Reported Event|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
10838078|NCT00201734|BG000|Baseline|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
10838079|NCT00201734|BG001|Baseline|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
10838080|NCT00201734|BG002|Baseline|Total|Total of all reporting groups
10838081|NCT00201734|FG000|Participant Flow|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
10838082|NCT00201734|FG001|Participant Flow|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
10838083|NCT00201734|OG000|Outcome|Phase I Patients|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
10838084|NCT00201734|OG000|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
10838085|NCT00201734|OG001|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
10838086|NCT00201734|EG000|Reported Event|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
10838087|NCT00201734|EG001|Reported Event|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
10838088|NCT00201760|BG000|Baseline|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
10838089|NCT00201760|BG001|Baseline|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
10838090|NCT00201760|BG002|Baseline|Total|Total of all reporting groups
10842922|NCT00250497|EG000|Reported Event|Intervention Group|New Moves Intervention Group
10842923|NCT00250497|EG001|Reported Event|Control Group|All Girls PE Control Group
10838091|NCT00201760|FG000|Participant Flow|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
10838092|NCT00201760|FG001|Participant Flow|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
10838093|NCT00201760|OG000|Outcome|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
10838094|NCT00201760|OG001|Outcome|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
10838095|NCT00201760|EG000|Reported Event|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
10838096|NCT00201760|EG001|Reported Event|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
10838097|NCT00201773|BG000|Baseline|Exemestane & Celecoxib|"Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.~Correlative studies"
10838098|NCT00201773|FG000|Participant Flow|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
10838099|NCT00201773|OG000|Outcome|Exemestane + Celecoxib|Exemestane + celecoxib (16 weeks) vs. Baseline
10838100|NCT00201773|OG001|Outcome|Exemestane|Exemestane (8 weeks) vs. Baseline
10838101|NCT00201773|OG000|Outcome|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
10838102|NCT00201773|EG000|Reported Event|Exemestane Alone|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
10838103|NCT00201773|EG001|Reported Event|Exemestane + Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
10838104|NCT00201825|BG000|Baseline|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
10838105|NCT00201825|FG000|Participant Flow|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
10838106|NCT00201825|OG000|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
10838107|NCT00201825|EG000|Reported Event|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
10838108|NCT00201838|BG000|Baseline|Interventional Arm|Patients received Etanercept with gemcitabine
10838109|NCT00201838|BG001|Baseline|Control Arm|Patients received Gemcitabine alone
10838110|NCT00201838|BG002|Baseline|Total|Total of all reporting groups
10838111|NCT00201838|FG000|Participant Flow|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
10838112|NCT00201838|FG001|Participant Flow|Control Group|Patients received gemcitabine alone
10838113|NCT00201838|OG000|Outcome|Experimental Group|Patients received etanercept 25mg subcutaneously twice-weekly with gemcitabine
10838114|NCT00201838|OG001|Outcome|Control Group|Patients received gemcitabine alone
10838115|NCT00201838|OG000|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
10838116|NCT00201838|OG000|Outcome|Experimental Group|Etanercept with gemcitabine
10838117|NCT00201838|OG001|Outcome|Control Group|Gemcitabine alone
10838118|NCT00201838|OG001|Outcome|Control Group|gemcitabine alone
10838119|NCT00201838|OG000|Outcome|Responders|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
10838120|NCT00201838|OG001|Outcome|Non Responders|"Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
10838121|NCT00201838|EG000|Reported Event|Experimental Group|Patients in the experimental group received etancercept 25 mg subcutaneously twice-weekly with gemcitabine.
10838122|NCT00201838|EG001|Reported Event|Control Group|Patients in the control cohort received gemcitabine alone.
10838123|NCT00201851|BG000|Baseline|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838124|NCT00201851|BG001|Baseline|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838125|NCT00201851|BG002|Baseline|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838126|NCT00201851|BG003|Baseline|Total|Total of all reporting groups
10838127|NCT00201851|FG000|Participant Flow|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838128|NCT00201851|FG001|Participant Flow|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838129|NCT00201851|FG002|Participant Flow|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838130|NCT00201851|OG000|Outcome|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838131|NCT00201851|OG001|Outcome|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838132|NCT00201851|OG002|Outcome|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838133|NCT00201851|EG000|Reported Event|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838134|NCT00201851|EG001|Reported Event|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838135|NCT00201851|EG002|Reported Event|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
10838136|NCT00201864|BG000|Baseline|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
10838137|NCT00201864|FG000|Participant Flow|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
10838138|NCT00201864|OG000|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
10838139|NCT00201864|OG000|Outcome|IGF-1|IGF-1-insulin-like growth factor
10838140|NCT00201864|OG001|Outcome|IGFBP-3|IGFBP-3-insulin-like growth factor-binding
10838141|NCT00201864|EG000|Reported Event|Single-arm Study|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
10838142|NCT00201877|BG000|Baseline|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
10838143|NCT00201877|FG000|Participant Flow|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
10838144|NCT00201877|OG000|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
10838145|NCT00201877|OG000|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14~Velcade: Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14.~Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23.~Rituximab: Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration.~Maintenance: 375 mg/m2 day 1 weekly x 4 weeks."
10838146|NCT00201877|EG000|Reported Event|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
10838147|NCT00202449|BG000|Baseline|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
10838148|NCT00202449|BG001|Baseline|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
10838149|NCT00202449|BG002|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10838150|NCT00202449|BG003|Baseline|Total|Total of all reporting groups
10838151|NCT00202449|FG000|Participant Flow|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
10838152|NCT00202449|FG001|Participant Flow|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
10838153|NCT00202449|FG002|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10838154|NCT00202449|OG000|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
10838155|NCT00202449|OG001|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
10838156|NCT00202449|OG002|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10838157|NCT00202449|EG000|Reported Event|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
10838158|NCT00202449|EG001|Reported Event|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
10838159|NCT00202449|EG002|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
10838160|NCT00202644|BG000|Baseline|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
10838161|NCT00202644|BG001|Baseline|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
10838162|NCT00202644|BG002|Baseline|Total|Total of all reporting groups
10838163|NCT00202644|FG000|Participant Flow|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
10838164|NCT00202644|FG001|Participant Flow|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
10838165|NCT00202644|OG000|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
10838166|NCT00202644|OG001|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
10838167|NCT00202644|EG000|Reported Event|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
10838168|NCT00202644|EG001|Reported Event|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
10838169|NCT00202722|BG000|Baseline|Women in Labour Given Remifentanil Analgesia|Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
10838170|NCT00202722|FG000|Participant Flow|Effect and Side Effects of Remifentanil|Analgesic efficacy and side offects of remifentanil during labour and delivery
10838171|NCT00202722|OG000|Outcome|Remifentanil|"Pain scores~Satisfaction"
10838172|NCT00202722|OG000|Outcome|Satisfaction With Remifentanil Analgesia|Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
10838173|NCT00202722|EG000|Reported Event|Maternal Oxygen Desaturation|Oxygen saturation lower than 92% during labour and delivery
10838174|NCT00202839|BG000|Baseline|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
10838175|NCT00202839|BG001|Baseline|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
10838176|NCT00202839|BG002|Baseline|Total|Total of all reporting groups
10838177|NCT00202839|FG000|Participant Flow|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
10838178|NCT00202839|FG001|Participant Flow|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
10838179|NCT00202839|OG000|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
10838180|NCT00202839|OG001|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
10838181|NCT00202839|EG000|Reported Event|24-Week Treatment|
10838182|NCT00202839|EG001|Reported Event|48-Week Treatment|
10838183|NCT00202930|BG000|Baseline|Rituximab|Participants received 4 weekly doses of IV rituxan at 375 mg/m^2 on days 1, 8, 15 and 22
10838184|NCT00202930|FG000|Participant Flow|Rituximab|Participants received 4 weekly doses of IV rituxan at 375 mg/m^2 on days 1, 8, 15 and 22
10838185|NCT00202930|OG000|Outcome|Rituximab|Participants received 4 weekly doses of IV rituxan at 375 mg/m^2 on days 1, 8, 15 and 22
10838186|NCT00202930|EG000|Reported Event|Rituximab|Participants received 4 weekly doses of IV rituxan at 375 mg/m^2 on days 1, 8, 15 and 22
10838187|NCT00203021|BG000|Baseline|Glatiramer Acetate: Delayed Start|Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838188|NCT00203021|BG001|Baseline|Glatiramer Acetate: Early Start|Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838189|NCT00203021|BG002|Baseline|Total|Total of all reporting groups
10838190|NCT00203021|FG000|Participant Flow|Glatiramer Acetate: Delayed Start|Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.
10838191|NCT00203021|FG001|Participant Flow|Glatiramer Acetate: Early Start|Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838192|NCT00203021|OG000|Outcome|Glatiramer Acetate: Delayed Start|Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838193|NCT00203021|OG001|Outcome|Glatiramer Acetate: Early Start|Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838194|NCT00203021|EG000|Reported Event|Glatiramer Acetate: Delayed Start|Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838195|NCT00203021|EG001|Reported Event|Glatiramer Acetate: Early Start|Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
10838196|NCT00203047|BG000|Baseline|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
10838197|NCT00203047|BG001|Baseline|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
10838198|NCT00203047|BG002|Baseline|Total|Total of all reporting groups
10838199|NCT00203047|FG000|Participant Flow|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
10838200|NCT00203047|FG001|Participant Flow|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
10838201|NCT00203047|OG000|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
10838202|NCT00203047|OG001|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
10838203|NCT00203047|EG000|Reported Event|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
10838204|NCT00203047|EG001|Reported Event|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
10838205|NCT00203203|BG000|Baseline|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
10838206|NCT00203203|BG001|Baseline|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
10838207|NCT00203203|BG002|Baseline|Total|Total of all reporting groups
10838208|NCT00203203|FG000|Participant Flow|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
10838209|NCT00203203|FG001|Participant Flow|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
10838210|NCT00203203|OG000|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
10838211|NCT00203203|OG001|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
10838212|NCT00203203|EG000|Reported Event|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
10838213|NCT00203203|EG001|Reported Event|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
10838214|NCT00203216|BG000|Baseline|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
10838215|NCT00203216|FG000|Participant Flow|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
11220387|NCT02333487|EG002|Reported Event|Lu AF35700 (Group 5-HT6)|"Lu AF35700: Cohort C1: Daily dosing with 10 mg for 21 days, Cohort C2: Daily dosing with 5 mg for 21 days, Cohort C3: Daily dosing with 5 mg for 7 days, and Cohort C4: Dosing with 5 mg for 4 days (Days 1, 3, 5, and 7).~5-HT6 (5-hydroxytryptamine-6) receptor occupancy using [11C]-Lu AE60157"
10838216|NCT00203216|OG000|Outcome|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
10838217|NCT00203216|EG000|Reported Event|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
10838218|NCT00203229|BG000|Baseline|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
10838219|NCT00203229|BG001|Baseline|Lamotrigine|The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
10838220|NCT00203229|BG002|Baseline|Total|Total of all reporting groups
10838221|NCT00203229|FG000|Participant Flow|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
10838222|NCT00203229|FG001|Participant Flow|Lamotrigine|The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
10838223|NCT00203229|OG000|Outcome|Placebo|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
10838224|NCT00203229|OG001|Outcome|Lamotrigine|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
10838225|NCT00203229|EG000|Reported Event|Placebo|Subjects who received placebo
10838226|NCT00203229|EG001|Reported Event|Lamotrigine|Subjects who received Lamotrigine
10838227|NCT00203242|BG000|Baseline|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
10838228|NCT00203242|FG000|Participant Flow|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
10838229|NCT00203242|OG000|Outcome|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
10838230|NCT00203242|EG000|Reported Event|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
10838231|NCT00203268|BG000|Baseline|Treatment Group|Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
10838232|NCT00203268|FG000|Participant Flow|Treatment Group|Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
10838233|NCT00203268|OG000|Outcome|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
10838234|NCT00203268|OG001|Outcome|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
10838235|NCT00203268|EG000|Reported Event|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
10838236|NCT00203268|EG001|Reported Event|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
10838237|NCT00203294|BG000|Baseline|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838238|NCT00203294|BG001|Baseline|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838239|NCT00203294|BG002|Baseline|Total|Total of all reporting groups
10838240|NCT00203294|FG000|Participant Flow|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838241|NCT00203294|FG001|Participant Flow|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838242|NCT00203294|OG000|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Saline|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
10838243|NCT00203294|OG001|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
10838244|NCT00203294|EG000|Reported Event|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838245|NCT00203294|EG001|Reported Event|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
10838246|NCT00203307|BG000|Baseline|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
10838247|NCT00203307|BG001|Baseline|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
10838248|NCT00203307|BG002|Baseline|Total|Total of all reporting groups
10838249|NCT00203307|FG000|Participant Flow|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
10838250|NCT00203307|FG001|Participant Flow|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
10838251|NCT00203307|OG000|Outcome|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
10838252|NCT00203307|OG001|Outcome|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
10838253|NCT00203307|EG000|Reported Event|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
10838254|NCT00203307|EG001|Reported Event|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
10838255|NCT00203411|BG000|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
10838256|NCT00203411|FG000|Participant Flow|Bevacizumab Plus Capecitabine|"Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.~Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period~Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks"
10838257|NCT00203411|OG000|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
10838258|NCT00203411|OG000|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
10838259|NCT00203411|EG000|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
10838260|NCT00203424|BG000|Baseline|Erlotinib + Bevacizumab|Participants that entered treatment period.
10838261|NCT00203424|FG000|Participant Flow|Erlotinib + Bevacizumab|27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
10838262|NCT00203424|OG000|Outcome|Bevacizumab+Erlotinib|
10838263|NCT00203424|EG000|Reported Event|Erlotinib + Bevacizumab|Participants that entered treatment period.
10838264|NCT00203476|BG000|Baseline|Niacin|Niacin added to max tolerated dose of statin
10838265|NCT00203476|BG001|Baseline|Colestipol|Colestipol added to max dose statin
10838266|NCT00203476|BG002|Baseline|Ezetimibe|Ezetimibe added to max tolerated dose statin
10838267|NCT00203476|BG003|Baseline|Total|Total of all reporting groups
10838268|NCT00203476|FG000|Participant Flow|Niacin|Niacin added to max tolerated dose of statin
10838269|NCT00203476|FG001|Participant Flow|Colestipol|Colestipol added to max dose statin
10838270|NCT00203476|FG002|Participant Flow|Ezetimibe|Ezetimibe added to max tolerated dose statin
10838271|NCT00203476|OG000|Outcome|Niacin|Niacin added to max tolerated dose of statin
10838272|NCT00203476|OG001|Outcome|Colestipol|Colestipol added to max dose statin
10838273|NCT00203476|OG002|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
10838274|NCT00203476|EG000|Reported Event|Niacin|Niacin added to max tolerated dose of statin
10838275|NCT00203476|EG001|Reported Event|Colestipol|Colestipol added to max dose statin
10838276|NCT00203476|EG002|Reported Event|Ezetimibe|Ezetimibe added to max tolerated dose statin
10838277|NCT00203502|BG000|Baseline|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
10838278|NCT00203502|FG000|Participant Flow|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
10838279|NCT00203502|OG000|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
10838280|NCT00203502|EG000|Reported Event|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
10838281|NCT00203892|BG000|Baseline|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838282|NCT00203892|BG001|Baseline|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838283|NCT00203892|BG002|Baseline|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838284|NCT00203892|BG003|Baseline|Total|Total of all reporting groups
10838285|NCT00203892|FG000|Participant Flow|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838286|NCT00203892|FG001|Participant Flow|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838287|NCT00203892|FG002|Participant Flow|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838288|NCT00203892|OG000|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838289|NCT00203892|OG001|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838290|NCT00203892|OG002|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838291|NCT00203892|EG000|Reported Event|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838292|NCT00203892|EG001|Reported Event|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838293|NCT00203892|EG002|Reported Event|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
10838294|NCT00203931|BG000|Baseline|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
10838295|NCT00203931|BG001|Baseline|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
10838296|NCT00203931|BG002|Baseline|Total|Total of all reporting groups
10838297|NCT00203931|FG000|Participant Flow|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
10838298|NCT00203931|FG001|Participant Flow|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
10838299|NCT00203931|OG000|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
10838300|NCT00203931|OG001|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
10838301|NCT00203931|OG000|Outcome|Early Rash|Presence of rash (grade 1 or higher) by day 21 of cetuximab therapy
10838302|NCT00203931|OG001|Outcome|No Early Rash|Absence of rash (grade 1 or higher) by day 21 of cetuximab therapy
10838303|NCT00203931|OG000|Outcome|Poor Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
10838304|NCT00203931|OG001|Outcome|Good Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
10838305|NCT00203931|EG000|Reported Event|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
10838306|NCT00203931|EG001|Reported Event|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
10838307|NCT00203996|BG000|Baseline|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
10838308|NCT00203996|BG001|Baseline|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
10838309|NCT00203996|BG002|Baseline|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
10838310|NCT00203996|BG003|Baseline|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838311|NCT00203996|BG004|Baseline|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838312|NCT00203996|BG005|Baseline|Aim 3: All Participants|Includes groups randomized to any experimental ordering in Aim 3
10838313|NCT00203996|BG006|Baseline|Total|Total of all reporting groups
10838314|NCT00203996|FG000|Participant Flow|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
10838315|NCT00203996|FG001|Participant Flow|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
10838316|NCT00203996|FG002|Participant Flow|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
10838317|NCT00203996|FG003|Participant Flow|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838318|NCT00203996|FG004|Participant Flow|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838319|NCT00203996|FG005|Participant Flow|Aim 3: REM Frag - SWS Supp - Baseline|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
10838320|NCT00203996|FG006|Participant Flow|Aim 3: REM Frag - Baseline - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
10838321|NCT00203996|FG007|Participant Flow|Aim 3: Baseline - REM Frag - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
10838322|NCT00203996|FG008|Participant Flow|Aim 3: SWS Supp - REM Frag - Baseline|"Each subject was assessed under three experimental conditions in the following order.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
10838323|NCT00203996|FG009|Participant Flow|Aim 3: Baseline - SWS Supp - REM Frag|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed."
10838324|NCT00203996|OG000|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
10838325|NCT00203996|OG001|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
10838326|NCT00203996|OG002|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
10838327|NCT00203996|OG000|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838328|NCT00203996|OG001|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838329|NCT00203996|OG000|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
10838330|NCT00203996|OG001|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
10838331|NCT00203996|EG000|Reported Event|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
10838332|NCT00203996|EG001|Reported Event|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
10838333|NCT00203996|EG002|Reported Event|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
10838334|NCT00203996|EG003|Reported Event|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838335|NCT00203996|EG004|Reported Event|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
10838336|NCT00203996|EG005|Reported Event|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
10838337|NCT00203996|EG006|Reported Event|Aim 3: SWS Suppression|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
10838338|NCT00204373|BG000|Baseline|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
10838339|NCT00204373|FG000|Participant Flow|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
10838340|NCT00204373|OG000|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
10838341|NCT00204373|EG000|Reported Event|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
10838342|NCT00204932|BG000|Baseline|Conjugated Linoleic Acid|3 grams per day for 7 months
10838343|NCT00204932|BG001|Baseline|Placebo|3 grams per day of sunflower oil for 7 months
10838344|NCT00204932|BG002|Baseline|Total|Total of all reporting groups
10838345|NCT00204932|FG000|Participant Flow|Conjugated Linoleic Acid|4 grams per day of 78% CLA for 6 months
10838346|NCT00204932|FG001|Participant Flow|Placebo|4 grams per day of sunflower oil for 6 months
10838347|NCT00204932|OG000|Outcome|Conjugated Linoleic Acid|3 grams per day for 7 months
10838348|NCT00204932|OG001|Outcome|Placebo|3 grams per day of sunflower oil for 7 months
10838349|NCT00204932|EG000|Reported Event|Conjugated Linoleic Acid|4 grams of 78% active CLA per day for 6 months
10838350|NCT00204932|EG001|Reported Event|Placebo|4 grams per day of sunflower oil for 6 months
10838351|NCT00205179|BG000|Baseline|Placebo|"100mg/day matching placebo~Placebo: 100mg/day matching placebo"
10838352|NCT00205179|BG001|Baseline|Novasoy|"100mg/day soy isoflavones~Novasoy: 100mg/day soy isoflavones"
10838353|NCT00205179|BG002|Baseline|Total|Total of all reporting groups
10838354|NCT00205179|FG000|Participant Flow|Novasoy|"100mg/day soy isoflavones~Novasoy: 100mg/day soy isoflavones"
10838355|NCT00205179|FG001|Participant Flow|Placebo|"100mg/day matching placebo~Placebo: 100mg/day matching placebo"
10838356|NCT00205179|OG000|Outcome|Placebo|"100mg/day matching placebo~Placebo: 100mg/day matching placebo"
10838357|NCT00205179|OG001|Outcome|Novasoy|"100mg/day soy isoflavones~Novasoy: 100mg/day soy isoflavones"
10838358|NCT00205179|OG001|Outcome|Novasoy Treated|"100mg/day soy isoflavones~Novasoy: 100mg/day soy isoflavones"
10838359|NCT00205179|EG000|Reported Event|Active|"100mg/day soy isoflavones~Novasoy: 100mg/day soy isoflavones"
10838360|NCT00205179|EG001|Reported Event|Placebo|"100mg/day matching placebo~Placebo: 100mg/day matching placebo"
10838361|NCT00205348|BG000|Baseline|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
10838362|NCT00205348|FG000|Participant Flow|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
10838363|NCT00205348|OG000|Outcome|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable."
10838364|NCT00205348|EG000|Reported Event|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
10838365|NCT00205374|BG000|Baseline|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838366|NCT00205374|BG001|Baseline|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838367|NCT00205374|BG002|Baseline|Total|Total of all reporting groups
10838368|NCT00205374|FG000|Participant Flow|Cidofovir|With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis. No more than 6 treatments were performed per patient within the 12-month time interval of the study.
10838369|NCT00205374|FG001|Participant Flow|Placebo|The placebo treatment was injection of saline solution that had a color and viscosity identical to those of the active drug. Up to 6 injections per participant were given during the study.
10838370|NCT00205374|OG000|Outcome|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838371|NCT00205374|OG001|Outcome|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838372|NCT00205374|EG000|Reported Event|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838373|NCT00205374|EG001|Reported Event|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
10838374|NCT00205504|BG000|Baseline|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
10838375|NCT00205504|BG001|Baseline|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
10838376|NCT00205504|BG002|Baseline|Total|Total of all reporting groups
10838377|NCT00205504|FG000|Participant Flow|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
10838378|NCT00205504|FG001|Participant Flow|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
10838379|NCT00205504|OG000|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
10838380|NCT00205504|OG001|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
10838381|NCT00205504|OG000|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
10838382|NCT00205504|OG001|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
10838383|NCT00205504|OG000|Outcome|Obese Women|Women with BMI >30 kg/m²
10838384|NCT00205504|OG001|Outcome|Lean Women|Women with BMI >25 kg/m²
10838385|NCT00205504|EG000|Reported Event|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
10838386|NCT00205504|EG001|Reported Event|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
10838387|NCT00205660|BG000|Baseline|Stay|Subjects in this group stayed on their current antipsychotic.
10838388|NCT00205660|BG001|Baseline|Switch|Subjects in this group switched to aripiprazole from their current antipsychotic.
10838389|NCT00205660|BG002|Baseline|Total|Total of all reporting groups
10838390|NCT00205660|FG000|Participant Flow|Stayers|Participants in this arm were randomized to stay on their current antipsychotic.
10838391|NCT00205660|FG001|Participant Flow|Switchers|Participants in this arm were randomized to switch to aripiprazole from their current antipsychotic.
10838392|NCT00205660|OG000|Outcome|Stayers|The subjects in this arm stayed on their current antipsychotic following entry into the study.
10838393|NCT00205660|OG001|Outcome|Switchers|The subjects in this arm switched to aripiprazole from their current antipsychotic following entry into the study.
10838394|NCT00205660|OG002|Outcome|Total|This arm consists of pooled treatment groups (i.e., those who stayed on their current antipsychotic and those who switched to aripiprazole).
10838395|NCT00205660|EG000|Reported Event|Stay|Includes subjects who stayed on their current antipsychotic throughout the study
10838396|NCT00205660|EG001|Reported Event|Switch|Includes subjects who switched to aripiprazole
10838397|NCT00205699|BG000|Baseline|Risperidone|12 weeks randomized, flexibly-dosed treatment with risperidone
10838398|NCT00205699|BG001|Baseline|Olanzapine|12 weeks randomized, flexibly-dosed treatment with olanzapine
10838399|NCT00205699|BG002|Baseline|Aripiprazole|12 weeks randomized, flexibly-dosed treatment with aripiprazole
10838400|NCT00205699|BG003|Baseline|Total|Total of all reporting groups
10838401|NCT00205699|FG000|Participant Flow|Risperidone|12 weeks of randomized treatment with flexibly dosed risperidone
10838402|NCT00205699|FG001|Participant Flow|Olanzapine|12 weeks of randomized treatment with flexibly dosed olanzapine
10838403|NCT00205699|FG002|Participant Flow|Aripiprazole|12 weeks of randomized treatment with flexibly dosed aripiprazole
10838404|NCT00205699|OG000|Outcome|Risperidone|12 weeks randomized, flexibly-dosed treatment with risperidone
10838405|NCT00205699|OG001|Outcome|Olanzapine|12 weeks randomized, flexibly-dosed treatment with olanzapine
10838406|NCT00205699|OG002|Outcome|Aripiprazole|12 weeks randomized, flexibly-dosed treatment with aripiprazole
10838407|NCT00205699|OG000|Outcome|Risperidone|12 weeks of randomized treatment with flexibly dosed risperidone
10838408|NCT00205699|OG001|Outcome|Olanzapine|12 weeks of randomized treatment with flexibly dosed olanzapine
10838409|NCT00205699|OG002|Outcome|Aripiprazole|12 weeks of randomized treatment with flexibly dosed aripiprazole
10838410|NCT00205699|EG000|Reported Event|Aripiprazole|Participants in this group were randomized to treatment with aripiprazole.
10838411|NCT00205699|EG001|Reported Event|Olanzapine|Participants in this group were randomized to treatment with olanzapine.
10838412|NCT00205699|EG002|Reported Event|Risperidone|Participants in this group were randomized to treatment with risperidone.
10838413|NCT00205712|BG000|Baseline|Ketamine Alone|ketamine without dexmedetomidine
10838414|NCT00205712|BG001|Baseline|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
10838415|NCT00205712|BG002|Baseline|Total|Total of all reporting groups
10838416|NCT00205712|FG000|Participant Flow|Ketamine Alone|Ketamine without dexmedetomidine
10838417|NCT00205712|FG001|Participant Flow|Ketamine Plus Dexmedetomidine|Ketamine infusion plus dexmedetomidine
10838418|NCT00205712|OG000|Outcome|Ketamine Alone|ketamine without dexmedetomidine
10838419|NCT00205712|OG001|Outcome|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
10838420|NCT00205712|OG000|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
10838421|NCT00205712|OG001|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
10838422|NCT00205712|EG000|Reported Event|Ketamine Alone|Ketamine without dexmedetomidine
10838423|NCT00205712|EG001|Reported Event|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
10838424|NCT00205777|BG000|Baseline|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
10838425|NCT00205777|BG001|Baseline|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838426|NCT00205777|BG002|Baseline|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838427|NCT00205777|BG003|Baseline|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838428|NCT00205777|BG004|Baseline|Total|Total of all reporting groups
10838429|NCT00205777|FG000|Participant Flow|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
10838430|NCT00205777|FG001|Participant Flow|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838431|NCT00205777|FG002|Participant Flow|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838432|NCT00205777|FG003|Participant Flow|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838433|NCT00205777|FG004|Participant Flow|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838434|NCT00205777|FG005|Participant Flow|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838435|NCT00205777|OG000|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
10838436|NCT00205777|OG001|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838437|NCT00205777|OG002|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838438|NCT00205777|OG003|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838439|NCT00205777|OG001|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838440|NCT00205777|OG002|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838441|NCT00205777|OG000|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838442|NCT00205777|OG001|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838443|NCT00205777|OG003|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838444|NCT00205777|EG000|Reported Event|Bazedoxifene 20 mg|Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II.
10838445|NCT00205777|EG001|Reported Event|Bazedoxifene 40/ 20 mg|Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838446|NCT00205777|EG002|Reported Event|Raloxifene 60 mg (Core Study)|Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
10838447|NCT00205777|EG003|Reported Event|Placebo|Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II.
10838448|NCT00205803|BG000|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838449|NCT00205803|BG001|Baseline|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838450|NCT00205803|BG002|Baseline|Total|Total of all reporting groups
10838451|NCT00205803|FG000|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838452|NCT00205803|FG001|Participant Flow|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838453|NCT00205803|OG000|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
10838454|NCT00205803|OG001|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
10838455|NCT00205803|OG002|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
10838456|NCT00205803|OG003|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
10838457|NCT00205803|OG004|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
10838458|NCT00205803|OG005|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
10838459|NCT00205803|OG006|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
10838460|NCT00205803|OG007|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
10838461|NCT00205803|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838462|NCT00205803|OG001|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838463|NCT00205803|OG000|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
10838464|NCT00205803|OG001|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
10838465|NCT00205803|OG002|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838466|NCT00205803|OG003|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838467|NCT00205803|OG000|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
10838468|NCT00205803|OG001|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
10838469|NCT00205803|EG000|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
10838470|NCT00205803|EG001|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
10838471|NCT00205803|EG002|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
10838472|NCT00205803|EG003|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
10838473|NCT00205803|EG004|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838474|NCT00205803|EG005|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
10838475|NCT00205855|BG000|Baseline|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
10838476|NCT00205855|FG000|Participant Flow|Spinal Cord Stimulation (SCS) Group|"Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered trial durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System."
10838477|NCT00205855|OG000|Outcome|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
10838478|NCT00205855|EG000|Reported Event|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
10838479|NCT00205881|BG000|Baseline|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
10838480|NCT00205881|FG000|Participant Flow|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
10838481|NCT00205881|OG000|Outcome|Baseline|Testing with hearing aids in best-aided condition.
10838482|NCT00205881|OG001|Outcome|8 Months Post-device Activation|Testing conducted with bilateral implants.
10838483|NCT00205881|EG000|Reported Event|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
10838484|NCT00206076|BG000|Baseline|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
10838485|NCT00206076|BG001|Baseline|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
10838486|NCT00206076|BG002|Baseline|Total|Total of all reporting groups
10838487|NCT00206076|FG000|Participant Flow|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
10838488|NCT00206076|FG001|Participant Flow|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
10838489|NCT00206076|OG000|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
10838490|NCT00206076|OG001|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
10838491|NCT00206076|OG000|Outcome|CNI Discontinued|complete withdrawal of calcineurin inhibitors (CNI)
10838492|NCT00206076|OG001|Outcome|CNI Reduction|calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment
10838493|NCT00206076|EG000|Reported Event|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
10838494|NCT00206076|EG001|Reported Event|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
10838495|NCT00206102|BG000|Baseline|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
10838496|NCT00206102|BG001|Baseline|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
10838497|NCT00206102|BG002|Baseline|Total|Total of all reporting groups
10838498|NCT00206102|FG000|Participant Flow|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
10838499|NCT00206102|FG001|Participant Flow|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
10838500|NCT00206102|OG000|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
10838501|NCT00206102|OG001|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
10838502|NCT00206102|EG000|Reported Event|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
10838503|NCT00206102|EG001|Reported Event|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
10838504|NCT00206323|BG000|Baseline|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
10838505|NCT00206323|BG001|Baseline|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
10838506|NCT00206323|BG002|Baseline|Total|Total of all reporting groups
10838507|NCT00206323|FG000|Participant Flow|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
10838508|NCT00206323|FG001|Participant Flow|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
10838509|NCT00206323|OG000|Outcome|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
10838510|NCT00206323|OG001|Outcome|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
10838511|NCT00206323|EG000|Reported Event|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
10838512|NCT00206323|EG001|Reported Event|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
10838513|NCT00206336|BG000|Baseline|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
10838514|NCT00206336|FG000|Participant Flow|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
10838515|NCT00206336|OG000|Outcome|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
10838516|NCT00206336|EG000|Reported Event|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
10838517|NCT00206427|BG000|Baseline|GW572016 1500mg|patients received GW572016 1500mg daily
10838518|NCT00206427|FG000|Participant Flow|GW572016 1500mg|The study had only 1 treatment group and all patient had GW572016 1500mg daily.
10838519|NCT00206427|OG000|Outcome|GW572016 1500mg|patients received GW572016 1500mg daily
10838520|NCT00206427|EG000|Reported Event|GW572016 1500mg|patients received GW572016 1500mg daily
10838521|NCT00206440|BG000|Baseline|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
10838522|NCT00206440|BG001|Baseline|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
10838523|NCT00206440|BG002|Baseline|Total|Total of all reporting groups
10838524|NCT00206440|FG000|Participant Flow|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
10838525|NCT00206440|FG001|Participant Flow|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
10838526|NCT00206440|OG000|Outcome|Esomeprazole|The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
10838527|NCT00206440|OG001|Outcome|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
10838528|NCT00206440|EG000|Reported Event|Esomeprazole|The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
10838529|NCT00206440|EG001|Reported Event|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
10838530|NCT00206518|BG000|Baseline|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
10838531|NCT00206518|BG001|Baseline|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
10838532|NCT00206518|BG002|Baseline|Total|Total of all reporting groups
10843317|NCT00253643|FG003|Participant Flow|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
10843318|NCT00253643|OG000|Outcome|Arm I|Fish oil, Green Tea catechin extract
10843319|NCT00253643|OG001|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
10838533|NCT00206518|FG000|Participant Flow|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
10838534|NCT00206518|FG001|Participant Flow|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
10838535|NCT00206518|OG000|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
10838536|NCT00206518|OG001|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
10838537|NCT00206518|EG000|Reported Event|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
10838538|NCT00206518|EG001|Reported Event|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
10838539|NCT00206726|BG000|Baseline|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
10838540|NCT00206726|FG000|Participant Flow|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
10838541|NCT00206726|OG000|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
10838542|NCT00206726|EG000|Reported Event|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
10838543|NCT00207090|BG000|Baseline|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
10838544|NCT00207090|FG000|Participant Flow|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
10838545|NCT00207090|OG000|Outcome|Ixabepilone|"On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles - see the ixabepilone + rifampin treatment arm)."
10843320|NCT00253643|OG002|Outcome|Arm III|Fish oil, Green Tea placebo
10843321|NCT00253643|OG003|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
10843322|NCT00253643|EG000|Reported Event|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
10838546|NCT00207090|OG001|Outcome|Ixabepilone + Rifampin|"Having already received ixabepilone on Day 1 of Cycle 1 (see the ixabepilone treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles."
10838547|NCT00207090|OG000|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
10838548|NCT00207090|OG000|Outcome|All Participants|All participants who were enrolled into the study, 24 hours before ixabepilone administration on Day -1. Each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2 on Day 1 of Cycle 1. Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23 through 28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food during Cycle 2.
10838549|NCT00207090|OG000|Outcome|Ixabepilone + Rifampin|Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
10838550|NCT00207090|OG000|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
10838551|NCT00207090|EG000|Reported Event|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
10838552|NCT00207142|BG000|Baseline|Randomized Subjects: Switch Regimen|ATV 400 mg QD + 2 NRTIs
10838553|NCT00207142|BG001|Baseline|Randomized Subjects: Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
10838554|NCT00207142|BG002|Baseline|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
10838555|NCT00207142|BG003|Baseline|Total|Total of all reporting groups
10838556|NCT00207142|FG000|Participant Flow|Induction Treatment|Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
10838557|NCT00207142|FG001|Participant Flow|Maintenance Treatment: Switch Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
10838558|NCT00207142|FG002|Participant Flow|Maintenance Treatment: Continuation Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
10838559|NCT00207142|FG003|Participant Flow|Rescue Treatment|Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
10838560|NCT00207142|OG000|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
10838561|NCT00207142|OG001|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
10838562|NCT00207142|OG000|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
10838563|NCT00207142|OG001|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
10838564|NCT00207142|OG002|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
10838565|NCT00207142|OG000|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
10838566|NCT00207142|OG000|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
10838567|NCT00207142|OG001|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
10838568|NCT00207142|OG000|Outcome|Switch Regimen|ATV 400mg QD + 2NRTIs
10838569|NCT00207142|OG001|Outcome|Continuation Regimen|ATV 300mg + RTV 100mg QD + 2NRTIs
10838570|NCT00207142|EG000|Reported Event|Switch Regimen|ATV 400 mg QD + 2 NRTIs
10838571|NCT00207142|EG001|Reported Event|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
10838572|NCT00207142|EG002|Reported Event|Non-Randomized Participants|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
10838573|NCT00207714|BG000|Baseline|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
10838574|NCT00207714|BG001|Baseline|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
10838575|NCT00207714|BG002|Baseline|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
10838576|NCT00207714|BG003|Baseline|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
10838577|NCT00207714|BG004|Baseline|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
10838578|NCT00207714|BG005|Baseline|Total|Total of all reporting groups
10838579|NCT00207714|FG000|Participant Flow|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
10838580|NCT00207714|FG001|Participant Flow|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
10838581|NCT00207714|FG002|Participant Flow|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
10838582|NCT00207714|FG003|Participant Flow|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
10838583|NCT00207714|FG004|Participant Flow|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
10838584|NCT00207714|OG000|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
10838585|NCT00207714|OG001|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838586|NCT00207714|OG002|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838587|NCT00207714|OG003|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
10843323|NCT00253643|EG001|Reported Event|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
10838588|NCT00207714|OG004|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838589|NCT00207714|OG005|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
10838590|NCT00207714|OG000|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
10838591|NCT00207714|OG001|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838592|NCT00207714|OG002|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838593|NCT00207714|OG003|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
10838594|NCT00207714|OG004|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
10838595|NCT00207714|OG005|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
10838596|NCT00207714|EG000|Reported Event|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
10838597|NCT00207714|EG001|Reported Event|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
10838598|NCT00207714|EG002|Reported Event|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
10838599|NCT00207714|EG003|Reported Event|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
10838600|NCT00207714|EG004|Reported Event|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
10838601|NCT00207727|BG000|Baseline|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
10838602|NCT00207727|BG001|Baseline|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838603|NCT00207727|BG002|Baseline|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
10838604|NCT00207727|BG003|Baseline|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838605|NCT00207727|BG004|Baseline|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838606|NCT00207727|BG005|Baseline|Total|Total of all reporting groups
10838607|NCT00207727|FG000|Participant Flow|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
10838608|NCT00207727|FG001|Participant Flow|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838609|NCT00207727|FG002|Participant Flow|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
10838610|NCT00207727|FG003|Participant Flow|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838611|NCT00207727|FG004|Participant Flow|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838612|NCT00207727|OG000|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
10838613|NCT00207727|OG001|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838614|NCT00207727|OG002|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
10838615|NCT00207727|OG003|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838616|NCT00207727|OG004|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838617|NCT00207727|EG000|Reported Event|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
10838618|NCT00207727|EG001|Reported Event|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838619|NCT00207727|EG002|Reported Event|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
10838620|NCT00207727|EG003|Reported Event|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838621|NCT00207727|EG004|Reported Event|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
10838622|NCT00207740|BG000|Baseline|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
10838623|NCT00207740|BG001|Baseline|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
10838624|NCT00207740|BG002|Baseline|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
10838625|NCT00207740|BG003|Baseline|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
10838626|NCT00207740|BG004|Baseline|Total|Total of all reporting groups
10838627|NCT00207740|FG000|Participant Flow|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
10838628|NCT00207740|FG001|Participant Flow|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
10838629|NCT00207740|FG002|Participant Flow|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
10838630|NCT00207740|FG003|Participant Flow|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
10838631|NCT00207740|OG000|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
10838632|NCT00207740|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
10838633|NCT00207740|OG002|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
10838634|NCT00207740|OG003|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
10838635|NCT00207740|OG004|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
10838636|NCT00207740|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
10838637|NCT00207740|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
10838638|NCT00207740|OG000|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
10838639|NCT00207740|EG000|Reported Event|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
10838640|NCT00207740|EG001|Reported Event|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
10838641|NCT00207740|EG002|Reported Event|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
10838642|NCT00207740|EG003|Reported Event|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
10838643|NCT00207883|BG000|Baseline|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
10838644|NCT00207883|BG001|Baseline|Group 2 - US|ultra sound assisted CVC placement
10838645|NCT00207883|BG002|Baseline|Total|Total of all reporting groups
10838646|NCT00207883|FG000|Participant Flow|Group 1 - Traditional Anatomic Landmark- LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
10838647|NCT00207883|FG001|Participant Flow|Group 2 - Ultra Sound US|ultra sound assisted CVC placement
10838648|NCT00207883|OG000|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
10838649|NCT00207883|OG001|Outcome|Group 2 - US|ultra sound assisted CVC placement
10838650|NCT00207883|EG000|Reported Event|Group 1 - LM|"traditional anatomic landmark central line placement utilizing palpation and the Seldinger technique.~18/93 (19.4%) had arterial puncture. None was considered serious."
10838651|NCT00207883|EG001|Reported Event|Group 2 - US|ultra sound assisted central line placement 10/118 (8.5%) had arterial puncture. None was considered serious.
10838652|NCT00208026|BG000|Baseline|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
10838653|NCT00208026|FG000|Participant Flow|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
10838654|NCT00208026|OG000|Outcome|Patient 1|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
10838655|NCT00208026|OG001|Outcome|Patient 2|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
10838656|NCT00208026|OG002|Outcome|Patient 3|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
10838657|NCT00208026|EG000|Reported Event|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
10838658|NCT00208091|BG000|Baseline|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
10838659|NCT00208091|FG000|Participant Flow|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
10838660|NCT00208091|OG000|Outcome|Note Errors (Related to Errors in Duration), Baseline|Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
10838661|NCT00208091|OG001|Outcome|Note Errors (Related to Errors in Duration), Post-injection|Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
10838662|NCT00208091|OG000|Outcome|Note Errors, Baseline|Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note loudness.
10838663|NCT00208091|OG001|Outcome|Note Errors, Post-injection|Note errors (related to errors in loudness) 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
10838664|NCT00208091|OG000|Outcome|Post-injection Subjective Change|Subjective assessment 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
10838665|NCT00208091|EG000|Reported Event|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
10838666|NCT00208325|BG000|Baseline|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838667|NCT00208325|BG001|Baseline|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838668|NCT00208325|BG002|Baseline|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838669|NCT00208325|BG003|Baseline|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838670|NCT00208325|BG004|Baseline|Total|Total of all reporting groups
10838671|NCT00208325|FG000|Participant Flow|PFC Fixed Bearing PCL Sacrificed|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
10838672|NCT00208325|FG001|Participant Flow|PFC Mobile Bearing PCL Sacrificed|"Mobile bearing~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838673|NCT00208325|FG002|Participant Flow|PFC Fixed Bearing PCL Retained|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
10838674|NCT00208325|FG003|Participant Flow|PFC Mobile Bearing PCL Retained|"Mobile bearing~P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement"
10838675|NCT00208325|OG000|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838676|NCT00208325|OG001|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838677|NCT00208325|OG000|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838678|NCT00208325|OG001|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838679|NCT00208325|EG000|Reported Event|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838680|NCT00208325|EG001|Reported Event|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838681|NCT00208325|EG002|Reported Event|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
10838682|NCT00208325|EG003|Reported Event|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
10838683|NCT00208494|BG000|Baseline|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
10838684|NCT00208494|BG001|Baseline|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
10838685|NCT00208494|BG002|Baseline|Total|Total of all reporting groups
10838686|NCT00208494|FG000|Participant Flow|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
10838687|NCT00208494|FG001|Participant Flow|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
10838688|NCT00208494|OG000|Outcome|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
10838689|NCT00208494|OG001|Outcome|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
10838690|NCT00208494|EG000|Reported Event|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
10838691|NCT00208494|EG001|Reported Event|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
10838692|NCT00208507|BG000|Baseline|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838693|NCT00208507|BG001|Baseline|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838694|NCT00208507|BG002|Baseline|Total|Total of all reporting groups
10838695|NCT00208507|FG000|Participant Flow|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838696|NCT00208507|FG001|Participant Flow|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838697|NCT00208507|OG000|Outcome|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838698|NCT00208507|OG001|Outcome|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838699|NCT00208507|EG000|Reported Event|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838700|NCT00208507|EG001|Reported Event|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
10838701|NCT00208767|BG000|Baseline|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
10838702|NCT00208767|BG001|Baseline|Placebo|Patients received a placebo instead of Valsartan
10838703|NCT00208767|BG002|Baseline|Total|Total of all reporting groups
10838704|NCT00208767|FG000|Participant Flow|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
10838705|NCT00208767|FG001|Participant Flow|Placebo|Patients received a placebo instead of Valsartan
10838706|NCT00208767|OG000|Outcome|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
10838707|NCT00208767|OG001|Outcome|Placebo|Patients received a placebo instead of Valsartan
10838708|NCT00208767|EG000|Reported Event|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
10838709|NCT00208767|EG001|Reported Event|Placebo|Patients received a placebo instead of Valsartan
10838710|NCT00208949|BG000|Baseline|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
10838711|NCT00208949|BG001|Baseline|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
10838712|NCT00208949|BG002|Baseline|Total|Total of all reporting groups
10838713|NCT00208949|FG000|Participant Flow|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
10838714|NCT00208949|FG001|Participant Flow|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
10838715|NCT00208949|OG000|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
10838716|NCT00208949|OG001|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
10838717|NCT00208949|EG000|Reported Event|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
10838718|NCT00208949|EG001|Reported Event|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
10838719|NCT00208975|BG000|Baseline|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
10838720|NCT00208975|FG000|Participant Flow|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
10838721|NCT00208975|OG000|Outcome|Chronic Lymphocytic Leukemia|"Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
10838722|NCT00208975|OG001|Outcome|Non Hodgkin Lymphoma|"Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes - a type of white blood cell.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
10838723|NCT00208975|EG000|Reported Event|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
10838724|NCT00209092|BG000|Baseline|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
10838725|NCT00209092|BG001|Baseline|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
10838726|NCT00209092|BG002|Baseline|Total|Total of all reporting groups
10838727|NCT00209092|FG000|Participant Flow|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
10838728|NCT00209092|FG001|Participant Flow|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
10838729|NCT00209092|OG000|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
10838730|NCT00209092|OG001|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
10838731|NCT00209092|EG000|Reported Event|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
10838732|NCT00209092|EG001|Reported Event|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
10838733|NCT00209170|BG000|Baseline|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
10838734|NCT00209170|BG001|Baseline|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
10838735|NCT00209170|BG002|Baseline|Total|Total of all reporting groups
10838736|NCT00209170|FG000|Participant Flow|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
10838737|NCT00209170|FG001|Participant Flow|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
10838738|NCT00209170|OG000|Outcome|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
10838739|NCT00209170|OG001|Outcome|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
10838740|NCT00209170|EG000|Reported Event|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
10838741|NCT00209170|EG001|Reported Event|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
10838742|NCT00209274|BG000|Baseline|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
10838743|NCT00209274|BG001|Baseline|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
10838744|NCT00209274|BG002|Baseline|Total|Total of all reporting groups
10838745|NCT00209274|FG000|Participant Flow|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
10838746|NCT00209274|FG001|Participant Flow|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
10838747|NCT00209274|OG000|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
10838748|NCT00209274|OG001|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
10838749|NCT00209274|EG000|Reported Event|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
10838750|NCT00209274|EG001|Reported Event|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
10838751|NCT00209339|BG000|Baseline|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
10838752|NCT00209339|FG000|Participant Flow|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
10838753|NCT00209339|OG000|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
10838754|NCT00209339|EG000|Reported Event|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
10838755|NCT00209417|BG000|Baseline|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
10838756|NCT00209417|BG001|Baseline|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
10838757|NCT00209417|BG002|Baseline|Total|Total of all reporting groups
10838758|NCT00209417|FG000|Participant Flow|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
10838759|NCT00209417|FG001|Participant Flow|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
10838760|NCT00209417|OG000|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
10838761|NCT00209417|OG001|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
10838762|NCT00209417|EG000|Reported Event|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
10838763|NCT00209417|EG001|Reported Event|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
10838764|NCT00209560|BG000|Baseline|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
10838765|NCT00209560|BG001|Baseline|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
10838766|NCT00209560|BG002|Baseline|Total|Total of all reporting groups
10838767|NCT00209560|FG000|Participant Flow|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
10838768|NCT00209560|FG001|Participant Flow|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
10838769|NCT00209560|OG000|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
10838770|NCT00209560|OG001|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
10838771|NCT00209560|EG000|Reported Event|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
10838772|NCT00209560|EG001|Reported Event|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
10838773|NCT00210106|BG000|Baseline|Intraoperative Radiofrequency Ablation (IRFA)|"IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.~Ablathermy"
10838774|NCT00210106|FG000|Participant Flow|Intraoperative Radiofrequency Ablation (IRFA)|"IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.~Ablathermy"
10838775|NCT00210106|OG000|Outcome|Intraoperative Radiofrequency Ablation (IRFA)|"IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.~Ablathermy"
10838776|NCT00210106|OG000|Outcome|Intraoperative Radiofrequency Ablation (IRFA)|IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.
10838777|NCT00210106|EG000|Reported Event|Intraoperative Radiofrequency Ablation (IRFA)|"IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.~Ablathermy"
10838778|NCT00210119|BG000|Baseline|Imatinib Mesylate|"Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.~Glivec"
10838779|NCT00210119|FG000|Participant Flow|Imatinib Mesylate|"Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.~Glivec"
10838780|NCT00210119|OG000|Outcome|Imatinib Mesylate|"Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.~Glivec"
10838781|NCT00210119|EG000|Reported Event|Imatinib Mesylate|"Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.~Glivec"
10838782|NCT00210184|BG000|Baseline|Irinotecan Associated to Fluorouracil and Leucovorin|"On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.~Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.~Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months~Translated with www.DeepL.com/Translator (free version)~Irinotecan associated to fluorouracil and leucovorin"
10838783|NCT00210184|FG000|Participant Flow|Irinotecan Associated to Fluorouracil and Leucovorin|"On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.~Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months."
10838784|NCT00210184|OG000|Outcome|Irinotecan Associated to Fluorouracil and Leucovorin|"On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.~Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.~Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months~Translated with www.DeepL.com/Translator (free version)~Irinotecan associated to fluorouracil and leucovorin"
10838785|NCT00210184|EG000|Reported Event|Irinotecan Associated to Fluorouracil and Leucovorin|"On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.~Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.~Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months~Translated with www.DeepL.com/Translator (free version)~Irinotecan associated to fluorouracil and leucovorin"
10838786|NCT00210353|BG000|Baseline|ARM A - Chlorambucil|Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
10838787|NCT00210353|BG001|Baseline|ARM B - Rituximab + Chlorambucil|Rituximab 375 mg/m2 iv, d1, d8, d15, d22 Chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
10838788|NCT00210353|BG002|Baseline|ARM C (Since April 2006) - Rituximab|Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
10838789|NCT00210353|BG003|Baseline|Total|Total of all reporting groups
10838790|NCT00210353|FG000|Participant Flow|ARM A - Chlorambucil|Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
10838791|NCT00210353|FG001|Participant Flow|ARM B - Rituximab + Chlorambucil|rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
10838792|NCT00210353|FG002|Participant Flow|ARM C (Since April 2006) - Rituximab|Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
10838793|NCT00210353|OG000|Outcome|ARM A - Chlorambucil|Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
10838794|NCT00210353|OG001|Outcome|ARM B - Rituximab + Chlorambucil|Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
10838795|NCT00210353|OG002|Outcome|ARM C (Since April 2006) - Rituximab|Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
10838796|NCT00210353|OG001|Outcome|ARM B - Rituximab + Chlorambucil|Rituximab 375 mg/m2 iv, d1, d8, d15, d22 Chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
10838797|NCT00210353|OG002|Outcome|ARM C (Since April 2006) - Ritiximab|rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
10838798|NCT00210353|OG000|Outcome|ARM A|"chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)~chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)"
10838799|NCT00210353|OG001|Outcome|ARM B|"rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle~rituximab+chlorambucil: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle"
10838800|NCT00210353|OG002|Outcome|ARM C (Since April 2006)|"rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140~rituximab: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140"
10843324|NCT00253643|EG002|Reported Event|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
10838801|NCT00210353|EG000|Reported Event|ARM A|"chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)~chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)"
10838802|NCT00210353|EG001|Reported Event|ARM B|"rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle~rituximab+chlorambucil: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle"
10838803|NCT00210353|EG002|Reported Event|ARM C (Since April 2006)|"rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140~rituximab: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140"
10838804|NCT00210470|BG000|Baseline|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
10838805|NCT00210470|FG000|Participant Flow|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
10838806|NCT00210470|OG000|Outcome|IRX-2 Regimen|A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation
10838807|NCT00210470|OG000|Outcome|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
10838808|NCT00210470|OG000|Outcome|High Lymphocyte Infiltration (LI)|Participants with high lymphocyte infiltration after treatment with the IRX-2 regimen
10838809|NCT00210470|OG001|Outcome|Low Lymphocyte Infiltration|Participants with low lymphocyte infiltration after treatment with the IRX-2 regimen
10838810|NCT00210470|EG000|Reported Event|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
10838811|NCT00210626|BG000|Baseline|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
10838812|NCT00210626|BG001|Baseline|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
10838813|NCT00210626|BG002|Baseline|Total|Total of all reporting groups
10838814|NCT00210626|FG000|Participant Flow|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
10838815|NCT00210626|FG001|Participant Flow|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
10838816|NCT00210626|OG000|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
10838817|NCT00210626|OG001|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
10838818|NCT00210626|EG000|Reported Event|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
10838819|NCT00210626|EG001|Reported Event|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
10838820|NCT00210639|BG000|Baseline|Levofloxacin|Participants who received levofloxacin in the previous studies.
10838821|NCT00210639|BG001|Baseline|Comparator|Participants who received comparator in the previous studies.
10838822|NCT00210639|BG002|Baseline|Total|Total of all reporting groups
10838823|NCT00210639|FG000|Participant Flow|Levofloxacin|Participants who received levofloxacin in the previous studies.
10838824|NCT00210639|FG001|Participant Flow|Comparator|Participants who received comparator in the previous studies.
10838825|NCT00210639|OG000|Outcome|Levofloxacin|Participants who received levofloxacin in the previous studies.
10838826|NCT00210639|OG001|Outcome|Comparator|Participants who received comparator in the previous studies.
10838827|NCT00210639|EG000|Reported Event|Levofloxacin|Participants who received levofloxacin in the previous studies.
10838828|NCT00210639|EG001|Reported Event|Comparator|Participants who received comparator in the previous studies.
10838829|NCT00211081|BG000|Baseline|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
10838830|NCT00211081|FG000|Participant Flow|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
10838831|NCT00211081|OG000|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
10838832|NCT00211081|EG000|Reported Event|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
10838833|NCT00211172|BG000|Baseline|Usual Care|Usual care patients were not contacted by the study.
10838834|NCT00211172|BG001|Baseline|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
10838835|NCT00211172|BG002|Baseline|Total|Total of all reporting groups
10838836|NCT00211172|FG000|Participant Flow|Usual Care|Usual care patients were not contacted by the study.
10838837|NCT00211172|FG001|Participant Flow|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
10838838|NCT00211172|OG000|Outcome|Usual Care|Usual care patients were not contacted by the study.
10838839|NCT00211172|OG001|Outcome|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
10838840|NCT00211172|EG000|Reported Event|Usual Care|Usual care patients were not contacted by the study.
10838841|NCT00211172|EG001|Reported Event|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
10838842|NCT00211185|BG000|Baseline|Denileukin Diftitox in Combination With CHOP|Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
10838843|NCT00211185|FG000|Participant Flow|Denileukin Diftitox in Combination With CHOP|Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
10838844|NCT00211185|OG000|Outcome|Denileukin Diftitox in Combination With CHOP|Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
10838845|NCT00211185|EG000|Reported Event|Denileukin Diftitox in Combination With CHOP|Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
10838846|NCT00211237|BG000|Baseline|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
10838847|NCT00211237|BG001|Baseline|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838848|NCT00211237|BG002|Baseline|Total|Total of all reporting groups
10838849|NCT00211237|FG000|Participant Flow|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
10838850|NCT00211237|FG001|Participant Flow|Non-surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838851|NCT00211237|FG002|Participant Flow|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
10838852|NCT00211237|OG000|Outcome|Balloon Kyphoplasty|The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
10838853|NCT00211237|OG001|Outcome|Non Surgical Management|The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838854|NCT00211237|OG000|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
10838855|NCT00211237|OG001|Outcome|Non-Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838856|NCT00211237|OG002|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
10838857|NCT00211237|OG001|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838858|NCT00211237|OG001|Outcome|Non Surgical Management|The subjects in this group undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838859|NCT00211237|OG000|Outcome|Balloon Kyphoplasty|The subjects were randomized to the Balloon Kyphoplasty.
10838860|NCT00211237|OG001|Outcome|Non Surgical Management|The subjects were randomized to NSM.
10838861|NCT00211237|OG000|Outcome|Balloon Kyphoplasty|The subjects were randomized to Balloon Kyphoplasty.
10838862|NCT00211237|OG001|Outcome|Non Surgical Management|The subjects were randomized to NSM without crossing over.
10838863|NCT00211237|OG002|Outcome|Crossover (AEs Collected Before BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
10838864|NCT00211237|OG003|Outcome|Crossover-(AEs Collected After BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
10838865|NCT00211237|EG000|Reported Event|Balloon Kyphoplasty|The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.
10838866|NCT00211237|EG001|Reported Event|Non Surgical Management|The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
10838867|NCT00211510|BG000|Baseline|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838868|NCT00211510|BG001|Baseline|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
10838869|NCT00211510|BG002|Baseline|Total|Total of all reporting groups
10838870|NCT00211510|FG000|Participant Flow|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838871|NCT00211510|FG001|Participant Flow|Paradigm 715 Insulin Pump|subjects with use the Paradigm 715 insulin pump for insulin infusion
10838872|NCT00211510|OG000|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838873|NCT00211510|OG001|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
10838874|NCT00211510|OG001|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 pump for insulin infusion
10838875|NCT00211510|OG000|Outcome|Paradigm 722 Sensor Augmented Pump|subjects with use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838876|NCT00211510|OG000|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 711 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838877|NCT00211510|EG000|Reported Event|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
10838878|NCT00211510|EG001|Reported Event|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
10838879|NCT00211536|BG000|Baseline|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10838880|NCT00211536|BG001|Baseline|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10838881|NCT00211536|BG002|Baseline|Total|Total of all reporting groups
10838882|NCT00211536|FG000|Participant Flow|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10838883|NCT00211536|FG001|Participant Flow|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10843325|NCT00253643|EG003|Reported Event|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
10848569|NCT00290472|OG002|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
10838884|NCT00211536|OG000|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10838885|NCT00211536|OG001|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
10838886|NCT00211536|EG000|Reported Event|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the As Treated group.~All randomized subjects were assessed for safety risk."
10838887|NCT00211536|EG001|Reported Event|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group. All randomized subjects were assessed for safety risk."
10838888|NCT00211692|BG000|Baseline|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
10838889|NCT00211692|BG001|Baseline|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
10838890|NCT00211692|BG002|Baseline|Total|Total of all reporting groups
10838891|NCT00211692|FG000|Participant Flow|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
10838892|NCT00211692|FG001|Participant Flow|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
10838893|NCT00211692|OG000|Outcome|A (52 Weeks Treatment)|
10838894|NCT00211692|OG001|Outcome|B (Duration Based on Viral Response)|
10838895|NCT00211692|OG000|Outcome|Overall|
10838896|NCT00211692|EG000|Reported Event|Overall|
10838897|NCT00211757|BG000|Baseline|Placebo|"Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.~Placebo: Placebo comparator."
10838898|NCT00211757|BG001|Baseline|Divalporex Sodium|"Subjects will receive the study drug, divalproex sodium.~Divalproex sodium: Study drug."
10838899|NCT00211757|BG002|Baseline|Total|Total of all reporting groups
10838900|NCT00211757|FG000|Participant Flow|Placebo|"Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.~Placebo: Placebo comparator."
10838901|NCT00211757|FG001|Participant Flow|Divalproex Sodium|"Subjects will receive the study drug, divalproex sodium.~Divalproex sodium: Study drug."
10838902|NCT00211757|OG000|Outcome|Placebo|"Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.~Placebo: Placebo comparator."
10838903|NCT00211757|OG001|Outcome|Divalproex Sodium|"Subjects will receive the study drug, divalproex sodium.~Divalproex sodium: Study drug."
10838904|NCT00211757|OG000|Outcome|Placebo|"Subjects in this arm will receive a placebo comparative to the study drug divalporex sodium.~Placebo: Placebo comparator."
10838905|NCT00211757|OG001|Outcome|Divalproex Sodium|"Subjects will receive the study drug, divalproex sodium.~divalproex sodium: Study drug."
10838906|NCT00211757|EG000|Reported Event|Placebo|"Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.~Placebo: Placebo comparator."
10838907|NCT00211757|EG001|Reported Event|Divalproex Sodium|"Subjects will receive the study drug, divalproex sodium.~Divalproex sodium: Study drug."
10838908|NCT00211809|BG000|Baseline|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
10838909|NCT00211809|FG000|Participant Flow|Body Dysmorphic Disorder|"Participants with body dysmorphic disorder~Standard Psychiatric Evaluation~Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks."
10838910|NCT00211809|OG000|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
10838911|NCT00211809|OG001|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
10838912|NCT00211809|OG000|Outcome|Body Dysmorphic Disorder|Participants with body dysmorphic disorder after Venlafaxine treatment up to 16 weeks
10838913|NCT00211809|EG000|Reported Event|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
10838914|NCT00211887|BG000|Baseline|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
10838915|NCT00211887|BG001|Baseline|IFB-1a|Interferon beta-1a
10838916|NCT00211887|BG002|Baseline|Glatiramer|glatiramer acetate
10838917|NCT00211887|BG003|Baseline|Total|Total of all reporting groups
10838918|NCT00211887|FG000|Participant Flow|IFN + GA|Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
10848570|NCT00290472|EG000|Reported Event|Temsirolimus|All patients
10838919|NCT00211887|FG001|Participant Flow|Interferon Beta 1a|Interferon beta-1a 30µg intramuscularly weekly
10838920|NCT00211887|FG002|Participant Flow|Glatiramer Acetate|glatiramer acetate 20mg daily
10838921|NCT00211887|OG000|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
10838922|NCT00211887|OG001|Outcome|IFB-1a|Interferon beta-1a
10838923|NCT00211887|OG002|Outcome|Glatiramer|glatiramer acetate
10838924|NCT00211887|EG000|Reported Event|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
10838925|NCT00211887|EG001|Reported Event|IFB-1a|Interferon beta-1a
10838926|NCT00211887|EG002|Reported Event|Glatiramer|glatiramer acetate
10838927|NCT00212134|BG000|Baseline|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
10838928|NCT00212134|BG001|Baseline|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
10838929|NCT00212134|BG002|Baseline|Total|Total of all reporting groups
10838930|NCT00212134|FG000|Participant Flow|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
10838931|NCT00212134|FG001|Participant Flow|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
10838932|NCT00212134|OG000|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly."
10838933|NCT00212134|OG001|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery."
10838934|NCT00212134|OG000|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
10838935|NCT00212134|OG001|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
10838936|NCT00212134|OG000|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.~hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens"
10838937|NCT00212134|OG001|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.~primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens"
10838938|NCT00212134|EG000|Reported Event|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
10838939|NCT00212134|EG001|Reported Event|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
10838940|NCT00212264|BG000|Baseline|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
10838941|NCT00212264|BG001|Baseline|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
10838942|NCT00212264|BG002|Baseline|Placebo Comparator|No treatment control
10838943|NCT00212264|BG003|Baseline|Total|Total of all reporting groups
10838944|NCT00212264|FG000|Participant Flow|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
10838945|NCT00212264|FG001|Participant Flow|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
10838946|NCT00212264|FG002|Participant Flow|Placebo Comparator|No treatment control
10838947|NCT00212264|OG000|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
10838948|NCT00212264|OG001|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
10838949|NCT00212264|OG002|Outcome|Placebo Comparator|No treatment control
10838950|NCT00212264|EG000|Reported Event|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
10838951|NCT00212264|EG001|Reported Event|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
10838952|NCT00212264|EG002|Reported Event|Placebo Comparator|No treatment control
10838953|NCT00212355|BG000|Baseline|NPC-02|"zinc acetate~NPC-02: zinc acetate"
10838954|NCT00212355|FG000|Participant Flow|NPC-02|"zinc acetate~NPC-02: zinc acetate"
10838955|NCT00212355|OG000|Outcome|NPC-02|"zinc acetate~NPC-02: zinc acetate"
10838956|NCT00212355|EG000|Reported Event|NPC-02|"zinc acetate~NPC-02: zinc acetate"
10838957|NCT00212446|BG000|Baseline|Electrical Intervention|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
10838958|NCT00212446|FG000|Participant Flow|Electrical Intervention|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
10838959|NCT00212446|OG000|Outcome|Electrical Intervention|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
10838960|NCT00212446|EG000|Reported Event|Electrical Intervention|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
10838961|NCT00212758|BG000|Baseline|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
10838962|NCT00212758|FG000|Participant Flow|Low-standard-standard GH|This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.
10838963|NCT00212758|FG001|Participant Flow|Standard- Low- Standard GH|This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
10838964|NCT00212758|OG000|Outcome|Low Dose GH|Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.
10838965|NCT00212758|OG001|Outcome|Standard Dose GH|Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
10838966|NCT00212758|OG000|Outcome|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
10838967|NCT00212758|EG000|Reported Event|All Participants|There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
10838968|NCT00212888|BG000|Baseline|ALVAC With Remune|Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838969|NCT00212888|BG001|Baseline|ALVAC With Remune Placebo|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838970|NCT00212888|BG002|Baseline|Both Placebos|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838971|NCT00212888|BG003|Baseline|Total|Total of all reporting groups
10838972|NCT00212888|FG000|Participant Flow|ALVAC With Remune|Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838973|NCT00212888|FG001|Participant Flow|ALVAC With Remune Placebo|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838974|NCT00212888|FG002|Participant Flow|Both Placebos|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838975|NCT00212888|OG000|Outcome|ALVAC With Remune|Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838976|NCT00212888|OG001|Outcome|Both Placebos|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838977|NCT00212888|OG000|Outcome|ALVAC With Remune Placebo|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838978|NCT00212888|OG001|Outcome|ALVAC With Remune Placebo|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838979|NCT00212888|OG002|Outcome|Both Placebos|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838980|NCT00212888|EG000|Reported Event|ALVAC With Remune|Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838981|NCT00212888|EG001|Reported Event|ALVAC With Remune Placebo|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838982|NCT00212888|EG002|Reported Event|Both Placebos|Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
10838983|NCT00213135|BG000|Baseline|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
10838984|NCT00213135|BG001|Baseline|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
10838985|NCT00213135|BG002|Baseline|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
10838986|NCT00213135|BG003|Baseline|Total|Total of all reporting groups
10838987|NCT00213135|FG000|Participant Flow|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
10838988|NCT00213135|FG001|Participant Flow|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
10838989|NCT00213135|FG002|Participant Flow|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
10838990|NCT00213135|OG000|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
10838991|NCT00213135|OG001|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
10838992|NCT00213135|OG002|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
10838993|NCT00213135|EG000|Reported Event|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
10838994|NCT00213135|EG001|Reported Event|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
10838995|NCT00213135|EG002|Reported Event|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
10838996|NCT00213148|BG000|Baseline|Clomiphene Citrate 50 mg|Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm.
10838997|NCT00213148|BG001|Baseline|Anastrozole 1 mg|Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm.
10838998|NCT00213148|BG002|Baseline|Anastrozole 5 mg|Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm.
10838999|NCT00213148|BG003|Baseline|Anastrozole 10 mg|Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm.
10839000|NCT00213148|BG004|Baseline|Total|Total of all reporting groups
10839001|NCT00213148|FG000|Participant Flow|Clomiphene Citrate 50 Milligram (mg)|Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm.
10839002|NCT00213148|FG001|Participant Flow|Clomiphene Citrate 100 mg|Subjects from Clomiphene Citrate 50 mg arm who were re-randomized at the start of Cycle 2 and Cycle 3 and were administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month) were presented.
10839003|NCT00213148|FG002|Participant Flow|Anastrozole 1 mg|Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm.
10839004|NCT00213148|FG003|Participant Flow|Anastrozole 5 mg|Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm.
10839005|NCT00213148|FG004|Participant Flow|Anastrozole 10 mg|Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm.
10839006|NCT00213148|OG000|Outcome|Clomiphene Citrate 50 mg|Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1.
10839007|NCT00213148|OG001|Outcome|Anastrozole 1 mg|Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1.
10839008|NCT00213148|OG002|Outcome|Anastrozole 5 mg|Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.
10839009|NCT00213148|OG003|Outcome|Anastrozole 10 mg|Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.
10839010|NCT00213148|EG000|Reported Event|Clomiphene Citrate 50 mg (Cycle 1)|Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 1 were presented.
10839011|NCT00213148|EG001|Reported Event|Anastrozole 1 mg (Cycle 1)|Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 1 were presented.
10839012|NCT00213148|EG002|Reported Event|Anastrozole 5 mg (Cycle 1)|Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 1 were presented.
10839013|NCT00213148|EG003|Reported Event|Anastrozole 10 mg (Cycle 1)|Subjects administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 1 were presented.
10839014|NCT00213148|EG004|Reported Event|Clomiphene Citrate 50 mg (Cycle 2)|Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 2 were presented.
10839015|NCT00213148|EG005|Reported Event|Clomiphene Citrate 100 mg (Cycle 2)|Subjects administered orally with 100 mg of clomiphene citrate once daily for 5 days in cycle 2 were presented.
10839016|NCT00213148|EG006|Reported Event|Anastrozole 1 mg (Cycle 2)|Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 2 were presented.
10839017|NCT00213148|EG007|Reported Event|Anastrozole 5 mg (Cycle 2)|Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 2 were presented.
10839018|NCT00213148|EG008|Reported Event|Anastrozole 10 mg (Cycle 2)|Subjects administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 2 were presented.
10839019|NCT00213148|EG009|Reported Event|Clomiphene Citrate 50 mg (Cycle 3)|Subjects administered orally with 50 mg of clomiphene citrate once daily for 5 days in cycle 3 were presented.
10839020|NCT00213148|EG010|Reported Event|Clomiphene Citrate 100 mg (Cycle 3)|Subjects administered orally with 100 mg of clomiphene citrate once daily for 5 days in cycle 3 were presented.
10839021|NCT00213148|EG011|Reported Event|Anastrozole 1 mg (Cycle 3)|Subjects administered orally with 1 mg of Anastrozole once daily for 5 days in cycle 3 were presented.
10839022|NCT00213148|EG012|Reported Event|Anastrozole 5 mg (Cycle 3)|Subjects administered orally with 5 mg of Anastrozole once daily for 5 days in cycle 3 were presented.
10839023|NCT00213148|EG013|Reported Event|Anastrozole 10 mg (Cycle 3)|Subjects were administered orally with 10 mg of Anastrozole once daily for 5 days in cycle 3 were presented.
10839024|NCT00213239|BG000|Baseline|Propofol 4mg/kg|Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839025|NCT00213239|BG001|Baseline|Propofol 2mg/kg|Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839026|NCT00213239|BG002|Baseline|Total|Total of all reporting groups
10839027|NCT00213239|FG000|Participant Flow|Propofol 4 mg/kg|Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839028|NCT00213239|FG001|Participant Flow|Propofol 2mg/kg|Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839029|NCT00213239|OG000|Outcome|2.0 mg/kg Propofol|Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839030|NCT00213239|OG001|Outcome|4.0 mg/kg Propofol|Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839031|NCT00213239|EG000|Reported Event|Propofol 4 mg/kg|Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839032|NCT00213239|EG001|Reported Event|Propofol 2mg/kg|Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
10839033|NCT00213980|BG000|Baseline|Observation|Observation only for 12 months
10839034|NCT00213980|BG001|Baseline|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
10839035|NCT00213980|BG002|Baseline|Total|Total of all reporting groups
10839036|NCT00213980|FG000|Participant Flow|Observation|Observation only for 12 months
10839037|NCT00213980|FG001|Participant Flow|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
10839038|NCT00213980|OG000|Outcome|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
10839039|NCT00213980|OG001|Outcome|Observation|Observation only for 12 months
10839040|NCT00213980|EG000|Reported Event|Observation|Observation only for 12 months
10839041|NCT00213980|EG001|Reported Event|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
10839042|NCT00214019|BG000|Baseline|4 Way Cross Over|"Participants completed all 4 arms:~Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone,"
10839043|NCT00214019|FG000|Participant Flow|All Study Participants|All participants completed all 4 arms of the study. 28 days per arm.
10839044|NCT00214019|OG000|Outcome|Placebo/Placebo|Participants on Placebo/Placebo arm
10839045|NCT00214019|OG001|Outcome|Placebo/Salmeterol|Participants on Placebo/Salmeterol arm
10839046|NCT00214019|OG002|Outcome|Placebo/fFuticasone|Participants on Placebo/Fluticasone arm
10839047|NCT00214019|OG003|Outcome|Salmeterol/Fluticasone|Participants on Salmeterol/Fluticasone
10839048|NCT00214019|EG000|Reported Event|4 Way Cross Over|"Participants completed all 4 treatments:~Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone"
10839049|NCT00214045|BG000|Baseline|Flexible Cystoscopy|Use of Flexible Cystoscope during clinically indicated cystoscopy
10839050|NCT00214045|BG001|Baseline|Rigid Cystoscopy|Use of Rigid Cystoscope during clinically indicated cystoscopy
10839051|NCT00214045|BG002|Baseline|Total|Total of all reporting groups
10839052|NCT00214045|FG000|Participant Flow|Flexible Cystoscopy|Use of Flexible Cystoscope during clinically indicated cystoscopy
10839053|NCT00214045|FG001|Participant Flow|Rigid Cystoscopy|Use of Rigid Cystoscope during clinically indicated cystoscopy
10839054|NCT00214045|OG000|Outcome|Rigid|Rigid
10839055|NCT00214045|OG001|Outcome|Flexible|Flexible
10839056|NCT00214045|EG000|Reported Event|Flexible Cystoscopy|Use of Flexible Cystoscope during clinically indicated cystoscopy
10839057|NCT00214045|EG001|Reported Event|Rigid Cystoscopy|Use of Rigid Cystoscope during clinically indicated cystoscopy
10842924|NCT00250588|BG000|Baseline|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
10842925|NCT00250588|BG001|Baseline|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
10842926|NCT00250588|BG002|Baseline|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
10842927|NCT00250588|BG003|Baseline|Total|Total of all reporting groups
10842928|NCT00250588|FG000|Participant Flow|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
10842929|NCT00250588|FG001|Participant Flow|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
10842930|NCT00250588|FG002|Participant Flow|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
10842931|NCT00250588|OG000|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
10843326|NCT00253708|BG000|Baseline|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10843327|NCT00253708|BG001|Baseline|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10839058|NCT00214097|BG000|Baseline|Level I|"2.94 gy/fr, 22 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839059|NCT00214097|BG001|Baseline|Level II|"3.63 gy/fr, 16 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839060|NCT00214097|BG002|Baseline|Level III|"4.3 gy/fr, 12 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839061|NCT00214097|BG003|Baseline|Total|Total of all reporting groups
10839062|NCT00214097|FG000|Participant Flow|Level 1|"2.94 gy/fr, 22 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839063|NCT00214097|FG001|Participant Flow|Level 2|"3.63 gy/fr, 16 fractions, 50 patients first 10 treated with 4 fractions per week next 40 treated with 5 fractions per week~Radiotherapy: Daily radiation to prescribed dose"
10839064|NCT00214097|FG002|Participant Flow|Level 3|"4.3 gy/fr, 12 fractions, 50 patients first 10 treated with 4 fractions per week next 40 treated with 5 fractions per week~Radiotherapy: Daily radiation to prescribed dose"
10839065|NCT00214097|OG000|Outcome|Level 1|"2.94 gy/fr, 22 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839066|NCT00214097|OG001|Outcome|Level 2|"3.63 gy/fr, 16 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839067|NCT00214097|OG002|Outcome|Level 3|"4.3 gy/fr, 12 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839068|NCT00214097|OG000|Outcome|Level I|"2.94 gy/fr, 22 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839069|NCT00214097|OG001|Outcome|Level II|"3.63 gy/fr, 16 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839070|NCT00214097|OG002|Outcome|Level III|"4.3 gy/fr, 12 fractions,~Radiotherapy: Daily radiation to prescribed dose"
10839071|NCT00214097|OG000|Outcome|Level I|"2.94 gy/fr, 22 fractions~Radiotherapy: Daily radiation to prescribed dose"
10839072|NCT00214097|OG001|Outcome|Level II|"3.63 gy/fr, 16 fractions~Radiotherapy: Daily radiation to prescribed dose"
10839073|NCT00214097|OG002|Outcome|Level III|"4.3 gy/fr, 12 fractions~Radiotherapy: Daily radiation to prescribed dose"
10839074|NCT00214097|EG000|Reported Event|Level 1|"2.94 gy/fr, 22 fractions, minimum 50 patients to escalate, (back filling permitted while next dose level data matures for escalation) first 10 treated with 4 fractions per week next 40 + treated with 5 fractions per week~Radiotherapy: Daily radiation to prescribed dose"
10839075|NCT00214097|EG001|Reported Event|Level 2|"3.63 gy/fr, 16 fractions, minimum 50 patients ( back filling permitted while next dose level data matures for escalation) first 10 treated with 4 fractions per week next 40 + treated with 5 fractions per week~Radiotherapy: Daily radiation to prescribed dose"
10839076|NCT00214097|EG002|Reported Event|Level 3|"4.3 gy/fr, 12 fractions, 50 patients, for safety, up to an additional 100 for phase II component of study first 10 treated with 4 fractions per week next 40 +treated with 5 fractions per week~Radiotherapy: Daily radiation to prescribed dose"
10839077|NCT00214136|BG000|Baseline|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
10839078|NCT00214136|FG000|Participant Flow|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
10839079|NCT00214136|OG000|Outcome|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
10839080|NCT00214136|EG000|Reported Event|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
10839081|NCT00214201|BG000|Baseline|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
10839082|NCT00214201|BG001|Baseline|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
10839083|NCT00214201|BG002|Baseline|Total|Total of all reporting groups
10839084|NCT00214201|FG000|Participant Flow|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
10839085|NCT00214201|FG001|Participant Flow|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
10839086|NCT00214201|OG000|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
10839087|NCT00214201|OG001|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
10839088|NCT00214201|OG000|Outcome|CNI Control Post Campath 1H|Standard of care CNI Immunosuppression
10839089|NCT00214201|EG000|Reported Event|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
10839090|NCT00214201|EG001|Reported Event|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
10839091|NCT00214383|BG000|Baseline|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
10839092|NCT00214383|BG001|Baseline|Control|Control-usual care
10839093|NCT00214383|BG002|Baseline|Total|Total of all reporting groups
10839094|NCT00214383|FG000|Participant Flow|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
10839095|NCT00214383|FG001|Participant Flow|Control|Control-usual care
10839096|NCT00214383|OG000|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
10839097|NCT00214383|OG001|Outcome|Control|Control-usual care
10839098|NCT00214383|EG000|Reported Event|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
10839099|NCT00214383|EG001|Reported Event|Control|Control-usual care
10839100|NCT00214422|BG000|Baseline|Arm 1- 5040cGy to the Lymph Nodes|"5040 Gray (cGy) to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839101|NCT00214422|BG001|Baseline|Arm 2 - 5400cGy to the Lymph Nodes|"5400cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839102|NCT00214422|BG002|Baseline|Arm 3 - 5900cGy to the Lymph Nodes|"5900cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839103|NCT00214422|BG003|Baseline|Total|Total of all reporting groups
10839104|NCT00214422|FG000|Participant Flow|Arm 1- 5040cGy to the Lymph Nodes|"5040 Gray (cGy) to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839105|NCT00214422|FG001|Participant Flow|Arm 2 - 5400cGy to the Lymph Nodes|"5400cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839106|NCT00214422|FG002|Participant Flow|Arm 3 - 5900cGy to the Lymph Nodes|"5900cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839107|NCT00214422|OG000|Outcome|Arm 1- 5040cGy to the Lymph Nodes|"5040 Gray (cGy) to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839108|NCT00214422|OG001|Outcome|Arm 2 - 5400cGy to the Lymph Nodes|Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
10839109|NCT00214422|OG002|Outcome|Arm 3 - 5900cGY to the Lymph Nodes|Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
10839110|NCT00214422|OG001|Outcome|Arm 2 - 5400cGy to the Lymph Nodes|"5400cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839111|NCT00214422|OG002|Outcome|Arm 3 - 5900cGy to the Lymph Nodes|"5900cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839112|NCT00214422|OG001|Outcome|Arm 2 - 5400cGy to the Lymph Nodes|"5400cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes."
10839113|NCT00214422|OG002|Outcome|Arm 3 - 5900cGY to the Lymph Nodes|"5900cGy to the lymph nodes~Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes."
10839114|NCT00214422|EG000|Reported Event|Arm 1- 5040cGy to the Lymph Nodes|"5040 Gray (cGy) to the lymph nodes~External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839115|NCT00214422|EG001|Reported Event|Arm 2 - 5400cGy to the Lymph Nodes|"5400cGy to the lymph nodes~External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839116|NCT00214422|EG002|Reported Event|Arm 3 - 5900cGy to the Lymph Nodes|"5900cGy to the lymph nodes~External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes."
10839117|NCT00214461|BG000|Baseline|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
10839118|NCT00214461|BG001|Baseline|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839119|NCT00214461|BG002|Baseline|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839120|NCT00214461|BG003|Baseline|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
10839121|NCT00214461|BG004|Baseline|Total|Total of all reporting groups
10839122|NCT00214461|FG000|Participant Flow|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
10839123|NCT00214461|FG001|Participant Flow|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839124|NCT00214461|FG002|Participant Flow|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839125|NCT00214461|FG003|Participant Flow|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
10839126|NCT00214461|OG000|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
10839127|NCT00214461|OG001|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839128|NCT00214461|OG002|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839129|NCT00214461|OG003|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
10839130|NCT00214461|EG000|Reported Event|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
10839131|NCT00214461|EG001|Reported Event|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839132|NCT00214461|EG002|Reported Event|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
10839133|NCT00214461|EG003|Reported Event|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
10839134|NCT00214487|BG000|Baseline|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
10839135|NCT00214487|BG001|Baseline|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
10839136|NCT00214487|BG002|Baseline|Total|Total of all reporting groups
10839137|NCT00214487|FG000|Participant Flow|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
10839138|NCT00214487|FG001|Participant Flow|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
10839139|NCT00214487|OG000|Outcome|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
10839140|NCT00214487|OG001|Outcome|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
10839141|NCT00214487|EG000|Reported Event|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
10839142|NCT00214487|EG001|Reported Event|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
10839143|NCT00214526|BG000|Baseline|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839144|NCT00214526|BG001|Baseline|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839145|NCT00214526|BG002|Baseline|Total|Total of all reporting groups
10839146|NCT00214526|FG000|Participant Flow|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839147|NCT00214526|FG001|Participant Flow|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839148|NCT00214526|OG000|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839149|NCT00214526|OG001|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
10839150|NCT00214526|EG000|Reported Event|Alair (Treatment Period)|From first Treatment visit through 6 weeks after last Treatment visit.
10839151|NCT00214526|EG001|Reported Event|Control (Treatment Period)|From first Control visit through 6 weeks after last Control visit.
10839152|NCT00214526|EG002|Reported Event|Alair (Post-Treatment Period)|From 6 weeks after last Treatment visit through 1 year.
10839153|NCT00214526|EG003|Reported Event|Control (Post-Treatment Period)|From 6 weeks after last Control visit through 1 year.
10839154|NCT00214539|BG000|Baseline|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
10839155|NCT00214539|BG001|Baseline|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
10839156|NCT00214539|BG002|Baseline|Total|Total of all reporting groups
10839157|NCT00214539|FG000|Participant Flow|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
10839158|NCT00214539|FG001|Participant Flow|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
10839159|NCT00214539|OG000|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
10839160|NCT00214539|OG001|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
10839161|NCT00214539|EG000|Reported Event|Alair (Treatment Period)|
10839162|NCT00214539|EG001|Reported Event|Control (Treatment Period)|
10839163|NCT00214539|EG002|Reported Event|Alair (Steroid Stable Phase)|
10839164|NCT00214539|EG003|Reported Event|Control (Steroid Stable Phase)|
10839165|NCT00214539|EG004|Reported Event|Alair (Steroid Wean and Reduced Steroid Phases)|
10839166|NCT00214539|EG005|Reported Event|Control (Steroid Wean and Reduced Steroid Phases)|
10839167|NCT00214786|BG000|Baseline|Islet Cell|Patients with allogeneic islet cell transplantation
10839168|NCT00214786|FG000|Participant Flow|Islet Cell Transplantation|Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
10839169|NCT00214786|OG000|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
10839170|NCT00214786|EG000|Reported Event|Islet Cell|Patients with allogeneic islet cell transplantation
10839171|NCT00214890|BG000|Baseline|Tenofovir|Monotherapy tenofovir (300mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839172|NCT00214890|BG001|Baseline|Abacavir|Monotherapy abacavir (600mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839173|NCT00214890|BG002|Baseline|Total|Total of all reporting groups
10839174|NCT00214890|FG000|Participant Flow|Tenofovir|Monotherapy tenofovir (300mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839175|NCT00214890|FG001|Participant Flow|Abacavir|Monotherapy abacavir (600mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839176|NCT00214890|OG000|Outcome|Tenofovir|Monotherapy tenofovir (300mg) for 7 days followed by a 35-day washout period then 7 days of TDF + ABC dual therapy
10839177|NCT00214890|OG001|Outcome|Abacavir|Monotherapy abacavir (600mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839178|NCT00214890|EG000|Reported Event|Tenofovir|Monotherapy tenofovir (300mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839179|NCT00214890|EG001|Reported Event|Abacavir|Monotherapy abacavir (600mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
10839180|NCT00214903|BG000|Baseline|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
10839181|NCT00214903|BG001|Baseline|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
10839182|NCT00214903|BG002|Baseline|ooHRT|Users of oral but not continuous combined HRT preparations
10839183|NCT00214903|BG003|Baseline|Non-oral HRT|Users of non-oral HRT preparations
10839184|NCT00214903|BG004|Baseline|Total|Total of all reporting groups
10839185|NCT00214903|FG000|Participant Flow|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
10839186|NCT00214903|FG001|Participant Flow|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
10839187|NCT00214903|FG002|Participant Flow|ooHRT|Users of oral but not continuous combined HRT preparations
10839188|NCT00214903|FG003|Participant Flow|Non-oral HRT|Users of non-oral HRT preparations
10839189|NCT00214903|OG000|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
10839190|NCT00214903|OG001|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
10839191|NCT00214903|OG002|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
10839192|NCT00214903|OG003|Outcome|Non-oral HRT|Users of non-oral HRT preparations
10839193|NCT00214903|EG000|Reported Event|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
10839194|NCT00214903|EG001|Reported Event|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
10839195|NCT00214903|EG002|Reported Event|ooHRT|Users of oral but not continuous combined HRT preparations
10839196|NCT00214903|EG003|Reported Event|Non-oral HRT|Users of non-oral HRT preparations
10839197|NCT00215137|BG000|Baseline|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
10839198|NCT00215137|FG000|Participant Flow|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
10839199|NCT00215137|FG001|Participant Flow|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
10839200|NCT00215137|FG002|Participant Flow|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
10839201|NCT00215137|OG000|Outcome|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
10839202|NCT00215137|OG001|Outcome|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
10839203|NCT00215137|OG002|Outcome|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
10839204|NCT00215137|EG000|Reported Event|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
10839205|NCT00215137|EG001|Reported Event|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
10839206|NCT00215137|EG002|Reported Event|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
10839207|NCT00215150|BG000|Baseline|Study Treatment|8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
10839208|NCT00215150|FG000|Participant Flow|Open Label Treatment|8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
10839209|NCT00215150|OG000|Outcome|Open Label Phase|The open label treatment phase for the first 8 weeks
10839210|NCT00215150|OG001|Outcome|Randomization Phase for Ziprasidone Group|The group of subjects randomized to receive Ziprasidone for the second 8 weeks
10839211|NCT00215150|OG002|Outcome|Randomization Phase for Placebo Group|The group of subjects randomized to receive placebo for the second 8 weeks
10839212|NCT00215150|EG000|Reported Event|Open Label Phase|The first 8 weeks of treatment on sertraline
10839213|NCT00215150|EG001|Reported Event|Randomization Phase for Ziprasidone|The second phase of treatment with subjects randomized to ziprasidone augmentation.
10839214|NCT00215150|EG002|Reported Event|Randomization Phase for Placebo|The second phase of treatment with subjects randomized to placebo augmentation.
10839215|NCT00215540|BG000|Baseline|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
10839216|NCT00215540|BG001|Baseline|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
10839217|NCT00215540|BG002|Baseline|Placebo|Sham air using 3.0 mL/kg volume of air
10839218|NCT00215540|BG003|Baseline|Total|Total of all reporting groups
10839219|NCT00215540|FG000|Participant Flow|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
10839220|NCT00215540|FG001|Participant Flow|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
10839221|NCT00215540|FG002|Participant Flow|Placebo|Sham air using 3.0 mL/kg volume of air
10839222|NCT00215540|OG000|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
10839223|NCT00215540|OG001|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
10839224|NCT00215540|OG002|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
10839225|NCT00215540|EG000|Reported Event|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
10839226|NCT00215540|EG001|Reported Event|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
10839227|NCT00215540|EG002|Reported Event|Placebo|Sham air using 3.0 mL/kg volume of air
10839228|NCT00215553|BG000|Baseline|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
10839229|NCT00215553|BG001|Baseline|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839230|NCT00215553|BG002|Baseline|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839231|NCT00215553|BG003|Baseline|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839232|NCT00215553|BG004|Baseline|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839233|NCT00215553|BG005|Baseline|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839234|NCT00215553|BG006|Baseline|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
10839235|NCT00215553|BG007|Baseline|Total|Total of all reporting groups
10839236|NCT00215553|FG000|Participant Flow|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
10839237|NCT00215553|FG001|Participant Flow|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839238|NCT00215553|FG002|Participant Flow|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839239|NCT00215553|FG003|Participant Flow|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839240|NCT00215553|FG004|Participant Flow|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839241|NCT00215553|FG005|Participant Flow|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839242|NCT00215553|FG006|Participant Flow|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
10839243|NCT00215553|OG000|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
10839244|NCT00215553|OG001|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839245|NCT00215553|OG002|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839246|NCT00215553|OG003|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839247|NCT00215553|OG004|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839248|NCT00215553|OG005|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839249|NCT00215553|OG006|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
10839250|NCT00215553|EG000|Reported Event|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
10839251|NCT00215553|EG001|Reported Event|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839252|NCT00215553|EG002|Reported Event|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839253|NCT00215553|EG003|Reported Event|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839254|NCT00215553|EG004|Reported Event|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
10839255|NCT00215553|EG005|Reported Event|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
10839256|NCT00215553|EG006|Reported Event|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
10839257|NCT00215644|BG000|Baseline|Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab|Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.
10839258|NCT00215644|BG001|Baseline|ECX Only|Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.
10839259|NCT00215644|BG002|Baseline|Total|Total of all reporting groups
10839260|NCT00215644|FG000|Participant Flow|Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab|Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.
10839261|NCT00215644|FG001|Participant Flow|ECX Only|Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.
10839262|NCT00215644|OG000|Outcome|Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab|Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.
10839263|NCT00215644|OG001|Outcome|ECX Only|Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.
10839264|NCT00215644|EG000|Reported Event|Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab|Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.
10839265|NCT00215644|EG001|Reported Event|ECX Only|Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.
10839266|NCT00215657|BG000|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10839267|NCT00215657|BG001|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10839268|NCT00215657|BG002|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10839269|NCT00215657|BG003|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10839270|NCT00215657|BG004|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10839271|NCT00215657|BG005|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10839272|NCT00215657|BG006|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10839273|NCT00215657|BG007|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10839274|NCT00215657|BG008|Baseline|Total|Total of all reporting groups
10839275|NCT00215657|FG000|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10839276|NCT00215657|FG001|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10839277|NCT00215657|FG002|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10839278|NCT00215657|FG003|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10839279|NCT00215657|FG004|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10839280|NCT00215657|FG005|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10839281|NCT00215657|FG006|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10839282|NCT00215657|FG007|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10839283|NCT00215657|OG000|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10839284|NCT00215657|OG001|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10839285|NCT00215657|OG002|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10839286|NCT00215657|OG003|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10839287|NCT00215657|OG004|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10839288|NCT00215657|OG005|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10839289|NCT00215657|OG006|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10839290|NCT00215657|OG007|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10839291|NCT00215657|EG000|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
10839292|NCT00215657|EG001|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
10839293|NCT00215657|EG002|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
10839294|NCT00215657|EG003|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
10839295|NCT00215657|EG004|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
10839296|NCT00215657|EG005|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
10839297|NCT00215657|EG006|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
10839298|NCT00215657|EG007|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
10839299|NCT00215683|BG000|Baseline|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839300|NCT00215683|BG001|Baseline|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839301|NCT00215683|BG002|Baseline|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839302|NCT00215683|BG003|Baseline|Total|Total of all reporting groups
10839303|NCT00215683|FG000|Participant Flow|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839304|NCT00215683|FG001|Participant Flow|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839305|NCT00215683|FG002|Participant Flow|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839306|NCT00215683|OG000|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839307|NCT00215683|OG001|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839308|NCT00215683|OG002|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839309|NCT00215683|EG000|Reported Event|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839310|NCT00215683|EG001|Reported Event|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839311|NCT00215683|EG002|Reported Event|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
10839312|NCT00215787|BG000|Baseline|Lansoprazole|Lansoprazole 30mg BID for one year
10839313|NCT00215787|FG000|Participant Flow|Lansoprazole|Lansoprazole 30mg BID for one year
10839314|NCT00215787|OG000|Outcome|Lansoprazole|Lansoprazole 30mg BID for one year
10839315|NCT00215787|EG000|Reported Event|Lansoprazole|Lansoprazole 30mg BID for one year
10839316|NCT00215930|BG000|Baseline|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
10839317|NCT00215930|FG000|Participant Flow|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
10839318|NCT00215930|OG000|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression. Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
10839319|NCT00215930|OG000|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
10839320|NCT00215930|EG000|Reported Event|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
10839321|NCT00215943|BG000|Baseline|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
10839322|NCT00215943|BG001|Baseline|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
10839323|NCT00215943|BG002|Baseline|Total|Total of all reporting groups
10843328|NCT00253708|BG002|Baseline|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
10843329|NCT00253708|BG003|Baseline|Total|Total of all reporting groups
10839324|NCT00215943|FG000|Participant Flow|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
10839325|NCT00215943|FG001|Participant Flow|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
10839326|NCT00215943|OG000|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
10839327|NCT00215943|OG001|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
10839328|NCT00215943|EG000|Reported Event|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
10839329|NCT00215943|EG001|Reported Event|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
10839330|NCT00216060|BG000|Baseline|Risedronate|Daily oral risedronate combined with androgen deprivation
10839331|NCT00216060|BG001|Baseline|Placebo|daily oral placebo combined with androgen deprivation
10839332|NCT00216060|BG002|Baseline|Total|Total of all reporting groups
10839333|NCT00216060|FG000|Participant Flow|Risedronate|Daily oral risedronate combined with androgen deprivation
10839334|NCT00216060|FG001|Participant Flow|Placebo|daily oral placebo combined with androgen deprivation
10839335|NCT00216060|OG000|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
10839336|NCT00216060|OG001|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
10839337|NCT00216060|OG000|Outcome|Risedronate|Daily oral risedronate combined with androgen deprivation
10839338|NCT00216060|OG001|Outcome|Placebo|daily oral placebo combined with androgen deprivation
10839339|NCT00216060|EG000|Reported Event|Placebo|daily oral placebo combined with androgen deprivation
10839340|NCT00216060|EG001|Reported Event|Risedronate|Daily oral risedronate combined with androgen deprivation
10839341|NCT00216086|BG000|Baseline|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
10839342|NCT00216086|FG000|Participant Flow|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
10839343|NCT00216086|OG000|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
10848571|NCT00290498|BG000|Baseline|R-HCVAD/R-MA|I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg & vincristine 1.4mg - 2mg, & oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg & 800mg 22h, & cytarabine 3g.
10839344|NCT00216086|EG000|Reported Event|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
10839345|NCT00216099|BG000|Baseline|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
10839346|NCT00216099|FG000|Participant Flow|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
10839347|NCT00216099|OG000|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
10839348|NCT00216099|EG000|Reported Event|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
10839349|NCT00216125|BG000|Baseline|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
10839350|NCT00216125|FG000|Participant Flow|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
10839351|NCT00216125|FG001|Participant Flow|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
10839352|NCT00216125|FG002|Participant Flow|Observation Only|Patients were followed for Observation.
10839353|NCT00216125|OG000|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
10839354|NCT00216125|OG001|Outcome|Observation Only|Patients were followed for Observation.
10839355|NCT00216125|EG000|Reported Event|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)~Adverse events reported in this arm consist only of participants that were not randomized into the Consolidation Docetaxel or Observation Only arms."
10839356|NCT00216125|EG001|Reported Event|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
10839357|NCT00216125|EG002|Reported Event|Observation Only|Patients were followed for Observation.
10839358|NCT00216203|BG000|Baseline|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
10839359|NCT00216203|FG000|Participant Flow|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
10839360|NCT00216203|OG000|Outcome|Investigational Treatment|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
10839361|NCT00216203|OG000|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
10839362|NCT00216203|EG000|Reported Event|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
10839363|NCT00216320|BG000|Baseline|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
10839364|NCT00216320|BG001|Baseline|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
10839365|NCT00216320|BG002|Baseline|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
10839366|NCT00216320|BG003|Baseline|Total|Total of all reporting groups
10839367|NCT00216320|FG000|Participant Flow|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
10839368|NCT00216320|FG001|Participant Flow|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
10839369|NCT00216320|FG002|Participant Flow|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
10839370|NCT00216320|OG000|Outcome|Subjects Who Used Both WA and AFO|Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
10839371|NCT00216320|OG000|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
10839372|NCT00216320|OG001|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
10839373|NCT00216320|OG002|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
10839374|NCT00216320|EG000|Reported Event|Arm 1|All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
10839375|NCT00216320|EG001|Reported Event|Arm 2|All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
10839376|NCT00216320|EG002|Reported Event|Arm 3|All subjects used AFO for all 12 weeks of study.
10839377|NCT00216476|BG000|Baseline|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
10839378|NCT00216476|BG001|Baseline|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
10839379|NCT00216476|BG002|Baseline|Total|Total of all reporting groups
10839380|NCT00216476|FG000|Participant Flow|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
10839381|NCT00216476|FG001|Participant Flow|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
10839382|NCT00216476|FG002|Participant Flow|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
10839383|NCT00216476|OG000|Outcome|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
10839384|NCT00216476|OG001|Outcome|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
10839385|NCT00216476|OG000|Outcome|Aripiprazole|oral, recommended maintenance dose of 10-30 mg q.d.
10839386|NCT00216476|OG000|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
10839387|NCT00216476|OG001|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
10839388|NCT00216476|OG002|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
10839389|NCT00216476|EG000|Reported Event|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
10839390|NCT00216476|EG001|Reported Event|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
10839391|NCT00216476|EG002|Reported Event|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
10839392|NCT00216671|BG000|Baseline|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
10839393|NCT00216671|BG001|Baseline|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
10839394|NCT00216671|BG002|Baseline|Total|Total of all reporting groups
10839395|NCT00216671|FG000|Participant Flow|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
10839396|NCT00216671|FG001|Participant Flow|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
10839397|NCT00216671|OG000|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
10839398|NCT00216671|OG001|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
10839399|NCT00216671|EG000|Reported Event|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
10839400|NCT00216671|EG001|Reported Event|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
10839401|NCT00216736|BG000|Baseline|Placebo|
10839402|NCT00216736|BG001|Baseline|Dexamethasone|
10839403|NCT00216736|BG002|Baseline|Total|Total of all reporting groups
10839404|NCT00216736|FG000|Participant Flow|Placebo|
10839405|NCT00216736|FG001|Participant Flow|Dexamethasone|
10839406|NCT00216736|OG000|Outcome|Placebo|
10839407|NCT00216736|OG001|Outcome|Dexamethasone|
10839408|NCT00216736|EG000|Reported Event|Placebo|
10839409|NCT00216736|EG001|Reported Event|Dexamethasone|
10839410|NCT00217022|BG000|Baseline|Budesonide|9 mg daily
10839411|NCT00217022|BG001|Baseline|Placebo|three tablets daily
10839412|NCT00217022|BG002|Baseline|Total|Total of all reporting groups
10839413|NCT00217022|FG000|Participant Flow|Budesonide|9 mg daily
10839414|NCT00217022|FG001|Participant Flow|Placebo|three tablets daily
10839415|NCT00217022|OG000|Outcome|Budesonide|9 mg daily
10839416|NCT00217022|OG001|Outcome|Placebo|three tablets daily
10839417|NCT00217022|EG000|Reported Event|Budesonide|9 mg daily
10839418|NCT00217022|EG001|Reported Event|Placebo|three tablets daily
10839419|NCT00217087|BG000|Baseline|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
10839420|NCT00217087|BG001|Baseline|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
10839421|NCT00217087|BG002|Baseline|Total|Total of all reporting groups
10839422|NCT00217087|FG000|Participant Flow|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
10839423|NCT00217087|FG001|Participant Flow|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
10839424|NCT00217087|OG000|Outcome|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
10839425|NCT00217087|OG001|Outcome|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
10839426|NCT00217087|OG000|Outcome|Endoscopic Mucosal Resection FISH Polysomy Negative|FISH cytology results prior to therapy were negative
10839427|NCT00217087|OG001|Outcome|Endoscopic Mucosal Resection FISH Positive Positive|FISH cytology results were positive prior to therapy
10839428|NCT00217087|OG002|Outcome|Photodynamic Therapy FISH POSITIVE|FISH cytology results were positive prior to therapy
10839429|NCT00217087|OG003|Outcome|Photodynamic Therapy FISH NEGATIVE|FISH cytology results prior to therapy were negative
10839430|NCT00217087|OG000|Outcome|Endoscopic Mucosal Resection|Patients will undergo EMR at time of endoscopy if indicated.
10839431|NCT00217087|OG001|Outcome|Endoscopic Mucosal Resection and Photodynamic Therapy|Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy
10839432|NCT00217087|EG000|Reported Event|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
10839433|NCT00217087|EG001|Reported Event|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
10839434|NCT00217399|BG000|Baseline|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
10839435|NCT00217399|FG000|Participant Flow|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
10839436|NCT00217399|OG000|Outcome|Sorafenib and Anastrozole|All patients receive sorafenib and anastrozole.
10839437|NCT00217399|OG000|Outcome|Sorefenib and Anastrozole|All patients receive sorafenib (400mg by mouth twice daily) and anastrazole (1 mg by mouth daily)
10839438|NCT00217399|OG000|Outcome|Circulating Endothelial Cells|All patients received sorafenib and anastrozole. Blood was drawn prior to beginning treatment and at set time points to analyze for circulating endothelial cells by flow cytometry
10839439|NCT00217399|EG000|Reported Event|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
10839440|NCT00217425|BG000|Baseline|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
10839441|NCT00217425|FG000|Participant Flow|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
10839442|NCT00217425|OG000|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
10839443|NCT00217425|EG000|Reported Event|Treatment (ACHOP Followed by MA)|Adverse events in all treated patients regardless of eligibility.
10848184|NCT00289016|EG000|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
10839444|NCT00217438|BG000|Baseline|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839445|NCT00217438|BG001|Baseline|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839446|NCT00217438|BG002|Baseline|Total|Total of all reporting groups
10839447|NCT00217438|FG000|Participant Flow|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839448|NCT00217438|FG001|Participant Flow|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839449|NCT00217438|OG000|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839450|NCT00217438|OG001|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839451|NCT00217438|EG000|Reported Event|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839452|NCT00217438|EG001|Reported Event|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
10839453|NCT00217464|BG000|Baseline|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
10839454|NCT00217464|FG000|Participant Flow|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
10839455|NCT00217464|OG000|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
10839456|NCT00217464|EG000|Reported Event|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
10839457|NCT00217490|BG000|Baseline|Computer Only|Dietary Counseling delivered by interactive computer
10839458|NCT00217490|BG001|Baseline|Counseling Only|Dietary counseling delivered by nutritionist
10839459|NCT00217490|BG002|Baseline|Combined|Dietary counseling delivered using computer program and nutritionist
10839460|NCT00217490|BG003|Baseline|Physcial Activity-computer|Physical activity counseling delivered by computer only
10839461|NCT00217490|BG004|Baseline|Total|Total of all reporting groups
10839462|NCT00217490|FG000|Participant Flow|Computer Only|Dietary Counseling delivered by interactive computer
10839463|NCT00217490|FG001|Participant Flow|Counseling Only|Dietary counseling delivered by nutritionist
10839464|NCT00217490|FG002|Participant Flow|Combined|Dietary counseling delivered using computer program and nutritionist
10839465|NCT00217490|FG003|Participant Flow|Physcial Activity-computer|Physical activity counseling delivered by computer only
10839466|NCT00217490|OG000|Outcome|Computer Only|"Dietary Counseling delivered by interactive computer~dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
10839467|NCT00217490|OG001|Outcome|Counseling Only|"Dietary counseling delivered by nutritionist~dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
10839468|NCT00217490|OG002|Outcome|Combined|"Dietary counseling delivered using computer program and nutritionist~combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
10839469|NCT00217490|OG003|Outcome|Physcial Activity-computer|"Physical activity counseling delivered by computer only~physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan"
10839470|NCT00217490|OG000|Outcome|Computer Only|Dietary Counseling delivered by interactive computer
10839471|NCT00217490|OG001|Outcome|Counseling Only|Dietary counseling delivered by nutritionist
10839472|NCT00217490|OG002|Outcome|Combined|Dietary counseling delivered using computer program and nutritionist
10839473|NCT00217490|OG003|Outcome|Physcial Activity-computer|Physical activity counseling delivered by computer only
10839474|NCT00217490|EG000|Reported Event|Computer Only|Dietary Counseling delivered by interactive computer
10839475|NCT00217490|EG001|Reported Event|Counseling Only|Dietary counseling delivered by nutritionist
10839476|NCT00217490|EG002|Reported Event|Combined|Dietary counseling delivered using computer program and nutritionist
10839477|NCT00217490|EG003|Reported Event|Physcial Activity-computer|Physical activity counseling delivered by computer only
10839478|NCT00217581|BG000|Baseline|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
10839479|NCT00217581|FG000|Participant Flow|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
10839480|NCT00217581|OG000|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
10839481|NCT00217581|OG000|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
10839482|NCT00217581|EG000|Reported Event|Docetaxel, Oxaliplatin & Bevacizumab|"Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Bevacizumab: Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
10839483|NCT00217594|BG000|Baseline|Alemtuzumab|Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
10839484|NCT00217594|FG000|Participant Flow|Alemtuzumab|Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
10839485|NCT00217594|OG000|Outcome|Alemtuzumab|Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
10839486|NCT00217594|EG000|Reported Event|Alemtuzumab|Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
10839487|NCT00217620|BG000|Baseline|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839488|NCT00217620|FG000|Participant Flow|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839489|NCT00217620|OG000|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839490|NCT00217620|OG001|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839491|NCT00217620|OG002|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839492|NCT00217620|OG003|Outcome|Total|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839493|NCT00217620|OG000|Outcome|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839494|NCT00217620|EG000|Reported Event|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
10839495|NCT00217672|BG000|Baseline|Docetaxel + Bevacizumab|"docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.~A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.~Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients."
10839496|NCT00217672|FG000|Participant Flow|Docetaxel+Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
10839497|NCT00217672|FG001|Participant Flow|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
10839498|NCT00217672|OG000|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
10839499|NCT00217672|EG000|Reported Event|Docetaxel and/or Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
10839500|NCT00217724|BG000|Baseline|Entire Study Population|Includes those randomized to Arms 1 and 2 in both course 1 and 2.
10839501|NCT00217724|FG000|Participant Flow|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
10839502|NCT00217724|FG001|Participant Flow|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
10839503|NCT00217724|OG000|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
10839504|NCT00217724|OG001|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
10839505|NCT00217724|EG000|Reported Event|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
10839506|NCT00217724|EG001|Reported Event|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
10839507|NCT00217971|BG000|Baseline|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
10839508|NCT00217971|BG001|Baseline|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
10839509|NCT00217971|BG002|Baseline|Total|Total of all reporting groups
10839510|NCT00217971|FG000|Participant Flow|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
10839511|NCT00217971|FG001|Participant Flow|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
10839512|NCT00217971|OG000|Outcome|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
10839513|NCT00217971|OG001|Outcome|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
10839514|NCT00217971|EG000|Reported Event|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
10839515|NCT00217971|EG001|Reported Event|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
10839516|NCT00218023|BG000|Baseline|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839517|NCT00218023|BG001|Baseline|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839518|NCT00218023|BG002|Baseline|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839519|NCT00218023|BG003|Baseline|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839520|NCT00218023|BG004|Baseline|Total|Total of all reporting groups
10839521|NCT00218023|FG000|Participant Flow|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839522|NCT00218023|FG001|Participant Flow|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839523|NCT00218023|FG002|Participant Flow|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839524|NCT00218023|FG003|Participant Flow|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839525|NCT00218023|OG000|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10848185|NCT00289094|BG000|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10848186|NCT00289094|BG001|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10848187|NCT00289094|BG002|Baseline|Total|Total of all reporting groups
10848188|NCT00289094|FG000|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10839526|NCT00218023|OG001|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839527|NCT00218023|OG002|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839528|NCT00218023|OG003|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839529|NCT00218023|EG000|Reported Event|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839530|NCT00218023|EG001|Reported Event|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839531|NCT00218023|EG002|Reported Event|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839532|NCT00218023|EG003|Reported Event|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
10839533|NCT00218062|BG000|Baseline|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839534|NCT00218062|BG001|Baseline|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839535|NCT00218062|BG002|Baseline|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839536|NCT00218062|BG003|Baseline|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839537|NCT00218062|BG004|Baseline|Total|Total of all reporting groups
10839538|NCT00218062|FG000|Participant Flow|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839539|NCT00218062|FG001|Participant Flow|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839540|NCT00218062|FG002|Participant Flow|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839541|NCT00218062|FG003|Participant Flow|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839542|NCT00218062|OG000|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839543|NCT00218062|OG001|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839544|NCT00218062|OG002|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839545|NCT00218062|OG003|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839546|NCT00218062|EG000|Reported Event|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839547|NCT00218062|EG001|Reported Event|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10848189|NCT00289094|FG001|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10839548|NCT00218062|EG002|Reported Event|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839549|NCT00218062|EG003|Reported Event|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
10839550|NCT00218257|BG000|Baseline|All Participants|Cross-over design; all participants who completed the first of two inpatient study visits are pooled and reported here
10839551|NCT00218257|FG000|Participant Flow|Progesterone, Then Placebo|
10839552|NCT00218257|FG001|Participant Flow|Placebo, Then Progesterone|
10839553|NCT00218257|OG000|Outcome|Progesterone|Progesterone (200mg, twice daily)
10839554|NCT00218257|OG001|Outcome|Placebo|Placebo (given twice daily)
10839555|NCT00218257|OG000|Outcome|Progesterone|Progesterone (200mg, given twice daily)
10839556|NCT00218257|OG000|Outcome|Progesterone|Progesterone (200mg twice daily)
10839557|NCT00218257|OG000|Outcome|Progesterone|Progesterone (200mg given twice daily)
10839558|NCT00218257|EG000|Reported Event|Progesterone|Progesterone (200mg given twice daily)
10839559|NCT00218257|EG001|Reported Event|Placebo|Placebo (given twice daily)
10839560|NCT00218296|BG000|Baseline|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
10839561|NCT00218296|BG001|Baseline|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
10839562|NCT00218296|BG002|Baseline|Total|Total of all reporting groups
10839563|NCT00218296|FG000|Participant Flow|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.
10839564|NCT00218296|FG001|Participant Flow|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
10839565|NCT00218296|OG000|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
10839566|NCT00218296|OG001|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
10839567|NCT00218296|OG000|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
10839568|NCT00218296|OG001|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
10839569|NCT00218296|EG000|Reported Event|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
10839570|NCT00218296|EG001|Reported Event|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
10839571|NCT00218335|BG000|Baseline|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
10839572|NCT00218335|BG001|Baseline|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
10839573|NCT00218335|BG002|Baseline|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
10839574|NCT00218335|BG003|Baseline|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
10839575|NCT00218335|BG004|Baseline|Total|Total of all reporting groups
10839576|NCT00218335|FG000|Participant Flow|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
10839577|NCT00218335|FG001|Participant Flow|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
10839578|NCT00218335|FG002|Participant Flow|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
10839579|NCT00218335|FG003|Participant Flow|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
10839580|NCT00218335|OG000|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
10839581|NCT00218335|OG001|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
10839582|NCT00218335|OG002|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
10839583|NCT00218335|OG003|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
10839584|NCT00218335|OG000|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
10839585|NCT00218335|OG001|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
10839586|NCT00218335|EG000|Reported Event|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
10839587|NCT00218335|EG001|Reported Event|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
10839588|NCT00218335|EG002|Reported Event|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
10839589|NCT00218335|EG003|Reported Event|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
10839590|NCT00218387|BG000|Baseline|200mg Modafinil|"200mg Modafinil~Modafinil: 200mg Modafinil"
10839591|NCT00218387|BG001|Baseline|400mg Modafinil|"400mg Modafinil~Modafinil: 400mg Modafinil"
10839592|NCT00218387|BG002|Baseline|Matching Placebo|"Matching Placebo~Matching Placebo: Matching Placebo"
10839593|NCT00218387|BG003|Baseline|Total|Total of all reporting groups
10839594|NCT00218387|FG000|Participant Flow|200mg Modafinil|"200mg Modafinil~Modafinil: 200mg Modafinil"
10839595|NCT00218387|FG001|Participant Flow|400mg Modafinil|"400mg Modafinil~Modafinil: 400mg Modafinil"
10839596|NCT00218387|FG002|Participant Flow|Matching Placebo|"Matching Placebo~Matching Placebo: Matching Placebo"
10839597|NCT00218387|OG000|Outcome|200mg Modafinil|"200mg Modafinil~Modafinil: 200mg Modafinil"
10839598|NCT00218387|OG001|Outcome|400mg Modafinil|"400mg Modafinil~Modafinil: 400mg Modafinil"
10839599|NCT00218387|OG002|Outcome|Matching Placebo|"Matching Placebo~Matching Placebo: Matching Placebo"
10839600|NCT00218387|EG000|Reported Event|200mg Modafinil|"200mg Modafinil~Modafinil: 200mg Modafinil"
10839601|NCT00218387|EG001|Reported Event|400mg Modafinil|"400mg Modafinil~Modafinil: 400mg Modafinil"
10839602|NCT00218387|EG002|Reported Event|Matching Placebo|"Matching Placebo~Matching Placebo: Matching Placebo"
10839603|NCT00218426|BG000|Baseline|ONP + DNI|"Oral naltrexone placebo + Depot Naltrexone Implant 1000 mg~naltrexone implant: depot implant is 1000 mg naltrexone~placebo oral tablet: placebo oral tablet resembles active medication"
10839604|NCT00218426|BG001|Baseline|ON + DNIP|"Oral naltrexone 50 mg + Depot Naltrexone placebo Implant~oral naltrexone: oral naltrexone 50 mg/day~depot placebo implant: placebo implant resembles active medication"
10839605|NCT00218426|BG002|Baseline|ONP + DNIP|"Oral placebo naltrexone + placebo naltrexone implant~placebo oral tablet: placebo oral tablet resembles active medication~depot placebo implant: placebo implant resembles active medication"
10839606|NCT00218426|BG003|Baseline|Total|Total of all reporting groups
10839607|NCT00218426|FG000|Participant Flow|ON + DNIP, Oral Naltrexone + Depot Placebo Naltrexone Implant|"Oral naltrexone~Oral naltrexone: oral naltrexone 50 mg/day~DNIP~Depot Placebo Naltrexone Implant"
10839608|NCT00218426|FG001|Participant Flow|DNI + ONP , Naltrexone Implant + Oral Naltrexone Placebo|"naltrexone implant~naltrexone implant: The implant is 1000 mg naltrexone~ONP oral naltrexone placebo tablet"
10839609|NCT00218426|FG002|Participant Flow|ONP + DNIP, Oral Placebo Naltrexone and Depot Placebo Implant|"ONP daily placebo oral naltrexone~monthly placebo depot naltrexone implant"
10839610|NCT00218426|OG000|Outcome|ON + DNIP, Oral Naltrexone + Depot Placebo Naltrexone Implant|"Oral naltrexone~Oral naltrexone: oral naltrexone 50 mg/day~DNIP~Depot Placebo Naltrexone Implant"
10839611|NCT00218426|OG001|Outcome|DNI + ONP , Naltrexone Implant + Oral Naltrexone Placebo|"naltrexone implant~naltrexone implant: The implant is 1000 mg naltrexone~ONP oral naltrexone placebo tablet"
10839612|NCT00218426|OG002|Outcome|ONP + DNIP, Oral Placebo Naltrexone and Depot Placebo Implant|"ONP daily placebo oral naltrexone~monthly placebo depot naltrexone implant"
10839613|NCT00218426|OG000|Outcome|ONP + DNI|"Oral naltrexone placebo (ONP) + Depot Naltrexone Implant (DNI) 1000 mg~naltrexone implant: naltrexone implant is 1000 mg naltrexone~oral placebo naltrexone: oral placebo naltrexone resembles active medication"
10839614|NCT00218426|OG001|Outcome|ON + DNIP|"Oral naltrexone (ON) 50 mg + Depot Naltrexone placebo Implant (DNIP)~oral naltrexone: oral naltrexone 50 mg/day~placebo implant: placebo implant resembles active medication"
10839615|NCT00218426|OG002|Outcome|ONP + DNIP|"Oral placebo naltrexone + placebo naltrexone implant~oral placebo naltrexone: oral placebo naltrexone resembles active medication~placebo implant: placebo implant resembles active medication"
10839616|NCT00218426|EG000|Reported Event|ON + DNIP, Oral Naltrexone + Depot Placebo Naltrexone Implant|"Oral naltrexone~Oral naltrexone: oral naltrexone 50 mg/day~DNIP~Depot Placebo Naltrexone Implant"
10839617|NCT00218426|EG001|Reported Event|DNI + ONP , Naltrexone Implant + Oral Naltrexone Placebo|"naltrexone implant~naltrexone implant: The implant is 1000 mg naltrexone~ONP oral naltrexone placebo tablet"
10839618|NCT00218426|EG002|Reported Event|ONP + DNIP, Oral Placebo Naltrexone and Depot Placebo Implant|"ONP daily placebo oral naltrexone~monthly placebo depot naltrexone implant"
10839619|NCT00218439|BG000|Baseline|Placebo First 4 Weeks, Then Paroxetine for 4 Weeks|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
10839620|NCT00218439|BG001|Baseline|Paroxetine First 4 Weeks, Then Placebo for 4 Weeks|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
10839621|NCT00218439|BG002|Baseline|Total|Total of all reporting groups
10839622|NCT00218439|FG000|Participant Flow|Placebo (4 Weeks) Then Paroxetine (4 Weeks)|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
10839623|NCT00218439|FG001|Participant Flow|Paroxetine (4 Weeks) the Placebo (4 Weeks)|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
10839624|NCT00218439|OG000|Outcome|After 4 Weeks of Placebo|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
10839625|NCT00218439|OG001|Outcome|After 4 Weeks of Paroxetine|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
10839626|NCT00218439|OG000|Outcome|After 4 Weeks of Placebo|Change in diastolic blood pressure fom Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
10839627|NCT00218439|OG001|Outcome|After 4 Weeks of Paroxetine|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
10839628|NCT00218439|OG000|Outcome|After 4 Weeks of Placebo|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
10839629|NCT00218439|OG001|Outcome|After 4 Weeks of Paroxetine|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
10839630|NCT00218439|OG000|Outcome|After 4 Weeks of Placebo|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
10839631|NCT00218439|OG001|Outcome|After 4 Weeks of Paroxetine|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
10839632|NCT00218439|OG000|Outcome|After 4 Weeks of Placebo|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
10839633|NCT00218439|OG001|Outcome|After 4 Weeks of Paroxetine|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
10839634|NCT00218439|EG000|Reported Event|During 4 Weeks of Placebo|Participants receive placebo daily for 4 weeks
10839635|NCT00218439|EG001|Reported Event|During 4 Weeks of Paroxetine|Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
10839636|NCT00218465|BG000|Baseline|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
10839637|NCT00218465|BG001|Baseline|Placebo|Placebo group for 5 week relapse prevention trial.
10839638|NCT00218465|BG002|Baseline|Total|Total of all reporting groups
10839639|NCT00218465|FG000|Participant Flow|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
10839640|NCT00218465|FG001|Participant Flow|Placebo|Placebo group for 5 week relapse prevention trial.
10839641|NCT00218465|OG000|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
10839642|NCT00218465|OG001|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
10839643|NCT00218465|EG000|Reported Event|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
10839644|NCT00218465|EG001|Reported Event|Placebo|Placebo group for 5 week relapse prevention trial.
10839645|NCT00218491|BG000|Baseline|1200mg N-Acetylcysteine|"1200mg N-Acetylcysteine~N-Acetylcysteine: 1200mg N-Acetylcysteine"
10839646|NCT00218491|BG001|Baseline|2400mg N-Acetylcysteine|"2400mg N-Acetylcysteine~N-Acetylcysteine: 2400mg N-Acetylcysteine"
10839647|NCT00218491|BG002|Baseline|Matching Placebo|"Matching Placebo~Matching Placebo: Matching Placebo"
10839648|NCT00218491|BG003|Baseline|Total|Total of all reporting groups
10839649|NCT00218491|FG000|Participant Flow|1200mg N-Acetylcysteine|"1200mg N-Acetylcysteine~N-Acetylcysteine: 1200mg N-Acetylcysteine"
10839650|NCT00218491|FG001|Participant Flow|2400mg N-Acetylcysteine|"2400mg N-Acetylcysteine~N-Acetylcysteine: 2400mg N-Acetylcysteine"
10839651|NCT00218491|FG002|Participant Flow|Matching Placebo|Matching Placebo: Matching Placebo
10839652|NCT00218491|OG000|Outcome|1200mg N-Acetylcysteine|"1200mg N-Acetylcysteine~N-Acetylcysteine: 1200mg N-Acetylcysteine"
10839653|NCT00218491|OG001|Outcome|2400mg N-Acetylcysteine|"2400mg N-Acetylcysteine~N-Acetylcysteine: 2400mg N-Acetylcysteine"
10839654|NCT00218491|OG002|Outcome|Matching Placebo|Matching Placebo: Matching Placebo
10839655|NCT00218491|EG000|Reported Event|1200mg N-Acetylcysteine|"1200mg N-Acetylcysteine~N-Acetylcysteine: 1200mg N-Acetylcysteine"
10839656|NCT00218491|EG001|Reported Event|2400mg N-Acetylcysteine|"2400mg N-Acetylcysteine~N-Acetylcysteine: 2400mg N-Acetylcysteine"
10839657|NCT00218491|EG002|Reported Event|Matching Placebo|Matching Placebo: Matching Placebo
10839658|NCT00218543|BG000|Baseline|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
10839659|NCT00218543|FG000|Participant Flow|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
10839660|NCT00218543|OG000|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
10839661|NCT00218543|EG000|Reported Event|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
10839662|NCT00218634|BG000|Baseline|CBT-AD|Cognitive behavioral therapy for adherence and depression
10839663|NCT00218634|BG001|Baseline|ETAU|Enhanced Treatment as Usual
10839664|NCT00218634|BG002|Baseline|Total|Total of all reporting groups
10839665|NCT00218634|FG000|Participant Flow|CBT-AD|Cognitive behavioral therapy for adherence and depression
10839666|NCT00218634|FG001|Participant Flow|ETAU|Enhanced Treatment as Usual
10839667|NCT00218634|OG000|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
10839668|NCT00218634|OG001|Outcome|ETAU|Enhanced treatment as usual
10839669|NCT00218634|OG000|Outcome|Cognitive Behavioral Therapy for Adherence and Depression|Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).
10839670|NCT00218634|OG001|Outcome|Enhanced Treatment as Usual|Enhanced treatment as usual (ETAU).
10839671|NCT00218634|OG001|Outcome|ETAU|Enhanced Treatment as Usual
10839672|NCT00218634|EG000|Reported Event|CBT-AD|Cognitive behavioral therapy for adherence and depression
10839673|NCT00218634|EG001|Reported Event|ETAU|Enhanced Treatment as Usual
10839674|NCT00219141|BG000|Baseline|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
10839675|NCT00219141|BG001|Baseline|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
10839676|NCT00219141|BG002|Baseline|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
10839677|NCT00219141|BG003|Baseline|Total|Total of all reporting groups
10839678|NCT00219141|FG000|Participant Flow|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
10839679|NCT00219141|FG001|Participant Flow|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
10839680|NCT00219141|FG002|Participant Flow|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
10839681|NCT00219141|OG000|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
10839682|NCT00219141|OG001|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
10839683|NCT00219141|OG002|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
10839684|NCT00219141|EG000|Reported Event|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
10839685|NCT00219141|EG001|Reported Event|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
10839686|NCT00219141|EG002|Reported Event|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
10839687|NCT00219284|BG000|Baseline|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839688|NCT00219284|BG001|Baseline|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839689|NCT00219284|BG002|Baseline|Total|Total of all reporting groups
10839690|NCT00219284|FG000|Participant Flow|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839691|NCT00219284|FG001|Participant Flow|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839692|NCT00219284|OG000|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839693|NCT00219284|OG001|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839694|NCT00219284|EG000|Reported Event|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839695|NCT00219284|EG001|Reported Event|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
10839696|NCT00219349|BG000|Baseline|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
10839697|NCT00219349|FG000|Participant Flow|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
10839698|NCT00219349|OG000|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
10839699|NCT00219349|EG000|Reported Event|Group 1|all subject entered
10848190|NCT00289094|OG000|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10848191|NCT00289094|OG001|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10839700|NCT00219544|BG000|Baseline|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
10839701|NCT00219544|FG000|Participant Flow|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
10839702|NCT00219544|FG001|Participant Flow|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
10839703|NCT00219544|OG000|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
10839704|NCT00219544|OG001|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
10839705|NCT00219544|OG000|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
10839706|NCT00219544|EG000|Reported Event|Pregabalin Single-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
10839707|NCT00219544|EG001|Reported Event|Pregabalin Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatent phase.
10839708|NCT00219544|EG002|Reported Event|Placebo Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
10839709|NCT00219557|BG000|Baseline|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839710|NCT00219557|BG001|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839711|NCT00219557|BG002|Baseline|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839712|NCT00219557|BG003|Baseline|Total|Total of all reporting groups
10839713|NCT00219557|FG000|Participant Flow|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839714|NCT00219557|FG001|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839715|NCT00219557|FG002|Participant Flow|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839716|NCT00219557|OG000|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839717|NCT00219557|OG001|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839718|NCT00219557|OG000|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839719|NCT00219557|OG000|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839720|NCT00219557|EG000|Reported Event|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839721|NCT00219557|EG001|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle.
10839722|NCT00219557|EG002|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
10839723|NCT00220636|BG000|Baseline|Aripiprazole|aripiprazole augmentation treatment
10839724|NCT00220636|FG000|Participant Flow|Aripiprazole|aripiprazole augmentation treatment
10839725|NCT00220636|OG000|Outcome|Aripiprazole|aripiprazole augmentation treatment
10839726|NCT00220636|OG000|Outcome|Aripiprazole|aripiprazole augmentation treatment for treatment resistant depression
10839727|NCT00220636|EG000|Reported Event|Aripiprazole|aripiprazole augmentation treatment
10839728|NCT00220701|BG000|Baseline|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839729|NCT00220701|BG001|Baseline|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839730|NCT00220701|BG002|Baseline|Total|Total of all reporting groups
10839731|NCT00220701|FG000|Participant Flow|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839732|NCT00220701|FG001|Participant Flow|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839733|NCT00220701|OG000|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839734|NCT00220701|OG001|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839735|NCT00220701|EG000|Reported Event|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839736|NCT00220701|EG001|Reported Event|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
10839737|NCT00220727|BG000|Baseline|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
10839738|NCT00220727|BG001|Baseline|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
10839739|NCT00220727|BG002|Baseline|Total|Total of all reporting groups
10839740|NCT00220727|FG000|Participant Flow|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
10839741|NCT00220727|FG001|Participant Flow|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
10839742|NCT00220727|OG000|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
10839743|NCT00220727|OG001|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
10839744|NCT00220727|OG000|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
10839745|NCT00220727|OG001|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
10839746|NCT00220727|EG000|Reported Event|IGIV-C, 10% - 0.08 mL/kg/Min|IGIV-C (0.08 mL/kg/min);
10839747|NCT00220727|EG001|Reported Event|IGIV-C, 10% - 0.14 mL/kg/Min|IGIV-C (0.14 mL/kg/min);
10839748|NCT00220740|BG000|Baseline|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
10839749|NCT00220740|BG001|Baseline|Placebo|.1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose
10839750|NCT00220740|BG002|Baseline|Total|Total of all reporting groups
10839751|NCT00220740|FG000|Participant Flow|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
10839752|NCT00220740|FG001|Participant Flow|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
10839753|NCT00220740|OG000|Outcome|IGIV-C|
10839754|NCT00220740|OG001|Outcome|Placebo|
10839755|NCT00220740|OG000|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
10839756|NCT00220740|OG001|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
10839757|NCT00220740|EG000|Reported Event|IGIV-C|"2 g/kg loading dose, followed by 1 g/kg maintenance dose.~A total of 113 subjects were exposed to IGIV-C across all three treatments/periods."
10839758|NCT00220740|EG001|Reported Event|Placebo|".1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.~A total of 95 subjects were exposed to Placebo across all three treatments/periods."
10839759|NCT00220779|BG000|Baseline|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
10839760|NCT00220779|BG001|Baseline|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
10839761|NCT00220779|BG002|Baseline|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
10839762|NCT00220779|BG003|Baseline|Total|Total of all reporting groups
10839763|NCT00220779|FG000|Participant Flow|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
10839764|NCT00220779|FG001|Participant Flow|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
10839765|NCT00220779|FG002|Participant Flow|Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion|Immune globulin (intravenous) (IGIV)
10839766|NCT00220779|OG000|Outcome|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
10839767|NCT00220779|OG001|Outcome|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
10839768|NCT00220779|OG002|Outcome|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
10839769|NCT00220779|EG000|Reported Event|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
10839770|NCT00220779|EG001|Reported Event|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
10839771|NCT00220779|EG002|Reported Event|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
10839772|NCT00220805|BG000|Baseline|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
10839773|NCT00220805|BG001|Baseline|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
10839774|NCT00220805|BG002|Baseline|Total|Total of all reporting groups
10839775|NCT00220805|FG000|Participant Flow|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
10839776|NCT00220805|FG001|Participant Flow|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
10839777|NCT00220805|OG000|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
10839778|NCT00220805|OG001|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
10839779|NCT00220805|EG000|Reported Event|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
10839780|NCT00220805|EG001|Reported Event|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
10839781|NCT00220961|BG000|Baseline|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
10839782|NCT00220961|BG001|Baseline|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
10839783|NCT00220961|BG002|Baseline|Total|Total of all reporting groups
10839784|NCT00220961|FG000|Participant Flow|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day"
10839785|NCT00220961|FG001|Participant Flow|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets - 45mg/day tablet"
10839786|NCT00220961|OG000|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
10839787|NCT00220961|OG001|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
10839788|NCT00220961|EG000|Reported Event|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
10839789|NCT00220961|EG001|Reported Event|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
10839790|NCT00221104|BG000|Baseline|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
10839791|NCT00221104|BG001|Baseline|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
10839792|NCT00221104|BG002|Baseline|Total|Total of all reporting groups
10839793|NCT00221104|FG000|Participant Flow|Pravastatin Group|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
10839794|NCT00221104|FG001|Participant Flow|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
10839795|NCT00221104|OG000|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
10839796|NCT00221104|OG001|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
10839797|NCT00221104|OG000|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
10839798|NCT00221104|OG001|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
10839799|NCT00221104|EG000|Reported Event|Pravastatin Group|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
10839800|NCT00221104|EG001|Reported Event|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
10839801|NCT00221117|BG000|Baseline|Conventional Occupational Therapy-Control Group|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
10839802|NCT00221117|BG001|Baseline|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
10839803|NCT00221117|BG002|Baseline|Total|Total of all reporting groups
10839804|NCT00221117|FG000|Participant Flow|Conventional Occupational Therapy-Control Group|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
10839805|NCT00221117|FG001|Participant Flow|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
10839806|NCT00221117|OG000|Outcome|FES Therapy|The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
10839807|NCT00221117|OG001|Outcome|Conventional Occupational Therapy|The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
10839808|NCT00221117|OG000|Outcome|FES Group|
10839809|NCT00221117|OG001|Outcome|Conventional Occupational Therapy|
10839810|NCT00221117|EG000|Reported Event|Control Group|Conventional Occupational Therapy
10839811|NCT00221117|EG001|Reported Event|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
10839812|NCT00221195|BG000|Baseline|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
10839813|NCT00221195|BG001|Baseline|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
10839814|NCT00221195|BG002|Baseline|Total|Total of all reporting groups
10839815|NCT00221195|FG000|Participant Flow|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
10839816|NCT00221195|FG001|Participant Flow|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
10839817|NCT00221195|OG000|Outcome|Bleeds During the On-demand Period|"During the on-demand period, bleeding was treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.~Final analysis only included those who completed per protocol, only 26 subjects completed the study."
10839818|NCT00221195|OG001|Outcome|Bleeds During the Prophylaxis Period|"During the prophylaxis period, AICC was administered at a target dose of 85 U per kilogram (±15%) (range, 72 to 98) on 3 nonconsecutive days weekly. Bleeding episodes during the prophylaxis period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.~Final analysis only included those who completed per protocol, only 26 subjects completed the study."
10839819|NCT00221195|EG000|Reported Event|On-demand Period|"During the on-demand period, bleeding was treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.~There were 3 subjects that never received on-demand therapy, therefore 31 subjects were assessed for AEs during this period."
10839820|NCT00221195|EG001|Reported Event|Prophylaxis Period|"During the prophylaxis period, AICC was administered at a target dose of 85 U per kilogram (±15%) (range, 72 to 98) on 3 nonconsecutive days weekly. Bleeding episodes during the prophylaxis period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.~There were 3 subjects that never received prophylaxis therapy, therefore 31 subjects were assessed for AEs during this period."
10839821|NCT00221195|EG002|Reported Event|Washout Period|"Bleeding episodes during the washout period were treated with AICC at a target dose of 85 U per kilogram of body weight (±15%) (range, 72 to 98). For bleeding episodes that did not respond to the specified therapy, alternative treatment, including additional doses of AICC, rFVIIa, or factor VIII, was allowed at the discretion of the treating physician.~There were 5 subjects that never entered the washout period, therefore 31 subjects were assessed for AEs during this period."
10839822|NCT00221299|BG000|Baseline|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839823|NCT00221299|BG001|Baseline|Parathyroid Hormone Injections and Risedronate Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839824|NCT00221299|BG002|Baseline|Parathyroid Hormone Placebo Injections and Risedronate Tables|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
10839825|NCT00221299|BG003|Baseline|Total|Total of all reporting groups
10839826|NCT00221299|FG000|Participant Flow|Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839827|NCT00221299|FG001|Participant Flow|Group1b-rhPTH&RisendronatePlacebo|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839828|NCT00221299|FG002|Participant Flow|Group2-rhPTH&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839829|NCT00221299|FG003|Participant Flow|Group3-rhPTH-Placebo&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839830|NCT00221299|OG000|Outcome|Parathyroid Hormone&Risedronate Placebo|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839831|NCT00221299|OG001|Outcome|Parathyroid Hormone&Risedronate|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839832|NCT00221299|OG002|Outcome|Parathyroid Hormone Placebo&Risedronate|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
10839833|NCT00221299|EG000|Reported Event|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839834|NCT00221299|EG001|Reported Event|Parthyroid Hormone Injections and Risedronte Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
10839835|NCT00221299|EG002|Reported Event|Parathyroid Hormone Placebo Injections and Risedronate Tablets|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
10839836|NCT00221338|BG000|Baseline|Gabapentin|"Double blind, placebo controlled~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839837|NCT00221338|BG001|Baseline|Placebo|"Double blind~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839838|NCT00221338|BG002|Baseline|Total|Total of all reporting groups
10839839|NCT00221338|FG000|Participant Flow|Gabapentin|"Double blind, placebo controlled~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839840|NCT00221338|FG001|Participant Flow|Placebo|"Double blind~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839841|NCT00221338|OG000|Outcome|Gabapentin|"Double blind, placebo controlled~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839842|NCT00221338|OG001|Outcome|Placebo|"Double blind~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839843|NCT00221338|EG000|Reported Event|Gabapentin|"Double blind, placebo controlled~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839844|NCT00221338|EG001|Reported Event|Placebo|"Double blind~Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days"
10839845|NCT00221403|BG000|Baseline|Risperidone|Subjects taking Risperidone only.
10839846|NCT00221403|BG001|Baseline|Valproate|Subjects taking Valproate only.
10839847|NCT00221403|BG002|Baseline|Placebo|Subjects taking Placebo only.
10839848|NCT00221403|BG003|Baseline|Total|Total of all reporting groups
10839849|NCT00221403|FG000|Participant Flow|Risperidone|Subjects only taking Risperidone.
10839850|NCT00221403|FG001|Participant Flow|Valproate|Subjects taking Valproate only.
10839851|NCT00221403|FG002|Participant Flow|Placebo|Subjects taking Placebo only.
10848572|NCT00290498|BG001|Baseline|R-CHOP|R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
10839852|NCT00221403|OG000|Outcome|Valproate (VPA)|"VPA was administered in liquid form, matched for taste and color with the placebo. Medication was administered in a double-blinded manner on a twice-daily basis. Patients randomized to VPA were administered an initial dose of 10 mg/kg/day on a twice daily schedule beginning on day 0. VPA levels were adjusted to achieve a blood level of 80-100 lg/mL. An independent, unblinded study psychiatrist adjusted VPA doses to achieve a therapeutic level~Valproate Oral Solution: liquid, BID dosing."
10839853|NCT00221403|OG001|Outcome|Risperidone|"Risperidone was administered in liquid form matched for taste and color to the placebo. Medications were administered in a double-blinded manner on a twice-daily basis.~Risperidone oral solution: liquid, BID dosing."
10839854|NCT00221403|OG002|Outcome|Placebo|"The placebo was administered in liquid form, matched for taste and color with the active comparator.~Placebo: liquid, BID dosing."
10839855|NCT00221403|EG000|Reported Event|Risperidone|Subjects only taking Risperidone.
10839856|NCT00221403|EG001|Reported Event|Valproate|Subjects taking Valproate only.
10839857|NCT00221403|EG002|Reported Event|Placebo|Subjects taking Placebo only.
10839858|NCT00222105|BG000|Baseline|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
10839859|NCT00222105|FG000|Participant Flow|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
10839860|NCT00222105|OG000|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
10839861|NCT00222105|EG000|Reported Event|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
10839862|NCT00222131|BG000|Baseline|Esomeprazole|Esomeprazole 40 mg QD
10839863|NCT00222131|BG001|Baseline|Placebo|Matching placebo
10839864|NCT00222131|BG002|Baseline|Total|Total of all reporting groups
10839865|NCT00222131|FG000|Participant Flow|Esomeprazole|Esomeprazole 40 mg one time a day (QD)
10839866|NCT00222131|FG001|Participant Flow|Placebo|Matching placebo
10839867|NCT00222131|OG000|Outcome|Esomeprazole|Esomeprazole 40 mg QD
10839868|NCT00222131|OG001|Outcome|Placebo|Matching placebo
10839869|NCT00222131|EG000|Reported Event|Esomeprazole|Esomeprazole 40 mg QD
10839870|NCT00222131|EG001|Reported Event|Placebo|Matching placebo
10839871|NCT00222729|BG000|Baseline|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
10839872|NCT00222729|FG000|Participant Flow|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
10839873|NCT00222729|OG000|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
10839874|NCT00222729|EG000|Reported Event|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
10839875|NCT00223080|BG000|Baseline|Vaccine|"ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.~ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL"
10839876|NCT00223080|BG001|Baseline|Placebo|"ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.~ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection"
10839877|NCT00223080|BG002|Baseline|Total|Total of all reporting groups
10839878|NCT00223080|FG000|Participant Flow|Vaccine|"ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.~ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL"
10839879|NCT00223080|FG001|Participant Flow|Placebo|"ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.~ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection"
10839880|NCT00223080|OG000|Outcome|Vaccine|"ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.~ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL"
10839881|NCT00223080|OG001|Outcome|Placebo|"ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.~ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection"
10839882|NCT00223080|EG000|Reported Event|Vaccine|"ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.~ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL"
10839883|NCT00223080|EG001|Reported Event|Placebo|"ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.~ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection"
10839884|NCT00223236|BG000|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10839885|NCT00223236|BG001|Baseline|Placebo|Inactive ingredient matching the active medication in appearance
10839886|NCT00223236|BG002|Baseline|Total|Total of all reporting groups
10839887|NCT00223236|FG000|Participant Flow|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10839888|NCT00223236|FG001|Participant Flow|Placebo|Inactive ingredient matching the active medication in appearance
10848573|NCT00290498|BG002|Baseline|Total|Total of all reporting groups
10839889|NCT00223236|OG000|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10839890|NCT00223236|OG001|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
10839891|NCT00223236|EG000|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
10839892|NCT00223236|EG001|Reported Event|Placebo|Inactive ingredient matching the active medication in appearance
10839893|NCT00223262|BG000|Baseline|Lamotrigine|Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
10839894|NCT00223262|BG001|Baseline|Placebo|Matched placebo identical in appearance to the active drug.
10839895|NCT00223262|BG002|Baseline|Total|Total of all reporting groups
10839896|NCT00223262|FG000|Participant Flow|Lamotrigine|Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
10839897|NCT00223262|FG001|Participant Flow|Placebo|Matched placebo identical in appearance to the active drug.
10839898|NCT00223262|OG000|Outcome|Lamotrigine|Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
10839899|NCT00223262|OG001|Outcome|Placebo|Matched placebo identical in appearance to the active drug.
10839900|NCT00223262|EG000|Reported Event|Lamotrigine|Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
10839901|NCT00223262|EG001|Reported Event|Placebo|Matched placebo identical in appearance to the active drug.
10839902|NCT00223496|BG000|Baseline|Aripiprazole|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
10839903|NCT00223496|FG000|Participant Flow|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
10839904|NCT00223496|OG000|Outcome|Aripiprazole Plus Divalalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
10839905|NCT00223496|EG000|Reported Event|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
10839906|NCT00223652|BG000|Baseline|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
10839907|NCT00223652|BG001|Baseline|Treatment as Usual|Treatment as usual control.
10839908|NCT00223652|BG002|Baseline|Total|Total of all reporting groups
10839909|NCT00223652|FG000|Participant Flow|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
10839910|NCT00223652|FG001|Participant Flow|Treatment as Usual|Treatment as usual control.
10839911|NCT00223652|OG000|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
10839912|NCT00223652|OG001|Outcome|Treatment as Usual|Treatment as usual control.
10839913|NCT00223652|OG000|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
10839914|NCT00223652|EG000|Reported Event|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
10839915|NCT00223652|EG001|Reported Event|Treatment as Usual|Treatment as usual control.
10839916|NCT00223665|BG000|Baseline|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
10839917|NCT00223665|FG000|Participant Flow|Intermittent Androgen Suppression (IAS)|"Intermittent Androgen Suppression in 9 month cycles:~Flutamide, 250 mg by mouth 3 times daily for a total of two weeks~Leuprolide Acetate, 7.5mg intramuscular injections every 4 weeks for a total of nine months"
10839918|NCT00223665|OG000|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
10839919|NCT00223665|OG000|Outcome|Combined Androgen Blockade|"Intermittent Hormone Therapy using Flutamide and Leuprolide acetate~Flutamide: 250mg three times a day by mouth~Leuprolide Acetate: 7.5mg once a month by intramuscular injection"
10839920|NCT00223665|EG000|Reported Event|Combined Androgen Blockade|"Intermittent Hormone Therapy using Flutamide and Leuprolide acetate~Flutamide: 250mg three times a day by mouth~Leuprolide Acetate: 7.5mg once a month by intramuscular injection"
10839921|NCT00223678|BG000|Baseline|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
10839922|NCT00223678|BG001|Baseline|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
10839923|NCT00223678|BG002|Baseline|Total|Total of all reporting groups
10839924|NCT00223678|FG000|Participant Flow|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
10839925|NCT00223678|FG001|Participant Flow|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
10839926|NCT00223678|OG000|Outcome|Rapamycin Group|pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin.Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
10839927|NCT00223678|OG001|Outcome|CNI Group|Patient will remain on calcineurin inhibitor with a low target serum levels 50ng/ml to 125ng/mg 12 hour trough
10839928|NCT00223678|EG000|Reported Event|Rapamycin Group|
10839929|NCT00223678|EG001|Reported Event|CNI Group|
10839930|NCT00223704|BG000|Baseline|Placebo Group|Placebo was normal saline
10839931|NCT00223704|BG001|Baseline|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
10839932|NCT00223704|BG002|Baseline|HOE 140 Group|Bradykinin B2 receptor antagonist
10839933|NCT00223704|BG003|Baseline|Total|Total of all reporting groups
10839934|NCT00223704|FG000|Participant Flow|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
10839935|NCT00223704|FG001|Participant Flow|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
10839936|NCT00223704|FG002|Participant Flow|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
10839937|NCT00223704|OG000|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
10839938|NCT00223704|OG001|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
10839939|NCT00223704|OG002|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
10839940|NCT00223704|EG000|Reported Event|Placebo Group|Placebo was normal saline
10839941|NCT00223704|EG001|Reported Event|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
10839942|NCT00223704|EG002|Reported Event|HOE 140 Group|Bradykinin B2 receptor antagonist
10839943|NCT00223795|BG000|Baseline|Baseline Characteristics All Subjects|Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
10839944|NCT00223795|FG000|Participant Flow|Arm 1 - Control/Crossover|No cane first, then single point cane
10839945|NCT00223795|FG001|Participant Flow|Arm 2 - Cane|Single point cane first, then continue with single point cane
10839946|NCT00223795|OG000|Outcome|Arm 1 - Waiting Control|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
10848192|NCT00289094|EG000|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10839947|NCT00223795|OG001|Outcome|Arm 2- Cane Users|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
10839948|NCT00223795|EG000|Reported Event|Arm 1: Intervention - no Cane for First 8 Weeks|No cane for first 8 weeks
10839949|NCT00223795|EG001|Reported Event|Arm 1 - Intervention - Crossover to Cane|Given single point cane to use for 4 months following 8 weeks without a cane
10839950|NCT00223795|EG002|Reported Event|Arm 2- Single Point Cane|single point cane for 8 weeks then single point cane for next 4 months
10839951|NCT00223808|BG000|Baseline|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
10839952|NCT00223808|BG001|Baseline|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
10839953|NCT00223808|BG002|Baseline|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
10839954|NCT00223808|BG003|Baseline|Total|Total of all reporting groups
10839955|NCT00223808|FG000|Participant Flow|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
10839956|NCT00223808|FG001|Participant Flow|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
10839957|NCT00223808|FG002|Participant Flow|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
10839958|NCT00223808|OG000|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
10839959|NCT00223808|OG001|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
10839960|NCT00223808|OG002|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
10839961|NCT00223808|EG000|Reported Event|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
10839962|NCT00223808|EG001|Reported Event|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
10839963|NCT00223808|EG002|Reported Event|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
10839964|NCT00223821|BG000|Baseline|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
10839965|NCT00223821|BG001|Baseline|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
10839966|NCT00223821|BG002|Baseline|Total|Total of all reporting groups
10839967|NCT00223821|FG000|Participant Flow|Drug Therapy Alone|"drug therapy alone~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects."
10839968|NCT00223821|FG001|Participant Flow|Drug Therapy + Behavioral Training|"drug therapy + behavioral training~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.~Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
10839969|NCT00223821|OG000|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
10839970|NCT00223821|OG001|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
10839971|NCT00223821|EG000|Reported Event|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
10839972|NCT00223821|EG001|Reported Event|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
10839973|NCT00223977|BG000|Baseline|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
10839974|NCT00223977|BG001|Baseline|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
10839975|NCT00223977|BG002|Baseline|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
10839976|NCT00223977|BG003|Baseline|Total|Total of all reporting groups
10839977|NCT00223977|FG000|Participant Flow|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
10839978|NCT00223977|FG001|Participant Flow|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
10839979|NCT00223977|FG002|Participant Flow|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
10839980|NCT00223977|OG000|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
10839981|NCT00223977|OG001|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
10839982|NCT00223977|OG002|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
10839983|NCT00223977|EG000|Reported Event|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
10839984|NCT00223977|EG001|Reported Event|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
10839985|NCT00223977|EG002|Reported Event|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
10839986|NCT00223990|BG000|Baseline|FMP1/AS02A|"FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~FMP1/AS02A: FMP1/AS02A candidate malaria vaccine"
10839987|NCT00223990|BG001|Baseline|RabAvert (Rabies Vaccine)|"RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~RabAvert: RabAvert rabies vaccine"
10839988|NCT00223990|BG002|Baseline|Total|Total of all reporting groups
10839989|NCT00223990|FG000|Participant Flow|FMP1/AS02A|"FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~FMP1/AS02A: FMP1/AS02A candidate malaria vaccine"
10839990|NCT00223990|FG001|Participant Flow|RabAvert (Rabies Vaccine)|"RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~RabAvert: RabAvert rabies vaccine"
10839991|NCT00223990|OG000|Outcome|FMP1/AS02A|"FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~FMP1/AS02A: FMP1/AS02A candidate malaria vaccine"
10839992|NCT00223990|OG001|Outcome|RabAvert (Rabies Vaccine)|"RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~RabAvert: RabAvert rabies vaccine"
10839993|NCT00223990|EG000|Reported Event|FMP1/AS02A|"FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~FMP1/AS02A: FMP1/AS02A candidate malaria vaccine"
10839994|NCT00223990|EG001|Reported Event|RabAvert (Rabies Vaccine)|"RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months~RabAvert: RabAvert rabies vaccine"
10839995|NCT00224016|BG000|Baseline|Oxybutynin TDS|Oxybutynin Transdermal System
10839996|NCT00224016|BG001|Baseline|Oral Oxybutynin|Oxybutynin tablets
10839997|NCT00224016|BG002|Baseline|Total|Total of all reporting groups
10839998|NCT00224016|FG000|Participant Flow|Oxybutynin TDS|Oxybutynin Transdermal System
10839999|NCT00224016|FG001|Participant Flow|Oral Oxybutynin|Oxybutynin tablets
10840000|NCT00224016|OG000|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
10840001|NCT00224016|OG001|Outcome|Oral Oxybutynin|Oxybutynin tablets
10840002|NCT00224016|EG000|Reported Event|Oxybutynin TDS|Oxybutynin Transdermal System
10840003|NCT00224016|EG001|Reported Event|Oral Oxybutynin|Oxybutynin tablets
10840004|NCT00224029|BG000|Baseline|Oxybutynin Transdermal System|
10840005|NCT00224029|FG000|Participant Flow|Oxybutynin Transdermal System|
10840006|NCT00224029|OG000|Outcome|Oxybutynin Transdermal System|
10840007|NCT00224029|EG000|Reported Event|Oxybutynin Transdermal System|
10840008|NCT00224042|BG000|Baseline|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
10840009|NCT00224042|BG001|Baseline|Oral Iron|
10840010|NCT00224042|BG002|Baseline|Total|Total of all reporting groups
10840011|NCT00224042|FG000|Participant Flow|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
10840012|NCT00224042|FG001|Participant Flow|Oral Iron|
10840013|NCT00224042|OG000|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
10840014|NCT00224042|OG001|Outcome|Oral Iron|
10840015|NCT00224042|EG000|Reported Event|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
10840016|NCT00224042|EG001|Reported Event|Oral Iron|
10840017|NCT00224055|BG000|Baseline|IV Iron|
10840018|NCT00224055|BG001|Baseline|Oral Iron|
10840019|NCT00224055|BG002|Baseline|Total|Total of all reporting groups
10840020|NCT00224055|FG000|Participant Flow|IV Iron|
10840021|NCT00224055|FG001|Participant Flow|Oral Iron|
10840022|NCT00224055|OG000|Outcome|IV Iron|
10840023|NCT00224055|OG001|Outcome|Oral Iron|
10840024|NCT00224055|EG000|Reported Event|IV Iron|
10840025|NCT00224055|EG001|Reported Event|Oral Iron|
10840026|NCT00224107|BG000|Baseline|Silodosin|Silodosin 8 mg once daily with food
10840027|NCT00224107|BG001|Baseline|Placebo|Matching placebo capsule once daily with food
10840028|NCT00224107|BG002|Baseline|Total|Total of all reporting groups
10840029|NCT00224107|FG000|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
10840030|NCT00224107|FG001|Participant Flow|Placebo|Matching placebo capsule once daily with food
10840031|NCT00224107|OG000|Outcome|Silodosin|Silodosin 8 mg once daily with food
10840032|NCT00224107|OG001|Outcome|Placebo|Matching placebo capsule once daily with food
10840033|NCT00224107|EG000|Reported Event|Silodosin|Silodosin 8 mg once daily with food
10840034|NCT00224107|EG001|Reported Event|Placebo|Matching placebo capsule once daily with food
10840035|NCT00224120|BG000|Baseline|Silodosin|Silodosin 8 mg once daily with food
10840036|NCT00224120|BG001|Baseline|Placebo|Matching placebo capsule once daily with food
10840037|NCT00224120|BG002|Baseline|Total|Total of all reporting groups
10840038|NCT00224120|FG000|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
10840039|NCT00224120|FG001|Participant Flow|Placebo|Matching placebo capsule once daily with food
10840040|NCT00224120|OG000|Outcome|Silodosin|Silodosin 8 mg once daily with food
10840041|NCT00224120|OG001|Outcome|Placebo|Matching placebo capsule once daily with food
10840042|NCT00224120|EG000|Reported Event|Silodosin|Silodosin 8 mg once daily with food
10840043|NCT00224120|EG001|Reported Event|Placebo|Matching placebo capsule once daily with food
10840044|NCT00224133|BG000|Baseline|8 mg Silodosin Per Day With Food|
10840045|NCT00224133|FG000|Participant Flow|8 mg Silodosin Per Day With Food|
10840046|NCT00224133|OG000|Outcome|8 mg Silodosin Per Day With Food|
10840047|NCT00224133|EG000|Reported Event|8 mg Silodosin Per Day With Food|
10840048|NCT00224289|BG000|Baseline|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
10840049|NCT00224289|FG000|Participant Flow|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
10840050|NCT00224289|OG000|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
10840051|NCT00224289|EG000|Reported Event|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
10840052|NCT00224484|BG000|Baseline|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840053|NCT00224484|BG001|Baseline|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840054|NCT00224484|BG002|Baseline|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840055|NCT00224484|BG003|Baseline|Total|Total of all reporting groups
10840056|NCT00224484|FG000|Participant Flow|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840057|NCT00224484|FG001|Participant Flow|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840058|NCT00224484|FG002|Participant Flow|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840059|NCT00224484|OG000|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840060|NCT00224484|OG001|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840061|NCT00224484|OG002|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840062|NCT00224484|OG001|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
10840063|NCT00224484|EG000|Reported Event|Group GD2-AS04|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840064|NCT00224484|EG001|Reported Event|Group Havrix|Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840065|NCT00224484|EG002|Reported Event|Group Saline|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840066|NCT00224484|EG003|Reported Event|GD2-AS04 (ESFU) Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
10840067|NCT00224484|EG004|Reported Event|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
10840068|NCT00224770|BG000|Baseline|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
10840069|NCT00224770|BG001|Baseline|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
10840070|NCT00224770|BG002|Baseline|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
10840071|NCT00224770|BG003|Baseline|Total|Total of all reporting groups
10840072|NCT00224770|FG000|Participant Flow|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
10840073|NCT00224770|FG001|Participant Flow|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
10840074|NCT00224770|FG002|Participant Flow|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
10840075|NCT00224770|OG000|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
10848193|NCT00289094|EG001|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10848194|NCT00289107|BG000|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
11220388|NCT02333630|BG000|Baseline|AsthmaCare Intervention|"Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.~AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management"
11220389|NCT02333630|BG001|Baseline|Control Group|"Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.~Asthma education: A website with links to written asthma education and videos"
11220390|NCT02333630|BG002|Baseline|Total|Total of all reporting groups
11220391|NCT02333630|FG000|Participant Flow|AsthmaCare Intervention|"Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.~AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management"
11220392|NCT02333630|FG001|Participant Flow|Control Group|"Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.~Asthma education: A website with links to written asthma education and videos"
11220393|NCT02333630|OG000|Outcome|AsthmaCare Intervention|"Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.~AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management"
11220394|NCT02333630|OG001|Outcome|Control Group|"Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.~Asthma education: A website with links to written asthma education and videos"
11220395|NCT02333630|OG000|Outcome|AsthmaCare|Participants randomized to AsthmaCare intervention
11220396|NCT02333630|OG001|Outcome|Control|Participants randomized to control group
11220397|NCT02333630|OG000|Outcome|AsthmaCare|Data were not collected for this measure
11220398|NCT02333630|OG001|Outcome|Control|Data were not collected for this measure
11220399|NCT02333630|EG000|Reported Event|AsthmaCare Intervention|"Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.~AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management"
11220400|NCT02333630|EG001|Reported Event|Control Group|"Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.~Asthma education: A website with links to written asthma education and videos"
11220401|NCT02334059|BG000|Baseline|Ketamine|"Ketamine: 0.5 mg/kg IV dose~Ketamine: Ketamine infusion plus placebo infusion of normal saline~Placebo: 2 placebo infusions"
11220402|NCT02334059|BG001|Baseline|Ketamine Plus Magnesium|"Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV~Ketamine plus magnesium: Ketamine plus magnesium infusion"
11220403|NCT02334059|BG002|Baseline|Placebo|"Placebo (normal saline)~Placebo: 2 placebo infusions"
11220404|NCT02334059|BG003|Baseline|Total|Total of all reporting groups
11220405|NCT02334059|FG000|Participant Flow|Ketamine|"Ketamine: 0.5 mg/kg IV dose~Ketamine: Ketamine infusion plus placebo infusion of normal saline~Placebo: 2 placebo infusions"
11220406|NCT02334059|FG001|Participant Flow|Ketamine Plus Magnesium|"Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV~Ketamine plus magnesium: Ketamine plus magnesium infusion"
11220407|NCT02334059|FG002|Participant Flow|Placebo|"Placebo (normal saline)~Placebo: 2 placebo infusions"
11220408|NCT02334059|OG000|Outcome|Ketamine|"Ketamine: 0.5 mg/kg IV dose~Ketamine: Ketamine infusion plus placebo infusion of normal saline~Placebo: 2 placebo infusions"
11220409|NCT02334059|OG001|Outcome|Ketamine Plus Magnesium|"Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV~Ketamine plus magnesium: Ketamine plus magnesium infusion"
11220410|NCT02334059|OG002|Outcome|Placebo|"Placebo (normal saline)~Placebo: 2 placebo infusions"
11220411|NCT02334059|EG000|Reported Event|Ketamine|"Ketamine: 0.5 mg/kg IV dose~Ketamine: Ketamine infusion plus placebo infusion of normal saline~Placebo: 2 placebo infusions"
11220412|NCT02334059|EG001|Reported Event|Ketamine Plus Magnesium|"Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV~Ketamine plus magnesium: Ketamine plus magnesium infusion"
11220413|NCT02334059|EG002|Reported Event|Placebo|"Placebo (normal saline)~Placebo: 2 placebo infusions"
11220414|NCT02334215|BG000|Baseline|Methadone Plus Patient Navigation|"Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.~Patient Navigation: A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community."
11220415|NCT02334215|BG001|Baseline|Methadone|"Participants will begin methadone during detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community."
11220416|NCT02334215|BG002|Baseline|Enhanced Treatment as Usual|"Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community.~Enhanced Treatment as Usual (ETAU): Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community."
11220417|NCT02334215|BG003|Baseline|Total|Total of all reporting groups
11328595|NCT03430245|BG000|Baseline|VelaShape III & UltraShape Power|"Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.~The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.~The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action."
11220418|NCT02334215|FG000|Participant Flow|Methadone Plus Patient Navigation|"Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.~Patient Navigation: A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community."
11220419|NCT02334215|FG001|Participant Flow|Methadone|"Participants will begin methadone during detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community."
11220420|NCT02334215|FG002|Participant Flow|Enhanced Treatment as Usual|"Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community.~Enhanced Treatment as Usual (ETAU): Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community."
11220421|NCT02334215|OG000|Outcome|Methadone Plus Patient Navigation|"Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.~Patient Navigation: A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community."
11220422|NCT02334215|OG001|Outcome|Methadone|"Participants will begin methadone during detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community."
11220423|NCT02334215|OG002|Outcome|Enhanced Treatment as Usual|"Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community.~Enhanced Treatment as Usual (ETAU): Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community."
11220424|NCT02334215|EG000|Reported Event|Methadone Plus Patient Navigation|"Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.~Patient Navigation: A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community."
11220425|NCT02334215|EG001|Reported Event|Methadone|"Participants will begin methadone during detention.~Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community."
11220426|NCT02334215|EG002|Reported Event|Enhanced Treatment as Usual|"Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community.~Enhanced Treatment as Usual (ETAU): Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community."
11220427|NCT02334267|BG000|Baseline|Group 1Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
11220428|NCT02334267|BG001|Baseline|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
11220429|NCT02334267|BG002|Baseline|Total|Total of all reporting groups
11220430|NCT02334267|FG000|Participant Flow|Group 1 Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
11328596|NCT03430245|FG000|Participant Flow|VelaShape III & UltraShape Power|"Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.~The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.~The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action."
10840076|NCT00224770|OG001|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
10840077|NCT00224770|OG002|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
10840078|NCT00224770|OG002|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
10840079|NCT00224770|EG000|Reported Event|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
10840080|NCT00224770|EG001|Reported Event|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
10840081|NCT00224770|EG002|Reported Event|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
10842932|NCT00250588|OG001|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
10842933|NCT00250588|OG002|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
10842934|NCT00250588|EG000|Reported Event|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
10842935|NCT00250588|EG001|Reported Event|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
10842936|NCT00250588|EG002|Reported Event|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
10842937|NCT00250679|BG000|Baseline|Formoterol 12 Mcg 2x/Day|
10842938|NCT00250679|BG001|Baseline|Arformoterol 15 Mcg 2x/Day|
10842939|NCT00250679|BG002|Baseline|Arformoterol 25 Mcg 2x/Day|
10842940|NCT00250679|BG003|Baseline|Total|Total of all reporting groups
10842941|NCT00250679|FG000|Participant Flow|Formoterol 12 Mcg 2x/Day|
10842942|NCT00250679|FG001|Participant Flow|Arformoterol 15 Mcg 2x/Day|
10842943|NCT00250679|FG002|Participant Flow|Arformoterol 25 Mcg 2x/Day|
10842944|NCT00250679|OG000|Outcome|Formoterol 12 Mcg 2x/Day|
10842945|NCT00250679|OG001|Outcome|Arformoterol 15 Mcg 2x/Day|
10842946|NCT00250679|OG002|Outcome|Arformoterol 25 Mcg 2x/Day|
10842947|NCT00250679|EG000|Reported Event|Formoterol 12 Mcg 2x/Day|
10842948|NCT00250679|EG001|Reported Event|Arformoterol 15 Mcg 2x/Day|
10842949|NCT00250679|EG002|Reported Event|Arformoterol 25 Mcg 2x/Day|
10842950|NCT00250705|BG000|Baseline|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
11220431|NCT02334267|FG001|Participant Flow|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
11220432|NCT02334267|OG000|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
11220433|NCT02334267|OG001|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
11220434|NCT02334267|OG000|Outcome|GranuFlo|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
11220435|NCT02334267|OG001|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
11220436|NCT02334267|OG000|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
11220437|NCT02334267|OG001|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
11220438|NCT02334267|OG000|Outcome|GranuFlo|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
11220439|NCT02334267|OG001|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
11220440|NCT02334267|EG000|Reported Event|GranuFlo|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo.
11220441|NCT02334267|EG001|Reported Event|NaturaLyte|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte.
11220442|NCT02334306|BG000|Baseline|Placebo/MEDI5872 210 mg|Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants received MEDI5872 QW from Days 99 to 113 and Q2W from Days 127 to 183.
11220443|NCT02334306|BG001|Baseline|MEDI5872 210 mg/MEDI5872 210 mg|Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants continued dosing of MEDI5872 210mg Q2W from Days 99 to 183 and received an additional dose of blinded placebo on Day 106.
11220444|NCT02334306|BG002|Baseline|Total|Total of all reporting groups
11220445|NCT02334306|FG000|Participant Flow|Placebo/MEDI5872 210 mg|Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants received MEDI5872 QW from Days 99 to 113 and Q2W from Days 127 to 183.
11220446|NCT02334306|FG001|Participant Flow|MEDI5872 210 mg/MEDI5872 210 mg|Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants continued dosing of MEDI5872 210mg Q2W from Days 99 to 183 and received an additional dose of blinded placebo on Day 106.
11220447|NCT02334306|OG000|Outcome|Placebo|Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
11220448|NCT02334306|OG001|Outcome|MEDI5872 210 mg|Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
11220449|NCT02334306|OG001|Outcome|Any MEDI5872 210 mg|"Participants received at least one dose of MEDI5872 treatment either during double-blind and/or open-label period of the study.~In double-bind period, participants received a fixed SC dose of 210 mg MEDI5872 QW for 3 weeks (Days 1, 8, and 15) and then every Q2W for 9 weeks (Days 29 to 85).~In open-label period, participants who received MEDI5872 210mg in double-blinded period received MEDI5872 210mg on Days 99 and Day 113; and participants who received placebo in double-blinded period received MEDI5872 210mg QW from Days 99 to 113, later all participants received MEDI5872 210mg Q2W from Days 127 to 183 and were followed up till Day 296."
11220450|NCT02334306|EG000|Reported Event|Placebo|Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
11328597|NCT03430245|OG000|Outcome|VelaShape III & UltraShape Power|Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
11328598|NCT03430245|EG000|Reported Event|VelaShape III & UltraShape Power|Subjects left and right thighs were each treated with both VelaShape III and UltraShape Power, a combined treatment.
11220451|NCT02334306|EG001|Reported Event|Any MEDI5872 210 mg|"Participants received at least one dose of MEDI5872 treatment either during double-blind and/or open-label period of the study.~In double-bind period, participants received a fixed SC dose of 210 mg MEDI5872 QW for 3 weeks (Days 1, 8, and 15) and then every Q2W for 9 weeks (Days 29 to 85).~In open-label period, participants who received MEDI5872 210mg in double-blinded period received MEDI5872 210mg on Days 99 and Day 113; and participants who received placebo in double-blinded period received MEDI5872 210mg QW from Days 99 to 113, later all participants received MEDI5872 210mg Q2W from Days 127 to 183 and were followed up till Day 296."
11220452|NCT02334358|BG000|Baseline|YVOIRE Classic s|"Treatment with YVOIRE Classic s~YVOIRE Classic s"
11220453|NCT02334358|FG000|Participant Flow|YVOIRE Classic s|YVOIRE Classic s
11220454|NCT02334358|OG000|Outcome|YVOIRE Classic s|"Treatment with YVOIRE Classic s~YVOIRE Classic s"
11220455|NCT02334358|EG000|Reported Event|YVOIRE Classic s|"Treatment with YVOIRE Classic s~YVOIRE Classic s"
11220456|NCT02334384|BG000|Baseline|Antimicrobial TheraGauze|"Antimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220457|NCT02334384|BG001|Baseline|Standard Wound Packing|"Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220458|NCT02334384|BG002|Baseline|Total|Total of all reporting groups
11220459|NCT02334384|FG000|Participant Flow|Antimicrobial TheraGauze|"Antimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220460|NCT02334384|FG001|Participant Flow|Standard Wound Packing|"Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220461|NCT02334384|OG000|Outcome|Antimicrobial TheraGauze|"Antimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220462|NCT02334384|OG001|Outcome|Standard Wound Packing|"Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220463|NCT02334384|EG000|Reported Event|Antimicrobial TheraGauze|"Antimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220464|NCT02334384|EG001|Reported Event|Standard Wound Packing|"Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.~Antimicrobial TheraGauze: In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
11220465|NCT02334423|BG000|Baseline|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220466|NCT02334423|BG001|Baseline|Placebo|"0.9 % sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo"
11220467|NCT02334423|BG002|Baseline|Total|Total of all reporting groups
11220468|NCT02334423|FG000|Participant Flow|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220469|NCT02334423|FG001|Participant Flow|Placebo|"0.9 % sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo"
11220470|NCT02334423|OG000|Outcome|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220471|NCT02334423|OG001|Outcome|Placebo|"0.9 % sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo"
10840082|NCT00224874|BG000|Baseline|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
10840083|NCT00224874|BG001|Baseline|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
10840084|NCT00224874|BG002|Baseline|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
10840085|NCT00224874|BG003|Baseline|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
10840086|NCT00224874|BG004|Baseline|Total|Total of all reporting groups
10840087|NCT00224874|FG000|Participant Flow|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
10840088|NCT00224874|FG001|Participant Flow|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
10840089|NCT00224874|FG002|Participant Flow|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
10840090|NCT00224874|FG003|Participant Flow|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
11220472|NCT02334423|EG000|Reported Event|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220473|NCT02334423|EG001|Reported Event|Placebo|"0.9 % sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo"
11220474|NCT02334436|BG000|Baseline|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220475|NCT02334436|BG001|Baseline|Placebo|"0.9% sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo Comparator Arm"
11220476|NCT02334436|BG002|Baseline|Total|Total of all reporting groups
11220477|NCT02334436|FG000|Participant Flow|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220478|NCT02334436|FG001|Participant Flow|Placebo|"0.9% sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo Comparator Arm"
11220479|NCT02334436|OG000|Outcome|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220480|NCT02334436|OG001|Outcome|Placebo|"0.9% sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo Comparator Arm"
11220481|NCT02334436|EG000|Reported Event|Botulinum Toxin, Type A|"Botulinum toxin, Type A~Botulinum toxin, Type A: Botulinum toxin, Type A"
11220482|NCT02334436|EG001|Reported Event|Placebo|"0.9% sterile, unpreserved saline~0.9% sterile, unpreserved saline: Placebo Comparator Arm"
11220483|NCT02334527|BG000|Baseline|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220484|NCT02334527|FG000|Participant Flow|Palbociclib (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220485|NCT02334527|OG000|Outcome|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220486|NCT02334527|OG000|Outcome|Palbociclib Single Arm Trial|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220487|NCT02334527|OG000|Outcome|Palbociclib (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220488|NCT02334527|OG000|Outcome|Any Grade Adverse Events|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220489|NCT02334527|OG001|Outcome|Grade >=3 Adverse Event|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off"
11220490|NCT02334527|EG000|Reported Event|Single Arm (Single Arm Trial)|"Palbociclib~Palbociclib: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off."
11220491|NCT02334683|BG000|Baseline|Electrophysiologic Guidance Then Ultrasound Guidance|"Electrophysiologic guidance, using electrical stimulation~Electrical stimulation: The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves.~Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.~Ultrasound: The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves."
11220492|NCT02334683|BG001|Baseline|Ultrasound Guidance Then Electrophysiologic Guidance|"Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.~Ultrasound: The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves.~Electrophysiologic guidance, using electrical stimulation~Electrical stimulation: The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves."
11220493|NCT02334683|BG002|Baseline|Total|Total of all reporting groups
11220494|NCT02334683|FG000|Participant Flow|Electrophysiologic Guidance Then Ultrasound Guidance|"Electrophysiologic guidance, using electrical stimulation to locate the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle.~Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles."
11220495|NCT02334683|FG001|Participant Flow|Ultrasound Guidance Then Electrophysiologic Guidance|"Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.~Electrophysiologic guidance, using electrical stimulation to locate the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle."
11220496|NCT02334683|OG000|Outcome|Electrophysiologic Guidance|Electrical stimulation: the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by electrical stimulation using a needle .
11220497|NCT02334683|OG001|Outcome|Ultrasound Guidance|Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
11220498|NCT02334683|EG000|Reported Event|Electrophysiologic Guidance|Electrical stimulation: the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by electrical stimulation using a needle .
11220499|NCT02334683|EG001|Reported Event|Ultrasound Guidance|Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
11220500|NCT02334748|BG000|Baseline|Canakinumab|Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment.
11220501|NCT02334748|FG000|Participant Flow|Canakinumab|Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose was 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigator's judgment.
11220502|NCT02334748|OG000|Outcome|Canakinumab|Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
11220503|NCT02334748|EG000|Reported Event|Canakinumab (ACZ885)|Patients continued the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
11220504|NCT02334787|BG000|Baseline|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
11220505|NCT02334787|BG001|Baseline|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
11220506|NCT02334787|BG002|Baseline|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
11220507|NCT02334787|BG003|Baseline|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
11220508|NCT02334787|BG004|Baseline|Total|Total of all reporting groups
11220509|NCT02334787|FG000|Participant Flow|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
11220510|NCT02334787|FG001|Participant Flow|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
11220511|NCT02334787|FG002|Participant Flow|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
11220512|NCT02334787|FG003|Participant Flow|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
11220513|NCT02334787|OG000|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
11220514|NCT02334787|OG001|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
11220515|NCT02334787|OG002|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
11220516|NCT02334787|OG000|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220517|NCT02334787|OG001|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220518|NCT02334787|OG002|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220519|NCT02334787|EG000|Reported Event|0.3 % OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment
11220520|NCT02334787|EG001|Reported Event|1% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
11220521|NCT02334787|EG002|Reported Event|3% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
11220522|NCT02334787|EG003|Reported Event|Placebo in a Single Adminstaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment.
11220523|NCT02334787|EG004|Reported Event|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220524|NCT02334787|EG005|Reported Event|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220525|NCT02334787|EG006|Reported Event|3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
11220526|NCT02334787|EG007|Reported Event|Placebo Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
11220527|NCT02334800|BG000|Baseline|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220528|NCT02334800|BG001|Baseline|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220529|NCT02334800|BG002|Baseline|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220530|NCT02334800|BG003|Baseline|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220531|NCT02334800|BG004|Baseline|Total|Total of all reporting groups
11220532|NCT02334800|FG000|Participant Flow|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220533|NCT02334800|FG001|Participant Flow|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220534|NCT02334800|FG002|Participant Flow|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220535|NCT02334800|FG003|Participant Flow|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220536|NCT02334800|OG000|Outcome|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220537|NCT02334800|OG001|Outcome|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220538|NCT02334800|OG002|Outcome|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220539|NCT02334800|OG003|Outcome|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220540|NCT02334800|EG000|Reported Event|Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)|Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220541|NCT02334800|EG001|Reported Event|Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220542|NCT02334800|EG002|Reported Event|Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11220543|NCT02334800|EG003|Reported Event|Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)|Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
11328599|NCT03430349|BG000|Baseline|Novel OPV2 Candidate 1|Participants received one vaccination with novel OPV2 candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ 50% cell culture infectious dose units [CCID50]).
11328600|NCT03430349|BG001|Baseline|Novel OPV2 Candidate 2|Participants received one vaccination with novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11328601|NCT03430349|BG002|Baseline|Total|Total of all reporting groups
11328602|NCT03430349|FG000|Participant Flow|Novel OPV2 Candidate 1|Participants received one vaccination with novel OPV2 candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ 50% cell culture infectious dose units [CCID50]).
11328603|NCT03430349|FG001|Participant Flow|Novel OPV2 Candidate 2|Participants received one vaccination with novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11328604|NCT03430349|OG000|Outcome|Novel OPV2 Candidate 1|Participants received one vaccination with novel OPV2 candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11328605|NCT03430349|OG001|Outcome|Novel OPV2 Candidate 2|Participants received one vaccination with novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11328606|NCT03430349|OG000|Outcome|Novel OPV2 Candidate 1|Participants received one vaccination with novel OPV2 candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ 50% cell culture infectious dose units [CCID50]).
11328607|NCT03430349|EG000|Reported Event|Novel OPV2 Candidate 1|Participants received one vaccination with novel OPV2 candidate 1 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
10840091|NCT00224874|OG000|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
11328608|NCT03430349|EG001|Reported Event|Novel OPV2 Candidate 2|Participants received one vaccination with novel OPV2 candidate 2 on study Day 0, administered orally as six drops (0.3 mL total; approximately 10⁶ CCID50).
11328609|NCT03430856|BG000|Baseline|Insulin Tregopil (IN-105) - 45mg|At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328610|NCT03430856|BG001|Baseline|Insulin Tregopil (IN-105) - 30mg|At randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328611|NCT03430856|BG002|Baseline|Insulin Aspart|At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328612|NCT03430856|BG003|Baseline|Total|Total of all reporting groups
11328613|NCT03430856|FG000|Participant Flow|Insulin Tregopil (IN-105) - 45mg|At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328614|NCT03430856|FG001|Participant Flow|Insulin Tregopil (IN-105) - 30mg|SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328615|NCT03430856|FG002|Participant Flow|Insulin Aspart|At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
11328616|NCT03430856|OG000|Outcome|Insulin Tregopil (IN-105) - 45mg|"Strength of each tablet is 15mg~Insulin Tregopil: Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit."
11328617|NCT03430856|OG001|Outcome|Insulin Tregopil (IN-105) - 30mg|"Strength of each tablet is 15mg~Insulin Tregopil: Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit."
11328618|NCT03430856|OG002|Outcome|Insulin Aspart|"Pre-filled pen: 100 U/L~Insulin Aspart: Drug: Insulin Aspart Mode of Administration: To be administered within 5 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit"
11328619|NCT03430856|OG000|Outcome|Insulin Tregopil (IN-105) - 45mg|At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328620|NCT03430856|OG001|Outcome|Insulin Tregopil (IN-105) - 30mg|SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328621|NCT03430856|OG002|Outcome|Insulin Aspart|At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
11328622|NCT03430856|EG000|Reported Event|Insulin Tregopil (IN-105) - 45mg|At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328623|NCT03430856|EG001|Reported Event|Insulin Tregopil (IN-105) - 30mg|SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.
11328624|NCT03430856|EG002|Reported Event|Insulin Aspart|At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
11328625|NCT03430986|BG000|Baseline|No-treatment Control|Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
11328626|NCT03430986|BG001|Baseline|JUVÉDERM® VOLUMA® With Lidocaine|Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
11328627|NCT03430986|BG002|Baseline|Total|Total of all reporting groups
11328628|NCT03430986|FG000|Participant Flow|No-treatment Control|Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
11328629|NCT03430986|FG001|Participant Flow|JUVÉDERM® VOLUMA® With Lidocaine|Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
11328630|NCT03430986|OG000|Outcome|No-treatment Control|Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
11328631|NCT03430986|OG001|Outcome|JUVÉDERM® VOLUMA® With Lidocaine|Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
11328632|NCT03430986|OG000|Outcome|JUVÉDERM® VOLUMA® With Lidocaine|Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
11328633|NCT03430986|EG000|Reported Event|No-treatment Control (Control Period)|Participants who received no treatment during the 24-week Control Period.
11328634|NCT03430986|EG001|Reported Event|JUVÉDERM® VOLUMA® With Lidocaine (Control Period)|Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel to the nose area during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
11328635|NCT03430986|EG002|Reported Event|VOLUMA Initially Treated (Post-Control Period)|Participants in the 24-week Post-Control Period who were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period.
11328636|NCT03430986|EG003|Reported Event|VOLUMA Optionally Treated (Post-Control Period)|Participants in the 24-week Post-Control Period who received no treatment in the 24-week Control Period then were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with an optional treatment 8 weeks later, if applicable
11328637|NCT03431012|BG000|Baseline|Virus Agency/Negative Attribute Framing|"Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
10840092|NCT00224874|OG001|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
11328638|NCT03431012|BG001|Baseline|Human Agency/Negative Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328639|NCT03431012|BG002|Baseline|Human Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328640|NCT03431012|BG003|Baseline|Virus Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328641|NCT03431012|BG004|Baseline|Total|Total of all reporting groups
11328642|NCT03431012|FG000|Participant Flow|Virus Agency/Negative Attribute Framing|"Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328643|NCT03431012|FG001|Participant Flow|Human Agency/Negative Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328644|NCT03431012|FG002|Participant Flow|Human Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328645|NCT03431012|FG003|Participant Flow|Virus Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
10840093|NCT00224874|OG002|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
11328646|NCT03431012|OG000|Outcome|Virus Agency/Negative Attribute Framing|"Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328647|NCT03431012|OG001|Outcome|Human Agency/Negative Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328648|NCT03431012|OG002|Outcome|Human Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328649|NCT03431012|OG003|Outcome|Virus Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328650|NCT03431012|OG000|Outcome|Human Agency|Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (HA: 'You can contract the virus when you touch…')
11328651|NCT03431012|OG001|Outcome|Virus Agency|Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (VA: 'It can infect you when you touch…')
11328652|NCT03431012|OG000|Outcome|Negative Framing|Participants in this condition, after reading a hypothetical scenario, received health messages describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).
11328653|NCT03431012|OG001|Outcome|Positive Framing|Participants in this condition, after reading a hypothetical scenario, received health messages describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).
11328654|NCT03431012|EG000|Reported Event|Virus Agency/Negative Attribute Framing|"Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328655|NCT03431012|EG001|Reported Event|Human Agency/Negative Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328656|NCT03431012|EG002|Reported Event|Human Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328657|NCT03431012|EG003|Reported Event|Virus Agency /Positive Attribute Framing|"Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).~Agency Assignment framing: Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')~Attribute framing: Each message described the side effects of the antivirals in terms of chances of either experiencing or not side effects"
11328658|NCT03431337|BG000|Baseline|High Dose|Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days
11328659|NCT03431337|BG001|Baseline|Standard Dose|Amoxicillin 875 mg/clavulanate 125 mg + placebo
11328660|NCT03431337|BG002|Baseline|Total|Total of all reporting groups
11328661|NCT03431337|FG000|Participant Flow|High Dose|"Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days~Amoxicillin 875 mg: Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125"
11328662|NCT03431337|FG001|Participant Flow|Standard Dose|"Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days.~Placebo (lactase): Placebo (in place of additional amoxicillin in experimental arm)"
11328663|NCT03431337|OG000|Outcome|High Dose|Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days
11328664|NCT03431337|OG001|Outcome|Standard Dose|Amoxicillin 875 mg/clavulanate 125 mg + placebo
11328665|NCT03431337|OG000|Outcome|Prone to Diarrhea|Answering yes to baseline question of whether prone to diarrhea
11328666|NCT03431337|OG001|Outcome|Not Prone to Diarrhea|Answering no to baseline question of whether prone to diarrhea
11328667|NCT03431337|OG000|Outcome|Prone to Vaginal Itching or Discharge|Female participants indicating proneness to vaginal itching or discharge at enrollment
11328668|NCT03431337|OG001|Outcome|Not Prone to Vaginal Itching or Discharge|Female participants indicating no proneness to vaginal itching or discharge at enrollment
11328669|NCT03431337|EG000|Reported Event|High Dose|Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days
11328670|NCT03431337|EG001|Reported Event|Standard Dose|Amoxicillin 875 mg/clavulanate 125 mg + placebo
11328671|NCT03431441|BG000|Baseline|Test|Subject that wore the etafilcon A lenses throughout the entire duration of the study.
11328672|NCT03431441|FG000|Participant Flow|Test|Subject that wore the etafilcon A lenses throughout the entire duration of the study.
11328673|NCT03431441|OG000|Outcome|Test|Subject that wore the etafilcon A lenses throughout the entire duration of the study.
11328674|NCT03431441|EG000|Reported Event|Test|Subject that wore the etafilcon A lenses throughout the entire duration of the study.
11328675|NCT03431857|BG000|Baseline|TESS V2 Prosthesis|Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
11328676|NCT03431857|FG000|Participant Flow|TESS V2 Prosthesis|Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
11328677|NCT03431857|OG000|Outcome|TESS V2 Prosthesis|Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
11328678|NCT03431857|EG000|Reported Event|TESS V2 Prosthesis|Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
11328679|NCT03432390|BG000|Baseline|CPAP|Continuous Positive Airway Pressure: A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
11328680|NCT03432390|BG001|Baseline|Control: Open System Ventilation|Open system ventilation: Facemask ventilation adapted to the anesthesia work station
11328681|NCT03432390|BG002|Baseline|Total|Total of all reporting groups
11328682|NCT03432390|FG000|Participant Flow|CPAP|Continuous Positive Airway Pressure: A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
11328683|NCT03432390|FG001|Participant Flow|Control: Open System Ventilation|Open system ventilation: Facemask ventilation adapted to the anesthesia work station
11328684|NCT03432390|OG000|Outcome|CPAP|Continuous Positive Airway Pressure: A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
11328685|NCT03432390|OG001|Outcome|Controle|Open system ventilation: Facemask ventilation adapted to the anesthesia work station
11328686|NCT03432390|EG000|Reported Event|CPAP|Continuous Positive Airway Pressure: A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
11328687|NCT03432390|EG001|Reported Event|Control: Open System Ventilation|Open system ventilation: Facemask ventilation adapted to the anesthesia work station
11328688|NCT03432533|BG000|Baseline|Romosozumab 210 mg QM: PFS|During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
11328689|NCT03432533|BG001|Baseline|Romosozumab 210 mg QM: AI/Pen|During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
10840094|NCT00224874|OG003|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
10840095|NCT00224874|EG000|Reported Event|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
10840096|NCT00224874|EG001|Reported Event|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
10840097|NCT00224874|EG002|Reported Event|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
10840098|NCT00224874|EG003|Reported Event|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
10840099|NCT00224887|BG000|Baseline|in Home Nutrition Counseling|"In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors~In home nutrition counseling: In home family-based behavioral counseling"
10840100|NCT00224887|BG001|Baseline|Standard Nutrition Education Curriculum|"standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid~standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid"
10840101|NCT00224887|BG002|Baseline|Total|Total of all reporting groups
10840102|NCT00224887|FG000|Participant Flow|in Home Nutrition Counseling|"In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors~In home nutrition counseling: In home family-based behavioral counseling"
10840103|NCT00224887|FG001|Participant Flow|Standard Nutrition Education Curriculum|"standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid~standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid"
10840104|NCT00224887|OG000|Outcome|in Home Nutrition Counseling|"In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors~In home nutrition counseling: In home family-based behavioral counseling"
10840105|NCT00224887|OG001|Outcome|Standard Nutrition Education Curriculum|"standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid~standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid"
10840106|NCT00224887|EG000|Reported Event|in Home Nutrition Counseling|"In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors~In home nutrition counseling: In home family-based behavioral counseling"
10840107|NCT00224887|EG001|Reported Event|Standard Nutrition Education Curriculum|"standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid~standard nutrition education curriculum: video and lesson plans based on USDA Food Guide Pyramid"
10840108|NCT00224952|BG000|Baseline|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840109|NCT00224952|BG001|Baseline|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840110|NCT00224952|BG002|Baseline|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
10840111|NCT00224952|BG003|Baseline|Total|Total of all reporting groups
10840112|NCT00224952|FG000|Participant Flow|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840113|NCT00224952|FG001|Participant Flow|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840114|NCT00224952|FG002|Participant Flow|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
10840115|NCT00224952|OG000|Outcome|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
11328690|NCT03432533|BG002|Baseline|Total|Total of all reporting groups
10840116|NCT00224952|OG001|Outcome|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840117|NCT00224952|OG002|Outcome|Valproic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
10840118|NCT00224952|OG002|Outcome|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
10840119|NCT00224952|EG000|Reported Event|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840120|NCT00224952|EG001|Reported Event|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
10840121|NCT00224952|EG002|Reported Event|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
10840122|NCT00225017|BG000|Baseline|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
10840123|NCT00225017|BG001|Baseline|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
10840124|NCT00225017|BG002|Baseline|Total|Total of all reporting groups
10840125|NCT00225017|FG000|Participant Flow|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
10840126|NCT00225017|FG001|Participant Flow|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
10840127|NCT00225017|OG000|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
10840128|NCT00225017|OG001|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
10840129|NCT00225017|EG000|Reported Event|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
10840130|NCT00225017|EG001|Reported Event|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
10840131|NCT00225147|BG000|Baseline|"100 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included all subjects who received 100 IU/kg rhC1INH."
10840132|NCT00225147|BG001|Baseline|"50 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included subjects who received 50 IU/kg rhC1INH. One (1) subject was randomized to the 50 IU/kg rhC1INH arm, but did not receive study drug administration and was excluded from the mITT analysis population."
10840133|NCT00225147|BG002|Baseline|Placebo|"Baseline characteristics were calculated for the modified intention to treat (mITT) analysis population, which included all subjects randomized to the placebo arm."
10840134|NCT00225147|BG003|Baseline|"50 IU/kg Open-label rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT)analysis population, which included all subjects who received 50 IU/kg open-label rhC1INH."
10840135|NCT00225147|BG004|Baseline|Total|Total of all reporting groups
10840136|NCT00225147|FG000|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
10840137|NCT00225147|FG001|Participant Flow|"50 IU/kg rhC1INH"|Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
10840138|NCT00225147|FG002|Participant Flow|Placebo|Includes all subjects randomized and treated with Placebo in the double-blind phase
10840139|NCT00225147|FG003|Participant Flow|"50 IU/kg Open-label rhC1INH"|"Includes all subjects treated with 50 IU/kg open-label rhC1INH in the open-label phase."
10840140|NCT00225147|OG000|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
10840141|NCT00225147|OG001|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
10840142|NCT00225147|OG002|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
10840143|NCT00225147|OG003|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
10840144|NCT00225147|OG000|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg Recombinant human C1 inhibitor arm
10840145|NCT00225147|OG001|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg Recombinant human C1 inhibitor arm
10840146|NCT00225147|EG000|Reported Event|100 IU/kg rhC1INH|Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
10840147|NCT00225147|EG001|Reported Event|50 IU/kg rhC1INH|Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
10840148|NCT00225147|EG002|Reported Event|Placebo|Includes all subjects receiving Saline solution
10840149|NCT00225147|EG003|Reported Event|"50 IU/kg Open-label rhC1INH"|"Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg rhC1INH within 4 hours after initial administration."
10840150|NCT00225212|BG000|Baseline|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
10840151|NCT00225212|FG000|Participant Flow|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
10840152|NCT00225212|OG000|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
10840153|NCT00225212|EG000|Reported Event|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
10840154|NCT00225251|BG000|Baseline|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
10840155|NCT00225251|BG001|Baseline|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
10840156|NCT00225251|BG002|Baseline|Total|Total of all reporting groups
10840157|NCT00225251|FG000|Participant Flow|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
10840158|NCT00225251|FG001|Participant Flow|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
10840159|NCT00225251|OG000|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
10840160|NCT00225251|OG001|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
10840161|NCT00225251|EG000|Reported Event|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
10840162|NCT00225251|EG001|Reported Event|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
10840163|NCT00225277|BG000|Baseline|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
10840164|NCT00225277|BG001|Baseline|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
10840165|NCT00225277|BG002|Baseline|Total|Total of all reporting groups
10840166|NCT00225277|FG000|Participant Flow|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
10840167|NCT00225277|FG001|Participant Flow|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
10840168|NCT00225277|OG000|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
10840169|NCT00225277|OG001|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
10840170|NCT00225277|EG000|Reported Event|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
10840171|NCT00225277|EG001|Reported Event|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
10840172|NCT00225420|BG000|Baseline|Overall Study|"Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
10840173|NCT00225420|FG000|Participant Flow|Docetaxel 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments."
10840174|NCT00225420|FG001|Participant Flow|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
10840175|NCT00225420|FG002|Participant Flow|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
10840176|NCT00225420|OG000|Outcome|Docetaxel at 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
10840177|NCT00225420|OG001|Outcome|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
10840178|NCT00225420|OG002|Outcome|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
10840179|NCT00225420|OG000|Outcome|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
10840180|NCT00225420|EG000|Reported Event|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
10840181|NCT00225498|BG000|Baseline|All Participants|Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
10840182|NCT00225498|FG000|Participant Flow|Ziprasidone|ziprasidone target dose is 160 mg/day
10840183|NCT00225498|OG000|Outcome|Ziprasidone|ziprasidone target dose is 160 mg/day
10840184|NCT00225498|EG000|Reported Event|Ziprasidone|
10848195|NCT00289107|BG001|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10848196|NCT00289107|BG002|Baseline|Total|Total of all reporting groups
10848197|NCT00289107|FG000|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
11328691|NCT03432533|FG000|Participant Flow|Romosozumab 210 mg QM: PFS|During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).
11328692|NCT03432533|FG001|Participant Flow|Romosozumab 210 mg QM: AI/Pen|During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.
11328693|NCT03432533|OG000|Outcome|Romosozumab 210 mg QM: PFS|During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
11328694|NCT03432533|OG001|Outcome|Romosozumab 210 mg QM: AI/Pen|During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
11328695|NCT03432533|EG000|Reported Event|Romosozumab 210 mg SC QM by PFS|During the open-label treatment period, participants received 210 mg romosozumab SC, QM by HCP administration with PFS.
11328696|NCT03432533|EG001|Reported Event|Romosozumab 210 mg SC QM by AI/Pen|During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
11328697|NCT03432858|BG000|Baseline|Active Comparator 1|Vancomycin: 1-gram dosing
11328698|NCT03432858|BG001|Baseline|Active Comparator 2|Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
11328699|NCT03432858|BG002|Baseline|Placebo|Saline Solution: Placebo
11328700|NCT03432858|BG003|Baseline|Total|Total of all reporting groups
11328701|NCT03432858|FG000|Participant Flow|Active Comparator 1|Vancomycin: 1-gram dosing
11328702|NCT03432858|FG001|Participant Flow|Active Comparator 2|Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
11328703|NCT03432858|FG002|Participant Flow|Placebo|Saline Solution: Placebo
11328704|NCT03432858|OG000|Outcome|Active Comparator 1|Vancomycin: 1-gram dosing
11328705|NCT03432858|OG001|Outcome|Active Comparator 2|Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
11328706|NCT03432858|OG002|Outcome|Placebo|Saline Solution: Placebo
11328707|NCT03432858|EG000|Reported Event|Active Comparator 1|Vancomycin: 1-gram dosing
11328708|NCT03432858|EG001|Reported Event|Active Comparator 2|Cefazolin: 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
11328709|NCT03432858|EG002|Reported Event|Placebo|Saline Solution: Placebo
11328710|NCT03433482|BG000|Baseline|GSK3536820A ACWY_Liq24 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1
11328711|NCT03433482|BG001|Baseline|ACWY_1 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
11328712|NCT03433482|BG002|Baseline|GSK3536820A ACWY_Liq30 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
11328713|NCT03433482|BG003|Baseline|ACWY_2 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
11328714|NCT03433482|BG004|Baseline|Total|Total of all reporting groups
11328715|NCT03433482|FG000|Participant Flow|GSK3536820A ACWY_Liq24 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1
11328716|NCT03433482|FG001|Participant Flow|ACWY_1 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
11328717|NCT03433482|FG002|Participant Flow|GSK3536820A ACWY_Liq30 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
11328718|NCT03433482|FG003|Participant Flow|ACWY_2 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
11328719|NCT03433482|OG000|Outcome|GSK3536820A ACWY_Liq24 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1
11328720|NCT03433482|OG001|Outcome|ACWY_1 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
11328721|NCT03433482|OG002|Outcome|GSK3536820A ACWY_Liq30 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
11328722|NCT03433482|OG003|Outcome|ACWY_2 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
11328723|NCT03433482|EG000|Reported Event|GSK3536820A ACWY_Liq24 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1
11328724|NCT03433482|EG001|Reported Event|ACWY_1 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
11328725|NCT03433482|EG002|Reported Event|GSK3536820A ACWY_Liq30 Group|Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
11328726|NCT03433482|EG003|Reported Event|ACWY_2 Group|Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
11328727|NCT03433677|BG000|Baseline|Sequence 1 (LY900014/Insulin Lispro)|"100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks~100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods"
11328728|NCT03433677|BG001|Baseline|Sequence 2 (Insulin Lispro/LY900014)|"100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks~100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods"
11328729|NCT03433677|BG002|Baseline|Total|Total of all reporting groups
11328730|NCT03433677|FG000|Participant Flow|Sequence 1 (LY900014/Insulin Lispro)|"100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks~100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods"
11328731|NCT03433677|FG001|Participant Flow|Sequence 2 (Insulin Lispro/LY900014)|"100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks~100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods"
11328732|NCT03433677|OG000|Outcome|Insulin Lispro (Humalog®)|100 U/mL insulin lispro (Humalog®) administered by CSII
11328733|NCT03433677|OG001|Outcome|LY900014|100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII)
11328734|NCT03433677|OG000|Outcome|Insulin Lispro (Humalog®)|100 U/mL Insulin lispro (Humalog®) administered by CSII
11328735|NCT03433677|EG000|Reported Event|LY900014|LY900014 administered by continuous subcutaneous insulin infusion (CSII)
11328736|NCT03433677|EG001|Reported Event|Insulin Lispro (Humalog®)|Insulin lispro (Humalog®) administered by CSII
11328737|NCT03433703|BG000|Baseline|Lenvatinib|Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW >=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW <60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
11328738|NCT03433703|FG000|Participant Flow|Lenvatinib|Participants received lenvatinib 8 or 12 milligram (mg), capsule, orally, once daily in 28 day continuous cycles until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Body weight (BW) greater than or equal to (>=) 60 kilograms (kg) - lenvatinib 12 mg (taken as three 4 mg capsules); BW less than (<) 60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
11328739|NCT03433703|OG000|Outcome|Lenvatinib|Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW >=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW <60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
11328740|NCT03433703|EG000|Reported Event|Lenvatinib|Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW >=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW <60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).
11328741|NCT03433755|BG000|Baseline|Placebo Q2W|Placebo SC Q2W for 12 weeks
11328742|NCT03433755|BG001|Baseline|Placebo QM|Placebo SC QM for 12 weeks
11328743|NCT03433755|BG002|Baseline|Evolocumab 140 mg Q2W|Evolocumab 140 mg SC Q2W for 12 weeks
11328744|NCT03433755|BG003|Baseline|Evolocumab 420 mg QM|Evolocumab 420 mg SC QM for 12 weeks
11328745|NCT03433755|BG004|Baseline|Total|Total of all reporting groups
11328746|NCT03433755|FG000|Participant Flow|Placebo Q2W|Placebo subcutaneous (SC) Q2W for 12 weeks
11328747|NCT03433755|FG001|Participant Flow|Placebo QM|Placebo SC QM for 12 weeks
11328748|NCT03433755|FG002|Participant Flow|Evolocumab 140 mg Q2W|Evolocumab 140 mg SC Q2W for 12 weeks
11328749|NCT03433755|FG003|Participant Flow|Evolocumab 420 mg QM|Evolocumab 420 mg SC QM for 12 weeks
11328750|NCT03433755|OG000|Outcome|Placebo Q2W|Placebo SC Q2W for 12 weeks
11328751|NCT03433755|OG001|Outcome|Evolocumab 140 mg Q2W|Evolocumab 140 mg SC Q2W for 12 weeks
11328752|NCT03433755|OG002|Outcome|Placebo QM|Placebo SC QM for 12 weeks
11328753|NCT03433755|OG003|Outcome|Evolocumab 420 mg QM|Evolocumab 420 mg SC QM for 12 weeks
11328754|NCT03433755|OG001|Outcome|Placebo 420 mg SC QM|Placebo 420 mg SC QM for 12 weeks
11328755|NCT03433755|OG002|Outcome|Evolocumab 140 mg Q2W|Evolocumab 140 mg SC Q2W for 12 weeks
11328756|NCT03433755|EG000|Reported Event|Placebo Q2W|Placebo SC Q2W for 12 weeks
11328757|NCT03433755|EG001|Reported Event|Placebo QM|Placebo SC Q2W for 12 weeks
11328758|NCT03433755|EG002|Reported Event|Evolocumab 140 mg Q2W|Evolocumab 140 mg SC Q2W for 12 weeks
11328759|NCT03433755|EG003|Reported Event|Evolocumab 420 mg QM|Evolocumab 420 mg SC QM for 12 weeks
11328760|NCT03433794|BG000|Baseline|Control|"The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use."
11328761|NCT03433794|BG001|Baseline|Intervention Only|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore."
11333830|NCT03520387|FG003|Participant Flow|Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
10840185|NCT00225732|BG000|Baseline|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840186|NCT00225732|BG001|Baseline|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840187|NCT00225732|BG002|Baseline|Total|Total of all reporting groups
10840188|NCT00225732|FG000|Participant Flow|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840189|NCT00225732|FG001|Participant Flow|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840190|NCT00225732|OG000|Outcome|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840191|NCT00225732|OG001|Outcome|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840192|NCT00225732|EG000|Reported Event|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840193|NCT00225732|EG001|Reported Event|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
10840194|NCT00225758|BG000|Baseline|Endocrine Therapy Plus Lapatinib|"Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.~Lapatinib: 1500 mg po daily for 26 weeks or longer"
10840195|NCT00225758|FG000|Participant Flow|Endocrine Therapy Plus Lapatinib|"Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.~Lapatinib: 1500 mg po daily for 26 weeks or longer"
10840196|NCT00225758|OG000|Outcome|Endocrine Therapy Plus Lapatinib|"Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.~Lapatinib: 1500 mg po daily for 26 weeks or longer"
11328762|NCT03433794|BG002|Baseline|Intervention-plus-Booster|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.~Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.~Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies."
11328763|NCT03433794|BG003|Baseline|Total|Total of all reporting groups
11328764|NCT03433794|FG000|Participant Flow|Control|"The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use."
11328765|NCT03433794|FG001|Participant Flow|Intervention Only|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore."
11328766|NCT03433794|FG002|Participant Flow|Intervention-plus-Booster|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.~Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.~Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies."
11328767|NCT03433794|OG000|Outcome|Control|"The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use."
11328768|NCT03433794|OG001|Outcome|Intervention Only|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore."
11328769|NCT03433794|OG002|Outcome|Intervention-plus-Booster|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.~Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.~Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies."
11336206|NCT03563027|EG002|Reported Event|Social Incentive Gamification and Financial Incentive|"This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive~Social Incentive Gamification: Game-based intervention with points and levels~Support Sponsor: Participants select a support sponsor to receive weekly updates on progress in the game~Financial Incentive: Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met"
10840197|NCT00225758|OG000|Outcome|Lapatinib Plus Endocrine Therapy|Subjects receive lapatinib 1500 mg daily in addition to their prior endocrine therapy.
10840198|NCT00225758|OG000|Outcome|Lapatinib Plus Prior Endocrine Therapy|"Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.~Lapatinib: 1500 mg po daily for 26 weeks or longer"
10840199|NCT00225758|EG000|Reported Event|Lapatinib Plus Endocrine Therapy|Subjects receive lapatinib 1500 mg daily in addition to their prior endocrine therapy.
10840200|NCT00225784|BG000|Baseline|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
10840201|NCT00225784|FG000|Participant Flow|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
10840202|NCT00225784|OG000|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.
10840203|NCT00225784|OG000|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
10840204|NCT00225784|OG000|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR negative tumors.
10840205|NCT00225784|OG001|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
10840206|NCT00225784|EG000|Reported Event|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
10840207|NCT00226239|BG000|Baseline|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
10840208|NCT00226239|FG000|Participant Flow|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
10840209|NCT00226239|OG000|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles
10840210|NCT00226239|OG000|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
10840211|NCT00226239|EG000|Reported Event|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
10840212|NCT00226499|BG000|Baseline|MMRV Group|Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840213|NCT00226499|BG001|Baseline|OKAH Group|Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
10840214|NCT00226499|BG002|Baseline|MMR Group|Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840215|NCT00226499|BG003|Baseline|Total|Total of all reporting groups
10840216|NCT00226499|FG000|Participant Flow|MMRV Group|Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840217|NCT00226499|FG001|Participant Flow|OKAH Group|Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
10840218|NCT00226499|FG002|Participant Flow|MMR Group|Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
11336207|NCT03563183|BG000|Baseline|Overall Group|Adults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study
10840219|NCT00226499|OG000|Outcome|MMRV Group|Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840220|NCT00226499|OG001|Outcome|OKAH Group|Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
10840221|NCT00226499|OG002|Outcome|MMR Group|Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840222|NCT00226499|OG000|Outcome|OKAH Group|Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
10840223|NCT00226499|OG001|Outcome|MMR Group|Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
11328770|NCT03433794|EG000|Reported Event|Control|"The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use."
11328771|NCT03433794|EG001|Reported Event|Intervention Only|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.~Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore."
11328772|NCT03433794|EG002|Reported Event|Intervention-plus-Booster|"Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.~Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.~Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies."
11328773|NCT03434249|BG000|Baseline|Bifidobacterium BB-12®|"patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;~Bifidobacterium, BB-12® (Bifidolactis Infant)"
11328774|NCT03434249|BG001|Baseline|Placebo|"patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.~Bifidolactis Infant Placebo"
11328775|NCT03434249|BG002|Baseline|Total|Total of all reporting groups
11328776|NCT03434249|FG000|Participant Flow|Bifidobacterium BB-12®|patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days.
11328777|NCT03434249|FG001|Participant Flow|Placebo|patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
11328778|NCT03434249|OG000|Outcome|Bifidobacterium BB-12®|"patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;~Bifidobacterium, BB-12® (Bifidolactis Infant)"
11328779|NCT03434249|OG001|Outcome|Placebo|"patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.~Bifidolactis Infant Placebo"
11328780|NCT03434249|EG000|Reported Event|Bifidobacterium BB-12®|"patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;~Bifidobacterium, BB-12® (Bifidolactis Infant)"
11328781|NCT03434249|EG001|Reported Event|Placebo|"patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.~Bifidolactis Infant Placebo"
11328782|NCT03434457|BG000|Baseline|Prenatal and 3 to 72 Months|Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
11328783|NCT03434457|FG000|Participant Flow|Prenatal and 3 to 72 Months|Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
11328784|NCT03434457|OG000|Outcome|Prenatal and 3 to 72 Months|Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
11328785|NCT03434457|EG000|Reported Event|Adverse Events|all adverse events
11328786|NCT03434834|BG000|Baseline|OCT of Esophagus|All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
11328787|NCT03434834|FG000|Participant Flow|OCT of Esophagus|All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
11328788|NCT03434834|OG000|Outcome|OCT of Esophagus|All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
11328789|NCT03434834|EG000|Reported Event|OCT of Esophagus|All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations.
11328790|NCT03434977|BG000|Baseline|TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed|TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 2.
11328791|NCT03434977|BG001|Baseline|TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted|TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 2.
11328792|NCT03434977|BG002|Baseline|Total|Total of all reporting groups
11328793|NCT03434977|FG000|Participant Flow|TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed|TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 2.
11328794|NCT03434977|FG001|Participant Flow|TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted|TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 2.
11328795|NCT03434977|OG000|Outcome|TAK-536 10 mg Granules Fasted|TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11328796|NCT03434977|OG001|Outcome|TAK-536 10 mg Granules Fed|TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of either Period 1 or 2.
11328797|NCT03434977|EG000|Reported Event|TAK-536 10 mg Granules Fasted|TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11328798|NCT03434977|EG001|Reported Event|TAK-536 10 mg Granules Fed|TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of either Period 1 or 2.
11328799|NCT03435055|BG000|Baseline|Nitrous Oxide - Inhaled|Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanalgesic levels (35% inhaled concentration) over 30 minutes.
11328800|NCT03435055|FG000|Participant Flow|Nitrous Oxide - Inhaled|Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanalgesic levels (35% inhaled concentration) over 30 minutes.
11328801|NCT03435055|OG000|Outcome|Pre-Nitrous|"Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected as they receive oxygen (20 minutes) followed~Functional connectivity (Fisher's r to z transformed) between the left anterior insula and superior frontal gyrus were measured at baseline."
11328802|NCT03435055|OG001|Outcome|Nitrous Oxide - Subanesthetic Dose|"Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected as they received subanesthetic dose of nitrous oxide at (35% inhaled concentration) over 30 minutes.~Functional connectivity (z-score) between the left anterior insula and superior frontal gyrus were measured during administration of subanesthetic nitrous oxide."
11328803|NCT03435055|OG000|Outcome|Pre-Tonic Cuff|"Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected as they receive oxygen (20 minutes) at rest and during a tonic cuff stimulus applied to the leg (6 minutes).~Functional connectivity (Fisher's r to z score transformed) between the left anterior insula and the postcentral gyrus prior to (baseline) and during a tonic cuff stimulus."
11328804|NCT03435055|OG001|Outcome|Tonic Cuff Stimulus|"Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected while a tonic cuff stimulus was applied to the calf of the left leg (6 minutes).~Functional connectivity (z score) was measured between the left anterior insula and the right postcentral gyrus from the fMRI data during the tonic cuff stimulus."
11328805|NCT03435055|OG000|Outcome|Pre-nitrous|"Participants will receive a tonic (6 minutes) pressure applied to the lower leg prior to (baseline) and during administration of subanesthetic dose of nitrous oxide (35% inhaled concentration). Following each pressure stimulus, participants will rate the pain intensity of the tonic stimulus (0 = no pain, 10= worst pain imaginable, Visual Analog Scale, e.g pain intensity."
11328806|NCT03435055|OG001|Outcome|Nitrous Oxide - 35% Inhaled Concentration|"Participants will receive a tonic (6 minutes) pressure applied to the lower leg prior to (baseline) and during administration of subanesthetic dose of nitrous oxide (35% inhaled concentration). Following each pressure stimulus, participants will rate the pain intensity of the tonic stimulus (0 = no pain, 10= worst pain imaginable, Visual Analog Scale, e.g pain intensity."
11328807|NCT03435055|OG000|Outcome|Pre-Nitrous|Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected as they receive oxygen (20 minutes) followed
11328808|NCT03435055|OG001|Outcome|Nitrous Oxide - Subanesthetic Dose|Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected as they received subanesthetic dose of nitrous oxide at (35% inhaled concentration) over 30 minutes.
11328809|NCT03435055|EG000|Reported Event|Nitrous Oxide - Inhaled|"Each volunteer will participate in one scanning visit in which simultaneous fMRI/EEG data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanalgesic levels (35% inhaled concentration) over 30 minutes.~A total of 21 participants consented to participate but 2 participants did not participate in any part of the research and thus no adverse events data could have been collected."
11328810|NCT03435081|BG000|Baseline|Placebo|Placebo administered orally every day.
11328811|NCT03435081|BG001|Baseline|1 mg Baricitinib|1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328812|NCT03435081|BG002|Baseline|2 mg Baricitinib|2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328813|NCT03435081|BG003|Baseline|Total|Total of all reporting groups
11328814|NCT03435081|FG000|Participant Flow|Placebo|Placebo administered orally every day.
11328815|NCT03435081|FG001|Participant Flow|1 Milligram (mg) Baricitinib|1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
10840224|NCT00226499|EG000|Reported Event|MMRV Group|Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840225|NCT00226499|EG001|Reported Event|OKAH Group|Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
10840226|NCT00226499|EG002|Reported Event|MMR Group|Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
10840227|NCT00226577|BG000|Baseline|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
10840228|NCT00226577|FG000|Participant Flow|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
10840229|NCT00226577|OG000|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
10840230|NCT00226577|EG000|Reported Event|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
10840231|NCT00226590|BG000|Baseline|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
10840232|NCT00226590|FG000|Participant Flow|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
10840233|NCT00226590|OG000|Outcome|Induction Therapy|Tolerance of Induction Therapy prior to Chemoradiation
10840234|NCT00226590|OG000|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
10840235|NCT00226590|EG000|Reported Event|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
10840236|NCT00226655|BG000|Baseline|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
10840237|NCT00226655|FG000|Participant Flow|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
10840238|NCT00226655|OG000|Outcome|hCRF|hCRF administered 1mg bid subcutaneously
10840239|NCT00226655|EG000|Reported Event|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
10840240|NCT00226811|BG000|Baseline|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
10840241|NCT00226811|FG000|Participant Flow|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
10840242|NCT00226811|OG000|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
10840243|NCT00226811|EG000|Reported Event|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
10840244|NCT00226941|BG000|Baseline|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
10840245|NCT00226941|BG001|Baseline|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
10840246|NCT00226941|BG002|Baseline|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
10840247|NCT00226941|BG003|Baseline|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
10840248|NCT00226941|BG004|Baseline|Total|Total of all reporting groups
10840249|NCT00226941|FG000|Participant Flow|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
11328816|NCT03435081|FG002|Participant Flow|2 mg Baricitinib|2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328817|NCT03435081|OG000|Outcome|Placebo|Placebo administered orally every day.
11328818|NCT03435081|OG001|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328819|NCT03435081|OG001|Outcome|1 mg Baricitinib|1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328820|NCT03435081|OG002|Outcome|2 mg Baricitinib|2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328821|NCT03435081|EG000|Reported Event|Placebo|Placebo administered orally every day.
11328822|NCT03435081|EG001|Reported Event|1 mg Baricitinib|1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328823|NCT03435081|EG002|Reported Event|2 mg Baricitinib|2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
11328824|NCT03435211|BG000|Baseline|INVSENSOR00006|All subjects consented are enrolled into the test group and received the INVSENSOR00006.
11328825|NCT03435211|FG000|Participant Flow|INVSENSOR00006|All subjects consented are enrolled into the test group and received the INVSENSOR00006.
11328826|NCT03435211|OG000|Outcome|INVSENSOR00006|All subjects consented are enrolled into the test group and received the INVSENSOR00006.
11328827|NCT03435211|EG000|Reported Event|INVSENSOR00006|All subjects consented are enrolled into the test group and received the INVSENSOR00006.
11328828|NCT03435224|BG000|Baseline|INVSENSOR00012|All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
11328829|NCT03435224|FG000|Participant Flow|INVSENSOR00012|All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
11328830|NCT03435224|OG000|Outcome|INVSENSOR00012|All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
11328831|NCT03435224|EG000|Reported Event|INVSENSOR00012|All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
11328832|NCT03435497|BG000|Baseline|Game Changers Intervention|"Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.~Game Changers: Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks."
11328833|NCT03435497|BG001|Baseline|Control|The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
11328834|NCT03435497|BG002|Baseline|Total|Total of all reporting groups
11328835|NCT03435497|FG000|Participant Flow|Game Changers Intervention|"Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.~Game Changers: Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks."
11328836|NCT03435497|FG001|Participant Flow|Control|The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
11328837|NCT03435497|OG000|Outcome|Game Changers Intervention|"Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.~Game Changers: Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks."
11328838|NCT03435497|OG001|Outcome|Control|The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
11328839|NCT03435497|EG000|Reported Event|Game Changers Intervention|"Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.~Game Changers: Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks."
11328840|NCT03435497|EG001|Reported Event|Control|The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
11328841|NCT03435562|BG000|Baseline|Electronic Cigarette vs Own Brand Use|Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis.
11328842|NCT03435562|FG000|Participant Flow|Electronic Cigarette vs Own Brand Use|Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis.
11328843|NCT03435562|OG000|Outcome|JUUL Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (each session will be approximately 3 hours).~JUUL electronic cigarette: Effects of JUUL electronic cigarette use."
11328844|NCT03435562|OG001|Outcome|IQOS Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (each session will be approximately 3 hours).~IQOS electronic cigarette: Effects of IQOS electronic cigarette use."
11328845|NCT03435562|OG002|Outcome|Own Brand Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (each session will be approximately 3 hours).~Own Brand cigarette: Effects of own brand cigarette use."
11328846|NCT03435562|OG000|Outcome|Own Brand Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (each session will be approximately 3 hours).~Own Brand cigarette: Effects of own brand cigarette use."
11328847|NCT03435562|OG001|Outcome|JUUL Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (each session will be approximately 3 hours).~JUUL electronic cigarette: Effects of JUUL electronic cigarette use."
11328848|NCT03435562|OG002|Outcome|IQOS Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (each session will be approximately 3 hours).~IQOS electronic cigarette: Effects of IQOS electronic cigarette use."
11328849|NCT03435562|EG000|Reported Event|JUUL Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (each session will be approximately 3 hours).~JUUL electronic cigarette: Effects of JUUL electronic cigarette use."
11328850|NCT03435562|EG001|Reported Event|IQOS Electronic Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (each session will be approximately 3 hours).~IQOS electronic cigarette: Effects of IQOS electronic cigarette use."
11328851|NCT03435562|EG002|Reported Event|Own Brand Cigarette Use|"During each session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (each session will be approximately 3 hours).~Own Brand cigarette: Effects of own brand cigarette use."
11328852|NCT03435614|BG000|Baseline|Opioid Iatrogenic WIthdrawal Syndrome (OIWS) Positive Patients|Mechanically ventilated critically ill adults receiving regular opioids for more than 72 hours whose at least one daily DSM-5 assessment for OIWS was positive following the reduction in opioid dose (opioid dose reduction of 10% or greater).
11328853|NCT03435614|BG001|Baseline|Opioid Iatrogenic Withdrawal Syndrome (OIWS) Negative Patients|Mechanically ventilated critically ill adults receiving regular opioids for more than 72 hours whose daily DSM-5 assessments for OIWS remained negative for the duration of follow up following the reduction in opioid dose (opioid dose reduction of 10% or greater).
11328854|NCT03435614|BG002|Baseline|Total|Total of all reporting groups
11328855|NCT03435614|FG000|Participant Flow|Iatrogenic Withdrawal Syndrome (IWS) Positive|Group of patients displaying signs and symptoms of IWS
11328856|NCT03435614|FG001|Participant Flow|Iatrogenic Withdrawal Syndrome (IWS) Negative|Group of patients not displaying signs and symptoms of IWS
11328857|NCT03435614|OG000|Outcome|IWS Positive|Group of patients with OIWS positive as per DSM-V criteria
11328858|NCT03435614|OG001|Outcome|IWS Negative|Group of patients without OIWS as per DSM-V criteria
11328859|NCT03435614|EG000|Reported Event|Critically Ill Patients|"Mechanically ventilated critically ill adults receiving regular opioids for more than 72 hours will be prospectively followed for the emergence of withdrawal symptoms upon weaning of opioids.~Opioids: Once an opioid dose reduction of 10% or greater is achieved, a daily assessment will be conducted by a physician using the DSM-5 criteria for opioid withdrawal. In addition, signs and symptoms of withdrawal will be collected daily by a blinded investigator."
11328860|NCT03435692|BG000|Baseline|Lumbar Epidural Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328861|NCT03435692|BG001|Baseline|Lumbar Plexus Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328862|NCT03435692|BG002|Baseline|Lumbar Epidural Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328863|NCT03435692|BG003|Baseline|Lumbar Plexus Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328864|NCT03435692|BG004|Baseline|Patient Controlled Analgesia (6 Years and Older)|Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
11328865|NCT03435692|BG005|Baseline|Total|Total of all reporting groups
11328866|NCT03435692|FG000|Participant Flow|Lumbar Epidural Catheter|"Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.~An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen."
11328867|NCT03435692|FG001|Participant Flow|Lumbar Plexus Catheter|"Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.~An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with PRN morphine and oxycodone as well as scheduled acetaminophen."
11336208|NCT03563183|FG000|Participant Flow|Overall Group|Adults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study
10840250|NCT00226941|FG001|Participant Flow|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85mg/m², Days 2 and 23"
11328868|NCT03435692|FG002|Participant Flow|Patient Controlled Analgesia|"Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.~An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with PRN morphine and oxycodone as well as scheduled acetaminophen."
11328869|NCT03435692|OG000|Outcome|Lumbar Epidural Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328870|NCT03435692|OG001|Outcome|Lumbar Plexus Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328871|NCT03435692|OG002|Outcome|Lumbar Epidural Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328872|NCT03435692|OG003|Outcome|Lumbar Plexus Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328873|NCT03435692|OG004|Outcome|Patient Controlled Analgesia (6 Years and Older)|Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
11328874|NCT03435692|EG000|Reported Event|Lumbar Epidural Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328875|NCT03435692|EG001|Reported Event|Lumbar Plexus Catheter (< 6 Years Old)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328876|NCT03435692|EG002|Reported Event|Lumbar Epidural Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328877|NCT03435692|EG003|Reported Event|Lumbar Plexus Catheter (6 Years and Older)|Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
11328878|NCT03435692|EG004|Reported Event|Patient Controlled Analgesia (6 Years and Older)|Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
11328879|NCT03435783|BG000|Baseline|Intervention|Brief Electronic Intervention: The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.
11328880|NCT03435783|BG001|Baseline|Attention-matched Control|Attention-Matched Control: Participants will view a video clip on general health promotion that is a similar length as the intervention arm.
11328881|NCT03435783|BG002|Baseline|Total|Total of all reporting groups
11328882|NCT03435783|FG000|Participant Flow|Standard Post-test Counseling (Control)|Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.
11328883|NCT03435783|FG001|Participant Flow|Brief Web-based Intervention|This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
11328884|NCT03435783|OG000|Outcome|Standard Post-test Counseling (Control)|Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.
11328885|NCT03435783|OG001|Outcome|Brief Web-based Intervention|This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
11328886|NCT03435783|EG000|Reported Event|Standard Post-test Counseling (Control)|Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk.
11328887|NCT03435783|EG001|Reported Event|Brief Web-based Intervention|This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started.
11328888|NCT03436082|BG000|Baseline|Bariatric|(Sleeve Gastrectomy/Roux-en-Y)
11328889|NCT03436082|BG001|Baseline|AF Ablation|Atrial Fibrillation Ablation
11328890|NCT03436082|BG002|Baseline|Total|Total of all reporting groups
11328891|NCT03436082|FG000|Participant Flow|Bariatric|(Sleeve Gastrectomy/Roux-en-Y)
11328892|NCT03436082|FG001|Participant Flow|AF Ablation|Atrial Fibrillation Ablation
11328893|NCT03436082|OG000|Outcome|Bariatric|(Sleeve Gastrectomy/Roux-en-Y)
11328894|NCT03436082|OG001|Outcome|AF Ablation|Atrial Fibrillation Ablation
11328895|NCT03436082|EG000|Reported Event|Bariatric|(Sleeve Gastrectomy/Roux-en-Y)
11328896|NCT03436082|EG001|Reported Event|AF Ablation|Atrial Fibrillation Ablation
11336209|NCT03563183|OG000|Outcome|Overall Group|Adults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study
11328897|NCT03436147|BG000|Baseline|Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH)|"Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)~POP-Q: Pelvic Organ Prolapse Quantification"
11328898|NCT03436147|BG001|Baseline|Vaginal Hysterectomy and Vaginal Vault Suspensio (VAH+VVS)|"Patients who were performed a vaginal hysterectomy and Vaginal Vault Suspension (VAH + VVS)~POP-Q: Pelvic Organ Prolapse Quantification"
11328899|NCT03436147|BG002|Baseline|Total|Total of all reporting groups
11328900|NCT03436147|FG000|Participant Flow|Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH)|Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)
11328901|NCT03436147|FG001|Participant Flow|Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS)|Patients who were performed a vaginal hysterectomy and Vaginal vault suspension
11328902|NCT03436147|OG000|Outcome|Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH)|"Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)~POP-Q: Pelvic Organ Prolapse Quantification"
11328903|NCT03436147|OG001|Outcome|Vaginal Hysterectomy and Vaginal Vault Suspension (VAH+VVS)|"Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS)~POP-Q: Pelvic Organ Prolapse Quantification"
11328904|NCT03436147|OG000|Outcome|Vaginal Assisted Laparoscopic Sacrohysteropexy(VALS)|"Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)~POP-Q: Pelvic Organ Prolapse Quantification"
11328905|NCT03436147|OG001|Outcome|Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS)|"Patients who were performed vaginal hysterectomy and Vaginal vault suspension~POP-Q: Pelvic Organ Prolapse Quantification"
11328906|NCT03436147|EG000|Reported Event|Vaginal Assisted Laparoscopic Sacrohysteropexy(VALS)|"Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)~POP-Q: Pelvic Organ Prolapse Quantification"
11328907|NCT03436147|EG001|Reported Event|Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS)|"Patients who were performed vaginal hysterectomy and Vaginal vault suspension~POP-Q: Pelvic Organ Prolapse Quantification"
11328908|NCT03436420|BG000|Baseline|Gemcabene|Children with NAFLD receiving 12 weeks of treatment with gemcabene
11328909|NCT03436420|FG000|Participant Flow|Gemcabene|Children with nonalcoholic fatty liver disease (NAFLD) receiving 12 weeks of treatment with gemcabene
11328910|NCT03436420|OG000|Outcome|Gemcabene|Children with NAFLD receiving 12 weeks of treatment with gemcabene
11328911|NCT03436420|EG000|Reported Event|Gemcabene|Children with NAFLD receiving 12 weeks of treatment with gemcabene
11328912|NCT03436732|BG000|Baseline|140 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328913|NCT03436732|BG001|Baseline|100 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328914|NCT03436732|BG002|Baseline|Total|Total of all reporting groups
11328915|NCT03436732|FG000|Participant Flow|140 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328916|NCT03436732|FG001|Participant Flow|100 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328917|NCT03436732|OG000|Outcome|140 mcg/kg|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328918|NCT03436732|OG001|Outcome|100 mcg/kg|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328919|NCT03436732|OG000|Outcome|1/Dose Escalation|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328920|NCT03436732|EG000|Reported Event|140 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328921|NCT03436732|EG001|Reported Event|100 mcg/kg LMB-100 + SEL-110|"Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses~LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles~SEL-110: administered on day 1 of each cycle for up to 4 cycles"
11328922|NCT03436810|BG000|Baseline|Experimental Group|"The experimental group will receive training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration of program session will be 90 minutes. Training for 3 times a week over duration of 4 weeks.~Motor imagery: Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11335723|NCT03555266|EG001|Reported Event|Sham NSS-2 BRIDGE and ERAS Protocol|"The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol~Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol."
11328923|NCT03436810|BG001|Baseline|Control Group|"The control group receives programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They will be trained for 3 times a week over duration of 4 weeks.~Health education: Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11328924|NCT03436810|BG002|Baseline|Total|Total of all reporting groups
11328925|NCT03436810|FG000|Participant Flow|Experimental Group|"The experimental group will receive training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration of program session will be 90 minutes. Training for 3 times a week over duration of 4 weeks.~Motor imagery: Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11328926|NCT03436810|FG001|Participant Flow|Control Group|"The control group receives programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They will be trained for 3 times a week over duration of 4 weeks.~Health education: Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11328927|NCT03436810|OG000|Outcome|Experimental Group|"The experimental group will receive training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration of program session will be 90 minutes. Training for 3 times a week over duration of 4 weeks.~Motor imagery: Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11328928|NCT03436810|OG001|Outcome|Control Group|"The control group receives programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They will be trained for 3 times a week over duration of 4 weeks.~Health education: Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed."
11328929|NCT03436810|EG000|Reported Event|Control Group|"The control group received programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They were trained for 3 times a week over duration of 4 weeks.~Health education: Topic of Health education (HE) consisted of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consisted of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast"
11328930|NCT03436810|EG001|Reported Event|Experimental Group|"The experimental group received training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Training for 3 times a week over duration of 4 weeks.~Motor imagery: Motor imagery (MI) was trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.~Task-Oriented Circuit Class Training: Program of Task-Oriented Circuit Class Training (TOCCT) consisted of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking"
11328931|NCT03437031|BG000|Baseline|Latent-Control|Patients in the latent phase of labor who will receive no intervention.
11335724|NCT03555305|BG000|Baseline|Overall|Participants received 0.5 U/Kg of Insulin glargine and Lantus subcutaneously as per dosing schedule.
11335725|NCT03555305|FG000|Participant Flow|Sequence 1|"Period 1: Participants received 0.5 units per kilogram (U/kg) of Insulin glargine subcutaneously.~Period 2: Participants received 0.5 U/Kg of Lantus subcutaneously."
11328932|NCT03437031|BG001|Baseline|Latent-VR|"Patients in the latent phase of labor who will receive the VR intervention.~Virtual Reality device: For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention."
11328933|NCT03437031|BG002|Baseline|Total|Total of all reporting groups
11328934|NCT03437031|FG000|Participant Flow|Latent-Control|Patients in the latent phase of labor who will receive no intervention.
11328935|NCT03437031|FG001|Participant Flow|Latent-VR|"Patients in the latent phase of labor who will receive the VR intervention.~Virtual Reality device: For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention."
11328936|NCT03437031|OG000|Outcome|Latent-Control|Patients in the latent phase of labor who will receive no intervention.
11328937|NCT03437031|OG001|Outcome|Latent-VR|"Patients in the latent phase of labor who will receive the VR intervention.~Virtual Reality device: For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention."
11328938|NCT03437031|EG000|Reported Event|Latent-Control|Patients in the latent phase of labor who will receive no intervention.
11328939|NCT03437031|EG001|Reported Event|Latent-VR|"Patients in the latent phase of labor who will receive the VR intervention.~Virtual Reality device: For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention."
11328940|NCT03437031|EG002|Reported Event|Active-Control|Patients in the active phase of labor who will receive no intervention.
11328941|NCT03437031|EG003|Reported Event|Active-VR|"Patients in the active phase of labor who will receive the VR intervention.~Virtual Reality device: For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention."
11328942|NCT03437044|BG000|Baseline|Ticagrelor|"180 mg loading dose (LD) followed by a 60 mg bid maintenance (MD) starting 12 h (± 1 h) after the LD~Ticagrelor: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328943|NCT03437044|BG001|Baseline|Clopidogrel|"600 mg LD followed by a 75 mg od MD starting 24 hours (± 1 h) after the LD~Clopidogrel: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328944|NCT03437044|BG002|Baseline|Total|Total of all reporting groups
11328945|NCT03437044|FG000|Participant Flow|Ticagrelor|"180 mg loading dose (LD) followed by a 60 mg bid maintenance (MD) starting 12 h (± 1 h) after the LD~Ticagrelor: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328946|NCT03437044|FG001|Participant Flow|Clopidogrel|"600 mg LD followed by a 75 mg od MD starting 24 hours (± 1 h) after the LD~Clopidogrel: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328947|NCT03437044|OG000|Outcome|Ticagrelor|"180 mg loading dose (LD) followed by a 60 mg bid maintenance (MD) starting 12 h (± 1 h) after the LD~Ticagrelor: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328948|NCT03437044|OG001|Outcome|Clopidogrel|"600 mg LD followed by a 75 mg od MD starting 24 hours (± 1 h) after the LD~Clopidogrel: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11335726|NCT03555305|FG001|Participant Flow|Sequence 2|Period 1: Participants received 0.5 U/Kg of Lantus subcutaneously. Period 2: Participants received 0.5 U/Kg of Insulin glargine subcutaneously.
11328949|NCT03437044|EG000|Reported Event|Ticagrelor|"180 mg loading dose (LD) followed by a 60 mg bid maintenance (MD) starting 12 h (± 1 h) after the LD~Ticagrelor: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328950|NCT03437044|EG001|Reported Event|Clopidogrel|"600 mg LD followed by a 75 mg od MD starting 24 hours (± 1 h) after the LD~Clopidogrel: After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days."
11328951|NCT03437265|BG000|Baseline|Overall Study|All subjects who received at least a partial dose of IMP
11328952|NCT03437265|FG000|Participant Flow|Overall Study|Healthy adult subjects given PLENVU powder for oral solution: PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)
11328953|NCT03437265|OG000|Outcome|Overall Study|All subjects who received at least a partial dose of IMP.
11328954|NCT03437265|EG000|Reported Event|Overall Study|All subjects who received at least a partial dose of IMP.
11328955|NCT03437447|BG000|Baseline|First Cisticid, Then Biltricide, Then Biltricide|Participants received single oral dose of 1200 milligrams (mg) (two 600 mg tablets) Cisticid (Test) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Biltricide (Reference) on Day 8 in Treatment Period 2 and on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328956|NCT03437447|BG001|Baseline|First Biltricide, Then Cisticid, Then Biltricide|Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 8 in Treatment Period 2 and then single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328957|NCT03437447|BG002|Baseline|First Biltricide, Then Biltricide, Then Cisticid|Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 and on Day 8 in Treatment Period 2 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328958|NCT03437447|BG003|Baseline|Total|Total of all reporting groups
11328959|NCT03437447|FG000|Participant Flow|First Cisticid, Then Biltricide, Then Biltricide|Participants received single oral dose of 1200 milligrams (mg) (two 600 mg tablets) Cisticid (Test) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Biltricide (Reference) on Day 8 in Treatment Period 2 and on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328960|NCT03437447|FG001|Participant Flow|First Biltricide, Then Cisticid, Then Biltricide|Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 8 in Treatment Period 2 and then single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328961|NCT03437447|FG002|Participant Flow|First Biltricide, Then Biltricide, Then Cisticid|Participants received single oral dose of 1200 mg (two 600 mg tablets) Biltricide (Reference) on Day 1 in Treatment Period 1 and on Day 8 in Treatment Period 2 followed by single oral dose of 1200 mg (two 600 mg tablets) of Cisticid (Test) on Day 15 in Treatment Period 3. A washout period will be maintained between 3 treatment periods.
11328962|NCT03437447|OG000|Outcome|Cisticid|All participants who received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
11328963|NCT03437447|OG001|Outcome|Biltricide First Administration|All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
11328964|NCT03437447|OG002|Outcome|Biltricide Second Administration|All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
11328965|NCT03437447|EG000|Reported Event|Cisticid|All participants who received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
11328966|NCT03437447|EG001|Reported Event|Biltricide First Administration|All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
11328967|NCT03437447|EG002|Reported Event|Biltricide Second Administration|All participants who received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
11328968|NCT03437512|BG000|Baseline|Active tDCS and Fluency Training|"Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).~Anodal tDCS: 20 minutes of 2mA anodal stimulation.~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes"
11328969|NCT03437512|BG001|Baseline|Sham tDCS and Fluency Training|"Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes~Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds."
11328970|NCT03437512|BG002|Baseline|Total|Total of all reporting groups
11328971|NCT03437512|FG000|Participant Flow|Active tDCS and Fluency Training|"Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).~Anodal tDCS: 20 minutes of 2mA anodal stimulation.~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes"
10840251|NCT00226941|FG002|Participant Flow|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
10840252|NCT00226941|FG003|Participant Flow|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
11328972|NCT03437512|FG001|Participant Flow|Sham tDCS and Fluency Training|"Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes~Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds."
11328973|NCT03437512|OG000|Outcome|Active tDCS and Fluency Training|"Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).~Anodal tDCS: 20 minutes of 2mA anodal stimulation.~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes"
11328974|NCT03437512|OG001|Outcome|Sham tDCS and Fluency Training|"Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes~Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds."
11328975|NCT03437512|EG000|Reported Event|Active tDCS and Fluency Training|"Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).~Anodal tDCS: 20 minutes of 2mA anodal stimulation.~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes"
11328976|NCT03437512|EG001|Reported Event|Sham tDCS and Fluency Training|"Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).~Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes~Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds."
11328977|NCT03437564|BG000|Baseline|Vortioxetine One 20 mg Tablet + Two 10 mg Tablets|Vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 2 in a fasted state.
11328978|NCT03437564|BG001|Baseline|Vortioxetine Two 10 mg Tablets + One 20 mg Table|Vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 2 in a fasted state.
11328979|NCT03437564|BG002|Baseline|Total|Total of all reporting groups
11328980|NCT03437564|FG000|Participant Flow|Vortioxetine One 20 mg Tablet + Two 10 mg Tablets|Vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 2 in a fasted state.
11328981|NCT03437564|FG001|Participant Flow|Vortioxetine Two 10 mg Tablets + One 20 mg Tablet|Vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 2 in a fasted state.
11328982|NCT03437564|OG000|Outcome|Vortioxetine One 20 mg Tablet|Vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 1 in a fasted state plus Day 1 in Period 2 in a fasted state.
11328983|NCT03437564|OG001|Outcome|Vortioxetine Two 10 mg Tablets|Vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 1 in a fasted state plus Day 1 in Period 2 in a fasted state.
11328984|NCT03437564|EG000|Reported Event|Vortioxetine One 20 mg Tablet|Vortioxetine 20 mg (one 20 mg tablet) orally, once on Day 1 in Period 1 in a fasted state plus Day 1 in Period 2 in a fasted state.
11328985|NCT03437564|EG001|Reported Event|Vortioxetine Two 10 mg Tablets|Vortioxetine 20 mg (two 10 mg tablets) orally, once on Day 1 in Period 1 in a fasted state plus Day 1 in Period 2 in a fasted state.
11328986|NCT03437577|BG000|Baseline|Immediate-Release Tacrolimus|"This is standard of care~immediate-release tacrolimus: Standard of care for transplant patients"
11328987|NCT03437577|BG001|Baseline|Extended-Release Tacrolimus|"replace standard of care~extended release tacrolimus: Experimental care"
10840253|NCT00226941|OG000|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
11328988|NCT03437577|BG002|Baseline|Non-Randomized|Participants in this arm were not randomized to either arm. They ended study participation prior to randomization.
11328989|NCT03437577|BG003|Baseline|Total|Total of all reporting groups
11328990|NCT03437577|FG000|Participant Flow|Immediate-Release Tacrolimus|"This is standard of care~immediate-release tacrolimus: Standard of care for transplant patients"
11328991|NCT03437577|FG001|Participant Flow|Extended-Release Tacrolimus|"replace standard of care~extended release tacrolimus: Experimental care"
11328992|NCT03437577|FG002|Participant Flow|Non-Randomized|Participants in this arm were not randomized to either arm. They ended study participation prior to randomization.
11328993|NCT03437577|OG000|Outcome|Immediate-Release Tacrolimus|"This is standard of care~immediate-release tacrolimus: Standard of care for transplant patients"
11328994|NCT03437577|OG001|Outcome|Extended-Release Tacrolimus|"replace standard of care~extended release tacrolimus: Experimental care"
11328995|NCT03437577|EG000|Reported Event|Immediate-Release Tacrolimus|"This is standard of care~immediate-release tacrolimus: Standard of care for transplant patients"
11328996|NCT03437577|EG001|Reported Event|Extended-Release Tacrolimus|"replace standard of care~extended release tacrolimus: Experimental care"
11328997|NCT03437733|BG000|Baseline|Roll-in Study Phase: Radiofrequency (RF) Ablation|Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.
11328998|NCT03437733|BG001|Baseline|Main Study Phase: RF Ablation|RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
11328999|NCT03437733|BG002|Baseline|Total|Total of all reporting groups
11329000|NCT03437733|FG000|Participant Flow|Roll-in Study Phase: RF Ablation|Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.
11329001|NCT03437733|FG001|Participant Flow|Main Study Phase: RF Ablation|RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
11329002|NCT03437733|OG000|Outcome|Radiofrequency (RF) Ablation|RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
11329003|NCT03437733|EG000|Reported Event|Roll-in Study Phase: RF Ablation|Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.
11329004|NCT03437733|EG001|Reported Event|Main Study Phase: RF Ablation|RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
11329005|NCT03437863|BG000|Baseline|Mobile Application|"Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.~Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals."
11329006|NCT03437863|FG000|Participant Flow|Mobile Application|"Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.~Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals."
11329007|NCT03437863|OG000|Outcome|Mobile Application|"Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.~Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals."
11329008|NCT03437863|EG000|Reported Event|Mobile Application|"Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.~Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals."
11329009|NCT03438006|BG000|Baseline|Cervarix Group|Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
11329010|NCT03438006|FG000|Participant Flow|Cervarix Group|Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
11329011|NCT03438006|OG000|Outcome|Cervarix Group|Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
11329012|NCT03438006|EG000|Reported Event|Cervarix Group|Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
11329013|NCT03438045|BG000|Baseline|Partnered Intervention|"The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors.~Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists."
11329014|NCT03438045|FG000|Participant Flow|Partnered Intervention|"The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors.~Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists."
11335727|NCT03555305|OG000|Outcome|0.5 U/kg Insulin Glargine|Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
11335728|NCT03555305|OG001|Outcome|0.5 U/kg Lantus|Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
11335729|NCT03555305|EG000|Reported Event|0.5 U/kg Insulin Glargine|Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously.
11335730|NCT03555305|EG001|Reported Event|0.5 U/kg Lantus|Participants received single 0.5 U/kg dose of Lantus administered subcutaneously.
11329015|NCT03438045|OG000|Outcome|Partnered Intervention|"The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors.~Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists."
11329016|NCT03438045|EG000|Reported Event|Partnered Intervention|"The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors.~Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists."
11329017|NCT03438266|BG000|Baseline|JUVÉDERM VOLUMA® XC (All Participants)|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
11329018|NCT03438266|FG000|Participant Flow|JUVÉDERM VOLUMA® XC (All Participants)|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
11329019|NCT03438266|OG000|Outcome|JUVÉDERM VOLUMA® XC Injectable Gel With Cannula|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
11329020|NCT03438266|OG001|Outcome|JUVÉDERM VOLUMA® XC Injectable Gel With Needle|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
11329021|NCT03438266|OG000|Outcome|JUVÉDERM VOLUMA® XC (All Participants)|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
11329022|NCT03438266|EG000|Reported Event|JUVÉDERM VOLUMA® XC (All Participants)|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
11329023|NCT03438383|BG000|Baseline|Sham Bi-PAP|"Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.~Sham Bi-PAP: Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O."
11329024|NCT03438383|BG001|Baseline|Bi-PAP|"Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.~Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose."
11329025|NCT03438383|BG002|Baseline|Total|Total of all reporting groups
11329026|NCT03438383|FG000|Participant Flow|Sham Bi-PAP|"Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeters of water (cm H2O).~Sham Bi-PAP: Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O."
11329027|NCT03438383|FG001|Participant Flow|Bi-PAP|"Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of oxygen saturation by pulse oximetry (SpO2), PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.~Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as chronic obstructive pulmonary disease (COPD), respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose."
11329028|NCT03438383|OG000|Outcome|Sham Bi-PAP|"Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.~Sham Bi-PAP: Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O."
11335731|NCT03555435|BG000|Baseline|On Your Own|Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.
11336210|NCT03563183|OG000|Outcome|Non-Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as non-frail.
11329029|NCT03438383|OG001|Outcome|Bi-PAP|"Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.~Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose."
11329030|NCT03438383|EG000|Reported Event|Sham Bi-PAP|"Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.~Sham Bi-PAP: Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O."
11329031|NCT03438383|EG001|Reported Event|Bi-PAP|"Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.~Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose."
11329032|NCT03438396|BG000|Baseline|Tisotumab Vedotin|Participants received intravenous (IV) tisotumab vedotin 2.0 mg/kg every 3 weeks (Q3W) until radiographic disease progression verified by the Independent review committee (IRC), unacceptable adverse events (AEs) requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
11329033|NCT03438396|FG000|Participant Flow|Tisotumab Vedotin|Participants received intravenous (IV) tisotumab vedotin 2.0 mg/kg every 3 weeks (Q3W) until radiographic disease progression verified by the Independent review committee (IRC), unacceptable adverse events (AEs) requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
11329034|NCT03438396|OG000|Outcome|Tisotumab Vedotin|Participants received intravenous (IV) tisotumab vedotin 2.0 mg/kg every 3 weeks (Q3W) until radiographic disease progression verified by the Independent review committee (IRC), unacceptable adverse events (AEs) requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
11329035|NCT03438396|EG000|Reported Event|Tisotumab Vedotin|Participants received intravenous (IV) tisotumab vedotin 2.0 mg/kg every 3 weeks (Q3W) until radiographic disease progression verified by the Independent review committee (IRC), unacceptable adverse events (AEs) requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
11329036|NCT03438539|BG000|Baseline|Attentional Control With Normative Feedback|"Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender."
11329037|NCT03438539|BG001|Baseline|Inhibitory Control Training With Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329038|NCT03438539|BG002|Baseline|Working Memory Training With Normative Feedback|A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
11329039|NCT03438539|BG003|Baseline|Attentional Control Without Normative Feedback|Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).
11329040|NCT03438539|BG004|Baseline|Inhibitory Control Training Without Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11335732|NCT03555435|BG001|Baseline|Peer Support|Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
11329041|NCT03438539|BG005|Baseline|Working Memory Training Without Normative Feedback|"A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task."
11329042|NCT03438539|BG006|Baseline|Total|Total of all reporting groups
11329043|NCT03438539|FG000|Participant Flow|Attentional Control With Normative Feedback|"Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender."
11329044|NCT03438539|FG001|Participant Flow|Inhibitory Control Training With Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329045|NCT03438539|FG002|Participant Flow|Working Memory Training With Normative Feedback|A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
11329046|NCT03438539|FG003|Participant Flow|Attentional Control Without Normative Feedback|Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).
11329047|NCT03438539|FG004|Participant Flow|Inhibitory Control Training Without Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329048|NCT03438539|FG005|Participant Flow|Working Memory Training Without Normative Feedback|"A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task."
11329049|NCT03438539|OG000|Outcome|Attentional Control With Normative Feedback|"Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender."
11329050|NCT03438539|OG001|Outcome|Inhibitory Control Training With Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329051|NCT03438539|OG002|Outcome|Working Memory Training With Normative Feedback|A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
11335733|NCT03555435|BG002|Baseline|Wait|Wait: Participants in this group will wait 6 weeks.
11335734|NCT03555435|BG003|Baseline|Total|Total of all reporting groups
11329052|NCT03438539|OG003|Outcome|Attentional Control Without Normative Feedback|Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).
11329053|NCT03438539|OG004|Outcome|Inhibitory Control Training Without Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329054|NCT03438539|OG005|Outcome|Working Memory Training Without Normative Feedback|"A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).~Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task."
11329055|NCT03438539|EG000|Reported Event|Attentional Control With Normative Feedback|"Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative~Feedback:~Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender."
11329056|NCT03438539|EG001|Reported Event|Inhibitory Control Training With Normative Feedback|"The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative~Feedback:~Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control."
11329057|NCT03438539|EG002|Reported Event|Working Memory Training With Normative Feedback|A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the nback task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender
11329058|NCT03438539|EG003|Reported Event|Attentional Control Without Normative Feedback|Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a nonalcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).
11329059|NCT03438539|EG004|Reported Event|Inhibitory Control Training Without Normative Feedback|The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a nonalcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.
11329060|NCT03438539|EG005|Reported Event|Working Memory Training Without Normative Feedback|A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the nback task. Subjects assigned to not receive normative feedback received feedback on time spent doing a nonalcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the nback task.
11329061|NCT03438578|BG000|Baseline|Efficacy Safety Score Monitoring|"Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward~Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care."
11329062|NCT03438578|BG001|Baseline|Regular|Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
11329063|NCT03438578|BG002|Baseline|Total|Total of all reporting groups
11329064|NCT03438578|FG000|Participant Flow|Efficacy Safety Score Monitoring|"Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward~Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care."
11329065|NCT03438578|FG001|Participant Flow|Regular|Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
11329066|NCT03438578|OG000|Outcome|Efficacy Safety Score Monitoring|"Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward~Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care."
11329067|NCT03438578|OG001|Outcome|Regular|Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
11329068|NCT03438578|EG000|Reported Event|Efficacy Safety Score Monitoring|"Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward~Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care."
11329069|NCT03438578|EG001|Reported Event|Regular|Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
11329070|NCT03439072|BG000|Baseline|All Randomized Subjects|A total of 81 subjects met eligibility requirements and were randomized to study treatment.
11329071|NCT03439072|FG000|Participant Flow|G-Pen Followed by Lilly Glucagon|"1 mg G-Pen at the first treatment visit followed by 1 mg Lilly Glucagon at the second treatment visit~G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector~Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])"
11329072|NCT03439072|FG001|Participant Flow|Lilly Glucagon Followed by G-Pen|"1 mg Lilly Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit~G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector~Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])"
11329073|NCT03439072|OG000|Outcome|G-Pen|G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
11329074|NCT03439072|OG001|Outcome|Lilly Glucagon|Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
11329075|NCT03439072|EG000|Reported Event|G-Pen|G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector. Between the 2 arms, a total of 76 subjects received a dose of G-Pen in the study.
11329076|NCT03439072|EG001|Reported Event|Lilly Glucagon|Lilly Glucagon: 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin]). Between the 2 arms, a total of 78 subjects received a dose of Lilly Glucagon in the study.
11329077|NCT03439137|BG000|Baseline|MT-6548|"MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.~Darbepoetin alfa matching placebo: Intravenous administration"
11329078|NCT03439137|BG001|Baseline|Darbepoetin Alfa|"Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.~MT-6548-matching placebo: Oral tablet"
11329079|NCT03439137|BG002|Baseline|Total|Total of all reporting groups
11329080|NCT03439137|FG000|Participant Flow|MT-6548|"MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.~Darbepoetin alfa matching placebo: Intravenous administration"
11329081|NCT03439137|FG001|Participant Flow|Darbepoetin Alfa|"Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.~MT-6548-matching placebo: Oral tablet"
11329082|NCT03439137|OG000|Outcome|MT-6548|"MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.~Darbepoetin alfa matching placebo: Intravenous administration"
11329083|NCT03439137|OG001|Outcome|Darbepoetin Alfa|"Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.~MT-6548-matching placebo: Oral tablet"
11329084|NCT03439137|EG000|Reported Event|MT-6548|"MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.~Darbepoetin alfa matching placebo: Intravenous administration"
11329085|NCT03439137|EG001|Reported Event|Darbepoetin Alfa|"Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.~MT-6548-matching placebo: Oral tablet"
11329086|NCT03439189|BG000|Baseline|ACLD With NASH|Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
11329087|NCT03439189|FG000|Participant Flow|ACLD With NASH|Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
11329088|NCT03439189|OG000|Outcome|Subjects With CSPH|Subjects with Hepatic Venous Pressure Gradient (HVPG) equal to or greater than 10 mmHg
11329089|NCT03439189|OG000|Outcome|Number of Subjects With SPH|Number of matched subjects with Severe Portal Hypertension (defined as HVPG>=12mmHg) based on HVPG and MBT.
11329090|NCT03439189|EG000|Reported Event|ACLD With NASH|Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
11333831|NCT03520387|FG004|Participant Flow|Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11333832|NCT03520387|OG000|Outcome|Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11329091|NCT03440229|BG000|Baseline|Emuslfier-free Diet|This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily.
11329092|NCT03440229|BG001|Baseline|Emulsifier-containing Diet|"This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily.~Emulsifier-containing diet: CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota."
11329093|NCT03440229|BG002|Baseline|Total|Total of all reporting groups
11329094|NCT03440229|FG000|Participant Flow|Emuslfier-free Diet|This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily.
11329095|NCT03440229|FG001|Participant Flow|Emulsifier-containing Diet|"This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily.~Emulsifier-containing diet: CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota."
11329096|NCT03440229|OG000|Outcome|Emuslfier-free Diet|This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily.
11329097|NCT03440229|OG001|Outcome|Emulsifier-containing Diet|"This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily.~Emulsifier-containing diet: CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota."
11329098|NCT03440229|EG000|Reported Event|Emuslfier-free Diet|This is western style diet prepared without any emulsifiers. Emulsifier free brownies and sorbet are provided daily.
11329099|NCT03440229|EG001|Reported Event|Emulsifier-containing Diet|"This is a western style diet prepared without any emulsifiers with the exception of the CMC that is included in brownies and sorbet that are provided daily.~Emulsifier-containing diet: CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota."
11329100|NCT03440320|BG000|Baseline|Online Pilot, MY-Skills (Intervention), Caregivers|Participants in the MY-Skills program who provide the most care to their partner (other member of the dyad).
11329101|NCT03440320|BG001|Baseline|Online Pilot, MY-Skills (Intervention), Care Receivers|Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad).
11329102|NCT03440320|BG002|Baseline|Online Pilot, MY-PLAN (Control), Caregivers|Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad).
11329103|NCT03440320|BG003|Baseline|Online Pilot, MY-PLAN (Control), Care Receivers|Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad).
11329104|NCT03440320|BG004|Baseline|Total|Total of all reporting groups
11329105|NCT03440320|FG000|Participant Flow|MY-Skills Intervention - Online|MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
11329106|NCT03440320|FG001|Participant Flow|MY-Plan Control - Online|MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
11329107|NCT03440320|OG000|Outcome|Online Pilot, MY-Skills (Intervention), Caregivers|Participants in the MY-Skills program who provide the most care to their partner (other member of the dyad).
11329108|NCT03440320|OG001|Outcome|Online Pilot, MY-Skills (Intervention), Care Receivers|Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad).
11329109|NCT03440320|OG002|Outcome|Online Pilot, MY-PLAN (Control), Caregivers|Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad).
11329110|NCT03440320|OG003|Outcome|Online Pilot, MY-PLAN (Control), Care Receivers|Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad).
11329111|NCT03440320|EG000|Reported Event|MY-Skills Intervention - Online|MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
11329112|NCT03440320|EG001|Reported Event|MY-Plan Control - Online|MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
11329113|NCT03440411|BG000|Baseline|ARM Pom-dex Early (A-I)|Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11335735|NCT03555435|FG000|Participant Flow|On Your Own|Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.
10840254|NCT00226941|OG001|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
11329114|NCT03440411|BG001|Baseline|ARM Pom-dex Late (A-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329115|NCT03440411|BG002|Baseline|ARM Pom-cyclo-dex Early (B-I)|Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329116|NCT03440411|BG003|Baseline|ARM Pom-cyclo-dex Late (B-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329117|NCT03440411|BG004|Baseline|Total|Total of all reporting groups
11329118|NCT03440411|FG000|Participant Flow|ARM Pom-dex Early (A-I)|Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329119|NCT03440411|FG001|Participant Flow|ARM Pom-dex Late (A-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329120|NCT03440411|FG002|Participant Flow|ARM Pom-cyclo-dex Early (B-I)|Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329121|NCT03440411|FG003|Participant Flow|ARM Pom-cyclo-dex Late (B-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329122|NCT03440411|OG000|Outcome|Arm A|Pd
11329123|NCT03440411|OG001|Outcome|Arm B|CPd
11329124|NCT03440411|OG000|Outcome|Arm I|Early Treatment
11329125|NCT03440411|OG001|Outcome|Arm II|Late treatment
11329126|NCT03440411|OG001|Outcome|Arm II|Late Treatment
11329127|NCT03440411|OG000|Outcome|ARM A-I|Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329128|NCT03440411|OG001|Outcome|ARM A-II|"Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329129|NCT03440411|OG002|Outcome|ARM B-I|Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329130|NCT03440411|OG003|Outcome|ARM B-II|"Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329131|NCT03440411|EG000|Reported Event|ARM Pom-dex Early (A-I)|Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329132|NCT03440411|EG001|Reported Event|ARM Pom-dex Late (A-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11329133|NCT03440411|EG002|Reported Event|ARM Pom-cyclo-dex Early (B-I)|Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
11329134|NCT03440411|EG003|Reported Event|ARM Pom-cyclo-dex Late (B-II)|"Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.~Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance"
11335736|NCT03555435|FG001|Participant Flow|Peer Support|Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
11335737|NCT03555435|FG002|Participant Flow|Wait|Wait: Participants in this group will wait 6 weeks.
11335738|NCT03555435|OG000|Outcome|On Your Own|Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.
10840255|NCT00226941|OG002|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
11329135|NCT03440424|BG000|Baseline|Cohort A: Mild Hepatic Impairment (Child Pugh Class A)|Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329136|NCT03440424|BG001|Baseline|Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)|Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329137|NCT03440424|BG002|Baseline|Cohort C: Healthy Participants (Control)|Healthy participants matched to participants with hepatic impairment in Cohorts A and B (with regards to age, sex, BMI) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period.
11329138|NCT03440424|BG003|Baseline|Total|Total of all reporting groups
11329139|NCT03440424|FG000|Participant Flow|Cohort A: Mild Hepatic Impairment (Child Pugh Class A)|Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received lemborexant 10 milligrams (mg) administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329140|NCT03440424|FG001|Participant Flow|Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)|Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329141|NCT03440424|FG002|Participant Flow|Cohort C: Healthy Participants (Control)|Healthy participants matched to participants with hepatic impairment in Cohorts A and B (with regards to age, sex, body mass index [BMI]) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period.
11329142|NCT03440424|OG000|Outcome|Cohort A: Mild Hepatic Impairment (Child Pugh Class A)|Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329143|NCT03440424|OG001|Outcome|Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)|Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329144|NCT03440424|OG002|Outcome|Cohort C: Healthy Participants (Control)|Healthy participants matched to participants with hepatic impairment in Cohorts A and B (with regards to age, sex, BMI) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period.
11329145|NCT03440424|EG000|Reported Event|Cohort A: Mild Hepatic Impairment (Child Pugh Class A)|Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329146|NCT03440424|EG001|Reported Event|Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)|Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period. The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
11329147|NCT03440424|EG002|Reported Event|Cohort C: Healthy Participants (Control)|Healthy participants matched to participants with hepatic impairment in Cohorts A and B (with regards to age, sex, BMI) received lemborexant 10 mg administered as a tablet, orally in the morning on Day 1 of the 14-day Treatment Period.
10840256|NCT00226941|OG003|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
11329148|NCT03440619|BG000|Baseline|INVSENSOR00013 Sensor|All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
11329149|NCT03440619|FG000|Participant Flow|INVSENSOR00013 Sensor|All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
11329150|NCT03440619|OG000|Outcome|INVSENSOR00013 Sensor|All subjects are enrolled into the test group and received one INVSENSOR00013 sensor.
11329151|NCT03440619|EG000|Reported Event|INVSENSOR00013 Sensor|All subjects are enrolled into the test group and received the INVSENSOR00013 sensor.
11329152|NCT03440723|BG000|Baseline|Standard Dilation Exam|"Participants receive two standard digital cervical dilation examinations conducted by two different physicians.~Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation"
11329153|NCT03440723|BG001|Baseline|Dilation Exam With DilaCheck|"Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.~DilaCheck: Measuring device for the measurement of cervical dilation"
11329154|NCT03440723|BG002|Baseline|Total|Total of all reporting groups
11329155|NCT03440723|FG000|Participant Flow|Standard Dilation Exam|"Participants receive two standard digital cervical dilation examinations conducted by two different physicians.~Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation"
11329156|NCT03440723|FG001|Participant Flow|Dilation Exam With DilaCheck|"Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.~DilaCheck: Measuring device for the measurement of cervical dilation"
11329157|NCT03440723|OG000|Outcome|Standard Dilation Exam|"Participants receive two standard digital cervical dilation examinations conducted by two different physicians.~Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation"
11329158|NCT03440723|OG001|Outcome|Dilation Exam With DilaCheck|"Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.~DilaCheck: Measuring device for the measurement of cervical dilation"
11329159|NCT03440723|OG000|Outcome|Providers Participating in Trial|10 providers participated in the trial providing examinations and provided feedback on ease of use of the device.
11329160|NCT03440723|EG000|Reported Event|Standard Dilation Exam|"Participants receive two standard digital cervical dilation examinations conducted by two different physicians.~Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation"
11329161|NCT03440723|EG001|Reported Event|Dilation Exam With DilaCheck|"Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.~DilaCheck: Measuring device for the measurement of cervical dilation"
11329162|NCT03440918|BG000|Baseline|Usual Care|Usual Care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
11329163|NCT03440918|BG001|Baseline|Procalcitonin-Guided Antimicrobial Stewardship|In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
11329164|NCT03440918|BG002|Baseline|Total|Total of all reporting groups
11329165|NCT03440918|FG000|Participant Flow|Usual Care Antimicrobial Stewardship|Participants received usual care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
11329166|NCT03440918|FG001|Participant Flow|Procalcitonin-Guided Antimicrobial Stewardship|In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
11329167|NCT03440918|OG000|Outcome|Baseline Antimicrobial Stewardship|Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
11329168|NCT03440918|OG001|Outcome|Procalcitonin-Guided Antimicrobial Stewardship|In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
11329169|NCT03440918|EG000|Reported Event|Baseline Antimicrobial Stewardship|Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
11329170|NCT03440918|EG001|Reported Event|Procalcitonin-Guided Antimicrobial Stewardship|In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
11329171|NCT03440944|BG000|Baseline|Ultrasound Guided Peripheral IV Catheter|"Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length.~Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter."
11329172|NCT03440944|BG001|Baseline|Midline Catheter|"Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.~Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length."
11329173|NCT03440944|BG002|Baseline|Total|Total of all reporting groups
11329174|NCT03440944|FG000|Participant Flow|Ultrasound Guided Peripheral IV Catheter|"Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.~Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter."
11329175|NCT03440944|FG001|Participant Flow|Midline Catheter|"Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.~Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length."
11329176|NCT03440944|OG000|Outcome|Ultrasound Guided Peripheral IV Catheter|"Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.~Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter."
11329177|NCT03440944|OG001|Outcome|Midline Catheter|"Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.~Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length."
11329178|NCT03440944|OG000|Outcome|Ultrasound Guided Peripheral IV Catheter|"Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length.~Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter."
11329179|NCT03440944|EG000|Reported Event|Ultrasound Guided Peripheral IV Catheter|"Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.~Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter."
11329180|NCT03440944|EG001|Reported Event|Midline Catheter|"Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.~Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length."
11329181|NCT03441178|BG000|Baseline|ENSEAL X1 Large Jaw Tissue Sealer|Use of the ENSEAL X1 Large Jaw Tissue Sealer
11329182|NCT03441178|FG000|Participant Flow|Colectomy|Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329183|NCT03441178|FG001|Participant Flow|Gynecological|Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329184|NCT03441178|FG002|Participant Flow|Thoracic|Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329185|NCT03441178|OG000|Outcome|Colectomy|Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329186|NCT03441178|OG001|Outcome|Gynecological|Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329187|NCT03441178|OG002|Outcome|Thoracic|Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329188|NCT03441178|OG003|Outcome|Total|Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329189|NCT03441178|OG000|Outcome|Gynecological|Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329190|NCT03441178|OG001|Outcome|Thoracic|Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329191|NCT03441178|OG002|Outcome|Total|Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
11329192|NCT03441178|EG000|Reported Event|ENSEAL X1 Large Jaw Tissue Sealer|Use of the ENSEAL X1 Large Jaw Tissue Sealer
11329193|NCT03441269|BG000|Baseline|400mg/Dose|"Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329194|NCT03441269|BG001|Baseline|600mg/Dose|"Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329195|NCT03441269|BG002|Baseline|800mg/Dose|"Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329196|NCT03441269|BG003|Baseline|Total|Total of all reporting groups
11329197|NCT03441269|FG000|Participant Flow|400mg/Dose|"Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329198|NCT03441269|FG001|Participant Flow|600mg/Dose|"Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329199|NCT03441269|FG002|Participant Flow|800mg/Dose|"Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329200|NCT03441269|OG000|Outcome|400mg/Dose|"Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329201|NCT03441269|OG001|Outcome|600mg/Dose|"Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329202|NCT03441269|OG002|Outcome|800mg/Dose|"Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329203|NCT03441269|EG000|Reported Event|400mg/Dose|"Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329204|NCT03441269|EG001|Reported Event|600mg/Dose|"Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329205|NCT03441269|EG002|Reported Event|800mg/Dose|"Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.~Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg"
11329206|NCT03441581|BG000|Baseline|Eluxadoline 100 mg With BAM|IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
11329207|NCT03441581|BG001|Baseline|Eluxadoline 100 mg Without BAM|IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
11329208|NCT03441581|BG002|Baseline|Total|Total of all reporting groups
11329209|NCT03441581|FG000|Participant Flow|Eluxadoline 100 mg With BAM|IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
11329210|NCT03441581|FG001|Participant Flow|Eluxadoline 100 mg Without BAM|IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
11329211|NCT03441581|OG000|Outcome|Eluxadoline 100 mg With BAM|IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
11329212|NCT03441581|OG001|Outcome|Eluxadoline 100 mg Without BAM|IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
11329213|NCT03441581|EG000|Reported Event|Eluxadoline 100 mg With BAM|IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
11329214|NCT03441581|EG001|Reported Event|Eluxadoline 100 mg Without BAM|IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
11329215|NCT03441594|BG000|Baseline|Single Group|The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
11329216|NCT03441594|FG000|Participant Flow|Single Group|The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
11329217|NCT03441594|OG000|Outcome|Single Group|The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
11329218|NCT03441594|EG000|Reported Event|Single Group|The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.
11329219|NCT03441633|BG000|Baseline|Apixaban: Naive|Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
11329220|NCT03441633|BG001|Baseline|Apixaban: Non Naive|Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329221|NCT03441633|BG002|Baseline|Acenocoumarol: Naive|Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329222|NCT03441633|BG003|Baseline|Acenocoumarol: Non-Naive|Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329223|NCT03441633|BG004|Baseline|Warfarin: Naive|Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329224|NCT03441633|BG005|Baseline|Warfarin: Non Naive|Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329225|NCT03441633|BG006|Baseline|Dabigatran: Naive|Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329226|NCT03441633|BG007|Baseline|Dabigatran: Non-Naive|Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329227|NCT03441633|BG008|Baseline|Rivaroxaban: Naive|Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329228|NCT03441633|BG009|Baseline|Rivaroxaban: Non-Naive|Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329229|NCT03441633|BG010|Baseline|Total|Total of all reporting groups
11329230|NCT03441633|FG000|Participant Flow|Apixaban: Naive|Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
11329231|NCT03441633|FG001|Participant Flow|Apixaban: Non Naive|Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329232|NCT03441633|FG002|Participant Flow|Acenocoumarol: Naive|Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329233|NCT03441633|FG003|Participant Flow|Acenocoumarol: Non-Naive|Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329234|NCT03441633|FG004|Participant Flow|Warfarin: Naive|Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329235|NCT03441633|FG005|Participant Flow|Warfarin: Non-Naive|Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329236|NCT03441633|FG006|Participant Flow|Dabigatran: Naive|Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11336211|NCT03563183|OG001|Outcome|Non-Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as non-frail.
11329237|NCT03441633|FG007|Participant Flow|Dabigatran: Non-Naive|Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329238|NCT03441633|FG008|Participant Flow|Rivaroxaban: Naive|Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329239|NCT03441633|FG009|Participant Flow|Rivaroxaban: Non-Naive|Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329240|NCT03441633|OG000|Outcome|Apixaban: Naive|Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
11329241|NCT03441633|OG001|Outcome|Apixaban: Non Naive|Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329242|NCT03441633|OG002|Outcome|Acenocoumarol: Naive|Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329243|NCT03441633|OG003|Outcome|Acenocoumarol: Non-Naive|Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329244|NCT03441633|OG004|Outcome|Warfarin: Naive|Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329245|NCT03441633|OG005|Outcome|Warfarin: Non-Naive|Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329246|NCT03441633|OG006|Outcome|Dabigatran: Naive|Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329247|NCT03441633|OG007|Outcome|Dabigatran: Non-Naive|Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329248|NCT03441633|OG008|Outcome|Rivaroxaban: Naive|Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329249|NCT03441633|OG009|Outcome|Rivaroxaban: Non-Naive|Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329250|NCT03441633|OG000|Outcome|Acenocoumarol: Naive|Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329251|NCT03441633|OG001|Outcome|Acenocoumarol: Non-Naive|Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329252|NCT03441633|OG002|Outcome|Warfarin: Naive|Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329253|NCT03441633|OG003|Outcome|Warfarin: Non-Naive|Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329254|NCT03441633|EG000|Reported Event|Apixaban: Naive|Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
11336212|NCT03563183|OG002|Outcome|Pre-Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as pre-frail.
10840257|NCT00226941|OG001|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85mg/m², Days 2 and 23"
10840258|NCT00226941|OG002|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
10840259|NCT00226941|OG000|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
10840260|NCT00226941|OG001|Outcome|Group 2 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
10840261|NCT00226941|OG001|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 850 mg/m², Days 2 and 23"
10840262|NCT00226941|OG003|Outcome|Group B - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
10840263|NCT00226941|EG000|Reported Event|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
10840264|NCT00226941|EG001|Reported Event|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
11329255|NCT03441633|EG001|Reported Event|Apixaban: Non Naive|Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329256|NCT03441633|EG002|Reported Event|Acenocoumarol: Naive|Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329257|NCT03441633|EG003|Reported Event|Acenocoumarol: Non-Naive|Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329258|NCT03441633|EG004|Reported Event|Warfarin: Naive|Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329259|NCT03441633|EG005|Reported Event|Warfarin: Non Naive|Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329260|NCT03441633|EG006|Reported Event|Dabigatran: Naive|Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329261|NCT03441633|EG007|Reported Event|Dabigatran: Non-Naive|Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329262|NCT03441633|EG008|Reported Event|Rivaroxaban: Naive|Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
11329263|NCT03441633|EG009|Reported Event|Rivaroxaban: Non-Naive|Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
11329264|NCT03441789|BG000|Baseline|Otezla Plus Enstilar Foam|"Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily~Enstilar: Enstilar foam applied to affected areas daily~Otezla: Otezla 30mg"
11329265|NCT03441789|BG001|Baseline|Otezla Plus Vehicle Foam|"Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily~Vehicle: vehicle foam applied to affected areas once daily~Otezla: Otezla 30mg"
11329266|NCT03441789|BG002|Baseline|Total|Total of all reporting groups
11329267|NCT03441789|FG000|Participant Flow|Otezla Plus Enstilar Foam|"Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily~Enstilar: Enstilar foam applied to affected areas daily~Otezla: Otezla 30mg"
11329268|NCT03441789|FG001|Participant Flow|Otezla Plus Vehicle Foam|"Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily~Vehicle: vehicle foam applied to affected areas once daily~Otezla: Otezla 30mg"
10840265|NCT00226941|EG002|Reported Event|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
11329269|NCT03441789|OG000|Outcome|Otezla Plus Enstilar Foam|"Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily~Enstilar: Enstilar foam applied to affected areas daily~Otezla: Otezla 30mg"
11329270|NCT03441789|OG001|Outcome|Otezla Plus Vehicle Foam|"Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily~Vehicle: vehicle foam applied to affected areas once daily~Otezla: Otezla 30mg"
11329271|NCT03441789|EG000|Reported Event|Otezla Plus Enstilar Foam|"Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily~Enstilar: Enstilar foam applied to affected areas daily~Otezla: Otezla 30mg"
11329272|NCT03441789|EG001|Reported Event|Otezla Plus Vehicle Foam|"Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily~Vehicle: vehicle foam applied to affected areas once daily~Otezla: Otezla 30mg"
11329273|NCT03441984|BG000|Baseline|All Study Participants in Part 1|All participants received either treatment A or B or C in 6 treatment sequences: ABC, BCA, CAB, ACB, CBA and BAC
11329274|NCT03441984|BG001|Baseline|All Study Participants in Part 2|All participants received either treatment D or E or F in 6 treatment sequences: DEF, EFD, FDE, DFE, EDF and FED
11329275|NCT03441984|BG002|Baseline|Total|Total of all reporting groups
11329276|NCT03441984|FG000|Participant Flow|Treatment Sequence ABC-Part 1|Participants received either treatment A=Adult TRIUMEQ (Dolutegravir [DTG] 50 milligram [mg]/Abacavir [ABC] 600 mg/Lamivudine [3TC] 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days after each treatment.
11329277|NCT03441984|FG001|Participant Flow|Treatment Sequence BCA-Part 1|Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth followed by a wash-out period of 7 days.
11329278|NCT03441984|FG002|Participant Flow|Treatment Sequence CAB-Part 1|Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.
11329279|NCT03441984|FG003|Participant Flow|Treatment Sequence ACB-Part 1|Participants received either treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion followed by a wash-out period of 7 days.
10840266|NCT00226941|EG003|Reported Event|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
11329280|NCT03441984|FG004|Participant Flow|Treatment Sequence BAC-Part 1|Participants received either treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, one tablet) direct-to-mouth or treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth followed by a wash-out period of 7 days.
11329281|NCT03441984|FG005|Participant Flow|Treatment Sequence CBA-Part 1|Participants received either treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) direct-to-mouth or treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) as a dispersion or treatment A=Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg. one tablet) direct-to-mouth followed by a wash-out period of 7 days.
11329282|NCT03441984|FG006|Participant Flow|Treatment DEF-Part 2|Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.
11329283|NCT03441984|FG007|Participant Flow|Treatment EFD-Part 2|Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg as one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.
11329284|NCT03441984|FG008|Participant Flow|Treatment FDE-Part 2|Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, as 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.
11329285|NCT03441984|FG009|Participant Flow|Treatment DFE-Part 2|Participants received either treatment D=Adult DTG 50 mg and 3TC 300 mg, as one conventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion followed by a wash-out period of 7 days.
11329286|NCT03441984|FG010|Participant Flow|Treatment EDF-Part 2|Participants received either treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one coventional tablet direct-to-mouth or treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth followed by a wash-out period of 7 days.
11329287|NCT03441984|FG011|Participant Flow|Treatment FED-Part 2|Participants received either treatment F=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets direct-to-mouth or treatment E=Pediatric DTG 5 mg/3TC 30 mg, 10 dispersible tablets as dispersion or treatment D=Adult DTG 50 mg and 3TC 300 mg, one conventional tablet direct-to-mouth followed by a wash-out period of 7 days.
11329288|NCT03441984|OG000|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet|Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
11329289|NCT03441984|OG001|Outcome|DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets|Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
11329290|NCT03441984|OG002|Outcome|DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth|Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
11329291|NCT03441984|OG000|Outcome|DTG 50 mg/3TC 300 mg Tablet|Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
11329292|NCT03441984|OG001|Outcome|DTG 5 mg/3TC 30 mg Dispersible Tablet|Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
11329293|NCT03441984|OG002|Outcome|DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth|Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
11329294|NCT03441984|OG002|Outcome|DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth|Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
11329295|NCT03441984|EG000|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet-Part 1|Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth.
11329296|NCT03441984|EG001|Reported Event|DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets-Part 1|Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately.
11329297|NCT03441984|EG002|Reported Event|DTG5mg/ABC60mg/3TC30mgdispersible Tablet Direct to Mouth-Part1|Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth.
11329298|NCT03441984|EG003|Reported Event|DTG 50 mg/3TC 300 mg Tablet-Part 2|Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth
11329299|NCT03441984|EG004|Reported Event|DTG 5 mg/3TC 30 mg Dispersible Tablet-Part 2|Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion
11329300|NCT03441984|EG005|Reported Event|DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth-Part 2|Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth
11329301|NCT03442036|BG000|Baseline|Through-the-Needle Technique|"Perineural catheters are inserted through a straight hollow-bore needle.~The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.~Through-the-Needle Technique: Perineural catheters are inserted through a straight hollow-bore needle"
11329302|NCT03442036|BG001|Baseline|Suture-Method Technique|"Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.~The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.~Suture-Method Technique: Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve"
11329303|NCT03442036|BG002|Baseline|Total|Total of all reporting groups
11329304|NCT03442036|FG000|Participant Flow|Through-the-Needle Technique|"Perineural catheters were inserted through a straight hollow-bore needle.~The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control."
11336213|NCT03563183|OG003|Outcome|Pre-Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as pre-frail.
11329305|NCT03442036|FG001|Participant Flow|Suture-Method Technique|"Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.~The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control."
11329306|NCT03442036|OG000|Outcome|Through-the-Needle Technique|"Perineural catheters were inserted through a straight hollow-bore needle.~The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control."
11329307|NCT03442036|OG001|Outcome|Suture-Method Technique|"Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.~The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control."
11329308|NCT03442036|OG000|Outcome|Through-the-Needle Technique|"Perineural catheters are inserted through a straight hollow-bore needle.~The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.~Through-the-Needle Technique: Perineural catheters are inserted through a straight hollow-bore needle"
11329309|NCT03442036|OG001|Outcome|Suture-Method Technique|"Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.~The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.~Suture-Method Technique: Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve"
11329310|NCT03442036|EG000|Reported Event|Through-the-Needle Technique|19 Gauge Perineural catheter inserted via a 17 Gauge Touhy Neede
11329311|NCT03442036|EG001|Reported Event|Suture-Catheter|19 Gauge Perineural catheter via 19 G Suture needle
11329312|NCT03442296|BG000|Baseline|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329313|NCT03442296|BG001|Baseline|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329314|NCT03442296|BG002|Baseline|Total|Total of all reporting groups
11329315|NCT03442296|FG000|Participant Flow|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329316|NCT03442296|FG001|Participant Flow|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329317|NCT03442296|OG000|Outcome|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329318|NCT03442296|OG001|Outcome|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329319|NCT03442296|EG000|Reported Event|Immediate Treatment Group|"Immediate treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329320|NCT03442296|EG001|Reported Event|Delayed Treatment Group|"3-month delayed treatment with Baltimore HEARS intervention~Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)~Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation."
11329321|NCT03442569|BG000|Baseline|Open-label, Single Arm, Phase II|"Nivolumab and ipilimumab with panitumumab~Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab~Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab~Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab"
11329322|NCT03442569|FG000|Participant Flow|Open-label, Single Arm, Phase II|"Nivolumab and ipilimumab with panitumumab~Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab~Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab~Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab"
11329323|NCT03442569|OG000|Outcome|Open-label, Single Arm, Phase II|"Nivolumab and ipilimumab with panitumumab~Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab~Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab~Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab"
11329324|NCT03442569|EG000|Reported Event|Open-label, Single Arm, Phase II|"Nivolumab and ipilimumab with panitumumab~Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab~Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab~Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab"
11329325|NCT03442595|BG000|Baseline|Cases|"Adult patients with uncontrolled type 2 diabetes mellitus and A1C>/= 9% that participate in the MedStar Diabetes Pathway~Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks."
11329326|NCT03442595|BG001|Baseline|Concurrent Matched Controls|Adult patients with uncontrolled type 2 diabetes and A1C>/=9% that propensity match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
10840267|NCT00227019|BG000|Baseline|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
11329327|NCT03442595|BG002|Baseline|Total|Total of all reporting groups
10840268|NCT00227019|FG000|Participant Flow|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
10840269|NCT00227019|OG000|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
10848198|NCT00289107|FG001|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10848199|NCT00289107|OG000|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10840270|NCT00227019|OG000|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
10848200|NCT00289107|OG001|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
11336214|NCT03563183|OG004|Outcome|Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as frail.
11336215|NCT03563183|OG005|Outcome|Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as frail.
11336216|NCT03563183|OG006|Outcome|Unknown-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were not assigned a frailty category.
11336217|NCT03563183|OG007|Outcome|Unknown-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were not assigned a frailty category.
11336218|NCT03563183|EG000|Reported Event|Non-Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as non-frail.
11336219|NCT03563183|EG001|Reported Event|Non-Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as non-frail.
11336220|NCT03563183|EG002|Reported Event|Pre-Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as pre-frail.
11336221|NCT03563183|EG003|Reported Event|Pre-Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as pre-frail.
11336222|NCT03563183|EG004|Reported Event|Frail-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were categorized as frail.
11336223|NCT03563183|EG005|Reported Event|Frail-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were categorized as frail.
11336224|NCT03563183|EG006|Reported Event|Unknown-HZ/su|Adults aged ≥50 years of age who received HZ/su vaccine (in Zoster-006/022 study) and were not assigned a frailty category.
11336225|NCT03563183|EG007|Reported Event|Unknown-Placebo|Adults aged ≥50 years of age who received placebo (in Zoster-006/022 study) and were not assigned a frailty category.
11336226|NCT03563209|BG000|Baseline|Post-stroke Elbow Flexor Spasticity|Participants with post-stroke elbow flexor spasticity
11336227|NCT03563209|FG000|Participant Flow|Post-stroke Elbow Flexor Spasticity|Participants with post-stroke elbow flexor spasticity
11336228|NCT03563209|OG000|Outcome|Spasticity Angle in Pronation|First group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the pronation position of forearm
11336229|NCT03563209|OG001|Outcome|Spasticity Angle in Neutral Position|Second group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the neutral position of forearm
11336230|NCT03563209|OG002|Outcome|Spasticity Angle in Supination|Third group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the supination position of forearm
11336231|NCT03563209|EG000|Reported Event|Post-stroke Elbow Flexor Spasticity|Participants with post-stroke elbow flexor spasticity
11336232|NCT03563313|BG000|Baseline|Closed Loop Control (CLC)|"Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months.~t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home."
11336233|NCT03563313|BG001|Baseline|Sensor-Augmented Pump (SAP)|"Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.~Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology."
11336234|NCT03563313|BG002|Baseline|Total|Total of all reporting groups
11336235|NCT03563313|FG000|Participant Flow|Closed Loop Control (CLC)|"Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months.~t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home."
11336236|NCT03563313|FG001|Participant Flow|Sensor-Augmented Pump (SAP)|"Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.~Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology."
11336237|NCT03563313|OG000|Outcome|Closed Loop Control (CLC)|"Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months.~t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home."
11336238|NCT03563313|OG001|Outcome|Sensor-Augmented Pump (SAP)|"Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.~Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology."
11336239|NCT03563313|OG000|Outcome|Closed Loop Control (CLC) in Adults|"Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months.~t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home."
11336240|NCT03563313|OG001|Outcome|Sensor-Augmented Pump (SAP) in Adults|"Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.~Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology."
11336241|NCT03563313|OG002|Outcome|CLC in Teens|Survey response from a teen in CLC (14-18 years old)
11336242|NCT03563313|OG003|Outcome|SAP in Teens|Survey response from a Teen in the SAP group (ages 14-18).
11336243|NCT03563313|OG004|Outcome|Parent of Teen in CLC|Survey response from a parent of a teen in CLC
11336244|NCT03563313|OG005|Outcome|Parent of a Teen in SAP|Survey response from a parent of a teen in SAP
11336245|NCT03563313|EG000|Reported Event|Closed Loop Control (CLC)|"Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months.~t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home."
11336246|NCT03563313|EG001|Reported Event|Sensor-Augmented Pump (SAP)|"Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.~Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology."
11336247|NCT03564444|BG000|Baseline|Placebo|Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
11336248|NCT03564444|BG001|Baseline|Bivalent Vaccine|Participants received a single dose of bivalent vaccine by intranasal spray.
11336249|NCT03564444|BG002|Baseline|Total|Total of all reporting groups
11336250|NCT03564444|FG000|Participant Flow|Placebo|Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
11336251|NCT03564444|FG001|Participant Flow|Bivalent Vaccine|Participants received a single dose of bivalent vaccine by intranasal spray.
11336252|NCT03564444|OG000|Outcome|Placebo|Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
11336253|NCT03564444|OG001|Outcome|Bivalent Vaccine|Participants received a single dose of bivalent vaccine by intranasal spray.
11336254|NCT03564444|EG000|Reported Event|Placebo|Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
11336255|NCT03564444|EG001|Reported Event|Bivalent Vaccine|Participants received a single dose of bivalent vaccine by intranasal spray.
11336256|NCT03564886|BG000|Baseline|Hyperosmolar Saline|"The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.~Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR."
11336257|NCT03564886|BG001|Baseline|Normal Saline|"Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.~Normal saline: Lactate Ringer's (LR, 273mOsm/L)"
11336258|NCT03564886|BG002|Baseline|Total|Total of all reporting groups
11336259|NCT03564886|FG000|Participant Flow|Hyperosmolar Saline|"The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.~Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR."
11336260|NCT03564886|FG001|Participant Flow|Normal Saline|"Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.~Normal saline: Lactate Ringer's (LR, 273mOsm/L)"
11336261|NCT03564886|OG000|Outcome|Hyperosmolar Saline|"The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.~Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR."
11336262|NCT03564886|OG001|Outcome|Normal Saline|"Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.~Normal saline: Lactate Ringer's (LR, 273mOsm/L)"
11336263|NCT03564886|EG000|Reported Event|Hyperosmolar Saline|"The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.~Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR."
11336264|NCT03564886|EG001|Reported Event|Normal Saline|"Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.~Normal saline: Lactate Ringer's (LR, 273mOsm/L)"
11336265|NCT03565068|BG000|Baseline|Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg|Healthy participants received MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11336266|NCT03565068|BG001|Baseline|Panel A (Healthy Participants): Placebo Monotherapy|Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
11336267|NCT03565068|BG002|Baseline|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11336268|NCT03565068|BG003|Baseline|Panel B (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
11336269|NCT03565068|BG004|Baseline|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg|In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11336270|NCT03565068|BG005|Baseline|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-8 mg|In addition to background AAP treatment, participant with Schizophrenia received modified regimen of MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 8 mg, as follows: Days 1-3: 4 mg, Days 4-11: 8 mg.
11336271|NCT03565068|BG006|Baseline|Panel C (Schizophrenia Participants): Placebo Add-on Therapy|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18.
10840271|NCT00227019|EG000|Reported Event|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
10848201|NCT00289107|EG000|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
10848202|NCT00289107|EG001|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
10840272|NCT00227266|BG000|Baseline|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
10848574|NCT00290498|FG000|Participant Flow|R-HCVAD-MA|I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg & vincristine 1.4mg - 2mg, & oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg & 800mg 22h, & cytarabine 3g.
10848575|NCT00290498|FG001|Participant Flow|R-CHOP|R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
10848576|NCT00290498|OG000|Outcome|R-HCVAD|I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg & vincristine 1.4mg - 2mg, & oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg & 800mg 22h, & cytarabine 3g.
10848577|NCT00290498|OG001|Outcome|R-CHOP|R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
10848578|NCT00290498|OG000|Outcome|R-HCVAD/MA|I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg & vincristine 1.4mg - 2mg, & oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg & 800mg 22h, & cytarabine 3g.
11329328|NCT03442595|FG000|Participant Flow|Cases|"patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway~Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks."
11329329|NCT03442595|FG001|Participant Flow|Matched Controls|patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
11329330|NCT03442595|OG000|Outcome|Cases|"patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway~Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks."
11329331|NCT03442595|OG001|Outcome|Matched Controls|patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
11329332|NCT03442595|EG000|Reported Event|Cases|"patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway~Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks."
11329333|NCT03442699|BG000|Baseline|Cognitive Behavioral Therapy|"Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.~Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day."
11329334|NCT03442699|FG000|Participant Flow|Cognitive Behavioral Therapy|"Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.~Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day."
11329335|NCT03442699|OG000|Outcome|Pre Cognitive Behavioral Therapy|"Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.~Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day."
11329336|NCT03442699|OG001|Outcome|Post Cognitive Behavioral Therapy|"Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.~Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day."
11329337|NCT03442699|OG002|Outcome|3 Month Follow-up|"Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.~Cognitive Behavioral Therapy: Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day."
11329338|NCT03442699|EG000|Reported Event|Cognitive-Behavioral Therapy|All participants received cognitive-behavioral therapy
11329339|NCT03442725|BG000|Baseline|Healthy Subjects (Control Group)|Subjects with normal renal function (eGFR ≥90 mL/min/1.73 m²) received a single oral dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329340|NCT03442725|BG001|Baseline|Severe Renal Impairment (Test Group)|Subjects with severely decreased renal function (eGFR <30 mL/min/1.73 m², not requiring dialysis) received a single oral dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329341|NCT03442725|BG002|Baseline|Total|Total of all reporting groups
11329342|NCT03442725|FG000|Participant Flow|Healthy Subjects (Control Group)|Subjects with normal renal function (estimated glomerular filtration rate [eGFR] ≥90 millilitres/minute/1.73 metres squared [mL/min/1.73 m²]) received a single oral dose of 250 milligrams (mg) telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329343|NCT03442725|FG001|Participant Flow|Severe Renal Impairment (Test Group)|Subjects with severely decreased renal function (eGFR <30 mL/min/1.73 m², not requiring dialysis) received a single oral dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329344|NCT03442725|OG000|Outcome|Healthy Subjects (Control Group)|Subjects with normal renal function (eGFR ≥90 mL/min/1.73 m²) received a single oral dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329345|NCT03442725|OG001|Outcome|Severe Renal Impairment (Test Group)|Subjects with severely decreased renal function (eGFR <30 mL/min/1.73 m², not requiring dialysis) received a single oral dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329346|NCT03442725|EG000|Reported Event|Healthy Subjects (Control Group)|Subjects with normal renal function (eGFR ≥90 mL/min/1.73 m²) received a single dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11329347|NCT03442725|EG001|Reported Event|Severe Renal Impairment (Test Group)|Subjects with severely decreased renal function (eGFR <30 mL/min/1.73 m², not requiring dialysis) received a single dose of 250 mg telotristat etiprate given under fed conditions (between 15 minutes before and 1 hour after the meal or snack) on Day 1.
11335739|NCT03555435|OG001|Outcome|Peer Support|Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
11335740|NCT03555435|OG002|Outcome|Wait|Wait: Participants in this group will wait 6 weeks.
10840273|NCT00227266|BG001|Baseline|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840274|NCT00227266|BG002|Baseline|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840275|NCT00227266|BG003|Baseline|Total|Total of all reporting groups
10840276|NCT00227266|FG000|Participant Flow|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
10840277|NCT00227266|FG001|Participant Flow|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840278|NCT00227266|FG002|Participant Flow|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840279|NCT00227266|OG000|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
10840280|NCT00227266|OG001|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840281|NCT00227266|OG002|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840282|NCT00227266|OG000|Outcome|Cohort 2 Experimental|"Patients in cohort 2 (SMA standers and walkers) will receive VPA + Carnitine treatment for the entire 12 month time period."
10840283|NCT00227266|OG000|Outcome|Cohort 1a Sitters Placebo Then Treatment|
10840284|NCT00227266|OG001|Outcome|Cohort 1b Sitters Treatment|
10840285|NCT00227266|EG000|Reported Event|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
10840286|NCT00227266|EG001|Reported Event|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840287|NCT00227266|EG002|Reported Event|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
10840288|NCT00227305|BG000|Baseline|Quetiapine|Quetiapine 400mg/day to 800mg/day
10840289|NCT00227305|FG000|Participant Flow|Quetiapine|Quetiapine 400mg/day to 800mg/day
10840290|NCT00227305|OG000|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
10840291|NCT00227305|EG000|Reported Event|Quetiapine|Quetiapine 400mg/day to 800mg/day
10840292|NCT00227344|BG000|Baseline|Catheter Ablation|Catheter Ablation
10840293|NCT00227344|BG001|Baseline|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
10840294|NCT00227344|BG002|Baseline|Total|Total of all reporting groups
10840295|NCT00227344|FG000|Participant Flow|Catheter Ablation|Catheter Ablation
10840296|NCT00227344|FG001|Participant Flow|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
10840297|NCT00227344|OG000|Outcome|Catheter Ablation|Catheter Ablation
10840298|NCT00227344|OG001|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
10840299|NCT00227344|EG000|Reported Event|Catheter Ablation|Catheter Ablation
10840300|NCT00227344|EG001|Reported Event|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
10840301|NCT00227370|BG000|Baseline|Placebo Group|Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis
10840302|NCT00227370|BG001|Baseline|Treatment Group|Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.
10840303|NCT00227370|BG002|Baseline|Total|Total of all reporting groups
10840304|NCT00227370|FG000|Participant Flow|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.
10840305|NCT00227370|FG001|Participant Flow|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
10840306|NCT00227370|OG000|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
10840307|NCT00227370|OG001|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
10840308|NCT00227370|EG000|Reported Event|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
10840309|NCT00227370|EG001|Reported Event|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
10840310|NCT00227539|BG000|Baseline|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
10840311|NCT00227539|FG000|Participant Flow|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
10840312|NCT00227539|OG000|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
10840313|NCT00227539|EG000|Reported Event|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
10840314|NCT00227591|BG000|Baseline|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
10840315|NCT00227591|FG000|Participant Flow|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
10840316|NCT00227591|OG000|Outcome|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
10840317|NCT00227591|EG000|Reported Event|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
10840318|NCT00227617|BG000|Baseline|Combined Neuroendocrine Tumors|Patients with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, and Poorly Differentiated Neuroendocrine Carcinoma enrolled on the protocol
10840319|NCT00227617|FG000|Participant Flow|Carcinoid|"Starting on Day 1, administered every two weeks:~Leucovorin: 200 mg/ m2; over 2 hours~Oxaliplatin : 85 mg/m2; over 2 hours~followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours~Bevacizumab: 5 mg/kg IV~5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:~3 in carcinoid~10 in PNET"
10840320|NCT00227617|FG001|Participant Flow|PNET|"Starting on Day 1, administered every two weeks:~Leucovorin: 200 mg/ m2; over 2 hours~Oxaliplatin : 85 mg/m2; over 2 hours~followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours~Bevacizumab: 5 mg/kg IV~5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:~3 in carcinoid~10 in PNET"
10840321|NCT00227617|FG002|Participant Flow|Poorly Differentiated Neuroendocrine Carcinomas (PDNEC)|"Starting on Day 1, administered every two weeks:~Leucovorin: 200 mg/ m2; over 2 hours~Oxaliplatin : 85 mg/m2; over 2 hours~followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours~Bevacizumab: 5 mg/kg IV~5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:~3 in carcinoid~10 in PNET"
10840322|NCT00227617|OG000|Outcome|Carcinoid|"Starting on Day 1, administered every two weeks:~5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes~bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.~5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.~leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.~oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period"
10840323|NCT00227617|OG001|Outcome|PNET|"Starting on Day 1, administered every two weeks:~5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes~bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.~5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.~leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.~oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period"
10840324|NCT00227617|OG002|Outcome|PDNEC|"Starting on Day 1, administered every two weeks:~5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes~bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.~5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.~leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.~oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period"
10840325|NCT00227617|OG000|Outcome|Combined Neuroendocrine Tumors|Patients with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, Poorly Differentiated Neuroendocrine Carcinoma who received at least one treatment
10840326|NCT00227617|OG000|Outcome|Carcinoid|Carcinoid Neuroendocrine Tumors
10840327|NCT00227617|OG001|Outcome|PNET|Pancreatic Neuroendocrine Tumors
10840328|NCT00227617|OG002|Outcome|PDNEC|Poorly Differentiated Neuroendocrine carcinoma
10840329|NCT00227617|OG002|Outcome|PDNEC|Poorly differentiated neuroendocrine carcinoma (PDNEC)
10840330|NCT00227617|OG003|Outcome|All Neuroendocrine Tumors|
10840331|NCT00227617|EG000|Reported Event|Combined Neuroendocrine Tumors|Patients enrolled on protocol with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, or Poorly Differentiated Neuroendocrine Carcinoma whom received at least one treatment
10840332|NCT00227721|BG000|Baseline|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
10840333|NCT00227721|FG000|Participant Flow|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
10840334|NCT00227721|OG000|Outcome|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
10840335|NCT00227721|EG000|Reported Event|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
10840336|NCT00227760|BG000|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10840337|NCT00227760|FG000|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10840338|NCT00227760|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10840339|NCT00227760|EG000|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
10840340|NCT00227877|BG000|Baseline|Control - New England|"Control participants will receive care as usual from their provider"
10840341|NCT00227877|BG001|Baseline|Computer Screen & Brief Physician Advice - New England|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.~Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
10840342|NCT00227877|BG002|Baseline|Control - Czech Republic|"Control participants will receive care as usual from their provider"
10840343|NCT00227877|BG003|Baseline|Computer Screen & Brief Physician Advice - Czech Republic|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.~Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
10840344|NCT00227877|BG004|Baseline|Total|Total of all reporting groups
10840345|NCT00227877|FG000|Participant Flow|Control - New England|"Control participants received care as usual from their provider"
10840346|NCT00227877|FG001|Participant Flow|cSBA - New England|"Computer screen & brief physician advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested talking points which guided a discussion with the patient about drug and alcohol use."
10840347|NCT00227877|FG002|Participant Flow|Control - Czech Republic|"Control participants received care as usual from their provider"
10840348|NCT00227877|FG003|Participant Flow|cSBA - Czech Republic|"Computer screen & brief physician advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested talking points to guide a discussion with the patient about drug and alcohol use."
10840349|NCT00227877|OG000|Outcome|Control - New England, USA|"Control participants received care as usual from their providers"
10840350|NCT00227877|OG001|Outcome|Computer Screen & Brief Physician Advice - New England, USA|"Participants in the experimental arm completed the CRAFFT screen on the computer and received information on the computer regarding the health effects of substance use. Their providers were given the results of their CRAFFT screen and a list of suggested talking points which they used to guide a discussion with the patient about drug and alcohol use. Participants and their families also received educational brochures about substance use."
10840351|NCT00227877|OG000|Outcome|Control - New England, USA|"Control participants received care as usual from their provider"
10840352|NCT00227877|OG001|Outcome|cSBA - New England, USA|"Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested talking points which guided a discussion with the patient about drug and alcohol use."
10840353|NCT00227877|OG000|Outcome|Control - Prague, CZR|"Control participants received care as usual from their provider"
10840354|NCT00227877|OG001|Outcome|cSBA - Prague, CZR|"Computer Screen & Brief physician Advice: Participants in the experimental arm completed a computerized CRAFFT screen and received information on the computer regarding the health effects of substance use. Their provider was given the results of their CRAFFT screen and a list of suggested talking points which guided a discussion with the patient about drug and alcohol use."
10840355|NCT00227877|EG000|Reported Event|Control - New England|"Control participants will receive care as usual from their provider"
10840356|NCT00227877|EG001|Reported Event|Computer Screen & Brief Physician Advice - New England|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.~Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
10840357|NCT00227877|EG002|Reported Event|Control - Czech Republic|"Control participants will receive care as usual from their provider"
10840358|NCT00227877|EG003|Reported Event|Computer Screen & Brief Physician Advice - Czech Republic|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.~Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
10840359|NCT00227903|BG000|Baseline|Brief Advice|Advice and education
10840360|NCT00227903|BG001|Baseline|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
10840361|NCT00227903|BG002|Baseline|Total|Total of all reporting groups
10840362|NCT00227903|FG000|Participant Flow|Brief Advice|Advice and education
10840363|NCT00227903|FG001|Participant Flow|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
10840364|NCT00227903|OG000|Outcome|Brief Advice|Advice and education
10840365|NCT00227903|OG001|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
10840366|NCT00227903|EG000|Reported Event|Brief Advice|Advice and education
10840367|NCT00227903|EG001|Reported Event|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
10840368|NCT00227994|BG000|Baseline|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
10840369|NCT00227994|BG001|Baseline|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
10840370|NCT00227994|BG002|Baseline|Total|Total of all reporting groups
10840371|NCT00227994|FG000|Participant Flow|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
10840372|NCT00227994|FG001|Participant Flow|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
10840373|NCT00227994|OG000|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
10840374|NCT00227994|OG001|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
10840375|NCT00227994|EG000|Reported Event|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
10840376|NCT00227994|EG001|Reported Event|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
10840377|NCT00228384|BG000|Baseline|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
10840378|NCT00228384|BG001|Baseline|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
10840379|NCT00228384|BG002|Baseline|Total|Total of all reporting groups
10840380|NCT00228384|FG000|Participant Flow|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
10840381|NCT00228384|FG001|Participant Flow|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
10840382|NCT00228384|OG000|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
10840383|NCT00228384|OG001|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
10840384|NCT00228384|EG000|Reported Event|GORE VIABAHN Endoprosthesis|GORE VIABAHN Endoprosthesis
10840385|NCT00228384|EG001|Reported Event|Bare Nitinol Stent|Bare Nitinol Stent
10840386|NCT00228423|BG000|Baseline|75mg Clopidogrel|"75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel"
10840387|NCT00228423|BG001|Baseline|Placebo|"Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~water pill daily: Daily dose of water pill (placebo)"
10840388|NCT00228423|BG002|Baseline|Total|Total of all reporting groups
10840389|NCT00228423|FG000|Participant Flow|75mg Clopidogrel|"75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel"
10840390|NCT00228423|FG001|Participant Flow|Placebo|"Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~water pill daily: Daily dose of water pill (placebo)"
10840391|NCT00228423|OG000|Outcome|75mg Clopidogrel|"75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel"
10840392|NCT00228423|OG001|Outcome|Placebo|"Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~water pill daily: Daily dose of water pill (placebo)"
10840393|NCT00228423|EG000|Reported Event|75mg Clopidogrel|"75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel"
10840394|NCT00228423|EG001|Reported Event|Placebo|"Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.~water pill daily: Daily dose of water pill (placebo)"
10840395|NCT00228553|BG000|Baseline|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
10840396|NCT00228553|FG000|Participant Flow|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
10840397|NCT00228553|OG000|Outcome|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
10840398|NCT00228553|EG000|Reported Event|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
10840399|NCT00228566|BG000|Baseline|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
10840400|NCT00228566|FG000|Participant Flow|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
10840401|NCT00228566|OG000|Outcome|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
10840402|NCT00228566|EG000|Reported Event|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
10840403|NCT00228813|BG000|Baseline|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
10840404|NCT00228813|FG000|Participant Flow|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
10840405|NCT00228813|OG000|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
10840406|NCT00228813|EG000|Reported Event|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
10840407|NCT00228917|BG000|Baseline|ACAC_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
10840408|NCT00228917|BG001|Baseline|ACHibPS_Thailand Group|Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
11329348|NCT03442777|BG000|Baseline|Intervention Group 1 (on Top of Standard of Care)|"Allevyn® brand silicone adhesive multilayer foam dressings~Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand)."
10840409|NCT00228917|BG002|Baseline|HibACPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10840410|NCT00228917|BG003|Baseline|HibHibPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840411|NCT00228917|BG004|Baseline|ACAC_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
10840412|NCT00228917|BG005|Baseline|ACHibPS_Philippines Group|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840413|NCT00228917|BG006|Baseline|HibACPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840414|NCT00228917|BG007|Baseline|HibHibPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840415|NCT00228917|BG008|Baseline|Total|Total of all reporting groups
10840416|NCT00228917|FG000|Participant Flow|ACAC_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
10840417|NCT00228917|FG001|Participant Flow|ACHibPS_Thailand Group|Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10840418|NCT00228917|FG002|Participant Flow|HibACPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10840419|NCT00228917|FG003|Participant Flow|HibHibPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840420|NCT00228917|FG004|Participant Flow|ACAC_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
11335741|NCT03555435|EG000|Reported Event|On Your Own|Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.
10840421|NCT00228917|FG005|Participant Flow|ACHibPS_Philippines Group|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840422|NCT00228917|FG006|Participant Flow|HibACPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
11335742|NCT03555435|EG001|Reported Event|Peer Support|Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
10840423|NCT00228917|FG007|Participant Flow|HibHibPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840424|NCT00228917|OG000|Outcome|ACAC_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
10840425|NCT00228917|OG001|Outcome|ACHibPS_Thailand Group|Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10840426|NCT00228917|OG002|Outcome|HibACPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
10840427|NCT00228917|OG003|Outcome|HibHibPS_Thailand Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840428|NCT00228917|OG004|Outcome|ACAC_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
10840429|NCT00228917|OG005|Outcome|ACHibPS_Philippines Group|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840430|NCT00228917|OG006|Outcome|HibACPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840431|NCT00228917|OG007|Outcome|HibHibPS_Philippines Group|Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
10840432|NCT00228917|EG000|Reported Event|ACAC Group|Subjects from both ACAC_Thailand and ACAC_Philippines groups
10840433|NCT00228917|EG001|Reported Event|ACHibPS Group|Subjects from both ACHibPS_Thailand and ACHibPS_Philippines groups
10840434|NCT00228917|EG002|Reported Event|HibACPS Group|Subjects from both HibACPS_Thailand and HibACPS_Philippines groups
10840435|NCT00228917|EG003|Reported Event|HibHibPS Group|Subjects from both HibHibPS _Thailand and HibHibPS _Philippines groups
10840436|NCT00228943|BG000|Baseline|Entire Sample|"Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.~The final analysis combined groups to compare full strength versus control."
10840437|NCT00228943|FG000|Participant Flow|Full Strength Acute Tryptophan Depletion and Control|Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
10840438|NCT00228943|OG000|Outcome|Full Strength Acute Tryptophan Depletion|
10840439|NCT00228943|OG001|Outcome|Half-Strength Tryptophan Depletion - Control|
10840440|NCT00228943|EG000|Reported Event|Full Strength Acute Tryptophan Depletion|No adverse events
10840441|NCT00228943|EG001|Reported Event|Half-Strength Tryptophan Depletion - Control|No adverse events
10840442|NCT00229203|BG000|Baseline|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
10840443|NCT00229203|BG001|Baseline|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
10840444|NCT00229203|BG002|Baseline|Total|Total of all reporting groups
10840445|NCT00229203|FG000|Participant Flow|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
11335743|NCT03555435|EG002|Reported Event|Wait|Wait: Participants in this group will wait 6 weeks.
10840446|NCT00229203|FG001|Participant Flow|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
10840447|NCT00229203|OG000|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
10840448|NCT00229203|OG001|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
10840449|NCT00229203|EG000|Reported Event|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
10840450|NCT00229203|EG001|Reported Event|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
10840451|NCT00229619|BG000|Baseline|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
10840452|NCT00229619|FG000|Participant Flow|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
10840453|NCT00229619|OG000|Outcome|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
10840454|NCT00229619|OG000|Outcome|Rituximab (Rituxan)|"This is a non-randomized, off label, pilot study of humanized anti CD20 rituximab (Rituxan®) in patients with moderate aplastic anemia, pure red cell aplasia or Diamond-Blackfan anemia who have either failed to respond to at least one prior course of immunosuppressive therapy (PRCA/DBA patients only)or who have relapsed disease after prior immunosuppressive therapy (PRCA/DBA patients only).~Rituximab: Rituximab (Rituxan) 375mg/m2 intravenous infusion. The infusion will be once every week for a total of 4 doses."
10840455|NCT00229619|OG000|Outcome|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
10840456|NCT00229619|EG000|Reported Event|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
10840457|NCT00229658|BG000|Baseline|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
10840458|NCT00229658|BG001|Baseline|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
10840459|NCT00229658|BG002|Baseline|Total|Total of all reporting groups
10840460|NCT00229658|FG000|Participant Flow|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
10840461|NCT00229658|FG001|Participant Flow|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
10840462|NCT00229658|OG000|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
10840463|NCT00229658|OG001|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
10840464|NCT00229658|EG000|Reported Event|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
10840465|NCT00229658|EG001|Reported Event|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
10840466|NCT00229723|BG000|Baseline|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840467|NCT00229723|BG001|Baseline|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840468|NCT00229723|BG002|Baseline|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840469|NCT00229723|BG003|Baseline|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840470|NCT00229723|BG004|Baseline|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840471|NCT00229723|BG005|Baseline|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840472|NCT00229723|BG006|Baseline|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840473|NCT00229723|BG007|Baseline|Total|Total of all reporting groups
10840474|NCT00229723|FG000|Participant Flow|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840475|NCT00229723|FG001|Participant Flow|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840476|NCT00229723|FG002|Participant Flow|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840477|NCT00229723|FG003|Participant Flow|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840478|NCT00229723|FG004|Participant Flow|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840479|NCT00229723|FG005|Participant Flow|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840480|NCT00229723|FG006|Participant Flow|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840481|NCT00229723|OG000|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840482|NCT00229723|OG001|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840483|NCT00229723|OG002|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840484|NCT00229723|OG003|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840485|NCT00229723|OG004|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840486|NCT00229723|OG005|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840487|NCT00229723|OG006|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840488|NCT00229723|EG000|Reported Event|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840489|NCT00229723|EG001|Reported Event|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840490|NCT00229723|EG002|Reported Event|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
10840491|NCT00229723|EG003|Reported Event|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840492|NCT00229723|EG004|Reported Event|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840493|NCT00229723|EG005|Reported Event|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
10840494|NCT00229723|EG006|Reported Event|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
10840495|NCT00229957|BG000|Baseline|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
10840496|NCT00229957|BG001|Baseline|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
10840497|NCT00229957|BG002|Baseline|Total|Total of all reporting groups
10840498|NCT00229957|FG000|Participant Flow|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
10840499|NCT00229957|FG001|Participant Flow|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
10840500|NCT00229957|OG000|Outcome|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
10840501|NCT00229957|OG001|Outcome|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
10840502|NCT00229957|EG000|Reported Event|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
10840503|NCT00229957|EG001|Reported Event|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
10840504|NCT00230009|BG000|Baseline|Assessment Only|
10840505|NCT00230009|BG001|Baseline|Brief Intervention Session|
10840506|NCT00230009|BG002|Baseline|Total|Total of all reporting groups
10840507|NCT00230009|FG000|Participant Flow|Assessment Only|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.
10840508|NCT00230009|FG001|Participant Flow|Brief Intervention Session|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
10840509|NCT00230009|OG000|Outcome|Assessment Only|
10840510|NCT00230009|OG001|Outcome|Brief Intervention Session|
10840511|NCT00230009|EG000|Reported Event|Assessment Only|
10840512|NCT00230009|EG001|Reported Event|Brief Intervention Session|
10840513|NCT00230022|BG000|Baseline|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
10840514|NCT00230022|BG001|Baseline|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
10840515|NCT00230022|BG002|Baseline|Total|Total of all reporting groups
10840516|NCT00230022|FG000|Participant Flow|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
10840517|NCT00230022|FG001|Participant Flow|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
10840518|NCT00230022|OG000|Outcome|Brief Computer-delivered Motivational Intervention|A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
10840519|NCT00230022|OG001|Outcome|Assessment Only|Only assessment measures with no subsequent intervention.
10840520|NCT00230022|EG000|Reported Event|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
10840521|NCT00230022|EG001|Reported Event|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
10840522|NCT00230048|BG000|Baseline|Assessment Only|This arm answered questions only, but received no intervention.
10840523|NCT00230048|BG001|Baseline|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
10840524|NCT00230048|BG002|Baseline|Total|Total of all reporting groups
10840525|NCT00230048|FG000|Participant Flow|Assessment Only|This arm answered questions only, but received no intervention.
10840526|NCT00230048|FG001|Participant Flow|Brief Intervention|Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
10840527|NCT00230048|OG000|Outcome|Assessment Only|Assessment only, via computer.
10840528|NCT00230048|OG001|Outcome|Brief Intervention|Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
10840529|NCT00230048|OG000|Outcome|Assessment Only|This arm answered questions only, but received no intervention.
10840530|NCT00230048|OG001|Outcome|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
10840531|NCT00230048|EG000|Reported Event|Assessment Only|This arm answered questions only, but received no intervention.
10840532|NCT00230048|EG001|Reported Event|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
10840533|NCT00230100|BG000|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
10840534|NCT00230100|BG001|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
10840535|NCT00230100|BG002|Baseline|Total|Total of all reporting groups
10840536|NCT00230100|FG000|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
10840537|NCT00230100|FG001|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
10840538|NCT00230100|OG000|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
10840539|NCT00230100|OG001|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
10840540|NCT00230100|EG000|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
11335744|NCT03555565|BG000|Baseline|Alogliptin and Metformin Hydrochloride|Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
10840541|NCT00230100|EG001|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance dependence; 3) increase patients' self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
10840542|NCT00230126|BG000|Baseline|Arm A: 150 mg/Day|"150 mg/day~erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840543|NCT00230126|BG001|Baseline|Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840544|NCT00230126|BG002|Baseline|Total|Total of all reporting groups
10840545|NCT00230126|FG000|Participant Flow|Arm A: Erlotinib 150 mg/Day|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840546|NCT00230126|FG001|Participant Flow|Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840547|NCT00230126|OG000|Outcome|Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840548|NCT00230126|OG001|Outcome|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840549|NCT00230126|OG000|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840550|NCT00230126|OG001|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840551|NCT00230126|EG000|Reported Event|Arm A: 150 mg/Day Cycles 1 - 3|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840552|NCT00230126|EG001|Reported Event|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
10840553|NCT00230178|BG000|Baseline|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
10840554|NCT00230178|BG001|Baseline|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
10840555|NCT00230178|BG002|Baseline|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
10840556|NCT00230178|BG003|Baseline|Total|Total of all reporting groups
10840557|NCT00230178|FG000|Participant Flow|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
10840558|NCT00230178|FG001|Participant Flow|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
10840559|NCT00230178|FG002|Participant Flow|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
10840560|NCT00230178|OG000|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
10840561|NCT00230178|OG001|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
10840562|NCT00230178|OG002|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
10840563|NCT00230178|EG000|Reported Event|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
10840564|NCT00230178|EG001|Reported Event|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
10840565|NCT00230178|EG002|Reported Event|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
10840566|NCT00230282|BG000|Baseline|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
10840567|NCT00230282|FG000|Participant Flow|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
10840568|NCT00230282|OG000|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
10840569|NCT00230282|EG000|Reported Event|Fludarabine, Cytoxan, Then Alemtuzumab|"Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.~Alemtuzumab: 3 to 30 mg, IV~Fludarabine: [(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid~Cytoxan: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide"
10840570|NCT00230737|BG000|Baseline|A: Low Dose|Melatonin 0.4 mg
10840571|NCT00230737|BG001|Baseline|B: High Dose|Melatonin 4.0 mg
10840572|NCT00230737|BG002|Baseline|C: Control|Placebo
10840573|NCT00230737|BG003|Baseline|Total|Total of all reporting groups
10840574|NCT00230737|FG000|Participant Flow|A: Low Dose|Melatonin 0.4 mg
10840575|NCT00230737|FG001|Participant Flow|B: High Dose|Melatonin 4.0 mg
10840576|NCT00230737|FG002|Participant Flow|C: Control|Placebo
10840577|NCT00230737|OG000|Outcome|A: Low Dose|Melatonin 0.4 mg
10840578|NCT00230737|OG001|Outcome|B: High Dose|Melatonin 4.0 mg
10840579|NCT00230737|OG002|Outcome|C: Control|Placebo
10840580|NCT00230737|EG000|Reported Event|A: Low Dose|Melatonin 0.4 mg
10840581|NCT00230737|EG001|Reported Event|B: High Dose|Melatonin 4.0 mg
10840582|NCT00230737|EG002|Reported Event|C: Control|Placebo
10840583|NCT00230802|BG000|Baseline|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
10840584|NCT00230802|BG001|Baseline|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
10840585|NCT00230802|BG002|Baseline|Total|Total of all reporting groups
10840586|NCT00230802|FG000|Participant Flow|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
10840587|NCT00230802|FG001|Participant Flow|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
10840588|NCT00230802|OG000|Outcome|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
10840589|NCT00230802|OG001|Outcome|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
10840590|NCT00230802|OG000|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
10840591|NCT00230802|OG001|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
10840592|NCT00230802|EG000|Reported Event|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
10840593|NCT00230802|EG001|Reported Event|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
10840594|NCT00230971|BG000|Baseline|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10840595|NCT00230971|BG001|Baseline|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
10840596|NCT00230971|BG002|Baseline|Total|Total of all reporting groups
10840597|NCT00230971|FG000|Participant Flow|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10840598|NCT00230971|FG001|Participant Flow|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
10840599|NCT00230971|OG000|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10840600|NCT00230971|OG001|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
10840601|NCT00230971|EG000|Reported Event|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
10840602|NCT00230971|EG001|Reported Event|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
10840603|NCT00231062|BG000|Baseline|Balloon Dilation of Sinus Ostia|
10840604|NCT00231062|FG000|Participant Flow|Balloon Dilation of Sinus Ostia|
10840605|NCT00231062|OG000|Outcome|Balloon Dilation of Sinus Ostia|
10840606|NCT00231062|EG000|Reported Event|Balloon Dilation of Sinus Ostia|
10840607|NCT00231114|BG000|Baseline|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840608|NCT00231114|BG001|Baseline|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840609|NCT00231114|BG002|Baseline|Total|Total of all reporting groups
10840610|NCT00231114|FG000|Participant Flow|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840611|NCT00231114|FG001|Participant Flow|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840612|NCT00231114|OG000|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840613|NCT00231114|OG001|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
10840614|NCT00231114|EG000|Reported Event|Alair (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
10840615|NCT00231114|EG001|Reported Event|Sham (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
10840616|NCT00231114|EG002|Reported Event|Alair (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
10840617|NCT00231114|EG003|Reported Event|Sham (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
10840618|NCT00231179|BG000|Baseline|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
10840619|NCT00231179|BG001|Baseline|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
10840620|NCT00231179|BG002|Baseline|Total|Total of all reporting groups
10840621|NCT00231179|FG000|Participant Flow|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
10840622|NCT00231179|FG001|Participant Flow|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
10840623|NCT00231179|OG000|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
10840624|NCT00231179|OG001|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
10840625|NCT00231179|EG000|Reported Event|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
10840626|NCT00231179|EG001|Reported Event|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
10840627|NCT00231283|BG000|Baseline|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
10840628|NCT00231283|FG000|Participant Flow|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
10840629|NCT00231283|OG000|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
10840630|NCT00231283|EG000|Reported Event|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
10840631|NCT00231309|BG000|Baseline|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
10840632|NCT00231309|FG000|Participant Flow|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
10840633|NCT00231309|OG000|Outcome|Granulocyte-stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
10840634|NCT00231309|OG000|Outcome|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
10840635|NCT00231309|EG000|Reported Event|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
10840636|NCT00231413|BG000|Baseline|HPV-16/18 Group|Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840637|NCT00231413|BG001|Baseline|HPV-TETRA A Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840638|NCT00231413|BG002|Baseline|HPV-TETRA B Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840639|NCT00231413|BG003|Baseline|HPV-TETRA C Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840640|NCT00231413|BG004|Baseline|HPV-TETRA D Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840641|NCT00231413|BG005|Baseline|HPV-TETRA E Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840642|NCT00231413|BG006|Baseline|HPV-TETRA F Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840643|NCT00231413|BG007|Baseline|Total|Total of all reporting groups
10840644|NCT00231413|FG000|Participant Flow|HPV-16/18 Group|Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840645|NCT00231413|FG001|Participant Flow|HPV-TETRA A Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840646|NCT00231413|FG002|Participant Flow|HPV-TETRA B Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840647|NCT00231413|FG003|Participant Flow|HPV-TETRA C Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840648|NCT00231413|FG004|Participant Flow|HPV-TETRA D Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840649|NCT00231413|FG005|Participant Flow|HPV-TETRA E Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840650|NCT00231413|FG006|Participant Flow|HPV-TETRA F Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840651|NCT00231413|OG000|Outcome|HPV-16/18 Group|Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840652|NCT00231413|OG001|Outcome|HPV-TETRA A Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840653|NCT00231413|OG002|Outcome|HPV-TETRA B Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840654|NCT00231413|OG003|Outcome|HPV-TETRA C Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840655|NCT00231413|OG004|Outcome|HPV-TETRA D Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840656|NCT00231413|OG005|Outcome|HPV-TETRA E Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840657|NCT00231413|OG006|Outcome|HPV-TETRA F Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840658|NCT00231413|EG000|Reported Event|HPV-16/18 Group|Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840659|NCT00231413|EG001|Reported Event|HPV-TETRA A Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840660|NCT00231413|EG002|Reported Event|HPV-TETRA B Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840661|NCT00231413|EG003|Reported Event|HPV-TETRA C Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840662|NCT00231413|EG004|Reported Event|HPV-TETRA D Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840663|NCT00231413|EG005|Reported Event|HPV-TETRA E Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840664|NCT00231413|EG006|Reported Event|HPV-TETRA F Group|Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
10840665|NCT00231465|BG000|Baseline|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
10840666|NCT00231465|FG000|Participant Flow|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
10840667|NCT00231465|OG000|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
10840668|NCT00231465|EG000|Reported Event|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
10840669|NCT00231478|BG000|Baseline|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
10840670|NCT00231478|BG001|Baseline|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
10840671|NCT00231478|BG002|Baseline|Total|Total of all reporting groups
10840672|NCT00231478|FG000|Participant Flow|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
10840673|NCT00231478|FG001|Participant Flow|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
10840674|NCT00231478|OG000|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
10840675|NCT00231478|OG001|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
10840676|NCT00231478|EG000|Reported Event|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
10840677|NCT00231478|EG001|Reported Event|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
10840678|NCT00231777|BG000|Baseline|MK0517 Intravenous (IV) 40 mg|"On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.~Data Reported is for all all participants who received active study therapy."
10840679|NCT00231777|BG001|Baseline|Ondansetron IV 4 mg|"On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.~The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.~Data Reported is for all all participants who received active study therapy."
10840680|NCT00231777|BG002|Baseline|Total|Total of all reporting groups
10840681|NCT00231777|FG000|Participant Flow|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
10840682|NCT00231777|FG001|Participant Flow|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
10840683|NCT00231777|OG000|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
10840684|NCT00231777|OG001|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
10840685|NCT00231777|EG000|Reported Event|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
10840686|NCT00231777|EG001|Reported Event|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
10840687|NCT00231816|BG000|Baseline|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
10840688|NCT00231816|BG001|Baseline|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
10840689|NCT00231816|BG002|Baseline|Total|Total of all reporting groups
10840690|NCT00231816|FG000|Participant Flow|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
10840691|NCT00231816|FG001|Participant Flow|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
10840692|NCT00231816|OG000|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
10840693|NCT00231816|OG001|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
10840694|NCT00231816|OG000|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL SC injection administered comcomitantly with 0.5 mL IM influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
10840695|NCT00231816|EG000|Reported Event|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
10840696|NCT00231816|EG001|Reported Event|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
10840697|NCT00231842|BG000|Baseline|Chemotherapy and Radiation Therapy|"Adjuvant Radiation Therapy Sandwiched between Ifosfamide in Patients with Mixed Mesodermal Tumors~Radiation Therapy : Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.~Ifosfamide : Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles."
10840698|NCT00231842|FG000|Participant Flow|Chemotherapy and Radiation Therapy|Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
10848203|NCT00289120|BG000|Baseline|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a 3-week wash out period before subjects enter phase 2 of the study.~Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
10840699|NCT00231842|OG000|Outcome|Grade 3 Toxicity|"Adjuvant Radiation Therapy Sandwiched between Ifosfamide in Patients with Mixed Mesodermal Tumors~Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.~Radiation Therapy: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles."
10840700|NCT00231842|OG001|Outcome|Grade 4 Toxicity|"Adjuvant Radiation Therapy Sandwiched between Ifosfamide in Patients with Mixed Mesodermal Tumors~Ifosfamide: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles."
10840701|NCT00231842|EG000|Reported Event|Chemotherapy and Radiation Therapy|"Adjuvant Radiation Therapy Sandwiched between Ifosfamide in Patients with Mixed Mesodermal Tumors~Radiation Therapy : Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.~Ifosfamide : Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles."
10840702|NCT00231868|BG000|Baseline|Drug:Carboplatin, Paclitaxel & Radiation|"Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy~Carboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles~Carboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles"
10840703|NCT00231868|FG000|Participant Flow|Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy|"Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy~Carboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles~Carboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles"
10840704|NCT00231868|OG000|Outcome|Drug:Carboplatin, Paclitaxel & Radiation|"Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy~Carboplatin and Paclitaxel and Pelvic Radiation Therapy: Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles~Carboplatin and Paclitaxel and Radiation Therapy: Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles"
10840705|NCT00231868|EG000|Reported Event|Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy|"Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy~Carboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles~Note: The original PI has left the institution, therefore Dr. Kuo inherited the study. Efforts were made to contact the PI/study team members to locate the raw data, but were unsuccessful. No AE data are available at this time."
10840706|NCT00231894|BG000|Baseline|Pioglitazone|pioglitazone
10840707|NCT00231894|BG001|Baseline|Placebo|placebo
10840708|NCT00231894|BG002|Baseline|Total|Total of all reporting groups
10840709|NCT00231894|FG000|Participant Flow|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
10840710|NCT00231894|FG001|Participant Flow|Placebo|Placebo capsules daily plus life-style diet education group
10840711|NCT00231894|OG000|Outcome|Pioglitazone|pioglitazone and life-style diet group
10840712|NCT00231894|OG001|Outcome|Placebo|placebo and life-style diet group
10840713|NCT00231894|OG000|Outcome|Piogltiazone|"pioglitazone and life-style diet group~Pioglitazone: pioglitazone 15-45 mg/day~Life style diet group: life style diet education group 1x/week"
10840714|NCT00231894|OG001|Outcome|Placebo|"placebo and life-style diet group~Life style diet group: life style diet education group 1x/week~placebo: placebo comparator"
10840715|NCT00231894|OG000|Outcome|Pioglitazone|pioglitazone
10840716|NCT00231894|OG001|Outcome|Placebo|placebo
10840717|NCT00231894|OG000|Outcome|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
10840718|NCT00231894|OG001|Outcome|Placebo|Placebo capsules daily plus life-style diet education group
10840719|NCT00231894|EG000|Reported Event|Pioglitazone|pioglitazone
10840720|NCT00231894|EG001|Reported Event|Placebo|placebo
10840721|NCT00232180|BG000|Baseline|Eplerenone|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
10840722|NCT00232180|BG001|Baseline|Placebo|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
10840723|NCT00232180|BG002|Baseline|Total|Total of all reporting groups
11335745|NCT03555565|FG000|Participant Flow|Alogliptin and Metformin Hydrochloride|Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
10840724|NCT00232180|FG000|Participant Flow|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
10840725|NCT00232180|FG001|Participant Flow|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
10840726|NCT00232180|FG002|Participant Flow|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
10840727|NCT00232180|OG000|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
10840728|NCT00232180|OG001|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
10840729|NCT00232180|EG000|Reported Event|Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
10840730|NCT00232180|EG001|Reported Event|Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
10840731|NCT00232180|EG002|Reported Event|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
10840732|NCT00232180|EG003|Reported Event|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
10840733|NCT00232180|EG004|Reported Event|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
10840734|NCT00232479|BG000|Baseline|Group 1|treat with taxotere, herceptin, carboplatin in dose dense fashion
10840735|NCT00232479|FG000|Participant Flow|Group 1|study group receives taxotere, herceptin and carboplatin in dose dense fashion
10840736|NCT00232479|OG000|Outcome|Group 1|patients received dose dense herceptin, carboplatin and taxotere
10840737|NCT00232479|OG000|Outcome|Group 1|patients received herceptin, carboplatin and taxotere in a dose dense fashion.
10840738|NCT00232479|EG000|Reported Event|Group 1|patients received herceptin, carboplatin, taxotere in dose dense fashion
10840739|NCT00232505|BG000|Baseline|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
10840740|NCT00232505|BG001|Baseline|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
10840741|NCT00232505|BG002|Baseline|Total|Total of all reporting groups
10840742|NCT00232505|FG000|Participant Flow|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
10840743|NCT00232505|FG001|Participant Flow|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
10840744|NCT00232505|OG000|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
10840745|NCT00232505|OG001|Outcome|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
10840746|NCT00232505|OG002|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
10840747|NCT00232505|OG003|Outcome|Cetuximab and Carboplatin Subset|patients receiving cetuximab and carboplatin who had confirmed basal-like disease by quantitative realtime polymerase chain reaction-based intrinsic subtype assay
10840748|NCT00232505|OG001|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
11335746|NCT03555565|OG000|Outcome|Alogliptin and Metformin Hydrochloride|Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
10840749|NCT00232505|EG000|Reported Event|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
10840750|NCT00232505|EG001|Reported Event|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
10840751|NCT00232505|EG002|Reported Event|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
10840752|NCT00232544|BG000|Baseline|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
10840753|NCT00232544|BG001|Baseline|TLC-Control|A TLC system for providing general health education
10840754|NCT00232544|BG002|Baseline|Total|Total of all reporting groups
10840755|NCT00232544|FG000|Participant Flow|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
10840756|NCT00232544|FG001|Participant Flow|TLC-Control|A TLC system for providing general health education
10840757|NCT00232544|OG000|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
10840758|NCT00232544|OG001|Outcome|TLC-Control|A TLC system for providing general health education
10840759|NCT00232544|EG000|Reported Event|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
10840760|NCT00232544|EG001|Reported Event|TLC-Control|A TLC system for providing general health education
10840761|NCT00232557|BG000|Baseline|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
10840762|NCT00232557|BG001|Baseline|TLC-health Education|A TLC system for providing general health education
10840763|NCT00232557|BG002|Baseline|Total|Total of all reporting groups
10840764|NCT00232557|FG000|Participant Flow|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
10840765|NCT00232557|FG001|Participant Flow|TLC-health Education|A TLC system for providing general health education
10840766|NCT00232557|OG000|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
10840767|NCT00232557|OG001|Outcome|TLC-health Education|A TLC system for providing general health education
10840768|NCT00232557|EG000|Reported Event|Arm 1|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
10840769|NCT00232557|EG001|Reported Event|Arm 2|A TLC system for providing general health education
10840770|NCT00232583|BG000|Baseline|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840771|NCT00232583|BG001|Baseline|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840772|NCT00232583|BG002|Baseline|Total|Total of all reporting groups
10840773|NCT00232583|FG000|Participant Flow|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840774|NCT00232583|FG001|Participant Flow|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840775|NCT00232583|OG000|Outcome|Metformin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840776|NCT00232583|OG001|Outcome|Metformin, GLyburide & Pioglitazone|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840777|NCT00232583|OG000|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840778|NCT00232583|OG001|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840779|NCT00232583|OG000|Outcome|Metfomin and Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840780|NCT00232583|OG001|Outcome|Metformin, Pioglitazone and Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840781|NCT00232583|EG000|Reported Event|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
10840782|NCT00232583|EG001|Reported Event|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
10840783|NCT00232596|BG000|Baseline|Placebo - Double-blind (DB) Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
10840784|NCT00232596|BG001|Baseline|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840785|NCT00232596|BG002|Baseline|Total|Total of all reporting groups
10840786|NCT00232596|FG000|Participant Flow|Placebo|Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
10840787|NCT00232596|FG001|Participant Flow|Retigabine|Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.
10840788|NCT00232596|OG000|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
10840789|NCT00232596|OG001|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840790|NCT00232596|OG000|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
10840791|NCT00232596|OG001|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840792|NCT00232596|OG001|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840793|NCT00232596|OG001|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840794|NCT00232596|OG000|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
10840795|NCT00232596|OG001|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
10840796|NCT00232596|OG002|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840797|NCT00232596|OG003|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
10840798|NCT00232596|OG002|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840799|NCT00232596|OG001|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840800|NCT00232596|EG000|Reported Event|Placebo - Double-blind (DB) Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
10840801|NCT00232596|EG001|Reported Event|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
10840802|NCT00232596|EG002|Reported Event|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
10840803|NCT00232596|EG003|Reported Event|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
10840804|NCT00232739|BG000|Baseline|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
10840805|NCT00232739|FG000|Participant Flow|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
10840806|NCT00232739|OG000|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
10840807|NCT00232739|EG000|Reported Event|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
10840808|NCT00233064|BG000|Baseline|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
10840809|NCT00233064|BG001|Baseline|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
10840810|NCT00233064|BG002|Baseline|Total|Total of all reporting groups
10840811|NCT00233064|FG000|Participant Flow|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
10840812|NCT00233064|FG001|Participant Flow|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
10840813|NCT00233064|OG000|Outcome|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
10840814|NCT00233064|OG001|Outcome|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
10840815|NCT00233064|OG002|Outcome|Combined Liquid/Lyophilized Palivizumab|
10840816|NCT00233064|EG000|Reported Event|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
10840817|NCT00233064|EG001|Reported Event|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
10840818|NCT00233103|BG000|Baseline|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
10840819|NCT00233103|BG001|Baseline|Placebo|Placebo for 10 weeks
10840820|NCT00233103|BG002|Baseline|Total|Total of all reporting groups
10840821|NCT00233103|FG000|Participant Flow|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
10840822|NCT00233103|FG001|Participant Flow|Placebo|Placebo for 10 weeks
10840823|NCT00233103|OG000|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
10840824|NCT00233103|OG001|Outcome|Placebo|Placebo for 10 weeks
10840825|NCT00233103|EG000|Reported Event|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
10840826|NCT00233103|EG001|Reported Event|Placebo|Placebo for 10 weeks
10840827|NCT00233324|BG000|Baseline|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)
10840828|NCT00233324|BG001|Baseline|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)
10840829|NCT00233324|BG002|Baseline|Early Surfactant and Lower Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
10840830|NCT00233324|BG003|Baseline|Early Surfactant and Higher Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
10840831|NCT00233324|BG004|Baseline|Total|Total of all reporting groups
10840832|NCT00233324|FG000|Participant Flow|Early Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
10840833|NCT00233324|FG001|Participant Flow|Early Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
10840834|NCT00233324|FG002|Participant Flow|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
10840835|NCT00233324|FG003|Participant Flow|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
10840836|NCT00233324|OG000|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
10840837|NCT00233324|OG001|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
10840838|NCT00233324|OG000|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
10840839|NCT00233324|OG001|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
10840840|NCT00233324|OG002|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
10840841|NCT00233324|OG003|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
10840842|NCT00233324|OG000|Outcome|Surfactant and Low Oxygen|Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
10840843|NCT00233324|OG001|Outcome|Surfactant and High Oxygen|Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
10840844|NCT00233324|OG002|Outcome|CPAP and Low Oxygen|Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
10840845|NCT00233324|OG003|Outcome|CPAP and High Oxygen|Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 91% to 95%
10840846|NCT00233324|OG003|Outcome|CPAP and High Oxygen|Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
10840847|NCT00233324|EG000|Reported Event|Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
10840848|NCT00233324|EG001|Reported Event|Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
10840849|NCT00233324|EG002|Reported Event|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
10840850|NCT00233324|EG003|Reported Event|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
10840851|NCT00233363|BG000|Baseline|Rebamipide|A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
10840852|NCT00233363|BG001|Baseline|Placebo|A placebo tablet was administered orally three times a day for eight weeks.
10840853|NCT00233363|BG002|Baseline|Total|Total of all reporting groups
10840854|NCT00233363|FG000|Participant Flow|Rebamipide|A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
10840855|NCT00233363|FG001|Participant Flow|Placebo|A placebo tablet was administered orally three times a day for eight weeks.
10840856|NCT00233363|OG000|Outcome|Rebamipide|A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
10840857|NCT00233363|OG001|Outcome|Placebo|A placebo tablet was administered orally three times a day for eight weeks.
10840858|NCT00233363|EG000|Reported Event|Rebamipide|A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
10840859|NCT00233363|EG001|Reported Event|Placebo|A placebo tablet was administered orally three times a day for eight weeks.
10840860|NCT00233389|BG000|Baseline|Rebamipide|Following 1 week of H. pylori eradication therapy, a rebamipide 100 mg tablet was administered orally three times a day for 7 weeks.
10840861|NCT00233389|BG001|Baseline|Placebo|Following 1 week of H. pylori eradication therapy, a placebo tablet was administered orally three times a day for 7 weeks.
10840862|NCT00233389|BG002|Baseline|Total|Total of all reporting groups
10840863|NCT00233389|FG000|Participant Flow|Rebamipide|Following 1 week of H. pylori eradication therapy, a rebamipide 100 mg tablet was administered orally three times a day for 7 weeks.
10840864|NCT00233389|FG001|Participant Flow|Placebo|Following 1 week of H. pylori eradication therapy, a placebo tablet was administered orally three times a day for 7 weeks.
10840865|NCT00233389|OG000|Outcome|Rebamipide|Following 1 week of H. pylori eradication therapy, a rebamipide 100 mg tablet was administered orally three times a day for 7 weeks.
10840866|NCT00233389|OG001|Outcome|Placebo|Following 1 week of H. pylori eradication therapy, a placebo tablet was administered orally three times a day for 7 weeks.
10840867|NCT00233389|EG000|Reported Event|Rebamipide|Following 1 week of H. pylori eradication therapy, a rebamipide 100 mg tablet was administered orally three times a day for 7 weeks.
10840868|NCT00233389|EG001|Reported Event|Placebo|Following 1 week of H. pylori eradication therapy, a placebo tablet was administered orally three times a day for 7 weeks.
10840869|NCT00233402|BG000|Baseline|Comparator|Standard White Light Cystoscopy
10840870|NCT00233402|BG001|Baseline|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
10840871|NCT00233402|BG002|Baseline|Total|Total of all reporting groups
10840872|NCT00233402|FG000|Participant Flow|Comparator|Standard White Light Cystoscopy
10840873|NCT00233402|FG001|Participant Flow|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
10840874|NCT00233402|OG000|Outcome|Hexvix Group|The primary endpoint was assessed from patients randomized to the Hexvix group only
10840875|NCT00233402|OG001|Outcome|White Light Group|
10840876|NCT00233402|OG000|Outcome|Hexvix Group|
10840877|NCT00233402|OG000|Outcome|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
10840878|NCT00233402|EG000|Reported Event|Comparator|Standard White Light Cystoscopy
10840879|NCT00233402|EG001|Reported Event|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
10840880|NCT00233454|BG000|Baseline|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
10840881|NCT00233454|FG000|Participant Flow|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
10840882|NCT00233454|OG000|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
10840883|NCT00233454|EG000|Reported Event|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
10840884|NCT00233480|BG000|Baseline|Active Treatment|atorvastatin 10mg QD x 3 months
10840885|NCT00233480|BG001|Baseline|Placebo|matched placebo QD x 3 months
10840886|NCT00233480|BG002|Baseline|Total|Total of all reporting groups
10840887|NCT00233480|FG000|Participant Flow|Active Treatment|atorvastatin 10mg QD x 3 months
10840888|NCT00233480|FG001|Participant Flow|Placebo|matched placebo QD x 3 months
10840889|NCT00233480|OG000|Outcome|Active Treatment|atorvastatin 10mg QD x 3 months
10840890|NCT00233480|OG001|Outcome|Placebo|matched placebo QD x 3 months
10840891|NCT00233480|OG000|Outcome|Active Treatment|atorvastatin 10mg daily for three months
10840892|NCT00233480|OG001|Outcome|Placebo|matched placebo daily for three months
10840893|NCT00233480|EG000|Reported Event|Active Treatment|atorvastatin 10mg QD x 3 months
10840894|NCT00233480|EG001|Reported Event|Placebo|matched placebo QD x 3 months
10840895|NCT00233519|BG000|Baseline|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
10840896|NCT00233519|BG001|Baseline|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
10840897|NCT00233519|BG002|Baseline|Total|Total of all reporting groups
10840898|NCT00233519|FG000|Participant Flow|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
10840899|NCT00233519|FG001|Participant Flow|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
10840900|NCT00233519|OG000|Outcome|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
10840901|NCT00233519|OG001|Outcome|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
10840902|NCT00233519|EG000|Reported Event|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
10840903|NCT00233519|EG001|Reported Event|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
10840904|NCT00233948|BG000|Baseline|Phase I|Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
10840905|NCT00233948|BG001|Baseline|Phase II|Oral Nelfinavir at 3000 mg bid
10840906|NCT00233948|BG002|Baseline|Total|Total of all reporting groups
10840907|NCT00233948|FG000|Participant Flow|Phase I: Dose Level 1|Oral Nelfinavir at 1250mg bid.
10840908|NCT00233948|FG001|Participant Flow|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
10840909|NCT00233948|FG002|Participant Flow|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
10840910|NCT00233948|FG003|Participant Flow|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
10840911|NCT00233948|FG004|Participant Flow|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
10840912|NCT00233948|FG005|Participant Flow|Phase II|Oral Nelfinavir at 3000mg bid
10840913|NCT00233948|OG000|Outcome|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
10840914|NCT00233948|OG001|Outcome|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
10840915|NCT00233948|OG002|Outcome|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
10840916|NCT00233948|OG003|Outcome|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
10840917|NCT00233948|OG004|Outcome|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
10840918|NCT00233948|OG000|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
10840919|NCT00233948|OG000|Outcome|Phase II|Oral Nelfinavir at 3000 mg bid
10840920|NCT00233948|EG000|Reported Event|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
10840921|NCT00233948|EG001|Reported Event|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
10840922|NCT00233948|EG002|Reported Event|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
10840923|NCT00233948|EG003|Reported Event|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
10840924|NCT00233948|EG004|Reported Event|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
10840925|NCT00233948|EG005|Reported Event|Phase II|Oral Nelfinavir at 3000 mg bid
10840926|NCT00233987|BG000|Baseline|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
10840927|NCT00233987|FG000|Participant Flow|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
10840928|NCT00233987|OG000|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
10840929|NCT00233987|EG000|Reported Event|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
10840930|NCT00234039|BG000|Baseline|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
10840931|NCT00234039|FG000|Participant Flow|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
10840932|NCT00234039|OG000|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
10840933|NCT00234039|EG000|Reported Event|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
10840934|NCT00234052|BG000|Baseline|Treatment With Carboplatin + Pemetrexed + Bevacizumab|"Carboplatin + Pemetrexed + Bevacizumab~Patients will receive 6 cycles where (1 cycle is 21 days) of :~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle~Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle"
11329349|NCT03442777|BG001|Baseline|Intervention Group 2 (on Top of Standard of Care)|"Mepilex® brand silicone adhesive multilayer foam dressings~Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand)."
11329350|NCT03442777|BG002|Baseline|Control Group (Standard of Care)|"Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left)."
11329351|NCT03442777|BG003|Baseline|Total|Total of all reporting groups
11329352|NCT03442777|FG000|Participant Flow|Intervention Group 1 (on Top of Standard of Care)|"Allevyn® brand silicone adhesive multilayer foam dressings~Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand)."
11329353|NCT03442777|FG001|Participant Flow|Intervention Group 2 (on Top of Standard of Care)|"Mepilex® brand silicone adhesive multilayer foam dressings~Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand)."
11329354|NCT03442777|FG002|Participant Flow|Control Group (Standard of Care)|"Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left)."
11329355|NCT03442777|OG000|Outcome|Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2)|"Participants in intervention groups 1 and 2~were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay.~received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care.~Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention.~The maximum treatment duration was 14 days"
11329356|NCT03442777|OG001|Outcome|Control Group|"Participants in control group~were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay.~received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care.~No silicone adhesive multilayer foam dressings were applied~The maximum study duration was 14 days"
11329357|NCT03442777|EG000|Reported Event|Intervention Group 1 (on Top of Standard of Care)|"Allevyn® brand silicone adhesive multilayer foam dressings~Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand)."
11329358|NCT03442777|EG001|Reported Event|Intervention Group 2 (on Top of Standard of Care)|"Mepilex® brand silicone adhesive multilayer foam dressings~Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.~Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand)."
11329359|NCT03442829|BG000|Baseline|Sweet Food Consumption|"Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided.~Sweet food consumption: Sweet food consumption at breakfast"
11329360|NCT03442829|BG001|Baseline|Non-sweet Food Consumption|"Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.~Non-sweet food consumption: Non-sweet food consumption at breakfast"
11329361|NCT03442829|BG002|Baseline|Total|Total of all reporting groups
11329362|NCT03442829|FG000|Participant Flow|Sweet Food Consumption|"Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided.~Sweet food consumption: Sweet food consumption at breakfast"
11329363|NCT03442829|FG001|Participant Flow|Non-sweet Food Consumption|"Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.~Non-sweet food consumption: Non-sweet food consumption at breakfast"
11329364|NCT03442829|OG000|Outcome|Sweet Food Consumption|"Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided.~Sweet food consumption: Sweet food consumption at breakfast"
11329365|NCT03442829|OG001|Outcome|Non-sweet Food Consumption|"Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.~Non-sweet food consumption: Non-sweet food consumption at breakfast"
11329366|NCT03442829|EG000|Reported Event|Sweet Food Consumption|"Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided.~Sweet food consumption: Sweet food consumption at breakfast"
11329367|NCT03442829|EG001|Reported Event|Non-sweet Food Consumption|"Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.~Non-sweet food consumption: Non-sweet food consumption at breakfast"
11329368|NCT03442868|BG000|Baseline|High Frequency rTMS|"High frequency rTMS will be applied to different neural loci based on the randomized sessions.~high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation."
11329369|NCT03442868|FG000|Participant Flow|High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)|"High frequency rTMS will be applied to different neural loci based on the randomized sessions.~high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation."
11329370|NCT03442868|OG000|Outcome|High Frequency rTMS|"High frequency rTMS will be applied to different neural loci based on the randomized sessions.~high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation."
11329371|NCT03442868|EG000|Reported Event|High Frequency rTMS|"High frequency rTMS will be applied to different neural loci based on the randomized sessions.~high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation."
11329372|NCT03442933|BG000|Baseline|All Study Participants|Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group.
11329373|NCT03442933|FG000|Participant Flow|Road Cycling First, Then Mountain Biking|They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.
11329374|NCT03442933|FG001|Participant Flow|Mountain Biking First, Then Road Cycling.|They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
11329375|NCT03442933|OG000|Outcome|Road Cycling First, Then Mountain Biking|"First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).~3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic.~3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty."
11329376|NCT03442933|OG001|Outcome|Mountain Biking First, Then Road Cycling|"First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).~3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic.~3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty."
11329377|NCT03442933|OG000|Outcome|Road Cycling First, Then Mountain Biking|They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.
11329378|NCT03442933|OG001|Outcome|Mountain Biking First, Then Road Cycling.|They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
11329379|NCT03442933|OG000|Outcome|All Study Participants|Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group.
11329380|NCT03442933|EG000|Reported Event|Road Cycling First, Then Mountain Biking|They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.
11329381|NCT03442933|EG001|Reported Event|Mountain Biking First, Then Road Cycling|They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
11329382|NCT03443024|BG000|Baseline|125 mg Lebrikizumab (Q4W)|125 mg Lebrikizumab administered SC once every 4 weeks.
11329383|NCT03443024|BG001|Baseline|250 mg Lebrikizumab (Q4W)|250 mg Lebrikizumab administered SC once every 4 weeks.
11329384|NCT03443024|BG002|Baseline|250 mg Lebrikizumab (Q2W)|250 mg Lebrikizumab administered SC once every 2 weeks.
11329385|NCT03443024|BG003|Baseline|Placebo|Placebo administered SC once every 2 weeks.
11329386|NCT03443024|BG004|Baseline|Total|Total of all reporting groups
11329387|NCT03443024|FG000|Participant Flow|125 Milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)|"125 milligrams (mg) Lebrikizumab administered subcutaneously (SC) once every Q4W.~Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-mL of 125 mg/mL Lebrikizumab and 1-mL placebo).~Week 2: Four 1-mL SC injections placebo.~Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo.~Weeks 6, 10, 14: Two 1-mL SC placebo."
11329388|NCT03443024|FG001|Participant Flow|250 mg Lebrikizumab (Q4W)|"250 mg Lebrikizumab administered SC once every 4 weeks.~Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).~Week 2: Four 1-mL SC injections of placebo.~Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab).~Weeks 6, 10, 14: Two 1-mL injections of placebo."
11329389|NCT03443024|FG002|Participant Flow|250 mg Lebrikizumab - Every 2 Weeks (Q2W)|"250 mg Lebrikizumab administered SC once every 2 weeks.~Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).~Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab)."
11329390|NCT03443024|FG003|Participant Flow|Placebo|"Placebo administered SC once every 2 weeks.~Baseline and Week 2: Four 1-mL SC injections of placebo.~Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo."
11329391|NCT03443024|OG000|Outcome|125 mg Lebrikizumab (Q4W)|125 mg Lebrikizumab administered SC once Q4W.
10840935|NCT00234052|FG000|Participant Flow|Treatment With Carboplatin + Pemetrexed + Bevacizumab|"Carboplatin + Pemetrexed + Bevacizumab~Patients will receive 6 cycles where (1 cycle is 21 days) of :~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle~Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle"
10840936|NCT00234052|OG000|Outcome|Treatment With Carboplatin + Pemetrexed + Bevacizumab|"Carboplatin + Pemetrexed + Bevacizumab~Patients will receive 6 cycles where (1 cycle is 21 days) of :~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle~Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle"
10840937|NCT00234052|EG000|Reported Event|Treatment With Carboplatin + Pemetrexed + Bevacizumab|"Carboplatin + Pemetrexed + Bevacizumab~Patients will receive 6 cycles where (1 cycle is 21 days) of :~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle~Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:~Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle"
10840938|NCT00234065|BG000|Baseline|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
10840939|NCT00234065|BG001|Baseline|Aspirin|Aspirin, oral tablet, 81 mg aspirin
10840940|NCT00234065|BG002|Baseline|Total|Total of all reporting groups
10840941|NCT00234065|FG000|Participant Flow|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
10840942|NCT00234065|FG001|Participant Flow|Aspirin|Aspirin, oral tablet, 81 mg aspirin
10840943|NCT00234065|OG000|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
10840944|NCT00234065|OG001|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
10840945|NCT00234065|EG000|Reported Event|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
10840946|NCT00234065|EG001|Reported Event|Aspirin|Aspirin, oral tablet, 81 mg aspirin
10840947|NCT00234078|BG000|Baseline|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840948|NCT00234078|BG001|Baseline|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840949|NCT00234078|BG002|Baseline|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840950|NCT00234078|BG003|Baseline|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840951|NCT00234078|BG004|Baseline|Total|Total of all reporting groups
10840952|NCT00234078|FG000|Participant Flow|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840953|NCT00234078|FG001|Participant Flow|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840954|NCT00234078|FG002|Participant Flow|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840955|NCT00234078|FG003|Participant Flow|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840956|NCT00234078|OG000|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840957|NCT00234078|OG001|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840958|NCT00234078|OG002|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840959|NCT00234078|OG003|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840960|NCT00234078|EG000|Reported Event|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840961|NCT00234078|EG001|Reported Event|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840962|NCT00234078|EG002|Reported Event|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840963|NCT00234078|EG003|Reported Event|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
10840964|NCT00234104|BG000|Baseline|Placebo|OPC-41061 0 mg/day
10840965|NCT00234104|BG001|Baseline|15 mg of OPC-41061|OPC-41061 15 mg/day
10840966|NCT00234104|BG002|Baseline|30 mg of OPC-41061|OPC-41061 30 mg/day
10840967|NCT00234104|BG003|Baseline|45 mg of OPC-41061|OPC-41061 45 mg/day
10840968|NCT00234104|BG004|Baseline|Total|Total of all reporting groups
10840969|NCT00234104|FG000|Participant Flow|Placebo|OPC-41061 0 mg/day
10840970|NCT00234104|FG001|Participant Flow|15 mg of OPC-41061|OPC-41061 15 mg/day
10840971|NCT00234104|FG002|Participant Flow|30 mg of OPC-41061|OPC-41061 30 mg/day
10840972|NCT00234104|FG003|Participant Flow|45 mg of OPC-41061|OPC-41061 45 mg/day
10840973|NCT00234104|OG000|Outcome|Placebo|OPC-41061 0 mg/day
10840974|NCT00234104|OG001|Outcome|15 mg of OPC-41061|OPC-41061 15 mg/day
10840975|NCT00234104|OG002|Outcome|30 mg of OPC-41061|OPC-41061 30 mg/day
11329392|NCT03443024|OG001|Outcome|250 mg Lebrikizumab (Q4W)|250 mg Lebrikizumab administered SC once Q4W.
11329393|NCT03443024|OG002|Outcome|250 mg Lebrikizumab (Q2W)|250 mg Lebrikizumab administered SC once Q2W.
11329394|NCT03443024|OG003|Outcome|Placebo|Placebo administered SC once Q2W.
11329395|NCT03443024|EG000|Reported Event|125 mg Lebrikizumab (Q4W)|125 mg Lebrikizumab administered SC once Q4W.
11329396|NCT03443024|EG001|Reported Event|250 mg Lebrikizumab (Q4W)|250 mg Lebrikizumab administered SC once Q4W.
11329397|NCT03443024|EG002|Reported Event|250 mg Lebrikizumab (Q2W)|250 mg Lebrikizumab administered SC once Q2W.
11329398|NCT03443024|EG003|Reported Event|Placebo|Placebo administered SC once Q2W.
11329399|NCT03443063|BG000|Baseline|Lemborexant: Severe Renal Impairment|Participants with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m^2 and not on dialysis) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329400|NCT03443063|BG001|Baseline|Lemborexant: Normal Renal Function|Participants with normal renal function (eGFR >=90 mL/min/1.73 m^2) matched to participants with severe renal impairment (matched according to age, race, sex, and BMI) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329401|NCT03443063|BG002|Baseline|Total|Total of all reporting groups
11329402|NCT03443063|FG000|Participant Flow|Lemborexant: Severe Renal Impairment|Participants with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 milliliters per minute (mL/min/1.73 square meter [m^2]) and not on dialysis) received a single dose of 10 milligrams (mg) lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329403|NCT03443063|FG001|Participant Flow|Lemborexant: Normal Renal Function|Participants with normal renal function (eGFR greater than or equal to (>=) 90 mL/min/1.73 m^2) demographically matched to participants with severe renal impairment (matched according to age, race, sex, and body mass index [BMI]) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329404|NCT03443063|OG000|Outcome|Lemborexant: Severe Renal Impairment|Participants with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m^2 and not on dialysis) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329405|NCT03443063|OG001|Outcome|Lemborexant: Normal Renal Function|Participants with normal renal function (eGFR >=90 mL/min/1.73 m^2) demographically matched to participants with severe renal impairment (matched according to age, race, sex, and BMI) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329406|NCT03443063|OG001|Outcome|Lemborexant: Normal Renal Function|Participants with normal renal function (eGFR >=90 mL/min/1.73 m^2) demographically matched to participants with severe renal impairment (matched according to age, race, sex, and BMI) received a single dose of 10 mg lemborexant (oral tablet) in the morning on Day 1 after an overnight fast.
11329407|NCT03443063|OG000|Outcome|Lemborexant: Severe Renal Impairment|Participants with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m^2 and not on dialysis) received a single dose of 10 mg lemborexant (oral tablet) in the morning after an overnight fast.
11329408|NCT03443063|EG000|Reported Event|Lemborexant: Severe Renal Impairment|Participants with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m^2 and not on dialysis) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329409|NCT03443063|EG001|Reported Event|Lemborexant: Normal Renal Function|Participants with normal renal function (eGFR >=90 mL/min/1.73 m^2) demographically matched to participants with severe renal impairment (matched according to age, race, sex, and BMI) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast.
11329410|NCT03443414|BG000|Baseline|RPL554 0.75 mg|Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329411|NCT03443414|BG001|Baseline|RPL554 1.5 mg|Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329412|NCT03443414|BG002|Baseline|RPL554 3.0 mg|Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329413|NCT03443414|BG003|Baseline|RPL554 6.0 mg|Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329414|NCT03443414|BG004|Baseline|Placebo|Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329415|NCT03443414|BG005|Baseline|Total Title|
11329416|NCT03443414|FG000|Participant Flow|RPL554 0.75 mg|Patients were randomized to receive 0.75 milligrams (mg) RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329417|NCT03443414|FG001|Participant Flow|RPL554 1.5 mg|Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329418|NCT03443414|FG002|Participant Flow|RPL554 3.0 mg|Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329419|NCT03443414|FG003|Participant Flow|RPL554 6.0 mg|Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329420|NCT03443414|FG004|Participant Flow|Placebo|Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329421|NCT03443414|OG000|Outcome|RPL554 0.75 mg|Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329422|NCT03443414|OG001|Outcome|RPL554 1.5 mg|Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329423|NCT03443414|OG002|Outcome|RPL554 3.0 mg|Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329424|NCT03443414|OG003|Outcome|RPL554 6.0 mg|Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329425|NCT03443414|OG004|Outcome|Placebo|Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329426|NCT03443414|EG000|Reported Event|RPL554 0.75 mg|Patients were randomized to receive 0.75 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329427|NCT03443414|EG001|Reported Event|RPL554 1.5 mg|Patients were randomized to receive 1.5 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329428|NCT03443414|EG002|Reported Event|RPL554 3.0 mg|Patients were randomized to receive 3.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329429|NCT03443414|EG003|Reported Event|RPL554 6.0 mg|Patients were randomized to receive 6.0 mg RPL554 administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329430|NCT03443414|EG004|Reported Event|Placebo|Patients were randomized to receive placebo administered by jet nebulizer twice daily (morning and evening) for 4 weeks.
11329431|NCT03443427|BG000|Baseline|Schedule 0-2-6 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).
11329432|NCT03443427|BG001|Baseline|Schedule 0-2-12 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
11329433|NCT03443427|BG002|Baseline|Total|Total of all reporting groups
11329434|NCT03443427|FG000|Participant Flow|Schedule 0-2-6 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).
11329435|NCT03443427|FG001|Participant Flow|Schedule 0-2-12 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
11329436|NCT03443427|OG000|Outcome|Schedule 0-2-6 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).
11329437|NCT03443427|OG001|Outcome|Schedule 0-2-12 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
11329438|NCT03443427|EG000|Reported Event|Schedule 0-2-6 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).
11329439|NCT03443427|EG001|Reported Event|Schedule 0-2-12 Group|Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
11329440|NCT03443713|BG000|Baseline|Aerobic Exercise|All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
11329441|NCT03443713|BG001|Baseline|Anaerobic Exercise|All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
11329442|NCT03443713|BG002|Baseline|High Intensity Interval Exercise|All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
11329443|NCT03443713|BG003|Baseline|Total|Total of all reporting groups
11329444|NCT03443713|FG000|Participant Flow|Aerobic Exercise|"Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329445|NCT03443713|FG001|Participant Flow|Anaerobic Exercise|"Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329446|NCT03443713|FG002|Participant Flow|High Intensity Interval Exercise|"Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329447|NCT03443713|OG000|Outcome|Aerobic Exercise|Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
11329448|NCT03443713|OG001|Outcome|Anaerobic Exercise|Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
11329449|NCT03443713|OG002|Outcome|High Intensity Interval Exercise|Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
11329450|NCT03443713|OG001|Outcome|Anaerobic Exercise|Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Subjects are on study for 28 days.
11329451|NCT03443713|OG002|Outcome|High Intensity Interval Exercise|Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Subjects are on study for 28 days.
11329452|NCT03443713|OG000|Outcome|Aerobic Exercise|Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Subjects are on study for 28 days.
11329453|NCT03443713|OG002|Outcome|High Intensity Interval Exercise|Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Subjects are on study for 28 days
11329454|NCT03443713|EG000|Reported Event|Aerobic Exercise|"Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329455|NCT03443713|EG001|Reported Event|Anaerobic Exercise|"Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329456|NCT03443713|EG002|Reported Event|High Intensity Interval Exercise|"Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.~Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study."
11329457|NCT03444090|BG000|Baseline|Insertion/Withdrawal Colon Polypectomy|For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
11329458|NCT03444090|BG001|Baseline|Withdrawal Colon Polypectomy|For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
11329459|NCT03444090|BG002|Baseline|Total|Total of all reporting groups
11329460|NCT03444090|FG000|Participant Flow|Insertion/Withdrawal Colon Polypectomy|For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
11329461|NCT03444090|FG001|Participant Flow|Withdrawal Colon Polypectomy|For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
11329462|NCT03444090|OG000|Outcome|Insertion/Withdrawal Colon Polypectomy|For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
11329463|NCT03444090|OG001|Outcome|Withdrawal Colon Polypectomy|For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
11329464|NCT03444090|EG000|Reported Event|Insertion/Withdrawal Colon Polypectomy|For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
11329465|NCT03444090|EG001|Reported Event|Withdrawal Colon Polypectomy|For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
11329466|NCT03444155|BG000|Baseline|Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex|Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
11329467|NCT03444155|BG001|Baseline|Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex|Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
11329468|NCT03444155|BG002|Baseline|Total|Total of all reporting groups
11329469|NCT03444155|FG000|Participant Flow|Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex|Participants first received Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Synthetic Vitamin B-complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
11329470|NCT03444155|FG001|Participant Flow|Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex|Participants first received Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
11329471|NCT03444155|OG000|Outcome|Panmol-B-Complex|Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
11335747|NCT03555565|EG000|Reported Event|Alogliptin and Metformin Hydrochloride|Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
11336272|NCT03565068|BG007|Baseline|Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg.
10840976|NCT00234104|OG003|Outcome|45 mg of OPC-41061|OPC-41061 45 mg/day
10840977|NCT00234104|EG000|Reported Event|Placebo|OPC-41061 0 mg/day
10840978|NCT00234104|EG001|Reported Event|15 mg of OPC-41061|OPC-41061 15 mg/day
10840979|NCT00234104|EG002|Reported Event|30 mg of OPC-41061|OPC-41061 30 mg/day
10840980|NCT00234104|EG003|Reported Event|45 mg of OPC-41061|OPC-41061 45 mg/day
10840981|NCT00234286|BG000|Baseline|Arm 1|"Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials"
10840982|NCT00234286|FG000|Participant Flow|BEACON Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
10840983|NCT00234286|OG000|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
10840984|NCT00234286|OG001|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
10840985|NCT00234286|OG000|Outcome|Pre-Intervention|Number of Individuals who died in ICU Pre-Intervention
10840986|NCT00234286|OG001|Outcome|Post-Intervention|Number of Patients who died in ICU Post-Intervention
10840987|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals who died with a nasogastric tube pre-intervention
10840988|NCT00234286|OG001|Outcome|Post-Intervention|Individuals who died with a nasogastric tube post-intervention
10840989|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals who died with an intravenous line pre-intervention
10840990|NCT00234286|OG001|Outcome|Post-Intervention|Individuals who died with an intravenous line post-intervention
10840991|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals who died with restraints during pre-intervention
10840992|NCT00234286|OG001|Outcome|Post-Intervention|Individuals who died with restraints during post-intervention
10840993|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals who received opioid medication pre-intervention
10840994|NCT00234286|OG001|Outcome|Post-intervention|Individuals who received opioid medication post-intervention
10840995|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with antipsychotic medication ordered pre-intervention
10840996|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with antipsychotic medication ordered post-intervention
10840997|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Administration of antipsychotic medication pre-intervention
10840998|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Administration of antipsychotic medication post-intervention
10840999|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Order for benzodiazepine medication during pre-intervention period based on abstraction of medical record
10841000|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Order for benzodiazepine medication during post-intervention period based on abstraction of medical record
10841001|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Administration of benzodiazepine medication during pre-intervention based on abstraction of medical record
10841002|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Administration of benzodiazepine medication during post-intervention based on abstraction of medical record
10841003|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Administration of scopolamine (for death rattle) during pre-intervention based on abstraction of medical record
10841004|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Administration of scopolamine (for death rattle) during post -intervention based on abstraction of medical record
10841005|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Sublingual administration of medication during pre-intervention based on abstraction of medical record
10841006|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Sublingual administration of medication during post-intervention based on abstraction of medical record
10841007|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Pastoral Care Visit pre-intervention based on abstraction of medical record
10841008|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Pastoral Care visit post-intervention based on abstraction of medical record
10841009|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with Advanced Directive pre-intervention based on abstraction of medical record
10841010|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with Advanced Directive post-intervention based on abstraction of medical record
10841011|NCT00234286|OG000|Outcome|Pre-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
10841012|NCT00234286|OG001|Outcome|Post-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
10841013|NCT00234286|EG000|Reported Event|Arm 1|Arm 1: Comfort care education intervention, consisting of intensive, on-site staff training
10841014|NCT00234494|BG000|Baseline|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
10841015|NCT00234494|FG000|Participant Flow|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
11329472|NCT03444155|OG001|Outcome|Synthetic Vitamin B-complex|Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
11329473|NCT03444155|EG000|Reported Event|Natural Panmol-B-Complex|Participants received a Natural Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.
11329474|NCT03444155|EG001|Reported Event|Synthetic Vitamin-B-Complex|Participants received a Synthetic Vitamin-B-Complex consisting of - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks (matching the Natural Panmol-B-Complex).
11329475|NCT03444584|BG000|Baseline|Placebo|Participants received subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329476|NCT03444584|BG001|Baseline|MEDI0382|Participants received subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329477|NCT03444584|BG002|Baseline|TOTAL|Total of all reporting groups
11329478|NCT03444584|FG000|Participant Flow|Placebo|Participants received subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329479|NCT03444584|FG001|Participant Flow|MEDI0382|Participants received subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329480|NCT03444584|OG000|Outcome|Placebo|Participants received subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329481|NCT03444584|OG001|Outcome|MEDI0382|Participants received subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329482|NCT03444584|OG000|Outcome|MEDI0382|Participants received subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329483|NCT03444584|EG000|Reported Event|Placebo|Participants received subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329484|NCT03444584|EG001|Reported Event|MEDI0382|Participants received subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
11329485|NCT03444766|BG000|Baseline|Nivolumab|3mg/kg IV q 2weeks
11329486|NCT03444766|FG000|Participant Flow|Nivolumab|3mg/kg IV q 2weeks
11329487|NCT03444766|OG000|Outcome|Nivolumab|3mg/kg IV q 2weeks
11329488|NCT03444766|EG000|Reported Event|Nivolumab|3mg/kg IV q 2weeks
11329489|NCT03444961|BG000|Baseline|CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329490|NCT03444961|FG000|Participant Flow|CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329491|NCT03444961|OG000|Outcome|Pre-CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329492|NCT03444961|OG001|Outcome|Post-CAREN Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329493|NCT03444961|OG000|Outcome|Pre - CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329494|NCT03444961|OG001|Outcome|Post-CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329495|NCT03444961|OG000|Outcome|CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329496|NCT03444961|EG000|Reported Event|CAREN System Training|"CAREN training~CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment."
11329497|NCT03445065|BG000|Baseline|Cohort 1, Enabled - Eversense XL CGM System|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329498|NCT03445065|BG001|Baseline|Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11336273|NCT03565068|BG008|Baseline|Panel D (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15.
11329499|NCT03445065|BG002|Baseline|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329500|NCT03445065|BG003|Baseline|Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11329501|NCT03445065|BG004|Baseline|Total|Total of all reporting groups
11329502|NCT03445065|FG000|Participant Flow|Cohort 1, Enabled - Eversense XL CGM System|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329503|NCT03445065|FG001|Participant Flow|Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329504|NCT03445065|FG002|Participant Flow|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329505|NCT03445065|FG003|Participant Flow|Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11329506|NCT03445065|OG000|Outcome|Cohort 1, Enabled - Eversense XL CGM System|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329507|NCT03445065|OG001|Outcome|Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329508|NCT03445065|OG000|Outcome|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329509|NCT03445065|OG001|Outcome|Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11335748|NCT03555890|BG000|Baseline|Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)|All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11336274|NCT03565068|BG009|Baseline|Total|Total of all reporting groups
11329510|NCT03445065|OG002|Outcome|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329511|NCT03445065|OG003|Outcome|Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11329512|NCT03445065|OG003|Outcome|Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. From Day 0 to 120, those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329513|NCT03445065|OG004|Outcome|Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11329514|NCT03445065|OG000|Outcome|Cohort 2, Enabled (Day 90 to 120) - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329515|NCT03445065|OG001|Outcome|Cohort 2, Enabled (Day 150 to 180) - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329516|NCT03445065|OG000|Outcome|Cohort 2, Control (Day 90 to 120) - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329517|NCT03445065|OG001|Outcome|Cohort 2, Switch From Control to Enabled (Day 150 to 180) - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group switched to have the CGM system enabled until the end of the study (Day 180).
11329518|NCT03445065|OG001|Outcome|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329519|NCT03445065|EG000|Reported Event|Cohort 1, Enabled - Eversense XL CGM System|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329520|NCT03445065|EG001|Reported Event|Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c >8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329521|NCT03445065|EG002|Reported Event|Cohort 2, Enabled - Eversense XL CGM System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
11329522|NCT03445065|EG003|Reported Event|Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM)|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. From Day 0 to 120, those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]), and the implanted Eversense XL CGM System remained in blinded mode.
11329523|NCT03445065|EG004|Reported Event|Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System|Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending >1.5 hours per day with a sensor mean glucose of <70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
11329524|NCT03445156|BG000|Baseline|Pilot Study: Violent Shooter|Resident Evil: The Darkside Chronicles, a violent shooter game which rewards players for shooting realistic human targets. Headshots are rewarded.
11329525|NCT03445156|BG001|Baseline|Pilot Study: Non-violent Shooter|Wii Play, a non-violent shooter which punishes players for hitting bull's-eye targets with faces on them and rewards players for shooting other targets (e.g., balloons, clay discs, bull's-eye targets without faces).
11329526|NCT03445156|BG002|Baseline|Study Proper: Violent Shooter|Resident Evil: The Darkside Chronicles, a violent shooter game which rewards players for shooting realistic human targets. Headshots are rewarded.
11329527|NCT03445156|BG003|Baseline|Study Proper: Non-violent Shooter|Wii Play, a non-violent shooter which punishes players for hitting bull's-eye targets with faces on them and rewards players for shooting other targets (e.g., balloons, clay discs, bull's-eye targets without faces).
11329528|NCT03445156|BG004|Baseline|Study Proper: Non-violent Game|Super Mario Galaxy, a non-violent game which rewards players for collecting stars and completing challenging levels in a creative, animated world. Does not involve shooting a weapon.
11329529|NCT03445156|BG005|Baseline|Total|Total of all reporting groups
11329530|NCT03445156|FG000|Participant Flow|Violent Shooter Game|Resident Evil: The Darkside Chronicles, a violent shooter game which rewards players for shooting realistic human targets. Headshots are rewarded.
11329531|NCT03445156|FG001|Participant Flow|Non-violent Shooter Game|Wii Play, a non-violent shooter which punishes players for hitting bull's-eye targets with faces on them and rewards players for shooting other targets (e.g., balloons, clay discs, bull's-eye targets without faces).
11329532|NCT03445156|FG002|Participant Flow|Non-violent Game|Super Mario Galaxy, a non-violent game which rewards players for collecting stars and completing challenging levels in a creative, animated world. Does not involve shooting a weapon.
11329533|NCT03445156|OG000|Outcome|Pilot Study: Violent Shooter Game|Resident Evil: The Darkside Chronicles, a violent shooter game which rewards players for shooting realistic human targets. Headshots are rewarded.
11329534|NCT03445156|OG001|Outcome|Pilot Study: Non-violent Shooter Game|Wii Play, a non-violent shooter which punishes players for hitting bull's-eye targets with faces on them and rewards players for shooting other targets (e.g., balloons, clay discs, bull's-eye targets without faces).
11329535|NCT03445156|OG002|Outcome|Experiment Proper: Violent Shooter Game|Resident Evil: The Darkside Chronicles, a violent shooter game which rewards players for shooting realistic human targets. Headshots are rewarded.
11329536|NCT03445156|OG003|Outcome|Experiment Proper: Non-violent Shooter Game|Wii Play, a non-violent shooter which punishes players for hitting bull's-eye targets with faces on them and rewards players for shooting other targets (e.g., balloons, clay discs, bull's-eye targets without faces).
11329537|NCT03445156|OG004|Outcome|Experiment Proper: Non-violent Game|Super Mario Galaxy, a non-violent game which rewards players for collecting stars and completing challenging levels in a creative, animated world. Does not involve shooting a weapon.
11329538|NCT03445156|EG000|Reported Event|Pilot Study: Violent Shooter|20 participants assigned to play a violent shooter game
11329539|NCT03445156|EG001|Reported Event|Pilot Study: Non-violent Shooter|20 participants assigned to play a non-violent shooter game
11329540|NCT03445156|EG002|Reported Event|Study Proper: Violent Shooter|113 participants assigned to play a violent shooter game
11329541|NCT03445156|EG003|Reported Event|Study Proper: Non-violent Shooter|115 participants assigned to play a non-violent shooter game
10841016|NCT00234494|OG000|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
11329542|NCT03445156|EG004|Reported Event|Study Proper: Non-violent Game|59 participants assigned to play a non-violent game
11329543|NCT03445195|BG000|Baseline|Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin|"Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329544|NCT03445195|BG001|Baseline|Placebo + Imipenem/Cilastatin|"Placebo: Matching 1g IV solution.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329545|NCT03445195|BG002|Baseline|Total|Total of all reporting groups
11329546|NCT03445195|FG000|Participant Flow|Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin|"Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329547|NCT03445195|FG001|Participant Flow|Placebo + Imipenem/Cilastatin|"Placebo: Matching 1g IV solution.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329548|NCT03445195|OG000|Outcome|Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin|"Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329549|NCT03445195|OG001|Outcome|Placebo + Imipenem/Cilastatin|"Placebo: Matching 1g IV solution.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329550|NCT03445195|EG000|Reported Event|Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin|"Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329551|NCT03445195|EG001|Reported Event|Placebo + Imipenem/Cilastatin|"Placebo: Matching 1g IV solution.~Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h."
11329552|NCT03445390|BG000|Baseline|All Study Participants|Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
11329553|NCT03445390|FG000|Participant Flow|Acetaminophen First, Then Placebo|Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
11329554|NCT03445390|FG001|Participant Flow|Placebo First, Then Acetaminophen|Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
11329555|NCT03445390|OG000|Outcome|Acetaminophen|Patients were administered intravenous acetaminophen (1 g IV) twice.
11329556|NCT03445390|OG001|Outcome|Placebo|Patients were administered placebo to match acetaminophen.
11329557|NCT03445390|EG000|Reported Event|Acetaminophen|Patients were administered intravenous acetaminophen (1 g IV) twice.
11329558|NCT03445390|EG001|Reported Event|Placebo|Patients were administered placebo to match acetaminophen.
11329559|NCT03445793|BG000|Baseline|Observational|Participants who have cystic fibrosis and are clinically stable at time of transition from Lumacaftor/Ivacaftor to tezacaftor/ivacaftor as a continuous treatment as determined by their clinical physician.
11329560|NCT03445793|FG000|Participant Flow|Observational|Participants who have cystic fibrosis and are clinically stable at time of transition from Lumacaftor/Ivacaftor to tezacaftor/ivacaftor as a continuous treatment as determined by their clinical physician.
11329561|NCT03445793|OG000|Outcome|Observational|Participants who have cystic fibrosis and are clinically stable at time of transition from Lumacaftor/Ivacaftor to tezacaftor/ivacaftor as a continuous treatment as determined by their clinical physician.
11329562|NCT03445793|EG000|Reported Event|Observational|Participants who have cystic fibrosis and are clinically stable at time of transition from Lumacaftor/Ivacaftor to tezacaftor/ivacaftor as a continuous treatment as determined by their clinical physician.
11329563|NCT03446053|BG000|Baseline|INT200-Placebo (Single Dose Study + Multi Dose Study)|"Saline~INT200-Placebo: Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes"
11329564|NCT03446053|BG001|Baseline|N-Rephasin® SAL200 6mg/kg (Single Dose)|"Sigle dose N-Rephasin® SAL200 6mg/kg (single dose)~Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329565|NCT03446053|BG002|Baseline|N-Rephasin® SAL200 1.5 mg/kg (3mg/kg/d), Multi Dose|"Multi dose Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329566|NCT03446053|BG003|Baseline|N-Rephasin® SAL200 3mg/kg (6mg/kg/d), Multi Dose|"Multi dose Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329567|NCT03446053|BG004|Baseline|N-Rephasin® SAL200 4.5mg/kg (9mg/kg/d), Multi Dose|"Multi dose Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329568|NCT03446053|BG005|Baseline|Total|Total of all reporting groups
11329569|NCT03446053|FG000|Participant Flow|Placebo, Single Dose Study|INT200-Placebo, single dose, IP administration: 1d 0h
11329570|NCT03446053|FG001|Participant Flow|N-Rephasin® SAL200 6mg/kg (Single Dose)|"Sigle dose group N-Rephasin® SAL200 6mg/kg (single dose)~Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329571|NCT03446053|FG002|Participant Flow|Placebo , Multiple Dose Study|INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
11329572|NCT03446053|FG003|Participant Flow|N-Rephasin® SAL200 1.5 mg/kg (3mg/kg/d) , Multi Dose|"multi dose study Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329573|NCT03446053|FG004|Participant Flow|N-Rephasin® SAL200 3mg/kg (6mg/kg/d), Multi Dose|"Multi dose study Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329574|NCT03446053|FG005|Participant Flow|N-Rephasin® SAL200 4.5mg/kg (9mg/kg/d), Multi Dose|"Multi dose study Experimental: N-Rephasin® SAL200~Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection~continuous intravenous infusion over 60 minutes~Healthy Volunteers who were met eligibility criteria."
11329575|NCT03446053|OG000|Outcome|Placebo, Single Dose Study|INT200-Placebo, single dose, IP administration: 1d 0h
11329576|NCT03446053|OG001|Outcome|N-Rephasin® SAL200 (6mg/kg), Single Dose Study|SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
11329577|NCT03446053|OG002|Outcome|Placebo , Multiple Dose Study|INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
11329578|NCT03446053|OG003|Outcome|N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study|SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
11329579|NCT03446053|OG004|Outcome|N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study|SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
11329580|NCT03446053|OG005|Outcome|N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study|SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
11329581|NCT03446053|OG000|Outcome|N-Rephasin® SAL200 (6mg/kg)|SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose
11329582|NCT03446053|OG001|Outcome|N-Rephasin® SAL200 (1.5 mg/kg)|SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), single IV administration of N-Rephasin® SAL200
11329583|NCT03446053|OG002|Outcome|N-Rephasin® SAL200 (3 mg/kg)|SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , single IV administration
11329584|NCT03446053|OG003|Outcome|N-Rephasin® SAL200 (4.5 mg/kg)|SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), single IV administration
11329585|NCT03446053|OG000|Outcome|6 mg/kg|single IV administration of N Rephasin® SAL200 IV administration.
11329586|NCT03446053|OG001|Outcome|1.5 mg/kg|after single IV administration of N Rephasin® SAL200 IV administration.
11329587|NCT03446053|OG002|Outcome|3 mg/kg|single IV administration of N Rephasin® SAL200 IV administration.
11329588|NCT03446053|OG003|Outcome|4.5 mg/kg|single IV administration of N Rephasin® SAL200 IV administration.
11329589|NCT03446053|OG000|Outcome|Placebo (Single Dose Study + Multi Dose Study)|INT200-Placebo (single dose study (2 participants) + multi dose study (6 participants) = total 8 participants)
11329590|NCT03446053|OG001|Outcome|SAL200 N-Rephasin® SAL200 (6mg/kg) (Single Dose Study)|SAL200 1 ml (SAL-1 18 mg/mL) , 6 mg/kg (Single dose study)
11329591|NCT03446053|OG002|Outcome|SAL200 1.5 mg/kg (3 mg/kg/d) (Multi Dose Study)|SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day) (Multi dose study)
11329592|NCT03446053|OG003|Outcome|SAL200 3 mg/kg (6 mg/kg/d) (Multi Dose Study)|SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) (Multi dose study)
11329593|NCT03446053|OG004|Outcome|SAL200 4.5 mg/kg (9 mg/kg/d) (Multi Dose Study)|SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day) (Multi dose study)
11329594|NCT03446053|EG000|Reported Event|Placebo, Single Dose Study|INT200-Placebo (N=2),single dose study
11329595|NCT03446053|EG001|Reported Event|N-Rephasin® SAL200 (6mg/kg), Single Dose Study|N-Rephasin® SAL200 (6mg/kg), (N=6),single dose study
11329596|NCT03446053|EG002|Reported Event|Placebo , Multiple Dose Study|INT200-Placebo (N=6),multiple dose study
11329597|NCT03446053|EG003|Reported Event|N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study|N-Rephasin® SAL200 (1.5mg/kg), (N=6),multiple dose study
11329598|NCT03446053|EG004|Reported Event|N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study|N-Rephasin® SAL200 (3mg/kg), (N=6),multiple dose study
11329599|NCT03446053|EG005|Reported Event|N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study|N-Rephasin® SAL200 (4.5mg/kg), (N=6),multiple dose study
11329600|NCT03446690|BG000|Baseline|MI Varnish Group|33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB.
11329601|NCT03446690|BG001|Baseline|Control Group|A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects were patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
11329602|NCT03446690|BG002|Baseline|Total|Total of all reporting groups
11329603|NCT03446690|FG000|Participant Flow|MI Varnish Group|"33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. 29 subjects were recruited retrospectively from a previous study and the results compared.~MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals."
11329604|NCT03446690|FG001|Participant Flow|Control Group|"A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.~Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group."
11329605|NCT03446690|OG000|Outcome|MI Varnish Group|33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
11329606|NCT03446690|OG001|Outcome|Control Group|"A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.~Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group."
11329607|NCT03446690|EG000|Reported Event|MI Varnish Group|33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
11329608|NCT03446690|EG001|Reported Event|Control Group|"A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.~Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group."
11329609|NCT03446781|BG000|Baseline|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11329610|NCT03446781|BG001|Baseline|Placebo|Placebo-control
11329611|NCT03446781|BG002|Baseline|Total|Total of all reporting groups
10841017|NCT00234494|EG000|Reported Event|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
10841018|NCT00234533|BG000|Baseline|NutropinAq 10 mg/2 ml (30 IU)|"Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:~GHD patients: 0.025 - 0.035 mg/kg bodyweight~TS patients: up to 0.05 mg/kg bodyweight~CRI patients: up to 0.05 mg/kg bodyweight~Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.~The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening."
10841019|NCT00234533|FG000|Participant Flow|NutropinAq 10 mg/2 ml (30 IU)|"Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/ 2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:~GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight~TS patients: up to 0.05 mg/kg bodyweight~CRI patients: up to 0.05 mg/kg bodyweight~Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.~The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening."
10841020|NCT00234533|OG000|Outcome|NutropinAq 10 mg/2 ml (30 IU)|"Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:~GHD patients: 0.025 - 0.035 mg/ kilogram kg bodyweight~TS patients: up to 0.05 mg/kg bodyweight~CRI patients: up to 0.05 mg/kg bodyweight~Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.~The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening."
10841021|NCT00234533|OG000|Outcome|NutropinAq 10 mg/2 ml (30 IU)|"Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:~GHD patients: 0.025 - 0.035 mg/kg bodyweight~TS patients: up to 0.05 mg/kg bodyweight~CRI patients: up to 0.05 mg/kg bodyweight~Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.~The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening."
10841022|NCT00234533|EG000|Reported Event|NutropinAq 10 mg/2 ml (30 IU)|"Patients received daily s.c. injections of NutropinAq 10 mg/ 2 mL for 6 months. The therapeutic daily doses administered were as follows:~GHD patients: 0.025 - 0.035 mg/kg bodyweight~TS patients: up to 0.05 mg/kg bodyweight~CRI patients: up to 0.05 mg/kg bodyweight~Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.~The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening."
10841023|NCT00234832|BG000|Baseline|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841024|NCT00234832|BG001|Baseline|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841025|NCT00234832|BG002|Baseline|Total|Total of all reporting groups
10841026|NCT00234832|FG000|Participant Flow|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841027|NCT00234832|FG001|Participant Flow|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841028|NCT00234832|OG000|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841029|NCT00234832|OG001|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
10841030|NCT00234832|OG002|Outcome|DM Only Randomized to Sibutramine|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
10841031|NCT00234832|OG003|Outcome|DM Only Randomized to Placebo|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
10841032|NCT00234832|OG004|Outcome|CV Only Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
11329612|NCT03446781|FG000|Participant Flow|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11329613|NCT03446781|FG001|Participant Flow|Placebo|Placebo-control
11329614|NCT03446781|OG000|Outcome|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock
11329615|NCT03446781|OG001|Outcome|Placebo|Placebo-control
11329616|NCT03446781|OG000|Outcome|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock (1.68 mg Total Dose)
11329617|NCT03446781|OG000|Outcome|Day 1: CCH|Baseline (Day 1) for CCH Treated Group
11329618|NCT03446781|OG001|Outcome|Day 1: Placebo|Baseline (Day 1) for PlaceboGroup
11329619|NCT03446781|OG002|Outcome|Day 22: CCH|Day 22 for CCH Treated Group
11329620|NCT03446781|OG003|Outcome|Day 22: Placebo|Day 22 for Placebo Group
11329621|NCT03446781|OG004|Outcome|Day 43: CCH|Day 43 for CCH Treated Group
11329622|NCT03446781|OG005|Outcome|Day 43: Placebo|Day 43 for Placebo Group
11329623|NCT03446781|OG006|Outcome|Day 71: CCH|Day 71 for CCH Treated Group
11329624|NCT03446781|OG007|Outcome|Day 71: Placebo|Day 71 for Placebo Group
11329625|NCT03446781|OG008|Outcome|Day 71: CCH (LOCF)|Day 71 for CCH Treated Group (Last Observation Carried Forward)
11329626|NCT03446781|OG009|Outcome|Day 71: Placebo (LOCF)|Day 71 for Placebo Group (Last Observation Carried Forward)
11329627|NCT03446781|OG000|Outcome|Day 71: CCH|Day 71 for CCH Treated Group
11329628|NCT03446781|OG001|Outcome|Day 71: Placebo|Day 71 for Placebo Group
11329629|NCT03446781|OG002|Outcome|Day 71: CCH (LOCF)|Day 71 for CCH Treated Group (Last Observation Carried Forward)
11329630|NCT03446781|OG003|Outcome|Day 71: Placebo (LOCF)|Day 71 for Placebo Group (Last Observation Carried Forward)
11329631|NCT03446781|OG000|Outcome|Anti-AUX-I: CCH|Antibody AUX-I for the CCH Treated Group
11329632|NCT03446781|OG001|Outcome|Anti-AUX-I: Placebo|Antibody AUX-I for the Placebo Group
11329633|NCT03446781|OG002|Outcome|Anti-AUX-II: CCH|Antibody AUX-II for the CCH Treated Group
11329634|NCT03446781|OG003|Outcome|Anti-AUX-II: Placebo|Antibody AUX-II for the Placebo Group
11329635|NCT03446781|OG000|Outcome|CCH: Q1|Q1 for the CCH Treated Group
11329636|NCT03446781|OG001|Outcome|CCH: Q4|Q4 for the CCH Treated Group
11329637|NCT03446781|OG002|Outcome|CCH: Total|Total CCH
11329638|NCT03446781|EG000|Reported Event|Collagenase Clostridium Histolyticum (CCH)|CCH 0.84 mg/Buttock 1.68 mg Total Dose
11329639|NCT03446781|EG001|Reported Event|Placebo|Placebo-control
11329640|NCT03446846|BG000|Baseline|5.0 mg MIN-117|MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.
11329641|NCT03446846|BG001|Baseline|2.5 mg MIN-117|MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.
11329642|NCT03446846|BG002|Baseline|Placebo|Placebo taken as two Placebo capsules as a single dose orally once daily.
11329643|NCT03446846|BG003|Baseline|Total|Total of all reporting groups
11329644|NCT03446846|FG000|Participant Flow|5.0 mg MIN-117|MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.
11329645|NCT03446846|FG001|Participant Flow|2.5 mg MIN-117|MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.
11329646|NCT03446846|FG002|Participant Flow|Placebo|Placebo taken as two Placebo capsules as a single dose orally once daily.
11329647|NCT03446846|OG000|Outcome|5.0 mg MIN-117|MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose once daily.
11329648|NCT03446846|OG001|Outcome|2.5 mg MIN-117|MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily.
11329649|NCT03446846|OG002|Outcome|Placebo|Placebo taken as two Placebo capsules as a single dose once daily.
11329650|NCT03446846|EG000|Reported Event|5.0 mg MIN-117|MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.
11329651|NCT03446846|EG001|Reported Event|2.5 mg MIN-117|MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.
11329652|NCT03446846|EG002|Reported Event|Placebo|Placebo taken as two Placebo capsules as a single dose orally once daily.
11329653|NCT03446885|BG000|Baseline|ADHD Participant|Administration of placebo capsule/Vyvanse 40 mg on different days in a cross-over design
11329654|NCT03446885|FG000|Participant Flow|Allocated to Vyvanse First|Administration of Vyvanse 40 mg then placebo on different days in a cross-over design
11329655|NCT03446885|FG001|Participant Flow|Allocated to Placebo First|Allocated to placebo then Vyvanse 40 mg on different days
11329656|NCT03446885|OG000|Outcome|Placebo|Placebo
11329657|NCT03446885|OG001|Outcome|Vyvanse|40 mg Vyvanse
11329658|NCT03446885|OG000|Outcome|Placebo|"40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.~Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally~Placebo: Placebo capsule administered orally"
11329659|NCT03446885|OG001|Outcome|Vyvanse|"40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.~Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally~Placebo: Placebo capsule administered orally"
11329660|NCT03446885|EG000|Reported Event|Placebo|Placebo
11329661|NCT03446885|EG001|Reported Event|Vyvanse|40 mg Vyvanse
11329662|NCT03447015|BG000|Baseline|Intervention|"women will be encouraged to ambulate Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).~ambulation: Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking)."
11329663|NCT03447015|BG001|Baseline|Control|women will receive usual maternity care.
11329664|NCT03447015|BG002|Baseline|Total|Total of all reporting groups
11329665|NCT03447015|FG000|Participant Flow|Intervention|"women will be encouraged to ambulate Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).~ambulation: Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking)."
11329666|NCT03447015|FG001|Participant Flow|Control|women will receive usual maternity care.
11329667|NCT03447015|OG000|Outcome|Intervention|"women will be encouraged to ambulate Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).~ambulation: Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking)."
11329668|NCT03447015|OG001|Outcome|Control|women will receive usual maternity care.
11329669|NCT03447015|EG000|Reported Event|Intervention|"women will be encouraged to ambulate Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).~ambulation: Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking)."
11329670|NCT03447015|EG001|Reported Event|Control|women will receive usual maternity care.
11329671|NCT03447249|BG000|Baseline|Placebo|Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11329672|NCT03447249|BG001|Baseline|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329673|NCT03447249|BG002|Baseline|Total|Total of all reporting groups
11329674|NCT03447249|FG000|Participant Flow|Placebo|Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11329675|NCT03447249|FG001|Participant Flow|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329676|NCT03447249|OG000|Outcome|Placebo|Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11329677|NCT03447249|OG001|Outcome|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329678|NCT03447249|OG001|Outcome|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329679|NCT03447249|OG000|Outcome|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329680|NCT03447249|EG000|Reported Event|Placebo|Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11329681|NCT03447249|EG001|Reported Event|VX-659/TEZ/IVA TC|Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11329682|NCT03447353|BG000|Baseline|All Study Participants|"All participants were randomized to receive all interventions.~Sober or Double Placebo: Participant receives two tablets, both containing placebo.~Active Xanax, Active Norco: Participant receives two tablets, one containing Xanax and one containing Norco Active Xanax, Placebo Norco: Participant receives two tablets, one containing Xanax and one containing placebo Placebo Xanax, Active Norco: Participant receives two tablets, one containing Norco and one containing placebo~Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam"
11329683|NCT03447353|FG000|Participant Flow|Overall Study|"Individuals who completed the study completed all four arms of the study and the data is aggregated. Subjects who did not complete the study may have completed one arm and their data is not included in the analysis. There was a screening visit and four study visits where the subject arrived at the National Advanced Driving Simulator. At each study visit, subjects received one of the following four dosing regimens: double placebo or Sober; active Xanax with active Norco, active Xanax and placebo Norco, and placebo Xanax and active Norco."
11329684|NCT03447353|OG000|Outcome|"Sober or Double Placebo"|"Subject receives two tablets, both containing placebo~Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits"
11329685|NCT03447353|OG001|Outcome|Active Xanax, Active Norco|"Subject receives two tablets, one containing Xanax and one containing Norco~Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco~Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam"
11329686|NCT03447353|OG002|Outcome|Active Xanax, Placebo Norco|"Subject receives two tablets, one containing Xanax and one containing placebo~Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco~Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits"
11329687|NCT03447353|OG003|Outcome|Placebo Xanax, Active Norco|"Subject receives two tablets, one containing Norco and one containing placebo~Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam~Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits"
11329688|NCT03447353|EG000|Reported Event|"Sober or Double Placebo"|Participant receives two tablets, both containing placebo.
11329689|NCT03447353|EG001|Reported Event|Active Xanax, Active Norco|"Participant receives two tablets, one containing Xanax and one containing Norco~Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam"
11329690|NCT03447353|EG002|Reported Event|Active Xanax, Placebo Norco|"Participant receives two tablets, one containing Xanax and one containing placebo~Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco"
11329691|NCT03447353|EG003|Reported Event|Placebo Xanax, Active Norco|"Participant receives two tablets, one containing Norco and one containing placebo~Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam"
11329692|NCT03447730|BG000|Baseline|Part 1: SYNB1020|Part 1 comprised a sentinel open-label cohort of subjects enrolled sequentially to receive SYNB1020, which was administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329693|NCT03447730|BG001|Baseline|Part 2: SYNB1020|Subjects randomized to receive SYNB1020 in Part 2 received SYNB1020 administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329694|NCT03447730|BG002|Baseline|Part 2: Placebo|Subjects randomized to receive control in Part 2 received matching placebo (100 mL masking solution) administered orally TID given immediately after meals from Days 1 through 6.
11329695|NCT03447730|BG003|Baseline|Total|Total of all reporting groups
11329696|NCT03447730|FG000|Participant Flow|Part 1: SYNB1020|Part 1 comprised a sentinel open-label cohort of subjects enrolled sequentially to receive SYNB1020, which was administered orally at a dose of 5 × 10^11 colony-forming units (CFU) 3 times daily (TID) given immediately after meals from Days 1 through 6.
11329697|NCT03447730|FG001|Participant Flow|Part 2: SYNB1020|Subjects randomized to receive SYNB1020 in Part 2 received SYNB1020 administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329698|NCT03447730|FG002|Participant Flow|Part 2: Placebo|Subjects randomized to receive control in Part 2 received matching placebo (100 mL masking solution) administered orally TID given immediately after meals from Days 1 through 6.
11329699|NCT03447730|OG000|Outcome|Part 1: SYNB1020|Part 1 comprised a sentinel open-label cohort of subjects enrolled sequentially to receive SYNB1020, which was administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329700|NCT03447730|OG001|Outcome|Part 2: SYNB1020|Subjects randomized to receive SYNB1020 in Part 2 received SYNB1020 administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329701|NCT03447730|OG002|Outcome|Part 2: Placebo|Subjects randomized to receive control in Part 2 received matching placebo (100 mL masking solution) administered orally TID given immediately after meals from Days 1 through 6.
11329702|NCT03447730|EG000|Reported Event|Part 1: SYNB1020|Part 1 comprised a sentinel open-label cohort of subjects enrolled sequentially to receive SYNB1020, which was administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329703|NCT03447730|EG001|Reported Event|Part 2: SYNB1020|Subjects randomized to receive SYNB1020 in Part 2 received SYNB1020 administered orally at a dose of 5 × 10^11 CFU TID given immediately after meals from Days 1 through 6.
11329704|NCT03447730|EG002|Reported Event|Part 2: Placebo|Subjects randomized to receive control in Part 2 received matching placebo (100 mL masking solution) administered orally TID given immediately after meals from Days 1 through 6.
11329705|NCT03447821|BG000|Baseline|400 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.~400 mg Rifamycin SV dosage"
11329706|NCT03447821|BG001|Baseline|800 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.~800 mg Rifamycin SV dosage"
11329707|NCT03447821|BG002|Baseline|1200 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.~1200 mg Rifamycin SV dosage"
11329708|NCT03447821|BG003|Baseline|Total|Total of all reporting groups
11329709|NCT03447821|FG000|Participant Flow|400 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.~400 mg Rifamycin SV dosage"
11329710|NCT03447821|FG001|Participant Flow|800 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.~800 mg Rifamycin SV dosage"
11329711|NCT03447821|FG002|Participant Flow|1200 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.~1200 mg Rifamycin SV dosage"
11329712|NCT03447821|OG000|Outcome|400 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.~400 mg Rifamycin SV dosage"
11329713|NCT03447821|OG001|Outcome|800 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.~800 mg Rifamycin SV dosage"
11329714|NCT03447821|OG002|Outcome|1200 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.~1200 mg Rifamycin SV dosage"
11329715|NCT03447821|EG000|Reported Event|400 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.~400 mg Rifamycin SV dosage"
11329716|NCT03447821|EG001|Reported Event|800 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.~800 mg Rifamycin SV dosage"
11329717|NCT03447821|EG002|Reported Event|1200 mg Rifamycin SV Dosage|"Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.~1200 mg Rifamycin SV dosage"
11329718|NCT03448068|BG000|Baseline|Ketamine Therapy|Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours
11329719|NCT03448068|BG001|Baseline|Standard Therapy|Subjects received standard of care anesthesia
11329720|NCT03448068|BG002|Baseline|Total|Total of all reporting groups
11329721|NCT03448068|FG000|Participant Flow|Ketamine Therapy|Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours
11329722|NCT03448068|FG001|Participant Flow|Standard Therapy|Subjects received standard of care anesthesia
11329723|NCT03448068|OG000|Outcome|Ketamine Therapy|Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours
11329724|NCT03448068|OG001|Outcome|Standard Therapy|Subjects received standard of care anesthesia
11329725|NCT03448068|EG000|Reported Event|Ketamine Therapy|Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours
11329726|NCT03448068|EG001|Reported Event|Standard Therapy|Subjects received standard of care anesthesia
11329727|NCT03448224|BG000|Baseline|Group I (Web-based Indoor Tanning Intervention)|"Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.~Questionnaire Administration: Questionnaire~Internet-Based Intervention: Intervention"
11329728|NCT03448224|BG001|Baseline|Group II (Wait-list)|"Participants are placed on wait-list and receive full intervention after follow-up.~Questionnaire Administration: Questionnaire"
11329729|NCT03448224|BG002|Baseline|Total|Total of all reporting groups
11329730|NCT03448224|FG000|Participant Flow|Group I (Web-based Indoor Tanning Intervention)|"Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.~Questionnaire Administration: Questionnaire~Internet-Based Intervention: Intervention"
11329731|NCT03448224|FG001|Participant Flow|Group II (Wait-list)|"Participants are placed on wait-list and receive full intervention after follow-up.~Questionnaire Administration: Questionnaire"
11329732|NCT03448224|OG000|Outcome|Group I (Web-based Indoor Tanning Intervention)|"Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.~Questionnaire Administration: Questionnaire~Internet-Based Intervention: Intervention"
11329733|NCT03448224|OG001|Outcome|Group II (Wait-list)|"Participants are placed on wait-list and receive full intervention after follow-up.~Questionnaire Administration: Questionnaire"
11329734|NCT03448224|EG000|Reported Event|Group I (Web-based Indoor Tanning Intervention)|"Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.~Questionnaire Administration: Questionnaire~Internet-Based Intervention: Intervention"
11329735|NCT03448224|EG001|Reported Event|Group II (Wait-list)|"Participants are placed on wait-list and may receive full intervention after follow-up.~Questionnaire Administration: Questionnaire"
11329736|NCT03448406|BG000|Baseline|Placebo|1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%).
11329737|NCT03448406|BG001|Baseline|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%).
11329738|NCT03448406|BG002|Baseline|Total|Total of all reporting groups
11329739|NCT03448406|FG000|Participant Flow|Placebo|1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%).
11329740|NCT03448406|FG001|Participant Flow|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%).
11329741|NCT03448406|OG000|Outcome|Placebo|1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%).
11329742|NCT03448406|OG001|Outcome|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%).
11329743|NCT03448406|EG000|Reported Event|Placebo|1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%).
11329744|NCT03448406|EG001|Reported Event|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%).
11329745|NCT03448419|BG000|Baseline|Placebo|1 film-coated tablet of Placebo matching empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329746|NCT03448419|BG001|Baseline|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329747|NCT03448419|BG002|Baseline|Total|Total of all reporting groups
11329748|NCT03448419|FG000|Participant Flow|Placebo|1 film-coated tablet of Placebo matching empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329749|NCT03448419|FG001|Participant Flow|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329750|NCT03448419|OG000|Outcome|Placebo|1 film-coated tablet of Placebo matching empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329751|NCT03448419|OG001|Outcome|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329752|NCT03448419|OG000|Outcome|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329753|NCT03448419|OG001|Outcome|Placebo|1 film-coated tablet of Placebo matching empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329754|NCT03448419|EG000|Reported Event|Placebo|1 film-coated tablet of Placebo matching empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329755|NCT03448419|EG001|Reported Event|10 mg Empagliflozin|1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).
11329756|NCT03448536|BG000|Baseline|Naproxen Sodium : Acetaminophen|Participants received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2
11329757|NCT03448536|BG001|Baseline|Acetaminophen : Naproxen Sodium|Participants received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
11329758|NCT03448536|BG002|Baseline|Total|Total of all reporting groups
11329759|NCT03448536|FG000|Participant Flow|Naproxen Sodium : Acetaminophen|Participants received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2
11329760|NCT03448536|FG001|Participant Flow|Acetaminophen : Naproxen Sodium|Participants received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
11329761|NCT03448536|OG000|Outcome|Naproxen Sodium|Participants received one single oral dose of 440 mg naproxen sodium
11329762|NCT03448536|OG001|Outcome|Acetaminophen|Participants received one single oral dose of 1000 mg acetaminophen
11329763|NCT03448536|EG000|Reported Event|Naproxen Sodium|Participants received one single oral dose of 440 mg naproxen sodium (safety population per treatment received)
11329764|NCT03448536|EG001|Reported Event|Acetaminophen|Participants received one single oral dose of 1000 mg acetaminophen (safety population per treatment received)
11329765|NCT03449030|BG000|Baseline|Part A: TAK-164 0.004 mg/kg|TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329766|NCT03449030|BG001|Baseline|Part A: TAK-164 0.008 mg/kg|TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329767|NCT03449030|BG002|Baseline|Part A: TAK-164 0.016 mg/kg|TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329768|NCT03449030|BG003|Baseline|Part A: TAK-164 0.032 mg/kg|TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329769|NCT03449030|BG004|Baseline|Part A: TAK-164 0.064 mg/kg|TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329770|NCT03449030|BG005|Baseline|Part A: TAK-164 0.12 mg/kg|TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329771|NCT03449030|BG006|Baseline|Part A: TAK-164 0.16 mg/kg|TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329772|NCT03449030|BG007|Baseline|Part A: TAK-164 0.19 mg/kg|TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329773|NCT03449030|BG008|Baseline|Part A: TAK-164 0.25 mg/kg|TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329774|NCT03449030|BG009|Baseline|Part A: TAK-164 0.32 mg/kg|TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329775|NCT03449030|BG010|Baseline|Total|Total of all reporting groups
11329776|NCT03449030|FG000|Participant Flow|Part A: TAK-164 0.004 mg/kg|TAK-164 0.004 milligram per kilogram (mg/kg), intravenous infusion, on Day 1 of each 21-day treatment cycle until progressive disease (PD), unacceptable toxicity or discontinuation by participant.
11329777|NCT03449030|FG001|Participant Flow|Part A: TAK-164 0.008 mg/kg|TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329778|NCT03449030|FG002|Participant Flow|Part A: TAK-164 0.016 mg/kg|TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329779|NCT03449030|FG003|Participant Flow|Part A: TAK-164 0.032 mg/kg|TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329780|NCT03449030|FG004|Participant Flow|Part A: TAK-164 0.064 mg/kg|TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329781|NCT03449030|FG005|Participant Flow|Part A: TAK-164 0.12 mg/kg|TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329782|NCT03449030|FG006|Participant Flow|Part A: TAK-164 0.16 mg/kg|TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329783|NCT03449030|FG007|Participant Flow|Part A: TAK-164 0.19 mg/kg|TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329784|NCT03449030|FG008|Participant Flow|Part A: TAK-164 0.25 mg/kg|TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329785|NCT03449030|FG009|Participant Flow|Part A: TAK-164 0.32 mg/kg|TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329786|NCT03449030|OG000|Outcome|Part A: TAK-164 0.004 mg/kg|TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329787|NCT03449030|OG001|Outcome|Part A: TAK-164 0.008 mg/kg|TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329788|NCT03449030|OG002|Outcome|Part A: TAK-164 0.016 mg/kg|TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329789|NCT03449030|OG003|Outcome|Part A: TAK-164 0.032 mg/kg|TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329790|NCT03449030|OG004|Outcome|Part A: TAK-164 0.064 mg/kg|TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329791|NCT03449030|OG005|Outcome|Part A: TAK-164 0.12 mg/kg|TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329792|NCT03449030|OG006|Outcome|Part A: TAK-164 0.16 mg/kg|TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329793|NCT03449030|OG007|Outcome|Part A: TAK-164 0.19 mg/kg|TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329794|NCT03449030|OG008|Outcome|Part A: TAK-164 0.25 mg/kg|TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329795|NCT03449030|OG009|Outcome|Part A: TAK-164 0.32 mg/kg|TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329796|NCT03449030|OG000|Outcome|Part A: TAK-164|TAK-164 0.004, 0.008, 0.016, 0.032, 0.064, 0.12, 0.16, 0.19, 0.25 or 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329797|NCT03449030|EG000|Reported Event|Part A: TAK-164 0.004 mg/kg|TAK-164 0.004 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329798|NCT03449030|EG001|Reported Event|Part A: TAK-164 0.008 mg/kg|TAK-164 0.008 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329799|NCT03449030|EG002|Reported Event|Part A: TAK-164 0.016 mg/kg|TAK-164 0.016 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329800|NCT03449030|EG003|Reported Event|Part A: TAK-164 0.032 mg/kg|TAK-164 0.032 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329801|NCT03449030|EG004|Reported Event|Part A: TAK-164 0.064 mg/kg|TAK-164 0.064 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329802|NCT03449030|EG005|Reported Event|Part A: TAK-164 0.12 mg/kg|TAK-164 0.12 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329803|NCT03449030|EG006|Reported Event|Part A: TAK-164 0.16 mg/kg|TAK-164 0.16 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329804|NCT03449030|EG007|Reported Event|Part A: TAK-164 0.19 mg/kg|TAK-164 0.19 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329805|NCT03449030|EG008|Reported Event|Part A: TAK-164 0.25 mg/kg|TAK-164 0.25 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329806|NCT03449030|EG009|Reported Event|Part A: TAK-164 0.32 mg/kg|TAK-164 0.32 mg/kg, intravenous infusion, on Day 1 of each 21-day treatment cycle until PD, unacceptable toxicity or discontinuation by participant.
11329807|NCT03449134|BG000|Baseline|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
11329808|NCT03449134|BG001|Baseline|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
11329809|NCT03449134|BG002|Baseline|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
11329810|NCT03449134|BG003|Baseline|Total|Total of all reporting groups
11329811|NCT03449134|FG000|Participant Flow|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
11329812|NCT03449134|FG001|Participant Flow|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
11329813|NCT03449134|FG002|Participant Flow|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
11329814|NCT03449134|OG000|Outcome|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
11329815|NCT03449134|OG001|Outcome|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
11329816|NCT03449134|OG002|Outcome|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
11329817|NCT03449134|EG000|Reported Event|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
11329818|NCT03449134|EG001|Reported Event|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
11329819|NCT03449134|EG002|Reported Event|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
11329820|NCT03449134|EG003|Reported Event|Placebo: Off-Tx|Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329821|NCT03449134|EG004|Reported Event|Gefapixant 15 mg BID: Off-Tx|Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329822|NCT03449134|EG005|Reported Event|Gefapixant 45 mg BID: Off-Tx|Participants previously treated with gefapixant 45 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329823|NCT03449147|BG000|Baseline|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
11329824|NCT03449147|BG001|Baseline|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
11329825|NCT03449147|BG002|Baseline|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
11329826|NCT03449147|BG003|Baseline|Total|Total of all reporting groups
11329827|NCT03449147|FG000|Participant Flow|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
11329828|NCT03449147|FG001|Participant Flow|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
11329829|NCT03449147|FG002|Participant Flow|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
11329830|NCT03449147|OG000|Outcome|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
11329831|NCT03449147|OG001|Outcome|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
11329832|NCT03449147|OG002|Outcome|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
11329833|NCT03449147|OG002|Outcome|Gefapixant 45 mg|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
11329834|NCT03449147|EG000|Reported Event|Placebo|Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
11329835|NCT03449147|EG001|Reported Event|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
11329836|NCT03449147|EG002|Reported Event|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
11329837|NCT03449147|EG003|Reported Event|Placebo: Off Tx|Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329838|NCT03449147|EG004|Reported Event|Gefapixant 15 mg BID: Off Tx|Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329839|NCT03449147|EG005|Reported Event|Gefapixant 45 mg BID: Off Tx|Participants previously treated with gefapixant BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
11329840|NCT03449342|BG000|Baseline|Adolescents (12 - <18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329841|NCT03449342|BG001|Baseline|Adults (≥18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329842|NCT03449342|BG002|Baseline|Total|Total of all reporting groups
11335749|NCT03555890|BG001|Baseline|Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11329843|NCT03449342|FG000|Participant Flow|Adolescents (12 - <18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329844|NCT03449342|FG001|Participant Flow|Adults (≥18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329845|NCT03449342|OG000|Outcome|Adolescents (12 - <18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329846|NCT03449342|OG001|Outcome|Adults (≥18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329847|NCT03449342|EG000|Reported Event|Adolescents (12 - <18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329848|NCT03449342|EG001|Reported Event|Adults (>=18 Years)|Participants were to receive prophylactic (preventive) treatment of turoctocog alfa as intravenous (i.v.) injections at a frequency of 'every second day' or '3 times a week' at a dose in the range of 20-50 IU/kg at the investigator's discretion. Dosing for prophylaxis was according to the approved prescribing information. The total treatment duration for each participant was 8 weeks. Bleeds were treated with one or more turoctocog alfa intravenous (i.v.) bolus injections. The individual dose levels were decided by the investigator based on recommendations from the World Federation of Hemophilia (WFH). Participants who underwent surgery were treated with turoctocog alfa according to WFH recommendations.
11329849|NCT03449433|BG000|Baseline|T1DM Cohort|All randomized participants with T1DM participants who received at least 1 dose of study drug.
11329850|NCT03449433|BG001|Baseline|Healthy Participants|All healthy participants.
11329851|NCT03449433|BG002|Baseline|Total|Total of all reporting groups
11329852|NCT03449433|FG000|Participant Flow|Type 1 Diabetes Mellitus (T1DM) Cohort 1|"Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin n Aspart (Fiasp®) administered SC Period 3:Insulin Lispro (Humalog®) administered SC Period 4: Insulin Aspart (NovoRapid®) administered SC~with 21 hours between doses"
11329853|NCT03449433|FG001|Participant Flow|T1DM Cohort 2|"Period 1: Insulin Aspart (Fiasp®) administered SC Period 2: LY900014 administered subcutaneously (SC) Period 3: Insulin Aspart (NovoRapid®) administered SC Period 4:Insulin Lispro (Humalog®) administered SC~with 21 hours between doses"
11329854|NCT03449433|FG002|Participant Flow|T1DM Cohort 3|"Period 1: Insulin Aspart (NovoRapid®) administered SC Period 2:Insulin Lispro (Humalog®) administered SC Period 3: insulin Aspart (Fiasp®) administered SC Period 4: LY900014 administered subcutaneously (SC)~with 21 hours between doses"
11329855|NCT03449433|FG003|Participant Flow|T1DM Cohort 4|"Period 1:Insulin Lispro (Humalog®) administered SC Period 2: Insulin Aspart (NovoRapid®) administered SC Period 3: LY900014 administered SC Period 4: insulin Aspart (Fiasp®) administered SC~with 21 hours between doses"
11329856|NCT03449433|FG004|Participant Flow|Healthy Participants|Healthy participant cohort did not receive any dose of study drug.
11329857|NCT03449433|OG000|Outcome|LY900014|T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014
11329858|NCT03449433|OG001|Outcome|Insulin Lispro (Humalog®)|T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog)
11329859|NCT03449433|OG002|Outcome|Insulin Aspart (NovoRapid®)|T1DM participants received a single,individualized, SC dose of insulin
11329860|NCT03449433|OG003|Outcome|Insulin Aspart (Fiasp®)|T1DM participants received a single,individualized, SC dose of insulin aspart
11329861|NCT03449433|OG001|Outcome|Insulin Lispro (Humalog®)|T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog®) T1DM participants
11329862|NCT03449433|OG002|Outcome|Insulin Aspart (NovoRapid®)|T1DM participants received a single,individualized, SC dose of insulin aspart
11329863|NCT03449433|OG004|Outcome|Healthy Participants|Healthy participants, cohort did not receive study drug.
11329864|NCT03449433|EG000|Reported Event|LY900014|T1DM participants received a single, subcutaneous (SC) dose of LY900014.
11329865|NCT03449433|EG001|Reported Event|Insulin Lispro (Humalog®)|T1DM participants received a single, SC dose of insulin lispro (Humalog®).
11329866|NCT03449433|EG002|Reported Event|Insulin Aspart (Fiasp®)|T1DM participants received a single, SC dose of insulin aspart (Fiasp®).
11329867|NCT03449433|EG003|Reported Event|Insulin Aspart (NovoRapid®)|T1DM participants received a single, SC dose of insulin aspart (NovoRapid®).
11329868|NCT03449433|EG004|Reported Event|Healthy Participants|Healthy subject cohort, cohort did not receive any dose of study drug.
11329869|NCT03449446|BG000|Baseline|Selonsertib|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329870|NCT03449446|BG001|Baseline|Firsocostat|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329871|NCT03449446|BG002|Baseline|Cilofexor|Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329872|NCT03449446|BG003|Baseline|SEL + FIR|Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329873|NCT03449446|BG004|Baseline|SEL + CILO|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329874|NCT03449446|BG005|Baseline|FIR + CILO|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329875|NCT03449446|BG006|Baseline|Placebo|Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329876|NCT03449446|BG007|Baseline|Total|Total of all reporting groups
11329877|NCT03449446|FG000|Participant Flow|Selonsertib|Participants received selonsertib (SEL) 18 mg tablet + placebo to match firsocostat (FIR) 20 mg tablet + placebo to match cilofexor (CILO) 30 mg tablet orally once daily for 48 weeks.
11329878|NCT03449446|FG001|Participant Flow|Firsocostat|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329879|NCT03449446|FG002|Participant Flow|Cilofexor|Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329880|NCT03449446|FG003|Participant Flow|SEL + FIR|Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329881|NCT03449446|FG004|Participant Flow|SEL + CILO|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329882|NCT03449446|FG005|Participant Flow|FIR + CILO|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329883|NCT03449446|FG006|Participant Flow|Placebo|Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329884|NCT03449446|OG000|Outcome|Selonsertib|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329885|NCT03449446|OG001|Outcome|Firsocostat|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329886|NCT03449446|OG002|Outcome|Cilofexor|Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329887|NCT03449446|OG003|Outcome|SEL + FIR|Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329888|NCT03449446|OG004|Outcome|SEL + CILO|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329889|NCT03449446|OG005|Outcome|FIR + CILO|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329890|NCT03449446|OG006|Outcome|Placebo|Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329891|NCT03449446|EG000|Reported Event|Selonsertib|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329892|NCT03449446|EG001|Reported Event|Firsocostat|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329893|NCT03449446|EG002|Reported Event|Cilofexor|Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329894|NCT03449446|EG003|Reported Event|SEL + FIR|Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329895|NCT03449446|EG004|Reported Event|SEL + CILO|Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329896|NCT03449446|EG005|Reported Event|FIR + CILO|Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
11329897|NCT03449446|EG006|Reported Event|Placebo|Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
11329898|NCT03449979|BG000|Baseline|Alpha Stimulation in Participants in a Depressive Episode|"Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329899|NCT03449979|BG001|Baseline|Sham Stimulation in Participants in a Depressive Episode|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329900|NCT03449979|BG002|Baseline|Alpha Stimulation in Healthy Participants|"Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329901|NCT03449979|BG003|Baseline|Sham Stimulation in Healthy Participants|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329902|NCT03449979|BG004|Baseline|Total|Total of all reporting groups
11329903|NCT03449979|FG000|Participant Flow|Alpha Stimulation in Participants in a Depressive Episode|"Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329904|NCT03449979|FG001|Participant Flow|Sham Stimulation in Participants in a Depressive Episode|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329905|NCT03449979|FG002|Participant Flow|Alpha Stimulation in Healthy Participants|"Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329906|NCT03449979|FG003|Participant Flow|Sham Stimulation in Healthy Participants|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329907|NCT03449979|OG000|Outcome|Alpha Stimulation in Participants in a Depressive Episode|"Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329908|NCT03449979|OG001|Outcome|Sham Stimulation in Participants in a Depressive Episode|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329909|NCT03449979|OG002|Outcome|Alpha Stimulation in Healthy Participants|"Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329910|NCT03449979|OG003|Outcome|Sham Stimulation in Healthy Participants|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329911|NCT03449979|EG000|Reported Event|Alpha Stimulation in Patients in a Depressive Episode|"Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329912|NCT03449979|EG001|Reported Event|Sham Stimulation in Patients in a Depressive Episode|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11335750|NCT03555890|BG002|Baseline|Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11329913|NCT03449979|EG002|Reported Event|Alpha Stimulation in Healthy Participants|"Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.~XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied."
11329914|NCT03449979|EG003|Reported Event|Sham Stimulation in Healthy Participants|"Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.~XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session."
11329915|NCT03450070|BG000|Baseline|Test Panel|Light Therapy Mask Cream
11329916|NCT03450070|FG000|Participant Flow|Test Panel|Light Therapy Mask Cream
11329917|NCT03450070|OG000|Outcome|Test Panel|Light Therapy Mask Cream
11329918|NCT03450070|EG000|Reported Event|Test Panel|Light Therapy Mask Cream
11329919|NCT03450083|BG000|Baseline|Benralizumab Treatment Group|"Benralizumab Active treatment group delivered subcutaneously~Benralizumab: 30mg Benralizumab will be delivered subcutaneously"
11329920|NCT03450083|BG001|Baseline|Placebo Group|"Placebo treatment group delivered subcutaneously~Placebo: Subcutaneous placebo injection"
11329921|NCT03450083|BG002|Baseline|Total|Total of all reporting groups
11329922|NCT03450083|FG000|Participant Flow|Benralizumab Treatment Group|"Benralizumab Active treatment group delivered subcutaneously~Benralizumab: 30mg Benralizumab will be delivered subcutaneously"
11329923|NCT03450083|FG001|Participant Flow|Placebo Group|"Placebo treatment group delivered subcutaneously~Placebo: Subcutaneous placebo injection"
11329924|NCT03450083|OG000|Outcome|Benralizumab Treatment Group|"Benralizumab Active treatment group delivered subcutaneously~Benralizumab: 30mg Benralizumab will be delivered subcutaneously"
11329925|NCT03450083|OG001|Outcome|Placebo Group|"Placebo treatment group delivered subcutaneously~Placebo: Subcutaneous placebo injection"
11329926|NCT03450083|EG000|Reported Event|Benralizumab Treatment Group|"Benralizumab Active treatment group delivered subcutaneously~Benralizumab: 30mg Benralizumab will be delivered subcutaneously"
11329927|NCT03450083|EG001|Reported Event|Placebo Group|"Placebo treatment group delivered subcutaneously~Placebo: Subcutaneous placebo injection"
11329928|NCT03450369|BG000|Baseline|Low Dose|10^4 CFU/cm^2 NB01
11329929|NCT03450369|BG001|Baseline|High Dose|10^5 CFU/cm^2 NB01
11329930|NCT03450369|BG002|Baseline|Total|Total of all reporting groups
11329931|NCT03450369|FG000|Participant Flow|Low Dose|10^4 CFU/cm^2 NB01 colony forming unit (CFU)
11329932|NCT03450369|FG001|Participant Flow|High Dose|10^5 CFU/cm^2 NB01 colony forming unit (CFU)
11329933|NCT03450369|OG000|Outcome|Low Dose|10^4 CFU/cm^2 NB01
11329934|NCT03450369|OG001|Outcome|High Dose|10^5 CFU/cm^2 NB01
11329935|NCT03450369|EG000|Reported Event|Low Dose|10^4 CFU/cm^2 NB01
11329936|NCT03450369|EG001|Reported Event|High Dose|10^5 CFU/cm^2 NB01
11329937|NCT03450915|BG000|Baseline|M-001|"Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.~M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses."
11329938|NCT03450915|BG001|Baseline|Saline|"Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.~Saline: 0.9% sodium chloride (NaCl)"
11329939|NCT03450915|BG002|Baseline|Total|Total of all reporting groups
11329940|NCT03450915|FG000|Participant Flow|M-001|"Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.~M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses."
11329941|NCT03450915|FG001|Participant Flow|Saline|"Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.~Saline: 0.9% sodium chloride (NaCl)"
11329942|NCT03450915|OG000|Outcome|M-001|"Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.~M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses."
11329943|NCT03450915|OG001|Outcome|Saline|"Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.~Saline: 0.9% sodium chloride (NaCl)"
11329944|NCT03450915|EG000|Reported Event|M-001|"Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.~M-001: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses."
11329945|NCT03450915|EG001|Reported Event|Saline|"Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.~Saline: 0.9% sodium chloride (NaCl)"
11329946|NCT03451071|BG000|Baseline|Gardasil9|Gardasil9: Gardasil 9
11329947|NCT03451071|FG000|Participant Flow|Gardasil9|Gardasil9: Gardasil 9
11329948|NCT03451071|OG000|Outcome|Gardasil9|Gardasil9: Gardasil 9
11329949|NCT03451071|EG000|Reported Event|Gardasil9|Gardasil9: Gardasil 9
11329950|NCT03451084|BG000|Baseline|Part 1: ASLAN003 100mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329951|NCT03451084|BG001|Baseline|Part 1: ASLAN003 200mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329952|NCT03451084|BG002|Baseline|Part 1: ASLAN003 100mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329953|NCT03451084|BG003|Baseline|Part 1: ASLAN003 200mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329954|NCT03451084|BG004|Baseline|Total|Total of all reporting groups
11329955|NCT03451084|FG000|Participant Flow|Part 1: ASLAN003 100mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329956|NCT03451084|FG001|Participant Flow|Part 1: ASLAN003 200mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329957|NCT03451084|FG002|Participant Flow|Part 1: ASLAN003 100mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329958|NCT03451084|FG003|Participant Flow|Part 1: ASLAN003 200mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329959|NCT03451084|OG000|Outcome|Part 1: ASLAN003 100mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329960|NCT03451084|OG001|Outcome|Part 1: ASLAN003 200mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329961|NCT03451084|OG002|Outcome|Part 1: ASLAN003 100mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329962|NCT03451084|OG003|Outcome|Part 1: ASLAN003 200mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329963|NCT03451084|EG000|Reported Event|Part 1: ASLAN003 100mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329964|NCT03451084|EG001|Reported Event|Part 1: ASLAN003 200mg QD|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329965|NCT03451084|EG002|Reported Event|Part 1: ASLAN003 100mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11335751|NCT03555890|BG003|Baseline|Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11329966|NCT03451084|EG003|Reported Event|Part 1: ASLAN003 200mg BID|ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
11329967|NCT03451721|BG000|Baseline|ImageReady™ MR Conditional Defibrillation System|"Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology~Subject must have the ImageReady System as their initial (de novo) defibrillation system implant~ImageReady™ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD"
11329968|NCT03451721|FG000|Participant Flow|ImageReady™ MR Conditional Defibrillation System|"Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology~Subject must have the ImageReady System as their initial (de novo) defibrillation system implant~ImageReady™ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD"
11329969|NCT03451721|OG000|Outcome|ImageReady™ MR Conditional Defibrillation System|"Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology~Subject must have the ImageReady System as their initial (de novo) defibrillation system implant~ImageReady™ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD"
11329970|NCT03451721|EG000|Reported Event|ImageReady™ MR Conditional Defibrillation System|"Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology~Subject must have the ImageReady System as their initial (de novo) defibrillation system implant~ImageReady™ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD"
11329971|NCT03451773|BG000|Baseline|Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + de-escalating dose of M7824~M7824:500mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329972|NCT03451773|BG001|Baseline|Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + RP2D of M7824~M7824: 1,200mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329973|NCT03451773|BG002|Baseline|Total|Total of all reporting groups
11329974|NCT03451773|FG000|Participant Flow|Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + de-escalating dose of M7824~M7824:500mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329975|NCT03451773|FG001|Participant Flow|Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + RP2D of M7824~M7824: 1,200mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329976|NCT03451773|OG000|Outcome|Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + de-escalating dose of M7824~M7824:500mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329977|NCT03451773|OG001|Outcome|Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + RP2D of M7824~M7824: 1,200mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329978|NCT03451773|OG000|Outcome|All Participants|All participants in Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C), and Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)
11329979|NCT03451773|EG000|Reported Event|Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + de-escalating dose of M7824~M7824:500mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329980|NCT03451773|EG001|Reported Event|Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)|"Gemcitabine (dose based on genetic testing results) + RP2D of M7824~M7824: 1,200mg every 2 weeks by intravenous (IV) infusion~Gemcitabine: Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy"
11329981|NCT03452033|BG000|Baseline|H-1337 0.06%|H-1337 Ophthalmic Solution Concentration 0.06%
10841033|NCT00234832|OG005|Outcome|CV Only Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
11329982|NCT03452033|BG001|Baseline|H-1337 0.2%|H-1337 Ophthalmic Solution Concentration 0.2%
11329983|NCT03452033|BG002|Baseline|H-1337 0.6%|H-1337 Ophthalmic Solution Concentration 0.6%
11329984|NCT03452033|BG003|Baseline|Vehicle|Vehicle (contains all components of the active formulation with the exception of H-1337)
11329985|NCT03452033|BG004|Baseline|Total|Total of all reporting groups
11329986|NCT03452033|FG000|Participant Flow|H-1337 0.06%|H-1337 Ophthalmic Solution Concentration 0.06%
11329987|NCT03452033|FG001|Participant Flow|H-1337 0.2%|H-1337 Ophthalmic Solution Concentration 0.2%
11329988|NCT03452033|FG002|Participant Flow|H-1337 0.6%|H-1337 Ophthalmic Solution Concentration 0.6%
11329989|NCT03452033|FG003|Participant Flow|Vehicle|Vehicle (contains all components of the active formulation with the exception of H-1337)
11329990|NCT03452033|OG000|Outcome|H-1337 0.06%|H-1337 Ophthalmic Solution 0.06%
11329991|NCT03452033|OG001|Outcome|H-1337 0.2%|H-1337 Ophthalmic Solution 0.2%
11329992|NCT03452033|OG002|Outcome|H-1337 0.6%|H-1337 Ophthalmic Solution 0.6%
11329993|NCT03452033|OG003|Outcome|Vehicle|Vehicle (contains all components of the active formulation with the exception of H-1337)
11329994|NCT03452033|OG000|Outcome|H-1337 0.06%|H-1337 Ophthalmic Solution Concentration 0.06%
11329995|NCT03452033|OG001|Outcome|H-1337 0.2%|H-1337 Ophthalmic Solution Concentration 0.2%
11329996|NCT03452033|OG002|Outcome|H-1337 0.6%|H-1337 Ophthalmic Solution Concentration 0.6%
11329997|NCT03452033|EG000|Reported Event|H-1337 0.06%|H-1337 Ophthalmic Solution Concentration 0.06%
11329998|NCT03452033|EG001|Reported Event|H-1337 0.2%|H-1337 Ophthalmic Solution Concentration 0.2%
11329999|NCT03452033|EG002|Reported Event|H-1337 0.6%|H-1337 Ophthalmic Solution Concentration 0.6%
11330000|NCT03452033|EG003|Reported Event|Vehicle|Vehicle (contains all components of the active formulation with the exception of H-1337)
11330001|NCT03452176|BG000|Baseline|Scrambler|"This arm will receive the Scrambler intervention for 1 hour daily x10 days.~Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy."
11330002|NCT03452176|BG001|Baseline|Sham-Control|"This arm will receive the Sham-Control intervention for 1 hour daily x10 days.~Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy."
11330003|NCT03452176|BG002|Baseline|Total|Total of all reporting groups
11330004|NCT03452176|FG000|Participant Flow|Scrambler|"This arm will receive the Scrambler intervention for 1 hour daily x10 days.~Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy."
11330005|NCT03452176|FG001|Participant Flow|Sham-Control|"This arm will receive the Sham-Control intervention for 1 hour daily x10 days.~Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy."
11330006|NCT03452176|OG000|Outcome|Scrambler|"This arm will receive the Scrambler intervention for 1 hour daily x10 days.~Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy."
11330007|NCT03452176|OG001|Outcome|Sham-Control|"This arm will receive the Sham-Control intervention for 1 hour daily x10 days.~Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy."
11330008|NCT03452176|OG000|Outcome|Scrambler Pre|Median NRS scores prior to receiving 10-day treatment course
11330009|NCT03452176|OG001|Outcome|Scrambler Post|Median NRS scores directly following 10-day treatment course to receiving treatment
11330010|NCT03452176|OG002|Outcome|Sham Pre|Median NRS scores prior to receiving 10-day sham
11330011|NCT03452176|OG003|Outcome|Sham Post|Median NRS scores directly following 10-day sham
11330012|NCT03452176|OG000|Outcome|Scrambler 30-day Post|Median NRS scores 30-day post-treatment
11330013|NCT03452176|OG001|Outcome|Sham 30-day Post|Median NRS scores 30-day post sham
11330014|NCT03452176|OG000|Outcome|Scrambler 60-day Post|Median NRS scores 60-day post-treatment
11330015|NCT03452176|OG001|Outcome|Sham 60-day Post|Median NRS scores 60-day post sham
11330016|NCT03452176|EG000|Reported Event|Scrambler|"This arm will receive the Scrambler intervention for 1 hour daily x10 days.~Scrambler: Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy."
11330017|NCT03452176|EG001|Reported Event|Sham-Control|"This arm will receive the Sham-Control intervention for 1 hour daily x10 days.~Scrambler Sham Control: Sham control should be indistinguishable to the participants from experimental Scrambler therapy."
11330018|NCT03452189|BG000|Baseline|Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months)|Total cohort
11330019|NCT03452189|FG000|Participant Flow|250mg of Oral Vancomycin First, Then Placebo|250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).
11330020|NCT03452189|FG001|Participant Flow|Placebo First, Then 250mg of Oral Vancomycin|Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
11330021|NCT03452189|OG000|Outcome|250mg of Oral Vancomycin First, Then Placebo|250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).
11330022|NCT03452189|OG001|Outcome|Placebo First, Then 250mg of Oral Vancomycin|Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
11330023|NCT03452189|EG000|Reported Event|250mg of Oral Vancomycin First|"After 3 months, initial experimental group will be switched to placebo for 3 months.~Vancomycin: Oral vancomycin 250mg capsules~Placebo: Placebo Pills distributed by Research Pharmacy labeled placebo."
11330024|NCT03452189|EG001|Reported Event|Placebo First|"After three months, the control group will be crossed over to weekly oral vancomycin (250mg)~Vancomycin: Oral vancomycin 250mg capsules~Placebo: Placebo Pills distributed by Research Pharmacy labeled placebo."
11330025|NCT03452371|BG000|Baseline|Enhanced Traditional Care|"Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support.~Enhanced Traditional Care: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation."
11330026|NCT03452371|BG001|Baseline|Patient Navigation Intervention|"Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months.~Patient Navigation: Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing."
11330027|NCT03452371|BG002|Baseline|Total|Total of all reporting groups
11330028|NCT03452371|FG000|Participant Flow|Enhanced Traditional Care|"Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support.~Enhanced Traditional Care: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation."
11330029|NCT03452371|FG001|Participant Flow|Patient Navigation Intervention|"Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months.~Patient Navigation: Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing."
11330030|NCT03452371|OG000|Outcome|Enhanced Traditional Care|"Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support.~Enhanced Traditional Care: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation."
11330031|NCT03452371|OG001|Outcome|Patient Navigation Intervention|"Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months.~Patient Navigation: Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing."
11330032|NCT03452371|EG000|Reported Event|Enhanced Traditional Care|"Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support.~Enhanced Traditional Care: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation."
11330033|NCT03452371|EG001|Reported Event|Patient Navigation Intervention|"Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months.~Patient Navigation: Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing."
11330034|NCT03452527|BG000|Baseline|ICON-1 Maintenance Therapy|"ICON-1 maintenance therapy after initial aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330035|NCT03452527|BG001|Baseline|ICON-1 Combination Therapy|"ICON-1 combination therapy with aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330036|NCT03452527|BG002|Baseline|Total|Total of all reporting groups
11330037|NCT03452527|FG000|Participant Flow|ICON-1 Maintenance Therapy|"ICON-1 maintenance therapy after initial aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330038|NCT03452527|FG001|Participant Flow|ICON-1 Combination Therapy|"ICON-1 combination therapy with aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330039|NCT03452527|OG000|Outcome|ICON-1 Maintenance Therapy|"ICON-1 maintenance therapy after initial aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330040|NCT03452527|OG001|Outcome|ICON-1 Combination Therapy|"ICON-1 combination therapy with aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330041|NCT03452527|EG000|Reported Event|ICON-1 Maintenance Therapy|"ICON-1 maintenance therapy after initial aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330042|NCT03452527|EG001|Reported Event|ICON-1 Combination Therapy|"ICON-1 combination therapy with aflibercept treatment~ICON-1: ICON-1 0.6 mg by intravitreal injection~aflibercept: aflibercept 2 mg by intravitreal injection"
11330043|NCT03452943|BG000|Baseline|TEV-50717|Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks.
11330044|NCT03452943|BG001|Baseline|Placebo|Participants received placebo matched to TEV-50717 BID for a total of 12 weeks.
11330045|NCT03452943|BG002|Baseline|Total|Total of all reporting groups
11330046|NCT03452943|FG000|Participant Flow|TEV-50717|Participants received TEV-50717 as oral tablets at a starting dose of 6 milligrams (mg)/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status at baseline. Maximum total daily dose for participants greater than or equal to (≥) 40 kilograms (kg) was 48 mg/day (24 mg twice daily [BID]), 30 to less than (<) 40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks.
11330047|NCT03452943|FG001|Participant Flow|Placebo|Participants received placebo matched to TEV-50717 BID for a total of 12 weeks.
11330048|NCT03452943|OG000|Outcome|TEV-50717|Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks.
11330049|NCT03452943|OG001|Outcome|Placebo|Participants received placebo matched to TEV-50717 BID for a total of 12 weeks.
11330050|NCT03452943|EG000|Reported Event|TEV-50717|Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks.
11330051|NCT03452943|EG001|Reported Event|Placebo|Participants received placebo matched to TEV-50717 BID for a total of 12 weeks.
11330052|NCT03453060|BG000|Baseline|E-WE Thrombin Dose 1|Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
11330053|NCT03453060|BG001|Baseline|E-WE Thrombin Dose 2|Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
11330054|NCT03453060|BG002|Baseline|E-WE Thrombin Dose 3|Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
11330055|NCT03453060|BG003|Baseline|E-WE Thrombin Dose 4|Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
11330056|NCT03453060|BG004|Baseline|Placebo|Participants received a single intravenous dose of placebo.
11330057|NCT03453060|BG005|Baseline|Total|Total of all reporting groups
11330058|NCT03453060|FG000|Participant Flow|E-WE Thrombin Dose 1|Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
11330059|NCT03453060|FG001|Participant Flow|E-WE Thrombin Dose 2|Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
11330060|NCT03453060|FG002|Participant Flow|E-WE Thrombin Dose 3|Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
11330061|NCT03453060|FG003|Participant Flow|E-WE Thrombin Dose 4|Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
11330062|NCT03453060|FG004|Participant Flow|Placebo|Participants received a single intravenous dose of placebo.
11330063|NCT03453060|OG000|Outcome|E-WE Thrombin Dose 1|Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
11330064|NCT03453060|OG001|Outcome|E-WE Thrombin Dose 2|Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
11330065|NCT03453060|OG002|Outcome|E-WE Thrombin Dose 3|Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
11330066|NCT03453060|OG003|Outcome|E-WE Thrombin Dose 4|Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
11330067|NCT03453060|OG004|Outcome|Placebo|Participants received a single intravenous dose of placebo.
11330068|NCT03453060|EG000|Reported Event|E-WE Thrombin Dose 1|Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
11330069|NCT03453060|EG001|Reported Event|E-WE Thrombin Dose 2|Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
11330070|NCT03453060|EG002|Reported Event|E-WE Thrombin Dose 3|Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
11330071|NCT03453060|EG003|Reported Event|E-WE Thrombin Dose 4|Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
11330072|NCT03453060|EG004|Reported Event|Placebo|Participants received a single intravenous dose of placebo.
11330073|NCT03453151|BG000|Baseline|Splanchnic Nerve Block (SNB)|Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
11335752|NCT03555890|BG004|Baseline|Total|Total of all reporting groups
11330074|NCT03453151|FG000|Participant Flow|Splanchnic Nerve Block (SNB)|Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
11330075|NCT03453151|OG000|Outcome|Splanchnic Nerve Block (SNB)|Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
11330076|NCT03453151|EG000|Reported Event|Splanchnic Nerve Block|Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)
11330077|NCT03453515|BG000|Baseline|HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11330078|NCT03453515|BG001|Baseline|Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11330079|NCT03453515|BG002|Baseline|Total|Total of all reporting groups
11330080|NCT03453515|FG000|Participant Flow|HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11330081|NCT03453515|FG001|Participant Flow|Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11330082|NCT03453515|OG000|Outcome|HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11330083|NCT03453515|OG001|Outcome|Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11330084|NCT03453515|EG000|Reported Event|HEART|"Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.~HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills."
11330085|NCT03453515|EG001|Reported Event|Growing Minds|"Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.~Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary."
11330086|NCT03454048|BG000|Baseline|Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 1 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330087|NCT03454048|BG001|Baseline|Group 2 (Cohort A) LD-PIP/LD-PIP2/SP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 2(LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330088|NCT03454048|BG002|Baseline|Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 3 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg)~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11335753|NCT03555890|FG000|Participant Flow|Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)|All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11330089|NCT03454048|BG003|Baseline|Group 4 (Cohort B) LD-PIP/LD-PIP2/SP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 4 (LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330090|NCT03454048|BG004|Baseline|Total|Total of all reporting groups
11330091|NCT03454048|FG000|Participant Flow|Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 1 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330092|NCT03454048|FG001|Participant Flow|Group 2 (Cohort A) LD-PIP/LD-PIP2/SP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 2(LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330093|NCT03454048|FG002|Participant Flow|Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 3 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg)~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330094|NCT03454048|FG003|Participant Flow|Group 4 (Cohort B) LD-PIP/LD-PIP2/SP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 4 (LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330095|NCT03454048|OG000|Outcome|Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 1 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330096|NCT03454048|OG001|Outcome|Group 2 (Cohort A) LD-PIP/LD-PIP2/SP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 2(LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330097|NCT03454048|OG002|Outcome|Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 3 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg)~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11335754|NCT03555890|FG001|Participant Flow|Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11330098|NCT03454048|OG003|Outcome|Group 4 (Cohort B) LD-PIP/LD-PIP2/SP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 4 (LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330099|NCT03454048|OG000|Outcome|Cohort A|Group 1 and 2
11330100|NCT03454048|OG001|Outcome|Cohort B|Group 3 and 4
11330101|NCT03454048|EG000|Reported Event|Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 1 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330102|NCT03454048|EG001|Reported Event|Group 2 (Cohort A) LD-PIP/LD-PIP2/SP|"Cohort A will be subjected to a standard controlled human malaria infection (CHMI) delivered by five Pf-infected mosquitoes. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 2(LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~malaria challenge infection, P. falciparum 3D7: malaria challenge infection by P. falciparum 3D7-infected mosquito bites"
11330103|NCT03454048|EG002|Reported Event|Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 3 (LD-PIP/LD-PIP2/PIP) will be curatively treated with piperaquine (960mg)~Piperaquine (low dose): subcurative regimen (480 mg)~Piperaquine (high dose): Curative regimen (960mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330104|NCT03454048|EG003|Reported Event|Group 4 (Cohort B) LD-PIP/LD-PIP2/SP|"Cohort B will be subjected to a standard blood stage challenge with ~2,800 Pf-infected erythrocytes by intravenous injection. All volunteers will be treated with a single oral subcurative low-dose of piperaquine (LD-PIP, 480 mg, T1). Volunteers will receive a second treatment (T2, LD-PIP2, 480mg) if a recrudescence of asexual parasitemia occurs before day 21 post challenge infection. Volunteers in group 4 (LD-PIP/LD-PIP2/SP) will be curatively treated with sulfadoxine-pyrimethamine (1000mg/50mg).~Piperaquine (low dose): subcurative regimen (480 mg)~Sulfadoxine pyrimethamine: Curative regimen (1000mg/50mg)~Atovaquone Proguanil: Curative regimen (1000/400 mg, for 3 days)~Blood stage malaria challenge infection, P. falciparum 3D7: P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection."
11330105|NCT03454412|BG000|Baseline|Intensive Neurophysiological Rehabilitation|Patients undergoing two-weeks treatment course of Intensive Neurophysiological Rehabilitation
11330106|NCT03454412|FG000|Participant Flow|Intensive Neurophysiological Rehabilitation|Patients undergoing 2 weeks treatment course
11330107|NCT03454412|OG000|Outcome|Intensive Neurophysiological Rehabilitation|Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
11330108|NCT03454412|EG000|Reported Event|Intensive Neurophysiological Rehabilitation|Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation
11330109|NCT03454581|BG000|Baseline|Photobiomodulation Group (PBM)|PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid.
11330110|NCT03454581|BG001|Baseline|Manual Therapy Group (MT)|Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week .
11330111|NCT03454581|BG002|Baseline|Combined Therapy Group (CT)|"Applied the protocols of PBM group and immediately after, to MT group.~."
11330112|NCT03454581|BG003|Baseline|Total|Total of all reporting groups
11330113|NCT03454581|FG000|Participant Flow|Photobiomodulation Group|"Gallium-aluminium-arsenide (GaAlAs) diode laser (MM Optics Recover, São Carlos, São Paulo, Brazil) with a wavelength of 808 nm, punctual contact mode,spot size of 0.03 cm2, power output of 100mW (megawatts), output density of 333 mW∕cm2, energy density of 13.3 J ∕cm2, 40 s exposure time per point, and 4 Joules (J) of total energy per point.~18 individuals~Photobiomodulation: PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid."
11336275|NCT03565068|FG000|Participant Flow|Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg|Healthy participants received MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11330114|NCT03454581|FG001|Participant Flow|Manual Therapy Group (MT)|"At masticatory muscles were performed circular movements, slip and compression with fingers movements. At the temporomandibular joint (TMJ) was performed a caudal distraction with anterior projection, placing the thumb on the second or third molar.~16 individuals.~Manual Therapy (MT): Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week ."
11330115|NCT03454581|FG002|Participant Flow|Combined Therapy Group (CT)|"Applied the protocols of photobiomodulation group and immediately after, to MT group.~17 individuals."
11330116|NCT03454581|OG000|Outcome|Photobiomodulation Group|Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.
11330117|NCT03454581|OG001|Outcome|Manual Therapy Group (MT)|Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.
11330118|NCT03454581|OG002|Outcome|Combined Therapy Group (CT)|Applied the protocols of photobiomodulation group and immediately after, to MT group.
11330119|NCT03454581|OG002|Outcome|Combined Therapy Group (CT)|"Applied the protocols of photobiomodulation group and immediately after, to MT group.~."
11330120|NCT03454581|EG000|Reported Event|Photobiomodulation Group (PBM)|Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.
11330121|NCT03454581|EG001|Reported Event|Manual Therapy Group (MT)|Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.
11330122|NCT03454581|EG002|Reported Event|Combined Therapy Group (CT)|Applied the protocols of PBM group and immediately after, to MT group.
11330123|NCT03455218|BG000|Baseline|Nitric Oxide|"20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time~Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330124|NCT03455218|BG001|Baseline|Placebo|"INOmax device attached to the oxygenator, but no gas is delivered through the device~Placebo: INOmax device connected to oxygenator, but no gas is delivered~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330125|NCT03455218|BG002|Baseline|Total|Total of all reporting groups
11330126|NCT03455218|FG000|Participant Flow|Nitric Oxide|"20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time~Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330127|NCT03455218|FG001|Participant Flow|Placebo|"INOmax device attached to the oxygenator, but no gas is delivered through the device~Placebo: INOmax device connected to oxygenator, but no gas is delivered~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330128|NCT03455218|OG000|Outcome|Nitric Oxide|"20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time~Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330129|NCT03455218|OG001|Outcome|Placebo|"INOmax device attached to the oxygenator, but no gas is delivered through the device~Placebo: INOmax device connected to oxygenator, but no gas is delivered~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330130|NCT03455218|EG000|Reported Event|Nitric Oxide|"20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time~Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330131|NCT03455218|EG001|Reported Event|Placebo|"INOmax device attached to the oxygenator, but no gas is delivered through the device~Placebo: INOmax device connected to oxygenator, but no gas is delivered~INOmax: All patients will have the INOmax device connected to the oxygenator"
11330132|NCT03455491|BG000|Baseline|Group A|"XC221 100 mg orally.~1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period~XC221 100 mg: once daily during 3 days."
11330133|NCT03455491|BG001|Baseline|Group B|"XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period~XC221 200 mg: once daily during 3 days."
11330134|NCT03455491|BG002|Baseline|Group C|"Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period~Placebo: once daily during 3 days."
11330135|NCT03455491|BG003|Baseline|Total|Total of all reporting groups
11330136|NCT03455491|FG000|Participant Flow|Group A|"XC221 100 mg orally.~1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period~XC221 100 mg: once daily during 3 days."
11330137|NCT03455491|FG001|Participant Flow|Group B|"XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period~XC221 200 mg: once daily during 3 days."
11330138|NCT03455491|FG002|Participant Flow|Group C|"Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period~Placebo: once daily during 3 days."
11330139|NCT03455491|OG000|Outcome|XC221 100 mg|"XC221 100 mg orally.~1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period~XC221 100 mg: once daily during 3 days."
11330140|NCT03455491|OG001|Outcome|XC221 200 mg|"XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period~XC221 200 mg: once daily during 3 days."
11330141|NCT03455491|OG002|Outcome|Placebo|"Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period~Placebo: once daily during 3 days."
11330142|NCT03455491|EG000|Reported Event|Group A|"XC221 100 mg orally.~1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period~XC221 100 mg: once daily during 3 days."
11330143|NCT03455491|EG001|Reported Event|Group B|"XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period~XC221 200 mg: once daily during 3 days."
11330144|NCT03455491|EG002|Reported Event|Group C|"Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period~Placebo: once daily during 3 days."
11330145|NCT03455543|BG000|Baseline|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11330146|NCT03455543|BG001|Baseline|Sham Group|"Treatment with in-active (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System"
11330147|NCT03455543|BG002|Baseline|Total|Total of all reporting groups
11330148|NCT03455543|FG000|Participant Flow|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11330149|NCT03455543|FG001|Participant Flow|Sham Group|"Treatment with in-active (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System"
11330150|NCT03455543|FG002|Participant Flow|Open-label Extension Group (Part B)|Subjects receiving open-label active PEMF therapy in Part B after 17 weeks of randomized treatment in Part A.
11330151|NCT03455543|OG000|Outcome|Active Group|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11330152|NCT03455543|OG001|Outcome|Sham Group|"Treatment with in-active (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System"
11330153|NCT03455543|OG000|Outcome|Open-label Extension Group (Part B)|Subjects receiving open-label active PEMF therapy in Part B after 17 weeks of randomized treatment in Part A.
11330154|NCT03455543|EG000|Reported Event|Active Group (Part A)|"Treatment with active Provant Therapy System~Active Provant Therapy System: Treatment with active Provant Therapy System"
11330155|NCT03455543|EG001|Reported Event|Sham Group (Part A)|"Treatment with in-active (sham) Provant Therapy System~Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System"
11330156|NCT03455543|EG002|Reported Event|Open-label Extension Group (Part B)|Treatment with open-label active Provant Therapy System during Part B (months 4-12)
11330157|NCT03456245|BG000|Baseline|Vision Device Validation|"In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices.~Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging."
11330158|NCT03456245|FG000|Participant Flow|Vision Device Validation|"In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices.~Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging."
11330159|NCT03456245|OG000|Outcome|Vision Device Validation|"In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices.~Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging."
11330160|NCT03456245|EG000|Reported Event|Vision Device Validation|
11330161|NCT03456427|BG000|Baseline|All Study Participants|"All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.~Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.~Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site."
11330162|NCT03456427|FG000|Participant Flow|All Study Participants|"All subjects underwent standard of care imaging on one breast. The other breast was imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.~Patient-Assisted Compression (PAC): The technologist properly positioned the breast and applied minimum compression. The subject was instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image was acquired. This was done for both standard views CC & MLO.~Technologist-Controlled (TC) Compression: TC compression was conducted per standard of care practices at the site."
11330163|NCT03456427|OG000|Outcome|All Study Participants: Patient Assisted Compression|"All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.~Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO."
11330164|NCT03456427|OG001|Outcome|All Study Participants: Technologist Compression|"All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.~Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site."
11335755|NCT03555890|FG002|Participant Flow|Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11330165|NCT03456427|EG000|Reported Event|All Study Participants|"All subjects underwent standard of care imaging on one breast. The other breast was imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.~Patient-Assisted Compression (PAC): The technologist properly positioned the breast and applied minimum compression. The subject was instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image was acquired. This was done for both standard views CC & MLO.~Technologist-Controlled (TC) Compression: TC compression was conducted per standard of care practices at the site."
11330166|NCT03456856|BG000|Baseline|Ivabradine|The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.
11330167|NCT03456856|FG000|Participant Flow|Ivabradine|The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.
11330168|NCT03456856|OG000|Outcome|Ivabradine|The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.
11330169|NCT03456856|EG000|Reported Event|Ivabradine|The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.
11330170|NCT03456960|BG000|Baseline|Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin|TAK-438 10 milligram (mg) and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 2.
11330171|NCT03456960|BG001|Baseline|Pilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330172|NCT03456960|BG002|Baseline|Pivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 2.
11330173|NCT03456960|BG003|Baseline|Pivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330174|NCT03456960|BG004|Baseline|Study 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of Period 2.
11330175|NCT03456960|BG005|Baseline|Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330176|NCT03456960|BG006|Baseline|Total|Total of all reporting groups
11330177|NCT03456960|FG000|Participant Flow|Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin|TAK-438 10 milligram (mg) and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 2.
11330178|NCT03456960|FG001|Participant Flow|Pilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330179|NCT03456960|FG002|Participant Flow|Pivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 2.
11330180|NCT03456960|FG003|Participant Flow|Pivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330181|NCT03456960|FG004|Participant Flow|Study 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of Period 2.
11336276|NCT03565068|FG001|Participant Flow|Panel A (Healthy Participants): Placebo Monotherapy|Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
11330182|NCT03456960|FG005|Participant Flow|Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 14 days, further followed by TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of Period 2.
11330183|NCT03456960|OG000|Outcome|Pilot Study 1: TAK-438ASA|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330184|NCT03456960|OG001|Outcome|Pilot Study 1: TAK-438 and Aspirin|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330185|NCT03456960|OG002|Outcome|Pivotal Study 1: TAK-438ASA|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330186|NCT03456960|OG003|Outcome|Pivotal Study 1: TAK-438 and Aspirin|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330187|NCT03456960|OG000|Outcome|Study 2: TAK-438ASA Fasted|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330188|NCT03456960|OG001|Outcome|Study 2: TAK-430ASA Fed|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of either Period 1 or 2.
11330189|NCT03456960|OG001|Outcome|Study 2: TAK-438ASA Fed|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of either Period 1 or 2.
11330190|NCT03456960|OG001|Outcome|Study 2: TAK-438ASA Fed|TAK-438 10 mg and Aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of either Period 1 or 2.
11330191|NCT03456960|EG000|Reported Event|Pilot Study 1: TAK-438ASA|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330192|NCT03456960|EG001|Reported Event|Pilot Study 1: TAK-438 and Aspirin|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330193|NCT03456960|EG002|Reported Event|Pivotal Study 1: TAK-438ASA|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330194|NCT03456960|EG003|Reported Event|Pivotal Study 1: TAK-438 and Aspirin|TAK-438 10 mg, tablet and aspirin 100 mg, tablet (free combination), orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330195|NCT03456960|EG004|Reported Event|Study 2: TAK-438ASA Fasted|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fasted condition, once on Day 1 of either Period 1 or 2.
11330196|NCT03456960|EG005|Reported Event|Study 2: TAK-438ASA Fed|TAK-438 10 mg and aspirin 100 mg FDC (TAK-438ASA), tablet, orally, under fed condition, once on Day 1 of either Period 1 or 2.
11330197|NCT03457103|BG000|Baseline|CATCH Group|"A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention~Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330198|NCT03457103|BG001|Baseline|Control Group|"Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330199|NCT03457103|BG002|Baseline|Total|Total of all reporting groups
11330200|NCT03457103|FG000|Participant Flow|CATCH Group|"A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention~Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330201|NCT03457103|FG001|Participant Flow|Control Group|"Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330202|NCT03457103|OG000|Outcome|CATCH Group|"A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention~Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330203|NCT03457103|OG001|Outcome|Control Group|"Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330204|NCT03457103|EG000|Reported Event|CATCH Group|"A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention~Capnometry-Assisted Training for COPD to Slow the Breath (CATCH): Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330205|NCT03457103|EG001|Reported Event|Control Group|"Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.~Pulmonary Rehabilitation (PR): Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration)."
11330206|NCT03457116|BG000|Baseline|NSAIDS|"400mg of Ibuprofen~NSAID: Ibuprofen 400mg for post-operative pain"
11330207|NCT03457116|BG001|Baseline|Opiates|"Norco (hydrocodone 5mg- acetaminophen 325mg)~Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)"
11330208|NCT03457116|BG002|Baseline|Total|Total of all reporting groups
11330209|NCT03457116|FG000|Participant Flow|NSAIDS|"400mg of Ibuprofen~NSAID: Ibuprofen 400mg for post-operative pain"
11330210|NCT03457116|FG001|Participant Flow|Opiates|"Norco (hydrocodone 5mg- acetaminophen 325mg)~Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)"
11330211|NCT03457116|OG000|Outcome|NSAIDS|"400mg of Ibuprofen~NSAID: Ibuprofen 400mg for post-operative pain"
11330212|NCT03457116|OG001|Outcome|Opiates|"Norco (hydrocodone 5mg- acetaminophen 325mg)~Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)"
11330213|NCT03457116|EG000|Reported Event|NSAIDS|"400mg of Ibuprofen~NSAID: Ibuprofen 400mg for post-operative pain"
11330214|NCT03457116|EG001|Reported Event|Opiates|"Norco (hydrocodone 5mg- acetaminophen 325mg)~Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)"
11330215|NCT03457636|BG000|Baseline|Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide|"All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks~Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals~Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes"
11330216|NCT03457636|FG000|Participant Flow|Doxycycline Anhydrous 40 mg Once Daily and Adapalene/Benzoyl p|"All subjects will receive at Baseline doxycycline anhydrous 40 mg and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily~Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals~Adapalene-Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes"
11330217|NCT03457636|OG000|Outcome|Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide|"All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks~Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals~Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes"
11330218|NCT03457636|EG000|Reported Event|Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide|"All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks~Doxycycline Anhydrous 40 MG: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals~Adapalene/Benzoyl Peroxide Gel 0.3-2.5%: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes"
11330219|NCT03457727|BG000|Baseline|DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State|Participants received a sequence of the following: single oral dose of 50 milligrams (mg) DNX hydrobromide (HBr) hemihydrate tablet formulation (600 mg tablet manufactured by RC [600 RC]) on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (475 mg tablet manufactured by DC [475 DC]) on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (600 DC) on Day 1 of treatment period 3 and 50 mg DNX HBr hemihydrate 600 DC tablet formulation with containing 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fed state (with a high fat meal). The treatment periods were separated by a washout period of 5 days.
11330220|NCT03457727|BG001|Baseline|DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 600 RC on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC on Day 1 of treatment period 2, a single oral dose 50 mg DNX HBr hemihydrate 600 DC on Day 1 of treatment period 3 and a single oral dose of 50 mg DNX HBr hemihydrate 600 DC with 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fasted state. The treatment periods were separated by a washout period of 5 days.
11330221|NCT03457727|BG002|Baseline|DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC tablet formulation in fasted state on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with normal meal on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with high fat meal in treatment period 3, followed by a single oral dose of 50 mg DNX HBr monohydrate 475 DC with high fat meal in treatment period 4. The treatment periods were separated by a washout period of 5 days.
11330222|NCT03457727|BG003|Baseline|DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC in fasted state along with 40 mg omeprazole (OMP) during treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with normal meal in treatment period 2 and a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with high fat meal in treatment period 3. The treatment periods were separated by a washout period of 5 days. OMP was administered from Day -4 of each treatment period through washout periods.
11330223|NCT03457727|BG004|Baseline|Total|Total of all reporting groups
11330224|NCT03457727|FG000|Participant Flow|DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State|Participants received a sequence of the following: single oral dose of 50 milligrams (mg) DNX hydrobromide (HBr) hemihydrate tablet formulation (600 mg tablet manufactured by RC [600 RC]) on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (475 mg tablet manufactured by DC [475 DC]) on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (600 DC) on Day 1 of treatment period 3 and 50 mg DNX HBr hemihydrate 600 DC tablet formulation with containing 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fed state (with a high fat meal). The treatment periods were separated by a washout period of 5 days.
11330225|NCT03457727|FG001|Participant Flow|DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 600 RC on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC on Day 1 of treatment period 2, a single oral dose 50 mg DNX HBr hemihydrate 600 DC on Day 1 of treatment period 3 and a single oral dose of 50 mg DNX HBr hemihydrate 600 DC with 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fasted state. The treatment periods were separated by a washout period of 5 days.
11330226|NCT03457727|FG002|Participant Flow|DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC tablet formulation in fasted state on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with normal meal on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with high fat meal in treatment period 3, followed by a single oral dose of 50 mg DNX HBr monohydrate 475 DC with high fat meal in treatment period 4. The treatment periods were separated by a washout period of 5 days.
11330227|NCT03457727|FG003|Participant Flow|DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State|Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC in fasted state along with 40 mg omeprazole (OMP) during treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with normal meal in treatment period 2 and a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with high fat meal in treatment period 3. The treatment periods were separated by a washout period of 5 days. OMP was administered from Day -4 of each treatment period through washout periods.
11330228|NCT03457727|OG000|Outcome|600RC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
11330229|NCT03457727|OG001|Outcome|475DC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
11330230|NCT03457727|OG002|Outcome|600DC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
11330231|NCT03457727|OG003|Outcome|600DC 5%HPMC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
11330232|NCT03457727|OG004|Outcome|600RC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
11330233|NCT03457727|OG005|Outcome|475DC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
11330234|NCT03457727|OG006|Outcome|600DC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
11330235|NCT03457727|OG007|Outcome|600DC 5%HPMC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
11330236|NCT03457727|OG000|Outcome|475DC-Fasted|Participants received a single dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation in fasted state
11330237|NCT03457727|OG001|Outcome|475DC-Normal Meal|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with normal meal
11330238|NCT03457727|OG002|Outcome|475DC-High Fat|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with high fat meal
11330239|NCT03457727|OG003|Outcome|475DC-MONO High Fat|Participants received DNX 50 mg HBr monohydrate 475 DC with 5 percent HPMC formulation along with high fat meal
11330240|NCT03457727|OG004|Outcome|475DC Fasted OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP under fasted condition
11330241|NCT03457727|OG005|Outcome|475DC Normal Meal OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with normal meal
11330242|NCT03457727|OG006|Outcome|475DC High Fat OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with high fat meal
11330243|NCT03457727|EG000|Reported Event|600RC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
11330244|NCT03457727|EG001|Reported Event|475DC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
11330245|NCT03457727|EG002|Reported Event|600DC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
11330246|NCT03457727|EG003|Reported Event|600DC 5%HPMC High Fat|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
11330247|NCT03457727|EG004|Reported Event|600RC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
11330248|NCT03457727|EG005|Reported Event|475DC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
11330249|NCT03457727|EG006|Reported Event|600DC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
11330250|NCT03457727|EG007|Reported Event|600DC 5%HPMC Fasted|Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
11330251|NCT03457727|EG008|Reported Event|475DC-Fasted|Participants received a single dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation in fasted state
11330252|NCT03457727|EG009|Reported Event|475DC-Normal Meal|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with normal meal
11330253|NCT03457727|EG010|Reported Event|475DC-High Fat|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with high fat meal
11330254|NCT03457727|EG011|Reported Event|475DC-MONO High Fat|Participants received DNX 50 mg HBr monohydrate 475 DC with 5 percent HPMC formulation along with high fat meal
11330255|NCT03457727|EG012|Reported Event|475DC-Fasted OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP under fasted condition
11330256|NCT03457727|EG013|Reported Event|475DC-Normal Meal OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with normal meal
11330257|NCT03457727|EG014|Reported Event|475DC-High Fat OMP|Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with high fat meal
11330258|NCT03457909|BG000|Baseline|DS-MCE|"outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.~DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely."
11330259|NCT03457909|FG000|Participant Flow|DS-MCE|"outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination.~DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely."
11330260|NCT03457909|OG000|Outcome|DS-MCE|"outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination.~DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely."
11330261|NCT03457909|EG000|Reported Event|DS-MCE|"outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination.~DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely."
11330262|NCT03458702|BG000|Baseline|YogaFit and Quit Rest|"Participants completed 30 min of YogaFit and then 30 min of Quiet Rest on different days.~YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body."
11330263|NCT03458702|FG000|Participant Flow|YogaFit Then Quit Rest|"Participants completed a 30 min YogaFit Session and then a 30 min Quiet Rest Session on different days.~YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.~On another day, participants completed 30 min of Quiet Rest"
11330264|NCT03458702|FG001|Participant Flow|Quiet Rest Then Yoga Fit|Participants completed 30 min of Quiet Rest and then 30 min of YogaFit on different days.
11330265|NCT03458702|OG000|Outcome|YogaFit|YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
11330266|NCT03458702|OG001|Outcome|Quiet Rest|30 min of Quiet Rest
11330267|NCT03458702|EG000|Reported Event|YogaFit|"Participants completed a 30 min YogaFit Session.~YogaFit: For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.~On another day, participants completed 30 min of Quiet Rest"
11330268|NCT03458702|EG001|Reported Event|Quiet Rest|Participants completed 30 min of Quiet Rest.
11335756|NCT03555890|FG003|Participant Flow|Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
11335757|NCT03555890|OG000|Outcome|Part 1: Levocetirizine ODT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11330269|NCT03458871|BG000|Baseline|4-week TTNS Home Based Protocol|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.~4-week TTNS home-based protocol: 4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.~In addition, if the patient perceives pain, the intensity will be lowered until comfortable.~Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used."
11330270|NCT03458871|FG000|Participant Flow|4-week TTNS Home Based Protocol|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.~4-week TTNS home-based protocol: 4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.~In addition, if the patient perceives pain, the intensity will be lowered until comfortable.~Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used."
11330271|NCT03458871|OG000|Outcome|4-week TTNS Home Based Protocol|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.~4-week TTNS home-based protocol: 4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.~In addition, if the patient perceives pain, the intensity will be lowered until comfortable.~Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used."
11330272|NCT03458871|EG000|Reported Event|4-week TTNS Home Based Protocol|"Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.~4-week TTNS home-based protocol: 4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.~In addition, if the patient perceives pain, the intensity will be lowered until comfortable.~Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used."
11330273|NCT03459040|BG000|Baseline|Alpha-1-antitrypsin (AAT)|AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks).
11330274|NCT03459040|FG000|Participant Flow|Alpha-1-antitrypsin (AAT)|AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks).
11330275|NCT03459040|OG000|Outcome|Alpha-1-antitrypsin (AAT)|AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks).
11330276|NCT03459040|OG000|Outcome|Number of Participants Requiring Steroid Treatment|"Number of participants with chronic GVHD requiring systemic steroid treatment~alpha-1-antitrypsin (AAT) AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks)."
11330277|NCT03459040|EG000|Reported Event|Alpha-1-antitrypsin (AAT)|AAT was administered intravenously at a loading dose of 90 mg/kg (study day 0), followed by twice weekly doses of 45 mg/kg for 15 more doses (totaling 16 doses over 8 weeks).
11330278|NCT03459131|BG000|Baseline|Overall|Comfilcon A with Digital Zone Optics™ contact lenses and comfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
11330279|NCT03459131|FG000|Participant Flow|BIOFINITY ENERGYS Then BIOFINITY|Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
11330280|NCT03459131|FG001|Participant Flow|BIOFINITY Then BIOFINITY ENERGYS|Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
11330281|NCT03459131|OG000|Outcome|BIOFINITY ENERGYS|Comfilcon A with Digital Zone Optics™ contact lenses worn during Period 1 or Period 2 for 7 days.
11330282|NCT03459131|OG001|Outcome|BIOFINITY|Comfilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
11330283|NCT03459131|EG000|Reported Event|BIOFINITY ENERGYS|All subjects exposed to comfilcon A with Digital Zone Optics™ contact lenses
11330284|NCT03459131|EG001|Reported Event|BIOFINITY|All subject exposed to comfilcon A contact lenses
11330285|NCT03459196|BG000|Baseline|THERMOCOOL SMARTTOUCH SF-5D Catheter|A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
11330286|NCT03459196|FG000|Participant Flow|THERMOCOOL SMARTTOUCH SF-5D Catheter|A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
11330287|NCT03459196|OG000|Outcome|THERMOCOOL SMARTTOUCH SF-5D Catheter|A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
11330288|NCT03459196|EG000|Reported Event|THERMOCOOL SMARTTOUCH SF-5D Catheter|A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode.
11330289|NCT03459612|BG000|Baseline|Sequence 1|"Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.~Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330290|NCT03459612|BG001|Baseline|Sequence 2|"Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.~Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330291|NCT03459612|BG002|Baseline|Sequence 3|"Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.~Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330292|NCT03459612|BG003|Baseline|Sequence 4|"Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.~Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330293|NCT03459612|BG004|Baseline|Total|Total of all reporting groups
11330294|NCT03459612|FG000|Participant Flow|Sequence 1|"Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330295|NCT03459612|FG001|Participant Flow|Sequence 2|Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration
11330296|NCT03459612|FG002|Participant Flow|Sequence 3|"Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330297|NCT03459612|FG003|Participant Flow|Sequence 4|"Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.~Each period is 3 days duration"
11330298|NCT03459612|OG000|Outcome|Placebo|Placebo administered orally in one of four study periods.
11330299|NCT03459612|OG001|Outcome|100 mg Lasmiditan|100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
11330300|NCT03459612|OG002|Outcome|200 mg Lasmiditan|200 mg Lasmiditan administered PO in one of four study periods.
11330301|NCT03459612|OG003|Outcome|50 mg Diphenhydramine|Diphenhydramine administered PO in one of four study periods.
11330302|NCT03459612|OG000|Outcome|Placebo|Placebo administered orally (PO) in one of four study periods.
11330303|NCT03459612|OG000|Outcome|100 mg Lasmiditan|100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
11330304|NCT03459612|OG001|Outcome|200 mg Lasmiditan|200 mg Lasmiditan administered PO in one of four study periods.
11330305|NCT03459612|EG000|Reported Event|Placebo|Placebo administered orally in one of four study periods.
11330306|NCT03459612|EG001|Reported Event|100 mg Lasmiditan|100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
11330307|NCT03459612|EG002|Reported Event|200 mg Lasmiditan|200 mg Lasmiditan administered PO in one of four study periods.
11330308|NCT03459612|EG003|Reported Event|50 mg Diphenhydramine|Diphenhydramine administered PO in one of four study periods.
11333833|NCT03520387|OG001|Outcome|Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11333834|NCT03520387|OG002|Outcome|Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11335758|NCT03555890|OG001|Outcome|Part 1: Levocetirizine IRT 5 mg|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11330309|NCT03459794|BG000|Baseline|Ivermectin|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth."
11330310|NCT03459794|BG001|Baseline|Control|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once"
11330311|NCT03459794|BG002|Baseline|Total|Total of all reporting groups
11330312|NCT03459794|FG000|Participant Flow|Ivermectin|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth."
11330313|NCT03459794|FG001|Participant Flow|Control|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once"
11330314|NCT03459794|OG000|Outcome|Ivermectin 4hrs|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment"
11330315|NCT03459794|OG001|Outcome|Ivermectin 24 Hrs|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment"
11330316|NCT03459794|OG002|Outcome|Control 4 Hrs|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment"
11330317|NCT03459794|OG003|Outcome|Control 24 Hrs|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment"
11330318|NCT03459794|OG000|Outcome|Ivermectin 0 Hrs|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth. Blood collected at t=0"
11330319|NCT03459794|OG001|Outcome|Ivermectin 24 Hrs|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth.Blood collected 24 hrs post-treatment"
11330320|NCT03459794|OG002|Outcome|Control 0 Hrs|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once. Blood collected at t=0"
11330321|NCT03459794|OG003|Outcome|Control 24 Hrs|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once. Blood collected 24hrs post-treatment"
11330322|NCT03459794|EG000|Reported Event|Ivermectin|"Ivermectin will be administered once at 150mcg/kg, orally.~Ivermectin: 150 mcg/kg ivermectin, by mouth."
11330323|NCT03459794|EG001|Reported Event|Control|"An oral placebo will be administered once~Placebo: An oral placebo will be administered, once"
11330324|NCT03460587|BG000|Baseline|Home-based Telerehabilitation|"Home-based Telerehabilitation~Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed."
11330325|NCT03460587|FG000|Participant Flow|Home-based Telerehabilitation|"Home-based Telerehabilitation~Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed."
11330326|NCT03460587|OG000|Outcome|Home-based Telerehabilitation|"Home-based Telerehabilitation~Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed."
11330327|NCT03460587|EG000|Reported Event|Home-based Telerehabilitation|"Home-based Telerehabilitation~Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed."
11330328|NCT03460652|BG000|Baseline|Active Treatment|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11330329|NCT03460652|FG000|Participant Flow|Active Treatment|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11330330|NCT03460652|OG000|Outcome|Treatment-Phase Safety Population|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11330331|NCT03460652|OG000|Outcome|Open-Label KP415|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11330332|NCT03460652|EG000|Reported Event|Active Treatment|"Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule:~28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl)"
11335759|NCT03555890|OG000|Outcome|Part 2: Levocetirizine ODT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11335760|NCT03555890|OG001|Outcome|Part 2: Levocetirizine IRT 5 mg|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11330333|NCT03460899|BG000|Baseline|Clamp Arm|"All 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insuline (Actrapid) will be used to reach certain plasma glucose levels.~Euglycaemic Clamp: All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)~Hyperinsulinaemic/Hypoglycaemic Clamp: All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)"
11330334|NCT03460899|FG000|Participant Flow|Clamp Arm|"All 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insuline (Actrapid) will be used to reach certain plasma glucose levels.~Euglycaemic Clamp: All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)~Hyperinsulinaemic/Hypoglycaemic Clamp: All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)"
11330335|NCT03460899|OG000|Outcome|Clamp Arm|"All 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insuline (Actrapid) will be used to reach certain plasma glucose levels.~Euglycaemic Clamp: All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)~Hyperinsulinaemic/Hypoglycaemic Clamp: All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)"
11330336|NCT03460899|EG000|Reported Event|Clamp Arm|"All 14 subjects will undergo an Euglycaemic Clamp at Visit 2 as well as a Hyperinsulinaemic/Hypoglycaemic Clamp at Visit 3 with the Intervention of reaching certain plasma glucose levels for blood sampling regarding platelet activity parameters. Infusion of Dextrose and human soluble insuline (Actrapid) will be used to reach certain plasma glucose levels.~Euglycaemic Clamp: All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)~Hyperinsulinaemic/Hypoglycaemic Clamp: All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)"
11330337|NCT03460990|BG000|Baseline|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330338|NCT03460990|BG001|Baseline|VX-659/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330339|NCT03460990|BG002|Baseline|Total|Total of all reporting groups
11330340|NCT03460990|FG000|Participant Flow|TEZ/IVA|Following a run-in period of 4 weeks with Tezacaftor (TEZ)/Ivacaftor (IVA), participants received TEZ 100 milligram (mg)/IVA 150 mg as fixed-dose combination (FDC) tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the triple combination (TC) treatment period.
11330341|NCT03460990|FG001|Participant Flow|VX-659/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330342|NCT03460990|OG000|Outcome|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330343|NCT03460990|OG001|Outcome|VX-659/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330344|NCT03460990|EG000|Reported Event|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330345|NCT03460990|EG001|Reported Event|VX-659/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11330346|NCT03461146|BG000|Baseline|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11330347|NCT03461146|FG000|Participant Flow|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11330348|NCT03461146|OG000|Outcome|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11330349|NCT03461146|EG000|Reported Event|MT-6548|MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
11330350|NCT03461757|BG000|Baseline|Rimegepant 75 mg ODT|Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330351|NCT03461757|BG001|Baseline|Placebo|Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330352|NCT03461757|BG002|Baseline|Total|Total of all reporting groups
11330353|NCT03461757|FG000|Participant Flow|Rimegepant 75 mg ODT|Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330354|NCT03461757|FG001|Participant Flow|Placebo|Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330355|NCT03461757|OG000|Outcome|Rimegepant 75 mg ODT|Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330356|NCT03461757|OG001|Outcome|Placebo|Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330357|NCT03461757|EG000|Reported Event|Rimegepant 75 mg ODT|Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330358|NCT03461757|EG001|Reported Event|Placebo|Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
11330359|NCT03461965|BG000|Baseline|Education With 3D Printed Model|"The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model~3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery~Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330360|NCT03461965|BG001|Baseline|Verbal Counselling|"Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330361|NCT03461965|BG002|Baseline|Total|Total of all reporting groups
11330362|NCT03461965|FG000|Participant Flow|Education With 3D Printed Model|"The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model~3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330363|NCT03461965|FG001|Participant Flow|Verbal Counselling|"Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330364|NCT03461965|OG000|Outcome|Education With 3D Printed Model|"The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model~3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330365|NCT03461965|OG001|Outcome|Verbal Counselling|"Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script~Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330366|NCT03461965|EG000|Reported Event|Education With 3D Printed Model|"The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model~3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery~Verbal Counselling: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330367|NCT03461965|EG001|Reported Event|Verbal Counselling|"Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script~Verbal Counselling: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery"
11330368|NCT03462082|BG000|Baseline|All Study Participants|All Study Participants
11330369|NCT03462082|FG000|Participant Flow|Bilateral DBS Then Asymmetric DBS 1 Then Asymmetric DBS 2|Baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks.
11330370|NCT03462082|FG001|Participant Flow|Bilateral DBS Then Asymmetric DBS 2 Then Asymmetric DBS 1|Baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks.
11330371|NCT03462082|FG002|Participant Flow|Asymmetric DBS 1 Then Bilateral DBS Then Asymmetric DBS 2|Asymmetric STN-DBS 1 (right STN amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks.
11330372|NCT03462082|FG003|Participant Flow|Asymmetric DBS 1 Then Asymmetric DBS 2 Then Bilateral DBS|Asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks.
11330373|NCT03462082|FG004|Participant Flow|Asymmetric DBS 2 Then Bilateral DBS Then Asymmetric DBS 1|Asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks.
11330374|NCT03462082|FG005|Participant Flow|Asymmetric DBS 2 Then Asymmetric DBS 1 Then Bilateral DBS|Asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks.
11335761|NCT03555890|EG000|Reported Event|Part 1: Levocetirizine ODT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11330375|NCT03462082|FG006|Participant Flow|Asymmetric DBS 1 (Open Label)|"After the Study Phase (Randomized, Blinded Period) was completed, patients were offered to participate in an Open Label Phase in which they would be switched for at least 12 weeks to either the Asymmetric DBS 1 or the Asymmetric DBS 2 condition if it was associated with axial symptom improvement when compared to their baseline bilateral DBS condition.~Out of the 22 patients initially enrolled, 17 opted to participate. Out of the 17 patients that opted to participate, 7 were switched to the Asymmetric DBS 1 condition: 50% reduction of right STN-DBS amplitude (voltage)"
11330376|NCT03462082|FG007|Participant Flow|Asymmetric DBS 2 (Open Label)|"After the Study Phase (Randomized, Blinded Period) was completed, patients were offered to participate in an Open Label Phase in which they would be switched for at least 12 weeks to either the Asymmetric DBS 1 or the Asymmetric DBS 2 condition if it was associated with axial symptom improvement when compared to their baseline bilateral DBS condition.~Out of the 22 patients initially enrolled, 17 opted to participate. Out of the 17 patients that opted to participate, 10 were switched to the Asymmetric DBS 2 condition: 50% reduction of left STN-DBS amplitude (voltage)"
11330377|NCT03462082|OG000|Outcome|Bilateral STN-DBS|Bilateral (baseline) STN-DBS settings
11330378|NCT03462082|OG001|Outcome|Asymmetric STN-DBS 1|50% reduction of right STN-DBS amplitude (voltage)
11330379|NCT03462082|OG002|Outcome|Asymmetric STN-DBS 2|50% reduction of left STN-DBS amplitude (voltage)
11330380|NCT03462082|EG000|Reported Event|Bilateral STN-DBS (Study Phase)|Bilateral (baseline) STN-DBS settings (During the randomized, blinded phase)
11330381|NCT03462082|EG001|Reported Event|Asymmetric STN-DBS 1 (Study Phase)|50% reduction of right STN-DBS amplitude (voltage) (During the randomized, blinded phase)
11330382|NCT03462082|EG002|Reported Event|Asymmetric STN-DBS 2 (Study Phase)|50% reduction of left STN-DBS amplitude (voltage) (During the randomized, blinded phase)
11330383|NCT03462082|EG003|Reported Event|Asymmetric STN-DBS 1 (Open Label Phase)|50% reduction of right STN-DBS amplitude (voltage) (During the open label phase)
11330384|NCT03462082|EG004|Reported Event|Asymmetric STN-DBS 2 (Open Label Phase)|50% reduction of left STN-DBS amplitude (voltage) (During the open label phase)
11330385|NCT03462576|BG000|Baseline|Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm|Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
11330386|NCT03462576|BG001|Baseline|Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm|Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
11330387|NCT03462576|BG002|Baseline|Number of Subjects Experiencing a High Risk Event in Placebo Arm|Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm .
11330388|NCT03462576|BG003|Baseline|Total|Total of all reporting groups
11330389|NCT03462576|FG000|Participant Flow|Patients With Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm|Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
11330390|NCT03462576|FG001|Participant Flow|Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm|Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
11330391|NCT03462576|FG002|Participant Flow|Number of Subjects Experiencing a High Risk Event in Placebo Arm|Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm .
11330392|NCT03462576|OG000|Outcome|Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm|Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
11330393|NCT03462576|OG001|Outcome|Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm|Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
11330394|NCT03462576|OG002|Outcome|Number of Subjects Experiencing a High Risk Event in Placebo Arm|Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm.
11330395|NCT03462576|EG000|Reported Event|Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm|Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
11330396|NCT03462576|EG001|Reported Event|Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm|Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
11330397|NCT03462576|EG002|Reported Event|Number of Subjects Experiencing a High Risk Event in Placebo Arm|Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm.
11330398|NCT03462680|BG000|Baseline|Niacin|"Niacin 250 mg is compared to placebo tablet.~niacin: Niacin or nicotinic acid 250 mg tablets"
11330399|NCT03462680|BG001|Baseline|Placebo|"placebo~placebo: placebo tablet"
11330400|NCT03462680|BG002|Baseline|Total|Total of all reporting groups
11330401|NCT03462680|FG000|Participant Flow|Niacin|"Niacin 250 mg is compared to placebo tablet.~niacin: Niacin or nicotinic acid 250 mg tablets"
11330402|NCT03462680|FG001|Participant Flow|Placebo|"placebo~placebo: placebo tablet"
11330403|NCT03462680|OG000|Outcome|Niacin|"Niacin 250 mg is compared to placebo tablet.~niacin: Niacin or nicotinic acid 250 mg tablets"
11330404|NCT03462680|OG001|Outcome|Placebo|"placebo~placebo: placebo tablet"
11330405|NCT03462680|EG000|Reported Event|Niacin|"Niacin 250 mg is compared to placebo tablet.~niacin: Niacin or nicotinic acid 250 mg tablets"
11330406|NCT03462680|EG001|Reported Event|Placebo|"placebo~placebo: placebo tablet"
11330407|NCT03462745|BG000|Baseline|Cannulation With AccuVein AV 300|"The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.~AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation"
11330408|NCT03462745|BG001|Baseline|Standard Insertion|Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
11330409|NCT03462745|BG002|Baseline|Total|Total of all reporting groups
11330410|NCT03462745|FG000|Participant Flow|Cannulation With AccuVein AV 300|"The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.~AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation"
11330411|NCT03462745|FG001|Participant Flow|Standard Insertion|Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
11330412|NCT03462745|OG000|Outcome|Cannulation With AccuVein AV 300|"The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.~AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation"
11330413|NCT03462745|OG001|Outcome|Standard Insertion|Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
11330414|NCT03462745|EG000|Reported Event|Cannulation With AccuVein AV 300|"The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.~AccuVein AV 300: Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation~No adverse events reported."
11330415|NCT03462745|EG001|Reported Event|Standard Insertion|"Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.~No adverse events reported."
11330416|NCT03462927|BG000|Baseline|MC2-01 Cream|"MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).~MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)"
11330417|NCT03462927|BG001|Baseline|CAL/BDP Combination|"CAL/BDP ointment (w/w 0.005%/0.064%).~CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)"
11330418|NCT03462927|BG002|Baseline|Total|Total of all reporting groups
11330419|NCT03462927|FG000|Participant Flow|MC2-01 Cream|"MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%). One application daily for 8 weeks.~MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)"
11330420|NCT03462927|FG001|Participant Flow|CAL/BDP Combination|"CAL/BDP ointment (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%, w/w 0.005%/0.064%). One daily application for 4 weeks.~CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)"
11330421|NCT03462927|OG000|Outcome|MC2-01 Cream|MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
11330422|NCT03462927|OG001|Outcome|CAL/BDP Ointment|CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
11330423|NCT03462927|OG000|Outcome|MC2-01 Cream|MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
11330424|NCT03462927|OG001|Outcome|CAL/BDP Combination|CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
11330425|NCT03462927|EG000|Reported Event|MC2-01 Cream|"MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).~MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)"
11330426|NCT03462927|EG001|Reported Event|CAL/BDP Combination|"CAL/BDP ointment (w/w 0.005%/0.064%).~CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)"
11330427|NCT03463031|BG000|Baseline|GSP 301 NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330428|NCT03463031|BG001|Baseline|Placebo NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330429|NCT03463031|BG002|Baseline|Total|Total of all reporting groups
11330430|NCT03463031|FG000|Participant Flow|GSP 301 NS|"Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS.~Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days"
11330431|NCT03463031|FG001|Participant Flow|Placebo NS|GSP 301 Placebo NS. Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330432|NCT03463031|OG000|Outcome|GSP 301 NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330433|NCT03463031|OG001|Outcome|Placebo NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330434|NCT03463031|EG000|Reported Event|GSP 301 NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330435|NCT03463031|EG001|Reported Event|Placebo NS|Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
11330436|NCT03463161|BG000|Baseline|Acquired Resistance or Suboptimal Benefit Group|Participants that have or have not benefited from prior treatment with immunotherapy.
11330437|NCT03463161|FG000|Participant Flow|Acquired Resistance or Suboptimal Benefit Group|Participants that have or have not benefited from prior treatment with immunotherapy.
11330438|NCT03463161|OG000|Outcome|Acquired Resistance or Suboptimal Benefit Group|Participants that have or have not benefited from prior treatment with immunotherapy.
11330439|NCT03463161|EG000|Reported Event|Acquired Resistance or Suboptimal Benefit Group|Participants that have or have not benefited from prior treatment with immunotherapy.
11330440|NCT03463512|BG000|Baseline|Racecadotril Plus Standard Treatment Oral Rehydration Solution|Racecadotril plus ORS: Racecadotril plus ORS
11330441|NCT03463512|BG001|Baseline|ORS (Standard Treatment)|ORS: ORS
11330442|NCT03463512|BG002|Baseline|Total|Total of all reporting groups
11330443|NCT03463512|FG000|Participant Flow|Racecadotril Plus Standard Treatment Oral Rehydration Solution|Racecadotril plus ORS: Racecadotril plus ORS
11330444|NCT03463512|FG001|Participant Flow|ORS (Standard Treatment)|ORS: ORS
11330445|NCT03463512|OG000|Outcome|Racecadotril Plus Standard Treatment Oral Rehydration Solution|Racecadotril plus ORS: Racecadotril plus ORS
11330446|NCT03463512|OG001|Outcome|ORS (Standard Treatment)|ORS: ORS
11330447|NCT03463512|EG000|Reported Event|Racecadotril Plus Standard Treatment Oral Rehydration Solution|Racecadotril plus ORS: Racecadotril plus ORS
11330448|NCT03463512|EG001|Reported Event|ORS (Standard Treatment)|ORS: ORS
11330449|NCT03463889|BG000|Baseline|Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)|"Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.~Gallium Ga 68-labeled PSMA-11: Given IV~Magnetic Resonance Imaging: Undergo MRI in combination with PET~Positron Emission Tomography (PET): Undergo PET in combination with MRI"
11330450|NCT03463889|FG000|Participant Flow|Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)|"Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.~Gallium Ga 68-labeled PSMA-11: Given IV~Magnetic Resonance Imaging: Undergo MRI in combination with PET~Positron Emission Tomography (PET): Undergo PET in combination with MRI"
11330451|NCT03463889|OG000|Outcome|Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)|"Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.~Gallium Ga 68-labeled PSMA-11: Given IV~Magnetic Resonance Imaging: Undergo MRI in combination with PET~Positron Emission Tomography (PET): Undergo PET in combination with MRI"
11330452|NCT03463889|EG000|Reported Event|Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)|"Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.~Gallium Ga 68-labeled PSMA-11: Given IV~Magnetic Resonance Imaging: Undergo MRI in combination with PET~Positron Emission Tomography (PET): Undergo PET in combination with MRI"
11330453|NCT03463915|BG000|Baseline|Bladder Instillation WITH Triamcinolone Acetonide|Six weekly bladder instillations WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg/1 mL).
11330454|NCT03463915|BG001|Baseline|Bladder Instillation WITHOUT Triamcinolone Acetonide|Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
11330455|NCT03463915|BG002|Baseline|Total|Total of all reporting groups
11330456|NCT03463915|FG000|Participant Flow|Bladder Instillation WITH Triamcinolone Acetonide|Six weekly bladder instillations WITH triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg)/1 mL.
11330457|NCT03463915|FG001|Participant Flow|Bladder Instillation WITHOUT Triamcinolone Acetonide|Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
11330458|NCT03463915|OG000|Outcome|Bladder Instillation WITH Triamcinolone Acetonide|"Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).~Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL)."
11330459|NCT03463915|OG001|Outcome|Bladder Instillation WITHOUT Triamcinolone Acetonide|"Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).~Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL)."
11330460|NCT03463915|OG000|Outcome|Bladder Instillation WITH Triamcinolone Acetonide|Six weekly bladder instillations WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg/1 mL).
11330461|NCT03463915|OG001|Outcome|Bladder Instillation WITHOUT Triamcinolone Acetonide|Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
11330462|NCT03463915|EG000|Reported Event|Bladder Instillation WITH Triamcinolone Acetonide|"Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).~Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL)."
11330463|NCT03463915|EG001|Reported Event|Bladder Instillation WITHOUT Triamcinolone Acetonide|"Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).~Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL)."
11335762|NCT03555890|EG001|Reported Event|Part 1: Levocetirizine IRT 5 mg|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11335763|NCT03555890|EG002|Reported Event|Part 2: Levocetirizine ODT 5 mg|All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11335764|NCT03555890|EG003|Reported Event|Part 2: Levocetirizine IRT 5 mg|All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
11330464|NCT03463941|BG000|Baseline|African American Church Members|"Peer Support Dyad Intervention: Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed."
11330465|NCT03463941|FG000|Participant Flow|African American Church Members|"Peer Support Dyad Intervention: Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed."
11330466|NCT03463941|OG000|Outcome|African American Church Members|"Peer Support Dyad Intervention: Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed."
11330467|NCT03463941|OG000|Outcome|Health Educators|North Carolina Cooperative Extension nutrition educators who deliver the Faithful Families Thriving Communities curriculum to the faith community.
11330468|NCT03463941|EG000|Reported Event|African American Church Members|"Peer Support Dyad Intervention: Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed."
11330469|NCT03464383|BG000|Baseline|Epileptologist-Driven Treatment|The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
11330470|NCT03464383|BG001|Baseline|Standard of Care|"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.~Referral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."
11330471|NCT03464383|BG002|Baseline|Survey Arm|"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.~Survey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."
11330472|NCT03464383|BG003|Baseline|Total|Total of all reporting groups
11330473|NCT03464383|FG000|Participant Flow|Epileptologist-Driven Treatment|The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
11330474|NCT03464383|FG001|Participant Flow|Standard of Care|"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.~Referral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."
11335765|NCT03556579|BG000|Baseline|Safety Population|All Subjects that were Fit with at least one study lens.
11330475|NCT03464383|FG002|Participant Flow|Survey Arm|"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.~Survey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."
11330476|NCT03464383|OG000|Outcome|Epileptologist-Driven Treatment|The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
11330477|NCT03464383|OG001|Outcome|Standard of Care|"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.~Referral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."
11330478|NCT03464383|OG002|Outcome|Survey Arm|"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.~Survey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."
11330479|NCT03464383|OG000|Outcome|Epileptologist-Driven Treatment Plus Standard of Care Arm|Combined treatment arms
11330480|NCT03464383|EG000|Reported Event|Epileptologist-Driven Treatment|The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
11330481|NCT03464383|EG001|Reported Event|Standard of Care|"A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.~Referral to Psychiatry: Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance."
11330482|NCT03464383|EG002|Reported Event|Survey Arm|"This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.~Survey only: One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study."
11330483|NCT03464422|BG000|Baseline|ESTEEM ConneCT|ESTEEM ConneCT group therapy intervention
11330484|NCT03464422|FG000|Participant Flow|ESTEEM conneCT|ESTEEM conneCT group therapy intervention
11330485|NCT03464422|OG000|Outcome|ESTEEM ConneCT|ESTEEM ConneCT group therapy intervention
11330486|NCT03464422|OG000|Outcome|ESTEEM ConneCT|ESTEEM ConneCT group therapy
11330487|NCT03464422|OG000|Outcome|ESTEEM conneCT|ESTEEM connect group therapy intervention
11330488|NCT03464422|EG000|Reported Event|ESTEEM conneCT|ESTEEM conneCT group therapy intervention
11330489|NCT03465436|BG000|Baseline|Sequence 1 ABDC|"Day 1 of each treatment period with a washout period of 7-14 days.~A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched"
11330490|NCT03465436|BG001|Baseline|Sequence 2 BCAD|"Day 1 of each treatment period with a washout period of 7-14 days.~B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)"
11330491|NCT03465436|BG002|Baseline|Sequence 3 CDBA|"Day 1 of each treatment period with a washout period of 7-14 days.~C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO"
11330492|NCT03465436|BG003|Baseline|Sequence 4 DACB|"Day 1 of each treatment period with a washout period of 7-14 days.~D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO"
11330493|NCT03465436|BG004|Baseline|Total|Total of all reporting groups
11330494|NCT03465436|FG000|Participant Flow|Sequence 1 ABDC|"Day 1 of each treatment period with a washout period of 7-14 days.~A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched"
11330495|NCT03465436|FG001|Participant Flow|Sequence 2 BCAD|"Day 1 of each treatment period with a washout period of 7-14 days.~B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)"
11330496|NCT03465436|FG002|Participant Flow|Sequence 3 CDBA|"Day 1 of each treatment period with a washout period of 7-14 days.~C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO"
11330497|NCT03465436|FG003|Participant Flow|Sequence 4 DACB|"Day 1 of each treatment period with a washout period of 7-14 days.~D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO"
11330498|NCT03465436|OG000|Outcome|100 mg Lasmiditan|100 mg lasmiditan administered PO in 1 of 4 treatment periods
11330499|NCT03465436|OG001|Outcome|400 mg Lasmiditan|400 mg lasmiditan administered PO in 1 of 4 treatment periods
11330500|NCT03465436|OG002|Outcome|Placebo|Placebo administered PO in 1 of 4 treatment periods.
11330501|NCT03465436|OG003|Outcome|Moxifloxacin|Moxifloxacin administered PO in 1 of 4 treatment periods.
11330502|NCT03465436|OG000|Outcome|100 mg Lasmiditan|100 mg lasmiditan administered PO in 1 of 4 treatment periods.
11330503|NCT03465436|OG001|Outcome|400 mg Lasmiditan|400 mg lasmiditan administered PO in 1 of 4 treatment periods.
11330504|NCT03465436|EG000|Reported Event|100 mg Lasmiditan|100 mg lasmiditan administered PO in 1 of 4 treatment periods.
11330505|NCT03465436|EG001|Reported Event|400 mg Lasmiditan|400 mg lasmiditan administered PO in 1 of 4 treatment periods.
11330506|NCT03465436|EG002|Reported Event|Placebo|Placebo administered PO in 1 of 4 treatment periods.
11330507|NCT03465436|EG003|Reported Event|Moxifloxacin|Moxifloxacin administered PO in 1 of 4 treatment periods.
11330508|NCT03465709|BG000|Baseline|15 mg Pegcetacoplan|IVT injections of 15 mg pegcetacoplan once monthly for 12 months, followed by a 6-month safety follow-up period.
11330509|NCT03465709|FG000|Participant Flow|15 mg Pegcetacoplan|Intravitreal (IVT) injections of 15 milligrams (mg) pegcetacoplan once monthly for 12 months, followed by a 6-month safety follow-up period.
11330510|NCT03465709|OG000|Outcome|15 mg Pegcetacoplan|IVT injections of 15 mg pegcetacoplan once monthly for 12 months, followed by a 6-month safety follow-up period.
11330511|NCT03465709|EG000|Reported Event|15 mg Pegcetacoplan: Ocular Study Eye|Ocular TEAEs are summarized for the study eye for all subjects who received IVT injections of 15 mg pegcetacoplan once monthly for 12 months.
11330512|NCT03465709|EG001|Reported Event|15 mg Pegcetacoplan: Ocular Fellow Eye|Ocular TEAEs are summarized for the fellow eye for all subjects who received IVT injections of 15 mg pegcetacoplan once monthly for 12 months.
11330513|NCT03465709|EG002|Reported Event|15 mg Pecgectacoplan: Non-ocular|Non-ocular (systemic) TEAEs are summarized for all subjects who received IVT injections of 15 mg pegcetacoplan once monthly for 12 months.
11330514|NCT03465722|BG000|Baseline|Avapritinib|"300 mg PO QD~avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously."
11330515|NCT03465722|BG001|Baseline|Regorafinib|"160 mg PO QD~regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off)."
11330516|NCT03465722|BG002|Baseline|Total|Total of all reporting groups
11330517|NCT03465722|FG000|Participant Flow|Avapritinib|"300 mg PO QD~avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously."
11330518|NCT03465722|FG001|Participant Flow|Regorafinib|"160 mg PO QD~regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off)."
11330519|NCT03465722|OG000|Outcome|Avapritinib|"300 mg PO QD~avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously."
11330520|NCT03465722|OG001|Outcome|Regorafinib|"160 mg PO QD~regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off)."
11330521|NCT03465722|EG000|Reported Event|Avapritinib|"300 mg PO QD~avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously."
11330522|NCT03465722|EG001|Reported Event|Regorafinib|"160 mg PO QD~regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off)."
11330523|NCT03465878|BG000|Baseline|Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.
11330524|NCT03465878|BG001|Baseline|Part B|Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump.
11330525|NCT03465878|BG002|Baseline|Total|Total of all reporting groups
11330526|NCT03465878|FG000|Participant Flow|Sequence 1-Part A|"Participants received either single 0.2 units per kilogram (U/kg) of body weight subcutaneous (SC) bolus injection of 100 units per milliliter (U/mL) LY900014 or Humalog.~Period 1: LY900014 Period 2: Humalog"
11330527|NCT03465878|FG001|Participant Flow|Sequence 2-Part A|"Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog.~Period 1: Humalog Period 2: LY900014"
11330528|NCT03465878|FG002|Participant Flow|Sequence 1-Part B|"Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog delivered using the continuous subcutaneous insulin infusion (CSII) pump.~Period 1: LY900014 Period 2: Humalog"
11330529|NCT03465878|FG003|Participant Flow|Sequence 2-Part B|"Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump.~Period 1: Humalog Period 2: LY900014"
11330530|NCT03465878|OG000|Outcome|Children-LY900014-Part A|Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
11330531|NCT03465878|OG001|Outcome|Children-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330532|NCT03465878|OG002|Outcome|Adolescents-LY900014-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
11330533|NCT03465878|OG003|Outcome|Adolescents-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330534|NCT03465878|OG004|Outcome|Adults-LY900014-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
11330535|NCT03465878|OG005|Outcome|Adults-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330536|NCT03465878|OG006|Outcome|Children-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330537|NCT03465878|OG007|Outcome|Children-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330538|NCT03465878|OG008|Outcome|Adolescents-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330539|NCT03465878|OG009|Outcome|Adolescents-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330540|NCT03465878|OG010|Outcome|Adults-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330541|NCT03465878|OG011|Outcome|Adults-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330542|NCT03465878|EG000|Reported Event|Children-LY900014-Part A|Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
11330543|NCT03465878|EG001|Reported Event|Children-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330544|NCT03465878|EG002|Reported Event|Adolescents-LY900014-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
11330545|NCT03465878|EG003|Reported Event|Adolescents-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330546|NCT03465878|EG004|Reported Event|Adults-LY900014-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
11330547|NCT03465878|EG005|Reported Event|Adults-Humalog-Part A|Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
11330548|NCT03465878|EG006|Reported Event|Children-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330549|NCT03465878|EG007|Reported Event|Children-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330550|NCT03465878|EG008|Reported Event|Adolescents-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330551|NCT03465878|EG009|Reported Event|Adolescents-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330552|NCT03465878|EG010|Reported Event|Adults-LY900014-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
11330553|NCT03465878|EG011|Reported Event|Adults-Humalog-Part B|Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
11330554|NCT03465904|BG000|Baseline|Verum|"2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation."
11330555|NCT03465904|BG001|Baseline|Sham|"2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation."
11330556|NCT03465904|BG002|Baseline|Total|Total of all reporting groups
11330557|NCT03465904|FG000|Participant Flow|Verum|"2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation."
11330558|NCT03465904|FG001|Participant Flow|Sham|"2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation."
11330559|NCT03465904|OG000|Outcome|Verum|"2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation."
11330560|NCT03465904|OG001|Outcome|Sham|"2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation."
11330561|NCT03465904|EG000|Reported Event|Verum|"2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation."
11330562|NCT03465904|EG001|Reported Event|Sham|"2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack~Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation."
11335766|NCT03556579|FG000|Participant Flow|OD:Test, OS:Control/ OD:Test, OS:Control|Subjects that were randomized to receive the Test lens in their right eye and the Control lens in their left eye at both visit 1 and visit 2.
11330563|NCT03466047|BG000|Baseline|Interventions|Encapsulated macronutrients in a drink, 6 experiments, Protein released in the stomach (1 day), Protein released in the small intestine (1 day), CHO released in the stomach (1 day), CHO released in the small intestine (1 day), Fat released in the stomach (1 day), fat released in the small intestine (1 day).
11330564|NCT03466047|FG000|Participant Flow|Interventions|6 interventions
11330565|NCT03466047|OG000|Outcome|Protein Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330566|NCT03466047|OG001|Outcome|Fat Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330567|NCT03466047|OG002|Outcome|CHO Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330568|NCT03466047|OG003|Outcome|Protein Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330569|NCT03466047|OG004|Outcome|Fat Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330570|NCT03466047|OG005|Outcome|CHO Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330571|NCT03466047|OG000|Outcome|Protein Stomach|"Encapsulated protein released in the stomach~Protein stomach: encapsulated protein stomach"
11330572|NCT03466047|OG001|Outcome|Protein Distal Small Intestine|"Encapsulated protein released in the distal small intestine~Protein distal small intestine: encapsulated protein distal small intestine"
11330573|NCT03466047|OG002|Outcome|CHO Stomach|"Encapsulated CHO released in the stomach~CHO stomach: encapsulated CHO stomach"
11330574|NCT03466047|OG003|Outcome|CHO Distal Small Intestine|"Encapsulated CHO released in the distal small intestine~CHO distal small intestine: encapsulated CHO distal small intestine"
11330575|NCT03466047|OG004|Outcome|Fat Stomach|"Encapsulated Fat released in the stomach~Fat stomach: encapsulated Fat stomach"
11330576|NCT03466047|OG005|Outcome|Fat Distal Small Intestine|"Encapsulated Fat released in the distal small intestine~Fat distal small intestine: encapsulated Fat distal small intestine"
11330577|NCT03466047|OG000|Outcome|Protein Stomach|Encapsulated protein released in the stomach
11330578|NCT03466047|OG001|Outcome|Protein Small Intestine|Encapsulated protein released in small intestine
11330579|NCT03466047|OG002|Outcome|CHO Stomach|CHO released in the stomach
11330580|NCT03466047|OG003|Outcome|CHO Small Intestine|Encapsulated CHO released in the small intestine
11330581|NCT03466047|OG004|Outcome|Fat Stomach|Encapsulated fat released in the stomach
11330582|NCT03466047|OG005|Outcome|Fat Small Intestine|Encapsulated fat released in the small intestine
11330583|NCT03466047|EG000|Reported Event|Protein Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330584|NCT03466047|EG001|Reported Event|Fat Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330585|NCT03466047|EG002|Reported Event|CHO Stomach|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330586|NCT03466047|EG003|Reported Event|Protein Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330587|NCT03466047|EG004|Reported Event|Fat Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330588|NCT03466047|EG005|Reported Event|CHO Distal Small Intestine|"encapsulated protein made up into a flavored water drink~A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink"
11330589|NCT03466060|BG000|Baseline|Etafilcon A|Subjects that wore the etafilcon A lens during the entire study.
11330590|NCT03466060|BG001|Baseline|Senofilcon A|Subjects that wore the senofilcon A lens during the entire study.
11330591|NCT03466060|BG002|Baseline|Senofilcon C|Subjects that wore the senofilcon C lens during the entire study.
11330592|NCT03466060|BG003|Baseline|Total|Total of all reporting groups
11330593|NCT03466060|FG000|Participant Flow|Etafilcon A-Opti-Free/Clear Care|Subjects that were dispensed the etafilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330594|NCT03466060|FG001|Participant Flow|Etafilcon A-Clear Care/Opti-Free|Subjects that were dispensed the etafilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330595|NCT03466060|FG002|Participant Flow|Senofilcon A-Opti-free/Clear Care|Subjects that were dispensed the senofilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330596|NCT03466060|FG003|Participant Flow|Senofilcon A-Clear Care/Opti-Free|Subjects that were dispensed the senofilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330597|NCT03466060|FG004|Participant Flow|Senofilcon C-Opti-Free/Clear Care|Subjects that were dispensed the senofilcon C lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330598|NCT03466060|FG005|Participant Flow|Senofilcon C-Clear Care/Opti-Free|Subjects that were dispensed the senofilcon C lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.
11330599|NCT03466060|OG000|Outcome|Revita- Lens|All subject eyes that wore contact lenses pre-soaked in Revita-lens solution up to 2 hours regardless of the lens type.
11330600|NCT03466060|OG001|Outcome|Clear Care|All subject eyes that wore contact lenses pre-soaked in Clear Care solution up to 2 hours regardless of the lens type.
11330601|NCT03466060|OG002|Outcome|Opti-Free|All subjects eyes that wore contact lenses pre-soaked in Opit-Free solution up to 2 hours regardless of the lens type.
11330602|NCT03466060|EG000|Reported Event|Etafilcon A - Revitalens|Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.
11330603|NCT03466060|EG001|Reported Event|Etafilcon A - Clear Care|Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.
11330604|NCT03466060|EG002|Reported Event|Etafilcon A- Optifree|Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the OPti-Free solution in one duringeither period 1 or period 2 during the study.
11330605|NCT03466060|EG003|Reported Event|Senofilcon A - Revitalens|Subjects that wore the senfilcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.
11330606|NCT03466060|EG004|Reported Event|Senofilcon A - ClearCare|Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.
11330607|NCT03466060|EG005|Reported Event|Senofilcon A - Opti-Free|Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.
11330608|NCT03466060|EG006|Reported Event|Senofilcon C- Revitalens|Subjects that wore the senofilcon C lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.
11330609|NCT03466060|EG007|Reported Event|Senofilcon C - ClearCare|Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.
11330610|NCT03466060|EG008|Reported Event|Senofilcon C - OptiFree|Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.
11330611|NCT03466073|BG000|Baseline|6 mg/kg Rhu-pGSN Single Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
11330612|NCT03466073|BG001|Baseline|Placebo Single Dose|Intravenous administration of placebo (NSS) in addition to standard of care
11330613|NCT03466073|BG002|Baseline|6 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
11330614|NCT03466073|BG003|Baseline|12 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
11330615|NCT03466073|BG004|Baseline|24 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
11330616|NCT03466073|BG005|Baseline|Placebo Multiple Ascending Dose|Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
11330617|NCT03466073|BG006|Baseline|Total|Total of all reporting groups
11330618|NCT03466073|FG000|Participant Flow|6 mg/kg Rhu-pGSN Single Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
11330619|NCT03466073|FG001|Participant Flow|Placebo Single Dose|Intravenous administration of placebo (NSS) in addition to standard of care
11330620|NCT03466073|FG002|Participant Flow|6 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
11330621|NCT03466073|FG003|Participant Flow|12 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
11330622|NCT03466073|FG004|Participant Flow|24 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
11330623|NCT03466073|FG005|Participant Flow|Placebo Multiple Ascending Dose|Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
11330624|NCT03466073|OG000|Outcome|6 mg/kg Rhu-pGSN Single Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
11330625|NCT03466073|OG001|Outcome|Placebo Single Dose|Intravenous administration of placebo (NSS) in addition to standard of care
11330626|NCT03466073|OG002|Outcome|6 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
11330627|NCT03466073|OG003|Outcome|12 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
11330628|NCT03466073|OG004|Outcome|24 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
11330629|NCT03466073|OG005|Outcome|Placebo Multiple Ascending Dose|Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
11330630|NCT03466073|OG000|Outcome|6 mg/kg Rhu-pGSN|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care (single dose and multiple doses once a day for 3 consecutive days)
11330631|NCT03466073|OG001|Outcome|12 mg/kg Rhu-pGSN|Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
11330632|NCT03466073|OG002|Outcome|24 mg/kg Rhu-pGSN|Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
11330633|NCT03466073|OG000|Outcome|Combined Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg,12 mg/kg & 24mg/kg in addition to standard of care once a day for 3 consecutive days
11330634|NCT03466073|OG001|Outcome|Combined Placebo Multiple Ascending Dose|Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
11330635|NCT03466073|OG002|Outcome|6 mg/kg Rhu-pGSN Single Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
11330636|NCT03466073|OG003|Outcome|Placebo Single Dose|Intravenous administration of placebo (NSS) in addition to standard of care
11330637|NCT03466073|EG000|Reported Event|6 mg/kg Rhu-pGSN Single Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
11330638|NCT03466073|EG001|Reported Event|Placebo Single Dose|Intravenous administration of placebo (NSS) in addition to standard of care
11330639|NCT03466073|EG002|Reported Event|6 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
11330640|NCT03466073|EG003|Reported Event|12 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
11330641|NCT03466073|EG004|Reported Event|24 mg/kg Rhu-pGSN Multiple Ascending Dose|Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
11330642|NCT03466073|EG005|Reported Event|Placebo Multiple Ascending Dose|Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
11330643|NCT03466086|BG000|Baseline|Dispensed Subjects|All subjects dispensed at least one eye drop and 1 contact lens
11330644|NCT03466086|FG000|Participant Flow|Test/Control|Subjects randomized to this sequence received the Test eye drop during the first period and then received the Control eye drop during the second period.
11330645|NCT03466086|FG001|Participant Flow|Control/Test|Subjects randomized to this sequence received the Control eye drop during the first period and then received the Test eye drop during the second period.
11330646|NCT03466086|OG000|Outcome|Test|All subjects that wore the Test eye drop during either the first or second period of the study.
11330647|NCT03466086|OG001|Outcome|Control|All subjects that wore the control eye drop in either the first or second period of the study.
11330648|NCT03466086|EG000|Reported Event|Test|All subjects that wore the Test eye drop during either period 1 or period 2 during the study.
11330649|NCT03466086|EG001|Reported Event|Control|All subjects that wore the Control eye drop during either period 1 or period 2 during the study.
11330650|NCT03466099|BG000|Baseline|KVD001 Injection (High Dose)|KVD001 Injection: Intravitreal KVD001 Injection 6ug
11330651|NCT03466099|BG001|Baseline|KVD001 Injection (Low Dose)|KVD001 Injection: Intravitreal KVD001 Injection 3ug
11330652|NCT03466099|BG002|Baseline|Sham Procedure|Sham Procedure: Sham Procedure
11330653|NCT03466099|BG003|Baseline|Total|Total of all reporting groups
11330654|NCT03466099|FG000|Participant Flow|KVD001 Injection (High Dose)|KVD001 Injection: Intravitreal KVD001 6μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
11330655|NCT03466099|FG001|Participant Flow|KVD001 Injection (Low Dose)|KVD001 Injection: Intravitreal KVD001 3μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
11330656|NCT03466099|FG002|Participant Flow|Sham Procedure|Sham Procedure: Sham Procedure performed on the study eye on Day 1 and Weeks 4, 8 and 12 which involved preparing the study subject in the same manner as a real injection would be prepared (i.e., including but not limited to insertion of lid speculum, application of povidone-iodine, and subconjunctival injection of an anesthetic, all applied to the study eye) after which an empty syringe without an attached needle was pressed against the eye to mimic the pressure of an injection
11330657|NCT03466099|OG000|Outcome|KVD001 Injection (High Dose)|KVD001 Injection: Intravitreal KVD001 Injection 6ug
11330658|NCT03466099|OG001|Outcome|KVD001 Injection (Low Dose)|KVD001 Injection: Intravitreal KVD001 Injection 3ug
11330659|NCT03466099|OG002|Outcome|Sham Procedure|Sham Procedure: Sham Procedure
11330660|NCT03466099|EG000|Reported Event|KVD001 Injection (High Dose)|KVD001 Injection: Intravitreal KVD001 Injection 6ug
11330661|NCT03466099|EG001|Reported Event|KVD001 Injection (Low Dose)|KVD001 Injection: Intravitreal KVD001 Injection 3ug
11330662|NCT03466099|EG002|Reported Event|Sham Procedure|Sham Procedure: Sham Procedure
11330663|NCT03466918|BG000|Baseline|Patients With SAPIEN 3 THV|Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
11330664|NCT03466918|FG000|Participant Flow|Patients With SAPIEN 3 THV|Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
11330665|NCT03466918|OG000|Outcome|Patients With SAPIEN 3 THV|Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
11330666|NCT03466918|OG000|Outcome|Patients With SAPIEN 3 THV|Patients will be implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
11330667|NCT03466918|EG000|Reported Event|Patients With SAPIEN 3 THV|Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
11330668|NCT03467048|BG000|Baseline|McGrath Videolaryngoscopy|"Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)~McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330669|NCT03467048|BG001|Baseline|Direct Laryngoscopy|"Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)~Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330670|NCT03467048|BG002|Baseline|Total|Total of all reporting groups
11330671|NCT03467048|FG000|Participant Flow|McGrath Videolaryngoscopy|"Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)~McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330672|NCT03467048|FG001|Participant Flow|Direct Laryngoscopy|"Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)~Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330673|NCT03467048|OG000|Outcome|McGrath Videolaryngoscopy|"Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)~McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330674|NCT03467048|OG001|Outcome|Direct Laryngoscopy|"Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)~Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330675|NCT03467048|EG000|Reported Event|McGrath Videolaryngoscopy|"Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)~McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330676|NCT03467048|EG001|Reported Event|Direct Laryngoscopy|"Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)~Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
11330677|NCT03467217|BG000|Baseline|Losartan Potassium Capsule|"Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to <150 kg.~Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype"
11330678|NCT03467217|BG001|Baseline|Placebo Losartan Capsule|"Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to <150 kg.~Placebo losartan capsule: Matching placebo losartan oral capsule"
11330679|NCT03467217|BG002|Baseline|Total|Total of all reporting groups
11330680|NCT03467217|FG000|Participant Flow|Losartan|100 mg losartan once per day
11330681|NCT03467217|FG001|Participant Flow|Placebo|Matching placebo, taken once per day
11330682|NCT03467217|OG000|Outcome|Losartan Potassium Capsule|"Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to <150 kg.~Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype"
11330683|NCT03467217|OG001|Outcome|Placebo Losartan Capsule|"Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to <150 kg.~Placebo losartan capsule: Matching placebo losartan oral capsule"
11330684|NCT03467217|EG000|Reported Event|Losartan|100 mg losartan once per day
11330685|NCT03467217|EG001|Reported Event|Placebo|Matching placebo, taken once per day
11330686|NCT03467412|BG000|Baseline|Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment|In total 60 subjects were recruited. Each subject received 2 treatments in parallell on 2 different treatment areas. Baseline characteristics can therefore not be described for the individual treatment groups as they refer to treatment areas and not subjects. Hence, baseline characteristics are only reported for the total number of recruited subjects, i.e. 60.
11330687|NCT03467412|FG000|Participant Flow|0.00625 μg FOL-005|"50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330688|NCT03467412|FG001|Participant Flow|0.025 μg FOL-005|"50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330689|NCT03467412|FG002|Participant Flow|0.050 μg FOL-005|"50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330690|NCT03467412|FG003|Participant Flow|0.100 μg FOL-005|"50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330691|NCT03467412|FG004|Participant Flow|Placebo|"50 μl solution (placebo) injected intradermally three times per week for 12 weeks.~Placebo: intradermal injection"
11330692|NCT03467412|OG000|Outcome|0.00625 μg FOL-005|"50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330693|NCT03467412|OG001|Outcome|0.025 μg FOL-005|"50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330694|NCT03467412|OG002|Outcome|0.050 μg FOL-005|"50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330695|NCT03467412|OG003|Outcome|0.100 μg FOL-005|"50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330696|NCT03467412|OG004|Outcome|Placebo|"50 μl solution (placebo) injected intradermally three times per week for 12 weeks.~Placebo: intradermal injection"
11330697|NCT03467412|OG000|Outcome|0.00625 μg FOL-005|"0.00625 μg FOL-005, solution. 50 μl injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330698|NCT03467412|OG001|Outcome|0.025 μg FOL-005|"0.025 μg FOL-005, solution. 50 μl injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330699|NCT03467412|OG002|Outcome|0.050 μg FOL-005|"0.050 μg FOL-005, solution. 50 μl injected intradermallys three times per week for 12 weeks.~FOL-005: intradermal injection"
11330700|NCT03467412|OG003|Outcome|0.100 μg FOL-005|"0.100 μg FOL-005, solution. 50 μl injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330701|NCT03467412|OG004|Outcome|Placebo|"Placebo. 50 μl injected intradermally three times per week for 12 weeks.~Placebo: intradermal injection"
11330702|NCT03467412|OG002|Outcome|0.050 μg FOL-005|"0.050 μg FOL-005, solution. 50 μl injected intradermally three times per week for 12 weeks.~FOL-005: intradermal injection"
11330703|NCT03467412|EG000|Reported Event|0.00625 μg FOL-005|"0.00625 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.~FOL-005: intradermal injection"
11330704|NCT03467412|EG001|Reported Event|0.025 μg FOL-005|"0.025 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.~FOL-005: intradermal injection"
11330705|NCT03467412|EG002|Reported Event|0.050 μg FOL-005|"0.050 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.~FOL-005: intradermal injection"
11330706|NCT03467412|EG003|Reported Event|0.100 μg FOL-005|"0.100 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.~FOL-005: intradermal injection"
11330707|NCT03467412|EG004|Reported Event|Placebo|"Placebo. 50 μl injected sub-cutaneous three times per week for 12 weeks.~Placebo: intradermal injection"
11330708|NCT03467412|EG005|Reported Event|Systemic Adverse Events|"The systemic (or non-local) AEs are reported for the whole group (60 subjects) only. these events can not be related to one dose strengthe since all subjects received more than one dose.~Dose range for this group range from 0.0065 μg (subjects receiving a combination of the lowest dose and placebo) to 0.150 μg (subjects receiving a combination of the 2 highest doses)"
11330709|NCT03467425|BG000|Baseline|FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI|Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330710|NCT03467425|BG001|Baseline|Non-ELLIPTA MITT|Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330711|NCT03467425|BG002|Baseline|Total|Total of all reporting groups
11330712|NCT03467425|FG000|Participant Flow|FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI|Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330713|NCT03467425|FG001|Participant Flow|Non-ELLIPTA MITT|Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330714|NCT03467425|OG000|Outcome|FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI|Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330715|NCT03467425|OG001|Outcome|Non-ELLIPTA MITT|Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330716|NCT03467425|EG000|Reported Event|FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI|Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330717|NCT03467425|EG001|Reported Event|Non-Ellipta MITT|Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
11330718|NCT03467477|BG000|Baseline|Early Symptomatic AD Subjects|Early Symptomatic AD subjects in the flortaucipir PET scan arm
11330719|NCT03467477|FG000|Participant Flow|Early Symptomatic AD Subjects|Early Symptomatic AD subjects in the flortaucipir PET scan arm
11330720|NCT03467477|OG000|Outcome|Early Symptomatic AD, Eligible for Future Trials|Subjects determined to be eligible for future studies from the flortaucipir PET scan arm.
11330721|NCT03467477|OG001|Outcome|Early Symptomatic AD, Ineligible for Future Trials|Subjects who were not eligible for future studies from the flortaucipir PET scan arm.
11330722|NCT03467477|OG002|Outcome|Early Symptomatic AD, Not Evaluable|Subjects determined to be not eligible for future studies from the flortaucipir PET scan arm due to unevaluable PET scan for quantitation
11330723|NCT03467477|OG003|Outcome|Early Symptomatic AD (Total)|All subjects with early symptomatic AD from the flortaucipir PET scan arm
11330724|NCT03467477|EG000|Reported Event|Safety Analysis Population|All subjects with early symptomatic AD from the flortaucipir PET scan arm who received one dose of flortaucipir
11330725|NCT03467685|BG000|Baseline|VAD Off Arm|"This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330726|NCT03467685|BG001|Baseline|VAD On Arm|"This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330727|NCT03467685|BG002|Baseline|Total|Total of all reporting groups
11330728|NCT03467685|FG000|Participant Flow|VAD Off Arm|"This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330729|NCT03467685|FG001|Participant Flow|VAD On Arm|"This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330730|NCT03467685|OG000|Outcome|VAD Off Arm|"This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330731|NCT03467685|OG001|Outcome|VAD On Arm|"This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330732|NCT03467685|EG000|Reported Event|VAD Off Arm|"This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330733|NCT03467685|EG001|Reported Event|VAD On Arm|"This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration~Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz"
11330734|NCT03467763|BG000|Baseline|Metformin Hydrochloride Extended Release and Placebo|"Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg. Individual encapsulations of metformin will contain dosages of 250 mg or 500 mg.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of placebo, followed by 500 mg placebo, 750 mg, and 1,000 mg placebo with each treatment period separated by a 2-week course of metformin XR in the same increments of dosage.~Placebo oral capsule: Placebo capsule"
11330735|NCT03467763|FG000|Participant Flow|Metformin Hydrochloride Extended Release and Placebo|"Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg. Individual encapsulations of metformin will contain dosages of 250 mg or 500 mg.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of placebo, followed by 500 mg placebo, 750 mg, and 1,000 mg placebo with each treatment period separated by a 2-week course of metformin XR in the same increments of dosage.~Placebo oral capsule: Placebo capsule"
11330736|NCT03467763|OG000|Outcome|Metformin Hydrochloride Extended Release|"Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg.~Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion. The resulting regimen was 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~This arm includes only the person-time exposed to metformin XR."
11330737|NCT03467763|OG001|Outcome|Placebo|"Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg.~Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion. The resulting regimen was 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~This arm includes only the person-time exposed to placebo."
11330738|NCT03467763|OG000|Outcome|Metformin Hydrochloride Extended Release and Placebo|"Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg. Individual encapsulations of metformin will contain dosages of 250 mg or 500 mg.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of placebo, followed by 500 mg placebo, 750 mg, and 1,000 mg placebo with each treatment period separated by a 2-week course of metformin XR in the same increments of dosage.~Placebo oral capsule: Placebo capsule"
11330739|NCT03467763|EG000|Reported Event|Metformin Hydrochloride Extended Release and Placebo|"Participants took their baseline medication plus escalating doses of metformin in 250 mg increments, alternating with placebo in a randomized, double-blinded fashion.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo.~Metformin Extended Release Oral Tablet: Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg. Individual encapsulations of metformin will contain dosages of 250 mg or 500 mg.~Patients were assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of placebo, followed by 500 mg placebo, 750 mg, and 1,000 mg placebo with each treatment period separated by a 2-week course of metformin XR in the same increments of dosage.~Placebo oral capsule: Placebo capsule"
11330740|NCT03467945|BG000|Baseline|Treatment Sequence 1|Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330741|NCT03467945|BG001|Baseline|Treatment Sequence 2|Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330742|NCT03467945|BG002|Baseline|Treatment Sequence 3|Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330743|NCT03467945|BG003|Baseline|Treatment Sequence 4|Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330744|NCT03467945|BG004|Baseline|Total|Total of all reporting groups
11330745|NCT03467945|FG000|Participant Flow|Treatment Sequence 1|Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330746|NCT03467945|FG001|Participant Flow|Treatment Sequence 2|Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330747|NCT03467945|FG002|Participant Flow|Treatment Sequence 3|Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330748|NCT03467945|FG003|Participant Flow|Treatment Sequence 4|Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period.
11330749|NCT03467945|OG000|Outcome|Metformin-Gliclazide Combination|Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet either in treatment period 1, 2, 3 or 4.
11330750|NCT03467945|OG001|Outcome|Metformin and Gliclazide Separately|Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg separately either in treatment period 1, 2, 3 or 4.
11330751|NCT03467945|OG002|Outcome|Metformin|Participants received single oral dose of metformin 1000 mg either in treatment period 1, 2, 3 or 4.
11330752|NCT03467945|OG002|Outcome|Gliclazide|Participants received single oral dose of gliclazide 30mg either in treatment period 1, 2, 3 or 4.
11330753|NCT03467945|OG003|Outcome|Gliclazide|Participants received single oral dose of gliclazide 30mg either in treatment period 1, 2, 3 or 4.
11330754|NCT03467945|EG000|Reported Event|Metformin-Gliclazide Combination|Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet either in treatment period 1, 2, 3 or 4.
11330755|NCT03467945|EG001|Reported Event|Metformin and Gliclazide Separately|Participants received single oral dose of metformin 1000 mg and gliclazide 30 mg separately either in treatment period 1, 2, 3 or 4.
11330756|NCT03467945|EG002|Reported Event|Metformin|Participants received single oral dose of metformin 1000 mg either in treatment period 1, 2, 3 or 4.
11330757|NCT03467945|EG003|Reported Event|Gliclazide|Participants received single oral dose of gliclazide 30mg either in treatment period 1, 2, 3 or 4.
11330758|NCT03467971|BG000|Baseline|Metformin-Gliclazide (Fasted), Then Metformin-Gliclazide (Fed)|Participants received single dose of Metformin 1000 milligram (mg) and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 2. Each treatment period was separated by a 14-day wash-out period.
11330759|NCT03467971|BG001|Baseline|Metformin-Gliclazide (Fed), Then Metformin-Gliclazide (Fasted)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 2. Each treatment period will be separated by a 14-day wash-out period.
11330760|NCT03467971|BG002|Baseline|Total|Total of all reporting groups
11330761|NCT03467971|FG000|Participant Flow|Metformin-Gliclazide (Fasted), Then Metformin-Gliclazide (Fed)|Participants received single dose of Metformin 1000 milligram (mg) and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 2. Each treatment period was separated by a 14-day wash-out period.
11330762|NCT03467971|FG001|Participant Flow|Metformin-Gliclazide (Fed), Then Metformin-Gliclazide (Fasted)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 2. Each treatment period will be separated by a 14-day wash-out period.
11330763|NCT03467971|OG000|Outcome|Metformin-Gliclazide (Fasted)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 1 or in treatment period 2.
11330764|NCT03467971|OG001|Outcome|Metformin-Gliclazide (Fed)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 1 or in treatment period 2.
11330765|NCT03467971|OG000|Outcome|Metformin-Gliclazide (Fasted)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasted state in treatment period 1 or in treatment period 2.
11330766|NCT03467971|EG000|Reported Event|Metformin-Gliclazide (Fasted)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 1 or in treatment period 2.
11330767|NCT03467971|EG001|Reported Event|Metformin-Gliclazide (Fed)|Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 1 or in treatment period 2.
11330768|NCT03468075|BG000|Baseline|Gemcitabine + High-Dose Ascorbate|"Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.~Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle~Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate"
11330769|NCT03468075|FG000|Participant Flow|Gemcitabine + High-Dose Ascorbate|"Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.~Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle~Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate"
11330770|NCT03468075|OG000|Outcome|Gemcitabine + High-Dose Ascorbate|"Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.~Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle~Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate"
11330771|NCT03468075|EG000|Reported Event|Gemcitabine + High-Dose Ascorbate|"Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.~Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle~Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate"
11330772|NCT03468179|BG000|Baseline|Oatmeal|"Participants will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes.~Oatmeal: Subjects will be fed a calculated serving of oatmeal."
11330773|NCT03468179|FG000|Participant Flow|Oatmeal|"Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes.~Oatmeal: Subjects will be fed a calculated serving of oatmeal."
11330774|NCT03468179|OG000|Outcome|Oatmeal|"Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes.~Oatmeal: Subjects will be fed a calculated serving of oatmeal."
11330775|NCT03468179|EG000|Reported Event|Oatmeal|"Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes.~Oatmeal: Subjects will be fed a calculated serving of oatmeal."
11330776|NCT03468543|BG000|Baseline|Cohort 1|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose~Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation will be administered orally in a single dose~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330777|NCT03468543|BG001|Baseline|Cohort 2|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation C: Memantine HCl MR capsule formulation will be administered orally in a single dose~Memantine Hydrochloride MR Prototype Capsule Formulation D: Memantine HCl MR capsule formulation will be administered orally in a single dose~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330778|NCT03468543|BG002|Baseline|Cohort 3|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation E: Memantine HCl MR capsule formulation will be administered orally in a single dose~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330779|NCT03468543|BG003|Baseline|Total|Total of all reporting groups
11330780|NCT03468543|FG000|Participant Flow|Cohort 1|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose~Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation did NOT get administered~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330781|NCT03468543|OG000|Outcome|Cohort 1|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose~Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation will be administered orally in a single dose~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330782|NCT03468543|EG000|Reported Event|Cohort 1|"Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days~Memantine Hydrochloride MR Prototype Capsule Formulation A: Memantine HCl MR capsule formulation will be administered orally in a single dose~Memantine Hydrochloride MR Prototype Capsule Formulation B: Memantine HCl MR capsule formulation was NOT administered~Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol"
11330783|NCT03468816|BG000|Baseline|A-B-A|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods.
11330784|NCT03468816|BG001|Baseline|B-A-B|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods.
11330785|NCT03468816|BG002|Baseline|Total|Total of all reporting groups
11330786|NCT03468816|FG000|Participant Flow|A-B-A|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods
11330787|NCT03468816|FG001|Participant Flow|B-A-B|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods
11330788|NCT03468816|OG000|Outcome|Variant A|Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
11330789|NCT03468816|OG001|Outcome|Variant B|Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
11330790|NCT03468816|OG000|Outcome|A-B-A|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods.
11330791|NCT03468816|OG001|Outcome|B-A-B|Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods.
11330792|NCT03468816|EG000|Reported Event|Variant A|Measure at dressing change when investigational device Absorbest moisture sensor Variant A had been used.
11330793|NCT03468816|EG001|Reported Event|Variant B|Measure at dressing change when investigational device Absorbest moisture sensor Variant B had been used.
11330794|NCT03468855|BG000|Baseline|ATI-50002 0.46% Topical Solution|"ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks~ATI-50002 0.46% topical solution: Topical Solution administered twice daily"
11330795|NCT03468855|FG000|Participant Flow|ATI-50002 0.46% Topical Solution|"ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks~ATI-50002 0.46% topical solution: Topical Solution administered twice daily"
11330796|NCT03468855|OG000|Outcome|ATI-50002 0.46% Topical Solution|"ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks~ATI-50002 0.46% topical solution: Topical Solution administered twice daily"
11330797|NCT03468855|EG000|Reported Event|ATI-50002 0.46% Topical Solution|"ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks~ATI-50002 0.46% topical solution: Topical Solution administered twice daily"
11330798|NCT03468920|BG000|Baseline|Arm 1: IV Acetaminophen Group|"Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively~IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively~PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule"
11330799|NCT03468920|BG001|Baseline|Arm 2: PO Acetaminophen Group|"Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively~PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively~IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention"
11330800|NCT03468920|BG002|Baseline|Total|Total of all reporting groups
11330801|NCT03468920|FG000|Participant Flow|Arm 1: IV Acetaminophen Group|"Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively~IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively~PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule"
11330802|NCT03468920|FG001|Participant Flow|Arm 2: PO Acetaminophen Group|"Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively~PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively~IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention"
11330803|NCT03468920|OG000|Outcome|Arm 1: IV Acetaminophen Group|"Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively~IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively~PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule"
11330804|NCT03468920|OG001|Outcome|Arm 2: PO Acetaminophen Group|"Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively~PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively~IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention"
11330805|NCT03468920|EG000|Reported Event|Arm 1: IV Acetaminophen Group|"Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively~IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively~PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule"
11330806|NCT03468920|EG001|Reported Event|Arm 2: PO Acetaminophen Group|"Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively~PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively~IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention"
11330807|NCT03468933|BG000|Baseline|Fibrinolytic Therapy Group|"Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.~tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose"
11330808|NCT03468933|BG001|Baseline|Medical Thoracoscopy Group|"Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.~Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols."
11330809|NCT03468933|BG002|Baseline|Total|Total of all reporting groups
11330810|NCT03468933|FG000|Participant Flow|Fibrinolytic Therapy Group|"Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.~tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose"
11330811|NCT03468933|FG001|Participant Flow|Medical Thoracoscopy Group|"Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.~Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols."
11330812|NCT03468933|OG000|Outcome|Fibrinolytic Therapy Group|"Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.~tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose"
11330813|NCT03468933|OG001|Outcome|Medical Thoracoscopy Group|"Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.~Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols."
11330814|NCT03468933|EG000|Reported Event|Fibrinolytic Therapy Group|"Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.~tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose"
11330815|NCT03468933|EG001|Reported Event|Medical Thoracoscopy Group|"Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.~Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols."
11330816|NCT03469336|BG000|Baseline|PF-06763809+Vehicle+Calcipotriene+Betamethasone|All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm^2), applied topically once daily to 1.1 cm^2 skin surface area of each test field during an 18-day treatment period.
11330817|NCT03469336|FG000|Participant Flow|PF-06763809+Vehicle+Calcipotriene+Betamethasone|All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm^2), applied topically once daily to 1.1 cm^2 skin surface area of each test field during an 18-day treatment period.
11330818|NCT03469336|OG000|Outcome|A: PF-06763809 2.3% Solution|Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809
11330819|NCT03469336|OG001|Outcome|B: PF-06763809 0.8% Solution|Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809
11330820|NCT03469336|OG002|Outcome|C: PF-06763809 0.23% Solution|Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.
11330821|NCT03469336|OG003|Outcome|D: PF-06763809 Vehicle|Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
11330822|NCT03469336|OG000|Outcome|PF-06763809+Vehicle+Calcipotriene+Betamethasone|All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm^2), applied topically once daily to 1.1 cm^2 skin surface area of each test field during an 18-day treatment period.
11330823|NCT03469336|OG003|Outcome|E: Calcipotriene/Calcipotriol Solution|Participants were exposed to Calcipotriene/ calcipotriol (50 g/mL) once daily during an 18-day treatment period. Daily dosage of calcipotriol: approximately 0.01 mg. Total dosage: approximately 0.18 mg.
11330824|NCT03469336|OG003|Outcome|F: Betamethasone Solution.|Participants were exposed to Betamethasone (1 mg/g) once daily during an 18-day treatment period. Daily dosage of approximately 0.18 mg. Total dosage: approximately 3.2 mg.
11330825|NCT03469336|EG000|Reported Event|PF-06763809+Vehicle+Calcipotriene+Betamethasone|All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm^2), applied topically once daily to 1.1 cm^2 skin surface area of each test field during an 18-day treatment period.
11330826|NCT03469349|BG000|Baseline|Placebo|Actovegin placebo-matching infusion, intravenously, once daily for up to 2 weeks followed by actovegin placebo-matching tablets, orally, thrice daily for up to 10 weeks.
11330827|NCT03469349|BG001|Baseline|Actovegin 1200 mg|Actovegin 1200 mg, infusion, intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (1200 mg/day) for up to 10 weeks.
11330828|NCT03469349|BG002|Baseline|Total|Total of all reporting groups
11330829|NCT03469349|FG000|Participant Flow|Placebo|Actovegin placebo-matching infusion, intravenously, once daily for up to 2 weeks followed by actovegin placebo-matching tablets, orally, thrice daily for up to 10 weeks.
11330830|NCT03469349|FG001|Participant Flow|Actovegin 1200 mg|Actovegin 1200 milligram (mg), infusion, intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (1200 mg/day) for up to 10 weeks.
11330831|NCT03469349|OG000|Outcome|Placebo|Actovegin placebo-matching infusion, intravenously, once daily for up to 2 weeks followed by actovegin placebo-matching tablets, orally, thrice daily for up to 10 weeks.
11330832|NCT03469349|OG001|Outcome|Actovegin 1200 mg|Actovegin 1200 mg, infusion, intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (1200 mg/day) for up to 10 weeks.
11330833|NCT03469349|EG000|Reported Event|Placebo|Actovegin placebo-matching infusion, intravenously, once daily for up to 2 weeks followed by actovegin placebo-matching tablets, orally, thrice daily for up to 10 weeks.
11330834|NCT03469349|EG001|Reported Event|Actovegin 1200 mg|Actovegin 1200 mg, infusion, intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (1200 mg/day) for up to 10 weeks.
11330835|NCT03470012|BG000|Baseline|Treatment Arm|"Investigational tape~Multi-Purpose Gentle Tape: The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin."
11330836|NCT03470012|FG000|Participant Flow|Treatment Arm|"Investigational tape~Multi-Purpose Gentle Tape: The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin."
11330837|NCT03470012|OG000|Outcome|Treatment Arm|"Investigational tape~Multi-Purpose Gentle Tape: The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin."
11330838|NCT03470012|EG000|Reported Event|Treatment Arm|"Investigational tape~Multi-Purpose Gentle Tape: The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin."
11330839|NCT03470194|BG000|Baseline|Interpretation Modality: In Person|"Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit~Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment"
11330840|NCT03470194|BG001|Baseline|Interpretation Modality: Telephonic|"Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit~Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment"
11330841|NCT03470194|BG002|Baseline|Total|Total of all reporting groups
11330842|NCT03470194|FG000|Participant Flow|Interpretation Modality: In Person|"Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit~Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment"
11330843|NCT03470194|FG001|Participant Flow|Interpretation Modality: Telephonic|"Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit~Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment"
11330844|NCT03470194|OG000|Outcome|Interpretation Modality: In Person|"Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit~Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment"
11330845|NCT03470194|OG001|Outcome|Interpretation Modality: Telephonic|"Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit~Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment"
11330846|NCT03470194|EG000|Reported Event|Interpretation Modality: In Person|"Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit~Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment"
11330847|NCT03470194|EG001|Reported Event|Interpretation Modality: Telephonic|"Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit~Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment"
11330848|NCT03470493|BG000|Baseline|Participants|"ApneaLink Air~ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG"
11330849|NCT03470493|FG000|Participant Flow|Participants|"ApneaLink Air~ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG"
11330850|NCT03470493|OG000|Outcome|Participants|"ApneaLink Air~ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG"
11330851|NCT03470493|EG000|Reported Event|Participants|"ApneaLink Air~ApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG"
11330852|NCT03470545|BG000|Baseline|Mavacamten (MYK-461)|mavacamten: mavacamten capsules
11330853|NCT03470545|BG001|Baseline|Placebo|Placebo: placebo oral capsule
11330854|NCT03470545|BG002|Baseline|Total|Total of all reporting groups
11330855|NCT03470545|FG000|Participant Flow|Mavacamten (MYK-461)|"Mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 8 and Week 14, mavacamten dose may have been up-titrated for individual subjects based on prespecified criteria. Down-titration was possible at Week 6, Week 8, Week 14, Week 18, Week 22 and Week 26 for individual subjects based on prespecified criteria."
11330856|NCT03470545|FG001|Participant Flow|Placebo|"Placebo: placebo capsule~One placebo-to-match mavacamten capsule once daily by mouth for 30 weeks. A universal placebo capsule to match all strengths of mavacamten had the same appearance as mavacamten capsules but did not include the active ingredient."
11330857|NCT03470545|OG000|Outcome|Mavacamten (MYK-461)|"Mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 6, Week 8, and Week 14, mavacamten dose may have been up-titrated or down-titrated for individual subjects based on prespecified criteria."
11330858|NCT03470545|OG001|Outcome|Placebo|"Placebo: placebo capsule~One placebo-to-match mavacamten capsule once daily by mouth for 30 weeks. A universal placebo capsule to match all strengths of mavacamten had the same appearance as mavacamten capsules but did not include the active ingredient."
11330859|NCT03470545|OG000|Outcome|Mavacamten (MYK-461)|"Mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 8 and Week 14, mavacamten dose may have been up-titrated for individual subjects based on prespecified criteria. Down-titration was possible at Week 6, Week 8, Week 14, Week 18, Week 22 and Week 26 for individual subjects based on prespecified criteria."
11330860|NCT03470545|EG000|Reported Event|Mavacamten (MYK-461)|"mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 6, Week 8, and Week 14, mavacamten dose may have been up-titrated or down-titrated for individual subjects based on prespecified criteria."
11330861|NCT03470545|EG001|Reported Event|Placebo|"Placebo: placebo oral capsule~One placebo-to-match mavacamten capsule once daily by mouth for 30 weeks. A universal placebo capsule to match all strengths of mavacamten had the same appearance as mavacamten capsules but did not include the active ingredient. Placebo dose to match mavacamten capsule was administered once daily by mouth."
11330862|NCT03470740|BG000|Baseline|Intervention Group|"An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.~rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation."
11330863|NCT03470740|BG001|Baseline|Control Group|The control group received general information on rheumatoid arthritis care and follow-up.
11330864|NCT03470740|BG002|Baseline|Total|Total of all reporting groups
11330865|NCT03470740|FG000|Participant Flow|Intervention Group|"An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.~rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation."
11330866|NCT03470740|FG001|Participant Flow|Control Group|The control group received general information on rheumatoid arthritis care and follow-up.
11330867|NCT03470740|OG000|Outcome|Intervention Group|"An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.~rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation."
11330868|NCT03470740|OG001|Outcome|Control Group|The control group received general information on rheumatoid arthritis care and follow-up.
11330869|NCT03470740|OG000|Outcome|Intervention Group|"An individualized rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.~rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation."
11330870|NCT03470740|EG000|Reported Event|Intervention Group|"An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.~rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation."
11330871|NCT03470740|EG001|Reported Event|Control Group|The control group received general information on rheumatoid arthritis care and follow-up.
11330872|NCT03471065|BG000|Baseline|Transcatheter Aortic Valve Replacement (TAVR)|SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
11330873|NCT03471065|FG000|Participant Flow|Transcatheter Aortic Valve Replacement (TAVR)|SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
11330874|NCT03471065|OG000|Outcome|Transcatheter Aortic Valve Replacement (TAVR)|SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
11330875|NCT03471065|EG000|Reported Event|Transcatheter Aortic Valve Replacement (TAVR)|SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
11330876|NCT03471078|BG000|Baseline|Avatrombopag|"Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.~Avatrombopag: Oral avatrombopag tablet"
11330877|NCT03471078|BG001|Baseline|Placebo|"Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.~Placebo Oral Tablet: Placebo comparator tablet"
11330878|NCT03471078|BG002|Baseline|Total|Total of all reporting groups
11330879|NCT03471078|FG000|Participant Flow|Avatrombopag|"Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg of Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.~Avatrombopag: Oral avatrombopag tablet"
11330880|NCT03471078|FG001|Participant Flow|Placebo|"Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.~Placebo Oral Tablet: Placebo comparator tablet"
11330881|NCT03471078|OG000|Outcome|Avatrombopag|Avatrombopag: Oral avatrombopag tablet
11330882|NCT03471078|OG001|Outcome|Placebo|Placebo Oral Tablet: Placebo comparator tablet
11330883|NCT03471078|EG000|Reported Event|Avatrombopag|Avatrombopag: Oral avatrombopag tablet
11330884|NCT03471078|EG001|Reported Event|Placebo|Placebo Oral Tablet: Placebo comparator tablet
11330885|NCT03471832|BG000|Baseline|Overall Study|Total Participants
11330886|NCT03471832|FG000|Participant Flow|Stenfilcon A Lens|"Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.~stenfilcon A lens: contact lens"
11330887|NCT03471832|FG001|Participant Flow|Narafilcon A Lens|"Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.~narafilcon A lens: contact lens"
11330888|NCT03471832|OG000|Outcome|Stenfilcon A Lens|"Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.~stenfilcon A lens: contact lens"
11330889|NCT03471832|OG001|Outcome|Narafilcon A Lens|"Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.~narafilcon A lens: contact lens"
11330890|NCT03471832|OG000|Outcome|Overall Study - Investigator Fitting Preference|"Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.~stenfilcon A lens: contact lens narafilcon A lens: contact lens"
11330891|NCT03471832|OG000|Outcome|Lens Preference - After Insertion|"Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.~stenfilcon A lens: contact lens"
11330892|NCT03471832|EG000|Reported Event|Stenfilcon A Lens|"Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.~stenfilcon A lens: contact lens"
11330893|NCT03471832|EG001|Reported Event|Narafilcon A Lens|"Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.~narafilcon A lens: contact lens"
11330894|NCT03471871|BG000|Baseline|HV Cohort|Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]) or lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. A washout period of 14 days was maintained between each treatment period.
11330895|NCT03471871|BG001|Baseline|OSA Cohort|Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo or one lemborexant 10 mg, tablets, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2. A washout period of 14 days was maintained between each treatment period.
11330896|NCT03471871|BG002|Baseline|Total|Total of all reporting groups
11330897|NCT03471871|FG000|Participant Flow|HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg|Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (milligram) (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
11330898|NCT03471871|FG001|Participant Flow|HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo|Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
11330899|NCT03471871|FG002|Participant Flow|HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg|Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
11330900|NCT03471871|FG003|Participant Flow|OSA Cohort, Sequence D: Placebo, Lemborexant 10mg|Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
11330901|NCT03471871|FG004|Participant Flow|OSA Cohort, Sequence E: Lemborexant 10mg, Placebo|Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once in the evening of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo, tablet, orally, once, in the evening of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
11330902|NCT03471871|OG000|Outcome|HV Cohort: Placebo|Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330903|NCT03471871|OG001|Outcome|HV Cohort: Lemborexant 10 mg|Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330904|NCT03471871|OG002|Outcome|HV Cohort: Lemborexant 25 mg|Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330905|NCT03471871|OG000|Outcome|OSA Cohort: Placebo|Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
11330906|NCT03471871|OG001|Outcome|OSA Cohort: Lemborexant 10 mg|Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
11330907|NCT03471871|EG000|Reported Event|HV Cohort: Placebo|Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330908|NCT03471871|EG001|Reported Event|HV Cohort: Lemborexant 10 mg|Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets [to maintain blind]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330909|NCT03471871|EG002|Reported Event|HV Cohort: Lemborexant 25 mg|Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
11330910|NCT03471871|EG003|Reported Event|OSA Cohort: Placebo|Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
11330911|NCT03471871|EG004|Reported Event|OSA Cohort: Lemborexant 10 mg|Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
11330912|NCT03471975|BG000|Baseline|Direct Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor.~direct laryngoscope: the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen."
11330913|NCT03471975|BG001|Baseline|Video Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope using video function.~Trainer and Trainee both see the monitor.~video laryngoscope: the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen."
11330914|NCT03471975|BG002|Baseline|Total|Total of all reporting groups
11330915|NCT03471975|FG000|Participant Flow|Direct Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor.~direct laryngoscope: the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen."
11330916|NCT03471975|FG001|Participant Flow|Video Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope using video function.~Trainer and Trainee both see the monitor.~video laryngoscope: the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen."
11330917|NCT03471975|OG000|Outcome|Direct Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor.~direct laryngoscope: the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen."
11330918|NCT03471975|OG001|Outcome|Video Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope using video function.~Trainer and Trainee both see the monitor.~video laryngoscope: the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen."
11330919|NCT03471975|EG000|Reported Event|Direct Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope as direct laryngoscope. Only trainer can see the monitor.~direct laryngoscope: the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen."
11330920|NCT03471975|EG001|Reported Event|Video Laryngoscope|"teaching tracheal intubation using McGrath video laryngoscope using video function.~Trainer and Trainee both see the monitor.~video laryngoscope: the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen."
11330921|NCT03472014|BG000|Baseline|MVA-BN|Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
11330922|NCT03472014|FG000|Participant Flow|MVA-BN|Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
11330923|NCT03472014|OG000|Outcome|MVA-BN|Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
11330924|NCT03472014|EG000|Reported Event|MVA-BN|Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
11330925|NCT03472287|BG000|Baseline|Cohort 1 (Adolescents, Adults)|Adolescent and adult patients with EB (aged 12 and older) received Diacerein 1% Ointment daily for 10 days.
11330926|NCT03472287|BG001|Baseline|Cohort 2 (Children)|Children with EB (aged 4 to 11 years, inclusive) received Diacerein 1% Ointment daily for 10 days.
11330927|NCT03472287|BG002|Baseline|Total|Total of all reporting groups
11330928|NCT03472287|FG000|Participant Flow|Cohort 1 (Adolescents, Adults)|Adolescent and adult subjects with EB (aged 12 and older) received diacerein 1% ointment daily for 10 days
11330929|NCT03472287|FG001|Participant Flow|Cohort 2 (Children)|Children with EB (aged 4 to 11 years, inclusive) received diacerein 1% ointment daily for 10 days
11330930|NCT03472287|OG000|Outcome|Cohort 1 (Adolescents, Adults)|Adolescent/adult subjects with EB (aged 12 years and older) received diacerein 1% ointment daily for 10 days.
11330931|NCT03472287|OG001|Outcome|Cohort 2 (Children)|Children with EB (ages 4-11 yrs, inclusive) were administered diacerein 1% ointment topically for 10 days.
11330932|NCT03472287|EG000|Reported Event|Cohort 1 (Adolescents, Adults)|Adolescent/adult patients with EB (aged 12 and older) received Diacerein 1% Ointment daily for 10 days
11330933|NCT03472287|EG001|Reported Event|Cohort 2 (Children)|Children with EB (aged 4 to 11 years, inclusive) received Diacerein 1% Ointment daily for 10 days
11330934|NCT03472326|BG000|Baseline|Sentinel Cohort 1: GS-9131 60 mg|Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1.
11330935|NCT03472326|BG001|Baseline|Sentinel Cohort 2: GS-9131 180 mg|Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
11330936|NCT03472326|BG002|Baseline|Total|Total of all reporting groups
11330937|NCT03472326|FG000|Participant Flow|Part 1 Sentinel Cohort 1: GS-9131 60 mg|Participants received GS-9131 60 mg tablets orally once daily in addition to their current failing antiretroviral (ARV) regimen for a period of 10 days.
11330938|NCT03472326|FG001|Participant Flow|Part 1 Sentinel Cohort 2: GS-9131 180 mg|Participants received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days.
11330939|NCT03472326|FG002|Participant Flow|Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV|Participants who completed dosing in Sentinel Cohort 1 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 60 mg tablets + bictegravir (BIC) 30 mg tablets + darunavir (DRV) 800 mg tablets + ritonavir (RTV) 100 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 60 mg tablets + BIC 75 mg tablets + tenofovir alafenamide (TAF) 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
11335767|NCT03556579|FG001|Participant Flow|OD:Test, OS:Control/ OD:Control, OS:Test|Subjects that were randomized to receive at visit 1 the Test lens in their right eye and the Control lens in their left eye and at visit 2 was randomized to receive the Control lens in their right eye and the Test lens in their left eye.
11330940|NCT03472326|FG003|Participant Flow|Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF|Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
11330941|NCT03472326|OG000|Outcome|Part 1: Randomized Cohort|Participants were randomized in 1:1:1:1 so as to receive GS-9131 tablets orally once daily in 3 active dose levels up to a maximum of 180 mg or Placebo to match GS-9131 tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
11330942|NCT03472326|OG000|Outcome|Sentinel Cohort 1: GS-9131 60 mg|Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1.
11330943|NCT03472326|OG000|Outcome|Sentinel Cohort 2: GS-9131 180 mg|Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
11330944|NCT03472326|OG000|Outcome|Part 2: GS-9131 + BIC + DRV + RTV|Participants who completed dosing in Sentinel Cohort 1 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 60 mg tablets + BIC 30 mg tablets + DRV 800 mg tablets + RTV 100 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 60 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
11330945|NCT03472326|OG001|Outcome|Part 2: GS-9131 + BIC + TAF|Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA > 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
11330946|NCT03472326|EG000|Reported Event|Part 1 Setinel Cohort 1: GS-9131 60 mg|Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1.
11330947|NCT03472326|EG001|Reported Event|Part 1 Sentinel Cohort 2: GS-9131 180 mg|Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
11330948|NCT03472469|BG000|Baseline|Original MMPR - Descending Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.
11330949|NCT03472469|BG001|Baseline|MAST MMPR - Escalating Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.
11330950|NCT03472469|BG002|Baseline|Total|Total of all reporting groups
11330951|NCT03472469|FG000|Participant Flow|Original MMPR - Descending Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.
11330952|NCT03472469|FG001|Participant Flow|MAST MMPR - Escalating Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.
11330953|NCT03472469|OG000|Outcome|Original MMPR - Descending Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.
11330954|NCT03472469|OG001|Outcome|MAST MMPR - Escalating Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.
11330955|NCT03472469|EG000|Reported Event|Original MMPR - Descending Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.
11330956|NCT03472469|EG001|Reported Event|MAST MMPR - Escalating Dose Arm|Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.
11330957|NCT03472534|BG000|Baseline|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
11330958|NCT03472534|FG000|Participant Flow|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
11330959|NCT03472534|OG000|Outcome|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
11330960|NCT03472534|EG000|Reported Event|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.
11330961|NCT03472547|BG000|Baseline|Single Cohort (Healthy Volunteers)|All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
11330962|NCT03472547|FG000|Participant Flow|Single Cohort (Healthy Volunteers)|All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
11330963|NCT03472547|OG000|Outcome|Observed Sensitization|All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
11330964|NCT03472547|EG000|Reported Event|Single Cohort (Healthy Volunteers)|All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
11330965|NCT03473171|BG000|Baseline|Nasal Non-invasive Ventilation With RAM Cannula|Nasal non-invasive ventilation with RAM cannula: Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
11330966|NCT03473171|FG000|Participant Flow|Nasal Non-invasive Ventilation With RAM Cannula|Nasal non-invasive ventilation with RAM cannula: Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
11330967|NCT03473171|OG000|Outcome|Nasal Non-invasive Ventilation With RAM Cannula|Nasal non-invasive ventilation with RAM cannula: Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
11330968|NCT03473171|EG000|Reported Event|Nasal Non-invasive Ventilation With RAM Cannula|Nasal non-invasive ventilation with RAM cannula: Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
11335768|NCT03556579|FG002|Participant Flow|OD:Control, OS:Test/ OD:Test, OS:Control|Subjects that were randomized to receive at visit 1 the Control lens in their right eye and the Test lens in their left eye and at visit 2 was randomized to receive the Test lens in their right eye and the Control lens in their left eye.
11330969|NCT03473184|BG000|Baseline|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
11330970|NCT03473184|FG000|Participant Flow|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
11330971|NCT03473184|OG000|Outcome|Single Cohort (Healthy Volunteer)|Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
11330972|NCT03473184|EG000|Reported Event|Single Cohort (Healthy Volunteers)|Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
11330973|NCT03473197|BG000|Baseline|Single Cohort (Healthy Volunteers)|During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
11330974|NCT03473197|FG000|Participant Flow|Single Cohort (Healthy Volunteers)|During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
11330975|NCT03473197|OG000|Outcome|Single Cohort (Healthy Volunteers)|During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
11330976|NCT03473197|EG000|Reported Event|Single Cohort (Healthy Volunteers)|During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
11330977|NCT03473236|BG000|Baseline|SAD GB002 Placebo QD|A placebo SAD inhaled QD over 11 days in healthy volunteers
11330978|NCT03473236|BG001|Baseline|SAD GB002 3.75 mg QD|GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
11330979|NCT03473236|BG002|Baseline|SAD GB002 7.5 mg QD|GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
11330980|NCT03473236|BG003|Baseline|SAD GB002 15 mg QD|GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
11330981|NCT03473236|BG004|Baseline|SAD GB002 30 mg QD|GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
11330982|NCT03473236|BG005|Baseline|SAD GB002 48 mg QD|GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
11330983|NCT03473236|BG006|Baseline|MAD GB002 Placebo BID/TID|A placebo MAD inhaled either BID or TID over 35 days in healthy volunteers
11330984|NCT03473236|BG007|Baseline|MAD GB002 18 mg BID|GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
11330985|NCT03473236|BG008|Baseline|MAD GB002 24 mg TID|GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
11330986|NCT03473236|BG009|Baseline|MAD GB002 48 mg TID|GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
11330987|NCT03473236|BG010|Baseline|Total|Total of all reporting groups
11330988|NCT03473236|FG000|Participant Flow|SAD PK10571 (GB002) Placebo QD|A placebo single ascending dose (SAD) inhaled once a day (QD) over 11 days in healthy volunteers
11330989|NCT03473236|FG001|Participant Flow|SAD GB002 3.75 mg QD|GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
11330990|NCT03473236|FG002|Participant Flow|SAD GB002 7.5 mg QD|GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
11330991|NCT03473236|FG003|Participant Flow|SAD GB002 15 mg QD|GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
11330992|NCT03473236|FG004|Participant Flow|SAD GB002 30 mg QD|GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
10841034|NCT00234832|OG006|Outcome|CV + DM Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
11330993|NCT03473236|FG005|Participant Flow|SAD GB002 48 mg QD|GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
11330994|NCT03473236|FG006|Participant Flow|MAD GB002 Placebo BID/TID|A placebo multiple ascending dose (MAD) inhaled either twice daily (BID) or thrice daily (TID) over 35 days in healthy volunteers
11330995|NCT03473236|FG007|Participant Flow|MAD GB002 18 mg BID|GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
11330996|NCT03473236|FG008|Participant Flow|MAD GB002 24 mg TID|GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
11330997|NCT03473236|FG009|Participant Flow|MAD GB002 48 mg TID|GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
11330998|NCT03473236|OG000|Outcome|SAD GB002 Placebo QD|A placebo SAD inhaled QD over 11 days in healthy volunteers
11330999|NCT03473236|OG001|Outcome|SAD GB002 3.75 mg QD|GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
11331000|NCT03473236|OG002|Outcome|SAD GB002 7.5 mg QD|GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
11331001|NCT03473236|OG003|Outcome|SAD GB002 15 mg QD|GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
11331002|NCT03473236|OG004|Outcome|SAD GB002 30 mg QD|GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
11331003|NCT03473236|OG005|Outcome|SAD GB002 48 mg QD|GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
11331004|NCT03473236|OG006|Outcome|MAD GB002 Placebo BID/TID|A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
11331005|NCT03473236|OG007|Outcome|MAD GB002 18 mg BID|GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
11331006|NCT03473236|OG008|Outcome|MAD GB002 24 mg TID|GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
11331007|NCT03473236|OG009|Outcome|MAD GB002 48 mg TID|GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
11331008|NCT03473236|OG000|Outcome|SAD GB002 3.75 mg QD|GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
11331009|NCT03473236|OG001|Outcome|SAD GB002 7.5 mg QD|GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
11331010|NCT03473236|OG002|Outcome|SAD GB002 15 mg QD|GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
11331011|NCT03473236|OG003|Outcome|SAD GB002 30 mg QD|GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
11331012|NCT03473236|OG004|Outcome|SAD GB002 48 mg QD|GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
11331013|NCT03473236|OG000|Outcome|MAD GB002 18 mg BID|GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
11331014|NCT03473236|OG001|Outcome|MAD GB002 24 mg TID|GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
11331015|NCT03473236|OG002|Outcome|MAD GB002 48 mg TID|GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
11331016|NCT03473236|EG000|Reported Event|SAD GB002 Placebo QD|A placebo single ascending dose (SAD) inhaled once a day (QD) over 11 days in healthy volunteers
11331017|NCT03473236|EG001|Reported Event|SAD GB002 3.75 mg QD|GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
11331018|NCT03473236|EG002|Reported Event|SAD GB002 7.5 mg QD|GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
11331019|NCT03473236|EG003|Reported Event|SAD GB002 15 mg QD|GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
11331020|NCT03473236|EG004|Reported Event|SAD GB002 30 mg QD|GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
11331021|NCT03473236|EG005|Reported Event|SAD GB002 48 mg QD|GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
11331022|NCT03473236|EG006|Reported Event|MAD GB002 Placebo BID/TID|A placebo multiple ascending dose (MAD) inhaled either twice daily (BID) or thrice daily (TID) to match the dosing in the MAD arms over 35 days in healthy volunteers
11331023|NCT03473236|EG007|Reported Event|MAD GB002 18 mg BID|GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
11331024|NCT03473236|EG008|Reported Event|MAD GB002 24 mg TID|GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
11331025|NCT03473236|EG009|Reported Event|MAD GB002 48 mg TID|GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
11331026|NCT03473301|BG000|Baseline|Allogeneic Umbilical Cord Blood (AlloCB)|"Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331027|NCT03473301|BG001|Baseline|Cord Tissue Mesenchymal Stromal Cells (MSC)|"Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors~Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months)."
11331028|NCT03473301|BG002|Baseline|Natural History, Then AlloCB|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331029|NCT03473301|BG003|Baseline|Total|Total of all reporting groups
11331030|NCT03473301|FG000|Participant Flow|Allogeneic Umbilical Cord Blood (AlloCB)|"Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331031|NCT03473301|FG001|Participant Flow|Cord Tissue Mesenchymal Stromal Cells (MSC)|"Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors~Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months)."
11331032|NCT03473301|FG002|Participant Flow|Natural History, Then AlloCB|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331033|NCT03473301|OG000|Outcome|Allogeneic Umbilical Cord Blood (AlloCB)|"Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11335769|NCT03556579|FG003|Participant Flow|OD:Control, OS:Test/ OD:Control, OS:Test|Subjects that were randomized to receive the Control lens in their right eye and the Test lens in their left eye at both visit 1 and visit 2.
10841035|NCT00234832|OG007|Outcome|CV + DM Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
10841036|NCT00234832|EG000|Reported Event|Lead-in Period Sibutramine|Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
10841037|NCT00234832|EG001|Reported Event|Randomized Sibutramine|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
10841038|NCT00234832|EG002|Reported Event|Randomized Placebo|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
10841039|NCT00234884|BG000|Baseline|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
10841040|NCT00234884|FG000|Participant Flow|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
10841041|NCT00234884|OG000|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
10841042|NCT00234884|EG000|Reported Event|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
10841043|NCT00235391|BG000|Baseline|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841044|NCT00235391|BG001|Baseline|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841045|NCT00235391|BG002|Baseline|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841046|NCT00235391|BG003|Baseline|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841047|NCT00235391|BG004|Baseline|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841048|NCT00235391|BG005|Baseline|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841049|NCT00235391|BG006|Baseline|Total|Total of all reporting groups
10841050|NCT00235391|FG000|Participant Flow|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841051|NCT00235391|FG001|Participant Flow|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841052|NCT00235391|FG002|Participant Flow|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841053|NCT00235391|FG003|Participant Flow|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841054|NCT00235391|FG004|Participant Flow|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841055|NCT00235391|FG005|Participant Flow|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841056|NCT00235391|OG000|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841057|NCT00235391|OG001|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841058|NCT00235391|OG002|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841059|NCT00235391|OG003|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841060|NCT00235391|OG004|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841061|NCT00235391|OG005|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841062|NCT00235391|EG000|Reported Event|All Participants|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
10841063|NCT00235443|BG000|Baseline|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841064|NCT00235443|BG001|Baseline|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841065|NCT00235443|BG002|Baseline|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841066|NCT00235443|BG003|Baseline|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841067|NCT00235443|BG004|Baseline|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841068|NCT00235443|BG005|Baseline|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841069|NCT00235443|BG006|Baseline|Total|Total of all reporting groups
10841070|NCT00235443|FG000|Participant Flow|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841071|NCT00235443|FG001|Participant Flow|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841072|NCT00235443|FG002|Participant Flow|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841073|NCT00235443|FG003|Participant Flow|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841074|NCT00235443|FG004|Participant Flow|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841075|NCT00235443|FG005|Participant Flow|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841076|NCT00235443|OG000|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841077|NCT00235443|OG001|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841078|NCT00235443|OG002|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841079|NCT00235443|OG003|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841080|NCT00235443|OG004|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841081|NCT00235443|OG005|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841082|NCT00235443|OG006|Outcome|Total|All modal dose groups combined
10841083|NCT00235443|EG000|Reported Event|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841084|NCT00235443|EG001|Reported Event|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841085|NCT00235443|EG002|Reported Event|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841086|NCT00235443|EG003|Reported Event|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841087|NCT00235443|EG004|Reported Event|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841088|NCT00235443|EG005|Reported Event|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
10841089|NCT00235443|EG006|Reported Event|Total|All modal dose groups combined
10841090|NCT00235456|BG000|Baseline|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841091|NCT00235456|BG001|Baseline|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841092|NCT00235456|BG002|Baseline|Total|Total of all reporting groups
10841093|NCT00235456|FG000|Participant Flow|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841094|NCT00235456|FG001|Participant Flow|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841095|NCT00235456|OG000|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841096|NCT00235456|OG001|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
11335770|NCT03556579|OG000|Outcome|Testing With Additional Light Source|Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
10841097|NCT00235456|EG000|Reported Event|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10841098|NCT00235456|EG001|Reported Event|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
10842951|NCT00250705|FG000|Participant Flow|Aripiprazole Treatment of Conduct Disorde|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
10842952|NCT00250705|OG000|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 10 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
10842953|NCT00250705|OG000|Outcome|Adolescent Conduct Disorder Males|"All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.~Aripiprazole: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day."
10842954|NCT00250705|OG000|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
10842955|NCT00250705|EG000|Reported Event|Aripiprazole in the Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
10842956|NCT00250835|BG000|Baseline|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
10842957|NCT00250835|FG000|Participant Flow|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
10842958|NCT00250835|OG000|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
10842959|NCT00250835|EG000|Reported Event|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
10842960|NCT00250926|BG000|Baseline|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
10842961|NCT00250926|FG000|Participant Flow|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
10842962|NCT00250926|OG000|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
10841099|NCT00235495|BG000|Baseline|Albumin|Treatment with 25% Albumin, 2.0 g/kg
10841100|NCT00235495|BG001|Baseline|Saline|Treatment with same volume of normal saline
10841101|NCT00235495|BG002|Baseline|Total|Total of all reporting groups
10841102|NCT00235495|FG000|Participant Flow|Albumin|Treatment with 25% Albumin, 2.0 g/kg
10841103|NCT00235495|FG001|Participant Flow|Saline|Treatment with same volume of normal saline
10841104|NCT00235495|OG000|Outcome|Albumin|Treatment with 25% Albumin, 2.0 g/kg
10841105|NCT00235495|OG001|Outcome|Saline|Treatment with same volume of normal saline
10841106|NCT00235495|EG000|Reported Event|Albumin|Treatment with 25% Albumin, 2.0 g/kg
10841107|NCT00235495|EG001|Reported Event|Saline|Treatment with same volume of normal saline
10841108|NCT00235547|BG000|Baseline|Contraception-Immediate Start|"contraception after abortion and before leaving the clinic, observed by clinic staff~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841109|NCT00235547|BG001|Baseline|Contraception-Delayed Start|"instructed to begin contraception the first Sunday after leaving the clinic~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841110|NCT00235547|BG002|Baseline|Total|Total of all reporting groups
10841111|NCT00235547|FG000|Participant Flow|Contraception-Immediate Start|"contraception after abortion and before leaving the clinic, observed by clinic staff~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841112|NCT00235547|FG001|Participant Flow|Contraception-Delayed Start|"instructed to begin contraception the first Sunday after leaving the clinic~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841113|NCT00235547|OG000|Outcome|Contraception-Immediate Start|"contraception after abortion and before leaving the clinic, observed by clinic staff~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841114|NCT00235547|OG001|Outcome|Contraception-Delayed Start|"instructed to begin contraception the first Sunday after leaving the clinic~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841115|NCT00235547|EG000|Reported Event|Contraception-Immediate Start|"contraception after abortion and before leaving the clinic, observed by clinic staff~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841116|NCT00235547|EG001|Reported Event|Contraception-Delayed Start|"instructed to begin contraception the first Sunday after leaving the clinic~timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic"
10841117|NCT00235573|BG000|Baseline|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
11331034|NCT03473301|OG001|Outcome|Cord Tissue Mesenchymal Stromal Cells (MSC)|"Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors~Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months)."
10841118|NCT00235573|FG000|Participant Flow|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
10841119|NCT00235573|OG000|Outcome|Vitamin B12 Group|All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
10841120|NCT00235573|EG000|Reported Event|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
10841121|NCT00235716|BG000|Baseline|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
10841122|NCT00235716|BG001|Baseline|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
10841123|NCT00235716|BG002|Baseline|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
10841124|NCT00235716|BG003|Baseline|Placebo|Matching placebo pills for vitamin E and memantine
10841125|NCT00235716|BG004|Baseline|Total|Total of all reporting groups
10841126|NCT00235716|FG000|Participant Flow|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
10841127|NCT00235716|FG001|Participant Flow|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
10841128|NCT00235716|FG002|Participant Flow|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
10841129|NCT00235716|FG003|Participant Flow|Placebo|Matching placebo pills for vitamin E and memantine
11335771|NCT03556579|OG001|Outcome|Control With Additional Source|Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
10841130|NCT00235716|OG000|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
10841131|NCT00235716|OG001|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
10841132|NCT00235716|OG002|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
10841133|NCT00235716|OG003|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
10841134|NCT00235716|EG000|Reported Event|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
10841135|NCT00235716|EG001|Reported Event|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
10841136|NCT00235716|EG002|Reported Event|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
10841137|NCT00235716|EG003|Reported Event|Placebo|Matching placebo pills for vitamin E and memantine
10841138|NCT00235755|BG000|Baseline|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
10841139|NCT00235755|BG001|Baseline|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
10841140|NCT00235755|BG002|Baseline|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
10841141|NCT00235755|BG003|Baseline|Total|Total of all reporting groups
10841142|NCT00235755|FG000|Participant Flow|Placebo|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
10841143|NCT00235755|FG001|Participant Flow|Retigabine 200 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
10841144|NCT00235755|FG002|Participant Flow|Retigabine 300 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.
10841145|NCT00235755|OG000|Outcome|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
10841146|NCT00235755|OG001|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
10841147|NCT00235755|OG002|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
10841148|NCT00235755|OG000|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12 week Maintenance Phase
10841149|NCT00235755|OG002|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
10841150|NCT00235755|OG000|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
10841151|NCT00235755|OG001|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
10841152|NCT00235755|OG002|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
11335772|NCT03556579|OG002|Outcome|Test Without Additional Light Source|Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
10841153|NCT00235755|OG002|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
10841154|NCT00235755|OG003|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
10841155|NCT00235755|OG004|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
10841156|NCT00235755|OG005|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
10841157|NCT00235755|OG000|Outcome|Placebo: Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase
10841158|NCT00235755|OG001|Outcome|Retigabine 200 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase
10841159|NCT00235755|OG002|Outcome|Retigabine 300 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase
10841160|NCT00235755|EG000|Reported Event|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
10841161|NCT00235755|EG001|Reported Event|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
10841162|NCT00235755|EG002|Reported Event|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
10841163|NCT00235755|EG003|Reported Event|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
10841164|NCT00235755|EG004|Reported Event|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
10841165|NCT00235755|EG005|Reported Event|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
10841166|NCT00235833|BG000|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
10841167|NCT00235833|FG000|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
10841168|NCT00235833|OG000|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
10841169|NCT00235833|EG000|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
10841170|NCT00235872|BG000|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
10841171|NCT00235872|FG000|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
10841172|NCT00235872|OG000|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
10841173|NCT00235872|EG000|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
10841174|NCT00235989|BG000|Baseline|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
10841175|NCT00235989|BG001|Baseline|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
10841176|NCT00235989|BG002|Baseline|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
10841177|NCT00235989|BG003|Baseline|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
10841178|NCT00235989|BG004|Baseline|Total|Total of all reporting groups
10841179|NCT00235989|FG000|Participant Flow|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
10841180|NCT00235989|FG001|Participant Flow|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
10841181|NCT00235989|FG002|Participant Flow|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
10841182|NCT00235989|FG003|Participant Flow|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
10841183|NCT00235989|FG004|Participant Flow|CT: IFNB-1b 250mcg|Core Treatment 250 mcg
10841184|NCT00235989|FG005|Participant Flow|CT: IFNB-1b 500mcg|Core Treatment 500 mcg
10841185|NCT00235989|OG000|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
10841186|NCT00235989|OG001|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
10841187|NCT00235989|OG002|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
10841188|NCT00235989|OG003|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
10841189|NCT00235989|EG000|Reported Event|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
10841190|NCT00235989|EG001|Reported Event|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
10841191|NCT00235989|EG002|Reported Event|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
10841192|NCT00235989|EG003|Reported Event|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
10841193|NCT00236080|BG000|Baseline|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
10841194|NCT00236080|BG001|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
10841195|NCT00236080|BG002|Baseline|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
10841196|NCT00236080|BG003|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
10841197|NCT00236080|BG004|Baseline|Placebo|Matching placebo tablets once daily only on nights worked
10841198|NCT00236080|BG005|Baseline|Total|Total of all reporting groups
10841199|NCT00236080|FG000|Participant Flow|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
10841200|NCT00236080|FG001|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
10841201|NCT00236080|FG002|Participant Flow|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
10841202|NCT00236080|FG003|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
10841203|NCT00236080|FG004|Participant Flow|Placebo|Matching placebo tablets once daily only on nights worked
10841204|NCT00236080|OG000|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
10841205|NCT00236080|OG001|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
10841206|NCT00236080|OG002|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
10841207|NCT00236080|OG003|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
10841208|NCT00236080|OG004|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
10841209|NCT00236080|EG000|Reported Event|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
10841210|NCT00236080|EG001|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
10841211|NCT00236080|EG002|Reported Event|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
10841212|NCT00236080|EG003|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
10841213|NCT00236080|EG004|Reported Event|Placebo|Matching placebo tablets once daily only on nights worked
10841214|NCT00236184|BG000|Baseline|Placebo|oral placebo tablet
10841215|NCT00236184|BG001|Baseline|Rabeprazole 10 mg|oral enteric-coated tablet
10841216|NCT00236184|BG002|Baseline|Total|Total of all reporting groups
10841217|NCT00236184|FG000|Participant Flow|Placebo|
10841218|NCT00236184|FG001|Participant Flow|Rabeprazole 10 mg|
10841219|NCT00236184|OG000|Outcome|Placebo|
10841220|NCT00236184|OG001|Outcome|Rabeprazole 10 mg|
10841221|NCT00236184|EG000|Reported Event|Placebo|
10841222|NCT00236184|EG001|Reported Event|Rabeprazole 10 mg|
10841223|NCT00236197|BG000|Baseline|Placebo|
10841224|NCT00236197|BG001|Baseline|Rabeprazole 10 mg|
10841225|NCT00236197|BG002|Baseline|Total|Total of all reporting groups
10841226|NCT00236197|FG000|Participant Flow|Placebo|
10841227|NCT00236197|FG001|Participant Flow|Rabeprazole 10 mg|
10841228|NCT00236197|OG000|Outcome|Placebo|
10841229|NCT00236197|OG001|Outcome|Rabeprazole 10 mg|
10841230|NCT00236197|EG000|Reported Event|Placebo|
10841231|NCT00236197|EG001|Reported Event|Rabeprazole 10 mg|
10841232|NCT00236899|BG000|Baseline|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841233|NCT00236899|BG001|Baseline|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841234|NCT00236899|BG002|Baseline|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841235|NCT00236899|BG003|Baseline|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841236|NCT00236899|BG004|Baseline|Total|Total of all reporting groups
10841237|NCT00236899|FG000|Participant Flow|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841238|NCT00236899|FG001|Participant Flow|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841239|NCT00236899|FG002|Participant Flow|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841240|NCT00236899|FG003|Participant Flow|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841241|NCT00236899|OG000|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841242|NCT00236899|OG001|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841243|NCT00236899|OG000|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841244|NCT00236899|OG001|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
10841245|NCT00236899|OG000|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841246|NCT00236899|OG001|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841247|NCT00236899|OG002|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841248|NCT00236899|OG003|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
11335773|NCT03556579|OG003|Outcome|Control Without Additional Light Source|Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
10841249|NCT00236899|OG000|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841250|NCT00236899|OG001|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841251|NCT00236899|OG002|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841252|NCT00236899|EG000|Reported Event|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841253|NCT00236899|EG001|Reported Event|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841254|NCT00236899|EG002|Reported Event|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841255|NCT00236899|EG003|Reported Event|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
10841256|NCT00236938|BG000|Baseline|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
10841257|NCT00236938|BG001|Baseline|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
10841258|NCT00236938|BG002|Baseline|Total|Total of all reporting groups
10841259|NCT00236938|FG000|Participant Flow|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
10841260|NCT00236938|FG001|Participant Flow|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
10841261|NCT00236938|OG000|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
10841262|NCT00236938|OG001|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
10841263|NCT00236938|EG000|Reported Event|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
10841264|NCT00236938|EG001|Reported Event|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
10841265|NCT00236951|BG000|Baseline|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841266|NCT00236951|BG001|Baseline|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
10841267|NCT00236951|BG002|Baseline|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841268|NCT00236951|BG003|Baseline|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
10841269|NCT00236951|BG004|Baseline|Total|Total of all reporting groups
10841270|NCT00236951|FG000|Participant Flow|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
11335774|NCT03556579|OG000|Outcome|Test Without Additional Light Source|Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
10841271|NCT00236951|FG001|Participant Flow|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
10841272|NCT00236951|FG002|Participant Flow|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841273|NCT00236951|FG003|Participant Flow|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
10841274|NCT00236951|OG000|Outcome|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841275|NCT00236951|OG001|Outcome|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
10841276|NCT00236951|OG002|Outcome|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841277|NCT00236951|OG003|Outcome|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
10841278|NCT00236951|EG000|Reported Event|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841279|NCT00236951|EG001|Reported Event|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
10841280|NCT00236951|EG002|Reported Event|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
10841281|NCT00236951|EG003|Reported Event|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
10841282|NCT00236977|BG000|Baseline|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
10841283|NCT00236977|BG001|Baseline|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
10841284|NCT00236977|BG002|Baseline|Total|Total of all reporting groups
10841285|NCT00236977|FG000|Participant Flow|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
10841286|NCT00236977|FG001|Participant Flow|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
10841287|NCT00236977|OG000|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
10841288|NCT00236977|OG001|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
10841289|NCT00236977|EG000|Reported Event|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
10841290|NCT00236977|EG001|Reported Event|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
10841291|NCT00237042|BG000|Baseline|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
10841292|NCT00237042|BG001|Baseline|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
10841293|NCT00237042|BG002|Baseline|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
10841294|NCT00237042|BG003|Baseline|Total|Total of all reporting groups
10848204|NCT00289120|FG000|Participant Flow|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks wash-out period before patients entere phase 2 of thre study.~Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
10848205|NCT00289120|OG000|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
10848206|NCT00289120|OG001|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
10848207|NCT00289120|OG000|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
10848208|NCT00289120|OG001|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
10841295|NCT00237042|FG000|Participant Flow|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
10841296|NCT00237042|FG001|Participant Flow|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
10841297|NCT00237042|FG002|Participant Flow|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
10841298|NCT00237042|OG000|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
10841299|NCT00237042|OG001|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
10841300|NCT00237042|OG002|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
10841301|NCT00237042|EG000|Reported Event|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
10841302|NCT00237042|EG001|Reported Event|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
10841303|NCT00237042|EG002|Reported Event|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
10841304|NCT00237185|BG000|Baseline|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
10841305|NCT00237185|BG001|Baseline|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
10841306|NCT00237185|BG002|Baseline|Total|Total of all reporting groups
10841307|NCT00237185|FG000|Participant Flow|Imatinib Mesylate 400 mg|imatinib mesylate 400 mg once daily
10841308|NCT00237185|FG001|Participant Flow|Imatinib Mesylate 600 mg|imatinib mesylate 600 mg once daily
10841309|NCT00237185|OG000|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
10841310|NCT00237185|OG001|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
10841311|NCT00237185|EG000|Reported Event|Imatinib Mesylate 400 mg|400 mg
10841312|NCT00237185|EG001|Reported Event|Imatinib Mesylate 600 mg|600 mg
10841313|NCT00237458|BG000|Baseline|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
10841314|NCT00237458|FG000|Participant Flow|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
10841315|NCT00237458|OG000|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
10841316|NCT00237458|EG000|Reported Event|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
10841317|NCT00237666|BG000|Baseline|Ziprasidone|
10841318|NCT00237666|FG000|Participant Flow|Ziprasidone|Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
10841319|NCT00237666|OG000|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
10841320|NCT00237666|EG000|Reported Event|Ziprasidone|
10841321|NCT00237692|BG000|Baseline|Arm 1- Control|A group of hypertensive patients who receive usual care
10841322|NCT00237692|BG001|Baseline|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
10841323|NCT00237692|BG002|Baseline|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
10841324|NCT00237692|BG003|Baseline|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
10841325|NCT00237692|BG004|Baseline|Total|Total of all reporting groups
10841326|NCT00237692|FG000|Participant Flow|Arm 1- Control|A group of hypertensive patients who receive usual care
10841327|NCT00237692|FG001|Participant Flow|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
10841328|NCT00237692|FG002|Participant Flow|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
10841329|NCT00237692|FG003|Participant Flow|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
10841330|NCT00237692|OG000|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
10841331|NCT00237692|OG001|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
10841332|NCT00237692|OG002|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
10841333|NCT00237692|OG003|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
10841334|NCT00237692|EG000|Reported Event|Arm 1- Control|A group of hypertensive patients who receive usual care
10841335|NCT00237692|EG001|Reported Event|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
10841336|NCT00237692|EG002|Reported Event|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
10841337|NCT00237692|EG003|Reported Event|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
10841338|NCT00237718|BG000|Baseline|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
10841339|NCT00237718|BG001|Baseline|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
10841340|NCT00237718|BG002|Baseline|Total|Total of all reporting groups
10841341|NCT00237718|FG000|Participant Flow|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
10841342|NCT00237718|FG001|Participant Flow|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
10841343|NCT00237718|OG000|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
10841344|NCT00237718|OG001|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
10841345|NCT00237718|EG000|Reported Event|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
10841346|NCT00237718|EG001|Reported Event|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
10841347|NCT00237744|BG000|Baseline|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
10841348|NCT00237744|BG001|Baseline|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow
10841349|NCT00237744|BG002|Baseline|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand
10841350|NCT00237744|BG003|Baseline|Total|Total of all reporting groups
10841351|NCT00237744|FG000|Participant Flow|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
10841352|NCT00237744|FG001|Participant Flow|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
10841353|NCT00237744|FG002|Participant Flow|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
10841354|NCT00237744|OG000|Outcome|Shoulder/Elbow Robotics+Whole Arm Motor Learning|Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
10841355|NCT00237744|OG001|Outcome|Wrist/Hand FES+Whole Arm Motor Learning|The intervention provided in this group included surface FES and whole are motor learning.
10841356|NCT00237744|OG002|Outcome|Whole Arm Motor Learning Group|Interventions included whole arm motor learning, FES and Robotics.
10841357|NCT00237744|OG000|Outcome|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
10841358|NCT00237744|OG001|Outcome|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
10841359|NCT00237744|OG002|Outcome|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
10841360|NCT00237744|EG000|Reported Event|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)
10841361|NCT00237744|EG001|Reported Event|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
10841362|NCT00237744|EG002|Reported Event|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
10841363|NCT00237770|BG000|Baseline|Individuals With Tetraplegia|Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
10841364|NCT00237770|BG001|Baseline|Able-bodied Controls|Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
10841365|NCT00237770|BG002|Baseline|Total|Total of all reporting groups
10841366|NCT00237770|FG000|Participant Flow|Tetraplegic Subjects|All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
10841367|NCT00237770|FG001|Participant Flow|Control Subjects|Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
10841368|NCT00237770|OG000|Outcome|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
10841369|NCT00237770|OG001|Outcome|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
10841370|NCT00237770|OG002|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
10841371|NCT00237770|OG003|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
10841372|NCT00237770|EG000|Reported Event|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
10841373|NCT00237770|EG001|Reported Event|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
10841374|NCT00237770|EG002|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
10841375|NCT00237770|EG003|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
10841376|NCT00237796|BG000|Baseline|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
10841377|NCT00237796|BG001|Baseline|Goal Focused Supportive Contact (GFSC)|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
10841378|NCT00237796|BG002|Baseline|Total|Total of all reporting groups
10841379|NCT00237796|FG000|Participant Flow|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
10841380|NCT00237796|FG001|Participant Flow|Goal Focused Supportive Contact (GFSC)|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
10841381|NCT00237796|OG000|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
10841382|NCT00237796|OG001|Outcome|Goal Focused Supportive Contact|"Goal Focused Supportive Contact~Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months."
10841383|NCT00237796|OG001|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
10841384|NCT00237796|EG000|Reported Event|CBSST|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
10841385|NCT00237796|EG001|Reported Event|Goal Directed Supportive Care|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
10841386|NCT00237809|BG000|Baseline|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
10841387|NCT00237809|BG001|Baseline|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
10841388|NCT00237809|BG002|Baseline|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
10841389|NCT00237809|BG003|Baseline|Placebo/Control|"Placebo/control~Cognitive retraining : Cog rehab"
10841390|NCT00237809|BG004|Baseline|Total|Total of all reporting groups
10841391|NCT00237809|FG000|Participant Flow|D-serine Drug /CRT Placebo|"D-serine/control~D-serine : D-serine (30 mg/kg)"
10841392|NCT00237809|FG001|Participant Flow|Placebo Drug /CRT|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
10841393|NCT00237809|FG002|Participant Flow|D-serine Drug/CRT|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
10841394|NCT00237809|FG003|Participant Flow|Placebo Drug/ Placebo CRT|Placebo/control
10841395|NCT00237809|OG000|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
10841396|NCT00237809|OG001|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
10841397|NCT00237809|OG002|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
10841398|NCT00237809|OG003|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
10841399|NCT00237809|EG000|Reported Event|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
10841400|NCT00237809|EG001|Reported Event|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
10841401|NCT00237809|EG002|Reported Event|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
10841402|NCT00237809|EG003|Reported Event|Placebo/Control|"Placebo/control~Cognitive retraining : video"
10841403|NCT00238108|BG000|Baseline|Melatonin|Melatonin
10841404|NCT00238108|BG001|Baseline|Placebo|Placebo
10841405|NCT00238108|BG002|Baseline|Total|Total of all reporting groups
10841406|NCT00238108|FG000|Participant Flow|Melatonin|Melatonin
10841407|NCT00238108|FG001|Participant Flow|Placebo|Placebo
10841408|NCT00238108|OG000|Outcome|Melatonin|Melatonin
10841409|NCT00238108|OG001|Outcome|Placebo|Placebo
10841410|NCT00238108|EG000|Reported Event|Melatonin|Melatonin
10841411|NCT00238108|EG001|Reported Event|Placebo|Placebo
10841412|NCT00238121|BG000|Baseline|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841413|NCT00238121|BG001|Baseline|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841414|NCT00238121|BG002|Baseline|Total|Total of all reporting groups
10841415|NCT00238121|FG000|Participant Flow|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841416|NCT00238121|FG001|Participant Flow|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841417|NCT00238121|OG000|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841418|NCT00238121|OG001|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10841419|NCT00238121|EG000|Reported Event|Sorafenib|
10841420|NCT00238238|BG000|Baseline|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
10841421|NCT00238238|BG001|Baseline|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
10841422|NCT00238238|BG002|Baseline|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
10841423|NCT00238238|BG003|Baseline|Total|Total of all reporting groups
10841424|NCT00238238|FG000|Participant Flow|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
10841425|NCT00238238|FG001|Participant Flow|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
10841426|NCT00238238|FG002|Participant Flow|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
10841427|NCT00238238|OG000|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
10841428|NCT00238238|OG001|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
10841429|NCT00238238|OG002|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
10841430|NCT00238238|EG000|Reported Event|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
10841431|NCT00238238|EG001|Reported Event|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
10841432|NCT00238238|EG002|Reported Event|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
10841433|NCT00238264|BG000|Baseline|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
10841434|NCT00238264|FG000|Participant Flow|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
10841435|NCT00238264|OG000|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
10841436|NCT00238264|EG000|Reported Event|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
10841437|NCT00238303|BG000|Baseline|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10848209|NCT00289120|EG000|Reported Event|Cola Beverage Phase|"Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks interval (wash out period) before crossover to the other treatment arm.~No adverse event reported."
10841438|NCT00238303|BG001|Baseline|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
10841439|NCT00238303|BG002|Baseline|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841440|NCT00238303|BG003|Baseline|Total|Total of all reporting groups
10841441|NCT00238303|FG000|Participant Flow|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841442|NCT00238303|FG001|Participant Flow|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
10841443|NCT00238303|FG002|Participant Flow|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841444|NCT00238303|OG000|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841445|NCT00238303|OG001|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
10841446|NCT00238303|OG002|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841447|NCT00238303|OG000|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
10841448|NCT00238303|EG000|Reported Event|Stratum 1 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
10841449|NCT00238303|EG001|Reported Event|Stratum 2 (Undergoing Surgery)|surgery : Patients undergo surgery to remove tumor
10841450|NCT00238303|EG002|Reported Event|Stratum 3 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
10841451|NCT00238355|BG000|Baseline|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
10841452|NCT00238355|FG000|Participant Flow|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
10841453|NCT00238355|OG000|Outcome|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
10841454|NCT00238355|EG000|Reported Event|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
10841455|NCT00238433|BG000|Baseline|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
10841456|NCT00238433|FG000|Participant Flow|Busulfan/Melphalan/Thiotepa|"Treatment:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days."
10841457|NCT00238433|OG000|Outcome|Busulfan/Melphalan/Thiotepa|"Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
10841458|NCT00238433|OG000|Outcome|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
10841459|NCT00238433|EG000|Reported Event|BuMelTT|"*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.~TREATMENT PLAN:~Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim"
10841460|NCT00238615|BG000|Baseline|Group 1|
10841461|NCT00238615|FG000|Participant Flow|Docetaxel / Carboplatin / XRT + Surgical Resection|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
10841462|NCT00238615|OG000|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|"All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.~Results were published PMID 21774104"
10841463|NCT00238615|OG000|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|This planned analysis of gene expression patterns was not performed.
10841464|NCT00238615|OG000|Outcome|Docetaxel+Carboplatin +Radiation+Surgery|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.
10841465|NCT00238615|EG000|Reported Event|Docetaxel / Carboplatin / XRT + Surgical Resection|Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
10841466|NCT00239005|BG000|Baseline|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
10841467|NCT00239005|BG001|Baseline|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
10841468|NCT00239005|BG002|Baseline|Total|Total of all reporting groups
10841469|NCT00239005|FG000|Participant Flow|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
10841470|NCT00239005|FG001|Participant Flow|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
10841471|NCT00239005|OG000|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
10841472|NCT00239005|OG001|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
10841473|NCT00239005|EG000|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
10841474|NCT00239005|EG001|Reported Event|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
10841475|NCT00239226|BG000|Baseline|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
10841476|NCT00239226|BG001|Baseline|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
10841477|NCT00239226|BG002|Baseline|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
10841478|NCT00239226|BG003|Baseline|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
10841479|NCT00239226|BG004|Baseline|Total|Total of all reporting groups
10841480|NCT00239226|FG000|Participant Flow|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
10841481|NCT00239226|FG001|Participant Flow|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
10841482|NCT00239226|FG002|Participant Flow|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
10841483|NCT00239226|FG003|Participant Flow|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
10841484|NCT00239226|OG000|Outcome|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
10841485|NCT00239226|OG001|Outcome|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
10841486|NCT00239226|OG002|Outcome|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
10841487|NCT00239226|OG003|Outcome|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
10841488|NCT00239226|EG000|Reported Event|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
10841489|NCT00239226|EG001|Reported Event|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
10841490|NCT00239226|EG002|Reported Event|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
10841491|NCT00239226|EG003|Reported Event|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
10841492|NCT00239356|BG000|Baseline|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841493|NCT00239356|BG001|Baseline|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841494|NCT00239356|BG002|Baseline|Total|Total of all reporting groups
10841495|NCT00239356|FG000|Participant Flow|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841496|NCT00239356|FG001|Participant Flow|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841497|NCT00239356|OG000|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841498|NCT00239356|OG001|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841499|NCT00239356|EG000|Reported Event|Bipolar I Disorder 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841500|NCT00239356|EG001|Reported Event|Schizophrenia 10 - 30 mg QD|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
10841501|NCT00239577|BG000|Baseline|Dengue Formulation 17a Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841502|NCT00239577|BG001|Baseline|Dengue Formulation 17b Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
10841503|NCT00239577|BG002|Baseline|Dengue Formulation 19 Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
10841504|NCT00239577|BG003|Baseline|Placebo Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841505|NCT00239577|BG004|Baseline|Total|Total of all reporting groups
10841506|NCT00239577|FG000|Participant Flow|Dengue Formulation 17a Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841507|NCT00239577|FG001|Participant Flow|Dengue Formulation 17b Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
10841508|NCT00239577|FG002|Participant Flow|Dengue Formulation 19 Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
10841509|NCT00239577|FG003|Participant Flow|Placebo Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841510|NCT00239577|OG000|Outcome|Dengue Formulation 17a Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841511|NCT00239577|OG001|Outcome|Dengue Formulation 17b Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
10841512|NCT00239577|OG002|Outcome|Dengue Formulation 19 Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
10841513|NCT00239577|OG003|Outcome|Placebo Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841514|NCT00239577|OG000|Outcome|Dengue Formulation 17b Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
10841515|NCT00239577|OG001|Outcome|Dengue Formulation 19 Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
10841516|NCT00239577|EG000|Reported Event|Dengue Formulation 17a Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841517|NCT00239577|EG001|Reported Event|Dengue Formulation 17b Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
10841518|NCT00239577|EG002|Reported Event|Dengue Formulation 19 Group|Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
10841519|NCT00239577|EG003|Reported Event|Placebo Group|Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
10841520|NCT00239590|BG000|Baseline|All Study Participants|All participants randomized to study medication (n=28), whether randomized to testosterone or placebo first.
10841521|NCT00239590|FG000|Participant Flow|Testosterone (First, Then Placebo)|"oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks.~At the end of 8 weeks, patients were evaluated, then crossed-over to placebo for 8 weeks. No wash-out period.~Testosterone undecanoate: Licensed for androgen deficiency"
10841522|NCT00239590|FG001|Participant Flow|Placebo (First, Then Testosterone)|"identical to active medication, taken in an identical way to the active arm for 8 weeks.~At the end of the 8 week placebo treatment phase evaluation visit, patients crossed-over to the testosterone treatment arm for 8 weeks. No wash-out period."
10841523|NCT00239590|OG000|Outcome|Testosterone|"Pooled first and second treatment phase data.~oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks.~Testosterone undecanoate: Licensed for androgen deficiency"
10841524|NCT00239590|OG001|Outcome|Placebo|pooled first and second treatment phase data
10841525|NCT00239590|OG000|Outcome|Testosterone|"oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks~Testosterone undecanoate: Licensed for androgen deficiency~Active and placebo given in a cross-over design"
10841526|NCT00239590|OG001|Outcome|Placebo|identical to active medication, taken in an identical way to the active arm
10841527|NCT00239590|EG000|Reported Event|Testosterone|"oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks~Testosterone undecanoate: Licensed for androgen deficiency~Active and placebo given in a cross-over design"
10841528|NCT00239590|EG001|Reported Event|Placebo|identical to active medication, taken in an identical way to the active arm
10841529|NCT00239642|BG000|Baseline|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841530|NCT00239642|BG001|Baseline|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841531|NCT00239642|BG002|Baseline|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841532|NCT00239642|BG003|Baseline|Total|Total of all reporting groups
10841533|NCT00239642|FG000|Participant Flow|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841534|NCT00239642|FG001|Participant Flow|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841535|NCT00239642|FG002|Participant Flow|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841536|NCT00239642|OG000|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841537|NCT00239642|OG001|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841538|NCT00239642|OG002|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841539|NCT00239642|EG000|Reported Event|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841540|NCT00239642|EG001|Reported Event|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841541|NCT00239642|EG002|Reported Event|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
10841542|NCT00239681|BG000|Baseline|Rosuvastatin|Rosuvastatin 20 mg once daily
10841543|NCT00239681|BG001|Baseline|Placebo|Placebo once daily
10841544|NCT00239681|BG002|Baseline|Total|Total of all reporting groups
10841545|NCT00239681|FG000|Participant Flow|Rosuvastatin|Rosuvastatin 20 mg once daily
10841546|NCT00239681|FG001|Participant Flow|Placebo|Placebo once daily
10841547|NCT00239681|OG000|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
10841548|NCT00239681|OG001|Outcome|Placebo|Placebo once daily
10841549|NCT00239681|EG000|Reported Event|PLACEBO|
10841550|NCT00239681|EG001|Reported Event|ROSUVASTATIN 20 MG|
10841551|NCT00239733|BG000|Baseline|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
10841552|NCT00239733|FG000|Participant Flow|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
10841553|NCT00239733|OG000|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
10841554|NCT00239733|EG000|Reported Event|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
10841555|NCT00239837|BG000|Baseline|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
10841556|NCT00239837|BG001|Baseline|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
10841557|NCT00239837|BG002|Baseline|Total|Total of all reporting groups
10841558|NCT00239837|FG000|Participant Flow|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
10841559|NCT00239837|FG001|Participant Flow|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
10841560|NCT00239837|OG000|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
10841561|NCT00239837|OG001|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
10841562|NCT00239837|OG000|Outcome|Middle School Success Intervention (MSS)|"Middle School Success Intervention (MSS): Participants receive the preventative intervention~Middle School Success Intervention (MSS): This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school."
10841563|NCT00239837|OG001|Outcome|Foster Care Services as Usual|Foster Care Services as Usual: Participants continue with usual foster care
10841564|NCT00239837|EG000|Reported Event|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
10841565|NCT00239837|EG001|Reported Event|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
10841566|NCT00239928|BG000|Baseline|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
10841567|NCT00239928|FG000|Participant Flow|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
10841568|NCT00239928|OG000|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
10841569|NCT00239928|EG000|Reported Event|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
10841570|NCT00240071|BG000|Baseline|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
10841571|NCT00240071|FG000|Participant Flow|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
10841572|NCT00240071|OG000|Outcome|Avastin (Bevacizumab) Plus Hormone|All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
10841573|NCT00240071|OG000|Outcome|Avastin|"The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin.~Avastin: All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.~Hormonal therapy: aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)"
10841574|NCT00240071|EG000|Reported Event|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
10841575|NCT00240097|BG000|Baseline|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
10841576|NCT00240097|FG000|Participant Flow|Regimen A and B|"Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)~Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)"
10841577|NCT00240097|OG000|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
10841578|NCT00240097|OG000|Outcome|Part II - After Relapse|Study dosing with A and B based on relapse
10841579|NCT00240097|EG000|Reported Event|Regimen A First Cycle|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
10841580|NCT00240097|EG001|Reported Event|Regimen B First Cycle|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
10841581|NCT00240097|EG002|Reported Event|Regimen A Overall Toxicity|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
10841582|NCT00240097|EG003|Reported Event|Regimen B Overall Toxicity|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
10841583|NCT00240110|BG000|Baseline|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
10841584|NCT00240110|BG001|Baseline|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
10841585|NCT00240110|BG002|Baseline|Total|Total of all reporting groups
10841586|NCT00240110|FG000|Participant Flow|Lithium Carbonate Add on Placebo|Lithium started and then participants randomized to placebo
10841587|NCT00240110|FG001|Participant Flow|Lithium Carbonate Add on Valproate|Lithium carbonate started and participants randomized to valproate
10841588|NCT00240110|OG000|Outcome|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
10841589|NCT00240110|OG001|Outcome|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
10841590|NCT00240110|OG000|Outcome|Lithium Carbonate Add on Placebo|Open label lithium carbonate as standard treatment and double blinded placebo
10841591|NCT00240110|OG001|Outcome|Lithium Carbonate Add on Valproate|Open label lithium carbonate as standard treatment and double blinded valproate
10841592|NCT00240110|EG000|Reported Event|Lithium Carbonate Add on Placebo|Lithium carbonate as standard treatment add on double blind placebo
10841593|NCT00240110|EG001|Reported Event|Lithium Carbonate Add on Valproate|Lithium carbonate as standard treatment add on double blind valproate
10841594|NCT00240162|BG000|Baseline|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
10841595|NCT00240162|FG000|Participant Flow|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
10841596|NCT00240162|OG000|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
10841597|NCT00240162|EG000|Reported Event|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
10841598|NCT00240331|BG000|Baseline|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
10841599|NCT00240331|BG001|Baseline|Placebo|Matching placebo
10841600|NCT00240331|BG002|Baseline|Total|Total of all reporting groups
10841601|NCT00240331|FG000|Participant Flow|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
10841602|NCT00240331|FG001|Participant Flow|Placebo|Matching placebo
10841603|NCT00240331|OG000|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
10841604|NCT00240331|OG001|Outcome|Placebo|Matching placebo
10841605|NCT00240331|EG000|Reported Event|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
10841606|NCT00240331|EG001|Reported Event|Placebo|Matching placebo
10841607|NCT00240487|BG000|Baseline|Nitric Oxide First|Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
10841608|NCT00240487|BG001|Baseline|Delayed Nitric Oxide|Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
10841609|NCT00240487|BG002|Baseline|Total|Total of all reporting groups
10841610|NCT00240487|FG000|Participant Flow|Nitric Oxide First|Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.
10841611|NCT00240487|FG001|Participant Flow|Delayed Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
10841612|NCT00240487|OG000|Outcome|Immediate Nitric Oxide Treatment|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.
10841613|NCT00240487|OG001|Outcome|Delayed Nitric Oxide Treatment|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
10841614|NCT00240487|EG000|Reported Event|Immediate Treatment With Nitric Oxide|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours.
10841615|NCT00240487|EG001|Reported Event|Delayed Treatment With Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
10841616|NCT00240526|BG000|Baseline|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841617|NCT00240526|BG001|Baseline|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841618|NCT00240526|BG002|Baseline|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
10841619|NCT00240526|BG003|Baseline|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
10841620|NCT00240526|BG004|Baseline|Total|Total of all reporting groups
10841621|NCT00240526|FG000|Participant Flow|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841622|NCT00240526|FG001|Participant Flow|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841623|NCT00240526|FG002|Participant Flow|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
10841624|NCT00240526|FG003|Participant Flow|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
10841625|NCT00240526|OG000|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841626|NCT00240526|OG001|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841627|NCT00240526|OG002|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
10841628|NCT00240526|OG003|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
10841629|NCT00240526|OG000|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841630|NCT00240526|OG001|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841631|NCT00240526|OG002|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
10841632|NCT00240526|OG003|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
10841633|NCT00240526|EG000|Reported Event|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841634|NCT00240526|EG001|Reported Event|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
10841635|NCT00240526|EG002|Reported Event|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
10841636|NCT00240526|EG003|Reported Event|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
10841637|NCT00240539|BG000|Baseline|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
10841638|NCT00240539|BG001|Baseline|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
10841639|NCT00240539|BG002|Baseline|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
10841640|NCT00240539|BG003|Baseline|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
10841641|NCT00240539|BG004|Baseline|Total|Total of all reporting groups
10841642|NCT00240539|FG000|Participant Flow|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
10841643|NCT00240539|FG001|Participant Flow|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
10841644|NCT00240539|FG002|Participant Flow|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
10841645|NCT00240539|FG003|Participant Flow|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
10841646|NCT00240539|OG000|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
10841647|NCT00240539|OG001|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
10841648|NCT00240539|OG002|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
10841649|NCT00240539|OG003|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
10841650|NCT00240539|EG000|Reported Event|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
10841651|NCT00240539|EG001|Reported Event|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
10841652|NCT00240539|EG002|Reported Event|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
10841653|NCT00240539|EG003|Reported Event|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
10841654|NCT00240981|BG000|Baseline|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
10841655|NCT00240981|BG001|Baseline|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
10841656|NCT00240981|BG002|Baseline|Total|Total of all reporting groups
10841657|NCT00240981|FG000|Participant Flow|Treatment|
10841658|NCT00240981|FG001|Participant Flow|Placebo|
10841659|NCT00240981|OG000|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
10841660|NCT00240981|OG001|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
10841661|NCT00240981|OG000|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
10841662|NCT00240981|EG000|Reported Event|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
10841663|NCT00240981|EG001|Reported Event|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
10841664|NCT00240994|BG000|Baseline|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
10841665|NCT00240994|FG000|Participant Flow|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
10841666|NCT00240994|OG000|Outcome|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
10848210|NCT00289120|EG001|Reported Event|Deionized Water Drinking Phase|"Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~No adverse event reported."
10841667|NCT00240994|EG000|Reported Event|Alemtuzumab (Campath)|In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
10841668|NCT00241176|BG000|Baseline|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
10841669|NCT00241176|FG000|Participant Flow|Aripiprazole|Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
10841670|NCT00241176|OG000|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
10841671|NCT00241176|OG001|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
10841672|NCT00241176|EG000|Reported Event|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
10841673|NCT00241280|BG000|Baseline|Control: Etafilcon A|Subjects that were randomized to receive the Control lens etafilcon A
10841674|NCT00241280|BG001|Baseline|Test: Galyfilcon A|Subjects that were randomized to receive the Test lens galyfilcon A
10841675|NCT00241280|BG002|Baseline|Total|Total of all reporting groups
10841676|NCT00241280|FG000|Participant Flow|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
10841677|NCT00241280|FG001|Participant Flow|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
10841678|NCT00241280|OG000|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
10841679|NCT00241280|OG001|Outcome|Test: Galyfilcon A|"Subjects that were randomly assigned to wear the Test lens.~It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing."
10841680|NCT00241280|OG001|Outcome|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
10841681|NCT00241280|EG000|Reported Event|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
10841682|NCT00241280|EG001|Reported Event|Test: Galyfilcon A|Subjects that were randomly assigned to wear Test lens.
10841683|NCT00241358|BG000|Baseline|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841684|NCT00241358|BG001|Baseline|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
10841685|NCT00241358|BG002|Baseline|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841686|NCT00241358|BG003|Baseline|Total|Total of all reporting groups
10841687|NCT00241358|FG000|Participant Flow|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841688|NCT00241358|FG001|Participant Flow|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
10841689|NCT00241358|FG002|Participant Flow|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841690|NCT00241358|OG000|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841691|NCT00241358|OG001|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
10841692|NCT00241358|OG002|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
10841693|NCT00241358|EG000|Reported Event|Donors|AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
10841694|NCT00241358|EG001|Reported Event|Recipients|Stem Cell Transplantation Day 0
10841695|NCT00241631|BG000|Baseline|Placebo|Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline
10841696|NCT00241631|BG001|Baseline|Steroid|Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
10841697|NCT00241631|BG002|Baseline|Total|Total of all reporting groups
10841698|NCT00241631|FG000|Participant Flow|Placebo|Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline
10841699|NCT00241631|FG001|Participant Flow|Steroid|Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
10841700|NCT00241631|OG000|Outcome|Placebo|Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline
10841701|NCT00241631|OG001|Outcome|Steroid|Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
10841702|NCT00241631|EG000|Reported Event|Placebo|Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline
10841703|NCT00241631|EG001|Reported Event|Steroid|Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
10841704|NCT00241644|BG000|Baseline|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
10841705|NCT00241644|BG001|Baseline|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
10841706|NCT00241644|BG002|Baseline|Placebo Group|Subjects received 3 doses of placebo.
10841707|NCT00241644|BG003|Baseline|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
10841708|NCT00241644|BG004|Baseline|Total|Total of all reporting groups
10841709|NCT00241644|FG000|Participant Flow|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
10841710|NCT00241644|FG001|Participant Flow|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
10841711|NCT00241644|FG002|Participant Flow|Placebo Group|Subjects received 3 doses of placebo.
10841712|NCT00241644|FG003|Participant Flow|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
10841713|NCT00241644|OG000|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
10841714|NCT00241644|OG001|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
10841715|NCT00241644|OG002|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
10841716|NCT00241644|OG003|Outcome|Placebo Group|Subjects received 3 doses of placebo.
10841717|NCT00241644|EG000|Reported Event|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
10841718|NCT00241644|EG001|Reported Event|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
10841719|NCT00241644|EG002|Reported Event|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
10841720|NCT00241644|EG003|Reported Event|Placebo Group|Subjects received 3 doses of placebo.
10841721|NCT00241839|BG000|Baseline|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841722|NCT00241839|BG001|Baseline|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841723|NCT00241839|BG002|Baseline|Total|Total of all reporting groups
10841724|NCT00241839|FG000|Participant Flow|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841725|NCT00241839|FG001|Participant Flow|B(Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841726|NCT00241839|OG000|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841727|NCT00241839|OG001|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841728|NCT00241839|EG000|Reported Event|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10848211|NCT00289133|BG000|Baseline|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
10848212|NCT00289133|BG001|Baseline|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
10848213|NCT00289133|BG002|Baseline|Total|Total of all reporting groups
10848214|NCT00289133|FG000|Participant Flow|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
10841729|NCT00241839|EG001|Reported Event|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
10841730|NCT00241904|BG000|Baseline|Comprehensive Intervention|CI intervention will receive Behavioral: Lifestyle Changes, Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercises, as well as pharmacologic agents
10841731|NCT00241904|BG001|Baseline|Less Intensive Intervention|LI Arm: Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.
10841732|NCT00241904|BG002|Baseline|Total|Total of all reporting groups
10841733|NCT00241904|FG000|Participant Flow|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms.Participants will receive a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians.~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
10841734|NCT00241904|FG001|Participant Flow|Less Intensive Intervention (Usual Care) Group|Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.
10841735|NCT00241904|OG000|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
10841736|NCT00241904|OG001|Outcome|Less Intensive Intervention Group|"Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
10841737|NCT00241904|OG000|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors:Oral medications, received 1-2 times per day"
10841738|NCT00241904|EG000|Reported Event|Comprehensive Intervention Group|
10841739|NCT00241904|EG001|Reported Event|Less Intensive Intervention|
10841740|NCT00241969|BG000|Baseline|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
10841741|NCT00241969|BG001|Baseline|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
10841742|NCT00241969|BG002|Baseline|Total|Total of all reporting groups
10841743|NCT00241969|FG000|Participant Flow|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
10841744|NCT00241969|FG001|Participant Flow|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
10841745|NCT00241969|OG000|Outcome|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
10841746|NCT00241969|OG001|Outcome|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
10841747|NCT00241969|EG000|Reported Event|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
10841748|NCT00241969|EG001|Reported Event|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
10841749|NCT00242216|BG000|Baseline|Atazanavir|
10841750|NCT00242216|BG001|Baseline|Fosamprenavir|
10841751|NCT00242216|BG002|Baseline|Total|Total of all reporting groups
10841752|NCT00242216|FG000|Participant Flow|Atazanavir|Atazanavir/ritonavir (300mg/100mg) once daily
10841753|NCT00242216|FG001|Participant Flow|Fosamprenavir|Fosamprenavir/ritonavir (1400mg/100mg) once daily
10841754|NCT00242216|OG000|Outcome|Atazanavir|
10841755|NCT00242216|OG001|Outcome|Fosamprenavir|
10841756|NCT00242216|EG000|Reported Event|Atazanavir|
10841757|NCT00242216|EG001|Reported Event|Fosamprenavir|
10841758|NCT00242385|BG000|Baseline|Subjects With Severe Congenital α1-PI Deficiency|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
10841759|NCT00242385|FG000|Participant Flow|ARALAST Fr. IV-1 Then Aralast|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
10841760|NCT00242385|FG001|Participant Flow|ARALAST Then ARALAST Fr. IV-1|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
10841761|NCT00242385|OG000|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
10841762|NCT00242385|OG001|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
10841763|NCT00242385|EG000|Reported Event|ARALAST Fr. IV-1|Subjects received a single dose of ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min
10841764|NCT00242385|EG001|Reported Event|ARALAST|Subjects received a single dose of ARALAST 60 mg/kg at 0.2 mL/kg/min
10841765|NCT00242502|BG000|Baseline|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
10841766|NCT00242502|FG000|Participant Flow|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
10841767|NCT00242502|OG000|Outcome|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
10841768|NCT00242502|EG000|Reported Event|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
10841769|NCT00242567|BG000|Baseline|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
10841770|NCT00242567|BG001|Baseline|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
10841771|NCT00242567|BG002|Baseline|Total|Total of all reporting groups
10841772|NCT00242567|FG000|Participant Flow|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
10841773|NCT00242567|FG001|Participant Flow|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
10841774|NCT00242567|OG000|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
10841775|NCT00242567|OG001|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
10841776|NCT00242567|EG000|Reported Event|Early Group|Early Group
10841777|NCT00242567|EG001|Reported Event|Delayed Group (Overall)|Delayed Group (Overall)
10841778|NCT00242567|EG002|Reported Event|Delayed Group (No Zometa)|Delayed Group (No Zometa)
10841779|NCT00242567|EG003|Reported Event|Delayed Group (Zometa)|Delayed Group (Zometa)
10841780|NCT00242580|BG000|Baseline|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841781|NCT00242580|BG001|Baseline|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841782|NCT00242580|BG002|Baseline|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
10841783|NCT00242580|BG003|Baseline|Total|Total of all reporting groups
10841784|NCT00242580|FG000|Participant Flow|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10848215|NCT00289133|FG001|Participant Flow|XLK Poly|Cross-linked polyethylene tibial component
10841785|NCT00242580|FG001|Participant Flow|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841786|NCT00242580|FG002|Participant Flow|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
10841787|NCT00242580|OG000|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841788|NCT00242580|OG001|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841789|NCT00242580|OG002|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
10841790|NCT00242580|EG000|Reported Event|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841791|NCT00242580|EG001|Reported Event|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
10841792|NCT00242580|EG002|Reported Event|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
10841793|NCT00242619|BG000|Baseline|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
10841794|NCT00242619|BG001|Baseline|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
10841795|NCT00242619|BG002|Baseline|Total|Total of all reporting groups
10841796|NCT00242619|FG000|Participant Flow|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
10841797|NCT00242619|FG001|Participant Flow|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
10841798|NCT00242619|OG000|Outcome|Completers|Subjects who completed the study.
10841799|NCT00242619|OG001|Outcome|Drop-Outs|Subjects who dropped out of the study.
10841800|NCT00242619|OG000|Outcome|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
10841801|NCT00242619|OG001|Outcome|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
10841802|NCT00242619|EG000|Reported Event|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
10841803|NCT00242619|EG001|Reported Event|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
10841804|NCT00242632|BG000|Baseline|apoE-e4-|Subjects without the apoE-e4 allele
10841805|NCT00242632|BG001|Baseline|apoE-e4+|Subjects with the apoE-e4 allele
10841806|NCT00242632|BG002|Baseline|Total|Total of all reporting groups
10841807|NCT00242632|FG000|Participant Flow|apoE-e4-|Subjects without the apoE-e4 allele
10841808|NCT00242632|FG001|Participant Flow|apoE-e4+|Subjects with the apoE-e4 allele
10841809|NCT00242632|OG000|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
10841810|NCT00242632|EG000|Reported Event|ApoE-e4+|This includes the 11 subjects who were carriers of the ApoE-e4 allele.
10841811|NCT00242632|EG001|Reported Event|ApoE-e4-|This includes the 11 subjects who were non-carriers of the ApoE-e4 allele.
10841812|NCT00242658|BG000|Baseline|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.
10841813|NCT00242658|BG001|Baseline|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
10841814|NCT00242658|BG002|Baseline|Total|Total of all reporting groups
10841815|NCT00242658|FG000|Participant Flow|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.
10841816|NCT00242658|FG001|Participant Flow|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
10841817|NCT00242658|OG000|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.
10841818|NCT00242658|OG001|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
10841819|NCT00242658|EG000|Reported Event|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.
10841820|NCT00242658|EG001|Reported Event|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
10841821|NCT00242684|BG000|Baseline|Transitional Care Unit Veterans|older patients admitted to a TCU unit
10841822|NCT00242684|FG000|Participant Flow|Transitional Care Unit Veterans|older patients admitted to a TCU unit
10841823|NCT00242684|OG000|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
10841824|NCT00242684|EG000|Reported Event|Transitional Care Unit Veterans|older patients admitted to a TCU unit
10841825|NCT00242710|BG000|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
10841826|NCT00242710|BG001|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841827|NCT00242710|BG002|Baseline|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841828|NCT00242710|BG003|Baseline|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841829|NCT00242710|BG004|Baseline|Total|Total of all reporting groups
10841830|NCT00242710|FG000|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
10841831|NCT00242710|FG001|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841832|NCT00242710|FG002|Participant Flow|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841833|NCT00242710|FG003|Participant Flow|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10848216|NCT00289133|OG000|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
10848217|NCT00289133|OG001|Outcome|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
10841834|NCT00242710|OG000|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
10841835|NCT00242710|OG001|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841836|NCT00242710|OG002|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841837|NCT00242710|OG003|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841838|NCT00242710|EG000|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
10841839|NCT00242710|EG001|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841840|NCT00242710|EG002|Reported Event|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841841|NCT00242710|EG003|Reported Event|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
10841842|NCT00243022|BG000|Baseline|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
10841843|NCT00243022|BG001|Baseline|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
10841844|NCT00243022|BG002|Baseline|Total|Total of all reporting groups
10841845|NCT00243022|FG000|Participant Flow|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
10841846|NCT00243022|FG001|Participant Flow|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/day given orally"
10841847|NCT00243022|OG000|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
10841848|NCT00243022|OG001|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
10841849|NCT00243022|OG001|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/day given orally"
10841850|NCT00243022|EG000|Reported Event|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
10841851|NCT00243022|EG001|Reported Event|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
10841852|NCT00243061|BG000|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
10841853|NCT00243061|FG000|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
10841854|NCT00243061|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
10848218|NCT00289133|OG000|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
10848219|NCT00289133|OG001|Outcome|XLK Poly|Cross-linked polyethylene
10841855|NCT00243061|OG000|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
10841856|NCT00243061|EG000|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
10841857|NCT00243074|BG000|Baseline|AZD2171|
10841858|NCT00243074|FG000|Participant Flow|AZD2171 (Cediranib Maleate)|
10841859|NCT00243074|OG000|Outcome|AZD2171 (Cediranib Maleate)|
10841860|NCT00243074|OG000|Outcome|AZD2171|
10841861|NCT00243074|EG000|Reported Event|AZD2171|
10841862|NCT00243152|BG000|Baseline|Lamotrigine|"The drug lamotrigine or placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided during both arms of the study for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period lamotrigine or placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug/placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Lamotrigine: : 25mg and 50mg tablets"
10841863|NCT00243152|FG000|Participant Flow|Lamotrigine to Placebo Crossover|"The drug lamotrigine taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Lamotrigine: : 25mg and 50mg tablets"
10841864|NCT00243152|FG001|Participant Flow|Placebo to Lamotrigine Crossover|Placebo is taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period the drug, Lamotrigine (cross over), will be administered. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
10841865|NCT00243152|OG000|Outcome|Lamotrigine vs Placebo|The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Placebo will be administered in another imaging session. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
10841866|NCT00243152|OG000|Outcome|Placebo|"The placebo will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Placebo (for Lamotrigine): Sugar pill manufactured to mimic Lamotrigine tablets"
10841867|NCT00243152|OG001|Outcome|Lamotrigine|"The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Lamotrigine: : 25mg and 50mg tablets"
10841868|NCT00243152|EG000|Reported Event|Lamotrigine|"The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Lamotrigine: : 25mg and 50mg tablets"
10841869|NCT00243152|EG001|Reported Event|Placebo|"The placebo will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.~Placebo (for Lamotrigine): Sugar pill manufactured to mimic Lamotrigine tablets"
10841870|NCT00243191|BG000|Baseline|Imatinib|
10841871|NCT00243191|FG000|Participant Flow|Imatinib|
10841872|NCT00243191|OG000|Outcome|Imatinib|
10841873|NCT00243191|EG000|Reported Event|Imatinib|
10841874|NCT00243230|BG000|Baseline|Double-Blind Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.
10841875|NCT00243230|BG001|Baseline|Double-Blind Period - Vicriviroc 20 mg Plus an ART Regimen|Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841876|NCT00243230|BG002|Baseline|Double-Blind Period - Placebo Plus an ART Regimen|Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841877|NCT00243230|BG003|Baseline|Total|Total of all reporting groups
10848220|NCT00289133|OG000|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
10848221|NCT00289133|OG001|Outcome|XLK Poly|Cross-linked polyethylene tibial component
10841878|NCT00243230|FG000|Participant Flow|Double-Blind Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.
10841879|NCT00243230|FG001|Participant Flow|Double-Blind Period - Vicriviroc 20 mg Plus an ART Regimen|Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841880|NCT00243230|FG002|Participant Flow|Double-Blind Period - Placebo Plus an ART Regimen|Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841881|NCT00243230|FG003|Participant Flow|Open-Label Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months.
10841882|NCT00243230|OG000|Outcome|Double-Blind Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.
10841883|NCT00243230|OG001|Outcome|Double-Blind Period - Vicriviroc 20 mg Plus an ART Regimen|Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841884|NCT00243230|OG002|Outcome|Double-Blind Period - Placebo Plus an ART Regimen|Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841885|NCT00243230|OG000|Outcome|Open-Label Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months.
10841886|NCT00243230|EG000|Reported Event|Double-Blind Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.
10841887|NCT00243230|EG001|Reported Event|Double-Blind Period - Vicriviroc 20 mg Plus an ART Regimen|Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841888|NCT00243230|EG002|Reported Event|Double-Blind Period - Placebo Plus an ART Regimen|Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
10841889|NCT00243230|EG003|Reported Event|Open-Label Period - Vicriviroc 30 mg Plus an ART Regimen|Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months.
10841890|NCT00243243|BG000|Baseline|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
10841891|NCT00243243|BG001|Baseline|Control|
10841892|NCT00243243|BG002|Baseline|Total|Total of all reporting groups
10841893|NCT00243243|FG000|Participant Flow|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
10841894|NCT00243243|FG001|Participant Flow|Control- Placebo|Intravenous infusion of a placebo
10841895|NCT00243243|OG000|Outcome|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
10841896|NCT00243243|OG001|Outcome|Control- Placebo|Intravenous infusion of a placebo
10841897|NCT00243243|EG000|Reported Event|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
10841898|NCT00243243|EG001|Reported Event|Control|
10841899|NCT00243269|BG000|Baseline|Control Handout and Control Tape.|"Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study. Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841900|NCT00243269|BG001|Baseline|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, Wear Seabands for up to five days as needed to prevent or alleviate nausea. Patients' names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841901|NCT00243269|BG002|Baseline|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
10841902|NCT00243269|BG003|Baseline|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
10841903|NCT00243269|BG004|Baseline|Total|Total of all reporting groups
10842963|NCT00250926|OG000|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
10841904|NCT00243269|FG000|Participant Flow|Control Handout and Control Tape.|"Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study. Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841905|NCT00243269|FG001|Participant Flow|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, Wear Seabands for up to five days as needed to prevent or alleviate nausea. Patients' names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841906|NCT00243269|FG002|Participant Flow|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
10841907|NCT00243269|FG003|Participant Flow|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
10841908|NCT00243269|OG000|Outcome|Control Handout and Control Tape.|"Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study. Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841909|NCT00243269|OG001|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, Wear Seabands for up to five days as needed to prevent or alleviate nausea. Patients' names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841910|NCT00243269|OG002|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
10841911|NCT00243269|OG003|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
10841912|NCT00243269|EG000|Reported Event|Control Handout and Control Tape.|"Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study. Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10842964|NCT00250926|EG000|Reported Event|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
10848222|NCT00289133|EG000|Reported Event|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
10848223|NCT00289133|EG001|Reported Event|XLK Poly|Cross-linked polyethylene tibial component
10841913|NCT00243269|EG001|Reported Event|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, Wear Seabands for up to five days as needed to prevent or alleviate nausea. Patients' names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
10841914|NCT00243269|EG002|Reported Event|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
10841915|NCT00243269|EG003|Reported Event|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
10841916|NCT00243347|BG000|Baseline|Cediranib 30 mg|Cediranib 30mg/Day
10841917|NCT00243347|FG000|Participant Flow|Cediranib 30 mg|Cediranib 30mg/Day
10841918|NCT00243347|OG000|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
10841919|NCT00243347|EG000|Reported Event|Cediranib 30 mg|Cediranib 30mg/Day
10841920|NCT00243386|BG000|Baseline|All Study Participants|Participants first underwent an open-label evaluation of rAHF-PFM PK. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
10841921|NCT00243386|FG000|Participant Flow|All Study Participants|Participants first underwent an open-label pharmacokinetic (PK) evaluation of rAHF-PFM. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
10841922|NCT00243386|FG001|Participant Flow|PK-Driven Prophylaxis|The PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg of rAHF-PFM every 72 ±6 hours
10841923|NCT00243386|FG002|Participant Flow|Standard Prophylaxis|The standard prophylactic regimen was dosed at 20 to 40 IU/kg of rAHF-PFM every 48 ±6 hours
10841924|NCT00243386|OG000|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
10841925|NCT00243386|OG001|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
10841926|NCT00243386|OG000|Outcome|On-Demand Versus Standard Prophylaxis|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, Gastrointestinal (GI), and intracranial (60-100 IU/kg every 8-12 hours) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
10841927|NCT00243386|OG000|Outcome|On-Demand Versus PK-Driven Prophylaxis|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours) PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
10841928|NCT00243386|OG000|Outcome|On-Demand Versus Any Prophylaxis|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours) Prophylaxis: •Standard prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator •PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
10841929|NCT00243386|OG000|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
10841930|NCT00243386|OG001|Outcome|Standard Prophylaxis Treatment|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
10841931|NCT00243386|OG002|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
10841932|NCT00243386|OG000|Outcome|On-Demand Regimen|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
10841933|NCT00243386|OG001|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
10841934|NCT00243386|OG000|Outcome|≥14 Years of Age|
10841935|NCT00243386|OG001|Outcome|<14 Years of Age|
10841936|NCT00243386|OG000|Outcome|All Study Participants|All participants who were exposed to Investigational Product (IP)
10841937|NCT00243386|OG000|Outcome|All Study Participants|All participants who were exposed to IP
10841938|NCT00243386|OG000|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
10841939|NCT00243386|OG000|Outcome|On-Demand|
10841940|NCT00243386|OG003|Outcome|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
10841941|NCT00243386|OG000|Outcome|All Study Participants|All participants who were exposed to investigational product (IP)
10841942|NCT00243386|OG000|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
10841943|NCT00243386|OG000|Outcome|Assessed Before Treatment|
10841944|NCT00243386|OG000|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
10841945|NCT00243386|OG003|Outcome|Any Prophylaxis Treatment|Any Prophylaxis Treatment (either Standard Prophylaxis or PK-Driven Prophylaxis) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator PK-Driven Prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
10841946|NCT00243386|OG000|Outcome|On-Demand to Standard Prophylaxis|
10841947|NCT00243386|OG001|Outcome|On-Demand to PK-Driven Prophylaxis|
10841948|NCT00243386|OG002|Outcome|On-Demand to Any Prophylaxis Treatment|
10841949|NCT00243386|OG000|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
10841950|NCT00243386|OG000|Outcome|On-Demand Regimen|After the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1)
10841951|NCT00243386|OG001|Outcome|Standard Prophylaxis|Dosed at 20 to 40 IU/kg every 48 ±6 hours for 12 months (Part 2)
10841952|NCT00243386|OG002|Outcome|PK-driven Prophylaxis|Dosed at 20 to 80 IU/kg every 72 ±6 hours for 12 months (Part 2)
10841953|NCT00243386|OG003|Outcome|Any Prophylaxis|Either Standard or PK-driven Prophylaxis
10841954|NCT00243386|EG000|Reported Event|On-Demand|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
10841955|NCT00243386|EG001|Reported Event|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg (every 48 ±6 hours), exact regimen to be determined by the investigator
10841956|NCT00243386|EG002|Reported Event|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg (every 72 ±6 hours) exact regimen to be determined by the sponsor
10841957|NCT00243386|EG003|Reported Event|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
10841958|NCT00243412|BG000|Baseline|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841959|NCT00243412|BG001|Baseline|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841960|NCT00243412|BG002|Baseline|Total|Total of all reporting groups
10841961|NCT00243412|FG000|Participant Flow|Arm A: 500 mg Rituximab|Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841962|NCT00243412|FG001|Participant Flow|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion, For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841963|NCT00243412|OG000|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841964|NCT00243412|OG001|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841965|NCT00243412|EG000|Reported Event|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841966|NCT00243412|EG001|Reported Event|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
10841967|NCT00243503|BG000|Baseline|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
10841968|NCT00243503|FG000|Participant Flow|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
10841969|NCT00243503|OG000|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
10841970|NCT00243503|OG000|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles
10841971|NCT00243503|EG000|Reported Event|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
10841972|NCT00243659|BG000|Baseline|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
10841973|NCT00243659|BG001|Baseline|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
10841974|NCT00243659|BG002|Baseline|Total|Total of all reporting groups
10841975|NCT00243659|FG000|Participant Flow|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
10841976|NCT00243659|FG001|Participant Flow|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
10841977|NCT00243659|OG000|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
10841978|NCT00243659|OG001|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
10841979|NCT00243659|EG000|Reported Event|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
10841980|NCT00243659|EG001|Reported Event|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
10841981|NCT00243841|BG000|Baseline|Phase I|Dose escalation to 48 Gy (16Gy/fraction) in Childs A and to 42 Gy (14 Gy/fraction) down to 40 Gy (8Gy/fraction) for Childs B
10841982|NCT00243841|BG001|Baseline|Phase II Childs A|Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days
10841983|NCT00243841|BG002|Baseline|Phase II Childs B|Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks.
10841984|NCT00243841|BG003|Baseline|Total|Total of all reporting groups
10841985|NCT00243841|FG000|Participant Flow|Phase I: 36 Gy|Patients will receive 1200 cGy x 3 fractions of radiation
10841986|NCT00243841|FG001|Participant Flow|Phase I: 42 Gy|Patients will receive 1400 cGy x 3 fractions of radiation
10841987|NCT00243841|FG002|Participant Flow|Phase I: 40 Gy|Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction)
10841988|NCT00243841|FG003|Participant Flow|Phase I: 48 Gy|Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only
10841989|NCT00243841|FG004|Participant Flow|Phase II Childs A|Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days
10841990|NCT00243841|FG005|Participant Flow|Phase II Childs B|Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks.
10841991|NCT00243841|OG000|Outcome|Phase I: 36 Gy|Patients will receive 1200 cGy x 3 fractions of radiation
10841992|NCT00243841|OG001|Outcome|Phase I: 42 Gy|Patients will receive 1400 cGy x 3 fractions of radiation
10841993|NCT00243841|OG002|Outcome|Phase I: 40 Gy|Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction)
10841994|NCT00243841|OG003|Outcome|Phase I: 48 Gy|Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only
10841995|NCT00243841|OG000|Outcome|Phase II Childs A|Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days
10841996|NCT00243841|OG001|Outcome|Phase II Childs B|Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks.
10841997|NCT00243841|OG000|Outcome|Radiation Treatment Arm :A|"Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days~Stereotactic Body Radiation: Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions."
10841998|NCT00243841|OG001|Outcome|Radiation Treatment Arm: B|"Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.~Stereotactic Body Radiation: Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions."
10841999|NCT00243841|EG000|Reported Event|Phase I: 36 Gy|Patients will receive 1200 cGy x 3 fractions of radiation
10842000|NCT00243841|EG001|Reported Event|Phase I: 42 Gy|Patients will receive 1400 cGy x 3 fractions of radiation
10842001|NCT00243841|EG002|Reported Event|Phase I: 40 Gy|Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction)
10842002|NCT00243841|EG003|Reported Event|Phase I: 48 Gy|Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only
10842003|NCT00243841|EG004|Reported Event|Phase II Childs A|Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days
10842004|NCT00243841|EG005|Reported Event|Phase II Childs B|Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks.
10842005|NCT00243919|BG000|Baseline|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
10842006|NCT00243919|BG001|Baseline|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
10842007|NCT00243919|BG002|Baseline|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
10842008|NCT00243919|BG003|Baseline|Total|Total of all reporting groups
10842009|NCT00243919|FG000|Participant Flow|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
10842010|NCT00243919|FG001|Participant Flow|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
10842011|NCT00243919|FG002|Participant Flow|Home Exercise Program|Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
10842012|NCT00243919|OG000|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
10842013|NCT00243919|OG001|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
10842014|NCT00243919|OG002|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
10842015|NCT00243919|EG000|Reported Event|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
10842016|NCT00243919|EG001|Reported Event|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
10842017|NCT00243919|EG002|Reported Event|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
10842018|NCT00243932|BG000|Baseline|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
10842019|NCT00243932|BG001|Baseline|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
10842020|NCT00243932|BG002|Baseline|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
10842021|NCT00243932|BG003|Baseline|Total|Total of all reporting groups
10842022|NCT00243932|FG000|Participant Flow|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
10842023|NCT00243932|FG001|Participant Flow|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
10842024|NCT00243932|FG002|Participant Flow|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
10842025|NCT00243932|OG000|Outcome|2700mg CoQ10|"40 new subjects and 35 subjects from stage 1 all taking 2,700mg CoQ10 - total 75.~Stage 1 - 35 participants per group compared CoQ10 doses of 1,800mg and 2,700 mg/day and placebo."
10842026|NCT00243932|OG001|Outcome|Placebo|40 new subjects plus 35 subjects from stage 1 receiving placebo - total 75.
10842027|NCT00243932|OG002|Outcome|1,800 mg CoQ10|35 patients. Mean and SD are presented but this group was not included in the efficacy analysis because the 1,800 mg dose was discontinued after stage 1.
10842028|NCT00243932|EG000|Reported Event|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
10842029|NCT00243932|EG001|Reported Event|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
10842030|NCT00243932|EG002|Reported Event|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
10842031|NCT00244101|BG000|Baseline|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
10842032|NCT00244101|BG001|Baseline|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
10842033|NCT00244101|BG002|Baseline|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
10842034|NCT00244101|BG003|Baseline|Total|Total of all reporting groups
10842035|NCT00244101|FG000|Participant Flow|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
10842036|NCT00244101|FG001|Participant Flow|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
10842037|NCT00244101|FG002|Participant Flow|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
10842038|NCT00244101|OG000|Outcome|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
10842039|NCT00244101|OG001|Outcome|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
10842040|NCT00244101|OG002|Outcome|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
10842041|NCT00244101|EG000|Reported Event|Prophylactic Surfactant|Prophylactic surfactant followed by mechanical ventilation
10842042|NCT00244101|EG001|Reported Event|Surfactant Extubated to nCPAP|prophylactic surfactant with rapid extubation to bubble nCPAP
10842043|NCT00244101|EG002|Reported Event|NCPAP|initial management with bubble nCPAP and selective surfactant treatment
10842044|NCT00244140|BG000|Baseline|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
10842045|NCT00244140|BG001|Baseline|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
10842046|NCT00244140|BG002|Baseline|Total|Total of all reporting groups
10842047|NCT00244140|FG000|Participant Flow|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
10842048|NCT00244140|FG001|Participant Flow|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
10842049|NCT00244140|OG000|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
10842050|NCT00244140|OG001|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
10842051|NCT00244140|EG000|Reported Event|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
10842052|NCT00244140|EG001|Reported Event|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
10842053|NCT00244374|BG000|Baseline|All Participants|Participants in pre-randomization cross-sectional study
10842054|NCT00244374|FG000|Participant Flow|Cross-sectional/Screening|Cross-sectional screening to determine eligibility for vaccine adherence trial
10842055|NCT00244374|FG001|Participant Flow|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842056|NCT00244374|FG002|Participant Flow|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842057|NCT00244374|FG003|Participant Flow|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842058|NCT00244374|FG004|Participant Flow|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842059|NCT00244374|OG000|Outcome|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842060|NCT00244374|OG001|Outcome|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842061|NCT00244374|OG002|Outcome|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842062|NCT00244374|OG003|Outcome|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842063|NCT00244374|OG000|Outcome|Anti-HCV Positive|Participants tested positive for Hepatitis C Virus (HCV) antibody
10842064|NCT00244374|OG001|Outcome|Anti-HCV Negative|Participants tested negative for Hepatitis C Virus (HCV) antibody
10842065|NCT00244374|OG000|Outcome|Traveled in the Prior 3 Months|"Participants who answered yes when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, and whose last 3 travel destinations were at least 30 miles from San Francisco"
10842066|NCT00244374|OG001|Outcome|Did Not Travel in the Prior 3 Months|"Participants who answered no when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, or whose last 3 travel destinations within 30 miles of San Francisco"
10842067|NCT00244374|OG000|Outcome|Cross-sectional Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
10842068|NCT00244374|OG000|Outcome|Screening Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
10842069|NCT00244374|EG000|Reported Event|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842070|NCT00244374|EG001|Reported Event|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842071|NCT00244374|EG002|Reported Event|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
10842072|NCT00244374|EG003|Reported Event|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
10842073|NCT00244621|BG000|Baseline|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
10842074|NCT00244621|BG001|Baseline|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
10842075|NCT00244621|BG002|Baseline|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
10842076|NCT00244621|BG003|Baseline|Total|Total of all reporting groups
10842077|NCT00244621|FG000|Participant Flow|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
10842078|NCT00244621|FG001|Participant Flow|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
10842079|NCT00244621|FG002|Participant Flow|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
10842080|NCT00244621|OG000|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
10842081|NCT00244621|OG001|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
10842082|NCT00244621|OG002|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
10842083|NCT00244621|EG000|Reported Event|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
10842084|NCT00244621|EG001|Reported Event|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
10842085|NCT00244621|EG002|Reported Event|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
10842086|NCT00244712|BG000|Baseline|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
10842087|NCT00244712|BG001|Baseline|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
10842088|NCT00244712|BG002|Baseline|Total|Total of all reporting groups
10842089|NCT00244712|FG000|Participant Flow|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
10842090|NCT00244712|FG001|Participant Flow|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
10842091|NCT00244712|OG000|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
10842092|NCT00244712|OG001|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
10842093|NCT00244712|EG000|Reported Event|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
10842094|NCT00244712|EG001|Reported Event|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
10842095|NCT00244725|BG000|Baseline|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842096|NCT00244725|BG001|Baseline|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842097|NCT00244725|BG002|Baseline|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842098|NCT00244725|BG003|Baseline|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
10842099|NCT00244725|BG004|Baseline|Total|Total of all reporting groups
10842100|NCT00244725|FG000|Participant Flow|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period.
10842101|NCT00244725|FG001|Participant Flow|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842102|NCT00244725|FG002|Participant Flow|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842103|NCT00244725|FG003|Participant Flow|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
10842104|NCT00244725|OG000|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842105|NCT00244725|OG001|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842106|NCT00244725|OG002|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842107|NCT00244725|OG003|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
10842108|NCT00244725|EG000|Reported Event|ODIPARCIL MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
11331035|NCT03473301|OG002|Outcome|Natural History|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331036|NCT03473301|OG003|Outcome|AlloCB After Natural History|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331037|NCT03473301|EG000|Reported Event|Allogeneic Umbilical Cord Blood (AlloCB)|"Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331038|NCT03473301|EG001|Reported Event|Cord Tissue Mesenchymal Stromal Cells (MSC)|"Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors~Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months)."
11331039|NCT03473301|EG002|Reported Event|Natural History|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331040|NCT03473301|EG003|Reported Event|AlloCB After Natural History|"Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.~Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit."
11331041|NCT03473665|BG000|Baseline|NSAIDs|Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
11331042|NCT03473665|FG000|Participant Flow|NSAIDs|Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
11331043|NCT03473665|OG000|Outcome|NSAIDs x 4 Weeks|NSAIDs x 4 weeks
11331044|NCT03473665|OG001|Outcome|NSAIDs x 6 Weeks|NSAIDs x 6 weeks
11331045|NCT03473665|OG000|Outcome|NSAIDs x 6 Weeks|NSAIDs x 6 weeks
11331046|NCT03473665|EG000|Reported Event|Celecoxib|Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
11331047|NCT03473665|EG001|Reported Event|Meloxicam|Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
11331048|NCT03473665|EG002|Reported Event|Indomethacin|Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
11331049|NCT03473665|EG003|Reported Event|Diclofenac|Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
11331050|NCT03473808|BG000|Baseline|Therapy + Vibration|"Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.~Task-Practice Therapy: Standardized hand therapy program~Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level"
11331051|NCT03473808|FG000|Participant Flow|Therapy + Vibration|"Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.~Task-Practice Therapy: Standardized hand therapy program~Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level"
11331052|NCT03473808|OG000|Outcome|Therapy + Vibration|"Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.~Task-Practice Therapy: Standardized hand therapy program~Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level"
11331053|NCT03473808|EG000|Reported Event|Therapy + Vibration|"Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.~Task-Practice Therapy: Standardized hand therapy program~Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level"
11331054|NCT03473886|BG000|Baseline|Intervention Arm: PP-MI|"Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program.~Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability."
11331055|NCT03473886|FG000|Participant Flow|Intervention Arm: PP-MI|"Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program.~Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability."
11335775|NCT03556579|OG001|Outcome|Control Without Additional Light Source|Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
11335776|NCT03556579|EG000|Reported Event|Test|All subjects that wore the Test lens at either visit 1 or visit 2.
11335777|NCT03556579|EG001|Reported Event|Control|All subjects that wore the Control lens at either visit 1 or visit 2.
10842109|NCT00244725|EG001|Reported Event|ODIPARCIL MR 375 MG TABLET|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842110|NCT00244725|EG002|Reported Event|ODIPARCIL MR 500 MG TABLET|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
10842111|NCT00244725|EG003|Reported Event|WARFARIN INR 2.0 TO 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
10842112|NCT00244751|BG000|Baseline|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842113|NCT00244751|BG001|Baseline|GI262570 0.5 mg|Participants received GI262570 0.5 mg. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842114|NCT00244751|BG002|Baseline|GI262570 1.0 mg|Participants received GI262570 1.0 mg once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842115|NCT00244751|BG003|Baseline|Total|Total of all reporting groups
10842116|NCT00244751|FG000|Participant Flow|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842117|NCT00244751|FG001|Participant Flow|GI262570 0.5 mg|Participants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842118|NCT00244751|FG002|Participant Flow|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842119|NCT00244751|OG000|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842120|NCT00244751|OG001|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842121|NCT00244751|OG002|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842122|NCT00244751|OG001|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842123|NCT00244751|OG002|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842124|NCT00244751|OG002|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842125|NCT00244751|OG000|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842126|NCT00244751|OG001|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842127|NCT00244751|OG002|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842128|NCT00244751|OG003|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842129|NCT00244751|OG000|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842130|NCT00244751|OG002|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842131|NCT00244751|EG000|Reported Event|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842132|NCT00244751|EG001|Reported Event|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842133|NCT00244751|EG002|Reported Event|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
10842134|NCT00244764|BG000|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
10842135|NCT00244764|FG000|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
10842136|NCT00244764|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
10842137|NCT00244764|OG000|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
11331056|NCT03473886|OG000|Outcome|Intervention Arm: PP-MI|"Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program.~Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability."
11331057|NCT03473886|EG000|Reported Event|Intervention Arm: PP-MI|"Participants will complete an 8-week group physical activity and positive psychology program, in which they will complete exercises related to increasing positive emotions and physical activity during and between the group sessions. They will track their activity (steps) and set personalized physical activity goals each week, as they complete a group walk or indoor exercise during the group sessions. We will ask questions about participants' health and health behaviors, and ask them to wear a physical activity monitor at the beginning and end of the program.~Intervention arm: PP-MI: The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walk-ability."
11331058|NCT03474081|BG000|Baseline|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
11331059|NCT03474081|BG001|Baseline|Tiotropium 18 mcg|Participants received tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via MDI during conduct of the study, if required.
11331060|NCT03474081|BG002|Baseline|Total|Total of all reporting groups
11331061|NCT03474081|FG000|Participant Flow|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
11331062|NCT03474081|FG001|Participant Flow|Tiotropium 18 mcg|Participants received tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via MDI during conduct of the study, if required.
11331063|NCT03474081|OG000|Outcome|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
11331064|NCT03474081|OG001|Outcome|Tiotropium 18 mcg|Participants received tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via MDI during conduct of the study, if required.
11331065|NCT03474081|EG000|Reported Event|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
11331066|NCT03474081|EG001|Reported Event|Tiotropium 18 mcg|Participants received tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via MDI during conduct of the study, if required.
11331067|NCT03474172|BG000|Baseline|Real Tuina|"Children will receive real tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.~Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a real Tuina will be manipulated."
11331068|NCT03474172|BG001|Baseline|Sham Tuina|"Except for the conventional therapy given by doctors, children in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed by parents, observers and children who are equal or older than 3 years old.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331069|NCT03474172|BG002|Baseline|Total|Total of all reporting groups
11335778|NCT03556761|BG000|Baseline|Oral Furosemide|Oral tablet of furosemide 20 mg once daily for a total of 5 consecutive doses.
10842138|NCT00244764|EG000|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
11331070|NCT03474172|FG000|Participant Flow|Real Tuina|"Children will receive real tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.~Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a real Tuina will be manipulated."
11331071|NCT03474172|FG001|Participant Flow|Sham Tuina|"Except for the conventional therapy given by doctors, children in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed by parents and observers.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331072|NCT03474172|OG000|Outcome|Real Tuina|"Participants will receive real tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.~Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a real Tuina will be manipulated."
11331073|NCT03474172|OG001|Outcome|Sham Tuina|"Participants in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331074|NCT03474172|OG000|Outcome|Real Tuina|"Children will receive real tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.~Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a real Tuina will be manipulated."
11331075|NCT03474172|OG001|Outcome|Sham Tuina|"Except for the conventional therapy given by doctors, children in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed by parents, observers and children who are equal or older than 3 years old.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331076|NCT03474172|OG001|Outcome|Sham Tuina|"Except for the conventional therapy given by doctors, children in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed by parents and observers.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331077|NCT03474172|EG000|Reported Event|Real Tuina|"Children will receive real tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.~Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a real Tuina will be manipulated."
11335779|NCT03556761|BG001|Baseline|Placebo Oral Tablet|Oral tablet of placebo once daily for a total of 5 consecutive doses.
11335780|NCT03556761|BG002|Baseline|Total|Total of all reporting groups
11335781|NCT03556761|FG000|Participant Flow|Oral Furosemide|"Oral furosemide 20 mg/day for a total of 5 consecutive doses.~Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily"
11331078|NCT03474172|EG001|Reported Event|Sham Tuina|"Except for the conventional therapy given by doctors, children in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed.~Cloak Shape Device for Sham Tuina: The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated"
11331079|NCT03474406|BG000|Baseline|Cancer Patients|Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires.
11331080|NCT03474406|FG000|Participant Flow|Cancer Patients|Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires.
11331081|NCT03474406|OG000|Outcome|Cancer Patients|Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires.
11331082|NCT03474406|EG000|Reported Event|Cancer Patients|Cancer patients 18 years and older who received a new consult for cancer pain at the Siriraj Pain Clinic from January to December 2018. Written informed consent was obtained from all patients. We excluded patients who had difficulties with listening, reading, and writing Thai and those who were unable to interpret the evaluation form/questionnaires.
11331083|NCT03474874|BG000|Baseline|Collagen Dressing and Comparator|"NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.~NeoMatriX Collagen Dressing: Collagen wound dressing"
11331084|NCT03474874|FG000|Participant Flow|Collagen Dressing and Comparator|"NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.~NeoMatriX Collagen Dressing: Collagen wound dressing"
11331085|NCT03474874|OG000|Outcome|NeoMatriX|NeoMatriX Collagen Dressing: Collagen wound dressing
11331086|NCT03474874|OG001|Outcome|Positive Control|0.4% SLS on absorbent pad of occlusive dressing
11331087|NCT03474874|OG002|Outcome|Negative Control|Normal saline on absorbent pad of occlusive dressing
11331088|NCT03474874|EG000|Reported Event|Collagen Dressing and Comparator|"NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.~NeoMatriX Collagen Dressing: Collagen wound dressing"
11331089|NCT03475056|BG000|Baseline|Group 1: cAd3-Marburg Vaccine (1x10^10 PU)|"cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331090|NCT03475056|BG001|Baseline|Group 2: cAd3-Marburg Vaccine (1x10^11 PU)|"cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331091|NCT03475056|BG002|Baseline|Total|Total of all reporting groups
11331092|NCT03475056|FG000|Participant Flow|Group 1: cAd3-Marburg Vaccine (1x10^10 PU)|"cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331093|NCT03475056|FG001|Participant Flow|Group 2: cAd3-Marburg Vaccine (1x10^11 PU)|"cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331094|NCT03475056|OG000|Outcome|Group 1: cAd3-Marburg Vaccine (1x10^10 PU)|"cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331095|NCT03475056|OG001|Outcome|Group 2: cAd3-Marburg Vaccine (1x10^11 PU)|"cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331096|NCT03475056|OG002|Outcome|Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)|Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
11331097|NCT03475056|EG000|Reported Event|Group 1: cAd3-Marburg Vaccine (1x10^10 PU)|"cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331098|NCT03475056|EG001|Reported Event|Group 2: cAd3-Marburg Vaccine (1x10^11 PU)|"cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL~cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP)."
11331099|NCT03475316|BG000|Baseline|Social Dancing|"The program includes Fox-trot, Waltz, and Latin dances.~Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down."
10842139|NCT00244855|BG000|Baseline|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842140|NCT00244855|BG001|Baseline|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842141|NCT00244855|BG002|Baseline|Total|Total of all reporting groups
10842142|NCT00244855|FG000|Participant Flow|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842143|NCT00244855|FG001|Participant Flow|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842144|NCT00244855|OG000|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842145|NCT00244855|OG001|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842146|NCT00244855|OG000|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842147|NCT00244855|OG001|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842148|NCT00244855|EG000|Reported Event|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842149|NCT00244855|EG001|Reported Event|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
10842150|NCT00244881|BG000|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10842151|NCT00244881|FG000|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10842152|NCT00244881|OG000|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10842153|NCT00244881|EG000|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
10842154|NCT00244933|BG000|Baseline|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
10842155|NCT00244933|FG000|Participant Flow|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
10842156|NCT00244933|OG000|Outcome|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
10842157|NCT00244933|EG000|Reported Event|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
10842158|NCT00244985|BG000|Baseline|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
10842159|NCT00244985|FG000|Participant Flow|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
11335782|NCT03556761|FG001|Participant Flow|Placebo Oral Tablet|"Placebo once per day for a total of 5 consecutive doses.~Placebo Oral Tablet: Placebo, PO, daily"
11331100|NCT03475316|BG001|Baseline|Treadmill Walking|"The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.~Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group)."
11331101|NCT03475316|BG002|Baseline|Total|Total of all reporting groups
11331102|NCT03475316|FG000|Participant Flow|Social Dancing|"The program includes Fox-trot, Waltz, and Latin dances.~Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down."
11331103|NCT03475316|FG001|Participant Flow|Treadmill Walking|"The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.~Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group)."
11331104|NCT03475316|OG000|Outcome|Social Dancing|"The program includes Fox-trot, Waltz, and Latin dances.~Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down."
11331105|NCT03475316|OG001|Outcome|Treadmill Walking|"The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.~Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group)."
11331106|NCT03475316|EG000|Reported Event|Social Dancing|"The program includes Fox-trot, Waltz, and Latin dances.~Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down."
11331107|NCT03475316|EG001|Reported Event|Treadmill Walking|"The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.~Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group)."
11331108|NCT03475875|BG000|Baseline|Dispensed Subjects|All subjects dispensed at least one study lens.
11331109|NCT03475875|FG000|Participant Flow|Test/Control/Control|Subjects that wore the Test lens during the first period, the Control lens during the second period and the Control lens again in the third period.
11331110|NCT03475875|FG001|Participant Flow|Control/Test/Test|Subjects that wore the Control lens during the first period, the Test lens during the second period and the Test lens again in the third period.
11331111|NCT03475875|OG000|Outcome|Test|Subjects that wore the Test lens during any of the three study periods.
11331112|NCT03475875|OG001|Outcome|Control|Subjects that wore the Control lens during any of the three study periods.
11331113|NCT03475875|EG000|Reported Event|Test|Subjects that wore the Test lens during any of the three study periods.
11331114|NCT03475875|EG001|Reported Event|Control|Subjects that wore the Control lens during any of the three study periods.
11331115|NCT03475992|BG000|Baseline|Pre-diagnosed Breast Cancer - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331116|NCT03475992|BG001|Baseline|Pre-diagnosed Breast Cyst|"Low-power microwave breast imaging system.~No prior biopsy~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331117|NCT03475992|BG002|Baseline|Pre-diagnosed Benign Lesion - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331118|NCT03475992|BG003|Baseline|Total|Total of all reporting groups
11331119|NCT03475992|FG000|Participant Flow|Pre-diagnosed Breast Cancer - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331120|NCT03475992|FG001|Participant Flow|Pre-diagnosed Breast Cyst|"Low-power microwave breast imaging system.~No prior biopsy~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331121|NCT03475992|FG002|Participant Flow|Pre-diagnosed Benign Lesion - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331122|NCT03475992|OG000|Outcome|Pre-diagnosed Breast Cancer - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331123|NCT03475992|OG001|Outcome|Pre-diagnosed Breast Cyst|"Low-power microwave breast imaging system.~No prior biopsy~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331124|NCT03475992|OG002|Outcome|Pre-diagnosed Benign Lesion - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11335783|NCT03556761|OG000|Outcome|Oral Furosemide|"Oral furosemide 20 mg/day for a total of 5 consecutive doses.~Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily"
10842160|NCT00244985|OG000|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
10842161|NCT00244985|EG000|Reported Event|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
10842162|NCT00245011|BG000|Baseline|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.~Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.~Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later."
10842163|NCT00245011|FG000|Participant Flow|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.~Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion."
10842164|NCT00245011|OG000|Outcome|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. ^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of ^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.~filgrastim: Filgrastim is administered every day til count recovery.~ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.~peripheral blood stem cell harvesting: completed before administration of ^153Sm-EDTMP, collection of autologous hematopoietic stem cells.~radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of ^153Sm-EDTMP.~^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later."
10842165|NCT00245011|EG000|Reported Event|Samarium-153|"Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.~filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.~ifosfamide: Ifosfamide administered IV.~peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered~Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection~sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation."
10842965|NCT00251004|BG000|Baseline|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
10842966|NCT00251004|BG001|Baseline|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
10842967|NCT00251004|BG002|Baseline|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
10842968|NCT00251004|BG003|Baseline|Total|Total of all reporting groups
10842969|NCT00251004|FG000|Participant Flow|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
10848224|NCT00289185|BG000|Baseline|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10842166|NCT00245037|BG000|Baseline|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
10842167|NCT00245037|FG000|Participant Flow|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
10842168|NCT00245037|OG000|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
10842169|NCT00245037|EG000|Reported Event|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
10842170|NCT00245050|BG000|Baseline|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
10842171|NCT00245050|BG001|Baseline|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
10842172|NCT00245050|BG002|Baseline|Total|Total of all reporting groups
10842173|NCT00245050|FG000|Participant Flow|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
10842174|NCT00245050|FG001|Participant Flow|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
10842175|NCT00245050|OG000|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
10842176|NCT00245050|OG001|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
10842177|NCT00245050|EG000|Reported Event|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
10842178|NCT00245050|EG001|Reported Event|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
10842179|NCT00245063|BG000|Baseline|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
10842180|NCT00245063|BG001|Baseline|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
10842181|NCT00245063|BG002|Baseline|Total|Total of all reporting groups
10842182|NCT00245063|FG000|Participant Flow|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
10842183|NCT00245063|FG001|Participant Flow|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
10842184|NCT00245063|OG000|Outcome|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
10842185|NCT00245063|OG001|Outcome|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
11331125|NCT03475992|EG000|Reported Event|Pre-diagnosed Breast Cancer - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331126|NCT03475992|EG001|Reported Event|Pre-diagnosed Breast Cyst|"Low-power microwave breast imaging system.~No prior biopsy~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331127|NCT03475992|EG002|Reported Event|Pre-diagnosed Benign Lesion - Biopsy Confirmed|"Low-power microwave breast imaging system.~Core needle biopsy performed ≥14 days before the microwave breast investigation~Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump"
11331128|NCT03476278|BG000|Baseline|Regional|"patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331129|NCT03476278|FG000|Participant Flow|Regional|"patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331130|NCT03476278|OG000|Outcome|Satisfaction|"satisfied patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331131|NCT03476278|OG001|Outcome|Dissatisfaction|"dissatisfied patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331132|NCT03476278|OG000|Outcome|Safe|Patients who feel safe under regional anesthesia
11331133|NCT03476278|OG001|Outcome|Unsafe|Patients who feel unsafe under regional anesthesia
11331134|NCT03476278|OG002|Outcome|Comfortable|Patients who feel comfortable under regional anesthesia
11331135|NCT03476278|OG003|Outcome|Excited|Patients who feel excited under regional anesthesia
11331136|NCT03476278|OG004|Outcome|Anxious|Patients who feel anxious under regional anesthesia
11331137|NCT03476278|OG000|Outcome|Satisfaction|"patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331138|NCT03476278|OG001|Outcome|Dissatisfaction|"patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331139|NCT03476278|OG000|Outcome|Satisfaction|"satisfied patients who underwent surgery under regional anesthesia.~Patients were only able to mark one option: satisfied or dissatisfied."
11331140|NCT03476278|OG001|Outcome|Dissatisfaction|"dissatisfied patients who underwent surgery under regional anesthesia.~Patients were only able to mark one option: satisfied or dissatisfied."
11331141|NCT03476278|EG000|Reported Event|Regional, Questionnaire|"patients who underwent surgery under regional anesthesia.~Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period"
11331142|NCT03476798|BG000|Baseline|Bevacizumab + Rucaparib|"Rucaparib: Rucaparib 600mg PO BID daily~Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle"
11331143|NCT03476798|FG000|Participant Flow|Bevacizumab + Rucaparib|"Rucaparib: Rucaparib 600mg PO BID daily~Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle"
11331144|NCT03476798|OG000|Outcome|Bevacizumab + Rucaparib|"Rucaparib: Rucaparib 600mg PO BID daily~Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle"
11331145|NCT03476798|EG000|Reported Event|Bevacizumab + Rucaparib|"Rucaparib: Rucaparib 600mg PO BID daily~Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle"
11331146|NCT03476850|BG000|Baseline|QL Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331147|NCT03476850|BG001|Baseline|TAP Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331148|NCT03476850|BG002|Baseline|Total|Total of all reporting groups
11331149|NCT03476850|FG000|Participant Flow|QL Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331150|NCT03476850|FG001|Participant Flow|TAP Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331151|NCT03476850|OG000|Outcome|QL Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331152|NCT03476850|OG001|Outcome|TAP Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11335784|NCT03556761|OG001|Outcome|Placebo Oral Tablet|"Placebo once per day for a total of 5 consecutive doses.~Placebo Oral Tablet: Placebo, PO, daily"
11331153|NCT03476850|EG000|Reported Event|QL Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331154|NCT03476850|EG001|Reported Event|TAP Block|"Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.~TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc."
11331155|NCT03477006|BG000|Baseline|LTLR-WB|"Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care~Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood"
11331156|NCT03477006|BG001|Baseline|Standard Care|Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
11331157|NCT03477006|BG002|Baseline|Total|Total of all reporting groups
11331158|NCT03477006|FG000|Participant Flow|LTLR-WB|"Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care~Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood"
11331159|NCT03477006|FG001|Participant Flow|Standard Care|Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
11331160|NCT03477006|OG000|Outcome|LTLR-WB|"Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care~Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood"
11331161|NCT03477006|OG001|Outcome|Standard Care|Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
11331162|NCT03477006|EG000|Reported Event|LTLR-WB|"Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care~Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood"
11331163|NCT03477006|EG001|Reported Event|Standard Care|Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
11331164|NCT03477279|BG000|Baseline|Individual (HIV+ Women)|HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.
11331165|NCT03477279|BG001|Baseline|Couple (HIV+ Women)|HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
11331166|NCT03477279|BG002|Baseline|Male Partners of Women in Individual|These men will have access to standard of care procedures.
11331167|NCT03477279|BG003|Baseline|Male Partners of Women in Couple|These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.
11331168|NCT03477279|BG004|Baseline|Control Population (HIV- Women)|HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
11331169|NCT03477279|BG005|Baseline|Total|Total of all reporting groups
11331170|NCT03477279|FG000|Participant Flow|Individual (HIV+ Women)|HIV-infected pregnant women enrolled in the individual arm of the study will receive Standard of Care Option B+ procedures.
11331171|NCT03477279|FG001|Participant Flow|Couple (HIV+ Women)|These women will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
11331172|NCT03477279|FG002|Participant Flow|Male Partners of Women in Individual|These men will have access to standard of care procedures.
11331173|NCT03477279|FG003|Participant Flow|Male Partners of Women in Couple|These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.
11331174|NCT03477279|FG004|Participant Flow|Control Population (HIV- Women)|HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
11331175|NCT03477279|OG000|Outcome|Individual (HIV+ Women)|HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.
11331176|NCT03477279|OG001|Outcome|Couple (HIV+ Women)|HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
11331177|NCT03477279|OG000|Outcome|Male Partners of Women in Individual|These men will have access to standard of care procedures.
11331178|NCT03477279|OG001|Outcome|Male Partners of Women in Couple|These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.
11331179|NCT03477279|OG000|Outcome|Individual and Couple HIV-positive Women|A subset of HIV-positive pregnant women enrolled in the individual arm and couple arms of the study with recently acquired HIV infection
11331180|NCT03477279|OG001|Outcome|Control Population (HIV- Women)|HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
11331181|NCT03477279|EG000|Reported Event|Individual (HIV+ Women)|HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.
11335785|NCT03556761|EG000|Reported Event|Oral Furosemide|"Oral furosemide 20 mg/day for a total of 5 consecutive doses.~Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily"
11331182|NCT03477279|EG001|Reported Event|Couple (HIV+ Women)|HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
11331183|NCT03477279|EG002|Reported Event|Male Partners of Women in Individual|These men will have access to standard of care procedures.
11331184|NCT03477279|EG003|Reported Event|Male Partners of Women in Couple|These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.
11331185|NCT03477279|EG004|Reported Event|Control Population (HIV- Women)|HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
11331186|NCT03477838|BG000|Baseline|CGM Intervention Arm|"Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.~FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days"
11331187|NCT03477838|FG000|Participant Flow|CGM Intervention Arm|"Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.~FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days"
11331188|NCT03477838|OG000|Outcome|CGM Intervention Arm|"Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.~FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days"
11331189|NCT03477838|EG000|Reported Event|CGM Intervention Arm|"Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.~FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days"
11331190|NCT03478163|BG000|Baseline|Control|The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
11331191|NCT03478163|BG001|Baseline|Antibiotics|"The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.~CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses~Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses"
11331192|NCT03478163|BG002|Baseline|Total|Total of all reporting groups
11331193|NCT03478163|FG000|Participant Flow|Control|The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
11331194|NCT03478163|FG001|Participant Flow|Antibiotics|"The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.~CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses~Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses"
11331195|NCT03478163|OG000|Outcome|Control|The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
11331196|NCT03478163|OG001|Outcome|Antibiotics|"The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.~CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses~Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses"
11331197|NCT03478163|EG000|Reported Event|Control|The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
11331198|NCT03478163|EG001|Reported Event|Antibiotics|"The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.~CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses~Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses"
11331199|NCT03478254|BG000|Baseline|Adherence Vaccination|"All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, pneumococcal and HBV vaccination status.~Influenza vaccination: Correct influenza vaccination status was considered in the following situation:~- Received at least one Influenza vaccine dose in the last year.~Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.~One PPSV 23 dose in the last 5 years.~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.~HBV vaccination: Correct HBV vaccination status was considered in the following situation:~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
11331200|NCT03478254|FG000|Participant Flow|Influenza Vaccination|"All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.~Influenza vaccination: Correct influenza vaccination status was considered in the following situation:~- Received at least one Influenza vaccine dose in the last year.~Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.~One PPSV 23 dose in the last 5 years.~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.~HBV vaccination: Correct HBV vaccination status was considered in the following situation:~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
11331201|NCT03478254|OG000|Outcome|Adherece Vaccination|"All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.~Influenza vaccination: Correct influenza vaccination status was considered in the following situation:~- Received at least one Influenza vaccine dose in the last year.~Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.~One PPSV 23 dose in the last 5 years.~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.~HBV vaccination: Correct HBV vaccination status was considered in the following situation:~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
11331202|NCT03478254|OG000|Outcome|Vaccination Adherence|"All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.~Influenza vaccination: Correct influenza vaccination status was considered in the following situation:~- Received at least one Influenza vaccine dose in the last year.~Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.~One PPSV 23 dose in the last 5 years.~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.~Hepatitis B Virus (HBV) vaccination: Correct Hepatitis B Virus (HBV) vaccination status was considered in the following situation:~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
11331203|NCT03478254|EG000|Reported Event|Adherence Vaccination|"All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status.~Influenza vaccination: Correct influenza vaccination status was considered in the following situation:~- Received at least one Influenza vaccine dose in the last year.~Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.~One PPSV 23 dose in the last 5 years.~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.~HBV vaccination: Correct HBV vaccination status was considered in the following situation:~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
11331204|NCT03478371|BG000|Baseline|Overall Study|This was a single center, double-blind 4 treatment, 4 period cross-over design. Each participant received each test product for one menstrual cycle.
11331205|NCT03478371|FG000|Participant Flow|Overall Study|This was a single center, double-blind 4 treatment, 4 period cross-over design. Each participant received each test product for one menstrual cycle.
11331206|NCT03478371|OG000|Outcome|Marketed Tampon D|"Regular absorbency tampon~tampon D: regular absorbency tampon"
11331207|NCT03478371|OG001|Outcome|Marketed Tampon M|"Regular absorbency tampon~tampon M: regular absorbency tampon"
11331208|NCT03478371|OG002|Outcome|Marketed Tampon T|"Regular absorbency tampon~tampon T: regular absorbency tampon"
11331209|NCT03478371|OG003|Outcome|Marketed Tampon V|"Regular absorbency tampon~tampon V: regular absorbency tampon"
11331210|NCT03478371|EG000|Reported Event|Marketed Tampon D|"Regular absorbency tampon~tampon D: regular absorbency tampon"
11331211|NCT03478371|EG001|Reported Event|Marketed Tampon M|"Regular absorbency tampon~tampon M: regular absorbency tampon"
11331212|NCT03478371|EG002|Reported Event|Marketed Tampon T|"Regular absorbency tampon~tampon T: regular absorbency tampon"
11331213|NCT03478371|EG003|Reported Event|Marketed Tampon V|"Regular absorbency tampon~tampon V: regular absorbency tampon"
11331214|NCT03478644|BG000|Baseline|Experimental Denture Wipe|All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
11331215|NCT03478644|BG001|Baseline|Water Rinse|All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
11331216|NCT03478644|BG002|Baseline|Total|Total of all reporting groups
11331217|NCT03478644|FG000|Participant Flow|Experimental Denture Wipe|All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
11331218|NCT03478644|FG001|Participant Flow|Water Rinse|All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
11331219|NCT03478644|OG000|Outcome|Experimental Denture Wipe|Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
11331220|NCT03478644|OG001|Outcome|Water Rinse|Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
11331221|NCT03478644|EG000|Reported Event|Experimental Denture Wipe|Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
11331222|NCT03478644|EG001|Reported Event|Water Rinse|Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
11331223|NCT03478657|BG000|Baseline|Stratum 1: 5-7 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA dry powder inhaler (DPI) for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI.
11331224|NCT03478657|BG001|Baseline|Stratum 2: 8-11 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI
11331225|NCT03478657|BG002|Baseline|Total|Total of all reporting groups
11331226|NCT03478657|FG000|Participant Flow|Stratum 1: 5-7 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA dry powder inhaler (DPI) for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI.
11335786|NCT03556761|EG001|Reported Event|Placebo Oral Tablet|"Placebo once per day for a total of 5 consecutive doses.~Placebo Oral Tablet: Placebo, PO, daily"
11331227|NCT03478657|FG001|Participant Flow|Stratum 2: 8-11 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI
11331228|NCT03478657|OG000|Outcome|Stratum 1: 5-7 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA dry powder inhaler (DPI) for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI.
11331229|NCT03478657|OG001|Outcome|Stratum 2: 8-11 Years|Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI
11331230|NCT03478657|OG000|Outcome|Stratum 1 + Stratum 2|All participants from Stratum 1 and Stratum 2 (5 to 11 years) were included.
11331231|NCT03478657|EG000|Reported Event|Stratum 1 + Stratum 2|All participants from Stratum 1 and Stratum 2 (5 to 11 years) were included.
11331232|NCT03478683|BG000|Baseline|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331233|NCT03478683|BG001|Baseline|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331234|NCT03478683|BG002|Baseline|Total|Total of all reporting groups
11331235|NCT03478683|FG000|Participant Flow|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331236|NCT03478683|FG001|Participant Flow|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331237|NCT03478683|OG000|Outcome|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331238|NCT03478683|OG001|Outcome|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331239|NCT03478683|EG000|Reported Event|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331240|NCT03478683|EG001|Reported Event|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331241|NCT03478696|BG000|Baseline|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331242|NCT03478696|BG001|Baseline|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331243|NCT03478696|BG002|Baseline|Total|Total of all reporting groups
11335787|NCT03556891|BG000|Baseline|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
11335788|NCT03556891|FG000|Participant Flow|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
11331244|NCT03478696|FG000|Participant Flow|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331245|NCT03478696|FG001|Participant Flow|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331246|NCT03478696|OG000|Outcome|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331247|NCT03478696|OG001|Outcome|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331248|NCT03478696|EG000|Reported Event|Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg|Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331249|NCT03478696|EG001|Reported Event|Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg|Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
11331250|NCT03478787|BG000|Baseline|Secukinumab|Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
11331251|NCT03478787|BG001|Baseline|Risankizumab|Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
11331252|NCT03478787|BG002|Baseline|Total|Total of all reporting groups
11331253|NCT03478787|FG000|Participant Flow|Secukinumab|Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
11331254|NCT03478787|FG001|Participant Flow|Risankizumab|Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
11331255|NCT03478787|OG000|Outcome|Secukinumab|Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
11331256|NCT03478787|OG001|Outcome|Risankizumab|Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
11331257|NCT03478787|EG000|Reported Event|Secukinumab|Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.
11331258|NCT03478787|EG001|Reported Event|Risankizumab|Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug .
11331259|NCT03478891|BG000|Baseline|Group 1: 5 mg/kg IV|"Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331260|NCT03478891|BG001|Baseline|Group 2: 25 mg/kg IV|"Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331261|NCT03478891|BG002|Baseline|Group 3: 50 mg/kg IV|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331262|NCT03478891|BG003|Baseline|Total|Total of all reporting groups
11331263|NCT03478891|FG000|Participant Flow|Group 1: 5 mg/kg IV|"Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331264|NCT03478891|FG001|Participant Flow|Group 2: 25 mg/kg IV|"Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331265|NCT03478891|FG002|Participant Flow|Group 3: 50 mg/kg IV|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331266|NCT03478891|OG000|Outcome|Group 1: 5 mg/kg IV (n=3)|"Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331267|NCT03478891|OG001|Outcome|Group 2: 25 mg/kg IV (n=5)|"Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331268|NCT03478891|OG002|Outcome|Group 3: 50 mg/kg IV (n=10)|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331269|NCT03478891|OG003|Outcome|Overall (n=18)|Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
11331270|NCT03478891|OG002|Outcome|Group 3: 50 mg/kg IV (n=5)|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331271|NCT03478891|OG002|Outcome|Group 3: 50 mg/kg IV (n=1)|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331272|NCT03478891|OG003|Outcome|Overall (n=9)|Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
11331273|NCT03478891|EG000|Reported Event|Group 1: 5 mg/kg IV|"Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331274|NCT03478891|EG001|Reported Event|Group 2: 25 mg/kg IV|"Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331275|NCT03478891|EG002|Reported Event|Group 3: 50 mg/kg IV|"Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.~VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP)."
11331276|NCT03478904|BG000|Baseline|160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule|"Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)"
11331277|NCT03478904|FG000|Participant Flow|160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule|"Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)"
11331278|NCT03478904|OG000|Outcome|160mg Enzalutamide Liquid|Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)
11331279|NCT03478904|OG001|Outcome|4x40mg Enzalutamide Capsule|Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)
11331280|NCT03478904|OG000|Outcome|Grade 1|Grade 1 is mild.
11331281|NCT03478904|OG001|Outcome|Grade 2|Grade 2 is moderate.
11331282|NCT03478904|OG002|Outcome|Grade 3|Grade 3 is severe or medically significant but not life-threatening.
11331283|NCT03478904|OG003|Outcome|Grade 4|Grade 4 is life-threatening consequences.
11331284|NCT03478904|OG004|Outcome|Grade 5|Grade 5 is death related to adverse event.
11331285|NCT03478904|OG000|Outcome|160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule|"Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)"
11331286|NCT03478904|EG000|Reported Event|160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule|"Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)"
11331287|NCT03478969|BG000|Baseline|Group A: Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331288|NCT03478969|BG001|Baseline|Group B: MDI, Then Accu-Chek® Solo|Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331289|NCT03478969|BG002|Baseline|Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331290|NCT03478969|BG003|Baseline|Total|Total of all reporting groups
11335789|NCT03556891|OG000|Outcome|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
11331291|NCT03478969|FG000|Participant Flow|Group A: Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331292|NCT03478969|FG001|Participant Flow|Group B: MDI, Then Accu-Chek® Solo|Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331293|NCT03478969|FG002|Participant Flow|Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331294|NCT03478969|OG000|Outcome|Group A: Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331295|NCT03478969|OG001|Outcome|Group B: MDI, Then Accu-Chek® Solo|Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331296|NCT03478969|OG001|Outcome|Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331297|NCT03478969|OG002|Outcome|Group C: Mylife™ OmniPod®, Then Accu-Chek® Solo|Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
11331298|NCT03478969|EG000|Reported Event|Group A: Accu-Chek® Solo (Parallel Phase)|Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks.
11331299|NCT03478969|EG001|Reported Event|Group B: MDI (Parallel Phase)|Multiple daily injections (MDI) for 26 weeks.
11331300|NCT03478969|EG002|Reported Event|Group C: Mylife™ OmniPod® (Parallel Phase)|Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks.
11331301|NCT03478969|EG003|Reported Event|Group D: Groups A+B+C (Solo Phase)|From Week 26 until Week 39, all Groups (A, B and C) used the Accu-Chek® Solo Micropump system for CSII therapy.
11331302|NCT03478982|BG000|Baseline|Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331303|NCT03478982|BG001|Baseline|Double-blind: Placebo|Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331304|NCT03478982|BG002|Baseline|Double-blind: Staccato Alprazolam 1.0 mg|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331305|NCT03478982|BG003|Baseline|Double-blind: Staccato Alprazolam 2.0 mg|Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331306|NCT03478982|BG004|Baseline|Total Title|
11331307|NCT03478982|FG000|Participant Flow|Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331308|NCT03478982|FG001|Participant Flow|Double-blind: Placebo|Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331309|NCT03478982|FG002|Participant Flow|Double-blind: Staccato Alprazolam 1.0 mg|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331310|NCT03478982|FG003|Participant Flow|Double-blind: Staccato Alprazolam 2.0 mg|Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331311|NCT03478982|OG000|Outcome|Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331312|NCT03478982|OG001|Outcome|Double-blind: Placebo|Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331313|NCT03478982|OG002|Outcome|Double-blind: Staccato Alprazolam 1.0 mg|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331314|NCT03478982|OG003|Outcome|Double-blind: Staccato Alprazolam 2.0 mg|Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331315|NCT03478982|EG000|Reported Event|Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331316|NCT03478982|EG001|Reported Event|Double-blind: Placebo|Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11331317|NCT03478982|EG002|Reported Event|Double-blind: Staccato Alprazolam 1.0 mg|Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
10842186|NCT00245063|EG000|Reported Event|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
11331318|NCT03478982|EG003|Reported Event|Double-blind: Staccato Alprazolam 2.0 mg|Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
11333835|NCT03520387|OG003|Outcome|Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11333836|NCT03520387|EG000|Reported Event|Pre-Randomizaton Run-In Period|The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized. There are no participants in this group after randomization.
11333837|NCT03520387|EG001|Reported Event|Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11333838|NCT03520387|EG002|Reported Event|Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress."
11333839|NCT03520387|EG003|Reported Event|Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE|"Participants received both:~Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11333840|NCT03520387|EG004|Reported Event|Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE|"Participants received both:~Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.~and~Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook."
11333841|NCT03520400|BG000|Baseline|Exercise Intervention Group|"Group receives one year of exercise and lifestyle intervention~Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week."
11333842|NCT03520400|BG001|Baseline|PCI Group (Usual Care)|Group receives standard clinical care with no intervention
11333843|NCT03520400|BG002|Baseline|Total|Total of all reporting groups
11333844|NCT03520400|FG000|Participant Flow|Exercise Intervention Group|"Group receives one year of exercise and lifestyle intervention~Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week."
11333845|NCT03520400|FG001|Participant Flow|PCI Group (Usual Care)|Group receives standard clinical care with no intervention
11333846|NCT03520400|OG000|Outcome|Exercise Intervention Group|"Group receives one year of exercise and lifestyle intervention~Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week."
11333847|NCT03520400|OG001|Outcome|PCI Group (Usual Care)|Group receives standard clinical care with no intervention
11335790|NCT03556891|EG000|Reported Event|eCoin Tibial Nerve Stimulation|eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
10842187|NCT00245063|EG001|Reported Event|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
11331319|NCT03479216|BG000|Baseline|Precedex|"5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)~Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery."
11331320|NCT03479216|BG001|Baseline|Magnesium Sulfate|"5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)~Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery."
11331321|NCT03479216|BG002|Baseline|Total|Total of all reporting groups
11331322|NCT03479216|FG000|Participant Flow|Precedex|"5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)~Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery."
11331323|NCT03479216|FG001|Participant Flow|Magnesium Sulfate|"5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)~Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery."
11331324|NCT03479216|OG000|Outcome|Precedex|"5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)~Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery."
11331325|NCT03479216|OG001|Outcome|Magnesium Sulfate|"5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)~Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery."
11331326|NCT03479216|EG000|Reported Event|Precedex|"5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)~Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery."
11331327|NCT03479216|EG001|Reported Event|Magnesium Sulfate|"5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)~Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery."
11331328|NCT03479944|BG000|Baseline|All Study Subjects|Cataract extraction surgery with either FLACS or conventional technique allocated to each eye (within-subject), as randomized. Both eye surgeries occurred on the same day.
11331329|NCT03479944|FG000|Participant Flow|All Study Subjects|Cataract extraction surgery with either FLACS or conventional technique allocated to each eye (within-subject), as randomized. Both eye surgeries occurred on the same day.
11331330|NCT03479944|OG000|Outcome|FLACS|Femtosecond laser assisted cataract surgery (FLACS) with LenSx® and Centurion® Vision System in combination
11331331|NCT03479944|OG001|Outcome|Conventional|Manual cataract surgery with Centurion® Vision System
11331332|NCT03479944|OG000|Outcome|FLACS|Femtosecond laser assisted cataract surgery with LenSx® and Centurion® Vision System in combination
11331333|NCT03479944|EG000|Reported Event|Ocular Adverse Events - FLACS|All subjects/eyes for which cataract surgery was performed with FLACS (regardless of success or failure)
11331334|NCT03479944|EG001|Reported Event|Ocular Adverse Events - Conventional|All subjects/eyes for which cataract surgery was performed with Conventional technique (regardless of success or failure)
11331335|NCT03479944|EG002|Reported Event|Non-Ocular Adverse Events|All subjects for which cataract surgery was performed (regardless of success or failure)
11331336|NCT03480009|BG000|Baseline|Dextromethorphan, With Narcotic Prescription|Participants receiving dextromethorphan and a narcotic prescription
11331337|NCT03480009|BG001|Baseline|Placebo, With Narcotic Prescription|Participants receiving placebo and a narcotic prescription
11331338|NCT03480009|BG002|Baseline|Dextromethorphan, Declined Narcotic Prescription|Participants receiving dextromethorphan and declined a narcotic prescription
11331339|NCT03480009|BG003|Baseline|Placebo, Declined Narcotic Prescription|Participants receiving placebo and declined a narcotic prescription
11331340|NCT03480009|BG004|Baseline|Total|Total of all reporting groups
11331341|NCT03480009|FG000|Participant Flow|Dextromethorphan, Opted for Narcotic Prescription|"Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)~Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo."
11331342|NCT03480009|FG001|Participant Flow|Placebo, Opted for Narcotic Prescription|"Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)~Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo."
11331343|NCT03480009|FG002|Participant Flow|Dextromethorphan, Declined Narcotic Prescription|Dextromethorphan hydrobromide and patient declines narcotic
11331344|NCT03480009|FG003|Participant Flow|Placebo, Declined Narcotic Prescription|Avicel PH101 (Microcrystalline Cellulose NF) and patient declines narcotic
11331345|NCT03480009|OG000|Outcome|Dextromethorphan, Opted for Narcotic Prescription|Participants receiving dextromethorphan and opted for a narcotic prescription
11331346|NCT03480009|OG001|Outcome|Placebo, Opted for Narcotic Prescription|Participants receiving placebo and opted for a narcotic prescription
11331347|NCT03480009|OG002|Outcome|Dextromethorphan, Declined Narcotic Prescription|Participants receiving dextromethorphan and declined a narcotic prescription
11331348|NCT03480009|OG003|Outcome|Placebo, Declined Narcotic Prescription|Participants receiving placebo and declined a narcotic prescription
11331349|NCT03480009|OG000|Outcome|Dextromethorphan, Opted for Narcotic Prescription|Participants receiving dextromethorphan and opted for narcotic prescription
11331350|NCT03480009|OG001|Outcome|Placebo, Opted for Narcotic Prescription|Participants receiving placebo and opted for narcotic prescription
11331351|NCT03480009|OG002|Outcome|Dextromethorphan, Declined Narcotic Prescription|Participants receiving dextromethorphan and declined narcotic prescription
11331352|NCT03480009|EG000|Reported Event|Dextromethorphan, Opted for Narcotic Prescription|Participants receiving dextromethorphan and opted for a narcotic prescription
11331353|NCT03480009|EG001|Reported Event|Placebo, Opted for Narcotic Prescription|Participants receiving placebo and opted for a narcotic prescription
11331354|NCT03480009|EG002|Reported Event|Dextromethorphan, Declined Narcotic Prescription|Participants receiving dextromethorphan and declined a narcotic prescription
11331355|NCT03480009|EG003|Reported Event|Placebo, Declined Narcotic Prescription|Participants receiving placebo and declined a narcotic prescription
11331356|NCT03480022|BG000|Baseline|Liraglutide Pen Injector (Saxenda)|"Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily~Liraglutide Pen Injector [Saxenda]: daily sc injection of liraglutide with final dose of 3mg daily"
11331357|NCT03480022|BG001|Baseline|Placebo Liraglutide Pen Injector|"Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily~Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo"
11331358|NCT03480022|BG002|Baseline|Total|Total of all reporting groups
11331359|NCT03480022|FG000|Participant Flow|Liraglutide Pen Injector (Saxenda)|"Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily~Liraglutide Pen Injector [Saxenda]: daily sc injection of liraglutide with final dose of 3mg daily"
11331360|NCT03480022|FG001|Participant Flow|Placebo Liraglutide Pen Injector|"Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily~Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo"
11331361|NCT03480022|OG000|Outcome|Liraglutide Pen Injector (Saxenda)|"Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily~Liraglutide Pen Injector [Saxenda]: daily sc injection of liraglutide with final dose of 3mg daily"
11331362|NCT03480022|OG001|Outcome|Placebo Liraglutide Pen Injector|"Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily~Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo"
11331363|NCT03480022|EG000|Reported Event|Liraglutide Pen Injector (Saxenda)|"Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily~Liraglutide Pen Injector [Saxenda]: daily sc injection of liraglutide with final dose of 3mg daily"
11331364|NCT03480022|EG001|Reported Event|Placebo Liraglutide Pen Injector|"Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily~Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo"
11331365|NCT03480048|BG000|Baseline|Breastfeeding and Weight Loss Support|"Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.~Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss."
11331366|NCT03480048|BG001|Baseline|Usual Care|Participants receive usual care from their prenatal care provider.
11331367|NCT03480048|BG002|Baseline|Total|Total of all reporting groups
11331368|NCT03480048|FG000|Participant Flow|Breastfeeding and Weight Loss Support|"Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.~Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss."
11331369|NCT03480048|FG001|Participant Flow|Usual Care|Participants receive usual care from their prenatal care provider.
11331370|NCT03480048|OG000|Outcome|Breastfeeding and Weight Loss Support|"Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.~Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss."
11331371|NCT03480048|OG001|Outcome|Usual Care|Participants receive usual care from their prenatal care provider.
11331372|NCT03480048|EG000|Reported Event|Breastfeeding and Weight Loss Support|"Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.~Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss."
11331373|NCT03480048|EG001|Reported Event|Usual Care|Participants receive usual care from their prenatal care provider.
11331374|NCT03480152|BG000|Baseline|Cohort 1, Arm 1, Phase I - Dose Level 2 - 0.13mg|Gastrointestinal cancer patients receive 0.13mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331375|NCT03480152|BG001|Baseline|Cohort 1, Arm 1, Phase I - Dose Level 3 - 0.39mg|Gastrointestinal cancer patients receive 0.39mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331376|NCT03480152|BG002|Baseline|Total|Total of all reporting groups
11331377|NCT03480152|FG000|Participant Flow|Cohort 1, Arm 1, Phase I - Dose Level 2 - 0.13mg|Gastrointestinal cancer patients receive 0.13mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331378|NCT03480152|FG001|Participant Flow|Cohort 1, Arm 1, Phase I - Dose Level 3 - 0.39mg|Gastrointestinal cancer patients receive 0.39mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331379|NCT03480152|FG002|Participant Flow|Cohort 2a/2b, Arm 2, Phase II Maximum Tolerated Dose|(2a) Melanoma and (2b) Gastrointestinal or Genitourinary cancer patients receive the maximum tolerated dose (MTD) of messenger ribonucleic acid (mRNA) vaccine established in Phase I.
10842188|NCT00245102|BG000|Baseline|Angiosarcoma|Sorafenib 400 mg PO BID
10842189|NCT00245102|BG001|Baseline|MPNST|Sorafenib 400 mg PO BID
10842190|NCT00245102|BG002|Baseline|Leiomyosarcoma|Sorafenib 400 mg PO BID
10842191|NCT00245102|BG003|Baseline|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
10842192|NCT00245102|BG004|Baseline|Fibrosarcoma|Sorafenib 400 mg PO BID
10842193|NCT00245102|BG005|Baseline|Other Histology|Sorafenib 400 mg PO BID
10842194|NCT00245102|BG006|Baseline|Total|Total of all reporting groups
10842195|NCT00245102|FG000|Participant Flow|Angiosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842196|NCT00245102|FG001|Participant Flow|MPNST|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842197|NCT00245102|FG002|Participant Flow|Leiomyosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842198|NCT00245102|FG003|Participant Flow|Undifferentiated Pleomorphic Sarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842199|NCT00245102|FG004|Participant Flow|Fibrosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842200|NCT00245102|FG005|Participant Flow|Other Histology|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
10842201|NCT00245102|OG000|Outcome|Angiosarcoma|Sorafenib 400 mg PO BID
10842202|NCT00245102|OG001|Outcome|MPNST|Sorafenib 400 mg PO BID
10842203|NCT00245102|OG002|Outcome|Leiomyosarcoma|Sorafenib 400 mg PO BID
10842204|NCT00245102|OG003|Outcome|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
10842205|NCT00245102|OG004|Outcome|Fibrosarcoma|Sorafenib 400 mg PO BID
10842206|NCT00245102|OG005|Outcome|Other Histology|Sorafenib 400 mg PO BID
10842207|NCT00245102|EG000|Reported Event|Angiosarcoma|Sorafenib 400 mg PO BID
10842208|NCT00245102|EG001|Reported Event|MPNST|Sorafenib 400 mg PO BID
10842209|NCT00245102|EG002|Reported Event|Leiomyosarcoma|Sorafenib 400 mg PO BID
10842210|NCT00245102|EG003|Reported Event|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
10842211|NCT00245102|EG004|Reported Event|Fibrosarcoma|Sorafenib 400 mg PO BID
10842212|NCT00245102|EG005|Reported Event|Other Histology|Sorafenib 400 mg PO BID
10842213|NCT00245219|BG000|Baseline|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
10842214|NCT00245219|BG001|Baseline|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
10842215|NCT00245219|BG002|Baseline|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
10842216|NCT00245219|BG003|Baseline|Total|Total of all reporting groups
10842217|NCT00245219|FG000|Participant Flow|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
10842218|NCT00245219|FG001|Participant Flow|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
10842219|NCT00245219|FG002|Participant Flow|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
10842220|NCT00245219|OG000|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
10842221|NCT00245219|OG001|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
10842970|NCT00251004|FG001|Participant Flow|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11331380|NCT03480152|OG000|Outcome|Cohort 1, Arm 1, Phase I - Dose Level 2 - 0.13mg|Gastrointestinal cancer patients receive 0.13mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331381|NCT03480152|OG001|Outcome|Cohort 1, Arm 1, Phase I - Dose Level 3 - 0.39mg|Gastrointestinal cancer patients receive 0.39mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331382|NCT03480152|OG000|Outcome|Cohort 1, Arm 1, Phase I - Dose Level 2 - 0.13mg Starting Dose|Gastrointestinal Cancer patients receive 0.13mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331383|NCT03480152|OG001|Outcome|Cohort 1, Arm 1, Phase I - Dose Level 3 - 0.39mg|Gastrointestinal cancer patients receive 0.39mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular injections (IM) on Days 0, 14, 28, and 42.
11331384|NCT03480152|EG000|Reported Event|Cohort 1, Arm 1, Phase I - Dose Level 2 - 0.13mg|Gastrointestinal cancer patients receive 0.13mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331385|NCT03480152|EG001|Reported Event|Cohort 1, Arm 1, Phase I - Dose Level 3 - 0.39mg|Gastrointestinal cancer patients receive 0.39mg of messenger ribonucleic acid (mRNA) vaccine as intramuscular (IM) injections on Days 0, 14, 28, and 42.
11331386|NCT03480243|BG000|Baseline|Padsevonil and/or Erythromycin|"The study participants received treatment as follows:~Treatment Period 1: From Day 1 to Day 11:~Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4~Padsevonil 100 mg single dose on Day 5~1 week of wash-out (from evening of Day 5 to Day 11).~Treatment Period 2: From Day 12 to Day 22:~Padsevonil 100 mg bid on Day 12 to Day 15~Padsevonil 100 mg single dose on Day 16~1 week of wash-out (from evening of Day 16 to Day 22). Treatment Period 3: From Day 23 to 37~Treatment Period 3a:~-Erythromycin 500 mg bid on Day 23 to Day 25.~Treatment Period 3b:~Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32~Padsevonil 100 mg single dose on Day 33~Erythromycin 500 mg bid on Day 33.~Treatment Period 3c:~- Erythromycin 500 mg bid on Day 34 to Day 37."
11331387|NCT03480243|FG000|Participant Flow|Padsevonil and/or Erythromycin|"The study participants received treatment as follows:~Treatment Period 1: From Day 1 to Day 11:~Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4~Padsevonil 100 mg single dose on Day 5~1 week of wash-out (from evening of Day 5 to Day 11).~Treatment Period 2: From Day 12 to Day 22:~Padsevonil 100 mg bid on Day 12 to Day 15~Padsevonil 100 mg single dose on Day 16~1 week of wash-out (from evening of Day 16 to Day 22).~Treatment Period 3: From Day 23 to 37~Treatment Period 3a:~-Erythromycin 500 mg bid on Day 23 to Day 25.~Treatment Period 3b:~Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32~Padsevonil 100 mg single dose on Day 33~Erythromycin 500 mg bid on Day 33.~Treatment Period 3c:~- Erythromycin 500 mg bid on Day 34 to Day 37."
11331388|NCT03480243|OG000|Outcome|Padsevonil (Period 1) (PK-PPS)|"The study participants, of a single cohort, received Padsevonil during the Treatment Period 1 as follows: From Day 1 to Day 11:~Padsevonil 100 mg bid on Day 1 to Day 4~Padsevonil 100 mg single dose on Day 5~1 week of wash-out (from evening of Day 5 to Day 11). Study participants formed the Pharmacokinetic-Per Protocol Set (PK-PPS)."
11331389|NCT03480243|OG001|Outcome|Padsevonil (Period 2) (PK-PPS)|"The study participants, of a single cohort, received Padsevonil during the Treatment Period 2 as follows: From Day 12 to Day 22:~Padsevonil 100 mg bid on Day 12 to Day 15~Padsevonil 100 mg single dose on Day 16~1 week of wash-out (from evening of Day 16 to Day 22). Study participants formed the PK-PPS."
11331390|NCT03480243|OG002|Outcome|Padsevonil and Erythromycin (Period 3b) (PK-PPS)|"The study participants, of a single cohort, received Padsevonil and Erythromycin during the second part of the Treatment Period 3b as follows:~Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32~Padsevonil 100 mg single dose on Day 33~Erythromycin 500 mg bid on Day 33. Study participants formed the PK-PPS."
11331391|NCT03480243|OG000|Outcome|Padsevonil (Period 1+2) (FAS)|"Treatment Period 1 (Day 1 to Day 11):~Padsevonil 100 mg bid on Day 1 to Day 4~Padsevonil 100 mg single dose on Day 5~1 week of wash-out (from evening of Day 5 to Day 11)~Treatment Period 2 (Day 12 to 22):~Padsevonil 100 mg bid on Day 12 to Day 15~Padsevonil 100 mg single dose on Day 16~1 week of wash-out (from evening of Day 16 to Day 22). Study participants formed the Full Analysis Set (FAS)."
11331392|NCT03480243|OG001|Outcome|Erythromycin (Period 3a) (FAS)|Study participants received Erythromycin in Treatment Period 3a as follows: 500 mg bid on Day 23 to Day 25. Study participants formed the FAS.
11331393|NCT03480243|OG002|Outcome|Padsevonil and Erythromycin (Period 3b) (FAS)|"Study participants received Padsevonil and Erythromycin in Treatment Period 3b as follows:~Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32~Padsevonil 100 mg single dose on Day 33~Erythromycin 500 mg bid on Day 33. Study participants formed the FAS."
11331394|NCT03480243|OG003|Outcome|Erythromycin (Period 3c) (FAS)|Study participants received Erythromycin in Treatment Period 3c as follows: 500 mg bid on Day 34 to Day 37. Study participants formed the FAS.
11331395|NCT03480243|EG000|Reported Event|Padsevonil (Period 1+2) (FAS)|"Treatment Period 1 (Day 1 to Day 11):~Padsevonil 100 mg bid on Day 1 to Day 4~Padsevonil 100 mg single dose on Day 5~1 week of wash-out (from evening of Day 5 to Day 11)~Treatment Period 2 (Day 12 to 22):~Padsevonil 100 mg bid on Day 12 to Day 15~Padsevonil 100 mg single dose on Day 16~1 week of wash-out (from evening of Day 16 to Day 22). Study participants formed the Full Analysis Set (FAS)."
11331396|NCT03480243|EG001|Reported Event|Erythromycin (Period 3a) (FAS)|Study participants received Erythromycin in Treatment Period 3a as follows: 500 mg bid on Day 23 to Day 25. Study participants formed the FAS.
11331397|NCT03480243|EG002|Reported Event|Padsevonil and Erythromycin (Period 3b) (FAS)|"Study participants received Padsevonil and Erythromycin in Treatment Period 3b as follows:~Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32~Padsevonil 100 mg single dose on Day 33~Erythromycin 500 mg bid on Day 33. Study participants formed the FAS."
11331398|NCT03480243|EG003|Reported Event|Erythromycin (Period 3c) (FAS)|Study participants received Erythromycin in Treatment Period 3c as follows: 500 mg bid on Day 34 to Day 37. Study participants formed the FAS.
11333848|NCT03520400|EG000|Reported Event|Exercise Intervention Group|"Group receives one year of exercise and lifestyle intervention~Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week."
11333849|NCT03520400|EG001|Reported Event|PCI Group (Usual Care)|Group receives standard clinical care with no intervention
11331399|NCT03480425|BG000|Baseline|Esophageal Then Tracheal Intubated Patient|"Esophagus is intentionally intubated with a cuffed endotracheal tube, the cuff inflated to >30cm water pressure, a force transducer attached, and force of extubation recorded. Then Trachea is intentionally intubated the cuff inflated to >30cm water pressure, and force of extubation recorded.~Measuring extubation force: Intubation of the esophagus of anesthetized participants who are having planned endotracheal intubate for surgery; inflation of the cuff; attachment of a force transducer to the tube connector; and gently tugging the tube out of the mouth. Then intubating the esophagus and repeating the tugging procedure. Meanwhile, the force of resistance to tugging is measured with a force transducer."
11331400|NCT03480425|FG000|Participant Flow|Intubated Patient|Esophagus, then trachea, are intentionally intubated with a cuffed endotracheal tube, the cuff inflated to >30cm water pressure, a force transducer attached, and force of extubation recorded.
11331401|NCT03480425|OG000|Outcome|Esophagus|withdrawal force (N)
11331402|NCT03480425|EG000|Reported Event|Intubated Patient|all participants
11331403|NCT03480685|BG000|Baseline|IVUS Imaging vs. OCT Imaging|A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
11331404|NCT03480685|FG000|Participant Flow|IVUS Imaging vs. OCT Imaging|A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
11331405|NCT03480685|OG000|Outcome|IVUS Imaging|Vessel segment imaged with intravascular ultrasound (IVUS).
11331406|NCT03480685|OG001|Outcome|OCT Imaging|Same vessel segment imaged with optical coherence tomography (OCT).
11331407|NCT03480685|EG000|Reported Event|IVUS Imaging|Vessel segment imaged with intravascular ultrasound (IVUS).
11331408|NCT03480685|EG001|Reported Event|OCT Imaging|Same vessel segment imaged with optical coherence tomography (OCT).
11331409|NCT03480750|BG000|Baseline|Trientine With Chemotherapy Dose Level 1 (300mg)|trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331410|NCT03480750|BG001|Baseline|Trientine With Chemotherapy Dose Level 2 (600mg)|trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331411|NCT03480750|BG002|Baseline|Trientine With Chemotherapy Dose Level 3 (900mg)|trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331412|NCT03480750|BG003|Baseline|Trientine With Chemotherapy Dose Level 4 (1200mg)|trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331413|NCT03480750|BG004|Baseline|Trientine With Chemotherapy Dose Level 5 (1500mg)|trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331414|NCT03480750|BG005|Baseline|Trientine With Chemotherapy Dose Level 6 (1800mg)|trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331415|NCT03480750|BG006|Baseline|Total|Total of all reporting groups
11331416|NCT03480750|FG000|Participant Flow|Trientine With Chemotherapy Dose Level 1 (300mg)|"trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331417|NCT03480750|FG001|Participant Flow|Trientine With Chemotherapy Dose Level 2 (600mg)|"trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331418|NCT03480750|FG002|Participant Flow|Trientine With Chemotherapy Dose Level 3 (900mg)|"trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331419|NCT03480750|FG003|Participant Flow|Trientine With Chemotherapy Dose Level 4 (1200mg)|"trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331420|NCT03480750|FG004|Participant Flow|Trientine With Chemotherapy Dose Level 5 (1500mg)|"trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331421|NCT03480750|FG005|Participant Flow|Trientine With Chemotherapy Dose Level 6 (1800mg)|"trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331422|NCT03480750|OG000|Outcome|Trientine With Chemotherapy at Dose Level 1 (300mg/d)|"trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 1st dose level: 300mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331423|NCT03480750|OG001|Outcome|Trientine With Chemotherapy at Dose Level 2 (600mg/d)|"rientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 2nd dose level: 600mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331424|NCT03480750|OG002|Outcome|Trientine With Chemotherapy at Dose Level 3 (900mg/d)|"trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 3rd dose level: 900mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1"
11331425|NCT03480750|OG003|Outcome|Trientine With Chemotherapy at Dose Level 4 (1200mg/d)|"trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 4th dose level: 1200mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331426|NCT03480750|OG004|Outcome|Trientine With Chemotherapy Dose Level 5 (1500mg/d)|"trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 5th dose level: 1500mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331427|NCT03480750|OG005|Outcome|Trientine With Chemotherapy Dose Level 6 (1800mg/d)|"trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 6th dose level: 1800mg)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331428|NCT03480750|OG000|Outcome|Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)|trientine dihydrochloride: trientine dihydrochloride 300 - 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331429|NCT03480750|OG000|Outcome|Trientine With Chemotherapy Dose Level 1 (300mg)|trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331430|NCT03480750|OG001|Outcome|Trientine With Chemotherapy Dose Level 2 (600mg)|trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331431|NCT03480750|OG002|Outcome|Trientine With Chemotherapy Dose Level 3 (900mg)|trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331432|NCT03480750|OG003|Outcome|Trientine With Chemotherapy Dose Level 4 (1200mg)|trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331433|NCT03480750|OG004|Outcome|Trientine With Chemotherapy Dose Level 5 (1500mg)|trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331434|NCT03480750|OG005|Outcome|Trientine With Chemotherapy Dose Level 6 (1800mg)|trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331435|NCT03480750|OG000|Outcome|Trientine With Chemotherapy|"trientine dihydrochloride PO daily [through dose level 1 (300mg/day) to level 6 (1800mg/day)] plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily [through dose level 1 (300mg/day) to level 6 (1800mg/day)]~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331436|NCT03480750|OG000|Outcome|Trientine With Chemotherapy|"trientine dihydrochloride PO daily (in different dose levels) plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1~trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels)~pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1~carboplatin: carboplatin AUC 4 IV D1"
11331437|NCT03480750|EG000|Reported Event|Trientine With Chemotherapy Dose Level 1 (300mg)|trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331438|NCT03480750|EG001|Reported Event|Trientine With Chemotherapy Dose Level 2 (600mg)|trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331439|NCT03480750|EG002|Reported Event|Trientine With Chemotherapy Dose Level 3 (900mg)|trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331440|NCT03480750|EG003|Reported Event|Trientine With Chemotherapy Dose Level 4 (1200mg)|trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331441|NCT03480750|EG004|Reported Event|Trientine With Chemotherapy Dose Level 5 (1500mg)|trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331442|NCT03480750|EG005|Reported Event|Trientine With Chemotherapy Dose Level 6 (1800mg)|trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
11331443|NCT03480763|BG000|Baseline|V114|Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331444|NCT03480763|BG001|Baseline|Prevnar 13™|Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331445|NCT03480763|BG002|Baseline|Total|Total of all reporting groups
11331446|NCT03480763|FG000|Participant Flow|V114|Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331447|NCT03480763|FG001|Participant Flow|Prevnar 13™|Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331448|NCT03480763|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331449|NCT03480763|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331450|NCT03480763|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331451|NCT03480763|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331452|NCT03480763|OG000|Outcome|V114|Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331453|NCT03480763|OG001|Outcome|Prevnar 13™|Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
10842971|NCT00251004|FG002|Participant Flow|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
11331454|NCT03480763|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
10848225|NCT00289185|BG001|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
10848226|NCT00289185|BG002|Baseline|Total|Total of all reporting groups
11331455|NCT03480763|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331456|NCT03480763|EG002|Reported Event|V114 (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
11331457|NCT03480763|EG003|Reported Event|Prevnar 13™ (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
10848227|NCT00289185|FG000|Participant Flow|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
11336277|NCT03565068|FG002|Participant Flow|Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg|Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11336278|NCT03565068|FG003|Participant Flow|Panel B (Schizophrenia Participants): Placebo Monotherapy|Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
11333850|NCT03520920|BG000|Baseline|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11331458|NCT03480841|BG000|Baseline|LENA With Feedback|"Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment.~Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own."
11331459|NCT03480841|FG000|Participant Flow|LENA With Feedback|"Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment.~Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own."
10842222|NCT00245219|OG002|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
10842223|NCT00245219|EG000|Reported Event|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
10842224|NCT00245219|EG001|Reported Event|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
10842225|NCT00245219|EG002|Reported Event|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
10842226|NCT00245466|BG000|Baseline|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842227|NCT00245466|BG001|Baseline|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842228|NCT00245466|BG002|Baseline|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842229|NCT00245466|BG003|Baseline|Total|Total of all reporting groups
10842230|NCT00245466|FG000|Participant Flow|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842231|NCT00245466|FG001|Participant Flow|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842232|NCT00245466|FG002|Participant Flow|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842233|NCT00245466|OG000|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842234|NCT00245466|OG001|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842235|NCT00245466|OG002|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842236|NCT00245466|EG000|Reported Event|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842237|NCT00245466|EG001|Reported Event|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842238|NCT00245466|EG002|Reported Event|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
10842239|NCT00245518|BG000|Baseline|Isoflavone|"Isoflavone~Isoflavone"
10842240|NCT00245518|BG001|Baseline|Placebo|Placebos
10842241|NCT00245518|BG002|Baseline|Total|Total of all reporting groups
10842242|NCT00245518|FG000|Participant Flow|Isoflavone|"Isoflavone~Isoflavone"
10842243|NCT00245518|FG001|Participant Flow|Placebo|Placebos
10842244|NCT00245518|OG000|Outcome|Placebo|Placebo
10842245|NCT00245518|OG001|Outcome|Isoflavone|"Isoflavone~Isoflavone"
10842246|NCT00245518|EG000|Reported Event|Isoflavone|"Isoflavone~Isoflavone"
10842247|NCT00245518|EG001|Reported Event|Placebo|Placebos
10842248|NCT00245557|BG000|Baseline|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
10842249|NCT00245557|BG001|Baseline|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
10842250|NCT00245557|BG002|Baseline|Total|Total of all reporting groups
10842251|NCT00245557|FG000|Participant Flow|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
10842252|NCT00245557|FG001|Participant Flow|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
10842253|NCT00245557|OG000|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
10842254|NCT00245557|OG001|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
10842255|NCT00245557|OG002|Outcome|Post-treatment Depressed|
10842256|NCT00245557|EG000|Reported Event|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
10842257|NCT00245557|EG001|Reported Event|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
10842258|NCT00245583|BG000|Baseline|Topiramate|"25mg to 300mg daily dose~Topiramate: minimum does of 50mg/day"
10842259|NCT00245583|BG001|Baseline|Placebo|"placebo equivalent tablets~Placebo: matching tablet"
10842260|NCT00245583|BG002|Baseline|Total|Total of all reporting groups
10842261|NCT00245583|FG000|Participant Flow|Topiramate|"25mg to 300mg daily dose~Topiramate: minimum does of 50mg/day"
10842262|NCT00245583|FG001|Participant Flow|Placebo|"placebo equivalent tablets~Placebo: matching tablet"
10842263|NCT00245583|OG000|Outcome|Topiramate|"25mg to 300mg daily dose~Topiramate: minimum does of 50mg/day"
10842264|NCT00245583|OG001|Outcome|Placebo|"placebo equivalent tablets~Placebo: matching tablet"
10842265|NCT00245583|EG000|Reported Event|Topiramate|"25mg to 300mg daily dose~Topiramate: minimum does of 50mg/day"
10842266|NCT00245583|EG001|Reported Event|Placebo|"placebo equivalent tablets~Placebo: matching tablet"
10842267|NCT00245635|BG000|Baseline|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
10842268|NCT00245635|BG001|Baseline|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
10842269|NCT00245635|BG002|Baseline|Total|Total of all reporting groups
10842270|NCT00245635|FG000|Participant Flow|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
10842271|NCT00245635|FG001|Participant Flow|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
10842272|NCT00245635|OG000|Outcome|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
10842273|NCT00245635|OG001|Outcome|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
10842274|NCT00245635|EG000|Reported Event|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
10842275|NCT00245635|EG001|Reported Event|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
10842276|NCT00245765|BG000|Baseline|Placebo (ITT)|Subcutaneous injections of Placebo every 2 weeks
10842277|NCT00245765|BG001|Baseline|Certolizumab Pegol 200 mg (ITT)|Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
10842278|NCT00245765|BG002|Baseline|Certolizumab Pegol 400 mg (ITT)|Subcutaneous injections of 400 mg every 2 weeks
10842279|NCT00245765|BG003|Baseline|Total Title|
10842280|NCT00245765|FG000|Participant Flow|Placebo (ITT)|Subcutaneous injections of Placebo every 2 weeks
10842281|NCT00245765|FG001|Participant Flow|Certolizumab Pegol 200 mg (ITT)|Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
10842282|NCT00245765|FG002|Participant Flow|Certolizumab Pegol 400 mg (ITT)|Subcutaneous injections of 400 mg every 2 weeks
10842283|NCT00245765|OG000|Outcome|Placebo (ITT)|Subcutaneous injections of Placebo every 2 weeks
10842284|NCT00245765|OG001|Outcome|Certolizumab Pegol 200 mg (ITT)|Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
10842285|NCT00245765|OG002|Outcome|Certolizumab Pegol 400 mg (ITT)|Subcutaneous injections of 400 mg every 2 weeks
10842286|NCT00245765|EG000|Reported Event|Placebo (SS)|Subcutaneous injections of Placebo every 2 weeks
10842287|NCT00245765|EG001|Reported Event|Certolizumab Pegol 200 mg (SS)|Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
10842288|NCT00245765|EG002|Reported Event|Certolizumab Pegol 400 mg (SS)|Subcutaneous injections of 400 mg every 2 weeks
10842289|NCT00245856|BG000|Baseline|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
10842290|NCT00245856|FG000|Participant Flow|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
10842291|NCT00245856|FG001|Participant Flow|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
10842292|NCT00245856|OG000|Outcome|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
10842293|NCT00245856|OG000|Outcome|Dalteparin + Warfarin or Dalteparin Alone|Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone
10842294|NCT00245856|OG000|Outcome|Dalteparin + Warfarin/Dalteparin Alone|Major bleeding rates
10842295|NCT00245856|EG000|Reported Event|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
10842296|NCT00245856|EG001|Reported Event|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
10842297|NCT00246012|BG000|Baseline|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842298|NCT00246012|BG001|Baseline|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842299|NCT00246012|BG002|Baseline|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
10842300|NCT00246012|BG003|Baseline|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842301|NCT00246012|BG004|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842302|NCT00246012|BG005|Baseline|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
10842303|NCT00246012|BG006|Baseline|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842304|NCT00246012|BG007|Baseline|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842305|NCT00246012|BG008|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842306|NCT00246012|BG009|Baseline|Total|Total of all reporting groups
10842307|NCT00246012|FG000|Participant Flow|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842308|NCT00246012|FG001|Participant Flow|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842309|NCT00246012|FG002|Participant Flow|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
11333851|NCT03520920|BG001|Baseline|Relapsed/Refractory Follicular Lymphoma|Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11331460|NCT03480841|OG000|Outcome|LENA With Feedback|"Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment.~Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own."
11331461|NCT03480841|EG000|Reported Event|LENA With Feedback|"Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment.~Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own."
11331462|NCT03480919|BG000|Baseline|Shen Men Acupuncture|"Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.~Shen Men acupuncture: 20-minute acupuncture session~Epidural injection: Epidural injection for the relief of back pain"
11331463|NCT03480919|BG001|Baseline|Sham Acupuncture|"Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.~Epidural injection: Epidural injection for the relief of back pain"
11331464|NCT03480919|BG002|Baseline|Simulated Acupuncture|"Acupuncture will be simulated with a paper clip.~Epidural injection: Epidural injection for the relief of back pain"
11331465|NCT03480919|BG003|Baseline|Total|Total of all reporting groups
11331466|NCT03480919|FG000|Participant Flow|Shen Men Acupuncture|"Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.~Shen Men acupuncture: 20-minute acupuncture session~Epidural injection: Epidural injection for the relief of back pain"
11331467|NCT03480919|FG001|Participant Flow|Sham Acupuncture|"Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.~Epidural injection: Epidural injection for the relief of back pain"
11331468|NCT03480919|FG002|Participant Flow|Simulated Acupuncture|"Acupuncture will be simulated with a paper clip.~Epidural injection: Epidural injection for the relief of back pain"
11331469|NCT03480919|OG000|Outcome|Shen Men Acupuncture|"Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.~Shen Men acupuncture: 20-minute acupuncture session~Epidural injection: Epidural injection for the relief of back pain"
11331470|NCT03480919|OG001|Outcome|Sham Acupuncture|"Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.~Epidural injection: Epidural injection for the relief of back pain"
11331471|NCT03480919|OG002|Outcome|Simulated Acupuncture|"Acupuncture will be simulated with a paper clip.~Epidural injection: Epidural injection for the relief of back pain"
11331472|NCT03480919|EG000|Reported Event|Shen Men Acupuncture|"Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.~Shen Men acupuncture: 20-minute acupuncture session~Epidural injection: Epidural injection for the relief of back pain"
11331473|NCT03480919|EG001|Reported Event|Sham Acupuncture|"Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.~Epidural injection: Epidural injection for the relief of back pain"
11331474|NCT03480919|EG002|Reported Event|Simulated Acupuncture|"Acupuncture will be simulated with a paper clip.~Epidural injection: Epidural injection for the relief of back pain"
11331475|NCT03480932|BG000|Baseline|SOF+DAC+PEG|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C"
11331476|NCT03480932|BG001|Baseline|SOF+DAC, DOT|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331477|NCT03480932|BG002|Baseline|SOF+DAC, Standard|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331478|NCT03480932|BG003|Baseline|Total|Total of all reporting groups
11331479|NCT03480932|FG000|Participant Flow|SOF+DAC+PEG|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C"
11331480|NCT03480932|FG001|Participant Flow|SOF+DAC, DOT|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331481|NCT03480932|FG002|Participant Flow|SOF+DAC, Standard|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331482|NCT03480932|OG000|Outcome|SOF+DAC+PEG|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C"
11331483|NCT03480932|OG001|Outcome|SOF+DAC, DOT|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331484|NCT03480932|OG002|Outcome|SOF+DAC, Standard|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331485|NCT03480932|EG000|Reported Event|SOF+DAC+PEG|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C~Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C"
11331486|NCT03480932|EG001|Reported Event|SOF+DAC, DOT|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331487|NCT03480932|EG002|Reported Event|SOF+DAC, Standard|"Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)~Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C~Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C"
11331488|NCT03481270|BG000|Baseline|Discordant|"Does not receive the concordant provider.~Concordant: We will be randomizing across providers - we are particularly interested in racial concordance."
11331489|NCT03481270|BG001|Baseline|Concordant|"The intervention is that the subject receives the concordant provider.~Concordant: We will be randomizing across providers - we are particularly interested in racial concordance."
11331490|NCT03481270|BG002|Baseline|Total|Total of all reporting groups
11331491|NCT03481270|FG000|Participant Flow|Discordant|"Subject is not randomized to a concordant provider.~Concordant: The black male subject is seen by a non-black male doctor."
11331492|NCT03481270|FG001|Participant Flow|Concordant|"Subject is randomized to a concordant provider.~Concordant: The black male subject is seen by a black male doctor."
11331493|NCT03481270|OG000|Outcome|Discordant|"Subject is not randomized to a concordant provider.~Concordant: The black male subject is seen by a non-black male doctor."
11331494|NCT03481270|OG001|Outcome|Concordant|"Subject is randomized to a concordant provider.~Concordant: The black male subject is seen by a black male doctor."
11331495|NCT03481270|EG000|Reported Event|Discordant|"Subject is not randomized to a concordant provider.~Concordant: The black male subject is seen by a non-black male doctor."
11331496|NCT03481270|EG001|Reported Event|Concordant|"Subject is randomized to a concordant provider.~Concordant: The black male subject is seen by a black male doctor."
11331497|NCT03481309|BG000|Baseline|Anode -> Cathode -> Sham|During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331498|NCT03481309|BG001|Baseline|Anode -> Sham -> Cathode|During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331499|NCT03481309|BG002|Baseline|Cathode -> Anode -> Sham|During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331500|NCT03481309|BG003|Baseline|Cathode -> Sham -> Anode|During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331501|NCT03481309|BG004|Baseline|Sham -> Anode -> Cathode|During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331502|NCT03481309|BG005|Baseline|Sham -> Cathode -> Anode|During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331503|NCT03481309|BG006|Baseline|Total|Total of all reporting groups
11331504|NCT03481309|FG000|Participant Flow|Anode -> Cathode -> Sham|During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331505|NCT03481309|FG001|Participant Flow|Anode -> Sham -> Cathode|During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331506|NCT03481309|FG002|Participant Flow|Cathode -> Anode -> Sham|During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331507|NCT03481309|FG003|Participant Flow|Cathode -> Sham -> Anode|During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331508|NCT03481309|FG004|Participant Flow|Sham -> Anode -> Cathode|During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331509|NCT03481309|FG005|Participant Flow|Sham -> Cathode -> Anode|During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
11331510|NCT03481309|OG000|Outcome|Anodal tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.~anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex."
11331511|NCT03481309|OG001|Outcome|Cathodal tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.~cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex."
11331512|NCT03481309|OG002|Outcome|Sham tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.~sham tDCS: The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions."
11331513|NCT03481309|EG000|Reported Event|Anodal tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.~anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex."
11331514|NCT03481309|EG001|Reported Event|Cathodal tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.~cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex."
11331515|NCT03481309|EG002|Reported Event|Sham tDCS|"Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.~sham tDCS: The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions."
11331516|NCT03481595|BG000|Baseline|Group A|Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
11331517|NCT03481595|BG001|Baseline|Group B|"Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.~HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care."
11331518|NCT03481595|BG002|Baseline|Total|Total of all reporting groups
11331519|NCT03481595|FG000|Participant Flow|Group A|Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
11331520|NCT03481595|FG001|Participant Flow|Group B|"Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.~HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care."
11331521|NCT03481595|OG000|Outcome|Group A|Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
11331522|NCT03481595|OG001|Outcome|Group B|"Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.~HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care."
11331523|NCT03481595|EG000|Reported Event|Group A|Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
11331524|NCT03481595|EG001|Reported Event|Group B|"Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.~HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care."
11331525|NCT03481725|BG000|Baseline|Peripheral Nerve Stimulation|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
11331526|NCT03481725|BG001|Baseline|Sham|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
11331527|NCT03481725|BG002|Baseline|Total|Total of all reporting groups
11331528|NCT03481725|FG000|Participant Flow|Peripheral Nerve Stimulation|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
11331529|NCT03481725|FG001|Participant Flow|Sham|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
11331530|NCT03481725|OG000|Outcome|Peripheral Nerve Stimulation|"ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current~ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio): ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days"
11331531|NCT03481725|OG001|Outcome|Sham|"SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current~SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio): SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days"
11331532|NCT03481725|OG000|Outcome|Peripheral Nerve Stimulation|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
11331533|NCT03481725|OG001|Outcome|Sham|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
11331534|NCT03481725|EG000|Reported Event|Peripheral Nerve Stimulation|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
11331535|NCT03481725|EG001|Reported Event|Sham|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
11331536|NCT03481816|BG000|Baseline|Arm 1/Dose De-Escalation|"Subjects enrolled to dose de-escalation cohorts.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331537|NCT03481816|BG001|Baseline|Arm 2/Dose Expansion|"Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331538|NCT03481816|BG002|Baseline|Total|Total of all reporting groups
11331539|NCT03481816|FG000|Participant Flow|Arm 1/Dose De-escalation|"Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331540|NCT03481816|FG001|Participant Flow|Arm 2/Dose Expansion|"Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331541|NCT03481816|OG000|Outcome|Arm 1/Dose De-Escalation|"Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11333852|NCT03520920|BG002|Baseline|Relapsed/Refractory Marginal Zone Lymphoma|Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11333853|NCT03520920|BG003|Baseline|Total|Total of all reporting groups
10842310|NCT00246012|FG003|Participant Flow|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842311|NCT00246012|FG004|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842312|NCT00246012|FG005|Participant Flow|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
10842313|NCT00246012|FG006|Participant Flow|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842314|NCT00246012|FG007|Participant Flow|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842315|NCT00246012|FG008|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842316|NCT00246012|OG000|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842317|NCT00246012|OG001|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842318|NCT00246012|OG002|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
10842319|NCT00246012|OG003|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842320|NCT00246012|OG004|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842321|NCT00246012|OG000|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
10842322|NCT00246012|OG001|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842323|NCT00246012|OG002|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842324|NCT00246012|OG003|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842325|NCT00246012|OG000|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842326|NCT00246012|OG001|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842327|NCT00246012|EG000|Reported Event|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842328|NCT00246012|EG001|Reported Event|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
10842329|NCT00246012|EG002|Reported Event|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
10842330|NCT00246012|EG003|Reported Event|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842331|NCT00246012|EG004|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842332|NCT00246012|EG005|Reported Event|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
10842333|NCT00246012|EG006|Reported Event|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842334|NCT00246012|EG007|Reported Event|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
10842335|NCT00246012|EG008|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
10842336|NCT00246025|BG000|Baseline|Treatment Group With Placebo|Patients were treated with matching Placebo.
10842337|NCT00246025|BG001|Baseline|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
10842338|NCT00246025|BG002|Baseline|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
10842339|NCT00246025|BG003|Baseline|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
10842340|NCT00246025|BG004|Baseline|Total|Total of all reporting groups
10842341|NCT00246025|FG000|Participant Flow|Treatment Group With Placebo|Patients were treated with matching Placebo.
10842342|NCT00246025|FG001|Participant Flow|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
11331542|NCT03481816|OG001|Outcome|Arm 2/Dose Expansion|"Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331543|NCT03481816|OG000|Outcome|Arm 1/Dose De-Escalation|"Subjects enrolled to dose de-escalation cohorts.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331544|NCT03481816|OG000|Outcome|Arm 2/Dose Expansion|"Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331545|NCT03481816|EG000|Reported Event|Arm 1/Dose De-Escalation|"Subjects enrolled to dose de-escalation cohorts.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331546|NCT03481816|EG001|Reported Event|Arm 2/Dose Expansion|"Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.~ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.~ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations."
11331547|NCT03482011|BG000|Baseline|Placebo Q4W|Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
11331548|NCT03482011|BG001|Baseline|250 mg Miri Q4W|Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
11331549|NCT03482011|BG002|Baseline|Total|Total of all reporting groups
11331550|NCT03482011|FG000|Participant Flow|Placebo Q4W|Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
11331551|NCT03482011|FG001|Participant Flow|250 mg Miri Q4W|Induction Period: Participants received 250 milligrams (mg) mirikizumab (miri) administered SC Q4W.
11331552|NCT03482011|FG002|Participant Flow|Placebo Q4W to Placebo Q8W (Placebo Responder)|"Maintenance Period: Participants received placebo administered SC every 8 weeks (Q8W). Responders had ≥PASI 90.~Participants had received placebo administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331553|NCT03482011|FG003|Participant Flow|Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90.~Participants had received placebo administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331554|NCT03482011|FG004|Participant Flow|250 mg Miri Q4W Responders to Placebo Q8W|"Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331555|NCT03482011|FG005|Participant Flow|250 mg Miri Q4W Responders to 125 mg Miri Q8W|"Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331556|NCT03482011|FG006|Participant Flow|250 mg Miri Q4W Responder to 250 mg Miri Q8W|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331557|NCT03482011|FG007|Participant Flow|250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders)|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period.~Follow-up Period: Participants did not receive drug during the follow-up period."
11331558|NCT03482011|OG000|Outcome|Placebo Q4W|Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
11331559|NCT03482011|OG001|Outcome|250 mg Miri Q4W|Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
10842343|NCT00246025|FG002|Participant Flow|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
11331560|NCT03482011|OG000|Outcome|250 mg Miri Q4W Responders to Placebo Q8W|"Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331561|NCT03482011|OG001|Outcome|250 mg Miri Q4W Responders to 125 mg Miri Q8W|"Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331562|NCT03482011|OG002|Outcome|250 mg Miri Q4W Responder to 250 mg Miri Q8W|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331563|NCT03482011|OG000|Outcome|250 mg Miri Q4W|Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
11331564|NCT03482011|EG000|Reported Event|Placebo Q4W|Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
11331565|NCT03482011|EG001|Reported Event|250 mg Miri Q4W|Induction Period: Participants received 250 mg mirikizumab (miri) administered SC Q4W.
11331566|NCT03482011|EG002|Reported Event|Placebo Q4W to Placebo Q8W (Placebo Responder)|"Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.~Participants had received placebo administered SC Q4W during induction period."
11331567|NCT03482011|EG003|Reported Event|Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90.~Participants had received placebo administered SC Q4W during induction period."
11331568|NCT03482011|EG004|Reported Event|250 mg Miri Q4W Responders to Placebo Q8W|"Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331569|NCT03482011|EG005|Reported Event|250 mg Miri Q4W Responders to 125 mg Miri Q8W|"Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331570|NCT03482011|EG006|Reported Event|250 mg Miri Q4W Responder to 250 mg Miri Q8W|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331571|NCT03482011|EG007|Reported Event|250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)|"Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90.~Participants had received 250 mirikizumab administered SC Q4W during induction period."
11331572|NCT03482011|EG008|Reported Event|Relapse|"Participants that relapsed were in the following arms:~Placebo Q4W to Placebo Q8W (Placebo Responder).~250 mg Miri Q4W Responders to Placebo Q8W.~250 mg Miri Q4W Responders to 125 mg Miri Q8W.~250 mg Miri Q4W Responder to 250 mg Miri Q8W."
11331573|NCT03482011|EG009|Reported Event|Placebo Q4W to Placebo Q8W (Responder) Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331574|NCT03482011|EG010|Reported Event|Placebo Q4W Discontinued During Induction-Follow-up Period|"Follow-up Period: Participants did not receive drug during the follow-up period.~Participants discontinued (DC) before induction week 16 and counted as placebo non-responders."
11331575|NCT03482011|EG011|Reported Event|Placebo Q4W to Placebo Non-Responder-Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331576|NCT03482011|EG012|Reported Event|250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331577|NCT03482011|EG013|Reported Event|250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331578|NCT03482011|EG014|Reported Event|250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331579|NCT03482011|EG015|Reported Event|250 Miri Q4W Discontinued During Induction-Follow-up|"Follow-up Period: Participants did not receive drug during the follow-up period.~Participants discontinued (DC) before induction week 16 and counted as miri non-responders."
11331580|NCT03482011|EG016|Reported Event|250 Miri Q4W to Miri Nonresponder-Follow-up Period|Follow-up Period: Participants did not receive drug during the follow-up period.
11331581|NCT03482453|BG000|Baseline|Part 1: Pooled Placebo|TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
11331582|NCT03482453|BG001|Baseline|Part 1 Cohort 1: TAK-788 20 mg|TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
11331583|NCT03482453|BG002|Baseline|Part 1 Cohort 2: TAK-788 40 mg|TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
11331584|NCT03482453|BG003|Baseline|Part 1 Cohort 3: TAK-788 80 mg|TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
11331585|NCT03482453|BG004|Baseline|Part 1 Cohort 4: TAK-788 120 mg|TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
11331586|NCT03482453|BG005|Baseline|Part 1 Cohort 5: TAK-788 160 mg|TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
11331587|NCT03482453|BG006|Baseline|Part 2: TAK-788 120 mg Fed + TAK-788 120 mg Fasted|TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
11331588|NCT03482453|BG007|Baseline|Part 2: TAK-788 120 mg Fasted + TAK-788 120 mg Fed|TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
11331589|NCT03482453|BG008|Baseline|Part 2: TAK-788 160 mg Fed + TAK-788 160 mg Fasted|TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
11331590|NCT03482453|BG009|Baseline|Part 2: TAK-788 160 mg Fasted + TAK-788 160 mg Fed|TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
11331591|NCT03482453|BG010|Baseline|Part 3: TAK-788 DiC A + TAK-788 DiC B|TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
11331592|NCT03482453|BG011|Baseline|Part 3: TAK-788 DiC B + TAK-788 DiC A|TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
11331593|NCT03482453|BG012|Baseline|Total|Total of all reporting groups
11331594|NCT03482453|FG000|Participant Flow|Part 1: Pooled Placebo|TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
11331595|NCT03482453|FG001|Participant Flow|Part 1 Cohort 1: TAK-788 20 mg|TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
11331596|NCT03482453|FG002|Participant Flow|Part 1 Cohort 2: TAK-788 40 mg|TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
11331597|NCT03482453|FG003|Participant Flow|Part 1 Cohort 3: TAK-788 80 mg|TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
11331598|NCT03482453|FG004|Participant Flow|Part 1 Cohort 4: TAK-788 120 mg|TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
11331599|NCT03482453|FG005|Participant Flow|Part 1 Cohort 5: TAK-788 160 mg|TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
11331600|NCT03482453|FG006|Participant Flow|Part 2: TAK-788 120 mg Fed + TAK-788 120 mg Fasted|TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
11331601|NCT03482453|FG007|Participant Flow|Part 2: TAK-788 120 mg Fasted + TAK-788 120 mg Fed|TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
11331602|NCT03482453|FG008|Participant Flow|Part 2: TAK-788 160 mg Fed + TAK-788 160 mg Fasted|TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
11331603|NCT03482453|FG009|Participant Flow|Part 2: TAK-788 160 mg Fasted + TAK-788 160 mg Fed|TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
11331604|NCT03482453|FG010|Participant Flow|Part 3: TAK-788 DiC A + TAK-788 DiC B|TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
11331605|NCT03482453|FG011|Participant Flow|Part 3: TAK-788 DiC B + TAK-788 DiC A|TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
11331606|NCT03482453|OG000|Outcome|Part 1: Pooled Placebo|TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
11331607|NCT03482453|OG001|Outcome|Part 1 Cohort 1: TAK-788 20 mg|TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
11331608|NCT03482453|OG002|Outcome|Part 1 Cohort 2: TAK-788 40 mg|TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
11331609|NCT03482453|OG003|Outcome|Part 1 Cohort 3: TAK-788 80 mg|TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
11331610|NCT03482453|OG004|Outcome|Part 1 Cohort 4: TAK-788 120 mg|TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
11331611|NCT03482453|OG005|Outcome|Part 1 Cohort 5: TAK-788 160 mg|TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
11331612|NCT03482453|OG000|Outcome|Part 2: TAK-788 120 mg Fed|TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
11331613|NCT03482453|OG001|Outcome|Part 2: TAK-788 120 mg Fasted|TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
11331614|NCT03482453|OG002|Outcome|Part 2: TAK-788 160 mg Fed|TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
11331615|NCT03482453|OG003|Outcome|Part 2: TAK-788 160 mg Fasted|TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
11331616|NCT03482453|OG000|Outcome|Part 3: TAK-788 DiC A|TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
11331617|NCT03482453|OG001|Outcome|Part 3: TAK-788 DiC B|TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
11331618|NCT03482453|OG000|Outcome|Part 1 Cohort 1: TAK-788 20 mg|TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
11331619|NCT03482453|OG001|Outcome|Part 1 Cohort 2: TAK-788 40 mg|TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
11331620|NCT03482453|OG002|Outcome|Part 1 Cohort 3: TAK-788 80 mg|TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
11331621|NCT03482453|OG003|Outcome|Part 1 Cohort 4: TAK-788 120 mg|TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
11331622|NCT03482453|OG004|Outcome|Part 1 Cohort 5: TAK-788 160 mg|TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
11331623|NCT03482453|OG004|Outcome|Part 3: TAK-788 160 mg DiC A|TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
11331624|NCT03482453|OG005|Outcome|Part 3: TAK-788 160 mg DiC B|TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
11331625|NCT03482453|OG001|Outcome|Part 2: TAK-788 120 mg Fasted|TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
11331626|NCT03482453|OG003|Outcome|Part 2: TAK-788 160 mg Fasted|TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
11331627|NCT03482453|OG002|Outcome|Part 2: TAK-788 160 mg|TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A).
11331628|NCT03482453|EG000|Reported Event|Part 1: Pooled Placebo|TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
11331629|NCT03482453|EG001|Reported Event|Part 1 Cohort 1: TAK-788 20 mg|TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
11331630|NCT03482453|EG002|Reported Event|Part 1 Cohort 2: TAK-788 40 mg|TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
11331631|NCT03482453|EG003|Reported Event|Part 1 Cohort 3: TAK-788 80 mg|TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
11331632|NCT03482453|EG004|Reported Event|Part 1 Cohort 4: TAK-788 120 mg|TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
11331633|NCT03482453|EG005|Reported Event|Part 1 Cohort 5: TAK-788 160 mg|TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
11331634|NCT03482453|EG006|Reported Event|Part 2: TAK-788 120 mg Fed|TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
11331635|NCT03482453|EG007|Reported Event|Part 2: TAK-788 120 mg Fasted|TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
11331636|NCT03482453|EG008|Reported Event|Part 2: TAK-788 160 mg Fed|TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
11331637|NCT03482453|EG009|Reported Event|Part 2: TAK-788 160 mg Fasted|TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
11331638|NCT03482453|EG010|Reported Event|Part 3: TAK-788 DiC A|TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
11331639|NCT03482453|EG011|Reported Event|Part 3: TAK-788 DiC B|TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
11331640|NCT03482583|BG000|Baseline|Cognitive Behavior Therapy With NRT|"Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.~Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform."
11331641|NCT03482583|BG001|Baseline|Referral to Area Health Education Center|"The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331642|NCT03482583|BG002|Baseline|Referral to Qutiline|"Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.~The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331643|NCT03482583|BG003|Baseline|Total|Total of all reporting groups
11331644|NCT03482583|FG000|Participant Flow|Cognitive Behavior Therapy With NRT|"Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.~Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform."
11331645|NCT03482583|FG001|Participant Flow|Referral to Area Health Education Center|"The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331646|NCT03482583|FG002|Participant Flow|Referral to Qutiline|"Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.~The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331647|NCT03482583|OG000|Outcome|Cognitive Behavior Therapy With NRT|"Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.~Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform."
11331648|NCT03482583|OG001|Outcome|Referral to Area Health Education Center|"The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331649|NCT03482583|OG002|Outcome|Referral to Qutiline|"Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.~The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331650|NCT03482583|OG000|Outcome|Eligible Patients|Smokers visiting the clinic during the study period
11331651|NCT03482583|EG000|Reported Event|Cognitive Behavior Therapy With NRT|"Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.~Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform."
11331652|NCT03482583|EG001|Reported Event|Referral to Area Health Education Center|"The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331653|NCT03482583|EG002|Reported Event|Referral to Qutiline|"Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.~The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.~Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment"
11331654|NCT03482635|BG000|Baseline|Placebo|A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331655|NCT03482635|BG001|Baseline|300 mg Spesolimab (BI 655130) SD|A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331656|NCT03482635|BG002|Baseline|450 mg Spesolimab (BI 655130) q4w|450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331657|NCT03482635|BG003|Baseline|1200 mg Spesolimab (BI 655130) q4w|1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331658|NCT03482635|BG004|Baseline|Total|Total of all reporting groups
11331659|NCT03482635|FG000|Participant Flow|Placebo|A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331660|NCT03482635|FG001|Participant Flow|300 mg Spesolimab (BI 655130) SD|A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331661|NCT03482635|FG002|Participant Flow|450 mg Spesolimab (BI 655130) q4w|450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331662|NCT03482635|FG003|Participant Flow|1200 mg Spesolimab (BI 655130) q4w|1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331663|NCT03482635|OG000|Outcome|Placebo|A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331664|NCT03482635|OG001|Outcome|300 mg Spesolimab (BI 655130) SD|A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331665|NCT03482635|OG002|Outcome|450 mg Spesolimab (BI 655130) q4w|450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331666|NCT03482635|OG003|Outcome|1200 mg Spesolimab (BI 655130) q4w|1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331667|NCT03482635|EG000|Reported Event|Placebo|A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331668|NCT03482635|EG001|Reported Event|300 mg Spesolimab (BI 655130) SD|A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331669|NCT03482635|EG002|Reported Event|450 mg Spesolimab (BI 655130) q4w|450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331670|NCT03482635|EG003|Reported Event|1200 mg Spesolimab (BI 655130) q4w|1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
11331671|NCT03482713|BG000|Baseline|Gefapixant 45 mg|Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.
11331672|NCT03482713|BG001|Baseline|Placebo|Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
11331673|NCT03482713|BG002|Baseline|Total|Total of all reporting groups
11331674|NCT03482713|FG000|Participant Flow|Gefapixant 45 mg|Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.
11331675|NCT03482713|FG001|Participant Flow|Placebo|Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
11331676|NCT03482713|OG000|Outcome|Gefapixant 45 mg|Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.
11331677|NCT03482713|OG001|Outcome|Placebo|Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
11331678|NCT03482713|EG000|Reported Event|Gefapixant 45 mg|Participants received a gefapixant 45 mg film-coated tablet twice daily for 28 days.
11331679|NCT03482713|EG001|Reported Event|Placebo|Participants received a film-coated placebo tablet matching gefapixant twice daily for 28 days.
11331680|NCT03482882|BG000|Baseline|Pimavanserin Safety Analysis Set|The Safety Analysis Set (SAS) includes all subjects (47 participants) who received at least one dose of study drug (34mg pimavanserin taken as two 17mg tablets, once daily by mouth)
11331681|NCT03482882|FG000|Participant Flow|Pimavanserin|Pimavanserin 34 mg, taken as 2 tablets of pimavanserin 17 mg as a single dose once daily
11331682|NCT03482882|OG000|Outcome|Pimavanserin Full Analysis Set|The Full Analysis Set (FAS) includes all subjects (45 participants) who received at least one dose of study drug (34mg pimavanserin taken as two 17mg tablets, once daily by mouth) and who have both a baseline value and post-baseline value for the Hamilton Depression Scales (17 items; HAMD-17)
11331683|NCT03482882|EG000|Reported Event|Pimavanserin|Pimavanserin 34 mg, taken as 2 tablets of pimavanserin 17 mg as a single dose once daily
11331684|NCT03482973|BG000|Baseline|Interventional Bupivacaine|"20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1~Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331685|NCT03482973|BG001|Baseline|Interventional Placebo|"20 cc of saline on each side of the sternum at two time points after surgery and POD1~Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331686|NCT03482973|BG002|Baseline|Total|Total of all reporting groups
11331687|NCT03482973|FG000|Participant Flow|Interventional Bupivacaine|"20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1~Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331688|NCT03482973|FG001|Participant Flow|Interventional Placebo|"20 cc of saline on each side of the sternum at two time points after surgery and POD1~Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331689|NCT03482973|OG000|Outcome|Interventional Bupivacaine|"20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1~Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331690|NCT03482973|OG001|Outcome|Interventional Placebo|"20 cc of saline on each side of the sternum at two time points after surgery and POD1~Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1)."
10842344|NCT00246025|FG003|Participant Flow|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
11331691|NCT03482973|EG000|Reported Event|Interventional Bupivacaine|"20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1~Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331692|NCT03482973|EG001|Reported Event|Interventional Placebo|"20 cc of saline on each side of the sternum at two time points after surgery and POD1~Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1)."
11331693|NCT03483506|BG000|Baseline|BI 1467335|All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg [C-14] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg [C-14] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
11331694|NCT03483506|FG000|Participant Flow|BI 1467335|All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg [C-14] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg [C-14] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
11331695|NCT03483506|OG000|Outcome|BI 1467335 Tab|Participant were administered 2 film-coated tablets of 5 mg (2*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).
11331696|NCT03483506|OG001|Outcome|BI 1467335 (C-14) iv|Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
11331697|NCT03483506|OG000|Outcome|BI 1467335 (C-14) iv|Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
11331698|NCT03483506|EG000|Reported Event|BI 1467335|All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg [C-14] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg [C-14] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
11331699|NCT03483623|BG000|Baseline|North Atlantic Treaty Organization (NATO) and Warrior Evacuati|Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations. Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 and Doppler measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations
11331700|NCT03483623|FG000|Participant Flow|NATO WELP/ NATO FIS / RAVEN WELP / RAVEN FIS|"Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations~Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 and Doppler measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations."
11331701|NCT03483623|OG000|Outcome|North Atlantic Treaty Organization (NATO) and Warrior Evacuati|Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations. Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 and Doppler measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations
11331702|NCT03483623|EG000|Reported Event|North Atlantic Treaty Organization (NATO) and Warrior Evacuati|Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations. Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 and Doppler measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations
11331703|NCT03483675|BG000|Baseline|Arm I (Discontinued IST)|Participants have their IST tapered and discontinued per the plan.
10842345|NCT00246025|OG000|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
11331704|NCT03483675|BG001|Baseline|Arm II (Continued IST)|Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
11331705|NCT03483675|BG002|Baseline|Total|Total of all reporting groups
11331706|NCT03483675|FG000|Participant Flow|Arm I (Discontinued IST)|Participants have their IST tapered and discontinued per the plan.
11331707|NCT03483675|FG001|Participant Flow|Arm II (Continued IST)|Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
11331708|NCT03483675|OG000|Outcome|Total Number of Participants|Total number of participants who signed consent
11331709|NCT03483675|OG000|Outcome|Arm I (Discontinued IST)|Participants have their IST tapered and discontinued per the plan.
11331710|NCT03483675|OG001|Outcome|Arm II (Continued IST)|Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
11331711|NCT03483675|EG000|Reported Event|Arm I (Discontinued IST)|"Participants have their IST tapered and discontinued per the plan.~Immunosuppressive Therapy: Discontinued IST~Survey Administration: Ancillary studies"
11331712|NCT03483675|EG001|Reported Event|Arm II (Continued IST)|"Participants continue to receive a fixed dose IST for an additional 9 months with no taper.~Immunosuppressive Therapy: Continued IST~Survey Administration: Ancillary studies"
11331713|NCT03483896|BG000|Baseline|Control|At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions.
11331714|NCT03483896|BG001|Baseline|Daylight Intervention|"At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.~Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study."
11331715|NCT03483896|BG002|Baseline|Total|Total of all reporting groups
11331716|NCT03483896|FG000|Participant Flow|Control|At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions.
11331717|NCT03483896|FG001|Participant Flow|Daylight Intervention|"At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.~Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study."
11331718|NCT03483896|OG000|Outcome|Control|At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions.
11331719|NCT03483896|OG001|Outcome|Daylight Intervention|"At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.~Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study."
11331720|NCT03483896|EG000|Reported Event|Control|At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions.
11331721|NCT03483896|EG001|Reported Event|Daylight Intervention|"At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.~Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study."
11331722|NCT03483935|BG000|Baseline|Dose Finding Population|Consented participants had the electric properties of permittivity in AK on hand and bald scalp assessed for subsequent optimisation of the dose of microwave therapy to be used in the RCT.
11331723|NCT03483935|BG001|Baseline|RCT Study Population|"This was a randomized, internally controlled, feasibility study. Consented participants had the treatment site (scalp/forehead or hands) selected based on a clinical decision. Participants were randomized to treatment to the left or right side.~The microwave treatment was delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for this indication. The microwave dose was between 2 Watt and 4 Watt. The treatment will consist of 3, 2 to 3 second bursts delivered to the same lesion with 5-20 seconds between bursts.~No treatment was administered to the control side."
11331724|NCT03483935|BG002|Baseline|Total|Total of all reporting groups
11331725|NCT03483935|FG000|Participant Flow|Trial Population|Stage 1: Determine the electrical properties of AKs Stage 2: Evaluate the efficacy of microwave energy as a treatment for AK
11331726|NCT03483935|OG000|Outcome|Microwave Energy Treatment|Microwave dose for participants 1 and 2 was 5 Watt. Dose for participants 3 through 9 was between 2 Watt and 4 Watt. Treatment consists of 3, 2 to 3 second bursts of microwave energy, delivered to the same lesion with 5-20 seconds between bursts.
11331727|NCT03483935|OG001|Outcome|Control|No treatment
11331728|NCT03483935|OG000|Outcome|Treatment 1|First microwave treatment, administered at visit 1, day 1
11331729|NCT03483935|OG001|Outcome|Treatment 2|Second microwave treatment, administered at visit 6, day 28
11331730|NCT03483935|EG000|Reported Event|Stage 1 Dose Finding Study|To determine the electrical properties of permitivity in AK on the hand and scalp.
11331731|NCT03483935|EG001|Reported Event|Stage 2 RCT|The microwave treatment delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for this indication. The microwave dose was between 5 Watt for the first two participants and 2 Watt and 4 Watt for the remaining nine participants. The treatment will consist of 3, 2 to 3 second bursts delivered to the same lesion with 5-20 seconds between bursts.
11331732|NCT03483961|BG000|Baseline|Group 1: 20 mcg/Unadjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)~CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens~Placebo: Placebo is vaccine diluent alone"
11331733|NCT03483961|BG001|Baseline|Group 2: 6 mcg/Adjuvant (Day 1 & 29)|"6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331734|NCT03483961|BG002|Baseline|Group 3: 10 mcg/Adjuvant (Day 1 & 29)|"10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331735|NCT03483961|BG003|Baseline|Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331736|NCT03483961|BG004|Baseline|Group 5: 6 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331737|NCT03483961|BG005|Baseline|Group 6: 10 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331738|NCT03483961|BG006|Baseline|Group 7: 20 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331739|NCT03483961|BG007|Baseline|Group 8: 40 mcg/Adjuvant (Day 29)|"Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331740|NCT03483961|BG008|Baseline|Group 9: 20 mcg/Adjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331741|NCT03483961|BG009|Baseline|Group 10: 40 mcg/Adjuvant (Day 1)|"40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331742|NCT03483961|BG010|Baseline|Total|Total of all reporting groups
11331743|NCT03483961|FG000|Participant Flow|Group 1: 20 mcg/Unadjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)~CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens~Placebo: Placebo is vaccine diluent alone"
11331744|NCT03483961|FG001|Participant Flow|Group 2: 6 mcg/Adjuvant (Day 1 & 29)|"6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331745|NCT03483961|FG002|Participant Flow|Group 3: 10 mcg/Adjuvant (Day 1 & 29)|"10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331746|NCT03483961|FG003|Participant Flow|Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331747|NCT03483961|FG004|Participant Flow|Group 5: 6 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331748|NCT03483961|FG005|Participant Flow|Group 6: 10 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331749|NCT03483961|FG006|Participant Flow|Group 7: 20 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331750|NCT03483961|FG007|Participant Flow|Group 8: 40 mcg/Adjuvant (Day 29)|"Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331751|NCT03483961|FG008|Participant Flow|Group 9: 20 mcg/Adjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331752|NCT03483961|FG009|Participant Flow|Group 10: 40 mcg/Adjuvant (Day 1)|"40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331753|NCT03483961|OG000|Outcome|Group 1: 20 mcg/Unadjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)~CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens~Placebo: Placebo is vaccine diluent alone"
11331754|NCT03483961|OG001|Outcome|Group 2: 6 mcg/Adjuvant (Day 1 & 29)|"6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331755|NCT03483961|OG002|Outcome|Group 3: 10 mcg/Adjuvant (Day 1 & 29)|"10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331756|NCT03483961|OG003|Outcome|Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331757|NCT03483961|OG004|Outcome|Group 5: 6 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331758|NCT03483961|OG005|Outcome|Group 6: 10 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331759|NCT03483961|OG006|Outcome|Group 7: 20 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331760|NCT03483961|OG007|Outcome|Group 8: 40 mcg/Adjuvant (Day 29)|"Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331761|NCT03483961|OG000|Outcome|Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331762|NCT03483961|EG000|Reported Event|Group 1: 20 mcg/Unadjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)~CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens~Placebo: Placebo is vaccine diluent alone"
11331763|NCT03483961|EG001|Reported Event|Group 2: 6 mcg/Adjuvant (Day 1 & 29)|"6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331764|NCT03483961|EG002|Reported Event|Group 3: 10 mcg/Adjuvant (Day 1 & 29)|"10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331765|NCT03483961|EG003|Reported Event|Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331766|NCT03483961|EG004|Reported Event|Group 5: 6 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331767|NCT03483961|EG005|Reported Event|Group 6: 10 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331768|NCT03483961|EG006|Reported Event|Group 7: 20 mcg/Adjuvant (Day 15 & 29)|"Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331769|NCT03483961|EG007|Reported Event|Group 8: 40 mcg/Adjuvant (Day 29)|"Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel~Placebo: Placebo is vaccine diluent alone"
11331770|NCT03483961|EG008|Reported Event|Group 9: 20 mcg/Adjuvant (Day 1 & 29)|"20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331771|NCT03483961|EG009|Reported Event|Group 10: 40 mcg/Adjuvant (Day 1)|"40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.~CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel"
11331772|NCT03484273|BG000|Baseline|Full Compression|"The LifeWrap compression garment will be fully secured with all straps.~LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures."
11331773|NCT03484273|FG000|Participant Flow|4 Compression Interventions in Randomized Order|Participants completed all 4 compression garment interventions in a random order. There were a total of 24 possible intervention orders. The 4 compression interventions were: Full Compression, Abdominal and Pelvic Compression, Lower Limb Compression and No Compression.
11331774|NCT03484273|OG000|Outcome|Full Compression|"The LifeWrap compression garment will be fully secured with all straps.~LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures."
11331775|NCT03484273|OG001|Outcome|Abdominal and Pelvic Compression|The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.
11331776|NCT03484273|OG002|Outcome|Lower Limb Compression|The Lifewrap compression garment calf and ankle straps only will be secured.
11331777|NCT03484273|OG003|Outcome|No Compression|None of the LifeWrap compression garment straps will be secured.
11331778|NCT03484273|OG001|Outcome|Abdominal and Pelvic Compression|"The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.~LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures."
11331779|NCT03484273|OG002|Outcome|Lower Limb Compression|"The Lifewrap compression garment calf and ankle straps only will be secured.~LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures."
11331780|NCT03484273|EG000|Reported Event|Full Compression|"The LifeWrap compression garment will be fully secured with all straps.~LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures."
11331781|NCT03484273|EG001|Reported Event|Abdominal and Pelvic Compression|The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.
11331782|NCT03484273|EG002|Reported Event|Lower Limb Compression|The Lifewrap compression garment calf and ankle straps only will be secured.
11331783|NCT03484273|EG003|Reported Event|No Compression|None of the LifeWrap compression garment straps will be secured.
11331784|NCT03484429|BG000|Baseline|Peripheral Nerve Stimulation (PNS)|Up to 60 days of PNS starting within 7 days after major lower limb amputation surgery. Subjects also received standard medical therapy (SMT). SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331785|NCT03484429|BG001|Baseline|Control|Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331786|NCT03484429|BG002|Baseline|Total|Total of all reporting groups
11331787|NCT03484429|FG000|Participant Flow|Peripheral Nerve Stimulation (PNS)|"Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery~Peripheral nerve stimulation: Up to 60 days of peripheral nerve stimulation~Standard Medical Therapy: Medications, physical therapy, or other pain treatments"
11331788|NCT03484429|FG001|Participant Flow|Standard Medical Therapy (SMT)|"Standard medical therapy only~Standard Medical Therapy: Medications, physical therapy, or other pain treatments"
11331789|NCT03484429|OG000|Outcome|Peripheral Nerve Stimulation (PNS)|Up to 60 days of PNS starting within 7 days after major lower limb amputation surgery. Subjects also received standard medical therapy (SMT). SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331790|NCT03484429|OG001|Outcome|Control|Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331791|NCT03484429|EG000|Reported Event|Peripheral Nerve Stimulation (PNS)|Up to 60 days of PNS starting within 7 days after major lower limb amputation surgery. Subjects also received standard medical therapy (SMT). SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331792|NCT03484429|EG001|Reported Event|Control|Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
11331793|NCT03485222|BG000|Baseline|Empagliflozin|10mg once a day for 6 months
11331794|NCT03485222|BG001|Baseline|Placebos|Placebo equivalent once a day for 6 months
11331795|NCT03485222|BG002|Baseline|Total|Total of all reporting groups
11331796|NCT03485222|FG000|Participant Flow|Empagliflozin|10mg once a day for 6 months
11331797|NCT03485222|FG001|Participant Flow|Placebos|Placebo equivalent once a day for 6 months
11331798|NCT03485222|OG000|Outcome|Empagliflozin|10mg once a day for 6 months
11331799|NCT03485222|OG001|Outcome|Placebos|Placebo equivalent once a day for 6 months
11331800|NCT03485222|EG000|Reported Event|Empagliflozin|10mg once a day for 6 months
11331801|NCT03485222|EG001|Reported Event|Placebos|Placebo equivalent once a day for 6 months
11331802|NCT03485495|BG000|Baseline|Divaza|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Divaza: Oral administration."
11331803|NCT03485495|BG001|Baseline|Placebo|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Placebo: Oral administration."
11331804|NCT03485495|BG002|Baseline|Total|Total of all reporting groups
11331805|NCT03485495|FG000|Participant Flow|Divaza|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Divaza: Oral administration."
11331806|NCT03485495|FG001|Participant Flow|Placebo|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Placebo: Oral administration."
11331807|NCT03485495|OG000|Outcome|Divaza|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Divaza: Oral administration."
11331808|NCT03485495|OG001|Outcome|Placebo|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Placebo: Oral administration."
11331809|NCT03485495|EG000|Reported Event|Divaza|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Divaza: Oral administration."
11331810|NCT03485495|EG001|Reported Event|Placebo|"Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.~Placebo: Oral administration."
11331811|NCT03485976|BG000|Baseline|Ixekizumab Treatment Arm|"Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20~Ixekizumab: Treatment at the FDA-approved psoriasis dosing"
11331812|NCT03485976|FG000|Participant Flow|Ixekizumab Treatment Arm|"Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20~Ixekizumab: Treatment at the FDA-approved psoriasis dosing"
11331813|NCT03485976|OG000|Outcome|Ixekizumab Treatment Arm|"Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20~Ixekizumab: Treatment at the FDA-approved psoriasis dosing"
11331814|NCT03485976|EG000|Reported Event|Ixekizumab Treatment Arm|"Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20~Ixekizumab: Treatment at the FDA-approved psoriasis dosing"
11331815|NCT03486392|BG000|Baseline|Double Blind: Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331816|NCT03486392|BG001|Baseline|Double Blind: JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331817|NCT03486392|BG002|Baseline|Double Blind: JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331818|NCT03486392|BG003|Baseline|Double Blind: JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331819|NCT03486392|BG004|Baseline|Open Label: Liraglutide 3.0 mg|Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
11331820|NCT03486392|BG005|Baseline|Total|Total of all reporting groups
11331821|NCT03486392|FG000|Participant Flow|Double Blind: Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331822|NCT03486392|FG001|Participant Flow|Double Blind: JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331823|NCT03486392|FG002|Participant Flow|Double Blind: JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331824|NCT03486392|FG003|Participant Flow|Double Blind: JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331825|NCT03486392|FG004|Participant Flow|Open Label: Liraglutide 3.0 mg|Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
11331826|NCT03486392|OG000|Outcome|Double Blind: Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331827|NCT03486392|OG001|Outcome|Double Blind: JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331828|NCT03486392|OG002|Outcome|Double Blind: JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331829|NCT03486392|OG003|Outcome|Double Blind: JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331830|NCT03486392|OG004|Outcome|Open Label: Liraglutide 3.0 mg|Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
11331831|NCT03486392|EG000|Reported Event|Double Blind: Placebo|Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331832|NCT03486392|EG001|Reported Event|Double Blind: JNJ-64565111 5.0 mg|Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331833|NCT03486392|EG002|Reported Event|Double Blind: JNJ-64565111 7.4 mg|Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331834|NCT03486392|EG003|Reported Event|Double Blind: JNJ-64565111 10.0 mg|Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
11331835|NCT03486392|EG004|Reported Event|Open Label: Liraglutide 3.0 mg|Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
11331836|NCT03486834|BG000|Baseline|V160 3-Dose Regimen|Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
11331837|NCT03486834|BG001|Baseline|V160 2-Dose Regimen|Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
11331838|NCT03486834|BG002|Baseline|Placebo|Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
11331839|NCT03486834|BG003|Baseline|Total|Total of all reporting groups
11331840|NCT03486834|FG000|Participant Flow|V160 3-Dose Regimen|Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
11331841|NCT03486834|FG001|Participant Flow|V160 2-Dose Regimen|Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
11331842|NCT03486834|FG002|Participant Flow|Placebo|Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
11331843|NCT03486834|OG000|Outcome|V160 3-Dose Regimen|Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
11331844|NCT03486834|OG001|Outcome|Placebo|Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
11331845|NCT03486834|OG001|Outcome|V160 2-Dose Regimen|Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
11331846|NCT03486834|OG002|Outcome|Placebo|Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
11331847|NCT03486834|OG000|Outcome|V160 2-Dose Regimen|Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
11331848|NCT03486834|EG000|Reported Event|V160 3-Dose Group|Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
11331849|NCT03486834|EG001|Reported Event|V160 2-Dose Group|Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
11331850|NCT03486834|EG002|Reported Event|Placebo Group|Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
11331851|NCT03486990|BG000|Baseline|Part A, Cohort 1: 0.1 mg/kg|TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
11331852|NCT03486990|BG001|Baseline|Part A, Cohort 2: 0.5 mg/kg|TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
11331853|NCT03486990|BG002|Baseline|Part A, Cohort 3: 1.0 mg/kg|TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
11331854|NCT03486990|BG003|Baseline|Part A, Cohort 4: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
11331855|NCT03486990|BG004|Baseline|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331856|NCT03486990|BG005|Baseline|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331857|NCT03486990|BG006|Baseline|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331858|NCT03486990|BG007|Baseline|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331859|NCT03486990|BG008|Baseline|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331860|NCT03486990|BG009|Baseline|Total|Total of all reporting groups
11331861|NCT03486990|FG000|Participant Flow|Part A, Cohort 1: 0.1 mg/kg|TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
11331862|NCT03486990|FG001|Participant Flow|Part A, Cohort 2: 0.5 mg/kg|TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
11331863|NCT03486990|FG002|Participant Flow|Part A, Cohort 3: 1.0 mg/kg|TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
11331864|NCT03486990|FG003|Participant Flow|Part A, Cohort 4: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
11331865|NCT03486990|FG004|Participant Flow|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331866|NCT03486990|FG005|Participant Flow|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331867|NCT03486990|FG006|Participant Flow|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331868|NCT03486990|FG007|Participant Flow|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331869|NCT03486990|FG008|Participant Flow|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331870|NCT03486990|OG000|Outcome|Part A, Cohort 1: 0.1 mg/kg|TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
11331871|NCT03486990|OG001|Outcome|Part A, Cohort 2: 0.5 mg/kg|TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
11331872|NCT03486990|OG002|Outcome|Part A, Cohort 3: 1.0 mg/kg|TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
11331873|NCT03486990|OG003|Outcome|Part A, Cohort 4: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
11331874|NCT03486990|OG004|Outcome|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331875|NCT03486990|OG005|Outcome|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331876|NCT03486990|OG006|Outcome|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331877|NCT03486990|OG007|Outcome|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331878|NCT03486990|OG008|Outcome|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331879|NCT03486990|OG000|Outcome|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331880|NCT03486990|OG001|Outcome|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331881|NCT03486990|OG002|Outcome|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331882|NCT03486990|OG000|Outcome|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331883|NCT03486990|OG001|Outcome|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331884|NCT03486990|OG002|Outcome|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331885|NCT03486990|OG003|Outcome|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331886|NCT03486990|OG004|Outcome|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331887|NCT03486990|OG000|Outcome|Part A, Cohort 2: 0.5 mg/kg|TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
11331888|NCT03486990|OG001|Outcome|Part A, Cohort 3: 1.0 mg/kg|TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
11331889|NCT03486990|OG002|Outcome|Part A, Cohort 4: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
11331890|NCT03486990|OG003|Outcome|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331891|NCT03486990|OG004|Outcome|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331892|NCT03486990|OG005|Outcome|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331893|NCT03486990|OG006|Outcome|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331894|NCT03486990|OG007|Outcome|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331895|NCT03486990|EG000|Reported Event|Part A, Cohort 1: 0.1 mg/kg|TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
11331896|NCT03486990|EG001|Reported Event|Part A, Cohort 2: 0.5 mg/kg|TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
11331897|NCT03486990|EG002|Reported Event|Part A, Cohort 3: 1.0 mg/kg|TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
11331898|NCT03486990|EG003|Reported Event|Part A, Cohort 4: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
11331899|NCT03486990|EG004|Reported Event|Part A, Cohort 5: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
11331900|NCT03486990|EG005|Reported Event|Part A, Cohort 6: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
11331901|NCT03486990|EG006|Reported Event|Part B, Cohort 1: 2.0 mg/kg|TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331902|NCT03486990|EG007|Reported Event|Part B, Cohort 2: 4.0 mg/kg|TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331903|NCT03486990|EG008|Reported Event|Part B, Cohort 3: 8.0 mg/kg|TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
11331904|NCT03487276|BG000|Baseline|Cohort 1|"Placebo~Placebo: Placebo"
11331905|NCT03487276|BG001|Baseline|Cohort 2|"Minimum Dose IFX-1~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331906|NCT03487276|BG002|Baseline|Cohort 3|"Low dose IFX-1~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331907|NCT03487276|BG003|Baseline|Cohort 4|"Medium Dose IFX-1~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331908|NCT03487276|BG004|Baseline|Cohort 5|"High Dose IFX-1~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331909|NCT03487276|BG005|Baseline|Total|Total of all reporting groups
11331910|NCT03487276|FG000|Participant Flow|Cohort 1|"Placebo~Placebo: Placebo"
11331911|NCT03487276|FG001|Participant Flow|Cohort 2|"Minimum Dose IFX-1 (400 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331912|NCT03487276|FG002|Participant Flow|Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331913|NCT03487276|FG003|Participant Flow|Cohort 4|"Medium Dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331914|NCT03487276|FG004|Participant Flow|Cohort 5|"High Dose IFX-1 (1200 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331915|NCT03487276|OG000|Outcome|Cohort 1|"Placebo~Placebo: Placebo"
11331916|NCT03487276|OG001|Outcome|Cohort 2|"Minimum Dose IFX-1 (400 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331917|NCT03487276|OG002|Outcome|Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331918|NCT03487276|OG003|Outcome|Cohort 4|"Medium Dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331919|NCT03487276|OG004|Outcome|Cohort 5|"High Dose IFX-1 (1200 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331920|NCT03487276|OG000|Outcome|Main Period: Cohort 1|"Placebo~Placebo: Placebo"
11331921|NCT03487276|OG001|Outcome|Main Period: Cohort 2|"Minimum Dose IFX-1 (400 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331922|NCT03487276|OG002|Outcome|Main Period: Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331923|NCT03487276|OG003|Outcome|Main Period: Cohort 4|"Medium Dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331924|NCT03487276|OG004|Outcome|Main Period: Cohort 5|"High Dose IFX-1 (1200 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331925|NCT03487276|OG005|Outcome|Extension Period: Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331926|NCT03487276|OG006|Outcome|Extension Period: Cohort 4|"Low dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331927|NCT03487276|EG000|Reported Event|Main Period: Cohort 1|"Placebo~Placebo: Placebo"
11331928|NCT03487276|EG001|Reported Event|Main Period: Cohort 2|"Minimum Dose IFX-1 (400 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331929|NCT03487276|EG002|Reported Event|Main Period: Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331930|NCT03487276|EG003|Reported Event|Main Period: Cohort 4|"Medium Dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331931|NCT03487276|EG004|Reported Event|Main Period: Cohort 5|"High Dose IFX-1 (1200 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331932|NCT03487276|EG005|Reported Event|Extension Period: Cohort 3|"Low dose IFX-1 (800 mg Q4W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331933|NCT03487276|EG006|Reported Event|Extension Period: Cohort 4|"Medium Dose IFX-1 (800 mg Q2W)~IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride."
11331934|NCT03487445|BG000|Baseline|Selatogrel 8 mg|A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331935|NCT03487445|BG001|Baseline|Selatogrel 16 mg|A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331936|NCT03487445|BG002|Baseline|Total|Total of all reporting groups
11331937|NCT03487445|FG000|Participant Flow|Selatogrel 8 mg|A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331938|NCT03487445|FG001|Participant Flow|Selatogrel 16 mg|A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331939|NCT03487445|OG000|Outcome|Selatogrel 8 mg|A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331940|NCT03487445|OG001|Outcome|Selatogrel 16 mg|A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331941|NCT03487445|EG000|Reported Event|Selatogrel 8 mg|A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331942|NCT03487445|EG001|Reported Event|Selatogrel 16 mg|A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
11331943|NCT03487549|BG000|Baseline|VP-102 - Cohort 1|"Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.~Utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed.~VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 14 days between treatments.~VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device."
11331944|NCT03487549|BG001|Baseline|VP-102 - Cohort 2|"Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.~Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed.~VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21days between treatments.~VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device."
11331945|NCT03487549|BG002|Baseline|Total|Total of all reporting groups
11331946|NCT03487549|FG000|Participant Flow|Cohort 1|Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
11331947|NCT03487549|FG001|Participant Flow|Cohort 2|Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed. Subjects were 12 years and older.
11331948|NCT03487549|OG000|Outcome|Cohort 1|Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
11331949|NCT03487549|OG000|Outcome|VP-102 - Cohort 2|"Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.~Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed.~VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments.~VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device."
11331950|NCT03487549|EG000|Reported Event|Cohort 1|Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
11331951|NCT03487549|EG001|Reported Event|Cohort 2|Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. Subjects were 12 years and older.
11331952|NCT03487588|BG000|Baseline|A-101 Topical Solution|"Open Label Arm~A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29"
11331953|NCT03487588|FG000|Participant Flow|A-101 Topical Solution|"Open Label Arm~A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29"
11331954|NCT03487588|OG000|Outcome|A-101 Topical Solution|"Open Label Arm~A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29"
11331955|NCT03487588|EG000|Reported Event|A-101 Topical Solution|"Open Label Arm~A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29"
11331956|NCT03487718|BG000|Baseline|Control Group|"Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.~d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane"
11331957|NCT03487718|BG001|Baseline|Test Group|"Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.~Leukocyte platelet rich fibrin plug + d-PTFE membrane: Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane"
11331958|NCT03487718|BG002|Baseline|Total|Total of all reporting groups
11331959|NCT03487718|FG000|Participant Flow|Control Group|"Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.~d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane"
11331960|NCT03487718|FG001|Participant Flow|Test Group|"Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.~Leukocyte platelet rich fibrin plug + d-PTFE membrane: Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane"
11331961|NCT03487718|OG000|Outcome|Control Group|"Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.~d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane"
11336279|NCT03565068|FG004|Participant Flow|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg|In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
11331962|NCT03487718|OG001|Outcome|Test Group|"Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.~Leukocyte platelet rich fibrin plug + d-PTFE membrane: Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane"
11331963|NCT03487718|EG000|Reported Event|Control Group|"Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.~d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane"
11331964|NCT03487718|EG001|Reported Event|Test Group|"Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.~Leukocyte platelet rich fibrin plug + d-PTFE membrane: Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane"
11331965|NCT03487848|BG000|Baseline|Daclatasvir (DCV) + Sofosbuvir (SOF)|DCV 60 mg QD + SOF 400 mg QD for 12 weeks
11331966|NCT03487848|FG000|Participant Flow|Daclatasvir (DCV) + Sofosbuvir (SOF)|DCV 60 mg QD + SOF 400 mg QD for 12 weeks
11331967|NCT03487848|OG000|Outcome|Daclatasvir (DCV) + Sofosbuvir (SOF)|DCV 60 mg QD + SOF 400 mg QD for 12 weeks
11331968|NCT03487848|EG000|Reported Event|Daclatasvir (DCV) + Sofosbuvir (SOF)|DCV 60 mg QD + SOF 400 mg QD for 12 weeks
11331969|NCT03488108|BG000|Baseline|Platelet Rich Plasma First, Then Minoxidil Foam|"Subjects who received PRP in either the first or last 12 weeks of the study~Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.~Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.~Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks."
11331970|NCT03488108|BG001|Baseline|Minoxidil Foam First, Then Platelet Rich Plasma|"Subjects who received Minoxidil either the first or last 12 weeks of the study~Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.~Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.~Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks."
11331971|NCT03488108|BG002|Baseline|Total|Total of all reporting groups
11331972|NCT03488108|FG000|Participant Flow|Platelet Rich Plasma First, Then Minoxidil Foam|"Subjects who received PRP in either the first or last 12 weeks of the study~Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.~Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.~Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks."
11331973|NCT03488108|FG001|Participant Flow|Minoxidil Foam First, Then Platelet Rich Plasma|"Subjects who received Minoxidil either the first or last 12 weeks of the study~Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.~Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.~Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks."
11331974|NCT03488108|OG000|Outcome|Platelet Rich Plasma|Subjects who received PRP in either the first or last 12 weeks of the study.
11331975|NCT03488108|OG001|Outcome|Minoxidil Foam|Subjects who received Minoxidil either the first or last 12 weeks of the study.
11331976|NCT03488108|OG000|Outcome|Platelet Rich Plasma|Subjects who received PRP in either the first or last 12 weeks of the study
11331977|NCT03488108|OG001|Outcome|Minoxidil Foam|Subjects who received Minoxidil either the first or last 12 weeks of the study
11331978|NCT03488108|EG000|Reported Event|Platelet Rich Plasma|"Subjects who received PRP in either the first or last 12 weeks of the study~Platelet Rich Plasma: Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks."
11331979|NCT03488108|EG001|Reported Event|Minoxidil Foam|"Subjects who received Minoxidil either the first or last 12 weeks of the study~Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks."
11331980|NCT03488225|BG000|Baseline|Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)|"See detailed description.~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Inotuzumab Ozogamicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IT, IV or PO~Ofatumumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11331981|NCT03488225|FG000|Participant Flow|Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)|"See detailed description.~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Inotuzumab Ozogamicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IT, IV or PO~Ofatumumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11331982|NCT03488225|OG000|Outcome|Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)|"See detailed description.~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Inotuzumab Ozogamicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IT, IV or PO~Ofatumumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11331983|NCT03488225|EG000|Reported Event|Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)|"See detailed description.~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Inotuzumab Ozogamicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Mercaptopurine: Given PO~Methotrexate: Given IT, IV or PO~Ofatumumab: Given IV~Prednisone: Given PO~Rituximab: Given IV~Vincristine Sulfate: Given IV"
11331984|NCT03488238|BG000|Baseline|ORi Sensor|"All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure~ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi"
11331985|NCT03488238|FG000|Participant Flow|ORi Sensor|"All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure~ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi"
11331986|NCT03488238|OG000|Outcome|ORi Sensor|"All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure~ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi"
11331987|NCT03488238|EG000|Reported Event|ORi Sensor|"All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure~ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi"
11331988|NCT03488849|BG000|Baseline|SureCRIC|"SureCRIC-aided cricothyroid membrane identification~SureCRIC: SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway."
11331989|NCT03488849|BG001|Baseline|Freehand|"Freehand cricothyroid membrane identification~Freehand: Freehand palpation approach to identification of the cricothyroid membrane"
11331990|NCT03488849|BG002|Baseline|Standardized Patients|Healthy male and female volunteers corresponding to the 5th, 50th and 95th percentile heights.
11331991|NCT03488849|BG003|Baseline|Total|Total of all reporting groups
11331992|NCT03488849|FG000|Participant Flow|SureCRIC|"SureCRIC-aided cricothyroid membrane identification~SureCRIC: SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway."
11331993|NCT03488849|FG001|Participant Flow|Freehand|"Freehand cricothyroid membrane identification~Freehand: Freehand palpation approach to identification of the cricothyroid membrane"
11331994|NCT03488849|FG002|Participant Flow|Standardized Patients|Healthy males and females representing the <10th, 50th and >90th percentile heights.
11331995|NCT03488849|OG000|Outcome|SureCRIC|"SureCRIC-aided cricothyroid membrane identification~SureCRIC: SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway."
11331996|NCT03488849|OG001|Outcome|Freehand|"Freehand cricothyroid membrane identification~Freehand: Freehand palpation approach to identification of the cricothyroid membrane"
11331997|NCT03488849|OG002|Outcome|Standardized Patient|Healthy volunteers - males and females corresponding to the 5th, 50th, and 95th percentile heights
11331998|NCT03488849|EG000|Reported Event|SureCRIC|"SureCRIC-aided cricothyroid membrane identification~SureCRIC: SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway."
11331999|NCT03488849|EG001|Reported Event|Freehand|"Freehand cricothyroid membrane identification~Freehand: Freehand palpation approach to identification of the cricothyroid membrane"
11332000|NCT03488849|EG002|Reported Event|Standardized Patients|Healthy volunteers corresponding to the <10th, 50th and >90th percentile heights.
11332001|NCT03488927|BG000|Baseline|Intervention-Attend|"This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation.~Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS): The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims."
11332002|NCT03488927|BG001|Baseline|Wait-list Control|This arm was be invited to attend the intervention after a six-month follow-up evaluation.
11332003|NCT03488927|BG002|Baseline|Intervention-Nonattend|This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
11332004|NCT03488927|BG003|Baseline|Total|Total of all reporting groups
11333854|NCT03520920|FG000|Participant Flow|Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma|Participants with relapsed/refractory (R/R) non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 milligrams (mg) orally (PO) twice daily (BID) continuously and rituximab 375 mg/meter squared (m^2) intravenously (IV) on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
11333855|NCT03520920|FG001|Participant Flow|Relapsed/Refractory Follicular Lymphoma|Participants with R/R follicular lymphoma (FL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
10842346|NCT00246025|OG001|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
10842347|NCT00246025|OG002|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
10842348|NCT00246025|OG003|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
10842349|NCT00246025|EG000|Reported Event|Treatment Group With Placebo|Patients were treated with matching Placebo.
10842350|NCT00246025|EG001|Reported Event|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
10842351|NCT00246025|EG002|Reported Event|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
10842352|NCT00246025|EG003|Reported Event|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
10842353|NCT00246090|BG000|Baseline|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
10842354|NCT00246090|FG000|Participant Flow|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
10842355|NCT00246090|OG000|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
10842356|NCT00246090|EG000|Reported Event|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
10842357|NCT00246129|BG000|Baseline|Campath-Tacrolimus|Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy
10842358|NCT00246129|BG001|Baseline|Daclizumab-Tacrolimus-Mycophenolate|Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
10842359|NCT00246129|BG002|Baseline|Total|Total of all reporting groups
10842360|NCT00246129|FG000|Participant Flow|Campath-Tacrolimus|Campath (1x30mg) induction with 7-day short-course steroids followed by tacrolimus monotherapy (dose adjusted to target trough level 9-11ng/ml)
10842361|NCT00246129|FG001|Participant Flow|Daclizumab-Tacrolimus-Mycophenolate|Daclizumab 2mg/kg x2 days 0+14) induction with 7-day short-course steroids followed by Tacrolimus (adjusted to target trough 9-11ng/ml) and Mycophenolate mofetil therapy (750mg bd)
10842362|NCT00246129|OG000|Outcome|Campath-Tacrolimus|Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy
10842363|NCT00246129|OG001|Outcome|Daclizumab-Tacrolimus-Mycophenolate|Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
10842364|NCT00246129|OG000|Outcome|Campath Tacrolimus|Alemtuzumab induction with short-course steroids and Tacrolimus maintenance monotherapy
10842365|NCT00246129|OG001|Outcome|Daclizumab-Tacrolimus-Mycophenolate|
10842366|NCT00246129|OG000|Outcome|Campath Tacrolimus '|
10842367|NCT00246129|EG000|Reported Event|Campath-Tacrolimus|Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy
10842368|NCT00246129|EG001|Reported Event|Daclizumab-Tacrolimus-Mycophenolate|Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
10842369|NCT00246259|BG000|Baseline|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
10842370|NCT00246259|BG001|Baseline|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
10842371|NCT00246259|BG002|Baseline|Total|Total of all reporting groups
10842372|NCT00246259|FG000|Participant Flow|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
10842373|NCT00246259|FG001|Participant Flow|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
10842374|NCT00246259|OG000|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
10842375|NCT00246259|OG001|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
10842376|NCT00246259|EG000|Reported Event|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
10842377|NCT00246259|EG001|Reported Event|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
10842378|NCT00246324|BG000|Baseline|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
10842379|NCT00246324|FG000|Participant Flow|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
11332005|NCT03488927|FG000|Participant Flow|Intervention-Attend|"This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation.~Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS): The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims."
11332006|NCT03488927|FG001|Participant Flow|Wait-list Control|This arm was be invited to attend the intervention after a six-month follow-up evaluation.
11332007|NCT03488927|FG002|Participant Flow|Intervention-Nonattend|This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
11332008|NCT03488927|OG000|Outcome|Intervention-Attend|"This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation.~Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS): The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims."
11332009|NCT03488927|OG001|Outcome|Wait-list Control|This arm was be invited to attend the intervention after a six-month follow-up evaluation.
11332010|NCT03488927|OG002|Outcome|Intervention-Nonattend|This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
11332011|NCT03488927|EG000|Reported Event|Intervention-Attend|"This arm was invited to and attended the intervention, followed by a six-month follow-up evaluation.~Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS): The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims."
11332012|NCT03488927|EG001|Reported Event|Wait-list Control|This arm was be invited to attend the intervention after a six-month follow-up evaluation.
11332013|NCT03488927|EG002|Reported Event|Intervention-Nonattend|This aim was invited to but did not attend the intervention, and completed the same six-month follow-up evaluation.
11332014|NCT03489304|BG000|Baseline|Zaleplon|"Open-label zaleplon 5-10mg daily~Zaleplon: non-benzodiazepine hypnotic agent"
11332015|NCT03489304|FG000|Participant Flow|Zaleplon|"Open-label zaleplon 5-10mg daily~Zaleplon: non-benzodiazepine hypnotic agent"
11332016|NCT03489304|OG000|Outcome|Zaleplon|"Open-label zaleplon 5-10mg daily~Zaleplon: non-benzodiazepine hypnotic agent"
11332017|NCT03489304|EG000|Reported Event|Zaleplon|"Open-label zaleplon 5-10mg daily~Zaleplon: non-benzodiazepine hypnotic agent"
11332018|NCT03489343|BG000|Baseline|Sym023 0.03 mg/kg|Sym023 0.03 mg/kg intravenous infusion once every 2 weeks
11332019|NCT03489343|BG001|Baseline|Sym023 0.1 mg/kg|Sym023 0.1 mg/kg intravenous infusion once every 2 weeks
11332020|NCT03489343|BG002|Baseline|Sym023 0.3 mg/kg|Sym023 0.3 mg/kg intravenous infusion once every 2 weeks
11332021|NCT03489343|BG003|Baseline|Sym023 1.0 mg/kg|Sym023 1.0 mg/kg intravenous infusion once every 2 weeks
11332022|NCT03489343|BG004|Baseline|Sym023 3.0 mg/kg|Sym023 3.0 mg/kg intravenous infusion once every 2 weeks
11332023|NCT03489343|BG005|Baseline|Sym023 10.0 mg/kg|Sym023 10.0 mg/kg intravenous infusion once every 2 weeks
11332024|NCT03489343|BG006|Baseline|Sym023 20.0 mg/kg|Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
11332025|NCT03489343|BG007|Baseline|Total|Total of all reporting groups
11332026|NCT03489343|FG000|Participant Flow|Sym023 0.03 mg/kg|Sym023 0.03 mg/kg intravenous infusion once every 2 weeks
11332027|NCT03489343|FG001|Participant Flow|Sym023 0.1 mg/kg|Sym023 0.1 mg/kg intravenous infusion once every 2 weeks
11332028|NCT03489343|FG002|Participant Flow|Sym023 0.3 mg/kg|Sym023 0.3 mg/kg intravenous infusion once every 2 weeks
11332029|NCT03489343|FG003|Participant Flow|Sym023 1.0 mg/kg|Sym023 1.0 mg/kg intravenous infusion once every 2 weeks
11332030|NCT03489343|FG004|Participant Flow|Sym023 3.0 mg/kg|Sym023 3.0 mg/kg intravenous infusion once every 2 weeks
11332031|NCT03489343|FG005|Participant Flow|Sym023 10.0 mg/kg|Sym023 10.0 mg/kg intravenous infusion once every 2 weeks
11332032|NCT03489343|FG006|Participant Flow|Sym023 20.0 mg/kg|Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
11332033|NCT03489343|OG000|Outcome|Sym023 0.03 mg/kg|Sym023 0.03 mg/kg intravenous infusion once every 2 weeks
11332034|NCT03489343|OG001|Outcome|Sym023 0.1 mg/kg|Sym023 0.1 mg/kg intravenous infusion once every 2 weeks
11332035|NCT03489343|OG002|Outcome|Sym023 0.3 mg/kg|Sym023 0.3 mg/kg intravenous infusion once every 2 weeks
11332036|NCT03489343|OG003|Outcome|Sym023 1.0 mg/kg|Sym023 1.0 mg/kg intravenous infusion once every 2 weeks
11332037|NCT03489343|OG004|Outcome|Sym023 3.0 mg/kg|Sym023 3.0 mg/kg intravenous infusion once every 2 weeks
11332038|NCT03489343|OG005|Outcome|Sym023 10.0 mg/kg|Sym023 10.0 mg/kg intravenous infusion once every 2 weeks
11332039|NCT03489343|OG006|Outcome|Sym023 20.0 mg/kg|Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
11332040|NCT03489343|EG000|Reported Event|Sym023 0.03 mg/kg|Sym023 0.03 mg/kg intravenous infusion once every 2 weeks
11332041|NCT03489343|EG001|Reported Event|Sym023 0.1 mg/kg|Sym023 0.1 mg/kg intravenous infusion once every 2 weeks
11332042|NCT03489343|EG002|Reported Event|Sym023 0.3 mg/kg|Sym023 0.3 mg/kg intravenous infusion once every 2 weeks
11332043|NCT03489343|EG003|Reported Event|Sym023 1.0 mg/kg|Sym023 1.0 mg/kg intravenous infusion once every 2 weeks
11332044|NCT03489343|EG004|Reported Event|Sym023 3.0 mg/kg|Sym023 3.0 mg/kg intravenous infusion once every 2 weeks
11332045|NCT03489343|EG005|Reported Event|Sym023 10.0 mg/kg|Sym023 10.0 mg/kg intravenous infusion once every 2 weeks
11332046|NCT03489343|EG006|Reported Event|Sym023 20.0 mg/kg|Sym023 20.0 mg/kg intravenous infusion once every 2 weeks
11332047|NCT03489369|BG000|Baseline|Dose Level 1|0.3 mg/kg dosing of Sym022 every second week (Q2W)
11332048|NCT03489369|BG001|Baseline|Dose Level 2|1.0 mg/kg dosing of Sym022 every second week (Q2W)
11332049|NCT03489369|BG002|Baseline|Dose Level 3|3 mg/kg dosing of Sym022 every second week (Q2W)
11332050|NCT03489369|BG003|Baseline|Dose Level 4|10.0 mg/kg dosing of Sym022 every second week (Q2W)
11332051|NCT03489369|BG004|Baseline|Total|Total of all reporting groups
11332052|NCT03489369|FG000|Participant Flow|Dose Level 1|0.3 mg/kg dosing of Sym022 every second week (Q2W)
11332053|NCT03489369|FG001|Participant Flow|Dose Level 2|1.0 mg/kg dosing of Sym022 every second week (Q2W)
11332054|NCT03489369|FG002|Participant Flow|Dose Level 3|3 mg/kg dosing of Sym022 every second week (Q2W)
11332055|NCT03489369|FG003|Participant Flow|Dose Level 4|10.0 mg/kg dosing of Sym022 every second week (Q2W)
11332056|NCT03489369|OG000|Outcome|Dose Level 1|0.3 mg/kg dosing of Sym022 every second week (Q2W)
11332057|NCT03489369|OG001|Outcome|Dose Level 2|1.0 mg/kg dosing of Sym022 every second week (Q2W)
11332058|NCT03489369|OG002|Outcome|Dose Level 3|3 mg/kg dosing of Sym022 every second week (Q2W)
11332059|NCT03489369|OG003|Outcome|Dose Level 4|10.0 mg/kg dosing of Sym022 every second week (Q2W)
11332060|NCT03489369|EG000|Reported Event|Dose Level 1|0.3 mg/kg dosing of Sym022 every second week (Q2W)
11332061|NCT03489369|EG001|Reported Event|Dose Level 2|1.0 mg/kg dosing of Sym022 every second week (Q2W)
11332062|NCT03489369|EG002|Reported Event|Dose Level 3|3 mg/kg dosing of Sym022 every second week (Q2W)
11332063|NCT03489369|EG003|Reported Event|Dose Level 4|10.0 mg/kg dosing of Sym022 every second week (Q2W)
11332064|NCT03489551|BG000|Baseline|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
11332065|NCT03489551|FG000|Participant Flow|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
11332066|NCT03489551|OG000|Outcome|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
11332067|NCT03489551|EG000|Reported Event|Oral Haldol in Patients Undergoing HSCT|"Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.~Haldol"
11332068|NCT03489720|BG000|Baseline|Exercise Intervention Then Usual Exercise Program|8 weeks of exercise intervention followed by 8 weeks of usual exercise program
11332069|NCT03489720|BG001|Baseline|Usual Exercise Program Then Exercise Intervention|8 weeks of usual exercise program followed by 8 weeks of exercise intervention
11332070|NCT03489720|BG002|Baseline|Total|Total of all reporting groups
11332071|NCT03489720|FG000|Participant Flow|Arm A: Exercise Intervention Then Usual Exercise Program|8 weeks of exercise intervention followed by 8 weeks of usual exercise program
11332072|NCT03489720|FG001|Participant Flow|Arm B: Usual Exercise Program Then Exercise Intervention|8 weeks of usual exercise program followed by 8 weeks of exercise intervention
11332073|NCT03489720|OG000|Outcome|Exercise Intervention|"Prescribed Exercise Program: Brief cardiovascular exercise training (>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.~The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.~Examples of possible 15-minute exercise regimens to be used include:~Walking quickly or running up and down stairs~Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc~Walking up an incline on a treadmill~Jogging or running on a treadmill or elliptical~Stationary cycling or rowing~Usual Exercise Program: Usual exercise activity for 8 weeks"
11332074|NCT03489720|OG001|Outcome|Usual Exercise Program|Usual Exercise Program: Usual exercise activity for 8 weeks
11332075|NCT03489720|OG000|Outcome|Exercise Intervention|"Prescribed Exercise Program: Brief cardiovascular exercise training (>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.~The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.~Examples of possible 15-minute exercise regimens to be used include:~Walking quickly or running up and down stairs~Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc~Walking up an incline on a treadmill~Jogging or running on a treadmill or elliptical~Stationary cycling or rowing"
11332076|NCT03489720|OG000|Outcome|Post Graduate Year 1|VUMC anesthesia post medical school graduate year 1
11332077|NCT03489720|OG001|Outcome|Post Graduate Year 2|VUMC anesthesia post medical school graduate year 2
11332078|NCT03489720|OG002|Outcome|Post Graduate Year 3|VUMC anesthesia post medical school graduate year 3
11332079|NCT03489720|EG000|Reported Event|Exercise Intervention|"Prescribed Exercise Program: Brief cardiovascular exercise training (>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.~The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.~Examples of possible 15-minute exercise regimens to be used include:~Walking quickly or running up and down stairs~Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc~Walking up an incline on a treadmill~Jogging or running on a treadmill or elliptical~Stationary cycling or rowing"
11332080|NCT03489720|EG001|Reported Event|Usual Exercise Program|Usual Exercise Program: Usual exercise activity for 8 weeks
11332081|NCT03489850|BG000|Baseline|Ibudilast|"20mg BID Days 1-2 50mg BID Days 3-14~Ibudilast: Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor."
11332082|NCT03489850|BG001|Baseline|Placebo|"Matched to active~Placebo: Placebo is matched to ibudilast active medication."
11332083|NCT03489850|BG002|Baseline|Total|Total of all reporting groups
11332084|NCT03489850|FG000|Participant Flow|Ibudilast|"20mg BID Days 1-2 50mg BID Days 3-14~Ibudilast: Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor."
11332085|NCT03489850|FG001|Participant Flow|Placebo|"Matched to active~Placebo: Placebo is matched to ibudilast active medication."
11332086|NCT03489850|OG000|Outcome|Ibudilast|"20mg BID Days 1-2 50mg BID Days 3-14~Ibudilast: Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor."
11332087|NCT03489850|OG001|Outcome|Placebo|"Matched to active~Placebo: Placebo is matched to ibudilast active medication."
11332088|NCT03489850|EG000|Reported Event|Ibudilast|"20mg BID Days 1-2 50mg BID Days 3-14~Ibudilast: Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor."
11332089|NCT03489850|EG001|Reported Event|Placebo|"Matched to active~Placebo: Placebo is matched to ibudilast active medication."
11332090|NCT03489863|BG000|Baseline|Prasugrel|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Prasugrel: Maintenance dose will be maintained for 10±3 days."
11332091|NCT03489863|BG001|Baseline|Ticagrelor|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Ticagrelor: Maintenance dose will be maintained for 10±3 days."
11332092|NCT03489863|BG002|Baseline|Total|Total of all reporting groups
11332093|NCT03489863|FG000|Participant Flow|Prasugrel|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Prasugrel: Maintenance dose will be maintained for 10±3 days."
11332094|NCT03489863|FG001|Participant Flow|Ticagrelor|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Ticagrelor: Maintenance dose will be maintained for 10±3 days."
11332095|NCT03489863|OG000|Outcome|Prasugrel|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Prasugrel: Maintenance dose will be maintained for 10±3 days."
11332096|NCT03489863|OG001|Outcome|Ticagrelor|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Ticagrelor: Maintenance dose will be maintained for 10±3 days."
11332097|NCT03489863|EG000|Reported Event|Prasugrel|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Prasugrel: Maintenance dose will be maintained for 10±3 days."
11332098|NCT03489863|EG001|Reported Event|Ticagrelor|"Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).~Ticagrelor: Maintenance dose will be maintained for 10±3 days."
11332099|NCT03489941|BG000|Baseline|Overall Participants|The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye). Demographic data were not collected by treatment or by eye.
11332100|NCT03489941|FG000|Participant Flow|EM-100|"One drop of EM-100 in either the right or left eye once on Day 1.~EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332101|NCT03489941|FG001|Participant Flow|Zaditor®|"One drop of Zaditor® in either the right or left eye once on Day 1.~Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332102|NCT03489941|FG002|Participant Flow|Vehicle|"One drop of Vehicle in either the right or left eye once on Day 1.~Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332103|NCT03489941|OG000|Outcome|EM-100|"One drop of EM-100 in either the right or left eye once on Day 1.~EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332104|NCT03489941|OG001|Outcome|Zaditor®|"One drop of Zaditor® in either the right or left eye once on Day 1.~Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332105|NCT03489941|OG002|Outcome|Vehicle|"One drop of Vehicle in either the right or left eye once on Day 1.~Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial."
11332106|NCT03489941|EG000|Reported Event|Overall Participants|The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye).
11332107|NCT03490032|BG000|Baseline|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332108|NCT03490032|BG001|Baseline|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332109|NCT03490032|BG002|Baseline|Metastatic Prostate Cancer (mPCa) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332110|NCT03490032|BG003|Baseline|Total|Total of all reporting groups
11332111|NCT03490032|FG000|Participant Flow|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332112|NCT03490032|FG001|Participant Flow|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332113|NCT03490032|FG002|Participant Flow|Metastatic Prostate Cancer (mPCa) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332114|NCT03490032|OG000|Outcome|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332115|NCT03490032|OG001|Outcome|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332116|NCT03490032|OG002|Outcome|Metastatic Prostate Cancer (mPCa) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332117|NCT03490032|OG000|Outcome|Overall|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332118|NCT03490032|EG000|Reported Event|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332119|NCT03490032|EG001|Reported Event|Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332120|NCT03490032|EG002|Reported Event|Metastatic Prostate Cancer (mPCa) (Phase II)|All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].
11332121|NCT03490110|BG000|Baseline|State Regulation Skill Training|"This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life.~State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total ~4.5 hours per week)."
11332122|NCT03490110|BG001|Baseline|Treatment-as-usual|"In this arm, participants receive clinical care as usual in VA and other clinics.~Treatment-as-usual: Participants receive clinical care as usual over a matched time period."
11332123|NCT03490110|BG002|Baseline|Total|Total of all reporting groups
11332124|NCT03490110|FG000|Participant Flow|State Regulation Skill Training|"This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life.~State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total ~4.5 hours per week)."
11332125|NCT03490110|FG001|Participant Flow|Treatment-as-usual|"In this arm, participants receive clinical care as usual in VA and other clinics.~Treatment-as-usual: Participants receive clinical care as usual over a matched time period."
11332126|NCT03490110|OG000|Outcome|State Regulation Skill Training|"This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life.~State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total ~4.5 hours per week)."
11332127|NCT03490110|OG001|Outcome|Treatment-as-usual|"In this arm, participants receive clinical care as usual in VA and other clinics.~Treatment-as-usual: Participants receive clinical care as usual over a matched time period."
11332128|NCT03490110|EG000|Reported Event|State Regulation Skill Training|"This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life.~State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total ~4.5 hours per week)."
11332129|NCT03490110|EG001|Reported Event|Treatment-as-usual|"In this arm, participants receive clinical care as usual in VA and other clinics.~Treatment-as-usual: Participants receive clinical care as usual over a matched time period."
11332130|NCT03490942|BG000|Baseline|CSGI High Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
10842380|NCT00246324|OG000|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
11332131|NCT03490942|BG001|Baseline|CSGI Low Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332132|NCT03490942|BG002|Baseline|Placebo High Infusion Rate|"Placebo given as a continuous subcutaneous infusion for 28 days~Placebo: The placebo solution is a non-active formulation containing excipients only."
11332133|NCT03490942|BG003|Baseline|Total|Total of all reporting groups
11332134|NCT03490942|FG000|Participant Flow|CSGI High Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332135|NCT03490942|FG001|Participant Flow|CSGI Low Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332136|NCT03490942|FG002|Participant Flow|Placebo High Infusion Rate|"Placebo given as a continuous subcutaneous infusion for 28 days~Placebo: The placebo solution is a non-active formulation containing excipients only."
11332137|NCT03490942|OG000|Outcome|CSGI High Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332138|NCT03490942|OG001|Outcome|CSGI Low Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332139|NCT03490942|OG002|Outcome|Placebo High Infusion Rate|"Placebo given as a continuous subcutaneous infusion for 28 days~Placebo: The placebo solution is a non-active formulation containing excipients only."
11332140|NCT03490942|EG000|Reported Event|CSGI High Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332141|NCT03490942|EG001|Reported Event|CSGI Low Infusion Rate|"Glucagon given as a continuous subcutaneous infusion for 28 days~Glucagon: CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon."
11332142|NCT03490942|EG002|Reported Event|Placebo High Infusion Rate|"Placebo given as a continuous subcutaneous infusion for 28 days~Placebo: The placebo solution is a non-active formulation containing excipients only."
11332143|NCT03490981|BG000|Baseline|Treatment as Usual (TAU) Only|"Primary care treatment as usual~TAU: Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated."
11332144|NCT03490981|BG001|Baseline|Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)|"Primary care treatment as usual and Brief CBT-CP~Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment."
11332145|NCT03490981|BG002|Baseline|Total|Total of all reporting groups
11332146|NCT03490981|FG000|Participant Flow|Treatment as Usual (TAU) Only|"Primary care treatment as usual~TAU: Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated."
11332147|NCT03490981|FG001|Participant Flow|Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)|"Primary care treatment as usual and Brief CBT-CP~Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment."
11332148|NCT03490981|OG000|Outcome|TAU Only|"Primary care treatment as usual~TAU: Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated."
11332149|NCT03490981|OG001|Outcome|TAU Plus Brief CBT-CP|"Primary care treatment as usual and Brief CBT-CP~Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment."
11332150|NCT03490981|EG000|Reported Event|Treatment as Usual (TAU) Only|"Primary care treatment as usual~TAU: Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated."
11336280|NCT03565068|FG005|Participant Flow|Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-8 mg|In addition to background AAP treatment, participant with Schizophrenia received modified regimen of MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 8 mg, as follows: Days 1-3: 4 mg, Days 4-11: 8 mg.
10842381|NCT00246324|EG000|Reported Event|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
11332151|NCT03490981|EG001|Reported Event|Treatment as Usual (TAU) Plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)|"Primary care treatment as usual and Brief CBT-CP~Brief CBT-CP: Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment."
11332152|NCT03491150|BG000|Baseline|Parent Placebo|Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332153|NCT03491150|BG001|Baseline|Parent Crenezumab|Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332154|NCT03491150|BG002|Baseline|Total|Total of all reporting groups
11332155|NCT03491150|FG000|Participant Flow|Parent Placebo|Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332156|NCT03491150|FG001|Participant Flow|Parent Crenezumab|Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332157|NCT03491150|OG000|Outcome|Parent Placebo|Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332158|NCT03491150|OG001|Outcome|Parent Crenezumab|Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332159|NCT03491150|EG000|Reported Event|Parent Placebo|Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332160|NCT03491150|EG001|Reported Event|Parent Crenezumab|Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
11332161|NCT03491228|BG000|Baseline|ANAEMETRO Intravenous Infusion (Metronidazole)|Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
11332162|NCT03491228|FG000|Participant Flow|ANAEMETRO Intravenous Infusion (Metronidazole)|Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
11332163|NCT03491228|OG000|Outcome|ANAEMETRO Intravenous Infusion (Metronidazole)|Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
11332164|NCT03491228|EG000|Reported Event|ANAEMETRO Intravenous Infusion (Metronidazole)|Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion.
11332165|NCT03491553|BG000|Baseline|Selgantolimod 3 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332166|NCT03491553|BG001|Baseline|Selgantolimod 3 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332167|NCT03491553|BG002|Baseline|Selgantolimod 1.5 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332168|NCT03491553|BG003|Baseline|Selgantolimod 1.5 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332169|NCT03491553|BG004|Baseline|Placebo: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332170|NCT03491553|BG005|Baseline|Placebo: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332171|NCT03491553|BG006|Baseline|Total|Total of all reporting groups
11332172|NCT03491553|FG000|Participant Flow|Selgantolimod 3 mg: HBeAg-positive CHB Participants|Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remained on their current oral antiviral (OAV) and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants could continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.
11332173|NCT03491553|FG001|Participant Flow|Selgantolimod 3 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332174|NCT03491553|FG002|Participant Flow|Selgantolimod 1.5 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332175|NCT03491553|FG003|Participant Flow|Selgantolimod 1.5 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332176|NCT03491553|FG004|Participant Flow|Placebo: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332177|NCT03491553|FG005|Participant Flow|Placebo: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332178|NCT03491553|OG000|Outcome|Selgantolimod 3 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332179|NCT03491553|OG001|Outcome|Selgantolimod 3 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332180|NCT03491553|OG002|Outcome|Selgantolimod 1.5 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332181|NCT03491553|OG003|Outcome|Selgantolimod 1.5 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332182|NCT03491553|OG004|Outcome|Placebo: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332183|NCT03491553|OG005|Outcome|Placebo: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332184|NCT03491553|OG001|Outcome|Selgantolimod 1.5 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332185|NCT03491553|OG002|Outcome|Placebo: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
11332186|NCT03491553|EG000|Reported Event|Selgantolimod 3 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332187|NCT03491553|EG001|Reported Event|Selgantolimod 3 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332188|NCT03491553|EG002|Reported Event|Selgantolimod 1.5 mg: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332189|NCT03491553|EG003|Reported Event|Selgantolimod 1.5 mg: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11336281|NCT03565068|FG006|Participant Flow|Panel C (Schizophrenia Participants): Placebo Add-on Therapy|In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18.
11332190|NCT03491553|EG004|Reported Event|Placebo: HBeAg-positive CHB Participants|Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332191|NCT03491553|EG005|Reported Event|Placebo: HBeAg-negative CHB Participants|Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
11332192|NCT03491800|BG000|Baseline|Accompanied Patients|The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
11332193|NCT03491800|BG001|Baseline|Companions|Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
11332194|NCT03491800|BG002|Baseline|Unaccompanied Patients|The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
11332195|NCT03491800|BG003|Baseline|Total|Total of all reporting groups
11332196|NCT03491800|FG000|Participant Flow|Accompanied Patients|The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
11332197|NCT03491800|FG001|Participant Flow|Companions|Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
11332198|NCT03491800|FG002|Participant Flow|Unaccompanied Patients|The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
11332199|NCT03491800|OG000|Outcome|Patient and Companions|All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
11332200|NCT03491800|OG000|Outcome|Accompanied Patients|The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
11332201|NCT03491800|OG001|Outcome|Companions|Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
11332202|NCT03491800|OG002|Outcome|Unaccompanied Patients|The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
11332203|NCT03491800|EG000|Reported Event|Accompanied Patients|The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
11332204|NCT03491800|EG001|Reported Event|Companions|Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
11332205|NCT03491800|EG002|Reported Event|Unaccompanied Patients|The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
11332206|NCT03491891|BG000|Baseline|Derivation Cohort|Patients enrolled in Jilin University First Hospital, no interventions will be administrated
11332207|NCT03491891|BG001|Baseline|Validation Cohort|Patients enrolled in First Affiliated Hosptal of Shantou University, no interventions will be administrated
11332208|NCT03491891|BG002|Baseline|Total|Total of all reporting groups
11332209|NCT03491891|FG000|Participant Flow|Derivation Cohort|Patients enrolled in the study in Jilin University First Hospital, no interventions will be administrated
10842382|NCT00246337|BG000|Baseline|Placebo|"Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
11332210|NCT03491891|FG001|Participant Flow|Validation Cohort|Patiens enrolled in the study in First affiliated Hospital of Shantou University, no interventions will be administrated
11332211|NCT03491891|OG000|Outcome|Derivation Cohort|no interventions will be administrated
11332212|NCT03491891|OG001|Outcome|Validation Cohort|no interventions will be administrated
11332213|NCT03491891|EG000|Reported Event|Derivation Cohort|no interventions will be administrated
11332214|NCT03491891|EG001|Reported Event|Validation Cohort|no interventions will be administrated
11332215|NCT03491917|BG000|Baseline|DBT Plus S-View and FFDM Alone|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332216|NCT03491917|FG000|Participant Flow|DBT Plus S-View|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332217|NCT03491917|FG001|Participant Flow|FFDM Alone|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332218|NCT03491917|OG000|Outcome|DBT Plus S-View|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332219|NCT03491917|OG001|Outcome|FFDM Alone|Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
11332220|NCT03491917|EG000|Reported Event|DBT Plus S-View|"Breast images utilizing DBT plus S-View~DBT plus S-View: DBT plus S-View images"
11332221|NCT03491917|EG001|Reported Event|FFDM Alone|"Breast images using FFDM alone only~FFDM alone: FFDM alone images"
11332222|NCT03492281|BG000|Baseline|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332223|NCT03492281|BG001|Baseline|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332224|NCT03492281|BG002|Baseline|Tolterodine ER 4 mg|Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332225|NCT03492281|BG003|Baseline|Total|Total of all reporting groups
11332226|NCT03492281|FG000|Participant Flow|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332227|NCT03492281|FG001|Participant Flow|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332228|NCT03492281|FG002|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332229|NCT03492281|OG000|Outcome|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332230|NCT03492281|OG001|Outcome|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332231|NCT03492281|OG002|Outcome|Tolterodine ER 4 mg|Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332232|NCT03492281|OG000|Outcome|Placebo: OAB Wet|Participants who met the definition of OAB Wet at study entry (based on the PVD) received matching placebo, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332233|NCT03492281|OG001|Outcome|Vibegron 75 mg: OAB Wet|Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332234|NCT03492281|OG002|Outcome|Tolterodine ER 4 mg: OAB Wet|Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332235|NCT03492281|EG000|Reported Event|Placebo|Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332236|NCT03492281|EG001|Reported Event|Vibegron 75 mg|Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332237|NCT03492281|EG002|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11332238|NCT03492398|BG000|Baseline|Cohort A Placebo|single dose of placebo 8 subjects
11332239|NCT03492398|BG001|Baseline|Cohort A HY209 0.05% Gel|single dose of HY209 0.05% gel 6 subjects
11332240|NCT03492398|BG002|Baseline|Cohort A HY209 0.1% Gel|single dose of HY209 0.1% gel 6 subjects
11332241|NCT03492398|BG003|Baseline|Cohort A HY209 0.3% Gel|single dose of HY209 0.3% gel 6 subjects
11332242|NCT03492398|BG004|Baseline|Cohort A HY209 0.5% Gel|single dose of HY209 0.5% gel 6 subjects
11332243|NCT03492398|BG005|Baseline|Cohort B Placebo|multiple dose of placebo 6 subjects
11332244|NCT03492398|BG006|Baseline|Cohort B HY209 0.1% Gel|multiple dose of HY209 0.1% gel 6 subjects
11332245|NCT03492398|BG007|Baseline|Cohort B HY209 0.3% Gel|multiple dose of HY209 0.3% gel 6 subjects
11332246|NCT03492398|BG008|Baseline|Cohort B HY209 0.5% Gel|multiple dose of HY209 0.5% gel 6 subjects
11332247|NCT03492398|BG009|Baseline|Total|Total of all reporting groups
11332248|NCT03492398|FG000|Participant Flow|Cohort A HY209 Placebo|"single dose of placebo~total 8 subjects participated."
11332249|NCT03492398|FG001|Participant Flow|Cohort A HY209 0.05% Gel|"single dose of HY209 0.05% gel~total 6 subjects participated."
11332250|NCT03492398|FG002|Participant Flow|Cohort A HY209 0.1% Gel|"single dose of HY209 0.1% gel~total 6 subjects participated."
11332251|NCT03492398|FG003|Participant Flow|Cohort A HY209 0.3% Gel|"single dose of HY209 0.3% gel~total 6 subjects participated."
11332252|NCT03492398|FG004|Participant Flow|Cohort A HY209 0.5% Gel|"single dose of HY209 0.5% gel~total 6 subjects participated."
11332253|NCT03492398|FG005|Participant Flow|Cohort B Placebo|"multiple dose of placebo~total 6 subjects participated."
11332254|NCT03492398|FG006|Participant Flow|Cohort B HY209 0.1% Gel|"multiple dose of HY209 0.1% gel~total 6 subjects participated."
11332255|NCT03492398|FG007|Participant Flow|Cohort B HY209 0.3% Gel|"multiple dose of HY209 0.3% gel~total 6 subjects participated."
11332256|NCT03492398|FG008|Participant Flow|Cohort B HY209 0.5% Gel|"multiple dose of HY209 0.5% gel~total 6 subjects participated."
11332257|NCT03492398|OG000|Outcome|Cohort A Placebo|"single dose of placebo~total 8 subjects assigned."
11332258|NCT03492398|OG001|Outcome|Cohort A HY209 0.05% Gel|"single dose of HY209 0.05% gel~total 6 subjects assigned."
11332259|NCT03492398|OG002|Outcome|Cohort A HY209 0.1% Gel|"single dose of HY209 0.1% gel~total 6 subjects assigned."
11332260|NCT03492398|OG003|Outcome|Cohort A HY209 0.3% Gel|"single dose of HY209 0.3% gel~total 6 subjects assigned."
11332261|NCT03492398|OG004|Outcome|Cohort A HY209 0.5% Gel|"single dose of HY209 0.5% gel~total 6 subjects assinged."
11332262|NCT03492398|OG005|Outcome|Cohort B Placebo|"multiple dose of placebo~total 6 subjects assigned."
11332263|NCT03492398|OG006|Outcome|Cohort B HY209 0.1% Gel|"multiple dose of HY209 0.1% gel~total 6 subjects assigned."
11332264|NCT03492398|OG007|Outcome|Cohort B HY209 0.3% Gel|"multiple dose of HY209 0.3% gel~total 6 subjects assigned."
11332265|NCT03492398|OG008|Outcome|Cohort B HY209 0.5% Gel|"multiple dose of HY209 0.5% gel~total 6 subjects assigned."
11332266|NCT03492398|EG000|Reported Event|Cohort A HY209 Placebo|"single dose of placebo~total 8 subjects assigned."
11332267|NCT03492398|EG001|Reported Event|Cohort A HY209 0.05% Gel|"single dose of HY209 0.05% gel~total 6 subjects assigned."
11332268|NCT03492398|EG002|Reported Event|Cohort A HY209 0.1% Gel|"single dose of HY209 0.1% gel~total 6 subjects assigned."
11332269|NCT03492398|EG003|Reported Event|Cohort A HY209 0.3% Gel|"single dose of HY209 0.3% gel~total 6 subjects assigned."
11332270|NCT03492398|EG004|Reported Event|Cohort A HY209 0.5% Gel|"single dose of HY209 0.5% gel~total 6 subjects assigned."
11332271|NCT03492398|EG005|Reported Event|Cohort B Placebo|"multiple dose of placebo~total 6 subjects assigned."
11332272|NCT03492398|EG006|Reported Event|Cohort B HY209 0.1% Gel|"multiple dose of HY209 0.1% gel~total 6 subjects assigned."
11332273|NCT03492398|EG007|Reported Event|Cohort B HY209 0.3% Gel|"multiple dose of HY209 0.3%~total 6 subjects assigned."
11332274|NCT03492398|EG008|Reported Event|Cohort B HY209 0.5% Gel|"multiple dose of HY209 0.5%~total 6 subjects assigned."
11332275|NCT03492554|BG000|Baseline|Atrial Fibrillation (AF)|"Patient with a known history of AF who is in AF at the time of study screening.~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332276|NCT03492554|BG001|Baseline|Normal Sinus Rhythm (SR)|"Patient with no known diagnosis of AF or other arrhythmia~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332277|NCT03492554|BG002|Baseline|Total|Total of all reporting groups
11332278|NCT03492554|FG000|Participant Flow|Atrial Fibrillation (AF)|"Patient with a known history of AF who is in AF at the time of study screening.~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332279|NCT03492554|FG001|Participant Flow|Normal Sinus Rhythm (SR)|"Patient with no known diagnosis of AF or other arrhythmia~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332280|NCT03492554|OG000|Outcome|Normal Sinus Rhythm (SR)|"Patient with no known diagnosis of AF or other arrhythmia~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332281|NCT03492554|OG000|Outcome|Atrial Fibrillation (AF)|"Patient with a known history of AF who is in AF at the time of study screening.~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332282|NCT03492554|OG001|Outcome|Normal Sinus Rhythm (SR)|"Patient with no known diagnosis of AF or other arrhythmia~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332283|NCT03492554|EG000|Reported Event|Atrial Fibrillation (AF)|"Patient with a known history of AF who is in AF at the time of study screening.~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332284|NCT03492554|EG001|Reported Event|Normal Sinus Rhythm (SR)|"Patient with no known diagnosis of AF or other arrhythmia~1-Lead ECG: All participants will record three single-lead ECGs~12-Lead ECG: All participants will simultaneously record three 12-lead ECGs"
11332285|NCT03493386|BG000|Baseline|Total Participants Part 1|Participants received daprodustat 2mg*2 tablets and daprodustat 4mg*1 tablets (fasted state) in either of the two treatment periods separated by a washout of at least 5 days between the two treatment periods.
11332286|NCT03493386|BG001|Baseline|Total Participants Part 2|Participants received daprodustat 4mg*1 tablet (fed state) and daprodustat 4mg*1 tablet (fasted state) in either of the two treatment periods separated by a washout of at least 5 days between the two treatment periods.
11332287|NCT03493386|BG002|Baseline|Total|Total of all reporting groups
11332288|NCT03493386|FG000|Participant Flow|Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1|Participants received a single dose Daprodustat 2 milligram (mg) two tablets followed by Daprodustat 4 mg single tablet, administered orally on Day 1.There was a washout period of at least 5 days between the 2 intervention periods.
11332289|NCT03493386|FG001|Participant Flow|Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2|Participants received a single dose Daprodustat 4 mg one tablet followed by Daprodustat 2 mg two tablets, administered orally on Day 1. There was a washout period of at least 5 days between the 2 intervention periods.
11332290|NCT03493386|FG002|Participant Flow|Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast)|Participants received a single dose Daprodustat 4 mg one tablet in fed state followed by Daprodustat 4 mg one tablet as single dose in fasted state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
11332291|NCT03493386|FG003|Participant Flow|Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed)|Participants received a single dose Daprodustat 4 mg one tablet in fasted state followed by Daprodustat 4 mg one tablet as single dose in fed state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
11332292|NCT03493386|OG000|Outcome|Part 1: Daprodustat 2mg*2|Participants received a single dose of daprodustat 2mg*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
11332293|NCT03493386|OG001|Outcome|Part 1: Daprodustat 4mg*1|Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
11332294|NCT03493386|OG000|Outcome|Daprodustat 4mg (Fed)|Participants received a single dose of daprodustat 4mg one tablet, administered orally in fed state on Day 1 in intervention period 1
11332295|NCT03493386|OG001|Outcome|Daprodustat 4mg(Fasted)|Participants received single dose of daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in intervention Period 2
11332296|NCT03493386|OG000|Outcome|Daprodustat 4mg Fed|Participants received a single dose of daprodustat 4mg one tablet, administered orally in fed state on Day 1 in intervention period 1
11332297|NCT03493386|OG001|Outcome|Daprodustat 4mg Fasted|Participants received single dose of daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in intervention Period 2
11332298|NCT03493386|OG001|Outcome|Part 2: Daprodustat 4mg Fasted|Participants received single dose of daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in intervention Period 2
11332299|NCT03493386|OG000|Outcome|Part 2: Daprodustat 4mg Fed|Participants received a single dose of daprodustat 4mg one tablet, administered orally in fed state on Day 1 in intervention period 1
11332300|NCT03493386|OG000|Outcome|Part 2: Daprodustat 4mg Fed|Participants received a single dose of daprodustat 2mg*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
11332301|NCT03493386|OG000|Outcome|Part 2: Daprodustat 4mg (Fed)|Participants received a single dose of daprodustat 4mg one tablet, administered orally in fed state on Day 1 in intervention period 1, the washout between the 2 intervention periods was set to be ≥ 5 days
11332302|NCT03493386|OG001|Outcome|Part 2: Daprodustat 4mg (Fasted)|Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in intervention Period 2
11332303|NCT03493386|EG000|Reported Event|Daprodustat 2mg*2 Followed by Daprodustat 4mg*1|Participants received a single dose Daprodustat 2 milligram (mg) two tablets followed by Daprodustat 4 mg single tablet, administered orally on Day 1.
11332304|NCT03493386|EG001|Reported Event|Daprodustat 4mg*1 Tablet Followed by Daprodustat 2mg*2tablets|Participants received a single dose Daprodustat 4 mg one tablet followed by Daprodustat 2 mg two tablets, administered orally on Day 1.
11332305|NCT03493386|EG002|Reported Event|Daprodustat 4mg*1 (Fed) Followed by Daprodustat 4mg*1 (Fasted)|Participants received a single dose Daprodustat 4 mg one tablet in fed state followed by Daprodustat 4 mg one tablet as single dose in fasted state, administered orally on Day 1.
11332306|NCT03493386|EG003|Reported Event|Daprodustat 4mg*1 (Fasted) Followed by Daprodustat 4mg*1(Fed)|Participants received a single dose Daprodustat 4 mg one tablet in fasted state followed by Daprodustat 4 mg one tablet as single dose in fed state, administered orally on Day 1.
11332307|NCT03493542|BG000|Baseline|Chinese Girls Aged 9 to 19 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332308|NCT03493542|BG001|Baseline|Chinese Young Women Aged 20 to 26 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332309|NCT03493542|BG002|Baseline|Total|Total of all reporting groups
11332310|NCT03493542|FG000|Participant Flow|Chinese Girls Aged 9 to 19 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332311|NCT03493542|FG001|Participant Flow|Chinese Young Women Aged 20 to 26 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332312|NCT03493542|OG000|Outcome|Chinese Girls Aged 9 to 19 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332313|NCT03493542|OG001|Outcome|Chinese Young Women Aged 20 to 26 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332314|NCT03493542|EG000|Reported Event|Chinese Girls Aged 9 to 19 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332315|NCT03493542|EG001|Reported Event|Chinese Young Women Aged 20 to 26 Years|Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
11332316|NCT03493607|BG000|Baseline|AMO-01|Subjects received a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
11332317|NCT03493607|FG000|Participant Flow|AMO-01|Subjects received a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
11332318|NCT03493607|OG000|Outcome|AMO-01|Subjects received a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
11332319|NCT03493607|EG000|Reported Event|AMO-01|Subjects received a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
11332320|NCT03493698|BG000|Baseline|Sequential Single, Multi-day & Combo Midazolam and Inarigivir|"A: All subjects will receive a single oral dose of 2 mg Midazolam on Day 1~B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~C: All subjects receive oral dose of 400 mg Inarigivir once daily from Day 6 to Day 18~D: All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19"
11332321|NCT03493698|FG000|Participant Flow|Sequential Single, Multi-day & Combo Midazolam and Inarigivir|"A: All subjects will receive a single oral dose of 2 mg Midazolam on Day 1~B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~C: All subjects receive oral dose of 400 mg Inarigivir once daily from Day 6 to Day 18~D: All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19"
11332322|NCT03493698|OG000|Outcome|Treatment A: Midazolam|"All subjects will receive a single oral dose of 2 mg Midazolam on Day 1~Midazolam: Midazolam"
11332323|NCT03493698|OG001|Outcome|Treatment B and C: Inarigivir|"B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~C: All subjects receive oral dose of 400 mg Inarigivir once daily from Day 6 to Day 18~Inarigivir: Inarigivir"
11332324|NCT03493698|OG002|Outcome|Treatment D: Inarigivir With Midazolam|"All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19~Midazolam: Midazolam~Inarigivir: Inarigivir"
11332325|NCT03493698|OG001|Outcome|Treatment B: Inarigivir|"B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~Inarigivir: Inarigivir"
11332326|NCT03493698|OG002|Outcome|Treatment C: Inarigivir|"C: All subjects receive oral dose of 400 mg Inarigivir once daily from Day 6 to Day 18~Inarigivir: Inarigivir"
11332327|NCT03493698|OG003|Outcome|Treatment D: Inarigivir With Midazolam|"All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19~Midazolam: Midazolam~Inarigivir: Inarigivir"
11332328|NCT03493698|OG000|Outcome|Treatment B: Inarigivir|"B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~Inarigivir: Inarigivir"
11332329|NCT03493698|OG001|Outcome|Treatment D: Inarigivir With Midazolam|"All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19~Midazolam: Midazolam~Inarigivir: Inarigivir"
11332330|NCT03493698|EG000|Reported Event|Treatment A: Midazolam|"All subjects will receive a single oral dose of 2 mg Midazolam on Day 1~Midazolam: Midazolam"
11332331|NCT03493698|EG001|Reported Event|Treatment B: Inarigivir|"B: All subjects will receive a single oral dose of 400 mg Inarigivir on Day 3~Inarigivir: Inarigivir"
11332332|NCT03493698|EG002|Reported Event|Treatment C: Inarigivir|"C: All subjects receive oral dose of 400 mg Inarigivir once daily from Day 6 to Day 18~Inarigivir: Inarigivir"
11332333|NCT03493698|EG003|Reported Event|Treatment D: Inarigivir With Midazolam|"All subjects will receive a single oral dose of 400 mg Inarigivir coadministered with a single oral dose of 2 mg Midazolam on Day 19~Midazolam: Midazolam~Inarigivir: Inarigivir"
11332334|NCT03493815|BG000|Baseline|Transabdominal Ultrasound Guided IUD Insertion|Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332335|NCT03493815|BG001|Baseline|Traditional Blind IUD Insertion|Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332336|NCT03493815|BG002|Baseline|Total|Total of all reporting groups
11332337|NCT03493815|FG000|Participant Flow|Transabdominal Ultrasound Guided IUD Insertion|Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332338|NCT03493815|FG001|Participant Flow|Traditional Blind IUD Insertion|Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332339|NCT03493815|OG000|Outcome|Transabdominal Ultrasound Guided IUD Insertion|Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332340|NCT03493815|OG001|Outcome|Traditional Blind IUD Insertion|Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332341|NCT03493815|EG000|Reported Event|Transabdominal Ultrasound Guided IUD Insertion|Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332342|NCT03493815|EG001|Reported Event|Traditional Blind IUD Insertion|Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
11332343|NCT03493828|BG000|Baseline|TAP Using Bupivacaine 0.5%|TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332344|NCT03493828|BG001|Baseline|TAP Using Bupivacaine 0.25%|TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332345|NCT03493828|BG002|Baseline|Placebo|TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332346|NCT03493828|BG003|Baseline|Total|Total of all reporting groups
11332347|NCT03493828|FG000|Participant Flow|TAP Using Bupivacaine 0.5%|TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332348|NCT03493828|FG001|Participant Flow|TAP Using Bupivacaine 0.25%|TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332349|NCT03493828|FG002|Participant Flow|Placebo|TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332350|NCT03493828|OG000|Outcome|TAP Using Bupivacaine 0.5%|TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332351|NCT03493828|OG001|Outcome|TAP Using Bupivacaine 0.25%|TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332352|NCT03493828|OG002|Outcome|Placebo|TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332353|NCT03493828|EG000|Reported Event|TAP Using Bupivacaine 0.5%|TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332354|NCT03493828|EG001|Reported Event|TAP Using Bupivacaine 0.25%|TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332355|NCT03493828|EG002|Reported Event|Placebo|TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
11332356|NCT03494725|BG000|Baseline|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37 (Lpc-37)~Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11332357|NCT03494725|BG001|Baseline|Placebo|"Placebo: capsule manufactured to mimic Lpc-37 capsule~Ingredients: microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11332358|NCT03494725|BG002|Baseline|Total|Total of all reporting groups
11332359|NCT03494725|FG000|Participant Flow|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37~Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the Investigational Product (IP) every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11332360|NCT03494725|FG001|Participant Flow|Placebo|"Placebo: capsule manufactured to mimic Lpc-37 capsule~Ingredients: microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the Investigational Product (IP) every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11332361|NCT03494725|OG000|Outcome|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37 Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified for both groups by gender and underlying chronic stress, as assessed using the Trier Inventory for Chronic Stress (TICS)."
11332362|NCT03494725|OG001|Outcome|Placebo|"Placebo: capsule manufactured to mimic Lpc-37 capsule~Ingredients: microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified by gender and stress level to both groups."
11332363|NCT03494725|OG000|Outcome|Lpc-37|"Verum: Lacticaseibacillus paracasei Lpc-37~Ingredients: Lacticaseibacillus paracasei Lpc-37 at 1,75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide~Participants took one capsule of the IP every morning for 5 weeks, 30 minutes before breakfast or their first meal of the day, with a glass of plain (non-sparkling) water.~Participants were stratified by gender and stress level to both groups."
11332364|NCT03494725|OG000|Outcome|Lpc-37|"Lactobacillus paracasei Lpc-37~1x 1 capsule in the morning for 5 weeks~Lpc-37: Lactobacillus paracasei Lpc-37 at 1.75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide"
11332365|NCT03494725|OG001|Outcome|Placebo|"Placebo capsule manufactured to mimic Lpc-37 capsule~1x 1 capsule in the morning for 5 weeks~Placebo: microcrystalline cellulose, magnesium stearate, silicon dioxide"
11335713|NCT03554954|OG002|Outcome|Overall Data|Overall Subject Data
10851620|NCT00307125|BG002|Baseline|Total|Total of all reporting groups
10851621|NCT00307125|FG000|Participant Flow|Screening Phase|Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
10851622|NCT00307125|FG001|Participant Flow|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851623|NCT00307125|FG002|Participant Flow|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851624|NCT00307125|OG000|Outcome|Screening Phase|Participants who were analyzed during the screening phase/stage of the study
10851625|NCT00307125|OG000|Outcome|Screening Phase|Participants who were analyzed during the screening phase of the study
10851626|NCT00307125|OG000|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851627|NCT00307125|OG001|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851628|NCT00307125|OG000|Outcome|Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851629|NCT00307125|OG001|Outcome|Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression is site-specific."
10851630|NCT00307125|EG000|Reported Event|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851631|NCT00307125|EG001|Reported Event|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851632|NCT00307151|BG000|Baseline|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
10851633|NCT00307151|BG001|Baseline|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
10851634|NCT00307151|BG002|Baseline|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
10851635|NCT00307151|BG003|Baseline|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
10851636|NCT00307151|BG004|Baseline|Total|Total of all reporting groups
10851637|NCT00307151|FG000|Participant Flow|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
10851638|NCT00307151|FG001|Participant Flow|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
10851639|NCT00307151|FG002|Participant Flow|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
10851640|NCT00307151|FG003|Participant Flow|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
10851641|NCT00307151|OG000|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
10851642|NCT00307151|OG001|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
10851643|NCT00307151|OG002|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
10851644|NCT00307151|OG003|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
10851645|NCT00307151|EG000|Reported Event|Coh I: NVP|Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
10851646|NCT00307151|EG001|Reported Event|Coh I: LPV/r|Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
10851647|NCT00307151|EG002|Reported Event|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.
10851648|NCT00307151|EG003|Reported Event|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
10851649|NCT00307164|BG000|Baseline|NucleomaxX|Participants received NucleomaxX for uridine through week 48
10851650|NCT00307164|BG001|Baseline|Placebo|Participants received NucleomaxX placebo through week 48
10851651|NCT00307164|BG002|Baseline|Total|Total of all reporting groups
10851652|NCT00307164|FG000|Participant Flow|NucleomaxX|Participants received NucleomaxX for uridine through week 48
10851653|NCT00307164|FG001|Participant Flow|Placebo|Participants received NucleomaxX placebo through week 48
10851654|NCT00307164|OG000|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
10851655|NCT00307164|OG001|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
10851656|NCT00307164|EG000|Reported Event|NucleomaxX|Participants received NucleomaxX for uridine through week 48
10851657|NCT00307164|EG001|Reported Event|Placebo|Participants received NucleomaxX placebo through week 48
10851658|NCT00307294|BG000|Baseline|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
11333918|NCT03521141|OG000|Outcome|Guideline-Based Care (GBC)|"GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333919|NCT03521141|OG001|Outcome|Nicotine Metabolite Ratio (PC-NMR)|"Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333920|NCT03521141|OG002|Outcome|Respiragene (PC-Respiragene)|"Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333921|NCT03521141|EG000|Reported Event|Guideline-Based Care (GBC)|"GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333922|NCT03521141|EG001|Reported Event|Nicotine Metabolite Ratio (PC-NMR)|"Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333923|NCT03521141|EG002|Reported Event|Respiragene (PC-Respiragene)|"Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.~Nicotine patch: FDA-approved smoking cessation pharmacotherapy~Varenicline: FDA-approved smoking cessation pharmacotherapy~Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.~NCI Clearing the Air: A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle."
11333924|NCT03521193|BG000|Baseline|PFO Patients Enrolled|"We enrolled consecutive patients who met the inclusion criteria, symptomatic for migraine alone and Migraine with aura (MHA) patients.~The leading indication to PFO closure was a previous TIA or stroke in 37 patients while an off-label indication was offered to 25 patients. These pts underwent PFO closure with the Occlutech Figulla device and treated with dual antiplatelet therapy (Aspirin 100 mg/day + Clopidogrel 75 mg/day), followed by aspirin 100 mg/day alone."
11333925|NCT03521193|BG001|Baseline|Healthy Subjects|Healthy subjects on aspirin treatment by at least 15 days were the comparative group for platelet aggregation markers and activation markers, platelet procoagulant, circulating serotonin and cell-associated procoagulant potential
11333926|NCT03521193|BG002|Baseline|Total|Total of all reporting groups
11333927|NCT03521193|FG000|Participant Flow|PFO and Migraine Pts|93 consecutive patients addressed to PFO closure and suffering from migraine with aura were prospectively screened. 78 patients were enrolled in the study (T0)
11333928|NCT03521193|FG001|Participant Flow|Healthy Subjects on Aspirin|12 healthy subjects on ASA treatment were the control group for phase 2 study
11333929|NCT03521193|OG000|Outcome|Migraine Assessment After PFO Closure|Migraine symptoms evaluation after PFO closure
11333930|NCT03521193|OG000|Outcome|PFO Patients Enrolled|"We enrolled consecutive patients who met the inclusion criteria, symptomatic for migraine alone and Migraine with aura (MHA) patients. Eight patients refused to continue the study and eight were non-compliant to antiplatelet therapy during the follow-up. .~The leading indication to PFO closure was a previous TIA or stroke in 37 patients while an off-label indication was offered to 25 patients. These pts underwent PFO closure with the Occlutech Figulla device and treated with dual antiplatelet therapy (Aspirin 100 mg/day + Clopidogrel 75 mg/day), followed by aspirin 100 mg/day alone."
11333931|NCT03521193|OG000|Outcome|PFO Patients Enrolled|We enrolled 62 consecutive PFO patients suffering from migraine, addressed to PFO closure. The leading indication to PFO closure was a previous TIA or stroke in 37 patients while an off-label indication was offered to 25 patients.
11333932|NCT03521193|EG000|Reported Event|Migraine Evaluation in PFO Patients|Patients symptomatic for migraine with/o aura and addressed to patent foramen ovale closure (Occlutech Figulla Flex II PFO occluder device) for a previous ischemic event, will receive dual antiplatelet therapy (DAPT) for 2 months after procedure and aspirin alone subsequently. Clinical evaluation performed during in-hospital stay, at 6- and 12-months follow-up
11333933|NCT03521193|EG001|Reported Event|Healthy Subjects|control Healthy subjects group
11333934|NCT03521479|BG000|Baseline|Group A|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333935|NCT03521479|BG001|Baseline|Group B|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333936|NCT03521479|BG002|Baseline|Group C|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333937|NCT03521479|BG003|Baseline|Group D|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333938|NCT03521479|BG004|Baseline|Total|Total of all reporting groups
11333939|NCT03521479|FG000|Participant Flow|Group A|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333940|NCT03521479|FG001|Participant Flow|Group B|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333941|NCT03521479|FG002|Participant Flow|Group C|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333942|NCT03521479|FG003|Participant Flow|Group D|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333943|NCT03521479|OG000|Outcome|Group A|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333944|NCT03521479|OG001|Outcome|Group B|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333945|NCT03521479|OG002|Outcome|Group C|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333946|NCT03521479|OG003|Outcome|Group D|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333947|NCT03521479|EG000|Reported Event|Group A|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
10846529|NCT00277394|FG000|Participant Flow|Innohep®|innohep® 175 anti-Xa IU/kg once daily
11333948|NCT03521479|EG001|Reported Event|Group B|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333949|NCT03521479|EG002|Reported Event|Group C|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333950|NCT03521479|EG003|Reported Event|Group D|"Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.~Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months)."
11333951|NCT03521505|BG000|Baseline|Dexmedetomidine Arm|"Dexmedetomidine will be administrated for sedation of EBUS-TBNA~Dexmedetomidine arm: Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration"
11335388|NCT03549338|EG001|Reported Event|Arm B (Futuximab)|Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
11335389|NCT03549429|BG000|Baseline|TegadermTM on R Eye, EyeGard® on L Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11335714|NCT03554954|EG000|Reported Event|Association Between Food/Nutrient Intake and Sleep Quality|This is a cross-sectional study and it does not have an arm/group
11333952|NCT03521505|BG001|Baseline|Propofol Arm|"Propofol will be administrated for sedation of EBUS-TBNA~Propofol arm: 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration."
11333953|NCT03521505|BG002|Baseline|Total|Total of all reporting groups
11333954|NCT03521505|FG000|Participant Flow|Dexmedetomidine Arm|"Dexmedetomidine will be administrated for sedation of EBUS-TBNA~Dexmedetomidine arm: Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration"
11333955|NCT03521505|FG001|Participant Flow|Propofol Arm|"Propofol will be administrated for sedation of EBUS-TBNA~Propofol arm: 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration."
11333956|NCT03521505|OG000|Outcome|Dexmedetomidine Arm|"Dexmedetomidine will be administrated for sedation of EBUS-TBNA~Dexmedetomidine arm: Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration"
11333957|NCT03521505|OG001|Outcome|Propofol Arm|"Propofol will be administrated for sedation of EBUS-TBNA~Propofol arm: 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration."
11333958|NCT03521505|EG000|Reported Event|Dexmedetomidine Arm|"Dexmedetomidine will be administrated for sedation of EBUS-TBNA~Dexmedetomidine arm: Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration"
11333959|NCT03521505|EG001|Reported Event|Propofol Arm|"Propofol will be administrated for sedation of EBUS-TBNA~Propofol arm: 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration."
11333960|NCT03521635|BG000|Baseline|Pramipexole Sustained Release|Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
11333961|NCT03521635|BG001|Baseline|Pramipexole Immediate Release|"Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.~The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects."
11333962|NCT03521635|BG002|Baseline|Total|Total of all reporting groups
11336409|NCT03566238|BG003|Baseline|Total|Total of all reporting groups
11333963|NCT03521635|FG000|Participant Flow|Pramipexole Sustained Release|Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
11333964|NCT03521635|FG001|Participant Flow|Pramipexole Immediate Release|"Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.~The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects."
11333965|NCT03521635|OG000|Outcome|Pramipexole Sustained Release|Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
11333966|NCT03521635|OG001|Outcome|Pramipexole Immediate Release|"Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.~The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects."
11333967|NCT03521635|EG000|Reported Event|Pramipexole Sustained Release|Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
11333968|NCT03521635|EG001|Reported Event|Pramipexole Immediate Release|"Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.~The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects."
11333969|NCT03521791|BG000|Baseline|PRO-155|"Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days~PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014~Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333970|NCT03521791|BG001|Baseline|Placebo|"Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac~Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333971|NCT03521791|BG002|Baseline|Total|Total of all reporting groups
11333972|NCT03521791|FG000|Participant Flow|PRO-155|"Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days~PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014~Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333973|NCT03521791|FG001|Participant Flow|Placebo|"Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac~Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333974|NCT03521791|OG000|Outcome|PRO-155|"Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days~PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014~Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333975|NCT03521791|OG001|Outcome|Placebo|"Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac~Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333976|NCT03521791|EG000|Reported Event|PRO-155|"Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days~PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014~Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11333977|NCT03521791|EG001|Reported Event|Placebo|"Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac~Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
11336404|NCT03565887|EG000|Reported Event|RVL-1201 Ophthalmic Solution, 0.1%|One drop each eye QD in the morning (n=109)
11333978|NCT03521817|BG000|Baseline|Alcohol|"Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the ~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila).~Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol."
11333979|NCT03521817|BG001|Baseline|No Alcohol|"No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat).~No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol"
11333980|NCT03521817|BG002|Baseline|Total|Total of all reporting groups
11333981|NCT03521817|FG000|Participant Flow|Alcohol|"Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the ~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila).~Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol."
11333982|NCT03521817|FG001|Participant Flow|No Alcohol|"No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat).~No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol"
11333983|NCT03521817|OG000|Outcome|Alcohol|"Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the ~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila).~Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol."
11333984|NCT03521817|OG001|Outcome|No Alcohol|"No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat).~No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol"
11333985|NCT03521817|EG000|Reported Event|Alcohol|"Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the ~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila).~Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol."
11333986|NCT03521817|EG001|Reported Event|No Alcohol|"No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat).~No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol"
11333987|NCT03522350|BG000|Baseline|All Study Participants|This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope +
11333988|NCT03522350|FG000|Participant Flow|Embryoscope +|Embryoscope +
11333989|NCT03522350|FG001|Participant Flow|Embryoscope|Embryoscope
11333990|NCT03522350|OG000|Outcome|Embryoscope +|Embryoscope +
11333991|NCT03522350|OG001|Outcome|Embryoscope|Embryoscope
11333992|NCT03522350|EG000|Reported Event|All Participants Enrolled|All participants enrolled and randomized to Embryoscope and Embryoscope+
11333993|NCT03522441|BG000|Baseline|Clindamycin 1% Gel (Akorn Pharmaceuticals)|Clindamycin 1% Gel: Topical gel
11333994|NCT03522441|BG001|Baseline|Clindamycin 1% Gel (Greenstone LLC)|Clindamycin 1% Gel: Topical gel
11333995|NCT03522441|BG002|Baseline|Placebo|Placebo: Topical Placebo gel
11333996|NCT03522441|BG003|Baseline|Total|Total of all reporting groups
11333997|NCT03522441|FG000|Participant Flow|Clindamycin 1% Gel (Akorn Pharmaceuticals)|Clindamycin 1% Gel: Topical gel
11333998|NCT03522441|FG001|Participant Flow|Clindamycin 1% Gel (Greenstone LLC)|Clindamycin 1% Gel: Topical gel
11333999|NCT03522441|FG002|Participant Flow|Placebo|Placebo: Topical Placebo gel
11334000|NCT03522441|OG000|Outcome|Clindamycin 1% Gel (Akorn Pharmaceuticals)|Clindamycin 1% Gel: Topical gel
11334001|NCT03522441|OG001|Outcome|Clindamycin 1% Gel (Greenstone LLC)|Clindamycin 1% Gel: Topical gel
11334002|NCT03522441|OG002|Outcome|Placebo|Placebo: Topical Placebo gel
11334003|NCT03522441|EG000|Reported Event|Clindamycin 1% Gel (Akorn Pharmaceuticals)|Clindamycin 1% Gel: Topical gel
11334004|NCT03522441|EG001|Reported Event|Clindamycin 1% Gel (Greenstone LLC)|Clindamycin 1% Gel: Topical gel
11334005|NCT03522441|EG002|Reported Event|Placebo|Placebo: Topical Placebo gel
11334006|NCT03522506|BG000|Baseline|TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg|TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 4.
11336405|NCT03565887|EG001|Reported Event|Vehicle Ophthalmic Solution|One drop each eye QD in the morning (n=55)
11334007|NCT03522506|BG001|Baseline|TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo|TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 4.
11334008|NCT03522506|BG002|Baseline|Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg|Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
11334009|NCT03522506|BG003|Baseline|Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg|Placebo, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
11334010|NCT03522506|BG004|Baseline|Total|Total of all reporting groups
11334011|NCT03522506|FG000|Participant Flow|TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg|TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 4.
11334012|NCT03522506|FG001|Participant Flow|TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo|TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 4.
11334013|NCT03522506|FG002|Participant Flow|Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg|Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
11334014|NCT03522506|FG003|Participant Flow|Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg|Placebo, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
11334015|NCT03522506|OG000|Outcome|Placebo|Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334016|NCT03522506|OG001|Outcome|TAK-925 44 mg|TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334017|NCT03522506|OG002|Outcome|TAK-925 112 mg|TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334018|NCT03522506|OG003|Outcome|Modafinil 300 mg|Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334019|NCT03522506|OG000|Outcome|TAK-925 44 mg|TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334020|NCT03522506|OG001|Outcome|TAK-925 112 mg|TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334021|NCT03522506|OG000|Outcome|Placebo|Placebo, once on Day 1 of Intervention Periods 1 to 4.
11334022|NCT03522506|OG003|Outcome|Modafinil 300 mg|Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Periods 1 to 4.
11334023|NCT03522506|EG000|Reported Event|Placebo|Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334024|NCT03522506|EG001|Reported Event|TAK-925 44 mg|TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334025|NCT03522506|EG002|Reported Event|TAK-925 112 mg|TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334026|NCT03522506|EG003|Reported Event|Modafinil 300 mg|Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
11334027|NCT03522675|BG000|Baseline|NeoMatriX and Two Comparators|"NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)~NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing"
11334028|NCT03522675|FG000|Participant Flow|NeoMatriX and Two Comparators|"NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)~NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing"
11334029|NCT03522675|OG000|Outcome|NeoMatriX Alone|"NeoMatriX Wound Matrix Collagen Dressing 8mm disc~NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing"
11334030|NCT03522675|OG001|Outcome|Positive Control|Histamine positive control (0.1mL)
11334031|NCT03522675|OG002|Outcome|Negative Control|Normal saline negative control (0.1mL)
11334032|NCT03522675|EG000|Reported Event|NeoMatriX Alone|"NeoMatriX Wound Matrix Collagen Dressing 8mm disc~NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing"
11334033|NCT03522675|EG001|Reported Event|Histamine + NeoMatriX|NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL)
11334034|NCT03522675|EG002|Reported Event|Saline + NeoMatriX|"NeoMatriX Wound Matrix Collagen Dressing 8mm disc~Normal saline negative control (0.1mL)"
11334035|NCT03522948|BG000|Baseline|Open Pilot|"The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.~Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use"
11334036|NCT03522948|FG000|Participant Flow|Open Pilot|"The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.~Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use"
11334037|NCT03522948|OG000|Outcome|Open Pilot|"The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.~Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use"
11334038|NCT03522948|EG000|Reported Event|Open Pilot|"The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men.~Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM: Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use"
11334039|NCT03523715|BG000|Baseline|Prunes|"The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.~Prunes: 12 oz of prunes daily~Docusate Sodium: Oral docusate sodium twice daily"
11334040|NCT03523715|BG001|Baseline|Control|"The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.~Docusate Sodium: Oral docusate sodium twice daily"
11334041|NCT03523715|BG002|Baseline|Total|Total of all reporting groups
11334042|NCT03523715|FG000|Participant Flow|Prunes|"The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.~Prunes: 12 oz of prunes daily~Docusate Sodium: Oral docusate sodium twice daily"
11334043|NCT03523715|FG001|Participant Flow|Control|"The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.~Docusate Sodium: Oral docusate sodium twice daily"
11334044|NCT03523715|OG000|Outcome|Prunes|"The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.~Prunes: 12 oz of prunes daily~Docusate Sodium: Oral docusate sodium twice daily"
11334045|NCT03523715|OG001|Outcome|Control|"The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.~Docusate Sodium: Oral docusate sodium twice daily"
11334046|NCT03523715|EG000|Reported Event|Prunes|"The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.~Prunes: 12 oz of prunes daily~Docusate Sodium: Oral docusate sodium twice daily"
11334047|NCT03523715|EG001|Reported Event|Control|"The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.~Docusate Sodium: Oral docusate sodium twice daily"
11334048|NCT03523871|BG000|Baseline|Post Lung Transplant Patients|"The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.~Mavyret: Patients will be on 8 weeks of Mavyret"
11334049|NCT03523871|FG000|Participant Flow|Post Lung Transplant Patients|"The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.~Mavyret: Patients will be on 8 weeks of Mavyret"
11334050|NCT03523871|OG000|Outcome|Post Lung Transplant Patients|"The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.~Mavyret: Patients will be on 8 weeks of Mavyret"
11334051|NCT03523871|EG000|Reported Event|Post Lung Transplant Patients|"The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.~Mavyret: Patients will be on 8 weeks of Mavyret"
11334052|NCT03523988|BG000|Baseline|Acetaminophen|"Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule"
11334053|NCT03523988|BG001|Baseline|Ibuprofen|"Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Ibuprofen: Ibuprofen gel capsule"
11334054|NCT03523988|BG002|Baseline|Acetaminophen and Ibuprofen|"Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule~Ibuprofen: Ibuprofen gel capsule"
11334055|NCT03523988|BG003|Baseline|Total|Total of all reporting groups
11334056|NCT03523988|FG000|Participant Flow|Acetaminophen|"Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule"
11334057|NCT03523988|FG001|Participant Flow|Ibuprofen|"Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Ibuprofen: Ibuprofen gel capsule"
11334058|NCT03523988|FG002|Participant Flow|Acetaminophen and Ibuprofen|"Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule~Ibuprofen: Ibuprofen gel capsule"
11334059|NCT03523988|OG000|Outcome|Acetaminophen|"Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule"
11334060|NCT03523988|OG001|Outcome|Ibuprofen|"Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Ibuprofen: Ibuprofen gel capsule"
11334061|NCT03523988|OG002|Outcome|Acetaminophen and Ibuprofen|"Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule~Ibuprofen: Ibuprofen gel capsule"
11334062|NCT03523988|EG000|Reported Event|Acetaminophen|"Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule"
11334063|NCT03523988|EG001|Reported Event|Ibuprofen|"Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Ibuprofen: Ibuprofen gel capsule"
11334064|NCT03523988|EG002|Reported Event|Acetaminophen and Ibuprofen|"Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment~Acetaminophen: Acetaminophen gel capsule~Ibuprofen: Ibuprofen gel capsule"
11334065|NCT03524157|BG000|Baseline|PRO-087|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334066|NCT03524157|BG001|Baseline|Xyel Ofteno|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334067|NCT03524157|BG002|Baseline|Systane Ultra|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.~Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334068|NCT03524157|BG003|Baseline|Total|Total of all reporting groups
11334069|NCT03524157|FG000|Participant Flow|PRO-087|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334070|NCT03524157|FG001|Participant Flow|Xyel Ofteno|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334071|NCT03524157|FG002|Participant Flow|Systane Ultra|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.~Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334072|NCT03524157|OG000|Outcome|PRO-087|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334073|NCT03524157|OG001|Outcome|Xyel Ofteno|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334074|NCT03524157|OG002|Outcome|Systane Ultra|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.~Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334075|NCT03524157|EG000|Reported Event|PRO-087|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334076|NCT03524157|EG001|Reported Event|Xyel Ofteno|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.~Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11334077|NCT03524157|EG002|Reported Event|Systane Ultra|"Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.~Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13."
11336592|NCT03569033|OG000|Outcome|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.
10849226|NCT00295009|FG000|Participant Flow|1-Level Fusion|Circumferential fusion at a single lumbar level.
11334078|NCT03524339|BG000|Baseline|Placebo|Placebo oral capsule: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334079|NCT03524339|BG001|Baseline|Tamsulosin|Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334080|NCT03524339|BG002|Baseline|Total|Total of all reporting groups
11334081|NCT03524339|FG000|Participant Flow|Placebo|Placebo oral capsule: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334082|NCT03524339|FG001|Participant Flow|Tamsulosin|Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334083|NCT03524339|OG000|Outcome|Placebo|Placebo oral capsule: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334084|NCT03524339|OG001|Outcome|Tamsulosin|Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334085|NCT03524339|EG000|Reported Event|Placebo|Placebo oral capsule: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334086|NCT03524339|EG001|Reported Event|Tamsulosin|Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
11334087|NCT03525119|BG000|Baseline|HAV Vaccine 1.0 ml + Placebo/ Placebo|HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
11334088|NCT03525119|BG001|Baseline|TDV 0.5 ml + Placebo/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334089|NCT03525119|BG002|Baseline|TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334090|NCT03525119|BG003|Baseline|Total|Total of all reporting groups
11334091|NCT03525119|FG000|Participant Flow|HAV Vaccine 1.0 ml + Placebo/ Placebo|HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
11334092|NCT03525119|FG001|Participant Flow|TDV 0.5 ml + Placebo/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334093|NCT03525119|FG002|Participant Flow|TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334094|NCT03525119|OG000|Outcome|HAV Vaccine 1.0 ml + Placebo/ Placebo|HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
11334095|NCT03525119|OG001|Outcome|TDV 0.5 ml + Placebo/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334096|NCT03525119|OG002|Outcome|TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334097|NCT03525119|EG000|Reported Event|HAV Vaccine 1.0 ml + Placebo/ Placebo|HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
11334098|NCT03525119|EG001|Reported Event|TDV 0.5 ml + Placebo/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334099|NCT03525119|EG002|Reported Event|TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml|TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
11334100|NCT03525210|BG000|Baseline|HIV Patients|"All HIV patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334101|NCT03525210|BG001|Baseline|SOT Patients|"All SOT patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334102|NCT03525210|BG002|Baseline|Total|Total of all reporting groups
11334103|NCT03525210|FG000|Participant Flow|HIV Patients|"All HIV patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334104|NCT03525210|FG001|Participant Flow|SOT Patients|"All SOT patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334105|NCT03525210|OG000|Outcome|HIV Patients|"All HIV patients will receive the study vaccines~9-valent HPV vaccine: Vaccination~Number and proportion of patients with adverse events."
11334106|NCT03525210|OG001|Outcome|SOT Patients|"All SOT patients will receive the study vaccines~9-valent HPV vaccine: Vaccination~Number and proportion of patients with adverse events."
11334107|NCT03525210|OG000|Outcome|HIV Patients|"All HIV patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334108|NCT03525210|OG001|Outcome|SOT Patients|"All SOT patients will receive the study vaccines~9-valent HPV vaccine: Vaccination"
11334109|NCT03525210|EG000|Reported Event|HIV Patients|"All HIV patients will receive the study vaccines~9-valent HPV vaccine: Vaccination~Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved."
11334110|NCT03525210|EG001|Reported Event|SOT Patients|"All SOT patients will receive the study vaccines~9-valent HPV vaccine: Vaccination~Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved."
11334111|NCT03525444|BG000|Baseline|Placebo|Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11334112|NCT03525444|BG001|Baseline|VX-445/TEZ/IVA TC|Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11334113|NCT03525444|BG002|Baseline|Total|Total of all reporting groups
10850823|NCT04511338|OG001|Outcome|Circuit B|Dialyzer with Endexo + Streamline bloodline
10850824|NCT04511338|EG000|Reported Event|Circuit A|Dialyzer with Endexo + CombiSet bloodline
10850825|NCT04511338|EG001|Reported Event|Circuit B|Dialyzer with Endexo + Streamline bloodline
10850826|NCT04496414|BG000|Baseline|Bactiseal Catheter Arm|Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
10850827|NCT04496414|FG000|Participant Flow|Bactiseal Catheter Arm|Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
10850828|NCT04496414|OG000|Outcome|Bactiseal Catheter Arm|Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
10850829|NCT04496414|EG000|Reported Event|Bactiseal Catheter Arm|Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
10850830|NCT04493931|BG000|Baseline|Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine.
10850831|NCT04493931|BG001|Baseline|Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin.
10850832|NCT04493931|BG002|Baseline|Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam|Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.
10850833|NCT04493931|BG003|Baseline|Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam|Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.
10850834|NCT04493931|BG004|Baseline|Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 followed by a washout of 3 days . In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.
10850835|NCT04493931|BG005|Baseline|Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.
10850836|NCT04493931|BG006|Baseline|Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed|Japanese participants received a single dose of placebo matching gepotidacin under fed conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of placebo matching gepotidacin under fasted conditions on Day 1 of Period 2, followed by a washout of 3 days. In Period 3, participants were administered with two doses of placebo matching gepotidacin (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days.
10850837|NCT04493931|BG007|Baseline|Total|Total of all reporting groups
10850838|NCT04493931|FG000|Participant Flow|Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine.
10850839|NCT04493931|FG001|Participant Flow|Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin.
10850840|NCT04493931|FG002|Participant Flow|Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam|Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.
10850841|NCT04493931|FG003|Participant Flow|Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam|Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.
10850867|NCT04493931|EG005|Reported Event|Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg|Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 and Period 2 in Cohort 3.
11334114|NCT03525444|FG000|Participant Flow|Placebo|Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11334115|NCT03525444|FG001|Participant Flow|VX-445/TEZ/IVA TC|Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11334116|NCT03525444|OG000|Outcome|Placebo|Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11334117|NCT03525444|OG001|Outcome|VX-445/TEZ/IVA TC|Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11334118|NCT03525444|OG000|Outcome|VX-445/TEZ/IVA TC|Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11334119|NCT03525444|EG000|Reported Event|Placebo|Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
11334120|NCT03525444|EG001|Reported Event|VX-445/TEZ/IVA TC|Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
11334121|NCT03525548|BG000|Baseline|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334122|NCT03525548|BG001|Baseline|VX-445/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334123|NCT03525548|BG002|Baseline|Total|Total of all reporting groups
11334124|NCT03525548|FG000|Participant Flow|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334125|NCT03525548|FG001|Participant Flow|VX-445/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334126|NCT03525548|OG000|Outcome|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334127|NCT03525548|OG001|Outcome|VX-445/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334128|NCT03525548|EG000|Reported Event|TEZ/IVA|Following a run-in period of 4 weeks with TEZ/IVA, participants received TEZ 100 mg/IVA 150 mg as FDC tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334129|NCT03525548|EG001|Reported Event|VX-445/TEZ/IVA TC|Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
11334130|NCT03525834|BG000|Baseline|Everolimus|Participants targeted to receive Everolimus tablets 10 mg once daily for 48 weeks.
11334131|NCT03525834|FG000|Participant Flow|Everolimus|Participants targeted to receive Everolimus tablets 10 mg once daily for 48 weeks.
11334132|NCT03525834|OG000|Outcome|Everolimus|Participants targeted to receive Everolimus tablets 10 mg once daily for 48 weeks.
11334133|NCT03525834|EG000|Reported Event|Everolimus|Participants targeted to receive Everolimus tablets 10 mg once daily for 48 weeks.
11334134|NCT03526055|BG000|Baseline|Entire Study Population|Crossover study design, all participant data is collected together.
11334135|NCT03526055|FG000|Participant Flow|<500 µS Pulse Width First, Then >1000 µS Pulse Width|"Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
11334136|NCT03526055|FG001|Participant Flow|>1000 µS Pulse Width First, Then <500 µS Pulse Width|"Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
11334137|NCT03526055|OG000|Outcome|<500 µS Pulse Width|"Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
11334138|NCT03526055|OG001|Outcome|>1000 µS Pulse Width|"Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.~Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain."
11334139|NCT03526055|OG000|Outcome|Entire Study Population|Crossover study design, all participant data is collected together.
11334140|NCT03526055|EG000|Reported Event|<500 μS Pulse Width|Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
11334141|NCT03526055|EG001|Reported Event|>1000 μS Pulse Width|Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
11334142|NCT03526458|BG000|Baseline|Holmium:YAG Laser: 0.2J&15Hz|"Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334143|NCT03526458|BG001|Baseline|Holmium:YAG Laser: 0.8J&15Hz|"Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334144|NCT03526458|BG002|Baseline|Total|Total of all reporting groups
11334145|NCT03526458|FG000|Participant Flow|Holmium:YAG Laser: 0.2J&15Hz|"Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334146|NCT03526458|FG001|Participant Flow|Holmium:YAG Laser: 0.8J&15Hz|"Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334147|NCT03526458|OG000|Outcome|Holmium:YAG Laser: 0.2J&15Hz|"Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334148|NCT03526458|OG001|Outcome|Holmium:YAG Laser: 0.8J&15Hz|"Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334149|NCT03526458|EG000|Reported Event|Holmium:YAG Laser: 0.2J&15Hz|"Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334150|NCT03526458|EG001|Reported Event|Holmium:YAG Laser: 0.8J&15Hz|"Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.~Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)"
11334151|NCT03526861|BG000|Baseline|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11334152|NCT03526861|BG001|Baseline|Initial Treatment Period - Tralokinumab 150 mg Q2W|"Week 0 to Week 16:~Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.~At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab."
11334153|NCT03526861|BG002|Baseline|Initial Treatment Period - Placebo|"Week 0 to Week 16:~Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo."
11334154|NCT03526861|BG003|Baseline|Total|Total of all reporting groups
11334155|NCT03526861|FG000|Participant Flow|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11335390|NCT03549429|BG001|Baseline|TegadermTM on L Eye, EyeGard® on R Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11335391|NCT03549429|BG002|Baseline|Total|Total of all reporting groups
10843330|NCT00253708|FG000|Participant Flow|Touch Intervention (Massage Therapy)|Patients received three visits by the professional massage therapists over the first week after the enrollment. Massage treatments were scheduled based on patient preferences, and the duration was between 15 and 45 minutes; both the duration and the amount of pressure was modified depending on patient comfort. A limited scope of practice was provided to the massage therapists that specified the allowed and disallowed massage modalities and techniques. Allowed techniques were both Swedish and non-Swedish massage including gliding/effleurage, gentle kneading/petrissage, compression, gentle stretching, rocking, light myofascial release, active and/or passive range of motion, warm or cool applications, and use of acupressure points as well as craniosacral holds thought to have calming and centering effects. No forms of friction, deep-tissue massage, or bodywork forms that required movement by the patients were allowed.
10843331|NCT00253708|FG001|Participant Flow|No Touch Intervention (Control)|The authors wanted to separate out the effect of interacting with a massage therapist from massage itself, so the therapists performed no-touch control interventions, which had no healing intention. Although most of the therapists had experience with energy healing, the therapists were trained to avoid ''healing intention'' in the no-touch group by using distraction if necessary, created by counting backwards. For the no-touch control intervention, therapists were instructed to be with the patients between 15 and 45 minutes, depending on the patient's tolerance, and to hold their hands about 12 inches over the patient's body. In the usual-care control group, patients completed the same questionnaires but did not receive any visits from the massage therapists.
10843332|NCT00253708|FG002|Participant Flow|Usual Care (Control)|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
10843333|NCT00253708|OG000|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10843334|NCT00253708|OG001|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10843335|NCT00253708|OG002|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
10843336|NCT00253708|EG000|Reported Event|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10843337|NCT00253708|EG001|Reported Event|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
10843338|NCT00253708|EG002|Reported Event|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
10843339|NCT00253747|BG000|Baseline|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843340|NCT00253747|BG001|Baseline|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843341|NCT00253747|BG002|Baseline|Total|Total of all reporting groups
10843342|NCT00253747|FG000|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843343|NCT00253747|FG001|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843344|NCT00253747|OG000|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843345|NCT00253747|OG001|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843346|NCT00253747|OG000|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Baseline|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10845129|NCT00265317|BG002|Baseline|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
11334156|NCT03526861|FG001|Participant Flow|Initial Treatment Period - Tralokinumab 150 mg Q2W|"Week 0 to Week 16:~Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration.~At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab."
11334157|NCT03526861|FG002|Participant Flow|Initial Treatment Period - Placebo|"Week 0 to Week 16:~Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo."
11334158|NCT03526861|FG003|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11334159|NCT03526861|FG004|Participant Flow|Maintenance Treatment Period - Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo."
11334160|NCT03526861|FG005|Participant Flow|Maintenance Treatment Period - Tralokinumab 150 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab."
11334161|NCT03526861|FG006|Participant Flow|Maintenance Treatment Period - Tralokinumab 150 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo."
11334162|NCT03526861|FG007|Participant Flow|Maintenance Treatment Period - Placebo Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to placebo, assigned to continue to placebo Q2W. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of placebo."
11334163|NCT03526861|FG008|Participant Flow|Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS|"Week 16 to Week 52:~Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if~IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16.~IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16.~Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg."
11334164|NCT03526861|OG000|Outcome|Initial Treatment Period - Tralokinumab 300 mg Q2W|"Week 0 to Week 16:~Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11334165|NCT03526861|OG001|Outcome|Initial Treatment Period - Tralokinumab 150 mg Q2W|"Week 0 to Week 16:~Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.~At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab."
11334166|NCT03526861|OG002|Outcome|Initial Treatment Period - Placebo|"Week 0 to Week 16:~Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.~At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo."
11334167|NCT03526861|OG000|Outcome|Maintenance Treatment Period - Tralokinumab 300 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab."
11335392|NCT03549429|FG000|Participant Flow|TegadermTM on R Eye, EyeGard® on L Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11334168|NCT03526861|OG001|Outcome|Maintenance Treatment Period - Tralokinumab 300 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo."
11334169|NCT03526861|OG002|Outcome|Maintenance Treatment Period - Tralokinumab 150 mg Q2W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab."
11334170|NCT03526861|OG003|Outcome|Maintenance Treatment Period - Tralokinumab 150 mg Q4W|"Week 16 to Week 52:~Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo."
11334171|NCT03526861|OG004|Outcome|Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS|"Week 16 to Week 52:~Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if~IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16.~IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16.~Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg."
11334172|NCT03526861|EG000|Reported Event|Initial Treatment Period - Tralokinumab 300 Q2W|Initial Treatment Period - Tralokinumab 300 Q2W (n=97, PYE=29.48)
11334173|NCT03526861|EG001|Reported Event|Initial Treatment Period - Tralokinumab 150 Q2W|Initial Treatment Period - Tralokinumab 150 Q2W (n=98, PYE=29.33)
11334174|NCT03526861|EG002|Reported Event|Initial Treatment Period - Placebo|Initial Treatment Period - Placebo (n=94, PYE=27.93)
11334175|NCT03526861|EG003|Reported Event|Maintenance Treatment Period - Tralokinumab 300 Q2W|Maintenance Treatment Period - Tralokinumab 300 Q2W (n=11, PYE=5.61)
11334176|NCT03526861|EG004|Reported Event|Maintenance Treatment Period - Tralokinumab 300 Q4W|Maintenance Treatment Period - Tralokinumab 300 Q4W (n=13, PYE=6.78)
11334177|NCT03526861|EG005|Reported Event|Maintenance Treatment Period - Tralokinumab 150 Q2W|Maintenance Treatment Period - Tralokinumab 150 Q2W (n=12, PYE=6.40)
11334178|NCT03526861|EG006|Reported Event|Maintenance Treatment Period - Tralokinumab 150 Q4W|Maintenance Treatment Period - Tralokinumab 150 Q4W (n=14, PYE=6.53)
11334179|NCT03526861|EG007|Reported Event|Maintenance Treatment Period - Placebo|Maintenance Treatment Period - Placebo (n=6, PYE=2.98)
11334180|NCT03526861|EG008|Reported Event|Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS|Open-label Treatment - Tralokinumab 300 Q2W + optional TCS (n=234, PYE=151.12)
11334181|NCT03526861|EG009|Reported Event|Safety Follow-up|Safety Follow-up (n=234, PYE=54.00)
11334182|NCT03527160|BG000|Baseline|Any AKI|Patients developed AKI during study
11334183|NCT03527160|BG001|Baseline|No AKI|Patients did not develop AKI over the course of the study
11334184|NCT03527160|BG002|Baseline|Total|Total of all reporting groups
11334185|NCT03527160|FG000|Participant Flow|NINJA|Inpatients exposed to nephrotoxic medications
11334186|NCT03527160|OG000|Outcome|Any AKI|Patients developed Nephrotoxic Medication Associated AKI during study
11334187|NCT03527160|OG001|Outcome|No AKI|Patients did not develop Nephrotoxic Medication Associated AKI over the course of the study
11334188|NCT03527160|OG000|Outcome|NGAL >= 150 ng/mL|Participants who had an elevated point of care urine NGAL
11334189|NCT03527160|OG001|Outcome|NGAL<150 ng/mL|Point of care urine NGAL less than 150 ng/mL
11334190|NCT03527160|EG000|Reported Event|NINJA|Inpatients exposed to nephrotoxic medications
11334191|NCT03527173|BG000|Baseline|S. Sonnei Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334192|NCT03527173|BG001|Baseline|Placebo Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334193|NCT03527173|BG002|Baseline|Total|Total of all reporting groups
11334194|NCT03527173|FG000|Participant Flow|S. Sonnei Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334195|NCT03527173|FG001|Participant Flow|Placebo Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11336406|NCT03566238|BG000|Baseline|A4250 Low Dose|"Capsules for oral administration (40 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11334196|NCT03527173|OG000|Outcome|S. Sonnei Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334197|NCT03527173|OG001|Outcome|Placebo Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334198|NCT03527173|EG000|Reported Event|S. Sonnei Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334199|NCT03527173|EG001|Reported Event|Placebo Group|Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
11334200|NCT03527550|BG000|Baseline|Cognitive Training Plus Treatment as Usual|"Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training.~Cognitive Control Training: Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen."
11334201|NCT03527550|BG001|Baseline|Treatment as Usual (TAU)|Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
11334202|NCT03527550|BG002|Baseline|Total|Total of all reporting groups
11334203|NCT03527550|FG000|Participant Flow|Cognitive Training Plus Treatment as Usual|"Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training.~Cognitive Control Training: Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen."
11334204|NCT03527550|FG001|Participant Flow|Treatment as Usual (TAU)|Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
11334205|NCT03527550|OG000|Outcome|Cognitive Training Plus Treatment as Usual|"Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training.~Cognitive Control Training: Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen."
11334206|NCT03527550|OG001|Outcome|Treatment as Usual|Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
11334207|NCT03527550|OG000|Outcome|Cognitive Training Plus Treatment as Usual|"Participants in this arm will receive daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions will alternate between response inhibition training and working memory training.~Cognitive Control Training: Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen."
11334208|NCT03527550|OG001|Outcome|Treatment as Usual (TAU)|Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
11334209|NCT03527550|EG000|Reported Event|Cognitive Training Plus Treatment as Usual|"Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training.~Cognitive Control Training: Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen."
11334210|NCT03527550|EG001|Reported Event|Treatment as Usual|Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
11334211|NCT03527745|BG000|Baseline|Placebo Against T. Trichiura in PSAC|Placebo against T. trichiura in preschool-aged children
11334212|NCT03527745|BG001|Baseline|ALB 200 mg Against T. Trichiura in PSAC|200 mg of albendazole against T. trichiura in preschool-aged children
11334213|NCT03527745|BG002|Baseline|ALB 400 mg Against T. Trichiura in PSAC|400 mg of albendazole against T. trichiura in preschool-aged children
11334214|NCT03527745|BG003|Baseline|ALB 600 mg Against T. Trichiura in PSAC|600 mg of albendazole against T. trichiura in preschool-aged children
11334215|NCT03527745|BG004|Baseline|Placebo Against T. Trichiura in SAC|Placebo against T. trichiura in school-aged children
11334216|NCT03527745|BG005|Baseline|ALB 400 mg Against T. Trichiura in SAC|400 mg of albendazole against T. trichiura in school-aged children
11334217|NCT03527745|BG006|Baseline|ALB 600 mg Against T. Trichiura in SAC|600 mg of albendazole against T. trichiura in school-aged children
11334218|NCT03527745|BG007|Baseline|ALB 800 mg Against T. Trichiura in SAC|800 mg of albendazole against T. trichiura in school-aged children
11334219|NCT03527745|BG008|Baseline|Placebo Against T. Trichiura in Adults|Placebo against T. trichiura in adults (>21 years)
11334220|NCT03527745|BG009|Baseline|ALB 400 mg Against T. Trichiura in Adults|400 mg of albendazole against T. trichiura in adults
11334221|NCT03527745|BG010|Baseline|ALB 600 mg Against T. Trichiura in Adults|600 mg of albendazole against T. trichiura in adults
11334222|NCT03527745|BG011|Baseline|ALB 800 mg Against T. Trichiura in Adults|800 mg of albendazole against T. trichiura in adults
11334223|NCT03527745|BG012|Baseline|Placebo Against Hookworm in PSAC|Placebo against hookworm in preschool-aged children
11334224|NCT03527745|BG013|Baseline|ALB 200 mg Against Hookworm in PSAC|200 mg of albendazole against hookworm in preschool-aged children
11334225|NCT03527745|BG014|Baseline|ALB 400 mg Against Hookworm in PSAC|400 mg of albendazole against hookworm in preschool-aged children
11334226|NCT03527745|BG015|Baseline|ALB 600 mg Against Hookworm in PSAC|600 mg of albendazole against hookworm in preschool-aged children
11334227|NCT03527745|BG016|Baseline|Placebo Against Hookworm in SAC|Placebo against hookworm in school-aged children
11334228|NCT03527745|BG017|Baseline|ALB 200 mg Against Hookworm in SAC|200 mg of albendazole against hookworm in school-aged children
11334229|NCT03527745|BG018|Baseline|ALB 400 mg Against Hookworm in SAC|400 mg of albendazole against hookworm in school-aged children
11334230|NCT03527745|BG019|Baseline|ALB 600 mg Against Hookworm in SAC|600 mg of albendazole against hookworm in school-aged children
11334231|NCT03527745|BG020|Baseline|ALB 800 mg Against Hookworm in SAC|800 mg of albendazole against hookworm in school-aged children
11334232|NCT03527745|BG021|Baseline|Placebo Against Hookworm in Adults|Placebo against hookworm in adults (>21 years)
11334233|NCT03527745|BG022|Baseline|ALB 200 mg Against Hookworm in Adults|200 mg of albendazole against hookworm in adults
11334234|NCT03527745|BG023|Baseline|ALB 400 mg Against Hookworm in Adults|400 mg of albendazole against hookworm in adults
11334235|NCT03527745|BG024|Baseline|ALB 600 mg Against Hookworm in Adults|600 mg of albendazole against hookworm in adults
11334236|NCT03527745|BG025|Baseline|ALB 800 mg Against Hookworm in Adults|800 mg of albendazole against hookworm in adults
11334237|NCT03527745|BG026|Baseline|Total|Total of all reporting groups
11334238|NCT03527745|FG000|Participant Flow|Placebo Against T. Trichiura in PSAC|Placebo against T. trichiura in preschool-aged children
11334239|NCT03527745|FG001|Participant Flow|ALB 200 mg Against T. Trichiura in PSAC|200 mg of albendazole against T. trichiura in preschool-aged children
11334240|NCT03527745|FG002|Participant Flow|ALB 400 mg Against T. Trichiura in PSAC|400 mg of albendazole against T. trichiura in preschool-aged children
11334241|NCT03527745|FG003|Participant Flow|ALB 600 mg Against T. Trichiura in PSAC|600 mg of albendazole against T. trichiura in preschool-aged children
11334242|NCT03527745|FG004|Participant Flow|Placebo Against T. Trichiura in SAC|Placebo against T. trichiura in school-aged children
11334243|NCT03527745|FG005|Participant Flow|ALB 400 mg Against T. Trichiura in SAC|400 mg of albendazole against T. trichiura in school-aged children
11334244|NCT03527745|FG006|Participant Flow|ALB 600 mg Against T. Trichiura in SAC|600 mg of albendazole against T. trichiura in school-aged children
11334245|NCT03527745|FG007|Participant Flow|ALB 800 mg Against T. Trichiura in SAC|800 mg of albendazole against T. trichiura in school-aged children
11334246|NCT03527745|FG008|Participant Flow|Placebo Against T. Trichiura in Adults|Placebo against T. trichiura in adults
11334247|NCT03527745|FG009|Participant Flow|ALB 400 mg Against T. Trichiura in Adults|400 mg of albendazole against T. trichiura in adults
11334248|NCT03527745|FG010|Participant Flow|ALB 600 mg Against T. Trichiura in Adults|600 mg of albendazole against T. trichiura in adults
11334249|NCT03527745|FG011|Participant Flow|ALB 800 mg Against T. Trichiura in Adults|800 mg of albendazole against T. trichiura in adults
11334250|NCT03527745|FG012|Participant Flow|Placebo Against Hookworm in PSAC|Placebo against hookworm in preschool-aged children
11334251|NCT03527745|FG013|Participant Flow|ALB 200 mg Against Hookworm in PSAC|200 mg of albendazole against hookworm in preschool-aged children
11334252|NCT03527745|FG014|Participant Flow|ALB 400 mg Against Hookworm in PSAC|400 mg of albendazole against hookworm in preschool-aged children
11334253|NCT03527745|FG015|Participant Flow|ALB 600 mg Against Hookworm in PSAC|600 mg of albendazole against hookworm in preschool-aged children
11334254|NCT03527745|FG016|Participant Flow|Placebo Against Hookworm in SAC|Placebo against hookworm in school-aged children
11334255|NCT03527745|FG017|Participant Flow|ALB 200 mg Against Hookworm in SAC|200 mg of albendazole against hookworm in school-aged children
11334256|NCT03527745|FG018|Participant Flow|ALB 400 mg Against Hookworm in SAC|400 mg of albendazole against hookworm in school-aged children
11334257|NCT03527745|FG019|Participant Flow|ALB 600 mg Against Hookworm in SAC|600 mg of albendazole against hookworm in school-aged children
11334258|NCT03527745|FG020|Participant Flow|ALB 800 mg Against Hookworm in SAC|800 mg of albendazole against hookworm in school-aged children
11334259|NCT03527745|FG021|Participant Flow|Placebo Against Hookworm in Adults|Placebo against hookworm in adults
11334260|NCT03527745|FG022|Participant Flow|ALB 200 mg Against Hookworm in Adults|200 mg of albendazole against hookworm in adults
11334261|NCT03527745|FG023|Participant Flow|ALB 400 mg Against Hookworm in Adults|400 mg of albendazole against hookworm in adults
11334262|NCT03527745|FG024|Participant Flow|ALB 600 mg Against Hookworm in Adults|600 mg of albendazole against hookworm in adults
11334263|NCT03527745|FG025|Participant Flow|ALB 800 mg Against Hookworm in Adults|800 mg of albendazole against hookworm in adults
11334264|NCT03527745|OG000|Outcome|Placebo Against T. Trichiura in PSAC|Placebo against T. trichiura in preschool-aged children
11334265|NCT03527745|OG001|Outcome|ALB 200 mg Against T. Trichiura in PSAC|200 mg of albendazole against T. trichiura in preschool-aged children
11334266|NCT03527745|OG002|Outcome|ALB 400 mg Against T. Trichiura in PSAC|400 mg of albendazole against T. trichiura in preschool-aged children
11334267|NCT03527745|OG003|Outcome|ALB 600 mg Against T. Trichiura in PSAC|600 mg of albendazole against T. trichiura in preschool-aged children
11334268|NCT03527745|OG004|Outcome|Placebo Against T. Trichiura in SAC|Placebo against T. trichiura in school-aged children
11334269|NCT03527745|OG005|Outcome|ALB 400 mg Against T. Trichiura in SAC|400 mg of albendazole against T. trichiura in school-aged children
11334270|NCT03527745|OG006|Outcome|ALB 600 mg Against T. Trichiura in SAC|600 mg of albendazole against T. trichiura in school-aged children
11334271|NCT03527745|OG007|Outcome|ALB 800 mg Against T. Trichiura in SAC|800 mg of albendazole against T. trichiura in school-aged children
11334272|NCT03527745|OG008|Outcome|Placebo Against T. Trichiura in Adults|Placebo against T. trichiura in adults
11334273|NCT03527745|OG009|Outcome|ALB 400 mg Against T. Trichiura in Adults|400 mg of albendazole against T. trichiura in adults
11334274|NCT03527745|OG010|Outcome|ALB 600 mg Against T. Trichiura in Adults|600 mg of albendazole against T. trichiura in adults
11334275|NCT03527745|OG011|Outcome|ALB 800 mg Against T. Trichiura in Adults|800 mg of albendazole against T. trichiura in adults
11334276|NCT03527745|OG012|Outcome|Placebo Against Hookworm in PSAC|Placebo against hookworm in preschool-aged children
11334277|NCT03527745|OG013|Outcome|ALB 200 mg Against Hookworm in PSAC|200 mg of albendazole against hookworm in preschool-aged children
11334278|NCT03527745|OG014|Outcome|ALB 400 mg Against Hookworm in PSAC|400 mg of albendazole against hookworm in preschool-aged children
11334279|NCT03527745|OG015|Outcome|ALB 600 mg Against Hookworm in PSAC|600 mg of albendazole against hookworm in preschool-aged children
11334280|NCT03527745|OG016|Outcome|Placebo Against Hookworm in SAC|Placebo against hookworm in school-aged children
11334281|NCT03527745|OG017|Outcome|ALB 200 mg Against Hookworm in SAC|200 mg of albendazole against hookworm in school-aged children
11334282|NCT03527745|OG018|Outcome|ALB 400 mg Against Hookworm in SAC|400 mg of albendazole against hookworm in school-aged children
11334283|NCT03527745|OG019|Outcome|ALB 600 mg Against Hookworm in SAC|600 mg of albendazole against hookworm in school-aged children
11334284|NCT03527745|OG020|Outcome|ALB 800 mg Against Hookworm in SAC|800 mg of albendazole against hookworm in school-aged children
11334285|NCT03527745|OG021|Outcome|Placebo Against Hookworm in Adults|Placebo against hookworm in adults
11334286|NCT03527745|OG022|Outcome|ALB 200 mg Against Hookworm in Adults|200 mg of albendazole against hookworm in adults
11334287|NCT03527745|OG023|Outcome|ALB 400 mg Against Hookworm in Adults|400 mg of albendazole against hookworm in adults
11334288|NCT03527745|OG024|Outcome|ALB 600 mg Against Hookworm in Adults|600 mg of albendazole against hookworm in adults
11334289|NCT03527745|OG025|Outcome|ALB 800 mg Against Hookworm in Adults|800 mg of albendazole against hookworm in adults
11334290|NCT03527745|OG008|Outcome|Placebo Against T. Trichiura in Adults|Placebo against T. trichiura in adults (>21 years)
11334291|NCT03527745|OG021|Outcome|Placebo Against Hookworm in Adults|Placebo against hookworm in adults (>21 years)
11334292|NCT03527745|EG000|Reported Event|Placebo Against T. Trichiura in PSAC|Placebo against T. trichiura in preschool-aged children
11334293|NCT03527745|EG001|Reported Event|ALB 200 mg Against T. Trichiura in PSAC|200 mg of albendazole against T. trichiura in preschool-aged children
11334294|NCT03527745|EG002|Reported Event|ALB 400 mg Against T. Trichiura in PSAC|400 mg of albendazole against T. trichiura in preschool-aged children
11334295|NCT03527745|EG003|Reported Event|ALB 600 mg Against T. Trichiura in PSAC|600 mg of albendazole against T. trichiura in preschool-aged children
11334296|NCT03527745|EG004|Reported Event|Placebo Against T. Trichiura in SAC|Placebo against T. trichiura in school-aged children
11334297|NCT03527745|EG005|Reported Event|ALB 400 mg Against T. Trichiura in SAC|400 mg of albendazole against T. trichiura in school-aged children
11334298|NCT03527745|EG006|Reported Event|ALB 600 mg Against T. Trichiura in SAC|600 mg of albendazole against T. trichiura in school-aged children
11334299|NCT03527745|EG007|Reported Event|ALB 800 mg Against T. Trichiura in SAC|800 mg of albendazole against T. trichiura in school-aged children
11334300|NCT03527745|EG008|Reported Event|Placebo Against T. Trichiura in Adults|Placebo against T. trichiura in adults
11334301|NCT03527745|EG009|Reported Event|ALB 400 mg Against T. Trichiura in Adults|400 mg of albendazole against T. trichiura in adults
11334302|NCT03527745|EG010|Reported Event|ALB 600 mg Against T. Trichiura in Adults|600 mg of albendazole against T. trichiura in adults
11334303|NCT03527745|EG011|Reported Event|ALB 800 mg Against T. Trichiura in Adults|800 mg of albendazole against T. trichiura in adults
11334304|NCT03527745|EG012|Reported Event|Placebo Against Hookworm in PSAC|Placebo against hookworm in preschool-aged children
11334305|NCT03527745|EG013|Reported Event|ALB 200 mg Against Hookworm in PSAC|200 mg of albendazole against hookworm in preschool-aged children
11334306|NCT03527745|EG014|Reported Event|ALB 400 mg Against Hookworm in PSAC|400 mg of albendazole against hookworm in preschool-aged children
11334307|NCT03527745|EG015|Reported Event|ALB 600 mg Against Hookworm in PSAC|600 mg of albendazole against hookworm in preschool-aged children
11334308|NCT03527745|EG016|Reported Event|Placebo Against Hookworm in SAC|Placebo against hookworm in school-aged children
11334309|NCT03527745|EG017|Reported Event|ALB 200 mg Against Hookworm in SAC|200 mg of albendazole against hookworm in school-aged children
11334310|NCT03527745|EG018|Reported Event|ALB 400 mg Against Hookworm in SAC|400 mg of albendazole against hookworm in school-aged children
11334311|NCT03527745|EG019|Reported Event|ALB 600 mg Against Hookworm in SAC|600 mg of albendazole against hookworm in school-aged children
11334312|NCT03527745|EG020|Reported Event|ALB 800 mg Against Hookworm in SAC|800 mg of albendazole against hookworm in school-aged children
11334313|NCT03527745|EG021|Reported Event|Placebo Against Hookworm in Adults|Placebo against hookworm in adults
11334314|NCT03527745|EG022|Reported Event|ALB 200 mg Against Hookworm in Adults|200 mg of albendazole against hookworm in adults
11334315|NCT03527745|EG023|Reported Event|ALB 400 mg Against Hookworm in Adults|400 mg of albendazole against hookworm in adults
11334316|NCT03527745|EG024|Reported Event|ALB 600 mg Against Hookworm in Adults|600 mg of albendazole against hookworm in adults
11334317|NCT03527745|EG025|Reported Event|ALB 800 mg Against Hookworm in Adults|800 mg of albendazole against hookworm in adults
11334318|NCT03527966|BG000|Baseline|Intervention Group - 5cc Vivigen and Local Autograft|5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
11334319|NCT03527966|BG001|Baseline|Control Group - Small Kit rhBMP-2 With Local Autograft|Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
11334320|NCT03527966|BG002|Baseline|Total|Total of all reporting groups
11334321|NCT03527966|FG000|Participant Flow|Intervention Group - 5cc Vivigen and Local Autograft|5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
11334322|NCT03527966|FG001|Participant Flow|Control Group - Small Kit rhBMP-2 With Local Autograft|Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
11334323|NCT03527966|OG000|Outcome|Intervention Group - 5cc Vivigen and Local Autograft|5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
11334324|NCT03527966|OG001|Outcome|Control Group - Small Kit rhBMP-2 With Local Autograft|Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
11334325|NCT03527966|EG000|Reported Event|Intervention Group - 5cc Vivigen and Local Autograft|5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
11334326|NCT03527966|EG001|Reported Event|Control Group - Small Kit rhBMP-2 With Local Autograft|Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
11334327|NCT03528174|BG000|Baseline|Single Hormone Closed Loop|"Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.~Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.~Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system"
11334328|NCT03528174|FG000|Participant Flow|Single Hormone Closed Loop|"Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.~Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.~Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system"
11334329|NCT03528174|OG000|Outcome|Single Hormone Closed Loop|"Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.~Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.~Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system"
11334330|NCT03528174|EG000|Reported Event|Single Hormone Closed Loop|"Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.~Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.~Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system"
11334331|NCT03528369|BG000|Baseline|CGS-200-1|"CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study."
11334332|NCT03528369|BG001|Baseline|CGS-200-5|"CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study."
11334333|NCT03528369|BG002|Baseline|CGS-200 Vehicle|"CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin."
11334334|NCT03528369|BG003|Baseline|Total|Total of all reporting groups
11334335|NCT03528369|FG000|Participant Flow|CGS-200-1|"CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study."
11334336|NCT03528369|FG001|Participant Flow|CGS-200-5|"CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study."
11334337|NCT03528369|FG002|Participant Flow|CGS-200 Vehicle|"CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin."
11334338|NCT03528369|OG000|Outcome|CGS-200-1|"CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study."
11334339|NCT03528369|OG001|Outcome|CGS-200-5|"CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study."
11334340|NCT03528369|OG002|Outcome|CGS-200 Vehicle|"CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin."
11334341|NCT03528369|EG000|Reported Event|CGS-200-1|"CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-1: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study."
11334342|NCT03528369|EG001|Reported Event|CGS-200-5|"CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200-5: CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study."
11334343|NCT03528369|EG002|Reported Event|CGS-200 Vehicle|"CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.~CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin."
11334344|NCT03528512|BG000|Baseline|IN Ketamine|"Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)~Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)"
11334345|NCT03528512|BG001|Baseline|IN Midazolam and Fentanyl|"Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)~Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)"
11334346|NCT03528512|BG002|Baseline|Total|Total of all reporting groups
11334347|NCT03528512|FG000|Participant Flow|IN Ketamine|"Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)~Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)"
11334348|NCT03528512|FG001|Participant Flow|IN Midazolam and Fentanyl|"Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)~Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)"
11334349|NCT03528512|OG000|Outcome|IN Ketamine|"Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)~Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)"
11334350|NCT03528512|OG001|Outcome|IN Midazolam and Fentanyl|"Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)~Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)"
11334351|NCT03528512|EG000|Reported Event|IN Ketamine|"Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)~Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)"
11334352|NCT03528512|EG001|Reported Event|IN Midazolam and Fentanyl|"Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)~Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)"
11334353|NCT03528551|BG000|Baseline|N8-GP, Once Weekly|Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.
11334354|NCT03528551|BG001|Baseline|N8-GP, Twice Weekly|Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
11334355|NCT03528551|BG002|Baseline|N8-GP, Three Times Weekly|Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
11334356|NCT03528551|BG003|Baseline|Total|Total of all reporting groups
11334357|NCT03528551|FG000|Participant Flow|N8-GP, Once Weekly|Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.
11334358|NCT03528551|FG001|Participant Flow|N8-GP, Twice Weekly|Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
11334359|NCT03528551|FG002|Participant Flow|N8-GP, Three Times Weekly|Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
11334360|NCT03528551|OG000|Outcome|N8-GP, Once Weekly|Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.
11334361|NCT03528551|OG001|Outcome|N8-GP, Twice Weekly|Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).
11334362|NCT03528551|OG002|Outcome|N8-GP, Three Times Weekly|Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
11334363|NCT03528551|EG000|Reported Event|N8-GP, Once Weekly|Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.
11334364|NCT03528551|EG001|Reported Event|N8-GP, Twice Weekly|Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged < 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, AE data is presented for 135 participants in this arm (i.e. 133+2 = 135).
11334365|NCT03528551|EG002|Reported Event|N8-GP, Three Times Weekly|Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, AE data is presented for 7 participants in this arm (i.e. 2+5 = 7).
11334366|NCT03528551|EG003|Reported Event|Total|Total number of participants
11334367|NCT03528577|BG000|Baseline|Overall Baseline|Summary of Demographic Data and Baseline Characteristics (Safety Population)
11334368|NCT03528577|FG000|Participant Flow|Total|"Treatment A: Zero-dose : Two different Reference Placebo inhalers and two different Test Placebo inhalers~Treatment B: 90 mcg of Reference : One Reference inhaler, one Reference Placebo inhaler, and two different Test Placebo inhalers~Treatment C: 180 mcg of Reference Two different Reference inhalers and two different Test Placebo inhalers~Treatment D: 90 mcg of Test One Test inhaler, one Test Placebo inhaler, and two different Reference Placebo inhalers"
11334369|NCT03528577|OG000|Outcome|Primary Analysis Group|"This group included all randomized subjects who:~completed at least 1 of the 4 randomized treatment periods with an evaluable PC20FEV1.~were compliant with study treatment dosing procedures.~did not use any restricted concomitant medications.~did not have any other significant protocol deviations."
11334370|NCT03528577|EG000|Reported Event|Treatment A|Zero-dose
11334371|NCT03528577|EG001|Reported Event|Treatment B|90 mcg of Reference (PROAIR® HFA)
11334372|NCT03528577|EG002|Reported Event|Treatment C|180 mcg of Reference (PROAIR® HFA)
11334373|NCT03528577|EG003|Reported Event|Treatment D|90 mcg of Test (Albuterol Sulfate HFA Inhalation Aerosol)
11334374|NCT03529162|BG000|Baseline|Suture Anchor Technique (SA)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334375|NCT03529162|BG001|Baseline|Pectoralis Major Technique (PMT)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334376|NCT03529162|BG002|Baseline|Total|Total of all reporting groups
11334377|NCT03529162|FG000|Participant Flow|Pectoralis Major Technique (PMT)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334378|NCT03529162|FG001|Participant Flow|Suture Anchor Technique (SA)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334379|NCT03529162|OG000|Outcome|Pectoralis Major Technique (PMT)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334380|NCT03529162|OG001|Outcome|Suture Anchor Technique (SA)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334381|NCT03529162|OG000|Outcome|Suture Anchor Technique (SA)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334382|NCT03529162|OG001|Outcome|Pectoralis Major Technique (PMT)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334383|NCT03529162|EG000|Reported Event|Suture Anchor Technique (SA)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334384|NCT03529162|EG001|Reported Event|Pectoralis Major Technique (PMT)|"If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.~Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques"
11334385|NCT03529461|BG000|Baseline|Control|"Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine~Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist"
11334386|NCT03529461|BG001|Baseline|Experimental|"Intervention: Non invasive positive pressure nasal mask connected once patient is sedated~NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist"
11334387|NCT03529461|BG002|Baseline|Total|Total of all reporting groups
11334388|NCT03529461|FG000|Participant Flow|Control|"Intervention: nasal cannula 6L O2 + non invasive positive pressure (NIPPV) nasal mask not connected to machine~Rescue NIPPV via nasal mask: If oxygen desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 saturation is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If oxygen saturation > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist"
11334389|NCT03529461|FG001|Participant Flow|Experimental|"Intervention: NIPP placed on patient. Positive pressure applied once patient is sedated~NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue NIPPV maneuver attempted (including adjustments in pressure) and O2 saturation is not above 90 % within 3 min of starting NIPPV, endoscope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If saturation > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase > 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist"
11334390|NCT03529461|OG000|Outcome|Control|"Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine~Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist"
11334391|NCT03529461|OG001|Outcome|Experimental|"Intervention: Non invasive positive pressure nasal mask connected once patient is sedated~NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist"
11334392|NCT03529461|OG000|Outcome|Control Participants With Oxygen Desaturation < 90%|Rescue NIPPV: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O. If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
11334393|NCT03529461|EG000|Reported Event|Control|"Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine~Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range the pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist. If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist"
11334394|NCT03529461|EG001|Reported Event|Experimental|"Intervention: Non invasive positive pressure nasal mask connected once patient is sedated~NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.~Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist"
11334395|NCT03530098|BG000|Baseline|Control (Without-AI)|Diagnosis by radiologists made according to current standard of care methods.
11334396|NCT03530098|BG001|Baseline|Experiment (With-AI)|"Diagnosis by radiologists informed by BoneAgeModel AI algorithm incorporated into normal radiologist workflows and considered as a factor in the clinical decision making process."
11334397|NCT03530098|BG002|Baseline|Total|Total of all reporting groups
10849227|NCT00295009|FG001|Participant Flow|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
11334398|NCT03530098|FG000|Participant Flow|Control (Without-AI)|Diagnosis by radiologists made according to current standard of care methods.
11334399|NCT03530098|FG001|Participant Flow|Experiment (With-AI)|"Diagnosis by radiologists informed by BoneAgeModel Artificial Intelligence (AI) algorithm incorporated into normal radiologist workflows and considered as a factor in the clinical decision making process. The radiologists' diagnosis will be considered final. BoneAgeModel takes in a hand radiograph and gender, and outputs the skeletal (bone) age."
11334400|NCT03530098|OG000|Outcome|Control (Without-AI)|Diagnosis by radiologists made according to current standard of care methods.
11334401|NCT03530098|OG001|Outcome|Experiment (With-AI)|"Diagnosis by radiologists informed by BoneAgeModel AI algorithm incorporated into normal radiologist workflows and considered as a factor in the clinical decision making process."
11334402|NCT03530098|OG001|Outcome|Experiment (Without-AI)|"Diagnosis by radiologists informed by BoneAgeModel AI algorithm incorporated into normal radiologist workflows and considered as a factor in the clinical decision making process."
11334403|NCT03530098|EG000|Reported Event|Control (Without-AI)|Diagnosis by radiologists made according to current standard of care methods.
11334404|NCT03530098|EG001|Reported Event|Experiment (With-AI)|"Diagnosis by radiologists informed by BoneAgeModel AI algorithm incorporated into normal radiologist workflows and considered as a factor in the clinical decision making process."
11334405|NCT03530345|BG000|Baseline|Neridronic Acid - Treatment Period A|Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11334406|NCT03530345|BG001|Baseline|Placebo - Treatment Period A|Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11334407|NCT03530345|BG002|Baseline|Total|Total of all reporting groups
11334408|NCT03530345|FG000|Participant Flow|Neridronic Acid - Treatment Period A/B|"Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.~Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks."
11334409|NCT03530345|FG001|Participant Flow|Placebo - Treatment Period A/B|"Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.~Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks."
11334410|NCT03530345|OG000|Outcome|Neridronic Acid - Treatment Period A|Neridronic acid 100 mg - 4 intravenous infusions within 10 Days
11334411|NCT03530345|OG001|Outcome|Placebo - Treatment Period A|Matching placebo - 4 intravenous infusions within 10 Days
11334412|NCT03530345|OG000|Outcome|Neridronic Acid - Treatment Period A|Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11334413|NCT03530345|OG001|Outcome|Placebo - Treatment Period A|Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.
11334414|NCT03530345|EG000|Reported Event|Baseline to Week 26: Placebo TPA|In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.
11334415|NCT03530345|EG001|Reported Event|Baseline to Week 26: Neridronic Acid TPA|In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
11334416|NCT03530345|EG002|Reported Event|Week 26 to Week 52: Placebo TPA|Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
11334417|NCT03530345|EG003|Reported Event|Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB|Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.
11334418|NCT03530345|EG004|Reported Event|Week 26 to Week 52: Neridronic Acid TPA|Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
11334419|NCT03530345|EG005|Reported Event|Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB|Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
11334420|NCT03530631|BG000|Baseline|Adderall Within Subjects Design|This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects.
11334421|NCT03530631|FG000|Participant Flow|Adderall Within Subjects Design|This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects.
10849675|NCT00297427|OG000|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
11334422|NCT03530631|OG000|Outcome|Adderall/Truth|"Participants will be told they are receiving Adderall and will actually be administered Adderall.~Adderall: Participants will be administered Adderall"
11334423|NCT03530631|OG001|Outcome|Placebo/Truth|"Participants will be told they are receiving placebo and will actually be administered placebo.~Placebo: Participants will be administered placebo"
11334424|NCT03530631|OG002|Outcome|Adderall/Deception|"Participants will be told they are receiving Adderall and will actually be administered placebo.~Placebo: Participants will be administered placebo"
11334425|NCT03530631|OG003|Outcome|Placebo/Deception|"Participants will be told they are receiving placebo and will actually be administered Adderall.~Adderall: Participants will be administered Adderall"
11334426|NCT03530631|EG000|Reported Event|Adderall/Truth|"Participants will be told they are receiving Adderall and will actually be administered Adderall.~Adderall: Participants will be administered Adderall"
11334427|NCT03530631|EG001|Reported Event|Placebo/Truth|"Participants will be told they are receiving placebo and will actually be administered placebo.~Placebo: Participants will be administered placebo"
11334428|NCT03530631|EG002|Reported Event|Adderall/Deception|"Participants will be told they are receiving Adderall and will actually be administered placebo.~Placebo: Participants will be administered placebo"
11334429|NCT03530631|EG003|Reported Event|Placebo/Deception|"Participants will be told they are receiving placebo and will actually be administered Adderall.~Adderall: Participants will be administered Adderall"
11334430|NCT03530917|BG000|Baseline|Single Ascending Dose (SAD): Placebo|In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
11334431|NCT03530917|BG001|Baseline|SAD: Cohort 1|Eight participants will be administered 40mg RO7020531 orally on Day 1.
11334432|NCT03530917|BG002|Baseline|SAD: Cohort 2|Eight participants will be administered 100mg RO7020531 orally on Day 1.
11334433|NCT03530917|BG003|Baseline|SAD: Cohort 3|Eight participants will be administered 140mg RO7020531 orally on Day 1.
11334434|NCT03530917|BG004|Baseline|SAD: Cohort 4|Eight participants will be administered 170mg RO7020531 orally on Day 1.
11334435|NCT03530917|BG005|Baseline|Multiple Ascending Dose (MAD): Placebo|In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
11334436|NCT03530917|BG006|Baseline|MAD: Cohort 1|Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334437|NCT03530917|BG007|Baseline|MAD: Cohorts 2 and 3|Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334438|NCT03530917|BG008|Baseline|Total|Total of all reporting groups
11334439|NCT03530917|FG000|Participant Flow|Single Ascending Dose (SAD): Placebo|In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
11334440|NCT03530917|FG001|Participant Flow|SAD: Cohort 1|Eight participants will be administered 40mg RO7020531 orally on Day 1.
11334441|NCT03530917|FG002|Participant Flow|SAD: Cohort 2|Eight participants will be administered 100mg RO7020531 orally on Day 1.
11334442|NCT03530917|FG003|Participant Flow|SAD: Cohort 3|Eight participants will be administered 140mg RO7020531 orally on Day 1.
11334443|NCT03530917|FG004|Participant Flow|SAD: Cohort 4|Eight participants will be administered 170mg RO7020531 orally on Day 1.
11334444|NCT03530917|FG005|Participant Flow|Multiple Ascending Dose (MAD): Placebo|In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
11334445|NCT03530917|FG006|Participant Flow|MAD: Cohort 1|Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334446|NCT03530917|FG007|Participant Flow|MAD: Cohorts 2 and 3|Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334447|NCT03530917|OG000|Outcome|Single Ascending Dose (SAD): Placebo|In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
11334448|NCT03530917|OG001|Outcome|SAD: Cohort 1|Eight participants will be administered 40mg RO7020531 orally on Day 1.
11334449|NCT03530917|OG002|Outcome|SAD: Cohort 2|Eight participants will be administered 100mg RO7020531 orally on Day 1.
11334450|NCT03530917|OG003|Outcome|SAD: Cohort 3|Eight participants will be administered 140mg RO7020531 orally on Day 1.
11334451|NCT03530917|OG004|Outcome|SAD: Cohort 4|Eight participants will be administered 170mg RO7020531 orally on Day 1.
11334452|NCT03530917|OG005|Outcome|Multiple Ascending Dose (MAD): Placebo|In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
11334453|NCT03530917|OG006|Outcome|MAD: Cohort 1|Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334454|NCT03530917|OG007|Outcome|MAD: Cohorts 2 and 3|Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334455|NCT03530917|OG000|Outcome|SAD: Cohort 1|Eight participants will be administered 40mg RO7020531 orally on Day 1.
11334456|NCT03530917|OG001|Outcome|SAD: Cohort 2|Eight participants will be administered 100mg RO7020531 orally on Day 1.
11334457|NCT03530917|OG002|Outcome|SAD: Cohort 3|Eight participants will be administered 140mg RO7020531 orally on Day 1.
11334458|NCT03530917|OG003|Outcome|SAD: Cohort 4|Eight participants will be administered 170mg RO7020531 orally on Day 1.
11334459|NCT03530917|OG004|Outcome|MAD: Cohort 1|Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334460|NCT03530917|OG005|Outcome|MAD: Cohorts 2 and 3|Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334461|NCT03530917|EG000|Reported Event|Single Ascending Dose (SAD): Placebo|In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
11334462|NCT03530917|EG001|Reported Event|SAD: Cohort 1|Eight participants will be administered 40mg RO7020531 orally on Day 1.
11334463|NCT03530917|EG002|Reported Event|SAD: Cohort 2|Eight participants will be administered 100mg RO7020531 orally on Day 1.
11334464|NCT03530917|EG003|Reported Event|SAD: Cohort 3|Eight participants will be administered 140mg RO7020531 orally on Day 1.
11334465|NCT03530917|EG004|Reported Event|SAD: Cohort 4|Eight participants will be administered 170mg RO7020531 orally on Day 1.
11334466|NCT03530917|EG005|Reported Event|Multiple Ascending Dose (MAD): Placebo|In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
11334467|NCT03530917|EG006|Reported Event|MAD: Cohort 1|Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334468|NCT03530917|EG007|Reported Event|MAD: Cohorts 2 and 3|Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
11334469|NCT03531710|BG000|Baseline|M7E1|Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334470|NCT03531710|BG001|Baseline|M7E3|Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334471|NCT03531710|BG002|Baseline|M5E1|Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334472|NCT03531710|BG003|Baseline|M5E3|Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334473|NCT03531710|BG004|Baseline|M0E1|Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334474|NCT03531710|BG005|Baseline|M0E3|Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334475|NCT03531710|BG006|Baseline|Total|Total of all reporting groups
11334476|NCT03531710|FG000|Participant Flow|M7E1|Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334477|NCT03531710|FG001|Participant Flow|M7E3|Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334478|NCT03531710|FG002|Participant Flow|M5E1|Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334479|NCT03531710|FG003|Participant Flow|M5E3|Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334480|NCT03531710|FG004|Participant Flow|M0E1|Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334481|NCT03531710|FG005|Participant Flow|M0E3|Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334482|NCT03531710|OG000|Outcome|M7E1|Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334483|NCT03531710|OG001|Outcome|M7E3|Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334484|NCT03531710|OG002|Outcome|M5E1|Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334485|NCT03531710|OG003|Outcome|M5E3|Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334486|NCT03531710|OG004|Outcome|M0E1|Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334487|NCT03531710|OG005|Outcome|M0E3|Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334488|NCT03531710|EG000|Reported Event|M7E1|Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334489|NCT03531710|EG001|Reported Event|M7E3|Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334490|NCT03531710|EG002|Reported Event|M5E1|Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334491|NCT03531710|EG003|Reported Event|M5E3|Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334492|NCT03531710|EG004|Reported Event|M0E1|Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)
11334493|NCT03531710|EG005|Reported Event|M0E3|Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
11334494|NCT03531840|BG000|Baseline|Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes|Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
11334495|NCT03531840|BG001|Baseline|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334496|NCT03531840|BG002|Baseline|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With no tumor tissue available for somatic mutation
10849676|NCT00297427|OG000|Outcome|Acupuncture|Ture acupuncture twice a week for 6 weeks
11334497|NCT03531840|BG003|Baseline|Participants Not Classified Under Comparison Groups|Participants With no tumor tissue available for somatic mutation
11334498|NCT03531840|BG004|Baseline|Total|Total of all reporting groups
11334499|NCT03531840|FG000|Participant Flow|Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes|Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
11334500|NCT03531840|FG001|Participant Flow|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334501|NCT03531840|FG002|Participant Flow|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
11334502|NCT03531840|FG003|Participant Flow|Participants Not Classified Under Comparison Groups|Participants With no tumor tissue available for somatic mutation
11334503|NCT03531840|OG000|Outcome|Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes|Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
11334504|NCT03531840|OG001|Outcome|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334505|NCT03531840|OG002|Outcome|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
11334506|NCT03531840|OG003|Outcome|Participants Not Classified Under Comparison Groups|Participants with no tumor tissue available for somatic mutation
11334507|NCT03531840|OG000|Outcome|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334508|NCT03531840|OG000|Outcome|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With no tumor tissue available for somatic mutation
11334509|NCT03531840|OG001|Outcome|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Comparison Group 2 Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334510|NCT03531840|OG002|Outcome|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With no tumor tissue available for somatic mutation
11334511|NCT03531840|OG003|Outcome|Participants Not Classified Under Comparison Groups|Participants With no tumor tissue available for somatic mutation
11334512|NCT03531840|EG000|Reported Event|Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes|Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
11334513|NCT03531840|EG001|Reported Event|Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations|Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
11334514|NCT03531840|EG002|Reported Event|Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations|Participants With no tumor tissue available for somatic mutation
11334515|NCT03531840|EG003|Reported Event|Participants Not Classified Under Comparison Groups|Participants With no tumor tissue available for somatic mutation
11334516|NCT03531905|BG000|Baseline|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11334517|NCT03531905|BG001|Baseline|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11334518|NCT03531905|BG002|Baseline|Placebo|Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.
11334519|NCT03531905|BG003|Baseline|Total|Total of all reporting groups
11334520|NCT03531905|FG000|Participant Flow|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11334521|NCT03531905|FG001|Participant Flow|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11334522|NCT03531905|FG002|Participant Flow|Placebo|Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.
11334523|NCT03531905|OG000|Outcome|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11334524|NCT03531905|OG001|Outcome|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11334525|NCT03531905|OG002|Outcome|Placebo|Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.
11334526|NCT03531905|OG000|Outcome|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11334527|NCT03531905|OG001|Outcome|Placebo|Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.
11334528|NCT03531905|EG000|Reported Event|Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC|Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.
11334529|NCT03531905|EG001|Reported Event|Ezetimibe 10 mg|Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.
11334530|NCT03531905|EG002|Reported Event|Placebo|Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks.
11334531|NCT03532009|BG000|Baseline|Sodium Zirconium Cyclosilicate|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received SZC 10 g orally tid for 2 days followed by SZC 5 g qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received SZC 5 g orally qd for 3 months.~SZC was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334532|NCT03532009|BG001|Baseline|Placebo|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received placebo orally tid for 2 days followed by placebo qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received placebo orally qd for 3 months.~Placebo was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334533|NCT03532009|BG002|Baseline|Total|Total of all reporting groups
11334534|NCT03532009|FG000|Participant Flow|Sodium Zirconium Cyclosilicate|"Patients with serum potassium (S-K) concentration > 5.0 millimole/litre (mmol/L) at the last assessment before randomisation received SZC 10 grams (g) orally 3 times daily (tid) for 2 days followed by SZC 5 g once daily (qd) for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received SZC 5 g orally qd for 3 months.~SZC was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334535|NCT03532009|FG001|Participant Flow|Placebo|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received placebo orally tid for 2 days followed by placebo qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received placebo orally qd for 3 months.~Placebo was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334536|NCT03532009|OG000|Outcome|Sodium Zirconium Cyclosilicate|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received SZC 10 g orally tid for 2 days followed by SZC 5 g qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received SZC 5 g orally qd for 3 months.~SZC was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334537|NCT03532009|OG001|Outcome|Placebo|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received placebo orally tid for 2 days followed by placebo qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received placebo orally qd for 3 months.~Placebo was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334538|NCT03532009|EG000|Reported Event|Sodium Zirconium Cyclosilicate|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received SZC 10 g orally tid for 2 days followed by SZC 5 g qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received SZC 5 g orally qd for 3 months.~SZC was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11334539|NCT03532009|EG001|Reported Event|Placebo|"Patients with S-K concentration > 5.0 mmol/L at the last assessment before randomisation received placebo orally tid for 2 days followed by placebo qd for 3 months.~Patients with S-K concentration ≤ 5.0 mmol/L at the last assessment before randomisation received placebo orally qd for 3 months.~Placebo was up- or down- titrated depending on local laboratory S-K concentration at every study visit."
11335393|NCT03549429|FG001|Participant Flow|TegadermTM on L Eye, EyeGard® on R Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11335394|NCT03549429|OG000|Outcome|Erythema With TegadermTM Only|TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid.
11336593|NCT03569033|OG001|Outcome|Placebo BID|Participants received a matching placebo tablet BID for 7 days.
11334540|NCT03532048|BG000|Baseline|Intervention Group|"The Papás Saludables, Niños Saludables Program~The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions."
11334541|NCT03532048|BG001|Baseline|Wait-list Control|"The Papás Saludables, Niños Saludables Wait-list Control~The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected."
11334542|NCT03532048|BG002|Baseline|Total|Total of all reporting groups
11334543|NCT03532048|FG000|Participant Flow|Intervention Group|"The Papás Saludables, Niños Saludables Program~The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions."
11334544|NCT03532048|FG001|Participant Flow|Wait-list Control|"The Papás Saludables, Niños Saludables Wait-list Control~The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected."
11334545|NCT03532048|OG000|Outcome|Intervention Group|"The Papás Saludables, Niños Saludables Program~The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions."
11334546|NCT03532048|OG001|Outcome|Wait-list Control|"The Papás Saludables, Niños Saludables Wait-list Control~The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected."
11334547|NCT03532048|EG000|Reported Event|Intervention Group|"The Papás Saludables, Niños Saludables Program~The Papás Saludables, Niños Saludables Program: Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions."
11334548|NCT03532048|EG001|Reported Event|Wait-list Control|"The Papás Saludables, Niños Saludables Wait-list Control~The Papás Saludables, Niños Saludables Wait-list Control: The same program as above delivered to the wait-list control after the T1 follow-up data has been collected."
11334549|NCT03532308|BG000|Baseline|Intervention|"Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Fermented Soy: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks."
11334550|NCT03532308|BG001|Baseline|Placebo|"Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used."
11334551|NCT03532308|BG002|Baseline|Total|Total of all reporting groups
11334552|NCT03532308|FG000|Participant Flow|Intervention|"Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Fermented Soy: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks."
11334553|NCT03532308|FG001|Participant Flow|Placebo|"Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used."
11334554|NCT03532308|OG000|Outcome|Intervention|"Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Fermented Soy: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks."
11334555|NCT03532308|OG001|Outcome|Placebo|"Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used."
11334556|NCT03532308|EG000|Reported Event|Intervention|"Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Fermented Soy: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks."
11334557|NCT03532308|EG001|Reported Event|Placebo|"Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.~Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used."
11334558|NCT03532776|BG000|Baseline|Podofilox Gel 0.5 %|"Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles~Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334559|NCT03532776|BG001|Baseline|Condylox Topical Gel 0.5%|"Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles~Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334560|NCT03532776|BG002|Baseline|Placebo Gel|"Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient~Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334561|NCT03532776|BG003|Baseline|Total|Total of all reporting groups
11334562|NCT03532776|FG000|Participant Flow|Podofilox Gel 0.5 %|"Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles~Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334563|NCT03532776|FG001|Participant Flow|Condylox Topical Gel 0.5%|"Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles~Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334564|NCT03532776|FG002|Participant Flow|Placebo Gel|"Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient~Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334565|NCT03532776|OG000|Outcome|Podofilox Gel 0.5 %|"Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles~Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334566|NCT03532776|OG001|Outcome|Condylox Topical Gel 0.5%|"Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles~Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334567|NCT03532776|OG002|Outcome|Placebo Gel|Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
11334568|NCT03532776|OG002|Outcome|Placebo Gel|"Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient~Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334569|NCT03532776|EG000|Reported Event|Podofilox Gel 0.5 %|"Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles~Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334570|NCT03532776|EG001|Reported Event|Condylox Topical Gel 0.5%|"Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles~Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334571|NCT03532776|EG002|Reported Event|Placebo Gel|"Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient~Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles"
11334572|NCT03533036|BG000|Baseline|Virtual Reality Intervention|Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.
11334573|NCT03533036|BG001|Baseline|Control Arm|In the control group, participants did not use virtual reality during the procedure.
11334574|NCT03533036|BG002|Baseline|Total|Total of all reporting groups
11335501|NCT03551743|FG002|Participant Flow|Module 4 (800 mg Bolus + 480 mg Infusion)|800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
11334575|NCT03533036|FG000|Participant Flow|Virtual Reality Intervention|Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.
11334576|NCT03533036|FG001|Participant Flow|Control Arm|In the control group, participants did not use virtual reality during the procedure.
11334577|NCT03533036|OG000|Outcome|Virtual Reality Intervention|Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.
11334578|NCT03533036|OG001|Outcome|Control Arm|In the control group, participants did not use virtual reality during the procedure.
11334579|NCT03533036|EG000|Reported Event|Virtual Reality Intervention|Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.
11334580|NCT03533036|EG001|Reported Event|Control Arm|In the control group, participants did not use virtual reality during the procedure.
11334581|NCT03533114|BG000|Baseline|On Baseline IH Medication|Participants treated with medication for IH at baseline.
11334582|NCT03533114|BG001|Baseline|Treatment Naïve|Participants not treated with medication for IH at baseline.
11334583|NCT03533114|BG002|Baseline|Total|Total of all reporting groups
11334584|NCT03533114|FG000|Participant Flow|On Baseline IH Medication|Participants treated with medication for IH at baseline.
11334585|NCT03533114|FG001|Participant Flow|Treatment Naive|Participants not treated with medication for IH at baseline.
11334586|NCT03533114|OG000|Outcome|JZP-258|Participants randomized to JZP-258 will receive the dosing regimen taken during the Stable Dose Period.
11334587|NCT03533114|OG001|Outcome|Placebo|Participants randomized to placebo will receive an oral solution equivalent to the dosing regimen of JZP-258 taken during the Stable Dose Period.
11334588|NCT03533114|EG000|Reported Event|On Baseline IH Medication|Participants treated with medication for IH at baseline.
11334589|NCT03533114|EG001|Reported Event|Treatment Naive|Participants not treated with medication for IH at baseline.
11334590|NCT03533114|EG002|Reported Event|JZP-058|Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period at the stable dose and regimen for 2 weeks.
11334591|NCT03533114|EG003|Reported Event|Placebo|Participants randomized to placebo were administered placebo oral solution at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks.
11334592|NCT03533244|BG000|Baseline|Vehicle Eye Drops|"One drop, three times daily to the study eye for 28 days~Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days"
11334593|NCT03533244|BG001|Baseline|0.1% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334594|NCT03533244|BG002|Baseline|0.3% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334595|NCT03533244|BG003|Baseline|Total|Total of all reporting groups
11334596|NCT03533244|FG000|Participant Flow|Vehicle Eye Drops|"One drop, three times daily to the study eye for 28 days~Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days"
11334597|NCT03533244|FG001|Participant Flow|0.1% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334598|NCT03533244|FG002|Participant Flow|0.3% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334599|NCT03533244|OG000|Outcome|Vehicle Eye Drops|"One drop, three times daily to the study eye for 28 days~Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days"
11334600|NCT03533244|OG001|Outcome|0.1% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334601|NCT03533244|OG002|Outcome|0.3% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334602|NCT03533244|EG000|Reported Event|Vehicle Eye Drops|"One drop, three times daily to the study eye for 28 days~Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days"
11334603|NCT03533244|EG001|Reported Event|0.1% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334604|NCT03533244|EG002|Reported Event|0.3% AG-86893 Eye Drops|"One drop, three times daily to the study eye for 28 days~0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days"
11334605|NCT03533374|BG000|Baseline|Patients With Epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334606|NCT03533374|BG001|Baseline|Patients With Non-epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334607|NCT03533374|BG002|Baseline|Total|Total of all reporting groups
11335395|NCT03549429|OG001|Outcome|Erythema With EyeGard® Only|TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid.
11334608|NCT03533374|FG000|Participant Flow|Patients With Epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334609|NCT03533374|FG001|Participant Flow|Patients With Non-epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334610|NCT03533374|OG000|Outcome|Patients With Epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334611|NCT03533374|OG001|Outcome|Patients With Non-epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334612|NCT03533374|EG000|Reported Event|Patients With Epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334613|NCT03533374|EG001|Reported Event|Patients With Non-epileptic Seizures|"Electroencephalogram (EEG) and visual evaluation~- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).~Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians)."
11334614|NCT03533608|BG000|Baseline|Group PE|Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
11334615|NCT03533608|FG000|Participant Flow|Group PE|Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
11334616|NCT03533608|OG000|Outcome|Group PE|"Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.~Group PE: Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms."
11334617|NCT03533608|OG000|Outcome|Group PE|Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
11334618|NCT03533608|EG000|Reported Event|Group PE|Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
11334619|NCT03533829|BG000|Baseline|Buzzy®|"Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination."
11334620|NCT03533829|BG001|Baseline|Music|"Music will be selected and listened to as a distraction before and during vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334621|NCT03533829|BG002|Baseline|Buzzy® and Music|"Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334622|NCT03533829|BG003|Baseline|Total|Total of all reporting groups
11334623|NCT03533829|FG000|Participant Flow|Buzzy®|"Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination."
11334624|NCT03533829|FG001|Participant Flow|Music|"Music will be selected and listened to as a distraction before and during vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334625|NCT03533829|FG002|Participant Flow|Buzzy® and Music|"Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334626|NCT03533829|OG000|Outcome|Buzzy®|"Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination."
11334627|NCT03533829|OG001|Outcome|Music|"Music will be selected and listened to as a distraction before and during vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334628|NCT03533829|OG002|Outcome|Buzzy® and Music|"Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334629|NCT03533829|EG000|Reported Event|Buzzy®|"Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination."
11334630|NCT03533829|EG001|Reported Event|Music|"Music will be selected and listened to as a distraction before and during vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334631|NCT03533829|EG002|Reported Event|Buzzy® and Music|"Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.~Buzzy®: Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.~Music: Music will be selected and listened to as a distraction before and during vaccination."
11334632|NCT03534427|BG000|Baseline|Control Group|No exercise intervention
11334633|NCT03534427|BG001|Baseline|Jump Rope Exercise Intervention|"The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.~Jump rope exercise intervention: 12-week jump rope exercise program"
11334634|NCT03534427|BG002|Baseline|Total|Total of all reporting groups
11334635|NCT03534427|FG000|Participant Flow|Control Group|No exercise intervention
11334636|NCT03534427|FG001|Participant Flow|Jump Rope Exercise Intervention|"The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.~Jump rope exercise intervention: 12-week jump rope exercise program"
11334637|NCT03534427|OG000|Outcome|Control Group|No exercise intervention
11334638|NCT03534427|OG001|Outcome|Jump Rope Exercise Intervention|"The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.~Jump rope exercise intervention: 12-week jump rope exercise program"
11334639|NCT03534427|EG000|Reported Event|Control Group|No exercise intervention
11334640|NCT03534427|EG001|Reported Event|Jump Rope Exercise Intervention|"The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.~Jump rope exercise intervention: 12-week jump rope exercise program"
11334641|NCT03534986|BG000|Baseline|AffloVest The Vest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Hill-Rom The Vest: High-frequency chest wall oscillation vest"
11334642|NCT03534986|BG001|Baseline|AffloVest inCourage Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Respirtech inCourage: High-frequency chest wall oscillation vest"
11334643|NCT03534986|BG002|Baseline|AffloVest SmartVest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Electromed SmartVest: High-frequency chest wall oscillation vest"
11334644|NCT03534986|BG003|Baseline|Total|Total of all reporting groups
11334645|NCT03534986|FG000|Participant Flow|AffloVest The Vest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Hill-Rom The Vest: High-frequency chest wall oscillation vest"
11334646|NCT03534986|FG001|Participant Flow|AffloVest inCourage Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Respirtech inCourage: High-frequency chest wall oscillation vest"
11334647|NCT03534986|FG002|Participant Flow|AffloVest SmartVest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Electromed SmartVest: High-frequency chest wall oscillation vest"
11334648|NCT03534986|OG000|Outcome|Baseline|Patient Baseline Results
11334649|NCT03534986|OG001|Outcome|AffloVest Arm|"Devices placed on highest intensity / highest frequency~Hill-Rom The Vest: High-frequency chest wall oscillation vest"
11334650|NCT03534986|OG002|Outcome|Compressor Arm|"Devices placed on highest intensity / highest frequency~Compressor-type device"
11334651|NCT03534986|EG000|Reported Event|AffloVest The Vest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Hill-Rom The Vest: High-frequency chest wall oscillation vest"
11334652|NCT03534986|EG001|Reported Event|AffloVest inCourage Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Respirtech inCourage: High-frequency chest wall oscillation vest"
11334653|NCT03534986|EG002|Reported Event|AffloVest SmartVest Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Electromed SmartVest: High-frequency chest wall oscillation vest"
11334654|NCT03535194|BG000|Baseline|Mirikizumab 250mg Q4W/250mg Q8W|"Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period.~Participants received placebo at weeks 1, 2, 3 to match Secukinumab. Participants received matching placebo to blind Secukinumab."
11334655|NCT03535194|BG001|Baseline|250mg Mirikizumab /125mg Q8W|"Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period.~Participants received matching placebo to blind Secukinumab."
11334656|NCT03535194|BG002|Baseline|Placebo/250mg Mirikizumab|Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
11334657|NCT03535194|BG003|Baseline|300mg Secukinumab|Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
11334658|NCT03535194|BG004|Baseline|Japan GPP/EP|Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
11334659|NCT03535194|BG005|Baseline|Total|Total of all reporting groups
11334660|NCT03535194|FG000|Participant Flow|250mg Q4W/250mg Q8W Mirikizumab|"Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W).~Participants received matching placebo to blind Secukinumab."
11334661|NCT03535194|FG001|Participant Flow|250mg Q4W/125mg Q8W Mirikizumab|"Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period.~Participants received matching placebo to blind Secukinumab."
11334662|NCT03535194|FG002|Participant Flow|Placebo/250mg Mirikizumab|Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
11334663|NCT03535194|FG003|Participant Flow|300mg Secukinumab|Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
11334664|NCT03535194|FG004|Participant Flow|Japan GPP/EP|Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
11334665|NCT03535194|OG000|Outcome|Placebo|Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.
11334666|NCT03535194|OG001|Outcome|300mg Secukinumab|Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.
11334667|NCT03535194|OG002|Outcome|250mg Q4W Mirikizumab|Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
11334668|NCT03535194|OG000|Outcome|Mirikizumab 250mg Q4W|Participants received 250mg Mirikizumab once every four weeks by subcutaneous injection.
11334669|NCT03535194|EG000|Reported Event|Placebo / Induction Period|Participants received matching placebo by subcutaneous injection in induction period.
11334670|NCT03535194|EG001|Reported Event|300mg Secukinumab / Induction Period|Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.
11334671|NCT03535194|EG002|Reported Event|250mg Mirikizumab Q4W / Induction Period|Participants received 250 Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period.
11334672|NCT03535194|EG003|Reported Event|250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period|Participants received 250mg Mirikizumab Q4Wby subcutaneous injection in induction period.
11334673|NCT03535194|EG004|Reported Event|300mg Secukinumab/Maintenance Period|Participants received 300mg Secukinumab Q4W by subcutaneous injection from week 16 to 52 in maintenance period.
11334674|NCT03535194|EG005|Reported Event|125mg Mirikizumab Q8W / Maintenance Period|Participants received 125mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period.
11334675|NCT03535194|EG006|Reported Event|250mg Mirikizumab Q8W / Maintenance Period|Participants received 250mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period.
11334676|NCT03535194|EG007|Reported Event|250mg Mirikizumab / Maintenance Period|Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 by subcutaneous injection in maintenance period.
11334677|NCT03535194|EG008|Reported Event|250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period|Participants received 250mg Q8W by subcutaneous injection in maintenance period
11334678|NCT03535194|EG009|Reported Event|Placebo / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period.
11334679|NCT03535194|EG010|Reported Event|300mg Secukinumab / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334680|NCT03535194|EG011|Reported Event|250mg Mirikizumab Q4W / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334681|NCT03535194|EG012|Reported Event|250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
10843347|NCT00253747|OG001|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843348|NCT00253747|OG002|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Week 11|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843349|NCT00253747|OG003|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843350|NCT00253747|OG004|Outcome|Release Methylphenidate (OROS-MPH)-Week 4|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843351|NCT00253747|OG005|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843352|NCT00253747|OG006|Outcome|Release Methylphenidate (OROS-MPH)-Week 7|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843353|NCT00253747|OG007|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843354|NCT00253747|OG008|Outcome|Release Methylphenidate (OROS-MPH)-Week 9|OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843355|NCT00253747|OG009|Outcome|Methylphenidate (OROS-MPH) - Placebo-Week 9|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843356|NCT00253747|EG000|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843357|NCT00253747|EG001|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
10843358|NCT00253890|BG000|Baseline|Trazodone|50-150mg at bedtime
10843359|NCT00253890|BG001|Baseline|Placebo|1-3 at bedtime
10843360|NCT00253890|BG002|Baseline|Total|Total of all reporting groups
10843361|NCT00253890|FG000|Participant Flow|Trazodone|50-150mg at bedtime
10843362|NCT00253890|FG001|Participant Flow|Placebo|1-3 capsules at bedtime
10843363|NCT00253890|OG000|Outcome|Trazodone|50-150mg at bedtime
10843364|NCT00253890|OG001|Outcome|Placebo|1-3 capsules at bedtime
10843365|NCT00253890|EG000|Reported Event|Trazodone|50-150mg at bedtime
10843366|NCT00253890|EG001|Reported Event|Placebo|1-3 at bedtime
10843367|NCT00254072|BG000|Baseline|Smaller Stapler|3.5 mm Circular Stapler
10843368|NCT00254072|BG001|Baseline|Larger Stapler|4.8 mm Circular Stapler
10843369|NCT00254072|BG002|Baseline|Total|Total of all reporting groups
10843370|NCT00254072|FG000|Participant Flow|Smaller Stapler|3.5 mm Circular Stapler
10843371|NCT00254072|FG001|Participant Flow|Larger Stapler|4.8 mm Circular Stapler
10843372|NCT00254072|OG000|Outcome|Smaller Stapler|3.5 mm Circular Stapler
10843373|NCT00254072|OG001|Outcome|Larger Stapler|4.8 mm Circular Stapler
10843374|NCT00254072|EG000|Reported Event|Smaller Stapler|3.5 mm Circular Stapler
10843375|NCT00254072|EG001|Reported Event|Larger Stapler|4.8 mm Circular Stapler
10843376|NCT00254163|BG000|Baseline|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
10843377|NCT00254163|BG001|Baseline|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
10843378|NCT00254163|BG002|Baseline|Total|Total of all reporting groups
10843379|NCT00254163|FG000|Participant Flow|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
10843380|NCT00254163|FG001|Participant Flow|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
10843381|NCT00254163|OG000|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
10843382|NCT00254163|OG001|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
10843383|NCT00254163|EG000|Reported Event|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
10843384|NCT00254163|EG001|Reported Event|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
10843385|NCT00254293|BG000|Baseline|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10846530|NCT00277394|FG001|Participant Flow|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
11334682|NCT03535194|EG013|Reported Event|250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334683|NCT03535194|EG014|Reported Event|250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334684|NCT03535194|EG015|Reported Event|Placebo/250mg Mirikizumab / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334685|NCT03535194|EG016|Reported Event|250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334686|NCT03535194|EG017|Reported Event|300mg Secukinumab /300mg Secukinumab / Follow-up Period|Participants did not receive any intervention in post- treatment follow-up period
11334687|NCT03535571|BG000|Baseline|Salmon Protein Hydrolysate (CollaGo)|"Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334688|NCT03535571|FG000|Participant Flow|Salmon Protein Hydrolysate (CollaGo)|"Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334689|NCT03535571|OG000|Outcome|Salmon Protein Hydrolysate (CollaGo®)|"Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334690|NCT03535571|OG000|Outcome|Salmon Protein Hydrolysate (CollaGo)|"Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334691|NCT03535571|OG000|Outcome|Salmon Protein Hydrolysate (CollaGo)|"Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334692|NCT03535571|EG000|Reported Event|Salmon Protein Hydrolysate (CollaGo)|"Dose: 1 sachet of CollaGo will be mixed with 100-300 mL of water and consumed daily at breakfast.~Salmon Protein Hydrolysate: 4g of salmon protein hydrolysate per serving."
11334693|NCT03535649|BG000|Baseline|Vedolizumab|Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
11334694|NCT03535649|FG000|Participant Flow|Vedolizumab|Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
11334695|NCT03535649|OG000|Outcome|Vedolizumab|Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
11334696|NCT03535649|EG000|Reported Event|Vedolizumab|Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
11334697|NCT03535844|BG000|Baseline|Wolfberry With Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.~Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334698|NCT03535844|BG001|Baseline|Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334699|NCT03535844|BG002|Baseline|Total|Total of all reporting groups
11334700|NCT03535844|FG000|Participant Flow|Wolfberry With Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.~Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334701|NCT03535844|FG001|Participant Flow|Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334702|NCT03535844|OG000|Outcome|Wolfberry With Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.~Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334703|NCT03535844|OG001|Outcome|Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334704|NCT03535844|EG000|Reported Event|Wolfberry With Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.~Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334705|NCT03535844|EG001|Reported Event|Healthy Diet|"Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.~Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board."
11334706|NCT03535974|BG000|Baseline|AI-P Sequence (12)|Participants who received AI initially (first six weeks, V1 and V2) and P afterwards
11334707|NCT03535974|BG001|Baseline|P-AI Sequence (17)|Participants who received placebo (P) initially (first six weeks, V1 and V2) and AI afterwards
11334708|NCT03535974|BG002|Baseline|AI-AI Sequence (5)|Participants who received AI initially (first six weeks, V1 and V2) and AI afterwards
11334709|NCT03535974|BG003|Baseline|Total|Total of all reporting groups
11334710|NCT03535974|FG000|Participant Flow|Sequence AI-P: Active Ingredient (Spirulina) Then Placebo|Patients in this sequence first received 6 weeks the Active Ingredient (Spirulina) bid, and afterwards 6 weeks Placebo bid
11334711|NCT03535974|FG001|Participant Flow|Sequence P-AI: Placebo Then Active Ingredient (Spirulina)|Placebo administration for 6 weeks bid; afterwards Active Ingredient (Spirulina) for 6 weeks bid
11334712|NCT03535974|FG002|Participant Flow|Sequence AI-AI (Active Ingredient, Then Active Ingredient)|Patients receive Active Ingredient (AI) for 6 weeks bid, and afterwards Active Ingredient (AI) for 6 weeks bid
11334713|NCT03535974|OG000|Outcome|Preparation With Spirulina|"6 weeks bid Preparation with Spirulina~Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules decrease of 19.88% (mean) +/- 15.55 (SD)"
11334714|NCT03535974|OG001|Outcome|Placebo|"6 weeks bid Placebo~Placebo: Placebo administration for 6 weeks bid decrease of 9.21% (mean) +/- 14.29 (SD)"
11334715|NCT03535974|OG000|Outcome|All AI Administrations (n=39)|Number of all 6 weeks administrations of AI in all 34 patients and all sequences (AI-P, AI-AI, and P-AI)
11334716|NCT03535974|OG001|Outcome|All P Administrations (n=29)|Number of all 6 weeks administrations of P in all 34 patients and all sequences (AI-P and P-AI)
11334717|NCT03535974|EG000|Reported Event|Preparation With Spirulina|"6 weeks bid Preparation with Spirulina~Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules~0 adverse reactions"
11334718|NCT03535974|EG001|Reported Event|Placebo|"6 weeks bid Placebo~Placebo: Placebo administration for 6 weeks bid~One patient had a severe allergic reaction while she was on placebo and multiple other medications and withdrew from the study"
11334719|NCT03536663|BG000|Baseline|Endexo|"Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 13 weeks.~Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 13 weeks."
11334720|NCT03536663|FG000|Participant Flow|Optiflux/Endexo|"Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks.~Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks."
11334721|NCT03536663|OG000|Outcome|Endexo|"Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.~Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks."
11334722|NCT03536663|OG000|Outcome|Optiflux|Optiflux dialyzer: Hemodialysis treatments on the optiflux dialyzer starts at visit 1 and continues until visit 12.
11334723|NCT03536663|OG001|Outcome|Endexo|Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
11334724|NCT03536663|OG000|Outcome|Optiflux|Optiflux d: Hemodialysis treatments on the dialyzer with Endexo starts at visit 1 and continues until visit 12.
11334725|NCT03536663|OG000|Outcome|Optiflux|Optiflux dialyzer: Hemodialysis treatments on the dialyzer with Endexo starts at visit 1 and continues until visit 12.
11334726|NCT03536663|EG000|Reported Event|Optiflux|Hemodialysis treatments on Optiflux dialyzer starts at visit 1 and continues for 4 weeks to visit 12. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.
11334727|NCT03536663|EG001|Reported Event|Endexo|Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.
11334728|NCT03536702|BG000|Baseline|Creative Writing Workshop|"The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.~Creative Writing Workshop: This group will participate in a writing workshop in group sessions."
11334729|NCT03536702|BG001|Baseline|Independent Writing - Control Group|"The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.~Independent Writing - Control Group: This group will receive a book for a self writing session."
11334730|NCT03536702|BG002|Baseline|Total|Total of all reporting groups
11334731|NCT03536702|FG000|Participant Flow|Creative Writing Workshop|"The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.~Creative Writing Workshop: This group will participate in a writing workshop in group sessions."
11334732|NCT03536702|FG001|Participant Flow|Independent Writing - Control Group|"The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.~Independent Writing - Control Group: This group will receive a book for a self writing session."
11334733|NCT03536702|OG000|Outcome|Creative Writing Workshop|"The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.~Creative Writing Workshop: This group will participate in a writing workshop in group sessions."
11334734|NCT03536702|OG001|Outcome|Independent Writing - Control Group|"The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.~Independent Writing - Control Group: This group will receive a book for a self writing session."
11334735|NCT03536702|EG000|Reported Event|Creative Writing Workshop|"The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.~Creative Writing Workshop: This group will participate in a writing workshop in group sessions."
11334736|NCT03536702|EG001|Reported Event|Independent Writing - Control Group|"The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.~Independent Writing - Control Group: This group will receive a book for a self writing session."
11334737|NCT03536819|BG000|Baseline|Treatment|"Participants receive Votiva treatment~Votiva: The applicator uses radio-frequency energy to treat the vaginal canal"
11334738|NCT03536819|FG000|Participant Flow|Treatment|"Participants receive Votiva treatment~Votiva: The applicator uses radio-frequency energy to treat the vaginal canal"
11334739|NCT03536819|OG000|Outcome|Treatment|"Participants receive Votiva treatment~Votiva: The applicator uses radio-frequency energy to treat the vaginal canal"
11334740|NCT03536819|EG000|Reported Event|Treatment|"Participants receive Votiva treatment~Votiva: The applicator uses radio-frequency energy to treat the vaginal canal"
11334741|NCT03536923|BG000|Baseline|Leva Arm|"Subjects will use the leva device twice daily to perform pelvic floor muscle exercises~Leva Incontinence System For Pelvic Floor Muscle strengthening: The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion."
11334742|NCT03536923|FG000|Participant Flow|Leva Arm|"Subjects will use the leva device twice daily to perform pelvic floor muscle exercises~Leva Incontinence System For Pelvic Floor Muscle strengthening: The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone."
11334743|NCT03536923|OG000|Outcome|Leva Arm|"Subjects will use the leva device twice daily to perform pelvic floor muscle exercises~Leva Incontinence System For Pelvic Floor Muscle strengthening: The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion."
11334744|NCT03536923|EG000|Reported Event|Leva Arm|"Subjects will use the leva device twice daily to perform pelvic floor muscle exercises~Leva Incontinence System For Pelvic Floor Muscle strengthening: The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion."
11334745|NCT03536949|BG000|Baseline|RVL-1201 Ophthalmic Solution, 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days
11334746|NCT03536949|BG001|Baseline|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
11334747|NCT03536949|BG002|Baseline|Total|Total of all reporting groups
11334748|NCT03536949|FG000|Participant Flow|RVL-1201 Ophthalmic Solution, 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days
11334749|NCT03536949|FG001|Participant Flow|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
11334750|NCT03536949|OG000|Outcome|RVL-1201 Ophthalmic Solution, 0.1%|Participants with Acquired Blepharoptosis administered 1 drop of RVL-1201 in each eye once daily
11334751|NCT03536949|OG001|Outcome|Vehicle Ophthalmic Solution|Participants with Acquired Blepharoptosis administered 1 drop of Vehicle in each eye once daily
11334752|NCT03536949|EG000|Reported Event|RVL-1201 Ophthalmic Solution, 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days
11334753|NCT03536949|EG001|Reported Event|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
11334754|NCT03537092|BG000|Baseline|Vaginal Film|"Each participant who inserted a single use placebo vaginal film (Day 0) is randomized to the timing of Visit 3 (Day 3, 7, 10, or 14)~Vaginal Film: 2 x 2 vaginal film with no active drug"
11334755|NCT03537092|FG000|Participant Flow|Vaginal Film|"Each participant who inserted a single use placebo vaginal film (Day 0) is randomized to the timing of Visit 3 (Day 3, 7, 10, or 14)~Vaginal Film: 2 x 2 vaginal film with no active drug"
11334756|NCT03537092|OG000|Outcome|Vaginal Film|"Each participant who inserted a single use placebo vaginal film (Day 0) is randomized to the timing of Visit 3 (Day 3, 7, 10, or 14)~Vaginal Film: 2 x 2 vaginal film with no active drug"
11334757|NCT03537092|EG000|Reported Event|Vaginal Film|"Each participant who inserted a single use placebo vaginal film (Day 0) is randomized to the timing of Visit 3 (Day 3, 7, 10, or 14)~Vaginal Film: 2 x 2 vaginal film with no active drug"
11334758|NCT03537261|BG000|Baseline|CPI-Parent Training|"Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.~Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview."
11334759|NCT03537261|BG001|Baseline|Waitlist Control|"Will not receive active P-CPI training during the experimental treatment interval.~NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures."
11334760|NCT03537261|BG002|Baseline|Total|Total of all reporting groups
11334761|NCT03537261|FG000|Participant Flow|CPI-Parent Training|"Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.~Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview."
11335502|NCT03551743|FG003|Participant Flow|Module 4 (800 mg)|800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
11334762|NCT03537261|FG001|Participant Flow|Waitlist Control|"Will not receive active P-CPI training during the experimental treatment interval.~NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures."
11334763|NCT03537261|OG000|Outcome|CPI-Parent Training|"Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.~Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview."
11334764|NCT03537261|OG001|Outcome|Waitlist Control|"Will not receive active P-CPI training during the experimental treatment interval.~NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures."
11334765|NCT03537261|EG000|Reported Event|CPI-Parent Training|"Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.~Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview."
11334766|NCT03537261|EG001|Reported Event|Waitlist Control|"Will not receive active P-CPI training during the experimental treatment interval.~NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures."
11334767|NCT03537274|BG000|Baseline|PEG-Intron, 0.5 mg/kg|PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.
11334768|NCT03537274|BG001|Baseline|PEG-Intron, 1.0 mg/kg|PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
11334769|NCT03537274|BG002|Baseline|PEG-Intron, 1.5 mg/kg|PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
11334770|NCT03537274|BG003|Baseline|Interferon Alfa-2b|Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
11334771|NCT03537274|BG004|Baseline|Total|Total of all reporting groups
11334772|NCT03537274|FG000|Participant Flow|PEG-Intron, 0.5 mg/kg|PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection.
11334773|NCT03537274|FG001|Participant Flow|PEG-Intron, 1.0 mg/kg|PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
11334774|NCT03537274|FG002|Participant Flow|PEG-Intron, 1.5 mg/kg|PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
11334775|NCT03537274|FG003|Participant Flow|Interferon Alfa-2b|Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.
11334776|NCT03537274|OG000|Outcome|PEG-Intron, 0.5 mg/kg|PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.
11334777|NCT03537274|OG001|Outcome|PEG-Intron, 1.0 mg/kg|PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
11334778|NCT03537274|OG002|Outcome|PEG-Intron, 1.5 mg/kg|PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
11334779|NCT03537274|OG003|Outcome|Interferon Alfa-2b|Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
11334780|NCT03537274|EG000|Reported Event|PEG-Intron, 0.5 mg/kg|PEG-Intron administered QW for 48 weeks at 0.5 mg/kg SC injection.
11334781|NCT03537274|EG001|Reported Event|PEG-Intron, 1.0 mg/kg|PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
11334782|NCT03537274|EG002|Reported Event|PEG-Intron, 1.5 mg/kg|PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
11334783|NCT03537274|EG003|Reported Event|Interferon Alfa-2b|Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
11334784|NCT03537404|BG000|Baseline|Sequence A/B/C|"All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:~Treatment period 1 - Treatment A Treatment period 2 - Treatment B Treatment period 3 - Treatment C"
11334785|NCT03537404|BG001|Baseline|Sequence B/C/A|"All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:~Treatment period 1 - Treatment B Treatment period 2 - Treatment C Treatment period 3 - Treatment A"
11334786|NCT03537404|BG002|Baseline|Sequence C/A/B|"All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:~Treatment period 1 - Treatment C Treatment period 2 - Treatment A Treatment period 3 - Treatment B"
11334787|NCT03537404|BG003|Baseline|Total|Total of all reporting groups
11334788|NCT03537404|FG000|Participant Flow|Part 1|"All patients of Part 1 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 1 of the study."
11334789|NCT03537404|FG001|Participant Flow|Part 2|"All patients of Part 2 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 2 of the study."
11334790|NCT03537404|OG000|Outcome|Treatment A (Part 1)|"Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily)."
11334791|NCT03537404|OG001|Outcome|Treatment C (Part 1)|"Subjects recieved as Treatment C for 5 days (in respective treatment period):~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily)."
11334792|NCT03537404|OG002|Outcome|Treatment A (Part 2)|"Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily)."
11334793|NCT03537404|OG003|Outcome|Treatment C (Part 2)|"Subjects recieved as Treatment C for 5 days (in respective treatment period):~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily)."
11334794|NCT03537404|OG000|Outcome|Treatment B (Part 1)|"Subjects recieved as Treatment B for 5 days (in respective treatment period):~Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily)."
11334795|NCT03537404|OG000|Outcome|Treatment B (Part 2)|"Subjects recieved as Treatment B for 5 days (in respective treatment period):~Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily)."
11334796|NCT03537404|OG001|Outcome|Treatment C (Part 2)|"Subjects recieved as Treatment C for 5 days (in respective treatment period):~Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily)."
11334797|NCT03537404|OG000|Outcome|Treatment A (Part 1)|Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
11334798|NCT03537404|OG001|Outcome|Treatment B (Part 1)|Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days
11334799|NCT03537404|OG002|Outcome|Treatment C (Part 1)|"Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily~coadministered with~Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily~and~Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days"
11334800|NCT03537404|OG003|Outcome|Treatment A (Part 2)|Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
11334801|NCT03537404|OG004|Outcome|Treatment B (Part 2)|Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days
11334802|NCT03537404|OG005|Outcome|Treatment C (Part 2)|"Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily~coadministered with~Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily~and~Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days"
11334803|NCT03537404|OG000|Outcome|Treatment A (Part 1/Part 2)|Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
11334804|NCT03537404|OG001|Outcome|Treatment B (Part 1/Part 2)|"Part 1: Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days~Part 2: Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days"
11334805|NCT03537404|OG002|Outcome|Treatment C (Part 1/Part 2)|"Part 1: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days~Part 2: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days"
11334806|NCT03537404|EG000|Reported Event|Treatment A (Part 1)|Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
11334807|NCT03537404|EG001|Reported Event|Treatment B (Part 1)|Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days
11334808|NCT03537404|EG002|Reported Event|Treatment C (Part 1)|"Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily~coadministered with~Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily~and~Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days"
10846531|NCT00277394|OG000|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
11334809|NCT03537404|EG003|Reported Event|Treatment A (Part 2)|Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
11334810|NCT03537404|EG004|Reported Event|Treatment B (Part 2)|Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days
11334811|NCT03537404|EG005|Reported Event|Treatment C (Part 2)|"Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily~coadministered with~Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily~and~Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days"
11334812|NCT03537651|BG000|Baseline|TEZ/IVA|Participants from parent Studies 113B and 115 received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334813|NCT03537651|FG000|Participant Flow|TEZ/IVA|Participants from parent Studies 113B and 115 received tezacaftor (TEZ)/ivacaftor (IVA) (either TEZ 50 milligrams [mg] once daily [qd]/IVA 75 mg every 12 hours [q12h] or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334814|NCT03537651|OG000|Outcome|TEZ/IVA|Participants from parent Studies 113B and 115 received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334815|NCT03537651|OG000|Outcome|TEZ/IVA|Participants who were administered TEZ/IVA in parent Study 115 received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334816|NCT03537651|OG000|Outcome|TEZ/IVA|Participants from parent Study 113B received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334817|NCT03537651|OG000|Outcome|TEZ/IVA|Participants who were administered TEZ/IVA in parent study 115 received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334818|NCT03537651|EG000|Reported Event|TEZ/IVA|Participants from parent Studies 113B and 115 received TEZ/IVA (either TEZ 50 mg qd/IVA 75 mg q12h or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment) for 96 weeks in Part A of Study 116. Doses were adjusted upward for changes in body weight and/or age.
11334819|NCT03537664|BG000|Baseline|Root Canal Preparation and Medication|"First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation. The second endodontic treatment includes the intracanal medication with calcium hydroxide paste.~Root canal preparation: First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation.~Intracanal medication: The second endodontic treatment includes the intracanal medication with calcium hydroxide paste."
11334820|NCT03537664|FG000|Participant Flow|Total Bacteria Analysis After 1rst- and 2nd-visit Procedures|DNA levels and activity (RNA/DNA ratio) of total bacteria after the first-visit procedures (root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation) and the second-visit protocol (intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation). Additionally, the composition of the active microbiome will be assessed by Next Generation Sequencing (NGS) analysis of the root canal samples, and the success rate (apical repair) of the endodontic treatment after 1 follow-up period will be assessed by an intraoral radiograph and cone beam computed tomography (CBCT) analyses.
11334821|NCT03537664|FG001|Participant Flow|Bacterial Species Analysis After Root Canal Preparation|DNA levels and activity (RNA/DNA ratio) of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation. Additionally, the success rate (apical repair) of the endodontic treatment after 1 follow-up period will be assessed by an intraoral radiograph and cone beam computed tomography (CBCT) analyses.
11334822|NCT03537664|OG000|Outcome|Total Bacteria Analysis After 1rst- and 2nd-visit Procedures|RNA/DNA ratio of total bacteria after the first- and second-visit treatment (active bacteria with rRNA/DNA ≥ 1). First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation. The second endodontic treatment includes the intracanal medication with calcium hydroxide paste for 14 days, followed by an 2nd-visit root canal preparation.
11334823|NCT03537664|OG001|Outcome|Bacterial Species Analysis After Root Canal Preparation|RNA/DNA ratio of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation (active bacteria with rRNA/DNA ≥ 1).
11334824|NCT03537664|OG000|Outcome|Total Bacteria Analysis After 1rst- and 2nd-visit Procedures|DNA levels of total bacteria after the first-visit procedures (root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation) and the second-visit protocol (intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation).
11334825|NCT03537664|OG001|Outcome|Bacterial Species Analysis After Root Canal Preparation|DNA levels of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation.
11334826|NCT03537664|OG000|Outcome|Bacterial Composition at Baseline|Microbiome analysis in initial root canal samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
11334827|NCT03537664|OG001|Outcome|Bacterial Composition After Root Canal Preparation|Microbiome analysis in post-instrumentation samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
11334828|NCT03537664|OG002|Outcome|Bacterial Composition After Intracanal Medication|Microbiome analysis in post-medication samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
11334829|NCT03537664|OG000|Outcome|Root Canal Preparation and Medication|The success rate of the endodontic treatment after 1 follow-up period assessed by intraoral radiograph and cone beam computed tomography (CBCT) analyses.The number (%) of patients with absence/ reduction of periapical lesion are reported.
11334830|NCT03537664|EG000|Reported Event|Root Canal Preparation and Medication|First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation. The second endodontic treatment includes the intracanal medication with calcium hydroxide paste. Root canal samples from 20 patients were used to the analysis of total bacteria, Bacteroidaceae sp. HOT-272 and Cutibacterium acnes), while root canal samples from 25 patients were used for the analysis of total bacteria, Selenomonas spp. and Enterococcus faecalis
11334831|NCT03538431|BG000|Baseline|Buspirone|These participants took buspirone either before driving simulation 1 or before driving simulation 2. Those who took the medication before driving simulation visit 1 took no medication before visit 2, and those who took the medication before driving simulation visit 2 took no medication before driving simulation 1. This study is a crossover design.
11335503|NCT03551743|OG000|Outcome|Module 4 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
11335504|NCT03551743|OG001|Outcome|Module 4 (600mg)|600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
11334832|NCT03538431|FG000|Participant Flow|Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2|"These subjects will receive and be instructed to take the buspirone for the 2 days preceding their first driving simulation visit. They will not take buspirone before their 2nd driving simulation visit.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334833|NCT03538431|FG001|Participant Flow|No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2|"These subjects will receive and be instructed to take the buspirone for the 2 days preceding their second driving simulation visit. They will not take buspirone before their 1st driving simulation visit.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334834|NCT03538431|OG000|Outcome|Buspirone|"Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on buspirone, and the other half completed Simulation 2 on buspirone. These participants completed the driving simulation on buspirone.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334835|NCT03538431|OG001|Outcome|Unmedicated|"These participants completed the driving simulation unmedicated.~Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on unmedicated, and the other half completed Simulation 2 on unmedicated.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334836|NCT03538431|OG000|Outcome|Buspirone|"These participants completed the driving simulation on buspirone.~Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on buspirone, and the other half completed Simulation 2 on buspirone.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334837|NCT03538431|OG001|Outcome|Unmedicated|"These participants completed the driving simulation without buspirone.~Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 unmedicated, and the other half completed Simulation 2 unmedicated.~Buspirone: Buspirone is an atypical anxiolytic medication."
11334838|NCT03538431|EG000|Reported Event|Buspirone|These subjects received buspirone either before driving simulation visit 1 or before driving simulation 2.
11334839|NCT03538431|EG001|Reported Event|Unmedicated|These subjects received no medication either before driving simulation visit 1 or before driving simulation 2.
11334840|NCT03538678|BG000|Baseline|Kwit App|"Use of Kwit smartphone app~Kwit smartphone app: Kwit smarphone app"
11334841|NCT03538678|BG001|Baseline|Standard of Care|Patient initiated follow-up post discharge
11334842|NCT03538678|BG002|Baseline|Total|Total of all reporting groups
11334843|NCT03538678|FG000|Participant Flow|Kwit App|"Use of Kwit smartphone app~Kwit smartphone app: Kwit smarphone app"
11334844|NCT03538678|FG001|Participant Flow|Standard of Care|Patient initiated follow-up post discharge
11334845|NCT03538678|OG000|Outcome|Kwit App|"Use of Kwit smartphone app~Kwit smartphone app: Kwit smarphone app"
11334846|NCT03538678|OG001|Outcome|Standard of Care|Patient initiated follow-up post discharge
11334847|NCT03538678|EG000|Reported Event|Kwit App|"Use of Kwit smartphone app~Kwit smartphone app: Kwit smarphone app"
11334848|NCT03538678|EG001|Reported Event|Standard of Care|Patient initiated follow-up post discharge
11334849|NCT03538743|BG000|Baseline|Placebo|Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
11334850|NCT03538743|BG001|Baseline|PF-06882961 10mg BID|PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
11334851|NCT03538743|BG002|Baseline|PF-06882961 15mg BID|PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
11334852|NCT03538743|BG003|Baseline|PF-06882961 50mg BID|PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
11334853|NCT03538743|BG004|Baseline|PF-06882961 70mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
11334854|NCT03538743|BG005|Baseline|PF-06882961 120mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
11334855|NCT03538743|BG006|Baseline|PF-06882961 120mg BID ST|PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
11334856|NCT03538743|BG007|Baseline|PF-06882961 120mg QD|PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
11334857|NCT03538743|BG008|Baseline|PF-06882961 200mg QD CR|PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
11334858|NCT03538743|BG009|Baseline|Total|Total of all reporting groups
11334859|NCT03538743|FG000|Participant Flow|Placebo|Placebo matched to PF-06882961 was administered orally once daily (QD) or twice daily (BID) (dependent upon corresponding study treatment regimen) for a total of 28 days.
11334860|NCT03538743|FG001|Participant Flow|PF-06882961 10mg BID|PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
11334861|NCT03538743|FG002|Participant Flow|PF-06882961 15mg BID|PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
11334862|NCT03538743|FG003|Participant Flow|PF-06882961 50mg BID|PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
11334863|NCT03538743|FG004|Participant Flow|PF-06882961 70mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
11334864|NCT03538743|FG005|Participant Flow|PF-06882961 120mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
11334865|NCT03538743|FG006|Participant Flow|PF-06882961 120mg BID Slow Titration (ST)|PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
11336407|NCT03566238|BG001|Baseline|A4250 High Dose|"Capsules for oral administration (120 ug/kg) once daily for 24 weeks~A4250 (odevixibat): A4250 is a small molecule and selective inhibitor of IBAT."
11334866|NCT03538743|FG007|Participant Flow|PF-06882961 120mg QD|PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
11334867|NCT03538743|FG008|Participant Flow|PF-06882961 200mg QD Controlled Release (CR)|PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
11334868|NCT03538743|OG000|Outcome|Placebo|Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
11334869|NCT03538743|OG001|Outcome|PF-06882961 10mg BID|PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
11334870|NCT03538743|OG002|Outcome|PF-06882961 15mg BID|PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
11334871|NCT03538743|OG003|Outcome|PF-06882961 50mg BID|PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
11334872|NCT03538743|OG004|Outcome|PF-06882961 70mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
11334873|NCT03538743|OG005|Outcome|PF-06882961 120mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
11334874|NCT03538743|OG006|Outcome|PF-06882961 120mg BID ST|PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
11334875|NCT03538743|OG007|Outcome|PF-06882961 120mg QD|PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
11334876|NCT03538743|OG008|Outcome|PF-06882961 200mg QD CR|PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
11334877|NCT03538743|OG000|Outcome|PF-06882961 15mg BID (Cohort 1)|PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
11334878|NCT03538743|OG001|Outcome|PF-06882961 50mg BID (Cohort 2)|PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
11334879|NCT03538743|OG002|Outcome|PF-06882961 70mg BID (Cohort 3)|PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
11334880|NCT03538743|OG003|Outcome|PF-06882961 120mg BID (Cohort 4)|PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
11334881|NCT03538743|OG004|Outcome|PF-06882961 10mg BID (Cohort 5)|PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
11334882|NCT03538743|OG005|Outcome|PF-06882961 120mg BID ST (Cohort 6)|PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
11334883|NCT03538743|OG006|Outcome|PF-06882961 200mg QD CR (Cohort 7)|PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
11334884|NCT03538743|OG007|Outcome|PF-06882961 120mg QD (Cohort 8)|PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
11334885|NCT03538743|EG000|Reported Event|Placebo|Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
11334886|NCT03538743|EG001|Reported Event|PF-06882961 10mg BID|PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
11334887|NCT03538743|EG002|Reported Event|PF-06882961 15mg BID|PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
11334888|NCT03538743|EG003|Reported Event|PF-06882961 50mg BID|PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
11334889|NCT03538743|EG004|Reported Event|PF-06882961 70mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
11334890|NCT03538743|EG005|Reported Event|PF-06882961 120mg BID|PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
11334891|NCT03538743|EG006|Reported Event|PF-06882961 120mg BID ST|PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
11334892|NCT03538743|EG007|Reported Event|PF-06882961 120mg QD|PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
11334893|NCT03538743|EG008|Reported Event|PF-06882961 200mg QD CR|PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
11334894|NCT03538795|BG000|Baseline|iTBS&eCIMT|Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing. iTBS&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS (which include time for set-up and transition)
11336594|NCT03569033|EG000|Reported Event|MK-7264 45 mg BID|Participants received a gefapixant 45 mg tablet BID for 7 days.
11334895|NCT03538795|FG000|Participant Flow|iTBS&eCIMT|Participants will first receive baseline testing followed by a no-treatment control period. Will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing. Intermittent Theta Burst Stimulation (iTBS) & Expanded Constraint-Induced Movement Therapy (eCIMT): All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with neurodevelopmental techniques (NDT) techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced.
11334896|NCT03538795|OG000|Outcome|iTBS&eCIMT|Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing. iTBS&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS and 1-hour periods of eCIMT.
11334897|NCT03538795|EG000|Reported Event|iTBS&eCIMT|Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing. iTBS&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS and 1-hour periods of eCIMT.
11334898|NCT03538808|BG000|Baseline|Therapeutic Dose/Varenicline|Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
11334899|NCT03538808|BG001|Baseline|Therapeutic Dose/Placebo|Participants were told they received a therapeutic dose varenicline, but they received a placebo.
11334900|NCT03538808|BG002|Baseline|Low Dose/Varenicline|Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
11334901|NCT03538808|BG003|Baseline|Low Dose/Placebo|Participants were told they received a very low dose varenicline, but they received a placebo.
11334902|NCT03538808|BG004|Baseline|Total|Total of all reporting groups
11334903|NCT03538808|FG000|Participant Flow|Therapeutic Dose/Varenicline|Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication
11334904|NCT03538808|FG001|Participant Flow|Therapeutic Dose/Placebo|Participants were told they received a therapeutic dose varenicline, but they received a placebo.
11334905|NCT03538808|FG002|Participant Flow|Low Dose/Varenicline|Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
11334906|NCT03538808|FG003|Participant Flow|Low Dose/Placebo|Participants were told they received a very low dose varenicline, but they received a placebo.
11334907|NCT03538808|OG000|Outcome|Therapeutic Dose/Varenicline|Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
11334908|NCT03538808|OG001|Outcome|Therapeutic Dose/Placebo|Participants were told they received a therapeutic dose varenicline, but they received a placebo.
11334909|NCT03538808|OG002|Outcome|Low Dose/Varenicline|Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
11334910|NCT03538808|OG003|Outcome|Low Dose/Placebo|Participants were told they received a very low dose varenicline, but they received a placebo.
11334911|NCT03538808|EG000|Reported Event|Therapeutic Dose/Varenicline|Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
11334912|NCT03538808|EG001|Reported Event|Therapeutic Dose/Placebo|Participants were told they received a therapeutic dose varenicline, but they received a placebo.
11334913|NCT03538808|EG002|Reported Event|Low Dose/Varenicline|Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
11334914|NCT03538808|EG003|Reported Event|Low Dose/Placebo|Participants were told they received a very low dose varenicline, but they received a placebo.
11334915|NCT03539211|BG000|Baseline|Rotation Exercises|"8 minute program of rotation based exercises~Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each"
11334916|NCT03539211|BG001|Baseline|Control Exercises|"8 minute program of traditional exercises~Control Exercises: The subjects received 7 traditional exercises x 10 reps each"
11334917|NCT03539211|BG002|Baseline|Total|Total of all reporting groups
11334918|NCT03539211|FG000|Participant Flow|Rotation Exercises|"8 minute program of rotation based exercises~Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each"
11334919|NCT03539211|FG001|Participant Flow|Control Exercises|"8 minute program of traditional exercises~Control Exercises: The subjects received 7 traditional exercises x 10 reps each"
11334920|NCT03539211|OG000|Outcome|Rotation Exercises|"8 minute program of rotation based exercises~Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each"
11334921|NCT03539211|OG001|Outcome|Control Exercises|"8 minute program of traditional exercises~Control Exercises: The subjects received 7 traditional exercises x 10 reps each"
11334922|NCT03539211|EG000|Reported Event|Rotation Exercises|"8 minute program of rotation based exercises~Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each"
11334923|NCT03539211|EG001|Reported Event|Control Exercises|"8 minute program of traditional exercises~Control Exercises: The subjects received 7 traditional exercises x 10 reps each"
11334924|NCT03539432|BG000|Baseline|Gemfibrozil|"Gemfibrozil 600 mg by mouth twice daily~Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day"
11334925|NCT03539432|BG001|Baseline|Placebo|"Microcrystalline cellulose powder packaged in capsules identical to the experimental condition~Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication"
11334926|NCT03539432|BG002|Baseline|Total|Total of all reporting groups
11334927|NCT03539432|FG000|Participant Flow|Gemfibrozil|"Gemfibrozil 600 mg by mouth twice daily~Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day"
11334928|NCT03539432|FG001|Participant Flow|Placebo|"Microcrystalline cellulose powder packaged in capsules identical to the experimental condition~Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication"
11334929|NCT03539432|OG000|Outcome|Gemfibrozil|"Gemfibrozil 600 mg by mouth twice daily~Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day"
11334930|NCT03539432|OG001|Outcome|Placebo|"Microcrystalline cellulose powder packaged in capsules identical to the experimental condition~Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication"
11334931|NCT03539432|EG000|Reported Event|Gemfibrozil|"Gemfibrozil 600 mg by mouth twice daily~Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day"
11334932|NCT03539432|EG001|Reported Event|Placebo|"Microcrystalline cellulose powder packaged in capsules identical to the experimental condition~Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication"
11334933|NCT03539484|BG000|Baseline|PART1 - RO7172508 - Q3W - 65 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
11334934|NCT03539484|BG001|Baseline|PART1 - RO7172508 - Q3W - 160 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
11334935|NCT03539484|BG002|Baseline|PART1 - RO7172508 - Q3W - 400 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
11334936|NCT03539484|BG003|Baseline|PART2 - RO7172508 - Q3W - 400 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
11334937|NCT03539484|BG004|Baseline|PART2 - RO7172508 - Q3W - 800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
11334938|NCT03539484|BG005|Baseline|PART2 - RO7172508 - Q3W - 1200 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
11334939|NCT03539484|BG006|Baseline|PART2 - RO7172508 - Q3W - 1800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
11334940|NCT03539484|BG007|Baseline|Total|Total of all reporting groups
11334941|NCT03539484|FG000|Participant Flow|PART1 - RO7172508 - Q3W - 65 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
11334942|NCT03539484|FG001|Participant Flow|PART1 - RO7172508 - Q3W - 160 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
11334943|NCT03539484|FG002|Participant Flow|PART1 - RO7172508 - Q3W - 400 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
11334944|NCT03539484|FG003|Participant Flow|PART2 - RO7172508 - Q3W - 400 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
11334945|NCT03539484|FG004|Participant Flow|PART2 - RO7172508 - Q3W - 800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
11334946|NCT03539484|FG005|Participant Flow|PART2 - RO7172508 - Q3W - 1200 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
11334947|NCT03539484|FG006|Participant Flow|PART2 - RO7172508 - Q3W - 1800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
11334948|NCT03539484|OG000|Outcome|Part I: Single Participant Cohort IV RO7172508 65 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
11334949|NCT03539484|OG001|Outcome|Part I: Single Participant Cohort IV RO7172508 160 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
11334950|NCT03539484|OG002|Outcome|Part I: Single Participant Cohort IV RO7172508 400 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
11334951|NCT03539484|OG003|Outcome|Part II: Multiple Participant Cohorts IV 400 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
11334952|NCT03539484|OG004|Outcome|Part II: Multiple Participant Cohorts IV 800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
11334953|NCT03539484|OG005|Outcome|Part II: Multiple Participant Cohorts IV 1200 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
11334954|NCT03539484|OG006|Outcome|Part II: Multiple Participant Cohorts IV 1800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
11334955|NCT03539484|OG002|Outcome|Part I and Part II: Participant Cohorts IV 400 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg). Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
11334956|NCT03539484|OG003|Outcome|Part II: Multiple Participant Cohorts IV 800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
11334957|NCT03539484|OG004|Outcome|Part II: Multiple Participant Cohorts IV 1200 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
11334958|NCT03539484|OG005|Outcome|Part II: Multiple Participant Cohorts IV 1800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
11334959|NCT03539484|OG000|Outcome|Part I: Single Participant Cohort IV RO7172508 65 mcgEdit|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
11334960|NCT03539484|EG000|Reported Event|PART1 - RO7172508 - Q3W - 65 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
11334961|NCT03539484|EG001|Reported Event|PART1 - RO7172508 - Q3W - 160 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
11334962|NCT03539484|EG002|Reported Event|PART1 - RO7172508 - Q3W - 400 mcg|Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
11334963|NCT03539484|EG003|Reported Event|PART2 - RO7172508 - Q3W - 400 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
11334964|NCT03539484|EG004|Reported Event|PART2 - RO7172508 - Q3W - 800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
11334965|NCT03539484|EG005|Reported Event|PART2 - RO7172508 - Q3W - 1200 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
11334966|NCT03539484|EG006|Reported Event|PART2 - RO7172508 - Q3W - 1800 mcg|Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
11334967|NCT03539549|BG000|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
11334968|NCT03539549|FG000|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
11334969|NCT03539549|OG000|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
11334970|NCT03539549|EG000|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
11334971|NCT03540030|BG000|Baseline|Observational|The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.
11334972|NCT03540030|BG001|Baseline|Non-Opioid Intervention|Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
11334973|NCT03540030|BG002|Baseline|Total|Total of all reporting groups
11334974|NCT03540030|FG000|Participant Flow|Observational|The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.
11335396|NCT03549429|OG000|Outcome|TegadermTM|TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid.
11335505|NCT03551743|OG002|Outcome|Module 4 (800 mg Bolus + 480 mg Infusion)|800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
10849677|NCT00297427|OG000|Outcome|True Acupuncture|True Acupuncture twice weekly for 6 weeks.
11334975|NCT03540030|FG001|Participant Flow|Non-Opioid Intervention|Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
11334976|NCT03540030|OG000|Outcome|Observational|The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.
11334977|NCT03540030|OG001|Outcome|Non-Opioid Intervention|Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
11334978|NCT03540030|EG000|Reported Event|Observational|The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.
11334979|NCT03540030|EG001|Reported Event|Non-Opioid Intervention|Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
11334980|NCT03540134|BG000|Baseline|Intracerebral Infusion of Autologous CSF|"All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.~Intracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring"
11334981|NCT03540134|FG000|Participant Flow|Intracerebral Infusion of Autologous CSF|"All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.~Intracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring"
11334982|NCT03540134|OG000|Outcome|Intracerebral Infusion of Autologous CSF|"All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.~Intracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring"
11334983|NCT03540134|EG000|Reported Event|Intracerebral Infusion of Autologous CSF|"All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.~Intracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring"
11335397|NCT03549429|OG001|Outcome|EyeGard®|TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid.
11335398|NCT03549429|EG000|Reported Event|TegadermTM on R Eye, EyeGard® on L Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11334984|NCT03540147|BG000|Baseline|Blood Flow Restriction Exercise|"Participants will walk on the treadmill with Hokanson cuffs inflated.~Hokanson Cuffs: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant."
11334985|NCT03540147|FG000|Participant Flow|Blood Flow Restriction Exercise|"This is a cross-over study. Each subject performed all 5 experimental conditions that includes exercise with Hokanson cuffs, Exercise with BStrong bands, Exercise without inflated bands/cuffs, Yoga poses with BStrong bands inflated and Yoga poses with BStrong bands uninflated."
11334986|NCT03540147|OG000|Outcome|Exercise With Hokanson Cuffs|"Participants will walk on the treadmill with Hokanson cuffs inflated.~Hokanson Cuffs: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant."
11334987|NCT03540147|OG001|Outcome|Exercise With BStrong Bands|"Participants will walk on the treadmill with BStrong bands inflated.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334988|NCT03540147|OG002|Outcome|Exercise Without Inflated Bands/Cuffs|"Participants will walk on the treadmill with non-inflated BStrong bands.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334989|NCT03540147|OG003|Outcome|Yoga Poses With BStrong Bands Inflated|"Participants will perform 15-20 yoga poses with BStrong bands inflated.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334990|NCT03540147|OG004|Outcome|Yoga Poses With BStrong Bands Uninflated|"Participants will perform 15-20 yoga poses with uninflated BStrong bands.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334991|NCT03540147|EG000|Reported Event|Exercise With Hokanson Cuffs|"Participants will walk on the treadmill with Hokanson cuffs inflated.~Hokanson Cuffs: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant."
11334992|NCT03540147|EG001|Reported Event|Exercise With BStrong Bands|"Participants will walk on the treadmill with BStrong bands inflated.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334993|NCT03540147|EG002|Reported Event|Exercise Without Inflated Bands/Cuffs|"Participants will walk on the treadmill with non-inflated BStrong bands.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334994|NCT03540147|EG003|Reported Event|Yoga Poses With BStrong Bands Inflated|"Participants will perform 15-20 yoga poses with BStrong bands inflated.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334995|NCT03540147|EG004|Reported Event|Yoga Poses With BStrong Bands Uninflated|"Participants will perform 15-20 yoga poses with uninflated BStrong bands.~BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant."
11334996|NCT03540160|BG000|Baseline|Serlopitant 5 mg|Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
11334997|NCT03540160|FG000|Participant Flow|Serlopitant 5 mg|Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
11334998|NCT03540160|OG000|Outcome|Serlopitant 5 mg|Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
11334999|NCT03540160|EG000|Reported Event|Serlopitant 5 mg|Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
11335000|NCT03541044|BG000|Baseline|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:2mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:2mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335001|NCT03541044|FG000|Participant Flow|Prototype-Washout-Nicorette|Participants randomized to this group received a single dose of Treatment A: 2 milligrams (mg) of Prototype Mini Lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment B: 2 mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired carbon monoxide (CO) to confirm abstinence (CO levels must have been less than or equal to[<=] 10 parts per million [ppm] throughout the treatment period).
11335002|NCT03541044|FG001|Participant Flow|Nicorette-Washout-Prototype|Participants randomized to this group received a single dose of Treatment B: 2 mg of Nicorette Mini lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment A: 2 mg of Prototype Mini Lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335003|NCT03541044|OG000|Outcome|Prototype Mini Lozenges|Participants randomized to receive a single dose of Treatment A: 2 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335004|NCT03541044|OG001|Outcome|Nicorette Mini Lozenges|Participants randomized to receive a single dose of Treatment B: 2 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335005|NCT03541044|OG002|Outcome|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:2mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:2mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335006|NCT03541044|EG000|Reported Event|Prototype Mini Lozenges|Participants randomized to receive a single dose of Treatment A: 2 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335007|NCT03541044|EG001|Reported Event|Nicorette Mini Lozenges|Participants randomized to receive a single dose of Treatment B: 2 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335008|NCT03541044|EG002|Reported Event|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:2mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:2mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335009|NCT03541356|BG000|Baseline|Placebo|Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
11335010|NCT03541356|BG001|Baseline|L-dopa 35 mg|L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
11335011|NCT03541356|BG002|Baseline|L-dopa 70 mg|L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335012|NCT03541356|BG003|Baseline|L-dopa 140 mg|L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
11335013|NCT03541356|BG004|Baseline|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335014|NCT03541356|BG005|Baseline|Total|Total of all reporting groups
11335015|NCT03541356|FG000|Participant Flow|Placebo|Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
11335016|NCT03541356|FG001|Participant Flow|L-dopa 35 mg|L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
11335017|NCT03541356|FG002|Participant Flow|L-dopa 70 mg|L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335018|NCT03541356|FG003|Participant Flow|L-dopa 140 mg|L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
11335019|NCT03541356|FG004|Participant Flow|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335020|NCT03541356|OG000|Outcome|Placebo|Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
11335021|NCT03541356|OG001|Outcome|L-dopa 35 mg|L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
11335022|NCT03541356|OG002|Outcome|L-dopa 70 mg|L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335023|NCT03541356|OG003|Outcome|L-dopa 140 mg|L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
11335024|NCT03541356|OG004|Outcome|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335025|NCT03541356|OG000|Outcome|L-dopa 35 mg|L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
11335026|NCT03541356|OG001|Outcome|L-dopa 70 mg|L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335027|NCT03541356|OG002|Outcome|L-dopa 140 mg|L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
11335028|NCT03541356|OG003|Outcome|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335029|NCT03541356|OG000|Outcome|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335030|NCT03541356|EG000|Reported Event|Placebo|Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
11335031|NCT03541356|EG001|Reported Event|L-dopa 35 mg|L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
11335032|NCT03541356|EG002|Reported Event|L-dopa 70 mg|L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335033|NCT03541356|EG003|Reported Event|L-dopa 140 mg|L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
11335034|NCT03541356|EG004|Reported Event|L-dopa 70 mg/Carbidopa 7 mg|L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
11335035|NCT03541941|BG000|Baseline|Exparel|"Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335036|NCT03541941|BG001|Baseline|Bupivacaine Hcl 0.25% Inj|"Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335037|NCT03541941|BG002|Baseline|Placebo|"120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block"
11335038|NCT03541941|BG003|Baseline|Total|Total of all reporting groups
11335039|NCT03541941|FG000|Participant Flow|Exparel|"Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335040|NCT03541941|FG001|Participant Flow|Bupivacaine Hcl 0.25% Inj|"Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335041|NCT03541941|FG002|Participant Flow|Placebo|"120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block"
11335042|NCT03541941|OG000|Outcome|Exparel|"Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335043|NCT03541941|OG001|Outcome|Bupivacaine Hcl 0.25% Inj|"Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335044|NCT03541941|OG002|Outcome|Placebo|"120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block"
11335045|NCT03541941|EG000|Reported Event|Exparel|"Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335046|NCT03541941|EG001|Reported Event|Bupivacaine Hcl 0.25% Inj|"Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block"
11335506|NCT03551743|OG003|Outcome|Module 4 (800 mg)|800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
10849678|NCT00297427|OG001|Outcome|Sham Acupuncture|Sham acupuncture twice weekly for 6 weeks
11335047|NCT03541941|EG002|Reported Event|Placebo|"120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization~Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block"
11335048|NCT03541980|BG000|Baseline|Intervention|"Patients allocated to receive IV acetaminophen~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen"
11335049|NCT03541980|BG001|Baseline|Placebo|"Patients allocated to receive IV normal saline placebo~Normal saline: Normal saline volume equivalent"
11335050|NCT03541980|BG002|Baseline|Total|Total of all reporting groups
11335051|NCT03541980|FG000|Participant Flow|Intervention|"Patients allocated to receive IV acetaminophen-35~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen"
11335052|NCT03541980|FG001|Participant Flow|Placebo|"Patients allocated to receive IV normal saline placebo-36~Normal saline: Normal saline volume equivalent"
11335053|NCT03541980|OG000|Outcome|Intervention|"Patients allocated to receive IV acetaminophen~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen~.2mg/kg"
11335054|NCT03541980|OG001|Outcome|Placebo|"Patients allocated to receive IV normal saline placebo~Normal saline: Normal saline volume equivalent~.2mg/kg"
11335055|NCT03541980|OG000|Outcome|Intervention|"Patients allocated to receive IV acetaminophen~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen 5.5"
11335056|NCT03541980|OG001|Outcome|Placebo|"Patients allocated to receive IV normal saline placebo~Normal saline: Normal saline volume equivalent 5.2"
11335057|NCT03541980|OG000|Outcome|Intervention|"Patients allocated to receive IV acetaminophen~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen"
11335058|NCT03541980|OG001|Outcome|Placebo|"Patients allocated to receive IV normal saline placebo~Normal saline: Normal saline volume equivalent"
11335059|NCT03541980|OG000|Outcome|Intervention|"Patients allocated to receive IV acetaminophen-35~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen"
11335060|NCT03541980|OG001|Outcome|Placebo|"Patients allocated to receive IV normal saline placebo-36~Normal saline: Normal saline volume equivalent"
11335061|NCT03541980|EG000|Reported Event|Intervention|"Patients allocated to receive IV acetaminophen~Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen~none"
11335062|NCT03541980|EG001|Reported Event|Placebo|"Patients allocated to receive IV normal saline placebo~Normal saline: Normal saline volume equivalent~none"
11335063|NCT03542019|BG000|Baseline|Lithium Disilicate|"Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns~Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain"
11335064|NCT03542019|BG001|Baseline|Monolithic Zirconia|"Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns~Dental crown: Replacement og missing tooth structure using monolithic zirconia"
11335065|NCT03542019|BG002|Baseline|Hybrid Ceramic|"Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns~Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic"
11335066|NCT03542019|BG003|Baseline|Total|Total of all reporting groups
11335067|NCT03542019|FG000|Participant Flow|Lithium Disilicate|"Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns~Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain"
11335068|NCT03542019|FG001|Participant Flow|Monolithic Zirconia|"Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns~Dental crown: Replacement og missing tooth structure using monolithic zirconia"
11335069|NCT03542019|FG002|Participant Flow|Hybrid Ceramic|"Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns~Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic"
11335070|NCT03542019|OG000|Outcome|Lithium Disilicate|"Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns~Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain"
11335071|NCT03542019|OG001|Outcome|Monolithic Zirconia|"Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns~Dental crown: Replacement og missing tooth structure using monolithic zirconia"
11335072|NCT03542019|OG002|Outcome|Hybrid Ceramic|"Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns~Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic"
11335073|NCT03542019|EG000|Reported Event|Lithium Disilicate|"Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns~Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain"
11335074|NCT03542019|EG001|Reported Event|Monolithic Zirconia|"Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns~Dental crown: Replacement og missing tooth structure using monolithic zirconia"
11335399|NCT03549429|EG001|Reported Event|TegadermTM on L Eye, EyeGard® on R Eye|Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
11335075|NCT03542019|EG002|Reported Event|Hybrid Ceramic|"Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns~Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic"
11335076|NCT03542305|BG000|Baseline|Normal Function|Participants with normal renal function received a 100 mg dose of lorlatinib tablets with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335077|NCT03542305|BG001|Baseline|Mild Impairment|Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335078|NCT03542305|BG002|Baseline|Moderate Impairment|Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335079|NCT03542305|BG003|Baseline|Severe Impairment|Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335080|NCT03542305|BG004|Baseline|Total|Total of all reporting groups
11335081|NCT03542305|FG000|Participant Flow|Normal Function|Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335082|NCT03542305|FG001|Participant Flow|Mild Impairment|Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335083|NCT03542305|FG002|Participant Flow|Moderate Impairment|Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335084|NCT03542305|FG003|Participant Flow|Severe Impairment|Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335085|NCT03542305|OG000|Outcome|Normal Function|Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335086|NCT03542305|OG001|Outcome|Mild Impairment|Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335087|NCT03542305|OG002|Outcome|Moderate Impairment|Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335088|NCT03542305|OG003|Outcome|Severe Impairment|Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335089|NCT03542305|EG000|Reported Event|Normal Function|Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335090|NCT03542305|EG001|Reported Event|Mild Impairment|Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335091|NCT03542305|EG002|Reported Event|Moderate Impairment|Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335092|NCT03542305|EG003|Reported Event|Severe Impairment|Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
11335093|NCT03542474|BG000|Baseline|Exercise|"6 months of high intensity endurance exercise on a treadmill (3 times per week)~High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months."
11335094|NCT03542474|FG000|Participant Flow|Exercise|"6 months of high intensity endurance exercise on a treadmill (3 times per week)~High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months."
11335095|NCT03542474|OG000|Outcome|Exercise|"6 months of high intensity endurance exercise on a treadmill (3 times per week)~High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months."
11335096|NCT03542474|EG000|Reported Event|Exercise|"6 months of high intensity endurance exercise on a treadmill (3 times per week)~High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months."
11335097|NCT03543085|BG000|Baseline|Ultrahigh Frequency (500 KHz) Stimulation|"This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultrahigh frequency spinal cord stimulation in patients with chronic back pain or lower limb pain.~GiMer Medical MN 1000 External Stimulator: Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11335491|NCT03551730|EG001|Reported Event|Module 3 (210 mg Andexanet) Original Formulation|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335098|NCT03543085|FG000|Participant Flow|Ultrahigh Frequency (500 KHz) Stimulation|"This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultrahigh frequency spinal cord stimulation in patients with chronic back pain or lower limb pain.~GiMer Medical MN 1000 External Stimulator: Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11335099|NCT03543085|OG000|Outcome|Ultrahigh Frequency (500 KHz) Stimulation|"This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultrahigh frequency spinal cord stimulation in patients with chronic back pain or lower limb pain.~GiMer Medical MN 1000 External Stimulator: Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11335100|NCT03543085|EG000|Reported Event|Ultrahigh Frequency (500 KHz) Stimulation|"This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultrahigh frequency spinal cord stimulation in patients with chronic back pain or lower limb pain.~GiMer Medical MN 1000 External Stimulator: Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range."
11335101|NCT03543137|BG000|Baseline|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335102|NCT03543137|FG000|Participant Flow|Prototype-Washout-Nicorette|Participants randomized to this group received a single dose of Treatment A: 4 milligrams (mg) of Prototype Mini Lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment B: 4 mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired carbon monoxide (CO) to confirm abstinence (CO levels must have been less than or equal to(<=) 10 parts per million (ppm) throughout the treatment period).
11335103|NCT03543137|FG001|Participant Flow|Nicorette-Washout-Prototype|Participants randomized to this group received a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment A: 4 mg of Prototype Mini Lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335104|NCT03543137|OG000|Outcome|Prototype Mini Lozenges|Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335105|NCT03543137|OG001|Outcome|Nicorette Mini Lozenges|Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335106|NCT03543137|OG002|Outcome|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335107|NCT03543137|EG000|Reported Event|Prototype Mini Lozenges|Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335108|NCT03543137|EG001|Reported Event|Nicorette Mini Lozenges|Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <= 10 ppm throughout the treatment period).
11335109|NCT03543137|EG002|Reported Event|All Treatment Combined|All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been <=10 ppm throughout the treatment period).
11335110|NCT03543176|BG000|Baseline|Umeclidinium/Vilanterol|Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta
11335111|NCT03543176|BG001|Baseline|Fluticasone /Salmeterol|Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
11335112|NCT03543176|BG002|Baseline|Total|Total of all reporting groups
11335113|NCT03543176|FG000|Participant Flow|Umeclidinium/Vilanterol|Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta
11335114|NCT03543176|FG001|Participant Flow|Fluticasone /Salmeterol|Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
11335115|NCT03543176|OG000|Outcome|Umeclidinium/Vilanterol|Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta
11335116|NCT03543176|OG001|Outcome|Fluticasone /Salmeterol|Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
11335117|NCT03543176|EG000|Reported Event|Umeclidinium/Vilanterol|Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta
11335118|NCT03543176|EG001|Reported Event|Fluticasone /Salmeterol|Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
11335119|NCT03543878|BG000|Baseline|Flicker/Flicker|Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.
11335120|NCT03543878|BG001|Baseline|No Flicker/Flicker|Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
11335121|NCT03543878|BG002|Baseline|Total|Total of all reporting groups
11335122|NCT03543878|FG000|Participant Flow|Flicker/Flicker|Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.
11335123|NCT03543878|FG001|Participant Flow|No Flicker/Flicker|Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
11335124|NCT03543878|OG000|Outcome|Flicker/Flicker|Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.
11335125|NCT03543878|OG001|Outcome|No Flicker/Flicker|Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
11335126|NCT03543878|OG000|Outcome|All Study Participants|Participants receiving the Flicker exposure in either the Flicker/Flicker or No Flicker/Flicker study arm.
11335127|NCT03543878|EG000|Reported Event|Flicker/Flicker|Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.
11335128|NCT03543878|EG001|Reported Event|No Flicker/Flicker|Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
11335129|NCT03544216|BG000|Baseline|Single Vision First|"Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.~Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks"
11335130|NCT03544216|BG001|Baseline|Multifocal First|"Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks.~Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks"
10849679|NCT00297427|OG000|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
11335131|NCT03544216|BG002|Baseline|Total|Total of all reporting groups
11335507|NCT03551743|EG000|Reported Event|Module 4 Placebo|Placebo administered IV as a bolus or a bolus followed by continuous infusion.
11335132|NCT03544216|FG000|Participant Flow|Single Vision First|"Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.~Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks"
11335133|NCT03544216|FG001|Participant Flow|Multifocal First|"Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks.~Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks"
11335134|NCT03544216|OG000|Outcome|CLDEQ-8 With Multifocal Contact Lens|Mean CLDEQ-8 score across both groups (single vision first and multifocal first)(n = 84) with the multifocal contact lens
11335135|NCT03544216|OG001|Outcome|CLDEQ-8 With Single Vision Contact Lens|Mean CLDEQ-8 score across both groups treatment groups (single vision first and multifocal first)(n = 84) with the single vision contact lens
11335136|NCT03544216|OG002|Outcome|CLDEQ-8 With Habitual Contact Lenses|Mean CLDEQ-8 score across both groups (single vision first and multifocal first)(n=84) at baseline with each subject's habitual contact lenses
11335137|NCT03544216|EG000|Reported Event|Single Vision Contact Lens|All subjects wore the single vision (Bausch + Lomb ULTRA®) lens for approximately 2 weeks during the study.
11335138|NCT03544216|EG001|Reported Event|Multifocal Contact Lens|All subjects wore the multifocal vision (Bausch + Lomb ULTRA® for Presbyopia) lens for approximately 2 weeks during the study.
11335139|NCT03544307|BG000|Baseline|Taekwondo Training|"Taekwondo training was performed 60 minutes/day, 3 days/week for 12-weeks. Exercise intensity was set at 30-40% of heart rate reserve (HRR) and gradually increased to 50-60% over 12 weeks.~Taekwondo training: Exercise group"
11335140|NCT03544307|BG001|Baseline|Control|Sedentary control asked not to exercise
11335141|NCT03544307|BG002|Baseline|Total|Total of all reporting groups
11335142|NCT03544307|FG000|Participant Flow|Taekwondo Training|"Taekwondo training was performed 60 minutes/day, 3 days/week for 12-weeks. Exercise intensity was set at 30-40% of heart rate reserve (HRR) and gradually increased to 50-60% over 12 weeks.~Taekwondo training: Exercise group"
11335143|NCT03544307|FG001|Participant Flow|Control|Sedentary control asked not to exercise
11335144|NCT03544307|OG000|Outcome|Taekwondo Training|"Taekwondo training was performed 60 minutes/day, 3 days/week for 12-weeks. Exercise intensity was set at 30-40% of heart rate reserve (HRR) and gradually increased to 50-60% over 12 weeks.~Taekwondo training: Exercise group"
11335145|NCT03544307|OG001|Outcome|Control|Sedentary control asked not to exercise
11335146|NCT03544307|EG000|Reported Event|Taekwondo Training|"Taekwondo training was performed 60 minutes/day, 3 days/week for 12-weeks. Exercise intensity was set at 30-40% of heart rate reserve (HRR) and gradually increased to 50-60% over 12 weeks.~Taekwondo training: Exercise group"
11335147|NCT03544307|EG001|Reported Event|Control|Sedentary control asked not to exercise
11335148|NCT03544333|BG000|Baseline|Real Transcranial Magnetic Stimulation|"In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.~Transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335149|NCT03544333|BG001|Baseline|Sham Transcranial Magnetic Stimulation|"In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.~Transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335150|NCT03544333|BG002|Baseline|Total|Total of all reporting groups
11335151|NCT03544333|FG000|Participant Flow|Real Transcranial Magnetic Stimulation|"In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.~transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335152|NCT03544333|FG001|Participant Flow|Sham Transcranial Magnetic Stimulation|"In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.~transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335492|NCT03551730|EG002|Reported Event|Module 3 (420 mg Andexanet) Original Forumulation|420 mg andexanet IV bolus over 14 minutes (~30 mg/min) 420 mg andexanet IV bolus over 14 minutes (~30 mg/min)
10843386|NCT00254293|BG001|Baseline|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10843387|NCT00254293|BG002|Baseline|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
10843388|NCT00254293|BG003|Baseline|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
10843389|NCT00254293|BG004|Baseline|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10843390|NCT00254293|BG005|Baseline|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
10843391|NCT00254293|BG006|Baseline|Total|Total of all reporting groups
10843392|NCT00254293|FG000|Participant Flow|Group 1: 500 mg IV/75 mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843393|NCT00254293|FG001|Participant Flow|Group 2: 500 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843394|NCT00254293|FG002|Participant Flow|Group 3 : 750 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843395|NCT00254293|FG003|Participant Flow|Group 4: 1000mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843396|NCT00254293|FG004|Participant Flow|Group 5: 1000 mg IV/200 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843397|NCT00254293|FG005|Participant Flow|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843398|NCT00254293|FG006|Participant Flow|Fixed Dose 125 mg Abatacept|Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
11335153|NCT03544333|OG000|Outcome|Real Transcranial Magnetic Stimulation|"In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.~TMS: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335154|NCT03544333|OG001|Outcome|Sham Transcranial Magnetic Stimulation|"In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.~sham stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system."
11335155|NCT03544333|EG000|Reported Event|Real TMS|This group received real TMS.
11335156|NCT03544333|EG001|Reported Event|Sham TMS|This group received sham TMS.
11335157|NCT03544879|BG000|Baseline|Yoga|"The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..~Yoga Intervention: The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses."
11335158|NCT03544879|BG001|Baseline|Health Education|"The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.~The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed ex"
11335159|NCT03544879|BG002|Baseline|Total|Total of all reporting groups
11335160|NCT03544879|FG000|Participant Flow|Yoga|"The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..~Yoga Intervention: The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses."
11335161|NCT03544879|FG001|Participant Flow|Health Education|"The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.~The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed ex"
11335162|NCT03544879|OG000|Outcome|Yoga|"The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..~Yoga Intervention: The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses."
11335163|NCT03544879|OG001|Outcome|Health Education|"The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.~The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed ex"
11335164|NCT03544879|OG000|Outcome|Health Education|The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.
11335493|NCT03551730|EG003|Reported Event|Module 3 (210 mg Andexanet ) Lyophilized|210 mg andexanet IV bolus over 7 minutes (~30 mg/min) 210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335494|NCT03551743|BG000|Baseline|Module 4 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
11335165|NCT03544879|OG001|Outcome|Yoga|"The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..~Yoga Intervention: The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses."
11335166|NCT03544879|EG000|Reported Event|Yoga|"The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..~Yoga Intervention: The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses."
11335167|NCT03544879|EG001|Reported Event|Health Education|"The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.~The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed ex"
11335168|NCT03545165|BG000|Baseline|Cohort 1|Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
11335169|NCT03545165|FG000|Participant Flow|Cohort 1|Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
11335170|NCT03545165|OG000|Outcome|Cohort 1|Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
11335171|NCT03545165|EG000|Reported Event|Cohort 1|Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
11335172|NCT03545412|BG000|Baseline|Ultherapy Treatment|Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
11335173|NCT03545412|FG000|Participant Flow|Ultherapy Treatment|Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
11335174|NCT03545412|OG000|Outcome|Ultherapy Treatment|Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
11335175|NCT03545412|EG000|Reported Event|Ultherapy Treatment|Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.
11335176|NCT03545503|BG000|Baseline|Etomidate|"Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push~Etomidate: Etomidate will be administered as the sedative for RSI on even days"
11335177|NCT03545503|BG001|Baseline|Ketamine|"Ketamine will be dosed once at a standard 2 mg/kg via IV Push~Ketamine: Ketamine will be administered as the sedative for RSI on odd days"
11335178|NCT03545503|BG002|Baseline|Total|Total of all reporting groups
11335179|NCT03545503|FG000|Participant Flow|Etomidate|"Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push~Etomidate: Etomidate will be administered as the sedative for RSI on even days"
11335180|NCT03545503|FG001|Participant Flow|Ketamine|"Ketamine will be dosed once at a standard 2 mg/kg via IV Push~Ketamine: Ketamine will be administered as the sedative for RSI on odd days"
11335181|NCT03545503|OG000|Outcome|Etomidate|Participants randomized to receive etomidate
11335182|NCT03545503|OG001|Outcome|Ketamine|Participants randomized to receive ketamine
11335183|NCT03545503|EG000|Reported Event|Etomidate|Participants receiving etomidate
11335184|NCT03545503|EG001|Reported Event|Ketamine|Participants receiving ketamine
11335185|NCT03545893|BG000|Baseline|Ibuprofen|Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
11335186|NCT03545893|BG001|Baseline|Ibuprofen + Oxycodone|"Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.~OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain."
11335187|NCT03545893|BG002|Baseline|Total|Total of all reporting groups
11335188|NCT03545893|FG000|Participant Flow|Ibuprofen|Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
11335189|NCT03545893|FG001|Participant Flow|Ibuprofen + Oxycodone|"Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.~OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain."
11335190|NCT03545893|OG000|Outcome|Ibuprofen|Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
11335191|NCT03545893|OG001|Outcome|Ibuprofen + Oxycodone|"Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.~OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain."
11335192|NCT03545893|EG000|Reported Event|Ibuprofen|Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
11335193|NCT03545893|EG001|Reported Event|Ibuprofen + Oxycodone|"Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.~OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain."
11335194|NCT03545984|BG000|Baseline|Simulation-based Training|"The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin.~Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions"
11335195|NCT03545984|BG001|Baseline|Problem Based Learning|"The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation.~interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation"
11335196|NCT03545984|BG002|Baseline|Total|Total of all reporting groups
11335197|NCT03545984|FG000|Participant Flow|Simulation-based Training|"The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin.~Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions"
11335198|NCT03545984|FG001|Participant Flow|Problem Based Learning|"The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation.~interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation"
11335199|NCT03545984|OG000|Outcome|Simulation-based Training|"The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin.~Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions"
11335200|NCT03545984|OG001|Outcome|Problem Based Learning|"The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation.~interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation"
11335201|NCT03545984|EG000|Reported Event|Simulation-based Training|"The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin.~Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions"
11335202|NCT03545984|EG001|Reported Event|Problem Based Learning|"The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation.~interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation"
11335203|NCT03546270|BG000|Baseline|Swimming|"Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate~Swimming: This group completed 20-weeks of swimming"
11335204|NCT03546270|BG001|Baseline|Control|Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
11335205|NCT03546270|BG002|Baseline|Total|Total of all reporting groups
11335206|NCT03546270|FG000|Participant Flow|Swimming|"Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate~Swimming: This group completed 20-weeks of swimming"
11335207|NCT03546270|FG001|Participant Flow|Control|Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
11335495|NCT03551743|BG001|Baseline|Module 4 (600mg)|600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
11335208|NCT03546270|OG000|Outcome|Swimming|"Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate~Swimming: This group completed 20-weeks of swimming"
11335209|NCT03546270|OG001|Outcome|Control|Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
11335210|NCT03546270|EG000|Reported Event|Swimming|"Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate~Swimming: This group completed 20-weeks of swimming"
11335211|NCT03546270|EG001|Reported Event|Control|Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
11335212|NCT03546491|BG000|Baseline|Overall Study|This was a controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study.
11335213|NCT03546491|FG000|Participant Flow|Overall Study|This was a single center, controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study. Each participant received Test product 1 (0.4% stannous fluoride preventive gel), and Test product 2 (marketed 0.243% sodium fluoride toothpaste). All subjects saw each test product at least 1 time, for the third period, each subject saw either Test product 1 or Test product 2 for a second time.
11335214|NCT03546491|OG000|Outcome|Preventive Gel|"0.4% stannous fluoride~Preventive Gel: 0.4% Stannous Fluoride"
11335215|NCT03546491|OG001|Outcome|Marketed Control|"0.243 % Sodium Fluoride~Marketed Control: 0.243% Sodium Fluoride"
11335216|NCT03546491|OG000|Outcome|Preventive Gel|0.4% stannous fluoride Preventive Gel
11335217|NCT03546491|OG001|Outcome|Marketed Control|0.243% sodium fluoride
11335218|NCT03546491|OG000|Outcome|Preventive Gel|0.4% stannous fluoride preventive gel
11335219|NCT03546491|OG001|Outcome|Marketed Control|0.243% Sodium fluoride toothpaste
11335220|NCT03546491|EG000|Reported Event|Preventive Gel|0.4% stannous fluoride preventive gel
11335221|NCT03546491|EG001|Reported Event|Marketed Control|0.243% sodium fluoride toothpaste
11335222|NCT03546621|BG000|Baseline|Arm A|"Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex B: 2 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335223|NCT03546621|BG001|Baseline|Arm B|"Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 5 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335224|NCT03546621|BG002|Baseline|Arm C|"Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 10 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335225|NCT03546621|BG003|Baseline|Arm D|"tenofovir treatment for 48 weeks~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335226|NCT03546621|BG004|Baseline|Total|Total of all reporting groups
11335227|NCT03546621|FG000|Participant Flow|Arm A|"Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex B: 2 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335228|NCT03546621|FG001|Participant Flow|Arm B|"Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 5 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335229|NCT03546621|FG002|Participant Flow|Arm C|"Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 10 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335230|NCT03546621|FG003|Participant Flow|Arm D|"tenofovir treatment for 48 weeks~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335231|NCT03546621|OG000|Outcome|Arm A|"Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex B: 2 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335232|NCT03546621|OG001|Outcome|Arm B|"Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 5 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335233|NCT03546621|OG002|Outcome|Arm C|"Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 10 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335234|NCT03546621|OG003|Outcome|Arm D|"tenofovir treatment for 48 weeks~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335496|NCT03551743|BG002|Baseline|Module 4 (800 mg Bolus + 480 mg Infusion)|800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
11335235|NCT03546621|EG000|Reported Event|Arm A|"Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex B: 2 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335236|NCT03546621|EG001|Reported Event|Arm B|"Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 5 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335237|NCT03546621|EG002|Reported Event|Arm C|"Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.~Myrcludex-B: 10 mg, once daily, subcutaneously~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335238|NCT03546621|EG003|Reported Event|Arm D|"tenofovir treatment for 48 weeks~Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg"
11335239|NCT03546647|BG000|Baseline|All Study Participants|"Toric group:~Participants who received Toric contact lenses first and spherical lenses after 10 days~Sphere group:~Participants who received spherical contact lenses first and Toric lenses after 10 days"
11335240|NCT03546647|FG000|Participant Flow|Toric, Then Sphere|Participants who received Toric contact lenses first and spherical lenses after 10 days
11335241|NCT03546647|FG001|Participant Flow|Sphere, Then Toric|Participants who received Sphere contact lenses first and Toric lenses after 10 days
11335242|NCT03546647|OG000|Outcome|Toric|Participants who wore Toric contact lenses for 10 days
11335243|NCT03546647|OG001|Outcome|Sphere|Participants who wore Spherical contact lenses for 10 days
11335244|NCT03546647|EG000|Reported Event|Toric|"Soft toric contact lens~Dailies Aqua Comfort Plus Toric: Daily disposable soft toric contact lens"
11335245|NCT03546647|EG001|Reported Event|Sphere|"Soft sphere contact lens~Dailies Aqua Comfort Plus Sphere: Daily disposable soft spherical contact lens"
11335246|NCT03546816|BG000|Baseline|Serlopitant 5 mg|Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335247|NCT03546816|BG001|Baseline|Placebo|Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335248|NCT03546816|BG002|Baseline|Total|Total of all reporting groups
11335249|NCT03546816|FG000|Participant Flow|Serlopitant 5 mg|Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335250|NCT03546816|FG001|Participant Flow|Placebo|Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335251|NCT03546816|OG000|Outcome|Serlopitant 5 mg|Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335252|NCT03546816|OG001|Outcome|Placebo|Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335253|NCT03546816|OG000|Outcome|Serlopitant 5 mg|Randomized subjects received Serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day on an outpatient basis.
11335254|NCT03546816|OG001|Outcome|Placebo|Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day on an outpatient basis.
11335255|NCT03546816|EG000|Reported Event|Serlopitant 5 mg|Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335256|NCT03546816|EG001|Reported Event|Placebo|Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day.
11335257|NCT03546842|BG000|Baseline|9vHPV Vaccine|Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
11335258|NCT03546842|FG000|Participant Flow|9vHPV Vaccine|Participants received a single 0.5-mL intramuscular injection of the 9-valent human papillomavirus (9vHPV) vaccine at Day 1, Month 2, and Month 6
11335259|NCT03546842|OG000|Outcome|9vHPV Vaccine|Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
11335260|NCT03546842|EG000|Reported Event|9vHPV Vaccine|Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
11335261|NCT03547154|BG000|Baseline|INTRON A (Interferon Alfa-2b)|Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335262|NCT03547154|BG001|Baseline|PEG Intron (Pegylated Interferon Alfa-2b)|Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335263|NCT03547154|BG002|Baseline|Total|Total of all reporting groups
11335264|NCT03547154|FG000|Participant Flow|INTRON A (Interferon Alfa-2b)|Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.
11335265|NCT03547154|FG001|Participant Flow|PEG Intron (Pegylated Interferon Alfa-2b)|Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335497|NCT03551743|BG003|Baseline|Module 4 (800 mg)|800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
11335266|NCT03547154|OG000|Outcome|INTRON A (Interferon Alfa-2b)|Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335267|NCT03547154|OG001|Outcome|PEG Intron (Pegylated Interferon Alfa-2b)|Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335268|NCT03547154|EG000|Reported Event|INTRON A, 5 MIU/m^2 Daily|Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.
11335269|NCT03547154|EG001|Reported Event|PEG-Intron, 6.0 mcg/kg Weekly|Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
11335270|NCT03547167|BG000|Baseline|V114|Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335271|NCT03547167|BG001|Baseline|Prevnar 13™|Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335272|NCT03547167|BG002|Baseline|Total|Total of all reporting groups
11335273|NCT03547167|FG000|Participant Flow|V114|Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335274|NCT03547167|FG001|Participant Flow|Prevnar 13™|Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335275|NCT03547167|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335276|NCT03547167|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335277|NCT03547167|OG000|Outcome|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335278|NCT03547167|OG001|Outcome|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335279|NCT03547167|EG000|Reported Event|V114|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335280|NCT03547167|EG001|Reported Event|Prevnar 13™|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335281|NCT03547167|EG002|Reported Event|V114 (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335282|NCT03547167|EG003|Reported Event|Prevnar 13™ (Post-PNEUMOVAX™23)|Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).
11335283|NCT03547531|BG000|Baseline|Natural Tooth Brushing Method|"Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.~Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method."
11335284|NCT03547531|BG001|Baseline|Modified Circular Tooth Brushing Method|"Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.~Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches."
11335285|NCT03547531|BG002|Baseline|Total|Total of all reporting groups
11335286|NCT03547531|FG000|Participant Flow|Natural Tooth Brushing Method|"Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.~Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method."
11335287|NCT03547531|FG001|Participant Flow|Modified Circular Tooth Brushing Method|"Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.~Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches."
11335288|NCT03547531|OG000|Outcome|Natural Tooth Brushing Method|"Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.~Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method."
11335498|NCT03551743|BG004|Baseline|Total|Total of all reporting groups
11335499|NCT03551743|FG000|Participant Flow|Module 4 Placebo|Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
11335289|NCT03547531|OG001|Outcome|Modified Circular Tooth Brushing Method|"Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.~Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches."
11335290|NCT03547531|EG000|Reported Event|Natural Tooth Brushing Method|"Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.~Natural Tooth Brushing Method: Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method."
11335291|NCT03547531|EG001|Reported Event|Modified Circular Tooth Brushing Method|"Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.~Modified Circular Tooth Brushing Method: Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches."
11335292|NCT03547583|BG000|Baseline|Vericiguat up to 10 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
11335293|NCT03547583|BG001|Baseline|Vericiguat up to 15 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
11335294|NCT03547583|BG002|Baseline|Placebo|Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
11335295|NCT03547583|BG003|Baseline|Total|Total of all reporting groups
11335296|NCT03547583|FG000|Participant Flow|Vericiguat up to 10 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
11335297|NCT03547583|FG001|Participant Flow|Vericiguat up to 15 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
11335298|NCT03547583|FG002|Participant Flow|Placebo|Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
10843399|NCT00254293|OG000|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
11335299|NCT03547583|OG000|Outcome|Vericiguat up to 10 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
11335300|NCT03547583|OG001|Outcome|Vericiguat up to 15 mg|Participants received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
11335301|NCT03547583|OG002|Outcome|Placebo|Participants received placebo once daily and sham up-titration at weeks 2, 4, and 6.
11335302|NCT03547583|OG000|Outcome|Vericiguat up to 10 mg|Participants will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
11335303|NCT03547583|OG001|Outcome|Vericiguat up to 15 mg|Participants will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6 week.
11335304|NCT03547583|OG002|Outcome|Placebo|Participants will receive placebo once daily and sham up-titration at weeks 2, 4, and 6.
11335305|NCT03547583|EG000|Reported Event|Vericiguat up to 10 mg|Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
11335306|NCT03547583|EG001|Reported Event|Vericiguat up to 15 mg|Subjects received vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
11335307|NCT03547583|EG002|Reported Event|Placebo|Subjects received placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
11335308|NCT03547635|BG000|Baseline|AMNIOEXCEL Plus Amniotic Membrane|AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
11335309|NCT03547635|BG001|Baseline|A Marketed Comparator|A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
11335310|NCT03547635|BG002|Baseline|Standard of Care|"Standard of Care: • Coban™~Conforming gauze~Optifoam® non-adhesive dressing~Cotton Gauze~Normal saline (liquid or gel)~Non-adhering dressings~Steristrips~An offloading boot (Pneumatic Short Leg Walker), as appropriate"
11335311|NCT03547635|BG003|Baseline|Total|Total of all reporting groups
11335312|NCT03547635|FG000|Participant Flow|AMNIOEXCEL Plus Amniotic Membrane|AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
11335313|NCT03547635|FG001|Participant Flow|A Marketed Comparator|A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
11335314|NCT03547635|FG002|Participant Flow|Standard of Care|"Standard of Care: • Coban™~Conforming gauze~Optifoam® non-adhesive dressing~Cotton Gauze~Normal saline (liquid or gel)~Non-adhering dressings~Steristrips~An offloading boot (Pneumatic Short Leg Walker), as appropriate"
11335315|NCT03547635|OG000|Outcome|AMNIOEXCEL Plus Amniotic Membrane|AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
11335316|NCT03547635|OG001|Outcome|A Marketed Comparator|A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
11335317|NCT03547635|OG002|Outcome|Standard of Care|"Standard of Care: • Coban™~Conforming gauze~Optifoam® non-adhesive dressing~Cotton Gauze~Normal saline (liquid or gel)~Non-adhering dressings~Steristrips~An offloading boot (Pneumatic Short Leg Walker), as appropriate"
11335318|NCT03547635|EG000|Reported Event|AMNIOEXCEL Plus Amniotic Membrane|AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
11335319|NCT03547635|EG001|Reported Event|A Marketed Comparator|A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
11335320|NCT03547635|EG002|Reported Event|Standard of Care|"Standard of Care: • Coban™~Conforming gauze~Optifoam® non-adhesive dressing~Cotton Gauze~Normal saline (liquid or gel)~Non-adhering dressings~Steristrips~An offloading boot (Pneumatic Short Leg Walker), as appropriate"
11335321|NCT03547687|BG000|Baseline|Electrical Stimulation Treatment|"Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.~Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each"
11335500|NCT03551743|FG001|Participant Flow|Module 4 (600mg)|600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
10843400|NCT00254293|OG001|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
11335322|NCT03547687|FG000|Participant Flow|Electrical Stimulation Treatment|"Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.~Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each"
11335323|NCT03547687|OG000|Outcome|Electrical Stimulation Treatment|"Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.~Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device or a Vectra® Neo Clinical Therapy System will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300-450 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each"
11335324|NCT03547687|EG000|Reported Event|Electrical Stimulation Treatment|"Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.~Electrical Stimulation Treatment: An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 5 seconds on, 15 seconds off Ramp up and down time: 2 seconds each"
11335325|NCT03548337|BG000|Baseline|13vPnC: Multi-dose Vial (With Preservative)|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335326|NCT03548337|BG001|Baseline|13vPnC: Single-dose Prefilled Syringe (Without Preservative)|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335327|NCT03548337|BG002|Baseline|Total|Total of all reporting groups
11335328|NCT03548337|FG000|Participant Flow|13vPnC: Multi-dose Vial (With Preservative)|Infant series: participants were randomized to receive a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with preservative 2-phenoxyethanol (2-PE) from a multi-dose vial (MDV), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) diphtheria, tetanus, and pertussis; Haemophilus influenzae type b; and hepatitis B virus (DTP-Hib-HBV) vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335329|NCT03548337|FG001|Participant Flow|13vPnC: Single-dose Prefilled Syringe (Without Preservative)|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose prefilled syringe (PFS), intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335330|NCT03548337|OG000|Outcome|13vPnC: Multi-dose Vial (With Preservative)|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335331|NCT03548337|OG001|Outcome|13vPnC: Single-dose Prefilled Syringe (Without Preservative)|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335332|NCT03548337|OG000|Outcome|13vPnC: Multi-dose Vial (With Preservative)|This arm represents the combined Infant series and Toddler dose. Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335333|NCT03548337|OG001|Outcome|13vPnC: Single-dose Prefilled Syringe (Without Preservative)|This arm represents the combined Infant series and Toddler dose. Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335334|NCT03548337|EG000|Reported Event|13vPnC, MDV With Preservative: Infant Series|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335335|NCT03548337|EG001|Reported Event|13vPnC, PFS Without Preservative: Infant Series|Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) respectively along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335336|NCT03548337|EG002|Reported Event|13vPnC, MDV: Between Infant Series and Toddler Dose|"This arm is created to report the safety data of participants for the duration from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination). It included participants who received any dose of 13vPnC vaccine with preservative 2-PE from a MDV, intramuscularly during infant series and followed up to vaccination in toddler dose."
11335337|NCT03548337|EG003|Reported Event|13vPnC, PFS: Between Infant Series and Toddler Dose|"This arm is created to report the safety data of participants for the duration from 1 month after infant series until the time of toddler dose vaccination (pre-vaccination). It included participants who received any dose of 13vPnC vaccine without preservative 2-PE from a single dose PFS, intramuscularly during infant series and followed up to vaccination in toddler dose."
11335338|NCT03548337|EG004|Reported Event|13vPnC, MDV With Preservative: Toddler Dose|Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from a MDV intramuscularly, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335339|NCT03548337|EG005|Reported Event|13vPnC, PFS Without Preservative: Toddler Dose|Toddler dose followed infant series. Toddler dose: participants were administered a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from a single- dose PFS, at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice).
11335340|NCT03548935|BG000|Baseline|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335341|NCT03548935|BG001|Baseline|Placebo|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335342|NCT03548935|BG002|Baseline|Total|Total of all reporting groups
10843401|NCT00254293|OG002|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
10843402|NCT00254293|OG003|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
10843403|NCT00254293|OG004|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
10843404|NCT00254293|OG000|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10843405|NCT00254293|OG001|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10843406|NCT00254293|OG002|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
10843407|NCT00254293|OG003|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
10843408|NCT00254293|OG004|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
10843409|NCT00254293|OG000|Outcome|75 mg SC Abatacept (Body Weight < 60 kg)|Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843410|NCT00254293|OG001|Outcome|125 mg SC Abatacept (Body Weight <60 to >100 kg)|Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843411|NCT00254293|OG002|Outcome|200 mg SC Abatacept (Body Weight > 100 kg)|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843412|NCT00254293|OG005|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
10843413|NCT00254293|OG000|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
10843414|NCT00254293|OG001|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
10843415|NCT00254293|OG002|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
10843416|NCT00254293|OG003|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
10843417|NCT00254293|OG004|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
10843418|NCT00254293|OG000|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
10843419|NCT00254293|OG001|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
10843420|NCT00254293|OG002|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
10843421|NCT00254293|OG003|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
10843422|NCT00254293|OG004|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
10843423|NCT00254293|OG000|Outcome|All Treated Participants|ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
10843424|NCT00254293|OG000|Outcome|75 mg SC Abatacept|variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843425|NCT00254293|OG001|Outcome|125 mg SC Abatacept|125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843426|NCT00254293|OG002|Outcome|200 mg SC Abatacept|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
10843427|NCT00254293|OG000|Outcome|All Treated Participants|ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
10843428|NCT00254293|OG000|Outcome|SC Abatacept|Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
10843429|NCT00254293|OG000|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
10843430|NCT00254293|OG002|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
10843431|NCT00254293|OG003|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
10843432|NCT00254293|OG005|Outcome|LTE (Variable and Fixed Dosing Abatacept)|Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
10843433|NCT00254293|EG000|Reported Event|Abatacept 1000mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843434|NCT00254293|EG001|Reported Event|Abatacept 1000mg IV/200mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
11335508|NCT03551743|EG001|Reported Event|Module 4 (600mg)|600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
10843435|NCT00254293|EG002|Reported Event|Abatacept 500mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843436|NCT00254293|EG003|Reported Event|Abatacept 500mg IV/75mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10845130|NCT00265317|BG003|Baseline|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
10845131|NCT00265317|BG004|Baseline|Total|Total of all reporting groups
10846532|NCT00277394|OG001|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
10843437|NCT00254293|EG004|Reported Event|Abatacept 750mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843438|NCT00254293|EG005|Reported Event|Abatacept (LT) 125 mg SC|Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
10843439|NCT00254293|EG006|Reported Event|Placebo (ST)|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
10843440|NCT00254397|BG000|Baseline|gp100 + Leuprolide|Group IA: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
10843441|NCT00254397|BG001|Baseline|gp100 - No Leuprolide|Group IB: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
10843442|NCT00254397|BG002|Baseline|gp100 + MAGE-3 + Leuprolide|Group IIA: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
10843443|NCT00254397|BG003|Baseline|gp100 + MAGE-3 - No Leuprolide|Group IIB: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
10843444|NCT00254397|BG004|Baseline|Total|Total of all reporting groups
10843445|NCT00254397|FG000|Participant Flow|gp100 + Leuprolide|Group IA: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
10843446|NCT00254397|FG001|Participant Flow|gp100 - No Leuprolide|Group IB: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
10843447|NCT00254397|FG002|Participant Flow|gp100 + MAGE-3 + Leuprolide|Group IIA: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
10843448|NCT00254397|FG003|Participant Flow|gp100 + MAGE-3 - No Leuprolide|Group IIB: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
10843449|NCT00254397|OG000|Outcome|gp100 + Leuprolide|"Group IA: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).~Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).~GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities."
10843450|NCT00254397|OG001|Outcome|gp100 - No Leuprolide|"Group IB: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide~GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities."
10843451|NCT00254397|OG002|Outcome|gp100 + MAGE-3 + Leuprolide|"Group IIA: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).~Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).~GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.~MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities."
10843452|NCT00254397|OG003|Outcome|gp100 + MAGE-3 - No Leuprolide|"Group IIB: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide~GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.~MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities."
10843453|NCT00254397|OG001|Outcome|gp100 + No Leuprolide|HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities)
10843454|NCT00254397|EG000|Reported Event|gp100, Leuprolide, MAGE-3|HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) with/without Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)); with/without MAGE-3 (1.0 ml subcutaneous injection in extremities)
10843455|NCT00254397|EG001|Reported Event|gp100 + No Leuprolide|HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) without Leuprolide; with/without MAGE-3 (1.0 ml subcutaneous injection in extremities)
10843456|NCT00254410|BG000|Baseline|FCM-R + Pegylated Filgrastim|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
10845132|NCT00265317|FG000|Participant Flow|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
10846533|NCT00277394|EG000|Reported Event|Innohep®|innohep® 175 anti-Xa IU/kg once daily
10843457|NCT00254410|FG000|Participant Flow|FCM-R + Pegylated Filgrastim|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
10843458|NCT00254410|OG000|Outcome|FCM-R + Pegylated Filgrastim|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
10843459|NCT00254410|EG000|Reported Event|FCM-R + Pegylated Filgrastim|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6. Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6. Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6. Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6. Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
10843460|NCT00254462|BG000|Baseline|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
10843461|NCT00254462|BG001|Baseline|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
10843462|NCT00254462|BG002|Baseline|Total|Total of all reporting groups
10843463|NCT00254462|FG000|Participant Flow|Atomoxetine|Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.
10843464|NCT00254462|FG001|Participant Flow|Placebo|Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
10843465|NCT00254462|OG000|Outcome|Atomoxetine|Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.
10843466|NCT00254462|OG001|Outcome|Placebo|Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
10843467|NCT00254462|OG000|Outcome|Atomoxetine|Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.
10843468|NCT00254462|OG001|Outcome|Placebo|Recommended dosing once daily, divided dose at investigator discretion.
10843469|NCT00254462|EG000|Reported Event|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
10843470|NCT00254462|EG001|Reported Event|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
10843471|NCT00254488|BG000|Baseline|Lithium (LI)|Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
10843472|NCT00254488|BG001|Baseline|Divalproex (DV)|Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
10843473|NCT00254488|BG002|Baseline|Total|Total of all reporting groups
10843474|NCT00254488|FG000|Participant Flow|Lithium|"Participants will receive 9 weeks of treatment with lithium~Lithium (LI): The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L)."
10843475|NCT00254488|FG001|Participant Flow|Divalproex|"Participants will receive 9 weeks of treatment with divalproex~Divalproex (DV): Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml)."
10843476|NCT00254488|OG000|Outcome|Lithium (LI)|Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
10843477|NCT00254488|OG001|Outcome|Divalproex (DV)|Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
10843478|NCT00254488|EG000|Reported Event|Lithium (LI)|"Participants will receive 9 weeks of treatment with lithium.~Lithium (LI): The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L)."
10843479|NCT00254488|EG001|Reported Event|Divalproex (DV)|"Participants will receive 9 weeks of treatment with divalproex.~Divalproex (DV): Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml)."
10843480|NCT00254501|BG000|Baseline|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
10843481|NCT00254501|BG001|Baseline|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
10843482|NCT00254501|BG002|Baseline|Total|Total of all reporting groups
10843483|NCT00254501|FG000|Participant Flow|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
10843484|NCT00254501|FG001|Participant Flow|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
10843485|NCT00254501|OG000|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
10846534|NCT00277394|EG001|Reported Event|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
10843486|NCT00254501|OG001|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
10843487|NCT00254501|OG001|Outcome|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
10843488|NCT00254501|OG001|Outcome|EMPOWER|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
10843489|NCT00254501|EG000|Reported Event|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
10843490|NCT00254501|EG001|Reported Event|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
10843491|NCT00254540|BG000|Baseline|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843492|NCT00254540|BG001|Baseline|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843493|NCT00254540|BG002|Baseline|Total|Total of all reporting groups
10843494|NCT00254540|FG000|Participant Flow|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843495|NCT00254540|FG001|Participant Flow|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843496|NCT00254540|OG000|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843497|NCT00254540|OG001|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843498|NCT00254540|OG000|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
10843499|NCT00254540|OG000|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
10843500|NCT00254540|EG000|Reported Event|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
10843501|NCT00254566|BG000|Baseline|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
10843502|NCT00254566|BG001|Baseline|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
10843503|NCT00254566|BG002|Baseline|Total|Total of all reporting groups
10843504|NCT00254566|FG000|Participant Flow|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
10843505|NCT00254566|FG001|Participant Flow|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
10843506|NCT00254566|OG000|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
10843507|NCT00254566|OG001|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
10843508|NCT00254566|EG000|Reported Event|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
10843509|NCT00254566|EG001|Reported Event|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
10843510|NCT00254592|BG000|Baseline|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
10843511|NCT00254592|FG000|Participant Flow|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
10843512|NCT00254592|OG000|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
10843513|NCT00254592|EG000|Reported Event|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
10843514|NCT00254982|BG000|Baseline|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843515|NCT00254982|BG001|Baseline|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843516|NCT00254982|BG002|Baseline|Total|Total of all reporting groups
10843517|NCT00254982|FG000|Participant Flow|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843518|NCT00254982|FG001|Participant Flow|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843519|NCT00254982|OG000|Outcome|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843520|NCT00254982|OG001|Outcome|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
10843521|NCT00254982|EG000|Reported Event|Group 1 (High-need)|
10843522|NCT00254982|EG001|Reported Event|Group 2 (Low-need)|
10843523|NCT00254995|BG000|Baseline|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
10843524|NCT00254995|BG001|Baseline|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
10843525|NCT00254995|BG002|Baseline|Total|Total of all reporting groups
10843526|NCT00254995|FG000|Participant Flow|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice."
10843527|NCT00254995|FG001|Participant Flow|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice."
10843528|NCT00254995|OG000|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
10843529|NCT00254995|OG001|Outcome|Control Group|"The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals."
10843530|NCT00254995|OG001|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
10843531|NCT00254995|OG001|Outcome|Control Group|Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
10843532|NCT00254995|OG001|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
10843533|NCT00254995|EG000|Reported Event|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
10843534|NCT00255008|BG000|Baseline|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
10843535|NCT00255008|BG001|Baseline|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843536|NCT00255008|BG002|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843537|NCT00255008|BG003|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843538|NCT00255008|BG004|Baseline|Total|Total of all reporting groups
10843539|NCT00255008|FG000|Participant Flow|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
10843540|NCT00255008|FG001|Participant Flow|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843541|NCT00255008|FG002|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843542|NCT00255008|FG003|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843543|NCT00255008|OG000|Outcome|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
10843544|NCT00255008|OG001|Outcome|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843545|NCT00255008|OG002|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843546|NCT00255008|OG003|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
10843547|NCT00255008|EG000|Reported Event|Genotype 1 SEA PEG-IFN/RIB 48w|
10843548|NCT00255008|EG001|Reported Event|Genotype 1 Caucasian PEG-IFN/RIB 48w|
10843549|NCT00255008|EG002|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w|
10843550|NCT00255008|EG003|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w|
10843551|NCT00255034|BG000|Baseline|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
10843552|NCT00255034|BG001|Baseline|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
10843553|NCT00255034|BG002|Baseline|Total|Total of all reporting groups
10843554|NCT00255034|FG000|Participant Flow|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
10843555|NCT00255034|FG001|Participant Flow|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
10843556|NCT00255034|OG000|Outcome|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
10843557|NCT00255034|OG001|Outcome|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
10843558|NCT00255034|EG000|Reported Event|24 Weeks of Therapy|
10843559|NCT00255034|EG001|Reported Event|48 Weeks of Therapy|
10843560|NCT00255047|BG000|Baseline|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
10843561|NCT00255047|BG001|Baseline|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843562|NCT00255047|BG002|Baseline|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
10843563|NCT00255047|BG003|Baseline|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843564|NCT00255047|BG004|Baseline|Total|Total of all reporting groups
10843565|NCT00255047|FG000|Participant Flow|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
10843566|NCT00255047|FG001|Participant Flow|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843567|NCT00255047|FG002|Participant Flow|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
10843568|NCT00255047|FG003|Participant Flow|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843569|NCT00255047|OG000|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
10843570|NCT00255047|OG001|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843571|NCT00255047|OG002|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
10843572|NCT00255047|OG003|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843573|NCT00255047|EG000|Reported Event|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
10843574|NCT00255047|EG001|Reported Event|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843575|NCT00255047|EG002|Reported Event|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
10843576|NCT00255047|EG003|Reported Event|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
10843577|NCT00255086|BG000|Baseline|Memantine|"10mg Memantine~Memantine"
10843578|NCT00255086|BG001|Baseline|Control|10mg Placebo pill
10843579|NCT00255086|BG002|Baseline|Total|Total of all reporting groups
10843580|NCT00255086|FG000|Participant Flow|Memantine|"10mg Memantine~Memantine"
10843581|NCT00255086|FG001|Participant Flow|Control|Participants were given Placebo
10843582|NCT00255086|OG000|Outcome|Memantine|"10mg Memantine~Memantine"
10843583|NCT00255086|OG001|Outcome|Control|Participants were given Placebo
10843584|NCT00255086|OG001|Outcome|Control|10mg Placebo pill
10843585|NCT00255086|EG000|Reported Event|Memantine|10mg Memantine
10843586|NCT00255086|EG001|Reported Event|Control|Participants were given matching placebo
10843587|NCT00255125|BG000|Baseline|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843588|NCT00255125|BG001|Baseline|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843589|NCT00255125|BG002|Baseline|Total|Total of all reporting groups
10843590|NCT00255125|FG000|Participant Flow|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843591|NCT00255125|FG001|Participant Flow|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843592|NCT00255125|OG000|Outcome|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843593|NCT00255125|OG001|Outcome|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843594|NCT00255125|OG000|Outcome|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843595|NCT00255125|OG001|Outcome|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843596|NCT00255125|EG000|Reported Event|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843597|NCT00255125|EG001|Reported Event|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
10843598|NCT00255151|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843599|NCT00255151|BG001|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843600|NCT00255151|BG002|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843601|NCT00255151|BG003|Baseline|Total|Total of all reporting groups
10843602|NCT00255151|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843603|NCT00255151|FG001|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843604|NCT00255151|FG002|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843605|NCT00255151|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843606|NCT00255151|OG001|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843607|NCT00255151|OG002|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843608|NCT00255151|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843609|NCT00255151|EG001|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843610|NCT00255151|EG002|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843611|NCT00255164|BG000|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843612|NCT00255164|BG001|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843613|NCT00255164|BG002|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843614|NCT00255164|BG003|Baseline|Total|Total of all reporting groups
10843615|NCT00255164|FG000|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843616|NCT00255164|FG001|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843617|NCT00255164|FG002|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843618|NCT00255164|OG000|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843619|NCT00255164|OG001|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843620|NCT00255164|OG002|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843621|NCT00255164|EG000|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
10843622|NCT00255164|EG001|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
10843623|NCT00255164|EG002|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
10843624|NCT00255177|BG000|Baseline|Placebo|
10843625|NCT00255177|BG001|Baseline|VGX-410 150mg Daily|
10843626|NCT00255177|BG002|Baseline|VGX-410 300mg Daily|
10843627|NCT00255177|BG003|Baseline|VGX-410 300mg Twice Daily|
10843628|NCT00255177|BG004|Baseline|Total|Total of all reporting groups
10843629|NCT00255177|FG000|Participant Flow|Placebo|
10843630|NCT00255177|FG001|Participant Flow|VGX-410 150mg Daily|
10843631|NCT00255177|FG002|Participant Flow|VGX-410 300mg Daily|
10843632|NCT00255177|FG003|Participant Flow|VGX-410 300mg Twice Daily|
10843633|NCT00255177|OG000|Outcome|Placebo|
10843634|NCT00255177|OG001|Outcome|VGX-410 150mg Daily|
10843635|NCT00255177|OG002|Outcome|VGX-410 300mg Daily|
10843636|NCT00255177|OG003|Outcome|VGX-410 300mg Twice Daily|
10843637|NCT00255177|EG000|Reported Event|Placebo|
10843638|NCT00255177|EG001|Reported Event|VGX-410 150mg Daily|
10843639|NCT00255177|EG002|Reported Event|VGX-410 300mg Daily|
10843640|NCT00255177|EG003|Reported Event|VGX-410 300mg Twice Daily|
10843641|NCT00255190|BG000|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
10843642|NCT00255190|BG001|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
10843643|NCT00255190|BG002|Baseline|Total|Total of all reporting groups
10843644|NCT00255190|FG000|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
10843645|NCT00255190|FG001|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
10843646|NCT00255190|OG000|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
10843647|NCT00255190|OG001|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
10843648|NCT00255190|EG000|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
10843649|NCT00255190|EG001|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
10843650|NCT00255346|BG000|Baseline|Acute Myeloid Leukemia (AML)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843651|NCT00255346|BG001|Baseline|MDS/CMML|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843652|NCT00255346|BG002|Baseline|HES/CEL|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843653|NCT00255346|BG003|Baseline|Primary Myelofibrosis (PMF)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843654|NCT00255346|BG004|Baseline|Systemic Mastocytosis (SM)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843655|NCT00255346|BG005|Baseline|Total|Total of all reporting groups
10843656|NCT00255346|FG000|Participant Flow|Acute Myeloid Leukemia (AML)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843657|NCT00255346|FG001|Participant Flow|MDS/CMML|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843658|NCT00255346|FG002|Participant Flow|HES/CEL|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843659|NCT00255346|FG003|Participant Flow|Primary Myelofibrosis (PMF)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843660|NCT00255346|FG004|Participant Flow|Systemic Mastocytosis (SM)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843661|NCT00255346|OG000|Outcome|Acute Myeloid Leukemia (AML)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843662|NCT00255346|OG001|Outcome|MDS/CMML|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843663|NCT00255346|OG002|Outcome|HES/CEL|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843664|NCT00255346|OG003|Outcome|Primary Myelofibrosis (PMF)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843665|NCT00255346|OG004|Outcome|Systemic Mastocytosis (SM)|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843666|NCT00255346|EG000|Reported Event|Dasatinib All Patient Groups|"Dasatinib 70 mg orally twice daily.~Dasatinib (BMS-354825): 70 mg orally twice daily"
10843667|NCT00255684|BG000|Baseline|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
10843668|NCT00255684|FG000|Participant Flow|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
10843669|NCT00255684|OG000|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
10843670|NCT00255684|EG000|Reported Event|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
10843671|NCT00255723|BG000|Baseline|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
10843672|NCT00255723|BG001|Baseline|Arm B|Augmented ICE x 2 cycles (2 risk factors)
10843673|NCT00255723|BG002|Baseline|Total|Total of all reporting groups
10843674|NCT00255723|FG000|Participant Flow|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
10843675|NCT00255723|FG001|Participant Flow|Arm B|Augmented ICE x 2 cycles (2 risk factors)
10843676|NCT00255723|OG000|Outcome|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
10843677|NCT00255723|OG001|Outcome|Arm B|Augmented ICE x 2 cycles (2 risk factors)
10843678|NCT00255723|EG000|Reported Event|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
10843679|NCT00255723|EG001|Reported Event|Arm B|Augmented ICE x 2 cycles (2 risk factors)
10843680|NCT00255801|BG000|Baseline|Doxil and Targretin® (Bexarotene)|Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
10843681|NCT00255801|FG000|Participant Flow|Doxil and Targretin® (Bexarotene)|Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
10843682|NCT00255801|OG000|Outcome|Doxil and Targretin® (Bexarotene)|Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
10843683|NCT00255801|EG000|Reported Event|Doxil and Targretin® (Bexarotene)|Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
10843684|NCT00255840|BG000|Baseline|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843685|NCT00255840|BG001|Baseline|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843686|NCT00255840|BG002|Baseline|Total|Total of all reporting groups
10843687|NCT00255840|FG000|Participant Flow|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843688|NCT00255840|FG001|Participant Flow|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843689|NCT00255840|OG000|Outcome|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843690|NCT00255840|OG001|Outcome|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10845133|NCT00265317|FG001|Participant Flow|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
10843691|NCT00255840|EG000|Reported Event|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843692|NCT00255840|EG001|Reported Event|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
10843693|NCT00255944|BG000|Baseline|Intervention|"Participants will receive internet-based messages from the Youthnet program~Youthnet Internet-based program: Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness."
10843694|NCT00255944|BG001|Baseline|Control|"Participants will receive internet-based messages from the control program~Control Internet based program: The control program will deliver standard STD/HIV prevention messages."
10843695|NCT00255944|BG002|Baseline|Total|Total of all reporting groups
10843696|NCT00255944|FG000|Participant Flow|Intervention Arm--exposure to Intervention on Facebook|"Participants will receive internet-based messages from the Youthnet program~Youthnet Internet-based program: Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness."
10843697|NCT00255944|FG001|Participant Flow|Control Arm--exposure to Control Content on Facebook|"Participants will receive internet-based messages from the control program~Control Internet based program: The control program will deliver standard STD/HIV prevention messages."
10843698|NCT00255944|OG000|Outcome|Intervention Arm--exposure to Facebook|"Participants will receive internet-based messages from the Youthnet program~Youthnet Internet-based program: Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness."
10843699|NCT00255944|OG001|Outcome|Control Arm--exposure to Control Content on Facebook|"Participants will receive internet-based messages from the control program~Control Internet based program: The control program will deliver standard STD/HIV prevention messages."
10843700|NCT00255944|EG000|Reported Event|Intervention Arm--exposure to Intervention on Facebook|"Participants will receive internet-based messages from the Youthnet program~Youthnet Internet-based program: Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness."
10843701|NCT00255944|EG001|Reported Event|Control Arm--exposure to Control Content on Facebook|"Participants will receive internet-based messages from the control program~Control Internet based program: The control program will deliver standard STD/HIV prevention messages."
10843702|NCT00255970|BG000|Baseline|Regenafil|Regenafil graft
10843703|NCT00255970|BG001|Baseline|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
10843704|NCT00255970|BG002|Baseline|Total|Total of all reporting groups
10843705|NCT00255970|FG000|Participant Flow|Regenafil|Regenafil graft
10843706|NCT00255970|FG001|Participant Flow|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
10843707|NCT00255970|OG000|Outcome|Regenafil|Regenafil graft
10843708|NCT00255970|OG001|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
10843709|NCT00255970|EG000|Reported Event|Regenafil|Regenafil graft
10843710|NCT00255970|EG001|Reported Event|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
10843711|NCT00256126|BG000|Baseline|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
10843712|NCT00256126|BG001|Baseline|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
10843713|NCT00256126|BG002|Baseline|Total|Total of all reporting groups
10843714|NCT00256126|FG000|Participant Flow|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
10843715|NCT00256126|FG001|Participant Flow|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
10843716|NCT00256126|OG000|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
10843717|NCT00256126|OG001|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
10843718|NCT00256126|EG000|Reported Event|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
10843719|NCT00256126|EG001|Reported Event|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
10843720|NCT00256204|BG000|Baseline|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843721|NCT00256204|BG001|Baseline|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843722|NCT00256204|BG002|Baseline|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843723|NCT00256204|BG003|Baseline|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843724|NCT00256204|BG004|Baseline|Total|Total of all reporting groups
10843725|NCT00256204|FG000|Participant Flow|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843726|NCT00256204|FG001|Participant Flow|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843727|NCT00256204|FG002|Participant Flow|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843728|NCT00256204|FG003|Participant Flow|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843729|NCT00256204|OG000|Outcome|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843730|NCT00256204|OG001|Outcome|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843731|NCT00256204|OG002|Outcome|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
10843732|NCT00256204|OG003|Outcome|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
10843733|NCT00256204|OG000|Outcome|1mg Delayed Start|+ 2 mg Delayed Start: 36 week combined placebo group.
10843734|NCT00256204|OG001|Outcome|1mg Early Start|1mg early start active treatment arm (72 weeks active)
10843735|NCT00256204|OG002|Outcome|2mg Early Start|2mg early start active treatment arm (72 weeks active)
10843736|NCT00256204|OG003|Outcome|2mg Delayed Start|+1mg Delayed Start: see 1st column
10843737|NCT00256204|EG000|Reported Event|Placebo Combined Group|1mg & 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.
10843738|NCT00256204|EG001|Reported Event|1mg Active Treatment|1mg Active & 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)
10843739|NCT00256204|EG002|Reported Event|2mg Active Treatment|2mg Active & 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
10843740|NCT00256217|BG000|Baseline|Anastrozole|Anastrozole: 1 mg. oral every day for 2 - 4 weeks
10843741|NCT00256217|FG000|Participant Flow|Anastrozole|Anastrozole: 1 mg. oral every day for 2 - 4 weeks
10843742|NCT00256217|OG000|Outcome|Anastrozole|Anastrozole: 1 mg. oral every day for 2 - 4 weeks
10843743|NCT00256217|EG000|Reported Event|Anastrozole|Anastrozole: 1 mg. oral every day for 2 - 4 weeks
10843744|NCT00256243|BG000|Baseline|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
10843745|NCT00256243|FG000|Participant Flow|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
10843746|NCT00256243|OG000|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
10843747|NCT00256243|OG000|Outcome|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
10843748|NCT00256243|EG000|Reported Event|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
10843749|NCT00256282|BG000|Baseline|Docetaxel and Vinorelbine Plus Sargramostim|The DVS regimen consisted of docetaxel 40 mg/m2 IV over 1 hour, vinorelbine 30 mg/m2 IV over 6 to 10 minutes on day 1, every 14 days, and GM-CSF, 250 mg/m2 SC on days 2 to 12. Patients received a cycle of this regimen every two weeks.
10845134|NCT00265317|FG002|Participant Flow|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
10843750|NCT00256282|FG000|Participant Flow|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
10843751|NCT00256282|OG000|Outcome|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
10843752|NCT00256282|EG000|Reported Event|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
10843753|NCT00256308|BG000|Baseline|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
10843754|NCT00256308|FG000|Participant Flow|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
10843755|NCT00256308|OG000|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
10843756|NCT00256308|EG000|Reported Event|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
10843757|NCT00256451|BG000|Baseline|Overall Study Population|all participants in the cross over study
10843758|NCT00256451|FG000|Participant Flow|Ntx-Alc; Placebo-Sham; Ntx-Sham; Placebo-Alc|"Session1: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session2:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session3: sham alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session4: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843759|NCT00256451|FG001|Participant Flow|Ntx-Sham; Ntx-Alc; Placebo-Alc; Placebo-Sham|"Session1: sham alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session2: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session3: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session4: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol"
10843760|NCT00256451|FG002|Participant Flow|Placebo-Alc; Ntx-Sham; Placebo-Sham; Ntx-Alc|"Session1: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session2: sham alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session3:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session4: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843761|NCT00256451|FG003|Participant Flow|Placebo-Sham; Placebo-Alc; Ntx-Alc; Ntx-Sham|"Session1: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session2: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session3: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.~Session4: sham alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol"
10843762|NCT00256451|OG000|Outcome|ALC and NAL|"alcohol and active naltrexone~Naltrexone: 50 mg/day for two days prior to the alcohol challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843763|NCT00256451|OG001|Outcome|Placebo ALC and NAL|"sham alcohol and active naltrexone~Naltrexone: 50 mg/day for two days prior to the alcohol challenge session~Sham alcohol: non-alcoholic placebo alcohol"
10843764|NCT00256451|OG002|Outcome|Placebo Pill and ALC|"placebo naltrexone and alcohol~placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843765|NCT00256451|OG003|Outcome|Placebo Pill and Placebo ALC|"placebo naltrexone and placebo (non-alcoholic) alcohol~placebo: placebo pills~Sham alcohol: non-alcoholic placebo alcohol"
10843766|NCT00256451|EG000|Reported Event|ALC and NAL|"alcohol and active naltrexone~Naltrexone: 50 mg/day for two days prior to the alcohol challenge session~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843767|NCT00256451|EG001|Reported Event|Placebo ALC and NAL|"sham alcohol and active naltrexone~Naltrexone: 50 mg/day for two days prior to the alcohol challenge session~Sham alcohol: non-alcoholic placebo alcohol"
10843768|NCT00256451|EG002|Reported Event|Placebo Pill and ALC|"placebo naltrexone and alcohol~placebo: placebo pills~alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice."
10843769|NCT00256451|EG003|Reported Event|Placebo Pill and Placebo ALC|"placebo naltrexone and placebo (non-alcoholic) alcohol~placebo: placebo pills~Sham alcohol: non-alcoholic placebo alcohol"
10843770|NCT00256698|BG000|Baseline|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
10843771|NCT00256698|BG001|Baseline|Anastrozole|Anastrozole 1 mg
10843772|NCT00256698|BG002|Baseline|Total|Total of all reporting groups
10843773|NCT00256698|FG000|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
10843774|NCT00256698|FG001|Participant Flow|Anastrozole|Anastrozole 1 mg
10843775|NCT00256698|OG000|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
10843776|NCT00256698|OG001|Outcome|Anastrozole|Anastrozole 1 mg
10843777|NCT00256698|EG000|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
10843778|NCT00256698|EG001|Reported Event|Anastrozole|Anastrozole 1 mg
10843779|NCT00256724|BG000|Baseline|Sham ITD|sham Impedance Threshold Device
10843780|NCT00256724|BG001|Baseline|Active ITD|active impedance threshold device
10843781|NCT00256724|BG002|Baseline|Total|Total of all reporting groups
10843782|NCT00256724|FG000|Participant Flow|Sham ITD|sham Impedance Threshold Device
10843783|NCT00256724|FG001|Participant Flow|Active ITD|active impedance threshold device
10843784|NCT00256724|OG000|Outcome|Sham ITD|sham Impedance Threshold Device
10843785|NCT00256724|OG001|Outcome|Active ITD|active impedance threshold device
10843786|NCT00256724|EG000|Reported Event|Sham ITD|sham Impedance Threshold Device
10843787|NCT00256724|EG001|Reported Event|Active ITD|active impedance threshold device
10843788|NCT00256750|BG000|Baseline|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
10843789|NCT00256750|BG001|Baseline|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843790|NCT00256750|BG002|Baseline|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843791|NCT00256750|BG003|Baseline|Total|Total of all reporting groups
10843792|NCT00256750|FG000|Participant Flow|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
10843793|NCT00256750|FG001|Participant Flow|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843794|NCT00256750|FG002|Participant Flow|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843795|NCT00256750|OG000|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
10843796|NCT00256750|OG001|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843797|NCT00256750|OG002|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843798|NCT00256750|OG002|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843799|NCT00256750|EG000|Reported Event|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
10843800|NCT00256750|EG001|Reported Event|Belatacept - LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843801|NCT00256750|EG002|Reported Event|Belatacept - MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
10843802|NCT00256776|BG000|Baseline|Thal + Dex + Velcade|"Velcade (Bortezomib)~Thalidomide~Dexamethasone~Allocated to treatment (n=135) Received allocated treatment (n=135)"
10843803|NCT00256776|BG001|Baseline|Thal + Dex|"Standard treatment~Thalidomide~Dexamethasone~Allocated to treatment (n=134) Received allocated treatment (n=134)"
10843804|NCT00256776|BG002|Baseline|Total|Total of all reporting groups
10843805|NCT00256776|FG000|Participant Flow|Thal + Dex + Velcade|"Velcade (Bortezomib)~Thalidomide~Dexamethasone~Allocated to treatment (n=135) Received allocated treatment (n=135)"
10843806|NCT00256776|FG001|Participant Flow|Thal + Dex|"Standard treatment~Thalidomide~Dexamethasone~Allocated to treatment (n=134) Received allocated treatment (n=134)"
10843807|NCT00256776|OG000|Outcome|Thal + Dex + Velcade|"Velcade (Bortezomib)~Thalidomide~Dexamethasone"
10843808|NCT00256776|OG001|Outcome|Thal + Dex|"Standard treatment~Thalidomide~Dexamethasone"
10843809|NCT00256776|OG000|Outcome|Thal + Dex + Velcade|"Velcade (Bortezomib)~Thalidomide~Dexamethasone~Median time to progression (primary end point): 19.5 months"
10843810|NCT00256776|OG001|Outcome|Thal + Dex|"Standard treatment~Thalidomide~Dexamethasone~Median time to progression (primary end point): 13.8 months"
10843811|NCT00256776|EG000|Reported Event|Thal + Dex + Velcade|"Velcade (Bortezomib)~Thalidomide~Dexamethasone~Allocated to treatment (n=135) Received allocated treatment (n=135)"
10843812|NCT00256776|EG001|Reported Event|Thal + Dex|"Standard treatment~Thalidomide~Dexamethasone~Allocated to treatment (n=134) Received allocated treatment (n=134)"
10843813|NCT00256854|BG000|Baseline|Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
10845135|NCT00265317|FG003|Participant Flow|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
10843814|NCT00256854|BG001|Baseline|Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843815|NCT00256854|BG002|Baseline|Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843816|NCT00256854|BG003|Baseline|Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843817|NCT00256854|BG004|Baseline|Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843818|NCT00256854|BG005|Baseline|Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843819|NCT00256854|BG006|Baseline|Total|Total of all reporting groups
10843820|NCT00256854|FG000|Participant Flow|Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843821|NCT00256854|FG001|Participant Flow|Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843822|NCT00256854|FG002|Participant Flow|Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843823|NCT00256854|FG003|Participant Flow|Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843824|NCT00256854|FG004|Participant Flow|Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843825|NCT00256854|FG005|Participant Flow|Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843826|NCT00256854|OG000|Outcome|Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843827|NCT00256854|OG001|Outcome|Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843828|NCT00256854|OG002|Outcome|Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843829|NCT00256854|OG003|Outcome|Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843830|NCT00256854|OG004|Outcome|Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
10845136|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
10843831|NCT00256854|OG005|Outcome|Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS|Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843832|NCT00256854|OG000|Outcome|Ropinirole Cohort A|It consisted of two dosing groups: A1 and A2. In cohort A1, participants received Placebo in the evening and Ropinirole 1mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort A2, participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843833|NCT00256854|OG001|Outcome|Ropinirole Cohort B|It consisted of two dosing groups: B1 and B2. In cohort B1, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort B2, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843834|NCT00256854|OG002|Outcome|Ropinirole Cohort C|It consisted of two dosing groups: C1 and C2. In cohort C1, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort C2, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843835|NCT00256854|OG000|Outcome|Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR|Participants received Placebo in the evening and Ropinirole 1 milligram (mg) immediate release (IR) at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
10843836|NCT00256854|EG000|Reported Event|Ropinirole Cohort A|It consisted of two dosing groups: A1 and A2. In cohort A1, participants received Placebo in the evening and Ropinirole 1mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort A2, participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843837|NCT00256854|EG001|Reported Event|Ropinirole Cohort B|It consisted of two dosing groups: B1 and B2. In cohort B1, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort B2, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843838|NCT00256854|EG002|Reported Event|Ropinirole Cohort C|It consisted of two dosing groups: C1 and C2. In cohort C1, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort C2, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
10843839|NCT00256867|BG000|Baseline|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843840|NCT00256867|BG001|Baseline|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
10843841|NCT00256867|BG002|Baseline|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843842|NCT00256867|BG003|Baseline|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843843|NCT00256867|BG004|Baseline|RSG 4mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
10843844|NCT00256867|BG005|Baseline|RSG 8mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
10849219|NCT00295009|BG000|Baseline|1-Level Fusion|Circumferential fusion at a single lumbar level.
10843845|NCT00256867|BG006|Baseline|SIMV 40mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
10843846|NCT00256867|BG007|Baseline|SIMV 80mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
10843847|NCT00256867|BG008|Baseline|Total|Total of all reporting groups
10843848|NCT00256867|FG000|Participant Flow|Fixed Dose Combination (FDC) 4/40 Milligram (mg)|Participants received FDC of rosiglitazone (RSG) 4.0 mg and simvastatin (SIMV) 40 mg (FDC 4/40) and matching placebo once a day for 16 weeks. In case of the participants who had Low Density Lipoprotein-cholesterol (LDL-c) > 130 milligram per deciliter (mg/dL) at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg from Week 6 till Week 16.
10843849|NCT00256867|FG001|Participant Flow|FDC 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
10843850|NCT00256867|FG002|Participant Flow|FDC 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg from Week 6 till Week 16.
10843851|NCT00256867|FG003|Participant Flow|FDC 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843852|NCT00256867|FG004|Participant Flow|RSG 4mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
10843853|NCT00256867|FG005|Participant Flow|RSG 8mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
10843854|NCT00256867|FG006|Participant Flow|SIMV 40mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
10843855|NCT00256867|FG007|Participant Flow|SIMV 80mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
10843856|NCT00256867|OG000|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843857|NCT00256867|OG001|Outcome|All RSG Monotherapy Groups|In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.
10843858|NCT00256867|OG000|Outcome|All SIM Monotherapy Groups|In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.
10843859|NCT00256867|OG001|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843860|NCT00256867|OG000|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843861|NCT00256867|OG001|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
10843862|NCT00256867|OG002|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843863|NCT00256867|OG003|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843864|NCT00256867|OG004|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
10843865|NCT00256867|OG005|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
10843866|NCT00256867|OG006|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
10843867|NCT00256867|OG007|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
10843868|NCT00256867|OG000|Outcome|All RSG Monotherapy Groups|In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.
10843869|NCT00256867|EG000|Reported Event|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843870|NCT00256867|EG001|Reported Event|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
10843871|NCT00256867|EG002|Reported Event|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
10843872|NCT00256867|EG003|Reported Event|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
10843873|NCT00256867|EG004|Reported Event|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
10843874|NCT00256867|EG005|Reported Event|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
10843875|NCT00256867|EG006|Reported Event|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
10843876|NCT00256867|EG007|Reported Event|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
10843877|NCT00256984|BG000|Baseline|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
10843878|NCT00256984|FG000|Participant Flow|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
10843879|NCT00256984|OG000|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
10843880|NCT00256984|EG000|Reported Event|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
10843881|NCT00256997|BG000|Baseline|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
10843882|NCT00256997|BG001|Baseline|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion.
10843883|NCT00256997|BG002|Baseline|Total|Total of all reporting groups
10843884|NCT00256997|FG000|Participant Flow|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
10843885|NCT00256997|FG001|Participant Flow|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion.
10843886|NCT00256997|OG000|Outcome|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
10843887|NCT00256997|OG001|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion.
10843888|NCT00256997|OG000|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
10843889|NCT00256997|EG000|Reported Event|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
10843890|NCT00256997|EG001|Reported Event|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion.
10843891|NCT00257010|BG000|Baseline|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
10843892|NCT00257010|FG000|Participant Flow|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
10843893|NCT00257010|OG000|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
10843894|NCT00257010|EG000|Reported Event|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
10843895|NCT00257166|BG000|Baseline|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
10843896|NCT00257166|BG001|Baseline|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
10843897|NCT00257166|BG002|Baseline|Total|Total of all reporting groups
10843898|NCT00257166|FG000|Participant Flow|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
10843899|NCT00257166|FG001|Participant Flow|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
10849220|NCT00295009|BG001|Baseline|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10843900|NCT00257166|OG000|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
10843901|NCT00257166|OG001|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
10843902|NCT00257166|EG000|Reported Event|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
10843903|NCT00257166|EG001|Reported Event|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
10843904|NCT00257192|BG000|Baseline|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843905|NCT00257192|BG001|Baseline|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843906|NCT00257192|BG002|Baseline|Total|Total of all reporting groups
10843907|NCT00257192|FG000|Participant Flow|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843908|NCT00257192|FG001|Participant Flow|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843909|NCT00257192|OG000|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843910|NCT00257192|OG001|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843911|NCT00257192|EG000|Reported Event|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843912|NCT00257192|EG001|Reported Event|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
10843913|NCT00257309|BG000|Baseline|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
10843914|NCT00257309|BG001|Baseline|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
10843915|NCT00257309|BG002|Baseline|Total|Total of all reporting groups
10843916|NCT00257309|FG000|Participant Flow|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
10843917|NCT00257309|FG001|Participant Flow|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
10843918|NCT00257309|OG000|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
10843919|NCT00257309|OG001|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
10849680|NCT00297427|OG001|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
10843920|NCT00257309|EG000|Reported Event|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
10843921|NCT00257309|EG001|Reported Event|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
10843922|NCT00257322|BG000|Baseline|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
10843923|NCT00257322|FG000|Participant Flow|Chemo Therapy and GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
10843924|NCT00257322|OG000|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
10843925|NCT00257322|EG000|Reported Event|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
10843926|NCT00257556|BG000|Baseline|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
10843927|NCT00257556|BG001|Baseline|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
10843928|NCT00257556|BG002|Baseline|Total|Total of all reporting groups
10843929|NCT00257556|FG000|Participant Flow|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
10843930|NCT00257556|FG001|Participant Flow|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
10843931|NCT00257556|OG000|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
10843932|NCT00257556|OG001|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
10843933|NCT00257556|EG000|Reported Event|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
10843934|NCT00257556|EG001|Reported Event|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
10843935|NCT00257608|BG000|Baseline|Bevacizumab + Placebo|Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
10843936|NCT00257608|BG001|Baseline|Bevacizumab + Erlotinib|Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
10843937|NCT00257608|BG002|Baseline|Total|Total of all reporting groups
10843938|NCT00257608|FG000|Participant Flow|Bevacizumab + Chemotherapy|Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
10843939|NCT00257608|FG001|Participant Flow|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
10843940|NCT00257608|FG002|Participant Flow|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
10843941|NCT00257608|OG000|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
10843942|NCT00257608|OG001|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
10843943|NCT00257608|OG000|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
10843944|NCT00257608|OG001|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
10843945|NCT00257608|OG002|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
10843946|NCT00257608|OG003|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
10843947|NCT00257608|OG004|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
10843948|NCT00257608|OG000|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
10843949|NCT00257608|OG000|Outcome|Bevacizumab + Placebo|"Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.~orally daily."
10843950|NCT00257608|EG000|Reported Event|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
10843951|NCT00257608|EG001|Reported Event|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
10843952|NCT00257660|BG000|Baseline|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843953|NCT00257660|BG001|Baseline|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843954|NCT00257660|BG002|Baseline|Total|Total of all reporting groups
10849681|NCT00297427|OG000|Outcome|Acupuncture|Acupuncture: True acupuncture twice weekly for 6 weeks
10843955|NCT00257660|FG000|Participant Flow|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843956|NCT00257660|FG001|Participant Flow|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843957|NCT00257660|OG000|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843958|NCT00257660|OG001|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843959|NCT00257660|EG000|Reported Event|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843960|NCT00257660|EG001|Reported Event|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
10843961|NCT00257686|BG000|Baseline|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
10843962|NCT00257686|BG001|Baseline|Pravastatin 10 mg|Pravastatin 10 mg once daily
10843963|NCT00257686|BG002|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10843964|NCT00257686|BG003|Baseline|Pravastatin 20 mg|Pravastatin 20 mg once daily
10843965|NCT00257686|BG004|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10843966|NCT00257686|BG005|Baseline|Pravastatin 40 mg|Pravastatin 40 mg once daily
10843967|NCT00257686|BG006|Baseline|Total|Total of all reporting groups
10843968|NCT00257686|FG000|Participant Flow|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
10843969|NCT00257686|FG001|Participant Flow|Pravastatin 10 mg|Pravastatin 10 mg once daily
10843970|NCT00257686|FG002|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10843971|NCT00257686|FG003|Participant Flow|Pravastatin 20 mg|Pravastatin 20 mg once daily
10843972|NCT00257686|FG004|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10843973|NCT00257686|FG005|Participant Flow|Pravastatin 40 mg|Pravastatin 40 mg once daily
10843974|NCT00257686|OG000|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
10843975|NCT00257686|OG001|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
10843976|NCT00257686|OG002|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10843977|NCT00257686|OG003|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
10843978|NCT00257686|OG004|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10843979|NCT00257686|OG005|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
10843980|NCT00257686|EG000|Reported Event|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
10843981|NCT00257686|EG001|Reported Event|Pravastatin 10 mg|Pravastatin 10 mg once daily
10843982|NCT00257686|EG002|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
10843983|NCT00257686|EG003|Reported Event|Pravastatin 20 mg|Pravastatin 20 mg once daily
10843984|NCT00257686|EG004|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
10843985|NCT00257686|EG005|Reported Event|Pravastatin 40 mg|Pravastatin 40 mg once daily
10843986|NCT00257725|BG000|Baseline|Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD|Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
10843987|NCT00257725|FG000|Participant Flow|ADHD Treatment Group|Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
10843988|NCT00257725|OG000|Outcome|ADHD Treatment Group|Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD
10843989|NCT00257725|OG000|Outcome|ADHD Treatment Group|Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
10843990|NCT00257725|EG000|Reported Event|Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD|Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
10843991|NCT00257894|BG000|Baseline|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
10843992|NCT00257894|BG001|Baseline|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
10843993|NCT00257894|BG002|Baseline|Total|Total of all reporting groups
10843994|NCT00257894|FG000|Participant Flow|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
10843995|NCT00257894|FG001|Participant Flow|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
10843996|NCT00257894|OG000|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
10843997|NCT00257894|OG001|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
10843998|NCT00257894|EG000|Reported Event|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
10843999|NCT00257894|EG001|Reported Event|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
10844000|NCT00257920|BG000|Baseline|Zemplar First|6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
10844001|NCT00257920|BG001|Baseline|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
10844002|NCT00257920|BG002|Baseline|Total|Total of all reporting groups
10844003|NCT00257920|FG000|Participant Flow|Zemplar First|6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
10844004|NCT00257920|FG001|Participant Flow|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
10844005|NCT00257920|OG000|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
10844006|NCT00257920|OG001|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
10844007|NCT00257920|OG001|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
10844008|NCT00257920|EG000|Reported Event|Zemplar|6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
10844009|NCT00257920|EG001|Reported Event|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
10844010|NCT00257933|BG000|Baseline|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
10844011|NCT00257933|BG001|Baseline|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
10844012|NCT00257933|BG002|Baseline|Total|Total of all reporting groups
10844013|NCT00257933|FG000|Participant Flow|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
10844014|NCT00257933|FG001|Participant Flow|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
10844015|NCT00257933|OG000|Outcome|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
10844016|NCT00257933|OG001|Outcome|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
10844017|NCT00257933|EG000|Reported Event|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
10844018|NCT00257933|EG001|Reported Event|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
10844019|NCT00258011|BG000|Baseline|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
10844020|NCT00258011|FG000|Participant Flow|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
10844021|NCT00258011|OG000|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
10844022|NCT00258011|EG000|Reported Event|Aldurazyme|Aldurazyme
10844023|NCT00258128|BG000|Baseline|Salsalate|Randomized cohorts - Active
10844024|NCT00258128|BG001|Baseline|Placebo|Randomized cohorts - Placebo
10844025|NCT00258128|BG002|Baseline|Total|Total of all reporting groups
10844026|NCT00258128|FG000|Participant Flow|Salsalate 4.0 g/d|
10844027|NCT00258128|FG001|Participant Flow|Placebo|
10844028|NCT00258128|OG000|Outcome|Placebo|Fasting glucose
10844029|NCT00258128|OG001|Outcome|Salsalate|Fasting glucose
10844030|NCT00258128|OG000|Outcome|Salsalate|
10844031|NCT00258128|OG001|Outcome|Placebo|
10844032|NCT00258128|EG000|Reported Event|Salsalate|Active Drug
10844033|NCT00258128|EG001|Reported Event|Placebo|Placebo - for salsalate
10844034|NCT00258154|BG000|Baseline|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
10844035|NCT00258154|BG001|Baseline|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
10844036|NCT00258154|BG002|Baseline|Total|Total of all reporting groups
10844037|NCT00258154|FG000|Participant Flow|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
10844038|NCT00258154|FG001|Participant Flow|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
10844039|NCT00258154|OG000|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
10844040|NCT00258154|OG001|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
10844041|NCT00258154|EG000|Reported Event|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
10844042|NCT00258154|EG001|Reported Event|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
10844043|NCT00258180|BG000|Baseline|Severe Autoimmune Enteropathy|Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.
10844044|NCT00258180|FG000|Participant Flow|Severe Autoimmune Enteropathy|Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.
10844045|NCT00258180|OG000|Outcome|Severe Autoimmune Enteropathy|Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.
10844046|NCT00258180|OG000|Outcome|Severe Autoimmune Enteropathy|"Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover~filgrastim: Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover~cyclophosphamide: Administered IV over 1 hour on days 1-4"
10844047|NCT00258180|EG000|Reported Event|Severe Autoimmune Enteropathy|Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
10844048|NCT00258206|BG000|Baseline|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
10844049|NCT00258206|FG000|Participant Flow|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
10844050|NCT00258206|OG000|Outcome|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
10844051|NCT00258206|EG000|Reported Event|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
10844052|NCT00258310|BG000|Baseline|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
10844053|NCT00258310|FG000|Participant Flow|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
10844054|NCT00258310|OG000|Outcome|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
10844055|NCT00258310|EG000|Reported Event|Capcitabine|"Caoecutabube 1000mg/day for one year~capecitabine~adjuvant therapy"
10844056|NCT00258349|BG000|Baseline|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
10844057|NCT00258349|FG000|Participant Flow|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
10844058|NCT00258349|OG000|Outcome|Vorinostat +Trastuzumab|"Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;~Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle"
10844059|NCT00258349|OG000|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
10844060|NCT00258349|EG000|Reported Event|Vorinostat +Trastuzumab (Phase II)|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
10844061|NCT00258349|EG001|Reported Event|Vorinostat +Trastuzumab (Phase I)|phase I patients for identify maximum tolerated dose
10844062|NCT00258362|BG000|Baseline|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
10844063|NCT00258362|FG000|Participant Flow|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
10844064|NCT00258362|OG000|Outcome|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
10844065|NCT00258362|OG000|Outcome|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
10844066|NCT00258362|EG000|Reported Event|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
10844067|NCT00258440|BG000|Baseline|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
10844068|NCT00258440|BG001|Baseline|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
10844069|NCT00258440|BG002|Baseline|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
10844070|NCT00258440|BG003|Baseline|Total|Total of all reporting groups
10844071|NCT00258440|FG000|Participant Flow|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
10844072|NCT00258440|FG001|Participant Flow|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
10844073|NCT00258440|FG002|Participant Flow|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
10844074|NCT00258440|OG000|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
10844075|NCT00258440|OG001|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
10844076|NCT00258440|OG002|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
10844077|NCT00258440|EG000|Reported Event|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
10844078|NCT00258440|EG001|Reported Event|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
10844079|NCT00258440|EG002|Reported Event|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
10844080|NCT00258674|BG000|Baseline|Claims|Physician feedback of patient process measures using Medicare claims data
10844081|NCT00258674|BG001|Baseline|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
10844082|NCT00258674|BG002|Baseline|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
10844083|NCT00258674|BG003|Baseline|Total|Total of all reporting groups
10844084|NCT00258674|FG000|Participant Flow|Claims|Physician feedback of patient process measures using Medicare claims data
10844085|NCT00258674|FG001|Participant Flow|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
10844086|NCT00258674|FG002|Participant Flow|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
10844087|NCT00258674|OG000|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
10844088|NCT00258674|OG001|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
10844089|NCT00258674|OG002|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
10844090|NCT00258674|EG000|Reported Event|Claims|Physician feedback of patient process measures using Medicare claims data
10844091|NCT00258674|EG001|Reported Event|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
10844092|NCT00258674|EG002|Reported Event|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
10844093|NCT00258817|BG000|Baseline|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
10844094|NCT00258817|BG001|Baseline|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
10844095|NCT00258817|BG002|Baseline|Total|Total of all reporting groups
10844096|NCT00258817|FG000|Participant Flow|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
10844097|NCT00258817|FG001|Participant Flow|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
10844098|NCT00258817|OG000|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
10844099|NCT00258817|OG001|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
10844100|NCT00258817|EG000|Reported Event|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
10844101|NCT00258817|EG001|Reported Event|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
10844102|NCT00258830|BG000|Baseline|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844103|NCT00258830|BG001|Baseline|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844104|NCT00258830|BG002|Baseline|Total|Total of all reporting groups
10844105|NCT00258830|FG000|Participant Flow|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844106|NCT00258830|FG001|Participant Flow|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844107|NCT00258830|OG000|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844108|NCT00258830|OG001|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844109|NCT00258830|EG000|Reported Event|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844110|NCT00258830|EG001|Reported Event|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
10844111|NCT00258856|BG000|Baseline|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
10844112|NCT00258856|BG001|Baseline|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
10844113|NCT00258856|BG002|Baseline|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
10844114|NCT00258856|BG003|Baseline|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
10844115|NCT00258856|BG004|Baseline|Total|Total of all reporting groups
10844116|NCT00258856|FG000|Participant Flow|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
10844117|NCT00258856|FG001|Participant Flow|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
10844118|NCT00258856|FG002|Participant Flow|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
10844119|NCT00258856|FG003|Participant Flow|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
10844120|NCT00258856|OG000|Outcome|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
10844121|NCT00258856|OG001|Outcome|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
10844122|NCT00258856|OG002|Outcome|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
10844123|NCT00258856|OG003|Outcome|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
10844124|NCT00258856|EG000|Reported Event|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
10844125|NCT00258856|EG001|Reported Event|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
10844126|NCT00258856|EG002|Reported Event|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
10844127|NCT00258856|EG003|Reported Event|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
10844128|NCT00258882|BG000|Baseline|Adacel Vaccine Group|"Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.~Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance)"
10844129|NCT00258882|BG001|Baseline|Control Groups|Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
10844130|NCT00258882|BG002|Baseline|Total|Total of all reporting groups
10844131|NCT00258882|FG000|Participant Flow|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
10844132|NCT00258882|FG001|Participant Flow|Control Groups|For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
10844133|NCT00258882|OG000|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
10844134|NCT00258882|OG001|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
10844135|NCT00258882|OG000|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination.
10844136|NCT00258882|OG001|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
10844137|NCT00258882|OG000|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination
10844138|NCT00258882|EG000|Reported Event|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination.
10844139|NCT00258895|BG000|Baseline|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
10844140|NCT00258895|BG001|Baseline|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
10844141|NCT00258895|BG002|Baseline|Total|Total of all reporting groups
10844142|NCT00258895|FG000|Participant Flow|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
10844143|NCT00258895|FG001|Participant Flow|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
10844144|NCT00258895|OG000|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
10844145|NCT00258895|OG001|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
10844146|NCT00258895|EG000|Reported Event|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
10844147|NCT00258895|EG001|Reported Event|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
10844148|NCT00258908|BG000|Baseline|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
10844149|NCT00258908|FG000|Participant Flow|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
10844150|NCT00258908|OG000|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
10844151|NCT00258908|EG000|Reported Event|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
10844152|NCT00258960|BG000|Baseline|Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab|"Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)~Liposomal Doxorubicin~Cyclophosphamide~Trastuzumab"
10844153|NCT00258960|FG000|Participant Flow|Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab|"Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)~Liposomal Doxorubicin~Cyclophosphamide~Trastuzumab"
10844154|NCT00258960|OG000|Outcome|Caelyx,Cyclophosphamide,Trastuzumab|"Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)~Liposomal Doxorubicin~Cyclophosphamide~Trastuzumab"
10844155|NCT00258960|EG000|Reported Event|Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab|Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
10844156|NCT00259012|BG000|Baseline|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
10844157|NCT00259012|BG001|Baseline|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
10844158|NCT00259012|BG002|Baseline|Total|Total of all reporting groups
10844159|NCT00259012|FG000|Participant Flow|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
10844160|NCT00259012|FG001|Participant Flow|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
10844161|NCT00259012|OG000|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
10844162|NCT00259012|OG001|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
10844163|NCT00259012|EG000|Reported Event|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
10844164|NCT00259012|EG001|Reported Event|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
10844165|NCT00259090|BG000|Baseline|Fulvestrant|Fulvestrant 500 mg once monthly injection
10844166|NCT00259090|BG001|Baseline|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
10844167|NCT00259090|BG002|Baseline|Anastrozole|Anastrozole 1 mg once daily tablet
10844168|NCT00259090|BG003|Baseline|Total|Total of all reporting groups
10844169|NCT00259090|FG000|Participant Flow|Fulvestrant|Fulvestrant 500 mg once monthly injection
10844170|NCT00259090|FG001|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
10844171|NCT00259090|FG002|Participant Flow|Anastrozole|Anastrozole 1 mg once daily tablet
10844172|NCT00259090|OG000|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
10844173|NCT00259090|OG001|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
10844174|NCT00259090|OG002|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
10844175|NCT00259090|EG000|Reported Event|Fulvestrant|Fulvestrant 500 mg once monthly injection
10844176|NCT00259090|EG001|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
10844177|NCT00259090|EG002|Reported Event|Anastrozole|Anastrozole 1 mg once daily tablet
10844178|NCT00259272|BG000|Baseline|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844179|NCT00259272|BG001|Baseline|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
10844180|NCT00259272|BG002|Baseline|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844181|NCT00259272|BG003|Baseline|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
10844182|NCT00259272|BG004|Baseline|Total|Total of all reporting groups
10844183|NCT00259272|FG000|Participant Flow|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844184|NCT00259272|FG001|Participant Flow|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
10844185|NCT00259272|FG002|Participant Flow|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844186|NCT00259272|FG003|Participant Flow|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
10844187|NCT00259272|OG000|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844188|NCT00259272|OG001|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
10844189|NCT00259272|OG002|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
10844190|NCT00259272|OG003|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
10844191|NCT00259272|OG000|Outcome|Weight Gain Subgroup|Patients who gained more than 7% of body weight during the study.
10844192|NCT00259272|OG000|Outcome|Thymic Hypo-Reactive|As assessed by the investigator according to his clinical experience.
10844193|NCT00259272|OG001|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
10844194|NCT00259272|OG002|Outcome|Neither|As assessed by the investigator according to his clinical experience.
10844195|NCT00259272|OG000|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
10844196|NCT00259272|OG000|Outcome|Eigen Value|
10844197|NCT00259272|OG001|Outcome|Proportion|
10844198|NCT00259272|OG002|Outcome|Cumulative|
10844199|NCT00259272|EG000|Reported Event|Olanzapine|Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
10844200|NCT00259285|BG000|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
10844201|NCT00259285|FG000|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
10844202|NCT00259285|OG000|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
10844203|NCT00259285|EG000|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
10844204|NCT00259298|BG000|Baseline|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
10844205|NCT00259298|FG000|Participant Flow|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
10844206|NCT00259298|OG000|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
10844207|NCT00259298|EG000|Reported Event|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
10844208|NCT00259610|BG000|Baseline|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
10844209|NCT00259610|BG001|Baseline|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844210|NCT00259610|BG002|Baseline|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
10844211|NCT00259610|BG003|Baseline|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844212|NCT00259610|BG004|Baseline|Total|Total of all reporting groups
10844213|NCT00259610|FG000|Participant Flow|MTX + Active Etanercept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
10844214|NCT00259610|FG001|Participant Flow|MTX+ Active SSZ +HCQ|methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
10844215|NCT00259610|FG002|Participant Flow|MTX + Placebo Entaneracept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
10844216|NCT00259610|FG003|Participant Flow|MTX + Placebo SSZ + HCQ(ST)|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
10844217|NCT00259610|OG000|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
10844218|NCT00259610|OG001|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844219|NCT00259610|OG002|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
10844220|NCT00259610|OG003|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844221|NCT00259610|EG000|Reported Event|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
10844222|NCT00259610|EG001|Reported Event|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844223|NCT00259610|EG002|Reported Event|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
10844224|NCT00259610|EG003|Reported Event|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
10844225|NCT00259649|BG000|Baseline|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
10849221|NCT00295009|BG002|Baseline|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
10844226|NCT00259649|FG000|Participant Flow|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
10844227|NCT00259649|OG000|Outcome|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
10844228|NCT00259649|EG000|Reported Event|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
10844229|NCT00259740|BG000|Baseline|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
10844230|NCT00259740|BG001|Baseline|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
10844231|NCT00259740|BG002|Baseline|Total|Total of all reporting groups
10844232|NCT00259740|FG000|Participant Flow|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
10844233|NCT00259740|FG001|Participant Flow|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
10844234|NCT00259740|OG000|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
10844235|NCT00259740|OG001|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
10844236|NCT00259740|EG000|Reported Event|Denosumab 120 mg Q4W - Relapsed|
10844237|NCT00259740|EG001|Reported Event|Denosumab 120 mg Q4W - Plateau-Phase|
10844238|NCT00259857|BG000|Baseline|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
10844239|NCT00259857|BG001|Baseline|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
10844240|NCT00259857|BG002|Baseline|Total|Total of all reporting groups
10844241|NCT00259857|FG000|Participant Flow|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
10844242|NCT00259857|FG001|Participant Flow|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
10844243|NCT00259857|OG000|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
10844244|NCT00259857|OG001|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
10844245|NCT00259857|EG000|Reported Event|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
10844246|NCT00259857|EG001|Reported Event|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
10844247|NCT00260065|BG000|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
10844248|NCT00260065|FG000|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
10844249|NCT00260065|OG000|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
10844250|NCT00260065|EG000|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
10844251|NCT00260195|BG000|Baseline|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
10844252|NCT00260195|BG001|Baseline|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
10844253|NCT00260195|BG002|Baseline|Total|Total of all reporting groups
10844254|NCT00260195|FG000|Participant Flow|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
10844255|NCT00260195|FG001|Participant Flow|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
10844256|NCT00260195|OG000|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
10845137|NCT00265317|OG001|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
10844257|NCT00260195|OG001|Outcome|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
10844258|NCT00260195|OG001|Outcome|Wait-list Control Group|Waiting list
10844259|NCT00260195|EG000|Reported Event|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
10844260|NCT00260195|EG001|Reported Event|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
10844261|NCT00260208|BG000|Baseline|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
10844262|NCT00260208|BG001|Baseline|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
10844263|NCT00260208|BG002|Baseline|Total|Total of all reporting groups
10844264|NCT00260208|FG000|Participant Flow|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
10844265|NCT00260208|FG001|Participant Flow|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
10844266|NCT00260208|OG000|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
10844267|NCT00260208|OG001|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
10844268|NCT00260208|EG000|Reported Event|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
10844269|NCT00260208|EG001|Reported Event|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
10844270|NCT00260429|BG000|Baseline|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10844271|NCT00260429|BG001|Baseline|Placebo|
10844272|NCT00260429|BG002|Baseline|Total|Total of all reporting groups
10844273|NCT00260429|FG000|Participant Flow|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10844274|NCT00260429|FG001|Participant Flow|Placebo|
10844275|NCT00260429|OG000|Outcome|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10844276|NCT00260429|OG001|Outcome|Placebo|
10844277|NCT00260429|EG000|Reported Event|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
10844278|NCT00260429|EG001|Reported Event|Placebo|
10844279|NCT00260533|BG000|Baseline|Atomoxetine|Atomoxetine
10844280|NCT00260533|BG001|Baseline|Placebo|Placebo
10844281|NCT00260533|BG002|Baseline|Total|Total of all reporting groups
10844282|NCT00260533|FG000|Participant Flow|Atomoxetine|Atomoxetine 40-100 mg per day
10844283|NCT00260533|FG001|Participant Flow|Placebo|Placebo (matched capsules to atomoxetine)
10844284|NCT00260533|OG000|Outcome|Atomoxetine|Atomoxetine
10844285|NCT00260533|OG001|Outcome|Placebo|Placebo
10844286|NCT00260533|EG000|Reported Event|Atomoxetine|Atomoxetine
10844287|NCT00260533|EG001|Reported Event|Placebo|Placebo
10844288|NCT00260689|BG000|Baseline|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
10844289|NCT00260689|BG001|Baseline|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
10844290|NCT00260689|BG002|Baseline|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
10844291|NCT00260689|BG003|Baseline|Total|Total of all reporting groups
10844292|NCT00260689|FG000|Participant Flow|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
10844293|NCT00260689|FG001|Participant Flow|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
10844294|NCT00260689|FG002|Participant Flow|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
10844295|NCT00260689|OG000|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
10844296|NCT00260689|OG001|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
10844297|NCT00260689|OG002|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
10844298|NCT00260689|EG000|Reported Event|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
10844299|NCT00260689|EG001|Reported Event|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
10844300|NCT00260689|EG002|Reported Event|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
10844301|NCT00260832|BG000|Baseline|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
10844302|NCT00260832|BG001|Baseline|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
10844303|NCT00260832|BG002|Baseline|Total|Total of all reporting groups
10844304|NCT00260832|FG000|Participant Flow|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
10844305|NCT00260832|FG001|Participant Flow|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
10844306|NCT00260832|OG000|Outcome|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
10844307|NCT00260832|OG001|Outcome|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
10844308|NCT00260832|EG000|Reported Event|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
10844309|NCT00260832|EG001|Reported Event|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
10844310|NCT00260962|BG000|Baseline|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844311|NCT00260962|BG001|Baseline|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844312|NCT00260962|BG002|Baseline|Total|Total of all reporting groups
10844313|NCT00260962|FG000|Participant Flow|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844314|NCT00260962|FG001|Participant Flow|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844315|NCT00260962|OG000|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10845138|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
10845139|NCT00265317|OG000|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
10844316|NCT00260962|OG001|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844317|NCT00260962|EG000|Reported Event|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10844318|NCT00260962|EG001|Reported Event|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
10845140|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
10845141|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
10845142|NCT00265317|OG001|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
10845143|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days)and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
10845144|NCT00265317|OG001|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
10845145|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
10845146|NCT00265317|OG000|Outcome|All Participants|All participants in all phases.
10845147|NCT00265317|OG000|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
10845148|NCT00265317|OG000|Outcome|All Participants|All participants in all phases
10845149|NCT00265317|EG000|Reported Event|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
10845150|NCT00265317|EG001|Reported Event|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
10845151|NCT00265317|EG002|Reported Event|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
10845152|NCT00265317|EG003|Reported Event|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
10845153|NCT00265330|BG000|Baseline|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
10845154|NCT00265330|FG000|Participant Flow|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
10845155|NCT00265330|OG000|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
10845156|NCT00265330|EG000|Reported Event|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
10845157|NCT00265382|BG000|Baseline|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
10844319|NCT00261040|BG000|Baseline|Minimally Invasive Surgery (MIS)|"In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.~Minimally Invasive Surgery: In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her."
10844320|NCT00261040|BG001|Baseline|Standard Surgery|"The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision~Standard Surgery: The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision."
10844321|NCT00261040|BG002|Baseline|Total|Total of all reporting groups
10844322|NCT00261040|FG000|Participant Flow|Minimally Invasive Surgery (MIS)|"In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.~Minimally Invasive Surgery: In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her."
10844323|NCT00261040|FG001|Participant Flow|Standard Surgery|"The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision~Standard Surgery: The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision."
10844324|NCT00261040|OG000|Outcome|Minimally Invasive Surgery (MIS)|"In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.~Minimally Invasive Surgery: In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her."
10844325|NCT00261040|OG001|Outcome|Standard Surgery|"The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision~Standard Surgery: The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision."
10844326|NCT00261040|EG000|Reported Event|Minimally Invasive Surgery (MIS)|"In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.~Minimally Invasive Surgery: In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her."
10844327|NCT00261040|EG001|Reported Event|Standard Surgery|"The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision~Standard Surgery: The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision."
10844328|NCT00261443|BG000|Baseline|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
10844329|NCT00261443|BG001|Baseline|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
10844330|NCT00261443|BG002|Baseline|Total|Total of all reporting groups
10844331|NCT00261443|FG000|Participant Flow|Pre-Randomized Participants|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844332|NCT00261443|FG001|Participant Flow|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844333|NCT00261443|FG002|Participant Flow|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844334|NCT00261443|OG000|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
10844335|NCT00261443|OG001|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
10844336|NCT00261443|OG000|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
10844337|NCT00261443|OG001|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
10844338|NCT00261443|EG000|Reported Event|Single-Blind Aripiprazole|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844339|NCT00261443|EG001|Reported Event|Double-Blind Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844340|NCT00261443|EG002|Reported Event|Double-Blind Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844341|NCT00261443|EG003|Reported Event|Extension Phase Placebo|Phase 4 (Extension Phase): matching placebo oral tablets and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844342|NCT00261443|EG004|Reported Event|Extension Phase Aripiprazole|Phase 4 (Extension Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6-1.0 mmol/L or valproate 50-125 µg/ml.
10844343|NCT00261495|BG000|Baseline|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
10844344|NCT00261495|BG001|Baseline|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
10844345|NCT00261495|BG002|Baseline|Total|Total of all reporting groups
10844346|NCT00261495|FG000|Participant Flow|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
10844347|NCT00261495|FG001|Participant Flow|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
10844348|NCT00261495|OG000|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
10844349|NCT00261495|OG001|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
10844350|NCT00261495|EG000|Reported Event|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
10844351|NCT00261495|EG001|Reported Event|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
10844352|NCT00261716|BG000|Baseline|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
10844353|NCT00261716|BG001|Baseline|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
10844354|NCT00261716|BG002|Baseline|Total|Total of all reporting groups
10844355|NCT00261716|FG000|Participant Flow|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
10844356|NCT00261716|FG001|Participant Flow|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
10844357|NCT00261716|OG000|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
10844358|NCT00261716|OG001|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
10844359|NCT00261716|OG000|Outcome|IPS and VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~VOMI: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
10844360|NCT00261716|OG001|Outcome|IPS and IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~IE: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
10844361|NCT00261716|OG000|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
10844362|NCT00261716|OG001|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
10845165|NCT00265395|FG001|Participant Flow|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
10844363|NCT00261716|EG000|Reported Event|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
10844364|NCT00261716|EG001|Reported Event|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
10844365|NCT00261833|BG000|Baseline|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
10844366|NCT00261833|BG001|Baseline|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
10844367|NCT00261833|BG002|Baseline|Total|Total of all reporting groups
10844368|NCT00261833|FG000|Participant Flow|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
10844369|NCT00261833|FG001|Participant Flow|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
10844370|NCT00261833|OG000|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
10844371|NCT00261833|OG001|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
10844372|NCT00261833|OG001|Outcome|Placebo|Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
10844373|NCT00261833|EG000|Reported Event|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
10844374|NCT00261833|EG001|Reported Event|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
10844375|NCT00261846|BG000|Baseline|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844376|NCT00261846|BG001|Baseline|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844377|NCT00261846|BG002|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
10844378|NCT00261846|BG003|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
10844379|NCT00261846|BG004|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
10844380|NCT00261846|BG005|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
10844381|NCT00261846|BG006|Baseline|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
10844382|NCT00261846|BG007|Baseline|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
10844383|NCT00261846|BG008|Baseline|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844384|NCT00261846|BG009|Baseline|Total|Total of all reporting groups
10844385|NCT00261846|FG000|Participant Flow|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
10844386|NCT00261846|FG001|Participant Flow|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
10844387|NCT00261846|FG002|Participant Flow|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
10844388|NCT00261846|FG003|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844389|NCT00261846|FG004|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844390|NCT00261846|FG005|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
10844391|NCT00261846|FG006|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
10844392|NCT00261846|FG007|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
10844393|NCT00261846|FG008|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
10844394|NCT00261846|FG009|Participant Flow|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
10844395|NCT00261846|FG010|Participant Flow|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
10844396|NCT00261846|FG011|Participant Flow|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844397|NCT00261846|OG000|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
10844398|NCT00261846|OG001|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
10844399|NCT00261846|OG002|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
10844400|NCT00261846|OG000|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844401|NCT00261846|OG000|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844402|NCT00261846|OG001|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
10844403|NCT00261846|OG002|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
10844404|NCT00261846|OG003|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
10844405|NCT00261846|OG004|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
10844406|NCT00261846|OG005|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844407|NCT00261846|OG001|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844408|NCT00261846|OG002|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
10844409|NCT00261846|OG003|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
10844410|NCT00261846|OG004|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
10844411|NCT00261846|OG005|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
10844412|NCT00261846|OG006|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844413|NCT00261846|OG007|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
10844414|NCT00261846|OG008|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844415|NCT00261846|OG009|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
10844416|NCT00261846|OG010|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844417|NCT00261846|OG000|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844418|NCT00261846|OG001|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
10844419|NCT00261846|OG002|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844420|NCT00261846|OG003|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
10844421|NCT00261846|OG004|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844422|NCT00261846|OG006|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
10844423|NCT00261846|OG007|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
10844424|NCT00261846|OG008|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844425|NCT00261846|EG000|Reported Event|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844426|NCT00261846|EG001|Reported Event|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
10844427|NCT00261846|EG002|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
10844428|NCT00261846|EG003|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
10844429|NCT00261846|EG004|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
10844430|NCT00261846|EG005|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
10844431|NCT00261846|EG006|Reported Event|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
10844432|NCT00261846|EG007|Reported Event|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
10844433|NCT00261846|EG008|Reported Event|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
10844434|NCT00261950|BG000|Baseline|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
10844435|NCT00261950|FG000|Participant Flow|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
10844436|NCT00261950|OG000|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
10844437|NCT00261950|EG000|Reported Event|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
10844438|NCT00262002|BG000|Baseline|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844439|NCT00262002|BG001|Baseline|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844440|NCT00262002|BG002|Baseline|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844441|NCT00262002|BG003|Baseline|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844442|NCT00262002|BG004|Baseline|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844443|NCT00262002|BG005|Baseline|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844444|NCT00262002|BG006|Baseline|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844445|NCT00262002|BG007|Baseline|Total|Total of all reporting groups
10844446|NCT00262002|FG000|Participant Flow|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844447|NCT00262002|FG001|Participant Flow|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844448|NCT00262002|FG002|Participant Flow|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844449|NCT00262002|FG003|Participant Flow|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844450|NCT00262002|FG004|Participant Flow|CA24+ (MenACWY Ad+ at 2,4m)|"Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844451|NCT00262002|FG005|Participant Flow|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844452|NCT00262002|FG006|Participant Flow|CA24- (MenACWY Ad- at 2,4m)|"Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844453|NCT00262002|OG000|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10849222|NCT00295009|BG003|Baseline|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
10844454|NCT00262002|OG001|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844455|NCT00262002|OG000|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844456|NCT00262002|OG001|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844457|NCT00262002|OG000|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844458|NCT00262002|OG001|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844459|NCT00262002|OG002|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844460|NCT00262002|OG003|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844461|NCT00262002|OG001|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844462|NCT00262002|OG003|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844463|NCT00262002|OG001|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844464|NCT00262002|OG002|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844465|NCT00262002|OG003|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844466|NCT00262002|OG004|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844467|NCT00262002|OG003|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844468|NCT00262002|OG004|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844469|NCT00262002|OG000|Outcome|UKMenC (Menjugate 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844470|NCT00262002|OG001|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844471|NCT00262002|OG003|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844472|NCT00262002|OG000|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844473|NCT00262002|OG003|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844474|NCT00262002|OG000|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
10849223|NCT00295009|BG004|Baseline|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
10844475|NCT00262002|OG000|Outcome|CA246+ (MenACWY Ad+ at 2,4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844476|NCT00262002|OG000|Outcome|CA246+ (MenACWY Ad+ at 2, 4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844477|NCT00262002|OG000|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844478|NCT00262002|OG001|Outcome|CA24- (MenACWY Ad- at 2, 4m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844479|NCT00262002|OG000|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844480|NCT00262002|OG001|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844481|NCT00262002|OG001|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844482|NCT00262002|OG002|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844483|NCT00262002|OG000|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844484|NCT00262002|OG001|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844485|NCT00262002|OG002|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844486|NCT00262002|OG003|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844487|NCT00262002|OG004|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844488|NCT00262002|OG005|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844489|NCT00262002|OG002|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844490|NCT00262002|OG003|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844491|NCT00262002|OG004|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844492|NCT00262002|OG005|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10849682|NCT00297427|OG001|Outcome|Sham Acupuncture|Sham acupuncture twice a week for 6 weeks
10844493|NCT00262002|OG002|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844494|NCT00262002|OG003|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844495|NCT00262002|OG004|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844496|NCT00262002|OG002|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
10844497|NCT00262002|OG003|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844498|NCT00262002|OG004|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844499|NCT00262002|OG005|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844500|NCT00262002|OG006|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844501|NCT00262002|OG000|Outcome|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
10844502|NCT00262002|OG003|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10844503|NCT00262002|OG004|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844504|NCT00262002|OG005|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844505|NCT00262002|OG006|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844506|NCT00262002|OG007|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
10844507|NCT00262002|OG008|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844508|NCT00262002|OG009|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
10844509|NCT00262002|EG000|Reported Event|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
10844510|NCT00262002|EG001|Reported Event|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
10844511|NCT00262002|EG002|Reported Event|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
10844512|NCT00262002|EG003|Reported Event|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
10845292|NCT00266227|EG002|Reported Event|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
10844513|NCT00262002|EG004|Reported Event|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844514|NCT00262002|EG005|Reported Event|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
10844515|NCT00262002|EG006|Reported Event|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
10844516|NCT00262028|BG000|Baseline|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844517|NCT00262028|BG001|Baseline|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
10844518|NCT00262028|BG002|Baseline|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844519|NCT00262028|BG003|Baseline|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
10844520|NCT00262028|BG004|Baseline|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844521|NCT00262028|BG005|Baseline|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
10844522|NCT00262028|BG006|Baseline|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844523|NCT00262028|BG007|Baseline|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
10844524|NCT00262028|BG008|Baseline|MenACWY+PS (3-5 YearsOld)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
10844525|NCT00262028|BG009|Baseline|Total|Total of all reporting groups
10844526|NCT00262028|FG000|Participant Flow|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
10844527|NCT00262028|FG001|Participant Flow|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
10844528|NCT00262028|FG002|Participant Flow|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844529|NCT00262028|FG003|Participant Flow|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
10844530|NCT00262028|FG004|Participant Flow|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844531|NCT00262028|FG005|Participant Flow|MenACWY+PnC (12-15 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
10844532|NCT00262028|FG006|Participant Flow|MenACWY (16-23 Months)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844533|NCT00262028|FG007|Participant Flow|MenACWY+DTaP (16-23 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
10844534|NCT00262028|FG008|Participant Flow|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
10844535|NCT00262028|OG000|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844536|NCT00262028|OG001|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844537|NCT00262028|OG000|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844538|NCT00262028|OG001|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844539|NCT00262028|OG002|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM vaccine
10844540|NCT00262028|OG003|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
10844541|NCT00262028|OG000|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844542|NCT00262028|OG001|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
10844543|NCT00262028|OG001|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the MenACWY-PS vaccine
10844544|NCT00262028|OG002|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of MenACWY-CRM conjugate vaccine
10844545|NCT00262028|OG003|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of MenACWY-PS vaccine
10844546|NCT00262028|OG001|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
10844547|NCT00262028|OG002|Outcome|MenACWY-CRM (2-5 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844548|NCT00262028|OG003|Outcome|MenACWY-PS (2-5 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844549|NCT00262028|OG004|Outcome|MenACWY-CRM (6-10 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844550|NCT00262028|OG005|Outcome|MenACWY-PS (6-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844551|NCT00262028|OG001|Outcome|MenACWY-PS (2-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844552|NCT00262028|OG002|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844553|NCT00262028|OG003|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844554|NCT00262028|OG004|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
10844555|NCT00262028|OG005|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
10844556|NCT00262028|OG000|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
10844557|NCT00262028|OG001|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
10844558|NCT00262028|OG002|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
10844559|NCT00262028|OG000|Outcome|MenACWY-CRM (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
10844560|NCT00262028|OG001|Outcome|MenACWY-CRM + PnC (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
10844561|NCT00262028|OG002|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
10844562|NCT00262028|OG003|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
10844563|NCT00262028|OG000|Outcome|MenACWY-CRM (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
10844564|NCT00262028|OG001|Outcome|MenACWY-CRM + PnC (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
10844565|NCT00262028|OG003|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
10844566|NCT00262028|EG000|Reported Event|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844567|NCT00262028|EG001|Reported Event|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
10844568|NCT00262028|EG002|Reported Event|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844569|NCT00262028|EG003|Reported Event|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
10844570|NCT00262028|EG004|Reported Event|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844571|NCT00262028|EG005|Reported Event|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
10844572|NCT00262028|EG006|Reported Event|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
10844573|NCT00262028|EG007|Reported Event|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
10844574|NCT00262028|EG008|Reported Event|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
10844575|NCT00262041|BG000|Baseline|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
10844576|NCT00262041|BG001|Baseline|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844577|NCT00262041|BG002|Baseline|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
10844578|NCT00262041|BG003|Baseline|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
10844579|NCT00262041|BG004|Baseline|Total|Total of all reporting groups
10844580|NCT00262041|FG000|Participant Flow|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
10844581|NCT00262041|FG001|Participant Flow|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844582|NCT00262041|FG002|Participant Flow|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
10844583|NCT00262041|OG000|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
10844584|NCT00262041|OG001|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844585|NCT00262041|OG002|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
10844586|NCT00262041|OG000|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844587|NCT00262041|OG001|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
10844588|NCT00262041|OG001|Outcome|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1)
10844589|NCT00262041|OG002|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844590|NCT00262041|OG003|Outcome|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
10844591|NCT00262041|EG000|Reported Event|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
10844592|NCT00262041|EG001|Reported Event|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
10844593|NCT00262041|EG002|Reported Event|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
10844594|NCT00262041|EG003|Reported Event|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
10844595|NCT00262067|BG000|Baseline|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844596|NCT00262067|BG001|Baseline|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844597|NCT00262067|BG002|Baseline|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844598|NCT00262067|BG003|Baseline|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844599|NCT00262067|BG004|Baseline|Total|Total of all reporting groups
10844600|NCT00262067|FG000|Participant Flow|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844601|NCT00262067|FG001|Participant Flow|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844602|NCT00262067|FG002|Participant Flow|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844603|NCT00262067|FG003|Participant Flow|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844604|NCT00262067|OG000|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844605|NCT00262067|OG001|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844606|NCT00262067|OG002|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844607|NCT00262067|OG003|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844608|NCT00262067|EG000|Reported Event|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844609|NCT00262067|EG001|Reported Event|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
10844610|NCT00262067|EG002|Reported Event|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844611|NCT00262067|EG003|Reported Event|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
10844612|NCT00262080|BG000|Baseline|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
10844613|NCT00262080|BG001|Baseline|Placebo / Ecallantide|Patients treated with placebo in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
10844614|NCT00262080|BG002|Baseline|Ecallantide (Repeat-Dosing Part Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part. One patient was omitted from analysis in the intent-to-treat and per-protocol populations due to the loss of the data for the 4-hour post-dose assessments during treatment episode 1.
10844615|NCT00262080|BG003|Baseline|Total|Total of all reporting groups
10844616|NCT00262080|FG000|Participant Flow|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
10844617|NCT00262080|FG001|Participant Flow|Placebo / Ecallantide|Patients treated with placebo in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
10844618|NCT00262080|FG002|Participant Flow|Ecallantide (Repeat Dose Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
10844619|NCT00262080|OG000|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
10844620|NCT00262080|OG001|Outcome|Placebo|Patients treated with placebo in the double-blind part.
10844621|NCT00262080|OG000|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
10844622|NCT00262080|EG000|Reported Event|Double Blind - Ecallantide|Patients treated with ecallantide in the double-blind part only.
10844623|NCT00262080|EG001|Reported Event|Double-Blind Placebo|Patients treated with placebo in the double-blind part only.
10844624|NCT00262080|EG002|Reported Event|Repeat-Dosing Ecallantide|All patients treated with ecallantide in the repeat-dosing part, regardless of whether they were treated previously in the double-blind part or not. All adverse events reported in all repeat-dosing episodes are included. Patients reporting more than 1 AE with the same preferred term are counted only once for that preferred term.
10844625|NCT00262119|BG000|Baseline|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844626|NCT00262119|BG001|Baseline|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844627|NCT00262119|BG002|Baseline|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844628|NCT00262119|BG003|Baseline|Total|Total of all reporting groups
10844629|NCT00262119|FG000|Participant Flow|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844630|NCT00262119|FG001|Participant Flow|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844631|NCT00262119|FG002|Participant Flow|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844632|NCT00262119|OG000|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844633|NCT00262119|OG001|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844634|NCT00262119|OG002|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844635|NCT00262119|EG000|Reported Event|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844636|NCT00262119|EG001|Reported Event|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844637|NCT00262119|EG002|Reported Event|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
10844638|NCT00262223|BG000|Baseline|1) Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
10844639|NCT00262223|BG001|Baseline|2) Seeking Safety + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
10844640|NCT00262223|BG002|Baseline|Total|Total of all reporting groups
10844641|NCT00262223|FG000|Participant Flow|1) Seeking Safety + Sertraline|"Seeking Safety + Sertraline~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
10844642|NCT00262223|FG001|Participant Flow|2) Seeking Safety + Placebo|"Seeking Safety + Placebo;~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
10844643|NCT00262223|OG000|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
10844644|NCT00262223|OG001|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo
10844645|NCT00262223|OG001|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo;
10844646|NCT00262223|EG000|Reported Event|Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
10844647|NCT00262223|EG001|Reported Event|Seeking Seeking + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
10844648|NCT00262301|BG000|Baseline|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
10844649|NCT00262301|BG001|Baseline|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
10844650|NCT00262301|BG002|Baseline|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
10844651|NCT00262301|BG003|Baseline|Total|Total of all reporting groups
10844652|NCT00262301|FG000|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
10844653|NCT00262301|FG001|Participant Flow|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
10844654|NCT00262301|FG002|Participant Flow|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received, 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase. Patients received 1 vial initially and could receive an additional 1-2 vials within 4 hours at the investigator's discretion."
10844655|NCT00262301|OG000|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
10844656|NCT00262301|OG001|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
10844657|NCT00262301|OG002|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
10844658|NCT00262301|EG000|Reported Event|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
10844659|NCT00262301|EG001|Reported Event|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
10844660|NCT00262301|EG002|Reported Event|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
10844661|NCT00262314|BG000|Baseline|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
10844662|NCT00262314|FG000|Participant Flow|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
10844663|NCT00262314|OG000|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
10844664|NCT00262314|EG000|Reported Event|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
10844665|NCT00262509|BG000|Baseline|First Baseline, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes."
10845158|NCT00265382|FG000|Participant Flow|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
10844666|NCT00262509|BG001|Baseline|First Intervention, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes."
10844667|NCT00262509|BG002|Baseline|Total|Total of all reporting groups
10844668|NCT00262509|FG000|Participant Flow|Baseline First, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes."
10844669|NCT00262509|FG001|Participant Flow|Intervention First, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes."
10844670|NCT00262509|OG000|Outcome|Intervention|All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
10844671|NCT00262509|OG001|Outcome|Baseline|All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
10844672|NCT00262509|EG000|Reported Event|Egress Badge Intervention|Blind Participants are trained for 15 minutes in the use of the egress badge, then for two separate trials they are walked into a building to a different locations, and are asked to find their way out of the building.
10844673|NCT00262509|EG001|Reported Event|Baseline Egress|Blind subjects are walked into a building to different locations in two separate trials and then asked to find their way out of the building.
10844674|NCT00262522|BG000|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10844675|NCT00262522|BG001|Baseline|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
10844676|NCT00262522|BG002|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10844677|NCT00262522|BG003|Baseline|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
10844678|NCT00262522|BG004|Baseline|Total|Total of all reporting groups
10844679|NCT00262522|FG000|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10844680|NCT00262522|FG001|Participant Flow|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
10844681|NCT00262522|FG002|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10844682|NCT00262522|FG003|Participant Flow|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
10844683|NCT00262522|OG000|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10844684|NCT00262522|OG001|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
10844685|NCT00262522|OG002|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10844686|NCT00262522|OG003|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
10844687|NCT00262522|EG000|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
10844688|NCT00262522|EG001|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
10844689|NCT00262600|BG000|Baseline|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
10844690|NCT00262600|BG001|Baseline|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
10844691|NCT00262600|BG002|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10844692|NCT00262600|BG003|Baseline|Total|Total of all reporting groups
10844693|NCT00262600|FG000|Participant Flow|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
10844694|NCT00262600|FG001|Participant Flow|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
10844695|NCT00262600|FG002|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10844696|NCT00262600|OG000|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
10844697|NCT00262600|OG001|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
10844698|NCT00262600|OG002|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10844699|NCT00262600|EG000|Reported Event|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
10844700|NCT00262600|EG001|Reported Event|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
10844701|NCT00262600|EG002|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
10844702|NCT00262639|BG000|Baseline|Low CIWAar Placebo|
10844703|NCT00262639|BG001|Baseline|Low CIWAar Flumazenil/Gabapentin|
10844704|NCT00262639|BG002|Baseline|High CIWAar Placebo|
10844705|NCT00262639|BG003|Baseline|High CIWAar Flumazenil/Gabapentin|
10844706|NCT00262639|BG004|Baseline|Total|Total of all reporting groups
10844707|NCT00262639|FG000|Participant Flow|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844708|NCT00262639|FG001|Participant Flow|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844709|NCT00262639|FG002|Participant Flow|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844710|NCT00262639|FG003|Participant Flow|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844711|NCT00262639|OG000|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844712|NCT00262639|OG001|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844713|NCT00262639|OG002|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844714|NCT00262639|OG003|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844715|NCT00262639|EG000|Reported Event|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844716|NCT00262639|EG001|Reported Event|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844717|NCT00262639|EG002|Reported Event|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
10844718|NCT00262639|EG003|Reported Event|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
10844719|NCT00262730|BG000|Baseline|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
10844720|NCT00262730|FG000|Participant Flow|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
10844721|NCT00262730|OG000|Outcome|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
10844722|NCT00262730|EG000|Reported Event|Treatment Arm All Subjects|"poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy~AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI"
10844723|NCT00262743|BG000|Baseline|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
10844724|NCT00262743|BG001|Baseline|Phase II Polyphenon E|2000mg twice daily for 6 months
10844725|NCT00262743|BG002|Baseline|Total|Total of all reporting groups
10844726|NCT00262743|FG000|Participant Flow|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
10844727|NCT00262743|FG001|Participant Flow|Phase II Polyphenon E|2000mg orally twice daily for 6 months
10844728|NCT00262743|OG000|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
10844729|NCT00262743|EG000|Reported Event|Phase II Polyphenon E|2000mg orally twice daily for 6 months
10844730|NCT00262821|BG000|Baseline|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844731|NCT00262821|BG001|Baseline|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844732|NCT00262821|BG002|Baseline|Total|Total of all reporting groups
10844733|NCT00262821|FG000|Participant Flow|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844734|NCT00262821|FG001|Participant Flow|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844735|NCT00262821|OG000|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10845653|NCT00268346|EG000|Reported Event|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10844736|NCT00262821|OG001|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844737|NCT00262821|EG000|Reported Event|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844738|NCT00262821|EG001|Reported Event|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
10844739|NCT00262834|BG000|Baseline|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
10844740|NCT00262834|BG001|Baseline|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
10844741|NCT00262834|BG002|Baseline|Total|Total of all reporting groups
10844742|NCT00262834|FG000|Participant Flow|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
10844743|NCT00262834|FG001|Participant Flow|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
10844744|NCT00262834|OG000|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
10844745|NCT00262834|OG001|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
10844746|NCT00262834|OG000|Outcome|Arm I|"Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.~vorinostat: Given orally, conventional surgery to follow.~conventional surgery: Undergo conventional surgery"
10844747|NCT00262834|EG000|Reported Event|Vorinostat|"Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).~Only vortinostat group adverse events were reported or collected to assess association of events with the agent in question."
10844748|NCT00262847|BG000|Baseline|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844749|NCT00262847|BG001|Baseline|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844750|NCT00262847|BG002|Baseline|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
10844751|NCT00262847|BG003|Baseline|Total|Total of all reporting groups
10844752|NCT00262847|FG000|Participant Flow|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844753|NCT00262847|FG001|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844754|NCT00262847|FG002|Participant Flow|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
10844755|NCT00262847|OG000|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844756|NCT00262847|OG001|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844757|NCT00262847|OG002|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
10844758|NCT00262847|OG000|Outcome|Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844759|NCT00262847|OG001|Outcome|Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844760|NCT00262847|OG002|Outcome|Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
10844761|NCT00262847|EG000|Reported Event|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10849683|NCT00297427|EG000|Reported Event|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
10844762|NCT00262847|EG001|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
10844763|NCT00262847|EG002|Reported Event|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
10844764|NCT00262860|BG000|Baseline|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
10844765|NCT00262860|FG000|Participant Flow|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
10844766|NCT00262860|OG000|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
10844767|NCT00262860|EG000|Reported Event|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
10844768|NCT00262873|BG000|Baseline|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
10844769|NCT00262873|FG000|Participant Flow|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
10844770|NCT00262873|OG000|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
10844771|NCT00262873|EG000|Reported Event|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
10844772|NCT00262925|BG000|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
10844773|NCT00262925|FG000|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
10844774|NCT00262925|OG000|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
10844775|NCT00262925|OG000|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"Detailed Description Section~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.~alemtuzumab: Given subcutaneously~asparaginase: Given IM~methotrexate: Given IV or orally~dexamethasone: Given orally~leucovorin calcium: Given IV~mercaptopurine tablet: Given orally~vincristine sulfate: Given IV~laboratory biomarker analysis: Correlative studies"
10844776|NCT00262925|EG000|Reported Event|MOAD+Campath-Step 1|"Campath 5mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
10844777|NCT00262925|EG001|Reported Event|MOAD+Campath-Step 2|"Campath 10 mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
10844778|NCT00262951|BG000|Baseline|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
10845159|NCT00265382|OG000|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
10844779|NCT00262951|FG000|Participant Flow|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
10844780|NCT00262951|OG000|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
10844781|NCT00262951|EG000|Reported Event|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
10844782|NCT00262964|BG000|Baseline|Controls|Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy).
10844783|NCT00262964|BG001|Baseline|NAFLD|Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms.
10844784|NCT00262964|BG002|Baseline|Total|Total of all reporting groups
10844785|NCT00262964|FG000|Participant Flow|NAFLD - Niacin|subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin.
10844786|NCT00262964|FG001|Participant Flow|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
10844787|NCT00262964|FG002|Participant Flow|Controls|Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
10844788|NCT00262964|FG003|Participant Flow|NAFLD - no Drug|Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
10844789|NCT00262964|OG000|Outcome|NAFLD|subjects with intra-hepatic triglyceride content greater than 10%.
10844790|NCT00262964|OG001|Outcome|Controls|subjects with normal intra-hepatic triglyceride levels
10844791|NCT00262964|OG000|Outcome|NAFLD|Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
10844792|NCT00262964|OG001|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
10844793|NCT00262964|OG000|Outcome|NAFLD|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
10844794|NCT00262964|OG000|Outcome|NAFLD|Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
10844795|NCT00262964|OG001|Outcome|Controls|subjects with normal intrahepatic triglyceride levels
10844796|NCT00262964|OG000|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
10844797|NCT00262964|OG001|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
10844798|NCT00262964|OG001|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
10844799|NCT00262964|OG000|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
10844800|NCT00262964|OG001|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
10844801|NCT00262964|OG000|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
10844802|NCT00262964|OG001|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
10844803|NCT00262964|OG000|Outcome|NAFLD - Fenofibrate|Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
10844804|NCT00262964|OG001|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
10844805|NCT00262964|EG000|Reported Event|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate
10844806|NCT00262964|EG001|Reported Event|NAFLD - Niacin|subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16.
10844807|NCT00262964|EG002|Reported Event|NAFLD - no Drug|subjects with elevated hepatic triglyceride who did not receive any drug intervention
10844808|NCT00262964|EG003|Reported Event|Controls|subjects with normal hepatic triglyceride.
10844809|NCT00263211|BG000|Baseline|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
10844810|NCT00263211|BG001|Baseline|Observation Only|Observation by treating physician
10844811|NCT00263211|BG002|Baseline|Total|Total of all reporting groups
10846520|NCT00277355|FG001|Participant Flow|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
10844812|NCT00263211|FG000|Participant Flow|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
10844813|NCT00263211|FG001|Participant Flow|Observation Only|Observation by treating physician
10844814|NCT00263211|OG000|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
10844815|NCT00263211|OG001|Outcome|Observation Only|Observation by treating physician
10844816|NCT00263211|OG000|Outcome|Plavix and Aspirin|
10844817|NCT00263211|OG001|Outcome|Observation Only|
10844818|NCT00263211|OG000|Outcome|Plavix and Aspirin|"Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.~Plavix"
10844819|NCT00263211|EG000|Reported Event|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
10844820|NCT00263211|EG001|Reported Event|Observation Only|Observation by treating physician
10844821|NCT00263328|BG000|Baseline|Tofacitinib|Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844822|NCT00263328|BG001|Baseline|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844823|NCT00263328|BG002|Baseline|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844824|NCT00263328|BG003|Baseline|Total|Total of all reporting groups
10844825|NCT00263328|FG000|Participant Flow|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844826|NCT00263328|FG001|Participant Flow|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844827|NCT00263328|FG002|Participant Flow|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10845160|NCT00265382|EG000|Reported Event|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
10846521|NCT00277355|OG000|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
10844828|NCT00263328|OG000|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844829|NCT00263328|OG001|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844830|NCT00263328|OG002|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844831|NCT00263328|OG000|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844832|NCT00263328|OG001|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844833|NCT00263328|EG000|Reported Event|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844834|NCT00263328|EG001|Reported Event|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844835|NCT00263328|EG002|Reported Event|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
10844836|NCT00263562|BG000|Baseline|Intervention Arm|Receipt of IV pulse of steroids (methylprednisolone) followed by a steroid taper on the subsequent days: Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
10844837|NCT00263562|BG001|Baseline|Placebo Arm|Receipt of usual care, with administration of placebo: 1) normal saline in lieu of IV methylprednisolone followed by 2) placebo tablets in lieu of prednisone tablets.
10844838|NCT00263562|BG002|Baseline|Total|Total of all reporting groups
10844839|NCT00263562|FG000|Participant Flow|Intervention (Steroids)|Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
10844840|NCT00263562|FG001|Participant Flow|Placebo|a comparison group who received standard of care therapy for acute chest syndrome, with normal saline substituted in lieu of IV solumedrol (methylprednisolone) and placebo pills in lieu of prednisone tablets (same # of tablets of placebo given as would have been administered to the intervention arm).
10849684|NCT00297427|EG001|Reported Event|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
10844841|NCT00263562|OG000|Outcome|Intervention (Steroids)|Receipt of pulse IV dose of methylprednisolone followed by a tapering dose of systemic oral corticosteroids (prednisone).
10844842|NCT00263562|OG001|Outcome|Placebo Group|Receipt of usual care, with normal saline in lieu of IV methylprednisolone and placebo tablets in lieu of prednisone tablets.
10844843|NCT00263562|OG000|Outcome|Steroid Arm|Steroid arm: Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
10844844|NCT00263562|OG001|Outcome|Comparison Group|Patients receiving usual care, with receipt of placebo (saline in lieu of intravenous methylprednisolone infusion or a number of placebo pills equivalent in number to what would have been received for the prednisone.
10844845|NCT00263562|EG000|Reported Event|Intervention Arm (Steroids)|Receipt of IV followed by oral systemic corticosteroids
10844846|NCT00263562|EG001|Reported Event|Control Group|Standard care for acute chest syndrome, with normal saline used in lieu of IV methylprednisolone and placebo tablets used in lieu of oral steroid tablets.
10844847|NCT00263575|BG000|Baseline|Sublingual Fentanyl Tablet|EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
10844848|NCT00263575|FG000|Participant Flow|Sublingual Fentanyl Tablet|EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
10844849|NCT00263575|OG000|Outcome|Titration|EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
10844850|NCT00263575|OG001|Outcome|Maintenance|All patients enrolled who continued into the maintenance period
10844851|NCT00263575|OG002|Outcome|Overall|Combination of titration and maintenance period
10844852|NCT00263575|EG000|Reported Event|Sublingual Fentanyl Tablet|EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
10844853|NCT00263588|BG000|Baseline|Cohorts A|Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings.
10844854|NCT00263588|BG001|Baseline|Cohort B|750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
10844855|NCT00263588|BG002|Baseline|Total|Total of all reporting groups
10844856|NCT00263588|FG000|Participant Flow|Cohort A|750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
10844857|NCT00263588|FG001|Participant Flow|Cohort B|750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
10844858|NCT00263588|OG000|Outcome|Cohort A|750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
10844859|NCT00263588|OG001|Outcome|Cohort B|750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
10844860|NCT00263588|OG000|Outcome|Cohorts A and B|Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
10844861|NCT00263588|EG000|Reported Event|EGF105084/Cohort A|Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
10844862|NCT00263588|EG001|Reported Event|EGF105084/Cohort B|Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings
10844863|NCT00263666|BG000|Baseline|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844864|NCT00263666|BG001|Baseline|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844865|NCT00263666|BG002|Baseline|Total|Total of all reporting groups
10844866|NCT00263666|FG000|Participant Flow|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844867|NCT00263666|FG001|Participant Flow|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844868|NCT00263666|OG000|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844869|NCT00263666|OG001|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844870|NCT00263666|EG000|Reported Event|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844871|NCT00263666|EG001|Reported Event|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
10844872|NCT00263757|BG000|Baseline|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
10844873|NCT00263757|BG001|Baseline|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
10844874|NCT00263757|BG002|Baseline|Total|Total of all reporting groups
10844875|NCT00263757|FG000|Participant Flow|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
10844876|NCT00263757|FG001|Participant Flow|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
10844877|NCT00263757|OG000|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
10844878|NCT00263757|OG001|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
10844879|NCT00263757|EG000|Reported Event|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
10844880|NCT00263757|EG001|Reported Event|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
10844881|NCT00263887|BG000|Baseline|Prolastin (60 mg/kg Body Weight)|
10844882|NCT00263887|BG001|Baseline|Placebo|
10844883|NCT00263887|BG002|Baseline|Total|Total of all reporting groups
10844884|NCT00263887|FG000|Participant Flow|Prolastin (60 mg/kg Body Weight)|
10844885|NCT00263887|FG001|Participant Flow|Placebo|
10844886|NCT00263887|OG000|Outcome|Prolastin (60 mg/kg Body Weight)|
10844887|NCT00263887|OG001|Outcome|Placebo|
10844888|NCT00263887|EG000|Reported Event|Prolastin (60 mg/kg Body Weight)|
10844889|NCT00263887|EG001|Reported Event|Placebo|
10844890|NCT00264004|BG000|Baseline|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
10844891|NCT00264004|BG001|Baseline|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
10844892|NCT00264004|BG002|Baseline|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
10844893|NCT00264004|BG003|Baseline|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
10844894|NCT00264004|BG004|Baseline|Total|Total of all reporting groups
10844895|NCT00264004|FG000|Participant Flow|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
10844896|NCT00264004|FG001|Participant Flow|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
10844897|NCT00264004|FG002|Participant Flow|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
10844898|NCT00264004|FG003|Participant Flow|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
10844899|NCT00264004|OG000|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
10844900|NCT00264004|OG001|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
10844901|NCT00264004|OG002|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
10844902|NCT00264004|OG003|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
10844903|NCT00264004|EG000|Reported Event|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
10844904|NCT00264004|EG001|Reported Event|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
10844905|NCT00264004|EG002|Reported Event|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
10844906|NCT00264004|EG003|Reported Event|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
10844907|NCT00264238|BG000|Baseline|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
10844908|NCT00264238|FG000|Participant Flow|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
10844909|NCT00264238|OG000|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of much or very much improved."
10844910|NCT00264238|OG001|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
10844911|NCT00264238|OG000|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy; that is, Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI0I rating of much or very much improved."
10844912|NCT00264238|EG000|Reported Event|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
10844913|NCT00264290|BG000|Baseline|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
10844914|NCT00264290|BG001|Baseline|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
10844915|NCT00264290|BG002|Baseline|Total|Total of all reporting groups
10844916|NCT00264290|FG000|Participant Flow|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
10844917|NCT00264290|FG001|Participant Flow|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
10844918|NCT00264290|OG000|Outcome|Placebo|placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
10844919|NCT00264290|OG001|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
10844920|NCT00264290|OG000|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir: 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
10844921|NCT00264290|OG001|Outcome|Placebo|"900mg PO qd~Placebo: Placebo designed to resemble Valganciclovir"
10844922|NCT00264290|OG000|Outcome|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
10844923|NCT00264290|OG001|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
10844924|NCT00264290|EG000|Reported Event|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
10844925|NCT00264290|EG001|Reported Event|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
10844926|NCT00264303|BG000|Baseline|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
10844927|NCT00264303|BG001|Baseline|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
10844928|NCT00264303|BG002|Baseline|Total|Total of all reporting groups
10844929|NCT00264303|FG000|Participant Flow|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
10844930|NCT00264303|FG001|Participant Flow|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
10844931|NCT00264303|OG000|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
10844932|NCT00264303|OG001|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
10844933|NCT00264303|EG000|Reported Event|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
10844934|NCT00264303|EG001|Reported Event|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
10844935|NCT00264381|BG000|Baseline|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
10844936|NCT00264381|BG001|Baseline|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
10844937|NCT00264381|BG002|Baseline|Total|Total of all reporting groups
10844938|NCT00264381|FG000|Participant Flow|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
10844939|NCT00264381|FG001|Participant Flow|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
10844940|NCT00264381|OG000|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
10844941|NCT00264381|OG001|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
10844942|NCT00264381|EG000|Reported Event|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
10844943|NCT00264381|EG001|Reported Event|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
10844944|NCT00264498|BG000|Baseline|Active Comparator|Gemcitabine + Carboplatin
10844945|NCT00264498|BG001|Baseline|Experimental|Gefitinib
10844946|NCT00264498|BG002|Baseline|Total|Total of all reporting groups
10844947|NCT00264498|FG000|Participant Flow|Active Comparator|Gemcitabine + Carboplatin
10844948|NCT00264498|FG001|Participant Flow|Experimental|Gefitinib
10844949|NCT00264498|OG000|Outcome|Active Comparator|Gemcitabine + Carboplatin
10844950|NCT00264498|OG001|Outcome|Experimental|Gefitinib
10844951|NCT00264498|EG000|Reported Event|Active Comparator|Gemcitabine + Carboplatin
10844952|NCT00264498|EG001|Reported Event|Experimental|Gefitinib
10844953|NCT00264537|BG000|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844954|NCT00264537|BG001|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844955|NCT00264537|BG002|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844956|NCT00264537|BG003|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844957|NCT00264537|BG004|Baseline|Total|Total of all reporting groups
10844958|NCT00264537|FG000|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844959|NCT00264537|FG001|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844960|NCT00264537|FG002|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844961|NCT00264537|FG003|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844962|NCT00264537|OG000|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab - Dr's discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844963|NCT00264537|OG001|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate - Dr's discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844964|NCT00264537|OG002|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844965|NCT00264537|OG003|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844966|NCT00264537|OG004|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
10844967|NCT00264537|OG003|Outcome|Group 4: Golimumab 100 mg + Methotrexate (MTX)|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844968|NCT00264537|OG004|Outcome|Combined: Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
10844969|NCT00264537|EG000|Reported Event|Group A: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
10844970|NCT00264537|EG001|Reported Event|Group B: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
10844971|NCT00264537|EG002|Reported Event|Group C: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
10844972|NCT00264550|BG000|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844973|NCT00264550|BG001|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844974|NCT00264550|BG002|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844975|NCT00264550|BG003|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844976|NCT00264550|BG004|Baseline|Total|Total of all reporting groups
10844977|NCT00264550|FG000|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10845161|NCT00265395|BG000|Baseline|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
10844978|NCT00264550|FG001|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844979|NCT00264550|FG002|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844980|NCT00264550|FG003|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844981|NCT00264550|OG000|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844982|NCT00264550|OG001|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844983|NCT00264550|OG002|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844984|NCT00264550|OG003|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
10844985|NCT00264550|OG004|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
10844986|NCT00264550|EG000|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.
10844987|NCT00264550|EG001|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.
10844988|NCT00264550|EG002|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.
10844989|NCT00264576|BG000|Baseline|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
10844990|NCT00264576|BG001|Baseline|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
10844991|NCT00264576|BG002|Baseline|Total|Total of all reporting groups
10844992|NCT00264576|FG000|Participant Flow|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
10844993|NCT00264576|FG001|Participant Flow|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
10844994|NCT00264576|OG000|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
10844995|NCT00264576|OG001|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
10844996|NCT00264576|OG000|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell- culture-derived trivalent influenza vaccine (cTIV).
10844997|NCT00264576|EG000|Reported Event|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
10844998|NCT00264576|EG001|Reported Event|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
10844999|NCT00264641|BG000|Baseline|High RAS Activity|High RAS activity is defined in the protocol
10845000|NCT00264641|BG001|Baseline|Low RAS Activity|Low RAS activity is defined in the protocol
10845001|NCT00264641|BG002|Baseline|Total|Total of all reporting groups
10845002|NCT00264641|FG000|Participant Flow|High RAS Activity|High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A
10845003|NCT00264641|FG001|Participant Flow|Low RAS Activity|Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G
10845162|NCT00265395|BG001|Baseline|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
10845163|NCT00265395|BG002|Baseline|Total|Total of all reporting groups
10846522|NCT00277355|OG001|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
10845004|NCT00264641|OG000|Outcome|All Study Participants|From a screening population ten subjects with high RAS activity - defined as serum ACE and plasma angiotensinogen concentrations in the highest quartile in the population combined with presence of AT2 receptor genotype A corresponding to low expression of the receptor (maximum stimulation via the AT1 receptor) - were selected And 10 males with low RAS activity - defined as serum ACE and plasma angiotensinogen concentrations in the lowest quartile in the population combined with the presence of AT2 receptor genotype G corresponding to high expression of the receptor (58) (minimum stimulation via the AT1 receptor) were selected
10845005|NCT00264641|EG000|Reported Event|High RAS Activity|High RAS activity is described in the protocol
10845006|NCT00264641|EG001|Reported Event|Low RAS Activity|Low RAS activity is described in the protocol
10845007|NCT00264797|BG000|Baseline|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845008|NCT00264797|BG001|Baseline|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845009|NCT00264797|BG002|Baseline|Total|Total of all reporting groups
10845010|NCT00264797|FG000|Participant Flow|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845011|NCT00264797|FG001|Participant Flow|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845012|NCT00264797|OG000|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845013|NCT00264797|OG001|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845014|NCT00264797|EG000|Reported Event|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845015|NCT00264797|EG001|Reported Event|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
10845016|NCT00264810|BG000|Baseline|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
10845017|NCT00264810|BG001|Baseline|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
10845018|NCT00264810|BG002|Baseline|Total|Total of all reporting groups
10845019|NCT00264810|FG000|Participant Flow|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
10845164|NCT00265395|FG000|Participant Flow|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
10845020|NCT00264810|FG001|Participant Flow|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
10845021|NCT00264810|OG000|Outcome|Implanted Subjects|Subjects implanted with the RNS® System
10845022|NCT00264810|OG000|Outcome|Implanted Subjects|Subjects implanted with the RNS® System.
10845023|NCT00264810|OG000|Outcome|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
10845024|NCT00264810|OG001|Outcome|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
10845025|NCT00264810|EG000|Reported Event|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
10845026|NCT00264810|EG001|Reported Event|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
10845027|NCT00264849|BG000|Baseline|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
10845028|NCT00264849|BG001|Baseline|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
10845029|NCT00264849|BG002|Baseline|Total|Total of all reporting groups
10845030|NCT00264849|FG000|Participant Flow|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
10845031|NCT00264849|FG001|Participant Flow|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
10845032|NCT00264849|OG000|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
10845033|NCT00264849|OG001|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
10845034|NCT00264849|EG000|Reported Event|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
10845035|NCT00264849|EG001|Reported Event|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
10845036|NCT00264875|BG000|Baseline|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
10845037|NCT00264875|FG000|Participant Flow|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
10845038|NCT00264875|OG000|Outcome|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
10845039|NCT00264875|EG000|Reported Event|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
10846523|NCT00277355|OG001|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
10845040|NCT00265083|BG000|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845041|NCT00265083|BG001|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845042|NCT00265083|BG002|Baseline|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
10845043|NCT00265083|BG003|Baseline|Total|Total of all reporting groups
10845044|NCT00265083|FG000|Participant Flow|Group 1: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845045|NCT00265083|FG001|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845046|NCT00265083|FG002|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
10845047|NCT00265083|OG000|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845048|NCT00265083|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
10845049|NCT00265083|OG002|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
10845050|NCT00265083|OG003|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
10845051|NCT00265083|EG000|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
10845052|NCT00265083|EG001|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
10845053|NCT00265083|EG002|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
10845054|NCT00265096|BG000|Baseline|Group 1: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845055|NCT00265096|BG001|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845056|NCT00265096|BG002|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
10845057|NCT00265096|BG003|Baseline|Total|Total of all reporting groups
10845058|NCT00265096|FG000|Participant Flow|Group 1: Placebo|Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845059|NCT00265096|FG001|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845060|NCT00265096|FG002|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
10845061|NCT00265096|OG000|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845062|NCT00265096|OG001|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
10845063|NCT00265096|OG002|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
10845064|NCT00265096|OG003|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
10845065|NCT00265096|OG002|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
10845066|NCT00265096|EG000|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
10845067|NCT00265096|EG001|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
10845068|NCT00265096|EG002|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
10846524|NCT00277355|EG000|Reported Event|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
10845069|NCT00265109|BG000|Baseline|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
10845070|NCT00265109|FG000|Participant Flow|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
10845071|NCT00265109|OG000|Outcome|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
10845072|NCT00265109|OG000|Outcome|Open Label|"Open-label trial; all participants received levetiracetam~Levetiracetam: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study."
10845073|NCT00265109|EG000|Reported Event|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
10845074|NCT00265122|BG000|Baseline|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845075|NCT00265122|BG001|Baseline|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845076|NCT00265122|BG002|Baseline|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
10845077|NCT00265122|BG003|Baseline|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
10845078|NCT00265122|BG004|Baseline|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
10845079|NCT00265122|BG005|Baseline|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
10845080|NCT00265122|BG006|Baseline|Total|Total of all reporting groups
10845081|NCT00265122|FG000|Participant Flow|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845082|NCT00265122|FG001|Participant Flow|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845083|NCT00265122|FG002|Participant Flow|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
10845084|NCT00265122|FG003|Participant Flow|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
10845085|NCT00265122|FG004|Participant Flow|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
10845086|NCT00265122|FG005|Participant Flow|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
10845087|NCT00265122|OG000|Outcome|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845088|NCT00265122|OG001|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845089|NCT00265122|OG002|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
10845090|NCT00265122|OG003|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
10845091|NCT00265122|OG004|Outcome|Population 1: Placebo SC and IV Combined|All particpants who received Placebo SC and Placebo IV
10845092|NCT00265122|OG005|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
10845093|NCT00265122|OG000|Outcome|Population 2: Ustekinumab 90 SC|Paticipants received ustekinumab 90 mg subcutaneously (SC) at Weeks 0, 1, 2, and 3 (Intervention Period 1: Weeks 0-8), and did not receive any study agent from Week 8 onward (Intervention Period 2: Weeks 8-28)
10845094|NCT00265122|OG001|Outcome|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
10845095|NCT00265122|OG000|Outcome|Population 1:Placebo SC Followed by Ustekinumab 90 mg SC|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 1, 2, 3 (Intervention Period 1: Weeks 0-8), and 90 mg ustekinumab SC at Weeks 8, 9, 10 and 11 (Intervention Period 2: Weeks 8-28)
10845096|NCT00265122|OG004|Outcome|Population 1: Placebo SC and IV Combined|All participants who received Placebo SC and Placebo IV
10845097|NCT00265122|OG005|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab SC and Ustekinumab IV
10845098|NCT00265122|EG000|Reported Event|Population 1: Placebo SC Followed by Ustekinumab SC|"Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
10845099|NCT00265122|EG001|Reported Event|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
10845100|NCT00265122|EG002|Reported Event|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|"Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled Ustekinumab 4.5 mg/kg IV followed by Placebo IV."
10845101|NCT00265122|EG003|Reported Event|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|"Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with Placebo IV followed by Ustekinumab 4.5 mg/kg IV who received ustekinumab IV at Week 0 was included in the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
10845102|NCT00265122|EG004|Reported Event|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
10845103|NCT00265122|EG005|Reported Event|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
10845104|NCT00265148|BG000|Baseline|Placebo|Eligible participants received unit oral dose of visually matching Placebo 4 milligrams (mg) for one month. Participants received escalated dose of 8 mg matching placebo for next 12 months and were followed-up to 30 days.
10845105|NCT00265148|BG001|Baseline|Rosiglitazone|Eligible participants received unit oral rosiglitazone extended release (RSG XR) 4 mg for one month with or without food. Participants received escalated dose of rosiglitazone-XR for next 12 months and were followed-up to 30 days.
10845106|NCT00265148|BG002|Baseline|Total|Total of all reporting groups
10845107|NCT00265148|FG000|Participant Flow|Placebo|Eligible participants received unit oral dose of visually matching Placebo 4 milligrams (mg) for one month. Participants received escalated dose of 8 mg matching placebo for next 12 months and were followed-up to 30 days.
10845108|NCT00265148|FG001|Participant Flow|Rosiglitazone|Eligibale participants received unit oral Rosiglitazone extended release (RSG XR) 4 mg for one month with or without food. Participants received escalated dose of rosiglitazone-XR for next 12 months and were followed-up to 30 days.
10845109|NCT00265148|OG000|Outcome|Placebo|Eligible participants received unit oral dose of visually matching Placebo 4 mg for one month. Participants received escalated dose of 8 mg matching placebo for next 12 months and were followed-up to 30 days.
10845110|NCT00265148|OG001|Outcome|Rosiglitazone|Eligible participants received unit oral rosiglitazone extended release (RSG XR) 4 mg for one month with or without food. Participants received escalated dose of rosiglitazone-XR for next 12 months and were followed-up to 30 days.
10845111|NCT00265148|OG001|Outcome|Rosiglitazone|Eligible participants received unit oral dose of visually matching Placebo 4 mg for one month. Participants received escalated dose of 8 mg matching placebo for next 12 months and were followed-up to 30 days.
10845112|NCT00265148|EG000|Reported Event|Placebo|Eligible participants received unit oral dose of visually matching Placebo 4 mg for one month. Participants received escalated dose of 8 mg matching placebo for next 12 months and were followed-up to 30 days.
10845113|NCT00265148|EG001|Reported Event|Rosiglitazone|Eligible participants received unit oral rosiglitazone extended release (RSG XR) 4 mg for one month with or without food. Participants received escalated dose of rosiglitazone-XR for next 12 months and were followed-up to 30 days.
10845114|NCT00265200|BG000|Baseline|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
10845115|NCT00265200|FG000|Participant Flow|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
10845116|NCT00265200|OG000|Outcome|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
10845117|NCT00265200|EG000|Reported Event|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
10845118|NCT00265239|BG000|Baseline|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
10845119|NCT00265239|BG001|Baseline|Placebo Group|Placebo Group
10845120|NCT00265239|BG002|Baseline|Total|Total of all reporting groups
10845121|NCT00265239|FG000|Participant Flow|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
10845122|NCT00265239|FG001|Participant Flow|Placebo Group|Placebo Group
10845123|NCT00265239|OG000|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
10845124|NCT00265239|OG001|Outcome|Placebo Group|Placebo Group
11335343|NCT03548935|FG000|Participant Flow|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335344|NCT03548935|FG001|Participant Flow|Placebo|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335345|NCT03548935|OG000|Outcome|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335346|NCT03548935|OG001|Outcome|Placebo|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335347|NCT03548935|EG000|Reported Event|Sema 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335348|NCT03548935|EG001|Reported Event|Placebo|Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
11335349|NCT03549117|BG000|Baseline|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335350|NCT03549117|BG001|Baseline|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335351|NCT03549117|BG002|Baseline|Total|Total of all reporting groups
11335352|NCT03549117|FG000|Participant Flow|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335353|NCT03549117|FG001|Participant Flow|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335354|NCT03549117|OG000|Outcome|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335355|NCT03549117|OG001|Outcome|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335356|NCT03549117|EG000|Reported Event|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335357|NCT03549117|EG001|Reported Event|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335358|NCT03549130|BG000|Baseline|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335359|NCT03549130|BG001|Baseline|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335360|NCT03549130|BG002|Baseline|Total|Total of all reporting groups
11335361|NCT03549130|FG000|Participant Flow|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11336595|NCT03569033|EG001|Reported Event|Placebo|Participants received a matching placebo tablet BID for 7 days.
11335362|NCT03549130|FG001|Participant Flow|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335363|NCT03549130|OG000|Outcome|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335364|NCT03549130|OG001|Outcome|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335365|NCT03549130|OG000|Outcome|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
11335366|NCT03549130|OG001|Outcome|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
11335367|NCT03549130|EG000|Reported Event|Active Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335368|NCT03549130|EG001|Reported Event|Placebo Nasal Strip Group|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
11335369|NCT03549234|BG000|Baseline|Erector Spinae (Single Injection)|Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335370|NCT03549234|BG001|Baseline|Paravertebral (Single Injection)|Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335371|NCT03549234|BG002|Baseline|Total|Total of all reporting groups
11335372|NCT03549234|FG000|Participant Flow|Erector Spinae (Single Injection)|Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335373|NCT03549234|FG001|Participant Flow|Paravertebral (Single Injection)|Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335374|NCT03549234|OG000|Outcome|Erector Spinae (Single Injection)|Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335375|NCT03549234|OG001|Outcome|Paravertebral (Single Injection)|Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335376|NCT03549234|EG000|Reported Event|Erector Spinae (Single Injection)|Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335377|NCT03549234|EG001|Reported Event|Paravertebral (Single Injection)|Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
11335378|NCT03549338|BG000|Baseline|Arm A (Sym004)|Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1/Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.
11335379|NCT03549338|BG001|Baseline|Arm B (Futuximab)|Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will be crossed-over to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD). Sym004 will be given at the dose level that contains the corresponding dose level of the individual antibody futuximab prior to crossover.
11335380|NCT03549338|BG002|Baseline|Arm C (Modotuximab)|Modotuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the EOC2, ongoing patients will be crossed-over to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of PD. Sym004 will be given at the dose level that contains the corresponding dose level of the individual antibody modotuximab prior to crossover.
11335381|NCT03549338|BG003|Baseline|Total|Total of all reporting groups
11335382|NCT03549338|FG000|Participant Flow|Arm A (Sym004)|"Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.~For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover."
11335383|NCT03549338|FG001|Participant Flow|Arm B (Futuximab)|Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
11335384|NCT03549338|FG002|Participant Flow|Arm C (Modotuximab)|Modotuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the EOC2, ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of PD.
11335385|NCT03549338|OG000|Outcome|Arm A (Sym004)|"Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.~For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover."
11335386|NCT03549338|OG001|Outcome|Arm B (Futuximab)|Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
11335387|NCT03549338|EG000|Reported Event|Arm A (Sym004)|Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8. For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
11337950|NCT03597178|EG000|Reported Event|Senofilcon A|Subjects that wore the senofilcon A during any in this study.
10845125|NCT00265239|EG000|Reported Event|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
10845126|NCT00265239|EG001|Reported Event|Placebo Group|Placebo Group
11338659|NCT03615183|BG001|Baseline|Panel B: MK-8527 3 mg|Single oral dose of 3 mg MK-8527 in capsule form after an 8-hour fast
10845127|NCT00265317|BG000|Baseline|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
10846525|NCT00277355|EG001|Reported Event|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
10846526|NCT00277394|BG000|Baseline|Innohep®|innohep® 175 anti-Xa IU/kg once daily
11338660|NCT03615183|BG002|Baseline|Panel C: MK-8527 1 mg|Single oral dose of 1 mg MK-8527 in capsule form after an 8-hour fast
10845128|NCT00265317|BG001|Baseline|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
10845248|NCT00265850|FG002|Participant Flow|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845249|NCT00265850|OG000|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845250|NCT00265850|OG001|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845251|NCT00265850|OG002|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845252|NCT00265850|EG000|Reported Event|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845253|NCT00265850|EG001|Reported Event|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
10845254|NCT00265889|BG000|Baseline|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
10845255|NCT00265889|FG000|Participant Flow|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
10845256|NCT00265889|OG000|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
10845257|NCT00265889|EG000|Reported Event|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
10845258|NCT00265980|BG000|Baseline|Leptin Depletion Study Participants (Total)|Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
10845259|NCT00265980|FG000|Participant Flow|Leptin Depletion Study Participants (Total)|Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
10845260|NCT00265980|OG000|Outcome|Leptin Depletion Study Participants (Total)|Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
10845261|NCT00265980|EG000|Reported Event|Leptin Depletion Study Participants (Total)|Each of the 22 participant went through the stages of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection). Since adverse events are not the primary focus of this study, the events were not collected and analyzed by the stages but for each participant during the entire study participation, therefore the data is combined.
10846527|NCT00277394|BG001|Baseline|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
10846528|NCT00277394|BG002|Baseline|Total|Total of all reporting groups
10845275|NCT00266110|BG000|Baseline|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
10845276|NCT00266110|FG000|Participant Flow|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~Sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~Therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed dendritic cells (DCs) given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~Trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
10845277|NCT00266110|OG000|Outcome|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
10845278|NCT00266110|OG000|Outcome|Dendritic Cell Vaccine|"Experimental: Dendritic Cell Vaccine~Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion"
10845279|NCT00266110|EG000|Reported Event|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
10845280|NCT00266227|BG000|Baseline|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
10845281|NCT00266227|BG001|Baseline|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
10845282|NCT00266227|BG002|Baseline|Total|Total of all reporting groups
10845283|NCT00266227|FG000|Participant Flow|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
10845284|NCT00266227|FG001|Participant Flow|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
10845285|NCT00266227|FG002|Participant Flow|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
10845286|NCT00266227|OG000|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
10845287|NCT00266227|OG001|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
10845288|NCT00266227|OG000|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
10845289|NCT00266227|OG001|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
10845290|NCT00266227|EG000|Reported Event|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
10845291|NCT00266227|EG001|Reported Event|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
10845638|NCT00268203|BG000|Baseline|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
10845639|NCT00268203|FG000|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
10845640|NCT00268203|OG000|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
10845641|NCT00268203|EG000|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
10845642|NCT00268242|BG000|Baseline|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
10845643|NCT00268242|FG000|Participant Flow|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
10845644|NCT00268242|OG000|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
10845645|NCT00268242|EG000|Reported Event|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
10845646|NCT00268346|BG000|Baseline|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10845647|NCT00268346|BG001|Baseline|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10845648|NCT00268346|BG002|Baseline|Total|Total of all reporting groups
10845649|NCT00268346|FG000|Participant Flow|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10845650|NCT00268346|FG001|Participant Flow|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
10845651|NCT00268346|OG000|Outcome|No Prior Therapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
10845652|NCT00268346|OG001|Outcome|Prior Chemotherapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
10846493|NCT00276744|BG000|Baseline|Arm 1|"PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression.~Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks~PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration."
10846494|NCT00276744|FG000|Participant Flow|Arm 1|"PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression.~Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks~PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration."
10846495|NCT00276744|OG000|Outcome|Arm 1|"PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression.~Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks~PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration."
10846496|NCT00276744|EG000|Reported Event|Arm 1|"PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression.~Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks~PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration."
10846497|NCT00276861|BG000|Baseline|Single Arm|
10846498|NCT00276861|FG000|Participant Flow|Oxaliplatin + Gemcitabine|
10846499|NCT00276861|OG000|Outcome|Single Arm|
10846500|NCT00276861|OG000|Outcome|Oxaliplatin + Gemcitabine|
10846501|NCT00276861|EG000|Reported Event|Single Arm|
10846502|NCT00277095|BG000|Baseline|ProACT|Implantable device
10846503|NCT00277095|FG000|Participant Flow|Implantable Device|ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
10846504|NCT00277095|OG000|Outcome|Urine Loss ( in Grams)|24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
10846505|NCT00277095|EG000|Reported Event|ProACT|Implantable device
10846506|NCT00277212|BG000|Baseline|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
10846507|NCT00277212|FG000|Participant Flow|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
10846508|NCT00277212|FG001|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
10846509|NCT00277212|FG002|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
10846510|NCT00277212|OG000|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
10846511|NCT00277212|OG001|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
10846512|NCT00277212|OG000|Outcome|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
10846513|NCT00277212|EG000|Reported Event|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
10846514|NCT00277212|EG001|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
10846515|NCT00277212|EG002|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
10846516|NCT00277355|BG000|Baseline|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
10846517|NCT00277355|BG001|Baseline|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
10846518|NCT00277355|BG002|Baseline|Total|Total of all reporting groups
10846519|NCT00277355|FG000|Participant Flow|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
10847599|NCT00284089|BG001|Baseline|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
10847600|NCT00284089|BG002|Baseline|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
10847601|NCT00284089|BG003|Baseline|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
10847602|NCT00284089|BG004|Baseline|Total|Total of all reporting groups
10847603|NCT00284089|FG000|Participant Flow|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
10847604|NCT00284089|FG001|Participant Flow|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
10847605|NCT00284089|FG002|Participant Flow|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
10847606|NCT00284089|FG003|Participant Flow|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
10847607|NCT00284089|OG000|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
10847608|NCT00284089|OG001|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
10847609|NCT00284089|OG000|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
10847610|NCT00284089|OG001|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
10847611|NCT00284089|EG000|Reported Event|Core Group A+B: Ranibizumab 0.3 mg|"Core means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.3 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye."
10847612|NCT00284089|EG001|Reported Event|Core Group A+B: Ranibizumab 0.5 mg|"Core means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.5 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye."
10847798|NCT00286182|FG000|Participant Flow|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
10847799|NCT00286182|FG001|Participant Flow|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
10847800|NCT00286182|OG000|Outcome|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
10847801|NCT00286182|OG001|Outcome|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
10847802|NCT00286182|EG000|Reported Event|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
10847803|NCT00286182|EG001|Reported Event|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
10847804|NCT00286221|BG000|Baseline|Supratentorial PCA Fentanyl|"PCA fentanyl: Patient controlled analgesia (PC fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847805|NCT00286221|BG001|Baseline|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes pro re nata (PRN) (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847806|NCT00286221|BG002|Baseline|Infratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847807|NCT00286221|BG003|Baseline|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847808|NCT00286221|BG004|Baseline|Total|Total of all reporting groups
10847809|NCT00286221|FG000|Participant Flow|Supratentorial PCA Fentanyl|"PCA fentanyl: Patient controlled analgesia (PCA) fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847810|NCT00286221|FG001|Participant Flow|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847811|NCT00286221|FG002|Participant Flow|Infratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847812|NCT00286221|FG003|Participant Flow|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847813|NCT00286221|OG000|Outcome|Supratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847814|NCT00286221|OG001|Outcome|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847815|NCT00286221|OG002|Outcome|Infratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847816|NCT00286221|OG003|Outcome|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10847817|NCT00286221|EG000|Reported Event|Supratentorial PCA Fentanyl|"PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
10847818|NCT00286221|EG001|Reported Event|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
10848125|NCT00288626|BG000|Baseline|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848126|NCT00288626|FG000|Participant Flow|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848127|NCT00288626|OG000|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848128|NCT00288626|OG000|Outcome|HDIT and HCT|Participants received Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848129|NCT00288626|OG000|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848130|NCT00288626|EG000|Reported Event|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until > 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
10848131|NCT00288639|BG000|Baseline|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
10848132|NCT00288639|FG000|Participant Flow|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
10848133|NCT00288639|OG000|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
10848160|NCT00288886|BG001|Baseline|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
10848161|NCT00288886|BG002|Baseline|Total|Total of all reporting groups
10848162|NCT00288886|FG000|Participant Flow|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
10848163|NCT00288886|FG001|Participant Flow|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
10848164|NCT00288886|OG000|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
10848165|NCT00288886|OG001|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
10848166|NCT00288886|EG000|Reported Event|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
10848167|NCT00288886|EG001|Reported Event|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
10848168|NCT00288912|BG000|Baseline|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
10848169|NCT00288912|BG001|Baseline|Arm 2|Usual Medical Care
10848170|NCT00288912|BG002|Baseline|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
10848171|NCT00288912|BG003|Baseline|Total|Total of all reporting groups
10848172|NCT00288912|FG000|Participant Flow|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
10848173|NCT00288912|FG001|Participant Flow|Arm 2|Usual Medical Care
10848174|NCT00288912|FG002|Participant Flow|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
10848175|NCT00288912|OG000|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
10848176|NCT00288912|OG001|Outcome|Arm 2|Usual Medical Care
10848739|NCT00291317|BG000|Baseline|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
10848740|NCT00291317|FG000|Participant Flow|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
10848741|NCT00291317|OG000|Outcome|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
10848742|NCT00291317|OG000|Outcome|DEXA|
10848743|NCT00291317|EG000|Reported Event|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
10848744|NCT00291330|BG000|Baseline|Dabigatran 150 mg|bid (twice daily) oral
10848745|NCT00291330|BG001|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
10848746|NCT00291330|BG002|Baseline|Total|Total of all reporting groups
10848747|NCT00291330|FG000|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
10848748|NCT00291330|FG001|Participant Flow|Warfarin|PRN to maintain an INR of 2.0-3.0
10848749|NCT00291330|OG000|Outcome|Dabigatran 150 mg|bid (twice daily) oral
10848750|NCT00291330|OG001|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
10848751|NCT00291330|EG000|Reported Event|Dabigatran 150 mg|bid (twice daily) oral
10848752|NCT00291330|EG001|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
10848753|NCT00291343|BG000|Baseline|Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group|Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
10848754|NCT00291343|BG001|Baseline|Tritanrix-HepB/Hiberix+Mencevax ACWY Group|Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
10848755|NCT00291343|BG002|Baseline|Total|Total of all reporting groups
10848756|NCT00291343|FG000|Participant Flow|Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group|Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
10848757|NCT00291343|FG001|Participant Flow|Tritanrix-HepB/Hiberix+Mencevax ACWY Group|Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
10848758|NCT00291343|OG000|Outcome|Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group|Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
10849224|NCT00295009|BG005|Baseline|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
10849225|NCT00295009|BG006|Baseline|Total|Total of all reporting groups
10849191|NCT00294684|OG001|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
10849192|NCT00294684|EG000|Reported Event|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
10849193|NCT00294684|EG001|Reported Event|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
10849194|NCT00294723|BG000|Baseline|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
10849195|NCT00294723|BG001|Baseline|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
10849196|NCT00294723|BG002|Baseline|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
10849197|NCT00294723|BG003|Baseline|Total|Total of all reporting groups
10849198|NCT00294723|FG000|Participant Flow|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
10849199|NCT00294723|FG001|Participant Flow|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
10849200|NCT00294723|FG002|Participant Flow|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
10849201|NCT00294723|OG000|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
10849202|NCT00294723|OG001|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
10849203|NCT00294723|OG002|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
10849204|NCT00294723|EG000|Reported Event|Lira 1.8 (Weeks 0-104)|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
10849205|NCT00294723|EG001|Reported Event|Lira 1.2 (Weeks 0-104)|Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
10849206|NCT00294723|EG002|Reported Event|Glimepiride (Weeks 0-104)|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
10849207|NCT00294723|EG003|Reported Event|Lira 1.8 (Weeks 104-195)|Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
10849208|NCT00294723|EG004|Reported Event|Lira 1.2 (Weeks 104-195)|Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
10849209|NCT00294723|EG005|Reported Event|Glimepiride (Weeks 104-195)|Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
10849210|NCT00294762|BG000|Baseline|Erlotinib|150 mg erlotinib daily
10849211|NCT00294762|BG001|Baseline|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
10849212|NCT00294762|BG002|Baseline|Total|Total of all reporting groups
10849213|NCT00294762|FG000|Participant Flow|Erlotinib|150 mg erlotinib daily
10849214|NCT00294762|FG001|Participant Flow|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
10849215|NCT00294762|OG000|Outcome|Erlotinib|150 mg erlotinib daily
10849216|NCT00294762|OG001|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
10849217|NCT00294762|EG000|Reported Event|Erlotinib|150 mg erlotinib daily
10849218|NCT00294762|EG001|Reported Event|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
10849649|NCT00297167|FG000|Participant Flow|Placebo First, Then EUR-1008 (APT-1008)|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
10849650|NCT00297167|FG001|Participant Flow|EUR-1008 (APT-1008) First, Then Placebo|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
10849651|NCT00297167|FG002|Participant Flow|EUR-1008 (APT-1008) (Open-label)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
10849652|NCT00297167|OG000|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
10849653|NCT00297167|OG001|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
10849654|NCT00297167|OG001|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
10849655|NCT00297167|EG000|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
10849656|NCT00297167|EG001|Reported Event|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
10849657|NCT00297232|BG000|Baseline|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
10849658|NCT00297232|FG000|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
10849659|NCT00297232|OG000|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
10849660|NCT00297232|EG000|Reported Event|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
10849661|NCT00297258|BG000|Baseline|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
10849662|NCT00297258|FG000|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
10849663|NCT00297258|OG000|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
10849664|NCT00297258|OG001|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
10849665|NCT00297258|OG002|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
10849666|NCT00297258|OG003|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
10849667|NCT00297258|EG000|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
10849668|NCT00297427|BG000|Baseline|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
10849669|NCT00297427|BG001|Baseline|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
10849670|NCT00297427|BG002|Baseline|Total|Total of all reporting groups
10849671|NCT00297427|FG000|Participant Flow|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
10849672|NCT00297427|FG001|Participant Flow|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
10849673|NCT00297427|OG000|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
10849674|NCT00297427|OG001|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
10849901|NCT00299130|EG000|Reported Event|Placebo + MTX|"Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab.~Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10849902|NCT00299130|EG001|Reported Event|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10849903|NCT00299130|EG002|Reported Event|Rituximab 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
10849904|NCT00299130|EG003|Reported Event|Switch Population: Placebo + MTX|Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
10849905|NCT00299130|EG004|Reported Event|Switch Population: Rituximab|Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
10849906|NCT00299130|EG005|Reported Event|Rituximab 2 x 0.5 g + MTX - Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
10849907|NCT00299130|EG006|Reported Event|Rituximab 2 x 1.0 g + MTX - Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
10849908|NCT00299156|BG000|Baseline|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849909|NCT00299156|BG001|Baseline|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849910|NCT00299156|BG002|Baseline|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849911|NCT00299156|BG003|Baseline|Total|Total of all reporting groups
10849912|NCT00299156|FG000|Participant Flow|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849913|NCT00299156|FG001|Participant Flow|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849914|NCT00299156|FG002|Participant Flow|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849915|NCT00299156|OG000|Outcome|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849916|NCT00299156|OG001|Outcome|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849917|NCT00299156|OG002|Outcome|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849918|NCT00299156|EG000|Reported Event|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849919|NCT00299156|EG001|Reported Event|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849920|NCT00299156|EG002|Reported Event|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
10849921|NCT00299182|BG000|Baseline|1 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849922|NCT00299182|BG001|Baseline|3 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10849923|NCT00299182|BG002|Baseline|10 mcg/ kg AMG531 Pre & Post Chemotherapy|"Cycle 1, Chemotherapy (R-HyperCVAD) alone.~Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)~R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m^2; plus Cyclophosphamide 300 mg/m^2, Vincristine 1.4 mg/m^2, Doxorubicin (Adriamycin) 50 mg/m^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m^2; and, R-Ara-C/MTX is Rituximab 375 mg/m^2, Cytarabine 3 g/m^2 and Methotrexate 200 mg/m^2."
10850325|NCT00302042|BG001|Baseline|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
10850326|NCT00302042|BG002|Baseline|Total|Total of all reporting groups
10850327|NCT00302042|FG000|Participant Flow|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
10850281|NCT00301418|BG000|Baseline|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
10850282|NCT00301418|FG000|Participant Flow|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
10850283|NCT00301418|OG000|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
10850284|NCT00301418|EG000|Reported Event|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
10850285|NCT00301756|BG000|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10850286|NCT00301756|FG000|Participant Flow|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10850287|NCT00301756|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10850288|NCT00301756|OG000|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
10850289|NCT00301756|OG000|Outcome|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10850290|NCT00301756|EG000|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
10850291|NCT00301808|BG000|Baseline|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
10850292|NCT00301808|FG000|Participant Flow|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
10850293|NCT00301808|OG000|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
10850294|NCT00301808|EG000|Reported Event|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
10850295|NCT00301821|BG000|Baseline|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
10850296|NCT00301821|FG000|Participant Flow|Epratuzumab + Rituximab + CHOP|One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
10850297|NCT00301821|OG000|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
10850298|NCT00301821|EG000|Reported Event|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
10850299|NCT00301834|BG000|Baseline|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
10850300|NCT00301834|FG000|Participant Flow|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
10850301|NCT00301834|OG000|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
10850302|NCT00301834|OG000|Outcome|Single Arm|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
10850303|NCT00301834|OG000|Outcome|CMV Seronegative Participants|"seronegativity means no detected presence of anti-CMV IgG, indicating no past infection by the virus"
10850304|NCT00301834|OG001|Outcome|CMV Seropositive Participants|"seropositivity means the presence of anti-CMV IgG, indicating past infection by the virus"
10850305|NCT00301834|EG000|Reported Event|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
10850306|NCT00301873|BG000|Baseline|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
10850307|NCT00301873|FG000|Participant Flow|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
10850308|NCT00301873|OG000|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
10850309|NCT00301873|EG000|Reported Event|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
10850310|NCT00301964|BG000|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
10850311|NCT00301964|FG000|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
10850312|NCT00301964|OG000|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
10850313|NCT00301964|OG000|Outcome|Grade 0|Number of patients who did not experience the specified AE.
10850314|NCT00301964|OG001|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
10850315|NCT00301964|OG002|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
10850316|NCT00301964|OG003|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
10850317|NCT00301964|OG004|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
10850318|NCT00301964|OG005|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
10850319|NCT00301964|EG000|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
10850320|NCT00302003|BG000|Baseline|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
10850321|NCT00302003|FG000|Participant Flow|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
10850322|NCT00302003|OG000|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
10850323|NCT00302003|EG000|Reported Event|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
10850324|NCT00302042|BG000|Baseline|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
10850466|NCT00302731|OG000|Outcome|Study Arm 1|Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
10850467|NCT00302731|OG001|Outcome|Study Arm 2|Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
10850468|NCT00302731|OG002|Outcome|Study Arm 3|Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
10850469|NCT00302731|OG003|Outcome|Study Arm 4|Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
10850470|NCT00302731|EG000|Reported Event|Study Arm 1|"Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate~Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate"
10850471|NCT00302731|EG001|Reported Event|Study Arm 2|"Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
10850472|NCT00302731|EG002|Reported Event|Study Arm 3|"estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
10850473|NCT00302731|EG003|Reported Event|Study Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
10850474|NCT00302848|BG000|Baseline|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
10850475|NCT00302848|BG001|Baseline|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
10850476|NCT00302848|BG002|Baseline|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
10850477|NCT00302848|BG003|Baseline|Total|Total of all reporting groups
10850478|NCT00302848|FG000|Participant Flow|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
10850479|NCT00302848|FG001|Participant Flow|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
10850480|NCT00302848|FG002|Participant Flow|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
10850481|NCT00302848|OG000|Outcome|Users of DRSP|Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
10850482|NCT00302848|OG001|Outcome|Users of LNG|Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
10850483|NCT00302848|EG000|Reported Event|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
10850484|NCT00302848|EG001|Reported Event|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
10850485|NCT00302848|EG002|Reported Event|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
10850486|NCT00302952|BG000|Baseline|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
10850487|NCT00302952|BG001|Baseline|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
10850488|NCT00302952|BG002|Baseline|Total|Total of all reporting groups
10850489|NCT00302952|FG000|Participant Flow|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
10850490|NCT00302952|FG001|Participant Flow|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
10850491|NCT00302952|OG000|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
10850500|NCT00303069|FG000|Participant Flow|V710 5 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
10850501|NCT00303069|FG001|Participant Flow|V710 30 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
10850502|NCT00303069|FG002|Participant Flow|V710 90 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
10850503|NCT00303069|FG003|Participant Flow|Placebo|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
10850504|NCT00303069|OG000|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
10850505|NCT00303069|OG001|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
10850506|NCT00303069|OG002|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
10850507|NCT00303069|OG003|Outcome|Placebo|Saline placebo single dose at baseline.
10850508|NCT00303069|EG000|Reported Event|V710 5 μg|V710 5 μg single dose at baseline.
10850509|NCT00303069|EG001|Reported Event|V710 30 μg|V710 30 μg single dose at baseline.
10850510|NCT00303069|EG002|Reported Event|V710 90 μg|V710 90 μg single dose at baseline.
10850511|NCT00303069|EG003|Reported Event|Placebo|Saline placebo single dose at baseline.
10850512|NCT00303108|BG000|Baseline|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
10850513|NCT00303108|BG001|Baseline|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
10850514|NCT00303108|BG002|Baseline|D+C+H|Doxil, Carboplatin, and Herceptin
10850515|NCT00303108|BG003|Baseline|Total|Total of all reporting groups
10850516|NCT00303108|FG000|Participant Flow|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
10850517|NCT00303108|FG001|Participant Flow|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
10850518|NCT00303108|FG002|Participant Flow|D+C+H|Doxil, Carboplatin, and Herceptin
10850519|NCT00303108|OG000|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
10850520|NCT00303108|OG001|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
10850521|NCT00303108|OG002|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
10850522|NCT00303108|EG000|Reported Event|D+C and Taxane Naive or Pretreated|Doxil, Carboplatin and Taxane naive or pretreated.
10850523|NCT00303108|EG001|Reported Event|D+C+H|Doxil, Carboplatin, and Herceptin
10850524|NCT00303186|BG000|Baseline|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
10850525|NCT00303186|FG000|Participant Flow|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
10850526|NCT00303186|OG000|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
10850527|NCT00303186|EG000|Reported Event|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
10850745|NCT00304187|OG000|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin: Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
10850746|NCT00304187|OG001|Outcome|Placebo|"Participants will take matched placebo.~Placebo: Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
10850716|NCT00304083|OG000|Outcome|NF1 MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850717|NCT00304083|OG001|Outcome|Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850718|NCT00304083|OG000|Outcome|NF1 and Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850719|NCT00304083|EG000|Reported Event|NF1 and Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin ('IA') followed by 2 cycles of ifosfamide + etoposide ('IE') prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of 'IA' followed by 2 cycles of 'IE' beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of 'IE' during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of 'IA' after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
10850720|NCT00304096|BG000|Baseline|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
10850721|NCT00304096|BG001|Baseline|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
10850722|NCT00304096|BG002|Baseline|Total|Total of all reporting groups
10850723|NCT00304096|FG000|Participant Flow|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
10850724|NCT00304096|FG001|Participant Flow|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
10850725|NCT00304096|OG000|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
10850726|NCT00304096|OG001|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
10850727|NCT00304096|EG000|Reported Event|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
10850728|NCT00304096|EG001|Reported Event|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
10850729|NCT00304161|BG000|Baseline|Atomoxetine|Participants will receive atomoxetine treatment
10850730|NCT00304161|BG001|Baseline|Placebo|Participants will receive placebo treatment
10850731|NCT00304161|BG002|Baseline|Total|Total of all reporting groups
10850732|NCT00304161|FG000|Participant Flow|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
10850733|NCT00304161|FG001|Participant Flow|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
10850734|NCT00304161|OG000|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
10850735|NCT00304161|OG001|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
10850736|NCT00304161|EG000|Reported Event|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
10850737|NCT00304161|EG001|Reported Event|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
10850738|NCT00304187|BG000|Baseline|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
10850739|NCT00304187|BG001|Baseline|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
10850740|NCT00304187|BG002|Baseline|Total|Total of all reporting groups
10850741|NCT00304187|FG000|Participant Flow|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
10850742|NCT00304187|FG001|Participant Flow|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
10850743|NCT00304187|OG000|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
10850744|NCT00304187|OG001|Outcome|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
10850822|NCT04511338|OG000|Outcome|Circuit A|Dialyzer with Endexo + CombiSet bloodline
10850800|NCT04721171|FG000|Participant Flow|Intervention Group|"The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.~The Bridge device: he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days."
10850801|NCT04721171|FG001|Participant Flow|Placebo Group|"The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days.~The Bridge device: he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days."
10850802|NCT04721171|OG000|Outcome|Intervention Group|"The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.~The Bridge device: he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days."
10850803|NCT04721171|OG001|Outcome|Placebo Group|"The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days.~The Bridge device: he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days."
10850804|NCT04721171|OG000|Outcome|Intervention Group|The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
10850805|NCT04721171|OG001|Outcome|Sham Group|The sham was similar to the intervention device in all respects except that there was no current delivered.
10850806|NCT04721171|EG000|Reported Event|Intervention Group|The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
10850807|NCT04721171|EG001|Reported Event|Sham Group|"The Sham device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. It is similar to the sham but does not deliver any electrical stimulation.~This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days."
10850808|NCT04717323|BG000|Baseline|Patients|Gait with and without pelvic assistance
10850809|NCT04717323|BG001|Baseline|Controls|Gait with no pelvic assistance
10850810|NCT04717323|BG002|Baseline|Total|Total of all reporting groups
10850811|NCT04717323|FG000|Participant Flow|Patients|Gait with and without pelvic assistance
10850812|NCT04717323|FG001|Participant Flow|Controls|Gait with no pelvic assistance
10850813|NCT04717323|OG000|Outcome|Patients|Gait with and without pelvic assistance
10850814|NCT04717323|OG001|Outcome|Controls|Gait with no pelvic assistance
10850815|NCT04717323|EG000|Reported Event|Pelvic Assist (Patients)|"Pelvic assistance applied for gait retraining~mPAD (or TPAD) Pelvic Assist Device: Gait retraining device that applies pelvic forces and measures response~No Intervention: Gait with no pelvic assistance"
10850816|NCT04717323|EG001|Reported Event|No Intervention (Controls)|"Gait with no pelvic assistance~No Intervention: Gait with no pelvic assistance"
10850817|NCT04511338|BG000|Baseline|Sequence AB: Circuit A Following by Circuit B|"Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline~Dialyzer with Endexo: Sequence AB:~Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)~Sequence BA:~Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)"
10850818|NCT04511338|BG001|Baseline|Sequence BA: Circuit B Follow by Circuit A|"Circuit (B) includes dialyzer with Endexo and the Streamline bloodline~Dialyzer with Endexo: Sequence AB:~Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)~Sequence BA:~Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)"
10850819|NCT04511338|BG002|Baseline|Total|Total of all reporting groups
10850820|NCT04511338|FG000|Participant Flow|Sequence AB (Circuit A and Then Circuit B)|"Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline~Dialyzer with Endexo: Sequence AB:~Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)~Sequence BA:~Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)"
10850821|NCT04511338|FG001|Participant Flow|Sequence BA (Circuit B and Then Circuit A)|"Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline~Dialyzer with Endexo: Sequence AB:~Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)~Sequence BA:~Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)"
10850842|NCT04493931|FG004|Participant Flow|Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 followed by a washout of 3 days . In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.
10850843|NCT04493931|FG005|Participant Flow|Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.
10850844|NCT04493931|FG006|Participant Flow|Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed|Japanese participants received a single dose of placebo matching gepotidacin under fed conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of placebo matching gepotidacin under fasted conditions on Day 1 of Period 2, followed by a washout of 3 days. In Period 3, participants were administered with two doses of placebo matching gepotidacin (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days.
10850845|NCT04493931|OG000|Outcome|Cohort 1: Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.
10850846|NCT04493931|OG001|Outcome|Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg|Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.
10850847|NCT04493931|OG000|Outcome|Cohort 2:Period 1: Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 2.
10850848|NCT04493931|OG001|Outcome|Cohort 2: Period 2: Gepotidacin 1500 mg + Rifampicin 600 mg|Participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) followed by a single dose of Gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2 in Cohort 2.
10850849|NCT04493931|OG000|Outcome|Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg|Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 and Period 2 in Cohort 3.
10850850|NCT04493931|OG001|Outcome|Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg|Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 and Period 2 in Cohort 3.
10850851|NCT04493931|OG000|Outcome|Cohort 4: Gepotidacin 1500 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
10850852|NCT04493931|OG001|Outcome|Cohort 4: Gepotidacin 1500 mg Fasted|Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
10850853|NCT04493931|OG000|Outcome|Cohort 4: Gepotidacin 3000 mg Fed|Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3 in Cohort 4.
10850854|NCT04493931|OG000|Outcome|Cohort 4: Placebo|Japanese participants received a single oral dose of placebo matching gepotidacin under fed conditions in Period 1 or a single dose of placebo matching gepotidacin under fasted conditions in Period 2 or two doses of placebo (given 12 hours apart) matching gepotidacin under fed conditions in Period 3 in Cohort 4.
10850855|NCT04493931|OG001|Outcome|Cohort 4: Gepotidacin 1500 mg Fed|Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
10850856|NCT04493931|OG002|Outcome|Cohort 4: Gepotidacin 1500 mg Fasted|Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.
10850857|NCT04493931|OG003|Outcome|Cohort 4: Gepotidacin 3000 mg Fed|Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
10850858|NCT04493931|OG000|Outcome|Cohort 2: Period 1: Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 2.
10850859|NCT04493931|OG001|Outcome|Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg|Participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) of Period 2 in Cohort 2.
10850860|NCT04493931|OG002|Outcome|Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg|Participants received a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2 in Cohort 2.
10850861|NCT04493931|OG000|Outcome|Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg|Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 and Period 2 in Cohort 3.
10850862|NCT04493931|EG000|Reported Event|Cohort 1: Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.
10850863|NCT04493931|EG001|Reported Event|Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg|Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.
10850864|NCT04493931|EG002|Reported Event|Cohort 2: Period 1: Gepotidacin 1500 mg|Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 2.
10850865|NCT04493931|EG003|Reported Event|Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg|Participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) of Period 2 in Cohort 2.
10850866|NCT04493931|EG004|Reported Event|Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg|Participants received a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2 in Cohort 2.
10850873|NCT04428034|BG000|Baseline|Learning Skills Together Intervention|"Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.~Learning Skills Together: Information provided in arm/group description."
10850874|NCT04428034|FG000|Participant Flow|Learning Skills Together Intervention|"Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.~Learning Skills Together: Information provided in arm/group description."
10850875|NCT04428034|OG000|Outcome|Learning Skills Together Intervention|"Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.~Learning Skills Together: Information provided in arm/group description."
10850876|NCT04428034|EG000|Reported Event|Learning Skills Together Intervention|"Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.~Learning Skills Together: Information provided in arm/group description."
10851659|NCT00307294|FG000|Participant Flow|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
10851660|NCT00307294|OG000|Outcome|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
10851661|NCT00307294|OG000|Outcome|Thalidomide and Doxil|"Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
10851662|NCT00307294|EG000|Reported Event|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
10851663|NCT00307333|BG000|Baseline|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
10851664|NCT00307333|BG001|Baseline|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
10851665|NCT00307333|BG002|Baseline|Total|Total of all reporting groups
10851666|NCT00307333|FG000|Participant Flow|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
10851667|NCT00307333|FG001|Participant Flow|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
10851668|NCT00307333|OG000|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
10851669|NCT00307333|OG001|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
10851670|NCT00307333|EG000|Reported Event|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
10851671|NCT00307333|EG001|Reported Event|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
10851672|NCT00307437|BG000|Baseline|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
10851673|NCT00307437|BG001|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
10850923|NCT03651622|FG000|Participant Flow|Hypocaloric, Low Carbohydrate|"Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.~Hypocaloric, low carbohydrate diet: Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies."
10850924|NCT03651622|FG001|Participant Flow|Hypocaloric, Moderate Low Fat|"Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.~Hypocaloric, moderate low fat diet: Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies."
10850925|NCT03651622|FG002|Participant Flow|Mediterranean, no Caloric Restriction|"Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.~Mediterranean diet, no caloric restriction: Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies."
10850926|NCT03651622|OG000|Outcome|Hypocaloric, Low Carbohydrate|Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10850927|NCT03651622|OG001|Outcome|Hypocaloric, Moderate Low Fat|Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10850928|NCT03651622|OG002|Outcome|Mediterranean, no Caloric Restriction|Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10850929|NCT03651622|EG000|Reported Event|Hypocaloric, Low Carbohydrate|Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10850930|NCT03651622|EG001|Reported Event|Hypocaloric, Moderate Low Fat|Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10850931|NCT03651622|EG002|Reported Event|Mediterranean, no Caloric Restriction|Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
10851674|NCT00307437|BG002|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
10851675|NCT00307437|BG003|Baseline|Total|Total of all reporting groups
10851676|NCT00307437|FG000|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
10851677|NCT00307437|FG001|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
10851678|NCT00307437|FG002|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
10851679|NCT00307437|FG003|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
10851680|NCT00307437|FG004|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
10851681|NCT00307437|FG005|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
10851682|NCT00307437|FG006|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) - patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
10851683|NCT00307437|OG000|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
10851684|NCT00307437|OG001|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
10851685|NCT00307437|OG002|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
10851010|NCT02578732|BG000|Baseline|FOLFOXA|"Schema:~1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**~Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment~Antiemetics will be administered as per standard institutional policy."
10851011|NCT02578732|FG000|Participant Flow|FOLFOXA|"Schema:~1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**~Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment~Antiemetics will be administered as per standard institutional policy."
10851012|NCT02578732|OG000|Outcome|FOLFOXA|"Schema:~1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**~Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment~Antiemetics will be administered as per standard institutional policy."
10851013|NCT02578732|EG000|Reported Event|FOLFOXA|"Schema:~1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**~Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)~It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment~Antiemetics will be administered as per standard institutional policy."
10851014|NCT02272790|BG000|Baseline|Arm A|"Adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles.~Gemcitabine 800 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851015|NCT02272790|BG001|Baseline|Arm B|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 28 day cycles.~Paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851016|NCT02272790|BG002|Baseline|Arm C|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851017|NCT02272790|BG003|Baseline|Arm C2|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851018|NCT02272790|BG004|Baseline|Arm D-175 mg|"Adavosertib 175 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851019|NCT02272790|BG005|Baseline|Arm D-225 mg|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851020|NCT02272790|BG006|Baseline|Total|Total of all reporting groups
10851021|NCT02272790|FG000|Participant Flow|Arm A|"Adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles.~Gemcitabine 800 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851022|NCT02272790|FG001|Participant Flow|Arm B|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 28 day cycles.~Paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851023|NCT02272790|FG002|Participant Flow|Arm C|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851024|NCT02272790|FG003|Participant Flow|Arm C2|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851025|NCT02272790|FG004|Participant Flow|Arm D-175 mg|"Adavosertib 175 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851026|NCT02272790|FG005|Participant Flow|Arm D-225 mg|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851027|NCT02272790|OG000|Outcome|Arm A|"Adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles.~Gemcitabine 800 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851028|NCT02272790|OG001|Outcome|Arm B|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 28 day cycles.~Paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851029|NCT02272790|OG002|Outcome|Arm C|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851030|NCT02272790|OG003|Outcome|Arm C2|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 21 day cycles.~Carboplatin AUC 5 IV on Day 1 of 21 day cycles."
10851031|NCT02272790|OG004|Outcome|Arm D-175 mg|"Adavosertib 175 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851032|NCT02272790|OG005|Outcome|Arm D-225 mg|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3 of 28 day cycles.~Pegylated liposomal doxorubicin 40 mg/m² IV on Day 1 of 28 day cycles."
10851033|NCT02272790|OG000|Outcome|Arm A 800 mg/m² Gemcitabine|"Adavosertib175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles.~Gemcitabine 800 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851034|NCT02272790|OG001|Outcome|Arm A 1000 mg/m² Gemcitabine|"Adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles.~Gemcitabine 1000 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851035|NCT02272790|OG002|Outcome|Arm B|"Adavosertib 225 mg orally BID (5 doses over 3 days) on Days 1-3, 8-10, and 15-17 of 28 day cycles.~Paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of 28 day cycles."
10851324|NCT00305864|BG000|Baseline|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851325|NCT00305864|BG001|Baseline|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851326|NCT00305864|BG002|Baseline|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851327|NCT00305864|BG003|Baseline|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851328|NCT00305864|BG004|Baseline|Total|Total of all reporting groups
10851329|NCT00305864|FG000|Participant Flow|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851330|NCT00305864|FG001|Participant Flow|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851331|NCT00305864|FG002|Participant Flow|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851332|NCT00305864|FG003|Participant Flow|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851333|NCT00305864|OG000|Outcome|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851334|NCT00305864|OG001|Outcome|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851349|NCT00305877|EG001|Reported Event|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
10851335|NCT00305864|OG002|Outcome|Phase I: 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851336|NCT00305864|OG000|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851337|NCT00305864|EG000|Reported Event|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851338|NCT00305864|EG001|Reported Event|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851339|NCT00305864|EG002|Reported Event|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851340|NCT00305864|EG003|Reported Event|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
10851341|NCT00305877|BG000|Baseline|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
10851342|NCT00305877|BG001|Baseline|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
10851343|NCT00305877|BG002|Baseline|Total|Total of all reporting groups
10851344|NCT00305877|FG000|Participant Flow|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
10851345|NCT00305877|FG001|Participant Flow|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
10851346|NCT00305877|OG000|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
10851347|NCT00305877|OG001|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
10851348|NCT00305877|EG000|Reported Event|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
10851442|NCT00306384|BG002|Baseline|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
10851421|NCT00306202|OG000|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed.
10851422|NCT00306202|OG000|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed.
10851423|NCT00306202|OG000|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
10851424|NCT00306202|OG001|Outcome|Dasatinib 80 mg/m^2|Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
10851425|NCT00306202|OG002|Outcome|Dasatinib 100 mg/m^2|Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
10851426|NCT00306202|OG003|Outcome|Dasatinib 120 mg/m^2|Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
10851427|NCT00306202|OG000|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
10851428|NCT00306202|EG000|Reported Event|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
10851429|NCT00306202|EG001|Reported Event|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
10851430|NCT00306202|EG002|Reported Event|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
10851431|NCT00306293|BG000|Baseline|Overall Study|Participants received VALTREX 1 g (2 x500 mg caplets) and matching placebo 2 caplets, orally, OD, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
10851432|NCT00306293|FG000|Participant Flow|VALTREX 1 g First Then Placebo|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
10851433|NCT00306293|FG001|Participant Flow|Placebo First Then VALTREX 1 g|Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
10851434|NCT00306293|OG000|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
10851435|NCT00306293|OG001|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
10851436|NCT00306293|OG000|Outcome|VALTREX 1 g First Then Placebo|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
10851437|NCT00306293|OG001|Outcome|Placebo First Then VALTREX 1 g|Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
10851438|NCT00306293|EG000|Reported Event|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
10851439|NCT00306293|EG001|Reported Event|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
10851440|NCT00306384|BG000|Baseline|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
10851441|NCT00306384|BG001|Baseline|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
10851443|NCT00306384|BG003|Baseline|Total|Total of all reporting groups
10851532|NCT00306917|FG000|Participant Flow|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851533|NCT00306917|FG001|Participant Flow|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851534|NCT00306917|OG000|Outcome|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851535|NCT00306917|OG001|Outcome|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851536|NCT00306917|EG000|Reported Event|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851537|NCT00306917|EG001|Reported Event|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
10851538|NCT00306995|BG000|Baseline|SB218352_15 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851539|NCT00306995|BG001|Baseline|SB218352_8 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851540|NCT00306995|BG002|Baseline|SB218352_4 Group:|Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851541|NCT00306995|BG003|Baseline|SB218352_2 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851542|NCT00306995|BG004|Baseline|SB218352_8AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851543|NCT00306995|BG005|Baseline|SB218352_4AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851544|NCT00306995|BG006|Baseline|SB218352_2AL Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
10851545|NCT00306995|BG007|Baseline|Total|Total of all reporting groups
10851546|NCT00306995|FG000|Participant Flow|SB218352_15 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851547|NCT00306995|FG001|Participant Flow|SB218352_8 Group:|Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
10851600|NCT00307034|FG001|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851601|NCT00307034|OG000|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851602|NCT00307034|OG001|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851603|NCT00307034|EG000|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851604|NCT00307034|EG001|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
10851605|NCT00307047|BG000|Baseline|XIENCE V®|Patients recieving the XIENCE V® stent
10851606|NCT00307047|BG001|Baseline|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
10851607|NCT00307047|BG002|Baseline|Total|Total of all reporting groups
10851608|NCT00307047|FG000|Participant Flow|XIENCE V®|Patients recieving the XIENCE V® stent
10851609|NCT00307047|FG001|Participant Flow|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
10851610|NCT00307047|OG000|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
10851611|NCT00307047|OG001|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
10851612|NCT00307047|EG000|Reported Event|XIENCE V®|Patients recieving the XIENCE V® stent
10851613|NCT00307047|EG001|Reported Event|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
10851614|NCT00307086|BG000|Baseline|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
10851615|NCT00307086|FG000|Participant Flow|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
10851616|NCT00307086|OG000|Outcome|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
10851617|NCT00307086|EG000|Reported Event|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
10851618|NCT00307125|BG000|Baseline|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
10851619|NCT00307125|BG001|Baseline|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
11335463|NCT03550989|FG002|Participant Flow|IQOS Passive Users (Not Using IQOS)|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)~Non-Exposure Event: Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.~Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS)."
11335464|NCT03550989|FG003|Participant Flow|IQOS Active Users (Using IQOS)|"Each participant can participate in one Exposure Event only.~Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)~Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS)."
11335465|NCT03550989|OG000|Outcome|Non-Smokers|"Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.~Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.)."
11335466|NCT03550989|OG001|Outcome|Cigarette Smokers|"Used at least 100 cigarettes~Smokes cigarettes daily > 1/day~Uses IQOS less than daily~Uses less than 30 HeatSticks/month~Cigarette is > 95% of tobacco/nicotine product (all product use)"
11335467|NCT03550989|OG002|Outcome|IQOS Passive Users (Not Using IQOS)|"Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use)~excluding other products (e-cig/Ploom/etc.)"
11335468|NCT03550989|OG003|Outcome|IQOS Active Users (Using IQOS)|"Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use)~excluding other products (e-cig/Ploom/etc.)"
11335469|NCT03550989|OG000|Outcome|Non-Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.~Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.)."
11335470|NCT03550989|OG001|Outcome|Cigarette Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Used at least 100 cigarettes~Smokes cigarettes daily > 1/day~Uses IQOS less than daily~Uses less than 30 HeatSticks/month~Cigarette is > 95% of tobacco/nicotine product (all product use)"
11335471|NCT03550989|OG000|Outcome|Non-Exposure Event|For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
11335472|NCT03550989|OG001|Outcome|Exposure Event|For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
11335473|NCT03550989|EG000|Reported Event|Non-Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.~Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.)."
11335474|NCT03550989|EG001|Reported Event|Cigarette Smokers|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Used at least 100 cigarettes~Smokes cigarettes daily > 1/day~Uses IQOS less than daily~Uses less than 30 HeatSticks/month~Cigarette is > 95% of tobacco/nicotine product (all product use)"
11335475|NCT03550989|EG002|Reported Event|IQOS Passive Users (Not Using IQOS)|"Each participant can participate in one Non-Exposure Event and one Exposure Event only.~Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)"
11335476|NCT03550989|EG003|Reported Event|IQOS Active Users (Using IQOS)|"Each participant can participate in one Exposure Event only.~Used at least 100 HeatSticks~Uses IQOS daily > 1/day~Smokes a cigarette less than daily~Smokes less than 30 cigarettes/month~IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)"
11335477|NCT03551730|BG000|Baseline|Placebo|Placebo administered intravenously (IV) as a bolus.
11335478|NCT03551730|BG001|Baseline|Module 3 (210 mg Bolus) Original|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335479|NCT03551730|BG002|Baseline|Module 3 (420 mg Bolus) Original|420 mg andexanet IV bolus over 14 minutes (~30 mg/min)
11335480|NCT03551730|BG003|Baseline|Module 3 (210 mg) Lyophilized|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335481|NCT03551730|BG004|Baseline|Total|Total of all reporting groups
11335482|NCT03551730|FG000|Participant Flow|Placebo|Placebo administered intravenously (IV) as a bolus.
11335483|NCT03551730|FG001|Participant Flow|Module 3 (210 mg Bolus) Original|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335484|NCT03551730|FG002|Participant Flow|Module 3 (420 mg Bolus) Original|420 mg andexanet IV bolus over 14 minutes (~30 mg/min)
11335485|NCT03551730|FG003|Participant Flow|Module 3 (210 mg) Lyophilized|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335486|NCT03551730|OG000|Outcome|Placebo|Placebo administered intravenously (IV) as a bolus.
11335487|NCT03551730|OG001|Outcome|Module 3 (210 mg Bolus) Original|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335488|NCT03551730|OG002|Outcome|Module 3 (420 mg Bolus) Original|420 mg andexanet IV bolus over 14 minutes (~30 mg/min)
11335489|NCT03551730|OG003|Outcome|Module 3 (210 mg) Lyophilized|210 mg andexanet IV bolus over 7 minutes (~30 mg/min)
11335490|NCT03551730|EG000|Reported Event|Placebo|Placebo was administered intravenously (IV) as a bolus
11335602|NCT03553940|FG000|Participant Flow|M2SR|"A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.~Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine: Live monovalent influenza A/H3N2-based M2SR (M2 defective Single Replication vaccine), comprised of 5 out of 8 gene segments on the donor virus influenza A/Puerto Rico/8/34. HA and NA derive from an A/Brisbane/10/2007-like virus. Administered intranasally as a single dose.~Quadrivalent MDCK Inactivated Influenza Vaccine: A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Administered intramuscularly as a single dose."
11335603|NCT03553940|FG001|Participant Flow|Placebo|"A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.~Placebo: H3N2 M2SR vaccine placebo (normal saline). Administered intranasally as a single dose.~Quadrivalent MDCK Inactivated Influenza Vaccine: A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Administered intramuscularly as a single dose."
11335604|NCT03553940|OG000|Outcome|M2SR|A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
11335605|NCT03553940|OG001|Outcome|Placebo|A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
11335606|NCT03553940|EG000|Reported Event|M2SR|A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
11335607|NCT03553940|EG001|Reported Event|Placebo|A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
11335608|NCT03554005|BG000|Baseline|PEG Interferon Alfa-2b 0.75 mcg/kg OW|Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335609|NCT03554005|BG001|Baseline|PEG Interferon Alfa-2b 1.5 mcg/kg OW|Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335610|NCT03554005|BG002|Baseline|PEG Interferon Alfa-2b 3 mcg/kg OW|Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335611|NCT03554005|BG003|Baseline|PEG Interferon Alfa-2b 4.5 mcg/kg OW|Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335612|NCT03554005|BG004|Baseline|PEG Interferon Alfa-2b 6 mcg/kg OW|Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335613|NCT03554005|BG005|Baseline|PEG Interferon Alfa-2b 7.5 mcg/kg OW|Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335614|NCT03554005|BG006|Baseline|Total|Total of all reporting groups
11335615|NCT03554005|FG000|Participant Flow|PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)|Participants received PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335616|NCT03554005|FG001|Participant Flow|PEG Interferon Alfa-2b 1.5 mcg/kg OW|Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335617|NCT03554005|FG002|Participant Flow|PEG Interferon Alfa-2b 3 mcg/kg OW|Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335618|NCT03554005|FG003|Participant Flow|PEG Interferon Alfa-2b 4.5 mcg/kg OW|Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335619|NCT03554005|FG004|Participant Flow|PEG Interferon Alfa-2b 6 mcg/kg OW|Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
11335708|NCT03554954|FG000|Participant Flow|Food/Nutrient Intake and Sleep Quality|"Cross-sectional research design:~fasting-state blood data (plasma amino acids)~general health assessment (e.g. blood pressure, anthropometric measurement)~dietary data~stress and sleep quality assessment"
11335709|NCT03554954|OG000|Outcome|Good Sleep Quality|GSS<=5
11335684|NCT03554746|FG000|Participant Flow|GC Group|"It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks.~GC group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times~1st to 2nd: clam ex. without resistance single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th:~a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th: maintain 5th ex. lunge ex. without hip internal rotation"
11335685|NCT03554746|FG001|Participant Flow|CG Group|"It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.~CG group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps"
11335686|NCT03554746|OG000|Outcome|GC Group|"It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks.~GC group: 1. core stability training: hold 5s/rep, 20 reps/times~supine, pelvic posterior tilt with TrA contraction.~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.~All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times~1st to 2nd:~clam ex. without resistance~single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th:~a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th:~maintain 5th ex.~lunge ex. without hip internal rotation"
11335687|NCT03554746|OG001|Outcome|CG Group|"It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.~CG group: 1. core stability training: hold 5s/rep, 20 reps/times~supine, pelvic posterior tilt with TrA contraction.~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.~All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps"
11335688|NCT03554746|EG000|Reported Event|CG Group|"It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.~CG group: 1. core stability training: hold 5s/rep, 20 reps/times~supine, pelvic posterior tilt with TrA contraction.~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.~All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps"
11335689|NCT03554746|EG001|Reported Event|GC Group|"It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks.~GC group: 1. core stability training: hold 5s/rep, 20 reps/times~supine, pelvic posterior tilt with TrA contraction.~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.~All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times~a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times~1st to 2nd:~clam ex. without resistance~single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th:~a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th:~maintain 5th ex.~lunge ex. without hip internal rotation"
11335690|NCT03554772|BG000|Baseline|Placebo|"Single dose containing 0 mg of celecoxib in 10 ml solution~Placebo: Oral Solution"
11335691|NCT03554772|BG001|Baseline|DFN-15 (Celecoxib Oral Solution) 62.5 mg|"Single dose containing 62.5 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 62.5 mg: Oral Solution"
11335692|NCT03554772|BG002|Baseline|DFN-15 (Celecoxib Oral Solution) 125 mg|"Single dose containing 125 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 125 mg: Oral Solution"
11335693|NCT03554772|BG003|Baseline|DFN-15 (Celecoxib Oral Solution) 250 mg|"Single dose containing 250 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 250 mg: Oral Solution"
11335694|NCT03554772|BG004|Baseline|Total|Total of all reporting groups
11335695|NCT03554772|FG000|Participant Flow|Placebo|"Single dose containing 0 mg of celecoxib in 10 ml solution~Placebo: Oral Solution"
11335696|NCT03554772|FG001|Participant Flow|DFN-15 (Celecoxib Oral Solution) 62.5 mg|"Single dose containing 62.5 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 62.5 mg: Oral Solution"
11335697|NCT03554772|FG002|Participant Flow|DFN-15 (Celecoxib Oral Solution) 125 mg|"Single dose containing 125 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 125 mg: Oral Solution"
11335698|NCT03554772|FG003|Participant Flow|DFN-15 (Celecoxib Oral Solution) 250 mg|"Single dose containing 250 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 250 mg: Oral Solution"
11335699|NCT03554772|OG000|Outcome|Placebo|"Single dose containing 0 mg of celecoxib in 10 ml solution~Placebo: Oral Solution"
11335700|NCT03554772|OG001|Outcome|DFN-15 (Celecoxib Oral Solution) 62.5 mg|"Single dose containing 62.5 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 62.5 mg: Oral Solution"
11335701|NCT03554772|OG002|Outcome|DFN-15 (Celecoxib Oral Solution) 125 mg|"Single dose containing 125 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 125 mg: Oral Solution"
11335702|NCT03554772|OG003|Outcome|DFN-15 (Celecoxib Oral Solution) 250 mg|"Single dose containing 250 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 250 mg: Oral Solution"
11335703|NCT03554772|EG000|Reported Event|Placebo|"Single dose containing 0 mg of celecoxib in 10 ml solution~Placebo: Oral Solution"
11335704|NCT03554772|EG001|Reported Event|DFN-15 (Celecoxib Oral Solution) 62.5 mg|"Single dose containing 62.5 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 62.5 mg: Oral Solution"
11335705|NCT03554772|EG002|Reported Event|DFN-15 (Celecoxib Oral Solution) 125 mg|"Single dose containing 125 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 125 mg: Oral Solution"
11335706|NCT03554772|EG003|Reported Event|DFN-15 (Celecoxib Oral Solution) 250 mg|"Single dose containing 250 mg of celecoxib in 10 ml solution~DFN-15 (Celecoxib Oral Solution) 250 mg: Oral Solution"
11335707|NCT03554954|BG000|Baseline|Association Between Food/Nutrient Intake and Sleep Quality|This is a cross-sectional study and it does not have an arm/group
11335710|NCT03554954|OG001|Outcome|Poor Sleep Quality|GSS>5
11335711|NCT03554954|OG002|Outcome|Overall Data|Overall subject data
11335712|NCT03554954|OG000|Outcome|Good Sleep Quality|GSS=<5
11335800|NCT03557086|BG000|Baseline|Advanced Care Planning Video Decision Support Tool|"We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.~Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described"
11335801|NCT03557086|BG001|Baseline|Verbal Narrative Control|"Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant~Verbal Narrative: Verbal description of end of life care options"
11335802|NCT03557086|BG002|Baseline|Total|Total of all reporting groups
11335803|NCT03557086|FG000|Participant Flow|Advanced Care Planning Video Decision Support Tool|"We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.~Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described"
11335804|NCT03557086|FG001|Participant Flow|Verbal Narrative Control|"Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant~Verbal Narrative: Verbal description of end of life care options"
11335805|NCT03557086|OG000|Outcome|Patients Approached for Enrollment Into the Study|We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
11335806|NCT03557086|OG000|Outcome|Advanced Care Planning Video Decision Support Tool|"We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.~Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described"
11335807|NCT03557086|OG001|Outcome|Verbal Narrative Control|"Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant~Verbal Narrative: Verbal description of end of life care options"
11335808|NCT03557086|OG000|Outcome|Advanced Care Planning Video Decision Support Tool|We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.
11335809|NCT03557086|EG000|Reported Event|Advanced Care Planning Video Decision Support Tool|"We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.~Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described"
11335810|NCT03557086|EG001|Reported Event|Verbal Narrative Control|"Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant~Verbal Narrative: Verbal description of end of life care options"
11337790|NCT03594227|BG001|Baseline|ATI-501 600mg BID Dosing|"ATI-501 600mg BID dosing - oral administration~ATI-501 600mg BID dosing: ATI-501 oral low dose"
11335811|NCT03557125|BG000|Baseline|Receives QL Block|"If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.~QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance."
11335812|NCT03557125|BG001|Baseline|Receives Saline Skin Wheel No Block|"The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.~Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point."
11335813|NCT03557125|BG002|Baseline|Total|Total of all reporting groups
11335814|NCT03557125|FG000|Participant Flow|Receives QL Block|"If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.~QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance."
11335815|NCT03557125|FG001|Participant Flow|Receives Saline Skin Wheel No Block|"The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.~Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point."
11335816|NCT03557125|OG000|Outcome|Receives QL Block|"If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.~QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance."
11335817|NCT03557125|OG001|Outcome|Receives Saline Skin Wheel No Block|"The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.~Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point."
11335818|NCT03557125|EG000|Reported Event|Receives QL Block|"If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.~QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance."
11335819|NCT03557125|EG001|Reported Event|Receives Saline Skin Wheel No Block|"The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.~Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point."
11335820|NCT03557333|BG000|Baseline|24-Week Treatment Group|Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks.
11335821|NCT03557333|FG000|Participant Flow|24-Week Treatment Group|Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks.
11335822|NCT03557333|OG000|Outcome|24-Week Treatment Group|Participants dosed with INP104 as needed for up to 24 weeks of treatment.
11335823|NCT03557333|OG001|Outcome|52-Week Treatment Group|This group is a subset of participants who completed 24 weeks of treatment and continued on study for up to 52 weeks of treatment.
11336408|NCT03566238|BG002|Baseline|Placebo|"Capsules for oral administration (to match active) once daily for 24 weeks~Placebo: Placebo identical in appearance to active drug (A4250)."
11336386|NCT03565679|BG000|Baseline|MEDLINE RENEWAL PULSE OXIMETRY& Reference CO-oximetry Sensors|"Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance.~Reprocessed Oximeter: is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.~A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.~Reference Oximeter: A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study."
11336387|NCT03565679|FG000|Participant Flow|MEDLINE RENEWAL PULSE OXIMETRY and Reference CO-oximetery|"Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance.~Reprocessed Oximeter: is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.~Whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.~Reference Oximeter: A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study."
11336388|NCT03565679|OG000|Outcome|Masimo SpO2 Adhesive Sensors, Adtx (1859)|Medline ReNewal Reprocessed Masimo SpO2 Adhesive Sensors, Adtx (1859) compared to Reference CO-Oximetry (functional SaO2)
11336389|NCT03565679|OG001|Outcome|Masimo SpO2 Adhesive Sensors, Neo (2329)|Medline ReNewal Reprocessed Masimo SpO2 Adhesive Sensors, Neo (2329)Comparison to Reference CO-Oximetry (functional SaO2)
11336390|NCT03565679|OG002|Outcome|Covidien Nellcor SpO2 Sensor, MAX-A|Medline ReNewal Reprocessed Covidien Nellcor SpO2 Sensor, MAX-AComparison to Reference CO-Oximetry (functional SaO2)
11336391|NCT03565679|OG003|Outcome|Covidien Nellcor SpO2 Sensor, MAX-N|Medline ReNewal Reprocessed Covidien Nellcor SpO2 Sensor, MAX-N Comparison to Reference CO-Oximetry (functional SaO2)
11336392|NCT03565679|EG000|Reported Event|All Participants|All participants used every device
11336393|NCT03565874|BG000|Baseline|Heart Rate Variability Biofeedback|"HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.~Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events."
11336394|NCT03565874|FG000|Participant Flow|Heart Rate Variability Biofeedback|"HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.~Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events."
11336395|NCT03565874|OG000|Outcome|Heart Rate Variability Biofeedback|"HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.~Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events."
11336396|NCT03565874|EG000|Reported Event|Heart Rate Variability Biofeedback|"HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.~Heart rate variability biofeedback: Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events."
11336397|NCT03565887|BG000|Baseline|RVL-1201 Ophthalmic Solution 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD in the morning
11336398|NCT03565887|BG001|Baseline|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic Solution One drop each eye QD in the morning
11336399|NCT03565887|BG002|Baseline|Total|Total of all reporting groups
11336400|NCT03565887|FG000|Participant Flow|RVL-1201 Ophthalmic Solution 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye once-daily in the morning
11336401|NCT03565887|FG001|Participant Flow|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic Solution One drop each eye once-daily in the morning
11336402|NCT03565887|OG000|Outcome|RVL-1201 Ophthalmic Solution 0.1%|RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD in the morning
11336403|NCT03565887|OG001|Outcome|Vehicle Ophthalmic Solution|Vehicle placebo ophthalmic Solution One drop each eye QD in the morning
11336577|NCT03569020|FG000|Participant Flow|Dietitian-Directed Diet Then Self-Directed Diet|"During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.~This is followed by 4-weeks of the self-directed diet (referent diet).~During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet."
11336578|NCT03569020|FG001|Participant Flow|Self-Directed Diet Then Dietitian-Directed Diet|"During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.~During the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11336579|NCT03569020|OG000|Outcome|Dietitian-Directed Diet Then Self-Directed Diet|"Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11336580|NCT03569020|OG001|Outcome|Self-Directed Diet Then Dietitian-Directed Diet|Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
11336581|NCT03569020|OG000|Outcome|Dietitian-Directed Diet|"Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11336582|NCT03569020|OG001|Outcome|Self-Directed Diet|Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
11336583|NCT03569020|OG000|Outcome|Dietitian-Directed Diet Then Self-Directed Diet|"During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.~This is followed by 4-weeks of the self-directed diet (referent diet).~During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet."
11336584|NCT03569020|OG001|Outcome|Self-Directed Diet Then Dietitian-Directed Diet|"During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.~During the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11336585|NCT03569020|EG000|Reported Event|Dietitian-Directed Diet|"Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.~Subsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet."
11336586|NCT03569020|EG001|Reported Event|Self-Directed Diet|Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
11336587|NCT03569033|BG000|Baseline|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.
11336588|NCT03569033|BG001|Baseline|Placebo BID|Participants received a matching placebo tablet BID for 7 days.
11336589|NCT03569033|BG002|Baseline|Total|Total of all reporting groups
11336590|NCT03569033|FG000|Participant Flow|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.
11336591|NCT03569033|FG001|Participant Flow|Placebo BID|Participants received a matching placebo tablet BID for 7 days.
11336931|NCT03573804|EG000|Reported Event|Prone to Supine MRI|"The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.~Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material."
11336932|NCT03573830|BG000|Baseline|Current Material|"Participants in this arm were shown the online Transport Canada Material that is was available at the time: https://tc.canada.ca/en/road-transportation/child-car-seat-safety/stage-3-booster-seats~Transport Canada material: The current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips)."
11336933|NCT03573830|BG001|Baseline|Enhanced Material|"Participants in this arm were shown an enhanced version of the online Transport Canada Material, which includes an introduction explaining how booster seats prevent injuries caused by seat belts.~Enhanced material: Enhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine)."
11336934|NCT03573830|BG002|Baseline|Total|Total of all reporting groups
11336935|NCT03573830|FG000|Participant Flow|Current Material|"Participants in this arm were shown the online Transport Canada Material that is was available at the time: https://tc.canada.ca/en/road-transportation/child-car-seat-safety/stage-3-booster-seats~Transport Canada material: The current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips)."
11336936|NCT03573830|FG001|Participant Flow|Enhanced Material|"Participants in this arm were shown an enhanced version of the online Transport Canada Material, which includes an introduction explaining how booster seats prevent injuries caused by seat belts.~Enhanced material: Enhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine)."
11336937|NCT03573830|OG000|Outcome|Current Material|"Participants in this arm were shown the online Transport Canada Material that is was available at the time: https://tc.canada.ca/en/road-transportation/child-car-seat-safety/stage-3-booster-seats~Transport Canada material: The current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips)."
11336938|NCT03573830|OG001|Outcome|Enhanced Material|"Participants in this arm were shown an enhanced version of the online Transport Canada Material, which includes an introduction explaining how booster seats prevent injuries caused by seat belts.~Enhanced material: Enhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine)."
11336939|NCT03573830|EG000|Reported Event|All Participants|All participants who reviewed education material as part of their assigned intervention, regardless of their alocation.
11336940|NCT03573908|BG000|Baseline|Placebo|Participants randomized to receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period.
11336941|NCT03573908|BG001|Baseline|Linaclotide 290 µg|Participants randomized to receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period.
11336942|NCT03573908|BG002|Baseline|Total|Total of all reporting groups
11336943|NCT03573908|FG000|Participant Flow|Placebo|Participants were randomized to receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period.
11336944|NCT03573908|FG001|Participant Flow|Linaclotide 290 µg|Participants were randomized to receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period.
11336945|NCT03573908|FG002|Participant Flow|Placebo -> Linaclotide 290 µg|Participants who received placebo orally once daily for 12 weeks during the Treatment Period were switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.
11337633|NCT03589807|EG004|Reported Event|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
11337362|NCT03582943|OG001|Outcome|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11337363|NCT03582943|EG000|Reported Event|Remote Limb Ischemic Conditioning (RLIC)|"RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.~RLIC: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11337364|NCT03582943|EG001|Reported Event|Sham Conditioning|"Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.~Sham conditioning: See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.~Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7."
11337365|NCT03583372|BG000|Baseline|40 Weeks Vibegron 75 mg|Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337366|NCT03583372|BG001|Baseline|52 Weeks Vibegron 75 mg|Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337367|NCT03583372|BG002|Baseline|40 Weeks Tolterodine ER 4 mg|Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337368|NCT03583372|BG003|Baseline|52 Weeks Tolterodine ER 4 mg|Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337369|NCT03583372|BG004|Baseline|Total|Total of all reporting groups
11337370|NCT03583372|FG000|Participant Flow|40 Weeks Vibegron 75 mg|Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337371|NCT03583372|FG001|Participant Flow|52 Weeks Vibegron 75 mg|Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337372|NCT03583372|FG002|Participant Flow|40 Weeks Tolterodine ER 4 mg|Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337373|NCT03583372|FG003|Participant Flow|52 Weeks Tolterodine ER 4 mg|Participants who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337374|NCT03583372|OG000|Outcome|Overall Vibegron 75 mg|Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337375|NCT03583372|OG001|Outcome|Overall Tolterodine ER 4 mg|Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337376|NCT03583372|OG000|Outcome|52 Weeks Vibegron 75 mg|Participants who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337631|NCT03589807|EG002|Reported Event|"2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
11337378|NCT03583372|OG000|Outcome|52 Weeks Vibegron 75 mg|Participants who met the definition of OAB Wet at study entry (based on the PVD and had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. OAB Wet participants were those participants with an average of ≥8.0 micturitions per Diary Day (DD); with an average of ≥1.0 UUI episodes per DD; and, if stress urinary incontinence (SUI) was present, with a total number of UUI episodes greater than the total number of SUI episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337379|NCT03583372|OG001|Outcome|52 Weeks Tolterodine ER 4 mg|Participants who met the definition of OAB Wet at study entry (based on the PVD and had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, participants originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. OAB Wet participants were those participants with an average of ≥8.0 micturitions per Diary Day (DD); with an average of ≥1.0 UUI episodes per DD; and, if stress urinary incontinence (SUI) was present, with a total number of UUI episodes greater than the total number of SUI episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337380|NCT03583372|EG000|Reported Event|Overall Vibegron 75 mg|Participants who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Participants who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Participants who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337381|NCT03583372|EG001|Reported Event|Overall Tolterodine ER 4 mg|Participants who received 40 weeks and 52 weeks tolterodine ER 4 mg. Participants who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Participants who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
11337382|NCT03583385|BG000|Baseline|All Participants|All participants who received Glucophage® XR 750 mg Tablet manufactured by PT Merck Tbk, Jakarta, Indonesia or Glucophage® XR 750 mg Tablet manufactured by Merck Santé, Semoy, France on Day 1 in either first treatment period or second treatment period.
11337383|NCT03583385|FG000|Participant Flow|First Glucophage XR (Test), Then Glucophage XR (Comparator)|Participants received single oral dose of 750 milligram (mg) Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) in treatment period 1 followed by single oral dose of 750 mg Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) in treatment period 2 under fasting conditions. The two periods were separated by a 7-day wash-out period.
11337384|NCT03583385|FG001|Participant Flow|First Glucophage XR (Comparator), Then Glucophage XR (Test)|Participants received single oral dose of 750 milligram (mg) Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) in treatment period 1 followed by single oral dose of 750 mg Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) in treatment period 2 under fasting conditions. The two periods were separated by a 7-day wash-out period.
11337385|NCT03583385|OG000|Outcome|Glucophage XR (Test)|All participants who received Glucophage® XR 750 mg Tablet manufactured by PT Merck Tbk, Jakarta, Indonesia on Day 1 in either first treatment period or second treatment period.
11337386|NCT03583385|OG001|Outcome|Glucophage XR (Comparator)|All participants who received Glucophage® XR 750 mg Tablet (manufactured by Merck Santé, Semoy, France) on Day 1 in either first treatment period or second treatment period.
11337387|NCT03583385|EG000|Reported Event|Glucophage XR (Test)|All participants who received Glucophage® XR 750 mg Tablet manufactured by PT Merck Tbk, Jakarta, Indonesia on Day 1 in either first treatment period or second treatment period.
11337388|NCT03583385|EG001|Reported Event|Glucophage XR (Comparator)|All participants who received Glucophage® XR 750 mg Tablet (manufactured by Merck Santé, Semoy, France) on Day 1 in either first treatment period or second treatment period.
11337389|NCT03583450|BG000|Baseline|Perioperative Virtual Reality Headset|Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
11337390|NCT03583450|BG001|Baseline|Control|Routine anesthetic care
11337391|NCT03583450|BG002|Baseline|Total|Total of all reporting groups
11337392|NCT03583450|FG000|Participant Flow|Perioperative Virtual Reality Headset|Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
11337393|NCT03583450|FG001|Participant Flow|Control|Routine anesthetic care
11337394|NCT03583450|OG000|Outcome|Perioperative Virtual Reality Headset|Perioperative virtual reality headset with mobile app and routine anesthetic care
11337395|NCT03583450|OG001|Outcome|Control|Routine anesthetic care
11337396|NCT03583450|OG000|Outcome|Perioperative Virtual Reality Headset|"Perioperative virtual reality headset with mobile app and routine anesthetic care~Perioperative virtual reality headset with mobile app: Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)"
11337397|NCT03583450|OG000|Outcome|Perioperative Virtual Reality Headset|Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
11337398|NCT03583450|EG000|Reported Event|Perioperative Virtual Reality Headset|Perioperative virtual reality headset with mobile app and routine anesthetic care
11337399|NCT03583450|EG001|Reported Event|Control|Routine anesthetic care
11337400|NCT03583606|BG000|Baseline|ChAd3-EBO-Z + Placebo|"ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.~ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).~Placebo: 0.5 mL normal saline administered via IM injection into the deltoid."
11337632|NCT03589807|EG003|Reported Event|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
11337467|NCT03585712|EG000|Reported Event|All Enrolled Subjects|"All subjects enrolled in the study.~The adverse events were reported for all the subjects enrolled in the study for the entire length of the study.~The subjects were randomized in their respective arm in week 5. Subjects in Arm A had a 6 hour delayed pill at Day 42 +/- 3 days and a missed pill at Day 70+/- 3 days while subjects in Arm B had a missed pill at Day 70+/- 3 days and a 6 hour delayed pill at Day 42 +/- 3 days.~It was considered that the difference in investigational medication intake between the arms would not have an impact on adverse event's frequency, so the adverse events were reported for all subjects enrolled, whatever the arm they were assigned to, and for the entire length of the study."
11337468|NCT03585712|EG001|Reported Event|Perfect Use Period|"All the subjects having starting treatment period 1.~Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started the treatment period 1."
11337469|NCT03585712|EG002|Reported Event|Delayed Pill Intake|"Subjects having started a delayed pill period, meaning treatment period 2 for subjects randomized in week 5 in Arm A, and treatment period 3 for subjects in Arm B~Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period."
11337470|NCT03585712|EG003|Reported Event|Missed Pill Intake|"Subjects having started a missed pill period, meaning treatment period 3 for subjects randomized in week 5 in Arm A, and treatment period 2 for subjects in Arm B~Affected participants by an adverse event during this treatment period are reported out of the total of subjects having started this treatment period."
11337471|NCT03585790|BG000|Baseline|Multifocal Optics First, Then Single Vision Optics|First Intervention (1 week) Second Intervention (1 week)
11337472|NCT03585790|BG001|Baseline|Single Vision Optics First, Then Multifocal Optics|First Intervention (1 week) Second Intervention (1 week)
11337473|NCT03585790|BG002|Baseline|Total|Total of all reporting groups
11337474|NCT03585790|FG000|Participant Flow|Multifocal Optics First, Then Single Vision Optics|First intervention (1 week) Second intervention (1 week)
11337475|NCT03585790|FG001|Participant Flow|Single Vision Optics First, Then Multifocal Optics|First Intervention (1 week) Second Intervention (1 week)
11337476|NCT03585790|OG000|Outcome|Multifocal Optics First, Then Single Vision Optics|First Intervention (1 week) Second Intervention (1 week)
11337477|NCT03585790|OG001|Outcome|Single Vision Optics First, Then Multifocal Optics|First Intervention (1 week) Second Intervention (1 week)
11337478|NCT03585790|OG002|Outcome|Total|Total of all reporting groups
11337479|NCT03585790|EG000|Reported Event|Multifocal Optics First, Then Single Vision Optics|First Intervention (1 week) Second Intervention (1 week)
11337480|NCT03585790|EG001|Reported Event|Single Vision Optics First, Then Multifocal Optics|First Intervention (1 week) Second Intervention (1 week)
11337481|NCT03585959|BG000|Baseline|Fluoroscopic Navigation Arm|An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.
11337482|NCT03585959|FG000|Participant Flow|Fluoroscopic Navigation Arm|An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.
11337483|NCT03585959|OG000|Outcome|Fluoroscopic Navigation Arm|An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.
11337484|NCT03585959|OG000|Outcome|Fluoroscopic Navigation Arm|"An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.~superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy"
11337485|NCT03585959|OG000|Outcome|Fluorscopic Navigation Arm|An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.
11337486|NCT03585959|EG000|Reported Event|Fluoroscopic Navigation Arm|"An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.~superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy"
11337487|NCT03586167|BG000|Baseline|LID014341|LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis
11337488|NCT03586167|BG001|Baseline|Biofinity|Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
11337489|NCT03586167|BG002|Baseline|Total|Total of all reporting groups
11337490|NCT03586167|FG000|Participant Flow|LID014341|LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis
11337491|NCT03586167|FG001|Participant Flow|Biofinity|Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
11337492|NCT03586167|OG000|Outcome|LID014341|LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis
11337493|NCT03586167|OG001|Outcome|Biofinity|Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
11337494|NCT03586167|EG000|Reported Event|LID014341|LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis
11337495|NCT03586167|EG001|Reported Event|Biofinity|Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
11337789|NCT03594227|BG000|Baseline|ATI-501 400mg BID Dosing|"ATI-501 400mg BID dosing - oral administration~ATI-501 400mg BID dosing: ATI-501 oral low dose"
11337614|NCT03589807|FG000|Participant Flow|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|"3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337615|NCT03589807|FG001|Participant Flow|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|"3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337616|NCT03589807|FG002|Participant Flow|"2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|"3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337617|NCT03589807|FG003|Participant Flow|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|"3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337618|NCT03589807|FG004|Participant Flow|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|"3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337619|NCT03589807|FG005|Participant Flow|"2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|"3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.~A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).~AS03: Oil-in-water emulsion adjuvant.~Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine."
11337620|NCT03589807|OG000|Outcome|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
11337621|NCT03589807|OG001|Outcome|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
11337622|NCT03589807|OG002|Outcome|"2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
11337623|NCT03589807|OG003|Outcome|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
11337624|NCT03589807|OG004|Outcome|"2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
11337625|NCT03589807|OG005|Outcome|"2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)"|3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
11337626|NCT03589807|OG000|Outcome|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 22.
11337627|NCT03589807|OG001|Outcome|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + ASO3 adjuvant administered intramuscularly on Day 121.
11337628|NCT03589807|OG000|Outcome|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
11337629|NCT03589807|EG000|Reported Event|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)"|3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
11337630|NCT03589807|EG001|Reported Event|"2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)"|3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
11337949|NCT03597178|OG000|Outcome|Senofilcon A|Subjects that inserted and removed the senofilcon A lens.
11337772|NCT03593902|BG000|Baseline|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Fludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~rATG: A rabbit polyclonal antibody to lymphocytes~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and"
11337773|NCT03593902|FG000|Participant Flow|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Fludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~rATG: A rabbit polyclonal antibody to lymphocytes~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and"
11337774|NCT03593902|OG000|Outcome|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Fludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~rATG: A rabbit polyclonal antibody to lymphocytes~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and"
11337775|NCT03593902|EG000|Reported Event|Hematopoietic Stem Cell Transplantation|"Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.~Rituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer~Fludarabine: A chemotherapy medication commonly used in the treatment of leukemia & lymphoma~Cyclophosphamide: A medication used as chemotherapy and to suppress the immune system~Mesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder~rATG: A rabbit polyclonal antibody to lymphocytes~Methylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation~G-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and"
11337776|NCT03594045|BG000|Baseline|Apixaban for HIT|"Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337777|NCT03594045|BG001|Baseline|Apixaban for HITT|"Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337778|NCT03594045|BG002|Baseline|Total|Total of all reporting groups
11337779|NCT03594045|FG000|Participant Flow|Apixaban for HIT|"Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337780|NCT03594045|FG001|Participant Flow|Apixaban for HITT|"Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337781|NCT03594045|OG000|Outcome|Apixaban for HIT|"Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337782|NCT03594045|OG001|Outcome|Apixaban for HITT|"Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337783|NCT03594045|EG000|Reported Event|Apixaban for HIT|"Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337784|NCT03594045|EG001|Reported Event|Apixaban for HITT|"Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.~Apixaban: Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa."
11337785|NCT03594071|BG000|Baseline|Safety Population|All subjects enrolled into the study
11337786|NCT03594071|FG000|Participant Flow|Safety Population|All subjects enrolled into the study
11337787|NCT03594071|OG000|Outcome|Safety Population|All subjects enrolled into the study
11337788|NCT03594071|EG000|Reported Event|Safety Population|All subjects enrolled into the study
11337929|NCT03597061|BG000|Baseline|Healthy Start to Feeding Intervention|"Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.~Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."
11337930|NCT03597061|BG001|Baseline|Control|Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
11337931|NCT03597061|BG002|Baseline|Total|Total of all reporting groups
11337932|NCT03597061|FG000|Participant Flow|Control|Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
11337933|NCT03597061|FG001|Participant Flow|Healthy Start to Feeding Intervention|"Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.~Healthy Start to Feeding: The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."
11337934|NCT03597061|OG000|Outcome|Healthy Start to Feeding Intervention|"Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.~Healthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."
11337935|NCT03597061|OG001|Outcome|Control|Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.
11337936|NCT03597061|EG000|Reported Event|Healthy Start to Feeding Intervention|"Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.~Healthy Start to Feeding: The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."
11337937|NCT03597061|EG001|Reported Event|Control|Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
11337938|NCT03597139|BG000|Baseline|Voclosporin Ophthalmic Solution (VOS)|"0.2% VOS, Twice Daily (BID), both eyes for 28 days~Voclosporin Ophthalmic Solution: Investigational Drug"
11337939|NCT03597139|BG001|Baseline|Comparator|"0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days~Restasis®: Comparator"
11337940|NCT03597139|BG002|Baseline|Total|Total of all reporting groups
11337941|NCT03597139|FG000|Participant Flow|Voclosporin Ophthalmic Solution (VOS)|"0.2% VOS, Twice Daily (BID), both eyes for 28 days~Voclosporin Ophthalmic Solution: Investigational Drug"
11337942|NCT03597139|FG001|Participant Flow|Comparator|"0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days~Restasis®: Comparator"
11337943|NCT03597139|OG000|Outcome|Voclosporin Ophthalmic Solution (VOS)|"0.2% VOS, Twice Daily (BID), both eyes for 28 days~Voclosporin Ophthalmic Solution: Investigational Drug"
11337944|NCT03597139|OG001|Outcome|Comparator|"0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days~Restasis®: Comparator"
11337945|NCT03597139|EG000|Reported Event|Voclosporin Ophthalmic Solution (VOS)|"0.2% VOS, Twice Daily (BID), both eyes for 28 days~Voclosporin Ophthalmic Solution: Investigational Drug"
11337946|NCT03597139|EG001|Reported Event|Comparator|"0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days~Restasis®: Comparator"
11337947|NCT03597178|BG000|Baseline|All Dispensed Subjects|All subjects dispensed a study lens.
11337948|NCT03597178|FG000|Participant Flow|Senofilcon A|Subjects that wore senofilcon A during the entire duration of the study
11337991|NCT03598647|EG003|Reported Event|Affect and Physical Activity|"Non-exercisers randomized to this condition will receive the same basic information about physical activity as described above, but they will also receive a brief intervention focused on affective responses to exercise.~Affect and physical activity: The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity."
11337992|NCT03599089|BG000|Baseline|CA-008 0.7 mg (0.05 mg/mL Concentration)|"Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337993|NCT03599089|BG001|Baseline|CA-008 2.1 mg (0.15 mg/mL Concentration)|"Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337994|NCT03599089|BG002|Baseline|CA-008 4.2 mg (0.3 mg/mL Concentration)|"Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337995|NCT03599089|BG003|Baseline|Placebo|"Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~Placebo: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337996|NCT03599089|BG004|Baseline|Total|Total of all reporting groups
11337997|NCT03599089|FG000|Participant Flow|CA-008 0.7 mg (0.05 mg/mL Concentration)|"Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337998|NCT03599089|FG001|Participant Flow|CA-008 2.1 mg (0.15 mg/mL Concentration)|"Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11337999|NCT03599089|FG002|Participant Flow|CA-008 4.2 mg (0.3 mg/mL Concentration)|"Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338000|NCT03599089|FG003|Participant Flow|Placebo|"Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~Placebo: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338001|NCT03599089|OG000|Outcome|CA-008 0.7 mg (0.05 mg/mL Concentration)|"Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338002|NCT03599089|OG001|Outcome|CA-008 2.1 mg (0.15 mg/mL Concentration)|"Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338003|NCT03599089|OG002|Outcome|CA-008 4.2 mg (0.3 mg/mL Concentration)|"Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.~CA-008: single-dose wound infiltration prior to surgical incision closure~Ketorolac: 30mg IV administered intraoperatively~Acetaminophen: 1000mg IV administered intraoperatively~Oxycodone: 5mg PO prn post-surgery~Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery"
11338066|NCT03600376|BG001|Baseline|Standard of Care Only (SOC)|"Standard of Care treatment will consist of the immediate start of cooling measures.~Standard of Care: Body cooling measures and supportive measures"
11338067|NCT03600376|BG002|Baseline|Total|Total of all reporting groups
11338057|NCT03600194|OG001|Outcome|PowerSleep Sham|"This PowerSleep Sham device is the same as the PowerSleep Stim device, however, it can be configured in a mode that does not play audio tones~PowerSleep Sham: The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time."
11338058|NCT03600194|OG002|Outcome|Northwestern Stim|"The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used.~Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals."
11338059|NCT03600194|OG003|Outcome|Northwestern Sham|"The Northwestern Sham device will be the same as the Northwestern Stim set up, however no audio tones will be played.~NorthWestern Sham: The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition."
11338060|NCT03600194|EG000|Reported Event|Screening Population|All participants that were consented.
11338061|NCT03600194|EG001|Reported Event|PowerSleep Stim|"In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device.~PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time."
11338062|NCT03600194|EG002|Reported Event|PowerSleep Sham|"This PowerSleep Sham device is the same as the PowerSleep Stim device, however, it can be configured in a mode that does not play audio tones~PowerSleep Sham: The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time."
11338063|NCT03600194|EG003|Reported Event|Northwestern Stim|"The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used.~Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals."
11338064|NCT03600194|EG004|Reported Event|Northwestern Sham|"The Northwestern Sham device will be the same as the Northwestern Stim set up, however no audio tones will be played.~NorthWestern Sham: The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition."
11338065|NCT03600376|BG000|Baseline|Ryanodex and Standard of Care|"In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.~Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push"
11338498|NCT03611829|OG000|Outcome|ACT Intervention|Physician treatment satisfaction for the ACT intervention.
11338477|NCT03611582|EG000|Reported Event|Semaglutide 2.4 mg|Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.
11338478|NCT03611582|EG001|Reported Event|Placebo|Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
11338479|NCT03611777|BG000|Baseline|COPD Patients Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
11338480|NCT03611777|BG001|Baseline|COPD Patients Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
11338481|NCT03611777|BG002|Baseline|Total|Total of all reporting groups
11338482|NCT03611777|FG000|Participant Flow|COPD Patients Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
11338483|NCT03611777|FG001|Participant Flow|COPD Patients Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
11338484|NCT03611777|OG000|Outcome|COPD Patients Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
11338485|NCT03611777|OG000|Outcome|COPD Patients Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
11338486|NCT03611777|OG001|Outcome|COPD Patients Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
11338487|NCT03611777|OG001|Outcome|COPD Patients Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
11338488|NCT03611777|OG000|Outcome|Patients With COPD - Overall|Patients with chronic obstructive pulmonary disease (COPD), with or without current treatment of Inhaled CorticoSteroids (ICS) at study visit.
11338489|NCT03611777|OG001|Outcome|COPD Patients Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
11338490|NCT03611777|EG000|Reported Event|COPD Patients Treated or Not Treated With ICS at Study Visit|Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated or not treated with Inhaled CorticoSteroids (ICS).
11338491|NCT03611829|BG000|Baseline|Standard Care|"Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating.~Standard Care"
11338492|NCT03611829|BG001|Baseline|ACT Intervention|"In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week.~ACT Intervention~Standard Care"
11338493|NCT03611829|BG002|Baseline|Total|Total of all reporting groups
11338494|NCT03611829|FG000|Participant Flow|Standard Care|"Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating.~Standard Care"
11338495|NCT03611829|FG001|Participant Flow|ACT Intervention|"In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week.~ACT Intervention~Standard Care"
11338496|NCT03611829|OG000|Outcome|Standard Care|"Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating.~Standard Care"
11338497|NCT03611829|OG001|Outcome|ACT Intervention|"In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week.~ACT Intervention~Standard Care"
11338546|NCT03613649|BG000|Baseline|2g Zoliflodacin, 4g Zoliflodacin, Placebo, 400mg Moxifloxacin|"Treatment ABCD: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338547|NCT03613649|BG001|Baseline|2g Zoliflodacin, Placebo, 400mg Moxifloxacin, 4g Zoliflodacin|"Treatment ACDB: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out, 400 mg moxifloxacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water.."
11338548|NCT03613649|BG002|Baseline|2g Zoliflodacin, 400mg Moxifloxacin, 4g Zoliflodacin, Placebo|"Treatment ADBC: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 4g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338549|NCT03613649|BG003|Baseline|4g Zoliflodacin, 2g Zoliflodacin, 400mg Moxifloxacin, Placebo|"Treatment BADC: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out2 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338550|NCT03613649|BG004|Baseline|4g Zoliflodacin, 400mg Moxifloxacin, Placebo, 2g Zoliflodacin,|"Treatment BDCA: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338551|NCT03613649|BG005|Baseline|4g Zoliflodacin, Placebo, 2g Zoliflodacin, 400mg Moxifloxacin|"Treatment BCAD: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338552|NCT03613649|BG006|Baseline|Placebo, 400mg Moxifloxacin, 2g Zoliflodacin, 4g Zoliflodacin,|"Treatment CDAB: Placebo administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338656|NCT03615079|OG000|Outcome|Cognitive Behavioral Therapy (CBT) Program|Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
11338553|NCT03613649|BG007|Baseline|Placebo, 2g Zoliflodacin, 4g Zoliflodacin, 400mg Moxifloxacin|"Treatment CABD: Placebo administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338554|NCT03613649|BG008|Baseline|Placebo, 4g Zoliflodacin, 400mg Moxifloxacin, 2g Zoliflodacin|"Treatment CBDA: Placebo administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338555|NCT03613649|BG009|Baseline|400mg Moxifloxacin, Placebo, 4g Zoliflodacin, 2g Zoliflodacin|"Treatment DCBA: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338556|NCT03613649|BG010|Baseline|400mg Moxifloxacin, 4g Zoliflodacin, 2g Zoliflodacin, Placebo|"Treatment DBAC: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338557|NCT03613649|BG011|Baseline|400mg Moxifloxacin, 2g Zoliflodacin, Placebo, 4g Zoliflodacin|"Treatment DACB: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338558|NCT03613649|BG012|Baseline|Total|Total of all reporting groups
11338559|NCT03613649|FG000|Participant Flow|2g Zoliflodacin, 4g Zoliflodacin, Placebo, 400mg Moxifloxacin|"Treatment ABCD: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338560|NCT03613649|FG001|Participant Flow|2g Zoliflodacin, Placebo, 400mg Moxifloxacin, 4g Zoliflodacin|"Treatment ACDB: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out, 400 mg moxifloxacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338657|NCT03615079|EG000|Reported Event|Cognitive Behavioral Therapy (CBT) Program|Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
11338561|NCT03613649|FG002|Participant Flow|2g Zoliflodacin, 400mg Moxifloxacin, 4g Zoliflodacin, Placebo|"Treatment ADBC: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 4g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338562|NCT03613649|FG003|Participant Flow|4g Zoliflodacin, 2g Zoliflodacin, 400mg Moxifloxacin, Placebo|"Treatment BADC: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338563|NCT03613649|FG004|Participant Flow|4g Zoliflodacin, 400mg Moxifloxacin, Placebo, 2g Zoliflodacin,|"Treatment BDCA: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338564|NCT03613649|FG005|Participant Flow|4g Zoliflodacin, Placebo, 2g Zoliflodacin, 400mg Moxifloxacin|"Treatment BCAD: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338565|NCT03613649|FG006|Participant Flow|Placebo, 400mg Moxifloxacin, 2g Zoliflodacin, 4g Zoliflodacin,|"Treatment CDAB: Placebo administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338566|NCT03613649|FG007|Participant Flow|Placebo, 2g Zoliflodacin, 4g Zoliflodacin, 400mg Moxifloxacin|"Treatment CABD: Placebo administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338567|NCT03613649|FG008|Participant Flow|Placebo, 4g Zoliflodacin, 400mg Moxifloxacin, 2g Zoliflodacin|"Treatment CBDA: Placebo administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338586|NCT03613649|EG003|Reported Event|400 mg of Moxifloxacin|"400 mg of moxifloxacin administered orally on Day 1 of each dosing period~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338658|NCT03615183|BG000|Baseline|Panel A: MK-8527 10 mg|Single oral dose of 10 mg MK-8527 in capsule form after an 8-hour fast
11338568|NCT03613649|FG009|Participant Flow|400mg Moxifloxacin, Placebo, 4g Zoliflodacin, 2g Zoliflodacin|"Treatment DCBA: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338569|NCT03613649|FG010|Participant Flow|400mg Moxifloxacin, 4g Zoliflodacin, 2g Zoliflodacin, Placebo|"Treatment DBAC: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338570|NCT03613649|FG011|Participant Flow|400mg Moxifloxacin, 2g Zoliflodacin, Placebo, 4g Zoliflodacin|"Treatment DACB: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken.~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject.~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338571|NCT03613649|OG000|Outcome|2 g of Zoliflodacin|2 g of zoliflodacin administered orally on Day 1 of dosing period.
11338572|NCT03613649|OG001|Outcome|4 g of Zoliflodacin|4 g of zoliflodacin administered orally on Day 1 of dosing period.
11338573|NCT03613649|OG002|Outcome|Placebo|Placebo was administered orally on Day 1 of dosing period.
11338574|NCT03613649|OG000|Outcome|400 mg of Moxifloxacin|400 mg of moxifloxacin administered orally on Day 1 of dosing period.
11338575|NCT03613649|OG001|Outcome|Placebo|Placebo administered orally on Day 1 of dosing period.
11338576|NCT03613649|OG000|Outcome|Placebo|"Placebo for zoliflodacin administered orally on Day 1 of each dosing period~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose."
11338577|NCT03613649|OG001|Outcome|2 g of Zoliflodacin|"2 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338578|NCT03613649|OG002|Outcome|4 g of Zoliflodacin|"4 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338579|NCT03613649|OG003|Outcome|400 mg of Moxifloxacin|"400 mg of moxifloxacin administered orally on Day 1 of each dosing period~Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water."
11338580|NCT03613649|OG000|Outcome|2 g of Zoliflodacin|"2 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338581|NCT03613649|OG001|Outcome|4 g of Zoliflodacin|"4 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338582|NCT03613649|OG002|Outcome|Placebo|"Placebo for zoliflodacin administered orally on Day 1 of each dosing period~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose."
11338583|NCT03613649|EG000|Reported Event|2 g of Zoliflodacin|"2 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338584|NCT03613649|EG001|Reported Event|4 g of Zoliflodacin|"4 g of zoliflodacin administered orally on Day 1 of each dosing period~AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject."
11338585|NCT03613649|EG002|Reported Event|Placebo|"Placebo for zoliflodacin administered orally on Day 1 of each dosing period~Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose."
11338638|NCT03614416|OG000|Outcome|EOXY Device and Gold Standard Oximter and SaO2 Measures|"SPO2 measures provided from EOXY device SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11338639|NCT03614416|OG000|Outcome|EOXY Device and Gold Standard Oximeter and SaO2 Measures|"SPO2 measures provided from EOXY device SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11338640|NCT03614416|EG000|Reported Event|EOXY Device and Gold Standard Oximeter and SaO2 Measures|"Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter~EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard~SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard"
11338641|NCT03614975|BG000|Baseline|Flucelvax Inactivated Influenza Vaccine|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338642|NCT03614975|BG001|Baseline|Fluzone Inactivated Influenza Vaccine|"Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly~Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338643|NCT03614975|BG002|Baseline|Total|Total of all reporting groups
11338644|NCT03614975|FG000|Participant Flow|Flucelvax Inactivated Influenza Vaccine|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338645|NCT03614975|FG001|Participant Flow|Fluzone Inactivated Influenza Vaccine|"Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly~Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338646|NCT03614975|OG000|Outcome|Flucelvax Inactivated Influenza Vaccine|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338647|NCT03614975|OG001|Outcome|Fluzone Inactivated Influenza Vaccine|"Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly~Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338648|NCT03614975|EG000|Reported Event|Flucelvax Inactivated Influenza Vaccine|"Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly~Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338649|NCT03614975|EG001|Reported Event|Fluzone Inactivated Influenza Vaccine|"Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly~Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)"
11338650|NCT03615001|BG000|Baseline|Urodynamics Arm|TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
11338651|NCT03615001|FG000|Participant Flow|Urodynamics Arm|Urodynamic testing and data collection (per protocol) using the TDOC NXT catheters
11338652|NCT03615001|OG000|Outcome|Urodynamics Arm|TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
11338653|NCT03615001|EG000|Reported Event|Urodynamics Arm|TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
11338654|NCT03615079|BG000|Baseline|Cognitive Behavioral Therapy (CBT) Program|Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
11338655|NCT03615079|FG000|Participant Flow|Cognitive Behavioral Therapy (CBT) Program|Cognitive behavioral therapy: An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
11338871|NCT03618823|OG000|Outcome|Opioid Pain Control Group|"Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.~Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338872|NCT03618823|OG001|Outcome|Non-opioid Pain Control Group|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338873|NCT03618823|OG000|Outcome|Opioid Pain Control|"Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.~Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338874|NCT03618823|OG001|Outcome|Non-opioid Pain Control|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338875|NCT03618823|OG000|Outcome|Non-opioid Pain Control|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338876|NCT03618823|EG000|Reported Event|Opioid Pain Control|"Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.~Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11339132|NCT03626415|OG000|Outcome|PF-04965842 (Normal Hepatic Function Cohort)|Participants with normal hepatic function were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339309|NCT03628599|FG001|Participant Flow|1-DAY|Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
11338877|NCT03618823|EG001|Reported Event|Non-opioid Pain Control|"Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.~Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.~Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours."
11338878|NCT03619135|BG000|Baseline|Use of Buzzy Device|"The Buzzy device was used for IV access for this arm.~Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults."
11338879|NCT03619135|BG001|Baseline|Control|"No Buzzy device was used - standard IV access for this arm.~Placebo: No use of the Buzzy (standard IV access techniques)"
11338880|NCT03619135|BG002|Baseline|Total|Total of all reporting groups
11338881|NCT03619135|FG000|Participant Flow|Use of Buzzy Device|"The Buzzy device was used for IV access for this arm.~Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults."
11338882|NCT03619135|FG001|Participant Flow|Control|"No Buzzy device was used - standard IV access for this arm.~Placebo: No use of the Buzzy (standard IV access techniques)"
11338883|NCT03619135|OG000|Outcome|Use of Buzzy Device|"The Buzzy device was used for IV access for this arm.~Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults."
11338884|NCT03619135|OG001|Outcome|Control|"No Buzzy device was used - standard IV access for this arm.~Placebo: No use of the Buzzy (standard IV access techniques)"
11338885|NCT03619135|EG000|Reported Event|Use of Buzzy Device|"The Buzzy device was used for IV access for this arm.~Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults."
11338886|NCT03619135|EG001|Reported Event|Control|"No Buzzy device was used - standard IV access for this arm.~Placebo: No use of the Buzzy (standard IV access techniques)"
11338887|NCT03619590|BG000|Baseline|Exposure Group|Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
11338888|NCT03619590|FG000|Participant Flow|Exposure Group|Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
11338889|NCT03619590|OG000|Outcome|Exposure Group|Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
11338890|NCT03619590|EG000|Reported Event|Exposure Group|Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
11338891|NCT03619811|BG000|Baseline|Symptomatic|"This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)~Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms."
11338892|NCT03619811|FG000|Participant Flow|Symptomatic|"This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)~Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms."
11338893|NCT03619811|OG000|Outcome|Symptomatic|"This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)~Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms."
11339133|NCT03626415|OG001|Outcome|PF-04965842 (Mild Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339116|NCT03624972|FG001|Participant Flow|Resources + Video|"Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called Starting the Conversation and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.~Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339117|NCT03624972|FG002|Participant Flow|Clinician Arm|Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data were not collected from clinician participants.
11339118|NCT03624972|OG000|Outcome|Resources Only|"Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339119|NCT03624972|OG001|Outcome|Resources + Video|"Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called Starting the Conversation and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.~Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339120|NCT03624972|OG000|Outcome|All Participants|Recruitment rates are calculated for all potential study candidates.
11339121|NCT03624972|OG000|Outcome|Resources + Video Group Only|"Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called Starting the Conversation and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.~Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339122|NCT03624972|EG000|Reported Event|Resources Only|"Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339123|NCT03624972|EG001|Reported Event|Resources + Video|"Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called Starting the Conversation and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.~Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.~Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic."
11339124|NCT03624972|EG002|Reported Event|Clinician Arm|Clinicians were consented in order to have their clinic visits audio recorded.
11339125|NCT03626415|BG000|Baseline|PF-04965842 (Normal Hepatic Function Cohort)|Participants with normal hepatic function were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339126|NCT03626415|BG001|Baseline|PF-04965842 (Mild Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339127|NCT03626415|BG002|Baseline|PF-04965842 (Moderate Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339128|NCT03626415|BG003|Baseline|Total|Total of all reporting groups
11339129|NCT03626415|FG000|Participant Flow|PF-04965842 (Normal Hepatic Function Cohort)|Participants with normal hepatic function were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339130|NCT03626415|FG001|Participant Flow|PF-04965842 (Mild Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339131|NCT03626415|FG002|Participant Flow|PF-04965842 (Moderate Hepatic Impairment Cohort)|Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received a single oral dose of PF-04965842 200 mg.
11339305|NCT03628599|BG000|Baseline|TOTAL1|Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
11339259|NCT03627767|FG000|Participant Flow|PF-04965842 200 mg OL|Participants received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 once daily (QD) during an OL run-in period. Responders at the end of the 12-week OL run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator's Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an Eczema Area and Severity Index (EASI)-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339260|NCT03627767|FG001|Participant Flow|PF-04965842 200 mg OL to Placebo DB|Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339261|NCT03627767|FG002|Participant Flow|PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB|Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339262|NCT03627767|FG003|Participant Flow|PF-04965842 200 mg OL to PF-04965842 200 mg DB|Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339263|NCT03627767|FG004|Participant Flow|PF-04965842 200 mg Rescue Period|Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
11339264|NCT03627767|OG000|Outcome|PF-04965842 200 mg OL to Placebo DB|Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339265|NCT03627767|OG001|Outcome|PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB|Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339266|NCT03627767|OG002|Outcome|PF-04965842 200 mg OL to PF-04965842 200 mg DB|Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339267|NCT03627767|OG000|Outcome|PF-04965842 200 mg Rescue Period|Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
11339268|NCT03627767|EG000|Reported Event|PF-04965842 200 mg OL|Participants received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 weeks, DB, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of >= 2 points, and c) reaching an EASI-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339269|NCT03627767|EG001|Reported Event|PF-04965842 200 mg OL to Placebo DB|Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
11339306|NCT03628599|BG001|Baseline|1-DAY|Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
11339307|NCT03628599|BG002|Baseline|Total|Total of all reporting groups
11339308|NCT03628599|FG000|Participant Flow|TOTAL1|Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
11339284|NCT03628417|FG001|Participant Flow|Bleomycin Based Electrochemotherapy|"Both dose and volume of bleomycin (1000 IU/ml) was standard according to ESOPE.~Tumor < 0.5 cm³ - 1 ml/cm³ tumor volume~Tumor > 0.5 cm³ - 0,5 ml/cm³ tumor volume Tumor volume = ab²π/6 (a = longest diameter, b = longest diameter perpendicular to a) Maximum of injected bleomycin per tumor was 1500 IU and total dose per treatment was 7500 IU.~Biopsies were performed from the tumor area before and after electroporation. Maximum of 8 biopsies were done, depending on the patient's number of metastases. All patient's regardless of the number of metastases had one biopsy from area treated with bleomycin and one from area treated with calcium, after the randomization code was revealed at day 180.~All biopsies will be handled according to current guidelines and analyzed by a pathologist."
11339285|NCT03628417|OG000|Outcome|Calcium Electroporation|"Volume of calcium chloride (220 mmol/L) was dependent on the tumor volume. Smaller tumors should have bigger volume per cm3, as smaller tumors were expected to have a bigger loss of injected medicine into the surrounding tissue. The dose volume was calculated according to the 'European Standard Operating Procedure of the Electrochemotherapi (ESOPE)'.~Tumor < 0.5 cm³ - 1 ml/cm³ tumor volume~Tumor > 0.5 cm³ - 0,5 ml/cm³ tumor volume Tumor volume = ab²π/6 (a = longest diameter, b = longest diameter perpendicular to a)~All patient's regardless of the number of metastases have had one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.~All biopsies were handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."
11339286|NCT03628417|OG001|Outcome|Bleomycin Based Electrochemotherapy|"Both dose and volume of bleomycin (1000 IU/ml) is standard according to ESOPE.~Tumor < 0.5 cm³ - 1 ml/cm³ tumor volume~Tumor > 0.5 cm³ - 0,5 ml/cm³ tumor volume Tumor volume = ab²π/6 (a = longest diameter, b = longest diameter perpendicular to a)~Maximum of injected bleomycin per tumor was1500 IU and total dose per treatment 7500 IU. Normal maximum limit for bleomycin was 15.000 IU/m² body surface area.~All patient's regardless of the number of metastases have had one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.~All biopsies were handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."
11339287|NCT03628417|OG000|Outcome|Calcium Electroporation|Experiences from treating small tumors with electrochemotherapy, show that the treated area initially can become erythmatose and swollen, but this fades quickly. The area can then become necrotic which heals within 6-10 weeks. In a few cases, infection may occur in the treatment area. With calcium electroporation we expect to see the same response to treatment.
11339288|NCT03628417|OG001|Outcome|Bleomycin Based Electrochemotherapy|At electrochemotherapy the most reported adverse events are pain after the procedure and flu-like symptoms. The latter is a reaction to bleomycin and is therefore not expected by calcium electroporation.
11339289|NCT03628417|OG000|Outcome|Calcium Electroporation|"Calcium electroporation is a local treatment where calcium is administered intratumoral and followed by electrical pulses applied on the tumor. Volume of calcium chloride (220 mmol/L) was dependent on tumor volume which was calculated according to the 'European Standard Operating Procedure of the Electrochemotherapy' (ESOPE).~Calcium chloride 220 mmol/L (9 mg/ml):~Tumor < 0,5 cm3 - 1 ml / cm3 tumor volume~Tumor >0,5 cm3 - 0,5 ml/ cm3 tumor volume Tumor volume = ab2π/6 (a=longest diameter, b= longest diameter perpendicular to a)"
11339290|NCT03628417|OG001|Outcome|Bleomycin Based Electrochemotherapy|"Electroporation is a method that can facilitate transport of molecules across the cell membrane and into the cell by means of electrical pulses. The method can be used with molecules that normally have difficulty passing the cell membrane such as chemotherapy (electrochemotherapy).The most used chemotherapeutic drug used in electrochemotherapy is bleomycin (1000 IU/ml). Both dose and volume of bleomycin is standard according to ESOPE.~Bleomycin 1000 IU/ml:~Tumor < 0.5 cm³ - 1 ml/cm³ tumor volume~Tumor > 0.5 cm³ - 0,5 ml/cm³ tumor volume Tumor volume = ab²π/6 (a = longest diameter, b = longest diameter perpendicular to a)~Maximum of injected bleomycin per tumor was 1500 IU and total dose per treatment was 7500 IU."
11339291|NCT03628417|EG000|Reported Event|Calcium Electroporation|Experiences from treating small tumors with electrochemotherapy, show that the treated area initially can become erythmatose and swollen, but this fades quickly. The area can then become necrotic which heals within 6-10 weeks. In a few cases, infection may occur in the treatment area. With calcium electroporation we expect to see the same response to treatment.
11339292|NCT03628417|EG001|Reported Event|Bleomycin Based Electrochemotherapy|At electrochemotherapy the most reported adverse events are pain after the procedure and flu-like symptoms. The latter is a reaction to bleomycin and is therefore not expected by calcium electroporation.
11339293|NCT03628456|BG000|Baseline|AffloVest Monarch Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Hill-Rom Monarch: High-frequency chest wall oscillation vest"
11339294|NCT03628456|FG000|Participant Flow|AffloVest Monarch Arm|"Devices placed on highest intensity / highest frequency~International Biophysics AffloVest: High-frequency chest wall oscillation vest~Hill-Rom Monarch: High-frequency chest wall oscillation vest"
11339295|NCT03628456|OG000|Outcome|Baseline|Patient baseline result
11339296|NCT03628456|OG001|Outcome|AffloVest Arm|AffloVest placed on subject at highest intensity for five (5) minutes
11339297|NCT03628456|OG002|Outcome|Monarch Arm|Monarch placed on subject at highest intensity for five (5) minutes
11339298|NCT03628456|EG000|Reported Event|Baseline|Patient baseline result
11339299|NCT03628456|EG001|Reported Event|AffloVest Arm|AffloVest placed on highest intensity
11339300|NCT03628456|EG002|Reported Event|Monarch Arm|Monarch placed on highest intensity
11339301|NCT03628508|BG000|Baseline|Exercise|"Six-week exercise including stretching, strengthening, endurance and gait modification~Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc."
11339302|NCT03628508|FG000|Participant Flow|Exercise|"Six-week exercise including stretching, strengthening, endurance and gait modification~Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc."
11339303|NCT03628508|OG000|Outcome|Exercise|"Six-week exercise including stretching, strengthening, endurance and gait modification~Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc."
11339304|NCT03628508|EG000|Reported Event|Exercise|"Six-week exercise including stretching, strengthening, endurance and gait modification~Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc."
11339329|NCT03628885|EG001|Reported Event|Top Concern Tailored Intervention|"Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above. For those indicating #6, they will receive the same video as those indicating #1 (need more information).~Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns."
11339330|NCT03628885|EG002|Reported Event|All Concerns Tailored Intervention|"Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above.~All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns."
11339331|NCT03628898|BG000|Baseline|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor~INVSENSOR00025: Noninvasive pulse oximeter sensor"
11339332|NCT03628898|FG000|Participant Flow|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor~INVSENSOR00025: Noninvasive pulse oximeter sensor"
11339333|NCT03628898|OG000|Outcome|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor~INVSENSOR00025: Noninvasive pulse oximeter sensor"
11339334|NCT03628898|EG000|Reported Event|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor~INVSENSOR00025: Noninvasive pulse oximeter sensor"
11339335|NCT03628924|BG000|Baseline|Placebo (Week 0 - 16)|Participants received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.
11339336|NCT03628924|BG001|Baseline|Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)|Participants received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.
11339337|NCT03628924|BG002|Baseline|Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)|Participants received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
11339338|NCT03628924|BG003|Baseline|Total|Total of all reporting groups
11339339|NCT03628924|FG000|Participant Flow|Placebo (Week 0 - 16)|Participants received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.
11339340|NCT03628924|FG001|Participant Flow|Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)|Participants received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.
11339341|NCT03628924|FG002|Participant Flow|Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)|Participants received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
11339342|NCT03628924|FG003|Participant Flow|Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)|At Week 16, participants receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32. All participants entered safety follow-up at Week 36 through Week 48.
11339343|NCT03628924|FG004|Participant Flow|Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)|At Week 16, participants receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339344|NCT03628924|FG005|Participant Flow|Guselkumab 200 mg SC (Week 16 - 48)|Participants who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339345|NCT03628924|FG006|Participant Flow|Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)|Participants who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339346|NCT03628924|OG000|Outcome|Placebo (Week 0 - 16)|Participants received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.
11339347|NCT03628924|OG001|Outcome|Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)|Participants received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.
11339348|NCT03628924|OG002|Outcome|Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)|Participants received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
11339349|NCT03628924|EG000|Reported Event|Placebo (Week 0 - 16)|Participants received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.
11339350|NCT03628924|EG001|Reported Event|Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)|Participants received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.
11339351|NCT03628924|EG002|Reported Event|Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)|Participants received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
11339352|NCT03628924|EG003|Reported Event|Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)|At Week 16, participants receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32. All participants entered safety follow-up at Week 36 through Week 48.
11339353|NCT03628924|EG004|Reported Event|Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)|At Week 16, participants receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339354|NCT03628924|EG005|Reported Event|Guselkumab 200 mg SC (Week 16 - 48)|Participants who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36. All participants entered safety follow-up at Week 36 through Week 48.
11339461|NCT03630185|EG000|Reported Event|Off-the-rack Stockings (Sigvaris)|"Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.~Off-the-rack stockings (Sigvaris): Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb."
11339462|NCT03630185|EG001|Reported Event|Custom-manufactured Compression Hosiery (Isobar)|"The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.~Custom-manufactured compression hosiery (Isobar): The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb."
11339463|NCT03630198|BG000|Baseline|Corticosteroid With Lidocaine|"This arm will include an injection mixture of corticosteroid and lidocaine~Corticosteroid with lidocaine: Intralesional corticosteroid injection"
11339464|NCT03630198|BG001|Baseline|Corticosteroid With Normal Saline|"This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Intralesional corticosteroid injection"
11339465|NCT03630198|BG002|Baseline|Total|Total of all reporting groups
11339466|NCT03630198|FG000|Participant Flow|Corticosteroid With Lidocaine|"This arm will include an injection mixture of corticosteroid and lidocaine~Corticosteroid with lidocaine: Intralesional corticosteroid injection"
11339467|NCT03630198|FG001|Participant Flow|Corticosteroid With Normal Saline|"This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Intralesional corticosteroid injection"
11339468|NCT03630198|OG000|Outcome|Corticosteroid With Lidocaine|"This arm will include an injection mixture of corticosteroid and lidocaine~Corticosteroid with lidocaine: Intralesional corticosteroid injection"
11339469|NCT03630198|OG001|Outcome|Corticosteroid With Normal Saline|"This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Intralesional corticosteroid injection"
11339470|NCT03630198|EG000|Reported Event|Corticosteroid With Lidocaine|"This arm will include an injection mixture of corticosteroid and lidocaine~Corticosteroid with lidocaine: Intralesional corticosteroid injection"
11339471|NCT03630198|EG001|Reported Event|Corticosteroid With Normal Saline|"This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.~Corticosteroid with normal saline: Intralesional corticosteroid injection"
11339472|NCT03630302|BG000|Baseline|All Patients|All patients underwent STN DBS implants
11339473|NCT03630302|FG000|Participant Flow|LFP Recording Patients|All patients underwent STN DBS implants. The DBS leads were programmed by clinicians at initial visit and symptoms re-evaluated at 3 month post-operative visit. Local field potentials (LFPs) were recorded from 9 patients during the surgery of DBS implants. Hardware issue prevented LFP recordings from 1 patient.
11339474|NCT03630302|OG000|Outcome|LFP Analyses From Patients With Bilateral Implants|all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained
11339475|NCT03630302|EG000|Reported Event|LFP Recording Patients|All patients underwent STN DBS implants, 9/10 patients obtained LFP recordings during surgery. The 9 patients were then revisited for 3 month post-op followup.
11339476|NCT03630679|BG000|Baseline|Preterm|born at <37 weeks of gestation
11339477|NCT03630679|BG001|Baseline|Full Term Term|born at >/= 37 weeks of gestation
11339478|NCT03630679|BG002|Baseline|Total|Total of all reporting groups
11339479|NCT03630679|FG000|Participant Flow|Preterm|born at <37 weeks of gestation
11339480|NCT03630679|FG001|Participant Flow|Full Term Term|born at >/= 37 weeks of gestation
11339481|NCT03630679|OG000|Outcome|Preterm|born at <37 weeks of gestation
11339482|NCT03630679|OG001|Outcome|Full Term Term|born at >/= 37 weeks of gestation
11339483|NCT03630679|EG000|Reported Event|Preterm|born at <37 weeks of gestation
11339484|NCT03630679|EG001|Reported Event|Full Term Term|born at >/= 37 weeks of gestation
11339485|NCT03631355|BG000|Baseline|ACL Reconstruction w/ BTB Autograft + IV TXA|Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
11339486|NCT03631355|BG001|Baseline|ACL Reconstruction w/ BTB Autograft, no IV TXA|Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
11339487|NCT03631355|BG002|Baseline|Total|Total of all reporting groups
11339488|NCT03631355|FG000|Participant Flow|ACL Reconstruction w/ BTB Autograft + IV TXA|Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
11339489|NCT03631355|FG001|Participant Flow|ACL Reconstruction w/ BTB Autograft, no IV TXA|Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
11339490|NCT03631355|OG000|Outcome|ACL Reconstruction w/ BTB Autograft + IV TXA|Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
11339491|NCT03631355|OG001|Outcome|ACL Reconstruction w/ BTB Autograft, no IV TXA|Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
11339492|NCT03631355|EG000|Reported Event|ACL Reconstruction w/ BTB Autograft + IV TXA|Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
11339493|NCT03631355|EG001|Reported Event|ACL Reconstruction w/ BTB Autograft, no IV TXA|Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
11340016|NCT03644108|OG000|Outcome|Mucinex® 600 mg ER|Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
11339621|NCT03634085|BG000|Baseline|Cohort A|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339622|NCT03634085|BG001|Baseline|Cohort B|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339623|NCT03634085|BG002|Baseline|Total|Total of all reporting groups
11339624|NCT03634085|FG000|Participant Flow|Cohort A|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339625|NCT03634085|FG001|Participant Flow|Cohort B|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339626|NCT03634085|OG000|Outcome|Cohort A|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339627|NCT03634085|OG001|Outcome|Cohort B|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339628|NCT03634085|EG000|Reported Event|Cohort A-placebo|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339629|NCT03634085|EG001|Reported Event|Cohort B-placebo|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339630|NCT03634085|EG002|Reported Event|Cohort A-50mg|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339631|NCT03634085|EG003|Reported Event|Cohort B-150mg|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339632|NCT03634085|EG004|Reported Event|Cohort A-450mg|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339633|NCT03634085|EG005|Reported Event|Cohort B-900mg Fasted|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339634|NCT03634085|EG006|Reported Event|Cohort A-1800mg|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339635|NCT03634085|EG007|Reported Event|Cohort B-900mg Fed|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339636|NCT03634085|EG008|Reported Event|Cohort A-3100mg|"Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.~The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.~BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration."
11339637|NCT03634306|BG000|Baseline|ARM 1|"Laparoscopic hysterectomy with use of the Ultravision System~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339638|NCT03634306|BG001|Baseline|ARM 2|"Laparoscopic Hysterectomy per Standard of Care/no Ultravision System~Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System"
11339639|NCT03634306|BG002|Baseline|ARM 3|"Laparoscopic myomectomy with use of the Ultravision System.~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339640|NCT03634306|BG003|Baseline|Total|Total of all reporting groups
11339641|NCT03634306|FG000|Participant Flow|ARM 1|"Laparoscopic hysterectomy with use of the Ultravision System~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339642|NCT03634306|FG001|Participant Flow|ARM 2|"Laparoscopic Hysterectomy per Standard of Care/no Ultravision System~Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System"
11339643|NCT03634306|FG002|Participant Flow|ARM 3|"Laparoscopic myomectomy with use of the Ultravision System.~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339644|NCT03634306|OG000|Outcome|ARM 1|"Laparoscopic hysterectomy with use of the Ultravision System~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11339645|NCT03634306|OG001|Outcome|ARM 2|"Laparoscopic Hysterectomy per Standard of Care/no Ultravision System~Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System"
11339646|NCT03634306|OG002|Outcome|ARM 3|"Laparoscopic myomectomy with use of the Ultravision System.~Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation."
11340017|NCT03644108|EG000|Reported Event|Mucinex® 600 mg ER|Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
11339654|NCT03634800|BG000|Baseline|Nivolumab/Radiotherapy|"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.~Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached~Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab~Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.~Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease."
11339655|NCT03634800|FG000|Participant Flow|Nivolumab/Radiotherapy|"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.~Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached~Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab~Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.~Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease."
11339656|NCT03634800|OG000|Outcome|Nivolumab/Radiotherapy|"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.~Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached~Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab~Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.~Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease."
11339657|NCT03634800|EG000|Reported Event|Nivolumab/Radiotherapy|"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.~Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached~Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab~Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.~Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease."
11339658|NCT03634813|BG000|Baseline|High Blood Pressure Monitoring and Counseling|"Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure, which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.~High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)"
11339659|NCT03634813|BG001|Baseline|Usual Care|"The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.~Usual Care: Usual Care"
11339660|NCT03634813|BG002|Baseline|Total|Total of all reporting groups
11339661|NCT03634813|FG000|Participant Flow|High Blood Pressure Monitoring and Counseling|"Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure, which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.~High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)"
11339662|NCT03634813|FG001|Participant Flow|Usual Care|"The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.~Usual Care: Usual Care"
11339663|NCT03634813|OG000|Outcome|High Blood Pressure Monitoring and Counseling|"Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called Your guide on lowering blood pressure, which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.~High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)"
11339755|NCT03636893|OG000|Outcome|FLOT Chemotherpy Regimen|"A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered~A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous~Repeated every 15th day~Three drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin"
11339741|NCT03636386|BG000|Baseline|Percutaneous Microelectrolysis Group (MEP)|"Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339742|NCT03636386|BG001|Baseline|Ultrasound Therapy|"Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339743|NCT03636386|BG002|Baseline|Total|Total of all reporting groups
11339744|NCT03636386|FG000|Participant Flow|Percutaneous Microelectrolysis Group (MEP)|"Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339745|NCT03636386|FG001|Participant Flow|Control Group (Ultrasound Therapy)|"Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339746|NCT03636386|OG000|Outcome|Percutaneous Microelectrolysis Group (MEP)|"Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339747|NCT03636386|OG001|Outcome|Control Group (Ultrasound Therapy)|"Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339748|NCT03636386|EG000|Reported Event|Percutaneous Microelectrolysis Group (MEP)|"Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339749|NCT03636386|EG001|Reported Event|Control Group (Ultrasound Therapy)|"Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.~Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes."
11339750|NCT03636893|BG000|Baseline|FLOT Chemotherpy Regimen|"A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered~A cycle consists of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous~Repeated every 15th day~Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin"
11339751|NCT03636893|BG001|Baseline|SOX Chemotherapy Regimen|"Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered~A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily)~Repeated every 21st day~Two drug Chemotherapy: Oxaliplatin+TGO"
11339752|NCT03636893|BG002|Baseline|Total|Total of all reporting groups
11339753|NCT03636893|FG000|Participant Flow|FLOT Chemotherpy Regimen|"A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered~A cycle consists of Day 1 5-fluorouracil (5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter (PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous~Repeated every 15th day~Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin"
11339754|NCT03636893|FG001|Participant Flow|SOX Chemotherapy Regimen|"Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered~A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily)~Repeated every 21st day~Two drug Chemotherapy: Oxaliplatin+TGO"
11339959|NCT03642873|OG000|Outcome|Treatment A (Reference) - Plasma Guaifenesin|Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state.
11340018|NCT03644173|BG000|Baseline|Personal Resilience Empowerment Program|Participants who were enrolled and attended at least one visit
11339947|NCT03642717|BG000|Baseline|JARDIANCE DUO® (Empagliflozin/Metformin)|All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
11339948|NCT03642717|FG000|Participant Flow|JARDIANCE DUO® (Empagliflozin/Metformin)|All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
11339949|NCT03642717|OG000|Outcome|JARDIANCE DUO® (Empagliflozin/Metformin)|All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
11339950|NCT03642717|OG000|Outcome|JARDIANCE DUO® (Empagliflozin/Metformin)|All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).
11339951|NCT03642717|EG000|Reported Event|JARDIANCE DUO® (Empagliflozin/Metformin)|All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
11339952|NCT03642873|BG000|Baseline|All Study Participants|"Participants were randomized at each visit to receive either~Treatment A (Reference): Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Treatment B (Reference): Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Treatment C (Test): Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses.~All study participants received all three treatments"
11339953|NCT03642873|FG000|Participant Flow|Sequence ABC|"First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended Release (ER) bi-layer tablet by mouth under fasted state~Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339954|NCT03642873|FG001|Participant Flow|Sequence ACB|"First Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339955|NCT03642873|FG002|Participant Flow|Sequence BAC|"First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Third Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339956|NCT03642873|FG003|Participant Flow|Sequence BCA|"First Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Second Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339957|NCT03642873|FG004|Participant Flow|Sequence CAB|"First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Second Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Third Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339958|NCT03642873|FG005|Participant Flow|Sequence CBA|"First Intervention Treatment C: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet and Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Second Intervention Treatment B: Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state~Third Intervention Treatment A: Single Humibid® 1200 mg guaifenesin Extended-Release (ER) bi-layer tablet by mouth under fasted state~Scheduled Washout of 7 days between each doses."
11339970|NCT03643432|BG001|Baseline|Exercise Adherence Intervention|"The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.~Exercise adherence intervention: Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders."
11339971|NCT03643432|BG002|Baseline|Total|Total of all reporting groups
11339972|NCT03643432|FG000|Participant Flow|Usual Care|"The usual care arm will consist of routine physiotherapy treatment, without the intervention.~Usual Care: Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm"
11339973|NCT03643432|FG001|Participant Flow|Exercise Adherence Intervention|"The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.~Exercise adherence intervention: Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders."
11339974|NCT03643432|OG000|Outcome|Usual Care|"The usual care arm will consist of routine physiotherapy treatment, without the intervention.~Usual Care: Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm"
11339975|NCT03643432|OG001|Outcome|Exercise Adherence Intervention|"The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.~Exercise adherence intervention: Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders."
11339976|NCT03643432|EG000|Reported Event|Usual Care|"The usual care arm will consist of routine physiotherapy treatment, without the intervention.~Usual Care: Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm"
11339977|NCT03643432|EG001|Reported Event|Exercise Adherence Intervention|"The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.~Exercise adherence intervention: Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders."
11339978|NCT03643575|BG000|Baseline|Overall Study|"Treatment A:~Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Treatment B:~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Treatment C:~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration~Participants randomized to receive either Treatment A or Treatment B or Treatment C in 3 Periods (Period 1, 2, 3) of 6 sequence (ABC, BCA, CAB, ACB, BAC, CBA)"
11339979|NCT03643575|FG000|Participant Flow|Treatment Sequence 1|"Period 1: Treatment A~Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment B~Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
11339980|NCT03643575|FG001|Participant Flow|Treatment Sequence 2|"Period 1: Treatment B~Robitussin Extra Strength 5ml syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 2: Treatment C~Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~Period 3: Treatment A~Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast~There was a 7 days washout period between each administration"
11340014|NCT03644108|BG000|Baseline|Mucinex® 600 mg ER|Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
11340015|NCT03644108|FG000|Participant Flow|Mucinex® 600 mg ER|Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
11339992|NCT03643692|FG000|Participant Flow|ARISES|ARISES: The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform. Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support. Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios. Ultimately, ARISES aims to empower self-management of chronic illness and limit the complic
11339993|NCT03643692|OG000|Outcome|ARISES|ARISES: The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform. Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support. Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios. Ultimately, ARISES aims to empower self-management of chronic illness and limit the complic
11339994|NCT03643692|EG000|Reported Event|ARISES|ARISES: The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform. Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support. Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios. Ultimately, ARISES aims to empower self-management of chronic illness and limit the complic
11339995|NCT03643952|BG000|Baseline|Daptomycin|Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia.
11339996|NCT03643952|FG000|Participant Flow|Daptomycin|Participants aged 1 to 17 years old with complicated skin and soft tissue infections (cSSTI) or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia.
11339997|NCT03643952|OG000|Outcome|Daptomycin|Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia.
11339998|NCT03643952|OG000|Outcome|Daptomycin (MRSA With cSSTI)|Participants aged 1 to 17 years old with cSSTI and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-14 days.
11339999|NCT03643952|OG001|Outcome|Daptomycin (MRSA With Bacteremia)|Participants aged 1 to 17 years old with bacteremia and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-42 days.
11340000|NCT03643952|OG000|Outcome|Daptomycin (MRSA With cSSTI)|Participants aged 1 to 17 years old with cSSTI and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-14 days
11340001|NCT03643952|OG001|Outcome|Daptomycin (MRSA With Bacteremia)|Participants aged 1 to 17 years old with bacteremia and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-42 days
11340002|NCT03643952|OG000|Outcome|Daptomycin (cSSTI)|Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days.
11340003|NCT03643952|OG001|Outcome|Daptomycin (Bacteremia)|Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days.
11340004|NCT03643952|OG000|Outcome|Daptomycin (cSSTI)|Participants diagnosed with cSSTI received daptomycin intravenously every 24 hours for 5-14 days.
11340005|NCT03643952|OG001|Outcome|Daptomycin (Bacterermia)|Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days.
11340006|NCT03643952|EG000|Reported Event|Daptomycin|Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia.
11340007|NCT03644095|BG000|Baseline|Overall Study|"Test (Treatment A): Subjects received a single PO (by mouth) dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.~Reference (Treatment B): Subjects received a single PO (by mouth) dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.~Period 1: Treatment A or Treatment B at Sequence AB~Period 2: Treatment B or Treatment A at Sequence BA~There was a 7 days washout period between each administration."
11340008|NCT03644095|FG000|Participant Flow|Mucinex First, Then Vicks|"Treatment Sequences 1: Treatment A in Period 1, then Treatment B in Period 2~Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.~Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.~There was a 7 days washout period between each administration."
11340009|NCT03644095|FG001|Participant Flow|Vicks First, Then Mucinex|"Treatment Sequences 2: Treatment B in Period 1, then Treatment A in Period 2~Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.~Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.~There was a 7 days washout period between each administration."
11340010|NCT03644095|OG000|Outcome|Test (Treatment A)|Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
11340011|NCT03644095|OG001|Outcome|Reference (Treatment B)|Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
11340012|NCT03644095|EG000|Reported Event|Test (Treatment A)|Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
11340013|NCT03644095|EG001|Reported Event|Reference (Treatment B)|Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
11340019|NCT03644173|FG000|Participant Flow|Personal Resilience Empowerment Program|Participants who were enrolled and completed all visits
11340109|NCT03646305|FG001|Participant Flow|Sing Negative Body-related Thoughts|"A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340110|NCT03646305|FG002|Participant Flow|Verbally Repeat Body-unrelated Thoughts|"A control condition in which participants repeat the phrase I am talking out loud and as quickly as possible for 60 seconds."
11340111|NCT03646305|FG003|Participant Flow|Sing Body-unrelated Thoughts|"A control condition in which participants sing the phrase I am singing to the tune of 'twinkle, twinkle' for 60 seconds"
11340112|NCT03646305|OG000|Outcome|Verbally Repeat Body-related Thoughts|"A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340113|NCT03646305|OG001|Outcome|Sing Negative Body-related Thoughts|"A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340114|NCT03646305|OG002|Outcome|Verbally Repeat Body-unrelated Thoughts|"A control condition in which participants repeat the phrase I am talking out loud and as quickly as possible for 60 seconds."
11340115|NCT03646305|OG003|Outcome|Sing Body-unrelated Thoughts|"A control condition in which participants sing the phrase I am singing to the tune of 'twinkle, twinkle' for 60 seconds"
11340116|NCT03646305|OG000|Outcome|Sing Negative Body-related Thoughts|"A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340117|NCT03646305|OG001|Outcome|Verbally Repeat Body-related Thoughts|"A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340118|NCT03646305|OG002|Outcome|Sing Body-unrelated Thoughts|"A control condition in which participants sing the phrase I am singing to the tune of 'twinkle, twinkle' for 60 seconds"
11340119|NCT03646305|OG003|Outcome|Verbally Repeat Body-unrelated Thoughts|"A control condition in which participants repeat the phrase I am talking out loud and as quickly as possible for 60 seconds."
11340120|NCT03646305|EG000|Reported Event|Verbally Repeat Body-related Thoughts|"A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340121|NCT03646305|EG001|Reported Event|Sing Negative Body-related Thoughts|"A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds~Cognitive Defusion: Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought."
11340122|NCT03646305|EG002|Reported Event|Verbally Repeat Body-unrelated Thoughts|"A control condition in which participants repeat the phrase I am talking out loud and as quickly as possible for 60 seconds."
11340123|NCT03646305|EG003|Reported Event|Sing Body-unrelated Thoughts|"A control condition in which participants sing the phrase I am singing to the tune of 'twinkle, twinkle' for 60 seconds"
11340124|NCT03646656|BG000|Baseline|Reciprocal Peer Partner|Veterans with at least one cardiovascular disease risk factor who are interested in increasing heart healthy behaviors through peer support receive phone-based weekly support from a reciprocal peer support partner and as needed help from a peer coach.
11340212|NCT03649412|OG004|Outcome|Part A: MR-16h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
11340183|NCT03649412|FG001|Participant Flow|MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)|Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
11340184|NCT03649412|OG000|Outcome|Part A: IR 240 mg Fasted|Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
11340185|NCT03649412|OG000|Outcome|Part A: MR-12h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
11340186|NCT03649412|OG001|Outcome|Part A: MR-18h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
11340187|NCT03649412|OG002|Outcome|Part A: MR-16h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
11340188|NCT03649412|OG000|Outcome|Part A: MR-12h 240 mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
11340189|NCT03649412|OG001|Outcome|Part A: MR-18h 240 mg Fed (High-fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
11340190|NCT03649412|OG000|Outcome|Part A: MR-12h 240mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
11340191|NCT03649412|OG000|Outcome|Part B: MR-16h 480mg Fed (High-Fat)|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
11340192|NCT03649412|OG001|Outcome|Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
11340193|NCT03649412|OG000|Outcome|Part A: MR-18h 240mg Fed and MR-18h 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fed (high-fat) state and received MR-18h (80% release in 18 hours) tablet in fasted state
11340194|NCT03649412|OG001|Outcome|Part A: MR-12h 240mg Fed and MR-12h 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fed (high-fat) state and received MR-12h (80% release in 12 hours) tablet in fasted state
11340195|NCT03649412|OG000|Outcome|Part B: MR-16h 480mg Fed (High-fat) and MR-16h 480mg Fasted|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast in fed state and received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340196|NCT03649412|OG001|Outcome|Part B: MR-16h 480mg Fed (Standard) and MR-16h 480mg Fasted|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast in fed state and received a single oral dose of 480mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340197|NCT03649412|OG000|Outcome|Part B: MR-16h 480mg Fed (High-fat) vs MR-16h 480mg Fasted|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast in fed state and received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340198|NCT03649412|OG000|Outcome|Part B: MR-16h 960mg Fasted and MR-16h 480mg Fasted|Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340199|NCT03649412|OG001|Outcome|Part B: MR-16h 960mg Fasted vs MR-16h 120mg Fasted|Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340200|NCT03649412|OG002|Outcome|Part B: MR-16h 480mg Fasted vs MR-16h 120mg Fasted|Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340201|NCT03649412|OG000|Outcome|Part B: MR-16h 960mg Fasted vs MR-16h 480mg Fasted|Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
11340202|NCT03649412|OG000|Outcome|Part A: MR-12h 240mg Fasted and IR 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
11340203|NCT03649412|OG001|Outcome|Part A: MR-16h 240mg Fasted and IR 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received a single oral dsoe of 240 mg GSK2982772 IR tablet in fasted state
11340204|NCT03649412|OG002|Outcome|Part A: MR-18h 240mg Fasted and IR 240mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
11340205|NCT03649412|OG001|Outcome|Part A: MR-12h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
11340206|NCT03649412|OG002|Outcome|Part A: MR-18h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
11340207|NCT03649412|OG003|Outcome|Part A: MR-12h 240 mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
11340208|NCT03649412|OG004|Outcome|Part A: MR-18h 240 mg Fed (High-fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
11340209|NCT03649412|OG005|Outcome|Part A: MR-16h 240 mg Fasted|Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
11340210|NCT03649412|OG002|Outcome|Part A: MR-12h 240 mg Fed (High-Fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
11340211|NCT03649412|OG003|Outcome|Part A: MR-18h 240 mg Fed (High-fat)|Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
11340258|NCT03649932|BG000|Baseline|Low Dose|"50 mg/kg given two times a day (100 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340259|NCT03649932|BG001|Baseline|Medium Dose|"100 mg/kg given two times a day (200 mg/kg/day) for total 7 days~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340260|NCT03649932|BG002|Baseline|High Dose|"150 mg/kg given two times a day (300 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340261|NCT03649932|BG003|Baseline|Total|Total of all reporting groups
11340262|NCT03649932|FG000|Participant Flow|Low Dose|"50 mg/kg given two times a day (100 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340263|NCT03649932|FG001|Participant Flow|Medium Dose|"100 mg/kg given two times a day (200 mg/kg/day) for total 7 days~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340264|NCT03649932|FG002|Participant Flow|High Dose|"150 mg/kg given two times a day (300 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340265|NCT03649932|OG000|Outcome|Low Dose|"50 mg/kg given two times a day (100 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340266|NCT03649932|OG001|Outcome|Medium Dose|"100 mg/kg given two times a day (200 mg/kg/day) for total 7 days~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340267|NCT03649932|OG002|Outcome|High Dose|"150 mg/kg given two times a day (300 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340268|NCT03649932|EG000|Reported Event|Low Dose|"50 mg/kg given two times a day (100 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340269|NCT03649932|EG001|Reported Event|Medium Dose|"100 mg/kg given two times a day (200 mg/kg/day) for total 7 days~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340270|NCT03649932|EG002|Reported Event|High Dose|"150 mg/kg given two times a day (300 mg/kg/day) for total 7 days.~Enteral L-citrulline: L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
11340271|NCT03650192|BG000|Baseline|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."
11340272|NCT03650192|FG000|Participant Flow|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."
11340273|NCT03650192|OG000|Outcome|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."
11340274|NCT03650192|EG000|Reported Event|INVSENSOR00027 Test Group|"The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.~INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."
11340275|NCT03650387|BG000|Baseline|RADIESSE® (+) Lidocaine: All Participants|Participants received SMD (RADIESSE® [+] Lidocaine) on Day 1 with volume for each area to be treated and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations. A minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss) per participant were treated. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
11340615|NCT03661541|OG000|Outcome|6 or More Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11340616|NCT03661541|OG001|Outcome|1 to 2 Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340617|NCT03661541|OG002|Outcome|Zero Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group C: 12 subjects with zero outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0."
11340618|NCT03661541|OG000|Outcome|6 or More Herpes Labialis Outbreaks at 8 Weeks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11340619|NCT03661541|OG001|Outcome|6 or More Herpes Labialis Outbreaks at Day 1|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours."
11340620|NCT03661541|EG000|Reported Event|6 or More Herpes Labialis Outbreaks|"Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:~Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.~Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.~Group B and C subjects (having 0 or 1 to 2 outbreaks in the prior 12 months) were not treated, and therefore not at risk, and adverse event data was not collected on them.~Squaric Acid Dibutyl Ester: 2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours.~Only subjects with 6 or more herpes labialis outbreaks (Group A) were treated and therefore, only this group is included in the adverse event reporting. The patients in the zero outbreaks group and 1 to 2 outbreaks group were not treated with either drug or placebo, and therefore not at risk of adverse events, and they were not followed for adverse events and no adverse event data was collected for those groups. So, again, only subjects in Group A (6 or more outbreaks in the prior 12 months) were treated and thus at risk for adverse events, and adverse event data was collected only for that group."
11340621|NCT03661697|BG000|Baseline|Lytera Arm|"4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340622|NCT03661697|BG001|Baseline|Placebo Arm|"4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Basic Skin Care Regimen Only and Laser Therapy: Not Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340623|NCT03661697|BG002|Baseline|Total|Total of all reporting groups
11340624|NCT03661697|FG000|Participant Flow|Lytera Arm|"4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340625|NCT03661697|FG001|Participant Flow|Placebo Arm|"4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Basic Skin Care Regimen Only and Laser Therapy: Not Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340626|NCT03661697|OG000|Outcome|Lytera Arm|"4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340627|NCT03661697|OG001|Outcome|Placebo Arm|"4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.~Basic Skin Care Regimen Only and Laser Therapy: Not Combined~Lytera plus Laser: two arms of study- each with different topical cosmeceutical"
11340943|NCT03670264|BG002|Baseline|No Financial Incentive|"No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.~Way to Health (WTH) Platform: The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.~Quitline Delivered Treatment: The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls."
11340944|NCT03670264|BG003|Baseline|Total|Total of all reporting groups
11340945|NCT03670264|FG000|Participant Flow|Quitline Incentive|The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
11340946|NCT03670264|FG001|Participant Flow|Tobacco Cessation Incentive|The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
11340947|NCT03670264|FG002|Participant Flow|No Financial Incentive|"No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.~Way to Health (WTH) Platform: The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.~Quitline Delivered Treatment: The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls."
11340948|NCT03670264|OG000|Outcome|Quitline Incentive|The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
11340949|NCT03670264|OG001|Outcome|Tobacco Cessation Incentive|The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
11340950|NCT03670264|OG002|Outcome|No Financial Incentive|No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.
11340951|NCT03670264|EG000|Reported Event|Quitline Incentive|The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
11340952|NCT03670264|EG001|Reported Event|Tobacco Cessation Incentive|The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
11340953|NCT03670264|EG002|Reported Event|No Financial Incentive|"No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.~Way to Health (WTH) Platform: The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.~Quitline Delivered Treatment: The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls."
11340954|NCT03670537|BG000|Baseline|First Trimester Pregnant Women|Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
11340955|NCT03670537|FG000|Participant Flow|First Trimester Pregnant Women|Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
11340956|NCT03670537|OG000|Outcome|First Trimester Pregnant Women|Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
11340957|NCT03670537|EG000|Reported Event|First Trimester Pregnant Women|Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
11340969|NCT03670810|FG000|Participant Flow|100 Milligram (mg) Lasmiditan|Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
11341523|NCT03683719|BG000|Baseline|Delgocitinib Cream 1 mg/g|"Delgocitinib cream applied twice daily for 16 weeks.~Delgocitinib cream: Cream for topical application."
11340958|NCT03670641|BG000|Baseline|Insulin and CGM Intervention|"10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission.~Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved."
11340959|NCT03670641|FG000|Participant Flow|Insulin and CGM Intervention|"10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission.~Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved."
11340960|NCT03670641|OG000|Outcome|Insulin and CGM Intervention|"10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission.~Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved."
11340961|NCT03670641|OG000|Outcome|# of Participants With A1C <6.5%|This outcome determined the total number of participants that achieved A1C <6.5% at each 3 month interval up until conclusion of study at 12 months
11340962|NCT03670641|OG000|Outcome|# of Participants Who Had a Continuous Glucose Reading <55mg/dL During Insulin Intervention Week|This was to capture if any of the participants had severe hypoglycemia, defined as <55mg/dL, during the 4 week insulin intervention.
11340963|NCT03670641|OG000|Outcome|# of Participants Achieving Glucose Targets|"In this secondary outcome, we wanted to quantify the number of participants able to achieve a pre-specified fasting glucose of <95mg/dL within the first two weeks of insulin therapy. We also wanted to quantify the number of participants able to achieve a pre-specified 2 hour post-prandial glucose target of <120mg/dL within the first two weeks of insulin therapy.~secondary outcome goals was for participants to be able to achieve fasting glucose levels <95mg/dL within two weeks of the CGM-guided insulin intervention. We report the number of participants who were able to do so~One participant didn't titrate the insulin dose, one participant was lost to follow up, and two did not achieve goal fasting glucose in the first two weeks of therapy"
11340964|NCT03670641|EG000|Reported Event|Insulin and CGM Intervention|"10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission.~Glargine: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Lispro: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.~Dexcom G6: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved."
11340965|NCT03670810|BG000|Baseline|100 mg Lasmiditan|Participants received 1-100 mg Lasmiditan tablet with 1-50 mg Lasmiditan matching placebo tablet and 1-100-mg Lasmiditan matching placebo tablet to maintain blind.
11340966|NCT03670810|BG001|Baseline|200 mg Lasmiditan|Participants received 2-100 mg Lasmiditan tablets with 1-50 mg Lasmiditan matching placebo tablet to maintain blind.
11340967|NCT03670810|BG002|Baseline|Control|"Control 1: Participants received 1-50 mg Lasmiditan matching placebo tablet and 2-100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.~Participants received 1-50 mg Lasmiditan tablet with 2-100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.~Control 2: Participants received 1-50 mg Lasmiditan matching placebo tablet and 2-100 mg Lasmiditan matching placebo tablets to treat migraine attacks 1, 2 and 3.~Participants received 1-50 mg Lasmiditan tablet and 2-100 mg Lasmiditan matching placebo tablets to treat migraine attack 4."
11340968|NCT03670810|BG003|Baseline|Total|Total of all reporting groups
11341130|NCT03675776|EG001|Reported Event|Rapastinel 225mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341012|NCT03672396|EG000|Reported Event|Home-based Exercise|"The sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour.~Home-based exercise: The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12."
11341013|NCT03673670|BG000|Baseline|Low Dose RPL554 Then High Dose RPL554 Then Placebo|1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341014|NCT03673670|BG001|Baseline|Low Dose RPL554 Then Placebo Then High Dose RPL554|1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341015|NCT03673670|BG002|Baseline|High Dose RPL554 Then Low Dose RPL554 Then Placebo|6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341016|NCT03673670|BG003|Baseline|High Dose RPL554 Then Placebo Then Low Dose RPL554|6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341017|NCT03673670|BG004|Baseline|Placebo Then Low Dose RPL554 Then High Dose RPL554|Placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341018|NCT03673670|BG005|Baseline|Placebo Then High Dose RPL554 Then Low Dose RPL554|Placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341019|NCT03673670|BG006|Baseline|Total|Total of all reporting groups
11341020|NCT03673670|FG000|Participant Flow|Low Dose RPL554 Then High Dose RPL554 Then Placebo|1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341021|NCT03673670|FG001|Participant Flow|Low Dose RPL554 Then Placebo Then High Dose RPL554|1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341022|NCT03673670|FG002|Participant Flow|High Dose RPL554 Then Low Dose RPL554 Then Placebo|6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341023|NCT03673670|FG003|Participant Flow|High Dose RPL554 Then Placebo Then Low Dose RPL554|6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341024|NCT03673670|FG004|Participant Flow|Placebo Then Low Dose RPL554 Then High Dose RPL554|Placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341025|NCT03673670|FG005|Participant Flow|Placebo Then High Dose RPL554 Then Low Dose RPL554|Placebo twice daily plus tiotropium 5/5 mcg once daily for 3 days then 6 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days then 1.5 mg RPL554 twice daily plus tiotropium 5/5 mcg once daily for 3 days with a 7-14 day washout between treatment periods
11341026|NCT03673670|OG000|Outcome|1.5 mg RPL554 and Tiotropium/Olodaterol|"1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341027|NCT03673670|OG001|Outcome|6 mg RPL554 and Tiotropium/Olodaterol|"6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341028|NCT03673670|OG002|Outcome|Placebo and Tiotropium/Olodaterol|"Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~Placebo: A placebo solution~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341029|NCT03673670|OG000|Outcome|1.5 mg RPL554 and Tiotropium/Olodaterol on Day 1|"1.5 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341030|NCT03673670|OG001|Outcome|6 mg RPL554 and Tiotropium/Olodaterol on Day 1|"6 mg RPL554 suspension administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~RPL554 Suspension: A PDE3/4 inhibitor~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341031|NCT03673670|OG002|Outcome|Placebo and Tiotropium/Olodaterol on Day 1|"Placebo administered using a nebulizer twice daily plus 5 mcg/5 mcg tiotropium/olodaterol (Respimat) administered once daily~Placebo: A placebo solution~Tiotropium/olodaterol (Respimat): An anticholinergic/β-agonist combination medication"
11341131|NCT03675776|EG002|Reported Event|Rapastinel 450mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341132|NCT03676270|BG000|Baseline|Trials|Cancer Phase 1 trials
11341058|NCT03674281|BG000|Baseline|Older Adults:Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341059|NCT03674281|BG001|Baseline|Younger Children: SAP-CLC|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341060|NCT03674281|BG002|Baseline|Parents of Young Children|Limited data were obtained on parents of young children and included actigraphy watch.
11341061|NCT03674281|BG003|Baseline|Total|Total of all reporting groups
11341062|NCT03674281|FG000|Participant Flow|Older Adults:Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341063|NCT03674281|FG001|Participant Flow|Younger Children: SAP-CLC|"SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.~SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).~CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM."
11341064|NCT03674281|FG002|Participant Flow|Parents of Young Children|Parent of Young Children. Parents wore a sleep watch.
11341065|NCT03674281|OG000|Outcome|Older Adults:Sensor Augmented Pump (SAP)|SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341066|NCT03674281|OG001|Outcome|Older Adults: Closed-Loop Control (CLC)|CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341067|NCT03674281|OG002|Outcome|Young Children: SAP|SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341068|NCT03674281|OG003|Outcome|Young Children: CLC|CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341069|NCT03674281|OG000|Outcome|Older Adults: Baseline|Baseline: prior to starting SAP
11341070|NCT03674281|OG001|Outcome|Older Adults:Sensor Augmented Pump (SAP)|SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341071|NCT03674281|OG002|Outcome|Older Adults: Closed-Loop Control (CLC)|CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341072|NCT03674281|OG003|Outcome|Young Children: Baseline|Baseline: prior to starting SAP
11341073|NCT03674281|OG004|Outcome|Young Children: SAP|SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
11341133|NCT03676270|FG000|Participant Flow|Participants Included in Phase 1 Oncology Trials|Participants included in Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015.
11341134|NCT03676270|OG000|Outcome|Phase 1 Oncology Trials|Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015.
11341089|NCT03674970|EG000|Reported Event|Random Nicotine Delivery|"One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341090|NCT03674970|EG001|Reported Event|Steady State Nicotine Delivery|"One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341091|NCT03674970|EG002|Reported Event|Placebo Control|"One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.~Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
11341092|NCT03675451|BG000|Baseline|Interventional|"Injection of study drug followed by PET/CT imaging.~Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.~Followed by prostatectomy~89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan~68Ga-PSMA-HBED-CC: Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance."
11341093|NCT03675451|FG000|Participant Flow|Interventional|"Injection of study drug followed by PET/CT imaging.~Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.~Followed by prostatectomy~89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan~68Ga-PSMA-HBED-CC: Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance."
11341094|NCT03675451|OG000|Outcome|89Zr-Df-IAB2M, mpMRI, Prostatectomy|19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy
11341095|NCT03675451|OG000|Outcome|89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy|A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
11341096|NCT03675451|OG000|Outcome|89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy|A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
11341097|NCT03675451|OG000|Outcome|89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy|A subset of 9 participants were injected with 68Ga-PSMA-HBED-CC (5±2mCi) followed by PET/CT imaging 1 to 3 hours after the injection. This preceded prostatectomy.
11341098|NCT03675451|OG000|Outcome|89Zr-Df-IAB2M, mpMRI, Prostatectomy|"19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy~A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy."
11341099|NCT03675451|OG000|Outcome|89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy|A subset of 9 participants were injected with 68Ga-PSMA-HBED-CC followed by PET/CT imaging 1 to 3 hours after the injection. This preceded prostatectomy.
11341100|NCT03675451|OG000|Outcome|89Zr-Df-IAB2M, mpMRI|"20 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging.~A subset of 19 subjects underwent prostatectomy following imaging~A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy."
11341101|NCT03675451|EG000|Reported Event|Interventional 89ZR-DF-IAB2M|89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan
11341102|NCT03675451|EG001|Reported Event|68Ga-PSMA-HBED-CC (5±2mCi)|Injection of 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
11341103|NCT03675581|BG000|Baseline|Microgynon / Microgynon + Nintedanib|"Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R).~Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T).~All treatments were to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed."
11341135|NCT03676270|EG000|Reported Event|Participants Included in Phase 1 Oncology Trials|Participants included in Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015.
11341136|NCT03676634|BG000|Baseline|0.5 mL rBV A/B|A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
11341104|NCT03675581|FG000|Participant Flow|Microgynon / Microgynon + Nintedanib|"Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R).~Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T).~All treatments were to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed."
11341105|NCT03675581|OG000|Outcome|Microgynon Alone (Reference Treatment, R)|"Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R).~The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed."
11341106|NCT03675581|OG001|Outcome|Microgynon + Nintedanib (Test Treatment, T)|"Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T).~The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed."
11341107|NCT03675581|EG000|Reported Event|Microgynon Alone (Reference Treatment, R)|"Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R).~The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed."
11341108|NCT03675581|EG001|Reported Event|Nintedanib Alone (Before Combination Treatment)|"All patients received a continuous stable dose of nintedanib, 150 mg twice daily (bid) (300 mg total per day), soft gelatine capsule from trial Day 1 for at least 10 consecutive days.~The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed."
11341109|NCT03675581|EG002|Reported Event|Microgynon + Nintedanib (Test Treatment, T)|"Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T).~The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed."
11341110|NCT03675581|EG003|Reported Event|Nintedanib Alone (After Combination Treatment)|All patients continued to receive a stable dose of nintedanib, 150 mg bid (300 mg total per day), soft gelatine capsule after the combination treatment on trial Days 12 and 13. The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed. AE's are considered to have occurred on nintedanib alone (after combination treatment) if occurring on Day 14 or later, i.e. at least 3 days after combination treatment.
11341111|NCT03675685|BG000|Baseline|CCH (Collagenase Clostridium Histolyticum)|CCH (collagenase clostridium histolyticum): A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.
11341112|NCT03675685|FG000|Participant Flow|CCH (Collagenase Clostridium Histolyticum)|CCH (collagenase clostridium histolyticum): A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.
11341113|NCT03675685|OG000|Outcome|CCH (Collagenase Clostridium Histolyticum)|CCH (collagenase clostridium histolyticum): A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.
11341114|NCT03675685|OG000|Outcome|Left Buttock|CCH 0.84 mg/Area, 3.36 mg Total
11341115|NCT03675685|OG001|Outcome|Right Buttock|CCH 0.84 mg/Area, 3.36 mg Total
11341116|NCT03675685|OG002|Outcome|Left Thigh|CCH 0.84 mg/Area, 3.36 mg Total
11341117|NCT03675685|OG003|Outcome|Right Thigh|CCH 0.84 mg/Area, 3.36 mg Total
11341118|NCT03675685|EG000|Reported Event|CCH (Collagenase Clostridium Histolyticum)|CCH (collagenase clostridium histolyticum): A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.
11341119|NCT03675776|BG000|Baseline|Placebo|Placebo (prefilled syringe, weekly IV administration).
11341120|NCT03675776|BG001|Baseline|Rapastinel 225mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341121|NCT03675776|BG002|Baseline|Rapastinel 450mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341122|NCT03675776|BG003|Baseline|Total|Total of all reporting groups
11341123|NCT03675776|FG000|Participant Flow|Placebo|Placebo (prefilled syringe, weekly IV administration).
11341124|NCT03675776|FG001|Participant Flow|Rapastinel 225mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341125|NCT03675776|FG002|Participant Flow|Rapastinel 450mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341126|NCT03675776|OG000|Outcome|Placebo|Placebo (prefilled syringe, weekly IV administration).
11341127|NCT03675776|OG001|Outcome|Rapastinel 225mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341128|NCT03675776|OG002|Outcome|Rapastinel 450mg|Rapastinel (prefilled syringe, weekly intravenous IV administration).
11341129|NCT03675776|EG000|Reported Event|Placebo|Placebo (prefilled syringe, weekly IV administration).
11341174|NCT03676972|EG000|Reported Event|All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure|"The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.~LithoVue Ureteroscope System: The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes."
11341175|NCT03677089|BG000|Baseline|ECHO Cohort|Cohorts are composed of 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
11341176|NCT03677089|FG000|Participant Flow|ECHO Cohort|Cohorts are composed of 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
11341177|NCT03677089|OG000|Outcome|Baseline|Month 0
11341178|NCT03677089|OG001|Outcome|Mid-Intervention|Month 3
11341179|NCT03677089|OG002|Outcome|Post-Intervention|Month 6
11341180|NCT03677089|OG003|Outcome|End of Follow-Up|Month 9
11341181|NCT03677089|OG000|Outcome|ECHO Cohort|Cohorts are composed of 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
11341182|NCT03677089|EG000|Reported Event|ECHO Cohort|Cohorts are composed of 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
11341183|NCT03677245|BG000|Baseline|Balance Biking|Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
11341184|NCT03677245|FG000|Participant Flow|Balance Biking|Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
11341185|NCT03677245|OG000|Outcome|Balance Biking|"Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum~Strider Balance Bike: Learning to ride a Strider balance bike"
11341186|NCT03677245|OG000|Outcome|Balance Biking|Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
11341187|NCT03677245|EG000|Reported Event|Balance Biking|Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
11341188|NCT03677375|BG000|Baseline|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.~INVSENSOR00026: Noninvasive pulse oximeter sensor"
11341189|NCT03677375|FG000|Participant Flow|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.~INVSENSOR00026: Noninvasive pulse oximeter sensor"
11341190|NCT03677375|OG000|Outcome|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.~INVSENSOR00026: Noninvasive pulse oximeter sensor"
11341191|NCT03677375|EG000|Reported Event|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026.~INVSENSOR00026: Noninvasive pulse oximeter sensor"
11341192|NCT03677401|BG000|Baseline|Placebo|Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341193|NCT03677401|BG001|Baseline|Serlopitant 5 mg|Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341194|NCT03677401|BG002|Baseline|Total|Total of all reporting groups
11341195|NCT03677401|FG000|Participant Flow|Placebo|Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341196|NCT03677401|FG001|Participant Flow|Serlopitant 5 mg|Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341197|NCT03677401|OG000|Outcome|Placebo|Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341198|NCT03677401|OG001|Outcome|Serlopitant 5 mg|Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341199|NCT03677401|EG000|Reported Event|Placebo|Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341200|NCT03677401|EG001|Reported Event|Serlopitant 5 mg|Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period.
11341201|NCT03677869|BG000|Baseline|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11341202|NCT03677869|FG000|Participant Flow|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11341203|NCT03677869|OG000|Outcome|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11341204|NCT03677869|EG000|Reported Event|Pneumatic Vitreolysis (PVL)|Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
11341205|NCT03678103|BG000|Baseline|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor~INVSENSOR00029: Noninvasive pulse oximeter sensor"
11341206|NCT03678103|FG000|Participant Flow|Test Subject|"All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor~INVSENSOR00029: Noninvasive pulse oximeter sensor"
11341497|NCT03682965|BG000|Baseline|Intra-lymphatic Allergenic Extract|"A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node."
11341498|NCT03682965|BG001|Baseline|Intra-lymphatic Placebo|"Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group."
11341499|NCT03682965|BG002|Baseline|Total|Total of all reporting groups
11341500|NCT03682965|FG000|Participant Flow|Intra-lymphatic Allergenic Extract|"A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node."
11341501|NCT03682965|FG001|Participant Flow|Intra-lymphatic Placebo|"Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group."
11341502|NCT03682965|OG000|Outcome|Intra-lymphatic Allergenic Extract|"A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node."
11341503|NCT03682965|OG001|Outcome|Intra-lymphatic Placebo|"Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group."
11341504|NCT03682965|EG000|Reported Event|Intra-lymphatic Allergenic Extract|"A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node."
11341505|NCT03682965|EG001|Reported Event|Intra-lymphatic Placebo|"Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.~Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group."
11341506|NCT03683576|BG000|Baseline|Placebo|Placebo QD for 24 weeks
11341507|NCT03683576|BG001|Baseline|GB001 20 mg|GB001 20 mg QD for 24 weeks
11341508|NCT03683576|BG002|Baseline|GB001 40 mg|GB001 40 mg QD for 24 weeks
11341509|NCT03683576|BG003|Baseline|GB001 60 mg|GB001 60 mg QD for 24 weeks
11341510|NCT03683576|BG004|Baseline|Total|Total of all reporting groups
11341511|NCT03683576|FG000|Participant Flow|Placebo|Placebo once per day (QD) for 24 weeks
11341512|NCT03683576|FG001|Participant Flow|GB001 20 mg|GB001 20 mg QD for 24 weeks
11341513|NCT03683576|FG002|Participant Flow|GB001 40 mg|GB001 40 mg QD for 24 weeks
11341514|NCT03683576|FG003|Participant Flow|GB001 60 mg|GB001 60 mg QD for 24 weeks
11341515|NCT03683576|OG000|Outcome|Placebo|Placebo QD for 24 weeks
11341516|NCT03683576|OG001|Outcome|GB001 20 mg|GB001 20 mg QD for 24 weeks
11341517|NCT03683576|OG002|Outcome|GB001 40 mg|GB001 40 mg QD for 24 weeks
11341518|NCT03683576|OG003|Outcome|GB001 60 mg|GB001 60 mg QD for 24 weeks
11341519|NCT03683576|EG000|Reported Event|Placebo|Placebo QD for 24 weeks
11341520|NCT03683576|EG001|Reported Event|GB001 20 mg|GB001 20 mg QD for 24 weeks
11341521|NCT03683576|EG002|Reported Event|GB001 40 mg|GB001 40 mg QD for 24 weeks
11341522|NCT03683576|EG003|Reported Event|GB001 60 mg|GB001 60 mg QD for 24 weeks
11341553|NCT03683901|BG000|Baseline|TENS/t-NMES/No Stimulation|"Electrical Stimulation-TENS: TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds.~Electrical Stimulation-t-NMES: t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain.~No stimulation: Device and electrodes remained in place but no stimulation was delivered over the 10 second interval.~Exposed to each stimulation 3 times for each shoulder ROM."
11341554|NCT03683901|FG000|Participant Flow|Hemiplegic Shoulder Pain|Cohort study; single group but with random serial allocation of treatment type (TENS/t-NMES/no stimulation)
11341555|NCT03683901|OG000|Outcome|TENS|"TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. Exposed to this arm 3 times for each shoulder ROM.~TENS: Electrical Stimulation"
11341556|NCT03683901|OG001|Outcome|t-NMES|"t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Exposed to this arm 3 times for each shoulder ROM.~t-NMES: Electrical Stimulation"
11341557|NCT03683901|OG002|Outcome|No Stimulation|"Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to this arm 3 times for each shoulder ROM.~No stimulation: No stimulation"
11341558|NCT03683901|EG000|Reported Event|Hemiplegic Shoulder Pain|"Electrical Stimulation-TENS: TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds.~Electrical Stimulation-t-NMES: t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain.~No stimulation: Device and electrodes remained in place but no stimulation was delivered over the 10 second interval.~Exposed to each stimulation 3 times for each shoulder ROM."
11341559|NCT03684044|BG000|Baseline|Baloxavir Marboxil|Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with standard of care (SOC) NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341560|NCT03684044|BG001|Baseline|Placebo|Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341561|NCT03684044|BG002|Baseline|Total|Total of all reporting groups
11341562|NCT03684044|FG000|Participant Flow|Baloxavir Marboxil|Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with standard of care (SOC) NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341563|NCT03684044|FG001|Participant Flow|Placebo|Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341564|NCT03684044|OG000|Outcome|Baloxavir Marboxil|Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with standard of care (SOC) NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341565|NCT03684044|OG001|Outcome|Placebo|Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341566|NCT03684044|EG000|Reported Event|Baloxavir Marboxil|Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with standard of care (SOC) NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341567|NCT03684044|EG001|Reported Event|Placebo|Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
11341568|NCT03684265|BG000|Baseline|Movalis® Capsules (T), Then Movalis® Tablets (R)|"Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2.~The washout period between two drug administrations was of 7 days."
11341569|NCT03684265|BG001|Baseline|Movalis® Tablets (R), Then Movalis® Capsules (T)|"Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2.~The washout period between two drug administrations was of 7 days."
11341570|NCT03684265|BG002|Baseline|Total|Total of all reporting groups
11341722|NCT03687684|FG004|Participant Flow|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341609|NCT03685344|OG003|Outcome|Dose Expansion: Loncastuximab Tesirine|"The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma.~Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.~The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated."
11341610|NCT03685344|EG000|Reported Event|Dose Escalation: Loncastuximab Tesirine 90 μg/kg|Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341611|NCT03685344|EG001|Reported Event|Dose Escalation: Loncastuximab Tesirine 120 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341612|NCT03685344|EG002|Reported Event|Dose Escalation: Loncastuximab Tesirine 150 μg/kg|Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.
11341613|NCT03685344|EG003|Reported Event|Dose Expansion: Loncastuximab Tesirine|"The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma.~Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.~The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated."
11341614|NCT03685396|BG000|Baseline|Test Group|"In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft.~Platelet rich fibrin ( PRF): Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.~At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site."
11341615|NCT03685396|BG001|Baseline|Control Group|"In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.~hemostatic agents with oxidized and regenerated cellulosa: In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0)."
11341616|NCT03685396|BG002|Baseline|Total|Total of all reporting groups
11341617|NCT03685396|FG000|Participant Flow|Test Group|"In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft.~Platelet rich fibrin ( PRF): Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.~At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site."
11341618|NCT03685396|FG001|Participant Flow|Control Group|"In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.~hemostatic agents with oxidized and regenerated cellulosa: In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0)."
11341619|NCT03685396|OG000|Outcome|Test Group|"In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft.~Platelet rich fibrin ( PRF): Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.~At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site."
11341620|NCT03685396|OG001|Outcome|Control Group|"In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.~hemostatic agents with oxidized and regenerated cellulosa: In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0)."
11341644|NCT03685968|EG002|Reported Event|King Vision Non-Channeled (Standard) VL|Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
11341621|NCT03685396|EG000|Reported Event|Test Group|"In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft.~Platelet rich fibrin ( PRF): Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.~At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site."
11341622|NCT03685396|EG001|Reported Event|Control Group|"In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.~hemostatic agents with oxidized and regenerated cellulosa: In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0)."
11341623|NCT03685643|BG000|Baseline|Intervention|The intervention materials were developed with high peer engagement and included four short videos, an interactive scenario game and a risk assessment tool.
11341624|NCT03685643|BG001|Baseline|Control|An existing website promoting physical activities and healthy living was served as a control.
11341625|NCT03685643|BG002|Baseline|Total|Total of all reporting groups
11341626|NCT03685643|FG000|Participant Flow|Intervention|The intervention materials were developed with high peer engagement and included four short videos, an interactive scenario game and a risk assessment tool.
11341627|NCT03685643|FG001|Participant Flow|Control|An existing website promoting physical activities and healthy living was served as a control.
11341628|NCT03685643|OG000|Outcome|Intervention - Dating Application Topic|"The intervention will consist of four short videos with points of discussion, a scenario game, and a risk assessment tool regarding dating application usage.~Intervention - Dating application topic: The intervention will consist of multimedia content to promote the safe usage of dating applications and raise awareness of the risks associated with dating application usage. The intervention will be delivered one-time in a classroom setting."
11341629|NCT03685643|OG001|Outcome|Control - Health and Exercise Topic|"The control will consist of four short videos with discussion points and an interaction game regarding exercise and healthy living tips.~Control - Health and exercise topic: The placebo control will consist of multimedia content regarding exercise and healthy living. It will be delivered once-time in a classroom setting."
11341630|NCT03685643|EG000|Reported Event|Intervention|The intervention materials were developed with high peer engagement and included four short videos, an interactive scenario game and a risk assessment tool.
11341631|NCT03685643|EG001|Reported Event|Control|An existing website promoting physical activities and healthy living was served as a control.
11341632|NCT03685968|BG000|Baseline|Glidescope AVL|Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
11341633|NCT03685968|BG001|Baseline|King Vision Channeled VL|Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
11341634|NCT03685968|BG002|Baseline|King Vision Non-Channeled (Standard) VL|Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
11341635|NCT03685968|BG003|Baseline|Total|Total of all reporting groups
11341636|NCT03685968|FG000|Participant Flow|Glidescope AVL|Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
11341637|NCT03685968|FG001|Participant Flow|King Vision Channeled VL|Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
11341638|NCT03685968|FG002|Participant Flow|King Vision Non-Channeled (Standard) VL|Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
11341639|NCT03685968|OG000|Outcome|Glidescope AVL|Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
11341640|NCT03685968|OG001|Outcome|King Vision Channeled VL|Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
11341641|NCT03685968|OG002|Outcome|King Vision Non-Channeled (Standard) VL|Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
11341642|NCT03685968|EG000|Reported Event|Glidescope AVL|Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
11341643|NCT03685968|EG001|Reported Event|King Vision Channeled VL|Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
11341645|NCT03686033|BG000|Baseline|Overall Participants|Participants received E2082-matched placebo (Treatment A) or E2082 2.5 mg (Treatment B) or E2082 25 mg (Treatment C) and E2082 40 mg tablet, orally, once on Day 1 in Treatment Period 1 to 4 as per assigned treatment sequence. A washout phase of at least 2 weeks was maintained between all the treatment periods.
11341699|NCT03687450|BG000|Baseline|Intervention (Yoga) Arm|"This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.~RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga & Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."
11341700|NCT03687450|BG001|Baseline|No-treatment Control Arm|This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
11341701|NCT03687450|BG002|Baseline|Total|Total of all reporting groups
11341702|NCT03687450|FG000|Participant Flow|Intervention (Yoga) Arm|"This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.~RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga & Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."
11341703|NCT03687450|FG001|Participant Flow|No-treatment Control Arm|This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
11341704|NCT03687450|OG000|Outcome|Intervention (Yoga) Arm|"This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.~RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga & Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."
11341705|NCT03687450|OG001|Outcome|No-treatment Control Arm|This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
11341706|NCT03687450|EG000|Reported Event|Intervention (Yoga) Arm|"This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.~RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga & Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."
11341707|NCT03687450|EG001|Reported Event|No-treatment Control Arm|This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
11341708|NCT03687684|BG000|Baseline|Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341709|NCT03687684|BG001|Baseline|Japanese Cohort 1-B: TAK-831 100 mg + Placebo|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341710|NCT03687684|BG002|Baseline|Japanese Cohort 1-C: Placebo + TAK-831 300 mg|TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341711|NCT03687684|BG003|Baseline|Japanese Cohort 2, 4 and 5: Pooled Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341712|NCT03687684|BG004|Baseline|Japanese Cohort 2: TAK-831 300 mg|TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341713|NCT03687684|BG005|Baseline|Japanese Cohort 4: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341714|NCT03687684|BG006|Baseline|Japanese Cohort 5: TAK-831 50 mg|TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341715|NCT03687684|BG007|Baseline|Chinese Cohort 3: Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341716|NCT03687684|BG008|Baseline|Chinese Cohort 3: TAK-831 600 mg|TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
11341717|NCT03687684|BG009|Baseline|Total|Total of all reporting groups
11341718|NCT03687684|FG000|Participant Flow|Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg|TAK-831 100 milligram (mg), tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341719|NCT03687684|FG001|Participant Flow|Japanese Cohort 1-B: TAK-831 100 mg + Placebo|TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341720|NCT03687684|FG002|Participant Flow|Japanese Cohort 1-C: Placebo + TAK-831 300 mg|TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
11341721|NCT03687684|FG003|Participant Flow|Japanese Cohort 2, 4 and 5: Pooled Placebo|TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
11341841|NCT03689504|BG001|Baseline|Home Garden Intervention|"This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method."
11341842|NCT03689504|BG002|Baseline|Total|Total of all reporting groups
11341843|NCT03689504|FG000|Participant Flow|Standard of Care|"The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents."
11341844|NCT03689504|FG001|Participant Flow|Home Garden Intervention|"This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method."
11341845|NCT03689504|OG000|Outcome|Standard of Care|"The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents."
11341846|NCT03689504|OG001|Outcome|Home Garden Intervention|"This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method."
11341847|NCT03689504|EG000|Reported Event|Standard of Care|"The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents."
11341848|NCT03689504|EG001|Reported Event|Home Garden Intervention|"This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)~Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)~Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.~Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method."
11341849|NCT03690375|BG000|Baseline|BBL Treatment|One arm was randomly selected to receive treatment with Sciton's BBL with multiple passes using a new protocol with varying filters and settings.
11341850|NCT03690375|BG001|Baseline|No Treatment|One arm was not treated
11341851|NCT03690375|BG002|Baseline|Total|Total of all reporting groups
11341852|NCT03690375|FG000|Participant Flow|BBL Treatment|One arm was randomly selected to receive treatment with Sciton's BBL according to a protocol with multiple passes with different filters and settings.
11341853|NCT03690375|FG001|Participant Flow|No Treatment|One arm was not treated
11341854|NCT03690375|OG000|Outcome|BBL Treatment|One arm was randomly selected to receive treatment with Sciton's BBL
11341855|NCT03690375|OG001|Outcome|No Treatment|One arm was not treated
11341856|NCT03690375|OG000|Outcome|BBL Treatment Senile Purpura|One arm was randomly selected to receive treatment with Sciton's BBL in those with senile purpura
11341857|NCT03690375|OG001|Outcome|No Treatment Senile Purpura|One arm was not treated in those with senile purpura
11341858|NCT03690375|OG002|Outcome|No Treatment No Senile Purpura|Younger control participants without senile purpura
11341859|NCT03690375|EG000|Reported Event|BBL Treatment|One arm was randomly selected to receive treatment with Sciton's BBL
11341860|NCT03690375|EG001|Reported Event|No Treatment|One arm was not treated
11341861|NCT03691779|BG000|Baseline|ELX/TEZ/IVA|"Part A: Participants in Part A received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h in the treatment period for 15 days.~Part B: Participants in Part B weighing <30 kg at Day 1 received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h and participants weighing >=30 kg at Day 1 received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks."
11341862|NCT03691779|FG000|Participant Flow|Part A: ELX/TEZ/IVA|Participants in Part A received elexacaftor (ELX) 100 milligrams (mg) once daily (qd)/tezacaftor (TEZ) 50 mg qd/ivacaftor (IVA) 75 mg every 12 hours (q12h) in the treatment period for 15 days.
11342014|NCT03694925|OG001|Outcome|Combined Revision Total Knee Arthroplasty|"All revision TKA patients included in the study.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11341907|NCT03692676|BG000|Baseline|Spiriva Respimat|"The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior Spiriva Respimat use before index date~no Inhaled corticosteroids (ICS)/ Long-acting beta agonists (LABA) Fixed Dose Combination (FDC) Prescription Record (Rx) within 3 months before index date~no prior asthma Diagnosis Record (Dx) before index date~age on index date less than 18 years~on index date less than 365 days prior Up-to-standard (UTS) registration~prior Chronic Obstructive Pulmonary Disease (COPD) Dx before index date (including index date)~any prior Long-acting muscarinic antagonists (LAMA) use (including index date)"
11341908|NCT03692676|BG001|Baseline|Leukotriene Receptor Antagonist (LTRA)|"The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior LTRA use before index date~no ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341909|NCT03692676|BG002|Baseline|ICS/LABA Fixed Dose Combination (Switchers)|"The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well.~Patients will be excluded if they fulfil any of the following exclusion criteria:~prior use of the same ICS/LABA FDC (evaluated on drug substance and device level) before index date~preceding ICS/LABA FDC Rx not within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341910|NCT03692676|BG003|Baseline|ICS Dose Increase of ICS/LABA Fixed Dose Combination User|"The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~preceding ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (incl. index date)~any prior LAMA use before index date (incl. index date)"
11341911|NCT03692676|BG004|Baseline|Total|Total of all reporting groups
11341912|NCT03692676|FG000|Participant Flow|Spiriva Respimat|"The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior Spiriva Respimat use before index date~no Inhaled corticosteroids (ICS)/ Long-acting beta agonists (LABA) Fixed Dose Combination (FDC) Prescription Record (Rx) within 3 months before index date~no prior asthma Diagnosis Record (Dx) before index date~age on index date less than 18 years~on index date less than 365 days prior Up-to-standard (UTS) registration~prior Chronic Obstructive Pulmonary Disease (COPD) Dx before index date (including index date)~any prior Long-acting muscarinic antagonists (LAMA) use (including index date)"
11341913|NCT03692676|FG001|Participant Flow|Leukotriene Receptor Antagonist (LTRA)|"The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior LTRA use before index date~no ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341914|NCT03692676|FG002|Participant Flow|ICS/LABA Fixed Dose Combination (Switchers)|"The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well.~Patients will be excluded if they fulfil any of the following exclusion criteria:~prior use of the same ICS/LABA FDC (evaluated on drug substance and device level) before index date~preceding ICS/LABA FDC Rx not within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341915|NCT03692676|FG003|Participant Flow|ICS Dose Increase of ICS/LABA Fixed Dose Combination User|"The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~preceding ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (incl. index date)~any prior LAMA use before index date (incl. index date)"
11341916|NCT03692676|OG000|Outcome|Spiriva Respimat|"The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior Spiriva Respimat use before index date~no Inhaled corticosteroids (ICS)/ Long-acting beta agonists (LABA) Fixed Dose Combination (FDC) Prescription Record (Rx) within 3 months before index date~no prior asthma Diagnosis Record (Dx) before index date~age on index date less than 18 years~on index date less than 365 days prior Up-to-standard (UTS) registration~prior Chronic Obstructive Pulmonary Disease (COPD) Dx before index date (including index date)~any prior Long-acting muscarinic antagonists (LAMA) use (including index date)"
11341917|NCT03692676|OG001|Outcome|Leukotriene Receptor Antagonist (LTRA)|"The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior LTRA use before index date~no ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341918|NCT03692676|OG002|Outcome|ICS/LABA Fixed Dose Combination (Switchers)|"The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well.~Patients will be excluded if they fulfil any of the following exclusion criteria:~prior use of the same ICS/LABA FDC (evaluated on drug substance and device level) before index date~preceding ICS/LABA FDC Rx not within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341919|NCT03692676|OG003|Outcome|ICS Dose Increase of ICS/LABA Fixed Dose Combination User|"The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~preceding ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (incl. index date)~any prior LAMA use before index date (incl. index date)"
11341920|NCT03692676|EG000|Reported Event|Spiriva Respimat|"The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior Spiriva Respimat use before index date~no Inhaled corticosteroids (ICS)/ Long-acting beta agonists (LABA) Fixed Dose Combination (FDC) Prescription Record (Rx) within 3 months before index date~no prior asthma Diagnosis Record (Dx) before index date~age on index date less than 18 years~on index date less than 365 days prior Up-to-standard (UTS) registration~prior Chronic Obstructive Pulmonary Disease (COPD) Dx before index date (including index date)~any prior Long-acting muscarinic antagonists (LAMA) use (including index date)"
11341921|NCT03692676|EG001|Reported Event|Leukotriene Receptor Antagonist (LTRA)|"The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~prior LTRA use before index date~no ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341922|NCT03692676|EG002|Reported Event|ICS/LABA Fixed Dose Combination (Switchers)|"The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well.~Patients will be excluded if they fulfil any of the following exclusion criteria:~prior use of the same ICS/LABA FDC (evaluated on drug substance and device level) before index date~preceding ICS/LABA FDC Rx not within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (including index date)~any prior LAMA use before index date (including index date)"
11341923|NCT03692676|EG003|Reported Event|ICS Dose Increase of ICS/LABA Fixed Dose Combination User|"The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date.~Patients will be excluded if they fulfill any of the following exclusion criteria:~preceding ICS/LABA FDC Rx within 3 months before index date~no prior asthma Dx before index date~age on index date less than 18 years~on index date less than 365 days prior UTS registration~prior COPD Dx before index date (incl. index date)~any prior LAMA use before index date (incl. index date)"
11341924|NCT03693625|BG000|Baseline|Parent Study: GDC-0853|Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341925|NCT03693625|BG001|Baseline|Parent Study: Placebo|Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341926|NCT03693625|BG002|Baseline|Total|Total of all reporting groups
11341927|NCT03693625|FG000|Participant Flow|Parent Study: GDC-0853|Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341928|NCT03693625|FG001|Participant Flow|Parent Study: Placebo|Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341929|NCT03693625|OG000|Outcome|Parent Study: GDC-0853|Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341930|NCT03693625|OG001|Outcome|Parent Study: Placebo|Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341931|NCT03693625|EG000|Reported Event|Parent Study: GDC-0853|Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341932|NCT03693625|EG001|Reported Event|Parent Study: Placebo|Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.
11341933|NCT03693742|BG000|Baseline|MSG, Then Placebo|"After a fasting period of 4 hours, participants first received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.~Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan."
11341966|NCT03694197|BG000|Baseline|Alirocumab 75 Q2W/Up150 Q2W|All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
11341942|NCT03693742|EG000|Reported Event|18F-DCFPyL PET/CT Scan With MSG Drink|"Food grade MSG will be dissolved in low sodium tomato juice, and administered orally before 18F-DCFPyL administration.~18F-DCFPyL PET/CT scan: Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection.~The participant will receive a bolus intravenous dose of 18F-DCFPyL.~After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void.~The PET/CT image acquisition time will be approximately 30 minutes.~MSG drink: Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection."
11341943|NCT03693742|EG001|Reported Event|18F-DCFPyL PET/CT Scan With Placebo Drink|"Regular tomato juice will be used, and administered orally before 18F-DCFPyL administration.~18F-DCFPyL PET/CT scan: Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection.~The participant will receive a bolus intravenous dose of 18F-DCFPyL.~After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void.~The PET/CT image acquisition time will be approximately 30 minutes.~Placebo drink: Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection."
11341944|NCT03693937|BG000|Baseline|Non-Melanoma Skin Cancers (NMSCs)|Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
11341945|NCT03693937|FG000|Participant Flow|Non-Melanoma Skin Cancers (NMSCs)|Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
11341946|NCT03693937|OG000|Outcome|Non-Melanoma Skin Cancers (NMSCs)|Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
11341947|NCT03693937|EG000|Reported Event|Non-Melanoma Skin Cancers (NMSCs)|Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
11341948|NCT03693950|BG000|Baseline|BCD-066 1 µg/kg|"Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg"
11341949|NCT03693950|BG001|Baseline|Aranesp 1 µg/kg|"Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg"
11341950|NCT03693950|BG002|Baseline|Total|Total of all reporting groups
11341951|NCT03693950|FG000|Participant Flow|BCD-066 1 µg/kg|"Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg"
11341952|NCT03693950|FG001|Participant Flow|Aranesp 1 µg/kg|"Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg"
11341953|NCT03693950|OG000|Outcome|BCD-066 1 µg/kg|"Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg"
11341954|NCT03693950|OG001|Outcome|Aranesp 1 µg/kg|"Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg"
11341955|NCT03693950|EG000|Reported Event|BCD-066 1 µg/kg|"Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg"
11341956|NCT03693950|EG001|Reported Event|Aranesp 1 µg/kg|"Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.~Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg"
11341957|NCT03693989|BG000|Baseline|PRO-145.|"Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator."
11341958|NCT03693989|BG001|Baseline|Prednefrin|"Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.~Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.~- Route of administration: topical ophthalmic"
11341959|NCT03693989|BG002|Baseline|Total|Total of all reporting groups
11341960|NCT03693989|FG000|Participant Flow|PRO-145.|"Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator."
11341961|NCT03693989|FG001|Participant Flow|Prednefrin|"Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.~Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.~- Route of administration: topical ophthalmic"
11341962|NCT03693989|OG000|Outcome|PRO-145.|"Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator."
11341963|NCT03693989|OG001|Outcome|Prednefrin|"Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.~Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.~- Route of administration: topical ophthalmic"
11341964|NCT03693989|EG000|Reported Event|PRO-145.|"Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.~Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator."
11341965|NCT03693989|EG001|Reported Event|Prednefrin|"Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.~Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.~- Route of administration: topical ophthalmic"
11341990|NCT03694613|BG000|Baseline|Placental/Umbilical Cord Blood Sample|"Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.~Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood."
11341991|NCT03694613|FG000|Participant Flow|Placental/Umbilical Cord Blood Samples|"Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited.~Placental/Umbilical Cord Blood sample: After an infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using a vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood."
11341992|NCT03694613|OG000|Outcome|Placental/Umbilical Cord Blood Sample|"Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited.~Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood."
11341993|NCT03694613|OG000|Outcome|WBC- INFANT BLOOD|Blood was taken from all 65 Infants after birth
11341994|NCT03694613|OG000|Outcome|I/T Ratio. INFANT BLOOD|Blood took from infant
11341995|NCT03694613|OG000|Outcome|CRP- INFANT BLOOD|Blood took from infant
11341996|NCT03694613|OG000|Outcome|IL-6 - INFANT BLOOD|Blood was taken from all 65 Infants from placenta and from baby 6 hours after birth
11341997|NCT03694613|OG000|Outcome|Procalcitonin - PUBC|Blood was taken from PUCB
11341998|NCT03694613|OG000|Outcome|Procalcitonin - Infant's Blood|Blood was taken from the Infant's Blood
11341999|NCT03694613|OG000|Outcome|PRESEPSIN- PUCB|Blood took from PUCB
11342000|NCT03694613|OG000|Outcome|PRESEPSIN- INFANTS BLOOD|Blood took from INFANTS BLOOD
11342001|NCT03694613|OG000|Outcome|Number of Infant's Blood Cultures|Blood is taken from infants after birth,
11342002|NCT03694613|EG000|Reported Event|Placental/Umbilical Cord Blood Sample|"Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited.~Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood."
11342003|NCT03694925|BG000|Baseline|Primary Total Knee Arthroplasty|"Primary TKA patients included in the study, to provide a baseline level for calprotectin.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342004|NCT03694925|BG001|Baseline|Aseptic Revision Total Knee Arthroplasty|"Aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342005|NCT03694925|BG002|Baseline|Revision Septic Total Knee Arthroplasty|"Septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342006|NCT03694925|BG003|Baseline|Total|Total of all reporting groups
11342007|NCT03694925|FG000|Participant Flow|Primary Total Knee Arthroplasty|"Primary TKA patients included in the study, to provide a baseline level for calprotectin.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342008|NCT03694925|FG001|Participant Flow|Aseptic Revision Total Knee Arthroplasty|"Aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342009|NCT03694925|FG002|Participant Flow|Revision Septic Total Knee Arthroplasty|"Septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342010|NCT03694925|OG000|Outcome|Primary Total Knee Arthroplasty|"There will be n=30 primary TKA patients included in the study, to provide a baseline level for calprotectin.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342011|NCT03694925|OG001|Outcome|Aseptic Revision Total Knee Arthroplasty|"There will be n=70 aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342012|NCT03694925|OG002|Outcome|Revision Septic Total Knee Arthroplasty|"There will be n=50 septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342013|NCT03694925|OG000|Outcome|Primary Total Knee Arthroplasty|"Primary TKA patients included in the study, to provide a baseline level for calprotectin.~Calprotectin test: Calprotectin will be measured both by ELISA and point of care test."
11342038|NCT03695393|BG000|Baseline|Intervention- ACT Therapy|"Participants randomized to this group will receive three ACT sessions over 1 month~ACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation."
11342039|NCT03695393|BG001|Baseline|Standard of Care|Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
11342040|NCT03695393|BG002|Baseline|Total|Total of all reporting groups
11342041|NCT03695393|FG000|Participant Flow|Intervention- Acceptance and Commitment Therapy (ACT)|"Participants randomized to this group will receive three ACT sessions over 1 month~Acceptance and Commitment Therapy (ACT): The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation."
11342042|NCT03695393|FG001|Participant Flow|Standard of Care|Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
11342043|NCT03695393|OG000|Outcome|Intervention- ACT Therapy|"Participants randomized to this group will receive three ACT sessions over 1 month~ACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation."
11342044|NCT03695393|OG001|Outcome|Standard of Care|Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
11342045|NCT03695393|EG000|Reported Event|Intervention- ACT Therapy|"Participants randomized to this group will receive three ACT sessions over 1 month~ACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation."
11342046|NCT03695393|EG001|Reported Event|Standard of Care|Participants in the control group will receive standard care as normally provided to patients by civil society organizations.
11342047|NCT03695913|BG000|Baseline|Normal Diet + CGM Then Low Carb + CGM|For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
11342048|NCT03695913|FG000|Participant Flow|Normal Diet + CGM, Then Low Carb + CGM|For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
11342049|NCT03695913|OG000|Outcome|Normal Diet + CGM Then Low Carb + CGM|For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
11342050|NCT03695913|EG000|Reported Event|Normal Diet + CGM Then Low Carb + CGM|For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
11342051|NCT03696108|BG000|Baseline|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks
11342052|NCT03696108|BG001|Baseline|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
11342053|NCT03696108|BG002|Baseline|Total|Total of all reporting groups
11342054|NCT03696108|FG000|Participant Flow|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks
11342055|NCT03696108|FG001|Participant Flow|Gefapixant 45 mg BID|Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
11342056|NCT03696108|OG000|Outcome|Gefapixant 15 mg BID|Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks
11342057|NCT03696108|OG001|Outcome|Gefapixant 45 mg|Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
11342091|NCT03696758|BG000|Baseline|Young Adults Born Premature|"Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.~Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)"
11342092|NCT03696758|FG000|Participant Flow|Sildenafil Followed by Metoprolol|Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.
11342093|NCT03696758|FG001|Participant Flow|Metoprolol Followed by Sildenafil|Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.
11342094|NCT03696758|OG000|Outcome|Young Adults Born Premature|"Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.~Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)"
11342095|NCT03696758|OG000|Outcome|Young Adults Born Premature|"Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.~Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart~Metoprolol: Subjects will receive intravenous metoprolol~Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)"
11342096|NCT03696758|EG000|Reported Event|Sildenafil Followed by Metoprolol|"Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.~Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.~Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm~Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart~Metoprolol: Subjects will receive intravenous metoprolol~Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)"
11342097|NCT03696758|EG001|Reported Event|Metoprolol Followed by Sildenafil|Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.
11342098|NCT03697083|BG000|Baseline|Reminders Through Association Arm|"participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription.~Reminders Through Association: Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue."
11342099|NCT03697083|BG001|Baseline|Active Control Arm|"Participants will be asked to think about where they will store their prescription.~Active Control: Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup."
11342100|NCT03697083|BG002|Baseline|Baseline Control Arm|"Participants are thanked for enrolling in the reminder program.~Baseline Control: Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further."
11342101|NCT03697083|BG003|Baseline|Total|Total of all reporting groups
11342102|NCT03697083|FG000|Participant Flow|Reminders Through Association Arm|"participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription.~Reminders Through Association: Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue."
11342115|NCT03697252|BG000|Baseline|KarXT|"Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7).~On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period."
11342116|NCT03697252|BG001|Baseline|Placebo|Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
11342117|NCT03697252|BG002|Baseline|Total|Total of all reporting groups
11342118|NCT03697252|FG000|Participant Flow|KarXT|Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
11342119|NCT03697252|FG001|Participant Flow|Placebo|Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
11342120|NCT03697252|OG000|Outcome|KarXT|Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
11342121|NCT03697252|OG001|Outcome|Placebo|Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
11342122|NCT03697252|EG000|Reported Event|KarXT|"Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7).~On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period."
11342123|NCT03697252|EG001|Reported Event|Placebo|Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
11342124|NCT03697460|BG000|Baseline|INCB018424|"Subjects applied INCB018424 topically, twice daily.~INCB018424 Cream~INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP."
11342125|NCT03697460|FG000|Participant Flow|INCB018424|"Subjects applied INCB018424 topically, twice daily.~INCB018424 Cream~INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP."
11342126|NCT03697460|OG000|Outcome|INCB018424|"Subjects applied INCB018424 topically, twice daily.~INCB018424 Cream~INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP."
11342127|NCT03697460|EG000|Reported Event|INCB018424|"Subjects applied INCB018424 topically, twice daily.~INCB018424 Cream~INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP."
11342128|NCT03697993|BG000|Baseline|Strategy 1|"Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342129|NCT03697993|BG001|Baseline|Strategy 2|"Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Fosfomycin 3 grams oral powder once daily (Strategy 2 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342130|NCT03697993|BG002|Baseline|Total|Total of all reporting groups
11342131|NCT03697993|FG000|Participant Flow|Strategy 1|"Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342132|NCT03697993|FG001|Participant Flow|Strategy 2|"Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Fosfomycin 3 grams oral powder once daily (Strategy 2 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342133|NCT03697993|OG000|Outcome|Strategy 1|"Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342134|NCT03697993|OG001|Outcome|Strategy 2|"Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.~Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).~Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:~Fosfomycin 3 grams oral powder once daily (Strategy 2 only)~Amoxicillin-clavulanate 875/125 mg oral tablet twice daily~Cefixime 400 mg oral tablet once daily~Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily"
11342135|NCT03697993|EG000|Reported Event|Fosfomycin|Fosfomycin was administered orally as a single 3 gram dose sachet once daily for normal kidney function or every other day for CrCl less than or equal to 20 mL/min.
11342136|NCT03697993|EG001|Reported Event|Levofloxacin|Levofloxacin was administered orally as 750 mg tablet once daily for normal kidney function, 750 mg tablet every other day for CrCl 20-49 mL/min; 500 mg tablet every other day for CrCl <20 mL/min.
11342137|NCT03697993|EG002|Reported Event|Cefixime|Cefixime was administered orally as 400mg tablet or capsule once daily for normal kidney function; 260 mg of oral suspension once daily for subjects with CrCl between 21-59 mL/min; 200 mg chewable table once daily for subjects with CrCl less than or equal to 20 mL/min.
11342138|NCT03698331|BG000|Baseline|Valbenazine/Placebo|Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks.
11342139|NCT03698331|BG001|Baseline|Placebo/Placebo|Placebo administered once daily for 7 weeks.
11342140|NCT03698331|BG002|Baseline|Total|Total of all reporting groups
11342141|NCT03698331|FG000|Participant Flow|Valbenazine/Placebo|Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks.
11342142|NCT03698331|FG001|Participant Flow|Placebo/Placebo|Placebo administered once daily for 7 weeks.
11342143|NCT03698331|OG000|Outcome|Valbenazine/Placebo|Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks.
11342144|NCT03698331|OG001|Outcome|Placebo/Placebo|Placebo administered once daily for 7 weeks.
11342145|NCT03698331|EG000|Reported Event|Valbenazine/Placebo|Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks.
11342146|NCT03698331|EG001|Reported Event|Placebo/Placebo|Placebo administered once daily for 7 weeks.
11342160|NCT03699124|FG000|Participant Flow|GP 1: Two Doses of FD MVA-BN--Lot 1|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
11342147|NCT03698591|BG000|Baseline|Transcranial Magnetic Stimulation (TMS), Then Sham TMS|Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task. Thirty minutes post stimulation, experimenters will employ a A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.
11342148|NCT03698591|BG001|Baseline|Sham TMS, Then Transcranial Magnetic Stimulation|A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task. Thirty minutes post stimulation, experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates.
11342149|NCT03698591|BG002|Baseline|Total|Total of all reporting groups
11342150|NCT03698591|FG000|Participant Flow|Transcranial Magnetic Stimulation (TMS), Then Sham TMS|Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task. Thirty minutes post stimulation, experimenters will employ a sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.
11342151|NCT03698591|FG001|Participant Flow|Sham TMS, Then Transcranial Magnetic Stimulation (TMS)|Sham transcranial magnetic stimulation task: A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject. Thirty minutes post sham stimulation, experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.
11342152|NCT03698591|OG000|Outcome|Transcranial Magnetic Stimulation (TMS)|"Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.~Transcranial magnetic stimulation task: Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task."
11342153|NCT03698591|OG001|Outcome|Sham TMS|"A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.~Sham transcranial magnetic stimulation task: A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject."
11342154|NCT03698591|EG000|Reported Event|Transcranial Magnetic Stimulation (TMS)|Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.
11342155|NCT03698591|EG001|Reported Event|Sham TMS|A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.
11342156|NCT03699124|BG000|Baseline|GP 1: Two Doses of FD MVA-BN--Lot 1|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
11342157|NCT03699124|BG001|Baseline|GP 2: Two Doses of FD MVA-BN--Lot 2|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
11342158|NCT03699124|BG002|Baseline|GP 3: Two Doses of FD MVA-BN--Lot 3|"Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3~FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)"
11342159|NCT03699124|BG003|Baseline|Total|Total of all reporting groups
11342190|NCT03700671|FG001|Participant Flow|Circuit Training|"The Circuit Training (CT) group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between.~Circuit training: The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated"
11342191|NCT03700671|OG000|Outcome|High Intensity Interval Training|"High intensity interval training was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry.~High intensity interval training: Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration"
11342192|NCT03700671|OG001|Outcome|Circuit Training|"The circuit training group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between.~Circuit training: The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated"
11342193|NCT03700671|OG000|Outcome|High Intensity Interval Training|"HIIT was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry.~High intensity interval training: Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration"
11342194|NCT03700671|OG001|Outcome|Circuit Training|"The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between.~Circuit training: The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated"
11342195|NCT03700671|EG000|Reported Event|High Intensity Interval Training|"HIIT was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry.~High intensity interval training: Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration"
11342196|NCT03700671|EG001|Reported Event|Circuit Training|"The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between.~Circuit training: The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated"
11342197|NCT03700736|BG000|Baseline|Facebook|6-month post-partum weight loss intervention delivered via a private Facebook group
11342198|NCT03700736|BG001|Baseline|Traditional|6-month post-partum weight loss intervention delivered via in-person group meetings
11342199|NCT03700736|BG002|Baseline|Total|Total of all reporting groups
11342200|NCT03700736|FG000|Participant Flow|Facebook|6-month post-partum weight loss intervention delivered via a private Facebook group
11342201|NCT03700736|FG001|Participant Flow|Traditional|6-month post-partum weight loss intervention delivered via in-person group meetings
11342202|NCT03700736|OG000|Outcome|Individuals Contacted|Individuals who expressed interest in study participation
11342203|NCT03700736|OG000|Outcome|Facebook|6-month post-partum weight loss intervention delivered via a private Facebook group
11342204|NCT03700736|OG001|Outcome|Traditional|6-month post-partum weight loss intervention delivered via in-person group meetings
11342205|NCT03700736|OG000|Outcome|Facebook|6-month behavioral weight loss intervention delivered via a private Facebook group
11342206|NCT03700736|OG001|Outcome|Traditional|6-month behavioral weight loss intervention delivered via in-person group meetings
11342207|NCT03700736|EG000|Reported Event|Facebook|6-month behavioral weight loss intervention delivered via a private Facebook group
11342208|NCT03700736|EG001|Reported Event|Traditional|6-month behavioral weight loss intervention delivered via in-person group meetings
11342209|NCT03700892|BG000|Baseline|All Treated Participants|"All participants inhaled cinnamaldehyde e-liquid or Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule.~Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).~PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342210|NCT03700892|BG001|Baseline|Healthy Controls|Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
11342211|NCT03700892|BG002|Baseline|Total|Total of all reporting groups
11342265|NCT03703336|BG001|Baseline|ROTAVIN-M1 Frozen Formulation|Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
11342212|NCT03700892|FG000|Participant Flow|Cinnamaldehyde, Then PG/VG|"Participants will inhale cinnamaldehyde(CA) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.~Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).~PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342213|NCT03700892|FG001|Participant Flow|PG/VG, Then Cinnamaldehyde|"Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.~Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).~PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342214|NCT03700892|FG002|Participant Flow|Healthy Controls|Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
11342215|NCT03700892|OG000|Outcome|Cinnamaldehyde|"Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.~Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342216|NCT03700892|OG001|Outcome|PG/VG|"Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.~PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342217|NCT03700892|OG000|Outcome|E-cigarette Users|Baseline MCC scans and sputum collection performed prior to randomization.
11342218|NCT03700892|OG001|Outcome|Non-smoker/Non-vaper Healthy Controls|Baseline MCC scans and sputum collection.
11342219|NCT03700892|EG000|Reported Event|Cinnamaldehyde|"Participants who inhaled cinnamaldehyde e-liquid in either Period 1 or Period 2 as per randomization schedule.~Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342220|NCT03700892|EG001|Reported Event|PG/VG|"Participants who inhaled Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule.~PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency)."
11342221|NCT03700892|EG002|Reported Event|Healthy Controls|Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
11342222|NCT03701061|BG000|Baseline|Participants That Received AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study (NCT01910519) are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342223|NCT03701061|BG001|Baseline|Participants That Did Not Receive AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study (NCT01910519) are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342224|NCT03701061|BG002|Baseline|Total|Total of all reporting groups
11342225|NCT03701061|FG000|Participant Flow|Participants That Received AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342226|NCT03701061|FG001|Participant Flow|Participants That Did Not Receive AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342227|NCT03701061|OG000|Outcome|Participants That Received AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342228|NCT03701061|OG001|Outcome|Participants That Did Not Receive AS03 Adjuvant|"Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).~Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study"
11342266|NCT03703336|BG002|Baseline|Total|Total of all reporting groups
11342267|NCT03703336|FG000|Participant Flow|ROTAVIN Liquid Formulation|Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
11342231|NCT03701074|BG000|Baseline|Ibuprofen and Acetaminophen Arm (Intervention Arm)|"ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).~Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen"
11342232|NCT03701074|BG001|Baseline|Ibuprofen and Placebo Arm (Control Arm)|"ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.~Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo"
11342233|NCT03701074|BG002|Baseline|Total|Total of all reporting groups
11342234|NCT03701074|FG000|Participant Flow|Ibuprofen and Acetaminophen Arm (Intervention Arm)|"ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).~Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen"
11342235|NCT03701074|FG001|Participant Flow|Ibuprofen and Placebo Arm (Control Arm)|"ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.~Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo"
11342236|NCT03701074|OG000|Outcome|Ibuprofen and Acetaminophen Arm (Intervention Arm)|"ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).~Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen"
11342237|NCT03701074|OG001|Outcome|Ibuprofen and Placebo Arm (Control Arm)|"ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.~Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo"
11342238|NCT03701074|EG000|Reported Event|Ibuprofen and Acetaminophen Arm (Intervention Arm)|"ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).~Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen"
11342239|NCT03701074|EG001|Reported Event|Ibuprofen and Placebo Arm (Control Arm)|"ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.~Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo"
11342240|NCT03702010|BG000|Baseline|CME - EME Branch|"After mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation (CME) with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days."
11342241|NCT03702010|BG001|Baseline|EME - CME Branch|"After mapping the search for the pain area, the neurostimulator is programmed to EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, conventional stimulation (CME) stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days."
11342242|NCT03702010|BG002|Baseline|Total|Total of all reporting groups
11342243|NCT03702010|FG000|Participant Flow|CME - EME Branch|"In this study, the conventional spinal cord stimulation method (control Branch-CME branch)~CME control group: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days."
11342244|NCT03702010|FG001|Participant Flow|EME - CME Branch|"In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)~EME experimental group: fter mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, conventional CME stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days."
11342245|NCT03702010|OG000|Outcome|CME -EME Branch|"Conventional CME: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days."
11342246|NCT03702010|OG001|Outcome|EME-CME Branch|"EVOLVE programming guide (EME): after mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days~The device is then deprogrammed and a 2-day washout period is initiated.~On day 7, CME protocol is initiated: stimulation is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days."
11342247|NCT03702010|OG000|Outcome|CME - EME Branch|Conventional spinal cord stimulation (CME) method for 5 days. Washout of 2 days. Experimental spinal cord stimulation (EME) for 5 days.
11342248|NCT03702010|OG001|Outcome|EME - CME Branch|Experimental spinal cord stimulation (EME) method for 5 days. Washout of 2 days. Conventional spinal cord stimulation (CME) for 5 days.
11342249|NCT03702010|OG000|Outcome|CME - EME Branch|CME conventional stimulation for 5 days, Washout for 2 days. EME evolve experimental stimulation for 5 days.
11342250|NCT03702010|OG001|Outcome|EME - CME Branch|EVOLVE programming guide (EME) experimental stimulation for 5 days. Washout for 2 days. Conventional stimulation (CME) for 5 days.
11342251|NCT03702010|OG000|Outcome|CME - EME|Conventional stimulation for 5 days Washout for days Experimental stimulation for 5 days
11342252|NCT03702010|OG001|Outcome|EME - CME|EVOLVE stimulation for 5 days Washout for 2 days Conventional stimulation for 5 days.
11342253|NCT03702010|EG000|Reported Event|CME - Conventional Stimulation|Conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
11342254|NCT03702010|EG001|Reported Event|EME - EVOLVE Experimental Stimulation|The neurostimulator is programmed to stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
11342255|NCT03702166|BG000|Baseline|Interventional CPT|"This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.~Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging."
11342256|NCT03702166|FG000|Participant Flow|Interventional CPT|"This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.~Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging."
11342257|NCT03702166|OG000|Outcome|Interventional CPT|"This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.~Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging."
11342258|NCT03702166|OG000|Outcome|Interventional CPT|"This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.~Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging."
11342259|NCT03702166|EG000|Reported Event|Interventional CPT|"This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.~Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging."
11342260|NCT03702608|BG000|Baseline|EluNIR 38mm|"Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - (PBMA) and CarboSil®~Ridaforolimus drug"
11342261|NCT03702608|FG000|Participant Flow|EluNIR 38mm|"Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - (PBMA) and CarboSil®~Ridaforolimus drug"
11342262|NCT03702608|OG000|Outcome|EluNIR 38mm|"EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - (PBMA) and CarboSil®~Ridaforolimus drug"
11342263|NCT03702608|EG000|Reported Event|EluNIR 38mm|"Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter~Delivery System - Rapid Exchange (RX) Coronary System~Polymer matrix coating - (PBMA) and CarboSil®~Ridaforolimus drug"
11342264|NCT03703336|BG000|Baseline|ROTAVIN Liquid Formulation|Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.
11342339|NCT03705793|EG001|Reported Event|Mometasone Nasal Spray|"The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.~Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray."
11342340|NCT03706040|BG000|Baseline|Placebo|Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.
11342341|NCT03706040|BG001|Baseline|Risankizumab 150 mg|Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342342|NCT03706040|BG002|Baseline|Risankizumab 300 mg|Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342343|NCT03706040|BG003|Baseline|Total|Total of all reporting groups
11342344|NCT03706040|FG000|Participant Flow|Period A: Placebo|Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.
11342345|NCT03706040|FG001|Participant Flow|Period A: Risankizumab 150 mg|Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342346|NCT03706040|FG002|Participant Flow|Period A: Risankizumab 300 mg|Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342347|NCT03706040|FG003|Participant Flow|Period B: Placebo / Risankizumab 150 mg|Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342348|NCT03706040|FG004|Participant Flow|Period B: Placebo / Risankizumab 300 mg|Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342349|NCT03706040|FG005|Participant Flow|Period B: Risankizumab 150 mg / Risankizumab 150 mg|Participants initially randomized to 150 mg risankizumab continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342350|NCT03706040|FG006|Participant Flow|Period B: Risankizumab 300 mg / Risankizumab 300 mg|Participants initially randomized to 300 mg risankizumab continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342351|NCT03706040|OG000|Outcome|Placebo|Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.
11342352|NCT03706040|OG001|Outcome|Risankizumab 150 mg|Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342353|NCT03706040|OG002|Outcome|Risankizumab 300 mg|Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.
11342354|NCT03706040|OG000|Outcome|Placebo / Risankizumab 150 mg|Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342355|NCT03706040|OG001|Outcome|Placebo / Risankizumab 300 mg|Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342356|NCT03706040|OG002|Outcome|Risankizumab 150 mg / Risankizumab 150 mg|Participants initially randomized to 150 mg risankizumab in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342357|NCT03706040|OG003|Outcome|Risankizumab 300 mg / Risankizumab 300 mg|Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342358|NCT03706040|EG000|Reported Event|Period A: Placebo|Participants received placebo by subcutaneous injection at Week 0 and Week 4 in Period A.
11342359|NCT03706040|EG001|Reported Event|Period A: Risankizumab 150 mg|Participants received 150 mg risankizumab SC at Week 0 and Week 4 in Period A.
11342360|NCT03706040|EG002|Reported Event|Period A: Risankizumab 300 mg|Participants received 300 mg risankizumab SC at Week 0 and Week 4 in Period A.
11342361|NCT03706040|EG003|Reported Event|Period B: Placebo / Risankizumab 150 mg|Participants initially randomized to placebo received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342362|NCT03706040|EG004|Reported Event|Period B: Placebo / Risankizumab 300 mg|Participants initially randomized to placebo received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342363|NCT03706040|EG005|Reported Event|Period B: Risankizumab 150 mg / Risankizumab 150 mg|Participants initially randomized to 150 mg risankizumab in Period A received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342364|NCT03706040|EG006|Reported Event|Period B: Risankizumab 300 mg / Risankizumab 300 mg|Participants initially randomized to 300 mg risankizumab in Period A received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
11342365|NCT03706313|BG000|Baseline|Genicular Nerve Block With Bupivacaine and Dexamethasone|The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.
11342366|NCT03706313|BG001|Baseline|Genicular Nerve Block With Saline|The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
11342367|NCT03706313|BG002|Baseline|Total|Total of all reporting groups
11342368|NCT03706313|FG000|Participant Flow|Genicular Nerve Block With Bupivacaine and Dexamethasone|The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.
11342369|NCT03706313|FG001|Participant Flow|Genicular Nerve Block With Saline|The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
11342678|NCT03712917|BG002|Baseline|Flunarizine|"Flunarizine is introduced with a single dose of 10 mg/day.~Flunarizine: A calcium overload blocker agent used for migraine prophylaxis."
11342679|NCT03712917|BG003|Baseline|Total|Total of all reporting groups
11342384|NCT03706469|FG001|Participant Flow|Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)|TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342385|NCT03706469|FG002|Participant Flow|Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)|TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342386|NCT03706469|FG003|Participant Flow|Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)|TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
11342387|NCT03706469|OG000|Outcome|TAK-831 T2 50 mg Fasted|TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342388|NCT03706469|OG001|Outcome|TAK-831 T3 50 mg Fasted|TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342389|NCT03706469|OG002|Outcome|TAK-831 T2 600 mg Fasted|TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342390|NCT03706469|OG003|Outcome|TAK-831 T3 600 mg Fasted|TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342391|NCT03706469|OG004|Outcome|TAK-831 T3 600 mg Fed|TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
11342392|NCT03706469|EG000|Reported Event|TAK-831 T2 50 mg Fasted|TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342393|NCT03706469|EG001|Reported Event|TAK-831 T3 50 mg Fasted|TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342394|NCT03706469|EG002|Reported Event|TAK-831 T2 600 mg Fasted|TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342395|NCT03706469|EG003|Reported Event|TAK-831 T3 600 mg Fasted|TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
11342396|NCT03706469|EG004|Reported Event|TAK-831 T3 600 mg Fed|TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
11342397|NCT03707041|BG000|Baseline|P218 1000 mg (Oral Capsules) - Cohort 1|"Two administrations of 1000 mg P218 (capsules p.o.), 48 hours apart~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)"
11342398|NCT03707041|BG001|Baseline|P218 Placebo Oral Capsules - Cohort 1|"Two administrations of P218 placebo (capsules p.o.), 48 hours apart~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste"
11342399|NCT03707041|BG002|Baseline|P218 1000 mg (Oral Capsules) - Cohort 2|"One administration of 1000 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 1000 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342400|NCT03707041|BG003|Baseline|P218 100 mg (Oral Capsules) - Cohort 3|"One administration of 100 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 100 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (100 mg) Oral Capsules: 100 mg P218 (2 x 50 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342401|NCT03707041|BG004|Baseline|P218 Placebo Oral Capsule - Cohorts 2 and 3|"One administration of P218 placebo (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of P218 placebo (capsules p.o.), 48 hours after first administration.~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342402|NCT03707041|BG005|Baseline|Total|Total of all reporting groups
11342403|NCT03707041|FG000|Participant Flow|P218 1000 mg (Oral Capsules) - Cohort 1|"Two administrations of 1000 mg P218 (capsules p.o.), 48 hours apart~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)"
11342404|NCT03707041|FG001|Participant Flow|P218 Placebo Oral Capsules - Cohort 1|"Two administrations of P218 placebo (capsules p.o.), 48 hours apart~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste"
11342405|NCT03707041|FG002|Participant Flow|P218 1000 mg (Oral Capsules) - Cohort 2|"One administration of 1000 mg P218 (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of 1000 mg P218 (capsules p.o.), 48 hours after first administration.~P218 (1000 mg) Oral Capsules: 1000 mg P218 (4 x 250 mg capsules)~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342406|NCT03707041|FG003|Participant Flow|P218 Placebo Oral Capsules - Cohort 2|"One administration of P218 placebo (capsules p.o.), 2 hours after PfSPZ Challenge and one administration of P218 placebo (capsules p.o.,) 48 hours after first administration.~Placebo Oral Capsules: Placebo capsules matched to the P218 capsules with regard to appearance and taste~PfSPZ Challenge: 3200 P. falciparum Sporozoites by direct venous inoculation (DVI)"
11342663|NCT03712852|BG000|Baseline|PRF+CAF Treated Patients|"Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane"
11342664|NCT03712852|BG001|Baseline|SCTG+ CAF Treated Patients|"SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft"
11342665|NCT03712852|BG002|Baseline|CAF Treated Patients|"A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.~CAF treated patients: Patients will be treated by coronally advanced flap"
11342666|NCT03712852|BG003|Baseline|Total|Total of all reporting groups
11342667|NCT03712852|FG000|Participant Flow|PRF+CAF Treated Patients|"Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane"
11342668|NCT03712852|FG001|Participant Flow|SCTG+ CAF Treated Patients|"SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft"
11342669|NCT03712852|FG002|Participant Flow|CAF Treated Patients|"A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.~CAF treated patients: Patients will be treated by coronally advanced flap"
11342670|NCT03712852|OG000|Outcome|PRF+CAF Treated Patients|"Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane"
11342671|NCT03712852|OG001|Outcome|SCTG+ CAF Treated Patients|"SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft"
11342672|NCT03712852|OG002|Outcome|CAF Treated Patients|"A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.~CAF treated patients: Patients will be treated by coronally advanced flap"
11342673|NCT03712852|EG000|Reported Event|PRF+CAF Treated Patients|"Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane"
11342674|NCT03712852|EG001|Reported Event|SCTG+ CAF Treated Patients|"SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.~SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft"
11342675|NCT03712852|EG002|Reported Event|CAF Treated Patients|"A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.~CAF treated patients: Patients will be treated by coronally advanced flap"
11342676|NCT03712917|BG000|Baseline|Greater Occipital Nerve Block|"The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼ (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.~Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve."
11342677|NCT03712917|BG001|Baseline|Topiramate|"Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.~Topiramate: An antiepileptic agent used for migraine prophylaxis."
11342680|NCT03712917|FG000|Participant Flow|Greater Occipital Nerve Block|"The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼ (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.~Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve."
11342681|NCT03712917|FG001|Participant Flow|Topiramate|"Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.~Topiramate: An antiepileptic agent used for migraine prophylaxis."
11342682|NCT03712917|FG002|Participant Flow|Flunarizine|"Flunarizine is introduced with a single dose of 10 mg/day.~Flunarizine: A calcium overload blocker agent used for migraine prophylaxis."
11342683|NCT03712917|OG000|Outcome|Greater Occipital Nerve Block|"The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼ (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.~Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve."
11342684|NCT03712917|OG001|Outcome|Topiramate|"Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.~Topiramate: An antiepileptic agent used for migraine prophylaxis."
11342685|NCT03712917|OG002|Outcome|Flunarizine|"Flunarizine is introduced with a single dose of 10 mg/day.~Flunarizine: A calcium overload blocker agent used for migraine prophylaxis."
11342686|NCT03712917|EG000|Reported Event|Greater Occipital Nerve Block|"The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼ (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.~Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve."
11342687|NCT03712917|EG001|Reported Event|Topiramate|"Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.~Topiramate: An antiepileptic agent used for migraine prophylaxis."
11342688|NCT03712917|EG002|Reported Event|Flunarizine|"Flunarizine is introduced with a single dose of 10 mg/day.~Flunarizine: A calcium overload blocker agent used for migraine prophylaxis."
11342689|NCT03712930|BG000|Baseline|Pamiparib|Participants received 60 mg pamiparib orally twice daily
11342690|NCT03712930|FG000|Participant Flow|Pamiparib|Participants received 60 mg pamiparib orally twice daily
11342691|NCT03712930|OG000|Outcome|Pamiparib|Participants received 60 mg pamiparib orally twice daily
11342692|NCT03712930|EG000|Reported Event|Pamiparib|Participants received 60 mg pamiparib orally twice daily
11342693|NCT03713398|BG000|Baseline|T4C-SMI Group|The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials.
11342694|NCT03713398|BG001|Baseline|Control Group|The control group receives standard prison treatment and programming
11342695|NCT03713398|BG002|Baseline|Total|Total of all reporting groups
11342696|NCT03713398|FG000|Participant Flow|T4C-SMI Group|The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials.
11342697|NCT03713398|FG001|Participant Flow|Control Group|The control group receives standard prison treatment and programming
11342698|NCT03713398|OG000|Outcome|T4C-SMI Group|The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials.
11342699|NCT03713398|OG001|Outcome|Control Group|The control group receives standard prison treatment and programming
11342700|NCT03713398|EG000|Reported Event|T4C-SMI Group|The research intervention is Thinking for Change for prisoners with mental illness (T4C-MI). This intervention has two components. The first component is Thinking for a Change (T4C), a CBT based group intervention that includes three treatment modules delivered over the course of 25-sessions in a closed-group format to 8-12 people up to twice a week over 12-14 weeks. The second component of T4C-MI is the Targeted Service Delivery Approach (TSDA) that this research team developed for use during the delivery of T4C to compensate for the impact of the neurocognitive and social impairments associated with mental illness on participants' ability to fully engage in and understand T4C's intervention materials.
11342701|NCT03713398|EG001|Reported Event|Control Group|The control group receives standard prison treatment and programming
